Analyte Sensor, and Associated System and Method Employing a Catalytic Agent

Abstract

An analyte sensor for use in connection with a biofluid is described. The analyte sensor may comprise any suitable interface between the biofluid and a derivative of the biofluid and any suitable transducer of information concerning an analyte. At least one catalytic agent is provided in a locale or vicinity of the interface. The catalytic agent, such as a proteinaceous agent or a non-proteinaceous, organic-metal agent, is sufficient to catalyze the degradation of reactive oxygen and/or nitrogen species that may be present in the vicinity of the interface. An analyte-sensing kit and a method of sensing an analyte are also described.

1 . An analyte monitoring device, comprising a first electrode that functions as a working electrode, a second electrode that function as a counter electrode or a reference/counter electrode, and a substrate, wherein the electrodes and the substrate are positioned in a stacked configuration such that the electrodes are positioned substantially on top of each other with an insulator therebetween, and further, wherein at least a portion of the device is configured for positioning below a skin surface, the device further configured to generate an analyte related signal to communicate to an external device.  
     
     
         2 . The device of  claim 1  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 a wired enzyme.  
     
     
         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 6  wherein the membrane limits the transport of mass to the sensor.  
     
     
         8 . The device of  claim 1  wherein the first and the second electrodes respectively include carbon and silver/silver chloride.  
     
     
         9 . The device of  claim 1 , wherein the first electrode is positioned on the substrate, the insulator positioned on the first electrode, and the second electrode positioned on the insulator.  
     
     
         10 . The device of  claim 9  including a third electrode.  
     
     
         11 . The device of  claim 10 , wherein the third electrode is positioned on an insulator that is positioned on the second electrode.  
     
     
         12 . The device of  claim 10  wherein the third electrode is a reference electrode.  
     
     
         13 . The device of  claim 12 , wherein the insulator is positioned on the counter electrode.  
     
     
         12 . A transcutaneous sensor, comprising: 
 a first layer;    a first conducting layer functioning as a working electrode, 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 that functions as a counter electrode or a reference/counter electrode, at least a portion of which is positioned in contact with at least a portion of the second surface of the second layer, such that the first and second conducting layers are positioned in a stacked configuration with at least a portion of the second layer therebetween;    wherein at least a portion of the sensor is configured for positioning below a skin surface, the sensor further configured to generate an analyte related signal to communicate to an external device.    
     
     
         13 . The sensor of  claim 12  wherein the first and the second layers comprise nonconducting material.  
     
     
         14 . The sensor of  claim 12  comprising an analyte responsive enzyme.  
     
     
         15 . The device of  claim 14  wherein the enzyme is disposed on the device.  
     
     
         16 . The device of  claim 12  comprising a membrane.  
     
     
         17 . The device of  claim 16  wherein the membrane is formed in situ.  
     
     
         18 . The device of  claim 12  wherein at least another portion of the first conducting layer is in fluid contact with an analyte of a patient.  
     
     
         19 . A method, comprising: 
 providing a first electrode that functions as a working electrode;    providing a second electrode that function as a counter electrode or a reference/counter electrode;    providing a substrate;    positioning the first and second electrodes and the substrate in a stacked configuration such that the electrodes are positioned substantially on top of each other with an insulator therebetween;    positioning at least a portion of the device below a skin surface; and    generating an analyte related signal to communicate to an external device.    
     
     
         20  The method of  claim 19  further including providing an analyte responsive enzyme.