Lancing aid comprising a lancet system that is protected against re-use

• US 7,785,338 B2
• Filed: 03/22/2004
• Issued: 08/31/2010
• Est. Priority Date: 03/20/2003
• Status: Active Grant

• Current Assignee: Roche Diabetes Care Inc. (Roche Holding AG)
• Original Assignee: Roche Diagnostics Corporation (Roche Holding AG)
• Inventors: Weiss, Thomas, Forster, Richard, Sachsenweger, Peter, Ebert, Karl-Peter, Kuhr, Hans-Juergen
• Primary Examiner(s): Nguyen; Anhtuan T
• Assistant Examiner(s): Lang; Amy T
• Application Number:
  US10/806,483
• Publication Number:
  US 20040260325A1
• Time in Patent Office: 2,353 Days
• Field of Search: 606/181, 606/182, 606/183, 606/185, 606/167, 604/197, 604/198, 761/19, 600/583, 791/19
• US Class Current: 606/181
• CPC Class Codes: A61B 5/150022 for capillary blood or interstitial fluid
• CPC Class Codes: A61B 5/150259 Improved gripping, e.g. with high friction pattern or projections on the housing surface or an ergonometric shape
• 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 5/150702 fully automatically removed, i.e. the removing does not require any action by the user
• CPC Class Codes: A61B 5/150916 by blocking components, e.g. piston, driving device or fluid passageway
• CPC Class Codes: A61B 5/15142 Devices intended for single use, i.e. disposable
• CPC Class Codes: A61B 5/15146 Devices loaded with multiple lancets simultaneously, e.g. for serial firing without reloading, for example by use of stocking means. multiple simultaneous cutting or piercing A61B5/150977
• CPC Class Codes: A61B 5/15155 Piercing elements which are specially shaped or are provided with fittings or attachments to facilitate nesting, stacking or joining together end-to-end or side-by-side
• CPC Class Codes: A61B 5/15169 Characterized by a rolled strip
• CPC Class Codes: A61B 5/15171 Characterized by propelling the piercing element perpendicular to the direction of movement of the strip
• CPC Class Codes: A61B 5/15176 Stocking means comprising cap, cover, sheath or protection for aseptic stocking

Abstract

The present invention is generally directed towards the field of lancing aids in which disposable lancet systems are used. The lancet system according to the invention has a needle body which surrounds the needle tip in a lancet system in a protective manner and also comprises a protection against re-use of an ejected lancet system.

Claims

1. A multiple use lancing aid for producing an opening in the skin, the lancing aid comprising:

a lancing aid housing for inserting a removable lancet system, wherein the lancing aid housing has a holding element that interacts with a holding element in the lancet system when the lancet system is positioned in the lancing aid housing;

the lancet system comprising at least one needle having a needle tip and a needle housing, wherein the at least one needle is movably connected to the needle housing, wherein the needle housing comprises a protective portion such that the protective portion of the needle housing and the needle can be moved relative to one another;

wherein the protective portion of the needle housing partially surrounds the needle tip in a first position;

wherein the protective portion of the needle housing and the needle tip are arranged relative to one another in a second position in such a manner that the needle tip extends from the protective portion of the needle housing;

an opening in the lancing aid housing, wherein the needle tip of the at least one needle can emerge from the lancing aid housing during a lancing operation; and

a blocking mechanism comprised in the needle housing, wherein the blocking mechanism is actuated by an interaction with the lancing aid housing such that after removal of the lancet system from the lancing aid housing, the holding element of the lancing aid housing is prevented from interacting with the holding element of the lancet system, and reuse of the lancet system with the lancing aid after the lancet system is removed from the lancing aid is thereby prevented.

2. The lancing aid as claimed in claim 1, wherein the holding element of the lancing aid housing is prevented from interacting with the holding element of the lancet system in such a manner that after removal from the lancing aid housing, the lancet system cannot be reinserted into the lancing aid housing.

3. The lancing aid as claimed in claim 1, wherein the lancet system and the lancing aid housing each have several, and independently acting holding elements.

4. The lancing aid as claimed in claim 1, wherein the actuation of the blocking mechanism prevents an interaction of the holding elements of the lancet system with the lancing aid housing such that the lancet system can not be held and positioned in the lancing aid housing after it is removed.

5. The lancing aid as claimed in claim 1, wherein an interaction of the holding elements of the lancing aid housing and the lancet system is prevented in such a manner that the needle cannot be propelled.

6. The lancing aid as claimed in claim 1, wherein the actuation of the blocking mechanism spatially separates the holding elements when the lancet system is reinserted into the lancing aid housing.

7. The lancing aid as claimed in claim 1, wherein the blocking mechanism is actuated when the lancet system is removed from the lancing aid housing.

8. The lancing aid as claimed in claim 1, wherein the blocking mechanism is actuated when the lancet system is inserted into the lancing aid housing.

