CAP ASSEMBLY FOR ALTERNATE SITE TESTING AND/OR UTILIZING A LOCKING SYSTEM AND/OR LOCKED DEPTH OF PENETRATION POSITIONS AND/OR LANCET DEVICE USING SUCH FEATURES

• US 20130053878A1
• Filed: 08/24/2012
• Published: 02/28/2013
• Est. Priority Date: 08/26/2011
• Status: Abandoned Application

• Current Assignee: Stat Medical Devices Incorporated
• Original Assignee: Stat Medical Devices Incorporated
• Inventors: SCHRAGA, Steven
• Application Number:
  US13/594,275
• Publication Number:
  US 20130053878A1
• 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 5/150183 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 5/150412 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 5/15117 comprising biased elements, resilient elements or a spring, e.g. a helical spring, leaf spring, or elastic strap
• CPC Class Codes: A61B 5/1519 comprising driving means, e.g. a spring, for propelling the piercing unit

Abstract

The invention provides for a lancet device and/or a cap assembly for a lancet device which includes a member capable of being removably mounted to a body of the lancet device. An alternate site testing (AST) cap can be mounted to the member. A method of using the lancet device includes mounting the member to a body of the lancet device, placing the alternate site testing (AST) cap against a skin surface, and forming a puncture in the skin surface with the needle. A method the lancet device includes mounting the member to a body of the lancet device and mounting the alternate site testing (AST) cap onto the member.

Claims

1. A lancet device comprising:

a cap assembly comprising;

a member capable of being removably mounted to a body of the lancet device; and

an alternate site testing (AST) cap mounted to the member; and

a lancet having a needle that is at least one of;

about 3.5 mm long; and

greater than 3.5 mm long.

2. The lancet device of claim 1, wherein the member comprises a stop surface adapted to be contacted by a front end of the lancet.

3. The lancet device of claim 1, wherein at least one of:

the AST cap is movable relative to the member between at least two axial positions and the at least two axial positions define different depth of penetrations of the needle;

the AST cap is movable relative to the member between plural axial positions; and

the AST cap is rotatable relative to the member between plural positions.

4. The lancet device of claim 1, wherein the lancet is removably mountable to a holding member of the lancet device.

5. The lancet device of claim 1, wherein the cap assembly utilizes depth of penetration adjustment.

6. The lancet device of claim 1, further comprising a second cap assembly adapted to be removably mounted to the body of the lancet device.

7. The lancet device of claim 6, wherein the second cap assembly utilizes depth of penetration adjustment.

8. The lancet device of claim 6, wherein the second cap assembly is a non-AST cap assembly.

9. The lancet device of claim 1, wherein the body of the lancet device utilizes depth of penetration adjustment.

10. The lancet device of claim 1, wherein the body comprises at least one of:

a stop surface for limiting forward travel of a lancet holding member movably arranged within the body; and

a stop surface for limiting forward travel of a lancet holding member movably arranged within the body.

11. The lancet device of claim 1, wherein the lancet device utilizes depth of penetration adjustment.

12. The lancet device of claim 11, wherein the depth of penetration adjustment is determined by a stop surface for limiting forward travel of a lancet holding member and a skin engaging surface of the AST cap.

13. The lancet device of claim 11, wherein the AST cap is adjustably movable between at least two depth of penetration positions, a first of the at least two depth of penetration positions being spaced from the stop surface by a lesser amount than a second of the at least two depth of penetration positions.

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

mounting the member to a body of the lancet device;

placing the alternate site testing (AST) cap against a skin surface; and

forming a puncture in the skin surface with the needle.

21. A method of making the lancet device of claim 1, the method comprising:

mounting the member to a body of the lancet device; and

mounting the alternate site testing (AST) cap onto the member.

14. A lancet device comprising:

a cap assembly one of;

comprising an alternate site testing (AST) cap and a non-AST cap each mountable to a member; and

two separate caps each being installable on the lancet device wherein one of the caps is an AST cap mounted to a member and another of the caps is a non-AST cap mounted to a member,

wherein the member is capable of being removably mounted to a body of the lancet device.

