Adjustable tip for a lancet device and method

• US 8,709,032 B2
• Filed: 12/19/2002
• Issued: 04/29/2014
• Est. Priority Date: 01/28/2000
• Status: Expired due to Fees

• Current Assignee: Stat Medical Devices Incorporated
• Original Assignee: Stat Medical Devices Incorporated
• Inventors: Schraga, Steven
• Primary Examiner(s): Dowe, Katherine
• Assistant Examiner(s): MENDOZA, MICHAEL G
• Application Number:
  US10/322,530
• Publication Number:
  US 20030088261A1
• Time in Patent Office: 4,149 Days
• Field of Search: 606181-183, 606/172, 606/185
• US Class Current: 606/182
• CPC Class Codes: A61B 5/1411 by percutaneous method, e.g. by lancet
• CPC Class Codes: A61B 5/15107 Piercing being assisted by a triggering mechanism
• 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: A61M 3/00 Medical syringes, e.g. enemata; Irrigators A61M5/00 takes precedence; pistons A61M5/315

Abstract

A lancet device and a lancet device tip for a lancet device. The tip includes a first sleeve and a second sleeve at least partially contained within the first sleeve. The second sleeve includes a stop surface. Rotation of the first sleeve relative to the second sleeve causes the second sleeve to move at least axially without changing an overall length of the lancet device tip.

Claims

1. A tip assembly which can be removably mounted to a lancet device that includes a housing portion and that can receive a lancet having a needle, the tip assembly comprising:

a first sleeve including a side wall portion and a stop surface;

the side wall portion comprising a camming slot;

the stop surface including a first opening and being adapted to limit movement of the lancet;

the first opening being adapted to allow the portion of the needle to pass therethrough when the lancet contacts the stop surface;

a rotatably mounted second sleeve adapted to contact a user'"'"'s skin;

the second sleeve comprising a second opening and at least one following element that projects inwardly from an inner surface;

the at least one following element extending into the camming slot;

the second sleeve defining a plane beyond which a portion of the needle extends after the portion of the needle passes through the second opening;

a distance between the plane and the stop surface being adjustable in response to movement of the at least one following element within the camming slot;

the distance between the stop surface and the plane increasing when the second sleeve is at least partially rotated in one direction;

the distance between the stop surface and the plane decreasing when the second sleeve is at least partially rotated in an another direction; and

at least one tooth projecting from the lancet stop sleeve, wherein the at least one tooth engages with an internal spline.

2. A lancet device comprising:

a front end;

a rear end;

a trigger mechanism arranged at the rear end;

an outer member arranged at the front end and being structured and arranged to be gripped by a user;

the outer member comprising a skin engaging surface and an opening which allows a lancet needle to pass therethrough, wherein rotation of the outer member changes a depth of penetration of a lancet needle;

a sleeve comprising a portion that is arranged within the outer member, wherein the sleeve rotates and moves axially when the outer member rotates; and

a plurality of teeth and a projection which engages the teeth, wherein the projection engages some of the teeth when the outer member is rotated, and wherein the projection moves axially relative to the teeth during rotation of the outer member.

3. A tip having depth adjustment for a lancet device, comprising:

a one-piece member comprising;

a first end having a side wall portion; and

a second end structured and arranged to be removably connected to the lancet device;

a rotatable member mounted to the one-piece member;

a lancet stop surface arranged within the rotatable member;

the rotatable member comprising;

an inside surface surrounding the side wall portion and the lancet stop surface; and

a skin-engaging surface at least partially defining a plane beyond which a lancet needle may extend;

the lancet stop surface being spaced from the plane;

a slot arranged on the rotatable member;

at least one following element extending into the slot;

at least one tooth;

internal spline teeth; and

another slot arranged in the side wall portion, wherein the second end comprises engaging lugs disposed on an inside surface which snap into engaging grooves on an external surface of the lancet device,

wherein rotation of the rotatable member relative to the one-piece member;

causes a change in distance between the lancet stop surface and the plane; and

overcomes torque resistance created by the at least one tooth and the internal spline teeth.

