Method of forming a multilayer test sensor

• US 8,083,884 B2
• Filed: 12/21/2006
• Issued: 12/27/2011
• Est. Priority Date: 12/27/2005
• Status: Active Grant

• Current Assignee: Ascensia Diabetes Care Holdings AG (PHC Holdings Corporation)
• Original Assignee: Bayer Healthcare LLC (Bayer AG)
• Inventors: Edelbrock, Andrew J.
• Primary Examiner(s): Osele, Mark A
• Assistant Examiner(s): Caillouet, Christopher C
• Application Number:
  US12/086,240
• Publication Number:
  US 20090159197A1
• Time in Patent Office: 1,832 Days
• Field of Search: 156/250, 156/252, 156/253, 156/256, 204/403.3, 204/403.12, 204/403.14
• US Class Current: 156/257
• CPC Class Codes: B23K 2101/18 Sheet panels
• CPC Class Codes: B23K 2101/20 Tools
• CPC Class Codes: B23K 26/38 by boring or cutting
• CPC Class Codes: C12Q 1/001 Enzyme electrodes
• 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: Y10T 156/1052 with cutting, punching, tearing or severing
• CPC Class Codes: Y10T 156/1056 Perforating lamina
• CPC Class Codes: Y10T 156/1057 Subsequent to assembly of laminae
• CPC Class Codes: Y10T 156/1062 Prior to assembly
• CPC Class Codes: Y10T 156/1064 Partial cutting [e.g., grooving or incising]

Abstract

A method of forming an electrochemical multilayer test sensor that includes a base, a second layer and a reactive layer. The reactive area includes an enzyme. The test sensor is adapted to be used in a meter and assist in determining the concentration of an analyte. A plurality of electrodes and their respective conductive leads are partially defined on the base. After partially defining the plurality of electrodes and their respective conductive leads on the base, the base is attached to a second layer to define a reaction zone in which the plurality of electrodes are fully defined. After attaching the base to the second layer, the plurality of conductive leads on the base of the test sensor are fully defined.

Claims

1. A method of forming an electrochemical multilayer test sensor, the multilayer test sensor including a base, a second layer and a reactive area, the reactive area including an enzyme, the test sensor being adapted to be used in a meter and assist in determining the concentration of an analyte, the method comprising the acts of:

partially defining a plurality of electrodes and their respective conductive leads on the base;

after partially defining the plurality of electrodes and their respective conductive leads on the base, attaching the base to a second layer to define a reaction zone in which the plurality of electrodes are fully defined, thereby leaving a portion of the base uncovered by the second layer; and

after attaching the base to the second layer, further processing to define the plurality of conductive leads on the portion of the base which is uncovered by the second layer.

2. The method of claim 1, wherein the plurality of conductive leads and plurality of electrodes are defined by a laser.

3. The method of claim 1, wherein the plurality of conductive leads and plurality of electrodes are defined by printing, coating, vapor deposition, sputtering or electrochemical deposition.

4. The method of claim 1, wherein the act of partially defining the plurality of electrodes includes using a laser.

5. The method of claim 1, wherein the second layer is a lid.

6. The method of claim 1, wherein the second layer is a spacer.

7. The method of claim 1, wherein the second layer forms a plurality of guides.

8. The method of claim 1, further including excising the multi-layer test sensor from the attached base and the second layer.

9. The method of claim 8, wherein the act of excising the multi-layer test sensor from the attached base and the second layer includes using a mechanical punch.

10. The method of claim 8, wherein the act of excising the multiple-test sensor and the act of defining the plurality of conductive traces are registered with each other.

11. The method of claim 1, wherein the base and the second layer are attached using an adhesive.

12. The method of claim 1, wherein the plurality of electrodes comprises a metallic conductive material.

13. The method of claim 1, wherein the enzyme is glucose oxidase or glucose dehydrogenase.

14. A method of forming an electrochemical multilayer test sensor, the multilayer test sensor including a base, a second layer and a reactive area, the reactive area including an enzyme, the test sensor being adapted to be used in a meter and assist in determining the concentration of an analyte, the method comprising the acts of:

partially defining a plurality of electrodes and their respective conductive leads on the base via a laser;

after partially defining the plurality of electrodes and their respective conductive leads on the base, attaching the base to a second layer to define a reaction zone in which the plurality of electrodes are fully defined, thereby leaving a portion of the base uncovered by the second layer;

after attaching the base to the second layer, further processing to define the plurality of conductive leads on the portion of the base which is uncovered by the second layer; and

excising the test sensor from the attached base and the second layer.

15. The method of claim 14, wherein the second layer is a lid.

16. The method of claim 14, wherein the second layer is a spacer.

17. The method of claim 14, wherein the act of excising the multi-layer test sensor from the attached base and the second layer includes using a mechanical punch.

18. The method of claim 14, wherein the act of excising the multiple-test sensor and the act of defining the plurality of conductive traces are registered with each other.

19. The method of claim 14, wherein the base and the second layer are attached using an adhesive.

20. The method of claim 14, wherein the enzyme is glucose oxidase or glucose dehydrogenase.