Analyte Sensors Having a Membrane with Low Temperature Sensitivity

Abstract

Embodiments of the present disclosure relate to analyte determining methods and devices (e.g., electrochemical analyte monitoring systems) that have a membrane with low temperature sensitivity. The sensing layer is disposed on a working electrode of in vivo and/or in vitro analyte sensors, e.g., continuous and/or automatic in vivo monitoring using analyte sensors and/or test strips. Also provided are systems and methods of using the, for example electrochemical, analyte sensors in analyte monitoring.

1 - 67 . (canceled) 
     
     
         68 . An electrode assembly, comprising:
 an electrode;   a sensing layer disposed on the electrode, the sensing layer comprising an analyte responsive enzyme; and   a diffusion limiting polymeric membrane disposed on the sensing layer, wherein the polymeric membrane comprises a pyridine-based polymer, an ethylene oxide substituent, and a propylene oxide substituent,   wherein diffusion of an analyte through the diffusion limiting membrane to the sensing layer does not change more than 5% per ° C. over a range of physiological temperatures.   
     
     
         69 . The electrode assembly of  claim 68 , wherein the sensing layer comprises a glucose-responsive enzyme. 
     
     
         70 . The electrode assembly of  claim 69 , wherein the glucose-responsive enzyme comprises glucose oxidase. 
     
     
         71 . The electrode assembly of  claim 70 , wherein the sensing layer further comprises a redox mediator. 
     
     
         72 . The electrode assembly of  claim 71 , wherein the redox mediator comprises a ruthenium-containing complex or an osmium-containing complex. 
     
     
         73 . The electrode assembly of  claim 71 , wherein the redox mediator is bound to a polymer. 
     
     
         74 . The electrode assembly of  claim 68 , wherein the analyte responsive enzyme is bound to a polymer. 
     
     
         75 . The electrode assembly of  claim 68 , wherein the pyridine-based polymer comprises a poly(4-vinylpyridine)-co-polystyrene polymer. 
     
     
         76 . The electrode assembly of  claim 68 , wherein the polymer comprises a compound of the formula: 
       
         
           
           
               
               
           
         
         wherein x and y are each positive integers and the ratio of x to y is 1:1. 
       
     
     
         77 . The electrode assembly of  claim 68 , further comprising a counter electrode and a reference electrode. 
     
     
         78 . The electrode assembly of  claim 68 , wherein at least a portion of the analyte sensor is adapted to be subcutaneously positioned in a subject. 
     
     
         79 . A method for monitoring a level of an analyte using an analyte monitoring system, the method comprising:
 inserting at least a portion of an electrode assembly according to  claim 68  into skin of a patient;   attaching an analyte sensor control unit to the skin of the patient and coupling a plurality of conductive contacts of the analyte sensor control unit to a plurality of contacts of the analyte sensor;   collecting data, using the analyte sensor control unit, regarding a level of an analyte from a signal generated by the analyte sensor; and   transmitting the collected data from the analyte sensor control unit to a receiver unit.   
     
     
         80 . The method of  claim 79 , wherein the analyte is glucose. 
     
     
         81 . The method of  claim 79 , wherein the collecting data comprises generating signals from the analyte sensor and processing the signals into data. 
     
     
         82 . The method of  claim 79 , wherein the data comprise the signals from the analyte sensor. 
     
     
         83 . The method of  claim 79 , further comprising activating an alarm if the data indicate an alarm condition. 
     
     
         84 . The method of  claim 79 , further comprising administering a drug in response to the data. 
     
     
         85 . The method of  claim 84 , wherein the drug is insulin. 
     
     
         86 . The method of  claim 79 , further comprising obtaining a calibration value from a calibration device to calibrate the data. 
     
     
         87 . The method of  claim 86 , wherein the calibration device is coupled to a display unit. 
     
     
         88 . The method of  claim 87 , further comprising transmitting the calibration value from a transmitter in the display unit to a receiver in the analyte sensor control unit.