Tubular sensor for the detection of an analyte

• US 11,510,595 B2
• Filed: 11/03/2009
• Issued: 11/29/2022
• Est. Priority Date: 05/03/2007
• Status: Active Grant

• Current Assignee: Roche Diabetes Care Inc. (Roche Holding AG)
• Original Assignee: Roche Diabetes Care Inc. (Roche Holding AG)
• Inventors: Schwind, Karin, Haar, Hans-Peter, Fuerst, Otto
• Primary Examiner(s): Jang, Christian
• Assistant Examiner(s): Toth, Karen E
• Application Number:
  US12/611,579
• Publication Number:
  US 20100113907A1
• Time in Patent Office: 4,774 Days
• Field of Search: 600309, 600345, 600347, 600365, 600372, 607116-122
• CPC Class Codes: A61B 5/14532 for measuring glucose, e.g. by tissue impedance measurement
• CPC Class Codes: A61B 5/14546 for measuring analytes not otherwise provided for, e.g. ions, cytochromes
• 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: A61B 5/6849 in combination with a needle set

Abstract

An implantable sensor can be used for determining a concentration of at least one analyte in a medium, particularly in a body tissue and/or a body fluid. The implantable sensor can comprise a flexible, tubular sensor element. This sensor element has a tubular body on which at least two electrode rings are mounted for electrochemical determination of the concentration of the analyte.

Claims

1. An implantable sensor for determining a concentration of at least one analyte in a medium, the implantable sensor comprising a flexible, tubular sensor element, the tubular sensor element defining a longitudinal sensor axis, and the tubular sensor element comprising a flexible, tubular body and a plurality of electrode groups wherein each electrode group includes at least two electrode rings adapted for electrochemical determination of the concentration of the analyte;

and wherein each of the electrode rings of each electrode group is mounted on the tubular body and is longitudinally spaced apart from each of the other electrode rings mounted on the tubular body, and wherein electrically and/or galvanically insulated supply lines each having an embedded length that extends from proximate an end of the tubular body opposite from an implantation end to a respective one of the electrode rings are embedded in the tubular body such that the embedded length of the supply lines are circumferentially spaced apart from each other within the tubular body and the embedded length of each of the supply lines extends parallel to the longitudinal sensor axis and wherein each of the electrode rings mounted on the tubular body is coupled to a separate supply line and wherein each of the electrode groups includes at least one working electrode and at least one further electrode selected from a counterelectrode and/or a reference electrode positioned on the tubular body in a longitudinally sequential pattern of electrode rings, with each of the electrode groups having the same longitudinally sequential pattern of electrode rings and wherein the implantable sensor produces a signal indicative of analyte concentration when implanted and wherein the plurality of electrode groups are arranged sequentially along the longitudinal sensor axis such that the at least two electrode rings forming each one of the electrode groups are positioned along a continuous longitudinal length of the tubular body which is non-overlapping and separate from the longitudinal length of the tubular body on which the electrode rings of the other electrode groups are positioned; and

wherein when an actuation and evaluation unit actuates one of the plurality of electrode groups to obtain a signal indicative of an analyte concentration, the actuation and evaluation unit additionally subjects to an electrical potential the electrode groups which are longitudinally adjacent to the one electrode group being used to obtain the signal indicative of an analyte concentration to shield the electrode group being used to obtain the signal indicative of the analyte concentration.

2. The implantable sensor of claim 1 wherein the electrode rings are electrically connected to the supply lines by electrically plated through-holes that extend at least partially through the tubular body.

3. The implantable sensor of claim 1 wherein electrical contacts for the contacting of the electrode rings are provided at an end of the sensor element directed away from the implantation end.

4. The implantable sensor of claim 1 wherein the electrode rings, on a side directed away from the tubular body, are at least partially surrounded by at least one membrane layer, and wherein the at least one membrane layer is at least partially permeable to the at least one analyte.

5. The implantable sensor of claim 1 wherein the embedded length of the supply lines extend to the implantation end of the tubular body whereby the tubular body does not fully cover the supply lines at the implantation end of the tubular body and wherein the implantation end of the tubular body is coated by an electrical insulation material which electrically insulates the individual supply lines from one another and from the body tissue at the implantation end of the tubular body.

