Electrochemical-sensor design

• US 6,531,040 B2
• Filed: 12/08/2000
• Issued: 03/11/2003
• Est. Priority Date: 08/02/1999
• Status: Expired due to Term

• Current Assignee: Ascensia Diabetes Care Holdings AG (PHC Holdings Corporation)
• Original Assignee: Bayer Corporation (Bayer AG)
• Inventors: Edelbrock, Andrew J., Musho, Matthew K., Noell, J. Oakey
• Primary Examiner(s): Warden, Jill
• Assistant Examiner(s): NOGUEROLA, ALEXANDER STEPHAN
• Application Number:
  US09/731,943
• Publication Number:
  US 20010042683A1
• Time in Patent Office: 823 Days
• Field of Search: 204/403.01, 204/401, 204/403.06, 204/403.1, 204/403.11, 204/403.14, 204/409, 204/412, 204/411
• US Class Current: 204/401
• CPC Class Codes: C12Q 1/001 Enzyme electrodes
• CPC Class Codes: G01N 27/3274 Corrective measures, e.g. error detection, compensation for temperature or hematocrit, calibration coding of calibration information G01N33/48771

Abstract

Disclosed is an electrochemical sensor for detecting the concentration of an analyte such as glucose in a fluid test sample. The sensor involves a base as flow path for the fluid test sample having a working and counter electrode on its surface. The base is mated with a cover to form a capillary space to capture the fluid and the counter electrode has a sub-element located upstream in the flow path. When there is detected electrical communication only between the sub-element and the working electrode the meter, with which the sensor is in electrical communication senses that the capillary space has not completely filled with test fluid.

Claims

1. An electrochemical sensor for detecting the concentration of analyte in a fluid test sample which comprises:

1) a base which provides a flow path for the fluid test sample having on its surface a counter electrode and a working electrode in electrical communication with a detector of electrical current;

     2) a reaction layer on the surface of at least the working electrode comprising an enzyme which reacts with the analyte to produce electrons that are transferred to the working electrode; and

     3) a cover which when mated with the base member forms a capillary space with an opening for the introduction of fluid test sample thereto which space contains the flow path for the fluid test sample in which the counter and working electrodes are situated so that the major portion of the counter electrode is located downstream of the opening from the working electrode with a sub-element of the counter electrode being upstream of the working electrode so that when electrical communication between only the sub-element and working electrode takes place there is insufficient flow of electrical current through the detector to constitute a valid test for the concentration of analyte in the fluid test sample and the detector is pre-programmed to emit an error signal in the event of such insufficient flow of electrical current.

2. The sensor of claim 1 wherein the counter electrode and the sub-element are physically connected.

3. The sensor of claim 1 wherein the cover is made of a deformable material which is deformed to provide a concave area in the central portion thereof such that when the cover is mated with the base member the cover and the base member form the capillary space with the opening therein.

4. The sensor of claim 1 wherein the opening to the capillary space is solely through the cover or the base member.

5. The sensor of claim 4 wherein the opening is solely through the cover.

6. The sensor of claim 1 wherein the base and cover are configured to form the opening when they are mated.

7. The sensor of claim 6 wherein there is a U shaped member between the cover and the base, so that the opening is formed by mating the cover and base with the U shaped member therebetween.

8. The sensor of claim 6 wherein the cover is concave and the opening is formed by mating the based with the concave cover.

9. The sensor of claim 1 wherein the enzyme in the reaction layer is combined with a hydrophilic polymer.

10. The sensor of claim 1 wherein the enzyme is glucose oxidase.

11. The sensor of claim 1 wherein a major portion of the working electrode is covered by a dielectric material leaving a minor portion of it exposed to the test fluid and the major portion of the counter electrode is located downstream along the flow path, from the opening and downstream from the exposed portion of the working electrode.

12. The sensor of claim 1 wherein the sub-element of the counter electrode is not physically connected to the main element of the reference electrode and the sub-element is connected to the detector by its own connecting element.

13. The sensor of claim 1 wherein the reaction layer is also on the surface of the counter electrode.

14. A system for detecting the concentration of analyte in a fluid test sample which comprises the sensor of claim 1 in electrical connection with a meter which has been algorithmically programmed to measure the current between the electrodes at a definite time period after the fluid test sample has electrically connected the sub-element of the counter electrode with the working electrode and the ratio of the currents for two separate measurements is used to determine if the sensor has filled properly.