9. The lancing aid as claimed in claim 1, wherein the blocking mechanism is actuated during a lancing operation.

10. The lancing aid as claimed in claim 1, wherein the protective portion of the needle housing and the needle tip are moved relative to one another to the first position during the removal of the lancet system from the lancing aid housing.

11. The lancing aid as claimed in claim 1, wherein the first position of the protective portion of the needle housing is the same as the resting position.

12. A lancet system for insertion into a lancing aid, the lancet system comprising:

at least one needle with a tip for producing a skin opening;

a needle housing comprising a holding element that interacts with a holding element of the lancing aid when the lancet system is inserted into the lancing aid, wherein the needle housing is movably connected to the needle in such a manner that at least one protective portion of the needle housing and the needle can be moved relative to one another;

wherein the protective portion of the needle housing at least partially surrounds the needle tip in a first position and in a second position, the protective portion of the needle housing and the needle tip are spatially separated from one another such that the needle tip extends from the protective portion of the needle housing, the protective portion of the needle housing being positioned in the first position when the lancet system is removed from the lancing aid; and

the needle housing comprising a blocking mechanism movably connected thereto, wherein the blocking mechanism is actuated by an interaction with the lancing aid and wherein the actuation moves the blocking mechanism relative to the needle housing and changes the shape of the needle housing such that, after removal of the lancet system from the lancing aid, the holding element is prevented from interacting with the holding element of the lancing aid, wherein reuse of the lancet system with the lancing aid after the lancet system is removed from the lancing aid is prevented.

13. The lancet system as claimed in claim 12, wherein the actuation of the blocking mechanism changes the shape of the needle housing.

14. The lancet system as claimed in claim 12, wherein the needle housing comprises a magazine housing that contains a plurality of needles.

15. The lancet system as claimed in claim 12, wherein the blocking mechanism is actuated independently of the protective portion of the needle housing and the needle moving relative to one another.

16. The lancet system as claimed in claim 12, wherein the actuation of the blocking mechanism covers the holding element of the lancet system.

17. The lancet system as claimed in claim 12, wherein the shape of the needle housing comprises the holding element of the lancet system.

18. The lancet system as claimed in claim 12, wherein the actuation of the blocking mechanism breaks the needle housing when it is removed from the lancing aid.

19. The lancet system as claimed in claim 12, wherein the actuation of the blocking mechanism enlarges at least one area of the needle housing.

20. The lancet system as claimed in claim 12, wherein the actuation of the blocking mechanism reduces the size of at least one area of the needle housing.

40. The lancet system of claim 12, wherein actuation of the blocking mechanism uncovers or covers the holding element of the needle housing.

41. The lancet system of claim 12, wherein the holding element of the needle housing comprises a flexible arm member.

21. A lancing aid, comprising:

a lancing aid housing;

a needle housing configured for insertion into the lancing aid housing and removal therefrom after use;

a needle movably mounted to the needle housing, the needle having a tip for producing a skin opening;

the needle being movable from a first resting position in which the needle housing at least partially surrounds the tip, to a lancing position in which the tip is exposed for puncturing a body part, and to a second resting position in which the needle housing at least partially surrounds the tip, the needle occupying the second resting position when the needle housing is removed from the lancing aid housing;

the needle being movable to and from the lancing position multiple times after the needle housing is inserted into the lancing aid housing and before removal therefrom; and

a blocking mechanism, actuation of which changes the shape of the needle housing and prevents reuse of the needle with the lancing aid after the needle housing is removed from the lancing aid housing.

22. The lancing aid of claim 21, wherein the blocking mechanism is actuated upon insertion of the needle housing into the lancing aid housing, the needle being movable to the lancing position to perform a lancing operation after the actuation of the blocking mechanism.

23. The lancing aid of claim 21, wherein the needle housing comprises a hole through which the needle tip emerges in the lancing position, the hole configured for alignment with a lancing opening in the lancing aid housing when the needle housing is inserted into the lancing aid housing.

24. The lancing aid of claim 21, wherein the needle housing comprises a magazine and the needle comprises a plurality of needles.

25. The lancing aid of claim 21, wherein the needle housing comprises a holding element configured to interact with the lancing aid housing upon insertion of the needle housing into the lancing aid housing, the actuation of the blocking mechanism preventing the interaction of the holding element with the lancing aid housing after the needle housing is removed from the lancing aid housing.

26. The lancing aid of claim 21, wherein the blocking mechanism comprises a ring surrounding and movable relative to the needle housing.

27. The lancing aid of claim 26, wherein actuation of the blocking mechanism causes the ring to move to a position which allows at least one area of the needle housing to enlarge.

28. The lancing aid of claim 27, wherein the enlargement takes place as or after the needle housing is removed from the lancing aid housing.

29. The lancing aid of claim 21, wherein the actuation of the blocking mechanism prevents the needle housing from being reinserted into the lancing aid housing after removal.

30. The lancing aid of claim 21, wherein the first and second resting positions are the same.

31. The lancing aid of claim 21, wherein the needle is configured to move between the second resting position and the lancing position multiple times after the needle housing is inserted in the lancing aid housing and before the needle housing is removed from the lancing aid housing, whereby the needle can be reused.

