WO2023157718A1 - 医療機器 - Google Patents

医療機器 Download PDF

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Publication number
WO2023157718A1
WO2023157718A1 PCT/JP2023/003981 JP2023003981W WO2023157718A1 WO 2023157718 A1 WO2023157718 A1 WO 2023157718A1 JP 2023003981 W JP2023003981 W JP 2023003981W WO 2023157718 A1 WO2023157718 A1 WO 2023157718A1
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WO
WIPO (PCT)
Prior art keywords
inlet
gasket
inlet connector
medical device
opening
Prior art date
Legal status (The legal status 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 status listed.)
Ceased
Application number
PCT/JP2023/003981
Other languages
English (en)
French (fr)
Japanese (ja)
Inventor
仁 小笠原
元章 村上
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
Nipro Corp
Original Assignee
Nipro Corp
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 Nipro Corp filed Critical Nipro Corp
Priority to EP23756245.9A priority Critical patent/EP4480534A4/en
Priority to US18/839,179 priority patent/US20250152958A1/en
Priority to JP2024501311A priority patent/JPWO2023157718A1/ja
Publication of WO2023157718A1 publication Critical patent/WO2023157718A1/ja
Anticipated expiration legal-status Critical
Ceased legal-status Critical Current

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Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61N—ELECTROTHERAPY; MAGNETOTHERAPY; RADIATION THERAPY; ULTRASOUND THERAPY
    • A61N2/00—Magnetotherapy
    • A61N2/02—Magnetotherapy using magnetic fields produced by coils, including single turn loops or electromagnets
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61N—ELECTROTHERAPY; MAGNETOTHERAPY; RADIATION THERAPY; ULTRASOUND THERAPY
    • A61N2/00—Magnetotherapy
    • A61N2/004—Magnetotherapy specially adapted for a specific therapy
    • A61N2/008—Magnetotherapy specially adapted for a specific therapy for pain treatment or analgesia
    • F—MECHANICAL ENGINEERING; LIGHTING; HEATING; WEAPONS; BLASTING
    • F16—ENGINEERING ELEMENTS AND UNITS; GENERAL MEASURES FOR PRODUCING AND MAINTAINING EFFECTIVE FUNCTIONING OF MACHINES OR INSTALLATIONS; THERMAL INSULATION IN GENERAL
    • F16J—PISTONS; CYLINDERS; SEALINGS
    • F16J15/00—Sealings
    • F16J15/02—Sealings between relatively-stationary surfaces
    • F16J15/06—Sealings between relatively-stationary surfaces with solid packing compressed between sealing surfaces
    • F16J15/061—Sealings between relatively-stationary surfaces with solid packing compressed between sealing surfaces with positioning means
    • F—MECHANICAL ENGINEERING; LIGHTING; HEATING; WEAPONS; BLASTING
    • F16—ENGINEERING ELEMENTS AND UNITS; GENERAL MEASURES FOR PRODUCING AND MAINTAINING EFFECTIVE FUNCTIONING OF MACHINES OR INSTALLATIONS; THERMAL INSULATION IN GENERAL
    • F16J—PISTONS; CYLINDERS; SEALINGS
    • F16J15/00—Sealings
    • F16J15/02—Sealings between relatively-stationary surfaces
    • F16J15/06—Sealings between relatively-stationary surfaces with solid packing compressed between sealing surfaces
    • F16J15/062—Sealings between relatively-stationary surfaces with solid packing compressed between sealing surfaces characterised by the geometry of the seat
    • F—MECHANICAL ENGINEERING; LIGHTING; HEATING; WEAPONS; BLASTING
    • F16—ENGINEERING ELEMENTS AND UNITS; GENERAL MEASURES FOR PRODUCING AND MAINTAINING EFFECTIVE FUNCTIONING OF MACHINES OR INSTALLATIONS; THERMAL INSULATION IN GENERAL
    • F16J—PISTONS; CYLINDERS; SEALINGS
    • F16J15/00—Sealings
    • F16J15/02—Sealings between relatively-stationary surfaces
    • F16J15/06—Sealings between relatively-stationary surfaces with solid packing compressed between sealing surfaces
    • F16J15/064—Sealings between relatively-stationary surfaces with solid packing compressed between sealing surfaces the packing combining the sealing function with other functions
    • H—ELECTRICITY
    • H01—ELECTRIC ELEMENTS
    • H01R—ELECTRICALLY-CONDUCTIVE CONNECTIONS; STRUCTURAL ASSOCIATIONS OF A PLURALITY OF MUTUALLY-INSULATED ELECTRICAL CONNECTING ELEMENTS; COUPLING DEVICES; CURRENT COLLECTORS
    • H01R13/00—Details of coupling devices of the kinds covered by groups H01R12/70 or H01R24/00 - H01R33/00
    • H01R13/46—Bases; Cases
    • H01R13/52—Dustproof, splashproof, drip-proof, waterproof, or flameproof cases
    • H01R13/5202—Sealing means between parts of housing or between housing part and a wall, e.g. sealing rings
    • H—ELECTRICITY
    • H01—ELECTRIC ELEMENTS
    • H01R—ELECTRICALLY-CONDUCTIVE CONNECTIONS; STRUCTURAL ASSOCIATIONS OF A PLURALITY OF MUTUALLY-INSULATED ELECTRICAL CONNECTING ELEMENTS; COUPLING DEVICES; CURRENT COLLECTORS
    • H01R13/00—Details of coupling devices of the kinds covered by groups H01R12/70 or H01R24/00 - H01R33/00
    • H01R13/46—Bases; Cases
    • H01R13/52—Dustproof, splashproof, drip-proof, waterproof, or flameproof cases
    • H01R13/5224—Dustproof, splashproof, drip-proof, waterproof, or flameproof cases for medical use

Definitions

  • the present invention relates to medical equipment.
