PRICKING DEVICE FOR TAKING BLOOD

• US 20070293882A1
• Filed: 06/04/2007
• Published: 12/20/2007
• Est. Priority Date: 12/02/2004
• Status: Abandoned Application

• Current Assignee: Roche Diabetes Care Inc. (Roche Holding AG)
• Original Assignee: Roche Diabetes Care Inc. (Roche Holding AG)
• Inventors: Harttig, Herbert, Winheim, Sven, Deck, Frank
• Application Number:
  US11/757,759
• Publication Number:
  US 20070293882A1
• Time in Patent Office: Days
• US Class Current: 606/181
• CPC Class Codes: A61B 5/150022 for capillary blood or interstitial fluid
• CPC Class Codes: A61B 5/150297 for piercing devices, i.e. devices ready to be used for lancing or piercing for piercing elements A61B5/150282, for driving devices A61B5/15029
• 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 5/150465 Specific design of proximal end
• CPC Class Codes: A61B 5/150519 Details of construction of hub, i.e. element used to attach the single-ended needle to a piercing device or sampling device
• CPC Class Codes: A61B 5/150893 by indicating if used, tampered with, unsterile or defective
• CPC Class Codes: A61B 5/150916 by blocking components, e.g. piston, driving device or fluid passageway
• CPC Class Codes: A61B 5/15105 Purely manual piercing, i.e. the user pierces the skin without the assistance of any driving means or driving devices
• 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 5/15144 comprising driving means, e.g. a spring, for retracting the piercing unit into the housing

Abstract

The present invention provides a pricking device for taking blood comprising a contact element for being placed into contact with an extraction surface, an actuating element for manual actuation of the pricking device, a pricking element which is used to perforate the extraction surface, the pricking element being arranged in the contact element in such a way that it does not protrude from the contact element before the pricking procedure is initiated, and in such a way that a defined pricking depth is obtained during the pricking procedure. The pricking device further includes a return spring for automatically retracting the pricking element into the contact element after a pricking procedure has been completed and a locking mechanism for locking the pricking device after completion of a single pricking procedure and thereby preventing additional use of the pricking device.

Claims

1. A pricking device for withdrawing blood, comprising:

a contact element configured for contacting an extraction surface;

an actuating element configured for manually actuating the pricking device;

a pricking element which is displaceable relative to the contact element in a direction substantially perpendicular to the extraction surface, the pricking element being arranged in the contact element such that a defined pricking depth is obtained during the pricking procedure, the pricking element being positioned within the contact element before the pricking procedure is initiated;

a return spring configured to automatically retract the pricking element into the contact element after the pricking procedure has been completed; and

a locking mechanism configured to lock the pricking device after completion of a single pricking procedure, the locking mechanism comprising a bolt defined by one of the contact element and the actuating element and a switch defined by the other of the contact element and the actuating element, the bolt configured to slide along a first guide surface of the switch when the pricking procedure is initiated and then slide along a second guide surface of the switch when the pricking element is retracted by the return spring after completion of the pricking procedure.

2. The pricking device of claim 1, wherein the return spring is configured in a substantially unstressed state before the pricking procedure is initiated.

3. The pricking device of claim 1, further comprising a usage indicator for displaying whether the pricking device has been used.

4. The pricking device of claim 3, wherein the usage indicator is based upon the actuating element being arranged relative to the contact element differently before the pricking device is actuated than after the pricking device has been locked by the locking mechanism.

5. The pricking device of claim 1, wherein the pricking element comprises a needle, a lancet or a blade.

6. The pricking device of claim 1, further comprising a guide for guiding the pricking element while it is being displaced relative to the contact element.

7. The pricking device of claim 1, wherein a compression or an expansion of the return spring takes place during the pricking procedure.

8. The pricking device of claim 1, wherein the actuating element comprises a push-button with a push surface.

9. The pricking device of claim 1, wherein the locking mechanism comprises two locking mechanisms with identical actions arranged symmetrically with respect to the pricking element.

10. The pricking device of claim 9, wherein the contact element comprises two contact elements arranged symmetrically with respect to the pricking element, and the return spring comprises two return springs arranged symmetrically with respect to the pricking element.

11. The pricking device of claim 1, wherein the contact element is displaceably mounted in the actuating element or the actuating element is displaceably mounted in the contact element.

12. The pricking device of claim 1, wherein the pricking element is fixedly connected to the actuating element.

13. The pricking device of claim 12, wherein the pricking element is metal and is encapsulated by the actuating element, the actuating element being made of plastic.

14. The pricking device of claim 1, wherein the bolt is integrally formed with and extends from the contact element or the actuating element.

