IP Library Granted Patent US 10,627,418
Granted Patent B2
US 10,627,418 · App. 15/161,533 · Granted Apr 21, 2020

Systems and methods for multi-analysis

Inventors: James Wasson (Palo Alto, CA); Pey-Jiun Ko (Redwood City, CA); Joy Roy (Palo Alto, CA); Elizabeth A. Holmes (Palo Alto, CA)
Assignee: Theranos IP Company, LLC
G01N35/0092B01L3/021B01L3/5082B01L3/50855B01L7/52B01L9/06B01L9/543C12Q1/42C12Q1/52C12Q1/6883C12Q1/70G01N15/1475G01N21/25G01N21/27G01N33/54306G01N33/54313G01N33/54366G01N33/56983G01N33/62G01N33/6827G01N33/80G01N33/92G01N35/00029G01N35/00069G01N35/00623G01N35/00871G01N35/026G01N35/04G01N35/10G01N35/1009G01N35/1011G01N35/1065G01N35/1072B01L9/52B01L2300/1827B01L2300/1855G01N33/5005G01N35/00G01N2015/008G01N2015/0073G01N2015/1006G01N2015/1486G01N2035/00138G01N2035/00148G01N2035/00237G01N2035/00306G01N2035/00326G01N2035/00356G01N2035/00366G01N2035/00425G01N2035/00435G01N2035/00495G01N2035/00633G01N2035/0449G01N2035/0474G01N2035/0486G01N2035/0491G01N2035/0493G01N2035/0494G01N2201/024G01N2201/04G01N2201/12Y10T436/111666Y10T436/113332
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Quick Facts
Patent No.
US 10,627,418
App. No.
15/161,533
Granted
Apr 21, 2020
Kind
B2
Abstract

Systems and methods are provided for sample processing. A device may be provided, capable of receiving the sample, and performing one or more of a sample preparation, sample assay, and detection step. The device may be capable of performing multiple assays. The device may comprise one or more modules that may be capable of performing one or more of a sample preparation, sample assay, and detection step. The device may be capable of performing the steps using a small volume of sample.

Claims (67)

1. A method of performing three or more assays for detecting a plurality of analytes in a biological sample from a subject, comprising:

providing a cartridge in a refrigerated condition at a temperature less than room temperature,

receiving the biological sample and the cartridge in a biological sample processing system, wherein:

a) the cartridge comprises:

a plurality of components including sample vessels, reagent units, and at least three assay units for performing the three or more assays to detect a plurality of analytes in the biological sample; and

b) the biological sample processing system comprises:

a sample handling system including a pipette; and

at least two detection units;

heating at least one portion of the cartridge using a movable heater on the biological sample processing system, wherein said heating comprises moving said movable heater from a first position to a second position wherein in the second position, at least a portion of the cartridge is inside the heater to pre-heat reagent units or assay units that are in the cartridge when the cartridge is in the biological sample processing system;

using said sample handling system for aliquoting at least a diluted portion of the sample into one of the plurality of said components while the cartridge remains inside the biological sample processing system;

decoupling one or more of said plurality of components from the cartridge while the cartridge remains inside the biological sample processing system to form one or more decoupled components;

performing in the biological sample processing system the three or more assays, wherein the three or more assays are performed at least partially in parallel and comprises leaving one or more of the one or more decoupled components of the cartridge at a location in the device separate from the cartridge;

detecting the plurality of analytes with at least one of the at least two detection unit in the biological sample processing system; and

after detecting the plurality of analytes, returning any decoupled components back to the cartridge while the cartridge remains inside the biological sample processing system;

wherein each of the reagent units is a container, a tube, a pipette tip, or a vessel;

wherein each of the assay units is a cuvette, a container, a tube, a pipette tip, or a vessel.

2. The method of claim 1 , wherein the biological sample is a blood sample.

3. The method of claim 2 , wherein the blood sample obtained from the subject is about 500 μl or less.

4. The method of claim 2 , wherein the three or more assays are performed from a single blood sample obtained from the subject.

