JP2008304197A - Biosensor - Google Patents

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JP2008304197A
JP2008304197A JP2007148927A JP2007148927A JP2008304197A JP 2008304197 A JP2008304197 A JP 2008304197A JP 2007148927 A JP2007148927 A JP 2007148927A JP 2007148927 A JP2007148927 A JP 2007148927A JP 2008304197 A JP2008304197 A JP 2008304197A
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detection
working electrode
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measurement
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JP4856011B2 (en
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Hideki Tanaka
田中秀樹
Kazuhiko Ishio
石尾和彦
Hideki Sato
佐藤秀樹
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Gunze Ltd
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Abstract

<P>PROBLEM TO BE SOLVED: To provide a biosensor capable of easily recognizing whether sample blood or the like is deposited on the biosensor as a spot. <P>SOLUTION: The biosensor 10 is equipped with a substrate 12, a measuring working electrode 14 provided on the substrate 12, a measuring counter electrode 16 provided on the substrate 12 so as to leave a definite interval with respect to the working electrode 14, a reaction part 18 provided on the measuring working electrode 14 and the measuring counter electrode 16, a supply port 20 for introducing blood (specimen) into the reaction part 18, a sensing working electrode 22 provided on the substrate 12, a sensing counter electrode 24 provided on the substrate 12 so as to leave a definite interval with respect to the sensing working electrode 22, sensing working electrode 50 for spot deposition provided on the substrate 12 and a sensing counter electrode 52 for spot deposition provided on the substrate 12 so as to leave a definite interval with respect to the sensing working electrode 50 for spot deposition. <P>COPYRIGHT: (C)2009,JPO&INPIT

Description

本発明は、検体中の特定成分量を測定することによって定量分析できるバイオセンサに関する。   The present invention relates to a biosensor capable of quantitative analysis by measuring the amount of a specific component in a specimen.

従来から、検体の血糖値等を測定するバイオセンサが案出されている(例えば、特許文献1及び特許文献2参照。)。このバイオセンサによれば、供給口から導入された血液等に反応部が反応した時の測定用作用電極及び測定用対向電極間の電流値を測定することにより、血糖値等を測定できる。   Conventionally, biosensors have been devised for measuring blood sugar levels and the like of specimens (see, for example, Patent Document 1 and Patent Document 2). According to this biosensor, a blood glucose level or the like can be measured by measuring a current value between the measurement working electrode and the measurement counter electrode when the reaction part reacts with blood or the like introduced from the supply port.

しかし、採取する血液等の量は僅かであるため、従来のバイオセンサによれば、採取した血液等がバイオセンサに点着されたか否かを肉眼で確認するのは困難であった。また、採取した血液等の量が不十分であること等により、反応部まで導入された血液等の量が少ないために、正確な測定を行うことができないことがあった。すなわち、反応部まで導入された血液の量が正確な測定に必要な量でないにもかかわらずに、血糖値等を測定出力することにより、不正確な測定値を正確な測定値と認識してしまうことがあった。 However, since the amount of blood and the like collected is small, it has been difficult for the conventional biosensor to confirm with the naked eye whether or not the collected blood or the like has been spotted on the biosensor. In addition, due to an insufficient amount of collected blood or the like, the amount of blood or the like introduced to the reaction part is small, so that accurate measurement may not be performed. In other words, even though the amount of blood introduced to the reaction part is not necessary for accurate measurement, the blood glucose level is measured and output, thereby recognizing an inaccurate measurement value as an accurate measurement value. There was a case.

特公平8−10208号公報Japanese Patent Publication No.8-10208 国際公開第2004/017057号パンフレットInternational Publication No. 2004/017057 Pamphlet

そこで、本発明者は、このような課題の原因を究明してこのような課題を解決するべく、鋭意研究を重ねた結果、本発明に至ったのである。   Therefore, the inventor of the present invention has come to the present invention as a result of intensive studies to investigate the cause of such a problem and solve such a problem.

すなわち、本発明は、採取した血液等がバイオセンサに点着されたか否かを容易に認識できるとともに、反応部まで導入された血液等の量が正確な測定に必要な量であるか否かを正確に検知することのできるバイオセンサを提供することを目的とする。   That is, the present invention can easily recognize whether or not collected blood or the like is spotted on the biosensor, and whether or not the amount of blood or the like introduced to the reaction part is an amount necessary for accurate measurement. It is an object of the present invention to provide a biosensor that can accurately detect the odor.

