Biological sensor

Abstract

A biological sensor according to the present invention is provided with: a sensor main body for acquiring biological information; an electrode connected to the sensor main body; a first layer member provided with a cover member having a housing space for housing the sensor main body, the electrode being provided on the lower surface thereof; and a second layer member attached to the lower surface of the first layer member so as to expose the electrode and cover the sensor main body. The cover member has a tensile modulus of 1.5 MPa or less and a relative permittivity of 2.2 or less.

Description

Technical Field

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

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

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

[0004] In this biosensor, while a first adhesive layer provided on the surface of the first layer component facing the biomolecule and a second adhesive layer provided on the surface of the second layer component facing the biomolecule are adhered to the skin, electrodes adhered to the first adhesive layer are brought into contact with the skin to obtain biomolecule information.

[0005] Prior art literature

[0006] Patent Literature

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

[0008] Problems to be solved by the invention

[0009] Here, if the biosensor is easily deformed and soft, the noise detected when acquiring the biometric information becomes larger, so the covering material is made of a material with high hardness such as silicone rubber. If the cover is made hard, the deformation of the biosensor is suppressed, thereby suppressing the generation of noise, but there is a possibility that the flexibility of the biosensor is reduced and it is difficult to deform following the deformation of the surface of the organism, and the adhesion to the biological surface such as the skin of the subject is deteriorated and it becomes easy to peel off.

[0010] Biosensors are often attached to the biological surface of the subject's skin or other living body surfaces and used for a long time. Therefore, in order to stably obtain electrical signals related to biological information for a long time, it is important to suppress the occurrence of noise in the detected electrical signals while maintaining the state of being stably attached to the biological surface.

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

[0012] Methods for solving problems

[0013] One aspect of the biosensor according to the present invention comprises:

[0014] The sensor body that acquires biological information,

[0015] An electrode connected to the sensor body,

[0016] The electrode is disposed below, and a first layer member includes a cover member having a storage space for storing the sensor body, and

[0017] A second layer member is attached to the lower surface of the first layer member so as to expose the electrode and cover the sensor body.

[0018] The covering member has a tensile elastic modulus of 1.5 MPa or less and a relative dielectric constant of 2.2 or less.

[0019] Effects of the Invention

[0020] One aspect of a biosensor according to the present invention can suppress the generation of noise during use and can be stably attached to a living body. BRIEF DESCRIPTION OF THE DRAWINGS

[0021] Figure 1 It is a perspective view showing the overall structure of a biosensor according to an embodiment of the present invention.

[0022] Figure 2 It is a plan view showing an example of each component of the biosensor.

[0023] Figure 3 is the cross-sectional view of the biosensor in the length direction, Figure 1 II cross-sectional view.

[0024] Figure 4 To express that Figure 1 An explanatory diagram showing a state in which the biosensor is attached to the chest of a living body.

[0025] Figure 5 This is an explanatory diagram showing an example of an electrocardiogram waveform without noise. DETAILED DESCRIPTION

[0026] The following is a detailed description of the embodiments of the present invention. In addition, in order to facilitate the understanding of the description, the same symbols are attached to the same components in each drawing, and repeated descriptions are omitted. In addition, the scales of the components in the drawings are sometimes different from the actual ones. In this specification, "to" indicating a numerical range means that the numerical values ​​recorded before and after it are included as the lower limit and upper limit unless otherwise specified.

[0027] <Biosensor>

[0028] The biosensor involved in this embodiment is described. In addition, the biosensor refers to the human body (human), as well as animals such as cows, horses, pigs, chickens, dogs and cats. The biosensor involved in this embodiment can be used for a biological body, and can be used as a human body. In this embodiment, as an example, the case where the biological body is a human is described.

[0029] The biosensor involved in this embodiment is a stick-on biosensor that is attached to a part of a living body (e.g., skin, scalp, or forehead) to measure biometric information. In this embodiment, a case where the biosensor is attached to a person's skin to measure an electrical signal (biometric signal) related to the person's biometric information is described.

[0030] Figure 1 It is a perspective view showing the overall structure of the biosensor according to the present embodiment. Figure 1 The left side of shows the appearance of the biosensor involved in this embodiment. Figure 1 The right side of shows a state in which the components of the biosensor according to the present embodiment are disassembled. Figure 2 It is a plan view showing an example of each component of the biosensor. Figure 3 is the cross-sectional view of the biosensor in the length direction, Figure 1 II cross-sectional view.

[0031] Figure 1 and Figure 2 As shown, the biosensor 1 is a plate-like (sheet-like) member formed in a substantially elliptical shape in a plan view. Figure 2 and Figure 3As shown in the figure, the biosensor 1 includes a first layer member 10, an electrode 20, a sensor portion 30, and a second layer member 40, and the first layer member 10, the electrode 20, and the second layer member 40 are stacked in order from the first layer member 10 side toward the second layer member 40 side. In the biosensor 1, the first layer member 10, the electrode 20, and the second layer member 40 form an adhesive surface for skin 2 as an example of a living body. The biosensor 1 adheres the adhesive surface to the skin 2, measures the potential difference (polarization voltage) between the skin 2 and the electrode 20, and thereby measures an electrical signal (biological signal) related to the biological information of the subject.

[0032] Figure 1 to Figure 3 In the present invention, a three-dimensional orthogonal coordinate system with three axes (X-axis, Y-axis, and Z-axis) is used, and the width direction of the biosensor is the X-axis, the length direction is the Y-axis, and the height direction (thickness direction) is the Z-axis. The opposite direction (outer side) of the biosensor 1 pasted on one side (paste side) of the biological body (test object) is set as the +Z-axis, and the pasting side is set as the -Z-axis. In the following description, for the convenience of explanation, the +Z-axis is sometimes set as the upper side or top, and the -Z-axis is set as the lower side or bottom, which does not represent a general up-down relationship.

[0033] In addition, the biological signal is an electrical signal indicating, for example, an electrocardiogram waveform, a brain wave, a pulse, or the like.

[0034] The inventors of the present application focused on the flexibility and charge amount of the covering member 11 provided on the surface side of the first layer member 10 when using the biosensor 1. Furthermore, the inventors of the present application found that by reducing the tensile elastic modulus and relative dielectric constant of the covering member 11, the close contact state with the biological surface of the electrode 20 is maintained and the close contact with the biological surface is improved, thereby suppressing the occurrence of noise detected when the biosensor 1 is used and improving the adhesion of the biosensor 1 to the biological body.

[0035] [1st layer components]

[0036] Figure 1 and Figure 2 As shown, the first layer member 10 is provided by sequentially laminating a cover member 11 and an upper sheet 12. The cover member 11 and the upper sheet 12 have substantially the same outer shape in a plan view.

[0037] (covering member)

[0038] Figure 3 As shown in the figure, the cover member 11 is located at the outermost side (+Z axis direction) of the biosensor 1 and is bonded to the upper surface of the upper sheet 12. The cover member 11 has a central portion in the longitudinal direction (Y axis direction) and has a central portion in the longitudinal direction (Y axis direction). Figure 1The cover member 11 includes a protrusion 111 that protrudes in a substantially hemispherical shape in the height direction (+Z axis direction) of the cover member 11, and flat portions 112A and 112B provided at both end sides in the length direction (Y axis direction) of the cover member 11. The upper and lower surfaces of the protrusion 111 and the upper and lower surfaces of the flat portions 112A and 112B are formed flatly.

[0039] The covering member 11 has an opening formed so as to have a concave pit 111a formed on the inner side (sticking side) of the protruding portion 111. The pit 111a only needs to have a size that can accommodate at least a part of the sensor portion 30. On the inner side (sticking side) of the protruding portion 111, the pit 111a on the inner surface of the portion 111, the electrode 20 and the second layer member 40 form a storage space S for accommodating the sensor portion 30.

[0040] As a material forming the cover member 11, for example, a flexible material such as a thermoplastic elastomer can be used. By forming the cover member 11 using the flexible material, the sensor unit 30 disposed in the storage space S of the cover member 11 is protected, and the impact applied to the biosensor 1 from the upper side is absorbed and the impact applied to the sensor unit 30 is mitigated.

