Electrode device for living body

Abstract

The present disclosure provides a structure of an electrode sheet having a low resistance and: reduces noise attributed to moments of force by physically and electrically strengthening fixation and connection between skin, an electrode, and a sensor module; reduces manufacturing cost by allowing the use of a general printing method for forming a wiring member of the electrode sheet; and reduces a wearing sensation felt by a subject during attachment.　To this end, an electrode device for a living body according to the present disclosure comprises an electrode sheet including at least a pair of electrodes for receiving a bioelectrical signal, a wiring member for transmitting the received bioelectrical signal, a sensor module for outputting a signal related to the bioelectrical signal to the outside, and a connection member for connecting the transmitted bioelectrical signal to the sensor module. The connection member is inserted into a hole, formed in the wiring member, with a fit tolerance for "transition fit" or "tight fit". As the wiring member is slid upward along the side surface of the connection member, the wiring member and the connection member are placed in close contact with each other and fixed together.

Description

Biological electrode device

[0001] The present invention relates to a biological electrode device.

[0002] Currently, medicine has highly developed, and by analyzing body fluids such as a patient's blood, saliva, urine, etc., the patient's condition can be grasped. For example, research has been conducted on judging the presence or absence of dental caries by measuring the pH of saliva and diagnosing diabetes by measuring the blood glucose level in tears. These examinations are performed, for example, by the patient collecting their own body fluid and the medical institution measuring and analyzing it.

[0003] On the other hand, devices for the patient to measure and analyze their own body fluid without going to a medical institution have also been developed. This not only enables the acceleration of examinations and analyses but can also be used as a means to reduce medical costs in an aging society, as will be described below.

[0004] Generally, after self-recognizing poor physical condition, a patient visits a medical institution for a medical examination. However, at that stage, there may already be terminal symptoms. In this case, advanced medical treatment and administration of expensive drugs are carried out, resulting in an increase in the burden of medical expenses.

[0005] If poor physical condition, etc., can be detected early, there is a possibility of cure with mild treatment that does not require medication, etc., by reviewing lifestyle habits. Therefore, the number of institutions conducting regular medical examinations as preventive medicine sponsored by health insurance societies has been increasing.

[0006] However, since regular medical examinations are generally conducted about once or twice a year, a blank period occurs between examinations, and diseases that develop during this period cannot be recognized. Thus, there are limitations to current preventive medicine.

[0007] If a device that enables the patient to measure and analyze their own body fluid without going to a medical institution is used, examinations can be conducted at a high frequency. Therefore, it becomes possible to detect changes in physical condition before the patient becomes aware of them. Consequently, the need for advanced medical treatment and administration of expensive drugs is reduced, and medical costs can be cut.

[0008] One method for obtaining information about bodily fluids is to attach biosensors to the skin or mucous membranes to acquire information about the internal environment in vivo. While this method allows for the acquisition of biological information without time lag, it involves direct contact between the sensor and the body, which can have a significant impact on the body, thus requiring a highly reliable device.

[0009] While various biosensing techniques exist, electrochemical methods are widely used for applications such as blood glucose measurement because they can sensitively detect trace components. Electrochemical methods have the advantage of easily processing and analyzing signals obtained using semiconductor devices, as they detect biological information, which is typically a chemical property, as electrical signals. For this reason, the development of new electrochemical sensing devices and sensing techniques using them is actively pursued worldwide.

[0010] On the other hand, needle-like members, which have one or more tiny needle-like projections (e.g., microneedles) capable of puncturing the skin on a substrate, are attached to the epidermis of a living body to puncture the stratum corneum, the outermost layer of the skin, thereby administering pharmaceuticals to the body or aspirating and extracting blood from the body. Various sizes and shapes of needle-like members have been proposed, and they are expected to be a non-invasive method of administration and examination.

[0011] By using a needle-shaped component to puncture the epidermis, which is the layer beneath the stratum corneum, and further into the dermis, the tip of the needle-shaped component can reach these layers and act upon them. In addition to administering pharmaceuticals or aspirating blood from the body, it has also been proposed to use the needle-shaped component (or probe) as an electrode to apply an electrical signal and receive a response to obtain information about the subcutaneous layers, or to apply a voltage between electrodes to allow drugs to penetrate.

[0012] For example, the following Patent Documents 1 and 2 describe technologies related to biosensing devices using needle-shaped members.

[0013] Patent Document 1 discloses a medical device for diagnosing the condition of a subject's skin. This medical device comprises a conductive probe having multiple electrodes, each electrode comprising multiple microneedles. In this case, each electrode has a base substrate formed of a silicon substrate. The microneedles are formed integrally with the substrate, arranged with lateral spacing between them, and have sufficient length to penetrate the stratum corneum. The microneedles are configured to have at least a partially inclined shape. Furthermore, the invention described in Patent Document 1 relates to electrodes for this device, arrangement of microneedles, and a method for diagnosing a biological condition using impedance measurement. This diagnostic method is particularly relevant to skin cancer, preferably basal cell carcinoma, malignant melanoma, squamous cell carcinoma, or precursors of such lesions.

[0014] Patent Document 2 discloses a biological monitoring device. It describes the use of microneedles and a flexible interface, and discloses techniques related to electrocardiograms, sleep evaluation, bruxism evaluation, sleep apnea, and traumatic brain injury.

[0015] In Patent Document 3, a biosignal processing circuit board is fixed to a mounting holder in a housing that contains the board, and connection pins extending from the biosignal processing circuit board are inserted into through holes opened in multiple locations in the housing that contains the biosignal processing circuit board, and contact with the connection portion of the electrode connection wiring of the bioelectrode pad, thereby achieving an electrical connection to the electrode connection wiring (paragraph 20). However, simply having the tips of the connection pins extending from the biosignal processing circuit board contact the connection portion of the electrode connection wiring is not sufficient to guarantee a robust connection, as factors such as the surface precision of the connection pin tips, distortion of the housing, and oxide film on the electrical connection wiring can lead to unstable biosignal acquisition. Furthermore, although it is stated that the biosignal processing circuit board can be reused by inserting and removing the connection pins from the mounting holder, it is clear that this structure is costly in terms of parts due to the many components, such as the mounting holder, required for connection to the disposable bioelectrode pad.

[0016] Recent trends in biological monitoring present a challenge in electroencephalography (EEG) measurements: without pre-measurement treatment such as exfoliation of the subject's skin, it is impossible to reduce the contact impedance between the skin and electrodes, thus hindering the acquisition of accurate bioelectrical signals. This causes psychological and physical stress for subjects seeking early detection of early signs of diseases such as dementia and epilepsy, and no effective countermeasures have been found to date. Minimizing this psychological and physical stress would lead to the advantage of simple, accurate, and stress-free EEG monitoring. Furthermore, if electrodes can be attached directly and more easily to the stratum corneum and subcutaneous muscle layer, it would be possible to perform electrotherapy, such as applying current from the electrodes, and confirm its effects in real time while conducting biological monitoring such as EEG.

[0017] Patent Document 4 proposes a bioelectrode device comprising an electrode sheet having at least one pair of electrodes for receiving bioelectrical signals, a wiring member for transmitting the received bioelectrical signals, a sensor module for outputting signals related to the bioelectrical signals to the outside, a connecting member for connecting the transmitted bioelectrical signals to the sensor module, and an adhesive sheet that can be attached to a living body in a manner that covers the electrode sheet.

[0018] Patent No. 5001950, Patent No. 6606067, International Publication No. 2019 / 188311, International Publication No. 2023 / 218891

[0019] When measuring bioelectrical signals in the skin, noise may occur in the measured waveform. This can make it difficult to see the desired waveform, potentially negatively impacting the measurement. The noise is thought to be caused by the resistance of the stratum corneum of the skin, so it is necessary to reduce the electrical resistance caused by the stratum corneum. In addition, noise can also be generated by force moments caused by human movement or malfunctions or poor contact between the sensor module and electrodes when transmitting bioelectrical signals obtained from the skin from the electrodes to the sensor module. Therefore, ensuring good contact between the skin, electrodes, and sensor module is a key challenge.

[0020] According to generally considered embodiments, such as those described in Patent Document 2, a rivet-type stud configuration (button-top, snap interconnection) is employed. In the rivet-type stud configuration, electrodes that come into contact with the skin are attached to a substrate with an adhesive layer or adhesive, conductive gel, etc. that adheres to the skin. A rivet-type stud is provided, penetrating the thickness of the substrate, to provide electrical conductivity to a sensor module placed on the other substrate surface that is not on the skin side, i.e., the substrate surface without the adhesive layer or adhesive, conductive gel, etc. This makes it easy to replace disposable adhesive electrode patches and sensor modules.

[0021] However, the ease with which the electrode patch and sensor module can be attached and detached means that the fixation between the electrode patch and the sensor module is unstable. In other words, any wobbling of the sensor module increases the risk of noise generation. Furthermore, even if it is not a rivet-type stud type, if the position of the electrode that contacts the skin on the sensor module is separated from the skin surface by the thickness of the substrate, the sensor module is more prone to vibration in terms of force moment, increasing the risk of noise generation.

[0022] Furthermore, if sensor modules, electrodes, and wiring are mixed on both sides of the substrate due to the adoption of a rivet-type stud system, the costs of the rivet-type studs, laminated materials, and manufacturing processes will increase. This, along with the points raised in Patent Document 3, clearly represents a significant disadvantage when aiming for a disposable adhesive type.

[0023] Furthermore, from the perspective of wearability, while it is essential to attach electrodes and modules to human skin, attaching them more firmly leads to a greater feeling of discomfort for the user. Therefore, reducing this discomfort is also a challenge.

[0024] Even if electrical resistance caused by the stratum corneum can be reduced by arranging the aforementioned needle-shaped electrodes or conductive probes with multiple electrodes, this alone is insufficient. In other words, to solve these problems, there is a need for an electrode sheet that can transmit bioelectrical signals extracted from needle-shaped electrodes or conductive probes with multiple electrodes to the sensor module while maintaining low resistance, easily perform multi-point measurements necessary for electroencephalogram measurement, and simultaneously address issues such as stuffiness at the interface between the skin and the attached electrodes after the electrodes are attached to the subject, flexibility in following the stretch of the skin, and a sense of unity with the sensor module.

[0025] In particular, when it comes to inexpensive electrode sheets, mass production must be considered, and the wiring from conductive probes with needle-shaped electrodes or multiple electrodes to the sensor module has to rely on printing technology using conductive pastes such as silver, carbon, and PEDOT.

[0026] However, in the case of low-resistance, stretchable printed wiring, there is a limit to the printing height at which a single wire can be printed, and the printing line width must be increased in order to maintain low resistance wiring. Therefore, there is no problem if only a few electrodes are used to detect bioelectrical signals and transmit them to a module, but when considering electrode sheets for multi-point measurements necessary for electroencephalography (EEG) and other applications, the large printing line width inevitably results in electrode sheets with a large surface area. For example, it may be impossible to attach an electrode sheet to a subject's forehead, or the large surface area may cause discomfort due to moisture buildup at the interface with the skin.

[0027] Furthermore, even with needle-shaped electrodes, the overall size of the needle-shaped electrode is several millimeters due to manufacturing constraints, which presents problems in terms of embedding it in an electrode sheet and maintaining conductivity on the electrode sheet.

[0028] The invention described in Patent Document 4 proposes providing an electrode sheet structure with low resistance, thereby strengthening the fixation of the skin, electrode, and sensor module, reducing noise caused by force moments, and reducing the discomfort felt by the subject when the sheet is applied. However, the formation of the wiring members of the electrode sheet in the embodiment is achieved by using a special printing method that allows for printing with a high aspect ratio (thick printing) and simultaneously performs filling into through holes and printing high aspect ratio wiring.

[0029] This invention was made to solve the above-mentioned problems and aims to provide an electrode sheet structure with low resistance.

[0030] To solve the above problems, one representative bioelectrode device of the present invention comprises an electrode sheet having at least one pair of electrodes that receive bioelectrical signals, a wiring member that transmits the received bioelectrical signals, a sensor module that outputs signals related to the bioelectrical signals to the outside, and a connecting member that connects the transmitted bioelectrical signals to the sensor module. The connecting member is inserted into a hole drilled in the wiring member with an interlocking fit tolerance of "interlocking fit" or "interference fit," and has a sliding portion that allows the wiring member to slide up as it is dragged along the side of the connecting member, so that the wiring member, the connecting member and the electrodes are in close contact and fixed. Furthermore, this interlocking fit tolerance of "interlocking fit" or "interference fit," and the sliding portion that allows the wiring member to slide up as it is dragged along the side of the connecting member and electrodes, ensures that the wiring member and the connecting member are in close contact and fixed, thus providing a stronger bond with the electrodes necessary for bioelectrical signal measurement and solving usability issues.

[0031] The present invention provides a low-resistance electrode sheet structure. Other problems, configurations, and effects will be clarified by the following description of embodiments for carrying out the invention.

[0032] Figure 1 shows an electrode sheet according to the first embodiment. Figure 2 shows an electrode sheet according to the second embodiment. Figure 3 shows the attachment of the electrode sheet to the forehead of a subject. Figure 4 shows an interference fit. Figure 5 shows an interference fit. Figure 6 shows a method of mounting the electrode sheet to a subject according to the first embodiment. Figure 7 shows a method of mounting the electrode sheet to a subject according to the third embodiment. Figure 8 shows a conventional mounting method. Figure 9 shows a conventional mounting method. Figure 10 shows an electrode sheet according to the fourth embodiment. Figure 11 shows an electrode sheet according to the fifth embodiment. Figure 12 shows an electrode sheet according to the sixth embodiment. Figure 13 shows an electrode sheet according to the seventh embodiment. Figure 14 shows an electrode sheet according to the eighth embodiment. Figure 15 shows the manufacturing process of the electrode sheet according to the eighth embodiment. Figure 16 shows the manufacturing process of the electrode sheet according to the eighth embodiment. Figure 17 shows the manufacturing process of the electrode sheet according to the eighth embodiment. Figure 18 shows an electrode according to the eighth embodiment. Figure 19 is a diagram showing an electrode sheet according to the eighth embodiment. Figure 20 is a diagram showing an electrode according to the ninth embodiment. Figure 21 is a diagram showing an electrode sheet according to the tenth embodiment. Figure 22 is a diagram showing an electrode sheet according to the tenth embodiment. Figure 23 is a schematic diagram of an electrode sheet according to the eleventh embodiment. Figure 24 is a schematic diagram of electrode fixing for the electrode sheet according to the eleventh embodiment. Figure 25 is a schematic diagram of module or terminal fixing for the electrode sheet according to the eleventh embodiment. Figure 26 is a schematic diagram according to the thirteenth embodiment. Figure 27 is a schematic diagram of a cross-sectional structure according to the thirteenth embodiment. Figure 28 is a schematic diagram according to the fourteenth embodiment. Figure 29 is a schematic diagram of a cross-sectional structure according to the fourteenth embodiment. Figure 30 is a schematic diagram according to the fifteenth embodiment. Figure 31 is a schematic diagram of a cross-sectional structure according to the fifteenth embodiment. Figure 32 is a schematic diagram according to the sixteenth embodiment. Figure 33 is a schematic diagram according to the seventeenth embodiment.

[0033] Embodiments of the present invention will be described below with reference to the drawings. However, the present invention is not limited to these embodiments. Furthermore, in the drawings, identical parts are denoted by the same reference numerals.

