Electrochemical biosensor

• US 9,377,430 B2
• Filed: 03/25/2014
• Issued: 06/28/2016
• Est. Priority Date: 02/06/2004
• Status: Active Grant

• Current Assignee: Ascensia Diabetes Care Holdings AG (PHC Holdings Corporation)
• Original Assignee: Ascensia Diabetes Care Holdings AG (PHC Holdings Corporation)
• Inventors: Huang, Dijia, Charlton, Steven C., George, Suny J., Edelbrock, Andrew J.
• Primary Examiner(s): Dieterle, Jennifer
• Application Number:
  US14/224,899
• Publication Number:
  US 20140202881A1
• Time in Patent Office: 826 Days
• US Class Current: 1/1
• CPC Class Codes: C12Q 1/006 for glucose
• CPC Class Codes: G01N 27/3272 Test elements therefor, i.e. disposable laminated substrates with electrodes, reagent and channels optical biosensors G01N33/52
• CPC Class Codes: G01N 27/3274 Corrective measures, e.g. error detection, compensation for temperature or hematocrit, calibration coding of calibration information G01N33/48771
• CPC Class Codes: G01N 27/3275 Sensing specific biomolecules, e.g. nucleic acid strands, based on an electrode surface reaction
• CPC Class Codes: G01N 27/4163 checking the operation of, or calibrating, the measuring apparatus G01N27/3274, G01N27/4175 and G01N33/0006 take precedence
• CPC Class Codes: Y10T 29/49082 Resistor making
• CPC Class Codes: Y10T 29/49099 Coating resistive material on a base

Abstract

According to one embodiment of the present invention, an electrochemical sensor (10) for detecting the concentration of analyte in a fluid test sample is disclosed. The sensor (10) includes a counter electrode having a high-resistance portion for use in detecting whether a predetermined amount of sample has been received by the test sensor.

Claims

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

a flow path for receiving the fluid test sample;

a plurality of leads each configured to be electrically coupled with a detector of electrical current;

a working electrode disposed along the flow path and in electrical communication with at least one of the plurality of leads;

a counter electrode disposed along the flow path and in electrical communication with at least one of the plurality of leads, the counter electrode including a high-resistance portion located upstream along the flow path relative to the working electrode and a low-resistance portion located downstream along the flow path relative to the working electrode;

a resistor in electrical communication with at least one of the plurality of leads and the high-resistance portion, wherein the high-resistance portion and the resistor is electrically bypassed when the fluid test sample fills the flow path between the working electrode and the low-resistance portion; and

a reagent disposed on at least the working electrode, the reagent being configured to react with the analyte to produce electrons that are transferred to the working electrode.

2. The electrochemical sensor of claim 1, wherein the reagent is further disposed over low-resistance portion of the counter electrode.

3. The electrochemical sensor of claim 2, wherein the reagent is also further disposed over the high-resistance portion of the counter electrode.

4. The electrochemical test sensor of claim 1, wherein the flow path is a capillary space formed by a lid mated to a base, the capillary space having an opening configured to receive the fluid test sample.

5. The electrochemical test sensor of claim 4, wherein the lid includes a concave portion to assist in forming the capillary space.

6. The electrochemical sensor of claim 1, wherein the working electrode, the counter electrode, and the resistor are formed by the same type of manufacturing process.

7. The electrochemical sensor of claim 6, wherein the type of manufacturing process is a screen printing process.

8. The electrochemical sensor of claim 1, wherein the reagent and the resistor are formed by the same type of manufacturing process.

9. The electrochemical sensor of claim 8, wherein the type of manufacturing process is a screen printing process.

10. The electrochemical sensor of claim 1, wherein the resistor is electrically coupled to at least one of the plurality of leads on the base.

11. A method of manufacturing an electrochemical sensor for determining a concentration of an analyte in a fluid test sample, comprising:

providing a base;

forming a plurality of leads on the base;

forming a working electrode on the base and electrically coupled to at least one of the plurality of leads;

forming a counter electrode on the base and electrically coupled to at least one of the plurality of leads, the counter electrode including a high-resistance portion located upstream along the flow path relative to the working electrode and a low-resistance portion located downstream along the flow path relative to the working electrode;

forming a resistor on the base and electrically coupled to at least one of the plurality of leads and the high-resistance portion, wherein the high-resistance portion and the resistor is bypassed when the fluid test sample fills the flow path between the working electrode and the low-resistance portion;

forming a reaction layer disposed over at least the working electrode, the reaction layer including a reagent that is configured to react with an analyte in a fluid test sample for producing an electrochemical reaction indicative of the concentration of the analyte in the fluid test sample; and

coupling a lid to the base to form a capillary space having an opening configured to receive a fluid sample, the working electrode and the counter electrode being exposed within the capillary space.

12. The method of claim 11, wherein the resistor is not exposed within the capillary space.

13. The method of claim 11, wherein the lid includes a concave space to assist in defining the capillary space.

14. The method of claim 11, wherein the reagent is further disposed over the counter electrode.

15. The method of claim 11, wherein the resistor forms a portion of the counter electrode.

16. The method of claim 11, further comprising forming a dielectric layer over the resistor, the dielectric layer having an opening through which the working electrode and the counter electrode are exposed within the capillary space.

17. The method of claim 11, wherein the working electrode and the resistor are formed on the base by the same type of manufacturing process.

18. The method of claim 17, wherein the working electrode and the resistor are screen-printed on the base.

19. The method of claim 11, wherein the reagent and the resistor are formed on the base by the same type of manufacturing process.

20. The method of claim 19, wherein the reagent and the resistor are screen-printed on the base.