WO2022009792A1 - Dispositif biologique à faible adhésivité - Google Patents

Dispositif biologique à faible adhésivité Download PDF

Info

Publication number
WO2022009792A1
WO2022009792A1 PCT/JP2021/025114 JP2021025114W WO2022009792A1 WO 2022009792 A1 WO2022009792 A1 WO 2022009792A1 JP 2021025114 W JP2021025114 W JP 2021025114W WO 2022009792 A1 WO2022009792 A1 WO 2022009792A1
Authority
WO
WIPO (PCT)
Prior art keywords
thin film
polymer thin
adhesive
biological device
biological
Prior art date
Application number
PCT/JP2021/025114
Other languages
English (en)
Japanese (ja)
Inventor
俊宣 藤枝
まりも 伊藤
美都子 ▲濱▼
晃広 齋藤
Original Assignee
国立大学法人東京工業大学
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Application filed by 国立大学法人東京工業大学 filed Critical 国立大学法人東京工業大学
Priority to JP2022535292A priority Critical patent/JPWO2022009792A1/ja
Publication of WO2022009792A1 publication Critical patent/WO2022009792A1/fr

Links

Images

Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00—Measuring for diagnostic purposes; Identification of persons
    • A61B5/24—Detecting, measuring or recording bioelectric or biomagnetic signals of the body or parts thereof
    • A61B5/25—Bioelectric electrodes therefor
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00—Measuring for diagnostic purposes; Identification of persons
    • A61B5/24—Detecting, measuring or recording bioelectric or biomagnetic signals of the body or parts thereof
    • A61B5/25—Bioelectric electrodes therefor
    • A61B5/263—Bioelectric electrodes therefor characterised by the electrode materials
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00—Measuring for diagnostic purposes; Identification of persons
    • A61B5/24—Detecting, measuring or recording bioelectric or biomagnetic signals of the body or parts thereof
    • A61B5/25—Bioelectric electrodes therefor
    • A61B5/263—Bioelectric electrodes therefor characterised by the electrode materials
    • A61B5/266—Bioelectric electrodes therefor characterised by the electrode materials containing electrolytes, conductive gels or pastes
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61N—ELECTROTHERAPY; MAGNETOTHERAPY; RADIATION THERAPY; ULTRASOUND THERAPY
    • A61N1/00—Electrotherapy; Circuits therefor
    • A61N1/02—Details
    • A61N1/04—Electrodes

