Disposable or single-use lancet device and method

• US 8,066,728 B2
• Filed: 11/30/2004
• Issued: 11/29/2011
• Est. Priority Date: 11/30/2004
• Status: Active Grant

• Current Assignee: Stat Medical Devices Incorporated
• Original Assignee: Stat Medical Devices Incorporated
• Inventors: Schraga, Steven
• Primary Examiner(s): NGUYEN, TUAN VAN
• Application Number:
  US10/998,636
• Publication Number:
  US 20060116705A1
• Time in Patent Office: 2,555 Days
• Field of Search: 606/182, 606/181, 600/583, 600/584
• US Class Current: 606/182
• 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 5/150618 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 5/150908 by disconnecting components, e.g. breaking or rupturing of connected parts, e.g. piston and rod
• 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 5/15144 comprising driving means, e.g. a spring, for retracting the piercing unit into the housing

Abstract

Single-use lancet device includes a body. A movable skin engaging member is at least partially disposed inside the body and includes a lancet opening through which a lancet needle extends. A holding member can move at least between a retracted position and an extended position. The skin engaging member is structured and arranged to retract into the body. This Abstract is not intended to define the invention disclosed in the specification, nor intended to limit the scope of the invention in any way.

Claims

1. A single-use lancet device, comprising:

a body;

a skin engaging member being movable with respect to the body and comprising a lancet opening through which a lancet needle extends;

a holding member movably mounted within the body and comprising a front end and a rear end;

the holding member being movable at least between a retracted position and an extended position;

a first stop surface that moves with the skin engaging member; and

a second stop surface that moves with the holding member,

wherein movement of the skin engaging member from an initial position to a triggering position causes the holding member to move towards the extended position,

wherein, once caused to move to the extended position, the holding member is prevented from moving back to the retracted position, and

wherein after a triggering of the lancet device, the skin engaging member is caused to automatically move towards a retracted position and thereby prevent reuse of the single-use lancet device.

2. The lancet device of claim 1, further comprising a spring, wherein the spring causes the holding member to move to the extended position and prevents the holding member from moving back to the retracted position.

3. The lancet device of claim 2, wherein the spring causes the skin engaging member to move to a retracted position, whereby the skin engaging member is disposed within the body.

4. The lancet device of claim 1, further comprising a spring which causes the skin engaging member and the holding member to move into the body after the lancet device is triggered.

5. The lancet device of claim 1, further comprising a spring which causes movement of the holding member between the retracted position and the extended position and between the extended position and an intermediate position.

6. The lancet device of claim 1, further comprising a spring which causes the holding member to move away from the lancet opening after the lancet device is triggered.

7. The lancet device of claim 6, wherein the holding member causes the skin engaging member to move into the body after the lancet device is triggered.

8. The lancet device of claim 1, wherein the holding member causes the skin engaging member to move into the body after the lancet device is triggered.

9. The lancet device of claim 1, further comprising a compression spring for biasing the holding member towards the extended position.

10. The lancet device of claim 9, wherein the compression spring comprises one end that is fixed to the rear end of the holding member and another end that is fixed to the body.

11. The lancet device of claim 9, wherein the compression spring comprises one end that is connected to the holding member and another end that is connected to the body.

12. The lancet device of claim 1, wherein the lancet device is automatically triggered by movement of the skin engaging portion.

13. The lancet device of claim 1, wherein the body comprises an upper housing part and a lower housing part.

14. The lancet device of claim 13, wherein the upper housing part comprises a cover and the lower housing part comprises a main body portion.

15. The lancet device of claim 1, wherein the holding member comprises the lancet needle and at least one deflectable arm.

16. The lancet device of claim 1, wherein the holding member comprises at least one integrally formed deflectable arm.

17. The lancet device of claim 1, wherein the holding member comprises two oppositely arranged integrally formed deflectable arms.

18. The lancet device of claim 1, wherein the holding member comprises a mechanism for releasably engaging with at least one flange fixed inside the body.

19. The lancet device of claim 1, wherein the holding member comprises two mechanisms for releasably engaging with two flanges fixed inside the body.

20. The lancet device of claim 19, wherein the holding member comprises two oppositely arranged integrally formed deflectable arms.

21. The lancet device of claim 20, wherein one of the two mechanisms is arranged on one of the two integrally formed deflectable arms and another of the two mechanisms is arranged on another of the two integrally formed deflectable arms.

22. The lancet device of claim 1, wherein the holding member comprises two mechanisms for releasably engaging with two projections fixed inside the body.

23. The lancet device of claim 22, wherein the holding member comprises two oppositely arranged deflectable arms.

24. The lancet device of claim 23, wherein one of the two mechanisms is arranged on one of the two deflectable arms and another of the two mechanisms is arranged on another of the two deflectable arms.

25. The lancet device of claim 1, wherein the holding member comprises two oppositely arranged deflectable arms, each deflectable arm comprising two projections and a space disposed between the two projections, whereby each space receives therein a projecting portion fixed within the body when the holding member is in the retracted position.

