Biological sensor

Abstract

To provide a biological sensor capable of improving adhesion reliability for a living body surface and improving contact impedance.SOLUTION: A biological sensor to be stuck to a living body includes: a sensor body for acquiring biological information; an electrode connected to the sensor body; and a first layer member having a storge space for storing the sensor body and an opening of the storage space, and having a cover member having a longitudinal direction. The cover member has: a first sheet part formed in a region including the electrode outside the storage space in a plane view of the biological sensor; and second sheet parts formed at least on both end sides in the longitudinal direction of an outer periphery of the first sheet part, and thinner in thickness than the first sheet part. The bending rigidity of the first sheet part is 0.01 N mm2 to 2.0 N mm2, and the bending rigidity of the second sheet part is 1.0 N mm2 to 20 N mm2.SELECTED DRAWING: Figure 1

Description

[Technical Field]

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

[0002] Wearable biosensors that acquire bioinformation such as electrocardiogram waveforms, pulse waves, electroencephalograms, and electromyography are used in medical institutions such as hospitals and clinics, nursing homes, homes, etc. The biosensor is equipped with bioelectrodes that acquire the subject's bioinformation by coming into contact with the living body, and when measuring the bioinformation, the biosensor is attached to the subject's skin and electrical signals related to the bioinformation are acquired by the bioelectrodes, thereby measuring the bioinformation.

[0003] As such a biosensor, for example, a biosensor has been disclosed that has a sensor body, electrodes, a first layer member formed by laminating a cover on an upper sheet so that the sensor body can be stored therein, and a second layer member attached to the surface of the first layer member facing the living body, in which the sensor body is installed and the electrodes are exposed (see, for example, Patent Document 1).

[0004] In this biosensor, a first adhesive layer is provided on the surface of the first layer member facing the living body, and a second adhesive layer is provided on the surface of the second layer member facing the living body.The first adhesive layer and the second adhesive layer are attached to the skin, and bioinformation is acquired using an electrode attached to the first adhesive layer while exposed from the second layer member. [Prior art documents] [Patent documents]

[0005] [Patent Document 1] Patent No. 6947955 Summary of the Invention [Problem to be solved by the invention]

[0006] Here, biosensors such as the biosensor described in Patent Document 1 are often used by being attached to the biological surface, such as the skin, of a subject for a long period of time. Therefore, in order to stably acquire electrical signals related to biological information for a long period of time while reducing the burden on the subject, it is important to make the biosensor less likely to come off the body and to increase the reliability of adhesion to the biological surface by suppressing deterioration in the wearing comfort. Furthermore, in order to acquire biological information with high sensitivity, it is desirable to bring the bioelectrode into close contact with the body and reduce contact impedance.

[0007] An object of one aspect of the present invention is to provide a biosensor that can improve the adhesion reliability to the surface of a living body and also improve the contact impedance. [Means for solving the problem]

[0008] One aspect of the biosensor according to the present invention is A biosensor to be attached to a living body, a sensor body for acquiring biological information; an electrode connected to the sensor body; a first layer member having a storage space for storing the sensor body and an opening of the storage space, and a cover member having a longitudinal direction; the cover member has a first sheet portion formed in a region including the electrodes outside the storage space in a plan view of the biosensor, and a second sheet portion formed on at least both longitudinal end sides of the periphery of the first sheet portion and having a thickness thinner than the first sheet portion; The bending rigidity of the first sheet portion is 0.01 N·mm 2 ~2.0N·mm 2 and The bending rigidity of the second sheet portion is 1.0 N·mm 2 ~20N·mm 2 is. [Effects of the Invention]

[0009] One aspect of the biosensor according to the present invention can improve the reliability of adhesion to the surface of a living body and also improve the contact impedance. [Brief explanation of the drawings]

[0010] [Figure 1] 1 is a perspective view showing an overall configuration of a biosensor according to an embodiment of the present invention; [Figure 2] FIG. 2 is a plan view showing an example of each component of the biosensor. [Figure 3] 2 is a longitudinal cross-sectional view of the biosensor, and is a cross-sectional view taken along line II in FIG. 1. FIG. [Figure 4] 2 is an explanatory diagram showing a state in which the biosensor of FIG. 1 is attached to the chest of a living body. [Figure 5] FIG. 1 is an explanatory diagram showing an example of a noise-free electrocardiogram waveform. [Figure 6] FIG. 10 is a plan view showing an example of another configuration of the cover member. [Figure 7] FIG. 10 is a plan view showing an example of another configuration of the cover member. [Figure 8] FIG. 10 is a plan view showing an example of another configuration of the cover member. [Figure 9] FIG. 2 is a diagram showing dimensions of the cover member 1-1 in a plan view. [Figure 10] FIG. 2 is a diagram showing dimensions of cover members 2-1 and 2-2 in a plan view. [Figure 11] 3 is a diagram showing dimensions of the cover member 3 in a plan view. FIG. [Figure 12] 3 is a diagram showing dimensions of the cover member 4 in a plan view. FIG. [Figure 13] FIG. 2 is a diagram showing dimensions of cover members 5-1 and 5-2 in a plan view. DETAILED DESCRIPTION OF THE INVENTION

[0011] Hereinafter, embodiments of the present invention will be described in detail. To facilitate understanding of the description, the same components in each drawing will be denoted by the same reference numerals, and duplicate descriptions will be omitted. The scale of each component in the drawings may differ from the actual scale. In this specification, unless otherwise specified, "to" indicating a range of values means that the values before and after it are included as the lower and upper limits.

[0012] <Biosensor> A biosensor according to this embodiment will be described. Note that a biosensor refers to a human body (person) and animals such as cows, horses, pigs, chickens, dogs, and cats. The biosensor according to this embodiment can be suitably used for biosensors, particularly for human bodies. In this embodiment, a case where the biosensor is a human will be described as an example.

[0013] The biosensor according to this embodiment is an adhesive biosensor that is attached to a part of a living body (for example, the skin, scalp, or forehead) to measure bioinformation. In this embodiment, a case will be described in which the biosensor is attached to human skin to measure an electrical signal (biological signal) related to the bioinformation of the human.

[0014] FIG. 1 is a perspective view showing the overall configuration of a biosensor according to this embodiment. The left side of FIG. 1 shows the appearance of the biosensor according to this embodiment, and the right side of FIG. 1 shows the biosensor according to this embodiment in an exploded state, with each component of the biosensor. FIG. 2 is a plan view showing an example of each component of the biosensor. FIG. 3 is a longitudinal cross-sectional view of the biosensor, taken along line II in FIG. 1.

[0015] As shown in Figures 1 and 2, the biosensor 1 is a plate-like (sheet-like) member formed into a substantially elliptical shape in a plan view. As shown in Figures 2 and 3, the biosensor 1 has a first layer member 10, electrodes 20, a sensor unit 30, and a second layer member 40, and is formed by laminating the first layer member 10, the electrodes 20, and the second layer member 40 in this 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 electrodes 20, and the second layer member 40 form an attachment surface to be attached to skin 2, which is an example of a living body. The attachment surface of the biosensor 1 is attached to the skin 2, and the potential difference (polarization voltage) between the skin 2 and the electrodes 20 is measured to measure an electrical signal (biological signal) related to the biological information of the subject.

[0016] 1 to 3, a three-dimensional Cartesian coordinate system with three axes (X-axis, Y-axis, and Z-axis) is used, with the shorter side of the biosensor being the X-axis direction, the longer side being the Y-axis direction, and the height direction (thickness direction) being the Z-axis direction. The opposite direction (outside) of the side of the biosensor 1 that is attached to the living body (subject) (attachment side) is the +Z-axis direction, and the attachment side is 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 top, and the -Z-axis direction may be referred to as the lower side or bottom, but this does not represent a universal vertical relationship.

[0017] The biological signal is an electrical signal that represents, for example, an electrocardiogram waveform, an electroencephalogram, a pulse, or the like.

[0018] When using the biosensor 1, the inventors of the present application focused on the effect that the ease of bending deformation of the cover member 11 provided on the surface side of the first layer member 10 has on the adhesive strength of the electrode 20 to the skin 2 and on the adherence of the electrode 20 to the surface of the skin 2. The inventors then considered increasing the thickness of the region of the cover member 11 that includes the electrode 20 in a plan view of the biosensor 1 and reducing the thickness of at least both longitudinal ends of the outer periphery of the region that includes the electrode 20. The inventors found that configuring the cover member 11 in this way increases the adhesion of the electrode 20 to the surface of the skin 2 and makes the outer periphery of the cover member 11 more easily bent than the inside, thereby increasing the contact impedance of the electrode 20 and improving the adherence of the biosensor 1 to the electrode 20 when the biosensor 1 is in use.

[0019] [First layer member] 1 and 2, the first layer member 10 includes a cover member 11 and an upper sheet 12 laminated in this order. The cover member 11 and the upper sheet 12 have substantially the same outer shape in a plan view.

[0020] The first layer member 10 has a rectangular shape with a longitudinal direction (Y-axis direction) and a lateral direction (X-axis direction) in a plan view, and may have semicircular roundness on both ends in the longitudinal direction.

[0021] The first layer member 10 may have two sets of cutouts 13 formed corresponding to both longitudinal surfaces. The two sets of cutouts 13 may be arranged symmetrically with respect to an axis passing through the center of the first layer member 10 in the short direction. The number of cutouts 13 is not particularly limited, and may be any number appropriate depending on the size, shape, etc. of the first layer member 10.