Definitions

  • the present invention relates to a low-adhesive biological device, a polymer thin film for reducing the adhesiveness of the adhesive gel of the biological device, and a method of reducing the adhesiveness of the adhesive gel of the biological device.
  • Bioelectrodes are used to measure these biological signals.
  • a bioelectrode is used by attaching it to the affected area.
  • the bioelectrode, glucose sensor, pH sensor, ion sensor, gas sensor, thermometer, acceleration sensor and strain sensor also have an electrode portion as a constituent member thereof, and the electrode portion is adhered to the skin or the like with an adhesive gel. It is used (Non-Patent Document 1).
  • Non-Patent Document 2 Non-Patent Document 3
  • An object of the present invention is to provide a low-adhesive biological device that can not only reduce adhesiveness but also maintain the ability to send and receive electrical signals as electrodes.
  • the present inventors have developed a low-adhesion biological device. Specifically, a polymer thin film having a thickness of several tens to 2000 nm made of a polymer material is attached onto the adhesive gel of a biological device such as a bioelectrode, while reducing the adhesiveness of the adhesive gel.
  • a biological device such as a bioelectrode
  • the present invention is a low-adhesive biological device having reduced adhesiveness to a biological part to be adhered, wherein the biological device is adhered to an electrode portion and an electrode surface of the electrode portion.
  • a living body having a gel layer and a polymer thin film laminated on the surface of the adhesive gel layer, and maintaining the ability to send and receive electrical signals to and from the living body, while having a reduced adhesive strength than that of the adhesive gel layer.
  • a biological device having adhesiveness to.
  • the polymer thin film may be formed of a plurality of layers.
  • the film thickness of the polymer thin film may be 50 to 2000 nm.
  • the ratio of the adhesive force of the biological device to the living body to the adhesive force of the adhesive gel layer to the living body may be 10 to 90%.
  • the biological device may be selected from a biological electrode, a glucose sensor, a pH sensor, an ion sensor, a gas sensor, a thermometer, an acceleration sensor or a strain sensor.
  • the biological device of the present invention may be a biological device for preventing or alleviating skin disorders caused by the adhesive gel layer.
  • the present invention is a polymer thin film laminated on the surface of the adhesive gel layer of the biological device, which is a polymer for reducing the adhesiveness of the adhesive gel of the biological device while retaining the transmission and reception of electric signals. Provides a thin film.
  • the polymer thin film of the present invention may be formed of a plurality of layers.
  • the film thickness of the polymer thin film may be 50 to 2000 nm.
  • the ratio of the adhesive force of the biological device to the adhesive force of the adhesive gel layer may be 10 to 90%.
  • the biological device may be selected from a biological electrode, a glucose sensor, a pH sensor, an ion sensor, a gas sensor, a thermometer, an acceleration sensor or a strain sensor.
  • the polymer thin film of the present invention may be a polymer thin film for preventing or alleviating skin disorders caused by the adhesive gel layer.
  • the present invention provides a method of laminating a polymer thin film in the biological device to reduce the adhesiveness of the adhesive gel of the biological device to the living body while maintaining the exchange of electric signals.
  • the polymer thin film may be formed of a plurality of layers.
  • the film thickness of the polymer thin film may be 50 to 2000 nm.
  • the ratio of the adhesive force of the bioelectrode to the adhesive force of the adhesive gel layer may be 10 to 90%.
  • the biological device may be selected from a biological electrode, a glucose sensor, a pH sensor, an ion sensor, a gas sensor, a thermometer, an acceleration sensor or a strain sensor.
  • the method of the present invention may be a method for preventing or alleviating skin disorders caused by the adhesive gel layer.
  • the figure of the photograph which shows the state which adhered and attached the biological device of this invention to a human upper arm part.
  • the schematic diagram which shows the fabrication of the bioelectrode of low adhesiveness.
  • a schematic diagram showing the state of score evaluation Schematic diagram of adhesiveness evaluation by a tensile tester.
  • the photographic figure which shows the state of the measurement of sEMG.
  • the figure which shows the result of the fluorescence observation of the polymer thin film attached to the bioelectrode.
  • the figure which shows the correlation between the film thickness and the adhesiveness score The figure which shows the correlation between the film thickness of a polymer thin film, and the adhesive force in a biological device using Vitrod (registered trademark) F-150M as a biological electrode.
  • the figure which shows the result of having observed the sEMG signal of Example 1 (the SBS film of 110 nm thickness was attached to the adhesive gel layer).
  • the figure which shows the result of having observed the sEMG signal of Example 5 (the SBS film of 1770 nm thickness was attached to the adhesive gel layer).
  • the figure which shows the result of having observed the sEMG signal of Example 6 (the PDMS film of 160 nm thickness was attached to the adhesive gel layer).
  • the figure which shows the result of having observed the sEMG signal of Example 9 (the PDMS film of 1060 nm thickness was attached to the adhesive gel layer).
  • the figure which shows the result of having observed the sEMG signal of Example 10 (the PS film of 120 nm thickness was attached to the adhesive gel layer).
  • the figure which shows the result of having observed the sEMG signal of Example 13 (the PS film of 500 nm thickness was attached to the adhesive gel layer).
