Biological sensor

Abstract

A biological sensor (1) according to the present invention is a biological sensor (1) that is attached to a living body, and is provided with: a sensor main body (32) for acquiring biological information; a first layer member (10) having a shape protruding so as to cover the sensor body (32); a second layer member (40) which is attached to the surface of the first layer member (10) on the opposite side from the direction in which the second layer member protrudes, and which has an attachment surface for attaching to the living body; and a housing space (S) which is enclosed by the first layer member (10) and the second layer member (40) and which houses the sensor body (32). The moisture permeability at a first temperature of water vapor entering the storage space (S) via the second layer member (40) is smaller than the moisture permeability at a second temperature of water vapor discharged from the storage space (S) via the first layer member (10), and the second temperature is lower than the first temperature.

Description

Technical Field

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

[0002] Biosensors that measure biological information, such as electrocardiogram (ECG) waveforms, pulse waves, brain waves, and myoelectricity, are used in medical institutions such as hospitals and clinics, nursing facilities, and private homes. These biosensors are equipped with bioelectrodes that contact the subject's body to acquire biological information. To measure biological information, the biosensor is attached to the subject's skin, and the bioelectrodes acquire electrical signals related to the biological information.

[0003] As such a biosensor, for example, a biosensor having a sensor body, electrodes, a first layer component and a second layer component is disclosed, wherein the first layer component is formed so as to stack a cover on an upper sheet and has a space capable of accommodating the sensor body, and the second layer component is formed so as to be attached to the surface of the first layer component on the bioside, and the electrodes are exposed while the sensor body is set (for example, refer to patent document 1).

[0004] In this biosensor, a first adhesive layer is provided on the surface of a first layer component that is opposite to the biomolecule, and a second adhesive layer is provided on the surface of a second layer component that is opposite to the biomolecule. The first adhesive layer and the second adhesive layer are attached to the skin, and biomolecule information is obtained by using electrodes attached to the first adhesive layer in a state of being exposed from the second layer component.

[0005] Patent Document 1: Japanese Patent No. 6947955 Summary of the Invention

[0006] <Problems to be Solved by the Invention>

[0007] When the biosensor disclosed in Patent Document 1 is attached to the skin of a subject, water vapor generated by perspiration from the skin may pass through the space within the biosensor and adhere to the sensor body and other components disposed within the biosensor. In order for the biosensor to stably measure electrical signals related to the subject's biological information, it is important to prevent condensation from forming on the sensor body and other components caused by water vapor passing through the space within the biosensor.

[0008] One aspect of the present invention is to provide a biosensor capable of reducing condensation on components disposed in a space within the biosensor.

[0009] <Methods used to solve the problem>

[0010] One aspect of the present invention is a biosensor, which is a biosensor attached to a living body, comprising:

[0011] A sensor body for acquiring biological information;

[0012] a first layer member having a shape protruding so as to cover the sensor body;

[0013] a second layer member attached to a surface of the first layer member on a side opposite to the protruding direction and having an attachment surface for attachment to the living body; and

[0014] a receiving space, enclosed by the first layer component and the second layer component, for receiving the sensor body;

[0015] A moisture permeability of water vapor entering the storage space through the second layer component at a first temperature is smaller than a moisture permeability of water vapor discharged from the storage space through the first layer component at a second temperature, wherein the second temperature is lower than the first temperature.

[0016] <Effects of the Invention>

[0017] According to one aspect of the biosensor of the present invention, condensation on components arranged in a space within the biosensor can be reduced. BRIEF DESCRIPTION OF THE DRAWINGS

[0018] Figure 1 1 is a perspective view showing the overall structure of a biosensor according to an embodiment of the present invention.

[0019] Figure 2 1 is a plan view showing an example of each component of the biosensor.

[0020] Figure 3 is a cross-sectional view of the biosensor in the longitudinal direction, and is Figure 1 II sectional view.

[0021] Figure 4 It shows that Figure 1 An explanatory diagram showing the state where the biosensor is attached to the chest of a subject. DETAILED DESCRIPTION

[0022] The following describes embodiments of the present invention in detail. It should be noted that, to facilitate understanding, identical components are denoted by identical reference numerals in the accompanying drawings, and duplicate descriptions are omitted. Furthermore, the scales of components in the accompanying drawings may differ from the actual scale. In this specification, the term "to" indicating a numerical range indicates that the numerical values ​​preceding and following it include both the lower and upper limits, unless otherwise specified.

[0023] <Biosensor>

[0024] The biosensor according to this embodiment will be described. It should be noted that the term "biological body" refers to the human body (human) as well as animals such as cows, horses, pigs, chickens, dogs, and cats. The biosensor according to this embodiment can be used with biological bodies, and is particularly suitable for use with the human body. In this embodiment, the case where the biological body is a human will be described as an example.

[0025] The biosensor according to this embodiment is an adhesive biosensor that measures biological information by attaching the biosensor to a portion of a living body (such as the skin, scalp, or forehead). This embodiment describes a case in which an electrical signal (biosignal) related to a person's biological information is measured by attaching the biosensor to the person's skin.

[0026] Figure 1 It is a perspective view showing the overall structure of the biosensor according to this embodiment. Figure 1 The left side of FIG shows the appearance of the biosensor according to this embodiment, and Figure 1 The right side of FIG. 1 shows an exploded state of the components of the biosensor according to this embodiment. Figure 2 1 is a plan view showing an example of each component of the biosensor. Figure 3 is a cross-sectional view of the biosensor in the longitudinal direction, and is Figure 1 II sectional view.

[0027] like Figure 1 and Figure 2 As shown in FIG. 1 , the biosensor 1 is a plate-like (sheet-like) component formed into a substantially elliptical shape when viewed from above. Figure 2 and Figure 3 As shown, biosensor 1 includes a first layer member 10, an electrode 20, a sensor portion 30, and a second layer member 40. The first layer member 10, the electrode 20, and the second layer member 40 are stacked sequentially from the first layer member 10 side toward the second layer member 40 side. In biosensor 1, a storage space S is formed, which is surrounded by the first layer member 10, the electrode 20, and the second layer member 40. In biosensor 1, the first layer member 10, the electrode 20, and the second layer member 40 form an attachment surface for attachment to skin 2, a living body. With the attachment surface attached to skin 2, biosensor 1 measures an electrical signal (biosignal) related to the subject's biological information by measuring the potential difference (polarization voltage) between skin 2 and electrode 20.

[0028] exist Figures 1 to 3In the present invention, a three-dimensional orthogonal coordinate system with three axes (X-axis, Y-axis, and Z-axis) is used. The width direction of the biosensor 1 is set as the X-axis direction, the length direction is set as the Y-axis direction, and the height direction (thickness direction) is set as the Z-axis direction. The direction opposite (outward) to the side (attachment side) of the biosensor 1 attached to the biological body (test subject) is represented as the +Z-axis direction, and the attachment side is represented as the -Z-axis direction. In the following description, for convenience, the +Z-axis direction may be represented as the upper side or up, and the -Z-axis direction may be represented as the lower side or down, but this does not necessarily indicate a universal up-down relationship.

[0029] Note that biological signals are electrical signals representing, for example, electrocardiogram waveforms, brain waves, and pulses.

[0030] Furthermore, the biosensor 1 may not include the electrodes 20 as long as it can measure biosignals using infrared rays or the like using the sensor unit 30 . In this case, the storage space S may be formed by being surrounded by the first layer member 10 and the second layer member 40 .

[0031] The biosensor 1 ensures that the moisture permeability of water vapor entering the storage space S through the second layer member 40 (hereinafter referred to as "first moisture permeability M1") at a first temperature T1 (hereinafter referred to as "first moisture permeability M1") is lower than the moisture permeability of water vapor discharged from the storage space S through the first layer member 10 at a second temperature T2 (hereinafter referred to as "second moisture permeability M2") Therefore, in the biosensor 1, water vapor generated by perspiration on the surface of the skin 2 is easily discharged to the outside through the storage space S of the biosensor 1, thereby preventing condensation from forming in the sensor section 30 disposed in the biosensor 1.

[0032] The first temperature T1 is the same or substantially the same temperature as the skin 2 , and is, for example, 33°C to 38°C, preferably 35°C to 37°C, and more preferably about 36°C.

[0033] The second temperature T2 is a temperature lower than the first temperature T1, for example, 27°C to 32°C, preferably 29°C to 31°C, and more preferably about 30°C.

