Biological sensor

Abstract

The biological sensor according to the present invention is a biological sensor that is affixed to a living body, and is provided with: a sensor main body that acquires biological information; an electrode that is connected to the sensor main body; a first layer member that has a housing section that forms a housing space for housing the sensor main body and that has the electrode 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 body, the second layer member being provided between the first layer member and the second layer member so as to overlap a part of the electrode. At least a portion of a connection portion connecting the electrode and the sensor main body is provided so as to be disposed in the housing portion in plan view of the biological sensor.

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, a first adhesive layer is provided on the surface of the first layer component facing the biosensor, and a second adhesive layer is provided on the surface of the second layer component facing the biosensor. The first adhesive layer and the second adhesive layer are adhered to the skin, and biosensor information is obtained by using electrodes adhered to the first adhesive layer in a state of being exposed from the second layer component.

[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, previous biosensors such as the biosensor of Patent Document 1 are often attached to the biological surface of the subject such as the skin and used for a long time. Therefore, it is important for the biosensor to maintain the state of being attached to the skin of the subject without the subject feeling any discomfort such as itching or pain.

[0010] An object of one aspect of the present invention is to provide a biosensor that can reduce discomfort to a subject during use and can be stably attached to the subject.

[0011] Methods for solving problems

[0012] One embodiment of a biosensor according to the present invention is a biosensor to be attached to a living body, comprising:

[0013] The sensor body that acquires biological information,

[0014] An electrode connected to the sensor body,

[0015] The electrode is disposed below, and a first layer member has a housing portion forming a housing space for housing the sensor body, and

[0016] 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.

[0017] The first layer member and the second layer member are arranged to overlap a portion of the electrode, and at least a portion of a connection portion connecting the electrode to the sensor body is arranged in the housing portion when the biosensor is viewed from above.

[0018] Effects of the Invention

[0019] One aspect of the biosensor according to the present invention can be stably attached to a subject while reducing discomfort caused to the subject during use. BRIEF DESCRIPTION OF THE DRAWINGS

[0020] Figure 1 It is a perspective view showing the overall structure of a biosensor according to an embodiment of the present invention.

[0021] Figure 2 It is a plan view showing an example of each component of the biosensor.

[0022] Figure 3 is the cross-sectional view of the biosensor in the length direction, Figure 1 II cross-sectional view.

[0023] Figure 4 for Figure 1 Plan view of the biosensor.

[0024] Figure 5 To express that Figure 1 An explanatory diagram showing a state in which a biosensor is attached to the chest of a living body.

[0025] Figure 6 It is a graph showing the test results of the pressure of Example 1 and Comparative Example 1. 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 according to 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 have focused on the positions of the connection parts 33A and 33B provided on the upper surface of the second layer member 40 for connecting the sensor body 32 of the sensor part 30 and the electrode 20 when the biosensor 1 is used, when viewed from above. The inventors of the present application have found that if the connection parts 33A and 33B are provided at highly flexible positions such as the flat parts 112A and 112B of the cover member 11 when viewed from above, when the biosensor 1 is attached to the skin 2, the connection parts 33A and 33B may press the skin 2 with the body movement of the skin 2, causing discomfort such as itching or pain to the subject. Therefore, the inventors of the present application have found that if part or all of the connection parts 33A and 33B are provided at a hard portion such as the receiving portion of the cover member 11 when viewed from above, the biosensor 1 can be attached to the skin 2 of the subject while reducing discomfort such as itching or pain to the subject.

[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 1 The housing portion 111 protrudes in a substantially hemispherical shape in the height direction (+Z axial direction) of the cover member 11, and flat portions 112A and 112B are provided at both end sides in the longitudinal direction (Y axial direction) of the cover member 11.

[0039] The receiving portion 111 has an opening formed so as to have a concave pit 111a formed on the skin 2 side on its inner side (sticking side). The pit 111a only needs to form at least a part of the receiving space S, and at least a part of the sensor portion 30 can be received. On the inner side (sticking side) of the receiving portion 111, the receiving space S for receiving the sensor portion 30 is formed by the pit 111a on the inner surface of the receiving portion 111, the electrode 20 and the second layer member 40.

