Contact Activated Lancet Device

• US 20100305599A1
• Filed: 06/14/2010
• Published: 12/02/2010
• Est. Priority Date: 05/07/2004
• Status: Active Grant

• Current Assignee: Becton, Dickinson & Co
• Original Assignee: Becton, Dickinson & Co
• Inventors: Rutynowski, Wlodzinierz, Karbowniczek, Jacek Grzegorz, Wilkinson, Bradley M.
• Granted Patent: US 9,005,233 B2
• Time in Patent Office: Days
• US Class Current: 606/182
• CPC Class Codes: A61B 2017/00424 ergonomic, e.g. fitting in fist
• CPC Class Codes: A61B 5/1411 by percutaneous method, e.g. by lancet
• CPC Class Codes: A61B 5/150022 for capillary blood or interstitial fluid
• CPC Class Codes: A61B 5/150259 Improved gripping, e.g. with high friction pattern or projections on the housing surface or an ergonometric shape
• 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 5/150549 Protectors removed by rotational movement, e.g. torsion or screwing
• CPC Class Codes: A61B 5/150618 Integrally moulded protectors, e.g. protectors simultaneously moulded together with a further component, e.g. a hub, of the piercing element
• CPC Class Codes: A61B 5/150717 manually removed
• CPC Class Codes: A61B 5/150824 by visual feedback
• CPC Class Codes: A61B 5/15111 Semi-automatically triggered, e.g. at the end of the cocking procedure, for instance by biasing the main drive spring or when reaching sufficient contact pressure, the piercing device is automatically triggered without any deliberate action by the user
• CPC Class Codes: A61B 5/15117 comprising biased elements, resilient elements or a spring, e.g. a helical spring, leaf spring, or elastic strap
• CPC Class Codes: A61B 5/1513 comprising linear sliding guides 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

A lancet device including a housing and a lancet structure having a puncturing element. The lancet structure disposed within the housing and adapted for movement between a retaining or pre-actuated position wherein the puncturing element is retained within the housing, and a puncturing position wherein the puncturing element extends through a forward end of the housing. The lancet device includes a drive spring disposed within the housing for biasing the lancet structure toward the puncturing position, and a retaining hub retaining the lancet structure in the retracted position against the bias of the drive spring. The retaining hub includes a pivotal lever in interference engagement with the lancet structure. An actuator within the housing pivots the lever, thereby moving the lancet structure toward the rearward end of the housing to at least partially compress the drive spring, and releasing the lever from interference engagement with the lancet structure.

Claims

1. A lancet device comprising:

a housing;

a lancet structure comprising a puncturing element, the lancet structure disposed within the housing and adapted for movement between a pre-actuated position wherein the puncturing element is retained within the housing and a puncturing position wherein the puncturing element extends through a forward end of the housing;

a drive spring biasing the lancet structure toward the puncturing position;

a retaining hub retaining the lancet structure in the pre-actuated position against the bias of the drive spring, the retaining hub comprising a lever pivotal about a fulcrum, the lever providing interference engagement with the lancet structure; and

an actuator adapted to pivot the lever about the fulcrum, thereby releasing the lever from interference engagement with the lancet structure, permitting the drive spring to drive the lancet structure toward the puncturing position.

2. The lancet device of claim 1, wherein the actuator comprises an actuation element extending through and into the housing, wherein movement of the actuation element with respect to the housing causes the actuation element to pivot the lever about the fulcrum.

3. The lancet device of claim 2, wherein the actuation element extends through a rearward end of the housing and is movable with respect to the housing to cause the actuation element to pivot the lever about the fulcrum.

4. The lancet device of claim 1, wherein the actuator comprises an internal contact integrally formed within the housing, wherein movement of the housing toward the retaining hub causes the internal contact within the housing to pivot the lever about the fulcrum.

5. The lancet device of claim 4, further comprising a shield extending through the forward end of the housing and movable with respect to the housing, with the retaining hub adjacent a rearward end of the shield.

