Biosensor

• US 8,557,103 B2
• Filed: 07/12/2011
• Issued: 10/15/2013
• Est. Priority Date: 09/12/1997
• Status: Expired due to Term

• Current Assignee: Abbott Diabetes Care Incorporated (Abbott Laboratories Incorporated)
• Original Assignee: Abbott Diabetes Care Incorporated (Abbott Laboratories Incorporated)
• Inventors: Gotoh, Masao, Mure, Hiroki, Shirakawa, Hiroshi
• Primary Examiner(s): Noguerola, Alex
• Application Number:
  US13/181,208
• Publication Number:
  US 20110308970A1
• Time in Patent Office: 826 Days
• Field of Search: 20440301-40315, 205/777.5, 205/778, 205/792
• US Class Current: 205/792
• 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 biosensor for measuring a concentration of glucose in a sample, the biosensor comprising:

a first substrate and a second substrate disposed over the first substrate, wherein the first and second substrates define a biosensor comprising a proximal end having a width and a distal end having a width, the distal end being configured for insertion into a biosensor reader, wherein the width of the distal end is greater than the width of the proximal end;

a spacer layer disposed between the first and second substrates and defining an aperture along a first side edge of the biosensor configured to receive a sample fluid;

a working electrode disposed on the first substrate;

a mediator and a glucose dehydrogenase disposed on the working electrode; and

a counter/reference electrode disposed on the second substrate,

wherein the second substrate comprises a cut-out portion at the distal end to expose a portion of the working electrode disposed on the first substrate.

2. The biosensor of claim 1, wherein the first substrate, second substrate and spacer layer define a space for housing a sample, the space for housing a sample being in communication with the aperture and having a volume that is no more than 1.0 μ

L.

3. The biosensor of claim 2, wherein the space for housing a sample has a volume that is no more than 0.5 μ

L.

4. The biosensor of claim 1, wherein the spacer layer defines an aperture along a second side edge of the biosensor configured to receive a sample fluid.

5. The biosensor of claim 4, wherein the aperture along the first side edge is in communication with the aperture along the second side edge.

6. The biosensor of claim 1, wherein the working electrode is constructed of a palladium material.

7. The biosensor of claim 1, wherein the counter/reference electrode is constructed of a gold material.

8. The biosensor of claim 1, wherein the working electrode is constructed of a palladium material and the counter/reference electrode is constructed of a gold material.

9. The biosensor of claim 1, wherein the mediator is potassium ferricyanide or parabenzoquinone.

10. A method of determining a concentration of glucose in a subject, the method comprising:

contacting body fluid of the subject with a biosensor to generate an electrical signal, the biosensor comprising;

a first substrate and a second substrate disposed over the first substrate, wherein the first and second substrates define a biosensor comprising a proximal end having a width and a distal end having a width, the distal end being configured for insertion into a biosensor reader, wherein the width of the distal end is greater than the width of the proximal end;

a spacer layer disposed between the first and second substrates and defining an aperture along a first side edge of the biosensor configured to receive a sample fluid;

a working electrode disposed on the first substrate;

a mediator and a glucose dehydrogenase disposed on the working electrode; and

a counter/reference electrode disposed on the second substrate,

wherein the second substrate comprises a cut-out portion at the distal end to expose a portion of the working electrode disposed on the first substrate,

determining the concentration of glucose in the body fluid using the generated electrical signal.

11. The method of claim 10, wherein determining the concentration of glucose comprises determining the concentration of glucose by amperometry using the generated electrical signal.

12. The method of claim 10, wherein the first substrate, second substrate and spacer layer define a space for housing a sample, the space for housing a sample being in communication with the aperture and having a volume that is no more than 1.0 μ

L.

13. The method of claim 12, wherein the space for housing a sample has a volume that is no more than 0.5 μ

L.

14. The method of claim 10, wherein the spacer layer defines an aperture along a second side edge of the biosensor configured to receive a sample fluid.

15. The method of claim 14, wherein the aperture along the first side edge is in communication with the aperture along the second side edge.

16. The method of claim 10, wherein the working electrode is constructed of a palladium material.

17. The method of claim 10, wherein the counter/reference electrode is constructed of a gold material.

18. The method of claim 10, wherein the mediator is potassium ferricyanide or parabenzoquinone.

19. A biosensor device comprising:

a device body having a connector part and a control part, the connector part having input terminals;

a biosensor comprising;

a first substrate and a second substrate disposed over the first substrate, wherein the first and second substrates define a biosensor comprising a proximal end having a width and a distal end having a width, the distal end being configured for insertion into a biosensor reader, wherein the width of the distal end is greater than the width of the proximal end;

a spacer layer disposed between the first and second substrates and defining an aperture along a first side edge of the biosensor configured to receive a sample fluid;

a working electrode disposed on the first substrate;

a mediator and a glucose dehydrogenase disposed on the working electrode; and

a counter/reference electrode disposed on the second substrate,

wherein the second substrate comprises a cut-out portion at the distal end to expose a portion of the working electrode disposed on the first substrate,

wherein the input terminals of the connector part are electrically connected to the exposed portion of the working electrode when the biosensor is inserted into the connector part of the device body.

20. The biosensor device of claim 19, wherein the first substrate, second substrate and spacer layer define a space for housing a sample, the space for housing a sample being in communication with the aperture and having a volume that is no more than 1.0 μ

L.

21. The biosensor device of claim 20, wherein the space for housing a sample has a volume that is no more than 0.5 μ

L.

22. The biosensor device of claim 19, wherein the spacer layer defines an aperture along a second side edge of the biosensor configured to receive a sample fluid.

23. The biosensor device of claim 22, wherein the aperture along the first side edge is in communication with the aperture along the second side edge.

24. The biosensor device of claim 19, wherein the working electrode is constructed of a palladium material.

25. The biosensor device of claim 19, wherein the counter/reference electrode is constructed of a gold material.

26. The biosensor device of claim 19, wherein the mediator is potassium ferricyanide or parabenzoquinone.