IP Library Granted Patent US 9,999,889
Granted Patent B2
US 9,999,889 · App. 15/336,739 · Granted Jun 19, 2018

Cartridges, kits, and methods for enhanced detection and quantification of analytes

Inventors: Ayub Khattak (San Diego, CA); Clinton Sever (San Diego, CA); Paul Nelson (San Diego, CA); Ryan Cooper (San Diego, CA); Thomas Congdon (San Diego, CA); Justin Demartino (San Diego, CA); Raphael Shapiro (San Diego, CA); Mark Duncan (San Diego, CA)
Assignee: CUE HEALTH INC.
B01L3/508B01L3/5023B01L3/5027B01L3/5029B01L3/502715B01L3/502738B01L3/523G01N27/3273G01N33/54366G01N35/0098G01N35/10B01L2200/025B01L2200/027B01L2200/0668B01L2200/0684B01L2200/0689B01L2200/10B01L2200/14B01L2200/16B01L2300/023B01L2300/047B01L2300/069B01L2300/0627B01L2300/0645B01L2300/0663B01L2300/0672B01L2300/087B01L2300/0809B01L2300/0816B01L2300/0867B01L2300/1805B01L2300/1827B01L2400/0406B01L2400/0481B01L2400/0677C12Q1/6825
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Quick Facts
Patent No.
US 9,999,889
App. No.
15/336,739
Granted
Jun 19, 2018
Kind
B2
Abstract

Devices, systems, and methods for detecting molecules of interest within a collected sample are described herein. In certain embodiments, self-contained sample analysis systems are disclosed, which include a reusable reader component, a disposable cartridge component, and a disposable sample collection component. The reader component may communicate with a remote computing device for the digital transmission of test protocols and test results. In various disclosed embodiments, the systems, components, and methods are configured to identify the presence, absence, and/or quantity of particular nucleic acids, proteins, or other analytes of interest, for example, in order to test for the presence of one or more pathogens or contaminants in a sample.

Claims (41)

1. A sample analysis cartridge comprising a housing:

an input tunnel that extends from an aperture in the housing, the input tunnel configured to permit insertion of a sample collection device having a distal portion adapted to be exposed to a sample;

a reservoir configured to hold a fluid, the reservoir further configured to receive the sample collected by the sample collection device;

a collet disposed in the input tunnel between the reservoir and the aperture, the collet comprising a collet body having a collet proximal end and a collet distal end, a deflector portion, and a lumen extending between the collet proximal end and the collet distal end, the lumen sized to receive the distal portion of the sample collection device therein;

a shuttle at least partially disposed within the collet in a first position, the shuttle comprising a shuttle body having a shuttle proximal end and a shuttle distal end and defining a sample compartment between the shuttle proximal end and the shuttle distal end, the shuttle configured to receive the sample collected by the sample collection device in the sample compartment through an opening at the shuttle proximal end, the shuttle further configured to move within the input tunnel from the first position to a second position responsive to force applied on the shuttle from the sample collection device during insertion of the sample collection device in the input tunnel; and

a contact switch disposed adjacent the deflector portion of the collet,

wherein the deflector portion is configured to deflect to activate the contact switch responsive to force applied on the deflector portion by the sample collection device during insertion of the sample collection device in the input tunnel.

2. The sample analysis cartridge of claim 1 , wherein the shuttle is configured to move within the input tunnel from the first position to the second position after the collet is decoupled from the shuttle such that the shuttle is at least partially disposed within the reservoir in the second position and the sample is exposed to the fluid in the reservoir.

3. The sample analysis cartridge of claim 1 , wherein the shuttle further defines a reagent ball compartment between the shuttle proximal end and the shuttle distal end configured to house a reagent ball comprising reagents.

4. The sample analysis cartridge of claim 3 , wherein the reagent ball is disposed in the shuttle to not be exposed to the fluid in the reservoir in the first position and to be exposed to the fluid in the reservoir in the second position.