6. The lancet device of claim 5, wherein the lancet structure is retained by the retaining hub at the rearward end of the shield, and wherein movement of the rearward end of the shield toward the rearward end of the housing causes the actuator to pivot the lever of the retaining hub.

7. The lancet device of claim 5, wherein the lancet structure and the shield include corresponding guiding surfaces for guiding the lancet structure through the shield.

8. The lancet device of claim 5, wherein the shield and the housing include corresponding guiding surfaces for guiding the shield through the housing.

9. The lancet device of claim 5, further comprising a retraction spring for retracting the lancet structure within the shield after the drive spring drives the lancet structure through the shield toward the puncturing position.

10. The lancet device of claim 5, further comprising a locking structure extending between the shield and the housing for maintaining the shield in fixed relation to the housing after the drive spring drives the lancet structure through the shield toward the puncturing position.

11. The lancet device of claim 1, wherein the lever comprises a class 1 lever.

12. The lancet device of claim 11, wherein the lever comprises a shoulder in interference engagement with the lancet structure and a contact surface for engagement with the internal contact of the housing.

13. The lancet device of claim 12, wherein the lever comprises a wedge pivotally hinged to the retaining hub forming a pivot hinge defining the fulcrum for cooperative pivoting of the shoulder and the contact surface.

14. The lancet device of claim 13, wherein the retaining hub comprises an annular rim with the lever pivotally hinged to the annular rim.

15. The lancet device of claim 14, wherein the retaining hub comprises a pair of levers supported on opposing sides of the annular rim.

16. The lancet device of claim 12, wherein the lancet structure further comprises a carrier element including a finger in interference engagement with the shoulder of the lever.

17. A lancet device comprising:

a housing having a rearward end and a forward end having an opening extending therethrough;

a shield movable through the opening of the forward end of the housing, the shield comprising a retaining hub adjacent a rearward end thereof, the retaining hub comprising a pivotal lever;

a lancet structure comprising a puncturing element, the lancet structure disposed within the housing and adapted for movement between a pre-actuation position wherein the puncturing element is disposed within the housing and a puncturing position, wherein the puncturing element extends through a forward end of the shield, and the lancet structure is in interference engagement with the lever of the retaining hub at the rearward end of the shield thereby maintaining the lancet structure in the retracted position; and

a drive spring disposed between the housing and the lancet structure for biasing the lancet structure against the lever of the retaining hub,

wherein movement of the shield toward the rearward end of the housing causes an internal contact within the housing to engage the lever of the retaining hub, thereby causing pivotal movement of the lever to release the lancet structure from interference engagement with the lever, permitting the drive spring to drive the lancet structure through the shield toward the puncturing position.

18. The lancet device of claim 17, wherein the retaining hub comprises an annular rim separate from and retained at the rearward end of the shield.

19. The lancet device of claim 17, wherein the retaining hub comprises an annular rim with the lever pivotally supported on the annular rim.

20. The lancet device of claim 19, wherein the annular rim comprises a pair of levers pivotally supported on opposing sides of the annular rim.

21. The lancet device of claim 17, wherein the lever comprises a class 1 lever.

22. The lancet device of claim 21, wherein the lever comprises a shoulder in interference engagement with the lancet structure and a contact surface, such that engagement of the internal contact of the housing with the contact surface of the lever causes the lever to pivot, thereby releasing the lancet structure from interference engagement with the shoulder.

23. The lancet device of claim 22, wherein the internal contact of the housing comprises an integrally formed cam surface for cooperative engagement with the contact surface of the lever.

24. The lancet device of claim 22, wherein the lever comprises a wedge pivotally hinged to the retaining hub forming a pivot hinge for cooperative pivoting of the shoulder and the contact surface.

25. The lancet device of claim 24, wherein the retaining hub comprises an annular rim with the lever pivotally hinged to the annular rim.

26. The lancet device of claim 22, wherein the lancet structure further comprises a carrier element including a finger in interference engagement with the shoulder of the lever.

27. The lancet device of claim 17, wherein the lancet structure and the shield include corresponding guiding surfaces for guiding the lancet structure through the shield.

