JPH09159642A - Bio sensor and its manufacturing method - Google Patents

Abstract

PROBLEM TO BE SOLVED: To easily perform direct determination and quantification with a small amount of sample liquid, achieve improved liquid leakage resistance, improve ease of use, and reduce cost. SOLUTION: An electrode system is provided at two insulation substrates 1a and 1b which are laminated by providing a space part with a spacer 4 and two connection terminals 23 are separately exposed in opposite directions on both substrates 1a and 1b with both insulation substrates 1a and 1b in outer shape having cut-outs 11a and 11b as a bio sensor. The pattern shape of such electrode system as the outer shape of the substrates 1a and 1b, a lead, electrodes 22 (221) and 22 (222), a connection terminal 23, and an insulation layer is made similar when viewed from an electrode formation surface side to share the substrate when manufacturing both substrates, and a spacer 4 is formed by printing or partially applying to the insulation substrates 1a and 1b.

Description

Detailed Description of the Invention

[0001]

TECHNICAL FIELD The present invention relates to, for example, glucose in blood and specific components in a liquid sample quickly and easily,
The present invention also relates to a biosensor that can be accurately quantified, and more specifically to an easy-to-use and inexpensive biosensor electrode structure that can be easily measured with a small amount of sample, and a manufacturing method thereof.

[0002]

2. Description of the Related Art Conventionally, there have been known biosensors for measuring the abundance of various substances to be measured by utilizing the high molecular recognition ability of bio-related substances such as enzymes in the quantification of specific components in a sample solution. For example, a glucose sensor for quantifying glucose has been put into practical use as an enzyme sensor using an enzyme as a biologically relevant substance. The enzyme sensor
An enzyme having a high substrate specificity for a substance to be measured is immobilized on a substrate such as a polymer membrane, the substance to be measured in a sample is brought into contact with the enzyme, and a substance produced by an enzymatic reaction is electrochemically detected, It can be quantified.

Biosensors are used in various fields, and, for example, in the case of the above-mentioned glucose sensor, it has been commercialized for controlling the blood glucose level of diabetic patients and process control of food processing.
In addition, a biosensor that uses microorganisms (microorganism sensor)
Has been put to practical use, and is used for river water quality analysis and safety management of factory wastewater. In this way, biosensors can be used for medical treatment in the determination of specific components in sample liquids.
Widely used in food analysis, fermentation control, environmental measurement, etc. The measurement at the beginning of practical use had a problem that the device was large and time-consuming and costly, but it is often used in facilities such as hospitals and factories, and its excellent molecular recognition ability makes it unacceptable. There wasn't. However, especially when an individual measures certain components in blood or urine to check their health, illness, or effectiveness of treatment,
Due to the running cost and the difficult operation method, a heavy burden is placed on the user, and an inexpensive sensor that can perform simple on-site measurement has been desired.

For example, a biosensor that can be used as a glucose sensor or the like proposed in Japanese Examined Patent Publication No. 6-76984 is one that enables measurement in a short time by simply dropping a small amount of sample liquid from above. In the same publication, a platinum electrode embedded in a resin-made cylindrical base material is exposed to the electrode portion from the upper and bottom surfaces thereof, a liquid-retaining layer of rayon paper, a filtration layer of a porous membrane, and an enzyme in an annular frame. There has been proposed a biosensor having a structure in which a measuring chip having a reaction layer of a non-woven fabric impregnated with it is installed. However, the structure is complicated, there are many manufacturing processes and components, and it is inevitable that the cost will increase no matter how the device is devised. In addition, Japanese Examined Patent Publication 6-58338
The publication proposes a biosensor that can be used as a glucose sensor or the like, which is of a disposable type.
As shown in FIGS. 6 to 8, this biosensor has a structure in which one end of a lead printed and formed on a resin sheet 91a is used as a connection terminal 923, and the other end of the lead serving as an electrode is used. After printing the electrode material on the top,
An insulating layer 94 is printed so as to expose the connection terminal 923 and the electrodes 922 and 922a to cover the remaining leads, and the reaction layer 9 in which an enzyme is fixed on the electrodes 922 and 922a.
5 is formed as a lower substrate, and a sheet 91b serving as a cover is laminated on the lower substrate through a spacer sheet 97 having a space 96 around the reaction layer 95, and the sample solution is introduced from the inlet port 98 at the tip to a capillary tube. Due to the phenomenon, the space enters the space, and the gas in the space is pushed out from the discharge port 99 by the introduction of the sample solution, so that a small amount of the sample solution can be smoothly exchanged with the gas in the space. It was done.