5. The sample analysis cartridge of claim 1 , wherein the shuttle proximal end is configured to be disposed within the lumen of the collet in the first position.

6. The sample analysis cartridge of claim 5 , wherein the shuttle distal end forms at least a part of a wall of the reservoir in the first position.

7. The sample analysis cartridge of claim 1 , wherein the collet comprises one or more locking arms configured to couple the collet to the shuttle in the first position.

8. The sample analysis cartridge of claim 7 , wherein the one or more locking arms are configured to be deflected to decouple the one or more locking arms from the shuttle responsive to force applied on the one or more locking arms by the sample collection device during insertion of the sample collection device in the input tunnel.

9. The sample analysis cartridge of claim 1 , further comprising a sensor configured to be exposed to the fluid mixed with the sample, the sensor further configured to generate a signal indicative of at least one of a presence, absence, or quantity of the one or more analytes within the sample.

10. The sample analysis cartridge of claim 1 , further comprising a sealing material configured to fluidicly seal the fluid within the reservoir and a seal piercer disposed partially within the input tunnel, the seal piercer configured to be contacted by the sample collection device within the input tunnel and to move, responsive to force applied by the sample collection device, to pierce the sealing material to vent the fluid in the reservoir.

11. The sample analysis cartridge of claim 10 , wherein the collet comprises a slot and a portion of the seal piercer extends through the slot into the input tunnel to permit contact between the seal piercer and the sample collection device.

12. The sample analysis cartridge of claim 1 , wherein the deflector portion of the collet comprises an arm configured to deflect downward to activate the contact switch.

13. The sample analysis cartridge of claim 1 , wherein the contact switch is positioned such that activation of the contact switch indicates full insertion of the sample collection device in the input tunnel.

14. The sample analysis cartridge of claim 1 , wherein the collet further comprises one or more protrusions configured to couple to the shuttle proximal end in the first position.

15. The sample analysis cartridge of claim 14 , wherein the one or more protrusions each comprise lead-in angles configured to guide the distal portion of the sample collection device into the opening at the shuttle proximal end.

16. A sample analysis cartridge comprising a housing:

an input tunnel that extends from an aperture in the housing, the input tunnel configured to permit insertion of a sample collection device having a distal portion adapted to be exposed to a sample;

a reservoir configured to hold a fluid, the reservoir further configured to receive the sample collected by the sample collection device;

a shuttle disposed in the input tunnel between the reservoir and the aperture in a first position, the shuttle comprising a shuttle body having a shuttle proximal end and a shuttle distal end and defining a sample compartment between the shuttle proximal end and the shuttle distal end, the shuttle configured to receive the sample collected by the sample collection device in the sample compartment through an opening at the shuttle proximal end, the shuttle further configured to move within the input tunnel from the first position to a second position responsive to force applied on the shuttle from the sample collection device during insertion of the sample collection device in the input tunnel; and

a collet disposed in the input tunnel and coupled to the shuttle in the first position such that the shuttle is at least partially disposed within the collet in the first position, the collet comprising a collet body having a collet proximal end and a collet distal end and a lumen extending between the collet proximal end and the collet distal end, the lumen sized to receive the distal portion of the sample collection device therein, the collet configured to decouple from the shuttle during insertion of the sample collection device in the input tunnel,

wherein the shuttle is configured to move within the input tunnel from the first position to the second position after the collet is decoupled from the shuttle such that the shuttle is at least partially disposed within the reservoir in the second position and the sample is exposed to the fluid in the reservoir.

17. The sample analysis cartridge of claim 16 , wherein the shuttle proximal end is configured to be disposed within the lumen of the collet in the first position.

18. The sample analysis cartridge of claim 16 , wherein the shuttle distal end forms a wall of the reservoir in the first position.

19. The sample analysis cartridge of claim 16 , wherein the collet comprises one or more locking arms configured to couple the collet to the shuttle in the first position.

20. The sample analysis cartridge of claim 19 , wherein the one or more locking arms are configured to be deflected to decouple the one or more locking arms from the shuttle responsive to force applied on the one or more locking arms by the sample collection device during insertion of the sample collection device in the input tunnel.