[0034] In the biosensor 1, the first layer member 10, the electrodes 20, and the second layer member 40 form the attachment surface for attachment to the skin 2. Therefore, the first layer member 10, the electrodes 20, and the second layer member 40 constitute the attachment surface. Of these components, the second layer member 40 generates the most water vapor from sweat produced on the skin 2. This second layer member 40 is located closest to the skin 2 and has the sensor unit 30 mounted thereon. Because the moisture permeability of water vapor entering the storage space S from the skin 2 roughly corresponds to the moisture permeability of the second layer member 40, the first moisture permeability M1 is the moisture permeability of the second layer member 40 at the first temperature.

[0035] In the biosensor 1, a moisture-permeable membrane 13 is provided on the first layer member 10. As described below, the moisture-permeable membrane 13 has a higher moisture permeability than the first layer member 10. Since the moisture permeation rate of water vapor discharged from the storage space S to the outside through the first layer member 10 substantially corresponds to the moisture permeation rate of the moisture-permeable membrane 13, the second moisture permeation rate M2 is the moisture permeation rate of the moisture-permeable membrane 13 at the second temperature.

[0036] As described above, the first moisture permeability M1 is the moisture permeability of water vapor entering the storage space S through the second layer component 40, which forms at least a portion of the attachment surface. Therefore, the first moisture permeability M1 can be considered to be the moisture permeability of the second layer component 40 at the first temperature T1.

[0037] As described above, the second moisture permeability M2 is the moisture permeability of water vapor exhausted from the storage space S through the first layer component 10 at the second temperature T2, and is affected by the moisture permeability of the moisture-permeable membrane 13 having a relatively high moisture permeability in the first layer component 10. Therefore, the second moisture permeability M2 can be considered to be the moisture permeability of the moisture-permeable membrane 13 at the second temperature T2.

[0038] In addition, the moisture permeability is calculated|required by the following formula (1).

[0039] Moisture permeability [g / day] = moisture permeability [g / (m 2 ·day)]×surface area [m 2 ](1)

[0040] That is, the first moisture permeability M1 is obtained by the following formula (1-1).

[0041] First moisture permeability M1 [g / day] = moisture permeability of the second layer 40 [g / (m 2 ·day)]×surface area of ​​the second layer component 40 in bottom view [m 2 ](1-1)

[0042] The second moisture permeability M2 is calculated by the following formula (1-2): The surface area of ​​the through-hole 111b provided in the protruding portion 111 of the cover member 11 represents the surface area of ​​the moisture-permeable membrane 13 exposed from the through-hole 111b.

[0043] Second moisture permeability M2 [g / day] = moisture permeability of the moisture permeable film 13 [g / (m 2 ·day)]×the surface area of ​​the through hole 111b provided on the protruding portion 111 of the cover member 11 [m 2 ](1-2)

[0044] [First layer components]

[0045] like Figure 1 and Figure 2 As shown, the first layer component 10 includes a cover component 11, an upper sheet 12, and a moisture-permeable film 13. The first layer component 10 has a space inside thereof to cover the sensor body 32 included in the sensor unit 30, and has a Figure 1 The upper sheet 12 has a shape that is slightly larger than the cover member 11 in a plan view.

[0046] (Cover part)

[0047] like Figure 3 As shown, the cover member 11 is located at the outermost side (+Z axis direction) of the biosensor 1 and is adhered to the upper surface of the upper sheet 12. The cover member 11 has a central portion in the longitudinal direction (Y axis direction) facing the outermost side. Figure 1 The cover member 11 includes a protrusion 111 that protrudes in a substantially dome-shaped manner in the height direction (+Z-axis direction), and flat portions 112A and 112B provided at both ends in the length direction (Y-axis direction). The upper and lower surfaces of the protrusion 111 and the upper and lower surfaces of the flat portions 112A and 112B can be formed flat.

[0048] The cover member 11 has an opening on the inner side (attachment side) of the protrusion 111. This opening is formed as a recess 111a formed in a concave shape on the side facing the skin 2. The recess 111a has at least a portion of a storage space S and is sized to accommodate at least a portion of the sensor unit 30. In other words, the storage space S for accommodating the sensor unit 30 is formed on the inner side (attachment side) of the protrusion 111 by the recess 111a on the inner surface of the protrusion 111, the electrode 20, and the second layer member 40.

[0049] The cover member 11 may have a through hole 111b in the recess 111a that communicates with the storage space S. The size of the through hole 111b is not particularly limited and may be any appropriate size. Furthermore, the shape of the through hole 111b is not particularly limited and may be, for example, circular, rectangular, or elliptical.

[0050] The cover member 11 can generally be formed using a flexible material such as cross-linked rubber. Examples of cross-linked rubber include silicone rubber, fluororubber, urethane rubber, natural rubber, propylene rubber, butadiene rubber, isoprene rubber, styrene-butadiene copolymer rubber, nitrile rubber, hydrated nitrile rubber, chloroprene rubber, ethylene-propylene copolymer rubber, chlorinated polyethylene rubber, chlorosulfonated polyethylene rubber, butyl rubber, and halogenated butyl rubber. Furthermore, the cover member 11 can be formed by using a base resin such as polyethylene terephthalate (PET) as a support and laminating the above-mentioned flexible material on the surface of the support. By forming the cover member 11 using the above-mentioned flexible material, while protecting the sensor portion 30 arranged in the storage space S of the cover member 11, it absorbs impacts applied to the biosensor 1 from the upper surface side, thereby mitigating the impacts applied to the sensor portion 30.

[0051] The thickness of the upper surface and sidewall of the protrusion 111 may be thicker than that of the flat portions 112A and 112B. This allows the protrusion 111 to be less flexible than the flat portions 112A and 112B, thereby protecting the sensor section 30 from external forces applied to the biosensor 1.

[0052] The thickness of the upper surface and sidewall of the protrusion 111 can be appropriately designed, for example, 1.5 mm to 3 mm. The thickness of the flat portions 112A and 112B can also be appropriately designed, for example, 0.5 mm to 1 mm.

[0053] Because the thin flat portions 112A and 112B are more flexible than the protruding portion 111, when the biosensor 1 is attached to the skin 2, it easily deforms in accordance with the surface deformation of the skin 2 caused by body movements such as stretching, bending, and twisting. This reduces the stress applied to the flat portions 112A and 112B when the surface of the skin 2 deforms, making it less likely that the biosensor 1 will peel off the skin 2.

[0054] The outer periphery of the flat portions 112A and 112B may have a shape in which the thickness gradually decreases toward the edges. This further enhances the flexibility of the outer periphery of the flat portions 112A and 112B, improving the wearing comfort of the biosensor 1 when attached to the skin 2 compared to a case where the thickness of the outer periphery of the flat portions 112A and 112B is not reduced. It should be noted that, as will be described later, the upper sheet 12 can reduce the stress applied to the flat portions 112A and 112B when the surface of the skin 2 deforms.

[0055] The moisture permeability of the cover member 11 is 350 g / (m 2 ·day) or less, preferably 330g / (m2 ·day) or less, more preferably 310g / (m 2 If the moisture permeability of the cover member 11 is 350g / (m 2 ·day) or less, when water vapor generated by 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 .

[0056] The method for calculating the moisture permeability of the cover member 11 is not particularly limited, and a general method can be used. For example, the moisture permeability can be calculated according to the following procedure.

[0057] (1) Prepare a weighing bottle having an opening of a predetermined area S, and pour enough water into the weighing bottle so that the liquid level is below the opening.

[0058] (2) A part or all of the cover member 11 is placed as a measurement sample on the entire surface of the opening of the weighing bottle so as not to generate tension on the cover member 11 , and the measurement sample is fixed to the weighing bottle, and the weighing bottle is sealed.

[0059] (3) Immediately after sealing, measure the total mass M1 of the test sample, water and weighing bottle.

[0060] (4) Place the sealed weighing bottle at 40°C and 30% RH for 24 hours.

[0061] (5) Measure the total mass M2 of the test sample, water, and weighing bottle after leaving it for 24 hours.

[0062] (6) Calculate the moisture permeability P1 according to the following formula (2).

[0063] Moisture permeability P1 = (total mass M1 - total mass M2) / specified area S (2)

[0064] The hardness (strength) of the cover part 11 can be appropriately designed to any size, for example, it can be 10 to 40. If the hardness of the cover part 11 is within the above-mentioned preferred range, when the skin 2 is stretched due to body movement, the upper sheet 12, the electrode 20 and the second layer part 40 can easily deform in accordance with the movement of the skin 2 without being affected by the cover part 11. It should be noted that hardness refers to Shore A hardness. In this specification, Shore A hardness refers to the hardness measured based on ISO7619 (JISK6253). Shore A hardness can be measured using an ordinary Shore A durometer.

