Biological electrode device

Abstract

The purpose of the present invention is to provide a structure of a low-resistance electrode sheet, which reduces noise caused by a torque by strengthening the fixation of the skin to an electrode and a sensor module, and reduces the feeling of wearing by a subject when the electrode sheet is attached to the subject. Therefore, this electrode device for a living body is provided with an electrode sheet and an adhesive sheet that can be attached to the living body so as to cover the electrode sheet. The electrode sheet has: at least one pair of electrodes for receiving a bioelectrical signal; a wiring member for transmitting the received bioelectrical signal; a sensor module for outputting a signal relating to the bioelectrical signal to the outside; a connection member for connecting the transmitted bioelectrical signal to the sensor module; and a sheet member of the wiring member, the sensor module, and the connection member.

Description

Technical Field

[0001] The present invention relates to an electrode device for a living body. Background Art

[0002] Nowadays, medical treatment is highly developed, and it is possible to understand the patient's condition by analyzing the patient's blood, saliva, urine and other body fluids. For example, there are studies on determining the presence of tooth decay by measuring the pH of saliva, and diagnosing diabetes by measuring the blood sugar level of tears. These tests are performed, for example, by the patient collecting body fluids themselves, and then having the body fluids measured and analyzed by medical institutions.

[0003] On the other hand, devices are being developed that allow patients to measure and analyze body fluids themselves without having to go to a medical institution. This not only speeds up the examination and analysis, but can also be used as a measure to reduce medical costs in an aging society, as described below.

[0004] Generally, when you realize that you are in poor health, you go to a medical institution for a diagnosis. However, at this stage, there are cases where late-stage symptoms appear. In such cases, you will need to undergo intensive medical treatment and take expensive drugs, which will increase your medical expenses.

[0005] If poor health conditions are detected early, they may be cured with mild treatments that do not require medication, etc., by changing lifestyle habits. For this reason, the number of institutions that provide regular physical examinations as preventive medicine organized by health insurance associations has begun to increase.

[0006] However, since regular physical examinations are generally performed once or twice a year, there is a blank period between examinations, and diseases that develop during this period cannot be discovered. This has limitations in current preventive medicine.

[0007] If a device that can measure and analyze body fluids without going to a medical institution can be used, examinations can be performed more frequently. Therefore, changes in physical conditions can be discovered before the patient becomes aware of them. Therefore, the need for intensive medical treatment and the administration of expensive drugs is reduced, and medical costs can be reduced.

[0008] As a method for obtaining body fluid information, there is a method of attaching a biosensor to the skin and mucous membrane to obtain internal environment information in a living body (in vivo). According to this method, biosensors can be obtained without time lag, but since the sensor is in direct contact with the organism, the influence on the organism is large, and the device needs to have high reliability.

[0009] There are many methods for biosensing detection, but in the determination of blood sugar levels, the electrochemical method is widely used because it can detect trace components with high sensitivity. In the electrochemical method, since biological information with chemical characteristics can be detected in the form of electrical signals, it has the advantage of being easy to process and analyze the signals obtained using semiconductor devices, etc. Therefore, the development of new electrochemical sensing detection devices and sensing detection methods using the same is actively being carried out all over the world.

[0010] On the other hand, a needle-shaped member having one or more tiny needle-shaped protrusions (e.g., microneedles) that can pierce the skin is attached to the epidermis of a living body and penetrates the stratum corneum of the outermost layer of the skin to supply medicine to the living body or to draw blood from the living body. A variety of sizes and shapes have been proposed for the needle-shaped member, and it is expected to be a non-invasive drug administration method and inspection method.

[0011] By using a needle-like member, puncturing the lower layer of the stratum corneum, i.e., the epidermis layer, and then the dermis layer below it, the tip of the needle-like member reaches these layers, and these layers can be acted on. In addition to supplying medicines or drawing blood from a living body, it is also proposed that: by using the needle-like member (or probe) as an electrode, applying an electrical signal, and receiving a response, information about the lower layer of the skin can be obtained, and a voltage can be applied between the electrodes to allow the drug to penetrate.

[0012] For example, the following Patent Documents 1 and 2 describe technologies related to a biological sensing device using a needle-shaped member.

[0013] Patent document 1 discloses a medical device for diagnosing skin diseases of a subject. The medical device has a conductive probe having a plurality of electrodes, and each electrode has a plurality of microneedles. In this case, each electrode has a base substrate formed of a silicon substrate. The microneedles are integrally formed with the substrate, and are arranged with a spacing therebetween in the lateral direction, and have a length sufficient to penetrate the stratum corneum. The microneedles are formed in a shape that is at least partially inclined. In addition, the invention described in patent document 1 relates to an arrangement of electrodes and microneedles used in the device, and a diagnostic method for a biological state using impedance measurement. The diagnostic method particularly relates to cancer, preferably basal cell carcinoma, malignant melanoma, squamous cell carcinoma, i.e., skin cancer, or a precursor of such a lesion.

[0014] Patent Document 2 discloses a biological monitoring device, which uses a microneedle and a flexible interface, and discloses technologies related to electrocardiogram, sleep evaluation, sleep bruxism evaluation, sleep apnea, and traumatic brain injury.

[0015] Although it is the direction of recent biological monitoring, in brain wave measurement, if the pre-measurement treatment such as removing the cuticle of the subject is not carried out, the contact impedance between the skin and the electrode cannot be reduced, and the biological electrical signal with improved accuracy cannot be obtained. This is accompanied by psychological stress and physical stress of the subject who wants to find the signs of diseases such as dementia and epilepsy early, and no good countermeasures have been found so far. If the psychological stress and physical stress can be reduced as much as possible, there is the advantage of being able to perform stress-free brain wave monitoring simply and with high precision. In addition, if electrodes can be directly and more easily configured in the stratum corneum and subcutaneous muscle layer, it is possible to perform biological monitoring of brain waves, etc., while timely implementing treatments such as electrotherapy that reversely flows current from the electrodes and confirming the effects.

[0016] Prior art literature

[0017] Patent Literature

[0018] Patent Document 1: Japanese Patent No. 5001950

[0019] Patent Document 2: Japanese Patent No. 6606067 Summary of the invention

[0020] Problems to be solved by the invention

[0021] When measuring biological electrical signals in the skin, noise is sometimes generated in the measured waveform. Due to the influence of noise, the waveform that was originally expected to be seen becomes difficult to see, which sometimes has an adverse effect on the measurement. It is believed that the cause of the noise is the resistance of the stratum corneum of the skin, so it is sought to reduce the resistance caused by the stratum corneum. In addition, noise is also generated when the biological electrical signal obtained from the skin is transmitted from the electrode to the sensor module at its front end, due to the torque generated by human movement and poor connection or poor sealing between the sensor module and the electrode, so how to make the skin fit tightly with the electrode and the sensor module is also a problem.

[0022] Patent Document 2 and the like adopt a rivet-type bolt form (button top and rivet head are connected to each other) according to the generally considered form. In the rivet-type bolt form, the electrode in contact with the skin is attached to a substrate with an adhesive layer or adhesive, conductive gel, etc. that adheres to the skin, and a sensor module is arranged on the non-skin side of the attached substrate, that is, on the surface of another substrate without an adhesive layer or adhesive, conductive gel, etc., and the rivet-type bolt is arranged in a manner that penetrates the thickness of the substrate in order to seek electrical conduction with the sensor module. In this way, it is easy to replace the used and discarded mounted electrode patches and sensor modules.

[0023] However, the easy loading and unloading of the electrode patch and the sensor module means that the fixation of the electrode patch and the sensor module is unstable. When there is shaking of the sensor module, the risk of noise generation increases. Even if it is not a rivet-type bolt, the style with the position of the electrode in contact with the skin and the position of the sensor module away from the skin surface according to the thickness of the substrate makes the sensor module easy to vibrate due to the torque, and the risk of noise generation is high.

[0024] In addition, it is understood that if sensor modules, electrodes, wiring, etc. are mixed on both sides of the substrate by adopting rivet-type bolts, the cost of rivet-type bolts, laminated materials, and manufacturing processes increases, which becomes a major disadvantage when the goal is to use a disposable surface-mount type.

[0025] In addition, from the perspective of wearability, although electrodes and modules must be attached to human skin, more firmly attached makes the wearer feel stronger, that is, the discomfort increases. Therefore, alleviating this discomfort is also a problem.

[0026] That is, in order to solve these problems, an electrode sheet with the following performance is desired: even if the resistance caused by the stratum corneum can be reduced by configuring the above-mentioned needle-shaped electrode or the conductive probe with multiple electrodes, the biological electrical signals taken out from the needle-shaped electrode or the conductive probe with multiple electrodes can be transmitted to the sensor module in a low-resistance state, and the multi-point measurement required for brain wave measurement can be easily performed. At the same time, the sweat generated between the skin after the electrode is attached to the subject and the interface of the attached electrode, the elastic follow-up with the skin, and the sense of integration with the sensor module can be solved. Such an electrode sheet is still under development.

[0027] In particular, if a low-cost electrode sheet is to be produced, mass productivity must be considered, and wiring from needle-shaped electrodes and conductive probes having multiple electrodes to the sensor module has to rely on printing technology using conductive pastes such as silver, carbon, and PEDOT.

[0028] However, if a so-called stretchable printed wiring with low resistance is used, the printing height that can be printed on a wiring has a limit, and the printed line width must be expanded to maintain the low resistance wiring. Therefore, although there is no problem as long as the biological electrical signal is detected by a small number of electrodes and transmitted to the module, if the electrode sheet used for multi-point measurement required for brain wave measurement is studied, the electrode sheet will have a large area due to the large printed line width. For example, it can be expected that the electrode sheet will not stick to the forehead of the subject no matter how hard you try, and sweat will be generated at the interface with the skin due to the large area, causing discomfort.

[0029] Furthermore, although it is a needle-shaped electrode, the overall size of the needle-shaped electrode is only several millimeters for ease of processing, and there are also problems such as difficulty in embedding the needle-shaped electrode in the electrode sheet and difficulty in maintaining conductivity on the electrode sheet.

[0030] The present invention is completed to solve the above-mentioned problems, and its purpose is to provide a low-resistance electrode sheet structure, and at the same time reduce the noise caused by torque by strengthening the fixation between the skin, the electrode and the sensor module, and reduce the wearing feeling of the subject when attaching the electrode.

[0031] Means for solving problems

[0032] In order to solve the above-mentioned problems, a representative electrode device for a living body of the present invention comprises an electrode sheet and an adhesive sheet that can be attached to the living body in the form of covering the electrode sheet, and the electrode sheet has: at least one pair of electrodes for receiving biological electrical signals, a wiring member for transmitting the received biological electrical signals, a sensor module for outputting signals related to the biological electrical signals to the outside, a connecting member for connecting the transmitted biological electrical signals to the sensor module, and a sheet member for supporting the electrodes, the wiring member, the sensor module and the connecting member.

[0033] Effects of the Invention

[0034] According to the present invention, a low-resistance electrode sheet structure can be provided, and noise caused by torque can be reduced by strengthening the fixation between the skin, the electrode, and the sensor module, while also reducing the wearing feeling of the subject when attaching the device.

[0035] Other problems, structures, and effects than those described above will become more apparent from the following description of the embodiments for carrying out the invention. BRIEF DESCRIPTION OF THE DRAWINGS

[0036] Figure 1 It is a diagram showing an electrode sheet according to the first embodiment.

[0037] Figure 2 It is a diagram showing an electrode sheet according to a second embodiment.

[0038] Figure 3 The figure shows an electrode patch attached to the forehead of a subject.

[0039] Figure 4 It is a diagram showing an interference fit.

[0040] Figure 5 This is a diagram showing the method of installing the first embodiment on a subject.

[0041] Figure 6 This is a diagram showing a method of installing the third embodiment on a subject.

[0042] Figure 7 This is a diagram showing a conventional wearing method.

[0043] Figure 8 This is a diagram showing a conventional wearing method.

[0044] Fig. 9 It is a diagram showing an electrode sheet according to a fourth embodiment.

[0045] Fig.10 It is a diagram showing an electrode sheet according to a fifth embodiment.

[0046] Fig.11 It is a diagram showing an electrode sheet according to a sixth embodiment.

[0047] Fig.12 It is a diagram showing an electrode sheet according to the seventh embodiment.

