Electrochemical Analyte Sensor

• US 20140221801A1
• Filed: 04/11/2014
• Published: 08/07/2014
• Est. Priority Date: 03/04/1998
• Status: Abandoned Application

• Current Assignee: Abbott Diabetes Care Incorporated (Abbott Laboratories)
• Original Assignee: Abbott Diabetes Care Incorporated (Abbott Laboratories)
• Inventors: Say, James L., Tomasco, Michael Francis, Heller, Adam, Gal, Yoram, Aria, Behrad, Plante, Phillip John
• Application Number:
  US14/251,545
• Publication Number:
  US 20140221801A1
• Time in Patent Office: Days
• US Class Current: 600/347
• CPC Class Codes: A61B 5/01 Measuring temperature of body parts ; Diagnostic temperature sensing, e.g. for malignant or inflamed tissue clinical contact thermometers G01K13/20
• CPC Class Codes: A61B 5/14532 for measuring glucose, e.g. by tissue impedance measurement
• CPC Class Codes: A61B 5/14542 for measuring blood gases A61B5/14551 takes precedence
• CPC Class Codes: A61B 5/14546 for measuring analytes not otherwise provided for, e.g. ions, cytochromes
• CPC Class Codes: A61B 5/14735 comprising an immobilised reagent
• CPC Class Codes: A61B 5/1486 using enzyme electrodes, e.g. with immobilised oxidase
• 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: C12Q 1/001 Enzyme electrodes
• CPC Class Codes: C12Q 1/006 for glucose

Abstract

An electrochemical analyte sensor formed using conductive traces on a substrate can be used for determining and/or monitoring a level of analyte in in vitro or in vivo analyte-containing fluids. For example, an implantable sensor may be used for the continuous or automatic monitoring of a level of an analyte, such as glucose, lactate, or oxygen, in a patient. The electrochemical analyte sensor includes a substrate and conductive material disposed on the substrate, the conductive material forming a working electrode. In some sensors, the conductive material is disposed in recessed channels formed in a surface of the sensor. An electron transfer agent and/or catalyst may be provided to facilitate the electrolysis of the analyte or of a second compound whose level depends on the level of the analyte. A potential is formed between the working electrode and a reference electrode or counter/reference electrode and the resulting current is a function of the concentration of the analyte in the body fluid.

Claims

1. An in vivo glucose sensor, comprising:

a substrate for partial implantation through a skin surface, the substrate including at least a first surface and a second surface;

a first electrode disposed on the first surface of the substrate and configured to be positioned in fluid contact with interstitial fluid under the skin surface;

a second electrode disposed on the second surface of the substrate;

a plurality of conductive contacts disposed on the first surface of the substrate, wherein a first one of the plurality of conductive contacts is in electrical communication with the first electrode, and a second one of the plurality of conductive contacts is in electrical communication with the second electrode; and

at least one via formed through the substrate that electrically connects the second electrode to the second one of the plurality of conductive contacts;

wherein a flexibility of the sensor is varied along a continuum of the substrate.

2. The glucose sensor of claim 1, wherein the varied flexibility of the sensor is based at least in part on a composition of the substrate.

3. The glucose sensor of claim 1, wherein the varied flexibility of the sensor is based at least in part on a thickness of the substrate.

4. The glucose sensor of claim 1, wherein the varied flexibility of the sensor is based at least in part on a composition and a thickness of the substrate.

5. The glucose sensor of claim 1, further including a third electrode disposed on the first surface of the substrate and configured to be positioned in fluid contact with the interstitial fluid under the skin surface, and a third one of the plurality of conductive contacts is in electrical communication with the third electrode.

6. The glucose sensor of claim 1, wherein the first electrode is a working electrode comprising a glucose-responsive enzyme and a mediator, wherein at least one of the glucose-responsive enzyme and the mediator is chemically bonded to a polymer disposed on the working electrode, and wherein at least one of the glucose-responsive enzyme and the mediator is crosslinked with the polymer.

