Lancets for bodily fluid sampling supplied on a tape

• US 20050245845A1
• Filed: 04/14/2005
• Published: 11/03/2005
• Est. Priority Date: 04/30/2004
• Status: Active Grant

• Current Assignee: Roche Diabetes Care Inc. (Roche Holding AG)
• Original Assignee: Roche Diagnostics Operations Incorporated (Roche Holding AG)
• Inventors: Roe, Steven N., List, Hans, Raney, Charles C.
• Granted Patent: US 7,909,776 B2
• Time in Patent Office: Days
• US Class Current: 600/583
• 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 5/150213 Venting means
• 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 5/150282 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 5/150419 comprising means for capillary action
• 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 5/15113 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 5/15146 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 5/15153 Multiple piercing elements stocked in a single compartment
• CPC Class Codes: A61B 5/15169 Characterized by a rolled strip
• CPC Class Codes: A61B 5/15173 Characterized by propelling the piercing element parallel to the direction of movement of the strip
• CPC Class Codes: A61B 5/15184 Piercing device comprising a separate compartment or unit for used piercing elements separate compartments for used piercing elements in stocking means A61B5/15178
• CPC Class Codes: A61B 5/157 Devices characterised by integrated means for measuring characteristics of blood
• CPC Class Codes: Y10T 436/110833 Utilizing a moving indicator strip or tape

Abstract

A supply of lancets for a multi-use lancing device are carried by a tape and sequentially brought from a storage position to an activating position by advancing the tape around a bend. The lancets are non-circular in cross-section along their longitudinal lengths, and in their activating position they extend from the tape such that their sharp tips are available for lancing tissue. The carrying tape can be arranged in reel-to-reel format in a housing having a lancing opening. The lancets can be integral with the tape and activated to move the lancet through the lancing opening by moving the tape along its tape path or by translating a dedicated service loop of the tape. The lancets can also be independent from the tape and activated through the lancing opening by a separate lancing actuator. A test media can be included on the carrying tape and the housing can contain a sensor to yield an integrated lancing and testing device.

Claims

1. A multi-use lancing device for sampling a bodily fluid comprising:

a carrying tape having a length and defining a supply section, a storage section, and an activating section between the supply and storage sections, wherein there is at least one bend in the activating section of the carrying tape;

a plurality of lancets carried along the length of the tape, each of the lancets having a proximal portion, a distal portion, and a lancet length, wherein a substantial portion of the lancet length is non-circular in cross section, and wherein the distal portion includes a sharp tip that is uncontaminated with the bodily fluid when in the supply section of the carrying tape; and

a removable cover over the lancets that are in the supply section of the carrying tape;

wherein the lancets are oriented on the carrying tape such that their proximal portions precede their sharp tips as the lancets are carried from the supply section to the activating section by advancement of the tape.

2. The device of claim 1 wherein a lancet adjacent the bend in the activating section of the carrying tape is in an activating position relative to the carrying tape, the activating position having the sharp tip extending away from an adjacent surface of the carrying tape for lancing tissue to obtain the bodily fluid sample.

3. The device of claim 1 wherein the lancets are composed of a hardened stainless steel or shape memory alloy.

4. The device of claim 3 wherein the lancets are composed of a nickel titanium alloy.

5. The device of claim 1 the supply section of the carrying tape is wrapped around a supply reel and the storage section of the carrying tape is wrapped around a storage reel.

6. The device of claim 5 wherein the bend in the carrying tape is a portion of a service loop of the carrying tape, and wherein the service loop is translatable relative to at least one of the supply and the storage reel.

7. The device of claim 1 wherein the proximal portions of the lancets are integral with the carrying tape.

8. The device of claim 1 wherein the removable cover is a substantially continuous strip and the device further comprises a take up reel for peeling the removable cover from the carrying tape.

9. The device of claim 8 wherein the removable cover is replaced over the lancets in the storage section of the tape.

10. A multi-use lancing device comprising:

a housing having a lancet opening and containing a supply reel and a storage reel;

an elongated flexible carrying tape configured for reel-to-reel transfer from the supply reel to the storage reel;

a plurality of lancets sequentially positioned along the carrying tape and each having a lancet length and a distal portion defining a sharp tip;

a sterile removable cover over the lancets in the supply reel; and

a take-up reel for removing the cover from the lancets as the lancets are advanced from the supply reel to the storage reel.

11. The device of claim 10 wherein a substantial portion of the lancet length is high-aspect ratio in cross section.

12. The device of claim 10 wherein the lancets are composed of a hardened stainless steel or a shape memory alloy.

13. The device of claim 10 further comprising a cover application reel for placing a cover over the lancets being advanced onto the storage reel.

14. The device of claim 13 wherein the cover removed from the lancets by the take-up reel is placed over the lancets by the cover application reel.

15. The device of claim 10 further comprising a plurality of test media carried on the tape, at least one test media associated with each of the plurality of lancets.

16. The device of claim 10 wherein the lancets include a capillary groove for conveying a bodily fluid sample to an associated test media.

