Biological sensor

Abstract

The biological sensor according to the present invention is a biological sensor that is affixed to a living body, and is provided with: a sensor main body that acquires biological information; an electrode that is connected to the sensor main body; a cover member that has a housing space for housing the sensor main body and an opening thereof, and that has a moisture permeability of 350 g / (m2 day) or less; and a second layer member that is provided on the opening side of the cover member, has a through-hole at a position corresponding to the housing space, has a moisture permeability of 3600 g / (m2. Day) or less, has a tensile strength of 5.0 N / 10 mm or less at a strain of 20%, and is adhered so as to cover the sensor main body while exposing the electrode on the surface of the first substrate on the opposite side of the cover member. The first base material has, in at least a portion of the outer peripheral portion thereof, a protruding portion that protrudes further than the outer peripheral portions of the cover member and the second layer member.

Description

Technical Field

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

[0002] In hospitals, clinics and other medical institutions, nursing facilities, and at home, for example, biosensors are used to measure biometric information such as electrocardiogram waveforms, pulse waves, brain waves, and myoelectricity. The biosensor has biometric electrodes that contact the biological body to obtain the biological information of the subject. When measuring the biometric information, the biosensor is attached to the skin of the subject, and the biometric electrodes are used to obtain electrical signals related to the biometric information, thereby measuring the biometric information.

[0003] As such a biosensor, for example, a biosensor is disclosed, which comprises: a sensor body; an electrode; a first layer component formed by stacking an upper sheet layer and capable of accommodating the sensor body; and a second layer component adhered to the surface of the first layer component on the biobody side and provided with the sensor body and the electrode exposed (for example, refer to patent document 1).

[0004] In the biosensor, a first adhesive layer is provided on the surface of the first layer member facing the organism, and a second adhesive layer is provided on the surface of the second layer member facing the organism, and the first adhesive layer and the second adhesive layer are adhered to the skin while the second layer member is adhered to the electrode of the first adhesive layer in a state of being exposed, thereby acquiring biometric information. In addition, the upper sheet is formed of a foam sheet and has moisture permeability, so that water vapor brought by sweat generated by the organism is released from the upper sheet to the outside.

[0005] Prior art literature

[0006] Patent Literature

[0007] Patent Document 1: Japanese Patent No. 6947955 Summary of the invention

[0008] Problems to be solved by the invention

[0009] Here, in the biosensor of Patent Document 1, the upper sheet is formed of a foam sheet having a bubble structure and is soft, so the biosensor easily deforms following the deformation of the surface of the organism and has excellent adhesion to the skin of the subject. However, if the upper sheet absorbs moisture from the outside, there is a possibility that the absorbed moisture passes through the inside of the upper sheet and contacts the sensor body accommodated in the first layer member.

[0010] Biosensors are often attached to a biological surface such as the skin of a subject and used for a long time. Therefore, in order to stably obtain electrical signals related to biological information for a long time, it is important to suppress the intrusion of moisture from the outside while maintaining a stable state of attachment to the biological surface.

[0011] An object of one aspect of the present invention is to provide a biosensor that suppresses the intrusion of moisture from the outside during use and can be stably attached to a living body.

[0012] Methods for solving problems

[0013] One embodiment of a biosensor according to the present invention is a biosensor attached to a living body, comprising:

[0014] The sensor body that acquires biological information,

[0015] An electrode connected to the sensor body,

[0016] The sensor body has a storage space and an opening for the storage space, and a moisture permeability of 350 g / (m 2 · days) or less,

[0017] The first substrate is provided on the opening side of the cover member, has a through hole at a position corresponding to the storage space, and has a moisture permeability of 3600 g / (m 2 · days) or less, the tensile strength at a strain of 20% is 5.0N / 10mm or less, and

[0018] a second layer member attached to the surface of the first substrate on the opposite side of the cover member so as to expose the electrode and cover the sensor body;

[0019] The first base has an overhanging portion protruding beyond the outer peripheries of the covering member and the second layer member at at least a portion of the outer periphery.

[0020] Effects of the Invention

[0021] One aspect of the biosensor according to the present invention can suppress the intrusion of moisture from the outside during use and can be stably attached to a living body. BRIEF DESCRIPTION OF THE DRAWINGS

[0022] Figure 1 It is a perspective view showing the overall structure of a biosensor according to an embodiment of the present invention.

[0023] Figure 2 It is a plan view showing an example of each component of the biosensor.

[0024] Figure 3is the cross-sectional view of the biosensor in the length direction, Figure 1 II cross-sectional view.

[0025] Figure 4 This is a cross-sectional view in the longitudinal direction of an example of another configuration of the biosensor.

[0026] Figure 5 This is a cross-sectional view in the longitudinal direction of an example of another configuration of a biosensor.

[0027] Figure 6 To express that Figure 1 An explanatory diagram showing a state in which a biosensor is attached to the chest of a living body.

[0028] Figure 7 It is a perspective view showing the structure of the test body.

[0029] Figure 8 A plan view of the test body. DETAILED DESCRIPTION

[0030] 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.

[0031] <Biosensor>

[0032] The biosensor involved in this embodiment is described. In addition, the biosensor refers to the human body (human), as well as animals such as cows, horses, pigs, chickens, dogs and cats. The biosensor involved in this embodiment can be used for a biological body, and can be used as a human body. In this embodiment, as an example, the case where the biological body is a human is described.

[0033] The biosensor involved in this embodiment is a stick-on biosensor that is attached to a part of a living body (e.g., skin, scalp, or forehead) to measure biometric information. In this embodiment, a case where the biosensor is attached to a person's skin to measure an electrical signal (biometric signal) related to the person's biometric information is described.