  • the present invention is excellent in drip-proof measures, electrostatic discharge/surge (ESD) measures, and electromagnetic interference (EMS) measures characteristic for medical use, and generates a biostimulation signal wave and generates it in a coil.
  • ESD electrostatic discharge/surge
  • EMS electromagnetic interference
  • the present invention relates to a medical device that treats pain in an affected area by irradiating the affected area of a living body with a magnetic field generated by the magnetic field to stimulate cells in the affected area.
  • Patent Document 1 As a device for treating pain in a diseased part by irradiating the diseased part of a living body with a magnetic field to stimulate the cells of the diseased part, for example, the one described in Patent Document 1 is conventionally known.
  • the frequency coil is arranged in a spiral or loop shape and housed in a housing together with the transmission circuit and the battery, thereby making it portable.
  • the high-frequency and low-frequency signals output from the transmission circuit generate magnetic fields with the high-frequency and low-frequency coils, respectively. Irradiation stimulates the cells in the affected area, and the stimulation promotes the production of neurotrophic factors in the cells in the affected area, promoting the repair, growth, differentiation, and proliferation of the cells, thereby treating pain in the affected area.
  • U.S. Patent Application Publication No. 2004/0010001 also includes a system for electromagnetic induction therapy and the like, including one or more ergonomic or body-contoured probes positioned proximate to a coil. one or more conductive coils configured to generate an electromagnetic or magnetic field that is focused onto a target nerve, muscle, or other body tissue, the one or more sensors detecting the stimulus; Utilized to provide feedback regarding the effectiveness of the applied electromagnetic induction therapy, the controller varies the current through the coil to target nerves, muscles, or other components based on feedback provided by sensors or the patient. An adjustable one is disclosed to adjust the magnetic field focused on the body tissue.
  • Patent Document 1 does not have an inlet, but has a high-frequency output coil, a low-frequency output coil, a transmission circuit, and a housing containing a battery, which is drip-proof (IPX). It has not been taken into consideration.
  • IPX drip-proof
  • the sensor described in Patent Document 2 detects the electrical conduction of nerves stimulated by electromagnetic therapy, and the moisture and moisture released from the patient's skin while the electrode carrier is placed on the patient's skin. It enables perspiration to be appropriately discharged to the outside through the ventilation holes.
  • the sensor described in Patent Document 2 does not have an inlet, and its drip-proofness (IPX) and the effects of electrostatic discharge due to contact between the human body and the magnetic therapy device have not been studied at all.
  • drip-proofness is a required performance for medical equipment.
  • medical devices magnetic therapy devices are used in contact with the human body. Therefore, there is a possibility that water and moisture may enter the inside of the magnetic therapy device.
  • a magnetic therapy device that is not drip-proof will cause ground faults and electric leakage accidents because water will enter inside and deteriorate the insulation.
  • a magnetic therapy device having an inlet has an opening for connecting an inlet connector or the like, water and moisture are likely to be absorbed through the opening.
  • a medical device such as a magnetic therapy device equipped with an inlet requires a drip-proof (IPX) property that can prevent moisture from entering the interior and can withstand long-term use of magnetic therapy. .
  • IPX drip-proof
  • ESD Electro-Static Discharge
  • magnetic therapy devices are susceptible to electromagnetic interference. Interference from medical devices such as magnetic therapy devices that are sensitive to electromagnetic interference can adversely affect their performance.
  • ESD electrostatic discharge
  • EMS electromagnetic susceptibility
  • ESD electrostatic discharge/surge
  • EMS electromagnetic interference susceptibility
  • the present invention has been made in view of such technical circumstances, and is excellent in drip-proof (IPX), electrostatic discharge/surge (ESD) countermeasures and electromagnetic interference susceptibility (EMS) countermeasures, and relieves pain in the affected area.
