Lancet integrated test element tape dispenser

• US 8,621,828 B2
• Filed: 05/11/2012
• Issued: 01/07/2014
• 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: Chan, Frank A., Wong, Daniel
• Primary Examiner(s): Bass, Dirk
• Assistant Examiner(s): Wecker, Jennifer
• Application Number:
  US13/469,692
• Publication Number:
  US 20120226195A1
• Time in Patent Office: 606 Days
• Field of Search: 422/22, 422/40, 422/66, 422/410, 422/430, 600/573, 600/576, 600/578, 600/583, 606/181, 606/182, 436/8, 436/44, 436/165
• US Class Current: 53/426
• 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. A method, comprising:

forming directly on a sterility sheet one or more electrodes for one or more test elements configured to analyze body fluid; and

folding the sterility sheet around one or more piercing members configured to pierce tissue, wherein each piercing member is associated with one of the test elements and the folded sterility sheet sandwiches the one or more piercing members therein.

2. The method of claim 1, further comprising:

sterilizing the piercing members.

3. The method of claim 2, wherein said sterilizing and said folding occur before said forming.

4. The method of claim 3, further comprising:

applying a reagent on or near the one or more electrodes after said sterilizing.

5. The method of claim 2, further comprising:

wherein said forming occurs before said sterilizing; and

applying a reagent on or near the one or more electrodes after said sterilizing.

6. The method of claim 5, wherein said folding occurs before said sterilizing.

7. The method of claim 5, further comprising:

attaching one or more spacers to the sterility sheet before said sterilizing; and

attaching one or more vent members to the sterility sheet before said sterilizing.

8. The method of claim 1, further comprising:

sealing the sterility sheet around the piercing members.

9. The method of claim 1, further comprising:

wherein the sterility sheet forms a tape; and

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

10. The method of claim 9, wherein said forming on the sterility sheet the plurality of guide members comprises punching notches in the tape to define the guide members.

11. The method of claim 9, further comprising:

wherein each piercing member is associated with one of the test elements to form an integrated sampling element; and

wherein said forming on the sterility sheet the plurality of guide members comprises locating the guide members on every other integrated sampling element.

12. The method of claim 9, wherein the plurality of guide members extend from at least one edge of the tape.

13. The method of claim 1, further comprising:

forming tractor holes in the sterility sheet.

14. The method of claim 1, further comprising:

wherein the sterility sheet forms a tape;

wherein the folding the sterility sheet includes folding the tape to create a folded tape section; and

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

15. The method of claim 14, wherein said folding the tape includes folding the tape in a fanfold manner where adjacent sections of the tape contact one another.

16. A method, comprising:

forming a plurality of electrodes directly on a sterility sheet;

applying a reagent on the plurality of electrodes configured to analyze body fluid; and

folding the sterility sheet about a plurality of piercing members configured to pierce tissue, wherein each piercing member is sandwiched between a top layer and a bottom layer of the sterility sheet.

17. The method of claim 16, further comprising:

sealing the sterility sheet around the piercing members.

18. The method of claim 16, further comprising:

attaching a plurality of spacers to the sterility sheet; and

attaching a plurality of vent members to the sterility sheet.

19. A method, comprising:

forming directly on one sterility sheet one or more electrodes for one or more test elements configured to analyze body fluid;

folding the sterility sheet to form two flaps with a fold line between the two flaps; and

sandwiching one or more piercing members configured to pierce tissue between the two flaps of the sterility sheet, wherein one piercing member is associated with one test element.

20. The method of claim 19, further comprising:

sterilizing the one or more piercing members.