Biosensors

Abstract

To provide a biosensor that maintains a good adhesive feel while also being waterproof. [Solution] The biosensor according to the present invention is a biosensor attached to a living body, comprising: a sensor body for acquiring biological information; a cover member having a recess in which at least a part of the sensor body is housed and an opening forming the recess; a first substrate provided on the opening side of the cover member and having a through hole at a position corresponding to the recess, and having waterproof and moisture permeable properties; and a second substrate provided on the side of the first substrate opposite to the cover member and having a through hole at a position corresponding to the recess, wherein the cover member has partition wall portions protruding toward the second substrate at at least both ends in its longitudinal direction, and the first substrate is positioned so as not to overlap with the partition wall portions in a plan view.

Description

[Technical Field]

[0001] This invention relates to a biosensor. [Background technology]

[0002] Biosensors are used in medical institutions such as hospitals and clinics, nursing homes, and homes to measure biological information such as electrocardiogram waveforms, pulse waves, electroencephalograms, and electromyograms. Biosensors are equipped with bioelectrodes that come into contact with the body to acquire the subject's biological information. When measuring biological information, the biosensor is attached to the subject's skin, and the electrical signals related to the biological information are acquired by the bioelectrodes, thereby measuring the biological information.

[0003] As such a biosensor, for example, a biosensor has been disclosed that includes a sensor body, electrodes, a first layer member formed by laminating a cover on an upper sheet so as to house the sensor body, and a second layer member attached to the biological side of the first layer member so as to be mounted on the sensor body and exposed on the electrodes (see, for example, Patent Document 1).

[0004] In this biosensor, a first adhesive layer is provided on the surface of the first layer member that faces the body, and a second adhesive layer is provided on the surface of the second layer member that faces the body. While the first and second adhesive layers are attached to the skin, biological information is acquired by electrodes attached to the first adhesive layer that are exposed from the second layer member. [Prior art documents] [Patent Documents]

[0005] [Patent Document 1] Patent No. 6947955 [Overview of the project] [Problems that the invention aims to solve]

[0006] Here, conventional biosensors such as those described in Patent Document 1 are often attached to the biological surface of a subject, such as the skin, and used for long periods of time. Therefore, while the biosensor is attached to the subject, water vapor generated from sweat or water from showering may penetrate and accumulate between the skin and the attachment surface of the biosensor, potentially causing discomfort such as itching or pain to the subject. On the other hand, by increasing the moisture permeability of the components constituting the biosensor, such as the cover or upper sheet, it is possible to make it more difficult for water vapor generated from sweat or water from showering to accumulate between the attachment surface of the biosensor and the skin. However, moisture such as water vapor or water may penetrate into the biosensor, potentially causing condensation on the sensor body.

[0007] Therefore, it is important that the biosensor maintains a good fit by preventing moisture such as water vapor or water from accumulating between the skin and the surface of the biosensor while it is attached to the subject, and that it is waterproof by suppressing water from seeping in from the outside of the cover to the inside.

[0008] One aspect of the present invention aims to provide a biosensor that maintains a good adhesive feel while also being waterproof. [Means for solving the problem]

[0009] One aspect of the present invention is, A biosensor that is attached to a living body, The sensor unit that acquires biometric information, A cover member having a recess in which at least a part of the sensor body is housed, and an opening that forms the recess, A first base material is provided on the opening side of the cover member, has a through hole at a position corresponding to the recess, and is waterproof and breathable, A second base material is provided on the side of the first base material opposite to the cover member and has a through hole at a position corresponding to the recess, Equipped with, The cover member has partition wall portions that protrude toward the second substrate at least at both ends in its longitudinal direction, The first substrate is a biosensor disposed at a position that does not overlap with the partition portion in a plan view.

Advantages of the Invention

[0010] One aspect of the biosensor according to the present invention can maintain a good sticking feeling and has waterproofness.

Brief Description of the Drawings

[0011] [Figure 1] It is a perspective view showing the overall configuration of the biosensor according to an embodiment of the present invention. [Figure 2] It is a plan view showing examples of each component of the biosensor. [Figure 3] It is a longitudinal sectional view of the biosensor, which is a sectional view taken along the line I-I in FIG. 1. [Figure 4] It is a perspective view showing a part of the cover member. [Figure 5] It is an explanatory view showing the configuration of the first substrate. [Figure 6] It is an explanatory view showing a state where the biosensor of FIG. 1 is attached to the chest of a living body.

Modes for Carrying Out the Invention

[0012] Hereinafter, embodiments of the present invention will be described in detail. For ease of understanding of the description, the same reference numerals are given to the same components in each drawing, and duplicate descriptions are omitted. In addition, the scales of each member in the drawings may be different from the actual ones. In this specification, "~" indicating a numerical range means including the numerical values described before and after it as the lower limit value and the upper limit value, unless otherwise specified.

[0013] <Biosensor> The biosensor according to this embodiment will be described. Note that the living body refers to a human body (person), as well as animals such as cows, horses, pigs, chickens, dogs, and cats. The biosensor according to this embodiment can be preferably used for living bodies, particularly for human bodies. In this embodiment, as an example, the case where the living body is a person will be described.

[0014] The biosensor according to this embodiment is an adhesive-type biosensor that measures biological information by being attached to a part of a living body (for example, skin, scalp, or forehead). In this embodiment, we will describe the case in which the biosensor is attached to a person's skin and measures electrical signals (biosignals) related to the person's biological information.

[0015] Figure 1 is a perspective view showing the overall configuration of the biosensor according to this embodiment. The left side of Figure 1 shows the external appearance of the biosensor according to this embodiment, and the right side of Figure 1 shows the biosensor according to this embodiment in a disassembled state. Figure 2 is a plan view showing an example of the components of the biosensor. Figure 3 is a longitudinal cross-sectional view of the biosensor, and is the II cross-sectional view of Figure 1.

[0016] As shown in Figures 1 and 2, the biosensor 1 is a plate-like (sheet-like) member formed in a substantially rectangular shape in a plan view, with both ends in the longitudinal direction formed in an arc shape. As shown in Figures 2 and 3, the biosensor 1 has a first layer member 10, a second layer member 20, an electrode 30, a sensor part 40, and a third layer member 50, and is formed by stacking the first layer member 10, the second layer member 20, the electrode 30, and the third layer member 50 in this order from the first layer member 10 side to the third layer member 50 side. In the biosensor 1, the second layer member 20, the electrode 30, and the third layer member 50 form the surface that is attached to the skin 2, which is a living organism. The biosensor 1 measures electrical signals (biosignals) related to the subject's biological information by attaching the attachment surface to the skin 2 and measuring the potential difference (polarization voltage) between the skin 2 and the electrode 30.

[0017] In Figures 1 to 3, a three-dimensional Cartesian coordinate system with three axes (X-axis, Y-axis, and Z-axis) is used. The short side of the biosensor is the X-axis, the long side is the Y-axis, and the height direction (thickness direction) is the Z-axis. The side of the biosensor 1 that is attached to the living body (subject) (attachment side) is designated as the +Z-axis direction (outside), and the attachment side is designated as the -Z-axis direction. In the following explanation, for convenience of explanation, the +Z-axis direction may be referred to as the upper side or up, and the -Z-axis direction as the lower side or down, but this does not represent a universal up-down relationship.

[0018] Biosignals, for example, are electrical signals that represent electrocardiogram waveforms, electroencephalograms, pulse rates, etc.

[0019] Furthermore, if the biosensor 1 can measure biological signals using a laser, LED light, infrared light, etc., via the sensor unit 40, it does not need to be equipped with electrodes 30.

[0020] The inventors of the present invention investigated the possibility that sweat or external water accumulating between the attachment surface of the biosensor 1 and the skin 2 could penetrate the biosensor and condense on the sensor part 40 and other components installed inside. As a result of diligent investigation, the inventors decided to cover a portion of the side surface of the first base material 121 of the first layer member 10 with a cover member 11 of the first layer member 10, and to give the first base material 121 moisture permeability and waterproofing. As a result, the inventors found that it is possible to make it easier for moisture such as sweat or external water accumulating between the attachment surface of the biosensor 1 and the skin 2 to permeate through the first base material 121, while suppressing water ingress from the outside. Even when the biosensor 1 is attached to the skin 2 of a subject, the biosensor 1 reduces discomfort such as itching and pain to the subject, and water ingress into the biosensor 1 is suppressed. During use, the biosensor 1 maintained its adherence to the skin 2, while also maintaining a good feeling of adhesion and being waterproof.

[0021] [First layer member] As shown in Figures 1 and 2, the first layer member 10 is comprised of a cover member 11 and an upper sheet 12 stacked in that order.

[0022] The first layer member 10 has a rectangular shape in plan view, with a longitudinal direction (Y-axis direction) and a transverse direction (X-axis direction), and may have semicircular curves at both ends in the longitudinal direction.