  • the figure which shows the result of observing the sEMG signal of a positive control group (without affixing a polymer thin film).
  • the figure which shows the result of having observed the sEMG signal of Example 17 (the PLA film of 160 nm thickness was attached to the adhesive gel layer).
  • the figure which shows the result of having observed the sEMG signal of Example 18 (the porous thin film of 140 nm thickness was attached to the adhesive gel layer).
  • the figure which shows the result of having observed the sEMG signal of Example 19 (the polymer thin film which laminated the PEDOT / PSS film and the SBS film was attached to the adhesive gel layer).
  • the figure which shows the result of having observed the sEMG signal of Example 20 (a polymer thin film which laminated SBS film and PEDOT / PSS film was attached to the adhesive gel layer).
  • One of the embodiments of the present invention is a biological device. More specifically, it is a low-adhesive biological device having reduced adhesiveness to a biological part to be adhered, wherein the biological device includes an electrode portion, an adhesive gel layer adhered to an electrode surface of the electrode portion, and the like. It has a polymer thin film laminated on the surface of the adhesive gel layer, and while maintaining the ability to exchange electrical signals with the living body, the adhesiveness to the living body is reduced by the adhesive strength of the adhesive gel layer. It is a biological device having.
  • the electrode portion refers to an electrode portion for transmitting and receiving an electric signal in the biological device of the present invention.
  • the electrode is not limited to the electrode portion that receives an electrical signal from the living body or gives an electrical stimulus to the living body, and the electrode is a biological component intended for measurement.
  • the electrode is used as an electrode unit in combination with various sensor units, and includes an electrode for measuring a change in an electric signal caused by sensing a biological component to be measured.
  • Examples of the biological device of the present invention include a biological electrode, a glucose sensor, a pH sensor, an ion sensor, a gas sensor, a thermometer, an acceleration sensor, a strain sensor and the like. These biological devices can be used for various devices such as electroencephalographs, electromyograms, electrocardiographs, and electrical stimulators.
  • Conventional products of these biological devices have an adhesive gel layer on the electrode portion and the electrode surface of the electrode portion, and are used by adhering to an organ such as skin, and direct or indirect electricity with the living body. Signals are sent and received.
  • the conventional product of this biological device has a strong adhesive force to the skin or the like of the adhesive gel, and may cause skin disorders including inflammation such as redness or rash, which has been a problem.
  • a polymer thin film is attached to the surface of the adhesive gel layer using a commercially available biological electrode or various sensors, and the adhesive gel layer and the polymer thin film are laminated. Therefore, it can be manufactured as a biological device having reduced adhesiveness to skin and the like.
  • the biological device of the present invention retains the transfer of electrical signals to and from the living body and the measurement of electrical signals changed by various sensors, while providing the adhesive force to the living body, which is less than the adhesive strength of the adhesive gel layer.
  • the polymer thin film used in the biological device of the present invention does not necessarily have adhesive strength by itself. However, even when the polymer thin film itself does not have adhesive strength, the adhesiveness is reduced by laminating the polymer thin film on the surface of the adhesive gel layer, but the surface of the polymer film is applied to organs such as skin.
  • the present inventors have discovered that they have adhesiveness and can exchange electrical signals with living organisms. The present invention is based on this finding.
  • the biological device of the present invention can be used without causing deviation with respect to the target site by adhering the polymer thin film surface to the skin or the like of the living body. At this time, the ability to send and receive electric signals can be maintained through the polymer thin film.
  • the material of the polymer thin film used in the biological device of the present invention is not particularly limited as long as it is a polymer thin film, and includes non-conductive polymers and conductive polymers. Further, it may be an elastomer or a hard polymer thin film. Further, a plurality of polymers may be contained in the polymer thin film. Typical examples of the material of this polymer thin film are polystyrene-block-polybutadiene-block-polystyrene (SBS), polydimethylsiloxane (PDMS), polystyrene (PS), poly-L-lactic acid (PLLA), and poly-D-.
  • SBS polystyrene-block-polybutadiene-block-polystyrene
  • PDMS polydimethylsiloxane
  • PS polystyrene
  • PLLA poly-L-lactic acid
  • poly-D- poly-D-.
  • Lactic acid (PDLA), poly-D, L-lactic acid (PDLLA), polycaprolactone (PCL), polyglycolic acid (PLGA), polylactic acid-glycolic acid copolymer (PLGA), chitosan, alginic acid, poly (4-styrene).
  • Polystyrene (3,4-ethylenedioxythiophene) (PEDOT: PSS) doped with (styrene acid) can be mentioned.
  • the polymer thin film may be a polymer thin film made of a material obtained by combining and mixing materials of the various materials.
  • a polymer thin film prepared by using a material obtained by combining polylactic acid and polystyrene and mixing them the polymer thin film becomes porous, so that when it is used as a biological device, it does not depend on an adhesive gel. Since the adhesiveness to the skin is improved, good electrode characteristics can be maintained (see Example 18).
