WO2011027979A2 - Biodétecteur capable de reconnaître automatiquement des codes et procédé de reconnaissance de code l'utilisant - Google Patents

Biodétecteur capable de reconnaître automatiquement des codes et procédé de reconnaissance de code l'utilisant Download PDF

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Publication number
WO2011027979A2
WO2011027979A2 PCT/KR2010/005254 KR2010005254W WO2011027979A2 WO 2011027979 A2 WO2011027979 A2 WO 2011027979A2 KR 2010005254 W KR2010005254 W KR 2010005254W WO 2011027979 A2 WO2011027979 A2 WO 2011027979A2
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WO
WIPO (PCT)
Prior art keywords
recognition
biosensor
sensed
code
working
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PCT/KR2010/005254
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English (en)
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WO2011027979A3 (fr
Inventor
In Hwan Choi
Jeongin Bag
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Philosys Co., Ltd.
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Publication date
Application filed by Philosys Co., Ltd. filed Critical Philosys Co., Ltd.
Publication of WO2011027979A2 publication Critical patent/WO2011027979A2/fr
Publication of WO2011027979A3 publication Critical patent/WO2011027979A3/fr

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    • GPHYSICS
    • G01MEASURING; TESTING
    • G01NINVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
    • G01N27/00Investigating or analysing materials by the use of electric, electrochemical, or magnetic means
    • G01N27/26Investigating or analysing materials by the use of electric, electrochemical, or magnetic means by investigating electrochemical variables; by using electrolysis or electrophoresis
    • G01N27/28Electrolytic cell components
    • G01N27/30Electrodes, e.g. test electrodes; Half-cells
    • G01N27/327Biochemical electrodes, e.g. electrical or mechanical details for in vitro measurements
    • GPHYSICS
    • G01MEASURING; TESTING
    • G01NINVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
    • G01N35/00Automatic analysis not limited to methods or materials provided for in any single one of groups G01N1/00 - G01N33/00; Handling materials therefor
    • G01N35/00584Control arrangements for automatic analysers
    • G01N35/00722Communications; Identification
    • G01N35/00732Identification of carriers, materials or components in automatic analysers
    • CCHEMISTRY; METALLURGY
    • C12BIOCHEMISTRY; BEER; SPIRITS; WINE; VINEGAR; MICROBIOLOGY; ENZYMOLOGY; MUTATION OR GENETIC ENGINEERING
    • C12QMEASURING OR TESTING PROCESSES INVOLVING ENZYMES, NUCLEIC ACIDS OR MICROORGANISMS; COMPOSITIONS OR TEST PAPERS THEREFOR; PROCESSES OF PREPARING SUCH COMPOSITIONS; CONDITION-RESPONSIVE CONTROL IN MICROBIOLOGICAL OR ENZYMOLOGICAL PROCESSES
    • C12Q1/00Measuring or testing processes involving enzymes, nucleic acids or microorganisms; Compositions therefor; Processes of preparing such compositions
    • C12Q1/001Enzyme electrodes
    • GPHYSICS
    • G01MEASURING; TESTING
    • G01NINVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
    • G01N27/00Investigating or analysing materials by the use of electric, electrochemical, or magnetic means
    • G01N27/26Investigating or analysing materials by the use of electric, electrochemical, or magnetic means by investigating electrochemical variables; by using electrolysis or electrophoresis
    • GPHYSICS
    • G01MEASURING; TESTING
    • G01NINVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
    • G01N33/00Investigating or analysing materials by specific methods not covered by groups G01N1/00 - G01N31/00
    • G01N33/48Biological material, e.g. blood, urine; Haemocytometers
    • GPHYSICS
    • G01MEASURING; TESTING
    • G01NINVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
    • G01N33/00Investigating or analysing materials by specific methods not covered by groups G01N1/00 - G01N31/00
    • G01N33/48Biological material, e.g. blood, urine; Haemocytometers
    • G01N33/483Physical analysis of biological material
    • G01N33/487Physical analysis of biological material of liquid biological material
    • G01N33/4875Details of handling test elements, e.g. dispensing or storage, not specific to a particular test method
    • G01N33/48771Coding of information, e.g. calibration data, lot number

