WO2005022140A1

WO2005022140A1 - Biosensor with adhesive and peelable protective film

Info

Publication number: WO2005022140A1
Application number: PCT/JP2004/011451
Authority: WO
Inventors: Isao Karube; Masao Goto; Hideaki Nakamura
Original assignee: National Institute Of Advanced Industrial Science And Technology
Priority date: 2003-08-27
Filing date: 2004-08-10
Publication date: 2005-03-10
Also published as: JP2005069952A; JP3890417B2

Abstract

A biosensor, comprising a specimen inlet port and an air discharge port communicating with the specimen inlet port. The specimen inlet port and the air discharge port are enclosed by a protective film which can be adhered to and peeled off from the adhered surface thereof and can shield these ports from the outside of the biosensor. The biosensor does not require thermocompression bonding as an enclosing means and can easily and securely shield the inside of the biosensor from the outside before and after use. As a result, the biosensor can hold high airtightness.

Description

Specification

Biosensor having a protective film capable of bonding and peeling

Technical field

The present invention relates to a biosensor. More specifically, the present invention relates to a biosensor having a protective film that can be attached and detached.

In addition, the present invention relates to a simple packaging protective film for a biosensor. More specifically, the present invention relates to a simple protective film for biosensors that can be bonded to and peeled from the surface of the biosensor.

Further, the present invention relates to a method of using a biosensor and a biosensor device. Background art

[0002] Conventional packaging forms of disposable sensors include a method using a container, a method in which a plurality of biosensors are collectively stored in a bottle container, and a method in which one biosensor is stored in one container. (Patent Document 1). In these methods, it is possible to keep a dry state by putting a desiccant etc. in the container.

[0003] However, in the case of the former method, the number of times of opening and closing increases each time it is used, and the moisture at the time of opening reduces the dehumidifying ability of the desiccant. This type of packaging is suitable for use under humid climatic conditions like Japan. Also, it is necessary to shut off ultraviolet rays and oxygen to keep the storage condition of the biosensor in good condition. No such measure has been taken.

[0004] In the latter method, the biosensors are stored in a container one by one, so that a large amount of material must be used for packaging, and the viewpoint of effective use of limited resources and disposal of waste is required. From the point of view, it is environmentally friendly, even though it is not a packaging form.

[0005] Attempts have been made to insert a biosensor together with a desiccant between two films whose surfaces are coated with an ultraviolet absorber or a non-ultraviolet-permeable substance, and adhere the package from the outside of the film using a thermocompression bonding method. (Patent Document 2).

[0006] However, in this method, heat is applied at the time of packaging, so that the heat of processing and the accompanying thermal oxidation affect the deformation of the biosensor body and the removal of chemical substances developed in the reagent layer. In addition to the risk of deterioration and denaturation of biomaterials, it is necessary to consider the effect of heat vapor pressure to maintain a certain wet state. In addition, since the film used for packaging transmits oxygen, it cannot be expected to be effective for packaging under a nitrogen atmosphere, and has the effect of air oxidation during the storage period due to packaging in air. Furthermore, a package formed by thermocompression bonding cannot be easily opened because the adhesive part is strongly bonded with two films. For this reason, it is expected that a person with a physical disability, an elderly person, a young person, etc. may have difficulty in opening such a package in some cases.

[0007] Furthermore, in this packaging form, after the sample that may be infected is measured by the biosensor, the biosensor is returned to the opened package that originally contained the biosensor, and is discarded. However, there is a problem that the biosensor may come out of the opened package and the sample attached to the outside may adhere to another, which may cause infection.

Patent Document 1: Japanese Unexamined Patent Application Publication No. 2000-314711 · Gunze Corporation · Sensor package and method of using the same

Patent Document 2: JP-A-2003-72861Matsushita Electric Industrial Co., Ltd. 'Biosensor packaging method Invention's disclosure

Problems to be solved by the invention

[0009] In the above-described conventional method, first, in the bottle container method, there is a problem that the internal dry state cannot be maintained due to repetition of opening and closing. Further, in the method of packaging a single biosensor in a container, there is a problem that the process is complicated and many materials are required because a bulky container is used for the size of the noosensor. Furthermore, in the method of packing a single biosensor by thermocompression bonding with two films, it is not possible to eliminate the effects of heat and oxidation, even if it can block ultraviolet rays and maintain a dry state by using a desiccant. In addition, there is a problem in how to dispose of the biosensor after use of the operability and infectious sample at the time of opening the package.

That is, the present invention provides a biosensor to which a highly airtight packaging method is applied, which does not require thermocompression bonding or the like and can easily and reliably shut off the inside of the no sensor from the outside before and after use. The task is to provide Means for solving the problem

[0010] The present invention has been made in view of the above-mentioned problems, and the present inventors have proposed a method in which a sample introduction port and an air exhaust port of a biosensor are covered with a protective film having a detachable layer capable of bonding and peeling. By sealing, excellent sealing properties can be easily obtained before using the biosensor, the influence of the heat of the biosensor packaging process can be eliminated, and the sample inlet and the sample inlet can be easily used even after using the biosensor. The present inventors have found that since the air outlet can be sealed, it is possible to significantly prevent infection depending on the specimen, and thus completed the present invention.

That is, the present invention includes the following.

[0011] [1] A biosensor provided with a sample inlet and an air outlet communicating with the sample inlet, wherein the sample inlet and the air outlet can be shut off from the outside of the biosensor. A biosensor having a protective film that can be adhered to and detached from an adhesive surface.

[2] An insulating substrate, an insulating cover bonded to the substrate via a bonding layer, a protective film, and an electrode formed on the substrate in a space between the substrate and the cover. A space between the substrate and the cover is provided with a sample transport path extending from the sample inlet to the air outlet through the electrode, and the protective film includes at least the sample inlet and the sample inlet. A biosensor having a size capable of sealing an air outlet, and having a detachable layer capable of bonding to and peeling from the sample introduction port and the bonding surface where the air outlet exists.

[0013] As described above, by sealing the sample introduction port and the air discharge port of the biosensor with the protective film that can be adhered and peeled off, excellent sealing properties can be easily obtained before using the biosensor. be able to. Therefore, for example, the reaction layer can be stored for a long period of time, and the inside of the noise sensor can be controlled to a desired constant humidity.

[0014] Furthermore, since the protective film is merely adhered to the bonding surface by the detachable layer, it is possible to eliminate the influence of heat at the time of manufacturing the biosensor without using heat in the manufacturing process.

[0015] Furthermore, even after the use of the biosensor, the sample inlet and the air outlet can be easily sealed again with the peeled-off protective film, so that the sample sample can be prevented from flowing out. [0016] The sample introduction port may be formed at one end of the sample transport path or at an intermediate point as long as the sample can be injected into the sample transport path.

Such a sample transport path is patterned by the bonding layer. Examples of the bonding layer include an adhesive layer or a spacer having an adhesive layer in which an adhesive is applied to both surfaces of the spacer. Therefore, the bonding layer adheres the substrate and the cover and defines the sample transport path.

The electrode means a pair of electrodes in which a + electrode and one electrode face each other.

Such an electrode may be composed of two electrodes consisting of + and-, or may be two or more.

[3] In the biosensor, preferably, the sample inlet and the air outlet are formed on the same surface.