  • the composition of the polymer thin film used in the biological device of the present invention may be a plurality of layers as long as it acts as a biological device.
  • the materials described in the material of the polymer thin film can be used in combination.
  • the conductivity is improved as compared with the case where the polymer thin film is formed by SBS alone. It is possible to maintain good electrode characteristics (see Examples 19 and 20).
  • the polymer thin film used in the biological device of the present invention can contain additives as long as it acts as a biological device.
  • the amount of the additive is preferably in the range of 0 to 5% by mass with respect to the total mass of the polymer thin film phase.
  • Known additives include, for example, antioxidants, weathering stabilizers, heat stabilizers, lubricants, crystal nucleating agents, UV absorbers, colorants, surfactants and the like.
  • a plurality of types of additives may be contained.
  • particles made of an inorganic or organic compound may be contained. The amount of particles is preferably in the range of 0 to 5% by mass with respect to the total mass of the adhesion prevention layer.
  • Examples of known particles include particles made of calcium carbonate, titanium dioxide, silicon dioxide, calcium fluoride, lithium fluoride, alumina, barium sulfate, zirconia, calcium phosphate and the like, crosslinked polystyrene particles, metal nanoparticles and the like. Be done.
  • the film formation of the polymer thin film used for manufacturing the biological device of the present invention can be performed by using a known film formation method such as a roll-to-roll method using a gravure coater.
  • a gravure coater is used to coat, for example, a polyethylene terephthalate (PET) film with an aqueous solution of a sacrificial first layer of polyvinyl alcohol (PVA) and then dried to form a PVA layer.
  • PVA polyvinyl alcohol
  • the PVA layer is coated with a solution of the polymer thin film material constituting the biological device of the present invention, for example, a tetrahydrofuran solution of SBS, dried, and the second layer is laminated.
  • a laminated film in which the first layer and the second layer are laminated is produced.
  • a paper tape is attached to the surface on which the second layer is formed so as to border the required shape, and the two-layer film including the first layer and the second layer is peeled off from the edge. It is peeled off from the PET film while being held in place.
  • the paper tape holding the SBS polymer thin film is cut out into a desired shape and used, and the polymer thin film of the second layer is laminated on the adhesive gel layer of the biological device to form the second layer on the adhesive gel layer. It is possible to manufacture a biological device in which a polymer thin film is laminated.
  • the size of the polymer thin film used in the biodevice of the present invention may be such that the adhesive gel layer contained in the bioelectrode or various sensors is sufficiently covered, and the polymer thin film may be larger than the adhesive gel layer. No (Fig. 1).
  • the biological device of the present invention only needs to have the adhesive gel layer in sufficient contact with the polymer thin film, and can be configured differently depending on the application. That is, the adhesive gel layer contained in the bioelectrode or various sensors may be coated with a polymer thin film in advance to prepare a low-adhesive biological device, and then adhered to a target site such as skin in advance.
  • a structure of a low-adhesive biodevice may be provided by adhering a bioelectrode or various sensors on the polymer thin film after the polymer thin film is attached to the polymer thin film.
  • An example of the film thickness of the polymer thin film in the biological device of the present invention is 50 to 2000 nm, preferably 50 to 1000 nm, and more preferably 100 to 500 nm.
  • the ratio of the adhesive force of the biological device to the living body to the adhesive force of the adhesive gel layer to the living body is 10 to 90%, preferably 20 to 80%, and more preferably 30 to 70%.
  • the biological device of the present invention can reduce the adhesive force of the adhesive gel and prevent or reduce the skin damage caused by the adhesive gel layer by laminating a polymer thin film on the surface of the adhesive gel layer.
  • polymer thin film Another embodiment of the present invention is a polymer thin film. More specifically, it is a polymer thin film laminated on the surface of the adhesive gel layer of the biological device described in the above "1. Biodevice", and is an adhesive gel of the biological device while retaining the exchange of electrical signals. It is a polymer thin film for reducing the adhesiveness of the material.
  • the polymer thin film of the present invention is a polymer thin film constituting the biological device described in the above "1. Biological device”.
  • the polymer thin film of the present invention can be manufactured and used by the manufacturing method described in the above section "1. Biological device”.
  • An example of the film thickness of the polymer thin film in the polymer thin film of the present invention is 50 to 2000 nm, preferably 50 to 1000 nm, and more preferably 100 to 500 nm.
  • the ratio of the adhesive force of the biological device to the living body to the adhesive force of the adhesive gel layer to the living body is preferably 10 to 90%. It is 20 to 80%, more preferably 30 to 70%.
  • the polymer thin film of the present invention is a polymer for reducing the adhesion of various devices such as bioelectrodes, glucose sensors, pH sensors, ion sensors, gas sensors, thermometers, acceleration sensors, and strain sensors to organs such as skin. Can be used as a thin film.
  • the polymer thin film of the present invention it is possible to reduce the adhesive force of the adhesive gel in the biological device and prevent or reduce the skin damage caused by the adhesive gel layer.