[0040] The central portion of the receiving portion 111 in the longitudinal direction (Y-axis direction) has a Figure 1 The structure includes a protruding portion 111A that protrudes in the height direction (+Z axial direction), and an inclined portion 111B that is formed so as to be inclined from the protruding portion 111A toward the flat portions 112A and 112B.

[0041] The upper and lower surfaces of the protrusion 111A may be formed flat.

[0042] Inclined portion 111B includes inclined portion 111B-1 inclined from protruding portion 111A toward flat portion 112A, and inclined portion 111B-2 inclined from protruding portion 111A toward flat portion 112B. Inclined portion 111B-1 and inclined portion 111B-2 may have the same or different shapes and inclinations.

[0043] The inclined portion 111B is as follows Figure 4 As shown in FIG. 1 , the inclined portion 111B is formed above a position overlapping at least a portion of the connecting portions 33A and 33B when the biosensor 1 is viewed from above. In order to reduce the pressure applied by the connecting portions 33A and 33B to the skin 2, the inclined portion 111B is preferably formed so as to include all of the connecting portions 33A and 33B when the biosensor 1 is viewed from above.

[0044] The flat portions 112A and 112B are provided at both end sides of the housing portion 111 and are formed integrally with the housing portion 111. The upper and lower surfaces of the flat portions 112A and 112B are formed flatly similarly to the housing portion 111.

[0045] As described later, the housing portion 111 is formed so that the thickness of the housing portion 111 is thicker than the thickness of the flat portions 112A and 112B, and preferably has a higher bending rigidity than the flat portions 112A and 112B which are portions other than the housing portion 111 of the cover member 11. In addition, in the housing portion 111, the protruding portion 111A or the inclined portion 111B may be formed so as to have a higher bending rigidity than the flat portions 112A and 112B.

[0046] In general, the covering member 11 can be formed using a flexible material such as a cross-linked rubber. As the cross-linked rubber, for example, silicone rubber, fluororubber, urethane rubber, natural rubber, acrylic rubber, butadiene rubber, isoprene rubber, styrene-butadiene copolymer rubber, nitrile rubber, hydrogenated nitrile rubber, chloroprene rubber, ethylene-propylene copolymer rubber, chlorinated polyethylene rubber, chlorosulfonated polyethylene rubber, butyl rubber and halogenated butyl rubber can be cited. In addition, the covering member 11 can be formed by stacking the above-mentioned flexible material on the surface of the support using a base resin such as polyethylene terephthalate (PET) as a support. By forming the covering member 11 using the above-mentioned flexible material, the sensor portion 30 configured in the storage space S of the covering member 11 is protected, and the impact applied to the biosensor 1 from the upper side is absorbed and the impact applied to the sensor portion 30 is mitigated.

[0047] The thickness of the top and side walls of the protrusion 111A may be thicker than the thickness of the flat portions 112A and 112B. This can reduce the flexibility of the protrusion 111A 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.

[0048] The thickness of the top surface and side walls of the protruding portion 111A can be appropriately designed, and can be, for example, 1.5 mm to 3.0 mm. The thickness of the flat portions 112A and 112B can also be appropriately designed, and can be, for example, 0.5 mm to 1.0 mm.

[0049] The thin flat portions 112A and 112B are more flexible than the protruding portion 111A, 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.

[0050] The outer periphery of the flat portions 112A and 112B may have a shape in which the thickness gradually decreases toward the ends. This can further improve the flexibility of the outer periphery of the flat portions 112A and 112B, and can improve the sense of installation when the biosensor 1 is attached to the skin 2, compared with the case where the thickness of the outer periphery of the flat portions 112A and 112B is not reduced. In addition, as described later, when the surface of the skin 2 is deformed, the stress applied to the flat portions 112A and 112B can be reduced.

[0051] The hardness of the covering member 11 can be designed to be any appropriate size, for example, it can be 40 to 70. 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 value measured in accordance with ISO7619 (JIS K 6253-3: 2012). Shore A hardness is a type A durometer hardness measured by a rubber durometer (type A durometer) with an A-type (cylindrical) indenter.

[0052] (Upper piece)

[0053] 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 protruding portion 111A 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 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.

[0054] 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 .