According to such an embodiment, the protective film is adhered to the sample inlet and the air outlet under the condition of normal temperature and normal pressure without using a packaging method involving heat such as thermocompression bonding. The inlet and the air outlet can be easily, uniformly and securely sealed to maintain a highly airtight inside.

In this specification, “on the same surface” means that all or a part of the sample inlet and the air outlet are on the same surface. The surface may be flat or curved, depending on the shape of the nook sensor. The opening directions of the sample inlet and the air outlet are not particularly limited as long as they are present on the same surface and can be covered and sealed with one protective film.

[0020] As an opening direction of the sample inlet and the air outlet, for example, both may be open in a direction perpendicular to the bonding surface (in this case, the sample inlet and the air outlet are all on the same plane). Existing), for example, the sample inlet is open in the direction perpendicular to the bonding surface, and the air outlet is open in the direction of the adhesive surface. (In this case, all of the sample inlet and the air outlet are provided.) All or a part of them are on the same plane).

In the present invention, in addition to the sample inlet and the air outlet, a sensor main part existing on the same surface, for example, a terminal, a connection part of a measuring instrument, and the like are covered with a protective film. Power S can. [4] The sample inlet and the air outlet are preferably formed on the surface of the substrate, or the sample inlet and the air outlet are preferably formed on the surface of the cover. .

[5] Further, it is preferable that the adhesion surface is a substrate surface or a cover surface.

As described above, the sample introduction port and the air discharge port only need to be present at the same time on either the surface of the substrate or the surface of the cover. That is, the adhesive surface where the sample inlet and the air outlet are present can be a substrate or a cover surface.

[6] It is preferable that a reagent layer be present on at least the electrode in the region where the sample transport path passes. According to the present invention, the reagent and the sample react when the sample sent from the sample transport path contacts the reagent layer on the electrode. This reaction is monitored as an electrical change at the electrode. One or a plurality of such reagent layers can be present on the electrode through which the sample transport path passes.

As described above, the electrode is a pair of electrodes in which the + electrode and the electrode face each other, and such an electrode may be composed of two electrode forces of + and-, or may be composed of two or more electrodes. There may be. The reagent layer is preferably present on one or both of the + electrode and the electrode.

[0025] In the present invention, a surfactant and a lipid can be coated around the sample introduction port and the surface of the sample transport path. By coating with a surfactant or lipid, the sample can be moved smoothly. Further, the tip of the sample introduction port may have a structure having a curved portion.

[7] When the biosensor of the present invention is used as a DNA chip or the like, the electrodes may be arrayed. As used herein, “array” means being arranged in an array.

[0027] The array-like biosensor has at least one sample inlet, at least one air outlet on the same surface, and can have at least one reagent layer in the sample transport path.

Further, for example, in the array-shaped biosensor, at least two or more sample transport paths branch off from one sample inlet, and the sample liquid introduced from the sample inlet is uniformly distributed in each of the sample transport paths. To reach all the reagent layers. The sample transport path may be coated with a surfactant so that the sample solution can reach all reagent layers in the array, or if the sample solution is blood, heparin-prolyxin may be used as an anticoagulant. It may be coated with a metal salt of ethylenediaminetetraacetic acid, citric acid, or the like.

[8] A desiccant and / or an oxygen scavenger may be present in the space between the substrate and the cover.

[0029] Examples of the desiccant include porous structures such as silica gel, activated alumina, calcium chloride, molecular sieves, and hygroscopic polymers.

As the oxygen scavenger, for example, a powdery substance composed of a metal such as iron and a halogenated metal, hydrosulfite, activated magnesium (for example, JP-A-2001-037457), and ascorbic acid (for example, And organic compounds such as catechol-based compounds (for example, JP-A-09-075724) and polyhydric alcohols (for example, JP-A-2003-144113). These oxygen absorbers may be, for example, supported on a carrier as known in the art (for example, JP-A-2001-037457). Commercially available oxygen scavengers include "Ageless" (trademark, manufactured by Mitsubishi Gas Chemical Company), "Vitalon" (trademark, manufactured by Toa Gosei Chemical Co., Ltd.) and the like.

[0030] Since the biosensor of the present invention is sealed with a protective film before use, for example, by including such a desiccant and / or oxygen scavenger in the biosensor, the internal dry state, Alternatively, the oxygen-free state can be maintained for a long time.

[0031] Furthermore, even when the biosensor is sealed with a protective film in an atmosphere containing moisture and oxygen at the time of packaging, the inside of the biosensor can be kept dry or deoxygenated.

[0032] Further, the inside of the biosensor can be held at a constant humidity for a long time as needed. For this reason, for example, even when the sample transfer path of the Noosensor is in a dry state, even if the sample liquid cannot be introduced smoothly, the surfactant and the like are kept on the inner wall of the sample transfer path while maintaining a constant humidity. By applying the sample, the sample can be smoothly introduced into the biosensor. When the sample solution is blood or the like, heparin, prolyxin_S, ethylenediaminetetraacetic acid, a metal salt of citric acid, or the like may be coated as an anticoagulant.

[0033] Similarly, since the reagent layer can maintain a constant humidity, the atmosphere inside the noise sensor can be maintained. Even when oxygen is present in the atmosphere, deterioration or denaturation of reagents protected by moisture due to air oxidation can be suppressed.

[0034] In the present invention, the surface of the reagent layer may be coated with a compound such as a surfactant and a lipid that facilitates movement of the sample solution. If the surface of the reagent layer is coated with a surfactant or the like, deterioration due to air oxidation can be further suppressed. If the sample solution is blood, heparin, prolyxin_S, ethylenediaminetetraacetic acid, metal salt of citric acid, etc. may be coated as an anticoagulant.

In this specification, “A and / or B” means at least one of A and B.

[9] It is preferable that the sample transport path and the desiccant and Z or the oxygen scavenger are separated by a separator.

[0036] Examples of the separator include a mesh, a filter, and a porous membrane made of a polymer such as Teflon (registered trademark) that is hydrophobic and permeable. With such a separator, direct contact between the sample moving in the sample transport path and the desiccant and / or oxygen scavenger can be prevented.

[10] The protective film may have a portion having a removable layer and a non-adhesive portion. The non-adhered portion can be used as a hook portion for peeling or re-adhering the protective film.

[11] The protective film may be bonded to the adhesive surface via a non-peeling layer that does not peel off from the adhesive surface. This makes it possible to easily and easily position the protective film when the protective film is adhered again after peeling. The type of the non-peelable layer is not particularly limited as long as the non-peelable layer has an adhesive force that does not peel off in a normal use state. The non-peelable layer is preferably made of a strong adhesive such as an epoxy-based, cyanoacrylate-based, or organic polysiloxane-based adhesive.

[12] A part of the protective film may be formed with perforations or cuts for peeling the protective film. The perforations for peeling off the protective film only need to be perforated so that they can be easily separated. Thereby, when a part or a plurality of parts of the protective film are peeled, the protective film part can be peeled along perforations or cuts. [13] A perforation for bending the protective film may be formed in a part of the protective film. When such perforations are present, it is easy to make folds along the perforations when peeling off the protective film without providing a non-peeling layer, that is, without fixing a portion that is not isolated with a strong adhesive. be able to. Therefore, handling of the biosensor at the time of measurement is facilitated, and the protective film can be easily adhered again after use. The size and shape of the perforation are not particularly limited as long as they can be easily bent and the interval and thickness are sufficient.

