Analyte Monitoring Device and Methods of Use

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.

What is claimed is: 
     
         1 . A system, comprising:
 an analyte sensor positioned in fluid contact with interstitial fluid under a skin layer to generate signals associated with a monitored analyte level; and   a receiver unit configured to process the generated signals from the analyte sensor and to receive sensor parameter data related to the analyte sensor, wherein the sensor parameter data is determined prior to positioning the analyte sensor in fluid contact, and further, wherein no user calibration of the analyte sensor is performed after the analyte sensor is positioned in fluid contact with interstitial fluid.   
     
     
         2 . The system of  claim 1 , wherein the analyte sensor is configured to monitor the analyte level of the interstitial fluid. 
     
     
         3 . The system of  claim 1 , wherein the receiver unit includes an output unit to output information associated with the monitored analyte level. 
     
     
         4 . The system of  claim 1 , wherein the receiver unit is further configured to determine a drug delivery profile. 
     
     
         5 . The system of  claim 4 , wherein the drug delivery profile includes an insulin delivery rate. 
     
     
         6 . The system of  claim 1 , wherein the analyte sensor includes a glucose sensor. 
     
     
         7 . The system of  claim 1 , further comprising a data processing unit configured for positioning on the skin layer. 
     
     
         8 . The system of  claim 7 , wherein the data processing unit is operatively coupled to the analyte sensor. 
     
     
         9 . The system of  claim 1 , wherein the analyte sensor comprises a plurality of electrodes including a working electrode, wherein the working electrode comprises an analyte-responsive enzyme and a mediator, wherein at least one of the analyte-responsive enzyme and the mediator is chemically bonded to a polymer disposed on the working electrode, and wherein at least one of the analyte-responsive enzyme and the mediator is crosslinked with the polymer. 
     
     
         10 . The system of  claim 1 , wherein the receiver unit is further configured to process the signals from the analyte sensor using temperature data obtained by a temperature sensor. 
     
     
         11 . The system of  claim 1 , wherein the sensor parameter data includes factory-set calibration data. 
     
     
         12 . The system of  claim 1 , wherein the receiver unit is configured to receive the sensor parameter data related to the analyte sensor. 
     
     
         13 . A method, comprising:
 positioning an analyte sensor in fluid contact with interstitial fluid under a skin layer;   generating signals corresponding to a monitored analyte level with the analyte sensor in fluid contact with the interstitial fluid;   receiving, using a receiver unit, sensor parameter data related to the analyte sensor, wherein the sensor parameter data is determined prior to positioning the analyte sensor in fluid contact under the skin layer; and   processing, using the receiver unit, signals generated by the analyte sensor to determine an analyte concentration level based on the signals from the analyte sensor, wherein no user calibration of the analyte sensor is performed after the analyte sensor is positioned in fluid contact with the interstitial fluid.   
     
     
         14 . The method of  claim 13 , further including determining a drug delivery profile based at least in part on the signals generated by the analyte sensor. 
     
     
         15 . The method of  claim 14 , wherein the drug delivery profile includes an insulin delivery rate. 
     
     
         16 . The method of  claim 13 , further including displaying the analyte concentration level. 
     
     
         17 . The method of  claim 16 , wherein displaying the analyte concentration level includes displaying an indicator associated with processed data. 
     
     
         18 . The method of  claim 17 , wherein the indicator includes one or more of a numeric display, a graphical display, a vibratory display, an audible display, or one or more combinations thereof. 
     
     
         19 . The method of  claim 13 , wherein the analyte sensor comprises a plurality of electrodes including a working electrode, wherein the working electrode comprises an analyte-responsive enzyme and a mediator, wherein at least one of the analyte-responsive enzyme and the mediator is chemically bonded to a polymer disposed on the working electrode, and wherein at least one of the analyte-responsive enzyme and the mediator is crosslinked with the polymer. 
     
     
         20 . The method of  claim 13 , wherein the signals generated by the analyte sensor are processed using temperature data obtained by a temperature sensor. 
     
     
         21 . The method of  claim 13 , wherein the signals generated by the analyte sensor include a signal stream associated with the monitored analyte level over a predetermined time period. 
     
     
         22 . The method of  claim 13 , wherein the analyte sensor includes a glucose sensor. 
     
     
         23 . The method of  claim 13 , wherein the sensor parameter data includes factory-set calibration data. 
     
     
         24 . An apparatus, comprising:
 one or more processors; and   a memory for storing instructions which, when executed by the one or more processors, cause the one or more processors to receive sensor parameter data related to an analyte sensor, wherein the sensor parameter data is determined prior to positioning of the analyte sensor under a skin layer, to process signals generated by the analyte sensor in fluid contact with interstitial fluid, wherein no user calibration of the analyte sensor is performed after the analyte sensor is positioned in fluid contact with the interstitial fluid under the skin layer.   
     
     
         25 . The apparatus of  claim 24 , wherein the memory for storing instructions which, when executed by the one or more processors, further cause the one or more processors to determine a drug delivery profile based at least in part on the data obtained by the analyte sensor. 
     
     
         26 . The apparatus of  claim 25 , wherein the drug delivery profile includes an insulin delivery rate. 
     
     
         27 . The apparatus of  claim 24 , wherein the analyte sensor comprises a plurality of electrodes including a working electrode, wherein the working electrode comprises an analyte-responsive enzyme and a mediator, wherein at least one of the analyte-responsive enzyme and the mediator is chemically bonded to a polymer disposed on the working electrode, and wherein at least one of the analyte-responsive enzyme and the mediator is crosslinked with the polymer. 
     
     
         28 . The apparatus of  claim 24 , wherein the memory for storing instructions which, when executed by the one or more processors, further causes the one or more processors to process the signals generated by the analyte sensor using temperature data obtained by a temperature sensor. 
     
     
         29 . The apparatus of  claim 24 , wherein the signals generated by the analyte sensor include a signal stream associated with a monitored analyte level over a predetermined time period. 
     
     
         30 . The apparatus of  claim 24 , wherein the analyte sensor includes a glucose sensor. 
     
     
         31 . The apparatus of  claim 24 , wherein the sensor parameter data includes factory-set calibration data.