Subcutaneous glucose electrode

• US 6,881,551 B2
• Filed: 01/28/2003
• Issued: 04/19/2005
• Est. Priority Date: 03/04/1991
• Status: Expired due to Fees

• Current Assignee: Therasense Incorporated (Abbott Laboratories Incorporated)
• Original Assignee: Therasense Incorporated (Abbott Laboratories Incorporated)
• Inventors: Heller, Adam, Pishko, Michael V.
• Primary Examiner(s): Leary, Louise N.
• Application Number:
  US10/353,341
• Publication Number:
  US 20030134347A1
• Time in Patent Office: 812 Days
• Field of Search: 435/14, 435/4, 435/25, 435/28, 435/817, 435/289.1, 436/36, 436/63, 436/149
• US Class Current: 435/14
• 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: A61B 5/1495 Calibrating or testing of in-vivo probes
• CPC Class Codes: C12Q 1/006 for glucose
• CPC Class Codes: C12Q 1/54 involving glucose or galactose
• CPC Class Codes: Y10S 435/817 Enzyme or microbe electrode
• CPC Class Codes: Y10S 435/917 Aspergillus niger
• CPC Class Codes: Y10S 435/962 Prevention or removal of interfering materials or reactants or other treatment to enhance results, e.g. determining or preventing nonspecific binding

Abstract

A small diameter flexible electrode designed for subcutaneous in vivo amperometric monitoring of glucose is described. The electrode is designed to allow “one-point” in vivo calibration, i.e., to have zero output current at zero glucose concentration, even in the presence of other electroreactive species of serum or blood. The electrode is preferably three or four-layered, with the layers serially deposited within a recess upon the tip of a polyamide insulated gold wire. A first glucose concentration-to-current transducing layer is overcoated with an electrically insulating and glucose flux limiting layer (second layer) on which, optionally, an immobilized interference-eliminating horseradish peroxidase based film is deposited (third layer). An outer (fourth) layer is biocompatible.

Claims

1. An electrode comprising:

a non-corroding, conducting base electrode;

a multilayered polymeric composition disposed on the base electrode, the composition comprising;

a sensing layer adjacent to and contacting the base electrode, the sensing layer comprising a redox enzyme crosslinked to a redox polymer;

an analyte diffusion limiting layer disposed on the sensing layer; and

a biocompatible polymer layer disposed on the analyte diffusion limiting barrier layer.

2. The electrode of claim 1 further comprising an interferent eliminating layer disposed on the biocompatible polymer layer.

3. The electrode of claim 2, wherein the interference eliminating layer comprises a peroxidase enzyme.

4. The electrode of claim 1, wherein the non-corroding, conducting base electrode is a non-corroding metal or carbon base electrode.

5. The electrode of claim 4, wherein the non-corroding metal is gold.

6. The electrode of claim 1, wherein the analyte diffusion limiting layer is a glucose diffusion limiting layer.

7. The sensor of claim 1, wherein the analyte diffusion limiting layer comprises a polyanionic, polycationic, or zwitterionic polymer.

8. The electrode of claim 1, wherein each of the sensing layer, the analyte diffusion limiting layer, and the biocompatible layer are non-leachable.

9. The electrode of claim 1, wherein the biocompatible layer comprises a biocompatible hydrogel.

10. The electrode of claim 1, wherein the redox polymer of the sensing layer is derived from poly(1-vinylimidazole) or a copolymer of (1-vinyl imidazole) bound to a metal ion selected from the group consisting of Os^3+/2+, Ru^3+/2+Fe^3+/2+.

11. The electrode of claim 1, wherein the redox enzyme is glucose oxidase.

12. An electrode comprising:

a non-corroding metal or carbon base electrode;

a non-leachable sensing layer coupled to the base electrode;

a glucose flux-limiting layer coupled to the sensing layer; and

a biocompatible layer bound to the glucose flux-limiting layer.

13. The electrode of claim 12 further comprising an interferent eliminating layer disposed on the biocompatible polymer layer.

14. The electrode of claim 13, wherein the interference eliminating layer comprises a peroxidase enzyme.

15. The sensor of claim 12, wherein the glucose flux-limiting layer comprises a polyanionic, polycationic, or zwitterionic polymer.

16. The electrode of claim 12, wherein the glucose flux-limiting layer and the biocompatible layer are non-leachable.

17. The electrode of claim 12, wherein the biocompatible layer comprises a biocompatible hydrogel.

18. The electrode of claim 12, wherein the non-leachable sensing layer comprises a redox enzyme crosslinked to a redox polymer.

19. The electrode of claim 18, wherein the redox polymer is derived from poly(1-vinylimidazole) or a copolymer of (1-vinyl imidazole) bound to a metal ion selected from the group consisting of Os^3+/2+, Ru^3+/2+, and Fe^3+/2+.

20. The electrode of claim 18, wherein the redox enzyme is glucose oxidase.