JP2005069952A - Biosensor having adhesive and separable protective film - Google Patents

Abstract

<P>PROBLEM TO BE SOLVED: To provide a biosensor, where an airtight packaging method for shielding the inside of the biosensor easily and reliably from the outside world before and after use, without requiring thermocompression bonding, is applied. <P>SOLUTION: The biosensor comprises a sample inlet and an air outlet for communicating with the sample inlet, and the biosensor has a protective film that can be adhered to and separated from an adhesion surface that can shield the sample inlet and the air outlet from the outside of the biosensor. <P>COPYRIGHT: (C)2005,JPO&NCIPI

Description

The present invention relates to a biosensor. More specifically, the present invention relates to a biosensor having a protective film that can be bonded and peeled off.
The present invention also relates to a simple packaging protective film for a biosensor. More specifically, the present invention relates to a simple packaging protective film for a biosensor that can be bonded to and peeled from the adhesive surface of the biosensor.
The present invention further relates to a method of using a biosensor and a biosensor device.

  In the conventional disposable sensor packaging form, as a method of using a container, a method of storing a plurality of biosensors in a bottle container, storing one biosensor in one container one by one, and opening the container entrance There is a method of thermocompression bonding with a film (Patent Document 1). In these systems, it is possible to keep a dry state by putting a desiccant or the like in the container.

  However, in the case of the former method, the number of times of opening and closing increases each time it is used, and the dehumidifying ability of the desiccant decreases due to moisture at the time of opening. Such a packaging form is not suitable for use under humid climatic conditions as in Japan. Further, in order to keep the storage state of the biosensor in good condition, it is necessary to block ultraviolet rays and oxygen, but such measures are not taken.

  In the case of the latter method, since biosensors are stored one by one in the container, a large amount of materials must be used for packaging. From the viewpoints of effective use of limited resources and waste disposal, It is not a friendly packaging form.

  A method has been attempted in which a biosensor is sandwiched with a desiccant between two films coated with an ultraviolet absorber or an ultraviolet opaque material on the surface and bonded by thermocompression bonding from the outside of the film. Patent Document 2).

  However, in this method, heat is applied at the time of packaging. Therefore, there is a risk of deformation of the biosensor main body, deterioration of the chemical substance developed in the reagent layer, and denaturation of the biomaterial due to the heat during processing and the accompanying thermal oxidation. In addition, in order to maintain a certain wet state, it is necessary to consider the influence of heat vapor pressure. Moreover, since the film used for packaging permeates oxygen, the effect cannot be expected for packaging under a nitrogen atmosphere, and there is an influence of air oxidation during the storage period due to packaging in air. Furthermore, in a package formed by thermocompression bonding, the bonding portion is strongly bonded with two films, so that it cannot be easily opened. For this reason, when a person with a physical disability, an elderly person, a low-aged person, etc. open such a package, it is anticipated that difficulty will be forced depending on the case.

  Furthermore, in this packaging form, after a sample that may be infected is measured with a biosensor, the biosensor is returned to the original package after being opened and disposed of again before being discarded. There is a problem that the biosensor comes out of the package and the sample attached to the outside of the biosensor may adhere to the outside, which may cause infection.

JP 2000-314711 GUNZE CO., LTD. Sensor packaging and method of using the same JP2003-72861A / Matsushita Electric Industrial Co., Ltd./Biosensor packaging method

In the conventional method, first, the bottle container method has a problem that the internal dry state cannot be maintained by repeated opening and closing. In addition, in the method of packaging a single biosensor in a container, there is a problem that the process is complicated and a lot of materials are required because a container that is bulky with respect to the size of the biosensor is used. Furthermore, in the method of packaging a single biosensor by thermocompression bonding with two films, it is impossible to eliminate the effects of heat and oxidation even if UV rays are blocked and the dry state can be maintained by using a desiccant. In addition, there is a problem in the disposal method of the biosensor after using the operability and infectious sample when 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 block the inside of the biosensor from the outside before and after use. This is the issue.

The present invention has been made in view of the above problems, and the inventors of the present invention cover and seal the sample inlet and the air outlet of the biosensor with a protective film having a removable layer that can be bonded and peeled off. Therefore, excellent sealing performance can be easily obtained before using the biosensor, the influence of heat in the biosensor packaging process can be eliminated, and the sample introduction port and the air discharge port can be easily used even after using the biosensor. Thus, the present invention was completed by finding that infection depending on the specimen sample can be effectively prevented.
That is, the present invention includes the following.

  [1] A biosensor comprising a sample introduction port and an air discharge port communicating with the sample introduction port, wherein the sample introduction port and the air discharge port can be blocked from the outside of the biosensor; A biosensor comprising a protective film capable of adhering and peeling.

  [2] including an insulating substrate, an insulating cover bonded to the substrate through a bonding layer, a protective film, and an electrode formed on the substrate in a space sandwiched 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 seals at least the sample inlet and the air outlet. A biosensor having a detachable layer having a size that can be bonded to and peeled from an adhesive surface where the sample inlet and the air outlet are present.

  Thus, by sealing the sample inlet and the air outlet of the biosensor with a protective film that can be bonded and peeled off, excellent sealing properties can be easily obtained before using the biosensor. For this reason, for example, the reaction layer can be stored for a long period of time, and the inside of the biosensor can be controlled to a desired constant humidity.

  In addition, since the protective film is simply adhered to the adhesive surface by the removable layer, it is possible to eliminate the influence of heat during the production of the biosensor without using heat in the production process.

  Further, even after the biosensor is used, it can be easily sealed again with the protective film from which the sample introduction port and the air discharge port are peeled off, so that the specimen sample can be prevented from flowing out.

The sample introduction port may be formed at one end of the sample conveyance path or at an intermediate point as long as the sample can be injected into the sample conveyance 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 sides of the spacer. Therefore, the bonding layer adheres the substrate and the cover and defines the sample transport path.
The electrode means a set of electrodes in which a + electrode and a − 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, it is preferable that the sample inlet and the air outlet are formed on the same surface.

  In such an embodiment, without using a packaging method involving heat such as thermocompression bonding, the sample introduction port and the air discharge port are bonded to the sample introduction port and the air discharge port under normal temperature and normal pressure conditions. The air outlet can be simply, uniformly and reliably sealed, and the internal airtightness can be kept high.