[0034] This embodiment features a structure in which conductive electrodes and a sensor module, which directly or indirectly extract electrical signals generated from a living organism, are brought into close contact with human skin.

[0035] In this embodiment, the electrode and sensor module are mounted on the same surface of the electrode sheet or on one side of the electrode sheet, and can be fixed with an adhesive sheet while in contact with the skin surface. Furthermore, mounting on one side reduces the amount of material used and simplifies the manufacturing process, thus reducing costs.

[0036] As shown in Figure 1, the device has a needle-shaped member 101 consisting of at least one pair of electrodes that come into contact with the body to receive bioelectrical signals, a wiring member 102 that transmits the received bioelectrical signal voltage, and a connecting member 103 connected to a sensor module 105 that outputs the bioelectrical signal voltage to the outside. The electrode sheet 106, which integrates the needle-shaped member 101, wiring member 102, wiring reinforcement material 108, connecting member 103, sheet member 104, and sensor module 105, is then covered with an uppermost adhesive sheet 107 to provide adhesion and support to the skin. As a result, the needle-shaped member 101 and sensor module 105 are in contact with the body, and at least the wiring member 102, sheet member 104, and uppermost adhesive sheet 107 are characterized by their elasticity and flexibility.

[0037] Specifically, in the electrode sheet 106 shown in Figure 1, two connecting members 103 protrude symmetrically from the sensor module. The voltage of the bioelectrical signal received from the needle-shaped member 101 is connected to each of these two connecting members 103 via the wiring member 102, and the sensor module 105 receives the obtained voltage. The more seamlessly the path from the needle-shaped member 101 to the sensor module 105 in this reception process integrates with the skin of the body, the more effectively noise generation due to shaking and wobbling of the sensor module 105 caused by movements of the body can be suppressed.

[0038] Therefore, to ensure that the sensor module 105 and the needle-shaped member 101 are in close contact with the skin, an electrode sheet 106 is formed so that the tip of the needle-shaped member 101 and the sensor module 105 are close to the skin surface as shown in Figure 1. After attaching it to the living skin surface, an adhesive sheet is attached to the side opposite to the tip of the needle-shaped member 101 and the sensor module 105, covering the entire electrode sheet 106 and sensor module 105. At this time, the area ratio of the adhesive sheet to the electrode sheet 106 and sensor module 105 is preferably 5 to 6 or more, when the area occupied by the electrode sheet 106 and sensor module 105 is considered to be 1. This ensures stable fixation of the electrode sheet 106 and sensor module 105.

[0039] (Needle-shaped member) The needle-shaped member 101 is a type of electrode, and the needle-shaped member itself may already possess conductivity, or a conductive layer may be coated over the entire surface of the needle-shaped member.

[0040] The needle-shaped member 101 is positioned so that a needle-shaped projection (hereinafter simply referred to as "needle") can press into or puncture the patient's skin. Such pressing or puncture reduces the electrical resistance of the skin. The needle-shaped member 101 is positioned so that a needle with a cross-section on the order of tens of micrometers can puncture living tissue without causing significant trauma.

[0041] The needle-like member 101 preferably has a support 101a for arranging needles. Further, it is desirable that the needle-like member 101 has a plurality of needles protruding below the support 101a. The length of the needles is preferably in the range of 50 μm (hereinafter sometimes referred to as "micron") to 300 microns, and further, the outer periphery of the needles preferably has an outer diameter range of 10 microns to 250 microns. Regarding the length of the needles and the outer diameter range of the outer periphery of the needles, depending on the fixing method of the needle-like member 101, the length of the needles may be insufficient, and it may have a length of 300 microns or more, for example, 800 microns or more, and accordingly, the outer diameter range of the outer periphery of the needles may also have 250 microns or more. The upper side of the support 101a may be a flat surface, a two-stage concentric stepped shape, a two-stage concentric reverse taper shape, a rectangular parallelepiped or a reverse taper rectangular parallelepiped that is not a concentric circle, or a quadrangular prism.

[0042] The needles of the needle-like member 101 can take various shapes and forms. For example, the distal end may be pointed or not pointed, and may also take a beveled form, a parabolic form, a form with a flat tip, a form with a pointed tip, a form with a non-pointed tip, a form with a rounded tip, a tapered form and / or a tapered conical form. The needle-like member may be provided as a multi-dimensional array in contrast to an instrument provided with a single needle or a row of needles.

[0043] The needle-like member 101 can include a form combining the area, orientation, height or other parameters of the needles. For example, the larger the surface area of the conductive layer, the larger the effective surface area as an electrode, and thereby, the electrical resistance of the skin can be reduced. Also, if the needle-like member 101 is easily pierced into the skin and easily reduces the electrical resistance, it is also possible to devise a smaller area of the conductive layer. The thickness of the conductive layer is preferably about 0.01 μm to 5 μm. If it is thinner than this, conductivity cannot be maintained, and if it is thicker than this, there is a concern that the adhesion to the substrate will be impaired.

[0044] The needle-shaped member 101 is made by known microfabrication processes by making small mechanical structures from metals, polymers, and other materials. These microfabrication processes can be supplemented with other known methods used in the microfabrication field that are established methods used to fabricate integrated circuits, electronic packages, and other microelectronic devices.

[0045] Microfabrication processes available for use in fabricating the needle-shaped member 101 disclosed herein include lithography, etching techniques such as wet etching, dry etching, and photoresist removal, electroplating and electroless plating, diffusion processes such as boron diffusion, phosphorus diffusion, arsenic diffusion, and antimony diffusion, ion implantation, film deposition such as vapor deposition (filament, electron beam, flash, and shadowing step coverage), sputtering, chemical vapor deposition (CVD), epitaxy (vapor phase, liquid phase, and molecular beam), electroplating, screen printing, bonding, stereolithography, laser processing, and laser ablation (including projection ablation), metal punching, and metal pressing processes.

[0046] The needle-shaped member 101 is made from a conductive material belonging to the following ranges, and such conductive materials include, but are not limited to, metals, ceramics, semiconductors, organics, carbon, graphene, polymers, and composites. Preferred materials include nickel-titanium alloys, medical stainless steels, gold, titanium, nickel, iron, gold, platinum, tin, chromium, copper, alloys of these materials or other materials, silicon, silicon dioxide, capacitive carbon, graphene, graphite, and polymers. For polymers, specifically, highly conductive PEDOT:PSS (a composite composed of poly(3,4-ethylenedioxythiophene) (PEDOT) and polystyrene sulfonic acid (PSS)), a composite of graphene and a thermoplastic resin, etc. can be mentioned. As an ideal embodiment, a material that is both a conductive material and a biocompatible material, such as a nickel-titanium alloy, titanium, or medical stainless steel, silver / silver chloride, silver chloride, is used.

[0047] Furthermore, using the needle-shaped member 101 as a master plate, molded versions of the needle-shaped member 101 can be produced by transfer molding technology via a duplicate plate. Examples of molding methods include thermal transfer molding, soft lithography molding, and injection molding. By coating the above-mentioned conductive material, it is also possible to obtain a needle-shaped member with a transfer-molded base and a conductive surface. For molded versions of the needle-shaped member obtained by transfer molding, it is desirable to select from polymers that ensure biocompatibility when puncturing the skin. For example, polycarbonate, polystyrene, epoxy resin, polyethylene, polymethyl methacrylate, and polyglycolic acid can be used.

[0048] In addition to the needle-shaped member 101 as illustrated above, the needle-shaped member 101 may include a shaft having a circular cross-section when viewed vertically. Alternatively, the cross-section of the needle-shaped member 101 may be non-circular. For example, the cross-section of the needle-shaped member may be polygonal (e.g., star-shaped, square, triangular, circular), oval, or another symmetrical or asymmetrical shape, or the needle-shaped member may even include a pseudo-pyramid (a shape similar to a pyramid, with a more pointed or partially concave tip), a cone, a polyhedron, a pyramid, or a prism.

[0049] In most embodiments, the needles are preferably directed perpendicular to the support 101a or at other angles. Preferably, the needles are directed perpendicular to the support 101a so that the density of needles per unit area of ​​the support 101a is high. However, the needles may consist of various orientations, various heights, or combinations of other parameters. Furthermore, the lengths of the needles may or may not be the same between them.

[0050] The needles may have a specific needle density (number of needles in a particular area). For example, a useful range for the spacing between needles is 100 to 10,000 microns, more preferably 100 to 3,000 microns. The outer diameter and needle length mentioned above are also important, and in combination with the spacing, it is crucial whether the needles actually penetrate the stratum corneum of the skin. In one embodiment, the needles may be at least about 10 needles / cm２ More preferably, at least about 10 to 1000 strands / cm ２ It has a needle density. Furthermore, this needle density contributes to ensuring uniformity in the depth to which the needle penetrates the skin.

[0051] In this embodiment, the needle-shaped member may be flexible to conform to the contour shape of the biological barrier to which it is applied, such as the skin. Skin puncture may be limited by variations in the mounting surface of the biomedical electrode. For example, the unevenness of the human skin surface due to wrinkles and body hair can be a limiting factor in skin puncture. Flexibility may mean that when a load of 4 kgf is applied to both ends of a 1 cm area, it deforms by 0.1 mm to 5 mm.

[0052] (Conductive Member) The conductive member used in this embodiment is less expensive than the needle-shaped member. The needle-shaped member is directly inserted into the skin to acquire bioelectrical signals, but the conductive member is loaded into the electrode sheet 106 in place of the needle-shaped member, and a conductive gel containing an electrolyte is interposed between the skin and the conductive member to acquire bioelectrical signals.

[0053] The conductive member is made from a conductive material belonging to the following range, and such conductive materials include, but are not limited to, metals, ceramics, semiconductors, organic materials, polymers, and composites. Preferred materials include nickel-titanium alloys, medical-grade stainless steel, gold, titanium, nickel, iron, gold, platinum, tin, chromium, copper, alloys of these materials or other materials, silicon, silicon dioxide, capacitive carbon, graphite, and polymers. Specific examples of polymers include highly conductive PEDOT:PSS (a composite of poly(3,4-ethylenedioxythiophene) (PEDOT) and polystyrene sulfonic acid (PSS)). An ideal embodiment uses a material that is both conductive and biocompatible, such as nickel-titanium alloy, titanium, or medical-grade stainless steel, silver / silver chloride, or silver chloride.

[0054] However, the conductive component is not an essential part of the configuration, and the wiring component 102 may serve as a substitute for the conductive component.

[0055] (Wiring members, wiring reinforcement materials) The structure of the wiring members and wiring reinforcement materials related to the biomedical electrodes of this embodiment will be described in detail. The wiring members and wiring reinforcement materials in this embodiment are formed using a screen printing method. However, this embodiment may also be realized using printing methods other than screen printing, such as rotary screen printing, inkjet printing, gravure printing, offset printing, flexographic printing, dispensing printing, etc.

[0056] The wiring members and wiring reinforcement materials that can be used in this embodiment are wiring members and wiring reinforcement materials that are printed as printing ink using a coating agent containing a mixture of filler and binder (main component) and a main solvent which is the solvent for the binder, with additives that are compatible with the coating agent.

[0057] In this embodiment, inorganic and organic fillers can be used as fillers for wiring components and wiring reinforcements. Inorganic fillers are classified into metals and nonmetals. Organic fillers mainly consist of polymer compositions.

[0058] Metals are classified into noble metals and base metals. For example, noble metals include gold, silver, platinum, and palladium, while base metals include iron, copper, nickel, aluminum, lead, zinc, tin, tungsten, molybdenum, tantalum, magnesium, cobalt, bismuth, cadmium, titanium, zirconium, antimony, manganese, beryllium, chromium, germanium, vanadium, gallium, hafnium, indium, niobium, rhenium, and thallium. Gold, silver, and copper are particularly useful in this embodiment. Nonmetals are elements other than the aforementioned metals. For example, in terms of reactivity, reactive nonmetals include hydrogen, carbon, nitrogen, oxygen, fluorine, phosphorus, sulfur, chlorine, bromine, selenium, iodine, and astatine; noble gases include helium, neon, argon, krypton, xenon, and radon; and metalloids with nonmetallic chemical properties include boron, silicon, germanium, arsenic, antimony, and tellurium.

[0059] However, inorganic fillers also include substances in which multiple elements are chemically bonded, such as calcium carbonate, silica, carbon black, graphite, carbon nanotubes, alumina, aluminum nitride, boron nitride, beryllia, barium titanate, lead zirconate titanate, ferrite, CMC (carboxymethyl cellulose), titanium dioxide, glass beads, magnesium oxide, hydrotalcite, barium sulfate, titanium dioxide, zinc oxide, iron oxide, calcium oxide, magnesium oxide, zeolite, calcium oxide, and magnesium oxide.

[0060] Organic filler polymer compounds include linear polymer compounds formed in a filamentous or chain-like structure by chemically bonding the inorganic filler in a one-dimensional structure through chemical reactions such as addition polymerization, condensation polymerization, addition-condensation, and covalent bonding, as well as network polymer compounds having a three-dimensional structure linked by covalent bonds or the like.

[0061] Inorganic fillers used in wiring components and wiring reinforcements refer to inorganic compounds in which copper, silver, silicon, etc., are chemically bonded with oxygen, hydrogen, carbon, etc., and are based on metal atoms that have electrical and thermal conductivity.

[0062] Organic fillers used include polymers having urethane bonds, such as polyurethane, which are usually produced by polyaddition of compounds having isocyanate and hydroxyl groups, resulting in urethane resins with urethane (-NH・CO・O-) mediated bonds, or synthetic resins consisting of polymers of acrylic acid esters or methacrylic acid esters, such as urethane rubber acrylic resin, polymer compounds having amide bonds (the same bonds as proteins), and highly conductive polymer compounds such as PEDOT:PSS (a composite of poly(3,4-ethylenedioxythiophene) (PEDOT) and polystyrene sulfonic acid (PSS)).

[0063] The filler's shape can be spherical, flattened, needle-shaped, polygonal, etc., and its particle size is preferably between 0.1 μm and several tens of μm.

[0064] Binders that can be used for wiring components and wiring reinforcement materials include thermosetting resins, photocuring resins, and thermoplastic resins.

[0065] Thermosetting resins are the organic fillers in their pre-chemical reaction state, such as addition polymerization, condensation polymerization, addition condensation, or covalent bonding. They are relatively low-molecular-weight substances that, upon heating, form a three-dimensional crosslinked polymer structure (network structure). Examples include phenolic resins, amino resins, unsaturated polyester resins, epoxy resins, and silicone rubbers. Once cured, these resins do not soften again even when heated.

[0066] Thermosetting resins have a wide reaction temperature range, from room temperature to high temperatures, and react by addition polymerization, condensation polymerization, addition condensation, covalent bonding, etc. For example, elastomers such as silicone rubber are mainly made from polyorganosiloxanes (silicone polymers) whose polymer backbone (main chain) consists of siloxane bonds (Si-O-) in which silicon and oxygen atoms are arranged alternately. These can be divided into HTV (High Temperature Vulcanizing rubber), LTV (Low Temperature Vulcanizing rubber), and RTV (Room Temperature Vulcanizing rubber). The curing temperature for HTV is 140°C or higher, for LTV it is 40-140°C, and for RTV it is 0-40°C. However, due to diversification, the boundary between HTV and LTV has disappeared, and they are often simply divided into heat-curing and room-temperature curing types.