[14] The protective film is preferably a plastic film. Among the plastic films, polyvinylidene chloride, polyester, nylon, ethylene-vinyl alcohol copolymer, fluorine resin and the like are preferable. Such plastics have flexibility and are excellent in blocking moisture. Further, the protective film may have a single layer or a multilayer structure.

[15] A part or all of the surface of the protective film on the adhesive side may be coated with a deoxidizer or an oxygen-impermeable substance. By coating with such an oxygen scavenger or an oxygen impermeable substance, permeation of oxygen can be suppressed or blocked. In order to avoid contact between the oxygen scavenger or the oxygen impermeable substance and the outside, these are preferably formed on the bonding surface side of the protective film.

Examples of the oxygen scavenger include those similar to the oxygen scavenger. Examples of the oxygen impermeable substance include a thin film of silicon oxide, a thin film of metal such as aluminum, polyvinylidene chloride, polyester, nylon, an ethylene-vinyl alcohol copolymer, and a fluorine-based resin. The deposition of silicon oxide can be performed by a known method (Japanese Patent Laid-Open No. 7-190984).

[16] A part or the whole of the surface of the protective film may be coated with a UV absorber or a UV-impermeable substance. When coated with such an ultraviolet absorber or an ultraviolet non-transmissive substance, transmission of ultraviolet light can be suppressed or blocked.

The ultraviolet absorber is not particularly limited, but examples thereof include metals such as aluminum, halogenated metals such as silver chloride, and organic compounds such as benzotriazole. The ultraviolet non-transmissive substance is not particularly limited, but examples thereof include a vapor deposition film of a metal such as aluminum or a metal halide such as silver chloride, and a film of an organic compound such as a benzotriazole.

[17] The substrate is not particularly limited as long as it is electrically insulating, but plastic, biodegradable material, paper, or the like can be used. A preferred example of the plastic is polyethylene terephthalate. Further, the substrate may be made of a material that is impermeable to ultraviolet light.

[18] Further, the surface of the substrate may be coated with an ultraviolet absorber or an ultraviolet non-transmissive substance.

[0047] In the present invention, the cover can be made of the same material as that of the substrate as described in [16], and its surface is coated with a substance as shown in [17]. Moyore

[0048] Among the materials of the bonding layer, the spacer may be the same material as that of the substrate as described in [16], and may be a substance as described in [17]. May be coated on the surface.

[0049] In the present invention, preferably, the substrate, the cover and the spacer are coated with the ultraviolet absorbent or the ultraviolet non-transmissive substance, or the substrate, the cover and the spacer are coated with the ultraviolet absorber or the ultraviolet non-transparent substance. It is desirable to be made of an ultraviolet non-transparent material.

[19] The material of the removable layer is not particularly limited as long as the protective film can be adhered to and peeled off without damaging the surfaces of the biosensor and the protective film. As the removable layer, for example, an acrylic pressure-sensitive adhesive, a silicone-based pressure-sensitive adhesive, a rubber-based pressure-sensitive adhesive, a removable adhesive, or a double-sided tape coated with these can be used. Among them, an acrylic pressure-sensitive adhesive, a silicone-based pressure-sensitive adhesive or a rubber-based pressure-sensitive adhesive is more preferable, and an acrylic pressure-sensitive adhesive or a silicone-based pressure-sensitive adhesive is more preferable. As the pressure-sensitive adhesive, a pressure-sensitive adhesive containing these as a main component can be preferably used.

As the acrylic pressure-sensitive adhesive, for example, a pressure-sensitive adhesive mainly containing an acrylate such as methyl acrylate or ethyl acrylate is preferable.

As the silicone-based pressure-sensitive adhesive, a pressure-sensitive adhesive mainly containing dimethylpolysiloxane or the like is preferable. [0052] The acrylic pressure-sensitive adhesive and the silicone-based pressure-sensitive adhesive can be easily synthesized into a uniform one according to the purpose, and are stable to ultraviolet rays, oxygen, and chemicals. it can.

[20] The protective film can be adhered to an adhesive surface. The case where the protective film is bonded to the bonding surface includes before and after the use of the biosensor according to the present invention.

[0053] The electrode can be composed of any one of carbon, silver, silver / silver chloride, platinum, gold, nickel, copper, nadium, titanium, iridium, lead, tin oxide, and platinum black. As the carbon, carbon nanotube, carbon microcoinole, carbon nanohorn, fullerene, dendrimer or a derivative thereof can also be used.

Such an electrode can be formed on a substrate or a cover by any of a screen printing method, an evaporation method, a sputtering method, a foil sticking method, and a plating method.

[0054] The adhesive layer that can serve as the bonding layer can also be formed by a screen printing method. Further, the adhesive layer may contain a reagent such as an enzyme-mediator or a surfactant.

[0055] The reagent layer includes enzymes, antibodies, nucleic acids, primers, peptide nucleic acids, nucleic acid probes, microorganisms, onoreganella, receptors, cell tissues, molecular identification elements such as crown ethers, mediators, intercalators, coenzymes, antibodies. Any one of or a combination of a labeling substance, a substrate, an inorganic salt, a surfactant, and a lipid or a combination thereof can be appropriately contained depending on a test target by a biosensor.

When the sample liquid is blood or the like, an anticoagulant may be contained. Examples of the anticoagulant include heparin, prolyxin_S, ethylenediaminetetraacetic acid, metal salts of citric acid, and the like.

[0056] Examples of the enzyme include enzymes such as oxidase and dehydrogenase, for example, dalcos oxidase, fructosylamine oxidase, lactate oxidase, urate oxidase, cholesterol oxidase, alcohol oxidase, glutamate oxidase, pyruvate oxidase, and glucose dehydrogenase. , Lactate dehydrogenase, anoreconeole dehydrogenase, cholesterol monoleesterase; protease, pinorebi Acid oxidase, peroxidase, glucose dehydrogenase, lactate dehydrogenase, anoreconorele dehydrogenase, cholesterol monoolesterase, inorganic pyrophosphatase, maltose phosphorylase, mutarotase, catalase

Ligase such as protease, DNase, and restriction enzyme such as DNA ligase.

These can be used alone or in combination of two or more.

[0057] Further, the reagent layer may be contained as a combination of mediators that are not enzymes alone. This mediator is selected from potassium ferricyanide, phlegmene, and benzoquinone power. The reagent layer may contain a combination of inorganic salts such as sodium salt sodium and potassium salt sodium and quinhydrone.

[0058] The reagent layer may contain a combination of a primer, a DNA polymerase, and deoxyribonucleotide triphosphate. Further, the reagent layer can contain quinhydrone in combination with an inorganic salt such as sodium chloride, potassium chloride, and the like, in addition to primer, DNA polymerase, and deoxyribonucleotide triphosphate.

[0059] When the biosensor is used as a DNA chip, it can immobilize a nucleic acid probe as a reagent layer. In this case, it is preferable to arrange the electrodes in an array.

[0060] The reagent layer is formed by a screen printing method or a dispenser method, and the reagent layer can be immobilized on the electrode surface or the substrate surface by an adsorption method involving drying or a covalent bonding method.

[0061] Such a reagent layer is not limited to one location, and may be provided at two or more locations. In this case, two or more different types of reagent layers may be provided. When two or more reagent layers are provided, a convex partition may be provided between them. This convex partition part can be formed by a screen printing method. The partitioning portion of the projection can be made of any one of carbon, a resist and a water-absorbing material.