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

  As the opening direction of the sample introduction port and the air discharge port, for example, both may be opened in a direction perpendicular to the bonding surface (in this case, all of the sample introduction port and the air discharge port exist on the same surface). For example, the sample inlet may be opened in a direction perpendicular to the bonding surface, and the air outlet may be opened in the direction of the adhesive surface (in this case, all or part of the sample inlet and the air outlet may be the same). Present on the surface).

  In the present invention, in addition to the sample introduction port and the air discharge port, sensor main parts existing on the same surface, for example, terminals and connection parts of measuring instruments can be covered with a protective film.

[4] It is preferable that the sample inlet and the air outlet are formed on the surface of the substrate, or the sample inlet and the air outlet are formed on the surface of the cover.
[5] Furthermore, the adhesive surface is preferably a substrate surface or a cover surface.

  Thus, the sample introduction port and the air discharge port only have to be simultaneously present on any plane of the substrate surface or the cover surface. That is, the adhesion surface where the sample introduction port and the air discharge port exist can be a substrate or a cover surface.

[6] It is preferable that a reagent layer exists on at least the electrode in the region through which the sample transport path passes. According to the present invention, the sample and the sample react with each other when the sample fed from the sample transport path comes into contact with 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 set of electrodes in which the + electrode and the − electrode face each other, and such an electrode may be composed of two electrodes including + and −, or two or more electrodes. It may be. The reagent layer is preferably present on one or both of the + electrode and the − electrode.

  In the present invention, the periphery of the sample inlet and the surface of the sample transport path can be coated with a surfactant and lipid. By coating the surface active agent or lipid, the sample can be moved smoothly. Moreover, the tip part of the sample introduction port can have a structure having a curved part.

  [7] When the biosensor of the present invention is used as a DNA chip or the like, the electrodes may be arrayed. In this specification, “array” means an array.

  The arrayed biosensor may have at least one sample introduction port and at least one air discharge port on the same surface, and may have at least one reagent layer in the sample transport path.

Further, for example, in the array-shaped biosensor, at least two sample transport paths branch from one sample introduction port, and the sample liquid introduced from the sample introduction port is uniformly transported to each sample transport path. All reagent layers can be reached.
In order to allow the sample solution to reach all the reagent layers in the array, a surfactant is coated in the sample transport path, or when the sample solution is blood or the like, heparin or prolixin-S is used as an anticoagulant. , Ethylenediaminetetraacetic acid, metal salt of citric acid, etc. may be coated.
[8] A desiccant and / or an oxygen scavenger may be present in the space between the substrate and the cover.

Examples of the desiccant include porous structures such as silica gel, activated alumina, calcium chloride, molecular sieves, and hygroscopic polymers.
Examples of the oxygen scavenger include powders composed of metals such as iron and metal halides, hydrosulfite, activated magnesium (for example, JP 2001-037457 A), and ascorbic acid (for example, JP 05 05 A). -007772), catechol compounds (for example, JP 09-075724 A), and polyhydric alcohols (for example, JP 2003-144113 A). These oxygen scavengers may be supported on a carrier as known in the art (for example, JP 2001-037457 A). Examples of commercially available oxygen scavengers include “AGELESS” (trademark, manufactured by Mitsubishi Gas Chemical Co., Inc.), “Vitalon” (trademark, manufactured by Toagosei Co., Ltd.), and the like.

  Since the biosensor of the present invention is sealed with a protective film before use, for example, by having such a desiccant and / or oxygen scavenger in the biosensor, an internal dry state or an oxygen-free state can be obtained. Can be held for a long time.

  Further, even when the biosensor is sealed with a protective film in an atmosphere containing moisture and oxygen during packaging, the inside of the biosensor can be brought into a dry state or a deoxygenated state.

  Furthermore, the inside of the biosensor can be maintained at a constant humidity for a long period of time as required. For this reason, for example, even if the sample liquid cannot be smoothly introduced when the sample transport path of the biosensor is in a dry state, a surfactant or the like is applied to the inner wall of the sample transport path while maintaining a constant humidity. By doing so, 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.

  Similarly, since the reagent layer can maintain a constant humidity, even when oxygen is present in the atmosphere inside the biosensor, deterioration or denaturation of the reagents protected by moisture due to air oxidation can be suppressed. it can.

In the present invention, the surface of the reagent layer can be coated with a compound that facilitates movement of the sample liquid such as a surfactant and lipid. If the surface of the reagent layer is coated with a surfactant or the like, deterioration due to air oxidation can be further suppressed. When the sample solution is blood or the like, heparin, prolixin-S, ethylenediaminetetraacetic acid, a metal salt of citric acid, or the like may be coated as an anticoagulant.
In the present 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 / or oxygen scavenger are separated by a separator.

  Examples of the separation membrane include a mesh made of a polymer such as Teflon (trade name) that is hydrophobic and air permeable, a filter, and a porous membrane. With such an isolation film, it is possible to prevent the sample moving in the sample transport path and the desiccant and / or oxygen scavenger from coming into direct contact.

  [10] The protective film may have a part having a removable layer and a non-adhesive part. This non-adhesion part can be used for peeling or re-adhesion of the protective film as a knob part.

  [11] The protective film may be bonded to the adhesive surface through a non-peeling layer that does not peel from the adhesive surface. Thereby, when peeling a protective film again after peeling, positioning of a protective film can be performed simply and easily. The non-peeling layer is not particularly limited as long as the non-peeling layer has an adhesive force that does not peel in a normal use state. The non-peeling layer is preferably made of a strong adhesive such as epoxy, cyanoacrylate, or organic polysiloxane.

  [12] A protective film peeling perforation or cut may be formed in a part of the protective film. The perforation for peeling off the protective film only needs to be perforated at intervals that can be easily separated. Thereby, when peeling a part or several parts of a protective film, the protective film part can be peeled along a perforation or a cut.

  [13] A protective film folding perforation may be formed on a part of the protective film. When such a perforation exists, a crease is easily attached along the perforation when the protective film is peeled off without providing a non-peeling layer, that is, without fixing a non-isolated portion with a strong adhesive. be able to. For this reason, handling of the biosensor at the time of measurement becomes easy, and the protective film can be easily adhered again after use. The perforations are not particularly limited in size, shape, etc., as long as the perforations can be easily bent and spaced.

  [14] The protective film is preferably a plastic film. Of the plastic films, polyvinylidene chloride, polyester, nylon, ethylene-vinyl alcohol copolymer, fluorine resin, and the like are preferable. Such plastic has flexibility and excellent moisture barrier. Furthermore, the protective film may be a single layer or a multilayer structure.

