Adhesive for living body and living body sensor

Abstract

The biological adhesive according to the present invention is a biological adhesive to be adhered to a living body, the biological adhesive is adhered to an adherend having a Shore C hardness of 0, and the angle between the surface of the biological adhesive facing the adherend and the adhesion surface of the adherend is 60 degrees. When the adhesive for living bodies is peeled off from the adherend, the peeling adhesive force is 5.0 N / cm or more.

Description

Technical Field

[0001] The present invention relates to a bioadhesive and a biosensor. Background Art

[0002] In medical institutions such as hospitals and clinics, nursing facilities, and at home, wearable biosensors are used to obtain biometric information such as electrocardiogram waveforms, pulse waves, brain waves, and myoelectricity. The biosensor includes a biometric adhesive having adhesive properties provided on the surface facing the biometric surface of a substrate, and biometric electrodes that contact the biometric surface to obtain the biometric information of the subject. When measuring the biometric information, the biometric adhesive is attached to the skin of the subject, and electrical signals related to the biometric information are obtained using the biometric electrodes.

[0003] As such a biosensor bioadhesive, for example, a pressure-sensitive adhesive layer formed of a mixture containing isononyl acrylate (INA), 2-methoxyethyl acrylate (2-MEA) and acrylic acid is disclosed. This pressure-sensitive adhesive layer is attached to the attachment side of the base material layer of the biosensor, and the biosensor is directly attached to the skin when in use (for example, see Patent Document 1).

[0004] Prior art literature

[0005] Patent Literature

[0006] Patent Document 1: Japanese Patent Application Publication No. 2020-163120 Summary of the invention

[0007] Problems to be solved by the invention

[0008] Here, the adhesiveness of the bioadhesive such as the pressure-sensitive adhesive layer of Patent Document 1 is generally evaluated according to JIS Z 0237: 2009. For example, the bioadhesive is attached to a hard test plate such as a phenolic resin plate or a stainless steel plate, and the bioadhesive is peeled off along 180° from the test plate to evaluate the adhesiveness of the bioadhesive to the test plate, so that the best material for the bioadhesive is selected.

[0009] However, the test plate is smooth, rigid, and has no deformation on the surface, but there are many tiny bumps on the surface of the organism, and the shape of the surface of the organism is also easily deformed with body movement. Therefore, the adhesiveness of the adhesive for organisms is easily offset when the adhesive for organisms is attached to the test plate and when it is attached to the surface of the organism, so that even if the adhesive for organisms has excellent adhesion to the test plate, there is a problem that it is possible that the adhesiveness is not fully exhibited on the surface of the organism.

[0010] Biosensors are often used by being attached to a biological surface such as the skin of a subject for a long period of time (e.g., more than 24 hours). Therefore, in order to stably obtain electrical signals related to the biological information of the subject for a long period of time, it is important that the bioadhesive can reliably exhibit adhesion to the biological surface.

[0011] An object of one embodiment of the present invention is to provide an adhesive for a living body that can exhibit excellent adhesion reliability to a living body surface.

[0012] Methods for solving problems

[0013] One embodiment of the present invention is a living body adhesive to be attached to a living body,

[0014] The above-mentioned biological adhesive is adhered to an adherend with a Shore C hardness of 0, the angle between the surface of the above-mentioned biological adhesive facing the above-mentioned adherend and the sticking surface of the above-mentioned adherend is set to 60°, and the peeling adhesion force when the above-mentioned biological adhesive is peeled off from the above-mentioned adherend is greater than 5.0N / cm.

[0015] Effects of the Invention

[0016] One aspect of the present invention can demonstrate excellent adhesion reliability to a biological surface. BRIEF DESCRIPTION OF THE DRAWINGS

[0017] Figure 1 It is a perspective view showing the overall structure of a biosensor to which the living body adhesive according to the embodiment of the present invention is applied.

[0018] Figure 2 It is a plan view showing an example of each component of the biosensor.

[0019] Figure 3 is the cross-sectional view of the biosensor in the length direction, Figure 1 II cross-sectional view.

[0020] Figure 4 To express that Figure 1 An explanatory diagram showing a state in which the biosensor is attached to the chest of a living body.

[0021] Figure 5 The graph shows the measurement results of 60° peeling adhesive force when a human skin gel sheet stored for 3 days under normal temperature and normal humidity conditions (22°C, 50RH%) and high temperature and high humidity conditions (60°C, 90RH%) was used as an adherend.

[0022] Figure 6 This is a graph showing the relationship between the number of peeling times of the biosensors of the respective Examples and Comparative Examples and the 60° peeling strength of the laminated bodies of the bioadhesives used in the respective Examples and Comparative Examples. DETAILED DESCRIPTION

[0023] The following is a detailed description of the embodiments of the present invention. In addition, in order to facilitate the understanding of the description, the same symbols are attached to the same components in each drawing, and repeated descriptions are omitted. In addition, the scales of the components in the drawings are sometimes different from the actual ones. In this specification, "to" indicating a numerical range means that the numerical values ​​recorded before and after it are included as the lower limit and upper limit unless otherwise specified.

[0024] <Biological adhesive>

[0025] The adhesive for organisms involved in this embodiment is described. In addition, the organism refers to the human body (human), as well as animals such as cows, horses, pigs, chickens, dogs and cats. The adhesive for organisms involved in this embodiment can be used as an organism, and is suitable for use in the human body. In this embodiment, as an example, the case where the organism is a human is described.

[0026] The adhesive for organisms involved in the present embodiment is an adhesive for sticking a part of an organism (e.g., skin, scalp, or forehead), and has a sheet shape. The adhesive for organisms involved in the present embodiment can be formed into any shape such as a roughly rectangular, roughly polygonal, roughly circular, or roughly elliptical shape when viewed from above.

[0027] The biological adhesive according to the present embodiment is attached to an adherend having a Shore C hardness of 0, and the biological adhesive according to the present embodiment has a peeling force of 5.0 N / cm or more when peeled from the adherend at a peeling angle of 60° relative to the adherend. The peeling force is preferably 6.5 N / cm or more, and more preferably 7.5 N / cm or more.

[0028] In addition, in this embodiment, the peeling angle refers to the angle between the surface of the biological adhesive facing the adherend and the adhesion surface of the adherend, and refers to the angle between the surface of the biological adhesive facing the adherend before the biological adhesive is peeled off from the adherend and the adhesion surface of the adherend.

[0029] In this embodiment, the peeling force refers to the peeling force (peel strength). The peeling angle is set to 60°, and the peeling force when peeling from the adherend is set to 60° peeling force. When measuring the peeling force, the temperature and humidity can be normal temperature and humidity (for example, 22°C, 50RH%).

[0030] When measuring the peeling adhesive force, the peeling speed when peeling the bioadhesive from the adherend can be appropriately set according to the size and type of the bioadhesive used, and can be, for example, 150 mm / min.

[0031] The inventors of the present application have focused on the fact that when the biological adhesive is attached to the surface of a biological body for use, depending on the peeling angle of the biological adhesive, sometimes a peeling adhesion force that is inconsistent with the peeling adhesion force when the biological adhesive is actually attached to the skin of a subject for use is shown. In addition, the inventors of the present application have found that if the peeling adhesion force (60° peeling adhesion force) of the biological adhesive when the peeling angle relative to the adherend with a Shore C hardness of 0 is set to 60° is 5.0N / cm or more, the deviation of the peeling adhesion force when the biological adhesive is attached to the surface of the subject's skin is actually suppressed, and the required adhesion force of the biological adhesive to the subject's skin can be effectively exerted.

[0032] In many cases, the angle at which the skin of the subject is deformed by physical activities is about 60° or less. If the peeling angle is 60°, the subject can have the maximum angle at which the skin is deformed due to general movements in life. Therefore, the peeling adhesion of the biological adhesive involved in this embodiment relative to the adherend when the peeling angle is set to 60° tends to show a value close to the peeling adhesion of the biological adhesive involved in this embodiment when it is actually attached to the skin of the subject. Therefore, if the biological adhesive involved in this embodiment has a peeling adhesion of more than 5.0N / cm when the peeling angle is set to 60°, it matches the peeling adhesion required when it is actually peeled off from the surface of the subject's skin, and can have a peeling adhesion close to that during actual use, thereby being able to exert excellent bonding reliability to the surface of the skin.

[0033] In addition, the peeling adhesion when the peeling angle of the biological adhesive relative to the adherend with a Shore C hardness of 0 is set to 60° is obtained by pasting the biological adhesive involved in this embodiment to the human skin gel sheet, setting the peeling angle between the human skin gel unilateral surface of each biological adhesive and the human skin gel sheet to 60°, and measuring the peeling adhesion when the biological adhesive involved in this embodiment is peeled off from the human skin gel sheet from the end of the length direction of one side of the biological adhesive involved in this embodiment. In addition, the human skin gel sheet can be used if the Shore C hardness is 0. As the human skin gel sheet, a commercially available product can be used, for example, H0-1 manufactured by Excel Corporation can be used.

[0034] The peeling adhesion of the organism adhesive that the present embodiment is related to can use the laminated body (organism adhesive) that pastes the support of plate shape on the face different from the adherend of the organism adhesive that the present embodiment is related to.Can use the measured value when the organism adhesive that the present embodiment is related to is pasted on the adherend and the laminated body is peeled off from the adherend by the end of the length direction of one side of the laminate.Support can cite for example, polyethylene terephthalate (PET) etc.If support uses PET etc., then more accurately seek the peeling adhesion of organism adhesive.

[0035] The 60° peel adhesion of the adhesive for living organisms involved in this embodiment can be adjusted mainly by the glass transition temperature Tg of the adhesive for living organisms involved in this embodiment as described later, and can further be adjusted by including polymer molecular weight, gel fraction, saturated water content, components contained in the adhesive for living organisms and their contents, etc.

[0036] The reliability of adhesion to the skin surface can be evaluated by performing a tensile durability test or the like.

[0037] When conducting a tensile durability test, for example, a high-performance artificial skin model (trade name: biomask, manufactured by BEAULAX Co., Ltd.) is used as a substitute for skin, and the biosensor formed using the bioadhesive according to the present embodiment is attached and fixed. The biomask attached with the biosensor is placed in a general surface state tensile testing machine such as a small desktop durability testing machine, and is placed in a manner such that the strain of the biomask becomes a predetermined value (for example, 20%), and the extension is repeated once every 3 seconds until the end of the biosensor peels off, and the number of times (number of repetitions) until peeling occurs is studied, thereby conducting an evaluation.

[0038] The glass transition temperature Tg of the adhesive for living organisms involved in this embodiment is preferably above -57°C, more preferably above -57°C, and further preferably above -45°C. If the glass transition temperature Tg of the adhesive for living organisms involved in this embodiment is above -55°C, it is easy to adapt to adherends with a Shore C hardness of 0, such as human skin gel sheets, and can also be adapted and pasted to the skin of the subject. In addition, the upper limit value of the glass transition temperature Tg of the adhesive for living organisms involved in this embodiment is not particularly limited. If it is below -30°C, it can maintain an adapted state to an adherend with a Shore C hardness of 0, and therefore it is easy to maintain an adapted and pasted state like the skin of the subject.

