Lancing device with combination depth and activation control

• US 20050143771A1
• Filed: 12/02/2004
• Published: 06/30/2005
• Est. Priority Date: 12/02/2003
• Status: Abandoned Application

• Current Assignee: Tower Square Capital Partners (Barings LLC (Private Equity))
• Original Assignee: Tower Square Capital Partners (Barings LLC (Private Equity))
• Inventors: LeVaughn, Richard W., Lathrop, Ray Adams, Stout, Jeffrey T.
• Application Number:
  US11/001,771
• Publication Number:
  US 20050143771A1
• Time in Patent Office: Days
• US Class Current: 606/181
• 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 5/150259 Improved gripping, e.g. with high friction pattern or projections on the housing surface or an ergonometric shape
• CPC Class Codes: A61B 5/150435 Specific design of proximal end
• CPC Class Codes: A61B 5/150549 Protectors removed by rotational movement, e.g. torsion or screwing
• CPC Class Codes: A61B 5/150564 Protectors removed by pulling or pushing
• CPC Class Codes: A61B 5/150717 manually removed
• CPC Class Codes: A61B 5/150809 by audible feedback
• CPC Class Codes: A61B 5/150816 by tactile feedback, e.g. vibration
• CPC Class Codes: A61B 5/150824 by visual feedback
• CPC Class Codes: A61B 5/150885 Preventing re-use
• 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 5/15144 comprising driving means, e.g. a spring, for retracting the piercing unit into the housing

Abstract

A lancet, a housing for the lancent, and a combination depth and activation control assembly. The lancet includes a needle, a needle-holding section, and an operating section with an opening. A drive spring is mounted within the opening and between the lancet body and the housing. The control assembly includes a control member with a control interface knob and a control shaft. The control shaft has multiple stop surfaces that are alignable with an engagement surface on the lancet body to control the lancing depth. And the control shaft has a release surface that engages the release member to disengage the engagement member to activate the lancing stroke. Additional features includes a safety interlock for preventing accidental activiation of the lancing device, ridges on the housing for providing discrete locked and depth setting positions, and a keyed sterility cap for preventing accidental removal of the cap.

Claims

1. A lancing device, comprising:

a lancet movable from a charged position ready for use to an extended position for puncturing skin;

a release member that engages and retains the lancet in the charged position; and

a combination depth and activation control assembly including a control member having a plurality of stop surfaces and a release surface, wherein the control member is movable to position the stop surfaces to stop the lancet at a plurality of different depths, and the control member is movable to position the release surface in engagement with the release member to release the lancet to travel to the extended position.

2. The lancing device of claim 1, wherein the control member includes a control shaft that defines the stop surfaces, and the control shaft rotates to position one or another of the stop surfaces to contact and stop the lancet.

3. The lancing device of claim 2, wherein a first one of the stop surfaces is spaced closer to a rotational axis of the control shaft than a second one of the stop surfaces, wherein the first stop surface stops the lancet at a longer travel and deeper puncture depth than the second stop surface.

4. The lancing device of claim 1, wherein the control member includes a control shaft that defines the release surface, and the control shaft moves axially to push the release member out of engagement with the lancet to activate the lancing device.

5. The lancing device of claim 2, wherein the control member includes a control shaft that defines the release surface, and the control shaft moves axially to push the release member out of engagement with the lancet to activate the lancing device.

6. The lancing device of claim 1, wherein the lancet has an engagement surface, the release member engages the engagement surface to retain the lancet in the charged position, and the stop surfaces engage the engagement surface to stop the lancet in the extended position.

7. The lancing device of claim 1, further comprising a spring that propels the lancet from the charged position to the extended position, wherein the lancet includes a lancet body that defines an opening, and the spring is positioned within the opening.

8. The lancing device of claim 7, further comprising a support arm extending into the opening, wherein the spring is mounted to the lancet body and the support arm.

9. The lancing device of claim 8, wherein the support arm supports the control shaft.

10. The lancing device of claim 8, wherein the opening is defined by an inner wall of the lancet body, the inner wall defines an engagement surface at a rearward portion of the lancet body, and the stop surfaces engage the engagement surface to stop the lancet in the extended position.

11. The lancing device of claim 1, further comprising a housing for the lancet, wherein the housing defines at least one lock opening, the control member includes a control interface member with at least one lock tab extending therefrom, and the control interface is movable from a locked position with the lock tab not aligned with the control opening to a plurality of depth setting positions with the lock tab aligned with and receivable in the control opening to permit movement of the control member.