  • Another embodiment of the present invention is the method for reducing the adhesiveness of biological devices described in the above "1. Biological device”. More specifically, in the above-mentioned biological device, it is a method of reducing the adhesiveness of the adhesive gel of the biological device to the living body while maintaining the exchange of electric signals by laminating the polymer thin film.
  • examples of the film thickness of the polymer thin film include 50 to 2000 nm, preferably 50 to 1000 nm, and more preferably 100 to 500 nm.
  • the ratio of the adhesive force of the biological device to the living body to the adhesive force of the adhesive gel layer to the living body is 10 to 90%, preferably 20. It is -80%, more preferably 30-70%.
  • bioelectrodes glucose sensors
  • pH sensors pH sensors
  • ion sensors gas sensors
  • thermometers thermometers
  • accelerometers and strain sensors that reduce the adhesive force of the adhesive gel in the biodevices.
  • the method of the present invention it is possible to reduce the adhesive force of the adhesive gel in the biological device and prevent or reduce the skin damage caused by the adhesive gel layer.
  • the polymer thin film was formed based on the gravure printing method (hereinafter referred to as the gravure method). More specifically, on a PET film, a polystyrene-block-polybutadiene-block-polystyrene (SBS) polymer thin film (Examples 1 to 5 and Examples 14) and a polydimethylsiloxane (PDMS) polymer thin film (PDMS) Examples 6-9 and 15), polystyrene (PS) polymer thin films (Examples 10-13 and 16), polylactic acid (PLA) polymer thin films (Example 17), porous (Porous).
  • SBS polystyrene-block-polybutadiene-block-polystyrene
  • PDMS polydimethylsiloxane
  • PS polystyrene
  • PS polymer thin films
  • PLA polylactic acid
  • porous Porous
  • Table 1 below describes the details of the preparation conditions for the first layer, Table 2 for the second layer, and Table 3 for the third layer.
  • a release layer of the first layer was formed.
  • polyvinyl alcohol Poly vinyl alcohol: PVA, manufactured by Kanto Chemical Co., Inc., Mw 22,000, hydrolysis rate 86.5 to 89%) was used. PVA was adjusted to 5.0% (w / w) using pure water as a solvent, and a film was formed at a gravure rotation speed of 30 rpm, a line speed of 1.0 m / min, and a drying temperature of 80 ° C.
  • Table 1 shows the preparation conditions for the first layer.
  • a second polymer thin film layer was formed.
  • Polystyrene-block-polybutadiene-block-polystyrene (Polystyrene-block-polybutadie-block-polystyrene style: SBS, manufactured by Sigma-Aldrich, Mw 140,000, 30% styrene block) was used as the raw material for the second layer. .. Tetrahydrofuran (THF, manufactured by Wako Pure Chemical Industries, Ltd., special grade reagent) was used as a solvent, and the concentration was adjusted to various concentrations (2,3,10,20% (w / w)).
  • Each of the prepared solutions was formed on the first PVA layer at a gravure rotation speed of 10 to 50 rpm, a line speed of 0.4 to 1.3 m / min, and a drying temperature of 40 ° C., and made of SBS having different film thicknesses.
  • a polymer thin film was prepared. Table 2 shows the preparation conditions for the second layer.
  • a paper tape (3M Co., Ltd., masking tape 243J Plus 243J15) is attached to the surface on which the polymer thin film is formed so as to border the required shape, and peeled off from the edges to form the first layer and the second layer.
  • the two-layer film containing the above was peeled off from the PET film while being held on the paper tape.
  • a second polymer thin film layer was formed.
  • polydimethylsiloxane Polydimethicyl siloxane: PDMS, SYLGARD (registered trademark) 184 Silicone Elastomer, manufactured by Dow Corning Co., Ltd.
  • Hexane manufactured by Fujifilm Wako Pure Chemical Industries, Ltd., special grade reagent
  • ethyl acetate manufactured by Fujifilm Wako Pure Chemical Industries, Ltd., special grade reagent
  • the PDMS solution was adjusted to various concentrations using a mixed solvent (10,15% (w / w)).
  • a mixed solvent (10,15% (w / w)
  • Each of the prepared solutions was formed on the first PVA layer at a gravure rotation speed of 20 to 50 rpm, a line speed of 0.2 m / min, and a drying temperature of 80 ° C.
  • the formed film was fired in a drying oven at 80 ° C. for 12 hours to prepare PDMS polymer thin films having different film thicknesses.
  • Table 2 shows the preparation conditions for the second layer.
  • a second polymer thin film layer was formed.
  • polystyrene Polystyrene: PS, manufactured by Sigma-Aldrich, Mw 280,000
  • Ethyl acetate manufactured by Wako Pure Chemical Industries, Ltd., special grade reagent
  • concentration was adjusted to various levels (2.5% (w / w)).
  • Each of the prepared solutions was formed on the first PVA layer at a gravure rotation speed of 20 to 40 rpm, a line speed of 1.0 to 1.3 m / min, and a drying temperature of 60 ° C., and made of PS having different film thicknesses.
  • a polymer thin film was prepared. Table 2 shows the preparation conditions for the second layer.
  • a second polymer thin film layer was formed.
  • polylactic acid Polylactic acid: PLA, manufactured by Polysciences Inc., Mw 300,000-600,000
  • concentration was adjusted to 2.0% (w / w) using ethyl acetate (manufactured by Wako Pure Chemical Industries, Ltd., special grade reagent) as a solvent.
  • the prepared solution was formed on the first PVA layer at a gravure rotation speed of 30 rpm, a line speed of 1.3 m / min, and a drying temperature of 60 ° C. Table 2 shows the preparation conditions for the second layer.
  • a second polymer thin film layer was formed.
  • polylactic acid Polylactic acid: PLA, Polysciences Inc., Mw 300,000-600,000
  • polystyrene Polystylerene: PS, Sigma-Aldrich, Mw 280,000
  • PLA ethyl acetate
  • PS ethyl acetate
  • a porous polymer thin film made of PLA was prepared by immersing a blend membrane having a phase-separated structure of PLA and PS in cyclohexane (manufactured by Kanto Chemical Co., Inc.) and selectively dissolving the PS phase.