Definitions

  • the present invention relates, in general, to a biosensor capable of automatically recognizing codes, which is used to analyze a biomaterial, and a code recognition method using the biosensor, and, more particularly, to a biosensor capable of automatically recognizing codes, to which a separate electrode is added and in which a variety of codes are generated based on the shapes of specific parts of the electrode, and a code recognition method using the biosensor.
  • a biosensor refers to a device which investigates the properties of a material using some functions that the living creature has. Since a biosensor uses a biomaterial as a probe device, it has high sensitivity and excellent reaction specificity. Accordingly, such biosensors are widely used in a variety of fields, such as the medical and medicine fields (the clinical treatment and chemical analysis fields), the field of the process measurement of the bioindustry, the environmental measurement field, and the field of chemical safety assessment. The range of the use of biosensors is becoming wider. In particular, in the medical diagnosis field, biosensors are widely used to analyze biosamples including blood. Biosensors are classified into enzyme analysis biosensors and immunoassay biosensors according to the type of probe device, and are classified into optical biosensors and electrochemical biosensors according to the method of quantitatively analyzing a target material contained in a biosample.
  • Enzyme analysis biosensors use specific reactions between enzymes and substrates or between enzymes and enzyme inhibitors, while immunoassay biosensors use specific reactions between antigens and antibodies. Accordingly, since they can be conveniently applied, have high measurement sensitivity and can acquire rapid results, they are most widely used in hospitals and in clinical chemical analysis. In particular, for onsite diagnosis and tests, it is possible to immediately and quantitatively analyze target materials using disposable biosensors and small-sized biosensor measuring devices.
  • Optical biosensors are biosensors which measure the concentrations of target materials by measuring the variations in transparency, absorbance or wavelength, and these are the most commonly used type of biosensors.
  • Optical biosensors have the advantage of having small deviations regarding measuring time because the reaction mechanisms of various materials to be analyzed have been already found and measurement is performed after reactions have been performed during sufficient times.
  • optical biosensors have the disadvantages of requiring long measurement times and large quantities of samples, producing measurement results influenced by the turbidities of samples, and having difficulties reducing the sizes of optical units, compared with electrochemical biosensors.
  • Electrochemical biosensors are biosensors which measure the concentrations of target materials by measuring electrical signals acquired from reactions. Electrochemical biosensors have the advantages of amplifying signals using extremely small amounts of samples, being formed in small sizes, stably acquiring measurement signals, and being easily compatible with information and communication devices.
  • a measurement method using an electrochemical biosensor is configured such that an enzyme and an adjustment reagent are fixed to a cell including an anode and a cathode.
  • oxygen or an electron transfer mediator is reduced when a target material in the sample is oxidized by the catalytic action of the enzyme. Furthermore, the reduced oxygen or electron transfer mediator is oxidized by the voltage between the electrodes, thereby causing the variation in electrons.
  • a method of indirectly measuring the amount of target material by quantifying the variation in the electrons is an electrochemical measurement method.
  • a biosensor is inserted into the measuring device first.
  • the measuring device senses the insertion of the biosensor and analyzes a target material.
  • a correction code programmed in the measuring device must be selected, and information about a target material to be analyzed by the inserted biosensor must be provided.
  • conventional biosensors and measuring devices have used a method of deforming biosensor structures or electrodes or a method of users directly inputting information to the measuring devices. Thereafter, a method of providing information about a target material by inserting a code into a biosensor has been used.
  • the conventional biosensors using codes are problematic in that with regard to the provision of information about the types of the biosensors and determination materials, the fabrication of the biosensors and the related devices is difficult because the structures of the biosensor themselves and the socket parts of the measuring devices into which the biosensors are inserted must be complicated and sophisticated when the numbers of codes desired by users increase.
  • an object of the present invention is to provide a biosensor capable of automatically recognizing codes, which is provided with an electrode for acquiring signals intended for the measurement of a biomaterial and which can automatically recognize the code of the biomaterial based on the shape of the electrode, and a code recognition method using the biosensor.
  • the present invention provides a biosensor capable of automatically recognizing codes, including a base film; an electrode unit provided on one surface or each of two surfaces of the base film; an intermediate layer coated with an enzyme material and configured to receive a biomaterial; and a closing layer provided over the intermediate layer; wherein the electrode unit includes a reaction part for acquiring a signal from the biomaterial and a code recognition electrode part for automatically recognizing a code of the biomaterial when it is inserted into a measuring device.
  • the code recognition electrode part may include a working part configured to be sensed by a sensing unit provided on one side of the measuring device when the biosensor is inserted into the measuring device, and provided with elements each for determining whether a signal has been sensed; a recognition part configured to be sensed successively after the sensing unit of the measuring device has sensed the elements of the working part, and provided with elements for generating code signals; an approval part provided so that whether preparation for measurement of the biomaterial injected into the biosensor has been completed is sensed by the sensing unit; and a reference part provided between the working part and the recognition part, and configured to transmit information about the biomaterial.
