Integrated lancing test strip with capillary transfer sheet

• US 7,488,298 B2
• Filed: 10/08/2004
• Issued: 02/10/2009
• Est. Priority Date: 10/08/2004
• Status: Expired due to Fees

• Current Assignee: Roche Diabetes Care Inc. (Roche Holding AG)
• Original Assignee: Roche Diagnostics Operations Incorporated (Roche Holding AG)
• Inventors: Patel, Paul, Perez, Edward P.
• Primary Examiner(s): Hindenburg; Max
• Assistant Examiner(s): TOWA, RENE T
• Application Number:
  US10/961,640
• Publication Number:
  US 20060079810A1
• Time in Patent Office: 1,586 Days
• Field of Search: 600/573, 600/576, 600583-584, 600/578
• US Class Current: 600/584
• 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. 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 attached to the lancet for analyzing the bodily fluid from the incision, the lancet being fixed to the test strip;

a fluid collection flag having a sampling end portion extending from the test strip for drawing the bodily fluid onto the test strip, the sampling end portion is at least as long as the lancet, the collection flag being flexible to bend against the tissue during lancing wherein the collection flag is resilient to maintain the shape of the collection flag after contact with the tissue, the sampling end portion having a structure to minimize lateral wicking of the bodily fluid; 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 and contacts both the fluid collection flag and the film.

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 protective film includes a lancet engaging surface coated with an adhesive material to cover the lancet.

4. The device of claim 3, wherein the lancet engaging surface includes an end region without adhesive material.

5. The device of claim 1, wherein the protective film and the fluid collection flag form a seal for surrounding the lancet tip.

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

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

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

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

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

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

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

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

14. The device of claim 1, further comprising:

a spacer defining a capillary channel, the spacer sandwiched between the lancet and the test strip; and

the fluid collection flag located exteriorly of the capillary channel.

15. The device of claim 1, wherein the test strip is sandwiched between the lancet and the fluid collection flag.

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

17. 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.

18. The device of claim 17, wherein the insulating layer includes aluminum oxide.

19. The device of claim 17, wherein the insulating layer includes polyparaxylene.

20. The device of claim 17, wherein the insulating layer includes polymer.

21. The device of claim 1, wherein the protective film is permanently attached to the device to form a second fluid collection flag.

22. A device for sampling a body fluid from an incision in skin, comprising:

a lancet having a lancet tip to form the incision in skin;

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

a flexible fluid collection flag having a sampling end portion for drawing the body fluid to the test strip, the fluid collection flag attached to the test strip wherein the sampling end portion extends from the test strip, the sampling end portion having a fluted shape with a plurality of ridges that enable the sampling end portion to bend against the skin during lancing, wherein the ridges stiffen the collection flag to allow the collection flag to resiliently extend to its original position after lancing when the lancet tip is retracted from the incision.

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 fluid collection flag is transparent to permit viewing of the incision.

25. The device of claim 22, further comprising:

the lancet and the sampling end portion define a gap configured to draw the bodily fluid onto the test strip by capillary action.

26. The device of claim 22, 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.

27. The device of claim 22, wherein:

the sampling end portion includes an edge angled in a zig-zag shape to minimize lateral wicking of body fluid along the length of the fluid collection flag.

28. The device of claim 22, further comprising:

a protective film detachably coupled to the fluid collection flag, wherein the protective film and the fluid collection flag form a seal for surrounding the lancet tip.

29. The device of claim 28, wherein the lancet tip is sandwiched between and contacts both the fluid collection flag and the protective film.

30. The device of claim 28, wherein the protective film is permanently attached to the device to form a second fluid collection flag.

31. The device of claim 28, wherein the protective film includes a lancet engaging surface coated with an adhesive material to cover the lancet.

32. The device of claim 31, wherein the lancet engaging surface includes an end region without adhesive material.

33. A device for sampling a body fluid from an incision in skin, comprising:

a lancet having a lancet tip to form the incision in skin;

a test strip coupled to the lancet for analyzing the body fluid from the incision, the lancet being fixed to the test strip; and

a flexible fluid collection flag having a sampling end portion for drawing the body fluid to the test strip, the fluid collection flag attached to the test strip wherein the sampling end portion extends from the test strip and extends past the lancet tip, the sampling end portion having a fluted shape with a plurality of ridges that enable the sampling end portion to bend against the skin during lancing, wherein the ridges stiffen the collection flag to allow the collection flag to resiliently extend to its original position after lancing when the lancet tip is retracted from the incision.

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

a lancet having a lancet tip to form the incision in the tissue;

a test strip attached to the lancet for analyzing the bodily fluid from the incision, the lancet being immovable with respect to the test strip; and

a fluid collection flag having a sampling end portion for drawing the bodily fluid to the test strip, the fluid collection flag attached to the test strip wherein the sampling end portion extends from the test strip and is at least as long as the lancet, the collection flag being flexible to bend against the tissue during lancing wherein the collection flag is resilient to maintain the shape of the collection flag after contact with the tissue, the sampling end portion having a fenestrated shape to minimize lateral wicking of the bodily fluid, wherein the fenestrated shape includes a plurality of slits in the sampling end portion.

35. The device of claim 34, wherein the fluid collection flag is coated with a hydrophilic material.

36. The device of claim 34, wherein the fluid collection flag is transparent to permit viewing of the incision.

37. The device of claim 34, 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.

38. The device of claim 34, further comprising a protective film detachably coupled to the lancet.

39. The device of claim 38, wherein the protective film includes a lancet engaging surface coated with an adhesive material to cover the lancet.