Biosensors

• US 20050247573A1
• Filed: 03/22/2005
• Published: 11/10/2005
• Est. Priority Date: 03/23/2004
• Status: Abandoned Application

• Current Assignee: National Institute of Advanced Industrial Science and Technology (Government of Japan)
• Original Assignee: National Institute of Advanced Industrial Science and Technology (Government of Japan)
• Inventors: Shinohara, Shouji, Nakamura, Hideaki, Gotoh, Masao, Karube, Isao
• Application Number:
  US11/087,015
• Publication Number:
  US 20050247573A1
• Time in Patent Office: Days
• US Class Current: 205/777.500
• CPC Class Codes: G01N 27/3272 Test elements therefor, i.e. disposable laminated substrates with electrodes, reagent and channels optical biosensors G01N33/52

Abstract

The biosensors of the present invention comprise an electrically insulating substrate, an electrically insulating cover connected to the substrate via a spacer layer, a reaction-detecting section formed on the substrate at a region sandwiched between the substrate and cover, and comprising at least one set of electrodes, and an external terminal to be connected to the reaction-detecting section, and a sealed sample-feeding path defined between the substrate and cover by the spacer layer, where the sample-feeding path has a portion intersecting the electrodes, as well as a cutting plane line provided at an outermost surface of the substrate or cover, which is a boundary between a sensor portion comprising electrodes and a sealed cap portion which does not comprise electrodes, and the cutting plane line is present at a position where, when the sealed cap portion is cut along the cutting plane line, the cut surface does not cross the electrodes and does cross the sample-feeding path, so that a sample-inlet port and an air-discharge port leading from the sample-feeding path are exposed through the cut surface. In addition, the biosensors for simultaneously measuring multiple items of the present invention comprise: a substrate; a cover connected to the substrate via a spacer layer; and a number of biosensor units comprising substrates each containing at least one biosensor unit which comprises a reaction-detecting section including one electrode system and one reagent layer on the substrate, and a sample-feeding path including the reagent layer, wherein each of the biosensor units comprise one reagent layer on one sample-feeding path, a cutting plane line for dividing each of the biosensor unit-comprising substrates is provided at a top surface of the substrate or cover, the cutting plane line and sample-feeding path are placed such that, when the substrate or cover is cut along the cutting plane line, a sample-inlet port for supplying a sample solution is open to a cut surface of each biosensor unit-comprising substrate as a cut port of the sample-feeding path.

Claims

1. A biosensor comprising:

an electrically insulating substrate;

an electrically insulating cover connected to the substrate via a spacer layer;

a reaction-detecting section comprising at least one set of electrodes, and an external terminal to be connected to the reaction-detecting section, both of which are formed on the substrate at a region between the substrate and cover; and

a sealed sample-feeding path defined by the spacer layer between the substrate and cover, wherein the sample-feeding path comprises a portion that intersects the electrodes,

a cutting plane line is provided at an outermost surface of the substrate or cover, and is bordered by a sensor portion comprising the electrodes and a sealed cap portion which does not comprise the electrodes,

the cutting plane line exists at a position where, when the sealed cap portion is cut along the cutting plane line, the cut surface does not cross the electrodes, and the cut surface crosses the sample-feeding path so that a sample-inlet port and air-discharge port from the sample-feeding path are exposed through the cut surface.

2. The biosensor of claim 1, wherein the cutting plane line is formed by notches or cuts, and the notches or cuts are laid out to face the same positions on the substrate and cover.

3. The biosensor of claim 1, wherein the substrate and cover each comprise a multilayer structure of at least two or more layers, and the cutting plane line is formed to leave at least an innermost layer of the multilayer structure.

4. The biosensor of claim 1, wherein a reagent layer is provided at a region where the sample-feeding path crosses the electrode.

5. The biosensor of claim 1, wherein a part of the region sandwiched between the substrate and cover comprises a desiccant and/or deoxidant.

6. The biosensor of claim 5, wherein the desiccant and/or deoxidant is comprised in a sealed cap portion.

7. The biosensor of claim 1, wherein a part of the region sandwiched between the substrate and cover comprises a humidity indicator and/or oxygen-detecting agent.

