JP5533467B2 - Biosensor system - Google Patents

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. The analyzer for quantifying the measurement target substance contained in the specimen supplied to the biosensor and the non-moisture permeable material are formed so as to be graspable, and the biosensor and the hygroscopic agent are housed in a sealed state. A sensor pack, and a locking projection that passes through the sensor pack mounted at a mounting position of the analyzer and is locked to a locked portion provided in the biosensor inside the sensor pack. and a holding means for holding the biosensor to the predetermined position of the analyzer by the projection is engaged with the engaged portion, the analyzing device, the mounting portion is formed in a concave shape A body portion and a lid portion that closes and closes the concave mounting portion so as to be openable and closable, and the mounting portion of the main body portion is provided with the locking projection of the holding means so as to be retractable and retractable, The locking projection is immersed in the main body when the concave mounting portion of the main body is open, and when the concave mounting portion of the main body is closed by the lid Projecting, penetrating through the sensor pack and locking to the locked portion of the biosensor, the sensor pack is formed with a rupture portion, and the sensor pack is ruptured when mounted at the mounting location. The biosensor held in the predetermined position by the holding means is exposed by breaking the portion and removing the sensor pack (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).

  According to the first aspect of the present invention, the sensor pack that is formed so as to be grippable by the non-moisture permeable material and in which the biosensor and the hygroscopic agent are housed in a sealed state is attached to the attachment location of the analyzer, The biosensor housed in the attached sensor pack has a locking projection of the holding means that passes through the sensor pack and locks to a locked portion provided in the biosensor inside the sensor pack. Held in place.

  Then, when the sensor pack is mounted at the mounting location, the broken portion of the sensor pack is broken and the sensor pack is removed, thereby exposing the biosensor held at a predetermined position of the analyzer by the holding means. In this way, by removing the sensor pack, the biosensor held by the holding unit is exposed at a predetermined position of the analyzer, and the specimen is supplied to the exposed biosensor so that the measurement target substance contained in the specimen is Quantified by analyzer.

  Therefore, even if the biosensor is downsized in order to reduce the manufacturing cost, when quantifying the measurement target substance contained in the sample, the user holds the sensor pack formed so as to be gripped and attaches the analyzer. The biosensor can be installed at a predetermined position of the analyzer simply by removing the sensor pack by breaking the broken portion of the sensor pack that is attached to the mounting location and removing the sensor pack. The size of the biosensor can be reduced without impairing the handleability.

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, it is possible to easily handle a miniaturized biosensor in a sensor pack for properly storing the biosensor by forming a sensor pack that holds the biosensor and the hygroscopic agent in a sealed state together. The function of can be provided. Therefore, the user can easily attach the biosensor together with the sensor pack to the mounting position of the analyzer by gripping the sensor pack, and the biosensor inside the sensor pack mounted at the mounting position of the analyzer is analyzed by the holding device. Since the biosensor is exposed by breaking the sensor pack and removing the sensor pack, the sample to be measured is supplied to the exposed biosensor. Since it can be quantified, it is not necessary to prepare a special handling tool for handling a miniaturized biosensor, and the manufacturing cost is not increased.
Further, if the concave mounting portion is closed by the lid in a state where the sensor pack is mounted on the mounting portion formed in the concave shape on the main body portion of the analyzer, the holding means provided at the mounting portion of the main body portion Since the locking projection protrudes and passes through the sensor pack mounted at the mounting location and locks to the locked portion of the biosensor, the user's finger that mounts the sensor pack at the mounting location is the locking projection of the holding means Can be prevented from touching.

  According to the second aspect of the present invention, a positioning engagement portion is provided at the mounting location of the analyzer, and the sensor pack is engaged with the positioning engagement portion when mounted at the mounting location of the analysis device. Since the engaged portion is provided, the sensor pack is attached to the analyzer by engaging the positioning engaging portion provided at the mounting location with the engaged portion provided in the sensor pack. It can be positioned accurately at the location.