[0041] As thermoplastic elastomer, polystyrene thermoplastic elastomer, polyolefin thermoplastic elastomer, polyester thermoplastic elastomer, urethane thermoplastic elastomer, polyvinyl chloride thermoplastic elastomer, polyamide thermoplastic elastomer, nitrile thermoplastic elastomer, nylon thermoplastic elastomer, fluororubber thermoplastic elastomer, polybutadiene thermoplastic elastomer, ethylene vinyl acetate thermoplastic elastomer, chlorinated polyethylene thermoplastic elastomer, styrene-butadiene block copolymer or its hydride, styrene-isoprene block copolymer or its hydride etc. can be enumerated. They can be used alone or in combination of two or more. Among these, preferably styrene thermoplastic elastomer, polyester thermoplastic elastomer, more preferably styrene thermoplastic elastomer.

[0042] Styrene-based thermoplastic elastomer is not particularly limited as long as it is a thermoplastic elastomer with styrene units (preferably styrene block units). As styrene-based thermoplastic elastomer, for example, styrene-isobutylene-styrene block copolymer (SIBS), styrene-isoprene-styrene block copolymer (SIS), styrene-isobutylene block copolymer (SIB), styrene-butadiene-styrene block copolymer (SBS), styrene-ethylene-butylene-styrene block copolymer (SEBS), styrene-ethylene-propylene-styrene block copolymer (SEPS), styrene-ethylene-ethylene-propylene-styrene block copolymer (SEEPS), styrene-butadiene-butylene-styrene block copolymer (SBBS) etc. can be cited. They can be used alone as one, and two or more can be used in combination. Among these, preferably SIS, SBS, SEBS, SBBS, more preferably SIS, SEBS.

[0043] As the thermoplastic elastomer, for example, thermoplastic elastomers manufactured and sold by Riccon Tech Co., Ltd., Aron Chemical Co., Ltd., DuPont Toray Co., Ltd., Kaneka Co., Ltd., Kraton Polymers Co., Ltd., Asahi Kasei Co., Ltd., etc. can be used.

[0044] The covering member 11 is generally formed using a thermosetting resin such as a cross-linked rubber, an epoxy resin, a phenol resin, a polyimide resin, an unsaturated polyester resin, and a diallyl phthalate resin. As the cross-linked rubber, for example, 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, halogenated butyl rubber, fluororubber, urethane rubber, and silicone rubber can be cited. If the covering member 11 is formed of a thermosetting resin, the hardness can be increased, so when measuring a biological signal, the waveform accuracy of the measured biological signal is suppressed, but there is a tendency that the adhesion to the biological surface is difficult to obtain sufficiently.

[0045] When the covering member 11 is an elastomer molded body formed of the above-mentioned thermoplastic elastomer, the elastomer molded body may be a non-porous elastomer molded body, or a porous elastomer molded body, preferably a porous elastomer molded body. The porous elastomer molded body may be a closed-cell foamed elastomer molded body (a porous elastomer molded body manufactured by foam molding to form closed cells) or a connected-cell foamed elastomer molded body (a porous elastomer molded body manufactured by foam molding to form connected cells).

[0046] The thickness of the top and side walls of the protrusion 111 may be thicker than the thickness of the flat portions 112A and 112B. This can reduce the flexibility of the protrusion 111 compared to the flexibility of the flat portions 112A and 112B, and protect the sensor unit 30 from external forces applied to the biosensor 1.

[0047] The thickness of the top surface and the side wall of the protrusion 111 can be appropriately designed, for example, 1.5 mm to 3 mm. The thickness of the flat portions 112A and 112B can also be appropriately designed, for example, 0.5 mm to 1 mm.

[0048] The thin flat portions 112A and 112B are more flexible than the protruding portion 111, so when the biosensor 1 is attached to the skin 2, it is easy to deform to follow the deformation of the surface of the skin 2 caused by body movements such as stretching, bending, and twisting. Therefore, when the surface of the skin 2 is deformed, the stress applied to the flat portions 112A and 112B can be alleviated, and the biosensor 1 can be difficult to peel off from the skin 2.

[0049] The outer periphery of the flat portions 112A and 112B may have a shape in which the thickness gradually decreases toward the ends. This can further improve the flexibility of the outer periphery of the flat portions 112A and 112B, and can improve the sense of installation when the biosensor 1 is attached to the skin 2, compared with a case where the thickness of the outer periphery of the flat portions 112A and 112B is not reduced.

[0050] The hardness of the covering member 11 can be designed to be any appropriate size, for example, preferably 10 to 40. The upper limit of the hardness is more preferably 30 or less. If the hardness of the covering member 11 is within the above preferred range, when the skin 2 is stretched by body movement, the upper sheet 12, the electrode 20 and the second layer member 40 can be easily deformed according to the movement of the skin 2 without being affected by the covering member 11. In addition, hardness (hardness) refers to Shore A hardness. In this specification, Shore A hardness refers to the hardness measured based on ISO7619 (JIS K6253-3: 2012). As described in "Vulcanized rubber and thermoplastic rubber-Method for determining hardness-Part 3: Durometer hardness" of JIS K 6253-3: 2012, the measured value of the Shore A hardness measured by making a sheet sample of the covering member 11 can be set as the Shore A hardness of the covering member 11.

[0051] The tensile modulus of the covering member 11 is, for example, preferably less than 1.5 MPa, more preferably less than 1.2 MPa, and further preferably less than 1.0 MPa at room temperature (23°C ± 2°C). If the tensile modulus of the covering member 11 is too high, the covering member 11 becomes hard and difficult to expand and contract. On the other hand, if the tensile modulus of the covering member 11 is too low, the covering member 11 is easy to expand and contract, and is easy to generate noise during use. Therefore, the tensile modulus of the covering member 11, for example, only needs to be less than 1.5 MPa. Thus, if the tensile modulus of the electrode 20 at room temperature (23°C ± 2°C) is less than 1.5 MPa, the covering member 11 can alleviate the stress generated by the deformation of the surface of the biological body, thereby being able to exert excellent elasticity relative to the surface of the skin 2.

[0052] The tensile modulus of the covering member 11 can be measured by a method according to JIS K7161: 2014 or the like. When the tensile modulus of the covering member 11 is determined according to JIS K7161: 2014, the covering member 11 is cut to make a rectangular test piece (sample) of a predetermined size (for example, 30 mm in length × 10 mm in width). The two ends of the test piece are clamped by chucks so that the distance between the chucks is 20 mm, and a tensile test is performed at room temperature (23°C) and a tensile speed of 30 mm / min to obtain a stress-strain curve. Based on the obtained stress-strain curve, the tensile modulus at room temperature (23°C ± 2°C) can be calculated by finding the inclination of the curve at two points where the strain is 0.05% and 0.25%. Specifically, when the value of the covering member 11 when the strain (unit: %) is 0.05% is set to ε1, the value when the strain is 0.25% is set to ε2, and the stresses (unit: MPa) corresponding to ε1 and ε2 are set to σ1 and σ2 respectively, the tensile modulus E (unit: MPa) at room temperature (23°C) is calculated by dividing the difference in stress (σ2-σ1) by the difference in strain (ε2-ε1) as shown in the following formula (1).

[0053] E=(σ2-σ1) / (ε2ーε1)···(1)

[0054] The relative dielectric constant of the covering member 11 is 2.2 or less, preferably 2.0 or less, and more preferably 1.8 or less. When the relative dielectric constant of the covering member 11 is 2.2 or less, impedance is increased and generation of noise is suppressed.

[0055] The relative dielectric constant of the covering member 11 can be determined using a general relative dielectric constant measurement method. For example, the covering member 11 can be cut to produce a test piece (sample) having a circular shape of a predetermined size (for example, a diameter of 38 mm or more). The capacitance (capacitance) C of the test piece is measured using an impedance analyzer, and the relative dielectric constant ε / ε0 is calculated from the capacitance C measured. Specifically, the value C×d obtained by multiplying the capacitance C of the test piece by the diameter d of the test piece is divided by the area S of the test piece and the dielectric constant ε0 of a vacuum (≒8.85×10 -12 F / m) squared (C×d / (S×ε0 2 )), thereby being able to calculate the relative dielectric constant (ε / ε0) of the covering member 11. In addition, the relative dielectric constant of the covering member 11 generally has a property of being dependent on the frequency. The biosensor 1 is used for measuring an electrocardiogram, and the frequency of the electrocardiogram is mainly several Hz to 30 Hz. Therefore, the frequency when calculating the relative dielectric constant can be 5 Hz.

