Reference electrodes having an extended lifetime for use in long term amperometric sensors

• US 8,280,474 B2
• Filed: 06/02/2008
• Issued: 10/02/2012
• Est. Priority Date: 06/02/2008
• Status: Active Grant

• Current Assignee: Abbott Diabetes Care Incorporated (Abbott Laboratories Incorporated)
• Original Assignee: Abbott Diabetes Care Incorporated (Abbott Laboratories Incorporated)
• Inventors: Liu, Zenghe, Feldman, Benjamin J., Cho, Brian, Hoss, Udo
• Primary Examiner(s): Yu, Melanie J
• Application Number:
  US12/131,759
• Publication Number:
  US 20090298104A1
• Time in Patent Office: 1,583 Days
• Field of Search: 600/309, 600/345, 600/347
• US Class Current: 600/345
• CPC Class Codes: A61B 5/14532 for measuring glucose, e.g. by tissue impedance measurement
• CPC Class Codes: A61B 5/1486 using enzyme electrodes, e.g. with immobilised oxidase
• CPC Class Codes: C12Q 1/006 for glucose
• CPC Class Codes: G01N 27/301 Reference electrodes
• 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 present application provides Ag/AgCl based reference electrodes having an extended lifetime that are suitable for use in long term amperometric sensors. Electrochemical sensors equipped with reference electrodes described herein demonstrate considerable stability and extended lifetime in a variety of conditions.

Claims

1. An electrochemical sensor, comprising:

a planar substrate;

a working electrode comprising a sensing layer in contact with a conductive material of the electrode and a membrane disposed over the sensing layer; and

a reference electrode comprising a layer of Ag/AgCl disposed over the working electrode; and

a layer of dielectric material having a width that is equal to the layer of Ag/AgCl and a length that is at least equal to the length of the layer of Ag/AgCl disposed on top of the layer of Ag/AgCl,

wherein the reference electrode is in electrochemical communication with the working electrode.

2. The electrochemical sensor of claim 1, wherein the sensing layer of the working electrode comprises a glucose-responsive enzyme.

3. The electrochemical sensor of claim 1, wherein the sensing layer of the working electrode comprises a redox mediator.

4. The electrochemical sensor of claim 3, wherein the redox mediator comprises a complex selected from the group consisting of a ruthenium-containing complex and an osmium-containing complex.

5. The electrochemical sensor of claim 3, wherein the redox mediator is non-leachable with respect to the working electrode.

6. The electrochemical sensor of claim 3, wherein the redox mediator is immobilized on the working electrode.

7. The electrochemical sensor of claim 1, wherein at least a portion of the electrochemical sensor is adapted to be subcutaneously positioned in a subject.

16. The electrochemical sensor of claim 1, further comprising a second dielectric layer disposed on at least a portion of the working electrode.

17. The electrochemical sensor of claim 16, wherein the reference electrode is disposed over the second dielectric layer.

18. The electrochemical sensor of claim 17, further comprising a counter electrode disposed on top of the first dielectric layer and a third dielectric layer disposed on top of the counter electrode.

8. An analyte sensor assembly, comprising:

an electrochemical sensor comprising a flexible substrate comprising

(i) at least one working electrode comprising a sensing layer and a membrane disposed over the sensing layer,

(ii) at least one reference electrode comprising a layer of Ag/AgCl disposed over the working electrode; and

first layer of dielectirc material having a width that is equal to the width of the layer of Ag/AgCl and a length that is at least equal to the length of the layer of Ag/AgCl disposed on top of the layer of Ag/AgCl,

(iii) at least one contact pad coupled to each of the working and reference electrodes,

wherein the electrochemical sensor is adapted for implantation of a portion of the electrochemical sensor comprising the working and reference electrodes through skin; and

an electrochemical sensor control unit comprising

(i) a housing adapted for placement on skin;

(ii) a plurality of conductive contacts disposed on the housing and configured for coupling to the contact pads of the electrochemical sensor; and

(iii) an rf transmitter disposed in the housing and coupled to the plurality of conductive contacts for transmitting data obtained using the electrochemical sensor.

9. The analyte sensor assembly of claim 8, wherein the sensing layer of the working electrode comprises a glucose-responsive enzyme.

10. The analyte sensor assembly of claim 8, wherein the sensing layer of the working electrode comprises a redox mediator.

11. The analyte sensor assembly of claim 8, wherein the redox mediator comprises a complex selected from the group consisting of a ruthenium-containing complex and an osmium-containing complex.

12. The analyte sensor assembly of claim 10, wherein the redox mediator is non-leachable with respect to the working electrode.

13. The analyte sensor assembly of claim 10, wherein the redox mediator is immobilized on the working electrode.

14. The analyte sensor assembly of claim 8, wherein the membrane limits flux of glucose or lactate thereacross.

15. The analyte sensor assembly of claim 8, wherein the membrane limits flux of glucose or lactose thereacross in vivo.

19. The analyte sensor assembly of claim 8, further comprising a second dielectric layer disposed on at least a portion of the working electrode.

20. The analyte sensor assembly of claim 19, wherein the reference electrode is disposed over the second dielectric layer.

21. The analyte sensor assembly of claim 20, further comprising a counter electrode disposed on top of the first dielectric layer and a third dielectric layer disposed on top of the counter electrode.