It is a perspective view which shows one Embodiment of the biosensor system of this invention. It is a partial cutaway side view of the biosensor system of FIG. It is a perspective view which shows the state by which the attachment location formed in the concave shape in the main-body part of the analyzer was obstruct | occluded with the cover part. FIG. 4 is a partially cut side view of the biosensor system of FIG. 3. 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 perspective view of the biosensor system which shows the state where the attachment location was opened after the measurement target substance was quantified. It is a top view of a sensor pack. FIG. 8 is a cut side view of the sensor pack of FIG. 7. It is a principal part enlarged view of the sensor pack of FIG. It is a top view which shows the other example of a sensor pack. It is a top view which shows the other example of a sensor pack. 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 partially cut side view of the biosensor system 1 of FIG. FIG. 3 is a perspective view showing a state in which a mounting portion 103 formed in a concave shape on the main body of the analyzer 100 is closed by a lid. 4 is a partially cutaway side view of the biosensor system 1 of FIG. FIG. 5 is a perspective view of the biosensor system 1 showing a state in which the biosensor 2 is installed at a predetermined position 105 of the analyzer 100. FIG. 6 is a perspective view of the biosensor system 1 showing a state in which the mounting location 105 is opened after the measurement target substance is quantified. FIG. 7 is a plan view of the sensor pack 10. FIG. 8 is a cut side view of the sensor pack 10 of FIG. FIG. 9 is an enlarged view of a main part of the sensor pack 10 of FIG.

  As shown in FIGS. 1 and 2, the biosensor system 1 includes a biosensor 2 having an electrode system including a working electrode and a counter electrode, a reaction layer including an enzyme that specifically reacts with a measurement target substance, and a biosensor. 2 includes a sensor pack 10 that houses 2 in a sealed state, and an analyzer 100 that quantifies a measurement target substance contained in a specimen supplied to a 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 made of a noble metal such as platinum, gold, palladium, or a conductive material such as carbon, which is formed on the substrate by screen printing or sputtering. When the electrode film is subjected to pattern formation by laser processing or the like, the working electrode and the counter electrode are electrically connected to the working electrode and the counter electrode when the biosensor 2 is installed at a predetermined position of the analyzing device 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.

  Further, the biosensor 2 is provided with a locked portion 2a that is locked to a locking protrusion 106a provided at a mounting location 103 of the analyzer 100 described later.

  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 as an object and glucose oxidase to form a reducing substance is provided on the working electrode and the counter electrode that are exposed to the cavity.

(Sensor pack)
As shown in FIG. 7, the sensor pack 10 is formed so as to be grippable by a non-moisture permeable material, and the biosensor 2 and the hygroscopic agent 3 are housed in a sealed state therein. That is, as shown in FIG. 8, the sensor pack 10 includes a polyester layer of a packaging film 11 having a laminated structure including a polyethylene terephthalate layer 11a for exterior, a metal (aluminum) foil layer 11b for moisture prevention, and a polyester layer 11c for fusion. The biosensor 2 and the hygroscopic agent 3 are housed in a sealed state in an internal space formed by fusing 11c together.

  Further, the sensor pack 10 is provided with an engaged portion 12 that engages with a positioning engaging portion 104 provided at a mounting location 103 of the analyzer 100 described later. Further, the engaged portion 12 is formed at an asymmetric position with respect to the longitudinal center line of the sensor pack 10, and similarly to the positioning engaging portion 104 of the mounting location 103 formed at the asymmetric position. By aligning the engaged portion 12 and attaching the sensor pack 10 to the attachment location 103, the sensor pack 10 can be attached to the attachment location 103 without making a mistake in both sides.

  Further, the sensor pack 10 is formed with a breaking portion 13 for breaking the packaging film 11 forming the sensor pack 10. As shown in FIG. 9, the fracture portion 13 is formed by cutting only the polyethylene terephthalate layers 11 a on both surfaces of the sensor pack 10 with a carbonic acid laser or the like. At this time, since the moisture-proof metal foil layer 11b is not cut by the carbonic acid laser, the moisture-proof property of the inner space of the sensor pack is not impaired. The breaking portion 13 is formed along the locked portion 2 a provided in the biosensor 2 housed in the sensor pack 10.

  In addition, the fracture | rupture part 13 may be formed in a broken line shape as shown in FIG. 7, and may be formed in linear form. Further, the break portion 13 may be provided only on one side of the sensor pack 10. Further, the configuration of the packaging film 11 is not limited to the above-described laminated structure, and a moisture-permeable material coated with a metal foil or DLC (Diamond-like Carbon) which is a moisture-impermeable material, or non-permeable. The packaging film 11 may be formed of any material as long as moisture permeability such as a wet metal film can be ensured.