[0039] The molecular weight of the polymer of the biological adhesive according to the present embodiment can be appropriately selected depending on the type of material forming the biological adhesive, and the like, and may be, for example, 500,000 to 1.8 million.

[0040] The gel fraction of the bioadhesive according to the present embodiment is not particularly limited, as long as it is 25% to 65% by mass. If the gel fraction is 25% to 65% by mass, the increase in the peeling adhesive force of the bioadhesive according to the present embodiment over time is suppressed, and the contamination of the surface of the bioadhesive when the bioadhesive according to the present embodiment is peeled off from the surface of the bioadhesive is suppressed, and the peeling operation becomes easy. Therefore, the bioadhesive according to the present embodiment has excellent peelability and operability (operability).

[0041] The saturated water content of the biological adhesive involved in this embodiment can be appropriately selected according to the type of material forming the biological adhesive, for example, at 22°C and RH50%, 0.25% to 0.55% can be set to 40°C and RH92%, and can be 0.50% to 1.3%.

[0042] The living body adhesive according to the present embodiment may have moisture permeability, so that water vapor caused by sweat or the like generated from the skin to which the living body adhesive according to the present embodiment is adhered can escape to the outside through the living body adhesive according to the present embodiment.

[0043] The moisture permeability of the adhesive for living body according to the present embodiment can be, for example, 1 g / (m 2 The moisture permeability of the adhesive for living organisms according to the present embodiment may be 10000 g / (m 2 ·day) or less. If the moisture permeability of the adhesive for biological use is 1g / (m 2 · days) or more, when the living body adhesive is attached to the skin, sweat and the like conducted from the living body adhesive can be transmitted to the outside, thereby reducing the load on the skin.

[0044] As the material for forming the adhesive for organism involved in this embodiment, a material having pressure-sensitive adhesiveness can be used. As the material having pressure-sensitive adhesiveness, for example, acrylic adhesives, silicone adhesives, etc. can be used, and acrylic adhesives are preferably used. As acrylic adhesives, for example, acrylic polymers recorded in Japanese Patent Publication No. 2002-65841 can be cited.

[0045] The bioadhesive according to the present embodiment contains a polymer as a main component, and may contain additives such as a thickener (thickener), a liquid component, and a cross-linking agent as appropriate.

[0046] The polymer used in the living body adhesive according to the present embodiment is not particularly limited, and acrylic polymers, silicone polymers, and the like, which are generally used as pressure-sensitive adhesive polymers for adhesives, can be used, and acrylic polymers are preferably used.

[0047] The acrylic pressure-sensitive adhesive contains an acrylic polymer as a main component, and a polymer obtained by polymerizing a monomer component containing isononyl acrylate, methoxyethyl acrylate and other (meth)acrylates as the main component can be used. The content of the monomer component of the main component is 60% to 99% by mass, and the content of the monomer component of the optional component is 1 to 40% by mass. As the acrylic polymer, for example, the (meth)acrylate resin described in Japanese Patent Publication No. 2003-42541 can be used.

[0048] The content of the polymer can be appropriately selected, and for example, it may be 90 to 120 parts by mass based on 100 parts by mass of the adhesive for living organisms.

[0049] The tackifier is not particularly limited, and a general tackifier can be used, for example, terpene resin, etc. As the tackifier resin, a commercial product can be used, and specifically, Haritac PCJ manufactured by Harima Chemicals Co., Ltd., KE-311 manufactured by Arakawa Chemical Industries, Ltd., etc. can be used.

[0050] The content of the thickener can be appropriately selected, and for example, can be 3 to 30 parts by mass based on 100 parts by mass of the adhesive for use on a living body.

[0051] The liquid component is not particularly limited, and a general liquid component can be used, for example, caprylic acid triglyceride, etc. As the liquid component, a commercially available product can be used, and specifically, Coconard RK manufactured by Kao Corporation, etc. can be used.

[0052] The content of the liquid component can be appropriately selected, and can be, for example, 10 to 20 parts by mass relative to 100 parts by mass of the adhesive for living organisms.

[0053] The crosslinking agent is not particularly limited, and a general crosslinking agent such as an isocyanate crosslinking agent can be used. For example, a polyfunctional isocyanate compound can be used.

[0054] As the polyfunctional isocyanate compound, for example, preferably a compound having at least 2 or more isocyanate groups in the molecule, more preferably 3 or more, but there is no particular limitation, and specifically, aliphatic polyisocyanates, alicyclic polyisocyanates, aromatic polyisocyanates, etc. can be cited. These can be used alone or in combination of two or more.

[0055] Examples of the aliphatic polyisocyanates include tetramethylene diisocyanates such as 1,2-ethylene diisocyanate, 1,2-tetramethylene diisocyanate, 1,3-tetramethylene diisocyanate, and 1,4-tetramethylene diisocyanate; hexamethylene diisocyanates such as 1,2-hexamethylene diisocyanate, 1,3-hexamethylene diisocyanate, 1,4-hexamethylene diisocyanate, 1,5-hexamethylene diisocyanate, 1,6-hexamethylene diisocyanate, and 2,5-hexamethylene diisocyanate; 2-methyl-1,5-pentane diisocyanate, 3-methyl-1,5-pentane diisocyanate; and lysine diisocyanate.

[0056] Examples of the alicyclic polyisocyanates include isophorone diisocyanate, cyclohexyl diisocyanates such as 1,2-cyclohexyl diisocyanate, 1,3-cyclohexyl diisocyanate, and 1,4-cyclohexyl diisocyanate, cyclopentyl diisocyanates such as 1,2-cyclopentyl diisocyanate and 1,3-cyclopentyl diisocyanate, hydrogenated xylylene diisocyanate, hydrogenated toluene diisocyanate, hydrogenated diphenylmethane diisocyanate, hydrogenated tetramethyl diisocyanate, and 4,4′-dihexylmethane diisocyanate.

[0057] Examples of the aromatic polyisocyanates include 2,4-toluene diisocyanate, 2,6-toluene diisocyanate, 4,4'-diphenylmethane diisocyanate, 2,4'-diphenylmethane diisocyanate, 2,2'-diphenylmethane diisocyanate, 4,4'-diphenyl ether diisocyanate, 2-nitrodiphenyl-4,4'-diisocyanate, and 2,2'-diphenylpropane-4,4'-diisocyanate. , 3,3'-dimethyldiphenylmethane-4,4'-diisocyanate, 4,4'-diphenylpropane diisocyanate, m-phenylene diisocyanate, p-phenylene diisocyanate, naphthylene-1,4-diisocyanate, naphthylene-1,5-diisocyanate, 3,3'-dimethoxydiphenyl-4,4'-diisocyanate, xylylene-1,4-diisocyanate, xylylene-1,3-diisocyanate, etc.

[0058] In addition, as the polyfunctional isocyanate compound, aliphatic polyisocyanates, alicyclic polyisocyanates, aromatic polyisocyanates, dimers and trimers of aromatic aliphatic polyisocyanates can be used. Specifically, dimers and trimers of diphenylmethane diisocyanate, reaction products of trimethylolpropane and toluene diisocyanate, reaction products of trimethylolpropane and hexamethylene diisocyanate, polymers of polymethylene polyphenyl isocyanate, polyether polyisocyanate, polyester polyisocyanate, etc. can be cited.

[0059] Examples of the reaction product of trimethylolpropane and tolylene diisocyanate include a trimer adduct of trimethylolpropane and tolylene diisocyanate, and a trimer adduct of trimethylolpropane and hexamethylene diisocyanate.

[0060] As the polyfunctional isocyanate compound, commercially available products can also be used. Specifically, as a trimer adduct of trimethylolpropane and toluene diisocyanate, there can be mentioned a product under the trade name "Colonate L" (manufactured by Nippon Polyurethane Industries, Ltd.), and as a trimer adduct of trimethylolpropane and hexamethylene diisocyanate, there can be mentioned a product under the trade name "Colonate HL" (manufactured by Nippon Polyurethane Industries, Ltd.).

[0061] The content of the crosslinking agent is not particularly limited as long as it is blended so that the bioadhesive according to the present embodiment satisfies predetermined properties such as gel fraction, and may be, for example, 0.050 to 0.20 parts by mass based on 100 parts by mass of the bioadhesive.

[0062] The adhesive for living body according to the present embodiment may be an adhesive tape formed of the above-mentioned material.

[0063] The adhesive for organisms involved in this embodiment can be formed on its surface, and the concave portions with a thickness thinner than other parts (or zero thickness) are repeatedly arranged alternately, and a wave-shaped pattern (net pattern) is formed. As the adhesive for organisms involved in this embodiment, for example, an adhesive tape with a net pattern formed on its surface can be used. The adhesive for organisms involved in this embodiment has a net pattern on its surface, so there are two parts on the surface of the adhesive for organisms involved in this embodiment where the adhesive is easy to contact with the organism and the part that is difficult to contact with the organism, so the surface of the adhesive for organisms involved in this embodiment can be made to be easy to contact with the organism. The moisture permeability of the adhesive for organisms involved in this embodiment is easy to be higher as the adhesive is thinner. Therefore, the adhesive for organisms involved in this embodiment forms a net pattern on its surface, and the thickness of the adhesive has a part that is thin, so compared with the case where the net pattern is not formed, it is possible to maintain the adhesive force while improving the moisture permeability. In addition, the shape of the concave portion can be a straight line or a circular shape in addition to the wave shape.

[0064] The thickness of the biological adhesive according to this embodiment can be set arbitrarily and is preferably 10 μm to 300 μm, and more preferably 50 μm to 100 μm. If the thickness of the first adhesive layer 122 is 10 μm to 300 μm, the biological adhesive according to this embodiment can be made thinner.

[0065] Thus, the adhesive for living body involved in this embodiment can match the actual adhesion of the subject to the surface of the skin 2 by making the 60° peeling adhesion to the adherend with a Shore C hardness of 0 to be 5.0 N / cm or more, and thus has an adhesion close to that in actual use. In addition, the adhesive for living body involved in this embodiment can have an adhesion close to that in actual use to the skin 2 even when the skin 2 is dry, sweat-soaked, or wetted with water such as a shower. Thus, the adhesive for living body involved in this embodiment can exert excellent adhesion reliability to the surface of the skin 2.

[0066] <Biosensor>

[0067] A biosensor to which the bioadhesive according to the present embodiment is applied will be described. Figure 1 As shown, the first adhesive layer 122 of the upper sheet 12 of the biosensor 1 described later is used.