[0055] ((First base material))

[0056] 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 may have flexibility, water resistance, and moisture permeability. The first substrate 121 has flexibility, water resistance, and moisture permeability, so that the first substrate 121 is easily extended in a state of contact with the skin 2, and can maintain a state of contact with the skin 2, and can suppress the intrusion of liquid into the gap between the first substrate 121 and the upper adhesive layer 123. In addition, water vapor brought by sweat generated by the skin 2 can be released to the outside of the biosensor 1 through the first substrate 121. Therefore, the upper sheet 12 is easy to maintain adhesion durability.

[0057] The first substrate 121 may be a non-porous body without a porous structure or a porous body with a porous structure as long as it has flexibility, waterproofness, and moisture permeability. If the first substrate 121 is a non-porous body, it is easy to maintain the thin film and strength of the first substrate 121, so it is preferred. If the first substrate 121 is a porous body, it is easy to release water vapor brought by sweat or the like generated by the skin 2 to which the biosensor 1 is attached to the biosensor 1 through the first substrate 121 to the outside of the biosensor 1, so it is preferred.

[0058] As the non-porous body, a molded body formed in a sheet shape can be used.

[0059] As a porous body, it is possible to have a bubble structure of continuous bubbles, independent bubbles, semi-independent bubbles, etc. That is, the porous body can be a porous body manufactured by foaming to form connected bubbles (a porous body having a connected bubble structure), a porous body manufactured by foaming to form independent bubbles (a porous body having an independent bubble structure), or a porous body manufactured by foaming to form semi-independent bubbles (a porous body having a semi-independent bubble structure). As a porous body, for example, a foam sheet, a nonwoven fabric sheet, etc. can be used.

[0060] As a material forming the first substrate 121, for example, a flexible material such as a thermoplastic resin such as a polyurethane resin, a polystyrene resin, a polyolefin resin, a silicone resin, an acrylic resin, a vinyl chloride resin, or a polyester resin, or a thermoplastic elastomer can be used.

[0061] As thermoplastic elastomer, polyurethane thermoplastic elastomer, polystyrene thermoplastic elastomer, polyolefin thermoplastic elastomer, polyester thermoplastic elastomer, polyvinyl chloride thermoplastic elastomer, polyamide thermoplastic elastomer, nitrile thermoplastic elastomer, nylon thermoplastic elastomer, fluororubber thermoplastic elastomer, polybutadiene thermoplastic elastomer, ethylene vinyl acetate thermoplastic elastomer, chlorinated polyethylene thermoplastic elastomer, styrene-butadiene block copolymer or its hydride, styrene-isoprene block copolymer or its hydride etc. can be enumerated. They can be used alone or in combination of two or more. Among these, polyurethane thermoplastic elastomer is preferred.

[0062] When the first substrate 121 is a non-porous body, specifically, a polyurethane sheet such as S-URS manufactured by Nippon Matai can be used.

[0063] When the first substrate 121 is a porous body, specifically, a foam sheet such as FOLEC manufactured by INOAC CORPORATION, a nonwoven fabric sheet such as medical adhesive base cloth EW manufactured by Nippon Vilene, etc. can be used.

[0064] The first base material 121 may be set to have higher elasticity than the covering member 11 .

[0065] The moisture permeability of the first substrate 121 may be higher than that of the cover member 11. The moisture permeability of the first substrate 121 is preferably 100 g / (m 2 ·day)~5000g / (m 2 ·day). The moisture permeability of the first substrate 121 is set 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] The thickness of the first substrate 121 can be appropriately set according to the type of the first substrate 121, etc., and is preferably thicker than the thickness of the outer periphery of the cover member 11. If the thickness of the first substrate 121 is thicker than the thickness of the outer periphery of the cover member 11, it is possible to reduce the irritation caused by the outer periphery of the cover member 11 contacting the skin 2. The thickness of the first substrate 121 is preferably, for example, 10 μm to 1.5 mm, and more preferably 0.7 mm to 1.0 mm.

[0067] When the first substrate 121 is formed of a porous body such as a foam sheet or a nonwoven fabric sheet, the thickness of the first substrate 121 is, for example, preferably 0.5 mm to 1.5 mm, more preferably about 1 mm.

[0068] When the first substrate 121 is formed of a non-porous body such as a polyurethane sheet, the thickness of the first substrate 121 is, for example, preferably 10 μm to 300 μm, and more preferably about 30 μm.