[0056] The charge of the covering member 11 is preferably -1.0kV to 1.0kV, and more preferably -0.5kV to 0.5kV. If the charge of the covering member 11 is within the above range, the covering member 11 can suppress the charge that may be generated by the friction with the upper sheet 12 due to the deformation of the biosensor, etc. The charge of the covering member 11 can be measured using a general digital electrostatic potential measuring instrument. The measurement can be performed at an ambient temperature of about 23°C ± 2°C and an ambient humidity of about 40%. In addition, after a carrier film (manufactured by Nitto Denko Corporation, trade name "E-MASK") is attached to the covering member 11 for de-staticization, it is peeled off, and the charge of the covering member 11 can be measured after peeling off.

[0057] The adhesive force of the covering member 11 with respect to the adhesive can be set to an appropriate arbitrary size or less according to the type of the adhesive, etc. In the case where the adhesive is a silicone resin or an acrylic resin, the adhesive force of the covering member 11 with respect to the silicone resin or the acrylic resin can be set to be 1.7N / 10mm or more. The adhesive force of the covering member 11 with respect to the silicone resin or the acrylic resin is the peel strength of the covering member 11 from the silicone resin or the acrylic resin. If the covering member 11 has the above-mentioned adhesive force or more, the covering member 11 shows good adhesion to the upper sheet 12. In addition, the covering member 11 has the advantage of being easily attached to the upper sheet 12 by normal crimping.

[0058] The adhesive force of the covering member 11 with respect to the adhesive can be measured according to JIS Z 0237: 2000. For example, the covering member 11 is cut into a predetermined size (e.g., 10 mm in width and 100 mm in length) to prepare a test piece. One side of the test piece is pressed against a PET film having a predetermined thickness to which an adhesive material is attached to prepare a measurement sample. The above-mentioned pressing can be performed under the pressing condition that a 2 kg roller is reciprocated once.

[0059] After the test piece is pressed against the PET film, it can be aged for several minutes (for example, 30 minutes) at 23°C and 50% RH. As an adhesive material, the adhesive layer can use a double-sided adhesive tape formed by a silicone resin or an acrylic resin. The adhesive layer preferably has high adhesion. The adhesive layer is a double-sided adhesive tape formed by a silicone resin, and specifically, ST503 (manufactured by Nitto Denko Corporation) can be used. The adhesive layer is a double-sided adhesive tape formed by an acrylic resin, and specifically, PKE-20 (manufactured by Nitto Denko Corporation) can be used. After aging, according to JIS Z 0237, at 25°C and 50% RH, the measured sample is peeled off from the PET film using a tensile testing machine at a tensile speed of 300 mm / min and a peeling angle of 180°, and the 180° peeling adhesion (unit: N / 10mm) is measured. As a tensile testing machine, "Precision Universal Testing Machine Autograph AG-IS 50N" manufactured by Shimadzu Corporation or the like can be used.

[0060] (Upper piece)

[0061] Figure 3 As shown in the figure, the upper sheet 12 is bonded to the lower surface of the cover member 11. The upper sheet 12 has a through hole 12a at a position opposite to the protrusion 111 of the cover member 11. Through the through hole 12a, the sensor body 32 of the sensor unit 30 is not blocked by the upper sheet 12, and can be stored in the storage space S formed by the recess 111a on the inner surface of the cover member 11 and the through hole 12a.

[0062] The upper sheet 12 includes a first substrate 121 , a first adhesive layer 122 having the electrode 20 adhered to a surface of the first substrate 121 facing the electrode 20 , and an upper adhesive layer 123 provided on a surface opposite to the surface of the first substrate 121 facing the electrode 20 .

[0063] ((First base material))

[0064] Figure 3 As shown, the first base material 121 is provided on the pasting side which is the opening side of the cover member 11 . Figure 1As shown in FIG. 1 , the first substrate 121 is formed in a sheet shape. The first substrate 121 has a porous structure and can be formed using a porous body having flexibility, waterproofness, and moisture permeability. As the porous body, for example, a foaming raw material (foam) having a bubble structure such as open bubbles, independent bubbles, or semi-independent bubbles can be used. Thus, water vapor brought by sweat or the like generated from the skin 2 to which the biosensor 1 is attached can be released to the outside of the biosensor 1 through the first substrate 121.

[0065] The moisture permeability of the first substrate 121 is preferably 100 g / (m 2 ·day)~5000g / (m 2 ·day). By setting the moisture permeability of the first substrate 121 to 100 g / (m 2 ·day)~5000g / (m 2 ·day), so that the first substrate 121 can allow water vapor that penetrates from one side to pass through the first substrate 121 and be stably released from the other side.

[0066] As a material forming the first substrate 121, for example, thermoplastic resins such as polyurethane resins, polystyrene resins, polyolefin resins, silicone resins, acrylic resins, vinyl chloride resins, and polyester resins can be used. As the first substrate 121, for example, FOLEC manufactured by INOAC CORPORATION can be used.

[0067] The thickness of the first substrate 121 can be appropriately set, and may be, for example, 0.5 mm to 1.5 mm.

[0068] The first base material 121 has a through hole 121a at a position facing the protruding portion 111 of the cover member 11. By providing the first adhesive layer 122 and the upper adhesive layer 123 on the surface other than the through hole 121a of the first base material 121, through holes 122a and 123a can be formed in the first adhesive layer 122 and the upper adhesive layer 123. The through holes 121a, 122a, and 123a form the through hole 12a.

[0069] In addition, the first substrate 121 may be a substrate without a porous structure as long as it has flexibility, waterproofness, and moisture permeability. The first substrate 121 has flexibility, waterproofness, and moisture permeability, so that the first substrate 121 is easy to extend in contact with the skin 2, and can maintain the state of contact with the skin 2, and can suppress the intrusion of liquid into the gap between the first substrate 121 and the upper adhesive layer 123. In addition, water vapor brought by sweat or the like generated by the skin 2 to which the biosensor 1 is attached can be released to the outside of the biosensor 1 through the first substrate 121. Therefore, the upper sheet 12 is easy to maintain the bonding durability.

[0070] As the material of the substrate without a porous structure, as described above, for example, thermoplastic resins such as polyurethane resins, polystyrene resins, polyolefin resins, silicone resins, acrylic resins, vinyl chloride resins, and polyester resins can be used. In the case where the first substrate 121 is a material of a substrate without a porous structure, as the first substrate 121, for example, a polyurethane sheet such as S-URS manufactured by Japan Matai can be used.

[0071] ((First adhesive layer))

[0072] Figure 3 As shown, the first adhesive layer 122 is provided in a state of being adhered to the surface of the first substrate 121 that is opposite to the electrode 20. The first adhesive layer 122 is located on the surface of the first substrate 121 on the biological body side (-Z axial direction), and has the functions of bonding the skin 2 to the first substrate 121, bonding the first substrate 121 to the second substrate 41, and bonding the first substrate 121 to the electrode 20.

[0073] The first adhesive layer 122 may have moisture permeability. Thus, as described later, water vapor caused by sweat or the like generated by the skin 2 to which the biosensor 1 is attached can escape to the first base material 121 through the first adhesive layer 122, and be released from the first base material 121 to the outside of the biosensor 1. When the first base material 121 has a bubble structure as described above, water vapor can be released to the outside of the biosensor 1 through the first adhesive layer 122. Thus, it is possible to suppress sweat or water vapor from being retained at the interface between the skin 2 to which the biosensor 1 is attached and the first layer member 10. As a result, the moisture retained at the interface between the skin 2 and the first adhesive layer 122 weakens the adhesive force of the first adhesive layer 122, and it is possible to suppress the biosensor 1 from peeling off from the skin 2.

[0074] The moisture permeability of the first adhesive layer 122 is preferably, for example, 1 g / (m 2 The moisture permeability of the first adhesive layer 122 can be 10000 g / (m 2 If the moisture permeability of the first adhesive layer 122 is 1g / (m 2 · days) or more, when the first adhesive layer 122 is attached to the skin 2, sweat and the like conducted from the first adhesive layer 122 can be transmitted to the outside, thereby reducing the load on the skin 2.

