JP5754195B2 - Biosensor, biosensor cartridge, measuring apparatus and measuring method - Google Patents

Description

The present invention relates to a biosensor, a biosensor cartridge for continuous measurement having the biosensor, and a measurement apparatus using the biosensor cartridge. Furthermore, the present invention relates to a method for continuously measuring a test object using these biosensors, biosensor cartridges, and measuring devices.

Biosensors using electrochemical detection means have been put into practical use as a method for quickly and easily measuring the concentration and the like of a specific component in a biological sample such as blood. An example of such a biosensor is a glucose sensor that electrochemically quantifies glucose in blood.

A glucose sensor includes an electrode system including a working electrode and a counter electrode, an enzyme, and an electron acceptor as a basic configuration. The enzyme selectively oxidizes glucose in the blood to produce gluconic acid, and at the same time reduces the electron acceptor to produce a reduced form. By applying a constant voltage to the reductant with an electrode system, the reductant is oxidized again, and current is generated at that time. Since this current depends on the glucose concentration in the blood, glucose in the blood can be quantified.

In diabetic patients requiring self-injection of insulin, control of glucose in blood, that is, blood glucose control, such as after a meal before meals, before going to bed or after waking up, and before and after insulin self-injection, is a serious life-related problem. Since the glucose sensor can be downsized, it is generally used for blood glucose self-measurement by such a diabetic patient. However, a diabetic patient using a glucose sensor has a wide range of measuring devices that can be easily measured from children to the elderly. It has been demanded.

In the conventional glucose sensor, a sensor chip having a sensor part that can be attached to the measuring device is attached to the device for each measurement. Therefore, the sensor chip is intentionally enlarged so that the patient can easily handle it. However, it is often difficult to handle an apparatus of a type in which a sensor chip is attached to the apparatus for each measurement, particularly for elderly patients. In order to eliminate such complicated handling, for example, Patent Document 1 discloses a measuring device using a biosensor sheet formed by forming a plurality of biosensors in a sheet shape as a cartridge.

JP 2003-83927 A

However, in the measuring apparatus described in Patent Document 1, the blood collecting surface on which the sensor portion is formed and the contact surface of the connector for taking out an electrical signal are arranged on the same surface, and the connector of the connector due to blood adhering thereto is arranged. Contamination and poor conduction due to blood adhering and coagulating due to multiple measurements. When such poor conduction occurs, it is impossible to accurately measure blood sugar levels, making it difficult to control blood sugar by diabetics, which may have a serious impact on the life of diabetics.

The present invention solves the above-described problems, and an object of the present invention is to provide a biosensor, a biosensor cartridge, and a measurement apparatus that can measure a plurality of times and prevent poor conduction due to blood that has adhered and coagulated. Another object of the present invention is to provide a method for continuously measuring a test object, particularly glucose in blood, using the biosensor, biosensor cartridge, and measuring apparatus.

According to one embodiment of the present invention, the apparatus includes a plurality of detection units arranged at predetermined intervals in the longitudinal direction of the first base material, and the detection units are electrically connected to the electrode system and the electrode system. The electrode system includes a working electrode and a counter electrode, and includes an enzyme reaction unit including an enzyme and an electron acceptor on the working electrode, and is folded along a line parallel to the longitudinal direction at the time of measurement. The electrode system is located on the first surface of the first base material, and at least a part of the wiring portion is located on a second surface that is spatially different from the first surface. A biosensor is provided.

The biosensor according to an embodiment of the present invention is attached by positioning a part of a wiring part for transmitting an electrical signal from an electrode system to a measuring device on a surface spatially different from the electrode system at the time of measurement. -Poor conduction due to coagulated blood can be prevented, and an accurate blood glucose level can be measured. In addition, the electrode system includes a working electrode and a counter electrode, and includes an enzyme reaction part including an enzyme and an electron acceptor located on the working electrode, so that an electric signal corresponding to the concentration of the object to be detected can be detected. .

In the biosensor, before the measurement, the electrode system and the wiring portion may be arranged on the first surface of the first base material.

The biosensor according to an embodiment of the present invention is configured so that a part of a wiring part for transmitting an electrical signal from an electrode system to a measurement device is positioned on a surface spatially different from the electrode system at the time of measurement. In this case, the electrode system and the wiring portion may be arranged on the same surface of the first base material, which makes it easy to manufacture the biosensor, and therefore it is possible to maintain high accuracy of the sensor fabrication.

In the biosensor, an angle formed by the first surface and the second surface may be 0 ° or more and less than 180 °.

The biosensor according to an embodiment of the present invention has an angle formed between a surface on which an electrode system is disposed and a surface on which a part of a wiring portion for transmitting an electrical signal from the electrode system to a measuring device is disposed. By setting the angle to 0 ° or more and less than 180 °, it is possible to prevent poor conduction due to blood that has adhered and coagulated, and an accurate blood glucose level can be measured.

In addition, according to an embodiment of the present invention, a plurality of detection units arranged at predetermined intervals in the longitudinal direction of the first base material, the detection unit is electrically connected to the electrode system and the electrode system The electrode system includes a working electrode and a counter electrode, and has an enzyme reaction unit containing an enzyme and an electron acceptor on the working electrode, and along the line parallel to the longitudinal direction at the time of measurement. The electrode system is located on the first surface of the first base material, and at least a part of the wiring portion is a second surface spatially different from the first surface. A biosensor cartridge for storing a biosensor located in a first rotation unit around which a biosensor having a detection unit before measurement is wound and a biosensor having a detection unit after measurement A biosensor car comprising: A bridge is provided.

A biosensor cartridge according to an embodiment of the present invention includes a biosensor that positions a part of a wiring portion for transmitting an electrical signal from an electrode system to a measurement device on a surface spatially different from the electrode system at the time of measurement. By housing, it is possible to prevent poor conduction due to blood that has adhered and coagulated, and an accurate blood glucose level can be measured. In addition, by providing a first rotating unit around which a biosensor having a detection unit before measurement is wound in the container, contamination of the detection unit before measurement due to blood adhesion is prevented and a detection unit after measurement By providing a recovery unit that accommodates the biosensor having the above, it is possible to prevent infection to a third party by the adhered and coagulated blood. Moreover, the electrode system of the biosensor includes a working electrode and a counter electrode, and includes an enzyme reaction part including an enzyme and an electron acceptor located on the working electrode, thereby detecting an electrical signal corresponding to the concentration of an object to be detected. be able to.

In the biosensor cartridge, the electrode system and the wiring portion may be arranged on the first surface of the first base material before measurement.

In the biosensor cartridge according to the embodiment of the present invention, a part of the wiring part for transmitting an electrical signal from the electrode system of the biosensor to the measuring device is positioned on a plane spatially different from the electrode system at the time of measurement. Therefore, before the measurement, the electrode system and the wiring part may be arranged on the same surface of the first base material, which facilitates the manufacture of the biosensor, and therefore maintains the accuracy of sensor fabrication. be able to.

In the biosensor cartridge, the biosensor may be bent so that an angle formed by the first surface and the second surface is 0 ° or more and less than 180 °.

A biosensor cartridge according to an embodiment of the present invention includes a surface on which an electrode system of a biosensor is disposed, and a surface on which a part of a wiring portion for transmitting an electrical signal from the electrode system to a measuring device is disposed. By making the angle formed between 0 ° and less than 180 °, it is possible to prevent poor conduction due to adhered and coagulated blood, and an accurate blood glucose level can be measured.

