Adjustable lancet device and method

• US 20050234495A1
• Filed: 06/16/2005
• Published: 10/20/2005
• Est. Priority Date: 08/15/2003
• Status: Abandoned Application

• Current Assignee: Stat Medical Devices Incorporated
• Original Assignee: Stat Medical Devices Incorporated
• Inventors: Schraga, Steven
• Application Number:
  US11/153,381
• Publication Number:
  US 20050234495A1
• Time in Patent Office: Days
• US Class Current: 606/181
• CPC Class Codes: A61B 17/32093 for skin incisions
• CPC Class Codes: A61B 17/34 Trocars; Puncturing needles pointed biopsy instruments A61B10/0233; devices for piercing the ear-lobes A44C7/001; seals or hemostasis valves A61M39/06
• 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 5/150183 Depth adjustment mechanism using end caps mounted at the distal end of the sampling device, i.e. the end-caps are adjustably positioned relative to the piercing device housing for example by rotating or screwing
• 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 5/15029 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 5/151 Devices specially adapted for taking samples of capillary blood, e.g. by lancets , needles or blades
• 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 5/1519 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 having adjustable depth of penetration. The lancet device includes a body, a front cover comprising a skin engaging end that includes a lancet opening through which a lancet needle may extend, a holding member movably mounted within the body and including a front end and a rear end. A spring arranged to bias the holding member at least towards an extended position. A stop surface limiting movement of the holding member. An intermediate member at least one of adjustably connected to the body and threadably connected to the body. Movement of the intermediate member changes an overall length of the lancet device. 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 lancet device having adjustable depth of penetration, the 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 may extend;

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

a spring disposed between the front and rear ends of the holding member;

the front end being configured to receive a lancet having the lancet needle;

a first stop surface that moves with the holding member; and

an intermediate member at least one of;

axially adjustably connected to the body; and

threadably connected to the body.

2. The lancet device of claim 1, wherein the intermediate member is non-removably connected to the body and wherein the front cover is movably and removably connected to the intermediate member.

3. The lancet device of claim 1, wherein movement of the intermediate member adjusts a depth of penetration of the lancet needle.

4. The lancet device of claim 1, wherein the, front cover is non-rotatably mounted to the intermediate member.

5. The lancet device of claim 1, wherein the front cover is devoid of moving parts.

6. The lancet device of claim 1, wherein the front cover comprises a one-piece plastic or synthetic resin member.

7. The lancet device of claim 1, wherein movement of the intermediate member changes an overall length of the lancet device and wherein the intermediate member is spaced from the front cover.

8. The lancet device of claim 1, wherein movement of the intermediate member changes an overall length of the lancet device and wherein the front cover is at least one of:

devoid of moving parts; and

a one-piece plastic or synthetic resin member.

9. The lancet device of claim 1, wherein the lancet device is structured and arranged to allow for replacement of the lancet and for multiple use.

10. The lancet device of claim 1, wherein the lancet is removably connected to the front end of the holding member.

11. The lancet device of claim 1, further comprising an arrangement for moving the holding member to a retracted or trigger-set position.

12. The lancet device of claim 1, wherein the spring biases the holding member towards the extended position, and further comprising another spring for biasing the holding member in an opposite direction.

13. The lancet device of claim 12, wherein the spring and the other spring are arranged to surround different portions of the holding member.

14. The lancet device of claim 1, wherein the spring has one end that is coupled the holding member and another end coupled to a portion of the body.

15. The lancet device of claim 1, wherein the holding member comprises a generally cylindrical cross-section.

16. The lancet device of claim 1, wherein the holding member comprises a generally polygonal cross-section.

17. The lancet device of claim 1, further comprising a locking member mounted to the holding member, wherein the locking member is engagable with the trigger.

18. The lancet device of claim 1, further comprising a deflecting member coupled to the holding member, wherein the deflecting member is engagable with the trigger.

19. The lancet device of claim 1, wherein the trigger is movably mounted to the body and further comprising a second stop surface that is contacted by the first stop surface when the lancet moves to an extended position.

20. The lancet device of claim 1, wherein the front cover is removably and non-threadably mounted to a front portion of the body and wherein the intermediate member is non-removably mounted to a rear portion of the body.

