Sample collection device

• US 9,211,112 B2
• Filed: 08/16/2012
• Issued: 12/15/2015
• Est. Priority Date: 08/16/2011
• Status: Active Grant

• Current Assignee: Exact Sciences Corporation
• Original Assignee: Exact Sciences Corporation
• Inventors: Lidgard, Graham P., Domanico, Michael J., Fourrier, Keith, Light, James P. II, Castanon, Scott, Kopitzke, Keith
• Primary Examiner(s): Stout, Michael C
• Application Number:
  US13/587,552
• Publication Number:
  US 20130211286A1
• Time in Patent Office: 1,216 Days
• Field of Search: 600/570, 600/572, 422/58, 422/56, 422/61, 422/150, 422/287.6, 422/309.1, 215/332, 220/295
• US Class Current: 1/1
• CPC Class Codes: A61B 10/0038 Devices for taking faeces samples; Faecal examination devices anal receptacles A61F5/451
• CPC Class Codes: B01L 3/50825 Closing or opening means, corks, bungs closures for containers B65D; means for removing stoppers B67B7/02
• CPC Class Codes: G01N 1/38 Diluting, dispersing or mixing samples

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

1. A device for collecting a sample, the device comprising:

a) a body comprising a sample collection chamber bounded on a distal end by a penetrable seal affixed to a recessed sealing surface of the distal end of the body and bounded on a proximal end by a septum comprising an aperture, said penetrable seal being penetrable by a pipette tip or needle;

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

i) an asymmetrical beveled tip at a distal end, said 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) a plurality of stacked coaxial frusta of cones to form a plurality of metering ridges;

and

c) a fecal sample suspension solution in said sample collection chamber, said fecal sample suspension solution comprising Tris buffer, bovine serum albumen, polysorbate 20, sodium azide, sodium chloride, ethylenediaminetetraacetic acid, and gentamicin.

2. The device of claim 1 wherein:

a) the axes of the frusta are coaxial with a longitudinal axis of the sampling rod; and

b) the bases of the frusta face the proximal end of the sampling rod.

3. The device of claim 1 wherein the radii of the bases of the frusta are the same as the radius of the distal end of the sampling rod.

4. The device of claim 1, wherein said cones are right circular cones.

5. The device of claim 1 wherein a cap is attached to said proximal end of said sampling rod, wherein said cap is configured to engage a proximal end of said body.

6. The device of claim 5 wherein said cap and said proximal end of said body have mated threads for securing said cap to said body.

7. The device of claim 1 wherein said aperture has a radius, and wherein said distal portion of said sampling rod has a radius approximately the same as said radius of said aperture and said proximal portion of said sampling rod has a radius larger than said radius of said aperture.

8. The device of claim 7 wherein a junction between said distal portion of said sampling rod and said proximal portion of said sampling rod forms a stopper that seals said aperture when said distal portion of said sampling rod is fully inserted through said aperture.

9. The device of claim 8 wherein said aperture when sealed holds 30 to 100 psi when the device is internally pressurized with air.

10. The device of claim 1 wherein said sampling rod and said aperture are configured such that insertion of said sampling rod through the aperture removes excess sample from said distal portion of said sampling rod and leaves a metered sample in said metering ridges.

11. The device of claim 1 wherein said body is tubular.

12. The device of claim 1 wherein said body has an outer diameter of 14 millimeters.

13. The device of claim 1 wherein at least a portion of said sampling rod is circular in cross section.

14. The device of claim 1 wherein said penetrable seal is made from a foil.

15. The device of claim 1 wherein said penetrable seal holds a pressure of 30 to 100 psi when said device is internally pressurized with air.

16. The device of claim 14 wherein said foil has a thickness of 0.001 inches.

17. The device of claim 1 wherein said penetrable seal comprises a foil layer and a polyester layer.

18. The device of claim 17 wherein said foil layer is 0.001 inch thick and said polyester layer is 0.005 inch thick.

19. The device of claim 1, wherein said sealing surface is recessed 0.125 inches with respect to a distal end of said body.

20. The device of claim 1 further comprising a protective cap adapted to fit on a distal end of said body, wherein said cap covers said penetrable seal.

21. The device of claim 1 wherein said penetrable seal is made from a material selected from the group consisting of paper, rubber, wax, and plastic.

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

23. The device of claim 1, wherein said body and said sampling rod are made from the same material.

24. The device of claim 1, wherein said body and said sampling rod are made from different materials.

25. The device of claim 1 wherein said sampling rod is made from an opaque polypropylene.

26. The device of claim 1 wherein said sampling rod is made from a filled polypropylene.

27. The device of claim 1 wherein said body is made from a transparent polypropylene.

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

29. The device of claim 1 wherein said plurality of metering ridges is configured to retain 20 milligrams of a fecal sample.

30. The device of claim 1 wherein when said sampling rod is fully inserted through said aperture in said septum, said at least one metering ridge remains in contact with said solution regardless of the orientation of the device.

31. The device of claim 1 wherein said fecal sample suspension solution has a volume of 2 milliliters.

32. The device of claim 1, wherein said fecal sample suspension solution comprises 20 mM Tris (pH 7.4), 10% bovine serum albumen, 0.10% polysorbate 20, 0.095% sodium azide, 140 mM sodium chloride, 10 mM ethylenediaminetetraacetic acid, and 15 μ

g/ml gentamicin.

34. A kit for collecting a sample, the kit comprising:

a) the device of claim 1; and

b) an instruction for use.

35. The kit of claim 34 further comprising a package in which to mail said device containing a collected sample.

33. A system for collecting a sample, the system comprising:

a) a sample collection chamber for holding a fecal sample suspension solution comprising Tris buffer, bovine serum albumen, polysorbate 20, sodium azide, sodium chloride, EDTA ethylenediaminetetraacetic acid, and gentamicin;

b) a penetrable seal for sealing said chamber at a recessed sealing surface on an end and configured to allow access to said chamber by penetrating said penetrable seal with a pipette tip or needle;

c) a flexible sampling rod for contacting a sample and acquiring a portion of said sample, said flexible sampling rod comprising an asymmetrical beveled tip comprising an apex at the circumference of the flexible sampling rod and configured to bend the flexible sampling rod away from and/or to deflect collisions with an inserted pipette tip or needle; and

d) a plurality of stacked coaxial frusta of cones to form a plurality of metering ridges for providing into said chamber a defined volume of said acquired portion of the sample.