[0023] (Cover component) As shown in Figure 3, the cover member 11 is located on the outermost side (+Z axis direction) of the biosensor 1 and is adhered to the upper surface of the upper sheet 12. The cover member 11 has a projection 111 that protrudes in a substantially dome shape toward the height direction (+Z axis direction) in Figure 1 at the central part in the longitudinal direction (Y axis direction), flat parts 112A and 112B provided at both ends of the cover member 11 in the longitudinal direction (Y axis direction), and partition parts 113A and 113B that protrude toward the second layer member 20 side from the flat parts 112A and 112B. The side of the cover member 11 that is attached to the projection 111 and the flat parts 112A and 112B is formed flat.

[0024] The protruding portion 111 and the flat portions 112A and 112B are bonded to the upper surface of the upper sheet 12 by the upper adhesive layer 123 of the upper sheet 12, and the partition portions 113A and 113B are bonded to the upper surface of the second layer member 20 by the adhesive 13. The adhesive 13 is not particularly limited as long as it can bond the cover member 11 and the second layer member 20, and a general adhesive may be used. The adhesive 13 preferably has a waterproof function in order to suppress the intrusion of external water.

[0025] The protruding portion 111 has an opening formed on its inner side (attachment side) such that it has a recess 111a formed in a concave shape on the skin 2 side. The recess 111a only needs to be large enough to accommodate at least a part of the sensor portion 40. On the inner side (attachment side) of the protruding portion 111, a storage space S for housing the sensor portion 40 is formed by the recess 111a on the inner surface of the protruding portion 111, the through hole 12a of the first layer member 10, the through hole 20a of the second layer member 20, the electrode 30, and the third layer member 50.

[0026] The cover member 11 may generally be formed using a flexible material such as crosslinked rubber. Examples of crosslinked rubbers include 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. Alternatively, the cover member 11 may be formed by laminating the above-mentioned flexible material onto the surface of a support using a base resin such as polyethylene terephthalate (PET) as a support. By forming the cover member 11 using the above-mentioned flexible material, the sensor part 40, which is placed in the storage space S of the cover member 11, is protected, and the impact applied to the biosensor 1 from above is absorbed, thereby mitigating the impact on the sensor part 40.

[0027] The upper and lower surfaces of the protrusion 111 may be formed flat.

[0028] The thickness of the upper surface and side walls of the protrusion 111 may be greater than the thickness of the flat portions 112A and 112B. This allows the flexibility of the protrusion 111 to be lower than that of the flat portions 112A and 112B, thereby protecting the sensor portion 40 from external forces applied to the biosensor 1.

[0029] The thickness of the upper surface and side walls of the protrusion 111 can be designed as appropriate, for example, 1.5 mm to 3 mm.

[0030] The thickness of the upper surface and side wall of the protrusion 111 refers to the length perpendicular to the surface of the upper surface and side wall of the protrusion 111. The thickness of the upper surface and side wall of the protrusion 111 is, for example, the thickness measured at any point in the cross-section of the upper surface and side wall of the protrusion 111. If multiple measurements are taken at any point, the average value of the thicknesses at these measurement points may be used. The definition and measurement method of thickness are the same for other components of the biosensor 1.

[0031] The flat portions 112A and 112B are provided on both ends of the protruding portion 111 and are formed integrally with the protruding portion 111. The upper and lower surfaces of the flat portions 112A and 112B may be formed flat, similar to the protruding portion 111. The thickness of the flat portions 112A and 112B can be designed as appropriate, for example, 0.5 mm to 1 mm.

[0032] Since the flat portions 112A and 112B are thinner than the protruding portion 111, they are more flexible than the protruding portion 111. Therefore, when the biosensor 1 is attached to the skin 2, the flat portions 112A and 112B easily deform in accordance with the deformation of the skin surface 2 due to body movements such as stretching, bending, and twisting. This makes it possible to alleviate the stress applied to the flat portions 112A and 112B when the surface of the skin 2 deforms, and makes it difficult for the biosensor 1 to peel off the skin 2.

[0033] Furthermore, the outer periphery of the flat portions 112A and 112B may have a shape in which the thickness gradually decreases towards the edge. This makes the outer periphery of the flat portions 112A and 112B more flexible, and improves the wearing comfort when the biosensor 1 is attached to the skin 2 compared to when the thickness of the outer periphery of the flat portions 112A and 112B is not reduced.

[0034] As shown in Figure 4, the partition portions 113A and 113B are formed on both ends of the cover member 11 in the longitudinal direction so as to protrude toward the second layer member 20. In a plan view, the partition portions 113A and 113B may be formed to follow the outer shape of both ends of the cover member 11 in the longitudinal direction. In a plan view, the partition portions 113A and 113B may be formed on the arc-shaped portions at both ends of the cover member 11 in the longitudinal direction.

[0035] The partition walls 113A and 113B may be formed only on a part of the arc-shaped portion, or only on at least a part of both ends in the short direction of the cover member 11, or they may be formed along the entire circumference of the cover member 11.

[0036] As shown in Figure 3, the partition walls 113A and 113B may be in contact with the surface facing the first substrate 121.

[0037] As shown in Figure 4, the heights of the partition walls 113A and 113B can be set appropriately according to the height of the upper sheet 12, and may be set to be approximately the same as the height of the upper sheet 12.

[0038] The thickness of the partition sections 113A and 113B is not particularly limited and may be set appropriately according to the size of the cover member 11 and the upper sheet 12, the thickness of the protruding section 111, the thickness of the flat sections 112A and 112B, etc.

[0039] The hardness (strength) of the cover member 11 can be designed to any size as appropriate, for example, 40 to 70. If the hardness of the cover member 11 is within the above preferred range, when the skin 2 is stretched due to body movement, the upper sheet 12, the second layer member 20, the electrode 30, and the third layer member 50 can easily deform in accordance with the movement of the skin 2 without being affected by the cover member 11. Note that hardness (hardness) refers to Shore A hardness. In this specification, Shore A hardness refers to the value measured in accordance with ISO 7619-1 (JIS K 6253-3:2012). Shore A hardness is a type A durometer hardness measured using a rubber hardness tester (type A durometer) with a type A (cylindrical) indenter. As described in JIS K 6253-3:2012, "Vulcanized rubber 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 cover member 11 may be used as the Shore A hardness of the cover member 11.

[0040] (Upper sheet) As shown in Figure 3, the upper sheet 12 is attached to the lower surface of the cover member 11. In a plan view, the upper sheet 12 has approximately the same width as the cover member 11, and its outer shape is shorter in length by the amount of the partition walls 113A and 113B of the cover member 11.

[0041] The upper sheet 12 has a through hole 12a at a position opposite to the protrusion 111 of the cover member 11. The through hole 12a allows the sensor body 42 of the sensor unit 40 to be housed in the storage space S formed by the recess 111a on the inner surface of the protrusion 111, the through hole 12a of the first layer member 10, the through hole 20a of the second layer member 20, the electrode 30, and the third layer member 50, without being obstructed by the upper sheet 12.

[0042] The upper sheet 12 is formed so as not to overlap with the partition walls 113A and 113B in a plan view, and is positioned so as not to overlap with the partition walls 113A and 113B in a plan view. The upper sheet 12 may be formed so that both longitudinal surfaces of the upper sheet 12 are in contact with the cover member 11.

[0043] The upper sheet 12 includes a first base material 121, a first adhesive layer 122 on which the electrode 30 is attached to one side of the first base material 121 facing the electrode 30, and an upper adhesive layer 123 provided on the side of the first base material 121 opposite to the side facing the electrode 30.

[0044] ((1st base material)) The first base material 121 is provided on the attachment side, which is the opening side of the cover member 11. The first base material 121 is formed in a sheet shape and, in a plan view, is positioned so as not to overlap with the partition walls 113A and 113B, and is formed so as not to overlap with the partition walls 113A and 113B. The upper sheet 12 may be formed so that both longitudinal surfaces of the upper sheet 12 are in contact with the cover member 11.

[0045] The first base material 121 may be waterproof, breathable, and flexible. The flexibility, waterproof, and breathable properties of the first base material 121 allow it to stretch easily when the biosensor 1 is in contact with the skin 2, maintaining contact between the biosensor 1 and the skin 2, while also suppressing the penetration of liquid into the gap between the first base material 121 and the first adhesive layer 122 or the upper adhesive layer 123. Furthermore, water vapor from sweat and other sources generated from the skin 2 can be released to the outside of the biosensor 1 via the first base material 121. This makes it easier for the upper sheet 12 to maintain adhesive durability.

[0046] The first substrate 121 only needs to be flexible, waterproof, and breathable, and may be a porous body having a porous structure. If the first substrate 121 is a porous body, it is preferable because it makes it easier to release water vapor from sweat etc. generated from the skin 2 to which the biosensor 1 is attached to the outside of the biosensor 1 through the first substrate 121.

[0047] The porous material may have a cellular structure such as open-cell, closed-cell, or semi-closed-cell. That is, the porous material may be a porous material manufactured by foam molding that forms open-cells (a porous material having an open-cell structure), a porous material manufactured by foam molding that forms closed-cells (a porous material having a closed-cell structure), or a porous material manufactured by foam molding that forms semi-closed cells (a porous material having a semi-closed-cell structure). Examples of porous materials that can be used include foamed sheets and nonwoven fabric sheets.

