Electrodes having at least one sensing structure and methods for making and using the same

• US 10,598,624 B2
• Filed: 10/22/2015
• Issued: 03/24/2020
• Est. Priority Date: 10/23/2014
• Status: Active Grant

• Current Assignee: Abbott Diabetes Care Incorporated (Abbott Laboratories Incorporated)
• Original Assignee: Abbott Diabetes Care Incorporated (Abbott Laboratories Incorporated)
• Inventors: Hoss, Udo, Khan, Tahir Sadik, Le, Phu X.
• Primary Examiner(s): Ball, J. Christopher
• Application Number:
  US15/520,784
• Publication Number:
  US 20170363564A1
• Time in Patent Office: 1,615 Days
• CPC Class Codes: A61B 5/1486 using enzyme electrodes, e.g. with immobilised oxidase
• CPC Class Codes: G01N 27/3271 Amperometric enzyme electrodes for analytes in body fluids, e.g. glucose in blood amperometry per se G01N27/49; aspects concerning the enzyme reagent C12Q1/001
• CPC Class Codes: G01N 27/413 Concentration cells using liquid electrolytes measuring currents or voltages in voltaic cells
• CPC Class Codes: H01M 4/02 Electrodes composed of, or comprising, active material

Abstract

Embodiments of the present disclosure relate to electrochemical analyte sensor electrodes that have one or more sensing structures, each structure has a respective perimeter at least partially around it to define the structure so that each of the structures have a liquid limiting barrier around their perimeters. The liquid limiting perimeter may completely or partially encompass the perimeter of each sensing structure of the electrode. Also provided are methods for fabricating the electrodes, analyte sensors employing the subject electrodes, and methods of using the analyte sensors in analyte monitoring.

Claims

1. An electrode comprising:

a non-conductive material;

a conductive layer disposed on the non-conductive material, the conductive layer comprising a conductive material; and

two or more sensing structures on the conductive layer, forming an array thereof, wherein a removed portion of conductive material forms a fluid barrier perimeter surrounding each of the two or more sensing structures; and

reagent comprising analyte responsive enzyme positioned within the sensing structure.

2. The electrode according to claim 1, wherein the fluid barrier perimeter is an incomplete circle around each of the two or more sensing structures.

3. The electrode according to claim 2, wherein the circle is incomplete by 50 μ

m or less.

4. The electrode according to claim 1, wherein the fluid barrier perimeter is at least a single portion of removed conductive material.

5. The electrode according to claim 1, wherein the fluid barrier perimeter has a depth from 1 μ

m to 25 μ

m.

6. A method comprising:

determining a level of an in vivo analyte over a period of time from signals generated by an analyte sensor, wherein the analyte sensor comprises;

a working electrode; and

a counter electrode,

wherein the working electrode comprises;

a non-conductive material;

a conductive layer disposed on the non-conductive material, the conductive layer comprising a conductive material; and

two or more sensing structures on the conductive layer, wherein a removed portion of conductive material forms a fluid barrier perimeter surrounding each of the two or more sensing structures; and

a reagent comprising analyte responsive enzyme positioned within the sensing structure; and

wherein the determining over a period of time provides for monitoring the level of the analyte.

7. The method according to claim 6, wherein the conductive layer has a thickness of from 50 μ

m to 200 μ

m.

8. The method according to claim 6, wherein the removed portion of conductive material spans an entire thickness of the conductive layer.

9. The method according to claim 6, wherein the removed portion of conductive material is less than an entire thickness of the conductive layer.

10. The method according to claim 6, wherein the array comprises 100 or more individual sensing structures.

11. The method according to claim 6, wherein the array comprises sensing structures in an area of from 0.1 to 1000 per mm².

12. A method of fabricating an electrode, the method comprising:

applying a conductive material to a surface of a second material to form a conductive layer;

removing a first portion of the conductive material to define an electrode on the surface of the second material;

removing a second portion of the conductive material within the electrode to form two or more sensing structure, forming an array thereof, having a removed portion of conductive material forming a fluid barrier perimeter surrounding each of the two or more sensing structures; and

depositing a reagent comprising an analyte responsive enzyme within the two or more sensing structures of the electrode.

13. The method according to claim 12, wherein removing the second portion of the conductive material to form the two or more sensing structures having the removed portion of conductive material forming the fluid barrier perimeter results in exposing the surface of the second material at the fluid barrier perimeter.

14. The method according to claim 12, wherein removing the first portion of the conductive material to define the electrode is performed concurrently with removing the second portion of the conductive layer within the electrode to form the two or more sensing structures having the removed portion of conductive material forming the fluid barrier perimeter.

15. The method according to claim 12, wherein removing the second portion of the conductive material within the electrode to form the two or more sensing structures having the removed portion of conductive material forming the fluid barrier perimeter is performed after the removing first portion of the conductive layer to define the electrode on the surface of the second material.

16. The method according to claim 12, wherein removing the first or second portion of the conductive material comprises laser ablation.

17. The method according to claim 16, wherein the fluid barrier perimeter is an incomplete circle around each of the two or more sensing structures.

18. The method according to claim 12, wherein the surface is roughened in a manner sufficient to provide an average peak height of 1 μ

m.