BIOSENSOR AND METHOD OF MAKING

• US 20090056120A1
• Filed: 09/25/2008
• Published: 03/05/2009
• Est. Priority Date: 10/04/1999
• Status: Active Grant

• Current Assignee: Roche Diabetes Care Inc. (Roche Holding AG)
• Original Assignee: Roche Operations Limited (Roche Holding AG)
• Inventors: Diebold, Eric R., Hill, Brian S., Bhullar, Raghbir S., Walling, Paul Douglas, Surridge, Nigel
• Granted Patent: US 8,551,308 B2
• Time in Patent Office: Days
• US Class Current: 29/847
• 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: G01N 33/5438 Electrodes
• CPC Class Codes: H05K 1/0393 Flexible materials H05K1/038 takes precedence; specific organic compositions are classified in H05K1/0313 and subgroups
• CPC Class Codes: H05K 3/027 the conductive material being removed by irradiation, e.g. by photons, alpha or beta particles
• CPC Class Codes: Y10T 29/49117 Conductor or circuit manufacturing
• CPC Class Codes: Y10T 29/49155 Manufacturing circuit on or in base
• CPC Class Codes: Y10T 29/49156 with selective destruction of conductive paths

Abstract

An electrochemical biosensor with electrode elements that possess smooth, high-quality edges. These smooth edges define gaps between electrodes, electrode traces and contact pads. Due to the remarkable edge smoothness achieved with the present invention, the gaps can be quite small, which provides marked advantages in terms of test accuracy, speed and the number of different functionalities that can be packed into a single biosensor. Further, the present invention provides a novel biosensor production method in which entire electrode patterns for the inventive biosensors can be formed all at one, in nanoseconds—without regard to the complexity of the electrode patterns or the amount of conductive material that must be ablated to form them.

Claims

1. A method of manufacturing a plurality of biosensors, comprising:

(a) providing a web of base substrate material having a metal conductive layer formed thereon;

(b) projecting an image of an electrode pattern onto the metal conductive layer with a laser apparatus, wherein an electrode pattern that corresponds to the image is formed by laser ablation on the web of base substrate material;

(c) moving one of the laser apparatus and the web of base substrate material and repeating step (b) a plurality of times to produce a plurality of the electrode patterns at spaced intervals along the web of base substrate material;

(d) depositing a reagent on the web of base substrate material and at least partially covering each electrode pattern of the plurality of electrode patterns with the reagent;

(e) laminating at least one web of a covering layer or a spacing layer over the web of base substrate material, thereby forming a cover and a sample-receiving chamber for each biosensor; and

(f) cutting through the at least one web of a covering layer or a spacing layer and the web of base substrate material to form the plurality of biosensors.

2. The method of claim 1, wherein the electrode pattern formed in step (b) comprises a complete electrode pattern for one of the biosensors, whereby the complete electrode pattern for each biosensor is formed in a single step.

3. The method of claim 1, wherein the electrode pattern formed in step (b) comprises a partial electrode pattern, the image comprises a plurality of the same or different images, and steps (b) and (c) are repeated until the plurality of electrode patterns comprises a plurality of complete electrode patterns, whereby each complete electrode pattern is formed in multiple steps.

4. The method of claim 1, wherein step (c) comprises continuously moving the web of base substrate material.

5. The method of claim 1, wherein step (c) comprises moving the web of base substrate material in discrete increments.

6. The method of claim 1, wherein step (c) comprises moving the web of base substrate material at a rate of at least 10 meters per minute.

7. The method of claim 1, wherein the electrode pattern includes at least two electrode sets having different feature sizes.

8. The method of claim 1, wherein the electrode pattern comprises first and second electrodes having first and second respective edges defining a gap therebetween, the gap having a width and a length, the first edge being spaced from a first theoretical line by a first distance that varies along the length of the gap, the first theoretical line defining a desired shape and placement of the first edge, wherein the standard deviation of the first distance is less than about 6 μ

m over the entire length of the gap.

9. The method of claim 8, wherein the standard deviation is less than about 2 μ

m.

10. The method of claim 8, wherein the standard deviation is less than about 1 μ

m.

11. The method of claim 1, wherein the metal conductive layer comprises at least one member selected form the group consisting of gold, platinum, palladium and iridium.

12. The method of claim 1, wherein step (e) comprises:

laminating the spacing layer over the base substrate material, the spacing layer having a void that defines the perimeter of the chamber; and

laminating the covering layer over the spacing layer.

13. The method of claim 1, wherein each electrode pattern formed in step (b) is formed in less than 1 second.

14. The method of claim 1, wherein each electrode pattern formed in step (b) is formed in less than 0.25 second.

15. The method of claim 1, wherein each electrode pattern formed in step (b) is formed all at once.

16. The method of claim 1, wherein each electrode pattern formed in step (b) comprises the entire electrode pattern for one of the biosensors and each entire electrode pattern is formed all at once.

17. The method of claim 1, wherein the reagent is applied in a substantially continuous stripe.

18. The method of claim 1, wherein the electrode pattern is anisotropic.

19. The method of claim 1, wherein the electrode pattern is asymmetric.

20. The method of claim 1, wherein the electrode pattern formed in step (b) comprises a complete electrode pattern for one of the biosensors, whereby the complete electrode pattern for each biosensor is formed in a single step, the method further comprising forming the complete electrical patterns at a rate of at least 100 per minute.

21. The method of claim 20, wherein forming the electrode patterns comprises removing at least 20% of the metal conductive layer.

22. The method of claim 20, wherein forming the electrode patterns comprises removing at least 50% of the metal conductive layer.

23. The method of claim 20, wherein forming the electrode patterns comprises removing at least 90% of the metal conductive layer.

24. The method of claim 1, wherein the electrode pattern formed in step (b) comprises a complete electrode pattern for one of the biosensors, whereby the complete electrode pattern for each biosensor is formed in a single step, the method further comprising forming the complete electrical patterns at a rate of at least 1000 per minute.

25. The method of claim 24, wherein forming the electrode patterns comprises removing at least 20% of the metal conductive layer.

26. The method of claim 24, wherein forming the electrode patterns comprises removing at least 50% of the metal conductive layer.

27. The method of claim 24, wherein forming the electrode patterns comprises removing at least 90% of the metal conductive layer.

28. The method of claim 1, wherein the electrode pattern formed in step (b) comprises a complete electrode pattern for one of the biosensors, whereby the complete electrode pattern for each biosensor is formed in a single step, the method further comprising forming the complete electrical patterns at a rate of at least 2000 per minute.

29. The method of claim 28, wherein forming the electrode patterns comprises removing at least 20% of the metal conductive layer.

30. The method of claim 28, wherein forming the electrode patterns comprises removing at least 50% of the metal conductive layer.

31. The method of claim 28, wherein forming the electrode patterns comprises removing at least 90% of the metal conductive layer.

32. The method of claim 1, wherein the electrode pattern formed in step (b) comprises a complete electrode pattern for one of the biosensors, whereby the complete electrode pattern for each biosensor is formed in a single step, the method further comprising forming the complete electrical patterns at a rate of at least 3000 per minute.

33. The method of claim 32, wherein forming the electrode patterns comprises removing at least 20% of the metal conductive layer.

34. The method of claim 32, wherein forming the electrode patterns comprises removing at least 50% of the metal conductive layer.

35. The method of claim 32, wherein forming the electrode patterns comprises removing at least 90% of the metal conductive layer.