26. The lancet device of claim 1, wherein the holding member comprises a removable tab portion.

27. The lancet device of claim 1, wherein the holding member comprises a mechanism for preventing accidental triggering of the lancet device.

28. The lancet device of claim 27, wherein the mechanism for preventing accidental triggering of the lancet device comprises a removable tab portion coupled to the front end of the holding member.

29. The lancet device of claim 1, wherein the front end of the holding member holds the lancet needle.

30. The lancet device of claim 1, wherein the lancet needle projects from the front end of the holding member.

31. The lancet device of claim 1, wherein the second stop surface is arranged on the front end of the holding member and behind a tip of the lancet needle.

32. The lancet device of claim 1, further comprising a removable trigger preventing device, whereby the lancet device cannot be triggered without removing the trigger preventing device.

33. The lancet device of claim 1, further comprising a removable trigger preventing device, whereby the lancet device cannot be triggered or used without disconnecting the trigger preventing device from the front end of the holding member.

34. The lancet device of claim 33, wherein the removable trigger preventing device comprises a gripping portion, a flange which engages the skin engaging member, and an end adapted to cover the lancet needle.

35. The lancet device of claim 34, wherein the removable trigger preventing device comprises a gripping portion, a flange which engages the skin engaging member, and an end removably connected to the front of the holding member and adapted to cover the lancet needle.

36. The lancet device of claim 1, wherein the skin engaging member is configured to slide into the body during triggering of the lancet device.

37. The lancet device of claim 1, wherein the skin engaging member comprises at least one straight and/or planar surface which slidably engages at least one straight and/or planar surface of the body during triggering of the lancet device.

38. The lancet device of claim 1, wherein the skin engaging member comprises a generally rectangular cross-sectional shape.

39. The lancet device of claim 1, wherein an inside surface of the skin engaging member comprises the first stop surface.

40. The lancet device of claim 1, wherein the body comprises a mechanism for guiding an axial movement of the holding member.

41. The lancet device of claim 40, wherein the mechanism for guiding comprises at least two projecting flanges arranged inside the body.

42. The lancet device of claim 41, wherein the holding member comprises at least one projecting portion which moves with a space disposed between the at least two projecting flanges.

43. The lancet device of claim 40, wherein the mechanism for guiding comprises oppositely arranged projecting flanges arranged inside the body.

44. The lancet device of claim 43, wherein the holding member comprises two oppositely arranged projecting portions which move with spaces disposed between the oppositely arranged projecting flanges.

45. The lancet device of claim 40, wherein the holding member comprises ends which engage internal shoulders of the skin engaging member when the holding member moves from the extended position to an intermediate position.

46. The lancet device of claim 1, wherein the body comprises a two-piece body.

47. The lancet device of claim 1, wherein the skin engaging member comprises at least one recess which receives therein a projection extending into the body.

48. The lancet device of claim 1, wherein the skin engaging member comprises oppositely arranged recesses which each receive therein a projection fixed to the body.

49. A method of puncturing a surface of skin using the lancet device of claim 1, the method comprising:

disposing the skin engaging member of the lancet device against a user'"'"'s skin;

moving the skin engaging portion relative to the body so as to cause automatic triggering of the lancet device, whereby the lancet needle is caused to penetrate the user'"'"'s skin; and

preventing the user from moving the holding member to the retracted position.

50. A method of puncturing a surface of skin using the lancet device of claim 1, the method comprising:

disposing the skin engaging member of the lancet device against a user'"'"'s skin;

moving the skin engaging portion relative to the body so as to cause automatic triggering of the lancet device, whereby the lancet needle is caused to penetrate the user'"'"'s skin;

preventing the user from moving the holding member to the retracted position; and

preventing the user from moving the skin engaging member to the initial position.

51. A method of puncturing a surface of skin using the lancet device of claim 1, the method comprising:

disposing the skin engaging member of the lancet device against a user'"'"'s skin;

moving the skin engaging portion relative to the body so as to cause automatic triggering of the lancet device, whereby the holding member is caused to move to the extended position and the lancet needle is caused to penetrate the user'"'"'s skin,

wherein, after triggering, the user is at least one of prevented from moving the holding member to the retracted position and prevented from moving the skin engaging member to the initial position.

52. A method of using the lancet device of claim 1, the method comprising:

removing a triggering prevention device;

disposing the skin engaging member of the lancet device against a user'"'"'s skin; and

moving the skin engaging member relative the body,

wherein the moving automatically causes movement of the holding member towards the extended position.

53. A method of using the lancet device of claim 1, the method comprising:

removing a triggering prevention device;

disposing the skin engaging member of the lancet device against a user'"'"'s skin; and

non-rotatably moving the skin engaging member relative to the body,

wherein the non-rotatably moving automatically causes movement of the holding member towards the extended position.

