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.

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.   
     
     
         2 - 120 . (canceled) 
     
     
         121 . A method for analyzing data from a continuous analyte sensor, the method comprising:
 receiving data from an analyte sensor;   detecting an occurrence of a signal artifact event; and   processing the received data, wherein the processing is based at least in part upon whether the signal artifact event occurs.   
     
     
         122 . The method of  claim 121 , wherein detecting an occurrence of a signal artifact event comprises determining an amplitude of sensor data and determining an amplitude of a signal artifact. 
     
     
         123 . The method of  claim 122 , wherein detecting an occurrence of a signal artifact event comprises detecting a start of a signal artifact event when an amplitude of a signal artifact meets a first predetermined condition. 
     
     
         124 . The method of  claim 123 , wherein detecting an occurrence of a signal artifact even comprises detecting an end of a signal artifact event when an amplitude of a signal artifact meets a second predetermined condition. 
     
     
         125 . The method of  claim 124 , further comprising filtering the received data to generate filtered data, wherein detecting an occurrence of a signal artifact event comprises comparing received data with filtered data to obtain at least one residual. 
     
     
         126 . The method of  claim 125 , wherein one of the first predetermined condition and the second predetermined condition includes a residual amplitude of a sensor data amplitude. 
     
     
         127 . The method of  claim 125 , wherein detecting an occurrence of a signal artifact event comprises determining a differential between a first residual at a first time point and a second residual at a second time point. 
     
     
         128 . The method of  claim 127 , wherein one of the first predetermined condition or the second predetermined condition includes a differential amplitude of a sensor data amplitude. 
     
     
         129 . The method of  claim 124 , wherein the first predetermined condition is different from the second predetermined condition. 
     
     
         130 . The method of  claim 121 , further comprising filtering the received data to generate filtered data, wherein processing the received data comprises displaying a graphical representation of the filtered data responsive to a determination of a start of a signal artifact event. 
     
     
         131 . The method of  claim 121 , wherein the received data comprises an unfiltered signal, and wherein processing the received data comprises displaying a graphical representation of the unfiltered data responsive to a determination of an end of a signal artifact event. 
     
     
         132 . The method of  claim 121 , wherein the received data comprises an unfiltered signal, and wherein processing the received data comprises displaying a graphical representation of the unfiltered data except when a signal artifact event occurs. 
     
     
         133 . A device comprising a computer readable memory, the computer readable memory containing code for analyzing data from a continuous analyte sensor, wherein the code comprises:
 instructions for receiving data from an analyte sensor, the data comprising at least one sensor data point;   instructions for detecting an occurrence of a signal artifact event; and   instructions for processing the received data, wherein the processing is based at least in part upon whether a signal artifact event has occurred.   
     
     
         134 . The device of  claim 133 , wherein the instructions for detecting an occurrence of a signal artifact event comprise instructions for determining an amplitude of the sensor data and instructions for determining an amplitude of a signal artifact. 
     
     
         135 . The device of  claim 134 , wherein the instructions for detecting an occurrence of a signal artifact event comprise instructions for detecting a start of a signal artifact event when an amplitude of a signal artifact meets a first predetermined condition. 
     
     
         136 . The device of  claim 135 , wherein the instructions for detecting an occurrence of a signal artifact event comprise instructions for detecting an end of a signal artifact event when an amplitude of a signal artifact meets a second predetermined condition. 
     
     
         137 . The device of  claim 136 , wherein the code further comprises instructions for filtering the received data to generate filtered data, wherein the instructions for detecting an occurrence of a signal artifact event comprise instructions for comparing the received data with filtered data to obtain at least one residual. 
     
     
         138 . The device of  claim 137 , wherein one of the first predetermined condition or the second predetermined condition includes a residual amplitude a sensor data amplitude. 
     
     
         139 . The device of  claim 137 , wherein the instructions for detecting an occurrence of a signal artifact event comprise instructions for determining a differential between a first residual at a first time point and a second residual at a second time point. 
     
     
         140 . The device of  claim 139 , wherein one of the first predetermined condition and the second predetermined condition includes a differential amplitude of a sensor data amplitude. 
     
     
         141 . The device of  claim 136 , wherein the first predetermined condition is different from the second predetermined condition. 
     
     
         142 . The device of  claim 133 , wherein the code further comprises instructions for filtering the received data to generate filtered data, wherein the instructions for processing the received data comprise instructions for displaying a graphical representation of filtered data responsive to a determination of a start of a signal artifact event. 
     
     
         143 . The device of  claim 133 , wherein the received data comprises an unfiltered signal, and wherein the instructions for processing the received data comprise instructions for displaying a graphical representation of the unfiltered data responsive to a determination of an end of a signal artifact event. 
     
     
         144 . The device of  claim 133 , wherein the received data comprises an unfiltered signal, and wherein the instructions for processing the received data comprise instructions for displaying a graphical representation of the unfiltered data except when a signal artifact even has occurred. 
     