15. The pricking device of claim 1, wherein the bolt in the locked position engages a projection or a depression.

16. The pricking device of claim 1, further comprising a first limit stop contained in the actuating element and a second limit stop contained in the contact element, wherein the first and second limit stops interact when the defined pricking depth is reached.

17. The pricking device of claim 1, wherein the switch comprises a deflector fixedly connected to the contact element and the bolt comprises a hook fixedly connected to the actuating element.

18. The pricking device of claim 17, wherein the deflector is configured such that, before actuation and during displacement of the pricking element toward the extraction surface, the deflector maintains the hook spaced away from a depression in the contact element and guides the hook along the first guide surface, further wherein, after a pricking procedure has been completed, the hook is guided by the second guide surface into the depression, whereby the hook is then locked in the depression in the locked position.

19. The pricking device of claim 1, wherein the pricking device has a substantially flat design and is comprised of multiple layers.

20. The pricking device of claim 19, wherein the contact element, the actuating element, the pricking element, the return spring and the locking mechanism are all formed from a unitary metal strip.

21. The pricking device of claim 20, wherein the metal strip has a width of 10 mm to 50 mm and a thickness of 0.1 mm to 2 mm.

22. The pricking device of claim 20, wherein the metal strip is connected on both sides to at least one film strip.

23. The pricking device of claim 22, wherein the metal strip is connected on both sides to a plurality of mutually displaceable film strips.

24. The pricking device of claim 22, wherein the at least one film strip has a thickness of 50 μ

m to 2 mm.

25. The pricking device of claim 22, wherein the at least one film strip is connected to the metal strip by an adhesive.

26. The pricking device of claim 25, wherein the adhesive contains glass beads.

27. The pricking device of claim 22, wherein the at least one film strip is transparent.

28. The pricking device of claim 1, wherein the actuating element comprises a cylindrical sleeve which is closed at the top and which includes at least one lateral recess.

29. The pricking device of claim 28, wherein the contact element comprises a cylindrical member having a central longitudinal bore.

30. The pricking device of claim 28, wherein the return spring comprises a helical spring surrounding the pricking element, the return spring being supported on an inner, first annular surface of the actuating element and on an upper, second annular surface of the contact element.

31. The pricking device of claim 28, wherein the bolt comprises at least one guide block which is fixedly connected to the contact element by a spring element and which protrudes into the lateral recess of the actuating element.

32. The pricking device of claim 31, wherein the switch is fixedly connected to the actuating element and configured such that the guide block moves the switch from a rest position upon actuation of the pricking device, and the switch automatically moves back into the rest position after the guide block has passed the switch.

33. The pricking device of claim 32, further comprising a second switch fixedly connected to the actuating element, the guide block moving the second switch from a starting position during a movement of the pricking device and the second switch automatically returning to its starting position after the guide block has passed, wherein a locking of the guide block to the actuating element is achieved.

34. The pricking device as claimed in claim 33, wherein the second switch bears on an abutment.

35. A pricking device for withdrawing blood, comprising:

a contact element configured for contact with an extraction surface;

a pricking element for perforating the extraction surface; and

an actuating element configured for manually actuating the pricking device, the actuating element comprising a lever configured to turn about a hinge pin to move the pricking element; and

a holding element which secures the lever before actuation of the pricking device, wherein the lever requires a release force applied thereto to disengage the lever from the holding element.

36. The pricking device of claim 35, wherein the holding element is configured to break or buckle to disengage the lever when a force equal to or exceeding the release force is applied to the lever.

37. The pricking device of claim 35, wherein the lever comprises a distal end which engages the pricking element and a proximal end which is manually actuated.

38. The pricking device of claim 37, wherein, before the pricking device is actuated, the distal end of the lever rests on a contact surface of the pricking element, the pricking element being displaceable in a direction substantially perpendicular to the extraction surface, wherein manual actuation of the proximal end of the lever applies a force to the pricking element via the contact surface.

39. The pricking device of claim 37, wherein the distal end of the lever is fixedly connected to the pricking element, the pricking element comprising a blade.

40. The pricking device of claim 35, further comprising a locking mechanism for locking the pricking device after completion of a pricking procedure, the locking mechanism locking the lever in an end position.

41. The pricking device of claim 35, wherein the contact element comprises a housing with a recess, wherein a proximal end of the lever protrudes through the recess before the pricking device is actuated.

42. The pricking device of claim 41, wherein the proximal end of the lever retracts into the housing when the pricking device is actuated.

43. The pricking device of claim 35, wherein:

the pricking element comprises a return spring and a contact surface terminating in an edge;

the lever comprises a distal end configured to slide across the contact surface and a proximal end configured for manual actuation;

the contact element comprises a housing which houses the pricking element and the lever; and

further wherein, upon actuation of the proximal end of the lever, the distal end of the lever slides across the contact surface and advances the pricking element in a pricking direction until the distal end of the lever passes the edge, whereafter the return spring draws the pricking element completely into the housing and the distal end of the lever is positioned in a locked position in which it no longer applies a force to the pricking element in the pricking direction.

