Mass transport limited in vivo analyte sensor

• US 6,654,625 B1
• Filed: 06/16/2000
• Issued: 11/25/2003
• Est. Priority Date: 06/18/1999
• Status: Expired due to Term

• Current Assignee: Abbott Diabetes Care Incorporated (Abbott Laboratories Incorporated)
• Original Assignee: Therasense Incorporated (Abbott Laboratories Incorporated)
• Inventors: Cho, Hyun, Tomasco, Michael F., Yamasaki, Duane O., Sakslund, Henning, Audett, Jay D., Heller, Adam, Say, James L.
• Primary Examiner(s): Nasser, Robert L.
• Assistant Examiner(s): MALLARI, PATRICIA C
• Application Number:
  US09/595,708
• Time in Patent Office: 1,257 Days
• Field of Search: 600/345, 600/347, 600/348, 600/365, 204/403, 204/403.01, 204/403-4-4, 204/403-9-4
• US Class Current: 600/347
• 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 1/002 Electrode membranes
• CPC Class Codes: C12Q 1/006 for glucose
• CPC Class Codes: Y10S 977/925 Bioelectrical

Abstract

An in vivo electrochemical sensor including a working electrode, and an analyte-responsive sensing layer proximate the working electrode. The sensing layer is exposed at an edge of the sensor, wherein the sensor signal is limited, at least in part, by mass transport of analyte to the sensing layer. The sensor is configured and arranged for implantation into the body of a mammal for contact with body fluids of the mammal. The analyte diffuses to the sensing element via the edge of the sensor, thereby restricting mass transport of the analyte to the sensing element. This is because the solution-contacting surface area of the sensor edge is much smaller than an open face of the sensing layer.

Claims

1. An electrochemical sensor for subcutaneous glucose sensing, the sensor comprising:

a planar body having a top layer permeable to oxygen and impervious to glucose, a base layer impervious to glucose, and a peripheral edge;

a working electrode disposed between the top layer and the base layer; and

an analyte-responsive sensing layer proximate the working electrode, the sensing layer at least partially disposed between the working electrode and the top layer and extending to the peripheral edge of the sensor, so that contact with the glucose occurs only at the peripheral edge of the sensor, the sensing layer comprising glucose oxidase and a redox polymer.

2. The electrochemical sensor of claim 1, wherein the sensing layer further comprises a cross-linker.

3. The electrochemical sensor of claim 1, wherein the peripheral edge is a distal edge of the sensor.

4. The electrochemical sensor of claim 1, wherein the peripheral edge is a side edge of the sensor.

5. The electrochemical sensor of claim 1, wherein the sensor defines a channel having an inner peripheral surface extending into the sensor, and wherein the peripheral edge at which the sensing layer is exposed is defined by at least a portion of the inner peripheral surface of the channel.

6. The electrochemical sensor of claim 1, wherein the sensing layer is less than 100 μ

m thick.

7. The electrochemical sensor of claim 6, wherein the sensing layer is in the range of 1 to 10 μ

m thick.

8. The electrochemical sensor of claim 1, wherein the sensor body is flexible.

9. The electrochemical sensor of claim 1, wherein the sensing layer is non-leachably disposed on the sensor.

10. The electrochemical sensor of claim 1, wherein the sensor further includes a spacer layer at least partially disposed between the base layer and the top layer, the spacer layer defining a channel having an inner peripheral surface extending into the spacer layer, and wherein the peripheral edge at which the sensing layer is exposed is defined by at least a portion of the inner peripheral surface of the channel.

11. A method of determining the concentration of glucose in a body fluid of a mammal, the method comprising:

providing an electrochemical sensor comprising a planar body, a top layer permeable to oxygen and impervious to glucose, a base layer impervious to glucose, a working electrode between the top layer and the base layer, and an analyte-responsive sensing layer comprising glucose oxidase and redox polyer proximate the working electrode and between the working electrode and the top layer, the sensing layer exposed for contact with analyte only at a peripheral edge of the sensor;

implanting at least a portion of the sensor into the body of the mammal such that the edge of the sensor contacts body fluid of the mammal; and

measuring the concentration of the glucose in body fluid of the mammal using the sensor.

12. The method of claim 11, wherein the peripheral edge is a distal edge of the sensor.

13. The method of claim 11, wherein the peripheral edge is a side edge of the sensor.

14. The method of claim 11, wherein the sensor defines a channel having an inner peripheral surface extending into the sensor, and wherein the peripheral edge at which the sensing layer is exposed is defined by at least a portion of the inner peripheral surface of the channel.

15. The method of claim 11, wherein the sensor further includes a spacer layer at least partially disposed between the base layer and the top layer, the spacer layer defining a channel having in inner peripheral surface extending into the spacer layer, and wherein the peripheral edge at which the sensing layer is exposed is defined by at least a portion of the inner peripheral surface of the channel.

16. The method of claim 11, wherein the sensor is subcutaneously implanted.

17. The method of claim 16, wherein the sensor is used to measure an analyte in subcutaneous fluid.

18. An electrochemical sensor for subcutaneous glucose sensing, the sensor comprising:

a planar body having a top layer permeable to oxygen and impervious to glucose, and a base layer impervious to glucose;

a working electrode disposed between the top layer and the base layer; and

an analyte-responsive sensing layer comprising glucose oxidase and a redox polymer proximate the working electrode between the top layer and the working electrode,

wherein the sensor defines a channel having therein an inner peripheral surface extending into the sensor, and wherein the sensing layer is exposed for contact with analyte only at a portion of the inner peripheral surface of the channel.

19. An electrochemical sensor for subcutaneous glucose sensing, the sensor comprising:

a planar sensor body having an outer portion impervious to glucose and at least a part of which is permeable to oxygen, and a peripheral edge;

a working electrode disposed within the sensor body; and

an analyte-responsive sensing layer comprising glucose oxidase and redox polymer disposed at least partially between the outer portion and the working electrode and extending to the peripheral edge of the sensor for contact with glucose only at the edge of the sensor.

20. The electrochemical sensor of claim 19, wherein the exposed portion of the sensing layer is less than 100 μ

m thick.

21. The electrochemical sensor of claim 20, wherein the exposed portion of the sensing layer is in the range of 1 to 10 μ

m thick.

22. The electrochemical sensor of claim 19, wherein the sensor body further includes a spacer layer at least partially disposed between the base layer and the top layer, the spacer layer defining a channel having in inner peripheral surface extending into the spacer layer, and wherein the peripheral edge at which the sensing layer is exposed is defined by at least a portion of the inner peripheral surface of the channel.

23. The electrochemical sensor of claim 19, wherein the peripheral edge is a distal edge of the sensor body.

24. The electrochemical sensor of claim 19, wherein the peripheral edge is a side edge of the sensor body.

25. The electrochemical sensor of claim 19, wherein the sensor body defines a channel having an inner peripheral surface extending into the sensor body, and wherein the peripheral edge at which the sensing layer is exposed is defined by at least a portion of the inner peripheral surface of the channel.