Method of measuring chemical concentration iontophoretically using impermeable mask

• US 5,827,183 A
• Filed: 10/29/1997
• Issued: 10/27/1998
• Est. Priority Date: 09/12/1995
• Status: Expired due to Term

• Current Assignee: Animas Technologies LLC (Johnson & Johnson)
• Original Assignee: Cygnus, Inc. (Johnson & Johnson)
• Inventors: Kurnik, Ronald T., Tamada, Janet, Tierney, Michael
• Primary Examiner(s): Bahr, Jennifer
• Assistant Examiner(s): HUANG, STEPHEN D
• Application Number:
  US08/959,599
• Time in Patent Office: 363 Days
• Field of Search: 604/20, 604/304-308, 600/345-348, 600/362, 600/365, 600/382, 600/307, 600/309, 600/386, 600/391, 600/395, 600/396, 600/397
• US Class Current: 600/345
• CPC Class Codes: A61B 5/1486 using enzyme electrodes, e.g. with immobilised oxidase
• CPC Class Codes: A61N 1/30 Apparatus for iontophoresis, i.e. transfer of media in ionic state by an electromotoric force into the body, or cataphoresis
• CPC Class Codes: C12Q 1/001 Enzyme electrodes
• CPC Class Codes: C12Q 1/002 Electrode membranes
• CPC Class Codes: C12Q 1/006 for glucose

Abstract

A method for measuring the concentration of a chemical present in a blood stream of a mammalian subject is disclosed. The method involves contacting the subject'"'"'s skin with a sensor assembly comprised of an ionically conducting material which contacts the skin, a working electrode which is in contact with the ionically conducting material which electrode has a catalytic surface and a mask having an opening therein. The mask is positioned between the skin and the working electrode. When the electrode is activated, chemical is transported through the skin and the ionically conductive material. The mask is positioned so that it blocks the flow into the catalytic surface except for flow which is substantially axially to the catalytic surface. Electrical signal generated at the working electrode is monitored over a period of time and correlated with a concentration of chemical present in the blood stream of the mammalian subject. The mask reduces or eliminates chemical signal which can radially transport toward the working electrode thereby reducing or eliminating edge effects making it possible to obtain a more accurate measurement.

Claims

1. A method of measuring a concentration of a chemical present in a bloodstream of a mammalian subject, comprising the steps of:

contacting a mammalian subject'"'"'s skin with a sensor assembly comprising;

a) an ionically conductive material in contact with the skin;

b) a working electrode in contact with the ionically conductive material the working electrode having a catalytic surface; and

c) a mask having an opening therein wherein the mask is positioned between the skin and the working electrode;

transporting a chemical through the skin and ionically conductive material whereby the mask blocks flow to the catalytic surface except for flow substantially axial to the catalytic surface;

monitoring an electrical signal generated at the working electrode by catalytic conversion into an electric signal at the catalytic surface of the working electrode;

wherein the electrical signal generated at the working electrode over a given period of time is correlated with a concentration of chemical present in the bloodstream of the mammalian subject.

2. The method of claim 1, wherein the assembly further comprises:

d) an electroosmotic electrode in contact with the ionically conductive material and said transporting is accomplished by applying an electrical current to the electroosmotic electrode.

3. The method of claim 1, wherein the chemical is glucose, the ionically conductive material is a hydrogel, and the catalytic surface of the working electrode comprises a material selected from the group consisting of platinum oxide and platinum dioxide.

4. The method of claim 3, wherein the hydrogel comprises a hydrophilic polymer, water and glucose oxidase.

5. The method of claim 4, wherein the mammalian subject is a human.

6. The method of claim 1, wherein the mammalian subject is a human.

7. The method of claim 1, wherein the chemical is glucose.

8. The method of claim 1, wherein the ionically conductive material comprises glucose oxidase.

9. The method of claim 1, wherein the catalytic surface of the working electrode is comprised of a material selected from the group consisting of platinum oxide and platinum dioxide.

10. The method of claim 1, wherein the mammalian subject is a human, the chemical is glucose, the ionically conductive material comprises glucose oxidase, and the surface of the working electrode is comprised of a material selected from the group consisting of platinum oxide and platinum dioxide.

11. A method of measuring a glucose concentration in a mammalian subject, comprising:

contacting a first surface of an ionically conductive material with a skin surface wherein the ionically conductive material comprises water and glucose oxidase;

contacting a second surface of the conductive material with a working electrode;

applying current to the skin in an amount sufficient to draw glucose into the conductive material whereby the glucose is converted to gluconic acid and hydrogen peroxide and the hydrogen peroxide is drawn to the working electrode; and

positioning a mask impermeable to the hydrogen peroxide between the skin surface and a surface of the working electrode so as to shield the working electrode surface from hydrogen peroxide moving to the working electrode surface via any path other than a path substantially axial to the working electrode surface.

12. The method of claim 11, wherein the mammalian subject is a human.

13. The method of claim 11, wherein the working electrode is comprised of a material selected from the group consisting of platinum oxide and platinum dioxide.