[0067] Furthermore, depending on the properties before curing, they can be divided into solid Mirable type (HCR; High Consistency Rubber) and liquid type. The liquid type includes LSR (Liquid Silicone Rubber) and RTV product groups. HCR uses linear gum with a degree of polymerization of about 5,000 to 10,000, while liquid silicone rubber (LSR, RTV) mainly consists of linear polymers with a degree of polymerization of about 100 to 2,000. In addition, they can be classified into peroxide curing, addition reaction curing, and condensation reaction curing depending on the crosslinking mechanism.

[0068] Photocurable resins are resins that polymerize and harden when exposed to light of a specific wavelength. In short, binders are thermosetting resins, photocurable resins, thermoplastic resins, etc., that undergo the aforementioned chemical reactions or are used for fixing or bonding.

[0069] As binders used in wiring components and wiring reinforcement materials, resins that are rubber-elastic and porous can be applied, such as polyurethane-based thermoplastic elastomers, thermoplastic polyurethanes, thermosetting urethane elastomers, polyester-based resins, acrylic rubber and polypropylene, acrylic elastomers mainly composed of polyester, and thermoplastic elastomers having block copolymers of methyl methacrylate and butyl acrylate.

[0070] For use as a solvent in printing inks, a composition containing the compound represented by the following structural formula (1) (excluding monohydroxystearic acid) can be used: R1-CH2-R2 (1) (wherein R1 represents a monohydroxyalkyl group, and R2 represents a carboxyl group (C(=O)OH) or an amide group (C(=O)NH2)).

[0071] Specifically, the solvents include n-heptane, 2-(2-ethoxyethoxy)ethyl acetate, ethylene glycol monoethyl ether acetate, n-propanol, 1,2,5,6-tetrahydrobenzyl alcohol, diethylene glycol ethyl ether, 3-methoxybutanol, triacetin, propylene glycol monomethyl ether, cyclopentanone, γ-butyrolactone, cyclohexanone, propylene glycol-n-propyl ether, propylene glycol-n-butyl ether, dipropylene glycol methyl ether, 1,4-butanediol diacetate, 3-methoxybutyl acetate, propylene glycol diacetate, ethyl lactate acetate, ε-caprolactone, 1,3-butylene glycol diacetate, dipropylene glycol-n-propyl ether, 1,6-hexanediol diacetate, dipropylene glycol-n-butyl ether, and tripropylene glycol methyl ether. Examples include tripropylene glycol-n-butyl ether, undecane, decane, dodecane, cyclohexanol acetate, diethylene glycol monoethyl ether acetate, ethylene glycol methyl ether acetate, diethylene glycol monobutyl ether acetate, ethylene glycol monobutyl ether acetate, methyl acetate, ethyl acetate, propylene glycol monomethyl ether acetate, n-propyl acetate, dipropylene glycol methyl ether acetate, 3-methoxybutanol acetate, butyl acetate, isopropyl acetate, tetrahydrofuran, dipropylene glycol methyl-n-butyl ether, dipropylene glycol methyl-n-propyl ether, dipropylene glycol dimethyl ether, propylene glycol methyl-n-butyl ether, propylene glycol methyl-n-propyl ether, dimethylsiloxane, and the like.

[0072] However, in order to achieve a strong electrical connection through interference fit via through-holes with the connecting member and needle-shaped member of this embodiment without damage, the wiring reinforcement material should be harder than the wiring member and preferably have a hardness of 2B or higher based on the pencil hardness test JIS K5600-5-4 scratch hardness (pencil method). This makes it possible to protect the printed film, for example, made of silver filler and polymer compound, printed on the underlying layer, creating resistance to slippage and distortion due to interference fit, and reducing the risk of electrical connection failure due to damage.

[0073] (Interference Fit) Here, with reference to Figure 4, the interference fit will be explained. Figure 4 schematically illustrates how, when the connecting member 103 of the sensor module 105 is inserted into the opening of the sheet member 104 from the wiring reinforcement material 108 side using an interference fit, the hole in the stacked sheet member 104 is dragged along the side of the connecting member and shifts upward. An interference fit, as shown in Figure 4(a), refers to a state in which the relationship between the hole diameter 401 of the through hole and the shaft diameter 402 of the support 101a of the needle-shaped member 101 is shaft diameter > hole diameter. Due to the elastic force of the elastic sheet member 104 and the conductive wiring member 102 and wiring reinforcement material 108 in this embodiment, the effect of firmly fixing the needle-shaped member 101 and the connecting member 103 by the interference fit can be obtained. This relationship is generally referred to as "interference" or "fit tolerance," but the difference between the diameters of the shaft and the hole, i.e., the fit tolerance, varies depending on the material of the sheet, etc., so it cannot be specified here. However, the hole diameter is set to be 0 or less than the diameter of the support 101a. (Interlock Fit) An interlock fit is a state in Figure 4(a) where the "fit tolerance" is smaller compared to an interference fit. In other words, the relationship between the hole diameter 401 of the through hole and the shaft diameter 402 of the support 101a of the needle-shaped member 101 is such that the shaft diameter and the hole diameter are approximately equal, the shaft diameter is slightly larger, or the hole diameter is slightly larger when inserted. Due to the elastic force of the elastic sheet member 104 and the conductive wiring member 102 and wiring reinforcement material 108 in this embodiment, the effect of appropriately fixing the needle-shaped member 101 and the connecting member 103 can be obtained by the interlock fit. In the case of a mid-fit, the fit tolerance also varies depending on the material of the sheet and the processing accuracy of the components, so it cannot be specified here, but the hole diameter is set to be equal to the diameter of the support 101a, or within the range of 0 to plus or minus (slightly larger or smaller).

[0074] Figure 4(b) shows that the support 101a of the needle-shaped member 101 is not a simple cylindrical shape, but rather has a stepped boss shape on the upper side of the support, allowing for a strong electrical connection and an enlarged electrode area through interference fit. Furthermore, by changing the concentric cylinder of the second step of the stepped boss shape to an inverse taper shape, a rectangular parallelepiped or an inverse taper rectangular parallelepiped instead of concentric circles, or the male side shape of a commercially available rivet-type stud (button top, snap interconnect), it is possible to enlarge the contact area of ​​the needle-shaped member 101 with the living body and incorporate a more versatile electrode. Figure 4(c) illustrates the case where interference fit is used to attach the sensor module 105. In the case of the sensor module 105, as with the needle-shaped member 101 described above, the connecting member 103 is attached to the sheet member 104 using the interference fit structure, thereby ensuring a strong electrical connection with the wiring member 102.

[0075] Figure 4(d) schematically shows the shape in which the connecting member 103 is firmly connected by interference fit due to the elastic force of the wiring reinforcement material 108. As indicated by the arrows in Figures 4(b) and (c), the interference fit causes the urethane sheet 104a, wiring member 102, and wiring reinforcement material 108 to experience stress in the direction of upward displacement at the parts that come into contact with the connecting member 103. As a result, the urethane sheet 104a, wiring member 102, and wiring reinforcement material 108 bend upward as schematically shown in Figure 4(d), and the strain force from this bent state firmly tightens the connecting member 103, achieving a strong connection.

[0076] (Sheet Member) The flexible sheet or stretchable sheet used for the sheet member on which the wiring pattern of the wiring member according to this embodiment is printed will be described below.

[0077] The flexible sheets or stretchable sheets that can be used in this embodiment are OPP (biaxially oriented polypropylene), CPP (unoriented polypropylene), HDPE (high-density polyethylene), MDPE (medium-density polyethylene), LDPE (low-density polyethylene), L-LDPE (linear low-density polyethylene), PET (polyethylene terephthalate), PEN (polyethylene naphthalate), O-NY (nylon), PA (polyamide), EVAC (EVA resin), PVC (polyvinyl chloride), SAN (AS resin), ABS (ABS resin), PMMA (methacrylic resin), PVAL (polyvinyl alcohol), PVDC (salt). (Polyvinylidene chloride resin), PC (polycarbonate), POM (acetal resin), PBT (polybutylene terephthalate), PTFE (fluororesin), PF (phenol resin), MF (melamine resin), UF (urea resin), PUR (polyurethane), TPU (thermoplastic polyurethane elastomer), water-based polyurethane, PUD (polyurethane dispersion), gas barrier polyurethane, EP (epoxy resin), UP (unsaturated polyester resin), PS (polystyrene), KOP (polyvinylidene chloride coated OPP), AL (aluminum foil), AOP (PVA coated OPP / Tocello), PT cellophane (plain) Transparent cellophane, MST cellophane (moisture-proof cellophane, PVC coated), K cellophane (PVDC coated), VM (aluminum vapor-deposited film, transparent vapor-deposited film), co-extruded film (co-extrusion film), nonwoven fabric, NR (natural rubber), IR (isoprene rubber), BR (butadiene rubber), SBR (styrene-butadiene rubber), IIR (butyl rubber), NBR (nitrile rubber), EPM (ethylene-propylene rubber), EP (epoxy resin), EPDM (ethylene-propylene rubber), CR (chloroprene rubber), ACM (Acrylic rubber, copolymer of ethyl acrylate and chloromethyl vinyl ether), ANM (Acrylic rubber, copolymer of n-butyl acrylate and acrylonitrile), CSM (chlorosulfonated polyethylene rubber), PUR (polyurethane)It is composed of resin, U (urethane rubber), Si (silicone resin), Q (silicone rubber), VMQ (silicone rubber with vinyl and methyl groups), SR (silicone rubber), FKM (fluororubber, vinylidene fluoride rubber), FPM (fluororubber), EVA (ethylene vinyl acetate rubber), CO (epichlorohydrin rubber, homopolymer of epichlorohydrin), ECO (epichlorohydrin rubber), T (multi-layer rubber), copper foil, etc., and can be used in the form of a single layer or a laminated film of two or more layers.

[0078] In the following disclosure, when a flexible sheet is mentioned, unless there are special circumstances, it is possible to replace the flexible sheet with a stretchable sheet. In this embodiment as well, the sheet member 104 can be in the form of a single layer or a laminated film of two or more layers.

[0079] For example, when a wiring component is pattern-printed with a urethane-based printing ink, a urethane-based film can be selected for the printed surface layer, and a PET film can be selected for the underlying layer to provide rigidity. A primer and adhesive layer may be sandwiched between the urethane-based film and the PET film to improve adhesion. Furthermore, other types of sheets, primers, and adhesive layers may be optionally laminated below the PET film. When a wiring component is pattern-printed with a silicone-based printing ink, a silicone-based film can be selected for the printed surface layer, and a PET film can be selected for the underlying layer to provide rigidity. A primer and adhesive layer may be sandwiched between the silicone-based film and the PET film to improve adhesion. Furthermore, other types of sheets, primers, and adhesive layers may be optionally laminated below the PET film. Alternatively, the sheet component 104 may be formed using only a urethane-based film without using a PET film.

[0080] Here, a base film necessary for the film formation of the above-mentioned sheet material, as well as a protective film that takes into account handling and stain resistance during printing, may be provided. The material of the base film may be PET film, polyethylene film, etc., and is not limited to these.

[0081] In accordance with the above procedure, through holes for inserting and fixing the needle-shaped members 101 and connecting members 103 are made in the single-layer or laminated sheet member at the required locations using a punch, punch, pinnacle die, or die. These holes are intentionally made smaller than the diameter of the needle-shaped members 101 and connecting members 103 in order to strengthen the electrical connection between the printed wiring pattern and the needle-shaped members 101 and connecting members 103, for example, by screen printing, and are the key feature of this embodiment, as they allow the needle-shaped members 101 and connecting members 103 to be inserted into them by interference fit.

[0082] In this embodiment, the opening diameter must have an interference tendency with respect to the diameters of the needle-shaped member 101 and the connecting member 103. In other words, by changing the fit tolerance from a zero tolerance (interference fit) to a negative tolerance (interference fit) with respect to the diameter of the fixing portion of the needle-shaped member 101 and the connecting member 103, it is possible to eliminate wobbling of the needle-shaped member 101 and the connecting member 103 and ensure strong conductivity. In addition to this, reliability can be further improved by applying a conductive adhesive.

[0083] The opening diameter may be the diameter obtained by subtracting a percentage from -0% to -99.9% of the diameter of the fixing portion of the needle-shaped member 101 and the connecting member 103, more preferably from -0% to -40%, and particularly preferably from -0% to -18%.

[0084] In particular, conventional electrical connections to sensor sheets using rivet-type studs (button-top, snap interconnects) or magnetic connections, which are used to connect sensor modules and electrodes, are convenient in terms of versatility, but they have been a factor in driving up the material costs of disposable electrode sheets. However, this embodiment has the advantage of allowing the sensor module's connecting member 103 to be directly inserted into the hole while ensuring conductivity, thus saving material and reducing the unit cost of disposable patches.

[0085] For example, as shown in Figure 5, electrocardiogram and electroencephalogram electrode snaps (combining a prong and a pin) can be used directly as the connecting member 103 for the sensor module. In this case, by using the snap on the sensor module side for permanent use rather than the disposable electrode sheet side, the disposable electrode sheet side only needs to have holes for interlocking connections, resulting in an inexpensive electrode sheet. In this case, the electrode sheet 106 of this embodiment can be used with only the snap incorporated.

[0086] Alternatively, electrocardiogram (ECG) and electroencephalogram (EEG) electrode snaps may be incorporated into the insulating sheet 407 as shown in Figure 5(c), and inserted into the sheet member 104 as a connecting member 103 using an interference fit from the adhesive layer 104c side of the sheet member. This allows for connection between the male end of the ECG and EEG electrode snaps of the connecting member 103 and a commercially available sensor module 405 incorporating the female end 406 of the ECG snap, or to an electrode cable incorporating the female end of the ECG snap. As a result, the interference fit configuration of this embodiment can be applied in various ways.

[0087] For these interference fit configurations, methods to make them more robust may be used, as shown in Figure 26 and later. The needle-shaped member 101 or the connecting member 103 is inserted into the sheet member 104 by interference fit. The sheet member has a negative tolerance, and the opening diameter is the same as or slightly smaller than the diameter of the needle-shaped member 101 or the connecting member 103. The sheet member is processed into a donut shape with an outer diameter larger than the opening diameter, and the sheet member is heat-laminated to the sheet member concentrically with the opening diameter to reinforce it.

[0088] As a result, in the process of inserting the needle-shaped member 101 into the sheet member 104 using an interference fit, the side surface of the needle-shaped member 101 is pulled up by a heat press machine with an opening larger than the diameter of the needle-shaped member 101, prying open the opening in the sheet member with a negative tolerance. Consequently, the wiring member 102 is firmly attached to and held in contact with the side surface of the needle-shaped member 101, ensuring stable conductivity. At this time, a carbon layer may be coated as a protective conductive film for the wiring member 102. The heat laminating sheet on the side surface of the needle-shaped member 101 may be made of PET, PEN, polyethylene, polypropylene, polyimide, urethane, etc., and a heat sealant, which is a thermoplastic resin, may be applied to one side thereof.

[0089] Furthermore, this strengthens the rigidity around the needle-shaped member 101 or the connecting member 103, allowing the electrical connection with the wiring member 102 and the sheet member 104 to be maintained stably even if some stretching or distortion occurs.

[0090] Furthermore, as shown in Figure 28, as a preliminary step to the above embodiment, the needle-shaped member 101 or the connecting member 103 may be inserted into the sheet member 104 by interference fit. In other words, the needle-shaped member 101 or the connecting member 103 may be inserted in such a way that it completely closes the opening diameter of the sheet member with a negative tolerance. Then, for example, a circular thermoplastic polyurethane elastomer sheet 403 larger than the opening may be heat-laminated concentrically with the opening of the sheet member 104, or an adhesive layer may be applied to the adhesive side of the thermoplastic polyurethane elastomer sheet 403 and attached to cover the opening.

