SYSTEM AND METHOD FOR BREAKING A STERILITY SEAL TO ENGAGE A LANCET

• US 20110178435A1
• Filed: 03/29/2011
• Published: 07/21/2011
• Est. Priority Date: 03/02/2005
• Status: Abandoned Application

• Current Assignee: Roche Diabetes Care Inc. (Roche Holding AG)
• Original Assignee: Roche Diabetes Care Inc. (Roche Holding AG)
• Inventors: Roe, Steven N.
• Application Number:
  US13/074,620
• Publication Number:
  US 20110178435A1
• Time in Patent Office: Days
• US Class Current: 600/583
• CPC Class Codes: A61B 5/14532 for measuring glucose, e.g. by tissue impedance measurement
• CPC Class Codes: A61B 5/150022 for capillary blood or interstitial fluid
• CPC Class Codes: A61B 5/150068 by tissue compression, e.g. with specially designed surface of device contacting the skin area to be pierced
• 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 5/150213 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 5/150465 Specific design of proximal end
• CPC Class Codes: A61B 5/150633 Protective sleeves which are axially extensible, e.g. sleeves connected to, or integrated in, the piercing or driving device; pivotable protective sleeves
• CPC Class Codes: A61B 5/150702 fully automatically removed, i.e. the removing does not require any 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 5/15117 comprising biased elements, resilient elements or a spring, e.g. a helical spring, leaf spring, or elastic strap
• 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
• CPC Class Codes: A61B 5/157 Devices characterised by integrated means for measuring characteristics of blood

Abstract

An integrated lancing test strip includes a test strip and a lancet packet coupled to the test strip. The lancet packet includes a sterility sheet enclosing a lancet to maintain the sterility of the lancet and prevent cross-contamination between the test strip and the lancet. The sterility sheet allows the lancet to be sterilized separately from the test strip. In one form, a firing mechanism has a blade that punctures and slits the sterility sheet during the firing cycle to reduce the chance of cross contamination between the lancet and the test strip prior to use. This allows an operator to load and subsequently remove an unused integrated lancing test strip without compromising the sterility of the lancet. The lancet includes an engagement opening in which the blade of the firing mechanism engages the lancet. The engagement opening is configured to reduce the chance of the blade becoming dull.

Claims

1. An apparatus, comprising:

a lancet defining an engagement opening;

a sterility sheet configured to maintain sterility of the lancet;

a firing mechanism to fire the lancet, the firing mechanism including an engagement blade that is configured to engage with the engagement opening of the lancet, the engagement blade having one or more cutting edges configured to slit the sterility sheet; and

the engagement opening having one or more cut out portions at the one or more cutting edges when the blade engages the engagement opening to minimize dulling of the one or more cutting edges of the engagement blade.

2. The apparatus of claim 1, wherein the engagement opening of the lancet has one or more engagement protrusions configured to contact the blade at a location other than at the one or more cutting edges.

3. The apparatus of claim 2, wherein the one or more engagement protrusions are rounded to prevent damage to the blade.

4. The apparatus of claim 1, wherein the engagement opening is shaped like a rounded diamond with circular cut outs at opposite ends of the diamond.

5. The apparatus of claim 1, wherein the engagement blade of the firing mechanism has a tip configured to puncture the sterility sheet during engagement with the engagement opening of the lancet.

6. The apparatus of claim 5, wherein the firing mechanism includes:

a firing arm secured to the engagement blade, the firing arm including one or more cam pins;

a plunger defining one or more cam slots in which the one or more cam pins are slidably received; and

wherein the one or more cam slots are shaped to move the engagement blade to puncture the sterility sheet with the tip of the blade when the plunger is fired.

7. The apparatus of claim 1, further comprising:

wherein the sterility sheet forms a lancet packet; and

a test strip attached to the lancet packet to form a lancet integrated test strip.

8. The apparatus of claim 7, wherein the test strip includes a slot positioned to receive at least a portion of the engagement blade of the firing mechanism.

9. The apparatus of claim 7, further comprising:

wherein the lancet is received inside a guide slot of a guide member; and

wherein the sterility sheet is folded to form two flaps that are sealed with the guide member to form the lancet packet.

10. The apparatus of claim 1, wherein the lancet is a micro-sampler with a capillary groove configured to draw body fluid via capillary action.

11. A method, comprising:

piercing a sterility sheet with a blade of a firing mechanism that includes a cutting edge;

engaging the blade of the firing mechanism with an engagement opening in a lancet, wherein the engagement opening has a cut out portion; and

wherein said engaging includes reducing dulling of the cutting edge of the blade by positioning the cutting edge inside the cut out portion of the engagement opening where the cutting edge remains out contact with the lancet.

12. The method of claim 11, further comprising:

wherein the engagement opening of the lancet has opposing engagement protrusions; and

wherein said engaging the blade includes contacting the engagement protrusions to the blade at locations other than at the cutting edge.

13. The method of claim 11, wherein the engagement opening is shaped like a rounded diamond with circular cut outs at opposite ends of the diamond.

14. The method of claim 11, further comprising:

firing the lancet with the firing mechanism by advancing the lancet with the blade to form an incision in skin; and

wherein said firing the lancet includes forming a slit in the sterility sheet with the cutting edge during said firing.

15. The method of claim 14, further comprising:

wherein the blade includes a second cutting edge; and

forming a second slit in the sterility sheet with the second cutting edge of the blade by retracting the lancet with the blade after forming the incision.

16. The method of claim 11, further comprising:

priming the firing mechanism; and

forming a slit in the sterility sheet with the cutting edge during said priming.

17. The method of claim 11, further comprising:

loading the packet into the firing mechanism; and

forming a slit in the packet during said loading.

18. The method of claim 11, further comprising:

wherein the sterility sheet forms a lancet packet around the lancet;

wherein the lancet packet is attached to a test strip;

forming an incision in skin with the lancet; and

analyzing body fluid from the incision in the skin with the test strip.

19. The method of claim 18, further comprising:

wherein the test strip includes a slot; and

wherein said engaging the blade includes inserting at least a portion of the blade of the firing mechanism into the slot in the test strip.

20. The method of claim 11, wherein the lancet is a micro-sampler with a capillary groove configured to draw body fluid via capillary action.