Test sensor and method for manufacturing the same

• US 8,153,081 B2
• Filed: 05/14/2004
• Issued: 04/10/2012
• 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.
• Primary Examiner(s): Shibuya, Mark
• Assistant Examiner(s): Crawford, Erik B
• Application Number:
  US10/845,026
• Publication Number:
  US 20040241881A1
• Time in Patent Office: 2,888 Days
• Field of Search: 156/250, 156/251, 156/230, 156/232, 422/58, 422/60, 422/56, 422/57, 422/68.1, 422/401, 422/420, 422/425, 435/4, 435/287.1, 435/287.7, 435/287.8, 435/287.9, 435/288.7
• US Class Current: 422/420
• 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 test sensor for use in the determination of an analyte in a liquid sample, the test sensor comprising:

a base defining a bottom wall and a plurality of side walls of a capillary channel and a reaction area formed in a surface of the base, the capillary channel adapted to move a liquid sample from an inlet to the reaction area;

a carrier having a first surface directly attached to the surface of the base, the carrier being disposed over at least a portion of the capillary channel; and

a test membrane adhered to the first surface of the carrier such that the test membrane does not contact the bottom wall and the plurality of side walls of the capillary channel and the reaction area defined by the base, the test membrane containing a reagent, the test membrane extending from the carrier into the reaction area.

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

3. The test sensor of claim 1 wherein the test membrane is generally disk-shaped.

4. The test sensor of claim 1 wherein the carrier is constructed of a substantially hydrophobic material.

5. The test sensor of claim 1 wherein the carrier is constructed of a substantially optically clear material.

6. The test sensor of claim 1 wherein the test membrane is adhered to the lower surface of the carrier with a substantially optically clear adhesive.

7. The test sensor of claim 1 wherein the test membrane is constructed of a polyethersulfone material.

8. The test sensor of claim 1 wherein the capillary channel has an inlet end and an opposite end, the opposite end being uncovered by the carrier.

18. The test sensor of claim 1 wherein the lower surface of the carrier is directly attached to the surface of the base with an adhesive.

20. The test sensor of claim 1, wherein the carrier is a polymer carrier.

22. The test sensor of claim 1, wherein the sensor is an optical sensor.

23. The test sensor of claim 1, wherein the sensor is an electrochemical sensor.

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

a base defining a bottom wall and a plurality of side walls of a capillary channel and a reaction area formed in a surface of the base, the reaction area having a depth formed in the base, the capillary channel adapted to move a liquid sample from an inlet to the reaction area;

a carrier having a first surface directly attached to the surface of the base, the carrier being disposed over at least a portion of the capillary channel; and

a test membrane adhered to the first surface of the carrier, the test membrane containing a reagent, the test membrane extending from the carrier into the reaction area and having a thickness less than the depth of the reaction area such that the test membrane does not contact the base and a first space is provided between a lower surface of the test membrane and a bottom of the reaction area,

wherein a transverse dimension of the test membrane is less than a transverse dimension of the reaction area such that a second space is provided between an edge of the test membrane and an edge of the reaction area.

10. The test sensor of claim 9, wherein the capillary channel has an inlet end and an opposite end, the opposite end being uncovered by the carrier.

11. The test sensor of claim 9, wherein the reagent is adapted to produce a colorimetric reaction indicative of the concentration of the analyte in the sample.

12. The test sensor of claim 9, 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 9, wherein the lower surface of the carrier is directly attached to the surface of the base with an adhesive.

21. The test sensor of claim 9, wherein the carrier is a polymer carrier.

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

a base defining a bottom wall and a plurality of side walls of a capillary channel and a reaction area formed in a surface of the base, the capillary channel adapted to move a liquid sample from an inlet to the reaction area;

a polymer carrier having a first surface directly attached to the surface of the base, the polymer carrier being disposed over at least a portion of the capillary channel and being constructed of a substantially hydrophobic material; and

a generally disk-shaped test membrane adhered to the first surface of the polymer carrier such that the test membrane does not contact the bottom wall and the plurality of side walls of the capillary channel and the reaction area defined by the base, 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 carrier is constructed of a substantially optically clear material.

15. The test sensor of claim 13, wherein the generally disk-shaped test membrane is adhered to the lower surface of the carrier with a substantially optically clear adhesive.

16. The test sensor of claim 13, wherein the generally disk-shaped test membrane is constructed of a polyethersulfone material.

17. 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.