21. The sample analysis cartridge of claim 16 , further comprising a sealing material configured to fluidicly seal the fluid within the reservoir and a seal piercer disposed partially within the input tunnel, the seal piercer configured to be contacted by the sample collection device within the input tunnel and to move, responsive to force applied by the sample collection device, to pierce the sealing material to vent the fluid in the reservoir.

22. The sample analysis cartridge of claim 21 , wherein the collet comprises a slot and a portion of the seal piercer extends through the slot into the input tunnel to permit contact between the seal piercer and the sample collection device.

23. The sample analysis cartridge of claim 16 , further comprising a sensor configured to be exposed to the fluid mixed with the sample, the sensor further configured to generate a signal indicative of at least one of a presence, absence, or quantity of the one or more analytes within the sample.

24. The sample analysis cartridge of claim 16 , further comprising a contact switch,

wherein the collet comprises a deflector portion disposed adjacent the contact switch, the deflector portion configured to deflect to activate the contact switch responsive to force applied on the deflector portion by the sample collection device during insertion of the sample collection device in the input tunnel.

25. The sample analysis cartridge of claim 24 , wherein the deflector portion of the collet comprises an arm configured to deflect downward to activate the contact switch.

26. The sample analysis cartridge of claim 24 , wherein the contact switch is positioned such that activation of the contact switch indicates full insertion of the sample collection device in the input tunnel.

27. The sample analysis cartridge of claim 16 , wherein the collet further comprises one or more protrusions configured to couple to the shuttle proximal end in the first position, the one or more protrusions each comprising lead-in angles configured to guide the distal portion of the sample collection device into the opening at the shuttle proximal end.

28. The sample analysis cartridge of claim 16 , wherein the shuttle further defines a reagent ball compartment between the shuttle proximal end and the shuttle distal end configured to house a reagent ball comprising reagents, and

wherein the reagent ball is disposed in the shuttle to not be exposed to the fluid in the reservoir in the first position and to be exposed to the fluid in the reservoir in the second position.

Assignments (7)
ASSIGNMENT BY BANKRUPTCY Recorded Oct 4, 2024
From: CUE HEALTH INC.
To: SIRO DIAGNOSTICS, INC.
Reel/Frame 070226/0119 →
RELEASE OF SECURITY INTEREST Recorded May 17, 2024
From: EAST WEST BANK, AS COLLATERAL AGENT AND ADMINISTRATIVE AGENT
To: CUE HEALTH INC.
Reel/Frame 067456/0574 →
SECURITY AGREEMENT Recorded Jul 11, 2022
From: CUE HEALTH INC.
To: EAST WEST BANK, AS COLLATERAL AGENT AND ADMINISTRATIVE AGENT
Reel/Frame 060621/0319 →
RELEASE OF SECURITY INTEREST Recorded Jun 25, 2021
From: EAST WEST BANK
To: CUE HEALTH INC.
Reel/Frame 056668/0043 →
SECURITY INTEREST Recorded Apr 9, 2021
From: CUE HEALTH INC.
To: EAST WEST BANK, AS COLLATERAL AND ADMINISTRATIVE AGENT
Reel/Frame 055875/0575 →
MERGER AND CHANGE OF NAME Recorded May 3, 2018
From: CUE INC.; CUE HEALTH INC.
To: CUE HEALTH INC.
Reel/Frame 045711/0743 →
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Jun 20, 2017
From: KHATTAK, AYUB; SEVER, CLINTON; NELSON, PAUL; COOPER, RYAN; CONGDON, THOMAS; DEMARTINO, JUSTIN; SHAPIRO, RAPHAEL; DUNCAN, MARK
To: CUE INC.
Reel/Frame 042756/0246 →
Continuity (3)
Continuation PCTUS2016042688 · Jul 16, 2016
Provisional Application 62194101 · Jul 17, 2015
Related Publication 20170045508A1 · Feb 16, 2017