[0048] Fig.13 This is a diagram showing the process of removing the mold frame after the wiring member is printed.

[0049] Fig.14 This is a diagram showing a process of forming through holes using a punch or a perforator after printing the wiring member.

[0050] Fig.15 It is a diagram showing an electrode sheet according to the eighth embodiment.

[0051] Fig.16 It is a diagram showing a manufacturing process of an electrode sheet according to the eighth embodiment.

[0052] Fig.17 It is a diagram showing a manufacturing process of an electrode sheet according to the eighth embodiment.

[0053] Fig.18 It is a diagram showing a manufacturing process of an electrode sheet according to the eighth embodiment.

[0054] Fig.19 It is a diagram showing electrodes involved in the eighth embodiment.

[0055] Fig. 20 It is a diagram showing electrodes involved in the ninth embodiment.

[0056] Fig.21 It is a diagram showing an electrode sheet according to the eighth embodiment.

[0057] Fig. 22 It is a diagram showing an electrode sheet according to a tenth embodiment.

[0058] Fig.23 It is a diagram showing an electrode sheet according to a tenth embodiment.

[0059] Fig.24 It is a schematic diagram of an electrode sheet according to the eleventh embodiment.

[0060] Fig.25 It is a schematic diagram of electrode fixation of an electrode sheet according to the eleventh embodiment.

[0061] Fig.26 It is a schematic diagram of the module or terminal fixation of the electrode sheet involved in the eleventh embodiment. DETAILED DESCRIPTION

[0062] Hereinafter, the embodiments of the present invention will be described with reference to the accompanying drawings. It should be noted that the present invention is not limited by the embodiments. In the description of the accompanying drawings, the same parts are marked with the same symbols.

[0063] This embodiment has a structure in which a conductive electrode and a sensor module for directly or indirectly extracting an electrical signal generated by a living body are brought into close contact with human skin.

[0064] In this embodiment, the electrode and sensor module are arranged and installed on the same surface of the electrode sheet or on one side of the electrode sheet, and can be fixed with an adhesive sheet in a state where the electrode and sensor module are in contact with the skin surface. In addition, it is possible to reduce materials and manufacturing processes by installing on one side, thereby reducing costs.

[0065] like Figure 1 As shown, it is characterized in that it has a needle-shaped member 101 composed of at least one pair of electrode groups that contact with a biological body and receive biological electrical signals, a wiring member 102 that transmits the received biological electrical signal voltage, and a connecting member 103 connected to a sensor module 105 that outputs the biological electrical signal voltage to the outside. The electrode sheet 106, which is a whole of the needle-shaped member 101, the wiring member 102, the insulating film 108, the connecting member 103, the sheet member 104 and the sensor module 105, is fully covered by the topmost adhesive sheet 107 to be adhered to the skin and supported, so that the needle-shaped member 101 and the sensor module 105 are in contact with the biological body, and at least the wiring member, the sheet member, and the topmost adhesive sheet are stretchable and elastic.

[0066] Specifically, in Figure 1 In the electrode sheet 106 shown, two connecting members 103 protrude from the sensor module in a bilaterally symmetrical manner. The voltage of the biological electrical signal received from the needle-shaped member 101 is connected to each of the two connecting members via the wiring member 102, and the voltage obtained by the sensor module is received. The more the path from the needle-shaped member 101 to the sensor module in this reception is integrated with the skin of the biological body, the more the noise caused by the shaking and trembling of the sensor module caused by the movement of the biological body can be suppressed.

[0067] Therefore, in order to make the sensor module 105 and the needle-shaped member 101 close to the skin, Figure 1 The electrode sheet 106 is formed in such a manner that the tip of the needle-shaped member 101 and the sensor module 105 are located close to the skin surface, and after being attached to the skin surface of the living body, an adhesive sheet is attached to the reverse side of the tip of the needle-shaped member 101 and the sensor module 105 in a state of covering the electrode sheet 106 and the sensor module 105 as a whole. With regard to the area ratio of the adhesive sheet to the electrode sheet 106 and the sensor module 105 at this time, when the area occupied by the electrode sheet 106 and the sensor module 105 is set to 1, the area of ​​the adhesive sheet is preferably 5 to 6 or more, thereby achieving stable fixation of the electrode sheet 106 and the sensor module 105.

[0068] (Needle-shaped component)

[0069] The needle-shaped member 101 may be a needle-shaped member that has conductivity itself, or the entire surface of the needle-shaped member may be coated with a conductive layer.

[0070] In the needle-shaped member 101, the needle-shaped protrusion (hereinafter referred to as "needle") is arranged in a manner to press the patient's skin or to be able to pierce therein. The applied pressure or piercing reduces the electrical resistance of the skin. In the needle-shaped member 101, the needle having a cross section of the order of several tens of μm is arranged in a manner to be able to pierce into living tissue without causing much trauma.

[0071] The needle-shaped member 101 preferably has a support 101a for arranging the needle. In addition, the needle-shaped member 101 preferably has a plurality of needles protruding above the support 101a, preferably having a length ranging from 50 microns to 300 microns, and preferably having an outer diameter ranging from 10 microns to 250 microns at the periphery of the needle. Regarding the length of the needle and the outer shape range of the needle periphery, depending on the fixing method of the needle-shaped member 101, the length of the needle may be insufficient, and may have a length of more than 300 microns, for example, more than 800 microns, and the outer shape range of the needle periphery accompanying it may also be more than 250 microns.

[0072] The needle of the needle-like member 101 can take a variety of shapes and forms. For example, the distal end can be pointed or not pointed, and can take a beveled shape, a parabolic shape, a flat top, a pointed top, a not pointed top, a rounded top, a tapered shape, and / or a tapered conical shape. The needle-like member can also be provided in a multi-dimensional array, as opposed to an instrument having a single needle or needles forming a single row.

[0073] The needle-shaped member 101 can include a form that combines the area, direction, height or other parameters of the needle. For example, with respect to the conductive layer, the larger its surface area, the more the effective surface area as an electrode increases accordingly, thereby being able to reduce the resistance of the skin. In addition, if the needle-shaped member 101 is easy to penetrate into the skin and the resistance is easy to reduce, it is also possible to find a way to reduce the area of ​​the conductive layer. As the thickness of the conductive layer, it is preferably about 0.05μm to 5μm. If it is thinner than this range, the conductivity cannot be ensured, and if it is thicker than this range, there is a concern that the adhesion with the substrate is damaged.

[0074] The needle-shaped member 101 can be made by making small mechanical structures from metals, polymers and other materials using known microfabrication techniques based on the following approach: the established methods used to make integrated circuits, electronic packages and other microelectronic devices are supplemented with additional methods used in the field of microfabrication.

[0075] As the micro-machining processes that can be used to make the needle-shaped component 101 disclosed in this specification, there are listed: photolithography, etching technology 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 evaporation (filament, electron beam, flash and shadow step coverage), sputtering, chemical vapor deposition (CVD), epitaxy (gas phase, liquid phase and molecular beam), electroplating, screen printing, bonding, photoforming, laser processing and laser ablation (including projection ablation).

[0076] The needle-shaped member 101 can be made of a conductive material belonging to the following range. As such conductive materials, metals, ceramics, semiconductors, organic matter, polymers and composite materials can be listed, but they are not limited to these materials. As preferred materials, nickel-titanium alloy, medical 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 can be listed. Regarding polymers, specifically, highly conductive PEDOT:PSS (a composite composed of poly (3,4-ethylenedioxythiophene) (PEDOT) and polystyrene sulfonic acid (PSS)) can be listed. As an ideal embodiment, a material that is both a conductive material and a biocompatible material is used, such as nickel-titanium alloy, titanium or medical stainless steel, silver / silver chloride, silver chloride.

[0077] In addition, with needle-shaped member 101 as master, the molded product of needle-shaped member 101 can be made by the transfer molding technology via the replica. As an example of molding method, thermal transfer molding, soft photolithography molding and injection molding can also be adopted. In addition, by applying the above-mentioned conductive material, the substrate passes through the transfer molding, and the surface also can obtain the conductive needle-shaped member. About the molded product of the needle-shaped member obtained by transfer molding, preferably select from the polymer that has guaranteed biosafety aspect puncture skin. For example, polycarbonate, polystyrene, epoxy resin, polyethylene, polymethyl methacrylate, polyethylene glycol acid etc. can be used.

[0078] In addition to the needle-shaped member 101 illustrated above, the needle-shaped member 101 can also have an axis with a circular cross section when viewed vertically, or the cross section can also be non-circular. For example, the cross section of the needle-shaped member can also be a polygon (such as a star, square, triangle, circle), elliptical or other symmetrical or asymmetrical shapes, or more than these, the structure of the needle-shaped member can also include a pseudo-pyramid (a shape similar to a pyramid in which the top of the pyramid is made more pointed or a part is recessed), a cone, a polyhedron, a pyramid (pyramid), and a prism (prism).

[0079] In most embodiments, it is preferred that the needles are oriented perpendicularly or at another angle relative to the support 101a. In order to increase the density of needles per unit area of ​​the support 101a, it is preferred that the needles are oriented perpendicularly to the support 101a. However, it is preferred that the needles include a combination of various orientations, various heights, or other parameters of the needles. In addition, the length of the needles may be the same or different between the needles.

[0080] The needles may also have a specific needle density (the number of needles in a specific area). For example, the useful range of the distance between the needles is preferably 100 to 1400 microns, and more preferably 100 to 400 microns. The outer diameter and the length of the needles are also important. In combination with the distance between the needles, it is very important whether the needles actually pierce the stratum corneum of the skin. As an example of an embodiment, the needles have at least about 10 / cm 2 , more preferably at least about 200 to 2000 strands / cm 2 Furthermore, these needle densities help to even out the depth of needle penetration in the skin.

[0081] In this embodiment, in order to be able to fit the contour shape of a biological barrier such as skin close to the needle-shaped member, it may also have flexibility. Assuming that the puncture of the skin is limited due to the deviation of the mounting surface of the biological electrode, for example, the surface of human skin is not flat due to wrinkles and body hair, which becomes a reason for limiting the puncture of the skin. The so-called flexibility can be a deformation of more than 0.1mm and less than 5mm when a load of 4kgf is applied to both ends of the range of 1cm.

[0082] (Conductive member)

[0083] The conductive member used in this embodiment can be used at a low price when the needle-shaped member is expensive. The needle-shaped member directly punctures the skin to obtain the biological electrical signal, but the conductive member is loaded in the electrode sheet 106 in a form of partial replacement with the needle-shaped member, and the conductive gel containing electrolyte is sandwiched between the skin and the conductive member to obtain the biological electrical signal.

[0084] The conductive component can be made of a conductive material belonging to the following range. As such conductive materials, metals, ceramics, semiconductors, organic matter, polymers and composite materials can be listed, but they are not limited to these materials. As preferred materials, nickel-titanium alloy, medical 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 can be listed. Regarding polymers, specifically, highly conductive PEDOT:PSS (a composite composed of poly (3,4-ethylenedioxythiophene) (PEDOT) and polystyrene sulfonic acid (PSS)) can be listed. As an ideal embodiment, a material that is both a conductive material and a biocompatible material is used, such as nickel-titanium alloy, titanium or medical stainless steel, silver / silver chloride, silver chloride.

[0085] (Wiring components)

[0086] The structure of the wiring member involved in the biological electrode of this embodiment is described in detail. The wiring member in this embodiment is formed by using a screen printing method. This screen printing method is described in detail in the specification and drawings of the applicant's earlier application, namely Japanese Special Application No. 2021-105169. However, this embodiment can also be implemented by a printing method other than a screen printing method such as a rotary screen printing method, or a screen printing method other than the printing method shown in the specification of Japanese Special Application No. 2021-105169.

[0087] The screen printing method involved in the formation of wiring components for electrodes for a biological body in this embodiment is realized this time by the following technology: it excels in printing with a high aspect ratio (thick printing thickness) and adopts the features shown in the specification of an earlier application, namely, Japanese Patent Application No. 2021-105169, namely, a technology for simultaneously filling the via and printing wiring with a high aspect ratio.

[0088] The wiring member that can be used in the present embodiment is a wiring member that is printed using a coating agent containing an incompatible additive to a mixture of a filler and a binder (main agent) and a main solvent that is a solvent for the binder as printing ink.