[0069] The first base material 121 has a through hole 121a at a position facing the protruding portion 111A 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.

[0070] ((First adhesive layer))

[0071] 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.

[0072] 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.

[0073] 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.

[0074] As the material forming the first adhesive layer 122, a material having pressure-sensitive adhesiveness can be used. As the material having pressure-sensitive adhesiveness, for example, acrylic adhesives, silicone adhesives, etc. can be used, and acrylic adhesives are preferably used. As acrylic adhesives, for example, acrylic polymers described in Japanese Patent Publication No. 2002-65841 can be cited.

[0075] The first adhesive layer 122 may be an adhesive tape formed of the above-mentioned materials.

[0076] 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 skin 2 and the portion where it is difficult to contact with the skin 2 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 where the surface of the first adhesive layer 122 is easy to contact with the skin 2 can be located. The moisture permeability of the first adhesive layer 122 tends to be higher the thinner the adhesive is. Therefore, the first adhesive layer 122 forms a reticular pattern on its surface, and has a portion where the thickness of the adhesive is thin, so that compared with the case where the reticular pattern is not formed, it is possible to maintain the adhesive force while improving the moisture permeability. In addition, the shape of the concave portion may be a linear shape or a circular shape other than a wave shape.

[0077] The thickness of the first adhesive layer 122 can be set appropriately and arbitrarily, and can be, for example, 10 μm to 300 μm. If the thickness of the first adhesive layer 122 is 10 μm to 300 μm, the biosensor 1 can be made thinner.

[0078] The adhesive force of the first adhesive layer 122 can be set appropriately and arbitrarily. For example, with respect to the phenolic resin plate, it is preferably 3.0N / 10mm to 20N / 10mm, more preferably 4.0N / 10mm to 15N / 10mm, and further preferably 5.0N / 10mm to 10N / 10mm. If the adhesive force of the first adhesive layer 122 is 3.0N / 10mm to 20N / 10mm, the first adhesive layer 122 constitutes a part of the adhesive surface of the biosensor 1 to the surface of the skin 2, thereby achieving improved adhesion of the biosensor 1 to the living body.

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

[0080] Figure 3As 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] A biocompatible material is used as a material for forming the upper adhesive layer 123. As the biocompatible material, for example, an acrylic adhesive, a silicone adhesive, a silicone tape, etc. can be used, and a silicone adhesive is preferably used.

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

[0083] [electrode]

[0084] Figure 3 As 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] Electrode 20 Figure 4 As shown in the figure, it is provided so as to be located below the region including the connection parts 33A and 33B when the biosensor 1 is viewed from above.

[0086] 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.

[0087] 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.

[0088] The electrode 20 may have any shape such as a sheet.

[0089] 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.

[0090] Electrodes 20A and 20B are as follows Figure 2 and Figure 3 As 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.

[0091] 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 formed using an electrode sheet formed of a cured product of the conductive composition in a sheet shape.

[0092] As conductive polymers, for example, polythiophene conductive polymers, polyaniline conductive polymers, polyacetylene conductive polymers, polypyrrole conductive polymers, polyphenylene conductive polymers and derivatives thereof, and complexes thereof, etc. can be used. These can be used alone or in combination of two or more. Among these, it is preferred to use a complex in which polythiophene is doped with polyaniline as a dopant. Among the complexes of polythiophene and polyaniline, from the perspective of lower contact impedance with a biological body and high conductivity, it is more preferred to use 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.

[0093] 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.

[0094] 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.

[0095] As the metal and the alloy, general metals and alloys such as Au, Pt, Ag, Cu, and Al can be used.

[0096] The thickness of the electrode 20 can be set to any appropriate height, for example, 10 μm to 100 μm. If the thickness of the electrode 20 is within the above preferred range, the electrode 20 can have sufficient strength and flexibility, and conductive stability during deformation.

[0097] 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.

[0098] The area of ​​the electrode 20 can be set to any appropriate size according to the size of the biosensor 1, for example, 2.0 cm 2 ~5.0cm 2 If the area of ​​electrode 20 is 2.0 cm 2 ~5.0cm 2 , the electrode 20 can have sufficient conductive stability. In addition, the method for measuring the area of ​​the electrode 20 is not particularly limited, and a general measurement method such as calculation from a plan view image of the electrode can be used.