[0068] In this embodiment, the case where the first adhesive layer 122 is used as the bioadhesive according to this embodiment is described. The bioadhesive according to this embodiment can be used as long as it is an adhesive layer provided at a position where the biosensor 1 contacts the biobody. The bioadhesive according to this embodiment can be used for the second adhesive layer 43 of the second layer member 40 of the biosensor 1 described later, and can be used for both the first adhesive layer 122 of the upper sheet 12 and the second adhesive layer 43 of the second layer member 40.

[0069] The biosensor to which the bioadhesive for living organisms according to the present embodiment is applied is a stick-on biosensor that is attached to a part of a living organism (e.g., skin, scalp, or forehead) to measure biometric information. In the present embodiment, a case where the biosensor is attached to human skin to measure an electrical signal (biometric signal) related to the biological information of the human being is described.

[0070] Figure 1 It is a perspective view showing the overall structure of a biosensor to which the living body adhesive according to the present embodiment is applied. Figure 1 The left side shows the appearance of the biosensor. Figure 1 The right side of shows the disassembled state of each component of the biosensor. Figure 2 It is a plan view showing an example of each component of the biosensor. Figure 3 is the cross-sectional view of the biosensor in the length direction, Figure 1 II cross-sectional view.

[0071] Figure 1 and Figure 2As shown, the biosensor 1 is a plate-like (sheet-like) member formed in a substantially elliptical shape in a plan view. Figure 2 and Figure 3 As shown in the figure, the biosensor 1 includes a first layer member 10, an electrode 20, a sensor portion 30, and a second layer member 40, and the first layer member 10, the electrode 20, and the second layer member 40 are stacked in order from the first layer member 10 side toward the second layer member 40 side. In the biosensor 1, the first layer member 10, the electrode 20, and the second layer member 40 form an adhesive surface for skin 2 as an example of a living body. The biosensor 1 adheres the adhesive surface to the skin 2, measures the potential difference (polarization voltage) between the skin 2 and the electrode 20, and thereby measures an electrical signal (biological signal) related to the biological information of the subject.

[0072] Figure 1 to Figure 3 In the present invention, a three-dimensional orthogonal coordinate system with three axes (X-axis, Y-axis, and Z-axis) is used, and the width direction of the biosensor is the X-axis, the length direction is the Y-axis, and the height direction (thickness direction) is the Z-axis. The opposite direction (outer side) of the biosensor 1 pasted on one side (paste side) of the biological body (test object) is set as the +Z-axis, and the pasting side is set as the -Z-axis. In the following description, for the convenience of explanation, the +Z-axis is sometimes set as the upper side or top, and the -Z-axis is set as the lower side or bottom, which does not represent a general up-down relationship.

[0073] In addition, the biological signal is an electrical signal indicating, for example, an electrocardiogram waveform, a brain wave, a pulse, or the like.

[0074] [1st layer components]

[0075] Figure 1 and Figure 2 As shown, the first layer member 10 is provided by sequentially laminating a cover member 11 and an upper sheet 12. The cover member 11 and the upper sheet 12 have substantially the same outer shape in a plan view.

[0076] The first layer member 10 has a rectangular shape having a longitudinal direction (Y-axis direction) and a width direction (X-axis direction) in a plan view, and may have semicircular roundness at both ends in the longitudinal direction.

[0077] (covering member)

[0078] Figure 3 As shown in the figure, the cover member 11 is located at the outermost side (+Z axis direction) of the biosensor 1 and is bonded to the upper surface of the upper sheet 12. The cover member 11 has a central portion in the longitudinal direction (Y axis direction) and has a central portion in the longitudinal direction (Y axis direction). Figure 1The cover member 11 includes a protrusion 111 that protrudes in a substantially hemispherical shape in the height direction (+Z axis direction) of the cover member 11, and flat portions 112A and 112B provided at both end sides in the length direction (Y axis direction) of the cover member 11. The upper and lower surfaces of the protrusion 111 and the upper and lower surfaces of the flat portions 112A and 112B are formed flatly.

[0079] The covering member 11 has an opening formed so as to have a concave pit 111a formed on the inner side (sticking side) of the protruding portion 111. The pit 111a only needs to form at least a part of the storage space S, and at least a part of the sensor unit 30 can be stored therein. On the inner side (sticking side) of the protruding portion 111, the storage space S for storing the sensor unit 30 is formed by the pit 111a on the inner surface of the protruding portion 111, the electrode 20 and the second layer member 40.

[0080] In general, the covering member 11 can be formed using a flexible material such as a cross-linked rubber. As the cross-linked rubber, for example, silicone rubber, fluororubber, urethane rubber, natural rubber, acrylic rubber, butadiene rubber, isoprene rubber, styrene-butadiene copolymer rubber, nitrile rubber, hydrogenated nitrile rubber, chloroprene rubber, ethylene-propylene copolymer rubber, chlorinated polyethylene rubber, chlorosulfonated polyethylene rubber, butyl rubber and halogenated butyl rubber can be cited. In addition, the covering member 11 can be formed by using a base resin such as polyethylene terephthalate (PET) as a support and laminating the above-mentioned flexible material on the surface of the support. By forming the covering member 11 using the above-mentioned flexible material, the sensor part 30 configured in the storage space S of the covering member 11 is protected, and the impact applied to the biosensor 1 from the upper side is absorbed and the impact applied to the sensor part 30 is mitigated.

[0081] The thickness of the top and side walls of the protrusion 111 may be thicker than the thickness of the flat portions 112A and 112B. This can reduce the flexibility of the protrusion 111 compared to the flexibility of the flat portions 112A and 112B, and protect the sensor unit 30 from external forces applied to the biosensor 1.

[0082] The thickness of the top surface and the side wall of the protrusion 111 can be appropriately designed, for example, 1.5 mm to 3 mm. The thickness of the flat portions 112A and 112B can also be appropriately designed, for example, 0.5 mm to 1 mm.

[0083] The thin flat portions 112A and 112B are more flexible than the protruding portion 111, so when the biosensor 1 is attached to the skin 2, it is easy to deform to follow the deformation of the surface of the skin 2 caused by body movements such as stretching, bending, and twisting. Therefore, when the surface of the skin 2 is deformed, the stress applied to the flat portions 112A and 112B can be alleviated, and the biosensor 1 can be difficult to peel off from the skin 2.

[0084] The outer periphery of the flat portions 112A and 112B may have a shape in which the thickness gradually decreases toward the ends. This can further improve the flexibility of the outer periphery of the flat portions 112A and 112B, and can improve the sense of installation when the biosensor 1 is attached to the skin 2, compared with a case where the thickness of the outer periphery of the flat portions 112A and 112B is not reduced.

[0085] The hardness (strength) of the covering member 11 can be designed to be an appropriate arbitrary size, for example, it can be 40 to 70. If the hardness of the covering member 11 is within the above preferred range, when the skin 2 is stretched by body movement, the upper sheet 12, the electrode 20 and the second layer member 40 can be easily deformed with the movement of the skin 2 without being affected by the covering member 11. In addition, the hardness (hardness) refers to the Shore A hardness. In this specification, the Shore A hardness refers to the value measured in accordance with ISO7619-1 (JIS K 6253-3: 2012). The Shore A hardness is the A-type durometer hardness measured by a rubber durometer (A-type durometer) with an A-type (cylindrical) indenter. As described in JIS K 6253-3:2012 “Rubber, vulcanized and thermoplastic rubber - Method for determining hardness - Part 3: Durometer hardness”, the measured value of the type A durometer hardness obtained by preparing a sheet sample of a predetermined size using the covering member 11 and measuring the same can be regarded as the Shore A hardness of the covering member 11 .

[0086] (Upper piece)

[0087] Figure 3 As shown in the figure, the upper sheet 12 is bonded to the lower surface of the covering member 11 and is provided. The upper sheet 12 contains the above-mentioned adhesive for living organisms involved in this embodiment. The upper sheet 12 has a through hole 12a at a position opposite to the protrusion 111 of the covering member 11. The sensor body 32 of the sensor part 30 is not blocked by the upper sheet 12 and can be accommodated in the storage space S formed by the recess 111a on the inner surface of the covering member 11 and the through hole 12a.

[0088] The upper sheet 12 includes a first substrate 121 , a first adhesive layer 122 having the electrode 20 adhered to a surface of the first substrate 121 facing the electrode 20 , and an upper adhesive layer 123 provided on a surface opposite to the surface of the first substrate 121 facing the electrode 20 .

[0089] ((First base material))

[0090] Figure 3 As shown, the first base material 121 is provided on the pasting side which is the opening side of the cover member 11 . Figure 1 As shown in FIG. 1 , the first substrate 121 is formed in a sheet shape. The first substrate 121 may have flexibility, water resistance, and moisture permeability. Since the first substrate 121 has flexibility, water resistance, and moisture permeability, the first substrate 121 is easily extended in a state of contact with the skin 2, and can maintain a state of contact with the skin 2, and can suppress the intrusion of liquid into the gap between the first substrate 121 and the upper adhesive layer 123. In addition, water vapor generated by sweat generated by the skin 2 can be released to the outside of the biosensor 1 through the first substrate 121. Therefore, the upper sheet 12 is easy to maintain adhesion durability.

[0091] The first substrate 121 may be a non-porous body without a porous structure or a porous body with a porous structure if it has flexibility, waterproofness, and moisture permeability. If the first substrate 121 is a non-porous body, it is easy to maintain the thin film and strength of the first substrate 121, so it is preferred. If the first substrate 121 is a porous body, it is easy to release water vapor brought by sweat generated by the skin 2 to which the biosensor 1 is attached to the first substrate 121 to the outside of the biosensor 1, so it is preferred.

[0092] As the non-porous body, a molded body formed in a sheet shape can be used.

[0093] As porous body, can have the bubble structure of continuous bubble, independent bubble, semi-independent bubble etc.That is, porous body can be the porous body (porous body with connected bubble structure) manufactured by the foam molding forming connected bubble, can be the porous body (porous body with independent bubble structure) manufactured by the foam molding forming independent bubble, can be the porous body (porous body with independent bubble structure) manufactured by the foam molding forming semi-independent bubble.Among these, from bringing into play higher waterproofness, seek the aspect of filmization and the maintenance of intensity, preferably the porous body with independent bubble structure.As porous body, for example, can use foam sheet, nonwoven fabric sheet etc.

[0094] As a material forming the first substrate 121, for example, a flexible material such as a thermoplastic resin such as a polyurethane resin, a polystyrene resin, a polyolefin resin, a silicone resin, an acrylic resin, a vinyl chloride resin, or a polyester resin, or a thermoplastic elastomer can be used.

[0095] As thermoplastic elastomer, polyurethane thermoplastic elastomer, polystyrene thermoplastic elastomer, polyolefin thermoplastic elastomer, polyester thermoplastic elastomer, polyvinyl chloride thermoplastic elastomer, polyamide thermoplastic elastomer, nitrile thermoplastic elastomer, nylon thermoplastic elastomer, fluororubber thermoplastic elastomer, polybutadiene thermoplastic elastomer, ethylene vinyl acetate thermoplastic elastomer, chlorinated polyethylene thermoplastic elastomer, styrene-butadiene block copolymer or its hydride, styrene-isoprene block copolymer or its hydride etc. can be enumerated. They can be used alone or in combination of two or more. Among these, polyurethane thermoplastic elastomer is preferred.