[0022] (Cover member) 3, the cover member 11 is located at the outermost position (+Z-axis direction) of the biosensor 1 and is adhered to the upper surface of the upper sheet 12. In a plan view of the cover member 11, the cover member 11 has a protruding portion 111 that protrudes in the height direction (+Z-axis direction) of FIG. 1 from the center portion in the longitudinal direction (Y-axis direction), a first sheet portion 112 that is provided on the outer periphery of the protruding portion 111 in the lateral direction (X-axis direction) and the longitudinal direction (Y-axis direction), and a second sheet portion 113 that is provided on the outer periphery of the first sheet portion 112. Note that in a plan view, the distance in the longitudinal direction and the distance in the lateral direction between the periphery of the first sheet portion 112 and the periphery of the second sheet portion 113 may be approximately the same or different.

[0023] The cover member 11 has a notch 11a that constitutes a part of the notch 13.

[0024] The cover member 11 has a depression 111a formed in a concave shape facing the living body side on the inner side (attachment side) of the protrusion 111 and the first sheet portion 112. On the inner side (attachment side) of the protrusion 111, a storage space S for storing the sensor unit 30 is formed by the depression 111a on the inner surface of the protrusion 111, the electrode 20, and the second layer member 40.

[0025] The upper and lower surfaces of the protrusion 111, the first sheet portion 112 and the second sheet portion 113 may each be formed flat.

[0026] The protrusion 111, the first sheet portion 112, and the second sheet portion 113 may be formed in the center of the longitudinal direction (Y-axis direction) so as to protrude in an approximately dome shape toward the height direction (+Z-axis direction) of Figure 1.

[0027] The first sheet portion 112 may be formed with an inclination so that its thickness decreases from the protruding portion 111 toward the second sheet portion 113. The shape and inclination of the first sheet portion 112 in the longitudinal direction and the lateral direction may be the same or different.

[0028] 4, the first sheet portion 112 may be formed above a position overlapping with at least a portion of the electrode 20 in a plan view of the biosensor 1. In order to maintain a state in which the electrode 20 is stably attached to the skin 2, the first sheet portion 112 is preferably formed to include the entire electrode 20 in a plan view of the biosensor 1.

[0029] 1, the second sheet portion 113 is provided on the outer periphery of the first sheet portion 112, and is provided on both end sides in the long side direction and short side direction of the cover member 11. The second sheet portion 113 may be formed integrally with the first sheet portion 112. The second sheet portion 113 may be formed with an inclination such that the thickness of the second sheet portion 113 becomes thinner from the first sheet portion 112 toward the long side direction or short side direction of the cover member 11.

[0030] The second sheet portion 113 may be composed of a second sheet portion 113A formed on the longitudinal direction (-Y axis direction) side, a second sheet portion 113B formed on the longitudinal direction (+Y axis direction) side, and a second sheet portion 113C formed on the X axis direction (short side direction) side of the protruding portion 111. Note that the second sheet portion 113 may be composed of only the second sheet portion 113A and the second sheet portion 113B.

[0031] The cover member 11 may be formed using a flexible material such as a thermoplastic resin such as an acrylic resin, a polyurethane resin, a polystyrene resin, a polyolefin resin, a silicone resin, a vinyl chloride resin, or a polyester resin, a thermoplastic elastomer, or a cross-linked rubber.

[0032] Examples of the thermoplastic elastomer 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 hydrogenated products thereof, styrene-isoprene block copolymers or hydrogenated products thereof, etc. These may be used alone or in combination of two or more.

[0033] Examples of cross-linked rubber 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. The cover member 11 may be formed by laminating the flexible material on the surface of a base resin such as polyethylene terephthalate (PET) as a support. By forming the cover member 11 using the flexible material, the sensor unit 30 placed in the storage space S of the cover member 11 is protected, and impacts applied to the biosensor 1 from the top surface are absorbed, thereby softening the impact on the sensor unit 30.

[0034] The thickness of the upper surface and side walls of the protruding portion 111 may be thicker than the thicknesses of the first sheet portion 112 and the second sheet portion 113. This allows the flexibility of the protruding portion 111 to be lower than the flexibility of the first sheet portion 112 and the second sheet portion 113, and makes it possible to protect the sensor portion 30 from external forces applied to the biosensor 1.

[0035] The thickness of first sheet portion 112 is greater than the thickness of second sheet portion 113. As a result, the bending rigidity of first sheet portion 112 is greater than the bending rigidity of second sheet portion 113, and the weight of first sheet portion 112 is greater than the weight of second sheet portion 113, so that the stress applied to skin 2 side is increased and its fluctuation is suppressed. Therefore, electrode 20 is pressed against skin 2 side stably.

[0036] The thickness of the upper surface and side wall of the protrusion 111 and the first sheet portion 112 can be designed appropriately and may be, for example, 1.5 mm to 3 mm. The thickness of the second sheet portion 113 can also be designed appropriately and may be, for example, 0.5 mm to 1 mm.

[0037] The thickness of the protrusion 111, the first sheet portion 112, and the second sheet portion 113 refers to the length in the direction perpendicular to the surface of the protrusion 111, the first sheet portion 112, and the second sheet portion 113. The thickness of the protrusion 111, the first sheet portion 112, and the second sheet portion 113 is, for example, the thickness measured at an arbitrary location on the cross section of the protrusion 111, the first sheet portion 112, and the second sheet portion 113, and when measurements are taken at multiple locations at an arbitrary location, the thickness may be the average value of the thicknesses measured at these measurement locations.

[0038] The second sheet portion 113, which is thinner, is more flexible than the protruding portion 111 and the first sheet portion 112, and therefore, when the biosensor 1 is attached to the skin 2, it is more likely to deform in accordance with deformation of the surface of the skin 2 due to bodily movements such as stretching, bending, and twisting. This makes it possible to alleviate the stress applied to the second sheet portion 113 when the surface of the skin 2 is deformed, and makes it difficult for the biosensor 1 to peel off from the skin 2.

[0039] The thickness of second sheet portion 113 is preferably 60% or less, more preferably 50% or less, and even more preferably 35% or less of the thickness of first sheet portion 112. If the thickness of second sheet portion 113 is 60% or less of the thickness of first sheet portion 112, second sheet portion 113 can ensure flexibility and can be stably adhered to skin 2.

[0040] The outer periphery of second sheet portion 113 may have a shape in which the thickness gradually decreases toward the edge. This can further increase the flexibility of the outer periphery of second sheet portion 113, and improve the wearing comfort when biosensor 1 is attached to skin 2 compared to when the thickness of the outer periphery of second sheet portion 113 is not thin. Note that, as will be described later, upper sheet 12 can reduce the stress applied to second sheet portion 113 when the surface of skin 2 is deformed.

[0041] The moisture permeability of the cover member 11 can be appropriately designed, for example, 300 g / (m 2 The moisture permeability of the cover member 11 may be 300 g / (m 2 If the time is less than 10 days, when water vapor due to sweat or the like generated from the skin 2 to which the biosensor 1 is attached reaches the cover member 11, the water vapor can be released to the outside of the biosensor 1 through the cover member 11.

[0042] The hardness of the cover member 11 can be designed to any appropriate value, and may be, for example, 10 to 40. If the hardness of the cover member 11 is within the above-mentioned preferred range, when the skin 2 stretches due to body movement, the upper sheet 12, the electrodes 20, and the second layer member 40 can easily deform in accordance with the movement of the skin 2 without being affected by the cover member 11. The hardness (hardness) may be Shore A hardness or Shore D hardness. The hardness of the cover member 11 may be selected appropriately depending on the material from which the cover member 11 is formed. For example, when the cover member is formed using a thermoplastic resin, Shore D hardness may be used, and when the cover member is formed using a thermoplastic elastomer or cross-linked rubber, Shore A hardness may be used.

[0043] In this specification, Shore A hardness and Shore D hardness refer to values measured in accordance with ISO 7619-1 (JIS K 6253-3:2012). Shore A hardness is a Type A durometer hardness measured with a rubber hardness tester (Type A durometer) using a Type A (cylindrical) indenter, and Shore D hardness is a Type D durometer hardness measured with a Type D durometer (Type D durometer) using a Type D (conical) indenter. As described in JIS K 6253-3:2012, "Vulcanized rubber and thermoplastic rubber - Determination of hardness - Part 3: Durometer hardness," the Type A durometer hardness and Type D durometer hardness measured on a sheet sample having a predetermined size prepared using the cover member 11 may be used as the Shore A hardness and Shore D hardness of the cover member 11.

[0044] The bending rigidity of the first sheet portion 112 is 1.0 N·mm 2 ~20N·mm 2 and 1.0 N mm 2 ~20N·mm 2 Preferably, it is 1.0 N·mm 2 ~20N·mm 2 It is more preferable that the bending rigidity of the first sheet portion 112 is 1.0 N·mm 2 If the bending rigidity of the first sheet portion 112 is less than 20 N·mm, the first sheet portion 112 will be too hard and will have poor flexibility, which is undesirable. 2 If the thickness exceeds this value, the first sheet portion 112 may become too soft, which may reduce adhesiveness and increase the contact impedance of the electrode.

