JPWO2012023234A1 - Biosensor system - Google Patents

Abstract

Provided is a biosensor system capable of reducing the size of a biosensor without impairing handleability. By grasping the sensor pack 10 in which the biosensor 2 is housed in a sealed state and attaching the sensor pack 10 to the attachment portion 103 of the analyzer, the biosensor 2 is taken out from the sensor pack 10 and placed in a predetermined position 105 of the analyzer 100. The installed biosensor 2 is sandwiched between the pressing body 113 and the main body 101 and securely held. Therefore, even if the biosensor 2 is downsized in order to reduce the manufacturing cost, the user only holds the case body 11 of the sensor pack 10 formed so as to be gripped and mounts it on the mounting portion 103 of the analyzer 100. Therefore, the size of the biosensor 2 can be reduced without impairing the handleability of the biosensor 2 by the user.

Description

  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.

  Conventionally, as shown in FIG. 12, a biosensor system 500 including a biosensor 501 and an analyzer 502 on which the biosensor 501 is detachably attached is known (for example, see Patent Document 1). In the biosensor system 500, 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.

  In the biosensor system 500 described above, in order to quantify a measurement target substance contained in a specimen, first, 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.

  Specifically, 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. In addition, 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. And 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.

  Further, 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. In addition, 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.

  In addition, 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.

  In the biosensor 501 formed in this way, 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.

JP 2003-156469 A (paragraphs [0032] to [0052], FIG. 1, etc.)

  By the way, 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.

  In order to achieve the above object, 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 And an installation mechanism for taking out the biosensor from the sensor pack mounted at the mounting location of the analyzer and installing it at the predetermined position of the analyzer, and the installation mechanism 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. And a moving means for moving the biosensor to the predetermined position together with the cutting means engaged with the biosensor (claim 1).

  Further, 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).

  In addition, an electrode that is electrically connected to the electrode system of the biosensor moved by the moving means is disposed at the predetermined position of the analyzer (claim 4).

  Further, 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. When the concave mounting portion of the main body is closed by the lid portion with the sensor pack being mounted at the mounting location, the cutting blade is attached to the sensor pack. The cover film is broken and engaged with the biosensor so as to be interlocked with the movement of the lever (Claim 5).

  In addition, 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).

  According to the invention of claim 1, 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.

  And 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. As described above, when the specimen is supplied to the biosensor installed at the predetermined position of the analyzer by the installation mechanism and held by the holding means, the measurement target substance contained in the specimen is quantified by the analyzer.

  Therefore, even when the biosensor is downsized to reduce the manufacturing cost, 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.

  That is, in order to prevent the enzyme contained in the reaction layer provided in the biosensor from deteriorating due to changes in humidity or temperature, it is necessary to store the biosensor together with a hygroscopic agent until just before quantifying the measurement target substance. However, by forming the case body of the sensor pack that holds the biosensor and the hygroscopic agent together in a sealed state, 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.

  According to the invention of claim 2, 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.

  According to the invention of claim 3, 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.

  According to the invention of claim 4, since 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.

  According to the fifth aspect of the present invention, when the concave mounting portion is closed by the lid portion in a state where the sensor pack is mounted on the mounting portion formed in the concave shape in the main body portion of the analyzer, the slide portion slides on the lid portion. 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. In order to cut the coating film of the sensor pack in conjunction with the sliding movement of the lever for moving to a predetermined position, 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.

  According to the invention of claim 6, 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.

It is a perspective view which shows one Embodiment of the biosensor system of this invention. FIG. 2 is a cut side view of the biosensor system of FIG. 1. It is a cutting | disconnection side view which shows the state with which the sensor pack was mounted | worn with the main-body part of the analyzer. It is a cutting | disconnection side view which shows the state by which the attachment location formed in concave shape in the main-body part of the analyzer was obstruct | occluded with the cover part. It is a cutting | disconnection side view which shows the state which the lever provided in the cover part of the analyzer slides. It is a cutaway side view showing the state where the biosensor is installed at a predetermined position of the analyzer. 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.

  An embodiment of the biosensor system of the present invention will be described with reference to FIGS.

  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. 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.

  As shown in FIGS. 1 and 2, 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.

(Biosensor)
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.

  In this embodiment, the electrode layer is formed of a substrate made of polyethylene terephthalate, and is formed from 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. By patterning the electrode film formed by laser processing or the like, the working electrode and the counter electrode, and when the biosensor is installed at a predetermined position of the analyzer 100, the working electrode and the counter electrode are electrically connected to the analyzer 100. Electrode patterns to be connected to each other.

  In addition, 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.

  For example, 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, and 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.

  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.

  In this embodiment, 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. A reaction layer containing potassium ferricyanide as a mediator that is reduced by electrons generated by the reaction between glucose and glucose oxidase, which is a reducing substance, is provided on the working electrode and the counter electrode that are exposed to the cavity.