  • An object of the present invention is to provide a medical device capable of obtaining a therapeutic effect necessary for treatment.
  • the medical device of the present invention is a medical device comprising a device body having an inlet for connecting an inlet connector, wherein an inlet opening provided in the inlet and the device body have It is characterized by having a gasket which is interposed between the provided inlet connector connection casing opening and formed so that the inlet can follow the shape of the inlet connector.
  • the gasket includes a first gasket sealing portion closely fitted to the outer peripheral end face of the inlet connector when the inlet connector is pressed against the inlet, and an opening of the gasket.
  • the gasket second sealing portion provided on the inner wall and closely fitted to the inner peripheral side surface of the inlet connector by the inlet connector being pressed against the inlet;
  • waterproof rating (IPX) is 1 or more;
  • the electrostatic discharge resistance is ⁇ 15 kV or more in air electrostatic discharge resistance;
  • a medical device having an inlet with excellent drip-proof (IPX), electrostatic discharge/surge (ESD) countermeasures, and electromagnetic interference susceptibility (EMS) countermeasures. That is, according to the medical device of the present invention, the gasket that allows the inlet to follow the shape of the inlet connector prevents moisture from entering the main body of the medical device and degrading its insulation performance, thereby preventing ground faults and electric leakage accidents. It doesn't even connect.
  • IPX drip-proof
  • ESD electrostatic discharge/surge
  • EMS electromagnetic interference susceptibility
  • the gasket that allows the inlet to follow the shape of the inlet connector ensures the airtightness of the inlet portion, preventing dust from adhering to the drive section inside the main body of the device. not cause any defects.
  • the medical device of the present invention is excellent in drip-proofness (IPX), electrostatic discharge/surge (ESD) countermeasures, and electromagnetic interference susceptibility (EMS) countermeasures.
  • FIG. 1 is a perspective view showing the overall appearance of a magnetic therapy device according to one embodiment of this invention
  • FIG. It is a front view which shows the external appearance of the apparatus main body with which the magnetic therapy apparatus of the said embodiment is provided.
  • Fig. 3 is an enlarged cross-sectional view showing the relationship between the inlet and gasket provided in the magnetic therapy apparatus of the embodiment and the inlet connector connected to the inlet; It is the schematic which shows the structure of the gasket with which the magnetic therapy apparatus of the said embodiment is provided.
  • 4(a) is a front perspective view
  • FIG. 4(b) is a rear perspective view
  • FIG. 4(c) is a cross-sectional view taken along line AA.
  • FIG. 5(a) is a schematic diagram showing a state before the inlet connector is connected to the inlet
  • FIG. 5(b) is a schematic diagram showing a state after the inlet connector is connected to the inlet.
  • FIG. 1 is a perspective view showing the overall appearance of a magnetic therapy device 100, which is an example of medical equipment according to one embodiment of the present invention.
  • medical devices are devices whose manufacture and sale are regulated by the Pharmaceuticals and Medical Devices Law. and the like.
  • a magnetic therapy device which is a medical device having a device main body having an inlet for connecting an inlet connector, will be described.
  • the magnetic therapy apparatus 100 includes a device main body 101, a probe 102, a communication cable 103 that connects the probe 102 to the device main body 101, and a detachable insertion into the device main body 101. and a power cable (not shown) to be attached.
  • the magnetic therapy apparatus 100 of the present embodiment generates a signal wave for biostimulation, irradiates the affected part of the living body with a magnetic field generated by a coil with the signal wave for biostimulation, and stimulates the cells of the affected part. It is a magnetic therapy device with excellent drip-proof (IPX), electrostatic discharge/surge (ESD) and electromagnetic interference (EMS) countermeasures for treating pain.
  • IPX drip-proof
  • ESD electrostatic discharge/surge
  • EMS electromagnetic interference
  • the device body 101 included in the magnetic therapy device 100 has, for example, a signal wave output unit that generates and outputs a biostimulation signal wave of the first frequency.
  • the apparatus main body 101 includes a resin casing 104 and a touch input (capacitance) display 105 that is housed in the casing 104 obliquely upward and exposed from an opening 104 a on the front surface of the casing 104 .
  • a battery 106 for supplying a power source necessary for operating the magnetic therapy device 100 is installed inside the projecting portion 104 b on the rear lower side of the casing 104 . Note that the specifications of the battery 106 can be set as appropriate.
  • the magnetic therapy apparatus 100 is connected to a signal wave output section with a communication cable 103, and has a first coil supplied with a biostimulation signal wave of a first frequency output from the signal wave output section. and a probe 102 formed separately.
  • the probe 102 is a member for generating a magnetic field by applying it to the affected part of the living body when using the magnetic therapy apparatus 100 of the present embodiment, and irradiating the affected part with the magnetic field to treat the pain of the affected part.
  • the magnetic therapy device 100 may include at least one probe 102, and the number of probes 102 may be increased as needed.