28. The lancet device of claim 27, wherein the lancet structure includes at least one guide tab on an external surface thereof and the shield includes at least one corresponding guide channel on an internal channel thereof for guiding movement of the lancet structure within the shield.

29. The lancet device of claim 17, wherein the shield and the housing include corresponding guiding surfaces for guiding the shield through the housing.

30. The lancet device of claim 29, wherein the shield includes at least one guide channel on an external surface thereof and the housing includes at least one corresponding guide tab therein for guiding movement of the shield within the housing.

31. The lancet device of claim 17, further comprising a retraction spring for retracting the lancet structure within the shield after the drive spring drives the lancet structure through the shield toward the puncturing position.

32. The lancet device of claim 31, wherein the retraction spring comprises a compression spring positioned within the forward end of the shield for compression between the lancet structure and the forward end of the shield, wherein the biasing force of the compression spring between the forward end of the shield and the lancet structure exceeds the biasing force of the drive spring between the rearward end of the housing and the lancet structure after the drive spring drives the lancet device to the puncturing position, thereby maintaining the puncturing element within the shield.

33. The lancet device of claim 17, further comprising a locking structure extending between the shield and the housing for maintaining the shield in fixed relation to the housing after the drive spring drives the lancet structure through the shield toward the puncturing position.

34. The lancet device of claim 33, wherein the locking structure comprises a frictional engagement between the shield and the housing.

35. The lancet device of claim 33, wherein the shield includes at least one locking finger adjacent the rearward end thereof for locking within a corresponding recess within the housing.

36. The lancet device of claim 17, wherein the housing comprises a main housing element and a rearward cap element.

37. The lancet device of claim 36, wherein the internal contact comprises a cam surface integrally formed within the rearward cap element.

38. The lancet device of claim 17, further comprising a lancet cover removably covering the puncturing element of the lancet structure and extending through the forward end of the shield.

39. The lancet device of claim 38, wherein the lancet cover comprises a post portion substantially enclosing the puncturing element and a forward tab adapted to be grasped by a user.

40. The lancet device of claim 17, wherein the puncturing element includes an alignment orientation, and at least one of the housing or the shield includes target indicia corresponding to the alignment orientation of the puncturing element.

41. A lancet device comprising a housing and a lancet including a puncturing element movable within the housing and retained within the housing against a bias of a drive spring biasing the lancet toward a puncturing position wherein the puncturing element extends through a forward end of the housing, the improvement comprising an annular retaining hub comprising at least one lever in interference engagement with the lancet for retaining the lancet within the housing against the bias of the drive spring, the lever being pivotal about a fulcrum on one side of a plane dissecting the annular retaining hub at a cross-section to an axis defined by the lancet, wherein pivoting of the lever about the fulcrum releases the lancet from interference engagement with the lever to permit the drive spring to drive the lancet toward the puncturing position.

42. The lancet device of claim 41, wherein movement of the housing and the annular retaining hub with respect to each other causes an internal contact within the housing to pivot the lever about the fulcrum.

43. The lancet device of claim 42, further comprising a shield extending through a forward end of the housing and moveable with respect to the housing, the annular retaining hub adjacent a rearward end of the shield, at least a portion of the lancet being moveable through the shield and the annular retaining hub upon release of the lancet from interference engagement with the lever.

44. The lancet device of claim 41, further comprising an actuator having an actuation element extending through and into the housing, wherein movement of the actuation element with respect to the housing causes the actuation element to pivot the lever about the fulcrum.

45. The lancet device of claim 44, wherein the actuation element extends through a rearward end of the housing and is movable with respect to the housing to cause the actuation element to pivot the lever about the fulcrum.

46. A method of retaining a lancet structure in a pre-activated position within a housing, comprising:

providing the lancet structure with a puncturing element disposed within the housing; and

retaining the puncturing element within the housing against a bias of a drive spring biasing the lancet structure toward a puncturing position in which the puncturing element extends through a forward end of the housing, the improvement comprising retaining the lancet within the housing against the bias of the drive spring with a retaining hub comprising a rim including a lever in interference engagement with the lancet structure, the lever being pivotal about a fulcrum.

