FLEXIBLE LANCET

• US 20080300509A1
• Filed: 05/29/2008
• Published: 12/04/2008
• Est. Priority Date: 05/29/2007
• Status: Active Grant

• Current Assignee: Roche Diabetes Care Inc. (Roche Holding AG)
• Original Assignee: Roche Diabetes Care Inc. (Roche Holding AG)
• Inventors: Hoenes, Joachim, Kraemer, Uwe
• Granted Patent: US 9,138,179 B2
• Time in Patent Office: Days
• US Class Current: 600/583
• CPC Class Codes: A61B 5/1411 by percutaneous method, e.g. by lancet
• CPC Class Codes: A61B 5/14532 for measuring glucose, e.g. by tissue impedance measurement
• CPC Class Codes: A61B 5/150022 for capillary blood or interstitial fluid
• 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 5/150412 Pointed piercing elements, e.g. needles, lancets for piercing the skin blade-like piercing elements A61B5/150442
• 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 5/150526 Curved or bent needles
• CPC Class Codes: A61B 5/151 Devices specially adapted for taking samples of capillary blood, e.g. by lancets , needles or blades
• CPC Class Codes: A61B 5/15128 comprising 2D- or 3D-shaped elements, e.g. cams, curved guide rails or threads comprising tooth-shaped elements A61B5/15132
• CPC Class Codes: A61B 5/15142 Devices intended for single use, i.e. disposable
• CPC Class Codes: A61B 5/15146 Devices loaded with multiple lancets simultaneously, e.g. for serial firing without reloading, for example by use of stocking means. multiple simultaneous cutting or piercing A61B5/150977
• CPC Class Codes: A61B 5/15153 Multiple piercing elements stocked in a single compartment
• CPC Class Codes: A61B 5/15169 Characterized by a rolled strip
• CPC Class Codes: A61B 5/15171 Characterized by propelling the piercing element perpendicular to the direction of movement of the strip
• CPC Class Codes: A61B 5/15173 Characterized by propelling the piercing element parallel to the direction of movement of the strip
• CPC Class Codes: A61B 5/15178 Stocking means comprising separate compartments or units for new and for used piercing elements separate compartments for used piercing elements in piercing devices A61B5/15184
• CPC Class Codes: A61B 5/15186 Devices loaded with a single lancet, i.e. a single lancet with or without a casing is loaded into a reusable drive device and then discarded after use; drive devices reloadable for multiple use

Abstract

A system for withdrawing body fluid is described which has a housing with at least one opening and at least one lancet which is elongate and substantially straight in its original and unused form. The lancet has a distal end with a lancet tip for carrying out a lancing operation. The system also includes a drive unit for driving the lancet in a drive direction and at least one guide element which makes contact with the lancet at least during the lancing operation and guides the lancet movement such that the lancet is bent relative to the drive direction. The lancet can have a high restoring force such that it returns to its original substantially straight shape after contacting the guide element.

Claims

1. A system for withdrawing body fluid, comprising:

a housing having an opening;

a lancet having a lancet body and a tip, the lancet being configured substantially straight before use;

a drive unit for moving the lancet in a drive direction during a lancing operation; and

a guide element which contacts and bends the lancet relative to the drive direction during the lancing operation.

2. The system of claim 1, wherein the lancet comprises a restoring force which restores the lancet to the substantially straight configuration when the lancet is separated from the guide element.

3. The system of claim 1, wherein the lancet is flexible and substantially flat.

4. The system of claim 1, wherein the guide element comprises metal, ceramic, glass or plastic.

5. The system of claim 1, wherein the lancet is moved through the guide element during the lancing operation.

6. The system of claim 1, wherein the guide element is a rail.

7. The system of claim 6, wherein the rail comprises two rails.

8. The system of claim 1, wherein the guide element bends the lancet to a curved shape during the lancing operation.

9. The system of claim 1, wherein the guide element reorients the tip relative to the drive direction during the lancing operation.

