ELECTROCHEMICAL SENSORS WITH CARRIER

• US 20120267245A1
• Filed: 04/20/2011
• Published: 10/25/2012
• 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.
• Granted Patent: US 8,956,518 B2
• Time in Patent Office: Days
• US Class Current: 204/400
• 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. An electrochemical sensing apparatus, comprising:

a carrier having first and second electrically conductive regions that are electrically isolated from one another, the carrier including 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, 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.

2. The apparatus of claim 1, wherein the carrier is folded along a fold line to define a top portion and a bottom portion.

3. The apparatus of claim 2, wherein the opening extends across the fold line.

4. The apparatus 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.

5. The apparatus of claim 1, wherein the carrier has a top portion carrying the first conductive region and a bottom portion carrying the second conductive region, and wherein the electrochemical module is mounted between the top and bottom portions.

6. The apparatus of claim 5, 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.

7. The apparatus of claim 1, wherein the electrochemical module has opposed ends engaged between the top and bottom portions of the carrier, and wherein the sample receiving chamber is located between the opposed ends is spaced a distance apart from the carrier.

8. The apparatus 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 an analyte measurement device.

9. The apparatus 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.

10. The apparatus of claim 9, 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.

11. The apparatus 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.

12. The apparatus of claim 1, wherein the carrier is inert.

13. An electrochemical sensing apparatus, comprising:

a carrier having

a first conductive area,

a second conductive area electrically isolated from the first conductive area, and

an opening formed through the carrier; and

an electrochemical module mounted on the carrier such that at least a portion of the module is accessible through the opening in the carrier, 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.

14. The apparatus of claim 13, 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

15. The apparatus of claim 13, wherein the opening is located along a perimeter of the carrier.

16. The apparatus of claim 13, wherein the carrier has a maximum length and maximum width that is greater than a maximum length and maximum width of the electrochemical module.

17. The apparatus of claim 13, 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.

18. The apparatus of claim 13, wherein the carrier is folded along a fold line to define a top portion carrying the first conductive area and a bottom portion carrying the second conductive area.

19. The apparatus of claim 18, wherein the first and second conductive regions on the carrier are electrically isolated from one another along the fold line.

20. The apparatus of claim 18, wherein the opening is located along the fold line.

21. The apparatus of claim 13, 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.

22. The apparatus of claim 13, wherein the electrochemical module has opposed ends mounted on the carrier, and a mid-portion located between the opposed ends and spaced a distance apart from the carrier.

23. The apparatus of claim 13, 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.

24. The apparatus of claim 13, wherein the carrier is electrochemically non-functional.

25. An electrochemical sensor apparatus, 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 in electrical communication with the second conductive region, and

a proximal cut-out extending through a proximal end of the bottom insulating substrate to expose a contact area on the first conductive region of the top insulating substrate such that the first contact area and a second contact area on the bottom insulating substrate are exposed to allow electrical connection with an analyte measurement device to establish a connection between the first and second electrodes and the analyte measurement device.

26. An electrochemical module, comprising:

a first insulating substrate carrying a first electrode and a second insulating substrate carrying a second electrode, the first and second insulating substrates each having opposed sidewalls extending between first and second terminal ends, and an axis extending between the first and second terminal ends, and the first and second insulating substrates being offset from one another such that a first terminal end of the first insulating substrate extends a distance beyond a first terminal end of the second insulating substrate to expose the first electrode, and a second terminal end of the second insulating substrate extends a distance beyond a second terminal end of the first insulating substrate to expose the second electrode, and the first and second insulating substrates each having a width extending between the first and second terminal ends that is at least twice a length extending between the opposed sidewalls;

at least one spacer disposed between the first and second insulating substrates and maintaining the first and second electrodes in a spaced apart relationship with one another; and

an electrochemical cavity formed between the first and second electrodes and configured to receive a fluid sample, the electrochemical cavity include a reagent configured to react with an analyte of a fluid sample received in the electrochemical cavity.

27. The electrochemical module of claim 26, wherein the at least one spacer comprises a first spacer positioned adjacent to the first terminal end of the second insulating substrate, and a second spacer positioned adjacent to the second terminal end of the first insulating substrate.

28. 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

a plurality of electrochemical modules, each module being mounted across one of the plurality of openings, and 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.

29. The carrier web of claim 28, wherein the carrier includes a longitudinally extending fold line defining a top portion carrying the first conductive area and a bottom portion carrying the second conductive area.

30. A method for manufacturing an electrochemical sensing apparatus, comprising:

positioning opposed ends of an electrochemical module on a carrier such that an electrochemical cavity formed in the electrochemical module is positioned across an opening formed in the carrier; and

folding the carrier to engage the opposed ends of the electrochemical module between top and bottom portions of the carrier.

31. The method of claim 30, wherein the electrochemical module includes a first insulating substrate carrying a first electrode that is positioned in electrical contact with a first electrically conductive region on the carrier, and a second insulating substrate carrying a second electrode that is positioned in electrical contact with a second electrically conductive region on the carrier.

32. The method of claim 30, further comprising, prior to positioning, forming first and second electrically conductive regions on the carrier such that the first and second electrically conductive regions are electrically isolated from one another.

33. The method of claim 32, wherein, when the carrier is folded, the first electrically conductive region is on the top portion of the carrier and the second electrically conductive region is on the bottom portion of the carrier.

34. The method of claim 30, further comprising, prior to folding, positioning a spacer on the carrier such that the spacer maintains the top and bottom portions at a distance apart from one another when the carrier is folded.