IP Library Granted Patent US 11,266,337
Granted Patent B2
US 11,266,337 · App. 15/261,707 · Granted Mar 8, 2022

Systems, methods, and devices for sample collection, stabilization and preservation

Inventors: Alicia Jackson (Menlo Park, CA); Rowan Chapman (Menlo Park, CA); Diana Maichin (San Francisco, CA); Harry Glorikian (Lexington, MA)
Assignee: DRAWBRIDGE HEALTH, INC.
A61B5/150984A61B5/150022A61B5/150083A61B5/15113A61B5/15142A61B5/15144A61B5/150358A61B5/150389A61B5/150412A61B5/150503A61B5/150755A61B5/150786A61B5/150793
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Quick Facts
Patent No.
US 11,266,337
App. No.
15/261,707
Granted
Mar 8, 2022
Kind
B2
Abstract

Herein, systems and methods are disclosed including a sample acquisition component (SAC) for user-friendly sample collection, a separation component for optional separation of plasma, and one or more stabilization components for stabilizing analytes. In a particular embodiment, the system and methods are directed towards sample collection and stabilization with optional sample separation. Other embodiments can perform any combination of collection, separation, stabilization or detection.

Claims (26)

1. A method for collecting a bio-sample from a subject, the method comprising

obtaining an integrated sample acquisition and sample stabilization device comprising: (i) a sample acquisition component, wherein the sample acquisition component comprises piercing elements; and (ii) more than one paper stabilization matrix, wherein the more than one paper stabilization matrices are stacked and do not contact each other; wherein the more than one paper stabilization matrices are separated by one or more solid supports wherein the one or more solid supports do not comprise filters;

applying the device to a skin of the subject;

actuating the sample acquisition component causing the piercing elements to puncture the skin of the subject;

withdrawing the piercing elements under vacuum, causing the bio-sample to enter an opening in the sample acquisition component; and

moving the bio-sample from the opening in the sample acquisition component through a channel onto the more than one paper stabilization matrices that are stacked and do not contact each other, wherein the bio-sample is collected on the more than one paper stabilization matrices, wherein during the moving, the more than one paper stabilization matrices are stacked and do not contact each other,

wherein the moving the bio-sample from the opening in the sample acquisition component through the channel onto the more than one paper stabilization matrices that are stacked and do not contact each other occurs by vacuum.

2. The method of claim 1 , wherein the moving the bio-sample comprises moving more than 100 μl of the bio-sample.

3. The method of claim 2 , wherein the bio-sample comprises a volume of under 500 μL.

4. The method of claim 1 , wherein the more than one paper stabilization matrices are porous matrices comprising cellulose, cellulose acetate, glass fiber, or a combination thereof.

5. The method of claim 1 , further comprising removing from the integrated sample acquisition and sample stabilization device the more than one paper stabilization matrices comprising the collected bio-sample.

6. The method of claim 1 , wherein the bio-sample is blood.

7. The method of claim 6 , further comprising inducing blood flow in the subject prior to piercing the subject with the piercing elements.

8. The method of claim 1 , wherein each matrix of the more than one paper stabilization matrices comprises a same composition.

9. The method of claim 1 , wherein the channel is one channel.

10. The method of claim 1 , wherein the more than one paper stabilization matrices are two paper stabilization matrices.

11. The method of claim 1 , wherein one or more stabilizing reagents are disposed on or integrated with the more than one paper stabilization matrices, and the more than one paper stabilization matrices are in a substantially dry state of less than 10% by weight hydration.

12. The method of claim 1 , wherein the more than one paper stabilization matrices are configured to substantially stabilize RNA for at least 11 days at 37 degrees Celsius.

13. The method of claim 1 , further comprising removing from the integrated sample acquisition and sample stabilization device the more than one paper stabilization matrices comprising the collected bio-sample.

14. The method of claim 1 , further comprising performing an assay on the collected bio-sample.

15. The method of claim 1 , wherein the more than one paper stabilization matrices comprising the collected bio-sample are stored for at least one week.

16. The method of claim 1 , wherein the more than one paper stabilization matrices are substantially dry with a water content of less than 2%.

17. The method of claim 1 , further comprising eluting the collected bio-sample from the more than one paper stabilization matrices.

18. The method of claim 1 , wherein moving the bio-sample from an opening in the sample acquisition component through the channel onto the more than one paper stabilization matrices also occurs by spontaneous capillary flow, wicking through absorbent materials, or a combination thereof.

19. The method of claim 1 , further comprising inducing blood flow in the subject prior to piercing the subject with the piercing elements.

20. The method of claim 1 , wherein the piercing elements are connected to a spring.

Assignments (4)
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Mar 8, 2018
From: GENERAL ELECTRIC COMPANY
To: DRAWBRIDGE HEALTH, INC.
Reel/Frame 045529/0063 →
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Jul 25, 2017
From: CHAPMAN, ROWAN
To: GENERAL ELECTRIC COMPANY
Reel/Frame 043328/0347 →
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Feb 23, 2017
From: GLORIKIAN, HARRY; MAICHIN, DIANA
To: GENERAL ELECTRIC COMPANY
Reel/Frame 041791/0729 →
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Jan 6, 2017
From: JACKSON, ALICIA
To: DRAWBRIDGE HEALTH, INC.
Reel/Frame 040877/0689 →
Continuity (5)
Provisional Application 62216312 · Sep 9, 2015
Provisional Application 62260172 · Nov 25, 2015
Provisional Application 62367056 · Jul 26, 2016
Provisional Application 62368817 · Jul 29, 2016
Related Publication 20170067803A1 · Mar 9, 2017
Cited By (3)
US 12,214,346 US 12,440,133 US 12,446,810