Analyte monitoring device and methods of use
First Claim
1. An analyte monitoring system, comprising:
- a transcutaneous analyte sensor including a conductive trace comprising a working electrode having an analyte responsive enzyme disposed on at least a portion of the working electrode, the analyte sensor positioned in fluid contact with a bodily fluid and adapted to monitor an analyte level in the bodily fluid during an entire sensor lifetime from when the sensor is initially positioned in fluid contact with the bodily fluid and continuously operating to generate signals representative of the analyte level of the bodily fluid until the analyte sensor is removed for replacement;
sensor electronics including an application specific integrated circuit electrically coupled to the conductive trace of the sensor, the application specific integrated circuit configured to process signals representative of the analyte level of the bodily fluid received from the sensor, the sensor electronics generating data representative of the monitored analyte level using a factory determined calibration data during the entire sensor lifetime of at least one week, wherein the application specific integrated circuit is configured to encrypt the generated data for transmission; and
a remote device that receives the encrypted data representative of the monitored analyte level generated by the sensor electronics, the remote device configured to evaluate whether the encrypted data are signals from a source other than the sensor electronics by at least decrypting the received encrypted data and comparing the decrypted data with a predetermined range of physiologically relevant values, and, in response to determining the encrypted data are from the sensor electronics, to display real time analyte level information and a rate of change information of analyte level based on the decrypted data.
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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
28 Claims
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1. An analyte monitoring system, comprising:
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a transcutaneous analyte sensor including a conductive trace comprising a working electrode having an analyte responsive enzyme disposed on at least a portion of the working electrode, the analyte sensor positioned in fluid contact with a bodily fluid and adapted to monitor an analyte level in the bodily fluid during an entire sensor lifetime from when the sensor is initially positioned in fluid contact with the bodily fluid and continuously operating to generate signals representative of the analyte level of the bodily fluid until the analyte sensor is removed for replacement; sensor electronics including an application specific integrated circuit electrically coupled to the conductive trace of the sensor, the application specific integrated circuit configured to process signals representative of the analyte level of the bodily fluid received from the sensor, the sensor electronics generating data representative of the monitored analyte level using a factory determined calibration data during the entire sensor lifetime of at least one week, wherein the application specific integrated circuit is configured to encrypt the generated data for transmission; and a remote device that receives the encrypted data representative of the monitored analyte level generated by the sensor electronics, the remote device configured to evaluate whether the encrypted data are signals from a source other than the sensor electronics by at least decrypting the received encrypted data and comparing the decrypted data with a predetermined range of physiologically relevant values, and, in response to determining the encrypted data are from the sensor electronics, to display real time analyte level information and a rate of change information of analyte level based on the decrypted data. - View Dependent Claims (2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 21)
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15. An analyte monitoring method, comprising:
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positioning a transcutaneous analyte sensor in continuous fluid contact with a bodily fluid during an entire sensor lifetime from when the analyte sensor is initially positioned in fluid contact with the bodily fluid and continuously operating to generate signals representative of the analyte level of the bodily fluid until the analyte sensor is removed for replacement, the analyte sensor including a conductive trace comprising a working electrode having an analyte responsive enzyme disposed on at least a portion of the working electrode; generating data representative of the monitored analyte level with sensor electronics including an application specific integrated circuit, wherein the signals generated by the analyte sensor during the continuous operation are processed by the sensor electronics using a factory determined calibration data during the entire sensor lifetime of at least one week, and encrypted by the application specific integrated circuit; wirelessly receiving the encrypted data from the sensor electronics; evaluating whether the encrypted data are signals from a source other than the sensor electronics by at least decrypting, at a remote device, the encrypted data wirelessly received from the sensor electronics and comparing the decrypted data with a predetermined range of physiologically relevant values; and in response to determining the encrypted data are from the sensor electronics, generating analyte level information at the remote device using the decrypted data to display real time analyte level information and a rate of change of analyte level based on the decrypted data. - View Dependent Claims (16, 17, 18, 19, 20, 22, 23, 24, 25, 26, 27, 28)
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Specification