[0045] The bending rigidity of the second sheet portion 113 is 0.01 N·mm 2 ~2.0N·mm 2 and 0.1 N mm 2 ~2.0N·mm 2 Preferably, it is 0.01 N mm 2 ~2.0N·mm 2 It is more preferable that the bending rigidity of the second sheet portion 113 is 0.01 N·mm 2If the bending rigidity of the second sheet portion 113 is less than 2.0 N·mm, the deformation amount of the second sheet portion 113 is insufficient and the flexibility is poor, which tends to reduce the adhesion to the skin 2, which is undesirable. 2 If the thickness exceeds this range, the second sheet portion 113 may become too soft, which may reduce the adhesiveness to the skin 2.

[0046] The tensile modulus of the cover member 11 may be, for example, 1.5 MPa or less at room temperature (23°C ± 2°C). If the tensile modulus of the cover member 11 at room temperature (23°C ± 2°C) is 1.5 MPa or less, the cover member 11 can relieve stress that occurs with deformation of the biological surface, and therefore can exhibit excellent stretchability relative to the biological surface.

[0047] (Upper sheet) 3, the upper sheet 12 is adhered to the lower surface of the cover member 11. The upper sheet 12 has a through hole 12a at a position facing the protrusion 111 of the cover member 11. The through hole 12a allows the sensor main body 32 of the sensor unit 30 to 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 without being obstructed by the upper sheet 12.

[0048] The upper sheet 12 has a first substrate 121, a first adhesive layer 122 to which the electrode 20 is attached on one side of the first substrate 121 facing the electrode 20, and an upper adhesive layer 123 provided on the side opposite to the one side of the first substrate 121 facing the electrode 20.

[0049] The upper sheet 12 has a cutout 12b that forms part of the cutout 13.

[0050] ((1st base material)) The first substrate 121 is formed in a sheet shape. The first substrate 121 may be flexible, waterproof, and breathable. The first substrate 121 having flexibility, waterproof, and breathable properties makes it easy for the first substrate 121 to stretch when in contact with the skin 2, allowing it to maintain contact with the skin 2 and preventing liquid from penetrating into the gap between the first substrate 121 and the upper adhesive layer 123. Furthermore, water vapor due to sweat or the like generated from the skin 2 can be released to the outside of the biosensor 1 through the first substrate 121. This makes it easier for the upper sheet 12 to maintain adhesion durability.

[0051] As long as the first substrate 121 is flexible, waterproof, and moisture-permeable, it may be a non-porous body without a porous structure, or a porous body with a porous structure. If the first substrate 121 is a non-porous body, it is easier to maintain the thin film and strength of the first substrate 121, which is preferable. If the first substrate 121 is a porous body, it is easier to release water vapor due to sweat or the like generated from the skin 2 to which the biosensor 1 is attached to the first substrate 121 to the outside of the biosensor 1 through the first substrate 121, which is preferable.

[0052] As the non-porous body, a molded body formed into a sheet shape can be used.

[0053] The porous body may have a cell structure such as open cells, closed cells, or semi-closed cells. That is, the porous body may be a porous body manufactured by foam molding to form open cells (a porous body having an open cell structure), a porous body manufactured by foam molding to form closed cells (a porous body having a closed cell structure), or a porous body manufactured by foam molding to form semi-closed cells (a porous body having a semi-closed cell structure). Among these, a porous body having a closed cell structure is preferred in terms of achieving higher waterproofing while maintaining thinness and strength. Examples of porous bodies that can be used include foam sheets and nonwoven fabric sheets.

[0054] The material for forming the first substrate 121 may be, for example, 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 flexible material such as a thermoplastic elastomer.

[0055] 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 hydrogenated products thereof, and styrene-isoprene block copolymers or hydrogenated products thereof. These may be used alone or in combination of two or more. Among these, polyurethane-based thermoplastic elastomers are preferred.

[0056] When the first base material 121 is non-porous, specifically, a polyurethane sheet such as Esmer URS manufactured by Nippon Matai may be used.

[0057] When first substrate 121 is a porous body, specifically, a foam sheet such as FOLEC manufactured by Inoac Corporation, or a nonwoven fabric sheet such as EW, a medicated patch fabric manufactured by Nippon Vilene, may be used.

[0058] The moisture permeability of the first base material 121 may be higher than that of the cover member 11, but the moisture permeability of the first base material 121 is 100 g / (m 2 ·day)~5000g / (m 2 ·day). The moisture permeability of the first substrate 121 is preferably 100 g / (m 2 ·day)~5000g / (m 2By setting the temperature (day), the first base material 121 can allow water vapor that has entered from one side to pass through the inside of the first base material 121 and be released stably from the other side.

[0059] The thickness of first substrate 121 can be set appropriately depending on the type of first substrate 121, etc., but is preferably thicker than the thickness of the outer periphery of cover member 11. If the thickness of first substrate 121 is thicker than the thickness of the outer periphery of cover member 11, it is possible to reduce irritation caused by the outer periphery of cover member 11 coming into contact with skin 2. The thickness of first substrate 121 is preferably, for example, 10 μm to 1.5 mm, and more preferably 0.7 mm to 1.0 mm.

[0060] When first base material 121 is formed of a porous material such as a foam sheet or a nonwoven fabric sheet, the thickness of first base material 121 is preferably, for example, 0.5 mm to 1.5 mm, and more preferably about 1 mm.

[0061] When the first base material 121 is formed of a non-porous material such as a polyurethane sheet, the thickness of the first base material 121 is preferably, for example, 10 μm to 300 μm, and more preferably about 30 μm.

[0062] The first base material 121 has a through hole 121a at a position facing the protruding portion 111 of the cover member 11. By providing the first adhesive layer 122 and the upper adhesive layer 123 on the surface of the first base material 121 other than the through hole 121a, the 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.

[0063] When the thickness of the first base material 121 is 0.2 mm, the bending rigidity is 0.005 N mm 2 ~0.035N·mm 2 Preferably, it is 0.010 N mm 2 ~0.030N·mm 2 More preferably, it is 0.015 N mm 2 ~0.025N·mm 2It is more preferable that the bending rigidity of the first base material 121 is 0.005 N·mm 2 ~0.035N·mm 2 In this case, first base material 121 can have an appropriate degree of softness, and therefore can easily accommodate deformation of the surface of skin 2 due to body movement.

[0064] ((1st adhesive layer)) 3, first adhesive layer 122 is provided in a state of being attached to one surface of first base material 121 facing electrode 20. First adhesive layer 122 is located on the surface of first base material 121 facing the living body (-Z axis direction), and has the functions of adhering skin 2 and first base material 121 together, adhering first base material 121 and second base material 41 together, and adhering first base material 121 and electrode 20 together.

[0065] The first adhesive layer 122 may be moisture permeable. As described below, this allows water vapor, such as sweat generated from the skin 2 to which the biosensor 1 is attached, to escape through the first adhesive layer 122 to the first base material 121 and be released from the first base material 121 to the outside of the biosensor 1. If the first base material 121 has a cellular structure as described above, water vapor can be released to the outside of the biosensor 1 through the first adhesive layer 122. This prevents sweat or water vapor from accumulating at the interface between the skin 2 to which the biosensor 1 is attached and the first layer member 10. As a result, moisture accumulated at the interface between the skin 2 and the first adhesive layer 122 weakens the adhesive strength of the first adhesive layer 122, preventing the biosensor 1 from peeling off from the skin 2.

[0066] The moisture permeability of the first adhesive layer 122 is, for example, 1 g / (m 2 ·day) or more. The moisture permeability of the first adhesive layer 122 is preferably 10000 g / (m 2 ·day) or less. The moisture permeability of the first adhesive layer 122 may be 1 g / (m 2 ·days) or more, when the first adhesive layer 122 is attached to the skin 2, sweat and the like transmitted through the first adhesive layer 122 can be transmitted to the outside, thereby reducing the load on the skin 2.

[0067] A pressure-sensitive adhesive material may be used as the material for forming the first adhesive layer 122. Examples of pressure-sensitive adhesive materials that can be used include acrylic adhesives and silicone adhesives, and it is preferable to use an acrylic adhesive. Examples of acrylic adhesives include acrylic polymers described in JP 2002-65841 A.

[0068] The first adhesive layer 122 may be a double-sided adhesive tape made of the above-mentioned material. When the cover member 11 is laminated on the first adhesive layer 122 to form the biosensor 1, the waterproofness of the biosensor 1 can be improved and the bonding strength with the cover member 11 can be improved.

[0069] The first adhesive layer 122 may have a wavy pattern (web pattern) formed on its surface, in which adhesive-containing areas and non-adhesive areas without adhesive are alternately formed. The first adhesive layer 122 may be, for example, a double-sided adhesive tape with a web pattern formed on its surface. By having a web pattern on its surface, the first adhesive layer 122 can adhere to convex portions and their surroundings on the surface, while preventing the adhesive from adhering to concave portions and their surroundings. Therefore, the surface of the first adhesive layer 122 has both portions with and without adhesive, allowing the adhesive to be scattered across the surface of the first adhesive layer 122. The thinner the adhesive, the higher the moisture permeability of the first adhesive layer 122. Therefore, by forming a web pattern on its surface and having thin portions of adhesive on the first adhesive layer 122, moisture permeability can be improved while maintaining adhesive strength compared to a case without a web pattern.

[0070] The width of the adhesive forming portion and the non-adhesive portion can be designed as appropriate, and the width of the adhesive forming portion is preferably 500 μm to 1000 μm, and the width of the non-adhesive portion is preferably 1500 μm to 5000 μm. If the widths of the adhesive forming portion and the non-adhesive portion are each within the above preferred ranges, first adhesive layer 122 can exhibit excellent moisture permeability while maintaining adhesive strength.