  • the communication cable 103 may be configured integrally with the apparatus main body 101 and the probe 102, may be configured to be detachable (inlet) from the apparatus main body 101 and the probe 102, or may be configured separately. may be
  • the magnetic therapy apparatus 100 of this embodiment is provided with a probe 102 that is separate from the apparatus main body 101 . Therefore, by applying only the probe 102 to the affected part of the living body, for example, the affected part can be irradiated with the magnetic field generated by the first coil.
  • the probe 102 does not contain a signal wave generator and a power supply. Therefore, the probe 102 can be designed to be more compact than the device body 101 . As a result, when using the magnetic therapy device 100, the probe 102 does not become bulky, does not get caught on clothing, and does not come off from the affected area.
  • FIG. 2 is a front view showing the appearance of the device main body of the magnetic therapy device according to this embodiment.
  • an alarm stop button 107 and a power switch button 108 are provided on the left and right sides of the opening 104a on the front surface of the casing 104 of the main body 101 of the apparatus.
  • three sockets 109 for plugging the communication cables 103 are provided side by side to enable the connection of the three probes 102 to the device body 101. ing.
  • the number of sockets 109 can be appropriately set according to the number of probes 102 installed.
  • FIG. 3 is an enlarged cross-sectional view showing the relationship between the inlet and gasket provided in the magnetic therapy apparatus of this embodiment, and the inlet connector externally connected to the inlet.
  • An inlet connector connection casing opening 104c for connecting an inlet connector 110 from the outside of the apparatus main body 101 is provided in the casing 104 of the lower rear protrusion 104b of the casing 104 of the magnetic therapy apparatus 100 according to this embodiment.
  • An inlet connector 110 connected from the outside of the apparatus main body 101 is composed of an inlet connector outer peripheral portion 111 and an inlet connector inner peripheral portion 112 .
  • the inlet connector 110 is connected to the inlet 120 built in the projecting portion 104b by being inserted toward the inlet connector connecting casing opening 104c.
  • An inlet 120 for connecting the inlet connector 110 from the outside of the apparatus main body 101 is provided inside the projecting portion 104b. Furthermore, a gasket 140 designed to allow the inlet 120 to follow the shape of the inlet connector 110 is provided inside the protruding portion 104b.
  • the gasket 140 is provided on the inner wall of the gasket opening 141 and a gasket first sealing portion 144 that closely fits the inlet connector stepped end face 115 when the inlet connector 110 is pressed against the inlet 120 . It is characterized by having a gasket second sealing portion 147 that tightly fits with the inlet connector inner peripheral portion 112 by being pressed against.
  • the gasket 140 is interposed between the inlet opening 121 provided in the inlet 120 and the inlet connector connection casing opening 104c provided in the device main body 101 .
  • the inlet connector 110 When the inlet connector 110 is connected to the inlet 120 from the outside of the device main body 101, the inlet connector 110, the casing 104 of the projecting portion 104b, the gasket 140, the internal substrate 130, and the inlet 120 are connected from the outside of the device main body 101 toward the inside of the inlet 120.
  • These members are fitted in the order of the inlet 120 to keep the space formed between the inlet 120 and the inlet connector 110 sealed.
  • the magnetic therapy apparatus 100 of the present embodiment includes the gasket 140 designed so that the inlet 120 can follow the shape of the inlet connector 110 inside the projecting portion 104b. Airtightness can be secured.
  • the magnetic therapy apparatus of this embodiment can have a sufficiently drip-proof structure, and is excellent in countermeasures against electrostatic discharge/surge (ESD) and electromagnetic interference susceptibility (EMS).
  • An inlet connector 110 connected from the outside of the apparatus main body 101 is composed of an inlet connector outer peripheral portion 111 and an inlet connector inner peripheral portion 112 .
  • Inlet connector inner peripheral end surface 113 of inlet connector inner peripheral portion 112 is designed to be smaller than end surface 114 of inlet connector outer peripheral portion 111 so as to match the shape of the opening of inlet 120 . Therefore, due to the difference in size between inlet connector outer peripheral portion 111 and inlet connector inner peripheral portion 112 , inlet connector stepped end face 115 is formed at the connecting portion between inlet connector outer peripheral portion 111 and inlet connector inner peripheral portion 112 . formed.
  • the shape of the inlet connector inner peripheral end surface 113 of the inlet connector inner peripheral portion 112 is the shape of the inlet opening 121 where the normal inlet connector 110 connects with the inlet 120 .
  • the shape of the inlet connector inner peripheral end face 113 of the inlet connector inner peripheral part 112 may be designed to be smaller than the end face 114 of the inlet connector outer peripheral part 111, and may be substantially rectangular, substantially trapezoidal, substantially circular, or substantially elliptical. It may be of any shape, such as a shape.
