APEX STANDARDS ENTERPRISE
Pseudo Claim Charting for Invalidity Checks


Patent: US10533994B2*
Filed: 2006-03-24
Issued: 2020-01-14
Original Patent Holder: (Original Assignee) Theranos IP Co LLC     (Current Assignee) Theranos IP Co LLC
Inventor(s): Elizabeth A. Holmes, Shaunak Roy, Ian Gibbons, Shize Daniel Qi, Edmond Ku, Chris Todd, Melissa Takahashi, Bruce Johnson, Jeff Fenton, Keith Moravick, Uwe Springborn, Anthony Delacruz

Title: Systems and methods of sample processing and fluid control in a fluidic system

Abstract: This invention is in the field of medical devices. Specifically, the present invention provides portable medical devices that allow real-time detection of analytes from a biological fluid. The methods and devices are particularly useful for providing point-of-care testing for a variety of medical applications.

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* References: Unified Patents, Prior Art published on Theranos patents now asserted by Fortress/Softbank against medical diagnostic companies (May 7, 2020), as well as, the Open Covid Pledge.

Disclaimer: Pseudo Claim Charting (PCC) provides aggressive mapping between a target patent's claim elements and other documents (potential technical standard contents or prior arts), therefore allowing for a top-down, apriori due diligence, with which, stakeholders can assess standard essentiality (potential strengths) or invalidity (potential weaknesses) quickly and effectively. PCC may relieve partial burden of proof but is NOT a litigation-ready work product.

Click on respective references to view claim charts.

Ground	References	Title	Term Nuances	Challenged Claims
				1	2	3	4	5	6	8	9	10	13	14	15	16	17	18
1	US5842787A (Anne R. Kopf-Sill, 1998)	Microfluidic systems incorporating varied channel dimensions	▪ fluid communication ≈ fluid communication	X
2	US5885470A (John Wallace Parce, 1999)	Controlled fluid transport in microfabricated polymeric substrates	▪ fluid communication ≈ fluid communication	X
3	US5876675A (Colin B. Kennedy, 1999)	Microfluidic devices and systems	▪ fluid communication ≈ fluid communication	X
4	US6046056A (J. Wallace Parce, 2000)	High throughput screening assay systems in microscale fluidic devices	▪ metering channel, metering element, sealing element ≈ said second component ▪ sealing member ≈ fluid control system	X	X							X		X	X
5	US6440725B1 (Farzad Pourahmadi, 2002)	Integrated fluid manipulation cartridge	▪ fluid communication ≈ fluid communication ▪ reagent chamber ≈ reagent chamber	X							X	X
6	US6174675B1 (Calvin Y. H. Chow, 2001)	Electrical current for controlling fluid parameters in microchannels	▪ port engaging pressure means ≈ cross sectional area				X
7	US20030212379A1 (Adam Bylund, 2003)	Systems and methods for remotely controlling medication infusion and analyte monitoring	▪ fluid communication ≈ fluid communication	X
8	US20050054078A1 (Cary Miller, 2005)	Immunoassay device with improved sample closure	▪ bodily fluid sample, bodily fluid ≈ sample collection device ▪ fluid communication ≈ fluid communication ▪ tight seal ≈ tight seal	X										X			X
9	US6491666B1 (John T. Santini, 2002)	Microfabricated devices for the delivery of molecules into a carrier fluid	▪ fluid communication ≈ fluid communication ▪ mixing chamber ≈ mixing chamber	X				X
10	US20040005582A1 (Edward Shipwash, 2004)	Biospecific desorption microflow systems and methods for studying biospecific interactions and their modulators	▪ assay assembly, sealing element ≈ amino acid sequence	X						X	X	X		X		X
11	US6591124B2 (Faiz Feisal Sherman, 2003)	Portable interstitial fluid monitoring system	▪ metering element ≈ electrical energy source ▪ open position, pressure means ≈ said second side, said first side ▪ communication assembly ≈ said main body	X	X	X	X
12	US5939291A (Zvi Loewy, 1999)	Microfluidic method for nucleic acid amplification	▪ detection assembly ≈ target nucleic acids	X
13	US6267858B1 (J. Wallace Parce, 2001)	High throughput screening assay systems in microscale fluidic devices	▪ fluid communication ≈ fluid communication	X
14	US20030061687A1 (Carl Hansen, 2003)	High throughput screening of crystallization materials	▪ fluid communication ≈ fluid communication	X
15	US5273905A (Uwe R. Muller, 1993)	Processing of slide mounted material	▪ sealing member ≈ said holding means ▪ tight seal ≈ tight seal											X	X
16	US20030069560A1 (Anthony Adamis, 2003)	Implantable drug delivery device and use thereof	▪ permits fluid communication ≈ spaced apart relation	X
17	US20020143437A1 (Kalyan Handique, 2002)	Methods and systems for control of microfluidic devices	▪ permits fluid communication ≈ more internal components	X
18	US6664104B2 (Farzad Pourahmadi, 2003)	Device incorporating a microfluidic chip for separating analyte from a sample	▪ detection assembly, communication assembly ≈ electrically conductive material ▪ bodily fluid sample, assay assembly, pressure means, assay reagent, bodily fluid, port engaging pressure means ≈ controlling fluid flow, second flow path ▪ fluid communication ≈ fluid communication	X			X			X	X	X				X	X
19	US20020034757A1 (Roger Cubicciotti, 2002)	Single-molecule selection methods and compositions therefrom	▪ reaction site ≈ drug delivery systems	X								X
20	US6632216B2 (Peter J. Houzego, 2003)	Ingestible device	▪ port engaging pressure means ≈ cross sectional area				X
21	US20030153900A1 (John Aceti, 2003)	Autonomous, ambulatory analyte monitor or drug delivery device	▪ fluid communication ≈ fluid communication	X
22	US20040096959A1 (Matthias Stiene, 2004)	Analyte measurement	▪ detection assembly, communication assembly ≈ electrically conductive material ▪ first location ≈ electric field generator ▪ fluid communication ≈ fluid communication	X			X	X	X			X					X
23	US20020059030A1 (Michael Otworth, 2002)	Method and apparatus for the processing of remotely collected electronic information characterizing properties of biological entities	▪ sample collection ≈ sample collection	X			X	X	X			X
24	US20020055167A1 (Farzad Pourahmadi, 2002)	Device incorporating a microfluidic chip for separating analyte from a sample	▪ fluid communication ≈ fluid communication ▪ bodily fluid sample ≈ second flow path ▪ reagent chamber ≈ reagent chamber	X							X	X
25	US6368275B1 (John W. Sliwa, 2002)	Method and apparatus for diagnostic medical information gathering, hyperthermia treatment, or directed gene therapy	▪ dilution chamber, reagent chamber ≈ to receive signals				X				X	X
26	US6403338B1 (Michael Knapp, 2002)	Microfluidic systems and methods of genotyping	▪ fluid communication ≈ fluid communication	X
27	US5472603A (Carol T. Schembri, 1995)	Analytical rotor with dye mixing chamber	▪ port engaging pressure means ≈ cross sectional area				X
28	US20020187074A1 (Stephen O'Connor, 2002)	Microfluidic analytical devices and methods	▪ fluid communication ≈ fluid communication	X
29	US20050106713A1 (Brigitte Phan, 2005)	Personal diagnostic devices and related methods	▪ fluid communication ≈ fluid communication	X
30	US6893879B2 (Kurt E. Petersen, 2005)	Method for separating analyte from a sample	▪ reagent chamber ≈ reagent chamber								X	X
31	US20020042125A1 (Kurt Petersen, 2002)	Method for separating analyte from a sample	▪ fluid communication ≈ fluid communication ▪ bodily fluid sample ≈ second flow path ▪ reagent chamber ≈ reagent chamber	X							X	X
32	US20040086872A1 (Winthrop Childers, 2004)	Microfluidic system for analysis of nucleic acids	▪ reagent chamber ≈ reagent chamber								X	X
33	US6156181A (John Wallace Parce, 2000)	Controlled fluid transport microfabricated polymeric substrates	▪ sealing member ≈ fluid control system ▪ fluid communication ≈ fluid communication	X										X	X
34	US20030208133A1 (James Mault, 2003)	Breath ketone analyzer	▪ fluid communication ≈ fluid communication	X
35	US20040109793A1 (Michael McNeely, 2004)	Three-dimensional microfluidics incorporating passive fluid control structures	▪ fluid communication ≈ providing fluid communication ▪ port engaging pressure means ≈ cross sectional area ▪ open position, pressure means ≈ said second side, said first side	X		X	X							X
36	US20050100937A1 (Elizabeth Holmes, 2005)	Medical device for analyte monitoring and drug delivery	▪ bodily fluid sample, bodily fluid ≈ therapeutic agent releasing device, obtaining physical parameter data, disease marker biological analyte, biometric recognition device, analyte interaction profile, microarray scanning device, bodily fluid ▪ fluid communication ≈ fluid communication	X													X
37	US5693233A (Carol T. Schembri, 1997)	Methods of transporting fluids within an analytical rotor	▪ port engaging pressure means ≈ cross sectional area ▪ mixing chamber ≈ mixing chamber				X	X
38	US6245057B1 (Ulrich Sieben, 2001)	Device for treating malignant, tumorous tissue areas	▪ bodily fluid ≈ bodily fluid	X													X
39	JP2003166910A (Keisuke Kamisaka, 2003)	送液機構及び該送液機構を備える分析装置	▪ open position ≈ 前記プランジャ ▪ sealing element ≈ 前記隔壁, の流路	X		X						X		X
40	JP2004317498A (Yasuyuki Numajiri, 2004)	生化学反応カートリッジ及びその使用方法	▪ dilution chamber ≈ チャンバ内 ▪ bodily fluid sample ≈ 前記生 ▪ sealing element ≈ の流路	X			X					X		X
41	JP2003167960A (Ikuo Kondo, 2003)	健康管理システム	▪ open position ≈ の要求 ▪ bodily fluid sample ≈ 前記生	X		X
42	CN2559986Y (温龙平, 2003)	集成微流体和微阵列探针的微芯片	▪ bodily fluid ≈ 微流体	X													X
43	JP2005140681A (Hideaki Hisamoto, 2005)	微小流路デバイスおよびその作製方法	▪ reaction site ≈ 操作部 ▪ sealing element ≈ の流路	X								X		X
44	EP1415788A1 (Carol T. Schembri, 2004)	Integrated microfluidic array device	▪ fluid communication ≈ fluid communication	X
45	JP2001157855A (Isao Endo, 2001)	キャピラリーゲル電気泳動用マイクロチップおよびその製造方法	▪ communication assembly ≈ 前記基 ▪ sealing element ≈ の流路	X								X		X
46	JP2005291954A (Hisanobu Niimura, 2005)	使い捨て試薬パックとその試薬パックを用いる分析装置	▪ assay protocol ≈ 使い捨て ▪ metering element ≈ 開口部	X	X													X
47	JP2005010179A (Hideji Tajima, 2005)	容器	▪ communication assembly ≈ 少なくとも１ ▪ tight seal ≈ 用穴部 ▪ bodily fluid sample ≈ 該液体	X										X
48	JP2004101381A (Koichi Wakatake, 2004)	自動分析装置用の複光路セル及びこの複光路セルを用いた分析方法	▪ reaction site ≈ 該反応	X								X
49	JPH08211071A (Hideji Tajima, 1996)	自動分析装置及びその方法	▪ assay reagent ≈ インキュベーション ▪ second location ≈ 分注位置									X	X
50	EP0637998A1 (Peter Wilding, 1995)	Fluid handling in microfabricated analytical devices.	▪ sealing element ≈ system further comprises means ▪ fluid communication ≈ fluid communication ▪ sealing member ≈ said holding means	X	X							X		X	X
51	JP2003329696A (Takeshi Kono, 2003)	化学発光酵素免疫測定装置	▪ assay assembly, reader assembly, valve assembly ≈ 移動自在 ▪ reaction site ≈ 免疫反応	X						X	X	X				X
52	JPH1157560A (Masaru Nitta, 1999)	液体散布車	▪ detection assembly ≈ 検出信号 ▪ dilution chamber ≈ 水平面	X			X
53	CN1173776A (金永泽, 1998)	使用运动和空间相关的隔行向顺序转换装置和方法	▪ detection assembly ≈ 用于检测第一 ▪ reagent chamber ≈ 包括步骤	X							X	X
54	EP0640826A1 (Klaus W. Berndt, 1995)	System for detecting bacterial growth in a plurality of culture vials	▪ second location ≈ second location ▪ first location ≈ first location									X	X
55	EP0639223A1 (Larry J Kricka, 1995)	Microfabricated sperm handling devices.	▪ fluid communication ≈ fluid communication ▪ sealing member ≈ said holding means	X										X	X
56	EP0541340A2 (David H. Lloyd, 1993)	Biopolymer synthesis apparatus and method	▪ tight seal ≈ tight seal											X
57	CN1526074A (乔斯坦・霍尔特伦德, 2004)	检测系统	▪ bodily fluid sample ≈ 生物样本 ▪ sealing member ≈ 的密封 ▪ permits fluid communication ≈ 一光源	X										X	X
58	EP0723146A1 (designation of the inventor has not yet been filed The, 1996)	Up-converting reporters for biological and other assays using laser excitation techniques	▪ fluid communication ≈ second electrical signal	X
59	EP0693560A2 (Hugh V. Cottingham, 1996)	Method and apparatus for fully automated nucleic acid amplification, nucleic acid assay and immunoassay	▪ reagent chamber ≈ reagent chamber ▪ open position ≈ open position	X		X					X	X
60	JPH0727700A (Kakin Jiyo, 1995)	光学式成分濃度測定装置および方法	▪ detection assembly ≈ 検出手段, 受光部 ▪ assay reagent ≈ 測定方法	X
61	EP0576602A1 (James E Aysta, 1994)	A device and a method for separating liquid samples.	▪ tight seal ≈ tight seal											X
62	CN1173776C (J・W・帕斯, 2004)	在微规模流体性设备里的高通过量的筛选分析系统	▪ fluid communication ≈ 微流体装置, 体系统 ▪ metering channel ≈ 包括通过 ▪ bodily fluid, bodily fluid sample ≈ 系统一起, 第一横	X			X	X	X			X					X
63	JP2003315348A (Tatsutoshi Imaoka, 2003)	検体処理システム及びそれを用いた検体検査自動化システム	▪ bodily fluid sample ≈ 前記生	X
64	CN1746675A (李人, 2006)	免疫层析测试条及其制造方法	▪ sample collection unit ≈ 的样品				X	X	X
65	JP2005104750A (Hisahide Wakita, 2005)	ナノチューブの精製方法	▪ communication assembly ≈ 少なくとも１, 前記基	X
66	JP2005015243A (Takeo Matsui, 2005)	高純度ナノスケールカーボンチューブ含有炭素質材料の製造法	▪ communication assembly ≈ 少なくとも１ ▪ open position ≈ フレーク ▪ detection assembly ≈ 静電気	X		X
67	EP1360931A1 (Ernest Kiser, 2003)	Physiological sample collection devices and method of using the same	▪ fluid communication ≈ fluid communication	X
68	EP1346686A2 (Allen J. Brenneman, 2003)	Fluid collection apparatus having an integrated lancet and reaction area	▪ fluid communication ≈ fluid communication	X
69	JP2003222611A (Masakazu Baba, 2003)	分離装置、分離方法および分離装置の製造方法	▪ fluid communication ≈ １乃至６ ▪ metering element ≈ 開口部 ▪ sealing element ≈ の流路	X	X							X		X
70	CN1415964A (刘镭, 2003)	糖尿病自身免疫抗体检测蛋白芯片、其制备及检测方法	▪ sealing element, sealing member ≈ 密封包装 ▪ mixing chamber ≈ 上表面					X				X		X	X
71	JP2003057244A (Takehito Ito, 2003)	記録媒体およびこの記録媒体を用いた血糖測定システム	▪ fluid communication ≈ デジタル	X
72	JP2002371955A (Sannosuke Sanuki, 2002)	往復駆動装置及び該装置を使用した送液ポンプ	▪ open position ≈ 前記プランジャ	X		X
73	JP2002266762A (Shozo Funakura, 2002)	冷凍サイクル装置	▪ pressure means ≈ ４０００ ▪ reaction site ≈ 非極性	X			X					X
74	JP2002263185A (Hiroyuki Kuriyama, 2002)	投薬システム及び方法及び投薬装置	▪ pressure means, port engaging pressure means ≈ 投薬機構				X
75	EP1225442A2 (Gary E. Rehm, 2002)	Method and apparatus for using infrared readings to detect misidentification of a diagnostic test strip in a reflectance spectrometer	▪ assay protocol, assay reagent ≈ said test field	X														X
76	JP2002161856A (Hiroyuki Fukuhara, 2002)	シャフトおよびシャフトの製造方法	▪ open position ≈ 前記密閉容器 ▪ reaction site ≈ マルテン	X		X						X
77	JP2002041654A (Cristoph Cronrath, 2002)	契約ベースのバイオセンサーモニターシステムおよびバイオセンサーモニター方法	▪ first location ≈ 前記テスト									X
78	JP2002044007A (Nobuhiro Takeda, 2002)	携帯電話機	▪ detection assembly ≈ 検出信号	X
79	JP2002031055A (Mototaka Ezumi, 2002)	密閉型圧縮機	▪ reaction site ≈ マルテン	X								X
80	EP1174078A2 (Robert C. Whitson, 2002)	Hollow microneedle patch	▪ fluid communication ≈ fluid communication	X
81	JP2002010990A (Arkady Glukhovsky, 2002)	組織の電気的特性の計測	▪ bodily fluid sample ≈ 前記生	X
82	JP2001319560A (Koji Akiyama, 2001)	電子放出素子およびそれを利用した電子源、電界放出型画像表示装置、蛍光灯、並びにそれらの製造方法	▪ communication assembly ≈ 少なくとも１ ▪ dilution chamber ≈ 制御回路と	X			X
83	JP2001165752A (Toshiyuki Ikeda, 2001)	血清量測定装置および測定方法	▪ detection assembly ≈ 検出手段 ▪ assay reagent ≈ 測定方法	X
84	EP1106244A2 (S. Howard Bergh, 2001)	Chemical processing microsystems and controlling reaction conditions in same	▪ fluid communication ≈ fluid communication	X
85	EP1086719A1 (Carl Randolph Bock, 2001)	Method and device for abrading skin	▪ valve assembly ≈ substantially straight line									X
86	JP2001065458A (Shozo Funakura, 2001)	圧縮機	▪ open position ≈ 前記密閉容器	X		X
87	EP0971039A2 (Jack Coleman, 2000)	Processes useful for nucleic acid amplification and sequencing, and for the production of nucleic acid having decreased thermodynamic stability	▪ bodily fluid sample, reaction site, assay reagent, bodily fluid ≈ nucleic acid sequencing	X								X					X
88	JPH11352094A (Makoto Ikeda, 1999)	電気化学分析素子	▪ metering element ≈ 開口部	X	X
89	EP0844475A2 (Michael Anthony Wood, 1998)	Particle sizing apparatus	▪ fluid communication ≈ fluid communication	X
90	JPH10132712A (Yoshihiko Higuchi, 1998)	検体分析用具およびそれを用いた検体分析方法並びに検体分析装置	▪ detection assembly ≈ 検出手段	X
91	JPH1072628A (Harry W Ii Miller, 1998)	エアバッグ用インフレーターの再利用	▪ port engaging pressure means ≈ アッセンブリ ▪ sample collection unit ≈ 金属部品 ▪ fluid communication, permits fluid communication ≈ 該部品	X			X	X	X
92	JPH09192218A (Toshiko Fujii, 1997)	血糖値管理システム	▪ communication assembly ≈ 少なくとも１ ▪ bodily fluid sample ≈ 該液体, 前記生 ▪ reaction site ≈ 操作部	X								X
93	JPH0980021A (Masayoshi Funato, 1997)	マルチキャピラリ電気泳動装置	▪ detection assembly ≈ 光検出	X
94	JPH0968533A (Masaki Yamaguchi, 1997)	薬品投与量を表示可能な生化学物質測定装置	▪ communication assembly ≈ 少なくとも１ ▪ detection assembly ≈ 検出手段 ▪ bodily fluid sample ≈ 前記生	X
95	JPH08334505A (Fritz Bek, 1996)	小型化全分析システム	▪ communication assembly ≈ 少なくとも１, 前記基 ▪ sample collection unit ≈ ２０４	X			X	X	X
96	JPH07196314A (Minoru Hanazaki, 1995)	チューブ状合成無機微粒子	▪ communication assembly ≈ 少なくとも１	X
97	EP0637996A1 (Peter Wilding, 1995)	Microfabricated detection structures.	▪ fluid communication ≈ fluid communication ▪ sealing member ≈ said holding means	X										X	X
98	EP0636685A2 (Leonidas Kolaitis, 1995)	Particulate foam control agents and their use	▪ reaction site ≈ 6 carbon atoms	X								X

US10533994B2 Filed: 2006-03-24     Issued: 2020-01-14 Systems and methods of sample processing and fluid control in a fluidic system (Original Assignee) Theranos IP Co LLC     (Current Assignee) Theranos IP Co LLC Elizabeth A. Holmes, Shaunak Roy, Ian Gibbons, Shize Daniel Qi, Edmond Ku, Chris Todd, Melissa Takahashi, Bruce Johnson, Jeff Fenton, Keith Moravick, Uwe Springborn, Anthony Delacruz

US5842787A Filed: 1997-10-09     Issued: 1998-12-01 Microfluidic systems incorporating varied channel dimensions (Original Assignee) Caliper Technologies Corp     (Current Assignee) Caliper Life Sciences Inc Anne R. Kopf-Sill, John Wallace Parce

US10533994B2 CLAIM 1. A system for detecting the presence or absence of an analyte in a bodily fluid sample obtained from a subject, comprising: a cartridge, comprising: a sample collection unit, comprising: a sample collection well configured to receive a portion of the sample; a metering channel in fluid communication (fluid communication) with the sample collection well and configured such that the sample flows from the sample collection well into the metering channel; and a metering element comprising a mechanically movable portion configured to be movable from an open position that permits fluid communication between the sample collection well and the metering channel to a closed position that does not provide fluid communication between the sample collection well, thereby isolating a specific volume of the sample in the metering channel; a lysing assembly configured to lyse cells present in the sample; and an assay assembly comprising a reaction site containing a reactant able to react with the analyte to yield a detectable signal indicative of the presence or absence of the analyte; and a reader assembly comprising: a detection assembly configured to detect the signal; and a communication assembly configured to receive an assay protocol in response to receiving an identity of the cartridge from an external device, the external device being separate from the reader assembly, the communication assembly further configured to transmit the signal to the external device.

US5842787A CLAIM 3. The microfluidic device of claim 1, further comprising first and second reservoirs disposed in the body structure, the first and second reservoirs being in fluid communication (fluid communication) with the first and second ends of the first microscale channel, respectively.

US10533994B2 Filed: 2006-03-24     Issued: 2020-01-14 Systems and methods of sample processing and fluid control in a fluidic system (Original Assignee) Theranos IP Co LLC     (Current Assignee) Theranos IP Co LLC Elizabeth A. Holmes, Shaunak Roy, Ian Gibbons, Shize Daniel Qi, Edmond Ku, Chris Todd, Melissa Takahashi, Bruce Johnson, Jeff Fenton, Keith Moravick, Uwe Springborn, Anthony Delacruz

US5885470A Filed: 1997-04-14     Issued: 1999-03-23 Controlled fluid transport in microfabricated polymeric substrates (Original Assignee) Caliper Technologies Corp     (Current Assignee) Caliper Life Sciences Inc John Wallace Parce, Michael R. Knapp, Calvin Y. H. Chow, Luc Bousse

US10533994B2 CLAIM 1. A system for detecting the presence or absence of an analyte in a bodily fluid sample obtained from a subject, comprising: a cartridge, comprising: a sample collection unit, comprising: a sample collection well configured to receive a portion of the sample; a metering channel in fluid communication (fluid communication) with the sample collection well and configured such that the sample flows from the sample collection well into the metering channel; and a metering element comprising a mechanically movable portion configured to be movable from an open position that permits fluid communication between the sample collection well and the metering channel to a closed position that does not provide fluid communication between the sample collection well, thereby isolating a specific volume of the sample in the metering channel; a lysing assembly configured to lyse cells present in the sample; and an assay assembly comprising a reaction site containing a reactant able to react with the analyte to yield a detectable signal indicative of the presence or absence of the analyte; and a reader assembly comprising: a detection assembly configured to detect the signal; and a communication assembly configured to receive an assay protocol in response to receiving an identity of the cartridge from an external device, the external device being separate from the reader assembly, the communication assembly further configured to transmit the signal to the external device.

US5885470A CLAIM 16. A method of fabricating a microfluidic device, for use with an electroosmotic fluid direction system, comprising: molding a polymeric material to form a substrate having at least one surface, said at least one surface having at least first and second intersecting channels disposed therein, each of said at least first and second intersecting channels having an interior surface, said interior surface having a zeta potential associated therewith, which zeta potential is capable of supporting an electroosmotic mobility of a fluid in said channels of at least 1×10 -5 cm 2 V -1 s -1 , wherein said fluid is from about 1 mM to about 10 mM sodium borate buffer, at a pH of from about 7 to about 9, at least one of said first and second intersecting channels having at least one cross-sectional dimension in a range of from about 0.1 μm to about 500 μm; and overlaying a cover layer on said at least one surface, said cover layer enclosing said first and second intersecting channels, and wherein said substrate and said cover layer together comprise at least three ports disposed therein, each of said at least three ports being in fluid communication (fluid communication) with first and second termini of said first channel and at least one terminus of said second channel.

US10533994B2 Filed: 2006-03-24     Issued: 2020-01-14 Systems and methods of sample processing and fluid control in a fluidic system (Original Assignee) Theranos IP Co LLC     (Current Assignee) Theranos IP Co LLC Elizabeth A. Holmes, Shaunak Roy, Ian Gibbons, Shize Daniel Qi, Edmond Ku, Chris Todd, Melissa Takahashi, Bruce Johnson, Jeff Fenton, Keith Moravick, Uwe Springborn, Anthony Delacruz

US5876675A Filed: 1997-08-05     Issued: 1999-03-02 Microfluidic devices and systems (Original Assignee) Caliper Technologies Corp     (Current Assignee) Caliper Life Sciences Inc Colin B. Kennedy

US10533994B2 CLAIM 1. A system for detecting the presence or absence of an analyte in a bodily fluid sample obtained from a subject, comprising: a cartridge, comprising: a sample collection unit, comprising: a sample collection well configured to receive a portion of the sample; a metering channel in fluid communication (fluid communication) with the sample collection well and configured such that the sample flows from the sample collection well into the metering channel; and a metering element comprising a mechanically movable portion configured to be movable from an open position that permits fluid communication between the sample collection well and the metering channel to a closed position that does not provide fluid communication between the sample collection well, thereby isolating a specific volume of the sample in the metering channel; a lysing assembly configured to lyse cells present in the sample; and an assay assembly comprising a reaction site containing a reactant able to react with the analyte to yield a detectable signal indicative of the presence or absence of the analyte; and a reader assembly comprising: a detection assembly configured to detect the signal; and a communication assembly configured to receive an assay protocol in response to receiving an identity of the cartridge from an external device, the external device being separate from the reader assembly, the communication assembly further configured to transmit the signal to the external device.

US5876675A CLAIM 2. The microfluidic apparatus of claim 1, wherein the first surface of the microfluidic device comprises a plurality of wells disposed therein, wherein said wells are in fluid communication (fluid communication) with at least one of said at least two intersecting channels.

US10533994B2 Filed: 2006-03-24     Issued: 2020-01-14 Systems and methods of sample processing and fluid control in a fluidic system (Original Assignee) Theranos IP Co LLC     (Current Assignee) Theranos IP Co LLC Elizabeth A. Holmes, Shaunak Roy, Ian Gibbons, Shize Daniel Qi, Edmond Ku, Chris Todd, Melissa Takahashi, Bruce Johnson, Jeff Fenton, Keith Moravick, Uwe Springborn, Anthony Delacruz	US6046056A Filed: 1996-12-06     Issued: 2000-04-04 High throughput screening assay systems in microscale fluidic devices (Original Assignee) Caliper Technologies Corp     (Current Assignee) Caliper Life Sciences Inc J. Wallace Parce, Anne R. Kopf-Sill, Luc J. Bousse
US10533994B2 CLAIM 1. A system for detecting the presence or absence of an analyte in a bodily fluid sample obtained from a subject, comprising: a cartridge, comprising: a sample collection unit, comprising: a sample collection well configured to receive a portion of the sample; a metering channel (said second component) in fluid communication with the sample collection well and configured such that the sample flows from the sample collection well into the metering channel; and a metering element (said second component) comprising a mechanically movable portion configured to be movable from an open position that permits fluid communication between the sample collection well and the metering channel to a closed position that does not provide fluid communication between the sample collection well, thereby isolating a specific volume of the sample in the metering channel; a lysing assembly configured to lyse cells present in the sample; and an assay assembly comprising a reaction site containing a reactant able to react with the analyte to yield a detectable signal indicative of the presence or absence of the analyte; and a reader assembly comprising: a detection assembly configured to detect the signal; and a communication assembly configured to receive an assay protocol in response to receiving an identity of the cartridge from an external device, the external device being separate from the reader assembly, the communication assembly further configured to transmit the signal to the external device.	US6046056A CLAIM 3. The apparatus of claim 1, further comprising a source of a second component of said biochemical system, and a third channel fabricated into said surface, said third channel fluidly connecting at least one of said at least two intersecting channels with said source of said second component (metering channel, metering element, sealing element) of said biochemical system.
US10533994B2 CLAIM 2. The system of claim 1 , wherein the metering element (said second component) comprises a pin.	US6046056A CLAIM 3. The apparatus of claim 1, further comprising a source of a second component of said biochemical system, and a third channel fabricated into said surface, said third channel fluidly connecting at least one of said at least two intersecting channels with said source of said second component (metering channel, metering element, sealing element) of said biochemical system.
US10533994B2 CLAIM 10. The system of claim 1 , wherein the reaction site of the assay assembly is in fluidic communication with the sample collection unit, the reaction site containing a reactant that reacts with the analyte to yield a signal indicative of the presence of the analyte; and the assay assembly further comprises: a reagent chamber in fluidic communication with the reaction site, wherein the reagent chamber is configured to store an assay reagent; a fluidic channel connecting the reagent chamber with the reaction site; and an actuatable valve assembly configured to control the flow of reagent through the fluidic channel, wherein the valve assembly comprises a sealing element (said second component) and actuator element, wherein the channel comprises first and second locations, wherein the sealing element positioned in the first location obstructs the flow of fluid through the channel and the sealing element positioned in the second location allows the flow of fluid through the channel, and wherein the actuator element is adapted to move the sealing element from the first location to the second location.	US6046056A CLAIM 3. The apparatus of claim 1, further comprising a source of a second component of said biochemical system, and a third channel fabricated into said surface, said third channel fluidly connecting at least one of said at least two intersecting channels with said source of said second component (metering channel, metering element, sealing element) of said biochemical system.
US10533994B2 CLAIM 14. The system of claim 10 , wherein the actuator element comprises a sealing member (fluid control system) such that when the actuator element moves the sealing element (said second component) the sealing member forms a substantially air tight seal such that the fluid can only flow through the channel.	US6046056A CLAIM 3. The apparatus of claim 1, further comprising a source of a second component of said biochemical system, and a third channel fabricated into said surface, said third channel fluidly connecting at least one of said at least two intersecting channels with said source of said second component (metering channel, metering element, sealing element) of said biochemical system. US6046056A CLAIM 19. The apparatus of claim 18, wherein said fluid control system (sealing member) comprises: a plurality of individual electrodes, each in electrical contact with each terminus of said at least two transverse channels; and a control system for concomitantly applying a variable voltage at each of said electrodes, whereby movement of said test compounds or said at least first component in said at least two transverse channels and said plurality of reaction channels may be controlled.
US10533994B2 CLAIM 15. The system of claim 14 wherein the actuator element is substantially pin shaped and the sealing member (fluid control system) is an O-ring adapted to be placed around the actuator element.	US6046056A CLAIM 19. The apparatus of claim 18, wherein said fluid control system (sealing member) comprises: a plurality of individual electrodes, each in electrical contact with each terminus of said at least two transverse channels; and a control system for concomitantly applying a variable voltage at each of said electrodes, whereby movement of said test compounds or said at least first component in said at least two transverse channels and said plurality of reaction channels may be controlled.

US10533994B2 Filed: 2006-03-24     Issued: 2020-01-14 Systems and methods of sample processing and fluid control in a fluidic system (Original Assignee) Theranos IP Co LLC     (Current Assignee) Theranos IP Co LLC Elizabeth A. Holmes, Shaunak Roy, Ian Gibbons, Shize Daniel Qi, Edmond Ku, Chris Todd, Melissa Takahashi, Bruce Johnson, Jeff Fenton, Keith Moravick, Uwe Springborn, Anthony Delacruz	US6440725B1 Filed: 1999-06-25     Issued: 2002-08-27 Integrated fluid manipulation cartridge (Original Assignee) Cepheid Inc     (Current Assignee) Cepheid Inc Farzad Pourahmadi, William A. McMillan, Jesus Ching, Ronald Chang, Lee A. Christel, Gregory T. A. Kovacs, M. Allen Northrup, Kurt E. Petersen
US10533994B2 CLAIM 1. A system for detecting the presence or absence of an analyte in a bodily fluid sample obtained from a subject, comprising: a cartridge, comprising: a sample collection unit, comprising: a sample collection well configured to receive a portion of the sample; a metering channel in fluid communication (fluid communication) with the sample collection well and configured such that the sample flows from the sample collection well into the metering channel; and a metering element comprising a mechanically movable portion configured to be movable from an open position that permits fluid communication between the sample collection well and the metering channel to a closed position that does not provide fluid communication between the sample collection well, thereby isolating a specific volume of the sample in the metering channel; a lysing assembly configured to lyse cells present in the sample; and an assay assembly comprising a reaction site containing a reactant able to react with the analyte to yield a detectable signal indicative of the presence or absence of the analyte; and a reader assembly comprising: a detection assembly configured to detect the signal; and a communication assembly configured to receive an assay protocol in response to receiving an identity of the cartridge from an external device, the external device being separate from the reader assembly, the communication assembly further configured to transmit the signal to the external device.	US6440725B1 CLAIM 4. The device of claim 1 , wherein the cartridge further includes a reagent chamber in fluid communication (fluid communication) with the lysing chamber for holding a lysing reagent.
US10533994B2 CLAIM 9. The system of claim 8 , wherein the assay assembly comprises a reagent chamber (reagent chamber) in fluidic communication with the reaction site, wherein the reagent chamber is configured to store an assay reagent.	US6440725B1 CLAIM 4. The device of claim 1 , wherein the cartridge further includes a reagent chamber (reagent chamber) in fluid communication with the lysing chamber for holding a lysing reagent.
US10533994B2 CLAIM 10. The system of claim 1 , wherein the reaction site of the assay assembly is in fluidic communication with the sample collection unit, the reaction site containing a reactant that reacts with the analyte to yield a signal indicative of the presence of the analyte; and the assay assembly further comprises: a reagent chamber (reagent chamber) in fluidic communication with the reaction site, wherein the reagent chamber is configured to store an assay reagent; a fluidic channel connecting the reagent chamber with the reaction site; and an actuatable valve assembly configured to control the flow of reagent through the fluidic channel, wherein the valve assembly comprises a sealing element and actuator element, wherein the channel comprises first and second locations, wherein the sealing element positioned in the first location obstructs the flow of fluid through the channel and the sealing element positioned in the second location allows the flow of fluid through the channel, and wherein the actuator element is adapted to move the sealing element from the first location to the second location.	US6440725B1 CLAIM 4. The device of claim 1 , wherein the cartridge further includes a reagent chamber (reagent chamber) in fluid communication with the lysing chamber for holding a lysing reagent.

US10533994B2 Filed: 2006-03-24     Issued: 2020-01-14 Systems and methods of sample processing and fluid control in a fluidic system (Original Assignee) Theranos IP Co LLC     (Current Assignee) Theranos IP Co LLC Elizabeth A. Holmes, Shaunak Roy, Ian Gibbons, Shize Daniel Qi, Edmond Ku, Chris Todd, Melissa Takahashi, Bruce Johnson, Jeff Fenton, Keith Moravick, Uwe Springborn, Anthony Delacruz	US6174675B1 Filed: 1998-08-27     Issued: 2001-01-16 Electrical current for controlling fluid parameters in microchannels (Original Assignee) Caliper Technologies Corp     (Current Assignee) Caliper Life Sciences Inc Calvin Y. H. Chow, Anne R. Kopf-Sill, John Wallace Parce
US10533994B2 CLAIM 4. The system of claim 2 , wherein the sample collection unit further comprises: a dilution chamber in fluidic communication with the metering channel, wherein the dilution chamber is configured to store a diluent and comprises a port engaging pressure means (cross sectional area) transferring the diluent from the dilution chamber into the metering channel.	US6174675B1 CLAIM 2. The system of claim 1 , wherein the first portion of the first channel comprises a cross-sectional area smaller than a cross sectional area (port engaging pressure means) of second portion of the first channel.

US10533994B2 Filed: 2006-03-24     Issued: 2020-01-14 Systems and methods of sample processing and fluid control in a fluidic system (Original Assignee) Theranos IP Co LLC     (Current Assignee) Theranos IP Co LLC Elizabeth A. Holmes, Shaunak Roy, Ian Gibbons, Shize Daniel Qi, Edmond Ku, Chris Todd, Melissa Takahashi, Bruce Johnson, Jeff Fenton, Keith Moravick, Uwe Springborn, Anthony Delacruz

US20030212379A1 Filed: 2003-02-20     Issued: 2003-11-13 Systems and methods for remotely controlling medication infusion and analyte monitoring (Original Assignee) LifeScan Inc     (Current Assignee) LifeScan Inc Adam Bylund, William Durban, Michael Wardle, Karen Long, Joseph McCluskey, Ulrich Kraft, Manfred Ebner, Matthias Stiene

US10533994B2 CLAIM 1. A system for detecting the presence or absence of an analyte in a bodily fluid sample obtained from a subject, comprising: a cartridge, comprising: a sample collection unit, comprising: a sample collection well configured to receive a portion of the sample; a metering channel in fluid communication (fluid communication) with the sample collection well and configured such that the sample flows from the sample collection well into the metering channel; and a metering element comprising a mechanically movable portion configured to be movable from an open position that permits fluid communication between the sample collection well and the metering channel to a closed position that does not provide fluid communication between the sample collection well, thereby isolating a specific volume of the sample in the metering channel; a lysing assembly configured to lyse cells present in the sample; and an assay assembly comprising a reaction site containing a reactant able to react with the analyte to yield a detectable signal indicative of the presence or absence of the analyte; and a reader assembly comprising: a detection assembly configured to detect the signal; and a communication assembly configured to receive an assay protocol in response to receiving an identity of the cartridge from an external device, the external device being separate from the reader assembly, the communication assembly further configured to transmit the signal to the external device.

US20030212379A1 CLAIM 17 . The system of claim 1 wherein said physiological fluid monitoring device comprises: a physiological fluid sampling means; and a sensor for measuring the concentration of one or more analytes within physiological fluid, wherein said sensor is operatively connected and in fluid communication (fluid communication) with said physiological fluid sampling means.

US10533994B2 Filed: 2006-03-24     Issued: 2020-01-14 Systems and methods of sample processing and fluid control in a fluidic system (Original Assignee) Theranos IP Co LLC     (Current Assignee) Theranos IP Co LLC Elizabeth A. Holmes, Shaunak Roy, Ian Gibbons, Shize Daniel Qi, Edmond Ku, Chris Todd, Melissa Takahashi, Bruce Johnson, Jeff Fenton, Keith Moravick, Uwe Springborn, Anthony Delacruz	US20050054078A1 Filed: 2003-09-10     Issued: 2005-03-10 Immunoassay device with improved sample closure (Original Assignee) iStat Corp     (Current Assignee) Abbott Point of Care Inc Cary Miller, Andy Maczuszenko
US10533994B2 CLAIM 1. A system for detecting the presence or absence of an analyte in a bodily fluid (sample collection device) sample (sample collection device) obtained from a subject, comprising: a cartridge, comprising: a sample collection unit, comprising: a sample collection well configured to receive a portion of the sample; a metering channel in fluid communication (fluid communication) with the sample collection well and configured such that the sample flows from the sample collection well into the metering channel; and a metering element comprising a mechanically movable portion configured to be movable from an open position that permits fluid communication between the sample collection well and the metering channel to a closed position that does not provide fluid communication between the sample collection well, thereby isolating a specific volume of the sample in the metering channel; a lysing assembly configured to lyse cells present in the sample; and an assay assembly comprising a reaction site containing a reactant able to react with the analyte to yield a detectable signal indicative of the presence or absence of the analyte; and a reader assembly comprising: a detection assembly configured to detect the signal; and a communication assembly configured to receive an assay protocol in response to receiving an identity of the cartridge from an external device, the external device being separate from the reader assembly, the communication assembly further configured to transmit the signal to the external device.	US20050054078A1 CLAIM 1 . A method of sealing a fluid sample collection device (bodily fluid sample, bodily fluid) , comprising: loading a fluid sample collection device with a fluid sample, said device comprising a housing having at least one substantially planar surface that includes an orifice in fluid communication (fluid communication) with an internal fluid sample holding chamber which terminates at an internal capillary stop; and slidably moving a sealing element over at least a portion of said substantially planar surface in a way that displaces any excess fluid sample away from the orifice, seals the fluid sample within said holding chamber, and inhibits the fluid sample from prematurely breaking through the internal capillary stop.
US10533994B2 CLAIM 14. The system of claim 10 , wherein the actuator element comprises a sealing member such that when the actuator element moves the sealing element the sealing member forms a substantially air tight seal (tight seal) such that the fluid can only flow through the channel.
US10533994B2 CLAIM 17. The system of claim 10 , wherein the sample of bodily fluid (sample collection device) is less than 50 μl.	US20050054078A1 CLAIM 1 . A method of sealing a fluid sample collection device (bodily fluid sample, bodily fluid) , comprising: loading a fluid sample collection device with a fluid sample, said device comprising a housing having at least one substantially planar surface that includes an orifice in fluid communication with an internal fluid sample holding chamber which terminates at an internal capillary stop; and slidably moving a sealing element over at least a portion of said substantially planar surface in a way that displaces any excess fluid sample away from the orifice, seals the fluid sample within said holding chamber, and inhibits the fluid sample from prematurely breaking through the internal capillary stop.

US10533994B2 Filed: 2006-03-24     Issued: 2020-01-14 Systems and methods of sample processing and fluid control in a fluidic system (Original Assignee) Theranos IP Co LLC     (Current Assignee) Theranos IP Co LLC Elizabeth A. Holmes, Shaunak Roy, Ian Gibbons, Shize Daniel Qi, Edmond Ku, Chris Todd, Melissa Takahashi, Bruce Johnson, Jeff Fenton, Keith Moravick, Uwe Springborn, Anthony Delacruz	US6491666B1 Filed: 2000-11-17     Issued: 2002-12-10 Microfabricated devices for the delivery of molecules into a carrier fluid (Original Assignee) MicroChips Inc     (Current Assignee) Boston Scientific Scimed Inc John T. Santini, Jr., Charles E. Hutchinson, Scott A. Uhland, Michael J. Cima, Robert S. Langer, Dennis Ausiello
US10533994B2 CLAIM 1. A system for detecting the presence or absence of an analyte in a bodily fluid sample obtained from a subject, comprising: a cartridge, comprising: a sample collection unit, comprising: a sample collection well configured to receive a portion of the sample; a metering channel in fluid communication (fluid communication) with the sample collection well and configured such that the sample flows from the sample collection well into the metering channel; and a metering element comprising a mechanically movable portion configured to be movable from an open position that permits fluid communication between the sample collection well and the metering channel to a closed position that does not provide fluid communication between the sample collection well, thereby isolating a specific volume of the sample in the metering channel; a lysing assembly configured to lyse cells present in the sample; and an assay assembly comprising a reaction site containing a reactant able to react with the analyte to yield a detectable signal indicative of the presence or absence of the analyte; and a reader assembly comprising: a detection assembly configured to detect the signal; and a communication assembly configured to receive an assay protocol in response to receiving an identity of the cartridge from an external device, the external device being separate from the reader assembly, the communication assembly further configured to transmit the signal to the external device.	US6491666B1 CLAIM 2. The apparatus of claim 1 further comprising a mixing chamber in fluid communication (fluid communication) with the container, wherein the molecules are combined with the carrier fluid in the mixing chamber.
US10533994B2 CLAIM 5. The system of claim 4 , wherein the sample collection unit further comprises a mixing chamber (mixing chamber) in fluidic communication with the metering channel, the mixing chamber being configured to mix the predetermined portion of the sample with the diluent to yield a diluted sample.	US6491666B1 CLAIM 2. The apparatus of claim 1 further comprising a mixing chamber (mixing chamber) in fluid communication with the container, wherein the molecules are combined with the carrier fluid in the mixing chamber.

US10533994B2 Filed: 2006-03-24     Issued: 2020-01-14 Systems and methods of sample processing and fluid control in a fluidic system (Original Assignee) Theranos IP Co LLC     (Current Assignee) Theranos IP Co LLC Elizabeth A. Holmes, Shaunak Roy, Ian Gibbons, Shize Daniel Qi, Edmond Ku, Chris Todd, Melissa Takahashi, Bruce Johnson, Jeff Fenton, Keith Moravick, Uwe Springborn, Anthony Delacruz	US20040005582A1 Filed: 2002-12-19     Issued: 2004-01-08 Biospecific desorption microflow systems and methods for studying biospecific interactions and their modulators (Original Assignee) NanoBioDynamics Inc     (Current Assignee) NanoBioDynamics Inc Edward Shipwash
US10533994B2 CLAIM 1. A system for detecting the presence or absence of an analyte in a bodily fluid sample obtained from a subject, comprising: a cartridge, comprising: a sample collection unit, comprising: a sample collection well configured to receive a portion of the sample; a metering channel in fluid communication with the sample collection well and configured such that the sample flows from the sample collection well into the metering channel; and a metering element comprising a mechanically movable portion configured to be movable from an open position that permits fluid communication between the sample collection well and the metering channel to a closed position that does not provide fluid communication between the sample collection well, thereby isolating a specific volume of the sample in the metering channel; a lysing assembly configured to lyse cells present in the sample; and an assay assembly (amino acid sequence) comprising a reaction site containing a reactant able to react with the analyte to yield a detectable signal indicative of the presence or absence of the analyte; and a reader assembly comprising: a detection assembly configured to detect the signal; and a communication assembly configured to receive an assay protocol in response to receiving an identity of the cartridge from an external device, the external device being separate from the reader assembly, the communication assembly further configured to transmit the signal to the external device.	US20040005582A1 CLAIM 1 . A microfluidic biospecific desorption assay method for characterizing the binding site of a protein, said method comprising: (1) establishing a buffer flow through a microchannel in fluidic contact with an immobilized binding complex comprising a first immobilized binding pair member and a second labeled binding pair member; wherein one of the first or second members is the protein or a fragment of the protein; and wherein the protein or protein fragment is bound to the other binding pair member via the binding site; (2) introducing a polypeptide into the buffer flow; wherein the polypeptide has an amino acid subsequence of the protein; (3) detecting the desorption of the label following introduction of the polypeptide; and repeating steps (2) and (3) for each of a plurality of polypeptides of differing amino acid sequence (assay assembly, sealing element) s, wherein at least one of the polypeptides comprises the binding site; whereby the polypeptide comprising the binding site is identified and the binding site is thereby localized to a portion of the protein having the amino acid sequence of the polypeptide comprising the binding site.
US10533994B2 CLAIM 8. The system of claim 1 , wherein the assay assembly (amino acid sequence) is adapted to run an immunoassay.	US20040005582A1 CLAIM 1 . A microfluidic biospecific desorption assay method for characterizing the binding site of a protein, said method comprising: (1) establishing a buffer flow through a microchannel in fluidic contact with an immobilized binding complex comprising a first immobilized binding pair member and a second labeled binding pair member; wherein one of the first or second members is the protein or a fragment of the protein; and wherein the protein or protein fragment is bound to the other binding pair member via the binding site; (2) introducing a polypeptide into the buffer flow; wherein the polypeptide has an amino acid subsequence of the protein; (3) detecting the desorption of the label following introduction of the polypeptide; and repeating steps (2) and (3) for each of a plurality of polypeptides of differing amino acid sequence (assay assembly, sealing element) s, wherein at least one of the polypeptides comprises the binding site; whereby the polypeptide comprising the binding site is identified and the binding site is thereby localized to a portion of the protein having the amino acid sequence of the polypeptide comprising the binding site.
US10533994B2 CLAIM 9. The system of claim 8 , wherein the assay assembly (amino acid sequence) comprises a reagent chamber in fluidic communication with the reaction site, wherein the reagent chamber is configured to store an assay reagent.	US20040005582A1 CLAIM 1 . A microfluidic biospecific desorption assay method for characterizing the binding site of a protein, said method comprising: (1) establishing a buffer flow through a microchannel in fluidic contact with an immobilized binding complex comprising a first immobilized binding pair member and a second labeled binding pair member; wherein one of the first or second members is the protein or a fragment of the protein; and wherein the protein or protein fragment is bound to the other binding pair member via the binding site; (2) introducing a polypeptide into the buffer flow; wherein the polypeptide has an amino acid subsequence of the protein; (3) detecting the desorption of the label following introduction of the polypeptide; and repeating steps (2) and (3) for each of a plurality of polypeptides of differing amino acid sequence (assay assembly, sealing element) s, wherein at least one of the polypeptides comprises the binding site; whereby the polypeptide comprising the binding site is identified and the binding site is thereby localized to a portion of the protein having the amino acid sequence of the polypeptide comprising the binding site.
US10533994B2 CLAIM 10. The system of claim 1 , wherein the reaction site of the assay assembly (amino acid sequence) is in fluidic communication with the sample collection unit, the reaction site containing a reactant that reacts with the analyte to yield a signal indicative of the presence of the analyte; and the assay assembly further comprises: a reagent chamber in fluidic communication with the reaction site, wherein the reagent chamber is configured to store an assay reagent; a fluidic channel connecting the reagent chamber with the reaction site; and an actuatable valve assembly configured to control the flow of reagent through the fluidic channel, wherein the valve assembly comprises a sealing element (amino acid sequence) and actuator element, wherein the channel comprises first and second locations, wherein the sealing element positioned in the first location obstructs the flow of fluid through the channel and the sealing element positioned in the second location allows the flow of fluid through the channel, and wherein the actuator element is adapted to move the sealing element from the first location to the second location.	US20040005582A1 CLAIM 1 . A microfluidic biospecific desorption assay method for characterizing the binding site of a protein, said method comprising: (1) establishing a buffer flow through a microchannel in fluidic contact with an immobilized binding complex comprising a first immobilized binding pair member and a second labeled binding pair member; wherein one of the first or second members is the protein or a fragment of the protein; and wherein the protein or protein fragment is bound to the other binding pair member via the binding site; (2) introducing a polypeptide into the buffer flow; wherein the polypeptide has an amino acid subsequence of the protein; (3) detecting the desorption of the label following introduction of the polypeptide; and repeating steps (2) and (3) for each of a plurality of polypeptides of differing amino acid sequence (assay assembly, sealing element) s, wherein at least one of the polypeptides comprises the binding site; whereby the polypeptide comprising the binding site is identified and the binding site is thereby localized to a portion of the protein having the amino acid sequence of the polypeptide comprising the binding site.
US10533994B2 CLAIM 14. The system of claim 10 , wherein the actuator element comprises a sealing member such that when the actuator element moves the sealing element (amino acid sequence) the sealing member forms a substantially air tight seal such that the fluid can only flow through the channel.	US20040005582A1 CLAIM 1 . A microfluidic biospecific desorption assay method for characterizing the binding site of a protein, said method comprising: (1) establishing a buffer flow through a microchannel in fluidic contact with an immobilized binding complex comprising a first immobilized binding pair member and a second labeled binding pair member; wherein one of the first or second members is the protein or a fragment of the protein; and wherein the protein or protein fragment is bound to the other binding pair member via the binding site; (2) introducing a polypeptide into the buffer flow; wherein the polypeptide has an amino acid subsequence of the protein; (3) detecting the desorption of the label following introduction of the polypeptide; and repeating steps (2) and (3) for each of a plurality of polypeptides of differing amino acid sequence (assay assembly, sealing element) s, wherein at least one of the polypeptides comprises the binding site; whereby the polypeptide comprising the binding site is identified and the binding site is thereby localized to a portion of the protein having the amino acid sequence of the polypeptide comprising the binding site.
US10533994B2 CLAIM 16. The fluidic device of claim 10 , wherein the assay assembly (amino acid sequence) is adapted to run an immunoassay.	US20040005582A1 CLAIM 1 . A microfluidic biospecific desorption assay method for characterizing the binding site of a protein, said method comprising: (1) establishing a buffer flow through a microchannel in fluidic contact with an immobilized binding complex comprising a first immobilized binding pair member and a second labeled binding pair member; wherein one of the first or second members is the protein or a fragment of the protein; and wherein the protein or protein fragment is bound to the other binding pair member via the binding site; (2) introducing a polypeptide into the buffer flow; wherein the polypeptide has an amino acid subsequence of the protein; (3) detecting the desorption of the label following introduction of the polypeptide; and repeating steps (2) and (3) for each of a plurality of polypeptides of differing amino acid sequence (assay assembly, sealing element) s, wherein at least one of the polypeptides comprises the binding site; whereby the polypeptide comprising the binding site is identified and the binding site is thereby localized to a portion of the protein having the amino acid sequence of the polypeptide comprising the binding site.