[0071] The thickness of the first adhesive layer 122 can be set arbitrarily and may 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.

[0072] The adhesive strength of first adhesive layer 122 can be set arbitrarily, and for example, with respect to a Bakelite plate, is preferably 3.0 N / 10 mm to 20 N / 10 mm, more preferably 4.0 N / 10 mm to 15 N / 10 mm, and even more preferably 5.0 N / 10 mm to 10 N / 10 mm. If the adhesive strength of first adhesive layer 122 is 3.0 N / 10 mm to 20 N / 10 mm, first adhesive layer 122 forms part of the adhesive surface of biosensor 1 that is attached to the surface of skin 2, thereby improving the adhesiveness of biosensor 1 to the living body.

[0073] ((Top adhesive layer)) 3, the upper adhesive layer 123 is provided in a state of being attached to the surface opposite to one surface of the first base material 121 that faces the electrode 20. The upper adhesive layer 123 is attached to the upper surface of the first base material 121 at a position corresponding to the flat surface on the attachment side of the cover member 11 (in the −Z axis direction), and has the function of bonding the first base material 121 and the cover member 11 together.

[0074] A biocompatible material is used as the material for forming the upper adhesive layer 123. Examples of biocompatible materials that can be used include acrylic adhesives, silicone adhesives, and silicone tapes, and it is preferable to use silicone adhesives.

[0075] The thickness of the upper adhesive layer 123 can be set appropriately, and may be, for example, 10 μm to 300 μm.

[0076] [electrode] 3, the electrode 20 is attached to the underside (-Z-axis direction) of the first adhesive layer 122, with a portion of the electrode 20 on the sensor main body 32 side connected to the wiring 331A and 331B, and is sandwiched between 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 comes into contact with a living body. When the biosensor 1 is attached to the skin 2, the electrode 20 comes into contact with the skin 2, thereby detecting a biological signal. The electrode 20 may be embedded in the second base material 41 in an exposed state so as to be able to come into contact with the skin 2.

[0077] The electrode 20 may be provided so as to be located below the area including the first sheet portion 112 when the biosensor 1 is seen in a plan view.

[0078] The electrode 20 is composed of a pair of electrodes 20A and 20B. As shown in FIG. 3, the electrode 20A is disposed on the left side of the drawing, and the electrode 20B is disposed on the right side of the drawing. One end (inner side) of the electrode 20A in the longitudinal direction (Y-axis direction) is in contact with the terminal portion 332A, and one end (inner side) of the electrode 20B in the longitudinal direction (Y-axis direction) is in contact with the terminal portion 332B. The pair of electrodes 20A and 20B have substantially the same shape.

[0079] The one end side of electrode 20A that contacts terminal portion 332A of sensor unit 30 and the one end side of electrode 20B that contacts terminal portion 332B of sensor unit 30 are referred to as opposed portions 20a. The portion of electrode 20A that does not contact terminal portion 332A and the portion of electrode 20B that does not contact terminal portion 332B (the other end side (outside) in the longitudinal direction (Y-axis direction)) are referred to as exposed portions 20b.

[0080] The electrode 20 may have any shape, such as a sheet shape.

[0081] The shape of electrode 20 in a plan view is not particularly limited, and may be designed to have any shape as appropriate depending on the application, etc. As shown in Fig. 2, electrode 20 may have, in a plan view, facing portion 20a at one end formed in an arc shape, and exposed portion 20b at the other end formed in a rectangular shape.

[0082] 2 and 3, electrode 20 may have through-hole 20c, which is an oval shape elongated in the width direction (X-axis direction) and provided at one end (inner side) in the longitudinal direction (Y-axis direction), and through-hole 20d, which is a circle, provided at the other end (outer side) in the longitudinal direction (Y-axis direction). This allows first adhesive layer 122 to be exposed to the attachment side from through-holes 20c and 20d when electrode 20 is attached to first adhesive layer 122, thereby improving adhesion between electrode 20 and skin 2. The number of through-holes 20c and 20d is not particularly limited and may be set appropriately depending on the size of facing portion 20a of electrode 20, etc.

[0083] 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, or the like. Among these, from the viewpoint of biological safety, such as preventing allergic reactions when the electrode 20 is applied to a living body, it is preferable to form the electrode 20 using a cured product of the conductive composition. The electrode 20 may also be an electrode sheet formed by forming a sheet of a cured product of the conductive composition.

[0084] 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 derivatives thereof, as well as composites thereof. These may be used alone or in combination. Among these, composites in which polythiophene is doped with polyaniline as a dopant are preferred. Among composites of polythiophene and polyaniline, PEDOT / PSS, in which poly(3,4-ethylenedioxythiophene) (also known as PEDOT) is doped with polystyrene sulfonic acid (poly4-styrenesulfonate; PSS) as the polyaniline, is more preferred because of its lower contact impedance with a living body and high conductivity.

[0085] The binder resin may be a water-soluble polymer or a water-insoluble polymer, etc. As the water-soluble polymer, a hydroxyl group-containing polymer such as polyvinyl alcohol (PVA) or modified PVA may be used.

[0086] The conductive composition may contain various general additives such as a crosslinking agent and a plasticizer in any appropriate proportion. Examples of the crosslinking agent include aldehyde compounds such as sodium glyoxylate. Examples of the plasticizer include glycerin, ethylene glycol, and propylene glycol.

[0087] As the metal and alloy, general metals and alloys such as Au, Pt, Ag, Cu, and Al can be used.

[0088] The thickness of the electrode 20 may be any appropriate value, for example, 10 μm to 100 μm. When the thickness of the electrode 20 is within the above preferred range, the electrode 20 can have sufficient strength and flexibility, and conductive stability when deformed.

[0089] The thickness of the electrode 20 refers to the length in the direction perpendicular to the surface of the electrode 20, similar to the protrusion 111, the first sheet portion 112, and the second sheet portion 113. The thickness of the electrode 20 may be measured in the same manner as the protrusion 111, the first sheet portion 112, and the second sheet portion 113.

[0090] The area of the electrode 20 may be set to any appropriate size depending on the size of the biosensor 1, for example, 2.0 cm 2 ~5.0cm 2 The area of the electrode 20 may be 2.0 cm 2 ~5.0cm 2 If so, the electrode 20 can have sufficient conductive stability. The method for measuring the area of the electrode 20 is not particularly limited, and a general measurement method such as calculation from a planar image of the electrode can be used.

[0091] (sensor part) As shown in FIG. 3, the sensor section 30 has a flexible substrate 31, a sensor body 32, and connection sections 33A and 33B connected to the sensor body 32.

[0092] The flexible substrate 31 is a resin substrate on which various components for acquiring biological information are mounted, and on the flexible substrate 31, a sensor main body 32 and connection portions 33A and 33B are arranged.

[0093] As shown in FIG. 2, the sensor main body 32 has a component mounting section 321 which is a control section, and a battery mounting section 322, and acquires biological information.

[0094] The component mounting unit 321 has various components mounted on the flexible substrate 31, such as a CPU and integrated circuit that process biosignals acquired from a living body to generate biosignal data, a switch that activates the biosensor 1, a flash memory that stores the biosignals, and a light-emitting element, and acquires bioinformation. Note that examples of circuits using the various components are omitted. The component mounting unit 321 operates using power supplied from a battery 34 attached to the battery attachment unit 322.

[0095] The component mounting unit 321 transmits the information to an external device such as an operation checking device that checks the initial operation, or a reading device that reads the biometric information from the biometric sensor 1, via wire or wirelessly.

[0096] The battery mounting section 322 is disposed between the connection section 33A and the component mounting section 321, and supplies power to an integrated circuit or the like mounted on the component mounting section 321. As shown in FIG. 2, a battery 34 is mounted in the battery mounting section 322.

[0097] The connection portions 33A and 33B have wirings 331A and 331B respectively connected to the sensor main body 32 in the longitudinal direction (Y-axis direction) of the sensor main body 32, and terminal portions 332A and 332B provided at the tip side of the wirings 331A and 331B and connected to the electrodes 20.

[0098] As shown in Fig. 3, one end of the wiring 331A and one end of the wiring 331B are each connected to the electrode 20. As shown in Fig. 3, the other end of the wiring 331A is connected to a switch or the like mounted on the component mounting portion 321 along the outer periphery of the sensor main body 32. The other end of the wiring 331B is connected to a switch or the like mounted on the component mounting portion 321. The wiring 331A and 331B may be formed in a wiring layer on either the front or back side of the flexible substrate 31.

[0099] Terminal portions 332A and 332B are arranged in a state where they are sandwiched between first layer member 10 and second layer member 40, with one end connected to wiring 331A and 331B and the top surface of the other end in contact with electrode 20.

[0100] As shown in FIG. 4, the connection portions 33A and 33B may be formed below the first sheet portion 112 when the biosensor 1 is seen in a plan view.

[0101] A known battery can be used as the battery 34. For example, a coin-type battery such as a CR2025 battery can be used as the battery 34.

[0102] [Second layer member] As shown in FIG. 3, the second layer member 40 is provided on the attachment surface side of the electrode 20 and the sensor unit 30, and serves as a support substrate on which the sensor unit 30 is placed and also forms part of the attachment surface with the skin 2. As shown in FIGS. 1 and 2, the outer shape of both sides of the second layer member 40 in the width direction (X-axis direction) may be substantially the same as the outer shape of both sides of the first layer member 10 in the width direction (X-axis direction). The length (Y-axis direction) of the second layer member 40 is formed shorter than the lengths (Y-axis direction) of the cover member 11 and the upper sheet 12. As shown in FIG. 3, both ends of the second layer member 40 in the longitudinal direction are positioned so that the wiring 331A and 331B of the sensor unit 30 are sandwiched between the second layer member 40 and the upper sheet 12 and overlap part of the electrode 20.