[0091] Subsequently, in the process of inserting the needle-shaped member 101 in the above configuration into the sheet member 104 using an interference fit, a hot press machine with an opening larger than the diameter of the needle-shaped member 101 can be used to pry open the portion of the sheet member that has been opened to a negative tolerance on the side surface of the needle-shaped member 101 while pulling it up. As a result, the wiring member 102 is firmly attached to and held in contact with the side surface of the needle-shaped member 101, ensuring stable conductivity. Furthermore, the pulling up of the thermoplastic polyurethane elastomer sheet 403, which is an elastic material, generates a resistive force 262 against the needle side of the needle-shaped member 101. This provides an effect that can counteract the resistive force 262 generated between the skin and the needle tip when it is applied to human skin, and a greater effect of the needle tip penetrating the human skin is obtained. The external force 264 can be varied by changing the elasticity of this thermoplastic polyurethane elastomer sheet. The elastomer sheet used here may also be a silicone elastomer sheet or an acrylic elastomer sheet.

[0092] (Conductive gel containing electrolyte) The conductive gel containing electrolyte used in this embodiment is obtained by adding a polymer material that exhibits flexibility, plasticity, and adhesiveness to an electrolyte solution in which at least one of amino acids, organic salts, and inorganic salts is dissolved, and then solidifying it into a gel. The polymer material that exhibits flexibility, plasticity, and adhesiveness is one that has a glass transition point below living temperature and a melting point above living temperature, for example, acrylic or polyurethane materials can be used. In this embodiment, "living temperature" means a temperature in the range of 0 to 40 degrees Celsius.

[0093] (Insulating Film) The insulating film that can be used in this embodiment is preferably made of a material that does not undergo strength degradation, deformation, melting, alteration, etc., during the desired usage time. For example, a sheet made of polyester resin such as polyethylene terephthalate, polybutylene terephthalate, polyethylene naphthalate, ethylene-terephthalate-isophthalate copolymer, or polyarylate, or a polyurethane resin, preferably an unstretched sheet, can be used. Alternatively, a resin sheet made of fluororesin such as polyvinyl fluoride, polyvinylidene fluoride, polytetrafluoroethylene, or ethylene-tetrafluoroethylene copolymer, or a polyimide resin, or RTV silicone rubber, or UV-curable silicone rubber can also be used.

[0094] These insulating films can be bonded to a desired area by methods such as heat fusion, dry lamination, or spray coating. Alternatively, they can be coated to a desired area by printing methods such as screen printing, gravure printing, flexographic printing, offset printing, or roll transfer printing. As the resin binder for the ink used, for example, acrylic resin, polyester resin, polyimide resin, polyurethane resin, or silicone resin can be used. In some cases, inorganic fillers such as titanium dioxide may be included. The thickness of the insulating coating is usually preferably about 5 to 300 μm.

[0095] (Connecting Members) The connecting members that can be used in this embodiment are basically connected to the sensor module or incorporated into the sensor module itself.

[0096] The material is made from conductive materials belonging to the following range, and such conductive materials include, but are not limited to, metals, ceramics, semiconductors, organic materials, polymers, and composites. Preferred materials include nickel-titanium alloys, medical-grade stainless steel, gold, titanium, nickel, iron, gold, platinum, tin, chromium, copper, brass, alloys of these materials or other materials, silicon, silicon dioxide, capacitive carbon, graphite, and polymers. Specifically, a high-conductivity polymer is PEDOT:PSS (a composite of poly(3,4-ethylenedioxythiophene) (PEDOT) and polystyrene sulfonic acid (PSS)). An ideal embodiment uses a material that is both conductive and biocompatible, such as nickel-titanium alloy, titanium or medical-grade stainless steel, brass, silver / silver chloride, silver chloride, and a surface treatment such as copper-tin plating or nickel plating. Pre-made products such as electrocardiogram snaps (crimped with genko and hoso) can also be used.

[0097] (Sensor Module) The sensor module 105 used in this embodiment may have the connecting member loaded and fixed inside the sensor module 105, or it may be fixed to the electrode sheet 106 side and inserted and connected to the sensor module 105 side. The external shape, function, etc. of the sensor module 105 are not particularly limited.

[0098] For example, as shown in Figure 6, when the electrode sheet of this embodiment is attached to a person's forehead, the sensor module 105 may have the function of wirelessly transmitting and receiving signals between the sensor module and a mobile phone, PC, radio wave transmitting / receiving base station, etc. In this case, it may include a two-dimensional or three-dimensional antenna for transmitting and receiving radio waves. This antenna may be arranged along the wall of the module housing or embedded therein. The antenna may be located inside the module, or an antenna separately printed on the electrode sheet may be used, connected to the sensor module 105 via a connecting member if necessary.

[0099] The sensor module 105 may also be connected via a wire to a mobile phone, PC, measuring device, etc., as shown in Figure 7. In the case of a wired connection as shown in Figure 7, it is possible to reduce the functions of the sensor module 105, and functions such as the antenna and power supply can be supplied externally, so the total weight of the electrode sheet 106 is reduced, and discomfort to the subject is lessened.

[0100] This embodiment may also include connecting multiple electrodes through connecting members as shown in Figure 10 (connecting to two or more electrodes, for example, four electrodes, or connecting to an external antenna). The sensor module may include a signal generator and one or more bioamplifiers, the signal generator configured to provide a signal between two or more of the electrodes (for example, swept across various frequencies at multiple frequencies within frequency ranges such as generally between 1 Hz and 10 GHz, between 1 kHz and 10 MHz, or between 5 kHz and 1 MHz). The bioamplifier is configured to capture one or more signals from two or more of the electrodes. A processor, gate array, digital signal processor, or associated miniature circuit is configured to analyze the captured signals to determine the bioimpedance of nearby tissue.

[0101] The bioamplifier is configured to capture bioelectrical signals (e.g., EKG (ElektroKardioGram), HR (HeartRate), EMG (ElectroMyoGraphy), EOG (ElectroOculoGraphy), EEG (ElectroEncephaloGraphy), ERG (ElectroRetinoGraphy), etc.) from electrodes. The sensor module may also include a power supply (e.g., primary battery, secondary battery, energy harvesting system, etc.). It is especially preferable that the power supply be replaceable, such as a flexible, thin, flexible battery, for occasions such as electrode sheet replacement and sensor module reuse. Therefore, each module may be a self-powered device. The sensor module may include a processor and an internal power supply.

[0102] As shown in Figure 7, a wired connection is also possible, which reduces the functionality of the sensor module 105 and allows functions such as the antenna and power supply to be supplied externally, thus reducing the total weight of the electrode sheet 106 and alleviating discomfort for the subject.

[0103] (Uppermost adhesive sheet member) The most distinctive feature of this embodiment is the placement of an adhesive sheet as the uppermost layer.

[0104] Conventional electrode sheets for acquiring bioelectrical signals have employed a method in which the electrode sheet and sensor module are placed separately, with the sensor module connected on top of the electrode sheet.

[0105] However, as shown in the wireless specifications in Figure 8 and the wired specifications in Figure 9, for example, when transmitting bioelectrical signals obtained from the skin from the electrode to the sensor module, the force moment caused by human movement, malfunctions or poor contact between the sensor module and the electrode, or positional relationship can become large, making it prone to generating noise. Furthermore, in most cases, the electrode sheet and sensor module were mounted independently on top of each other, with lead wires extending from the electrode sheet, folded back, and connected to the sensor module.

[0106] Therefore, in order to solve these problems, this embodiment adopts a specification in which an adhesive sheet 107 is attached to the top layer so as to completely enclose the electrode and sensor module. In other words, conventionally, the electrode member and sensor module were mounted on both sides of the electrode sheet, with the electrode sheet in between. However, this embodiment is characterized in that the electrode member (needle-shaped member 101) and sensor module are arranged on one side of the electrode sheet. As a result, even if a wire is extended from the sensor module, noise can be reduced by fixing the wire with the adhesive sheet 107. Consequently, the needle-shaped member 101 and the sensor module 105 come into direct contact with the biological surface, minimizing the force moment generated by the positional relationship between the electrode and the sensor module 105. The basic size of the adhesive sheet member is approximately 150 mm in width and 50 mm in height, and its shape can be arbitrarily changed.

[0107] Furthermore, the adhesive sheet can be printed with conductive ink, allowing for electromagnetic shielding, decorative pattern printing, or even the lamination of metal foil.

[0108] Furthermore, the pressure exerted by the needle-shaped component on the skin is also increased.

[0109] This adhesive sheet 107 has a base material / adhesive configuration, with the adhesive applied to the electrode and module fixing side. The thickness of the base material / adhesive configuration is preferably 10 μm to 200 μm. The base material contains a urethane resin and may contain at least one selected from the group consisting of ether-based polyurethane resin, ester-based polyurethane resin, and carbonate-based polyurethane resin, and its thickness is preferably 5 μm to 30 μm.

[0110] The adhesive is made of synthetic resin, preferably a urethane-based adhesive. The thickness of the adhesive layer is preferably 5 μm or more and 25 μm or less.

[0111] The tensile elongation at break of the laminated adhesive sheet 107 is 130% or more, and the tensile stress at 100% elongation is preferably 10 to 100 MPa, more preferably 10 to 30 MPa, and even more preferably 10 MPa or less. Within this range, there is an effect of appropriately following the unevenness and expansion / contraction of the biological surface when it is applied to a living body. In addition, the moisture permeability is 2000 g / m². ２ - Preferably, the breathability is 2 days or more, and within this range, there is an effect of evaporation due to the skin respiration of the living body, water vapor, and sweating. The adhesive sheet 107 may be porous. Furthermore, cuts or holes may be made at arbitrary positions such as around the sensor module 105 or electrode sheet 106 in order to further improve breathability and to provide an air venting effect around the sensor module 105 or electrode sheet 106.

[0112] Furthermore, the adhesive sheet 107 may be made of a silicone-based material or an acrylic-based material, as long as the same effect can be obtained.

[0113] [Evaluation Method] [Tensile Elongation at Breaking] The tensile elongation at breaking was measured according to the methods specified in JIS K7127:1999 (ISO 527-3:1995) "Plastics - Test methods for tensile properties - Part 3: Test conditions for films and sheets" and JIS K7161-1:2014 (ISO 527-1:2012) "Plastics - Determination of tensile properties - Part 1: General rules". For the measurement of tensile elongation at breaking, the adhesive sheet was cut into a dumbbell shape (test piece type 5), and the tensile breaking strength was measured using a tensile testing machine (Shimadzu Corporation, AGS-X 5kN). The test speed was set to 300 mm / min, the gauge length L0 was set to 25 mm, and the initial grip distance L was set to 80 mm. If the test specimen did not have a yield point, the tensile fracture strain was calculated as the tensile elongation at fracture. On the other hand, if the test specimen had a yield point, the nominal tensile fracture strain was calculated as the tensile elongation at fracture. When measuring the tensile elongation at fracture, the measurement was performed on a laminate formed only from the base material and adhesive.

[0114] [Tensile stress at 100% elongation] Similar to measuring the elongation at tensile fracture, test specimens were prepared in accordance with JIS K7127:1999 (ISO 527-3:1995) "Plastics - Test methods for tensile properties - Part 3: Test methods for films and sheets". Then, the tensile stress at 100% elongation was calculated as the stress when the strain reached 100%, in accordance with JIS K7161-1:2014 (ISO 527-1:2012) "Plastics - Determination of tensile properties - Part 1: General rules".

[0115] (Sheet coated with photocurable resin) The most distinctive feature of this embodiment is the placement of an adhesive sheet 107 on the top layer. However, it has been found that using a sheet coated with photocurable resin instead of this top layer adhesive sheet, and fixing it dry by curing it with light irradiation while the skin, electrode, and sensor module are in close contact, is also an effective means of solving the problems of the present invention. The electrode sheet 106 is attached to the subject's skin in a manner that covers the entire sensor module, but instead of the adhesive sheet 107, a sheet coated with photocurable resin on a porous film or PET film is used.

[0116] The photocurable resin is a photopolymerizable resin and may be a composite material (composite resin) that mixes bisphenol A-glycidyl methacrylate adduct (Bis-GMA), triethylene glycol dimethacrylate (TEGDMA), urethane dimethacrylate (UDMA), other diacrylates, triacrylates, inorganic fillers such as quartz, silicon nitride, and glass, or organic composite fillers including organic materials. The light source for curing may be a halogen lamp, xenon lamp, UV lamp, visible light LED, or UV light LED. By applying a sheet coated with the photocurable resin to a porous film or PET film instead of the adhesive sheet 107 of this embodiment to the forehead, head, crown of the head, torso, hands, and feet, and irradiating it with a light source for several seconds to tens of seconds, the photocurable resin hardens, adheres, and holds the hair, exhibiting an anchoring effect and achieving dry application to the subject.

[0117] After signal measurement is complete, the thin, film-like photocurable resin can be crushed with your fingertips, allowing you to remove the electrode sheet with minimal pain during peeling.

[0118] <Electrode Sheet> The electrode sheet according to the present invention will be described below with reference to several embodiments. However, it goes without saying that the present invention is not limited by these embodiments. In addition, in the drawings, components that are the same as or equivalent to those described above will be denoted by the same reference numerals, and their descriptions will be simplified or omitted.

[0119] [First Embodiment] Figure 1 shows an electrode sheet according to the first embodiment. The contents of the first embodiment will be described below in order of manufacturing.

[0120] First, the base material used in the first embodiment is one in which a wiring member 102 is screen printed onto the surface of a urethane-based sheet 104a as shown in Figure 1, and the wiring member 102 is laminated between a urethane-based sheet 104a, a urethane-based sheet 104b, and an adhesive layer 104c. In this embodiment, the laminated urethane-based sheet 104a, urethane-based sheet 104b, and adhesive layer 104c are collectively referred to as the sheet member 104. In this embodiment, a urethane-based sheet is used, but other sheet members such as silicone-based, PET, or PE may also be used.

[0121] To obtain the cross-sectional structure shown in Figure 1, first, a sheet is manufactured by printing the wiring member 102 and the wiring reinforcement material 108 onto a urethane sheet 104a. Next, in a sheet made by laminating a separate urethane sheet 104b and an adhesive layer 104c, a hole larger than the diameter of the support 101a is opened with a pinnacle blade so that the needle-shaped member 101 can make electrical contact and connect to the wiring member 102, and a hole larger than the diameter of the connecting member 103 is further opened with a pinnacle blade. Next, a sheet made by laminating a separate urethane sheet 104b and an adhesive layer 104c onto the sheet with the wiring member 102 printed on the urethane sheet 104a. Next, in order to insert the connecting member 103 into the sheet member 104 by interference fit, a hole smaller than the diameter of the connecting member 103 is opened with a pinnacle blade in the portion of the sheet member 104 where the wiring reinforcement material 108 is printed.

