WO2012023234A1 - Système de biocapteur - Google Patents

Système de biocapteur Download PDF

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Publication number
WO2012023234A1
WO2012023234A1 PCT/JP2011/004050 JP2011004050W WO2012023234A1 WO 2012023234 A1 WO2012023234 A1 WO 2012023234A1 JP 2011004050 W JP2011004050 W JP 2011004050W WO 2012023234 A1 WO2012023234 A1 WO 2012023234A1
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WO
WIPO (PCT)
Prior art keywords
biosensor
analyzer
sensor pack
predetermined position
lever
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Application number
PCT/JP2011/004050
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English (en)
Japanese (ja)
Inventor
勝重 小谷
Original Assignee
株式会社村田製作所
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Application filed by 株式会社村田製作所 filed Critical 株式会社村田製作所
Priority to CN201190000641.7U priority Critical patent/CN203053913U/zh
Priority to JP2012529476A priority patent/JP5382228B2/ja
Publication of WO2012023234A1 publication Critical patent/WO2012023234A1/fr

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    • G—PHYSICS
    • G01—MEASURING; TESTING
    • G01N—INVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
    • G01N33/00—Investigating or analysing materials by specific methods not covered by groups G01N1/00 - G01N31/00
    • G01N33/48—Biological material, e.g. blood, urine; Haemocytometers
    • G01N33/483—Physical analysis of biological material
    • G01N33/487—Physical analysis of biological material of liquid biological material
    • G01N33/4875—Details of handling test elements, e.g. dispensing or storage, not specific to a particular test method
    • G01N33/48757—Test elements dispensed from a stack

