Modular point-of-care devices, systems, and uses thereof
원문보기
IPC분류정보
국가/구분
United States(US) Patent
등록
국제특허분류(IPC7판)
G01N-033/00
G01N-033/53
B01J-019/00
B01L-003/00
G01N-035/02
G01N-001/38
G01N-033/569
A61B-005/15
A61B-005/151
G01N-035/10
G01N-033/68
G01N-033/94
B01L-007/00
G01N-033/543
B01L-003/02
G01N-035/00
출원번호
US-0831734
(2015-08-20)
등록번호
US-9581588
(2017-02-28)
발명자
/ 주소
Burd, Tammy
Gibbons, Ian
Holmes, Elizabeth A.
Frenzel, Gary
Nugent, Anthony Joseph
출원인 / 주소
Theranos, Inc.
인용정보
피인용 횟수 :
0인용 특허 :
207
초록▼
The present invention provides devices and systems for use at the point of care. The methods devices of the invention are directed toward automatic detection of analytes in a bodily fluid. The components of the device are modular to allow for flexibility and robustness of use with the disclosed meth
The present invention provides devices and systems for use at the point of care. The methods devices of the invention are directed toward automatic detection of analytes in a bodily fluid. The components of the device are modular to allow for flexibility and robustness of use with the disclosed methods for a variety of medical applications.
대표청구항▼
1. A cartridge for detection of a plurality of analytes in a bodily fluid sample comprising: a housing comprising a plurality of defined locations, each of which defined locations being configured to receive a unit or a tip, wherein said unit is selected from a sample collection unit, a reagent unit
1. A cartridge for detection of a plurality of analytes in a bodily fluid sample comprising: a housing comprising a plurality of defined locations, each of which defined locations being configured to receive a unit or a tip, wherein said unit is selected from a sample collection unit, a reagent unit, and an assay unit;a sample collection unit configured to receive the bodily fluid sample;a plurality of reagent units configured to contain reagents for running chemical reactions for detecting analytes; anda plurality of assay units, each assay unit comprising an assay tip configured to engage with a fluid transfer device and having an interior surface defining an interior region configured to receive at least a portion of the sample from the sample collection unit and to receive reagent from a reagent unit, each assay tip comprising:i) an opening configured to allow the transfer of fluids in and out of the assay tip;ii) a clear and transparent portion configured to allow passage of an optical signal therethrough; andiii) an interior surface having immobilized thereon reactants for a chemical reaction that yields a detectable optical signal indicative of the presence of an analyte in the sample;wherein said assay units may be moved by said fluid transfer device to locations within said housing effective to place fluid within said sample collection unit or within reagent units into fluid communication with said interior regions of the assay units, and wherein sample, reagents, and reactants may contact each other effective to run chemical reactions and to provide optical signals for detecting said analytes, whereby said cartridge carries said sample collection unit, said plurality of reagent units, and said plurality of assay units in said plurality of defined locations of said housing. 2. The cartridge of claim 1, wherein the sample collection unit is configured to receive a volume of the bodily fluid sample of about 20 microliters or less. 3. The cartridge of claim 1, wherein the sample collection unit is configured to receive a volume of the bodily fluid sample that is a single drop of bodily fluid. 4. The cartridge of claim 1 further comprising a pretreatment unit configured to retrieve a portion of the bodily fluid sample for running a chemical reaction to detect an analyte. 5. The cartridge of claim 4, wherein the bodily fluid is a whole blood sample and the portion is plasma. 6. The cartridge of claim 4, further comprising a sample tip configured to collect at least a portion of the bodily fluid sample from said sample collection unit, and configured to distribute at least a portion of the bodily fluid sample to said pretreatment unit or said assay unit. 7. The cartridge of claim 6, further comprising a pretreatment tip configured to collect at least a portion of the sample from a pretreatment unit, wherein an assay unit is configured to receive sample from the sample tip or a pretreatment tip. 8. The cartridge of claim 1, wherein movement of an assay unit by said fluid transfer device effective to place said interior region of the assay unit into fluid communication with said sample collection unit or with a reagent unit comprises movement of an assay unit from defined one location of the cartridge to another defined location of the cartridge. 