Apparatus and method of manufacturing bodily fluid test strip

• US 8,307,531 B2
• Filed: 05/03/2010
• Issued: 11/13/2012
• Est. Priority Date: 08/17/2004
• Status: Expired due to Fees

• Current Assignee: Polymer Technology Systems Incorporated (Sinocare, Inc.)
• Original Assignee: Polymer Technology Systems Incorporated (Sinocare, Inc.)
• Inventors: Lawrence, Gregory M.
• Primary Examiner(s): Bryant, David
• Assistant Examiner(s): Koehler, Christopher
• Application Number:
  US12/772,707
• Publication Number:
  US 20100205797A1
• Time in Patent Office: 925 Days
• Field of Search: 294/58, 295/271, 298/966, 422/400, 422/401, 422/407, 422/421, 422/426, 422/430, 435/4, 435/11, 435/287.1, 435/287.8, 435/287.9, 723/33, 723/38, 83/55
• 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. 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.