  [15] A part or all of the surface of the protective film on the adhesive surface side may be coated with an oxygen scavenger or an oxygen-impermeable material. Oxygen permeation can be suppressed or blocked by coating with such an oxygen scavenger or oxygen non-permeating substance. In order to avoid contact between the oxygen scavenger or the oxygen-impermeable substance and the outside, it is preferable that these are formed on the adhesive 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 silicon oxide thin film, a metal thin film such as aluminum, polyvinylidene chloride, polyester, nylon, an ethylene-vinyl alcohol copolymer, and a fluorine resin. The vapor deposition of silicon oxide can be performed by a known method (Japanese Patent Laid-Open No. 7-190984).

[16] A part or all of the surface of the protective film may be coated with a UV absorber or a UV opaque material. When coated with such an ultraviolet absorber or ultraviolet non-transparent substance, the transmission of ultraviolet rays can be suppressed or blocked.
Although it does not specifically limit as a ultraviolet absorber, For example, organic compounds, such as metals, such as aluminum, metal halides, such as silver chloride, a benzotriazole type, etc. are mentioned.
Although it does not specifically limit as an ultraviolet-ray impermeable substance, For example, vapor deposition films, such as metal halides, such as metals, such as aluminum, or a silver chloride, Organic compound type films, such as a benzotriazole type, etc. are mentioned.

  [17] The substrate is not particularly limited as long as it is electrically insulating, but plastic, biodegradable material, paper, and the like can be employed. A suitable example of plastic is polyethylene terephthalate. The substrate may be made of an ultraviolet non-transparent material.

  [18] Furthermore, the substrate surface may be coated with an ultraviolet absorber or an ultraviolet opaque material.

  In the present invention, the cover may be made of the same material as the substrate as shown in the above [16], and the surface may be coated with a substance as shown in the above [17]. .

  Among the materials of the bonding layer, the spacer can be the same material as the substrate as shown in [16], and the surface is coated with a substance as shown in [17]. May be.

  In the present invention, it is preferable that the substrate, the cover and the spacer are coated with the ultraviolet absorber or the ultraviolet non-transparent material, or the substrate, the cover and the spacer are made of the ultraviolet non-transparent material.

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

As the acrylic pressure-sensitive adhesive, for example, a pressure-sensitive adhesive mainly composed of acrylic acid esters such as methyl acrylate and ethyl acrylate is preferable.
As the silicone pressure-sensitive adhesive, a pressure-sensitive adhesive mainly composed of dimethylpolysiloxane or the like is preferable.

Acrylic adhesives and silicone adhesives can be provided that are stable against ultraviolet rays, oxygen, and chemicals, and can be easily synthesized in a uniform manner according to the purpose.
[20] The protective film may be adhered to the adhesive surface. The case where the protective film is adhered to the adhesive surface includes before and after use of the biosensor according to the present invention.

The electrode can be composed of any one of carbon, silver, silver / silver chloride, platinum, gold, nickel, copper, palladium, titanium, iridium, lead, tin oxide, and platinum black. Carbon may be carbon nanotubes, carbon microcoils, carbon nanohorns, fullerenes, dendrimers, or derivatives thereof.
Such an electrode can be formed on the substrate or the cover by any of screen printing, vapor deposition, sputtering, foil sticking, and plating.

  The adhesive layer that can be the bonding layer can also be formed by a screen printing method. Moreover, you may contain reagents, such as an enzyme, a mediator, and surfactant, in this adhesive bond layer.

The reagent layer includes an enzyme, an antibody, a nucleic acid, a primer, a peptide nucleic acid, a nucleic acid probe, a microorganism, an organelle, a receptor, a cell tissue, a molecular identifier such as a crown ether, a mediator, an insertion agent, a coenzyme, an antibody labeling substance, a substrate, Any one or a combination of inorganic salts, surfactants and lipids or a combination thereof can be appropriately contained depending on the test object by the biosensor.
When the sample solution is blood or the like, an anticoagulant may be included. Examples of the anticoagulant include heparin, prolixin-S, ethylenediaminetetraacetic acid, and a metal salt of citric acid.

Examples of the enzyme include enzymes such as oxidase or dehydrogenase, such as glucose oxidase, fructosylamine oxidase, lactate oxidase, urate oxidase, cholesterol oxidase, alcohol oxidase, glutamate oxidase, pyruvate oxidase, glucose dehydrogenase, lactate dehydrogenase, alcohol dehydrogenase, cholesterol Esterase, protease, pyruvate oxidase, peroxidase, glucose dehydrogenase, lactate dehydrogenase, alcohol dehydrogenase, and other nucleic acid-linked enzymes such as cholesterol esterase, inorgano pyrophosphatase, maltose phosphorylase, mutarotase, catalase, protease, DNase , Like restriction enzyme such as DNA ligase.
These can be used alone or in combination.

  Further, the reagent layer may be contained not as an enzyme alone but as a combination of mediators. This mediator is selected from potassium ferricyanide, ferrocene, and benzoquinone. The reagent layer may contain a combination of inorganic salts such as sodium chloride and potassium chloride and quinhydrone.

  The reagent layer may contain a combination of primer, DNA polymerase, and deoxyribonucleotide triphosphate. Further, the reagent layer may contain a combination of inorganic salts such as sodium chloride and potassium chloride and quinhydrone in primer, DNA polymerase, deoxyribonucleotide triphosphate.

  When using a biosensor as a DNA chip, a nucleic acid probe can be immobilized as a reagent layer. In this case, it is preferable to arrange the electrodes in an array.

  The reagent layer is formed by a screen printing method or a dispenser method, and the immobilization of the reagent layer on the electrode surface or the substrate surface can be performed by an adsorption method or a covalent bonding method with drying.

  Such a reagent layer is not limited to one place, and two or more places can be provided. In that case, two or more kinds of different reagent layers may be provided. Further, when two or more reagent layers are provided, a convex partition portion can be provided between them. The convex partition portion can be formed by a screen printing method. The partition part of this convex part can be comprised from either carbon, a resist, or a water absorbing material.