[0122] In Figure 1, the distance between the centers of the holes opened in the urethane sheet 104b and adhesive layer 104c for inserting the two connecting members 103 of the needle-shaped member 101 and the sensor module 105 was set to 20 mm, 20 mm, and 20 mm in a straight line. The holes for inserting the connecting members 103 into the sheet member 104 by interference fit were also opened at the center of the printing position of the wiring reinforcement material 108, with a distance of 20 mm between the centers of the connecting members 103. In this embodiment, a urethane sheet is used, but in order to flexibly respond to the wiring formation environment, such as the heat shrinkage rate, the aforementioned materials such as polyethylene naphthalate, PET, and polyimide sheets can also be used. Note that 109 is the adhesive surface of the adhesive sheet.

[0123] Although a pinnacle blade was used to form the through hole, a punch or punch may also be used. Figure 4 schematically illustrates how the hole in the stacked sheet member 104 is dragged upward by the side of the connecting member 403 when the connecting member 103 of the sensor module 105 is inserted into the opening of the sheet member 104 from the wiring reinforcement material 108 side using an interference fit.

[0124] For example, Figure 5(a) is a photograph of a commercially available electrocardiogram snap (a crimping device with a prong and pin) inserted into the sheet member 104 as a connecting member 103. This results in an interference fit for the connecting member 103, making electrical connection easier. The electrical connection between the connecting member 103 and the wiring member 102 may also be made by interference fitting with a conductive material other than the electrocardiogram snap. The white circular area shown in Figure 5(a) is the donut-shaped heat-laminated sheet that is visible through the material, as will be explained in Figure 27 later.

[0125] Next, the loading of the needle-shaped member 101 will be described. In Figure 1, the wiring member 102 is exposed through a hole opened in the urethane sheet 104b and the adhesive layer 104c. To electrically connect the needle-shaped member 101 to it, conductive adhesive is applied to the exposed surface of the wiring member 102 using a dispenser, and then the side of the needle-shaped member 101 without a needle is bonded to it. By allowing a certain curing time, the electrical connection between the wiring member 102 and the needle-shaped member 101 can be established. Note that the needle-shaped member 101 in the first embodiment may be replaced with a conductive member without a needle or a conductive gel containing an electrolyte.

[0126] Through this series of steps, the electrode sheet 106 is completed, excluding the sensor module 105 and the connecting member 103.

[0127] The diameter of the sensor module's connecting member 103 is preferably 1 mm to 10 mm, and more preferably 1 mm to 5 mm. A feature of this embodiment is that the diameter of the hole made in the wiring member 102 printed on the sheet member 104 using a pinnacle blade, punch, or similar tool is made smaller than the diameter of the connecting member 103. This allows for interference fit to be used to connect the connecting member 103 and the wiring member 102. Figure 5(a) shows how the interference fit causes the wiring member 103 to be dragged along the side of the connecting member and slide upward, as shown by 403.

[0128] The shape of the connecting member 103 used here is, for example, as shown in Figure 5, a male type (a crimped part with a prong and a pin) for electrocardiogram electrodes, with a maximum diameter of 4 mm, a minimum diameter of 3.65 mm, a height of 2.9 mm, and an arc-shaped tip. However, each dimension and shape can be changed depending on the thickness, rigidity, etc., of the sheet member 104. The shape of the connecting member 103 may also be a cylinder, a reverse-tapered cylinder, a prism, a polygon, or a needle shape.

[0129] Furthermore, regarding the height of the connecting member 103, in this embodiment it is considerably higher than the thickness of the sheet member 104, but it may be lower than in this embodiment as long as it is a height at which interference fit connection with the sheet member is established.

[0130] In this embodiment, the two connecting members 103 are connected to the two through holes of the sheet member 104 without any interference fit.

[0131] Next, an adhesive sheet 107 was prepared, with an adhesive layer applied to the surface 109 that would be attached to the electrode sheet 106. The urethane sheet 104a was then placed on the adhesive sheet 107 so that it was aligned with the adhesive layer side of the adhesive sheet, and the electrode sheet 106 was positioned in the center of the adhesive sheet 107.

[0132] Next, with reference to Figure 3, the state in which the electrode sheet is attached to the subject will be described. As shown in Figure 3, the electrode sheet 106 is attached to the subject's forehead 301, and the protective film on the surface of the adhesive sheet 107 on the opposite side of the forehead is peeled off. As a result, the adhesive sheet 107 is placed as the uppermost layer in this embodiment, and the entire electrode sheet and sensor module can be wrapped and attached to the forehead. A gap 302 may be formed at the interface between the forehead 301, the sensor module 105, the electrode sheet 106, and the adhesive sheet 107, and the adhesive sheet 107 covers the entire electrode sheet 106 and sensor module 105, maintaining a sense of unity with the subject's forehead 301. This makes it possible to stably maintain the needle of the needle-shaped member 101 that has been punctured into the stratum corneum of the subject's forehead 301.

[0133] If the needle of the needle-shaped member 101 is stably inserted, the sensor module 105 can be positioned in the center of the adhesive sheet 107, and the electrode sheet 106 can take the shape of the wiring member 102 spreading out symmetrically with respect to the center of gravity (center) of the sensor module 105. As a result, the needle-shaped member 101 can be mounted at a distance of 1 cm or more, 2 cm or 3 cm from the connecting member 103 of the sensor module 105. This allows the needle-shaped member 101 to maintain a stable insertion state without being affected by the gaps 302 in the adhesive sheet that occur around the sensor module 105. Furthermore, the height from the adhesive surface of the sensor module 105 can be set to 3 mm or less, 2 mm or 1 mm, reducing the gaps 302 in the adhesive sheet and allowing the needle of the needle-shaped member 101 to maintain an even more stable insertion state.

[0134] For example, as shown in Figure 5(c), when using a commercially available electrocardiogram snap (a crimped part with a prong and pin) as the connecting member 103, an adhesive sheet may be placed on the top layer to completely enclose the electrode sheet 106 and the sensor module 105.

[0135] This method provides a strong physical and electrical connection between the skin, electrodes, and sensor module, reducing noise caused by force moments, while also reducing discomfort to the subject during application. Furthermore, it allows for the use of common printing methods for forming the wiring components of the electrode sheet, thereby reducing manufacturing costs. In addition, even when the wiring components are made of flexible and stretchable materials such as thermoplastic elastomer sheets, the electrical connections between the wiring components and connecting components, and between the wiring components and the electrodes, are maintained more firmly using "interlocking" or "interference fitting" techniques. This also prevents a decrease in electrical connection due to irregular stretching during application to the subject. Moreover, it enables the electrodes to contact the subject's skin surface with appropriate pressure.

[0136] [Second Embodiment] Next, a second embodiment will be described with reference to Figure 2. Figure 2 is a diagram showing an electrode sheet according to the second embodiment. The second embodiment differs from the first embodiment in that the support for the needle-shaped member 101 also penetrates the sheet member 104. Figure 3 is a schematic cross-sectional view of a shoji screen according to the second embodiment in which an air passage is provided. In the following description, the same or equivalent components as those in the first embodiment described above will be denoted by the same reference numerals, and their descriptions will be simplified or omitted. The contents of the second embodiment will be described below in order of manufacture.

[0137] First, the base material used in the second embodiment is one in which a wiring member 102 is screen printed onto the surface of a urethane sheet 104a as shown in Figure 2, and the wiring member 102 is laminated between urethane sheets 104a, urethane sheet 104b, and an adhesive layer 104c. In this embodiment, the laminated urethane sheets 104a, urethane sheet 104b, and adhesive layer 104c are collectively referred to as the sheet member 104. In this embodiment, a urethane sheet is used, but other sheet members such as silicone, PET, or PE may also be used.

[0138] To obtain the cross-sectional structure shown in Figure 2, first, a sheet is manufactured by printing the wiring member 102 and the wiring reinforcement material 108 onto a urethane sheet 104a. Next, a sheet is prepared by laminating a separate urethane sheet 104b and an adhesive layer 104c. On this sheet, a hole larger than the diameter of the support 101a is opened with a pinnacle blade so that the needle-shaped member 101 can make electrical contact and connect to the wiring member 102, and a hole larger than the diameter of the connecting member is also opened with a pinnacle blade to insert the connecting member 103. Next, the sheet with the wiring member 102 printed on the urethane sheet 104a is laminated with the sheet with the separately laminated urethane sheet 104b and adhesive layer 104c. Next, in order to insert the needle-shaped member 101 and the connecting member 103 into the sheet member 104 by interference fit, holes smaller than the diameter of the needle-shaped member 101 and holes smaller than the diameter of the connecting member 103 were opened with a pinnacle blade in the printed portion of the sheet member 104 with the wiring reinforcement material 108.

[0139] In order to insert the needle-shaped member 101 and the two connecting members 103 of the sensor module 105 in Figure 2, the distance between the centers of the openings in the urethane sheet 104b and the adhesive layer 104c was set to 20 mm, 20 mm, and 20 mm in a straight line. Then, four holes were opened in the center of the printing position of the wiring reinforcement material 108, with a distance of 20 mm between the centers of each hole, for inserting the needle-shaped member 101 and the connecting members 103 into the sheet member 104 using interference fit. In this embodiment, a urethane sheet is used, but in order to flexibly respond to the wiring formation environment, such as the heat shrinkage rate, the aforementioned materials such as polyethylene naphthalate, PET, and polyimide sheets can also be used.

[0140] While a pinnacle blade was used to form the through-hole, a punch or punch tool could also be used.

[0141] Furthermore, the support 101a may not be a simple cylindrical shape, but rather have a stepped boss shape on its upper side. By making the boss shape a two-stage concentric stepped shape 101d (urethane sheet 104a and wiring member 102) that fastens together as shown in Figure 4(b), an effective and strong electrical connection can be ensured. The second concentric cylinder may be an inverted tapered shape, or a rectangular parallelepiped or an inverted tapered rectangular parallelepiped instead of concentric circles. By making the shape of the electrical connection part between the needle-shaped member 101 and the wiring member 102 a stepped boss shape, it is also possible to increase the connection area between the sheet member 104 and the support 101a. In addition, a good electrical connection can be achieved solely by the effect of interference fit without using the expensive conductive adhesive used in the electrical connection between the needle-shaped member 101 and the wiring member 102 in the first embodiment. Furthermore, the needle-shaped member 101 in this second embodiment may be replaced with a conductive member without needles or a conductive gel containing an electrolyte.

[0142] Unlike the first embodiment, this embodiment is an electrode sheet 206 in which two connecting members 103 and two needle-shaped members 101 are all connected to four through holes by interference fit.

[0143] [Third Embodiment] Next, a third embodiment will be described with reference to Figure 3. The third embodiment differs from the first and second embodiments in that the electrode sheet and the entire sensor module of the first and second embodiments are covered with an adhesive sheet and attached to the subject. In the following description, the same or equivalent components as those in the first embodiment described above will be denoted by the same reference numerals, and their descriptions will be simplified or omitted.

[0144] In the first embodiment, an impedance measuring device is connected to the electrode sheet and sensor module using a wired connection to the sensor module. The entire electrode sheet and sensor module, including this wire, is covered with an adhesive sheet. Even when the wire is shaken while the device is attached to the subject, the bioelectrode device of this embodiment exhibits an effect of virtually no noise interference.

[0145] In other words, by covering the electrode sheet and the entire sensor module with an adhesive sheet at the end, and also fixing some of the wires in place, the presence or absence of noise is directly related, and the effectiveness of this embodiment is achieved.

[0146] This is also true when using the electrode sheet and sensor module of the second embodiment.

[0147] Figure 6 shows the electrode sheet and sensor module of the first embodiment, which are wirelessly connected to an external device, attached to the subject with an adhesive sheet. Figure 7 shows the electrode sheet and sensor module of the first embodiment in a wired configuration, with an impedance measuring device connected by a wire, attached to the subject with an adhesive sheet. Furthermore, Figures 8 and 9 show, for comparison, the mounting state when the entire configuration shown in Figures 6 and 7 is not attached with an adhesive sheet.

[0148] [Fourth Embodiment] Next, a fourth embodiment will be described with reference to Figure 10. The fourth embodiment differs from the first embodiment in that it acquires two or more bioelectric signals from the electrode sheet. In the following description, components that are the same or equivalent as those in the first embodiment described above will be denoted by the same reference numerals, and their descriptions will be simplified or omitted.

[0149] Figure 10 shows an embodiment of the electrode sheet according to the first embodiment in which bioelectrical signals are acquired from two or more locations simultaneously. Alternatively, it shows an embodiment in which the electrode also serves as an electrode for electrotherapy, simultaneously applying current while acquiring bioelectrical signals. The basic manufacturing method is the same as the first embodiment, but while the first embodiment had two pairs of needle-shaped members 101 and connecting members 103 formed by drilling four through holes, this embodiment has eight through holes in which four pairs of needle-shaped members 101 and connecting members 103 are formed. Naturally, it is possible to drill even more through holes, which allows for multiple electroencephalogram measurement points, for example. However, the more points there are, the larger the wiring area on the electrode sheet becomes, so through holes 901 that are not used for measurement may be drilled in some places between the wiring of the electrode sheet. This reduces discomfort caused by dampness at the interface between the subject's skin and the electrode sheet.

[0150] This embodiment can also be applied to the second and third embodiments. For example, it is possible to conduct an electric current through a needle-shaped member based on bioelectrical signals obtained from a conductive gel and a conductive member. In other words, the bioelectric signals obtained from the conductive gel and conductive member can detect and analyze the brain waves, electromyography and electrocardiogram of other physical locations, and blood flow status of the target organism, while simultaneously sending weak electrical stimulation to the organism from the needle member, enabling continuous electrical treatment. In that case, the wired method according to the third embodiment can be made even more effective.

[0151] [Fifth Embodiment] Next, the fifth embodiment will be described with reference to Figure 11. The fifth embodiment differs from the electrode pads of the first to fourth embodiments in that the wiring member 102 has a meandering shape represented by 1001 and 1002, as shown in Figure 11. In the following description, the same or equivalent components as those of the first to fourth embodiments described above will be denoted by the same reference numerals, and their descriptions will be simplified or omitted.

[0152] In the fifth embodiment, as shown in Figure 11, the wiring member 102 has a meandering pattern. The meandering shape may be, for example, a regularly meandering horseshoe-shaped continuous wiring, or it may be an irregular pattern. The meandering shape should be such that the wiring member 102 can easily follow the expansion and contraction of the electrode pad, and the wiring member 102 should be composed of elements in at least two directions. When the wiring member 102 is formed on a flexible and stretchable substrate to form an electrode sheet, noise may be introduced due to the movement of the subject, the unevenness, expansion and contraction, and vibration of the application surface. In such cases, the meandering pattern 1001 shown in Figure 11 may be formed, or slits 1002 may be engraved in the electrode sheet at any location in the meandering pattern to allow for greater flexibility.

[0153] [Sixth Embodiment] Next, the sixth embodiment will be described with reference to Figure 12. The sixth embodiment differs from the first to fifth embodiments in that the wiring member 102 is provided with insulating layers 1101 and 1102 on its surface. In the following description, the same or equivalent components as those in the first to fifth embodiments described above are denoted by the same reference numerals, and their descriptions are simplified or omitted. In the first to fifth embodiments, the sheet member 104 can be composed of a single layer or two or more laminated sheets. In the first to fifth embodiments, a configuration using a urethane-based sheet with a three-layer structure was mainly shown.

[0154] However, even if, for example, three or more layers of urethane-based sheets are laminated or the thickness is increased, electrical insulation may be lost if the electrode sheets are attached and daily life continues for a long period of time, or if water erosion occurs due to sweat or showering.