In the biosensor cartridge, the biosensor is wound around the first rotation unit in a state where the detection unit is positioned on the first surface of the first base material, and the first rotation A folding unit that folds back the biosensor that is sent out from the unit and has the detection unit before measurement may be further provided.

A biosensor cartridge according to an embodiment of the present invention includes a wiring unit for transmitting an electrical signal from an electrode system to a measurement device by including a folding unit that folds back the biosensor having the detection unit before measurement. A portion can be located on a plane spatially different from the electrode system during measurement.

In the biosensor cartridge, the recovery unit may further include a second rotating unit.

The biosensor cartridge according to an embodiment of the present invention further includes a rotation unit in the recovery unit, so that the biosensor having the detection unit after measurement can be compactly accommodated, and contamination due to adhered and coagulated blood is prevented. Can be prevented.

The biosensor cartridge may further include a connection electrode for receiving an electrical signal from the electrode system in contact with a part of the wiring portion.

The biosensor cartridge according to an embodiment of the present invention further includes a connection electrode for contacting the part of the wiring portion and receiving an electrical signal from the electrode system, thereby measuring the electrical signal from the electrode system. Can be transmitted to the device. In addition, since the biosensor and the measurement device do not directly contact each other, contamination of the measurement device with blood can be prevented.

The biosensor cartridge may further include an extrusion unit that pushes the detection unit of the biosensor to the outside of the container.

The biosensor cartridge according to an embodiment of the present invention further includes an extrusion unit that pushes the detection unit of the biosensor to the outside of the container, so that the detection unit of the biosensor is accommodated inside the biosensor cartridge except during measurement. can do. As a result, when the biosensor cartridge or the measuring device is transported or when the biosensor cartridge is attached to the measuring device, the detecting portion of the biosensor is not exposed to the outside, and the detecting portion can be prevented from being deteriorated or damaged. it can.

The biosensor cartridge may further include an extruding unit that extrudes the detection unit of the biosensor to the outside of the container, and the extruding unit may include the connection electrode.

The biosensor cartridge according to an embodiment of the present invention includes a connection electrode in the extrusion portion, whereby a portion of the wiring portion arranged on the surface of the base material opposite to the electrode system and the connection electrode are provided in the extrusion portion. Can be connected with.

According to an embodiment of the present invention, there is provided a measuring device equipped with the biosensor cartridge containing the biosensor according to any one of the above, and an operation for converting an electrical signal from the electrode system into a measured value There is provided a measuring apparatus further comprising a unit.

A measuring apparatus according to an embodiment of the present invention includes a biosensor in which a part of a wiring part for transmitting an electrical signal from an electrode system to a measuring apparatus is positioned on a surface spatially different from the electrode system during measurement. By mounting the biosensor cartridge to be accommodated, it is possible to prevent poor conduction due to blood that has adhered and coagulated, and an accurate blood glucose level can be measured. In addition, by providing the calculation unit, an electric signal from the electrode system can be converted into a measured value and provided to the measurer.

The measurement apparatus may further include a display unit that displays the measurement value.

The measurement apparatus according to an embodiment of the present invention can further provide a measurement value visually to a patient who is a measurer by further including a display unit that displays the measurement value.

The measurement apparatus may further include a driving unit that drives the rotating unit.

The measurement apparatus according to an embodiment of the present invention can further include a drive unit that drives the rotation unit, thereby moving the detection unit of the biosensor to the measurement position.

In the measurement device, the drive unit may arrange one detection unit before measurement of the biosensor at a measurement position outside the measurement device.

The measurement device according to an embodiment of the present invention can reliably measure a patient who is a measurer by disposing one detection unit before measurement of the biosensor at a measurement position outside the measurement device. Can be.

Further, according to an embodiment of the present invention, the electrode system to the first substrate, wherein the electrode system and electrically connected to the wiring part, have a, in a predetermined longitudinal direction of the first base member A plurality of detection units arranged at intervals are provided , the electrode system includes a working electrode and a counter electrode, and a biosensor including an enzyme reaction unit including an enzyme and an electron acceptor on the working electrode is used, and is parallel to the longitudinal direction. The electrode system is positioned on the first surface of the first base material, and a part of the wiring part is formed on a second surface that is spatially different from the first surface. the biosensor so as to be positioned and placed, with the sample brought into contact with the electrode system to measure the test object contained in the sample, located on the second surface side of the first substrate the A measurement method is provided, wherein an electrical signal from the electrode system is received from a part of the wiring section.

In the measuring method according to an embodiment of the present invention, a part of a wiring part for transmitting an electrical signal from an electrode system to a measuring device is positioned on a surface spatially different from the electrode system at the time of measurement. While measuring a test object by bringing a sample into contact with the system, an electrical signal from the electrode system is transmitted from a part of the wiring portion located on the second surface side while preventing poor conduction due to blood adhering or coagulating. The blood glucose level can be accurately measured.

In the measurement method, the electrode system and the wiring portion may be arranged on the first surface of the first base material before measurement.

In the measurement method according to an embodiment of the present invention, a part of a wiring part for transmitting an electrical signal from an electrode system of a biosensor to a measurement device is positioned on a surface spatially different from the electrode system during measurement. Before the measurement, the electrode system and the wiring part may be arranged on the same surface of the first base material, using a biosensor that is easy to manufacture and can maintain high accuracy of fabrication. Measurement accuracy can be maintained high.

In the measurement method, the biosensor may be bent so that an angle formed by the first surface and the second surface is not less than 0 ° and less than 180 °.

A measurement method according to an embodiment of the present invention includes a surface on which an electrode system of a biosensor is disposed and a surface on which a part of a wiring portion for transmitting an electrical signal from the electrode system to a measurement device is disposed. By making the angle formed to be 0 ° or more and less than 180 °, it is possible to prevent poor conduction due to blood that has adhered and coagulated, and an accurate blood glucose level can be measured.

In the measurement method, the biosensor is housed in a biosensor cartridge having an extruding unit, and the extruding unit pushes the detection unit of the biosensor to the outside of the biosensor cartridge so that the sample is placed in the electrode system. May be contacted.

In the measurement method according to an embodiment of the present invention, the biosensor is housed in a biosensor cartridge having an extruding portion, and the extruding portion pushes the detection portion of the biosensor to the outside of the biosensor cartridge, and the sample is applied to the electrode system. By making the contact, the detection part of the biosensor can be accommodated inside the biosensor cartridge except during measurement. As a result, when the biosensor cartridge or the measuring device is transported or when the biosensor cartridge is attached to the measuring device, the detecting portion of the biosensor is not exposed to the outside, and the detecting portion can be prevented from being deteriorated or damaged. it can.

In the measurement method, an electrical signal from the electrode system may be converted into a measurement value.

The measurement method according to an embodiment of the present invention can provide a measurement value to a patient who is a measurer by further including a calculation unit that converts an electrical signal from the electrode system into a measurement value.

In the measurement method, the biosensor cartridge may include a recovery unit and accommodate a biosensor having a detection unit after measurement.

The measurement method according to an embodiment of the present invention includes a recovery unit, so that a biosensor having a measurement unit after measurement can be accommodated, and contamination due to adhered and coagulated blood can be prevented.

According to the present invention, there are provided a biosensor, a biosensor cartridge, and a measurement device that can measure a plurality of times and prevent poor conduction due to blood that has adhered and coagulated. In addition, a method for continuously measuring a test object, particularly glucose in blood using the biosensor, the biosensor cartridge, and the measuring device is provided.

