Analyte monitoring device and methods of use
First Claim
1. A sensor control unit comprising:
- an analyte sensor 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; and
a water resistant housing for placement on skin and configured to receive the analyte sensor substrate, wherein at least a portion of the wider proximal region the analyte sensor substrate is contained within the water resistant housing and wherein at least a portion of the narrow distal region of the analyte sensor substrate protrudes from a sensor port disposed on a base of the water resistant housing; and
a plurality of electronic components disposed in the water resistant housing, wherein at least one of the plurality of electronic components is in electrical contact with the plurality of conductive contacts disposed on the wider proximal region of the analyte sensor substrate, and wherein the at least one of the plurality of electronic components is configured to;
receive data from a display device;
receive a sensor signal from the sensor; and
transmit the sensor signal to the display device.
3 Assignments
0 Petitions
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.
2384 Citations
30 Claims
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1. A sensor control unit comprising:
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an analyte sensor 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; and a water resistant housing for placement on skin and configured to receive the analyte sensor substrate, wherein at least a portion of the wider proximal region the analyte sensor substrate is contained within the water resistant housing and wherein at least a portion of the narrow distal region of the analyte sensor substrate protrudes from a sensor port disposed on a base of the water resistant housing; and a plurality of electronic components disposed in the water resistant housing, wherein at least one of the plurality of electronic components is in electrical contact with the plurality of conductive contacts disposed on the wider proximal region of the analyte sensor substrate, and wherein the at least one of the plurality of electronic components is configured to; receive data from a display device; receive a sensor signal from the sensor; and transmit the sensor signal to the display device. - View Dependent Claims (2, 3, 4, 5, 6)
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7. An analyte monitoring system, comprising:
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an analyte sensor, including; an analyte sensor 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; and a water resistant housing for placement on skin and configured to receive the analyte sensor substrate, wherein at least a portion of the wider proximal region the analyte sensor substrate is contained within the water resistant housing and wherein at least a portion of the narrow distal region of the analyte sensor substrate protrudes from a sensor port disposed on a base of the water resistant housing; and a plurality of electronic components disposed in the water resistant on-skin housing, wherein at least one of the plurality of electronic components is in electrical contact with the plurality of conductive contacts disposed on the wider proximal region of the analyte sensor substrate, and wherein the at least one of the plurality of electronic components is configured to; receive a signal from an external device; and provide sensor data to the external device. - View Dependent Claims (8, 9, 10, 11, 12, 13)
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14. A method for monitoring an analyte using, at least in part, a sensor control unit, the method comprising:
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implanting a first portion of a sensor into subcutaneous tissue of a patient for fluid contact with interstitial fluid, the sensor including; an analyte sensor 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; and operatively coupling the plurality of conductive contacts disposed on the wider proximal region of the analyte sensor substrate to at least one electronic component disposed within a water resistant housing of the sensor control unit, wherein the water resistant housing is configured for placement on skin and configured to receive the analyte sensor substrate, wherein at least a portion of the wider proximal region the analyte sensor substrate is contained within the water resistant housing and wherein at least a portion of the narrow distal region of the analyte sensor substrate protrudes from a sensor port disposed on a base of the water resistant housing; receiving a signal from an external device, wherein the signal is received by the at least one electronic component; and providing sensor data from the at least one electronic component to the external device. - View Dependent Claims (15, 16, 17, 18, 19)
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20. A sensor control system, comprising:
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a sensor for monitoring an analyte, the sensor including; an analyte sensor 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; and an on skin housing unit configured to prevent water from penetrating therethrough when the on skin housing unit is in contact with water and further configured to receive the analyte sensor substrate, wherein at least a portion of the wider proximal region the analyte sensor substrate is contained within the on skin housing unit and wherein at least a portion of the narrow distal region of the analyte sensor substrate protrudes from a sensor port disposed on a base of the on skin housing unit; and a plurality of electronic components disposed in the on skin housing unit, wherein at least one of the plurality of electronic components is in electrical contact with the plurality of conductive contacts disposed on the wider proximal region of the analyte sensor substrate, and wherein the at least one of the plurality of electronic components is configured to; receive a signal from a display device; and provide sensor data to the display device. - View Dependent Claims (21, 22, 23, 24, 25, 26)
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27. An analyte monitoring system, comprising:
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a sensor configured for in vivo monitoring of analyte levels in a fluid, the sensor comprising; an analyte sensor 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; and a sensor control unit comprising; an on skin housing unit configured to prevent water from penetrating therethrough when the on skin housing unit is in contact with water and further configured to receive the analyte sensor substrate, wherein at least a portion of the wider proximal region the analyte sensor substrate is contained within the on skin housing unit and wherein at least a portion of the narrow distal region of the analyte sensor substrate protrudes from a sensor port disposed on a base of the on skin housing unit; and a plurality of electronic components disposed in the on skin housing unit, wherein at least one of the plurality of electronic components is in electrical contact with the plurality of conductive contacts disposed on the wider proximal region of the analyte sensor substrate, and wherein the at least one of the plurality of electronic components is configured to; receive a signal from an external device; and provide sensor data to the external device. - View Dependent Claims (28, 29, 30)
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Specification