  • the shape of the end surface 114 of the inlet connector outer peripheral portion 111 may be the same as or different from the shape of the inlet connector inner peripheral portion end surface 113 of the inlet connector inner peripheral portion 112. It may be of any shape, such as elliptical.
  • the inlet 120 has an inlet opening 121 and an inlet flange 122 on the outer edge of the inlet opening 121 .
  • the inlet flange 122 is formed with fastener holes 123 for attaching the internal substrate 130 .
  • An inlet electrical terminal 124 used for electrically connecting the inlet connector 110 and the inlet 120 is installed inside the inlet 120 .
  • the internal substrate 130 has therein an internal substrate opening 131 for allowing the inlet connector inner peripheral portion 112 of the inlet connector 110 to pass through.
  • the shape of the internal substrate opening 131 matches the inlet connector inner periphery end surface 113 of the inlet connector inner periphery 112 .
  • the internal substrate 130 is attached to the inlet flange 122 by fastener screws 132 via through holes formed in the internal substrate. As a result, the internal substrate 130 is tightly fitted to the inlet 120 without forming a gap and is fixed to the inlet 120 .
  • the gasket 140 is attached to the surface of the internal substrate 130 .
  • Gasket 140 has a gasket opening 141 therein for allowing inlet connector inner circumferential portion 112 of inlet connector 110 to pass therethrough.
  • a gasket outer edge portion 142 is provided on the outer edge of the gasket 140 .
  • a fastener screw housing portion 143 for receiving the fastener screw 132 protruding from the surface of the internal substrate 130 is formed on the rear surface of the gasket outer edge portion 142 .
  • the fastener screw 132 protrudes from the inner substrate 130 toward the casing 104 of the projecting portion 104b and has a convex shape.
  • the fastener screw 132 is fitted into the fastener screw housing portion 143 .
  • gasket 140 is fitted to internal substrate 130 without forming a gap, and is fixed to internal substrate 130 .
  • FIG. 4 is a schematic diagram showing the structure of the gasket provided in the magnetic therapy device of this embodiment.
  • FIG. 4(a) is a front perspective view
  • FIG. 4(b) is a back perspective view
  • FIG. 4(c) is a cross-sectional view taken along the line AA.
  • the gasket 140 has a first gasket seal portion 144 and a front convex portion 145 projecting toward the casing 104 of the projecting portion 104b.
  • the gasket first seal portion 144 and the gasket front convex portion 145 are formed in a substantially rectangular frame shape, and the gasket opening portion 141 is formed therein.
  • the gasket 140 has members formed in this order from the internal substrate 130 to the casing 104 direction of the protruding portion 104b in the gasket outer edge portion 142, the gasket first sealing portion 144, and the gasket front convex portion 145.
  • the gasket first seal portion 144 is formed so as to protrude toward the casing 104 from the projecting portion 104b.
  • the outer frame shape of the gasket front protrusion 145 matches the shape of the inlet connector connection casing opening 104c through which the inlet connector 110 passes. Therefore, the gasket front protrusion 145 can be fitted into the inlet connector connecting casing opening 104c.
  • the casing 104 of the protrusion 104b is tightly fitted without forming a gap and fixed to the gasket 140.
  • the gasket 140 has members formed in this order from the inlet 120 toward the casing 104 of the protruding portion 104b in the order of a gasket outer edge portion 142, a gasket first seal portion 144, and a gasket front convex portion 145. It has a gasket opening 141 .
  • the gasket opening 141 is formed with a gasket first opening 141a for allowing the inlet connector outer peripheral portion 111 of the inlet 110 to pass through, and a gasket second opening 141b for allowing the inlet connector inner peripheral portion 112 to pass therethrough.
  • the gasket opening 141 has a double structure of a first gasket opening 141a and a second gasket opening 141b.
  • the gasket opening 141 has two openings for passing the inlet connector outer peripheral portion 111 and the inlet connector inner peripheral portion 112 corresponding to different end faces of the inlet connector 110 .
  • the first gasket opening 141 a and the second gasket opening 141 b are separated by a gasket opening partitioning member 146 provided on the inner wall of the gasket opening 141 .
  • the gasket opening partitioning member 146 has an opening having the same shape as the inlet connector inner circumference end surface 113 of the inlet connector inner circumference 112, thereby forming the gasket second opening 141b.
  • FIG. 4(c) is a cross-sectional view of the gasket taken along line AA.
  • the gasket 140 has a first gasket sealing portion 144 and a second gasket sealing portion 147 .
  • the gasket first seal portion 144 has a frame shape and is formed over the entire circumferential direction of the gasket opening portion 141 .
  • the cross section of the first gasket seal portion 144 has a shape projecting in the casing direction of the casing projecting portion 104b.
  • the gasket first seal portion 144 is in pressure contact with the inlet connector step portion end surface 115 .