It is a figure explaining the biosensor 100 which concerns on one Embodiment of this invention, (a) shows the biosensor 100, (b) of the biosensor 100 at the time of the measurement seen from the surface where the detection part 101 is arrange | positioned. (C) shows the shape of the biosensor 100 at the time of measurement as viewed from the surface on which a part 130 of the wiring part for transmitting the electrical signal from the electrode system 10 to the measuring device is arranged. It is a schematic diagram which shows the connection of the part 130 of the wiring part which concerns on one Embodiment of this invention, and the connection electrode 520, (a) was seen from the surface where the part 130 of the wiring part of the biosensor 100 was arrange | positioned. 4B is a cross-sectional view taken along a broken line in FIG. 4A, and FIG. 4C is a diagram illustrating another example of the connection electrode 520. FIG. It is a figure explaining biosensor 100 concerning one embodiment of the present invention. It is the schematic diagram of the biosensor 100 which expanded the electrode system 10 vicinity which concerns on one Embodiment of this invention. The biosensor 200 which concerns on one Embodiment of this invention is shown, (a) shows the biosensor 200, (b) shows the shape of the biosensor 200 at the time of the measurement seen from the surface where the detection part 201 is arrange | positioned, (C) shows the shape of the biosensor 200 at the time of measurement as seen from the surface on which a part 130 of the wiring part for transmitting the electrical signal from the electrode system 10 to the measuring device is arranged. It is a schematic diagram which shows the connection of the part 130 of the wiring part which concerns on one Embodiment of this invention, and the connection electrode 520, (a) was seen from the surface where the part 130 of the wiring part of the biosensor 100 was arrange | positioned. It is a figure, (b) is sectional drawing in the broken-line part of (a). It is a schematic diagram which shows the biosensor 300 which concerns on one Embodiment of this invention, (a) shows the biosensor 300, (b) shows the biosensor 300 seen from the surface where the electrode system is arrange | positioned, (c ) Shows the biosensor 300 viewed from the side. It is a mimetic diagram showing biosensor cartridge 500 concerning one embodiment of the present invention. It is a schematic diagram of the biosensor cartridge 600 which concerns on one Embodiment of this invention, (a) shows the top view of the biosensor cartridge 600, (b) is a side view of the bending part 660 shown by the broken line of (a). Indicates. It is a schematic diagram of the guide 665 which concerns on one Embodiment of this invention, (a) is a schematic diagram of the biosensor cartridge 650 provided with the guide 665, (b) is a side view of the guide 665. It is a schematic diagram of the biosensor cartridge 700 which concerns on one Embodiment of this invention. It is a schematic diagram of the measuring apparatus 1000 which concerns on one Embodiment of this invention.

Hereinafter, a biosensor, a biosensor cartridge, a measuring apparatus, and a measuring method according to the present invention will be described with reference to the drawings. However, the biosensor, biosensor cartridge, measurement apparatus, and measurement method of the present invention can be implemented in many different modes, and are not construed as being limited to the description of the embodiments described below. . Note that in the drawings referred to in this embodiment, the same portions or portions having similar functions are denoted by the same reference numerals, and repetitive description thereof is omitted.

As a result of intensive studies to solve the above-mentioned problems, the electrode system of the detection unit of the biosensor that detects the concentration of the object to be measured in the sample and the electrical signal from the electrode system are transmitted to the measurement device. By disposing a part of the wiring part for the measurement on two spatially different surfaces at the time of measurement, the continuity of the wiring part by the sample adhering to and solidified on the electrode system, especially blood at the time of blood glucose level measurement, is reduced. The present inventors have found that this can be prevented. In addition, the present inventors have found that an accurate measurement of an object to be detected, particularly a blood glucose level, can be performed by a measurement method using a biosensor including a plurality of such detection units on a strip-shaped substrate. Hereinafter, a glucose sensor will be described as an example of a biosensor. However, the biosensor, the biosensor cartridge, the measurement device, and the measurement method according to the present invention are not limited to this, and various other than blood sugar. It can be applied to a sample and an object to be detected.

(Biosensor)
FIG. 1 is a schematic diagram showing a biosensor 100 according to an embodiment of the present invention. 1A shows the biosensor 100, FIG. 1B shows the shape of the biosensor 100 at the time of measurement as viewed from the surface on which the detection unit 101 is arranged, and FIG. The shape of the biosensor 100 at the time of measurement seen from the surface where the part 130 of the wiring part for transmitting the electrical signal is transmitted to the measuring device is shown. The biosensor 100 includes a plurality of detection units 101 on a base material 1 that is a first base material. The detection units 101 are arranged at predetermined intervals in the longitudinal direction of the base material 1.

Here, the predetermined interval at which the detection unit is arranged means that in the biosensor cartridge described later, the detection unit at the measurement position is not contaminated by blood adhered to and coagulated on the detection unit after measurement, and the measurement position This is the interval at which the detection unit before measurement is not contaminated with blood during measurement using the detection unit. Therefore, it can be arbitrarily set according to the shape of the biosensor cartridge that houses the biosensor.

The detection unit 101 includes an electrode system 10 and a wiring unit 20. The electrode system 10 includes a working electrode 11, a counter electrode 13, and a reference electrode 15. A wiring 21, a wiring 23, and a wiring 25 are connected to the working electrode 11, the counter electrode 13, and the reference electrode 15, respectively, thereby configuring the wiring unit 20. A part 130 of the wiring part for transmitting an electric signal from the electrode system 10 to the measuring device is disposed on the opposite side to one end of the wiring part 20 connected to the electrode system 10. In the biosensor 100, the wiring part 20 is bent, and the electrode system 10 and a part 130 of the wiring part are arranged in parallel on both sides of the substrate 1 in the short direction.

In FIG. 1A, a straight arrow indicates the feeding direction of the biosensor 100 when it is accommodated in the biosensor cartridge. In addition, the biosensor 100 is in a state of being folded along a broken line in FIG. 1A parallel to the longitudinal direction of the biosensor 100 at the time of measurement, that is, in the state shown in FIG. Take a sample at 10. At this time, a part 130 of the wiring part for transmitting an electrical signal from the electrode system 10 to the measuring device is disposed on the back surface of the electrode system 10 via the base material 1.

In the measurement using the biosensor 100, the connection electrode is brought into contact with a part 130 of the wiring portion arranged on the back surface of the electrode system 10 through the base material 1 shown in FIG. Is transmitted to the measuring device. FIG. 2 is a schematic diagram showing a connection between a part 130 of the wiring portion and the connection electrode 520. FIG. 2A is a view as seen from a surface where a part 130 of the wiring portion of the biosensor 100 is arranged, and FIG. 2B is a cross-sectional view taken along a broken line portion in FIG. FIG. 2C is a diagram illustrating an example of another form of the connection electrode 520.

As shown in FIGS. 2A and 2B, the biosensor 100 includes the wiring 21, the wiring 23 and the wiring 25 arranged on the back surface of the electrode system 10 through the base material 1, and the connection electrode 521. By bringing the connection electrode 523 and the connection electrode 525 into contact with each other, an electrical signal from the electrode system 10 can be transmitted to the measurement device. The connection electrode 521, the connection electrode 523, and the connection electrode 525 may be provided in any of the biosensor cartridge or the measurement device described later and, as a result, can transmit an electrical signal to the measurement device. The connection electrode 521, the connection electrode 523, and the connection electrode 525 can be smoothly brought into contact with the wiring 21, the wiring 23, and the wiring 25 by being held using an elastic body.