US10533994B2 Filed: 2006-03-24     Issued: 2020-01-14 Systems and methods of sample processing and fluid control in a fluidic system (Original Assignee) Theranos IP Co LLC     (Current Assignee) Theranos IP Co LLC Elizabeth A. Holmes, Shaunak Roy, Ian Gibbons, Shize Daniel Qi, Edmond Ku, Chris Todd, Melissa Takahashi, Bruce Johnson, Jeff Fenton, Keith Moravick, Uwe Springborn, Anthony Delacruz	US6591124B2 Filed: 2001-05-11     Issued: 2003-07-08 Portable interstitial fluid monitoring system (Original Assignee) Procter and Gamble Co     (Current Assignee) Corium Inc Faiz Feisal Sherman, Francisco Arias, Vladimir Gartstein, Grover David Owens, Milan Marcel Jevtitch, Chow Chi Huang
US10533994B2 CLAIM 1. A system for detecting the presence or absence of an analyte in a bodily fluid sample obtained from a subject, comprising: a cartridge, comprising: a sample collection unit, comprising: a sample collection well configured to receive a portion of the sample; a metering channel in fluid communication with the sample collection well and configured such that the sample flows from the sample collection well into the metering channel; and a metering element (electrical energy source) comprising a mechanically movable portion configured to be movable from an open position (said second side, said first side) that permits fluid communication between the sample collection well and the metering channel to a closed position that does not provide fluid communication between the sample collection well, thereby isolating a specific volume of the sample in the metering channel; a lysing assembly configured to lyse cells present in the sample; and an assay assembly comprising a reaction site containing a reactant able to react with the analyte to yield a detectable signal indicative of the presence or absence of the analyte; and a reader assembly comprising: a detection assembly configured to detect the signal; and a communication assembly (said main body) configured to receive an assay protocol in response to receiving an identity of the cartridge from an external device, the external device being separate from the reader assembly, the communication assembly further configured to transmit the signal to the external device.	US6591124B2 CLAIM 2. A fluid sampling apparatus, comprising: (a) a plurality of microneedles accessible on a first surface of said fluid sampling apparatus; (b) a manually-operated pumping apparatus accessible on a second surface of said fluid sampling apparatus; and (c) a reservoir that is in hydraulic communication with both said plurality of microneedles and said pumping apparatus; wherein said reservoir receives fluid that flows through said plurality of microneedles upon manual actuation of said pumping apparatus, wherein said first surface is located on a first side of said fluid sampling apparatus, and said second surface is located on a second side of said fluid sampling apparatus, in which said first side (open position, pressure means) is opposite from said second side (open position, pressure means) , wherein said fluid sampling apparatus further comprises (a) a member having a first end proximal to said reservoir and extending to a second end distal from said reservoir, (b) at least one electrode positioned on said extending member, and (c) a sensor pad that is in hydraulic communication with said reservoir; and wherein said at least one electrode is in communication with said sensor pad, and wherein said fluid sampling apparatus further comprises an electrical interface that converts an output of said sensor pad into an electrical signal; a processing circuit that detects a value of said electrical signal and generates an output signal; and a display device that indicates a value representative of said output signal. US6591124B2 CLAIM 8. A fluid sampling apparatus, comprising: (a) an attachable/detachable portion that includes a plurality of microneedles, a reservoir, an optical sensor pad, and an optical window; and (b) a main body portion that includes a receptacle to receive said attachable/detachable portion such that, when in position, the optical window faces said main body (communication assembly) portion and the plurality of microneedles are accessible; a light source and light detector; and a manually-operated control actuator mounted on a surface of said main body portion that causes fluid to flow proximal to said plurality of microneedles; wherein said reservoir receives fluid that flows through said plurality of microneedles upon manual operation of said control actuator, and said optical sensor pad exhibits a change in a physical property that is detected by said light detector as said light source shines light upon said optical sensor pad. US6591124B2 CLAIM 25. A single-use microneedle system, comprising: an array of microneedle members that protrude from a base member, said microneedle members being of a size, shape, and material so as to penetrate through a stratum corneum of skin when placed against said skin; and a self-destruct mechanism that renders said microneedle members incapable of penetrating said stratum corneum after being operative upon said microneedle members, said self-destruct mechanism comprising one of: (a) a heat source, (b) an electrical energy source (metering element) , (c) a optical energy source, (d) a chemical reaction, (e) a mechanical member that exerts a force, or (f) a material that permanently encapsulates the microneedle members.
US10533994B2 CLAIM 2. The system of claim 1 , wherein the metering element (electrical energy source) comprises a pin.	US6591124B2 CLAIM 25. A single-use microneedle system, comprising: an array of microneedle members that protrude from a base member, said microneedle members being of a size, shape, and material so as to penetrate through a stratum corneum of skin when placed against said skin; and a self-destruct mechanism that renders said microneedle members incapable of penetrating said stratum corneum after being operative upon said microneedle members, said self-destruct mechanism comprising one of: (a) a heat source, (b) an electrical energy source (metering element) , (c) a optical energy source, (d) a chemical reaction, (e) a mechanical member that exerts a force, or (f) a material that permanently encapsulates the microneedle members.
US10533994B2 CLAIM 3. The system of claim 2 , wherein the pin is configured to be movable from an open position (said second side, said first side) to a closed position, wherein the pin in the closed position blocks the metering channel.	US6591124B2 CLAIM 2. A fluid sampling apparatus, comprising: (a) a plurality of microneedles accessible on a first surface of said fluid sampling apparatus; (b) a manually-operated pumping apparatus accessible on a second surface of said fluid sampling apparatus; and (c) a reservoir that is in hydraulic communication with both said plurality of microneedles and said pumping apparatus; wherein said reservoir receives fluid that flows through said plurality of microneedles upon manual actuation of said pumping apparatus, wherein said first surface is located on a first side of said fluid sampling apparatus, and said second surface is located on a second side of said fluid sampling apparatus, in which said first side (open position, pressure means) is opposite from said second side (open position, pressure means) , wherein said fluid sampling apparatus further comprises (a) a member having a first end proximal to said reservoir and extending to a second end distal from said reservoir, (b) at least one electrode positioned on said extending member, and (c) a sensor pad that is in hydraulic communication with said reservoir; and wherein said at least one electrode is in communication with said sensor pad, and wherein said fluid sampling apparatus further comprises an electrical interface that converts an output of said sensor pad into an electrical signal; a processing circuit that detects a value of said electrical signal and generates an output signal; and a display device that indicates a value representative of said output signal.
US10533994B2 CLAIM 4. The system of claim 2 , wherein the sample collection unit further comprises: a dilution chamber in fluidic communication with the metering channel, wherein the dilution chamber is configured to store a diluent and comprises a port engaging pressure means (said second side, said first side) transferring the diluent from the dilution chamber into the metering channel.	US6591124B2 CLAIM 2. A fluid sampling apparatus, comprising: (a) a plurality of microneedles accessible on a first surface of said fluid sampling apparatus; (b) a manually-operated pumping apparatus accessible on a second surface of said fluid sampling apparatus; and (c) a reservoir that is in hydraulic communication with both said plurality of microneedles and said pumping apparatus; wherein said reservoir receives fluid that flows through said plurality of microneedles upon manual actuation of said pumping apparatus, wherein said first surface is located on a first side of said fluid sampling apparatus, and said second surface is located on a second side of said fluid sampling apparatus, in which said first side (open position, pressure means) is opposite from said second side (open position, pressure means) , wherein said fluid sampling apparatus further comprises (a) a member having a first end proximal to said reservoir and extending to a second end distal from said reservoir, (b) at least one electrode positioned on said extending member, and (c) a sensor pad that is in hydraulic communication with said reservoir; and wherein said at least one electrode is in communication with said sensor pad, and wherein said fluid sampling apparatus further comprises an electrical interface that converts an output of said sensor pad into an electrical signal; a processing circuit that detects a value of said electrical signal and generates an output signal; and a display device that indicates a value representative of said output signal.

US10533994B2 Filed: 2006-03-24     Issued: 2020-01-14 Systems and methods of sample processing and fluid control in a fluidic system (Original Assignee) Theranos IP Co LLC     (Current Assignee) Theranos IP Co LLC Elizabeth A. Holmes, Shaunak Roy, Ian Gibbons, Shize Daniel Qi, Edmond Ku, Chris Todd, Melissa Takahashi, Bruce Johnson, Jeff Fenton, Keith Moravick, Uwe Springborn, Anthony Delacruz

US5939291A Filed: 1996-06-14     Issued: 1999-08-17 Microfluidic method for nucleic acid amplification (Original Assignee) Sarnoff Corp     (Current Assignee) Sarnoff Corp Zvi Loewy, Rajan Kumar

US10533994B2 CLAIM 1. A system for detecting the presence or absence of an analyte in a bodily fluid sample obtained from a subject, comprising: a cartridge, comprising: a sample collection unit, comprising: a sample collection well configured to receive a portion of the sample; a metering channel in fluid communication with the sample collection well and configured such that the sample flows from the sample collection well into the metering channel; and a metering element comprising a mechanically movable portion configured to be movable from an open position that permits fluid communication between the sample collection well and the metering channel to a closed position that does not provide fluid communication between the sample collection well, thereby isolating a specific volume of the sample in the metering channel; a lysing assembly configured to lyse cells present in the sample; and an assay assembly comprising a reaction site containing a reactant able to react with the analyte to yield a detectable signal indicative of the presence or absence of the analyte; and a reader assembly comprising: a detection assembly (target nucleic acids) configured to detect the signal; and a communication assembly configured to receive an assay protocol in response to receiving an identity of the cartridge from an external device, the external device being separate from the reader assembly, the communication assembly further configured to transmit the signal to the external device.

US5939291A CLAIM 1. An amplification device for target nucleic acids (detection assembly) comprising a reaction chamber and at least one supply chamber, wherein amplicons complementary to a target nucleic acid segment of the target nucleic acid are generated in a reaction chamber within the device and form duplex amplicons between complementary amplicons, and wherein denaturation of the duplex amplicons is effected in the reaction chamber by a chemical denaturant or an electrostatic process wherein the device further comprises: an electric field generating device effective to create a field at a reaction chamber of the device such that the strands of amplicons in that chamber separate, wherein the amplicons are each formed from first primer and a second primer, where the first primers have one charge and the second primers have the opposite charge.

US10533994B2 Filed: 2006-03-24     Issued: 2020-01-14 Systems and methods of sample processing and fluid control in a fluidic system (Original Assignee) Theranos IP Co LLC     (Current Assignee) Theranos IP Co LLC Elizabeth A. Holmes, Shaunak Roy, Ian Gibbons, Shize Daniel Qi, Edmond Ku, Chris Todd, Melissa Takahashi, Bruce Johnson, Jeff Fenton, Keith Moravick, Uwe Springborn, Anthony Delacruz

US6267858B1 Filed: 1997-06-24     Issued: 2001-07-31 High throughput screening assay systems in microscale fluidic devices (Original Assignee) Caliper Technologies Corp     (Current Assignee) Caliper Life Sciences Inc J. Wallace Parce, Anne R. Kopf-Sill, Luc J. Bousse

US10533994B2 CLAIM 1. A system for detecting the presence or absence of an analyte in a bodily fluid sample obtained from a subject, comprising: a cartridge, comprising: a sample collection unit, comprising: a sample collection well configured to receive a portion of the sample; a metering channel in fluid communication (fluid communication) with the sample collection well and configured such that the sample flows from the sample collection well into the metering channel; and a metering element comprising a mechanically movable portion configured to be movable from an open position that permits fluid communication between the sample collection well and the metering channel to a closed position that does not provide fluid communication between the sample collection well, thereby isolating a specific volume of the sample in the metering channel; a lysing assembly configured to lyse cells present in the sample; and an assay assembly comprising a reaction site containing a reactant able to react with the analyte to yield a detectable signal indicative of the presence or absence of the analyte; and a reader assembly comprising: a detection assembly configured to detect the signal; and a communication assembly configured to receive an assay protocol in response to receiving an identity of the cartridge from an external device, the external device being separate from the reader assembly, the communication assembly further configured to transmit the signal to the external device.

US6267858B1 CLAIM 1. A microfluidic device, comprising: a body having at least a first microscale channel disposed therein; at least a first reservoir in fluid communication (fluid communication) with the first microscale channel, the first reservoir having no electrodes disposed therein; at least a second reservoir connected to the first reservoir by a second channel; and at least a first electrode place into contact with a fluid disposed in the second reservoir: wherein the second channel is configured to retard the movement of one or more degradable components between the electrode and the first microscale channel, the second channel comprising one or more of: a cross-sectional dimension that is smaller than a cross-sectional dimension of the first channel; and a cross-sectional dimension that is smaller than a cross-sectional dimension of the first channel.

US10533994B2 Filed: 2006-03-24     Issued: 2020-01-14 Systems and methods of sample processing and fluid control in a fluidic system (Original Assignee) Theranos IP Co LLC     (Current Assignee) Theranos IP Co LLC Elizabeth A. Holmes, Shaunak Roy, Ian Gibbons, Shize Daniel Qi, Edmond Ku, Chris Todd, Melissa Takahashi, Bruce Johnson, Jeff Fenton, Keith Moravick, Uwe Springborn, Anthony Delacruz

US20030061687A1 Filed: 2002-04-05     Issued: 2003-04-03 High throughput screening of crystallization materials (Original Assignee) California Institute of Technology     (Current Assignee) California Institute of Technology ; University of California Carl Hansen, Stephen Quake, James Berger

US10533994B2 CLAIM 1. A system for detecting the presence or absence of an analyte in a bodily fluid sample obtained from a subject, comprising: a cartridge, comprising: a sample collection unit, comprising: a sample collection well configured to receive a portion of the sample; a metering channel in fluid communication (fluid communication) with the sample collection well and configured such that the sample flows from the sample collection well into the metering channel; and a metering element comprising a mechanically movable portion configured to be movable from an open position that permits fluid communication between the sample collection well and the metering channel to a closed position that does not provide fluid communication between the sample collection well, thereby isolating a specific volume of the sample in the metering channel; a lysing assembly configured to lyse cells present in the sample; and an assay assembly comprising a reaction site containing a reactant able to react with the analyte to yield a detectable signal indicative of the presence or absence of the analyte; and a reader assembly comprising: a detection assembly configured to detect the signal; and a communication assembly configured to receive an assay protocol in response to receiving an identity of the cartridge from an external device, the external device being separate from the reader assembly, the communication assembly further configured to transmit the signal to the external device.

US20030061687A1 CLAIM 1 . A method for promoting interaction between two solutions, the method comprising: defining a first microfluidic chamber; priming the first microfluidic chamber with a first solution; defining a second microfluidic chamber; priming the second microfluidic chamber with a second solution; placing the first microfluidic chamber into fluid communication (fluid communication) with the second microfluidic chamber to define a microfluidic free interface between the first solution and the second solution; and permitting diffusion to occur between the first solution and the second solution such that the first solution interacts with the second solution.

US10533994B2 Filed: 2006-03-24     Issued: 2020-01-14 Systems and methods of sample processing and fluid control in a fluidic system (Original Assignee) Theranos IP Co LLC     (Current Assignee) Theranos IP Co LLC Elizabeth A. Holmes, Shaunak Roy, Ian Gibbons, Shize Daniel Qi, Edmond Ku, Chris Todd, Melissa Takahashi, Bruce Johnson, Jeff Fenton, Keith Moravick, Uwe Springborn, Anthony Delacruz	US5273905A Filed: 1991-02-22     Issued: 1993-12-28 Processing of slide mounted material (Original Assignee) BP Corp North America Inc     (Current Assignee) BP Corp North America Inc Uwe R. Muller, Lawrence J. Mika, Donald J. Lindley, Ernest J. Wisner
US10533994B2 CLAIM 14. The system of claim 10 , wherein the actuator element comprises a sealing member (said holding means) such that when the actuator element moves the sealing element the sealing member forms a substantially air tight seal (tight seal) such that the fluid can only flow through the channel.	US5273905A CLAIM 2. The apparatus for sequential, multi-step processing of biological material mounted on a surface of a slide of claim 28 wherein the relationship between said slide and said holding means (sealing member) is such that the initial volume of said chamber is not greater than about 500 microliters. US5273905A CLAIM 3. The apparatus of claim 1 wherein each said processing station further includes gasket means for making a fluid tight seal (tight seal) about the perimeter of said chamber.
US10533994B2 CLAIM 15. The system of claim 14 wherein the actuator element is substantially pin shaped and the sealing member (said holding means) is an O-ring adapted to be placed around the actuator element.	US5273905A CLAIM 2. The apparatus for sequential, multi-step processing of biological material mounted on a surface of a slide of claim 28 wherein the relationship between said slide and said holding means (sealing member) is such that the initial volume of said chamber is not greater than about 500 microliters.

US10533994B2 Filed: 2006-03-24     Issued: 2020-01-14 Systems and methods of sample processing and fluid control in a fluidic system (Original Assignee) Theranos IP Co LLC     (Current Assignee) Theranos IP Co LLC Elizabeth A. Holmes, Shaunak Roy, Ian Gibbons, Shize Daniel Qi, Edmond Ku, Chris Todd, Melissa Takahashi, Bruce Johnson, Jeff Fenton, Keith Moravick, Uwe Springborn, Anthony Delacruz

US20030069560A1 Filed: 2002-05-02     Issued: 2003-04-10 Implantable drug delivery device and use thereof (Original Assignee) Massachusetts Eye and Ear Infirmary     (Current Assignee) Charles Stark Draper Laboratory Inc ; Massachusetts Eye and Ear Infirmary Anthony Adamis, Joan Miller, Evangelos Gragoudas, Mark Mescher, Christopher Dube, Jeffrey Borenstein, Marcie Weinstein, Raanan Miller, Mitchell Hansberry

US10533994B2 CLAIM 1. A system for detecting the presence or absence of an analyte in a bodily fluid sample obtained from a subject, comprising: a cartridge, comprising: a sample collection unit, comprising: a sample collection well configured to receive a portion of the sample; a metering channel in fluid communication with the sample collection well and configured such that the sample flows from the sample collection well into the metering channel; and a metering element comprising a mechanically movable portion configured to be movable from an open position that permits fluid communication (spaced apart relation) between the sample collection well and the metering channel to a closed position that does not provide fluid communication between the sample collection well, thereby isolating a specific volume of the sample in the metering channel; a lysing assembly configured to lyse cells present in the sample; and an assay assembly comprising a reaction site containing a reactant able to react with the analyte to yield a detectable signal indicative of the presence or absence of the analyte; and a reader assembly comprising: a detection assembly configured to detect the signal; and a communication assembly configured to receive an assay protocol in response to receiving an identity of the cartridge from an external device, the external device being separate from the reader assembly, the communication assembly further configured to transmit the signal to the external device.

US20030069560A1 CLAIM 38 . The drug delivery device of claim 26 wherein the drum rotates about an axis from a first position in which the sealed cavity is in spaced apart relation (permits fluid communication) relative to the aperture port to a second position in which the cavity is adjacent the aperture port.

US10533994B2 Filed: 2006-03-24     Issued: 2020-01-14 Systems and methods of sample processing and fluid control in a fluidic system (Original Assignee) Theranos IP Co LLC     (Current Assignee) Theranos IP Co LLC Elizabeth A. Holmes, Shaunak Roy, Ian Gibbons, Shize Daniel Qi, Edmond Ku, Chris Todd, Melissa Takahashi, Bruce Johnson, Jeff Fenton, Keith Moravick, Uwe Springborn, Anthony Delacruz

US20020143437A1 Filed: 2001-03-28     Issued: 2002-10-03 Methods and systems for control of microfluidic devices (Original Assignee) HandyLab Inc     (Current Assignee) HandyLab Inc Kalyan Handique, Karthik Ganesan, Sundaresh Brahmasandra

US10533994B2 CLAIM 1. A system for detecting the presence or absence of an analyte in a bodily fluid sample obtained from a subject, comprising: a cartridge, comprising: a sample collection unit, comprising: a sample collection well configured to receive a portion of the sample; a metering channel in fluid communication with the sample collection well and configured such that the sample flows from the sample collection well into the metering channel; and a metering element comprising a mechanically movable portion configured to be movable from an open position that permits fluid communication (more internal components) between the sample collection well and the metering channel to a closed position that does not provide fluid communication between the sample collection well, thereby isolating a specific volume of the sample in the metering channel; a lysing assembly configured to lyse cells present in the sample; and an assay assembly comprising a reaction site containing a reactant able to react with the analyte to yield a detectable signal indicative of the presence or absence of the analyte; and a reader assembly comprising: a detection assembly configured to detect the signal; and a communication assembly configured to receive an assay protocol in response to receiving an identity of the cartridge from an external device, the external device being separate from the reader assembly, the communication assembly further configured to transmit the signal to the external device.

US20020143437A1 CLAIM 1 . A method for controlling the operation of a digital-type microfluidic (“MF”) device (i) wherein an MF device comprises one or more passages for confining one or more micro-droplets, the passages having one or more stable positions for the micro-droplets, and (ii) comprises one or more internal components (permits fluid communication) responsive to control signals, the internal components operatively associated with the passages for control and monitoring the MF device, the method comprising: (a) providing one or more micro-droplet processing requests, wherein a micro-droplet processing request specifies performing at least one action on at least one micro-droplet, the requests comprising either (i) creating one or more new micro-droplets at selected stable positions, or (ii) moving one or more micro-droplets from current stable positions to selected next stable positions, or (iii) combining two or more micro-droplets into one or more new micro-droplets at selected stable positions, or (iv) mixing one or more micro-droplets, and (b) generating control signals, which are provided to the MF device, wherein the control signals are generated in a pattern and sequence that is responsive to each micro-droplet processing request so that the internal components of the MF device that are responsive to the control signals function together to perform the requested micro-droplet processing in the MF device.

US10533994B2 Filed: 2006-03-24     Issued: 2020-01-14 Systems and methods of sample processing and fluid control in a fluidic system (Original Assignee) Theranos IP Co LLC     (Current Assignee) Theranos IP Co LLC Elizabeth A. Holmes, Shaunak Roy, Ian Gibbons, Shize Daniel Qi, Edmond Ku, Chris Todd, Melissa Takahashi, Bruce Johnson, Jeff Fenton, Keith Moravick, Uwe Springborn, Anthony Delacruz	US6664104B2 Filed: 2001-11-07     Issued: 2003-12-16 Device incorporating a microfluidic chip for separating analyte from a sample (Original Assignee) Cepheid Inc     (Current Assignee) Cepheid Inc Farzad Pourahmadi, William A. McMillan, Jesus Ching, Ronald Chang, Lee A. Christel, Gregory T. A. Kovacs, M. Allen Northrup, Kurt E. Petersen
US10533994B2 CLAIM 1. A system for detecting the presence or absence of an analyte in a bodily fluid (controlling fluid flow, second flow path) sample (controlling fluid flow, second flow path) obtained from a subject, comprising: a cartridge, comprising: a sample collection unit, comprising: a sample collection well configured to receive a portion of the sample; a metering channel in fluid communication (fluid communication) with the sample collection well and configured such that the sample flows from the sample collection well into the metering channel; and a metering element comprising a mechanically movable portion configured to be movable from an open position that permits fluid communication between the sample collection well and the metering channel to a closed position that does not provide fluid communication between the sample collection well, thereby isolating a specific volume of the sample in the metering channel; a lysing assembly configured to lyse cells present in the sample; and an assay assembly (controlling fluid flow, second flow path) comprising a reaction site containing a reactant able to react with the analyte to yield a detectable signal indicative of the presence or absence of the analyte; and a reader assembly comprising: a detection assembly (electrically conductive material) configured to detect the signal; and a communication assembly (electrically conductive material) configured to receive an assay protocol in response to receiving an identity of the cartridge from an external device, the external device being separate from the reader assembly, the communication assembly further configured to transmit the signal to the external device.	US6664104B2 CLAIM 1. A device for extracting an analyte from a sample, the device comprising a cartridge having: a) a first flow path that includes a flow-through chip for extracting the analyte from the sample, the chip comprising a body having formed therein: i) an extraction chamber; ii) at least one inlet port in fluid communication (fluid communication) with the extraction chamber; iii) at least one outlet port in fluid communication with the extraction chamber, wherein the inlet and outlet ports permit liquid flow through the extraction chamber and out of the chip; and iv) an array of microstructures extending into the extraction chamber for capturing the analyte from the sample as the sample flows through the chip and for subsequently releasing the captured analyte into an elution fluid as the elution fluid flows through the chip, wherein each of the microstructures has an aspect ratio (ratio of height to width or diameter) of at least 2:1; b) an elution flow path for eluting the captured analyte from the chip, wherein the elution flow path passes through the chip and diverges from the first flow path after passing through the chip; and c) at least one flow controller positioned downstream of the at least one outlet port to direct the remaining sample fluid, from which the analyte has been separated, to flow in the first flow path after the sample flows through the chip and to direct the eluted analyte to flow in the diverging elution flow path. US6664104B2 CLAIM 18. The device of claim 1 , wherein the body of the chip comprises an electrically conductive material (detection assembly, communication assembly) , and wherein the device further comprises electrodes for applying a voltage across at least one portion of the body to heat the microstructures. US6664104B2 CLAIM 26. The device of claim 1 , wherein the at least one flow controller comprises. i) a first flow controller for controlling fluid flow (bodily fluid sample, assay assembly, pressure means, assay reagent, bodily fluid, port engaging pressure means) through the first flow path; and ii) a second flow controller for controlling fluid flow through the diverging elution flow path. US6664104B2 CLAIM 27. A device for extracting an analyte from a sample, the device comprising a cartridge having a) a first flow path that includes: i) a lysing region for lysing sample components to produce a lysate containing the analyte; and ii) a flow-through chip for extracting the analyte from the lysate, the chip comprising a body having formed therein: i) an extraction chamber; ii) at least one inlet port in fluid communication with the extraction chamber; iii) at least one outlet port in fluid communication with the extraction chamber, wherein the inlet and outlet ports permit liquid flow through the extraction chamber and out of the chip; and iv) an array of microstructures extending into the extraction chamber for capturing the analyte from the lysate as the lysate flows through the chip and for subsequently releasing the captured analyte into an elution fluid as the elution fluid flows through the chip, wherein each of the microstructures has an aspect ration (ratio of height to width or diameter) of at least 2:1; b) a waste chamber for receiving waste fluid from the chip via the first flow path; c) a second flow path (bodily fluid sample, assay assembly, pressure means, assay reagent, bodily fluid, port engaging pressure means) for eluting the captured analyte from the chip, wherein the second flow path passes through the chip and diverges from the first flow path after passing through the chip; and d) at least one flow controller, positioned downstream of the at least one outlet port, for: i) directing the waste fluid exiting the chip to flow into the waste chamber and ii) directing the elution fluid exiting the chip to flow along the second flow path.
US10533994B2 CLAIM 4. The system of claim 2 , wherein the sample collection unit further comprises: a dilution chamber in fluidic communication with the metering channel, wherein the dilution chamber is configured to store a diluent and comprises a port engaging pressure means (controlling fluid flow, second flow path) transferring the diluent from the dilution chamber into the metering channel.	US6664104B2 CLAIM 26. The device of claim 1 , wherein the at least one flow controller comprises. i) a first flow controller for controlling fluid flow (bodily fluid sample, assay assembly, pressure means, assay reagent, bodily fluid, port engaging pressure means) through the first flow path; and ii) a second flow controller for controlling fluid flow through the diverging elution flow path. US6664104B2 CLAIM 27. A device for extracting an analyte from a sample, the device comprising a cartridge having a) a first flow path that includes: i) a lysing region for lysing sample components to produce a lysate containing the analyte; and ii) a flow-through chip for extracting the analyte from the lysate, the chip comprising a body having formed therein: i) an extraction chamber; ii) at least one inlet port in fluid communication with the extraction chamber; iii) at least one outlet port in fluid communication with the extraction chamber, wherein the inlet and outlet ports permit liquid flow through the extraction chamber and out of the chip; and iv) an array of microstructures extending into the extraction chamber for capturing the analyte from the lysate as the lysate flows through the chip and for subsequently releasing the captured analyte into an elution fluid as the elution fluid flows through the chip, wherein each of the microstructures has an aspect ration (ratio of height to width or diameter) of at least 2:1; b) a waste chamber for receiving waste fluid from the chip via the first flow path; c) a second flow path (bodily fluid sample, assay assembly, pressure means, assay reagent, bodily fluid, port engaging pressure means) for eluting the captured analyte from the chip, wherein the second flow path passes through the chip and diverges from the first flow path after passing through the chip; and d) at least one flow controller, positioned downstream of the at least one outlet port, for: i) directing the waste fluid exiting the chip to flow into the waste chamber and ii) directing the elution fluid exiting the chip to flow along the second flow path.
US10533994B2 CLAIM 8. The system of claim 1 , wherein the assay assembly (controlling fluid flow, second flow path) is adapted to run an immunoassay.	US6664104B2 CLAIM 26. The device of claim 1 , wherein the at least one flow controller comprises. i) a first flow controller for controlling fluid flow (bodily fluid sample, assay assembly, pressure means, assay reagent, bodily fluid, port engaging pressure means) through the first flow path; and ii) a second flow controller for controlling fluid flow through the diverging elution flow path. US6664104B2 CLAIM 27. A device for extracting an analyte from a sample, the device comprising a cartridge having a) a first flow path that includes: i) a lysing region for lysing sample components to produce a lysate containing the analyte; and ii) a flow-through chip for extracting the analyte from the lysate, the chip comprising a body having formed therein: i) an extraction chamber; ii) at least one inlet port in fluid communication with the extraction chamber; iii) at least one outlet port in fluid communication with the extraction chamber, wherein the inlet and outlet ports permit liquid flow through the extraction chamber and out of the chip; and iv) an array of microstructures extending into the extraction chamber for capturing the analyte from the lysate as the lysate flows through the chip and for subsequently releasing the captured analyte into an elution fluid as the elution fluid flows through the chip, wherein each of the microstructures has an aspect ration (ratio of height to width or diameter) of at least 2:1; b) a waste chamber for receiving waste fluid from the chip via the first flow path; c) a second flow path (bodily fluid sample, assay assembly, pressure means, assay reagent, bodily fluid, port engaging pressure means) for eluting the captured analyte from the chip, wherein the second flow path passes through the chip and diverges from the first flow path after passing through the chip; and d) at least one flow controller, positioned downstream of the at least one outlet port, for: i) directing the waste fluid exiting the chip to flow into the waste chamber and ii) directing the elution fluid exiting the chip to flow along the second flow path.
US10533994B2 CLAIM 9. The system of claim 8 , wherein the assay assembly (controlling fluid flow, second flow path) comprises a reagent chamber (reagent chamber) in fluidic communication with the reaction site, wherein the reagent chamber is configured to store an assay reagent.	US6664104B2 CLAIM 3. The device of claim 1 , wherein the cartridge further includes a reagent chamber (reagent chamber) for receiving the eluted analyte via the elution flow path, the reagent chamber containing dried or lyophilized reagents. US6664104B2 CLAIM 26. The device of claim 1 , wherein the at least one flow controller comprises. i) a first flow controller for controlling fluid flow (bodily fluid sample, assay assembly, pressure means, assay reagent, bodily fluid, port engaging pressure means) through the first flow path; and ii) a second flow controller for controlling fluid flow through the diverging elution flow path. US6664104B2 CLAIM 27. A device for extracting an analyte from a sample, the device comprising a cartridge having a) a first flow path that includes: i) a lysing region for lysing sample components to produce a lysate containing the analyte; and ii) a flow-through chip for extracting the analyte from the lysate, the chip comprising a body having formed therein: i) an extraction chamber; ii) at least one inlet port in fluid communication with the extraction chamber; iii) at least one outlet port in fluid communication with the extraction chamber, wherein the inlet and outlet ports permit liquid flow through the extraction chamber and out of the chip; and iv) an array of microstructures extending into the extraction chamber for capturing the analyte from the lysate as the lysate flows through the chip and for subsequently releasing the captured analyte into an elution fluid as the elution fluid flows through the chip, wherein each of the microstructures has an aspect ration (ratio of height to width or diameter) of at least 2:1; b) a waste chamber for receiving waste fluid from the chip via the first flow path; c) a second flow path (bodily fluid sample, assay assembly, pressure means, assay reagent, bodily fluid, port engaging pressure means) for eluting the captured analyte from the chip, wherein the second flow path passes through the chip and diverges from the first flow path after passing through the chip; and d) at least one flow controller, positioned downstream of the at least one outlet port, for: i) directing the waste fluid exiting the chip to flow into the waste chamber and ii) directing the elution fluid exiting the chip to flow along the second flow path.
US10533994B2 CLAIM 10. The system of claim 1 , wherein the reaction site of the assay assembly (controlling fluid flow, second flow path) is in fluidic communication with the sample collection unit, the reaction site containing a reactant that reacts with the analyte to yield a signal indicative of the presence of the analyte; and the assay assembly further comprises: a reagent chamber (reagent chamber) in fluidic communication with the reaction site, wherein the reagent chamber is configured to store an assay reagent; a fluidic channel connecting the reagent chamber with the reaction site; and an actuatable valve assembly configured to control the flow of reagent through the fluidic channel, wherein the valve assembly comprises a sealing element and actuator element, wherein the channel comprises first and second locations, wherein the sealing element positioned in the first location obstructs the flow of fluid through the channel and the sealing element positioned in the second location allows the flow of fluid through the channel, and wherein the actuator element is adapted to move the sealing element from the first location to the second location.	US6664104B2 CLAIM 3. The device of claim 1 , wherein the cartridge further includes a reagent chamber (reagent chamber) for receiving the eluted analyte via the elution flow path, the reagent chamber containing dried or lyophilized reagents. US6664104B2 CLAIM 26. The device of claim 1 , wherein the at least one flow controller comprises. i) a first flow controller for controlling fluid flow (bodily fluid sample, assay assembly, pressure means, assay reagent, bodily fluid, port engaging pressure means) through the first flow path; and ii) a second flow controller for controlling fluid flow through the diverging elution flow path. US6664104B2 CLAIM 27. A device for extracting an analyte from a sample, the device comprising a cartridge having a) a first flow path that includes: i) a lysing region for lysing sample components to produce a lysate containing the analyte; and ii) a flow-through chip for extracting the analyte from the lysate, the chip comprising a body having formed therein: i) an extraction chamber; ii) at least one inlet port in fluid communication with the extraction chamber; iii) at least one outlet port in fluid communication with the extraction chamber, wherein the inlet and outlet ports permit liquid flow through the extraction chamber and out of the chip; and iv) an array of microstructures extending into the extraction chamber for capturing the analyte from the lysate as the lysate flows through the chip and for subsequently releasing the captured analyte into an elution fluid as the elution fluid flows through the chip, wherein each of the microstructures has an aspect ration (ratio of height to width or diameter) of at least 2:1; b) a waste chamber for receiving waste fluid from the chip via the first flow path; c) a second flow path (bodily fluid sample, assay assembly, pressure means, assay reagent, bodily fluid, port engaging pressure means) for eluting the captured analyte from the chip, wherein the second flow path passes through the chip and diverges from the first flow path after passing through the chip; and d) at least one flow controller, positioned downstream of the at least one outlet port, for: i) directing the waste fluid exiting the chip to flow into the waste chamber and ii) directing the elution fluid exiting the chip to flow along the second flow path.
US10533994B2 CLAIM 16. The fluidic device of claim 10 , wherein the assay assembly (controlling fluid flow, second flow path) is adapted to run an immunoassay.	US6664104B2 CLAIM 26. The device of claim 1 , wherein the at least one flow controller comprises. i) a first flow controller for controlling fluid flow (bodily fluid sample, assay assembly, pressure means, assay reagent, bodily fluid, port engaging pressure means) through the first flow path; and ii) a second flow controller for controlling fluid flow through the diverging elution flow path. US6664104B2 CLAIM 27. A device for extracting an analyte from a sample, the device comprising a cartridge having a) a first flow path that includes: i) a lysing region for lysing sample components to produce a lysate containing the analyte; and ii) a flow-through chip for extracting the analyte from the lysate, the chip comprising a body having formed therein: i) an extraction chamber; ii) at least one inlet port in fluid communication with the extraction chamber; iii) at least one outlet port in fluid communication with the extraction chamber, wherein the inlet and outlet ports permit liquid flow through the extraction chamber and out of the chip; and iv) an array of microstructures extending into the extraction chamber for capturing the analyte from the lysate as the lysate flows through the chip and for subsequently releasing the captured analyte into an elution fluid as the elution fluid flows through the chip, wherein each of the microstructures has an aspect ration (ratio of height to width or diameter) of at least 2:1; b) a waste chamber for receiving waste fluid from the chip via the first flow path; c) a second flow path (bodily fluid sample, assay assembly, pressure means, assay reagent, bodily fluid, port engaging pressure means) for eluting the captured analyte from the chip, wherein the second flow path passes through the chip and diverges from the first flow path after passing through the chip; and d) at least one flow controller, positioned downstream of the at least one outlet port, for: i) directing the waste fluid exiting the chip to flow into the waste chamber and ii) directing the elution fluid exiting the chip to flow along the second flow path.
US10533994B2 CLAIM 17. The system of claim 10 , wherein the sample of bodily fluid (controlling fluid flow, second flow path) is less than 50 μl.	US6664104B2 CLAIM 26. The device of claim 1 , wherein the at least one flow controller comprises. i) a first flow controller for controlling fluid flow (bodily fluid sample, assay assembly, pressure means, assay reagent, bodily fluid, port engaging pressure means) through the first flow path; and ii) a second flow controller for controlling fluid flow through the diverging elution flow path. US6664104B2 CLAIM 27. A device for extracting an analyte from a sample, the device comprising a cartridge having a) a first flow path that includes: i) a lysing region for lysing sample components to produce a lysate containing the analyte; and ii) a flow-through chip for extracting the analyte from the lysate, the chip comprising a body having formed therein: i) an extraction chamber; ii) at least one inlet port in fluid communication with the extraction chamber; iii) at least one outlet port in fluid communication with the extraction chamber, wherein the inlet and outlet ports permit liquid flow through the extraction chamber and out of the chip; and iv) an array of microstructures extending into the extraction chamber for capturing the analyte from the lysate as the lysate flows through the chip and for subsequently releasing the captured analyte into an elution fluid as the elution fluid flows through the chip, wherein each of the microstructures has an aspect ration (ratio of height to width or diameter) of at least 2:1; b) a waste chamber for receiving waste fluid from the chip via the first flow path; c) a second flow path (bodily fluid sample, assay assembly, pressure means, assay reagent, bodily fluid, port engaging pressure means) for eluting the captured analyte from the chip, wherein the second flow path passes through the chip and diverges from the first flow path after passing through the chip; and d) at least one flow controller, positioned downstream of the at least one outlet port, for: i) directing the waste fluid exiting the chip to flow into the waste chamber and ii) directing the elution fluid exiting the chip to flow along the second flow path.

US10533994B2 Filed: 2006-03-24     Issued: 2020-01-14 Systems and methods of sample processing and fluid control in a fluidic system (Original Assignee) Theranos IP Co LLC     (Current Assignee) Theranos IP Co LLC Elizabeth A. Holmes, Shaunak Roy, Ian Gibbons, Shize Daniel Qi, Edmond Ku, Chris Todd, Melissa Takahashi, Bruce Johnson, Jeff Fenton, Keith Moravick, Uwe Springborn, Anthony Delacruz	US20020034757A1 Filed: 2001-07-17     Issued: 2002-03-21 Single-molecule selection methods and compositions therefrom (Original Assignee) Cubicciotti Roger S.      Roger Cubicciotti
US10533994B2 CLAIM 1. A system for detecting the presence or absence of an analyte in a bodily fluid sample obtained from a subject, comprising: a cartridge, comprising: a sample collection unit, comprising: a sample collection well configured to receive a portion of the sample; a metering channel in fluid communication with the sample collection well and configured such that the sample flows from the sample collection well into the metering channel; and a metering element comprising a mechanically movable portion configured to be movable from an open position that permits fluid communication between the sample collection well and the metering channel to a closed position that does not provide fluid communication between the sample collection well, thereby isolating a specific volume of the sample in the metering channel; a lysing assembly configured to lyse cells present in the sample; and an assay assembly comprising a reaction site (drug delivery systems) containing a reactant able to react with the analyte to yield a detectable signal indicative of the presence or absence of the analyte; and a reader assembly comprising: a detection assembly configured to detect the signal; and a communication assembly configured to receive an assay protocol in response to receiving an identity of the cartridge from an external device, the external device being separate from the reader assembly, the communication assembly further configured to transmit the signal to the external device.	US20020034757A1 CLAIM 128 . An immobilized multimolecular structure comprising a solid support and a multimolecular structure immobilized to the solid support wherein the multimolecular structure is selected from the group consisting of aptameric multimolecular devices, heteropolymeric discrete structures, multivalent heteropolymeric hybrid structures, synthetic heteropolymers, tethered specific recognition devices, paired specific recognition devices, nonaptameric multimolecular devices, multivalent molecular structures, multivalent imprints, and multimolecular drug delivery systems (reaction site) .
US10533994B2 CLAIM 10. The system of claim 1 , wherein the reaction site (drug delivery systems) of the assay assembly is in fluidic communication with the sample collection unit, the reaction site containing a reactant that reacts with the analyte to yield a signal indicative of the presence of the analyte; and the assay assembly further comprises: a reagent chamber in fluidic communication with the reaction site, wherein the reagent chamber is configured to store an assay reagent; a fluidic channel connecting the reagent chamber with the reaction site; and an actuatable valve assembly configured to control the flow of reagent through the fluidic channel, wherein the valve assembly comprises a sealing element and actuator element, wherein the channel comprises first and second locations, wherein the sealing element positioned in the first location obstructs the flow of fluid through the channel and the sealing element positioned in the second location allows the flow of fluid through the channel, and wherein the actuator element is adapted to move the sealing element from the first location to the second location.	US20020034757A1 CLAIM 128 . An immobilized multimolecular structure comprising a solid support and a multimolecular structure immobilized to the solid support wherein the multimolecular structure is selected from the group consisting of aptameric multimolecular devices, heteropolymeric discrete structures, multivalent heteropolymeric hybrid structures, synthetic heteropolymers, tethered specific recognition devices, paired specific recognition devices, nonaptameric multimolecular devices, multivalent molecular structures, multivalent imprints, and multimolecular drug delivery systems (reaction site) .

US10533994B2 Filed: 2006-03-24     Issued: 2020-01-14 Systems and methods of sample processing and fluid control in a fluidic system (Original Assignee) Theranos IP Co LLC     (Current Assignee) Theranos IP Co LLC Elizabeth A. Holmes, Shaunak Roy, Ian Gibbons, Shize Daniel Qi, Edmond Ku, Chris Todd, Melissa Takahashi, Bruce Johnson, Jeff Fenton, Keith Moravick, Uwe Springborn, Anthony Delacruz	US6632216B2 Filed: 2000-12-20     Issued: 2003-10-14 Ingestible device (Original Assignee) Phaeton Res Ltd     (Current Assignee) PHAETON RESEARCH Ltd ; Phaeton Res Ltd Peter J. Houzego, Peter N. Morgan, Peter H. Hirst, Duncan J. Westland, Ian R. Wilding
US10533994B2 CLAIM 4. The system of claim 2 , wherein the sample collection unit further comprises: a dilution chamber in fluidic communication with the metering channel, wherein the dilution chamber is configured to store a diluent and comprises a port engaging pressure means (cross sectional area) transferring the diluent from the dilution chamber into the metering channel.	US6632216B2 CLAIM 14. A device according to claim 13 wherein the retainer includes a rib that reduces the cross sectional area (port engaging pressure means) of the hollow interior of the device in the vicinity of an opening therein.

US10533994B2 Filed: 2006-03-24     Issued: 2020-01-14 Systems and methods of sample processing and fluid control in a fluidic system (Original Assignee) Theranos IP Co LLC     (Current Assignee) Theranos IP Co LLC Elizabeth A. Holmes, Shaunak Roy, Ian Gibbons, Shize Daniel Qi, Edmond Ku, Chris Todd, Melissa Takahashi, Bruce Johnson, Jeff Fenton, Keith Moravick, Uwe Springborn, Anthony Delacruz

US20030153900A1 Filed: 2002-04-23     Issued: 2003-08-14 Autonomous, ambulatory analyte monitor or drug delivery device (Original Assignee) Sarnoff Corp     (Current Assignee) Intuity Medical Inc John Aceti, Sterling McBride, Richard Moroney, Christopher Gregory, Peter Zanzucchi

US10533994B2 CLAIM 1. A system for detecting the presence or absence of an analyte in a bodily fluid sample obtained from a subject, comprising: a cartridge, comprising: a sample collection unit, comprising: a sample collection well configured to receive a portion of the sample; a metering channel in fluid communication (fluid communication) with the sample collection well and configured such that the sample flows from the sample collection well into the metering channel; and a metering element comprising a mechanically movable portion configured to be movable from an open position that permits fluid communication between the sample collection well and the metering channel to a closed position that does not provide fluid communication between the sample collection well, thereby isolating a specific volume of the sample in the metering channel; a lysing assembly configured to lyse cells present in the sample; and an assay assembly comprising a reaction site containing a reactant able to react with the analyte to yield a detectable signal indicative of the presence or absence of the analyte; and a reader assembly comprising: a detection assembly configured to detect the signal; and a communication assembly configured to receive an assay protocol in response to receiving an identity of the cartridge from an external device, the external device being separate from the reader assembly, the communication assembly further configured to transmit the signal to the external device.

US20030153900A1 CLAIM 1 . An analyte monitoring device operable to draw a fluid sample from a subject, the device comprising: a first plurality of microneedles, a plurality of monitoring microchannels, wherein each of the first plurality of microneedles is at least intermittently in fluid communication (fluid communication) with a corresponding monitoring microchannel, and wherein each monitoring microchannel is associated with a reagent, at least one actuator operable to extend each microneedle to draw the fluid sample from the subject, and a controller operable to initiate analyte testing of the fluid sample.

US10533994B2 Filed: 2006-03-24     Issued: 2020-01-14 Systems and methods of sample processing and fluid control in a fluidic system (Original Assignee) Theranos IP Co LLC     (Current Assignee) Theranos IP Co LLC Elizabeth A. Holmes, Shaunak Roy, Ian Gibbons, Shize Daniel Qi, Edmond Ku, Chris Todd, Melissa Takahashi, Bruce Johnson, Jeff Fenton, Keith Moravick, Uwe Springborn, Anthony Delacruz	US20040096959A1 Filed: 2003-12-29     Issued: 2004-05-20 Analyte measurement (Original Assignee) LifeScan Scotland Ltd     (Current Assignee) Lifescan IP Holdings LLC Matthias Stiene, Tanja Richter, John Allen, Jerome McAleer
US10533994B2 CLAIM 1. A system for detecting the presence or absence of an analyte in a bodily fluid (bodily fluid) sample obtained from a subject, comprising: a cartridge, comprising: a sample collection (sample collection) unit, comprising: a sample collection well configured to receive a portion of the sample; a metering channel in fluid communication (fluid communication) with the sample collection well and configured such that the sample flows from the sample collection well into the metering channel; and a metering element comprising a mechanically movable portion configured to be movable from an open position that permits fluid communication between the sample collection well and the metering channel to a closed position that does not provide fluid communication between the sample collection well, thereby isolating a specific volume of the sample in the metering channel; a lysing assembly configured to lyse cells present in the sample; and an assay assembly comprising a reaction site containing a reactant able to react with the analyte to yield a detectable signal indicative of the presence or absence of the analyte; and a reader assembly comprising: a detection assembly (electrically conductive material) configured to detect the signal; and a communication assembly (electrically conductive material) configured to receive an assay protocol in response to receiving an identity of the cartridge from an external device, the external device being separate from the reader assembly, the communication assembly further configured to transmit the signal to the external device.	US20040096959A1 CLAIM 6 . A device for measuring the concentration of an analyte in a fluid, comprising a support member, analyte sensing means provided thereon for measuring said concentration and a microchannel in fluid communication (fluid communication) with said analyte sensing means for conveying said fluid to said sensing means. US20040096959A1 CLAIM 17 . A device for measuring the concentration of an analyte in a bodily fluid (bodily fluid) , comprising skin penetration means, said penetration means being sufficiently short so as to penetrate only the cutaneous layer of skin without penetrating the sub-cutaneous layer, and a support member, said support member comprising an analyte sensing site and a microchannel for conducting said body fluid from said penetration member to said analyte sensing site. US20040096959A1 CLAIM 40 . A device for making a plurality of measurements of the concentration of an analyte in a fluid comprising a common sample collection (sample collection) site in fluid communication with the fluid to be measured and a plurality of sensing means for measuring said concentration. US20040096959A1 CLAIM 82 . A method of making a device for measuring the concentration of a substance in a liquid comprising forming a first channel in a substrate material, fitting said channel at least partially with an electrically conductive material (detection assembly, communication assembly) , and forming a second channel so as to intersect said first channel, thereby forming two conductive portions on respective opposite sides of the second channel.
US10533994B2 CLAIM 4. The system of claim 2 , wherein the sample collection (sample collection) unit further comprises: a dilution chamber in fluidic communication with the metering channel, wherein the dilution chamber is configured to store a diluent and comprises a port engaging pressure means transferring the diluent from the dilution chamber into the metering channel.	US20040096959A1 CLAIM 40 . A device for making a plurality of measurements of the concentration of an analyte in a fluid comprising a common sample collection (sample collection) site in fluid communication with the fluid to be measured and a plurality of sensing means for measuring said concentration.
US10533994B2 CLAIM 5. The system of claim 4 , wherein the sample collection (sample collection) unit further comprises a mixing chamber in fluidic communication with the metering channel, the mixing chamber being configured to mix the predetermined portion of the sample with the diluent to yield a diluted sample.	US20040096959A1 CLAIM 40 . A device for making a plurality of measurements of the concentration of an analyte in a fluid comprising a common sample collection (sample collection) site in fluid communication with the fluid to be measured and a plurality of sensing means for measuring said concentration.
US10533994B2 CLAIM 6. The system of claim 5 , wherein the sample collection (sample collection) unit further comprises a filter configured to filter the diluted sample before it is assayed.	US20040096959A1 CLAIM 40 . A device for making a plurality of measurements of the concentration of an analyte in a fluid comprising a common sample collection (sample collection) site in fluid communication with the fluid to be measured and a plurality of sensing means for measuring said concentration.
US10533994B2 CLAIM 10. The system of claim 1 , wherein the reaction site of the assay assembly is in fluidic communication with the sample collection (sample collection) unit, the reaction site containing a reactant that reacts with the analyte to yield a signal indicative of the presence of the analyte; and the assay assembly further comprises: a reagent chamber in fluidic communication with the reaction site, wherein the reagent chamber is configured to store an assay reagent; a fluidic channel connecting the reagent chamber with the reaction site; and an actuatable valve assembly configured to control the flow of reagent through the fluidic channel, wherein the valve assembly comprises a sealing element and actuator element, wherein the channel comprises first and second locations, wherein the sealing element positioned in the first location (electric field generator) obstructs the flow of fluid through the channel and the sealing element positioned in the second location allows the flow of fluid through the channel, and wherein the actuator element is adapted to move the sealing element from the first location to the second location.	US20040096959A1 CLAIM 40 . A device for making a plurality of measurements of the concentration of an analyte in a fluid comprising a common sample collection (sample collection) site in fluid communication with the fluid to be measured and a plurality of sensing means for measuring said concentration. US20040096959A1 CLAIM 119 . An apparatus according to claim 111 further comprising an electric field generator (first location) for stimulating the skin layer and urging fluid to flow to said entrance.
US10533994B2 CLAIM 17. The system of claim 10 , wherein the sample of bodily fluid (bodily fluid) is less than 50 μl.	US20040096959A1 CLAIM 17 . A device for measuring the concentration of an analyte in a bodily fluid (bodily fluid) , comprising skin penetration means, said penetration means being sufficiently short so as to penetrate only the cutaneous layer of skin without penetrating the sub-cutaneous layer, and a support member, said support member comprising an analyte sensing site and a microchannel for conducting said body fluid from said penetration member to said analyte sensing site.

