Biosensor

• US 6,503,381 B1
• Filed: 09/18/2000
• Issued: 01/07/2003
• Est. Priority Date: 09/12/1997
• Status: Expired due to Term

• Current Assignee: Abbott Diabetes Care Incorporated (Abbott Laboratories)
• Original Assignee: Therasense Incorporated (Abbott Laboratories)
• Inventors: Mure, Hiroki, Shirakawa, Hiroshi, Gotoh, Masao
• Primary Examiner(s): Tung, T.
• Assistant Examiner(s): NOGUEROLA, ALEXANDER STEPHAN
• Application Number:
  US09/664,319
• Time in Patent Office: 841 Days
• Field of Search: 204/403, 204/416, 204/403-1-4, 204/418, 204/419, 204/401
• US Class Current: 204/403.14
• CPC Class Codes: C12Q 1/005 involving specific analytes or enzymes including groups of enzymes, e.g. oxydases; C12Q1/004 takes precedence
• 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: Y10S 435/817 Enzyme or microbe electrode

Abstract

A biosensor comprises a space part for sucking and housing a sample formed of two upper and lower plates, the two plates being stuck together by an adhesive layer, the space part for sucking and housing the sample being constituted so as to be partially opened in the peripheral part and partially closed by the adhesive layer, and has a working electrode having at least glucose oxidase immobilized thereon and a counter electrode on the same plane of the plate.

Claims

1. A disposable glucose biosensor which is insertable and removable from a device body, said disposable glucose sensor comprising

an upper plate,

a lower plate,

a space formed between the two plates for housing a sample therein,

a layer for fixing the two plates together,

an opening for admitting the sample at a first end of the biosensor,

a working electrode,

a counter electrode fixed relative to the working electrode, the working electrode having oxidoreductase thereon,

the lower plate including an insulating base having the working and counter electrodes thereon, and

a sensor insertion signal terminal also formed thereon at an opposite end to the first end for interconnecting, upon insertion of the biosensor into the device body, two input terminals of the device body to allow power to flow between the two input terminals through the sensor insertion signal terminal and to the working electrode and said sensor insertion signal terminal being located with output terminal extensions of the working and counter electrodes also at said opposite end and being electrically insulated from the working and counter electrodes while being separated from the space for housing the sample.

2. The biosensor according to claim 1, further comprising an electron transmitter in a mixture layer with the oxidoreductase provided on the working electrode.

3. The biosensor according to claim 1, wherein the layer is an adhesive layer formed by a double-sided adhesive tape.

4. The biosensor according to claim 3, wherein a spacer with adhesive on both sides thereof is interposed between the two plates.

5. The biosensor according to claim 3, wherein a reference electrode is arranged at a side of one of the working electrode and the counter electrode.

6. The biosensor according to claim 3, wherein the layer is an adhesive layer having two surfaces and an adhesive on one of the two surfaces.

7. The biosensor according to claim 3, wherein the layer is an adhesive layer having two surfaces and an adhesive on both of the two surfaces.

8. The biosensor according to claim 3, wherein an insulating layer is formed between one of the two plates and the layer.

9. The biosensor according to claim 1, wherein said lower plate is rectangular.

10. The biosensor of claim 1, wherein the insertion judging electrode is formed in a rectangular shape.

11. The biosensor of claim 1, wherein the insertion judging electrode comprises the same material as the working electrode and the counter electrode.

12. The biosensor of claim 1, wherein the insulating base comprises a material selected from the group consisting of ceramics, glass, paper and plastic.

13. The biosensor of claim 1, wherein the insulating base comprises one of polyester and polyethylene terepthalate.

14. The biosensor of claim 1, wherein the counter electrode comprises a material selected from the group consisting of carbon, silver, gold and palladium.

15. The biosensor of claim 1, wherein the oxidoreductase is one of glucose oxidase and glucose dehydrogenase.

16. The biosensor of claim 1, wherein the insertion judging electrode comprises carbon.

17. The biosensor of claim 1, wherein the insertion judging electrode, the counter electrode and the working electrode each comprise carbon.

18. A biosensor which is insertable and removable from a device body, said biosensor comprising

an upper electrically insulating base,

a lower electrically insulating base,

a space formed between the two bases for housing a sample therein,

a layer for fixing the two bases together,

a sample opening at a peripheral part of a first end of the biosensor,

a working electrode and a counter electrode, the working electrode having oxidoreductase and a mediator thereon, and

a sensor insertion signal terminal at an opposite end to the first end for interconnecting, upon insertion of the biosensor into the device body, two input terminals of the device body to allow power to flow between the two input terminals through the sensor insertion signal terminal and to the working electrode and said sensor insertion signal terminal being located with output terminal extensions of the working and counter electrodes also at said opposite end wherein the working and counter electrodes, and the sensor insertion signal terminal, comprise carbon and are formed in a mutually electrically insulated state while the sensor insertion signal terminal is separated from the space for housing the sample.