[21] A plurality of the biosensors may be regularly arranged at predetermined intervals, and perforations may be provided on a substrate of the connected biosensors.

With this configuration, a large number of biosensors can be efficiently manufactured at once. In addition, each of the connected biosensors (sensor unit) can be connected to the measurement unit. Thus, a measuring device capable of simultaneously measuring a large number of samples can be obtained. Further, in this configuration, since a plurality of sensor units are regularly arranged at predetermined intervals, each sensor unit can be sequentially moved by rotating or the like and connected to a measuring instrument. With such a measuring device, it is possible to continuously and automatically measure a large number of samples. Further, by providing perforations on the connected electrode sheets (substrates), it is possible to reduce the storage space, to fold the connected biosensors and to separate individual electrodes.

[22] The biosensor package according to the present invention contains a plurality of the biosensors.

More specifically, a plurality of the easily packaged biosensors of the present invention can be packaged together by a bottle container system or a box container system.

[0064] Further, the plurality of biosensors of the present invention are housed in a box-shaped container system or the like in a well-organized state in a container, and the biosensors are taken out of the container in order. Alternatively, the serial number of each biosensor or the remaining number of biosensors in the container can be printed on the protective film.

[23] The simple packaging protection film for a biosensor according to the present invention is a protection film for simple packaging of a biosensor having a sample inlet and an air outlet communicating with the sample inlet. The sample inlet and the air outlet can be shut off from the outside of the biosensor, and can be adhered to and separated from the surface of the biosensor. Such a protective film can be preferably used for the biosensor of the embodiment described in [2]-[21].

[24] The method for using the biosensor of the present invention includes a sample inlet and an air outlet communicating with the sample inlet, and the sample inlet and the air outlet are connected to the outside of the biosensor. A method of using a biosensor having a protective film that can be blocked,

When the biosensor is used, part or all of the protective film is peeled off from the biosensor, and after the biosensor is used, the peeled protective film is adhered again to the surface of the biosensor, and the sample inlet and the air outlet are removed. It is characterized by being covered with the protective film and sealed. In such a method of using a biosensor, the biosensor of the embodiment described in the above [2]-[21] can be preferably used.

[25] A biosensor device according to the present invention includes the biosensor according to any one of [1] to [21],

A measuring unit that measures an electric value of the electrode of the biosensor,

A display unit that displays a measurement value in the measurement unit;

A memory unit for storing the measurement value.

One of the potential step chronoamperometry, coulometry, and cyclic voltammetry is used as a measurement method in this measurement unit. In addition, this device can be equipped with Bluetooth as a wireless means.

The invention's effect

[0068] The biosensor of the present invention can be easily manufactured without the need of manufacturing by a method such as thermocompression bonding, and can improve the yield. In addition, it has excellent hermeticity, can eliminate the influence of oxidation of the reagent layer in the biosensor, and has excellent long-term storage stability. In addition, the easy attachment and detachment of the protective film makes it extremely easy to use, especially for users with physical disabilities (users), and the biosensor can be easily sealed after use, making it extremely hygienic. It is. When the configuration, materials, a series of manufacturing methods, and the like are evaluated, the biosensor of the present invention can significantly reduce the burden on the environment at the time of manufacturing and after use as compared with a conventional disposable biosensor. Brief Description of Drawings

[FIG. 1] FIG. 1 shows the packaging of a protective film in a biosensor (a structure in which the opening directions of a sample introduction port and an air discharge port are formed in the same direction and on the same surface) of the present embodiment. Here are some typical examples. Figure la is an example of the bonding surface side of the substrate with the wiring pattern on the substrate, Figure lb is an example of the bonding surface side of the cover with the spacer, and Figure lc is the biosensor with the substrate and the cover bonded together Figure Id shows an example of a biosensor to which a protective film is further adhered, Figure le shows an example of use, and Figure If shows an example after use. Figure lg shows an example of an enlarged cross-sectional view taken along the line AA of Figure Id. [FIG. 2] FIG. 2 shows a biosensor of the present embodiment (a structure in which the opening direction of the sample inlet is perpendicular to the cover surface, and the opening direction of the air outlet is formed on the same surface in the cover surface direction). 2 shows an example of packaging of a protective film into a protective film. Fig. 2a is an example of the bonding surface side of a substrate having a wiring pattern on the substrate, Fig. 2b is an example of the bonding surface side of a cover having a spacer, and Fig. 2c is a biosensor in which the substrate and the cover are bonded. 2d shows an example of a biosensor to which a protective film is further adhered, FIG. 2e shows an example of use, and FIG. 2f shows an example after use. FIG. 2g shows an example of an enlarged view of the BB section of FIG. 2d.

[FIG. 3] FIG. 3 shows an example of packaging of a protective film in a biosensor (a structure in which the opening directions of a sample introduction port and an air discharge port are formed in the same direction and on the same surface) according to the present embodiment. Show. Fig. 3a is an example of a development view of a biosensor. Fig. 3a- (1) shows an example of a bonding surface side of a substrate having a wiring pattern on the substrate. Fig. 3a- (2) has a spacer. This is an example of the bonding surface side of the cover, where i is located on the opposite side of the sample transport path across the air outlet, and ii is the opposite side of the desiccant across the air outlet of the sample transport path and the sample. M is an example of a pattern in which a desiccant is placed inside the spacer and all around the sample transport path, and m is placed on the spacer separated by the transport path. FIG. 3b shows an example of a plan view of a biosensor in which a substrate and a cover are bonded together, FIG. 3c shows an example of a biosensor further bonded with a protective film, and FIG. 3d shows an example of an enlarged cross-sectional view taken along the line CC of FIG. 3c.

[FIG. 4] FIG. 4 shows an example of packaging of a protective film in a biosensor (a structure in which the opening directions of a sample inlet and an air outlet are formed in the same direction and on the same surface) of the present embodiment. Show. Fig. 4a shows an example of a configuration diagram of a biosensor, Fig. 4b shows an example of a biosensor to which a protective film is adhered, Fig. 4c shows a use example, and Fig. 4d shows an example after use.

[FIG. 5] FIG. 5 shows an example of packaging of a protective film in a biosensor (a structure in which the opening directions of a sample introduction port and an air discharge port are formed in the same direction and on the same surface) of the present embodiment. Show. FIG. 5a shows an example of a configuration diagram of a biosensor, FIG. 5b shows an example of a biosensor with a protective film bonded thereto, FIG. 5c shows an example of use, and FIG. 5d shows an example after use.

[FIG. 6] FIG. 6 shows an example of packaging of a protective film in the biosensor (a structure in which the opening directions of the sample inlet and the air outlet are formed in the same direction and on the same surface) of the present embodiment. Show. Fig. 6a is an example of a configuration diagram of a biosensor, and Fig. 6b is 6c shows an example of use, and FIG. 6d shows an example after use.

[FIG. 7] FIG. 7 shows an example of packaging of a protective film in a biosensor (a structure in which the opening directions of a sample inlet and an air outlet are formed in the same direction and on the same surface) of the present embodiment. Show. FIG. 7a shows an example of a configuration diagram of a biosensor, FIG. 7b shows an example of a biosensor with a protective film bonded thereto, FIG. 7c shows an example of use, and FIG. 7d shows an example after use.