Further, as shown in FIG. 2C, the connection electrode 520 may be configured by arranging the connection electrode 521, the connection electrode 523, and the connection electrode 525 in parallel on the support column. When the connection electrode 520 having such a configuration is used, the wiring 21, the wiring 23, and the wiring 25 can be smoothly brought into contact without using an elastic body. In addition, the wiring 21, the wiring 23, and the wiring 25 are not necessarily limited to being arranged in parallel. What is necessary is just to arrange | position along the longitudinal direction of the base material 1 so that each may not cross | intersect another wiring.

In the present embodiment, the arrangement of the part 130 of the wiring part at the time of measurement has been described as the back surface of the electrode system 10, but the arrangement of the part 130 of the wiring part at the time of measurement is not limited to this. When the surface of the base material 1 on which the electrode system 10 is arranged is a first surface and the surface of the base material 1 on which a part 130 of the wiring part at the time of measurement is a second surface, it is shown in FIG. Thus, the angle θ formed by the first surface and the second surface may be 0 ° or more and less than 180 °. That is, at the time of measurement, the electrode system 10 and the part 130 of the wiring portion may be arranged on spatially different surfaces.

In the present embodiment, the wiring 21, the wiring 23, and the wiring 25 in the region of the part 130 of the wiring part are arranged along the feed direction of the biosensor 100. For this reason, the biosensor 100 has sufficient length of the wiring 21, the wiring 23, and the wiring 25 in the region of the part 130 of the wiring portion with the connection electrode, thereby aligning each wiring and the connection electrode. Control with respect to the feed direction of the biosensor 100 becomes easy, and the accuracy during measurement can be maintained high. Further, by arranging the wiring 21, the wiring 23, and the wiring 25 along the longitudinal direction of the base material 1 (the feeding direction of the biosensor), the connection electrode 521, the connection electrode 523, and the connection electrode 525 are arranged at positions that do not interfere with each other. Easy to do.

The substrate 1 according to the present embodiment is a substrate that supports the electrode system 10, and at least the surface on which the electrode system 10 is disposed has an insulating property. It is preferable to use a member having electrical insulation and elasticity for the substrate 1, for example, polyethylene terephthalate (PET) resin, vinyl chloride resin, polystyrene (PS) resin, polypropylene (PP) resin, polycarbonate (PC ) And the like can be suitably used. In particular, PET is excellent in material properties and processability, can reduce manufacturing costs, and is suitable for a glucose sensor used by diabetic patients with high measurement frequency.

The shape, size, and thickness of the substrate 1 can be appropriately set depending on the shape of the connection electrode of the device that is used by connecting the biosensor of the present invention. The base material 1 according to the present embodiment preferably has a strip shape with a width of 0.2 mm or more and 15.0 mm or less. More preferably, the width is 2.5 mm or more and 10.0 mm or less. By using the base material 1 having a width in this range, it is possible to realize a biosensor cartridge that can collect blood sufficient for measurement and can be mounted on a small and lightweight measuring device. The thickness of the substrate 1 is preferably 0.004 mm or more and 2.5 mm or less, and more preferably 0.006 mm or more and 0.075 mm or less. Since the base material 1 has a thickness in this range, it is easy to roll, and a biosensor cartridge that can be mounted on a small measuring device can be realized.

FIG. 4 is a schematic diagram of the biosensor 100 in which the vicinity of the electrode system 10 according to an embodiment of the present invention is enlarged. As described above, the electrode system 10 includes the working electrode 11, the counter electrode 13, and the reference electrode 15. The working electrode 11 is one electrode for applying a voltage to the reductant electron acceptor, and includes an enzyme reaction unit 17 positioned on the working electrode 11. The enzyme reaction unit 17 includes an enzyme and an electron acceptor. The enzyme reaction unit 17 may be a mixture of an enzyme and an electron acceptor, or may be a laminate of an enzyme and an electron acceptor separately. In the present embodiment, the embodiment in which the enzyme reaction unit 17 is directly disposed on the upper surface of the working electrode 11 is described. However, the enzyme reaction unit 17 is disposed so as to face the working electrode 11 through a space. Also good. The counter electrode 13 is one electrode for measuring a current flowing by electrons emitted from the electron acceptor to the working electrode 11. The reference electrode 15 is an electrode that serves as a reference when determining the potential of the working electrode 11.

For the electrode system 10, a material excellent in conductivity, corrosion resistance, smoothness and wettability is used. For example, carbon, silver (Ag), silver chloride (AgCl), gold (Au), and palladium (Pd) can be used for the electrode system 10, and carbon is particularly excellent in resistance to oxidation and corrosion, and the manufacturing cost is also high. It can be suppressed, and is suitable for a glucose sensor used by a diabetic patient whose measurement frequency is high. The electrode system 10 can be formed by a mixture of a carbon pigment and an organic binder. Examples of the carbon pigment used in the electrode system 10 according to the embodiment of the present invention include graphite, amorphous carbon, diamond-like carbon, carbon fiber, carbon black, acetylene black, ketjen black (registered trademark), carbon nanotube, and carbon nanohorn. Carbon nanofibers can be used. As the organic binder, acrylic resin, ester resin, vinyl chloride resin, vinyl chloride vinyl acetate copolymer resin, or the like can be used.

The shape, size, and thickness of the electrode system 10 can be appropriately set according to the material and the object to be detected. The electrode system 10 according to the present embodiment preferably has a rectangular shape with a width of 0.05 mm or more and 2.0 mm or less. More preferably, the width is 0.1 mm or more and 0.5 mm or less. By using the base material 1 having a width in this range, it is possible to provide an area accuracy of each electrode in the production of the biosensor and a sufficient contact space between each electrode and the sample in the measurement. Further, the thickness of the electrode system 10 is preferably 0.0005 mm or more and 2.0 mm or less, and more preferably 0.001 mm or more and 0.1 mm or less. The electrode system 10 having the thickness in this range can provide the concealability and the resistance value required for the biosensor.

The enzyme reaction unit 17 according to the present embodiment includes an enzyme and an electron acceptor. When measuring the glucose concentration, glucose oxidase (GOD) or glucose dehydrogenase (GDH) can be used as an enzyme. As the electron acceptor, potassium ferricyanide, a ferrocene derivative, a quinone derivative, an osmume derivative, or the like can be used. The enzyme and electron acceptor are used after appropriately diluted with a solvent. Examples of the solvent according to this embodiment include water, alcohol, and a water-alcohol mixed solvent. Further, it may be uniformly dispersed in a linear or cyclic hydrocarbon poor solvent. It is preferable that the enzyme and the electron acceptor are 0.3 unit or more and 10 units or less and 0.5 μg or more and 200 μg or less, respectively, per test specimen. Glucose oxidase and glucose dehydrogenase preferably have high purity, and the species of origin is not particularly limited as long as it has an activity in the above range. For example, glucose oxidase includes GLO-201 manufactured by Toyobo Co., Ltd. Can be used. The enzyme and the electron acceptor of the enzyme reaction unit 17 can obtain a reaction amount according to the amount of enzyme (titer / unit), but may be a small excess of the optimum weight part that ensures the performance of the enzyme reaction unit 17.