Definitions

  • the present invention relates to a biosensor system for quantifying a measurement target substance contained in a specimen supplied to a biosensor installed at a predetermined position of an analyzer.
  • a biosensor system 500 including a biosensor 501 and an analysis device 502 that detachably mounts the biosensor 501 is known (for example, see Patent Document 1).
  • the measurement target substance contained in the sample supplied to the sample supply port 503 located at the tip of the biosensor 501 is quantified by the analyzer 502.
  • the analyzer 502 includes a support unit 504 on which the biosensor 501 is detachably mounted, a display unit 505 that displays a quantitative result of the measurement target substance contained in the sample supplied to the sample supply port 503 of the biosensor 501, and the like. Is provided.
  • a biosensor 501 having an electrode system including a working electrode and a counter electrode and a reaction layer including an enzyme that reacts with the measurement target substance. Is mounted on the support portion 504 of the analyzer 502 by the user. Then, the reducing substance generated by the reaction between the measurement target substance contained in the specimen supplied to the specimen supply port 503 of the biosensor 501 and the enzyme contained in the reaction layer is used as a counter electrode and a working electrode of the biosensor 501.
  • the measurement target substance is quantified by the analyzer 502 by measuring an oxidation current obtained by applying a voltage between and oxidizing.
  • the biosensor 501 is a sensor for quantifying a measurement target substance such as glucose contained in a specimen, and includes an electrode layer formed by providing an electrode on an insulating substrate made of polyethylene terephthalate, and a cover. And a spacer layer disposed between the electrode layer and the cover layer.
  • the spacer layer is provided with a slit for forming a cavity to which the specimen is supplied, and the electrode layer and the cover layer are bonded to the electrode layer by laminating the cover layer via the spacer layer.
  • the slit portion of the spacer layer form a cavity for supplying the specimen, and the specimen is supplied to the cavity from the specimen supply port 503 formed at the tip of the biosensor 501.
  • the cover layer is formed with an air hole 506 that communicates with the end portion of the formed cavity.
  • the electrode layer is provided with a working electrode and a counter electrode, and an electrode system is formed in the electrode layer by providing an electrode pattern electrically connected to each of these electrodes.
  • a reaction layer is provided on the working electrode and the counter electrode, and the working electrode and the counter electrode are provided on the electrode layer so as to be exposed to cavities formed in the biosensor 501, respectively. Therefore, when a liquid specimen is supplied to the cavity from the specimen supply port 503, each electrode and reaction layer exposed to the cavity come into contact with the specimen and the reaction layer dissolves in the specimen.
  • the reaction layer provided on the working electrode and the counter electrode contains an enzyme that reacts with the measurement target substance contained in the specimen and a mediator (electron acceptor). Then, the oxide ions resulting from the dissolution of the mediator in the specimen are reduced to the reduced form by the electrons released when the enzyme and the substance to be measured undergo a redox reaction. Therefore, when a sample containing the measurement target substance is supplied from the sample supply port to the cavity formed in the biosensor 501, the mediator is reduced by the electrons released by the oxidation of the measurement target substance. A reduced form of the mediator is generated in an amount corresponding to the concentration of the substance to be measured that is contained and oxidized by the enzyme reaction.
  • a mediator electron acceptor
  • the oxidation current obtained by oxidizing the reduced form of the mediator generated as a result of the enzyme reaction on the working electrode has a magnitude depending on the glucose concentration in the sample.
  • the glucose contained in the specimen can be quantified by measuring.
  • FIG. 12 shows an example of a conventional biosensor system.
  • the biosensor 501 since the biosensor 501 is usually disposable, it is desired to reduce the manufacturing cost of the biosensor 501. In order to reduce the manufacturing cost of the biosensor 501, it is conceivable to reduce the size of the biosensor 501 in order to suppress material costs. However, in this case, the manufacturing cost of the biosensor 501 can be reduced. On the other hand, as the biosensor 501 is downsized, the handling of the biosensor 501 by the user is deteriorated, and thus the biosensor 501 is downsized. It was an obstacle.
  • the present invention has been made in view of the above problems, and an object of the present invention is to provide a biosensor system capable of reducing the size of the biosensor without impairing the handleability.
  • the inventor of the present application has made a biomedical analysis immediately before quantifying the measurement target substance in order to prevent the enzyme contained in the reaction layer provided in the biosensor from deteriorating due to changes in humidity or temperature.
  • the present invention has been completed by paying attention to the fact that the sensor must be stored in a special container together with the hygroscopic agent or the biosensor must be individually packaged together with the hygroscopic agent.
  • the biosensor system of the present invention includes an electrode system including a working electrode and a counter electrode, a biosensor formed by providing a reaction layer including an enzyme that reacts with a measurement target substance on an insulating substrate, and a predetermined position.
  • An analyzer that quantifies the measurement target substance contained in the specimen supplied to the biosensor, a case body that is formed so as to be grippable by a moisture-impermeable material and has an opening, and a moisture-impermeable material.