[0075] As a material forming the first adhesive layer 122, a material having pressure-sensitive adhesive properties is preferable, and for example, an acrylic pressure-sensitive adhesive can be used.

[0076] The first adhesive layer 122 may be an adhesive tape formed of the above-mentioned materials. When the cover member 11 is stacked on the first adhesive layer 122 to form the biosensor 1, the waterproof property of the biosensor 1 can be improved, and the bonding strength with the cover member 11 can be improved.

[0077] The first adhesive layer 122 can be formed with a wave-shaped pattern (reticular pattern) formed by repeated alternation of recessed portions thinner than other portions (or having a thickness of zero) on its surface. As the first adhesive layer 122, for example, an adhesive tape having a reticular pattern formed on its surface can be used. The first adhesive layer 122 has a reticular pattern on its surface, so that both the portion where the adhesive on the surface of the first adhesive layer 122 is easy to contact with the organism and the portion where it is difficult to contact with the organism exist. Since both the portion where the adhesive exists and the portion where the adhesive does not exist exist on the surface of the first adhesive layer 122, the portion that is easy to contact with the organism can be dotted on the surface of the first adhesive layer 122. The thinner the adhesive is, the easier it is to increase the moisture permeability of the first adhesive layer 122. Therefore, the first adhesive layer 122 forms a reticular pattern on its surface, and has a portion where the thickness of the adhesive is partially thin, so that compared with the case where the reticular pattern is not formed, it is possible to maintain adhesion while improving moisture permeability. In addition, the shape of the concave portion may be a linear shape or a circular shape other than a wave shape.

[0078] The thickness of the first adhesive layer 122 can be set arbitrarily and is preferably 10 μm to 300 μm, more preferably 50 μm to 200 μm, and further preferably 70 μm to 110 μm. When the thickness of the first adhesive layer 122 is 10 μm to 300 μm, the biosensor 1 can be made thinner.

[0079] ((Adhesive layer for the upper part))

[0080] Figure 3 As shown in the figure, the upper adhesive layer 123 is provided in a state of being attached to the surface opposite to the surface of the first substrate 121 that faces the electrode 20. The upper adhesive layer 123 is attached to a position corresponding to the flat surface of the attachment side (-Z axial direction) of the cover member 11 on the upper surface of the first substrate 121, and has the function of bonding the first substrate 121 and the cover member 11.

[0081] As a material forming the upper adhesive layer 123 , a silicone-based adhesive, a silicone tape, or the like can be used.

[0082] The thickness of the upper adhesive layer 123 can be appropriately set, and can be set to, for example, 10 μm to 300 μm.

[0083] [electrode]

[0084] Figure 3As shown in FIG. 1 , the electrode 20 is attached to the skin 2 by connecting a portion of the sensor body 32 side of the electrode 20 to the wiring 331A and 331B below the surface of the attachment side (-Z axis direction) of the first adhesive layer 122, and sandwiching the first adhesive layer 122 and the lower adhesive layer 42. The portion of the electrode 20 that is not sandwiched between the first adhesive layer 122 and the lower adhesive layer 42 is in contact with the biological body. When the biosensor 1 is attached to the skin 2, the electrode 20 is in contact with the skin 2, thereby being able to detect a biological signal. In addition, the electrode 20 can be buried in a state where it is exposed so that the second substrate 41 can contact the skin 2.

[0085] The electrode 20 is composed of a pair of electrodes 20A and 20B. Figure 3 As shown in the figure, the electrode 20A is arranged on the left side in the figure, and the electrode 20B is arranged on the right side in the figure. The electrode 20A contacts the terminal portion 332A at one end side (inner side) in the length direction (Y-axis direction), and the electrode 20B contacts the terminal portion 332B at one end side (inner side) in the length direction (Y-axis direction). The pair of electrodes 20A and 20B have substantially the same shape.

[0086] In addition, one end side of the electrode 20A in contact with the terminal portion 332A of the sensor portion 30 is set as the opposing portion 201A, and one end side of the electrode 20B in contact with the terminal portion 332B of the sensor portion 30 is set as the opposing portion 201B. The portion of the electrode 20A that is not in contact with the terminal portion 332A (the other end side (outer side) in the length direction (Y-axis direction)) is set as the exposed portion 202A, and the portion of the electrode 20B that is not in contact with the terminal portion 332B (the other end side (outer side) in the length direction (Y-axis direction)) is set as the exposed portion 202B.

[0087] The electrode 20 may have any shape such as a sheet shape.

[0088] The shape of the electrode 20 when viewed from above is not particularly limited, and can be designed to any appropriate shape depending on the application, etc. The electrodes 20A and 20B are each as shown in FIG. Figure 2 As shown, in a plan view, the facing portions 201A and 201B on one end side may be formed in a rectangular shape, and the exposed portions 202A and 202B on the other end side may be formed in an arc shape.

[0089] Electrodes 20A and 20B are as follows Figure 2 and Figure 3As shown in FIG. 1 , the electrode 20 may have through holes 203A and 203B which are elongated in the width direction (X-axis direction) and are arranged at one end side (inner side) in the length direction (Y-axis direction), and through holes 204A and 204B which are circular in shape and are arranged at the other end side (outer side) in the length direction (Y-axis direction). Thus, the electrode 20 can be exposed to the pasting side from the through holes 203A and 203B, and the through holes 204A and 204B in a state of being pasted to the first adhesive layer 122, thereby improving the adhesion between the electrode 20 and the skin 2. In addition, the number of through holes 203A and 203B, and through holes 204A and 204B is not particularly limited, and can be appropriately set according to the size of the opposing parts 201A and 201B of the electrode 20.

[0090] The electrode 20 can be formed using a cured product of a conductive composition containing a conductive polymer and a binder resin, a metal, an alloy, etc. Among them, from the perspective of the safety of the organism, such as no allergic reaction occurs when the electrode 20 is applied to the organism, the electrode 20 is preferably formed using a cured product of the conductive composition. The electrode 20 can be an adhesive electrode sheet formed in a sheet form using a cured product of the conductive composition.

[0091] As the conductive polymer, for example, polythiophene conductive polymers, polyaniline conductive polymers, polyacetylene conductive polymers, polypyrrole conductive polymers, polyphenylene conductive polymers and derivatives thereof, and composites thereof, etc. can be used. Among these, a composite in which polythiophene is doped with polyaniline as a dopant is preferred. Among the composites of polythiophene and polyaniline, from the perspective of lower contact impedance with a biological body and high conductivity, PEDOT / PSS in which polystyrene sulfonic acid (poly-4-styrene sulfonate; PSS) as polyaniline is doped in poly (3,4-ethylenedioxythiophene) (also referred to as PEDOT) as polythiophene is more preferably used.

[0092] As the binder resin, a water-soluble polymer or a water-insoluble polymer can be used. As the water-soluble polymer, a polymer containing a hydroxyl group such as polyvinyl alcohol (PVA) and modified PVA can be used.

[0093] The conductive composition may contain various common additives such as a crosslinking agent and a plasticizer in an appropriate and arbitrary ratio. Examples of the crosslinking agent include aldehyde compounds such as sodium glyoxylate. Examples of the plasticizer include glycerin, ethylene glycol, propylene glycol, and the like.

[0094] As the metal and the alloy, general metals and alloys such as Au, Pt, Ag, Cu, and Al can be used.

[0095] The thickness of the electrode 20 can be set to any appropriate height, and can be, for example, 10 μm to 100 μm. When the thickness of the electrode 20 is within the above-described preferred range, sufficient strength and flexibility can be imparted to the electrode 20 .

[0096] The thickness of the electrode 20 refers to the length in the direction perpendicular to the surface of the electrode 20. The thickness of the electrode 20 is, for example, the thickness when measuring any location in the cross section of the electrode 20. When measuring multiple locations at any location, it may be the average value of the thicknesses at these measurement locations.

[0097] (Sensor part)

[0098] Figure 3 As shown, the sensor section 30 includes a flexible substrate 31 , a sensor body 32 , and connection sections 33A and 33B connected to the sensor body 32 .