  The hygroscopic agent 3 is formed of a hygroscopic material such as zeolite or silica gel. Further, the space inside the sensor pack 10 in which the biosensor 2 is accommodated and the space in which the hygroscopic agent 3 is accommodated are continuously formed so as to be able to ventilate. The portion that communicates the space in which the biosensor 2 is stored and the space in which the hygroscopic agent 3 is stored is formed in a size that prevents the hygroscopic agent 3 from passing through, so that the hygroscopic agent 3 does not move.

  Next, an example of a method for manufacturing the sensor pack 10 will be described. First, of the two packaging films 11 forming the sensor pack 10, the biosensor 2 and the hygroscopic agent 3 are accurately positioned at a predetermined position on the fusion surface of one packaging film 11 with the other packaging film 11. Then, it is stuck with an adhesive having a weak adhesive force. Then, the other packaging film 11 is fused to cover the biosensor 2 and the moisture absorbent 3 to the one packaging film 11 to which the biosensor 2 and the moisture absorbent 3 are adhered, and the two packaging films 11 are fused. By forming a round hole as the engaged portion 12 in this state, the sensor pack 10 in which the biosensor 2 and the hygroscopic agent 3 are housed is manufactured.

  In addition, the cavity which can position and arrange | position the biosensor 2 and the hygroscopic agent 3 correctly is formed by performing hot press molding to one of the two packaging films 11 forming the sensor pack 10. May be. Alternatively, the sensor pack 10 may be formed by dividing the individual sensor packs 10 after the plurality of sensor packs 10 are integrally formed by arranging the plurality of biosensors 2 on one packaging film 11. .

(Analysis equipment)
The analyzer 100 includes a main body 101 in which a concave mounting location 103 in which the sensor pack 10 is mounted is formed, and a lid 102 that closes the concave mounting location 103 so that the concave mounting location 103 can be opened and closed. The main body 101 is rotatably connected by a hinge structure. 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. 1. At the time of mounting, the engaging portion 104 (columnar protrusion) of the mounting location 103 and the engaged portion 12 (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 12 of the sensor pack 10. However, the combination of the engaging portion 104 and the engaged portion 12 is not limited to the combination of the columnar protrusion and the round hole, and the combination of the notch and the protrusion engaging with this. The engaging portion 104 and the engaged portion 12 may have any shape as long as the sensor pack 10 can be accurately positioned at the mounting location 103 such as alignment. In addition, as described above, the engaging portion 104 is provided at the mounting location 103 at an asymmetrical position so that the sensor pack 10 can be mounted on the mounting location 103 without making a mistake.

  As shown in FIGS. 2 and 4, the front side of the main body 101, that is, a portion corresponding to the predetermined position 105, penetrates the sensor pack 10 mounted on the mounting portion 103 of the analyzer 100 and passes through the sensor pack 10. The biosensor 2 has an engaging projection 106a that is engaged with the engaged portion 2a provided in the biosensor 2 inside the pack 10, and the engaging projection 106a is engaged with the engaged portion 2a, whereby the biosensor 2 is analyzed. Holding means 106 is provided for holding at a predetermined position 105 of 100.

  The locking projection 106 a of the holding means 106 is provided at a predetermined position 105 of the mounting location 103 of the main body 101 so as to be able to move out of the main body 101. That is, as shown in FIG. 4, the holding means 106 moves to the right following the pinion 106 b that rotates in conjunction with the closing operation of the lid 102 and the pinion 106 b that rotates by the closing operation of the lid 102. A drive mechanism having a rack 106c, a pinion 106d that rotates counterclockwise following the rack 106c moving to the right, and a drive gear 106e that rotates clockwise following the pinion 106d rotating counterclockwise. I have. The driving gear 106e of the driving mechanism meshes with a gear provided at the base of the locking projection 106a, and the locking gear is engaged with the clockwise rotation of the driving gear 106e accompanying the closing operation of the lid 102. The protrusion 106 a moves upward and protrudes from the main body 101.

  Therefore, the locking projection 106 a of the holding means 106 moves upward in accordance with the closing operation of the concave mounting portion 103 of the main body 101 by the lid 102, protrudes from the main body 101, penetrates the sensor pack 10, and passes through the biosensor 2. The biosensor 2 is held at a predetermined position 105 of the analyzer 100 by being inserted into a round hole serving as the locked portion 2 a provided in the hook and being locked to the locked portion 2 a. The base portion of the locking projection 106 a functions as a pressing body that holds the biosensor 2 held at the predetermined position 105 of the analyzer 100 between the lid portion 102 and the concave shape of the main body portion 101 by the lid portion 102. When the closing operation of the mounting portion 103 is completed, the biosensor 2 installed at the predetermined position 105 of the analyzer 100 is locked by the locking projection 106a and the lid 102 by the base of the locking projection 106a. It is held and held between.