[0065] (Upper piece)

[0066] like Figure 3As shown, 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 opposite the protrusion 111 of the cover member 11. Through the through-hole 12a, the sensor body 32 of the sensor unit 30 is not blocked by the upper sheet 12 but is accommodated in the accommodation space S formed by the recess 111a on the inner surface of the cover member 11 and the through-hole 12a.

[0067] The upper sheet 12 is formed to have an extension portion 12A that protrudes outward from the cover member 11 in a plan view, and has a shape that is larger outward than the cover member 11. In other words, the extension portion 12A is the outer peripheral portion of the first base material 121 that is not covered by the cover member 11, and protrudes beyond the outer peripheral portion of the cover member 11 when the cover member 11 is attached.

[0068] The amount (protrusion length) by which the extension portion 12A protrudes from the outer periphery of the upper sheet 12 can be any appropriate value, for example, several millimeters, preferably 3 mm to 10 mm, and more preferably 5 mm to 7 mm. It should be noted that the extension portion 12A can be set to the length of the extension from the outer periphery of the cover member 11. Furthermore, if the outer periphery of the cover member 11 is partially concave or protruding when viewed from above, the extension portion 12A can be set to the shortest possible distance.

[0069] The upper sheet 12 has: a first substrate 121; a first adhesive layer 122, which is arranged on a surface of the first substrate 121 opposite to the electrode 20, and the electrode 20 is attached to the first adhesive layer 122; and an upper adhesive layer 123, which is arranged on the surface (upper surface) of the first substrate 121 opposite to the surface on the second layer component 40 side, wherein the surface of the first substrate 121 on the second layer component 40 side is a surface of the first substrate 121 opposite to the electrode 20.

[0070] The extension portion 12A can be composed of two layers: the extension portion 121A of the first base material 121 that constitutes the upper sheet 12, and the extension portion 122A of the first adhesive layer 122. It should be noted that the extension portion 12A only needs to include the extension portion 121A of the first base material 121. For example, the extension portion 12A may include only the extension portion 121A. Alternatively, the extension portion 12A may be composed of three layers: the extension portion 121A, the extension portion 122A, and the extension portion of the upper adhesive layer 123. It should be noted that, to prevent adhesion to clothing or the like, or the accumulation of dust, the extension portion 12A preferably does not include an extension portion in the upper adhesive layer 123.

[0071] ((First Base Material))

[0072] like Figure 3 As shown, the first substrate 121 is provided on the opening side of the cover member 11, that is, the attachment side. Figure 1As shown, the first substrate 121 is formed into a sheet. The first substrate 121 can be flexible, waterproof, and breathable. Because the first substrate 121 is flexible, waterproof, and breathable, it easily stretches when in contact with the skin 2, maintaining contact with the skin 2 and preventing liquid from entering the gap between the first substrate 121 and the upper adhesive layer 123. Furthermore, water vapor generated by perspiration from the skin 2 can be released to the outside of the biosensor 1 through the first substrate 121. Consequently, the upper sheet 12 easily maintains adhesive durability.

[0073] The first substrate 121 may be a non-porous material or a porous material, as long as it is flexible, waterproof, and moisture-permeable. A non-porous material is preferred because it facilitates maintaining the thinness and strength of the first substrate 121. A porous material is also preferred because it facilitates the release of water vapor generated by sweat and the like from the skin 2 to which the biosensor 1 is applied, through the first substrate 121, to the exterior of the biosensor 1.

[0074] As the non-porous body, a molded body formed into a sheet shape can be used.

[0075] As porous body, can have the bubble structure such as continuous bubble, independent bubble, semi-independent bubble.That is, porous body can be the porous body (porous body with connected bubble structure) manufactured by the foam molding forming connected bubble, can also be the porous body (porous body with independent bubble structure) manufactured by the foam molding forming independent bubble, can also be the porous body (porous body with independent bubble structure) manufactured by the foam molding forming semi-independent bubble.Wherein, from the viewpoint of giving play to higher waterproofness and seeking to maintain filmization and intensity simultaneously, the porous body with independent bubble structure is preferred.As porous body, for example, can use foam sheet, nonwoven sheet etc.

[0076] As a material forming the first base material 121, for example, a flexible material such as a thermoplastic resin such as polyurethane resin, polystyrene resin, polyolefin resin, silicone resin, acrylic resin, polyvinyl chloride resin, or polyester resin, or a thermoplastic elastomer can be used.

[0077] 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.

[0078] When the first base material 121 is a non-porous body, specifically, a polyurethane sheet such as "Esmer URS" manufactured by Matai Co., Ltd. of Japan can be used.

[0079] When the first base material 121 is a porous body, specifically, a foam sheet such as "FOLEC" manufactured by INOAC, or a non-woven fabric sheet such as the medicinal patch fabric EW manufactured by Nippon Vilene can be used.

[0080] The first base material 121 has an extension 121A. The extension 121A may protrude from the outer periphery of the cover member 11 and the second layer member 40 in the longitudinal and width directions of the outer periphery of the first base material 121. It should be noted that the extension 121A may also protrude from the outer periphery of the first base material 121 in the longitudinal or width directions.

[0081] The first base material 121 is moisture-permeable, so water vapor generated by sweat or the like can be efficiently released from the extension portion 121A, thereby preventing moisture such as sweat from accumulating between the first base material 121 and the skin 2. This can suppress skin inflammation and prevent the extension portion 121A from peeling.

[0082] The first base material 121 may be set to have higher elasticity than the cover member 11 .

[0083] Although the moisture permeability of the first base material 121 may be higher than that of the cover member 11, the moisture permeability of the first base material 121 is 3600 g / (m 2 ·day) or less, preferably 3500g / (m 2 ·day) or less, more preferably 2000g / (m 2 The lower limit of the moisture permeability of the first substrate 121 is 100 g / (m 2 As long as the moisture permeability of the first substrate 121 is 3600g / (m 2 ·day) or less, it is possible to suppress the intrusion of water vapor from the outside.

[0084] It should be noted that the method for calculating the moisture permeability of the first base material 121 is not particularly limited, and a general method may be used, or the same method as that for measuring the moisture permeability of the cover member 11 may be used.

[0085] The thickness of the first substrate 121 can be appropriately set depending on the type of the first substrate 121, but is preferably thicker than the thickness of the outer periphery of the cover member 11. If the first substrate 121 is thicker than the outer periphery of the cover member 11, irritation caused by the outer periphery of the cover member 11 contacting the skin 2 can be reduced. The thickness of the first substrate 121 is preferably 10 μm to 1.5 mm, and more preferably 0.7 mm to 1.0 mm, for example.

[0086] When the first substrate 121 is formed of a porous material such as a foam sheet or a non-woven fabric sheet, the thickness of the first substrate 121 is preferably 0.5 mm to 1.5 mm, and more preferably 1.0 mm to 1.3 mm, for example.

[0087] When the first base material 121 is formed of a non-porous body 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 30 μm to 200 μm.

[0088] like Figure 3 As shown, first base material 121 has through-hole 121a at a position facing protrusion 111 of cover member 11. Since first adhesive layer 122 and upper adhesive layer 123 are provided on the surface of first base material 121 other than through-hole 121a, through-holes 122a and 123a may also be formed in first adhesive layer 122 and upper adhesive layer 123. Through-holes 121a, 122a, and 123a form through-hole 12a.

[0089] ((First Adhesive Layer))

[0090] like Figure 3 As shown, the first adhesive layer 122 is provided in a state of being attached to a surface of the first substrate 121 opposite to the electrode 20. The first adhesive layer 122 is located on the surface of the first substrate 121 on the biological side (-Z axis direction) and has the functions of adhering the skin 2 to the first substrate 121, adhering the first substrate 121 to the second substrate 41, and adhering the first substrate 121 to the electrode 20.

[0091] The first adhesive layer 122 can have moisture permeability. As described below, water vapor generated by sweat or the like from the skin 2 to which the biosensor 1 is attached can be released through the first adhesive layer 122 into the first base material 121 and released from the first base material 121 to the exterior of the biosensor 1. When the first base material 121 has a bubble structure as described above, water vapor can be released through the first adhesive layer 122 to the exterior of the biosensor 1. 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. Consequently, it is possible to prevent moisture accumulated at the interface between the skin 2 and the first adhesive layer 122 from weakening the adhesive force of the first adhesive layer 122 and causing the biosensor 1 to peel from the skin 2.

