Methods of manufacturing a light guide test sensor

• US 8,383,414 B2
• Filed: 07/01/2005
• Issued: 02/26/2013
• Est. Priority Date: 07/02/2004
• Status: Active Grant

• Current Assignee: Ascensia Diabetes Care Holdings AG (PHC Holdings Corporation)
• Original Assignee: Bayer Healthcare LLC (Bayer AG)
• Inventors: Reynolds, Jeffery S., Charlton, Steven C., Jung, Sung-Kwon, George, Suny J.
• Primary Examiner(s): WHITE, DENNIS MICHAEL
• Application Number:
  US11/629,955
• Publication Number:
  US 20080064939A1
• Time in Patent Office: 2,797 Days
• Field of Search: 422/56, 422/82.11, 422/400, 422/401, 422/408, 422/420, 422/421, 422/422, 422/423, 422/424, 422/425, 422/426, 422/427, 422/428, 422/429, 422/68.1, 422/82.05, 422/82.06, 422/82.07, 422/82.08, 422/82.09, 436/169, 436/170, 436/164, 435/13, 435/283.1, 435/287.1, 435/287.7, 435/287.8, 435/287.9, 435/288.7
• US Class Current: 436/169
• CPC Class Codes: G01N 2021/772 Tip coated light guide
• CPC Class Codes: G01N 2021/7773 Reflection
• CPC Class Codes: G01N 21/251 Colorimeters; Construction thereof
• CPC Class Codes: G01N 21/474 Details of optical heads therefor, e.g. using optical fibres
• CPC Class Codes: G01N 21/64 Fluorescence; Phosphorescence
• CPC Class Codes: G01N 21/6486 Measuring fluorescence of biological material, e.g. DNA, RNA, cells G01N21/6428 takes precedence
• CPC Class Codes: G01N 21/7703 using reagent-clad optical fibres or optical waveguides using measurement of total internal reflection or attenuated total reflection G01N21/552; optical fibres or waveguides per se G02B
• CPC Class Codes: G01N 21/78 producing a change of colour
• CPC Class Codes: G01N 21/80 Indicating pH value
• CPC Class Codes: G01N 2201/08 Optical fibres; light guides
• CPC Class Codes: G01N 33/582 with fluorescent label
• CPC Class Codes: G01N 33/583 with non-fluorescent dye label
• CPC Class Codes: Y10T 156/1313 Cutting element simultaneously bonds [e.g., cut seaming]
• CPC Class Codes: Y10T 436/144444 Glucose

Abstract

An optic light guide test sensor comprises a light guide, a reagent-coated membrane, and a mesh layer. The reagent-coated membrane and the mesh layer are attached to the light guide at an output end of the light guide. The light guide test sensor is adapted to be used to test the level of an analyte in a biological fluid sample when used with a readhead. A method of manufacturing the light guide test sensor involves providing a plurality of light guides, providing a strip of reagent-coated membrane, and providing a strip of mesh layer. The reagent-coated membrane and mesh layer are attached to the light guides by ultrasonic welding. The reagent-coated membrane and mesh layer may also be attached to the light guides by adhesive.

Claims

1. A method of manufacturing a light guide test sensor, the method comprising the acts of:

providing a plurality of light guides having a respective adhesive member attached to one end, each of the plurality of light guides configured to guide and deliver illuminating light to a fluid sample, and guide and deliver reflected light from the fluid sample, each of the plurality of light guides having structure to contain light being delivered to and from the fluid sample;

providing a strip of reagent-coated membrane, the reagent being adapted to react with a fluid sample to indicate information relating to an analyte in a sample;

contacting the membrane strip to the plurality of light guides by the adhesive member; and

attaching and cutting the membrane strip to the plurality of light guides using a punch to cut the membrane strip and using the light guides as a die, wherein the membrane strip is attached to the plurality of light guides by the adhesive member.

2. The method of claim 1, wherein the adhesive member is double-sided tape.

3. The method of claim 1 further included providing a strip of mesh layer and attaching the mesh layer strip to the membrane strip.

4. The method of claim 3 wherein the mesh layer strip is attached to the membrane strip using an adhesive.

5. The method of claim 1 wherein the cutting and attaching take place at about the same time.

6. The method of claim 1 wherein the membrane strip is a porous polymeric membrane.

7. The method of claim 1 wherein the light guide is a waveguide with a transparent core with a reflective index cladding applied thereto.

8. The method of claim 1 wherein the light guide is a hollow waveguide with absorbing layers.

9. The method of claim 1 wherein the light guide is a hollow waveguide with reflecting layers.

10. The method of claim 1 wherein the light guide includes optical fibers.

11. The method of claim 1 wherein the membrane strip includes a fluorescent assay.

12. The method of claim 1 wherein the membrane strip includes a phosphorescent assay.

13. The method of claim 1 wherein the light guide further includes a light trap.

14. A method of manufacturing a light guide test sensor, the method comprising the acts of:

providing a plurality of light guides having a respective adhesive member attached to one end, each of the light guides being a waveguide or a plurality of optical fibers;

providing a strip of reagent-coated membrane, the reagent being adapted to react with a fluid sample to indicate information relating to an analyte in a sample;

contacting the membrane strip to the plurality of light guides by the adhesive member; and

attaching and cutting the membrane strip to the plurality of light guides using a punch to cut the membrane strip and using the light guides as a die, wherein the membrane strip is attached to the plurality of light guides by the adhesive member.

15. The method of claim 14, wherein the adhesive member is double-sided tape.

16. The method of claim 14 further included providing a strip of mesh layer and attaching the mesh layer strip to the membrane strip.

17. The method of claim 14 wherein the cutting and attaching take place at about the same time.

18. The method of claim 14 wherein the light guide is a waveguide with a transparent core with a reflective index cladding applied thereto.

19. The method of claim 14 wherein the light guide is a hollow waveguide with absorbing layers.

20. The method of claim 14 wherein the light guide is a hollow waveguide with reflecting layers.

21. The method of claim 14 wherein the light guide includes optical fibers.

22. The method of claim 14 wherein the membrane strip includes a fluorescent assay.

23. The method of claim 14 wherein the membrane strip includes a phosphorescent assay.

24. The method of claim 14 wherein the light guide further includes a light trap.

25. A method of manufacturing a light guide test sensor, the method comprising the acts of:

providing a plurality of light guides having a respective adhesive member attached to one end, each of the light guides including a structure in which light is guided by total internal reflection;

providing a strip of reagent-coated membrane, the reagent being adapted to react with a fluid sample to indicate information relating to an analyte in a sample;

contacting the membrane strip to the plurality of light guides by the adhesive member; and

attaching and cutting the membrane strip to the plurality of light guides using a punch to cut the membrane strip and using the light guides as a die, wherein the membrane strip is attached to the plurality of light guides by the adhesive member.