Light guide test sensor

• US 8,940,237 B2
• Filed: 01/22/2013
• Issued: 01/27/2015
• 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:
  US13/746,471
• Publication Number:
  US 20130177993A1
• Time in Patent Office: 735 Days
• Field of Search: 422/400, 422/401, 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, 422/82.11, 436/164, 436/169, 436/170, 435/13, 435/283.1, 435/287.1, 435/287.7, 435/287.8, 435/287.9, 435/288.7
• US Class Current: 422/82.11
• 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. An optic light guide test sensor comprising:

a light guide having an input end and an output end;

a reagent-coated membrane being located at the output end of the light guide and being attached to the light guide, the reagent being adapted to react with a fluid sample to indicate the level of an analyte in the sample; and

a mesh layer being attached to the membrane, the mesh layer having pore sizes from about 10 micrometer (0.01 mm) to about 200 micrometer (0.2 mm),

wherein the light guide further includes protrusions located at the output end, the protrusions being made of a meltable material and assisting in attaching the reagent-coated membrane and the mesh layer to the output end of the light guide.

2. An optic light guide test sensor comprising:

a light guide having an input end and an output end,

a reagent-coated membrane, the reagent being adapted to react with a fluid sample to indicate the level of an analyte in the sample; and

a mesh layer being attached to the reagent membrane,

wherein the light guide includes protrusions located at the output end, the protrusions being made of a meltable material and assisting in attaching the reagent-coated membrane and the mesh layer to the output end of the light guide.

3. The optic light guide test sensor of claim 2, wherein the mesh layer assists in spreading the fluid sample over the surface of the membrane, the mesh layer including a wetting agent.

4. The optic light guide test sensor of claim 2 wherein the reagent-coated membrane includes a fluorescent or phosphorescent assay.

5. The optic light guide test sensor of claim 2, wherein the light guide is an illumination light guide and further includes a detection light guide having an input end and an output end, the detection light guide input end being in close proximity to the illumination light guide output end;

and wherein the reagent-coated membrane is attached to the illumination light guide and the detection light guide, the reagent-coated membrane being illuminated by a light from the output end of the illumination light guide.

6. The optic light guide test sensor of claim 2 further comprising a light trap that absorbs a specular component of the light from the output end of the illumination light guide, the light trap being located within the light guide.

7. The optic light guide test sensor of claim 2, wherein the illumination light guide cross section shape is a polygon with an even number of congruent sides, and the detection light guide cross section shape is a polygon with an even number of congruent sides.

8. The optic light guide test sensor of claim 7, wherein the illumination light guide cross section shape is square, and the detection light guide cross section shape is square.

9. An optic light guide test sensor comprising:

a light guide having an input end and an output end; and

a reagent-coated membrane, the reagent being adapted to react with a fluid sample to indicate the level of an analyte in the sample,

wherein the light guide includes protrusions located at the output end, the protrusions being made of a meltable material to assist in attaching to the reagent-coated membrane to an output end of the light guide.

10. The optic light guide test sensor of claim 9 further comprising a mesh layer being attached to the reagent-coated membrane, the mesh layer assisting in spreading the fluid sample over the surface of the membrane, the mesh layer having pore sizes from about 10 micrometer (0.01 mm) to about 200 micrometer (0.2 mm).

11. The optic light guide test sensor of claim 9 further comprising a mesh layer being attached to the reagent membrane.