[21] A plurality of the biosensors may be regularly arranged at predetermined intervals, and perforations may be provided on the connected biosensor substrates.
With this configuration, a large number of biosensors can be efficiently manufactured at one time. Further, by connecting each individual biosensor (sensor unit) of the connected biosensors to the measurement unit, it is possible to provide a measurement apparatus that can measure a large number of specimens simultaneously. Further, in this configuration, since the plurality of sensor units are regularly arranged at a predetermined interval, the individual sensor units can be rotated and moved sequentially to be connected to the measuring instrument. With this type of measuring apparatus, it is possible to continuously and automatically measure a large number of specimens. Further, by providing perforations or the like on the connected electrode sheets (substrates), it is possible to reduce the storage space, bend between the connected biosensors, and separate individual electrodes.

[22] A biosensor package according to the present invention contains a plurality of the biosensors.
More specifically, a plurality of the simply packaged biosensors of the present invention can be packaged together by a bottle container method or a box container method.

  Further, the plurality of biosensors of the present invention can be accommodated in a state in which they are arranged in a container by a box-type container method or the like, and when the biosensor is sequentially removed from the container, the main body or the protective film is individually The biosensor serial number or the remaining number of biosensors in the container can be printed.

  [23] A simple packaging protective film for a biosensor according to the present invention is a protective film for simple packaging of a biosensor comprising a sample introduction port and an air discharge port communicating with the sample introduction port. The mouth and the air discharge port can be shielded from the outside of the biosensor, and can be bonded and peeled off from the biosensor surface. Such a protective film can be preferably used for the biosensor according to the embodiments described in [2] to [21].

[24] The method of using the biosensor of the present invention includes a sample introduction port and an air discharge port communicating with the sample introduction port, and protection that can block the sample introduction port and the air discharge port from the outside of the biosensor. A method of using a biosensor having a film,
A part or all of the protective film is peeled off from the biosensor when the biosensor is used, and the protective film peeled off after the use of the biosensor is adhered again to the biosensor surface, and the sample introduction port and the air discharge port are opened. It is characterized by being covered and sealed with the protective film.
In such a biosensor usage method, the biosensor according to the embodiments described in [2] to [21] can be preferably used.

[25] The biosensor device of the present invention includes the biosensor according to any one of [1] to [21],
A measurement unit for measuring an electrical value in the electrode of the biosensor;
A display unit for displaying a measurement value in the measurement unit;
And a memory unit for storing the measured values.
Any of potential step chronoamperometry, coulometry, and cyclic voltammetry is used as a measurement method in the measurement unit. Furthermore, Bluetooth can be mounted on the apparatus as a wireless means.

  The biosensor of the present invention does not need to be manufactured by a method such as thermocompression bonding, is easy to manufacture, and can improve yield. Moreover, it has excellent sealing properties, can eliminate the influence of oxidation of the reagent layer in the biosensor, and has excellent long-term storage stability. In addition, since the protective film can be easily adhered and peeled off, it is extremely excellent in operability even for users who are handicapped by the body, and it is extremely hygienic because the biosensor can be easily sealed after use. . When the configuration, material, series of manufacturing methods, and the like are evaluated, the biosensor of the present invention can significantly reduce the environmental burden during manufacturing and after use as compared to conventional disposable biosensors.

EXAMPLES Hereinafter, although this invention is demonstrated using an Example, this invention is not limited to a present Example at all.
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. 1a shows a typical biosensor substrate 1 and a pattern 4 and a reagent layer 10 comprising electrodes on the substrate. The pattern 4 including the electrodes is bent in an L shape at the lower end of the drawing, and this L-shaped portion is orthogonal to a reagent transport path 7 described later. Moreover, the reagent layer 10 can be provided in the L-shaped part of the pattern 4 containing this electrode as needed.
FIG. 1 b shows an example of a side surface where the cover 2 is 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 transport path 7 is formed.
As the spacer 3, a spacer material having an adhesive layer on both surfaces can be used. As the bonding layer, an adhesive layer can be used in addition to the spacer. The bonding layer formed by the spacer 3 has a role of defining the sample transport path 7 in addition to the role of bonding and fixing the substrate 1 and the cover 2 together.
In addition, a sample introduction port 8 for injecting the sample liquid 14 and an air exhaust port 9 for exhausting the air in the sample conveyance path 7 are formed at both ends of the sample conveyance path 7. The through holes 15 corresponding to the air outlet 8 and the air outlet 9 are provided at both ends of the space 6 of the spacer.
FIG. 1c is a view in which a cover 2 is coupled to the substrate 1 of FIG. 1a. 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. 1c, the sample introduction port 8 and the air exhaust port 9 of the biosensor can be formed on the substrate 1 side in the same production method.

FIG. 1d shows a plan view of the biosensor 20 of the present invention. The cover 2 is packaged 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 attached to the surface of the biosensor cover 2 by the removable layer 12 as shown in FIG. Can be packaged in a simple and uniform state.
For this reason, the inside of a biosensor will be in the state completely isolate | separated from the external atmosphere, and airtightness can be maintained. Moreover, the non-adhesive part 13 in the protective film 11 can cover the terminal part 5, and can also be used as a knob part when the protective film 11 is peeled off.

  FIG. 1e shows an example of use for testing a biosensor. The non-adhesive part 13 of the protective film 11 can be picked from this biosensor, and the part 23 having the removable layer 12 can be peeled off. The biosensor from which the protective film 11 has been peeled in the vertical direction brings the sample liquid 14 as a measurement object into contact with the sample introduction port 8 and sucks up the sample liquid 14. The sucked sample liquid 14 contacts the reagent layer 10 shown in FIG. 1a when passing through the sample transport path 7 shown in FIG. 1g, and the reagent layer 10 reacts with the target component in the sample liquid 14 and reacts. Electrochemical changes such as the generated potential and current are detected by the electrodes. When the reagent layer 10 is not present, the target component is detected only by the electrode.

  FIG. 1f shows an example after use of the biosensor. The biosensor after use for inspection or the like is the protective film 11 packaged before using the biosensor so that the sample introduction port 8 and the air exhaust port 9 on the same plane of the cover 2 are closed. By re-applying, a sample solution that may be infected, such as blood, can be kept inside the biosensor in a state of being cut off from the outside after being used for testing. The sample solution used in this case is not limited to an infectious sample solution, but includes other chemically or physiologically dangerous sample solutions. The biosensor after use repackaged in this way can eliminate the risk of infection and contact with dangerous substances by eliminating leakage of the sample liquid.