本発明のバイオセンサは、絶縁体から成る基板と、該基板上に設けられた測定用作用電極と、該基板上に該測定用作用電極と一定間隔を空けて設けられた測定用対向電極と、該測定用作用電極及び該測定用対向電極上に設けられた反応部と、検体を該反応部まで導入する供給口と、を備え、前記反応部が前記供給口から導入された検体中の特定成分と反応し、該特定成分を定量分析するバイオセンサにおいて、前記測定用作用電極及び前記測定用対向電極に対して前記供給口と反対側において、前記基板上に、前記導入された検体を検出する検出用電極を備え、前記測定用作用電極及び前記測定用対向電極に対して前記供給口側において、前記基板上に設けられた点着検知用作用電極と、該基板上に該点着検知用作用電極と一定間隔を空けて設けられた点着検知用対向電極と、を備え、前記検出用電極、前記点着検知用作用電極及び前記点着検知用対向電極によって前記検体の導入を検知することを特徴とする。 The biosensor of the present invention includes a substrate made of an insulator, a measurement working electrode provided on the substrate, and a measurement counter electrode provided on the substrate at a predetermined interval from the measurement working electrode. A reaction part provided on the measurement working electrode and the measurement counter electrode, and a supply port for introducing the specimen to the reaction part, wherein the reaction part is contained in the specimen introduced from the supply port. In the biosensor that reacts with a specific component and quantitatively analyzes the specific component, the introduced specimen is placed on the substrate on the side opposite to the supply port with respect to the measurement working electrode and the measurement counter electrode. And a spotting detection working electrode provided on the substrate on the supply port side with respect to the measurement working electrode and the measurement counter electrode, and the spotting on the substrate. A certain distance from the detection working electrode And a wear detection counter electrode that has been kicked, the detection electrode, and detecting the introduction of the sample by the spotting detecting working electrode and the spotting detection counter electrode.

また、本発明のバイオセンサは、前記バイオセンサにおいて、前記反応部が、前記点着検知用作用電極及び点着検知用対向電極に接触することを特徴とする。   Moreover, the biosensor of the present invention is characterized in that, in the biosensor, the reaction section is in contact with the working electrode for spotting detection and the counter electrode for spotting detection.

また、本発明のバイオセンサは、前記バイオセンサにおいて、前記反応部が前記供給口から導入された検体に反応した時の前記点着検知用作用電極及び点着検知用対向電極間の電流値を検知して、該検体の導入を検知することを特徴とする。   In the biosensor of the present invention, in the biosensor, the current value between the spotting detection working electrode and the spotting detection counter electrode when the reaction unit reacts to the sample introduced from the supply port is calculated. And detecting the introduction of the specimen.

また、本発明のバイオセンサは、前記バイオセンサにおいて、前記検出用電極が、前記基板上に設けられた検出用作用電極と、該基板上に該検出用作用電極と一定間隔を空けて設けられた検出用対向電極と、を含むことを特徴とする。   In the biosensor of the present invention, in the biosensor, the detection electrode is provided on the substrate with a detection working electrode, and the detection working electrode is provided on the substrate at a predetermined interval. And a counter electrode for detection.

本発明のバイオセンサによれば、点着検知用作用電極及び点着検知用対向電極によって検体の供給口への点着を検知することができる。このため、採取した血液等がバイオセンサに点着されたか否かを容易に認識できる。また、検体の供給口への点着を条件として、検出用電極により反応部まで導入された血液等の量が正確な測定に必要な量であるか否かの検出を開始できる。これにより、導入された血液等の量が正確な測定に必要な量であるか否かを正確に検知できる。   According to the biosensor of the present invention, it is possible to detect the spotting of the specimen to the supply port using the spotting detection working electrode and the spotting detection counter electrode. For this reason, it can be easily recognized whether the collected blood or the like has been spotted on the biosensor. In addition, on the condition that the specimen is spotted on the supply port, it is possible to start detecting whether or not the amount of blood or the like introduced to the reaction part by the detection electrode is an amount necessary for accurate measurement. Thereby, it is possible to accurately detect whether or not the amount of introduced blood or the like is an amount necessary for accurate measurement.

次に、本発明に係るバイオセンサについて、図面に基づいて詳しく説明する。図1及び図2において、符号10は本発明のバイオセンサを示す。   Next, the biosensor according to the present invention will be described in detail based on the drawings. 1 and 2, reference numeral 10 denotes a biosensor of the present invention.

本発明のバイオセンサ10は、絶縁体から成る基板12と、基板12上に設けられた測定用作用電極14と、基板12上に測定用作用電極14と一定間隔を空けて設けられた測定用対向電極16と、測定用作用電極14及び測定用対向電極16上に設けられた反応部18と、血液(検体)を反応部18まで導入する供給口20と、を備え、反応部18が供給口20から導入された血液中の特定成分と反応し、特定成分を定量分析するバイオセンサである。このバイオセンサ10において、測定用作用電極14及び測定用対向電極16に対して供給口20と反対側において、基板12上に設けられた検出用作用電極22と、基板12上に検出用作用電極22と一定間隔を空けて設けられた検出用対向電極24と、測定用作用電極14及び測定用対向電極16に対して供給口側20において、基板12上に設けられた点着検知用作用電極50と、基板12上に点着検知用作用電極50と一定間隔を空けて設けられた点着検知用対向電極52と、を備え、検出用作用電極22、検出用対向電極24、点着検知用作用電極50及び点着検知用対向電極52によって血液の導入を検知するように構成されている。よって、検出用作用電極22及び検出用対向電極24が検出用電極を構成する。 The biosensor 10 of the present invention includes a substrate 12 made of an insulator, a measurement working electrode 14 provided on the substrate 12, and a measurement working electrode 14 provided on the substrate 12 with a predetermined interval. A counter electrode 16, a measurement working electrode 14, a reaction part 18 provided on the measurement counter electrode 16, and a supply port 20 for introducing blood (specimen) to the reaction part 18, are supplied by the reaction part 18. It is a biosensor that reacts with a specific component in blood introduced from the mouth 20 and quantitatively analyzes the specific component. In this biosensor 10, the detection working electrode 22 provided on the substrate 12 and the detection working electrode on the substrate 12 on the side opposite to the supply port 20 with respect to the measurement working electrode 14 and the measurement counter electrode 16. 22, a counter electrode for detection 24 provided at a predetermined interval, and a working electrode for spotting detection provided on the substrate 12 on the supply port side 20 with respect to the measurement working electrode 14 and the measurement counter electrode 16 50, a spotting detection working electrode 50 on the substrate 12 and a spotting detection counter electrode 52 provided at a predetermined interval, and a detection working electrode 22, a detection counter electrode 24, and spotting detection. The introduction of blood is detected by the working electrode 50 and the counter electrode 52 for spotting detection. Therefore, the detection working electrode 22 and the detection counter electrode 24 constitute a detection electrode.