US10533994B2 Filed: 2006-03-24     Issued: 2020-01-14 Systems and methods of sample processing and fluid control in a fluidic system (Original Assignee) Theranos IP Co LLC     (Current Assignee) Theranos IP Co LLC Elizabeth A. Holmes, Shaunak Roy, Ian Gibbons, Shize Daniel Qi, Edmond Ku, Chris Todd, Melissa Takahashi, Bruce Johnson, Jeff Fenton, Keith Moravick, Uwe Springborn, Anthony Delacruz	US20020059030A1 Filed: 2001-07-17     Issued: 2002-05-16 Method and apparatus for the processing of remotely collected electronic information characterizing properties of biological entities (Original Assignee) Otworth Michael J.; Scott John S.; Blackwell Enoch Scott; Mcmorris John A.; Packard Meagan J.; Andrew Cole; Mullins Gregory A.; Acosta Galo F.; Ferrans Richard H.      Michael Otworth, John Scott, Enoch Blackwell, John McMorris, Meagan Packard, Andrew Cole, Gregory Mullins, Galo Acosta, Richard Ferrans
US10533994B2 CLAIM 1. A system for detecting the presence or absence of an analyte in a bodily fluid sample obtained from a subject, comprising: a cartridge, comprising: a sample collection (sample collection) unit, comprising: a sample collection well configured to receive a portion of the sample; a metering channel in fluid communication with the sample collection well and configured such that the sample flows from the sample collection well into the metering channel; and a metering element comprising a mechanically movable portion configured to be movable from an open position that permits fluid communication between the sample collection well and the metering channel to a closed position that does not provide fluid communication between the sample collection well, thereby isolating a specific volume of the sample in the metering channel; a lysing assembly configured to lyse cells present in the sample; and an assay assembly comprising a reaction site containing a reactant able to react with the analyte to yield a detectable signal indicative of the presence or absence of the analyte; and a reader assembly comprising: a detection assembly configured to detect the signal; and a communication assembly configured to receive an assay protocol in response to receiving an identity of the cartridge from an external device, the external device being separate from the reader assembly, the communication assembly further configured to transmit the signal to the external device.	US20020059030A1 CLAIM 23 . The method of claim 1 , wherein the testing kit contains at least one of a disposable sample cartridge, a re-useable sample collection (sample collection) cartridge, and a sample transport cartridge.
US10533994B2 CLAIM 4. The system of claim 2 , wherein the sample collection (sample collection) unit further comprises: a dilution chamber in fluidic communication with the metering channel, wherein the dilution chamber is configured to store a diluent and comprises a port engaging pressure means transferring the diluent from the dilution chamber into the metering channel.	US20020059030A1 CLAIM 23 . The method of claim 1 , wherein the testing kit contains at least one of a disposable sample cartridge, a re-useable sample collection (sample collection) cartridge, and a sample transport cartridge.
US10533994B2 CLAIM 5. The system of claim 4 , wherein the sample collection (sample collection) unit further comprises a mixing chamber in fluidic communication with the metering channel, the mixing chamber being configured to mix the predetermined portion of the sample with the diluent to yield a diluted sample.	US20020059030A1 CLAIM 23 . The method of claim 1 , wherein the testing kit contains at least one of a disposable sample cartridge, a re-useable sample collection (sample collection) cartridge, and a sample transport cartridge.
US10533994B2 CLAIM 6. The system of claim 5 , wherein the sample collection (sample collection) unit further comprises a filter configured to filter the diluted sample before it is assayed.	US20020059030A1 CLAIM 23 . The method of claim 1 , wherein the testing kit contains at least one of a disposable sample cartridge, a re-useable sample collection (sample collection) cartridge, and a sample transport cartridge.
US10533994B2 CLAIM 10. The system of claim 1 , wherein the reaction site of the assay assembly is in fluidic communication with the sample collection (sample collection) unit, the reaction site containing a reactant that reacts with the analyte to yield a signal indicative of the presence of the analyte; and the assay assembly further comprises: a reagent chamber in fluidic communication with the reaction site, wherein the reagent chamber is configured to store an assay reagent; a fluidic channel connecting the reagent chamber with the reaction site; and an actuatable valve assembly configured to control the flow of reagent through the fluidic channel, wherein the valve assembly comprises a sealing element and actuator element, wherein the channel comprises first and second locations, wherein the sealing element positioned in the first location obstructs the flow of fluid through the channel and the sealing element positioned in the second location allows the flow of fluid through the channel, and wherein the actuator element is adapted to move the sealing element from the first location to the second location.	US20020059030A1 CLAIM 23 . The method of claim 1 , wherein the testing kit contains at least one of a disposable sample cartridge, a re-useable sample collection (sample collection) cartridge, and a sample transport cartridge.

US10533994B2 Filed: 2006-03-24     Issued: 2020-01-14 Systems and methods of sample processing and fluid control in a fluidic system (Original Assignee) Theranos IP Co LLC     (Current Assignee) Theranos IP Co LLC Elizabeth A. Holmes, Shaunak Roy, Ian Gibbons, Shize Daniel Qi, Edmond Ku, Chris Todd, Melissa Takahashi, Bruce Johnson, Jeff Fenton, Keith Moravick, Uwe Springborn, Anthony Delacruz	US20020055167A1 Filed: 2001-11-07     Issued: 2002-05-09 Device incorporating a microfluidic chip for separating analyte from a sample (Original Assignee) Cepheid Inc     (Current Assignee) Cepheid Inc Farzad Pourahmadi, William McMillan, Jesus Ching, Ronald Chang, Lee Christel, Gregory Kovacs, M. Northrup, Kurt Petersen
US10533994B2 CLAIM 1. A system for detecting the presence or absence of an analyte in a bodily fluid sample (second flow path) obtained from a subject, comprising: a cartridge, comprising: a sample collection unit, comprising: a sample collection well configured to receive a portion of the sample; a metering channel in fluid communication (fluid communication) with the sample collection well and configured such that the sample flows from the sample collection well into the metering channel; and a metering element comprising a mechanically movable portion configured to be movable from an open position that permits fluid communication between the sample collection well and the metering channel to a closed position that does not provide fluid communication between the sample collection well, thereby isolating a specific volume of the sample in the metering channel; a lysing assembly configured to lyse cells present in the sample; and an assay assembly comprising a reaction site containing a reactant able to react with the analyte to yield a detectable signal indicative of the presence or absence of the analyte; and a reader assembly comprising: a detection assembly configured to detect the signal; and a communication assembly configured to receive an assay protocol in response to receiving an identity of the cartridge from an external device, the external device being separate from the reader assembly, the communication assembly further configured to transmit the signal to the external device.	US20020055167A1 CLAIM 1 . A device for separating an analyte from a fluid sample, the device comprising a cartridge having: a) a sample port for introducing the sample into the cartridge; b) a first flow path extending from the sample port; c) a microfluidic chip positioned in the first flow path, the microfluidic chip comprising a body having formed therein: i) an extraction chamber; ii) an inlet port in fluid communication (fluid communication) with the extraction chamber; iii) an outlet port in fluid communication with the extraction chamber, wherein the inlet and outlet ports are positioned to permit fluid flow through the extraction chamber and out of the microfluidic chip; and iv) an array of microstructures, integrally formed with at least one wall of the extraction chamber and extending into the extraction chamber, for capturing the analyte from the sample as the sample flows through the extraction chamber and for subsequently releasing the captured analyte into an elution fluid as the elution fluid flows through the extraction chamber, wherein each of the microstructures has an aspect ratio of at least 2:1; d) a second flow path (bodily fluid sample) for eluting the captured analyte from the microfluidic chip, wherein the second flow path passes through the chip and diverges from the first flow path after passing through the chip; and e) at least one flow controller for directing the sample into the first flow path after the sample flows through the microfluidic chip and for directing the eluted analyte into the second flow path.
US10533994B2 CLAIM 9. The system of claim 8 , wherein the assay assembly comprises a reagent chamber (reagent chamber) in fluidic communication with the reaction site, wherein the reagent chamber is configured to store an assay reagent.	US20020055167A1 CLAIM 5 . The device of claim 2 , wherein the cartridge further includes a reagent chamber (reagent chamber) in fluid communication with the lysing region for holding a lysing reagent and for releasing the lysing reagent into the lysing region.
US10533994B2 CLAIM 10. The system of claim 1 , wherein the reaction site of the assay assembly is in fluidic communication with the sample collection unit, the reaction site containing a reactant that reacts with the analyte to yield a signal indicative of the presence of the analyte; and the assay assembly further comprises: a reagent chamber (reagent chamber) in fluidic communication with the reaction site, wherein the reagent chamber is configured to store an assay reagent; a fluidic channel connecting the reagent chamber with the reaction site; and an actuatable valve assembly configured to control the flow of reagent through the fluidic channel, wherein the valve assembly comprises a sealing element and actuator element, wherein the channel comprises first and second locations, wherein the sealing element positioned in the first location obstructs the flow of fluid through the channel and the sealing element positioned in the second location allows the flow of fluid through the channel, and wherein the actuator element is adapted to move the sealing element from the first location to the second location.	US20020055167A1 CLAIM 5 . The device of claim 2 , wherein the cartridge further includes a reagent chamber (reagent chamber) in fluid communication with the lysing region for holding a lysing reagent and for releasing the lysing reagent into the lysing region.

US10533994B2 Filed: 2006-03-24     Issued: 2020-01-14 Systems and methods of sample processing and fluid control in a fluidic system (Original Assignee) Theranos IP Co LLC     (Current Assignee) Theranos IP Co LLC Elizabeth A. Holmes, Shaunak Roy, Ian Gibbons, Shize Daniel Qi, Edmond Ku, Chris Todd, Melissa Takahashi, Bruce Johnson, Jeff Fenton, Keith Moravick, Uwe Springborn, Anthony Delacruz	US6368275B1 Filed: 1999-10-07     Issued: 2002-04-09 Method and apparatus for diagnostic medical information gathering, hyperthermia treatment, or directed gene therapy (Original Assignee) Acuson Corp     (Current Assignee) Acuson Corp ; Siemens Medical Solutions USA Inc John W. Sliwa, William R. Dreschel
US10533994B2 CLAIM 4. The system of claim 2 , wherein the sample collection unit further comprises: a dilution chamber (to receive signals) in fluidic communication with the metering channel, wherein the dilution chamber is configured to store a diluent and comprises a port engaging pressure means transferring the diluent from the dilution chamber into the metering channel.	US6368275B1 CLAIM 14. A medical diagnostic ultrasound system for observing a physiological property of a body, the system comprising: a transducer operable to transmit energy into the body; a plurality of micro-instrument particles having an observable property responsive to the ultrasonic energy, the observable property varying as a function of the physiological property of the body; and a receive beamformer operable to receive signals (dilution chamber, reagent chamber) responsive to the micro-instrument particles along a scan line.
US10533994B2 CLAIM 9. The system of claim 8 , wherein the assay assembly comprises a reagent chamber (to receive signals) in fluidic communication with the reaction site, wherein the reagent chamber is configured to store an assay reagent.	US6368275B1 CLAIM 14. A medical diagnostic ultrasound system for observing a physiological property of a body, the system comprising: a transducer operable to transmit energy into the body; a plurality of micro-instrument particles having an observable property responsive to the ultrasonic energy, the observable property varying as a function of the physiological property of the body; and a receive beamformer operable to receive signals (dilution chamber, reagent chamber) responsive to the micro-instrument particles along a scan line.
US10533994B2 CLAIM 10. The system of claim 1 , wherein the reaction site of the assay assembly is in fluidic communication with the sample collection unit, the reaction site containing a reactant that reacts with the analyte to yield a signal indicative of the presence of the analyte; and the assay assembly further comprises: a reagent chamber (to receive signals) in fluidic communication with the reaction site, wherein the reagent chamber is configured to store an assay reagent; a fluidic channel connecting the reagent chamber with the reaction site; and an actuatable valve assembly configured to control the flow of reagent through the fluidic channel, wherein the valve assembly comprises a sealing element and actuator element, wherein the channel comprises first and second locations, wherein the sealing element positioned in the first location obstructs the flow of fluid through the channel and the sealing element positioned in the second location allows the flow of fluid through the channel, and wherein the actuator element is adapted to move the sealing element from the first location to the second location.	US6368275B1 CLAIM 14. A medical diagnostic ultrasound system for observing a physiological property of a body, the system comprising: a transducer operable to transmit energy into the body; a plurality of micro-instrument particles having an observable property responsive to the ultrasonic energy, the observable property varying as a function of the physiological property of the body; and a receive beamformer operable to receive signals (dilution chamber, reagent chamber) responsive to the micro-instrument particles along a scan line.

US10533994B2 Filed: 2006-03-24     Issued: 2020-01-14 Systems and methods of sample processing and fluid control in a fluidic system (Original Assignee) Theranos IP Co LLC     (Current Assignee) Theranos IP Co LLC Elizabeth A. Holmes, Shaunak Roy, Ian Gibbons, Shize Daniel Qi, Edmond Ku, Chris Todd, Melissa Takahashi, Bruce Johnson, Jeff Fenton, Keith Moravick, Uwe Springborn, Anthony Delacruz

US6403338B1 Filed: 2000-06-27     Issued: 2002-06-11 Microfluidic systems and methods of genotyping (Original Assignee) Caliper Life Sciences Inc     (Current Assignee) Caliper Life Sciences Inc Michael Knapp, John Wallace Parce, Luc J. Bousse, Anne R. Kopf-Sill

US10533994B2 CLAIM 1. A system for detecting the presence or absence of an analyte in a bodily fluid sample obtained from a subject, comprising: a cartridge, comprising: a sample collection unit, comprising: a sample collection well configured to receive a portion of the sample; a metering channel in fluid communication (fluid communication) with the sample collection well and configured such that the sample flows from the sample collection well into the metering channel; and a metering element comprising a mechanically movable portion configured to be movable from an open position that permits fluid communication between the sample collection well and the metering channel to a closed position that does not provide fluid communication between the sample collection well, thereby isolating a specific volume of the sample in the metering channel; a lysing assembly configured to lyse cells present in the sample; and an assay assembly comprising a reaction site containing a reactant able to react with the analyte to yield a detectable signal indicative of the presence or absence of the analyte; and a reader assembly comprising: a detection assembly configured to detect the signal; and a communication assembly configured to receive an assay protocol in response to receiving an identity of the cartridge from an external device, the external device being separate from the reader assembly, the communication assembly further configured to transmit the signal to the external device.

US6403338B1 CLAIM 27. A system for determining a sequence of nucleotides in a target nucleic acid sequence, comprising: a microfluidic device comprising at least a first analysis channel and at least a first probe introduction channel, wherein the analysis channel intersects and is in fluid communication (fluid communication) with the probe introduction channel; a source of the target nucleic acid sequence in fluid communication with the analysis channel; a plurality of separate sources of oligonucleotide probes in fluid communication with the probe introduction channel, each of the plurality of separate sources containing an oligonucleotide probe having a different nucleotide sequence of length n; a sampling system for separately transporting a volume of each of the oligonucleotide probes from the sources of oligonucleotide probes to the probe introduction channel and injecting each of the oligonucleotide probes into the analysis channel to contact the target nucleic acid sequence; and a detection system for identifying whether each oligonucleotide probe hybridizes with the target nucleic acid sequence.

US10533994B2 Filed: 2006-03-24     Issued: 2020-01-14 Systems and methods of sample processing and fluid control in a fluidic system (Original Assignee) Theranos IP Co LLC     (Current Assignee) Theranos IP Co LLC Elizabeth A. Holmes, Shaunak Roy, Ian Gibbons, Shize Daniel Qi, Edmond Ku, Chris Todd, Melissa Takahashi, Bruce Johnson, Jeff Fenton, Keith Moravick, Uwe Springborn, Anthony Delacruz

US5472603A Filed: 1993-09-20     Issued: 1995-12-05 Analytical rotor with dye mixing chamber (Original Assignee) Abaxis Inc     (Current Assignee) Abaxis Inc Carol T. Schembri

US10533994B2 CLAIM 4. The system of claim 2 , wherein the sample collection unit further comprises: a dilution chamber in fluidic communication with the metering channel, wherein the dilution chamber is configured to store a diluent and comprises a port engaging pressure means (cross sectional area) transferring the diluent from the dilution chamber into the metering channel.

US5472603A CLAIM 1. An analytical rotor comprising: a delivery chamber containing a fluid; a holding chamber positioned radially outward from the delivery chamber, the holding chamber being connected to the delivery chamber through an entry channel, whereby the fluid flows from the delivery chamber to the holding chamber as the rotor is spinning at a first rotational speed; a receiving chamber positioned radially outward from the holding chamber and being connected to the holding chamber through an exit duct; and a capillary passage connecting the exit duct to the receiving chamber, the capillary passage having a cross sectional area (port engaging pressure means) less than the cross sectional area of the entry channel which prevents flow of fluid from the holding chamber to the receiving chamber when the rotor is spinning at the first rotational speed and allows flow at a second higher rotational speed.

US10533994B2 Filed: 2006-03-24     Issued: 2020-01-14 Systems and methods of sample processing and fluid control in a fluidic system (Original Assignee) Theranos IP Co LLC     (Current Assignee) Theranos IP Co LLC Elizabeth A. Holmes, Shaunak Roy, Ian Gibbons, Shize Daniel Qi, Edmond Ku, Chris Todd, Melissa Takahashi, Bruce Johnson, Jeff Fenton, Keith Moravick, Uwe Springborn, Anthony Delacruz

US20020187074A1 Filed: 2002-06-07     Issued: 2002-12-12 Microfluidic analytical devices and methods (Original Assignee) Nanostream Inc     (Current Assignee) Agilent Technologies Inc Stephen O'Connor, Christoph Karp, Marci Pezzuto, Courtney Coyne, Steven Hobbs, Eugene Dantsker

US10533994B2 CLAIM 1. A system for detecting the presence or absence of an analyte in a bodily fluid sample obtained from a subject, comprising: a cartridge, comprising: a sample collection unit, comprising: a sample collection well configured to receive a portion of the sample; a metering channel in fluid communication (fluid communication) with the sample collection well and configured such that the sample flows from the sample collection well into the metering channel; and a metering element comprising a mechanically movable portion configured to be movable from an open position that permits fluid communication between the sample collection well and the metering channel to a closed position that does not provide fluid communication between the sample collection well, thereby isolating a specific volume of the sample in the metering channel; a lysing assembly configured to lyse cells present in the sample; and an assay assembly comprising a reaction site containing a reactant able to react with the analyte to yield a detectable signal indicative of the presence or absence of the analyte; and a reader assembly comprising: a detection assembly configured to detect the signal; and a communication assembly configured to receive an assay protocol in response to receiving an identity of the cartridge from an external device, the external device being separate from the reader assembly, the communication assembly further configured to transmit the signal to the external device.

US20020187074A1 CLAIM 1 . A microfluidic device for passively mixing at least two fluids for analysis, the device comprising a plurality of device layers defining: a first fluidic input; a first junction or manifold region in fluid communication (fluid communication) with the first fluidic input; a first plurality of unequal impedance branch channels in fluid communication with the first junction or manifold region; a second fluidic input; a second junction or manifold region in fluid communication with the second fluidic input; a second plurality of unequal impedance branch channels in fluid communication with the second junction or manifold region; a plurality of mixer regions in fluid communication with the first plurality of unequal impedance branch channels and the second plurality of unequal impedance branch channels, wherein the plurality of mixer regions, the first plurality of unequal impedance branch channels, and the second plurality of unequal impedance branch channels are disposed within the plurality of device layers so as to permit simultaneous and combination of a first fluid and a second fluid in a plurality of different predetermined mixing ratios; and a detection region in fluid communication with the plurality of mixer regions.

US10533994B2 Filed: 2006-03-24     Issued: 2020-01-14 Systems and methods of sample processing and fluid control in a fluidic system (Original Assignee) Theranos IP Co LLC     (Current Assignee) Theranos IP Co LLC Elizabeth A. Holmes, Shaunak Roy, Ian Gibbons, Shize Daniel Qi, Edmond Ku, Chris Todd, Melissa Takahashi, Bruce Johnson, Jeff Fenton, Keith Moravick, Uwe Springborn, Anthony Delacruz

US20050106713A1 Filed: 2004-09-02     Issued: 2005-05-19 Personal diagnostic devices and related methods (Original Assignee) LIFE PATCH INTERNATIONAL Inc     (Current Assignee) LIFE PATCH INTERNATIONAL Inc Brigitte Phan, Andrew Pal, Ramoncito Valencia, Donald Bollella

US10533994B2 CLAIM 1. A system for detecting the presence or absence of an analyte in a bodily fluid sample obtained from a subject, comprising: a cartridge, comprising: a sample collection unit, comprising: a sample collection well configured to receive a portion of the sample; a metering channel in fluid communication (fluid communication) with the sample collection well and configured such that the sample flows from the sample collection well into the metering channel; and a metering element comprising a mechanically movable portion configured to be movable from an open position that permits fluid communication between the sample collection well and the metering channel to a closed position that does not provide fluid communication between the sample collection well, thereby isolating a specific volume of the sample in the metering channel; a lysing assembly configured to lyse cells present in the sample; and an assay assembly comprising a reaction site containing a reactant able to react with the analyte to yield a detectable signal indicative of the presence or absence of the analyte; and a reader assembly comprising: a detection assembly configured to detect the signal; and a communication assembly configured to receive an assay protocol in response to receiving an identity of the cartridge from an external device, the external device being separate from the reader assembly, the communication assembly further configured to transmit the signal to the external device.

US20050106713A1 CLAIM 1 . A personal diagnostic device, comprising: a sample acquisition layer for obtaining a fluid sample from a user; a fluid sample layer for processing said fluid sample obtained from said user, said fluid sample layer being in fluid communication (fluid communication) with said sample acquisition layer; means for detecting diagnostic results derived from said processing of said fluid sample; and means for displaying said diagnostic results.

US10533994B2 Filed: 2006-03-24     Issued: 2020-01-14 Systems and methods of sample processing and fluid control in a fluidic system (Original Assignee) Theranos IP Co LLC     (Current Assignee) Theranos IP Co LLC Elizabeth A. Holmes, Shaunak Roy, Ian Gibbons, Shize Daniel Qi, Edmond Ku, Chris Todd, Melissa Takahashi, Bruce Johnson, Jeff Fenton, Keith Moravick, Uwe Springborn, Anthony Delacruz	US6893879B2 Filed: 2001-11-07     Issued: 2005-05-17 Method for separating analyte from a sample (Original Assignee) Cepheid Inc     (Current Assignee) Cepheid Inc Kurt E. Petersen, William A. McMillan, Lee A. Christel, Ronald Chang, Farzad Pourahmadi, Jesus Ching, Gregory T. A. Kovacs, M. Allen Northrup
US10533994B2 CLAIM 9. The system of claim 8 , wherein the assay assembly comprises a reagent chamber (reagent chamber) in fluidic communication with the reaction site, wherein the reagent chamber is configured to store an assay reagent.	US6893879B2 CLAIM 3. The method of claim 1 , wherein the cartridge further includes a reagent chamber (reagent chamber) containing dried or lyophilized reagents, and the method further comprises the step of mixing the eluted analyte with the reagents in the reagent chamber prior to forcing the analyte to flow into the reaction chamber.
US10533994B2 CLAIM 10. The system of claim 1 , wherein the reaction site of the assay assembly is in fluidic communication with the sample collection unit, the reaction site containing a reactant that reacts with the analyte to yield a signal indicative of the presence of the analyte; and the assay assembly further comprises: a reagent chamber (reagent chamber) in fluidic communication with the reaction site, wherein the reagent chamber is configured to store an assay reagent; a fluidic channel connecting the reagent chamber with the reaction site; and an actuatable valve assembly configured to control the flow of reagent through the fluidic channel, wherein the valve assembly comprises a sealing element and actuator element, wherein the channel comprises first and second locations, wherein the sealing element positioned in the first location obstructs the flow of fluid through the channel and the sealing element positioned in the second location allows the flow of fluid through the channel, and wherein the actuator element is adapted to move the sealing element from the first location to the second location.	US6893879B2 CLAIM 3. The method of claim 1 , wherein the cartridge further includes a reagent chamber (reagent chamber) containing dried or lyophilized reagents, and the method further comprises the step of mixing the eluted analyte with the reagents in the reagent chamber prior to forcing the analyte to flow into the reaction chamber.

US10533994B2 Filed: 2006-03-24     Issued: 2020-01-14 Systems and methods of sample processing and fluid control in a fluidic system (Original Assignee) Theranos IP Co LLC     (Current Assignee) Theranos IP Co LLC Elizabeth A. Holmes, Shaunak Roy, Ian Gibbons, Shize Daniel Qi, Edmond Ku, Chris Todd, Melissa Takahashi, Bruce Johnson, Jeff Fenton, Keith Moravick, Uwe Springborn, Anthony Delacruz	US20020042125A1 Filed: 2001-11-07     Issued: 2002-04-11 Method for separating analyte from a sample (Original Assignee) Cepheid Inc     (Current Assignee) Cepheid Inc Kurt Petersen, William McMillan, Lee Christel, Ronald Chang, Farzad Pourahmadi, Jesus Ching, Gregory Kovacs, M. Northrup
US10533994B2 CLAIM 1. A system for detecting the presence or absence of an analyte in a bodily fluid sample (second flow path) obtained from a subject, comprising: a cartridge, comprising: a sample collection unit, comprising: a sample collection well configured to receive a portion of the sample; a metering channel in fluid communication (fluid communication) with the sample collection well and configured such that the sample flows from the sample collection well into the metering channel; and a metering element comprising a mechanically movable portion configured to be movable from an open position that permits fluid communication between the sample collection well and the metering channel to a closed position that does not provide fluid communication between the sample collection well, thereby isolating a specific volume of the sample in the metering channel; a lysing assembly configured to lyse cells present in the sample; and an assay assembly comprising a reaction site containing a reactant able to react with the analyte to yield a detectable signal indicative of the presence or absence of the analyte; and a reader assembly comprising: a detection assembly configured to detect the signal; and a communication assembly configured to receive an assay protocol in response to receiving an identity of the cartridge from an external device, the external device being separate from the reader assembly, the communication assembly further configured to transmit the signal to the external device.	US20020042125A1 CLAIM 1 . A method for separating an analyte from a fluid sample and for concentrating the analyte into a volume of elution fluid, the method comprising the steps of: a) introducing the sample into a cartridge having: i) a sample port; ii) a first flow path extending from the sample port; iii) an extraction chamber in the first flow path, wherein the extraction chamber contains at least one solid support for capturing the analyte from the sample; and iv) a second flow path (bodily fluid sample) for eluting the analyte from the extraction chamber, wherein the second flow path passes through the extraction chamber and diverges from the first flow path after passing through the extraction chamber; b) forcing the sample to flow through the first flow path, thereby capturing the analyte with the solid support as the sample flows through the extraction chamber, wherein the ratio of the volume of sample forced to flow through the extraction chamber to the volume capacity of the extraction chamber is at least 2:1, and wherein the volume of sample forced to flow through the extraction chamber is at least 0.1 ml; and c) forcing an elution fluid to flow through the second flow path, thereby releasing the captured analyte from the solid support into the elution fluid. US20020042125A1 CLAIM 16 . The method of claim 1 , wherein the cartridge further includes: a lysing region in the first flow path upstream of the extraction chamber; a waste chamber in fluid communication (fluid communication) with the extraction chamber via the first flow path; and a reaction chamber in fluid communication with the extraction chamber via the second flow path; and wherein the method further comprises the steps of: lysing sample components in the lysing region prior to forcing the sample to flow through the extraction chamber; forcing the sample to flow into the waste chamber after the sample flows through the extraction chamber; forcing the eluted analyte to flow into the reaction chamber; and amplififying or detecting the analyte in the reaction chamber.
US10533994B2 CLAIM 9. The system of claim 8 , wherein the assay assembly comprises a reagent chamber (reagent chamber) in fluidic communication with the reaction site, wherein the reagent chamber is configured to store an assay reagent.	US20020042125A1 CLAIM 14 . The method of claim 1 , wherein the second flow path leads to a reagent chamber (reagent chamber) , and the method further comprises the step of mixing the eluted analyte with a reagent in the reagent chamber.
US10533994B2 CLAIM 10. The system of claim 1 , wherein the reaction site of the assay assembly is in fluidic communication with the sample collection unit, the reaction site containing a reactant that reacts with the analyte to yield a signal indicative of the presence of the analyte; and the assay assembly further comprises: a reagent chamber (reagent chamber) in fluidic communication with the reaction site, wherein the reagent chamber is configured to store an assay reagent; a fluidic channel connecting the reagent chamber with the reaction site; and an actuatable valve assembly configured to control the flow of reagent through the fluidic channel, wherein the valve assembly comprises a sealing element and actuator element, wherein the channel comprises first and second locations, wherein the sealing element positioned in the first location obstructs the flow of fluid through the channel and the sealing element positioned in the second location allows the flow of fluid through the channel, and wherein the actuator element is adapted to move the sealing element from the first location to the second location.	US20020042125A1 CLAIM 14 . The method of claim 1 , wherein the second flow path leads to a reagent chamber (reagent chamber) , and the method further comprises the step of mixing the eluted analyte with a reagent in the reagent chamber.

US10533994B2 Filed: 2006-03-24     Issued: 2020-01-14 Systems and methods of sample processing and fluid control in a fluidic system (Original Assignee) Theranos IP Co LLC     (Current Assignee) Theranos IP Co LLC Elizabeth A. Holmes, Shaunak Roy, Ian Gibbons, Shize Daniel Qi, Edmond Ku, Chris Todd, Melissa Takahashi, Bruce Johnson, Jeff Fenton, Keith Moravick, Uwe Springborn, Anthony Delacruz	US20040086872A1 Filed: 2002-10-31     Issued: 2004-05-06 Microfluidic system for analysis of nucleic acids (Original Assignee) Hewlett Packard Development Co LP     (Current Assignee) Hewlett Packard Development Co LP Winthrop Childers, David Tyvoll
US10533994B2 CLAIM 9. The system of claim 8 , wherein the assay assembly comprises a reagent chamber (reagent chamber) in fluidic communication with the reaction site, wherein the reagent chamber is configured to store an assay reagent.	US20040086872A1 CLAIM 37 . A cartridge for analysis of a nucleic acid in a biological sample, comprising: a fluid-handling device including, a biological-sample input chamber, a reagent chamber (reagent chamber) , and a pre-processing chamber fluidically connected to the biological-sample input chamber and the reagent chamber and configured to at least partially separate the nucleic acid from a waste portion of the sample; and an assay device including a substrate and electronics formed on the substrate, the assay device defining an assay chamber that is fluidically coupled to the pre-processing chamber, the electronics being coupled to the assay chamber for performing an assay on the separated nucleic acid.
US10533994B2 CLAIM 10. The system of claim 1 , wherein the reaction site of the assay assembly is in fluidic communication with the sample collection unit, the reaction site containing a reactant that reacts with the analyte to yield a signal indicative of the presence of the analyte; and the assay assembly further comprises: a reagent chamber (reagent chamber) in fluidic communication with the reaction site, wherein the reagent chamber is configured to store an assay reagent; a fluidic channel connecting the reagent chamber with the reaction site; and an actuatable valve assembly configured to control the flow of reagent through the fluidic channel, wherein the valve assembly comprises a sealing element and actuator element, wherein the channel comprises first and second locations, wherein the sealing element positioned in the first location obstructs the flow of fluid through the channel and the sealing element positioned in the second location allows the flow of fluid through the channel, and wherein the actuator element is adapted to move the sealing element from the first location to the second location.	US20040086872A1 CLAIM 37 . A cartridge for analysis of a nucleic acid in a biological sample, comprising: a fluid-handling device including, a biological-sample input chamber, a reagent chamber (reagent chamber) , and a pre-processing chamber fluidically connected to the biological-sample input chamber and the reagent chamber and configured to at least partially separate the nucleic acid from a waste portion of the sample; and an assay device including a substrate and electronics formed on the substrate, the assay device defining an assay chamber that is fluidically coupled to the pre-processing chamber, the electronics being coupled to the assay chamber for performing an assay on the separated nucleic acid.

US10533994B2 Filed: 2006-03-24     Issued: 2020-01-14 Systems and methods of sample processing and fluid control in a fluidic system (Original Assignee) Theranos IP Co LLC     (Current Assignee) Theranos IP Co LLC Elizabeth A. Holmes, Shaunak Roy, Ian Gibbons, Shize Daniel Qi, Edmond Ku, Chris Todd, Melissa Takahashi, Bruce Johnson, Jeff Fenton, Keith Moravick, Uwe Springborn, Anthony Delacruz	US6156181A Filed: 1998-10-26     Issued: 2000-12-05 Controlled fluid transport microfabricated polymeric substrates (Original Assignee) Caliper Technologies Corp     (Current Assignee) Caliper Life Sciences Inc John Wallace Parce, Michael R. Knapp, Calvin Y. H. Chow, Luc Bousse
US10533994B2 CLAIM 1. A system for detecting the presence or absence of an analyte in a bodily fluid sample obtained from a subject, comprising: a cartridge, comprising: a sample collection unit, comprising: a sample collection well configured to receive a portion of the sample; a metering channel in fluid communication (fluid communication) with the sample collection well and configured such that the sample flows from the sample collection well into the metering channel; and a metering element comprising a mechanically movable portion configured to be movable from an open position that permits fluid communication between the sample collection well and the metering channel to a closed position that does not provide fluid communication between the sample collection well, thereby isolating a specific volume of the sample in the metering channel; a lysing assembly configured to lyse cells present in the sample; and an assay assembly comprising a reaction site containing a reactant able to react with the analyte to yield a detectable signal indicative of the presence or absence of the analyte; and a reader assembly comprising: a detection assembly configured to detect the signal; and a communication assembly configured to receive an assay protocol in response to receiving an identity of the cartridge from an external device, the external device being separate from the reader assembly, the communication assembly further configured to transmit the signal to the external device.	US6156181A CLAIM 17. The microfluidic device of claim 1, the body structure comprising at least two intersecting microchannels fabricated therein, wherein each of the at least two intersecting microchannels comprises a surface having a zeta potential associated therewith, which zeta potential is capable of supporting an electroosmotic mobility of a fluid of at least 2×10 -5 cm 2 v -1 s -1 , wherein said fluid is a sodium borate buffer having an ionic strength of between about 1 and about 10 mM, and a pH of from about 7 to 9, the body structure also comprising at least first, second, third and fourth ports in fluid communication (fluid communication) with the at least two microchannels.
US10533994B2 CLAIM 14. The system of claim 10 , wherein the actuator element comprises a sealing member (fluid control system) such that when the actuator element moves the sealing element the sealing member forms a substantially air tight seal such that the fluid can only flow through the channel.	US6156181A CLAIM 19. The microfluidic device of claim 1, further comprising one or more of: a sampling system for introducing fluids into the at least one microchannel; a detection system for detecting analytes in the microchannel; a data storage system; a fluid control system (sealing member) for controlling fluid transport and direction in the at least one microchannel; a temperature detector for detecting the temperature of a portion of the body structure; and, a current detector for detecting current in the at least one microchannel.
US10533994B2 CLAIM 15. The system of claim 14 wherein the actuator element is substantially pin shaped and the sealing member (fluid control system) is an O-ring adapted to be placed around the actuator element.	US6156181A CLAIM 19. The microfluidic device of claim 1, further comprising one or more of: a sampling system for introducing fluids into the at least one microchannel; a detection system for detecting analytes in the microchannel; a data storage system; a fluid control system (sealing member) for controlling fluid transport and direction in the at least one microchannel; a temperature detector for detecting the temperature of a portion of the body structure; and, a current detector for detecting current in the at least one microchannel.

US10533994B2 Filed: 2006-03-24     Issued: 2020-01-14 Systems and methods of sample processing and fluid control in a fluidic system (Original Assignee) Theranos IP Co LLC     (Current Assignee) Theranos IP Co LLC Elizabeth A. Holmes, Shaunak Roy, Ian Gibbons, Shize Daniel Qi, Edmond Ku, Chris Todd, Melissa Takahashi, Bruce Johnson, Jeff Fenton, Keith Moravick, Uwe Springborn, Anthony Delacruz

US20030208133A1 Filed: 2002-12-31     Issued: 2003-11-06 Breath ketone analyzer (Original Assignee) Healthetech Inc     (Current Assignee) Healthetech Inc James Mault

US10533994B2 CLAIM 1. A system for detecting the presence or absence of an analyte in a bodily fluid sample obtained from a subject, comprising: a cartridge, comprising: a sample collection unit, comprising: a sample collection well configured to receive a portion of the sample; a metering channel in fluid communication (fluid communication) with the sample collection well and configured such that the sample flows from the sample collection well into the metering channel; and a metering element comprising a mechanically movable portion configured to be movable from an open position that permits fluid communication between the sample collection well and the metering channel to a closed position that does not provide fluid communication between the sample collection well, thereby isolating a specific volume of the sample in the metering channel; a lysing assembly configured to lyse cells present in the sample; and an assay assembly comprising a reaction site containing a reactant able to react with the analyte to yield a detectable signal indicative of the presence or absence of the analyte; and a reader assembly comprising: a detection assembly configured to detect the signal; and a communication assembly configured to receive an assay protocol in response to receiving an identity of the cartridge from an external device, the external device being separate from the reader assembly, the communication assembly further configured to transmit the signal to the external device.

US20030208133A1 CLAIM 7 . A respiratory analyzer, comprising: a flow path operable to receive and pass exhaled gases, the flow path having a first end in fluid communication (fluid communication) with a respiratory connector and a second end in fluid communication with a source and sink for respiratory gases, the respiratory connector configured to be supported in contact with a subject so as to pass exhaled gases as the subject breathes, the flow path comprising a flow tube through which the exhaled gases pass, and a chamber disposed between the flow tube and the first end, the chamber being a concentric chamber surrounding one end of the flow tube; and a ketone sensor, providing a ketone signal correlated with a ketone concentration in exhaled breath passing through the flow path.

US10533994B2 Filed: 2006-03-24     Issued: 2020-01-14 Systems and methods of sample processing and fluid control in a fluidic system (Original Assignee) Theranos IP Co LLC     (Current Assignee) Theranos IP Co LLC Elizabeth A. Holmes, Shaunak Roy, Ian Gibbons, Shize Daniel Qi, Edmond Ku, Chris Todd, Melissa Takahashi, Bruce Johnson, Jeff Fenton, Keith Moravick, Uwe Springborn, Anthony Delacruz	US20040109793A1 Filed: 2003-08-07     Issued: 2004-06-10 Three-dimensional microfluidics incorporating passive fluid control structures (Original Assignee) Biomicro Systems Inc     (Current Assignee) Biomicro Systems Inc Michael McNeely, Mark Spute, Nils Adey
US10533994B2 CLAIM 1. A system for detecting the presence or absence of an analyte in a bodily fluid sample obtained from a subject, comprising: a cartridge, comprising: a sample collection unit, comprising: a sample collection well configured to receive a portion of the sample; a metering channel in fluid communication (providing fluid communication) with the sample collection well and configured such that the sample flows from the sample collection well into the metering channel; and a metering element comprising a mechanically movable portion configured to be movable from an open position (said second side, said first side) that permits fluid communication between the sample collection well and the metering channel to a closed position that does not provide fluid communication between the sample collection well, thereby isolating a specific volume of the sample in the metering channel; a lysing assembly configured to lyse cells present in the sample; and an assay assembly comprising a reaction site containing a reactant able to react with the analyte to yield a detectable signal indicative of the presence or absence of the analyte; and a reader assembly comprising: a detection assembly configured to detect the signal; and a communication assembly configured to receive an assay protocol in response to receiving an identity of the cartridge from an external device, the external device being separate from the reader assembly, the communication assembly further configured to transmit the signal to the external device.	US20040109793A1 CLAIM 1 . A multi-layered microfluidic device comprising: a. a plurality of substantially planar layers assembled together in sealing relationship; b. microfluidic structures lying in at least two planes corresponding to at least two said planar layers of said microfluidic device; and c. at least one microfluidic structure passing through one or more adjacent planar layers and providing fluid communication (fluid communication) between microfluidic structures in different planes; wherein said microfluidic structures comprise one or more channels, wells, dividers, mixers, valves, air ducts, or air vents; and wherein at least one of said plurality of planar layers has a hydrophobic surface. US20040109793A1 CLAIM 70 . A three-dimensional microfluid structure adapted for performing serial dilution of a sample, comprising: a. a plurality of substantially planar layers assembled in sealing relationship; a mixing circuit; b. a first mixing circuit formed within said three-dimensional structure comprising: i. a first inlet channel; ii. a branch point downstream of said first channel at which said first inlet channel branches into a first main channel and a first side channel; iii. a first passive valve located downstream of said branch point on said main channel; iv. a first junction downstream of said branch point where said first side (open position, pressure means) channel rejoins said first main channel; v. a second passive valve located on said first side channel just upstream of said first junction, wherein said second passive valve is stronger than said first passive valve; and vi. a first outlet channel downstream of said junction; c. at least one additional mixing circuit formed within said three-dimensional structure downstream of said first mixing circuit, comprising: i. a second inlet channel downstream of said first outlet channel; ii. a second branch point downstream of said second inlet channel at which said second inlet channel branches into a second main channel and a second side channel; iii. a third passive valve located downstream of said second branch point on said second main channel; iv. a second junction downstream of said branch second point where said second side (open position, pressure means) channel rejoins said second main channel; v. a fourth passive valve located on said second side channel just upstream of said second junction, wherein said fourth passive valve is stronger than said third passive valve; and vi. a second outlet channel downstream of said second junction.
US10533994B2 CLAIM 3. The system of claim 2 , wherein the pin is configured to be movable from an open position (said second side, said first side) to a closed position, wherein the pin in the closed position blocks the metering channel.	US20040109793A1 CLAIM 70 . A three-dimensional microfluid structure adapted for performing serial dilution of a sample, comprising: a. a plurality of substantially planar layers assembled in sealing relationship; a mixing circuit; b. a first mixing circuit formed within said three-dimensional structure comprising: i. a first inlet channel; ii. a branch point downstream of said first channel at which said first inlet channel branches into a first main channel and a first side channel; iii. a first passive valve located downstream of said branch point on said main channel; iv. a first junction downstream of said branch point where said first side (open position, pressure means) channel rejoins said first main channel; v. a second passive valve located on said first side channel just upstream of said first junction, wherein said second passive valve is stronger than said first passive valve; and vi. a first outlet channel downstream of said junction; c. at least one additional mixing circuit formed within said three-dimensional structure downstream of said first mixing circuit, comprising: i. a second inlet channel downstream of said first outlet channel; ii. a second branch point downstream of said second inlet channel at which said second inlet channel branches into a second main channel and a second side channel; iii. a third passive valve located downstream of said second branch point on said second main channel; iv. a second junction downstream of said branch second point where said second side (open position, pressure means) channel rejoins said second main channel; v. a fourth passive valve located on said second side channel just upstream of said second junction, wherein said fourth passive valve is stronger than said third passive valve; and vi. a second outlet channel downstream of said second junction.
US10533994B2 CLAIM 4. The system of claim 2 , wherein the sample collection unit further comprises: a dilution chamber in fluidic communication with the metering channel, wherein the dilution chamber is configured to store a diluent and comprises a port engaging pressure means (said second side, said first side) (cross sectional area) transferring the diluent from the dilution chamber into the metering channel.	US20040109793A1 CLAIM 70 . A three-dimensional microfluid structure adapted for performing serial dilution of a sample, comprising: a. a plurality of substantially planar layers assembled in sealing relationship; a mixing circuit; b. a first mixing circuit formed within said three-dimensional structure comprising: i. a first inlet channel; ii. a branch point downstream of said first channel at which said first inlet channel branches into a first main channel and a first side channel; iii. a first passive valve located downstream of said branch point on said main channel; iv. a first junction downstream of said branch point where said first side (open position, pressure means) channel rejoins said first main channel; v. a second passive valve located on said first side channel just upstream of said first junction, wherein said second passive valve is stronger than said first passive valve; and vi. a first outlet channel downstream of said junction; c. at least one additional mixing circuit formed within said three-dimensional structure downstream of said first mixing circuit, comprising: i. a second inlet channel downstream of said first outlet channel; ii. a second branch point downstream of said second inlet channel at which said second inlet channel branches into a second main channel and a second side channel; iii. a third passive valve located downstream of said second branch point on said second main channel; iv. a second junction downstream of said branch second point where said second side (open position, pressure means) channel rejoins said second main channel; v. a fourth passive valve located on said second side channel just upstream of said second junction, wherein said fourth passive valve is stronger than said third passive valve; and vi. a second outlet channel downstream of said second junction. US20040109793A1 CLAIM 72 . A three-dimensional microfluidic branching circuit comprising: a. a plurality of substantially planar layers assembled in sealing relationship; b. an inlet channel passing through at least a first layer; c. a primary branch channel formed in a second layer adjacent said first layer, wherein said inlet channel intersects said primary branch channel at its central region; d. two primary via channels passing through a third layer adjacent said second layer, wherein one of said primary via channels intersects said primary branch channel at each of its ends; e. two secondary branch channels formed in a fourth layer adjacent said third layer, wherein each of said via channels intersects one of said secondary branch channels at its central region; f. four secondary via channels passing through a fifth layer adjacent said fourth layer, wherein one of said secondary via channels intersects each said secondary branch channel at each of its ends; wherein said two primary via channels have smaller cross sectional area (port engaging pressure means) s than said primary branch channel, and wherein said four secondary via channels have smaller cross-sectional areas than said primary via channels.
US10533994B2 CLAIM 14. The system of claim 10 , wherein the actuator element comprises a sealing member such that when the actuator element moves the sealing element the sealing member forms a substantially air tight seal (tight seal) such that the fluid can only flow through the channel.

US10533994B2 Filed: 2006-03-24     Issued: 2020-01-14 Systems and methods of sample processing and fluid control in a fluidic system (Original Assignee) Theranos IP Co LLC     (Current Assignee) Theranos IP Co LLC Elizabeth A. Holmes, Shaunak Roy, Ian Gibbons, Shize Daniel Qi, Edmond Ku, Chris Todd, Melissa Takahashi, Bruce Johnson, Jeff Fenton, Keith Moravick, Uwe Springborn, Anthony Delacruz	US20050100937A1 Filed: 2004-09-10     Issued: 2005-05-12 Medical device for analyte monitoring and drug delivery (Original Assignee) Holmes Elizabeth A.     (Current Assignee) Theranos IP Co LLC Elizabeth Holmes
US10533994B2 CLAIM 1. A system for detecting the presence or absence of an analyte in a bodily fluid (therapeutic agent releasing device, obtaining physical parameter data, disease marker biological analyte, biometric recognition device, analyte interaction profile, microarray scanning device, bodily fluid) sample (therapeutic agent releasing device, obtaining physical parameter data, disease marker biological analyte, biometric recognition device, analyte interaction profile, microarray scanning device, bodily fluid) obtained from a subject, comprising: a cartridge, comprising: a sample collection unit, comprising: a sample collection well configured to receive a portion of the sample; a metering channel in fluid communication (fluid communication) with the sample collection well and configured such that the sample flows from the sample collection well into the metering channel; and a metering element comprising a mechanically movable portion configured to be movable from an open position that permits fluid communication between the sample collection well and the metering channel to a closed position that does not provide fluid communication between the sample collection well, thereby isolating a specific volume of the sample in the metering channel; a lysing assembly configured to lyse cells present in the sample; and an assay assembly comprising a reaction site containing a reactant able to react with the analyte to yield a detectable signal indicative of the presence or absence of the analyte; and a reader assembly comprising: a detection assembly configured to detect the signal; and a communication assembly configured to receive an assay protocol in response to receiving an identity of the cartridge from an external device, the external device being separate from the reader assembly, the communication assembly further configured to transmit the signal to the external device.	US20050100937A1 CLAIM 1 . A medical device comprising: a) a microarray comprising a bioactive agent capable of interacting with a disease marker biological analyte (bodily fluid sample, bodily fluid) ; b) at least one reservoir comprising at least one therapeutic agent and capable of releasing said at least one therapeutic agent from said medical device; c) a plurality of microchips comprising; i) a microarray scanning device (bodily fluid sample, bodily fluid) capable of obtaining physical parameter data (bodily fluid sample, bodily fluid) of an interaction between the disease marker biological analyte with said bioactive agent; ii) a biometric recognition device (bodily fluid sample, bodily fluid) capable of comparing said physical parameter data with an analyte interaction profile (bodily fluid sample, bodily fluid) ; iii) a therapeutic agent releasing device (bodily fluid sample, bodily fluid) capable of controlling release of said therapeutic agent from said reservoir; and iv) an interface device capable of facilitating communications between said microarray scanning device, said biometric recognition device and said therapeutic agent releasing device; d) an energy source to power the medical device. US20050100937A1 CLAIM 47 . The medical device of claim 1 , further comprising Personal Area Network transmitters directing the flow of bodily fluid (bodily fluid sample, bodily fluid) . US20050100937A1 CLAIM 48 . A medical device capable of detecting an analyte in a bodily fluid comprising: A) at least one microneedle capable of obtaining a sample of a bodily fluid; B) a first microchannel through which the sample flows which is in fluid communication (fluid communication) with the at least one microneedle; C) a second microchannel in fluid communication with the first microchannel; through which a buffer flows; wherein the second channel further comprises a microarray having at least one bioactive agent; D) a microarray scanning device to detect an interaction between the bioactive agent and the analyte in a bodily fluid; and E) an interface device capable of facilitating communications between said microarray scanning device and a biometric recognition device.
US10533994B2 CLAIM 17. The system of claim 10 , wherein the sample of bodily fluid (therapeutic agent releasing device, obtaining physical parameter data, disease marker biological analyte, biometric recognition device, analyte interaction profile, microarray scanning device, bodily fluid) is less than 50 μl.	US20050100937A1 CLAIM 1 . A medical device comprising: a) a microarray comprising a bioactive agent capable of interacting with a disease marker biological analyte (bodily fluid sample, bodily fluid) ; b) at least one reservoir comprising at least one therapeutic agent and capable of releasing said at least one therapeutic agent from said medical device; c) a plurality of microchips comprising; i) a microarray scanning device (bodily fluid sample, bodily fluid) capable of obtaining physical parameter data (bodily fluid sample, bodily fluid) of an interaction between the disease marker biological analyte with said bioactive agent; ii) a biometric recognition device (bodily fluid sample, bodily fluid) capable of comparing said physical parameter data with an analyte interaction profile (bodily fluid sample, bodily fluid) ; iii) a therapeutic agent releasing device (bodily fluid sample, bodily fluid) capable of controlling release of said therapeutic agent from said reservoir; and iv) an interface device capable of facilitating communications between said microarray scanning device, said biometric recognition device and said therapeutic agent releasing device; d) an energy source to power the medical device. US20050100937A1 CLAIM 47 . The medical device of claim 1 , further comprising Personal Area Network transmitters directing the flow of bodily fluid (bodily fluid sample, bodily fluid) .

