Biosensor provided with code electrode, method for manufacturing the same, and method for obtaining sensor information from the same

• US 8,702,966 B2
• Filed: 06/30/2009
• Issued: 04/22/2014
• Est. Priority Date: 02/19/2009
• Status: Active Grant

• Current Assignee: ALL Medicus Co., Ltd.
• Original Assignee: ALL Medicus Co., Ltd.
• Inventors: Ahn, Yon Chan, Park, Mi Suk, Cha, Min Seok, Jung, Hye Sook
• Primary Examiner(s): Ball, J. Christopher
• Assistant Examiner(s): DIETERLE, JENNIFER M
• Application Number:
  US13/121,539
• Publication Number:
  US 20120142117A1
• Time in Patent Office: 1,757 Days
• Field of Search: 20440301-40315, 600345-348, 205/775, 205/777.5, 205/778, 205/792, 435/287.1, 422/68.1, 422/82.01, 298/47, 427/555
• US Class Current: 205/792
• CPC Class Codes: G01N 33/48771 Coding of information, e.g. calibration data, lot number
• CPC Class Codes: Y10T 29/49156 with selective destruction of conductive paths

Abstract

The present invention provides a biosensor having a code electrode, a method for manufacturing the same, and a method for obtaining sensor information on the same, in which a code electrode for providing sensor information such as correction information, the type of biosensor, etc. is provided in each biosensor such that a measuring device can obtain necessary information on each biosensor from the code electrode, thus solving a variety of conventional problems.

Claims

1. A biosensor, in which a working electrode and a reference electrode are formed on an inner surface of a lower insulating substrate, a reagent reaction layer is fixed on the inner surface of the lower insulating substrate along a sample path to be in contact with the working electrode and the reference electrode, and an upper insulating substrate is assembled with the lower insulating substrate with a spacer interposed therebetween to form the sample path,

wherein a code electrode outputs an electrical signal according to a reaction between a sample and the reaction reagent layer, and provides the electrical signal to a measuring device,

wherein the code electrode comprises a code pattern portion, formed by patterning the code electrode at a position which is in contact with the reagent reaction layer, wherein an area of the code pattern portion is varied according to sensor information, wherein the code electrode is configured to output the electrical signal according to the sensor information, and

wherein the code pattern portion is patterned by removing a predetermined area of the code electrode such that the contact area with the reagent reaction layer, in which reaction current flows, differs according to a code assigned to a corresponding biosensor based on the sensor information.

2. The biosensor of claim 1, wherein the code pattern portion is formed by removing a predetermined area of the code electrode in a longitudinal direction or a width direction of the code electrode.

3. The biosensor of claim 1, wherein the code electrode is formed on the inner surface of the lower insulating substrate.

4. The biosensor of claim 3, wherein, the code pattern portion is formed by ablating the predetermined area of the code electrode together with the reagent reaction layer with irradiating a laser beam onto the inner surface of the lower insulating substrate.

5. The biosensor of claim 3, wherein, the code pattern portion is formed by ablating the predetermined area of the code electrode together with the lower insulating substrate with irradiating a laser beam onto an outer surface of the lower insulating substrate.

6. The biosensor of claim 1, wherein the code electrode is formed on an inner surface of the upper insulating substrate.

7. The biosensor of claim 6, wherein, the code pattern portion is formed by ablating the predetermined area of the code electrode with irradiating a laser beam onto the inner surface of the upper insulating substrate.

8. The biosensor of claim 6, wherein, the code pattern portion is formed by ablating the predetermined area of the code electrode together with the upper insulating substrate with irradiating a laser beam onto an outer surface of the upper insulating substrate.

9. The biosensor of claim 1, wherein the code electrode comprises:

a first code electrode portion formed on the inner surface of the upper insulating substrate to be in contact with the reagent reaction layer;

an intermediate conductive portion fixed on the spacer to be connected to one end of the first code electrode portion; and

a second code electrode portion formed on the inner surface of the lower insulating substrate such that one end thereof is connected to an intermediate conductive portion of the spacer and an other end thereof is connected to a socket terminal of the measuring device.