[0089] In the present embodiment, inorganic fillers and organic fillers can be used as fillers that can be used in the wiring member. Inorganic fillers are classified into metal and non-metal. Organic fillers are mainly polymer compounds.

[0090] Among the metals, there are precious metals and base metals. For example, among the precious metals, there are gold, silver, platinum, and palladium. Among the base metals, there are 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. In particular, gold, silver, and copper are useful in this embodiment. Nonmetals are elements other than the metals. For example, in the classification based on reactivity, reactive nonmetals include hydrogen, carbon, nitrogen, oxygen, fluorine, phosphorus, sulfur, chlorine, bromine, selenium, iodine, and astatine. Inert gases include helium, neon, argon, krypton, xenon, and radon. Semimetals having chemical properties like nonmetals include boron, silicon, germanium, arsenic, antimony, and tellurium.

[0091] However, inorganic fillers may also contain substances formed by chemical bonding of multiple elements, such as calcium carbonate, silica, carbon black, graphite, carbon nanotubes, aluminum oxide, aluminum nitride, boron nitride, beryllium oxide, barium titanate, lead zirconate titanate, ferrite, CMC (carboxymethyl cellulose), titanium oxide, glass beads, magnesium oxide, hydrotalcite, barium sulfate, titanium oxide, zinc oxide, iron oxide, calcium oxide, magnesium oxide, zeolite, calcium oxide, magnesium oxide, etc.

[0092] As organic fillers, i.e., polymer compounds, there are linear polymer compounds and network-like polymer compounds, etc. The linear polymer compounds are formed in a filament or chain shape by chemical reactions such as addition polymerization, condensation polymerization, addition condensation polymerization, and covalent bonding by bonding the inorganic fillers in a one-dimensional structure. The network-like polymer compounds have a structure formed by bonding in a three-dimensional structure by covalent bonding, etc.

[0093] The inorganic filler used in the wiring components is an inorganic compound formed by chemical bonding of copper, silver, silicon, etc. with oxygen, hydrogen, carbon, etc., and refers to an inorganic compound with metal atoms having electrical and thermal conductivity as the base axis, and inorganic compounds having siloxane bonds, etc. are particularly preferred.

[0094] As organic fillers, the following can be used: polymers having carbamate bonds, such as polyurethane, which are usually polyurethane resins having carbamate (-NH·CO·O-) bonds, which are generated by addition polymerization of compounds having isocyanate groups and hydroxyl groups; or synthetic resins formed by polymers of acrylates or methacrylates, such as polyurethane rubber acrylic resins; polymer compounds having amide bonds (the same bonds as proteins); high-conductivity polymer compounds such as PEDOT:PSS (a composite composed of poly(3,4-ethylenedioxythiophene) (PEDOT) and polystyrene sulfonic acid (PSS)), etc.

[0095] The shape of the filler is spherical, flat, needle-like, polygonal, etc., and the particle size is preferably 0.1 μm to several tens of μm.

[0096] Adhesives that can be used for wiring members include thermosetting resins, photocurable resins, and thermoplastic resins.

[0097] Thermosetting resins are resins in a state before chemical reactions such as addition polymerization, condensation polymerization, addition condensation polymerization, and covalent bonding of the organic filler, and are relatively low molecular weight substances that become high molecular weight three-dimensional cross-linked structures (network structures) by heating, such as phenolic resins, amino resins, unsaturated polyester resins, epoxy resins, and silicone rubbers. After being cured once, they do not soften again even if heated.

[0098] Thermosetting resins have multiple reaction temperature zones from room temperature to high temperature, and react by addition polymerization, condensation polymerization, addition condensation polymerization, covalent bonding, etc. For example, in elastomers such as silicone rubber, polyorganosiloxane (silicone polymer) with siloxane bonds (Si-O-) in which silicon atoms and oxygen atoms are alternately arranged as the polymer skeleton (main chain) is the main raw material, but it can be divided into HTV (High Temperature Vulcanizing rubber), LTV (Low Temperature Vulcanizing rubber), and RTV (Room Temperature Vulcanizing rubber). The curing temperature of HTV is above 140°C, that of LTV is 40-140°C, and that of RTV is 0-40°C, but the boundaries between HTV and LTV have disappeared due to diversification, and in simple terms, they are mostly divided into heat curing and room temperature curing types.

[0099] In addition, according to the properties before curing, it can be divided into solid kneading type (HCR: High Consistency Rubber, high viscosity rubber) and liquid type, and the liquid type includes LSR (Liquid Silicone Rubber, liquid silicone rubber) and RTV product groups. HCR uses a linear rubber with a degree of polymerization in the range of 5000 to 10000. In contrast, liquid silicone rubber (LSR, RTV) uses a linear polymer with a degree of polymerization in the range of 100 to 2000 as the main component. In addition, according to the cross-linking mechanism, it can be classified into peroxide curing, addition reaction curing, and condensation reaction curing.

[0100] The so-called photocurable resin is a resin that is polymerized and cured by light of a specific wavelength. In short, the adhesive is a thermosetting resin, photocurable resin, thermoplastic resin, etc. before the chemical reaction or adhesion and bonding as described above.

[0101] As the adhesive used in the wiring components, the following resins having rubber elasticity and porosity can be applied: block copolymers having urethane bonds, i.e., polyurethane-based thermoplastic elastomers; thermoplastic polyurethanes; thermosetting polyurethane elastomers; polyester-based elastomers; acrylic rubbers; acrylic elastomers composed of polypropylene and polyester as main components; thermoplastic elastomers having block copolymers of methyl methacrylate and butyl acrylate, etc.

[0102] In addition, it is preferred to use a material containing siloxane. Siloxane refers to a polymer formed by alternating bonding of silicon (Si) and oxygen (O), which becomes the main skeleton of organic silicon called siloxane bond. In particular, organic silicon elastomers with siloxane compounds as the skeleton have a higher element that makes the flexibility or stretchability of the electrode more effective.

[0103] The pattern wiring printing ink that can form the wiring member that can be used in this embodiment is defined in a completely different way of thinking from the printing ink used in ordinary printing applications. In ordinary printing inks, materials with a small difference in solubility parameter (SP value) relative to the binder contained in the printing ink are mixed and used. Since two components with a small difference in SP value are easy to mix (high solubility), it is possible to ensure operability during printing, smoothness of the printed material, and adhesion to the printed material.

[0104] However, in this embodiment, unlike the concept of ordinary printing ink, an additive having a large difference in SP value with respect to the inorganic filler or organic filler and / or binder contained in the printing ink is used, and the additive can be caused to ooze out as a lubricant by the filling pressure.

[0105] As mentioned above, when using an organic silicon elastomer with a siloxane compound as a skeleton as a binder for printing ink, it is preferably used as an additive because it is water-insoluble. In addition, since the elastomer has rubber elasticity and porosity, a state is formed in which the water-soluble solvent penetrates and permeates into the porous body. When such a printing ink is used in printing, the additive that is permeated due to the pressure and shear applied to the printing ink seeps out, forming a film on the interface between the plate and the printing ink, which is easy to show lubricity as a lubricant.

[0106] As an example of the composition of the printing ink used in this embodiment, the following composition can be cited: a conductive material such as silver or carbon is included in the filler, an organic silicon polymer is used as a binder, a solvent mainly composed of aliphatic hydrogen or the like is used as a main agent in addition to a main solvent (e.g., chain siloxanes such as dimethylsiloxane, dodecamethylcyclopentasiloxane, cyclic siloxanes such as octamethylcyclononasiloxane) or n-undecane, and an additive is added. In this case, since the binder is not water-soluble, the additive is specified to be water-soluble.

[0107] The printing ink used in this embodiment is described by taking the mixing of rubber (adhesive) and oil (additive) as an example. When rubber (adhesive) and oil (additive) are mixed, the rubber swells. That is, based on the phenomenon that the oil enters between the molecules of the rubber, if the oil (additive) is easy to mix with the rubber (adhesive), the rubber swells, and if it is difficult to mix, the rubber is difficult to swell. Even if the oil enters between the molecules of the rubber (adhesive), it will seep out on the rubber surface under compression or the like.

[0108] That is, when the binder of the printing ink is non-water-soluble, by adding a water-soluble solvent additive, substances with different polarities and substances with large differences in SP values ​​are difficult to mix with each other, thereby forming a state in which the water-soluble solvent, i.e., the additive, oozes out on the surface of the printing ink.

[0109] When the binder of the printing ink is water-soluble, a water-insoluble solvent is used as an additive. Then, based on the same mechanism as above, the water-insoluble solvent seeps onto the surface of the printing ink and acts as a lubricant.

[0110] The main solvent and additive used in the printing ink may be a water-insoluble solvent or a water-soluble solvent. Generally, as a filler and a solvent contained in the printing ink used in the printing method, a composition containing a compound represented by the following structural formula (1) (excluding monohydroxystearic acid) may be used.

[0111] R1-CH2-R2(1)

[0112] (wherein R1 represents a monohydroxyalkyl group, and R2 represents a carboxyl group (C(=O)OH) or an amide group (C(=O)NH2))

[0113] Specific examples of the solvent include n-heptane (SP value: 7.3), 2-(2-ethoxyethoxy)ethyl acetate (SP value: 9.0), ethylene glycol monoethyl ether acetate (SP value: 8.8), n-propanol (SP value: 11.8), 1,2,5,6-tetrahydrobenzyl alcohol (SP value: 11.3), diethylene glycol ethyl ether (SP value: 10.9), 3-methoxybutanol (SP value: 10.9), triacetin (SP value: 10.2), propylene glycol monomethyl ether (SP value: 10.2), cyclopentanone (SP value: 10.0), γ-butyrolactone (SP value: 9.9), cyclohexanone (SP value: 10.1), cyclopentanone (SP value: 10.0), γ-butyrolactone (SP value: 9.9), and cyclohexanone (SP value: 10.1). : 9.9), propylene glycol n-propyl ether (SP value: 9.8), propylene glycol n-butyl ether (SP value: 9.7), dipropylene glycol methyl ether (SP value: 9.7), 1,4-butanediol diacetate (SP value: 9.6), 3-methoxybutyl acetate (SP value: 8.7), propylene glycol diacetate (SP value: 9.6), lactic acid ethyl acetate (SP value: 9.6), ε-caprolactone (SP value: 9.6), 1,3-butanediol diacetate (SP value: 9.5), dipropylene glycol n-propyl ether (SP value: 9.5), 1,6-hexanediol diacetate (SP value: 9.5), dipropylene glycol n-butyl ether (SP value: 9.4), tripropylene glycol methyl ether (SP value: 9.4), tripropylene glycol n-butyl ether (SP value: 9.3), undecane (SP value: 15.8), decane (SP value: 15.8), dodecane (SP value: 16.0), cyclohexanol acetate (SP value: 9.2), diethylene glycol monoethyl ether acetate (SP value: 9.0), ethylene glycol methyl ether acetate (SP value: 9.0), diethylene glycol monobutyl ether acetate (SP value: 8.9), ethylene glycol monobutyl ether acetate (SP value: 8.9), methyl acetate (SP value: 8.8), ethyl acetate (SP value: 8.7), propylene glycol monomethyl ether acetate (SP value: 8.8 ... P value: 8.7), n-propyl acetate (SP value: 8.7), dipropylene glycol methyl ether acetate (SP value: 8.7), 3-methoxybutanol acetate (SP value: 8.7), butyl acetate (SP value: 8.7), isopropyl acetate (SP value: 8.5), tetrahydrofuran (SP value: 8.3), dipropylene glycol methyl n-butyl ether (SP value: 8.0), dipropylene glycol methyl-n-propyl ether (SP value: 8.0), dipropylene glycol dimethyl ether (SP value: 7.9), propylene glycol methyl n-butyl ether (SP value: 7.8), propylene glycol methyl n-propyl ether (SP value: 7.8), dimethylsiloxane (SP value: 7.5), etc.

[0114] In this embodiment, the SP value is only a reference for positioning the selected solvent. What is important is to determine whether the solvent is water-insoluble or water-soluble and to add a combination of solvents that are truly opposite to the main solvent.

[0115] Although it is the definition of water-insoluble and water-soluble, it shows the definition of water-soluble liquids for Class 4 dangerous substances. Class 4 dangerous substances are flammable liquids. In addition, they are divided into (a) substances that dissolve in water (water-soluble) and (b) substances that do not dissolve in water (water-insoluble).