[0034] Figure 1 It is a perspective view showing the overall structure of the biosensor according to the present embodiment. Figure 1 The left side of shows the appearance of the biosensor involved in this embodiment. Figure 1 The right side of shows a state in which the components of the biosensor according to the present embodiment are disassembled. Figure 2It 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.

[0035] Figure 1 and Figure 2 As 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.

[0036] 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.

[0037] In addition, the biological signal is an electrical signal indicating, for example, an electrocardiogram waveform, a brain wave, a pulse, or the like.

[0038] The inventors of the present application have focused on the influence of the moisture permeability of the cover member 11 provided on the surface side of the first layer member 10, and the moisture permeability and tensile strength of the first base material 121 provided on the biological body side relative to the cover member 11 on waterproofness and adhesion to the surface of the skin 2 when the biosensor 1 is used. The inventors of the present application have studied the effects of reducing the moisture permeability of the cover member 11, making the moisture permeability of the first base material 121 higher than that of the cover member 11, and suppressing the tensile strength of the first base material 121. As a result, the inventors of the present application have found that by making the first base material 121 protrude from the cover member 11 and the second layer member 40 and making it easy to contact with external moisture, it is possible to suppress the intrusion of external water into the inside of the biosensor 1 and maintain the adhesion of the biosensor 1 to the biological body.

[0039] [1st layer components]

[0040] Figure 1 and Figure 2 As shown, the first layer member 10 is provided with a cover member 11 and an upper sheet 12 which are sequentially stacked. The upper sheet 12 has a shape slightly larger than the cover member 11 in a plan view.

[0041] (covering member)

[0042] 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 1 The 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.

[0043] 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 have a size that can accommodate at least a part of the sensor portion 30. On the inner side (sticking side) of the protruding portion 111, the pit 111a on the inner surface of the portion 111, the electrode 20 and the second layer member 40 form a storage space S for accommodating the sensor portion 30.

[0044] 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 stacking the above-mentioned flexible material on the surface of the support using a base resin such as polyethylene terephthalate (PET) as a support. By forming the covering member 11 using the above-mentioned flexible material, the sensor portion 30 configured in the storage space S of the protecting 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 portion 30 is mitigated.

[0045] 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.

[0046] 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.

[0047] 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.

[0048] 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 the case where the thickness of the outer periphery of the flat portions 112A and 112B is not reduced. In addition, as described later, when the surface of the skin 2 is deformed, the stress applied to the flat portions 112A and 112B can be reduced.

[0049] The moisture permeability of the covering member 11 is 350 g / (m 2 ·day) or less, preferably 330g / (m 2 ·day) or less, more preferably 310g / (m 2 If the moisture permeability of the covering member 11 is 350 g / (m 2 · days) or less, when water vapor brought by sweat or the like generated by skin 2 to which biosensor 1 is attached reaches cover member 11, the water vapor can be released to the outside of biosensor 1 through cover member 11.

[0050] The method for calculating the moisture permeability of the covering member 11 is not particularly limited, and a general method can be used. For example, the moisture permeability can be calculated using the following procedure.

[0051] (1) A weighing bottle having an opening having a predetermined area S is prepared, and sufficient water is poured into the weighing bottle so that the liquid level is located below the opening.

[0052] (2) A part or all of the covering member 11 is arranged as a measurement sample on the entire surface of the opening of the weighing bottle so that no tension is applied to the covering member 11, the measurement sample is fixed to the weighing bottle, and the weighing bottle is sealed.

[0053] (3) Measure the total mass M1 of the test sample, water and weighing bottle immediately after sealing.

[0054] (4) Place the sealed weighing bottle at 40°C and 30% RH for 24 hours.

[0055] (5) Measure the total mass M2 of the measurement sample, water and weighing bottle after leaving it for 24 hours.

[0056] (6) The moisture permeability P is calculated from the following formula (1).

[0057] Moisture permeability P = (total mass M1 - total mass M2) / predetermined area S (1)

[0058] The hardness (strength) of the covering member 11 can be designed to be any appropriate size, for example, it can be 10 to 40. If the hardness of the covering member 11 is within the above preferred range, when the skin 2 is stretched by body movement, it can be unaffected by the covering member 11, and the upper sheet 12, the electrode 20 and the second layer member 40 can be easily deformed according to the movement of the skin 2. 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 (JIS K 6253: 2012). The Shore A hardness is an A-type durometer hardness measured by a rubber durometer (A-type durometer) using an A-type (cylindrical) indenter.

[0059] (Upper piece)

[0060] Figure 3 As shown in the figure, the upper sheet 12 is bonded to the lower surface of the cover member 11. The upper sheet 12 has a through hole 12a at a position opposite to the protrusion 111 of the cover member 11. Through the through hole 12a, the sensor body 32 of the sensor unit 30 is not blocked by the upper sheet 12, and can be stored in the storage space S formed by the recess 111a on the inner surface of the cover member 11 and the through hole 12a.

[0061] The upper sheet 12 has an extension 12A that protrudes outwardly from the cover member 11 when viewed from above, and is formed to have a shape that is larger outwardly than the cover member 11. That is, the extension 12A is the outer peripheral portion of the first base material 121 that is not covered by the cover member 11, and protrudes from the outer peripheral portion of the cover member 11 in a state where the cover member 11 is attached.

