Light Guide Test Sensor

• US 20130177993A1
• Filed: 01/22/2013
• Published: 07/11/2013
• 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.
• Granted Patent: US 8,940,237 B2
• Time in Patent Office: Days
• US Class Current: 436/95
• 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

1-14. -14. (canceled)

15. 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).

16. The optic light guide test sensor of claim 15, 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.

17. The optic light guide test sensor of claim 15, wherein the mesh layer assists in spreading the fluid sample over the surface of the reagent-coated membrane, the mesh layer including a wetting agent.

18. The optic light guide test sensor of claim 15, wherein the reagent-coated membrane includes a fluorescent or phosphorescent assay.

19. The optic light guide test sensor of claim 15, 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.

20. The optic light guide test sensor of claim 19 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.

21. The optic light guide test sensor of claim 19, 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.

22. The optic light guide test sensor of claim 21, wherein the illumination light guide cross section shape is square, and the detection light guide cross section shape is square.

23. The optic light guide test sensor of claim 15, wherein the light guide is a waveguide with a transparent core with a reflective index cladding applied thereto.

24. The optic light guide test sensor of claim 15, wherein the light guide is a hollow waveguide with absorbing layers.

25. The optic light guide test sensor of claim 15, wherein the light guide is a hollow waveguide with reflecting layers.

26. The optic light guide test sensor of claim 15 wherein the light guide includes optical fibers.

27. 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.

28. The optic light guide test sensor of claim 27, wherein the mesh layer assists in spreading the fluid sample over the surface of the membrane, the mesh layer including a wetting agent.

29. The optic light guide test sensor of claim 27 wherein the reagent-coated membrane includes a fluorescent or phosphorescent assay.

30. The optic light guide test sensor of claim 27, 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.

31. The optic light guide test sensor of claim 27 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.

32. The optic light guide test sensor of claim 27, 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.

33. The optic light guide test sensor of claim 32, wherein the illumination light guide cross section shape is square, and the detection light guide cross section shape is square.

34. 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.

35. The optic light guide test sensor of claim 34 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).

36. The optic light guide test sensor of claim 34 further comprising a mesh layer being attached to the reagent membrane.

37. A method of testing the level of an analyte in a fluid, the method comprising the acts of:

providing a light guide test sensor, the light guide sensor having a light guide, a reagent-coated membrane and a mesh layer, the mesh layer having pore sizes from about 10 micrometer (0.01 mm) to about 200 micrometer (0.2 mm);

providing a readhead that is adapted to operate in conjunction with the light guide test sensor to test the level of the analyte in the fluid;

lancing an area of the body to produce a sample of the fluid;

collecting the fluid sample with the reagent-coated membrane and mesh layer of the light guide test sensor;

contacting the light guide test sensor with the collected sample so that the readhead is in position to test the fluid sample;

measuring the light reflected from the sample; and

determining the level of the analyte in the fluid using the measured light reflected from the sample.

38. The method of claim 37, wherein the analyte is glucose.

39. The method of claim 37, wherein the fluid sample is less than 70 nanoliters.

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

providing a plurality of light guides having a first end and a second end, the plurality of light guides having protrusions at the first end;

providing a strip of reagent-coated membrane;

placing the reagent-coated membrane strip onto the plurality of light guides so that the light guide protrusions at the first end thereof are in contact with the reagent-coated membrane strip; and

attaching and cutting the reagent-coated membrane strip to the plurality of light guides using ultrasonic welding to melt the protrusions and bond the reagent-coated membrane strip to the plurality of light guides, and wherein the light guide is used as a die for the attaching and cutting.

41. The method of claim 40 further including:

providing a strip of mesh layer;

placing the reagent-coated membrane strip and the mesh strip onto the plurality of light guides, the reagent-coated membrane strip being in direct contact with the mesh strip; and

attaching and cutting the membrane strip and the mesh strip to the plurality of light guides using ultrasonic welding to melt the protrusions and bond the membrane strip and the mesh strip to the plurality of light guides.

42. The method of claim 40 further including

providing a strip of mesh layer;

and

placing the mesh layer strip onto the reagent-coated membrane strip, the mesh layer strip being in direct contact with the reagent-coated membrane strip, the mesh layer strip having pore sizes from about 10 micrometer (0.01 mm) to about 200 micrometer (0.2 mm).

43. The method of claim 40 further including

providing a strip of mesh layer;

and

placing the mesh layer strip onto the reagent-coated membrane strip, the mesh layer strip being in direct contact with the reagent-coated membrane strip, the mesh layer strip including a wetting agent.