[0048] As the material for forming the first substrate 121, for example, a flexible material such as a thermoplastic resin or thermoplastic elastomer can be used, such as a polyurethane resin, polystyrene resin, polyolefin resin, silicone resin, acrylic resin, vinyl chloride resin, or polyester resin.

[0049] Examples of thermoplastic elastomers include polyurethane-based thermoplastic elastomers, polystyrene-based thermoplastic elastomers, polyolefin-based thermoplastic elastomers, polyester-based thermoplastic elastomers, polyvinyl chloride-based thermoplastic elastomers, polyamide-based thermoplastic elastomers, nitrile-based thermoplastic elastomers, nylon-based thermoplastic elastomers, fluororubber-based thermoplastic elastomers, polybutadiene-based thermoplastic elastomers, ethylene vinyl acetate-based thermoplastic elastomers, chlorinated polyethylene-based thermoplastic elastomers, styrene-butadiene block copolymers or their hydrogenated derivatives, styrene-isoprene block copolymers or their hydrogenated derivatives, and the like. These may be used individually or in combination of two or more. Among these, polyurethane-based thermoplastic elastomers are preferred.

[0050] If the first substrate 121 is a porous material, specifically, a foamed sheet such as FOLEC manufactured by Inoac Corporation, or a nonwoven fabric sheet such as the EW adhesive patch manufactured by Nippon Vilene, may be used.

[0051] The waterproofness of the first substrate 121 can be evaluated from the magnitude of its breaking strength. The greater the breaking strength of the first substrate 121, the lower its waterproofness tends to be. Therefore, the greater the breaking strength of the first substrate 121, the lower its waterproofness can be evaluated.

[0052] The ratio of the breaking strength of the first base material 121 in the longitudinal direction to the breaking strength of the first base material 121 in the short direction is preferably 1.05 to 10.00, more preferably 1.30 to 4.70, and even more preferably 1.50 to 3.00.

[0053] The longitudinal breaking strength of the first substrate 121 is preferably 1.0 MPa to 80.0 MPa, more preferably 2.0 MPa to 75.0 MPa, and even more preferably 2.5 MPa to 70.0 MPa.

[0054] The breaking strength of the first substrate 121 in the short direction is preferably 0.1 MPa to 60.0 MPa, more preferably 0.5 MPa to 55 MPa, and even more preferably 1.5 MPa to 30 MPa.

[0055] Furthermore, the waterproofness of the first substrate 121 can be evaluated based on the water infiltration distance of the first substrate 121. The greater the water infiltration distance of the first substrate 121, the lower the waterproofness of the first substrate 121 tends to be; therefore, the greater the water infiltration distance of the first substrate 121, the lower the waterproofness of the first substrate 121 can be evaluated.

[0056] As a method for measuring the immersion distance of the first base material 121, for example, a laminate may be used as a test specimen, in which the cover member 11 is laminated onto the first base material 121 having an outer diameter larger than the outer diameter of the cover member 11 via an adhesive, so that the first base material 121 has an overhang portion that extends beyond the cover member 11 in a plan view. Water is supplied from a water supply device such as a watering nozzle to the upper surface of the overhang portion of the first base material 121 in a plan view of the biosensor 1. The water supply conditions are not particularly limited and may be set appropriately according to the size, shape, etc., of the first base material 121. For example, the water supply conditions may be a water pressure of approximately 30 kPa, a water flow rate of approximately 12.5 L / min, and a supply time of approximately 3 minutes. The water supply method can be any method that can supply water at a predetermined flow rate for a certain period of time toward the overhang portion on the upper surface of the first base material 121. As for the method of supplying water, for example, it may be a method in which water is sprayed (misted) in a mist toward the upper surface of the protruding part of the first substrate 121 using a watering spray, watering nozzle, etc., or it may be a method in which water with velocity is sprayed (jet) toward the upper surface of the protruding part of the first substrate 121 from a spray nozzle, etc.

[0057] The waterproofness of the first substrate 121 may be determined by whether or not the distance of water ingress from the boundary between the protruding portion of the first substrate 121 and the cover member 11 to the inside, in a plan view of the biosensor 1, is less than or equal to a predetermined value (for example, 3 mm).

[0058] The immersion distance refers to the length in the direction perpendicular to the inside of the first substrate 121 relative to the outer surface (side surface) of the first substrate 121, in a plan view of the biosensor 1.

[0059] The longitudinal direction of the first base material 121 may be the flow direction (MD direction) of the material forming the first base material 121 during its formation, and the transverse direction may be the width direction (TD direction) of the material forming the first base material 121 during its formation. When the first base material 121 is formed from a porous body, generally a porous body formed into a sheet using the material forming the first base material 121 is used. In this case, anisotropy tends to occur in the shape of the pores contained inside the first base material 121, resulting in different waterproof properties.

[0060] When the first base material 121 is formed from a porous material, if the material forming the first base material 121 is formed into a sheet to create a porous material, as shown in Figure 5, the holes formed inside the porous material are easily stretched in the MD direction, deformed into a roughly elliptical shape, and adjacent holes easily connect to each other. On the other hand, as the holes formed inside the porous material are stretched in the MD direction, the holes formed inside the porous material tend to become smaller in the TD direction, making it difficult for adjacent holes to connect to each other, and they tend to exist individually. Generally, the longitudinal direction of the first base material 121 is formed and processed to align with the MD direction. Therefore, if the first base material 121 is formed such that its longitudinal direction is the MD direction and its short direction is the TD direction, the waterproofing performance will be lower in the longitudinal direction of the first base material 121, and higher in the short direction than in the longitudinal direction. Therefore, by covering both longitudinal surfaces of the first substrate 121 with partition walls 113A and 113B, water ingress from areas of the first substrate 121 with weak waterproofing properties is effectively suppressed.

[0061] The first base material 121 may be configured to have higher elasticity than the cover member 11.

[0062] The moisture permeability of the first substrate 121 may be higher than that of the cover member 11, but the moisture permeability of the first substrate 121 should be 100 g / (m 2 • day) ~ 5000g / (m 2 It is preferable that the moisture permeability of the first substrate 121 be 100 g / (m²). 2 • day) ~ 5000g / (m 2 By doing this (day), the first substrate 121 can allow water vapor that has entered from one side to pass through the first substrate 121 and be stably released from the other side.

[0063] The thickness of the first substrate 121 can be appropriately set depending on the type of the first substrate 121, but it is preferable that it be 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 amount of irritation caused by the outer periphery of the cover member 11 coming into contact with the skin 2. The thickness of the first substrate 121 may be, for example, 10 μm to 1.5 mm.

[0064] When the first base material 121 is formed from a porous material such as a foamed sheet or a nonwoven fabric sheet, the thickness of the first base material 121 is preferably, for example, 0.5 mm to 1.5 mm, and more preferably about 1 mm.

[0065] The first base material 121 has a through hole 121a at a position opposite to the protrusion 111 of the cover member 11. By providing the first adhesive layer 122 and the upper adhesive layer 123 on the surface of the first base material 121 other than the through hole 121a, through holes 122a and 123a can also be formed in the first adhesive layer 122 and the upper adhesive layer 123. Through holes 121a, 122a and 123a form the through hole 12a.

[0066] ((1st adhesive layer)) As shown in Figure 3, the first adhesive layer 122 is provided attached to one side of the first substrate 121 that faces the second layer member 20. The first adhesive layer 122 is located on the biological side (-Z axis direction) of the first substrate 121 and has the function of bonding the first substrate 121 and the second substrate 21.

[0067] The first adhesive layer 122 may be permeable to moisture. This allows water vapor from sweat, etc., generated from the skin 2 to which the biosensor 1 is attached to escape to the first substrate 121 via the first adhesive layer 122, and then to the outside of the biosensor 1 from the first substrate 121. If the first substrate 121 is formed of a porous material having a cellular structure as described above, water vapor can be released to the outside of the biosensor 1 via the first adhesive layer 122. This prevents water vapor from sweat, etc., or moisture such as water from the outside from accumulating at the interface between the first layer member 10 and the second layer member 20. As a result, it is possible to prevent the adhesive strength of the first adhesive layer 122 from weakening due to moisture accumulated at the interface between the first layer member 10 and the second layer member 20, and to prevent a decrease in adhesion to the second layer member 20.

[0068] The moisture permeability of the first adhesive layer 122 is, for example, 1 g / (m²). 2 It is preferable that the moisture permeability of the first adhesive layer 122 is 10,000 g / (m²). 2 The moisture permeability of the first adhesive layer 122 may be 1 g / (m²). 2 If the duration is (i.e., 1 day or more), when the first adhesive layer 122 is attached to the second layer member 20, water vapor from sweat transmitted from the second layer member 20 or moisture such as external water can be transmitted to the outside, thereby reducing the load on the second layer member 20.

[0069] As the material for forming the first adhesive layer 122, a pressure-sensitive adhesive material may be used. Examples of pressure-sensitive adhesive materials include acrylic adhesives and silicone adhesives, with acrylic adhesives being preferred.

[0070] The first adhesive layer 122 may be a double-sided adhesive tape formed from the above material.