(Sensor pack)
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.

  Further, 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. Further, 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. .

  In this embodiment, 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, and 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.

  As described above, as the material of the case body 11 and the coating film 12, non-moisture permeability is ensured, such as a laminate of metal permeable material or DLC (Diamond-like Carbon) which is a moisture permeable material. Any material can be used as long as it can be used.

(Analysis equipment)
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. When the lid portion 102 is attached to the main body portion 101 so that the concave attachment portion 103 is closed by the lid portion 102, the main body portion 101 and The mutual connectors (not shown) of the lid portion 102 are connected, and various circuits provided in the main body portion 101 and various circuits provided in the lid portion 102 are electrically connected.

  In addition, 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. At the time of mounting, 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. In this embodiment, 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. However, 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. Further, 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.

  Further, 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 upper horizontal hole formed in the front portion of the slide hole 107 and the oblique hole communicating the lower and upper horizontal holes. The lever 108 is provided with a driven pin 111 fixed to the lever 108 inserted through the cam hole 110.

  Therefore, as shown in FIG. 4, 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. When attached and the concave mounting portion 103 of the main body 101 is closed, 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. As shown in 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.

  At this time, as shown in FIG. 8, since the biosensor 2 is positioned and accommodated in the first cavity 14 of the case body 11, the concave mounting portion 103 of the main body 101 is closed by the lid 102. When the cutting blade 109 is engaged with the biosensor 2, 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. In addition, 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.

  Moreover, in this embodiment, in order to facilitate the biosensor 2 to be pushed out of the sensor pack 10 by the cutting blade 109, 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. At this time, since the lever 108 and the cutting blade 109 move upward while sliding forward along the cam hole 107, 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.

  As shown in FIG. 2, 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. As shown in FIG. 9, 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 | positions so that the hole 107 may be pinched | interposed from both sides. In addition, 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.

  Therefore, as shown in FIG. 5, when the lever 108 is slid forward to the position where the driven pin 111 contacts the inclined surface of the tip of the operating piece of the pressing body 113, the operating piece of the pressing body 113 by the driven pin 111. Is started, and the pressing body 113 moves downward against the urging force of the urging body 112. As shown in FIGS. 6 and 9, the biosensor 2 installed at the predetermined position 105 of the analyzer 100 after the forward movement of the lever 108 is completed is accompanied by the forward movement of the lever 108. The pressing body 113 that moves downward and the main body 101 are held and held.

  In addition, an electrode (not shown) 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. When quantification of the measurement target substance in the sample is completed, 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. In the storage unit, a conversion formula for quantifying the measurement target substance contained in the specimen based on the past measurement result and the response current measured by applying a predetermined potential to the working electrode of the biosensor 2. A program that realizes various functions by being executed by the CPU is stored.

  Moreover, 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. At the same time, 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 by 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 sample.

  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.

  A measurement part measures the electric current which flows between a working electrode and a counter electrode, when the predetermined electric potential on the basis of a counter electrode is applied to a working electrode by a voltage output part.

  The quantification unit quantifies the measurement target substance based on the current measured by the measurement unit in the quantification step. 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.

(how to use)
Next, an example of how to use the biosensor system 1 will be described.

  First, as shown in FIG. 3, 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.

  Subsequently, as shown in FIGS. 5 and 6, 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). ). When it is detected that the biosensor 2 is installed at the predetermined position 105 of the analyzer 100, 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.

  When the measurement of the measurement target substance in the sample is completed, 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. In addition, if a user confirms the measurement result displayed on the display part 114, 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.

  As described above, according to this embodiment, 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.

  Then, 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 | maintained reliably. As described above, when the specimen is supplied to the biosensor 2 installed at the predetermined position 105 of the analyzer 100 by the installation mechanism, the measurement target substance contained in the specimen is quantified by the analyzer 100.

  Therefore, even when the biosensor 2 is downsized in order to reduce the manufacturing cost, 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. Thus, since it is only necessary to attach the biosensor 2 to the attachment location 103 of the analyzer 100, the biosensor 2 can be reduced in size without impairing the handleability of the biosensor 2 by the user.

  That is, in order to prevent the enzyme contained in the reaction layer provided in the biosensor 2 from deteriorating due to changes in humidity or temperature, the biosensor 2 is stored together with the hygroscopic agent 3 until just before the measurement target substance is quantified. Although it is necessary, by forming the case body 11 of the sensor pack 10 that accommodates the biosensor 2 and the hygroscopic agent 3 together in a sealed state, 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. If the sensor pack 10 is attached to the attachment location 103 of the analyzer 100, the installation mechanism Since the biosensor 2 inside the sensor pack 10 is taken out by the above and installed at the predetermined position 105 of the analyzer 100, there is no need to prepare a special handling tool for handling the miniaturized biosensor 2, and the manufacture. There is no increase in cost.