[0116] These are defined in government decrees as follows. A water-soluble liquid is a liquid that maintains a uniform appearance when mixed with an equal volume of pure water at 1 atmosphere and 20°C. A water-insoluble liquid is a liquid other than a water-soluble liquid. When mixed with water, a water-insoluble liquid separates into two layers. If the specific gravity of the liquid is less than that of water, it is located above the water layer. If the specific gravity is greater than that of water, it is located below the water layer, and a water-insoluble layer can be formed. In the case of a water-soluble liquid, it cannot be separated into layers and becomes uniform when mixed. There are also liquids that are slightly soluble in water, such as diethyl ether, a special combustible, and ethyl acetate, a first petroleum, but they are classified as water-insoluble by definition.

[0117] Therefore, if the classification is based on the above definition, the water-soluble solvents are: 2-(2-ethoxyethoxy)ethyl acetate (SP value: 9.0), ethylene glycol monoethyl ether acetate (SP value: 8.8), n-propanol (SP value: 11.8), 1,2,5,6-tetrahydrobenzyl alcohol (SP value: 11.3), diethylene glycol ethyl ether (SP value: 10.9), 3-methoxybutanol (SP value: 10.9), propylene glycol monomethyl ether (SP value: 10.2), γ-butyrolactone (SP value: 9.9), propylene glycol n-propyl ether (SP value: 9.8), dipropylene glycol methyl ether (SP value: 9.7), lact ...3), diethylene glycol ethyl ether (SP value: 11.8), diethylene glycol ethyl ether (SP value: 11.3), diethylene glycol ethyl ether (SP value: 10.9), 3-methoxybutanol (SP value: 10.9), propylene glycol monomethyl ether (SP Acid ethyl acetate (SP value: 9.6), ε-caprolactone (SP value: 9.6), tripropylene glycol methyl ether (SP value: 9.4), tripropylene glycol n-butyl ether (SP value: 9.3), diethylene glycol monoethyl ether acetate (SP value: 9.0), ethylene glycol methyl ether acetate (SP value: 9.0), diethyl acetate (SP value: 9.0), tetrahydrofuran (SP value: 8.3), dipropylene glycol methyl n-butyl ether (SP value: 8.0), dipropylene glycol methyl n-propyl ether (SP value: 8.0), dipropylene glycol dimethyl ether (SP value: 7.9), propylene glycol methyl n-propyl ether (SP value: 7.8).

[0118] The water-insoluble solvents are: undecane (SP value: 15.8), decane (SP value: 15.8), dodecane (SP value: 16.0), triacetin (SP value: 10.2), cyclopentanone (SP value: 10.0), cyclohexanone (SP value: 9.9), propylene glycol n-butyl ether (SP value: 9.7), 1,4-butanediol diacetate (SP value: 9.6), 3-methoxybutyl acetate (SP value: 8.7), propylene glycol diacetate (SP value: 9.6), 1,3-butanediol diacetate (SP value: 9.5), dipropylene glycol n-propyl ether (SP value: 9.5), 1,6-hexanediol diacetate (SP value: 9.5), dipropylene glycol n-butyl ether (SP value: 9.4), cyclohexanol acetate (SP value: 9.2), diethylene glycol monobutyl ether acetate (SP value: 8.9), ethylene glycol monobutyl ether acetate (SP value: 8.9), methyl acetate (SP value: 8.8), ethyl acetate (SP value: 8.7), propylene glycol monomethyl ether acetate (SP value: 8.7), n-propyl acetate (SP value: 8.7), dipropylene glycol methyl ether acetate (SP value: 8.7), 3-methoxybutanol acetate (SP value: 8.7), butyl acetate (SP value: 8.7), isopropyl acetate (SP value: 8.5), propylene glycol methyl n-butyl ether (SP value: 7.8), and dimethylsiloxane (SP value: 7.5).

[0119] When the total weight of the filler and the binder contained in the printing ink used in this embodiment is 100 parts, the filler may be 50 to 99.9 parts. Specifically, the filler and the silver paste, copper paste, etc. used for printing purposes may be used as the main agent.

[0120] The additives in the printing ink are preferably adjusted within a range of 0.1 to 50 parts, based on 100 parts by total weight of the filler and the binder contained in the coating agent.

[0121] In the printing ink used in the present embodiment, there may also be a compatible solvent with good affinity for the adhesive. By having a compatible solvent, the closeness, conductivity, and continuity of the inorganic filler or the mixture of the organic filler and the adhesive (main agent) with the printed object can be ensured. Therefore, the slip property can be obtained while maintaining these properties in their original state. If the added amount is outside the above range, the chemical bonds of the elastomer, etc., which is the main agent, will be damaged and separated, and the property will become physically brittle, and printing will become difficult. Even if printing is possible, sometimes the elastic force is lost, or the conductivity and thermal conductivity are obviously lost.

[0122] The printing ink used in this embodiment is pressurized by the ink scraper when the ink is swept, which causes the lubricant in the coating agent to seep out. Therefore, the peeling of the coating agent from the mask interface is promoted, and the coating agent is transferred to the substrate without cohesion failure, so that a wiring member with a roughly rectangular cross-sectional shape and substantially vertical opposite sides can be obtained. However, in this embodiment, the cross-sectional shape does not necessarily have to be roughly rectangular, and the opposite sides do not necessarily have to be roughly vertical.

[0123] (sheet component)

[0124] A flexible sheet or a stretchable sheet used in a sheet member to be printed with a wiring pattern of the wiring member according to the present embodiment will be described.

[0125] The flexible sheet or stretchable sheet that can be used in this embodiment is made of the following materials: OPP (biaxially stretched polypropylene), CPP (unstretched 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 (polyethylene Alcohol), PVDC (polyvinylidene chloride resin), PC (polycarbonate), POM (polyoxymethylene resin), PBT (polybutylene terephthalate), PTFE (fluororesin), PF (phenolic resin), MF (melamine resin), UF (urea-formaldehyde resin), PUR (polyurethane), EP (epoxy resin), UP (unsaturated polyester resin), PS (polystyrene), KOP (polyvinylidene chloride coated OPP), AL (aluminum foil), AOP (PVA coated OPP / Tohcello), PT glass paper (plain transparent: ordinary glass paper), MST glass paper (moisture proof cellophane: moisture-proof cellophane, PVC-coated), K cellophane (PVDC-coated), VM (aluminum vapor-deposited film, transparent vapor-deposited film), co-extrusion film, non-woven 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 vinyl chloromethyl ether), ANM (acrylic rubber: copolymer of n-butyl acrylate and acrylonitrile), CSM (chlorosulfonated polyethylene rubber), PUR (polyurethane resin), U (polyurethane rubber), Si (silicone resin (organic silicone resin), Q (organic silicone rubber), VMQ (organic silicone rubber with vinyl and methyl groups), SR (organic silicone rubber), FKM (fluororubber, vinylidene fluoride rubber), FPM (fluororubber), EVA (ethylene-vinyl acetate rubber), CO (Epichlorohydrin rubber: homopolymer of epichlorohydrin), ECO (epiochloroether rubber), T (polysulfide rubber), copper foil, etc.The flexible sheet or stretchable sheet can be used in the form of a single-layer or two-layer or more laminated film.

[0126] Furthermore, in the following disclosure, when referring to a flexible sheet, the flexible sheet can be replaced with a stretchable sheet unless there is a special reason. In addition, in the present embodiment, the sheet member 104 can also be in the form of a single layer or a laminated film of two or more layers.

[0127] For example, when the wiring components are pattern-printed with a carbamate-based printing ink, a carbamate-based film can be selected for the printed surface layer, and a PET film, for example, can be selected for the lower layer to make it rigid. A primer or an adhesive layer for improving adhesion can be sandwiched between the carbamate-based film and the PET film. In addition, other types of sheets, primers, and adhesive layers can be arbitrarily stacked on the lower layer of the PET film. When the wiring components are pattern-printed with a silicone-based printing ink, a silicone-based film can be selected for the printed surface layer, and a PET film, for example, can be selected for the lower layer to make it rigid. A primer or an adhesive layer for improving adhesion can be sandwiched between the silicone-based film and the PET film. In addition, other types of sheets, primers, and adhesive layers can be arbitrarily stacked on the lower layer of the PET film.

[0128] A base film necessary for forming the sheet member and a protective film considering handling and antifouling properties during printing may also be provided. The base film may be made of, for example, PET film or polyethylene film without limitation.

[0129] Based on the above-mentioned essentials, a hole punch or a punch is used to punch holes at necessary places in a single-layer or laminated sheet member to form through holes called vias or through holes for inserting and fixing the needle-shaped member 101, the conductive member 201, and the connecting member 103. With regard to the hole, for example, a wiring member can be injected into the hole by the screen printing method of the present invention described later, and a via or through hole having conductivity can be formed.

[0130] The opening diameter of the passage or through hole must tend to be an interference with the diameter of the portion inserted and fixed in the passage or through hole of the needle-shaped member 101, the conductive member 201, and the connecting member 103. In other words, by making the fitting tolerance from "transition fit" or zero tolerance to "interference fit" or negative tolerance with respect to the diameter of the fixed portion of the needle-shaped member 101, the conductive member 201, and the connecting member 103, the shaking of the needle-shaped member 101, the conductive member 201, and the connecting member 103 can be eliminated, and strong conductivity can be ensured. By additionally applying a conductive adhesive in this state, reliability can be further improved.

[0131] The diameter of the passage or through hole may be a diameter obtained by subtracting a ratio of -0% to -99.9% from the diameter of the fixed portion of the needle-shaped member 101, the conductive member 201, and the connecting member 103, or may be further -0% to -40%, or further -0% to -15%. Finally, puncture may be performed by forming the tips of the needle-shaped member 101, the conductive member 201, and the connecting member 103 into a needle shape.

[0132] In particular, the electrical connection with the sensor sheet in the rivet-type bolt form (button top, rivet head connected to each other) and magnet connection used in the connection between the sensor module and the electrode in the past is simple as a general purpose, but it is a major cause of the increase in material cost of the electrode sheet because it is thrown away after use. However, the method of the present invention can achieve the effect of being able to directly insert the connection member 103 of the sensor module into the path or through hole that ensures conductivity, thereby saving materials, and thus it is possible to suppress the unit price of the patch that is thrown away after use.

[0133] (Conductive gel containing electrolyte)

[0134] The conductive gel containing electrolyte used in the present embodiment is formed by adding a polymer material that exerts flexibility, plasticity and adhesion to an electrolyte solution in which at least any one of amino acids, organic salts and inorganic salts is dissolved, and then solidifying into a gel state. As the polymer material that exerts flexibility, plasticity and adhesion, a material having a glass transition temperature below the living temperature and a melting point above the living temperature can be used, for example, acrylic acid and polyurethane polymer materials can be considered. In addition, the so-called "living temperature" in the present embodiment refers to a temperature in the range of 0 degrees to 40 degrees.

[0135] (Insulating film)

[0136] The insulating film that can be used in this embodiment is preferably composed of a material that does not cause strength degradation, deformation, melting, deterioration, etc. within the desired use time. For example, a sheet formed of polyester resins such as polyethylene terephthalate, polybutylene terephthalate, polyethylene naphthalate, ethylene-terephthalate-isophthalate copolymer, and polyarylate can be used, and a non-stretched sheet is preferably used. Alternatively, a resin sheet formed of fluororesins such as polyvinyl fluoride, polyvinylidene fluoride, polytetrafluoroethylene, ethylene-tetrafluoroethylene copolymer, polyimide resin, etc., RTV silicone rubber, UV curing silicone rubber, etc. can also be used.

[0137] These insulating films can be bonded within a desired range by methods such as hot melt bonding, dry lamination, spraying, etc. Alternatively, they can be coated within a desired range by printing methods such as screen printing, gravure printing, flexographic printing, offset printing, and roller transfer printing. Furthermore, as the resin binder of the ink used, for example, acrylic resin, polyester resin, polyimide resin, silicone resin, etc. can be used. Furthermore, the thickness of the insulating coating is usually preferably in the range of 20 to 300 μm.

[0138] (Connecting components)

[0139] The connection member that can be used in this embodiment is basically connected or inserted into the sensor module.