US10533994B2 Filed: 2006-03-24     Issued: 2020-01-14 Systems and methods of sample processing and fluid control in a fluidic system (Original Assignee) Theranos IP Co LLC     (Current Assignee) Theranos IP Co LLC Elizabeth A. Holmes, Shaunak Roy, Ian Gibbons, Shize Daniel Qi, Edmond Ku, Chris Todd, Melissa Takahashi, Bruce Johnson, Jeff Fenton, Keith Moravick, Uwe Springborn, Anthony Delacruz	US5693233A Filed: 1995-12-04     Issued: 1997-12-02 Methods of transporting fluids within an analytical rotor (Original Assignee) Abaxis Inc     (Current Assignee) Abaxis Inc Carol T. Schembri
US10533994B2 CLAIM 4. The system of claim 2 , wherein the sample collection unit further comprises: a dilution chamber in fluidic communication with the metering channel, wherein the dilution chamber is configured to store a diluent and comprises a port engaging pressure means (cross sectional area) transferring the diluent from the dilution chamber into the metering channel.	US5693233A CLAIM 1. A method for delivering, in a centrifugal rotor, a fluid from a holding chamber to a receiving chamber positioned radially outward from the holding chamber, the holding chamber having an exit duct connected through a capillary passage to said receiving chamber, the method comprising the steps of: spinning the rotor at a first rotational speed, thereby transferring said fluid from a loading chamber positioned radially inward from said holding chamber through an entry channel into said holding chamber; and spinning the rotor at a second higher rotational speed, thereby transferring the fluid from the holding chamber to the receiving chamber through said exit duct and capillary passage, wherein said capillary passage has a cross sectional area (port engaging pressure means) less than the cross sectional area of the entry channel such that flow of fluid from the holding chamber to the receiving chamber is prevented at the first rotational speed and allowed at said second higher rotational speed.
US10533994B2 CLAIM 5. The system of claim 4 , wherein the sample collection unit further comprises a mixing chamber (mixing chamber) in fluidic communication with the metering channel, the mixing chamber being configured to mix the predetermined portion of the sample with the diluent to yield a diluted sample.	US5693233A CLAIM 2. The method of claim 1, wherein the holding chamber is a mixing chamber (mixing chamber) .

US10533994B2 Filed: 2006-03-24     Issued: 2020-01-14 Systems and methods of sample processing and fluid control in a fluidic system (Original Assignee) Theranos IP Co LLC     (Current Assignee) Theranos IP Co LLC Elizabeth A. Holmes, Shaunak Roy, Ian Gibbons, Shize Daniel Qi, Edmond Ku, Chris Todd, Melissa Takahashi, Bruce Johnson, Jeff Fenton, Keith Moravick, Uwe Springborn, Anthony Delacruz	US6245057B1 Filed: 1999-10-22     Issued: 2001-06-12 Device for treating malignant, tumorous tissue areas (Original Assignee) TDK-Micronas GmbH     (Current Assignee) TDK-Micronas GmbH Ulrich Sieben, Bernhard Wolf
US10533994B2 CLAIM 1. A system for detecting the presence or absence of an analyte in a bodily fluid (bodily fluid) sample obtained from a subject, comprising: a cartridge, comprising: a sample collection unit, comprising: a sample collection well configured to receive a portion of the sample; a metering channel in fluid communication with the sample collection well and configured such that the sample flows from the sample collection well into the metering channel; and a metering element comprising a mechanically movable portion configured to be movable from an open position that permits fluid communication between the sample collection well and the metering channel to a closed position that does not provide fluid communication between the sample collection well, thereby isolating a specific volume of the sample in the metering channel; a lysing assembly configured to lyse cells present in the sample; and an assay assembly comprising a reaction site containing a reactant able to react with the analyte to yield a detectable signal indicative of the presence or absence of the analyte; and a reader assembly comprising: a detection assembly configured to detect the signal; and a communication assembly configured to receive an assay protocol in response to receiving an identity of the cartridge from an external device, the external device being separate from the reader assembly, the communication assembly further configured to transmit the signal to the external device.	US6245057B1 CLAIM 1. A device ( 1 , 1 a , 1 b , 1 c , 1 d ) for treating malignant, tumorous tissue areas, comprising at least one measuring sensor ( 9 ) for determining chemical or physical signal patterns in an immediate vicinity of a tumorous tissue area, a control unit, and at least one treatment assembly having at least one active agent supply container ( 4 ), a dosing element with dosing control, and an active agent release element ( 6 ) for chemically influencing and/or treatment electrodes for physically influencing the tumorous tissue area to be treated, wherein the sensor(s)( 9 ), the active agent release element( 6 ) and/or the treatment electrodes ( 3 ) are connected to the control unit for controlling a physical and/or chemical treatment of the tumorous tissue area as a function of measured values of the tumor cells with continuous follow-up dosing of the active agent to be applied, wherein the device is constructed in a form of a swallowable capsule or a dragée and has a sheath ( 11 ) which at least covers the sensor(s)( 9 ), the sheath being removable at least over a certain area under the influence of bodily fluid (bodily fluid) , wherein the control unit and a sensor for detecting release parameters are designed with a threshold value switch for activating the active agent release element and/or the electrodes when a predetermined target value is exceeded, and wherein at least one heat resistor ( 18 ) is provided within the active agent supply container ( 4 ) for heating up and release of the active agent.
US10533994B2 CLAIM 17. The system of claim 10 , wherein the sample of bodily fluid (bodily fluid) is less than 50 μl.	US6245057B1 CLAIM 1. A device ( 1 , 1 a , 1 b , 1 c , 1 d ) for treating malignant, tumorous tissue areas, comprising at least one measuring sensor ( 9 ) for determining chemical or physical signal patterns in an immediate vicinity of a tumorous tissue area, a control unit, and at least one treatment assembly having at least one active agent supply container ( 4 ), a dosing element with dosing control, and an active agent release element ( 6 ) for chemically influencing and/or treatment electrodes for physically influencing the tumorous tissue area to be treated, wherein the sensor(s)( 9 ), the active agent release element( 6 ) and/or the treatment electrodes ( 3 ) are connected to the control unit for controlling a physical and/or chemical treatment of the tumorous tissue area as a function of measured values of the tumor cells with continuous follow-up dosing of the active agent to be applied, wherein the device is constructed in a form of a swallowable capsule or a dragée and has a sheath ( 11 ) which at least covers the sensor(s)( 9 ), the sheath being removable at least over a certain area under the influence of bodily fluid (bodily fluid) , wherein the control unit and a sensor for detecting release parameters are designed with a threshold value switch for activating the active agent release element and/or the electrodes when a predetermined target value is exceeded, and wherein at least one heat resistor ( 18 ) is provided within the active agent supply container ( 4 ) for heating up and release of the active agent.

US10533994B2 Filed: 2006-03-24     Issued: 2020-01-14 Systems and methods of sample processing and fluid control in a fluidic system (Original Assignee) Theranos IP Co LLC     (Current Assignee) Theranos IP Co LLC Elizabeth A. Holmes, Shaunak Roy, Ian Gibbons, Shize Daniel Qi, Edmond Ku, Chris Todd, Melissa Takahashi, Bruce Johnson, Jeff Fenton, Keith Moravick, Uwe Springborn, Anthony Delacruz	JP2003166910A Filed: 2001-11-30     Issued: 2003-06-13 送液機構及び該送液機構を備える分析装置 (Original Assignee) Asahi Kasei Corp; 旭化成株式会社      Keisuke Kamisaka, Koichiro Uchida, 圭介 上阪, 孝一郎 内田
US10533994B2 CLAIM 1. A system for detecting the presence or absence of an analyte in a bodily fluid sample obtained from a subject, comprising: a cartridge, comprising: a sample collection unit, comprising: a sample collection well configured to receive a portion of the sample; a metering channel in fluid communication with the sample collection well and configured such that the sample flows from the sample collection well into the metering channel; and a metering element comprising a mechanically movable portion configured to be movable from an open position (前記プランジャ) that permits fluid communication between the sample collection well and the metering channel to a closed position that does not provide fluid communication between the sample collection well, thereby isolating a specific volume of the sample in the metering channel; a lysing assembly configured to lyse cells present in the sample; and an assay assembly comprising a reaction site containing a reactant able to react with the analyte to yield a detectable signal indicative of the presence or absence of the analyte; and a reader assembly comprising: a detection assembly configured to detect the signal; and a communication assembly configured to receive an assay protocol in response to receiving an identity of the cartridge from an external device, the external device being separate from the reader assembly, the communication assembly further configured to transmit the signal to the external device.	JP2003166910A CLAIM 1 【特許請求の範囲】 【請求項１】 壁体に囲まれて形成された液体槽の容積 を変化させることによって、前記液体槽に満たされた液 体を前記液体槽に連結された流路に送る、又は、前記流 路若しくは前記流路に連結された別の液体槽に収納され た液体を前記液体槽に送る送液機構であって、 前記壁体の少なくとも一部が、前記液体槽の内部又は外 部に向かって突出するように変形可能な弾性を有する隔 壁で構成されていることを特徴とする送液機構。 【請求項２】 前記隔壁を押圧して又は引いて変形させ る隔壁変形手段を備えることを特徴とする請求項１に記 載の送液機構。 【請求項３】 前記隔壁変形手段は、直線運動しつつ前 記隔壁を押圧する又は引くプランジャーを備えることを 特徴とする請求項２に記載の送液機構。 【請求項４】 前記隔壁変形手段は、前記プランジャ (open position) ー を収納し前記プランジャーの直線運動を案内するシリン ダと、前記プランジャーを直線運動させる駆動手段と、 前記シリンダの端部に配され前記隔壁を前記液体槽の外 側から囲って密閉するカプラーと、前記カプラーに囲ま れた部分の気体の出入りを制御するバルブと、を備える ことを特徴とする請求項３に記載の送液機構。 【請求項５】 前記隔壁変形手段は、前記隔壁を押圧す るローラを備えることを特徴とする請求項２に記載の送 液機構。 【請求項６】 前記隔壁の外面に突起を設けたことを特 徴とする請求項２〜５のいずれかに記載の送液機構。 【請求項７】 前記隔壁を、気体は透過し液体は透過し ない素材で構成したことを特徴とする請求項１〜６のい ずれかに記載の送液機構。 【請求項８】 前記素材は、疎水性を有する多孔質膜で あることを特徴とする請求項７に記載の送液機構。 【請求項９】 前記多孔質膜が有機ポリマーで形成され ていることを特徴とする請求項８に記載の送液機構。 【請求項１０】 液体状の試料、又は、液体状の試料及 び液体状の試薬の混合液を流路内に流して、前記試料又 は前記混合液中の所定成分を分析する分析装置であっ て、 前記試料又は前記混合液が充填される液体槽と、前記液 体槽に連結された前記流路と、を有するチップと、 請求項１〜９のいずれかに記載の送液機構と、を備える ことを特徴とする分析装置。 【請求項１１】 前記チップは一対の平板状部材が張り 合わされて構成されており、この一対の平板状部材のう ち少なくとも一方は板面に溝を備え、前記溝を備えた板 面を内側にして張り合わせることにより前記流路が形成 されていることを特徴とする請求項１０に記載の分析装 置。 【請求項１２】 前記チップは乾燥した試薬が収納され ている液体槽を備えていて、この液体槽に溶解液を装入 して前記試薬を前記溶解液で溶解することにより、前記 液体状の試薬を前記チップ内で調製することが可能とな っていることを特徴とする請求項１０又は１１に記載の 分析装置。 【請求項１３】 複数の液体槽又は複数の流路内の液体 を液押し用液体で押し流すことにより同時に移動させる 機構を備える分析装置であって、 請求項１〜９のいずれかに記載の送液機構により送液さ れる前記液押し用液体が流れる液押し用流路を、前記複 数の液体槽又は前記複数の流路にそれぞれ連結したこと を特徴とする請求項１０〜１２のいずれかに記載の分析 装置。
US10533994B2 CLAIM 3. The system of claim 2 , wherein the pin is configured to be movable from an open position (前記プランジャ) to a closed position, wherein the pin in the closed position blocks the metering channel.	JP2003166910A CLAIM 1 【特許請求の範囲】 【請求項１】 壁体に囲まれて形成された液体槽の容積 を変化させることによって、前記液体槽に満たされた液 体を前記液体槽に連結された流路に送る、又は、前記流 路若しくは前記流路に連結された別の液体槽に収納され た液体を前記液体槽に送る送液機構であって、 前記壁体の少なくとも一部が、前記液体槽の内部又は外 部に向かって突出するように変形可能な弾性を有する隔 壁で構成されていることを特徴とする送液機構。 【請求項２】 前記隔壁を押圧して又は引いて変形させ る隔壁変形手段を備えることを特徴とする請求項１に記 載の送液機構。 【請求項３】 前記隔壁変形手段は、直線運動しつつ前 記隔壁を押圧する又は引くプランジャーを備えることを 特徴とする請求項２に記載の送液機構。 【請求項４】 前記隔壁変形手段は、前記プランジャ (open position) ー を収納し前記プランジャーの直線運動を案内するシリン ダと、前記プランジャーを直線運動させる駆動手段と、 前記シリンダの端部に配され前記隔壁を前記液体槽の外 側から囲って密閉するカプラーと、前記カプラーに囲ま れた部分の気体の出入りを制御するバルブと、を備える ことを特徴とする請求項３に記載の送液機構。 【請求項５】 前記隔壁変形手段は、前記隔壁を押圧す るローラを備えることを特徴とする請求項２に記載の送 液機構。 【請求項６】 前記隔壁の外面に突起を設けたことを特 徴とする請求項２〜５のいずれかに記載の送液機構。 【請求項７】 前記隔壁を、気体は透過し液体は透過し ない素材で構成したことを特徴とする請求項１〜６のい ずれかに記載の送液機構。 【請求項８】 前記素材は、疎水性を有する多孔質膜で あることを特徴とする請求項７に記載の送液機構。 【請求項９】 前記多孔質膜が有機ポリマーで形成され ていることを特徴とする請求項８に記載の送液機構。 【請求項１０】 液体状の試料、又は、液体状の試料及 び液体状の試薬の混合液を流路内に流して、前記試料又 は前記混合液中の所定成分を分析する分析装置であっ て、 前記試料又は前記混合液が充填される液体槽と、前記液 体槽に連結された前記流路と、を有するチップと、 請求項１〜９のいずれかに記載の送液機構と、を備える ことを特徴とする分析装置。 【請求項１１】 前記チップは一対の平板状部材が張り 合わされて構成されており、この一対の平板状部材のう ち少なくとも一方は板面に溝を備え、前記溝を備えた板 面を内側にして張り合わせることにより前記流路が形成 されていることを特徴とする請求項１０に記載の分析装 置。 【請求項１２】 前記チップは乾燥した試薬が収納され ている液体槽を備えていて、この液体槽に溶解液を装入 して前記試薬を前記溶解液で溶解することにより、前記 液体状の試薬を前記チップ内で調製することが可能とな っていることを特徴とする請求項１０又は１１に記載の 分析装置。 【請求項１３】 複数の液体槽又は複数の流路内の液体 を液押し用液体で押し流すことにより同時に移動させる 機構を備える分析装置であって、 請求項１〜９のいずれかに記載の送液機構により送液さ れる前記液押し用液体が流れる液押し用流路を、前記複 数の液体槽又は前記複数の流路にそれぞれ連結したこと を特徴とする請求項１０〜１２のいずれかに記載の分析 装置。
US10533994B2 CLAIM 10. The system of claim 1 , wherein the reaction site of the assay assembly is in fluidic communication with the sample collection unit, the reaction site containing a reactant that reacts with the analyte to yield a signal indicative of the presence of the analyte; and the assay assembly further comprises: a reagent chamber in fluidic communication with the reaction site, wherein the reagent chamber is configured to store an assay reagent; a fluidic channel connecting the reagent chamber with the reaction site; and an actuatable valve assembly configured to control the flow of reagent through the fluidic channel, wherein the valve assembly comprises a sealing element (前記隔壁, の流路) and actuator element, wherein the channel comprises first and second locations, wherein the sealing element positioned in the first location obstructs the flow of fluid through the channel and the sealing element positioned in the second location allows the flow of fluid through the channel, and wherein the actuator element is adapted to move the sealing element from the first location to the second location.	JP2003166910A CLAIM 1 【特許請求の範囲】 【請求項１】 壁体に囲まれて形成された液体槽の容積 を変化させることによって、前記液体槽に満たされた液 体を前記液体槽に連結された流路に送る、又は、前記流 路若しくは前記流路に連結された別の液体槽に収納され た液体を前記液体槽に送る送液機構であって、 前記壁体の少なくとも一部が、前記液体槽の内部又は外 部に向かって突出するように変形可能な弾性を有する隔 壁で構成されていることを特徴とする送液機構。 【請求項２】 前記隔壁 (sealing element) を押圧して又は引いて変形させ る隔壁変形手段を備えることを特徴とする請求項１に記 載の送液機構。 【請求項３】 前記隔壁変形手段は、直線運動しつつ前 記隔壁を押圧する又は引くプランジャーを備えることを 特徴とする請求項２に記載の送液機構。 【請求項４】 前記隔壁変形手段は、前記プランジャー を収納し前記プランジャーの直線運動を案内するシリン ダと、前記プランジャーを直線運動させる駆動手段と、 前記シリンダの端部に配され前記隔壁を前記液体槽の外 側から囲って密閉するカプラーと、前記カプラーに囲ま れた部分の気体の出入りを制御するバルブと、を備える ことを特徴とする請求項３に記載の送液機構。 【請求項５】 前記隔壁変形手段は、前記隔壁を押圧す るローラを備えることを特徴とする請求項２に記載の送 液機構。 【請求項６】 前記隔壁の外面に突起を設けたことを特 徴とする請求項２〜５のいずれかに記載の送液機構。 【請求項７】 前記隔壁を、気体は透過し液体は透過し ない素材で構成したことを特徴とする請求項１〜６のい ずれかに記載の送液機構。 【請求項８】 前記素材は、疎水性を有する多孔質膜で あることを特徴とする請求項７に記載の送液機構。 【請求項９】 前記多孔質膜が有機ポリマーで形成され ていることを特徴とする請求項８に記載の送液機構。 【請求項１０】 液体状の試料、又は、液体状の試料及 び液体状の試薬の混合液を流路内に流して、前記試料又 は前記混合液中の所定成分を分析する分析装置であっ て、 前記試料又は前記混合液が充填される液体槽と、前記液 体槽に連結された前記流路と、を有するチップと、 請求項１〜９のいずれかに記載の送液機構と、を備える ことを特徴とする分析装置。 【請求項１１】 前記チップは一対の平板状部材が張り 合わされて構成されており、この一対の平板状部材のう ち少なくとも一方は板面に溝を備え、前記溝を備えた板 面を内側にして張り合わせることにより前記流路が形成 されていることを特徴とする請求項１０に記載の分析装 置。 【請求項１２】 前記チップは乾燥した試薬が収納され ている液体槽を備えていて、この液体槽に溶解液を装入 して前記試薬を前記溶解液で溶解することにより、前記 液体状の試薬を前記チップ内で調製することが可能とな っていることを特徴とする請求項１０又は１１に記載の 分析装置。 【請求項１３】 複数の液体槽又は複数の流路 (sealing element) 内の液体 を液押し用液体で押し流すことにより同時に移動させる 機構を備える分析装置であって、 請求項１〜９のいずれかに記載の送液機構により送液さ れる前記液押し用液体が流れる液押し用流路を、前記複 数の液体槽又は前記複数の流路にそれぞれ連結したこと を特徴とする請求項１０〜１２のいずれかに記載の分析 装置。
US10533994B2 CLAIM 14. The system of claim 10 , wherein the actuator element comprises a sealing member such that when the actuator element moves the sealing element (前記隔壁, の流路) the sealing member forms a substantially air tight seal such that the fluid can only flow through the channel.	JP2003166910A CLAIM 1 【特許請求の範囲】 【請求項１】 壁体に囲まれて形成された液体槽の容積 を変化させることによって、前記液体槽に満たされた液 体を前記液体槽に連結された流路に送る、又は、前記流 路若しくは前記流路に連結された別の液体槽に収納され た液体を前記液体槽に送る送液機構であって、 前記壁体の少なくとも一部が、前記液体槽の内部又は外 部に向かって突出するように変形可能な弾性を有する隔 壁で構成されていることを特徴とする送液機構。 【請求項２】 前記隔壁 (sealing element) を押圧して又は引いて変形させ る隔壁変形手段を備えることを特徴とする請求項１に記 載の送液機構。 【請求項３】 前記隔壁変形手段は、直線運動しつつ前 記隔壁を押圧する又は引くプランジャーを備えることを 特徴とする請求項２に記載の送液機構。 【請求項４】 前記隔壁変形手段は、前記プランジャー を収納し前記プランジャーの直線運動を案内するシリン ダと、前記プランジャーを直線運動させる駆動手段と、 前記シリンダの端部に配され前記隔壁を前記液体槽の外 側から囲って密閉するカプラーと、前記カプラーに囲ま れた部分の気体の出入りを制御するバルブと、を備える ことを特徴とする請求項３に記載の送液機構。 【請求項５】 前記隔壁変形手段は、前記隔壁を押圧す るローラを備えることを特徴とする請求項２に記載の送 液機構。 【請求項６】 前記隔壁の外面に突起を設けたことを特 徴とする請求項２〜５のいずれかに記載の送液機構。 【請求項７】 前記隔壁を、気体は透過し液体は透過し ない素材で構成したことを特徴とする請求項１〜６のい ずれかに記載の送液機構。 【請求項８】 前記素材は、疎水性を有する多孔質膜で あることを特徴とする請求項７に記載の送液機構。 【請求項９】 前記多孔質膜が有機ポリマーで形成され ていることを特徴とする請求項８に記載の送液機構。 【請求項１０】 液体状の試料、又は、液体状の試料及 び液体状の試薬の混合液を流路内に流して、前記試料又 は前記混合液中の所定成分を分析する分析装置であっ て、 前記試料又は前記混合液が充填される液体槽と、前記液 体槽に連結された前記流路と、を有するチップと、 請求項１〜９のいずれかに記載の送液機構と、を備える ことを特徴とする分析装置。 【請求項１１】 前記チップは一対の平板状部材が張り 合わされて構成されており、この一対の平板状部材のう ち少なくとも一方は板面に溝を備え、前記溝を備えた板 面を内側にして張り合わせることにより前記流路が形成 されていることを特徴とする請求項１０に記載の分析装 置。 【請求項１２】 前記チップは乾燥した試薬が収納され ている液体槽を備えていて、この液体槽に溶解液を装入 して前記試薬を前記溶解液で溶解することにより、前記 液体状の試薬を前記チップ内で調製することが可能とな っていることを特徴とする請求項１０又は１１に記載の 分析装置。 【請求項１３】 複数の液体槽又は複数の流路 (sealing element) 内の液体 を液押し用液体で押し流すことにより同時に移動させる 機構を備える分析装置であって、 請求項１〜９のいずれかに記載の送液機構により送液さ れる前記液押し用液体が流れる液押し用流路を、前記複 数の液体槽又は前記複数の流路にそれぞれ連結したこと を特徴とする請求項１０〜１２のいずれかに記載の分析 装置。

US10533994B2 Filed: 2006-03-24     Issued: 2020-01-14 Systems and methods of sample processing and fluid control in a fluidic system (Original Assignee) Theranos IP Co LLC     (Current Assignee) Theranos IP Co LLC Elizabeth A. Holmes, Shaunak Roy, Ian Gibbons, Shize Daniel Qi, Edmond Ku, Chris Todd, Melissa Takahashi, Bruce Johnson, Jeff Fenton, Keith Moravick, Uwe Springborn, Anthony Delacruz	JP2004317498A Filed: 2004-03-18     Issued: 2004-11-11 生化学反応カートリッジ及びその使用方法 (Original Assignee) Canon Inc; キヤノン株式会社      Yasuyuki Numajiri, 泰幸 沼尻
US10533994B2 CLAIM 1. A system for detecting the presence or absence of an analyte in a bodily fluid sample (前記生) obtained from a subject, comprising: a cartridge, comprising: a sample collection unit, comprising: a sample collection well configured to receive a portion of the sample; a metering channel in fluid communication with the sample collection well and configured such that the sample flows from the sample collection well into the metering channel; and a metering element comprising a mechanically movable portion configured to be movable from an open position that permits fluid communication between the sample collection well and the metering channel to a closed position that does not provide fluid communication between the sample collection well, thereby isolating a specific volume of the sample in the metering channel; a lysing assembly configured to lyse cells present in the sample; and an assay assembly comprising a reaction site containing a reactant able to react with the analyte to yield a detectable signal indicative of the presence or absence of the analyte; and a reader assembly comprising: a detection assembly configured to detect the signal; and a communication assembly configured to receive an assay protocol in response to receiving an identity of the cartridge from an external device, the external device being separate from the reader assembly, the communication assembly further configured to transmit the signal to the external device.	JP2004317498A CLAIM 6 前記液体の移動の際に前記生 (bodily fluid sample) 化学反応カートリッジ内の空気の出口となる流路の途中に前記液体が入り込むことを防止するチャンバを設けたことを特徴とする請求項３に記載の生化学反応カートリッジの使用方法。
US10533994B2 CLAIM 4. The system of claim 2 , wherein the sample collection unit further comprises: a dilution chamber (チャンバ内) in fluidic communication with the metering channel, wherein the dilution chamber is configured to store a diluent and comprises a port engaging pressure means transferring the diluent from the dilution chamber into the metering channel.	JP2004317498A CLAIM 1 液体が蓄積された蓄積チャンバと、前記液体を移動して利用する第１、第２の機能チャンバと、前記蓄積チャンバと前記第１の機能チャンバを接続し前記液体を前記蓄積チャンバから前記第１の機能チャンバに移動する第１の流路と、前記第１の機能チャンバの底部と前記第２の機能チャンバの底部を接続し前記第１の機能チャンバ内 (dilution chamber) の液体を前記第２の機能チャンバに移動する第２の流路とを有し、前記第１の流路と前記第１の機能チャンバとを接続する第１の接続部の高さを、前記第１の機能チャンバと前記第２の流路を接続する第２の接続部の高さよりも高くしたことを特徴とする生化学反応カートリッジ。
US10533994B2 CLAIM 10. The system of claim 1 , wherein the reaction site of the assay assembly is in fluidic communication with the sample collection unit, the reaction site containing a reactant that reacts with the analyte to yield a signal indicative of the presence of the analyte; and the assay assembly further comprises: a reagent chamber in fluidic communication with the reaction site, wherein the reagent chamber is configured to store an assay reagent; a fluidic channel connecting the reagent chamber with the reaction site; and an actuatable valve assembly configured to control the flow of reagent through the fluidic channel, wherein the valve assembly comprises a sealing element (の流路) and actuator element, wherein the channel comprises first and second locations, wherein the sealing element positioned in the first location obstructs the flow of fluid through the channel and the sealing element positioned in the second location allows the flow of fluid through the channel, and wherein the actuator element is adapted to move the sealing element from the first location to the second location.	JP2004317498A CLAIM 1 液体が蓄積された蓄積チャンバと、前記液体を移動して利用する第１、第２の機能チャンバと、前記蓄積チャンバと前記第１の機能チャンバを接続し前記液体を前記蓄積チャンバから前記第１の機能チャンバに移動する第１の流路 (sealing element) と、前記第１の機能チャンバの底部と前記第２の機能チャンバの底部を接続し前記第１の機能チャンバ内の液体を前記第２の機能チャンバに移動する第２の流路とを有し、前記第１の流路と前記第１の機能チャンバとを接続する第１の接続部の高さを、前記第１の機能チャンバと前記第２の流路を接続する第２の接続部の高さよりも高くしたことを特徴とする生化学反応カートリッジ。
US10533994B2 CLAIM 14. The system of claim 10 , wherein the actuator element comprises a sealing member such that when the actuator element moves the sealing element (の流路) the sealing member forms a substantially air tight seal such that the fluid can only flow through the channel.	JP2004317498A CLAIM 1 液体が蓄積された蓄積チャンバと、前記液体を移動して利用する第１、第２の機能チャンバと、前記蓄積チャンバと前記第１の機能チャンバを接続し前記液体を前記蓄積チャンバから前記第１の機能チャンバに移動する第１の流路 (sealing element) と、前記第１の機能チャンバの底部と前記第２の機能チャンバの底部を接続し前記第１の機能チャンバ内の液体を前記第２の機能チャンバに移動する第２の流路とを有し、前記第１の流路と前記第１の機能チャンバとを接続する第１の接続部の高さを、前記第１の機能チャンバと前記第２の流路を接続する第２の接続部の高さよりも高くしたことを特徴とする生化学反応カートリッジ。

US10533994B2 Filed: 2006-03-24     Issued: 2020-01-14 Systems and methods of sample processing and fluid control in a fluidic system (Original Assignee) Theranos IP Co LLC     (Current Assignee) Theranos IP Co LLC Elizabeth A. Holmes, Shaunak Roy, Ian Gibbons, Shize Daniel Qi, Edmond Ku, Chris Todd, Melissa Takahashi, Bruce Johnson, Jeff Fenton, Keith Moravick, Uwe Springborn, Anthony Delacruz	JP2003167960A Filed: 2001-12-04     Issued: 2003-06-13 健康管理システム (Original Assignee) Hoju Planning:Kk; Ikuo Kondo; 株式会社宝樹プランニング; 近藤 郁夫      Ikuo Kondo, 藤 郁 夫 近
US10533994B2 CLAIM 1. A system for detecting the presence or absence of an analyte in a bodily fluid sample (前記生) obtained from a subject, comprising: a cartridge, comprising: a sample collection unit, comprising: a sample collection well configured to receive a portion of the sample; a metering channel in fluid communication with the sample collection well and configured such that the sample flows from the sample collection well into the metering channel; and a metering element comprising a mechanically movable portion configured to be movable from an open position (の要求) that permits fluid communication between the sample collection well and the metering channel to a closed position that does not provide fluid communication between the sample collection well, thereby isolating a specific volume of the sample in the metering channel; a lysing assembly configured to lyse cells present in the sample; and an assay assembly comprising a reaction site containing a reactant able to react with the analyte to yield a detectable signal indicative of the presence or absence of the analyte; and a reader assembly comprising: a detection assembly configured to detect the signal; and a communication assembly configured to receive an assay protocol in response to receiving an identity of the cartridge from an external device, the external device being separate from the reader assembly, the communication assembly further configured to transmit the signal to the external device.	JP2003167960A CLAIM 1 【特許請求の範囲】 【請求項１】 健康管理事業としての健康管理機関に設 置した健康管理装置から、通信ネットワークを介して、 利用者側に設置した分析・情報端末装置に情報提供する 健康管理システムに於いて、 前記分析・情報端末装置は、利用者側へ派遣された巡回 員により利用者の健康状態を直接測定する際に用いる測 定機器と接続され、測定結果に基づいた健康診断に係る 情報を利用者に提供するために、前記測定機器で測定し た生体情報をこの利用者のデータとして取り込み、その 分析結果を図表化した分析結果情報をモニタ表示するソ フトウェアを搭載しており、 前記健康管理装置は、前記生 (bodily fluid sample) 体情報と前記分析結果情報 とを取得して利用者毎に蓄積した検診履歴情報と、各利 用者の健康に関する総合アドバイス情報とを少なくとも 登録するためのデータベースを備えると共に、 前記分析結果情報に基づいた前記総合アドバイス情報を 前記分析・情報端末装置を介してその利用者に提供する アドバイス手段を備えることを特徴とする、健康管理シ ステム。 【請求項２】 前記健康管理装置は、各医療機関に設置 する医療端末装置と通信ネットワークを介してさらに接 続され、 前記データベースは、各医療機関に於ける治療方法の特 徴に関する医療機関情報をさらに備え、 前記利用者が居住する地区に所在する前記医療機関に属 する前記医療機関情報を選択し、前記分析・情報端末装 置を介してその利用者に提供する医療機関案内手段と、 前記医療機関からの要求 (open position) に応じて、前記利用者の前記検 診履歴情報を提供する検診履歴情報提供手段とをさらに 備えることを特徴とする、請求項１に記載の健康管理シ ステム。 【請求項３】 前記健康管理装置は、前記利用者が備え る利用者端末装置と通信ネットワークを介してさらに接 続され、 前記利用者が前回受診した健康診断の分析結果に基づい て、所定の期日に次回の健康診断を実施する案内情報を 前記利用者端末装置に送信する健康診断案内手段をさら に備えることを特徴とする、請求項１に記載の健康管理 システム。 【請求項４】 前記総合アドバイス情報は、身体の部位 に関する医学情報と、民間療法に関する治療情報と、食 事療法に関する食品情報と、健康増進に関する体操情報 とからなる複数の情報の内、１つ以上の情報から構成さ れることを特徴とする、請求項１に記載の健康管理シス テム。 【請求項５】 前記医療端末装置は、カード読取装置が 接続され、 前記検診履歴提供手段は、前記利用者に属する前記検診 履歴情報を提供する際に、前記カード読取装置からのカ ード媒体に記録された前記利用者に関する認証情報と前 記検診履歴情報とを照合し、照合結果が一致した場合の み、その検診履歴情報の提供を可能にする認証手段を備 えることを特徴とする、請求項１に記載の健康管理シス テム。 【請求項６】 前記測定機器は、内臓の画像を解析する 超音波診断装置と、血圧や血流を測定する装置と、経絡 臓器機能を検査する装置と、平衡障害を検査する装置 と、体脂肪を測定する装置と、骨密度を測定する装置 と、血液を検査する装置と、尿を検査する装置とからな る複数の装置の内、１つ以上の装置から構成されること を特徴とする、請求項１に記載の健康管理システム。
US10533994B2 CLAIM 3. The system of claim 2 , wherein the pin is configured to be movable from an open position (の要求) to a closed position, wherein the pin in the closed position blocks the metering channel.	JP2003167960A CLAIM 1 【特許請求の範囲】 【請求項１】 健康管理事業としての健康管理機関に設 置した健康管理装置から、通信ネットワークを介して、 利用者側に設置した分析・情報端末装置に情報提供する 健康管理システムに於いて、 前記分析・情報端末装置は、利用者側へ派遣された巡回 員により利用者の健康状態を直接測定する際に用いる測 定機器と接続され、測定結果に基づいた健康診断に係る 情報を利用者に提供するために、前記測定機器で測定し た生体情報をこの利用者のデータとして取り込み、その 分析結果を図表化した分析結果情報をモニタ表示するソ フトウェアを搭載しており、 前記健康管理装置は、前記生体情報と前記分析結果情報 とを取得して利用者毎に蓄積した検診履歴情報と、各利 用者の健康に関する総合アドバイス情報とを少なくとも 登録するためのデータベースを備えると共に、 前記分析結果情報に基づいた前記総合アドバイス情報を 前記分析・情報端末装置を介してその利用者に提供する アドバイス手段を備えることを特徴とする、健康管理シ ステム。 【請求項２】 前記健康管理装置は、各医療機関に設置 する医療端末装置と通信ネットワークを介してさらに接 続され、 前記データベースは、各医療機関に於ける治療方法の特 徴に関する医療機関情報をさらに備え、 前記利用者が居住する地区に所在する前記医療機関に属 する前記医療機関情報を選択し、前記分析・情報端末装 置を介してその利用者に提供する医療機関案内手段と、 前記医療機関からの要求 (open position) に応じて、前記利用者の前記検 診履歴情報を提供する検診履歴情報提供手段とをさらに 備えることを特徴とする、請求項１に記載の健康管理シ ステム。 【請求項３】 前記健康管理装置は、前記利用者が備え る利用者端末装置と通信ネットワークを介してさらに接 続され、 前記利用者が前回受診した健康診断の分析結果に基づい て、所定の期日に次回の健康診断を実施する案内情報を 前記利用者端末装置に送信する健康診断案内手段をさら に備えることを特徴とする、請求項１に記載の健康管理 システム。 【請求項４】 前記総合アドバイス情報は、身体の部位 に関する医学情報と、民間療法に関する治療情報と、食 事療法に関する食品情報と、健康増進に関する体操情報 とからなる複数の情報の内、１つ以上の情報から構成さ れることを特徴とする、請求項１に記載の健康管理シス テム。 【請求項５】 前記医療端末装置は、カード読取装置が 接続され、 前記検診履歴提供手段は、前記利用者に属する前記検診 履歴情報を提供する際に、前記カード読取装置からのカ ード媒体に記録された前記利用者に関する認証情報と前 記検診履歴情報とを照合し、照合結果が一致した場合の み、その検診履歴情報の提供を可能にする認証手段を備 えることを特徴とする、請求項１に記載の健康管理シス テム。 【請求項６】 前記測定機器は、内臓の画像を解析する 超音波診断装置と、血圧や血流を測定する装置と、経絡 臓器機能を検査する装置と、平衡障害を検査する装置 と、体脂肪を測定する装置と、骨密度を測定する装置 と、血液を検査する装置と、尿を検査する装置とからな る複数の装置の内、１つ以上の装置から構成されること を特徴とする、請求項１に記載の健康管理システム。

US10533994B2 Filed: 2006-03-24     Issued: 2020-01-14 Systems and methods of sample processing and fluid control in a fluidic system (Original Assignee) Theranos IP Co LLC     (Current Assignee) Theranos IP Co LLC Elizabeth A. Holmes, Shaunak Roy, Ian Gibbons, Shize Daniel Qi, Edmond Ku, Chris Todd, Melissa Takahashi, Bruce Johnson, Jeff Fenton, Keith Moravick, Uwe Springborn, Anthony Delacruz	CN2559986Y Filed: 2002-08-23     Issued: 2003-07-09 集成微流体和微阵列探针的微芯片 (Original Assignee) 上海博昇微晶科技有限公司      温龙平, 唐飞, 连崑
US10533994B2 CLAIM 1. A system for detecting the presence or absence of an analyte in a bodily fluid (微流体) sample obtained from a subject, comprising: a cartridge, comprising: a sample collection unit, comprising: a sample collection well configured to receive a portion of the sample; a metering channel in fluid communication with the sample collection well and configured such that the sample flows from the sample collection well into the metering channel; and a metering element comprising a mechanically movable portion configured to be movable from an open position that permits fluid communication between the sample collection well and the metering channel to a closed position that does not provide fluid communication between the sample collection well, thereby isolating a specific volume of the sample in the metering channel; a lysing assembly configured to lyse cells present in the sample; and an assay assembly comprising a reaction site containing a reactant able to react with the analyte to yield a detectable signal indicative of the presence or absence of the analyte; and a reader assembly comprising: a detection assembly configured to detect the signal; and a communication assembly configured to receive an assay protocol in response to receiving an identity of the cartridge from an external device, the external device being separate from the reader assembly, the communication assembly further configured to transmit the signal to the external device.	CN2559986Y CLAIM 1.一种集成微流体 (bodily fluid) 和微阵列探针的微芯片，其特征是：在所述的微芯片上具有试剂池和微流体管道，各试剂池通过各微流体管道相连；在所述各试剂池中，一个或几个试剂池的底部上具有阵列探针。
US10533994B2 CLAIM 17. The system of claim 10 , wherein the sample of bodily fluid (微流体) is less than 50 μl.	CN2559986Y CLAIM 1.一种集成微流体 (bodily fluid) 和微阵列探针的微芯片，其特征是：在所述的微芯片上具有试剂池和微流体管道，各试剂池通过各微流体管道相连；在所述各试剂池中，一个或几个试剂池的底部上具有阵列探针。

US10533994B2 Filed: 2006-03-24     Issued: 2020-01-14 Systems and methods of sample processing and fluid control in a fluidic system (Original Assignee) Theranos IP Co LLC     (Current Assignee) Theranos IP Co LLC Elizabeth A. Holmes, Shaunak Roy, Ian Gibbons, Shize Daniel Qi, Edmond Ku, Chris Todd, Melissa Takahashi, Bruce Johnson, Jeff Fenton, Keith Moravick, Uwe Springborn, Anthony Delacruz	JP2005140681A Filed: 2003-11-07     Issued: 2005-06-02 微小流路デバイスおよびその作製方法 (Original Assignee) New Industry Research Organization; 財団法人新産業創造研究機構      Hideaki Hisamoto, Shigeru Terabe, 秀明 久本, 茂 寺部
US10533994B2 CLAIM 1. A system for detecting the presence or absence of an analyte in a bodily fluid sample obtained from a subject, comprising: a cartridge, comprising: a sample collection unit, comprising: a sample collection well configured to receive a portion of the sample; a metering channel in fluid communication with the sample collection well and configured such that the sample flows from the sample collection well into the metering channel; and a metering element comprising a mechanically movable portion configured to be movable from an open position that permits fluid communication between the sample collection well and the metering channel to a closed position that does not provide fluid communication between the sample collection well, thereby isolating a specific volume of the sample in the metering channel; a lysing assembly configured to lyse cells present in the sample; and an assay assembly comprising a reaction site (操作部) containing a reactant able to react with the analyte to yield a detectable signal indicative of the presence or absence of the analyte; and a reader assembly comprising: a detection assembly configured to detect the signal; and a communication assembly configured to receive an assay protocol in response to receiving an identity of the cartridge from an external device, the external device being separate from the reader assembly, the communication assembly further configured to transmit the signal to the external device.	JP2005140681A CLAIM 2 キャピラリーは、その内部が化学修飾により化学操作部 (reaction site) にされている請求項１に記載の微小流路デバイス。
US10533994B2 CLAIM 10. The system of claim 1 , wherein the reaction site (操作部) of the assay assembly is in fluidic communication with the sample collection unit, the reaction site containing a reactant that reacts with the analyte to yield a signal indicative of the presence of the analyte; and the assay assembly further comprises: a reagent chamber in fluidic communication with the reaction site, wherein the reagent chamber is configured to store an assay reagent; a fluidic channel connecting the reagent chamber with the reaction site; and an actuatable valve assembly configured to control the flow of reagent through the fluidic channel, wherein the valve assembly comprises a sealing element (の流路) and actuator element, wherein the channel comprises first and second locations, wherein the sealing element positioned in the first location obstructs the flow of fluid through the channel and the sealing element positioned in the second location allows the flow of fluid through the channel, and wherein the actuator element is adapted to move the sealing element from the first location to the second location.	JP2005140681A CLAIM 1 内部に貫通状流路が形成され、その流路 (sealing element) の少なくとも一部にキャピラリーが埋設されてなることを特徴とする微小流路デバイス。 JP2005140681A CLAIM 2 キャピラリーは、その内部が化学修飾により化学操作部 (reaction site) にされている請求項１に記載の微小流路デバイス。
US10533994B2 CLAIM 14. The system of claim 10 , wherein the actuator element comprises a sealing member such that when the actuator element moves the sealing element (の流路) the sealing member forms a substantially air tight seal such that the fluid can only flow through the channel.	JP2005140681A CLAIM 1 内部に貫通状流路が形成され、その流路 (sealing element) の少なくとも一部にキャピラリーが埋設されてなることを特徴とする微小流路デバイス。

US10533994B2 Filed: 2006-03-24     Issued: 2020-01-14 Systems and methods of sample processing and fluid control in a fluidic system (Original Assignee) Theranos IP Co LLC     (Current Assignee) Theranos IP Co LLC Elizabeth A. Holmes, Shaunak Roy, Ian Gibbons, Shize Daniel Qi, Edmond Ku, Chris Todd, Melissa Takahashi, Bruce Johnson, Jeff Fenton, Keith Moravick, Uwe Springborn, Anthony Delacruz

EP1415788A1 Filed: 2003-10-15     Issued: 2004-05-06 Integrated microfluidic array device (Original Assignee) Agilent Technologies Inc     (Current Assignee) Agilent Technologies Inc Carol T. Schembri

US10533994B2 CLAIM 1. A system for detecting the presence or absence of an analyte in a bodily fluid sample obtained from a subject, comprising: a cartridge, comprising: a sample collection unit, comprising: a sample collection well configured to receive a portion of the sample; a metering channel in fluid communication (fluid communication) with the sample collection well and configured such that the sample flows from the sample collection well into the metering channel; and a metering element comprising a mechanically movable portion configured to be movable from an open position that permits fluid communication between the sample collection well and the metering channel to a closed position that does not provide fluid communication between the sample collection well, thereby isolating a specific volume of the sample in the metering channel; a lysing assembly configured to lyse cells present in the sample; and an assay assembly comprising a reaction site containing a reactant able to react with the analyte to yield a detectable signal indicative of the presence or absence of the analyte; and a reader assembly comprising: a detection assembly configured to detect the signal; and a communication assembly configured to receive an assay protocol in response to receiving an identity of the cartridge from an external device, the external device being separate from the reader assembly, the communication assembly further configured to transmit the signal to the external device.

EP1415788A1 CLAIM 5 A method of producing an integrated microfluidic array device comprising: a) forming a plurality of arrays by fabricating a plurality of addressable collections of probes on a flexible array substrate; b) forming a microfluidic component having a microfluidic feature; and c) placing at least one of said arrays in fluid communication (fluid communication) with said microfluidic feature of said microfluidic component.