[0092] The moisture permeability of the first adhesive layer 122 is preferably 1 g / (m 2 The moisture permeability of the first adhesive layer 122 may be 10000 g / (m 2 If the moisture permeability of the first adhesive layer 122 is 1g / (m 2 ·day) or more, when the first adhesive layer 122 is attached to the skin 2, sweat and the like transmitted from the first adhesive layer 122 can pass through to the outside, thereby reducing the burden on the skin 2.

[0093] As the material forming the first adhesive layer 122, a material having pressure-sensitive adhesive properties can be used. Examples of the material having pressure-sensitive adhesive properties include acrylic adhesives and silicone adhesives, with acrylic adhesives being preferred. Examples of acrylic adhesives include propylene polymers described in Japanese Patent Application Laid-Open No. 2002-65841.

[0094] The first adhesive layer 122 may be a double-sided adhesive tape formed of the above-mentioned materials.

[0095] The first adhesive layer 122 may also have a wavy pattern (web pattern) formed on its surface, with adhesive-containing areas alternating with non-adhesive areas where the adhesive is absent. For example, a double-sided adhesive tape with a web pattern formed on its surface may be used as the first adhesive layer 122. The web pattern on the surface of the first adhesive layer 122 allows adhesive to adhere to the convex portions of the surface and their surrounding areas, while not adhering to the concave portions of the surface and their surrounding areas. Therefore, since the surface of the first adhesive layer 122 has both areas where the adhesive is present and areas where it is absent, the adhesive can be distributed across the surface of the first adhesive layer 122. The thinner the adhesive, the more likely it is to improve the moisture permeability of the first adhesive layer 122. Therefore, by forming a web pattern on the surface of the first adhesive layer 122, the adhesive is partially thinner, which improves moisture permeability while maintaining adhesion compared to a case without a web pattern.

[0096] The widths of the adhesive portion and the non-adhesive portion can be appropriately designed. For example, the width of the adhesive 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 portion and the non-adhesive portion are respectively within the above-mentioned preferred ranges, the first adhesive layer 122 can maintain adhesion while exhibiting excellent moisture permeability.

[0097] The thickness of the first adhesive layer 122 can be appropriately set, and can be, for example, 10 μm to 300 μm. If the thickness of the first adhesive layer 122 is 10 μm to 300 μm, the biosensor 1 can be made thinner.

[0098] The first adhesive layer 122 has an overhanging portion 122A. Because the overhanging portion 122A protrudes beyond the outer periphery of the cover member 11, the area of ​​adhesion to the skin 2 can be increased compared to a case where the upper sheet 12 is formed to the same size as the cover member 11. This improves the adhesion of the biosensor 1 to the skin 2.

[0099] Furthermore, when the biosensor 1 is attached to the skin 2 and the skin 2 deforms due to, for example, the subject's body movements, the biosensor 1 deforms along with the deformation of the skin 2. In this case, because the extension 121A is positioned so as to protrude beyond the outer periphery of the cover member 11, direct contact with the skin by the outer periphery of the cover member 11 is prevented when the skin 2 deforms. Consequently, irritation of the skin 2 by the outer periphery of the cover member 11 is suppressed, thereby minimizing the occurrence of pain or itching on the skin 2.

[0100] When skin 2 stretches due to body movement, the outer periphery of top sheet 12 stretches in response to the stretching of skin 2. At this time, the stress applied to cover member 11 is reduced by deformation of first adhesive layer 122 of top sheet 12 and the deformation of top sheet 12, thereby suppressing deformation of top adhesive layer 123. In other words, extension 12A of top sheet 12 functions as a cushioning material that absorbs the stretching of skin 2, and some of the stretching of skin 2 is absorbed by extension 12A.

[0101] This reduces the stretching of the outer periphery of the cover member 11 caused by the stretching of the skin 2. This prevents the skin 2 from being pulled in a contracting direction by the reaction force of the outer periphery of the cover member 11 caused by the stretching of the skin 2, thereby suppressing the occurrence of pain or itching caused by body movement of the outer periphery of the skin 2 to which the biosensor 1 is attached. As a result, the wearing comfort of the subject can be improved when the biosensor 1 is attached to the skin 2.

[0102] Furthermore, compared to a case where the upper sheet 12 is formed to have the same dimensions as the cover member 11, the contact area between the first adhesive layer 122 of the upper sheet 12 and the skin 2 can be increased. Consequently, the adhesive force of the first adhesive layer 122 can be weaker than when the upper sheet 12 is formed to have the same dimensions as the cover member 11. Since the adhesive force per unit area of ​​the first adhesive layer 122 can be reduced, the biosensor 1 can be easily peeled from the skin 2 without reducing the adhesion between the biosensor 1 and the skin 2. For example, the biosensor 1 can be peeled from the skin 2 without using tools such as removers, and without causing pain to the subject.

[0103] It should be noted that, in this embodiment, the extension portion 12A protrudes beyond the entire surface of the outer periphery of the cover member 11. However, a portion of the extension portion 12A may protrude beyond the outer periphery of the cover member 11. In other words, the extension portion 12A may be provided only at a location where the biosensor 1 is easily separated from the skin 2 due to body movement or the like.

[0104] For example, when the biosensor 1 is attached to the living body P so that the flat portion 112A side of the cover member 11 is located on the ventral side of the living body P (see Figure 4 ), the ventral side is more likely to be displaced by body movements than the flat portion 112B side, and the biosensor 1 is more likely to be peeled off than the flat portion 112B side. Therefore, it is preferable to provide the extension 12A at least at the end of the cover member 11 on the flat portion 112A side.

[0105] Furthermore, the ends of the biosensor 1 in the longitudinal direction (Y-axis direction) are more likely to be displaced by body movements than the ends in the width direction (X-axis direction), making them more susceptible to peeling. Therefore, it is preferable to provide the extensions 12A only at the two ends of the biosensor 1 in the longitudinal direction (Y-axis direction).

[0106] By providing the extension 12A at a portion of the biosensor 1 that is susceptible to peeling, as described above, when the skin 2 deforms due to body movement, the extension 12A can disperse the pressing force applied to the skin by the cover member 11 in the upper sheet 12. Thus, peeling of the biosensor 1 can be suppressed by the reaction force from the skin to the pressing force applied by the cover member 11 to the extension 12A.

[0107] ((Upper adhesive layer))

[0108] like Figure 3 As shown, the upper adhesive layer 123 is provided to adhere to the surface (upper surface) of the first substrate 121 opposite to the surface facing the electrode 20. The upper adhesive layer 123 is adhered to a position on the upper surface of the first substrate 121 corresponding to the flat surface on the adhesion side (-Z axis direction) of the cover member 11, and has the function of bonding the first substrate 121 to the cover member 11.

[0109] A biocompatible material can be used as the material forming the upper adhesive layer 123. Examples of biocompatible materials include acrylic adhesives, silicone adhesives, and silicone tapes, and silicone adhesives are preferred.

[0110] The thickness of the upper adhesive layer 123 can be appropriately set, and can be, for example, 10 μm to 300 μm.

[0111] (moisture permeable film)

[0112] like Figure 2 and Figure 3 As shown, the moisture-permeable membrane 13 can be disposed in the recess 111a of the cover member 11 so as to cover the through-hole 111b. The moisture-permeable membrane 13 can be secured to the recess 111a of the cover member 11 using an adhesive 14. The adhesive 14 can be disposed along the outer periphery of the upper surface of the moisture-permeable membrane 13. It should be noted that the adhesive 14 can be disposed only at the outer corners of the upper surface of the moisture-permeable membrane 13 or only at the outer periphery of the upper surface of the moisture-permeable membrane 13.

[0113] The moisture permeability of the moisture-permeable film 13 may be adjusted so that the second moisture permeability M2 is smaller than the first moisture permeability M1.

[0114] The thickness of the moisture-permeable film 13 is not particularly limited, and may be any appropriate thickness.

[0115] The adhesive 14 only needs to be able to fix the moisture-permeable film 13 to the cover member 11 , and may be, for example, a commonly used adhesive.

[0116] Alternatively, the moisture-permeable film 13 may be fixed to the inner wall of the through-hole 111 b using an adhesive 14 or the like, and provided so as to cover the through-hole 111 b.

[0117] The moisture-permeable film 13 may be any film as long as it has water vapor permeability. For example, a moisture-permeable sheet is used as the moisture-permeable film 13 .