  FIG. 1g is an example of an AA cross-sectional enlarged view of FIG. 1d. A pattern 4 including an electrode and a spacer 3 are formed on the surface of the substrate 1, and a cover 2 is bonded via the spacer. A sample conveyance path 7 is formed by the spacer 3. Further, an air discharge port 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 a mode in which the sample introduction port 8 is formed in the cover surface so as to open perpendicularly to the cover surface, and the air discharge port 9 is opened in the cover surface direction at the end of the cover.

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

  FIG. 2 b shows an example of the surface of the cover 2 on the side that is coupled 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 transport path 7 shown in FIG. 2g is provided. Further, a through hole 15 corresponding to the sample introduction port 8 is provided. The air discharge port 9 is formed at the end of the spacer space 6 opposite to the through hole 15.

  FIG. 2 c is a view in which the cover 2 is coupled to the substrate 1 of FIG. A terminal 5 which is a part of a pattern including electrodes remains on the surface of the substrate 1. A sample introduction port 8 is provided on the surface of the cover 2, and an air discharge port 9 opened in the cover surface direction is formed at the end of the cover of the sample transport 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 a portion 23 having the removable layer 12.
In order to seal the air discharge port 9 in this case, the removable layer 12 is thickened or a step between the substrate 1 and the cover 2 that is not the air discharge port 9 is filled with putty or a removable adhesive. Thus, the airtightness during packaging can be more reliably maintained.

  As a result, the portion 23 having the removable layer 12 adheres to the entire cover 2 and a portion of the substrate 1 where the electrode terminals 5 are exposed, and the non-adhesive layer 13 is the other biomaterial where the electrode terminals 5 are exposed. The end portion of the sensor can be covered. By doing in this way, the non-adhesion layer 13 can be used as a knob | pick part when peeling the protective film 11 from a biosensor to a 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 in 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 bonded via the spacer. A sample conveyance path 7 is formed by the spacer 3. A protective film 11 is adhered on the cover 2 by a removable layer 12.

  FIG. 3 shows an example in which the desiccant 16 is built in the biosensor 20 of the present invention, and the biosensor is packaged by the simple packaging protective film 11.

FIG. 3a shows a development view of the biosensor. 3a- (1) shows the substrate 1, and FIG. 3a- (2) shows the cover 2 and the spacer 3. FIG.
There are two through holes 15 on the cover 2 in FIG. 3a- (2), and these are the substrate 1 in FIG. 3a- (1) and the cover 2 and spacer 3 in FIG. 3a- (2) bonded together. At this time, the sample introduction port 8 and the air exhaust port 9 are formed.
3a- (2) -i is an example in which the desiccant 16 is disposed on the cover 2 across the air outlet 9 of the sample transport path 7, and FIGS. 3a- (2) -ii are examples of the desiccant 16. 3a- (2), in which the spacer is disposed on the spacer 3 with the through-hole 15 corresponding to the air outlet 9 of the spacer empty portion 6 (corresponding to the sample transport path 7) sandwiched between the spacer 3 and the spacer empty portion 6. ) -Iii shows an example in which the desiccant 16 is disposed inside the spacer 3 and around the entire space 6 of the spacer.

The biosensor shown in FIG. 3b is formed by bonding the substrate 1 with the desiccant 16 arrangement pattern of FIGS. 3a- (2) -i to iii on the cover 2. FIG.
Here, the biosensor incorporating the desiccant 16 is not limited to the shape shown in FIG. 3, and the sample introduction port 8 is formed in the cover surface so as to open perpendicularly to the cover surface, and the air discharge port 9 is formed at the end of the cover. The present invention can be applied to a biosensor having an opening in a direction, an array-shaped biosensor, or the like, and is not limited to the biosensor shown in FIG.
Furthermore, although FIG. 3 shows the case of only the desiccant 16, it is not limited to only the desiccant, and an oxygen scavenger or a oxygen scavenger and a desiccant can be used in combination instead of the desiccant.

FIG. 3c shows an example of the biosensor 20 of the present invention. In this case, the protective film 11 is packaged so as to cover the entire upper surface of the cover 2 of the biosensor 20, but is not limited to this packaging form, and can be applied to various packaging forms such as FIGS. it can.
According to this packaging method, the inside of the biosensor can be kept dry or oxygen-free for a long time. In order to maintain an oxygen-free state, a film that can be used as the protective film 11 is formed by depositing a thin film of silicon oxide or a metal thin film such as aluminum on the adhesive surface side of polyvinylidene chloride or polyester. can do.

  FIG. 3d is an example of an enlarged cross-sectional view taken along the line CC in FIG. 3c. On the surface of the substrate 1, a pattern 4 including electrodes, a spacer 3, and a desiccant 16 are provided, and a cover 2 is further bonded through the spacer. A sample conveyance path 7 is formed by the spacer 3. Further, an air discharge port 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.

  FIGS. 4-10 shows the formation form of the various protective films of the biosensor 20 in this 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 as follows. It is not limited to this, For example, the form of FIG. 2 may be sufficient. Further, it can be applied to the shape of an array-shaped biosensor described later.

  4 and 8 show examples of forms in which the protective film 11 wraps the entire top surface of the biosensor 20.

4 and 5 show a case where the protective film 11 is bonded and fixed as a strong adhesive layer 18 to the lower end of the upper surface of the biosensor, and the protective film 11 is peeled from the upper end to the lower end of the biosensor when the biosensor is used.
As shown in FIGS. 4 b, c, 5 b, and c, perforations 17 are applied to the boundary line between the portion 24 having the strong adhesive layer 18 and the portion 23 having the removable layer 12 in the protective film 11. . When the protective film 11 is peeled in the vertical direction to the perforation 17, the perforation 17 forms a complete crease at that portion. As a result, as shown in FIG. 4c, the protective film 11 is warped from the biosensor surface, so that there is no fear of disturbing the sample introduction operation during measurement.
Furthermore, in FIG. 4d, since a part of the protective film 11 is fixed to the biosensor, positioning is already performed when the protective film 11 after use is restored to the original state. The two ports of the air discharge port 9 can be closed easily and reliably.
FIG. 5 shows a case where a part of the protective film 11 is partially peeled along the cut 19 in the biosensor 20 in FIG. 4. In this case, for example, a perforation 17 can be provided instead of the cut 19 as shown in FIG. 5b. In some cases, the cut 19 and the perforation 17 may not be provided.