US10533994B2 Filed: 2006-03-24     Issued: 2020-01-14 Systems and methods of sample processing and fluid control in a fluidic system (Original Assignee) Theranos IP Co LLC     (Current Assignee) Theranos IP Co LLC Elizabeth A. Holmes, Shaunak Roy, Ian Gibbons, Shize Daniel Qi, Edmond Ku, Chris Todd, Melissa Takahashi, Bruce Johnson, Jeff Fenton, Keith Moravick, Uwe Springborn, Anthony Delacruz	JP2001157855A Filed: 1999-12-03     Issued: 2001-06-12 キャピラリーゲル電気泳動用マイクロチップおよびその製造方法 (Original Assignee) Inst Of Physical & Chemical Res; 理化学研究所      Isao Endo, Teruo Fujii, Kazuo Hosokawa, Jonuku Ko, Minoru Seki, ▲じょん▼▲うく▼ 洪, 和生 細川, 輝夫 藤井, 勲 遠藤, 実 関
US10533994B2 CLAIM 1. A system for detecting the presence or absence of an analyte in a bodily fluid sample obtained from a subject, comprising: a cartridge, comprising: a sample collection unit, comprising: a sample collection well configured to receive a portion of the sample; a metering channel in fluid communication with the sample collection well and configured such that the sample flows from the sample collection well into the metering channel; and a metering element comprising a mechanically movable portion configured to be movable from an open position that permits fluid communication between the sample collection well and the metering channel to a closed position that does not provide fluid communication between the sample collection well, thereby isolating a specific volume of the sample in the metering channel; a lysing assembly configured to lyse cells present in the sample; and an assay assembly comprising a reaction site containing a reactant able to react with the analyte to yield a detectable signal indicative of the presence or absence of the analyte; and a reader assembly comprising: a detection assembly configured to detect the signal; and a communication assembly (前記基) configured to receive an assay protocol in response to receiving an identity of the cartridge from an external device, the external device being separate from the reader assembly, the communication assembly further configured to transmit the signal to the external device.	JP2001157855A CLAIM 1 【請求項１】 ポリマー材料により形成した平板状の基 板と、 前記基 (communication assembly) 板の上面に配設される平板状の表面板とを有し、 前記基板の上面に、所定の形状の流路を構成するキャピ ラリーチャネルを形成し、 前記表面板によって前記キャピラリーチャネルを封止し たものであるキャピラリーゲル電気泳動用マイクロチッ プ。
US10533994B2 CLAIM 10. The system of claim 1 , wherein the reaction site of the assay assembly is in fluidic communication with the sample collection unit, the reaction site containing a reactant that reacts with the analyte to yield a signal indicative of the presence of the analyte; and the assay assembly further comprises: a reagent chamber in fluidic communication with the reaction site, wherein the reagent chamber is configured to store an assay reagent; a fluidic channel connecting the reagent chamber with the reaction site; and an actuatable valve assembly configured to control the flow of reagent through the fluidic channel, wherein the valve assembly comprises a sealing element (の流路) and actuator element, wherein the channel comprises first and second locations, wherein the sealing element positioned in the first location obstructs the flow of fluid through the channel and the sealing element positioned in the second location allows the flow of fluid through the channel, and wherein the actuator element is adapted to move the sealing element from the first location to the second location.	JP2001157855A CLAIM 1 【請求項１】 ポリマー材料により形成した平板状の基 板と、 前記基板の上面に配設される平板状の表面板とを有し、 前記基板の上面に、所定の形状の流路 (sealing element) を構成するキャピ ラリーチャネルを形成し、 前記表面板によって前記キャピラリーチャネルを封止し たものであるキャピラリーゲル電気泳動用マイクロチッ プ。
US10533994B2 CLAIM 14. The system of claim 10 , wherein the actuator element comprises a sealing member such that when the actuator element moves the sealing element (の流路) the sealing member forms a substantially air tight seal such that the fluid can only flow through the channel.	JP2001157855A CLAIM 1 【請求項１】 ポリマー材料により形成した平板状の基 板と、 前記基板の上面に配設される平板状の表面板とを有し、 前記基板の上面に、所定の形状の流路 (sealing element) を構成するキャピ ラリーチャネルを形成し、 前記表面板によって前記キャピラリーチャネルを封止し たものであるキャピラリーゲル電気泳動用マイクロチッ プ。

US10533994B2 Filed: 2006-03-24     Issued: 2020-01-14 Systems and methods of sample processing and fluid control in a fluidic system (Original Assignee) Theranos IP Co LLC     (Current Assignee) Theranos IP Co LLC Elizabeth A. Holmes, Shaunak Roy, Ian Gibbons, Shize Daniel Qi, Edmond Ku, Chris Todd, Melissa Takahashi, Bruce Johnson, Jeff Fenton, Keith Moravick, Uwe Springborn, Anthony Delacruz	JP2005291954A Filed: 2004-03-31     Issued: 2005-10-20 使い捨て試薬パックとその試薬パックを用いる分析装置 (Original Assignee) Olympus Corp; オリンパス株式会社      Hisanobu Niimura, 寿信 新村
US10533994B2 CLAIM 1. A system for detecting the presence or absence of an analyte in a bodily fluid sample obtained from a subject, comprising: a cartridge, comprising: a sample collection unit, comprising: a sample collection well configured to receive a portion of the sample; a metering channel in fluid communication with the sample collection well and configured such that the sample flows from the sample collection well into the metering channel; and a metering element (開口部) comprising a mechanically movable portion configured to be movable from an open position that permits fluid communication between the sample collection well and the metering channel to a closed position that does not provide fluid communication between the sample collection well, thereby isolating a specific volume of the sample in the metering channel; a lysing assembly configured to lyse cells present in the sample; and an assay assembly comprising a reaction site containing a reactant able to react with the analyte to yield a detectable signal indicative of the presence or absence of the analyte; and a reader assembly comprising: a detection assembly configured to detect the signal; and a communication assembly configured to receive an assay protocol (使い捨て) in response to receiving an identity of the cartridge from an external device, the external device being separate from the reader assembly, the communication assembly further configured to transmit the signal to the external device.	JP2005291954A CLAIM 1 必要数量の使い捨て (assay protocol) チップを収容する容器と、少なくとも1つの廃液容器部と、必要種類の溶液を充填した少なくとも1つの溶液収納部とを含み、前記使い捨てチップを収容する容器と、前記廃液容器部と、前記試薬容器とが一体形成されていることを特徴とする使い捨て試薬パック。 JP2005291954A CLAIM 6 請求項１から請求項５のいずれか１項に記載の使い捨て試薬パックにおいて、溶液収納部の開口部 (metering element) に蓋フィルムが設けられていることを特徴とする試薬パック。
US10533994B2 CLAIM 2. The system of claim 1 , wherein the metering element (開口部) comprises a pin.	JP2005291954A CLAIM 6 請求項１から請求項５のいずれか１項に記載の使い捨て試薬パックにおいて、溶液収納部の開口部 (metering element) に蓋フィルムが設けられていることを特徴とする試薬パック。
US10533994B2 CLAIM 18. The system of claim 1 , wherein the assay protocol (使い捨て) is transmitted wirelessly from the external device.	JP2005291954A CLAIM 1 必要数量の使い捨て (assay protocol) チップを収容する容器と、少なくとも1つの廃液容器部と、必要種類の溶液を充填した少なくとも1つの溶液収納部とを含み、前記使い捨てチップを収容する容器と、前記廃液容器部と、前記試薬容器とが一体形成されていることを特徴とする使い捨て試薬パック。

US10533994B2 Filed: 2006-03-24     Issued: 2020-01-14 Systems and methods of sample processing and fluid control in a fluidic system (Original Assignee) Theranos IP Co LLC     (Current Assignee) Theranos IP Co LLC Elizabeth A. Holmes, Shaunak Roy, Ian Gibbons, Shize Daniel Qi, Edmond Ku, Chris Todd, Melissa Takahashi, Bruce Johnson, Jeff Fenton, Keith Moravick, Uwe Springborn, Anthony Delacruz	JP2005010179A Filed: 2004-09-27     Issued: 2005-01-13 容器 (Original Assignee) Precision System Science Co Ltd; プレシジョン・システム・サイエンス株式会社      Hideji Tajima, 秀二 田島
US10533994B2 CLAIM 1. A system for detecting the presence or absence of an analyte in a bodily fluid sample (該液体) obtained from a subject, comprising: a cartridge, comprising: a sample collection unit, comprising: a sample collection well configured to receive a portion of the sample; a metering channel in fluid communication with the sample collection well and configured such that the sample flows from the sample collection well into the metering channel; and a metering element comprising a mechanically movable portion configured to be movable from an open position that permits fluid communication between the sample collection well and the metering channel to a closed position that does not provide fluid communication between the sample collection well, thereby isolating a specific volume of the sample in the metering channel; a lysing assembly configured to lyse cells present in the sample; and an assay assembly comprising a reaction site containing a reactant able to react with the analyte to yield a detectable signal indicative of the presence or absence of the analyte; and a reader assembly comprising: a detection assembly (受光部) configured to detect the signal; and a communication assembly (少なくとも１) configured to receive an assay protocol in response to receiving an identity of the cartridge from an external device, the external device being separate from the reader assembly, the communication assembly further configured to transmit the signal to the external device.	JP2005010179A CLAIM 1 容器本体の内底部は、その中央近傍に該容器内に挿脱される液体吸排ラインの先端部の口径よりも幅狭の空隙部を形成するとともに、容器壁から該空隙部の縁に至る一様な下がり勾配の傾斜面を形成し、該空隙部は、上記液体吸排ラインの先端部が上記内底部に当接しても、該液体 (bodily fluid sample) 吸排ラインの先端部から液体を全量吸引し吐出できる形状に形成されていることを特徴とする容器。 JP2005010179A CLAIM 11 前記カートリッジ容器は、基部と、当該基部に列状に設けられた複数個の収容部とを有し、当該複数個の収容部には、処理用の収容部、光学測定用の測定器若しくは受光部 (detection assembly) と遮光状態で連結可能な測定用収容部若しくはその保持用穴部、ピペットチップの収容部若しくはその保持用穴部、ＰＣＲ用チューブ若しくはその保持用穴部、又は固相された収容部若しくはその保持用穴部の全部若しくはいずれかが処理に応じた必要数含まれていることを特徴とする請求項６乃至請求項１０のいずれかに記載された容器。 JP2005010179A CLAIM 18 前記収容部の少なくとも１ (communication assembly) つは、恒温手段に対応する構造に形成されたことを特徴とする請求項６乃至請求項１７のいずれかに記載された容器。
US10533994B2 CLAIM 14. The system of claim 10 , wherein the actuator element comprises a sealing member such that when the actuator element moves the sealing element the sealing member forms a substantially air tight seal (用穴部) such that the fluid can only flow through the channel.	JP2005010179A CLAIM 11 前記カートリッジ容器は、基部と、当該基部に列状に設けられた複数個の収容部とを有し、当該複数個の収容部には、処理用の収容部、光学測定用の測定器若しくは受光部と遮光状態で連結可能な測定用収容部若しくはその保持用穴部 (tight seal) 、ピペットチップの収容部若しくはその保持用穴部、ＰＣＲ用チューブ若しくはその保持用穴部、又は固相された収容部若しくはその保持用穴部の全部若しくはいずれかが処理に応じた必要数含まれていることを特徴とする請求項６乃至請求項１０のいずれかに記載された容器。

US10533994B2 Filed: 2006-03-24     Issued: 2020-01-14 Systems and methods of sample processing and fluid control in a fluidic system (Original Assignee) Theranos IP Co LLC     (Current Assignee) Theranos IP Co LLC Elizabeth A. Holmes, Shaunak Roy, Ian Gibbons, Shize Daniel Qi, Edmond Ku, Chris Todd, Melissa Takahashi, Bruce Johnson, Jeff Fenton, Keith Moravick, Uwe Springborn, Anthony Delacruz	JP2004101381A Filed: 2002-09-10     Issued: 2004-04-02 自動分析装置用の複光路セル及びこの複光路セルを用いた分析方法 (Original Assignee) Nittec Co Ltd; 株式会社ニッテク      Koichi Wakatake, 若竹　孝一
US10533994B2 CLAIM 1. A system for detecting the presence or absence of an analyte in a bodily fluid sample obtained from a subject, comprising: a cartridge, comprising: a sample collection unit, comprising: a sample collection well configured to receive a portion of the sample; a metering channel in fluid communication with the sample collection well and configured such that the sample flows from the sample collection well into the metering channel; and a metering element comprising a mechanically movable portion configured to be movable from an open position that permits fluid communication between the sample collection well and the metering channel to a closed position that does not provide fluid communication between the sample collection well, thereby isolating a specific volume of the sample in the metering channel; a lysing assembly configured to lyse cells present in the sample; and an assay assembly comprising a reaction site (該反応) containing a reactant able to react with the analyte to yield a detectable signal indicative of the presence or absence of the analyte; and a reader assembly comprising: a detection assembly configured to detect the signal; and a communication assembly configured to receive an assay protocol in response to receiving an identity of the cartridge from an external device, the external device being separate from the reader assembly, the communication assembly further configured to transmit the signal to the external device.	JP2004101381A CLAIM 1 被測定液が収容された透光性材質で形成されてなる反応／測定セルを、該反応 (reaction site) ／測定セルの移送路を横断するように配設された光測定路を通過させることで、上記被測定液の吸光度を測定するために用いられる自動分析装置用の反応／測定セルにおいて、該反応／測定セルには、光路長が異なる複数の段部を形成し、上記測定光を、当該反応／測定セルの各段部を透過させることで、複数の異なる吸光度を得ることができるように構成したことを特徴とする自動分析装置用の複光路セル。
US10533994B2 CLAIM 10. The system of claim 1 , wherein the reaction site (該反応) of the assay assembly is in fluidic communication with the sample collection unit, the reaction site containing a reactant that reacts with the analyte to yield a signal indicative of the presence of the analyte; and the assay assembly further comprises: a reagent chamber in fluidic communication with the reaction site, wherein the reagent chamber is configured to store an assay reagent; a fluidic channel connecting the reagent chamber with the reaction site; and an actuatable valve assembly configured to control the flow of reagent through the fluidic channel, wherein the valve assembly comprises a sealing element and actuator element, wherein the channel comprises first and second locations, wherein the sealing element positioned in the first location obstructs the flow of fluid through the channel and the sealing element positioned in the second location allows the flow of fluid through the channel, and wherein the actuator element is adapted to move the sealing element from the first location to the second location.	JP2004101381A CLAIM 1 被測定液が収容された透光性材質で形成されてなる反応／測定セルを、該反応 (reaction site) ／測定セルの移送路を横断するように配設された光測定路を通過させることで、上記被測定液の吸光度を測定するために用いられる自動分析装置用の反応／測定セルにおいて、該反応／測定セルには、光路長が異なる複数の段部を形成し、上記測定光を、当該反応／測定セルの各段部を透過させることで、複数の異なる吸光度を得ることができるように構成したことを特徴とする自動分析装置用の複光路セル。

US10533994B2 Filed: 2006-03-24     Issued: 2020-01-14 Systems and methods of sample processing and fluid control in a fluidic system (Original Assignee) Theranos IP Co LLC     (Current Assignee) Theranos IP Co LLC Elizabeth A. Holmes, Shaunak Roy, Ian Gibbons, Shize Daniel Qi, Edmond Ku, Chris Todd, Melissa Takahashi, Bruce Johnson, Jeff Fenton, Keith Moravick, Uwe Springborn, Anthony Delacruz	JPH08211071A Filed: 1995-10-27     Issued: 1996-08-20 自動分析装置及びその方法 (Original Assignee) Precision Syst Sci Kk; プレシジョン・システム・サイエンス株式会社      Hideji Tajima, 秀二 田島
US10533994B2 CLAIM 10. The system of claim 1 , wherein the reaction site of the assay assembly is in fluidic communication with the sample collection unit, the reaction site containing a reactant that reacts with the analyte to yield a signal indicative of the presence of the analyte; and the assay assembly further comprises: a reagent chamber in fluidic communication with the reaction site, wherein the reagent chamber is configured to store an assay reagent; a fluidic channel connecting the reagent chamber with the reaction site; and an actuatable valve assembly configured to control the flow of reagent through the fluidic channel, wherein the valve assembly comprises a sealing element and actuator element, wherein the channel comprises first and second locations, wherein the sealing element positioned in the first location obstructs the flow of fluid through the channel and the sealing element positioned in the second location (分注位置) allows the flow of fluid through the channel, and wherein the actuator element is adapted to move the sealing element from the first location to the second location.	JPH08211071A CLAIM 1 【請求項１】 指令によって分注位置 (second location) で分注作業を行う ピペット装置と、指令によって装填されたカートリッジ 容器を所定位置まで移送するカートリッジ容器移送手段 と、指令によってカートリッジ容器内の試料に対して測 定を行う測定手段と、カートリッジ容器を分注位置及び 測定位置へと移送させて分注及び測定を指令する制御装 置と、を有して構成されてなる自動分析装置。
US10533994B2 CLAIM 13. The system of claim 10 , wherein the second location (分注位置) has a larger cross section than the first location.	JPH08211071A CLAIM 1 【請求項１】 指令によって分注位置 (second location) で分注作業を行う ピペット装置と、指令によって装填されたカートリッジ 容器を所定位置まで移送するカートリッジ容器移送手段 と、指令によってカートリッジ容器内の試料に対して測 定を行う測定手段と、カートリッジ容器を分注位置及び 測定位置へと移送させて分注及び測定を指令する制御装 置と、を有して構成されてなる自動分析装置。

US10533994B2 Filed: 2006-03-24     Issued: 2020-01-14 Systems and methods of sample processing and fluid control in a fluidic system (Original Assignee) Theranos IP Co LLC     (Current Assignee) Theranos IP Co LLC Elizabeth A. Holmes, Shaunak Roy, Ian Gibbons, Shize Daniel Qi, Edmond Ku, Chris Todd, Melissa Takahashi, Bruce Johnson, Jeff Fenton, Keith Moravick, Uwe Springborn, Anthony Delacruz	EP0637998A1 Filed: 1993-04-29     Issued: 1995-02-15 Fluid handling in microfabricated analytical devices. (Original Assignee) University of Pennsylvania     (Current Assignee) University of Pennsylvania Peter Wilding, Larry J Kricka, Jay N Zemel
US10533994B2 CLAIM 1. A system for detecting the presence or absence of an analyte in a bodily fluid sample obtained from a subject, comprising: a cartridge, comprising: a sample collection unit, comprising: a sample collection well configured to receive a portion of the sample; a metering channel in fluid communication (fluid communication) with the sample collection well and configured such that the sample flows from the sample collection well into the metering channel; and a metering element (said flow passage) comprising a mechanically movable portion configured to be movable from an open position that permits fluid communication between the sample collection well and the metering channel to a closed position that does not provide fluid communication between the sample collection well, thereby isolating a specific volume of the sample in the metering channel; a lysing assembly configured to lyse cells present in the sample; and an assay assembly comprising a reaction site containing a reactant able to react with the analyte to yield a detectable signal indicative of the presence or absence of the analyte; and a reader assembly comprising: a detection assembly configured to detect the signal; and a communication assembly configured to receive an assay protocol in response to receiving an identity of the cartridge from an external device, the external device being separate from the reader assembly, the communication assembly further configured to transmit the signal to the external device.	EP0637998A1 CLAIM 1. A device for analyzing a fluid, cell- containing sample, the device comprising a solid substrate microfabricated to define: a sample inlet port; and a mesoscale flow system comprising: a sample flow channel extending from said inlet port; and a cell handling region for treating cells disposed in fluid communication (fluid communication) with said flow channel. EP0637998A1 CLAIM 26. A method of separating a target subpopulation of cells in a cell-containing liquid sample comprising the steps of: (A) providing a mesoscale sample flow passage comprising a solid wall having immobilized thereon a binding protein specific for a cell membrane-bound protein characteristic of said target population; (B) passing a cell-containing liquid sample through said passage under conditions to permit capture of members of the cell target subpopulation by reversible cell surface protein-immobilized protein binding, while permitting other cells to pass therethrough; and (C) changing the conditions in said flow passage (metering element) to release said target subpopulation of cells.
US10533994B2 CLAIM 2. The system of claim 1 , wherein the metering element (said flow passage) comprises a pin.	EP0637998A1 CLAIM 26. A method of separating a target subpopulation of cells in a cell-containing liquid sample comprising the steps of: (A) providing a mesoscale sample flow passage comprising a solid wall having immobilized thereon a binding protein specific for a cell membrane-bound protein characteristic of said target population; (B) passing a cell-containing liquid sample through said passage under conditions to permit capture of members of the cell target subpopulation by reversible cell surface protein-immobilized protein binding, while permitting other cells to pass therethrough; and (C) changing the conditions in said flow passage (metering element) to release said target subpopulation of cells.
US10533994B2 CLAIM 10. The system of claim 1 , wherein the reaction site of the assay assembly is in fluidic communication with the sample collection unit, the reaction site containing a reactant that reacts with the analyte to yield a signal indicative of the presence of the analyte; and the assay assembly further comprises: a reagent chamber in fluidic communication with the reaction site, wherein the reagent chamber is configured to store an assay reagent; a fluidic channel connecting the reagent chamber with the reaction site; and an actuatable valve assembly configured to control the flow of reagent through the fluidic channel, wherein the valve assembly comprises a sealing element (system further comprises means) and actuator element, wherein the channel comprises first and second locations, wherein the sealing element positioned in the first location obstructs the flow of fluid through the channel and the sealing element positioned in the second location allows the flow of fluid through the channel, and wherein the actuator element is adapted to move the sealing element from the first location to the second location.	EP0637998A1 CLAIM 12. The device of claim 11 wherein said flow system further comprises means (sealing element) downstream of said cell capture region for determining the presence of an extracellular component of said sample.
US10533994B2 CLAIM 14. The system of claim 10 , wherein the actuator element comprises a sealing member (said holding means) such that when the actuator element moves the sealing element (system further comprises means) the sealing member forms a substantially air tight seal such that the fluid can only flow through the channel.	EP0637998A1 CLAIM 12. The device of claim 11 wherein said flow system further comprises means (sealing element) downstream of said cell capture region for determining the presence of an extracellular component of said sample. EP0637998A1 CLAIM 17. The device of claim 2 further comprising an appliance for use in combination with said substrate, said appliance comprising: means for holding said substrate; and fluid input means interfitting with an inlet port on said substrate; and wherein said means for inducing flow comprises pump means, disposed in said appliance, for passing fluid through the flow system of said substrate when it is held in said holding means (sealing member) . ^
US10533994B2 CLAIM 15. The system of claim 14 wherein the actuator element is substantially pin shaped and the sealing member (said holding means) is an O-ring adapted to be placed around the actuator element.	EP0637998A1 CLAIM 17. The device of claim 2 further comprising an appliance for use in combination with said substrate, said appliance comprising: means for holding said substrate; and fluid input means interfitting with an inlet port on said substrate; and wherein said means for inducing flow comprises pump means, disposed in said appliance, for passing fluid through the flow system of said substrate when it is held in said holding means (sealing member) . ^

US10533994B2 Filed: 2006-03-24     Issued: 2020-01-14 Systems and methods of sample processing and fluid control in a fluidic system (Original Assignee) Theranos IP Co LLC     (Current Assignee) Theranos IP Co LLC Elizabeth A. Holmes, Shaunak Roy, Ian Gibbons, Shize Daniel Qi, Edmond Ku, Chris Todd, Melissa Takahashi, Bruce Johnson, Jeff Fenton, Keith Moravick, Uwe Springborn, Anthony Delacruz	JP2003329696A Filed: 2002-05-15     Issued: 2003-11-19 化学発光酵素免疫測定装置 (Original Assignee) Horiba Ltd; Precision System Science Co Ltd; プレシジョン・システム・サイエンス株式会社; 株式会社堀場製作所      Takeshi Kono, Yasumi Nakajima, Hideji Tajima, 保泉 中島, 猛 河野, 秀二 田島
US10533994B2 CLAIM 1. A system for detecting the presence or absence of an analyte in a bodily fluid sample obtained from a subject, comprising: a cartridge, comprising: a sample collection unit, comprising: a sample collection well configured to receive a portion of the sample; a metering channel in fluid communication with the sample collection well and configured such that the sample flows from the sample collection well into the metering channel; and a metering element comprising a mechanically movable portion configured to be movable from an open position that permits fluid communication between the sample collection well and the metering channel to a closed position that does not provide fluid communication between the sample collection well, thereby isolating a specific volume of the sample in the metering channel; a lysing assembly configured to lyse cells present in the sample; and an assay assembly (移動自在) comprising a reaction site (免疫反応) containing a reactant able to react with the analyte to yield a detectable signal indicative of the presence or absence of the analyte; and a reader assembly (移動自在) comprising: a detection assembly configured to detect the signal; and a communication assembly configured to receive an assay protocol in response to receiving an identity of the cartridge from an external device, the external device being separate from the reader assembly, the communication assembly further configured to transmit the signal to the external device.	JP2003329696A CLAIM 1 【特許請求の範囲】 【請求項１】 表面に抗原や抗体を固相した磁性微粒子 を用いた化学発光酵素免疫測定装置において、平面視円 形のターンテーブルの上面にインキュベート機能を有す る複数のステージを形成し、各ステージは、検体、磁性 微粒子、免疫反応 (reaction site) に必要な試薬および洗浄液等の液体を 収容するとともに所定の免疫反応を行わせるための複数 のウェルが形成された複数のカートリッジを着脱自在 に、かつ各カートリッジの外側の端面が前記ターンテー ブルの外周の曲率半径と等しい曲率半径を有する円弧上 に並ぶようにして位置させる一方、一つのステージにセ ットされた複数のカートリッジに対してそれぞれ対応す るように設けられ、磁性微粒子吸着保持機能を有するデ ィスペンサを複数備えたディスペンサユニットを、前記 ターンテーブルの回転中心側から装置前面側との間を直 線的に移動自在 (assay assembly, reader assembly, valve assembly) に設け、さらに、前記複数のディスペン サを、前記ターンテーブルの外周の曲率半径と等しい曲 率半径を有する円弧上に並ぶように配列したことを特徴 とする化学発光酵素免疫測定装置。 【請求項２】 カートリッジは、その複数のウェルの底 部が尖っているとともに、液を収容したときの液面の高 さがどのウェルにおいても等しくなるようにそれらの形 状および大きさが設定されている請求項１に記載の化学 発光酵素免疫測定装置。 【請求項３】 ターンテーブルの周辺に設けられカート リッジの測定ウェルに収容された免疫反応後の液体に発 光基質を注入する発光基質注入部と、前記測定ウェルに おいて生ずる化学発光を測定する化学発光測定部と、装 置各部を制御するとともに前記化学発光測定部からの信 号を処理する演算制御部とを備えている請求項１または ２に記載の化学発光酵素免疫測定装置。
US10533994B2 CLAIM 8. The system of claim 1 , wherein the assay assembly (移動自在) is adapted to run an immunoassay.	JP2003329696A CLAIM 1 【特許請求の範囲】 【請求項１】 表面に抗原や抗体を固相した磁性微粒子 を用いた化学発光酵素免疫測定装置において、平面視円 形のターンテーブルの上面にインキュベート機能を有す る複数のステージを形成し、各ステージは、検体、磁性 微粒子、免疫反応に必要な試薬および洗浄液等の液体を 収容するとともに所定の免疫反応を行わせるための複数 のウェルが形成された複数のカートリッジを着脱自在 に、かつ各カートリッジの外側の端面が前記ターンテー ブルの外周の曲率半径と等しい曲率半径を有する円弧上 に並ぶようにして位置させる一方、一つのステージにセ ットされた複数のカートリッジに対してそれぞれ対応す るように設けられ、磁性微粒子吸着保持機能を有するデ ィスペンサを複数備えたディスペンサユニットを、前記 ターンテーブルの回転中心側から装置前面側との間を直 線的に移動自在 (assay assembly, reader assembly, valve assembly) に設け、さらに、前記複数のディスペン サを、前記ターンテーブルの外周の曲率半径と等しい曲 率半径を有する円弧上に並ぶように配列したことを特徴 とする化学発光酵素免疫測定装置。 【請求項２】 カートリッジは、その複数のウェルの底 部が尖っているとともに、液を収容したときの液面の高 さがどのウェルにおいても等しくなるようにそれらの形 状および大きさが設定されている請求項１に記載の化学 発光酵素免疫測定装置。 【請求項３】 ターンテーブルの周辺に設けられカート リッジの測定ウェルに収容された免疫反応後の液体に発 光基質を注入する発光基質注入部と、前記測定ウェルに おいて生ずる化学発光を測定する化学発光測定部と、装 置各部を制御するとともに前記化学発光測定部からの信 号を処理する演算制御部とを備えている請求項１または ２に記載の化学発光酵素免疫測定装置。
US10533994B2 CLAIM 9. The system of claim 8 , wherein the assay assembly (移動自在) comprises a reagent chamber in fluidic communication with the reaction site, wherein the reagent chamber is configured to store an assay reagent.	JP2003329696A CLAIM 1 【特許請求の範囲】 【請求項１】 表面に抗原や抗体を固相した磁性微粒子 を用いた化学発光酵素免疫測定装置において、平面視円 形のターンテーブルの上面にインキュベート機能を有す る複数のステージを形成し、各ステージは、検体、磁性 微粒子、免疫反応に必要な試薬および洗浄液等の液体を 収容するとともに所定の免疫反応を行わせるための複数 のウェルが形成された複数のカートリッジを着脱自在 に、かつ各カートリッジの外側の端面が前記ターンテー ブルの外周の曲率半径と等しい曲率半径を有する円弧上 に並ぶようにして位置させる一方、一つのステージにセ ットされた複数のカートリッジに対してそれぞれ対応す るように設けられ、磁性微粒子吸着保持機能を有するデ ィスペンサを複数備えたディスペンサユニットを、前記 ターンテーブルの回転中心側から装置前面側との間を直 線的に移動自在 (assay assembly, reader assembly, valve assembly) に設け、さらに、前記複数のディスペン サを、前記ターンテーブルの外周の曲率半径と等しい曲 率半径を有する円弧上に並ぶように配列したことを特徴 とする化学発光酵素免疫測定装置。 【請求項２】 カートリッジは、その複数のウェルの底 部が尖っているとともに、液を収容したときの液面の高 さがどのウェルにおいても等しくなるようにそれらの形 状および大きさが設定されている請求項１に記載の化学 発光酵素免疫測定装置。 【請求項３】 ターンテーブルの周辺に設けられカート リッジの測定ウェルに収容された免疫反応後の液体に発 光基質を注入する発光基質注入部と、前記測定ウェルに おいて生ずる化学発光を測定する化学発光測定部と、装 置各部を制御するとともに前記化学発光測定部からの信 号を処理する演算制御部とを備えている請求項１または ２に記載の化学発光酵素免疫測定装置。
US10533994B2 CLAIM 10. The system of claim 1 , wherein the reaction site (免疫反応) of the assay assembly (移動自在) is in fluidic communication with the sample collection unit, the reaction site containing a reactant that reacts with the analyte to yield a signal indicative of the presence of the analyte; and the assay assembly further comprises: a reagent chamber in fluidic communication with the reaction site, wherein the reagent chamber is configured to store an assay reagent; a fluidic channel connecting the reagent chamber with the reaction site; and an actuatable valve assembly (移動自在) configured to control the flow of reagent through the fluidic channel, wherein the valve assembly comprises a sealing element and actuator element, wherein the channel comprises first and second locations, wherein the sealing element positioned in the first location obstructs the flow of fluid through the channel and the sealing element positioned in the second location allows the flow of fluid through the channel, and wherein the actuator element is adapted to move the sealing element from the first location to the second location.	JP2003329696A CLAIM 1 【特許請求の範囲】 【請求項１】 表面に抗原や抗体を固相した磁性微粒子 を用いた化学発光酵素免疫測定装置において、平面視円 形のターンテーブルの上面にインキュベート機能を有す る複数のステージを形成し、各ステージは、検体、磁性 微粒子、免疫反応 (reaction site) に必要な試薬および洗浄液等の液体を 収容するとともに所定の免疫反応を行わせるための複数 のウェルが形成された複数のカートリッジを着脱自在 に、かつ各カートリッジの外側の端面が前記ターンテー ブルの外周の曲率半径と等しい曲率半径を有する円弧上 に並ぶようにして位置させる一方、一つのステージにセ ットされた複数のカートリッジに対してそれぞれ対応す るように設けられ、磁性微粒子吸着保持機能を有するデ ィスペンサを複数備えたディスペンサユニットを、前記 ターンテーブルの回転中心側から装置前面側との間を直 線的に移動自在 (assay assembly, reader assembly, valve assembly) に設け、さらに、前記複数のディスペン サを、前記ターンテーブルの外周の曲率半径と等しい曲 率半径を有する円弧上に並ぶように配列したことを特徴 とする化学発光酵素免疫測定装置。 【請求項２】 カートリッジは、その複数のウェルの底 部が尖っているとともに、液を収容したときの液面の高 さがどのウェルにおいても等しくなるようにそれらの形 状および大きさが設定されている請求項１に記載の化学 発光酵素免疫測定装置。 【請求項３】 ターンテーブルの周辺に設けられカート リッジの測定ウェルに収容された免疫反応後の液体に発 光基質を注入する発光基質注入部と、前記測定ウェルに おいて生ずる化学発光を測定する化学発光測定部と、装 置各部を制御するとともに前記化学発光測定部からの信 号を処理する演算制御部とを備えている請求項１または ２に記載の化学発光酵素免疫測定装置。
US10533994B2 CLAIM 16. The fluidic device of claim 10 , wherein the assay assembly (移動自在) is adapted to run an immunoassay.	JP2003329696A CLAIM 1 【特許請求の範囲】 【請求項１】 表面に抗原や抗体を固相した磁性微粒子 を用いた化学発光酵素免疫測定装置において、平面視円 形のターンテーブルの上面にインキュベート機能を有す る複数のステージを形成し、各ステージは、検体、磁性 微粒子、免疫反応に必要な試薬および洗浄液等の液体を 収容するとともに所定の免疫反応を行わせるための複数 のウェルが形成された複数のカートリッジを着脱自在 に、かつ各カートリッジの外側の端面が前記ターンテー ブルの外周の曲率半径と等しい曲率半径を有する円弧上 に並ぶようにして位置させる一方、一つのステージにセ ットされた複数のカートリッジに対してそれぞれ対応す るように設けられ、磁性微粒子吸着保持機能を有するデ ィスペンサを複数備えたディスペンサユニットを、前記 ターンテーブルの回転中心側から装置前面側との間を直 線的に移動自在 (assay assembly, reader assembly, valve assembly) に設け、さらに、前記複数のディスペン サを、前記ターンテーブルの外周の曲率半径と等しい曲 率半径を有する円弧上に並ぶように配列したことを特徴 とする化学発光酵素免疫測定装置。 【請求項２】 カートリッジは、その複数のウェルの底 部が尖っているとともに、液を収容したときの液面の高 さがどのウェルにおいても等しくなるようにそれらの形 状および大きさが設定されている請求項１に記載の化学 発光酵素免疫測定装置。 【請求項３】 ターンテーブルの周辺に設けられカート リッジの測定ウェルに収容された免疫反応後の液体に発 光基質を注入する発光基質注入部と、前記測定ウェルに おいて生ずる化学発光を測定する化学発光測定部と、装 置各部を制御するとともに前記化学発光測定部からの信 号を処理する演算制御部とを備えている請求項１または ２に記載の化学発光酵素免疫測定装置。

US10533994B2 Filed: 2006-03-24     Issued: 2020-01-14 Systems and methods of sample processing and fluid control in a fluidic system (Original Assignee) Theranos IP Co LLC     (Current Assignee) Theranos IP Co LLC Elizabeth A. Holmes, Shaunak Roy, Ian Gibbons, Shize Daniel Qi, Edmond Ku, Chris Todd, Melissa Takahashi, Bruce Johnson, Jeff Fenton, Keith Moravick, Uwe Springborn, Anthony Delacruz	JPH1157560A Filed: 1997-08-27     Issued: 1999-03-02 液体散布車 (Original Assignee) Shin Meiwa Ind Co Ltd; 新明和工業株式会社      Masaru Nitta, Yasushi Okamoto, 靖 岡本, 優 新田
US10533994B2 CLAIM 1. A system for detecting the presence or absence of an analyte in a bodily fluid sample obtained from a subject, comprising: a cartridge, comprising: a sample collection unit, comprising: a sample collection well configured to receive a portion of the sample; a metering channel in fluid communication with the sample collection well and configured such that the sample flows from the sample collection well into the metering channel; and a metering element comprising a mechanically movable portion configured to be movable from an open position that permits fluid communication between the sample collection well and the metering channel to a closed position that does not provide fluid communication between the sample collection well, thereby isolating a specific volume of the sample in the metering channel; a lysing assembly configured to lyse cells present in the sample; and an assay assembly comprising a reaction site containing a reactant able to react with the analyte to yield a detectable signal indicative of the presence or absence of the analyte; and a reader assembly comprising: a detection assembly (検出信号) configured to detect the signal; and a communication assembly configured to receive an assay protocol in response to receiving an identity of the cartridge from an external device, the external device being separate from the reader assembly, the communication assembly further configured to transmit the signal to the external device.	JPH1157560A CLAIM 1 【請求項１】 車体上に液体貯留タンクが載置され、液 体貯留タンクに連通された散布ノズルが車体の適所に配 置された液体散布車において、 前記散布ノズルは、適宜なアクチュエータにより少なく とも車輌の幅方向に水平面上を揺動自在に設けられ、車 輌の走行状況を検出する検出装置からの検出信号 (detection assembly) に基づ いて散布ノズルの揺動動作が制御されるように構成され たことを特徴とする液体散布車。
US10533994B2 CLAIM 4. The system of claim 2 , wherein the sample collection unit further comprises: a dilution chamber (水平面) in fluidic communication with the metering channel, wherein the dilution chamber is configured to store a diluent and comprises a port engaging pressure means transferring the diluent from the dilution chamber into the metering channel.	JPH1157560A CLAIM 1 【請求項１】 車体上に液体貯留タンクが載置され、液 体貯留タンクに連通された散布ノズルが車体の適所に配 置された液体散布車において、 前記散布ノズルは、適宜なアクチュエータにより少なく とも車輌の幅方向に水平面 (dilution chamber) 上を揺動自在に設けられ、車 輌の走行状況を検出する検出装置からの検出信号に基づ いて散布ノズルの揺動動作が制御されるように構成され たことを特徴とする液体散布車。

US10533994B2 Filed: 2006-03-24     Issued: 2020-01-14 Systems and methods of sample processing and fluid control in a fluidic system (Original Assignee) Theranos IP Co LLC     (Current Assignee) Theranos IP Co LLC Elizabeth A. Holmes, Shaunak Roy, Ian Gibbons, Shize Daniel Qi, Edmond Ku, Chris Todd, Melissa Takahashi, Bruce Johnson, Jeff Fenton, Keith Moravick, Uwe Springborn, Anthony Delacruz	CN1173776A Filed: 1997-01-27     Issued: 1998-02-18 使用运动和空间相关的隔行向顺序转换装置和方法 (Original Assignee) 三星电子株式会社      金永泽
US10533994B2 CLAIM 1. A system for detecting the presence or absence of an analyte in a bodily fluid sample obtained from a subject, comprising: a cartridge, comprising: a sample collection unit, comprising: a sample collection well configured to receive a portion of the sample; a metering channel in fluid communication with the sample collection well and configured such that the sample flows from the sample collection well into the metering channel; and a metering element comprising a mechanically movable portion configured to be movable from an open position that permits fluid communication between the sample collection well and the metering channel to a closed position that does not provide fluid communication between the sample collection well, thereby isolating a specific volume of the sample in the metering channel; a lysing assembly configured to lyse cells present in the sample; and an assay assembly comprising a reaction site containing a reactant able to react with the analyte to yield a detectable signal indicative of the presence or absence of the analyte; and a reader assembly comprising: a detection assembly (用于检测第一) configured to detect the signal; and a communication assembly configured to receive an assay protocol in response to receiving an identity of the cartridge from an external device, the external device being separate from the reader assembly, the communication assembly further configured to transmit the signal to the external device.	CN1173776A CLAIM 2.根据权利要求1所述的隔行向顺序转换装置，其中所述运动空间相关装置包括：第一检测装置，用于检测第一 (detection assembly) 取样组和第二取样组之间的运动相关，该第一取样组在包括与当前内插取样相同的位置上的第一取样、第一取样之前的取样和第一取样之后的取样及在前一行和后一行中与第一取样在相同水平位置上的取样的前一场中，该第二取样组在包括与当前内插取样相同的位置上的第二取样、第二取样之前的取样和第二取样之后的取样及在前一行和后一行中与第二取样在相同水平位置上的取样的下一场中；第二检测装置，用于通过计算与当前内插取样在相同水平位置上的当前场的前一行和下一行中的取样之间的差来检测垂直相关；和第三检测装置，用于通过计算第一取样和第二取样的和与在相同水平位置上的当前场的前一行和下一行中的取样的和之间的差来检测时间垂直相关。
US10533994B2 CLAIM 9. The system of claim 8 , wherein the assay assembly comprises a reagent chamber (包括步骤) in fluidic communication with the reaction site, wherein the reagent chamber is configured to store an assay reagent.	CN1173776A CLAIM 14.根据权利要求13所述的隔行向顺序转换方法，其中所述步骤(c)包括步骤 (reagent chamber) ：(c1)检测第一取样组与第二取样组之间的运动相关，该第一取样组在包括与当前内插取样相同的位置上的第一取样、在该第一取样之前的取样和在该第一取样之后的取样及在前一行和后一行中与第一取样相同水平位置上的取样的前一场中，该第二取样组在包括与当前内插取样相同的位置上的第二取样、第二取样之前的取样和第二取样之后的取样和在前一行和后一行中与第二取样在相同水平位置上的取样的下一场中；(c2)通过计算与当前内插取样在相同水平位置上的当前场的前一行和下一行中的取样之间的差来检测垂直相关；(c3)通过计算第一取样和第二取样的和与在相同水平位置上的当前场的前一行和下一行中的取样的和之间的差来检测时间垂直相关。
US10533994B2 CLAIM 10. The system of claim 1 , wherein the reaction site of the assay assembly is in fluidic communication with the sample collection unit, the reaction site containing a reactant that reacts with the analyte to yield a signal indicative of the presence of the analyte; and the assay assembly further comprises: a reagent chamber (包括步骤) in fluidic communication with the reaction site, wherein the reagent chamber is configured to store an assay reagent; a fluidic channel connecting the reagent chamber with the reaction site; and an actuatable valve assembly configured to control the flow of reagent through the fluidic channel, wherein the valve assembly comprises a sealing element and actuator element, wherein the channel comprises first and second locations, wherein the sealing element positioned in the first location obstructs the flow of fluid through the channel and the sealing element positioned in the second location allows the flow of fluid through the channel, and wherein the actuator element is adapted to move the sealing element from the first location to the second location.	CN1173776A CLAIM 14.根据权利要求13所述的隔行向顺序转换方法，其中所述步骤(c)包括步骤 (reagent chamber) ：(c1)检测第一取样组与第二取样组之间的运动相关，该第一取样组在包括与当前内插取样相同的位置上的第一取样、在该第一取样之前的取样和在该第一取样之后的取样及在前一行和后一行中与第一取样相同水平位置上的取样的前一场中，该第二取样组在包括与当前内插取样相同的位置上的第二取样、第二取样之前的取样和第二取样之后的取样和在前一行和后一行中与第二取样在相同水平位置上的取样的下一场中；(c2)通过计算与当前内插取样在相同水平位置上的当前场的前一行和下一行中的取样之间的差来检测垂直相关；(c3)通过计算第一取样和第二取样的和与在相同水平位置上的当前场的前一行和下一行中的取样的和之间的差来检测时间垂直相关。

US10533994B2 Filed: 2006-03-24     Issued: 2020-01-14 Systems and methods of sample processing and fluid control in a fluidic system (Original Assignee) Theranos IP Co LLC     (Current Assignee) Theranos IP Co LLC Elizabeth A. Holmes, Shaunak Roy, Ian Gibbons, Shize Daniel Qi, Edmond Ku, Chris Todd, Melissa Takahashi, Bruce Johnson, Jeff Fenton, Keith Moravick, Uwe Springborn, Anthony Delacruz	EP0640826A1 Filed: 1994-08-16     Issued: 1995-03-01 System for detecting bacterial growth in a plurality of culture vials (Original Assignee) Becton Dickinson and Co     (Current Assignee) Becton Dickinson and Co Klaus W. Berndt
US10533994B2 CLAIM 10. The system of claim 1 , wherein the reaction site of the assay assembly is in fluidic communication with the sample collection unit, the reaction site containing a reactant that reacts with the analyte to yield a signal indicative of the presence of the analyte; and the assay assembly further comprises: a reagent chamber in fluidic communication with the reaction site, wherein the reagent chamber is configured to store an assay reagent; a fluidic channel connecting the reagent chamber with the reaction site; and an actuatable valve assembly configured to control the flow of reagent through the fluidic channel, wherein the valve assembly comprises a sealing element and actuator element, wherein the channel comprises first and second locations, wherein the sealing element positioned in the first location (first location) obstructs the flow of fluid through the channel and the sealing element positioned in the second location (second location) allows the flow of fluid through the channel, and wherein the actuator element is adapted to move the sealing element from the first location to the second location.	EP0640826A1 CLAIM 9 A method as recited in claim 8, further, including the steps of providing said test station with a first light radiation source at a first location (first location) , a detector at a second location (second location) spaced from said first location by a first distance, and a pair of light stubs being spaced by a distance which approximates said first distance and positioned adjacent to each of said vials, and directing said radiation source into one of said stubs, and the other of said stubs directing a reflected radiation out of the sample vial and into said detector to provide a first type of information with regard to whether the sample vial is experiencing bacterial growth.
US10533994B2 CLAIM 13. The system of claim 10 , wherein the second location (second location) has a larger cross section than the first location.	EP0640826A1 CLAIM 9 A method as recited in claim 8, further, including the steps of providing said test station with a first light radiation source at a first location, a detector at a second location (second location) spaced from said first location by a first distance, and a pair of light stubs being spaced by a distance which approximates said first distance and positioned adjacent to each of said vials, and directing said radiation source into one of said stubs, and the other of said stubs directing a reflected radiation out of the sample vial and into said detector to provide a first type of information with regard to whether the sample vial is experiencing bacterial growth.

US10533994B2 Filed: 2006-03-24     Issued: 2020-01-14 Systems and methods of sample processing and fluid control in a fluidic system (Original Assignee) Theranos IP Co LLC     (Current Assignee) Theranos IP Co LLC Elizabeth A. Holmes, Shaunak Roy, Ian Gibbons, Shize Daniel Qi, Edmond Ku, Chris Todd, Melissa Takahashi, Bruce Johnson, Jeff Fenton, Keith Moravick, Uwe Springborn, Anthony Delacruz	EP0639223A1 Filed: 1993-04-29     Issued: 1995-02-22 Microfabricated sperm handling devices. (Original Assignee) University of Pennsylvania     (Current Assignee) University of Pennsylvania Larry J Kricka, Peter Wilding
US10533994B2 CLAIM 1. A system for detecting the presence or absence of an analyte in a bodily fluid sample obtained from a subject, comprising: a cartridge, comprising: a sample collection unit, comprising: a sample collection well configured to receive a portion of the sample; a metering channel in fluid communication (fluid communication) with the sample collection well and configured such that the sample flows from the sample collection well into the metering channel; and a metering element comprising a mechanically movable portion configured to be movable from an open position that permits fluid communication between the sample collection well and the metering channel to a closed position that does not provide fluid communication between the sample collection well, thereby isolating a specific volume of the sample in the metering channel; a lysing assembly configured to lyse cells present in the sample; and an assay assembly comprising a reaction site containing a reactant able to react with the analyte to yield a detectable signal indicative of the presence or absence of the analyte; and a reader assembly comprising: a detection assembly configured to detect the signal; and a communication assembly configured to receive an assay protocol in response to receiving an identity of the cartridge from an external device, the external device being separate from the reader assembly, the communication assembly further configured to transmit the signal to the external device.	EP0639223A1 CLAIM 19. The device of claim 18, wherein said secondary channels comprise a fractal region, in fluid communication (fluid communication) with said primary flow channel, comprising equal numbers of bifurcations and junctions disposed serially along said region.
US10533994B2 CLAIM 14. The system of claim 10 , wherein the actuator element comprises a sealing member (said holding means) such that when the actuator element moves the sealing element the sealing member forms a substantially air tight seal such that the fluid can only flow through the channel.	EP0639223A1 CLAIM 22. The device of claim 1 or 17, further comprising an appliance for use in combination with said substrate, said appliance comprising: means for holding said substrate; fluid input means interfitting with an inlet port on said substrate; and pump means for delivering fluid to the flow system of said substrate when it is held in said holding means (sealing member) .
US10533994B2 CLAIM 15. The system of claim 14 wherein the actuator element is substantially pin shaped and the sealing member (said holding means) is an O-ring adapted to be placed around the actuator element.	EP0639223A1 CLAIM 22. The device of claim 1 or 17, further comprising an appliance for use in combination with said substrate, said appliance comprising: means for holding said substrate; fluid input means interfitting with an inlet port on said substrate; and pump means for delivering fluid to the flow system of said substrate when it is held in said holding means (sealing member) .

US10533994B2 Filed: 2006-03-24     Issued: 2020-01-14 Systems and methods of sample processing and fluid control in a fluidic system (Original Assignee) Theranos IP Co LLC     (Current Assignee) Theranos IP Co LLC Elizabeth A. Holmes, Shaunak Roy, Ian Gibbons, Shize Daniel Qi, Edmond Ku, Chris Todd, Melissa Takahashi, Bruce Johnson, Jeff Fenton, Keith Moravick, Uwe Springborn, Anthony Delacruz	EP0541340A2 Filed: 1992-11-03     Issued: 1993-05-12 Biopolymer synthesis apparatus and method (Original Assignee) Perkin Elmer Corp; Applied Biosystems Inc     (Current Assignee) Applera Corp David H. Lloyd, Robert J. Defranco, Charles S. Ladd
US10533994B2 CLAIM 14. The system of claim 10 , wherein the actuator element comprises a sealing member such that when the actuator element moves the sealing element the sealing member forms a substantially air tight seal (tight seal) such that the fluid can only flow through the channel.	EP0541340A2 CLAIM 3 The method of claim 1, wherein said adding includes engaging the port means of said cartridge with fitting means for forming a fluid tight seal (tight seal) about said port means, supplying said organic solvent into the cartridge chamber through said port means, and removing said polymer subunit solution from the cartridge chamber through said port means.

US10533994B2 Filed: 2006-03-24     Issued: 2020-01-14 Systems and methods of sample processing and fluid control in a fluidic system (Original Assignee) Theranos IP Co LLC     (Current Assignee) Theranos IP Co LLC Elizabeth A. Holmes, Shaunak Roy, Ian Gibbons, Shize Daniel Qi, Edmond Ku, Chris Todd, Melissa Takahashi, Bruce Johnson, Jeff Fenton, Keith Moravick, Uwe Springborn, Anthony Delacruz	CN1526074A Filed: 2002-05-09     Issued: 2004-09-01 检测系统 (Original Assignee) 阿克西斯-希尔德公司      乔斯坦・霍尔特伦德, 乔斯坦·霍尔特伦德, ・M・博尔奇, 施蒂格·M·博尔奇, 坦・塞姆, 索尔斯坦·塞姆, 詹森, 托尔·詹森, 托恩, 赫格·托恩, たǘ森, 简·R·卡尔森, L・劳夫斯塔德, 英格·L·劳夫斯塔德
US10533994B2 CLAIM 1. A system for detecting the presence or absence of an analyte in a bodily fluid sample (生物样本) obtained from a subject, comprising: a cartridge, comprising: a sample collection unit, comprising: a sample collection well configured to receive a portion of the sample; a metering channel in fluid communication with the sample collection well and configured such that the sample flows from the sample collection well into the metering channel; and a metering element comprising a mechanically movable portion configured to be movable from an open position that permits fluid communication (一光源) between the sample collection well and the metering channel to a closed position that does not provide fluid communication between the sample collection well, thereby isolating a specific volume of the sample in the metering channel; a lysing assembly configured to lyse cells present in the sample; and an assay assembly comprising a reaction site containing a reactant able to react with the analyte to yield a detectable signal indicative of the presence or absence of the analyte; and a reader assembly comprising: a detection assembly configured to detect the signal; and a communication assembly configured to receive an assay protocol in response to receiving an identity of the cartridge from an external device, the external device being separate from the reader assembly, the communication assembly further configured to transmit the signal to the external device.	CN1526074A CLAIM 38.按照权利要求36和37二者中任何一项所述的一种装置，还包括一光源 (permits fluid communication) ，用以照射所述检测盒。 CN1526074A CLAIM 45.按照权利要求1至20中任何一项所述的装置用于对一种生物样本 (bodily fluid sample) 中的某一被分析物或一生物样本的某一性质进行检测。
US10533994B2 CLAIM 14. The system of claim 10 , wherein the actuator element comprises a sealing member (的密封) such that when the actuator element moves the sealing element the sealing member forms a substantially air tight seal such that the fluid can only flow through the channel.	CN1526074A CLAIM 10.按照权利要求8和9二者之中任何一项所述的装置，其中至少一个所述插孔在其上端处由一易破裂的密封 (sealing member) 件予以密封，以及其中所述盒盖构件配有一割刀，用以刺穿所述密封件。
US10533994B2 CLAIM 15. The system of claim 14 wherein the actuator element is substantially pin shaped and the sealing member (的密封) is an O-ring adapted to be placed around the actuator element.	CN1526074A CLAIM 10.按照权利要求8和9二者之中任何一项所述的装置，其中至少一个所述插孔在其上端处由一易破裂的密封 (sealing member) 件予以密封，以及其中所述盒盖构件配有一割刀，用以刺穿所述密封件。

US10533994B2 Filed: 2006-03-24     Issued: 2020-01-14 Systems and methods of sample processing and fluid control in a fluidic system (Original Assignee) Theranos IP Co LLC     (Current Assignee) Theranos IP Co LLC Elizabeth A. Holmes, Shaunak Roy, Ian Gibbons, Shize Daniel Qi, Edmond Ku, Chris Todd, Melissa Takahashi, Bruce Johnson, Jeff Fenton, Keith Moravick, Uwe Springborn, Anthony Delacruz

EP0723146A1 Filed: 1993-09-14     Issued: 1996-07-24 Up-converting reporters for biological and other assays using laser excitation techniques (Original Assignee) SRI International     (Current Assignee) SRI International designation of the inventor has not yet been filed The

US10533994B2 CLAIM 1. A system for detecting the presence or absence of an analyte in a bodily fluid sample obtained from a subject, comprising: a cartridge, comprising: a sample collection unit, comprising: a sample collection well configured to receive a portion of the sample; a metering channel in fluid communication (second electrical signal) with the sample collection well and configured such that the sample flows from the sample collection well into the metering channel; and a metering element comprising a mechanically movable portion configured to be movable from an open position that permits fluid communication between the sample collection well and the metering channel to a closed position that does not provide fluid communication between the sample collection well, thereby isolating a specific volume of the sample in the metering channel; a lysing assembly configured to lyse cells present in the sample; and an assay assembly comprising a reaction site containing a reactant able to react with the analyte to yield a detectable signal indicative of the presence or absence of the analyte; and a reader assembly comprising: a detection assembly configured to detect the signal; and a communication assembly configured to receive an assay protocol in response to receiving an identity of the cartridge from an external device, the external device being separate from the reader assembly, the communication assembly further configured to transmit the signal to the external device.

EP0723146A1 CLAIM 5 Apparatus for analysing a sample possible containing first and second up-converting luminescent reporters, wherein the first reporter is characterised by an excitation band in a first range of wavelengths and an emission band in a second range of wavelengths that are shorter than the wavelengths in the first range, wherein the second reporter is characterised by an excitation band in a third range of wavelengths and an emission band in a fourth range of wavelengths, and wherein the first and third ranges do not overlap and the second and fourth ranges overlap, the apparatus comprising:    a first source capable of emitting light in a range of wavelengths that overlaps with at least a portion of the excitation band of the first reporter;    a second source capable of emitting light in a range of wavelengths that overlaps with a least a portion of the excitation band of the second reporter;    means for energizing said first and second sources including means for imposing different intensity patterns on said first-mentioned and second sources;    means for directing at least a portion of the light emitted by said first and second sources to a location at the sample, including light in the first and third ranges of wavelengths and excluding light in the second and fourth ranges of wavelengths; and    means, coupled to said detector, for generating first and second electrical signal (fluid communication) s representative of the respective intensities of light incident on said detector at wavelengths in the second and fourth ranges and outside the first and third ranges, including means for distinguishing said different intensity patterns.

US10533994B2 Filed: 2006-03-24     Issued: 2020-01-14 Systems and methods of sample processing and fluid control in a fluidic system (Original Assignee) Theranos IP Co LLC     (Current Assignee) Theranos IP Co LLC Elizabeth A. Holmes, Shaunak Roy, Ian Gibbons, Shize Daniel Qi, Edmond Ku, Chris Todd, Melissa Takahashi, Bruce Johnson, Jeff Fenton, Keith Moravick, Uwe Springborn, Anthony Delacruz	EP0693560A2 Filed: 1995-07-18     Issued: 1996-01-24 Method and apparatus for fully automated nucleic acid amplification, nucleic acid assay and immunoassay (Original Assignee) Becton Dickinson and Co     (Current Assignee) Becton Dickinson and Co Hugh V. Cottingham
US10533994B2 CLAIM 1. A system for detecting the presence or absence of an analyte in a bodily fluid sample obtained from a subject, comprising: a cartridge, comprising: a sample collection unit, comprising: a sample collection well configured to receive a portion of the sample; a metering channel in fluid communication with the sample collection well and configured such that the sample flows from the sample collection well into the metering channel; and a metering element comprising a mechanically movable portion configured to be movable from an open position (open position) that permits fluid communication between the sample collection well and the metering channel to a closed position that does not provide fluid communication between the sample collection well, thereby isolating a specific volume of the sample in the metering channel; a lysing assembly configured to lyse cells present in the sample; and an assay assembly comprising a reaction site containing a reactant able to react with the analyte to yield a detectable signal indicative of the presence or absence of the analyte; and a reader assembly comprising: a detection assembly configured to detect the signal; and a communication assembly configured to receive an assay protocol in response to receiving an identity of the cartridge from an external device, the external device being separate from the reader assembly, the communication assembly further configured to transmit the signal to the external device.	EP0693560A2 CLAIM 5 A test unit as claimed in claim 1 or 2, wherein said sample chamber is provided with an opening for allowing said liquid biological sample to be introduced into said sample chamber, and wherein said closure is movable from an open position (open position) to a closed position to seal said opening after said liquid biological sample has been introduced.
US10533994B2 CLAIM 3. The system of claim 2 , wherein the pin is configured to be movable from an open position (open position) to a closed position, wherein the pin in the closed position blocks the metering channel.	EP0693560A2 CLAIM 5 A test unit as claimed in claim 1 or 2, wherein said sample chamber is provided with an opening for allowing said liquid biological sample to be introduced into said sample chamber, and wherein said closure is movable from an open position (open position) to a closed position to seal said opening after said liquid biological sample has been introduced.
US10533994B2 CLAIM 9. The system of claim 8 , wherein the assay assembly comprises a reagent chamber (reagent chamber) in fluidic communication with the reaction site, wherein the reagent chamber is configured to store an assay reagent.	EP0693560A2 CLAIM 6 A test unit as claimed in claim 1 or 2, further comprising    at least one reagent chamber (reagent chamber) for containing a liquid reagent; and    a second liquid flow path between said reagent chamber and said first liquid flow path.
US10533994B2 CLAIM 10. The system of claim 1 , wherein the reaction site of the assay assembly is in fluidic communication with the sample collection unit, the reaction site containing a reactant that reacts with the analyte to yield a signal indicative of the presence of the analyte; and the assay assembly further comprises: a reagent chamber (reagent chamber) in fluidic communication with the reaction site, wherein the reagent chamber is configured to store an assay reagent; a fluidic channel connecting the reagent chamber with the reaction site; and an actuatable valve assembly configured to control the flow of reagent through the fluidic channel, wherein the valve assembly comprises a sealing element and actuator element, wherein the channel comprises first and second locations, wherein the sealing element positioned in the first location obstructs the flow of fluid through the channel and the sealing element positioned in the second location allows the flow of fluid through the channel, and wherein the actuator element is adapted to move the sealing element from the first location to the second location.	EP0693560A2 CLAIM 6 A test unit as claimed in claim 1 or 2, further comprising    at least one reagent chamber (reagent chamber) for containing a liquid reagent; and    a second liquid flow path between said reagent chamber and said first liquid flow path.

