Biosensor and method for manufacturing the same

• US 7,063,775 B2
• Filed: 05/15/2001
• Issued: 06/20/2006
• Est. Priority Date: 05/16/2000
• Status: Active Grant

• Current Assignee: ARKRAY, Inc
• Original Assignee: ARKRAY, Inc
• Inventors: Yamaoka, Hideaki
• Primary Examiner(s): NOGUEROLA, ALEXANDER STEPHAN
• Application Number:
  US10/276,473
• Publication Number:
  US 20030111344A1
• Time in Patent Office: 1,862 Days
• Field of Search: 204/403.01, 204/403.02, 204/403.06, 204/403.14, 204/409, 204/415
• US Class Current: 204/403.06
• CPC Class Codes: C12Q 1/002 Electrode membranes
• CPC Class Codes: G01N 2333/904 acting on CHOH groups as donors, e.g. glucose oxidase, lactate dehydrogenase (1.1)
• 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: Y10T 29/49002 Electrical device making

Abstract

A biosensor (I) which comprises a capillary (3) having a passage (30) fined with an inlet (30a) for taking a sample solution therein, a membrane (8) for accelerating the transference of a sample solution in the passage (30), and a reaction portion (7) containing a reagent which reacts with a component to be detected in a sample solution.

Claims

1. A biosensor, comprising:

a capillary having a channel with an inlet port for taking in a sample liquid;

a membrane for promoting movement of said sample liquid through said channel, the membrane being asymmetric and having undergone no hydrophilic treatment; and

a reaction part containing a reagent that reacts with a component to be tested in a sample liquid whose movement has been promoted by said membrane;

wherein said membrane comprises, thicknesswise, a first layer having smaller pores, and a second layer having larger pores, said first layer being held in contact with said reaction part;

and said membrane is laminated on said reaction part.

2. The biosensor according to claim 1, wherein said membrane is provided in the vicinity of said inlet port.

3. The biosensor according to claim 1, wherein said membrane has a plurality of pores each of which is no less than 0.25 μ

m but no more than 45 μ

m in diameter.

4. The biosensor according to claim 1, wherein said reaction part and said membrane are formed to extend to said inlet port.

5. The biosensor according to claim 1, wherein the pores of said first layer have a pore diameter of no less than 0.25 μ

m but no more than 0.45 μ

m, and the pores of said second layer have a pore diameter of no less than 25 μ

m but no more tan 45 μ

m.

6. The biosensor according to claim 1, wherein said capillary has an opening serving as an air escape hole.

7. The biosensor according to claim 1, wherein said capillary has a transparent part or semitransparent part for internally observing said capillary.

8. The biosensor according to claim 7, wherein said membrane is white.

9. The biosensor according to claim 1, further comprising an elongate working electrode and an elongate counter electrode provided on an insulating base, wherein said capillary is formed to intersect said working electrode and said counter electrode on said insulating base.

10. The biosensor according to claim 9, wherein said counter electrode is generally parallel to said working electrode.

11. The biosensor according to claim 9, wherein said capillary comprises a pair of upright walls on said base, and a cover bridging the pair of walls.

12. The biosensor according to claim 1, wherein said membrane draws a sample liquid in a direction of substantially constant pore size in a longitudinal direction of said channel.

13. A method for manufacturing a biosensor which comprises a capillary having a channel with an inlet port for taking in a sample liquid, a membrane for promoting movement of said sample liquid through said channel, and a reaction part containing a reagent that reacts with a component to be tested in said sample liquid whose movement has been promoted by said membrane;

the method comprising the steps of;

forming a working electrode and a counter electrode in an elongate configuration on an insulating base;

forming an elongate reaction part intersecting said working electrode and said counter electrode;

laminating an elongate membrane on said reaction part, said membrane being asymmetric and having undergone no hydrophilic treatment;

providing a pair of walls along longitudinal edges on both sides of said reaction part and said membrane; and

forming a capillary by forming a cover bridging said pair of walls;

wherein said membrane comprises, thicknesswise, a first layer having smaller pores, and a second layer having larger pores, said first layer being held in contact with said reaction part.

14. The biosensor manufacturing method according to claim 13, wherein said pair of walls is formed by applying a hot melt adhesive.

15. The biosensor manufacturing method according to claim 13, wherein said pair of walls is formed by sticking double-sided tape onto said insulating base.

16. A biosensor for testing a sample liquid, comprising:

a capillary having a channel with an inlet port for taking in a sample liquid;

a membrane for promoting movement of said sample liquid through said channel, said membrane being asymmetric and arranged not to cause hemolysis that lowers measurement accuracy in testing the sample liquid; and

a reaction part containing a reagent that reacts with a component to be tested in said sample liquid whose movement has been promoted by said membrane;

wherein said membrane comprises, thicknesswise, a first layer having smaller pores, and a second layer having larger pores, said first layer being held in contact with said reaction part;

and said membrane is laminated on said reaction part.