6 and 7, the protective film 11 is bonded and fixed to the upper end of the upper surface of the cover 2 of the biosensor 20 with the portion 24 having the strong adhesive layer 18. When the biosensor is used, the protective film 11 is the lower end of the biosensor. The case where it peels from the top to the top is shown. Similar to FIGS. 4 and 5, a perforation 17 is provided at the boundary line between the portion 24 having the strong adhesive layer 18 and the portion 23 having the removable layer 12.
As shown in FIGS. 6 c and 7 c, when the protective film 11 is peeled up to the perforation 17 in the vertical direction, the perforation 17 forms a complete crease. About the operation at the time of a measurement and after a measurement, it can carry out easily and reliably like description of FIG. 4 and FIG. FIG. 7 shows a case where a part of the protective film 11 of FIG. 6 is partially peeled along the cut 19. In this case, the perforation 17 can be provided instead of the cut 19, and the cut 19 and the perforation 17 may not be provided depending on circumstances.

8 to 10 show a case where the protective film 11 packaged on the upper surface of the biosensor 20 is peeled laterally with respect to the biosensor.
FIG. 8 b shows a form in which the protective film 11 is packaged so as to protrude from the entire upper surface and side surfaces of the biosensor 20. In this case, the entire surface of the cover 2 of the biosensor 20 is adhered by the portion 23 having the removable layer of the protective film 11, and the remaining portion protruding from the side surface of the biosensor is the non-adhesive layer 13. It can be used as a picking part. In FIG. 8b, there is a protruding portion for picking on the right side surface of the biosensor, but this may be on the left side surface.

9b and 10b show that the portion 24 having the strong adhesive layer 18 is bonded and fixed to the left end portion of the cover 2 of the biosensor 20 by the strong adhesive layer 18, and the boundary line with the portion 23 having the detachable layer is at the sewing machine line. Eyes 17 are provided.
When the protective film 11 is picked up from the non-adhesive portion 13 and peeled from the right side to the left side in the lateral direction to the perforation 17, the perforation 17 forms a complete crease. About the operation at the time of a measurement and after a measurement, it can carry out simply and reliably like description of the said FIG. 4 and FIG.
FIG. 10 b shows a case where a part of the protective film 11 of FIG. 9 b is partially peeled along the cut 19. In this case, the perforation 17 can be provided instead of the cut 19, and the cut 19 and the perforation 17 may not be provided depending on circumstances.

  Although not shown in the drawing, when it is desired to provide a portion that does not peel off at least a part of the protective film 11 without using the strong adhesive layer 18, if the portion is a portion 23 having the removable layer 12, The perforation 17 is given to a boundary line, and the part can be provided.

FIG. 11 shows an example of another biosensor substrate, cover, and sample transport path suitable for application of 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. It is illustrated as being.
Another biosensor consists of a substrate 1, a cover 2, and a spacer 3 between them.

  FIG. 11 a shows a biosensor having two sample transport paths 7. One sample introduction port 8 is provided at the center of the sample transport path 7 provided in one direction, and reagent layers are provided on both sides of the sample transport path 7. 10. Air exhaust ports 9 are present at both ends. These one sample introduction port 8 and two air exhaust ports 9 are formed on the same surface of the cover 2.

  In FIG. 11 b, there are two systems of sample transport paths 7 extending in two directions from one sample introduction port 8, and a reagent layer 10 and an air exhaust port 9 are formed in each sample transport path 7.

  In FIG. 11 c, four sample transport paths 7 are provided in four directions from one sample introduction port 8, and a reagent layer 10 and an air exhaust port 9 are formed in each sample transport path 7 with the sample introduction port 8 interposed therebetween. Has been.

  In these biosensor structures, the sample liquid 14 is sucked and expanded from one sample introduction port 8 in a number of directions, so that the biocatalytic reaction and the electrochemical reaction are influenced by the other reagent layers in each reagent layer. It is characterized by being able to monitor without receiving. Moreover, although all the structure of the biosensor shown in FIG. 11 has the sample introduction port 8 and the air exhaust port 9 formed on the surface of the cover 2, the biosensor structure of the present invention is limited to such a shape. It is not a thing. In addition, various types of the above-described protective film 11 can be appropriately applied. Furthermore, other biosensors of the present invention are not limited to those shown above, and some of the array-shaped biosensors described later are included. By applying the protective film to such a biosensor, the same effect as described above can be obtained.

  12-14 shows the example of the form which the protective film 11 packages an array-shaped biosensor.

  FIG. 12a shows a development 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 a terminal 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 as to be orthogonal to the reagent transport path 7. The reagent layer 10 can be provided on each electrode 25 as required.

  As the spacer 3, any one in which an adhesive is applied to both sides of the adhesive layer and the spacer material can be used. In addition to the role of adhering and fixing the substrate 1 and the cover 2, the spacer 3 has a role of defining the sample transport path 7. . For this reason, the spacer portion is provided with a spacer empty portion 6 excluding the central portion that becomes the sample transport path 7. Further, at both ends of the sample transport path 7, a sample introduction port 8 for injecting the sample liquid 14 and a through hole 15 corresponding to the air exhaust port 9 for exhausting air in the sample transport path 7 are formed.

  Here, although not shown in FIG. 12, the sample introduction port 8 and the air exhaust port 9 of the biosensor can be formed not on the cover 2 but on the back side of the substrate 1 by a similar production method. .

  FIG. 12b shows a structural diagram of an array of biosensors. In the biosensor, as shown in FIG. 12a, 10 sets of electrodes 25 and reagent layers 10 are provided in the sample transport path 7. For example, DNAs having different base sequences are immobilized on each reagent layer. Thus, it can be used for detection of a plurality of DNA sequences including single nucleotide polymorphisms (SNPs). Since the biosensor of this form can take a certain amount of measurement sample solution into the sample transport path 7, it has a reproducibility of measurement and is not easily affected by evaporation and drying when measuring a small amount of sample solution. .

  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, packaging with the protective film 11 can be performed easily and reliably.

FIG. 13 and FIG. 14 show another example of an array-like biosensor as in FIG.
As shown in FIG. 13a- (2), the array-shaped biosensor of FIG. 13 has a spacer empty portion corresponding to the sample transport path 7 around the through hole 15 (8) corresponding to one sample introduction port 8. 6 extends radially, and through holes 15 (9) corresponding to the air exhaust ports 9 are formed at the end points thereof.