  • the inlet connector outer peripheral portion 111 passes through the gasket first opening 141a and is press-fitted in the direction of the inlet 120, the inlet connector step portion end surface 115 is closely fitted to the gasket first sealing portion 144 without forming a gap. . As a result, the gap formed between the inlet connector outer peripheral portion 111 and the gasket outer edge portion 142 is completely sealed by the gasket first seal portion 144 .
  • the device main body 101 of the magnetic therapy device 100 of this embodiment includes the gasket first seal portion 144 over the entire circumferential direction of the gasket opening portion 141, the inlet connector outer peripheral portion 111 and the gasket outer edge portion 142 can be sealed.
  • the inlet connector step end face 115 is pressed against and fixed to a gasket opening partitioning member 146 provided inside the gasket opening 141 .
  • the device main body 101 constituting the magnetic therapy device 100 of the present embodiment is provided with the first gasket sealing portion 144 in the gasket 140, so that the gap between the inlet connector outer peripheral portion 111 and the gasket outer peripheral portion 142 is Therefore, it is possible to effectively prevent moisture from entering through the gap formed in the circumferential direction of the gasket 140 .
  • the magnetic therapy device 100 of the present embodiment completely seals the gap formed in the circumferential direction of the gasket 140 by the gasket first seal portion 144, thereby effectively preventing moisture from entering the gap. can do.
  • the magnetic therapy device 100 of this embodiment is excellent in drip-proofness.
  • drip-proofness defines protection against dripping water.
  • drip-proofness is called an "IP (International Protection) code” and is evaluated according to the waterproof grade (IPX), which is the evaluation standard stipulated by the International Electro-technical Commission.
  • IPX International Protection
  • the waterproof rating (IPX) represents the protection performance against water and solid matter of a precision instrument such as a magnetic therapy device.
  • IPX The waterproof grade
  • IPX 1 provides protection against dripping water. Water is dripped vertically at a rate of 1 (mm/min) for 10 minutes using a water drip tester, and it is waterproof to confirm that there is no water intrusion into the magnetic therapy device.
  • IPX 2 provides protection against falling water when tilted at 15°.
  • a 3 (mm/min) water drop was applied to the magnetic therapy device at an angle of 15° with a water drop tester, and a water spray test was performed for 2.5 minutes in each direction for a total of 10 minutes, followed by magnetic therapy. It is waterproof so that it can be confirmed that there is no water intrusion into the vessel.
  • a waterproof rating (IPX) 3 provides protection against spray water. Specifically, with a watering device using an oscillating tube or a watering nozzle, water is sprinkled for 10 minutes at an angle of up to 60° on both sides from the vertical direction with a water amount of 0.07 (L / min) per each watering port, It is waterproof which can make sure that there is no water intrusion into the magnetic therapy device.
  • Waterproof rating (IPX) 4 provides protection against splashes. Using the above sprinkler equipment, sprinkle water from all angles with a water volume of 0.07 (L/min) per sprinkling port, and confirm that there is no water intrusion into the magnetic therapy device after at least 5 minutes of watering. It is waterproof.
  • a waterproof rating (IPX) 5 provides protection against water jets.
  • a water flow of 12.5 (L/min) discharged from a water nozzle of ⁇ 6.3 (mm) is sprinkled from all directions for 1 minute per 1m2 of outer skin surface area for a total of 3 minutes or more, and then to the magnetic therapy device. It is waterproof so that it can be confirmed that there is no flooding.
  • a waterproof rating (IPX) 6 provides protection against waves. Water flow of 100 (L/min) discharged from a water nozzle of ⁇ 12.5 (mm) is sprinkled from all directions for 1 minute per 1 m 2 of outer skin surface area for a total of 3 minutes or more, and the magnetic therapy device is flooded. You can be sure that it is not waterproof.
  • a waterproof rating (IPX) of 7 provides protection against immersion in water.
  • IPX waterproof rating
  • IPX8 waterproof grade
  • the waterproof grade (IPX8) magnetic therapy device must have a completely sealed structure. Since the magnetic therapy device 100 of the present embodiment can completely seal the gap formed in the circumferential direction of the gasket 140 by the first gasket sealing portion 144, it has a drip-proof property of at least a waterproof grade (IPX) of 1 or higher. Prepare.
  • the magnetic therapy device 100 of the present embodiment changes the shape and material of the gasket first sealing portion 144 to more completely seal the gap formed in the circumferential direction of the gasket 140, thereby improving the waterproof grade (IPX ) with a drip resistance of 2 to 8.
  • the magnetic therapy device 100 of this embodiment has not only waterproof performance but also protection against humidity.
  • the gasket 140 has a gasket second sealing portion 147 .