54. A single-use lancet device, comprising:

a body;

a skin engaging member being at least partially disposed inside the body and comprising a lancet opening through which a lancet needle extends;

a holding member movably mounted within the body and comprising a front end and a rear end;

the holding member being movable at least between a retracted position and an extended position;

a first stop surface that moves with the skin engaging member; and

a second stop surface that moves with the holding member,

wherein movement of the skin engaging member from an initial position to a triggering position automatically causes the holding member to move towards the extended position, and

wherein after a triggering of the lancet device, the skin engaging member is caused to automatically move towards a retracted position and thereby prevent reuse of the single-use lancet device.

55. The lancet device of claim 54, wherein, once caused to move to the extended position, the holding member is prevented from moving back to the retracted position.

56. The lancet device of claim 54, further comprising a spring, wherein the spring causes the holding member to move to the extended position and prevents the holding member from moving back to the retracted position.

57. The lancet device of claim 54, further comprising a spring which causes movement of the holding member between the retracted position and the extended position and between the extended position and an intermediate position.

58. The lancet device of claim 54, wherein the holding member causes the skin engaging member to move further into the body after the lancet device is triggered.

59. The lancet device of claim 54, wherein the holding member causes the skin engaging member to move into the body after the lancet device is triggered.

60. A single-use lancet device, comprising:

a body;

a non-rotatably and slidably mounted skin engaging member being at least partially disposed inside the body;

the skin engaging member comprising a lancet opening through which a lancet needle extends;

a holding member movably mounted within the body and comprising a front end and a rear end; and

the holding member being movable at least between a retracted position and an extended position,

wherein movement of the skin engaging member further into the body automatically causes the holding member to move towards the extended position, and

wherein after a triggering of the lancet device, the skin engaging member is caused to automatically move towards a retracted position and thereby prevent reuse of the single-use lancet device.

61. A single use or disposable lancet device, comprising:

a body;

a movable skin engaging member being at least partially disposed inside the body and comprising a lancet opening through which a lancet needle extends; and

a holding member which can move at least between a retracted position and an extended position,

wherein the skin engaging member is structured and arranged to retract into the body, and

wherein after a triggering of the lancet device, the skin engaging member is caused to automatically move by the holding member towards a retracted position and thereby prevent reuse of the single-use or disposable lancet device.

62. A lancet device, comprising:

a body;

a skin engaging member structured and arranged to cause triggering of the lancet device and prevent reuse of the lancet device;

a lancet opening through which a lancet needle extends;

a holding member which can move at least between a retracted position and an extended position;

the holding member being structured and arranged to cause the skin engaging member to move further into the body from a triggering position after the lancet device is triggered; and

at least one of;

at least after the holding member moves to the extended position, the skin engaging member is covered by at least one of an outer sleeve and a portion of the body;

at least after triggering of the lancet device, a front edge of at least one of an outer sleeve and a portion of the body extends forwardly of a skin contact surface of the skin engaging member;

at least after the holding member moves to the extended position, the skin engaging member is covered by at least one of an inner sleeve and a portion of the body; and

at least after triggering of the lancet device, a front edge of at least one of an inner sleeve and a portion of the body extends forwardly of a skin contact surface of the skin engaging member.

63. A single-use lancet device, comprising:

a body;

a holding member movably mounted within the body;

a skin engaging member comprising a lancet opening, having, in an initial position, one portion arranged in the body and another portion arranged outside the body, and being configured to prevent reuse of the single-use lancet device,

wherein the single-use lancet device is triggered by movement of the skin engaging member to a triggering position from the initial position, and

wherein the holding member is structured and arranged to cause the skin engaging member to move further into the body from the triggering position after the lancet device is triggered.

64. A single-use lancet device, comprising:

a body;

a skin engaging member being movable with respect to the body and comprising a lancet opening through which a lancet needle extends;

a holding member movably mounted within the body and comprising a front end and a rear end;

the holding member being movable at least between a retracted position and an extended position;

a first stop surface that moves with the skin engaging member; and

a second stop surface that moves with the holding member,

wherein movement of the skin engaging member from an initial position to a triggering position causes the holding member to move towards the extended position,

wherein, once caused to move to the extended position, the holding member is prevented from moving back to the retracted position,

wherein after a triggering of the lancet device, the skin engaging member is caused to automatically move towards a retracted position, and

wherein, once caused to move to the triggering position, the skin engaging member is prevented from moving back to the initial position.

65. A single-use lancet device, comprising:

a body;

a skin engaging member being at least partially disposed inside the body and comprising a lancet opening through which a lancet needle extends;

a holding member movably mounted within the body and comprising a front end and a rear end;

the holding member being movable at least between a retracted position and an extended position;

a first stop surface that moves with the skin engaging member; and

a second stop surface that moves with the holding member,

wherein movement of the skin engaging member from an initial position to a triggering position automatically causes the holding member to move towards the extended position,

wherein after a triggering of the lancet device, the skin engaging member is caused to automatically move towards a retracted position, and

wherein, once caused to move to the triggering position, the skin engaging member is prevented from moving back to the initial position.