  • a sensor pack that closes the opening and is attached to the case body, and stores the biosensor and the hygroscopic agent in a sealed state in a space formed by the case body and the coating film
  • An installation mechanism for taking out the biosensor from the sensor pack attached to the attachment location of the analyzer and installing it at the predetermined position of the analyzer, and the installation machine Holding means for holding the biosensor installed at the predetermined position, and the installation mechanism is provided such that a tip thereof breaks the coating film and can be engaged with the biosensor inside the sensor pack.
  • a moving means for moving the biosensor to the predetermined position together with the cutting means engaged with the biosensor (claim 1).
  • a positioning engagement portion is provided at the mounting location of the analyzer, and an engaged portion that is engaged with the engagement portion when mounted at the mounting location is provided in the sensor pack. (Claim 2).
  • the case body may include a first cavity in which the biosensor is accommodated, and a second cavity that is continuously formed in the first cavity and in which the hygroscopic agent is accommodated. (Claim 3).
  • an electrode that is electrically connected to the electrode system of the biosensor moved by the moving means is arranged at the predetermined position of the analyzer (claim 4).
  • the analyzer has a main body part in which the mounting part is formed in a concave shape, and a lid part that closes the concave mounting part so as to be openable and closable, and the biosensor is connected to the predetermined part in the lid part.
  • a lever as the moving means for moving to a position is slidably provided, and a cutting blade as the cutting means cuts the coating film in conjunction with the movement of the lever to the predetermined position.
  • the lid is further provided with a pressing body as the holding means for holding the biosensor installed at the predetermined position by being slid between the body and the main body. (Claim 6).
  • a case body that is formed so as to be grippable by a non-moisture permeable material and has an opening, and a coating film that is formed of a non-moisture permeable material and closes the opening and is attached to the case body
  • the sensor pack in which the biosensor and the hygroscopic agent are stored in a sealed state in the space formed by the above is mounted at the mounting position of the analyzer.
  • a cutting means provided at its tip to be able to engage the biosensor inside the sensor pack by breaking the coating film of the sensor pack, and a predetermined position of the analyzer together with the cutting means engaged with the biosensor.
  • the biosensor is taken out from the sensor pack attached at the mounting location of the analyzer by the installation mechanism having the moving means to move to the analyzer and installed at a predetermined position of the analyzer, and is installed at the predetermined position of the analyzer by the installation mechanism.
  • the biosensor is held by holding means.
  • the user grasps and analyzes the case body of the sensor pack formed so as to be graspable when quantifying the measurement target substance contained in the specimen. Since it is only necessary to attach the device to the attachment location of the device, the biosensor can be miniaturized without impairing the handleability of the biosensor by the user.
  • the miniaturized biosensor can be easily used as a sensor pack for storing the biosensor properly.
  • a function for handling can be added. Therefore, the user can hold the case body and attach the biosensor together with the sensor pack to the attachment location of the analyzer. If the sensor pack is attached to the attachment location of the analyzer, the installation mechanism causes the biosensor inside the sensor pack to be attached. Since it is taken out and installed at a predetermined position of the analyzer, it is not necessary to prepare a special handling tool or the like for handling a miniaturized biosensor, and the manufacturing cost is not increased.
  • a positioning engagement portion is provided at the mounting position of the analyzer, and the sensor pack is engaged with the positioning engagement portion when mounted at the mounting position. Since the joint portion is provided, the sensor pack can be accurately positioned at the mounting position of the analyzer, and the sensor pack can be prevented from moving when the biosensor inside the sensor pack is taken out by the installation mechanism.
  • the biosensor since the biosensor is housed in the first cavity of the case body, the hygroscopic agent is housed in the second cavity continuously formed in the first cavity, Therefore, it is possible to prevent the biosensor and the hygroscopic agent from contacting each other.
  • the electrode electrically connected to the electrode system of the biosensor moved by the moving means is arranged at a predetermined position of the analyzer, the biosensor is analyzed by the installation mechanism. This is practical because the electrode system of the biosensor and the analysis device are electrically connected when installed at a predetermined position of the device.
  • the sliding portion slides on the lid.
  • a cutting blade coupled to a freely provided lever breaks the coating film of the sensor pack and engages the biosensor so as to be interlocked with the movement of the lever, and the cutting blade attaches the biosensor to a predetermined position of the analyzer.
  • the biosensor engaged with the cutting blade coupled to the lever can be simply moved by sliding the lever.
  • the sensor pack can be easily moved to a predetermined position of the analyzer while cutting the coating film.
  • the biosensor installed at a predetermined position of the analyzer by sliding the lever is narrowed between the main body by the pressing body provided on the lid of the analyzer. It can be held securely.
  • FIG. 2 is a cut side view of the biosensor system of FIG. 1. It is a cutting
  • FIG. 1 It is a perspective view of a biosensor system showing a state where a biosensor is installed at a predetermined position of an analyzer. It is a top view of a sensor pack. It is a principal part enlarged view of the analyzer of the state of FIG. It is a figure which shows the other example of an analyzer. It is a figure which shows the other example of an analyzer. It is a figure which shows an example of the conventional biosensor system.