US10533994B2 Filed: 2006-03-24     Issued: 2020-01-14 Systems and methods of sample processing and fluid control in a fluidic system (Original Assignee) Theranos IP Co LLC     (Current Assignee) Theranos IP Co LLC Elizabeth A. Holmes, Shaunak Roy, Ian Gibbons, Shize Daniel Qi, Edmond Ku, Chris Todd, Melissa Takahashi, Bruce Johnson, Jeff Fenton, Keith Moravick, Uwe Springborn, Anthony Delacruz

JPH0727700A Filed: 1993-07-14     Issued: 1995-01-31 光学式成分濃度測定装置および方法 (Original Assignee) Kyoto Daiichi Kagaku:Kk; 株式会社京都第一科学      Kakin Jiyo, Takeshi Sakura, Seizo Uenoyama, Yutaka Yamazaki, 晴三 上野山, 武司 佐倉, 豊 山崎, 可欣 徐

US10533994B2 CLAIM 1. A system for detecting the presence or absence of an analyte in a bodily fluid sample obtained from a subject, comprising: a cartridge, comprising: a sample collection unit, comprising: a sample collection well configured to receive a portion of the sample; a metering channel in fluid communication with the sample collection well and configured such that the sample flows from the sample collection well into the metering channel; and a metering element comprising a mechanically movable portion configured to be movable from an open position that permits fluid communication between the sample collection well and the metering channel to a closed position that does not provide fluid communication between the sample collection well, thereby isolating a specific volume of the sample in the metering channel; a lysing assembly configured to lyse cells present in the sample; and an assay assembly comprising a reaction site containing a reactant able to react with the analyte to yield a detectable signal indicative of the presence or absence of the analyte; and a reader assembly comprising: a detection assembly (検出手段, 受光部) configured to detect the signal; and a communication assembly configured to receive an assay protocol in response to receiving an identity of the cartridge from an external device, the external device being separate from the reader assembly, the communication assembly further configured to transmit the signal to the external device.

JPH0727700A CLAIM 1 【請求項１】 試料を収容し、内部の光路長を異ならせ ることが可能なセルと、このセルに対して選択された波 長の光を照射するとともに、この照射する光の波長を変 え得る光照射部と、上記セルを透過した光を受け、この 透過光量を検出する受光部 (detection assembly) と、この受光部で検出した透 過光量に対する光量測定感度のピーク値が生じるときの 光路長を波長毎に算出、記憶し、この波長毎に記憶した ピーク位置での透過光量値、光路長の値に基づいて上記 試料中の成分の濃度を算出し、算出結果を出力する演算 部とからなる光学式成分濃度測定装置。 JPH0727700A CLAIM 9 【請求項９】 上記受光部が選択された光を受けて光量 を検出する光量検出手段 (detection assembly) を備えたことを特徴とする請求 項１から８のいずれかに記載の光学式成分濃度測定装 置。

US10533994B2 Filed: 2006-03-24     Issued: 2020-01-14 Systems and methods of sample processing and fluid control in a fluidic system (Original Assignee) Theranos IP Co LLC     (Current Assignee) Theranos IP Co LLC Elizabeth A. Holmes, Shaunak Roy, Ian Gibbons, Shize Daniel Qi, Edmond Ku, Chris Todd, Melissa Takahashi, Bruce Johnson, Jeff Fenton, Keith Moravick, Uwe Springborn, Anthony Delacruz	EP0576602A1 Filed: 1992-02-18     Issued: 1994-01-05 A device and a method for separating liquid samples. (Original Assignee) 3M Co     (Current Assignee) DIAGEN INSTITUT FUER MOLEKULARBIOLOGISCHE DIAGNOS ; 3M Co James E Aysta, Metin Colpan
US10533994B2 CLAIM 14. The system of claim 10 , wherein the actuator element comprises a sealing member such that when the actuator element moves the sealing element the sealing member forms a substantially air tight seal (tight seal) such that the fluid can only flow through the channel.

US10533994B2 Filed: 2006-03-24     Issued: 2020-01-14 Systems and methods of sample processing and fluid control in a fluidic system (Original Assignee) Theranos IP Co LLC     (Current Assignee) Theranos IP Co LLC Elizabeth A. Holmes, Shaunak Roy, Ian Gibbons, Shize Daniel Qi, Edmond Ku, Chris Todd, Melissa Takahashi, Bruce Johnson, Jeff Fenton, Keith Moravick, Uwe Springborn, Anthony Delacruz	CN1173776C Filed: 1997-06-24     Issued: 2004-11-03 在微规模流体性设备里的高通过量的筛选分析系统 (Original Assignee) 卡钳技术有限公司      J・W・帕斯, J·W·帕斯, 克普夫-西尔, A·R·克普夫－西尔, 布塞, L·J·布塞
US10533994B2 CLAIM 1. A system for detecting the presence or absence of an analyte in a bodily fluid (系统一起, 第一横) sample obtained from a subject, comprising: a cartridge, comprising: a sample collection unit, comprising: a sample collection well configured to receive a portion of the sample; a metering channel (包括通过) in fluid communication (微流体装置, 体系统) with the sample collection well and configured such that the sample flows from the sample collection well into the metering channel; and a metering element comprising a mechanically movable portion configured to be movable from an open position that permits fluid communication between the sample collection well and the metering channel to a closed position that does not provide fluid communication between the sample collection well, thereby isolating a specific volume of the sample in the metering channel; a lysing assembly configured to lyse cells present in the sample; and an assay assembly comprising a reaction site (一点处) containing a reactant able to react with the analyte to yield a detectable signal indicative of the presence or absence of the analyte; and a reader assembly comprising: a detection assembly (或多个) configured to detect the signal; and a communication assembly configured to receive an assay protocol in response to receiving an identity of the cartridge from an external device, the external device being separate from the reader assembly, the communication assembly further configured to transmit the signal to the external device.	CN1173776C CLAIM 18.根据权利要求1所述的装置，该装置进一步包括在多个贮槽中的多个电极，所述的贮槽与所述相交管的一个管或多个 (detection assembly) 管以流体连接，和用于同时对每个所述电极施加电压的控制系统，从而控制所述第一组分在所述至少两个相交管中的运动。 CN1173776C CLAIM 23.根据权利要求21所述的装置，其中所述多个反应管的每个反应管在所述多个反应管的第一点处 (reaction site) 包含珠停留井。 CN1173776C CLAIM 42.一种测定样品是否含能影响生化系统的化合物的方法，包括：提供包括有至少两个相交管组装在其中的主体结构的微流体装置 (fluid communication) ，所述至少两个相交管中的至少一个管子的至少一个截面尺寸范围为0.1-500微米；将生化系统的第一组分流入所述至少两个相交管的第一管中；将所述样品从第二管流入所述第一管，从而所述样品与所述生化系统的第一组分接触；和检测所述至少一种样品对所述生化系统的作用。 CN1173776C CLAIM 61.根据权利要求60所述的方法，其中所述细胞能产生相应于细胞功能的可检测信号，所述的检测步骤包括通过 (metering channel) 检测所述可检测信号的水平来测定所述试验化合物对所述细胞功能的作用。 CN1173776C CLAIM 87.根据权利要求75所述的方法，其中多个不同试验化合物的每个试验化合物在分开的珠上固定，使每个所述多个不同试验化合物导向进入所述多个反应管的各个分开管的步骤包括：将所述分开珠的一个装载到所述第一横 (bodily fluid, bodily fluid sample) 向管与所述多个反应管的每个反应管的交叉处；和可控制地将来自每个所述分开珠的所述试验化合物释放入每个所述多个反应管里。 CN1173776C CLAIM 88.含至少第一基片的微流体系统 (fluid communication) 的用途，所述第一基片有第一管和与所述第一管相交的第二管，所述管的至少一个的至少一个截面尺寸为0.1-500微米，以便试验多个试验化合物对生化系统的作用。 CN1173776C CLAIM 92.携带相交管的基片在筛选试验材料对生化系统的作用中的用途，它通过使用所述管子使所述试验化合物和生化系统一起 (bodily fluid, bodily fluid sample) 流动。
US10533994B2 CLAIM 4. The system of claim 2 , wherein the sample collection unit (的样品) further comprises: a dilution chamber in fluidic communication with the metering channel, wherein the dilution chamber is configured to store a diluent and comprises a port engaging pressure means (施加电) transferring the diluent from the dilution chamber into the metering channel.	CN1173776C CLAIM 18.根据权利要求1所述的装置，该装置进一步包括在多个贮槽中的多个电极，所述的贮槽与所述相交管的一个管或多个管以流体连接，和用于同时对每个所述电极施加电 (port engaging pressure means) 压的控制系统，从而控制所述第一组分在所述至少两个相交管中的运动。 CN1173776C CLAIM 50.根据权利要求42所述的方法，其中所述检测步骤包括在有或没有所述样品存在下测量所述生化系统的参数，并将在有所述样品存在下测得的参数与在没有所述样品存在下测得的参数进行比较，所述参数的改变表示所述的样品 (sample collection unit) 对所述生化系统有作用。
US10533994B2 CLAIM 5. The system of claim 4 , wherein the sample collection unit (的样品) further comprises a mixing chamber in fluidic communication with the metering channel, the mixing chamber being configured to mix the predetermined portion of the sample with the diluent to yield a diluted sample.	CN1173776C CLAIM 50.根据权利要求42所述的方法，其中所述检测步骤包括在有或没有所述样品存在下测量所述生化系统的参数，并将在有所述样品存在下测得的参数与在没有所述样品存在下测得的参数进行比较，所述参数的改变表示所述的样品 (sample collection unit) 对所述生化系统有作用。
US10533994B2 CLAIM 6. The system of claim 5 , wherein the sample collection unit (的样品) further comprises a filter configured to filter the diluted sample before it is assayed.	CN1173776C CLAIM 50.根据权利要求42所述的方法，其中所述检测步骤包括在有或没有所述样品存在下测量所述生化系统的参数，并将在有所述样品存在下测得的参数与在没有所述样品存在下测得的参数进行比较，所述参数的改变表示所述的样品 (sample collection unit) 对所述生化系统有作用。
US10533994B2 CLAIM 10. The system of claim 1 , wherein the reaction site (一点处) of the assay assembly is in fluidic communication with the sample collection unit, the reaction site containing a reactant that reacts with the analyte to yield a signal indicative of the presence of the analyte; and the assay assembly further comprises: a reagent chamber in fluidic communication with the reaction site, wherein the reagent chamber is configured to store an assay reagent; a fluidic channel connecting the reagent chamber with the reaction site; and an actuatable valve assembly configured to control the flow of reagent through the fluidic channel, wherein the valve assembly comprises a sealing element and actuator element, wherein the channel comprises first and second locations, wherein the sealing element positioned in the first location obstructs the flow of fluid through the channel and the sealing element positioned in the second location allows the flow of fluid through the channel, and wherein the actuator element is adapted to move the sealing element from the first location to the second location.	CN1173776C CLAIM 23.根据权利要求21所述的装置，其中所述多个反应管的每个反应管在所述多个反应管的第一点处 (reaction site) 包含珠停留井。
US10533994B2 CLAIM 17. The system of claim 10 , wherein the sample of bodily fluid (系统一起, 第一横) is less than 50 μl.	CN1173776C CLAIM 87.根据权利要求75所述的方法，其中多个不同试验化合物的每个试验化合物在分开的珠上固定，使每个所述多个不同试验化合物导向进入所述多个反应管的各个分开管的步骤包括：将所述分开珠的一个装载到所述第一横 (bodily fluid, bodily fluid sample) 向管与所述多个反应管的每个反应管的交叉处；和可控制地将来自每个所述分开珠的所述试验化合物释放入每个所述多个反应管里。 CN1173776C CLAIM 92.携带相交管的基片在筛选试验材料对生化系统的作用中的用途，它通过使用所述管子使所述试验化合物和生化系统一起 (bodily fluid, bodily fluid sample) 流动。

US10533994B2 Filed: 2006-03-24     Issued: 2020-01-14 Systems and methods of sample processing and fluid control in a fluidic system (Original Assignee) Theranos IP Co LLC     (Current Assignee) Theranos IP Co LLC Elizabeth A. Holmes, Shaunak Roy, Ian Gibbons, Shize Daniel Qi, Edmond Ku, Chris Todd, Melissa Takahashi, Bruce Johnson, Jeff Fenton, Keith Moravick, Uwe Springborn, Anthony Delacruz

JP2003315348A Filed: 2002-04-22     Issued: 2003-11-06 検体処理システム及びそれを用いた検体検査自動化システム (Original Assignee) Hitachi High-Technologies Corp; 株式会社日立ハイテクノロジーズ      Tatsutoshi Imaoka, Nobuo Suzuki, Hitoshi Tokieda, 龍勇 今岡, 仁 時枝, 信雄 鈴木

US10533994B2 CLAIM 1. A system for detecting the presence or absence of an analyte in a bodily fluid sample (前記生) obtained from a subject, comprising: a cartridge, comprising: a sample collection unit, comprising: a sample collection well configured to receive a portion of the sample; a metering channel in fluid communication with the sample collection well and configured such that the sample flows from the sample collection well into the metering channel; and a metering element comprising a mechanically movable portion configured to be movable from an open position that permits fluid communication between the sample collection well and the metering channel to a closed position that does not provide fluid communication between the sample collection well, thereby isolating a specific volume of the sample in the metering channel; a lysing assembly configured to lyse cells present in the sample; and an assay assembly comprising a reaction site containing a reactant able to react with the analyte to yield a detectable signal indicative of the presence or absence of the analyte; and a reader assembly comprising: a detection assembly configured to detect the signal; and a communication assembly configured to receive an assay protocol in response to receiving an identity of the cartridge from an external device, the external device being separate from the reader assembly, the communication assembly further configured to transmit the signal to the external device.

JP2003315348A CLAIM 1 【特許請求の範囲】 【請求項１】採取された生体サンプルを収容する生体サ ンプル収容容器と、 前記生 (bodily fluid sample) 体サンプル収容容器に収容された生体サンプルを 処理して、分析装置での分析が可能な被検査サンプルを 生成する、少なくとも遠心分離処理を含む前処理手段 と、 前記前処理手段で生成された被検査サンプルの量を測定 する被検査サンプル量測定手段と、 被検査サンプルの検査項目及び該検査項目の分析に必要 な被検査サンプルの量を記憶する検査項目記憶手段と、 該検査項目の検査優先度を記憶する優先度記憶手段と、 前記被検査サンプル量測定手段により測定された被検査 サンプル量と、前記検査項目記憶手段に記憶された検査 項目及び該検査項目の分析に必要な被検査サンプルの量 から算出された被検査サンプルの分析に必要な被検査サ ンプル量とを比較する比較手段と、 前記比較手段での比較の結果、被検査サンプル量が必要 な被検査サンプル量に比べ少ない場合は、該被検査サン プルに対して記憶された検査項目の優先度に従い前記被 検査サンプル量で測定が可能な検査項目を選択する検査 項目選択手段と、 前記検査項目選択手段で選択された検査項目の分析に必 要な被検査サンプルの量を、被検査サンプルを収容する 被検査サンプル収容容器に分注する分注手段と、を備え たことを特徴とする検体処理システム。 【請求項２】請求項１記載の検体処理システムにおい て、 同一の前記生体サンプル収容容器に収容されている生体 サンプルから、複数の被検査サンプル収容容器にサンプ ルが分注される機能を備えたことを特徴とする検体処理 システム。 【請求項３】請求項２記載の検体処理システムにおい て、 前記被検査サンプルの分析を行う複数の分析装置がある 場合、該複数の分析装置ごとに、異なる被検査サンプル 収容容器に分注する機能を備えたことを特徴とする検体 処理システム。 【請求項４】請求項１〜３のいずれかに記載の検体処理 システムに、搬送ラインを介して自動分析装置が接続さ れ、前記分注された被検査サンプルが前記搬送ラインを 介して前記分析装置へと搬送され、分析が行われる機構 を備えたことを特徴とする検体検査自動化システム。 【請求項５】請求項４記載の検体検査自動化システムに おいて、 前記搬送ラインは前記検体処理システムの中央制御部に て制御されるものであって、前記被検査サンプル量測定 手段での測定結果に基づき優先的に分注された被検査サ ンプルの分注結果に基づき、該被検査サンプルが架設さ れているラックの搬送先を制御する機構を備えたことを 特徴とする検体検査自動化システム。

US10533994B2 Filed: 2006-03-24     Issued: 2020-01-14 Systems and methods of sample processing and fluid control in a fluidic system (Original Assignee) Theranos IP Co LLC     (Current Assignee) Theranos IP Co LLC Elizabeth A. Holmes, Shaunak Roy, Ian Gibbons, Shize Daniel Qi, Edmond Ku, Chris Todd, Melissa Takahashi, Bruce Johnson, Jeff Fenton, Keith Moravick, Uwe Springborn, Anthony Delacruz	CN1746675A Filed: 2004-09-07     Issued: 2006-03-15 免疫层析测试条及其制造方法 (Original Assignee) 李人      李人, 杨立邦, 申勇
US10533994B2 CLAIM 4. The system of claim 2 , wherein the sample collection unit (的样品) further comprises: a dilution chamber in fluidic communication with the metering channel, wherein the dilution chamber is configured to store a diluent and comprises a port engaging pressure means transferring the diluent from the dilution chamber into the metering channel.	CN1746675A CLAIM 4.如权利要求3所述免疫层析测试条，其特征在于：所述的样品 (sample collection unit) 膜(4)和胶体金标记膜(6)为玻璃纤维膜。
US10533994B2 CLAIM 5. The system of claim 4 , wherein the sample collection unit (的样品) further comprises a mixing chamber in fluidic communication with the metering channel, the mixing chamber being configured to mix the predetermined portion of the sample with the diluent to yield a diluted sample.	CN1746675A CLAIM 4.如权利要求3所述免疫层析测试条，其特征在于：所述的样品 (sample collection unit) 膜(4)和胶体金标记膜(6)为玻璃纤维膜。
US10533994B2 CLAIM 6. The system of claim 5 , wherein the sample collection unit (的样品) further comprises a filter configured to filter the diluted sample before it is assayed.	CN1746675A CLAIM 4.如权利要求3所述免疫层析测试条，其特征在于：所述的样品 (sample collection unit) 膜(4)和胶体金标记膜(6)为玻璃纤维膜。

US10533994B2 Filed: 2006-03-24     Issued: 2020-01-14 Systems and methods of sample processing and fluid control in a fluidic system (Original Assignee) Theranos IP Co LLC     (Current Assignee) Theranos IP Co LLC Elizabeth A. Holmes, Shaunak Roy, Ian Gibbons, Shize Daniel Qi, Edmond Ku, Chris Todd, Melissa Takahashi, Bruce Johnson, Jeff Fenton, Keith Moravick, Uwe Springborn, Anthony Delacruz

JP2005104750A Filed: 2003-09-29     Issued: 2005-04-21 ナノチューブの精製方法 (Original Assignee) Matsushita Electric Ind Co Ltd; 松下電器産業株式会社      Hisahide Wakita, 尚英 脇田

US10533994B2 CLAIM 1. A system for detecting the presence or absence of an analyte in a bodily fluid sample obtained from a subject, comprising: a cartridge, comprising: a sample collection unit, comprising: a sample collection well configured to receive a portion of the sample; a metering channel in fluid communication with the sample collection well and configured such that the sample flows from the sample collection well into the metering channel; and a metering element comprising a mechanically movable portion configured to be movable from an open position that permits fluid communication between the sample collection well and the metering channel to a closed position that does not provide fluid communication between the sample collection well, thereby isolating a specific volume of the sample in the metering channel; a lysing assembly configured to lyse cells present in the sample; and an assay assembly comprising a reaction site containing a reactant able to react with the analyte to yield a detectable signal indicative of the presence or absence of the analyte; and a reader assembly comprising: a detection assembly configured to detect the signal; and a communication assembly (少なくとも１, 前記基) configured to receive an assay protocol in response to receiving an identity of the cartridge from an external device, the external device being separate from the reader assembly, the communication assembly further configured to transmit the signal to the external device.

JP2005104750A CLAIM 4 前記帯電処理工程が、前記ナノチューブ含有材料を接触帯電、コロナ放電および電子ビーム照射より選択された少なくとも１ (communication assembly) つの方法により帯電させる工程を有することを特徴とする請求項１から３のいずれかに記載のナノチューブの精製方法。 JP2005104750A CLAIM 8 前記材料分散工程は、前記ナノチューブ含有材料が電気絶縁性の基板上に分散される工程を含み、前記電界印加工程は、前記基 (communication assembly) 板と対向して設けた対向電極あるいは対向基板との間に電界を印加する工程を有することを特徴とする請求項１から７のいずれかに記載のナノチューブの精製方法。

US10533994B2 Filed: 2006-03-24     Issued: 2020-01-14 Systems and methods of sample processing and fluid control in a fluidic system (Original Assignee) Theranos IP Co LLC     (Current Assignee) Theranos IP Co LLC Elizabeth A. Holmes, Shaunak Roy, Ian Gibbons, Shize Daniel Qi, Edmond Ku, Chris Todd, Melissa Takahashi, Bruce Johnson, Jeff Fenton, Keith Moravick, Uwe Springborn, Anthony Delacruz	JP2005015243A Filed: 2003-06-23     Issued: 2005-01-20 高純度ナノスケールカーボンチューブ含有炭素質材料の製造法 (Original Assignee) Osaka Gas Co Ltd; 大阪瓦斯株式会社      Takeo Matsui, Haruyuki Nakaoka, Taisuke Yokomichi, 春雪 中岡, 丈雄 松井, 泰典 横道
US10533994B2 CLAIM 1. A system for detecting the presence or absence of an analyte in a bodily fluid sample obtained from a subject, comprising: a cartridge, comprising: a sample collection unit, comprising: a sample collection well configured to receive a portion of the sample; a metering channel in fluid communication with the sample collection well and configured such that the sample flows from the sample collection well into the metering channel; and a metering element comprising a mechanically movable portion configured to be movable from an open position (フレーク) that permits fluid communication between the sample collection well and the metering channel to a closed position that does not provide fluid communication between the sample collection well, thereby isolating a specific volume of the sample in the metering channel; a lysing assembly configured to lyse cells present in the sample; and an assay assembly comprising a reaction site containing a reactant able to react with the analyte to yield a detectable signal indicative of the presence or absence of the analyte; and a reader assembly comprising: a detection assembly (静電気) configured to detect the signal; and a communication assembly (少なくとも１) configured to receive an assay protocol in response to receiving an identity of the cartridge from an external device, the external device being separate from the reader assembly, the communication assembly further configured to transmit the signal to the external device.	JP2005015243A CLAIM 1 （ｉ）原料として使用するナノスケールカーボンチューブ含有炭素質材料と、静電気 (detection assembly) を帯びた基材とを接触又は接近させて、該原料ナノスケールカーボンチューブ含有炭素質材料中に含まれている不純物を基材表面に付着させる工程、及び （ｉｉ）該基材表面に付着しなかった高純度ナノスケールカーボンチューブ含有炭素質材料を回収する工程 を含むことを特徴とする高純度ナノスケールカーボンチューブ含有炭素質材料の製造法。 JP2005015243A CLAIM 2 ナノスケールカーボンチューブが、アモルファスナノスケールカーボンチューブ及び多層カーボンナノチューブからなる群から選ばれる少なくとも１ (communication assembly) 種である請求項１に記載の製造法。 JP2005015243A CLAIM 3 ナノスケールカーボンチューブが、（ａ）ナノフレーク (open position) カーボンチューブと、（ｂ）鉄又は炭化鉄とからなり、該ナノフレークカーボンチューブ（ａ）のチューブ内空間部の１０〜９０％の範囲に、該鉄又は炭化鉄（ｂ）が存在している鉄−炭素複合体である請求項１に記載の製造法。
US10533994B2 CLAIM 3. The system of claim 2 , wherein the pin is configured to be movable from an open position (フレーク) to a closed position, wherein the pin in the closed position blocks the metering channel.	JP2005015243A CLAIM 3 ナノスケールカーボンチューブが、（ａ）ナノフレーク (open position) カーボンチューブと、（ｂ）鉄又は炭化鉄とからなり、該ナノフレークカーボンチューブ（ａ）のチューブ内空間部の１０〜９０％の範囲に、該鉄又は炭化鉄（ｂ）が存在している鉄−炭素複合体である請求項１に記載の製造法。

US10533994B2 Filed: 2006-03-24     Issued: 2020-01-14 Systems and methods of sample processing and fluid control in a fluidic system (Original Assignee) Theranos IP Co LLC     (Current Assignee) Theranos IP Co LLC Elizabeth A. Holmes, Shaunak Roy, Ian Gibbons, Shize Daniel Qi, Edmond Ku, Chris Todd, Melissa Takahashi, Bruce Johnson, Jeff Fenton, Keith Moravick, Uwe Springborn, Anthony Delacruz

EP1360931A1 Filed: 2003-05-08     Issued: 2003-11-12 Physiological sample collection devices and method of using the same (Original Assignee) LifeScan Inc     (Current Assignee) LifeScan Inc Ernest Kiser, Koon-Wah Leong, Devin V. Mcallister, Lorin Olson, Maria Teodorczyk, Vadim V. Yuzhakov

US10533994B2 CLAIM 1. A system for detecting the presence or absence of an analyte in a bodily fluid sample obtained from a subject, comprising: a cartridge, comprising: a sample collection unit, comprising: a sample collection well configured to receive a portion of the sample; a metering channel in fluid communication (fluid communication) with the sample collection well and configured such that the sample flows from the sample collection well into the metering channel; and a metering element comprising a mechanically movable portion configured to be movable from an open position that permits fluid communication between the sample collection well and the metering channel to a closed position that does not provide fluid communication between the sample collection well, thereby isolating a specific volume of the sample in the metering channel; a lysing assembly configured to lyse cells present in the sample; and an assay assembly comprising a reaction site containing a reactant able to react with the analyte to yield a detectable signal indicative of the presence or absence of the analyte; and a reader assembly comprising: a detection assembly configured to detect the signal; and a communication assembly configured to receive an assay protocol in response to receiving an identity of the cartridge from an external device, the external device being separate from the reader assembly, the communication assembly further configured to transmit the signal to the external device.

EP1360931A1 CLAIM 1 A test strip device comprising: a biosensor for determining a characteristic of a physiological fluid; at least one microneedle integral with and extending from said biosensor; said microneedle comprising an opening which occupies a substantial portion of a width, diameter or length dimension of said microneedle; and a fluid pathway extending from said biosensor to said microneedle wherein said fluid pathway is in fluid communication (fluid communication) with said opening and said biosensor.

US10533994B2 Filed: 2006-03-24     Issued: 2020-01-14 Systems and methods of sample processing and fluid control in a fluidic system (Original Assignee) Theranos IP Co LLC     (Current Assignee) Theranos IP Co LLC Elizabeth A. Holmes, Shaunak Roy, Ian Gibbons, Shize Daniel Qi, Edmond Ku, Chris Todd, Melissa Takahashi, Bruce Johnson, Jeff Fenton, Keith Moravick, Uwe Springborn, Anthony Delacruz

EP1346686A2 Filed: 2003-02-24     Issued: 2003-09-24 Fluid collection apparatus having an integrated lancet and reaction area (Original Assignee) Bayer Healthcare LLC     (Current Assignee) Bayer Healthcare LLC Allen J. Brenneman

US10533994B2 CLAIM 1. A system for detecting the presence or absence of an analyte in a bodily fluid sample obtained from a subject, comprising: a cartridge, comprising: a sample collection unit, comprising: a sample collection well configured to receive a portion of the sample; a metering channel in fluid communication (fluid communication) with the sample collection well and configured such that the sample flows from the sample collection well into the metering channel; and a metering element comprising a mechanically movable portion configured to be movable from an open position that permits fluid communication between the sample collection well and the metering channel to a closed position that does not provide fluid communication between the sample collection well, thereby isolating a specific volume of the sample in the metering channel; a lysing assembly configured to lyse cells present in the sample; and an assay assembly comprising a reaction site containing a reactant able to react with the analyte to yield a detectable signal indicative of the presence or absence of the analyte; and a reader assembly comprising: a detection assembly configured to detect the signal; and a communication assembly configured to receive an assay protocol in response to receiving an identity of the cartridge from an external device, the external device being separate from the reader assembly, the communication assembly further configured to transmit the signal to the external device.

EP1346686A2 CLAIM 14 A fluid collection apparatus adapted to test a concentration of an analyte in a fluid comprising a lid and a body having a lance, a reaction area, and a transfer area in fluid communication (fluid communication) with the lance and reaction area, such that the reaction area, the transfer area, and the lance lie in the same plane and are a part of a single integrated structure, formed of a single sheet of material.

US10533994B2 Filed: 2006-03-24     Issued: 2020-01-14 Systems and methods of sample processing and fluid control in a fluidic system (Original Assignee) Theranos IP Co LLC     (Current Assignee) Theranos IP Co LLC Elizabeth A. Holmes, Shaunak Roy, Ian Gibbons, Shize Daniel Qi, Edmond Ku, Chris Todd, Melissa Takahashi, Bruce Johnson, Jeff Fenton, Keith Moravick, Uwe Springborn, Anthony Delacruz	JP2003222611A Filed: 2002-11-20     Issued: 2003-08-08 分離装置、分離方法および分離装置の製造方法 (Original Assignee) Nec Corp; 日本電気株式会社      Masakazu Baba, Noriyuki Iguchi, Kazuhiro Iida, Hisao Kawaura, Toshimori Sakamoto, Toru Sano, Hiroko Someya, 憲幸 井口, 亨 佐野, 久雄 川浦, 浩子 染谷, 利司 阪本, 一浩 飯田, 雅和 馬場
US10533994B2 CLAIM 1. A system for detecting the presence or absence of an analyte in a bodily fluid sample obtained from a subject, comprising: a cartridge, comprising: a sample collection unit, comprising: a sample collection well configured to receive a portion of the sample; a metering channel in fluid communication (１乃至６) with the sample collection well and configured such that the sample flows from the sample collection well into the metering channel; and a metering element (開口部) comprising a mechanically movable portion configured to be movable from an open position that permits fluid communication between the sample collection well and the metering channel to a closed position that does not provide fluid communication between the sample collection well, thereby isolating a specific volume of the sample in the metering channel; a lysing assembly configured to lyse cells present in the sample; and an assay assembly comprising a reaction site containing a reactant able to react with the analyte to yield a detectable signal indicative of the presence or absence of the analyte; and a reader assembly comprising: a detection assembly configured to detect the signal; and a communication assembly configured to receive an assay protocol in response to receiving an identity of the cartridge from an external device, the external device being separate from the reader assembly, the communication assembly further configured to transmit the signal to the external device.	JP2003222611A CLAIM 1 【特許請求の範囲】 【請求項１】 基板と、該基板の表面に形成された試料 の通る流路と、前記流路に設けられた試料導入部および 試料分離部とを備える分離装置であって、 前記試料分離部の表面は、親水性領域と疎水性領域とを 有することを特徴とする分離装置。 【請求項２】 基板と、該基板の表面に形成された試料 の通る流路と、前記流路に設けられた試料導入部および 試料排出部と、試料導入部から試料排出部に至るまでの 間の流路中に設けられた試料分離部とを備える分離装置 であって、前記試料分離部の表面は、離間して配置され た複数の第一の領域と、該第一の領域を除く試料分離部 表面を占める第二の領域と、を有し、第一の領域および 第二の領域のうち、一方が疎水性領域であり、他方が親 水性領域であることを特徴とする分離装置。 【請求項３】 請求項２に記載の分離装置において、前 記第一の領域が２次元的に略等間隔で配置されているこ とを特徴とする分離装置。 【請求項４】 請求項２または３に記載の分離装置にお いて、前記試料分離部を複数備えたことを特徴とする分 離装置。 【請求項５】 請求項４に記載の分離装置において、隣 接する試料分離部の間隔が、各試料分離部を構成する第 一の領域の間隔よりも広いことを特徴とする分離装置。 【請求項６】 請求項４または５に記載の分離装置にお いて、各試料分離部における第一の領域の間隔が互いに 異なることを特徴とする分離装置。 【請求項７】 請求項１乃至６ (fluid communication) いずれかに記載の分離装 置において、外力付与手段をさらに備え、外力により前 記試料を試料導入部から前記試料分離部の方向へ移動せ しめるようにしたことを特徴とする分離装置。 【請求項８】 請求項１乃至７いずれかに記載の分離装 置において、前記試料分離部の下流側に検出部を備えた ことを特徴とする分離装置。 【請求項９】 請求項１乃至８いずれかに記載の分離装 置において、前記疎水性領域は、疎水基を有する化合物 を含む膜により構成されたことを特徴とする分離装置。 【請求項１０】 請求項９に記載の分離装置において、 前記疎水基を有する化合物は、疎水基を有するシランカ ップリング剤であることを特徴とする分離装置。 【請求項１１】 請求項９または１０に記載の分離装置 において、前記疎水基はチオール基であることを特徴と する分離装置。 【請求項１２】 請求項１乃至８いずれかに記載の分離 装置において、前記疎水性領域は、シリコーン化合物を 含むことを特徴とする分離装置。 【請求項１３】 請求項１乃至１２いずれかに記載の分 離装置において、前記親水性領域は、親水基を有する化 合物を含む膜により構成されたことを特徴とする分離装 置。 【請求項１４】 請求項１３に記載の分離装置におい て、前記親水基を有する化合物は、親水基を有するシラ ンカップリング剤であることを特徴とする分離装置。 【請求項１５】 請求項１４に記載の分離装置におい て、前記シランカップリング剤はアミノ基を有する化合 物であることを特徴とする分離装置。 【請求項１６】 請求項１乃至１５いずれかに記載の分 離装置を用い、前記試料導入部から試料を導入し、試料 中の所定成分を分離することを特徴とする試料分離方 法。 【請求項１７】 基板と、該基板の表面に形成された試 料の通る流路と、前記流路中に設けられた試料分離部と を備える分離装置の製造方法であって、 親水性表面を有する前記流路を形成する工程と、 前記流路の表面の少なくとも一部に、開口部 (metering element) を有するマ スクを設けた後、該開口部から前記流路表面に疎水基を 有する化合物を堆積し、次いで該マスクを除去すること により、疎水性領域が配置された前記試料分離部を形成 する工程と、を含むことを特徴とする分離装置の製造方 法。 【請求項１８】 請求項１７に記載の分離装置の製造方 法において、前記化合物は、疎水基を有するシランカッ プリング剤であることを特徴とする分離装置の製造方 法。 【請求項１９】 請求項１８に記載の分離装置の製造方 法において、前記疎水基はチオール基であることを特徴 とする分離装置の製造方法。 【請求項２０】 基板と、該基板の表面に形成された試 料の通る流路と、前記流路中に設けられた試料分離部と を備える分離装置の製造方法であって、 疎水性表面を有する基板に前記流路を形成する工程と、 前記流路の表面の少なくとも一部に開口部を有するマス クを設けた後、該開口部から前記流路表面に親水基を有 する化合物を堆積し、次いで該マスクを除去することに より、親水性領域が配置された前記試料分離部を形成す る工程と、を含むことを特徴とする分離装置の製造方 法。 【請求項２１】 請求項２０に記載の分離装置の製造方 法において、前記化合物は、親水基を有するシランカッ プリング剤であることを特徴とする分離装置の製造方 法。 【請求項２２】 請求項２１に記載の分離装置の製造方 法において、前記親水基はアミノ基であることを特徴と する分離装置の製造方法。 【請求項２３】 基板と、該基板の表面に形成された試 料の通る流路と、前記流路中に設けられた試料分離部と を備える分離装置の製造方法であって、 親水性表面を有する前記流路を形成する工程と、 前記流路の表面に対して液状シリコーン化合物を付着 し、疎水性領域が配置された前記試料分離部を形成する 工程と、を含むことを特徴とする分離装置の製造方法。 【請求項２４】 請求項２３に記載の分離装置の製造方 法において、 前記試料分離部を形成する前記工程は、前記液状シリコ ーン化合物を含有するシリコーン樹脂の表面を前記前記 流路表面に接触させる工程を含むことを特徴とする分離 装置の製造方法。
US10533994B2 CLAIM 2. The system of claim 1 , wherein the metering element (開口部) comprises a pin.	JP2003222611A CLAIM 1 【特許請求の範囲】 【請求項１】 基板と、該基板の表面に形成された試料 の通る流路と、前記流路に設けられた試料導入部および 試料分離部とを備える分離装置であって、 前記試料分離部の表面は、親水性領域と疎水性領域とを 有することを特徴とする分離装置。 【請求項２】 基板と、該基板の表面に形成された試料 の通る流路と、前記流路に設けられた試料導入部および 試料排出部と、試料導入部から試料排出部に至るまでの 間の流路中に設けられた試料分離部とを備える分離装置 であって、前記試料分離部の表面は、離間して配置され た複数の第一の領域と、該第一の領域を除く試料分離部 表面を占める第二の領域と、を有し、第一の領域および 第二の領域のうち、一方が疎水性領域であり、他方が親 水性領域であることを特徴とする分離装置。 【請求項３】 請求項２に記載の分離装置において、前 記第一の領域が２次元的に略等間隔で配置されているこ とを特徴とする分離装置。 【請求項４】 請求項２または３に記載の分離装置にお いて、前記試料分離部を複数備えたことを特徴とする分 離装置。 【請求項５】 請求項４に記載の分離装置において、隣 接する試料分離部の間隔が、各試料分離部を構成する第 一の領域の間隔よりも広いことを特徴とする分離装置。 【請求項６】 請求項４または５に記載の分離装置にお いて、各試料分離部における第一の領域の間隔が互いに 異なることを特徴とする分離装置。 【請求項７】 請求項１乃至６いずれかに記載の分離装 置において、外力付与手段をさらに備え、外力により前 記試料を試料導入部から前記試料分離部の方向へ移動せ しめるようにしたことを特徴とする分離装置。 【請求項８】 請求項１乃至７いずれかに記載の分離装 置において、前記試料分離部の下流側に検出部を備えた ことを特徴とする分離装置。 【請求項９】 請求項１乃至８いずれかに記載の分離装 置において、前記疎水性領域は、疎水基を有する化合物 を含む膜により構成されたことを特徴とする分離装置。 【請求項１０】 請求項９に記載の分離装置において、 前記疎水基を有する化合物は、疎水基を有するシランカ ップリング剤であることを特徴とする分離装置。 【請求項１１】 請求項９または１０に記載の分離装置 において、前記疎水基はチオール基であることを特徴と する分離装置。 【請求項１２】 請求項１乃至８いずれかに記載の分離 装置において、前記疎水性領域は、シリコーン化合物を 含むことを特徴とする分離装置。 【請求項１３】 請求項１乃至１２いずれかに記載の分 離装置において、前記親水性領域は、親水基を有する化 合物を含む膜により構成されたことを特徴とする分離装 置。 【請求項１４】 請求項１３に記載の分離装置におい て、前記親水基を有する化合物は、親水基を有するシラ ンカップリング剤であることを特徴とする分離装置。 【請求項１５】 請求項１４に記載の分離装置におい て、前記シランカップリング剤はアミノ基を有する化合 物であることを特徴とする分離装置。 【請求項１６】 請求項１乃至１５いずれかに記載の分 離装置を用い、前記試料導入部から試料を導入し、試料 中の所定成分を分離することを特徴とする試料分離方 法。 【請求項１７】 基板と、該基板の表面に形成された試 料の通る流路と、前記流路中に設けられた試料分離部と を備える分離装置の製造方法であって、 親水性表面を有する前記流路を形成する工程と、 前記流路の表面の少なくとも一部に、開口部 (metering element) を有するマ スクを設けた後、該開口部から前記流路表面に疎水基を 有する化合物を堆積し、次いで該マスクを除去すること により、疎水性領域が配置された前記試料分離部を形成 する工程と、を含むことを特徴とする分離装置の製造方 法。 【請求項１８】 請求項１７に記載の分離装置の製造方 法において、前記化合物は、疎水基を有するシランカッ プリング剤であることを特徴とする分離装置の製造方 法。 【請求項１９】 請求項１８に記載の分離装置の製造方 法において、前記疎水基はチオール基であることを特徴 とする分離装置の製造方法。 【請求項２０】 基板と、該基板の表面に形成された試 料の通る流路と、前記流路中に設けられた試料分離部と を備える分離装置の製造方法であって、 疎水性表面を有する基板に前記流路を形成する工程と、 前記流路の表面の少なくとも一部に開口部を有するマス クを設けた後、該開口部から前記流路表面に親水基を有 する化合物を堆積し、次いで該マスクを除去することに より、親水性領域が配置された前記試料分離部を形成す る工程と、を含むことを特徴とする分離装置の製造方 法。 【請求項２１】 請求項２０に記載の分離装置の製造方 法において、前記化合物は、親水基を有するシランカッ プリング剤であることを特徴とする分離装置の製造方 法。 【請求項２２】 請求項２１に記載の分離装置の製造方 法において、前記親水基はアミノ基であることを特徴と する分離装置の製造方法。 【請求項２３】 基板と、該基板の表面に形成された試 料の通る流路と、前記流路中に設けられた試料分離部と を備える分離装置の製造方法であって、 親水性表面を有する前記流路を形成する工程と、 前記流路の表面に対して液状シリコーン化合物を付着 し、疎水性領域が配置された前記試料分離部を形成する 工程と、を含むことを特徴とする分離装置の製造方法。 【請求項２４】 請求項２３に記載の分離装置の製造方 法において、 前記試料分離部を形成する前記工程は、前記液状シリコ ーン化合物を含有するシリコーン樹脂の表面を前記前記 流路表面に接触させる工程を含むことを特徴とする分離 装置の製造方法。
US10533994B2 CLAIM 10. The system of claim 1 , wherein the reaction site of the assay assembly is in fluidic communication with the sample collection unit, the reaction site containing a reactant that reacts with the analyte to yield a signal indicative of the presence of the analyte; and the assay assembly further comprises: a reagent chamber in fluidic communication with the reaction site, wherein the reagent chamber is configured to store an assay reagent; a fluidic channel connecting the reagent chamber with the reaction site; and an actuatable valve assembly configured to control the flow of reagent through the fluidic channel, wherein the valve assembly comprises a sealing element (の流路) and actuator element, wherein the channel comprises first and second locations, wherein the sealing element positioned in the first location obstructs the flow of fluid through the channel and the sealing element positioned in the second location allows the flow of fluid through the channel, and wherein the actuator element is adapted to move the sealing element from the first location to the second location.	JP2003222611A CLAIM 1 【特許請求の範囲】 【請求項１】 基板と、該基板の表面に形成された試料 の通る流路と、前記流路に設けられた試料導入部および 試料分離部とを備える分離装置であって、 前記試料分離部の表面は、親水性領域と疎水性領域とを 有することを特徴とする分離装置。 【請求項２】 基板と、該基板の表面に形成された試料 の通る流路と、前記流路に設けられた試料導入部および 試料排出部と、試料導入部から試料排出部に至るまでの 間の流路 (sealing element) 中に設けられた試料分離部とを備える分離装置 であって、前記試料分離部の表面は、離間して配置され た複数の第一の領域と、該第一の領域を除く試料分離部 表面を占める第二の領域と、を有し、第一の領域および 第二の領域のうち、一方が疎水性領域であり、他方が親 水性領域であることを特徴とする分離装置。 【請求項３】 請求項２に記載の分離装置において、前 記第一の領域が２次元的に略等間隔で配置されているこ とを特徴とする分離装置。 【請求項４】 請求項２または３に記載の分離装置にお いて、前記試料分離部を複数備えたことを特徴とする分 離装置。 【請求項５】 請求項４に記載の分離装置において、隣 接する試料分離部の間隔が、各試料分離部を構成する第 一の領域の間隔よりも広いことを特徴とする分離装置。 【請求項６】 請求項４または５に記載の分離装置にお いて、各試料分離部における第一の領域の間隔が互いに 異なることを特徴とする分離装置。 【請求項７】 請求項１乃至６いずれかに記載の分離装 置において、外力付与手段をさらに備え、外力により前 記試料を試料導入部から前記試料分離部の方向へ移動せ しめるようにしたことを特徴とする分離装置。 【請求項８】 請求項１乃至７いずれかに記載の分離装 置において、前記試料分離部の下流側に検出部を備えた ことを特徴とする分離装置。 【請求項９】 請求項１乃至８いずれかに記載の分離装 置において、前記疎水性領域は、疎水基を有する化合物 を含む膜により構成されたことを特徴とする分離装置。 【請求項１０】 請求項９に記載の分離装置において、 前記疎水基を有する化合物は、疎水基を有するシランカ ップリング剤であることを特徴とする分離装置。 【請求項１１】 請求項９または１０に記載の分離装置 において、前記疎水基はチオール基であることを特徴と する分離装置。 【請求項１２】 請求項１乃至８いずれかに記載の分離 装置において、前記疎水性領域は、シリコーン化合物を 含むことを特徴とする分離装置。 【請求項１３】 請求項１乃至１２いずれかに記載の分 離装置において、前記親水性領域は、親水基を有する化 合物を含む膜により構成されたことを特徴とする分離装 置。 【請求項１４】 請求項１３に記載の分離装置におい て、前記親水基を有する化合物は、親水基を有するシラ ンカップリング剤であることを特徴とする分離装置。 【請求項１５】 請求項１４に記載の分離装置におい て、前記シランカップリング剤はアミノ基を有する化合 物であることを特徴とする分離装置。 【請求項１６】 請求項１乃至１５いずれかに記載の分 離装置を用い、前記試料導入部から試料を導入し、試料 中の所定成分を分離することを特徴とする試料分離方 法。 【請求項１７】 基板と、該基板の表面に形成された試 料の通る流路と、前記流路中に設けられた試料分離部と を備える分離装置の製造方法であって、 親水性表面を有する前記流路を形成する工程と、 前記流路の表面の少なくとも一部に、開口部を有するマ スクを設けた後、該開口部から前記流路表面に疎水基を 有する化合物を堆積し、次いで該マスクを除去すること により、疎水性領域が配置された前記試料分離部を形成 する工程と、を含むことを特徴とする分離装置の製造方 法。 【請求項１８】 請求項１７に記載の分離装置の製造方 法において、前記化合物は、疎水基を有するシランカッ プリング剤であることを特徴とする分離装置の製造方 法。 【請求項１９】 請求項１８に記載の分離装置の製造方 法において、前記疎水基はチオール基であることを特徴 とする分離装置の製造方法。 【請求項２０】 基板と、該基板の表面に形成された試 料の通る流路と、前記流路中に設けられた試料分離部と を備える分離装置の製造方法であって、 疎水性表面を有する基板に前記流路を形成する工程と、 前記流路の表面の少なくとも一部に開口部を有するマス クを設けた後、該開口部から前記流路表面に親水基を有 する化合物を堆積し、次いで該マスクを除去することに より、親水性領域が配置された前記試料分離部を形成す る工程と、を含むことを特徴とする分離装置の製造方 法。 【請求項２１】 請求項２０に記載の分離装置の製造方 法において、前記化合物は、親水基を有するシランカッ プリング剤であることを特徴とする分離装置の製造方 法。 【請求項２２】 請求項２１に記載の分離装置の製造方 法において、前記親水基はアミノ基であることを特徴と する分離装置の製造方法。 【請求項２３】 基板と、該基板の表面に形成された試 料の通る流路と、前記流路中に設けられた試料分離部と を備える分離装置の製造方法であって、 親水性表面を有する前記流路を形成する工程と、 前記流路の表面に対して液状シリコーン化合物を付着 し、疎水性領域が配置された前記試料分離部を形成する 工程と、を含むことを特徴とする分離装置の製造方法。 【請求項２４】 請求項２３に記載の分離装置の製造方 法において、 前記試料分離部を形成する前記工程は、前記液状シリコ ーン化合物を含有するシリコーン樹脂の表面を前記前記 流路表面に接触させる工程を含むことを特徴とする分離 装置の製造方法。
US10533994B2 CLAIM 14. The system of claim 10 , wherein the actuator element comprises a sealing member such that when the actuator element moves the sealing element (の流路) the sealing member forms a substantially air tight seal such that the fluid can only flow through the channel.	JP2003222611A CLAIM 1 【特許請求の範囲】 【請求項１】 基板と、該基板の表面に形成された試料 の通る流路と、前記流路に設けられた試料導入部および 試料分離部とを備える分離装置であって、 前記試料分離部の表面は、親水性領域と疎水性領域とを 有することを特徴とする分離装置。 【請求項２】 基板と、該基板の表面に形成された試料 の通る流路と、前記流路に設けられた試料導入部および 試料排出部と、試料導入部から試料排出部に至るまでの 間の流路 (sealing element) 中に設けられた試料分離部とを備える分離装置 であって、前記試料分離部の表面は、離間して配置され た複数の第一の領域と、該第一の領域を除く試料分離部 表面を占める第二の領域と、を有し、第一の領域および 第二の領域のうち、一方が疎水性領域であり、他方が親 水性領域であることを特徴とする分離装置。 【請求項３】 請求項２に記載の分離装置において、前 記第一の領域が２次元的に略等間隔で配置されているこ とを特徴とする分離装置。 【請求項４】 請求項２または３に記載の分離装置にお いて、前記試料分離部を複数備えたことを特徴とする分 離装置。 【請求項５】 請求項４に記載の分離装置において、隣 接する試料分離部の間隔が、各試料分離部を構成する第 一の領域の間隔よりも広いことを特徴とする分離装置。 【請求項６】 請求項４または５に記載の分離装置にお いて、各試料分離部における第一の領域の間隔が互いに 異なることを特徴とする分離装置。 【請求項７】 請求項１乃至６いずれかに記載の分離装 置において、外力付与手段をさらに備え、外力により前 記試料を試料導入部から前記試料分離部の方向へ移動せ しめるようにしたことを特徴とする分離装置。 【請求項８】 請求項１乃至７いずれかに記載の分離装 置において、前記試料分離部の下流側に検出部を備えた ことを特徴とする分離装置。 【請求項９】 請求項１乃至８いずれかに記載の分離装 置において、前記疎水性領域は、疎水基を有する化合物 を含む膜により構成されたことを特徴とする分離装置。 【請求項１０】 請求項９に記載の分離装置において、 前記疎水基を有する化合物は、疎水基を有するシランカ ップリング剤であることを特徴とする分離装置。 【請求項１１】 請求項９または１０に記載の分離装置 において、前記疎水基はチオール基であることを特徴と する分離装置。 【請求項１２】 請求項１乃至８いずれかに記載の分離 装置において、前記疎水性領域は、シリコーン化合物を 含むことを特徴とする分離装置。 【請求項１３】 請求項１乃至１２いずれかに記載の分 離装置において、前記親水性領域は、親水基を有する化 合物を含む膜により構成されたことを特徴とする分離装 置。 【請求項１４】 請求項１３に記載の分離装置におい て、前記親水基を有する化合物は、親水基を有するシラ ンカップリング剤であることを特徴とする分離装置。 【請求項１５】 請求項１４に記載の分離装置におい て、前記シランカップリング剤はアミノ基を有する化合 物であることを特徴とする分離装置。 【請求項１６】 請求項１乃至１５いずれかに記載の分 離装置を用い、前記試料導入部から試料を導入し、試料 中の所定成分を分離することを特徴とする試料分離方 法。 【請求項１７】 基板と、該基板の表面に形成された試 料の通る流路と、前記流路中に設けられた試料分離部と を備える分離装置の製造方法であって、 親水性表面を有する前記流路を形成する工程と、 前記流路の表面の少なくとも一部に、開口部を有するマ スクを設けた後、該開口部から前記流路表面に疎水基を 有する化合物を堆積し、次いで該マスクを除去すること により、疎水性領域が配置された前記試料分離部を形成 する工程と、を含むことを特徴とする分離装置の製造方 法。 【請求項１８】 請求項１７に記載の分離装置の製造方 法において、前記化合物は、疎水基を有するシランカッ プリング剤であることを特徴とする分離装置の製造方 法。 【請求項１９】 請求項１８に記載の分離装置の製造方 法において、前記疎水基はチオール基であることを特徴 とする分離装置の製造方法。 【請求項２０】 基板と、該基板の表面に形成された試 料の通る流路と、前記流路中に設けられた試料分離部と を備える分離装置の製造方法であって、 疎水性表面を有する基板に前記流路を形成する工程と、 前記流路の表面の少なくとも一部に開口部を有するマス クを設けた後、該開口部から前記流路表面に親水基を有 する化合物を堆積し、次いで該マスクを除去することに より、親水性領域が配置された前記試料分離部を形成す る工程と、を含むことを特徴とする分離装置の製造方 法。 【請求項２１】 請求項２０に記載の分離装置の製造方 法において、前記化合物は、親水基を有するシランカッ プリング剤であることを特徴とする分離装置の製造方 法。 【請求項２２】 請求項２１に記載の分離装置の製造方 法において、前記親水基はアミノ基であることを特徴と する分離装置の製造方法。 【請求項２３】 基板と、該基板の表面に形成された試 料の通る流路と、前記流路中に設けられた試料分離部と を備える分離装置の製造方法であって、 親水性表面を有する前記流路を形成する工程と、 前記流路の表面に対して液状シリコーン化合物を付着 し、疎水性領域が配置された前記試料分離部を形成する 工程と、を含むことを特徴とする分離装置の製造方法。 【請求項２４】 請求項２３に記載の分離装置の製造方 法において、 前記試料分離部を形成する前記工程は、前記液状シリコ ーン化合物を含有するシリコーン樹脂の表面を前記前記 流路表面に接触させる工程を含むことを特徴とする分離 装置の製造方法。

