Cartridge assemblies for storing biological samples

• US 10,888,259 B2
• Filed: 11/15/2019
• Issued: 01/12/2021
• Est. Priority Date: 01/10/2017
• Status: Active Grant

• Current Assignee: Drawbridge Health, Inc. (Thorne HealthTech, Inc.)
• Original Assignee: Drawbridge Health, Inc. (Thorne HealthTech, Inc.)
• Inventors: Jordan, Brett L., Drexel, Masao, Beyerlein, Dagmar, Jackson, Alicia, Juneau, Kara
• Primary Examiner(s): White, Dennis
• Application Number:
  US16/685,999
• Publication Number:
  US 20200164359A1
• Time in Patent Office: 424 Days
• CPC Class Codes: A61B 5/150022 for capillary blood or interstitial fluid
• CPC Class Codes: A61B 5/150099 by negative pressure, other than vacuum extraction into a syringe by pulling on the piston rod or into pre-evacuated tubes
• CPC Class Codes: A61B 5/15016 by accessories for bringing the piercing element into the body, e.g. through rotation of the piercing element
• CPC Class Codes: A61B 5/150236 Pistons, i.e. cylindrical bodies that sit inside the syringe barrel, typically with an air tight seal, and slide in the barrel to create a vacuum or to expel blood
• CPC Class Codes: A61B 5/150244 Rods for actuating or driving the piston, i.e. the cylindrical body that sits inside the syringe barrel, typically with an air tight seal, and slides in the barrel to create a vacuum or to expel blood
• CPC Class Codes: A61B 5/150251 Collection chamber divided into at least two compartments, e.g. for division of samples injection syringes having more than one chamber A61M5/19; syringes for injection of two or more media A61M5/2448, A61M5/284; sample preparation for further analysis A61B5/150755
• CPC Class Codes: A61B 5/150305 Packages specially adapted for piercing devices or blood sampling devices kits for diabetes A61M5/003; packaging in general B65D
• CPC Class Codes: A61B 5/150343 Collection vessels for collecting blood samples from the skin surface, e.g. test tubes, cuvettes sampling from within body cavities A61B5/150015, A61B5/150045
• CPC Class Codes: A61B 5/150427 Specific tip design, e.g. for improved penetration characteristics
• CPC Class Codes: A61B 5/150442 Blade-like piercing elements, e.g. blades, cutters, knives, for cutting the skin
• CPC Class Codes: A61B 5/150503 Single-ended needles hollow piercing element tip design A61B5/150396, needle sets for catheters A61M25/06, needles for bringing media into the body A61M5/32
• CPC Class Codes: A61B 5/150969 Low-profile devices which resemble patches or plasters, e.g. also allowing collection of blood samples for testing
• CPC Class Codes: A61B 5/150977 Arrays of piercing elements for simultaneous piercing
• CPC Class Codes: A61B 5/150984 Microneedles or microblades
• CPC Class Codes: A61B 5/15113 Manually triggered, i.e. the triggering requires a deliberate action by the user such as pressing a drive button
• CPC Class Codes: A61B 5/15117 comprising biased elements, resilient elements or a spring, e.g. a helical spring, leaf spring, or elastic strap
• CPC Class Codes: A61B 5/1513 comprising linear sliding guides comprising tooth-shaped elements A61B5/15132
• CPC Class Codes: A61B 5/15142 Devices intended for single use, i.e. disposable
• CPC Class Codes: B01L 2200/026 Fluid interfacing between devices or objects, e.g. connectors, inlet details
• CPC Class Codes: B01L 2200/18 Transport of container or devices
• CPC Class Codes: B01L 2300/021 : Identification, e.g. bar codes
• CPC Class Codes: B01L 2300/041 : Connecting closures to device or container
• CPC Class Codes: B01L 2300/06 : Auxiliary integrated devices, integrated components
• CPC Class Codes: B01L 2300/0609 : Holders integrated in container to position an object
• CPC Class Codes: B01L 2300/0825 : Test strips
• CPC Class Codes: B01L 2300/0864 : comprising only one inlet and multiple receiving wells, e.g. for separation, splitting
• CPC Class Codes: B01L 2400/0406 : capillary forces
• CPC Class Codes: B01L 2400/049 : vacuum
• CPC Class Codes: B01L 3/0296 : from piercable tubing, e.g. in extracorporeal blood sampling
• CPC Class Codes: B01L 3/5023 : with a sample being transported to, and subsequently stored in an absorbent for analysis
• CPC Class Codes: B01L 3/508 : rigid containers not provided for above
• CPC Class Codes: G01N 33/487 : of liquid biological material
• CPC Class Codes: G01N 33/54386 : Analytical elements
• CPC Class Codes: G01N 35/00732 : Identification of carriers, materials or components in automatic analysers

Abstract

Disclosed herein are devices, apparatus, systems, methods and kits for collecting and storing a fluid sample from a subject. A device for collecting the fluid sample can include a housing comprising a recess having an opening, a vacuum chamber in the housing and in fluidic communication with the recess, and one or more piercing elements that are extendable through the opening to penetrate skin of the subject. The vacuum chamber can be configured for having a vacuum that draws the skin into the recess. The recess can be configured having a size or shape that enables an increased volume of the fluid sample to be accumulated in the skin drawn into the recess.

