Electrochemical sensor with dual purpose electrode

• US 5,954,685 A
• Filed: 05/24/1996
• Issued: 09/21/1999
• Est. Priority Date: 05/24/1996
• Status: Expired due to Term

• Current Assignee: Animas Technologies LLC (Johnson & Johnson)
• Original Assignee: Cygnus, Inc. (Johnson & Johnson)
• Inventors: Tierney, Michael J.
• Primary Examiner(s): Bockelman, Mark
• Application Number:
  US08/653,161
• Time in Patent Office: 1,215 Days
• Field of Search: 128/632, 128/635, 128/637, 128/639, 128/760, 604/20, 600/310, 600/322-323, 600/368, 600/573, 600/347, 600/355, 600/362
• US Class Current: 604/20
• CPC Class Codes: A61B 5/1486 using enzyme electrodes, e.g. with immobilised oxidase

Abstract

The present invention provides an electrode assembly for use in a transdermal analyte sensor operating in an alternating polarity mode in which a single electrode element provides both the counter electrode and iontophoretic electrode functions. By combining both the functions of the iontophoretic and counter electrode, the surface area of the electrode with respect to each function may be made larger. In turn this increases the ability of the electrode to deliver the required electrical field over a larger area when operating in the iontophoretic mode as well as increasing the ability of the counter electrode to compensate for the larger sensing electrode facilitated by this new design.

Claims

1. An integral electrode assembly for use in a transcutaneous reverse-iontophoresis diagnostic system wherein chemical signals are extracted through the surface of a patient'"'"'s skin by application of an electrical field, said assembly comprising:

(a) a pair of electrically connected iontophoretic electrodes adapted for applying electrical current to the skin to extract chemical signals therefrom;

(b) a first sensing electrode positioned adjacent one of the iontophoretic electrodes for detecting the chemical signals extracted thereby;

wherein the first sensing electrode is electrically connected with said iontophoretic electrode such that said iontophoretic electrode serves as a counter electrode therefor and defines a first sensor electrode pair.

2. The electrode assembly of claim 1 further comprising a second sensing electrode positioned opposite the first sensor electrode pair and adjacent the remaining iontophoretic electrode for detecting the chemical species extracted thereby, wherein the second sensing electrode is electrically connected to the adjacent iontophoretic electrode such that said iontophoretic electrode serves as a counter electrode therefor and defines a second sensor electrode pair.

3. The electrode assembly of claim 2 wherein the iontophoretic and sensing electrodes are located upon a planar substrate.

4. The electrode assembly of claim 3 wherein the substrate comprises a polymeric or ceramic material.

5. The electrode assembly of claim 4 wherein the substrate is a plastic film.

6. The electrode assembly of claim 2 further comprising a first and second reference electrode positioned adjacent to the first and second sensor electrode pairs, respectively.

7. The electrode assembly of claim 2 further comprising a first ionically conductive material having a first surface adapted to contact the surface of the skin and a second surface opposite the first surface which is in contact with the first sensor electrode pair.

8. The electrode assembly of claim 7 further comprising a second ionically conductive material having a first surface adapted to contact the surface of the skin and a second surface opposite the first surface which is in contact with the second sensor electrode pair.

14. The electrode assembly of claim 7 wherein the ionically conductive material comprises a hydrogel.

15. The electrode assembly of claim 14 wherein the hydrogel comprises water, glucose oxidase and an electrolyte and wherein the chemical signal is glucose.

16. The electrode assembly of claim 1 wherein the first sensing electrode comprises a platinum containing catalytic surface and the iontophoretic electrodes are comprised of Ag/AgCl.

17. The electrode assembly of claim 1 wherein the first sensor electrode pair operate at a current level in the range of 1 nanoamp to 1 milliamp and the iontophoretic electrode pair operate at a current level in the range of 1 nanoamp to 5 milliamps.

18. The electrode assembly of claim 1 further including a monitoring device.

9. A method of determining the concentration of a chemical signal in a mammalian subject using the transcutaneous reverse-iontophoresis diagnostic system of claim 22, said method comprising the steps of:

(a) contacting the first surfaces of the first and second ionically conductive materials to the skin of the mammalian subject;

(b) providing a current between the iontophoretic electrode pair to extract the chemical signal through the skin and into the first ionically conductive material;

(c) providing a potential between the first sensor electrode pair sufficient to drive an electrochemical conversion of the chemical signal contained within the first ionically conductive material and measuring the electrical current generated by this electrochemical conversion of chemical signal; and

(d) correlating the measured current in step (c) to a concentration of chemical signal in the subject.

10. The method of claim 9 wherein after step (d) the method further comprises the steps of:

(e) switching the polarity between the iontophoretic electrode pair and providing current to extract the chemical signal through the skin and into the second ionically conductive material;

(f) providing a potential between the second sensor electrode pair sufficient to drive an electrochemical conversion of the chemical signal contained within the second ionically conductive material, and measuring the electrical current generated by this electrochemical conversion of the chemical signal; and

(g) correlating the measured current of step (f) to a concentration of chemical signal in the subject.

11. The method of claim 10 wherein the chemical signal is glucose and wherein the ionically conductive material is a hydrogel comprising water, glucose oxidase and an electrolyte.

12. The method of claim 9 wherein the sensing electrodes include a platinum containing catalytic surface and the iontophoretic electrodes are comprised of Ag/AgCl.

13. The method of claim 9 wherein the first sensor electrode pair is operated at a current level in the range of 1 nanoamp to 1 milliamp and the iontophoretic electrode pair are operated at a current level in the range of 1 nanoamp to 5 milliamps.