[0005]

However, although the biosensor as proposed in Japanese Patent Publication No. 6-58338 is disposable and facilitates individual use, it is a skilled and exclusive subject. Unlike the case where an analyst uses it, when it is used by an ordinary individual, it is not always easy to use. It cannot be correctly measured by checking the front and back of the electrode and inserting it into the main body of the measuring device.Moreover, multiple connection terminals are provided adjacent to the same surface of the sheet that serves as the substrate, and the operation is mistakenly measured. This is because if the sample liquid or the like is adhered to another place of the sensor and wets the connection terminal portion, the connection terminals adjacent to each other may be electrically connected to each other. Further, in addition to the two sheets, a spacer sheet cut into a predetermined shape to form a space is required as a component, and there is room for improvement in the structure, which avoids an increase in cost. There wasn't.

[0006]

Therefore, the biosensor of the present invention faces at least the insulating substrate, the electrode system provided on the substrate, and the space provided between the two insulating substrates. In a biosensor having a reaction layer, the outer shape of two insulating substrates is changed to a shape having a cutout for exposing the connecting terminals of the opposing insulating substrates, and the connecting terminals of both insulating substrates are connected to each other. The electrodes and their connecting terminals were separated into two insulating substrates, each having a structure in which the electrodes were exposed in opposite directions. In addition, the two insulating substrates were adhered and laminated via a spacer to secure a space portion facing the reaction layer. Further, as this spacer, one formed by printing or partial application on at least one insulating substrate is used, and a sheet-shaped spacer is not necessary.

The outer shape of the two insulating substrates is
The shape was the same when viewed from the electrode formation surface side, and structurally simple. Further, regarding the shape of each electrode system of the two insulating substrates, one or more of the electrodes, the connection terminals, the leads, the insulating layer, and the like, which form the electrode system, may be formed on the electrode forming surface side of the insulating substrate. From the viewpoint, the structure is also simplified by making the same pattern shape. The same pattern shape was used as the lead connected to the electrode and the connection terminal, and the electrode, the connection terminal and the insulating layer were also formed in the same pattern shape to achieve structural simplification.

Next, the method for manufacturing a biosensor of the present invention comprises a reaction facing at least an insulating substrate, an electrode system provided on the substrate, and a space provided between two insulating substrates. In the method for manufacturing a biosensor having a layer,
The biosensor has an electrode and a connection terminal on one side.
The two insulating substrates are bonded and laminated via a spacer so as to leave a space, and the outer shapes of these two insulating substrates are cut to expose the connection terminals of the opposing insulating substrates. An insulating substrate that has a notched portion and that faces the insulating substrate when the insulating substrates are laminated facing each other before, during, or after the step of forming the electrode system and the reaction layer on the insulating substrate. A notch is formed at least at the boundary between the notch for exposing the connection terminal and the main body of the insulative substrate where the notch is left, and then two insulative substrates are overlapped with each other by a spacer. After bonding and laminating, both insulating substrates are cut into a predetermined sensor shape, so that the connection terminals of both insulating substrates are exposed to the opposite sides by the notches so that the electrodes and the connection terminals are separated from each other.
A biosensor having a structure in which it is separated into one insulating substrate is easily manufactured.

Further, the shape of the cutout portion is manufactured so that both insulating substrates after cutting into the sensor shape have the same shape when viewed from the electrode forming surface side.

For each of the electrode systems of the two insulating substrates, one of lead, electrode, connection terminal and insulating layer connected to the electrode and the connection terminal constituting the electrode system.
Regarding the above, they are formed in the same pattern shape as viewed from the electrode formation surface side of the insulating substrate. At least the lead is used, and the lead, the electrode, the connection terminal, and the insulating layer are also formed in the same pattern shape.

