IP Library Granted Patent US 11,772,097
Granted Patent B2
US 11,772,097 · App. 16/657,041 · Granted Oct 3, 2023

Simultaneous spot test and storage of blood samples

Inventor: Brandon T. Johnson (Cambridge, MA)
Assignee: RENEGADEXBIO, PBC
B01L3/502792B01L3/022B01L3/50857G01N33/566B01L2300/0825B01L2300/0829B01L2300/0832
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Quick Facts
Patent No.
US 11,772,097
App. No.
16/657,041
Granted
Oct 3, 2023
Kind
B2
Abstract

A blood sample collection and/or storage device includes a two-piece housing that encompasses a port at which a fingertip blood sample is collected. After the sample is taken, the two-piece housing is moved to a closed position to protect the sample for storage and optionally process the sample within the housing. The housing may also be opened to access the stored sample for further processing.

Claims (43)

1. A biological fluid sample collection device comprising:

a housing comprising a first housing section and a second housing section, the housing configurable from a first position to a second position by moving the first housing section and the second housing section together, the housing enclosing:

a sample collection well;

a capillary in fluid communication with the sample collection well, wherein the capillary is configured to hold a predetermined volume of a sample comprising one or more analytes;

a medium in fluid communication with the capillary, wherein the medium is configured to retain at least a portion of the sample or a derivative thereof, wherein the medium comprises a conjugate configured to bind the one or more analytes to perform a test, wherein the medium comprises an immunoassay strip comprising the conjugate configured to bind the one or more analytes;

a reagent configured to be dispensed onto the medium when the housing is moved from the first position to the second position;

a mechanically actuated fluid controller, configured to cause a predetermined volume of the sample to be dispensed from the capillary onto the medium when the housing is moved from the first position to the second position,

wherein the reagent and the sample are mixed when dispensed onto the medium when the housing is moved from the first position to the second position to initiate performance of the test, and

wherein, when the housing is in the first position, the sample collection well is positioned on an exterior surface of the housing and is configured to receive the sample from a user and when the housing is in the second position, the sample collection well is fully enclosed within the housing and is inaccessible to the user.

2. The device of claim 1 further comprising:

a support element disposed within the housing and providing support for the medium.

3. The device of claim 1 wherein the mechanically actuated fluid controller comprises:

a plunger, disposed in line with the capillary and configured to dispense fluid from the capillary onto the medium.

4. The device of claim 1 wherein the medium comprises one or more of a paper, fiber, plastic, glass or microfluidic detector.

5. The device of claim 1 , wherein the mechanically actuated fluid controller is configured to dispense the predetermined volume of the sample from the capillary onto the medium and the reagent onto the medium in parallel, when the housing is moved from the first position to the second position.

6. The device of claim 1 , wherein the housing further comprises a desiccant.

7. A method of performing an assay on a blood sample comprising:

providing a blood sample comprising one or more analytes;

providing a blood sample collection device comprising:

a housing comprising a first housing section and a second housing section, the housing configurable from a first position to a second position by moving the first housing section and the second housing section together, the housing enclosing:

a sample collection well;

a capillary in fluid communication with the sample collection well,

wherein the capillary is configured to hold a predetermined volume of the blood sample

a medium in fluid communication with the capillary, wherein the medium is configured to retain at least a portion of the blood sample or a derivative thereof, wherein the medium comprises a conjugate configured to bind the one or more analytes to perform a test;

a reagent configured to be dispensed onto the medium when the housing is moved from the first position to the second position;

a mechanically actuated fluid controller, configured to dispense a predetermined volume of the blood sample or a derivative thereof from the capillary onto the medium when the housing is moved from the first position to the second position,

wherein the reagent and the sample are dispensed onto the medium when the housing is moved from the first position to the second position to initiate performance of the test, and

wherein when the housing is in the first position, the sample collection well is positioned on an exterior surface of the housing and is configured to receive the sample from a user, and when the housing is in the second position, the sample collection well is fully enclosed within the housing and is inaccessible to the user;

drawing a portion of the blood sample from the sample collection well into the capillary;

moving the housing from the first position to the second position by pushing the first housing section and the second housing section together, thereby actuating the mechanically actuated fluid controller, dispensing the sample and the reagent onto the medium, and rendering the sample collection well inaccessible to the user;

performing an assay on at least a portion of the blood sample dispensed onto the medium with the conjugate configured to bind the one or more analytes; and

indicating the result of the assay on at least a portion of the medium.

8. The method of claim 7 wherein the conjugate configured to bind the one or more analytes is comprised by an immunoassay strip.

9. The method of claim 7 wherein the conjugate configured to bind the one or more analytes is configured to allow for detection of the one or more analytes by (i) modifying an optical property of the medium to make the conjugate detectable by visual inspection, or (ii) modifying an electrical property of the medium to make the conjugate detectable by an electronic circuit.

10. The method of claim 9 further comprising:

providing immediate results of the assay by (i) inducing a color change on the medium, or (ii) inducing an electronic sensor output.

11. The method of claim 7 , wherein the device further comprises:

a support element within the housing providing support for the medium.

12. The method of claim 11 , wherein the mechanically actuated fluid controller comprises a plunger disposed in line with the capillary, the method further comprising:

operating the plunger, disposed in line with the capillary, to dispense fluid from the capillary onto the medium.

13. The method of claim 7 wherein the medium comprises one or more of a paper, fiber, plastic, glass or microfluidic detector.

14. The method of claim 7 , wherein performing the assay further comprises the conjugate configured to bind the one or more analytes binding the one or more analytes, thereby modifying the optical properties of the medium and indicating detection of the one or more analytes via a color change in the medium.

15. The method of claim 7 , wherein actuating the mechanically actuated fluid controller by moving the housing from the first position to the second position further comprises dispensing the reagent onto the medium in parallel with dispensing the predetermined volume of the blood sample from the capillary onto the medium.

Assignments (5)
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Mar 20, 2025
From: RENEGADEXBIO, PBC
To: NIGHTINGALE HEALTH OYJ
Reel/Frame 070566/0675 →
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Jul 21, 2023
From: WEAVR HEALTH CORP.
To: ANZU RENEGADE LLC
Reel/Frame 064339/0899 →
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Jul 21, 2023
From: ANZU RENEGADE LLC
To: RENEGADEXBIO, PBC
Reel/Frame 064340/0357 →
CHANGE OF NAME Recorded Jun 14, 2022
From: BOSTON MICROFLUIDICS, INC.
To: WEAVR HEALTH CORP.
Reel/Frame 060380/0644 →
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Oct 20, 2019
From: JOHNSON, BRANDON T
To: BOSTON MICROFLUIDICS, INC.
Reel/Frame 050768/0671 →
Continuity (3)
Continuation In Part 16164988 · Oct 19, 2018
Provisional Application 62772135 · Nov 28, 2018
Related Publication 20200206743A1 · Jul 2, 2020
Cited By (1)
US 1,069,617