  • the inlet connector inner peripheral portion 112 passes through the second gasket opening 141 b and is press-fitted toward the inlet 120 , the inlet connector inner peripheral side surface 116 of the inlet connector inner peripheral portion 112 and the gasket second seal portion 147 are pressed together. Close fit without forming a gap. As a result, the gap formed between the inlet connector inner peripheral side surface 116 of the inlet connector inner peripheral portion 112 and the gasket opening 141 is completely sealed by the gasket second sealing portion 147 .
  • the shape of the gasket second seal portion 147 is not particularly limited as long as it is formed to protrude from the inlet connector inner peripheral portion 112 toward the inlet connector inner peripheral portion side surface 116 .
  • a plurality of second gasket seal portions 147 may be provided facing the inner wall of the gasket opening portion 141 . That is, the position and the number of the second gasket seal portions 147 can be appropriately set according to the shape of the inlet connector inner peripheral end surface 113 of the inlet connector inner peripheral portion 112 . For example, when the inlet connector inner peripheral end surface 113 of the inlet connector inner peripheral portion 112 has a substantially trapezoidal shape, four gaskets in total are installed at the opposite upper, lower, left and right positions of the trapezoidal shape.
  • the material of the gasket 140 is not particularly limited as long as it has excellent workability, water repellency, and electrostatic discharge (ESD) countermeasure performance.
  • ESD electrostatic discharge
  • the gasket 140 for example, natural rubber, nitrile rubber (NBR), butyl rubber, silicon rubber, fluororubber, EPDM, fluororubber, PTFE (tetrafluoroethylene resin, Teflon (registered trademark) resin), polyetheretherketone, Polyphenylene sulfide, polyoxymethylene and the like can be mentioned.
  • FIG. 5 is a schematic diagram showing the state before and after the inlet connector is connected to the inlet included in the magnetic therapy apparatus of this embodiment.
  • FIG. 5(a) is a sectional view showing a state before the inlet connector is connected to the inlet.
  • the inlet 120 has an inlet connector accommodating portion 126 for holding the inlet connector 110 in the connected state.
  • the inlet connector housing portion 126 having a box-like shape is provided with an inlet side wall 128 that faces the inlet opening 121 and connects an inlet bottom wall 127 located at the innermost position of the inlet connector housing portion 126 and an outer peripheral edge thereof.
  • the inlet connector housing portion 126 is provided with inlet electrical terminals 124 and 125 for power lines, ground lines, signal lines, and the like. These electrical terminals serve as electrical contact points between the device main body 101 and the inlet connector 110 .
  • a gasket 140 is attached to the inlet 120 via the inlet opening 121 and the internal substrate 130 .
  • the gasket 140 has a first gasket sealing portion 144 and a second gasket sealing portion 147 .
  • FIG. 5(b) is a sectional view showing the state after the inlet connector 110 is connected to the inlet 120.
  • FIG. 5(b) when the inlet connector 110 is inserted into the inlet connector housing portion 126, the inlet connector inner peripheral portion 112 is fitted with the inlet side wall 128. As shown in FIG. Further, the inlet connector inner peripheral end surface 113 of the inlet connector inner peripheral portion 112 fits into the inlet bottom wall 127, thereby maintaining the electrical connection between the inlet connect 110 and the inlet 120.
  • the end surface 114 of the inlet connector outer peripheral portion 111 is tightly fitted with the gasket first seal portion 144 to seal the inlet 120 in the circumferential direction.
  • the side surface of the inlet connector inner peripheral portion 112 is tightly fitted with the gasket second seal portion 147 to seal the inlet 120 in the end face direction.
  • the device main body 101 of the magnetic therapy device 100 of the present embodiment since the device main body 101 of the magnetic therapy device 100 of the present embodiment includes the second gasket seal portion 147 inside the gasket opening portion 141, the inlet 120 can be sealed in the end face direction. That is, the device main body 101 constituting the magnetic therapy device 100 of the present embodiment is provided with the second gasket opening 147 inside the gasket opening 141 so that the inlet connector inner peripheral side surface 116 of the inlet connector inner peripheral portion 112 is and the gasket opening 141, the gap formed in the direction of the inlet 120 is completely sealed in the end face direction to effectively prevent electrostatic discharge/surge (ESD) and electromagnetic interference susceptibility (EMS). can be harvested.
  • ESD electrostatic discharge/surge
  • EMS electromagnetic interference susceptibility
  • ESD test electrostatic discharge test
  • HBM method human body model method
  • MM method machine model method
  • CDM method device charging model method
  • the human body model method is a test that simulates the case where static electricity is discharged from the human body to the magnetic therapy device 100.
  • An electrostatic discharge test (ESD test) was performed with a capacitor capacity of 100 pF and an electrical resistance of 1.5 K ⁇ . ).
  • the machine model method (MM method) is a test that simulates the case where static electricity is discharged from the machine to the magnetic therapy device 100, and is an electrostatic discharge test (ESD test) in which the capacitor capacity is set to 200 pF and the electrical resistance is set to 0 ⁇ . ).
