Electrochemical sensors and a method for their manufacture

• US 9,810,657 B2
• Filed: 09/07/2012
• Issued: 11/07/2017
• 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.
• Primary Examiner(s): Kaur, Gurpreet
• Application Number:
  US14/002,956
• Publication Number:
  US 20140311903A1
• Time in Patent Office: 1,887 Days
• 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 first substrate-conductive layer 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 second substrate-conductive layer 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 substrate-conductive layer assembly and second substrate-conductive layer assembly and maintaining the first substrate-conductive layer assembly and second substrate-conductive layer assembly in a spaced apart relationship, the first and second spacers extending along the first length;

a chamber formed between the first substrate-conductive layer assembly and second substrate-conductive layer assembly and configured to receive a fluid sample, the chamber comprising a first sidewall defined by a second latitudinal end of the first spacer and a second sidewall defined by a first latitudinal end of the second spacer, wherein the chamber comprises a reagent capable of reacting with an analyte in the fluid sample; and

a third spacer adjacent to and in physical contact with the second latitudinal end, opposite the first latitudinal end, of the second spacer, a surface of the third spacer comprising a conductive layer that is in a facing relationship and in electrically conductive contact with the second conductive layer, the third spacer extending along the first length.

2. The module of claim 1, wherein the first width of the first substrate-conductive layer assembly is about 3 mm to about 48 mm, and the first length of the first substrate-conductive layer assembly is about 0.5 mm to about 20 mm.

3. The module of claim 1 or 2, wherein the chamber comprises a size such that a 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 of 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.

15. The module of claim 1, wherein the first width of the first substrate-conductive layer assembly is about 6 mm to about 10 mm, and the first length of the substrate-conductive layer assembly is about 1 to 4 mm.

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 first substrate-conductive layer 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 second substrate-conductive layer 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 substrate-conductive layer assembly and second substrate-conductive layer assembly and maintaining the first substrate-conductive layer assembly and second substrate-conductive layer assembly in a spaced apart relationship, the first and second spacers extending along the first length;

a chamber formed between the first substrate-conductive layer assembly and second substrate-conductive layer assembly and configured to receive a fluid sample, the chamber comprising a first sidewall defined by a second latitudinal end of the first spacer and a second sidewall defined by a first latitudinal end of the second spacer, wherein the chamber comprises a reagent capable of reacting with an analyte in the fluid sample; and

an electrically conductive third spacer adjacent to the second latitudinal end, opposite the first latitudinal end, of the second spacer, 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, the third spacer extending along the first length.

9. The module of claim 8, wherein the first width of the first substrate-conductive layer assembly is about 3 mm to about 48 mm, and the first length of the first substrate-conductive layer assembly is about 0.5 mm to about 20 mm.

10. The module of claim 8 or 9, wherein the chamber comprises a size such that a 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 of 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.

16. The module of claim 8, wherein the first width of the first substrate-conductive layer assembly is about 6 mm to about 10 mm, and the first length of the first substrate-conductive layer assembly is about 1 to 4 mm.