[0103] The second layer member 40 has 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 to have the same shape in a plan view. The second adhesive layer 43 of the second layer member 40 and the electrode 20 form an adhesion surface to the skin 2. Since the waterproofness and moisture permeability vary depending on the area of the electrode 20 and the second adhesive layer 43 and the position on the adhesion surface, and the adhesiveness can be varied, the waterproofness and moisture permeability can be varied and the adhesiveness can be varied depending on the area of the adhesion surface of the second adhesive layer 43.

[0104] (Second base material) The second substrate 41 can be formed using a flexible resin having appropriate elasticity, flexibility, and toughness. Examples of materials that can be used to form the second substrate 41 include polyester-based resins such as polyethylene terephthalate (PET), polybutylene terephthalate, polytrimethylene terephthalate, polyethylene naphthalate, and polybutylene naphthalate; acrylic-based resins such as polyacrylic acid, polymethacrylic acid, polymethyl acrylate, polymethyl methacrylate (PMMA), polyethyl methacrylate, and polybutyl acrylate; polyolefin-based resins such as polyethylene and polypropylene; polystyrene-based 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-based resins; polyurethane-based resins; silicone-based resins; and thermoplastic resins such as polyvinyl chloride and vinyl chloride-vinyl acetate copolymer resins. Among these, polyolefin resins and PET are preferably used. These thermoplastic resins are waterproof and impermeable to moisture and water vapor (low moisture permeability). Therefore, by forming the second base material 41 using these thermoplastic resins, it is possible to prevent sweat or water vapor generated from the skin 2 from passing through the second base material 41 and entering the flexible substrate 31 side of the sensor unit 30 when the biosensor 1 is attached to the skin 2 of the living body.

[0105] The second base material 41 is preferably formed in a flat plate shape because the sensor section 30 is placed on the upper surface side thereof via the lower adhesive layer 42.

[0106] The thickness of the second base material 41 can be selected arbitrarily and may be, for example, 1 μm to 300 μm.

[0107] (Bottom adhesive layer) As shown in FIG. 3 , the lower adhesive layer 42 is provided on the upper surface of the second base material 41 on the cover member 11 side (+Z-axis direction), and the sensor unit 30 is adhered thereto. Both longitudinal ends of the lower adhesive layer 42 of the second layer member 40 are provided at positions facing the opposing portions 20a of the electrodes 20. This allows the opposing portions 20a of the electrodes 20 and the terminal portions 332A and 332B to be sandwiched between the upper sheet 12 and the second layer member 40 in a pressed state, thereby enabling electrical conduction between the electrodes 20 and the terminal portions 332A and 332B. The lower adhesive layer 42 can be made of the same material as the second adhesive layer 43 described below, and therefore details thereof will be omitted. Note that the lower adhesive layer 42 is not necessarily required or may not be provided.

[0108] (2nd adhesive layer) As shown in FIG. 3, the second adhesive layer 43 is provided on the lower surface of the attachment side (−Z axis direction) of the second base material 41, and is a layer that comes into contact with the living body.

[0109] The second adhesive layer 43 preferably has pressure-sensitive adhesive properties. By having pressure-sensitive adhesive properties, the second adhesive layer 43 can easily attach the biosensor 1 to the skin 2 of a living body by pressing the biosensor 1 against the skin 2 of the living body.

[0110] The material for the second adhesive layer 43 is not particularly limited as long as it is a material having pressure-sensitive adhesive properties, and examples thereof include biocompatible materials. Examples of materials for forming the second adhesive layer 43 include acrylic pressure-sensitive adhesives and silicone pressure-sensitive adhesives. Preferably, an acrylic pressure-sensitive adhesive is used.

[0111] 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 monomer component containing a (meth)acrylic acid ester such as isononyl acrylate or methoxyethyl acrylate as a main component and optionally containing a monomer copolymerizable with the (meth)acrylic acid ester such as acrylic acid can be used.

[0112] The acrylic pressure-sensitive adhesive preferably further contains a carboxylic acid ester. The carboxylic acid ester functions as a pressure-sensitive adhesive strength adjuster that reduces the pressure-sensitive adhesive strength of the acrylic polymer and adjusts the pressure-sensitive adhesive strength of the second adhesive layer 43. The carboxylic acid ester may be a carboxylic acid ester that is compatible with the acrylic polymer. Examples of the carboxylic acid ester that may be used include triglycerides of fatty acids.

[0113] The acrylic pressure-sensitive adhesive may contain a crosslinking agent, if necessary. 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.

[0114] The second adhesive layer 43 preferably has excellent biocompatibility. For example, when the second adhesive layer 43 is subjected to a stratum corneum peeling test, the stratum corneum peeling area ratio is preferably 0% to 50%. If the stratum corneum peeling area ratio is within the range of 0% to 50%, even when the second adhesive layer 43 is attached to the skin 2, the load on the skin 2 can be reduced.

[0115] The second adhesive layer 43 is preferably moisture-permeable. Water vapor and the like generated from the skin 2 to which the biosensor 1 is attached can escape to the upper sheet 12 side through the second adhesive layer 43. Furthermore, as described below, the upper sheet 12 has a cellular structure, and therefore water vapor can be released to the outside of the biosensor 1 through the second adhesive layer 43. This makes it possible to prevent sweat or water vapor from accumulating at the interface between the skin 2 to which the biosensor 1 is attached and the second adhesive layer 43. As a result, moisture accumulated at the interface between the skin 2 and the second adhesive layer 43 weakens the adhesive strength of the second adhesive layer 43, making it possible to prevent the biosensor 1 from peeling off from the skin.

[0116] The moisture permeability of the second adhesive layer 43 is, for example, 300 g / (m 2 ·day)~10000g / (m 2 If the moisture permeability of second adhesive layer 43 is within the above-mentioned preferred range, even when second adhesive layer 43 is attached to skin 2, sweat and the like generated from skin 2 can be appropriately transmitted through second adhesive layer 43 to the outside, thereby reducing the burden on skin 2.

[0117] The thickness of the second adhesive layer 43 can be selected arbitrarily and is preferably 10 μm to 300 μm. If the thickness of the second adhesive layer 43 is 10 μm to 300 μm, the biosensor 1 can be made thinner.

[0118] 1 and 2, when the biosensor 1 is not in use, it is preferable to attach a release liner 50 to the adhesive surfaces of the electrode 20 and second substrate 41 that come into contact with the living body in order to protect the electrode 20 and second layer member 40 until use. When in use, the release liner 50 is peeled off from the electrode 20 and second layer member 40, and the adhesive surface of the biosensor 1 is attached to the skin 2. By leaving the release liner 50 attached to the adhesive surface, the adhesive strength of the electrode 20 and second layer member 40 can be maintained even when the biosensor 1 is stored for a long period of time. Therefore, by peeling the release liner 50 from the second layer member 40 and electrode 20 when in use, the adhesive surface can be securely attached to the skin 2 for use.

[0119] There are no particular limitations on the method for manufacturing the biosensor 1, and any appropriate method can be used for manufacturing the biosensor 1. An example of the method for manufacturing the biosensor 1 will be described.

[0120] 1 and 2, a first layer member 10, an electrode 20, a sensor unit 30, and a second layer member 40 are prepared. The first layer member 10, the electrode 20, the sensor unit 30, and the second layer member 40 can be manufactured by any suitable manufacturing method without any particular limitation as long as the method can be used to manufacture each of them.

[0121] There are no particular limitations on the method for manufacturing the cover member 11 that constitutes the first layer member 10, and a general manufacturing method can be used. The cover member 11 may be manufactured using, for example, a 3D printer or the like.

[0122] After preparing the first layer member 10, electrodes 20, sensor unit 30, and second layer member 40 that constitute the biosensor 1 shown in Fig. 1, the sensor unit 30 is placed on the second layer member 40. Then, the first layer member 10, electrodes 20, sensor unit 30, and second layer member 40 are layered in this order from the first layer member 10 side toward the second layer member 40 side. In this way, the biosensor 1 shown in Fig. 1 is obtained.

[0123] 5 is an explanatory diagram showing a state in which the biosensor 1 of FIG. 1 is attached to the chest of a subject P. As shown in FIG. 5, for example, the biosensor 1 is attached to the skin of the subject P with the longitudinal direction (Y-axis direction) aligned with the sternum of the subject P, one electrode 20 on the upper side and the other electrode 20 on the lower side. The biosensor 1 is attached to the skin of the subject P by the second adhesive layer 43 of FIG. 2, and in a state in which the electrodes 20 are pressed against the skin of the subject P, the biosensor 1 acquires biosignals such as electrocardiogram signals from the subject P via the electrodes 20. The biosensor 1 stores the acquired biosignal data in a non-volatile memory such as a flash memory mounted on the component mounting section 321.