  • Table 2 shows the preparation conditions for the second layer.
  • PEDOT PSS dispersion (manufactured by Heraeus, Clevios PH100) as the raw material for the third layer, and butanediol (1,4-Butanediol: BG, manufactured by Fujifilm Wako Pure Chemical Industries, Ltd.) as an additive, 5% ( w / w) and FS-31 (Capstone FS-31 manufactured by Sigma-Aldrich) were used.
  • BG was added to the PEDOT: PSS dispersion at a concentration of 5% (w / w) and FS-31 was added at a concentration of 1% (v / v).
  • the prepared solution was formed on the PVA of the first layer and the SBS of the second layer at a gravure rotation speed of 15 rpm, a line speed of 0.2 m / min, and a drying temperature of 80 ° C. to prepare a PEDOT: PSS polymer thin film. did.
  • Table 3 shows the preparation conditions for the third layer.
  • a natural convection low-temperature dryer (SONW-300S-R, manufactured by AS ONE) was used to heat-treat at 140 degrees for 15 minutes to prepare a PEDOT: PSS polymer thin film.
  • Example 19 the third PEDOT: PSS layer was attached so as to cover the adhesive gel layer of the bioelectrode to prepare a biodevice.
  • Example 20 the second SBS layer was attached so as to cover the adhesive gel layer of the bioelectrode to prepare a biodevice.
  • a score of 0 indicates that there is no adhesiveness, the adhesive layer does not follow, and the adhesiveness is insufficient as a bioelectrode.
  • the adhesive feeling is strong, the adhesive layer strongly follows, and it indicates that the bioelectrode has sufficient adhesiveness.
  • a positive control group an existing bioelectrode itself to which a polymer thin film was not attached was used, and a qualitative evaluation based on an adhesive score was performed.
  • the button portion of the bioelectrode was gripped with a clip on a tensile tester (EZ-SX 5N, manufactured by Shimadzu Corporation) and connected to the load cell.
  • An artificial skin (Bioskin plate manufactured by Bulux Co., Ltd.) was placed under the bioelectrode and lowered at 0.5 mm / min to bring it into contact with the artificial skin. It was lowered until a stress of 1 N was applied at a contact area of 1 cm 2, and then increased at 0.5 mm / min until the stress became zero.
  • sEMG using a low-adhesive bioelectrode was measured (Fig. 4). Specifically, the measurement was performed under the conditions of a sampling rate of 1,000 Hz and a power line filter of 50 Hz. In addition, two electrodes were mounted at a position 10 cm distal to the elbow on the dominant arm side so that the distance between the electrodes was 2 cm. In addition, it touched the ground at the position of the wrist. The operation of grasping the baseball ball for 3 seconds and then performing for 3 seconds was performed for 5 cycles, and the sEMG signal was measured. As the positive control group, the existing bioelectrode itself to which the polymer thin film was not attached was used.
  • SNR signal-to-noise ratio
  • SNR was calculated from the signal diagram obtained in 1) according to the following (Equation 1).
  • SNR (db) 20log 10 ( A s / A n) ( Equation 1)
  • a s is the maximum value of the signal obtained in time in which focus
  • a n denotes the standard deviation of the background signal obtained in the time that does not focus.
  • the electrode performance of the low-adhesion bioelectrode was evaluated by using the SNR value and comparing it with the value of the positive control group.
  • the film thickness of the polymer thin film decreased, the SNR value increased and it was possible to acquire the myoelectric signal more easily.
  • the film thickness of less than 200 nm was only about 10% different from that of the positive control group, and the characteristics as an electrode could be maintained (FIGS. 10 to 20).
  • the low-adhesive bioelectrode using the two-layer film of PEDOT: PSS and SBS as the polymer thin film was compared with the low-adhesion bioelectrode using the polymer thin film of another material. It was shown that the characteristics as an electrode were better maintained (FIGS. 19 and 20).
  • the existing bioelectrode (Nihon Kohden, Vitrode (registered trademark) F150M) itself, which does not have a polymer thin film attached, is attached to the inside of the upper arm and then removed. The degree of inflammatory symptoms at the site of application was observed.
  • -Positive control group Commercially available bioelectrode (Nihon Kohden, Vitrode (registered trademark) F150M)
  • SBS A low-adhesive biological device using the polymer thin film of Example 1 c.
  • PDMS Low-adhesive biological device using the polymer thin film of Example 6-PS: Low-adhesive biological device using the polymer thin film of Example 10-PEDOT: PSS / SBS: Polymer thin film of Example 19. Low-adhesive biological device using the
  • FIGS. 21A and 21A show photographs showing the state before, during, and immediately after attachment of a commercially available bioelectrode, which is a group of low-adhesive biological devices or a positive control group, after being attached and removed for 2 hours, respectively.
  • 21B shown in FIG. 21C.
  • the low-adhesive device of the present invention suppresses the induction of adverse events such as skin inflammation and is useful.
  • the biological device of the present invention is used for diagnosis and / or treatment of diseases by adhering to organs such as skin as a biological electrode, glucose sensor, pH sensor, ion sensor, gas sensor, thermometer, acceleration sensor, strain sensor and the like.
  • organs such as skin as a biological electrode, glucose sensor, pH sensor, ion sensor, gas sensor, thermometer, acceleration sensor, strain sensor and the like.
  • These biological devices can be used for various devices such as electroencephalographs, electromyograms, electrocardiographs, and electrical stimulators.
  • Bioelectrode 2 Polymer thin film attached to the skin 11: Polymer thin film 12: Adhesive layer 13: Base material 14: Electrode 20: Low adhesive bioelectrode 30: Skin