  Then, as shown in FIG. 5, the sensor pack 10 is attached to the attachment location 103 of the analyzer, and the concave attachment location 103 of the main body 101 is closed by the lid portion 102, whereby the biosensor 2 in the sensor pack 10. Is held at the predetermined position 105 by the holding means 106, the sensor pack 10 is broken along the breaking portion 13 and a part of the sensor pack 10 is removed. The biosensor 2 held at the position 105 is exposed. At this time, since the biosensor 2 is locked at the predetermined position 105 by the locking protrusion 106a, there is no possibility that the biosensor 2 is displaced when the breaking portion 13 of the sensor pack 10 is broken. Further, since the breaking portion 13 is formed along the locked portion 2a provided in the biosensor 2 positioned and accommodated inside the sensor pack 10, the locking projection 106a is formed in the bio in the sensor pack 10. In a state where the sensor pack 10 is locked to the locked portion 2 a of the sensor 2, a part of the sensor pack 10 can be broken along the broken portion 13 and easily removed.

  On the other hand, as shown in FIG. 2, if the lid 102 is rotated so as to open the mounting portion 103 of the main body 101, the pinion 106 b rotates in the opposite direction to the closing operation of the lid 102. Thus, the drive gear 106e rotates counterclockwise, whereby the locking projection 106a moves downward and is immersed in the main body 101.

  Further, an electrode (not shown) that is electrically connected to the electrode system of the biosensor 2 exposed when the sensor pack 10 is broken and removed by the breaking portion 13 is disposed at a predetermined position 105 of the main body 101. Thus, the biosensor 2 installed and held at the predetermined position 105 is electrically connected to various circuits (not shown) provided in the analyzer 100.

  In addition, the analysis apparatus 100 is automatically turned on when the sensor pack 10 is broken and removed, and it is detected that the biosensor 2 is installed at the predetermined position 105. When a specimen such as blood is supplied, measurement of a measurement target substance such as glucose in the specimen 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 101.

  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 FIGS. 1 and 2, the sensor pack 10 in which one disposable biosensor 2 is accommodated is attached to the attachment portion 103 of the main body 101 of the analyzer 100 by the user. As shown in FIGS. 3 and 4, the concave mounting portion 103 of the main body 101 is closed by the lid 102 while the sensor pack 10 is mounted on the mounting portion 103 of the main body 101.

  Subsequently, as shown in FIG. 5, part of the sensor pack 10 is broken and removed by the breaking portion 13 to detect that the biosensor 2 is installed at the predetermined position 105 of the analyzer 100. When the power is automatically turned on and a sample such as blood is supplied to the biosensor 2, measurement of a measurement target substance such as glucose in the sample 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. As shown in FIG. 6, if the user confirms the measurement result displayed on the display unit 114, the user closes the closed state of the mounting portion 103 by the lid 102 and uses the used biosensor 2 and sensor pack. What is necessary is just to remove 10 and to discard.

  As described above, according to this embodiment, the sensor pack 10 that is formed so as to be grippable by the non-moisture permeable material and in which the biosensor 2 and the hygroscopic agent 3 are housed in a sealed state is mounted on the analyzer 100. 103, and the biosensor 2 housed in the sensor pack 10 attached to the attachment location 103 has the locking projection 106a of the holding means 106 penetrating the sensor pack 10 to the biosensor 2 inside the sensor pack 10. The analyzer is held at a predetermined position 105 of the analyzer 100 by being engaged with the provided engaged portion 2a.

  Then, when the sensor pack 10 is mounted at the mounting location 103, the fracture portion 13 of the sensor pack 10 is broken and a part of the sensor pack 10 is removed, whereby the holding means 106 causes the predetermined position of the analyzer 100. The biosensor 2 held at 105 is exposed. Thus, by removing a part of the sensor pack 10, the biosensor 2 held by the holding unit 106 is exposed at the predetermined position 105 of the analyzer 100, and the specimen is supplied to the exposed biosensor 2. The measurement target substance contained in the sample is quantified by the analyzer 100.