[0155] Therefore, in the sixth embodiment, as shown in Figure 12, for example, insulating layers 1101 and 1102 are covered on the surface of the wiring member 102 by screen printing or lamination, thereby preventing short circuits caused by sweat from human skin and electrical short circuits caused by water from the outside. Note that the method for forming the insulating layers 1101 and 1102 is not limited to screen printing or lamination, and any appropriate film formation method can be used.

[0156] [Seventh Embodiment] Next, the seventh embodiment will be described with reference to Figure 13. The seventh embodiment differs from the first to sixth embodiments in that the adhesive sheet 107 is equipped with an electromagnetic shielding function. In the following description, the same or equivalent components as those in the first to sixth embodiments described above will be denoted by the same reference numerals, and their descriptions will be simplified or omitted. In the first to sixth embodiments, the adhesive sheet 107 is attached to the subject's skin in a manner that covers the entire electrode sheet and sensor module, as in the embodiments described above. All or some of the bioelectrical signal data obtained by the sensor module is transmitted to the outside by radio waves. In this case, electromagnetic waves emitted from the sensor module and electromagnetic waves entering from the outside may affect the electrode sheets 106 and 206.

[0157] Therefore, in the seventh embodiment, a solid or mesh pattern is printed on the adhesive sheet 107 using conductive ink by inkjet, in a manner that does not overlap with any part of the sensor module, and covering at least the sheet member 104. Here, "solid" is a printing term meaning a state where 100% of the surface is coated. A mesh pattern refers to a mesh-like pattern of an appropriate size that has an electromagnetic shielding (shielding of electromagnetic waves) effect. The solid or mesh pattern can be an appropriate pattern considering transparency, moisture permeability, and design. In the case of a solid, a design-oriented pattern such as a design, or a skin tone that appears to blend in with the skin, may be printed on the adhesive sheet 107 using conductive ink. These printing methods are not limited to inkjet, and offset printing, screen printing, gravure printing, flexographic printing, dispensers, and 3D printers may also be used. Alternatively, metal foil such as copper or aluminum that has a similar effect may be attached.

[0158] This prevents the induction of unintended currents within the sensor module and electrode sheet due to electromagnetic wave attacks on the sensor module and electrode sheet during transmission and reception between the sensor module and the outside, or on the electrode sheet. Figure 13 shows variations of the mesh pattern to be printed on the adhesive sheet. The mesh pattern 1202 may be printed on the entire surface 1210 of the adhesive sheet without printing it on a part 1201 of the sensor module, or it may be printed to cover only the electrode sheet portion 1211, or to cover only the wiring component portion 1212.

[0159] The mesh pattern is generally preferred to be as inconspicuous as possible. Fine wires with a line width of 30 μm or less, more preferably 15 to 20 μm or less, and a line thickness of 3 μm or less are arranged in a grid pattern with a pitch of 300 μm to 500 μm. The resulting surface resistivity is 40 Ω / □ or less, and more preferably 1.2 Ω / □ or less.

[0160] [Eighth Embodiment] Next, the eighth embodiment will be described with reference to Figures 14 to 18. The eighth embodiment differs from the first to seventh embodiments in that the needle-shaped member 101 is fixed to the electrode sheet (106, 206) by sandwiching the support 101a of the needle-shaped member 101 between the wiring member 102 and the adhesive sheet 107. In the following description, the same or equivalent components as those in the first to sixth embodiments described above will be denoted by the same reference numerals, and their descriptions will be simplified or omitted.

[0161] In the first to seventh embodiments, the electrode sheets (106, 206) ensured conductivity by completely integrating the electrode sheet 106 with the support 101a and connecting member 103 of the needle-shaped member 101 by loading the needle-shaped member 101 into a vertical through-hole using an interference fit. However, in the eighth embodiment, the base plane 101b and lower plane 101c of the support 101a of the needle-shaped member 101 shown in Figure 14 are sandwiched between layers of the wiring member 102 and the adhesive sheet 107, thereby ensuring integration with the electrode sheet 106 and conductivity. The wiring member here may be an ink containing silver, copper, or carbon filler, or a conductive polymer such as PEDOT / PSS.

[0162] Next, with reference to Figures 15 to 19, the manufacturing method of the electrode sheet according to the eighth embodiment will be described. First, in Figure 15, an insulating film 112a is printed on the release film 111, excluding the area 115 into which the connecting member 103 will be inserted in a later step. Then, the wiring member 102 is printed on top of that. Next, an insulating film 112b is printed, excluding the area 114 into which the needle-shaped member 101 will be inserted later. Drying and curing after printing in the above steps are performed as needed.

[0163] Next, as shown in Figure 16, holes 211 for inserting the needle-shaped member 101 and the connecting member 103 are punched through with a hole punch.

[0164] Next, as shown in Figure 17(a), the needle-shaped member 101 is inserted so that its support 101a contacts the wiring member 102 and the needle-shaped member 101 rests inside the hole 211. The needle-shaped member 101 can establish electrical conductivity with the wiring member 102 even by simply inserting it in this manner, but if necessary, a conductive adhesive may be applied to the contact area between the support 101a of the needle-shaped member 101 and the wiring member 102 and its surroundings.

[0165] Next, as shown in Figure 17(b), the adhesive sheet 107 is laminated to the entire surface, including the release film 111. The separator film 107a is laminated to this adhesive sheet 107.

[0166] Figure 18 is a cross-sectional view of the area near the needle-shaped member after the release film 111 has been peeled off the needle-shaped member 101, with the orientation inverted from the state shown in Figure 17(b). As shown in Figure 18, the needle-shaped member 101 is exposed through the hole 211, and the needle-shaped member 101 is firmly fixed to the electrode sheet 106. In the eighth embodiment, the needle-shaped member 101 is firmly sandwiched between the printed wiring member 102 and the adhesive sheet 107, and is integrally molded so that only the needle portion of the needle-shaped member 101 protrudes from the hole 211, thereby achieving complete electrical conductivity.

[0167] By following the steps shown in Figures 15 to 18, an electrode sheet 106 can be obtained in which the release film 111, insulating film 112a, wiring member 102, insulating film 112b, needle-shaped member 101, adhesive sheet 107, and separator film 107a are integrated. Furthermore, depending on the handling of the components and the packaging capacity, each sheet component may be divided and processed to an appropriate area and shape.

[0168] The adhesive sheet 107 and separator film 107a used here can also be those with multiple needle holes 515 pre-punched through a portion or the entire surface at arbitrary intervals, as shown in Figure 19.

[0169] When a subject inserts the connecting member 103 of the sensor module 105 into the hole 211 of the electrode sheet 106, the connecting member 103 may come into contact with the separator film 107a, making insertion difficult. In such cases, by providing a needle hole 515 in advance, the tip of the connecting member 103 can use the needle hole 515 of the separator film 107a as a starting point for insertion, allowing it to break a portion of the separator film 107a and make better contact with the hole 211. This makes the electrical conductivity from the connecting member 103 to the needle-shaped member 101 more reliable. An advantage of the needle hole 515 is that in the manufacturing process of the adhesive sheet 107, the needle hole 515 can be easily added by passing the adhesive sheet 107 and the separator film 107a through a device equipped with many sharp, needle-like embossed rolling rolls on a continuous line, such as a roll-to-roll system.

[0170] The size and number of these pinholes 515 can be changed arbitrarily, and circular or polygonal openings may be provided instead of pinholes.

[0171] [Ninth Embodiment] Next, the ninth embodiment will be described with reference to Figure 20. The ninth embodiment differs from the first to eighth embodiments in that it acquires biological signals using a conductive gel 208 containing an electrolyte instead of a needle-shaped member 101. In the following description, the same or equivalent components as those in the first to eighth embodiments described above will be denoted by the same reference numerals, and their descriptions will be simplified or omitted. Figure 20 is a cross-sectional view of an electrode pad that uses a conductive member 201 instead of the needle-shaped member 101 shown in Figure 18, as in the eighth embodiment, and enables the acquisition of biological signals via a conductive gel 208 containing an electrolyte instead of the needle-shaped member 101. In Figure 20, 201 indicates the conductive member and 208 indicates the conductive gel.

[0172] The manufacturing method of the electrode sheet according to the ninth embodiment will be described below, with reference to the drawings illustrating the manufacturing process of the eighth embodiment. In the ninth embodiment, as in the procedure shown in the eighth embodiment, first, an insulating film 112a is printed on the release film 111, excluding the area 115 into which the connecting member 103 will be inserted in a later step. Then, the wiring member 102 is printed on top of it. Next, the insulating film 112b is printed, excluding the area 114 into which the conductive member 201, which will replace the needle-shaped member 101, will be inserted later. Drying and curing after printing in the above steps are carried out as appropriate.

[0173] Next, as shown in Figure 16 of the eighth embodiment, a hole 211 is punched through the conductive member 201 and connecting member 103, which replace the needle-shaped member 101. Then, as shown in Figure 20, the conductive member 201 is inserted so that it contacts the wiring member 102 and a portion of the conductive member 201 rests inside the hole 211. The conductive member 201 can establish electrical conductivity with the wiring member 102 even by being inserted in this manner, but a conductive adhesive may be applied to the contact area and its surroundings if necessary.

[0174] The subsequent steps are the same as in the eighth embodiment, but in the ninth embodiment, an additional step is added in which the release film 111 is peeled off once before being attached to the subject, the conductive gel 208 containing the electrolyte is applied, and then the release film is reapplied.

[0175] [Tenth Embodiment] Next, the tenth embodiment will be described with reference to Figure 21. The tenth embodiment differs from the first to ninth embodiments in that a curable resin 222 is used instead of an adhesive sheet. In the following description, the same or equivalent components as those in the first to ninth embodiments described above are denoted by the same reference numerals, and their descriptions are simplified or omitted. In the first to ninth embodiments, the adhesive sheet 107 was attached to the subject's skin in a manner that covered the entire electrode sheet 106 and sensor module 105. In this respect, in the tenth embodiment, as shown in Figure 21, a sheet 221 is used in which a photocurable resin 222 is coated onto a porous film or PET film 223, instead of the adhesive sheet 107.

[0176] The photocurable resin 222 is mainly a photopolymerizable resin and may be a composite material (composite resin) mixed with bisphenol A-glycidyl methacrylate adduct (Bis-GMA), triethylene glycol dimethacrylate (TEGDMA), urethane dimethacrylate (UDMA), other diacrylates and triacrylates in their individual forms or mixtures, inorganic fillers such as quartz, silicon nitride, and glass, and organic composite fillers including organic materials. The light source for curing may be a halogen lamp, xenon lamp, UV lamp, visible light LED, or UV light LED.

[0177] As shown in Figure 22, sheets 221, which are made by coating a porous film or PET film 223 with photocurable resin 222, are attached to the forehead, head, crown of the head, torso, hands, and feet in place of the adhesive sheet 107 of this embodiment. By irradiating the photocurable resin 222 with light from a light source 231 for several seconds to tens of seconds, the photocurable resin hardens and adheres to the human body. Using photocurable resin 222 makes it possible to hold hair 232, exhibits an anchoring effect, and enables dry application. The light source 231 may be pressed against the sheet 221 for irradiation, which is preferable to make the film thickness of the photocurable resin 222 into a thin film. Basically, UV-A (wavelength 315 to 400 nm) is used as the light source 231. The required integrated light amount is 1 mJ / cm ２ From 4000 mJ / cm ２A range of 1 mJ / cm² is preferred. ２ From 2000 mJ / cm ２ A range of this magnitude is preferable, but ultimately, a moderate light intensity is selected that takes into account the impact on the human body.

[0178] After signal measurement is complete, the thin, film-like photocurable resin can be crushed with a fingertip, minimizing pain during removal and allowing for the removal of the electrode sheet.

[0179] The tenth embodiment can also be applied to the fixation of bioelectrode devices. It is particularly effective when needle-shaped members are used as electrodes.

[0180] [Eleventh Embodiment] Next, the eleventh embodiment will be described with reference to Figures 23 to 25. The eleventh embodiment differs from the first to tenth embodiments in that the electrode sheets (106, 206) are not integrated but are constructed in separate parts. In the following description, the same or equivalent components as those in the first to tenth embodiments described above will be denoted by the same reference numerals, and their descriptions will be simplified or omitted. In the first to tenth embodiments, the electrode sheet 106 and the sensor module 105 have an integrated shape. However, in the eleventh embodiment, by using the photocurable resin described in the tenth embodiment, the fixing 241 of the needle-shaped member and the fixing of the sensor module 105 or terminal 226 can be fixed separately, as shown in Figures 23 to 25. As the photocurable resin 222, a sheet 221 coated on a porous film or PET film 223 can be used and fixed in the same manner as in the tenth embodiment.

[0181] This makes it possible to connect a separate wire 243 to the area to be measured where hair is dense around the top of the head, in addition to the electrode sheet 106 or 206 attached to the forehead, and to fix a needle-shaped member to the tip, for example, in a satellite-like manner. It is also possible to separate the electrode sheet (106, 206) attached to the forehead and use only the part with the needle-shaped member fixed, for example, in a satellite-like manner, independently. This makes it possible to attach electrodes at 19 locations in accordance with the "10 / 20 method" recommended by the International Society of Electroencephalography. The 11th embodiment can be applied not only to the 10th embodiment but also to the fixing of bioelectrode devices. It is particularly effective when a needle-shaped member is used as an electrode.

[0182] [Twelfth Embodiment] The electrode sheet of the tenth or eleventh embodiment can be attached to the forehead, head, crown of the head, neck, torso, hands, feet, etc., and can also be used as an electrode sheet for electrotherapy.

[0183] [Third Embodiment] (Donut-shaped reinforcing member) Next, the thirteenth embodiment will be described with reference to Figure 26. The thirteenth embodiment is applicable to the first to twelfth embodiments and differs from the first to twelfth embodiments in that a reinforcing member made of a heat-laminated sheet processed into a donut shape concentric with the opening diameter of the wiring member 102 is placed above the urethane sheet 102a. In the following description, the same or equivalent components as those in the first to thirteenth embodiments described above will be denoted by the same reference numerals, and their descriptions will be simplified or omitted.

[0184] In Figures 26(a) to (c), the explanation uses the needle-shaped member 101 as an example, but the same applies to the case of the connecting member 103 instead of the needle-shaped member 101. In this disclosure, the needle-shaped member 101 and the connecting member 103 together may be referred to as the "through member". In the 13th embodiment, first, the diameter of the opening made in the wiring member 102 is made slightly smaller than the diameter of the needle-shaped member 101 or the connecting member 103. For example, if the diameter of the needle-shaped member 101 is 8 mm, the opening diameter of the wiring member is made to be about 7 mm. Then, as shown in Figure 26(a), after inserting the needle-shaped member 101 into the opening of the wiring member 102, in order to reinforce the strength around the opening, a donut-shaped heat-laminated sheet 251a, whose outer diameter is larger than the diameter of the needle-shaped member 101 and whose inner diameter is slightly larger than the diameter of the needle-shaped member 101, is superimposed on the urethane-based sheet 104a side concentric with the opening diameter of the wiring member 102 and heat-laminated. Alternatively, as shown in Figure 26(b), the donut-shaped heat-laminated sheet 251b may have an inner diameter equal to or slightly smaller than the diameter of the needle-shaped member 101, and may be superimposed on the urethane-based sheet 104a side concentric with the opening diameter of the wiring member 102 and heat-laminated.