  • the code may be determined by determining each code signal using 2 n-N for "1" and summing the values.
  • the recognition and working parts of the code recognition electrode part may have an equal number of elements, and, if the recognition part has n elements, 2 n codes can be generated by selectively cutting away the elements of the working part.
  • a specific element of the working part may be cut away to prevent the code signal from being activated from the specific element of the recognition part.
  • Elements indicating a start and end of the code signal may be provided on both ends of the working and recognition parts.
  • signals from the working and recognition parts may be simple signals between a high H level and a low L level
  • the start of the code signal may be identified if a signal of the recognition part is high H and a signal of the working part switches from a high H level to a low L level
  • the end of the code signal may be identified if a signal of the working part switches from a low L level to a high H level
  • the biosensor may be determined to have been inserted if a separate recognition part has been sensed.
  • the start and end of the code signal may be determined and directions of insertion and discharge of the biosensor may be sensed, using intervals between signals generated from the plurality of recognition parts.
  • the biosensor capable of automatically recognizing codes and the code recognition method using the biosensor according to the present invention is advantageous in that a separate electrode is added to the inside of the biosensor, so that a variety of codes can be generated based on the shapes of the electrodes, with the result that the structure of the socket part of a measuring device into which the biosensor is inserted is simplified. Furthermore, they are advantageous in that in accordance with the increase in the number of elements 'n' based on the length of the biosensor, 2 n codes of biomaterials can be generated.
  • FIG. 1 is a perspective view showing a biosensor capable of automatically recognizing a code according to an embodiment of the present invention
  • FIG. 2 is an exploded perspective view showing the biosensor of FIG. 1;
  • FIG. 3 is a plan view showing the biosensor of FIG. 1;
  • FIG. 4 is a view showing a process in which the biosensor of FIG. 1 passes through a measuring device
  • FIG. 6 is a signal flowchart of the working part and recognition part of the code recognition electrode part of FIG. 1;
  • FIG. 7 is a drawing showing code signal data when elements indicating the start and end of a code signal have been added to the working part and recognition part of FIG. 6;
  • FIG. 8 is a drawing showing code signal data when recognition parts COUNT 1 and 2 are additionally provided to FIG. 6 to enable directionality to be recognized;
  • FIG. 9 is a flowchart of a code recognition method using the biosensor capable of automatically recognizing codes according to the present invention.
  • a biosensor capable of automatically recognizing a code and a method of recognizing a code using the biosensor according to embodiments of the present invention will be described with reference to the accompanying drawings in detail below.
  • FIG. 1 is a perspective view showing a biosensor capable of automatically recognizing a code according to an embodiment of the present invention
  • FIG. 2 is an exploded perspective view showing the biosensor of FIG. 1
  • FIG. 3 is a plan view showing the biosensor of FIG. 1.
  • the biosensor 100 capable of automatically recognizing a code shown in FIGS. 1 to 3 will now be described in detail.
  • the biosensor 100 comprises a base film 110, an electrode unit 120, an intermediate layer 150, and a closing layer 160.
  • the base film 110 functions as a base support for the biosensor 100.
  • the electrode unit 120 is disposed on one or both surfaces of the base film 110, and includes a reaction part 130 for acquiring a signal from a biomaterial and a code recognition electrode part 140 capable of automatically recognizing the code of a biomaterial when it is inserted into a measuring device (not shown).
  • the intermediate layer 150 covers the electrode unit 120, is coated with enzyme material, and is provided with an injection cutout 155 on one side thereof so that a biomaterial is injected therethrough.
  • the closing layer 160 is provided over the intermediate layer 150, and is provided with a bent hole 165 through which internal air is discharged with biomaterial is injected.
  • the base film 110, the intermediate layer 150 and/or the closing layer 160 may be formed of plastic, polyester, polypropylene and/or polycarbonate-based polymer material, ceramic, glass, and/or a PET film.
  • the code recognition electrode part 140 includes a working part WORKING 142 configured to be sensed by a sensing unit (not shown) provided on one side of a measuring device when the biosensor 100 is inserted into the measuring device, and provided with elements each for determining whether a signal has been sensed, a recognition part COUNT 146 configured to be sensed successively after the sensing unit of the measuring device has sensed the elements of the working part 142, and provided with elements for generating code signals, an approval part RECOG 148 provided so that whether the preparation for the measurement of the biomaterial injected into the biosensor 100 has been completed is sensed by the sensing unit, and a reference part GND 144 provided between the working part 142 and the recognition part 146, and configured to transmit information about the biomaterial.
  • FIG. 4 is a view showing a process in which the biosensor 100 of FIG. 1 passes through a measuring device
  • FIG. 6 is a signal flowchart of the working part 142 and recognition part 146 of the code recognition electrode part 140 of FIG. 1.
  • each code signal is designated by Cn. Since in FIG. 4, the number of elements is four, code signals are denoted by C1 to C4.
