Integrated lancing test strip with capillary transfer sheet

• US 20060079810A1
• Filed: 10/08/2004
• Published: 04/13/2006
• Est. Priority Date: 10/08/2004
• Status: Active Grant

• Current Assignee: Roche Diabetes Care Inc. (Roche Holding AG)
• Original Assignee: Roche Diagnostics Operations Incorporated (Roche Holding AG)
• Inventors: Patel, Paul, Perez, Edward P.
• Granted Patent: US 7,488,298 B2
• Time in Patent Office: Days
• US Class Current: 600/583
• CPC Class Codes: A61B 5/14532 for measuring glucose, e.g. by tissue impedance measurement

Abstract

An integrated bodily fluid sampling device includes a lancet, a test strip attached to the lancet, and a flexible sheet extending from the test strip. The lancet and the flexible sheet form a gap sized to draw bodily fluid onto the test strip via capillary action. Further, a sampling end portion of the flexible sheet is shaped to enhance capillary action of the sheet. In one form, a removable film covers the lancet and forms a seal with the flexible sheet such that the seal surrounds a lancet tip. In another form, an insulating layer covers a portion of the lancet to prevent electrical interference between the lancet and an electrical testing system on the test strip and ensure an accurate analysis of the bodily fluid.

Claims

1. A device for sampling a bodily fluid from an incision in tissue, comprising:

a lancet to form the incision in the tissue;

a test strip coupled to the lancet for analyzing the bodily fluid from the incision; and

a fluid collection flag extending from the test strip for drawing the bodily fluid to the test strip, the collection flag being flexible to bend during lancing, the collection flag having a sampling end portion having a structure to minimize lateral wicking of the bodily fluid.

2. The device of claim 1, wherein the fluid collection flag is coated with a hydrophilic material.

3. The device of claim 1, wherein the fluid collection flag is transparent to permit viewing of the incision.

4. The device of claim 1, wherein the structure is a fluted shape.

5. The device of claim 1, wherein the structure is a fenestrated shape.

6. The device of claim 1, wherein the structure is a tailed shape.

7. The device of claim 1, wherein the structure is a triangular shape.

8. The device of claim 1, wherein the structure is a semicircular shape.

9. The device of claim 1, wherein the structure is a notched shape.

10. The device of claim 1, wherein the structure is a tapered shape.

11. The device of claim 1, wherein the structure is a rectangular shape defining a hole near an edge.

12. The device of claim 1, wherein:

the lancet includes a lancet tip; and

the sampling end portion extends to the lancet tip.

13. The device of claim 1, wherein:

the test strip includes an electrode; and

an insulating layer covers a portion of the lancet, wherein the insulating layer prevents electrical interference between the lancet and the electrode.

14. The device of claim 13, wherein the insulating layer includes aluminum oxide.

15. The device of claim 13, wherein the insulating layer includes paralyene.

16. The device of claim 13, wherein the insulating layer includes polymer.

17. The device of claim 1, further comprising a protective film detachably coupled to the lancet.

18. The device of claim 17, wherein the protective film includes a lancet engaging surface coated with an adhesive material to cover the lancet.

19. The device of claim 18, wherein the lancet engaging surface includes an end region without adhesive material.

20. The device of claim 17, wherein:

the lancet includes a lancet tip; and

the protective film is detachably coupled to the fluid collection flag for protecting at least the lancet tip, wherein the lancet tip is sandwiched between the fluid collection flag and the protective film.

21. The device of claim 20, wherein the protective film and the fluid collection flag form a seal surrounding the lancet tip.

22. An integrated bodily fluid sampling device for sampling a bodily fluid from an incision in skin, comprising:

a lancet having a lancet tip for forming the incision in the skin;

a test strip coupled to the lancet for analyzing the bodily fluid from the incision;

a fluid collection flag extending from the test strip for drawing the bodily fluid onto the test strip; and

a protective film detachably coupled to the fluid collection flag for protecting at least the lancet tip, wherein the lancet tip is sandwiched between the fluid collection flag and the film.