The enzyme reaction part 17 is preferably formed with a smaller area than the working electrode 11. For example, the enzyme reaction part 17 narrows the width in the range of 0.1 mm to 1.0 mm. The thickness of the enzyme reaction part 17 is preferably in the range of 1 μm to 100 μm. Since a detection current proportional to the area of the enzyme reaction unit 17 is obtained, the area of the enzyme reaction unit 17 is preferably set as wide as possible.

For the wiring part 20 according to the present embodiment, a material having excellent conductivity is used. Examples of the wiring portion 20 include carbon, silver (Ag), silver chloride (AgCl), gold (Au), palladium (Pd), copper (Cu), iron (Fe), aluminum (Al), and stainless steel (SUS). In particular, copper, aluminum and stainless steel are preferable from the viewpoint of the reliability of metal wiring.

The shape, size, and thickness of the wiring part 20 can be appropriately set according to the material and the object to be detected. The wiring part 20 according to the present embodiment preferably has a rectangular shape with a width of 0.05 mm or more and 2.0 mm or less. More preferably, the width is 0.1 mm or more and 0.5 mm or less. By using the wiring part 20 having a width in this range, the area accuracy of each wiring in the manufacture of the biosensor can be provided. Further, the thickness of the electrode system 10 is preferably 0.002 mm or more and 2.0 mm or less, and more preferably 0.005 mm or more and 1.0 mm. The wiring part 20 can provide the workability and reliability required for the biosensor by having a thickness in this range.

The biosensor according to the present embodiment is adhered and solidified by positioning a part of the wiring part for transmitting an electrical signal from the electrode system to the measurement device on a surface spatially different from the electrode system at the time of measurement. A poor conduction due to blood can be prevented, and an accurate blood glucose level can be measured. At this time, the angle formed between the surface on which the electrode system is disposed and the surface on which a part of the wiring portion for transmitting an electric signal from the electrode system to the measuring device is set to be 0 ° or more and less than 180 °. Thus, poor conduction due to adhered and coagulated blood can be prevented. In addition, the biosensor according to the present embodiment places a part of the wiring part for transmitting an electrical signal from the electrode system to the measurement device on a plane spatially different from the electrode system at the time of measurement. The electrode system and the wiring part may be arranged on the same surface of the first base material, which facilitates the production of the biosensor, and therefore can maintain high accuracy of the sensor fabrication.

FIG. 5 shows a biosensor 200 according to an embodiment of the present invention. 5A shows the biosensor 200, FIG. 5B shows the shape of the biosensor 200 at the time of measurement as viewed from the surface on which the detection unit 201 is arranged, and FIG. The shape of the biosensor 200 at the time of measurement seen from the surface where the part 130 of the wiring part for transmitting the electrical signal is transmitted to the measuring device is shown. The biosensor 200 includes a plurality of detection units 201 on the base material 1 that is the first base material. The detectors 201 are arranged at predetermined intervals in the longitudinal direction of the base material 1.

The detection unit 201 includes an electrode system 10 and a wiring unit 20. The electrode system 10 includes a working electrode 11, a counter electrode 13, and a reference electrode 15. A wiring 21, a wiring 23, and a wiring 25 are connected to the working electrode 11, the counter electrode 13, and the reference electrode 15, respectively, thereby configuring the wiring unit 20. A part 130 of the wiring part for transmitting an electric signal from the electrode system 10 to the measuring device is disposed on the opposite side to one end of the wiring part 20 connected to the electrode system 10. In the biosensor 200, the wiring part 20 is arranged in a straight line, and the electrode system 10 and a part 130 of the wiring part are arranged in the same straight line on both sides in the short direction of the substrate 1.

In FIG. 5A, the straight arrow indicates the feed direction of the biosensor 200 when it is accommodated in the biosensor cartridge. In addition, the biosensor 200 is in the state of being folded along a broken line in FIG. 5A parallel to the longitudinal direction of the biosensor 200 at the time of measurement, that is, in the state shown in FIG. Take a sample at 10. At this time, a part 130 of the wiring part for transmitting an electrical signal from the electrode system 10 to the measuring device is disposed on the back surface of the electrode system 10 via the base material 1.

In the measurement using the biosensor 200, the connection electrode is brought into contact with a part 130 of the wiring portion arranged on the back surface of the electrode system 10 through the base material 1 shown in FIG. Is transmitted to the measuring device. FIG. 6 is a schematic diagram showing a connection between a part 130 of the wiring portion and the connection electrode 520. FIG. 6A is a view as seen from a surface on which a part 130 of the wiring portion of the biosensor 100 is disposed, and FIG. 6B is a cross-sectional view taken along a broken line portion in FIG.

As shown in FIGS. 6A and 6B, the biosensor 200 includes the wiring 21, the wiring 23 and the wiring 25 arranged on the back surface of the electrode system 10 through the base material 1, and the connection electrode 521. By bringing the connection electrode 523 and the connection electrode 525 into contact with each other, an electrical signal from the electrode system 10 can be transmitted to the measurement device. The connection electrode 521, the connection electrode 523, and the connection electrode 525 may be provided in any of the biosensor cartridge or the measurement device described later and, as a result, can transmit an electrical signal to the measurement device. The connection electrode 521, the connection electrode 523, and the connection electrode 525 can be smoothly brought into contact with the wiring 21, the wiring 23, and the wiring 25 by being held using an elastic body.

In the present embodiment, the arrangement of the part 130 of the wiring part at the time of measurement has been described as the back surface of the electrode system 10, but the arrangement of the part 130 of the wiring part at the time of measurement is not limited to this. When the surface of the substrate 1 on which the electrode system 10 is arranged is the first surface, and the surface of the substrate 1 on which the part 130 of the wiring part at the time of measurement is arranged is the second surface, the first surface And the second surface may be at least 0 ° and less than 180 °. That is, at the time of measurement, the electrode system 10 and the part 130 of the wiring portion may be arranged on spatially different surfaces.

In the biosensor 200 according to the present embodiment, the other configurations of the substrate 1, the electrode system 10, and the wiring unit 20 are the same as those of the biosensor 100, and thus detailed description thereof is omitted.

The biosensor according to the present embodiment is adhered and solidified by positioning a part of the wiring part for transmitting an electrical signal from the electrode system to the measurement device on a surface spatially different from the electrode system at the time of measurement. A poor conduction due to blood can be prevented, and an accurate blood glucose level can be measured. At this time, the angle formed between the surface on which the electrode system is disposed and the surface on which a part of the wiring portion for transmitting an electric signal from the electrode system to the measuring device is set to be 0 ° or more and less than 180 °. Thus, poor conduction due to adhered and coagulated blood can be prevented. In addition, the biosensor according to the present embodiment places a part of the wiring part for transmitting an electrical signal from the electrode system to the measurement device on a plane spatially different from the electrode system at the time of measurement. The electrode system and the wiring part may be arranged on the same surface of the first base material, which facilitates the production of the biosensor, and therefore can maintain high accuracy of the sensor fabrication.

The biosensor 100 and the biosensor 200 described above are formed by forming the electrode system 10 and a part 130 of the wiring part on the same plane of the base material 1 and bending the biosensor parallel to the longitudinal direction of the biosensor. The biosensor has been described as an example in which the system 10 and the part 130 of the wiring part are arranged on different surfaces. The following biosensor 300 will be described as an example in which an electrode system and a wiring part are respectively arranged on the front and back of the substrate 1 and connected through a through hole.