  • FIG. 1 is a perspective view showing an embodiment of a biosensor system 1 of the present invention.
  • FIG. 2 is a cut side view of the biosensor system 1 of FIG.
  • FIG. 3 is a cut-away side view showing a state where the sensor pack is mounted on the main body of the analyzer.
  • FIG. 4 is a cut-away side view showing a state in which a mounting portion formed in a concave shape on the main body of the analyzer is closed by a lid.
  • FIG. 5 is a cut-away side view showing a state in which a lever provided on the lid of the analyzer slides.
  • FIG. 6 is a cut-away side view showing a state in which the biosensor is installed at a predetermined position of the analyzer.
  • FIG. 1 is a perspective view showing an embodiment of a biosensor system 1 of the present invention.
  • FIG. 2 is a cut side view of the biosensor system 1 of FIG.
  • FIG. 3 is a cut-away side view showing a state where the sensor pack
  • FIG. 7 is a perspective view of the biosensor system 1 showing a state in which the biosensor is installed at a predetermined position of the analyzer.
  • FIG. 8 is a plan view of the sensor pack 10.
  • FIG. 9 is an enlarged view of a main part of the analyzer in the state of FIG. 6, and is a partially cut plan view of the front side of the lid 102.
  • the biosensor system 1 includes an electrode system including a working electrode and a counter electrode, and a biosensor 2 having a reaction layer (not shown) including an enzyme that specifically reacts with a measurement target substance.
  • the sensor pack 10 that houses the biosensor 2 in a sealed state and the analyzer 100 that quantifies the measurement target substance contained in the specimen supplied to the biosensor 2 installed at a predetermined position. That is, the biosensor system 1 includes a measurement target substance such as glucose contained in a specimen such as blood supplied to a cavity provided on the distal end side of the biosensor 2 installed at a predetermined position of the analyzer 100, and a biosensor. 2 by measuring the oxidation current obtained by oxidizing the reducing substance produced by the reaction with the reaction layer provided in 2 by applying a voltage between the working electrode and the counter electrode of the biosensor 2. Quantify the measurement target substance contained in the sample.
  • the biosensor 2 is formed of an insulating material such as ceramic, glass, plastic, paper, biodegradable material, polyethylene terephthalate, and the like, and an electrode layer provided with a working electrode and a counter electrode, and a cavity for forming a cavity.
  • the spacer layer in which the slit is formed and the cover layer in which the air hole is formed are formed by laminating and bonding them with the front end side aligned.
  • the electrode layer is formed of a substrate made of polyethylene terephthalate, and is formed of a noble metal such as platinum, gold, palladium, or a conductive material such as carbon formed on the substrate by screen printing or sputtering deposition.
  • a noble metal such as platinum, gold, palladium, or a conductive material such as carbon formed on the substrate by screen printing or sputtering deposition.
  • the spacer layer is formed of a substrate made of polyethylene terephthalate, and a slit for forming a cavity is formed at substantially the center of the front end edge of the substrate, and the electrode layer and the front end are aligned and laminated. Glued.
  • the reaction layer consists of a thickener such as carboxymethylcellulose and gelatin, an enzyme, a mediator, and an amino acid before the cover layer is laminated on the working electrode and the counter electrode exposed in the cavity formed by laminating the spacer layer on the electrode layer. And a reagent containing an additive such as an organic acid is dropped. Further, in order to smoothly supply a specimen such as blood to the cavity, a hydrophilizing agent such as a surfactant or phospholipid is applied to the inner wall of the cavity.
  • Enzymes include glucose oxidase, lactate oxidase, cholesterol oxidase, alcohol oxidase, sarcosine oxidase, fructosylamine oxidase, pyruvate oxidase, glucose dehydrogenase, lactate dehydrogenase, alcohol dehydrogenase, hydroxybutyrate dehydrogenase, cholesterol esterase, creatininase, creatinase DNA polymerase or the like can be used, and various sensors can be formed by selecting these enzymes according to the substance to be measured.
  • glucose oxidase or glucose dehydrogenase can be used to form a glucose sensor that detects glucose in a specimen
  • alcohol oxidase or alcohol dehydrogenase can be used to form an alcohol sensor that detects ethanol in a specimen
  • lactate oxidase can be used to form a specimen.
  • a lactic acid sensor for detecting lactic acid therein can be formed, and a total cholesterol sensor can be formed by using a mixture of cholesterol esterase and cholesterol oxidase.
  • potassium ferricyanide As the mediator, potassium ferricyanide, ferrocene, ferrocene derivatives, benzoquinone, quinone derivatives, osmium complexes, ruthenium complexes and the like can be used.
  • the cover layer is formed of a substrate made of polyethylene terephthalate, and air holes communicating with the cavities when formed on the spacer layer are formed in the substrate. Then, after the cover layer is formed on the working electrode and the counter electrode where the reaction layer is exposed to the cavity, the cover layer is laminated and bonded to the spacer layer, so that a sample supply port for supplying the sample to the cavity is formed at the tip. A biosensor 2 is formed.
  • the biosensor system 1 is formed for the purpose of quantifying glucose in blood, and includes glucose oxidase as an enzyme that specifically reacts with glucose as a measurement target substance.
  • the sensor pack 10 includes a case body 11 that is formed so as to be grippable by a non-moisture permeable material and has an opening, and a coating that is formed of a non-moisture permeable material and closes the opening of the case body 11 and is attached to the case body 11. And a membrane 12. As shown in FIG. 2, the biosensor 2 and the hygroscopic agent 3 are housed in a sealed state in a space formed by the case body 11 and the coating film 12.