[0099] The flexible substrate 31 is a resin substrate on which various components for acquiring biological information are mounted, and the flexible substrate 31 includes a sensor body 32 and connection portions 33A and 33B.

[0100] Figure 2 As shown, the sensor body 32 includes a component mounting portion 321 and a battery mounting portion 322 as a control portion, and acquires biological information.

[0101] The component mounting section 321 includes a CPU and an integrated circuit that processes a biological signal obtained from a living body to generate biological signal data, a switch SW that activates the biological sensor 1, a flash memory that stores biological signals, and various components mounted on the flexible substrate 31 such as a light emitting element, and obtains biological information. In addition, examples of circuits including various components are omitted. The component mounting section 321 operates by power supplied by the battery 34 installed in the battery installation section 322.

[0102] The component mounting unit 321 transmits the information to an external device such as an operation confirmation device that confirms the initial operation or a reading device that reads the biological information from the biosensor 1 by wire or wirelessly.

[0103] The battery mounting portion 322 is disposed between the connection portion 33A and the component mounting portion 321, and supplies power to the integrated circuit and the like mounted on the component mounting portion 321. Figure 2 As shown, a battery 34 is installed.

[0104] The connecting parts 33A and 33B have: wirings 331A and 331B respectively connected to the sensor body 32 in the length direction (Y-axis direction) of the sensor body 32, and terminal parts 332A and 332B arranged on the front end side of the wirings 331A and 331B and connected to the electrode 20.

[0105] One end of the wiring 331A and 331B is as follows Figure 3 As shown, each is connected to an electrode 20 . Figure 3 As shown, the other end of the wiring 331A is connected to the switch SW etc. mounted on the component mounting portion 321 along the outer circumference of the sensor body 32. The other end of the wiring 331B is connected to the switch SW etc. mounted on the component mounting portion 321.

[0106] The terminals 332A and 332B are connected to the wirings 331A and 331B at one end and are arranged in a state of being sandwiched between the first layer member 10 and the second layer member 40 while the top surfaces of the other ends are in contact with the electrode 20 .

[0107] A known battery can be used as the battery 34. As the battery 34, for example, a button-type battery such as CR2025 can be used.

[0108] [Layer 2 components]

[0109] Figure 3 As shown, the second layer member 40 is provided on the attachment surface side of the electrode 20 and the sensor section 30 , is a support substrate on which the sensor section 30 is provided, and forms a part of the attachment surface to the skin 2 . Figure 1 and Figure 2 As shown, the outer shape of both sides of the width direction (X-axis direction) of the second layer member 40 can be substantially the same as the outer shape of both sides of the width direction (X-axis direction) of the first layer member 10. The length (Y-axis direction) of the second layer member 40 is formed shorter than the length (Y-axis direction) of the covering member 11 and the upper sheet 12. Figure 3 As shown, both ends of the second layer member 40 in the longitudinal direction are located so as to sandwich the wirings 331A and 331B of the sensor unit 30 between the second layer member 40 and the upper sheet 12 , that is, to overlap with a part of the electrode 20 .

[0110] The second layer member 40 includes a second base material 41, a lower adhesive layer 42 provided on the upper surface of the second base material 41, and a second adhesive layer 43 provided on the lower surface of the second base material 41. The second base material 41, the lower adhesive layer 42, and the second adhesive layer 43 may be formed in the same shape when viewed from above. The second adhesive layer 43 of the second layer member 40 and the electrode 20 form an adhesive surface for the skin 2. The waterproofness and moisture permeability are different according to the area of ​​the electrode 20 and the second adhesive layer 43, and the adhesiveness can be made different. Thus, the waterproofness and moisture permeability can be made different according to the area of ​​the adhesive surface of the second adhesive layer 43, and the adhesiveness can be made different.

[0111] (Second base material)

[0112] The second base material 41 can be formed using a flexible resin having appropriate stretchability, flexibility, and toughness. As the material forming the second substrate 41, for example, polyester resins such as polyethylene terephthalate (PET), polybutylene terephthalate, polyethylene terephthalate, polyethylene naphthalate, and polybutylene naphthalate; acrylic resins such as polyacrylic acid, polymethacrylic acid, polymethyl acrylate, polymethyl methacrylate (PMMA), polyethyl methacrylate, and polybutyl acrylate; polyolefin resins such as polyethylene and polypropylene; polystyrene resins such as polystyrene, imide-modified polystyrene, acrylonitrile-butadiene-styrene (ABS) resin, imide-modified ABS resin, styrene-acrylonitrile copolymer (SAN) resin, and acrylonitrile-ethylene-propylene-diene-styrene (AES) resin; polyimide resin; polyurethane resin; silicone resin; polyvinyl chloride resins such as polyvinyl chloride and ethylene-vinyl acetate copolymer resin, and the like can be used. Among these, polyolefin resins and PET are preferably used. These thermoplastic resins have water-repellent properties (low water permeability) that prevent water and water vapor from penetrating. Therefore, the second substrate 41 is formed using these thermoplastic resins, so that sweat or water vapor generated by the skin 2 of the living body can be prevented from passing through the second substrate 41 and invading the flexible substrate 31 side of the sensor unit 30 when the biosensor 1 is attached to the skin 2 of the living body.

[0113] The second base material 41 is preferably formed in a flat plate shape because the sensor section 30 is provided on the upper surface thereof via the lower adhesive layer 42 .

[0114] The thickness of the second substrate 41 can be appropriately and arbitrarily selected, and can be, for example, 1 μm to 300 μm.

[0115] (Adhesive layer at the bottom)

[0116] Figure 3 As shown, the lower adhesive layer 42 is arranged on the upper side of the covering member 11 side (+Z axial direction) of the second substrate 41, and the sensor part 30 is bonded. The two end sides of the lower adhesive layer 42 of the second layer member 40 in the length direction are arranged at positions opposite to the opposing parts 201A and 201B of the electrode 20. As a result, the opposing parts 201A and 201B of the electrode 20 can be sandwiched between the upper sheet 12 and the second layer member 40 in a state where the terminal parts 332A and 332B are pushed, and the electrode 20 can be connected to the terminal parts 332A and 332B. The lower adhesive layer 42 can use the same material as the second adhesive layer 43 described later, so the details are omitted. In addition, the lower adhesive layer 42 does not need to be provided and can be omitted.

[0117] (Second adhesive layer)

[0118] Figure 3 As shown, the second adhesive layer 43 is provided on the lower surface of the sticking side (-Z axis direction) of the second base material 41 and is a layer in contact with the living body.

[0119] The second adhesive layer 43 preferably has pressure-sensitive adhesiveness. Since the second adhesive layer 43 has pressure-sensitive adhesiveness, the biosensor 1 can be easily attached to the skin 2 by being pressed against the skin 2 of a living body.

[0120] The material of the second adhesive layer 43 is not particularly limited as long as it is a material having pressure-sensitive adhesive properties, and materials having biocompatibility can be cited. As the material forming the second adhesive layer 43, acrylic pressure-sensitive adhesives, silicone pressure-sensitive adhesives, etc. can be cited. Preferably, acrylic pressure-sensitive adhesives can be cited.

[0121] The acrylic pressure-sensitive adhesive preferably contains an acrylic polymer as a main component. The acrylic polymer can function as a pressure-sensitive adhesive component. As the acrylic polymer, a polymer obtained by polymerizing a (meth)acrylate containing isononyl acrylate, methoxyethyl acrylate, etc. as a main component and a monomer copolymerizable with a (meth)acrylate such as acrylic acid as an arbitrary component can be used.

[0122] The acrylic pressure-sensitive adhesive preferably further contains a carboxylate. The carboxylate acts as a pressure-sensitive adhesive force regulator that reduces the pressure-sensitive adhesive force of the acrylic polymer and adjusts the pressure-sensitive adhesive force of the second adhesive layer 43. The carboxylate can be a carboxylate that is compatible with the acrylic polymer. As the carboxylate, triglycerides and the like can be used.

