JPH0266453A - Production of means for inspecting information on living body - Google Patents

Abstract

PURPOSE:To prevent an adhesive agent from bleeding into apertures for observation and apertures for taking body fluid by adhering and integrating base raw sheets or bases to each other by the adhesive agent provided to the surface except the front surface near the apertures of the base raw sheets or the bases. CONSTITUTION:A 1st base raw sheet 1 having the apertures 3 opened in one row is prepd. and the adhesive agent 4 is provided to the surface except the surface near 7 the apertures 3 of the 1st base raw sheet 1. A long-sized reagent member 5 contg. a reagent to develop a color by reacting with body fluid is then superposed on the apertures 3 disposed in one row on the surface provided with the adhesive agent 4. A 2nd base raw sheet 2 which has the same size as the size of the above-mentioned 1st sheet 1 and has the apertures 6 for taking body fluid opened in one row in correspondence to the apertures 4 for observation provided to the 1st sheet 1 is then superposed on the 1st sheet in such a manner that the apertures 3 and the apertures 6 align to each other. The 1st sheet 1 and the 2nd sheet 2 are integrated by adhering.

Description

[Detailed Description of the Invention] [Industrial Application Field] The present invention relates to a method for manufacturing a biological information testing device, and more specifically, the present invention relates to a method for manufacturing a biological information testing device, and more specifically, a biological information testing device that is easy to handle and allows for the confirmation of biological information test results at a glance. The present invention relates to a method for manufacturing a biological information testing device that allows testing devices to be manufactured efficiently at all times.

[Prior Art and Problems to be Solved by the Invention] As a biological information testing tool used to collect and test saliva, etc. to check the oral environment and systemic diseases, we are A biological information testing element whose color tone changes due to reaction with a sample (body fluid) is provided with a support having an observation opening for visually confirming a change in color tone of the biological information testing element; A biological information testing device has been proposed in which the biological information testing device is sandwiched between a support body having an opening for collecting body fluid for supplying body fluid, and the supports are adhered to each other with an adhesive.

This biological information testing device includes, for example, a biological information testing element that tests biological information and shows the test results as a change in color tone.One support has an opening for observation, and the other has an opening for body fluid collection. A support body is sandwiched between the observation opening and the body fluid collection opening, and both supports are bonded and integrated with an adhesive applied to the surface of the support other than the area where the biological information testing element is arranged. Manufactured by

The biological information testing device manufactured in this manner is very convenient as it can easily test biological information, but upon further study, we have discovered that it has the following problems.

In other words, when one support body and the other support body are bonded together with an adhesive with a biological information testing element in between, if the adhesive applied to the surface of the support body protrudes into the opening provided in the support body. This is a problem.

If the opening provided in the support is an observation opening, if the adhesive that protrudes into the opening narrows the opening, it will be difficult to confirm the change in color tone of the biological information testing element, or the opening will become narrower. If the adhesive that protrudes into the opening closes the opening, it becomes completely impossible to confirm the change in color tone of the biological information testing element.

In addition, when the opening provided in the support is for collecting body fluid, if the adhesive that protrudes into the opening narrows the opening, a sufficient amount of body fluid will be collected for the biological information testing element to develop color. Furthermore, if the adhesive that has protruded into the opening closes the opening, it becomes impossible to collect body fluids at all.

In particular, when manufacturing a biological information testing device with a smaller opening, the above-mentioned problems are more likely to occur, resulting in a high number of defective products and poor manufacturing efficiency.

This invention has been made based on the above circumstances.

That is, an object of the present invention is to provide a method of manufacturing a biological information testing device that is easy to handle and that allows the biological information testing results to be clearly confirmed at a glance, which can be manufactured efficiently at all times.

[Means for solving the above problems] The structure of this invention for solving the above problem is as follows.