[0096] When the first substrate 121 is a non-porous body, specifically, a polyurethane sheet such as S-URS manufactured by Nippon Matai can be used.

[0097] When the first substrate 121 is a porous body, specifically, a foam sheet such as FOLEC manufactured by INOAC CORPORATION, a nonwoven fabric sheet such as medical adhesive base cloth EW manufactured by Nippon Vilene, etc. can be used.

[0098] The moisture permeability of the first substrate 121 may be higher than that of the cover member 11. The moisture permeability of the first substrate 121 may be 100 g / (m 2 ·day)~5000g / (m 2 ·day). If the moisture permeability of the first substrate 121 is 100g / (m 2 ·day)~5000g / (m 2 ·day), the first substrate 121 can allow the water vapor that penetrates from one side to pass through the first substrate 121 and be stably released from the other side.

[0099] The thickness of the first substrate 121 can be appropriately set according to the type of the first substrate 121, etc., and is preferably thicker than the thickness of the flat portions 112A and 112B of the cover member 11. If the thickness of the first substrate 121 is thicker than the thickness of the flat portions 112A and 112B of the cover member 11, it is possible to reduce irritation caused by the flat portions 112A and 112B of the cover member 11 contacting the skin 2. The thickness of the first substrate 121 can be, for example, 10 μm to 1.5 mm.

[0100] When the first substrate 121 is formed of a porous body such as a foam sheet or a nonwoven fabric sheet, the thickness of the first substrate 121 is, for example, preferably 0.5 mm to 1.5 mm, more preferably about 1 mm.

[0101] When the first substrate 121 is formed of a non-porous body such as a polyurethane sheet, the thickness of the first substrate 121 is, for example, preferably 10 μm to 300 μm, and more preferably about 30 μm.

[0102] The first base material 121 has a through hole 121a at a position facing the protruding portion 111 of the cover member 11. By providing the first adhesive layer 122 and the upper adhesive layer 123 on the surface other than the through hole 121a of the first base material 121, through holes 122a and 123a can be formed in the first adhesive layer 122 and the upper adhesive layer 123. The through holes 121a, 122a, and 123a form the through hole 12a.

[0103] ((First adhesive layer))

[0104] Figure 3 As shown in the figure, the first adhesive layer 122 is provided in a state of being adhered to the surface of the first substrate 121 that is opposite to the electrode 20. The first adhesive layer 122 uses the above-mentioned adhesive for living body involved in this embodiment. The first adhesive layer 122 is located on the surface of the living body side (-Z axial direction) of the first substrate 121, and has the function of bonding the skin 2 to the first substrate 121, the function of bonding the first substrate 121 to the second substrate 41, and the function of bonding the first substrate 121 to the electrode 20.

[0105] The first adhesive layer 122 is attached to an adherend having a Shore C hardness of 0, and when the peeling angle of the first adhesive layer 122 relative to the adherend is set to 60 °, it has a peeling adhesion of more than 5.0N / cm when peeled from the adherend. The peeling adhesion is preferably more than 6.5N / cm, more preferably more than 7.5N / cm. The peeling adhesion of the first adhesive layer 122 relative to the adherend when the peeling angle is 60 ° has a tendency to show a value close to the peeling adhesion that the first adhesive layer 122 actually has when it is attached to the skin 2. Thus, if the first adhesive layer 122 has a peeling adhesion of more than 5.0N / cm when the peeling angle is set to 60 °, it can have a peeling adhesion close to the peeling adhesion required when actually peeling from the surface of the subject's skin 2, thereby being able to exert excellent bonding reliability relative to the surface of the skin 2.

[0106] In addition, the peeling adhesive force of the first adhesive layer 122 when the peeling angle with respect to the adherend having a Shore C hardness of 0 is set to 60° is obtained by attaching the first adhesive layer 122 to the human skin gel sheet, setting the peeling angle between the human skin gel surface of the first adhesive layer 122 and the human skin gel sheet to 60°, and measuring the peeling adhesive force when the first adhesive layer 122 is peeled off from the human skin gel sheet. In addition, as the human skin gel sheet, a commercially available product or the like can be used as described above.

[0107] The reliability of adhesion to the surface of the skin 2 can be evaluated by performing a tensile durability test or the like as described above.

[0108] As the support, PET or the like can be used as described above.

[0109] As described above, the glass transition temperature Tg of the first adhesive layer 122 is preferably above -57°C, more preferably above -57°C, and further preferably above -45°C. If the glass transition temperature Tg of the first adhesive layer 122 is above -57°C, as described above, it is easy to adapt to an adherend with a Shore C hardness of 0, and can maintain a state of adhesion that is also adapted to the subject's skin 2. In addition, the upper limit value of the glass transition temperature Tg of the first adhesive layer 122 is not particularly limited, as long as it is below -30°C. If the glass transition temperature Tg of the first adhesive layer 122 is below -30°C, as described above, the first adhesive layer 122 can maintain a state of adaptation relative to an adherend with a Shore C hardness of 0, and can therefore be adhered in a similar manner to the subject's skin.

[0110] As described above, the molecular weight of the polymer of the first adhesive layer 122 can be appropriately selected according to the type of material forming the first adhesive layer 122 and the like, and may be, for example, 500,000 to 1.8 million.

[0111] The gel fraction of the first adhesive layer 122 is not particularly limited, and may be 25% to 65% by mass as described above. When the gel fraction is 25% to 65% by mass, the first adhesive layer 122 can exhibit excellent releasability and handling properties.

[0112] The saturated water content of the first adhesive layer 122 can be appropriately selected according to the type of material forming the first adhesive layer 122, for example, at 22°C and RH50%, it can be set to 0.25% to 0.55%, and at 40°C and RH92%, it can be set to 0.50% to 1.3%.

[0113] As described above, the first adhesive layer 122 may have moisture permeability. As described below, water vapor caused by sweat or the like generated by the skin 2 to which the biosensor 1 is attached can escape to the first substrate 121 through the first adhesive layer 122, and be released from the first substrate 121 to the outside of the biosensor 1. When the first substrate 121 has a bubble structure as described above, water vapor can be released to the outside of the biosensor 1 through the first adhesive layer 122. As a result, it is possible to suppress sweat or water vapor from being retained at the interface between the skin 2 to which the biosensor 1 is attached and the first layer member 10. As a result, the moisture retained at the interface between the skin 2 and the first adhesive layer 122 weakens the adhesive force of the first adhesive layer 122, and it is possible to suppress the biosensor 1 from peeling off from the skin 2.

[0114] The moisture permeability of the first adhesive layer 122 is preferably, for example, 1 g / (m 2 The moisture permeability of the first adhesive layer 122 can be 10000 g / (m 2 If the moisture permeability of the first adhesive layer 122 is 1g / (m 2 · days) or more, when the first adhesive layer 122 is attached to the skin 2, sweat and the like conducted from the first adhesive layer 122 can be transmitted to the outside, thereby reducing the load on the skin 2.

[0115] The material forming the first adhesive layer 122 can be a material having pressure-sensitive adhesive properties as described above, including a polymer as a main component, and can appropriately contain additives such as a tackifier (tackifier), a liquid component, and a cross-linking agent. The material forming the first adhesive layer 122 uses the material for forming an adhesive for a living body involved in the above-mentioned present embodiment, so the details are omitted.

[0116] As described above, the first adhesive layer 122 may be an adhesive tape formed of the above-mentioned material.

[0117] As described above, the first adhesive layer 122 can be formed with a wave-shaped pattern (reticular pattern) formed by repeatedly and alternately arranging concave portions thinner than other portions (or having a thickness of zero) on its surface. As the first adhesive layer 122, for example, an adhesive tape having a reticular pattern formed on its surface can be used. The first adhesive layer 122 has a reticular pattern on its surface, so there are both portions on the surface of the first adhesive layer 122 where the adhesive is easy to contact with the organism and portions that are difficult to contact with the organism, so that the portions on the surface of the first adhesive layer 122 where the adhesive is easy to contact with the organism can be located. The moisture permeability of the first adhesive layer 122 is easier to become higher as the first adhesive layer 122 is thinner. Therefore, the first adhesive layer 122 forms a reticular pattern on its surface, and has a portion where the thickness of the first adhesive layer 122 is partially thin, so that compared with the case where the reticular pattern is not formed, it is possible to maintain the adhesive force while improving the moisture permeability.

[0118] The thickness of the first adhesive layer 122 can be set arbitrarily and is, for example, preferably 10 μm to 300 μm, more preferably 50 μm to 100 μm. When the thickness of the first adhesive layer 122 is 10 μm to 300 μm, the biosensor 1 can be made thinner.

[0119] ((Adhesive layer for the upper part))

[0120] Figure 3As shown in the figure, the upper adhesive layer 123 is provided in a state of being attached to the surface opposite to the surface of the first substrate 121 that faces the electrode 20. The upper adhesive layer 123 is attached to a position corresponding to the flat surface of the attachment side (-Z axial direction) of the cover member 11 on the upper surface of the first substrate 121, and has the function of bonding the first substrate 121 and the cover member 11.

[0121] A biocompatible material is used as a material for forming the upper adhesive layer 123. As the biocompatible material, for example, an acrylic adhesive, a silicone adhesive, a silicone tape, etc. can be used, and a silicone adhesive is preferably used.

[0122] The thickness of the upper adhesive layer 123 can be appropriately set, and may be, for example, 10 μm to 300 μm.

[0123] [electrode]

[0124] Figure 3 As shown in FIG. 1 , the electrode 20 is attached to the skin 2 by connecting a portion of the sensor body 32 side of the electrode 20 to the wiring 331A and 331B below the surface of the attachment side (-Z axis direction) of the first adhesive layer 122, and sandwiching the first adhesive layer 122 and the lower adhesive layer 42. The portion of the electrode 20 that is not sandwiched between the first adhesive layer 122 and the lower adhesive layer 42 is in contact with the biological body. When the biosensor 1 is attached to the skin 2, the electrode 20 is in contact with the skin 2, thereby being able to detect a biological signal. In addition, the electrode 20 can be buried in a state where it is exposed so that the second substrate 41 can contact the skin 2.

[0125] The electrode 20 may be provided so as to be located below a region including the flat portions 112A and 112B when the biosensor 1 is viewed from above.

[0126] The electrode 20 is composed of a pair of electrodes 20A and 20B. Figure 3 As shown in the figure, the electrode 20A is arranged on the left side in the figure, and the electrode 20B is arranged on the right side in the figure. The electrode 20A contacts the terminal portion 332A at one end side (inner side) in the length direction (Y-axis direction), and the electrode 20B contacts the terminal portion 332B at one end side (inner side) in the length direction (Y-axis direction). The pair of electrodes 20A and 20B have substantially the same shape.