5. The method of claim 2 , wherein the blood sample is a plasma sample.

6. The method of claim 1 , wherein the biological sample processing system comprises at least four assay units and performs four or more assays at least partially in parallel, wherein the four or more assays comprise a nucleic acid amplification, and immunoassay, and wherein the plurality of analytes comprise an antibody, antigen, nucleic acid, and cell.

7. The method of claim 6 , further comprising performing a cytometric assay and wherein the biological sample processing system further comprises a cytometer.

8. The method of claim 1 , wherein the biological sample processing system further comprises a centrifuge.

9. The method of claim 1 , wherein the biological sample processing system further comprises a housing.

10. The method of claim 9 , wherein the cartridge comprises the at least three assay units and all reagents for performing the three or more assays, and the housing comprises the sample handling system, the heater and the at least one of said at least two detection units.

11. The method of claim 10 , wherein the cartridge further comprises at least one tip and the sample handling system comprises at least one pipette nozzle, wherein the pipette nozzle is configured to engage with the at least one tip.

12. The method of claim 1 , where the cartridge in the refrigerated condition has temperature in the range of about 0° C. to about 8° C.

13. The method of claim 1 , where the cartridge in the refrigerated condition has temperature in the range of about −20° C. to about 8° C.

14. The method of claim 1 , wherein the heater comprises a thermoelectric device.

15. The method of claim 14 , wherein the heater further comprises a fan.

16. The method of claim 14 , wherein the heater further comprises a plurality of holes sized to engage portions of vessels in the cartridge.

17. The method of claim 14 , wherein the heater is located to direct heat towards an underside of the cartridge when the cartridge is in a cartridge receiving location.

18. The method of claim 14 , wherein heater is located to direct heat directly towards only a portion of an underside of the cartridge when the cartridge is in a cartridge receiving location.

19. A method of performing three or more assays for detecting a plurality of analytes in a biological sample from a subject, comprising:

providing a cartridge in a refrigerated condition at a temperature less than room temperature,

receiving the biological sample and the cartridge in a biological sample processing system, wherein:

b) the cartridge comprises:

a plurality of components including sample vessels, reagent units, and at least three assay units for performing the three or more assays to detect a plurality of analytes in the biological sample; and

b) the biological sample processing system comprises:

a sample handling system including a pipette; and

at least two detection units;

heating at least one portion of the cartridge using a movable heater on the biological sample processing system, wherein said heating comprises moving said movable heater from a first position to a second position wherein in the second position, at least a portion of the cartridge is inside the heater to pre-heat reagent units or assay units that are in the cartridge when the cartridge is in the biological sample processing system;

using said sample handling system for aliquoting at least a diluted portion of the sample into one of the plurality of said components while the cartridge remains inside the biological sample processing system;

decoupling one or more of said plurality of components from the cartridge while the cartridge remains inside the biological sample processing system to form one or more decoupled components;

performing in the biological sample processing system the three or more assays, wherein the three or more assays are performed at least partially in parallel and comprises leaving one or more of the one or more decoupled components of the cartridge at a location in the device separate from the cartridge;

detecting the plurality of analytes with at least one of the at least two detection unit in the biological sample processing system; and

after detecting the plurality of analytes, returning any decoupled components back to the cartridge while the cartridge remains inside the biological sample processing system;

wherein each of the reagent units is a container, a tube, a pipette tip, or a vessel;

wherein each of the assay units is a cuvette, a container, a tube, a pipette tip, or a vessel;

where the cartridge in the refrigerated condition has temperature in the range of about 2° C. to about 8° C.