  • a line K of FIG. 4 is a sensing line which senses the biosensor in the sensing unit of the measuring device. Recognition is performed while the biosensor is moving forward from the line K. Referring to FIG. 4, when the biosensor is not in contact with the sensing line K, any code is not read. Thereafter, when the first element of the working part 142 inserted into the measuring device is sensed by the sensing line K of the sensing unit as the biosensor moves forward, the sensing of the signal of the recognition part 146 is enabled and, thus, the first element of the recognition part 146 is successively sensed, so that a code signal is generated. In this case, a code signal C1 is determined to be "1".
  • codes which can be generated are illustrated.
  • the working part 142 and the recognition part 146 have the same number of elements.
  • This drawing indicates that if the recognition part 146 has 'n' elements, 2 n codes can be generated by selectively cutting away the elements of the working part 142. Since in FIG. 5, 'n' is 4, codes to be generated are 0 to 15, that is, a total of 16 codes, if a value is recognized as "1" when the working part 142 and the recognition part 146 are sensed. In the same manner, if a code signal value is recognized as "1" when the working part 142 and the recognition part 146 are not sensed, codes to be generated are 0 to 15, that is, a total of 16 codes.
  • FIG. 6 is a signal flowchart of the working part 142 and recognition part 146 of the code recognition electrode part 140.
  • an element of the working part 142 is sensed by the sensing unit, in which case a simple signal based on a line A is generated (indicated by the two-dot chain lines).
  • a corresponding element of the recognition part 146 is sensed by the sensing unit, in which case a simple signal based on a line B is generated (indicated by dotted lines).
  • the simple signal based on the line B is a code signal, and the rising value thereof is determined to be "1".
  • a rising value may be determined to be "0".
  • a code signal value may be determined to be "1" and then a code may be determined.
  • the front elements of the working part 142 and recognition part 146 of the code recognition electrode part 140 are spaced apart from each other by a predetermined interval "C". Thanks to the distance in location, that is, the interval "C", sensed by the sensing unit of the measuring device, when the recognition part 146 is sensed, the working part 142 is guaranteed to remain in secure contact.
  • the interval "C" is provided.
  • FIG. 7 shows code signal data when elements indicating the start and end of a code signal when the code signal is input have been added. That is, when the biosensor is inserted, the status of the signal of the working part 'working' is checked at the start and at the end, that is, two positions where the signal of the recognition part 'count' rises to a high H level or falls to a low L level.
  • the signal of the recognition part 'count' is high H and the signal of the working part 'working' is high H and then becomes low L
  • the start of the code signal is indicated.
  • the signal of the recognition part 'count' is high H and the signal of the working part 'working' is low L and then becomes high H
  • the end of the code signal is indicated.
  • the approval part 148 since the same signal is generated when the biosensor is discharged, the approval part 148 must be provided to prevent the confusion of the direction of insertion. That is, in the case of discharge, when the signal of the recognition part 'count' is high H, the signal of the working part working switches from a high H level to a low L level at the end, and the signal of the working part 'working' switches from a low L level to a high H level, so that it may be confused with the case of insertion. Accordingly, in order to prevent this, the approval part 148 must be provided. The start and end of the code signal may be set in the opposite manner.
  • the first and last code signals can be sensed using the above method, and the sensing of the first signal and the subsequent second signal is enabled. As a result, it can be seen that even when a code signal generated after the second code signal is inappropriate, that is, even when the direction of insertion or discharge has varied, the first and second code signals and the last code signal are guaranteed to be always uniform.
  • FIG. 8 is a diagram showing code signal data when a working part 'working' and recognition parts 'count 1' and 'count 2' are provided.
  • the directions of insertion and discharge of the biosensor 100 are sensed based on the intervals K1 and K2 between the signals of the recognition parts count 1 and count 2. That is, when the signal of the recognition part count 1 is activated at a location away from the signal of the recognition part count 2 by the interval K1, the biosensor may be determined to be inserted. When the signal of the recognition part count 2 is activated at a location away from the signal of the recognition part count 1 by the interval K2, the biosensor may be determined to be discharged. K1 and K2 are predetermined intervals. The directions of the insertion and discharge of the biosensor can be sensed based on the intervals between the activations of the signals of the recognition parts count 1 and count 2.
  • the start and end of the elements can be clearly sensed by adding elements to the recognition part COUNT and the working part 'working' and the direction of insertion and discharge can be sensed by providing the approval part RECOG or by using a plurality of recognition part signals.
  • FIG. 9 is a flowchart of a code recognition method using the biosensor capable of automatically recognizing codes according to the present invention.
  • the biosensor 100 capable of automatically recognizing codes and the code recognition method using the biosensor 100, it is possible to generate a variety of codes based on the shapes of the elements of the electrode without requiring the addition of a separate pin into the biosensor 100, so that the structure of the socket part of a measuring device into which the biosensor 100 is inserted is simplified. Furthermore, they are advantageous in that in accordance with the increase in the number of elements 'n' based on the length of the biosensor, 2 n codes of biomaterials can be generated.