  • the sensor pack 10 is provided with an engaged portion 13 that engages with a positioning engaging portion 104 provided at a mounting location 103 of the analyzer 100 described later.
  • the case body 11 is provided with a first cavity 14 in which the biosensor 2 is accommodated, and a second cavity 15 that is continuously formed in the first cavity 14 and accommodates a hygroscopic agent. .
  • the case body 11 is formed of a laminated member of polyethylene, aluminum foil, and polyethylene
  • the coating film 12 is formed of a laminated film of aluminum foil and polyethylene
  • the coating film 12 is The opening of the case body 11 is closed and fused to the case body.
  • the hygroscopic agent 3 is formed of a hygroscopic material such as zeolite or silica gel.
  • the moisture permeable material such as the metal foil or DLC (Diamond-like Carbon) laminated as the moisture permeable material is ensured to be moisture permeable. Any material can be used as long as it can be used.
  • the analyzer 100 includes a main body 101 in which a concave mounting location 103 to which the sensor pack 10 is mounted is formed, and a lid portion 102 that closes the concave mounting location 103 so as to be freely opened and closed.
  • the lid portion 102 is detachably formed on the main body portion 101.
  • a positioning engagement portion 104 is provided at the concave mounting portion 103 formed in the main body 101, and the sensor pack 10 is attached to the concave mounting portion 103 of the main body 101 as shown in FIG.
  • the engaging portion 104 (columnar protrusion) of the mounting portion 103 and the engaged portion 13 (round hole) of the sensor pack 10 are engaged.
  • the sensor pack 10 is attached to the attachment location 103 by inserting the columnar protrusion as the engagement portion 104 of the attachment location 103 into the round hole as the engaged portion 13 of the sensor pack 10.
  • the combination of the engaging portion 104 and the engaged portion 13 is not limited to the combination of the columnar protrusion and the round hole, and the combination of the notch and the protrusion that engages with this.
  • the engaging portion 104 and the engaged portion 13 may have any shape as long as the sensor pack 10 can be accurately positioned at the mounting location 103 such as alignment.
  • the lid 102 is provided with an installation mechanism for taking out the biosensor 2 from the sensor pack 10 attached to the attachment location 103 of the main body 101 and installing it at a predetermined position 105 of the analyzer 100. That is, a concave portion 106 is formed on the upper surface of the lid portion 102, and a slide hole 107 extending in the longitudinal direction of the lid portion 102 is formed in the concave portion 106, and the slide hole 107 is attached to the attachment portion 103 of the main body portion 101.
  • a lever 108 as a moving means for moving the biosensor 2 in the sensor pack 10 to a predetermined position 105 is provided slidably along the slide hole 107.
  • the lever 108 has a cutting blade 109 as a cutting means provided so that the tip thereof breaks the coating film 12 of the sensor pack 10 and can be engaged with the biosensor 2 inside the sensor pack 10.
  • the coupling film 12 of the sensor pack 10 is coupled so as to be cut in conjunction with the movement to the position 105.
  • cam holes 110 are formed on both inner sides of the slide hole 107 provided in the lid portion 102, and the cam hole 110 is a lower horizontal hole formed from the rear part to the center part of the slide hole 107.
  • the lever 108 is provided with a driven pin 111 fixed to the lever 108 inserted through the cam hole 110.
  • the lid 102 with the lever 108 moved to the rearmost side of the lid 102 in the state where the sensor pack 10 is attached to the mounting portion 103 of the main body 101 is attached to the main body 101.
  • the cutting blade 109 breaks the coating film 12 of the sensor pack 10 and engages the biosensor 2 so as to be interlocked with the movement of the lever 108.
  • FIG. 5 when the lever 108 is slid along the slide hole 107 toward the predetermined position 105 on the front side of the lid portion 102, the covering film 12 of the sensor pack 10 is moved by the cutting blade 109. While being cut, the biosensor 2 moves to the predetermined position 105 together with the cutting blade 109 engaged with the biosensor 2.
  • the concave mounting portion 103 of the main body 101 is closed by the lid 102.
  • the cutting blade 109 breaks the portion surrounded by the dotted line A of the coating film 12 of the sensor pack 10 and between the biosensor 2 and the hygroscopic agent 3. Since the cutting blade 109 is reliably engaged with the rear side of the biosensor 2, there is no possibility that the main body of the biosensor 2 is damaged by the cutting blade 109.
  • the sensor pack 10 is positioned at the mounting location 103 of the main body 101 by engaging the engaged portion 13 with the engaging portion 104, so that the coating film 12 is removed from the cutting blade 109 as the lever 108 is operated. There is no possibility that the sensor pack 10 will be displaced when it is cut.
  • the case body 11 has a side cross section, and the biosensor 2 is mounted when the sensor pack 10 is mounted on the mounting location 103. It is formed in a ship shape in which the side facing the direction of the predetermined position 105 to be installed is the bow. Therefore, when the biosensor 2 moves in the direction of the predetermined position 105 on the front side by the cutting blade 109, the biosensor 2 moves upward toward the predetermined position 105 along the shape of the bow side of the case body 11.
  • the cutting blade 109 may come into contact with the case body 11 and the sliding movement of the lever 108 may be hindered. There is no. Further, since the cutting blade 109 pushes the biosensor 2 forward toward the predetermined position 105 while moving upward, the biosensor 2 is moved to the case by the upward movement of the cutting blade 109 engaged with the biosensor 2. It moves reliably toward the upper predetermined position 105 along the shape of the bow side of the body 11.