[0099] (Sensor part)

[0100] Figure 2 As shown, the sensor section 30 includes a flexible substrate 31 , a sensor body 32 , and connection sections 33A and 33B connected to the sensor body 32 .

[0101] The flexible substrate 31 is a resin substrate on which various components for acquiring biological information are mounted, and the flexible substrate 31 is provided with a sensor body 32 and connection parts 33A and 33B.

[0102] The sensor body 32 includes a component mounting portion 321 and a battery mounting portion 322 as a control portion, and acquires biological information.

[0103] 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 to obtain 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.

[0104] 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.

[0105] 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.

[0106] 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.

[0107] 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.

[0108] 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 .

[0109] The connecting parts 33A and 33B are as follows Figure 4 As shown in FIG. 1 , the inclined portion 111B is formed below the inclined portion 111B when the biosensor 1 is viewed from above.

[0110] 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.

[0111] [Layer 2 components]

[0112] 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 .

[0113] 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.

[0114] (Second base material)

[0115] 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, imide-modified polystyrene, acrylonitrile-butadiene-styrene (ABS) resin, imide-modified ABS resin, styrene-acrylonitrile copolymer (SAN) resin, acrylonitrile-ethylene-propylene-diene-styrene (AES) resin, and the like; polyimide resin; polyurethane resin; silicone resin; polyvinyl chloride, ethylene-vinyl acetate copolymer resin, and the like; and thermoplastic resins. 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.

[0116] 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 .

[0117] The thickness of the second substrate 41 can be appropriately and arbitrarily selected, and can be, for example, 1 μm to 300 μm.

[0118] (Adhesive layer at the bottom)

[0119] 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.

[0120] (Second adhesive layer)

[0121] 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.

[0122] 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.

[0123] 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.

[0124] 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.

[0125] 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.

[0126] 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.

[0127] 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.

[0128] 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.

[0129] 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.

[0130] 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.

[0131] 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.

[0132] 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.

[0133] 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.

[0134] 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.

[0135] Figure 5 To express that Figure 1 1 is an explanatory diagram showing a state where the biosensor 1 is attached to the chest of a subject P. Figure 5 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.

[0136] Thus, the biosensor 1 includes the first layer member 10, the electrode 20, the sensor body 32, and the second layer member 40, and is arranged so that almost all of the connecting portions 33A and 33B are arranged in the housing portion 111 when the biosensor 1 is viewed from above. The housing portion 111 is arranged so that almost all of its area is located below the inclined portion 111B of the housing portion 111. The housing portion 111 is formed thicker than the flat portions 112A and 112B, and thus has a higher bending rigidity than the flat portions 112A and 112B. Therefore, the covering member 11 is difficult to deform, and the connecting portions 33A and 33B are difficult to press the second layer member 40, thereby reducing the connection portions 33A and 33B from pressing the skin 2 through the second layer member 40 to stimulate the skin 2 during the attachment of the biosensor 1 to the skin 2 of the subject. Thus, the biosensor 1 can maintain the state of being attached to the skin 2 while reducing the discomfort such as itching and pain caused by the connection parts 33A and 33B irritating the skin 2 through the second layer member 40. Thus, the biosensor 1 can be stably attached to the subject while reducing the discomfort caused to the subject during use.

[0137] In addition, the degree of pressing of the adhesive surface of the biosensor 1 against the skin 2 can be evaluated using any appropriate method. For example, the first layer member 10 and the second layer member 40 of the biosensor 1 are brought into contact with a pressure-sensitive paper fixed on a simulated skin having the same elasticity as the skin 2, and the biosensor 1 is attached to the pressure-sensitive paper. The simulated skin can be a biomask in which the surface of a urethane elastomer film is processed to reproduce the hydrophilicity and surface wrinkles close to those of human skin. The biosensor 1 and the simulated skin are bent with a strain of a predetermined magnitude (for example, 10%) in a direction roughly parallel to the width direction of the biosensor 1, and left to stand for a predetermined time (for example, 5 minutes). Then, the biosensor 1 is peeled off from the pressure-sensitive paper, the pressure-sensitive paper is recovered from the simulated skin, and the recovered pressure-sensitive paper is read by a scanner to form an image. The pressed part of the pressure-sensitive paper changes color from white to red, and the red color becomes darker according to the pressure. First, using data indicating the relationship between color density and pressure, it is possible to calculate the pressure of the attachment surface of the biological sensor 1 on the skin 2 from the image processed image.