US10533994B2 Filed: 2006-03-24     Issued: 2020-01-14 Systems and methods of sample processing and fluid control in a fluidic system (Original Assignee) Theranos IP Co LLC     (Current Assignee) Theranos IP Co LLC Elizabeth A. Holmes, Shaunak Roy, Ian Gibbons, Shize Daniel Qi, Edmond Ku, Chris Todd, Melissa Takahashi, Bruce Johnson, Jeff Fenton, Keith Moravick, Uwe Springborn, Anthony Delacruz	CN1415964A Filed: 2002-12-18     Issued: 2003-05-07 糖尿病自身免疫抗体检测蛋白芯片、其制备及检测方法 (Original Assignee) 陕西超英生物医学研究开发有限公司      刘镭, 罗毅, 王伟华
US10533994B2 CLAIM 5. The system of claim 4 , wherein the sample collection unit further comprises a mixing chamber (上表面) in fluidic communication with the metering channel, the mixing chamber being configured to mix the predetermined portion of the sample with the diluent to yield a diluted sample.	CN1415964A CLAIM 1.一种糖尿病自身免疫抗体检测蛋白芯片，包括外壳(1)和检测微阵列(3)，其特征在于：所述外壳(1)是上表面 (mixing chamber) 设置有多个反应池(2)的玻璃薄片，反应池(2)内均设置有一个检测微阵列(3)，每个检测微阵列(3)分别由三个不同种类的、同一规格大小的蛋白微型同相检测片组成，所述蛋白微型固相检测片分别是GAD蛋白微型固相检测片(4)、PTP蛋白微型固相检测片(5)和Insulin蛋白微型固相检测片(6)。
US10533994B2 CLAIM 10. The system of claim 1 , wherein the reaction site of the assay assembly is in fluidic communication with the sample collection unit, the reaction site containing a reactant that reacts with the analyte to yield a signal indicative of the presence of the analyte; and the assay assembly further comprises: a reagent chamber in fluidic communication with the reaction site, wherein the reagent chamber is configured to store an assay reagent; a fluidic channel connecting the reagent chamber with the reaction site; and an actuatable valve assembly configured to control the flow of reagent through the fluidic channel, wherein the valve assembly comprises a sealing element (密封包装) and actuator element, wherein the channel comprises first and second locations, wherein the sealing element positioned in the first location obstructs the flow of fluid through the channel and the sealing element positioned in the second location allows the flow of fluid through the channel, and wherein the actuator element is adapted to move the sealing element from the first location to the second location.	CN1415964A CLAIM 8.如权利要求6或7所述的糖尿病自身免疫抗体检测蛋白芯片的制备方法，其特征在于：还包括包装步骤，该步骤是将芯片表面用锡箔纸密封包装 (sealing element, sealing member) ，储存于-20℃条件下，运输时置于不高于4℃的恒温容器内。
US10533994B2 CLAIM 14. The system of claim 10 , wherein the actuator element comprises a sealing member (密封包装) such that when the actuator element moves the sealing element (密封包装) the sealing member forms a substantially air tight seal such that the fluid can only flow through the channel.	CN1415964A CLAIM 8.如权利要求6或7所述的糖尿病自身免疫抗体检测蛋白芯片的制备方法，其特征在于：还包括包装步骤，该步骤是将芯片表面用锡箔纸密封包装 (sealing element, sealing member) ，储存于-20℃条件下，运输时置于不高于4℃的恒温容器内。
US10533994B2 CLAIM 15. The system of claim 14 wherein the actuator element is substantially pin shaped and the sealing member (密封包装) is an O-ring adapted to be placed around the actuator element.	CN1415964A CLAIM 8.如权利要求6或7所述的糖尿病自身免疫抗体检测蛋白芯片的制备方法，其特征在于：还包括包装步骤，该步骤是将芯片表面用锡箔纸密封包装 (sealing element, sealing member) ，储存于-20℃条件下，运输时置于不高于4℃的恒温容器内。

US10533994B2 Filed: 2006-03-24     Issued: 2020-01-14 Systems and methods of sample processing and fluid control in a fluidic system (Original Assignee) Theranos IP Co LLC     (Current Assignee) Theranos IP Co LLC Elizabeth A. Holmes, Shaunak Roy, Ian Gibbons, Shize Daniel Qi, Edmond Ku, Chris Todd, Melissa Takahashi, Bruce Johnson, Jeff Fenton, Keith Moravick, Uwe Springborn, Anthony Delacruz

JP2003057244A Filed: 2001-08-10     Issued: 2003-02-26 記録媒体およびこの記録媒体を用いた血糖測定システム (Original Assignee) Nipro Corp; ニプロ株式会社      Takehito Ito, Hideyuki Tomita, 武仁 伊藤, 英幸 富田

US10533994B2 CLAIM 1. A system for detecting the presence or absence of an analyte in a bodily fluid sample obtained from a subject, comprising: a cartridge, comprising: a sample collection unit, comprising: a sample collection well configured to receive a portion of the sample; a metering channel in fluid communication (デジタル) with the sample collection well and configured such that the sample flows from the sample collection well into the metering channel; and a metering element comprising a mechanically movable portion configured to be movable from an open position that permits fluid communication between the sample collection well and the metering channel to a closed position that does not provide fluid communication between the sample collection well, thereby isolating a specific volume of the sample in the metering channel; a lysing assembly configured to lyse cells present in the sample; and an assay assembly comprising a reaction site containing a reactant able to react with the analyte to yield a detectable signal indicative of the presence or absence of the analyte; and a reader assembly comprising: a detection assembly configured to detect the signal; and a communication assembly configured to receive an assay protocol in response to receiving an identity of the cartridge from an external device, the external device being separate from the reader assembly, the communication assembly further configured to transmit the signal to the external device.

JP2003057244A CLAIM 1 【特許請求の範囲】 【請求項１】 電源の供給が可能な携帯端末装置に装着 されて動作する記録媒体であって、 前記携帯端末装置とデータをやり取りする通信制御部 と、 採取された血液中の血糖値に応じた電流を発生するセン サー回路部と、 前記発生した電流をデジタル (fluid communication) 変換して出力する信号処理 部と、 前記信号処理部から出力されたデータに基づいて変換さ れた血糖値データを記憶する電気的に消去および書換え が可能な不揮発性の記憶部と、 前記信号処理部から出力されたデータを前記血糖値デー タに変換して前記記憶部に書込み、前記記憶部から前記 血糖値データを読出して前記通信制御部を介して前記携 帯端末装置へ送信する制御部と、 前記携帯端末装置から電源を受電し、前記センサー回路 部と、前記信号処理部と、前記記憶部と、前記通信制御 部と、前記制御部とに電源を供給する電源制御部とを備 える記録媒体。 【請求項２】 前記携帯端末装置は、顧客の血糖値を管 理するサーバへ前記測定された血糖値データを通信網を 介して送信する、請求項１に記載の記録媒体。 【請求項３】 前記携帯端末装置は、前記測定された血 糖値データを表示する、請求項１または請求項２に記載 の記録媒体。 【請求項４】 前記携帯端末装置は、携帯電話機、携帯 情報端末装置および携帯型パソコンのいずれかである、 請求項１から３のいずれか１項に記載の記録媒体。 【請求項５】 携帯端末装置と、 前記携帯端末装置に装着されて動作する記録媒体とを備 える血糖測定システムであって、 前記携帯端末装置は、 前記記録媒体とデータをやり取りする第１の通信制御部 と、 前記記録媒体に電源を供給する電源部と、 第１の制御部とを含み、 前記記録媒体は、 前記携帯端末装置とデータをやり取りする第２の通信制 御部と、 採取された血液中の血糖値に応じた電流を発生するセン サー回路部と、 前記発生した電流をデジタル変換して出力する信号処理 部と、 前記信号処理部から出力されたデータに基づいて変換さ れた血糖値データを記憶する電気的に消去および書換え が可能な不揮発性の記憶部と、 前記信号処理部から出力されたデータを前記血糖値デー タに変換して前記記憶部に書込み、前記記憶部から前記 血糖値データを読出して前記第２の通信制御部を介して 前記携帯端末装置へ送信する第２の制御部と、 前記携帯端末装置から電源を受電し、前記センサー回路 部と、前記信号処理部と、前記記憶部と、前記第２の通 信制御部と、前記第２の制御部とに電源を供給する電源 制御部とを含み、 前記第１の制御部は、前記記録媒体から血糖値データを 受信するに際して前記第１の通信制御部を制御する、血 糖測定システム。 【請求項６】 前記携帯端末装置は、顧客の血糖値を管 理するサーバと通信網を介してデータをやり取りする第 ３の通信制御部をさらに含み、 前記第１の制御部は、前記サーバへ前記血糖値データを 送信するに際して前記記録媒体から受信した血糖値デー タを前記第３の通信制御部にさらに与える、請求項５に 記載の血糖測定システム。 【請求項７】 前記携帯端末装置は、前記血糖値データ を表示する表示部をさらに含み、 前記第１の制御部は、前記表示部に前記血糖値データを 表示するに際して前記記録媒体から受信した血糖値デー タを前記表示部にさらに与える、請求項５または請求項 ６に記載の血糖測定システム。 【請求項８】 前記携帯端末装置は、携帯電話機、携帯 情報端末装置および携帯型パソコンのいずれかである、 請求項５から７のいずれか１項に記載の血糖測定システ ム。

US10533994B2 Filed: 2006-03-24     Issued: 2020-01-14 Systems and methods of sample processing and fluid control in a fluidic system (Original Assignee) Theranos IP Co LLC     (Current Assignee) Theranos IP Co LLC Elizabeth A. Holmes, Shaunak Roy, Ian Gibbons, Shize Daniel Qi, Edmond Ku, Chris Todd, Melissa Takahashi, Bruce Johnson, Jeff Fenton, Keith Moravick, Uwe Springborn, Anthony Delacruz	JP2002371955A Filed: 2001-06-15     Issued: 2002-12-26 往復駆動装置及び該装置を使用した送液ポンプ (Original Assignee) Sanuki Kogyo Kk; サヌキ工業株式会社      Sannosuke Sanuki, 三之助 讃岐
US10533994B2 CLAIM 1. A system for detecting the presence or absence of an analyte in a bodily fluid sample obtained from a subject, comprising: a cartridge, comprising: a sample collection unit, comprising: a sample collection well configured to receive a portion of the sample; a metering channel in fluid communication with the sample collection well and configured such that the sample flows from the sample collection well into the metering channel; and a metering element comprising a mechanically movable portion configured to be movable from an open position (前記プランジャ) that permits fluid communication between the sample collection well and the metering channel to a closed position that does not provide fluid communication between the sample collection well, thereby isolating a specific volume of the sample in the metering channel; a lysing assembly configured to lyse cells present in the sample; and an assay assembly comprising a reaction site containing a reactant able to react with the analyte to yield a detectable signal indicative of the presence or absence of the analyte; and a reader assembly comprising: a detection assembly configured to detect the signal; and a communication assembly configured to receive an assay protocol in response to receiving an identity of the cartridge from an external device, the external device being separate from the reader assembly, the communication assembly further configured to transmit the signal to the external device.	JP2002371955A CLAIM 7 【請求項７】ポンプ機構部は、シリンダーと該シリンダ ー内を往復移動するプランジャーとを有するプランジャ ーポンプ機構であり、前記プランジャ (open position) ーを駆動部に連動 させるようにしてなる請求項４，５又は６に記載の送液 ポンプ。
US10533994B2 CLAIM 3. The system of claim 2 , wherein the pin is configured to be movable from an open position (前記プランジャ) to a closed position, wherein the pin in the closed position blocks the metering channel.	JP2002371955A CLAIM 7 【請求項７】ポンプ機構部は、シリンダーと該シリンダ ー内を往復移動するプランジャーとを有するプランジャ ーポンプ機構であり、前記プランジャ (open position) ーを駆動部に連動 させるようにしてなる請求項４，５又は６に記載の送液 ポンプ。

US10533994B2 Filed: 2006-03-24     Issued: 2020-01-14 Systems and methods of sample processing and fluid control in a fluidic system (Original Assignee) Theranos IP Co LLC     (Current Assignee) Theranos IP Co LLC Elizabeth A. Holmes, Shaunak Roy, Ian Gibbons, Shize Daniel Qi, Edmond Ku, Chris Todd, Melissa Takahashi, Bruce Johnson, Jeff Fenton, Keith Moravick, Uwe Springborn, Anthony Delacruz	JP2002266762A Filed: 2001-03-07     Issued: 2002-09-18 冷凍サイクル装置 (Original Assignee) Matsushita Electric Ind Co Ltd; 松下電器産業株式会社      Shozo Funakura, Fumitoshi Nishiwaki, Noriho Okaza, Masaaki Suzuki, Yuji Yoshida, 雄二 吉田, 典穂 岡座, 正三 船倉, 文俊 西脇, 正明 鈴木
US10533994B2 CLAIM 1. A system for detecting the presence or absence of an analyte in a bodily fluid sample obtained from a subject, comprising: a cartridge, comprising: a sample collection unit, comprising: a sample collection well configured to receive a portion of the sample; a metering channel in fluid communication with the sample collection well and configured such that the sample flows from the sample collection well into the metering channel; and a metering element comprising a mechanically movable portion configured to be movable from an open position that permits fluid communication between the sample collection well and the metering channel to a closed position that does not provide fluid communication between the sample collection well, thereby isolating a specific volume of the sample in the metering channel; a lysing assembly configured to lyse cells present in the sample; and an assay assembly comprising a reaction site (非極性) containing a reactant able to react with the analyte to yield a detectable signal indicative of the presence or absence of the analyte; and a reader assembly comprising: a detection assembly configured to detect the signal; and a communication assembly configured to receive an assay protocol in response to receiving an identity of the cartridge from an external device, the external device being separate from the reader assembly, the communication assembly further configured to transmit the signal to the external device.	JP2002266762A CLAIM 1 【請求項１】 二酸化炭素（ＣＯ２）冷媒が封入され、 密閉容器内に電動要素と圧縮要素を備えた密閉型電動圧 縮機と、非極性 (reaction site) 油あるいは有極性油を主たる組成とする 冷凍機油と、前記密閉型電動圧縮機内の冷凍機油の加熱 手段を設けたことを特徴とする冷凍サイクル装置。
US10533994B2 CLAIM 4. The system of claim 2 , wherein the sample collection unit further comprises: a dilution chamber in fluidic communication with the metering channel, wherein the dilution chamber is configured to store a diluent and comprises a port engaging pressure means (４０００) transferring the diluent from the dilution chamber into the metering channel.	JP2002266762A CLAIM 5 【請求項５】 前記電動要素において、絶縁フィルムに 数平均分子量２００００〜４０００ (pressure means) ０を有するポリエチ レンテレフタレートを採用したことを特徴とする請求項 １から４のいずれかに記載の冷凍サイクル装置。
US10533994B2 CLAIM 10. The system of claim 1 , wherein the reaction site (非極性) of the assay assembly is in fluidic communication with the sample collection unit, the reaction site containing a reactant that reacts with the analyte to yield a signal indicative of the presence of the analyte; and the assay assembly further comprises: a reagent chamber in fluidic communication with the reaction site, wherein the reagent chamber is configured to store an assay reagent; a fluidic channel connecting the reagent chamber with the reaction site; and an actuatable valve assembly configured to control the flow of reagent through the fluidic channel, wherein the valve assembly comprises a sealing element and actuator element, wherein the channel comprises first and second locations, wherein the sealing element positioned in the first location obstructs the flow of fluid through the channel and the sealing element positioned in the second location allows the flow of fluid through the channel, and wherein the actuator element is adapted to move the sealing element from the first location to the second location.	JP2002266762A CLAIM 1 【請求項１】 二酸化炭素（ＣＯ２）冷媒が封入され、 密閉容器内に電動要素と圧縮要素を備えた密閉型電動圧 縮機と、非極性 (reaction site) 油あるいは有極性油を主たる組成とする 冷凍機油と、前記密閉型電動圧縮機内の冷凍機油の加熱 手段を設けたことを特徴とする冷凍サイクル装置。

US10533994B2 Filed: 2006-03-24     Issued: 2020-01-14 Systems and methods of sample processing and fluid control in a fluidic system (Original Assignee) Theranos IP Co LLC     (Current Assignee) Theranos IP Co LLC Elizabeth A. Holmes, Shaunak Roy, Ian Gibbons, Shize Daniel Qi, Edmond Ku, Chris Todd, Melissa Takahashi, Bruce Johnson, Jeff Fenton, Keith Moravick, Uwe Springborn, Anthony Delacruz	JP2002263185A Filed: 2001-03-12     Issued: 2002-09-17 投薬システム及び方法及び投薬装置 (Original Assignee) Sanyo Electric Co Ltd; 三洋電機株式会社      Hiroyuki Kuriyama, Hajime Miyaki, Tomitaro Nishimura, Akira Uchida, 昭 内田, 一 宮木, 博之 栗山, 富太郎 西村
US10533994B2 CLAIM 4. The system of claim 2 , wherein the sample collection unit further comprises: a dilution chamber in fluidic communication with the metering channel, wherein the dilution chamber is configured to store a diluent and comprises a port engaging pressure means (投薬機構) transferring the diluent from the dilution chamber into the metering channel.	JP2002263185A CLAIM 1 【請求項１】 投薬管理装置と、無線端末を備えた投薬 装置とが、ネットワークを介してデータを送受信可能で あり、 前記投薬管理装置は、前記投薬装置の投薬スケジュール を持つ投薬計画保持手段と、前記投薬スケジュールが指 示する投薬時間になるとネットワークを介して前記投薬 装置へ投薬を指示する投薬指示手段と、を有し、 前記投薬装置は、患者の被投薬部位に対して投薬を実行 し得るように患者の身体に装着された投薬機構 (pressure means, port engaging pressure means) と、前記 投薬管理装置からの投薬指示に従って前記投薬機構を動 作させて投薬を実行させる投薬制御手段と、を有する、 ことを特徴とする投薬システム。

US10533994B2 Filed: 2006-03-24     Issued: 2020-01-14 Systems and methods of sample processing and fluid control in a fluidic system (Original Assignee) Theranos IP Co LLC     (Current Assignee) Theranos IP Co LLC Elizabeth A. Holmes, Shaunak Roy, Ian Gibbons, Shize Daniel Qi, Edmond Ku, Chris Todd, Melissa Takahashi, Bruce Johnson, Jeff Fenton, Keith Moravick, Uwe Springborn, Anthony Delacruz	EP1225442A2 Filed: 2002-01-14     Issued: 2002-07-24 Method and apparatus for using infrared readings to detect misidentification of a diagnostic test strip in a reflectance spectrometer (Original Assignee) Bayer AG; Bayer Corp     (Current Assignee) Siemens Healthcare Diagnostics Inc Gary E. Rehm
US10533994B2 CLAIM 1. A system for detecting the presence or absence of an analyte in a bodily fluid sample obtained from a subject, comprising: a cartridge, comprising: a sample collection unit, comprising: a sample collection well configured to receive a portion of the sample; a metering channel in fluid communication with the sample collection well and configured such that the sample flows from the sample collection well into the metering channel; and a metering element comprising a mechanically movable portion configured to be movable from an open position that permits fluid communication between the sample collection well and the metering channel to a closed position that does not provide fluid communication between the sample collection well, thereby isolating a specific volume of the sample in the metering channel; a lysing assembly configured to lyse cells present in the sample; and an assay assembly comprising a reaction site containing a reactant able to react with the analyte to yield a detectable signal indicative of the presence or absence of the analyte; and a reader assembly comprising: a detection assembly configured to detect the signal; and a communication assembly configured to receive an assay protocol (said test field) in response to receiving an identity of the cartridge from an external device, the external device being separate from the reader assembly, the communication assembly further configured to transmit the signal to the external device.	EP1225442A2 CLAIM 15 An automated method of reading a test strip for the analysis of one or more analyte(s) in a liquid test sample that comprises the steps of: a) providing a test strip having at least one test field on its surface that reflects light at a specific range of wavelengths and at least two distinct marker fields on the same surface of said test strip as said test field (assay protocol, assay reagent) , said marker fields reflecting light at different ranges of wavelengths from each other and from said test field in a coded sequence of ranges of wavelengths, said coded sequence correlates to information concerning identification of the test strip; b) introducing said test strip into a strip reading device equipped with reading means for both said test field and said marker fields, said reading means comprises a light source as transmitter and a light sensitive element as receiver, said receiver being capable of differentiating between said ranges of wavelengths at which said test field and said marker fields reflect, said strip reading device also being equipped with means for correlating the coded range of infrared wavelength sequence of reflected light with preprogrammed information concerning said test strip, said correlating means being in operative communication with a receiving means, said reading device having means for moving said test strip and said receiving means relative to one another so that the reflectance of said test field and said marker fields can be individually read by said reading means; c) allowing said ranges of wavelength values reflected by said test field and said marker fields to be individually read by said reading means; d) allowing said reading means to communicate said coded infrared sequence of spectral reflectance values reflected from said marker fields to said correlating means and allowing said correlating means to correlate said infrared sequence of reflected range of wavelength values with said preprogrammed information concerning said test strip; and e) allowing said reading means to communicate said reflected range of infrared wavelength values to said correlating means and allowing said correlating means to determine, for one or more of the reagents disposed on said test strip, if said reflected range of infrared wavelength values are within a predetermined range of infrared reflectances.
US10533994B2 CLAIM 18. The system of claim 1 , wherein the assay protocol (said test field) is transmitted wirelessly from the external device.	EP1225442A2 CLAIM 15 An automated method of reading a test strip for the analysis of one or more analyte(s) in a liquid test sample that comprises the steps of: a) providing a test strip having at least one test field on its surface that reflects light at a specific range of wavelengths and at least two distinct marker fields on the same surface of said test strip as said test field (assay protocol, assay reagent) , said marker fields reflecting light at different ranges of wavelengths from each other and from said test field in a coded sequence of ranges of wavelengths, said coded sequence correlates to information concerning identification of the test strip; b) introducing said test strip into a strip reading device equipped with reading means for both said test field and said marker fields, said reading means comprises a light source as transmitter and a light sensitive element as receiver, said receiver being capable of differentiating between said ranges of wavelengths at which said test field and said marker fields reflect, said strip reading device also being equipped with means for correlating the coded range of infrared wavelength sequence of reflected light with preprogrammed information concerning said test strip, said correlating means being in operative communication with a receiving means, said reading device having means for moving said test strip and said receiving means relative to one another so that the reflectance of said test field and said marker fields can be individually read by said reading means; c) allowing said ranges of wavelength values reflected by said test field and said marker fields to be individually read by said reading means; d) allowing said reading means to communicate said coded infrared sequence of spectral reflectance values reflected from said marker fields to said correlating means and allowing said correlating means to correlate said infrared sequence of reflected range of wavelength values with said preprogrammed information concerning said test strip; and e) allowing said reading means to communicate said reflected range of infrared wavelength values to said correlating means and allowing said correlating means to determine, for one or more of the reagents disposed on said test strip, if said reflected range of infrared wavelength values are within a predetermined range of infrared reflectances.

US10533994B2 Filed: 2006-03-24     Issued: 2020-01-14 Systems and methods of sample processing and fluid control in a fluidic system (Original Assignee) Theranos IP Co LLC     (Current Assignee) Theranos IP Co LLC Elizabeth A. Holmes, Shaunak Roy, Ian Gibbons, Shize Daniel Qi, Edmond Ku, Chris Todd, Melissa Takahashi, Bruce Johnson, Jeff Fenton, Keith Moravick, Uwe Springborn, Anthony Delacruz	JP2002161856A Filed: 2000-11-28     Issued: 2002-06-07 シャフトおよびシャフトの製造方法 (Original Assignee) Matsushita Electric Ind Co Ltd; 松下電器産業株式会社      Hiroyuki Fukuhara, Mitsuharu Matsuo, Fumitoshi Nishiwaki, Hideto Oka, Hidenobu Shintaku, 秀人 岡, 秀信 新宅, 光晴 松尾, 弘之 福原, 文俊 西脇
US10533994B2 CLAIM 1. A system for detecting the presence or absence of an analyte in a bodily fluid sample obtained from a subject, comprising: a cartridge, comprising: a sample collection unit, comprising: a sample collection well configured to receive a portion of the sample; a metering channel in fluid communication with the sample collection well and configured such that the sample flows from the sample collection well into the metering channel; and a metering element comprising a mechanically movable portion configured to be movable from an open position (前記密閉容器) that permits fluid communication between the sample collection well and the metering channel to a closed position that does not provide fluid communication between the sample collection well, thereby isolating a specific volume of the sample in the metering channel; a lysing assembly configured to lyse cells present in the sample; and an assay assembly comprising a reaction site (マルテン) containing a reactant able to react with the analyte to yield a detectable signal indicative of the presence or absence of the analyte; and a reader assembly comprising: a detection assembly configured to detect the signal; and a communication assembly configured to receive an assay protocol in response to receiving an identity of the cartridge from an external device, the external device being separate from the reader assembly, the communication assembly further configured to transmit the signal to the external device.	JP2002161856A CLAIM 1 【請求項１】 密閉容器と、前記密閉容器 (open position) 内に設けられ た、固定子と回転子とを有する電動機と、前記電動機か らの動力により駆動する圧縮機構部とを少なくとも備え た密閉型圧縮機に用いられる、前記電動機から前記圧縮 機溝部へ動力を伝達するためのシャフトであって、 前記シャフトの摺動面の表面層は、少なくとも窒素との 化合物層の厚み以上の部分を含まない、窒化処理された 部分から形成されていることを特徴とするシャフト。 JP2002161856A CLAIM 6 【請求項６】 Ｃｒを１１．５０％〜１８．００％含む マルテン (reaction site) サイト系ステンレス鋼で製作されたことを特徴 とする請求項４に記載のシャフト。
US10533994B2 CLAIM 3. The system of claim 2 , wherein the pin is configured to be movable from an open position (前記密閉容器) to a closed position, wherein the pin in the closed position blocks the metering channel.	JP2002161856A CLAIM 1 【請求項１】 密閉容器と、前記密閉容器 (open position) 内に設けられ た、固定子と回転子とを有する電動機と、前記電動機か らの動力により駆動する圧縮機構部とを少なくとも備え た密閉型圧縮機に用いられる、前記電動機から前記圧縮 機溝部へ動力を伝達するためのシャフトであって、 前記シャフトの摺動面の表面層は、少なくとも窒素との 化合物層の厚み以上の部分を含まない、窒化処理された 部分から形成されていることを特徴とするシャフト。
US10533994B2 CLAIM 10. The system of claim 1 , wherein the reaction site (マルテン) of the assay assembly is in fluidic communication with the sample collection unit, the reaction site containing a reactant that reacts with the analyte to yield a signal indicative of the presence of the analyte; and the assay assembly further comprises: a reagent chamber in fluidic communication with the reaction site, wherein the reagent chamber is configured to store an assay reagent; a fluidic channel connecting the reagent chamber with the reaction site; and an actuatable valve assembly configured to control the flow of reagent through the fluidic channel, wherein the valve assembly comprises a sealing element and actuator element, wherein the channel comprises first and second locations, wherein the sealing element positioned in the first location obstructs the flow of fluid through the channel and the sealing element positioned in the second location allows the flow of fluid through the channel, and wherein the actuator element is adapted to move the sealing element from the first location to the second location.	JP2002161856A CLAIM 6 【請求項６】 Ｃｒを１１．５０％〜１８．００％含む マルテン (reaction site) サイト系ステンレス鋼で製作されたことを特徴 とする請求項４に記載のシャフト。

US10533994B2 Filed: 2006-03-24     Issued: 2020-01-14 Systems and methods of sample processing and fluid control in a fluidic system (Original Assignee) Theranos IP Co LLC     (Current Assignee) Theranos IP Co LLC Elizabeth A. Holmes, Shaunak Roy, Ian Gibbons, Shize Daniel Qi, Edmond Ku, Chris Todd, Melissa Takahashi, Bruce Johnson, Jeff Fenton, Keith Moravick, Uwe Springborn, Anthony Delacruz

JP2002041654A Filed: 2001-04-17     Issued: 2002-02-08 契約ベースのバイオセンサーモニターシステムおよびバイオセンサーモニター方法 (Original Assignee) Roche Diagnostics Corp; Roche Diagnostics Gmbh; ロッシュ ダイアグノスティクス コーポレーション; ロッシュ ディアグノスティクス ゲゼルシャフト ミット ベシュレンクテル ハフツング      Cristoph Cronrath, Matthias Essenpreis, Martin T Gerber, Michael V Hansen, クロンラト クリストフ, ブイ ハンセン マイクル, エッセンプライス マチアス, テー ガーバー マルチン

US10533994B2 CLAIM 10. The system of claim 1 , wherein the reaction site of the assay assembly is in fluidic communication with the sample collection unit, the reaction site containing a reactant that reacts with the analyte to yield a signal indicative of the presence of the analyte; and the assay assembly further comprises: a reagent chamber in fluidic communication with the reaction site, wherein the reagent chamber is configured to store an assay reagent; a fluidic channel connecting the reagent chamber with the reaction site; and an actuatable valve assembly configured to control the flow of reagent through the fluidic channel, wherein the valve assembly comprises a sealing element and actuator element, wherein the channel comprises first and second locations, wherein the sealing element positioned in the first location (前記テスト) obstructs the flow of fluid through the channel and the sealing element positioned in the second location allows the flow of fluid through the channel, and wherein the actuator element is adapted to move the sealing element from the first location to the second location.

JP2002041654A CLAIM 5 【請求項５】 前記テスト (first location) 媒体が電気的に読み出し可能 な情報媒体を有することを特徴とする請求項２記載のシ ステム。

US10533994B2 Filed: 2006-03-24     Issued: 2020-01-14 Systems and methods of sample processing and fluid control in a fluidic system (Original Assignee) Theranos IP Co LLC     (Current Assignee) Theranos IP Co LLC Elizabeth A. Holmes, Shaunak Roy, Ian Gibbons, Shize Daniel Qi, Edmond Ku, Chris Todd, Melissa Takahashi, Bruce Johnson, Jeff Fenton, Keith Moravick, Uwe Springborn, Anthony Delacruz

JP2002044007A Filed: 2000-07-26     Issued: 2002-02-08 携帯電話機 (Original Assignee) Ricoh Elemex Corp; リコーエレメックス株式会社      Nobuhiro Takeda, 修宏 武田

US10533994B2 CLAIM 1. A system for detecting the presence or absence of an analyte in a bodily fluid sample obtained from a subject, comprising: a cartridge, comprising: a sample collection unit, comprising: a sample collection well configured to receive a portion of the sample; a metering channel in fluid communication with the sample collection well and configured such that the sample flows from the sample collection well into the metering channel; and a metering element comprising a mechanically movable portion configured to be movable from an open position that permits fluid communication between the sample collection well and the metering channel to a closed position that does not provide fluid communication between the sample collection well, thereby isolating a specific volume of the sample in the metering channel; a lysing assembly configured to lyse cells present in the sample; and an assay assembly comprising a reaction site containing a reactant able to react with the analyte to yield a detectable signal indicative of the presence or absence of the analyte; and a reader assembly comprising: a detection assembly (検出信号) configured to detect the signal; and a communication assembly configured to receive an assay protocol in response to receiving an identity of the cartridge from an external device, the external device being separate from the reader assembly, the communication assembly further configured to transmit the signal to the external device.

JP2002044007A CLAIM 2 【請求項２】 前記センサで呼気中の所定のガスを検出 し、その検出信号 (detection assembly) から計算して前記目的物質測定回路で 口臭度を測定する、請求項１に記載の携帯電話機。

US10533994B2 Filed: 2006-03-24     Issued: 2020-01-14 Systems and methods of sample processing and fluid control in a fluidic system (Original Assignee) Theranos IP Co LLC     (Current Assignee) Theranos IP Co LLC Elizabeth A. Holmes, Shaunak Roy, Ian Gibbons, Shize Daniel Qi, Edmond Ku, Chris Todd, Melissa Takahashi, Bruce Johnson, Jeff Fenton, Keith Moravick, Uwe Springborn, Anthony Delacruz	JP2002031055A Filed: 2000-07-14     Issued: 2002-01-31 密閉型圧縮機 (Original Assignee) Matsushita Electric Ind Co Ltd; 松下電器産業株式会社      Mototaka Ezumi, Hiroyuki Fukuhara, Hiroshi Hasegawa, Mitsuhiro Ikoma, Shigeru Muramatsu, Fumitoshi Nishiwaki, Hideto Oka, Hidenobu Shintaku, 秀人 岡, 秀信 新宅, 繁 村松, 元隆 江住, 光博 生駒, 弘之 福原, 文俊 西脇, 寛 長谷川
US10533994B2 CLAIM 1. A system for detecting the presence or absence of an analyte in a bodily fluid sample obtained from a subject, comprising: a cartridge, comprising: a sample collection unit, comprising: a sample collection well configured to receive a portion of the sample; a metering channel in fluid communication with the sample collection well and configured such that the sample flows from the sample collection well into the metering channel; and a metering element comprising a mechanically movable portion configured to be movable from an open position that permits fluid communication between the sample collection well and the metering channel to a closed position that does not provide fluid communication between the sample collection well, thereby isolating a specific volume of the sample in the metering channel; a lysing assembly configured to lyse cells present in the sample; and an assay assembly comprising a reaction site (マルテン) containing a reactant able to react with the analyte to yield a detectable signal indicative of the presence or absence of the analyte; and a reader assembly comprising: a detection assembly configured to detect the signal; and a communication assembly configured to receive an assay protocol in response to receiving an identity of the cartridge from an external device, the external device being separate from the reader assembly, the communication assembly further configured to transmit the signal to the external device.	JP2002031055A CLAIM 6 【請求項６】 Ｃｒを１１．５０％〜１８．００％含む マルテン (reaction site) サイト系ステンレス鋼で製作された請求項１〜 ４のいずれかに記載の密閉型圧縮機。
US10533994B2 CLAIM 10. The system of claim 1 , wherein the reaction site (マルテン) of the assay assembly is in fluidic communication with the sample collection unit, the reaction site containing a reactant that reacts with the analyte to yield a signal indicative of the presence of the analyte; and the assay assembly further comprises: a reagent chamber in fluidic communication with the reaction site, wherein the reagent chamber is configured to store an assay reagent; a fluidic channel connecting the reagent chamber with the reaction site; and an actuatable valve assembly configured to control the flow of reagent through the fluidic channel, wherein the valve assembly comprises a sealing element and actuator element, wherein the channel comprises first and second locations, wherein the sealing element positioned in the first location obstructs the flow of fluid through the channel and the sealing element positioned in the second location allows the flow of fluid through the channel, and wherein the actuator element is adapted to move the sealing element from the first location to the second location.	JP2002031055A CLAIM 6 【請求項６】 Ｃｒを１１．５０％〜１８．００％含む マルテン (reaction site) サイト系ステンレス鋼で製作された請求項１〜 ４のいずれかに記載の密閉型圧縮機。

US10533994B2 Filed: 2006-03-24     Issued: 2020-01-14 Systems and methods of sample processing and fluid control in a fluidic system (Original Assignee) Theranos IP Co LLC     (Current Assignee) Theranos IP Co LLC Elizabeth A. Holmes, Shaunak Roy, Ian Gibbons, Shize Daniel Qi, Edmond Ku, Chris Todd, Melissa Takahashi, Bruce Johnson, Jeff Fenton, Keith Moravick, Uwe Springborn, Anthony Delacruz

EP1174078A2 Filed: 2001-07-05     Issued: 2002-01-23 Hollow microneedle patch (Original Assignee) Bayer AG; Bayer Corp     (Current Assignee) Bayer AG ; Bayer Corp Robert C. Whitson

US10533994B2 CLAIM 1. A system for detecting the presence or absence of an analyte in a bodily fluid sample obtained from a subject, comprising: a cartridge, comprising: a sample collection unit, comprising: a sample collection well configured to receive a portion of the sample; a metering channel in fluid communication (fluid communication) with the sample collection well and configured such that the sample flows from the sample collection well into the metering channel; and a metering element comprising a mechanically movable portion configured to be movable from an open position that permits fluid communication between the sample collection well and the metering channel to a closed position that does not provide fluid communication between the sample collection well, thereby isolating a specific volume of the sample in the metering channel; a lysing assembly configured to lyse cells present in the sample; and an assay assembly comprising a reaction site containing a reactant able to react with the analyte to yield a detectable signal indicative of the presence or absence of the analyte; and a reader assembly comprising: a detection assembly configured to detect the signal; and a communication assembly configured to receive an assay protocol in response to receiving an identity of the cartridge from an external device, the external device being separate from the reader assembly, the communication assembly further configured to transmit the signal to the external device.

EP1174078A2 CLAIM 1 A test strip for use in the determination of the concentration of an a chemical in blood, comprising: a plurality of microneedles, each microneedle being adapted to puncture skin and to draw blood; and a test area in fluid communication (fluid communication) with the microneedles, the test area containing a reagent being adapted to produce a reaction indicative of the concentration of a chemical in blood.

US10533994B2 Filed: 2006-03-24     Issued: 2020-01-14 Systems and methods of sample processing and fluid control in a fluidic system (Original Assignee) Theranos IP Co LLC     (Current Assignee) Theranos IP Co LLC Elizabeth A. Holmes, Shaunak Roy, Ian Gibbons, Shize Daniel Qi, Edmond Ku, Chris Todd, Melissa Takahashi, Bruce Johnson, Jeff Fenton, Keith Moravick, Uwe Springborn, Anthony Delacruz

JP2002010990A Filed: 2001-05-29     Issued: 2002-01-15 組織の電気的特性の計測 (Original Assignee) Given Imaging Ltd; ギブン・イメージング・リミテツド      Arkady Glukhovsky, アルカデイ・グルクホフスキイ

US10533994B2 CLAIM 1. A system for detecting the presence or absence of an analyte in a bodily fluid sample (前記生) obtained from a subject, comprising: a cartridge, comprising: a sample collection unit, comprising: a sample collection well configured to receive a portion of the sample; a metering channel in fluid communication with the sample collection well and configured such that the sample flows from the sample collection well into the metering channel; and a metering element comprising a mechanically movable portion configured to be movable from an open position that permits fluid communication between the sample collection well and the metering channel to a closed position that does not provide fluid communication between the sample collection well, thereby isolating a specific volume of the sample in the metering channel; a lysing assembly configured to lyse cells present in the sample; and an assay assembly comprising a reaction site containing a reactant able to react with the analyte to yield a detectable signal indicative of the presence or absence of the analyte; and a reader assembly comprising: a detection assembly configured to detect the signal; and a communication assembly configured to receive an assay protocol in response to receiving an identity of the cartridge from an external device, the external device being separate from the reader assembly, the communication assembly further configured to transmit the signal to the external device.

JP2002010990A CLAIM 2 【請求項２】 前記生 (bodily fluid sample) 物学的組織内の関心のあるエリア をイメージングするためのイメージャをさらに備える請 求項１に記載の装置。

US10533994B2 Filed: 2006-03-24     Issued: 2020-01-14 Systems and methods of sample processing and fluid control in a fluidic system (Original Assignee) Theranos IP Co LLC     (Current Assignee) Theranos IP Co LLC Elizabeth A. Holmes, Shaunak Roy, Ian Gibbons, Shize Daniel Qi, Edmond Ku, Chris Todd, Melissa Takahashi, Bruce Johnson, Jeff Fenton, Keith Moravick, Uwe Springborn, Anthony Delacruz	JP2001319560A Filed: 2000-10-12     Issued: 2001-11-16 電子放出素子およびそれを利用した電子源、電界放出型画像表示装置、蛍光灯、並びにそれらの製造方法 (Original Assignee) Matsushita Electric Ind Co Ltd; 松下電器産業株式会社      Koji Akiyama, Toru Kawase, Hideo Kurokawa, Tetsuya Shiratori, 透 川瀬, 哲也 白鳥, 浩二 秋山, 英雄 黒川
US10533994B2 CLAIM 1. A system for detecting the presence or absence of an analyte in a bodily fluid sample obtained from a subject, comprising: a cartridge, comprising: a sample collection unit, comprising: a sample collection well configured to receive a portion of the sample; a metering channel in fluid communication with the sample collection well and configured such that the sample flows from the sample collection well into the metering channel; and a metering element comprising a mechanically movable portion configured to be movable from an open position that permits fluid communication between the sample collection well and the metering channel to a closed position that does not provide fluid communication between the sample collection well, thereby isolating a specific volume of the sample in the metering channel; a lysing assembly configured to lyse cells present in the sample; and an assay assembly comprising a reaction site containing a reactant able to react with the analyte to yield a detectable signal indicative of the presence or absence of the analyte; and a reader assembly comprising: a detection assembly configured to detect the signal; and a communication assembly (少なくとも１) configured to receive an assay protocol in response to receiving an identity of the cartridge from an external device, the external device being separate from the reader assembly, the communication assembly further configured to transmit the signal to the external device.	JP2001319560A CLAIM 51 【請求項５１】 多足形状粒子である第１の粒子と第２ の粒子とからなる混成粒子を含む冷陰極部材と、 前記電冷陰極部材に電子を供給する電子搬送部材と、 が支持基材上に設けられた電子放出素子であって、 前記第１の粒子は、少なくとも１ (communication assembly) 本の足を空間に突出さ せ、残りの足の先端部分を介して前記電子搬送部材に電 気接続され、 前記第２の粒子は導電性を有し、前記第１の粒子の足も と近傍に存在して前記第１の粒子と前記電子搬送部材と の電気接続を増強している、 ことを特徴とする電子放出素子。
US10533994B2 CLAIM 4. The system of claim 2 , wherein the sample collection unit further comprises: a dilution chamber (制御回路と) in fluidic communication with the metering channel, wherein the dilution chamber is configured to store a diluent and comprises a port engaging pressure means transferring the diluent from the dilution chamber into the metering channel.	JP2001319560A CLAIM 78 【請求項７８】 電子放出素子と、前記電子放出素子を 制御する制御回路と (dilution chamber) を少なくとも備えた電子源であっ て、 前記電子放出素子が、請求項４４に記載の電子放出素子 である、 ことを特徴とする電子源。

US10533994B2 Filed: 2006-03-24     Issued: 2020-01-14 Systems and methods of sample processing and fluid control in a fluidic system (Original Assignee) Theranos IP Co LLC     (Current Assignee) Theranos IP Co LLC Elizabeth A. Holmes, Shaunak Roy, Ian Gibbons, Shize Daniel Qi, Edmond Ku, Chris Todd, Melissa Takahashi, Bruce Johnson, Jeff Fenton, Keith Moravick, Uwe Springborn, Anthony Delacruz

JP2001165752A Filed: 1999-12-06     Issued: 2001-06-22 血清量測定装置および測定方法 (Original Assignee) Hitachi Ltd; 株式会社日立製作所      Toshiyuki Ikeda, Tatsutoshi Imaoka, Toshiyuki Tanaka, 龍勇 今岡, 俊幸 池田, 利幸 田中

US10533994B2 CLAIM 1. A system for detecting the presence or absence of an analyte in a bodily fluid sample obtained from a subject, comprising: a cartridge, comprising: a sample collection unit, comprising: a sample collection well configured to receive a portion of the sample; a metering channel in fluid communication with the sample collection well and configured such that the sample flows from the sample collection well into the metering channel; and a metering element comprising a mechanically movable portion configured to be movable from an open position that permits fluid communication between the sample collection well and the metering channel to a closed position that does not provide fluid communication between the sample collection well, thereby isolating a specific volume of the sample in the metering channel; a lysing assembly configured to lyse cells present in the sample; and an assay assembly comprising a reaction site containing a reactant able to react with the analyte to yield a detectable signal indicative of the presence or absence of the analyte; and a reader assembly comprising: a detection assembly (検出手段) configured to detect the signal; and a communication assembly configured to receive an assay protocol in response to receiving an identity of the cartridge from an external device, the external device being separate from the reader assembly, the communication assembly further configured to transmit the signal to the external device.

JP2001165752A CLAIM 1 【請求項１】血液検体の画像を取り込んで血清成分の画 像を取り出す血清量測定装置において、 試験管中の血液の画像の３原色信号を取り込む画像入力 手段と、 前記画像から特徴部位の色度境界を抽出する抽出手段 と、 色度境界の連続性を検出して血清成分の上下境界位置を 特定する境界特定手段と、 特定された少なくとも上下境界位置に基づいて決定され た血清領域内の血清成分の画像を取り込む画像入力手段 と、 取り込んだ画像から色度不均一領域を検出する色度不均 一領域検出手段 (detection assembly) とを含んで構成されることを特徴とする 血清量測定装置。

US10533994B2 Filed: 2006-03-24     Issued: 2020-01-14 Systems and methods of sample processing and fluid control in a fluidic system (Original Assignee) Theranos IP Co LLC     (Current Assignee) Theranos IP Co LLC Elizabeth A. Holmes, Shaunak Roy, Ian Gibbons, Shize Daniel Qi, Edmond Ku, Chris Todd, Melissa Takahashi, Bruce Johnson, Jeff Fenton, Keith Moravick, Uwe Springborn, Anthony Delacruz

EP1106244A2 Filed: 2000-03-03     Issued: 2001-06-13 Chemical processing microsystems and controlling reaction conditions in same (Original Assignee) Symyx Technologies Inc     (Current Assignee) Symyx Technologies Inc S. Howard Bergh, Shenheng Guan

US10533994B2 CLAIM 1. A system for detecting the presence or absence of an analyte in a bodily fluid sample obtained from a subject, comprising: a cartridge, comprising: a sample collection unit, comprising: a sample collection well configured to receive a portion of the sample; a metering channel in fluid communication (fluid communication) with the sample collection well and configured such that the sample flows from the sample collection well into the metering channel; and a metering element comprising a mechanically movable portion configured to be movable from an open position that permits fluid communication between the sample collection well and the metering channel to a closed position that does not provide fluid communication between the sample collection well, thereby isolating a specific volume of the sample in the metering channel; a lysing assembly configured to lyse cells present in the sample; and an assay assembly comprising a reaction site containing a reactant able to react with the analyte to yield a detectable signal indicative of the presence or absence of the analyte; and a reader assembly comprising: a detection assembly configured to detect the signal; and a communication assembly configured to receive an assay protocol in response to receiving an identity of the cartridge from an external device, the external device being separate from the reader assembly, the communication assembly further configured to transmit the signal to the external device.

EP1106244A2 CLAIM 1 A chemical processing microsystem comprising four or more microreactors, each of the four or more microreactors comprising a surface defining a reaction cavity for carrying out a chemical reaction, the reaction cavity having a volume of not more than about 3 ml, an inlet port in fluid communication (fluid communication) with the reaction cavity, and an outlet port in fluid communication with the reaction cavity, and a fluid distribution system for supplying one or more reactants from one or more external reactant sources to the inlet port of each of the four or more microreactors and for discharging a reactor effluent from the outlet port of each of the four or more microreactors to one or more external effluent sinks, characterized in that the reaction cavity of each of the four or more microreactors has a geometry defined by ratios of distances X, Y, and Z measured within the reaction cavity along three mutually orthogonal lines having a common point of intersection at a midpoint of the longest line, Z, the X:Z and Y:Z ratios each ranging from about 1:2 to about 1:1.

US10533994B2 Filed: 2006-03-24     Issued: 2020-01-14 Systems and methods of sample processing and fluid control in a fluidic system (Original Assignee) Theranos IP Co LLC     (Current Assignee) Theranos IP Co LLC Elizabeth A. Holmes, Shaunak Roy, Ian Gibbons, Shize Daniel Qi, Edmond Ku, Chris Todd, Melissa Takahashi, Bruce Johnson, Jeff Fenton, Keith Moravick, Uwe Springborn, Anthony Delacruz

EP1086719A1 Filed: 2000-08-16     Issued: 2001-03-28 Method and device for abrading skin (Original Assignee) Becton Dickinson and Co     (Current Assignee) Becton Dickinson and Co Carl Randolph Bock, Burton H. Sage, Jr.

US10533994B2 CLAIM 10. The system of claim 1 , wherein the reaction site of the assay assembly is in fluidic communication with the sample collection unit, the reaction site containing a reactant that reacts with the analyte to yield a signal indicative of the presence of the analyte; and the assay assembly further comprises: a reagent chamber in fluidic communication with the reaction site, wherein the reagent chamber is configured to store an assay reagent; a fluidic channel connecting the reagent chamber with the reaction site; and an actuatable valve assembly (substantially straight line) configured to control the flow of reagent through the fluidic channel, wherein the valve assembly comprises a sealing element and actuator element, wherein the channel comprises first and second locations, wherein the sealing element positioned in the first location obstructs the flow of fluid through the channel and the sealing element positioned in the second location allows the flow of fluid through the channel, and wherein the actuator element is adapted to move the sealing element from the first location to the second location.

EP1086719A1 CLAIM 3 The method of claim 1, wherein said moving step comprises moving said microabrader in one direction in a substantially straight line (valve assembly) to form a plurality of spaced-apart grooves on the skin.