基板12を構成する絶縁体は、例えば、ポリエチレンテレフタレート(PET)、ポリエチレンナフタレート、脂肪族ユニット及び芳香族ユニットからなる生分解性ポリエステル樹脂等のポリエステル系樹脂シート、より耐熱性、耐薬品性、強度等に優れるポリアミドイミドシート、ポリイミドフィルムシート等のプラスチックシート、セラミック等の無機系基板等である。 The insulator constituting the substrate 12 is, for example, polyethylene terephthalate (PET), polyethylene naphthalate, a polyester resin sheet such as a biodegradable polyester resin composed of an aliphatic unit and an aromatic unit, more heat resistance, chemical resistance, Examples thereof include a polyamideimide sheet having excellent strength, a plastic sheet such as a polyimide film sheet, and an inorganic substrate such as ceramic.

測定用作用電極14及び測定用対向電極16は、夫々略半円形状に構成され、両者によって一つの略円形状を構成する。測定用作用電極14及び測定用対向電極16は、電気絶縁基板12上に、例えば白金、金、パラジウム、インジウム−スズ酸化物等の良電導体によって形成される。形成方法としては、ホットスタンピングなどが考えられるが、真空蒸着又はスパッタリングによる方法が微細な電極パターンを精度良く形成できるので好ましい。スパッタリングの場合は、両電極形成外をマスキングすることで一挙に形成できる。   The measuring working electrode 14 and the measuring counter electrode 16 are each formed in a substantially semicircular shape, and both form a substantially circular shape. The measuring working electrode 14 and the measuring counter electrode 16 are formed on the electrically insulating substrate 12 by a good conductor such as platinum, gold, palladium, indium-tin oxide, or the like. As a forming method, hot stamping or the like can be considered, but a method by vacuum deposition or sputtering is preferable because a fine electrode pattern can be formed with high accuracy. In the case of sputtering, it can be formed at once by masking the outside of the formation of both electrodes.

反応部18は、酸化還元酵素及び電子受容体を含んで構成される。例えば、酸化還元酵素及び電子受容体を含む液体状の材料を塗布して乾燥させることにより構成される。酸化還元酵素は、例えば、グルコースを測定する場合には、グルコースオキシダーゼが挙げられる。グルコースオキシダーゼは、グルコースと反応して、グルコン酸及び過酸化水素が生成する。また、アルコール値を測定する場合には、アルコールオキシダーゼ又はアルコールデヒドロゲナーゼを使用する。また、乳酸を測定する場合には、乳酸オキシダーゼ又は乳酸デヒドロゲナーゼを使用する。また、尿酸を測定する場合には、ウリカーゼを使用する。電子受容体としては、例えば、フェリシアン化アルカリ金属塩(特にフェリシアン化カリウム金属塩が好ましい。)、フェロセン又はそのアルキル置換体、p−ベンゾキノン、メチレンブルー、β−ナフトキノン−4−スルホン酸カリウム、フェナジンメトサルフェート、2、6−ジクロロフェノール−インドフェノール等が挙げられる。フェリシアン化アルカリ金属塩、フェロセン系が、電子移動媒体としての働きが安定しており、水、アルコール類、又はこれら混合溶媒等の水性溶媒に良く溶けるため、電子受容体として有効に作用する。   The reaction unit 18 includes an oxidoreductase and an electron acceptor. For example, it is configured by applying and drying a liquid material containing an oxidoreductase and an electron acceptor. Examples of the oxidoreductase include glucose oxidase when measuring glucose. Glucose oxidase reacts with glucose to produce gluconic acid and hydrogen peroxide. Moreover, when measuring an alcohol value, alcohol oxidase or alcohol dehydrogenase is used. When measuring lactic acid, lactate oxidase or lactate dehydrogenase is used. When measuring uric acid, uricase is used. Examples of the electron acceptor include alkali metal ferricyanide (particularly potassium ferricyanide metal salt), ferrocene or an alkyl-substituted product thereof, p-benzoquinone, methylene blue, potassium β-naphthoquinone-4-sulfonate, phenazine metho. Examples include sulfate, 2,6-dichlorophenol-indophenol, and the like. Ferricyanide alkali metal salts and ferrocenes have a stable function as an electron transfer medium and are well soluble in aqueous solvents such as water, alcohols, or mixed solvents thereof, and thus effectively function as electron acceptors.

