System and method for breaking a sterility seal to engage a lancet

• US 7,935,063 B2
• Filed: 10/20/2006
• Issued: 05/03/2011
• Est. Priority Date: 03/02/2005
• Status: Expired due to Fees

• Current Assignee: Roche Diabetes Care Inc. (Roche Holding AG)
• Original Assignee: Roche Diagnostics Operations Incorporated (Roche Holding AG)
• Inventors: Roe, Steven N.
• Primary Examiner(s): Hindenburg; Max
• Assistant Examiner(s): SMITH, FANGEMONIQUE A
• Application Number:
  US11/551,414
• Publication Number:
  US 20070167869A1
• Time in Patent Office: 1,656 Days
• Field of Search: 600/584, 600/585, 600/583, 600/573, 600/345, 606/181, 606/182
• US Class Current: 600/584
• 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, wherein the engagement opening is in 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;

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; and

wherein the lancet is sealed inside a sterility sheet to form a lancet packet.

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 one or more cut out portions have a circular shape.

5. The apparatus of claim 4, wherein the engagement opening has a recessed section that is diamond shaped.

6. The apparatus of claim 5, wherein:

the engagement blade has two of the cutting edges; and

the engagement opening has two of the circular shaped cut out portions that are disposed on opposite ends of the diamond shaped recessed section.

7. The apparatus of claim 1, wherein the one or more cutting edges of the engagement blade are configured to cut one or more slits in the sterility sheet of the lancet packet to promote smooth actuation of the lancet.

8. 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.

9. The apparatus of claim 8, wherein the firing mechanism is configured to puncture the sterility sheet with the tip of the blade during firing of the lancet.

10. The apparatus of claim 9, 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.

11. The apparatus of claim 1, further comprising a test strip attached to the lancet packet.

12. The apparatus of claim 1, wherein the lancet defines a capillary groove configured to draw body fluid via capillary action.

42. The apparatus of claim 1, wherein the engagement blade of the firing mechanism is configured to pierce the sterility sheet of the lancet packet.

13. An apparatus, comprising:

a lancet defining an engagement opening where the lancet is coupled to a firing mechanism, wherein the engagement opening is in the lancet; and

wherein the engagement opening is shaped like a rounded diamond with circular cut outs at opposite ends of the diamond.

14. The apparatus of claim 13, further comprising a test strip coupled to the lancet to analyze a body fluid sample.

15. The apparatus of claim 14, further comprising a lancet packet in which the lancet is sealed inside in a sterile manner.

16. The apparatus of claim 13, wherein the lancet defines a capillary groove configured to draw a body fluid sample via capillary action.

17. An apparatus, comprising:

a firing mechanism configured to fire a lancet that is sealed inside a lancet packet for cutting an incision in skin; and

the firing mechanism including

an engagement blade configured to engage the lancet,

the engagement blade having a cutting edge positioned to cut a slit in the lancet packet for facilitating smooth actuation of the lancet;

wherein the firing mechanism is configured to retract the lancet; and

wherein the engagement blade includes a second cutting edge positioned to form a second slit in the lancet packet as the engagement blade retracts the lancet.

18. The apparatus of claim 17, further comprising:

the lancet;

the lancet packet;

a test strip attached to the lancet packet; and

the firing mechanism being configured to pierce the lancet packet with the blade and cut the slit during firing of the lancet to minimize cross-contamination between the lancet and the test strip.

19. The apparatus of claim 17, wherein the firing mechanism is configured to cut the slit during priming to conserve energy for firing of the lancet.

20. The apparatus of claim 17, wherein the firing mechanism is configured to cut the slit during loading of the lancet.

21. The apparatus of claim 17, further comprising:

the lancet;

the lancet packet; and

the lancet defining an engagement opening in which the engagement blade is received, the engagement opening being shaped like a rounded diamond with circular cut outs at opposite ends of the diamond to reduce dulling of the cutting edge of the blade.

