Electrochemical sensor system using a substrate with at least one aperture and method of making the same

• US 9,668,683 B2
• Filed: 12/21/2006
• Issued: 06/06/2017
• Est. Priority Date: 12/27/2005
• Status: Active Grant

• Current Assignee: Ascensia Diabetes Care Holdings AG (PHC Holdings Corporation)
• Original Assignee: Ascensia Diabetes Care Holdings AG (PHC Holdings Corporation)
• Inventors: Rebec, Mihailo V., Brenneman, Allen J.
• Primary Examiner(s): WEARE, MEREDITH H
• Application Number:
  US12/087,087
• Publication Number:
  US 20090184000A1
• Time in Patent Office: 3,820 Days
• Field of Search: 600345
• CPC Class Codes: A61B 5/14507 specially adapted for measuring characteristics of body fluids other than blood devices for taking samples of body liquids A61B10/0045
• CPC Class Codes: A61B 5/14532 for measuring glucose, e.g. by tissue impedance measurement
• CPC Class Codes: A61B 5/14546 for measuring analytes not otherwise provided for, e.g. ions, cytochromes
• CPC Class Codes: A61B 5/1468 using chemical or electrochemical methods, e.g. by polarographic means A61B5/1486 takes precedence
• CPC Class Codes: A61B 5/1477 non-invasive
• CPC Class Codes: C12Q 1/006 for glucose
• CPC Class Codes: Y10T 29/49124 On flat or curved insulated base, e.g., printed circuit, etc.

Abstract

An electrochemical sensor system is adapted to assist in determining an analyte concentration of a fluid. The electrochemical sensor system comprises a substrate, conductive material and a hydrogel or liquid. The substrate having porosity therethrough. The conductive material includes at least one electrode. The at least one electrode is coupled to the substrate. The at least one electrode has a first surface and an opposing second surface. The hydrogel or liquid is adapted to assist in carrying the analyte of the fluid to the first and second surfaces of the at least one electrode.

Claims

1. An electrochemical test sensor for determining a concentration of an analyte of a fluid, the electrochemical test sensor comprising:

a substrate having porosity including at least one aperture extending through the substrate;

an enzyme coupled to the substrate, the enzyme being configured to chemically react with the analyte in the fluid;

at least one conductive electrode coupled to the substrate, each electrode of the at least one electrode having a first surface and a second surface on the opposite side of the first surface; and

a hydrogel extending through the at least one aperture and contacting the first and second surfaces of the at least one electrode and the substrate, the hydrogel being configured to carry the analyte of the fluid into contact with both the first and second surfaces of the at least one electrode,

wherein the hydrogel comprises a first layer and a second layer, and the at least one electrode and the substrate are sandwiched between the first and second layers of the hydrogel.

2. The electrochemical test sensor of claim 1, wherein the at least one electrode extends into and through the at least one aperture.

3. The electrochemical test sensor of claim 1, wherein the at least one electrode circumscribes the at least one aperture.

4. The electrochemical test sensor of claim 1, wherein the at least one electrode spans across the at least one aperture.

5. The electrochemical test sensor of claim 1, wherein the at least one electrode comprises a plurality of electrodes including a working electrode and a counter electrode mounted on an outer surface of the substrate, the hydrogel contacting the opposing first and second surfaces of the working and counter electrodes.

6. The electrochemical test sensor of claim 1, wherein the at least one electrode is mounted on an outer surface of or seated at least partially within the substrate.

7. The electrochemical test sensor of claim 1, wherein the substrate is a screen, scrim, woven material, or solid material, or any combination thereof, each with multiple apertures extending therethrough.

8. The electrochemical test sensor of claim 1, wherein the hydrogel is a cross-linked polymer.

9. The electrochemical test sensor of claim 1, wherein the hydrogel covers the first and second surfaces of the at least one electrode.

10. The electrochemical test sensor of claim 1, wherein the at least one electrode is embedded within the substrate.

11. A method of forming an electrochemical test sensor for determining a concentration of an analyte, the method comprising:

providing a substrate having porosity including at least one aperture extending through the substrate;

adding an enzyme to the substrate, the enzyme being configured to chemically react with the analyte;

adding conductive material to the substrate to form at least one electrode, each electrode of the at least one electrode having a first surface on an opposing side of a second surface; and

adding a hydrogel to the substrate such that the hydrogel extends through the at least one aperture and contacts the first and second surfaces of the at least one electrode and the substrate, the hydrogel being configured to carry the analyte into contact with both the first and second surfaces of the at least one electrode,

wherein the hydrogel comprises a first layer and a second layer, and the at least one electrode and the substrate are sandwiched between the first and second layers of the hydrogel.

12. The method of claim 11, wherein the at least one electrode extends into and through the at least one aperture.

13. The method of claim 11, wherein the at least one electrode circumscribes the at least one aperture.

14. The method of claim 11, wherein the step of adding the conductive material to the substrate to form at least one electrode comprises forming a plurality of electrodes including a working electrode and a counter electrode mounted on an outer surface of the substrate, the hydrogel contacting the opposing first and second surfaces of the working and counter electrodes.

15. The method of claim 11, wherein the substrate includes multiple apertures extending therethrough, the hydrogel extending through the multiple apertures.

16. The method of claim 11, wherein the at least one electrode is embedded within the substrate.

17. A sensor assembly for assisting in determining a concentration of an analyte of a fluid, the sensor assembly comprising:

a rigid, non-conductive substrate having apertures extending therethrough;

an enzyme attached to the substrate and configured to react with the analyte in the fluid;

a plurality of electrically conductive electrodes attached to the substrate, each electrode of the plurality of electrodes having a first surface on the opposite side of a second surface; and

a hydrogel composition extending through the apertures and contacting the first and second surfaces of the electrically conductive electrodes, the hydrogel composition being configured to carry the analyte of the fluid into contact with the first and second surfaces of the electrically conductive electrodes,

wherein the hydrogel composition comprises a first layer and a second layer, and the electrodes and the substrate are sandwiched between the first and second layers of the hydrogel composition.

18. The sensor assembly of claim 17, wherein one or more of the electrically conductive electrodes extends into and through at least one of the apertures.

19. The sensor assembly of claim 17, wherein one or more of the electrically conductive electrodes circumscribes at least one of the apertures.