10. The system of claim 1, wherein the guide element reorients the tip between 5°

and 90°

relative to the drive direction during the lancing operation.

11. The system of claim 1, wherein the guide element reorients the tip about 90°

relative to the drive direction during the lancing operation.

12. The system of claim 1, wherein the guide element couples to the housing during the lancing operation.

13. The system of claim 1, wherein, prior to use, the lancet is disposed in a lancet magazine.

14. The system of claim 13, wherein the guide element is connected to the magazine.

15. The system of claim 1, wherein the lancet is arranged on a tape.

16. A lancet storage apparatus for use with a lancing aid, comprising:

a plurality of lancets each comprising a tip;

a guide element, wherein during use of the storage apparatus with the lancing aid during a lancing operation, the guide element contacts and bends an active one of the plurality of lancets and reorients the tip of the active lancet to perform a puncture.

17. The lancet storage apparatus of claim 16, wherein, after the lancing operation, the active lancet separates from the guide element and returns to an unbent form.

18. The lancet storage apparatus of claim 16, further comprising a carrier on which the plurality of lancets is arranged.

19. The lancet storage apparatus of claim 18, wherein the carrier and the plurality of lancets are formed in one piece.

20. The lancet storage apparatus of claim 18, wherein, prior to use, each of the plurality of lancets comprises an unbent configuration in which each lancet is arranged substantially horizontally on the carrier.

21. The lancet storage apparatus of claim 20, wherein the tip of the active lancet extends from the carrier when the tip is reoriented.

22. The lancet storage apparatus of claim 21, wherein, after the lancing operation, the active lancet returns to the unbent configuration.

23. The lancet storage apparatus of claim 18, further comprising a plurality of test elements arranged on the carrier.

24. The lancet storage apparatus of claim 23, wherein the plurality of lancets and the plurality of test elements comprise a side by side arrangement.

25. The lancet storage apparatus of claim 24, wherein, during the lancing operation, the active lancet makes contact with an active test element after the reorientation of the tip of the active lancet.

26. The lancet storage apparatus of claim 18, wherein the carrier comprises a carrier tape.

27. The lancet storage apparatus of claim 18, wherein the carrier is substantially disk shaped.

28. The lancet storage apparatus of claim 16, further comprising a magazine in which the plurality of lancets are arranged.

29. The lancet storage apparatus of claim 28, wherein the plurality of lancets are stacked in the magazine.

30. The lancet storage apparatus of claim 16, wherein the guide element is disposed in the magazine.

31. The lancet storage apparatus of claim 16, wherein, during the lancing operation, the guide element moves together with the active lancet.

32. A method for puncturing a body part using a lancing aid comprising a housing and a lancet disposed in the housing, the lancet having a tip and a lancet body, the method comprising:

moving the lancet in a drive direction during a lancing operation;

bending the lancet with a guide element during the lancing operation such that the tip is reoriented relative to the drive direction; and

puncturing the body part with the tip.

33. The method of claim 32, further comprising guiding the lancet along the guide element during the lancing operation.

34. The method of claim 32, wherein the bending step comprises contacting the guide element with one side of the lancet.

35. The method of claim 32, wherein the bending step comprises contacting the guide element with two sides of the lancet.

36. The method of claim 32, wherein the guide element at least partially surrounds the lancet during the bending step.

37. The method of claim 32, further comprising reshaping the lancet from substantially straight to curved during the bending step.

38. The method of claim 32, further comprising reorienting the tip relative to the drive direction during the lancing operation.

39. The method of claim 32, further comprising reorienting the tip between 5°

and 90°

relative to the drive direction during the lancing operation.

40. The method of claim 32, further comprising reorienting the tip about 90°

relative to the drive direction during the lancing operation.

41. The method of claim 32, wherein, during the bending step, the guide element encircles a portion of the lancet.

42. The method of claim 32, further comprising destroying or piercing a sterile protector which covers the tip during the lancing operation.