[0127] In addition, one end side of the electrode 20A in contact with the terminal portion 332A of the sensor portion 30 is set as the opposing portion 201A, and one end side of the electrode 20B in contact with the terminal portion 332B of the sensor portion 30 is set as the opposing portion 201B. The portion of the electrode 20A that is not in contact with the terminal portion 332A (the other end side (outer side) in the length direction (Y-axis direction)) is set as the exposed portion 202A, and the portion of the electrode 20B that is not in contact with the terminal portion 332B (the other end side (outer side) in the length direction (Y-axis direction)) is set as the exposed portion 202B.

[0128] The electrode 20 may have any shape such as a sheet.

[0129] The shape of the electrode 20 when viewed from above is not particularly limited, and can be designed to any appropriate shape depending on the application, etc. The electrodes 20A and 20B are each as shown in FIG. Figure 2 As shown, in a plan view, the facing portions 201A and 201B on one end side may be formed in a rectangular shape, and the exposed portions 202A and 202B on the other end side may be formed in an arc shape.

[0130] Electrodes 20A and 20B are as follows Figure 2 and Figure 3 As shown in FIG. 1 , the electrode 20 may have through holes 203A and 203B which are elongated in the width direction (X-axis direction) and are arranged at one end side (inner side) in the length direction (Y-axis direction), and through holes 204A and 204B which are circular in shape and are arranged at the other end side (outer side) in the length direction (Y-axis direction). Thus, the electrode 20 can be exposed to the pasting side from the through holes 203A and 203B, and the through holes 204A and 204B in a state of being pasted to the first adhesive layer 122, thereby improving the adhesion between the electrode 20 and the skin 2. In addition, the number of through holes 203A and 203B, and through holes 204A and 204B is not particularly limited, and can be appropriately set according to the size of the opposing parts 201A and 201B of the electrode 20.

[0131] The electrode 20 can be formed using a cured product of a conductive composition containing a conductive polymer and a binder resin, a metal, an alloy, etc. Among them, from the perspective of the safety of the organism, such as no allergic reaction occurs when the electrode 20 is applied to the organism, the electrode 20 is preferably formed using a cured product of the conductive composition. The electrode 20 can be formed using an electrode sheet formed of a cured product of the conductive composition in a sheet shape.

[0132] As conductive polymers, for example, polythiophene conductive polymers, polyaniline conductive polymers, polyacetylene conductive polymers, polypyrrole conductive polymers, polyphenylene conductive polymers and derivatives thereof, and complexes thereof, etc. can be used. These can be used alone or in combination of two or more. Among these, it is preferred to use a complex in which polythiophene is doped with polyaniline as a dopant. Among the complexes of polythiophene and polyaniline, from the perspective of lower contact impedance with a biological body and high conductivity, it is more preferred to use PEDOT / PSS in which polystyrene sulfonic acid (poly-4-styrene sulfonate; PSS) as polyaniline is doped in poly (3,4-ethylenedioxythiophene) (also referred to as PEDOT) as polythiophene.

[0133] The binder resin may be a water-soluble polymer or a water-insoluble polymer. As the water-soluble polymer, a polymer containing a hydroxyl group such as polyvinyl alcohol (PVA) and modified PVA may be used.

[0134] The conductive composition may contain various common additives such as a crosslinking agent and a plasticizer in an appropriate and arbitrary ratio. Examples of the crosslinking agent include aldehyde compounds such as sodium glyoxylate. Examples of the plasticizer include glycerin, ethylene glycol, propylene glycol, and the like.

[0135] As the metal and the alloy, general metals and alloys such as Au, Pt, Ag, Cu, and Al can be used.

[0136] The thickness of the electrode 20 can be set to any appropriate height, for example, 10 μm to 100 μm. If the thickness of the electrode 20 is within the above preferred range, the electrode 20 can have sufficient strength and flexibility, and conductive stability when deformed.

[0137] In addition, the thickness of the electrode 20 refers to the length in the direction perpendicular to the surface of the electrode 20, similarly to the protrusion 111. The thickness of the electrode 20 can be measured in the same manner as the protrusion 111.

[0138] The area of ​​the electrode 20 can be set to any appropriate size according to the size of the biosensor 1, for example, 2.0 cm 2 ~5.0cm 2 If the area of ​​electrode 20 is 2.0 cm 2 ~5.0cm 2 , the electrode 20 can have sufficient conductive stability. In addition, the method for measuring the area of ​​the electrode 20 is not particularly limited, and a general measurement method such as calculation from a plan view image of the electrode can be used.

[0139] (Sensor part)

[0140] Figure 2As shown, the sensor section 30 includes a flexible substrate 31 , a sensor body 32 , and connection sections 33A and 33B connected to the sensor body 32 .

[0141] The flexible substrate 31 is a resin substrate on which various components for acquiring biological information are mounted, and the flexible substrate 31 is provided with a sensor body 32 and connection parts 33A and 33B.

[0142] Figure 2 As shown, the sensor body 32 includes a component mounting portion 321 and a battery mounting portion 322 as a control portion, and acquires biological information.

[0143] The component mounting section 321 includes a CPU and an integrated circuit that processes a biological signal obtained from a living body to generate biological signal data, a switch SW that activates the biological sensor 1, a flash memory that stores biological signals, and various components mounted on the flexible substrate 31 such as a light emitting element, and obtains biological information. In addition, examples of circuits including various components are omitted. The component mounting section 321 operates by power supplied by the battery 34 installed in the battery installation section 322.

[0144] The component mounting unit 321 transmits the information to an external device such as an operation confirmation device that confirms the initial operation or a reading device that reads the biological information from the biosensor 1 by wire or wirelessly.

[0145] The battery mounting portion 322 is disposed between the connection portion 33A and the component mounting portion 321, and supplies power to the integrated circuit and the like mounted on the component mounting portion 321. Figure 2 As shown, a battery 34 is installed.

[0146] The connecting parts 33A and 33B have: wirings 331A and 331B respectively connected to the sensor body 32 in the length direction (Y-axis direction) of the sensor body 32, and terminal parts 332A and 332B arranged on the front end side of the wirings 331A and 331B and connected to the electrode 20.

[0147] One end of the wiring 331A and 331B is as follows Figure 3 As shown, each is connected to an electrode 20 . Figure 3 As shown, the other end of the wiring 331A is connected to the switch SW etc. mounted on the component mounting portion 321 along the outer circumference of the sensor body 32. The other end of the wiring 331B is connected to the switch SW etc. mounted on the component mounting portion 321.

[0148] The terminals 332A and 332B are connected to the wirings 331A and 331B at one end and are disposed in a state of being sandwiched between the first layer member 10 and the second layer member 40 while the top surfaces of the other ends are in contact with the electrode 20 .

[0149] The connecting parts 33A and 33B are as follows Figure 4 As shown in FIG. 1 , the flat portions 112A and 112B may be formed below the flat portions 112A and 112B in a plan view of the biosensor 1 .

[0150] A known battery can be used as the battery 34. As the battery 34, for example, a button-type battery such as CR2025 can be used.

[0151] [Layer 2 components]

[0152] Figure 3 As shown, the second layer member 40 is provided on the attachment surface side of the electrode 20 and the sensor section 30 , is a support substrate on which the sensor section 30 is provided, and forms a part of the attachment surface to the skin 2 . Figure 1 and Figure 2 As shown, the outer shape of both sides of the width direction (X-axis direction) of the second layer member 40 can be substantially the same as the outer shape of both sides of the width direction (X-axis direction) of the first layer member 10. The length (Y-axis direction) of the second layer member 40 is formed shorter than the length (Y-axis direction) of the covering member 11 and the upper sheet 12. Figure 3 As shown, both ends of the second layer member 40 in the longitudinal direction are located so as to sandwich the wirings 331A and 331B of the sensor unit 30 between the second layer member 40 and the upper sheet 12 , that is, to overlap with a part of the electrode 20 .

[0153] The second layer member 40 includes a second base material 41, a lower adhesive layer 42 provided on the upper surface of the second base material 41, and a second adhesive layer 43 provided on the lower surface of the second base material 41. The second base material 41, the lower adhesive layer 42, and the second adhesive layer 43 may be formed in the same shape when viewed from above. The second adhesive layer 43 of the second layer member 40 and the electrode 20 form an adhesive surface for the skin 2. The waterproofness and moisture permeability are different according to the area of ​​the electrode 20 and the second adhesive layer 43, and the adhesiveness can be made different. Thus, the waterproofness and moisture permeability can be made different according to the area of ​​the adhesive surface of the second adhesive layer 43, and the adhesiveness can be made different.

[0154] (Second base material)

[0155] The second base material 41 can be formed using a flexible resin having appropriate stretchability, flexibility, and toughness. As the material forming the second substrate 41, for example, polyester resins such as polyethylene terephthalate (PET), polybutylene terephthalate, polyethylene terephthalate, polyethylene naphthalate, and polybutylene naphthalate; acrylic resins such as polyacrylic acid, polymethacrylic acid, polymethyl acrylate, polymethyl methacrylate (PMMA), polyethyl methacrylate, and polybutyl acrylate; polyolefin resins such as polyethylene and polypropylene; polystyrene resins such as polystyrene, imide-modified polystyrene, acrylonitrile-butadiene-styrene (ABS) resin, imide-modified ABS resin, styrene-acrylonitrile copolymer (SAN) resin, and acrylonitrile-ethylene-propylene-diene-styrene (AES) resin; polyimide resin; polyurethane resin; silicone resin; polyvinyl chloride resins such as polyvinyl chloride and ethylene-vinyl acetate copolymer resin, and the like can be used. Among these, polyolefin resins and PET are preferably used. These thermoplastic resins have water-repellent properties (low water permeability) that prevent water and water vapor from penetrating. Therefore, the second substrate 41 is formed using these thermoplastic resins, so that sweat or water vapor generated by the skin 2 of the living body can be prevented from passing through the second substrate 41 and invading the flexible substrate 31 side of the sensor unit 30 when the biosensor 1 is attached to the skin 2 of the living body.

[0156] The second base material 41 is preferably formed in a flat plate shape because the sensor section 30 is provided on the upper surface thereof via the lower adhesive layer 42 .

[0157] The thickness of the second substrate 41 can be appropriately and arbitrarily selected, and can be, for example, 1 μm to 300 μm.