Further, the notch is formed in the boundary of the notch by half-cutting leaving a part of the insulating substrate in the thickness direction, and the two insulating substrates are superposed and adhered to each other. By completely separating the incision by cutting, separating the notch, and before or after cutting into the sensor shape, by a method of separating unnecessary notches,
Facilitated manufacturing by multiple imposition. In addition, the spacer
A notch formed on at least one of the insulating substrates by printing or partial application, and a notch formed at least at the boundary between the notch and the main body of the insulating substrate is performed before or after the spacer forming step, and a sheet-like spacer is formed. It was a method that can be manufactured without using.

[0012]

BEST MODE FOR CARRYING OUT THE INVENTION Embodiments of the biosensor of the present invention and a method for manufacturing the same will be described below with reference to the drawings. 1, 2 and 3 are views showing an embodiment of the biosensor of the present invention, FIG. 1 is an exploded perspective view thereof, FIG. 2 is an external view, and FIG. 3 is a sectional view. The biosensor 10 of the present invention shown in these drawings has two insulating substrates 1.
a and 1b have a structure in which they are adhered and laminated via the spacer 4 so as to leave a space 6 facing the reaction layer 3, and both insulating substrates before lamination are bonded to the electrode system on the inner surface side thereof respectively. It has a spacer 4 for stacking. The electrode system of both substrates is composed of a lead 21, an electrode 22, a connection terminal 23, and an insulating layer 5. One end of the lead 21 forms the connection terminal 23 (also serves as a connection terminal), and the other end thereof has the electrode 22 as the lead 21.
The unneeded portion formed above is covered with the insulating layer 5.
A reaction layer 3 containing a biological substance such as an enzyme is formed on the electrode 22 of the lower insulating substrate 1a to serve as a working electrode 221, and the electrode of the other substrate serves as a counter electrode 222. The spacer 4 is formed on the insulating substrate as a linear pattern on both sides so that the space 6, the inlet 61 and the outlet 62 for contacting the reaction layer with the sample solution are left. As a result, the inlet 61 for introducing the sample liquid to the side end surface portion on the side without the connection terminal is opened by sandwiching both sides by the spacer, and the outlet for discharging the gas in the space portion to the side end surface portion on the connection terminal side. It has a structure in which 62 is opened. Note that it is also one of the preferable modes to provide the discharge port inside the insulating substrate, and in this case, for example, the discharge port may be provided as the discharge port 62a shown by the dotted line in FIG. In this case, the space portion on the connection terminal side from the discharge port 62a on the far side of the introduction port 61 may be filled with a spacer. By providing the discharge port 62a, even if the space portion is continuous to the side end surface on the connection terminal side and opens there, the sample liquid reaching the opening portion on the connection terminal side overflows and the connection terminal is abruptly opened. It also has the effect of avoiding getting wet.

The outer shapes of the two insulating substrates 1a and 1b have cutouts 11a and 11b as shown in the figure, so that the connecting terminals of both insulating substrates can be exposed to the outside. I have to. Further, by making the outer shapes of both insulating substrates each having a notch part the same as seen from the inner surface side having the electrode system, it is possible to commonly use a punching die for both substrates at the time of manufacturing. .

As described above, the biosensor of the present invention has two features.
It is composed of two insulating substrates, and an electrode system (for example, a working electrode and a counter electrode) is formed on both of these two insulating substrates, and the electrode forming surfaces are separated so as to face the inside (reaction chamber side) and face each other. The basic features of the geometrical structure in which the cutouts are provided in both insulating boards to expose the measurement terminals of both insulating boards and enable external connection. There is. As a result, compared with the conventional biosensor in which the electrode system is provided on one side of the two-layered insulating substrate, even if the undesired portion gets wet, the connection terminal portion does not conduct, and it is easy for an unfamiliar individual to use. Will be obtained. In addition, in the configuration where the reaction layer is not provided on the electrode of one insulating substrate and the reaction layer is provided on the electrode of the other insulating substrate, the reaction occurs during the measurement algorithm that applies the potential to the electrode system of the biosensor on the measuring device main body side. Incorporate a process for determining which side the electrode provided with the layer is (for example, before applying the potential for this measurement, to the electrochemically active substance used in the reaction layer, preferably the mediator). On the other hand, the potential is rapidly applied and swept to either one of the electrodes from immediately before its own redox potential to the oxidation potential, and the increment of the response current is measured. Is determined to have been applied to the correct electrode side.), And if the normal potential after the determination is applied to the correct electrode immediately, the side with the connection terminal should be checked after each measurement. There is no need to be inserted into, and very easy to use. It should be noted that the shape of the notch may be intentionally made different between the two insulating substrates to prevent erroneous connection (working electrode and counter electrode) when setting the sensor in the measurement device. It is also possible to visually recognize a structurally different shape on the measuring device side. Also, if the notch shape is the same shape when viewed from the electrode formation surface side on both insulating substrates, a punching die for punching the insulating substrate into a predetermined shape in the manufacturing method can be commonly used for both upper and lower substrates, Cost can be reduced.

