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

• US 9,999,889 B2
• Filed: 10/27/2016
• Issued: 06/19/2018
• Est. Priority Date: 07/17/2015
• Status: Active Grant

• Current Assignee: Cue Health Inc.
• Original Assignee: Cue Health Inc.
• Inventors: Khattak, Ayub, Sever, Clinton, Nelson, Paul, Cooper, Ryan, Congdon, Thomas, Demartino, Justin, Shapiro, Raphael, Duncan, Mark
• Primary Examiner(s): Siefke, Samuel P
• Application Number:
  US15/336,739
• Publication Number:
  US 20170045508A1
• Time in Patent Office: 600 Days
• CPC Class Codes: A61B 10/0045 Devices for taking samples of body liquids devices for taking blood samples A61B5/15
• CPC Class Codes: A61B 10/02 Instruments for taking cell samples or for biopsy A61B10/0038 and A61B10/0045 take precedence; needle locating or guiding means A61B17/3403; samplers for enzymology or microbiology C12M1/26; sampling or preparing biological specimens G01N33/48
• CPC Class Codes: A61B 5/157 Devices characterised by integrated means for measuring characteristics of blood
• CPC Class Codes: B01L 2200/025 Align devices or objects to ensure defined positions relative to each other
• CPC Class Codes: B01L 2200/027 for microfluidic devices
• CPC Class Codes: B01L 2200/0668 Trapping microscopic beads
• CPC Class Codes: B01L 2200/0684 Venting, avoiding backpressure, avoid gas bubbles
• CPC Class Codes: B01L 2200/0689 Sealing
• CPC Class Codes: B01L 2200/10 Integrating sample preparation and analysis in single entity, e.g. lab-on-a-chip concept
• CPC Class Codes: B01L 2200/14 Process control and prevention of errors
• CPC Class Codes: B01L 2200/16 Reagents, handling or storing thereof
• CPC Class Codes: B01L 2300/023 Sending and receiving of information, e.g. using bluetooth
• CPC Class Codes: B01L 2300/044 pierceable, e.g. films, membranes
• CPC Class Codes: B01L 2300/047 Additional chamber, reservoir
• CPC Class Codes: B01L 2300/0627 Sensor or part of a sensor is integrated
• CPC Class Codes: B01L 2300/0645 Electrodes
• CPC Class Codes: B01L 2300/0663 Whole sensors
• CPC Class Codes: B01L 2300/0672 Integrated piercing tool
• CPC Class Codes: B01L 2300/069 Absorbents; Gels to retain a fluid
• CPC Class Codes: B01L 2300/0809 rectangular shaped
• CPC Class Codes: B01L 2300/0816 : Cards, e.g. flat sample carriers usually with flow in two horizontal directions
• CPC Class Codes: B01L 2300/0867 : Multiple inlets and one sample wells, e.g. mixing, dilution
• CPC Class Codes: B01L 2300/087 : Multiple sequential chambers
• CPC Class Codes: B01L 2300/1805 : Conductive heating, heat from thermostatted solids is conducted to receptacles, e.g. heating plates, blocks
• CPC Class Codes: B01L 2300/1827 : using resistive heater
• CPC Class Codes: B01L 2400/0406 : capillary forces
• CPC Class Codes: B01L 2400/0481 : squeezing of channels or chambers
• CPC Class Codes: B01L 2400/0677 : phase change valves; Meltable, freezing, dissolvable plugs; Destructible barriers
• CPC Class Codes: B01L 3/5023 : with a sample being transported to, and subsequently stored in an absorbent for analysis
• CPC Class Codes: B01L 3/5027 : by integrated microfluidic structures, i.e. dimensions of channels and chambers are such that surface tension forces are important, e.g. lab-on-a-chip B01L3/5023 takes precedence; micromixers B01F33/30; microreactors for synthesis B01J19/0093; microcapillary devices in general B81B1/00
• CPC Class Codes: B01L 3/502715 : characterised by interfacing components, e.g. fluidic, electrical, optical or mechanical interfaces
• CPC Class Codes: B01L 3/502738 : characterised by integrated valves microvalves F16K99/0001
• CPC Class Codes: B01L 3/5029 : using swabs
• CPC Class Codes: B01L 3/508 : rigid containers not provided for above
• CPC Class Codes: B01L 3/523 : with means for closing or opening
• CPC Class Codes: B01L 3/527 : for a plurality of reagents
• CPC Class Codes: B65D 83/005 : the piston or movable bottom being pulled upwards to dispense the contents
• CPC Class Codes: B65D 83/04 : for dispensing annular, disc-shaped, or spherical or like small articles, e.g. tablets or pills
• CPC Class Codes: B65D 83/0817 : the articles being automatically urged towards the dispensing aperture, e.g. spring-loaded B65D83/0823 takes precedence
• CPC Class Codes: B65D 83/0858 : the articles being automatically urged towards the dispensing aperture, e.g. spring-loaded B65D83/0864 takes precedence
• CPC Class Codes: C12Q 1/6825 : Nucleic acid detection involving sensors
• CPC Class Codes: G01N 27/3273 : Devices therefor, e.g. test element readers, circuitry details not specific to biochemical electrodes G01N33/4875
• CPC Class Codes: G01N 33/54366 : Apparatus specially adapted for solid-phase testing
• CPC Class Codes: G01N 35/0098 : involving analyte bound to insoluble magnetic carrier, e.g. using magnetic separation magnetic particles used in immunoassays G01N33/54326; magnetic separation in general B03C
• CPC Class Codes: G01N 35/10 : Devices for transferring samples or any liquids to, in, or from, the analysis apparatus, e.g. suction devices, injection devices G01N35/0099 takes precedence

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

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.