[0062] The extension amount (protrusion length) of the extension portion 12A from the outer periphery of the upper sheet 12 can be set to an appropriate arbitrary size, for example, it can be set to about several mm, preferably 3 mm to 10 mm, and more preferably 5 mm to 7 mm. In addition, the extension amount of the extension portion 12A can be the protrusion length from the outer periphery of the cover member 11. In addition, when the outer periphery of the cover member 11 has a partial depression or protrusion when the biosensor 1 is viewed from above, the extension amount of the extension portion 12A can be the shortest distance.

[0063] 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 .

[0064] The extension portion 12A may be composed of two layers, namely, the extension portion 121A of the first base material 121 and the extension portion 122A of the first adhesive layer 122 constituting the upper sheet 12. In addition, the extension portion 12A may be formed as long as it includes the extension portion 121A of the first base material 121. For example, Figure 4 As shown, the extension portion 12A may be composed of only the extension portion 121A. Figure 5 As shown, the extension part 12A may be composed of three layers, namely, the extension part 121A, the extension part 122A, and the extension part 123A of the upper adhesive layer 123. In order to prevent sticking to clothes or the like, or adhesion of garbage or the like, the extension part 12A may not include the extension part 123A.

[0065] ((First base material))

[0066] 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. The first substrate 121 has flexibility, water resistance, and moisture permeability, so that 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 brought 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.

[0067] 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 or the like generated by the skin 2 to which the biosensor 1 is attached to the biosensor 1 to the outside of the biosensor 1 through the first substrate 121, so it is preferred.

[0068] As the non-porous body, a molded body formed in a sheet shape can be used.

[0069] As porous body, can have the bubble structure such as continuous bubble, independent bubble, semi-independent bubble.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.

[0070] 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.

[0071] 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.

[0072] When the first substrate 121 is a non-porous body, specifically, a polyurethane sheet such as S-URS manufactured by Nippon Matai Co., Ltd. can be used.

[0073] 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.

[0074] The first substrate 121 has an extension portion 121A. The first substrate 121 has moisture permeability, thereby being able to efficiently release water vapor brought by sweat or the like from the extension portion 121A, and being able to suppress the retention of moisture such as sweat or the like between the first substrate 121 and the skin 2. This can suppress rashes on the skin and can suppress the peeling of the extension portion 121A.

[0075] The first base material 121 may be set to have higher elasticity than the covering member 11 .

[0076] The moisture permeability of the first substrate 121 only needs to be higher than that of the cover member 11. The moisture permeability of the first substrate 121 is 3600 g / (m 2 ·day) or less, preferably 3500g / (m 2 ·day) or less, more preferably 2000g / (m 2 The lower limit of the moisture permeability of the first substrate 121 is 100 g / (m 2 If the moisture permeability of the first substrate 121 is 3600g / (m 2 · days), the intrusion of water vapor from the outside is suppressed.

[0077] The method for calculating the moisture permeability of the first base material 121 is not particularly limited, and a general method can be used. The same method as the measurement method of the moisture permeability of the cover member 11 can be used.

[0078] 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 outer periphery of the cover member 11. If the thickness of the first substrate 121 is thicker than the thickness of the outer periphery of the cover member 11, it is possible to reduce the irritation caused by the outer periphery of the cover member 11 contacting the skin 2. The thickness of the first substrate 121 is preferably, for example, 10 μm to 1.5 mm, and more preferably 0.7 mm to 1.0 mm.

[0079] 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, and more preferably 1.0 mm to 1.3 mm.

[0080] 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 30 μm to 200 μm.

[0081] Figure 3 As shown in the figure, the first base material 121 has a through hole 121a at a position opposite to 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 also 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.

[0082] ((First adhesive layer))

[0083] Figure 3 As shown, 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 is located on the surface of the first substrate 121 on the biological body side (-Z axial direction), and has the functions of bonding the skin 2 to the first substrate 121, bonding the first substrate 121 to the second substrate 41, and bonding the first substrate 121 to the electrode 20.

[0084] The first adhesive layer 122 may have moisture permeability. Thus, as described later, 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 base material 121 through the first adhesive layer 122, and be released from the first base material 121 to the outside of the biosensor 1. When the first base material 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. Thus, 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.

[0085] 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.

[0086] As the material forming the first adhesive layer 122, a material having pressure-sensitive adhesive properties can be used. As the material having pressure-sensitive adhesive properties, for example, acrylic adhesives, silicone adhesives, etc. can be used, and acrylic adhesives are preferably used. As acrylic adhesives, for example, acrylic polymers described in Japanese Patent Publication No. 2002-65841 can be cited.

[0087] The first adhesive layer 122 may be an adhesive tape formed of the above-mentioned materials.

[0088] The first adhesive layer 122 can be formed with a wave-shaped pattern (reticular pattern) formed by repeated alternation of recesses thinner than other parts (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 that both the part where the adhesive on the surface of the first adhesive layer 122 is easy to contact with the organism and the part where it is difficult to contact with the organism exist. Since both the part where the adhesive exists and the part where the adhesive does not exist exist on the surface of the first adhesive layer 122, the part where the surface of the first adhesive layer 122 is easy to contact with the organism can be located. The thinner the adhesive is, the higher the moisture permeability of the first adhesive layer 122 tends to be. Therefore, the first adhesive layer 122 forms a reticular pattern on its surface, and has a part where the thickness of the adhesive is thin, so that compared with the case where the reticular pattern is not formed, it is possible to maintain adhesion while improving moisture permeability. In addition, the shape of the concave portion may be a linear shape or a circular shape other than a wave shape.