[0071] The first adhesive layer 122 may have a wavy pattern (web pattern) formed on its surface, where recesses that are thinner than other parts (or have zero thickness) are repeatedly and alternately arranged. That is, the recesses may be non-adhesive parts without adhesive, and the first adhesive layer 122 may have a web pattern formed on its surface, where adhesive-forming parts with adhesive and non-adhesive parts are alternately formed. As the first adhesive layer 122, for example, a double-sided adhesive tape with a web pattern formed on its surface may be used. By having a web pattern on its surface, the first adhesive layer 122 can have adhesive adhere to the convex parts of the surface and their surroundings, while not adhering to the recesses of the surface and their surroundings. Therefore, since there are parts on the surface of the first adhesive layer 122 that have adhesive and parts that do not have adhesive, the adhesive can be scattered on the surface of the first adhesive layer 122. The moisture permeability of the first adhesive layer 122 tends to increase as the adhesive is thinner. Therefore, the first adhesive layer 122 has a web pattern formed on its surface, and the adhesive is partially thinner in certain areas, which improves moisture permeability while maintaining adhesive strength compared to when the web pattern is not formed.

[0072] The thickness of the first adhesive layer 122 can be set arbitrarily as appropriate, for example, to 10 μm to 300 μm. If the thickness of the first adhesive layer 122 is between 10 μm and 300 μm, the biosensor 1 can be made thinner.

[0073] The adhesive strength of the first adhesive layer 122 can be set arbitrarily as appropriate; for example, it may be 3.0 N / 10 mm to 20 N / 10 mm for a bakelite plate. If the adhesive strength of the first adhesive layer 122 is 3.0 N / 10 mm to 20 N / 10 mm, the first adhesive layer 122 can maintain its adhesion to the surface of the second layer member 20.

[0074] ((Top adhesive layer)) As shown in Figure 3, the upper adhesive layer 123 is attached to the surface of the first substrate 121 opposite to the surface facing the electrode 30. The upper adhesive layer 123 is attached to the upper surface of the first substrate 121 at a position corresponding to the flat surface on the side (-Z axis direction) where the cover member 11 is attached, and has the function of bonding the first substrate 121 and the cover member 11.

[0075] A biocompatible material is used to form the upper adhesive layer 123. Examples of biocompatible materials include acrylic adhesives, silicone adhesives, and silicone tapes, with silicone adhesives being preferred.

[0076] The thickness of the upper adhesive layer 123 can be set as appropriate, for example, from 10 μm to 300 μm.

[0077] [Second layer member] As shown in Figure 3, the second layer member 20 is provided on the side of the first base material 121 opposite to the cover member 11, and may be attached to the lower surface, which is the side of the first adhesive layer 122 that is attached (in the -Z axis direction). In a plan view, the second layer member 20 is formed to have the same outer shape as the cover member 11 and the first base material 121.

[0078] The second layer member 20 has a through hole 20a at a position opposite to the recess 111a of the cover member 11. Through the through hole 20a, the sensor body 42 of the sensor unit 40 is housed in the storage space S formed by the recess 111a on the inner surface of the cover member 11, the through hole 12a, the through hole 20a, the electrode 30, and the third layer member 50, without being obstructed by the second layer member 20.

[0079] The second layer member 20 has a second base material 21 and a second adhesive layer 22 on one side of the second base material 21 facing the electrode 30 to which the electrode 30 is attached. If the upper sheet 12 does not have a first adhesive layer 122, the second layer member 20 may have an adhesive layer on the side of the second base material 21 facing the first layer member 10 (upper surface) for attachment to the first layer member 10.

[0080] (Second base material) As the material for forming the second base material 21, for example, flexible materials such as thermoplastic resins and thermoplastic elastomers such as polyurethane resins, polystyrene resins, polyolefin resins, silicone resins, acrylic resins, vinyl chloride resins, and polyester resins can be used.

[0081] Examples of thermoplastic elastomers include polyurethane-based thermoplastic elastomers, polystyrene-based thermoplastic elastomers, polyolefin-based thermoplastic elastomers, polyester-based thermoplastic elastomers, polyvinyl chloride-based thermoplastic elastomers, polyamide-based thermoplastic elastomers, nitrile-based thermoplastic elastomers, nylon-based thermoplastic elastomers, fluororubber-based thermoplastic elastomers, polybutadiene-based thermoplastic elastomers, ethylene vinyl acetate-based thermoplastic elastomers, chlorinated polyethylene-based thermoplastic elastomers, styrene-butadiene block copolymers or their hydrogenated derivatives, styrene-isoprene block copolymers or their hydrogenated derivatives, and the like. These may be used individually or in combination of two or more. Among these, polyurethane-based thermoplastic elastomers are preferred.

[0082] When the second base material 21 is formed using a polyurethane thermoplastic elastomer, it is preferable that the second base material 21 is a urethane sheet made of a polyurethane thermoplastic elastomer. Specifically, as the second base material, a polyurethane sheet such as Esmer URS manufactured by Nippon Matai may be used.

[0083] (2nd adhesive layer) As shown in Figure 3, the second adhesive layer 22 is provided attached to one side of the second substrate 21 that faces the electrode 30. The second adhesive layer 22 is located on the biological side (-Z axis direction) of the first substrate 121 and has the functions of bonding the first layer member 10 to the second substrate 21, bonding the skin 2 to the second substrate 21, and bonding the second substrate 21 to the electrode 30.

[0084] The second adhesive layer 22 may have moisture permeability. Thereby, as will be described later, water vapor generated from the skin 2 to which the biosensor 1 is attached can escape to the second base material 21 through the second adhesive layer 22 and be released from the second base material 21 to the outside of the biosensor 1 and the first layer member 10. Thereby, it is possible to suppress moisture such as water vapor due to sweat or external water from accumulating at the interface between the skin 2 on which the biosensor 1 is worn and the second layer member 20. As a result, it is possible to suppress the adhesive force of the second adhesive layer 22 from being weakened due to the moisture accumulated at the interface between the skin 2 and the second adhesive layer 22 and the biosensor 1 from peeling off the skin 2.

[0085] The moisture permeability of the second adhesive layer 22 is not particularly limited and may be set as appropriate. For example, similar to the first adhesive layer 122, it may be 1 g / (m 2 ·day) or more, and may be 10000 g / (m 2 ·day) or less. If the moisture permeability of the second adhesive layer 22 is 1 g / (m 2 ·day) or more, when the second adhesive layer 22 is attached to the skin 2, moisture such as water vapor due to sweat or external water transmitted from the second adhesive layer 22 can be permeated outward, so that the load on the skin 2 can be reduced.

[0086] As the material for forming the second adhesive layer 22, a material having pressure-sensitive adhesiveness may be used, similar to the first adhesive layer 122. A material having pressure-sensitive adhesiveness may be the same material as the first adhesive layer 122.

[0087] The second adhesive layer 22 may be a double-sided adhesive tape formed of the material forming the first adhesive layer 122 described above.

[0088] The second adhesive layer 22 may have a wavy pattern (web pattern) formed on its surface, in which recesses that are thinner than other parts (or have zero thickness) are repeatedly and alternately arranged. The configuration of the web pattern is the same as that of the first adhesive layer 122 described above, so details are omitted. By forming a web pattern on the surface of the second adhesive layer 22 and having parts where the adhesive is partially thinner, the second adhesive layer 22 can improve moisture permeability while maintaining adhesive strength compared to when the web pattern is not formed.

[0089] The thickness of the second adhesive layer 22 can be set arbitrarily as appropriate, and like the first adhesive layer 122, it may be, for example, 10 μm to 300 μm. If the thickness of the second adhesive layer 22 is 10 μm to 300 μm, the biosensor 1 can be made thinner.

[0090] The adhesive strength of the second adhesive layer 22 can be set arbitrarily as appropriate; for example, it may be set to 3.0 N / 10 mm to 20 N / 10 mm for a bakelite plate. If the adhesive strength of the second adhesive layer 22 is 3.0 N / 10 mm to 20 N / 10 mm, the second adhesive layer 22 constitutes a part of the surface on which the biosensor 1 attaches to the skin 2, thereby improving the adhesion of the biosensor 1 to the body.

[0091] [electrode] As shown in Figure 3, the electrode 30 is attached to the lower surface of the first adhesive layer 122, which is the attachment side (-Z axis direction), with a portion of the electrode 30 on the sensor body 42 side connected to wirings 431A and 431B, sandwiched between the first adhesive layer 122 and the lower adhesive layer 52. The portion of the electrode 30 not sandwiched between the first adhesive layer 122 and the lower adhesive layer 52 is in contact with the living body. When the biosensor 1 is attached to the skin 2, the electrode 30 comes into contact with the skin 2, allowing for the detection of a biological signal. Alternatively, the electrode 30 may be embedded in the second substrate 21 in a state where it is exposed and can come into contact with the skin 2.

[0092] As shown in Figure 2, the electrode 30 may be positioned below the region including the connection portions 43A and 43B in a plan view of the biosensor 1.