FIG. 7 is a schematic diagram showing a biosensor 300 according to an embodiment of the present invention. 7A shows the biosensor 300, FIG. 7B shows the biosensor 300 viewed from the surface on which the electrode system is disposed, and FIG. 7C shows the biosensor 300 viewed from the side. In FIG. 7A, a straight arrow indicates the feed direction of the biosensor 300 when it is accommodated in the biosensor cartridge. The biosensor 300 includes a plurality of detection units 301 on the base material 1 that is the first base material. The detectors 301 are arranged at predetermined intervals in the longitudinal direction of the base material 1.

The detection unit 301 has an electrode system and a wiring part, and connects the electrode system and the wiring part through a through hole. The electrode system includes a working electrode 51 and a counter electrode 53, and the counter electrode 53 is disposed so as to surround the working electrode 51. The wiring part includes a wiring 61 and a wiring 63. The working electrode 51 is connected to the wiring 61 through the through hole 71. Further, the counter electrode 53 is connected to the wiring 63 through the through hole 73. Therefore, in the biosensor 300 according to the present embodiment, the electrode system and the wiring part are disposed on the opposite sides of the base material 1. Further, as described in the biosensor 100, the biosensor 300 is configured to measure the electrical signal from the electrode system by connecting the connection electrode 521 and the connection electrode 523 to the wiring 61 and the wiring 63, respectively, at the time of measurement. Can be communicated to.

In the biosensor 300, the detection unit 301 shows an example of a detection unit that functions as a reference electrode using the counter electrode 53. The detection unit 301 applies a voltage to the working electrode 51 and the counter electrode 53 using, for example, a pulse or a triangular wave voltage, performs current measurement as a counter electrode, and shifts a predetermined time to apply a voltage using the counter electrode 53 as a reference electrode. A time-resolved measurement method that applies current to measure current can be applied. Such a measurement method can be realized by switching electrodes to which a voltage is applied by a control unit provided in a measurement apparatus described later, and converting the received electrical signal into a measurement value by a calculation unit. In addition to conducting the front and back using a through-hole, the detection unit 301 may be constituted by a working electrode 51 and a counter electrode 53, and two wires connected to each electrode may be provided. The counter electrode 53 may be disposed so as to surround the working electrode 51. Such a two-pole method has a simpler electrode system configuration than a three-pole method that requires a reference electrode.

In the biosensor 300 according to the present embodiment, the other configurations of the base material 1, the electrode system, and the wiring unit are the same as those of the biosensor 100, and thus detailed description thereof is omitted.

In the biosensor according to the present embodiment, the wiring part for transmitting the electrical signal from the electrode system to the measuring device is formed on the opposite surfaces via the base material, and therefore, the biosensor is folded during measurement. In addition, it is possible to prevent poor conduction due to blood that has adhered and coagulated, and an accurate blood glucose level can be measured.

(Biosensor manufacturing method)
A method for manufacturing the biosensor 100 described in the above embodiment will be described. The wiring part 20 is disposed on the upper surface of the first base material 1. For forming the wiring portion 20, a printing method, a vapor deposition method, etching, plating, cutting, laser processing (laser tracking), or the like can be used. It can be appropriately selected according to the material of the wiring part 20.

Thereafter, the electrode system 10 is formed on the upper surface and side surfaces of the wiring part 20. The electrode system 10 can be formed by printing, vapor deposition, etching, plating, cutting, laser processing (laser tracking), or the like. It can be appropriately selected according to the material of the wiring part 20.

A solution containing an enzyme and an electron acceptor is applied to the upper surface of one working electrode 11 of the electrode thus formed by a dispenser and then dried at 40 ° C. to remove the solvent component. Thus, the enzyme reaction part 17 can be formed and the biosensor 100 can be manufactured.

(Biosensor cartridge)
A biosensor cartridge according to the present invention that accommodates the above-described biosensor will be described. FIG. 8 is a schematic diagram showing a biosensor cartridge 500 according to an embodiment of the present invention. The biosensor cartridge 500 includes a collection unit 540 and a first rotation unit 551 inside the container 510, and includes a second rotation unit 553 in the collection unit 540. The first rotating unit 551 winds and stores the biosensor 100. One end of the biosensor 100 is fixed to the second rotating unit 553 arranged in the collecting unit 540, and the measured detecting unit 101 is wound around the second rotating unit 553 and collected in the collecting unit 540.

The biosensor cartridge 500 can store the biosensor 100 in a compact manner inside the biosensor cartridge 500 by winding the biosensor 100 having the detection unit 101 before measurement around the first rotation unit 551 and storing it. it can. In addition, by providing the recovery unit 540, it is possible to prevent contamination due to adhered and coagulated blood by accommodating the biosensor 100 having the detection unit 101 after measurement. By further including the second rotation unit 553 in the recovery unit 540, the biosensor 100 including the detection unit 101 after measurement can be accommodated in a compact manner.

The biosensor cartridge 500 may include an extruding unit 530 that pushes the detection unit 101 of the biosensor 100 out of the container 510 during measurement. The arrows in the figure indicate the feed direction of the biosensor 100. For example, the extruding unit 530 can be moved back and forth in the direction of the opening of the biosensor cartridge 500 by rotating the elliptical rotating unit 535. Moreover, the extrusion part 530 may be a slide type, and is not limited to these. The biosensor cartridge 500 pushes the detection unit 101 of the biosensor 100 to the outside by the push-out unit 530, and enables sampling and detection of the detection object. By rotating the first rotation unit 551 described above, the detection unit 101 can be moved to a measurement position located at the tip of the pushing unit 530.

Although not shown, an opening / closing mechanism can be provided in the opening of the biosensor cartridge 500. The opening / closing mechanism may be a door-like mechanism that opens the biosensor cartridge 500 in the pushing direction of the pushing portion 530, or may be a slide shutter. Note that the pushing portion 530 may be fixed, and a cap with high hermeticity may be used to close the opening of the biosensor cartridge 500 except during measurement.

The biosensor cartridge 500 further includes an extruding unit 530 that pushes the detection unit 101 of the biosensor 100 to the outside, so that the detection unit 101 of the biosensor 100 can be accommodated inside the biosensor cartridge 500 except during measurement. it can. Thereby, when the biosensor cartridge 500 or the measuring device is transported or when the biosensor cartridge 500 is mounted on the measuring device, the detecting unit 101 of the biosensor 100 is not exposed to the outside, and the detecting unit 101 is deteriorated or damaged. Can be prevented.

The biosensor cartridge 500 includes a connection electrode 520 that is in contact with a part 130 of the wiring unit of the detection unit 101 of the biosensor 100 and receives an electrical signal from the electrode system 10. In the drawing, the connection electrode 520 is disposed before the push-out portion 530 with respect to the feed direction of the biosensor 100. Further, instead of the connection electrode 520, the connection electrode 529 can be disposed behind the pushing portion 530 with respect to the position of the connection electrode 529, that is, the feeding direction of the biosensor 100. When a part 130 of the wiring part is disposed on the back surface of the electrode system 10 via the base material 1 at the time of measurement, the biosensor cartridge 500 may include the connection electrode 520 in the pushing part 530. When the connection part 520 is provided in the pushing part 530, the connection electrode 520 is disposed in the vicinity of the tip part of the pushing part 530 that contacts the part 130 of the wiring part of the detection part 101. When the angle formed between the surface on which the electrode system 10 is disposed and the surface on which the part 130 of the wiring portion is disposed is greater than 0 ° and smaller than 90 °, the connection electrode 520 and the connection electrode 529 are bio- What is necessary is just to set it as the position according to the angle of the sensor 100. FIG.