[0089] The width of the adhesive forming part and the non-adhesive part can be appropriately designed. For example, the width of the adhesive forming part is preferably 500 μm to 1000 μm, and the width of the adhered part is preferably 1500 μm to 5000 μm. If the widths of the adhesive forming part and the non-adhesive part are each within the above preferred range, the first adhesive layer 122 can maintain the adhesive force while exerting excellent moisture permeability.

[0090] The thickness of the first adhesive layer 122 can be set appropriately and arbitrarily, and can be, for example, 10 μm to 300 μm. If the thickness of the first adhesive layer 122 is 10 μm to 300 μm, the biosensor 1 can be made thinner.

[0091] The first adhesive layer 122 has an extended portion 122A. The extended portion 122A protrudes from the outer periphery of the cover member 11, so that the adhesion area to the skin 2 can be increased compared to the case where the upper sheet 12 and the cover member 11 are formed in the same size. This can improve the adhesion of the biosensor 1 to the skin 2.

[0092] Furthermore, when the biosensor 1 is attached to the skin 2 and the skin 2 is deformed due to the subject's physical activity, the biosensor 1 deforms following the deformation of the skin 2. At this time, the extension portion 121A is located at a position protruding from the outer periphery of the covering member 11, so that when the skin 2 is deformed, the end of the outer periphery of the covering member 11 can be suppressed from directly contacting the skin. Therefore, stimulation of the skin 2 by the outer periphery of the covering member 11 can be suppressed, and the occurrence of pain or itching of the skin 2 can be suppressed.

[0093] When the skin 2 stretches due to body movement, the outer peripheral portion of the upper sheet 12 stretches following the stretch of the skin 2. At this time, the stress applied to the covering member 11 is relieved by the deformation of the first adhesive layer 122 of the upper sheet 12 and the upper sheet 12, thereby suppressing the deformation of the upper adhesive layer 123. That is, the extension portion 12A of the upper sheet 12 can function as a buffer material that absorbs the stretch of the skin 2, and a part of the stretch of the skin 2 can be absorbed by the extension portion 12A.

[0094] Thus, the elongation of the outer periphery of the covering member 11 caused by the elongation of the skin 2 can be reduced. Therefore, it is possible to suppress the skin 2 from being stretched in the direction of contraction due to the reaction force of the elongation of the outer periphery of the covering member 11 accompanying the elongation of the skin 2, and it is possible to suppress the occurrence of pain or itching caused by the body movement of the skin 2 to which the outer periphery of the biosensor 1 is attached. As a result, the subject's sense of installation when attaching the biosensor 1 to the skin 2 can be improved.

[0095] In addition, the contact area of ​​the first adhesive layer 122 of the upper sheet 12 with the skin 2 can be increased compared to the case where the upper sheet 12 and the cover member 11 are formed in the same size. Thus, the adhesive force of the first adhesive layer 122 can be weakened compared to the case where the upper sheet 12 and the cover member 11 are formed in the same size. The adhesive force per unit area of ​​the first adhesive layer 122 can be reduced, thereby allowing the biosensor 1 to be easily peeled off from the skin 2 without reducing the adhesion performance of the biosensor 1 to the skin 2. For example, the biosensor 1 can be peeled off from the skin 2 without using a tool such as a remover, and the subject can feel no pain.

[0096] In addition, in the present embodiment, the extension portion 12A is made to protrude from the entire surface of the outer periphery of the covering member 11, but only a part of the extension portion 12A may be made to protrude from the outer periphery of the covering member 11. That is, the extension portion 12A may be provided only at a position in the biosensor 1 that is easily peeled off from the skin 2 by body movement or the like.

[0097] For example, when the biosensor 1 is attached to the living body P so that the flat portion 112A side of the cover member 11 is located on the ventral side of the living body P (see Figure 6), the ventral side is more likely to be displaced by body movement than the flat portion 112B side, and the biosensor 1 is more likely to be peeled off than the flat portion 112B side. Therefore, the extension 12A is preferably provided at least at the end of the cover member 11 on the flat portion 112A side.

[0098] In addition, the ends of the biosensor 1 in the length direction (Y-axis direction) tend to be more displaced by body movement than the ends in the width direction (X-axis direction), and are therefore more likely to peel off. Therefore, the extension 12A is preferably provided only at the two ends of the biosensor 1 in the length direction (Y-axis direction).

[0099] The extension 12A is provided at the easily peelable portion of the biosensor 1, so that, as described above, the pressing force of the covering member 11 on the skin when the skin 2 is deformed due to body movement can be dispersed within the upper sheet 12. Thus, the peeling of the biosensor 1 can be suppressed by the reaction force from the skin to the pressing force of the covering member 11 toward the extension 12A.

[0100] ((Adhesive layer for the upper part))

[0101] Figure 3 As 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.

[0102] 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.

[0103] The thickness of the upper adhesive layer 123 can be appropriately set, and may be, for example, 10 μm to 300 μm.

[0104] [electrode]

[0105] Figure 3As 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.

[0106] 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.

[0107] 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.

[0108] The electrode 20 may have any shape such as a sheet shape.

[0109] 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.

[0110] Electrodes 20A and 20B are as follows Figure 2 and Figure 3As 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.

[0111] 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 an adhesive electrode sheet formed in a sheet form using a cured product of the conductive composition.

[0112] As the conductive polymer, for example, polythiophene conductive polymers, polyaniline conductive polymers, polyacetylene conductive polymers, polypyrrole conductive polymers, polyphenylene conductive polymers and derivatives thereof, and composites thereof, etc. can be used. Among these, a composite in which polythiophene is doped with polyaniline as a dopant is preferred. Among the composites of polythiophene and polyaniline, from the perspective of lower contact impedance with a biological body and high conductivity, 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 is more preferably used.

