Single Puncture Lancing Fixture with Depth Adjustment and Control of Contact Force

• US 20080119884A1
• Filed: 09/08/2005
• Published: 05/22/2008
• Est. Priority Date: 09/09/2004
• Status: Abandoned Application

• Current Assignee: Bayer Healthcare LLC (Bayer AG)
• Original Assignee: Bayer Healthcare LLC (Bayer AG)
• Inventors: Siddons, George V., Hesser, Donald R., Brenneman, Allen J., Flora, Bruce A.
• Application Number:
  US11/661,226
• Publication Number:
  US 20080119884A1
• Time in Patent Office: Days
• US Class Current: 606/182
• 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 5/150198 Depth adjustment mechanism at the proximal end of the carrier of 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 5/150503 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 5/15111 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 5/15113 Manually triggered, i.e. the triggering requires a deliberate action by the user such as pressing a drive button
• CPC Class Codes: A61B 5/15123 comprising magnets or solenoids
• CPC Class Codes: A61B 5/15128 comprising 2D- or 3D-shaped elements, e.g. cams, curved guide rails or threads 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

A lancing mechanism fixture for puncturing skin with a lancet having a penetration end being moveable in a direction substantially parallel to the longitudinal axis of the lancet, the penetration end being moveable from a first position to a second position during a forward stroke, the penetration end being movable from the second position back to the first position during a return stroke. The motion of the lancet is controlled by a cam mechanism including a slot cam and a cam follower connected to a lancet. A drive member applies a linear force to the slot cam whose linear motion and slot path shape forces the lancet to move from a first position to a second position and back to the first position.

Claims

1. A lancing mechanism fixture for puncturing skin comprising:

a lancet disposed on the fixture having a penetration end being adapted to puncture skin, the penetration end being moveable in a direction substantially parallel to a longitudinal axis of the lancet, the penetration end of the lancet being moveable from a first position to a second position during a forward stroke, the penetration end of the lancet being movable from the second position back to the first position during a return stroke;

a cam mechanism including a slot cam and a cam follower, the cam follower connected to the lancet, the cam follower engaged to the slot cam such that the longitudinal axis of the slot cam is generally perpendicular to the longitudinal axis of the lancet, the slot cam being moveable along its longitudinal axis to move the cam follower and connected lancet a fixed distance; and

a drive member connected to the slot cam, the drive member adapted to assist in moving the slot cam.

2. The lancing mechanism of claim 1, further comprising an endcap located along the lancet'"'"'s travel axis, the endcap positioning a surface of the skin a distance from the penetration end, the endcap including a hole therethrough in which the penetration end passes to puncture the skin surface.

3. The lancing mechanism of claim 2, further including a force registering member connected to the endcap that registers the amount of force applied to the endcap.

4. The lancing mechanism of claim 3, wherein the force registering member is an annular load cell.

5. The lancing mechanism of claim 3, where in the force registering member is a spring loaded mechanism.

6. The lancing mechanism of claim 3, wherein the force registering member activates the drive member when a predetermined amount of force is applied to the endcap.

7. The lancing mechanism of claim 2, further including a penetration end adjustment mechanism and an endcap adjustment mechanism for adjusting the puncture depth of the lancet.

8. The lancing mechanism of claim 7, further including a high speed video system.

9. The lancing mechanism of claim 7, wherein the endcap is generally transparent with measurement markings.

10. The lancing mechanism of claim 7, wherein the endcap includes a viewing lens and measurement markings.

11. The lancing mechanism of claim 1, wherein the drive member is a linear induction motor.

12. The lancing mechanism of claim 1, wherein the drive member is a spring drive mechanism.

13. The lancing mechanism of claim 1, wherein the longitudinal axis of the slot cam is substantially perpendicular to the longitudinal axis of the lancet.

14. The lancing mechanism of claim 13, wherein the longitudinal axis of the slot cam is perpendicular to the longitudinal axis of the lancet.