[0158] (Adhesive layer at the bottom)

[0159] Figure 3 As shown, the lower adhesive layer 42 is arranged on the upper side of the covering member 11 side (+Z axial direction) of the second substrate 41, and the sensor part 30 is bonded. The two end sides of the lower adhesive layer 42 of the second layer member 40 in the length direction are arranged at positions opposite to the opposing parts 201A and 201B of the electrode 20. As a result, the opposing parts 201A and 201B of the electrode 20 can be sandwiched between the upper sheet 12 and the second layer member 40 in a state where the terminal parts 332A and 332B are pushed, and the electrode 20 can be connected to the terminal parts 332A and 332B. The lower adhesive layer 42 can use the same material as the second adhesive layer 43 described later, so the details are omitted. In addition, the lower adhesive layer 42 does not need to be provided and can be omitted.

[0160] (Second adhesive layer)

[0161] Figure 3 As shown, the second adhesive layer 43 is provided on the lower surface of the sticking side (-Z axis direction) of the second base material 41 and is a layer in contact with the living body.

[0162] The second adhesive layer 43 preferably has pressure-sensitive adhesiveness. Since the second adhesive layer 43 has pressure-sensitive adhesiveness, the biosensor 1 can be easily attached to the skin 2 by being pressed against the skin 2 of a living body.

[0163] The material of the second adhesive layer 43 is not particularly limited as long as it is a material having pressure-sensitive adhesive properties, and materials having biocompatibility can be cited. As the material forming the second adhesive layer 43, acrylic pressure-sensitive adhesives, silicone pressure-sensitive adhesives, etc. can be cited. Preferably, acrylic pressure-sensitive adhesives can be cited.

[0164] The acrylic pressure-sensitive adhesive preferably contains an acrylic polymer as a main component. The acrylic polymer can function as a pressure-sensitive adhesive component. As the acrylic polymer, a polymer obtained by polymerizing a (meth)acrylate containing isononyl acrylate, methoxyethyl acrylate, etc. as a main component and a monomer copolymerizable with a (meth)acrylate such as acrylic acid as an arbitrary component can be used.

[0165] The acrylic pressure-sensitive adhesive preferably further contains a carboxylate. The carboxylate acts as a pressure-sensitive adhesive force regulator that reduces the pressure-sensitive adhesive force of the acrylic polymer and adjusts the pressure-sensitive adhesive force of the second adhesive layer 43. The carboxylate can be a carboxylate that is compatible with the acrylic polymer. As the carboxylate, triglycerides and the like can be used.

[0166] Acrylic pressure-sensitive adhesive can contain a cross-linking agent as required. The cross-linking agent is a cross-linking component that cross-links an acrylic polymer. As the cross-linking agent, polyisocyanate compounds (multifunctional isocyanate compounds), epoxy compounds, melamine compounds, peroxide compounds, urea compounds, metal alkoxide compounds, metal chelates, metal salt compounds, carbodiimide compounds, oxazoline compounds, aziridine compounds, amine compounds, etc. can be cited. Among these, polyisocyanate compounds are preferably used. These cross-linking agents can be used alone or in combination.

[0167] The second adhesive layer 43 preferably has excellent biocompatibility. For example, when the second adhesive layer 43 is subjected to a keratin peeling test, the keratin peeling area ratio is preferably 0% to 50%. If the keratin peeling area ratio is within the range of 0% to 50%, even if the second adhesive layer 43 is attached to the skin 2, the load on the skin 2 can be suppressed.

[0168] The second adhesive layer 43 preferably has moisture permeability. Water vapor and the like generated by the skin 2 to which the biosensor 1 is attached can escape to the upper sheet 12 side through the second adhesive layer 43. In addition, as described later, the upper sheet 12 has a bubble structure, so that water vapor can be released to the outside of the biosensor 1 through the second adhesive layer 43. As a result, it is possible to suppress the retention of sweat or water vapor at the interface between the skin 2 to which the biosensor 1 is attached and the second adhesive layer 43. As a result, the moisture accumulated at the interface between the skin 2 and the second adhesive layer 43 weakens the adhesive force of the second adhesive layer 43, and it is possible to suppress the biosensor 1 from peeling off from the skin.

[0169] The moisture permeability of the second adhesive layer 43 can be, for example, 300 g / (m 2 ·day)~10000g / (m 2 When the moisture permeability of the second adhesive layer 43 is within the above range, even when the second adhesive layer 43 is attached to the skin 2, sweat generated from the skin 2 can be appropriately transmitted from the second adhesive layer 43 to the outside, thereby reducing the burden on the skin 2.

[0170] The thickness of the second adhesive layer 43 can be appropriately selected and may be 10 μm to 300 μm. When the thickness of the second adhesive layer 43 is within the above range, the biosensor 1 can be made thinner.

[0171] Figure 1 and Figure 2 As shown in the figure, when the biosensor 1 is not in use, the electrode 20 and the second layer member 40 are protected on the biosensor's attachment surface between the electrode 20 and the second substrate 41. Therefore, it is preferable to attach a release liner 50 until use. When in use, the release liner 50 is peeled off from the electrode 20 and the second layer member 40, and the attachment surface of the biosensor 1 is attached to the skin 2. By attaching the release liner 50 to the attachment surface, the adhesion between the electrode 20 and the second layer member 40 can be maintained even if the biosensor 1 is stored for a long time. Therefore, by peeling the release liner 50 from the second layer member 40 and the electrode 20 when in use, the attachment surface can be securely attached to the skin 2 for use.

[0172] The method for producing the biosensor 1 is not particularly limited, and the biosensor 1 can be produced using any appropriate method. An example of a method for producing the biosensor 1 will be described.

[0173] Prepare Figure 1 and Figure 2 The first layer member 10, the electrode 20, the sensor portion 30 and the second layer member 40 are shown. The first layer member 10, the electrode 20, the sensor portion 30 and the second layer member 40 are not particularly limited as long as the method for manufacturing them can be used, and can be manufactured using any appropriate manufacturing method.

[0174] Prepare to pose Figure 1 After the first layer member 10, the electrode 20, the sensor portion 30 and the second layer member 40 of the biosensor 1 shown in the figure are stacked, the sensor portion 30 is placed on the second layer member 40. Then, from the first layer member 10 side toward the second layer member 40 side, the first layer member 10, the electrode 20, the sensor portion 30 and the second layer member 40 are stacked in order. Thus, a Figure 1 The biosensor 1 is shown.

[0175] Figure 4 To express that Figure 1 1 is an explanatory diagram showing a state where the biosensor 1 is attached to the chest of a subject P. Figure 4 As shown, for example, the biosensor 1 is placed on the sternum of the subject P in the longitudinal direction (Y-axis direction), with one electrode 20 on the upper side and the other electrode 20 on the lower side, and is attached to the skin of the subject P. The biosensor 1 is formed by using Figure 2 The second adhesive layer 43 is adhered to the skin of the subject P, so that the electrode 20 is pressed against the skin of the subject P, and a biological signal such as an electrocardiogram signal is obtained from the subject P through the electrode 20. The biosensor 1 stores the obtained biological signal data in a non-volatile memory such as a flash memory mounted on the component mounting portion 321.

[0176] Thus, the biosensor 1 includes the first layer member 10, the electrode 20, and the sensor body 32, and the first layer member 10 can include the upper sheet 12. The upper sheet 12 includes the bioadhesive according to the present embodiment, and has an adhesive force close to that in actual use, so that it can exhibit excellent adhesive reliability with respect to the surface of the skin 2. The biosensor 1 can stably adhere the upper sheet 12 to the skin 2, and the electrode 20 can contact the surface of the skin 2 in a state of being adhered to the first layer member 10. Therefore, the biosensor 1 can be adhered to the skin 2 more stably, and the contact impedance between the electrode 20 and the surface of the skin 2 can be reduced. As a result, the biosensor 1 can stably maintain the adhesiveness to the skin 2 when in use, and can reduce the noise mixing of the biosignal, thereby improving the measurement accuracy.

[0177] In the biosensor 1, the upper sheet 12 constituting the first layer member 10 has a first base material 121 and a first adhesive layer 122, and the first adhesive layer 122 is formed using the above-mentioned bioadhesive according to the present embodiment. Therefore, the biosensor 1 can stably adhere the first adhesive layer 122 to the skin 2, and can make the electrode 20 contact the surface of the skin 2 in a state adhered to the first layer member 10 via the first adhesive layer 122. Thus, the biosensor 1 can be adhered to the skin 2 more stably, and the contact impedance between the electrode 20 and the surface of the skin 2 can be reduced.

[0178] The biosensor 1 includes a cover member 11 and an upper adhesive layer 123 in the first layer member 10, and the first base material 121 of the upper sheet 12 can have a through hole 121a. The first adhesive layer 122 has adhesiveness, so the electrode 20 can contact the surface of the skin 2 in a state of being stably attached to the first layer member 10 through the first adhesive layer 122. As a result, the biosensor 1 maintains a state in which the electrode 20 is stably attached to the skin 2, and even if the body moves, positional displacement can be suppressed, thereby reducing the contact impedance between the electrode 20 and the surface of the skin 2, suppressing the generation of noise, and more stably attaching to the skin 2. In addition, the first base material 121 has a shape corresponding to the outermost shape of the cover member 11, so that only the cover member 11 can be prevented from contacting the skin 2. As a result, the biosensor 1 can improve the detection accuracy of the biological signal during use, maintain the adhesiveness to the skin 2, and reduce the discomfort of the subject caused by contact with the outer periphery of the cover member 11.

[0179] The biosensor 1 includes a second layer member 40, and can have a second adhesive layer 43 on the surface of the second layer member 40 on the opposite side to the first layer member 10 side. Thus, the biosensor 1 can adhere the second layer member 40 to the skin 2 via the second adhesive layer 43, thereby reducing the contact impedance between the electrode 20 and the surface of the skin 2. Thus, the biosensor 1 can further improve the detection accuracy of the biological signal during use, and can further stably maintain the adhesion to the skin 2.

[0180] The biosensor 1 can form a bonding surface to the skin 2 by the first layer member 10, the electrode 20 and the second layer member 40. Thus, the thickness of the biosensor 1 can be reduced. Thus, the biosensor 1 can be made smaller and have lower contact impedance with the surface of the skin 2.

[0181] The biosensor 1 can form the second adhesive layer 43 of the second layer member 40 using the bioadhesive according to the present embodiment. The second adhesive layer 43 forms a bonding surface for the skin 2 similarly to the first adhesive layer 122, so the biosensor 1 can stably bond the second adhesive layer 43 to the skin 2.

[0182] The biosensor 1 can form the first adhesive layer 122 and the second adhesive layer 43 using the above-mentioned bioadhesive according to the present embodiment. The first adhesive layer 122 and the second adhesive layer 43 form the entire bonding surface of the biosensor 1 to the skin 2. Thus, the biosensor 1 can form the entire bonding surface to the skin 2 using the above-mentioned bioadhesive according to the present embodiment, thereby improving the adhesion to the skin 2 and further stably bonding to the skin 2.

[0183] Thus, the biosensor 1 can stably measure the biometric information from the skin 2 for a long time during use as described above, and can be effectively used as a stick-on biosensor to be used by being stuck to the human skin 2. The biosensor 1 can be stuck to the skin of a living body, for example, and is suitable for use in a wearable device for health that requires high sensitivity in detecting an electrocardiogram and high suppression effect of noise generated by the electrocardiogram.