[0123] Acrylic pressure-sensitive adhesive can contain a cross-linking agent as required. The cross-linking agent is a cross-linking component that cross-links an acrylic polymer. As the cross-linking agent, polyisocyanate compounds (multifunctional isocyanate compounds), epoxy compounds, melamine compounds, peroxide compounds, urea compounds, metal alkoxide compounds, metal chelates, metal salt compounds, carbodiimide compounds, oxazoline compounds, aziridine compounds, amine compounds, etc. can be cited. Among these, polyisocyanate compounds are preferably used. These cross-linking agents can be used alone or in combination.

[0124] The second adhesive layer 43 preferably has excellent biocompatibility. For example, when the second adhesive layer 43 is subjected to a keratin peeling test, the keratin peeling area ratio is preferably 0% to 50%. If the keratin peeling area ratio is within the range of 0% to 50%, even if the second adhesive layer 43 is attached to the skin 2, the load on the skin 2 can be suppressed.

[0125] The second adhesive layer 43 preferably has moisture permeability. Water vapor and the like generated by the skin 2 to which the biosensor 1 is attached can escape to the upper sheet 12 side through the second adhesive layer 43. In addition, as described later, the upper sheet 12 has a bubble structure, so that water vapor can be released to the outside of the biosensor 1 through the second adhesive layer 43. As a result, it is possible to suppress the retention of sweat or water vapor at the interface between the skin 2 to which the biosensor 1 is attached and the second adhesive layer 43. As a result, the moisture accumulated at the interface between the skin 2 and the second adhesive layer 43 weakens the adhesive force of the second adhesive layer 43, and it is possible to suppress the biosensor 1 from peeling off from the skin.

[0126] The moisture permeability of the second adhesive layer 43 is preferably, for example, 300 g / (m 2 ·day)~10000g / (m 2 If the moisture permeability of the second adhesive layer 43 is within the above-mentioned preferred range, even when the second adhesive layer 43 is attached to the skin 2, sweat generated from the skin 2 can be appropriately transmitted from the second adhesive layer 43 to the outside, thereby reducing the burden on the skin 2.

[0127] The thickness of the second adhesive layer 43 can be appropriately selected, but is preferably 10 μm to 300 μm. When the thickness of the second adhesive layer 43 is 10 μm to 300 μm, the biosensor 1 can be made thinner.

[0128] Figure 1 and Figure 2 As shown in the figure, when the biosensor 1 is not in use, the electrode 20 and the second layer member 40 are protected on the biosensor's attachment surface between the electrode 20 and the second substrate 41. Therefore, it is preferable to attach a release liner 50 until use. When in use, the release liner 50 is peeled off from the electrode 20 and the second layer member 40, and the attachment surface of the biosensor 1 is attached to the skin 2. By attaching the release liner 50 to the attachment surface, the adhesion between the electrode 20 and the second layer member 40 can be maintained even if the biosensor 1 is stored for a long time. Therefore, by peeling the release liner 50 from the second layer member 40 and the electrode 20 when in use, the attachment surface can be securely attached to the skin 2 for use.

[0129] The method for producing the biosensor 1 is not particularly limited, and the biosensor 1 can be produced using any appropriate method. An example of a method for producing the biosensor 1 will be described.

[0130] Prepare Figure 1 and Figure 2 The first layer member 10, the electrode 20, the sensor portion 30 and the second layer member 40 are shown. The first layer member 10, the electrode 20, the sensor portion 30 and the second layer member 40 are not particularly limited as long as the method for manufacturing them can be used, and can be manufactured using any appropriate manufacturing method.

[0131] Prepare to pose Figure 1 After the first layer member 10, the electrode 20, the sensor portion 30 and the second layer member 40 of the biosensor 1 shown in the figure are stacked, the sensor portion 30 is placed on the second layer member 40. Then, from the first layer member 10 side toward the second layer member 40 side, the first layer member 10, the electrode 20, the sensor portion 30 and the second layer member 40 are stacked in order. Thus, a Figure 1 The biosensor 1 is shown.

[0132] Figure 4 To express Figure 1 1 is an explanatory diagram showing a state where the biosensor 1 is attached to the chest of a subject P. Figure 4 As shown, for example, the biosensor 1 is placed on the sternum of the subject P in the longitudinal direction (Y-axis direction), with one electrode 20 on the upper side and the other electrode 20 on the lower side, and is attached to the skin of the subject P. The biosensor 1 is formed by using Figure 2 The second adhesive layer 43 is adhered to the skin of the subject P, so that the electrode 20 is pressed against the skin of the subject P, and a biological signal such as an electrocardiogram signal is obtained from the subject P through the electrode 20. The biosensor 1 stores the obtained biological signal data in a non-volatile memory such as a flash memory mounted on the component mounting portion 321.

[0133] Thus, the biosensor 1 includes the first layer member 10, the electrode 20, the sensor body 32, and the second layer member 40, and the tensile modulus of the covering member 11 included in the first layer member 10 is set to be 1.5 MPa or less, and the relative dielectric constant is set to be 2.2 or less. By setting the tensile modulus of the covering member 11 to be 1.5 MPa or less, the covering member 11 becomes soft, and the elongation of the biosensor 1 in the longitudinal direction can be easily extended, and the adhesion of the biosensor 1 to the surface of the skin 2 can be improved. In addition, the lower the relative dielectric constant of the biosensor 1, the smaller the electrostatic capacitance, thereby having a tendency to suppress the generation of current caused by the charge during the body movement, and reduce the noise. Therefore, by setting the relative dielectric constant of the covering member 11 to be 2.2 or less, the impedance of the biosensor 1 can be reduced, and the contact impedance of the biosensor 1 can be suppressed, and the generation of noise can be suppressed. As a result, the biosensor 1 can suppress the generation of noise during use and can be stably attached to the skin 2.

[0134] Therefore, the biosensor 1 can improve the accuracy of the electrocardiogram waveform measured as a biosignal during electrocardiogram measurement and improve the adhesion to the surface of the skin 2 .

[0135] In addition, the evaluation method of the accuracy of the electrocardiogram waveform is not particularly limited, and a general evaluation method can be used. Figure 5 As shown in FIG. 1 , the determination coefficient (RRI determination coefficient) R of the interval (RRI) between the highest point R of the QRS wave and the highest point R of the next adjacent QRS wave can be obtained in the electrocardiogram waveform appearing as the P wave, QRS wave, and T wave. 2 And make an evaluation.

[0136] The biosensor 1 can include a thermoplastic elastomer in the cover member 11. The thermoplastic elastomer has high flexibility and a low relative dielectric constant, thereby improving the flexibility of the cover member 11 and reducing the electrostatic capacitance. Therefore, the biosensor 1 is configured such that the cover member 11 includes a thermoplastic elastomer, thereby reliably suppressing noise generated during use and stably maintaining adhesion to the surface of the skin 2.

[0137] The biosensor 1 can use a styrene-based thermoplastic elastomer as the thermoplastic elastomer. Among thermoplastic elastomers, the styrene-based thermoplastic elastomer has higher flexibility and lower relative dielectric constant, so the flexibility of the cover member 11 can be further improved and the electrostatic capacitance can be further reduced. Therefore, the biosensor 1 uses a styrene-based thermoplastic elastomer as the thermoplastic elastomer in the cover member 11, so that the noise generated during use can be more reliably suppressed and the adhesion to the surface of the skin 2 can be more stably maintained.

[0138] The first layer member 10 of the biosensor 1 can include a first substrate 121, a first adhesive layer 122, and an upper adhesive layer 123. The first adhesive layer 122 has adhesiveness, so the electrode 20 can contact the surface of the skin 2 while being attached to the first layer member 10 via the first adhesive layer 122. Thus, the biosensor 1 maintains a state where the electrode 20 is stably attached to the skin 2, and even when the body moves, positional displacement can be suppressed, thereby reducing the contact impedance between the electrode 20 and the surface of the skin 2, suppressing the generation of noise, and more stably attaching to the skin 2. Thus, the biosensor 1 can improve the detection accuracy of the biological signal during use, and maintain adhesion to the skin 2.

[0139] The biosensor 1 can include a second adhesive layer 43 on the surface of the second layer member 40 on the opposite side to the first layer member 10 side. Thus, the biosensor 1 can adhere the second layer member 40 to the skin 2 via the second adhesive layer 43, thereby further reducing the contact impedance between the electrode 20 and the surface of the skin 2 and suppressing the generation of noise. Thus, the biosensor 1 can stably suppress the generation of noise during use and maintain adhesion to the skin 2.