A biological information testing element that examines biological information and shows the test result by a change in color tone is mounted on one support body having an opening for observation and the other support body having an opening for body fluid collection. In the method of manufacturing a biological information testing device sandwiched between an opening for body fluid collection and the opening for body fluid collection, one of the supports has an opening that serves as the body fluid collection opening or the observation opening. The film and the other support material are bonded together with an adhesive provided on the surface of the support material other than the surface near the opening, and the obtained biological information testing device material is used for individual biological information testing. Another invention of the present application is a method for manufacturing a biological information testing device characterized by cutting the device into pieces. Manufacture of a biological information testing device which is sandwiched between the observation opening and the body fluid collection opening, with one support having a section and the other support having a body fluid collection opening. In the method, one support having an opening that serves as an opening for body fluid collection or an observation opening and the other support are bonded on a surface other than the surface near the opening of the support. This is a method for manufacturing a biological information testing device, characterized in that the device is bonded and integrated with an adhesive.

[Function] In the method of the present invention, the original supports or the supports are bonded and integrated with each other using an adhesive provided on the original support or on the surface of the support other than the surface near the opening.

Therefore, even if the adhesive spreads near the opening during bonding and integration, the adhesive will not protrude into the opening.

Any adhesive that spreads near the opening remains near the opening on the support surface.

As described above, according to the method of the present invention, the adhesive does not protrude into the observation opening and the body fluid collection opening.

[Examples] Next, examples of the present invention will be explained with reference to the drawings.
I do it.

(Example 1) This example deals with manufacturing a biological information testing device from an original support.

In this embodiment, the biological information testing device is manufactured as follows.

That is, as shown in FIG.
An original support 1 is prepared, and an adhesive 4 is applied to the surface of the first original support 1 other than the surface near the opening 3 .

Next, a long reagent member 5 containing a reagent that develops color by reacting with body fluids is superimposed on the openings 3 arranged in a row on the surface where the adhesive 4 is provided.

Thereafter, a second support material having the same size as the first support material 1 is prepared, and a second support material having a slotted opening corresponding to the opening in the first support material material is prepared. For example, a second support material 2 having body fluid collection openings 6 opened in a row corresponding to the observation rMo section 3 accommodated in the first support material 1 is connected to the observation opening. The first support material l and the second support material material 2 are bonded and integrated by overlapping each other so that the part 3 and the opening 6 for body fluid collection coincide with each other.

By cutting the integrated original fabric, as shown in FIG. 2, a first support 8 having an observation opening (not shown in FIG. 2) and an opening 6 for body fluid collection are formed. A biological information test containing a reagent that reacts with body fluids and develops a color, the second support body 9 having a second support body 9 disposed between the observation opening and the body fluid collection opening 6. A biological information testing tool 11 having the element 10 sandwiched therebetween is obtained.

Next, this embodiment will be described in further detail.

- First support material - Materials for the first support material include, for example, thin, shape-retaining materials such as synthetic resin plates, thin metal plates, paper, synthetic paper, nonwoven fabrics, thin wood boards, etc. can be mentioned.

The first support material has openings opened in a negative row, for example, observation openings opened in a row.

The observation opening has a function of allowing visual confirmation of a change in color tone of the biological information testing element.

The observation opening may be made of, for example, a transparent material, or may be simply hollow.

Examples of the transparent material include cellulose acetate,
Transparent polymeric materials such as polyethylene terephthalate, polycarbonate, polystyrene can be suitably used.

As will be described later, this first support material becomes a first support in a biological information testing device after being cut. If the biological information testing method is to visually determine the degree of color development in the biological information testing element, a synthetic resin layer of the first support material to be cut and divided into the first support material is provided. It is preferable to print an appropriate mark in the same color as the biometric information testing element and test results on the surface of the first support. If you print out the test results, you can easily know the results of the biological information test by looking for a mark that has the same color as the color produced by the body fluid on the biological information test element and referring to the test result that corresponds to the mark obtained. can.

-1 Adhesive 11 In the above embodiment, the adhesive is provided on the surface of the first support material other than the surface near the opening.

The adhesive that can be used in the method of the present invention can be appropriately selected and used depending on the first support material, reagent member, and second support material to be used.