  • a pressing body 113 is disposed on the front side of the lid 102, that is, at a position corresponding to the predetermined position 105 in a state of being lifted upward by a biasing body 112 such as a spring. ing.
  • the pressing body 113 has two rod-like operating pieces on both sides of a flat pressing portion and is formed in a substantially U-shape when viewed from above, and is slid by the two operating pieces. It arrange
  • an inclined surface is formed at the tip of the operating piece of the pressing body 113 so as to follow the oblique hole of the slide hole 110.
  • an electrode that is electrically connected to the electrode system of the biosensor 2 installed by sliding the lever 108 forward is disposed at a predetermined position 105 of the main body 101.
  • the biosensor 2 installed and held at the predetermined position 105 is electrically connected to various circuits (not shown) provided in the analyzer 100.
  • the analysis apparatus 100 is automatically turned on when it is detected that the biosensor 2 is installed at the predetermined position 105, and when a sample such as blood is supplied to the biosensor 2, Measurement of a measurement target substance such as glucose is started.
  • a measurement target substance such as glucose
  • the measurement result is displayed on the display unit 114 formed by a display means such as an LCD, and an alarm for signaling the end of the measurement is output from the speaker.
  • the result is stored in a storage unit formed by a storage medium such as a memory.
  • the analysis apparatus 100 also includes an operation unit 115 formed by an operation switch or the like, and various initial settings are executed by operating the operation unit 115 or past measurement results stored in the storage unit. Etc. are displayed on the display unit 114.
  • the analysis apparatus 100 includes a serial interface (I / F), and can transmit and receive data such as measurement results to and from an external personal computer connected via the I / F.
  • a serial interface I / F
  • a program that realizes various functions by being executed by the CPU is stored.
  • the analyzer 100 includes a voltage output unit, a current-voltage conversion unit, and an A / D conversion unit.
  • the voltage output unit has a digital-analog conversion function (D / A conversion function), and outputs a constant reference potential to the counter electrode of the biosensor 2 attached to the analyzer 100 based on a control command from the CPU.
  • a predetermined potential based on the reference potential applied to the counter electrode is output to the working electrode.
  • the current-voltage conversion unit has a general current-voltage conversion circuit formed by an operational amplifier and a resistance element, and a predetermined potential is applied to the working electrode of the biosensor 2 by the voltage output unit, so that the working electrode and the counter electrode are The current flowing between them is converted into a voltage signal so that it can be taken into the CPU.
  • the A / D conversion unit converts the voltage signal converted by the current-voltage conversion unit into a digital signal.
  • the digital signal converted by the A / D conversion unit is taken into the CPU, and a predetermined calculation is performed in the CPU, whereby the voltage signal is converted into a current signal.
  • the CPU has the following functions by executing various programs stored in the storage unit for quantifying the measurement target substance contained in the specimen.
  • the detection unit monitors the value of the current flowing between the working electrode and the counter electrode input to the CPU via the A / D conversion unit, thereby causing resistance between the working electrode and the counter electrode to be short-circuited by the specimen made of liquid. By detecting a change in the value, it is detected that the specimen is supplied to the cavity provided in the biosensor 2. Based on a clock signal output from a clock circuit (not shown), the time measuring unit, for example, an elapsed time after the detection unit detects the supply of the specimen to the cavity, or a predetermined output to the working electrode by the voltage output unit. Time the potential application time.
  • the measuring unit measures the current flowing between the working electrode and the counter electrode when a predetermined potential based on the counter electrode is applied to the working electrode by the voltage output unit.
  • the quantitative unit quantifies the measurement target substance based on the current measured by the measurement unit in the quantitative process. Specifically, a conversion formula for converting the concentration from the current value is obtained by measuring in advance the relationship between the current value flowing between the working electrode and the counter electrode and the concentration of the measurement target substance contained in the specimen. Derived and stored in the storage unit in advance. Then, the measurement target substance is quantified based on the conversion formula stored in the storage unit and the actually measured current value.
  • the notification unit performs notification by displaying the result of quantification by the quantification unit on the display unit 114 or by outputting an alarm indicating that the measurement is completed from the speaker.
  • the sensor pack 10 in which one disposable biosensor 2 is accommodated is attached to the attachment location 103 of the main body 101 of the analyzer 100 by the user. Then, as shown in FIG. 4, the lid 102 is attached to the main body 101 in a state where the sensor pack 10 is attached to the attachment location 103 of the main body 101.
  • the biosensor 2 is installed at the predetermined position 105 of the analyzer 100 by sliding the lever 108 toward the predetermined position 105 ahead (see FIG. 7). ).
  • the power is automatically turned on, and when a sample such as blood is supplied to the biosensor 2, the glucose or the like in the sample is detected. Measurement of the target substance is started.
  • the measurement result is displayed on the display unit 114 and an alarm for signaling the end of the measurement is output from the speaker.
