Biosensor

• US 7,918,988 B2
• Filed: 01/31/2008
• Issued: 04/05/2011
• Est. Priority Date: 09/12/1997
• Status: Active Grant

• Current Assignee: Abbott Diabetes Care Incorporated (Abbott Laboratories Incorporated)
• Original Assignee: Abbott Diabetes Care Incorporated (Abbott Laboratories Incorporated)
• Inventors: Mure, Hiroki, Shirakawa, Hiroshi, Gotoh, Masao
• Primary Examiner(s): NOGUEROLA, ALEXANDER STEPHAN
• Application Number:
  US12/068,013
• Publication Number:
  US 20080257725A1
• Time in Patent Office: 1,160 Days
• Field of Search: 20440301-40315, 205/777.5, 205/778, 205/792
• 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. A biosensor comprising:

a first layer and a second layer, the first and second layers being fixed together by a third layer, a working electrode provided on the first layer;

the first, second, and third layers forming a sample receiving space, the sample receiving space comprising a sample receiving opening;

a protrusion extending from the sample receiving opening for aiding in delivery of a biological fluid sample to the sample receiving space, wherein the protrusion is formed only by each of the first and second layers;

and

an enzyme reaction layer in the sample receiving space,

wherein the biosensor is capable of analysis of a sample having a volume of no more than about 1.0 μ

L.

2. The biosensor of claim 1, wherein the enzyme reaction layer has a thickness of about 1-200 μ

m.

3. The biosensor of claim 1, wherein the two layers do not include a hole for venting air from the sample receiving space.

4. The biosensor of claim 1, wherein the third layer is an adhesive layer.

5. The biosensor of claim 1, wherein the third layer is an insulating layer.

6. The biosensor of claim 1, wherein the biosensor comprises a counter electrode, wherein the counter electrode is disposed on the second layer in the sample receiving space.

7. The biosensor of claim 1, wherein a reference electrode is disposed on the first layer and the working and reference electrodes are positioned in the sample receiving space.

8. The biosensor of claim 1, wherein the biosensor comprises a counter electrode disposed on the second layer in the sample receiving space and wherein the working and counter electrodes are disposed in a facing orientation to each other.

9. The biosensor of claim 1, wherein the biosensor comprises an insertion judging electrode, wherein the insertion judging electrode is configured to be contacted by two input terminals of a biosensor device and start the biosensor device when contacted by the two input terminals.

10. The biosensor of claim 1, wherein the biosensor comprises an insertion judging electrode disposed on one of the layers, wherein the insertion judging electrode does not completely extend across a width of the layer.

11. The biosensor of claim 1, wherein the biosensor comprises an insertion judging electrode disposed on one of the layers, wherein the insertion judging electrode is substantially rectangular in shape.

12. The biosensor of claim 1, wherein the biosensor is substantially rectangular in shape.

13. The biosensor of claim 1, wherein the volume of the sample is 0.5 μ

L.

14. The biosensor of claim 1, wherein the biosensor is for analysis of glucose.

15. The biosensor of claim 1, wherein the enzyme reaction layer comprises a mediator and wherein the enzyme reaction layer is disposed on a working electrode.

16. The biosensor of claim 1, wherein the enzyme reaction layer comprises an oxidoreductase and wherein the oxidoreductase is glucose dehydrogenase.

17. The biosensor of claim 1, wherein the enzyme reaction layer comprises an oxidoreductase and wherein the oxidoreductase is glucose oxidase.

18. The biosensor of claim 1, wherein the first layer has a first side edge and a second side edge opposite the first side edge, wherein the first and second side edges are of different lengths.

19. The biosensor of claim 1, wherein the second layer has a third side edge and a fourth side edge opposite the third side edge, wherein the third and fourth side edges are of different lengths and wherein the first side edge and third side edge are of the same length and the second side edge and the fourth side edge are of the same length.

20. The biosensor of claim 1, comprising a counter electrode on the second layer, wherein a lead part of a counter electrode is formed on the first layer, the counter electrode connected to its lead part through the third layer.