43. The method of claim 32, further comprising:

moving the guide element and lancet toward an opening of the housing;

then preventing further movement of the guide element; and

using the guide element to guide the lancet to perform the puncture.

44. The method of claim 43, wherein the preventing step comprises coupling the guide element to the housing.

45. The method of claim 32, further comprising providing the lancet on a carrier.

46. The method of claim 45, wherein, during the bending step, the guide element bends the lancet tip away from the carrier.

47. The method of claim 45, further comprising, after the puncture, winding the used lancet and a portion of the carrier on which the lancet is arranged onto a spool.

48. The method of claim 45, further comprising unwinding an unused lancet and portion of the carrier on which the lancet is arranged from a spool.

49. The method of claim 45, further comprising transferring a body fluid sample obtained from the puncture from the tip to a test element arranged on the carrier.

50. The method of claim 32, further comprising, after the puncture, moving a test element into contact with the lancet to transfer a body fluid sample to the test element.

51. The method of claim 32, further comprising returning the lancet to a substantially straight form after the puncture.

52. The method of claim 32, wherein, before the bending step, the lancet is substantially flat.

53. A device for withdrawing body fluid, comprising:

a housing having an opening;

a substantially planar carrier tape disposed in the housing;

a lancet having a lancet body and tip, the lancet being arranged substantially flat on the carrier tape;

a drive element for driving the lancet in a drive direction during a lancing operation; and

a guide element that contacts and bends the lancet during the lancing operation such that the lancet tip is reoriented relative to the drive direction.

54. The device of claim 53, wherein the lancet returns to the substantially flat arrangement on the carrier tape after use.

55. The device of claim 53, wherein the lancet separates from the guide element and returns to an unbent form after use.

56. The device of claim 53, further comprising a test element arranged on the carrier tape.

57. The device of claim 56, wherein the lancet and test element are arranged side by side on the carrier tape.

58. The device of claim 56, wherein, after the reorientation of the tip, the lancet contacts the test element to transfer a body fluid sample.

59. The device of claim 53, further comprising a sterile protector that covers the lancet tip before the lancing operation.

60. The device of claim 53, wherein the reoriented tip is substantially orthogonal to the drive direction.

61. The device of claim 53, wherein the tip comprises a capillary.

62. The device of claim 53, wherein the lancet comprises a bending region and a rigid region, the bending region being located near the tip and the rigid region being connected to the carrier tape.

63. The device of claim 53, further comprising a supply spool and take-up spool.

64. The device of claim 63, wherein, during use, an unused lancet is unwound from the supply spool and is then wound onto the take-up spool after use.

65. The device of claim 64, wherein the lancet comprises a plurality of lancets.

66. The device of claim 53, wherein the guide element reorients the tip relative to the lancet body.

67. The device of claim 53, wherein the guide element reorients the tip between 5°

to 90°

relative to the lancet body.

68. The device of claim 53, wherein the guide element reorients the tip about 90°

relative to the lancet body.

69. The device of claim 53, wherein the drive element and guide element are movable relative to the opening.

70. The device of claim 69, wherein, after the lancing operation and as the drive element and guide element are moved away from the opening, a detector is moved near the opening to detect a body fluid sample.

71. The device of claim 53, wherein the lancet is aligned substantially parallel to a longitudinal direction of the carrier tape.

72. The device of claim 53, wherein the lancet is aligned substantially transverse to a longitudinal direction of the carrier tape.

73. The device of claim 53, further comprising a stop element that is integrated into the housing or guide element, wherein, when the tip reaches a maximum puncturing depth, the stop element engages a thickened portion of the lancet body.

74. The device of claim 73, wherein the position of the stop element can be varied to adjust the puncturing depth of the tip.

75. The device of claim 53, wherein the lancet comprises a substantially flat shape.