[0124] As described above, the biosensor 1 includes the first layer member 10, the electrodes 20, and the sensor body 32. The cover member 11 constituting the first layer member 10 has a first sheet portion 112 and a second sheet portion 113 in a plan view of the biosensor 1. The first sheet portion 112 has a resistance of 0.01 N·mm 2 ~2.0N·mm 2 The second sheet portion 113 has a bending rigidity of 1.0 N·mm 2 ~20N·mm 2 The first sheet portion 112 is thicker than the second sheet portion 113 and therefore has a higher mass and bending rigidity than the second sheet portion 113. Therefore, while the biosensor 1 is attached to the skin 2 of the subject, the first sheet portion 112 exerts a pressing effect on the electrode 20 against the skin 2, allowing the electrode 20 to stably adhere to the skin 2 and maintain its adherence to the skin 2. Furthermore, the second sheet portion 113 is thin and has appropriate flexibility, allowing the biosensor 1 to easily stretch, such as in the longitudinal direction. This improves the adherence of the biosensor 1 to the surface of the skin 2. Therefore, the biosensor 1 gradually follows large deformations of the skin 2 caused by body movement, thereby suppressing peeling from the skin 2 and improving adhesion reliability to the surface of the skin 2 without reducing the wearing comfort, and by bringing the electrode 20 into closer contact with the skin, it is possible to improve skin contact impedance.

[0125] The reliability of adhesion to the surface of the skin 2 can be evaluated by conducting a tensile endurance test, a twist endurance test, a bending endurance test, and the like.

[0126] When conducting a tensile durability test, for example, a high-performance artificial skin model (product name: Bioskin Plate, Viewlux Co., Ltd.) is used as a substitute for skin 2, and the biosensor 1 is attached and fixed. The Bioskin Plate is set in a general surface condition tensile tester such as a small desktop durability tester, and the Bioskin Plate is set so that the strain is a predetermined value (for example, 20%), and is repeatedly stretched once per second until peeling occurs at the edge of the biosensor, and the number of times (number of repetitions) until peeling occurs is measured for evaluation.

[0127] When conducting a torsion durability test, for example, the biosensor 1 is fixed to the above-mentioned BIOSKIN plate and set in a general surface condition no-load torsion tester such as a small tabletop durability tester, and set so that the torsion angle is a predetermined value (for example, 20°).The BIOSKIN plate is then repeatedly twisted, and the number of times (number of repetitions) until peeling occurs is counted to evaluate the durability.

[0128] When performing a bending endurance test, for example, the biosensor 1 is fixed to the above-mentioned bioskin plate and set in a general bending tester such as a small desktop endurance tester so that the bending angle is a predetermined value (for example, 90°) around the longitudinal axis of the housing. Note that when performing a bending endurance test, the biosensor 1 may be performed without the sensor main body 32 inside. Then, the biosensor can be repeatedly bent and the number of times (number of repetitions) until peeling occurs is counted to evaluate the bending endurance.

[0129] When measuring the contact impedance, for example, the electrodes 20 provided in the biosensor 1 are of a predetermined size (4 cm 2 The end of the copper foil tape is attached to the end of the electrode 20, and the other side is fixed with a cable having an alligator clip. After connecting the clip on the other side to an impedance analyzer, the biosensor 1 is attached to the skin 2 of the subject, and the contact impedance with the skin 2 is measured for one minute to perform an evaluation.

[0130] In the biosensor 1, the cover member 11 is formed in a substantially rectangular shape in a plan view of the biosensor 1, and both ends in the longitudinal direction can be rounded. Because both ends in the longitudinal direction of the cover member 11 are easily deformed in response to deformation of the surface of the skin 2, even if the surface of the skin 2 deforms due to body movement, the biosensor 1 is likely to maintain a state of being attached to the surface of the skin 2, thereby further improving the adhesion reliability to the surface of the skin 2. Furthermore, because both ends in the longitudinal direction of the cover member 11 are rounded, even if the surface of the skin 2 deforms due to body movement, the both ends in the longitudinal direction of the biosensor 1 can be prevented from digging into the skin 2, thereby reducing pain to the subject.

[0131] The biosensor 1 can have two sets of notches 13 on the longitudinal side of the cover member 11. This allows the cover member 11 to flexibly deform in response to deformation of the surface of the skin 2 due to body movement, so that the cover member 11 can more reliably maintain its adherence to the surface of the skin 2.

[0132] In the biosensor 1, the thickness of the second sheet portion 113 can be set to 60% or less of the thickness of the first sheet portion 112. This allows the second sheet portion 113 to reliably exhibit flexibility, so that even if the surface of the skin 2 is deformed due to body movement, the biosensor 1 can remain attached to the surface of the skin 2, thereby further improving the reliability of adhesion to the surface of the skin 2.

[0133] In the biosensor 1, the electrode 20 can be provided on the surface facing the skin 2 so as to be disposed within the first sheet portion 112 in a plan view of the biosensor 1. Because the first sheet portion 112 is formed thicker than the second sheet portion 113, the electrode 20 can be in contact with the skin 2 while being pressed against it. This improves contact between the electrode 20 and the skin 2. Furthermore, while the biosensor 1 is attached to the skin 2 of the subject, even if the surface of the skin 2 is deformed due to body movement or the like, the electrode 20 can maintain a stable contact state with the skin 2. Therefore, the biosensor 1 can more stably improve the contact impedance of the electrode 20 and can be stably attached to the subject.

[0134] The biosensor 1 includes a first layer member 10, a first base material 121, a first adhesive layer 122, and an upper adhesive layer 123. The first base material 121 can be formed to have a shape corresponding to the outermost shape of the cover member 11 in a plan view of the biosensor 1. Because the first adhesive layer 122 is adhesive, the electrode 20 can be brought into contact with the surface of the skin 2 while being stably attached to the first layer member 10 by the first adhesive layer 122. This reduces the contact impedance of the electrode 20 with the surface of the skin 2, suppresses noise generation, and allows the biosensor 1 to be more stably attached to the skin 2. Furthermore, because the first base material 121 has a shape corresponding to the outermost shape of the cover member 11, it is possible to prevent only the cover member 11 from coming into contact with the skin 2. Therefore, the biosensor 1 can improve the detection accuracy of biosignals during use and maintain stable adhesion to the living body.

[0135] The biosensor 1 can have a second adhesive layer 43 on the surface of the second layer member 40 opposite to the first layer member 10 side. This allows the second layer member 40 of the biosensor 1 to be attached to the skin 2 via the second adhesive layer 43, thereby reducing the contact impedance of the electrode 20 with the surface of the skin 2. Therefore, the biosensor 1 can further improve the detection accuracy of biosignals during use and can maintain more stable adhesion to the skin 2.

[0136] The surface of the biosensor 1 that is attached to the skin 2 can be formed by the first layer member 10, the electrodes 20, and the second layer member 40. This allows the thickness of the biosensor 1 to be reduced. Therefore, the biosensor 1 can be made smaller and the contact impedance with the surface of the skin 2 can be reduced.

[0137] The biosensor 1 has a bending rigidity of 0.005 N·mm when the thickness of the first substrate 121 is 0.2 mm. 2 ~0.035N·mm 2 Since first base material 121 is flexible and has appropriate bending rigidity, it can flexibly deform in response to deformation of the surface of skin 2 due to body movement, while maintaining a state in which electrode 20 is pressed against skin 2. Therefore, biosensor 1 can reliably maintain a state in which it is attached to the surface of skin 2, maintaining reliable adhesion to the surface of skin 2, and maintaining a low contact impedance between electrode 20 and the surface of skin 2.

[0138] As described above, the biosensor 1 can stably measure bioinformation from the skin 2 for a long period of time during use, and therefore can be effectively used as an adhesive biosensor that is attached to human skin 2. The biosensor 1 can be suitably used, for example, in wearable healthcare devices that are attached to the skin of a living body and require high electrocardiogram detection sensitivity and high suppression of noise generated in the electrocardiogram.

[0139] In this embodiment, the configuration of the cover member 11 is not limited to the configuration shown in Fig. 1 etc., as long as it has the first sheet portion 112 and the second sheet portion 113. Other examples of the configuration of the cover member 11 are shown below.

[0140] For example, as shown in FIG. 6, the cover member 11 does not have to have the notch 13 on the side surface in the longitudinal direction.

[0141] As shown in FIG. 7, the cover member 11 may be formed in a rectangular shape with rounded corners of the first sheet portion 112 and the second sheet portion 113 in a plan view, without having any notch portions 13 on the longitudinal side surfaces.

[0142] As shown in Figure 8, when viewed in a plane, the cover member 11 has a rectangular shape with the first sheet portion 112 and the second sheet portion 113 formed in a semicircular shape at both ends in the longitudinal direction, and the second sheet portion 113 may be formed only at both ends in the longitudinal direction of the cover member 11.

[0143] Although the embodiments have been described above, they are presented as examples and the present invention is not limited to the above embodiments. The above embodiments can be implemented in various other forms, and various combinations, omissions, substitutions, modifications, etc. can be made without departing from the spirit of the invention. These embodiments and their modifications are included within the scope and spirit of the invention, and are also included in the scope of the invention and its equivalents as set forth in the claims. [Example]

[0144] 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.