     
         145 . A system configured to continuously measure an analyte in a host, the system comprising:
 an analyte sensor configured to provide sensor data indicative of an analyte concentration in a host;   electronics operably connected to the sensor and comprising programming configured to detect a signal artifact event, wherein the electronics further comprise programming configured to process the sensor data, wherein the processing is based at least in part upon whether the signal artifact event is detected.   
     
     
         146 . The system of  claim 145 , wherein the programming configured to detect a signal artifact event comprises programming configured to determine an amplitude of the sensor data and programming configured to determine an amplitude of a signal artifact. 
     
     
         147 . The system of  claim 146 , wherein the programming configured to detect a signal artifact even comprises programming configured to detect a start of a signal artifact event when then an amplitude of a signal artifact meets a first predetermined condition. 
     
     
         148 . The system of  claim 147 , wherein the programming configured to detect a signal artifact event comprises programming configured to detect an end of the signal artifact even when an amplitude of a signal artifact meets a second predetermined condition. 
     
     
         149 . The system of  claim 148 , wherein the first predetermined condition is different from the second predetermined condition. 
     
     
         150 . The system of  claim 145 , wherein the electronics further comprise programming configured to filter the sensor data, and wherein the programming configured to process the sensor data comprises programming configured to display a graphical representation of the filtered data responsive to a determination of a start of a signal artifact event. 
     
     
         151 . The system of  claim 145 , wherein the sensor data comprises unfiltered data, and wherein the programming configured to process the sensor data comprises programming configured to display a graphical representation of the unfiltered data responsive to a determination of an end of a signal artifact event. 
     
     
         152 . The system of  claim 145 , wherein the sensor data comprises unfiltered data, and wherein the programming configured to process the sensor data comprises programming configured to display a graphical representation of the unfiltered data except when a signal artifact event has occurred. 
     
     
         153 . The system of  claim 145 , wherein the sensor is configured to be transcutaneously implanted or intravascularly implanted. 
     
     
         154 . The system of  claim 145 , wherein the sensor has a variable stiffness. 
     
     
         155 . The system of  claim 145 , wherein the sensor further comprises a membrane configured to block passage therethrough of at least one interferent. 
     
     
         156 . The system of  claim 155 , wherein the interferent comprises at least one substance selected from the group consisting of hydrogen peroxide, reactive oxygen species, and reactive nitrogen species. 
     
     
         157 . The system of  claim 155 , wherein the interferent comprises at least one substance selected from the group consisting of acetaminophen, ascorbic acid, salicylic acid, and uric acid. 
     
     
         158 . The system of  claim 155 , wherein the membrane is configured to substantially block passage therethrough of at least one non-constant noise causing interferent. 
     
     
         159 . A method for analyzing data from a continuous analyte sensor, the method comprising:
 receiving data from an analyte sensor;   detecting an occurrence of a signal artifact event based at least in part on an amplitude of a signal artifact, including detecting a start and an end of a signal artifact event; and   processing the received data, wherein the processing is based at least in part upon whether the signal artifact event occurs.   
     
     
         160 . The method of  claim 159 , wherein detecting the occurrence of a signal artifact event comprises determining an amplitude of sensor data and determining an amplitude of a signal artifact. 
     
     
         161 . The method of  claim 160 , wherein detecting the occurrence of a signal artifact event comprises detecting a start of a signal artifact event when an amplitude of a signal artifact meets a first predetermined condition. 
     
     
         162 . The method of  claim 161 , wherein detecting the occurrence of a signal artifact event comprises detecting an end of a signal artifact event when an amplitude of a signal artifact meets a second predetermined condition. 
     
     
         163 . The method of  claim 162 , wherein the first predetermined condition is different from the second predetermined condition. 
     
     
         164 . The method of  claim 159 , wherein detecting an occurrence of a signal artifact event comprises comparing received data with filtered data to obtain at least one residual. 
     
     
         165 . The method of  claim 164 , wherein one of the first predetermined condition or the second predetermined condition includes a residual amplitude of a sensor data amplitude. 
     
     
         166 . The method of  claim 159 , wherein detecting an occurrence of a signal artifact event comprises determining a differential between a first residual at a first time point and a second residual at a second time point. 
     
     
         167 . The method of  claim 166 , wherein one of the first predetermined condition or the second predetermined condition includes a differential amplitude of a sensor data amplitude. 
     
     
         168 . The method of  claim 159 , wherein processing the received data comprises displaying a graphical representation of filtered data responsive to a determination of a start of a signal artifact event. 
     
     
         169 . The method of  claim 159 , wherein the received data comprises unfiltered data, and wherein processing the received data comprises displaying a graphical representation of the unfiltered data responsive to a determination of an end of a signal artifact event. 
     
     
         170 . The method of  claim 159 , wherein processing the received data comprises displaying a graphical representation of the unfiltered data except when a signal artifact event occurs. 
     
     
         171 . A method for displaying data from a continuous analyte sensor, the method comprising:
 receiving data from an analyte sensor, including at least one of unfiltered data and filtered data;   detecting an occurrence of a signal artifact event based at least in part on an amplitude of a signal artifact, including detecting a start and an end of a signal artifact event; and   displaying a graphical representation of filtered data responsive to a determination of a start of a signal artifact event.   
     
