Lyotropic Liquid Crystal Coated Analyte Monitoring Device and Methods of Use

Abstract

Analyte sensor assemblies comprising: an electrochemical sensor for determining a concentration of an analyte and an electrochemical sensor control unit. The electrochemical sensor comprising a working electrode having a sensing layer and a non-crosslinked cubic phase lyotropic liquid crystal membrane disposed over the sensing layer, the sensing layer comprising an analyte-responsive enzyme, and a counter electrode in communication with the working electrode. And the electrochemical sensor control unit comprising a housing adapted for placement on or implantation in a patient's skin, and sensor control unit electronics. Wherein a measured current from an applied potential between the working electrode and the counter electrode correlates to a concentration of an analyte.

What is claimed is: 
     
         1 . An analyte sensor assembly comprising:
 an electrochemical sensor for determining a concentration of an analyte comprising:
 a working electrode having a sensing layer and a non-crosslinked cubic phase lyotropic liquid crystal membrane disposed over the sensing layer, the sensing layer comprising an analyte-responsive enzyme, and 
 a counter electrode in communication with the working electrode,
 wherein a measured current from an applied potential between the working electrode and the counter electrode correlates to a concentration of an analyte; and 
 
   an electrochemical sensor control unit comprising:
 a housing adapted for placement on or implantation in a patient's skin, and 
 sensor control unit electronics. 
   
     
     
         2 . The analyte sensor assembly of  claim 1 , wherein the electrochemical sensor is factory precalibrated. 
     
     
         3 . The analyte sensor assembly of  claim 1 , wherein the housing adapted for placement on or implantation in a patient's skin is so adapted for a location selected from the group consisting of the patent's thigh, leg, upper arm, shoulder, abdomen, and any combination thereof. 
     
     
         4 . The analyte sensor assembly of  claim 1 , wherein the sensor control electronics are selected from the group consisting of a power supply, a sensor circuit, a measurement circuit, a transmitter, a data storage unit, a temperature probe circuit, a reference voltage generator, a watchdog circuit, an alarm system, and any combination thereof. 
     
     
         5 . The analyte sensor assembly of  claim 1 , wherein the sensing layer further comprises a redox mediator. 
     
     
         6 . The analyte sensor assembly of  claim 1 , wherein the cubic phase lyotropic liquid crystal is non-hydrolyzable in the presence of a lipase. 
     
     
         7 . The analyte sensor assembly of  claim 1 , wherein the cubic phase lyotropic liquid crystal has the formula: 
       
         
           
           
               
               
           
         
       
     
     
         8 . The analyte sensor assembly of  claim 1 , wherein the cubic phase lyotropic liquid crystal membrane limits the flux of the analyte thereacross. 
     
     
         9 . The analyte sensor assembly of  claim 1 , wherein the cubic phase lyotropic liquid crystal membrane has a thickness in the range of about 5 μm to about 3 mm. 
     
     
         10 . The analyte sensor assembly of  claim 1 , wherein the analyte is glucose, lactate, cholesterol, bilirubin, or an amino acid. 
     
     
         11 . An analyte sensor assembly comprising:
 an electrochemical sensor for determining a concentration of an analyte comprising:
 a working electrode having a sensing layer and a non-crosslinked cubic phase lyotropic liquid crystal membrane disposed over the sensing layer, the sensing layer comprising an analyte-responsive enzyme, 
 a counter electrode in communication with the working electrode
 wherein a measured current from an applied potential between the working electrode and the counter electrode correlates to an analyte concentration, and 
 
 at least one contact pad coupled to each of the working electrode and the counter electrode; 
   an electrochemical sensor control unit comprising:
 a housing adapted for placement on or implantation in a patient's skin, 
 sensor control unit electronics, and 
 a conductive contact disposed on the on the housing and configured for coupling to the at least one contact pad coupled to each of the working electrode and the counter electrode; and 
   a transmitter disposed in the housing and configured for coupling to the conductive contracts for transmitting data.   
     
     
         12 . The analyte sensor assembly of  claim 11 , wherein the electrochemical sensor is factory precalibrated. 
     
     
         13 . The analyte sensor assembly of  claim 11 , wherein the housing adapted for placement on or implantation in a patient's skin is so adapted for a location selected from the group consisting of the patent's thigh, leg, upper arm, shoulder, abdomen, and any combination thereof. 
     
     
         14 . The analyte sensor assembly of  claim 11 , wherein the sensor control electronics are selected from the group consisting of a power supply, a sensor circuit, a measurement circuit, a data storage unit, a temperature probe circuit, a reference voltage generator, a watchdog circuit, an alarm system, and any combination thereof. 
     
     
         15 . The analyte sensor assembly of  claim 11 , wherein the sensing layer further comprises a redox mediator. 
     
     
         16 . The analyte sensor assembly of  claim 11 , wherein the cubic phase lyotropic liquid crystal is non-hydrolyzable in the presence of a lipase. 
     
     
         17 . The analyte sensor assembly of  claim 11 , wherein the cubic phase lyotropic liquid crystal has the formula: 
       
         
           
           
               
               
           
         
       
     
     
         18 . The analyte sensor assembly of  claim 11 , wherein the cubic phase lyotropic liquid crystal membrane limits the flux of the analyte thereacross. 
     
     
         19 . The analyte sensor assembly of  claim 11 , wherein the cubic phase lyotropic liquid crystal membrane has a thickness in the range of about 5 μm to about 3 mm. 
     
     
         20 . The analyte sensor assembly of  claim 11 , wherein the analyte is glucose, lactate, cholesterol, bilirubin, or an amino acid.