As shown in FIGS. 1 and 2, the pattern shape of the electrode system is the same for both insulating substrates, so that the printing plate can be commonly used in the electrode system formation usually performed by screen printing. Further, this brings about an advantage that the upper and lower insulating substrates can be manufactured without distinction in the manufacturing process, leading to cost reduction. The electrode system is usually a lead,
Conductive parts such as electrodes and connection terminals and insulating layers are components, but if one of these has the same pattern, the cost merit can be obtained, and if all of them have the same pattern ( 1 and 2), the effect becomes larger. Among them, the leads are easily formed into the same pattern for that purpose, and the connection terminals are often formed at the same time with the same material as the leads, and in this case, they can be regarded as a part of the leads. It should be noted that when the pattern shape of the electrode system is the same shape, it means that the same shape exists at the same position on the insulating substrate, but even if the same shape is at a shifted position on the substrate, the printing plate Has the advantage of being common,
This meaning is also included.

Materials such as the insulating substrate, the electrode system, the reaction layer, and the spacers and their formation may be appropriately selected from materials and methods known in the art, which are suitable for the intended use. For example, a resin sheet made of polyethylene terephthalate (hereinafter PET) or the like is used for the insulating substrate. In the electrode system, the leads and the connection terminals may be conductive paste containing a metal such as silver or gold, the electrodes may be carbon paste, and the insulating layer may be an insulating paste, which may be formed by screen printing. If the enzyme sensor is used as a glucose sensor, the reaction layer may be a layer on which glucose oxidase is immobilized, and the reaction layer is formed by screen-printing an enzyme-containing ink or applying a coating liquid with a dispenser. In addition to this, there may be a layer for controlling the permeation of the sample liquid sample, for example.

A PET sheet is used for the spacer, and PET is used.
The insulating substrates may be bonded and fixed to each other with an adhesive via a sheet, but since a sheet having a predetermined shape is required to form the space portion, at least one of the insulating substrates (the space portion is formed). It is advantageous to use a pattern formed by printing or partial coating (in such a pattern) in terms of reduction of the number of parts and cost reduction. The spacer forming means for printing or partial application may be appropriately selected depending on the material used. Screen printing is preferable because it can be formed thick, but a material that is not suitable for printing is partially applied by an applicator such as hot melt or a plate shape for application. Manufacturing is usually done by multiple faces, but if it is a continuous stripe shape that is continuous with adjacent sensors or an intermittent stripe shape that is discontinuous between adjacent sensors, it is relatively easy to apply and form materials that are not suitable for printing. it can. As the spacer material by printing or partial application, for example, a hot-melt adhesive such as a heat-activatable thermosetting adhesive or a hot-melt adhesive such as a hot-melt adhesive such as a thermoactive thermosetting adhesive is used. Acrylic resins and silicone elastomers can be used as these resin components. In addition, additives such as fillers are added as appropriate to improve printability and coating suitability. Then, two insulating substrates are laminated and heat and, if necessary, an appropriate pressure are applied, the formed spacers are activated by heat, and both insulating substrates are bonded and fixed. In addition, the adhesive or adhesive may be printed or applied once to provide a desired space between the insulating substrates (a space for accommodating the thickness of the electrode system in the space to allow the sample liquid to reach and contact the reaction layer). If it is not possible to form a film having a thickness of about 50 to 300 μm), printing or coating may be repeated a plurality of times. In this case, the layers having the thickness function may be sandwiched between the layers having the thickness function, instead of the same material. The layer having the thickness function does not need to have a function of exhibiting adhesive force by heat, and may be a screen printing ink or the like that can be thickly formed, for example, an insulating paste or the like that can be thickly formed. When the spacer is formed after the reaction layer is formed, it may be covered with a protective layer so that the reaction layer can be protected even if a measurement-interfering substance comes out of the spacer. For example, in the case of a reaction layer containing glucose oxidase, an ink or coating liquid containing phospholipid is printed or applied.