[0140] As raw materials, it can be made of conductive materials belonging to the following ranges. As such conductive materials, metals, ceramics, semiconductors, organic matter, polymers and composite materials can be listed, but they are not limited to these materials. As preferred materials, nickel-titanium alloy, medical 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 can be listed. Regarding polymers, specifically, highly conductive PEDOT:PSS (a composite composed of poly (3,4-ethylenedioxythiophene) (PEDOT) and polystyrene sulfonic acid (PSS)) can be listed. As an ideal embodiment, a material that is both a conductive material and a biocompatible material is used, such as nickel-titanium alloy, titanium or medical stainless steel, silver / silver chloride, silver chloride.

[0141] (Sensor Module)

[0142] In the sensor module 105 used in this embodiment, the connection member may be loaded and fixed inside the sensor module 105, or may be fixed to the electrode sheet 106 side and inserted and connected to the sensor module 105 side. The appearance and function of the sensor module 105 are not particularly limited.

[0143] For example, Figure 5 As shown, when the electrode sheet of this embodiment is worn on a person's forehead, it can have the function of transmitting and receiving signals wirelessly with the sensor module side and a mobile phone, PC, radio wave transceiver base station, etc., or it can also be as shown in FIG. Figure 6 As shown in FIG. 1 , the sensor module 105 is connected to a mobile phone, a PC, a measuring device, etc. by wires. In the former case, a two-dimensional or three-dimensional antenna for radio wave transmission and reception may be included. The antenna may be arranged along the wall of the module shell or buried therein. The antenna may be located inside the module, or an antenna printed on the electrode sheet may be used which is connected to the sensor module 105 via a connecting member as needed.

[0144] This embodiment may also include Fig. 9 The sensor module may include a signal generator and one or more biological amplifiers, wherein the signal generator is configured to provide a signal to two or more electrodes (for example, generally scanning in each of a plurality of frequency ranges such as between 1 Hz and 10 GHz, between 1 kHz and 10 MHz, between 5 kHz and 1 MHz, etc.). The biological amplifier is configured to capture one or more signals from two or more electrodes. The processor, gate array, digital signal processor or related microcircuit is configured to analyze the captured signal and determine the bioimpedance of nearby tissues.

[0145] The bioamplifier is configured to capture bioelectric signals from electrodes (e.g., EKG (Elektro Kardio Gramm), HR (Heart Rate), EMG (Electro Myo Graphy), EOG (Electro Oculo Graphy), EEG (Electro Encephalo Graphy), ERG (Electro RetinoGraphy), etc.). In addition, the sensor module may include a power source (e.g., a primary battery, a secondary battery, an energy harvesting system, etc.). In particular, it would be better if the power source is a flexible thin flexible battery that can be exchanged when the electrode sheet is exchanged and the sensor module is reused. Therefore, each module is preferably a self-powered device. The sensor module may include a processor and an internal power source.

[0146] It can also be Figure 6 The wired connection as shown can reduce the functions of the sensor module 105 and provide functions such as an antenna and a power supply from the outside, thereby reducing the total weight of the electrode sheet 106 and reducing the discomfort of the subject.

[0147] (Uppermost adhesive sheet member)

[0148] The most notable feature of this embodiment is that a pressure-sensitive adhesive sheet is disposed on the uppermost layer.

[0149] Conventional electrode sheets for acquiring biological electrical signals all adopt a method in which the electrode sheet and the sensor module are arranged via a diaphragm and the sensor module is connected to the electrode sheet.

[0150] However, although this is an example, Figure 7 Wireless method and Figure 8 As shown in the wired method, the following problems are listed as the following: when the biological electrical signal obtained from the skin is transmitted from the electrode to the sensor module at the front end, the torque generated by the human movement and the poor connection or poor fit between the sensor module and the electrode, as well as the positional relationship, increases, and noise is easily generated. In addition, most of the methods are in the form of taking out the lead wire from the electrode sheet and connecting it to the sensor module by folding it back, and the electrode sheet and the sensor module are installed separately multiple times.

[0151] Therefore, this embodiment has conducted intensive research to solve these problems, and as a result, a method of attaching an adhesive sheet on the top layer in a form that completely covers the electrode and the sensor module is adopted. That is to say, when the electrode sheet is characterized by having a sensor module on the same surface formed by the needle-shaped member 101, the conductive member 201 and the wiring member 102 for extracting the biological electrical signal, when the wire is taken out of the sensor module, the wire is also fixed with an adhesive sheet, thereby seeking to reduce noise. As a result, the needle-shaped member 101 and the sensor module are in direct contact with the biological surface, and the moment generated by the positional relationship between the electrode and the sensor module can be suppressed to a minimum. The basic size of the adhesive sheet member is specified to be about 150 mm horizontally and 50 mm vertically, even if it is a large size, and its shape can be changed arbitrarily.

[0152] In addition, conductive ink can be printed on the pressure-sensitive adhesive sheet, and patterns for electromagnetic shielding and decoration purposes can be printed or metal foil can be laminated.

[0153] In addition, the pressing force of the needle-shaped member and the conductive member on the skin also increases.

[0154] The adhesive sheet is composed of a substrate / adhesive, and the adhesive is applied on the electrode and module fixing side. The thickness of the substrate / adhesive composition can be greater than 10 μm and less than 200 μm. The substrate contains a polyurethane resin, and may also contain at least one selected from an ether polyurethane resin, an ester polyurethane resin, and a carbonate polyurethane resin, and the thickness is preferably greater than 5 μm and less than 30 μm.

[0155] The adhesive is preferably formed of a synthetic resin and is preferably formed of a polyurethane-based adhesive. The thickness of the adhesive layer is preferably 5 μm or more and 25 μm or less.

[0156] The tensile elongation at break of the laminated adhesive sheet is preferably 130% or more, and the tensile stress at 100% elongation is preferably 10 to 100 MPa, more preferably 10 to 30 MPa. As long as it is within this range, it has the effect of being suitable for following the unevenness of the biological surface during biological patching, the expansion and contraction of the biological surface, etc. In addition, the moisture permeability is preferably 2000 g / m 2·day or more, as long as it is within this range, it has the effect of transpiration caused by biological skin respiration, water vapor, and sweating. The adhesive sheet can also be porous. In addition, it is also possible to cut or open holes at any position around the sensor module and the electrode sheet for the purpose of further improving the air permeability and removing the air around the sensor module and the electrode sheet.

[0157] Furthermore, the adhesive sheet may be made of a silicone-based material as long as the same effect can be obtained.

[0158] [Evaluation method]

[0159] [Tensile elongation at break]

[0160] The tensile elongation at break was measured by the method based on "Plastics - Test methods for tensile properties - Part 3: Test conditions for films and sheets" of JIS K7127: 1999 (ISO 527-3: 1995) and "Plastics - Methods for determining tensile properties - Part 1: General" of JIS K7161-1: 2014 (ISO 527-1: 2012). When measuring the tensile elongation at break, the adhesive sheet was demolded in a dumbbell shape (test piece type 5), and the tensile strength at break was measured using a tensile testing machine (AGS-X 5kN manufactured by Shimadzu Corporation). The test speed was set to 300 mm / min, the distance between the markings L0 was set to 25 mm, and the initial distance between the clamps L was set to 80 mm. In the case where the test piece has no yield point, the tensile stress at break is calculated as the tensile elongation at break. On the other hand, in the case where the test piece has a yield point, the tensile nominal stress at break is calculated as the tensile elongation at break. In addition, when measuring the tensile elongation at break, the measurement was performed on a laminate consisting only of a substrate and an adhesive.

[0161] [Tensile stress at 100% elongation]

[0162] As in the case of measuring the tensile elongation at break, a test piece was prepared in accordance with "Plastics - Test methods for tensile properties - Part 3: Test methods for films and sheets" of JIS K7127:1999 (ISO 527-3:1995). Then, the tensile stress at 100% elongation was calculated as the stress when the deformation reaches 100% in accordance with "Plastics - Methods for determining tensile properties - Part 1: General" of JIS K7161-1:2014 (ISO 527-1:2012).

[0163] (Sheet coated with photocurable resin)

[0164] The most characteristic feature of this embodiment is that an adhesive sheet is arranged on the top layer, but it is found that a dry fixing method is also effective for solving the problem of the present invention by using a sheet coated with a photocurable resin instead of the adhesive sheet of the top layer, curing it by light irradiation while keeping the skin, electrodes and sensor modules in close contact. Although the method of attaching it to the skin of the subject in the form of covering the electrode sheet and the sensor module as a whole is adopted, a sheet coated with a photocurable resin on a porous film or PET film can also be used instead of the adhesive sheet 107.

[0165] Photocurable resin refers to a photopolymerizable resin, and may be a composite material (synthetic resin) mixed with bisphenol A glycidyl methacrylate adduct (Bis-GMA), triethylene glycol dimethacrylate (TEGDMA), urethane dimethacrylate (UDMA), other diacrylates, triacrylates, monomers, mixtures, inorganic fillers such as quartz, silicon nitride, glass, organic composite fillers containing organic matter, etc., and the light source for curing it may be a halogen lamp, a xenon lamp, a UV lamp, a visible light LED, a UV light LED, etc. A sheet coated with a photocurable resin on a porous film or a PET film is attached to the forehead, head, top of the head, body, hands, and feet instead of the adhesive sheet 107 of this embodiment, and the photocurable resin is cured and adhered by irradiating the light source for several seconds to several tens of seconds, and the hair is caught, thereby showing an anchoring effect, and achieving dry attachment to the subject.

[0166] After signal measurement is completed, the thin film of photocurable resin can be broken with fingertips to remove the electrode sheet without causing excessive pain during peeling.

[0167] <Electrode Sheet>

[0168] Hereinafter, the electrode sheet involved in the present embodiment example is described through a plurality of embodiments. However, it is needless to say that the present invention is not limited by these embodiments. In addition, in the description of the accompanying drawings, the same symbols are marked for the parts that are the same or equivalent to the structures already described, and the description thereof is simplified or omitted.

[0169] [First embodiment]

[0170] Figure 1 1 is a diagram showing an electrode sheet according to the first embodiment. Hereinafter, the first embodiment will be described in terms of its manufacturing procedure.

[0171] First, as a substrate used in the first embodiment, Figure 1The substrate has a silicone sheet 104a attached to the upper layer, an adhesive layer 104b attached to the middle layer, and a PET film 104c attached to the lower layer. In this embodiment, the silicone sheet 104a, the adhesive layer 104b, and the PET film 104c in the attached state are collectively referred to as a sheet member 104.

[0172] Next, through holes with a diameter of 3 mm are punched at four locations with a punch to insert the needle-shaped member 101 and the connecting member 103. The distance between the centers of the through holes punched at four locations is arranged at equal intervals of 20 mm, 20 mm, and 20 mm in a straight line. In this embodiment, a PET film is used, but in order to adapt to the wiring formation environment such as thermal shrinkage, the above-mentioned materials such as polyethylene naphthalate, polyurethane sheet, and polyimide sheet can also be used.

[0173] Then, if Fig.13 As shown in the figure, in order to make the arrangement of the four through holes on the sheet member 104 that are evenly spaced at straight lines of 20 mm, 20 mm, and 20 mm by a punch, four metal cylinders with a diameter of 2.5 mm and a metal plate that is flatly bonded to the bottom surface of the cylinder are overlapped so that the center of the through hole with a diameter of 3 mm coincides with the center of the cylinder with a diameter of 2.5 mm. The metal cylinder with a diameter of 2.5 mm can be inserted into the through holes formed on the sheet member 104 that are evenly spaced at straight lines of 20 mm, 20 mm, and 20 mm by a punch. The height of the cylinder coincides with the height of the through hole of the sheet member 104.

[0174] The combination of the cylinder and the metal plate is generally referred to as a mold frame. In this embodiment, a metal mold frame is used, but engineering plastics such as polypropylene, polyethylene, polyimide, epoxy resin, acrylic resin, silicone, fluororesin, polyurethane resin, and UV curing resin may also be used.

[0175] Next, the wiring component 102 is printed by excelling at the printing method used in this embodiment, i.e., printing with a high aspect ratio, and adopting the features shown in the specification of the earlier application, i.e., Japanese Patent Application No. 2021-105169, i.e., technology for simultaneously filling the via and printing wiring with a high aspect ratio.