[0113] As the binder resin, a water-soluble polymer or a water-insoluble polymer can be used. As the water-soluble polymer, a polymer containing a hydroxyl group such as polyvinyl alcohol (PVA) and modified PVA can be used.

[0114] 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.

[0115] As the metal and the alloy, general metals and alloys such as Au, Pt, Ag, Cu, and Al can be used.

[0116] The thickness of the electrode 20 can be set to any appropriate height, and can be, for example, 10 μm to 100 μm. When the thickness of the electrode 20 is within the above-described preferred range, sufficient strength and flexibility can be imparted to the electrode 20 .

[0117] The thickness of the electrode 20 refers to the length in the direction perpendicular to the surface of the electrode 20. The thickness of the electrode 20 is, for example, the thickness when measuring any location in the cross section of the electrode 20. When measuring multiple locations at any location, it may be the average value of the thicknesses at these measurement locations.

[0118] (Sensor part)

[0119] Figure 2 As 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 .

[0120] The flexible substrate 31 is a resin substrate on which various components for acquiring biological information are mounted, and the flexible substrate 31 includes a sensor body 32 and connection portions 33A and 33B.

[0121] 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.

[0122] 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.

[0123] 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.

[0124] 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.

[0125] 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.

[0126] 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.

[0127] 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 .

[0128] A well-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.

[0129] [Layer 2 components]

[0130] 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 .

[0131] 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.

[0132] (Second base material)

[0133] 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.

[0134] 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 .

[0135] The thickness of the second substrate 41 can be appropriately and arbitrarily selected, and can be, for example, 1 μm to 300 μm.

[0136] (Adhesive layer at the bottom)

[0137] 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.

[0138] (Second adhesive layer)

[0139] 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 that comes into contact with the skin 2 .

[0140] 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.

[0141] 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.

[0142] 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.

[0143] 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.

[0144] 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.

[0145] 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.

[0146] 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, since the upper sheet 12 has a bubble structure as described above, water vapor can be released to the outside of the biosensor 1 through the second adhesive layer 43. Thus, 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.

[0147] The moisture permeability of the second adhesive layer 43 is preferably, for example, 300 g / (m 2 ·day)~10000g / (m 2 If the moisture permeability of the second adhesive layer 43 is within the above-mentioned preferred 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.

[0148] The thickness of the second adhesive layer 43 can be appropriately selected, but is preferably 10 μm to 300 μm. When the thickness of the second adhesive layer 43 is 10 μm to 300 μm, the biosensor 1 can be made thinner.

[0149] 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 surface where the electrode 20 and the second substrate 41 are attached to the skin 2, so 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.

[0150] 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.

[0151] 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.

[0152] 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.

[0153] Figure 6 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 6 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.

[0154] Thus, the biosensor 1 includes the first layer member 10, the electrode 20, the sensor body 32, and the second layer member 40. The first layer member 10 is provided with the extension 12A. The moisture permeability of the cover member 11 of the first layer member 10 is 300 g / (m 2 ·days) or less, the moisture permeability of the first substrate 121 is 3600g / (m 2 ·day) or less, and the tensile strength when the strain of the skin 2 is 20% is 5.0N / 10mm or less. By setting the moisture permeability of the covering member 11 to 300g / (m 2 ·day) or less, and the moisture permeability of the first substrate 121 is 3600g / (m 2 ·day) or less, thereby suppressing the intrusion of water from the outside. In addition, the first substrate 121 can improve flexibility by making the tensile strength of the skin 2 surface 20% strained to be 5.0N / 10mm or less, so that the biosensor 1 can be easily stretched in the longitudinal direction, thereby improving the adhesion of the biosensor 1 to the biological surface. As a result, the biosensor 1 can improve waterproofness and be stably adhered to the biological body.

[0155] The waterproof index of the biosensor 1 can be appropriately set according to the size of the extension 12A, etc. For example, water is supplied from a water supply device such as a sprinkler nozzle to the upper surface of the extension 12A at a water pressure of 30 kPa, a water volume of 12.5 L / min, and a supply time of 3 minutes. At this time, when the biosensor 1 is viewed from above, whether the distance of the extension 12A from the boundary with the cover member 11 to the inner side immersed in water is less than a predetermined value (for example, 3 mm) can be used as a reference.

[0156] The water immersion distance refers to the length of the outer peripheral surface (side surface) of the cover member 11 in a direction perpendicular to the inner side of the cover member 11 when the biosensor 1 is viewed from above.

[0157] In addition, the water supply method can be any method that can supply water to the top of the extension portion 12A at a predetermined flow rate for a certain period of time. As the water supply method, for example, it can be a method of spraying water (spraying) on ​​the top of the extension portion 12A using a sprinkler, a sprinkler nozzle, etc., or a method of spraying water (jetting) on ​​the top of the extension portion 12A while maintaining the speed from a spray nozzle, etc.

[0158] The adhesiveness of the biosensor 1 can be evaluated by using a general evaluation method, for example, by measuring the adhesiveness of the biosensor 1 and the number of peeling durability.

[0159] The attaching operability of the biosensor 1 can be evaluated by, for example, attaching the biosensor 1 to a subject for a predetermined period of time (eg, 24 hours) and checking whether wrinkles are present on the first substrate 121 and whether the subject feels itchy.

