Lancets for bodily fluid sampling supplied on a tape

• US 8,591,436 B2
• Filed: 04/30/2004
• Issued: 11/26/2013
• 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., Raney, Charles C.
• Primary Examiner(s): Hindenburg, Max
• Assistant Examiner(s): Pani, John
• Application Number:
  US10/836,578
• Publication Number:
  US 20050245954A1
• Time in Patent Office: 3,497 Days
• Field of Search: 600583-584, 606181-183, 436/44, 422/66
• US Class Current: 600/583
• CPC Class Codes: A61B 5/1411 by percutaneous method, e.g. by lancet
• 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 5/150358 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 5/15146 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 5/15151 Each piercing element being stocked in a separate isolated compartment
• 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 5/15167 Characterized by a folded strip
• 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 5/15173 Characterized by propelling the piercing element parallel to the direction of movement of the strip
• CPC Class Codes: A61B 5/15178 Stocking means comprising separate compartments or units for new and for used piercing elements separate compartments for used piercing elements in piercing devices A61B5/15184
• 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 housing defining a lancing slot;

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; and

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, wherein the proximal portion and the carrying tape form a unitary one-piece structure, 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;

wherein lancets in the supply section of the carrying tape are in a supply position relative to the carrying tape;

wherein a lancet adjacent the bend in the activating section of the carrying tape will travel through an activating phase relative to the carrying tape such that the distal portion having the sharp tip extends away from an adjacent surface of the carrying tape for lancing tissue to obtain the bodily fluid sample;

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;

wherein 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, the supply reel and the storage reel being spaced apart from each other, the supply reel and the storage reel being configured to rotate to advance the carrying tape; and

the carrying tape is contained in the housing, the sharp tip of the lancet extends through the lancing slot for lancing tissue and the sharp tip of the lancet retracts through the lancing slot after forming an incision in tissue when the lancet travels through the activating phase.

2. The device of claim 1 wherein the supply and storage reels are mounted in the housing to rotate about axes that are substantially parallel.

3. The device of claim 2 wherein the sharp tip of the lancet extends from the carrying tape in a direction substantially perpendicular to the axes of rotation of the supply and the storage reels when the lancet travels through the activating phase.

4. The device of claim 1 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.

5. The device of claim 4 further comprising an activating member configured to selectively translate the service loop to cause the lancet in the activating phase to rapidly advance and retract so as to lance tissue and obtain the bodily fluid sample.

6. The device of claim 5 wherein the service loop is adjacent a wheel rotatably mounted on a pivoting member with the axes of rotation of the wheel offset from a pivot axis of the pivoting member.

7. The device of claim 1 wherein lancets in a storage position are flexed and lancets that travel through the activating phase are generally linear.

8. The device of claim 1 wherein the carrying tape defines a centerline along its length and the lancets are slideably positioned in a slot of the carrying tape that is generally parallel to the centerline of the carrying tape.

9. The device of claim 8 further comprising a biased activator that, when engaged with a lancet in the activating phase, is operable to selectively advance and retract the lancet in the slot.

10. The device of claim 1 further comprising a plurality of test media carried on the carrying tape, wherein at least one test media is associated with each of the plurality of lancets.

11. The device of claim 10 wherein the test media are under a cover at least while in the supply section.

12. The device of claim 11 wherein at least a portion of the cover is adapted to be pierced by the sharp tip of a lancet when the lancet travels through the activating phase.

13. The device of claim 11 further comprising a sensor for analyzing the test media through the cover to determine at least one property of the bodily fluid.

14. The device of claim 1 further comprising a sterile cover for protecting the sharp tips of the lancets when the lancets are in a storage position.

15. The device of claim 1 wherein the activating phase includes a first position wherein the sharp tip is disposed towards the lancing slot as the carrying tape is advanced from the supply section to the storage section and a second position wherein the sharp tip extends through the lancing slot to form an incision in tissue as the carrying tape is reversed from the storage section to the supply section, the sharp tip in the first position being fully contained within the housing.

16. The device of claim 15 wherein the activating phase further comprises a third position wherein the sharp tip retracts through the lancing slot into the housing after forming an incision in tissue as the carrying tape is advanced from the supply section to the storage section.

17. The device of claim 16 further comprising:

means for moving the carrying tape to the first position, the sharp tip positioned past the lancing slot;

means for moving the carrying tape in an opposite direction to the second position; and

means for moving the carrying tape to the third position.

18. The device of claim 15 further comprising:

means for imparting a rapid back and forth movement to the carrying tape to move the sharp tip of a lancet from the first position to the second position and then to the first position to provide a lancing motion of a lancet in the activating phase.

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

a housing defining a lancing slot;

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, the proximal portion and the carrying tape form a unitary one-piece structure, and the distal portion includes a sharp tip;

wherein the supply section of the carrying tape is wrapped around a supply reel, the storage section of the carrying tape is wrapped around a storage reel, and the activating section contacts an activating reel adjacent the lancing slot, the supply reel and the storage reel are configured to move the carrying tape;

the plurality of 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 carrying tape; and

the carrying tape is contained in the housing, the sharp tip of the lancet extends through the lancing slot for lancing tissue and the sharp tip of the lancet retracts through the lancing slot after forming an incision in tissue when the lancet travels through an activating phase.

20. The device of claim 19 wherein the activating phase includes a first position in which the sharp tip is disposed towards the lancing slot and is fully contained within the housing as the carrying tape is advanced from the supply section to the storage section, and a second position wherein the sharp tip extends through the lancing slot upon reversing the carrying tape in a direction from the storage section to the supply section, the device further including:

means for imparting a rapid back and forth movement to the carrying tape to move the sharp tip of a lancet from the first position to the second position and then to the first position to provide a lancing motion of a lancet in the activating phase.