[0140] The biosensor 1 can form a bonding surface to the skin 2 by the first layer member 10, the electrode 20 and the second layer member 40. Thus, the thickness of the biosensor 1 can be reduced. Thus, the biosensor 1 can be made smaller and have lower contact impedance with the surface of the skin 2.

[0141] Thus, the biosensor 1 can stably measure the biometric information from the skin 2 for a long time during use as described above, and can be effectively used as a stick-on biosensor to be used by being stuck to the human skin 2. The biosensor 1 can be stuck to the skin of a living body, for example, and is suitable for use in a wearable device for health that requires high sensitivity in detecting an electrocardiogram and high suppression effect of noise generated by the electrocardiogram.

[0142] As described above, the embodiments are described, but the above embodiments are provided as examples, and the present invention is not limited by the above embodiments. The above embodiments can be implemented in various other forms, and various combinations, omissions, substitutions, changes, etc. can be made within the scope of the subject matter of the invention. These embodiments and their variations are included in the scope and subject matter of the invention, and are included in the invention described in the claims and their equivalents.

[0143] 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] <Example 1>

[0146] [Fabrication of Covering Member and Measurement of Physical Properties]

[0147] (Production of Covering Member)

[0148] (1) Fabrication of Covering Member 1

[0149] Thermoplastic elastomer 1 (LIR9826N, manufactured by Rincon Technology Corporation) was used as a base resin and molded into a predetermined shape to produce the covering member 1 .

[0150] (2) Fabrication of Covering Member 2

[0151] Thermoplastic elastomer 2 (AR-830C, manufactured by Aron Chemical Industry Co., Ltd.) was used as a base resin and molded into a predetermined shape to produce the covering member 2 .

[0152] (3) Fabrication of Covering Member 3

[0153] Silicone rubber 1 (CHN-9300-U, manufactured by Topco) and silicone rubber 2 (CHN-9500-U, manufactured by Topco) were mixed at a ratio of 1:1 to prepare a mixture having a Shore A hardness of 40. The mixture was used as a base resin and molded into a predetermined shape to prepare a covering member 3.

[0154] (4) Fabrication of Covering Member 4

[0155] Silicone rubber 3 (CHN-9400-U, manufactured by Topco) and silicone rubber 4 (CHN-9600-U, manufactured by Topco) were mixed at a ratio of 1:1 to prepare a mixture having a Shore A hardness of 50. The mixture was used as a base resin and molded into a predetermined shape to prepare a cover member 4.

[0156] (5) Fabrication of Covering Member 5

[0157] Silicone rubber 2 (CHN-9500-U, manufactured by Topco) and silicone rubber 5 (CHN-9700-U, manufactured by Topco) were mixed at a ratio of 1:1 to prepare a mixture having a Shore A hardness of 60. The mixture was used as a base resin and molded into a predetermined shape to prepare a cover member 5.

[0158] (6) Fabrication of Covering Member 6

[0159] Silicone rubber 4 (CHN-9600-U, manufactured by Topco) and silicone rubber 6 (CHN-9800-U, manufactured by Topco) were mixed at a ratio of 1:1 to prepare a mixture having a Shore A hardness of 70. The mixture was used as a base resin and molded into a predetermined shape to prepare a cover member 6.

[0160] (7) Fabrication of Covering Member 7

[0161] A mixture having a Shore A hardness of 80 was prepared using silicone rubber 6 (CHN-9800-U, manufactured by Topco Corporation). The mixture was used as a base resin and molded into a predetermined shape to produce the covering member 7 .

[0162] (8) Fabrication of Covering Member 8

[0163] Thermoplastic elastomer 2 (Hitrel (registered trademark) SB654, manufactured by DuPont Toray Co., Ltd.) was used as a base resin and molded into a predetermined shape to produce the covering member 8 .

[0164] (Measurement of Physical Properties of Covering Member)

[0165] As the physical properties of the covering members 1 to 8, Shore A hardness, tensile elastic modulus, charge amount, relative dielectric constant and adhesive strength were measured.

[0166] (1) Shore A hardness

[0167] Sheet samples (length 60 mm×width 60 mm×thickness 10 mm) of the thermoplastic elastomer or mixture constituting the covering members 1 to 8 were prepared as test pieces. Based on JIS K 6253-3:2012 "Rubber, vulcanized and thermoplastic rubber - Method for determining hardness - Part 3: Durometer hardness", the test pieces were measured using an A-type durometer at a distance of 15 mm from the ends of the test pieces (thickness 10 mm) of the covering members 1 to 8. The measured values ​​of the test pieces were set as the Shore A hardness of each of the covering members 1 to 8.

[0168] (2) Tensile elastic modulus

[0169] According to JIS K7161:2014, cover members 1 to 8 are cut separately to produce rectangular test pieces (samples) with a length of 30 mm and a width of 10 mm. The two ends of the test piece are clamped with chucks so that the distance between the chucks is 20 mm. A tensile test is performed at room temperature (23°C ± 2°C) and a tensile speed of 30 mm / min to obtain a stress-strain curve. Based on the obtained stress-strain curve, the slope of the curve at two points of strain of 0.05% and 0.25% is obtained, and the tensile modulus at room temperature (23°C ± 2°C) is calculated. When the value of the covering members 1 to 8 when the strain (unit: %) is 0.05% is set to ε1, the value when the strain is 0.25% is set to ε2, and the stresses (unit: MPa) corresponding to ε1 and ε2 are set to σ1 and σ2 respectively, the tensile modulus E (unit: MPa) at room temperature (23°C±2°C) is calculated by dividing the difference in stress (σ2-σ1) by the difference in strain (ε2-ε1) as shown in the following formula (1).

[0170] E=(σ2-σ1) / (ε2ーε1)···(1)

[0171] (3) Relative dielectric constant

[0172] The covering members 1 to 8 were cut to produce circular test pieces (samples) with a diameter of 38 mm. The electrostatic capacitance (capacitance) C of the test piece was measured using an impedance analyzer, and the relative dielectric constant ε / ε0 was calculated from the measured electrostatic capacitance C. Specifically, the value C×d obtained by multiplying the electrostatic capacitance C of the test piece by the diameter d of the test piece was divided by the area S of the test piece and the dielectric constant ε0 of a vacuum (≒8.85×10 -12 F / m) squared (C×d / (S×ε0 2)). Thus, the relative dielectric constants (ε / ε0) of the covering members 1 to 8 were calculated. The relative dielectric constant of the test piece has a property of being dependent on the frequency. Since the frequency of the electrocardiogram is mainly several Hz to 30 Hz, the relative dielectric constant at 5 Hz was calculated.

[0173] (4) Charge

[0174] The charge amounts of the covering members 1 to 8 were measured using an electrostatic meter (YC-102, manufactured by AZWAN Corporation) at an ambient temperature of 23° C.±2° C. and an ambient humidity of 40%.

[0175] (5) Adhesion

[0176] According to JIS Z 0237:2000, the adhesion of covering members 1 to 8 to the adhesive was measured. First, covering members 1 to 8 were cut into a size of 10 mm in width and 100 mm in length to produce a sample piece. One side of the sample piece was pasted on a PET film (thickness 50 μm) to which an adhesive material was pasted, and the sample was crimped under a crimping condition in which a 2 kg roller was reciprocated once to produce a measurement sample. The adhesive material used was a double-sided adhesive tape having an adhesive layer formed of a silicone resin (ST503, manufactured by Nitto Denko Corporation) or a double-sided adhesive tape having an adhesive layer formed of an acrylic resin (PKE-20, manufactured by Nitto Denko Corporation). After the test piece was crimped to the PET film, it was aged for 30 minutes in an atmosphere of 23°C and 50% RH. After aging, the sample was peeled from the PET film at a tensile speed of 300 mm / min and a peel angle of 180° in an atmosphere of 25°C and 50% RH in accordance with JIS Z 0237, and the 180° peel adhesion (unit: N / 10 mm) was measured.

