Analyte monitoring device and methods of use
First Claim
1. A sensor control unit comprising:
- an electrochemical sensor, comprising;
a substrate having a narrow distal region for partial implantation through a skin surface and a wider proximal region, the substrate including at least a first surface and a second surface;
at least one working electrode disposed on the narrow distal region of the substrate and in fluid contact with interstitial fluid under the skin surface, the at least one working electrode formed on the first surface of the substrate;
at least one reference electrode disposed on the narrow distal region of the substrate, the at least one reference electrode formed on the first surface of the substrate;
at least one counter electrode disposed on the narrow distal region of the substrate, the at least one counter electrode formed on the second surface of the substrate;
a plurality of conductive contacts disposed on the wider proximal region of the substrate and on the first surface of the substrate, wherein a first one of the plurality of conductive contacts is in electrical communication with the working electrode, a second one of the plurality of conductive contacts is in electrical communication with the reference electrode, and a third one of the plurality of conductive contacts is in electrical communication with the counter electrode; and
at least one via formed through the substrate that electrically connects the counter electrode to the third one of the plurality of conductive contacts;
a mounting unit adapted for placement on the skin of the subject and to removably support a portion of the electrochemical sensor extending out of the skin of the subject; and
a housing comprising an rf transmitter disposed therein and a plurality of electrical components adapted to couple with the plurality of conductive contacts disposed on the proximal portion of the sensor without intervening wires between the sensor and the housing, wherein the housing is adapted for coupling with the mounting unit.
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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.
2391 Citations
30 Claims
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1. A sensor control unit comprising:
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an electrochemical sensor, comprising; a substrate having a narrow distal region for partial implantation through a skin surface and a wider proximal region, the substrate including at least a first surface and a second surface; at least one working electrode disposed on the narrow distal region of the substrate and in fluid contact with interstitial fluid under the skin surface, the at least one working electrode formed on the first surface of the substrate; at least one reference electrode disposed on the narrow distal region of the substrate, the at least one reference electrode formed on the first surface of the substrate; at least one counter electrode disposed on the narrow distal region of the substrate, the at least one counter electrode formed on the second surface of the substrate; a plurality of conductive contacts disposed on the wider proximal region of the substrate and on the first surface of the substrate, wherein a first one of the plurality of conductive contacts is in electrical communication with the working electrode, a second one of the plurality of conductive contacts is in electrical communication with the reference electrode, and a third one of the plurality of conductive contacts is in electrical communication with the counter electrode; and at least one via formed through the substrate that electrically connects the counter electrode to the third one of the plurality of conductive contacts; a mounting unit adapted for placement on the skin of the subject and to removably support a portion of the electrochemical sensor extending out of the skin of the subject; and a housing comprising an rf transmitter disposed therein and a plurality of electrical components adapted to couple with the plurality of conductive contacts disposed on the proximal portion of the sensor without intervening wires between the sensor and the housing, wherein the housing is adapted for coupling with the mounting unit. - View Dependent Claims (2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21)
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22. A method for monitoring a level of an analyte, the method comprising:
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providing an electrochemical sensor, comprising; a substrate having a narrow distal region for partial implantation through a skin surface and a wider proximal region, the substrate including at least a first surface and a second surface; at least one working electrode disposed on the narrow distal region of the substrate and in fluid contact with interstitial fluid under the skin surface, the at least one working electrode formed on the first surface of the substrate; at least one reference electrode disposed on the narrow distal region of the substrate, the at least one reference electrode formed on the first surface of the substrate; at least one counter electrode disposed on the narrow distal region of the substrate, the at least one counter electrode formed on the second surface of the substrate; a plurality of conductive contacts disposed on the wider proximal region of the substrate and on the first surface of the substrate, wherein a first one of the plurality of conductive contacts is in electrical communication with the working electrode, a second one of the plurality of conductive contacts is in electrical communication with the reference electrode, and a third one of the plurality of conductive contacts is in electrical communication with the counter electrode; and at least one via formed through the substrate that electrically connects the counter electrode to the third one of the plurality of conductive contacts; mounting a mounting unit to the skin of a subject; inserting the sensor into the skin of the subject such that a portion of the sensor extending out of the skin of the subject is removably supported by the mounting unit; providing a sensor control unit including a housing, the housing comprising an rf transmitter disposed therein and a plurality of electrical components adapted to couple to the proximal end of the sensor without intervening wires between the sensor and the housing; coupling the housing and the mounting unit such that each of the plurality of electrical components is coupled to one of the plurality of conductive contacts of the sensor; collecting data, using the sensor control unit, regarding a level of an analyte from signals generated by the sensor; and transmitting the collected data using the rf transmitter of the sensor control unit. - View Dependent Claims (23, 24, 25, 26, 27, 28, 29, 30)
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Specification