47. The method of claim 46, wherein movement of the housing and the retaining hub with respect to each other causes a contact within the housing to pivot the lever about the fulcrum, thereby moving the lancet structure toward the rearward end of the housing to at least partially compress the drive spring and release the lever from interference engagement with the lancet structure, permitting the drive spring to drive the lancet structure through the housing toward the puncturing position.

48. A method of actuating a lancet device comprising:

providing a lancet device comprising;

a housing;

a lancet structure disposed within the housing and including a puncturing element retained within the housing;

a drive spring biasing the lancet structure toward a puncturing position in which the puncturing element extends through a forward end of the housing; and

a retaining hub retaining the lancet structure within the housing against a bias of the drive spring, the retaining hub comprising a pivotal lever in interference engagement with the lancet structure; and

contacting the lever with an actuator to pivot the lever, thereby sequentially causing the lancet structure to move toward a rearward end of the housing to compress the drive spring and release the interference engagement between the lever and the lancet structure, thereby causing the drive spring to drive the lancet structure toward the puncturing position.

49. The method of claim 48, wherein the actuator comprises an internal contact within the housing, and wherein the contacting step comprises displacing the housing and the retaining hub toward each other to cause the internal contact of the housing to pivot the lever.

50. The method of claim 49, wherein the lancet device further comprises a shield extending through the forward end of the housing and movable with respect to the housing, with the retaining hub adjacent the rearward end of the shield retaining the lancet structure within the housing against the bias of the drive spring.

51. The method of claim 50, comprising a displacement step involving displacing the rearward end of the shield and the rearward end of the housing toward each other to cause the contacting step.

52. The method of claim 51, wherein the displacement step comprises applying external pressure between a forward end of the shield and the rearward end of the housing.

53. The method of claim 50, wherein the lever comprises a shoulder in interference engagement with the lancet structure and a contact surface for engagement with the internal contact of the housing, and wherein the contacting step comprises engaging the internal contact of the housing with the contact surface of the lever to pivot the lever.

54. The method of claim 53, wherein the retaining hub comprises an annular rim with the lever pivotally hinged to the annular rim such that the shoulder extends radially inward of the annular rim and the contact surface is at an external perimeter of the annular rim, and wherein the contacting step comprises engaging the internal contact of the housing with the contact surface of the lever at an external perimeter of the annular rim, thereby pivoting the lever by tipping the contact surface and the shoulder to release the lancet structure through the annular rim and through the shield.

55. The method of claim 50, wherein the method further comprises a step of retracting the puncturing element within the housing after the puncturing element reaches the puncturing position.

56. The method of claim 50, wherein the lancet device further comprises a compression spring positioned within the forward end of the shield, and wherein the retraction step comprises compressing the compression spring between the lancet structure and the forward end of the shield through the bias of the drive spring and thereafter relaxing the compression spring, wherein the biasing force of the compression spring between the forward end of the shield and the lancet structure in a relaxed state exceeds the biasing force of the drive spring between the rearward end of the housing and the lancet structure after the drive spring drives the lancet device to the puncturing position, thereby retracting the puncturing element within the shield and maintaining the lancet structure within the housing.

57. A lancet device comprising:

a housing;

a lancet comprising a puncturing element axially movable within the housing and retained within the housing, the lancet movable toward a puncturing position wherein the puncturing element extends through a forward end of the housing;

a shield extending through a forward end of the housing and moveable with respect to the housing; and

an annular retaining hub comprising at least one class 1-type lever being pivotal about a fulcrum, the lever having a first position with respect to the fulcrum wherein the hub restricts movement of the lancet with respect to the shield, and a second position with respect to the fulcrum wherein the hub does not restrict movement of the lancet with respect to the shield, the second position enabling the lancet to achieve a puncture position through the forward end of the shield,

wherein movement of the shield with respect to the housing causes movement of the lever from the first position to the second position, thereby releasing the lancet from interference engagement with the lever.

