IP Library Granted Patent US 9,719,990
Granted Patent B2
US 9,719,990 · App. 14/859,064 · Granted Aug 1, 2017

Systems and methods for multi-analysis

Inventors: Elizabeth A. Holmes (Palo Alto, CA); Ian Gibbons; Paul Patel (Palo Alto, CA); Samartha Anekal (Palo Alto, CA)
Assignee: Theranos, Inc.
G01N33/54366B01L3/021B01L3/5082B01L7/52B01L9/06B01L9/543C12Q1/6883C12Q1/70G01N15/1475G01N21/25G01N33/54306G01N33/54313G01N33/56983G01N33/80G01N35/00029G01N35/00069G01N35/00871G01N35/026G01N35/04G01N35/10G01N35/1011G01N35/1065G01N35/1072B01L9/52B01L2300/1827B01L2300/1855G01N2015/008G01N2015/1486G01N2035/00138G01N2035/00326G01N2035/00356G01N2035/00366G01N2035/00425G01N2035/00495G01N2035/0449G01N2035/0474G01N2035/0486G01N2035/0491G01N2201/024G01N2201/04Y10T436/111666Y10T436/113332
View Patent ↗
Loading inventors, assignments & file history…
Monitor This Case
Get email alerts when status or documents change.
Order Certified Copies
Most orders are placed with the USPTO same day — all within 24 business hours.
Order via The Patent Place →
Pre-filled with this patent's details
Quick Facts
Patent No.
US 9,719,990
App. No.
14/859,064
Granted
Aug 1, 2017
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 (41)

1. A method of performing a plurality of general chemistry assays on a blood sample obtained from a subject, comprising:

(i) receiving in a biological sample processing device a cartridge comprising the blood sample obtained from a subject, wherein the blood sample is about 200 μl or less and the cartridge further comprises:

at least 14 cuvettes for performing at least 14 general chemistry assays to detect at least 14 different analytes, wherein at least one general chemistry assay is performed in each of the cuvettes; and

all reagents for performing the at least 14 general chemistry assays, wherein the all reagents comprises at least an inert liquid and a chromogen for each of the at least 14 general chemistry assays, and wherein the inert liquid is immiscible with and has a lower density than the sample;

wherein the biological sample processing device comprises:

at least one detection unit selected from a luminometer and a spectrophotometer; and

a pipette comprising a plurality of pipette heads, wherein at least one pipette head is (a) capable of engaging with at least one pipette tip and aspirating and dispensing a fluid and (b) capable of engaging with at least one cuvette and moving the at least one cuvette from a first location to a second location within the device;

(ii) aspirating at least a portion of the biological sample with the pipette and dispensing the at least a portion of the biological sample to each of the at least 14 cuvettes with the pipette;

(iii) aspirating a chromogen with the pipette and dispensing the chromogen to a cuvette with the pipette, and repeating the aspirating and dispensing step with the remaining chromogens, wherein each of the at least 14 cuvettes comprises the inert liquid and the inert liquid forms a layer on top of the sample and chromogen;

(iv) engaging the at least one pipette head with at least one of the at least 14 cuvettes and moving with the pipette head the at least one cuvette from the cartridge to the at least one detection unit;

and

(v) detecting signals indicative of the presence or absence of the at least 14 different analytes with the at least one detection unit;

wherein the at least 14 general chemistry assays do not use an antibody and do not assay for a nucleic acid, and the at least 14 different analytes comprise glucose, calcium, albumin, total protein, sodium, potassium, chloride, carbon dioxide, creatinine, blood urea nitrogen (BUN), alkaline phosphatase (ALP), alanine aminotransferase (ALT/GPT), aspartate aminotransferase LAST/GOT), and total bilirubin.

2. The method of claim 1 , wherein the device further comprises a centrifuge.

3. The method of claim 1 , wherein the cartridge further comprises the at least one pipette tip, and wherein the at least one pipette head engages with the at least one pipette tip for aspirating at least a portion of the blood sample and dispensing the at least a portion of the blood sample to the at least 14 cuvettes.

4. The method of claim 1 , wherein the blood sample is a blood sample obtained by a fingerstick.

5. The method of claim 2 , wherein the method comprises centrifuging the blood sample in the centrifuge in the biological sample processing device and obtaining a plasma or serum sample.

6. The method of claim 1 , wherein the cartridge further comprises at least one diluent for diluting the blood sample and the method further comprises diluting by the pipette the blood sample with the diluent.

7. The method of claim 1 , wherein the at least one detection unit is a luminometer.

8. The method of claim 1 , wherein the at least one detection unit is a spectrophotometer.

9. The method of claim 1 , wherein the biological sample processing device comprises at least two detection units, wherein a first detection unit is a luminometer and a second detection unit is a spectrophotometer.

