Contact activated lancet device

• US 9,005,233 B2
• Filed: 06/14/2010
• Issued: 04/14/2015
• Est. Priority Date: 05/07/2004
• Status: Active Grant

• Current Assignee: Becton, Dickinson & Co
• Original Assignee: Becton, Dickinson & Co
• Inventors: Rutynowski, Wlodzinierz, Wilkinson, Bradley M., Karbowniczek, Jarek Grzegorz
• Primary Examiner(s): Houston, Elizabeth
• Assistant Examiner(s): LYNCH, ROBERT A
• Application Number:
  US12/815,005
• Publication Number:
  US 20100305599A1
• Time in Patent Office: 1,765 Days
• Field of Search: 606181-183, 606/185, 604/157, 604134-138, D24/146, D24/147, 600/583
• 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 comprising a class 1 lever, the lever providing interference engagement with the lancet structure, the lever comprising a first lever element and a second lever element spaced from the first lever element, the first lever element and the second lever element disposed on opposing sides of 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 shoulder in interference engagement with the lancet structure and a contact surface for engagement with an internal contact of the housing.

12. The lancet device of claim 11, 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.

13. The lancet device of claim 12, wherein the retaining hub comprises an annular rim with the lever pivotally hinged to the annular rim.

14. The lancet device of claim 11, wherein the lancet structure further comprises a carrier element including a finger in interference engagement with the shoulder of the lever.

15. 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 pivotal about a fulcrum, the lever comprising a class 1 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.

16. The lancet device of claim 15, wherein the retaining hub comprises an annular rim separate from and retained at the rearward end of the shield.

17. The lancet device of claim 15, wherein the retaining hub comprises an annular rim with the lever pivotally supported on the annular rim.

18. The lancet device of claim 17, wherein the annular rim comprises a pair of levers pivotally supported on opposing sides of the annular rim.

19. The lancet device of claim 15, 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.

20. The lancet device of claim 19, wherein the internal contact of the housing comprises an integrally formed cam surface for cooperative engagement with the contact surface of the lever.

21. The lancet device of claim 19, 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.

22. The lancet device of claim 21, wherein the retaining hub comprises an annular rim with the lever pivotally hinged to the annular rim.

23. The lancet device of claim 19, wherein the lancet structure further comprises a carrier element including a finger in interference engagement with the shoulder of the lever.

24. The lancet device of claim 15, wherein the lancet structure and the shield include corresponding guiding surfaces for guiding the lancet structure through the shield.

25. The lancet device of claim 24, 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.

26. The lancet device of claim 15, wherein the shield and the housing include corresponding guiding surfaces for guiding the shield through the housing.

27. The lancet device of claim 26, 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.

28. The lancet device of claim 15, 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.

29. The lancet device of claim 28, 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.

30. The lancet device of claim 15, 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.

31. The lancet device of claim 30, wherein the locking structure comprises a frictional engagement between the shield and the housing.

32. The lancet device of claim 30, wherein the shield includes at least one locking finger adjacent the rearward end thereof for locking within a corresponding recess within the housing.

33. The lancet device of claim 15, wherein the housing comprises a main housing element and a rearward cap element.

34. The lancet device of claim 33, wherein the internal contact comprises a cam surface integrally formed within the rearward cap element.

35. The lancet device of claim 15, further comprising a lancet cover removably covering the puncturing element of the lancet structure and extending through the forward end of the shield.

36. The lancet device of claim 35, wherein the lancet cover comprises a post portion substantially enclosing the puncturing element and a forward tab adapted to be grasped by a user.

37. The lancet device of claim 15, 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.

38. 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, comprising an annular retaining hub comprising a lever in interference engagement with the lancet for retaining the lancet within the housing against the bias of the drive spring, the lever comprising a class 1 lever, 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, the lever comprising a first lever element and a second lever element spaced from the first lever element, the first lever element and the second lever element disposed on opposite sides of the lancet, wherein pivoting of the lever about the fulcrum upon engagement of the lever with a portion of the housing releases the lancet from interference engagement with the lever to permit the drive spring to drive the lancet toward the puncturing position.

39. The lancet device of claim 38, 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.

40. The lancet device of claim 39, 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.

41. The lancet device of claim 38, 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.

42. The lancet device of claim 41, 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.

43. 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 drive spring biasing the lancet toward the puncturing position;

a shield extending through the 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, and

wherein the drive spring has one end engaged to either the shield or the housing and the other end engaged to the lancet, wherein sufficient pivotal movement of the at least one class 1-type lever permits the drive spring to drive the lancet toward the puncturing position.

44. 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 drive spring 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 pivotal about a fulcrum, the lever comprising a class 1 lever, the lever providing interference engagement with the lancet structure, the lever comprising a first lever element and a second lever element spaced from the first lever element, the first lever element and the second lever element disposed on opposing sides of the lancet structure; and

an actuator adapted to pivot the lever upon engagement of the lever with a portion of the housing thereby releasing the lever from interference engagement with the lancet structure, permitting the drive spring to drive the lancet structure toward the puncturing position.

45. The lancet device of claim 44, 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.

46. The lancet device of claim 44, 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.

47. The lancet device of claim 44, 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.

48. The lancet device of claim 47, 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.

49. 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 pivotal about a fulcrum, the lever comprising a class 1 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 upon engagement of the lever with a portion of the housing 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.

50. The lancet device of claim 49, 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.

51. The lancet device of claim 49, wherein the lancet structure further comprises a carrier element including a finger in interference engagement with a shoulder of the lever.

52. The lancet device of claim 49, wherein the lancet structure and the shield include corresponding guiding surfaces for guiding the lancet structure through the shield.

53. The lancet device of claim 49, wherein the shield and the housing include corresponding guiding surfaces for guiding the shield through the housing.

54. The lancet device of claim 49, 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.

55. The lancet device of claim 49, 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.

56. The lancet device of claim 49, 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.

57. The lancet device of claim 49, further comprising a lancet cover removably covering the puncturing element of the lancet structure and extending through the forward end of the shield.

58. The lancet device of claim 49, 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.

59. 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 the forward end of the housing and moveable with respect to the housing; and

an annular retaining hub comprising a lever pivotal about a pivot point upon engagement of the lever with a portion of the housing, the lever comprising a class 1 lever, 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, the lever comprising a first lever element and a second lever element spaced from the first lever element, the first lever element and the second lever element disposed on opposing sides of the lancet,

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.

60. The lancet device of claim 59, 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.