Test sensor and method for manufacturing the same

• US 20040241881A1
• Filed: 05/14/2004
• Published: 12/02/2004
• Est. Priority Date: 05/29/2003
• Status: Active Grant

• Current Assignee: Ascensia Diabetes Care Holdings AG (PHC Holdings Corporation)
• Original Assignee: Bayer Healthcare LLC (Bayer AG)
• Inventors: Kuriger, Rex J.
• Granted Patent: US 8,153,081 B2
• Time in Patent Office: Days
• US Class Current: 436/518
• CPC Class Codes: A61B 5/14532 for measuring glucose, e.g. by tissue impedance measurement
• CPC Class Codes: A61B 5/1455 using optical sensors, e.g. spectral photometrical oximeters
• CPC Class Codes: B01L 3/5027 by integrated microfluidic structures, i.e. dimensions of channels and chambers are such that surface tension forces are important, e.g. lab-on-a-chip B01L3/5023 takes precedence; micromixers B01F33/30; microreactors for synthesis B01J19/0093; microcapillary devices in general B81B1/00
• CPC Class Codes: B01L 3/502707 characterised by the manufacture of the container or its components by shaping or joining plastic parts B29C59/00, B29C65/00; by laminating B32B37/00; manufacture of microstructural devices in general B81C
• CPC Class Codes: G01N 21/78 producing a change of colour
• CPC Class Codes: G01N 27/3272 Test elements therefor, i.e. disposable laminated substrates with electrodes, reagent and channels optical biosensors G01N33/52
• CPC Class Codes: G01N 33/525 Multi-layer analytical elements
• CPC Class Codes: Y10T 156/1052 with cutting, punching, tearing or severing
• CPC Class Codes: Y10T 156/1054 and simultaneously bonding [e.g., cut-seaming]

Abstract

According to one embodiment of the present invention, an optical-based test sensor for use in the determination of an analyte in a liquid sample is disclosed. The test sensor includes a base, a polymer carrier, and a test membrane. The base has a capillary channel formed in a surface of the base that is adapted to move a liquid sample from an inlet to a reaction area formed in the base. The polymer carrier has a lower surface adhered to the surface of the base and is disposed over at least a portion of the capillary channel. The test membrane, which contains a reagent, is adhered to the lower surface of the polymer carrier and extends from the polymer carrier into the reaction area.

Claims

1. A method for manufacturing a test sensor for use in the determination of an analyte in a liquid sample, the method comprising:

providing a substantially hydrophobic polymer carrier having a surface;

adhering a test membrane to the surface of the polymer carrier, the test membrane adapted to absorb a reagent;

impregnating the test membrane with a reagent;

providing a base having a capillary channel formed therein; and

adhering the surface of the carrier to the base, wherein the test membrane extends into the capillary channel formed in base.

2. The method of claim 1 wherein impregnating comprises dipping the polymer carrier having the test membrane adhered thereto into a volume of the reagent.

3. The method of claim 1 wherein impregnating comprising pumping the reagent onto test membrane adhered to the surface of the polymer carrier.

4. The method of claim 1 wherein adhering comprises adhering a length of test membrane material to the polymer carrier, the method further comprising:

cutting a plurality of individual test membrane sections from the length of material; and

removing the excess membrane material.

5. The method of claim 4 wherein cutting comprises crush-cutting.

6. The method of claim 1 wherein the reagent is adapted to produce a colorimetric reaction indicative of the concentration of the analyte in the sample.

7. The method of claim 1 wherein the test membrane is generally disk-shaped.

8. The method of claim 1 wherein adhering comprises:

disposing a length of an adhesive liner on a length of the polymer carrier;

disposing a length of test membrane material on the length of adhesive liner;

crush-cutting a plurality of individual test membrane sections from the length of the test membrane material;

adhering the plurality of individual test membrane sections to the polymer carrier; and

removing the excess membrane material and adhesive liner.

9. The method of claim 1 wherein providing a polymer carrier comprises providing a substantially optically clear polymer carrier.

10. The method of claim 1 wherein adhering comprises adhering the test membrane to the surface of the carrier with a substantially optically clear adhesive.

11. The method of claim 1 further comprising forming one or more apertures in the polymer carrier.

12. The method of claim 1 wherein the test membrane is constructed of a polyethersulfone material.

13. An optical-based test sensor for use in the determination of an analyte in a liquid sample, the test sensor comprising:

a base having a capillary channel formed in a surface of the base, the capillary channel adapted to move a liquid sample from an inlet to a reaction area formed in the base;

a polymer carrier having a lower surface adhered to the surface of the base, the polymer carrier being disposed over at least a portion of the capillary channel; and

a test membrane adhered to the lower surface of the polymer carrier, the test membrane containing a reagent, the test membrane extending from the polymer carrier into the reaction area.

14. The test sensor of claim 13 wherein the reagent is adapted to produce a colorimetric reaction indicative of the concentration of the analyte in the sample.

15. The test sensor of claim 13 wherein the test membrane is generally disk-shaped.

16. The test sensor of claim 13 wherein the carrier is constructed of a substantially hydrophobic material.

17. The test sensor of claim 13 wherein the carrier is constructed of a substantially optically clear material.

18. The test sensor of claim 13 wherein the test membrane is adhered to the lower surface of the carrier with a substantially optically clear adhesive.

19. The test sensor of claim 13 wherein the test membrane has a thickness less than a depth of the reaction area such that a space is provided between a lower surface of the test membrane and a bottom of the reaction area.

20. The test sensor of claim 13 wherein a transverse dimension of the test membrane is less than a transverse dimension of the reaction area such that a space is provided between an edge of the test membrane and an edge of the reaction area.

21. The test sensor of claim 13 wherein the test membrane is constructed of a polyethersulfone material.

22. The test sensor of claim 13 wherein the capillary channel has an inlet end and an opposite end, the opposite end being uncovered by the carrier.