[0145] <Fabrication of biosensors> [Example 1] (Production of cover member) A cover member having the shape shown in Figure 4 was designed using 3D CAD design software (SolidWorks). A 3D printer (Object260, STRATASYS. Ltd.) was used to fabricate the cover member 1-1. The cover member 1-1 was formed using the 3D printer into a roughly rectangular shape with a rounded tip in a plan view. The cover member 1-1 was formed to have a protruding portion protruding in the height direction in the longitudinal center, a first sheet portion around the protruding portion that was one step lower than the protruding portion, and a second sheet portion thinner than the first sheet portion. The storage section was formed to have a protruding portion protruding in the height direction in the longitudinal center, and a first sheet portion formed to slope from the protruding portion toward the second sheet portions located on both tip ends. The width was 40 mm and the total length was 124 mm. The cover member was fabricated to have a Shore D hardness of 40 mm. The thickness of the first sheet portion was 2 mm and the width was 30 mm. The thickness of the second sheet portion was 1 mm and the width was 5 mm. The width of the first sheet portion was the maximum distance in the short direction of the cover member 1-1. The width of the second sheet portion was the maximum distance between the outer shape of the first sheet portion and the outer shape of the second sheet portion. The dimensions of the cover member 1-1 in a plan view are shown in Figure 9.

[0146] -Measurement of bending rigidity- First, the Young's modulus of the acrylic resin used to prepare the cover member was measured. A film measuring 10 cm long x 10 cm wide x 1 mm thick was produced using a 3D printer (Object260, STRATASYS.Ltd.) from the acrylic resin. The film was then cut into a 5 cm long x 1 cm wide sample to prepare a sample for measuring Young's modulus. The sample was placed in a tensile tester, and both ends of the sample in the longitudinal direction were fixed with chucks so that the distance between the chucks was 2 cm. One of the chucks was then pulled in the longitudinal direction of the sample at a tensile speed of 300 mm / min, and the Young's modulus was measured by an elongation test.

[0147] Next, the bending rigidity of the acrylic resin used to produce the cover member was calculated using the calculated Young's modulus based on the following calculation formula (1). Bending rigidity = Young's modulus × moment of inertia: length 10 mm (1)

[0148] (Preparation of first laminate sheet) A double-sided adhesive tape (KE311, Nitto Denko Corporation, thickness: 60 μm) was attached as a first adhesive layer to the underside of a polyurethane sheet (Esmer URS, Nihon Matai Co., Ltd., thickness: 30 μm) formed into a rectangular shape with rounded ends as the first substrate. The double-sided adhesive tape had an adhesive (acrylic resin) formed on its surface. Then, a silicone tape (ST503(HC)60, Nitto Denko Corporation, thickness: 60 μm) was attached as an upper adhesive layer to the upper surface of the porous substrate to prepare an upper sheet.

[0149] (Electrode preparation) 1. Preparation of Conductive Composition 1.0 g of conductive polymer PEDOT / PSS pellets (Orgacon DRY, manufactured by Agfa Materials Japan) and 23 g of water were added to a cup and stirred for 10 minutes at 2000 rpm using a stirring mixer (Thinky Corporation). Next, 12.0 g of emulsion-based adhesive (2EHA / MMA / AA / =90 / 10 / 4, solids concentration 52%) and 2.0 g of glycerin were added as binder resins, and the mixture was stirred, mixed, and degassed again at 2200 rpm for 10 minutes using the stirring mixer to prepare a uniform aqueous conductive composition solution A with a solids concentration of 24%.

[0150] The contents of the conductive polymer, binder resin, and plasticizer relative to 100.0 parts by mass of the conductive composition were 10.8 parts by mass, 72.5 parts by mass, and 16.7 parts by mass, respectively.

[0151] 2. Preparation of Electrode Sheet The prepared aqueous solution of conductive composition A was applied using an applicator to a polyethylene terephthalate (PET) film (PET-50-SCA1, manufactured by Fujiko Co., Ltd., 50 μm thick) that had been surface-treated with a silicone-based release agent. The PET film coated with the aqueous solution of conductive composition A was then transported to a drying oven (SPHH-201, manufactured by ESPEC Co., Ltd.), where the aqueous solution of conductive composition A was heated and dried at 135°C for 3 minutes to produce a cured product of the conductive composition. The cured product was then stamped (pressed) into the desired shape to form a sheet, producing an electrode sheet (bioelectrode) with a thickness of 20 μm.

[0152] The contents of the conductive polymer, binder resin, and plasticizer contained in the electrode sheet were the same as those of the conductive composition, 11.2 parts by mass, 29.6 parts by mass, and 59.2 parts by mass, respectively.

[0153] (Preparation of second laminated sheet) A rectangular second substrate (PET (PET-50-SCA1 (white), manufactured by Fujiko Co., Ltd.), thickness: 50 μm) was coated on both sides with adhesive (Permirol, manufactured by Nitto Denko Corporation), moisture permeability: 21 g / (m 2 A lower adhesive layer and a second adhesive layer were formed by attaching the adhesive film to the second laminate sheet.

[0154] (Fabrication of biosensors) A sensor unit equipped with a battery and a control unit was placed in the center of the upper surface of the second laminate sheet. Then, a pair of electrodes was attached to the adhesive surface of the first adhesive layer while sandwiched between the first laminate sheet and the second laminate sheet, and the electrodes and wiring of the sensor unit were connected. The sensor unit was then placed in the storage space formed by the first laminate sheet and the cover member, and a cover member was laminated on the first laminate sheet so that the connection portion was positioned within approximately the first sheet portion of the cover member in a plan view of the biosensor, thereby producing a biosensor.

[0155] [Examples 2 and 3] A biosensor was fabricated in the same manner as in Example 1, except that the configuration of cover member 1-1 was changed to that shown in Table 1 to fabricate cover members 1-2 and 1-3.

[0156] [Examples 4 and 5] In place of the cover member 1-1 in Example 1, cover members 2-1 and 2-2 were fabricated by molding into a predetermined shape as shown in Fig. 6 and having the details shown in Table 1. Except for this, a biosensor was fabricated in the same manner as in Example 1. The dimensions of the cover members 2-1 and 2-2 in a plan view are shown in Fig. 10.

[0157] [Example 6] In place of the cover member 1-1 in Example 1, a cover member 3 was produced by molding into a predetermined shape as shown in Fig. 7 and having the details shown in Table 1. A biosensor was produced in the same manner as in Example 1 except for that. The dimensions of the cover member 3 in a plan view are shown in Fig. 11.

[0158] [Example 7] In place of the cover member 1-1 in Example 1, a cover member 4 was produced by molding into a predetermined shape as shown in FIG. 8 and having the details shown in Table 1. A biosensor was produced in the same manner as in Example 1 except for that. The dimensions of the cover member 4 in a plan view are shown in FIG. 12.

[0159] [Example 8] In Example 1, instead of the cover member 1-1, a plurality of molded bodies were formed using a styrene-based elastomer (Hybler 5127, Kuraray Co., Ltd.) and stacked together, heated to 120°C, and then fused by applying pressure from above to produce a cover member 1-4 having the details shown in Table 1. A biosensor was produced in the same manner as in Example 1 except for the above.

[0160] [Comparative Example 1] A biosensor was produced in the same manner as in Example 1, except that the configuration of the cover member 1-1 in Example 1 was changed to that shown in Table 1 to produce a cover member 1-5.

[0161] Comparative Example 2 In place of the cover member 1-1 in Example 1, a cover member 2-3 was produced by molding into a predetermined shape as shown in Fig. 6 and having the details shown in Table 1. Otherwise, the same procedure as in Example 1 was carried out to produce a biosensor.

[0162] [Comparative Examples 3 and 4] In place of the cover member 1-1 in Example 1, cover members 5-1 and 5-2 were produced by molding into a predetermined shape as shown in Fig. 9 and having the details shown in Table 1. Except for this, a biosensor was produced in the same manner as in Example 1. The dimensions of the cover members 5-1 and 5-2 in a plan view are shown in Fig. 13.

[0163] Comparative Example 5 In Example 1, instead of the cover member 1-1, a styrene-based resin was used for molding to produce a cover member 1-6 having the details shown in Table 1. Otherwise, the same procedures as in Example 1 were carried out to produce a biosensor.

[0164] Comparative Example 6 In Example 1, instead of the cover member 1-1, a silicone resin (KE-1950-40A / B, Shin-Etsu Silicone Co., Ltd.) was poured into a mold created with a 3D printer and molded into a predetermined shape as shown in Fig. 9 to produce a cover member 5-3 having the details shown in Table 1. Other than that, the same procedures as in Example 1 were carried out to produce a biosensor.

[0165] Comparative Example 7 A biosensor was fabricated in the same manner as in Example 1, except that the styrene-based resin used for the material of the first substrate was changed to a urethane-based resin.

[0166] [Comparative Example 8] A biosensor was fabricated in the same manner as in Example 1, except that the styrene-based resin used for the material of the first substrate was changed to a silicone-based resin.

[0167] Table 1 shows the type, material, size and bending strength of the cover member of the biosensor of each of the above examples and comparative examples, as well as the material and bending strength of the first base material.

[0168] <Evaluation of biosensor characteristics> The biosensors of the above examples and comparative examples were used to measure and evaluate the adhesive reliability and contact impedance. The adhesive reliability was evaluated by conducting a tensile durability test, a torsion durability test, and a bending durability test. The measurement results of each characteristic are shown in Table 1.

