Lancet integrated test element tape dispenser

• US 20070173740A1
• Filed: 01/05/2006
• Published: 07/26/2007
• Est. Priority Date: 01/05/2006
• Status: Active Grant

• Current Assignee: Roche Diabetes Care Inc. (Roche Holding AG)
• Original Assignee: Roche Diagnostics Operations Incorporated (Roche Holding AG)
• Inventors: Wong, Daniel, Chan, Frank
• Granted Patent: US 7,481,777 B2
• Time in Patent Office: Days
• US Class Current: 600/583
• CPC Class Codes: A61B 5/1486 using enzyme electrodes, e.g. with immobilised oxidase
• CPC Class Codes: A61B 5/150022 for capillary blood or interstitial fluid
• CPC Class Codes: A61B 5/150213 Venting means
• CPC Class Codes: A61B 5/150282 for piercing elements, e.g. blade, lancet, canula, needle
• CPC Class Codes: A61B 5/150335 by radiation
• 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 5/150435 Specific design of proximal end
• 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 5/150633 Protective sleeves which are axially extensible, e.g. sleeves connected to, or integrated in, the piercing or driving device; pivotable protective sleeves
• 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 5/150786 Optical identification systems, e.g. bar codes, colour codes
• CPC Class Codes: A61B 5/150793 Electrical or magnetic identification means
• CPC Class Codes: A61B 5/15087 short range, e.g. between console and disposable using implanted devices A61B5/150877
• 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 5/15123 comprising magnets or solenoids
• 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 5/15167 Characterized by a folded 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
• 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 5/157 : Devices characterised by integrated means for measuring characteristics of blood
• CPC Class Codes: A61B 5/6848 : Needles
• CPC Class Codes: G01N 33/48764 : Test tape taken off a spool
• CPC Class Codes: Y10T 29/49124 : On flat or curved insulated base, e.g., printed circuit, etc.
• CPC Class Codes: Y10T 29/49826 : Assembling or joining
• CPC Class Codes: Y10T 436/10 : Composition for standardization, calibration, simulation, stabilization, preparation or preservation; processes of use in preparation for chemical testing
• CPC Class Codes: Y10T 436/110833 : Utilizing a moving indicator strip or tape

Abstract

A lancet integrated test element tape includes a plurality of lancet integrated test elements. The lancet integrated test elements each include a lancet configured to form an incision in tissue and a test element configured to analyze body fluid from the incision in the tissue. A cartridge includes a supply compartment configured to store an unused section of the tape. The tape is folded within the supply compartment to limit damage to the lancet integrated test elements. The cartridge can further include a waste compartment in which a used section of the tape is stored. An indexing mechanism moves the tape between the supply and waste compartments.

Claims

1. An apparatus, comprising:

a lancet integrated test tape comprising a plurality of lancet integrated test units, the lancet integrated test units each comprising

a lancet configured to form an incision in tissue, and

a test element configured to analyze body fluid from the incision in the tissue; and

a cartridge comprising a supply compartment configured to store an unused section of the lancet integrated test tape, the lancet integrated test tape being folded within the supply compartment to limit damage to the lancet integrated test units.

2. The apparatus of claim 1, wherein the cartridge comprises a waste compartment in which a used section of the lancet integrated test tape is stored.

3. The apparatus of claim 2, wherein the waste compartment comprises a reel around which the used section of the lancet integrated test tape is wrapped.

4. The apparatus of claim 2, wherein the used section of the lancet integrated test tape is stored in a folded manner within the waste compartment.

5. The apparatus of claim 1, further comprising a feed mechanism configured to feed the lancet integrated test tape from the supply compartment.

6. The apparatus of claim 1, wherein the feed mechanism includes a reel configured to rotate to wrap the lancet integrated test tape around the reel.

7. The apparatus of claim 1, wherein:

the lancet integrated test tape has tractor openings; and

the feed mechanism includes a tractor mechanism that engages the tractor openings in the lancet integrated test tape.

8. The apparatus of claim 1, further comprising a meter coupled to the cartridge for providing analysis results from the test elements.

9. The apparatus of claim 1, wherein the unused section of the lancet integrated test tape is folded in a fanfold manner within the supply compartment.