20. A method of performing three or more assays for detecting a plurality of analytes in a biological sample from a subject, comprising:

providing a cartridge in a refrigerated condition at a temperature less than room temperature,

receiving the biological sample and the cartridge in a biological sample processing system, wherein:

c) the cartridge comprises:

a plurality of components including sample vessels, reagent units, and at least three assay units for performing the three or more assays to detect a plurality of analytes in the biological sample; and

b) the biological sample processing system comprises:

a sample handling system including a pipette; and

at least two detection units;

heating at least one portion of the cartridge using a movable heater on the biological sample processing system, wherein said heating comprises moving said movable heater from a first position to a second position wherein in the second position, at least a portion of the cartridge is inside the heater to pre-heat reagent units or assay units that are in the cartridge when the cartridge is in the biological sample processing system;

using said sample handling system for aliquoting at least a diluted portion of the sample into one of the plurality of said components while the cartridge remains inside the biological sample processing system;

decoupling one or more of said plurality of components from the cartridge while the cartridge remains inside the biological sample processing system to form one or more decoupled components;

performing in the biological sample processing system the three or more assays, wherein the three or more assays are performed at least partially in parallel and comprises leaving one or more of the one or more decoupled components of the cartridge at a location in the device separate from the cartridge;

detecting the plurality of analytes with at least one of the at least two detection unit in the biological sample processing system; and

after detecting the plurality of analytes, returning any decoupled components back to the cartridge while the cartridge remains inside the biological sample processing system;

wherein each of the reagent units is a container, a tube, a pipette tip, or a vessel;

wherein each of the assay units is a cuvette, a container, a tube, a pipette tip, or a vessel;

wherein the heater is mounted below a cartridge receiving location in the device.

Assignments (6)
CHANGE OF NAME Recorded Apr 15, 2020
From: THERANOS IP COMPANY, LLC
To: LABRADOR DIAGNOSTICS LLC
Reel/Frame 052410/0432 →
CHANGE OF NAME Recorded Apr 3, 2020
From: THERANOS IP COMPANY, LLC
To: LABRADOR DIAGNOSTICS LLC
Reel/Frame 052313/0011 →
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Jan 16, 2018
From: THERANOS, INC.
To: THERANOS IP COMPANY, LLC
Reel/Frame 045075/0310 →
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Dec 12, 2017
From: THERANOS INC.
To: THERANOS IP COMPANY, LLC
Reel/Frame 044838/0909 →
SECURITY INTEREST Recorded Dec 12, 2017
From: THERANOS IP COMPANY, LLC
To: FORTRESS CREDIT CORP.
Reel/Frame 044839/0568 →
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Mar 15, 2017
From: HOLMES, ELIZABETH A.; ROY, JOY; WASSON, JAMES; KO, PEY-JIUN
To: THERANOS, INC.
Reel/Frame 042012/0508 →
Continuity (21)
Continuation 14789930 · Jul 1, 2015
Continuation 14183500 · Feb 18, 2014
Continuation 14183503 · Feb 18, 2014
Continuation In Part 13769779 · Feb 18, 2013
Continuation In Part 13769820 · Feb 18, 2013
Continuation In Part PCTUS2012057155 · Sep 25, 2012
Continuation In Part PCTUS2011053188 · Sep 25, 2011
Continuation In Part PCTUS2011053189 · Sep 25, 2011
Continuation In Part 13244947 · Sep 26, 2011
Continuation In Part 13244946 · Sep 26, 2011
Continuation In Part 13244949 · Sep 26, 2011
Continuation In Part 13244956 · Sep 26, 2011
Continuation In Part 13244952 · Sep 26, 2011
Continuation In Part 13244950 · Sep 26, 2011
Continuation In Part 13244953 · Sep 26, 2011
Continuation In Part 13244954 · Sep 26, 2011
Continuation In Part PCTUS2011053188 · Sep 25, 2011
Continuation In Part PCTUS2011053189 · Sep 25, 2011
Provisional Application 61766113 · Feb 18, 2013
Provisional Application 61766119 · Feb 18, 2013
Related Publication 20160370396A1 · Dec 22, 2016
Cited By (1)
US 12,388,086