  • the cover part 102 should just be removed from the main-body part 101, and the used biosensor 2 and the sensor pack 10 should be removed and discarded.
  • the case body 11 formed so as to be grippable by a non-moisture permeable material and having an opening, and the opening formed by the non-moisture permeable material is closed and attached to the case body 11.
  • the sensor pack 10 in which the biosensor 2 and the hygroscopic agent 3 are stored in a sealed state in a space formed by the coating film 12 to be mounted is mounted on the mounting portion 103 of the analyzer.
  • the cutting edge 109 provided so that the tip breaks the coating film 12 of the sensor pack 10 and can be engaged with the biosensor 2 inside the sensor pack 10, and the cutting with the biosensor 2 engaged with the biosensor 2
  • the biosensor 2 is taken out from the sensor pack 10 mounted at the mounting location 103 of the analyzer 100 by the installation mechanism having the lever 109 that moves to the predetermined position 105 of the analyzer 100 together with the blade 109, and the predetermined position of the analyzer 100
  • the biosensor 2 installed at the predetermined position 105 of the analyzer 100 by the sliding movement of the lever 108 and the cutting blade 109 is installed on the pressure body 113 provided on the lid portion 102 of the analyzer 100 and the main body. It is pinched between the part 101 and hold
  • the measurement target substance contained in the specimen is quantified by the analyzer 100.
  • the user grasps the case body 11 of the sensor pack 10 formed so as to be graspable when the measurement target substance contained in the specimen is quantified.
  • the biosensor 2 can be reduced in size without impairing the handleability of the biosensor 2 by the user.
  • the biosensor 2 is stored together with the hygroscopic agent 3 until just before the measurement target substance is quantified.
  • the sensor pack 10 for properly storing the biosensor 2 can be formed.
  • a function for easily handling the miniaturized biosensor 2 is provided. Therefore, the user can hold the case body 11 and attach the biosensor 2 together with the sensor pack 10 to the attachment location 103 of the analyzer 100.
  • a cutting blade 109 coupled to a freely provided lever 108 breaks the coating film 12 of the sensor pack 10 and engages the biosensor 2 so as to be interlocked with the movement of the lever 108.
  • the lever 108 is simply slid. The biosensor 2 engaged with the cutting blade 109 coupled to the lever 108 can be easily analyzed while cutting the coating film 12 of the sensor pack 10. 00 can be moved to a predetermined position 105.
  • a positioning engagement portion 104 is provided at the mounting location 103 of the analyzer 100, and the sensor pack 10 is engaged to be engaged with the positioning engagement portion 104 when being mounted at the mounting location 103. Since the portion 13 is provided, the sensor pack 10 can be accurately positioned at the mounting location 103 of the analyzer 100, and the biosensor 2 inside the sensor pack 10 is taken out by sliding the lever 108 and the cutting blade 109. Occasional displacement of the sensor pack 10 can be prevented.
  • the biosensor 2 is stored in the first cavity 14 of the case body 11, and the hygroscopic agent is stored in the second cavity 15 continuously formed in the first cavity 14, It can prevent that the biosensor 2 and the hygroscopic agent 3 contact.
  • the biosensor 2 since the electrode electrically connected to the electrode system of the biosensor 2 moved by the lever 108 and the cutting blade 109 is disposed at the predetermined position 105 of the analyzer 100, the biosensor 2 is mounted by the installation mechanism. This is practical because the electrode system of the biosensor 2 and the analyzer 100 are electrically connected when installed at the predetermined position 105 of the analyzer 100.
  • the sensor pack 10 in which one biosensor 2 is stored in a disposable manner for example, a plurality of biosensors 2 are stored in the sensor pack 10, and only one of the biosensors 2 is stored.
  • the mechanism for taking out the biosensor 2 stored in the sensor pack 10 can be simplified.
  • the installation mechanism for taking out the biosensor 2 and the structure of the mounting portion 103 of the analyzer 100 on which the disposable sensor pack 10 is mounted can be simplified, the user can Even without receiving an explanation of handling, the method of using the biosensor system 1 can be easily conceived. Therefore, even if the biosensor system 1 is not used for a long period of time, the user can avoid a situation in which the biosensor system 1 cannot be used by forgetting how to use the biosensor system 1. it can.
  • the present invention is not limited to the above-described embodiment, and various modifications other than those described above can be made without departing from the spirit thereof.
  • the main body 101 of the analyzer 100 can be changed.
  • the lid portion 102 may be connected to the rear side thereof by a hinge structure.
  • the main body 201 and the lid 202 of the analyzer 200 may be slidably connected in the longitudinal direction.
  • the sensor pack 10 can be attached to the attachment location 203 when the lid portion 202 is slid backward with respect to the main body portion 201 and the attachment location 203 is opened. it can.
  • a cutting blade as a cutting means is attached to the front side portion of the lid portion 200 so as to be freely retractable, the lid portion 202 is slid relative to the main body portion 201, and the cutting blade becomes a sensor pack.
  • the cutting blade breaks the coating film 12 of the sensor pack 10 and engages the biosensor 2.
  • FIG. 10 and FIG. 11 are diagrams showing other examples of the analyzer, and show different states.
  • the hygroscopic agent housed in the sensor pack in a sealed state is not limited to the above-described tablet-like one.
  • the hygroscopic material is kneaded into the adhesive that bonds the case body and the coating film. It is good also as a hygroscopic agent. If it does in this way, it can prevent effectively that a water
  • any moisture absorbent may be accommodated in the sensor pack as long as the moisture in the sensor pack can be absorbed.
  • the present invention can be applied to a biosensor system that performs measurement using various biosensors.

