Apparatus and method of manufacturing bodily fluid test strip

Abstract

There is a dry test strip holder having a test port and a retainer defining a well about the test port, and a sheet of test strip material. A test element that is 50% or less greater than the size of the test port is cut from the sheet using a die and punch. The punch drives the test element through a channel in the die while the cone-shaped outer surface of the die spreads the retainer, allowing the test element to drop into the well. A cap is snapped over the retainer to capture the test element.

1 . A method of manufacturing a dry test strip for determining a characteristic of a bodily fluid, said method comprising: 
 providing a dry test strip holder having a sensor port;    providing a sheet or ribbon of test strip material;    cutting a test element from said test strip material; and thereafter applying said test element to said dry test strip holder in a location covering said sensor port.    
     
     
         2 . A method as in  claim 1  wherein said cutting comprises engaging said sheet or ribbon with a die.  
     
     
         3 . A method as in  claim 1  wherein said cutting comprises: 
 providing a die and a punch;    locating said sheet or ribbon between said die and said punch; and    driving said punch against said sheet or ribbon and into said die.    
     
     
         4 . A method as in  claim 3  wherein said providing comprises providing said die having a channel through it, and said applying comprises: 
 locating said die above said strip holder with said channel above said sensor port; and    using said punch to push said cut test element through and out of said die channel.    
     
     
         5 . A method as in  claim 4  wherein said dry test strip holder includes a test element well located above said sensor port and a flexible retainer encircling said test element well; said providing further comprises providing an inserter having a ramped surface, said ramped surface located about the periphery of said channel; and said applying further comprises pressing said ramped surface of said inserter against said retainer to bend it in a direction away from said sensor port and inserting said cut test element into said well.  
     
     
         6 . A method as in  claim 5  and further comprising engaging said retainer with a cap to capture said cut test element in said well.  
     
     
         7 . A method as in  claim 1  wherein said test holder further includes a test element well located above said sensor port and said applying comprises placing said cut test element in said test element well.  
     
     
         8 . A method as in  claim 7  wherein said dry test strip holder further includes a cap and said method further comprises capping said test element well with said cap.  
     
     
         9 . A method as in  claim 1  wherein said cutting comprises cutting a circular test element.  
     
     
         10 . A method as in  claim 9  wherein said cutting comprises cutting a rectangular test element.  
     
     
         11 . A method as in  claim 9  wherein said providing a dry test strip holder comprises providing a dry test strip holder having a sensor port, said sensor port having a maximum dimension, and said cutting comprises cutting a test element having a maximum dimension that is 50% or less of said sensor port maximum dimension.  
     
     
         12 . A method as in  claim 11  wherein said cutting comprises cutting a test element having a maximum dimension that is 75% or more of the width of said sheet or ribbon,  
     
     
         13 . A method as in  claim 11  wherein said cutting comprises cutting a test element having a maximum dimension that is 90% or more of the width of said sheet or ribbon.  
     
     
         14 . A method of manufacturing a dry test strip for determining a characteristic of a bodily fluid, said method comprising: 
 providing a dry test strip holder having a sensor port; said sensor port having a maximum dimension;    providing a sheet or ribbon of test strip material;    cutting a test element from said test strip material, said test element having a maximum dimension that is 50% or less larger than said sensor port maximum dimension; and    applying said test element to said dry test strip holder in a location covering said sensor port.    
     
     
         15 . A method as in  claim 14  wherein said cutting comprises cutting a test strip element having a maximum dimension that is 30% or less larger than said sensor port maximum dimension.  
     
     
         16 . A method as in  claim 14  wherein said cutting comprises cutting a test element having a maximum dimension that is 15% or less larger than said sensor port maximum dimension.  
     
     
         17 . A machine for manufacturing a dry test strip, said machine comprising: 
 a die having a cutting edge substantially shaped in the form of the outer perimeter of a dry test strip element and a channel extending away from said cutting edge;    a punch shaped to snugly and slidably fit in said channel; and    a support for holding a sheet or ribbon of dry test material between said punch and said die.    
     
     
         18 . A machine as in  claim 17  and further comprising an inserter having a ramped surface formed about the periphery of said channel and extending away from the distal end of said channel.  
     
     
         19 . A machine as in  claim 18  wherein said inserter is cone-shaped.  
     
     
         20 . A machine as in  claim 17  and further comprising a dry test strip material drive for moving said sheet or ribbon between said punch and said die.