[0176] The technology shown in the specification of Japanese Special Application No. 2021-105169 is: while printing a wiring pattern using a conductive coating agent on a sheet to be printed having through holes (holes) extending toward the surface side and the back side, a conductive coating agent is injected into the through holes (holes), and the surface side and the back side of the sheet are connected by the conductive coating agent, thereby forming a conductive sheet on the surface and back side of the sheet.

[0177] Through the above printing, the conductive paste is simultaneously printed and filled in the gap between the through hole with a diameter of 3 mm and the cylinder with a diameter of 2.5 mm formed on the mold frame. The through hole is opened with a punch to insert the wiring with a high aspect ratio, the needle-shaped component 101 and the connecting component 103.

[0178] Next, the film was dried in a thermostatic chamber at 160° C. and the surface was plasma treated. Then, PVC silicone rubber was sprayed as an insulating film and dried.

[0179] Next, remove the mold frame from the sheet. Fig.13 This is a diagram showing the process of removing the mold frame after the wiring member is printed.

[0180] As a method of forming the through-holes other than the mold frame, a method using a punch or a piercer may be used. Fig.14 This is a diagram showing the process of forming a through hole using a punch and a punch after printing the wiring member. As a result, a film of a conductive coating agent is formed in a cylindrical shape on the wall surface of the through hole, so that an effect of facilitating electrical connection can be obtained when the needle-shaped member 101 and the connecting member 103 in the subsequent process are filled with an interference fit.

[0181] Next, the needle-shaped member 101 is loaded. Since the support 101a must have a large diameter interference fit with the through-hole filled with the conductive coating agent, a needle-shaped member 101 with a support diameter of 3 mm is selected.

[0182] The needle-like member 101 is sucked with suction tweezers in a manner that does not damage the needle tip, and is vertically loaded into the through hole with an interference fit. The conduction check using a tester confirms that the electrode sheet 106 and the support body 101a of the needle-like member 101 are completely integrated.

[0183] Through the series of steps up to this point, the sensor module 105 and the electrode sheet other than the connecting member 103 are completed.

[0184] Next, a cylindrical connection member 103 with a diameter of 3 mm and a height of 2 mm prepared in advance and integrated with the sensor module 105 are loaded in the electrode sheet 106 .

[0185] The two connecting members 103 are easily connected to the remaining two through holes of the electrode sheet 106 by interference fit.

[0186] (Interference fit)

[0187] Interference fit means: Figure 4In the embodiment, the through hole diameter 401 and the shaft diameter 402 of the support body 101a of the needle-shaped member 101 are inserted in a state in which the shaft diameter > the hole diameter. The elastic force of the elastic body, i.e., the electrode sheet 106 and the conductive wiring member 102 of this embodiment can achieve the effect of firmly fixing the needle-shaped member 101 and the connecting member 103 by interference fit. This relationship is sometimes usually expressed as "interference amount" or "fit tolerance", but since the difference in diameter between the shaft and the hole, i.e., the fit tolerance, varies depending on the material of the sheet, etc., it cannot be specified here, but the hole diameter is specified to be 0 to negative (smaller) than the diameter of the support body 101a.

[0188] Next, prepare an adhesive sheet 107 with an adhesive layer coated on the protective film on the back and the mounting surface 109 of the electrode sheet 106, and mount the electrode sheet 106 at the center of the adhesive sheet 107 on the adhesive layer side of the adhesive sheet in such a way that the PET film 104c is integrated.

[0189] Then, if Figure 3 As shown in the figure, the electrode sheet is evenly attached to the center of the forehead 301 of the subject, and the protective film on the surface of the adhesive sheet is peeled off. As a result, the adhesive sheet is arranged on the top layer of the present embodiment, and the style of covering the electrode sheet and the entire sensor module is completed. A gap 302 can also be formed to some extent in the interface between the forehead 301, the sensor module 105, the electrode sheet 106 and the adhesive sheet 107, and the sense of unity with the forehead 301 of the subject is maintained by covering the electrode sheet 106 and the sensor module 105 with the adhesive sheet over a large area. In addition, by maintaining the sense of unity, the needle of the needle-shaped member 101 can be stably inserted into the stratum corneum of the forehead 301 of the subject.

[0190] Specifically, the method for stably inserting the needle of the needle-shaped member 101 is as follows: the sensor module 105 is arranged at the center of gravity of the adhesive sheet, that is, the center, and the electrode sheet 106 forms a state of the expanded blade of the wiring member 102 symmetrically with respect to the center of gravity (center) of the sensor module, and the needle-shaped member 101 is filled at a position far away from the connecting member 103 of the sensor module 105 by 2 cm or 3 cm instead of 1 cm, so that the influence of the gap 302 of the adhesive sheet occurring around the sensor module 105 can be avoided, and the needle can be stably inserted. Therefore, by making the gap 302 of the adhesive sheet smaller in the height from the mounting surface of the sensor module 105 2 mm or 1 mm instead of 3 mm, the needle of the needle-shaped member 101 can be stably inserted.

[0191] In the first embodiment, the quality evaluation of the signal that can be obtained through the connecting member 103 was performed. The purpose is to determine how close the contact impedance transmitted from the needle-shaped member 101 of this embodiment to the connecting member 103 can be compared with the medical needle electrode used in the medical field.

[0192] Therefore, two NE224S electrodes manufactured by Nihon Kohden and the electrode sheet 106 of the present embodiment were prepared, mounted on skinned chicken (thigh), and measured by a two-terminal method using an impedance measuring device (ZM2376 manufactured by NF Circuit Design Co., Ltd.). The measured resistance values ​​were 2.2KΩ (0.5Hz), 0.7KΩ (30KHz), and 1.0KΩ near 100Hz in the medical needle electrode, while the maximum resistance value was 6.2KΩ (0.5Hz), the minimum resistance value was 3.5KΩ (30KHz), and the resistance value near 100Hz was 4.2KΩ in the electrode sheet 106 of the present embodiment. By the way, two medical gel electrodes (Vitrode F manufactured by Nihon Kohden) using electrolyte were also measured under the same conditions, and the maximum resistance value was 727KΩ (0.5Hz), the minimum resistance value was 2.7KΩ (30KHz), and the resistance value near 100Hz was 101KΩ.

[0193] As a result, the results of the two-terminal method of the three electrodes showed that the needle electrode had the smallest resistance value, and the electrode sheet of this embodiment had a slightly larger resistance value than the needle electrode, but still much smaller than the gel electrode. The central frequency of the biological electrical signal measurement is in the range of 1Hz to 200Hz, but up to around 100Hz, the resistance value of the electrode sheet of this embodiment is still much lower than that of the gel electrode.

[0194] Therefore, it is determined that the electrode sheet of this embodiment is an effective electrode.

[0195] [Second embodiment]

[0196] Figure 2 1 is a diagram showing an electrode sheet according to the second embodiment. Hereinafter, the second embodiment will be described in terms of its manufacturing procedure.

[0197] First, as a substrate used in the second embodiment, Figure 2 The substrate has a silicone sheet 104a attached to the upper layer, an adhesive layer 104b attached to the middle layer, and a PET film 104c attached to the lower layer. In this embodiment, the silicone sheet 104a, the adhesive layer 104b, and the PET film 104c in the attached state are collectively referred to as a sheet member 104.

[0198] Next, through holes with a diameter of 3 mm were punched at four locations to insert the conductive member 201 and the connecting member 103 .

[0199] Next, a metal cylinder with a diameter of 2.5 mm and a metal plate flatly bonded to the bottom surface of the cylinder are superimposed so that the center of the through hole with a diameter of 3 mm coincides with the center of the cylinder with a diameter of 2.5 mm. The height of the cylinder coincides with the height of the through hole of the sheet member 104.

[0200] The combination of the column and the metal plate is generally referred to as a mold frame. The metal plate can also be made of stainless steel, nickel, copper, aluminum, iron oxide, graphite, etc.

[0201] Next, the wiring component 102 is printed by excelling at the printing method used in this embodiment, i.e., printing with a high aspect ratio, and adopting the features shown in the specification of the earlier application, i.e., Japanese Patent Application No. 2021-105169, i.e., technology for simultaneously filling the via and printing wiring with a high aspect ratio.

[0202] Through the above printing, the conductive paste is simultaneously printed and filled in the gap between the through hole with a diameter of 3 mm and the cylinder with a diameter of 2.5 mm formed on the mold frame. The through hole is opened with a punch to insert wiring with a high aspect ratio, the conductive component 201 and the connecting component 103.

[0203] Next, the film was dried in a thermostatic chamber at 160° C. and the surface was plasma treated. Then, PVC silicone rubber was sprayed as an insulating film and dried.

[0204] Next, remove the mold frame from the sheet. Fig.13 This is a diagram showing the process of removing the mold frame after the wiring member is printed.

[0205] As a method of forming the through-holes other than the mold frame, a method using a punch or a piercer may be used. Fig.14 This is a diagram showing a process of forming through holes using a punch and a perforator after printing a wiring member.

[0206] Next, the conductive member 201 is loaded. However, since the support 201a must have a large diameter and an interference fit with the through-hole filled with the conductive paste, a conductive member 201 having a support diameter of 3 mm is selected.

[0207] The conductive member 201 is sucked by suction tweezers and vertically loaded into the through hole according to interference fit, and it is confirmed that the electrode sheet 106 and the support body 201a of the conductive member 201 are completely integrated.

[0208] Through the series of steps up to this point, the sensor module 105 and the electrode sheet other than the connecting member 103 are completed.

[0209] Next, a cylindrical connection member 103 and a sensor module 105 prepared in advance with a diameter of 3 mm and a height of 2 mm are integrated and loaded into the electrode sheet 106 .

[0210] The two connection members 103 are easily connected to the remaining two through holes of the electrode sheet 206 by interference fit according to the method of the first embodiment.

[0211] Next, the conductive gel 208 is attached so as to cover the entire exposed surface of the conductive member 201 .

[0212] Next, prepare an adhesive sheet 107 with an adhesive layer coated on the protective film on the back and the mounting surface 109 of the electrode sheet 206, and mount the electrode sheet 106 at the center of the adhesive sheet 107 on the adhesive layer side of the adhesive sheet in such a way that the PET film 104c is integrated.

[0213] Then, if Figure 3 As shown, the electrode sheets are evenly attached to the center of the forehead 301 of the subject, and the protective film on the surface of the adhesive sheet is peeled off, resulting in a pattern in which the adhesive sheet is arranged on the top layer of the present embodiment to cover the electrode sheets and the entire sensor module.

[0214] If the first embodiment is positioned as a high-priced method, this embodiment is a low-cost method.

[0215] Since a conductive gel is used, the performance is inferior to that of the first embodiment, but the greatest feature of this embodiment is that, finally, a structure is adopted in which the entire surface is covered with an adhesive sheet, so the wearability of the electrode and sensor module is excellent compared to the accuracy of the contact impedance.

[0216] Regarding the wearability in the first and second embodiments, the presence or absence of discomfort of the subject when the sensor module is taken out of the adhesive sheet and when the sensor module of this embodiment is included in the adhesive sheet, and the change in the resistance value measured by the connection part were confirmed.

[0217] Of course, regarding the discomfort of the subject, it is needless to say that the sense of unity of the present embodiment is superior, and regarding the change in resistance value, the present embodiment is also smaller.

[0218] [Third Embodiment]

[0219] Following the content of evaluating the quality of the signal that can be obtained by the connection member 103 using skin-on chicken (thigh) in the first embodiment, as a wired method of connecting an impedance measuring device (ZM2376 manufactured by NF Circuit Design Co., Ltd.) to the sensor module with a wire, the wire was shaken at 1 Hz and an amplitude of 20 cm. As a result, the biological electrode device of this embodiment showed almost no noise, and the maximum resistance value was 6.2 KΩ (0.5 Hz), the minimum resistance value was 3.5 KΩ (30 KHz), and the resistance value near 100 Hz was 4.2 KΩ. If the sensor module is connected to the outside and the wire is shaken in the same way, extreme noise will appear and measurement cannot be made.

[0220] That is, the lead wire can be partially fixed in a state where the electrode sheet and the entire sensor module are covered with the adhesive sheet. This is considered to be directly related to the presence or absence of noise, which shows the effectiveness of this embodiment.

[0221] From this, it can be considered that the low-cost method using the conductive gel of the second embodiment is also the same.