[FIG. 8] FIG. 8 shows an example of packaging of a protective film in a biosensor (a structure in which the opening directions of a sample inlet and an air outlet are formed on the same surface in the same direction) of the present embodiment. Show. Fig. 8a shows an example of a configuration diagram of a biosensor, Fig. 8b shows an example of a biosensor to which a protective film is adhered, Fig. 8c shows an example of use, and Fig. 8d shows an example after use.

[FIG. 9] FIG. 9 shows an example of packaging of a protective film in a biosensor (a structure in which the opening directions of a sample inlet and an air outlet are formed in the same direction and on the same surface) of the present embodiment. Show. Fig. 9a shows an example of a configuration diagram of a biosensor, Fig. 9b shows an example of a biosensor with a protective film bonded thereto, Fig. 9c shows an example of use, and Fig. 9d shows an example after use.

[FIG. 10] FIG. 10 shows an example of packaging of a protective film in the biosensor (a structure in which the sample introduction port and the air discharge port are formed in the same direction and on the same surface) according to the present embodiment. Is shown. Fig. 10a shows an example of the configuration of a biosensor, Fig. 10b shows an example of a biosensor with a protective film adhered, Fig. 10c shows an example of use, and Fig. 10d shows an example after use.

FIG. 11 shows an example of another biosensor (a structure in which the opening directions of the sample introduction port and the air discharge port are formed in the same direction on the same surface) in the present embodiment. 11a and 11b show examples of the configuration of a biosensor having two sample transport paths, and FIG. 11c shows an example of the configuration of a biosensor having four sample transport paths.

FIG. 12 shows an example of another arrayed biosensor (a structure in which the opening directions of the sample inlet and the air outlet are formed in the same direction and on the same surface) in the present embodiment. FIG. 12a— (1) is an example of a bonding surface side of a substrate having a wiring pattern on the substrate, FIG. 12a_ (2) is an example of a bonding surface side of a cover having a spacer, and FIG. An example of a plan view of an arrayed biosensor in which a substrate and a cover are bonded together, and FIG. 12c shows an example of an arrayed biosensor further bonded with a protective film.

FIG. 13 shows another arrayed biosensor (sample inlet and air) of the present embodiment. (A structure in which the opening direction of the discharge port is formed on the same surface in the same direction). Fig. 13a- (1) is an example of the bonding surface side of a substrate having a wiring pattern on the substrate, Fig. 13a- (2) is an example of the bonding surface side of a cover having a spacer, and Fig. 13b is FIG. 13c shows an example of a plan view of an arrayed biosensor in which a substrate and a cover are bonded together, and FIG. 13c shows an example of an arrayed biosensor further bonded with a protective film.

FIG. 14 shows an example of another arrayed biosensor (a structure in which the opening directions of the sample introduction port and the air discharge port are formed in the same direction and on the same surface) in the present embodiment.

. FIG. 14a— (1) is an example of a bonding surface side of a substrate having a wiring pattern on the substrate, FIG.

_ (2) is an example of the bonding surface side of a cover having a spacer, FIG. 14b is an example of a plan view of an arrayed biosensor in which a substrate and a cover are bonded, and FIG. 14c is a further protective film. An example of an array-shaped biosensor to which is adhered is shown.

FIG. 15 shows an example of an articulated biosensor provided with a protective film.

[FIG. 16] FIG. 16 shows an example of a box-shaped container for storing a biosensor provided with a protective film.

[FIG. 17] FIG. 17 shows a display example of the remaining number applied to the protective film portion of the connection type sensor.

Explanation of symbols

2 Cover

3 Spacer

4 Pattern including electrodes

5 terminals

6 Spacer space

7 Sample transfer path

8 Sample inlet

9 Air outlet

Ten

11 Protective film 12 Removable layer

13

14 Sample liquid

15 Through hole

16 Desiccant

17 Perforations

18

19 cut

20 Biosensor

21 valley

22 Lid

23 Part with removable layer

24 Part with strong adhesive layer

25 electrodes

26 Number of remaining biosensors

BEST MODE FOR CARRYING OUT THE INVENTION

Hereinafter, the present invention will be described with reference to examples, but the present invention is not limited to the examples.

FIG. 1 shows a representative example of the biosensor of the present invention. FIG. 1 is an example of a plan view of a biosensor of the present invention in which a sample inlet and an air outlet are formed on the same surface.

FIG. La shows a substrate 1 of a typical biosensor, a pattern 4 including electrodes on the substrate, and a reagent layer 10. The pattern 4 including the electrodes is bent at the lower end of the drawing into an L-shape, and the L-shaped portion is orthogonal to the reagent transport path 7 described later. In addition, a reagent layer 10 can be provided on the L-shaped portion of the pattern 4 including this electrode as needed.

FIG. Lb shows an example of a side surface of the cover 2 connected to the substrate 1. On the cover 2, a spacer 3 is formed as a bonding layer, and an empty portion 6 of the spacer corresponding to the sample transfer path 7 is formed. Has formed.

The spacer 3 may be a spacer material having both sides provided with an adhesive layer. As the bonding layer, an adhesive layer may be used in addition to the spacer. The bonding layer composed of the spacer 3 has a role of defining the sample transport path 7 in addition to a role of bonding and fixing the substrate 1 and the cover 2.

Further, a sample introduction port 8 for injecting the sample liquid 14 and an air exhaust port 9 for exhausting air in the sample transport path 7 are formed at both ends of the sample transport path 7, so that the sample inlet port is provided. Through holes 15 corresponding to the air outlet 8 and the air outlet 9 are provided at both ends of the empty portion 6 of the spacer.

FIG. Lc is a diagram in which the cover 2 is coupled to the substrate 1 of FIG. The terminal 5 which is a part of the electrode pattern remains on the surface of the substrate 1. A sample inlet 8 and an air outlet 9 are provided on the surface of the cover 2. Although not shown in FIG. Lc, a sample introduction port 8 and an air exhaust port 9 of the biosensor can be formed on the substrate 1 in a similar production method.

FIG. Id shows a plan view of the biosensor 20 of the present invention. The cover 2 is wrapped with a protective film 11. In this case, since the sample introduction port 8 and the air exhaust port 9 are formed on the same surface of the cover 2, the protective film 11 is formed by the detachable layer 12 as shown in FIG. It can be easily packaged with its surface uniformly and closely contacted.

For this reason, the inside of the sensor is completely shut off from the outside atmosphere, and the airtightness can be maintained. Further, the non-adhesive portion 13 in the protective film 11 can cover the terminal portion 5 and can be used as a knob when the protective film 11 is peeled off.

FIG. Le shows an example of use of the biosensor for detection and the like. The non-adhesive portion 13 of the protective film 11 can be pinched from the biosensor to peel off the portion 23 having the removable layer 12. The biosensor from which the protective film 11 has been peeled off in the vertical direction brings the sample liquid 14 to be measured into contact with the sample inlet 8 and sucks up the sample liquid 14. The drawn sample liquid 14 comes into contact with the reagent layer 10 shown in FIG. The chemical layer 10 reacts with a target component in the sample solution 14 and detects an electrochemical change such as a potential or an electric current caused by the reaction with an electrode. When there is no reagent layer 10, the target component is detected only by the electrode.

