Lancet system with a sterile protector

• US 8,083,760 B2
• Filed: 11/18/2007
• Issued: 12/27/2011
• 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
• Primary Examiner(s): Severson, Ryan
• Assistant Examiner(s): EASTWOOD, DAVID C
• Application Number:
  US11/941,951
• Publication Number:
  US 20080125801A1
• Time in Patent Office: 1,500 Days
• Field of Search: 600/573, 600/578, 600/583, 600/584, 604/136, 604/130, 604/111, 604/192, 604 87- 88, 606/181, 606/182, 606/183
• 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 first widening extending from a sharp lancet tip and at least one further widened portion, wherein the first widening and the further widened portion are separated by at least one section of a lancet shaft; and

a plastic member sealing the housing;

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

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

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

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

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

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

7. The lancet system of claim 1, wherein the radius of the first widening increases in a direction along the lancet away from the sharp lancet tip.

8. The lancet system of claim 1, wherein the plastic 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 sharp lancet tip and the first widening, 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 plastic 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 sharp lancet tip toward the plastic member.

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

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 first widening extending from a sharp lancet tip and at least one further widened portion, wherein the first widening and the further widened portion are separated by at least one section of a lancet shaft;

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

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

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

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

16. The lancet system of claim 13, wherein the plastic 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 further widened portion increases the size of the opening to be substantially greater than the size of the first widening.

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 plastic member.

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

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

21. A lancet system, comprising:

a housing;

a lancet reciprocably disposed in the housing, the lancet comprising a first widening extending from a sharp lancet tip and at least one further widened portion, wherein the first widening and the further widened portion are separated by at least one section of a lancet shaft;

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 plastic member seals the housing and the sharp lancet tip is surrounded by the housing; and

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

22. The lancet system of claim 21, wherein the further widened portion comprises a substantially conical shape.

23. The lancet system of claim 22, wherein the radius of the further widened portion increases in a direction along the lancet away from the sharp lancet tip.

24. The lancet system of claim 21, wherein the plastic member comprises at least one material selected from the group consisting of polyethylene, polypropylene, aluminum, tin, and polytetrafluoroethylene.

25. The lancet system of claim 21, wherein, after the puncture movement, the lancet retracts into the housing from the extended position to the retracted position, wherein the opening in the plastic member substantially maintains its shape and size.

26. The lancet system of claim 25, wherein, as the lancet retracts to the retracted position, the lancet does not contact the plastic member.

27. The lancet system of claim 21, wherein, during the puncture movement, the plastic member remains substantially intact.

28. The lancet system of claim 21, wherein, during the puncture movement, a portion of the plastic member pierced by the sharp lancet tip becomes flared.

29. The lancet system of claim 21, wherein, in the extended position, the size of the opening is defined by the further widened portion in contact with the plastic member.

30. The lancet system of claim 21, wherein the further widened portion enlarges the opening to a size that is substantially larger than the size of the first widening.