19. The biosensor of claim 18, wherein the oxidoreductase is selected from the group consisting of glucose dehydrogenase and glucose oxidase.

20. The biosensor of claim 18, wherein each of the electrodes comprising carbon is formed by screen printing.

21. The biosensor of claim 18, wherein the sensor insertion signal terminal and the counter and working electrodes are formed on the lower base.

22. The biosensor of claim 21, wherein said lower plate is rectangular.

23. The biosensor of claim 22, wherein the sensor insertion signal terminal is rectangular.

24. The biosensor of claim 18, wherein the sensor insertion signal terminal is formed in a rectangular shape.

25. The biosensor of claim 18, wherein the mediator comprises potassium ferricyanide.

26. The biosensor of claim 18, wherein said lower plate is rectangular.

27. A disposable glucose biosensor which is insertable and removable from a device body, said disposable glucose sensor comprising

an upper plate,

a lower plate and a space formed between the two plates for housing a sample therein,

a layer for fixing the two plates together,

a sample opening at a first end edge of the biosensor,

a working electrode and a counter electrode formed on the lower plate, each electrode having an output terminal extension adjacent a second end edge of the base opposite the first edge, and the working electrode having a mediator and one of glucose oxidase and glucose dehydrogenase thereon,

the lower plate comprising an insulating base, and

a sensor insertion signal terminal for interconnecting, upon insertion of the biosensor into the device body, two input terminals of the device body to allow power to flow between the two input terminals through the sensor insertion signal terminal and to the working electrode and said sensor insertion signal terminal being located adjacent said second end edge, and being electrically insulated from the working and counter electrodes while being separated from the space for housing the sample.

28. A disposable glucose biosensor comprising:

an upper plate,

a lower plate comprising a rectangular insulating base having end edges and side edges,

a sample housing space formed between the two plates,

a layer for fixing the two plates together,

a sample opening at a first end edge of the biosensor,

a working electrode formed on the base and positioned to be exposed to the sample housing space,

a counter electrode formed on the base and positioned to be exposed to the sample housing space,

each of the two plates lacking an air vent or hole for connecting to the space,

the working electrode and counter electrode having oxidoreductase and a mediator thereon,

a working electrode output terminal leading from the working electrode along a length of the base, parallel to the side edges, so that the working electrode and the working electrode output terminal form an L-shaped conductive area on the base,

a counter electrode output terminal leading from the counter electrode along a length of the base, parallel to the side edges, so that the counter electrode and the counter electrode output terminal form an L-shaped conductive area on the base, and

an insertion judging electrode formed adjacent a second end edge of the base and electrically insulated from but adjacent each of the counter and working electrode output terminals while being separated from the sample housing space.

29. The biosensor of claim 28, wherein the insertion judging electrode is rectangular in shape.

30. A disposable glucose biosensor which is insertable and removable from a device body, said disposable glucose sensor comprising

an upper plate,

a lower plate,

a space formed between the two plates for housing a sample therein,

a layer for fixing the two plates together,

an opening for admitting the sample at a first end of the biosensor,

a working electrode,

a counter electrode fixed relative to the working electrode,

the working electrode having oxidoreductase thereon,

the lower plate including an insulating base having the working and counter electrodes thereon, and

a sensor insertion signal terminal also formed thereon at an opposite end to the first end for interconnecting, upon insertion of the biosensor into the device body, two input terminals of the device body to allow power to flow between the two input terminals through the sensor insertion signal terminal and to the working electrode and said sensor insertion signal terminal being located adjacent to output terminal extensions of the working and counter electrodes and being electrically insulated from the working and counter electrodes while being separated from the space for housing the sample.

31. In combination, a disposable glucose biosensor which is insertable and removable from a device body,

said disposable glucose sensor including

an upper plate,

a lower plate,

a space formed between the two plates for housing a sample therein,

a layer for fixing the two plates together,

an opening for admitting the sample at a first end of the biosensor,

a working electrode,

a counter electrode fixed relative to the working electrode,

the working electrode having oxidoreductase thereon,

the lower plate including an insulating base having the working and counter electrodes thereon, and

a sensor insertion signal terminal also formed thereon at an opposite end to the first end for interconnecting, upon insertion of the biosensor into the device body, two input terminals of the device body to allow power to flow between the two input terminals through the sensor insertion signal terminal and to the working electrode and said sensor insertion signal terminal being electrically insulated from output terminal extensions of the working and counter electrodes while being separated from the space for housing the sample.