Examples of the adhesive include aqueous adhesives such as urea resins and polyvinyl alcohol resins; emulsion adhesives such as vinyl acetate resins and acrylic resins; solvents such as chloroprene rubbers and nitrile rubbers. Mold adhesive;
Solvent-free adhesives such as epoxy resins and urethane resins,
Examples include solid adhesives (hot melt adhesives) such as casein, glue, polyvinyl alcohol resins, ethylene-vinyl acetate copolymers, and polyamide resins.

Examples of the method for applying the adhesive include:

Examples include coating methods using printing methods such as letterpress printing, intaglio printing, and planographic printing, coating methods using a spatula, coating methods using a roll coater, and coating methods using a wire bar. .

In addition, when using the method of applying the adhesive, the surface of the first support material near the opening may be masked and applied.

The range (size) of the vicinity of the opening in the first support material is appropriately set depending on the amount and fluidity of the adhesive used and various manufacturing conditions.

11 Reagent member 11 In this embodiment, a long reagent member is placed a on the surface of the first support material on which the adhesive is provided, over the openings arranged in the - row. .

This reagent member is cut to become a biological information testing element sandwiched between the first support and the second support.

The structure of the reagent member is the same as that of the biological information testing element, except that the reagent member is cut to become the biological information testing element. do.

The biological information testing element contains a reagent that can be colored by a test sample that is a body fluid such as saliva, sweat, or urine.

Specifically, as shown in FIG.
0, a support member 12 and a reagent layer 13 containing four coloring reagents.
and a spreading layer 14 for spreading the collected body fluid can be constructed by planting layers in this order.

The support member is not particularly limited as long as it is liquid-impermeable, but
For example, it can be formed from a transparent synthetic resin film or sheet such as cellulose acetate, polyethylene terephthalate, polycarbonate, or polystyrene.

The reagent layer may be formed by applying it onto the supporting member using various coating methods and then drying it. For example, the reagent layer for biological information testing described later may be applied to a porous material such as paper or nonwoven fabric. It may also be formed by impregnating or adsorbing it.

The developing layer is used to: 1) spread a certain amount of sample uniformly per unit area of the reagent layer, 2) remove substances or factors that inhibit the color reaction in the sample, and 2) provide observation light when performing color observation. For example, a non-fibrous porous spreading layer called a plush polymer made of titanium dioxide and cellulose diacetate, JP-A-56-245
No. 76, No. 57-125847, No. 57-19746
A spread layer having a fibrous structure described in No. 1, etc. can be suitably used.

Note that the biological information testing element may simply consist of a reagent layer containing a coloring reagent. When using a biological information testing element that simply consists of a reagent layer,
A transparent member having the same function as the support member is provided in the opening of the first support material or the first support material, and a transparent member having the same function as the support member is provided in the second support material material or the second support material. It is preferable to provide a deployable member having a width similar to that of the deployable layer in the opening for body fluid collection.

(Biological Information Testing Reagent) The biological information testing reagent in the biological information testing element is not particularly limited as long as it reacts with body fluids to develop a color.For example, PH of saliva, glucose, nitrite, alcohol in saliva. Oral reagents capable of detecting one or more of , mercaptans, amino acids, lactic acid, blood, and enzymes can be suitably used. Which biological information test reagent to use?
It is determined as appropriate depending on what items are to be tested on the subject with this biological information testing tool.

For example, if testing the bad breath of a test subject, the oral cavity reagent should contain a diazo component that develops a color through a diazo reaction with nitrite ions in saliva, and a coupling agent that undergoes a coupling reaction with the diazo component. can be formed with.

Examples of the diazo component include amine compounds having 7 primary amine groups, and preferred amine compounds include heterocyclic compounds, aromatic amines, and derivatives thereof.

These amine compounds can also be used in the form of inorganic salts, such as hydrochlorides, sulfates, organic acid salts, and the like.

Further, examples of the coupling agent include aromatic compounds having an amino group and/or hydroxyl group and derivatives thereof. Further, when the cubulating agent is an aromatic amine, it can also be used in the form of its organic or inorganic acid salt.

In the case of bad breath testing, the diazo component and the coupling agent can be used as a diazo reaction coloring reagent.

Regarding this diazo reaction coloring reagent, the mixing ratio, concentration, etc. of the diazo component and the coupling agent can be adjusted as appropriate so as to cover the concentration range of nitrite ions that can be detected.