The biosensor cartridge 500 further includes a connection electrode for receiving an electric signal from the electrode system in contact with a part of the wiring portion, so that the electric signal from the electrode system can be transmitted to the measuring device. . In addition, since the biosensor cartridge 500 includes the connection electrode, the biosensor and the measurement device are not in direct contact with each other, so that contamination of the measurement device with blood can be prevented.

The biosensor cartridge 500 according to the present embodiment is used for transmitting an electrical signal from the electrode system 10 to the measurement device via the substrate 1 as shown in FIGS. 1 (a) and 1 (b). The biosensor 100 may be wound around and stored in the first rotating unit 551 by bending a part 130 of the wiring unit to be disposed on the back surface of the electrode system 10. Further, the biosensor 100 may be wound and stored around the first rotating unit 551 without being bent. In this case, the biosensor 100 may be bent at the time of measurement so that the electrode system 10 and the part 130 of the wiring part are respectively arranged on two spatially different surfaces.

FIG. 9 is a schematic diagram of a biosensor cartridge 600 according to an embodiment of the present invention that includes a mechanism for bending the biosensor 100 during measurement. 9A shows a top view of the biosensor cartridge 600, and FIG. 9B shows a side view of the bent portion 660 indicated by a broken line in FIG. 9A. The biosensor cartridge 600 is different from the biosensor cartridge 500 in that the biosensor cartridge 600 includes a bending portion 660 that bends the biosensor 100 during measurement. The bending part 660 has the support | pillar 661 and the support | pillar 663, for example. In the biosensor cartridge 600, the biosensor 100 is arranged such that a part 130 of the wiring part is disposed on the back surface of the electrode system 10 while passing between the support 661 and the support 663, which are the two fulcrums of the bent part 660. Can be folded. Since the other configuration is the same as that of the biosensor cartridge 500, the description thereof is omitted.

FIG. 10 shows an example in which a guide 665 is used for the bent portion 660. FIG. 10A is a schematic diagram of a biosensor cartridge 650 including a guide 665, and FIG. 10B is a side view of the guide 665. The guide 665 has a structure in which the outlet is narrower than the inlet with respect to the feed direction of the biosensor 100. The biosensor 100 is bent along with the feed by passing through the guide 665. By using this guide part, the biosensor 100 can be folded back reliably.

Since the biosensor cartridge 600 according to the present embodiment includes the bent portion 660, the biosensor 100 can be wound and stored around the first rotating portion 551 without being bent. Therefore, the biosensor 100 is folded and stored. The bulkiness in the thickness direction when it is wound and stored in a roll shape can be reduced as compared with the case where it is performed, and more biosensors 100 can be accommodated, or the biosensors 100 can be accommodated in a smaller space. .

In the above-described embodiment, the biosensor cartridge including the second rotation unit in the recovery unit has been described. However, the biosensor cartridge according to the present invention is not limited to the one including the second rotation unit in the recovery unit. FIG. 11 is a schematic diagram of a biosensor cartridge 700 according to an embodiment of the present invention. The biosensor cartridge 700 is different from the biosensor cartridge 500 in that the collection unit 740 includes a support column 755 instead of the second rotation unit. In the biosensor cartridge 700, one end of the biosensor 100 is fixed to a support column 755 disposed in the collection unit 740. In addition, the arrow in a figure shows the feed direction of the biosensor 100. FIG.

The biosensor cartridge 700 can move the detection unit 101 of the biosensor 100 to the measurement position located at the tip of the pushing unit 530 by rotating the first rotation unit 551 in the feed direction of the biosensor 100. In addition, the biosensor 100 having the detection unit 101 after the measurement can prevent the contamination by the attached and coagulated blood by housing the recovery unit 740.

The biosensor cartridge 700 has the post-measurement detection unit 101 in the recovery unit 740 without providing a second rotating unit separately by providing the recovery unit 740 with the support column 755 to which one end of the biosensor 100 is fixed. Since the biosensor 100 can be accommodated, a reduction in size and weight can be achieved.

In the biosensor cartridge 500 and the biosensor cartridge 700 according to the above-described embodiment, the biosensor 100 is described as an example. However, the biosensor 200 or the biosensor 300 can also be stored.

(measuring device)
Hereinafter, a measuring apparatus according to an embodiment of the present invention equipped with the above-described biosensor cartridge will be described. FIG. 12 is a schematic diagram of a measuring apparatus 1000 according to the present embodiment. In FIG. 12, a measuring apparatus 1000 equipped with a biosensor cartridge 500 will be described as an example. Although not shown, measurement apparatus 1000 includes a connection electrode and a calculation unit for receiving an electrical signal generated in electrode system 10 from biosensor cartridge 500. The measuring apparatus 1000 includes a display unit 1100 and a power source.

In the measuring apparatus 1000, the connection electrode may receive an electrical signal generated in the electrode system 10 via the connection electrode 520 disposed in the biosensor cartridge 500, and the connection electrode is wired without passing through the connection electrode 520. The electrical signal generated by the electrode system 10 may be received by directly connecting to the unit 20. When the connection electrode receives an electrical signal generated in the electrode system 10 via the connection electrode 520 provided in the biosensor cartridge 500, the biosensor and the measurement device are not in direct contact with each other. Contamination due to can be prevented.

Moreover, the measuring apparatus 1000 converts the electric signal received from the electrode system 10 into a measured value by the calculating part. The obtained measurement value is displayed on the display unit 1100, and the measurer can visually recognize the measurement result.

Although not shown, measurement apparatus 1000 may further include a drive unit. The drive unit drives the first rotation unit 551 and the second rotation unit 553 arranged in the biosensor cartridge 500, and arranges one detection unit 101 before measurement of the biosensor 100 at an external measurement position. . Here, the drive unit according to the present embodiment may be a manual dial or a motor. When the drive unit is a motor, electronic control can be performed by providing a control unit. By arranging one detection unit 101 before measurement of the biosensor 100 by the drive unit at an external measurement position, it is possible to reliably perform measurement of a patient who is a measurer.

In the measuring apparatus according to the present embodiment configured as described above, a part of the wiring unit for transmitting an electrical signal from the electrode system to the measuring apparatus is positioned on a plane spatially different from the electrode system at the time of measurement. By mounting the biosensor cartridge that houses the biosensor, it is possible to prevent poor conduction due to blood that has adhered and coagulated, and to accurately measure the blood glucose level. Note that the measurement apparatus according to the present embodiment can be mounted with the biosensor cartridge 600 and the biosensor cartridge 700 in addition to the biosensor cartridge 500, and the biosensor 200 or the biosensor depending on the biosensor cartridge to be mounted. 300 can also be used.

(Measuring method)
Below, the measuring method using the measuring apparatus mentioned above is demonstrated. The biosensor cartridge containing the biosensor according to the present embodiment is provided to the measurer by the supplier. When the measuring apparatus according to the present embodiment is, for example, a blood glucose measuring apparatus, the supplier is a doctor, a hospital, a pharmacy, or the like, and the measuring person is a diabetic patient. The measurer attaches the biosensor cartridge to the measurement device. The measurer turns on the power and activates the calculation unit, the display unit 1100, the drive unit, the control unit, and the like.

