IP Library Granted Patent US 11,020,096
Granted Patent B2
US 11,020,096 · App. 16/888,359 · Granted Jun 1, 2021

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 11,020,096
App. No.
16/888,359
Granted
Jun 1, 2021
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 (32)

1. A method of collecting a metered sample of stool, the method comprising:

I) providing a collection 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;

II) contacting stool with the distal portion of the sampling rod to cover one or more of the one or a plurality of metering ridges with the stool;

III) inserting the distal end of the sampling rod through the aperture in the septum, such that the aperture in the septum is sealed by the sampling rod and a metered sample of the stool has entered the sample collection chamber.

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

4. The method of claim 1 , wherein a cap is attached to the proximal end of the sampling rod, wherein the cap is configured to engage a proximal end of the body of the collection device, the method further comprising after step III):

IV) engaging the cap with the proximal end of the body.

5. The method of claim 4 , 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.

6. A method of collecting a metered sample of stool from a subject, the method comprising:

I) providing to the subject a collection 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 of the sampling rod 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;

and wherein the proximal portion of the sampling rod is attached at a proximal end to a cap wherein, when the sampling rod is fitted through and sealing the aperture with the distal portion of the sampling rod in the sample collection chamber, the cap engages with a proximal end of the body to form a sealed collection device;

and

II) receiving from the subject the sealed collection device containing a metered sample of stool in the sample collection chamber.

7. The method of claim 6 , 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.

8. The method of claim 6 , wherein the collection device comprises a solution in the sample collection chamber for preserving the metered sample of the stool.

9. The method of claim 8 , wherein the solution comprises Tris buffer, bovine serum albumen, polysorbate 20, sodium azide, sodium chloride, ethylenediaminetetraacetic acid, and gentamicin.

10. The method of claim 8 , wherein the metered sample and the solution form a suspension, and wherein the method comprises a step of withdrawing at least a portion of the suspension from the sealed collection device.

11. The method of claim 10 , wherein withdrawing the suspension comprises penetrating the penetrable seal.

12. The method of claim 11 , wherein the penetrable seal is penetrated with a pipette tip or needle.

13. The method of claim 6 , further comprising providing to the subject packaging for transporting the sealed collection device, and wherein the receiving comprises receiving the packaging containing the sealed collection device containing a metered sample of the stool in the sample collection chamber.

14. The method of claim 6 , wherein providing to the subject the collection device further comprises providing an instruction for collecting the metered sample of stool using a method comprising:

I) contacting the stool with the distal portion of the sampling rod to cover one or more of the one or a plurality of metering ridges with the stool;

II) inserting the distal end of the sampling rod through the aperture in the septum, such that the aperture in the septum is sealed by the sampling rod and the metered sample of the stool has entered the sample collection chamber.

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 Jun 26, 2020
From: LIDGARD, GRAHAM P.; DOMANICO, MICHAEL J.; FOURRIER, KEITH; LIGHT, JAMES P., II; CASTANON, SCOTT; KOPITZKE, KEITH
To: EXACT SCIENCES CORPORATION
Reel/Frame 053047/0661 →