Apparatus and method for extracting bodily fluid utilizing a flat lancet

• US 20060030788A1
• Filed: 08/04/2004
• Published: 02/09/2006
• Est. Priority Date: 08/04/2004
• Status: Abandoned Application

• Current Assignee: Roche Diabetes Care Inc. (Roche Holding AG)
• Original Assignee: Roche Diabetes Care Inc. (Roche Holding AG)
• Inventors: Roe, Steven N., Wong, Daniel, Raney, Charles C., Patel, Paul
• Application Number:
  US10/911,252
• Publication Number:
  US 20060030788A1
• Time in Patent Office: Days
• US Class Current: 600/583
• CPC Class Codes: A61B 5/14514 using means for aiding extraction of interstitial fluid, e.g. microneedles or suction
• CPC Class Codes: A61B 5/150022 for capillary blood or interstitial fluid
• CPC Class Codes: A61B 5/150106 Means for reducing pain or discomfort applied before puncturing; desensitising the skin at the location where body is to be pierced
• CPC Class Codes: A61B 5/150175 Adjustment of penetration depth
• CPC Class Codes: A61B 5/150213 Venting means
• CPC Class Codes: A61B 5/150282 for piercing elements, e.g. blade, lancet, canula, needle
• CPC Class Codes: A61B 5/150358 Strips for collecting blood, e.g. absorbent optical reagent test strips G01N21/8483; chemical reagent test strips G01N33/4875, G01N33/52
• CPC Class Codes: A61B 5/150458 Specific blade design, e.g. for improved cutting and penetration characteristics
• CPC Class Codes: A61B 5/150465 Specific design of proximal end
• CPC Class Codes: A61B 5/150503 Single-ended needles hollow piercing element tip design A61B5/150396, needle sets for catheters A61M25/06, needles for bringing media into the body A61M5/32
• CPC Class Codes: A61B 5/15113 Manually triggered, i.e. the triggering requires a deliberate action by the user such as pressing a drive button
• CPC Class Codes: A61B 5/1519 comprising driving means, e.g. a spring, for propelling the piercing unit
• CPC Class Codes: A61B 5/157 Devices characterised by integrated means for measuring characteristics of blood

Abstract

A bodily fluid sampling device is operable to rupture the skin surface at normal and oblique angles utilizing a flat lancet of specified thickness and at least one cutting surface inclined less than eighty degrees (80°) from the longitudinal axis of the flat lancet. The flat lancet thickness and cutting surface geometry minimize pain while maximizing the amount of emerged bodily fluid. The device limits the depth to which the flat lancet penetrates the skin to further minimize pain and may urge the bodily fluid from the rupture site. The bodily fluid emerging from the rupture site is transported to a test device that tests the bodily fluid for particular properties and characteristics.

Claims

1. An apparatus, comprising:

a flat lancet adapted to form a breach in the skin surface, said lancet including a longitudinal axis, a thickness being at least 0.05 millimeters and at most 0.15 millimeters to minimize the pain associated with the lancet penetrating the skin, a width being at least 0.1 millimeters and at most 1.5 millimeters, a first cutting edge adapted to penetrate the skin, and a second cutting edge adapted to penetrate the skin, wherein said first and second cutting edges are each inclined at least thirty degrees (30°

) and at most forty degrees (40°

) from said longitudinal axis; and

an actuation member attached to said flat lancet, wherein said actuation member moves said first cutting edge to penetrate the skin.

2. An apparatus, comprising:

a flat lancet adapted to form a breach in the skin surface, said lancet including a longitudinal axis, a thickness, and a first cutting edge adapted to penetrate the skin, wherein said first cutting edge is inclined less than eighty degrees (80°

) from said longitudinal axis and said thickness is at least 0.05 millimeters and at most 0.3 millimeters to minimize the pain associated with the lancet penetrating the skin; and

an actuation member attached to said flat lancet, wherein said actuation member moves said first cutting edge to penetrate the skin.