10. The biosensor of claim 1, wherein the sensor information is correction information of the corresponding biosensor or information on the type of the bio-sensor.

11. The biosensor of claim 1, wherein a notch portion formed by forming a notch on any one of the upper insulating substrate and the lower insulating substrate is provided around a sample inlet port of the sample path so as to prevent the sample inlet port from being clogged by a user'"'"'s body being in contact with the sample inlet port.

12. The biosensor of claim 1, wherein a sample inlet port of the sample path is located at an end of the biosensor, and the sample path and the reagent reaction layer are arranged in a longitudinal direction of the biosensor.

13. The biosensor of claim 1, wherein a code recognition electrode for providing sensor information is additionally formed on an outer surface of the lower insulating substrate, the code recognition electrode having a different shape according to a code assigned to the corresponding biosensor based on the sensor information such that socket terminals of the measuring device can be distinguished according to the assigned code.

14. The biosensor of claim 1, wherein a sensing electrode for determining a sample filled state in the sample path is additionally formed to be in contact with the reagent reaction layer such that the electrodes are arranged in an order of the working electrode, the reference electrode, the code electrode, and the sensing electrode for determining the sample filled state with respect to a flow direction of the sample in the sample path.

15. The biosensor of claim 1, wherein a sensing electrode for determining a sample injection time point and a sensing electrode for determining a sample filled state in the sample path are additionally formed to be in contact with the reagent reaction layer such that the electrodes are arranged in an order of the sensing electrode for determining the sample injection time point, the working electrode, the reference electrode, the code electrode, and the sensing electrode for determining the sample filled state with respect to a flow direction of the sample in the sample path.

16. A method for manufacturing a biosensor having a code electrode, the method comprising:

forming a working electrode and a reference electrode on an inner surface of a lower insulating substrate;

forming a second code electrode portion on the inner surface of the lower insulating substrate such that one end thereof is connected to an intermediate conductive portion of a spacer and an other end thereof is connected to a socket terminal of a measuring device;

fixing a reagent reaction layer on the inner surface of the lower insulating substrate along a sample path to be in contact with the working electrode and the reference electrode;

forming a first code electrode portion, which is in contact with the reagent reaction layer, on an inner surface of an upper insulating substrate;

forming a code pattern portion by pattering a specific region of the first code electrode portion, which is in contact with the reagent reaction layer, according to a code assigned to a corresponding biosensor based on sensor information;

fixing the intermediate conductive portion on the spacer; and

assembling the upper insulating substrate with the lower insulating substrate with the spacer interposed therebetween to form the sample path such that the intermediate conductive portion of the spacer connects the first code electrode portion and the second code electrode portion,

wherein the code pattern portion is patterned by removing a predetermined area of the first code electrode portion such that the contact area with the reagent reaction layer, in which reaction current flows, differs according to the assigned code.

17. The method of claim 16, wherein, in forming the code pattern portion, the predetermined area of the first code electrode portion is ablated by irradiating a laser beam onto the inner surface of the upper insulating substrate.

18. The method of claim 16, wherein, in forming the code pattern portion, the predetermined area of the first code electrode portion is ablated together with the upper insulating substrate by irradiating a laser beam onto an outer surface of the upper insulating substrate.

19. A method for obtaining sensor information on a biosensor, the method comprising:

providing the biosensor of;

applying working voltage to the working electrode and injecting the sample into the sample path after the biosensor is inserted into the measuring device; and

obtaining sensor information on the biosensor based on electrical signals output from the working electrode and the code electrode.

20. The method of claim 19, wherein the biosensor further comprises a sensing electrode for determining a sample filled state in the sample path, and the measuring device obtains the sensor information when the measuring device determines the sample filled state from an electrical signal output from the sensing electrode for determining the sample filled state.