  On each sample transport path 7, as shown in FIGS. 13a- (1), 10 sets of electrodes 25 and reagent layers 10 are formed, respectively, and arranged in 2 rows and 10 columns on the substrate. Therefore, the array-shaped biosensor shown in FIG. 13 can simultaneously measure a total of 200 types of measurement targets from the same sample solution. FIG. 13c also shows the biosensor 20 of the present invention having a protective film. Thus, 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, packaging with the protective film 11 can be performed easily and reliably.

In the array-shaped biosensor of FIG. 14, the sample introduction port 8, the sample transport path, the air exhaust port 9, the electrode 4, and the reagent layer 10 are formed as one unit, and 10 pieces are arranged in parallel on the biosensor. In this example, a total of 200 types 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 trace amount of the sample solution can be evaporated on a flat substrate using a multi-channel automatic liquid separator. In addition, it can be used as an alternative to a measurement method performed while being affected by drying. FIG. 14c also shows the biosensor 20 of the present invention having a protective film.
Thus, 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, 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 bonded to an adhesive surface are regularly arranged at a predetermined interval. With the articulated biosensor arranged in this way, simultaneous or continuous measurement is possible by introducing the test solution from each sample inlet. The number of sensor units disposed in the articulated biosensor is not particularly limited, but is preferably 20-30. As shown in FIG. 15, the sensor units can be arranged horizontally, or although not shown in the figure, the sensor units can be arranged vertically.
Further, by providing perforations or the like on the plurality of biosensor substrates regularly arranged at predetermined intervals, it is possible to save storage space, to bend between connected electrodes, and to connect individual electrodes. Separation and the like are possible, and sanitary treatment after use of the individual electrodes, which is also an object of the present invention, can be made possible.

  FIG. 16 shows an example of a box-shaped container that can store a plurality of biosensors 20 of the present invention in which a protective film is bonded to an adhesive surface. The biosensor 20 is stored in a container 21 and is stored in a box with the lid 22 closed. In addition, the packaging form of the biosensor provided with the protective film of the present invention is not limited to a box-type container, and can be used for a bottle container system.

  When a plurality of biosensors are arranged in a box-shaped container or the like and the biosensors are sequentially removed from the container, the serial numbers of the individual biosensors or the bios in the container are placed on the main body or the protective film. By printing the number of remaining sensors, the number of biosensors in the container can be grasped.

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

A representative example of the packaging of the protective film on the biosensor of the present embodiment (a structure in which the opening directions of the sample introduction port and the air discharge port are formed on the same surface in the same direction) is shown. 1a is an example of a bonding surface side of a substrate having a wiring pattern on the substrate, FIG. 1b is an example of a bonding surface side of a cover having a spacer, and FIG. 1c is a plan view of a biosensor in which the substrate and the cover are bonded together. FIG. 1d shows an example of a biosensor with a protective film adhered, FIG. 1e shows an example of use, and FIG. 1f shows an example after use. FIG. 1g shows an example of an AA cross-sectional enlarged view of FIG. 1d. Example of protective film packaging on the biosensor of the present embodiment (structure in which the opening direction of the sample introduction port is perpendicular to the cover surface and the opening direction of the air discharge port is formed on the same surface in the cover surface direction) Show. 2a is an example of a bonding surface side of a substrate having a wiring pattern on the substrate, FIG. 2b is an example of a bonding surface side of a cover having a spacer, and FIG. 2c is a plan view of a biosensor in which the substrate and the cover are bonded together. FIG. 2d shows an example of a biosensor with a protective film adhered, FIG. 2e shows an example of use, and FIG. 2f shows an example after use. FIG. 2g shows an example of the BB cross-sectional enlarged view of FIG. 2d. An example of packaging of a protective film on the biosensor of the present embodiment (a structure in which the opening directions of the sample introduction port and the air discharge port are formed on the same surface in the same direction) is shown. 3a is an example of a development view of a biosensor, FIG. 3a- (1) is an example of a bonding surface side of a substrate having a wiring pattern on the substrate, and FIG. 3a- (2) is an attachment of a cover having a spacer. This is an example of the mating surface side, i is placed on the opposite side with the desiccant sandwiching the air outlet of the sample transport path, ii is the desiccant on the opposite side of the sample transport path and the sample transport path An example of the pattern in which the desiccant is arranged in the spacer and iii is arranged in the entire periphery of the sample conveyance path inside the spacer. 3b is an example of a plan view of a biosensor in which a substrate and a cover are bonded together, FIG. 3c is an example of a biosensor in which a protective film is further adhered, and FIG. 3d is an example of an enlarged cross-sectional view of CC in FIG. An example of packaging of a protective film on the biosensor of the present embodiment (a structure in which the opening directions of the sample introduction port and the air discharge port are formed on the same surface in the same direction) is shown. 4a shows an example of a configuration diagram of a biosensor, FIG. 4b shows an example of a biosensor with a protective film adhered, FIG. 4c shows an example of use, and FIG. 4d shows an example after use. An example of packaging of a protective film on the biosensor of the present embodiment (a structure in which the opening directions of the sample introduction port and the air discharge port are formed on the same surface in the same direction) is shown. 5a is an example of a configuration diagram of a biosensor, FIG. 5b is an example of a biosensor with a protective film adhered, FIG. 5c is an example of use, and FIG. 5d is an example after use. An example of packaging of a protective film on the biosensor of the present embodiment (a structure in which the opening directions of the sample introduction port and the air discharge port are formed on the same surface in the same direction) is shown. 6a is an example of a configuration diagram of a biosensor, FIG. 6b is an example of a biosensor with a protective film adhered, FIG. 6c is an example of use, and FIG. 6d is an example after use. An example of packaging of a protective film on the biosensor of the present embodiment (a structure in which the opening directions of the sample introduction port and the air discharge port are formed on the same surface in the same direction) is shown. Fig. 7a shows an example of a configuration diagram of a biosensor, Fig. 7b shows an example of a biosensor with a protective film adhered, Fig. 7c shows an example of use, and Fig. 7d shows an example after use. An example of packaging of a protective film on the biosensor of the present embodiment (a structure in which the opening directions of the sample introduction port and the air discharge port are formed on the same surface in the same direction) is shown. 8a is an example of a configuration diagram of a biosensor, FIG. 8b is an example of a biosensor with a protective film adhered, FIG. 8c is an example of use, and FIG. 8d is an example after use. An example of packaging of a protective film on the biosensor of the present embodiment (a structure in which the opening directions of the sample introduction port and the air discharge port are formed on the same surface in the same direction) is shown. 9a is an example of a configuration diagram of a biosensor, FIG. 9b is an example of a biosensor with a protective film adhered, FIG. 9c is an example of use, and FIG. 9d is an example after use. An example of packaging of a protective film on the biosensor of the present embodiment (a structure in which the opening directions of the sample introduction port and the air discharge port are formed on the same surface in the same direction) is shown. 10a is an example of a configuration diagram of a biosensor, FIG. 10b is an example of a biosensor with a protective film attached, FIG. 10c is an example of use, and FIG. 10d is an example after use. An example of another biosensor of this embodiment (a structure in which the opening directions of the sample introduction port and the air discharge port are formed on the same surface in the same direction) is shown. FIGS. 11 a and b show an example of a biosensor having two sample transport paths, and FIG. 11 c shows an example of a configuration diagram of a biosensor having four sample transport paths. An example of another array-like biosensor of this embodiment (a structure in which the opening directions of the sample introduction port and the air discharge port are formed on the same surface in the same direction) is shown. 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 array-like biosensor with a cover attached thereto, FIG. 12c shows an example of an array-like biosensor having a protective film adhered thereto. An example of another array-like biosensor of this embodiment (a structure in which the opening directions of the sample introduction port and the air discharge port are formed on the same surface in the same direction) is shown. 13A- (1) is an example of a bonding surface side of a substrate having a wiring pattern on the substrate, FIG. 13A- (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 array-shaped biosensor with a cover attached thereto, FIG. 13c shows an example of an array-shaped biosensor having a protective film adhered thereto. An example of another array-like biosensor of this embodiment (a structure in which the opening directions of the sample introduction port and the air discharge port are formed on the same surface in the same direction) is shown. 14A- (1) is an example of a bonding surface side of a substrate having a wiring pattern on the substrate, FIG. 14A- (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 array-like biosensor with a cover attached thereto, FIG. 14c shows an example of an array-like biosensor to which a protective film is further bonded. An example of an articulated biosensor provided with a protective film is shown. The example of the box-type container which accommodates the biosensor which gave the protective film is shown. The example of a display of the remaining number given to the protective film part of a connection type | mold biosensor is shown.