[0160] The peeling durability number of the biosensor 1 is, for example, after attaching the biosensor 1 to a simulated skin having the same elasticity as the skin, the end portion corresponding to one end of the biosensor 1 in the longitudinal direction is fixed to the simulated skin. The simulated skin used for evaluation can be, for example, a biomask (manufactured by BURAKU Co., Ltd., No. P001-001) in which the surface of a urethane elastomer film is processed to reproduce the hydrophilicity and hydrophobicity and surface wrinkles close to those of human skin. Furthermore, the strain (elongation) of the simulated skin is set to 20%, and the simulated skin is repeatedly stretched and contracted as a whole at a frequency of a predetermined time (for example, 1 minute) and a predetermined number of times (for example, 20 times). The number of times the other end of the biosensor 1 in the longitudinal direction is peeled off from the simulated skin can be measured as the durability number.

[0161] In addition, the biosensor 1 is provided with an extension portion 12A on the first base material 121. The extension portion 12A includes an extension portion 121A of the first adhesive layer 122. Thus, the biosensor 1 can be hardly peeled off from the skin 2, and thus the biosensor 1 can be stably attached to the skin 2 for a long time, compared with the case where the upper sheet 12 and the cover member 11 are formed in the same size. Thus, the biosensor 1 can extend the measurement time of the biological information.

[0162] The biosensor 1 is provided with an extension 12A on the first substrate 121, so that when the skin 2 is deformed due to physical activity, the edge of the outer periphery of the covering member 11 can be suppressed from directly contacting the skin 2, thereby reducing the stimulation (occurrence of pain) of the skin by the outer periphery of the covering member 11. In particular, when the first substrate 121 is a porous body, even when the end of the outer periphery of the covering member 11 is directed toward the skin 2 due to the deformation of the skin 2, the biosensor 1 can disperse the pushing force of the outer periphery of the covering member 11 on the skin 2 in the upper sheet 12, and can reduce the stimulation to the skin 2.

[0163] The extension portion 121A can function as a buffer material that absorbs the elongation of the skin 2, and thus can suppress the stretching of the skin 2 in the direction of contraction due to the reaction force of the elongation of the outer peripheral portion of the covering member 11 accompanying the elongation of the skin 2. Therefore, the biosensor 1 can suppress the skin 2 to which the outer peripheral portion is attached from causing pain due to physical movement, thereby improving the installation feeling during installation of the biosensor 1.

[0164] The extension 121A can disperse the pressing force of the covering member 11 on the skin when the skin 2 is deformed by body movement within the upper sheet 12, thereby suppressing the peeling of the biosensor 1 by the reaction force of the skin 2 from the covering member 11 to the pressing force. As a result, the biosensor 1 is difficult to peel off from the skin 2, and the adhesive force of the first adhesive layer 122 of the upper sheet 12 can be weakened. As a result, the biosensor 1 can reduce the irritation of the skin 2 by the first adhesive layer 122.

[0165] The extension portion 12A includes the extension portion 122A of the first adhesive layer 122, so that the contact area of ​​the first adhesive layer 122 with the skin 2 can be increased. Therefore, even if the adhesive force of the first adhesive layer 122 is weakened, the biosensor 1 can be attached to the skin 2, so that the living body P does not feel pain and can be easily peeled off from the living body P after use.

[0166] The biosensor 1 can use a polyurethane-based thermoplastic elastomer to form the first substrate 121. If the first substrate 121 is formed of a polyurethane-based thermoplastic elastomer, the thickness of the first substrate 121 can be adjusted to any thickness, thereby reliably controlling the moisture permeability of the first substrate 121 to 3600 g / (m 2 · days) or less, and the tensile strength when the skin 2 is strained by 20% is 5.0 N / 10 mm or less. Therefore, the biosensor 1 can surely suppress the intrusion of water from the outside and surely exert waterproof properties, and can stably maintain the adhesion to the skin 2.

[0167] The biosensor 1 can include the first adhesive layer 122 and the upper adhesive layer 123 on the first layer member 10. 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 adhered to the first layer member 10 through the first adhesive layer 122. Therefore, the biosensor 1 can reduce the contact impedance between the electrode 20 and the surface of the skin 2, suppress the generation of noise, and adhere to the skin 2 more stably. As a result, the biosensor 1 can improve the detection accuracy of the biological signal during use and stably maintain the adhesion to the living body.

[0168] The biosensor 1 can include the 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 further reducing the contact impedance between the electrode 20 and the surface of the skin 2, further suppressing the generation of noise, and further stably adhering to the skin 2. Thus, the biosensor 1 can further improve the detection accuracy of the biological signal during use, and further stably maintain the adhesion to the skin 2.

[0169] 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 more compact, reduce the contact impedance with the surface of the skin 2, and can be stably bonded to the skin 2.

[0170] 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.

[0171] 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.

[0172] Example

[0173] 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.

[0174] <Example 1>

[0175] [Production of Laminated Body]

[0176] (Production of Covering Member)

[0177] Silicone rubber 1 (CHN-9300-U, manufactured by Topco) and silicone rubber 2 (CHN-9500-U, manufactured by Topco) were mixed at a ratio of 1:1 to produce a mixture with a Shore A hardness of 40. This mixture was used as a base resin to produce a rectangular cover member with a width of 50 mm × a length of 55 mm × a thickness of 1 mm. The moisture permeability of the cover member was 307 g / (m 2 · days). The moisture permeability was measured in the same manner as the moisture permeability measurement method of the first substrate 1 described later.