9. The cartridge of claim 8, wherein a reagent unit is configured to receive at least a portion of an assay tip. 10. The cartridge of claim 9 wherein an assay tip is configured to be moved from a first reagent unit to a second reagent unit. 11. The cartridge of claim 9 wherein an assay tip is configured to permit reagents to be distributed to the assay tip according to an aspiration-type or pipette-type action provided to the assay tip. 12. The cartridge of claim 1, wherein said reactants immobilized on said interior surface of an assay tip of an assay unit are selected from immunoassay reagents for running an immunoassay, nucleic acid assay reagents for running a nucleic acid assay, enzymes, substrates, and cofactors. 13. The cartridge of claim 1, wherein the bodily fluid sample comprises a bodily fluid selected from blood, serum, saliva, urine, gastric fluid, digestive fluid, tears, stool, semen, vaginal fluid, interstitial fluid, cerebrospinal fluid, and combinations thereof. 14. The cartridge of claim 1, wherein the assay units and the reagent units are addressable to indicate the location of the assay units and the reagent units on the cartridge. 15. The cartridge of claim 14, wherein a reagent unit is addressed to correspond to an assay unit in the cartridge. 16. A system for detection of an analyte in a bodily fluid sample comprising: i) a cartridge of claim 1; andii) a detection assembly for detecting the detectable signal regarding an analyte. 17. The system of claim 16 further comprising a fluid transfer device configured to move an assay unit from a first location to a second location, and a communication assembly for transmitting a protocol based on the analyte to be detected. 18. The system of claim 17, wherein the fluid transfer device comprises a programmable mechanical device. 19. The system of claim 18, wherein the fluid transfer device is automated. 20. The system of claim 18, wherein the fluid transfer device comprises a plurality of heads, wherein said heads are configured to engage assay units. 21. The system of claim 18, wherein the fluid transfer device comprises a programmable processor configured to direct fluid transfer of the bodily fluid sample from the sample collection unit to said assay unit and to direct fluid transfer of a reagent from a reagent unit to the assay unit. 22. The system of claim 21, wherein the configuration of the processor to direct fluid transfer effects a degree of dilution of the bodily fluid sample in the assay unit to bring signals indicative of the analyte being detected within a detectable range, such that said analyte is detectable with said system. 23. The system of claim 16 further comprising a heating block configured to receive an assay unit. 24. The system of claim 16, wherein the sample collection unit is configured for operable linkage to a magnetic block for separation of a plasma portion from a blood sample. 25. The cartridge of claim 1, wherein the assay tip comprises at least one end, and comprises an opening at one end from which sample or reagent may be transferred in and out of the assay tip. 26. A method of using an automated immunoassay for detecting an analyte present in a bodily fluid sample, comprising: i) providing a bodily fluid sample to the cartridge of claim 1;ii) performing an automated immunoassay for detecting said analyte in said bodily fluid sample;iii) detecting a signal provided by said automated immunoassay; andiv) transmitting a result of (iii) to an end user. 27. The method of claim 26, wherein the immunoassay is an ELISA. 28. The method of claim 27, wherein the result is transmitted wirelessly.
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이 특허에 인용된 특허 (207)
Shapiro Justin J. (c/o Labindustries ; Inc. ; 620 Hearst Ave. Berkeley CA 94710-1992), Adjustable volume pipette sampler.
Johnson, Kristianne E; Reasoner, Kelly J; Gardner, Jr., Richard Lynn; Coffin, Paul C, Apparatus and method for retrieving data related to a data cartridge in a media storage system.
Liljestrand John ; Zhang Jue ; Gambrel David R. ; Ivanov Sergey ; Wohlstadter Jacob N., Apparatus for carrying out electrochemiluminescence test measurements.
Smith Lloyd M. (Madison WI) Hood Leroy E. (Pasadena CA) Hunkapiller Michael W. (San Carlos CA) Hunkapiller Tim J. (Pasadena CA), Automated DNA sequencing technique.
Ortyn, William E.; Basiji, David A.; Morrissey, Philip; George, Thaddeus; Hall, Brian; Zimmerman, Cathleen; Perry, David, Blood and cell analysis using an imaging flow cytometer.