Further, the diazo reaction coloring reagent can usually be used after being dissolved in a polymer acid solution.

Examples of polymer acids include JP-A-59-44659 and JP-A-59-44659;
Polymer acids or strongly acidic or weakly acidic cation exchange resins described in Japanese Patent No. 9-94552 and the like can be used.

Preferred polymer acids include, for example, polyacrylic acid, polymethacrylic acid, acrylic acid-butyl acrylate copolymer (50:50), ethylene-monobutyl maleate copolymer, polystyrene sulfonic acid, acrylamide-2-methylethane. Sulfonic acid-butyl acrylate-styrene copolymer (15:80:5), poly-2-methacryloylethyloxyphosphate, 2-
Examples include acrylamide-2-methylpropanesulfonic acid-butylene acrylate copolymer (50:50). In addition, in the above, the numbers in parentheses indicate weight %.

In addition to the above, as an oral reagent for testing bad breath, 4.4'
-bisdimethylaminodiphenylcarbinol, 5,5
'-dithiobis(2-nitrobenzoic acid) or the like may be used, or a reagent that detects methyl mercaptan or other thiol compounds in exhaled breath may be employed.

The oral cavity reagent may contain auxiliary substances such as surfactants and preservatives, if necessary.

A woody polymer is suitably used as the binder for the reagent layer.

Examples of the wood-philic polymer include gelatin and gelatin derivatives such as phthalate gelatin, polyvinyl alcohol, polyvinylpyrrolidone, polyacrylamide, polymethacrylamide, and cellulose derivatives such as carboxymethyl cellulose sodium salt and hydroxyethyl cellulose. be able to.

Among these, phthalated gelatin, polyacrylamide, polyvinyl alcohol, polyvinylpyrrolidone, hydroxyethylcellulose and the like are preferred.

m-Second support material--1 In this example, the second support material has observation sections arranged in - rows on the surface of the first support material on which the adhesive is provided. with a reagent member placed thereon so that the opening in the first support original and the opening in the second support original are aligned;
are superimposed.

In any case, as the raw material for the second support, the first
It is the same as the material of the original support.

This second support material has openings opened in a negative row, for example, openings opened in a row for body fluid collection.

Note that, in this second support material, an opening having the same shape as the opening in the first support, for example, is formed in the opening of the first support material so as to correspond to the opening in the first support. Arrange them in a row with the same spacing as between the two.

The opening for body fluid collection collects a sample for biological information testing, such as saliva, and transfers the collected sample uniformly and uniformly to the biological information testing element, thereby providing a uniform flow to the biological information testing element. It has the function of promoting color development.

In addition, if it has such a function.

For example, the opening for body fluid collection may be formed using a flexible porous material, and when using a biological information testing element having the above-mentioned development layer 14, such a function may be developed. If layer 14 has an opening for body fluid collection, it may simply be a cavity.

Examples of the porous material include liquid-permeable materials such as woven fabrics, nonwoven fabrics, filter paper, Japanese paper, glass fibers, synthetic fibers, and natural fibers.

- A reagent layer positioned between the observation section and the body fluid sampling section is sandwiched between the first support original fabric and the second support fabric, and the first support original fabric The biological information testing device raw fabric formed by adhering and integrating the first support raw fabric and the second support raw fabric with an adhesive provided on a surface other than the surface near the opening is cut, and the first
A biological information testing element positioned between an observation opening and a bodily fluid collection opening is sandwiched between the support and the second support, and the first support and the second support are A biological information testing device is obtained which is integrally bonded.

In this biological information testing device, body fluid is normally applied to the body fluid collection opening by an appropriate means. Specifically, for example, saliva applied to a finger is applied to an opening for body fluid collection. Saliva supplied to the opening for body fluid collection moves and diffuses to the biological information testing element, and the saliva that is applied to the body fluid collection opening moves and diffuses to the biological information testing element. The reagent develops color by reacting with the color reagent. This color change is measured through an observation opening.

The change in color development may be measured visually or by using, for example, a reflection type densitometer.