[0118] [electrode]

[0119] like Figure 3 As shown, the electrode 20 can be attached to the lower surface of the first adhesive layer 122, i.e., the attachment side (-Z axis direction), in the following state: a portion of the electrode 20 on the sensor body 32 side is connected to the wiring 331A, 331B, and is simultaneously sandwiched between the first adhesive layer 122 and the lower adhesive layer 42. The portion of the electrode 20 not sandwiched between the first adhesive layer 122 and the lower adhesive layer 42 contacts the living body. When the biosensor 1 is attached to the skin 2, the electrode 20 contacts the skin 2, thereby enabling detection of biological signals. It should be noted that the electrode 20 can also be embedded in the second substrate 41 in a state where it is exposed and can contact the skin 2.

[0120] The electrode 20 includes a pair of electrodes 20A and 20B. Figure 3 As shown, electrode 20A is provided on the left side of the figure, while electrode 20B is provided on the right side of the figure. One end side (inner side) of electrode 20A along its length direction (Y-axis direction) contacts terminal portion 332A, while one end side (inner side) of electrode 20B along its length direction (Y-axis direction) contacts terminal portion 332B. The pair of electrodes 20A and 20B have substantially the same shape.

[0121] It should be noted that one end side of the electrode 20A in contact with the terminal portion 332A of the sensor portion 30 and one end side of the electrode 20B in contact with the terminal portion 332B of the sensor portion 30 are referred to as the opposing portions 201A and 201B. The portion of the electrode 20A not in contact with the terminal portion 332A and the portion of the electrode 20B not in contact with the terminal portion 332B (the other end side (outer side) in the longitudinal direction (Y-axis direction)) are referred to as the exposed portions 202A and 202B.

[0122] The electrode 20 may have any shape such as a sheet shape.

[0123] The shape of the electrode 20 when viewed from above is not particularly limited and can be appropriately designed into any shape according to the application. Figure 2As shown, in a plan view, the facing portions 201A and 201B on one end side are formed in a rectangular shape, while the exposed portions 202A and 202B on the other end side are formed in a circular shape.

[0124] 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. However, from the perspective of biological safety, for example, to prevent allergic reactions when the electrode 20 is applied to a living body, it is preferable to use a cured product of a conductive composition to form the electrode 20. The electrode 20 can be an adhesive electrode sheet having a cured product of a conductive composition formed into a sheet.

[0125] As conductive polymers, for example, polythiophene-based conductive polymers, polyaniline-based conductive polymers, polyacetylene-based conductive polymers, polypyrrole-based conductive polymers, polystyrene-based conductive polymers, derivatives thereof, and composites thereof can be used. 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 polythiophene is doped with polystyrenesulfonic acid (poly-4-styrenesulfonate; PSS) as polyaniline in poly(3,4-ethylenedioxythiophene) (also known as PEDOT), is preferred because of its low contact impedance with the organism and high conductivity.

[0126] The binder resin may be a water-soluble polymer or a water-insoluble polymer, etc. As the water-soluble polymer, a polymer containing a hydroxyl group such as polyvinyl alcohol (PVA) or modified PVA can be used.

[0127] The conductive composition may contain various common additives such as a crosslinking agent and a plasticizer in any proportion. The crosslinking agent may include an aldehyde compound such as sodium glyoxylate. Plasticizers include glycerol, ethylene glycol, propylene glycol, and the like.

[0128] As the metal and the alloy, general metals and alloys such as Au, Pt, Ag, Cu, and Al can be used.

[0129] The thickness of the electrode 20 may be any appropriate thickness, for example, 10 μm to 100 μm. If the thickness of the electrode 20 is within the above preferred range, the electrode 20 may have sufficient strength and flexibility.

[0130] It should be noted that the thickness of the electrode 20 refers to the length of the electrode 20 in a direction perpendicular to its surface. The thickness of the electrode 20 is, for example, the thickness when measured at any position on the cross section of the electrode 20. When measuring multiple positions at the same position, it may also be the average value of the thicknesses at these measured positions.

[0131] (Sensor part)

[0132] like Figure 2 As shown, the sensor section 30 includes a flexible substrate 31 , a sensor body 32 , and connection portions 33A, 33B connected to the sensor body 32 .

[0133] The flexible substrate 31 is a resin substrate on which various components for acquiring biological information are mounted, and the sensor body 32 and the connecting portions 33A and 33B are arranged on the flexible substrate 31 .

[0134] like Figure 2 As shown, the sensor body 32 includes a component mounting portion 321 as a control portion and a battery mounting portion 322 to acquire biological information.

[0135] The component mounting section 321 includes various components mounted on the flexible substrate 31, including a CPU and integrated circuit that process biological signals acquired from a living body to generate biological signal data, a switch for activating the biosensor 1, a flash memory for storing biological signals, and a light-emitting element, thereby acquiring biological information. Circuit diagrams of the various components are omitted. The component mounting section 321 operates using power supplied by the battery 34 mounted on the battery mounting section 322.

[0136] The component mounting section 321 transmits a signal to an external device such as an operation confirmation device that confirms the initial operation and a reading device that reads biological information from the biosensor 1 in a wired or wireless manner.

[0137] The battery mounting portion 322 is disposed between the connecting portion 33A and the component mounting portion 321 and supplies power to the integrated circuit and the like mounted on the component mounting portion 321. Figure 2 As shown, the battery 34 is mounted to the battery mounting portion 322 .

[0138] The connection parts 33A and 33B have wirings 331A and 331B respectively connected to the sensor body 32 in the longitudinal direction (Y-axis direction) of the sensor body 32, and terminal parts 332A and 332B provided on the front end side of the wirings 331A and 331B and connected to the electrode 20.

[0139] like Figure 3 As shown, one end of the wiring 331A, 331B is connected to the electrode 20. Figure 3 As shown, the other end of wiring 331A is connected to a switch or the like mounted on the component mounting portion 321 along the outer periphery of the sensor body 32. The other end of wiring 331B is connected to a switch or the like mounted on the component mounting portion 321. Note that wirings 331A and 331B may be formed in either the wiring layer on the front or back side of the flexible substrate 31.

[0140] The terminal portions 332A and 332B are arranged such that one end thereof is connected to the wires 331A and 331B and the upper surfaces of the other ends are in contact with the electrode 20 while being sandwiched between the first layer component 10 and the second layer component 40 .

[0141] A known battery can be used as the battery 34. For example, a coin-type battery such as CR2025 can be used as the battery 34.

[0142] [Second layer components]

[0143] like Figure 3 As shown, the second layer member 40 is attached to the surface (lower surface) on the side opposite to the protruding direction of the first layer member 10 and has an attachment surface that is attached to the skin 2. The second layer member 40 is provided on the attachment surface side of the electrodes 20 and the sensor unit 30, serves as a supporting substrate for mounting the sensor unit 30, and forms a portion of the attachment surface that is attached to the skin 2.

[0144] like Figure 1 and Figure 2 As shown, the outer shape of both sides of the width direction (X-axis direction) of the second layer component 40 can be substantially the same as the outer shape of both sides of the width direction (X-axis direction) of the first layer component 10. The length (Y-axis direction) of the second layer component 40 can be formed to be shorter than the length (Y-axis direction) of the cover component 11 and the upper sheet 12. The second layer component 40 can be arranged so that the electrode 20 is exposed on the lower surface of the first layer component 10. Figure 3 As shown, both ends of the second layer member 40 in the longitudinal direction may be positions where the wirings 331A and 331B of the sensor unit 30 are sandwiched between the second layer member 40 and the upper sheet 12 and overlap with a portion of the electrode 20 .

[0145] The second layer component 40 includes a second base material 41, a lower adhesive layer 42 provided on the upper surface of the second base material 41, and a second adhesive layer 43 provided on the lower surface of the second base material 41. The second base material 41, the lower adhesive layer 42, and the second adhesive layer 43 can be formed to have the same shape when viewed from above. The second adhesive layer 43 of the second layer component 40 and the electrodes 20 form the surface for attaching to the skin 2. The waterproofness and moisture permeability vary depending on the area of ​​the electrodes 20 and the second adhesive layer 43, and depending on the position of the attachment surface, allowing for different adhesive properties. Therefore, it is possible to vary the waterproofness and moisture permeability, as well as the adhesiveness, depending on the area of ​​the attachment surface of the second adhesive layer 43.

