Electrochemical biosensor

• US 5,759,364 A
• Filed: 05/02/1997
• Issued: 06/02/1998
• Est. Priority Date: 05/02/1997
• Status: Expired due to Term

• Current Assignee: Bayer Healthcare LLC (Bayer AG)
• Original Assignee: Bayer Corporation (Bayer AG)
• Inventors: Deng, Yingping, Johnson, Larry D., Venosky, James J., Charlton, Steven C., Hildenbrand, Karl-Heinz
• Primary Examiner(s): Bell, Bruce F.
• Application Number:
  US08/850,608
• Time in Patent Office: 396 Days
• Field of Search: 204/403, 435/817, 435/287.1, 435/289.1, 156/102, 156/106, 156/107, 156/196, 156/217, 156/219, 156/220
• US Class Current: 204/403.14
• CPC Class Codes: C12Q 1/001 Enzyme electrodes
• CPC Class Codes: C12Q 1/002 Electrode membranes
• CPC Class Codes: Y10S 435/817 Enzyme or microbe electrode
• CPC Class Codes: Y10T 156/1002 with permanent bending or reshaping or surface deformation of self sustaining lamina
• CPC Class Codes: Y10T 156/1036 Bending of one piece blank and joining edges to form article
• CPC Class Codes: Y10T 156/1039 Surface deformation only of sandwich or lamina [e.g., embossed panels]
• CPC Class Codes: Y10T 156/1041 Subsequent to lamination

Abstract

Disclosed is an electrochemical sensor which is made up of an insulating base plate bearing an electrode on its surface which reacts with an analyte to produce mobile electrons. The base plate is mated with a lid of a deformable material which has a concave area surrounded by a flat surface so that when mated to the base plate there is formed a capillary space into which a fluid test sample can be drawn. The side of the lid facing the base is coated with a polymeric material which serves to bond the lid to the base plate and to increase the hydrophilic nature of the capillary space.

Claims

1. An electrochemical sensor for the detection of an analyte in a fluid test sample which comprises:

a) an insulating base plate;

b) an electrode layer on said base plate in operative connection with an enzyme which reacts with the analyte to produce mobile electrons; and

c) a lid of deformable material which has been embossed to provide a concave area in a portion thereof while leaving a flat surface surrounding the concave portion in such a configuration that, when mated with the base, the lid and base form a capillary space in which the enzyme is available for direct contact with fluid test sample which is drawn into the capillary space by capillary action, wherein said sensor has a polymeric layer over the underside of the lid to facilitate bonding of the lid to the base upon their being mated and to increase the hydrophilic nature of the capillary space.

2. The sensor of claim 1 wherein the polymeric layer comprises a surfactant stabilized polyurethane.

3. The sensor of claim 1 wherein the polymer layer comprises a water dispersible polyurethane ionomer.

4. The sensor of claim 3 wherein the polyurethane ionomer is anionic.

5. The sensor of claim 4 wherein the polyurethane ionomer is a linear aliphatic polyester urethane based on hexamethylene diisocyanate and isophorone diisocyanate.

6. The sensor of claim 1 wherein the polymer is a vinylacetate-ethylene co-polymer.

7. The sensor of claim 1 wherein there is an electrical conducting layer on the surface of the insulating base plate and the electrode layer is on the surface of the conducting layer and in electrically conductive contact therewith.

8. The sensor of claim 1 wherein the lid is mated to the base with direct contact between the lid and the base being at the electrode surface and the under side of the lid.

9. The sensor of claim 1 wherein there is a layer of dielectric material patterned over the electrode layer so that only a portion of the electrode, as predetermined by the pattern of the dielectric layer, is available for direct contact with the fluid test sample.

10. The sensor of claim 9 wherein the lid is configured so that its edges mate with the dielectric layer.

11. The sensor of claim 9 wherein the dielectric layer is configured so that it leaves a portion of the electrode layer exposed for direct contact with the flat surfaces of the lid.

12. The sensor of claim 1 wherein the enzyme is an oxidoreductase.

13. A method of making an electrochemical sensor for the detection of an analyte in a fluid test sample which comprises:

a) providing an insulating base plate which has on its surface an electrode layer in operative connection with an enzyme which reacts with the analyte to produce mobile electrons; and

b) mating the base plate with a lid of a deformable material a part of which encompasses a concave area with a flat surface surrounding the concave portion in such a configuration that, when mated with the base, the lid and base form a capillary space in which the enzyme is available for direct contact with the fluid test sample in the capillary space and the lid has a polymeric layer over the underside thereof to facilitate bonding of the lid to the base and increase the hydrophilic nature of the capillary space; and

c) heating the base plate and lid while applying pressure therebetween to fuse the base plate to the lid.

14. The method of claim 13 wherein there is a layer of dielectric material patterned over the electrode layer so that only a portion of the electrode, as predetermined by the pattern of the dielectric layer, is available for direct contact with the fluid test sample.

15. The method of claim 13 wherein the dielectric layer is configured so that the flat surfaces of the lid mate solely with the dielectric layer.

16. The method of claim 13 wherein the dielectric layer is configured so that it leaves at least a portion of the electrode layer exposed for direct contact with the flat surfaces of the lid.

17. The method of claim 13 wherein the polymeric layer on the underside of the lid comprises a surfactant stabilized polyurethane.

18. The method of claim 13 wherein the polymer layer comprises a water dispersible polyurethane ionomer.

19. The method of claim 18 wherein the polyurethane ionomer is anionic.

20. The method of claim 19 wherein the anoinic polyurethane ionomer is a linear aliphatic polyester urethane based on hexamethylene diisocyanate and isophorone diisocyanate.