[0184] As described above, the embodiments are described, but the above embodiments are provided as examples, and the present invention is not limited by the above embodiments. The above embodiments can be implemented in various other forms, and various combinations, omissions, substitutions, changes, etc. can be made within the scope of the subject matter of the invention. These embodiments and their variations are included in the scope and subject matter of the invention, and are included in the invention described in the claims and their equivalents.

[0185] Example

[0186] Hereinafter, the embodiment will be described in more detail with reference to Examples and Comparative Examples, but the embodiment is not limited to these Examples and Comparative Examples.

[0187] <Production of acrylic polymer>

[0188] [Preparation of acrylic polymer (polymer component A)]

[0189] A polymer containing isononyl acrylate, 2-methoxyethyl acrylate, and acrylic acid in a ratio of 65 parts by mass: 30 parts by mass: 5 parts by mass (hereinafter referred to as “polymer component A”) was prepared as an acrylic polymer.

[0190] [Preparation of acrylic polymer (polymer component B)]

[0191] A polymer containing 2-ethylhexyl acrylate, 1-vinyl-2-pyrrolidone, acrylic acid, and 4-hydroxybutyl acrylate in a ratio of 89.5 parts by mass: 6.0 parts by mass: 4.0 parts by mass: 0.5 parts by mass (hereinafter referred to as “polymer component B”) was prepared as an acrylic polymer.

[0192] [Preparation of acrylic polymer (polymer component C)]

[0193] A polymer containing isononyl acrylate, 2-methoxyethyl acrylate, and acrylic acid in a ratio of 65 parts by mass: 30.0 parts by mass: 5 parts by mass (hereinafter referred to as "polymer component C". High molecular weight type of component A) was prepared as an acrylic polymer.

[0194] [Preparation of acrylic polymer (polymer component D)]

[0195] A polymer containing 2-ethylhexyl acrylate and acrylic acid in a ratio of 95 parts by mass:5 parts by mass (hereinafter referred to as “polymer component D”) was prepared as an acrylic polymer.

[0196] <Production of adhesive for biological use>

[0197] [Preparation of Adhesive 1 for Living Organisms]

[0198] 100 parts by mass of polymer component A as a polymer, 20 parts by mass of a thickener (KE-311, manufactured by Arakawa Chemical Industries, Ltd.) as a thickener, and 0.075 parts by mass of a crosslinking agent (Colonate HL, manufactured by Nippon Polyurethane Industries, Ltd.) were mixed to prepare an adhesive composition. The adhesive composition was applied to prepare an adhesive 1 for organisms (length: 200 mm, width: 100 mm, thickness: 60 μm). The polymer molecular weight of the adhesive 1 for organisms was 700,000 to 800,000, the gel fraction was 41.8%, the glass transition temperature Tg was -40.4°C, and the saturated water content was 0.50% at 22°C RH50%, and 1.11% at 40°C RH92%.

[0199] [Production of Adhesive 2 for Living Organisms]

[0200] 100 parts by weight of polymer component B as a polymer and 0.1 parts by weight of a crosslinking agent (Colonate L, manufactured by Nippon Polyurethane Industries) were mixed to prepare an adhesive composition. The adhesive composition was applied to prepare an adhesive 2 for organisms (length: 200 mm, width: 100 mm, thickness: 30 μm). The polymer molecular weight of the adhesive 2 for organisms was 800,000 to 900,000, the gel fraction was 29.8%, the glass transition temperature Tg was -44.7°C, and the saturated water content was 0.33% at 22°C RH50% and 0.72% at 40°C RH92%.

[0201] [Production of Adhesive for Living Organisms 3]

[0202] 100 parts by mass of polymer component A as a polymer, 10 parts by mass of a thickener (Haritac PCJ, manufactured by Harima Chemical Co., Ltd.), 15 parts by mass of a liquid component (Coconard RK, manufactured by Kao Corporation) and 0.075 parts by mass of a crosslinking agent (Colonate HL, manufactured by Nippon Polyurethane Industries, Ltd.) were mixed to prepare an adhesive composition. The adhesive composition was applied to prepare an adhesive 3 for organisms (length: 200 mm, width: 100 mm, thickness: 60 μm). The polymer molecular weight of the adhesive 3 for organisms is 700,000 to 800,000, the gel fraction is 37.5%, the glass transition temperature Tg is -54.5°C, and the saturated water content is 0.52% at 22°C RH50% and 1.08% at 40°C RH92%.

[0203] [Preparation of Adhesive 4 for Living Organisms]

[0204] 100 parts by mass of polymer component C as a polymer, 10 parts by mass of a thickener (Haritac PCJ, manufactured by Harima Chemical Co., Ltd.), 15 parts by mass of a liquid component (Coconard RK, manufactured by Kao Corporation) and 0.075 parts by mass of a crosslinking agent (Colonate HL, manufactured by Nippon Polyurethane Industries, Ltd.) were mixed to prepare an adhesive composition. The adhesive composition was applied to prepare an adhesive 4 for organisms (length: 200 mm, width: 100 mm, thickness: 60 μm). The polymer molecular weight of the adhesive 4 for organisms is about 1.8 million, the gel fraction is 60.6%, the glass transition temperature Tg is -35.6°C, and the saturated water content is 0.51% at 22°C RH50% and 0.98% at 40°C RH92%.

[0205] [Preparation of Adhesive 5 for Living Organisms]

[0206] 100 parts by mass of polymer component D as a polymer and 5 parts by mass of a thickener (KE-311, manufactured by Arakawa Chemical Industries, Ltd.) were mixed to prepare an adhesive composition. The adhesive composition was applied to prepare an adhesive 5 for organisms (length: 200 mm, width: 100 mm, thickness: 40 μm). The polymer molecular weight of the adhesive 5 for organisms was 1.1 million to 1.3 million, the gel fraction was 6.5%, the glass transition temperature Tg was -56.2°C, and the saturated water content was 0.27% at 22°C RH50% and 0.55% at 40°C RH92%.

[0207] [Preparation of Adhesive 6 for Living Organisms]

[0208] An adhesive composition composed of 100 parts by mass of the polymer component D as a polymer was prepared. The adhesive composition was applied to prepare an adhesive 6 for organisms (length: 200 mm, width: 100 mm, thickness: 40 μm). The polymer molecular weight of the adhesive 6 for organisms was 1.1 million to 1.3 million, the gel fraction was 3.9%, the glass transition temperature Tg was -59.0°C, and the saturated water content was 0.22% at 22°C RH50% and 0.45% at 40°C RH92%.

[0209] <60° Peel Adhesion Test>

[0210] The above-mentioned adhesives 1 to 6 for living organisms are laminated on the main surface of one side of a support (PET, thickness: 25 μm) formed in a rectangular shape to produce a laminate (adhesive material for living organisms). Each of the above-mentioned laminates is attached to a human skin gel sheet (H0-1, manufactured by Excel Corporation). Then, under normal temperature and humidity conditions (22°C, 50RH%), the peeling angle between the human skin gel side of each laminate and the human skin gel sheet is set to 60°, and the peeling speed is set to 150 mm / min. The adhesive force (60° peeling adhesive force) when the laminate is peeled off from the human skin gel sheet from the end of the length direction of one side of the laminate is measured. In addition, the human skin gel sheet is stored under normal temperature and humidity conditions (22°C, 50RH%) for 3 days because the water content inside it is stabilized. The water content of the human skin gel sheet stored under normal temperature and humidity conditions for 3 days is about 0.65%.

[0211] (Measurement of 60° peeling adhesion when using human skin gel sheets stored under high temperature and high humidity conditions)

[0212] Instead of a human skin gel sheet stored under normal temperature and humidity conditions (22°C, 50RH%) for 3 days, a human skin gel sheet stored under high temperature and humidity conditions (60°C, 90RH%) was used. The water content of the human skin gel sheet stored under high temperature and humidity conditions for 3 days was about 1.89%. By storing the human skin gel sheet under high temperature and humidity conditions to increase the water content, a state close to skin moistened with sweat or skin moistened with water was simulated, and the 60° peeling adhesion was measured. After the human skin gel sheet was stored under high temperature and humidity conditions for 3 days, each organism was attached to the human skin gel sheet with an adhesive under high temperature and humidity conditions (60°C, 90RH%) and left for 10 minutes to 30 minutes. Then, the 60° peeling adhesion was measured in the same manner as above.

[0213] <Measurement of 180° peel adhesion>

[0214] After each of the above-mentioned adhesives 1 to 6 for biological use is pasted on a phenolic resin board (phenol laminated board, manufactured by Standard Testpiece Co., Ltd.), the peeling angle between the surface on the phenolic resin board side of each laminate and the phenolic resin board is set to 180°, and the adhesion (180° peeling adhesion) when the laminate is peeled off from the phenolic resin board from the end portion in the longitudinal direction of one side of the laminate is measured.

[0215] The thickness, composition, polymer molecular weight, gel fraction, glass transition temperature Tg and saturated water content of each adhesive for a living body, as well as the measurement results of the 60° peeling adhesion and 180° peeling adhesion of the laminate of each adhesive for a living body are shown in Table 1. The 60° peeling adhesion is the measurement results of the laminate stored at normal temperature and normal humidity conditions (22°C, 50RH%) and high temperature and high humidity conditions (60°C, 90RH%) for 3 days when the adherend is a human skin gel sheet. In addition, the measurement results of the 60° peeling adhesion of the laminate when the human skin gel sheet stored at normal temperature and normal humidity conditions (22°C, 50RH%) and high temperature and high humidity conditions (60°C, 90RH%) are used as the adherend are shown in Table 1. Figure 5 .

[0216] [Table 1]

[0217]

[0218] <Production of Biosensors>

[0219] [Example 1]

[0220] (Production of Covering Member)

[0221] A coating layer having a Shore hardness of A40 made of silicone rubber was formed on a support body formed using PET as a base resin, and the support body was molded into a predetermined shape to produce a covering member.

[0222] (Preparation of the first layer laminate)

[0223] The first adhesive layer was formed by pasting the bioadhesive 1 on the bottom of the first substrate (polyolefin foam sheet (FOLEC (registered trademark), manufactured by INOACCORPORATION Co., Ltd., thickness: 1 mm) formed in a rectangular shape. Then, a silicone tape (thickness: 60 μm) was pasted on the adhesive layer to form an upper adhesive layer, thereby producing a first laminated sheet.

