Analyte Monitoring Device and Methods of Use
First Claim
1. A sensor control unit comprising:
- a housing adapted for placement on skin and adapted to receive a portion of an electrochemical sensor having a plurality of contact pads;
a plurality of conductive contacts disposed on the housing and configured for coupling to the plurality of contact pads on the sensor; and
a transmitter disposed in the housing and coupled to the plurality of conductive contacts for transmitting data obtained using the sensor.
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Accused Products
Abstract
An analyte monitor includes a sensor, a sensor control unit, and a display unit. The sensor has, for example, a substrate, a recessed channel formed in the substrate, and conductive material disposed in the recessed channel to form a working electrode. The sensor control unit typically has a housing adapted for placement on skin and is adapted to receive a portion of an electrochemical sensor. The sensor control unit also includes two or more conductive contacts disposed on the housing and configured for coupling to two or more contact pads on the sensor. A transmitter is disposed in the housing and coupled to the plurality of conductive contacts for transmitting data obtained using the sensor. The display unit has a receiver for receiving data transmitted by the transmitter of the sensor control unit and a display coupled to the receiver for displaying an indication of a level of an analyte. The analyte monitor may also be part of a drug delivery system to alter the level of the analyte based on the data obtained using the sensor.
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Citations
120 Claims
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1. A sensor control unit comprising:
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a housing adapted for placement on skin and adapted to receive a portion of an electrochemical sensor having a plurality of contact pads; a plurality of conductive contacts disposed on the housing and configured for coupling to the plurality of contact pads on the sensor; and a transmitter disposed in the housing and coupled to the plurality of conductive contacts for transmitting data obtained using the sensor. - 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, 25, 26, 27, 28, 29, 30, 31, 32, 33, 34, 35, 36, 37, 38, 39, 40, 41, 42, 43, 44, 47, 48, 49, 50, 51, 52, 53, 54, 55, 56, 57, 58, 59, 60, 61, 62, 63, 64, 65, 66, 67, 68, 69, 70, 71, 72, 73, 74, 75, 76, 77, 78, 79, 80, 81, 82, 83, 84, 85, 86, 87, 88, 89, 90, 91, 92, 93, 113, 114, 115, 116, 117, 118, 119, 120)
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45. A sensor assembly, comprising:
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a sensor having a substrate, at least one recessed channel formed in a surface of the substrate, conductive material disposed in the at least one recessed channel to form at least one working electrode and an individual contact pad for each of the at least one working electrodes; and a sensor control unit for placement on a skin of an animal, the sensor control unit including a housing having a port through which the sensor penetrates the housing, and a plurality of conductive contacts disposed in the housing and configured for coupling with the contact pads of the sensor.
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46. A sensor assembly, comprising:
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a sensor comprising a flexible substrate with at least one working electrode, at least one counter electrode, and at least one contact pad coupled to each of the working and counter electrodes; and a sensor control unit comprising a housing adapted for placement on skin; a plurality of conductive contacts disposed on the housing and configured for coupling to the contact pads of the sensor; and a transmitter disposed in the housing and coupled to the plurality of conductive contacts for transmitting data obtained using the sensor.
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94. An insertion kit for inserting an electrochemical sensor into a patient, the insertion kit comprising:
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an inserter comprising a portion having a sharp, rigid, planer structure adapted to support the sensor during insertion of the electrochemical sensor; and an insertion gun having a port configured to accept the electrochemical sensor and the inserter, a driving mechanism for driving the inserter and electrochemical sensor into the patient, and a retraction mechanism for removing the inserter from the patient while leaving the sensor within the patient. - View Dependent Claims (95, 96, 97, 98, 99, 100, 101, 102, 103)
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104. A method of using an electrochemical sensor, the method comprising:
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adhering a mounting unit to a skin of a patient; aligning an insertion gun with a port on the mounting unit, the insertion gun having an electrochemical sensor disposed therein; inserting an electrochemical sensor into the skin of the patient using the insertion gun; removing the insertion gun; mounting a housing of a sensor control unit on the mounting base; and coupling a plurality of conductive contacts disposed on the housing with a plurality of contact pads disposed on the electrochemical sensor. - View Dependent Claims (105, 106, 107)
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108. A method for detecting failures in an implanted analyte-responsive sensor, the method comprising:
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implanting an analyte-responsive sensor into a patient, the analyte-responsive sensor comprising N working electrodes, where N is an integer and is two or greater, and a common counter electrode; obtaining a signal generated at one of the N working electrodes and a signal generated at the common counter electrode; and determining failure of the analyte-responsive sensor if the signal from the common counter electrode is not N times the signal from the one of the N working electrodes, within a predetermined threshold limit.
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109. A method of calibrating an electrochemical sensor implanted in a patient and comprising one or more working electrodes, the method comprising:
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(a) generating a signal from each of the one or more working electrodes; (b) determining if each of conditions (1) to (3) are met (1) the signals from each of the one or more working electrodes differ by less than a first threshold amount, (2) the signals from each of the one or more working electrodes are within a predetermined range, and (3) a rate of change of the signals from each of the one or more working electrodes is less than a second threshold amount. - View Dependent Claims (110, 111, 112)
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Specification