Electrochemical sensor for the determination of an analyte concentration

• US 8,828,200 B2
• Filed: 02/09/2009
• Issued: 09/09/2014
• Est. Priority Date: 08/08/2006
• Status: Active Grant

• Current Assignee: Roche Diabetes Care Inc. (Roche Holding AG)
• Original Assignee: Roche Diagnostics Operations Incorporated (Roche Holding AG)
• Inventors: Marquant, Michael, Bainczyk, Gregor
• Primary Examiner(s): Van, Luan
• Assistant Examiner(s): Kaur, Gurpreet
• Application Number:
  US12/367,725
• Publication Number:
  US 20090178923A1
• Time in Patent Office: 2,038 Days
• Field of Search: 20440301-40315, 205/777.5, 205/778, 205/792, 600345-348, 435 4- 4052
• US Class Current: 204/403.01
• CPC Class Codes: A61B 5/14532 for measuring glucose, e.g. by tissue impedance measurement
• 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: C25D 5/48 After-treatment of electroplated surfaces
• CPC Class Codes: G01N 27/301 Reference electrodes
• CPC Class Codes: G01N 27/327 Biochemical electrodes , e.g. electrical or mechanical details for in vitro measurements
• 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 27/4166 measuring a particular property of an electrolyte
• CPC Class Codes: G01N 33/4833 of solid biological material, e.g. tissue samples, cell cultures tissue in vivo A61B5/00; cell suspensions G01N33/48735
• CPC Class Codes: H01R 43/16 for manufacturing contact members, e.g. by punching and by bending
• CPC Class Codes: Y10T 29/49204 Contact or terminal manufacturing

Abstract

The invention relates to an electrochemical sensor for the determination of a concentration of at least one analyte in a medium, in particular a body tissue and/or a body fluid, to an apparatus that includes the electrochemical sensor, and to a use of the electrochemical sensor, and finally to a method for producing it. The electrochemical sensor has an isolation element and at least two electrodes. The at least two electrodes comprise at least one working electrode and at least one further electrode, in particular at least one counter electrode and/or at least one reference electrode. The at least two electrodes run parallel to one another and form an electrochemical measuring cell of the electrochemical sensor.

Claims

1. An electrochemical sensor for the determination of a concentration of at least one analyte in a body tissue or a body fluid, the electrochemical sensor having an isolation element and at least two electrodes, the at least two electrodes extending from an insertion end for insertion in the body tissue to an opposite second end, the at least two electrodes comprising a working electrode and at least one of a counter electrode and a reference electrode, wherein the at least two electrodes are at least partially formed as wire-shaped electrodes, the isolation element comprising a profiled shape and at least two holding compartments for the at least two electrodes, wherein the at least two electrodes extend along the isolation element in respective ones of the at least two holding compartments, and run substantially parallel to one another and have peripheral electrode surfaces along the at least two holding compartments that extend substantially from the insertion end to the opposite second end.

2. The electrochemical sensor as claimed in claim 1, wherein the isolation element comprises a cross-section having a design selected from the group consisting of Y-shaped, cross-shaped, and star-shaped.

3. The electrochemical sensor as claimed in claim 1, wherein the at least one working electrode is at least partly enveloped by a reagent medium configured for the determination of the concentration of the at least one analyte.

4. The electrochemical sensor as claimed in claim 1, wherein the at least two electrodes are enveloped at least partly by at least one layer of an immobilization medium, either individually or in the form of an electrode pack.

5. The electrochemical sensor as claimed in claim 4, wherein the immobilization medium is at least partly permeable to the at least one analyte.

6. The electrochemical sensor as claimed in claim 4, wherein the immobilization medium comprises a polymer material.

7. The electrochemical sensor as claimed in claim 1, wherein the isolation element comprises an electrically insulating polymer.

8. The electrochemical sensor as claimed claim 1, wherein the at least one working electrode comprises an electrode material that is suitable for an electron penetration reaction and for a current transport and includes at least one material from the group comprising gold, silver, palladium, platinum or carbon, and wherein the electrode material is at least partly enveloped by at least one reagent medium that has at least one material selected from the group consisting of an electro-redox catalyst for reducing the overvoltage, a mediator, an enzyme as a specific catalyst for the analyte to be detected, carbon, and a polymer binder material, and wherein the at least one reagent medium is surrounded at least partly by an immobilization medium.

9. The electrochemical sensor as claimed in claim 1, wherein at least one counter electrode is provided comprising a material selected from the group consisting of gold, silver, palladium, platinum or carbon.

10. The electrochemical sensor as claimed in claim 1, wherein at least one reference electrode is provided comprising Ag coated on its surface with AgCl, and being enveloped at least partly by an immobilization medium.

11. An apparatus for the determination of a concentration of at least one analyte in a body tissue or a body fluid, the apparatus comprising at least one electrochemical sensor as claimed in claim 1 and further comprising at least one measuring device configured for measuring one or both of a voltage and a current between the at least one working electrode and the at least one counter electrode or the at least one reference electrode, the apparatus further comprising an insertion head or an insertion aid.

12. The apparatus as claimed in claim 11, wherein the electrochemical sensor is connected to an electrical connection including a positive locking part.

13. The apparatus as claimed in claim 12, wherein the electrical connection comprises at least two electrical connections corresponding to the respective electrical contacts with the surfaces of the at least one working electrode and the at least one counter electrode or the at least one reference electrode.

14. The apparatus as claimed in claim 12, wherein the electrical connection comprises one of an insulation displacement connection, an insertion aid, and a hollow needle.

15. The apparatus as claimed in claim 1, wherein the peripheral electrode surfaces provide sensor surfaces that extend substantially along the at least two holding compartments from the insertion end to the second end.

16. The electrochemical sensor as claimed in claim 1, wherein the peripheral surface of the working electrode is coated with a reagent substantially from the insertion end to the second end.

17. An electrochemical sensor for the determination of a concentration of at least one analyte in a body tissue or a body fluid, the electrochemical sensor having an isolation element and at least two electrodes, the at least two electrodes comprising a working electrode and at least one of a counter electrode and a reference electrode, wherein the at least two electrodes are at least partially formed as wire-shaped electrodes, the isolation element comprising a profiled shape and at least two holding compartments for the at least two electrodes, wherein the at least two electrodes extend along the isolation element in respective ones of the at least two holding compartments, wherein the isolation element comprises a cross-section having a design selected from the group consisting of Y-shaped, cross-shaped, and star-shaped.