6. The implantable sensor of claim 1 further comprising an implantation needle which is mounted slidably in the tubular body in such a way that the implantation needle, after implantation of the implantable sensor in the medium, can be at least partially withdrawn from the tubular body.

7. The implantable sensor of claim 6 wherein the implantation needle is an acupuncture needle having a diameter of between 0.40 mm and 0.7 mm.

8. The implantable sensor of claim 6 wherein the implantation needle is a needle with a tip which is made at least partially of a biocompatible, enzymatically degradable material, such that the tip becomes at least partially rounded after implantation in the medium.

9. A sensor system for determining a concentration of at least one analyte in a medium, the sensor system comprising at least one of the implantable sensors of claim 1, and further comprising an actuation and evaluation unit which is connected to the electrode rings and which is configured to carry out an electrochemical measurement in order to determine the concentration of the analyte.

10. The implantable sensor of claim 1 wherein six to fifteen supply lines are embedded within the tubular body and are each respectively connected to a separate electrode ring disposed on the tubular body.

11. A method for producing an implantable sensor adapted for determining a concentration of at least one analyte in a medium, comprising:

producing a tubular body for a tubular sensor element wherein the tubular sensor element defines a longitudinal sensor axis;

applying to the tubular body a plurality of electrode groups, each electrode group having at least two electrode rings at longitudinally spaced apart locations, the at least two electrode rings of each electrode group being adapted for electrochemical determination of the concentration of the analyte wherein the at least two electrode rings of each electrode group comprise at least one working electrode and at least one further electrode selected from a counterelectrode and/or a reference electrode and wherein the electrode rings forming the plurality of electrode groups are arranged such that the at least one working electrode and the at least one further electrode of each electrode group defines a longitudinally sequential pattern of electrode rings with each of the electrode groups defining the same longitudinal sequential pattern of electrode rings and wherein the at least two electrode rings forming each one of the electrode groups are positioned along a continuous longitudinal length of the tubular body which is non-overlapping and separate from the longitudinal length of the tubular body on which the electrode rings of the other electrode groups are positioned; and

embedding electrically and/or galvanically insulated supply lines for the at least two electrode rings of each electrode group in the tubular body such that the supply lines have an embedded length that extends parallel to the longitudinal sensor axis and from proximate an end of the tubular element opposite from an implantation end to a respective one of the electrode rings and wherein the supply lines are circumferentially spaced apart from each other within the tubular body, and connecting each of the electrode rings to a separate supply line wherein each of the electrode groups independently produces a signal indicative of analyte concentration when implanted; and

providing an actuation and evaluation unit to actuate one of the plurality of electrode groups to obtain a signal indicative of an analyte concentration, the actuation and evaluation unit additionally configured to subject to an electrical potential the electrode groups which are longitudinally adjacent to the one electrode group being used to obtain the signal indicative of an analyte concentration to shield the electrode group being used to obtain the signal indicative of the analyte concentration.

12. The method of claim 11 wherein the embedding takes place in one method step with the production of the tubular body.

13. The method of claim 11 wherein a plated through-hole is produced in order to connect the electrode rings electrically to the supply lines.

14. The method of claim 13 wherein the plated through-hole is produced by creating a via through at least one material layer between the electrode rings and the supply lines, and wherein the via is then at least partially filled with at least one electrically conductive material.

15. The method of claim 11 wherein, in order to produce the electrode rings, in each case at least one electrically conductive contact ring directed toward the tubular body is first created, and then in each case at least one function layer is applied to the contact ring.

16. The method of claim 15 wherein the contact rings and/or the function layers are applied using in each case at least one of the following methods for structured application of a layer:

a laminating method, a spray-on method, an inkjet method, a contact printing method, an offset method, or an electrostatic printing method.

17. The method of claim 15 wherein the application of the contact rings and/or of the function layers involves at least one contact ring and/or at least one function layer being applied to a flexible carrier substrate, and the flexible carrier substrate then being applied to the tubular body.

18. The method of claim 11, further comprising:

surrounding at least partially the electrode rings, on the side directed away from the tubular body, with at least one membrane layer, wherein the at least one membrane layer is at least partially permeable to the at least one analyte.

