APPARATUS AND METHOD OF MANUFACTURING BODILY FLUID TEST STRIP

• US 20100205797A1
• Filed: 05/03/2010
• Published: 08/19/2010
• Est. Priority Date: 08/17/2004
• Status: Active Grant

• Current Assignee: Polymer Technology Systems Incorporated (Sinocare, Inc.)
• Original Assignee: Polymer Technology Systems Incorporated (Sinocare, Inc.)
• Inventors: Lawrence, Gregory M.
• Granted Patent: US 8,307,531 B2
• Time in Patent Office: Days
• US Class Current: 29/458
• CPC Class Codes: G01N 33/52 Use of compounds or compositions for colorimetric, spectrophotometric or fluorometric investigation, e.g. use of reagent paper and including single- and multilayer analytical elements immunological elements G01N33/54386; involving labelled immunochemicals G01N33/58; for haemoglobin or occult blood G01N33/72
• CPC Class Codes: G01N 33/525 Multi-layer analytical elements
• CPC Class Codes: Y10T 29/49885 with coating before or during assembling
• CPC Class Codes: Y10T 29/4998 Combined manufacture including applying or shaping of fluent material
• CPC Class Codes: Y10T 83/06 Blanking

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.

Claims

1-20. -20. (canceled)

21. 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.

22. The method of claim 21 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.

23. A method as in claim 21 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.

24. A method as in claim 23 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.

25. A method as in claim 24 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.

26. A method as in claim 25 wherein said inserter is cone-shaped.

27. A method as in claim 21 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.

28. A method as in claim 21 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.

29. A method as in claim 21 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.

30. A method as in claim 21 wherein no glue is used to hold said test element in said location.

31. A method as in claim 21 wherein said sensor port is configured to receive a photometric device.

32. A method as in claim 21 wherein said cap and said test element well hold said test strip element with a compressive force.

33. A method as in claim 32 wherein glue is not used to hold the test strip element.

34. A method as in claim 21 wherein the cutting and applying is performed by a single apparatus.

35. 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, 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; and

engaging a cap with a test element well to hold a periphery of said test strip element in the location, wherein said test element well is part of the dry test strip.

36. A method as in claim 35 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.

37. A method as in claim 35 wherein said cutting comprises cutting a test element having a maximum dimension that is 15% or less larger than said sensor port maximum dimension.

38. A method as in claim 35 wherein said sensor port is configured to receive a photometric device.

39. A method as in claim 35 wherein the cutting and applying is performed by a single apparatus.

40. 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, 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; and

engaging a cap with a test element well to hold a periphery of said test strip element in the location, wherein said test element well is part of the dry test strip, wherein the cutting, applying, and engaging are performed by a single apparatus.