21. A biosensor comprising:

a first layer and a second layer, the first and second layers being fixed together by a third layer;

the first, second, and third layers forming a sample receiving space, the sample receiving space comprising a sample receiving opening;

a protrusion extending from the sample receiving opening for aiding in delivery of a biological fluid sample to the sample receiving space, wherein the protrusion is formed by each of the first and second layers and wherein the protrusion is narrower than the sample receiving opening; and

an enzyme reaction layer in the sample receiving space, wherein the biosensor is capable of analysis of a sample having a volume of no more than about 1.0 μ

L.

22. The biosensor of claim 21, wherein the enzyme reaction layer has a thickness of about 1-200 μ

m.

23. The biosensor of claim 21, wherein the two layers do not include a hole for venting air from the sample receiving space.

24. The biosensor of claim 21, wherein the third layer is an adhesive layer.

25. The biosensor of claim 21, wherein the third layer is an insulating layer.

26. The biosensor of claim 21, wherein the bio sensor comprises a counter electrode, wherein the counter electrode is disposed on the second layer in the sample receiving space.

27. The biosensor of claim 21, wherein a reference electrode is disposed on the first layer and the working and reference electrodes are positioned in the sample receiving space.

28. The biosensor of claim 21, wherein the biosensor comprises a counter electrode disposed on the second layer in the sample receiving space and wherein the working and counter electrodes are disposed in a facing orientation to each other.

29. The biosensor of claim 21, wherein the biosensor comprises an insertion judging electrode, wherein the insertion judging electrode is configured to be contacted by two input terminals of a biosensor device and start the biosensor device when contacted by the two input terminals.

30. The biosensor of claim 21, wherein the biosensor comprises an insertion judging electrode disposed on one of the layers, wherein the insertion judging electrode does not completely extend across a width of the layer.

31. The biosensor of claim 21, wherein the biosensor comprises an insertion judging electrode disposed on one of the layers, wherein the insertion judging electrode is rectangular in shape.

32. The biosensor of claim 21, wherein the biosensor is substantially rectangular in shape.

33. The biosensor of claim 21, wherein the volume of the sample is 0.5 μ

L.

34. The biosensor of claim 21, wherein the biosensor is for analysis of glucose.

35. The biosensor of claim 21, wherein the enzyme reaction layer further comprises a mediator and wherein the enzyme reaction layer is disposed on a working electrode.

36. The biosensor of claim 21, wherein the enzyme reaction layer comprises an oxidoreductase, and wherein the oxidoreductase is glucose dehydrogenase.

37. The biosensor of claim 21, wherein the enzyme reaction layer comprises an oxidoreductase, and wherein the oxidoreductase is glucose oxidase.

38. The biosensor of claim 21, wherein the first layer has a first side edge and a second side edge opposite the first side edge, wherein the first and second side edges are of different lengths.

39. The biosensor of claim 38, wherein the second layer has a third side edge and a fourth side edge opposite the third side edge, wherein the third and fourth side edges are of different lengths and wherein the first side edge and third side edge are of the same length and the second side edge and the fourth side edge are of the same length.

40. A method of determining a concentration of an analyte 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 layer and a second layer, the first and second layers being fixed together by a third layer, a working electrode provided on the first layer;

the first, second, and third layers providing a sample receiving space, the sample receiving space comprising a sample receiving opening,

a protrusion extending from the sample receiving opening for aiding in delivery of the body fluid to the sample receiving space, wherein the protrusion is formed only by each of the first and second layers; and

an enzyme reaction layer in the sample receiving space, wherein the biosensor is capable of analysis of a sample having a volume of no more than about 1.0 μ

L; and

determining from the generated electrical signal a concentration of an analyte in body fluid.

41. The method of claim 40, wherein the contacting comprises contacting the body fluid with the protrusion of the biosensor.

42. The method of claim 40, wherein the body fluid ranges from about 0.5 to about 10 microliters.

43. The method of claim 40, wherein the enzyme reaction layer comprises an oxidoreductase, and wherein the oxidoreductase is glucose dehydrogenase.

44. The method of claim 40, wherein the enzyme reaction layer comprises an oxidoreductase, and wherein the oxidoreductase is glucose oxidase.

45. The method of claim 40, wherein the biosensor is connectable to a device body having a control part including a display part and the biosensor further comprises an insertion judging electrode for interconnecting two input terminals of the device body to start the control part of the device body upon connecting the biosensor to the device body.