FIG. If shows an example after using the biosensor. After the biosensor is used for inspection, etc., the protective film 11 wrapped before using the biosensor is used to close the sample introduction port 8 and air exhaust port 9 on the same plane of the cover 2. By reattaching the sample to a biosensor, a sample solution that may be infected, for example, blood, can be used for the test and then retained inside the biosensor in a state where it is isolated from the outside world. The sample solution used in this case is not limited to an infectious sample solution, but may also include other chemically or physiologically dangerous sample solutions. The used biosensor thus repackaged can eliminate the risk of infection and contact with dangerous substances by eliminating the leakage of the sample solution.

FIG. Lg is an example of an enlarged cross-sectional view taken along line AA of FIG. Id. A pattern 4 including an electrode and a spacer 3 are formed on the surface of the substrate 1, and a cover 2 is further coupled via the spacer. A sample transfer path 7 is formed by the spacer 3. Further, an air outlet 9 is formed so as to penetrate the cover 2. A protective film 11 is adhered on the cover 2 by a removable layer 12.

FIG. 2 shows a biosensor in which the sample inlet 8 is formed on the cover surface perpendicular to the cover surface, and the air outlet 9 is open at the end of the cover in the cover surface direction. I have.

FIG. 2a shows the substrate 1 of the biosensor, the pattern 4 including the electrodes on the substrate, and the reagent layer 10.

FIG. 2B shows an example of the surface of the cover 2 on the side to be bonded to the substrate 1. On the cover 2, a spacer 3 is formed as a bonding layer, and an empty portion _{6 of the} spacer corresponding to the sample transfer path 7 shown in FIG. 2g is provided. Also, a through hole 15 corresponding to the sample inlet 8 is provided. The air outlet 9 is formed at an end of the spacer-free portion 6 opposite to the through hole 15.

FIG. 2C is a diagram in which the cover 2 is combined with the substrate 1 in FIG. 2A. The terminal 5 which is a part of the pattern including the electrode remains on the surface of the substrate 1. In addition, the sample An inlet 8 is provided, and an air outlet 9 opened in the cover surface direction is formed at the end of the cover of the sample transfer path 7 in FIG. 2g.

FIG. 2d shows an example of the biosensor 20 of the present invention. In this case, the protective film 11 seals the sample inlet 8 and the air outlet 9 on the plane of the cover 2 with the portion 23 having the removable layer 12.

In this case, the air discharge port 9 is sealed by thickening the removable layer 12, or the step between the substrate 1 and the cover 2 other than the air discharge port 9 is carried with a putty or a removable adhesive. Thereby, the airtightness at the time of packaging can be more reliably maintained.

Thus, the portion 23 having the removable layer 12 adheres the entire cover 2 and the part of the substrate 1 where the electrode terminals 5 are exposed, and the non-adhesive layer 13 has the electrode terminals 5 where the electrode terminals 5 are exposed. An end portion of one biosensor can be covered. By doing so, the non-adhesive layer 13 can be used as a knob when the protective film 11 is peeled off from the biosensor in the vertical direction. FIG. 2e shows an example of using the biosensor, and FIG. 2f shows an example after using the biosensor.

FIG. 2g is an example of an enlarged cross-sectional view taken along the line BB of FIG. 2d. A pattern 4 including an electrode and a spacer 3 are formed on the surface of the substrate 1, and a cover 2 is further coupled via the spacer. A sample transfer path 7 is formed by the spacer 3. The protective film 11 is adhered to the cover 2 by the removable layer 12.

FIG. 3 shows an example in which a desiccant 16 is incorporated in the biosensor 20 of the present invention, and the biosensor is packaged with the simple packaging protection film 11.

FIG. 3a shows a development view of the biosensor. Fig. 3a- (l) shows the substrate 1, and Fig. 3a- (2) shows the cover 2 and the spacer 3.

There are two through holes 15 on the cover 2 in Fig. 3a_ (2), which are used when the substrate 1 in Fig. 3a_ (l) and the cover 2 and spacer 3 in Fig. 3a_ (2) are bonded together. Then, a sample inlet 8 and an air outlet 9 are formed.

3a- (2) -i shows an example in which the desiccant 16 is placed on the opposite side of the sample transport path 7 across the air outlet 9 on the cover 2, and FIG. 3a- (2) -ii shows the desiccant 16 Is located on the facer across the through hole 15 corresponding to the air outlet 9 of the spacer empty space 6 (corresponding to the sample transfer path 7) and on the spacer 3 across the spacer empty space 6. Figure 3a— (2) —iii is the desiccant In the example shown in the figure, the spacers are arranged inside the spacer 3 and all around the empty space 6 of the spacer.

[0084] A biosensor shown in Fig. 3b is formed on the cover 2 by bonding a substrate having the desiccant 16 arrangement pattern of Fig. 3a- (2) -i-iii with the substrate 1.

Here, the biosensor incorporating the desiccant 16 is not limited to the shape shown in FIG. 3, but a sample inlet 8 is formed on the cover surface so as to be perpendicular to the cover surface, and an air outlet 9 is provided at the end of the cover. The present invention is applicable to a biosensor having an opening in a direction or an array of biosensors, and is not limited to the biosensor shown in FIG.

Further, FIG. 3 shows a case where only the desiccant 16 is used. The present invention is not limited to the force desiccant alone, and an oxygen scavenger or an oxygen scavenger and a desiccant may be used in place of the desiccant.

FIG. 3c shows an example of the biosensor 20 of the present invention. In this case, the protective film 11 is a force wrapped so as to cover the entire top surface of the cover 2 of the biosensor 20. The present invention is not limited to this wrapping form, and can be applied to various wrapping forms such as FIGS. .

According to this packaging method, the inside of the biosensor can be kept dry or oxygen-free for a long time. In order to keep the oxygen-free state, a protective film 11 is formed, and a thin film of silicon oxide or a thin metal film of aluminum or the like can be formed on the bonding surface of polychlorinated vinylidene or polyester. It is possible to use a film formed by vapor deposition.

FIG. 3D is an example of an enlarged cross-sectional view taken along the line CC of FIG. 3C. A pattern 4 including electrodes, a spacer 3, and a desiccant 16 are provided on the surface of the substrate 1, and the cover 2 is further coupled via the spacer. A sample transfer path 7 is formed by the spacer 3. Further, an air outlet 9 is formed so as to penetrate the cover 2. The protective film 11 is adhered to the cover 2 by the removable layer 12.

FIG. 4 to FIG. 10 show various forms of forming a protective film of the biosensor 20 of the present invention. In all of the biosensors shown in these figures, the sample inlet 8 and the air outlet 9 are formed on the same surface of the cover 2, but the shape of the biosensor adapted to the packaging form of the present invention is Is not limited to this, and may be, for example, the form shown in FIG. In addition, the present invention can be applied to the shape of an array-shaped biosensor to be described later. FIGS. 4 and 8 show an example of a mode in which the protective film 11 wraps the entire upper surface of the biosensor 20. FIG.

[0089] Figs. 4 and 5 show that the protective film 11 is adhered and fixed to the lower end of the upper surface of the biosensor as a strong adhesive layer 18, and when the biosensor is used, the protective film 11 peels off from the upper end of the biosensor to the lower end. Show the case.

As shown in FIGS. 4b, c and 5b, c, a perforation 17 is formed on the boundary between the portion 24 having the strong adhesive layer 18 and the portion 23 having the removable layer 12 in the protective film 11. ing. When the protective film 11 is peeled down in the vertical direction to the perforations 17, a complete fold is formed at the perforations 17. Thereby, as shown in FIG. 4c, since the protective film 11 warps from the biosensor surface, there is no need to worry about interfering with the operation of introducing the sample during measurement.