12. A lancing device, comprising:

a lancet movable from a charged position ready for use to an extended position for puncturing skin, the lancet having a lancet body defining an engagement surface;

a release member movable from a set position engaging the lancet body engagement surface and retaining the lancet in the charged position to an activation position releasing the lancet to travel to the extended position; and

a combination depth and activation control assembly including a control member having a control interface and a control shaft extending therefrom, the control shaft having a release surface and first and second stop surfaces, wherein the control interface is rotatable to rotate the control shaft to position either the first stop surface or the second stop surface to contact the lancet body engagement surface to stop the lancet in the extended position at a first or a second puncture depth, and wherein the control interface is depressible to axially move the control shaft to push the release surface against the release member to move the release member from the set position to the activation position to activate the lancing device.

13. The lancing device of claim 12, wherein the first stop surface is spaced closer to a rotational axis of the control shaft than the second stop surface, wherein the first stop surface stops the lancet at a longer travel and deeper puncture depth than the second stop surface.

14. The lancing device of claim 12, wherein the first and second stop surfaces are positioned between the release surface and the control interface.

15. The lancing device of claim 12, further comprising a spring that propels the lancet from the charged position to the extended position, wherein the lancet body has an inner wall that defines an opening and that defines the engagement surface at a rearward portion of the lancet body, and the spring is positioned within the opening.

16. The lancing device of claim 15, further comprising a support arm extending into the opening, wherein the spring is mounted to the lancet body and the support arm, and the support arm supports the control shaft.

17. The lancing device of claim 12, wherein the lancet body includes a peripheral wall that has a generally rectangular shape and that defines the opening.

18. The lancing device of claim 12, wherein the release member is biased toward the set position, defines a catch surface that engages the lancet body engagement surface in the charged position, and defines a ramped section that engages the control shaft release surface to deflect the release member from the set position when moving the lancet to the charged position.

19. The lancing device of claim 12, wherein the release member includes a weak segment that fails upon movement to the activation position to disable the lancing device.

20. The lancing device of claim 12, further comprising a housing for the lancet, wherein the housing defines at least one lock opening, the control interface has at least one lock tab extending therefrom, and the control interface is movable from a locked position with the lock tab not aligned with the control opening to first and second depth setting positions with the lock tab aligned with and receivable in the control opening to permit the axial movement of the control member.

21. A lancing device, comprising:

a lancet movable from a charged position ready for use to an extended position for puncturing skin, the lancet including a body and a puncturing element extending from a forward portion of the lancet body, the lancet body having an inner wall that defines an opening and defines an engagement surface at a rearward portion of the lancet body;

a spring that propels the lancet forward from the charged position to the extended position, wherein the spring is positioned within the opening; and

a control member defining at least one stop surface that engages the lancet body engagement surface to stop the lancet in the extended position, wherein the impact of the lancet member engagement surface and the stop surface is remote from the puncturing element.

22. The lancing device of claim 21, further comprising a support arm extending into the opening, wherein the spring is mounted to the lancet body and the support arm and the support arm supports the control member.

23. The lancing device of claim 21, further comprising a release member that engages the lancet body engagement surface and retains the lancet in the charged position.

24. A lancing device, comprising:

a housing defining at least one lock opening;

a lancet movable from a charged position ready for use to an extended position for puncturing skin;

a control member having a control interface member with at least one lock tab extending therefrom, wherein the control interface is movable from a locked position with the lock tab not aligned with the lock opening to at least one unlocked position with the lock tab aligned with and receivable in the lock opening to permit the control member to move to activate the lancing device.

25. The lancing device of claim 24, wherein the housing defines a plurality of ridges with gaps therebetween, the gaps positioned to receive the lock tab when the control interface is in the locked position and the at least one unlocked position to provide discrete positioning of the control interface.

26. The lancing device of claim 25, wherein the housing defines a deflection member that engages and is deflected by the lock tab when the control interface is moved from the locked position to the at least one unlocked position.

27. A lancing device, comprising:

a housing defining at least one lancing opening;

a lancet having a body and a puncturing element extending from the body, wherein the lancet is movable from a charged position within the housing to an extended position with the puncturing element extending though the lancing opening for puncturing skin; and

a sterility cap positioned on the puncturing element and removable for use, wherein the sterility cap has a sheath portion that extends into the housing through the lancing opening, the sterility cap defines at least one first key element on the sheath portion within the housing and the housing defines at least one second key element at the lancing opening, and the sterility cap is rotatable from a locked position with the first and second key elements not in alignment to an unlocked position with the first and second key elements in alignment and permitting the sterility cap to be removed from the puncturing element.