Landscapes

  • Health & Medical Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • Veterinary Medicine (AREA)
  • Public Health (AREA)
  • Engineering & Computer Science (AREA)
  • Biomedical Technology (AREA)
  • General Health & Medical Sciences (AREA)
  • Pathology (AREA)
  • Molecular Biology (AREA)
  • Surgery (AREA)
  • Medical Informatics (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Physics & Mathematics (AREA)
  • Biophysics (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Radiology & Medical Imaging (AREA)
  • Medicinal Preparation (AREA)

Abstract

Un problème de dispositifs biologiques classiques, tels que des électrodes biologiques, est que les couches de gel adhésif de ceux-ci ont une adhésivité excessivement élevée. La présente invention concerne un dispositif biologique à faible adhésivité ayant une adhésivité réduite à une partie cible d'adhérence d'un corps vivant. Le dispositif biologique comprend : une unité d'électrode ; une couche de gel adhésif liée à une surface d'électrode de l'unité d'électrode ; et un film mince de polymère stratifié sur la surface de la couche de gel adhésif. Le dispositif biologique présente une adhésivité réduite à un corps vivant par comparaison à la force adhésive de la couche de gel adhésif tout en maintenant la capacité à transmettre et à recevoir des signaux électriques vers et depuis le corps vivant. L'invention concerne également : un film mince polymère pour réduire l'adhésivité d'un gel adhésif d'un dispositif biologique ; et un procédé pour réduire l'adhésivité d'un gel adhésif d'un dispositif biologique à un corps vivant tout en maintenant la capacité à émettre et à recevoir des signaux électriques.
PCT/JP2021/025114 2020-07-08 2021-07-02 Dispositif biologique à faible adhésivité WO2022009792A1 (fr)

Priority Applications (1)

Application Number Priority Date Filing Date Title
JP2022535292A JPWO2022009792A1 (fr) 2020-07-08 2021-07-02

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
JP2020117766 2020-07-08
JP2020-117766 2020-07-08

Publications (1)

Publication Number Publication Date
WO2022009792A1 true WO2022009792A1 (fr) 2022-01-13

Family

ID=79552599

Family Applications (1)

Application Number Title Priority Date Filing Date
PCT/JP2021/025114 WO2022009792A1 (fr) 2020-07-08 2021-07-02 Dispositif biologique à faible adhésivité