Claims

1. A cartridge assembly comprising:

a cartridge comprising a port that is configured to receive a blood sample of a subject from a blood collection device, the cartridge supporting one or more porous matrices for storing and stabilizing the blood sample; and

a cartridge holder configured to releasably couple to and support the cartridge,

wherein the cartridge assembly is configured to releasably couple to a deposition chamber of the blood collection device.

2. The cartridge assembly of claim 1, wherein the port is configured to releasably couple to and establish fluidic communication with a channel of the blood collection device.

3. The cartridge assembly of claim 2, wherein the blood sample is collected from penetrated skin of the subject using the blood collection device and transported through the channel into the cartridge via the port.

4. The cartridge assembly of claim 1, wherein the cartridge holder is configured to releasably couple to the cartridge via a quick release mechanism.

5. The cartridge assembly of claim 4, wherein the quick release mechanism comprises one or more spring-clips on the cartridge holder.

6. The cartridge assembly of claim 1, wherein the cartridge assembly is configured to be releasably coupled and decoupled from the deposition chamber without use of tools.

7. The cartridge assembly of claim 1, wherein the cartridge assembly is configured to be releasably coupled and decoupled from the deposition chamber using no more than two motion steps.

8. The cartridge assembly of claim 2, wherein the port comprises a luer-type fitting that is configured to mechanically engage with an opening to the channel of the blood collection device.

9. The cartridge assembly of claim 1, wherein the cartridge assembly is configured to be releasably coupled to the deposition chamber prior to use of the blood collection device to collect the blood sample from the subject.

10. The cartridge assembly of claim 1, wherein the cartridge assembly is configured to be released and decoupled from the deposition chamber after the blood sample has been collected from the subject and stored on the one or more porous matrices.

11. The cartridge assembly of claim 1, further comprising two or more porous matrices for storing and stabilizing the blood sample.

12. The cartridge assembly of claim 11, wherein the cartridge is configured to support the two or more porous matrices in a configuration that permits the blood sample to wick between and along the two or more porous matrices.

13. The cartridge assembly of claim 12, wherein the configuration permits the blood sample to be transported along a flow path from a proximal end to a distal end of the two or more porous matrices via wicking action or capillarity, or aided by gravity.

14. The cartridge assembly of claim 13, wherein the proximal end of the two or more porous matrices is located closer to the port of the cartridge than the distal end of the two or more porous matrices.

15. The cartridge assembly of claim 12, wherein the two or more porous matrices are disposed substantially parallel to each other.

16. The cartridge assembly of claim 12, wherein the two or more porous matrices are separated apart from each other using one or more spacers.

17. The cartridge assembly of claim 15, wherein the two or more porous matrices are separated apart by a gap of about 0.5 mm.

18. The cartridge assembly of claim 16, wherein two or more of the spacers are placed between the two or more porous matrices to form a flow channel through which the blood sample is transported.

19. The cartridge assembly of claim 1, wherein at least one of the porous matrices is configured to store at least 50 μ

L of the blood sample.

20. The cartridge assembly of claim 11, wherein each of the two or more porous matrices is configured to store at least 50 μ

L of the blood sample.

21. The cartridge assembly of claim 1, further comprising:

one or more absorbent pads placed in fluidic communication with the one or more porous matrices, wherein the one or more absorbent pads are configured to hold an excess amount of the blood sample.

22. The cartridge assembly of claim 21, wherein the one or more absorbent pads aid in ensuring that a predefined volume of the blood sample is collected and stored on the one or more porous matrices.

23. The cartridge assembly of claim 21, wherein the cartridge holder comprises a slot for supporting the one or more absorbent pads.

24. The cartridge assembly of claim 21, wherein the one or more absorbent pads are in contact with a distal end of the one or more porous matrices, wherein the distal end is located further away from the port of the cartridge than a proximal end of the one or more porous matrices.

25. The cartridge assembly of claim 21, wherein the excess amount of the blood sample is at least 10 μ

L.

26. The cartridge assembly of claim 22, wherein the predefined volume of the blood sample is at least 100 μ

L.

27. The cartridge assembly of claim 1, wherein the cartridge holder comprises a cartridge tab that is configured to be releasably coupled to a distal end of the deposition chamber.

28. The cartridge assembly of claim 27, wherein the cartridge tab is configured to serve as a handle to the subject or a user for holding the cartridge assembly.

29. The cartridge assembly of claim 27, wherein the cartridge tab is configured to be pressed against the distal end of the deposition chamber in a first direction in order to couple the cartridge assembly to the blood collection device.

30. The cartridge assembly of claim 29, wherein the cartridge tab is configured to be pulled from the deposition chamber in a second direction to decouple the cartridge assembly from the blood collection device after the blood sample has been collected and stored on the one or more porous matrices, and wherein the first direction and the second direction are substantially opposite to each other.

31. The cartridge assembly of claim 1, wherein the one or more porous matrices are absorbent.

32. The cartridge assembly of claim 1, wherein the one or more porous matrices comprise paper.

33. The cartridge assembly of claim 32, wherein the paper comprises cellulose.