[0093] The electrode 30 is composed of a pair of electrodes 30A and 30B. As shown in Figure 3, electrode 30A is positioned on the left side of the figure, and electrode 30B is positioned on the right side of the figure. One end (inside) of electrode 30A in its longitudinal direction (Y-axis direction) is in contact with terminal portion 432A, and one end (inside) of electrode 30B in its longitudinal direction (Y-axis direction) is in contact with terminal portion 432B. The pair of electrodes 30A and 30B have substantially the same shape.

[0094] Furthermore, one end of electrode 30A that contacts terminal portion 432A of sensor portion 40 is designated as opposing portion 301A, and one end of electrode 30B that contacts terminal portion 432B of sensor portion 40 is designated as opposing portion 301B. The portion of electrode 30A that does not contact terminal portion 432A (the other end (outside) in the longitudinal direction (Y-axis direction)) is designated as exposed portion 302A, and the portion of electrode 30B that does not contact terminal portion 432B (the other end (outside) in the longitudinal direction (Y-axis direction)) is designated as exposed portion 302B.

[0095] The electrode 30 may have any shape, such as a sheet.

[0096] The shape of electrode 30 in plan view is not particularly limited and may be designed to any shape as appropriate depending on the application. As shown in Figure 2, electrodes 30A and 30B, in plan view, may have opposing portions 301A and 301B, which are one end (one side) in the longitudinal direction of the adhesive electrode for acquiring biosignals, formed in a rectangular shape, and exposed portions 302A and 302B, which are the other end (the other side) in the longitudinal direction, formed in an arc shape.

[0097] The electrode 30 can be formed using a cured product of a conductive composition containing a conductive polymer and a binder resin, a metal, an alloy, or the like. In particular, from the viewpoint of biosafety, such as preventing allergic reactions when the electrode 30 is applied to a living organism, it is preferable to form the electrode 30 using a cured product of a conductive composition. The electrode 30 may also be an electrode sheet in which the cured product of the conductive composition is formed into a sheet shape.

[0098] Examples of conductive polymers that can be used include polythiophene-based conductive polymers, polyaniline-based conductive polymers, polyacetylene-based conductive polymers, polypyrrole-based conductive polymers, polyphenylene-based conductive polymers and their derivatives, as well as composites thereof. These may be used individually or in combination of two or more. Among these, it is preferable to use a composite in which polythiophene is doped with polyaniline as a dopant. Among the composites of polythiophene and polyaniline, it is even more preferable to use PEDOT / PSS, which is obtained by doping poly(3,4-ethylenedioxythiophene) (also called PEDOT) as the polythiophene and polystyrene sulfonic acid (poly4-styrene sulfonate; PSS) as the polyaniline, because it has a lower contact impedance with living organisms and higher conductivity.

[0099] The binder resin can be a water-soluble polymer or a water-insoluble polymer. As a water-soluble polymer, hydroxyl group-containing polymers such as polyvinyl alcohol (PVA) and modified PVA can be used.

[0100] The conductive composition may contain various common additives such as crosslinking agents and plasticizers in appropriate proportions. Examples of crosslinking agents include aldehyde compounds such as sodium glyoxylate. Examples of plasticizers include glycerin, ethylene glycol, and propylene glycol.

[0101] Common metals and alloys such as Au, Pt, Ag, Cu, and Al can be used as metals and alloys.

[0102] The thickness of the electrode 30 may be any height as appropriate, for example, 10 μm to 100 μm. When the thickness of the electrode 30 is within the above preferred range, the electrode 30 can have sufficient strength and flexibility, as well as conductivity stability when deformed.

[0103] The area of ​​the electrode 30 can be set to any size appropriate to the size of the biosensor 1, for example, 2.0 cm². 2 ~5.0cm2 This is acceptable. The area of ​​electrode 30 is 2.0 cm². 2 ~5.0cm 2 Therefore, the electrode 30 can have sufficient conductivity stability. The method for measuring the area of ​​the electrode 30 is not particularly limited, and general measurement methods such as calculating it from a plan view image of the electrode 30 can be used.

[0104] (Sensor unit) As shown in Figure 2, the sensor unit 40 includes a flexible substrate 41, a sensor body 42, and connection parts 43A and 43B connected to the sensor body 42.

[0105] The flexible substrate 41 is a resin substrate on which various components for acquiring biological information are mounted. The flexible substrate 41 has a sensor body 42 and connection parts 43A and 43B arranged on it.

[0106] The sensor body 42 has a component mounting section 421 which is a control unit and a battery mounting section 422, and acquires biological information.

[0107] The component mounting section 421 has various components mounted on the flexible substrate 41, including a CPU and integrated circuit that process biological signals acquired from the living body to generate biological signal data, a switch SW for activating the biological sensor 1, a flash memory for storing biological signals, a light-emitting element, etc., and acquires biological information. Examples of circuits using the various components are omitted. The component mounting section 421 operates using power supplied from the battery 44 mounted in the battery mounting section 422.

[0108] The component mounting section 421 only needs to be capable of measuring biological signals. For example, it may be a device comprising an irradiation unit (not shown) that irradiates the skin 2 with infrared light or the like, and a detection unit (not shown) that detects the infrared light or the like reflected from the skin 2 to measure biological signals.

[0109] The component mounting section 421 transmits data via wired or wireless connection to external devices such as an operation confirmation device to check initial operation and a reading device to read biological information from the biosensor 1.

[0110] The battery mounting section 422 is located between the connection section 43A and the component mounting section 421, and supplies power to the integrated circuit and other components mounted on the component mounting section 421. As shown in Figure 2, a battery 44 is mounted in the battery mounting section 422.

[0111] The connection sections 43A and 43B each have wiring 431A and 431B connected to the sensor body 42 in the longitudinal direction (Y-axis direction) of the sensor body 42, and terminal sections 432A and 432B provided at the ends of the wiring 431A and 431B and connected to the electrode 30.

[0112] As shown in Figure 3, one end of wiring 431A and 431B is connected to the electrode 30, respectively. As shown in Figure 3, the other end of wiring 431A is connected to a switch SW or the like mounted on the component mounting section 421 along the outer circumference of the sensor body 42. The other end of wiring 431B is connected to a switch SW or the like mounted on the component mounting section 421.

[0113] Terminals 432A and 432B are arranged such that one end is connected to wiring 431A and 431B, and the upper surface of the other end is in contact with the electrode 30, while being sandwiched between the second layer member 20 and the third layer member 50.

[0114] Battery 44 can be any known battery. For example, a coin cell battery such as a CR2025 can be used as battery 44.

[0115] [Third layer member] As shown in Figure 3, the third layer member 50 is provided on the side where the electrode 30 and sensor unit 40 are attached, and serves as a support substrate for installing the sensor unit 40, as well as forming a part of the surface that attaches to the skin 2. As shown in Figures 1 and 2, the external shape of both sides of the third layer member 50 in the width direction (X-axis direction) may be substantially the same as the external shape of both sides of the first layer member 10 in the width direction (X-axis direction). The length of the third layer member 50 (Y-axis direction) is shorter than the length (Y-axis direction) of the cover member 11 and the upper sheet 12. As shown in Figure 3, both ends of the third layer member 50 in the longitudinal direction are positioned to sandwich the wiring 431A and 431B of the sensor unit 40 between the third layer member 50 and the upper sheet 12, and overlap with a part of the electrode 30.

[0116] The third layer member 50 has a third base material 51, a lower adhesive layer 52 provided on the upper surface of the third base material 51, and a third adhesive layer 53 provided on the lower surface of the third base material 51. The third base material 51, the lower adhesive layer 52, and the third adhesive layer 53 may be formed in the same shape in a plan view. The third adhesive layer 53 of the third layer member 50 and the electrode 30 form an adhesive surface to be attached to the skin 2. Depending on the area of ​​the electrode 30 and the third adhesive layer 53, and depending on the position of the adhesive surface, the waterproofness and breathability and adhesiveness can be made to differ. Thus, depending on the area of ​​the adhesive surface of the third adhesive layer 53, the waterproofness and breathability, as well as the adhesiveness, can be made to differ.

[0117] (Third base material) The third base material 51 can be formed using a flexible resin having appropriate elasticity, flexibility, and toughness. Examples of materials that can be used to form the third base material 51 include polyester resins such as polyethylene terephthalate (PET), polybutylene terephthalate, polytrimethylene terephthalate, polyethylene naphthalate, and polybutylene naphthalate; acrylic resins such as polyacrylic acid, polymethacrylic acid, polymethyl polyacrylate, polymethyl methacrylate (PMMA), polyethyl polymethacrylate, and polybutylene 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 resins; polyurethane resins; silicone resins; and polyvinyl chloride resins such as polyvinyl chloride and vinyl acetate copolymer resins. Among these, polyolefin resins and PET are preferably used. These thermoplastic resins have waterproof properties that do not allow moisture and water vapor to pass through (low moisture permeability). Therefore, by forming the third substrate 51 using these thermoplastic resins, when the biosensor 1 is attached to the skin 2 of a living body, it is possible to prevent moisture such as water vapor from sweat generated from the skin 2 or external water from passing through the third substrate 51 and entering the flexible substrate 41 side of the sensor part 40.

