IP Library Granted Patent US 10,894,256
Granted Patent B2
US 10,894,256 · App. 16/276,185 · Granted Jan 19, 2021

Ergonomic stool specimen container and enclosing holder systems, methods, and kits

Inventors: Joseph E. Schiestle (Madison, WI); Krystal A. Burger (Lake St. Croix Beach, MN); Timothy A. Parmer (St. Paul, MN); Jad A. Lunde (Bay City, WI); Sam M. Jang (Woodbury, MN); David A. Schuelke (Hudson, WI); David B. Wolgemuth (Elk Mound, WI); Jing Yang Lu (Madison, WI)
Assignee: EXACT SCIENCES CORPORATION
B01L3/508B01L3/50825G01N1/38A61B10/0038A61B10/0096B01L2200/0689B01L2200/087B01L2200/185B01L2300/042B01L2300/043B01L2300/0832B01L2300/0858B01L2300/12G01N2001/386
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Quick Facts
Patent No.
US 10,894,256
App. No.
16/276,185
Granted
Jan 19, 2021
Kind
B2
Abstract

Provided herein is technology relating to collecting and containing samples and particularly, but not exclusively, to technology for collecting and containing a stool specimen. The technology provides a device for collecting and containing a stool specimen, the device comprising ergonomic features optimized for a geriatric user. The technology also provides an enclosing holder for securing the ergonomic stool specimen container in a leak-proof manner e.g., during mechanical shaking.

Claims (62)

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

i) depositing a stool sample in a bucket of a sample container, the sample container comprising:

a) a bucket comprising:

i) a bucket bottom wall joined around a circumference to a bottom edge of a bucket side wall, a top edge of the bucket side wall circumferentially defining a top opening of the bucket having an internal diameter, and the bottom edge and top edge of the bucket side wall defining a bucket height and a vertical direction therebetween,

wherein an interior surface of the bucket side wall defines an interior circumferential surface and an exterior surface of the bucket side wall defines an exterior circumferential surface, and

wherein the bucket bottom wall comprises an interior surface disposed toward the top opening of the bucket;

ii) a plurality of ridges on the exterior circumferential surface and distributed radially with respect to a bucket central axis and defining grooves between by adjacent ridges, the grooves having a depth of between about 0.2″ to 1″; and

iii) a first threaded engagement portion;

wherein the top opening internal diameter is greater than the bucket height;

b) a lid having a lid central axis, the lid comprising:

i) a lid top wall joined around a circumference to a top edge of a lid side wall, a bottom edge of the lid side wall defining a bottom opening of the lid,

the lid top wall comprising an interior surface disposed to the bottom opening of the lid, and an exterior surface comprising at least one raised gripping feature;

ii) a mated threaded engagement portion removably engageable with the first threaded engagement portion of the bucket; and

iii) a sealing plate movably retained in the lid, the sealing plate having a top surface disposed to the interior surface of the lid top wall, a bottom surface disposed toward the bottom opening of the lid, and a central axis collinear with the lid central axis, wherein the sealing plate completely covers the interior surface of the lid top wall and is rotatable with respect to the lid around the sealing plate central axis,

wherein, when threads of the first threaded engagement portion and the mated threaded engagement portion are engaged with each other, the bucket central axis and the lid central axis are collinear, and the sealing plate seals a junction between the lid and the bucket to form a sealed sample container,

ii) adding buffer solution to the bucket, and

iii) engaging the first threated engagement portion and the mated threaded engagement portion to each other to form a sealed sample container.

2. The method of claim 1 , wherein the buffer solution comprises one or more of a salt and a stabilizing agent.

3. The method of claim 2 , wherein the stabilizing agent comprises a nucleic acid stabilizing agent.

4. A method of collecting a stool sample from a subject, comprising,

a) providing to a subject a sample container and a buffer solution, the sample container comprising:

a) a bucket comprising:

i) a bucket bottom wall joined around a circumference to a bottom edge of a bucket side wall, a top edge of the bucket side wall circumferentially defining a top opening of the bucket having an internal diameter, and the bottom edge and top edge of the bucket side wall defining a bucket height and a vertical direction therebetween,

wherein an interior surface of the bucket side wall defines an interior circumferential surface and an exterior surface of the bucket side wall defines an exterior circumferential surface, and

wherein the bucket bottom wall comprises an interior surface disposed toward the top opening of the bucket;

ii) a plurality of ridges on the exterior circumferential surface and distributed radially with respect to a bucket central axis and defining grooves between by adjacent ridges, the grooves having a depth of between about 0.2″ to 1″; and

iii) a first threaded engagement portion;

wherein the top opening internal diameter is greater than the bucket height;

b) a lid having a lid central axis, the lid comprising:

