SUBCUTANEOUS GLUCOSE ELECTRODE
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Abstract
A small diameter flexible electrode designed for subcutaneous in vivo amperometric monitoring of glucose is described. The electrode is designed to allow “one-point” in vivo calibration, i.e., to have zero output current at zero glucose concentration, even in the presence of other electroreactive species of serum or blood. The electrode is preferably three or four-layered, with the layers serially deposited within a recess upon the tip of a polyamide insulated gold wire. A first glucose concentration-to-current transducing layer is overcoated with an electrically insulating and glucose flux limiting layer (second layer) on which, optionally, an immobilized interference-eliminating horseradish peroxidase based film is deposited (third layer). An outer (fourth) layer is biocompatible.
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Citations
53 Claims
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2-20. -20. (canceled)
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21. A method for fabricating an analyte sensor configured for insertion into a host'"'"'s soft tissue, the method comprising:
- forming a biointerface having a plurality of passageways and a solid portion on at least a sensing portion of a sensor, wherein the sensor is configured to measure an analyte in the host, and wherein the sensor has an architecture with at least one dimension less than about 1 mm.
- View Dependent Claims (1, 22, 23, 24, 25, 26, 27, 28, 29, 30, 33, 34, 35)
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26-1. The method of claim 21, wherein the step of forming a biointerface comprises:
- forming a selectively removable porogen on the sensor, wherein the porogen comprises particles formed onto the sensor and solidified to form a solidified mass of continuously interconnected particles;
filling the porogen with a material;
substantially solidifying the material; and
removing the mass of continuously interconnected particles from contact with the sensor and solidified material to thereby form a solid portion that defines a plurality of passageways of the biointerface.
- forming a selectively removable porogen on the sensor, wherein the porogen comprises particles formed onto the sensor and solidified to form a solidified mass of continuously interconnected particles;
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31. The method of claim 31, wherein the biointerface comprises fibers less than about 6 microns in all but the longest dimension.
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36. A method for fabricating an analyte sensor configured to be wholly implanted in a host'"'"'s soft tissue, the method comprising:
- providing a sensor configured to measure an analyte in the host, wherein the sensor has an architecture with at least one dimension less than about 1 mm; and
coating a biointerface onto the sensor, the biointerface comprising a plurality of cavities and a solid portion. - View Dependent Claims (37, 38, 39, 40, 41, 42, 43, 44, 45, 46, 47, 48, 49)
- providing a sensor configured to measure an analyte in the host, wherein the sensor has an architecture with at least one dimension less than about 1 mm; and
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50. A method for making an analyte sensor configured for insertion into a host'"'"'s soft tissue, the method comprising:
- providing a sensor configured to measure an analyte in a host, wherein the sensor has an architecture with at least one dimension less than about 1 mm; and
directly writing a porous biointerface, wherein the porous biointerface is written based on a predefined pattern stored in a computer system. - View Dependent Claims (51, 52, 53)
- providing a sensor configured to measure an analyte in a host, wherein the sensor has an architecture with at least one dimension less than about 1 mm; and
Specification