Lancet system with a sterile protector

• US 8,262,684 B2
• Filed: 11/14/2007
• Issued: 09/11/2012
• Est. Priority Date: 05/20/2005
• Status: Expired due to Fees

• Current Assignee: Roche Diabetes Care Inc. (Roche Holding AG)
• Original Assignee: Roche Diagnostics Operations Incorporated (Roche Holding AG)
• Inventors: List, Hans
• Primary Examiner(s): Severson, Ryan
• Assistant Examiner(s): EASTWOOD, DAVID C
• Application Number:
  US11/939,673
• Publication Number:
  US 20080125800A1
• Time in Patent Office: 1,763 Days
• Field of Search: 606/181, 606/182, 606/183, 604 59- 64, 604/136, 604/139, 600/573, 600/578, 600/583, 600/584
• US Class Current: 606/181
• CPC Class Codes: A61B 5/150022 for capillary blood or interstitial fluid
• 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 5/150572 Pierceable protectors, e.g. shields, caps, sleeves or films, e.g. for hygienic purposes
• 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

Abstract

The present invention provides a lancet system having a lancet tip protected by a sterile protector. The sterile protector includes a weakened portion near the tip end of the protector, which, during a puncturing operation, separates or tears in order to release the lancet tip. Other embodiments of the present invention include a pricking aid and/or lancet system provided as a magazine for holding a plurality of lancets. Each lancet of the plurality has a sterile protector as described above.

Claims

1. A lancet system for withdrawing body fluid from a body part, comprising:

a housing;

a lancet having a tip; and

a sterile protector that surrounds the tip, the sterile protector having a weakened portion that is brittle and is configured to undergo brittle fracture, the weakened portion of the sterile protector having a yield point of less than 50 N/mm2, the sterile protector at least partially separating along the weakened portion into sub-regions upon contact with the housing during a puncture movement, whereby the tip is released to perform a puncture.

2. The lancet system of claim 1, wherein the housing in which the lancet is reciprocably disposed has an opening through which the tip is exposed for puncture during a puncture movement of the lancet.

3. The lancet system of claim 2, wherein the tip extends from the opening during a puncture movement and retracts into the opening after the puncture movement.

4. The lancet system of claim 2, wherein the sterile protector at least partially separates when the sterile protector engages an inner surface of the housing.

5. The lancet system of claim 1, wherein the weakened portion comprises a thermoplastic, wax, or metal soap.

6. The lancet system of claim 5, wherein the weakened portion further comprises a filler selected from the group consisting of talc, graphite, and molybdenum disulfide.

7. The lancet system of claim 5, wherein the thermoplastic comprises polyethylene or polypropylene.

8. The lancet system of claim 1, wherein the weakened portion extends lengthwise along the sterile protector and is oriented substantially parallel to the tip.

9. The lancet system of claim 1, wherein the subregions protrude away from the tip after the sterile protector at least partially separates along the weakened portion.

10. The lancet system of claim 9, wherein the subregions remain connected to the sterile protector during the puncture movement.

11. The lancet system of claim 1, wherein the sterile protector comprises a substantially cylindrical cap.

12. The lancet system of claim 1, wherein the lancet defines a needle having the tip, the needle being at least partially surrounded by a lancet body.

13. The lancet system of claim 1, wherein the sterile protector is displaced away from the tip during the puncture movement.

14. The lancet system of claim 13, wherein the sterile protector slides along the lancet during the puncture movement.

15. The lancet system of claim 1, wherein the weakened portion comprises a plurality of weakened portions.

16. The lancet system of claim 1, wherein the weakened portion comprises a groove along which the sterile protector at least partially separates during a puncture movement.

35. The lancet system of claim 1, wherein the sterile protector separates along an annular edge thereof.

38. The lancet system of claim 1, wherein the separation comprises a tear disposed along the lengthwise direction of the sterile protector.

17. A lancet system for pricking a body part and withdrawing body fluid, comprising:

a magazine including a plurality of chambers; and

a plurality of lancets, one of the plurality of lancets being movably mounted in a respective one of the plurality of chambers, each lancet comprising;

a tip; and

a sterile protector that surrounds the tip, the sterile protector having a weakened portion that is brittle and is configured to undergo brittle fracture, the weakened portion of the sterile protector having a yield point of less than 50 N/ram2, the sterile protector at least partially separating along the weakened portion into sub-regions upon contact with the chamber during a puncture movement, whereby the tip is released to perform a puncture.

18. The lancet system of claim 17, wherein each chamber includes a first opening configured for receiving a driving actuator.

19. The lancet system of claim 17, wherein, during a puncture movement, the sterile protector engages an inner surface of the chamber, thereby causing the sterile protector to at least partially separate at the weakened portion.

20. The lancet system of claim 17, wherein each chamber includes an outlet through which the tip extends during a puncture movement and through which the tip retracts into the chamber after the puncture movement.

21. The lancet system of claim 17, wherein the subregions protrude away from the tip after the sterile protector at least partially separates along the weakened portion.

22. The lancet system of claim 21, wherein the subregions remain connected to the sterile protector during the puncture movement.

23. The lancet system of claim 17, wherein the sterile protector is displaced away from the tip during the puncture movement.

24. The lancet system of claim 23, wherein the sterile protector slides along the lancet during the puncture movement.

36. The lancet system of claim 17, wherein the sterile protector separates along an annular edge thereof.

39. The lancet system of claim 17, wherein the separation comprises a tear disposed along the lengthwise direction of the sterile protector.

25. A lancet system, comprising:

a housing having an opening;

a lancet disposed in the housing and having a tip configured to puncture a body part during a puncturing operation;

a sterile protector having a weakened portion that is brittle and is configured to undergo brittle fracture, the weakened portion of the sterile protector having a yield point of less than 50 N/mm2; and

the lancet being moveable between a first position and a second position, in the first position the tip being positioned within the housing and enclosed by the sterile protector, and in the second position the tip being exposed through the opening and the sterile protector being at least partially separated into sub-regions along the weakened portion upon contact with the housing.

26. The lancet system of claim 25, wherein the sterile protector comprises a substantially cylindrical cap.

27. The lancet system of claim 25, wherein the sterile protector comprises a first end section and a second end section, the second end section including the weakened portion.

28. The lancet system of claim 27, wherein, in the second position, the first end section circumscribes the lancet.

29. The lancet system of claim 27, wherein, in the second position, the second end section remains attached to the first end section.

30. The lancet system of claim 27, wherein, as the tip moves from the first position to the second position, the second end section engages an inner surface of the housing and at least partially separates along the weakened portion.

31. The lancet system of claim 30, wherein, as the second end section at least partially separates along the weakened portion, the second end section divides into the subregions, the subregions protruding away from the tip.

32. The lancet system of claim 30, wherein, after the second end section engages the inner surface of the housing, the sterile protector moves relative to the tip.

33. The lancet system of claim 32, wherein the sterile protector slides relative to the tip.

34. The lancet system of claim 25, wherein, in the second position, the subregions protrude away from the tip.

37. The lancet system of claim 25, wherein the sterile protector separates along an annular edge thereof.

40. The lancet system of claim 25, wherein the separation comprises a tear disposed along the lengthwise direction of the sterile protector.