15. A lancing mechanism fixture for puncturing skin comprising:

a lancet disposed on the fixture having a penetration end being adapted to puncture skin, the penetration end being moveable in a direction substantially parallel to a longitudinal axis of the lancet, the penetration end of the lancet being moveable from a first position to a second position during a forward stroke, the penetration end of the lancet being movable from the second position back to the first position during a return stroke;

a cam mechanism including a slot cam and a cam follower, the cam follower connected to the lancet, the cam follower engaged to the slot cam such that the longitudinal axis of the slot cam is substantially perpendicular to the longitudinal axis of the lancet, the slot cam being moveable along its longitudinal axis to move the cam follower and connected lancet a fixed distance;

a drive member connected to the slot cam, the drive member adapted to assist in moving the slot cam; and

an endcap located along the lancet'"'"'s travel axis, the endcap positioning a surface of the skin a distance from the penetration end, the endcap comprising a hole therethrough in which the penetration end passes to puncture the skin surface.

16. The lancing mechanism of claim 15, further including a force registering member connected to the endcap that registers the amount of force applied to the endcap.

17. The lancing mechanism of claim 16, wherein the force registering member is an annular load cell.

18. The lancing mechanism of claim 16, where in the force registering member is a spring loaded mechanism.

19. The lancing mechanism of claim 16, wherein the force registering member activates the drive member when a predetermined amount of force is applied to the endcap.

20. The lancing mechanism of claim 15, further including a penetration end adjustment mechanism and an endcap adjustment mechanism for adjusting the puncture depth of the lancet.

21. The lancing mechanism of claim 20, further including a high speed video system.

22. The lancing mechanism of claim 20, wherein the endcap is generally transparent with measurement markings.

23. The lancing mechanism of claim 20, wherein the endcap includes a viewing lens and measurement markings.

24. The lancing mechanism of claim 15, wherein the drive member comprises a linear induction motor.

25. The lancing mechanism of claim 15, wherein said drive member comprises a spring drive mechanism.

26. The lancing mechanism of claim 15, wherein the longitudinal axis of the slot cam is perpendicular to the longitudinal axis of the lancet.

27. A lancing mechanism fixture for puncturing skin comprising:

a lancet disposed on the fixture having a penetration end being adapted to puncture skin, the penetration end being moveable in a direction substantially parallel to a longitudinal axis of the lancet, the penetration end of the lancet being moveable from a first position to a second position during a forward stroke, the penetration end of the lancet being movable from the second position back to the first position during a return stroke;

a cam mechanism including a slot cam and a cam follower, the cam follower connected to the lancet, the cam follower engaged to the slot cam such that the longitudinal axis of the slot cam is generally perpendicular to the longitudinal axis of the lancet, the slot cam being moveable along its longitudinal axis to move the cam follower and connected lancet a fixed distance;

a spring device connected to the slot cam, the spring device adapted to assist in moving the slot cam a fixed distance;

an endcap, located along the lancet'"'"'s travel axis positioning the skin surface a distance from the penetration end, the endcap comprising a hole through which the penetration end passes to puncture the skin;

a force registering member connected to the endcap that registers the amount of force applied to the endcap, the force registering member activating the drive member when a predetermined amount of force is applied to the endcap; and

a penetration end adjustment mechanism and an endcap adjustment mechanism for adjusting the puncture depth of the penetration end of the lancet.

28. A method for puncturing skin to obtain a blood sample with a lancing mechanism, the lancing mechanism including a slot cam, lancet, endcap, drive member, and trigger, the method comprising the acts of:

pressing the user'"'"'s skin against the endcap connected to a force registering member;

determining the force applied to the endcap; and

initiating the drive member if a predetermined amount of force is applied to the endcap, the drive member causing the slot cam to move in a linear direction, the linear movement of the slot cam causing the lancet to move from a first position to a second position and back to the first position, resulting in a single puncture in the user'"'"'s skin.

29. The method of claim 28, further including the act of adjusting the position of the penetration end and the endcap to ensure the desired clearance between the skin surface and the penetration end.