[0146] (Second Base Material)

[0147] The second substrate 41 can be formed using a flexible resin having appropriate stretchability, flexibility, and toughness. Examples of materials for forming the second substrate 41 include polyester resins such as polyethylene terephthalate (PET), polybutylene terephthalate, polyethylene terephthalate, polyethylene naphthalate, and polybutylene naphthalate; acrylic resins such as polyacrylic acid, polymethacrylic acid, polymethyl acrylate, polymethyl methacrylate (PMMA), polyethyl methacrylate, and polybutyl acrylate; polyolefin resins such as polyethylene and polypropylene; polystyrene resins such as polystyrene, imide-modified polystyrene, acrylonitrile-butadiene-styrene (ABS) resin, imide-modified ABS resin, styrene-acrylonitrile copolymer (SAN) resin, and acrylonitrile-ethylene-propylene-diene-styrene (AES) resin; polyimide resins; polyurethane resins; silicone resins; and thermoplastic resins such as polyvinyl chloride 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 water-resistant (low in moisture permeability), impermeable to water and water vapor. Therefore, using these thermoplastic resins to form the second substrate 41 prevents sweat or water vapor generated from the skin 2 of a living being from invading the flexible substrate 31 side of the sensor unit 30 through the second substrate 41 when the biosensor 1 is attached to the skin 2 of the living being.

[0148] Since the sensor portion 30 is provided on the upper surface side of the second base material 41 via the lower adhesive layer 42 , the second base material 41 is preferably formed in a flat plate shape.

[0149] The thickness of the second base material 41 can be arbitrarily selected as appropriate, and may be, for example, 1 μm to 300 μm.

[0150] (Adhesive layer at the bottom)

[0151] like Figure 3 As shown, 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 adheres the sensor portion 30. The longitudinal ends of the lower adhesive layer 42 of the second layer member 40 are provided at positions opposite to the opposing portions 201A and 201B of the electrode 20. This allows the opposing portions 201A and 201B of the electrode 20 and the terminal portions 332A and 332B to be sandwiched between the upper sheet 12 and the second layer member 40 while being pressed, thereby enabling electrical conduction between the electrode 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 later, and therefore its details are omitted. It should be noted that the lower adhesive layer 42 is not necessarily required and may not be provided.

[0152] (Second Adhesive Layer)

[0153] like Figure 3 As shown, 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 in contact with the skin 2 .

[0154] The second adhesive layer 43 preferably has pressure-sensitive adhesive properties. Since the second adhesive layer 43 has pressure-sensitive adhesive properties, the biosensor 1 can be easily adhered to the skin 2 of a living being by pressing the biosensor 1 against the skin 2 of the living being.

[0155] The material of the second adhesive layer 43 is not particularly limited, as long as it is a material having pressure-sensitive adhesive properties, and can be, for example, a biocompatible material. The material forming the second adhesive layer 43 can be an acrylic pressure-sensitive adhesive, a silicone pressure-sensitive adhesive, or the like. Acrylic pressure-sensitive adhesives are preferred.

[0156] 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 (mono)acrylate such as isononyl acrylate or methoxyethyl acrylate as a main component and a monomer copolymerizable with a (mono)acrylate such as acrylic acid as an optional component can be used.

[0157] The acrylic pressure-sensitive adhesive preferably further contains a carboxylate. The carboxylate acts as a pressure-sensitive adhesive modifier, reducing the pressure-sensitive adhesiveness of the acrylic polymer and adjusting the pressure-sensitive adhesiveness of the second adhesive layer 43. The carboxylate can be any carboxylate compatible with the acrylic polymer. Triglycerides and the like can be used as the carboxylate.

[0158] The acrylic pressure-sensitive adhesive may also contain a cross-linking agent as needed. The cross-linking agent is a cross-linking component of a cross-linked acrylic polymer. Examples of the cross-linking agent include polyisocyanate compounds (multifunctional isocyanate compounds), epoxy compounds, melamine compounds, peroxide compounds, urea compounds, metal alcoholates, metal chelates, metal salt compounds, carbodiimide compounds, oxazoline compounds, azido compounds, and amine compounds. Among them, polyisocyanate compounds are preferred. These cross-linking agents may be used alone or in combination.

[0159] The second adhesive layer 43 may be a double-sided adhesive tape formed of the above-mentioned materials.

[0160] The second adhesive layer 43 preferably has excellent biocompatibility. For example, when the second adhesive layer 43 is subjected to a keratin peeling test, the keratin peeling area ratio is preferably 0% to 50%. When the keratin peeling area ratio is within the range of 0% to 50%, the burden on the skin 2 can be minimized even when the second adhesive layer 43 is applied to the skin 2.

[0161] The second adhesive layer 43 preferably has moisture permeability. Water vapor and the like generated from the skin 2 to which the biosensor 1 is attached can be released through the second adhesive layer 43 to the upper sheet 12. Furthermore, because the upper sheet 12 has the aforementioned bubble structure, water vapor can be released through the second adhesive layer 43 to the outside of the biosensor 1. This prevents sweat and water vapor from accumulating at the interface between the skin 2 to which the biosensor 1 is attached and the second adhesive layer 43. Consequently, it is possible to prevent moisture accumulated at the interface between the skin 2 and the second adhesive layer 43 from weakening the adhesive strength of the second adhesive layer 43 and causing the biosensor 1 to peel from the skin.

[0162] The moisture permeability of the second adhesive layer 43 is preferably 300 g / (m 2 ·day)~10000g / (m 2 As long as the moisture permeability of the second adhesive layer 43 is within the preferred range described above, even when the second adhesive layer 43 is adhered to the skin 2, sweat generated from the skin 2 or water vapor generated by the sweat can be appropriately transmitted through the second adhesive layer 43 to the outside, thereby reducing the burden on the skin 2.

[0163] The method for measuring the moisture permeability of the second adhesive layer 43 is not particularly limited, and a general measurement method can be used.

[0164] For example, the moisture permeability of the second adhesive layer can be measured according to the following procedure.

[0165] 1. Sample Preparation

[0166] Prepare the following samples.

[0167] (1) PET processed product: An opening with a diameter of 20 mm is formed in the center of a PET sheet measuring 50 mm in length and 50 mm in width.

[0168] (2) Double-sided tape processed product: A double-sided tape (No. 5000NS, manufactured by Nitto Denko Corporation) was attached to the separator and processed into a ring shape having a diameter of 30 mm and a hole of 20 mm in diameter at the center.

[0169] (3) Sample processing: Use a roller to attach the transfer paper tape to the upper surface of the sample sheet and process it into a disc shape with a diameter of 30 mm.

[0170] 2. Determination of moisture permeability

[0171] (1) Pour 10 mL of water (ion-exchanged water) into a moisture permeability cup (opening diameter: 38 mm, height: 40 mm).

[0172] (2) Overlap the opening of the PET product with the hole of the double-sided tape product, and attach the double-sided tape product to the PET product so that there is no gap between the PET product and the double-sided tape product, thereby producing product 1.

[0173] (3) The sample product is attached to the double-sided tape product of product 1 so that there is no gap between the double-sided tape product and the sample product, thereby producing product 2.

[0174] (4) Place workpiece 2 on the moisture permeability cup so that the center of workpiece 2 and the center of the moisture permeability cup coincide. Then, wrap vinyl tape (adhesive tape) around the end of workpiece 2 and the side of the moisture permeability cup, secure the end of workpiece 2 to the side of the moisture permeability cup, and seal the moisture permeability cup to produce workpiece 3.

[0175] (5) Measure the mass M1 of the processed product 3 (the total mass of the PET processed product, the double-sided tape processed product, the sample processed product, the vinyl tape, the moisture permeability cup, and water).

[0176] (6) The processed product 3 is placed in a thermostatic chamber and left at 40°C and 30% RH for 24 hours.

[0177] (7) After standing for 24 hours, the processed product 3 is taken out from the thermostatic bath, and the mass M2 of the processed product 3 after standing for 24 hours is measured.

[0178] (8) Calculate the evaporation amount after standing for 24 hours according to the following formula (3) and use it as the moisture permeability P2.

[0179] Moisture permeability P2[g]=(mass M2-mass M1)(3)

[0180] The thickness of the second adhesive layer 43 can be arbitrarily selected as appropriate, but 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.

[0181] like Figure 1 and Figure 2 As shown, when the biosensor 1 is not in use, a release liner 5 is preferably attached to the surface of the electrodes 20 and second substrate 41 that is to be attached to the skin 2 to protect the electrodes 20 and second layer member 40 until use. During use, the release liner 50 is peeled off from the electrodes 20 and second layer member 40, and the attachment surface of the biosensor 1 is attached to the skin 2. By pre-attaching the release liner 50 to the attachment surface, the adhesion between the electrodes 20 and second layer member 40 can be maintained even when the biosensor 1 is stored for a long period of time. Therefore, when in use, the release liner 50 is peeled off from the second layer member 40 and electrode 20, allowing the attachment surface to be securely attached to the skin 2.