供給口20は、図1に示すように、基板12上にスペーサ26を介して設けられたカバー28の先端縁31と、基板12の先端縁33とによって構成される。すなわち、スペーサ26によって先端縁31と先端縁33との間に生じた隙間によって供給口20が構成される。供給口20から導入された血液は毛細管現象によってスペーサ26の先端縁35まで到達することが可能である。   As shown in FIG. 1, the supply port 20 includes a leading edge 31 of a cover 28 provided on the substrate 12 via a spacer 26 and a leading edge 33 of the substrate 12. That is, the supply port 20 is configured by a gap generated between the leading edge 31 and the leading edge 33 by the spacer 26. The blood introduced from the supply port 20 can reach the tip edge 35 of the spacer 26 by capillary action.

検出用作用電極22及び検出用対向電極24は、図1に示すように、測定用作用電極14及び測定用対向電極16を挟みながら測定用作用電極14及び測定用対向電極16に接触しないように設けられている。検出用作用電極22の先端は、測定用作用電極14において供給口20と反対側に設けられた略半円形状の切り欠きに入り込み、検出用対向電極24の先端は、測定用作用電極14において供給口20と反対側に設けられた略半円形状の切り欠きに入り込んでいる。   As shown in FIG. 1, the detection working electrode 22 and the detection counter electrode 24 are not in contact with the measurement working electrode 14 and the measurement counter electrode 16 while sandwiching the measurement working electrode 14 and the measurement counter electrode 16. Is provided. The tip of the detection working electrode 22 enters a substantially semicircular cutout provided on the opposite side of the supply port 20 in the measurement working electrode 14, and the tip of the detection counter electrode 24 is in the measurement working electrode 14. It enters a substantially semicircular cutout provided on the side opposite to the supply port 20.

このような検出用作用電極22及び検出用対向電極24には、反応部18が接触しており、血液が検出用作用電極22及び検出用対向電極24に直接接触した時ではなく、反応部18が供給口20から導入された血液に反応した時の検出用作用電極22及び検出用対向電極24間の電流値を検知して、導入された血液の量を検出するように構成されている。なお、検出用作用電極22及び検出用対向電極24の材質は、上述の測定用作用電極14及び測定用対向電極16の材質と同様である。 The reaction part 18 is in contact with the detection working electrode 22 and the detection counter electrode 24, and not when the blood directly contacts the detection working electrode 22 and the detection counter electrode 24. Is configured to detect the amount of blood introduced by detecting the current value between the detection working electrode 22 and the detection counter electrode 24 when it reacts with blood introduced from the supply port 20. The materials of the detection working electrode 22 and the detection counter electrode 24 are the same as the materials of the measurement working electrode 14 and the measurement counter electrode 16 described above.

点着検知用作用電極50及び点着検知用対向電極52は、図1に示すように、測定用作用電極14及び測定用対向電極16の外周に沿って湾曲しながら測定用作用電極14及び測定用対向電極16に接触しないように設けられている。点着検知用作用電極50及び点着検知用対向電極52の先端は、供給口20の中央付近に位置し、通常血液が最初に点着する位置になるように構成されている。   The spotting detection working electrode 50 and the spotting detection counter electrode 52 are curved along the outer periphery of the measurement working electrode 14 and the measurement counter electrode 16 as shown in FIG. It is provided so as not to contact the counter electrode 16 for use. The tips of the spotting detection working electrode 50 and the spotting detection counter electrode 52 are located in the vicinity of the center of the supply port 20, and are configured to be positions where blood is usually spotted first.

このような点着検知用作用電極50及び点着検知用対向電極52には、反応部18が接触しており、血液が点着検知用作用電極50及び点着検知用対向電極52に直接接触した時だけではなく、反応部18が供給口20から導入された血液に反応した時の点着検知用作用電極50及び点着検知用対向電極52間の電流値を検知して、血液の導入を検出するように構成されている。なお、点着検知用作用電極50及び点着検知用対向電極52の材質は、上述の測定用作用電極14及び測定用対向電極16の材質と同様である。 The reaction unit 18 is in contact with the spotting detection working electrode 50 and the spotting detection counter electrode 52, and blood directly contacts the spotting detection working electrode 50 and the spotting detection counter electrode 52. Not only when the reaction unit 18 reacts to the blood introduced from the supply port 20, but detects the current value between the spotting detection working electrode 50 and the spotting detection counter electrode 52 to introduce blood. Is configured to detect. The materials of the spotting detection working electrode 50 and the spotting detection counter electrode 52 are the same as the materials of the measurement working electrode 14 and the measurement counter electrode 16 described above.