7. An in vivo glucose sensor, comprising:

a substrate for partial implantation through a skin surface, the substrate including at least a first surface and a second surface;

a first electrode disposed on the first surface of the substrate and configured to be positioned in fluid contact with interstitial fluid under the skin surface;

a second electrode disposed on the second surface of the substrate;

a plurality of conductive contacts disposed on the first surface of the substrate, wherein a first one of the plurality of conductive contacts is in electrical communication with the first electrode, and a second one of the plurality of conductive contacts is in electrical communication with the second electrode; and

at least one via formed through the substrate that electrically connects the second electrode to the second one of the plurality of conductive contacts;

wherein a length of the sensor is between 0.3 cm and 5 cm, and a flexibility of the sensor is varied along a continuum of the substrate.

8. The glucose sensor of claim 7, further comprising a subcutaneous portion, wherein a length of the subcutaneous portion is between 0.25 cm and 2 cm.

9. The glucose sensor of claim 7, further comprising a subcutaneous portion, wherein a length of the subcutaneous portion is 0.25 cm or less.

10. The glucose sensor of claim 7, wherein the varied flexibility of the sensor is based at least in part on a composition of the substrate.

11. The glucose sensor of claim 7, wherein the varied flexibility of the sensor is based at least in part on a thickness of the substrate.

12. The glucose sensor of claim 7, wherein the varied flexibility of the sensor is based at least in part on a composition and a thickness of the substrate.

13. The glucose sensor of claim 7, further including a third electrode disposed on the first surface of the substrate and configured to be positioned in fluid contact with the interstitial fluid under the skin surface, and a third one of the plurality of conductive contacts is in electrical communication with the third electrode.

14. The glucose sensor of claim 7, wherein the first electrode is a working electrode comprising a glucose-responsive enzyme and a mediator, wherein at least one of the glucose-responsive enzyme and the mediator is chemically bonded to a polymer disposed on the working electrode, and wherein at least one of the glucose-responsive enzyme and the mediator is crosslinked with the polymer.

15. An in vivo glucose sensor, comprising:

a substrate for partial implantation through a skin surface, the substrate including at least a first surface and a second surface;

a first electrode disposed on the first surface of the substrate;

a second electrode disposed on the second surface of the substrate;

a plurality of conductive contacts disposed on the first surface of the substrate, wherein a first one of the plurality of conductive contacts is in electrical communication with the first electrode, and a second one of the plurality of conductive contacts is in electrical communication with the second electrode; and

at least one via formed through the substrate that electrically connects the second electrode to the second one of the plurality of conductive contacts;

wherein a flexibility of the sensor is varied along a continuum of the substrate.

16. The glucose sensor of claim 15, wherein the substrate has a thickness of 100 μ

m to 300 μ

m.

17. The glucose sensor of claim 15, wherein the varied flexibility of the sensor is based at least in part on a composition of the substrate.

18. The glucose sensor of claim 15, wherein the varied flexibility of the sensor is based at least in part on a thickness of the substrate.

19. The glucose sensor of claim 15, wherein the varied flexibility of the sensor is based at least in part on a composition and a thickness of the substrate.

20. The glucose sensor of claim 15, further including a third electrode disposed on the first surface of the substrate and configured to be positioned in fluid contact with interstitial fluid under the skin surface, and a third one of the plurality of conductive contacts is in electrical communication with the third electrode.

21. The glucose sensor of claim 15, wherein the at least one via includes a plurality of vias formed through the substrate, each one of the plurality of vias electrically connecting the second electrode to the second one of the plurality of conductive contacts.

22. The glucose sensor of claim 15, wherein the first electrode is a working electrode comprising a glucose-responsive enzyme and a mediator, wherein at least one of the glucose-responsive enzyme and the mediator is chemically bonded to a polymer disposed on the working electrode, and wherein at least one of the glucose-responsive enzyme and the mediator is crosslinked with the polymer.