IP Library › Granted Patent US 11,253,179
Granted Patent B2
US 11,253,179 · App. 15/156,386 · Granted Feb 22, 2022

Systems and methods for collection and/or manipulation of blood spots or other bodily fluids

Inventors: Howard Bernstein (Cambridge, MA); Donald E. Chickering, III (Framingham, MA); Shawn Davis (Santa Monica, CA); Ping Gong (Belmont, MA); Kristin Horton (Brighton, MA); Scott James (Epping, NH)
Assignee: YourBio Health, Inc.
A61B5/150099A61B5/1411A61B5/1438A61B5/14514A61B5/14532A61B5/14539A61B5/14546A61B5/151A61B5/154A61B5/150022A61B5/15105A61B5/15142A61B5/150213A61B5/150221A61B5/150229A61B5/150343A61B5/150358A61B5/150412A61B5/150419A61B5/150503A61B5/150755A61B5/150969A61B5/150984A61M1/34A61M1/3486A61M1/3687B01L3/502753G01N33/1826A61B5/1455A61B5/1486A61B10/0045A61B2562/0295A61M2202/0415A61M2205/3334B01L2300/0672B01L2300/0681B01L2300/087B01L2300/0816B01L2300/0874B01L2400/049B01L2400/0655B01L2400/0688G01N33/18
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Quick Facts
Patent No.
US 11,253,179
App. No.
15/156,386
Granted
Feb 22, 2022
Kind
B2
Abstract

The present invention generally relates to systems and methods for receiving blood (or other bodily fluids) from a subject, e.g., from or beneath the skin of a subject. In some cases, the blood (or other bodily fluids) may be deposited on a membrane or other substrate. For example, blood may be absorbed in a substrate, and dried in some cases to produce a dried blood spot. In one aspect, the present invention is generally directed to devices and methods for receiving blood from a subject, e.g., from the skin, using devices including a substance transfer component (which may contain, for example, one or more microneedles), and directing the blood on a substrate, e.g., for absorbing blood. The substrate, in some embodiments, may comprise filter paper or cotton-based paper. After absorption of some blood onto the substrate, the substrate may be removed from the device and shipped or analyzed. In some cases, the device itself may be shipped or analyzed. For example, in some embodiments, a portion of the device may be sealed such that the substrate is contained within an airtight portion of the device, optionally containing desiccant. Other aspects are generally directed at other devices for receiving blood (or other bodily fluids), kits involving such devices, methods of making such devices, methods of using such devices, and the like.

Claims (30)

1. A method, comprising:

applying, to a subject having skin, a device to the skin of the subject, the device comprising a substance transfer component comprising one or more needles, a substrate comprising paper for absorbing blood, and a pressure controller able to create an internal pressure less than atmospheric pressure within a vacuum chamber within the device;

causing the device to insert the one or more needles into the skin using a deployment actuator that moves the one or more needles from a first position within the device to a second position within the device where the one or more needles are inserted into the skin, and to apply reduced pressure to the skin of the subject from the vacuum chamber, to withdraw blood from the skin of the subject into the device such that the blood contacts the substrate comprising paper and is absorbed into the paper;

moving the one or more needles from second position within the device to the first position within the device while the device is applied to the skin without using the deployment actuator;

drying the absorbed blood in the substrate to form a dried blood spot in the substrate; and

removing the substrate from the device.

2. The method of claim 1 , wherein the substrate comprises filter paper.

3. The method of claim 1 , wherein the substrate comprises cotton-based paper.

4. The method of claim 1 , wherein the substrate comprises cotton linter paper.

5. The method of claim 1 , wherein a portion of the device is sealable to create an airtight portion surrounding the substrate for absorbing blood.

6. The method of claim 5 , wherein the device comprises a movable portion that sealingly creates the airtight portion.

7. The method of claim 1 , wherein the device comprises a cover for covering at least a portion of the substance transfer component.

8. The method of claim 1 , wherein the device further comprises a tracking apparatus.

9. The method of claim 1 , wherein the substrate further comprises a stabilizer.

10. The method of claim 9 , wherein the stabilizer comprises a chelating agent.

11. The method of claim 9 , wherein the stabilizer comprises an enzyme inhibitor.

12. The method of claim 11 , wherein the stabilizer comprises a lysing agent.

13. The method of claim 9 , wherein the stabilizer is contained within the substrate for absorbing blood.

14. The method of claim 1 , wherein drying the absorbed blood in the substrate comprises exposing the substrate to an environment external to the device.

15. The method of claim 1 , wherein drying the absorbed blood in the substrate comprises exposing the substrate to an internal environment contained within the device.

16. The method of claim 15 , wherein the internal environment contained within the device comprises desiccant.

17. The method of claim 1 , wherein at least one of the one or more needles is a microneedle.

18. The method of claim 1 , further comprising shipping at least the substrate.

19. The method of claim 18 , comprising shipping at least the substrate by mail.

20. The method of claim 18 , comprising shipping at least the substrate at ambient temperature.

21. The method of claim 1 , comprising causing the device to insert the one or more needles into the skin, and to apply reduced pressure to the skin of the subject, by pressing a button on the device.

22. The method of claim 1 , wherein the deployment actuator comprises a spring.

23. The method of claim 1 , wherein the deployment actuator can only be actuated once.

24. The method of claim 1 , wherein the deployment actuator moves the one or more needles into the skin at a speed of at least about 0.1 cm/s.

25. The method of claim 1 , further comprising a microfluidic channel for flowing the blood to the substrate for absorbing blood.

Assignments (5)
PATENT SECURITY AGREEMENT Recorded Mar 24, 2026
From: YOURBIO HEALTH, INC.
To: JPMORGAN CHASE BANK, N.A., AS COLLATERAL AGENT
Reel/Frame 075179/0838 →
CHANGE OF NAME Recorded Sep 17, 2021
From: SEVENTH SENSE BIOSYSTEMS, INC.
To: YOURBIO HEALTH, INC.
Reel/Frame 057538/0050 →
RELEASE OF SECURITY INTEREST Recorded Oct 31, 2018
From: COMERICA BANK
To: SEVENTH SENSE BIOSYSTEMS, INC.
Reel/Frame 047902/0113 →
SECURITY INTEREST Recorded Feb 26, 2018
From: SEVENTH SENSE BIOSYSTEMS, INC.
To: COMERICA BANK
Reel/Frame 045446/0307 →
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded May 17, 2016
From: BERNSTEIN, HOWARD; CHICKERING, DONALD E., III; DAVIS, SHAWN; GONG, PING; HORTON, KRISTIN; JAMES, SCOTT
To: SEVENTH SENSE BIOSYSTEMS, INC.
Reel/Frame 038614/0894 →
Continuity (4)
Continuation 13456546 · Apr 26, 2012
Provisional Application 61549437 · Oct 20, 2011
Provisional Application 61480941 · Apr 29, 2011
Related Publication 20170127991A1 · May 11, 2017
Cited By (4)
US 12,214,346 US 12,440,133 US 12,446,810 US 12,672,806