Mass transport limited in vivo analyte sensor

• US 6,975,893 B2
• Filed: 11/25/2003
• Issued: 12/13/2005
• 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: Audett, Jay D., Heller, Adam, Cho, Hyun, Tomasco, Michael F., Yamasaki, Duane O., Say, James L., Sakslund, Henning
• Primary Examiner(s): Nasser, Robert L.
• Assistant Examiner(s): MALLARI, PATRICIA C
• Application Number:
  US10/723,381
• Publication Number:
  US 20040111017A1
• Time in Patent Office: 749 Days
• Field of Search: 600/300, 600345-361, 600/365, 600/372.3, 600/73, 600/381, 600/316, 204/403.01, 20440306-40309, 204/403.1, 20440311-40314
• 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 body having a top layer impervious to glucose and a base layer impervious to glucose;

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

an analyte-responsive sensing layer comprising glucose oxidase and redox polymer proximate the working electrode; and

an open channel extending through the top layer to at least the working eletrode and the sensing layer, the sensing layer exposed for contact with glucose via the open channel, wherein a sensor signal is limited, at least in part, by mass transport of analyte to the sensing layer.

2. The electrochemical of claim 1, wherein the channel is defined by a small hole in the top layer.

3. The electrochemical of claim 1, wherein the channel extends through the top layer and through the base layer.

4. The electrochemical of claim 3, wherein the channel is defined by a first small hole in the top layer and a second small hole in the base layer.

5. The electrochemical of claim 4, wherein body is planar.

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

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 sensing layer further comprises a cross-linker.

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

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