10. The apparatus of claim 1, wherein the unused section of the lancet integrated test tape is folded in an accordion manner within the supply compartment.

11. The apparatus of claim 10, further comprising:

a feed mechanism to feed the lancet integrated test tape;

wherein the lancet integrated test tape includes fold lines between each lancet integrated test unit;

wherein the lancets and test elements are joined together at alternating fold lines for folding the lancet integrated test tape in the accordion manner in which the lancets and test elements are folded away from each other within the supply compartment; and

wherein the lancet integrated test tape is configured to unfold during indexing in a manner in which the lancets and test elements are sandwiched together to form the lancet integrated test units.

12. The apparatus of claim 1, wherein:

the lancets are incorporated into a lancet tape; and

the test elements are incorporated into a test element tape.

13. The apparatus of claim 12, wherein the lancet tape and the test element tape are folded and stored separately within the cartridge.

14. The apparatus of claim 1, wherein:

the cartridge includes a guide channel; and

the lancet integrated test tape includes one or more alignment members received in the guide channel to guide the lancet integrated test tape within the cartridge.

15. The apparatus of claim 14, wherein the alignment members are defined by notches formed in the lancet integrated test tape.

16. The apparatus of claim 1, wherein:

the lancet integrated test tape comprises cover sections between the lancet integrated test units that protect lancets and test elements prior to use; and

the cover sections are configured to peel away to expose the lancets and the test elements.

17. An apparatus, comprising:

a tape comprising a plurality of test elements configured to analyze body fluid; and

a cartridge comprising

a supply compartment configured to store an unused section of the tape, the unused section of the tape being folded within the supply compartment, and

a waste compartment configured to store a used section of the tape; and

an indexing mechanism configured to index the tape between the supply compartment and the waste compartment.

18. The apparatus of claim 17, wherein the tape comprises a plurality of piercing members configured to pierce tissue.

19. An apparatus, comprising:

a tape comprising a plurality of test elements configured to analyze body fluid; and

a cartridge comprising

a supply compartment configured to store an unused section of the tape, the unused section of the tape being folded within the supply compartment, and

a waste compartment configured to store a used section of the tape, the used section of the tape being folded within the waste compartment.

20. A method, comprising:

assembling on a sterility sheet a plurality of test elements configured to analyze body fluid; and

enclosing in the sterility sheet a plurality of piercing members configured to pierce tissue, wherein each piercing member is associated with one of the test elements to create a tape of integrated sampling elements.

21. The method of claim 20, further comprising:

sterilizing the piercing members.

22. The method of claim 21, wherein:

said enclosing occurs prior to said assembling on the sterility sheet the plurality of test elements; and

said sterilizing occurs prior to said assembling on the sterility sheet the plurality of test elements.

23. The method of claim 21, wherein:

said enclosing occurs after said assembling on the sterility sheet the plurality of test elements; and

said sterilizing occurs after said assembling on the sterility sheet the plurality of test elements.

24. The method of claim 21, wherein:

said assembling comprises assembling one or more components of the test elements that are unaffected by said sterilization on the sterility sheet prior to said sterilization; and

said assembling comprises assembling one or more components of the test elements that are affected by said sterilization on the sterility sheet after said sterilization.

25. The method of claim 21, wherein:

the test elements comprise electrochemical sensors;

said assembling the components of the test elements that are unaffected by said sterilization comprises forming electrodes of the electrochemical sensors on the sterility sheet prior to said sterilization; and

said assembling the components of the test elements that are affected by said sterilization comprises applying a reagent for the electrochemical sensors after said sterilization.

26. The method of claim 20, wherein said enclosing comprises:

folding the sterility sheet around the piercing members; and

sealing the sterility sheet around the piercing members.

27. The method of claim 20, further comprising:

folding the tape after said enclosing to create a folded tape section; and

packing the folded tape section into a supply compartment of a cartridge.

28. The method of claim 27, further comprising:

forming on the sterility sheet a plurality of guide members configured to guide the tape in the cartridge.

29. The method of claim 28, wherein said forming on the sterility sheet the plurality of guide members comprises punching notches in the tape to define the guide members.