[0138] The biosensor 1 can form the housing portion 111 in a hemispherical shape. Thus, the area of ​​the inclined portion 111B can be reliably provided in the housing portion 111 when the biosensor 1 is viewed from above, and the connecting portions 33A and 33B can be reliably provided so as to be located below the inclined portion 111B of the housing portion 111 when the biosensor 1 is viewed from above. Thus, the biosensor 1 can more reliably reduce discomfort to the subject during use.

[0139] The biosensor 1 can be provided with a protruding portion 111A and an inclined portion 111B in the housing portion 111, and most of the connecting portions 33A and 33B can be arranged in the inclined portion 111B when the biosensor 1 is viewed from above. The thicker the inclined portion 111B is than the flat portions 112A and 112B, the more reliably higher the bending rigidity is than the flat portions 112A and 112B. Therefore, while the biosensor 1 is attached to the skin 2 of the subject, it is possible to more reliably reduce the irritation of the skin 2 caused by the connecting portions 33A and 33B through the second layer member 40 due to body movement, etc., thereby further reducing the discomfort caused to the subject. As a result, the biosensor 1 can be stably attached to the subject while further reducing the discomfort caused to the subject during use.

[0140] The biosensor 1 can include a cover member 11, a first substrate 121, a first adhesive layer 122, and an upper adhesive layer 123 on the first layer member 10. The first adhesive layer 122 has adhesiveness, so the electrode 20 can contact the surface of the skin 2 in a state where it is 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 if 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 stably maintain the adhesion to the skin 2.

[0141] The biosensor 1 can have 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 reducing the contact impedance between the electrode 20 and the surface of the skin 2. Thus, the biosensor 1 can further improve the detection accuracy of the biological signal during use, and further stably maintain the adhesion to the skin 2.

[0142] 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.

[0143] 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.

[0144] 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.

[0145] Example

[0146] 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.

[0147] <Production of Biosensors>

[0148] [Example 1]

[0149] (Production of Covering Member)

[0150] A coating layer of Shore A hardness of 40 made of silicone rubber was formed on a support made of PET as a base resin. Figure 1 As shown in the figure, the covering member is formed into a predetermined shape to produce the covering member. The covering member is formed in a roughly rectangular shape so that the front end has a roundness when viewed from above. The covering member is formed in a manner that a receiving portion protrudes toward the height direction in the central part in the longitudinal direction, and a thin flat portion on the front end side of the receiving portion in the long axis direction. The receiving portion is formed in a manner that a protrusion protrudes toward the height direction in the central part in the longitudinal direction, and an inclined portion is formed so that the protrusion is inclined toward the flat portion side located on the two front end sides.

[0151] (Preparation of the first layer laminate)

[0152] An acrylic skin adhesive (thickness: 60 μm) was attached as a first adhesive layer to the bottom of a polyurethane sheet (S-URS, manufactured by Japan Matai Co., Ltd., thickness: 30 μm) formed in a rectangular shape with rounded ends as a first substrate. Then, a silicone adhesive (thickness: 60 μm) was attached as an upper adhesive layer to the top of the polyurethane sheet to prepare an upper sheet.

[0153] (Electrode Preparation)

[0154] 1. Preparation of Conductive Composition

[0155] 0.38 parts by mass of PEDOT / PSS particles (Orgacon DRY, manufactured by AGFA Materials, Japan) as a conductive polymer, 10.00 parts by mass of an aqueous solution containing modified polyvinyl alcohol (modified PVA) as a binder resin (modified polyvinyl alcohol concentration: 10%, gohsenx Z-410, manufactured by Nippon Synthetic Chemical Co., Ltd.), 2.00 parts by mass of glycerol (manufactured by Wako Pure Chemical Industries, Ltd.) as a plasticizer, 1.60 parts by mass of 2-propylene glycol as a solvent, and 6.50 parts by mass of water were added to an ultrasonic bath. The aqueous solution containing these components was mixed in an ultrasonic bath for 30 minutes to prepare a uniform conductive composition aqueous solution A.

