Method of Manufacturing a Diagnostic Test Strip

Abstract

A method for manufacturing a biosensor is provided. The method may include positioning a shadow mask containing a pattern of a plurality of feature sets over a substantially planar base layer containing a plurality of registration points. The method may also include forming at least one of the plurality of feature sets on the substantially planar base layer by selectively depositing a layer of a conductive material on the substantially planar base layer by passing the conductive material through the pattern of the shadow mask and removing the shadow mask from the substantially planar base layer. Alternatively, the method may include providing a laminate structure including a substantially planar base layer containing a plurality of registration points and a photoresist layer containing a pattern of a plurality of feature sets. The method may further include forming at least one of the plurality of feature sets on the substantially planar base layer by selectively depositing a layer of a conductive material on the substantially planar base layer by passing the conductive material through the pattern of the photoresist layer and removing the photoresist layer from the substantially planar base layer.

1 . A method for manufacturing a biosensor, comprising:
 positioning a shadow mask containing a pattern of a plurality of feature sets over a substantially planar base layer containing a plurality of registration points;   forming at least one of the plurality of feature sets on the substantially planar base layer by selectively depositing a layer of a conductive material on the substantially planar base layer by passing the conductive material through the pattern of the shadow mask; and   removing the shadow mask from the substantially planar base layer.   
     
     
         2 . The method of  claim 1 , wherein the shadow mask includes at least one of molybdenum, aluminum, nickel, silicon, and a polymer. 
     
     
         3 . The method of  claim 2 , wherein the polymer includes polyethylene terephthalate. 
     
     
         4 . The method of  claim 1 , wherein at least one of the plurality of feature sets includes at least one of a working electrode, a counter electrode, a fill-detect electrode, an auto-on conductor, and a coding region. 
     
     
         5 . The method of  claim 1 , wherein the plurality of registration points are formed by at least one of laser ablation, etching, drilling, printing, punching, scoring, heating, compression, and molding. 
     
     
         6 . The method of  claim 1 , wherein the plurality of feature sets formed on the substantially planar base layer are separated by less than 10 mm. 
     
     
         7 . The method of  claim 1 , wherein the plurality of registration points are separated by less than 500 mm. 
     
     
         8 . The method of  claim 1 , wherein the plurality of feature sets formed on the substantially planar base layer are formed at a density greater than one per 400 mm 2 . 
     
     
         9 . The method of  claim 1 , wherein the plurality of feature sets formed on the substantially planar base layer are formed at a density greater than a density of the plurality of registration points on the substantially planar base layer. 
     
     
         10 . The method of  claim 1 , wherein at least one of the plurality of feature sets is less than 40 mm in length. 
     
     
         11 . The method of  claim 1 , wherein at least one of the plurality of registration points is less than 10 mm wide. 
     
     
         12 . The method of  claim 1 , wherein positioning the shadow mask over the substantially planar base layer further includes using an adhesive material to at least partially maintain the position of the shadow mask over the substantially planar base layer. 
     
     
         13 . The method of  claim 12 , wherein the adhesive material includes at least one of a pressure sensitive adhesive and a heat activated adhesive. 
     
     
         14 . The method of  claim 1 , wherein depositing the layer of the conductive material includes at least one of physical vapor deposition, electroplating, ultrasonic spraying, and pressure spraying. 
     
     
         15 . The method of  claim 14 , wherein physical vapor deposition includes at least one of sputtering and evaporation. 
     
     
         16 . The method of  claim 1 , wherein the conductive material includes at least one material selected from the group consisting of palladium, gold, platinum, silver, iridium, carbon, indium tin oxide, indium zinc oxide, copper, aluminum, gallium, iron, mercury amalgams, tantalum, titanium, zirconium, nickel, osmium, rhenium, rhodium palladium, an organometallic, and a metallic alloy. 
     
     
         17 . The method of  claim 1 , wherein the method further includes depositing a bonding layer on the substantially planar base layer before depositing the conductive material on the substantially planar base layer. 
     
     
         18 . The method of  claim 17 , wherein the bonding layer includes at least one of titanium and chromium. 
     
     
         19 . The method of  claim 1 , wherein the method further includes depositing a reagent layer to contact a portion of the plurality of feature sets. 
     
     
         20 . The method of  claim 19 , wherein the reagent layer further includes at least one of glucose oxidase, glucose dehydrogenase, potassium ferricyanide, and ruthenium hexamine. 
     
     
         21 - 39 . (canceled) 
     
     
         40 . A biosensor, comprising:
 a substantially planar base layer; and   a plurality of conductive components formed on the substantially planar base layer, wherein at least one of the plurality of conductive components includes a wall feature.   
     
     
         41 . The biosensor of  claim 40 , wherein the plurality of conductive components includes at least one of a working electrode, a counter electrode, a fill-detect anode, a fill-detect cathode, an auto-on conductor, and a coding region. 
     