このバイオセンサ10は、基板12上に測定用作用電極14及び測定用対向電極16、検出用作用電極22及び検出用対向電極24、並びに点着検知用作用電極50及び点着検知用対向電極52を設け、測定用作用電極14及び測定用対向電極16、検出用作用電極22及び検出用対向電極24、並びに点着検知用作用電極50及び点着検知用対向電極52上に反応部18を塗布して、スペーサ26を介してカバー28で覆うことにより形成される。   The biosensor 10 includes a measurement working electrode 14 and a measurement counter electrode 16, a detection working electrode 22 and a detection counter electrode 24, and a spotting detection working electrode 50 and a spotting detection counter electrode 52 on a substrate 12. The reaction portion 18 is applied on the measurement working electrode 14 and the measurement counter electrode 16, the detection working electrode 22 and the detection counter electrode 24, and the spotting detection working electrode 50 and the spotting detection counter electrode 52. Then, it is formed by covering with a cover 28 via a spacer 26.

また、このようなバイオセンサ10は、血糖値を測定する時には、計測表示器30のセンサ取り付け開口部に挿入されることにより、図2に示すように、測定用作用電極14と一体の測定用作用電極端子32がスイッチ34等を介して制御手段36に接続され、測定用対向電極16と一体の測定用対向電極端子38がスイッチ40等を介して制御手段36に接続され、検出用作用電極22と一体の検出用作用電極端子42がスイッチ44等を介して制御手段36に接続され、検出用対向電極24と一体の検出用対向電極端子46がスイッチ48等を介して制御手段36に接続され、点着検知用作用電極50と一体の点着検知用作用電極端子54がスイッチ56等を介して制御手段36に接続され、点着検知用対向電極52と一体の点着検知用作用電極端子58がスイッチ60等を介して制御手段36に接続される。 In addition, when the blood glucose level is measured, such a biosensor 10 is inserted into the sensor mounting opening of the measurement display 30 so that the measurement is integrated with the measurement working electrode 14 as shown in FIG. The working electrode terminal 32 is connected to the control means 36 via the switch 34 and the like, and the measuring counter electrode terminal 38 integrated with the measuring counter electrode 16 is connected to the control means 36 via the switch 40 and the like, and the detection working electrode 22 is connected to the control means 36 via a switch 44 or the like, and the detection counter electrode terminal 46 integral with the detection counter electrode 24 is connected to the control means 36 via a switch 48 or the like. The spotting detection working electrode terminal 54 integrated with the spotting detection working electrode 50 is connected to the control means 36 via the switch 56 and the like, and is integrated with the spotting detection counter electrode 52 for spotting detection. Use the electrode terminal 58 is connected to the control unit 36 via the switch 60 and the like.

このような構成のバイオセンサ10を使用して血糖値を測定する場合の作用について以下に説明する。血糖値の測定者は、まず、バイオセンサ10を計測表示器30のセンサ取り付け開口部に挿入し、針等を指先に突刺して出た血液をバイオセンサ10の供給口20の中央部付近に点着する。供給口20の中央部付近に点着した血液は、基板12とカバー28との隙間を毛細管現象によって、反応部20に沿ってスペーサ26の先端縁35に向って流動することとなり、まず最初に、反応部18の中の供給口20側に付着する。この時、スイッチ56及び60がONとなり、スイッチ34、40、44及び48がOFFとなっており、反応部18の中の供給口20側が血液と反応することにより、又は点着検知用作用電極50及び点着検知用対向電極52間に電子の授受が生じることにより、点着検知用作用電極50及び点着検知用対向電極52間に電流が生じる。点着検知用作用電極50及び点着検知用対向電極52間に生じた電流値は、制御手段36が認識する。制御手段36は、この電流値が一定値(閾値)以上であることを認識した場合には、血液が供給口20に点着されたと判断し、スイッチ44及び48がONとなり、スイッチ34、40、56及び60がOFFとなった状態で、検出用作用電極22及び検出用対向電極24による血液の検出を開始する。なお、この点着検知用作用電極50及び点着検知用対向電極52間に生じた電流値が一定値(閾値)未満である場合には、一定値以上になるまで時間待ちを行う。   The operation of measuring the blood glucose level using the biosensor 10 having such a configuration will be described below. The blood glucose level measurer first inserts the biosensor 10 into the sensor mounting opening of the measurement display 30 and puts the blood pierced into the fingertip near the center of the supply port 20 of the biosensor 10. To spot. The blood spotted in the vicinity of the center of the supply port 20 flows through the gap between the substrate 12 and the cover 28 along the reaction portion 20 toward the tip edge 35 of the spacer 26 due to capillary action. Then, it adheres to the supply port 20 side in the reaction section 18. At this time, the switches 56 and 60 are turned on and the switches 34, 40, 44 and 48 are turned off, and the supply port 20 side in the reaction unit 18 reacts with blood, or a working electrode for spotting detection. As a result of the transfer of electrons between 50 and the spotting detection counter electrode 52, a current is generated between the spotting detection working electrode 50 and the spotting detection counter electrode 52. The controller 36 recognizes the current value generated between the spotting detection working electrode 50 and the spotting detection counter electrode 52. When the control means 36 recognizes that the current value is equal to or greater than a certain value (threshold value), the control means 36 determines that blood has been spotted on the supply port 20, and the switches 44 and 48 are turned on, and the switches 34, 40 are turned on. , 56 and 60 are turned off, and blood detection by the detection working electrode 22 and the detection counter electrode 24 is started. When the current value generated between the spotting detection working electrode 50 and the spotting detection counter electrode 52 is less than a predetermined value (threshold value), a time is waited until the current value becomes equal to or greater than the predetermined value.