58. The lancet device of claim 57, comprising a drive spring having one end engaged to either the shield or the housing and the other end engaged to the lancet, wherein sufficient pivotal movement of the class 1-type lever permits the drive spring to drive the lancet toward the puncturing position.

59. A lancet device comprising:

a housing;

a lancet structure comprising a puncturing element, the lancet structure disposed within the housing and adapted for movement between a pre-actuated position and a puncturing position wherein the puncturing element extends through an end of the housing;

a biasing member for biasing the lancet structure toward the puncturing position;

a retaining hub retaining the lancet structure in the pre-actuated position against the bias of the drive spring, the retaining hub comprising a lever, the lever providing interference engagement with the lancet structure; and

an actuator adapted to pivot the lever thereby releasing the lever from interference engagement with the lancet structure, permitting the biasing member to drive the lancet structure toward the puncturing position.

60. The lancet device of claim 59, wherein the actuator comprises an actuation element extending through and into the housing, wherein movement of the actuation element with respect to the housing causes the actuation element to pivot the lever.

61. The lancet device of claim 59, further comprising a shield extending through the forward end of the housing and movable with respect to the housing, with the retaining hub adjacent a rearward end of the shield and wherein the lancet structure is retained by the retaining hub at the rearward end of the shield such that movement of the rearward end of the shield toward the rearward end of the housing causes the actuator to pivot the lever of the retaining hub.

62. The lancet device as in claim 59, wherein the lever comprises a class 1 lever.

63. The lancet device of claim 59, wherein the lever comprises a shoulder in interference engagement with the lancet structure and a contact surface for engagement with the internal contact of the housing.

64. The lancet device of claim 63, wherein the lever comprises a wedge pivotally hinged to the retaining hub forming a pivot hinge defining a fulcrum for cooperative pivoting of the shoulder and the contact surface.

65. The lancet device of claim 59, wherein the retaining hub comprises an annular rim with the lever comprising a pair of levers supported on opposing sides of the annular rim and pivotally hinged to the annular rim.

66. A lancet device comprising:

a housing having a rearward end and a forward end having an opening extending therethrough;

a shield movable through the opening of the forward end of the housing, the shield comprising a retaining hub adjacent a rearward end thereof, the retaining hub comprising a pivotal lever;

a lancet structure comprising a puncturing element, the lancet structure disposed within the housing and adapted for movement between a pre-actuation position wherein the puncturing element is disposed within the housing and a puncturing position wherein the puncturing element extends through a forward end of the shield, and the lancet structure is in interference engagement with the lever of the retaining hub thereby maintaining the lancet structure in the retracted position; and

a biasing member in cooperation with the lancet structure for biasing the lancet structure against the lever of the retaining hub,

wherein movement of the shield causes pivotal movement of the lever to release the lancet structure from interference engagement with the lever, permitting the biasing member to drive the lancet structure through the shield toward the puncturing position.

67. The lancet device of claim 66, wherein the retaining hub comprises an annular rim separate from and retained at the rearward end of the shield and includes a pair of levers pivotally supported on opposing sides of the annular rim.

68. The lancet device of claim 66, wherein the lever comprises a class 1 lever.

69. The lancet device of claim 66, wherein the lancet structure further comprises a carrier element including a finger in interference engagement with a shoulder of the lever.

70. The lancet device of claim 66, wherein the lancet structure and the shield include corresponding guiding surfaces for guiding the lancet structure through the shield.

71. The lancet device of claim 66, wherein the shield and the housing include corresponding guiding surfaces for guiding the shield through the housing.

72. The lancet device of claim 66, further comprising a retraction spring and wherein the retraction spring comprises a compression spring positioned within the forward end of the shield for compression between the lancet structure and the forward end of the shield, wherein the biasing force of the compression spring between the forward end of the shield and the lancet structure exceeds the biasing force of the biasing member between the rearward end of the housing and the lancet structure after the biasing member drives the lancet device to the puncturing position, thereby maintaining the puncturing element within the shield.

73. The lancet device of claim 66, wherein the shield includes at least one locking finger adjacent the rearward end thereof for locking within a corresponding recess within the housing for maintaining the shield in fixed relation to the housing after the biasing member drives the lancet structure through the shield toward the puncturing position.