[0118] The third substrate 51 is preferably formed in a flat plate shape because the sensor portion 40 is installed on its upper surface via the lower adhesive layer 52.

[0119] The thickness of the third substrate 51 can be arbitrarily selected as appropriate, for example, from 1 μm to 300 μm.

[0120] (Bottom adhesive layer) As shown in Figure 3, the lower adhesive layer 52 is provided on the upper surface of the third base material 51 on the cover member 11 side (+Z axis direction), and the sensor part 40 is adhered to it. Both longitudinal ends of the lower adhesive layer 52 of the third layer member 50 are provided in positions facing the opposing portions 301A and 301B of the electrode 30. This allows the opposing portions 301A and 301B of the electrode 30 and the terminal portions 432A and 432B to be pressed and sandwiched between the upper sheet 12 and the third layer member 50, thereby enabling electrical contact between the electrode 30 and the terminal portions 432A and 432B. The lower adhesive layer 52 can be made of the same material as the third adhesive layer 53, which will be described later, so details are omitted. Note that the lower adhesive layer 52 is not necessarily required and may be omitted.

[0121] (3rd adhesive layer) As shown in Figure 3, the third adhesive layer 53 is provided on the lower surface of the third substrate 51 on the attachment side (-Z axis direction) and is the layer that comes into contact with the living body.

[0122] The third adhesive layer 53 preferably has pressure-sensitive adhesive properties. By having pressure-sensitive adhesive properties, the biosensor 1 can be easily attached to the skin 2 of a living body by pressing it against the skin 2.

[0123] The material of the third adhesive layer 53 is not particularly limited as long as it is a pressure-sensitive adhesive material, and biocompatible materials are also available. Examples of materials for forming the third adhesive layer 53 include acrylic pressure-sensitive adhesives and silicone pressure-sensitive adhesives. Preferably, an acrylic pressure-sensitive adhesive is used.

[0124] Acrylic pressure-sensitive adhesives preferably contain an acrylic polymer as their main component. The acrylic polymer can function as a pressure-sensitive adhesive component. As the acrylic polymer, a polymer can be used that contains (meth)acrylic acid esters such as isononyl acrylate and methoxyethyl acrylate as the main component, and polymers obtained by polymerizing monomer components that can copolymerize with (meth)acrylic acid esters such as acrylic acid as optional components.

[0125] The acrylic pressure-sensitive adhesive preferably further contains a carboxylic acid ester. The carboxylic acid ester functions as a pressure-sensitive adhesive strength modifier that reduces the pressure-sensitive adhesive strength of the acrylic polymer and adjusts the pressure-sensitive adhesive strength of the third adhesive layer 53. The carboxylic acid ester can be one that is compatible with the acrylic polymer. Examples of carboxylic acid esters include triglycerides.

[0126] Acrylic pressure-sensitive adhesives may contain a crosslinking agent as needed. The crosslinking agent is a crosslinking component that crosslinks the acrylic polymer. Examples of crosslinking agents include polyisocyanate compounds (polyfunctional isocyanate compounds), epoxy compounds, melamine compounds, peroxide compounds, urea compounds, metal alkoxide compounds, metal chelate compounds, metal salt compounds, carbodiimide compounds, oxazoline compounds, aziridine compounds, and amine compounds. Among these, polyisocyanate compounds are preferred. These crosslinking agents may be used alone or in combination.

[0127] The third adhesive layer 53 preferably has excellent biocompatibility. For example, when the third adhesive layer 53 is subjected to a keratin exfoliation test, the keratin exfoliation area ratio is preferably 0% to 50%. If the keratin exfoliation area ratio is within the range of 0% to 50%, the load on the skin 2 can be suppressed even when the third adhesive layer 53 is applied to the skin 2.

[0128] The third adhesive layer 53 preferably has moisture permeability. This allows water vapor and other substances generated from the skin 2 to which the biosensor 1 is attached to escape to the upper sheet 12 side through the third adhesive layer 53. Furthermore, as will be described later, the upper sheet 12 has a cellular structure, which allows water vapor to be released to the outside of the biosensor 1 through the third adhesive layer 53. This prevents moisture such as water vapor from sweat or external water from accumulating at the interface between the skin 2 to which the biosensor 1 is attached and the third adhesive layer 53. As a result, the adhesive strength of the third adhesive layer 53 is weakened by the moisture accumulated at the interface between the skin 2 and the third adhesive layer 53, which prevents the biosensor 1 from peeling off the skin.

[0129] The moisture permeability of the third adhesive layer 53 is, for example, 300 g / (m²). 2 •day)~10000g / (m 2 It is preferable that the moisture permeability of the third adhesive layer 53 is within the above preferred range. If the third adhesive layer 53 is attached to the skin 2, water vapor from sweat generated from the skin 2 can be appropriately permeated from the third adhesive layer 53 to the outside, thereby reducing the burden on the skin 2.

[0130] The thickness of the third adhesive layer 53 can be arbitrarily selected as appropriate, and is preferably between 10 μm and 300 μm. If the thickness of the third adhesive layer 53 is between 10 μm and 300 μm, the biosensor 1 can be made thinner.

[0131] As shown in Figures 1 and 2, when the biosensor 1 is not in use, it is preferable to attach the release liner 60 to the adhesive surface of the electrode 30 and the third substrate 51 to protect the electrode 30 and the third layer member 50 until use. When in use, the release liner 60 is peeled off from the electrode 30 and the third layer member 50, and the adhesive surface of the biosensor 1 is attached to the skin 2. By keeping the release liner 60 attached to the adhesive surface, the adhesive strength of the electrode 30 and the third layer member 50 can be maintained even if the biosensor 1 is stored for a long period of time. Therefore, when in use, the release liner 60 is peeled off from the third layer member 50 and the electrode 30, allowing the adhesive surface to be securely attached to the skin 2 for use.

[0132] The method for manufacturing the biosensor 1 is not particularly limited and can be manufactured using any method as appropriate. An example of a method for manufacturing the biosensor 1 will be described below.

[0133] Prepare the first layer member 10, the second layer member 20, the electrode 30, the sensor unit 40, and the third layer member 50 as shown in Figures 1 and 2. The first layer member 10, the second layer member 20, the electrode 30, the sensor unit 40, and the third layer member 50 are not particularly limited as long as they can be manufactured using any manufacturing method that is appropriate for them.

[0134] After preparing the first layer member 10, second layer member 20, electrode 30, sensor unit 40, and third layer member 50 that constitute the biosensor 1 shown in Figure 1, the sensor unit 40 is placed on top of the third layer member 50. Then, the first layer member 10, second layer member 20, electrode 30, sensor unit 40, and third layer member 50 are stacked in that order from the first layer member 10 side toward the third layer member 50 side. This results in the biosensor 1 shown in Figure 1.

[0135] Figure 6 is an explanatory diagram showing the biosensor 1 from Figure 1 attached to the chest of subject P. As shown in Figure 6, for example, the biosensor 1 is attached to the skin of subject P with its longitudinal direction (Y-axis direction) aligned with the sternum of subject P, with one electrode 30B on the upper side and the other electrode 30A on the lower side. The biosensor 1 is attached to the skin of subject P by the third adhesive layer 53 in Figure 2, and with the electrodes 30 pressed against the skin of subject P, it acquires biological signals such as electrocardiogram signals from subject P using the electrodes 30. The biosensor 1 stores the acquired biological signal data in a non-volatile memory such as flash memory mounted on the component mounting section 421 of the sensor unit 40.

[0136] Thus, the biosensor 1 has a first layer member 10, a second layer member 20, and a sensor part 40. The first layer member 10 comprises a cover member 11 and a first base material 121. The cover member 11 has partition wall portions 113A and 113B at both ends in its longitudinal direction that protrude toward the second layer member 20. The first base material 121 is waterproof and breathable and is positioned so as not to overlap with the partition wall portions 113A and 113B in a plan view. Since the partition wall portions 113A and 113B cover both end faces in the longitudinal direction of the first base material 121, it is possible to prevent both end faces in the longitudinal direction of the first base material 121 from being exposed to the outside. Therefore, it is possible to reduce the amount of external water that passes through the interior of the first base material 121 from both end faces in the longitudinal direction. In addition, since the first base material 121 is breathable, water vapor from sweat generated from the skin 2 can be released to the outside through the first base material 121.

[0137] Therefore, the biosensor 1 can reduce discomfort such as itching and pain caused by moisture such as sweat or external water accumulating on the adhesive surface and irritating the skin 2, maintain a good feeling of adhesion, and also be waterproof.

[0138] Therefore, the biosensor 1 reduces discomfort to the subject during use and prevents short circuits in the flexible substrate 41 or sensor body 42 of the sensor unit 40, or corrosion of the battery 44, caused by condensation in the storage space S, thereby enabling the measurement of biological information while suppressing malfunctions in the sensor unit 40.

[0139] Furthermore, by suppressing the accumulation of moisture on the adhesive surface, the biosensor 1 prevents the adhesive surface of the biosensor 1 from peeling off the skin 2, and maintains its adherence to the skin 2. Therefore, the biosensor 1 can be stably attached to the subject's skin 2.