[0156] The concentration of the modified PVA in the aqueous solution containing the modified PVA was about 10%, and thus the content of the modified PVA in the conductive composition aqueous solution A was 1.00 parts by mass.

[0157] The contents of the conductive polymer, the binder resin, and the plasticizer were 11.2 parts by mass, 29.6 parts by mass, and 59.2 parts by mass, respectively, relative to 100.0 parts by mass of the conductive composition.

[0158] 2. Preparation of electrode sheets

[0159] The prepared conductive composition aqueous solution A was coated on a polyethylene terephthalate (PET) film using an applicator. The PET film coated with the conductive composition aqueous solution A was then transported to a drying oven (SPHH-201, manufactured by ESPEC), and the conductive composition aqueous solution A was heated and dried at 135° C. for 3 minutes to produce a solidified conductive composition. The solidified material was punched (pressed) into a desired shape and formed into a sheet to produce an electrode sheet (biological electrode) with a thickness of 20 μm.

[0160] The contents of the conductive polymer, binder resin, and plasticizer contained in the electrode sheet were 11.2 parts by mass, 29.6 parts by mass, and 59.2 parts by mass, respectively, similar to those in the conductive composition.

[0161] (Production of the second layer laminate)

[0162] An acrylic skin adhesive (thickness: 40 μm) was attached to both surfaces of a second substrate (ethylene vinyl acetate (EVA) film, thickness: 80 μm) formed in a rectangular shape to form a lower adhesive layer and a second adhesive layer to produce a second laminated sheet.

[0163] (Production of Biosensors)

[0164] A sensor unit having a battery and a control unit is provided at the center 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 sensor unit is arranged in a receiving space formed by the first laminate and the covering member, and the covering member is stacked on the first laminate in a manner that the connecting portion is located in a position substantially accommodated in the inclined portion of the covering member when the biosensor is viewed from above, thereby manufacturing the biosensor.

[0165] [Comparative Example 1]

[0166] In Example 1, a biological sensor was produced in the same manner as in Example 1 except that the arrangement was changed so that the connection portion was located so as to protrude from the inclined portion of the cover member.

[0167] <Evaluation of the adhesion feeling of biosensors>

[0168] A pressure-sensitive paper is placed on a simulated skin having the same elasticity as the skin, and after the pressure-sensitive paper is fixed to the simulated skin at two locations at both ends, the first adhesive layer and the second adhesive layer of the biosensor are brought into contact with the pressure-sensitive paper to paste the biosensor on the pressure-sensitive paper. The simulated skin used for evaluation uses a biomask (No.: P001-001, manufactured by BURAKU Co., Ltd.) in which the surface of a urethane elastomer film is processed to reproduce the hydrophilicity and hydrophobicity of human skin and the wrinkles on the surface. The simulated skin to which the biosensor and the pressure-sensitive paper are pasted is bent with a strain of 10% approximately parallel to the width direction of the biosensor, and left to stand in this state for 5 minutes. Then, the biosensor is peeled off from the pressure-sensitive paper, and the pressure-sensitive paper is recovered from the simulated skin. The recovered pressure-sensitive paper is read using a scanner and imaged. The pressurized part of the pressure-sensitive paper changes color from white to red, and the red color becomes darker according to the pressure. Using data indicating the relationship between the concentration of color and pressure in advance, the pressure of the connection part is calculated from the image processed. The calculation result of the pressure is shown in Figure 6 .

[0169] Figure 6 As shown in the figure, in Example 1, the pressure applied by the connection part to the simulated skin is about 0.4 MPa, and in Comparative Example 1, the pressure applied by the connection part to the simulated skin is about 1.1 MPa. Therefore, it can be said that if the position of the connection part of the biosensor of the above embodiment is set at a predetermined position of the covering member, the pressure applied to the surface of the biological body can be reduced, and even if it is attached to the skin of the subject for a long time (for example, 24 hours), it can be effectively used to reduce the discomfort caused to the subject while continuously measuring the electrocardiogram for a long time.

[0170] In addition, the embodiments of the present invention are as follows, for example.

[0171] <1> A biosensor that is attached to a living body, comprising:

[0172] The sensor body that acquires biological information,

[0173] An electrode connected to the sensor body,

[0174] The electrode is disposed below, and a first layer member has a housing portion forming a housing space for housing the sensor body, and

[0175] 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.

