Biosensor

• US 20120055812A1
• Filed: 09/06/2011
• Published: 03/08/2012
• Est. Priority Date: 09/12/1997
• Status: Active Grant

• Current Assignee: Abbott Diabetes Care Incorporated (Abbott Laboratories)
• Original Assignee: Abbott Diabetes Care Incorporated (Abbott Laboratories)
• Inventors: Gotoh, Masao, Mure, Hiroki, Shirakawa, Hiroshi
• Granted Patent: US 8,414,761 B2
• Time in Patent Office: Days
• US Class Current: 205/777.5
• 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

1-18. -18. (canceled)

19. A biosensor for determining 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 sensor comprising a proximal end and a distal end, the distal end being configured for insertion into a sensor reader, wherein the proximal end comprises a narrow portion as compared to the distal end, and wherein the first substrate comprises a length extending from the proximal end to the distal end and the second substrate comprises a length extending from the proximal end to the distal end, wherein the length of the second substrate is greater than the length of the first substrate;

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

a working electrode disposed on the narrow portion of the proximal end of the first substrate and extending to the distal end of the first substrate;

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

a counter/reference electrode disposed on the narrow portion of the proximal end of the second substrate and extending to the distal end of the second substrate.

20. The biosensor of claim 19, wherein the spacer layer comprises a length extending from the proximal end to the distal end, wherein the length of the spacer layer is shorter than the length of the first substrate and the length of the second substrate.

21. The biosensor 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.

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

L.

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

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

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

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

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

28. 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 sensor comprising a proximal end and a distal end, the distal end being configured for insertion into a sensor reader, wherein the proximal end comprises a narrow portion as compared to the distal end, and wherein the first substrate comprises a length extending from the proximal end to the distal end and the second substrate comprises a length extending from the proximal end to the distal end, wherein the length of the second substrate is greater than the length of the first substrate;

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

a working electrode disposed on the narrow portion of the proximal end of the first substrate and extending to the distal end of the first substrate;

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

a counter/reference electrode disposed on the narrow portion of the proximal end of the second substrate and extending to the distal end of the second substrate; and

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

29. The method of claim 28, wherein determining the concentration of glucose comprises determining the concentration of glucose by amperometry using the generated electrical signal.

30. The method of claim 28, wherein the spacer layer comprises a length extending from the proximal end to the distal end, wherein the length of the spacer layer is shorter than the length of the first substrate and the length of the second substrate.

31. The method of claim 28, 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.

32. The method of claim 31, wherein the space for housing a sample has a volume that is no more than 0.5 μ

L.

33. The method of claim 28, wherein the spacer layer defines an aperture along a second side edge of the biosensor configured to receive a sample fluid.

34. The method of claim 33, wherein the aperture along the first side edge is in communication with the aperture along the second side edge.

35. The method of claim 28, wherein the working electrode is constructed of a palladium material.

36. The method of claim 28, wherein the counter/reference electrode is constructed of a gold material.

37. The method of claim 28, wherein the mediator is potassium ferricyanide or parabenzoquinone.

38. 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 sensor comprising a proximal end and a distal end, the distal end being configured for insertion into a sensor reader, wherein the proximal end comprises a narrow portion as compared to the distal end, and wherein the first substrate comprises a length extending from the proximal end to the distal end and the second substrate comprises a length extending from the proximal end to the distal end, wherein the length of the second substrate is greater than the length of the first substrate;

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

a working electrode disposed on the narrow portion of the proximal end of the first substrate and extending to the distal end of the first substrate;

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

a counter/reference electrode disposed on the narrow portion of the proximal end of the second substrate and extending to the distal end of the second substrate,

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

39. The biosensor device of claim 38, wherein the spacer layer comprises a length extending from the proximal end to the distal end, wherein the length of the spacer layer is shorter than the length of the first substrate and the length of the second substrate.

40. The biosensor device of claim 38, 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.

41. The biosensor device of claim 40, wherein the space for housing a sample has a volume that is no more than 0.5 μ

L.

42. The biosensor device of claim 38, wherein the spacer layer defines an aperture along a second side edge of the biosensor configured to receive a sample fluid.

43. The biosensor device of claim 42, wherein the aperture along the first side edge is in communication with the aperture along the second side edge.

44. The biosensor device of claim 38, wherein the working electrode is constructed of a palladium material.

45. The biosensor device of claim 38, wherein the counter/reference electrode is constructed of a gold material.

46. The biosensor device of claim 38, wherein the mediator is potassium ferricyanide or parabenzoquinone.