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

• US 7,998,325 B2
• Filed: 03/25/2004
• Issued: 08/16/2011
• Est. Priority Date: 11/15/1999
• Status: Active Grant

• Current Assignee: PHC Holdings Corporation
• Original Assignee: Panasonic Corporation (Panasonic Holdings Corporation)
• Inventors: Tokunaga, Hiroyuki, Tokuno, Yoshinobu, Yamanishi, Eriko, Fujiwara, Masaki, Miyazaki, Shoji
• Primary Examiner(s): NOGUEROLA, ALEXANDER STEPHAN
• Application Number:
  US10/809,217
• Publication Number:
  US 20040178066A1
• Time in Patent Office: 2,700 Days
• Field of Search: 20440301-40315, 205/777.5, 205/778, 205/792
• US Class Current: 204/403.04
• 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 included in a sample liquid comprising:

a first insulating support and a second insulating support;

an electrode part comprising at least a working electrode and a counter electrode;

a specimen supply path for introducing the sample liquid to the electrode part; and

a reagent layer employed for quantifying the substrate included in the sample liquid,

where the electrode part, the specimen supply path, and the reagent layer are situated between the first insulating support and the second insulating support,

the specimen supply path being provided on the electrode part, and the reagent layer being provided on the electrode part in the specimen supply path, respectively,

the electrode part being dividedly formed by a first type of slits provided on an electrical conductive layer which is formed on the whole or part of an internal surface of one or both of the first insulating support and the second insulating support,

the reagent layer is formed by dripping a reagent, and

a second type of slits is provided around a position where the reagent is dripped on the electrode part so as to partly surround the dripped position and be in contact with the reagent, said second type of slits restricting the spread of the reagent.

2. The biosensor as defined in claim 1, wherein the second type of slits is arc shaped.

3. The biosensor as defined in claim 1, wherein the electrode part further comprises a detecting electrode.

4. The biosensor as defined in claim 3, wherein the counter electrode is provided on the whole or part of the internal surface of the second insulating support,

the working electrode and the detecting electrode are provided on the whole or part of the internal surface of the first insulating support, and

the working electrode and the detecting electrode which are provided on the internal surface of the first insulating support are dividedly formed by the first type of slits provided on the electrical conductive layer.

5. The biosensor as defined in claim 3, wherein the counter electrode and the detecting electrode have a total area that is equal to or larger than that of the working electrode.

6. The biosensor as defined in claim 5, wherein the area of the detecting electrode in the specimen supply path of the biosensor is equal to the area of the counter electrode.

7. The biosensor as defined in claim 1, wherein the electrode part is provided on the whole or part of the internal surface of only the first insulating support, and the electrode part provided on the internal surface of the first insulating support is dividedly formed by the first type of slits provided on the electrical conductive layer.

8. The biosensor as defined in claim 1, wherein the counter electrode has an area equal to or larger than that of the working electrode.

9. The biosensor as defined in claim 1, wherein a spacer is provided which has a cutout part for forming the specimen supply path and is placed on the electrode part, and the second insulating support is placed on the spacer.

10. The biosensor as defined in claim 9, wherein the spacer and the second insulating support are integral.

11. The biosensor as defined in claim 1, wherein an air hole leading to the specimen supply path is formed.

12. The biosensor as defined in claim 1, wherein a third type of slits is provided for dividing the electrical conductive layer to define an area of the electrode part.

13. The biosensor as defined in claim 12, wherein the first insulating support and the second insulating support are approximately rectangular in shape, and one or more of the third type of slits are provided in parallel to one side of the approximate rectangle shape.

14. The biosensor as defined in claim 1 comprising information of correction data generated for each production lot of the biosensor, which correspond to characteristics concerning output of an electrical change resulting from a reaction between the sample liquid and the reagent layer and can be discriminated by a measuring device employing the biosensor.

15. The biosensor as defined in claim 14, wherein one or a plurality of a fourth type of slits dividing the electrode part are provided, and the measuring device can discriminate the information of the correction data according to positions of the fourth type of slits.

16. The biosensor as defined in claim 1, wherein at least one or all of the first type of slits, the second type of slits which are provided around a position where the reagent is dripped so as to form the reagent layer, the third type of slits which are provided for dividing the electrical conductive layer to define an area of the electrode part, and the fourth type of slits which divide the electrode part, are formed by processing the electrical conductive layer by a laser.

17. The biosensor as defined in claim 16, wherein the first type of slits, the second type of slits, the third type of slits, and the fourth type of slits have a slit width of 0.005 mm to 0.3 mm.

18. The biosensor as defined in claim 1, wherein the reagent layer comprises an enzyme.

19. The biosensor as defined in claim 1, wherein the reagent layer comprises an electron transfer agent.

20. The biosensor as defined in claim 1, wherein the reagent layer comprises a hydrophilic polymer.

21. The biosensor as defined in claim 1, wherein the insulating support is made of a resin material.