In order to provide the cutout portion, the electrode systems facing each other are likely to be damaged after the both insulating substrates are laminated. Therefore, the notched portion is punched out or cut in a state before lamination, or half-cut and cut after lamination. Although the notch may be cut completely at the boundary between the notch and the insulating substrate body, the notch may be cut completely, or may be cut halfway and the two insulating substrates may be separated after being laminated. In addition, half cut is
One of the insulating substrates may be used. Half-cutting has the advantage of preventing dust in the cutouts from being scattered during manufacturing. The timing of the step of making a notch may be before, during, or after the series of forming steps, including the electrode system, the reaction layer, and the spacer when the spacer is formed by printing or partial coating. However, it does not hinder the formation of these. For example, one form is after all formations. In the multi-sided manufacturing, when the spacer is formed into a continuous stripe shape continuous with the adjacent sensor and passes through the cutout portion (FIG. 4 described later), if the cutout is formed after forming the spacer, it is formed in the cutout portion. It is also possible to remove unnecessary spacers. At this time, if a spacer is formed on the opposite insulating substrate, the spacer remains exposed in the vicinity of the connection terminal. However, such a phenomenon does not occur if the spacer formation is discontinuous even if the spacers are formed in the same stripe shape (no notch is formed). In the case of forming spacers on both insulating substrates, if the spacers are formed in the same shape, the advantage of being common to both substrates such as printing plates can be obtained.

Next, the above-mentioned biosensor is manufactured.
One of the manufacturing methods of the present invention is a method of providing a notch for exposing a connection terminal, which is to be put to practical use in manufacturing by practical multi-sided attachment. In addition, the shape of the notch and the pattern of the electrode system are formed in the same shape on two insulating substrates, the spacer is also formed by printing or partial coating, and half cut is used to form the notch. It is also a manufacturing method. One form of the manufacturing method is the manufacturing process shown in FIG. 4, which is based on the assumption of multi-sided manufacturing.
(A) [Hereinafter, "FIG. 4" is omitted] and the like shown by a broken line in a rectangle (ignoring the cutout portion) means the outer shape of the insulating substrate of a portion which becomes one sensor. In the manufacturing process shown in FIG. 4, a cutout portion having the same shape, a (final) insulating substrate having the same shape, an electrode system (leads, electrodes, connection terminals and insulating layers) having the same shape, a spacer formed by printing or partial formation. This is the case of forming. In addition, the spacers are formed on both substrates in the same shape.

First, the insulating substrate 1 is prepared (a), the leads 21 which also serve as the connection terminals 23 are formed (b), the electrodes 22 are formed (c), and then the insulating layer 5 is formed. An electrode system is formed as a final electrode (exposed) shape (d). Up to this point, the upper and lower insulating substrates are commonly handled. Next, the reaction layer 3 is formed on the electrodes on one of the substrates (e). Then, the spacer 4 is formed on the substrate on which the reaction layer is formed (f-1), and the spacer 4 having the same shape is formed on the other substrate (f-2). The notch 11 is punched out and separated from these substrates (g-1) and (g-
2). When the discharge port is provided, one substrate may be formed at the same time in this step. Then, two upper and lower insulating substrates are laminated, heat and pressure are applied, and after bonding and fixing with spacers, the periphery is punched out to form the final sensor outer shape,
One biosensor (h).