[0182] The method for manufacturing the biosensor 1 is not particularly limited, and any appropriate method may be used. An example of a method for manufacturing the biosensor 1 will be described.

[0183] Prepare Figure 1 and Figure 2 The first layer member 10, the electrode 20, the sensor portion 30, and the second layer member 40 are shown. The first layer member 10, the electrode 20, the sensor portion 30, and the second layer member 40 are not particularly limited and can be manufactured using any appropriate manufacturing method as long as they can be manufactured.

[0184] Ready to pose Figure 1 After the first layer component 10, electrode 20, sensor portion 30 and second layer component 40 of the biosensor 1 shown in the figure are arranged, the sensor portion 30 is placed on the second layer component 40. Then, the first layer component 10, electrode 20, sensor portion 30 and second layer component 40 are stacked in order from the first layer component 10 side to the second layer component 40 side. Figure 1 The biosensor 1 is shown.

[0185] Figure 4 It shows Figure 1 The figure is an explanatory diagram of the state where the biosensor 1 is attached to the chest of the subject P. Figure 4 As shown, for example, the biosensor 1 is attached to the skin of the subject P in such a manner that its longitudinal direction (Y-axis direction) is aligned with the sternum of the subject P, one electrode 2 is on the upper side, and the other electrode 20 is on the lower side. Figure 2 The second adhesive layer 43 is attached to the skin of the subject P. With the electrodes 20 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 nonvolatile memory such as a flash memory mounted on the component mounting portion 321.

[0186] Thus, the biosensor 1 includes the first layer member 10, the sensor portion 30, the second layer member 40, and the storage space S, and is configured such that a first moisture permeability M1 is smaller than a second moisture permeability M2. The first moisture permeability M1 is the moisture permeability of water vapor entering the storage space S via the second layer member 40 at a first temperature, while the second moisture permeability M2 is the moisture permeability of water vapor discharged from the storage space S via the first layer member 10 at a second temperature T2.

[0187] The second layer member 40 is in contact with the skin 2, while the first layer member 10 is in contact with the outside. During use of the biosensor 1, the second layer member 40 is heated to, for example, approximately 36°C, close to body temperature, while the first layer member 10 is cooled to, for example, approximately 30°C, below body temperature. Consequently, the skin 2 side, which is at a higher temperature, is at a temperature that allows water vapor to pass more easily, while the cover member 11 side, which is at a lower temperature, is at a temperature that makes it more difficult for moisture to pass through.

[0188] When the amount of water vapor entering the storage space S from the skin 2 via the second layer member 40 is equal to or greater than the amount of water vapor exhausted from the storage space S via the first layer member 10, the amount of water vapor within the storage space S tends to increase. Consequently, the water vapor adheres to the sensor body 32 of the sensor section 30 within the storage space S, causing condensation to form. For example, as the skin 2 side becomes warmer and the outside becomes colder, the movement of water vapor from the second layer member 40, which is in direct contact with the skin 2, into the storage space S becomes more active, while the amount of water vapor exhausted from the storage space S via the first layer member 10 becomes smaller. Consequently, the water vapor accumulates within the storage space S, forming water droplets that tend to form condensation on the sensor body 32.

[0189] By making the first moisture permeability M1 smaller than the second moisture permeability M2, the biosensor 1 suppresses water vapor generated by sweat produced by the skin 2 from being retained in the storage space S through the second layer member 40, thereby facilitating the discharge of the water vapor from the storage space S to the outside through the first layer member 10. Consequently, the biosensor 1 can reduce condensation on the sensor body 32.

[0190] By reducing condensation on the sensor main body 32 , the biosensor 1 can suppress malfunction of the sensor main body 32 and stably measure a biosignal.

[0191] Furthermore, even when the biosensor 1 is attached to the subject's skin 2 for a long period of time, it is possible to suppress the accumulation of water vapor between the skin 2 and the attachment surface of the biosensor 1. Consequently, the biosensor 1 can reduce discomfort, such as itching or pain, caused by water vapor generated by sweat or the like accumulating between the skin 2 and the attachment surface of the biosensor 1, thereby maintaining a good sense of attachment.

[0192] In the biosensor 1, the first layer member 10 can include the cover member 11 and the upper sheet 12, and the upper sheet 12 can include the first base material 121. The first layer member 10 can be formed by laminating the cover member 11 and the first base material 121. Therefore, even if the first layer member 10 is composed of multiple other members, the biosensor 1 can form a storage space S surrounding the sensor body 32 in the first layer member 10 while facilitating the release of water vapor generated by sweat from the skin 2 from the storage space S to the outside through the first layer member 10, thereby reducing condensation on the sensor body 32.

[0193] The biosensor 1 can include a through-hole 111b in the cover member 11 of the first layer member 10, and can include a moisture-permeable film 13 covering the through-hole 111b. This increases the moisture permeability of the cover member 11, thereby allowing water vapor that has passed from the second layer member 40 into the storage space S to be easily released from the outside of the cover member 11. Consequently, the biosensor 1 can more easily maintain the first moisture permeability M1 smaller than the second moisture permeability M2, further reducing condensation on the sensor body 32.

[0194] The biosensor 1 can include a second adhesive layer 43 on the surface of the second layer component 40 opposite the first layer component 10. This allows the biosensor 1 to adhere the second layer component 40 to the skin 2 via the second adhesive layer 43, thereby further reducing the contact impedance between the electrode 20 and the surface of the skin 2, further suppressing noise generation, and achieving more stable adhesion to the skin 2. Consequently, during use, the biosensor 1 can further improve the accuracy of biosignal detection and maintain more stable adhesion to the skin 2.

[0195] The biosensor 1 may include electrodes 20 on the second layer 40 side of the first layer 10 to connect to the sensor body 32. This allows the electrodes 20 to contact the surface of the skin 2, thereby detecting a biosignal via the electrodes 20 during use.

[0196] The biosensor 1 can include the electrode 20 on the surface of the first layer member 10 facing the second layer member 40, and the first adhesive layer 122 on the surface of the first base member 121 facing the second layer member 40. Because the first adhesive layer 122 has adhesive properties, the electrode 20 can contact the surface of the skin 2 while being stably adhered to the first layer member 10 via the first adhesive layer 122. Therefore, in the biosensor 1, when the electrode 20 contacts the surface of the skin 2 and detects a biosignal via the electrode 20, the contact impedance between the electrode 20 and the surface of the skin 2 can be reduced, suppressing the generation of noise and enabling more stable adhesion to the skin 2. Consequently, during use, the biosensor 1 can improve the accuracy of the electrode 20 in detecting biosignals while maintaining stable adhesion to the skin 2.

[0197] The biosensor 1 can be provided with a second layer member 40 so that the electrodes 20 are exposed on the surface of the first base member 121 that faces the cover member 11. Thus, when the biosensor 1 detects a biosignal via the electrodes 20, the electrodes 20 can be brought into contact with the surface of the skin 2, thereby enabling reliable detection of the biosignal during use.

[0198] The biosensor 1 can be provided with an extension 12A on the upper sheet 12. The extension 12A can include an extension 121A on the first base material 121 and an extension 122A on the first adhesive layer 122. This allows the first adhesive layer 122 to expand its adhesion area to the skin 2, thereby preventing the biosensor 1 from peeling off the skin 2. Consequently, compared to a case where the first base material 121 and the upper sheet 12 are formed to the same dimensions as the cover member 11, the biosensor 1 can be stably attached to the skin 2 for a longer period of time. Consequently, the biosensor 1 can extend the time it takes to measure biological information.

[0199] Furthermore, by providing the extension 12A in the upper sheet 12, the biosensor 1 can prevent the outer peripheral edge of the cover member 11 from directly contacting the skin 2 when the skin 2 deforms due to body movement, thereby reducing irritation (and the occurrence of pain) to the skin 2 caused by the outer periphery of the cover member 11. In particular, when the first base material 121 has high flexibility, even when the outer peripheral edge of the cover member 11 is directed toward the skin 2 due to deformation of the skin 2, the biosensor 1 can distribute the pressing force exerted by the outer periphery of the cover member 11 on the skin 2 within the upper sheet 12, thereby reducing irritation to the skin 2.

[0200] Because the extension 121A functions as a cushioning material that absorbs the stretching of the skin 2, it is possible to suppress the reaction force of the outer periphery of the cover member 11 from stretching the skin 2, which would otherwise pull the skin 2 in the contraction direction. Therefore, the biosensor 1 can suppress pain caused by body movement on the skin 2 attached to its outer periphery, thereby improving the wearing comfort of the biosensor 1.

