Analyte sensing biointerface

• US 20060257996A1
• Filed: 04/14/2006
• Published: 11/16/2006
• Est. Priority Date: 04/15/2005
• Status: Active Grant

• Current Assignee: DexCom Incorporated
• Original Assignee: DexCom Incorporated
• Inventors: Brauker, James H., Simpson, Peter C.
• Granted Patent: US 8,060,174 B2
• Time in Patent Office: Days
• US Class Current: 435/287.200
• CPC Class Codes: A61B 5/0031 Implanted circuitry
• CPC Class Codes: A61B 5/14532 for measuring glucose, e.g. by tissue impedance measurement
• 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: B33Y 80/00 Products made by additive manufacturing
• CPC Class Codes: C12Q 1/001 Enzyme electrodes
• CPC Class Codes: C12Q 1/006 for glucose

Abstract

Disclosed herein is an analyte sensing biointerface that comprises a sensing electrode incorporated within a non-conductive matrix comprising a plurality of passageways extending through the matrix to the sensing electrode. Also disclosed herein are methods of manufacturing a sensing biointerface and methods of detecting an analyte within tissue of a host using an analyte sensing biointerface.

Claims

1. An implantable analyte sensor, comprising:

an electrically non-conductive biocompatible matrix comprising a plurality of passageways extending from openings in an exterior surface of the matrix into an interior portion of the matrix;

a working electrode comprising an electrically conductive material, wherein an electroactive surface of the working electrode is within the matrix; and

electronics electrically coupled to the working electrode, the electronics configured to detect a current flowing through the working electrode or a voltage of the working electrode, wherein the current or voltage is indicative of a quantity of an analyte within the passageways.

2. The sensor of claim 1, comprising a membrane coating surfaces of at least some of the passageways in the interior portion of the matrix, the membrane comprising a component that affects a rate of diffusion of the analyte through the membrane.

3. The sensor of claim 1, comprising a membrane coating surfaces of at least some of the passageways in the interior portion of the matrix, the membrane comprising a component that is capable of reacting with the analyte to produce a species that is capable of electrochemically reacting at a surface of the working electrode.

4. The sensor of claim 1, comprising a reference electrode disposed within the matrix, wherein an electroactive surface of the reference electrode is within the matrix, and wherein at least a portion of the matrix electrically insulates the reference electrode from the working electrode.

5. The sensor of claim 1, comprising a reference electrode disposed on an exterior surface of the matrix, wherein at least a portion of the matrix electrically insulates the reference electrode from the working electrode.

6. The sensor of claim 1, comprising a counter electrode disposed within the matrix, wherein an electroactive surface of the counter electrode is within the matrix, and wherein at least a portion of the matrix electrically insulates the counter electrode from the working electrode.

7. The sensor of claim 1, comprising a counter electrode disposed on an exterior surface of the matrix, wherein at least a portion of the matrix electrically insulates the counter electrode from the working electrode.

8. The sensor of claim 1, wherein the matrix is a substantially solid material and the passageways comprise pores within the substantially solid material.

9. The sensor of claim 8, wherein the pores have a size of between about 20 microns and about 1000 microns in at least one dimension.

10. The sensor of claim 1, wherein the matrix is a mesh of fibers.

11. The sensor of claim 10, wherein the fibers have a size of between about 1 micron and about 100 microns in at least one dimension.

12. The sensor of claim 10, wherein the mesh of fibers comprise woven fibers.

13. The sensor of claim 10, wherein the mesh of fibers comprise non-woven fibers.

14. The sensor of claim 10, wherein the fibers comprise an electrically non-conductive material.

15. The sensor of claim 10, wherein the fibers comprise an electrically conductive material.

16. The sensor of claim 10, further comprising a membrane coating the fibers.

17. The sensor of claim 1, wherein the working electrode has a membrane coating disposed thereon.

18. The sensor of claim 1, comprising a bioactive agent in the electrically non-conductive biocompatible matrix or in one or more of the passageways.

19. An implantable analyte sensor, comprising:

a biocompatible matrix comprising a plurality of passageways extending from openings in an exterior surface of the matrix into an interior portion of the matrix; and

a sensing mechanism incorporated into the biocompatible matrix in such a way so that the sensing mechanism and biocompatible matrix manage a foreign body response to resist barrier cell formation and allow transport of analytes through the passageways to the sensing mechanism when the sensor is implanted into a body.