Further, in FIG. 4d, since a part of the protective film 11 is fixed to the biosensor, when the used protective film 11 is repositioned to the original state, the positioning has already been performed. FIG. 5 shows a case where a part of the protective film 11 of the biosensor 20 is partially peeled along the cut 19 in FIG. . In this case, for example, perforations 17 can be provided instead of the cuts 19 as shown in FIG. 5b. In some cases, the cut 19 or the perforation 17 may not be provided.

FIG. 6 and FIG. 7 show that the protective film 11 is adhered and fixed to the upper end of the upper surface of the cover 2 of the biosensor 20 at the portion 24 having the strong adhesive layer 18. Indicates a case where the biosensor peels from the lower end to the upper end of the biosensor. As in FIGS. 4 and 5, the boundary between the portion 24 having the strong adhesive layer 18 and the portion 23 having the removable layer 12 is perforated 17.

As shown in FIGS. 6c and 7c, when the protective film 11 is peeled up to the perforations 17 in the longitudinally upper direction, the perforations 17 completely break the portion. The operation at the time of measurement and after the measurement can be performed simply and reliably, as in the description of FIG. 4 and FIG. FIG. 7 shows a case where a part of the protective film 11 of FIG. Indicates a match. In this case, a perforation 17 can be provided instead of the cut 19, and in some cases, the cut 19 or the perforation 17 need not be provided.

FIG. 8 to FIG. 10 show a case where the protective film 11 wrapped on the upper surface of the biosensor 20 is peeled in the lateral direction with respect to the biosensor.

FIG. 8B shows a form in which the protective film 11 is packaged so as to protrude from the entire top surface and side surfaces of the biosensor 20. In this case, the entire surface of the cover 2 of the sensor 20 is adhered at a portion 23 having a removable layer of the protective film 11, and the remaining portion protruding to the side of the biosensor is a non-adhesive layer 13, and the protective film 11 is Can be used as a knob for peeling. In Fig. 8b, the force with the protruding part for picking is on the right side of the biosensor.

[0092] Figs. 9b and 10b show a portion having a strong adhesive layer 18 at the boundary with the portion 23 having the removable layer, which is bonded and fixed to the left end of the cover 2 of the biosensor 20 by the strong adhesive layer 18. Is perforated 17.

When the non-adhesive portion 13 is pinched and the protective film 11 is peeled laterally from the right to the left to the perforations 17, a complete fold is formed at the perforations 17. The operation at the time of measurement and after the measurement can be performed simply and reliably, as in the description of FIG. 4 and FIG.

FIG. 10b shows a case where a part of the protective film 11 of FIG. In this case, a perforation 17 can be provided instead of the cut 19, and in some cases, the cut 19 or the perforation 17 need not be provided.

[0093] Although not shown in the figure, when it is desired to provide a part that does not peel off at least a part of the protective film 11 without using the strong adhesive layer 18, if the part is the part 23 having the removable layer 12, By providing perforations 17 at the boundary of the peeled portion, that portion can be provided.

FIG. 11 shows an example of a substrate, a cover, and a sample transport path of another biosensor suitable for applying the protective film 11 of the present invention. In this example, the cover 2 is made of a transparent material so that the positional relationship among the pattern 4 including the electrodes on the substrate 1, the sample transport path 7, the sample inlet 8, the air outlet 9, and the reagent layer 10 is clear. Is shown in FIG. Other biosensors consist of a substrate 1, a cover 2, and a spacer 3 between them.

FIG. 11a shows a biosensor having two sample transport paths 7, in which one sample inlet 8 is provided at the center of the sample transport path 7 provided in one direction, and both sides of the sample transport path 7 Has a reagent layer 10 and air exhaust ports 9 at both ends. The one sample inlet 8 and the two air outlets 9 are formed on the same surface of the cover 2.

[0096] The figure lib has two sample transport paths 7 extending in two directions from one sample inlet 8, and each sample transport path 7 has a reagent layer 10 and an air exhaust port 9 formed therein.

[0097] Fig. 11c shows that four sample transport paths 7 are provided in four directions from one sample inlet 8, and each sample transport path 7 has a reagent layer 10 and an air exhaust port with the sample inlet 8 interposed therebetween. 9 are each formed.

[0098] In these biosensor structures, the sample solution 14 is sucked from one sample inlet 8 in many directions and is developed, so that the biocatalytic reaction and the electrochemical reaction are performed in each reagent layer. It can be monitored without being affected by the reagent layer. In addition, in all of the biosensor structures shown in FIG. 11, the sample introduction port 8 and the air exhaust port 9 are formed on the surface of the cover 2 with a force S, and the biosensor structure of the present invention is limited to such a shape. It is not something. Further, as the protective film 11, various types described above can be appropriately applied. Further, other biosensors of the present invention are not limited to those described above, and include a part of an array-shaped biosensor described later. By applying the protective film to such a biosensor, the same effect as described above can be obtained.

[0099] Fig. 12 to Fig. 14 show an example of a form in which the protective film 11 packages an array of biosensors.

[0100] Fig. 12a shows a development view of an array of biosensors. This biosensor in the form of an array comprises a substrate 1, a cover 2, and a spacer 3 between them. A pattern 4 including a plurality of electrodes and terminals 5 are formed on the surface of the substrate 1. The electrodes 25 in the pattern 4 including the plurality of electrodes are arranged in parallel so that each of them is orthogonal to the reagent transport path 7. A reagent layer 10 can be provided on each of the electrodes 25 as needed. [0101] As the spacer 3, either one having an adhesive layer and an adhesive applied to both sides of the spacer material can be used. In addition to the role of bonding and fixing the substrate 1 and the cover 2, the sample transporter can be used. It has a role in defining Road 7. Therefore, a spacer-free portion 6 is provided in a part of the spacer except for a central portion serving as a sample transfer path 7. At both ends of the sample transfer path 7, there are formed through holes 15 corresponding to a sample inlet 8 for injecting the sample liquid 14 and an air outlet 9 for exhausting air in the sample transfer path 7. .

Here, although not shown in FIG. 12, the sample inlet 8 and the air outlet 9 of the biosensor are not formed on the cover 2 but on the back side of the substrate 1 by the same preparation method. They are formed.

[0103] FIG. 12b shows a structural diagram of an array of biosensors. In the biosensor, as shown in Fig. 12a, 10 pairs of electrodes 25 and a reagent layer 10 are provided in the sample transport path 7, and for example, DNA having a different base sequence is immobilized on each reagent layer. By doing so, it can be used to detect multiple DNA sequences, including single nucleotide polymorphisms (SNPs). This type of biosensor is capable of taking a fixed amount of the sample liquid into the sample transport path 7, so that it has reproducibility of measurement and is not easily affected by evaporation and drying when measuring a small amount of sample liquid. You.

FIG. 12c shows an example of the biosensor 20 of the present invention. In the example of FIG. 12, since the sample introduction port 8 and the air exhaust port 9 are formed on the same surface of the cover 2 of the biosensor 20, the packaging with the protective film 11 can be performed easily and reliably.

FIG. 13 and FIG. 14 show another example of the array-like biosensor as in FIG. 12. The array-like biosensor of FIG. 13 has one array as shown in FIG. 13a_ (2). The spacer-free portion 6 corresponding to the sample transfer path 7 extends radially around the through hole 15 (8) corresponding to the sample inlet 8, and the through-hole corresponding to the air exhaust port 9 is provided at the end point. Hole 15 (9) is formed.

