FLAT LANCET IMMOBILIZATION

• US 20090036797A1
• Filed: 09/11/2008
• Published: 02/05/2009
• Est. Priority Date: 03/02/2005
• Status: Active Grant

• Current Assignee: Roche Diabetes Care Inc. (Roche Holding AG)
• Original Assignee: Roche Diabetes Care Inc. (Roche Holding AG)
• Inventors: Roe, Steven N., Wong, Daniel, Raney, Charles C., Wiegel, Christopher, Chan, Frank A.
• Granted Patent: US 9,332,938 B2
• Time in Patent Office: Days
• US Class Current: 600/583
• CPC Class Codes: A61B 17/32093 for skin incisions
• CPC Class Codes: A61B 2010/0003 including means for analysis by an unskilled person
• CPC Class Codes: A61B 2562/0295 Strip shaped analyte sensors for apparatus classified in A61B5/145 or A61B5/157
• CPC Class Codes: A61B 5/1411 by percutaneous method, e.g. by lancet
• CPC Class Codes: A61B 5/14532 for measuring glucose, e.g. by tissue impedance measurement
• CPC Class Codes: A61B 5/1468 using chemical or electrochemical methods, e.g. by polarographic means A61B5/1486 takes precedence
• CPC Class Codes: A61B 5/150022 for capillary blood or interstitial fluid
• CPC Class Codes: A61B 5/150213 Venting means
• CPC Class Codes: A61B 5/150282 for piercing elements, e.g. blade, lancet, canula, needle
• CPC Class Codes: A61B 5/150358 Strips for collecting blood, e.g. absorbent optical reagent test strips G01N21/8483; chemical reagent test strips G01N33/4875, G01N33/52
• CPC Class Codes: A61B 5/150435 Specific design of proximal end
• 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 5/150809 by audible feedback
• CPC Class Codes: A61B 5/150816 by tactile feedback, e.g. vibration
• CPC Class Codes: A61B 5/150916 by blocking components, e.g. piston, driving device or fluid passageway
• CPC Class Codes: A61B 5/15142 Devices intended for single use, i.e. disposable
• CPC Class Codes: A61B 5/1519 comprising driving means, e.g. a spring, for propelling the piercing unit
• CPC Class Codes: A61B 5/157 Devices characterised by integrated means for measuring characteristics of blood

Abstract

A lancet enclosed in a sterility sheet forms a lancet packet to maintain the sterility of the lancet and prevent the lancet from unintentionally piercing the sterility sheet prior to lancet actuation. In one form, the lancet is immobilized by hot tack welding a portion of the sterility sheet to the lancet. Alternatively, portions of the sterility sheet are hot tack welded together through an opening in the lancet to limit movement of the lancet.

Claims

1. An integrated disposable, comprising:

a test sensor configured to analyze body fluid; and

a lancet packet coupled to the test sensor, the lancet packet including

a cover foil,

a lancet disposed inside the cover foil wherein the cover foil covers at least a lancet tip of the lancet, and

the cover foil including a hot tack weld configured to immobilize the lancet within the lancet packet.

2. The integrated disposable of claim 1, wherein the hot tack weld secures the cover foil to the lancet.

3. The integrated disposable of claim 1, wherein:

the lancet defines an opening; and

the hot tack weld attaches opposing sheets of the cover foil together through the opening in the lancet.

4. The integrated disposable of claim 1, further comprising:

a locking mechanism configured to retain the lancet within the lancet packet after the lancet is actuated.

5. The integrated disposable of claim 4, further comprising:

the hot tack weld being configured to immobilize the lancet prior to actuation of the lancet;

the locking mechanism including a spacer having an insertion portion; and

the lancet defining a keyway and the insertion portion of the spacer having a key shape sized to attach the lancet to the spacer after the lancet is actuated.

6. A method, comprising:

covering at least a lancet tip of a lancet with a cover foil to form a lancet packet; and

melting a portion of the cover foil to form a hot tack weld to immobilize the lancet.

7. The method of claim 6, further comprising:

forming an integrated disposable by coupling the lancet packet to a test element configured to analyze body fluid.

8. The method of claim 6, wherein the melting the portion of the cover foil includes laser welding the portion of the cover foil to the lancet to form the hot tack weld.

9. The method of claim 6, further comprising:

the hot tack weld being configured to immobilize the lancet prior to actuation of the lancet; and

forming a locking mechanism on the lancet that immobilizes the lancet after the lancet is actuated.

10. The method of claim 6, further comprising:

sterilizing the lancet; and

attaching the lancet packet to a test element to form an integrated disposable.

11. The method of claim 6, further comprising:

pinching together opposing sheets of the cover foil through an engagement opening of the lancet; and

wherein the melting the portion of the cover foil includes melting the pinched portions of the opposing sheets to form the hot tack weld.

12. An apparatus, comprising:

a key shaped member;

a lancet having a lancet tip and a lancet body, the lancet body defining a keyway; and

the lancet body keyed to the key shaped member to releasably lock the lancet to the key shaped member.

13. The apparatus of claim 12, further comprising:

the lancet and the key shaped member attached to a test element to form an integrated disposable.

14. The apparatus of claim 12, further comprising:

a cover foil being configured to cover at least the lancet tip, the cover foil including a hot tack weld configured to immobilize the lancet prior to actuation of the lancet; and

the lancet body keyed to the key shaped member to releasably lock the lancet to the key shaped member after actuation of the lancet.

15. A method, comprising:

releasing a lancet immobilized by a hot tack weld to a cover foil by breaking the hot tack weld.

16. The method of claim 15, further comprising:

the breaking the hot tack weld includes moving the lancet relative to the cover foil.

17. The method of claim 15, further comprising:

the breaking the hot tack weld includes piercing the cover foil at the hot tack weld with a firing mechanism.

18. The method of claim 15, further comprising:

analyzing a bodily fluid with a test sensor that is attached to the lancet to form an integrated disposable.

19. The method of claim 18, further comprising:

inserting the integrated disposable into a meter.

20. A method, comprising:

disengaging a lancet from a keyway shaped member for unimpeded movement of the lancet relative to the keyway shaped member, the lancet having an insertion portion shaped like a key and sized to mate with the keyway shaped member;

extending the lancet away from the keyway shaped member; and

re-engaging the insertion portion of the lancet with the keyway shaped member to immobilize the lancet relative to the keyway shaped member.

21. The method of claim 20, further comprising:

attaching a test element to the lancet to form an integrated disposable.