22. An apparatus, comprising:

a lancet sealed inside a lancet packet to maintain sterility of the lancet;

a test strip attached to the lancet packet;

a firing mechanism including an engagement blade configured to engage with the lancet, the firing mechanism being configured to pierce the lancet packet with the blade;

wherein the lancet has an engagement opening in which the engagement blade is received; and

wherein the test strip has a relief slot configured to receive at least a portion of the engagement blade when engaged with the engagement opening of the lancet.

23. The apparatus of claim 22, wherein:

the engagement opening is shaped like a rounded diamond with circular cut outs at opposite ends of the diamond to reduce dulling of the blade.

24. The apparatus of claim 22, wherein the firing mechanism is configured to pierce the lancet packet during firing of the lancet to minimize cross-contamination between the lancet and the test strip.

25. The apparatus of claim 22, wherein the firing mechanism is configured to pierce the lancet packet during priming to cut a travel path in the lancet packet for the blade.

26. A method, comprising:

engaging a blade of a firing mechanism with a lancet that is enclosed inside a packet, wherein the blade includes a first cutting edge and a second cutting edge;

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

forming a slit in the packet with the first cutting edge of the blade, wherein said forming the slit in the packet occurs during said firing; and

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

27. The method of claim 26, further comprising:

reducing dulling of the blade by providing an engagement opening that is shaped like a rounded diamond with circular cut outs at opposite ends of the diamond; and

inserting the blade into the engagement opening.

28. The method of claim 26, further comprising:

priming the firing mechanism; and

forming the slit in the packet during said priming.

29. The method of claim 26, further comprising:

loading the packet into the firing mechanism; and

forming the slit in the packet during said loading.

30. The method of claim 26, wherein said engaging the blade occurs before forming the slit in the packet.

31. The method of claim 26, wherein said engaging the blade occurs after forming the slit in the packet.

32. The method of claim 26, further comprising:

wherein the packet is attached to a test strip;

forming an incision in the skin with the lancet; and

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

33. A method, comprising:

loading a lancet integrated test strip into a meter that includes a firing mechanism, wherein the lancet integrated test strip includes a lancet sealed inside a lancet packet and a test strip attached to the lancet packet, wherein the firing mechanism includes a blade that has a cutting edge;

reducing cross-contamination risk between the lancet and the test strip by piercing the lancet packet after said loading the lancet integrated test strip;

engaging the blade of the firing mechanism into an engagement opening that has a cut out portion positioned proximal the cutting edge of the blade to reduce dulling of the cutting edge;

firing the lancet with the firing mechanism to cut an incision in skin;

slitting the lancet packet with the cutting edge of the blade during said firing; and

analyzing a body fluid sample from the incision with the test strip.

34. The method of claim 33, further comprising:

priming the firing mechanism;

wherein the firing mechanism includes a blade; and

wherein said slitting the lancet packet occurs during said priming.

35. A method, comprising:

inserting an engagement blade of a firing mechanism inside an engagement opening in a lancet, wherein the lancet is sandwiched to a test strip that has a relief slot;

wherein said inserting the engagement blade includes receiving at least a portion of the engagement blade in the relief slot of the test strip;

firing the lancet by actuating the engagement blade of the firing mechanism; and

wherein the portion of the engagement blade received in the relief slot travels inside the relief slot during said firing of the lancet.

36. The method of claim 35, further comprising:

wherein the lancet is enclosed inside a lancet packet that maintains lancet sterility; and

slitting the lancet packet with the engagement blade.

37. The method of claim 36, further comprising:

loading the lancet packet into the firing mechanism; and

wherein said slitting the lancet packet occurs during said loading.

38. The method of claim 36, further comprising:

wherein said slitting the lancet packet occurs during said firing.

39. The method of claim 36, further comprising:

priming the firing mechanism; and

wherein said slitting the lancet packet occurs during said priming.

40. The method of claim 36, further comprising:

wherein the engagement blade includes first and second cutting edges; and

forming a second slit in the lancet packet with the second cutting edge of the engagement blade by retracting the lancet after said firing.

41. The method of claim 40, further comprising:

wherein the engagement opening is shaped like a rounded diamond with circular cut outs at opposite ends of the diamond; and

reducing dulling of the engagement blade by aligning the first and second cutting edges in the circular cut outs of the engagement opening during said inserting the engagement blade.