8. The biosensor of claim 7, wherein a part or all of the substrate and/or cover is of a material transparent to visible rays, and thus the humidity indicator and/or oxygen-detecting agent is visible.

9. The biosensor of claim 1, wherein the substrate and/or cover are made of a material that does not transmit ultraviolet.

10. The biosensor of claim 1, wherein a top surface of the substrate and/or cover is coated with an ultraviolet absorber or a material that does not transmit ultraviolet.

11. The biosensor of claim 1, wherein the substrate or cover comprise a compound with a photocatalytic effect, or where a top surface of the substrate and/or cover is coated with a layer comprising a compound with a photocatalytic effect.

12. The biosensor of claim 1, wherein the spacer layer comprises a fluorescent or luminescent agent close to an exposed sample-inlet port and air-discharge port.

13. The biosensor of claim 1, wherein the electrodes form an array.

14. The biosensor of claim 13, wherein at least one sample-inlet port is exposed when the sealed cap portion is cut along the cutting plane line, and the reaction-detecting section comprising at least one set of electrodes is located ahead of the sample-feeding path connected to the sample-inlet port.

15. The biosensor of claim 14, wherein the at least one sample-inlet port is connected to at least two sample-feeding paths branched from the sample-inlet port, and the reaction-detecting section comprising at least one set of electrodes is located ahead of the sample-feeding path.

16. The biosensor of claim 8, wherein the substrate and/or cover comprising a material transparent to visible rays is coated with a protective film.

17. The biosensor of claim 1, wherein the external terminal is coated with a protective film.

18. The biosensor of claim 1, wherein the external terminal is covered with the cover, and the cover has a fold-line foldable in such a way as to expose the external terminal.

19. A biosensor package retaining a plurality of the biosensor of claim 1.

20. A biosensor aggregation sheet comprising a plurality of the biosensors of claim 1, regularly laid out at predetermined intervals, wherein a cut-away perforation is provided at a substrate of an adjoining biosensor.

21. A method for using the biosensor of claim 1, wherein the method comprises the step of cutting off a sealed cap to form a sample-inlet port and an air-discharge port.

22. A biosensor device comprising:

the biosensor of claim 1;

a measuring section for measuring an electrical value at a reaction-detecting section of the biosensor;

a display section for displaying a value measured in the measuring section; and

a memory section for saving the measured value.

23. The biosensor device of claim 22, wherein the measuring method in the measuring section is any one of potential step chronoamperometry, coulometry, and cyclic voltammetry.

24. The biosensor device of claim 22, wherein the biosensor comprises a wireless means for transmitting measurement data to the measuring section, and the wireless means is a non-contact IC card or Bluetooth.

25. A biosensor for simultaneously measuring multiple items, comprising:

a substrate;

a cover connected to the substrate via a spacer layer; and

a number of biosensor unit-comprising substrates, containing at least one biosensor unit which comprises a reaction-detecting section that includes one electrode and one reagent layer on the substrate, and a sample-feeding path that includes the reagent layer,

wherein each of the biosensor units comprises one reagent layer on one sample-feeding path,

a cutting plane line for dividing each of the biosensor unit-comprising substrates is provided at a top surface of the substrate or cover,

the cutting plane line and sample-feeding path are placed such that, when the substrate or cover is cut along the cutting plane line, a sample-inlet port that supplies a sample solution to the sample-feeding path opens at a cut surface of each biosensor unit-comprising substrate, as a cut port of the sample-feeding path.

26. The biosensor of claim 25, wherein the sample-feeding path is provided such that the sample-inlet port opens at the cut surface, and an air-discharge port is provided at the surface of the substrate or cover, or at a side surface of the biosensor unit-comprising substrate which differs from the cut surface.