[0224] (Electrode Preparation)

[0225] 1. Preparation of Conductive Composition

[0226] An aqueous solution containing 0.38 parts by mass of PEDOT / PSS particles (Orgacon DRY, manufactured by AGFA Materials, Japan) as a conductive polymer, 10.00 parts by mass of modified polyvinyl alcohol (modified PVA) as a binder resin (modified polyvinyl alcohol concentration: 10%, gohsenx Z-410, manufactured by Nippon Synthetic Chemical Co., Ltd.), 2.00 parts by mass of glycerol (manufactured by Wako Pure Chemical Industries, Ltd.) as a plasticizer, 1.60 parts by mass of 2-propylene glycol as a solvent, and 6.50 parts by mass of water were added to an ultrasonic bath. The aqueous solution containing these components was mixed in an ultrasonic bath for 30 minutes to prepare a uniform conductive composition aqueous solution A.

[0227] Since the concentration of the modified PVA in the aqueous solution containing the modified PVA is about 10%, the content of the modified PVA in the conductive composition aqueous solution A is 1.00 part by mass.

[0228] The contents of the conductive polymer, the binder resin, and the plasticizer were 11.2 parts by mass, 29.6 parts by mass, and 59.2 parts by mass, respectively, relative to 100.0 parts by mass of the conductive composition.

[0229] 2. Preparation of electrode sheets

[0230] The prepared conductive composition aqueous solution A was coated on a polyethylene terephthalate (PET) film using an applicator. The PET film coated with the conductive composition aqueous solution A was then transported to a drying oven (SPHH-201, manufactured by ESPEC), and the conductive composition aqueous solution A was heated and dried at 135° C. for 3 minutes to produce a solidified conductive composition. The solidified material was punched (pressed) into a desired shape and formed into a sheet to produce an electrode sheet (biological electrode) with a thickness of 20 μm.

[0231] The contents of the conductive polymer, binder resin, and plasticizer contained in the electrode sheet were 11.2 parts by mass, 29.6 parts by mass, and 59.2 parts by mass, respectively, similar to those in the conductive composition.

[0232] (Production of the second layer laminate)

[0233] Adhesives (permeroll, manufactured by Nitto Denko Corporation) were attached to both sides of the second substrate (PET (PET-50-SCA1 (white), manufactured by Mitsui & Co., Ltd.), thickness: 38 μm) formed in a rectangular shape, moisture permeability: 21 g / (m 2 ·day)), forming the lower adhesive layer and the second adhesive layer to produce the second layer laminate.

[0234] (Production of Biosensors)

[0235] A sensor unit having a battery and a control unit is provided in the central portion of the upper surface of the second laminate. Then, a pair of electrodes are attached to the adhesive surface side of the first adhesive layer in a state of being sandwiched between the first adhesive layer of the first laminate and the second laminate, and the electrodes are connected to the wiring of the sensor unit. Then, the sensor unit is arranged in a receiving space formed by the first laminate and the covering member, and the covering member is stacked on the first laminate in a manner that the connecting portion is located in a position substantially within the first sheet portion of the covering member when viewed from above, thereby manufacturing the biosensor.

[0236] [Examples 2 to 5, Comparative Example 1]

[0237] In Example 1, a biosensor was produced in the same manner as in Example 1 except that the bioadhesives 2 to 6 were used instead of the bioadhesive 1 to form the first adhesive layer.

[0238] <Evaluation of biosensor characteristics>

[0239] The biosensors of the above-mentioned examples and comparative examples were used to measure the bonding reliability. The bonding reliability was evaluated by a tensile durability test. The measurement results are shown in Table 2.

[0240] [Adhesion reliability]

[0241] 1. Tensile durability test

[0242] A high-performance artificial skin model (trade name: biomask, manufactured by BEAULAX Co., Ltd., hereinafter referred to as biomask) was used as a substitute for the skin, and the biosensor was pasted on the biomask and fixed. In addition, the biomask was stored at 22°C and 50RH% for 3 days to stabilize the moisture content inside. The biomask pasted with the biosensor was placed in a small table-top durability tester (surface state tensile tester, YUASA SYSTEM Equipment Co., Ltd.), and the biomask was placed so that the strain became 20%, and the elongation was repeated once every 3 seconds, and the number of times until the end of the biosensor peeled off was studied. When the number of repetitions of the elongation of the biomask was 36 or more, the biosensor was pasted on the biosensor for 24 hours. Even if the surface of the biosensor was deformed by body activities, the biosensor did not peel off from the surface of the biosensor, and it was evaluated that the biosensor could be obtained roughly stably (24-hour pasting limit). The relationship between the number of peeling times of the biosensors of the examples and comparative examples and the 60° peeling adhesive strength of the laminated bodies of the bioadhesives 1 to 6 used in the examples and comparative examples is shown in FIG. Figure 6 .

[0243] [Table 2]

[0244]

[0245] From Table 1 and Table 2, in each example, the tensile durability is 37 times or more, but in Comparative Example 1, the tensile durability is 35 times. Figure 6 The greater the 60° peeling adhesion of the laminate used in each of the examples and comparative examples, the greater the number of times the biosensor of each of the examples and comparative examples was peeled off.

[0246] Thus, it is confirmed that the bioadhesive of each of the above-mentioned embodiments exhibits high adhesive reliability to the surface of the skin by making the 60° peeling adhesive force be greater than a predetermined value. Therefore, it can be said that if the bioadhesive of the present embodiment is used as the first adhesive layer provided on the upper sheet of the biosensor and the bonding surface side of the organism, the biosensor can be continuously and effectively used to measure the electrocardiogram even if it is bonded to the skin of the subject for a long time (for example, 24 hours).

[0247] In addition, the embodiments of the present invention are as follows, for example.

[0248] <1> A living body adhesive, the living body adhesive being attached to a living body,

[0249] The above-mentioned biological adhesive is adhered to an adherend with a Shore C hardness of 0, the angle between the surface of the above-mentioned biological adhesive facing the above-mentioned adherend and the sticking surface of the above-mentioned adherend is set to 60°, and the peeling adhesion force when the above-mentioned biological adhesive is peeled off from the above-mentioned adherend is greater than 5.0N / cm.

[0250] <2> The biological adhesive according to <1>, wherein the glass transition temperature is -57°C or higher.

[0251] <3> The biological adhesive according to <1> or <2>, wherein the peel adhesive strength is a value measured by affixing the biological adhesive to polyethylene terephthalate on a surface different from the adherend, and affixing the biological adhesive to the adherend.

[0252] <4> A biosensor that is attached to a living body to obtain a biosignal, comprising:

[0253] The sensor body that acquires biological information,

[0254] an electrode connected to the sensor body, and

[0255] The electrode is attached to the bottom and has a first layer member having a storage space for storing the sensor body.

[0256] The first layer member comprises the living body adhesive according to any one of <1> to <3>.

[0257] <5> The biosensor according to <4>, wherein the first layer member comprises:

[0258] substrate, and

[0259] a first adhesive layer provided on the surface of the substrate facing the organism,

[0260] The first adhesive layer contains the biological adhesive.

[0261] <6> The biosensor according to <4> or <5>, wherein the first layer member comprises:

[0262] a covering member having a housing space for housing the sensor body and an opening of the housing space, and

[0263] The upper adhesive layer for adhering the above-mentioned covering member to the above-mentioned biological body with the adhesive,

[0264] The living body adhesive is provided on the opening side of the covering member and has a through hole at a position corresponding to the housing space.

[0265] <7> The biosensor according to any one of <4> to <6>, comprising: a second layer member attached to the lower surface of the first layer member so as to expose the electrode and cover the sensor body;

[0266] The second layer member has a second adhesive layer on a surface opposite to the first layer member.

[0267] <8> The biosensor according to <7>, wherein an adhesive surface to a living body is formed by the first layer member, the electrode, and the second layer member.

[0268] <9> The biosensor according to <7>, wherein the second adhesive layer is the bioadhesive according to any one of <1> to <3>.

[0269] The first layer member, the electrodes and the second layer member form an adhesive surface to a living body.

[0270] This application claims priority based on Japanese Patent Application No. 2022-118682 filed with the Japan Patent Office on July 26, 2022, and Japanese Patent Application No. 2023-42213 filed with the Japan Patent Office on March 16, 2023, and cites all the contents described in these applications.

[0271] Explanation of symbols

[0272] 1 Biosensor

[0273] 2 Skin

[0274] 101st layer components

[0275] 11 Covering components

[0276] 12 Upper piece

[0277] 12a, 121a, 122a through holes

[0278] 20, 20A, 20B electrodes

[0279] 20a Opposing part

[0280] 20b Exposed part

[0281] 30 Sensor unit

[0282] 31 Flexible Substrate

[0283] 32 Sensor body

[0284] 33A Connection

[0285] 33A, 33B connection part

[0286] 34 batteries

[0287] 40 Layer 2 Components

[0288] 41 2nd base material

[0289] 42 Adhesive layer for the lower part

[0290] 43 Second adhesive layer

[0291] 111 Protrusion

[0292] 111a pit

[0293] 121 No.1 Base Material

[0294] 1221st adhesive layer

[0295] 123 Adhesive layer for upper part

[0296] 321 Component mounting unit

[0297] 322 Battery Installation Department

[0298] 331A, 331B wiring

[0299] 332A, 332B terminal part

Claims

1. A living body adhesive, which is a living body adhesive to be attached to a living body, The bioadhesive is adhered to an adherend having a Shore C hardness of 0, the angle between the surface of the bioadhesive facing the adherend and the adhered surface of the adherend is set to 60°, and the peeling adhesion force when the bioadhesive is peeled off from the adherend is greater than 5.0 N / cm.

2. The adhesive for living body according to claim 1, The glass transition temperature is above -57°C.

3. The adhesive for living body according to claim 1, The peel adhesive strength is a value measured by attaching polyethylene terephthalate to a surface of the adhesive for a living body different from the surface of the adherend, and attaching the adhesive for a living body to the adherend.

4. A biosensor, which is a biosensor attached to a living body to obtain a biosignal, comprising: The sensor body that acquires biological information, an electrode connected to the sensor body, and The electrode is attached to the bottom and has a first layer member having a storage space for storing the sensor body. The first layer member comprises the biological adhesive according to claim 1 .

5. The biosensor according to claim 4, The first layer component comprises: substrate, and a first adhesive layer provided on the surface of the substrate facing the biological body, The first adhesive layer is the biological adhesive.

6. The biosensor according to claim 5, The first layer component comprises: a covering member having a housing space for housing the sensor body and an opening of the housing space, and The upper adhesive layer for adhering the cover member to the living body with an adhesive, The living body adhesive is provided on the opening side of the covering member and has a through hole at a position corresponding to the housing space.

7. The biosensor according to claim 4, comprising: a second layer member attached to the lower surface of the first layer member so as to expose the electrode and cover the sensor body; The second layer member has a second adhesive layer on a surface opposite to the first layer member.

8. The biosensor according to claim 7, The first layer member, the electrodes, and the second layer member form an adhesive surface to a living body.

9. The biosensor according to claim 7, The second adhesive layer is the adhesive for living body according to claim 1, The first layer member, the electrodes, and the second layer member form an adhesive surface to a living body.

Images