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Abstract

La présente invention porte sur un biodétecteur capable de reconnaître automatiquement des codes et sur un procédé de reconnaissance de code utilisant le biodétecteur. Le biodétecteur comprend un film de base, une unité d'électrode disposée sur une surface ou sur chacune des deux surfaces du film de base, une couche intermédiaire revêtue d'une matière enzymatique et configurée pour recevoir une biomatière, et une couche de fermeture disposée sur la couche intermédiaire. L'unité d'électrode comprend une partie réaction pour acquérir un signal à partir de la biomatière et une partie électrode de reconnaissance de code pour reconnaître automatiquement un code de la biomatière lorsqu'elle est introduite dans un dispositif de mesure.
PCT/KR2010/005254 2009-09-04 2010-08-11 Biodétecteur capable de reconnaître automatiquement des codes et procédé de reconnaissance de code l'utilisant WO2011027979A2 (fr)

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KR10-2009-0083246 2009-09-04
KR1020090083246A KR101033649B1 (ko) 2009-09-04 2009-09-04 자동코드인식을 위한 바이오센서 및 이를 이용한 코드인식방법

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WO2011027979A3 WO2011027979A3 (fr) 2011-04-28

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Cited By (1)

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CN108931567A (zh) * 2017-05-24 2018-12-04 菲诺西思生物科技有限公司 提供自动识别的代码序列的测试条及活体物质检测装置

Families Citing this family (2)

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KR101489600B1 (ko) * 2013-11-11 2015-02-04 주식회사 필로시스 자동코딩을 위한 바이오센서
KR102092325B1 (ko) * 2017-05-24 2020-03-23 주식회사 필로시스 자동으로 인식되는 코드 시퀀스를 제공하는 테스트 스트립 및 생체 물질 측정 장치

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JP2003149192A (ja) * 2001-08-29 2003-05-21 F Hoffmann La Roche Ag バイオセンサー
KR20080053328A (ko) * 2005-09-02 2008-06-12 아크레이 인코퍼레이티드 시료공급상태의 검출 방법 및 분석 용구
JP2009008574A (ja) * 2007-06-29 2009-01-15 Sumitomo Electric Ind Ltd センサチップ及びバイオセンサカートリッジ並びにバイオセンサ装置
KR100918027B1 (ko) * 2009-02-19 2009-09-18 주식회사 올메디쿠스 코드전극을 구비한 바이오센서와 이의 제조방법, 및 이의 센서 정보 획득 방법

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Publication number Priority date Publication date Assignee Title
JP2003149192A (ja) * 2001-08-29 2003-05-21 F Hoffmann La Roche Ag バイオセンサー
KR20080053328A (ko) * 2005-09-02 2008-06-12 아크레이 인코퍼레이티드 시료공급상태의 검출 방법 및 분석 용구
JP2009008574A (ja) * 2007-06-29 2009-01-15 Sumitomo Electric Ind Ltd センサチップ及びバイオセンサカートリッジ並びにバイオセンサ装置
KR100918027B1 (ko) * 2009-02-19 2009-09-18 주식회사 올메디쿠스 코드전극을 구비한 바이오센서와 이의 제조방법, 및 이의 센서 정보 획득 방법

Cited By (4)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN108931567A (zh) * 2017-05-24 2018-12-04 菲诺西思生物科技有限公司 提供自动识别的代码序列的测试条及活体物质检测装置
EP3415907A3 (fr) * 2017-05-24 2019-03-06 Philosys Co., Ltd. Bande d'essai fournissant une séquence de code à reconnaître automatiquement et dispositif de surveillance d'analyte biologique
US10739296B2 (en) 2017-05-24 2020-08-11 Philosys Co., Ltd. Test strip providing code sequence to be automatically recognized, and biological analyte monitoring device
CN108931567B (zh) * 2017-05-24 2023-02-28 菲诺西思生物科技有限公司 提供自动识别的代码序列的测试条及活体物质检测装置

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WO2011027979A3 (fr) 2011-04-28
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