21. The lancet device of claim 1, further comprising a mechanism for at least temporarily maintaining a depth setting position of the intermediate member.

22. The lancet device of claim 1, wherein the holding member comprises an integrally formed deflecting member that engages a surface of the body.

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

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

25. The lancet device of claim 24, wherein the deflecting member is coupled to the holding member.

26. The lancet device of claim 24, wherein the deflecting member comprises an engaging surface that contacts a surface of the body.

27. The lancet device of claim 26, wherein the deflecting member is integrally formed with the holding member.

28. The lancet device of claim 1, further comprising indicia arranged on at least one of the intermediate member and the body.

29. The lancet device of claim 28, wherein the indicia is arranged on an outer circumferential surface of the body.

30. The lancet device of claim 28, wherein the indicia is arranged on an outer circumferential surface of the intermediate member.

31. The lancet device of claim 1, wherein the front cover rotates about an axis that runs through the lancet opening and the holding member without changing an overall length of the lancet device.

32. The lancet device of claim 1, wherein the spring is disposed between the trigger and a back cap.

33. The lancet device of claim 32, further comprising another spring axially retained between walls of the two-piece body.

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

35. The lancet device of claim 1, further comprising a back cap movably mounted to the body.

36. The lancet device of claim 1, wherein the body comprises an ergonomic shape.

37. The lancet device of claim 1, wherein the body comprises a plastic material.

38. The lancet device of claim 1, wherein the intermediate member comprises at least one of:

an external high-friction gripping surface; and

gripping protrusions.

39. The lancet device of claim 1, further comprising threads connecting the intermediate member to the body.

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

adjusting a set depth of penetration by rotating the intermediate member to a desired set position;

disposing the skin engaging end 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.

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

rotating the intermediate member to a desired set position;

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

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

triggering the trigger to cause movement of the holding member.

42. A lancet device having adjustable depth of penetration, the lancet device comprising:

a body;

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

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

a spring arranged to bias the holding member at least towards an extended position;

a stop surface limiting movement of the holding member;

an adjustment mechanism at least one of;

adjustably connected to the body; and

threadably connected to the body,

and further comprising at least one of;

the front cover is removably connected to the adjustment mechanism wherein movement of the adjustment mechanism changes an overall length of the lancet device, and

the front cover is removably connected to a front portion of the body and the adjustment mechanism is spaced from the front portion of the body wherein movement of the adjustment mechanism changes an overall length of the lancet device.

43. The lancet device of claim 42, at least one of:

the adjustment mechanism and the front cover comprise separate and distinct structures; and

the adjustment mechanism and the front cover each comprise a one-piece member.

44. The lancet device of claim 42, wherein the adjustment mechanism and the front cover each comprise a one-piece plastic or synthetic resin member.

45. A lancet device having adjustable depth of penetration, the lancet device comprising:

a body;

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

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

a stop surface limiting movement of the holding member; and

an adjustment mechanism arranged between the body and the front cover;

the adjustment mechanism being at least one of;

adjustably connected to the body;

axially movably mounted to the body; and

threadably connected to the body,

wherein the front cover is removably connected to one of the adjustment mechanism and a front portion of the body and wherein movement or adjustment of the adjustment mechanism changes an overall length of the lancet device.

46. The lancet device of claim 45, wherein the adjustment mechanism and the front cover comprise separate and distinct structures.

47. The lancet device of claim 45, wherein the adjustment mechanism and the front cover each comprise a one-piece member.

48. The lancet device of claim 45, wherein the adjustment mechanism comprises at least one of:

an external high-friction gripping surface;

external gripping protrusions; and

a mechanism for indicating a depth setting position.

49. A method of puncturing a surface of skin using the lancet device of claim 45, the method comprising:

adjusting a depth of penetration by rotating the adjustment mechanism to a desired set depth position;

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

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

wherein the adjusting does not change a position of the stop surface relative to the body and changes an overall length of the lancet device.

50. A method of puncturing a surface of skin using the lancet device of claim 45, the method comprising:

adjusting a depth of penetration by rotating the adjustment mechanism relative to the body to a desired set depth position;

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

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

wherein the adjusting does not change a position of the stop surface relative to the body and changes an overall length of the lancet device.