[0169] [Adhesion reliability] 1. Tensile endurance test A high-performance artificial skin model (Beaulux Corporation, product name: Bioskin Plate, hereafter referred to as Bioskin Plate) was used as a skin substitute, and a biosensor was attached and fixed to it. The Bioskin Plate was placed in a small tabletop durability testing machine (Yuasa System Equipment Co., Ltd., surface condition tensile testing machine) and set to a strain of 20%. The Bioskin Plate was repeatedly stretched once per second until peeling occurred at the edge of the biosensor. The number of times until peeling occurred was counted and evaluated based on the following criteria. The maximum number of repeated stretches of the Bioskin Plate was 500. If the number of times until peeling occurred was 300 or more, it was evaluated as being almost stable while attached to the living body and capable of acquiring biosignals in a generally stable manner (denoted as A, B, or C in Table 1). (Evaluation criteria) A: The number of times required to peel off exceeds 400. B: The number of times until peeling occurs is more than 300 and not more than 400. C: The number of times until peeling occurs is more than 200 and 300 or less. D: The number of times until peeling occurs is more than 100 and 200 or less. E: The number of times until peeling occurs is 100 or less.

[0170] 2.Twist durability test The biosensor was fixed to the Bioskin plate and set in a small tabletop durability tester (surface condition no-load twist tester), set so that the twist angle was 20°, and repeatedly twisted to check the number of times until peeling occurred, and evaluated based on the following evaluation criteria. The maximum number of repeated twists of the Bioskin plate was 300. If the number of times until peeling occurred was 50 or more, it was evaluated as being almost stable while attached to the living body and capable of acquiring biosignals in a fairly stable manner (represented as A, B, or C in Table 1). (Evaluation criteria) A: The number of times required to peel off exceeds 250. B: The number of times until peeling occurs is more than 150 times but not more than 250 times. C: The number of times until peeling occurs is more than 50 times and 150 times or less. D: The number of times until peeling occurs is more than 10 times and not more than 50 times. E: The number of times required for peeling to occur is 10 or less.

[0171] 3. Bending endurance test The biosensor without the sensor body was fixed to the Bioskin plate and set in a small tabletop durability tester (bending tester), set so that the bending angle was 90 degrees around the longitudinal axis of the housing, and bent repeatedly to check the number of times until peeling occurred, and evaluated based on the following evaluation criteria. The Bioskin plate could be bent repeatedly up to 100 times. (Evaluation criteria) A: The number of times required to peel off is more than 90. B: The number of times until peeling occurs is more than 70 times but not more than 90 times. C: The number of times until peeling occurs is more than 40 times but not more than 70 times. D: The number of times until peeling occurs is more than 20 times but not more than 40 times. E: The number of times until peeling occurs is 20 or less.

[0172] [Contact impedance measurement] Area 4cm 2A biosensor was created using electrodes cut to 10 cm in length. The end of a copper foil tape cut to a width of 5 mm and a length of 10 cm was attached to the end of the electrode, and the other side was fixed with a cable equipped with an alligator clip. After connecting the opposite clip to an impedance analyzer (IM3570, manufactured by Hioki E.E. Corporation), the biosensor was attached to the subject's inner arm, and the contact impedance with the skin was measured for 1 minute and evaluated based on the following criteria. (Evaluation criteria) A: The contact impedance is 20kΩ or less. B: The contact impedance is greater than 20 kΩ and less than 30 Ω. C: The contact impedance is greater than 30 kΩ and less than 40 Ω. D: The contact impedance is greater than 40 kΩ and less than 50 Ω. E: Contact impedance exceeds 50kΩ.

[0173] [comprehensive evaluation] The overall evaluation was based on the following evaluation criteria: a biosensor with an overall evaluation of A was judged to be extremely excellent, a biosensor with an overall evaluation of B was judged to be excellent, a biosensor with an overall evaluation of C was judged to be slightly better than conventional biosensors, a biosensor with an overall evaluation of D was judged to be insufficient for practical use as a biosensor, and a biosensor with an overall evaluation of E was judged to be unsuitable for practical use as a biosensor. (Evaluation criteria) A: Three or more A's in all evaluation items, with the remainder being B's. B: Of all the evaluation items, there are two A's and the rest are B's. C: Of all evaluation items, there are two A's and the rest include C or D. D: Of all evaluation items, there is one B and two or more Ds. E: Of all evaluation items, there are two or more E's, and the rest are B, C, or D.

[0174] [Table 1]

[0175] As can be seen from Table 1, in each example, the tensile durability, torsional durability, bending durability, and contact impedance with the artificial skin all met the evaluation conditions. On the other hand, in each comparative example, at least one of the tensile durability, torsional durability, bending durability, and contact impedance with the artificial skin did not meet the evaluation conditions.

[0176] Therefore, the biosensor of each of the above examples was able to improve the adhesion reliability to the skin surface and also improve the contact impedance by configuring the first sheet portion and the second sheet portion of the cover member to be equal to or less than a predetermined value. Therefore, it can be said that the biosensor according to this embodiment can be effectively used for measuring an electrocardiogram continuously for a long period of time, even if it is attached to the skin of a subject for a long period of time (for example, 24 hours).

[0177] The embodiments of the present invention are as follows, for example. <1> A biosensor to be attached to a living body, a sensor body for acquiring biological information; an electrode connected to the sensor body; a first layer member having a storage space for storing the sensor body and an opening of the storage space, and a cover member having a longitudinal direction; the cover member has a first sheet portion formed in a region including the electrodes outside the storage space in a plan view of the biosensor, and a second sheet portion formed on at least both longitudinal end sides of the periphery of the first sheet portion and having a thickness thinner than the first sheet portion; The bending rigidity of the first sheet portion is 0.01 N·mm 2 ~2.0N·mm 2 and The bending rigidity of the second sheet portion is 1.0 N·mm 2 ~20N·mm 2 This is a biosensor. <2> The cover member is formed in a rectangular shape in a plan view, and both ends or corners in the longitudinal direction are rounded. <1> The biosensor according to claim 1. <3> The cover member has one or more notches on its longitudinal side. <1> or <2> The biosensor according to claim 1. <4> The thickness of the second sheet portion is 60% or less of the thickness of the first sheet portion. <1> ~ <3> 10. The biosensor according to claim 9, wherein the first electrode is a first electrode. <5> The electrode is provided on a surface of the first sheet portion facing the living body in a plan view of the biosensor. <1> ~ <4> 10. The biosensor according to claim 9, wherein the first electrode is a first electrode. <6> The first layer member is a first base material provided on the opening side of the cover member and having a through hole at a position corresponding to the storage space; a first adhesive layer provided on the surface of the first base material facing the living body, to which the electrode is attached; an upper adhesive layer that attaches the cover member and the first base material; Equipped with The first base material has a shape corresponding to the outermost shape of the cover member in a plan view of the biosensor. <1> ~ <5> 10. The biosensor according to claim 9, wherein the first electrode is a first electrode. <7> a second layer member attached to a surface of the first base opposite to the cover member so as to expose the electrodes and cover the sensor body; The second layer member has a second adhesive layer on the surface opposite to the first substrate. <6> The biosensor according to claim 1. <8> The electrode, the first base material, and the second layer member form a surface to be attached to a living body. <7> The biosensor according to claim 1. [Explanation of symbols]

[0178] 1. Biometric sensors 2 skin 10 First layer member 11 Cover member 12 Upper seat 12a, 121a, 122a through hole 20, 20A, 20B electrode 20a Opposite part 20b Exposed part 30 Sensor unit 31 Flexible PCB 32 Sensor body 33A connection 33A, 33B connection 34 Battery 40 Second layer member 41 Second base material 42 Lower adhesive layer 43 Second adhesive layer 111 Protrusion 111a Depression 112 First seat section 113, 113A, 113B, 113C Second seat section 121 1st base material 122 1st adhesive layer 123 Upper adhesive layer 321 Parts mounting section 322 Battery compartment 331A, 331B wiring 332A, 332B terminal section

Claims

1. A biosensor to be attached to a living body, a sensor body for acquiring biological information; an electrode connected to the sensor body; a first layer member having a cover member having a longitudinal direction, the cover member having a storage space in which the sensor main body is stored and an opening of the storage space; the cover member has a first sheet portion formed in a region including the electrodes outside the storage space in a plan view of the biosensor, and a second sheet portion formed on at least both longitudinal end sides of an outer periphery of the first sheet portion and having a thickness thinner than the first sheet portion; The bending rigidity of the first sheet portion is 0.01 N mm ２ ~2.0 N mm ２ and The bending rigidity of the second sheet portion is 1.0 N mm ２ ~20N・mm ２ This is a biosensor.

2. The biosensor according to claim 1 , wherein the cover member is formed in a rectangular shape in a plan view, and both ends or corners in the longitudinal direction are rounded.

3. The biosensor according to claim 2 , wherein the cover member has one or more notches on a side surface in the longitudinal direction.

4. 2. The biosensor according to claim 1, wherein the thickness of the second sheet portion is 60% or less of the thickness of the first sheet portion.

5. The biosensor according to claim 1 , wherein the electrodes are provided on a surface of the first sheet portion that faces the living body in a plan view of the biosensor.

6. The first layer member is a first base material provided on the opening side of the cover member and having a through hole at a position corresponding to the storage space; a first adhesive layer provided on the living body side surface of the first base material, to which the electrode is attached; an upper adhesive layer that bonds the cover member and the first base material; Equipped with The biosensor according to claim 1 , wherein the first base material has a shape corresponding to an outermost shape of the cover member in a plan view of the biosensor.

7. a second layer member attached to a surface of the first base opposite to the cover member so as to expose the electrodes and cover the sensor body; The biosensor according to claim 6 , wherein the second layer member has a second adhesive layer on a surface opposite to the first substrate.

8. The biosensor according to claim 7 , wherein the electrode, the first base material, and the second layer member form a surface to be attached to a living body.

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