[0222] Figure 5 and Figure 6 The first and third embodiments of the method of installing the device on a subject are shown in FIG. Figure 7 and Figure 8 Based on the above, it is believed that even if the chicken (thigh) is replaced by a human body, the effect of this embodiment is not reduced and is superior to the previous installation method.

[0223] [Fourth embodiment]

[0224] Fig. 9 The embodiment of obtaining the biological electrical signal of the electrode sheet involved in the first embodiment at more than two places, i.e., multiple places at the same time is shown. Alternatively, the embodiment of the electrode that also has the function of obtaining the biological electrical signal while simultaneously flowing current for electrical treatment is shown. The basic manufacturing method is the same as the first embodiment, but the first embodiment forms two pairs of the needle-shaped member 101 and the connecting member 103 by opening through holes at four places, while the present embodiment forms four pairs of the needle-shaped member 101 and the connecting member 103 by opening eight through holes. Of course, more through holes can be opened, and thus, for example, the brain wave measurement points can also be specified as multiple points. However, the more points are specified, the larger the wiring area occupied by the electrode sheet, so the through holes 901 that are not used for measurement can also be opened between the wiring of the electrode sheet at various places. This can reduce the discomfort caused by the steaming heat at the interface between the skin of the subject and the electrode sheet.

[0225] This embodiment can also be applied to the second embodiment and the third embodiment. For example, current may flow through the needle-shaped member based on the biological electrical signal obtained by the conductive gel and the conductive member of the second embodiment. In this case, the wired method of the third embodiment can further improve the effect.

[0226] [Fifth embodiment]

[0227] In the first to fourth embodiments, as Fig.10 In this way, the pattern of the wiring member 102 may also be formed in a zigzag shape. For example, it may be a continuous wiring in a regular and accurate zigzag shape. When the wiring member 102 is formed on a flexible and stretchable substrate to make an electrode sheet, if there is a possibility of noise due to the movement of the subject and the fluctuation, expansion and contraction, vibration, etc. of the mounting surface, it may be formed Fig.10 The zigzag pattern 1001. In order to provide a more flexible device, a slit 1002 may be formed in the electrode at any position of the zigzag pattern.

[0228] [Sixth embodiment]

[0229] In the first to fifth embodiments, the sheet member 104 may be a single-layer or a laminated sheet of two or more layers. In the first to fifth embodiments, a structure using a PET substrate mainly in a three-layer structure is shown. As a general performance, the PET substrate has high rigidity compared with elastomeric materials such as silicone sheets, which have a tensile strength of 48MPa to 73MPa, a break elongation of 30 to 300%, and a tensile elastic modulus of 2800MPa to 4200MPa in ASTM standard D638. Therefore, by using such a raw material in a part of the sheet member 104, the advantage that can be obtained is that sensitive biological electrical signals such as brain waves can be obtained without much distortion. From the first to fifth embodiments, the structure is assumed to obtain such an effect.

[0230] However, with the recent development of measurement and analysis software, for example, even if the deformation caused by an elastomer such as a silicone sheet increases, the distortion of the resulting bioelectrical signal becomes larger. If a functional expression for the change in the bioelectrical signal, such as the contact resistance value, relative to the expansion and contraction rate and deformation rate of the elastomer used can be established in the software, sufficient measurement can be performed even if the layer structure of the sheet member 104 is only an elastomer.

[0231] For example, Fig.11In this way, the sheet member 104 can also be formed by laminating the adhesive sheet 107 and a thin film (elastomer material 1101) such as a silicone sheet, or directly applying the elastomer on the adhesive sheet 107 by screen printing or the like. When the thin film is laminated, there is a tendency that the adhesion with the adhesive sheet 107 becomes weak due to the relationship of surface energy, so a primer and adhesive 1102 that can strengthen the adhesion with the adhesive sheet 107 can be applied to the lower layer of the film. In addition, when the elastomer is directly applied by printing or the like, the primer may be applied to the adhesive sheet 107 in advance, or it may not be applied.

[0232] [Seventh embodiment]

[0233] In the first to sixth embodiments, the adhesive sheet 107 is attached to the skin of the subject in the form of covering the electrode sheet and the entire sensor module as in the above-mentioned embodiment. Of course, all or part of the data of the biological electrical signal obtained by the sensor module can be transmitted by radio waves, but it is assumed that the radio waves transmitted from the sensor module, the radio waves intruding from the outside, and the electromagnetic waves also have an impact on the electrode sheets 106 and 206.

[0234] Therefore, on the adhesive sheet 107, conductive ink can be used and the entire surface or mesh pattern can be printed by inkjet in a manner that at least covers the sheet member 104 without covering a portion of the sensor module. The so-called entire surface, in printing terms, refers to a state of 100% full coating. The mesh pattern takes into account permeability, moisture permeability, design, etc. The entire surface can also be printed on the adhesive sheet 107 using conductive ink to print patterns with design patterns such as patterns and skin colors that appear to be integrated with the skin. These printings are not limited to inkjet, and offset printing, screen printing, gravure printing, flexible printing, dispensers, and 3D printers can also be used. In addition, metal foils such as copper and aluminum that have the same effect can also be attached. This is called so-called electromagnetic shielding.

[0235] This can avoid the phenomenon in which unintended current is induced in the sensor module and the electrode sheet due to transmission and reception between the sensor module and the outside and attack of electromagnetic waves on the electrode sheet. Fig.12 In order to prevent the mesh pattern 1202 from covering a portion 1201 of the sensor module, the entire surface 1210 of the adhesive sheet may be printed without a pattern, or only the electrode sheet portion 1211 or only the wiring member portion 1212 may be printed.

[0236] The mesh pattern tends to be as inconspicuous as possible, and is composed of thin lines with a line width of less than 30μm, preferably less than 15-20μm, and a line thickness of less than 3μm in a lattice with a pitch of 300μm to 500μm. The resulting surface resistivity is less than 40Ω / □, and more preferably less than 1.2Ω / □.

[0237] [Eighth embodiment]

[0238] In the first to seventh embodiments, the method of ensuring conductivity is to fill the through holes perpendicular to the electrode sheets 106 and 206 by interference fit, and completely integrate the electrode sheet 106 and the support 101a of the needle-shaped member 101 and the support 201a of the conductive member 201 and the connecting member 103. However, as another method of ensuring conductivity, the wiring member 102 and the adhesive sheet 107 are sandwiched in a layer. Fig.15 The upper plane 101b and the lower plane 101c of the support 101a of the needle-shaped member 101 shown in the figure ensure integration and conductivity with the electrode sheet 106. The wiring member mentioned here can also use ink containing silver, copper, carbon filler and conductive polymer such as PEDOT·PSS.

[0239] Regarding the substrate used in the embodiment, Fig.16 In the process, first, the insulating film 112a is printed on the release film 111 outside the range 115 where the connecting member 103 is inserted in the subsequent process. The wiring member 102 is printed thereon. Next, the insulating film 112b is printed outside the range 114 where the needle-shaped member 101 is inserted later. Drying and curing after printing in the above process can be performed at any time.

[0240] Then, if Fig.17 In this way, the hole 211 is penetrated by a punch so that the needle-like member 101 and the connecting member 103 can be inserted.

[0241] Next, regarding the needle-shaped member 101, as shown in FIG. Fig.18 (a) The support body 101a of the needle-shaped member 101 is brought into contact with the wiring member 102, and the needle-shaped member 101 is inserted into the inner side of the hole 211. The wiring member 102 and the needle-shaped member 101 are connected by inserting the needle-shaped member 101, but a conductive adhesive may be applied to the contact portion and its periphery as required.

[0242] Then, if Fig.18 As shown in (b), the adhesive sheet 107 is bonded to the entire surface including the release film 111. The separator 107a is bonded to the adhesive sheet 107.

[0243] Fig.19The figure shows that the needle-shaped member 101 in this embodiment is exposed from the hole 211 when the release film 111 is peeled off, and the needle-shaped member 101 is firmly adhered and fixed to the electrode sheet 106 separated from the release film 111. The figure shows the feature of this embodiment: the needle-shaped member 101 is firmly sandwiched between the printed wiring member 102 and the adhesive sheet 107, and a sense of unity is achieved in the form that only the needle part of the needle-shaped member 101 is exposed from the hole 211. This makes the conduction stronger.

[0244] Through this process, the release film 111, the insulating film 112a, the wiring member 102, the insulating film 112b, the needle-shaped member 101, the adhesive sheet 107, and the separator 107a are formed into an integrated electrode sheet 106. In addition, depending on the handling properties, the packaging capacity, etc., it is not necessary to have a large area sheet, and it can be divided and processed into any shape and size.

[0245] Although the adhesive sheet 107 and the diaphragm 107a used therein, Fig.21 As shown, it is also possible to use an adhesive sheet or separator in which a plurality of pinholes 515 are previously penetrated at arbitrary intervals in a part or the entire surface.

[0246] When the subject inserts the connecting member 103 of the sensor module 105 into the hole 211 of the electrode sheet 106, it is sometimes difficult to accurately insert the connecting member 103 into the diaphragm 107a. Therefore, by having the pinhole 515, the top of the connecting member 103 can break a part of the diaphragm 107a by taking the pinhole 515 of the diaphragm 107a as an opportunity, and can be more closely fitted and contacted with the hole 211. As a result, the conduction from the connecting member 103 to the needle-shaped member 101 can be made more reliable. The advantage of the pinhole 515 is that in the manufacturing process of the adhesive sheet 107, for example, by flowing the adhesive sheet 107 and the diaphragm 107a in a device provided with a calender roller that performs embossing processing like many sharp needles on a continuous production line such as a roll-to-roller, the pinhole 515 can be easily provided.

[0247] The size and number of the pinholes 515 can be changed arbitrarily, and a circular or polygonal opening can be formed instead of a pinhole.

[0248] [Ninth embodiment]

[0249] Fig. 20 The structure is: the conductive member 201 is used instead of the conductive member 201 shown in the eighth embodiment. Fig.19 The needle-shaped member 101 can obtain biological signals not through the needle-shaped member 101 but through the conductive gel 208 containing electrolyte.

[0250] The manufacturing process is similar to the steps shown in the eighth embodiment. On the release film 111, an insulating film 112a is printed outside the range 115 where the connecting member 103 is inserted in the later process. The wiring member 102 is printed thereon. Then, an insulating film 112b is printed outside the range 114 where the conductive member 201 is inserted in place of the needle-shaped member 101. Drying and curing after printing in the above process are performed at any time. Then, as shown in FIG. Fig.17 The hole 211 is punched through with a punch so that the conductive member 201 and the connecting member 103, which replace the needle-shaped member 101, can be inserted. Fig. 20 In this way, the conductive member 201 is in contact with the wiring member 102, and a part of the conductive member 201 is inserted into the inner side of the hole 211. With the conductive member 201 inserted, the wiring member 102 and the conductive member 201 are connected to each other, but a conductive adhesive may be applied to the contact portion and its periphery as needed.

[0251] The subsequent process is the same as that of the eighth embodiment, but in the ninth embodiment, before supplying to the subject side, an additional process is added to peel off the release film 111 once, attach the conductive gel 208 containing electrolyte, and then re-attach the release film.

[0252] [10th embodiment]

[0253] In the first to ninth embodiments, the adhesive sheet 107 is attached to the skin of the subject in a manner covering the electrode sheet 106 and the sensor module 105 as in the above-mentioned embodiment. Fig. 22 As shown, a sheet 221 in which a photocurable resin 222 is applied to a porous film or a PET film 223 is used instead of the adhesive sheet 107 .

[0254] The photocurable resin 222 refers to a photopolymerizable resin, and may also be a composite material (synthetic resin) mixed with bisphenol A glycidyl ether methacrylate adduct (Bis-GMA), triethylene glycol dimethacrylate (TEGDMA), urethane dimethacrylate (UDMA), other diacrylates, triacrylate monomers, mixtures, quartz, silicon nitride, glass and other inorganic fillers, organic composite fillers containing organic matter, etc. The light source for curing may be a halogen lamp, a xenon lamp, a UV lamp, a visible light LED, a UV light LED, etc.