If measurements are to be made visually, one color change can be achieved by printing multiple color samples and biological information corresponding to each color sample on the surface of the first support opposite to the surface on which the adhesive is applied. Biological information can be easily recognized by visual observation.

(Example 2) In this example, a biological information testing device is manufactured from a first support, a second support, a biological information testing element, etc., which are each cut in advance.

In this embodiment, the biological information testing device is manufactured as follows.

That is, as shown in FIG.
Prepare a support 8 and open the opening 3 in the first support 8.
on surfaces other than nearby surfaces.

Adhesive 4 is provided.

Next, the biological information testing element 10 containing a reagent that develops color by reacting with body fluids is placed over the opening 3 on the surface provided with the adhesive 4.

After that, it has an opening 6 having the same size as the first support 8 and corresponding to the entrance for m-detection provided in the first support, for example, an opening 6 for body fluid collection. The second support body 9 is overlapped so that the observation opening 3 and the body fluid collection opening 6 are aligned, and the opening 3
The adhesive 4 provided on the surface other than the nearby surface is used to attach the first support 8
By bonding and integrating the second support body 9 and the second support body 9, a biological information testing device 11 is obtained.

Note that the materials of the first support and the second support, the synthetic resin layer, the adhesive, the biological information testing element, etc. are the same as those described in Example 1 above.

By this method, a biological information testing tool is manufactured that is easy to handle and allows the results of biological information testing to be confirmed at a glance, even if the opening for body fluid collection and the observation opening are made small.

[Effects of the Invention] According to the method of the present invention, (1) The adhesive does not protrude into the opening for body fluid collection, and the biological information test sample such as saliva is sufficiently supplied to the biological information test element, so that, for example, , it is possible to manufacture a biological information testing device that can be easily tested with simple handling, such as testing by bringing saliva on a finger into contact with the opening for collecting body fluids (2) Inside the opening for observation (3) It is possible to manufacture a biological information testing device that does not allow adhesive to overflow, and allows for the change in color tone of the biological information testing element to be confirmed at a glance. (4) The biological information test sample is always sufficiently supplied to the biological information testing element from the opening for body fluid collection, and the biological information test result can always be clearly confirmed from the observation opening. It is possible to provide a method for manufacturing a biological information testing device that has the following advantages, such as being able to manufacture a biological information testing device in which the area of the opening and the observation opening are reduced in area.

[Brief explanation of the drawing]

FIG. 1 is a partially cutaway perspective view showing an embodiment of the method of the present invention, FIG. 2 is a perspective view showing an example of a biological information testing device manufactured by the method of the present invention, and FIG. FIG. 4 is a sectional view showing an example of a biological information element in a biological information testing device as an example. l...-first support material, 2#...second support material, 3
. . . Opening for observation, 4. Adhesive, 5. Reagent member, 6. Opening for collecting red body fluid, 7. Opening for observation in the first support original fabric. 8: first support, 9: second support, lO: biological information testing element, 11: biological information testing instrument, 12: support member, 13: Reagent layer, 14--Development layer 6

Claims (2)

[Claims] (1) A biological information testing element that tests biological information and shows the test results by changing color tone, with one support having an opening for observation and the other support having an opening for body fluid collection, In the method for manufacturing a biological information testing device sandwiched between the observation opening and the body fluid collection opening, one of the biological information testing devices has an opening that serves as the body fluid collection opening or the observation opening. The original support fabric and the other original support fabric are bonded together using an adhesive provided on the surface of the original support fabric other than the surface near the opening, and the resulting biological information testing device original fabric is individually bonded. A method for manufacturing a biological information testing device, which comprises cutting the device into biological information testing devices. (2) A biological information testing element that tests biological information and shows the test results by changing color tone, with one support having an opening for observation and the other support having an opening for collecting body fluid, In the method for manufacturing a biological information testing device sandwiched between the observation opening and the body fluid collection opening, one of the biological information testing devices has an opening that serves as the body fluid collection opening or the observation opening. A method for producing a biological information testing device, characterized in that the support and the other support are integrally bonded together using an adhesive provided on a surface of the support other than the surface near the opening.