74. The lancet device of claim 66, wherein the housing comprises a main housing element and a rearward cap element and wherein the internal contact comprises a cam surface integrally formed within the rearward cap element.

75. The lancet device of claim 66, further comprising a lancet cover removably covering the puncturing element of the lancet structure and extending through the forward end of the shield.

76. The lancet device of claim 66, wherein the puncturing element includes an alignment orientation, and at least one of the housing or the shield includes target indicia corresponding to the alignment orientation of the puncturing element.

77. A method of retaining a lancet structure in a pre-activated position within a housing, comprising:

providing the lancet structure with a puncturing element disposed within the housing; and

retaining the puncturing element within the housing against a bias of a biasing member biasing the lancet structure toward a puncturing position in which the puncturing element extends through an end of the housing, the improvement comprising retaining the lancet within the housing against the bias of the biasing member with a retaining hub comprising a rim including a lever in interference engagement with the lancet structure, the lever being pivotal about a pivot point, wherein movement of the housing and the retaining hub with respect to each other causes the lever to pivot about the pivot point to at least partially compress the biasing member and release the lever from interference engagement with the lancet structure, permitting the biasing member to drive the lancet structure through the housing toward the puncturing position.

78. A method of actuating a lancet device comprising:

providing a lancet device comprising;

a housing;

a lancet structure disposed within the housing and including a puncturing element retained within the housing;

a biasing member biasing the lancet structure toward a puncturing position in which the puncturing element extends through an end of the housing; and

a retaining hub retaining the lancet structure within the housing against a bias of the biasing member, the retaining hub comprising a pivotal lever in interference engagement with the lancet structure; and

contacting the lever with an actuator to pivot the lever, causing a release of the interference engagement between the lever and the lancet structure, thereby causing the biasing member to drive the lancet structure toward the puncturing position.

79. The method of claim 78, wherein the actuator comprises an internal contact within the housing, and wherein the contacting step comprises displacing the housing and the retaining hub toward each other to cause the internal contact of the housing to pivot the lever.

80. The method of claim 79, wherein the lancet device further comprises a shield extending through the forward end of the housing and movable with respect to the housing, with the retaining hub adjacent the rearward end of the shield retaining the lancet structure within the housing against the bias of the biasing member.

81. The method of claim 80, further comprising a displacement step involving displacing the rearward end of the shield and the rearward end of the housing toward each other to cause the contacting step.

82. The method of claim 81, wherein the lever comprises a shoulder and the retaining hub comprises an annular rim with the lever pivotally hinged to the annular rim such that the shoulder extends radially inward of the annular rim and the contact surface is at an external perimeter of the annular rim, and wherein the contacting step comprises engaging the internal contact of the housing with the contact surface of the lever at an external perimeter of the annular rim, thereby pivoting the lever by tipping the contact surface and the shoulder to release the lancet structure through the annular rim and through the shield.

83. The method of claim 78, wherein the method further comprises providing a compression spring for retracting the puncturing element within the housing after the puncturing element reaches the puncturing position.

84. A lancet device comprising:

a housing;

a lancet comprising a puncturing element axially movable within the housing and retained within the housing, the lancet movable toward a puncturing position wherein the puncturing element extends through a forward end of the housing;

a shield extending through a forward end of the housing and moveable with respect to the housing; and

an annular retaining hub comprising at least one lever being pivotal about a pivot point, the lever having a first position with respect to the pivot point wherein the hub restricts movement of the lancet with respect to the shield, and a second position with respect to the pivot point wherein the hub does not restrict movement of the lancet with respect to the shield, the second position enabling the lancet to achieve a puncture position through the forward end of the shield,

wherein movement of the shield with respect to the housing causes movement of the lever from the first position to the second position, thereby releasing the lancet from interference engagement with the lever.

85. The lancet device of claim 84, comprising a biasing member having one end engaged to either the shield or the housing and the other end engaged to the lancet, wherein sufficient pivotal movement of the lever permits the biasing member to drive the lancet toward the puncturing position.