4. A front assembly having depth of penetration adjustment and being usable on a lancet device, comprising:

a front cap member comprising a front end, a rear end, and an outer bearing surface arranged between the front end and the rear end;

a stop surface adapted to be contacted by a lancet having a lancet needle and an opening adapted to allow passage therethrough of the lancet needle;

the stop surface being located inside the front end of the front cap member;

the rear end of the front cap member being removably connectable to a lancet body of the lancet device;

a guide mechanism arranged on the outer bearing surface of the front cap member;

an outer member comprising an inner bearing surface structured and arranged to rotatably engage the outer bearing surface of the front cap member;

a skin engaging surface arranged in front of and spaced from the stop surface and defining a plane beyond which a tip of the lancet needle protrudes and defining the depth of penetration;

the skin engaging surface comprising an opening adapted to allow passage therethrough of the lancet needle;

the skin engaging surface rotating relative to the stop surface when the space between the stop surface and the skin engaging surface changes;

the outer member being rotatable between at least a first position and a second position;

at least one following element protruding inwardly from the outer member;

the at least one following element movably engaging with the guide mechanism when the outer member moves between the first position and the second position; and

a least one tooth engaging different teeth of an internal spline in the first position than in the second position,

wherein, when the front assembly is installed on the lancet body, the lancet needle is capable of extending beyond the plane by a different amount in the first position than in the second position.

5. The front assembly of claim 4, further comprising:

indicating marks arranged on a surface that rotates with the outer member;

the front cap member comprising a reference mark and being a one-piece member;

the guide mechanism comprising a through slot; and

the at least one following element extending inwardly from the inner bearing surface of the outer member and into the through slot.

6. The front assembly of claim 4, wherein, an overall length of the front assembly is defined by an axial distance between the plane and the rear end of the front cap member, and said overall length is different in the first position than in the second position.

7. A front assembly having depth of penetration adjustment and being usable on a lancet device, comprising:

a cap member comprising a front end, a rear end, and a side wall having an outer bearing surface arranged between the front end and the rear end;

the rear end of the cap member being removably connectable to a body of the lancet device;

a slot arranged on the outer bearing surface and extending through the side wall of the cap member;

a stop surface adapted to be contacted by a lancet having a lancet needle;

the stop surface being positioned closer to the front end than to the rear end of the cap member;

an outer member comprising a skin engaging surface arranged in front of and spaced from the stop surface and defining a plane beyond which a tip of the lancet needle protrudes so as to define a depth of penetration;

an inner bearing surface structured and arranged to rotatably engage the outer bearing surface of the cap member;

an axial distance between the stop surface and the skin engaging surface changing when the outer member is rotated between at least a first position and a second position;

at least one following element extending into the slot;

the at least one following element movably engaging with the slot when the outer member moves between the first position and the second position; and

a least one tooth engaging different portions of a spline in the first position than in the second position,

wherein, when the front assembly is installed on the body of the lancet device, the lancet needle is capable of extending beyond the plane by a different amount in the first position than in the second position.

8. The front assembly of claim 7, wherein the outer member comprises indicating marks arranged on an outer surface and the cap member comprises a reference marker arrow.

9. A front assembly having depth of penetration adjustment and being usable on a lancet device, comprising:

a cap member comprising a front end, a rear end, and a side wall having an outer bearing surface arranged between the front end and the rear end;

the rear end of the cap member being removably connectable to a body of the lancet device;

a stop surface being adapted to be contacted by a lancet having a lancet needle;

a slot extending through the side wall and being arranged on the outer bearing surface of the cap member;

an outer member comprising a skin engaging surface arranged in front of and spaced from the stop surface and defining a plane beyond which a tip of the lancet needle protrudes so as to device a depth of penetration;

an inner bearing surface structured and arranged to rotatably engage the outer bearing surface of the cap member;

the outer member being rotatable between at least a first position and a second position;

at least one following element extending into the slot;

the at least one following element movably engaging with the slot when the outer member moves between the first position and the second position;

an axial distance between the stop surface and the skin engaging surface changing when the outer member is rotated between at least the first position and the second position; and

a least one tooth engaging different portions of an internal spline in the first position than in the second position,

wherein, when the front assembly is installed on the body of the lancet device, the lancet needle is capable of extending beyond the plane by a different amount in the first position than in the second position.