  Therefore, even when the biosensor 2 is downsized in order to reduce the manufacturing cost, when quantifying the measurement target substance contained in the specimen, the user grasps the sensor pack 10 formed so as to be graspable, and thereby the analyzer. The biosensor is placed at a predetermined position 105 of the analyzer 100 simply by breaking the breaking portion 13 of the sensor pack 10 attached to the attachment portion 103 of the 100 and removing a part of the sensor pack 10 in a state of being attached to the attachment portion 103. 2 can be installed, the size of the biosensor 2 can be reduced without impairing the handling 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, the sensor pack 10 that stores the biosensor 2 and the hygroscopic agent 3 together in a hermetically sealed state is formed to be grippable, so that the sensor pack 10 for properly storing the biosensor 2 is reduced in size. In addition, a function for easily handling the biosensor 2 is provided. Accordingly, the user can easily attach the biosensor 2 together with the sensor pack 10 to the attachment location 105 of the analyzer 100 by holding the sensor pack 10, and the inside of the sensor pack 10 attached to the attachment location 103 of the analyzer 100. Since the biosensor 2 is held at the predetermined position 105 of the analyzer 100 by the holding means 106, the broken portion 13 of the sensor pack 10 is broken and the sensor pack 10 is removed, so that the biosensor 2 is exposed and the exposed biosensor 2 is exposed. Since the measurement target substance contained in the sample can be quantified by supplying the sample to the sensor 2, it is not necessary to prepare a special handling tool for handling the miniaturized biosensor 2. There will be no increase.

  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 12 is provided, the sensor pack 10 can be accurately positioned at the mounting location 103 of the analyzer 100.

  Further, if the concave mounting portion 103 is closed by the lid 102 in a state where the sensor pack 10 is mounted on the mounting portion 103 formed in a concave shape on the main body 101 of the analyzer 100, the mounting portion of the main body 101 is mounted. Since the locking projection 106a of the holding means 106 provided on the 103 protrudes and passes through the sensor pack 10 mounted at the mounting location 103 and locks to the locked portion 2a of the biosensor 2, the sensor to the mounting location 103 It is possible to prevent the finger of the user who wears the pack 10 from coming into contact with the locking projection 106 a of the holding means 106.

  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 of the present invention. 106 a may be provided so as to always protrude from the main body 101.

  Further, as shown in FIGS. 10 and 11, the shape of the break portion 13 formed in the sensor pack 10 is stored in the sensor pack 10 when the sensor pack 10 is broken and removed along the break portion 13. Any shape can be used as long as the biosensor 2 can be reliably exposed. For example, when the break portion 13 is formed in the sensor pack 10 as shown in FIG. 11, the sensor pack 10 is broken along the break portion 13, whereby the entire sensor pack 10 is removed from the analyzer 100. Since other configurations are the same as the configuration of the sensor pack 10 described above, the description of the configuration is omitted by giving the same reference numerals. 10 and 11 are diagrams showing another example of the sensor pack 10.

  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.

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

DESCRIPTION OF SYMBOLS 1 Biosensor system 2 Biosensor 2a Engagement part 3 Hygroscopic agent 10 Sensor pack 12 Engagement part 13 Breaking part 100 Analyzing apparatus 101 Main body part 102 Cover part 103 Installation part 104 Engagement part 105 Predetermined position 106 Holding means 106a Engagement Stop projection

Claims (2)

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 sensor pack which is formed so as to be grippable by a non-moisture permeable material, and stores the biosensor and the hygroscopic agent in a sealed state inside;
There is a locking projection that passes through the sensor pack mounted at the mounting location of the analyzer and locks to a locked portion provided in the biosensor inside the sensor pack, and the locking projection is Holding means for holding the biosensor in the predetermined position of the analyzer by locking to a locking portion;
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 freely opened and closed,
At the mounting location of the main body, the locking projection of the holding means is provided so as to be retractable,
The locking projection is immersed in the main body when the concave mounting portion of the main body is open, and when the concave mounting portion of the main body is closed by the lid Projecting, penetrating through the sensor pack and locking to the locked portion of the biosensor,
The sensor pack is formed with a break portion,
The biosensor held in the predetermined position by the holding means is exposed by breaking the broken portion of the sensor pack in a state of being mounted at the mounting location and removing the sensor pack. A biosensor system. 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.

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