Lancet integrated test element tape dispenser

• US 8,196,374 B2
• Filed: 11/23/2011
• Issued: 06/12/2012
• 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): Bullock, In Suk
• Assistant Examiner(s): Wecker, Jennifer
• Application Number:
  US13/304,147
• Publication Number:
  US 20120067006A1
• Time in Patent Office: 202 Days
• Field of Search: None
• 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:

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

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;

sterilizing the piercing members; and

said assembling on the sterility sheet the plurality of test elements comprising assembling one or more components of the test elements that are unaffected by said sterilization on the sterility sheet prior to said sterilization, and assembling one or more components of the test elements that are affected by said sterilization on the sterility sheet after said sterilization;

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; and

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

2. The method of claim 1, wherein:

the test elements comprise electrochemical sensors.

3. The method of claim 1, wherein said enclosing comprises:

folding the sterility sheet around the piercing members; and

sealing the sterility sheet around the piercing members.

4. The method of claim 1, wherein said forming on the sterility sheet the plurality of guide members comprises punching notches in the tape to define the guide members.

5. The method of claim 1, wherein said forming on the sterility sheet the plurality of guide members comprises locating the guide members on every other integrated sampling element.

6. The method of claim 1, wherein the plurality of guide members extend from at least one edge of the tape.

7. The method of claim 1, further comprising:

forming tractor holes in the sterility sheet.

8. A method, comprising:

joining a tape of lancets and a tape of test elements at least at alternating fold lines; and

folding the tape of the lancets and the tape of the test elements in an accordion manner in which the lancets and the test elements are folded away from one another.

9. The method of claim 8, further comprising:

packing the tape of the lancets and the tape of the test elements in a cartridge in a stacked manner.

10. The method of claim 8, further comprising:

folding a sterility sheet around the lancets; and

sealing the sterility sheet around the lancets.

11. The method of claim 10, further comprising:

sterilizing the tape of the lancets separately from the tape of the test elements.

12. The method of claim 8, further comprising:

manufacturing the tape of the test elements to be wider than the tape of the lancets.

13. The method of claim 8, further comprising:

positioning the lancets on the tape to have blank sections in between folds; and

positioning the test elements on the tape to have blank sections in between folds.