Strip electrode with screen printing

• US 5,820,551 A
• Filed: 06/06/1995
• Issued: 10/13/1998
• Est. Priority Date: 05/05/1983
• Status: Expired due to Term

• Current Assignee: Abbott Laboratories Incorporated
• Original Assignee: Abbott Laboratories Incorporated
• Inventors: Davis, Graham, Hill, Hugh Allen Oliver, Higgins, Irving John, McCann, James Michael
• Primary Examiner(s): Shay, David M.
• Application Number:
  US08/470,352
• Time in Patent Office: 1,225 Days
• Field of Search: 128/633, 128/634, 128/637, 128/692, 128/639, 204/153.1, 204/153.12, 204/402, 204/403, 204/406, 204/407, 204/435, 600/309, 600/345, 600/347, 600/348, 600/365, 600/368
• US Class Current: 204/403.04
• CPC Class Codes: A61B 2560/0418 Pen-shaped housings
• CPC Class Codes: A61B 5/1486 using enzyme electrodes, e.g. with immobilised oxidase
• CPC Class Codes: A61B 5/14865 invasive, e.g. introduced into the body by a catheter or needle or using implanted sensors
• CPC Class Codes: A61B 5/6848 Needles
• CPC Class Codes: C12Q 1/001 Enzyme electrodes
• CPC Class Codes: C12Q 1/004 mediator-assisted
• CPC Class Codes: G01N 27/4035 Combination of a single ion-sensing electrode and a single reference electrode G01N27/406 and G01N27/413 take precedence
• CPC Class Codes: G01N 33/5438 Electrodes

Abstract

A sensor system that detects a current representative of a compound in a liquid mixture features a two-electrode strip adapted for releasable attachment to signal readout circuitry. The strip comprises an elongated support (preferably flat) adapted for releasable attachment to the readout circuitry; a first conductor and a second conductor each extend along the support and comprise means for connection to the circuitry. An active electrode, positioned to contact the liquid mixture and the first conductor, comprises a single layer deposit of an enzyme capable of catalyzing a reaction involving the compound, a conductive material and an electron mediator, capable of transferring electrons between the enzyme-catalyzed reaction and the first conductor. A reference electrode is positioned to contact the mixture and the second conductor. The system includes circuitry adapted to provide an electrical signal representative of the current. The two-electrode strip is manufactured, e.g., by screen printing an admixture of an enzyme, a conductive material, and a mediator as a single layer onto the substrate.

Claims

1. A single use disposable electrode strip for attachment to the signal readout circuitry of a sensor to detect a current representative of the concentration of a compound in a drop of a whole blood sample comprising:

a) an elongated support having a substantially flat, planar surface, adapted for releasable attachment to said readout circuitry;

b) a first conductor extending along said surface and comprising a conductive element for connection to said readout circuitry;

c) an active electrode on said strip in electrical contact with said first conductor and positioned to contact said whole blood sample;

d) a second conductor extending along said surface comprising a conductive element for connection to said read out circuitry; and

e) a reference counterelectrode in electrical contact with said second conductor and positioned to contact said whole blood sample,

wherein said active electrode is configured to be exposed to said whole blood sample without an intervening membrane or other whole blood filtering member and is formed by coating a portion of the first conductor with a mixture of or layers of an enzyme which catalyzes a redox reaction with said compound in whole blood and a mediator compound which transfers electrons from said redox reaction to said first conductor to create a current representative of the concentration of said compound in said whole blood sample; and

wherein said active electrode which is formed on a portion of said conductor is not in electrical contact with said reference counterelectrode but these electrodes are so dimensioned and positioned that they can be simultaneously completely covered by a single drop of whole blood such that this drop provides an electrical path between these electrodes to support said current representative of the concentration of said compound in said whole blood sample.

2. The electrode strip of claim 1 wherein the compound is glucose and the enzyme is glucose oxidase or glucose dehydrogenase.

3. The electrode strip of claim 1 wherein said conductive elements of the first and second conductors for connection to the read-out circuitry are positioned toward one end of said elongated support and said active electrode and reference counterelectrode are positioned remote from said end.

4. The electrode strip of claim 1 wherein said conductive elements of said first and second conductors are configured to allow releasable attachment with a socket on a read out meter which carries said signal readout circuitry.

5. The electrode strip of claim 1 wherein an area not covered by electrodes or conductors is at the end of said strip remote from the end carrying the conductive elements of the first and second conductors for connection to the read-out circuitry to facilitate handling of said strip.

6. The electrode strip of claim 1 wherein the enzyme and mediator are so proportioned to give a linear response at glucose concentrations ranging up to at least about 40 mM.

7. The electrode strip of claim 1 wherein the reference counterelectrode comprises a layer of Ag with a AgCl exposed surface.

8. The electrode strip of claim 1 wherein the mediator compound is selected from the group consisting of polyviologens, fluoranil, chloranil and metallocene compounds.

9. The electrode strip of claim 8 wherein the mediator compound is a ferrocene compound.