17. A supply of lancets in reel-to-reel fashion comprising:

a supply reel, a storage reel and a carrying tape configured for reel-to-reel transfer from the supply reel to the storage reel;

a first lancet wrapped around the supply reel and flexed into a non-linear orientation;

a second lancet on the carrying tape between the supply and storage reels and in a generally linear orientation; and

a removable cover over at least the first lancets and not over the second lancet.

18. The supply of lancets of claim 17 wherein there are a plurality of first lancets wrapped around the supply reel and flexed into a non-linear orientation.

19. The supply of lancets of claim 18 wherein the lancets are constructed of a hardened stainless steel or shape memory alloy.

20. The supply of lancets of claim 17 wherein the removable cover is in the form of a substantially continuous strip.

21. The supply of lancets of claim 20 wherein the substantially continuous strip has a first portion wrapped around the supply reel and a second portion wrapped around the storage reel.

22. The supply of lancets of claim 17 wherein a substantial portion of the second lancet is substantially planar.

23. The supply of lancets of claim 17 wherein the first and second lancets are integral with the carrying tape.

24. A multi-use device for sampling a bodily fluid comprising:

a housing defining a lancing opening and containing a carrying tape configured to sequentially carry a plurality of lancets from a supply reel containing lancets uncontaminated with the bodily fluid to an activating section of the carrying tape adjacent the lancing opening; and

a removable cover over the lancets on the supply reel;

wherein the lancets each include a distal portion with a sharp tip

wherein a substantial portion of the length of each lancet is non-circular in cross section; and

wherein the lancets are positioned on the carrying tape to have a proximal portion thereof lead the distal portion from the supply reel into the activating section.

25. The multi-use sampling device of claim 24 wherein the lancets are slideably positioned on the tape member.

26. The multi-use device of claim 24 wherein the lancets are integral with the tape.

27. The multi-use device of claim 24 wherein the carrying tape includes at least one test media associated with each of the lancets for detecting at least one property of the bodily fluid obtained by the lancet.

28. The multi-use device of claim 27 wherein the removable cover is over test media in the supply reel to protect the test media from moisture contamination prior to use.

29. A method for obtaining a bodily fluid sample comprising:

providing a reel-to-reel tape carrying a plurality of lancets that are non-circular in cross section along a major portion of their lengths;

removing a sterile cover from a first lancet;

advancing the tape to position the first lancet adjacent a bend in the tape with a sharp tip of the first lancet spaced from the tape;

piercing tissue with the sharp tip of the first lancet; and

after the piercing, advancing the tape to bring the sharp tip of the first lancet closer to the tape.

30. The method of claim 29 further comprising:

after the piercing, positioning a second lancet adjacent the bend in the tape with the sharp tip of the second lancet spaced from the tape; and

piercing tissue with the sharp tip of the second lancet.

31. The method of claim 29 further comprising contacting a bodily fluid produced from the piercing with a test media carried by the tape.

32. The method of claim 31 wherein the bodily fluid translates along a capillary groove in the lancet to contact the test media.

33. The method of claim 29 wherein the lancets are carried on the tape with their sharp tips pointing away from the direction of tape advancement.

34. A method for obtaining a bodily fluid sample comprising:

removing a sterile cover from a first lancet carried by a tape;

positioning the first lancet adjacent a bend in a service loop portion of the tape;

relatively translating the service loop portion of the tape to lance tissue with the first lancet.

35. The method of claim 34 wherein the relatively translating includes pivoting a pivoting member.

36. The method of claim 34 further comprising:

after the relatively translating, advancing the tape to positioning a second lancet adjacent the bend in the service loop; and

lancing tissue with the second lancet.

37. A device for lancing tissue comprising:

a supply of sterile lancets carried by a tape along a tape path defining at least one bend, wherein at least a tip of one of the supply of lancets is under a sterile cover;

wherein the lancets have a length and a non-circular cross section along their lengths such that each lancet has substantially different degrees of flexibility in different directions relative to their length;

wherein a lancet adjacent the bend extends generally linearly from the tape for lancing tissue;

wherein a lancet not adjacent the bend is flexed into a non-linear orientation for compact storage.

38. The device of claim 37 further comprising a supply of test media carried by the tape.

39. The device of claim 37 wherein the sterile cover is adapted to be pierced by a lancet prior to lancing.

40. The device of claim 37 wherein the sterile cover is adapted to be peeled from the tape to expose a lancet for use.

41. The device of claim 37 wherein the lancets are substantially planar along a major portion of their length.

42. The device of claim 37 wherein the at least one bend is a portion of a service loop of the tape that is separately translatable relative to the remainder of the tape.

43. A method comprising:

providing a multi-use lancing device having a supply of lancets on a tape, wherein at least a tip of at least one of the supply of lancets is under a sterile cover;

bringing a first lancet from a flexed orientation to a generally linear orientation;

lancing tissue with the first lancet in the generally linear orientation; and

bringing a second lancet from a flexed orientation to generally linear orientation for a subsequent lancing.

44. The method of claim 43 wherein the lancets in the flexed orientation are wrapped around a supply reel.