19. The method of claim 11 wherein between 6 and 15 supply lines are embedded within the tubular body and are each respectively connected to a separate electrode ring disposed on the tubular body.

20. The method of claim 11 wherein the embedded length of the supply lines extend to the implantation end of the tubular body and, wherein after the step of embedding the supply lines, the supply lines are exposed at the implantation end of the tubular body and the method further comprises:

electrically insulating the individual supply lines from one another and from the body tissue at the implantation end of the tubular body by coating the implantation end of the tubular body with an electrical insulation material.

21. The method of claim 11, further comprising:

introducing an implantation needle into the tubular body.

22. The method of claim 11 wherein the embedded length of the supply lines extend to the implantation end of the tubular body and, after the step of embedding the supply lines, the supply lines are exposed at the implantation end of the tubular body and wherein the method further comprises coating the implantation end of the tubular body to thereby electrically insulate the exposed supply lines from one another and from the body tissue at the implantation end of the tubular body.

23. An implantable sensor for determining a concentration of at least one analyte in a medium, the implantable sensor comprising a flexible, tubular sensor element, the tubular sensor element defining a longitudinal sensor axis, and the tubular sensor element comprising a flexible, tubular body wherein a plurality of electrode groups are disposed on the tubular body, each electrode group including at least two electrode rings adapted for electrochemical determination of the concentration of the analyte are mounted on the tubular body, the at least two electrode rings of each electrode group being longitudinally spaced apart, said electrode rings of each electrode group comprising at least one working electrode and at least one further electrode selected from a counter electrode and/or a reference electrode, wherein electrically and/or galvanically insulated supply lines for the at least two electrode rings of each electrode group are embedded in the tubular body, and wherein the supply lines have an embedded length that extends parallel to the longitudinal axis and from proximate an end of the sensor element opposite from an implantation end to a respective one of the electrode rings and wherein the supply lines are circumferentially spaced apart from each other within the tubular body, wherein each electrode group of the implantable sensor independently produces a signal indicative of analyte concentration when implanted and wherein the electrode rings forming the plurality of electrode groups are arranged such that the at least one working electrode and the at least one further electrode of each electrode group defines a longitudinally sequential pattern of electrode rings with each of the electrode groups defining the same longitudinal sequential pattern of electrode rings and wherein the at least two electrode rings forming each one of the electrode groups are positioned along a continuous longitudinal length of the tubular body which is non-overlapping and separate from the longitudinal length of the tubular body on which the electrode rings of the other electrode groups are positioned;

and

an actuation and evaluation unit operably connected with the implantable sensor wherein the actuation and evaluation unit actuates and evaluates the plurality of electrode groups independently of each other;

wherein when the actuation and evaluation unit actuates one of the plurality of electrode groups to obtain a signal indicative of an analyte concentration, the actuation and evaluation unit additionally subjects to an electrical potential the electrode groups which are longitudinally adjacent to the one electrode group being used to obtain the signal indicative of the analyte concentration to shield the electrode group being used to obtain the signal indicative of the analyte concentration.

24. The implantable sensor of claim 23 wherein each electrode group includes three electrode rings comprising a working electrode, a counter electrode and a reference electrode.

25. The implantable sensor of claim 23 wherein, when the actuation and evaluation unit actuates one of the plurality of electrode groups to obtain a signal indicative of an analyte concentration, the actuation and evaluation unit subjects to an electrical potential the electrode rings which are longitudinally adjacent to the one electrode group being used to obtain the signal indicative of an analyte concentration.

26. The implantable sensor of claim 25 wherein six to fifteen supply lines are embedded within the tubular body and are each respectively connected to a separate electrode ring disposed on the tubular body and wherein the embedded length of the supply lines extend to the implantation end of the tubular body whereby the tubular body does not fully cover the supply lines at the implantation end of the tubular body and wherein the implantation end of the tubular body is coated by an electrical insulation material which electrically insulates the individual supply lines from one another and from the body tissue at the implantation end of the tubular body.

27. The implantable sensor of claim 25 wherein each of the electrode rings extend about a complete circumference of the tubular body.