In FIG. 5, the cutout portion 11a is provided in a multifaceted manner.
And 11b are provided, a form of a notch formed in the boundary lines 12a and 12b between the notch and the insulating substrate main body is shown, and a final shape for forming the outer shape of the sensor is shown. It is explanatory drawing which shows 13. In addition,
For the sake of explanation, this figure shows four vertical and horizontal sides extracted,
In reality, each notch has a quadrilateral shape with four sides enclosed. In the case of multi-sided mounting, usually, a space is provided around each sensor shape and the sensor shapes are arranged adjacent to each other. Therefore, in the manufacturing method, the shape of the cutout portion and the meaning of the cutout formed at least at the boundary between the cutout portion and the insulating substrate body portion are clarified in relation to the blank space. By extending the cut to this margin, even if it is slightly misaligned when finally punching into the sensor shape, the external shape can be connected and cut cleanly. Similarly, when the cutout portion is cut and deleted in advance, the margin is slightly included. Therefore, the shape after the notch is removed is a shape that includes some margins. In the manufacturing method, the meaning that the shape of the cutout portion is the same on both substrates basically means at least a virtual shape of the portion excluding this margin. Of course, if the cut shape in the margin is the same, the shape including the margin may be used.

[0022]

EXAMPLES Next, the present invention will be explained with reference to examples. In this example, the biosensor having the shape and structure shown in FIG. 4 is manufactured by multi-sided attachment, and the outer shapes of the upper and lower insulating substrates having the notches, the electrode system, and the spacer shape formed on the substrate are formed. Have the same shape. First, a silver paste is screen-printed on a 250 μm-thick PET sheet as an insulating substrate and then fired to form leads and connection terminals, and then a carbon paste is screen-printed and fired to form electrodes. After the insulating paste is screen-printed, it is baked to form an insulating layer, thereby forming an electrode system. Then, the notch is punched out and separated. The obtained sheet has a notch portion opened and is used as both upper and lower insulating substrates. Then, a mixed ink of glucose oxidase and ferrocenecarboxylic acid is screen-printed on the electrode portion of the sheet serving as the substrate on one side and then dried to form a reaction layer. Then, as shown in FIG. 4, the other sheet serving as the counter electrode and the sheet serving as the working electrode in the reaction layer are screen-printed with ink containing a heat-activatable thermosetting adhesive and dried to form spacers (note that , Can also be manufactured by forming a spacer on either one of them). Then, stack both sheets and bond them with a spacer by heat and pressure.
After stacking and fixing, punching is performed to obtain the final sensor shape.

[0023]

Industrial Applicability According to the present invention, the biosensor can be easily measured with a small amount of sample, and it can be used easily and inexpensively. If the outer shape of the two insulating substrates and the pattern of the electrode system such as leads are the same, the manufacturing process can be shared by both substrates, and even if the electrode systems are provided on both substrates, an inexpensive sensor can be obtained. Further, if the spacers are printed or partially applied spacers, a spacer sheet is not required, so that the number of constituent parts can be reduced and an inexpensive sensor can be obtained. Further, according to the manufacturing method of the present invention, the biosensor can be efficiently manufactured. By making the outer shape and the electrode system pattern the same shape, manufacturing of both upper and lower insulating substrates can be made common, a common printing plate and a common cutting die can be used, and a cost reduction effect can be obtained. Further, if the notch for exposing the connection terminal is cut by a half cut, dust in the notch can be prevented from being scattered during manufacturing, and the manufacturing can be facilitated.

[Brief description of the drawings]

FIG. 1 is an exploded perspective view showing a structure of an embodiment of a biosensor of the present invention.

FIG. 2 is an external view of the biosensor of the present invention in FIG.

3 is a cross-sectional view taken along line AA (FIG. 2) of the biosensor of the present invention in FIG.

FIG. 4 is a process explanatory view assuming multi-faced attachment as one form of the biosensor manufacturing method of the present invention. (A) Insulating substrate whose periphery is not cut in the shape of the sensor, (b) Lead formation,
(C) Electrode formation, (d) Insulation layer formation, (e) Reaction layer formation, (f-1, 2) Spacer formation, (g-1, 2,) Notch formation at boundary of notch, (h) Top and bottom After stacking and adhering the substrates, the surrounding area is punched out into a sensor shape.

FIG. 5 is an explanatory view of a cutout portion when the method for manufacturing a biosensor of the present invention is performed in multiple faces.

FIG. 6 is an exploded perspective view showing an example of the structure of a conventional biosensor.

FIG. 7 is an external view of the conventional biosensor of FIG.

8 is a line AA of the conventional biosensor of FIG. 6 (FIG. 7).
Sectional view at.