As shown in FIG. 13a- (1), ten sets of electrodes 25 and reagent layers 10 are formed on each sample transport path 7, and are arranged in two rows and ten columns on the substrate. . Therefore, the array-shaped biosensor shown in Fig. 13 measures a total of 200 types of measurement targets simultaneously from the same sample solution. That can be S. FIG. 13c shows a biosensor 20 of the present invention having a protective film. As described above, since the sample introduction port 8 and the air exhaust port 9 are formed on the same surface of the cover 2 of the biosensor, the packaging with the protective film 11 can be performed easily and reliably.

[0107] The array-like biosensor shown in Fig. 14 is composed of ten sample inlets 8, sample transport paths, air outlets 9, electrodes 4, and reagent layers 10 as one unit, and ten units arranged in parallel. This is an example in which two rows and ten columns are arranged on a biosensor, and a total of 200 kinds of sample liquids can be measured simultaneously.

With the array-shaped biosensor shown in Fig. 14, the volume of the sample solution can be kept constant, and a small amount of the sample solution can be evaporated on a flat substrate using a multi-channel automatic liquid separation device. It can be used as an alternative to the measurement method performed under the influence of drying. FIG. 14c shows a biosensor 20 of the present invention having a protective film. As described above, since the sample introduction port 8 and the air exhaust port 9 are formed on the same surface of the cover 2 of the biosensor, the packaging with the protective film 11 can be performed easily and reliably.

FIG. 15 shows an example in which a plurality of biosensors 20 of the present invention having a protective film adhered to an adhesive surface are regularly arranged at predetermined intervals. In the case of a connection-type biosensor arranged in this manner, simultaneous or continuous measurement can be performed by introducing a test solution from each sample inlet. The number of sensor units provided in the articulated biosensor is not particularly limited, but is preferably 20-30. The sensor units can be arranged horizontally as shown in FIG. 15, or, although not shown, the sensor units can be arranged vertically.

Further, by providing perforations or the like on the substrates of the plurality of biosensors which are regularly arranged at predetermined intervals, storage space can be saved, and bending and individual bending of connected electrodes can be achieved. Separation of the electrodes and the like can be made possible, and one of the objects of the present invention can also enable sanitary treatment after use of each electrode.

FIG. 16 shows an example of a box-shaped container capable of storing a plurality of biosensors 20 of the present invention in which a protective film is adhered to an adhesive surface. The no sensor 20 is housed in a container 21, closed in a lid 22, and housed in a box. In addition, the packaging form of the biosensor provided with the protective film of the present invention is not limited to a box-shaped container, and can be used for a bottle container method and the like. [0110] When a plurality of biosensors are housed in a box-shaped container or the like in a well-organized manner, and the biosensors are taken out in order of container force, the individual biosensors are placed on the main body or the protective film. By printing the serial number or the remaining number of biosensors in the container, the number of biosensors in the container can be ascertained.

FIG. 17 shows an example in which the number of remaining biosensors is printed on a protective film in the biosensors 20 regularly arranged at predetermined intervals.

Claims

The scope of the claims

[1] A biosensor provided with a sample inlet and an air outlet communicating with the sample inlet, and an adhesive surface capable of blocking the sample inlet and the air outlet from the outside of the biosensor. A biosensor comprising a protective film capable of bonding and peeling off.

[2] including an insulating substrate, an insulating cover bonded to the substrate via a bonding layer, a protective film, and an electrode formed on the substrate in a space between the substrate and the cover,

In the space between the substrate and the cover, there is provided a sample transport path extending from the sample inlet to the air outlet through the electrode,

The protective film has a size capable of sealing at least the sample inlet and the air outlet, and is a detachable layer that can be bonded to and peeled from an adhesive surface where the sample inlet and the air outlet are present. A biosensor comprising:

3. The biosensor according to claim 2, wherein the sample inlet and the air outlet are formed on the same surface.

[4] The sample inlet and the air outlet are formed on a surface of the substrate, or the sample inlet and the air outlet are formed on a surface of the cover. Or the biosensor according to 3.

5. The biosensor according to claim 2, wherein the adhesion surface is a substrate surface or a cover surface.

[6] The biosensor according to any one of [25] to [25], wherein a reagent layer is present on at least an electrode in a region through which the sample transport path passes.

[7] The biosensor according to claim 26, wherein the electrodes form an array.

[8] The biosensor according to any one of claims 2 to 7, wherein a desiccant and / or a deoxidizer exists in a space between the substrate and the cover.

[9] The biosensor according to claim 8, wherein the sample transport path and the desiccant and / or the oxygen scavenger are separated by a separator.

[10] The biosensor according to any one of claims 2 to 9, wherein the protective film has a portion having a removable layer and a non-adhesive portion.

[11] The biosensor according to any one of [2] to [10], wherein the protective film is bonded to the adhesive surface via a non-peeling layer that does not peel off from the adhesive surface.

12. The biosensor according to claim 211, wherein a perforation or a cut is formed in a part of the protective film for peeling the protective film.

13. The biosensor according to claim 212, wherein a perforation for bending the protective film is formed in a part of the protective film.

[14] The biosensor according to any one of [213], wherein the protective film is a plastic film.

[15] The method according to item [214], wherein the protective film on the adhesive surface side is partially or entirely coated with a deoxidizer or an oxygen impermeable material. Biosensor.

[16] The biosensor according to any one of claims 2 to 15, wherein a part or the whole of the surface of the protective film is coated with an ultraviolet absorbent or an ultraviolet non-transmissive substance.

17. The biosensor according to claim 2, wherein the substrate is made of a material that is not permeable to ultraviolet light.

[18] The biosensor according to any one of [2] to [17], wherein the surface of the substrate is coated with an ultraviolet absorbent or an ultraviolet non-transmissive substance.

[19] The biosensor according to any one of claims 2 to 18, wherein the removable layer is made of an acrylic adhesive, a silicone adhesive, or a rubber adhesive.

[20] The biosensor according to any one of claims 2 to 19, wherein the protective film is adhered to an adhesive surface.

21. The method according to claim 220, wherein a plurality of the biosensors are regularly arranged at a predetermined interval, and perforations are provided on a substrate of the connected biosensors. Biosensor.

[22] A biosensor package containing a plurality of the biosensors according to claim 2-21.

[23] A protective film for simple packaging of a biosensor provided with a sample inlet and an air outlet communicating with the sample inlet, wherein the sample inlet and the air outlet are outside the biosensor. A simple packaging protection film for biosensors that can be shut off from parts and can be adhered to and peeled off from the biosensor surface.

[24] A method for using a biosensor comprising a sample inlet and an air outlet communicating with the sample inlet, and having a protective film capable of blocking the sample inlet and the air outlet from the outside of the biosensor. hand,

At the time of using the biosensor, part or all of the protective film is peeled off from the biosensor, and after the biosensor is used, the peeled protective film is reattached to the surface of the biosensor, and the sample introduction port and the air outlet are provided. The biosensor is sealed by covering the biosensor with the protective film.

[25] The biosensor according to any one of claims 1-11, a measuring unit for measuring an electric value of an electrode of the biosensor, and a display unit for displaying a measured value in the measuring unit. A biosensor device comprising: a memory unit for storing the measurement value.