Method of preventing reuse in an analyte measuring system

• US 20050284773A1
• Filed: 06/29/2004
• Published: 12/29/2005
• Est. Priority Date: 06/29/2004
• Status: Abandoned Application

• Current Assignee: Lifescan Incorporated (Duv Holding Corporation)
• Original Assignee: Lifescan Incorporated (Duv Holding Corporation)
• Inventors: Allen, John J.
• Application Number:
  US10/881,774
• Publication Number:
  US 20050284773A1
• Time in Patent Office: Days
• US Class Current: 205/777.5
• CPC Class Codes: A61B 2560/0276 Determining malfunction
• CPC Class Codes: A61B 2562/0295 Strip shaped analyte sensors for apparatus classified in A61B5/145 or A61B5/157 disposable multilayered or laminated electrodes G01N27/307; details of handling chemical test elements G01N33/4875
• CPC Class Codes: A61B 5/150022 for capillary blood or interstitial fluid
• CPC Class Codes: A61B 5/150213 Venting means
• CPC Class Codes: A61B 5/150358 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 5/150442 Blade-like piercing elements, e.g. blades, cutters, knives, for cutting the skin
• CPC Class Codes: A61B 5/150923 by means for destroying components or parts, e.g. by cutting or piercing
• CPC Class Codes: A61B 5/15186 Devices loaded with a single lancet, i.e. a single lancet with or without a casing is loaded into a reusable drive device and then discarded after use; drive devices reloadable for multiple use
• CPC Class Codes: B01L 2200/141 Preventing contamination, tampering
• CPC Class Codes: B01L 2300/0645 Electrodes
• CPC Class Codes: B01L 2300/0825 Test strips
• CPC Class Codes: B01L 2400/0406 capillary forces
• CPC Class Codes: B01L 3/5027 by integrated microfluidic structures, i.e. dimensions of channels and chambers are such that surface tension forces are important, e.g. lab-on-a-chip B01L3/5023 takes precedence; micromixers B01F33/30; microreactors for synthesis B01J19/0093; microcapillary devices in general B81B1/00
• CPC Class Codes: B01L 3/502707 characterised by the manufacture of the container or its components by shaping or joining plastic parts B29C59/00, B29C65/00; by laminating B32B37/00; manufacture of microstructural devices in general B81C
• CPC Class Codes: B01L 3/502715 characterised by interfacing components, e.g. fluidic, electrical, optical or mechanical interfaces
• CPC Class Codes: G01N 33/48771 Coding of information, e.g. calibration data, lot number

Abstract

The present invention is a method of preventing reuse of test strips for measuring an analyte or indicator such as glucose in a physiological fluid such as blood, interstitial fluid, or urine. The present invention also relates to a method of preventing reuse of test strips incorporating an integrated lance such as a needle, blade, or other sharp or skin puncturing device. Certain types of medical devices such as, for example, glucose test strips were intended to be tested only once and then disposed. This requirement is often needed because the reagent chemistry in many test strips is not suitable for measuring glucose a second time. However, it is possible that some user will accidentally test a previously used test strip. This could potentially become a problem if the glucose meter attempts to make a glucose measurement and outputs a result. Therefore, it is desirable that a single use test strip and meter have a prescribed method for preventing a previously tested test strip from being reused.

Claims

1. A method of preventing the reuse of a test strip in an analyte measuring system, said method comprising the steps of:

inserting a test strip into a meter

detecting electrical continuity between a first electrical contact zone and a second electrical contact zone on said test strip and initiating a measurement sequence when said electrical continuity is present;

applying a physiological sample to said disposable test trip;

measuring a signal from said test strip that corresponds to an analyte concentration; and

applying a voltage between said first electrical contact zone and said second electrical contact zone wherein said voltage is sufficient to destroy a frangible link between said first electrical contact and said second electrical contact.

2. A method according to claim 1 wherein said frangible link is a fuse zone positioned between said first and second electrical contact zones.

3. A method according to claim 2, wherein said fuse zone has a higher resistance than said first and second electrical contact zones.

4. A method according to claim 1, wherein said frangible link is a material chosen from a group consisting of carbon, silver, platinum, palladium, gold, Ir, Pt, tungsten, copper, and aluminum.

5. A method according to claim 2, wherein said fuse zone has a positive temperature coefficient of resistance.

6. An analyte measuring system of claim 5, wherein said fuse zone melts when said predetermined voltage is applied between said first electrical contact and said second electrical contact.

7. A method according to claim 6, wherein said predetermined voltages ranges from about 1.5 volts to about 30 volts.

8. A method according to claim 1, wherein said test strip further comprises an integrated lance.

9. A method according to claim 1, wherein said analyte is glucose

10. A method according to claim 1, wherein said test strip further comprises a working electrode and a reference electrode

11. A method according to claim 10, wherein a reagent layer is disposed on at least a portion of said working electrode.

12. A method according to claim 11, wherein said reagent layer comprises a redox mediator and a redox enzyme.

13. A method according to claim 11, wherein said reagent layer comprises a silica filler.

14. A method of preventing the reuse of a test strip, said method comprising the steps of:

providing a test strip comprising;

a plurality of electrical contacts;

a sample chamber adapted to receive a sample of bodily fluid, wherein said sample chamber is connected to a fist pair of said electrical contacts;

a frangible link connected to a second pair of said electrical contacts;

applying a predetermined voltage across said second pair of electrodes which said predetermined voltage is sufficient to destroy said frangible link.

15. A method according to claim 14, wherein said frangible link is a fuse.

16. A method according to claim 15, wherein said predetermined voltage is in the range of between approximately 1.5 and approximately 30 volts.