  Further, when the concave mounting portion 103 is closed by the lid portion 102 in a state where the sensor pack 10 is attached to the mounting portion 103 formed in the concave shape in the main body portion 101 of the analyzer 100, the slide portion slides on the lid portion 102. 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. In order to cut the coating film 12 of the sensor pack 10 in conjunction with the sliding movement of the lever 108 for moving the sensor 2 to the predetermined position 105 of the analyzer 100 to the predetermined position 105, 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. 0 can be moved to a predetermined position 105.

  Further, 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.

  Further, since 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.

  In addition, 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.

  Further, by using 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. Compared to forming a mechanism for taking out, the mechanism for taking out the biosensor 2 stored in the sensor pack 10 can be simplified. As described above, since 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.

  Note that 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. For example, 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.

  Further, as shown in FIGS. 10 and 11, the main body 201 and the lid 202 of the analyzer 200 may be slidably connected in the longitudinal direction. In this way, as shown in FIG. 11, 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. In the analyzing apparatus 200, 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. When the cutting blade emerges downward from the lid portion 202 when facing 10, the cutting blade breaks the coating film 12 of the sensor pack 10 and engages the biosensor 2.

  Further, when the lid 202 is slid, the biosensor 2 in the sensor pack 10 is pushed toward the predetermined position 205, and the sliding movement of the lid 202 with respect to the main body 201 is completed. The biosensor 2 is installed at a predetermined position 205 of the analyzer 200. Similar to the analysis apparatus 100 described above, the lid section 202 of the analysis apparatus 200 is provided with a display unit 214 and an operation unit 215. The other configuration is the same as the configuration of the analysis apparatus 100 described above, and therefore the same and corresponding reference numerals are given and description of the configuration is omitted. FIG. 10 and FIG. 11 are diagrams showing other examples of the analyzer, and show different states.

  In addition, the hygroscopic agent housed in the sensor pack in a sealed state is not limited to the above-described tablet-like one. For example, 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 | moisture content permeates into a sensor pack from the adhesion part of a case body and a coating film. As described above, any moisture absorbent may be accommodated in the sensor pack as long as moisture in the sensor pack can be absorbed.

  The present invention can be applied to a biosensor system that performs measurement using various biosensors.

DESCRIPTION OF SYMBOLS 1 Biosensor system 2 Biosensor 3 Hygroscopic agent 10 Sensor pack 11 Case body 12 Cover film 13 Engagement part 14 1st cavity 15 2nd cavity 100,200 Analyzer 101,201 Main-body part 102,202 Cover part 103, 203 mounting location 104 engaging portion 105 predetermined position 108 lever 109 cutting blade 113 pressing body

Claims (6)

A biosensor formed by providing an insulating substrate with an electrode system including a working electrode and a counter electrode, and a reaction layer including an enzyme that reacts with a measurement target substance;
An analyzer for quantifying the measurement target substance contained in a specimen supplied to the biosensor installed at a predetermined position;
A case body that is formed so as to be grippable by a moisture-impermeable material and has an opening; and a coating film that is formed of a moisture-impermeable material and that covers the opening and is attached to the case body. And a sensor pack for storing the biosensor and the hygroscopic agent in a sealed state in a space formed by 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;
Holding means for holding the biosensor installed at the predetermined position by the installation mechanism;
The installation mechanism is
Cutting means provided with a tip that breaks the coating film to be able to engage with the biosensor inside the sensor pack;
A biosensor system comprising: moving means for moving the biosensor to the predetermined position together with the cutting means engaged with the biosensor. A positioning engagement portion is provided at the mounting location of the analyzer,
The biosensor system according to claim 1, wherein the sensor pack is provided with an engaged portion that engages with the engaging portion when the sensor pack is attached to the attachment location. The case body is
3. The apparatus according to claim 1, comprising: 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. Biosensor system.   The electrode electrically connected to the electrode system of the biosensor moved by the moving means is disposed at the predetermined position of the analyzer. The biosensor system according to 1. The analyzer is
A body portion in which the mounting portion is formed in a concave shape;
And a lid that closes the concave mounting portion so as to be openable and closable,
In the lid,
A lever as the moving means for moving the biosensor to the predetermined position is slidably provided, and a cutting blade as the cutting means is coupled to the lever in conjunction with the movement of the lever to the predetermined position. It is combined to cut the coating film,
In a state where the sensor pack is mounted at the mounting location, when the concave mounting location of the main body is closed by the lid portion, the cutting blade breaks the coating film of the sensor pack and The biosensor system according to any one of claims 1 to 4, wherein the biosensor system engages with the biosensor so as to be interlocked with movement of a lever. In the lid,
A pressing body is further provided as the holding means for holding the biosensor installed at the predetermined position by being slid between the main body portion by sliding the lever. The biosensor system according to claim 5.

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