[0255] like Fig.23In this way, a sheet 221 made of a photocurable resin 222 coated on a porous film or a PET film 223 is attached to the forehead, head, top of the head, body, hands, and feet instead of the adhesive sheet 107 of this embodiment. By irradiating the light source 231 for several seconds to several tens of seconds, the photocurable resin is cured and adhered, and an anchoring effect is exhibited by grasping the hair, thereby achieving dry attachment. Furthermore, it is preferred that the light source 231 is pressed against the sheet 221 for irradiation, so that the film thickness of the photocurable resin 222 can be formed into a thin film. Basically, UV-A (wavelength 315 to 400nm) is used. The required cumulative light amount is preferably 1mJ / cm 2 ~4000mJ / cm 2 The range is more preferably 1 mJ / cm 2 ~2000mJ / cm 2 range, but ultimately choose a moderate amount of light taking into account the effect on the human body.

[0256] After signal measurement is completed, the thin film-like photocurable resin can be broken up with the fingertips, and the electrode sheet can be removed in a way that does not cause excessive pain when peeling off.

[0257] The tenth embodiment can be applied to fixation of a bioelectrode device and is particularly effective when a needle-shaped member is used as an electrode.

[0258] [11th embodiment]

[0259] In the first to tenth embodiments, the electrode sheet 106 and the sensor module 105 are all covered. However, by using the photocurable resin of the tenth embodiment, Figure 24 to Figure 26 As shown, by using a sheet 221 in which a photocurable resin 222 is applied to a porous film and a PET film 223, respectively, it is possible to perform fixation 241 of the needle-shaped member and fixation 242 of the sensor module 105 or the terminal 226 in accordance with the tenth embodiment.

[0260] Thus, it is also possible to fix the needle-shaped member to the top of the wiring 243 separately, for example, in a satellite shape, for the measured part where the hair is crowded around the top of the head, unlike the electrode sheet 106 or 206 attached to the forehead. It is also possible to separate from the electrode sheet 106 or 206 attached to the forehead, and only use the part where the needle-shaped member is fixed, for example, in a satellite shape. Thus, the electrode installation at 19 places according to the "10 / 20 method" recommended by the International Electroencephalogram Society can be performed. The 11th embodiment is not limited to the 10th embodiment, and can be applied to the fixing of a biological electrode device. In particular, it is effective when the needle-shaped member is used as an electrode.

[0261] [12th embodiment]

[0262] The tenth embodiment or the eleventh embodiment can be installed on the forehead, head, top of the head, head, body, hands, feet, etc., and can be used as an electrode sheet for electrical treatment.

[0263] As mentioned above, although embodiment of this invention was described, this invention is not limited to the said embodiment, Various changes are possible within the range which does not deviate from the summary of this invention.

[0264] The following description may be a form of the content of the present invention, but it is not limited to this.

[0265] (Form 1)

[0266] A living body electrode device, comprising:

[0267] Electrode pads, and

[0268] An adhesive sheet that can be attached to a living body in the form of covering the electrode sheet,

[0269] The electrode sheet has:

[0270] at least one pair of electrodes for receiving electrical signals from a biological body,

[0271] A wiring member for transmitting the received biological electrical signal,

[0272] A sensor module that outputs signals related to biological electrical signals to the outside, and

[0273] A connecting member connects the transmitted biological electrical signal to the sensor module.

[0274] (Form 2)

[0275] The living body electrode device according to the first aspect, wherein the electrode sheet includes a sheet member that supports the electrode, the wiring member, the sensor module, and the connecting member.

[0276] (Form 3)

[0277] The living body electrode device according to aspect 1 or 2, wherein the electrode is a needle-shaped member that contacts the living body and receives an electrical signal from the living body.

[0278] (Form 4)

[0279] The electrode device for a living body according to the first or second aspect, wherein the electrode sheet has at least one pair of conductive gels that are in contact with the living body and receive electrical signals from the living body,

[0280] The electrode is a conductive member that receives a biological electrical signal from the conductive gel.

[0281] (Form 5)

[0282] The living body electrode device according to any one of aspects 1 to 4, wherein the sensor module wirelessly transmits a signal related to the living body electrical signal to the outside.

[0283] (Form 6)

[0284] The living body electrode device according to any one of the first to fourth aspects, wherein the sensor module has a lead wire for outputting a signal related to the living body electrical signal to the outside.

[0285] The adhesive sheet can fix a portion of the guide wire to a living body.

[0286] (Form 7)

[0287] The living body electrode device according to any one of the first to sixth aspects, wherein the electrodes are arranged in a plurality of pairs and receive living body electrical signals at a plurality of locations.

[0288] (Form 8)

[0289] The living body electrode device according to any one of the first to seventh aspects, wherein the electrodes are arranged in a plurality of pairs, and include electrodes for receiving living body electrical signals and electrodes for electrical treatment for passing current through the living body.

[0290] (Form 9)

[0291] The living body electrode device according to any one of the first to eighth aspects, wherein the wiring member has a zigzag pattern.

[0292] (Form 10)

[0293] The living body electrode device according to any one of the second to ninth aspects, wherein the wiring member has a zigzag pattern,

[0294] The sheet member has slits at arbitrary locations in the zigzag pattern.

[0295] (Form 11)

[0296] According to any one of forms 2 to 10, the electrode is fixed to a portion of the wall surface of a hole opened in the sheet member and covered with the wiring member with a fitting tolerance of "transition fit" or "interference fit".

[0297] (Form 12)

[0298] The living body electrode device according to any one of forms 2 to 11, wherein the connecting member is fixed to a portion of the wall surface of a hole opened in the sheet member and covered with the wiring member with a fitting tolerance of "transition fit" or "interference fit".

[0299] (Form 13)

[0300] The living body electrode device according to any one of the first to tenth aspects, wherein the electrode is held between the wiring member and the adhesive sheet and is fixed in a manner such that a protruding portion of the electrode is exposed from a hole formed in the wiring member.

[0301] (Form 14)

[0302] The living body electrode device according to any one of the first to tenth and thirteenth aspects, wherein the connection member is inserted into and fixed in a hole formed in the wiring member.

[0303] (Form 15)

[0304] The living body electrode device according to any one of the first to fourteenth aspects, wherein the adhesive sheet is porous.

[0305] (Form 16)

[0306] The living body electrode device according to any one of the first to fifteenth aspects, wherein the adhesive sheet is printed with conductive ink.

[0307] (Form 17)

[0308] The living body electrode device according to any one of the first to sixteenth aspects, wherein a metal foil is attached to the adhesive sheet.

[0309] (Form 18)

[0310] A living body electrode device, comprising:

[0311] Electrode pads, and

[0312] A photocurable resin that can be attached to a living body in the form of covering the electrode sheet,

[0313] The electrode sheet has:

[0314] at least one pair of electrodes for receiving electrical signals from a biological body,

[0315] A wiring member for transmitting the received biological electrical signal,

[0316] A sensor module that outputs signals related to biological electrical signals to the outside, and

[0317] A connecting member connects the transmitted biological electrical signal to the sensor module.

[0318] (Form 19)

[0319] The living body electrode device according to the eighteenth embodiment, wherein the photocurable resin is coated on a PET film.

[0320] (Form 20)

[0321] In the living body electrode device according to the eighteenth or nineteenth aspect, the photocurable resin can respectively attach the electrode and the sensor module to the living body.

[0322] (Form 21)

[0323] The living body electrode device according to any one of the eighteenth to twentieth aspects, wherein a part or all of the electrodes are used as electrodes for electrical treatment.

[0324] (Form 22)

[0325] The living body electrode device according to any one of the first to twenty-first aspects, wherein the sensor module is disposed on a surface of the electrode sheet on a living body side.

[0326] Explanation of symbols

[0327] 101-needle-shaped member, 101a-support body, 101b-upper plane, 101c-lower plane, 102-wiring member, 103-connecting member, 104-sheet member, 104a-silicone sheet, 104b-adhesive layer, 104c-PET film, 105-sensor module, 106-electrode sheet, 107-adhesive sheet, 107a-diaphragm, 108-insulating film, 111-release film, 112a-insulating film, 112b-insulating film, 114-range for inserting the needle-shaped member or the conductive member, 115-range for inserting the connecting member, 201-conductive member, 206-electrode sheet, 208-conductive gel, 211-hole, 221-sheet , 222 - photocurable resin, 223 - porous film and PET film, 226 - terminal, 231 - light source, 232 - hair, 241 - fixing of needle-shaped member, 242 - fixing of sensor module or terminal, 243 - wiring, 301 - forehead, 302 - gap, 401 - aperture, 402 - shaft diameter, 515 - pinhole, 901 - through hole, 1001 - zigzag pattern, 1002 - slit, 1101 - elastomer material, 1102 - primer and adhesive, 1201 - part of sensor module, 1202 - mesh pattern, 1210 - whole surface, 1211 - form of only part of electrode sheet covered, 1212 - form of only part of wiring member covered.

Claims

1. A living body electrode device, comprising: Electrode pads, and An adhesive sheet that can be attached to a living body in the form of covering the electrode sheet, The electrode sheet has: at least one pair of electrodes for receiving electrical signals from a biological body, A wiring member for transmitting the received biological electrical signal, A sensor module that outputs signals related to biological electrical signals to the outside, and A connecting member connects the transmitted biological electrical signal to the sensor module.

2. The living body electrode device according to claim 1, wherein: The electrode sheet has a sheet member that supports the electrode, the wiring member, the sensor module, and the connecting member.

3. The living body electrode device according to claim 1, wherein: The electrode is a needle-shaped member that contacts a living body and receives an electrical signal from the living body.

4. The living body electrode device according to claim 1, wherein: The electrode sheet has at least one pair of conductive gels that are in contact with the biological body and receive the biological body's electrical signals. The electrode is a conductive member that receives a biological electrical signal from the conductive gel.

5. The living body electrode device according to claim 1, wherein: The sensor module wirelessly transmits signals related to biological electrical signals to the outside.

6. The living body electrode device according to claim 1, wherein: The sensor module has a wire for outputting a signal related to an electrical signal of a biological body to the outside. The adhesive sheet can fix a portion of the guide wire to a living body.

7. The living body electrode device according to claim 1, wherein: The electrodes are arranged in multiple pairs to receive electrical signals from multiple parts of the biological body.

8. The living body electrode device according to claim 1, wherein: The electrodes are arranged in pairs, and include electrodes for receiving electrical signals from a living body and electrodes for electrical treatment that pass current through the living body.

9. The living body electrode device according to claim 1, wherein: The wiring member has a meandering pattern.

10. The living body electrode device according to claim 2, wherein: The wiring member has a meandering pattern, The sheet member has slits at arbitrary locations in the zigzag pattern.

11. The living body electrode device according to claim 2, wherein: The electrode is fixed to a portion of the wall surface of a hole opened in the sheet member and covered with the wiring member with a fitting tolerance of "transition fit" or "interference fit".

12. The living body electrode device according to claim 2, wherein: The connecting member is fixed to a portion of the wall surface of a hole opened in the sheet member and covered with the wiring member, with a matching tolerance of "transition fit" or "interference fit".

13. The living body electrode device according to claim 1, wherein: The electrode is fixed in a state in which the electrode is held between the wiring member and the adhesive sheet and in a state in which a protruding portion of the electrode is exposed from a hole opened in the wiring member.

14. The living body electrode device according to claim 1, wherein: The connection member is inserted into and fixed in a hole opened in the wiring member.

15. The living body electrode device according to claim 1, wherein: The adhesive sheet is porous.

16. The living body electrode device according to claim 1, wherein: The pressure-sensitive adhesive sheet is printed with conductive ink.

17. The living body electrode device according to claim 1, wherein: The adhesive sheet is attached with a metal foil.

18. A living body electrode device, comprising: Electrode pads, and A photocurable resin that can be attached to a living body in the form of covering the electrode sheet, The electrode sheet has: at least one pair of electrodes for receiving electrical signals from a biological body, A wiring member for transmitting the received biological electrical signal, A sensor module that outputs signals related to biological electrical signals to the outside, and A connecting member connects the transmitted biological electrical signal to the sensor module.

19. The living body electrode device according to claim 18, wherein: The photocurable resin is coated on a PET film.

20. The living body electrode device according to claim 18, wherein The photocurable resin can respectively attach the electrode and the sensor module to a biological body.

21. The living body electrode device according to claim 18, wherein: Part or all of the electrodes are used as electrodes for electrical therapy.

22. The living body electrode device according to claim 1 or claim 18, wherein: The sensor module is arranged on the surface of the electrode sheet on the living body side.

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