[0140] The biosensor 1 has partitions 113A and 113B formed to conform to the outer shape of the cover member 11 in a plan view, and the surfaces of the first base material 121 facing the partitions 113A and 113B, i.e., both longitudinal surfaces of the first base material 121, can be formed to conform to the partitions 113A and 113B in a plan view. As a result, the biosensor 1 can be easily housed inside the cover member 11.

[0141] The biosensor 1 can be formed such that both longitudinal surfaces of the first substrate 121 are in contact with the partition walls 113A and 113B. This allows the biosensor 1 to be housed with the first substrate 121 fixed inside the cover member 11, thus preventing displacement of the first substrate 121 inside the cover member 11 even if the surface of the skin 2 deforms due to body movement. Furthermore, by preventing gaps from forming between both longitudinal surfaces of the first substrate 121 and the inner surfaces of the partition walls 113A and 113B, it is possible to prevent the accumulation of moisture such as water vapor from sweat or external water between both longitudinal surfaces of the first substrate 121 and the inner surfaces of the partition walls 113A and 113B. As a result, the biosensor 1 can prevent moisture accumulated in the gaps from adhering to the sensor body 42, etc., through the interface between the cover member 11 and the first substrate 121.

[0142] The biosensor 1 has a first substrate 121 made of a porous material, and the water absorption rate on both sides in the longitudinal direction of the first substrate 121 can be made higher than the water absorption rate on both sides in the short direction of the first substrate 121. Since the partitions 113A and 113B cover both sides in the longitudinal direction of the first substrate 121, water can be prevented from entering from the parts of the first substrate 121 that have a high water absorption rate. Therefore, the biosensor 1 can more effectively enhance its waterproofness.

[0143] The biosensor 1 can have a ratio of the breaking strength of the first substrate 121 in the longitudinal direction to the breaking strength of the first substrate 121 in the short direction of 1.05 to 10.00. The higher the water absorption rate of the first substrate 121, the lower the breaking strength of the first substrate 121. By keeping the ratio of the breaking strength of the first substrate 121 in the longitudinal direction to the breaking strength of the first substrate 121 in the short direction within the above range, the biosensor 1 can make the water absorption rate of both sides of the first substrate 121 in the longitudinal direction higher than the water absorption rate of the short-side surface of the first substrate 121. Since the biosensor 1 covers both sides of the first substrate 121 in the longitudinal direction with partitions 113A and 113B, it can reduce the intrusion of water from areas of the first substrate 121 with high water absorption rates.

[0144] The biosensor 1 can have a breaking strength of 1.0 MPa to 80.0 MPa in the longitudinal direction of the first substrate 121, and a breaking strength of 0.1 MPa to 60.0 MPa in the short direction of the first substrate 121. This makes it possible to increase the water absorption rate on both sides of the first substrate 121 in the longitudinal direction compared to the water absorption rate on both sides of the first substrate 121 in the short direction. By covering both sides of the first substrate 121 in the longitudinal direction with partitions 113A and 113B, the biosensor 1 can reduce water intrusion from areas of the first substrate 121 with high water absorption. Therefore, the biosensor 1 can more effectively enhance its waterproofness.

[0145] When the first substrate 121 of the biosensor 1 is formed from a porous material, the longitudinal direction of the first substrate 121 can be defined as the MD direction of the first substrate 121, and the short direction of the first substrate 121 can be defined as the TD direction of the first substrate 121. When the first substrate 121 is formed from a porous material, the voids inside the first substrate 121 are formed in a substantially elliptical or substantially rectangular shape along the MD direction, which is the stretching direction of the first substrate 121, and the pores tend to connect with each other. The shape in the TD direction is formed in a substantially circular shape, and the pores tend to exist independently. Furthermore, the area of ​​the voids inside the first substrate 121 tends to be larger in the MD direction than in the TD direction of the first substrate 121. For this reason, the water absorption of the first substrate 121 tends to be high in the MD direction and low in the TD direction. The biosensor 1 is designed so that the longitudinal direction of the first substrate 121 is the MD direction and the short direction of the first substrate 121 is the TD direction, and by covering both longitudinal sides of the first substrate 121 with partition walls 113A and 113B, water intrusion from areas of the first substrate 121 with high water absorption can be reduced. Therefore, the biosensor 1 can more effectively enhance its waterproofness.

[0146] The biosensor 1 can be formed from a polyurethane-based thermoplastic elastomer for its second substrate 21. Polyurethane-based thermoplastic elastomers have excellent elasticity and exhibit excellent adhesion to the skin 2. Therefore, by using a polyurethane-based thermoplastic elastomer for the second substrate 21 of the biosensor 1, a good level of adhesion can be maintained.

[0147] The biosensor 1 may have electrodes 30 on the side of the second substrate 21 opposite to the first substrate 121 side, so as to be connected to the sensor body 42. This allows the biosensor 1 to bring the electrodes 30 into contact with the surface of the skin 2, and thus detect biological signals via the electrodes 30 during use.

[0148] The biosensor 1 may have a second adhesive layer 22 on the skin 2 side of the second substrate 21. Since the second adhesive layer 22 is adhesive, it can be stably attached to the skin 2, and the electrode 30 can be attached to the second layer member 20 by the second adhesive layer 22 and brought into contact with the surface of the skin 2. As a result, the biosensor 1 can maintain the electrode 30 in a stably attached state to the skin 2 and suppress displacement of the electrode 30 even when body movement occurs. Therefore, the biosensor 1 can be attached to the skin 2 more stably, and the contact impedance of the electrode 30 with the surface of the skin 2 can be reduced, thereby suppressing the generation of noise. In addition, by attaching the second layer member 20 to the skin 2 via the second adhesive layer 22, the adhesive area of ​​the attachment surface can be increased, improving the adhesion to the skin 2 and making it less likely to peel off. Thus, the biosensor 1 can improve the detection accuracy of biological signals during use and stably maintain adhesion to the skin 2.

[0149] The biosensor 1 has a third layer member 50 covering the sensor portion 40 on the side of the second base material 21 opposite to the first base material 121, and the third layer member 50 can have a third adhesive layer 53 on the side opposite to the second base material 21. As a result, the biosensor 1 can be attached to the skin 2 via the third adhesive layer 53, thereby reducing the contact impedance of the electrode 30 with the surface of the skin 2. Therefore, the biosensor 1 can further improve the detection accuracy of biological signals during use and maintain more stable adhesion to the skin 2.

[0150] Furthermore, the biosensor 1 can be configured such that the third layer member 50 is on the side of the second base material 21 opposite to the first base material 121, with the electrode 30 exposed to the skin 2. This allows the biosensor 1 to contact the surface of the skin 2 with the electrode 20 when detecting biological signals via the electrode 20, thereby ensuring reliable detection of biological signals during use.

[0151] The biosensor 1 can have an adhesive 13 provided between the partition walls 113A and 113B and the second layer member 20. By bonding the partition walls 113A and 113B to the second layer member 20 with the adhesive 13, the adhesive strength between the partition wall 113A or 113B and the second layer member 20 can be increased. In addition, it is possible to prevent external water from entering the first substrate 121 from the bottom surface of the partition walls 113A and 113B.

[0152] The biosensor 1 can use a waterproof adhesive as the adhesive 13. This makes it possible to more reliably prevent external water from entering the first substrate 121 from the bottom surface of the partition walls 113A and 113B.

[0153] The biosensor 1 may have a first adhesive layer 122 and an upper adhesive layer 123 on the surface of the first substrate 121 that is attached and on the surface that is attached to the cover member 11. This allows the first substrate 121 to have improved adhesion to the cover member 11 and the second layer member 20, thereby increasing the adhesive strength between the cover member 11 and the upper sheet 12, and between the upper sheet 12 and the second layer member 20. Furthermore, since the first adhesive layer 122 absorbs very little water, it is virtually impossible for external water to penetrate the internal storage space S of the biosensor 1 via the first adhesive layer 122 and cause water ingress. Because the biosensor 1 can suppress the penetration of external water into the interior of the biosensor 1 via the first adhesive layer 122, its waterproofness can be improved to suppress water ingress into the interior of the biosensor 1.

[0154] The biosensor 1 can form an adhesive surface to the skin 2 using the second layer member 20, the electrode 30, and the third layer member 50. This allows the biosensor 1 to be made thinner. Therefore, the biosensor 1 can be made smaller and the contact impedance with the surface of the skin 2 can be reduced.

[0155] As described above, the biosensor 1 can stably measure biological information from the skin 2 for a long period of time during use, and therefore can be effectively used as an adhesive-type biosensor that is attached to human skin 2, etc. The biosensor 1 can be suitably used, for example, in healthcare wearable devices that are attached to the skin of a living person and require high sensitivity for detecting electrocardiograms and a high level of noise suppression effect in electrocardiograms.

[0156] In this embodiment, the second layer member 20 may be formed to have a larger outer shape than the cover member 11 and the first base material 121 in a plan view. That is, the second layer member 20 may have a larger outer shape than the outer circumference of the first layer member 10 in a plan view. By widening the adhesive surface of the second layer member 20 to the skin 2, the flat surface area in contact with the skin 2 of the biosensor 1 can be increased, and the area where the thickness of the adhesive surface of the biosensor 1 is thin can be expanded. Therefore, the second layer member 20 can be flexibly deformed in response to deformation of the surface of the skin 2 due to body movement, and its adhesiveness to the skin 2 can be maintained.