3. The apparatus of claim 2, wherein said first cutting edge is inclined at least ten degrees (10°

) and at most sixty degrees (60°

) from said longitudinal axis.

4. The apparatus of claim 3, wherein said first cutting edge is inclined at least thirty degrees (30°

) and at most forty degrees (40°

) from said longitudinal axis.

5. The apparatus of claim 2, wherein said thickness is at least 0.05 millimeters and at most 0.15 millimeters.

6. The apparatus of claim 2, wherein said longitudinal axis is oriented less than ninety degrees (90°

) from the skin surface when said flat lancet penetrates the skin.

7. The apparatus of claim 6, wherein said longitudinal axis is oriented at least forty-five degrees (45°

) and at most sixty degrees (60°

) from the skin surface when said flat lancet penetrates the skin.

8. The apparatus of claim 2, wherein said flat lancet further comprises a shank.

9. The apparatus of claim 2 further comprising a depth stop, wherein said depth stop prevents said cutting portion from penetrating the skin past a predetermined depth.

10. The apparatus of claim 2, further comprising an expressing device, wherein said expressing device urges bodily fluid from the breach in the skin surface.

11. The apparatus of claim 10, further comprising a test device, wherein said test device tests the bodily fluid for particular properties.

12. The apparatus of claim 11, further comprising a sampling device, wherein said sampling device moves the bodily fluid from the breach in the skin surface to said test device.

13. The apparatus of claim 2, wherein said first cutting edge is concave.

14. The apparatus of claim 2, wherein said flat lancet further includes a width, wherein said width is at least 0.1 millimeters and at most 1.5 millimeters.

15. The apparatus of claim 2, further comprising a second cutting edge adapted to penetrate the skin, wherein said second cutting edge is inclined less than eighty degrees (80°

) from said longitudinal axis.

16. The apparatus of claim 15, wherein said second cutting edge is inclined at least ten degrees (10°

) and at most sixty degrees (60°

) from said longitudinal axis.

17. The apparatus of claim 16, wherein said second cutting edge is inclined at least fifteen degrees (15°

) and at most twenty degrees (20°

) from said longitudinal axis.

18. The apparatus of claim 15, wherein said first and second cutting edges are symmetrically inclined from said longitudinal axis.

19. The apparatus of claim 15, wherein said second cutting edge is concave.

20. The apparatus of claim 15 further comprising a cutting surface, wherein said second cutting edge is similarly shaped to said first cutting edge and said cutting surface is bounded on two sides by said first cutting edge and said second cutting edge.

21. The apparatus of claim 20, wherein said cutting surface is concave.

22. The apparatus of claim 15 further comprising a third cutting edge, a fourth cutting edge, a first cutting surface, and a second cutting surface;

wherein said first cutting surface is bounded on two sides by said first cutting edge and said third cutting edge, and said second cutting surface is bounded on two sides by said second cutting edge and said fourth cutting edge.

23. The apparatus of claim 22, wherein said third cutting edge is similarly shaped to said first cutting edge and said fourth cutting edge is similarly shaped to said second cutting edge.

24. The apparatus of claim 23, wherein said second cutting surface is concave.

25. A method, comprising:

placing a sampling device in contact with the skin, the sampling device including a generally planar lancet, the generally planar lancet having a thickness of at least 0.05 millimeters and at most 0.3 millimeters, and the generally planar lancet having at least one cutting edge;

moving the generally planar lancet in relation to the skin surface and along a translation axis; and

penetrating the skin surface at a penetration site with the generally planar lancet wherein the at least one cutting edge is inclined less than eighty degrees (80°

) from the translation axis.

26. The method of claim 25, wherein the at least one cutting edge is inclined at least ten degrees (10°

) and at most sixty degrees (60°

) from the translation axis.

27. The method of claim 26, wherein the at least one cutting edge is inclined at least thirty degrees (30°

) and at most forty degrees (40°

) from the translation axis.

