Adjustable lancet device and method

• US 7,105,006 B2
• Filed: 08/15/2003
• Issued: 09/12/2006
• Est. Priority Date: 08/15/2003
• Status: Active Grant

• Current Assignee: Stat Medical Devices Incorporated
• Original Assignee: Stat Medical Devices Incorporated
• Inventors: Shraga, Steven
• Primary Examiner(s): McDermott, Corrine
• Assistant Examiner(s): PRONE, CHRISTOPHER D
• Application Number:
  US10/641,101
• Publication Number:
  US 20050038464A1
• Time in Patent Office: 1,124 Days
• Field of Search: 606/182, 606/181, 606/172
• US Class Current: 606/182
• CPC Class Codes: A61B 5/150022 for capillary blood or interstitial fluid
• CPC Class Codes: A61B 5/15019 Depth adjustment mechanism using movable stops located inside the piercing device housing and limiting the travel of the drive mechanism mechanisms using distal end caps A61B5/150183, mechanisms at the piercing element carrier proximal end A61B5/150198
• CPC Class Codes: A61B 5/15029 for driving devices, i.e. means for driving the piercing element
• 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 5/150824 by visual feedback
• CPC Class Codes: A61B 5/15113 Manually triggered, i.e. the triggering requires a deliberate action by the user such as pressing a drive button
• 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 5/15186 Devices loaded with a single lancet, i.e. a single lancet with or without a casing is loaded into a reusable drive device and then discarded after use; drive devices reloadable for multiple use
• CPC Class Codes: A61B 5/1519 comprising driving means, e.g. a spring, for propelling the piercing unit
• CPC Class Codes: A61B 5/15194 fully automatically retracted, i.e. the retraction does not require a deliberate action by the user, e.g. by terminating the contact with the patient's skin

Abstract

Lancet device that includes a body. A trigger is mounted to the body. A front cover has a skin engaging end that includes a lancet opening through which a lancet needle extends. A holding member is movably mounted within the body and includes a front end a rear end. The front end can be configured to receive a lancet. A stop surface moves with the holding member. A cam wheel includes cam surfaces which can be contacted by the stop surface. The cam wheel is configured to rotate at least partially. The cam wheel rotates about an axis that is parallel to an axis running through at least one of the lancet opening and the holding member.

Claims

1. A lancet device, comprising:

a body comprising a side opening arranged between front and rear ends of the body;

a trigger;

a front cover comprising a skin engaging end that includes 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 front end being configured to receive a lancet;

a stop surface that moves with the holding member;

a cam wheel comprising cam surfaces which can be contacted by the stop surface; and

the cam wheel being configured to rotate at least partially about an axis that is at least substantially parallel to an axis running through at least one of the lancet opening and the holding member,

wherein a portion of the cam wheel projects out from the side opening.

2. The lancet device of claim 1, further comprising a back cap configured to move between a retracted position and an original position.

3. The lancet device of claim 2, wherein the back cap is configured to move the holding member to a retracted position.

4. The lancet device of claim 2, wherein the back cap is coupled to a surface that engages the rear end of the holding member.

5. The lancet device of claim 2, wherein the back cap is coupled to an inner sleeve that includes a surface that engages the rear end of the holding member.

6. The lancet device of claim 5, wherein the inner sleeve comprises an opening that receives a rear end of the holding member.

7. The lancet device of claim 2, wherein the back cap is coupled to in inner sleeve that includes a surface that engages projections disposed on the rear end of the holding member.

8. The lancet device of claim 2, further comprising a spring for biasing the back cap towards an original position.

9. The lancet device of claim 1, further comprising a first spring for biasing the holding member towards an extended position and a second spring for biasing the holding member in an opposite direction.

10. The lancet device of claim 9, wherein the first spring contacts one side of a projection extending inwardly from the body and wherein the second spring contacts another side of the projection.

11. The lancet device of claim 10, further comprising an end plug mounted to the rear end of the holding member.

12. The lancet device of claim 11, wherein the first spring is disposed between the projection and an inner wall surface arranged in the area of the front end of the holding member and wherein the second spring is disposed between the projection and the end plug.

13. The lancet device of claim 1, wherein the trigger is movably mounted to the body.

14. The lancet device of claim 1, wherein the front cover is removably mounted to the body.

15. The lancet device of claim 1, wherein the holding member comprises a projection that includes the stop surface.

16. The lancet device of claim 1, wherein the holding member comprises an integrally formed projection that includes the stop surface.

17. The lancet device of claim 1, wherein the front end comprises an opening that is configured to removably receive the lancet.

18. The lancet device of claim 1, further comprising a deflecting member configured to be deflected by the trigger.

19. The lancet device of claim 18, wherein the deflecting member is coupled to the holding member.

20. The lancet device of claim 18, wherein the deflecting member comprises a first stop surface that contacts a first surface of a holding projection extending inwardly from the body.

21. The lancet device of claim 20, wherein the deflecting member is integrally formed with the holding member.

22. The lancet device of claim 1, wherein the cam wheel comprises indicia.

23. The lancet device of claim 22, wherein the cam surfaces are arranged on an annular cam section of the cam wheel and wherein the indicia is arranged on an outer circumferential surface of the cam wheel.