10. The method of claim 1 , wherein the method comprises detecting the signal indicative of the presence of a first analyte with the luminometer and the signal indicative of the presence of a second analyte with the spectrophotometer.

11. The method of claim 1 , wherein the method comprises incubating the at least 14 different general chemistry assays at a temperature of about 37° C.

12. The method of claim 1 , wherein the method further comprises performing at least four additional general chemistry assays on the blood sample in the device to detect at least four additional different analytes, wherein the at least four additional different analytes comprises low density lipoprotein (LDL) cholesterol, high density lipoprotein (HDL) cholesterol, total cholesterol, and triglycerides.

13. A sample processing system for performing a plurality of general chemistry assays on a blood sample obtained from a subject, comprising:

an insertable and removable cartridge comprising (i) at least one receptacle for receiving the blood sample, wherein the at least one receptacle holds a sample of about 200 μl or less (ii) at least 14 cuvettes for performing at least 14 general chemistry assays to detect at least 14 different analytes; and (iii) all reagents for performing the at least 14 general chemistry assays, wherein the all reagents comprises at least an inert liquid and a chromogen for each of the at least 14 general chemistry assays, and wherein the inert liquid is immiscible with and has a lower density than the sample;

and a biological sample processing device comprising a cartridge receiving location, at least one detection unit selected from a luminometer and a spectrophotometer, and a pipette comprising a plurality of pipette heads, wherein at least one pipette head is (a) capable of engaging with at least one pipette tip and aspirating and dispensing a fluid and (b) capable of engaging with at least one cuvette and moving the at least one cuvette from a first location to a second location within the device

wherein the at least 14 general chemistry assays do not use an antibody and do not assay for a nucleic acid, and the at least 14 different analytes comprise glucose, calcium, albumin, total protein, sodium, potassium, chloride, carbon dioxide, creatinine, blood urea nitrogen (BUN), alkaline phosphatase (ALP), alanine aminotransferase (ALT/GPT), aspartate aminotransferase (AST/GOT), and total bilirubin.

14. The system of claim 13 , wherein the biological sample processing device further comprises a centrifuge.

15. The system of claim 13 , wherein the at least one detection unit is a luminometer.

16. The system of claim 13 , wherein the at least one detection unit is a spectrophotometer.

17. The system of claim 13 , wherein the biological sample processing device comprises at least two detection units, wherein a first detection unit is a luminometer and a second detection unit is a spectrophotometer.

18. The system of claim 13 , wherein the cartridge further comprises the at least one pipette tip.

19. The system of claim 13 , wherein the cartridge further comprises at least one diluent for diluting the biological sample.

20. The system of claim 13 , wherein the cartridge further comprises at least four additional cuvettes for performing at least four additional general chemistry assays on the blood sample to detect at least four additional different analytes, wherein the at least four additional different analytes comprise low density lipoprotein (LDL) cholesterol, high density lipoprotein (HDL) cholesterol, total cholesterol, and triglycerides.

21. The method of 1 , wherein a plurality of the at least 14 cuvettes forms a vessel strip, wherein the plurality of the at least 14 cuvettes in the vessel strip are fluidically isolated and commonly linked, and wherein the vessel strip comprises one or more pick-up interfaces for engaging with a pipette head.

22. The method of claim 21 , wherein the vessel strip comprises a single pick-up interface.

23. The method of claim 21 , wherein the vessel strip comprises at least two pick-up interfaces.

24. The system of claim 13 , wherein a plurality of the at least 14 cuvettes form a vessel strip, wherein the plurality of the at least 14 cuvettes in the vessel strip are fluidically isolated and commonly linked, and wherein the vessel strip comprises one or more pick-up interfaces for engaging with a pipette head.

25. The system of claim 24 , wherein the vessel strip comprises a single pick-up interface.

26. The system of claim 24 , wherein the vessel strip comprises at least two pick-up interfaces.

Assignments (5)
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 045101/0315 →
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 Feb 4, 2016
From: HOLMES, ELIZABETH A.; PATEL, PAUL; ANEKAL, SAMARTHA
To: THERANOS, INC.
Reel/Frame 037695/0895 →
Continuity (38)
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
Continuation In Part 13244947 · Sep 26, 2011
Continuation In Part 13244946 · Sep 26, 2011
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
Continuation In Part 13244947 · Sep 26, 2011
Continuation In Part 13244946 · Sep 26, 2011
Provisional Application 61766113 · Feb 18, 2013
Provisional Application 61766119 · Feb 18, 2013
Related Publication 20160033544A1 · Feb 4, 2016