Hillman Robert S. (Cupertino CA) Cobb Michael E. (Sunnyvale CA) Allen Jim (Los Altos CA) Gibbons Ian (Menlo Park CA) Ostoich Vladimir (San Jose CA) Winfrey Laura J. (Belmont CA), Capillary flow device.
Dunn Chadwick M. (Gurnee IL) Grandone Cass J. (Lake Forest IL) Herchenbach Stephen L. (Grayslake IL) Nelson Robert J. (Highland Park IL) Tyranski James T. (Oakwood Hills IL) Zuck Gary L. (Prospect He, Carousel for assay specimen carrier.
Roger Hammer ; William Reid ; David Storvick ; Richard A. Riedel ; James S. Hutchinson ; Daniel Kennedy ; Douglas E. Boyd ; James Ramey ; John W. Stoughton ; Glen T. Mathews, Cartridge-based analytical instrument using centrifugal force/pressure for metering/transport of fluids.
Brown, Gene W.; Merritt, Steven J.; Calcaterra, Farrell F.; Beard, John H.; May, David F.; Krempel, Louis A., Centrifugal filter for removing soot from engine oil.
Hayter, Paul G.; Sharma, Manoj K.; Ohara, Timothy J.; Poulos, Darwin; Aquino, Maria, Diagnostic kit with a memory storing test strip calibration codes and related methods.
Carter Nigel F. (Oxon GB2) Chambers Geoffrey R. (Northwood Middlesex GB2) Hughes Graham J. (Oxford GB2) Scott Steven (Oxon GB2) Sanghera Gurdial S. (Oxford GB2) Watkin Jared L. (Oxon GB2), Electrochemical sensor.
Torti Victor A. (Brookline NH) Nelson Gary E. (Hollis NH) Keene Laurence (Brookline MA) Kalmakis George P. (Reading MA), Expandable multi-channel pipetter.
Queen Cary L. (Los Altos CA) Co Man Sung (Cupertino CA) Schneider William P. (Mountain View CA) Landolfi Nicholas F. (Milpitas CA) Coelingh Kathleen L. (San Francisco CA) Selick Harold E. (Belmont CA, Humanized immunoglobulins.
Farzad Pourahmadi ; William A. McMillan ; Jesus Ching ; Ronald Chang ; Lee A. Christel ; Gregory T. A. Kovacs ; M. Allen Northrup ; Kurt E. Petersen, Integrated fluid manipulation cartridge.
Ammann, Kelly G.; Burns, Ralph E.; Hansberry, Ernest V.; Horner, Glenn A.; Jakub, Cheryl A.; Kling, John E.; Nieglos, Donald J.; Schneider, Robert E.; Smith, Robert J., Method and apparatus for performing a magnetic separation purification procedure on a sample solution.
Ried Thomas ; MacVille Merryn V. E.,NLX ; Hopman Anton H. N.,NLX, Methods for assessing genetic and phenotypic markers by simultaneous multicolor visualization of chromogenic dyes using brightfield microscopy and spectral imaging.
John T. Santini, Jr. ; Charles E. Hutchinson ; Scott A. Uhland ; Michael J. Cima ; Robert S. Langer ; Dennis Ausiello, Microfabricated devices for the delivery of molecules into a carrier fluid.
Grtzel Michael (St-Sulpice CHX) Fraser David (Vevey CHX) Zakeeruddin Shaik M. (Renens CHX) Nazeeruddin Mohammed K. (Chavannes CHX), Mono, bis or tris(substituted 2,2′-bipyridine) iron, ruthenium, osmium or vanadium complexes and their methods of prepa.
Modlin, Douglas N.; Owicki, John C.; Petersen, Jon F.; French, Todd E.; Wright, Carl L.; Ruiz, Jeanne A.; Bechtel, Lorne E., Multi-mode light detection system.
Moring Stephen E. ; Bodner Kevin S. ; Halsey Jason H. ; Hoshizaki Jon ; Jackson Joseph ; Madden Alfred P. ; Oldham Mark F. ; Reed Mark T., Multi-well microfiltration apparatus.
Mark J. Rice ; Robert H. Sweat, Jr. ; James M. Rioux ; William T. Williams ; Wilson Routt, Non-invasive measurement of blood components using retinal imaging.