[0176] The first layer member and the second layer member are arranged to overlap a portion of the electrode, and at least a portion of a connection portion connecting the electrode to the sensor body is arranged in the housing portion when the biosensor is viewed from above.

[0177] <2> In the biosensor according to <1>, the housing portion has a higher bending rigidity than a portion of the first layer member other than the housing portion.

[0178] <3> The biosensor according to <1> or <2>, wherein the housing portion is formed in a hemispherical shape. <4> The biosensor according to <3>, wherein the housing portion has a protrusion protruding toward the opposite side of the biosensor at the center of the biosensor, and an inclined portion formed so as to be inclined from the protrusion toward both ends of the biosensor.

[0179] At least a portion of the connection portion is provided so as to be disposed within the inclined portion in a plan view of the biosensor.

[0180] <5> The biosensor according to any one of <1> to <4>, wherein the first layer member comprises:

[0181] a covering member having a storage space for storing the sensor body and an opening of the storage space,

[0182] a first base material provided on the opening side of the cover member and having a through hole at a position corresponding to the storage space;

[0183] a first adhesive layer having the electrode attached thereto and provided on a surface of the first substrate opposite to the cover member; and

[0184] An upper adhesive layer is used to adhere the cover member and the first substrate.

[0185] <6> The biosensor according to any one of <1> to <5>, wherein the second layer member has a second adhesive layer on a surface opposite to the first layer member.

[0186] <7> The biosensor according to any one of <1> to <6>, wherein an adhesive surface to a living body is formed by the electrode, the first layer member, and the second layer member.

[0187] This application claims the priority based on Japanese Patent Application No. 2022-103139 filed with the Japan Patent Office on June 28, 2022, and cites all the contents described in the above application.

[0188] Explanation of symbols

[0189] 1 Biosensor

[0190] 2 Skin

[0191] 101st layer components

[0192] 11 Covering components

[0193] 12 Upper piece

[0194] 12a, 121a, 122a through holes

[0195] 20, 20A, 20B electrodes

[0196] Opposing parts of 201A and 201B

[0197] 202A and 202B exposed parts

[0198] 30 Sensor unit

[0199] 31 Flexible Substrate

[0200] 32 Sensor body

[0201] 33A Connection

[0202] 33A, 33B connection part

[0203] 34 Batteries

[0204] 40 Layer 2 Components

[0205] 41 2nd base material

[0206] 42 Adhesive layer for the lower part

[0207] 43 Second adhesive layer

[0208] 111 Containment Department

[0209] 111A Protrusion

[0210] 111a Pit

[0211] 111B, 111B-1, 111B-2 inclined part

[0212] 112A, 112B flat part

[0213] 121 No.1 Base Material

[0214] 1221st adhesive layer

[0215] 123 Adhesive layer for upper part

[0216] 321 Component mounting unit

[0217] 322 Battery Installation Department

[0218] 331A, 331B wiring

[0219] 332A, 332B terminal part

Claims

1. A biosensor, which is a biosensor attached to a living body, comprising: The sensor body that acquires biological information, an electrode connected to the sensor body, The electrode is disposed below, and a first layer member has a housing portion forming a housing space for housing 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 first layer member and the second layer member are arranged to overlap a portion of the electrode, and at least a portion of a connection portion connecting the electrode to the sensor body is arranged in the housing portion when the biosensor is viewed from above.

2. The biosensor according to claim 1, The housing portion has a higher bending rigidity than a portion of the first layer member other than the housing portion.

3. The biosensor according to claim 1, The housing portion is formed in a hemispherical shape.

4. The biosensor according to claim 3, The housing portion has a protrusion protruding toward the opposite side of the living body at a central portion of the biosensor, and an inclined portion formed so as to be inclined from the protrusion toward both end sides of the biosensor. At least a portion of the connection portion is provided so as to be disposed within the inclined portion when the biosensor is viewed from above.

5. The biosensor according to claim 1, The first layer component comprises: a covering member having a housing space for housing the sensor body and an opening of the housing space, a first base material provided on the opening side of the cover member and having a through hole at a position corresponding to the storage space; a first adhesive layer having the electrode attached thereto and provided on a surface of the first substrate opposite to the cover member; and An upper adhesive layer for bonding the cover member and the first base material.

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

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

Images