Subcutaneous glucose electrode
First Claim
1. An analyte measurement system, comprising:
- at least one sensor introducer;
a first electrochemical sensor having at least one electrode with an analyte response enzyme thereon, the first electrochemical sensor coupleable to the at least one sensor introducer for positioning at least a portion of the first electrochemical sensor under a skin surface;
a second electrochemical sensor having at least one electrode with an analyte response enzyme thereon, the second electrochemical sensor coupleable to the at least one sensor introducer for positioning at least a portion of the second electrochemical sensor under a skin surface; and
a device configured to normalize a signal obtained from the first electrochemical sensor with respect to a signal obtained from the second electrochemical sensor, to determine a standard deviation for a difference between the normalized signal of the first electrochemical sensor and the signal obtained from the second electrochemical sensor, to reject the signals of the first electrochemical sensor and the second electrochemical sensor that differ by more than the standard deviation, and to calibrate the signal obtained from the first electrochemical sensor based on a calibration factor.
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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.
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Citations
21 Claims
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1. An analyte measurement system, comprising:
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at least one sensor introducer; a first electrochemical sensor having at least one electrode with an analyte response enzyme thereon, the first electrochemical sensor coupleable to the at least one sensor introducer for positioning at least a portion of the first electrochemical sensor under a skin surface; a second electrochemical sensor having at least one electrode with an analyte response enzyme thereon, the second electrochemical sensor coupleable to the at least one sensor introducer for positioning at least a portion of the second electrochemical sensor under a skin surface; and a device configured to normalize a signal obtained from the first electrochemical sensor with respect to a signal obtained from the second electrochemical sensor, to determine a standard deviation for a difference between the normalized signal of the first electrochemical sensor and the signal obtained from the second electrochemical sensor, to reject the signals of the first electrochemical sensor and the second electrochemical sensor that differ by more than the standard deviation, and to calibrate the signal obtained from the first electrochemical sensor based on a calibration factor. - View Dependent Claims (2, 3, 4, 5, 6, 7, 8, 17, 18, 19, 20, 21)
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9. A method, comprising:
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positioning, using a sensor introducer, at least a portion of at least one electrode of a first electrochemical sensor having analyte response enzyme thereon, in fluid contact with interstitial fluid, the first electrochemical sensor coupleable to the sensor introducer; positioning, using the sensor introducer, at least a portion of at least one electrode of a second electrochemical sensor having analyte response enzyme thereon, in fluid contact with interstitial fluid, the second electrochemical sensor coupleable to the sensor introducer; normalizing, using a device, a signal obtained from the first electrochemical sensor with respect to a signal obtained from the second electrochemical sensor; determining, using the device, a standard deviation for a difference between the normalized signal of the first electrochemical sensor and the signal obtained from the second electrochemical sensor; rejecting, using the device, the signals of the first electrochemical sensor and the second electrochemical sensor that differ by more than the standard deviation; and calibrating, using the device, the signal obtained from the first electrochemical sensor based on a calibration factor. - View Dependent Claims (10, 11, 12, 13, 14, 15, 16)
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Specification