Queen Cary L. (Los Altos CA) Schneider William P. (Mountain View CA) Selick Harold E. (Belmont CA), Polynucleotides encoding improved humanized immunoglobulins.
Padmanabhan, Aravind; Cox, James A.; Fritz, Bernard S.; Rezachek, Tom M.; Reutiman, Peter L.; Bardell, Ron L.; Cabuz, Cleopatra, Portable sample analyzer system.
Mullis Kary B. (Kensington CA) Erlich Henry A. (Oakland CA) Arnheim Norman (Woodland Hills CA) Horn Glenn T. (Emeryville CA) Saiki Randall K. (Richmond CA) Scharf Stephen J. (Berkeley CA), Process for amplifying, detecting, and/or-cloning nucleic acid sequences.
Muller Uwe R. (Kendall County IL) Mika Lawrence J. (Naperville IL) Lindley Donald J. (Naperville IL) Wisner Ernest J. (Elgin IL), Processing of slide mounted material.
Holen, James T.; Hicaro, Jr., Enrique; Putterman, Caryn G.; Huang, Tung-Ming; Merkh, Carl W., Reaction cartridge and carousel for biological sample analyzer.
Cabilly Shmuel (Monrovia CA) Heyneker Herbert L. (Burlingame CA) Holmes William E. (Pacifica CA) Riggs Arthur D. (La Verne CA) Wetzel Ronald B. (San Francisco CA), Recombinant immunoglobin preparations.
Gelfand David H. (Oakland CA) Myers Thomas W. (Emeryville CA), Reverse transcription with thermostable DNA polymerase-high temperature reverse transcription.
Seaton William Ernest (Chesterfield MO) Shine David B. (University City MO) Drager Craig (Ballwin MO), Sample card transport method for biological sample testing machine.
Watson, Leslie Robert; Tschopp, Christoph Friedrich; Weaver, Ross Andrew; Henderson, Ian David; Kuiper, Pieter Adriaan; Decosterd, Christian Darrel, Sample distribution apparatus/system.
Campbell David A. ; Antonenko Valery V. ; Selick Harold E. ; Gavin Robert M. ; Ida Satoru ; Muir Arthur H., System and method for solid-phase parallel synthesis of a combinatorial collection of compounds.
Reichler Allen S. (Owing Mills MD) Antol David J. (Baldwin MD) Lamos Michael L. (Westminster MD) Bourdelle Peter A. (Glen Rock PA) Hildebrand Scott D. (Red Lion PA), System for nucleic acid based diagnostic assay.
Lair, Gary D.; Nguyen, Thanh N.; Li, Haitao; Li, Florence F.; Knight, Byron J.; Heinz, Robert E.; Macioszek, Jerzy A.; Davis, Christopher B.; Scalese, Robert F., System for performing multi-formatted assays.
Spence, Simon Jonathon; Grant, Richard Alexander; Peele, Timothy Doyle; Hunter, William Samuel; Abdelmoteleb, Ashraf F.; Kneen, David Thomas; Neil, Robert Alister; Harris, Simon, Systems and methods for processing samples in a closed container, and related devices.
Jaynes, Allison; Bucchieri, Vittorio G.; Schmidt, Albert L., Systems and methods for providing connection status and location information in a wireless networking environment.
Roy, Shaunak; Takahashi, Malissa; Gibbons, Ian; Ku, Edmond; Dang, Thanh; Burd, Tammy; Vollmer, Adam; Holmes, Elizabeth A., Systems and methods of fluidic sample processing.
Roy, Shaunak; Takahashi, Melissa; Gibbons, Ian; Ku, Edmond; Dang, Thanh; Burd, Tammy; Vollmer, Adam; Holmes, Elizabeth A., Systems and methods of fluidic sample processing.
Smith John A. (East Orange NJ) Miller Jack H. (Morristown NJ) Schilling Russell C. (Denville NJ) North ; Jr. Howard L. (Newfoundland NJ), Triac centrifuge.
Levene, Michael J.; Korlach, Jonas; Turner, Stephen W.; Craighead, Harold G.; Webb, Watt W., Zero-mode clad waveguides for performing spectroscopy with confined effective observation volumes.
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