検出用作用電極22及び検出用対向電極24による血液の検出を開始し、供給口20に点着した血液の量が血糖値を正確に測定するのに十分な量である場合には、反応部18の中の供給口20と反対側端部付近も血液が到達して反応すること若しくは反応部18全体に渡って十分に反応することにより、又は検出用作用電極22及び検出用対向電極24間に電子の授受が生じることにより、検出用作用電極22及び検出用対向電極24間に電流が生じる。検出用作用電極22及び検出用対向電極24間に生じた電流値は、制御手段36が認識する。制御手段36は、予め定めた一定時間内にこの電流値が一定値(閾値)以上であることを認識した場合には、血液の量が血糖値を正確に測定するのに十分な量であると判断し、スイッチ34及び40がONとなり、スイッチ44、48、56及び60がOFFとなって、測定用作用電極14及び測定用対向電極16によって測定した血糖値を表示手段に表示する。これにより、測定者は、正確な測定値であるとの認識の下に、血糖値を読み取ることができる。 When the detection of the blood by the detection working electrode 22 and the detection counter electrode 24 is started and the amount of blood spotted on the supply port 20 is sufficient to accurately measure the blood glucose level, the reaction unit 18 near the supply port 20 on the side opposite to the supply port 20, blood reaches or reacts, or reacts well over the entire reaction unit 18, or between the detection working electrode 22 and the detection counter electrode 24. As a result of the transfer of electrons, a current is generated between the detection working electrode 22 and the detection counter electrode 24. The control means 36 recognizes the current value generated between the detection working electrode 22 and the detection counter electrode 24. If the control means 36 recognizes that the current value is equal to or greater than a predetermined value (threshold value) within a predetermined time, the amount of blood is sufficient to accurately measure the blood glucose level. The switches 34 and 40 are turned on and the switches 44, 48, 56 and 60 are turned off, and the blood glucose level measured by the measuring working electrode 14 and the measuring counter electrode 16 is displayed on the display means. Thereby, the measurer can read the blood glucose level with the recognition that the measured value is accurate.

一方、供給口20に点着した血液の量が血糖値を正確に測定するには不十分な量である場合には、予め定めた一定時間内に反応部18の中の供給口20と反対側端部付近に血液が到達せずに反応しないこと若しくは反応部18全体に渡って十分に反応しないことにより、又は検出用作用電極22及び検出用対向電極24間に電子の授受が生じないことにより、検出用作用電極22及び検出用対向電極24間に、電流が生じない、又は僅かな電流のみ生じる。制御手段36は、予め定めた一定時間経過後にこの電流値が一定値未満であることを認識した場合には、血液の量が血糖値を正確に測定するのに不十分な量であることを、計測表示器30の表示手段のエラー表示等によって測定者に認識させる。この場合、測定者は、バイオセンサ10を計測表示器30から外して取り換え、再度測定を行う。   On the other hand, when the amount of blood spotted on the supply port 20 is insufficient to accurately measure the blood glucose level, it is opposite to the supply port 20 in the reaction unit 18 within a predetermined time period. The blood does not reach the side end portion and does not react, or does not react sufficiently over the entire reaction section 18, or the transfer of electrons between the detection working electrode 22 and the detection counter electrode 24 does not occur. Thus, no current is generated or only a small current is generated between the detection working electrode 22 and the detection counter electrode 24. If the control means 36 recognizes that the current value is less than a certain value after a predetermined period of time has elapsed, the control means 36 determines that the amount of blood is insufficient to accurately measure the blood sugar level. Then, the measurement person is made to recognize by the error display on the display means of the measurement display 30 or the like. In this case, the measurer removes and replaces the biosensor 10 from the measurement display 30 and performs measurement again.

以上、本発明の一実施形態について説明したが、本発明はその他の態様でも実施できる。例えば、図3に示すように、バイオセンサ10において、反応部18が、測定用作用電極14、測定用対向電極16、検出用作用電極22及び検出用対向電極24にのみ接触し、図1よりも狭い範囲で設けられてもよい。この場合、反応部18が血液と反応して周辺に溶け出すことにより、又は点着検知用作用電極50及び点着検知用対向電極52が導通することにより、血液の点着を検知できる。   As mentioned above, although one Embodiment of this invention was described, this invention can be implemented also in another aspect. For example, as shown in FIG. 3, in the biosensor 10, the reaction unit 18 contacts only the measurement working electrode 14, the measurement counter electrode 16, the detection working electrode 22, and the detection counter electrode 24. May be provided in a narrow range. In this case, the spotting of the blood can be detected by the reaction unit 18 reacting with the blood and melting out to the periphery, or when the spotting detection working electrode 50 and the spotting detection counter electrode 52 are conducted.