It is preferable that the detection unit before the measurement is in a position where it does not come into contact with the extruding unit except when the biosensor cartridge is attached to the measurement device or during measurement. At the time of measurement, the measurer pushes out the biosensor to the outside, drives the rotation unit by the drive unit, and places one detection unit before measurement at the external measurement position. At this time, in the measuring method according to the present embodiment, a part of the wiring part for transmitting the electric signal from the electrode system to the measuring device is positioned on a plane spatially different from the electrode system at the time of measurement.

The measurer supplies a sample containing the test object to the electrode system of the detection unit. When measuring a blood glucose level, the sample is blood, and it is possible to prevent poor conduction of the wiring portion of the detection unit due to blood that has adhered and coagulated, and an accurate blood glucose level can be measured.

The electrical signal from the electrode system generated by the measurement is received from the biosensor wiring section through the connection electrode of the biosensor cartridge or directly at the connection electrode of the measurement device, and converted into a measurement value by the calculation section. . The converted measurement value is displayed on the display unit, and the measurer can recognize the measurement result.

After the measurement, the rotation unit is driven by the drive unit, and a part of the biosensor having the measurement unit after measurement is accommodated in the recovery unit, thereby preventing contamination by the adhered / coagulated blood. Since the biosensor cartridge according to the present embodiment accommodates a biosensor having a plurality of detection units, the series of measurement operations can be continuously performed a plurality of times. For this reason, it is not necessary to perform the attachment / detachment operation of the biosensor for every measurement like the past. In addition, a part of the wiring part for transmitting the electrical signal from the electrode system to the measuring device is located on a surface spatially different from the electrode system at the time of measurement, thereby preventing conduction failure due to adhered and coagulated blood. Therefore, accurate blood glucose level can be measured.

1: 1st substrate, 10: electrode system, 11: working electrode, 13: counter electrode, 15: reference electrode, 17: enzyme reaction part, 20: wiring part, 21: wiring, 23: wiring, 25: wiring, 50: Electrode system, 51: Working electrode, 53: Counter electrode, 60: Wiring part, 61: Wiring, 63: Wiring, 70: Through hole, 71: Through hole, 73: Through hole, 100: Biosensor, 101: Detection Part: 130: part of the wiring part, 200: biosensor, 201: detection part, 300: biosensor, 301: detection part, 500: biosensor cartridge, 510: container, 520: connection electrode, 521: connection electrode, 523: Connection electrode, 525: Connection electrode, 529: Connection electrode, 530: Extruding part, 535: Elliptical rotating part, 540: Recovery part, 551: First rotating part, 553: Second rotating part, 600 : Biosensor cartridge 650: biosensor cartridge 660: bent portion, 661: pillar, 663: pillar, 700: biosensor cartridge 740: recovery unit, 755: pillar, 1000: measurement apparatus, 1100: display unit

Claims (21)

A plurality of detectors arranged at predetermined intervals in the longitudinal direction of the first substrate;
The detection unit includes an electrode system and a wiring unit electrically connected to the electrode system,
The electrode system includes a working electrode and a counter electrode, and an enzyme reaction part including an enzyme and an electron acceptor on the working electrode.
At the time of measurement , the electrode system is in a state of being folded along a line parallel to the longitudinal direction, the electrode system is located on the first surface of the first base material, and at least a part of the wiring portion is the first part. A biosensor that is located on a second surface that is spatially different from the surface. The biosensor according to claim 1, wherein the electrode system and the wiring portion are arranged on the first surface of the first base before measurement. The biosensor according to claim 2, wherein an angle formed by the first surface and the second surface is not less than 0 ° and less than 180 °. Comprising a plurality of detection portions which are arranged at predetermined intervals in the longitudinal direction of the first substrate, wherein the detecting unit includes an electrode system, and electrically connected to the wiring section to said electrode system, the electrode The system includes a working electrode and a counter electrode, and has an enzyme reaction part containing an enzyme and an electron acceptor on the working electrode, and is in a state of being folded along a line parallel to the longitudinal direction at the time of measurement. Is located on the first surface of the first substrate, and at least a part of the wiring portion stores a biosensor located on a second surface spatially different from the first surface. Because
A first rotating part in which a biosensor having a detection part before measurement is wound in a container;
A biosensor cartridge comprising: a collection unit that houses a biosensor having a detection unit after measurement. 5. The biosensor cartridge according to claim 4 , wherein the electrode system and the wiring portion are arranged on the first surface of the first base before measurement. The biosensor cartridge according to claim 5 , wherein an angle formed by the first surface and the second surface is 0 ° or more and less than 180 °. In a state where the detection unit is located on the first surface of the first base material, the biosensor is wound around the first rotation unit,
The biosensor cartridge according to any one of claims 4 to 6 , further comprising a turn-back portion that turns back the biosensor that is fed from the first rotating portion and has the detection portion before measurement. . The biosensor cartridge according to any one of claims 4 to 7 , further comprising a second rotating unit in the collecting unit. The contact electrode according to claim 4 , further comprising a connection electrode that contacts a part of the wiring portion on the second surface side of the first base material and receives an electrical signal from the electrode system. the biosensor cartridge according to one or. The biosensor cartridge according to any one of claims 4 to 9 , further comprising an extruding unit that pushes out the detection unit of the biosensor to the outside of the container. An extrusion unit for extruding the detection unit of the biosensor to the outside of the container;
The biosensor cartridge according to claim 9 , wherein the pushing portion includes the connection electrode. A measuring device to which the biosensor cartridge according to any one of claims 4 to 11 is mounted,
The measuring apparatus further comprising a calculation unit that converts an electrical signal from the electrode system into a measured value. The measurement apparatus according to claim 12 , further comprising a display unit that displays the measurement value. Measurement device according to claim 12 or 13, further comprising a driving unit for driving the rotating part. The measurement device according to claim 14 , wherein the driving unit arranges one detection unit before measurement of the biosensor at a measurement position outside the measurement device. And the electrode system to the first substrate, wherein possess the electrode system and electrically connected to the wiring portion, and a plurality of detection portions which are arranged at predetermined intervals in the longitudinal direction of the first substrate, The electrode system includes a working electrode and a counter electrode, and uses a biosensor including an enzyme reaction part including an enzyme and an electron acceptor on the working electrode ,
Folded along a line parallel to the longitudinal direction, the electrode system is located on the first surface of the first substrate, and a part of the wiring portion is spatially different from the first surface. The biosensor is arranged so as to be located on the surface of 2,
A sample is brought into contact with the electrode system, and a test object contained in the sample is measured;
Some of the wiring portion located on the second surface side of the first substrate, the measurement method characterized by receiving an electrical signal from the electrode system. The measurement method according to claim 16 , wherein the biosensor has the electrode system and the wiring portion arranged on the first surface of the first base material before measurement. The measurement method according to claim 17 , wherein the biosensor is bent so that an angle formed by the first surface and the second surface is 0 ° or more and less than 180 °. The biosensor is housed in a biosensor cartridge having an extrusion part,
The measurement method according to any one of claims 16 to 18 , wherein the push-out unit pushes the detection unit of the biosensor to the outside of the biosensor cartridge to bring the sample into contact with the electrode system. . The biosensor cartridge includes a collection unit,
The measurement method according to claim 19, wherein a biosensor having a detection unit after measurement is accommodated. Measurement method according to any one of claims 16 to 20 and converting the electrical signal from the electrode system on the measurements.

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