US10533994B2 Filed: 2006-03-24     Issued: 2020-01-14 Systems and methods of sample processing and fluid control in a fluidic system (Original Assignee) Theranos IP Co LLC     (Current Assignee) Theranos IP Co LLC Elizabeth A. Holmes, Shaunak Roy, Ian Gibbons, Shize Daniel Qi, Edmond Ku, Chris Todd, Melissa Takahashi, Bruce Johnson, Jeff Fenton, Keith Moravick, Uwe Springborn, Anthony Delacruz	JP2001065458A Filed: 1999-08-25     Issued: 2001-03-16 圧縮機 (Original Assignee) Matsushita Electric Ind Co Ltd; 松下電器産業株式会社      Shozo Funakura, Mitsuharu Matsuo, Fumitoshi Nishiwaki, Noriho Okaza, 典穂 岡座, 光晴 松尾, 正三 船倉, 文俊 西脇
US10533994B2 CLAIM 1. A system for detecting the presence or absence of an analyte in a bodily fluid sample obtained from a subject, comprising: a cartridge, comprising: a sample collection unit, comprising: a sample collection well configured to receive a portion of the sample; a metering channel in fluid communication with the sample collection well and configured such that the sample flows from the sample collection well into the metering channel; and a metering element comprising a mechanically movable portion configured to be movable from an open position (前記密閉容器) that permits fluid communication between the sample collection well and the metering channel to a closed position that does not provide fluid communication between the sample collection well, thereby isolating a specific volume of the sample in the metering channel; a lysing assembly configured to lyse cells present in the sample; and an assay assembly comprising a reaction site containing a reactant able to react with the analyte to yield a detectable signal indicative of the presence or absence of the analyte; and a reader assembly comprising: a detection assembly configured to detect the signal; and a communication assembly configured to receive an assay protocol in response to receiving an identity of the cartridge from an external device, the external device being separate from the reader assembly, the communication assembly further configured to transmit the signal to the external device.	JP2001065458A CLAIM 4 【請求項４】 密閉容器の内部に圧縮機構部と、前記圧 縮機構部を駆動する主軸と、前記主軸を支えるジャーナ ル軸受部と、前記ジャーナル軸受部を設置する軸受部品 と、前記主軸に取り付けた回転子と前記密閉容器 (open position) に取り 付けた固定子を含む電動機をそれぞれ備え、前記ジャー ナル軸受部にカーボンブッシュ材あるいは樹脂ブッシュ 材を用い、軸受端部の前記カーボンブッシュ材あるいは 樹脂ブッシュ材の板厚を軸受中央部より薄くし、軸受端 部で前記ジャーナル軸受部と軸受部品の間に隙間を設け たことを特徴とする圧縮機用ジャーナル軸受。
US10533994B2 CLAIM 3. The system of claim 2 , wherein the pin is configured to be movable from an open position (前記密閉容器) to a closed position, wherein the pin in the closed position blocks the metering channel.	JP2001065458A CLAIM 4 【請求項４】 密閉容器の内部に圧縮機構部と、前記圧 縮機構部を駆動する主軸と、前記主軸を支えるジャーナ ル軸受部と、前記ジャーナル軸受部を設置する軸受部品 と、前記主軸に取り付けた回転子と前記密閉容器 (open position) に取り 付けた固定子を含む電動機をそれぞれ備え、前記ジャー ナル軸受部にカーボンブッシュ材あるいは樹脂ブッシュ 材を用い、軸受端部の前記カーボンブッシュ材あるいは 樹脂ブッシュ材の板厚を軸受中央部より薄くし、軸受端 部で前記ジャーナル軸受部と軸受部品の間に隙間を設け たことを特徴とする圧縮機用ジャーナル軸受。

US10533994B2 Filed: 2006-03-24     Issued: 2020-01-14 Systems and methods of sample processing and fluid control in a fluidic system (Original Assignee) Theranos IP Co LLC     (Current Assignee) Theranos IP Co LLC Elizabeth A. Holmes, Shaunak Roy, Ian Gibbons, Shize Daniel Qi, Edmond Ku, Chris Todd, Melissa Takahashi, Bruce Johnson, Jeff Fenton, Keith Moravick, Uwe Springborn, Anthony Delacruz	EP0971039A2 Filed: 1999-06-24     Issued: 2000-01-12 Processes useful for nucleic acid amplification and sequencing, and for the production of nucleic acid having decreased thermodynamic stability (Original Assignee) Enzo Diagnostics Inc     (Current Assignee) Enzo Diagnostics Inc Jack Coleman, James J. Donegan, Elazar Rabbani, Jannis G. Stavrianopolous, Marleen Walner
US10533994B2 CLAIM 1. A system for detecting the presence or absence of an analyte in a bodily fluid (nucleic acid sequencing) sample (nucleic acid sequencing) obtained from a subject, comprising: a cartridge, comprising: a sample collection unit, comprising: a sample collection well configured to receive a portion of the sample; a metering channel in fluid communication with the sample collection well and configured such that the sample flows from the sample collection well into the metering channel; and a metering element comprising a mechanically movable portion configured to be movable from an open position that permits fluid communication between the sample collection well and the metering channel to a closed position that does not provide fluid communication between the sample collection well, thereby isolating a specific volume of the sample in the metering channel; a lysing assembly configured to lyse cells present in the sample; and an assay assembly comprising a reaction site (nucleic acid sequencing) containing a reactant able to react with the analyte to yield a detectable signal indicative of the presence or absence of the analyte; and a reader assembly comprising: a detection assembly configured to detect the signal; and a communication assembly configured to receive an assay protocol in response to receiving an identity of the cartridge from an external device, the external device being separate from the reader assembly, the communication assembly further configured to transmit the signal to the external device.	EP0971039A2 CLAIM 33 A post-termination labelling process for nucleic acid sequencing (bodily fluid sample, reaction site, assay reagent, bodily fluid) comprising the steps of: producing, in the presence of untagged or unlabeled substrates, untagged or unlabeled primer, polymerizing enzyme, buffer and an appropriate untagged or unlabeled terminator for each nucleotide base, nucleic acid fragments corresponding to said nucleic acid sequence of interest, wherein each of said terminators comprise a chemically reactive group that covalently binds to a tagged molecule under conditions that internal sequences are substantially non-reactive to said tagged molecules and said chemical reactions do not substantially interfere with separation of said fragments in a medium or matrix; separating the fragments produced in a medium or matrix; and detecting said separated fragments by detecting said tagged molecule in said medium or matrix.
US10533994B2 CLAIM 10. The system of claim 1 , wherein the reaction site (nucleic acid sequencing) of the assay assembly is in fluidic communication with the sample collection unit, the reaction site containing a reactant that reacts with the analyte to yield a signal indicative of the presence of the analyte; and the assay assembly further comprises: a reagent chamber in fluidic communication with the reaction site, wherein the reagent chamber is configured to store an assay reagent; a fluidic channel connecting the reagent chamber with the reaction site; and an actuatable valve assembly configured to control the flow of reagent through the fluidic channel, wherein the valve assembly comprises a sealing element and actuator element, wherein the channel comprises first and second locations, wherein the sealing element positioned in the first location obstructs the flow of fluid through the channel and the sealing element positioned in the second location allows the flow of fluid through the channel, and wherein the actuator element is adapted to move the sealing element from the first location to the second location.	EP0971039A2 CLAIM 33 A post-termination labelling process for nucleic acid sequencing (bodily fluid sample, reaction site, assay reagent, bodily fluid) comprising the steps of: producing, in the presence of untagged or unlabeled substrates, untagged or unlabeled primer, polymerizing enzyme, buffer and an appropriate untagged or unlabeled terminator for each nucleotide base, nucleic acid fragments corresponding to said nucleic acid sequence of interest, wherein each of said terminators comprise a chemically reactive group that covalently binds to a tagged molecule under conditions that internal sequences are substantially non-reactive to said tagged molecules and said chemical reactions do not substantially interfere with separation of said fragments in a medium or matrix; separating the fragments produced in a medium or matrix; and detecting said separated fragments by detecting said tagged molecule in said medium or matrix.
US10533994B2 CLAIM 17. The system of claim 10 , wherein the sample of bodily fluid (nucleic acid sequencing) is less than 50 μl.	EP0971039A2 CLAIM 33 A post-termination labelling process for nucleic acid sequencing (bodily fluid sample, reaction site, assay reagent, bodily fluid) comprising the steps of: producing, in the presence of untagged or unlabeled substrates, untagged or unlabeled primer, polymerizing enzyme, buffer and an appropriate untagged or unlabeled terminator for each nucleotide base, nucleic acid fragments corresponding to said nucleic acid sequence of interest, wherein each of said terminators comprise a chemically reactive group that covalently binds to a tagged molecule under conditions that internal sequences are substantially non-reactive to said tagged molecules and said chemical reactions do not substantially interfere with separation of said fragments in a medium or matrix; separating the fragments produced in a medium or matrix; and detecting said separated fragments by detecting said tagged molecule in said medium or matrix.

US10533994B2 Filed: 2006-03-24     Issued: 2020-01-14 Systems and methods of sample processing and fluid control in a fluidic system (Original Assignee) Theranos IP Co LLC     (Current Assignee) Theranos IP Co LLC Elizabeth A. Holmes, Shaunak Roy, Ian Gibbons, Shize Daniel Qi, Edmond Ku, Chris Todd, Melissa Takahashi, Bruce Johnson, Jeff Fenton, Keith Moravick, Uwe Springborn, Anthony Delacruz	JPH11352094A Filed: 1998-06-11     Issued: 1999-12-24 電気化学分析素子 (Original Assignee) Matsushita Electric Ind Co Ltd; 松下電器産業株式会社      Makoto Ikeda, Shiro Nankai, Kiichi Watanabe, Toshihiko Yoshioka, 史朗 南海, 俊彦 吉岡, 信 池田, 基一 渡邊
US10533994B2 CLAIM 1. A system for detecting the presence or absence of an analyte in a bodily fluid sample obtained from a subject, comprising: a cartridge, comprising: a sample collection unit, comprising: a sample collection well configured to receive a portion of the sample; a metering channel in fluid communication with the sample collection well and configured such that the sample flows from the sample collection well into the metering channel; and a metering element (開口部) comprising a mechanically movable portion configured to be movable from an open position that permits fluid communication between the sample collection well and the metering channel to a closed position that does not provide fluid communication between the sample collection well, thereby isolating a specific volume of the sample in the metering channel; a lysing assembly configured to lyse cells present in the sample; and an assay assembly comprising a reaction site containing a reactant able to react with the analyte to yield a detectable signal indicative of the presence or absence of the analyte; and a reader assembly comprising: a detection assembly configured to detect the signal; and a communication assembly configured to receive an assay protocol in response to receiving an identity of the cartridge from an external device, the external device being separate from the reader assembly, the communication assembly further configured to transmit the signal to the external device.	JPH11352094A CLAIM 5 【請求項５】 前記中空部の開口部 (metering element) の少なくとも一方 に、フィルタ層が配置された請求項１〜４のいずれかに 記載の電気化学分析素子。
US10533994B2 CLAIM 2. The system of claim 1 , wherein the metering element (開口部) comprises a pin.	JPH11352094A CLAIM 5 【請求項５】 前記中空部の開口部 (metering element) の少なくとも一方 に、フィルタ層が配置された請求項１〜４のいずれかに 記載の電気化学分析素子。

US10533994B2 Filed: 2006-03-24     Issued: 2020-01-14 Systems and methods of sample processing and fluid control in a fluidic system (Original Assignee) Theranos IP Co LLC     (Current Assignee) Theranos IP Co LLC Elizabeth A. Holmes, Shaunak Roy, Ian Gibbons, Shize Daniel Qi, Edmond Ku, Chris Todd, Melissa Takahashi, Bruce Johnson, Jeff Fenton, Keith Moravick, Uwe Springborn, Anthony Delacruz

EP0844475A2 Filed: 1997-11-20     Issued: 1998-05-27 Particle sizing apparatus (Original Assignee) Microbial Systems Ltd     (Current Assignee) CELLFACTS INSTRUMENTS LIMITED Michael Anthony Wood

US10533994B2 CLAIM 1. A system for detecting the presence or absence of an analyte in a bodily fluid sample obtained from a subject, comprising: a cartridge, comprising: a sample collection unit, comprising: a sample collection well configured to receive a portion of the sample; a metering channel in fluid communication (fluid communication) with the sample collection well and configured such that the sample flows from the sample collection well into the metering channel; and a metering element comprising a mechanically movable portion configured to be movable from an open position that permits fluid communication between the sample collection well and the metering channel to a closed position that does not provide fluid communication between the sample collection well, thereby isolating a specific volume of the sample in the metering channel; a lysing assembly configured to lyse cells present in the sample; and an assay assembly comprising a reaction site containing a reactant able to react with the analyte to yield a detectable signal indicative of the presence or absence of the analyte; and a reader assembly comprising: a detection assembly configured to detect the signal; and a communication assembly configured to receive an assay protocol in response to receiving an identity of the cartridge from an external device, the external device being separate from the reader assembly, the communication assembly further configured to transmit the signal to the external device.

EP0844475A2 CLAIM 47. Apparatus according to any of claims 43 to 46 wherein the fluid flow control means comprises fluid communication (fluid communication) to a reservoir of diluent and/or cleaning liquid, and/or pumps such as a peristaltic pump, and/or valves.

US10533994B2 Filed: 2006-03-24     Issued: 2020-01-14 Systems and methods of sample processing and fluid control in a fluidic system (Original Assignee) Theranos IP Co LLC     (Current Assignee) Theranos IP Co LLC Elizabeth A. Holmes, Shaunak Roy, Ian Gibbons, Shize Daniel Qi, Edmond Ku, Chris Todd, Melissa Takahashi, Bruce Johnson, Jeff Fenton, Keith Moravick, Uwe Springborn, Anthony Delacruz

JPH10132712A Filed: 1997-04-18     Issued: 1998-05-22 検体分析用具およびそれを用いた検体分析方法並びに検体分析装置 (Original Assignee) Kdk Corp; 株式会社京都第一科学      Yoshihiko Higuchi, Koji Hirayama, Masufumi Koike, Michio Naka, Hisashi Okuda, 道男 仲, 久 奥田, 益史 小池, 浩二 平山, 善彦 樋口

US10533994B2 CLAIM 1. A system for detecting the presence or absence of an analyte in a bodily fluid sample obtained from a subject, comprising: a cartridge, comprising: a sample collection unit, comprising: a sample collection well configured to receive a portion of the sample; a metering channel in fluid communication with the sample collection well and configured such that the sample flows from the sample collection well into the metering channel; and a metering element comprising a mechanically movable portion configured to be movable from an open position that permits fluid communication between the sample collection well and the metering channel to a closed position that does not provide fluid communication between the sample collection well, thereby isolating a specific volume of the sample in the metering channel; a lysing assembly configured to lyse cells present in the sample; and an assay assembly comprising a reaction site containing a reactant able to react with the analyte to yield a detectable signal indicative of the presence or absence of the analyte; and a reader assembly comprising: a detection assembly (検出手段) configured to detect the signal; and a communication assembly configured to receive an assay protocol in response to receiving an identity of the cartridge from an external device, the external device being separate from the reader assembly, the communication assembly further configured to transmit the signal to the external device.

JPH10132712A CLAIM 24 【請求項２４】 電気信号付与手段および電気信号検出 手段と、請求項１８記載の検体分析用具とからなる検体 分析装置であって、前記検体分析用具の作用極と前記電 気信号付与手段が接続され、前記検体分析用具の対極が 前記電気信号検出手段 (detection assembly) と接続されている検体分析装置。

US10533994B2 Filed: 2006-03-24     Issued: 2020-01-14 Systems and methods of sample processing and fluid control in a fluidic system (Original Assignee) Theranos IP Co LLC     (Current Assignee) Theranos IP Co LLC Elizabeth A. Holmes, Shaunak Roy, Ian Gibbons, Shize Daniel Qi, Edmond Ku, Chris Todd, Melissa Takahashi, Bruce Johnson, Jeff Fenton, Keith Moravick, Uwe Springborn, Anthony Delacruz	JPH1072628A Filed: 1997-07-09     Issued: 1998-03-17 エアバッグ用インフレーターの再利用 (Original Assignee) Autoliv Asp Inc; オートリブ エーエスピー，インコーポレイティド      Harry W Ii Miller, Jeff K Morley, ケイ．モーレイ ジェフ, ダブリュ．ミラー ザ セカンド ハリー
US10533994B2 CLAIM 1. A system for detecting the presence or absence of an analyte in a bodily fluid sample obtained from a subject, comprising: a cartridge, comprising: a sample collection unit, comprising: a sample collection well configured to receive a portion of the sample; a metering channel in fluid communication (該部品) with the sample collection well and configured such that the sample flows from the sample collection well into the metering channel; and a metering element comprising a mechanically movable portion configured to be movable from an open position that permits fluid communication between the sample collection well and the metering channel to a closed position that does not provide fluid communication between the sample collection well, thereby isolating a specific volume of the sample in the metering channel; a lysing assembly configured to lyse cells present in the sample; and an assay assembly comprising a reaction site containing a reactant able to react with the analyte to yield a detectable signal indicative of the presence or absence of the analyte; and a reader assembly comprising: a detection assembly configured to detect the signal; and a communication assembly configured to receive an assay protocol in response to receiving an identity of the cartridge from an external device, the external device being separate from the reader assembly, the communication assembly further configured to transmit the signal to the external device.	JPH1072628A CLAIM 1 【請求項１】 非アルミニウム金属部品に加え、ガスフ ィルターアッセンブリ及びガス発生剤物質を含む非金属 部品を備える、アルミニウム合金ハウジングを具備する エアバッグ用インフレーターからの金属有価物の回収法 であって、下記の工程を含む方法：エアバッグ用インフ レーターに、せん断操作を施し、該インフレーターを微 粉砕する工程；前記ガス発生剤物質を含む、せん断操作 からの、様々な金属及び非金属材料を分離しかつ回収す る工程；前述の分離かつ回収されたアルミニウム合金部 品を、ガス燃料で燃焼された溶解炉に供給する工程；前 記アルミニウム合金部品を、分離かつ回収されたガス発 生剤物質の少なくとも一部を、流入(inflow)ガス燃料に 供給することによって、該部品 (fluid communication, permits fluid communication) の溶融に十分な温度で加 熱し、該アルミニウム合金部品の溶融に必要な加熱容量 を提供する工程；及びアルミニウム合金を回収する工 程。
US10533994B2 CLAIM 4. The system of claim 2 , wherein the sample collection unit (金属部品) further comprises: a dilution chamber in fluidic communication with the metering channel, wherein the dilution chamber is configured to store a diluent and comprises a port engaging pressure means (アッセンブリ) transferring the diluent from the dilution chamber into the metering channel.	JPH1072628A CLAIM 1 【請求項１】 非アルミニウム金属部品 (sample collection unit) に加え、ガスフ ィルターアッセンブリ (port engaging pressure means) 及びガス発生剤物質を含む非金属 部品を備える、アルミニウム合金ハウジングを具備する エアバッグ用インフレーターからの金属有価物の回収法 であって、下記の工程を含む方法：エアバッグ用インフ レーターに、せん断操作を施し、該インフレーターを微 粉砕する工程；前記ガス発生剤物質を含む、せん断操作 からの、様々な金属及び非金属材料を分離しかつ回収す る工程；前述の分離かつ回収されたアルミニウム合金部 品を、ガス燃料で燃焼された溶解炉に供給する工程；前 記アルミニウム合金部品を、分離かつ回収されたガス発 生剤物質の少なくとも一部を、流入(inflow)ガス燃料に 供給することによって、該部品の溶融に十分な温度で加 熱し、該アルミニウム合金部品の溶融に必要な加熱容量 を提供する工程；及びアルミニウム合金を回収する工 程。
US10533994B2 CLAIM 5. The system of claim 4 , wherein the sample collection unit (金属部品) further comprises a mixing chamber in fluidic communication with the metering channel, the mixing chamber being configured to mix the predetermined portion of the sample with the diluent to yield a diluted sample.	JPH1072628A CLAIM 1 【請求項１】 非アルミニウム金属部品 (sample collection unit) に加え、ガスフ ィルターアッセンブリ及びガス発生剤物質を含む非金属 部品を備える、アルミニウム合金ハウジングを具備する エアバッグ用インフレーターからの金属有価物の回収法 であって、下記の工程を含む方法：エアバッグ用インフ レーターに、せん断操作を施し、該インフレーターを微 粉砕する工程；前記ガス発生剤物質を含む、せん断操作 からの、様々な金属及び非金属材料を分離しかつ回収す る工程；前述の分離かつ回収されたアルミニウム合金部 品を、ガス燃料で燃焼された溶解炉に供給する工程；前 記アルミニウム合金部品を、分離かつ回収されたガス発 生剤物質の少なくとも一部を、流入(inflow)ガス燃料に 供給することによって、該部品の溶融に十分な温度で加 熱し、該アルミニウム合金部品の溶融に必要な加熱容量 を提供する工程；及びアルミニウム合金を回収する工 程。
US10533994B2 CLAIM 6. The system of claim 5 , wherein the sample collection unit (金属部品) further comprises a filter configured to filter the diluted sample before it is assayed.	JPH1072628A CLAIM 1 【請求項１】 非アルミニウム金属部品 (sample collection unit) に加え、ガスフ ィルターアッセンブリ及びガス発生剤物質を含む非金属 部品を備える、アルミニウム合金ハウジングを具備する エアバッグ用インフレーターからの金属有価物の回収法 であって、下記の工程を含む方法：エアバッグ用インフ レーターに、せん断操作を施し、該インフレーターを微 粉砕する工程；前記ガス発生剤物質を含む、せん断操作 からの、様々な金属及び非金属材料を分離しかつ回収す る工程；前述の分離かつ回収されたアルミニウム合金部 品を、ガス燃料で燃焼された溶解炉に供給する工程；前 記アルミニウム合金部品を、分離かつ回収されたガス発 生剤物質の少なくとも一部を、流入(inflow)ガス燃料に 供給することによって、該部品の溶融に十分な温度で加 熱し、該アルミニウム合金部品の溶融に必要な加熱容量 を提供する工程；及びアルミニウム合金を回収する工 程。

US10533994B2 Filed: 2006-03-24     Issued: 2020-01-14 Systems and methods of sample processing and fluid control in a fluidic system (Original Assignee) Theranos IP Co LLC     (Current Assignee) Theranos IP Co LLC Elizabeth A. Holmes, Shaunak Roy, Ian Gibbons, Shize Daniel Qi, Edmond Ku, Chris Todd, Melissa Takahashi, Bruce Johnson, Jeff Fenton, Keith Moravick, Uwe Springborn, Anthony Delacruz	JPH09192218A Filed: 1996-01-16     Issued: 1997-07-29 血糖値管理システム (Original Assignee) Hitachi Ltd; 株式会社日立製作所      Toshiko Fujii, Masao Kan, Yutaka Masuzawa, Yuji Miyahara, Osamu Ozawa, Tsuyoshi Sonehara, 裕二 宮原, 理 小沢, 剛志 曽根原, 正男 管, 稔子 藤井, 裕 鱒沢
US10533994B2 CLAIM 1. A system for detecting the presence or absence of an analyte in a bodily fluid sample (該液体, 前記生) obtained from a subject, comprising: a cartridge, comprising: a sample collection unit, comprising: a sample collection well configured to receive a portion of the sample; a metering channel in fluid communication with the sample collection well and configured such that the sample flows from the sample collection well into the metering channel; and a metering element comprising a mechanically movable portion configured to be movable from an open position that permits fluid communication between the sample collection well and the metering channel to a closed position that does not provide fluid communication between the sample collection well, thereby isolating a specific volume of the sample in the metering channel; a lysing assembly configured to lyse cells present in the sample; and an assay assembly comprising a reaction site (操作部) containing a reactant able to react with the analyte to yield a detectable signal indicative of the presence or absence of the analyte; and a reader assembly comprising: a detection assembly (光検出) configured to detect the signal; and a communication assembly (少なくとも１) configured to receive an assay protocol in response to receiving an identity of the cartridge from an external device, the external device being separate from the reader assembly, the communication assembly further configured to transmit the signal to the external device.	JPH09192218A CLAIM 1 【請求項１】 生体に直接光を照射する少なくとも１ (communication assembly) 個 の光源と、生体から生ずる透過光，散乱光または光音響 信号を検出する光検出 (detection assembly) 器または音響センサを有する生体 物質濃度を測定する装置に、血糖値回復用液体の注入手 段および液体注入量制御手段を設けたことを特徴とする 血糖値管理システム。 JPH09192218A CLAIM 3 【請求項３】 前記液体注入量制御手段は、前記可圧手 段に回転または直線運動の動力を伝達するモータ、およ び、前記生 (bodily fluid sample) 体物質濃度測定装置からの信号に対応して前 記モータの動作を制御する制御回路から構成されること を特徴とする請求項２記載の血糖値管理システム。 JPH09192218A CLAIM 7 【請求項７】 検出部，信号処理部，液体注入部から構 成され、これらの３つの部分はフレキシブルな信号線で 接続され、前記検出部は、発振波長の極大値が１.５６ μｍ，２.０８μｍまたは２.２７μｍにある 少なくと も１個の半導体レーザと光検出器または音響検出器とを 有し、生体に直接光を照射して生体から生ずる透過光， 散乱光または光音響信号をそれぞれ前記光検出器または 音響検出器で検出し、前記信号線を介して前記信号処理 部に入力し、該信号処理部は、増幅器，コンピュータ， 記憶部，表示部，操作部 (reaction site) を有し、前記検出部から入力さ れた信号に基づいてグルコース濃度を算出し、その結果 を記憶，表示し、グルコース濃度の値に対応した信号を 前記液体注入部に入力し、該液体 (bodily fluid sample) 注入部は、生体刺入用 の針，インシュリンを保持する容器および容器中のイン シュリンに圧力をかける可圧手段から構成される液体注 入手段，前記可圧手段に回転または直線運動の動力を伝 達するモータ、および、前記信号処理部からの信号に対 応して前記モータの動作を制御する制御回路から構成さ れる液体注入量制御手段から成ることを特徴とする血糖 値管理システム。
US10533994B2 CLAIM 10. The system of claim 1 , wherein the reaction site (操作部) of the assay assembly is in fluidic communication with the sample collection unit, the reaction site containing a reactant that reacts with the analyte to yield a signal indicative of the presence of the analyte; and the assay assembly further comprises: a reagent chamber in fluidic communication with the reaction site, wherein the reagent chamber is configured to store an assay reagent; a fluidic channel connecting the reagent chamber with the reaction site; and an actuatable valve assembly configured to control the flow of reagent through the fluidic channel, wherein the valve assembly comprises a sealing element and actuator element, wherein the channel comprises first and second locations, wherein the sealing element positioned in the first location obstructs the flow of fluid through the channel and the sealing element positioned in the second location allows the flow of fluid through the channel, and wherein the actuator element is adapted to move the sealing element from the first location to the second location.	JPH09192218A CLAIM 7 【請求項７】 検出部，信号処理部，液体注入部から構 成され、これらの３つの部分はフレキシブルな信号線で 接続され、前記検出部は、発振波長の極大値が１.５６ μｍ，２.０８μｍまたは２.２７μｍにある 少なくと も１個の半導体レーザと光検出器または音響検出器とを 有し、生体に直接光を照射して生体から生ずる透過光， 散乱光または光音響信号をそれぞれ前記光検出器または 音響検出器で検出し、前記信号線を介して前記信号処理 部に入力し、該信号処理部は、増幅器，コンピュータ， 記憶部，表示部，操作部 (reaction site) を有し、前記検出部から入力さ れた信号に基づいてグルコース濃度を算出し、その結果 を記憶，表示し、グルコース濃度の値に対応した信号を 前記液体注入部に入力し、該液体注入部は、生体刺入用 の針，インシュリンを保持する容器および容器中のイン シュリンに圧力をかける可圧手段から構成される液体注 入手段，前記可圧手段に回転または直線運動の動力を伝 達するモータ、および、前記信号処理部からの信号に対 応して前記モータの動作を制御する制御回路から構成さ れる液体注入量制御手段から成ることを特徴とする血糖 値管理システム。

US10533994B2 Filed: 2006-03-24     Issued: 2020-01-14 Systems and methods of sample processing and fluid control in a fluidic system (Original Assignee) Theranos IP Co LLC     (Current Assignee) Theranos IP Co LLC Elizabeth A. Holmes, Shaunak Roy, Ian Gibbons, Shize Daniel Qi, Edmond Ku, Chris Todd, Melissa Takahashi, Bruce Johnson, Jeff Fenton, Keith Moravick, Uwe Springborn, Anthony Delacruz

JPH0980021A Filed: 1995-09-18     Issued: 1997-03-28 マルチキャピラリ電気泳動装置 (Original Assignee) Otsuka Pharmaceut Co Ltd; 大塚製薬株式会社      Masayoshi Funato, Hiroshi Nagashima, 拓 永嶌, 正好 船戸

US10533994B2 CLAIM 1. A system for detecting the presence or absence of an analyte in a bodily fluid sample obtained from a subject, comprising: a cartridge, comprising: a sample collection unit, comprising: a sample collection well configured to receive a portion of the sample; a metering channel in fluid communication with the sample collection well and configured such that the sample flows from the sample collection well into the metering channel; and a metering element comprising a mechanically movable portion configured to be movable from an open position that permits fluid communication between the sample collection well and the metering channel to a closed position that does not provide fluid communication between the sample collection well, thereby isolating a specific volume of the sample in the metering channel; a lysing assembly configured to lyse cells present in the sample; and an assay assembly comprising a reaction site containing a reactant able to react with the analyte to yield a detectable signal indicative of the presence or absence of the analyte; and a reader assembly comprising: a detection assembly (光検出) configured to detect the signal; and a communication assembly configured to receive an assay protocol in response to receiving an identity of the cartridge from an external device, the external device being separate from the reader assembly, the communication assembly further configured to transmit the signal to the external device.

JPH0980021A CLAIM 1 【請求項１】透光部が並列に保持された複数のキャピラ リと、前記複数のキャピラリの各透光部にそれぞれ光を 照射する複数の発光部と、前記複数の発光部をそれぞれ 異なる電気信号成分により駆動する発光駆動部と、前記 透光部を通した光を１つに集束する集束部と、集束され た光を検出する光検出 (detection assembly) 部と、前記光検出部により検出さ れた電気信号に含まれている各電気信号成分を分離する 信号処理部と、前記キャピラリに電圧を印加する電圧印 加部とを備えることを特徴とするマルチキャピラリ電気 泳動装置。

US10533994B2 Filed: 2006-03-24     Issued: 2020-01-14 Systems and methods of sample processing and fluid control in a fluidic system (Original Assignee) Theranos IP Co LLC     (Current Assignee) Theranos IP Co LLC Elizabeth A. Holmes, Shaunak Roy, Ian Gibbons, Shize Daniel Qi, Edmond Ku, Chris Todd, Melissa Takahashi, Bruce Johnson, Jeff Fenton, Keith Moravick, Uwe Springborn, Anthony Delacruz

JPH0968533A Filed: 1995-08-31     Issued: 1997-03-11 薬品投与量を表示可能な生化学物質測定装置 (Original Assignee) Brother Ind Ltd; ブラザー工業株式会社      Masaki Yamaguchi, 昌樹 山口

US10533994B2 CLAIM 1. A system for detecting the presence or absence of an analyte in a bodily fluid sample (前記生) obtained from a subject, comprising: a cartridge, comprising: a sample collection unit, comprising: a sample collection well configured to receive a portion of the sample; a metering channel in fluid communication with the sample collection well and configured such that the sample flows from the sample collection well into the metering channel; and a metering element comprising a mechanically movable portion configured to be movable from an open position that permits fluid communication between the sample collection well and the metering channel to a closed position that does not provide fluid communication between the sample collection well, thereby isolating a specific volume of the sample in the metering channel; a lysing assembly configured to lyse cells present in the sample; and an assay assembly comprising a reaction site containing a reactant able to react with the analyte to yield a detectable signal indicative of the presence or absence of the analyte; and a reader assembly comprising: a detection assembly (検出手段) configured to detect the signal; and a communication assembly (少なくとも１) configured to receive an assay protocol in response to receiving an identity of the cartridge from an external device, the external device being separate from the reader assembly, the communication assembly further configured to transmit the signal to the external device.

JPH0968533A CLAIM 1 【請求項１】 収集された生体の分泌液に含まれる所定 の生化学物質の濃度に関連する情報を検出する検出手段 (detection assembly) と、 前記所定の生化学物質に関して前記分泌液中の濃度に関 連する情報と血液中の濃度との対応情報を記憶する記憶 手段と、 前記検出手段により検出された前記生 (bodily fluid sample) 化学物質の濃度に 関連する情報と前記記憶手段に記憶された対応情報とに 基づき、血液中の前記生化学物質の濃度を算出する算出 手段と、 生体に投与すべき薬品の投与量を表示可能な表示手段 と、 前記算出手段により算出された前記生化学物質の濃度に 応じて前記表示手段に前記薬品の投与量を表示させる表 示制御手段とを備えたことを特徴とする薬品投与量を表 示可能な生化学物質測定装置。 JPH0968533A CLAIM 5 【請求項５】 前記検出手段は、前記生化学物質を反応 させる少なくとも１ (communication assembly) 種類の酵素と、前記反応により生成 される生成物の増減を検出するための電極とを備えたこ とを特徴とする請求項１乃至４のいずれかに記載の薬品 投与量を表示可能な生化学物質測定装置。

US10533994B2 Filed: 2006-03-24     Issued: 2020-01-14 Systems and methods of sample processing and fluid control in a fluidic system (Original Assignee) Theranos IP Co LLC     (Current Assignee) Theranos IP Co LLC Elizabeth A. Holmes, Shaunak Roy, Ian Gibbons, Shize Daniel Qi, Edmond Ku, Chris Todd, Melissa Takahashi, Bruce Johnson, Jeff Fenton, Keith Moravick, Uwe Springborn, Anthony Delacruz	JPH08334505A Filed: 1996-06-06     Issued: 1996-12-17 小型化全分析システム (Original Assignee) Hewlett Packard Co <Hp>; ヒューレット・パッカード・カンパニー      Fritz Bek, Patrick Kaltenbach, Laurie S Mittelstadt, Sally A Swedberg, Klaus E Witt, クラウス・イー・ウィット, サリー・エイ・スエドバーグ, パトリック・カルテンバック, フリッツ・ベク, ロウリー・エイ・ミッテルシュタット
US10533994B2 CLAIM 1. A system for detecting the presence or absence of an analyte in a bodily fluid sample obtained from a subject, comprising: a cartridge, comprising: a sample collection unit, comprising: a sample collection well configured to receive a portion of the sample; a metering channel in fluid communication with the sample collection well and configured such that the sample flows from the sample collection well into the metering channel; and a metering element comprising a mechanically movable portion configured to be movable from an open position that permits fluid communication between the sample collection well and the metering channel to a closed position that does not provide fluid communication between the sample collection well, thereby isolating a specific volume of the sample in the metering channel; a lysing assembly configured to lyse cells present in the sample; and an assay assembly comprising a reaction site containing a reactant able to react with the analyte to yield a detectable signal indicative of the presence or absence of the analyte; and a reader assembly comprising: a detection assembly configured to detect the signal; and a communication assembly (少なくとも１, 前記基) configured to receive an assay protocol in response to receiving an identity of the cartridge from an external device, the external device being separate from the reader assembly, the communication assembly further configured to transmit the signal to the external device.	JPH08334505A CLAIM 1 【請求項１】 小型化カラムデバイス（２）から成る小 型化全分析システム（２００）であって、（ａ）第１平 坦表面（６）及び第２平坦表面（８）の実質的に平坦な 対向表面をもつ基板（４）であり、 前記基 (communication assembly) 板（４）は、前記第１平坦表面（６）にレーザ切 削された第１マイクロチャネル（１０）を有するが、シ リコン又は二酸化ケイ素以外の材料から構成され、かつ 前記第１マイクロチャネル（１０）が少なくとも２つの 試料操作領域（２０２，２０４，２０６，２０８，２１ ０，２１２，２１４，２１６，２１８，２２０）から成 る、前記基板（４）と、（ｂ）前記第１平坦表面（６） 上に配置され、前記第１マイクロチャネル（１０）との 組合せで第１試料処理区画（１４）を形成するカバー板 （１２）であり、 試料操作領域（２０２，２０４，２０６，２０８，２１ ０，２１２，２１４，２１６，２１８，２２０）が試料 取り扱い要素（２１４，２１６，２１８，２２０）と流 体連絡して試料流路要素（２０２，２０４，２０６，２ ０８，２１０，２１２）を定めている、前記カバー板 （１２）と、（ｃ）第１試料処理区画（１４）に連絡 し、外部の流体源から該試料処理区画（１４）を通して 流体を通過させる、少なくとも１ (communication assembly) つの入口ポート（１ ８）と少なくとも１つの出口ポート（２２）と、を含ん で成ることを特徴とする小型化全分析システム。
US10533994B2 CLAIM 4. The system of claim 2 , wherein the sample collection unit (２０４) further comprises: a dilution chamber in fluidic communication with the metering channel, wherein the dilution chamber is configured to store a diluent and comprises a port engaging pressure means transferring the diluent from the dilution chamber into the metering channel.	JPH08334505A CLAIM 1 【請求項１】 小型化カラムデバイス（２）から成る小 型化全分析システム（２００）であって、（ａ）第１平 坦表面（６）及び第２平坦表面（８）の実質的に平坦な 対向表面をもつ基板（４）であり、 前記基板（４）は、前記第１平坦表面（６）にレーザ切 削された第１マイクロチャネル（１０）を有するが、シ リコン又は二酸化ケイ素以外の材料から構成され、かつ 前記第１マイクロチャネル（１０）が少なくとも２つの 試料操作領域（２０２，２０４ (sample collection unit) ，２０６，２０８，２１ ０，２１２，２１４，２１６，２１８，２２０）から成 る、前記基板（４）と、（ｂ）前記第１平坦表面（６） 上に配置され、前記第１マイクロチャネル（１０）との 組合せで第１試料処理区画（１４）を形成するカバー板 （１２）であり、 試料操作領域（２０２，２０４，２０６，２０８，２１ ０，２１２，２１４，２１６，２１８，２２０）が試料 取り扱い要素（２１４，２１６，２１８，２２０）と流 体連絡して試料流路要素（２０２，２０４，２０６，２ ０８，２１０，２１２）を定めている、前記カバー板 （１２）と、（ｃ）第１試料処理区画（１４）に連絡 し、外部の流体源から該試料処理区画（１４）を通して 流体を通過させる、少なくとも１つの入口ポート（１ ８）と少なくとも１つの出口ポート（２２）と、を含ん で成ることを特徴とする小型化全分析システム。
US10533994B2 CLAIM 5. The system of claim 4 , wherein the sample collection unit (２０４) further comprises a mixing chamber in fluidic communication with the metering channel, the mixing chamber being configured to mix the predetermined portion of the sample with the diluent to yield a diluted sample.	JPH08334505A CLAIM 1 【請求項１】 小型化カラムデバイス（２）から成る小 型化全分析システム（２００）であって、（ａ）第１平 坦表面（６）及び第２平坦表面（８）の実質的に平坦な 対向表面をもつ基板（４）であり、 前記基板（４）は、前記第１平坦表面（６）にレーザ切 削された第１マイクロチャネル（１０）を有するが、シ リコン又は二酸化ケイ素以外の材料から構成され、かつ 前記第１マイクロチャネル（１０）が少なくとも２つの 試料操作領域（２０２，２０４ (sample collection unit) ，２０６，２０８，２１ ０，２１２，２１４，２１６，２１８，２２０）から成 る、前記基板（４）と、（ｂ）前記第１平坦表面（６） 上に配置され、前記第１マイクロチャネル（１０）との 組合せで第１試料処理区画（１４）を形成するカバー板 （１２）であり、 試料操作領域（２０２，２０４，２０６，２０８，２１ ０，２１２，２１４，２１６，２１８，２２０）が試料 取り扱い要素（２１４，２１６，２１８，２２０）と流 体連絡して試料流路要素（２０２，２０４，２０６，２ ０８，２１０，２１２）を定めている、前記カバー板 （１２）と、（ｃ）第１試料処理区画（１４）に連絡 し、外部の流体源から該試料処理区画（１４）を通して 流体を通過させる、少なくとも１つの入口ポート（１ ８）と少なくとも１つの出口ポート（２２）と、を含ん で成ることを特徴とする小型化全分析システム。
US10533994B2 CLAIM 6. The system of claim 5 , wherein the sample collection unit (２０４) further comprises a filter configured to filter the diluted sample before it is assayed.	JPH08334505A CLAIM 1 【請求項１】 小型化カラムデバイス（２）から成る小 型化全分析システム（２００）であって、（ａ）第１平 坦表面（６）及び第２平坦表面（８）の実質的に平坦な 対向表面をもつ基板（４）であり、 前記基板（４）は、前記第１平坦表面（６）にレーザ切 削された第１マイクロチャネル（１０）を有するが、シ リコン又は二酸化ケイ素以外の材料から構成され、かつ 前記第１マイクロチャネル（１０）が少なくとも２つの 試料操作領域（２０２，２０４ (sample collection unit) ，２０６，２０８，２１ ０，２１２，２１４，２１６，２１８，２２０）から成 る、前記基板（４）と、（ｂ）前記第１平坦表面（６） 上に配置され、前記第１マイクロチャネル（１０）との 組合せで第１試料処理区画（１４）を形成するカバー板 （１２）であり、 試料操作領域（２０２，２０４，２０６，２０８，２１ ０，２１２，２１４，２１６，２１８，２２０）が試料 取り扱い要素（２１４，２１６，２１８，２２０）と流 体連絡して試料流路要素（２０２，２０４，２０６，２ ０８，２１０，２１２）を定めている、前記カバー板 （１２）と、（ｃ）第１試料処理区画（１４）に連絡 し、外部の流体源から該試料処理区画（１４）を通して 流体を通過させる、少なくとも１つの入口ポート（１ ８）と少なくとも１つの出口ポート（２２）と、を含ん で成ることを特徴とする小型化全分析システム。

US10533994B2 Filed: 2006-03-24     Issued: 2020-01-14 Systems and methods of sample processing and fluid control in a fluidic system (Original Assignee) Theranos IP Co LLC     (Current Assignee) Theranos IP Co LLC Elizabeth A. Holmes, Shaunak Roy, Ian Gibbons, Shize Daniel Qi, Edmond Ku, Chris Todd, Melissa Takahashi, Bruce Johnson, Jeff Fenton, Keith Moravick, Uwe Springborn, Anthony Delacruz

JPH07196314A Filed: 1993-12-28     Issued: 1995-08-01 チューブ状合成無機微粒子 (Original Assignee) Maruo Calcium Co Ltd; 丸尾カルシウム株式会社      Minoru Hanazaki, Kayoko Hashimoto, Shiro Motoyoshi, Hiroshi Shibata, 洋志 柴田, 佳代子 橋本, 嗣郎 源吉, 実 花崎

US10533994B2 CLAIM 1. A system for detecting the presence or absence of an analyte in a bodily fluid sample obtained from a subject, comprising: a cartridge, comprising: a sample collection unit, comprising: a sample collection well configured to receive a portion of the sample; a metering channel in fluid communication with the sample collection well and configured such that the sample flows from the sample collection well into the metering channel; and a metering element comprising a mechanically movable portion configured to be movable from an open position that permits fluid communication between the sample collection well and the metering channel to a closed position that does not provide fluid communication between the sample collection well, thereby isolating a specific volume of the sample in the metering channel; a lysing assembly configured to lyse cells present in the sample; and an assay assembly comprising a reaction site containing a reactant able to react with the analyte to yield a detectable signal indicative of the presence or absence of the analyte; and a reader assembly comprising: a detection assembly configured to detect the signal; and a communication assembly (少なくとも１) configured to receive an assay protocol in response to receiving an identity of the cartridge from an external device, the external device being separate from the reader assembly, the communication assembly further configured to transmit the signal to the external device.

JPH07196314A CLAIM 3 【請求項３】 合成無機微粒子が燐酸塩、フッ化塩、珪 酸塩、硫酸塩、炭酸塩、ペロブスカイト塩（ＭＴｉ Ｏ 3 、Ｍ＝２価の金属）、シュウ酸塩及び水酸化物であ るアルカリ土類金属塩、燐酸塩、珪酸塩及び水酸化物で あるアルミニウ塩、珪酸及び珪酸水和物からなる群から 選ばれる少なくとも１ (communication assembly) 種で主として構成される請求項１ 又は２記載のチューブ状合成無機微粒子。

US10533994B2 Filed: 2006-03-24     Issued: 2020-01-14 Systems and methods of sample processing and fluid control in a fluidic system (Original Assignee) Theranos IP Co LLC     (Current Assignee) Theranos IP Co LLC Elizabeth A. Holmes, Shaunak Roy, Ian Gibbons, Shize Daniel Qi, Edmond Ku, Chris Todd, Melissa Takahashi, Bruce Johnson, Jeff Fenton, Keith Moravick, Uwe Springborn, Anthony Delacruz	EP0637996A1 Filed: 1993-04-29     Issued: 1995-02-15 Microfabricated detection structures. (Original Assignee) University of Pennsylvania     (Current Assignee) University of Pennsylvania Peter Wilding, Larry J Kricka, Jay N Zemel
US10533994B2 CLAIM 1. A system for detecting the presence or absence of an analyte in a bodily fluid sample obtained from a subject, comprising: a cartridge, comprising: a sample collection unit, comprising: a sample collection well configured to receive a portion of the sample; a metering channel in fluid communication (fluid communication) with the sample collection well and configured such that the sample flows from the sample collection well into the metering channel; and a metering element comprising a mechanically movable portion configured to be movable from an open position that permits fluid communication between the sample collection well and the metering channel to a closed position that does not provide fluid communication between the sample collection well, thereby isolating a specific volume of the sample in the metering channel; a lysing assembly configured to lyse cells present in the sample; and an assay assembly comprising a reaction site containing a reactant able to react with the analyte to yield a detectable signal indicative of the presence or absence of the analyte; and a reader assembly comprising: a detection assembly configured to detect the signal; and a communication assembly configured to receive an assay protocol in response to receiving an identity of the cartridge from an external device, the external device being separate from the reader assembly, the communication assembly further configured to transmit the signal to the external device.	EP0637996A1 CLAIM 1. A device for detecting the presence of an analyte in a fluid sample, the device comprising a solid substrate microfabricated to define: a sample inlet port; and a mesoscale flow system comprising: a sample flow channel extending from said inlet port; and an analyte detection region in fluid communication (fluid communication) with said flow channel comprising a binding moiety for specifically binding said analyte, said detection region having a mesoscale dimension.
US10533994B2 CLAIM 14. The system of claim 10 , wherein the actuator element comprises a sealing member (said holding means) such that when the actuator element moves the sealing element the sealing member forms a substantially air tight seal such that the fluid can only flow through the channel.	EP0637996A1 CLAIM 23. The device of claim 1 further comprising an appliance- for use in combination with said substrate, said appliance comprising: means for holding said substrate, fluid input means interfitting with an inlet port on said substrate, and pump means for passing fluid through the flow system of said substrate when it is held in said holding means (sealing member) .
US10533994B2 CLAIM 15. The system of claim 14 wherein the actuator element is substantially pin shaped and the sealing member (said holding means) is an O-ring adapted to be placed around the actuator element.	EP0637996A1 CLAIM 23. The device of claim 1 further comprising an appliance- for use in combination with said substrate, said appliance comprising: means for holding said substrate, fluid input means interfitting with an inlet port on said substrate, and pump means for passing fluid through the flow system of said substrate when it is held in said holding means (sealing member) .

US10533994B2 Filed: 2006-03-24     Issued: 2020-01-14 Systems and methods of sample processing and fluid control in a fluidic system (Original Assignee) Theranos IP Co LLC     (Current Assignee) Theranos IP Co LLC Elizabeth A. Holmes, Shaunak Roy, Ian Gibbons, Shize Daniel Qi, Edmond Ku, Chris Todd, Melissa Takahashi, Bruce Johnson, Jeff Fenton, Keith Moravick, Uwe Springborn, Anthony Delacruz	EP0636685A2 Filed: 1994-07-19     Issued: 1995-02-01 Particulate foam control agents and their use (Original Assignee) Dow Corning SA     (Current Assignee) Dow Silicones Belgium SPRL Leonidas Kolaitis, Bertrand Louis Julien Lenoble
US10533994B2 CLAIM 1. A system for detecting the presence or absence of an analyte in a bodily fluid sample obtained from a subject, comprising: a cartridge, comprising: a sample collection unit, comprising: a sample collection well configured to receive a portion of the sample; a metering channel in fluid communication with the sample collection well and configured such that the sample flows from the sample collection well into the metering channel; and a metering element comprising a mechanically movable portion configured to be movable from an open position that permits fluid communication between the sample collection well and the metering channel to a closed position that does not provide fluid communication between the sample collection well, thereby isolating a specific volume of the sample in the metering channel; a lysing assembly configured to lyse cells present in the sample; and an assay assembly comprising a reaction site (6 carbon atoms) containing a reactant able to react with the analyte to yield a detectable signal indicative of the presence or absence of the analyte; and a reader assembly comprising: a detection assembly configured to detect the signal; and a communication assembly configured to receive an assay protocol in response to receiving an identity of the cartridge from an external device, the external device being separate from the reader assembly, the communication assembly further configured to transmit the signal to the external device.	EP0636685A2 CLAIM 6 A method according to any one of the preceding claims further characterised in that the organopolysiloxane polyoxyalkylene copolymer has a number of units X of the general formula R⁴ p Si-O 4-p/2 and at least one unit Y of the general formula R⁵R⁶ q -Si-O 3-q/2 wherein R⁴ denotes a monovalent hydrocarbon group having up to 24 carbon atoms, a hydrogen atom or a hydroxyl group, R⁶ denotes an aliphatic or aromatic hydrocarbon group having up to 24 carbon atoms, R⁵ denotes a group of the general formula A-(OZ) s -B, wherein Z is a divalent alkylene unit having from 2 to 8 carbon atoms, A denotes a divalent hydrocarbon radical having from 2 to 6 carbon atoms (reaction site) , optionally interrupted by oxygen, B denotes a capping unit, p and q have independently a value of 0, 1, 2 or 3 and s is an integer with a value of from 3 to 30.
US10533994B2 CLAIM 10. The system of claim 1 , wherein the reaction site (6 carbon atoms) of the assay assembly is in fluidic communication with the sample collection unit, the reaction site containing a reactant that reacts with the analyte to yield a signal indicative of the presence of the analyte; and the assay assembly further comprises: a reagent chamber in fluidic communication with the reaction site, wherein the reagent chamber is configured to store an assay reagent; a fluidic channel connecting the reagent chamber with the reaction site; and an actuatable valve assembly configured to control the flow of reagent through the fluidic channel, wherein the valve assembly comprises a sealing element and actuator element, wherein the channel comprises first and second locations, wherein the sealing element positioned in the first location obstructs the flow of fluid through the channel and the sealing element positioned in the second location allows the flow of fluid through the channel, and wherein the actuator element is adapted to move the sealing element from the first location to the second location.	EP0636685A2 CLAIM 6 A method according to any one of the preceding claims further characterised in that the organopolysiloxane polyoxyalkylene copolymer has a number of units X of the general formula R⁴ p Si-O 4-p/2 and at least one unit Y of the general formula R⁵R⁶ q -Si-O 3-q/2 wherein R⁴ denotes a monovalent hydrocarbon group having up to 24 carbon atoms, a hydrogen atom or a hydroxyl group, R⁶ denotes an aliphatic or aromatic hydrocarbon group having up to 24 carbon atoms, R⁵ denotes a group of the general formula A-(OZ) s -B, wherein Z is a divalent alkylene unit having from 2 to 8 carbon atoms, A denotes a divalent hydrocarbon radical having from 2 to 6 carbon atoms (reaction site) , optionally interrupted by oxygen, B denotes a capping unit, p and q have independently a value of 0, 1, 2 or 3 and s is an integer with a value of from 3 to 30.