44. The pricking device of claim 43, wherein the distal end of the lever, in the locked position, is fixed between an inside wall of the housing and the pricking element.

45. The pricking device of claim 43, wherein the proximal end is positioned substantially within the housing in the locked position.

46. A method for producing a pricking device of the type comprising a contact element for contacting an extraction surface, an actuating element for actuating the pricking device, a displaceable pricking element, and a return spring configured to automatically retract the pricking element into the contact element after the pricking procedure has been completed, the method comprising forming the contact element, the actuating element, the pricking element, the return spring and the locking mechanism from a metal strip by micro-punching, laser cutting, etching, or a combination thereof.

47. The method of claim 46, further comprising forming the contact element and the actuating element integrally, wherein the contact element and actuating element are initially connected by a holding part, and then removing the holding part after the contact element and actuating element have been formed.

48. The method of claim 46, further comprising forming a plurality of contiguous pricking devices from the metal strip.

49. The method of claim 48, further comprising separating the individual pricking devices from one another by punching through connecting elements provided between them.

50. The method of claim 48, further comprising adhering a film strip to the single metal strip by adhesive or thermal bonding.

51. The method of claim 50, further comprising severing the film strip together with the metal strip by punching with straight cuts.

52. The method of claim 50, further comprising arranging two film strips on both sides of the metal strip, and welding the films over a recess in the metal strip.

53. A pricking device for withdrawing blood, comprising:

a contact element configured for contacting an extraction surface;

an actuating element configured for manually actuating the pricking device;

a pricking element which is displaceable relative to the contact element;

a return spring configured to automatically retract the pricking element into the contact element after the pricking procedure has been completed; and

wherein the contact element, the actuating element, the pricking element, and the return spring are formed from a single metal strip having a severed holding element that separates the contact element from the actuating element.

54. The pricking device of claim 53, further comprising a locking mechanism configured to lock the pricking device after completion of a single pricking procedure, the locking mechanism comprising a bolt and a switch, the bolt configured to slide along a first guide surface of the switch when the pricking procedure is initiated and then slide along a second guide surface of the switch when the pricking element is retracted by the return spring after completion of the pricking procedure.

55. The pricking device of claim 53, further comprising a first limit stop contained in the actuating element and a second limit stop contained in the contact element, wherein the first and second limit stops interact when the defined pricking depth is reached.

56. The pricking device of claim 53, wherein the metal strip is connected on both sides to at least one film strip.

57. The pricking device of claim 56, wherein the metal strip is connected on both sides to a plurality of mutually displaceable film strips.

58. The pricking device of claim 56, wherein the at least one film strip is connected to the metal strip by an adhesive containing beads.

59. The pricking device of claim 56, wherein the at least one film strip is transparent.

60. A pricking device for withdrawing blood, comprising:

a contact element configured for contacting an extraction surface;

an actuating element configured for manually actuating the pricking device;

a pricking element which is displaceable relative to the contact element;

a return spring configured to automatically retract the pricking element into the contact element after the pricking procedure has been completed; and

the contact element, the actuating element, the pricking element, and the return spring together forming an inner layer having opposite sides, each side having two films thereon that are displaceable relative to one another when the pricking device is actuated.

61. The pricking device of claim 60, wherein the two films comprise a cover film that is secured to the inner layer and a holding film that is displaceable relative to the cover film when the pricking device is actuated.

62. The pricking device of claim 61, further comprising a spacer film disposed on each side of the inner layer, each spacer film having one side adhered to the inner layer and its other side adhered to one of the holding films.

63. The pricking device of claim 62, wherein, on each side of the inner layer, the spacer film and the cover film are arranged in substantially the same plane.

64. The pricking device of claim 62, wherein the cover films maintain the contact element, actuating element, pricking element and return spring in a substantially planar orientation during use of the pricking device.

65. The pricking device of claim 62, further comprising a locking mechanism configured to lock the pricking device after completion of a single pricking procedure, the locking mechanism comprising a bolt and a switch, the bolt configured to slide along a first guide surface of the switch when the pricking procedure is initiated and then slide along a second guide surface of the switch when the pricking element is retracted by the return spring after completion of the pricking procedure.

66. The pricking device of claim 62, wherein at least one of the cover films is at least partially transparent.

67. The pricking device of claim 62, wherein the spacer film is adhered to the holding film and to the inner layer by an adhesive.

68. The pricking device of claim 62, wherein the inner layer comprises at least one recess on each side thereof, wherein the cover films or the spacer films are welded into the recesses.