[0201] Because the extension 121A distributes the pressing force exerted by the cover member 11 on the skin 2 when the skin 2 deforms due to body movement within the upper sheet 12, it is possible to suppress the biosensor 1 from peeling off due to the reaction force of the skin 2 against the pressing force of the cover member 11. As a result, the biosensor 1 is less likely to peel off from the skin 2, and a decrease in the adhesion of the upper sheet 12 to the first adhesive layer 122 can be suppressed. Consequently, the biosensor 1 can reduce irritation of the skin 2 by the first adhesive layer 122.

[0202] Since the extension portion 12A includes the extension portion 122A of the first adhesive layer 122, the contact area between the first adhesive layer 122 and the skin 2 can be increased. Therefore, even if the adhesive force of the first adhesive layer 122 weakens, the biosensor 1 can still be attached to the skin 2, thus causing no pain to the living subject P and allowing for easy removal from the skin 2 after use.

[0203] The biosensor 1 can include an upper adhesive layer 123 on the upper surface of the first base material 121. Since the cover member 11 and the first base material 121 can be bonded via the upper adhesive layer 123, the first layer member 10 can form a storage space S surrounding the sensor body 32 while preventing separation between the cover member 11 and the first base material 121. Therefore, even if the first layer member 10 is composed of multiple other components, the biosensor 1 can form the storage space S while preventing gaps from forming between the components that comprise the first layer member 10. Furthermore, water vapor generated by sweat from the skin 2 can be easily discharged from the storage space S to the outside through the first layer member 10, thereby reducing condensation on the sensor body 32.

[0204] The biosensor 1 can use a polyurethane-based thermoplastic elastomer to form the first substrate 121. Using a polyurethane-based thermoplastic elastomer to form the first substrate 121 allows for easy control of the moisture permeability and adhesion to the skin 2 by adjusting the thickness of the first substrate 121 to any desired thickness. Therefore, even if the surface of the skin 2 deforms due to body movement, the biosensor 1 can maintain stable and easy adhesion to the skin 2.

[0205] Biosensor 1 can form an adhesive surface for skin 2 using first layer 10, electrodes 20, and second layer 40. This allows for a reduced thickness of biosensor 1. Consequently, biosensor 1 is smaller in size, reduces contact resistance with the surface of skin 2, and maintains stable adhesion to skin 2.

[0206] As described above, the biosensor 1 can stably measure biological information from the skin 2 over a long period of time during use, and therefore can be effectively used as an adhesive-type biosensor that is attached to a person's skin 2. For example, the biosensor 1 can be attached to the skin of a living being and is suitable for use in wearable healthcare devices that require high electrocardiogram (ECG) detection sensitivity and high noise suppression.

[0207] As described above, the embodiments have been described. However, the embodiments are provided as examples and do not limit the present invention. The embodiments described above can be implemented in various other ways, and various combinations, omissions, substitutions, and modifications can be made without departing from the spirit of the invention. These embodiments and their variations are included in the scope and spirit of the invention and are included in the scope of the invention described in the claims.

[0208] It should be noted that the embodiments of the present invention are as follows, for example.

[0209] <1> A biosensor is a biosensor attached to a living body, comprising:

[0210] A sensor body for acquiring biological information;

[0211] a first layer member having a shape protruding so as to cover the sensor body;

[0212] a second layer member attached to a surface of the first layer member on a side opposite to the protruding direction and having an attachment surface for attachment to the living body; and

[0213] a receiving space, enclosed by the first layer component and the second layer component, for receiving the sensor body;

[0214] A moisture permeability of water vapor entering the storage space through the second layer component at a first temperature is smaller than a moisture permeability of water vapor discharged from the storage space through the first layer component at a second temperature, wherein the second temperature is lower than the first temperature.

[0215] <2> according to <1> The biosensor, wherein

[0216] The first layer of components includes:

[0217] a cover member having at least a portion of the storage space; and

[0218] The base material is provided on the second layer member side of the cover member.

[0219] <3> according to <2> The biosensor comprises:

[0220] a through hole communicating with the storage space of the cover member; and

[0221] The moisture-permeable membrane is arranged in the through hole.

[0222] <4> according to <1> to <3> The biosensor according to any one of the preceding claims, wherein the second layer member has an adhesive layer on a surface opposite to the first layer member.

[0223] <5> according to <1> to <4> The biosensor according to any one of the preceding claims, wherein an electrode connected to the sensor body is provided on a surface of the first layer member on the second layer member side.

[0224] <6> according to <2> to <5> The biosensor according to any one of the preceding claims, wherein:

[0225] An electrode connected to the sensor body is provided on a surface of the first layer component on the second layer component side.

[0226] The first layer member has an adhesive layer on a surface of the substrate on the second layer member side, and the electrode is attached to the adhesive layer.

[0227] <7> according to <5> or <6> The biosensor according to any one of the preceding claims, wherein the second layer member is provided so that the electrode is exposed on a lower surface of the first layer member.

[0228] <8> according to <2> to <7> The biosensor according to any one of the preceding claims, wherein the base material has a protruding portion on at least a portion of an outer periphery thereof, the protruding portion protruding beyond an outer periphery of at least one of the cover member and the second layer member.

[0229] <9> according to <2> to <8> The biosensor according to any one of the preceding claims, wherein the first layer member has an adhesive layer on a surface of the substrate opposite to the second layer member side.

[0230] <10> according to <2> to <9> The biosensor according to any one of the preceding claims, wherein the substrate comprises a polyurethane-based thermoplastic elastomer.

[0231] This application claims priority based on invention patent application No. 2023-17080 filed with the Japan Patent Office on February 7, 2023, and cites all the contents described in the above application.

[0232] Description of Reference Numerals

[0233] 1 Biosensor

[0234] 2 Skin

[0235] 10 First layer components

[0236] 11 Cover parts

[0237] 12 upper piece

[0238] 12A, 121A, 122A extensions

[0239] 12a, 111b, 121a, 122a through holes

[0240] 13 Moisture permeable membrane

[0241] 20, 20A, 20B electrodes

[0242] 30 Sensor unit

[0243] 31 Flexible Substrate

[0244] 32 sensor body

[0245] 33A, 33B connection

[0246] 34 Batteries

[0247] 40 Second layer components

[0248] 41 Second substrate

[0249] 42 adhesive layer for the lower part

[0250] 43 Second bonding layer

[0251] 44 groove

[0252] 111 protrusion

[0253] 111a Depression

[0254] 112A, 112B flat portion

[0255] 121 First Base Material

[0256] 122 first bonding layer

[0257] 123 The upper part is provided with an adhesive layer.

Claims

1. A biosensor, which is a biosensor attached to a living body, comprising: A sensor body for acquiring biological information; a first layer member having a shape protruding so as to cover the sensor body; a second layer member attached to a surface of the first layer member on a side opposite to the protruding direction and having an attachment surface for attachment to the living body; and a receiving space, enclosed by the first layer component and the second layer component, for receiving the sensor body; A moisture permeability of water vapor entering the storage space through the second layer component at a first temperature is smaller than a moisture permeability of water vapor discharged from the storage space through the first layer component at a second temperature, wherein the second temperature is lower than the first temperature.

2. The biosensor according to claim 1, wherein The first layer of components includes: a cover member having at least a portion of the storage space; and The base material is provided on the second layer member side of the cover member.

3. The biosensor according to claim 2, comprising: a through hole communicating with the receiving space of the cover member; as well as The moisture-permeable membrane is arranged in the through hole.

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

5. The biosensor according to claim 1, wherein An electrode connected to the sensor body is provided on a surface of the first layer member on the second layer member side. The biosensor according to claim 2 , wherein: An electrode connected to the sensor body is provided on a surface of the first layer component on the second layer component side. The first layer member has an adhesive layer on a surface of the substrate on the second layer member side, and the electrode is attached to the adhesive layer.

7. The biosensor according to claim 5 or 6, wherein: The second layer component is provided so that the electrode is exposed on the lower surface of the first layer component.

8. The biosensor according to claim 2, wherein The base material has a protruding portion on at least a portion of an outer periphery thereof, the protruding portion protruding beyond an outer periphery of at least one of the cover member and the second layer member.

9. The biosensor according to claim 2, wherein The first layer member has an adhesive layer on a surface of the substrate opposite to the second layer member side.

10. The biosensor according to claim 2, wherein The substrate comprises a polyurethane-based thermoplastic elastomer.

Images