24. The lancet device of claim 1, wherein the cam wheel comprises a centrally disposed opening that is mounted about the holding member.

25. The lancet device of claim 24, wherein the holding member comprises a front portion that includes the front end and a rear portion that includes the rear end, wherein the front and rear portions are connected together.

26. The lancet device of claim 24, wherein the rear portion comprises a slot which at least partially receives a projection that extends from the body.

27. The lancet device of claim 1, wherein the cam wheel rotates about an axis that runs through the lancet opening and the holding member.

28. The lancet device of claim 1, wherein the cam wheel is disposed between the trigger and a back cap.

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

30. The lancet device of claim 29, wherein the cam wheel is axially retained between walls of the two-piece body.

31. The lancet device of claim 30, wherein the front cover is removably mounted to the two-piece body.

32. The lancet device of claim 31, further comprising a back cap movably mounted to the two-piece body.

33. The lancet device of claim 1, wherein the body comprises two oppositely arranged curved side indentations.

34. The lancet device of claim 1, wherein the side opening constitutes a mechanism for viewing indicia of the cam wheel.

35. The lancet device of claim 34, wherein the mechanism for viewing indicia of the cam wheel comprises a slot.

36. The lancet device of claim 1, further comprising a ratchet pawl which engages an annular undulating surface of the cam wheel, whereby the cam wheel is maintained at a desired set-depth position.

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

adjusting a set depth of penetration of the needle by rotating the cam wheel to a desired set position;

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

triggering the trigger to cause the lancet needle to penetrate the user'"'"'s skin,

wherein the puncture allows a blood sample to be taken.

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

rotating the cam wheel to a desired set position;

moving the holding member to a retracted position;

maintaining the holding member in the retracted position until the trigger is triggered;

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

triggering the trigger to cause movement of the holding member.

39. A lancet device, comprising:

a body;

a tripper;

a front cover comprising a skin engaging end that includes 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 front end being configured to receive a lancet;

a stop surface that moves with the holding member;

a cam wheel comprising cam surfaces which can be contacted by the stop surface;

the cam wheel being configured to rotate at least partially about an axis that is at least substantially parallel to an axis running through at least one of the lancet opening and the holding member, and

a first spring for biasing the holding member towards an extended position and a second spring for biasing the holding member in an opposite direction,

wherein the first and second springs are arranged within an axial opening of the holding member.

40. A lancet device, comprising:

a body;

a trigger;

a front cover comprising a skin engaging end that includes 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 front end being configured to receive a lancet;

a stop surface that moves with the holding member;

a cam wheel comprising cam surfaces which can be contacted by the stop surface;

the cam wheel being configured to rotate at least partially about an axis that is at least substantially parallel to an axis running through at least one of the lancet opening and the holding member;

a first spring for biasing the holding member towards an extended position and a second spring for biasing the holding member in an opposite direction, and

the first spring contacting one side of a protection extending inwardly from the body and the second spring contacting another side of the projection,

wherein the projection extends into an elongated slot formed in the holding member.

41. A lancet device, comprising:

a body;

a trigger;

a front cover comprising a skin engaging end that includes 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 front end being configured to receive a lancet;

a stop surface that moves with the holding member;

a cam wheel comprising cam surfaces which can be contacted by the stop surface;

the cam wheel being configured to rotate at least partially about an axis that is at least substantially parallel to an axis running through at least one of the lancet opening and the holding member and comprising a centrally disposed opening that is mounted about the holding member; and

the rear portion comprising a slot which at least partially receives a projection that extends from the body,

wherein the front portion comprises a deflecting member configured to be deflected by the trigger.

42. A lancet device, comprising:

a body;

a trigger;

a front cover comprising a skin engaging end that includes 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 front end being configured to receive a lancet;

a stop surface that moves with the holding member;

a cam wheel comprising cam surfaces which can be contacted by the stop surface; and

the cam wheel being configured to rotate at least partially about an axis that is at least substantially parallel to an axis running through at least one of the lancet opening and the holding member,

wherein the body comprises at least one curved side indentation through which the cam wheel protrudes.

43. A lancet device, comprising:

a body;

a trigger;

a front cover comprising a skin engaging end that includes a lancet opening through which a lancet needle extends;

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

the front end being configured to receive a lancet;

a stop projection coupled to the holding member; and

a cam wheel comprising indicia and annular cam surfaces which can be contacted by the stop projection;

the cam wheel being configured to rotate at least partially;

each annular cam surface of the cam wheel being contacted by the stop protection when each annular cam surface is located in a predetermined position,

wherein the cam wheel is axially retained between walls of the body.

44. A lancet device, comprising:

a body;

a trigger;

a front cover comprising a skin engaging end that includes a lancet opening through which a lancet needle extends;

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

the front end being configured to receive a lancet;

a back cap configured to move the holding member to a retracted position;

a stop surface coupled to the holding member;

a cam wheel at least partially arranged within the body;

the cam wheel comprising indicia and annular cam surfaces which can be contacted by the stop projection; and

the cam wheel being configured to rotate at least partially,

each annular cam surface of the cam wheel being contacted by the stop projection when each annular cam surface is located in a predetermined position,

wherein the cam wheel protrudes from at least one side wall of the body.