[0178] (Production of the upper piece)

[0179] A rectangular double-sided adhesive tape (KE311, manufactured by Nitto Denko Corporation) with a width of 50 mm × a length of 60 mm × a thickness of 1 mm is pasted as the first adhesive layer below the first substrate 1 (polyurethane sheet (S-URS, manufactured by Japan Matai Co., Ltd.) formed as a porous substrate with a width of 50 mm × a length of 60 mm × a thickness of 30 μm. In addition, the double-sided adhesive tape is a double-sided adhesive tape formed with an adhesive (acrylic resin) on its surface. Then, a rectangular silicone tape (ST503 (HC) 60, manufactured by Nitto Denko Corporation, thickness: 60 μm) with a width of 50 mm × a length of 60 mm × a thickness of 1 mm is pasted as an upper adhesive layer on the adhesive layer to produce an upper sheet.

[0180] (Production of Laminated Body)

[0181] Next, a rectangular skin band ("skin band for patch-type electrocardiograph EG Holter", manufactured by Nitto Denko Corporation) with a width of 50 mm x length of 55 mm x thickness of 1 mm was attached to the bottom of the upper sheet as a lower adhesive layer. Figure 7 As shown in the figure, a laminated body in which the lower adhesive layer, the first laminate sheet and the covering member were laminated in this order was prepared as a test body. The protrusion amount of the covering member, the upper adhesive layer and the first base material 1 of the skin tape was 5 mm.

[0182] [Characteristics of the first substrate]

[0183] The moisture permeability and tensile strength of the first substrate 1 were measured.

[0184] (Moisture Permeability)

[0185] The water vapor permeability of the first substrate 1 is measured according to the following procedure.

[0186] (1) Prepare a 38 mm diameter (opening area S: 1.13354 × 10 -3 m 2 ), a weighing bottle with a height of 40 mm, and 10 mL of purified water is injected into the weighing bottle.

[0187] (2) The first substrate 1 is placed on the entire surface of the opening of the weighing bottle so that no tension is generated on the first substrate 1. Next, the end of the first substrate 1 is fixed to the side surface of the weighing bottle using an adhesive tape to seal the weighing bottle.

[0188] (3) The total mass M1 of the first substrate 1, water, and the weighing bottle immediately after sealing is measured.

[0189] (4) Place the sealed weighing bottle at 40°C and 30% RH for 24 hours.

[0190] (5) After being left to stand for 24 hours, the total mass M2 of the first substrate 1, water, and the weighing bottle is measured.

[0191] (6) The moisture permeability P is calculated from the following formula (1).

[0192] Moisture permeability P = (total mass M1 - total mass M2) / predetermined area S (1)

[0193] (tensile strength)

[0194] The tensile strength was measured by a tensile test according to JIS K7161. The first substrate 1 was placed in a tensile testing machine (manufactured by Shimadzu Corporation, Autoplotter AG-IS), and both sides in the long side direction were fixed with clamps (chucks), and one clamp side was stretched to obtain the strength of the first substrate 1 at break. The strength of the first substrate 1 at break was evaluated as the tensile strength of the first substrate 1. The measurement conditions were a distance of 20 mm between chucks, a tensile speed of 300 mm / min, and a measurement temperature of (25±10)°C.

[0195] <Examples 2, 3>

[0196] In Example 1, except that the thickness of the first substrate 1 was changed as shown in Table 1, a test piece was prepared in the same manner as in Example 1.

[0197] <Comparative Examples 1, 2>

[0198] In Example 1, a test body was prepared in the same manner as in Example 1 except that the first substrate 1 was changed to the first substrate 2 or the first substrate 3 described below as shown in Table 1.

[0199] · First substrate 2: a polyolefin-based foam sheet having a semi-open cell structure (FOLEC (registered trademark), manufactured by INOAC CORPORATION, width 50 mm×length 60 mm×thickness 1000 μm)

[0200] · First substrate 3: a low-density polyethylene foam sheet having a closed cell structure (Volara, manufactured by Sekisui Chemical Co., Ltd., width 50 mm×length 60 mm×thickness 1000 μm)

[0201] Table 1 shows the evaluation results of the type, thickness, and characteristics of the first substrate in each of the above-mentioned Examples and Comparative Examples.

[0202] <Evaluation of biosensor characteristics>

[0203] The test bodies of the examples and comparative examples were regarded as biosensors, and the adhesiveness and waterproofness of the test bodies were measured and evaluated. Table 1 shows the evaluation results of the adhesiveness and waterproofness of the test bodies of the examples and comparative examples.

[0204] [Adhesion]

[0205] As the adhesiveness of the test piece, the sticking workability and the peeling durability number of the test piece were measured and evaluated.

[0206] (Paste operability)

[0207] After the test piece was attached to the subject for 72 hours, the presence or absence of wrinkles on the first substrate and whether the subject felt itchy were confirmed and evaluated based on the following evaluation criteria.

[0208] (Evaluation Criteria)

[0209] A: No wrinkles were observed on the first substrate, and the subject did not feel itchy.

[0210] B: Wrinkles were slightly observed on the first substrate, but the subject did not feel itchy.

[0211] C: Large wrinkles were observed on the first substrate, and the subject felt itchy.

[0212] (Peeling durability times)

[0213] After attaching the test body to a simulated skin having the same elasticity as the skin, the end corresponding to one end of the laminate in the length direction is fixed to the simulated skin. The simulated skin used for evaluation uses a biological mask (P001-001, manufactured by BURAKU Co., Ltd.) that processes the surface of a urethane elastomer film to reproduce hydrophilicity and surface wrinkles close to human skin. The strain (elongation) of the simulated skin is set to 20%, and the simulated skin is repeatedly stretched and retracted as a whole at a frequency of 20 times per minute. The number of times the other end of the length direction of the test body is peeled off from the simulated skin is measured as the durability number.

