ELECTROCHEMICAL SENSORS AND A METHOD FOR THEIR MANUFACTURE

• US 20140311903A1
• Filed: 09/07/2012
• Published: 10/23/2014
• Est. Priority Date: 09/07/2012
• Status: Active Grant

• Current Assignee: LifeScan IP Holdings, LLC
• Original Assignee: Cilag Gmbh International (Johnson & Johnson)
• Inventors: Setford, Steven John, Sloss, Scott J.
• Granted Patent: US 9,810,657 B2
• Time in Patent Office: Days
• US Class Current: 204/400
• CPC Class Codes: G01N 27/3272 Test elements therefor, i.e. disposable laminated substrates with electrodes, reagent and channels optical biosensors G01N33/52

Abstract

The invention provides electrochemical-based modules useful for the determination of an analyte in a bodily fluid sample. The modules of the invention provide opposed electrodes, but the contact areas for making electrical contact between the electrodes and the analyte measurement device are coplanar.

Claims

1. An electrochemical module, comprising:

a first substrate having a first conductive layer thereon and forming a first substrate-conductive layer assembly wherein the assembly has a first width and a first length;

a second substrate having a second conductive layer thereon and forming a second substrate-conductive layer assembly wherein the assembly has a second width that is less than the first width and a second length that is substantially the same as the first length wherein the first and second conductive layers are in a facing relationship;

a first and a second spacer disposed between the first and second assemblies and maintaining the assemblies in a spaced apart relationship;

a chamber formed between the first and second assemblies and configured to receive a fluid sample, wherein the chamber comprises a reagent capable of reacting with an analyte in the fluid sample; and

and a third spacer adjacent to one of the first or second spacers, a surface of the third spacer comprising a conductive layer that is in electrically conductive contact with the second conductive layer.

2. The module of claim 1, wherein the first width is about 3 mm to about 48 mm, and more preferably about 6 mm to about 10 mm, and the first length is about 0.5 mm to about 20 mm, more preferably about 1 to 4 mm.

3. The module of claim 1 or 2, wherein the chamber comprises a size such that the fluid volume within the chamber is from about 0.1 micro-liters to about 5 micro-liters.

4. The module of claim 1, wherein the first and second conductive layers comprise a metal selected from the group consisting of gold, palladium, platinum, tin-oxide, iridium, indium, titanium-palladium alloys, and combinations thereof.

5. The module of claim 4, wherein the first and second conductive layers comprise the same metal.

6. The module of claim 1, wherein one the first and second conductive layers comprises palladium and one of the first and second conductive layers comprises gold.

7. The module of claim 1, wherein the first and second conductive layers comprise a non-metal selected from the group consisting of carbon-based materials, carbon-based materials with electro-catalytic materials, graphene, and combinations thereof.

8. An electrochemical module, comprising

a first substrate having a first conductive layer thereon, the first conductive layer comprising a first and second portion having a gap therebetween, the first substrate and first conductive layer forming a first substrate-conductive layer assembly wherein the assembly has a first width and a first length;

a second substrate having a second conductive layer thereon and forming a second substrate-conductive layer assembly wherein the assembly has a second width that is less than the first width and a second length that is substantially the same as the first length wherein the first and second conductive layers are in a facing relationship;

a first and a second spacer disposed between the first and second assemblies and maintaining the assemblies in a spaced apart relationship;

a chamber formed between the first and second assemblies and configured to receive a fluid sample, wherein the chamber comprises a reagent capable of reacting with an analyte in the fluid sample; and

an electrically conductive third spacer adjacent to one of the first or second spacers, wherein the third spacer is in contact with at least a portion of the gap and in electrically conductive contact with the first and second conductive layers.

9. The module of claim 8, wherein the first width is about 3 mm to about 48 mm, and more preferably about 6 mm to about 10 mm, and the first length is about 0.5 mm to about 20 mm, more preferably about 1 to 4 mm.

10. The module of claim 8 or 9, wherein the chamber comprises a size such that the fluid volume within the chamber is from about 0.1 micro-liters to about 5 micro-liters.

11. The module of claim 8, wherein the first and second conductive layers comprise a metal selected from the group consisting of gold, palladium, platinum, tin-oxide, iridium, indium, titanium-palladium alloys, and combinations thereof.

12. The module of claim 11, wherein the first and second conductive layers comprise the same metal.

13. The module of claim 8, wherein one the first and second conductive layers comprises palladium and one of the first and second conductive layers comprises gold.

14. The module of claim 8, wherein the first and second conductive layers comprise a non-metal selected from the group consisting of carbon-based materials, carbon-based materials with electro-catalytic materials, graphene, and combinations thereof.