また、本発明は、図4に示すバイオセンサ100、図5に示すバイオセンサ110、図6に示すバイオセンサ120であってもよい。これらのバイオセンサ100、110及び120においては、検出用電極102が1個のみ設けられている。この場合、測定用作用電極14及び測定用対向電極16を利用することにより、検出用電極102、測定用作用電極14及び測定用対向電極16によって、血液の量が血糖値を正確に測定するのに十分な量であることを検出できる。   Further, the present invention may be the biosensor 100 shown in FIG. 4, the biosensor 110 shown in FIG. 5, and the biosensor 120 shown in FIG. In these biosensors 100, 110, and 120, only one detection electrode 102 is provided. In this case, by using the measurement working electrode 14 and the measurement counter electrode 16, the amount of blood accurately measures the blood glucose level by the detection electrode 102, the measurement working electrode 14 and the measurement counter electrode 16. It can be detected that the amount is sufficient.

また、本発明は図示した実施形態には限定されない。例えば、反応部18は、測定用作用電極14及び測定用対向電極16にのみ接触し、図3よりも更に狭い範囲で設けられてもよい。この場合、反応部18が血液と反応して周辺に溶け出すことにより、又は点着検知用作用電極50及び点着検知用対向電極52が導通することにより、血液の点着を検知できる。その他、本発明の技術的範囲には、その趣旨を逸脱しない範囲で当業者の知識に基づき種々なる改良、修正、変形を加えた態様も含まれる。また、同一の作用又は効果が生じる範囲内で、いずれかの発明特定事項を他の技術に置換した形態で実施しても良い。   Further, the present invention is not limited to the illustrated embodiment. For example, the reaction unit 18 may contact only the measurement working electrode 14 and the measurement counter electrode 16 and may be provided in a narrower range than FIG. In this case, the spotting of the blood can be detected by the reaction unit 18 reacting with the blood and melting out to the periphery, or when the spotting detection working electrode 50 and the spotting detection counter electrode 52 are conducted. In addition, the technical scope of the present invention includes embodiments in which various improvements, modifications, and variations are added based on the knowledge of those skilled in the art without departing from the spirit of the present invention. Moreover, you may implement with the form which substituted any invention specific matter to the other technique within the range which the same effect | action or effect produces.

本発明のバイオセンサによれば、採取した血液等がバイオセンサに点着されたか否かを容易に確認できるとともに、反応部まで導入された血液等の量が正確な測定に必要な量であるか否かを正確に検知することができる。このため、バイオセンサによる正確な測定のために広く利用できる。   According to the biosensor of the present invention, it is possible to easily confirm whether or not the collected blood is spotted on the biosensor, and the amount of blood or the like introduced to the reaction part is an amount necessary for accurate measurement. Whether or not can be accurately detected. For this reason, it can be widely used for accurate measurement by a biosensor.

本発明のバイオセンサの正面図である。It is a front view of the biosensor of the present invention. 図1のバイオセンサに使用する計測表示器の回路図である。It is a circuit diagram of the measurement indicator used for the biosensor of FIG. 本発明のバイオセンサの他の実施形態を示す正面図である。It is a front view which shows other embodiment of the biosensor of this invention. 本発明のバイオセンサの更に他の実施形態を示す正面図である。It is a front view which shows other embodiment of the biosensor of this invention. 本発明のバイオセンサの更に他の実施形態を示す正面図である。It is a front view which shows other embodiment of the biosensor of this invention. 本発明のバイオセンサの更に他の実施形態を示す正面図である。It is a front view which shows other embodiment of the biosensor of this invention.

符号の説明Explanation of symbols

10、100、110、120:バイオセンサ
12:基板
14:測定用作用電極
16:測定用対向電極
18:反応部
20:供給口
22:検出用作用電極
24:検出用対向電極
26:スペーサ
28:カバー
30:計測表示器
50:点着検知用作用電極
52:点着検知用対向電極
10, 100, 110, 120: biosensor 12: substrate 14: measuring working electrode 16: measuring counter electrode 18: reaction unit 20: supply port 22: detecting working electrode 24: detecting counter electrode 26: spacer 28: Cover 30: Measurement display device 50: Working electrode for spotting detection 52: Counter electrode for spotting detection

Claims (4)

