SAMPLE COLLECTION DEVICE

• US 20130211286A1
• Filed: 08/16/2012
• Published: 08/15/2013
• 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., Light, James P. II, Castanon, Scott, Kopitzke, Keith, Fourrier, Keith
• Granted Patent: US 9,211,112 B2
• Time in Patent Office: Days
• US Class Current: 600/562
• 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 and bounded on a proximal end by a septum, said septum comprising an aperture;

b) a 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 angled tip at a distal end; and

ii) at least one metering ridge;

and

c) a solution in said sample collection chamber, said solution comprising Tris buffer, bovine serum albumen, Tween-20, sodium azide, sodium chloride, EDTA, and gentamicin.

2. The device of claim 1 wherein said at least one metering ridge comprises a frustum of a cone.

3. The device of claim 2 wherein:

a) an axis of the frustum is coaxial with a longitudinal axis of the sampling rod; and

b) a base of the frustum faces the proximal end of the sampling rod.

4. The device of claim 2 wherein the radius of the base of the frustum is approximately the same as the radius of the distal end of the sampling rod.

5. The device of claim 2 comprising a plurality of stacked coaxial frusta to form a plurality of metering ridges.

6. The device of claim 2, wherein said cone is a right circular cone.

7. The device of claim 1 wherein said sampling rod is flexible.

8. 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.

9. The device of claim 8 wherein said cap and said proximal end of said body have mated threads for securing said cap to said body.

10. 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.

11. The device of claim 10 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.

12. The device of claim 11 wherein said aperture when sealed holds a minimum of 30 psi when the device is internally pressurized with air.

13. 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 ridge.

14. The device of claim 1 wherein said penetrable seal is penetrable by a pipette tip or needle.

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

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

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

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

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

20. The device of claim 18 wherein said foil has a thickness of approximately 0.001 inches.

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

22. The device of claim 21 wherein said foil layer is 0.001 inch thick and said polyester layer is 0.005 inch thick.

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

24. The device of claim 23 wherein said sealing surface is recessed.

25. The device of claim 24, wherein said sealing surface is recessed 0.125 inches with respect to a distal end of said body.

26. 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.

27. 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.

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

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

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

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

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

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

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

35. The device of claim 1 wherein said at least one metering ridge retains a sample of approximately 20 milligrams.

36. 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.

37. The device of claim 1 wherein said solution has a volume of approximately 2 milliliters.

38. The device of claim 1, wherein said solution comprises approximately 20 mM Tris (pH 7.4), 10% bovine serum albumen, 0.10% Tween-20, 0.095% sodium azide, 140 mM sodium chloride, 10 mM EDTA, and 15 μ

g/ml gentamicin.

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

a) the device of claim 1; and

b) an instruction for use.

41. The kit of claim 40 further comprising a package in which to mail said device containing a collected sample.

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

a) a chamber functionality for holding a sample re-suspension solution;

b) a penetrable seal functionality for sealing said chamber on an end and allowing access to said chamber by penetrating said penetrable seal functionality;

c) a sampling functionality for contacting a sample and acquiring a portion of said sample;

d) a metering functionality for providing into said chamber functionality a defined volume of said acquired portion of the sample.