[0157] Furthermore, the second layer member 20 has a larger outer shape than the outer circumference of the first layer member 10 in a plan view, thereby increasing the contact area with the skin 2 compared to the first layer member 10. As a result, the biosensor 1 can minimize contact between the first layer member 10 and the skin 2, thereby reducing the discomfort experienced by the subject due to contact with the outer circumference of the first layer member 10.

[0158] In another embodiment, instead of providing the first adhesive layer 122 and the upper adhesive layer 123 on the first substrate 121, the biosensor 1 may be made adhesive by providing an adhesive on at least one of the upper and lower surfaces of the first substrate 121.

[0159] Furthermore, in another embodiment, the sensor unit 40 may be provided with an irradiation unit that irradiates the skin 2 with infrared rays or the like, and a detection unit that detects the infrared rays or the like reflected from the skin 2 and measures biological signals, thereby measuring biological signals from the skin 2 using infrared rays or the like.

[0160] Furthermore, in another embodiment of this invention, the biosensor 1 may have a sweat-absorbing pad instead of the electrode 30 on the lower surface 101 of the first substrate 10, which is the surface on the attachment side (-Z axis direction). In this case, the sweat-absorbing pad sends the absorbed sweat to the sensor body 42 of the sensor unit 40, and the sensor body 42 measures the sweat components. This allows the biosensor 1 to be effectively used, for example, as a sensor for measuring blood glucose levels using sweat as a sample. Generally, when measuring blood glucose levels, blood is collected by inserting a needle or the like into the patient's fingertip or skin, which can be painful for the patient. The biosensor 1 can measure blood glucose levels from the sweat absorbed by the sweat-absorbing pad, using the patient's sweat as a sample, so blood glucose levels can be measured without causing pain to the patient. Therefore, it can be suitably used in the treatment of diabetes and the like.

[0161] As described above, several embodiments have been explained, but these embodiments are presented as examples only, and the present invention is not limited by these embodiments. The above embodiments can be implemented in various other forms, and various combinations, omissions, substitutions, and modifications are possible without departing from the spirit of the invention. These embodiments and their variations are included in the scope and spirit of the invention, as well as in the claims of the invention and its equivalents.

[0162] The embodiments of the present invention are, for example, as follows. <1> A biosensor that is attached to a living body, The sensor unit that acquires biometric information, A cover member having a recess in which at least a part of the sensor body is housed, and an opening that forms the recess, A first base material is provided on the opening side of the cover member, has a through hole at a position corresponding to the recess, and is waterproof and breathable, A second base material is provided on the side of the first base material opposite to the cover member and has a through hole at a position corresponding to the recess, Equipped with, The cover member has partition wall portions that protrude toward the second substrate at least at both ends in its longitudinal direction, The first substrate is a biosensor positioned in a location that does not overlap with the partition wall in a plan view. <2> The partition wall portion is formed to conform to the outer shape of the cover member in a plan view. The surface of the first substrate facing the partition wall is formed to follow the partition wall in a plan view. <1> The biosensor described above. <3> The surface of the first substrate facing the partition wall is in contact with the partition wall. <1> or <2> The biosensor described above. <4> The first substrate is a porous material, The water absorption rate of the first substrate in the longitudinal direction is greater than the water absorption rate of the first substrate in the short direction. <1> ~ <3> A biosensor listed in any one of the following. <5> The ratio of the breaking strength of the first substrate in the longitudinal direction to the breaking strength of the first substrate in the short direction is 1.05 to 10.00. <1> ~ <4> A biosensor described in any one of the following. <6> The tensile strength of the first substrate in the longitudinal direction is 1.0 MPa to 80.0 MPa. The breaking strength of the first substrate in the short direction is 0.1 MPa to 60.0 MPa. <1> ~ <5> A biosensor listed in any one of the following. <7> The longitudinal direction is the MD direction of the first substrate, The aforementioned short direction is the TD direction of the first substrate. <4> ~ <6> A biosensor described in any one of the following. <8> The second substrate is a polyurethane thermoplastic elastomer. <1> ~ <7> A biosensor described in any one of the following. <9> The second substrate is formed such that, in a plan view, its outer shape is larger than the outer shapes of the cover member and the first substrate. <1> ~ <8> A biosensor described in any one of the following. <10> The second substrate has an electrode connected to the sensor body on the side opposite to the first substrate. <1> ~ <9> A biosensor described in any one of the following. <11> The second substrate has an adhesive layer on the side opposite to the first substrate to which the electrodes are attached. <10> The biosensor described above. <12> The second substrate has a sweat-absorbing pad connected to the sensor body on the side opposite to the first substrate. <1> ~ <11> A biosensor described in any one of the following. <13> The second substrate is provided with a third layer member attached to the side opposite to the first substrate so as to cover the sensor body, The third layer member has an adhesive layer on the side opposite to the second substrate. <1> ~ <12> A biosensor described in any one of the following. <14> The second substrate is provided with a third layer member attached to the side opposite to the first substrate, exposing the electrodes and covering the sensor body. The third layer member has an adhesive layer on the side opposite to the second substrate. <10> or <11> The biosensor described above. <15> The first substrate has an adhesive on at least one of the surfaces on the cover member side and the second substrate side. <1> ~ <14> A biosensor described in any one of the following. <16> The first substrate has an adhesive layer on at least one of the surfaces on the cover member side and the second substrate side. <1> ~ <14> A biosensor described in any one of the following. [Explanation of Symbols]

[0163] 1. Biosensor 2 skin 10. First layer member 11 Cover member 12 Upper sheet 12a, 20a, 121a, 122a through hole 20 Second layer member 21 Second base material 22 Second adhesive layer 30, 30A, 30B electrode 40 Sensor section 41 Flexible circuit board 42 Sensor body 43A Connection 43A, 43B connection section 44 batteries 50 Third layer member 51 Third base material 52 Lower adhesive layer 53 Third adhesive layer 111 Protrusion 111a depression 113A, 113B Bulkhead 121 1st base material 122 1st adhesive layer 123 Upper adhesive layer 421 Component mounting section 422 Battery mounting section 431A, 431B wiring 432A, 432B terminal section

Claims

1. A biosensor that is attached to a living body, The sensor unit that acquires biometric information, A cover member having a recess in which at least a part of the sensor body is housed, and an opening that forms the recess, A first base material is provided on the opening side of the cover member, has a through hole at a position corresponding to the recess, and is waterproof and breathable, A second base material is provided on the side of the first base material opposite to the cover member and has a through hole at a position corresponding to the recess, Equipped with, The cover member has partition wall portions that protrude toward the second substrate at least at both ends in its longitudinal direction, The first substrate is a biosensor positioned in a location that does not overlap with the partition wall in a plan view.

2. The partition wall portion is formed to conform to the outer shape of the cover member in a plan view. The biosensor according to claim 1, wherein the surface of the first substrate facing the partition wall is formed to follow the partition wall in a plan view.

3. The biosensor according to claim 1, wherein the surface of the first substrate facing the partition wall is in contact with the partition wall.

4. The first substrate is a porous material, The biosensor according to claim 1, wherein the water absorption rate in the longitudinal direction of the first substrate is greater than the water absorption rate in the short direction of the first substrate.

5. The biosensor according to claim 1, wherein the ratio of the breaking strength of the first substrate in the longitudinal direction to the breaking strength of the first substrate in the short direction is 1.05 to 10.

00.

6. The tensile strength of the first substrate in the longitudinal direction is 1.0 MPa to 80.0 MPa. The biosensor according to claim 1, wherein the breaking strength of the first substrate in the short direction is 0.1 MPa to 60.0 MPa.

7. The longitudinal direction is the MD direction of the first substrate, The biosensor according to claim 4, wherein the short direction is the TD direction of the first substrate.

8. The biosensor according to claim 1, wherein the second substrate is a polyurethane thermoplastic elastomer.

9. The biosensor according to claim 1, wherein the second substrate is formed to have an outer shape larger than the outer shapes of the cover member and the first substrate in a plan view.

10. The biosensor according to claim 1, wherein the second substrate has an electrode connected to the sensor body on the side of the second substrate opposite to the first substrate side.

11. The biosensor according to claim 10, having an adhesive layer on the side of the second substrate opposite to the first substrate side to which the electrodes are attached.

12. The biosensor according to claim 1, having a sweat-absorbing pad connected to the sensor body on the side of the second substrate opposite to the first substrate side.

13. The second substrate is provided with a third layer member attached to the side opposite to the first substrate so as to cover the sensor body, The biosensor according to claim 1, wherein the third layer member has an adhesive layer on the side opposite to the second substrate.

14. The second substrate is provided with a third layer member attached to the side opposite to the first substrate, exposing the electrodes and covering the sensor body. The biosensor according to claim 10, wherein the third layer member has an adhesive layer on the side opposite to the second substrate.

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