10. A front assembly having depth of penetration adjustment and being usable on a lancet device, comprising:

a cap member comprising a front end, a rear end, and a side wall having an outer bearing surface arranged between the front end and the rear end;

a stop surface being adapted to be contacted by a lancet having a lancet needle;

the rear end of the cap member being removably connectable via a snap engagement to a body of the lancet device;

a camming slot;

at least one following element extending into the camming slot;

an outer member having an overall axial length that is shorter than an overall axial length of the cap member;

the outer member comprising;

an inner bearing surface structured and arranged to rotatably engage the outer bearing surface of the cap member; and

a skin engaging surface arranged in front of and spaced from the stop surface and defining a plane beyond which a tip of a lancet needle protrudes so as to define a depth of penetration;

the skin engaging surface rotating relative to the stop surface when the space between the stop surface and the skin engaging surface changes;

the outer member being rotatable between at least a first position and a second position;

the at least one following element and the camming slot movably engaging each other when the outer member moves between the first position and the second position; and

a least one tooth engaging different portions of an internal spline in the first position than in the second position,

wherein, when the front assembly is installed on the body, the lancet needle is capable of extending beyond the plane by a different amount in the first position than in the second position.

11. The front assembly of claim 10, wherein the at least one following element extends out from the outer bearing surface.

12. The front assembly of claim 10, further comprising a recess extending into the inner bearing surface of the outer member.

13. The front assembly of claim 12, wherein the at least one following element extends into the recess.

14. The front assembly of claim 10, wherein the rear end has a polygonal cross-section and the snap engagement is formed between projections and recesses.

15. The front assembly of claim 10, wherein the outer member comprises indicating marks arranged on an outer surface and the cap member comprises a reference marker.

16. A front assembly having depth of penetration adjustment and being usable on a lancet device, comprising:

a cap member comprising a front end, a rear end, and a side wall having an outer bearing surface arranged between the front end and the rear end;

the rear end of the cap member being removably connectable to a body of the lancet device;

a slot arranged on the outer bearing surface and extending through the side wall of the cap member;

a stop surface adapted to be contacted by a lancet having a lancet needle;

the stop surface being positioned closer to the front end than to the rear end of the cap member;

an outer member comprising a skin engaging surface arranged in front of and spaced from the stop surface and defining a plane beyond which a tip of the lancet needle protrudes and defining the depth of penetration;

an inner bearing surface structured and arranged to rotatably engage the outer bearing surface of the cap member;

an axial distance between the stop surface and the skin engaging surface changing when the outer member is rotated between at least a first position and a second position;

at least one following element protruding inwardly from the inner bearing surface and extending into the slot;

the at least one following element movably engaging with the slot when the outer member moves between the first position and the second position; and

a least one tooth engaging different portions of an internal spline in the first position than in the second position,

wherein, when the front assembly is installed on the body of the lancet device, the lancet needle is capable of extending beyond the plane by a different amount in the first position than in the second position.

17. A front assembly having depth of penetration adjustment and being usable on a lancet device, comprising:

a cap member comprising a front end, a rear end, and a side wall having an outer bearing surface arranged between the front end and the rear end;

the rear end of the cap member being larger in cross-section that the front end and being removably connectable to a body of the lancet device;

a helical camming slot arranged on the outer bearing surface;

an outer member comprising;

a sidewall portion structured and arranged to rotate over the outer bearing surface of the cap member and having a grippable outer surface with grooves;

an opening allowing a tip of a lancet needle to pass therethrogh; and

a skin engaging surface defining a plane beyond which the tip of the lancet needle protrudes so as to define a depth of penetration;

at least one following element extending into the helical camming slot;

the at least one following element moving toward a first end of the helical camming slot when the outer member is rotated in a first direction;

the at least one following element moving toward a second end of the helical camming slot when the outer member is rotated in a second direction; and

a torque resistance mechanism utilizing a tooth that engages with different portions of a spline when the outer member is rotated relative to the cap member,

wherein, when the front assembly is installed on the body of the lancet device, the lancet needle is capable of extending beyond the plane by a different amount based on a rotational position of the outer member.

18. The front assembly of claim 17, wherein the different portions of the spline are integrally formed on the cap member.

19. The front assembly of claim 17, further comprising:

a stop surface adapted to be contacted by a lancet having the lancet needle and being located between the front and rear ends of the cap member; and

the stop surface being positioned closer to the front end than to the rear end of the cap member.