Country Status (2)

Country Link
JP (1) JPWO2022009792A1 (fr)
WO (1) WO2022009792A1 (fr)

Cited By (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN115282496A (zh) * 2022-06-30 2022-11-04 深圳市恒天伟焱科技股份有限公司 光电针灸治疗装置

Citations (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
JP2001057967A (ja) * 2000-01-01 2001-03-06 Advance Co Ltd 生体用電極の製造方法
JP2015531005A (ja) * 2012-07-12 2015-10-29 プレジデント アンド フェローズ オブ ハーバード カレッジ 易滑性自己潤滑性ポリマー表面
JP2020019842A (ja) * 2018-07-30 2020-02-06 積水化成品工業株式会社 ハイドロゲル

Patent Citations (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
JP2001057967A (ja) * 2000-01-01 2001-03-06 Advance Co Ltd 生体用電極の製造方法
JP2015531005A (ja) * 2012-07-12 2015-10-29 プレジデント アンド フェローズ オブ ハーバード カレッジ 易滑性自己潤滑性ポリマー表面
JP2020019842A (ja) * 2018-07-30 2020-02-06 積水化成品工業株式会社 ハイドロゲル

Cited By (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN115282496A (zh) * 2022-06-30 2022-11-04 深圳市恒天伟焱科技股份有限公司 光电针灸治疗装置

Also Published As

Publication number Publication date
JPWO2022009792A1 (fr) 2022-01-13

Similar Documents

Publication Publication Date Title
Zhang et al. Skin‐friendly electronics for acquiring human physiological signatures
Zhang et al. Fully organic compliant dry electrodes self-adhesive to skin for long-term motion-robust epidermal biopotential monitoring
Hwang et al. Multifunctional smart skin adhesive patches for advanced health care
Zhang et al. On-skin ultrathin and stretchable multifunctional sensor for smart healthcare wearables
Sun et al. Water-resistant and underwater adhesive ion-conducting gel for motion-robust bioelectric monitoring
Manjakkal et al. Flexible potentiometric pH sensors for wearable systems
Jin et al. Advanced materials for health monitoring with skin‐based wearable devices
Baek et al. Flexible polymeric dry electrodes for the long-term monitoring of ECG
Choi et al. Cephalopod-inspired miniaturized suction cups for smart medical skin
Cai et al. Locally coupled electromechanical interfaces based on cytoadhesion-inspired hybrids to identify muscular excitation-contraction signatures
Yeo et al. Multifunctional epidermal electronics printed directly onto the skin
Lee et al. A strain-absorbing design for tissue–machine interfaces using a tunable adhesive gel
Wang et al. A cyclic freezing-thawing approach to layered Janus hydrogel tapes with single-sided adhesiveness for wearable strain sensors
Meng et al. Self-adhesive, biodegradable silk-based dry electrodes for epidermal electrophysiological monitoring
WO2022009792A1 (fr) Dispositif biologique à faible adhésivité
Liu et al. Breathable, self-adhesive dry electrodes for stable electrophysiological signal monitoring during exercise
WO2015141988A1 (fr) Dispositif électronique multifonctionnel vestimentaire, et son procédé de fabrication
CN114981354A (zh) 聚合物复合物及其制备方法和用途
JP5799184B1 (ja) 透明導電積層体およびその製造方法
Hua et al. Hydrogel-based bioelectronics and their applications in health monitoring
Lee et al. Ultra-intimate hydrogel hybrid skin patch with asymmetric elastomeric spatula-like cylinders
Zhang et al. Stretchable and durable HD-sEMG electrodes for accurate recognition of swallowing activities on complex epidermal surfaces
Kateb et al. Printable, adhesive, and self-healing dry epidermal electrodes based on PEDOT: PSS and polyurethane diol
Wan et al. A reusable, healable, and biocompatible PEDOT: PSS hydrogel-based electrical bioadhesive interface for high-resolution electromyography monitoring and time–frequency analysis
Xu et al. Facile fabrication of multilayer stretchable electronics via a Two-mode mechanical cutting process

Legal Events

Date Code Title Description
121 Ep: the epo has been informed by wipo that ep was designated in this application

Ref document number: 21835928

Country of ref document: EP

Kind code of ref document: A1

ENP Entry into the national phase

Ref document number: 2022535292

Country of ref document: JP

Kind code of ref document: A

NENP Non-entry into the national phase

Ref country code: DE

122 Ep: pct application non-entry in european phase

Ref document number: 21835928

Country of ref document: EP

Kind code of ref document: A1