[0214] [Waterproof]

[0215] Water was sprayed from the top of the test piece through a sprinkler nozzle at a rate of 10 L / min for 10 minutes. Figure 8 As shown in the figure, the water immersion distance from the boundary with the covering member of the extension to the inside when viewed from above was measured, and the waterproofness was evaluated based on the following evaluation criteria. In addition, the water immersion distance is the length of the outer peripheral surface of the covering member in the direction perpendicular to the inside of the covering member when the test body is viewed from above.

[0216] (Evaluation Criteria)

[0217] A: The immersion distance is 0 mm.

[0218] B: The immersion distance exceeds 0 mm.

[0219] [Table 1]

[0220]

[0221] From Table 1, it was confirmed that both the adhesiveness and the waterproofness were good in Examples 1 to 3. On the other hand, it was confirmed that at least one of the adhesiveness and the waterproofness did not satisfy the evaluation conditions in Comparative Examples 1 to 3.

[0222] Thus, the laminated bodies of the above-mentioned embodiments make the moisture permeability of the covering member and the moisture permeability and tensile strength of the first substrate less than the respective predetermined values, so that even if the laminated body is configured so that the first substrate protrudes from the covering member when the laminated body is viewed from above, the waterproofness and adhesion can be exhibited. Therefore, it can be said that the biosensor involved in this embodiment can be effectively used for measuring electrocardiograms for a long time even if it is adhered to the skin of the subject for a long time (for example, 24 hours).

[0223] In addition, the embodiments of the present invention are as follows, for example.

[0224] <1> A biosensor that is attached to a living body, comprising:

[0225] The sensor body that acquires biological information,

[0226] An electrode connected to the sensor body,

[0227] The sensor body has a storage space and an opening for the storage space, and a moisture permeability of 350 g / (m 2 · days) or less,

[0228] The first substrate is provided on the opening side of the cover member, has a through hole at a position corresponding to the storage space, and has a moisture permeability of 3600 g / (m 2 · days) or less, the tensile strength at a strain of 20% is 5.0 N / 10 mm or less, and

[0229] a second layer member attached to the surface of the first substrate on the opposite side of the cover member so as to expose the electrode and cover the sensor body;

[0230] The first base has an overhanging portion protruding beyond the outer peripheries of the covering member and the second layer member at at least a portion of the outer periphery.

[0231] <2> The biosensor according to <1>, wherein the first substrate includes a polyurethane-based thermoplastic elastomer.

[0232] <3> The biosensor according to <1> or <2>, comprising: a first adhesive layer provided on the surface of the first substrate facing the living body and having the electrode adhered thereto; and

[0233] An upper adhesive layer is used to adhere the cover member and the first substrate.

[0234] <4> The biosensor according to any one of <1> to <3>, wherein the second layer member has a second adhesive layer on a surface opposite to the first substrate.

[0235] <5> The biosensor according to any one of <1> to <4>, wherein an adhesive surface for a living body is formed by the electrode, the first substrate, and the second layer member.

[0236] This application claims priority based on Japanese Patent Application No. 2022-090962 filed with the Japan Patent Office on June 3, 2022, and cites all the contents described in the above application.

[0237] Explanation of symbols

[0238] 1 Biosensor

[0239] 2 Skin

[0240] 101st layer components

[0241] 11 Covering components

[0242] 12 Upper piece

[0243] 12A, 121A, 122A extension

[0244] 12a, 121a, 122a through holes

[0245] 20, 20A, 20B electrodes

[0246] 30 Sensor unit

[0247] 31 Flexible Substrate

[0248] 32 Sensor body

[0249] 33A Connection

[0250] 33A, 33B connection part

[0251] 34 batteries

[0252] 40 Layer 2 Components

[0253] 41 2nd base material

[0254] 42 Adhesive layer for the lower part

[0255] 43 Second adhesive layer

[0256] 111 Protrusion

[0257] 111a Pit

[0258] 112A, 112B flat part

[0259] 121 No.1 Base Material

[0260] 1221st adhesive layer

[0261] 123 Adhesive layer for upper part

[0262] 201A, 201B opposing parts

[0263] 202A, 202B exposed part

[0264] 321 Component mounting unit

[0265] 322 Battery Installation Department

[0266] 331A, 331B wiring

[0267] 332A, 332B terminal part

Claims

1. A biosensor, which is a biosensor attached to a living body, comprising: The sensor body that acquires biological information, an electrode connected to the sensor body, The sensor body has a storage space and an opening of the storage space, and a moisture permeability of 350g / (m 2 · days) or less, The first substrate is provided on the opening side of the cover member, has a through hole at a position corresponding to the storage space, and has a moisture permeability of 3600 g / (m 2 · days) or less, the tensile strength at a strain of 20% is 5.0N / 10mm or less, and a second layer member attached to the surface of the first substrate on the opposite side to the covering member so as to expose the electrode and cover the sensor body; The first base has an overhanging portion protruding beyond the outer peripheries of the cover member and the second layer member at at least a portion of the outer periphery.

2. The biosensor according to claim 1, The first substrate includes a polyurethane-based thermoplastic elastomer.

3. The biosensor according to claim 1, comprising: a first adhesive layer having the electrode attached thereto and disposed on the surface of the first substrate on the biological body side; and An upper adhesive layer for bonding the cover member and the first base material.

4. The biosensor according to claim 1, The second layer member has a second adhesive layer on a surface opposite to the first substrate.

5. The biosensor according to any one of claims 1 to 4, The electrode, the first substrate, and the second layer member form an adhesive surface for a living body.

Images