Method Of Making A Multi-Layer Pad For Use In Determining An Analyte Concentration

Abstract

A multi-layer pad that is adapted to be used in determining an analyte concentration is disclosed. The multi-layer pad includes a first layer, a second layer, and a third layer. The first layer includes an enzyme wherein the enzyme is adapted to assist in determining the analyte concentration. The second layer is attached to a first surface of the first layer. The second layer is made of a skin-conforming material. The third layer is attached to a second surface of the first layer wherein the first layer is located between the second layer and the third layer. It is contemplated that the multi-layer pad may also be a two layer system.

1 . A multi-layer pad adapted to be used in determining an analyte concentration, the pad comprising:
 a first layer including an enzyme, the enzyme being adapted to assist in determining the analyte concentration; and   a second layer being attached to the first layer, the second layer being made of a skin-conforming material.   
     
     
         2 . The pad of  claim 1 , wherein the skin-conforming material comprises a hydrogel. 
     
     
         3 . The pad of  claim 1 , wherein the skin-conforming material is a cross-linked hydrophillic polymer. 
     
     
         4 . The pad of  claim 1 , wherein the second layer includes permeation enhancers, humectants, surfactants, or combinations thereof. 
     
     
         5 . The pad of  claim 1 , wherein the first layer further includes fabric, porous membrane, or paper material. 
     
     
         6 . The pad of  claim 5 , wherein the enzyme is physically absorbed on or in the fabric, porous membrane, or paper material. 
     
     
         7 . The pad of  claim 5 , wherein the enzyme is chemically immobilized in the fabric, porous membrane, or paper material. 
     
     
         8 . The pad of  claim 1 , wherein the enzyme is glucose oxidase. 
     
     
         9 . The pad of  claim 1 , wherein the enzyme is glucose dehydrogenase. 
     
     
         10 . A multi-layer pad adapted to be used in determining an analyte concentration, the pad comprising:
 a first layer including an enzyme, the enzyme being adapted to assist in determining the analyte concentration;   a second layer being made of a skin-conforming material; and   a third layer in which the first layer is located between the second layer and third layer.   
     
     
         11 . The pad of  claim 10 , wherein the skin-conforming material comprises a hydrogel. 
     
     
         12 . The pad of  claim 10 , wherein the skin-conforming material is a cross-linked hydrophillic polymer. 
     
     
         13 . The pad of  claim 10 , wherein the second layer includes permeation enhancers, humectants, surfactants or combinations thereof. 
     
     
         14 . The pad of  claim 10 , wherein the first layer further includes fabric, porous membrane, or paper material. 
     
     
         15 . The pad of  claim 14 , wherein the enzyme is physically absorbed on or in the fabric, porous membrane, or paper material. 
     
     
         16 . The pad of  claim 14 , wherein the enzyme is chemically immobilized in the fabric, porous membrane, or paper material. 
     
     
         17 . The pad of  claim 10 , wherein the enzyme is glucose oxidase. 
     
     
         18 . The pad of  claim 10 , wherein the enzyme is glucose dehydrogenase. 
     
     
         19 . A method of continuously determining an analyte concentration, the method comprising the acts of:
 is providing a multi-layer pad comprising a first layer and a second layer, the second layer being attached to the first layer, the first layer including an enzyme, the enzyme being adapted to assist in determining the analyte concentration, the second layer being made of a skin-conforming material;   providing a sensor that is adapted to assist in determining the analyte concentration;   placing the multi-layer pad on the skin, the multi-layer pad being located between the sensor and the skin; and   determining the analyte concentration.   
     
     
         20 . The method of  claim 19 , wherein the skin is the volar forearm. 
     
     
         21 . The method of  claim 19 , wherein the analyte is glucose. 
     
     
         22 . The method of  claim 19 , wherein the sensor is an electrochemical sensor. 
     
     
         23 . The method of  claim 19 , wherein the skin-conforming material comprises a hydrogel. 
     
     
         24 . The method of  claim 19 , wherein the skin-conforming material is a cross-linked hydrophillic polymer. 
     
     
         25 . The method of  claim 19 , wherein the second layer includes permeation enhancers, humectants, surfactants, or combinations thereof. 
     
     
         26 . The method of  claim 19 , wherein the first layer further includes fabric, porous membrane, or paper material. 
     
     
         27 . The method of  claim 19 , wherein the enzyme is glucose oxidase. 
     
     
         28 . The method of  claim 19 , wherein the enzyme is glucose dehydrogenase. 
     
     
         29 . A method of continuously determining an analyte concentration, the method comprising the acts of:
 providing a multi-layer pad comprising a first layer, a second layer, and a third layer, the second layer being made of a skin-conforming material, the first layer including an enzyme, the enzyme being adapted to assist in determining the analyte concentration, the first layer being located between the second layer and the third layer;   providing a sensor that is adapted to assist in determining the analyte concentration;   is placing the multi-layer pad on the skin, the multi-layer pad being located between the sensor and the skin; and   determining the analyte concentration.   
     
     
         30 . The method of  claim 29 , wherein the skin-conforming material comprises a hydrogel. 
     
     
         31 . The method of  claim 29 , wherein the skin-conforming material is a cross-linked hydrophillic polymer. 
     
     
         32 . The method of  claim 29 , wherein the second layer includes permeation enhancers, humectants, surfactants, or combinations thereof. 
     
     
         33 . The method of  claim 29 , wherein the first layer further includes fabric, porous membrane, or paper material. 
     
     
         34 . The method of  claim 29 , wherein the enzyme is glucose oxidase. 
     
     
         35 . The method of  claim 29 , wherein the enzyme is glucose dehydrogenase. 
     
     
         36 . An electrochemical sensor system comprising:
 an electrochemical sensor having a least a counter electrode and a working electrode;   a multi-layer pad coupled to the electrochemical sensor, the multi-layer pad comprising a first layer and a second layer, the second layer being attached to the first layer, the second layer being biocompatible for skin contact, the first layer including an enzyme, the enzyme being adapted to assist in determining the analyte concentration.   
     
     
         37 . The sensor system of  claim 36 , wherein the multi-layer pad is attached to the electrochemical sensor. 
     
     
         38 . The sensor system of  claim 36 , wherein the multi-layer pad is attached to the electrochemical sensor via an adhesive. 
     
     
         39 . The sensor system of  claim 36 , wherein the sensor further includes a third electrode.