Electrochemical sensors with carrier field

• US 8,956,518 B2
• Filed: 04/20/2011
• Issued: 02/17/2015
• Est. Priority Date: 04/20/2011
• Status: Active Grant

• Current Assignee: LifeScan IP Holdings, LLC
• Original Assignee: Lifescan Incorporated (Duv Holding Corporation)
• Inventors: Chambers, Garry, Hodges, Alastair M., Chatelier, Ronald C.
• Primary Examiner(s): Van, Luan
• Assistant Examiner(s): RUFO, LOUIS J
• Application Number:
  US13/090,620
• Publication Number:
  US 20120267245A1
• Time in Patent Office: 1,399 Days
• Field of Search: 204/403.02, 204/403.04
• US Class Current: 204/403.04
• CPC Class Codes: A61B 5/1486 using enzyme electrodes, e.g. with immobilised oxidase
• CPC Class Codes: G01N 27/327 Biochemical electrodes , e.g. electrical or mechanical details for in vitro measurements
• CPC Class Codes: G01N 27/3272 Test elements therefor, i.e. disposable laminated substrates with electrodes, reagent and channels optical biosensors G01N33/52
• CPC Class Codes: G01N 27/403 Cells and electrode assemblies
• CPC Class Codes: Y10T 29/49002 Electrical device making

Abstract

An electrochemical sensing apparatus and methods are provided. In one embodiment, an apparatus is provided having a carrier that supports an electrochemical module and that communicates between electrodes on the electrochemical module and an analyte measurement device.

Claims

1. A test strip configured for reception by a test meter, said test strip comprising:

a carrier defined by one or more nonconductive substrates and having first and second electrically conductive regions that are electrically isolated from one another, the carrier including a fold line transverse to a major dimension of the carrier along which top and bottom portions are defined, said portions carrying the first and second conductive regions, respectively, and an opening extending therethrough; and

an electrochemical module mounted to the carrier such that at least a portion of the electrochemical module extends across the opening and is thereby exposed, the electrochemical module having an electrochemical cavity with a first electrode in electrical communication with the first conductive region of the carrier, a second electrode in electrical communication with the second conductive region of the carrier, and a sample receiving chamber that includes a reagent layer and wherein the electrochemical module is mounted at opposing ends between the top and bottom portions within the opening.

2. The test strip of claim 1, wherein the opening extends across the fold line.

3. The test strip of claim 1, wherein the electrochemical module has a maximum length and a maximum width that is less than a maximum length and a maximum width of the carrier.

4. The test strip of claim 1, further comprising an adhesive disposed between the top and bottom portions of the carrier and configured to maintain the top and bottom portions at a fixed distance apart from one another.

5. The test strip of claim 1, wherein the sample receiving chamber of the electrochemical module is located between the opposed ends and is spaced apart from the carrier.

6. The test strip of claim 1, wherein the opening is located on a distal end of the carrier, and a proximal end of the carrier includes first and second contacts configured to establish a connection between the first and second electrodes and the test meter.

7. The test strip of claim 1, wherein the electrochemical module includes:

a top insulating substrate carrying the first electrode;

a bottom insulating substrate carrying the second electrode; and

a spacer disposed between the first and second electrodes and maintaining the first and second electrodes in a spaced apart relationship with one another.

8. The test strip of claim 7, wherein the top and bottom insulating substrates are offset from one another such that a portion of the first electrode on the top insulating substrate is in contact with the second electrically conductive region on the carrier, and a portion of the second electrode on the bottom insulating substrate is in contact with the first electrically conductive region on the carrier.

9. The test strip of claim 1, wherein the electrochemical module has a central portion extending along a central axis and containing the electrochemical cavity, and opposed end portions having central axes that extend at an angle relative to the central axis of the central portion.