[0177] [Production of biosensors]

[0178] (Preparation of the first layer laminate)

[0179] A double-sided adhesive tape (manufactured by Nitto Denko Corporation, thickness: 60 μm) was pasted on the bottom of a rectangular porous substrate 1 (polyolefin foam sheet ("FOLEC (registered trademark)", manufactured by INOACCORPORATION Co., Ltd., thickness: 0.5 mm)) to form a first adhesive layer. The double-sided adhesive tape is a double-sided adhesive tape having an adhesive (acrylic resin) formed on its surface. Then, a silicone tape ("ST503 (HC) 60", manufactured by Nitto Denko Corporation, thickness: 60 μm) was pasted on the adhesive layer to form an upper adhesive layer, thereby producing a first layer component, the first layer laminate.

[0180] (Production of the second layer laminate)

[0181] Adhesives ("permeroll", manufactured by Nitto Denko Corporation) were attached to both sides of a rectangular substrate (PET ("PET-50-SCA1 (white)", manufactured by Mitsui & Co., Ltd.), thickness: 38 μm). Moisture permeability: 21 g / (m 2 ·day)), a lower adhesive layer and a second adhesive layer are formed to produce a second layer laminate as a second layer member.

[0182] (Production of Biosensors)

[0183] A sensor unit having a battery and a control unit is provided in the central portion of the upper surface of the second laminate. Then, a pair of electrodes are attached to the adhesive surface side of the first adhesive layer in a state of being sandwiched between the first adhesive layer of the first laminate and the second laminate, and the electrodes are connected to the wiring of the sensor unit. Then, the cover member 1 is laminated on the first laminate so that the sensor unit is arranged in the receiving space formed by the first laminate and the cover member 1, and a biological sensor is manufactured.

[0184] <Example 2, Comparative Examples 1 to 6>

[0185] In Example 1, except that changes were made as shown in Table 1, a biological sensor was produced in the same manner as in Example 1.

[0186] <Evaluation of biosensor characteristics>

[0187] The waveform accuracy and adhesion of the biosensors of the respective examples and comparative examples were measured and evaluated.

[0188] [Waveform accuracy]

[0189] The obtained biosensor was attached to the subject's skin for 24 hours, and the electrocardiogram was measured to obtain the electrocardiogram waveform. Figure 5 As shown in the figure, the P wave, QRS wave and T wave appear, and the interval (RRI) between the highest point R of the QRS wave and the highest point R of the next adjacent QRS wave is obtained. The obtained electrocardiogram waveform is used to obtain the RRI determination coefficient R 2 , based on the following evaluation criteria. RRI determination coefficient R 2 A scatter diagram is created with the nth and (n+1)th RRI plotted. For this scatter diagram, the coefficient of determination when the straight line is approximated is given. 2 When the value is 0.9 or more, there is almost no noise, and the waveform accuracy is evaluated as excellent (expressed as A in Table 1). 2When the RRI determination coefficient R is greater than 0.7 and less than 0.9, there is slight noise, but the R wave can be detected and the waveform accuracy is evaluated as good (expressed as B in Table 1). 2 When it is 0.5 or more and less than 0.7, there is a large noise, and it is difficult to detect the R wave, which is evaluated as poor waveform accuracy (expressed as C in Table 1).

[0190] (Evaluation Criteria)

[0191] A: RRI determination coefficient R 2 It is above 0.9.

[0192] B: RRI determination coefficient R 2 It is 0.7 or more and less than 0.9.

[0193] C: RRI determination coefficient R 2 It is 0.5 or more and less than 0.7.

[0194] [Adhesion]

[0195] The biosensor's adhesiveness was evaluated based on the following evaluation criteria when the biosensor was attached to a subject for 24 hours and an electrocardiogram was measured.

[0196] (Evaluation Criteria)

[0197] A: The biosensor remains attached to the subject's skin.

[0198] B: At least a portion of the biosensor is peeled off from the subject's skin.

[0199] [Table 1]

[0200]

[0201] Table 1 shows that the waveform accuracy and adhesion of the biosensors in Examples 1 and 2 satisfy the use conditions. In contrast, it is shown that at least one of the waveform accuracy and adhesion of the biosensors in Comparative Examples 1 to 6 does not satisfy the use conditions.

[0202] Therefore, if the tensile modulus and relative dielectric constant of the covering member of the biosensor of each embodiment described above are set to be less than the respective predetermined values, the noise generated by the electrocardiogram can be suppressed during the measurement of the electrocardiogram to stably obtain the electrocardiogram waveform, and the biosensor can be stably attached to the skin of the subject to maintain the adhesiveness. Therefore, it can be said that even if the biosensor involved in this embodiment is attached to the skin of the subject for a long time (for example, 24 hours), it can be effectively used to measure the electrocardiogram continuously for a long time.

[0203] In addition, the embodiments of the present invention are as follows, for example.

[0204] <1> A biosensor comprising: a sensor body for acquiring biometric information;

[0205] An electrode connected to the sensor body,

[0206] The electrode is disposed below, and a first layer member includes a cover member having a storage space for storing the sensor body, and

[0207] A second layer member is attached to the lower surface of the first layer member so as to expose the electrode and cover the sensor body.

[0208] The covering member has a tensile elastic modulus of 1.5 MPa or less and a relative dielectric constant of 2.2 or less.

[0209] <2> The biosensor according to <1>, wherein the cover member includes a thermoplastic elastomer.

[0210] <3> The biosensor according to <2>, wherein the thermoplastic elastomer is a styrene-based thermoplastic elastomer.

[0211] <4> The biosensor according to any one of <1> to <3>, wherein the first layer member comprises:

[0212] a first substrate having a through hole at a position corresponding to the storage space;

[0213] A first adhesive layer having the electrode attached thereto is provided on the surface of the first substrate on the biological body side, and

[0214] An upper adhesive layer is used to adhere the cover member and the first substrate.

[0215] <5> The biosensor according to any one of <1> to <4>, wherein the second layer member has a second adhesive layer on a surface opposite to the first layer member.

[0216] <6> The biosensor according to any one of <1> to <5>, wherein an adhesive surface for a living body is formed by the first layer member, the electrode, and the second layer member.

[0217] This application claims the priority based on Japanese Patent Application No. 2022-102032 filed with the Japan Patent Office on June 24, 2022, and cites all the contents described in the above application.

[0218] Explanation of symbols

[0219] 1 Biosensor

[0220] 2 Skin

[0221] 101st layer components

[0222] 11 Covering components

[0223] 12 Upper piece

[0224] 12a, 121a, 122a through holes

[0225] 20, 20A, 20B electrodes

[0226] 201A, 201B opposing parts

[0227] 202A, 202B exposed part

[0228] 30 Sensor unit

[0229] 31 Flexible Substrate

[0230] 32 Sensor body

[0231] 33A Connection

[0232] 33A, 33B connection part

[0233] 34 batteries

[0234] 40 Layer 2 Components

[0235] 41 2nd base material

[0236] 42 Adhesive layer for the lower part

[0237] 43 Second adhesive layer

[0238] 111 Protrusion

[0239] 111a Pit

[0240] 112A, 112B flat part

[0241] 121 No.1 Base Material

[0242] 1221st adhesive layer

[0243] 123 Adhesive layer for upper part

[0244] 321 Component mounting unit

[0245] 322 Battery Installation Department

[0246] 331A, 331B wiring

[0247] 332A, 332B terminal part

Claims

1. A biosensor comprising: The sensor body that acquires biological information, an electrode connected to the sensor body, The electrode is disposed below, and a first layer member includes a cover member having a storage space for storing the sensor body, and a second layer member attached to the lower surface of the first layer member so as to expose the electrode and cover the sensor body; The covering member has a tensile elastic modulus of 1.5 MPa or less and a relative dielectric constant of 2.2 or less.

2. The biosensor according to claim 1, The covering member includes a thermoplastic elastomer.

3. The biosensor according to claim 2, The thermoplastic elastomer is a styrene-based thermoplastic elastomer.

4. The biosensor according to claim 1, The first layer component comprises: a first substrate having a through hole at a position corresponding to the storage space, a first adhesive layer having the electrode attached thereto and disposed on the surface of the first substrate on the biological body side; and An upper adhesive layer for bonding the cover member and the first base material.

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

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

Images