     
         172 . The method of  claim 171 , wherein the received data comprises unfiltered data, and wherein processing the received data comprises displaying a graphical representation of the unfiltered data responsive to a determination of an end of a signal artifact event. 
     
     
         173 . The method of  claim 171 , wherein processing the received data comprises displaying a graphical representation of the unfiltered data except when a signal artifact event occurs. 
     
     
         174 . A device comprising a computer readable memory, the computer readable memory containing code for analyzing data from a continuous analyte sensor, wherein the code comprises:
 instructions for receiving data from an analyte sensor, the data comprising at least one sensor data point;   instructions for detecting an occurrence of a signal artifact event based at least in part on an amplitude of a signal artifact; and   instructions for processing the received data, wherein the processing is based at least in part upon whether a signal artifact event has occurred.   
     
     
         175 . The device of  claim 174 , wherein the instructions for detecting an occurrence of a signal artifact event comprise instructions for determining an amplitude of the sensor data and instructions for determining an amplitude of a signal artifact. 
     
     
         176 . The device of  claim 175 , wherein the instructions for detecting an occurrence of a signal artifact event comprise instructions for detecting a start of a signal artifact event when an amplitude of a signal artifact meets a first predetermined condition. 
     
     
         177 . The device of  claim 176 , wherein the instructions for detecting an occurrence of a signal artifact event comprise instructions for detecting an end of a signal artifact event when an amplitude of a signal artifact meets a second predetermined condition. 
     
     
         178 . The device of  claim 177 , wherein the first predetermined condition is different from the second predetermined condition. 
     
     
         179 . The device of  claim 176 , wherein the instructions for detecting an occurrence of a signal artifact event comprise instructions for comparing the received data with filtered data to obtain at least one residual. 
     
     
         180 . The device of  claim 178 , wherein one of the first predetermined condition and the second predetermined condition includes a residual amplitude of a sensor data amplitude. 
     
     
         181 . The device of  claim 174 , wherein the instructions for detecting an occurrence of a signal artifact event comprise instructions for determining a differential between a first residual at a first time point and a second residual at a second time point. 
     
     
         182 . The device of  claim 180 , wherein one of the first predetermined condition or the second predetermined condition includes a differential amplitude of a sensor data amplitude. 
     
     
         183 . A device comprising a computer readable memory, the computer readable memory containing code for displaying data from a continuous analyte sensor, wherein the code comprises:
 instructions for receiving data from an analyte sensor, the data comprising at least one unfiltered or filtered sensor data point;   instructions for detecting an occurrence of a signal artifact event based at least in part on an amplitude of a signal artifact event; and   instructions for displaying a graphical representation of filtered data responsive to a determination of a start of a signal artifact event.   
     
     
         184 . The device of  claim 183 , wherein the received data comprises an unfiltered signal, and wherein the instructions for processing the received data comprise instructions for displaying a graphical representation of the unfiltered data responsive to a determination of an end of a signal artifact event. 
     
     
         185 . The device of  claim 183 , wherein the received data comprises an unfiltered signal, and wherein the instructions for processing the received data comprise instructions for displaying a graphical representation of the unfiltered data except when a signal artifact event has occurred. 
     
     
         186 . A system configured to continuously measure an analyte in a host, the system comprising:
 an analyte sensor configured to provide sensor data indicative of an analyte concentration in a host;   electronics operably connected to the sensor and comprising programming configured to detect a signal artifact event based at least in part on an amplitude of a signal artifact, including detecting a start and an end of a signal artifact event, wherein the electronics further comprise programming configured to process the sensor data, wherein the processing is based at least in part upon whether the signal artifact event is detected.   
     
     
         187 . The system of  claim 186 , wherein the programming configured to detect a signal artifact event comprises programming configured to determine an amplitude of the sensor data and programming configured to determine an amplitude of a signal artifact. 
     
     
         188 . The system of  claim 187 , wherein the programming configured to detect a signal artifact event comprises programming configured to detect a start of a signal artifact event when then an amplitude of a signal artifact meets a first predetermined condition. 
     
     
         189 . The system of  claim 188 , wherein the programming configured to detect a signal artifact event comprises programming configured to detect an end of a signal artifact event when an amplitude of a signal artifact meets a second predetermined condition. 
     
     
         190 . A system configured to continuously measure an analyte in a host, the system comprising:
 an analyte sensor configured to provide sensor data indicative of an analyte concentration in a host;   electronics operably connected to the sensor and comprising programming configured to detect a signal artifact event based at least in part on an amplitude of a signal artifact, and wherein the programming configured to process the sensor data comprises programming configured to display a graphical representation of filtered data responsive to a determination of a start of a signal artifact event.   
     
     
         191 . The system of  claim 190 , wherein the sensor data comprises unfiltered data, and wherein the programming configured to process the sensor data comprises programming configured to display a graphical representation of the unfiltered data responsive to a determination of an end of a signal artifact event. 
     
     
         192 . The system of  claim 190 , wherein the sensor data comprises unfiltered data, and wherein the programming configured to process the sensor data comprises programming configured to display a graphical representation of the unfiltered data except when a signal artifact event has occurred.