15. The lancet device of claim 14, further comprising a lancet having a needle that is more than 3.3 mm long.

16. The lancet device of claim 14, wherein the member comprises a stop surface adapted to be contacted by a front end of the lancet.

17. The lancet device of claim 14, wherein at least one of:

the AST cap is movable relative to the member between at least two axial positions and the at least two axial positions define different depth of penetrations of the needle;

the AST cap is movable relative to the member between plural axial positions; and

the AST cap is rotatable relative to the member between plural positions.

18. The lancet device of claim 14, wherein the lancet is removably mountable to a holding member of the lancet device and the cap assembly utilizes depth of penetration adjustment.

19. The lancet device of claim 14, wherein the body of the lancet device utilizes depth of penetration adjustment.

22. A cap assembly for a lancet device, the cap assembly comprising:

a member capable of being removably mounted to a body of the lancet device;

an alternate site testing (AST) cap capable of being mounted to the member; and

a non-AST cap capable of being mounted to the member.

23. The cap assembly of claim 22, further comprising a lancet having a needle that is more than 3.3 mm long.

24. A cap assembly for a lancet device comprising at least one of:

a member capable of being removably mounted to a body of the lancet device and a cap mounted to the member and moveble between at least two locked positions; and

at least one cap having at least two lockable depth of penetration adjustment positions.

25. A lancet device comprising at least one of:

a member capable of being removably mounted to the lancet device and a cap mounted to the member and moveble between at least two locked positions; and

a mechanism for locking a cap in at least two depth of penetration adjustment positions.

26. A cap assembly for a lancet device comprising at least one of:

a member capable of being removably mounted to a body of the lancet device and a cap mounted to the member and having at least the following modes of operation;

an adjusting mode allowing a user to at least one of;

adjust a depth of penetration position of a skin engaging surface of the cap;

change an axial distance between a skin engaging surface of the cap; and

move the cap between at least two depth of penetration positions; and

a locking mode wherein the user is prevented from adjusting the depth of penetration until the user places the cap in the unlocked position.

27. A lancet device comprising:

a member capable of being mounted to the lancet device and a cap mounted to the member; and

the cap being moveable between at least two depth of penetration positions when in an unlocked position and being prevented from moving between the at least two depth of penetration positions when in the locked position.

28. A lancet device with depth of penetration adjustment and being lockable in at least one depth of penetration position via a locking device.

29. A lancet device comprising at least the following modes of operation:

a mode wherein a skin engaging surface is automatically disposed in a position that prevents puncturing of a user'"'"'s skin when the lancet device is triggered; and

a mode wherein the skin engaging surface is disposed in a position that allows puncturing of a user'"'"'s skin when the lancet device is triggered.

30. A lancet device with depth of penetration adjustment comprising at least the following modes of operation:

a mode wherein a skin engaging surface is automatically disposed in a position that prevents puncturing of a user'"'"'s skin when the lancet device is triggered; and

a mode wherein the skin engaging surface is disposed in a position that allows puncturing of a user'"'"'s skin when the lancet device is triggered.

31. A lancet device comprising at least the following modes of operation:

a mode wherein the skin engaging surface is biased towards a position that prevents puncturing of a user'"'"'s skin when the lancet device is triggered; and

a mode wherein the skin engaging surface is movable to a position that allows puncturing of a user'"'"'s skin when the lancet device is triggered.

32. A lancet device comprising at least the following modes of operation:

a default mode wherein the skin engaging surface is in a position that prevents puncturing of a user'"'"'s skin when the lancet device is triggered; and

a puncturing mode wherein the skin engaging surface is selectively movable to a position that allows puncturing of a user'"'"'s skin when the lancet device is triggered.

33. A cap assembly for a lancet device comprising at least the following modes of operation:

a default mode wherein the skin engaging surface is in a position that prevents puncturing of a user'"'"'s skin when the lancet device is triggered; and

a puncturing mode wherein the skin engaging surface is selectively movable to a position that allows puncturing of a user'"'"'s skin when the lancet device is triggered.

34. The cap assembly of claim 33, further comprising at least one of:

an alternate site testing (AST) cap;

a non-AST cap;

a depth of penetration adjustment system; and

a locking system for locking the cap assembly in one of said modes of operation.