[0185] As a result, when the needle-shaped member 101 is inserted into the sheet member 104 using an interference fit, the side surface of the needle-shaped member 101 is inserted while prying open the portion of the sheet member 104 that has been opened to a negative tolerance. Consequently, the wiring member 102 is firmly attached to and held in contact with the side surface of the needle-shaped member 101, ensuring stable conductivity.

[0186] Next, the cross-sectional structure around the through member when a donut-shaped heat-laminated sheet 251 is used will be explained with reference to Figures 27(a) and (b). Figure 27(a) shows the cross-sectional structure when a donut-shaped heat-laminated sheet 251a is used in which the inner diameter of the donut-shaped heat-laminated sheet is larger than the diameter of the needle-shaped member 101 or the connecting member 103, and the inner diameter is also slightly larger than the diameter of the needle-shaped member 101 or the connecting member 103. As shown in Figure 27(a), in this case the structure extending outward from the needle-shaped member 101 or the connecting member 103 is, in order from cross-sectional line A to B, the needle-shaped member 101 or the connecting member 103, the wiring member 102, and the urethane-based sheet 104a.

[0187] Figure 27(b) shows the cross-sectional structure when a donut-shaped heat-laminated sheet 251b is used as a donut-shaped reinforcing member, with an inner diameter equal to or slightly smaller than the diameter of the needle-shaped member 101 or the connecting member 103. In Figure 27(b), the degree to which the heat-laminated sheet 251b rises upward depends on how much smaller the inner diameter of the heat-laminated sheet is compared to the diameter of the needle-shaped member 101 or the connecting member 103. However, as shown in Figure 27(b), in this case, the structure extending outward from the needle-shaped member 101 or the connecting member 103 is, in order from cross-sectional line C to D, the needle-shaped member 101 or the connecting member 103, the wiring member 102, the urethane-based sheet 104a, and the heat-laminated sheet 251b.

[0188] (Protective conductive film for wiring members) As shown in Figures 27(c) and (d), a carbon layer 253 can also be applied to the lower layer of the wiring member 102 as a protective conductive film for the wiring member 102. In this case, the structure of cross-sections E to F or G to H will have a carbon layer interposed between the needle-shaped member 101 or connecting member 103 and the wiring member 102 to protect the wiring member 102. Furthermore, by applying a carbon layer to the lower layer of the wiring member 102 to cover the carbon layer 253, the wear resistance of the wiring member 102 is improved, damage during insertion is reduced, and the reliability of conductivity can be further improved.

[0189] Furthermore, suitable materials for the heat-laminated sheet used as a reinforcing member on the side of the needle-shaped member 101 or the side of the connecting member 103 include PET (polyethylene terephthalate), PEN (polyethylene naphthalate), polyethylene, polypropylene, polyimide, urethane, and acrylic. A heat-sealing agent, which is a thermoplastic resin, may also be applied to one side of these materials. This structure enhances the rigidity around the needle-shaped member 101 or the connecting member 103, allowing the electrical connection between the wiring member 102 and the sheet member 104 to remain stable even if some stretching or distortion occurs. The side of the needle-shaped member 101 without the needles (i.e., the upper surface) and the upper surface of the connecting member 103 are left open.

[0190] [Fourteenth Embodiment] (Upper Cover Sheet Made of Elastic Material) Next, the fourteenth embodiment will be described with reference to Figures 28 and 29. The fourteenth embodiment is an embodiment that can be applied in addition to the first to thirteenth embodiments, and differs from the first to thirteenth embodiments in that the side of the needle-shaped member 101 without needles (i.e., the upper surface) and the upper surface of the connecting member 103 are covered with a thermoplastic polyurethane elastomer sheet, which is an elastic material. In the following description, the same or equivalent components as those in the first to thirteenth embodiments described above will be denoted by the same reference numerals, and their descriptions will be simplified or omitted.

[0191] In the 14th embodiment, as shown in Figure 29, in the 13th embodiment, before placing the donut-shaped heat-laminated sheet on top of the urethane sheet 102a, a thermoplastic polyurethane elastomer sheet 403 with an outer diameter larger than the opening diameter of the wiring member 102 is attached to completely close the opening of the sheet member 104. For example, a circularly cut thermoplastic polyurethane elastomer sheet 403 may be heat-laminated concentrically with the opening made in the sheet member 104, or a thermoplastic polyurethane elastomer sheet 403 with an adhesive layer applied to the attachment side may be attached or heat-laminated. In addition to thermoplastic polyurethane elastomer sheets, adhesive thermoplastic polyurethane elastomer sheets, silicone elastomer sheets, acrylic elastomer sheets, etc., can also be selected as the elastomer sheet to be used. Furthermore, the wiring member protective conductive film described in the 13th embodiment may be placed in the lower layer of the wiring member 102.

[0192] Next, the needle-shaped member 101 is inserted into the sheet member 104 using an interference fit. At this time, a hot press machine with an opening larger than the diameter of the needle-shaped member 101 is used to insert the needle-shaped member 101 while prying open the portion of the sheet member 104 that has been opened to a negative tolerance on its side. In order to reinforce the strength of the area around the insertion, a heat-laminated sheet 251a or heat-laminated sheet 251b may be used as a donut-shaped reinforcing member as described in the 13th embodiment. As a result, the wiring member 102 adheres firmly to the side of the needle-shaped member 101 and is held securely, ensuring stable conductivity.

[0193] This allows us to obtain the cross-sectional shape shown in Figure 28. Since the thermoplastic polyurethane elastomer sheet 403 is an elastic material, when the needle-shaped member 101 is inserted while prying open the opening of the sheet member 104, it deforms into an upward convex shape in accordance with the insertion of the needle-shaped member 101. At this time, an external force 264 is applied to the thermoplastic polyurethane elastomer sheet 403, and as a reaction thereto, stress 263 is generated from the needle-shaped member 101 against the human skin. As a result, the stress 263 has the effect of counteracting the resistance force 262 generated from the human skin, and as a result the performance of the needle tip in penetrating the human skin is improved. Furthermore, since the thermoplastic polyurethane elastomer sheet 403 is also an insulating film, the reliability of the product can be further enhanced.

[0194] (Variations in Cross-Sectional Structure) In Figure 28, an example using the heat-laminated sheet 251a was explained. Next, with reference to Figure 29, the cross-sectional structure when using the heat-laminated sheet 251b or when using the conductive film for protecting the wiring member will be explained. Figure 29 schematically shows the cross-section around the periphery 265 of the through member in Figure 28. Figure 29(a) has the same configuration as shown in Figure 28, with only the vertical lengths of the wiring member 102 and the urethane sheet 104a being different. The vertical lengths of the wiring member 102 and the urethane sheet 104a can be appropriately set according to the size of the openings formed in these members and the height of the needle-shaped member 101.

[0195] Figure 29(b) shows a configuration in which a heat-laminated sheet 251b is used instead of the heat-laminated sheet 251a in Figure 29(a). In Figure 29(b), since the heat-laminated sheet 251b rises almost vertically, the cross-sectional structure from cross-sectional line C to D consists, in order, the needle-shaped member 101 or connecting member 103, the wiring member 102, the urethane-based sheet 104a, and the heat-laminated sheet 251b. Figure 29(c) differs from Figure 29(a) in that a carbon layer 253 is provided below the wiring member 102 as a protective conductive film for the wiring member 102. In this case, the cross-sectional structure from cross-sectional line E to F consists, in order, the needle-shaped member 101 or connecting member 103, the carbon layer 253, the wiring member 102, and the urethane-based sheet 104a. Figure 29(d) shows a configuration in which the heat-laminated sheet 251b is used instead of the heat-laminated sheet 251a in Figure 29(c). Therefore, the cross-sectional structure, from cross-sectional line G to H, that is, from the center outwards, consists in order of needle-shaped member 101 or connecting member 103, carbon layer 253, wiring member 102, urethane-based sheet 104a, and heat-laminated sheet 251b. A distinctive feature is that the side of the needle-shaped member 101 opposite to the side without needles is covered with an elastomer sheet.

[0196] [Fifteenth Embodiment] Next, the fifteenth embodiment will be described with reference to Figures 30 and 31. In the fourteenth embodiment, a donut-shaped heat-laminated sheet 251 was placed on top of the thermoplastic polyurethane elastomer sheet 403, but in the fifteenth embodiment, the heat-laminated sheet 251 is positioned below the thermoplastic polyurethane elastomer sheet 403, which is different from the fourteenth embodiment. In the following description, the same or equivalent components as those in the first to fourteenth embodiments described above are denoted by the same reference numerals, and their descriptions are simplified or omitted. In the fifteenth embodiment, in the step of inserting the needle-shaped member 101 or the connecting member 103 into the sheet member 104 by interference fit, first, in order to reinforce the opening made in the sheet member 104, a heat-laminated sheet 251 with an outer diameter larger than the opening diameter is used. The heat-laminated sheet 251 is pre-laminated onto the sheet member 104 for reinforcement, and then holes are punched out with an opening diameter slightly smaller than the diameter of the needle-shaped member 101 or connecting member 103.

[0197] Next, a thermoplastic polyurethane elastomer sheet 403 with an adhesive layer applied to the attachment side is attached to close the drilled opening, and the through member is inserted into the opening to obtain the cross-sectional structure shown in Figure 30. This structure allows for interference fit connection, similar to Embodiment 14, and the elasticity of the polyurethane elastomer sheet improves the performance when the needle tip penetrates human skin, ensuring stable conductivity. Furthermore, this method also makes it possible to attach an insulating film to the through member, further improving the reliability of the product, and the side of the needle-shaped member 101 opposite the needle is covered with an elastomer sheet with an adhesive layer applied to the attachment side. In Figure 30, an example using a thermal laminate sheet 251b is described. In addition, in the 15th embodiment, it is also possible to reinforce the wiring member 102 by providing a carbon layer 253 below the wiring member 102.

[0198] (Variations in Cross-Sectional Structure) Next, the cross-sectional structure in the 15th embodiment will be described with reference to Figure 31. Figure 31 schematically shows the cross-section near the periphery 265 of the through member in Figure 30. Figure 31(a) shows the cross-sectional structure when a heat-laminated sheet 251a, which is processed into a donut shape with an inner diameter of its opening slightly larger than the diameter of the needle-shaped member 101 or the connecting member 103, is used as the heat-laminated sheet in Figure 30. In this case, from cross-sectional line A to B, that is, from the center outwards, the layers are, in order, the needle-shaped member 101 or the connecting member 103, the wiring member 102, the urethane-based sheet 104a, and the thermoplastic polyurethane elastomer sheet 403.

[0199] Figure 31(b) shows a configuration using the heat-laminated sheet 251b described in Figure 30. In Figure 31(b), since the heat-laminated sheet 251b is positioned almost vertically, the cross-sectional structure, from cross-sectional line C to D, that is, from the center outward, consists in order: through member (needle-shaped member 101 or connecting member 103), wiring member 102, urethane-based sheet 104a, heat-laminated sheet 251b, and thermoplastic polyurethane elastomer sheet 403. Figure 31(c) differs from Figure 31(a) in that a carbon layer 253 is provided below the wiring member 102 as a protective conductive film for the wiring member 102. In this case, the cross-sectional structure, from cross-sectional line E to F, that is, from the center outward, consists in order: through member (needle-shaped member 101 or connecting member 103), carbon layer 253, wiring member 102, urethane-based sheet 104a, and thermoplastic polyurethane elastomer sheet 403. Figure 31(d) shows a configuration in which the heat-laminated sheet 251b is used instead of the heat-laminated sheet 251a in Figure 31(c). Therefore, the cross-sectional structure, from cross-sectional line G to H, that is, from the center outwards, consists in order of through member (needle-shaped member 101 or connecting member 103), carbon layer 253, wiring member 102, urethane-based sheet 104a, heat-laminated sheet 251b, and thermoplastic polyurethane elastomer sheet 403.

[0200] In the first to fifteenth embodiments of the present invention, in order to impart conductivity to the support 101a and the base plane 101b of the needle-shaped member 101, a conductive film is formed on the surface of the resin-molded needle-shaped member 101 by methods such as vapor deposition or sputtering. However, there is a risk of uneven vapor deposition occurring due to the film formation environment and materials used in the vapor deposition or sputtering method. For example, when attempting to form a conductive material film from the needle tip direction of the needle-shaped member 101 by vapor deposition or sputtering, it is easy to form a film on the base plane 101b, but difficult to form a film on the side surface of the support 101a, which may result in a decrease in the compensation for conductivity.

[0201] Thus, when there is a risk of uneven deposition in the conductive state of the needle-shaped member 101 used in the first to fifteenth embodiments, it becomes necessary to ensure its conductivity. Therefore, in the sixteenth and seventeenth embodiments described below, attention is paid to the base plane 101b, which is easy to form a film on, and an electrical connection structure is formed not only on the side surface of the support 101a but also on the wiring member 102 and the base plane 101b. This makes it possible to ensure an electrical connection between the needle-shaped member 101 and the wiring member 102, which are inserted by a fit tolerance of "interlock fit" or "interference fit," even when conductivity is not provided on the side surface of the support 101a.

[0202] Specifically, the connection between the base plane 101b of the needle-shaped member 101 and the wiring member 102 is made by overlapping a conductive thin film, such as a PEDOT-PSS film, to bridge the base plane 101b and the wiring member 102, thereby ensuring conductivity. Furthermore, to achieve stronger conductivity, an anisotropic conductive film 283 can be overlapped, sandwiched in between, and pressed together to improve conductivity.

[0203] Furthermore, the following structures are adopted in the 16th and 17th embodiments. In the 16th embodiment, a thermoplastic resin sheet 281 having a diameter slightly larger than the conductive film 282 is attached concentrically to the conductive film 282, and a sheet is used in which the center is opened to a size smaller than the diameter of the needle-shaped member 101. On the other hand, in the 17th embodiment, a thermoplastic resin sheet 281 having a diameter slightly larger than the conductive film 282 and an opening larger than the diameter of the needle-shaped member 101 is attached concentrically to the conductive film 282, and a sheet is used in which the center is opened to a size smaller than the diameter of the needle-shaped member 101.

[0204] The conductive film 282 and the thermoplastic resin sheet 281 can be bonded by heat lamination or by applying an adhesive layer to the thermoplastic resin sheet 281 beforehand. If an adhesive layer is applied to the thermoplastic resin sheet 281, the anisotropic conductive film 283 can be attached to the adhesive surface before heat bonding, eliminating the need for low-pressure pressing or low-temperature temporary bonding steps performed before heat bonding of the anisotropic conductive film 283. In this case, after attaching the anisotropic conductive film 283 to the adhesive surface, the separator can be easily peeled off and attached to the base plane 101b and the wiring member 102, and high-pressure pressing or high-temperature heat bonding can be easily performed.

[0205] In the conductive film 282, a film formed on a sheet is used, but in the 16th embodiment, it may be laminated by printing on a thermoplastic resin sheet 281. The use of the 16th and 17th embodiments can be flexibly adapted as needed. The 16th and 17th embodiments will be described below.

[0206] [16th Embodiment] First, the 16th embodiment will be described with reference to Figure 32. Figure 32(a) is a cross-section of the 16th embodiment, and Figure 32(b) is a plan view of the needle-shaped member 101 as seen from the needle tip side. The 16th embodiment differs from the first to 15th embodiments in that a conductive film 282 and an anisotropic conductive film 283 are layered on a thermoplastic resin sheet 281, and the conductive film 282 is in contact with the wiring member 102 via the anisotropic conductive film 283, and the conductive film 282 is also in contact with the flat surface 101b at the base of the needle of the needle-shaped member 101 via the anisotropic conductive film 283. However, the 16th embodiment is an embodiment applicable to the first to 15th embodiments. In the following description, the same or equivalent components as those in the first to 15th embodiments described above are denoted by the same reference numerals, and their descriptions are simplified or omitted.