28. The method of claim 25, wherein said penetrating occurs with the translation axis oriented less than ninety degrees (90°

) from the skin surface.

29. The method of claim 28, wherein said penetrating occurs with the translation axis oriented at least forty-five degrees (45°

) and at most sixty degrees (60°

) with respect to the skin surface at the point where the translation axis intersects the skin surface.

30. The method of claim 28, wherein the translation axis is curved.

31. The method of claim 25, wherein the generally planar lancet thickness is at least 0.05 millimeters and at most 0.15 millimeters.

32. The method of claim 25, wherein said penetrating terminates at a predetermined depth.

33. The method of claim 25, further comprising urging bodily fluid from the penetration site.

34. The method of claim 33, further comprising transporting the bodily fluid to a test device.

35. The method of claim 34, further comprising testing the fluid released after said penetrating.

36. The method of claim 25, further comprising removing the generally planar lancet from the skin surface.

37. An apparatus for extracting bodily fluid, comprising:

an incision forming member adapted for cutting the skin surface, wherein said incision forming member includes a side surface and at least one cutting facet inclined less than eighty degrees (80°

) from said side surface, and wherein said incision forming member has a thickness greater than 0.05 millimeters and less than 0.3 millimeters; and

means for moving at least a portion of said incision forming member below the skin surface at an incision location.

38. The apparatus of claim 37, wherein said at least one cutting facet is inclined at least thirty degrees (30°

) and at most forty degrees (40°

) from said side surface.

39. The apparatus of claim 37, wherein said incision forming member is at least 0.05 millimeters and at most 0.15 millimeters thick.

40. The apparatus of claim 37, wherein said means for moving includes penetrating the skin surface at an angle less than ninety degrees (90°

).

41. The apparatus of claim 37 further comprising an expressing member, wherein said expressing member expresses bodily fluid from the incision location.

42. The apparatus of claim 41 further comprising a test device, wherein said test device tests the bodily fluid for particular properties.

43. The apparatus of claim 42 further comprising means for transporting the bodily fluid to said test device.

44. The apparatus of claim 37, wherein said means for moving includes removing at least a portion of said incision forming member from below the skin surface.

45. The apparatus of claim 37, wherein said means for moving includes a means for moving said incision forming member along a curved path.

46. An apparatus for rupturing the skin, comprising:

a flat lancet for rupturing the skin at a rupture site, said flat lancet comprising a first side and a cutting surface, said cutting surface produced by photoetching, wherein said photoetching is performed on said first side; and

an actuation member, wherein said actuation member moves said flat lancet to rupture the skin at the rupture site.

47. The apparatus of claim 46, wherein said cutting surface is concave.

48. The apparatus of claim 46 further comprising a second side, wherein said photoetching is further performed on said second side.

49. The apparatus of claim 48 further comprising a first cutting edge and a second cutting edge, wherein said first cutting edge is formed by the intersection of said cutting surface and said first side, and said second cutting edge is formed by the intersection of said cutting surface and said second side, and wherein the plane intersecting said first cutting edge and said second cutting edge is perpendicular to said first side.

50. The apparatus of claim 46, wherein said actuation member moves said flat lancet along a curved path.

51. The apparatus of claim 46, wherein said actuation member moves said flat lancet to rupture the skin at an angle less than ninety degrees (90°

) from the skin surface.

52. The apparatus of claim 51, wherein said actuation member moves said flat lancet to rupture the skin at an angle at least forty-five degrees (45°

) and at most sixty degrees (60°

) from the skin surface.

53. The apparatus of claim 46, wherein said actuation member removes said flat lancet from the rupture site.

54. The apparatus of claim 46 further comprising an urging member for urging bodily fluid from the rupture site.

55. The apparatus of claim 54 further comprising a test device for testing the bodily fluid for particular properties.

56. The apparatus of claim 55 further comprising a sampling member for transporting the bodily fluid from the rupture site to the test device.