20. A front assembly having depth of penetration adjustment and being usable on a lancet device, comprising:

a cap member comprising a front end, a rear end, and a side wall having an outer bearing surface arranged between the front end and the rear end;

the rear end of the cap member being removably connectable to a body of the lancet device;

a stop cap comprising;

a camming slot extending through a sidewall of the stop cap; and

a stop surface adapted to be contacted by a lancet having a lancet needle;

an outer member comprising a skin engaging surface arranged in front of and spaced from the stop surface and defining a plane beyond which a tip of the lancet needle protrudes and defining the depth of penetration;

the outer member being rotatably mounted to the cap member;

an axial distance between the stop surface and the skin engaging surface changing when the outer member is rotated between at least a first position and a second position;

at least one following element extending into the camming slot;

the at least one following element movably engaging with the camming slot when the outer member moves between the first position and the second position; and

a least one tooth engaging different portions of an internal spline in the first position than in the second position,

wherein, when the front assembly is installed on the body of the lancet device, the lancet needle is capable of extending beyond the plane by a different amount in the first position than in the second position.

21. The front assembly of claim 20, wherein, when the outer member rotates relative to the cap member between the first and second positions, an overall axial length of the front assembly does not change.

22. The front assembly of claim 20, wherein the outer member comprises indicia and the cap member comprises an arrow indicator.

23. A front assembly having depth of penetration adjustment and being usable on a lancet device, comprising:

a cap member comprising a front end, a rear end, and a side wall having an outer bearing surface arranged between the front end and the rear end;

the rear end of the cap member being removably connectable to a body of the lancet device;

an axially adjustable stop cap comprising;

an opening allowing a lancet needle of a lancet to pass therethrough;

a camming slot extending through a sidewall of the stop cap; and

a stop surface adapted to be contacted by the lancet having the lancet needle;

an outer member comprising a skin engaging surface arranged in front of and spaced from the stop surface and defining a plane beyond which a tip of the lancet needle protrudes and defining the depth of penetration;

the outer member being rotatably mounted to the cap member and being prevented from moving axially when rotated;

an axial distance between the stop surface and the skin engaging surface changing when the outer member is rotated between at least a first position and a second position;

at least one following element extending into the camming slot;

the at least one following element movably engaging with the camming slot when the outer member moves between the first position and the second position; and

a least one tooth engaging different portions of an internal spline in the first position than in the second position,

wherein, when the front assembly is installed on the body of the lancet device, the lancet needle is capable of extending beyond the plane by a different amount in the first position than in the second position.

24. A front assembly having depth of penetration adjustment and being usable on a lancet device, comprising:

a cap member comprising a front end, a rear end, an internal spline and a camming slot;

the rear end of the cap member being removably connectable to a body of the lancet device;

a stop cap comprising;

at least one following element extending into the camming slot;

a stop surface adapted to be contacted by a lancet having a lancet needle;

at least one tooth engagable with different portions of the internal spline;

an outer member comprising a skin engaging surface arranged in front of and spaced from the stop surface and defining a plane beyond which a tip of the lancet needle protrudes and defining the depth of penetration;

the outer member being rotatably mounted to the cap member;

an axial distance between the stop surface and the skin engaging surface changing when the outer member is rotated between at least a first position and a second position; and

the at least one following element movably engaging with the camming slot when the outer member moves between the first position and the second position,

wherein, when the front assembly is installed on the body of the lancet device, the lancet needle is capable of extending beyond the plane by a different amount in the first position than in the second position.

25. The front assembly of claim 24, wherein, when the outer member rotates relative to the cap member between the first and second positions, an overall axial length of the front assembly does not change.

26. The front assembly of claim 24, wherein the outer member comprises indicia and the cap member comprises an arrow indicator.

27. A front assembly having depth of penetration adjustment and being usable on a lancet device, comprising:

a one-piece cap member comprising a front end, a rear end, a camming slot and an internal spline;

the rear end of the cap member being removably connectable to a body of the lancet device;

an axially adjustable one-piece stop cap comprising;

an opening allowing a lancet needle of a lancet to pass therethrough;

at least one following element extending into the camming slot;

a stop surface adapted to be contacted by the lancet having the lancet needle;

at least one tooth engagable with different portions of the internal spline;

an outer member comprising a skin engaging surface arranged in front of and spaced from the stop surface and defining a plane beyond which a tip of the lancet needle protrudes and defining the depth of penetration;

the outer member being rotatably mounted to the cap member and being prevented from moving axially when rotated; and

an axial distance between the stop surface and the skin engaging surface changing when the outer member is rotated between at least a first position and a second position,

wherein, when the front assembly is installed on the body of the lancet device, the lancet needle is capable of extending beyond the plane by a different amount in the first position than in the second position.

28. The front assembly of claim 27, wherein the at least one following element extends into a recess of the outer member.

29. The front assembly of claim 27, wherein the camming slot extends through a sidewall of the cap member.