絶縁体から成る基板と、該基板上に設けられた測定用作用電極と、該基板上に該測定用作用電極と一定間隔を空けて設けられた測定用対向電極と、該測定用作用電極及び該測定用対向電極上に設けられた反応部と、検体を該反応部まで導入する供給口と、を備え、
前記反応部が前記供給口から導入された検体中の特定成分と反応し、該特定成分を定量分析するバイオセンサにおいて、
前記測定用作用電極及び前記測定用対向電極に対して前記供給口と反対側において、前記基板上に、前記導入された検体を検出する検出用電極を備え、
前記測定用作用電極及び前記測定用対向電極に対して前記供給口側において、前記基板上に設けられた点着検知用作用電極と、該基板上に該点着検知用作用電極と一定間隔を空けて設けられた点着検知用対向電極と、を備え、
前記検出用電極、前記点着検知用作用電極及び前記点着検知用対向電極によって前記検体の導入を検知するバイオセンサ。
A substrate made of an insulator, a measurement working electrode provided on the substrate, a measurement counter electrode provided on the substrate at a predetermined interval from the measurement working electrode, the measurement working electrode, and A reaction part provided on the counter electrode for measurement, and a supply port for introducing a specimen to the reaction part,
In the biosensor that reacts with a specific component in the sample introduced from the supply port by the reaction unit and quantitatively analyzes the specific component,
On the opposite side of the supply port with respect to the measurement working electrode and the measurement counter electrode, the substrate includes a detection electrode for detecting the introduced sample,
On the supply port side with respect to the measurement working electrode and the measurement counter electrode, a spotting detection working electrode provided on the substrate, and a predetermined distance from the spotting detection working electrode on the substrate A counter electrode for spotting detection provided in a space;
A biosensor that detects introduction of the specimen by the detection electrode, the spotting detection working electrode, and the spotting detection counter electrode.
前記反応部が、前記点着検知用作用電極及び点着検知用対向電極に接触する請求項1に記載するバイオセンサ。 The biosensor according to claim 1, wherein the reaction unit is in contact with the working electrode for spotting detection and the counter electrode for spotting detection. 前記反応部が前記供給口から導入された検体に反応した時の前記点着検知用作用電極及び点着検知用対向電極間の電流値を検知して、該検体の導入を検知する請求項1又は請求項2に記載するバイオセンサ。 2. The introduction of the specimen is detected by detecting a current value between the spotting detection working electrode and the spotting detection counter electrode when the reaction section reacts to the specimen introduced from the supply port. Alternatively, the biosensor according to claim 2. 前記検出用電極が、前記基板上に設けられた検出用作用電極と、該基板上に該検出用作用電極と一定間隔を空けて設けられた検出用対向電極と、を含む請求項1〜請求項3のいずれかに記載するバイオセンサ。
The detection electrode includes a detection working electrode provided on the substrate, and a detection counter electrode provided on the substrate at a predetermined interval from the detection working electrode. Item 4. The biosensor according to any one of Items 3.
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Cited By (5)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
JP2010230496A (en) * 2009-03-27 2010-10-14 Gunze Ltd Measuring display device having biosensor attached thereto
JP2010256044A (en) * 2009-04-21 2010-11-11 Gunze Ltd Biosensor and method for producing the same
JP2011075411A (en) * 2009-09-30 2011-04-14 Gunze Ltd Apparatus for measurement of substrate component quantity of specimen, biosensor, and measurement display device
JP2012177554A (en) * 2011-02-25 2012-09-13 Gunze Ltd Measurement display device
JP2012527602A (en) * 2009-05-25 2012-11-08 リードウェイ (エイチケイ) リミテッド Biosensor and method of using the same

Citations (4)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
JPH08320304A (en) * 1995-03-17 1996-12-03 Matsushita Electric Ind Co Ltd Biosensor as well as method and apparatus for determination using it
WO2004011921A1 (en) * 2002-07-25 2004-02-05 Arkray, Inc. Sample analyzing method and sample analyzing device
WO2005008231A1 (en) * 2003-06-20 2005-01-27 Roche Diagnostics Gmbh System and method for analyte measurement of biological fluids using dose sufficiency electrodes
WO2006133878A2 (en) * 2005-06-14 2006-12-21 Roche Diagnostics Gmbh Methods and devices for controlling the impact of short circuit faults on co-planar electrochemical sensors

Patent Citations (4)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
JPH08320304A (en) * 1995-03-17 1996-12-03 Matsushita Electric Ind Co Ltd Biosensor as well as method and apparatus for determination using it
WO2004011921A1 (en) * 2002-07-25 2004-02-05 Arkray, Inc. Sample analyzing method and sample analyzing device
WO2005008231A1 (en) * 2003-06-20 2005-01-27 Roche Diagnostics Gmbh System and method for analyte measurement of biological fluids using dose sufficiency electrodes
WO2006133878A2 (en) * 2005-06-14 2006-12-21 Roche Diagnostics Gmbh Methods and devices for controlling the impact of short circuit faults on co-planar electrochemical sensors

Cited By (5)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
JP2010230496A (en) * 2009-03-27 2010-10-14 Gunze Ltd Measuring display device having biosensor attached thereto
JP2010256044A (en) * 2009-04-21 2010-11-11 Gunze Ltd Biosensor and method for producing the same
JP2012527602A (en) * 2009-05-25 2012-11-08 リードウェイ (エイチケイ) リミテッド Biosensor and method of using the same
JP2011075411A (en) * 2009-09-30 2011-04-14 Gunze Ltd Apparatus for measurement of substrate component quantity of specimen, biosensor, and measurement display device
JP2012177554A (en) * 2011-02-25 2012-09-13 Gunze Ltd Measurement display device

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