Subcutaneous Glucose Electrode
First Claim
1. An electrochemical sensor for measuring an analyte in an animal comprising:
- one or more non-corroding metal or carbon electrodes adapted for at least partial subcutaneous implantation in an animal;
a sensing layer comprising an enzyme disposed adjacent to each electrode; and
wherein the electrochemical sensor has a glucose sensitivity selected from the range of about an order of magnitude less than 61 pA/mg/dL to about 300 pA/mg/dL.
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Accused Products
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.
118 Citations
40 Claims
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1. An electrochemical sensor for measuring an analyte in an animal comprising:
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one or more non-corroding metal or carbon electrodes adapted for at least partial subcutaneous implantation in an animal; a sensing layer comprising an enzyme disposed adjacent to each electrode; and wherein the electrochemical sensor has a glucose sensitivity selected from the range of about an order of magnitude less than 61 pA/mg/dL to about 300 pA/mg/dL. - View Dependent Claims (2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23, 24)
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25. An electrochemical sensor for measuring an analyte in an animal, comprising:
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one or more analyte responsive electrodes, at least one of said analyte-responsive electrodes adapted for subcutaneous implantation in an animal, each of the analyte responsive electrodes comprising a non-corroding metal or carbon electrode, a sensing layer covering at least a portion of each non-corroding metal or carbon electrode, comprising a redox enzyme and a redox compound, wherein the redox enzyme is non-leachable by fluids in the body of the animal at a pH of between about 6.5 and about 7.8, and an alarm coupled to the non-corroding metal or carbon electrode configured to activate if a signal generated at the electrode indicates at least one of impending hypoglycemia and impending hyperglycemia. - View Dependent Claims (26, 27, 28, 29, 30, 31, 32, 33, 34, 35, 36, 37, 38)
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39. A method of calibrating an electrochemical sensor at least partially implanted in an animal, comprising the steps of:
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withdrawing a calibration sample from an animal during a time period, wherein the time period is selected such that the analyte concentration remains substantially constant during the time period; assaying an analyte concentration of the calibration sample; correlating the assayed analyte concentration to a signal generated by one or more implanted working electrodes of an electrochemical sensor to calibrate the electrochemical sensor, each working electrode having an analyte-responsive enzyme disposed thereon. - View Dependent Claims (40)
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Specification