Subcutaneous glucose electrode
First Claim
1. A method of monitoring glucose levels in a human, in-vivo, the method comprising:
- (1) subcutaneously implanting in a human, and placing in contact with a glucose-containing body fluid inside the human, a first electrochemical glucose sensor that produces substantially no signal output when the concentration of glucose is zero in the fluid;
(2) determining a glucose level of the human using a second glucose sensor;
(3) measuring a first electrical signal representative of glucose concentration in the fluid from the first sensor;
(4) calibrating the first sensor using the first electrical signal and glucose level determined in step (2);
(5) measuring additional electrical signals representative of glucose concentration in the fluid from the first sensor for a period of at least about 36 hours; and
(6) determining glucose concentration based on the electrical signals measured in step (5) and calibration in step (4) without further calibration.
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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.
1842 Citations
29 Claims
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1. A method of monitoring glucose levels in a human, in-vivo, the method comprising:
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(1) subcutaneously implanting in a human, and placing in contact with a glucose-containing body fluid inside the human, a first electrochemical glucose sensor that produces substantially no signal output when the concentration of glucose is zero in the fluid;
(2) determining a glucose level of the human using a second glucose sensor;
(3) measuring a first electrical signal representative of glucose concentration in the fluid from the first sensor;
(4) calibrating the first sensor using the first electrical signal and glucose level determined in step (2);
(5) measuring additional electrical signals representative of glucose concentration in the fluid from the first sensor for a period of at least about 36 hours; and
(6) determining glucose concentration based on the electrical signals measured in step (5) and calibration in step (4) without further calibration. - View Dependent Claims (2, 3, 4, 5, 6, 7, 25)
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8. A method of monitoring, in-vivo, glucose levels in a human, the method comprising:
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(1) subcutaneously implanting in a human, and placing in contact with a glucose-containing body fluid inside the human, a first electrochemical glucose sensor that produces substantially no signal output when the concentration of glucose is zero in the fluid;
(2) calibrating the electrochemical sensor using a single glucose concentration measurement from a withdrawn blood sample, using a second sensor; and
(3) monitoring glucose concentration using the first sensor, for a period of at least 36 hours, without further calibration. - View Dependent Claims (9, 10, 11, 12, 13, 26, 27)
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14. A method of monitoring glucose levels, in-vivo, in a human, the method comprising:
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(1) subcutaneously implanting in a human, and placing in contact with a glucose-containing body fluid inside the human, a first electrochemical glucose sensor, and monitoring glucose concentration, using the implanted sensor for a period of at least 36 hours; and
(2) calibrating the electrochemical sensor using a single glucose concentration measurement from a withdrawn fluid sample. - View Dependent Claims (15, 16, 17)
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18. An in-vivo method of assaying glucose levels in a human, the method comprising:
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(1) subcutaneously implanting in a human, and placing in contact with a glucose-containing body fluid inside the human, a first electrochemical glucose sensor that produces substantially no signal output when the concentration of glucose is zero in the fluid;
(2) determining a glucose level from a withdrawn sample from the human using a second glucose sensor;
(3) assaying glucose levels by monitoring electrical signals from the first sensor for a period of at least about 36hours; and
(4) calibrating the first glucose sensor for the period using the glucose level from the withdrawn sample as the only calibration sample. - View Dependent Claims (19, 20, 21, 22, 23, 24, 28, 29)
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Specification