Test sensor and method for manufacturing the same

• US 8,506,903 B2
• Filed: 03/09/2012
• Issued: 08/13/2013
• 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): Brown, Melanie Y
• Assistant Examiner(s): Crawford, Erik B
• Application Number:
  US13/416,611
• Publication Number:
  US 20120230874A1
• Time in Patent Office: 522 Days
• Field of Search: 422/26, 422/60, 435/4, 435/7.1, 435/286.5, 435/287.8, 435/287.9, 435/288.5, 435/288.7, 436/514
• US Class Current: 422/421
• 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 determining an analyte concentration in a liquid sample, the method comprising:

providing from a first roll a polymer carrier strip having a first surface;

attaching a test membrane obtained from a second roll directly to the first surface of the carrier strip;

impregnating the test membrane with a reagent after the test membrane is attached to the first surface of the carrier strip;

providing a base having a second surface with a capillary channel and reaction area formed therein, the reaction area including a bottom and side walls; and

adhering the first surface of the carrier strip directly to the second surface of the base over at least a portion of the reaction area such that the test membrane extends into the reaction area formed in second surface of the base without contacting the bottom and side walls of the reaction area.

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

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

removing the excess membrane material.

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

4. The method of claim 1, wherein attaching comprises:

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

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

crush-cutting an individual test membrane section from the length of the test membrane material;

adhering the individual test membrane section to the polymer carrier strip; and

removing the excess membrane material and adhesive liner.

5. The method of claim 1, wherein attaching comprises adhering the test membrane to the surface of the polymer carrier strip with a substantially optically clear adhesive.

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

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

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

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

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

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

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

13. The method of claim 1, wherein providing the polymer carrier strip comprises providing a substantially optically clear polymer carrier strip.

14. The method of claim 1, wherein the polymer carrier strip is constructed of a substantially hydrophobic material.