Electrochemical biosensor with sample introduction channel capable of uniform introduction of small amount of sample

• US 9,512,458 B2
• Filed: 10/24/2008
• Issued: 12/06/2016
• Est. Priority Date: 10/29/2007
• Status: Active Grant

• Current Assignee: i-SENS, Inc.
• Original Assignee: i-SENS, Inc.
• Inventors: Yoo, Jae Hyun, Kim, Ju Yong, Cui, Gang, Kim, Keun Ki, Kim, Moon Hwan, Nam, Hakhyun, Cha, Geun Sig
• Primary Examiner(s): RUFO, LOUIS J
• Application Number:
  US12/740,016
• Publication Number:
  US 20110011739A1
• Time in Patent Office: 2,965 Days
• Field of Search: 204/403.01, 204/403.02, 204/403.04
• US Class Current: 1/1
• CPC Class Codes: B01L 2300/0645 Electrodes
• CPC Class Codes: B01L 2300/0825 Test strips
• CPC Class Codes: B01L 2300/0887 Laminated structure
• CPC Class Codes: B01L 2400/0406 capillary forces
• CPC Class Codes: B01L 3/5027 by integrated microfluidic structures, i.e. dimensions of channels and chambers are such that surface tension forces are important, e.g. lab-on-a-chip B01L3/5023 takes precedence; micromixers B01F33/30; microreactors for synthesis B01J19/0093; microcapillary devices in general B81B1/00
• CPC Class Codes: C12Q 1/006 for glucose
• CPC Class Codes: G01N 27/3272 Test elements therefor, i.e. disposable laminated substrates with electrodes, reagent and channels optical biosensors G01N33/52

Abstract

Disclosed is an electrochemical biosensor having a sample introduction channel in which an insulator is employed to introduce a small amount of a sample uniformly and accurately and to adjust an area of a working electrode, thereby guaranteeing the accurate quantitative analysis of a sample. Provided with a sample collection barrier at a sample entrance, the biosensor allows a sample to be introduced at higher accuracy and to be analyzed with higher reproducibility and reliability.

Claims

1. An electrochemical biosensor, comprising:

a lower plate, upon which is constructed a working electrode coated with a reagent layer containing an electron transfer mediator and a redox enzyme, and a reference electrode;

a middle plate having a precut pattern defining a sample introduction channel composed of a sample entrance for introducing a sample into said electrochemical biosensor, a sample passage and an air vent ;

a lower insulator located between the middle plate and the lower plate;

an upper insulator located above the middle plate wherein the upper insulator roofs over the air vent, the upper insulator preventing migration of the sample into the air vent; and

an upper plate or a cover that forms a sample cell structure,

wherein the sample entrance is tapered and narrows toward the sample passage,

wherein at least a portion of the working electrode is exposed in the sample passage for direct contact with a sample introduced into the sample entrance;

the lower insulator has a precut pattern having the same structure as the precut pattern of the sample passage aligned therewith, the precut pattern of the lower insulator having a bottom wall extending across the sample passage on the same plane as the lower insulator and directly below the sample passage with a hydrophobic sample collection barrier located directly below the sample entrance and between the sample entrance of the middle plate and the lower plate such that the hydrophobic sample collection barrier does not further extend to be below the sample passage; and

the hydrophobic sample collection barrier protrudes from the lower plate toward the sample entrance, the hydrophobic sample collection barrier having a predetermined height of 1 μ

m to 10 μ

m and extends across the sample entrance when the lower plate, lower insulator middle plate and upper plate are assembled.

2. The electrochemical biosensor according to claim 1, wherein the sample introduction channel has a precut pattern in which the sample passage is crossed with the air vent.

3. The electrochemical biosensor according to claim 1, wherein the precut pattern of the lower insulator is screen printed on the lower plate in a manner such that the precut pattern of the lower insulator have the same structure as the precut pattern of the sample passage and the air vent in the middle plate.

4. The electrochemical biosensor according to claim 1, wherein the lower insulator is made of a urethane or a polyacrylate.

5. The electrochemical biosensor according to claim 1, wherein the upper insulator is made of a urethane or a polyacrylate.

6. The electrochemical biosensor according to claim 1, wherein the precut pattern of the lower insulator has the same structure as the precut pattern of the sample passage, the air vent and a void in the middle plate.

7. The electrochemical biosensor according to claim 1, wherein the hydrophobic sample collection barrier has a lip positioned directly below the sample entrance once the sample is brought into contact with the sample entrance such that the lip backs the sample at the sample entrance.

8. The electrochemical biosensor according to claim 1, wherein said height of the hydrophobic sample collection barrier is the same as a thickness of the lower insulator.

9. An electrochemical biosensor, comprising:

a lower plate, upon which is constructed a working electrode coated with a reagent layer containing an electron transfer mediator and a redox enzyme, and a reference electrode;

a middle plate having a precut pattern defining a sample introduction channel composed of a sample entrance, a sample passage and an air vent;

a lower insulator located between the middle plate and the lower plate;

an upper insulator located above the middle plate wherein the upper insulator roofs over the air vent, the upper insulator preventing migration of the sample into the air vent; and

an upper plate or a cover that forms a sample cell structure,

wherein the sample entrance is tapered and narrows toward the sample passage,

wherein at least a portion of the working electrode is exposed in the sample passage for direct contact with a sample introduced into the sample entrance;

the lower insulator has a precut pattern with a hydrophobic sample collection barrier of a predetermined height of 1 to 10 μ

m located directly below the sample entrance of the middle plate and extending across the sample entrance such that the hydrophobic sample collection barrier does not further extend to be below the sample passage, the hydrophobic sample collection barrier having a lip positioned directly below the sample entrance once the sample is applied to the sample passage such that the lip backs the sample at the sample entrance to uniformly distribute the sample in the sample passage;

wherein the lower insulator having the precut pattern is applied onto the lower plate, the precut pattern of the lower insulator having the same structure as the precut pattern of the sample passage in the middle plate and is aligned therewith.