IP Library Granted Patent US 10,598,654
Granted Patent B2
US 10,598,654 · App. 15/217,207 · Granted Mar 24, 2020

Modular point-of-care devices, systems, and uses thereof

Inventors: Tammy Burd (Newark, CA); Ian Gibbons (Newark, CA); Elizabeth A. Holmes (Palo Alto, CA); Gary Frenzel (Palo Alto, MD); Anthony Joseph Nugent (Dublin, CA)
Assignee: Theranos IP Company, LLC
G01N33/5304A61B5/15A61B5/151A61B5/150755B01J19/0046B01L3/0262B01L3/5025B01L3/527B01L7/52B01L9/543G01N1/38G01N33/5302G01N33/54326G01N33/54366G01N33/54386G01N33/56966G01N33/57484G01N33/6803G01N33/94G01N35/00732G01N35/00871G01N35/028G01N35/10G01N35/1065G01N35/1074G16H10/40A61B10/007A61B10/0038A61B10/0045A61B10/0051A61B10/0058A61B10/02A61B2010/0074A61B2010/0077B01J2219/005B01J2219/00283B01J2219/00292B01J2219/00315B01J2219/00369B01J2219/00371B01J2219/00385B01J2219/00466B01J2219/00495B01J2219/00693B01J2219/00702B01L3/021B01L7/5255B01L2200/04B01L2200/0689B01L2200/141B01L2200/148B01L2300/0654B01L2300/0829B01L2300/1805B01L2400/043G01N2035/0097G01N2035/00237G01N2035/00851G01N2035/00881G01N2035/1032G01N2035/1034G01N2035/1048G01N2333/475G01N2333/4737G01N2333/71G01N2333/912G01N2333/9129G01N2333/91205G01N2800/26G01N2800/60Y10T29/49826Y10T436/25375
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Quick Facts
Patent No.
US 10,598,654
App. No.
15/217,207
Granted
Mar 24, 2020
Kind
B2
Abstract

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.

Claims (38)

1. A method of measuring a volume of a liquid sample, comprising:

reacting a known quantity of a control analyte in the liquid sample with a reagent to yield a detectable signal indicative of the quantity of the control analyte; and

comparing the detectable signal indicative of the quantity of the control analyte with an expected signal,

wherein the expected signal is indicative of an expected volume of the liquid sample, and

wherein the comparison provides a measurement of the volume of the liquid sample being measured.

2. The method of claim 1 , wherein the control analyte is normally not present in the liquid sample in a detectable amount.

3. The method of claim 1 , further comprising verifying the volume of the liquid sample when the measurement of the volume of the liquid sample is within about 50% of the expected volume of the liquid sample.

4. The method of claim 1 , further comprising:

reacting the liquid sample containing a target analyte with a second reagent to yield a detectable signal indicative of the target analyte; and

measuring the quantity of the target analyte in the liquid sample based on the detectable signal indicative of the target analyte and the measurement of the volume of the liquid sample.

5. The method of claim 1 , wherein the liquid sample comprises a bodily fluid sample.

6. The method of claim 4 , wherein the control analyte does not react with the target analyte in the liquid sample.

7. The method of claim 4 , further comprising:

reacting a second liquid sample containing a target analyte with a second reagent to yield a detectable signal indicative of the target analyte; and

measuring the quantity of the target analyte in the second liquid sample based on the detectable signal indicative of the target analyte and the measurement of the volume of the liquid sample.

8. The method of claim 1 , wherein the control analyte is selected from the group consisting of: albumin, fluorescein, IgG, protein C, fluorescein-labeled albumin, fluorescein labeled IgG, anti-fluorescein, antidigoxigenin, digoxigenin-labeled albumin, digoxigenin-labeled IgG, biotinylated proteins, and non-human IgG.

9. The method of claim 1 , further comprising:

placing, by a fluid transfer device, the liquid sample in an addressable reagent unit of a removable cartridge to create a control solution, the addressable reagent unit including the control analyte;

transferring, by the fluid transfer device, the control solution to an addressable assay unit having a reaction site, wherein the reagent is disposed on the reaction site; and

detecting, by a detection assembly, the detectable signal indicative of the quantity of the control analyte.

10. A method of measuring a volume of a liquid sample using a bench-top, point-of-care system including an assay assembly, a fluid transfer device, and a detection assembly, the method comprising:

reacting a known quantity of a control analyte in the liquid sample with a reagent to yield a detectable signal indicative of the quantity of the control analyte; and

comparing the detectable signal indicative of the quantity of the control analyte with an expected signal, wherein the expected signal is indicative of an expected volume of the liquid sample; and

determining the volume of the liquid sample based on comparing the expected signal and the detectable signal.

11. The method of claim 10 , wherein reacting the known quantity of the control analyte in the liquid sample, comprises:

placing, by the fluid transfer device, the liquid sample in an addressable reagent unit of a removable cartridge to create a control solution, the addressable reagent unit including the control analyte;

transferring, by the fluid transfer device, the control solution to an addressable assay unit having a reaction site, wherein the reagent is disposed on the reaction site; and

detecting, by the detection assembly, the detectable signal indicative of the quantity of the control analyte.

12. The method of claim 10 , wherein the control analyte is normally not present in the liquid sample in a detectable amount.

13. The method of claim 10 , further comprising verifying the volume of the sample when the measurement of the volume of the liquid sample is within about 50% of the expected volume of the liquid sample.

14. The method of claim 10 , further comprising:

reacting the liquid sample containing a target analyte with a second reagent to yield a detectable signal indicative of the target analyte; and

measuring the quantity of the target analyte in the liquid sample based on of the detectable signal indicative of the target analyte and the measurement of the volume of the liquid sample.

15. The method of claim 14 , wherein the control analyte does not react with the target analyte in the liquid sample.

16. The method of claim 14 , further comprising

reacting a second liquid sample containing a target analyte with a second reagent to yield a detectable signal indicative of the target analyte; and

measuring the quantity of the target analyte in the second liquid sample based the detectable signal indicative of the target analyte and the measurement of the volume of the liquid sample.

17. The method of claim 10 , wherein the control analyte is selected from the group consisting of: albumin, fluorescein, IgG, protein C, fluorescein-labeled albumin, fluorescein labeled IgG, anti-fluorescein, antidigoxigenin, digoxigenin-labeled albumin, digoxigenin-labeled IgG, biotinylated proteins, and non-human IgG.

Assignments (5)
CHANGE OF NAME Recorded Apr 7, 2020
From: THERANOS IP COMPANY LLC
To: LABRADOR DIAGNOSTICS LLC
Reel/Frame 052329/0716 →
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 Aug 22, 2016
From: BURD, TAMMY; GIBBONS, IAN; HOLMES, ELIZABETH A.; FRENZEL, GARY; NUGENT, ANTHONY J.
To: THERANOS, INC.
Reel/Frame 039501/0234 →
Continuity (4)
Division 13326023 · Dec 14, 2011
Continuation 12244723 · Oct 2, 2008
Provisional Application 60997460 · Oct 2, 2007
Related Publication 20170014064A1 · Jan 19, 2017