32. The lancing aid of claim 21, wherein the needle is configured to move between the second resting position and the lancing position multiple times after the actuation of the blocking mechanism.

33. The lancing aid of claim 27, wherein the at least one portion of the needle housing that is enlarged comprises a flexible arm that moves outwardly when the blocking mechanism is actuated.

39. The lancing aid of claim 21, wherein the blocking mechanism is movably connected to the needle housing between a first position in which the needle can be used with the lancing aid and a second position in which, after removal of the lancet system from the lancing aid, use of the lancet system with the lancing aid is prevented.

34. A lancet system for insertion into a lancing aid, the lancet system comprising:

at least one needle with a tip for producing a skin opening;

a needle housing with a holding element that interacts with a holding element of the lancing aid when the lancet system is inserted into the lancing aid, wherein the needle housing is movably connected with the needle in such a manner that at least one protective portion of the needle housing and the needle can be moved relative to one another;

wherein the protective portion of the needle housing at least partially surrounds the needle tip in a first position and in a second position, the protective portion of the needle housing and the needle tip are spatially separated from one another such that the needle is released by the protective portion of the needle housing, the protective portion of the needle housing being positioned in the first position when the lancet system is removed from the lancing aid; and

a blocking mechanism in the needle housing, wherein the blocking mechanism is actuated by an interaction with the lancing aid and changes the needle housing such that, after removal of the lancet system from the lancing aid, the holding element is prevented from interacting with the holding element of the lancing aid, wherein reuse of the lancet system with the lancing aid after the lancet system is removed from the lancing aid is prevented and the actuation of the blocking mechanism enlarges at least one area of the needle housing.

42. The lancet system of claim 34, wherein the needle housing comprises a magazine housing that contains a plurality of needles.

43. The lancet system of claim 34, wherein the blocking mechanism is actuated independently of the protective portion of the needle housing and the needle moving relative to one another.

35. A lancet system, comprising:

a needle housing configured for insertion into a lancing aid and removal therefrom after use;

a needle movably mounted to the needle housing, the needle having a tip for producing a skin opening;

the needle being movable from a first resting position in which the needle housing at least partially surrounds the tip, to a lancing position in which the tip is exposed for puncturing a body part, and to a second resting position in which the needle housing at least partially surrounds the tip, the needle occupying the second resting position when the needle housing is removed from the lancing aid;

a blocking mechanism, actuation of which changes the shape of the needle housing and prevents reuse of the needle with the lancing aid after the needle housing is removed from the lancing aid; and

wherein, the blocking mechanism comprises a movable ring surrounding the needle housing and actuation of the blocking mechanism causes the ring to move to a position which allows at least one area of the needle housing to enlarge.

36. The lancet system of claim 35, wherein the enlargement takes place as or after the needle housing is removed from the lancing aid.

37. The lancet system of claim 35, wherein the at least one portion of the needle housing that is enlarged comprises a flexible arm that moves outwardly when the blocking mechanism is actuated.

44. The lancet system of claim 35, wherein the needle is movable to and from the lancing position multiple times after the needle housing is inserted into the lancing aid and before removal therefrom.

45. The lancet system of claim 35, wherein the blocking mechanism is actuated upon insertion of the needle housing into the lancing aid.

46. The lancet system of claim 35, wherein the needle housing comprises a magazine and the needle comprises a plurality of needles.

38. A lancet system, comprising:

a needle housing configured for insertion into a lancing aid and removal therefrom after use;

a needle movably mounted to the needle housing, the needle having a tip for producing a skin opening;

the needle being movable from a first resting position in which the needle housing at least partially surrounds the tip, to a lancing position in which the tip is exposed for puncturing a body part, and to a second resting position in which the needle housing at least partially surrounds the tip, the needle occupying the second resting position when the needle housing is removed from the lancing aid; and

a blocking mechanism, actuation of which allows at least one area of the needle housing to enlarge, which prevents reuse of the lancet system with the lancing aid after the needle housing is removed from the lancing aid.

47. The lancet system of claim 38, wherein the enlargement takes place as or after the needle housing is removed from the lancing aid.

48. The lancet system of claim 38, wherein the at least one portion of the needle housing that is enlarged comprises a flexible arm that moves outwardly.

49. The lancet system of claim 38, wherein the blocking mechanism comprises a ring surrounding and movable relative to the needle housing.

50. The lancet system of claim 49, wherein actuation of the blocking mechanism causes the ring to move to a position which allows the at least one area of the needle housing to enlarge.

51. The lancet system of claim 38, wherein the actuation of the blocking mechanism prevents the needle housing from being reinserted into the lancing aid housing after removal.

52. The lancet system of claim 38, wherein the first and second resting positions are the same.

53. The lancet system of claim 38, wherein the needle is configured to move between the second resting position and the lancing position multiple times after the needle housing is inserted in the lancing aid housing and before the needle housing is removed from the lancing aid housing, whereby the needle can be reused.