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Abstract

L'invention concerne un système de biocapteur permettant d'obtenir un biocapteur compact sans altérer sa capacité de manipulation. Un ensemble capteur (10), contenant un biocapteur (2) à l'état scellé, est saisi et monté dans une position de montage (103) d'un analyseur, moyennant quoi le biocapteur (2) est sorti de l'ensemble capteur (10) et disposé dans une position prédéterminée (105) de l'analyseur (100), et le biocapteur (2) disposé est maintenu de manière fiable en étant pris en sandwich entre un corps de pression (113) et une section de corps (101). En conséquence, même si le biocapteur (2) est réalisé de manière compacte afin de réduire les coûts de fabrication, un utilisateur doit simplement saisir un corps de boîtier (11) de l'ensemble capteur (10) formé de façon à être saisi et monter le corps de boîtier correspondant dans la position de montage (103) de l'analyseur (100), en permettant ainsi d'obtenir un biocapteur (2) compact, sans altérer la capacité de manipulation du biocapteur (2) par l'utilisateur.
PCT/JP2011/004050 2010-08-19 2011-07-15 Système de biocapteur WO2012023234A1 (fr)

Priority Applications (2)

Application Number Priority Date Filing Date Title
CN201190000641.7U CN203053913U (zh) 2010-08-19 2011-07-15 生物传感器系统
JP2012529476A JP5382228B2 (ja) 2010-08-19 2011-07-15 バイオセンサシステム

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JP2010-183776 2010-08-19
JP2010183776 2010-08-19

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WO2012023234A1 true WO2012023234A1 (fr) 2012-02-23

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JP (2) JP5382228B2 (fr)
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WO (1) WO2012023234A1 (fr)

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Publication number Priority date Publication date Assignee Title
WO2020155081A1 (fr) * 2019-02-01 2020-08-06 浙江凯立特医疗器械有限公司 Capteur d'étanchéité et dispositif de détection

Citations (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
JP2001033418A (ja) * 1999-07-26 2001-02-09 Matsushita Electric Ind Co Ltd 測定装置
JP2006170974A (ja) * 2004-12-15 2006-06-29 F Hoffmann-La Roche Ag 分析試験エレメント上での液体試料の分析用分析システム
JP2009150905A (ja) * 2002-05-23 2009-07-09 Arkray Inc 分析用具パック、および分析装置

Patent Citations (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
JP2001033418A (ja) * 1999-07-26 2001-02-09 Matsushita Electric Ind Co Ltd 測定装置
JP2009150905A (ja) * 2002-05-23 2009-07-09 Arkray Inc 分析用具パック、および分析装置
JP2006170974A (ja) * 2004-12-15 2006-06-29 F Hoffmann-La Roche Ag 分析試験エレメント上での液体試料の分析用分析システム

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JP5382228B2 (ja) 2014-01-08
JPWO2012023234A1 (ja) 2013-10-28
JP5429426B2 (ja) 2014-02-26
JP2013224972A (ja) 2013-10-31

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