LANCET SYSTEM WITH A STERILE PROTECTOR

• US 20080125801A1
• Filed: 11/18/2007
• Published: 05/29/2008
• Est. Priority Date: 05/20/2005
• Status: Active Grant

• Current Assignee: Roche Diabetes Care Inc. (Roche Holding AG)
• Original Assignee: Roche Diagnostics Operations Incorporated (Roche Holding AG)
• Inventors: List, Hans
• Granted Patent: US 8,083,760 B2
• 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 5/150412 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, a lancet body, and an outer body or housing which surrounds the lancet tip and in which the lancet tip is movable. The outer body or housing comprises deformable material which can be pierced by the lancet tip during a puncture operation to produce an outlet opening. The outlet opening can be widened during the puncture operation by a thickened or widened portion of the lancet body that at least partially protrudes through the opening. Other embodiments of the present invention include a pricking aid and/or lancet system provided as a magazine for holding a plurality of lancets.

Claims

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

a housing;

a lancet reciprocably disposed in the housing, the lancet comprising a widened portion and a tip; and

a deformable member sealing the housing;

wherein, during a puncture movement of the lancet, the tip pierces the deformable member to produce an opening through which the tip then extends for puncturing a body part, the widened portion contacting the deformable member during the puncture movement and thereby enlarging the opening.

2. The lancet system of claim 1, wherein, after the puncture movement, the tip retracts into the housing, the opening in the deformable member substantially maintaining its shape after the retraction.

3. The lancet system of claim 1, wherein, during the puncture movement, the deformable member remains substantially intact.

4. The lancet system of claim 1, wherein, during the puncture movement, the portion of the deformable member pierced by the tip becomes flared.

5. The lancet system of claim 1, wherein the widened portion comprises a substantially conical shape.

6. The lancet system of claim 5, wherein the radius of the widened portion increases in a direction along the lancet away from the tip.

7. The lancet system of claim 1, wherein the widened portion is positioned adjacent to the tip.

8. The lancet system of claim 1, wherein the deformable member comprises at least one material selected from the group consisting of polyethylene, polypropylene, aluminum, tin, and polytetrafluoroethylene.

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

10. The lancet system of claim 1, wherein the housing comprises a first end and a second end, the first end including a first film and the second end including the deformable member.

11. The lancet system of claim 10, wherein the first film is configured to be pierced by an actuator and the lancet is adapted to be driven by the actuator during the puncture movement, thereby moving the tip toward the deformable member.

12. The lancet system of claim 1, wherein, during the puncture movement, the widened portion enlarges the opening to a size that is substantially larger than the size of the tip.

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

a magazine including a plurality of chambers;

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

a plurality of deformable members, each one of the plurality of deformable members sealing a respective one of the plurality of chambers; and

wherein, during a puncture movement of one of the plurality of lancets, the tip of the one lancet pierces the respective deformable member to produce an opening through which the tip then extends for puncturing a body part, the widened portion contacting the respective deformable member during the puncture movement and thereby enlarging the opening.

14. The lancet system of claim 13, wherein, during the puncture movement, the deformable member remains substantially intact.

15. The lancet system of claim 13, wherein, during the puncture movement, the portion of the deform able member pierced by the tip becomes flared.

16. The lancet system of claim 13, wherein the deformable member comprises at least one material selected from the group consisting of polyethylene, polypropylene, aluminum, tin, and polytetrafluoroethylene.

17. The lancet system of claim 13, wherein the widened portion increases the size of the opening to be substantially greater than the size of the tip.

18. The lancet system of claim 13, wherein each chamber comprises a first end and a second end, the first end including a first film and the second end including the deformable member.

19. The lancet system of claim 13, wherein, after the puncture movement, the tip retracts into the housing, wherein the opening in the deformable member substantially maintains its shape.

20. The lancet system of claim 19, wherein, after the tip retracts into the respective chamber, the size and shape of the opening remain substantially the same.

21. A method for pricking a body part with a lancet system comprising a housing having a deformable member and a lancet movably disposed in the housing, the lancet having a tip and a widened portion, the method comprising:

positioning the deformable member of the housing on or near the body part;

moving the lancet toward the deformable member during a puncture movement;

piercing an opening in the deformable member with the tip;

contacting the widened portion with the opening, thereby enlarging the opening; and

puncturing the body part.

22. The method of claim 21, further comprising maintaining the shape of the opening after the puncture movement.

23. The method of claim 21, further comprising maintaining the deformable member intact during the puncture movement.

24. The method of claim 21, wherein, during the puncture movement, the portion of the deformable member pierced by the tip becomes flared.

25. The method of claim 21, further comprising retracting the tip into the housing, wherein the lancet does not contact the deformable member during the retraction.

26. The method of claim 21, further comprising substantially maintaining the size and shape of the opening after the puncture movement.

27. The method of claim 21, wherein, after the puncture movement, the width of the opening is substantially larger than the width of the tip.

28. The method of claim 21, wherein, before the piercing step, the tip is surrounded by the housing.

29. The method of claim 21, further comprising a subsequent puncture movement in which the tip is driven through the opening, wherein the tip does not contact the deformable member during the subsequent puncture movement.

30. A lancet system, comprising:

a housing;

a lancet reciprocably disposed in the housing, the lancet comprising a widened portion and a tip;

the lancet being movable between a retracted position and an extended position during a puncture movement;

wherein, in the retracted position of the lancet, a deformable member seals the housing and the tip is surrounded by the housing, and

further wherein, in the extended position of the lancet, the tip extends through an opening in the deformable member that is created when the tip pierces the deformable member during the puncture movement, the widened portion contacting the deformable member and defining the size of the opening in the extended position.

31. The lancet system of claim 30, wherein the widened portion comprises a substantially conical shape.

32. The lancet system of claim 31, wherein the radius of the widened portion increases in a direction along the lancet away from the tip.

33. The lancet system of claim 30, wherein the deformable member comprises at least one material selected from the group consisting of polyethylene, polypropylene, aluminum, tin, and polytetrafluoroethylene.

34. The lancet system of claim 30, wherein, after the puncture movement, the lancet retracts into the housing from the extended position to the retracted position, wherein the opening in the deformable member substantially maintains its shape and size.

35. The lancet system of claim 34, wherein, as the lancet retracts to the retracted position, the lancet does not contact the deformable member.

36. The lancet system of claim 30, wherein, during the puncture movement, the deformable member remains substantially intact.

37. The lancet system of claim 30, wherein, during the puncture movement, the portion of the deformable member pierced by the tip becomes flared.

38. The lancet system of claim 30, wherein, in the extended position, the size of the opening is defined by the widened portion in contact with the deformable member.

39. The lancet system of claim 30, wherein the widened portion enlarges the opening to a size that is substantially larger than the size of the tip.