IP Library Granted Patent US 12,004,726
Granted Patent B2
US 12,004,726 · App. 17/243,244 · Granted Jun 11, 2024

Sample collection device

Inventors: Graham P. Lidgard (Madison, WI); Michael J. Domanico (Middleton, WI); Keith Fourrier (Madison, WI); James P. Light, II (Middleton, WI); Scott Castanon (Carlsbad, CA); Keith Kopitzke (Fallbrook, CA)
Assignee: Exact Sciences Corporation
A61B10/0038G01N1/38B01L3/50825
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Quick Facts
Patent No.
US 12,004,726
App. No.
17/243,244
Granted
Jun 11, 2024
Kind
B2
Abstract

Provided herein is technology relating to collecting and preparing samples. For example, the technology relates particularly, but not exclusively, to devices, systems, and kits that allow a subject to collect and prepare a sample for analysis.

Claims (35)

1. A collection device containing a metered stool sample, the device comprising:

a) a body comprising a sample collection chamber bounded on a distal end by a penetrable seal and bounded on a proximal end by a septum comprising an aperture, the penetrable seal being penetrable by a pipette tip or needle;

b) a flexible sampling rod comprising a proximal portion and a distal portion, the sampling rod adapted to fit through and seal the aperture when the distal portion is in the sample collection chamber, wherein the distal portion comprises:

i) an asymmetrical beveled tip at a distal end, the beveled tip having an apex at the circumference of the flexible sampling rod and configured to bend the flexible sampling rod away from collisions and/or to deflect collisions with an inserted pipette tip or needle; and

ii) one or a plurality of metering ridges;

wherein the sampling rod is positioned through the aperture in the septum such that the aperture in the septum is sealed by the sampling rod, and wherein the distal end of the sampling rod and a metered sample of stool are present in the sample collection chamber.

2. The device of claim 1 , wherein the collection device comprises a solution in the sample collection chamber for preserving the metered sample of the stool.

3. The device of claim 2 , wherein the metered sample and the solution form a suspension.

4. The device of claim 2 , wherein the solution has a volume of 2 milliliters.

5. The device of claim 2 , wherein the solution comprises Tris buffer, bovine serum albumin, polysorbate 20 , sodium azide, sodium chloride, ethylenediaminetetraacetic acid, and gentamicin.

6. The device of claim 1 , wherein the metered sample of stool is retained in the one or plurality of metering ridges.

7. The device of claim 1 wherein the sample collection chamber has a volume of 1-5 milliliters.

8. The device of claim 1 , wherein the metered sample of stool is 20 milligrams of stool.

9. The device of claim 1 , wherein a cap is attached to the proximal end of the sampling rod, wherein the cap engages a proximal end of the body of the collection device.

10. The device of claim 9 , wherein the cap and the proximal end of the body have mated threads that engage with each other to secure the cap to the proximal end of the body of the collection device.

11. The device of claim 1 , wherein the composition of the penetrable seal comprises one or more of:

a) a foil;

b) a foil layer and a polyester layer; and

c) a material selected from the group consisting of paper, rubber, wax, and plastic.

12. The device of claim 1 , wherein the penetrable seal is configured to hold 30 psi when the device is internally pressurized with air.

13. The device of claim 1 , wherein the body further comprises a sealing surface, wherein the penetrable seal is affixed to the sealing surface.

14. The device of claim 13 , wherein the sealing surface is recessed.

15. The device of claim 1 , further comprising a protective cap fitted on a distal end of the body and covering the penetrable seal.

16. The device of claim 1 , wherein the body is made from a material selected from the group consisting of polypropylene, polyethylene, polystyrene, and polytetrafluoroethylene.

17. The device of claim 1 , wherein the collection device is enclosed in a package for mailing the device containing the metered sample of stool.

18. A system comprising:

I) a collection device containing a metered stool sample, the device comprising:

a) a body comprising a sample collection chamber bounded on a distal end by a penetrable seal and bounded on a proximal end by a septum comprising an aperture, the penetrable seal being penetrable by a pipette tip or needle;

b) a flexible sampling rod comprising a proximal portion and a distal portion, the sampling rod adapted to fit through and seal the aperture when the distal portion is in the sample collection chamber, wherein the distal portion comprises:

i) an asymmetrical beveled tip at a distal end, the beveled tip having an apex at the circumference of the flexible sampling rod and configured to bend the flexible sampling rod away from collisions and/or to deflect collisions with an inserted pipette tip or needle; and

ii) one or a plurality of metering ridges;

c) a solution in the sample collection chamber for preserving the metered sample of the stool;

wherein the sampling rod is positioned through the aperture in the septum such that the aperture in the septum is sealed by the sampling rod, and wherein the distal end of the sampling rod and a metered sample of stool are present in the sample collection chamber;

and

II) an implement for withdrawing liquid from the sample collection chamber, the implement comprising a needle or pipette tip.

Assignments (2)
PATENT SECURITY AGREEMENT Recorded Jan 14, 2025
From: EXACT SCIENCES CORPORATION
To: JPMORGAN CHASE BANK, N.A.
Reel/Frame 069898/0249 →
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded May 14, 2021
From: LIDGARD, GRAHAM P; DOMANICO, MICHAEL J; FOURRIER, KEITH; LIGHT, JAMES P, II; CASTANON, SCOTT; KOPITZKE, KEITH
To: EXACT SCIENCES CORPORATION
Reel/Frame 056248/0517 →