Explanation of symbols

DESCRIPTION OF SYMBOLS 1 Substrate 2 Cover 3 Spacer 4 Pattern 5 including electrode Terminal 6 Spacer space 7 Sample transport path 8 Sample inlet 9 Air outlet 10 Reagent layer 11 Protective film 12 Detachable layer 13 Non-adhesive part 14 Sample solution 15 Through hole 16 Desiccant 17 Perforation 18 Strong adhesive layer 19 Cut 20 Biosensor 21 Container 22 Lid 23 Portion having removable layer 24 Portion having strong adhesive layer 25 Electrode 26 Number of remaining biosensors

Claims (25)

A biosensor comprising a sample inlet and an air outlet communicating with the sample inlet, wherein the sample inlet and the air outlet can be shielded from the outside of the biosensor, A biosensor comprising a protective film that can be peeled off. 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 sandwiched between the substrate and the cover,
The space between the substrate and the cover is provided with a sample transport path extending from the sample introduction port to the air discharge port through the electrode,
The protective film has a size capable of sealing at least the sample introduction port and the air discharge port, and a removable layer capable of adhering to and peeling from an adhesive surface where the sample introduction port and the air discharge port are present. A biosensor comprising: The biosensor according to claim 2, wherein the sample introduction port and the air discharge port are formed on the same surface. 4. The sample introduction port and the air discharge port are formed on the surface of the substrate, or the sample introduction port and the air discharge port are formed on the surface of the cover. Biosensor. The biosensor according to claim 2, wherein the adhesive surface is a substrate surface or a cover surface. The biosensor according to claim 2, wherein a reagent layer is present on at least an electrode in a region through which the sample transport path passes. The biosensor according to claim 2, wherein the electrodes form an array. The biosensor according to any one of claims 2 to 7, wherein a desiccant and / or an oxygen scavenger is present in a space between the substrate and the cover. The biosensor according to claim 8, wherein the sample transport path and the desiccant and / or oxygen scavenger are separated by an isolation film. The biosensor according to claim 2, wherein the protective film has a portion having a removable layer and a non-adhesive portion. The biosensor according to any one of claims 2 to 10, wherein the protective film is bonded to the adhesive surface through a non-peeling layer that does not peel from the adhesive surface. The biosensor according to any one of claims 2 to 11, wherein a protective film peeling perforation or a cut is formed in a part of the protective film. The biosensor according to claim 2, wherein a protective film folding perforation is formed on a part of the protective film. The biosensor according to claim 2, wherein the protective film is a plastic film. The biosensor according to any one of claims 2 to 14, wherein a part or all of the surface of the protective film on the adhesive surface side is coated with an oxygen scavenger or an oxygen-impermeable material. The biosensor according to any one of claims 2 to 15, wherein a part or all of the surface of the protective film is coated with an ultraviolet absorber or an ultraviolet non-transparent substance. The biosensor according to any one of claims 2 to 16, wherein the substrate is made of an ultraviolet light impermeable substance. The biosensor according to any one of claims 2 to 17, wherein the substrate surface is coated with an ultraviolet absorber or an ultraviolet non-transparent substance. 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. The biosensor according to claim 2, wherein the protective film is bonded to an adhesive surface. The biosensor according to any one of claims 2 to 20, wherein a plurality of the biosensors are regularly arranged at predetermined intervals, and perforations are provided on the connected biosensor substrates. Sensor. A biosensor package comprising a plurality of biosensors according to claim 2. A protective film for simple packaging of a biosensor comprising a sample inlet and an air outlet communicating with the sample inlet, wherein the sample inlet and the air outlet can be blocked from the outside of the biosensor, A simple packaging protective film for biosensors that can be bonded and peeled off from the sensor surface. A method of 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,
A part or all of the protective film is peeled off from the biosensor when the biosensor is used, and the protective film peeled off after the use of the biosensor is adhered again to the biosensor surface, and the sample introduction port and the air discharge port are opened. A method of using a biosensor, wherein the biosensor is sealed by covering with the protective film. The biosensor according to any one of claims 1 to 21,
A measurement unit for measuring an electrical value in the electrode of the biosensor;
A display unit for displaying a measurement value in the measurement unit;
A biosensor device comprising a memory unit for storing the measurement value.

Images