Apparatus and method of manufacturing bodily fluid test strip
View Patent ↗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, said sensor port having a maximum dimension;
providing a sheet or ribbon of test strip material;
drawing said sheet or ribbon of test strip material through a reagent bath;
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;
applying said test element to said dry test strip holder in a location covering said sensor port; and
engaging a cap with a test element well to hold said test strip element in the location, wherein said test element well is part of the dry test strip, 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; and
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.
2. The method of claim 1 wherein the test strips are capable of being used with a photometer through which reflectance is photometrically sensed through said sensor port to determine the characteristic of the bodily fluid.
3. A method as in claim 1 wherein:
said test element well is located above said sensor port, and a flexible retainer encircles 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.
4. A method as in claim 3 wherein said inserter is cone-shaped.
5. 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.
6. A method as in claim 1 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.
7. A method as in claim 1 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.
8. A method as in claim 1 wherein no glue is used to hold said test element in said location.
9. A method as in claim 1 wherein said sensor port is configured to receive a photometric device.
10. A method as in claim 1 wherein said cap and said test element well hold said test strip element with a compressive force.
11. A method as in claim 10 wherein glue is not used to hold the test strip element.
12. A method as in claim 1 wherein the cutting and applying is performed by a single apparatus.