10. The test strip of claim 1, wherein the carrier is inert.

11. A test strip configured for reception by a test meter, said test strip comprising:

a carrier defined by one or more substrates made from a non-conducting material and having

a first conductive area defined on a top portion, and

a second conductive area defined on a bottom portion electrically isolated from the first conductive area, and an opening formed through the carrier and in which the top portion and the bottom portion of the carrier are defined by a fold line extending transverse to a major dimension of the carrier;

an electrochemical module mounted on the carrier such that at least a portion of the module extends across the opening in the carrier and is thereby exposed, the electrochemical module having

a first electrode in communication with the first conductive area of the carrier,

a second electrode in communication with the second conductive area of the carrier,

an electrochemical cavity for receiving a fluid sample, the electrochemical cavity being formed between the first and second electrodes, and

a reagent disposed within the electrochemical cavity on at least one of the first and second electrodes for reacting with an analyte of a fluid sample received in the electrochemical cavity in which the top portion carries the first conductive area and the bottom portion carries the second conductive area, and wherein the electrochemical module has opposed ends engaged between the top and bottom portions within the opening.

12. The test strip of claim 11, wherein the electrochemical module has a first insulating substrate carrying the first electrode, and a second insulating substrate carrying the second electrode, the first and second electrodes facing one another in a spaced apart relationship.

13. The test strip of claim 11, wherein the opening is located along a perimeter of the carrier.

14. The test strip of claim 11, wherein the carrier has a maximum length and maximum width that is greater than a maximum length and maximum width of the electrochemical module.

15. The test strip of claim 11, further comprising an adhesive disposed between the top and bottom portions of the carrier and configured to maintain the top and bottom portions at a fixed distance apart from one another.

16. The test strip of claim 11, wherein the first and second conductive regions on the carrier are electrically isolated from one another along the fold line.

17. The test strip of claim 11, wherein the opening is located along the fold line.

18. The test strip of claim 11, wherein the electrochemical module is located on a distal end of the carrier, and a proximal end of the carrier includes first and second contacts configured to establish a connection between the first and second electrodes and an analyte measurement device.

19. The test strip of claim 11, wherein the electrochemical module has a mid-portion located between the opposed ends and spaced a distance apart from the carrier.

20. The test strip of claim 11, wherein the electrochemical module has a central portion extending along a central axis and containing the electrochemical cavity, the opposed end portions having central axes that extend at an angle relative to the central axis of the central portion.

21. The test strip of claim 11, wherein the carrier is electrochemically non-functional.

22. A test strip configured for insertion within a test meter, said test strip comprising:

an electrochemical module having an electrochemical cavity with first and second electrodes, and a sample receiving chamber having a reagent layer configured to react with an analyte of a fluid sample received in the electrochemical cavity; and

a carrier having

a top insulating substrate having a first conductive region,

a bottom insulating substrate having a second conductive region,

a distal cut-out extending through a distal end of the top and bottom insulating substrates, at least a portion of the electrochemical module extending across the distal cut-out such that the first electrode is in electrical communication with the first conductive region and the second electrode is an electrical communication with the second conductive region, and

a proximal cut-out extending through a proximal end of the bottom insulating substrate of said carrier to expose a contact area on the first conductive region of the top insulating substrate such that the first contact area on the first conductive region of the top insulating substrate and a second contact area on the bottom insulating substrate are exposed to allow electrical connection with a test meter to establish a connection between the first and second electrodes and the test meter, the electrochemical module having opposed ends engaged between the top and bottom insulating substrates of the carrier at the distal cut-out, and wherein the electrochemical cavity is located between the opposed ends and extends outwardly away from the carrier.

23. A carrier web, comprising:

a carrier having first and second conductive areas electrically isolated from one another, and a plurality of openings spaced a distance apart from one another and disposed along a fold line; and

a plurality of electrochemical modules, each module being mounted across one of the plurality of openings and along the extending fold line, each electrochemical module having a first electrode in communication with the first conductive area, a second electrode isolated from the first electrode and in communication with the second conductive area, and an electrochemical cavity accessible through the opening in the carrier for receiving a fluid sample

wherein the fold line defines a top portion carrying the first conductive area and a bottom portion carrying the second conductive are;

and wherein the plurality of electrochemical modules are modules are mounted at opposing ends between the top and bottom portions within the openings.