Electrochemical sensor for determining an analyte concentration

• US 10,060,877 B2
• Filed: 02/02/2016
• Issued: 08/28/2018
• Est. Priority Date: 08/08/2006
• Status: Active Grant

• Current Assignee: Roche Diabetes Care Inc. (Roche Holding AG)
• Original Assignee: Roche Diabetes Care Inc. (Roche Holding AG)
• Inventors: Bainczyk, Gregor, Marquant, Michael
• Primary Examiner(s): Kaur, Gurpreet
• Application Number:
  US15/013,094
• Publication Number:
  US 20160153933A1
• Time in Patent Office: 938 Days
• 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 continuous 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 at least one of the electrodes is at least partially formed as a wire-shaped electrode having a circumferential electrode surface configured to be exposed to the body tissue or the body fluid and wherein the sensor is configured to be implanted in the body tissue and/or subcutaneously inserted and wherein the sensor further comprises a membrane layer covering the at least two electrodes wherein the membrane layer is biocompatible and at least partially permeable to the at least one analyte;

and

wherein the isolation element comprises a cross-section having a design selected from the group consisting of Y-shaped, cross-shaped, and star-shaped.

2. The electrochemical sensor of claim 1 wherein the isolation element comprises a profiled shape and has 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.

3. The electrochemical sensor of claim 1 wherein the electrodes are at least partially embedded in an isolation material.

4. The electrochemical sensor of claim 3 wherein the electrodes are completely embedded in an isolation material.

5. The electrochemical sensor of claim 3 wherein the isolation material is an electrically non-conducting material.

6. The electrochemical sensor of claim 5 wherein the isolation material is plastic.

7. The electrochemical sensor of claim 1 wherein the electrodes are aligned with one another at least in one section in a parallel arrangement.

8. The electrochemical sensor of claim 7 wherein the electrodes are arranged along their lengths in a parallel arrangement.

9. The electrochemical sensor of claim 1 wherein the sensor comprises an Ag/AgCl reference/counter electrode.

10. The electrochemical sensor of claim 1 wherein the membrane layer comprises a polyurethane membrane layer.

11. The electrochemical sensor of 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.

12. The electrochemical sensor of 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.

13. The electrochemical sensor of claim 12 wherein the immobilization medium is at least partly permeable to the at least one analyte.

14. The electrochemical sensor of claim 12 wherein the immobilization medium comprises a polymer material.

15. The electrochemical sensor of claim 1 wherein the isolation element comprises an electrically insulating polymer.

16. The electrochemical sensor of 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.

17. The electrochemical sensor of claim 1 wherein at least one counter electrode is provided and comprises a material selected from the group consisting of gold, silver, palladium, platinum or carbon.

18. The electrochemical sensor of claim 1 wherein at least one reference electrode is provided and comprises Ag coated on its surface with AgCl and is enveloped at least partly by an immobilization medium.

19. 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.

20. The apparatus of claim 19 wherein the electrochemical sensor is connected to an electrical connection including a positive locking part.

21. The apparatus of claim 20 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.

22. The apparatus of claim 20 wherein the electrical connection comprises one of an insulation displacement connection, an insertion aid, and a hollow needle.

23. The electrochemical sensor of claim 1 further comprising an insulating polymer providing a barrier layer for the at least two electrodes.

24. The electrochemical sensor of claim 23 wherein the insulating polymer is selected from the group consisting of polyester, polyethylene, polypropylene and polyurethane.

25. An electrochemical sensor for the continuous 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 at least one of the electrodes is at least partially formed as a wire-shaped electrode having a circumferential electrode surface configured to be exposed to the body tissue or the body fluid and wherein the sensor is configured to be implanted in the body tissue and/or subcutaneously inserted and wherein the sensor further comprises a membrane layer covering the at least two electrodes wherein the membrane layer is biocompatible and at least partially permeable to the at least one analyte;

and

wherein the membrane layer coats the entire circumference of the circumferential electrode surface of each of the at least two electrodes.

26. An electrochemical sensor for the continuous 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 at least one of the electrodes is at least partially formed as a wire-shaped electrode having a circumferential electrode surface configured to be exposed to the body tissue or the body fluid and wherein the sensor is configured to be implanted in the body tissue and/or subcutaneously inserted and wherein the sensor further comprises a membrane layer covering the at least two electrodes wherein the membrane layer is biocompatible and at least partially permeable to the at least one analyte;

and

wherein the isolation element and the at least two electrodes are all elongate elements which extend together in parallel with the at least two electrodes being disposed on opposing sides of the isolation element whereby the isolation element is disposed between the at least two electrodes to thereby define an elongate electrode pack wherein each of the at least two electrodes of the electrode pack has an elongate circumferential surface configured to be exposed to the body tissue or the body fluid.

27. The electrochemical sensor of claim 26 wherein the membrane forms a coating enveloping the at least two electrodes of the elongate electrode pack.

28. The electrochemical sensor of claim 27 further comprising an insulating polymer providing a barrier layer for the elongate electrode pack wherein the insulating polymer is selected from the group consisting of polyester, polyethylene, polypropylene and polyurethane.

29. An electrochemical sensor for the continuous 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 at least one of the electrodes is at least partially formed as a wire-shaped electrode having a circumferential electrode surface configured to be exposed to the body tissue or the body fluid and wherein the sensor is configured to be implanted in the body tissue and/or subcutaneously inserted and wherein the sensor further comprises a membrane layer covering the at least two electrodes wherein the membrane layer is biocompatible and at least partially permeable to the at least one analyte;

and

wherein the at least two electrodes are three elongate electrodes and the isolation element is an elongate element defining a Y-shaped cross section having three webs wherein the three elongate electrodes and the isolation element extend together in parallel with each of the webs of the isolation element being disposed between two of the elongate electrodes to thereby define an elongate electrode pack wherein each of the three electrodes of the electrode pack has an elongate circumferential surface configured to be exposed to the body tissue or the body fluid.

30. The electrochemical sensor of claim 29 wherein the membrane forms a coating enveloping three elongate electrodes of the elongate electrode pack.

31. The electrochemical sensor of claim 30 further comprising an insulating polymer providing a barrier layer for the elongate electrode pack wherein the insulating polymer is selected from the group consisting of polyester, polyethylene, polypropylene and polyurethane.