i) a lid top wall joined around a circumference to a top edge of a lid side wall, a bottom edge of the lid side wall defining a bottom opening of the lid,

the lid top wall comprising an interior surface disposed to the bottom opening of the lid, and an exterior surface comprising at least one raised gripping feature;

ii) a mated threaded engagement portion removably engageable with the first threaded engagement portion of the bucket; and

iii) a sealing plate movably retained in the lid, the sealing plate having a top surface disposed to the interior surface of the lid top wall, a bottom surface disposed toward the bottom opening of the lid, and a central axis collinear with the lid central axis, wherein the sealing plate completely covers the interior surface of the lid top wall and is rotatable with respect to the lid around the sealing plate central axis,

wherein, when threads of the first threaded engagement portion and the mated threaded engagement portion are engaged with each other, the bucket central axis and the lid central axis are collinear, and the sealing plate seals a junction between the lid and the bucket to form a sealed sample container; and

b) receiving from the subject a sealed sample container enclosing

i) a stool sample from the subject, and

ii) at least a portion of the buffer solution.

5. The method of claim 4 , wherein said providing comprises providing packaging for transporting a sealed sample container, and wherein said receiving comprises receiving the packaging containing the sealed sample container.

6. The method of claim 4 , wherein said providing further comprises providing an instruction for collecting a stool sample according to claim 1 .

7. The method of claim 6 , wherein the buffer solution comprises at least one of a salt and a stabilizing agent.

8. The method of claim 7 , wherein the stabilizing agent comprises a nucleic acid stabilizing agent.

9. The method of claim 1 , wherein the top opening internal diameter of the bucket is greater than 4.75″.

10. The method of claim 4 , wherein the top opening internal diameter of the bucket is greater than 4.75″.

11. The method of claim 4 , wherein step a) further comprises providing to the subject bracket for mounting said bucket on or under a seat of a toilet.

12. The method of claim 1 , wherein the sample container has an internal volume of at least 300 ml.

13. The method of claim 1 , wherein the sample container has an internal volume between 300 and 1400 ml.

14. The method of claim 4 , wherein the sample container has an internal volume of at least 300 ml.

15. The method of claim 4 , wherein the sample container has an internal volume between 300 and 1400 ml.

16. The method of claim 1 , wherein the bottom surface of the sealing plate comprises a resilient compressible seating surface that is compressed around the circumference of the top opening of the bucket when the first threaded engagement portion and the mated threaded engagement portion are engaged with each other.

17. The method of claim 16 , wherein the first threaded engagement portion and the mated threaded engagement portion have threads dimensioned such that engaging the first and mated threaded engagement portions by rotation of the lid with respect to the bucket around the lid central axis to a point wherein the compressible seating surface is compressed requires rotation of the lid with respect to the bucket of no more than 180 degrees.

18. The method of claim 4 , wherein the bottom surface of the sealing plate comprises a resilient compressible seating surface that is compressed around the circumference of the top opening of the bucket when the first threaded engagement portion and the mated threaded engagement portion are engaged with each other.

19. The method of claim 18 , wherein the first threaded engagement portion and the mated threaded engagement portion have threads dimensioned such that engaging the first and mated threaded engagement portions by rotation of the lid with respect to the bucket around the lid central axis to a point wherein the compressible seating surface is compressed requires rotation of the lid with respect to the bucket of no more than 180 degrees.

20. The method of claim 1 , wherein the sample container further comprises a raised sample disruption feature on one or more of:

the interior circumferential surface of the bucket side wall,

the interior surface of the bucket bottom,

the bottom surface of the sealing plate,

wherein the sample disruption feature comprises one or more of a ridge and a bump.

21. The method of claim 4 , wherein the sample container further comprises a raised sample disruption feature on one or more of:

the interior circumferential surface of the bucket side wall,

the interior surface of the bucket bottom,

the bottom surface of the sealing plate,

wherein the sample disruption feature comprises one or more of a ridge and a bump.

Assignments (3)
TERMINATION AND RELEASE OF SECURITY INTEREST IN PATENT RIGHTS (REEL/FRAME 69898/0249) Recorded Mar 27, 2026
From: JPMORGAN CHASE BANK, N.A.
To: EXACT SCIENCES CORPORATION
Reel/Frame 075288/0393 →
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 Mar 11, 2019
From: SCHIESTLE, JOSEPH E.; BURGER, KRYSTAL A.; PARMER, TIMOTHY A.; LUNDE, JAD A.; JANG, SAM M.; SCHUELKE, DAVID A.; WOLGEMUTH, DAVID B.; LU, JING YANG
To: EXACT SCIENCES CORPORATION
Reel/Frame 048563/0070 →