27. The biosensor of claim 25, wherein the sample-feeding path is sealed;

a cutting plane line (the first cutting plane line), which divides each of the biosensor unit-comprising substrates, and a second cutting plane line, which is different from the first cutting plane line and is used to expose the air-discharge port by cutting parts of the substrate and cover, are provided on a top surface of the substrate or cover; and

the first and second cutting plane lines and the sample-feeding path are arranged such that the sample-inlet port opens as a cut opening on the first cut surface when the substrate or cover is cut along the first cut surface, and such that the air-discharge port opens as a cut opening on the second cut surface when the substrate or cover is cut along the second cut surface.

28. The biosensor of claim 27, equipped with an auxiliary device on a surface of the substrate or cover, such that the substrate or cover are bent along the second cutting plane line in response to bending of the substrate or cover along the first cutting plane line.

29. The biosensor of claim 25, wherein the sample-feeding path is provided such that both the sample-inlet port and air-discharge port open to a cut surface of each of the biosensor unit-comprising substrates, and the sample-feeding path is set up in a sealed state, prior to cutting.

30. The biosensor of claim 25, wherein the sample-feeding path is laid out such that a sample-inlet port forms for every biosensor unit.

31. The biosensor of claim 25, wherein at least one of the substrate or cover comprises a multilayer structure comprising at least two layers, and the cutting plane line is formed at any one of the layers of the multilayer structure, excluding the innermost layer.

32. The biosensor of claim 25, wherein the electrodes form an array.

33. A method for using the biosensor of claim 25, wherein said method comprises the steps of:

(1) bending the substrate or cover along a cutting plane line which divides the biosensor unit-comprising substrates, and cutting the substrate or cover to open the cut opening (sample-inlet port) of the sample-feeding path on the cut surface of each biosensor unit-comprising substrate;

(2) fixing the shape of the bent biosensor unit-comprising substrate to keep the sample-inlet port open;

(3) contacting the open sample-inlet port with a solution comprising a measuring target; and

(4) supplying the solution comprising the measuring target to the sample-feeding path.

34. The method of claim 33, wherein the bending in step (1) is carried out such that the cut surface is exposed and one substrate is cut while the other substrate is left connected, and wherein step (3) is carried out with the biosensor bent.

35. The method of claim 33, wherein step (3) comprises contacting the sample-inlet ports of two or more biosensor unit-comprising substrates with the solution at one time.

36. The method of claim 33, wherein the biosensor unit-comprising substrate comprises two or more biosensor units, and step (2) comprises contacting one sample-inlet port of the biosensor unit-comprising substrates with a solution at the same time.

37. A method for measuring a measuring target using the biosensor of claim 25, wherein the method comprises the steps of:

(1) bending the substrate or cover along a cutting plane line which divides the biosensor unit-comprising substrates, and cutting the substrate or cover to open a cut opening (sample-inlet port) of the sample-feeding path on the cut surface of each biosensor unit-comprising substrate;

(2) fixing the shape of the bent biosensor unit-comprising substrate to keep the sample-inlet port open;

(3) contacting the open sample-inlet port with a solution comprising a measuring target;

(4) supplying the solution comprising the measuring target to the sample-feeding path; and

(5) measuring the measuring targets with each of the biosensors.

38. A biosensor device comprising:

a biosensor of claim 25;

a connector section which captures electric signals at biosensor electrodes;

a measuring section which measures an electrical value via the connector section;

a display section which displays the value measured in the measuring section; and

a memory section which saves the measured value.

39. The biosensor device of claim 38, wherein the connector section comprises a structure for:

altering the shape of the biosensor unit-comprising substrate for opening the sample-inlet port;

fixing the biosensor unit-comprising substrate with the shape; and

then capturing electrical signals at the biosensor electrodes.

40. The biosensor device of claim 36, wherein the measuring method in the measuring section is potential step chronoamperometry, coulometry, or cyclic voltammetry.

41. A connector for use in biosensors, for fixing the biosensor of claim 25 to capture electrical signals, wherein the connector comprises:

a sensor shape-fixing section that fixes the bent shape of the biosensor unit-comprising substrate to open the sample-inlet port; and

an electrical connection section or wiring for capturing electrical signals on the biosensor, and electrical signals at the biosensor electrodes.