IP Library Patent Application 15162038
Patent Application
App. No. 15/162,038

SYSTEMS AND METHODS FOR MULTI-ANALYSIS

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Quick Facts
Patent No.
US None
App. No.
15/162,038
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 (52)

1 - 8 . (canceled)

9 . A method for assaying a sample obtained from a subject, comprising:

receiving, in a biological sample processing device, a cartridge comprising a biological sample obtained from a subject, wherein the cartridge further comprises:

a vessel comprising the biological sample;

a reagent unit comprising an inert liquid barrier and a reagent solution for performing an assay for detecting the presence or absence of an analyte in a sample, wherein the inert liquid barrier is immiscible with and has a lower density than the reagent solution, and wherein the inert liquid barrier is capable of having (a) a molten state to prevent fluid from passing through the inert liquid barrier in the absence of an object inserted through the liquid barrier, and (b) a solid state to prevent fluid and the object from passing through the inert liquid barrier; and

at least one pipette tip;

wherein the vessel and the reagent unit are fluidically isolated and independently moveable;

wherein the biological sample processing device comprises:

a sample handling system comprising a pipette, wherein the pipette is configured to engage with the at least one pipette tip and the reagent unit;

a thermal control unit, wherein the thermal control unit is at a temperature such that the inert liquid barrier would be in a molten state; and

a detection unit for detecting an analyte in the sample;

and wherein prior to insertion of the cartridge, the cartridge was stored at a temperature such that the inert liquid barrier was in a solid state;

engaging the pipette with the reagent unit and moving the reagent unit to the thermal control unit and melting the inert liquid barrier to a molten state;

engaging the at least one pipette tip with the pipette;

bringing, with the pipette engaged with the at least one pipette tip, at least a portion of the sample into fluid communication with at least a portion of the reagent solution in the reagent unit;

obtaining a measurement by the detection unit for detecting the presence or absence of the analyte in the sample while the inert liquid barrier is in a molten state;

and removing the reagent unit from the thermal control unit with the pipette and placing the reagent unit in the cartridge, wherein the inert liquid barrier is in a solid state in the cartridge.

10 . The method of claim 9 , wherein the inert liquid barrier comprises a wax.

11 . The method of claim 9 , wherein the inert liquid barrier has a melting point between about 50 and about 60 degrees C.

12 . (canceled)

13 . (canceled)

14 . The method of claim 9 , wherein the inert liquid barrier comprises a long-chain fatty acid.

15 . (canceled)

16 . (canceled)

17 . The method of claim 9 , wherein the reagent solution is oxygen-depleted.

18 . The method of claim 9 , wherein the inert liquid barrier comprises an oxygen scavenger.

19 . The method of claim 9 , wherein the inert liquid barrier comprises a transition metal and an activating compound for promoting a reaction between the transition metal and oxygen.

20 . (canceled)

21 . A system comprising:

a cartridge comprising (i) a vessel for holding a biological sample, (ii) a reagent unit comprising at least one reagent solution for performing an assay on a sample and an inert liquid barrier, and (iii) at least one pipette tip; wherein the inert liquid barrier is immiscible with and has a lower density than the reagent solution, and wherein the inert liquid barrier is capable of having (a) a molten state to prevent fluid from passing through the inert liquid barrier in the absence of an object inserted through the liquid barrier, and (b) a solid state to prevent fluid and the object from passing through the inert liquid barrier; and wherein the vessel and the reagent unit are fluidically isolated and independently moveable; and

a biological sample processing device comprising a sample handling system comprising a pipette, wherein the pipette engages with the at least one pipette tip and the reagent unit, a thermal control unit, wherein the thermal control unit is at a temperature such that the inert liquid barrier would be in a molten state, and a detection unit for detecting an analyte in the sample.

22 . (canceled)

23 . The system of claim 21 , wherein the inert liquid barrier comprises a wax.

24 . The system of claim 21 , wherein the inert liquid barrier has a melting point between about 50 and 60 degrees C.

25 . (canceled)

26 . The system of claim 21 , wherein the inert liquid barrier comprises a long-chain fatty acid.

27 . (canceled)

28 . The system of claim 21 , wherein the reagent solution is oxygen-depleted.

29 . The system of claim 21 , wherein the inert liquid barrier comprises an oxygen scavenger.

30 . The system of claim 21 , wherein the inert liquid barrier comprises a transition metal and an activating compound for promoting a reaction between the transition metal and oxygen.

31 . A cartridge comprising:

a vessel for holding a biological sample;

a reagent unit comprising an inert liquid barrier and a reagent solution for performing an assay on the sample, wherein the inert liquid barrier is immiscible with and has a lower density than the reagent solution, and wherein the inert liquid barrier is capable of having (a) a molten state to prevent fluid from passing through the inert liquid barrier in the absence of an object inserted through the liquid barrier, and (b) a solid state to prevent fluid and the object from passing through the inert liquid barrier; and

at least one pipette tip;

wherein the vessel and the reagent unit are fluidically isolated and independently moveable.

32 . The cartridge of claim 31 , wherein the inert liquid barrier comprises a wax.

33 . The cartridge of claim 31 , wherein the inert liquid barrier has a melting point between about 50 and 60 degrees C.

34 . (canceled)

35 . The cartridge of claim 31 , wherein the inert liquid barrier comprises a long-chain fatty acid.

36 . The cartridge of claim 31 , wherein the reagent solution is oxygen-depleted.

37 . The cartridge of claim 31 , wherein the inert liquid barrier comprises an oxygen scavenger.

38 . (canceled)

Assignments (4)
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Jan 31, 2018
From: THERANOS, INC.
To: THERANOS IP COMPANY, LLC
Reel/Frame 045205/0686 →
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Jan 25, 2018
From: BALWANI, SUNNY; LATH, ADRIT; GANGAKHEDKAR, SUREKHA; LOO, ALEXANDER; CHEN, MICHAEL; PANGARKAR, CHINMAY; YOUNG, DANIEL; HOLMES, ELIZABETH A.; FRENZEL, GARY; FRANKOVICH, JOHN K.; ROY, JOY; PATEL, PAUL; ANEKAL, SAMARTHA; SMITH, TIMOTHY; GIBBONS, IAN
To: THERANOS, INC.
Reel/Frame 045147/0198 →
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 →