[Explanation of symbols]

 1, 1a, 1b Insulating substrate 11a, 11b Notch 12 Boundary between notch and insulating substrate body 13 Punching shape when forming the outer shape of sensor 21 Lead 22 Electrode 221 Working electrode 222 Counter electrode 23 Connection terminal 3 Reaction Layer 4 Spacer 5 Insulating Layer 6 Space 61 Inlet 62 Outlet 10 Biosensor 91a Sheet (Substrate) 91b Sheet (Cover Sheet) 921 Lead 922, 922a Electrode 923 Connection Terminal 94 Insulating Layer 95 Reaction Layer 96 Space 97 Spacer sheet 98 Inlet port 99 Outlet port

Claims (14)

[Claims] 1. A biosensor having at least an insulating substrate, an electrode system provided on the substrate, and a reaction layer facing a space provided between the two insulating substrates. The shape of the insulating board has an outer shape with a cutout for exposing the connecting terminals of the opposing insulating board, and the connecting terminals of both insulating boards are exposed in opposite directions. A biosensor characterized by. 2. The biosensor according to claim 1, wherein two insulating substrates each having an electrode and a connection terminal on one surface are bonded and laminated via a spacer so as to leave a space. . 3. The biosensor according to claim 1, wherein the two insulating substrates have the same outer shape when viewed from the electrode forming surface side. 4. For each electrode system of the two insulating substrates, one or more of leads, electrodes, connection terminals, and insulating layers, which constitute the electrode system, are connected to electrodes and connection terminals, The biosensor according to any one of claims 1 to 3, wherein the biosensor has the same pattern shape when viewed from the electrode formation surface side of the insulating substrate. 5. The biosensor according to claim 4, wherein the components having the same pattern shape are at least leads. 6. The biosensor according to claim 4, wherein the constituent elements having the same pattern shape are a lead, an electrode, a connection terminal, and an insulating layer. 7. The biosensor according to claim 1, wherein the spacer is formed by printing or partial application on at least one insulating substrate. 8. A method for manufacturing a biosensor comprising at least an insulating substrate, an electrode system provided on the substrate, and a reaction layer facing a space provided between the two insulating substrates, The biosensor has an electrode and a connection terminal on one side.
The two insulating substrates are bonded and laminated via a spacer so as to leave a space, and the outer shapes of these two insulating substrates are cut to expose the connection terminals of the opposing insulating substrates. The shape of the insulating substrate is such that it has a notched portion, and when the insulating substrates are laminated facing each other before, during, or after the step of forming the electrode system and the reaction layer on the insulating substrate, A cut is made at least at the boundary between the notch for exposing the connection terminal and the main body of the insulating substrate where the notch is left, and then two insulating substrates are overlapped with each other with a spacer. After adhering and laminating, both insulating substrates are cut into a predetermined sensor shape, and the connection terminals of both insulating substrates are exposed in the cutout portions in opposite directions. 9. The manufacturing method according to claim 8, wherein the notch is formed so that both insulating substrates after being cut into a sensor shape have the same shape when viewed from the electrode formation surface side. Biosensor manufacturing method. 10. For each of the electrode systems of the two insulating substrates, one of the lead, the electrode, the connection terminal, and the insulating layer, which constitutes the electrode system, is connected to the electrode and the connection terminal.
10. The method for manufacturing a biosensor according to claim 8 or 9, wherein the same pattern shape is formed as seen from the electrode formation surface side of the insulating substrate. 11. The method for manufacturing a biosensor according to claim 10, wherein at least the leads are formed in the same pattern shape. 12. The method for manufacturing a biosensor according to claim 10, wherein the lead, the electrode, the connection terminal, and the insulating layer are formed in the same pattern shape. 13. A notch formed at the boundary of the notch,
Performing a half-cut that leaves a part of the insulating substrate in the thickness direction, and after overlapping and adhering and stacking two insulating substrates, completely cut the cut by the half-cut and cut off the notch. 8. The method according to claim 8, wherein
2. The method for manufacturing the biosensor according to any one of 2 above. 14. A spacer is formed on at least one of the insulating substrates by printing or partial coating, and a notch formed at least at the boundary between the notch and the main body of the insulating substrate is formed before or after the spacer forming step. The method for manufacturing a biosensor according to any one of claims 8 to 13, which is performed later.