Biosensor Membranes Composed of Polymers Containing Heterocyclic Nitrogens

Abstract

Novel membranes comprising various polymers containing heterocyclic nitrogen groups are described. These membranes are usefully employed in electrochemical sensors, such as amperometric biosensors. More particularly, these membranes effectively regulate a flux of analyte to a measurement electrode in an electrochemical sensor, thereby improving the functioning of the electrochemical sensor over a significant range of analyte concentrations. Electrochemical sensors equipped wish such membranes are also described.

1 . An analyte monitoring device having a stacked configuration, the device comprising a first electrode, a second electrode, and a substrate, wherein the first and second electrodes, and the substrate are positioned in a stacked configuration, wherein at least a portion of the device is configured for positioning below a skin surface, and further, wherein a sensing layer is disposed on at least a portion of one of the first or second electrodes.  
     
     
         2 . The device of  claim 1  further comprising an analyte responsive enzyme.  
     
     
         3 . The device of  claim 2  wherein the enzyme is a glucose responsive enzyme  
     
     
         4 . The device of  claim 2  wherein the enzyme is disposed on the device.  
     
     
         5 . The device of  claim 1  comprising a membrane.  
     
     
         6 . The device of  claim 5  wherein the membrane is formed in situ.  
     
     
         7 . The device of  claim 5  wherein the membrane is a mass transport limiting membrane  
     
     
         8 . The device of  claim 1  wherein the device includes a transcutaneous sensor.  
     
     
         9 . The device of  claim 1  wherein each of the first and the second electrodes comprise one of a working electrode, and a reference electrode or a reference/counter electrode.  
     
     
         10 . The device of  claim 1  further including a third electrode.  
     
     
         11 . The device of  claim 10  wherein the first electrode, the second electrode and the third electrode comprise a working electrode, a reference electrode, and a counter electrode.  
     
     
         12 . The device of  claim 10  wherein at least two of the first electrode, the second electrode and the third electrode comprise a first working electrode and a second working electrode.  
     
     
         13 . The device of  claim 1  wherein at least a portion of the device is connectable to a unit for monitoring one or more signals from the device.  
     
     
         14 . A transcutaneous sensor, comprising: 
 a first layer;    a first conducting layer at least a portion of which is positioned in contact with at least a first portion of the first layer;    a second layer having a first surface and a second surface, at least a portion of the first surface positioned in contact with at least a first portion of the first conducting layer; and    a second conducting layer at least a portion of which is positioned in contact with at least a portion of the second surface of the second layer; 
 wherein a sensing layer is disposed over at least a portion of one of the first conducting layer or the second conducting layer.  
   
     
     
         15 . The sensor of  claim 14  wherein the first and the second layers comprise nonconducting material.  
     
     
         16 . The sensor of  claim 14  wherein at least one of the first conducting layer and the second conducting layer includes a working electrode.  
     
     
         17 . The sensor of  claim 14  wherein the second layer is substantially disposed between the first conducting layer and the second conducting layer.  
     
     
         18 . The sensor of  claim 14  comprising an analyte responsive enzyme.  
     
     
         19 . The sensor of  claim 18  wherein the enzyme is disposed on the device.  
     
     
         20 . The sensor of  claim 14  comprising a membrane.  
     
     
         21 . The sensor of  claim 20  wherein the membrane is a mass transport limiting layer  
     
     
         22 . The sensor of  claim 20  wherein the membrane is formed in situ.  
     
     
         23 . The sensor of  claim 14  wherein at least another portion of the first conducting layer is in fluid contact with an analyte of a patient.  
     
     
         24 . The sensor of  claim 14 , wherein at least a portion of the device is connectable to a unit for monitoring one or more signals from the device.