23. The device of claim 22, wherein the fluid collection flag is coated with a hydrophilic material.

24. The device of claim 22, wherein the protective film includes a lancet engaging surface coated with an adhesive material to cover the lancet.

25. The device of claim 22, wherein the protective film and the fluid collection flag form a seal for surrounding the lancet tip.

26. The device of claim 22, wherein the fluid collection flag includes a sampling end portion having a structure to minimize lateral wicking of the bodily fluid.

27. The device of claim 26, wherein the structure is a fluted shape.

28. The device of claim 26, wherein the structure is a fenestrated shape.

29. The device of claim 26, wherein the structure is a tailed shape.

30. The device of claim 26, wherein the structure is a triangular shape.

31. The device of claim 26, wherein the structure is a semicircular shape.

32. The device of claim 26, wherein the structure is a notched shape.

33. The device of claim 26, wherein the structure is a tapered shape.

34. The device of claim 26, wherein the structure is a rectangular shape defining a hole near an edge.

35. An integrated bodily fluid sampling device for sampling and testing a body fluid sample from an incision in skin, comprising:

a lancet having a lancet tip for forming the incision in the skin;

a test strip having electrodes for testing a body fluid sample, the test strip attached to the lancet;

an insulating layer covering a portion of the lancet, the insulating layer preventing electrical interference between the lancet and the electrodes; and

a fluid collection flag extending from the test strip for drawing the bodily fluid onto the test strip.

36. The device of claim 35, wherein the insulating layer includes aluminum oxide.

37. The device of claim 35, wherein the insulating layer includes paralyene.

38. The device of claim 35, wherein the insulating layer includes polymer.

39. The device of claim 35, wherein the fluid collection flag includes a sampling end portion having a structure to minimize lateral wicking of the bodily fluid.

40. The device of claim 35, further comprising a protective film detachably coupled to the lancet.

41. A body fluid sampling device, comprising:

means for forming an incision in tissue;

means for analyzing body fluid from the incision; and

a fluid collection sheet to draw the body fluid to said means for analyzing the body fluid, wherein the fluid collection sheet includes means for reducing lateral wicking of the body fluid along the fluid collection sheet.

42. The device of claim 41, wherein the means for reducing lateral wicking of the body fluid along the fluid collection sheet includes a sampling end portion having a triangular shape.

43. A method of drawing a body fluid, comprising:

providing a sampling device with a fluid collection flag, the fluid collection flag configured to minimize lateral wicking of the body fluid;

contacting a drop of the body fluid with the fluid collection flag; and

drawing the body fluid longitudinally along a length of the fluid collection flag with the fluid collection flag.

44. The method of claim 43, further comprising:

forming an incision in skin with a lancet of the sampling device.

45. The method of claim 44, further comprising:

collecting the body fluid with a test strip of the sampling device.

46. The method of claim 45, further comprising:

covering a portion of the lancet with an insulating layer, the insulating layer preventing electrical interference between the lancet and the test strip.

47. The method of claim 44, further comprising:

sandwiching at least a lancet tip of the lancet between a protective film and the fluid collection flag to maintain sterility of the lancet tip; and

removing the protective film upon use of the sampling device.

48. The method of claim 47, further comprising:

applying an adhesive to a lancet engaging surface of the protective film; and

attaching the lancet engaging surface to the fluid collection flag.

49. A method, comprising:

providing an sampling device with a lancet that has a lancet tip configured to form an incision and a test means configured to analyze body fluid from the incision; and

sandwiching at least the lancet tip of the lancet between a protective film and a fluid collection flag to maintain sterility of the lancet tip, wherein the fluid collection flag is configured to draw the body fluid towards the test means.

50. The method of claim 49, further comprising:

applying an adhesive to a lancet engaging surface of the protective film; and

attaching the lancet engaging surface to the fluid collection flag.

51. The method of claim 49, further comprising:

separating the protective film from the fluid collection flag upon use of the sampling device.

52. The method of claim 49, further comprising:

wherein the test means includes an electrode; and

covering a portion of the lancet with an insulating layer, the insulating layer preventing electrical interference between the lancet and the electrode.

53. The method of claim 49, further comprising:

coating the fluid collection flag with a hydrophilic material.