     
         42 . The biosensor of  claim 40 , wherein the plurality of conductive components includes at least one material selected from the group consisting of gold, platinum, silver, iridium, carbon, indium tin oxide, indium zinc oxide, copper, aluminum, gallium, iron, mercury amalgams, tantalum, titanium, zirconium, nickel, osmium, rhenium, rhodium, palladium, an organometallic, and a metallic alloy. 
     
     
         43 . The biosensor of  claim 40 , wherein the plurality of conductive components are separated by less than 10 mm. 
     
     
         44 . The biosensor of  claim 40 , wherein the plurality of conductive components formed on the substantially planar base layer are formed by at least one of physical vapor deposition, electroplating, ultrasonic spraying and pressure spraying. 
     
     
         45 . The biosensor of  claim 44 , wherein physical vapor deposition includes at least one of sputtering and evaporation. 
     
     
         46 . The biosensor of  claim 40 , wherein the wall feature includes as least one of an intrusion and a protrusion. 
     
     
         47 . The biosensor of  claim 40 , wherein the wall feature is formed using at least one of lift-off lithography and a shadow mask. 
     
     
         48 . The biosensor of  claim 40 , wherein the biosensor further includes a reagent layer to contact a portion of the plurality of conductive components. 
     
     
         49 . The biosensor of  claim 48 , wherein the reagent layer further includes at least one of glucose oxidase, glucose dehydrogenase, potassium ferricyanide, and ruthenium hexamine. 
     
     
         50 . The biosensor of  claim 40 , wherein the biosensor further includes a bonding layer between the substantially planar base layer and at least one of the plurality of conductive components. 
     
     
         51 . The biosensor of  claim 50 , wherein the bonding layer includes at least one of titanium and chromium. 
     
     
         52 . The biosensor of  claim 40 , wherein at least one of the plurality of conductive components is less than 40 mm in length. 
     
     
         53 . A reel, comprising:
 a substantially planar base layer;   a plurality of registration points formed on the substantially planar base layer; and   a plurality of conductive components formed on the substantially planar base layer, wherein at least one of the plurality of conductive components includes a wall feature.   
     
     
         54 . The reel of  claim 53 , wherein the plurality of conductive components includes at least one of a working electrode, a counter electrode, a fill-detect anode, a fill-detect cathode, an auto-on conductor, and a coding region. 
     
     
         55 . The reel of  claim 53 , wherein the plurality of conductive components includes at least one material selected from the group consisting of gold, platinum, silver, iridium, carbon, indium tin oxide, indium zinc oxide, copper, aluminum, gallium, iron, mercury amalgams, tantalum, titanium, zirconium, nickel, osmium, rhenium, rhodium, palladium, an organometallic, and a metallic alloy. 
     
     
         56 . The reel of  claim 53 , wherein the plurality of conductive components are separated by less than 10 mm. 
     
     
         57 . The reel of  claim 53 , wherein the plurality of conductive components formed on the substantially planar base layer are formed by at least one of physical vapor deposition, electroplating, ultrasonic spraying and pressure spraying. 
     
     
         58 . The reel of  claim 57 , wherein physical vapor deposition includes at least one of sputtering and evaporation. 
     
     
         59 . The reel of  claim 53 , wherein the wall feature includes as least one of an intrusion and a protrusion. 
     
     
         60 . The reel of  claim 53 , wherein the wall feature is formed using at least one of lift-off lithography and a shadow mask. 
     
     
         61 . The reel of  claim 53 , wherein the reel further includes a bonding layer between the substantially planar base layer and at least one of the plurality of conductive components. 
     
     
         62 . The reel of  claim 61 , wherein the bonding layer includes at least one of titanium and chromium. 
     
     
         63 . The reel of  claim 53 , wherein the biosensor further includes a reagent layer to contact a portion of the plurality of conductive components. 
     
     
         64 . The reel of  claim 63 , wherein the reagent layer further includes at least one of glucose oxidase, glucose dehydrogenase, potassium ferricyanide, and ruthenium hexamine. 
     
     
         65 . The reel of  claim 53 , wherein the plurality of registration points are formed by at least one of laser ablation, etching, drilling, printing, punching, scoring, heating, compression and molding. 
     
     
         66 . The reel of  claim 53 , wherein the plurality of registration points are separated by less than 500 mm. 
     
     
         67 . The reel of  claim 53 , wherein the plurality of conductive components formed on the substantially planar base layer are formed at a density greater than a density of the plurality of registration points formed on the substantially planar base layer. 
     
     
         68 . The reel of  claim 53 , wherein at least one of the plurality of conductive components is less than 40 mm in length. 
     
     
         69 . The reel of  claim 53 , wherein at least one of the plurality of registration points is less than 10 mm wide.