Biosensor, thin film electrode forming method, quantification apparatus, and quantification method

• US 8,480,878 B2
• Filed: 01/11/2011
• Issued: 07/09/2013
• Est. Priority Date: 11/15/1999
• Status: Expired due to Fees

• Current Assignee: PHC Holdings Corporation
• Original Assignee: Panasonic Corporation (Panasonic Holdings Corporation)
• Inventors: Miyazaki, Shoji, Tokunaga, Hiroyuki, Fujiwara, Masaki, Yamanishi, Eriko
• Primary Examiner(s): Noguerola, Alex
• Application Number:
  US12/930,627
• Publication Number:
  US 20110174613A1
• Time in Patent Office: 910 Days
• Field of Search: 20440301-40315, 205/77.5, 205/778, 205/792
• US Class Current: 205/792
• 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 33/48771 Coding of information, e.g. calibration data, lot number
• CPC Class Codes: Y10T 29/49002 Electrical device making

Abstract

A biosensor is disclosed comprising a support; a conductive layer composed of an electrical conductive material such as a noble metal, for example gold or palladium, and carbon; slits parallel to and perpendicular to the side of the support; working, counter, and detecting electrodes; a spacer which covers the working, counter, and detecting electrodes on the support; a rectangular cutout in the spacer forming a specimen supply path; an inlet to the specimen supply path; a reagent layer formed by applying a reagent containing an enzyme to the working, counter, and detecting electrodes, which are exposed through the cutout in the spacer; and a cover over the spacer. The biosensor can be formed by a simple method, and provides a uniform reagent layer on the electrodes regardless of the reagent composition.

Claims

1. A biosensor for quantifying a substrate in a sample liquid comprising:

an insulating support;

a working electrode formed from an electrically conductive layer that is made of a noble metal and is provided on a surface of the insulating support;

a reagent layer on the working electrode;

a spacer layer provided on and covering part of the reagent layer, where the spacer layer defines a supply path for bringing the sample liquid into contact with the reagent layer and where the supply path formed by the spacer layer is narrower than the reagent layer; and

a cover provided on the spacer layer, where the cover comprises a counter electrode formed from an electrically conductive layer that is made of a noble metal and is provided on an inner surface of the cover;

wherein a portion of the counter electrode and a portion of the working electrode are in the supply path, and

wherein part of the reagent layer is in the supply path.

2. The biosensor of claim 1, wherein the spacer layer forms a vertical wall of the supply path.

3. The biosensor of claim 1, wherein the noble metal is palladium, platinum, gold, ruthenium, or a combination thereof.

4. The biosensor of claim 1, wherein the electrodes have a thickness from 3 nm to 1000 nm.

5. The biosensor of claim 1, wherein the electrodes have a thickness from 3 nm to 100 nm.

6. The biosensor of claim 1, wherein the electrodes have a thickness from 3 nm to 50 nm.

7. The biosensor of claim 1, wherein the electrodes have a wettability index equal to or greater than 48 dyn/cm.

8. The biosensor of claim 1, wherein the working electrode and the counter electrode are separated by 0.005 mm to 0.3 mm.

9. The biosensor of claim 1, wherein a portion of the counter electrode is closer than the working electrode to an inlet of the supply path.

10. The biosensor of claim 1, wherein the biosensor comprises a detecting electrode formed from the electrically conductive layer that is made of noble metal and provided on a surface of the insulating support.

11. The biosensor of claim 10, wherein a portion of the detecting electrode is in the supply path.

12. The biosensor of claim 1, wherein the reagent layer comprises an enzyme and an electron transfer agent.

13. The biosensor of claim 12, wherein the reagent layer comprises a hydrophilic polymer.

14. The biosensor of claim 1, wherein the biosensor comprises an air hole that leads to the supply path.

15. The biosensor of claim 1, wherein the working electrode is located within the supply path.

16. The biosensor of claim 1, comprising a correcting unit that stores correction data generated for each production lot of the biosensor, which data correspond to characteristics of the biosensor and can be read by a measuring device employing the biosensor.

17. The biosensor of claim 1, wherein the portion of the counter electrode in the supply path is equal to or larger than the portion of the working electrode in the supply path.

18. The biosensor of claim 1, wherein the noble metal is gold.

19. A biosensor for quantifying a substrate in a sample liquid comprising:

an insulating support;

an electrically conductive layer that is made of a noble metal and is provided on a surface of the insulating support;

an electrode pattern comprising at least a working electrode and a counter electrode, where the electrode pattern is formed from the electrically conductive layer;

a slit provided on the electrically conductive layer between the working electrode and the counter electrode, where the slit has a depth that is equal to or greater than the thickness of the electrically conductive layer;

a reagent layer on the electrode pattern;

a spacer layer provided on and covering part of the reagent layer, where the spacer layer defines a supply path for bringing the sample liquid into contact with the reagent layer and where the supply path formed by the spacer layer is narrower than the reagent layer; and

a cover provided on the spacer layer;

wherein a portion of the counter electrode and a portion of the working electrode are in the supply path, and

wherein part of the reagent layer is in the supply path.

20. The biosensor of claim 19, wherein the slit is laser-formed.

21. The biosensor of claim 19, wherein the spacer layer forms a vertical wall of the supply path.

22. The biosensor of claim 19, wherein the noble metal is palladium, platinum, gold, ruthenium, or a combination thereof.

23. The biosensor of claim 19, wherein the electrode pattern has a thickness from 3 nm to 1000 nm.

24. The biosensor of claim 19, wherein the electrode pattern has a thickness from 3 nm to 100 nm.

25. The biosensor of claim 19, wherein the electrode pattern has a thickness from 3 nm to 50 nm.

26. The biosensor of claim 19, wherein the electrode pattern has a wettability index equal to or greater than 48 dyn/cm.

27. The biosensor of claim 19, wherein the working electrode and the counter electrode are separated by 0.005 mm to 0.3 mm.

28. The biosensor of claim 19, wherein the a portion of counter electrode is closer than the working electrode to an inlet of the supply path.

29. The biosensor of claim 19, wherein the electrode pattern comprises a detecting electrode.

30. The biosensor of claim 29, wherein a portion of the detecting electrode is in the supply path.

31. The biosensor of claim 19, wherein the reagent layer comprises an enzyme and an electron transfer agent.

32. The biosensor of claim 31, wherein the reagent layer comprises a hydrophilic polymer.

33. The biosensor of claim 19, wherein the biosensor comprises an air hole that leads to the supply path.

34. The biosensor of claim 19, wherein the working electrode is located within the supply path.

35. The biosensor of claim 34, wherein the working electrode is surrounded by the counter electrode.

36. The biosensor of claim 19, comprising a correcting unit that stores correction data generated for each production lot of the biosensor, which data correspond to characteristics of the biosensor and can be read by a measuring device employing the biosensor.

37. The biosensor of claim 19, wherein the portion of the counter electrode in the supply path is equal to or larger than the portion of the working electrode in the supply path.

38. The biosensor of claim 19, wherein the noble metal is gold.