[0207] In the first to fifteenth embodiments, when a conductive material is applied to the surface of the needle-shaped member 101 by metal deposition, sputtering, printing, etc., if the application of the conductive material to the side surface of the needle-shaped member support is incomplete, the conductivity obtained by interference fit may become unstable. Therefore, in order to reinforce the connection by interference fit, in the sixteenth embodiment, as shown in Figure 32(a), a conductive film 282 and an anisotropic conductive film 283 are layered on a thermoplastic resin sheet 281, and the conductive film 282 is in contact with the wiring member 102 via the anisotropic conductive film 283, and the conductive film 282 is also in contact with the base plane 101b of the needle-shaped member 101 via the anisotropic conductive film 283. At this time, the needle-shaped member 101 is positioned so that its tip is exposed, and the bonded portion is further heat-pressed to ensure a stable electrical connection over the entire circumference or a part thereof, while simultaneously making the electrical connection and fixing of the needle-shaped member 101 by interference fit stronger.

[0208] In Figure 28(a), the thermoplastic resin sheet 281, the conductive film 282, and the anisotropic conductive film 283 are layered and overlap, covering the area around the base plane 101b of the needle of the needle-shaped member 101 in a donut shape. In this case, the center of the needle-shaped member 101 is exposed. An adhesive layer can also be provided between the thermoplastic resin sheet 281 and the conductive film 282. If an adhesive layer is provided, a donut-shaped seal with the conductive film 282 and anisotropic conductive film 283 attached to the thermoplastic resin sheet 281 may be prepared in advance and joined by heat compression. As the conductive film 282, thin films of metals such as PEDOT / PSS, gold, silver, platinum, copper, and carbon, or conductive resins can be used, and as the anisotropic conductive film, for example, Anisotropic Conductive Film manufactured by Dexerials, Inc. can be used.

[0209] [17th Embodiment] Next, the 17th embodiment will be described with reference to Figure 33. Figure 33(a) is a cross-section of the 17th embodiment, and Figure 33(b) is a plan view of the needle-shaped member 101 as seen from the entry side. The 17th embodiment differs from the 16th embodiment in that the base plane 101b of the needle of the needle-shaped member 101 is covered only with the anisotropic conductive film 283 and the conductive film 282, and the base plane 101b of the needle of the needle-shaped member 101 is not covered with the thermoplastic resin sheet 281. In the following description, the same or equivalent components as those of the 1st to 15th embodiments described above will be denoted by the same reference numerals, and their descriptions will be simplified or omitted.

[0210] As shown in Figure 33(a), in the 17th embodiment, the layers of the thermoplastic resin sheet 281, the conductive film 282, and the anisotropic conductive film 283 are arranged in a donut shape to cover the periphery of the base plane 101b of the needle-shaped member 101, with the tip of the needle-shaped member 101 protruding. Unlike the 16th embodiment, the portion covering the base plane 101b of the needle-shaped member 101 uses only the anisotropic conductive film 283 and the conductive film 282. This reduces the electrical isolation of the thermoplastic resin sheet, which is an insulator. An adhesive layer can be provided on the conductive film 282 side of the thermoplastic resin sheet 281 as needed. If an adhesive layer is provided, a donut-shaped seal with the conductive film and anisotropic conductive film attached to the thermoplastic resin sheet may be prepared in advance and joined by heat compression. As the conductive film, thin films of metals such as PEDOT / PSS, gold, silver, platinum, copper, and carbon, or conductive resins can be used, and as the anisotropic conductive film 283, for example, Anisotropic Conductive Film manufactured by Dexerials, Inc. can be used.

[0211] While embodiments of this disclosure have been described above, this disclosure is not limited to the embodiments described above, and various modifications are possible without departing from the gist of this disclosure. Furthermore, regarding the materials used in this disclosure, materials used in one embodiment can also be used in other embodiments.

[0212] The following describes possible embodiments of the present invention, but it is not limited thereto.

[0213] (Aspect 1) A bioelectrode device comprising an electrode sheet having an electrode for receiving bioelectrical signals, a wiring member for transmitting the received bioelectrical signals, a sensor module for outputting signals related to the bioelectrical signals to the outside, and a connecting member for connecting the wiring member to the sensor module, wherein the connecting member is inserted into a hole drilled in the wiring member with a fit tolerance of "interlock" or "interference fit", and has a slip-up portion that allows the wiring member to slide up when dragged against the side surface of the connecting member, so that the wiring member and the connecting member are in close contact and fixed.

[0214] (Aspect 2) A bioelectrode device comprising an electrode sheet having an electrode for receiving bioelectrical signals, a wiring member for transmitting the received bioelectrical signals, a sensor module for outputting signals related to the bioelectrical signals to the outside, and a connecting member for connecting the wiring member to the sensor module, wherein the electrode is inserted into a hole drilled in the wiring member with a fit tolerance of "interlock fit" or "interference fit", and the wiring member has a slip-up portion that is pulled up by the side surface of the electrode, so that the wiring member and the electrode are in close contact and fixed.

[0215] (Aspect 3) A biomedical electrode device according to aspect 1 or claim 2, comprising an adhesive sheet that can be attached to a living body in a manner that covers the electrode sheet.

[0216] (Aspect 4) A biomedical electrode device according to aspect 2, comprising an adhesive sheet that can be attached to a living body in a manner that covers the electrode sheet.

[0217] (Aspect 5) A bioelectrode device according to any one of aspects 1 to 4, wherein the electrode sheet has a sheet member that supports the electrode, the wiring member, the sensor module, and the connecting member.

[0218] (Aspect 6) A bioelectrode device according to any one of aspects 1 to 5, wherein the electrode is a needle-shaped member that is brought into contact with a living body to receive bioelectrical signals.

[0219] (Aspect 7) A bioelectrode device in any one of aspects 1 to 5, wherein the electrode sheet has at least one pair of conductive gels that are in contact with a living body and receive bioelectrical signals, and the electrode is a conductive member that receives bioelectrical signals from the conductive gel.

[0220] (Aspect 8) A bioelectrode device according to any one of aspects 1 to 7, wherein the sensor module wirelessly transmits signals related to bioelectrical signals to the outside.

[0221] (Aspect 9) A bioelectrode device according to aspect 3 or aspect 4, wherein the sensor module has a wire that outputs a signal related to a bioelectrical signal to the outside, and the adhesive sheet is capable of fixing a part of the wire to a living body.

[0222] (Aspect 10) A bioelectrode device according to any one of aspects 1 to 9, wherein the electrodes are arranged in multiple pairs and receive bioelectrical signals from multiple locations.

[0223] (Aspect 11) A biomedical electrode device according to any one of aspects 1 to 10, wherein the electrodes are arranged in multiple pairs and include electrodes for receiving bioelectrical signals and electrodes for electrotherapy that conduct electric current in the body.

[0224] (Aspect 12) A biomedical electrode device according to any one of aspects 1 to 11, wherein the wiring member has a meandering pattern.

[0225] (Aspect 13) A bioelectrode device according to aspect 5, wherein the wiring member has a meandering pattern, and the sheet member has slits at any location in the meandering pattern.

[0226] (Aspect 14) A biomedical electrode device according to aspect 3, wherein the electrode is fixed in such a manner that it is held between the wiring member and the adhesive sheet, and the protruding portion of the electrode is exposed through a hole made in the wiring member.

[0227] (Aspect 15) A bioelectrode device according to any one of aspects 3 to 14, wherein the adhesive sheet is porous.

[0228] (Aspect 16) A bioelectrode device according to any one of aspects 3 to 15, wherein the adhesive sheet is printed with conductive ink.

[0229] (Aspect 17) A bioelectrode device according to any one of aspects 3 to 15, wherein the adhesive sheet has a metal foil attached to it.

[0230] (Aspect 18) A biomedical electrode device according to aspect 1 or aspect 2, comprising a photocurable resin that can be attached to a living body in a manner that covers the electrode sheet.

[0231] (Aspect 19) A biomedical electrode device according to aspect 18, wherein the photocurable resin is coated on a PET film.

[0232] (Aspect 20) A bioelectrode device according to aspect 18 or aspect 19, wherein the photocurable resin allows the electrode and the sensor module to be attached to the body separately.

[0233] (Aspect 21) A bioelectrode device according to any one of aspects 1 to 20, wherein the sensor module is arranged on the biological side of the electrode sheet.

[0234] (Aspect 22) A bioelectrode device according to aspect 1 or aspect 2, wherein a donut-shaped thermal laminate sheet is attached around the raised portion of the wiring member.

[0235] (Aspect 23) A bioelectrode device according to aspect 22, wherein the thermal laminate sheet is shifted upward along the shifted portion, and the layer structure in the shifted portion is a wiring member, a urethane sheet, and a thermal laminate sheet, from the center outwards.

[0236] (Aspect 24) A bioelectrode device according to aspect 22 or aspect 23, wherein the wiring member constituting the sliding portion is provided with a carbon layer as a reinforcing layer.

[0237] (Aspect 25) A bioelectrode device according to Aspect 1 or Aspect 2, wherein the upward-sloping portion of the wiring member is covered with a thermoplastic insulating film, and a donut-shaped thermal laminate sheet is attached to the thermoplastic insulating film around the upward-sloping portion.

[0238] (Aspect 26) A bioelectrode device according to aspect 2, wherein an anisotropic conductive film, a conductive film, and a plastic resin sheet are laminated on the flat side of the electrode facing human skin, and the wiring member and the electrode are connected via the anisotropic conductive film and the conductive film.

[0239] (Aspect 27) A biomedical electrode device according to aspect 26, wherein only an anisotropic conductive film and a conductive film are laminated on the surface of the electrode facing the human skin.

[0240] 101...Needle-shaped member, 101a...Support, 101b...Base plane, 101c...Lower plane, 102...Wiring member, 103...Connecting member, 104...Sheet member, 104a...Urethane sheet, 104b...Urethane sheet, 104c...Adhesive layer, 105...Sensor module, 106...Electrode sheet, 107...Adhesive sheet, 107a...Separator film, 108...Wiring reinforcement material, 111...Release film, 112a...Insulating film, 112b...Insulating film, 114...Area for inserting needle-shaped member or conductive member, 115...Area for inserting connecting member, 201...Conductive member, 206...Electrode sheet, 208...Conductive gel, 211...Pore, 221...Sheet, 222...Photocurable resin, 223...Porous film or PET film, 226...Terminal, 231...Light source, 232...Hair, 241...Needle-shaped member 242... Fixing of sensor module or terminal, 243... Wiring, 251... Thermal laminate sheet, 251a... Opening diameter of diameter, 251b... Slightly smaller opening diameter, 253... Carbon layer, 261... Pulling, 262... Resistance force, 263... Stress, 264... External force, 301... Forehead, 302... Gap, 401... Hole diameter, 402... Shaft diameter, 403... Thermoplastic polyurethane elastomer sheet, 405... Sensor module, 406... Female side of electrocardiogram snap, 515... Needle hole, 901... Through hole, 1001... Serpentine pattern, 1002... Slit, 1101... Insulating layer, 1102... Insulating layer, 1201... Part of sensor module, 1202... Mesh pattern, 1210... Entire surface, 1211... Covers only the electrode sheet portion, 1212... Covers only the wiring component portion.

Claims

1. A bioelectrode device comprising an electrode sheet having an electrode for receiving bioelectrical signals, a wiring member for transmitting the received bioelectrical signals, a sensor module for outputting signals related to the bioelectrical signals to the outside, and a connecting member for connecting the wiring member to the sensor module, wherein the connecting member is inserted into a hole drilled in the wiring member with a fit tolerance of "interlock" or "interference fit", and has a slip-up portion that allows the wiring member to slide up when dragged against the side surface of the connecting member, so that the wiring member and the connecting member are in close contact and fixed.

2. A bioelectrode device comprising an electrode sheet having an electrode for receiving bioelectrical signals, a wiring member for transmitting the received bioelectrical signals, a sensor module for outputting signals related to the bioelectrical signals to the outside, and a connecting member for connecting the wiring member to the sensor module, wherein the electrode is inserted into a hole drilled in the wiring member with a fit tolerance of "interlock fit" or "interference fit", and the wiring member has a slip-up portion that is pulled up by the side surface of the electrode, so that the wiring member and the electrode are in close contact and fixed together.

3. A biomedical electrode device according to claim 1 or claim 2, comprising an adhesive sheet that can be attached to a living body in a manner that covers the electrode sheet.

4. A bioelectrode device according to claim 1 or claim 2, wherein the electrode sheet has a sheet member that supports the electrode, the wiring member, the sensor module, and the connecting member.

5. A bioelectrode device according to claim 1 or claim 2, wherein the electrode is a needle-shaped member that is brought into contact with a living body to receive bioelectrical signals.

6. A bioelectrode device according to claim 1 or claim 2, wherein the electrode sheet has at least one pair of conductive gels that are in contact with a living body and receive bioelectrical signals, and the electrode is a conductive member that receives bioelectrical signals from the conductive gels.

7. A bioelectrode device according to claim 1 or claim 2, wherein the sensor module wirelessly transmits signals related to bioelectrical signals to an external source.

8. A bioelectrode device according to claim 3, wherein the sensor module has a conductor that outputs a signal related to a bioelectrical signal to the outside, and the adhesive sheet is capable of fixing a portion of the conductor to a living body.

9. A bioelectrode device according to claim 1 or claim 2, wherein the electrodes are arranged in multiple pairs and receive bioelectrical signals from multiple locations.

10. A biomedical electrode device according to claim 1 or claim 2, wherein the electrodes are arranged in multiple pairs and include electrodes for receiving bioelectrical signals and electrodes for electrotherapy that conduct electric current in the body.

11. A biomedical electrode device according to claim 3, wherein the adhesive sheet has a metal foil attached to it.

12. A biomedical electrode device according to claim 1 or claim 2, comprising a photocurable resin that can be attached to a living body in a manner that covers the electrode sheet.

13. A biomedical electrode device according to claim 12, wherein the photocurable resin is coated on a PET film.

14. A bioelectrode device according to claim 1 or claim 2, wherein a donut-shaped thermal laminate sheet is attached around the raised portion of the wiring member.

15. A bioelectrode device according to claim 14, wherein the thermal laminate sheet is shifted upward along the shifted portion, and the layer structure in the shifted portion is a wiring member, a urethane-based sheet, and a thermal laminate sheet, from the center outwards.

16. A bioelectrode device according to claim 14, wherein the wiring member constituting the slip-up portion is provided with a carbon layer as a reinforcing layer.

17. A bioelectrode device according to claim 1 or claim 2, wherein the upward-slip portion of the wiring member is covered with an elastic insulating film, and a donut-shaped thermal laminate sheet is attached to the thermoplastic insulating film around the upward-slip portion.

18. A bioelectrode device according to claim 2, wherein an anisotropic conductive film, a conductive film, and a plastic resin sheet are laminated on the flat side of the electrode facing human skin, and the wiring member and the electrode are connected via the anisotropic conductive film and the conductive film.

19. A biomedical electrode device according to claim 18, wherein only an anisotropic conductive film and a conductive film are laminated on the surface of the electrode facing the human skin.

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