  • the electrification model method is a test that simulates the case where the magnetic therapy device 100 itself is charged and static electricity is discharged, and is an electrostatic discharge test (ESD test) when static electricity is applied once. Since the magnetic therapy device 100 of the present embodiment includes the gasket second sealing portion 147 inside the gasket opening portion 141, it has sufficient electrostatic discharge resistance for these electrostatic discharge tests (ESD tests). . In particular, the device main body 101 of the magnetic therapy device 100 of this embodiment has an air electrostatic discharge resistance of ⁇ 15 kV or more. Electrostatic discharges that actually occur when using medical equipment are air discharges through air gaps.
  • air discharge is affected by the temperature, humidity, the speed at which the human body approaches the medical device, the shape of the metal object worn by the person, the shape of the discharge target, etc. when using the medical device. Due to this, the discharge becomes unstable. Therefore, a medical device having an air electrostatic discharge resistance of ⁇ 15 kV or more has sufficient electrostatic discharge resistance against a contact discharge of about ⁇ 8 kV.
  • the device main body 101 of the magnetic therapy device 100 of the present embodiment includes the first gasket sealing portion 144 and the second gasket sealing portion 147 in the gasket 140, it is drip-proof (IPX), It is excellent in surge (ESD) countermeasures and electromagnetic interference (EMS) countermeasures.
  • IPX drip-proof
  • ESD surge countermeasures
  • EMS electromagnetic interference countermeasures.
  • the magnetic therapy device 100 of the present embodiment is interposed between the inlet opening 121 provided in the inlet 120 and the inlet connector connection casing opening 104c provided in the apparatus main body 101, and the inlet connector 110 Since the gasket 140 is formed so that the inlet 120 can follow the shape of , the inside of the inlet can be completely sealed.
  • the magnetic therapy device 100 of the present embodiment is excellent in drip-proofness (IPX), electrostatic discharge/surge (ESD) countermeasures, and electromagnetic interference susceptibility (EMS) countermeasures.
  • the medical device of the present invention is not limited to the above-described embodiments, and can be appropriately modified within the scope of the claims. That is, in the device main body 101 provided in the magnetic therapy device 100, which is an example of the medical device according to the present embodiment, the signal wave output unit generates a biostimulation signal wave with a first frequency and a signal wave with a second frequency. may be changed as appropriate.
  • the device main body 101 included in the magnetic therapy device 100 of the present embodiment may have a signal wave output unit that generates and outputs a biostimulation signal wave of the first frequency.
  • the variation in the frequency of the biostimulation signal wave of the first frequency output from the signal wave output unit is within a predetermined range with a center frequency of 250 MHz.
  • the signal wave output unit generates and outputs the biostimulation signal wave of the second frequency
  • the second signal wave output from the signal wave output unit It may have a second coil to which a two-frequency biostimulation signal wave is supplied.
  • a high-frequency alternating magnetic field is generated from the high-frequency signal wave. Since the generated high-frequency alternating magnetic field has a high effect of activating damaged sensory cells and inducing neurotrophic factors, it can be expected to increase the effect of alleviating neuropathy in the affected area. Also, by setting the signal wave for biostimulation of the second frequency to a low frequency signal wave for biostimulation of 1 KHz or more and 3 KHz or less, a low frequency alternating magnetic field is generated from the low frequency signal wave. The generated low-frequency alternating magnetic field is particularly likely to reach the brain from the dorsal horn of the spinal cord via sensory nerves, and is therefore expected to bring about a higher analgesic effect, a relaxing effect, and other neuropathy-reducing effects.
  • the gasket that allows the inlet to follow the shape of the inlet connector ensures the sealing of the inlet portion, and is drip-proof (IPX), measures against electrostatic discharge/surge (ESD), and electromagnetic interference.
  • IPX drip-proof
  • ESD electrostatic discharge/surge
  • EMS electromagnetic interference susceptibility

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  • Engineering & Computer Science (AREA)
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  • General Engineering & Computer Science (AREA)
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  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
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  • Life Sciences & Earth Sciences (AREA)
  • General Health & Medical Sciences (AREA)
  • Mechanical Engineering (AREA)
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  • Medicinal Chemistry (AREA)
  • Chemical & Material Sciences (AREA)
  • Physics & Mathematics (AREA)
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  • Magnetic Treatment Devices (AREA)
PCT/JP2023/003981 2022-02-18 2023-02-07 医療機器 Ceased WO2023157718A1 (ja)

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EP23756245.9A EP4480534A4 (en) 2022-02-18 2023-02-07 Medical device
US18/839,179 US20250152958A1 (en) 2022-02-18 2023-02-07 Medical apparatus
JP2024501311A JPWO2023157718A1 (https=) 2022-02-18 2023-02-07

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JPH11333002A (ja) * 1998-05-28 1999-12-07 Nec Corp 生体刺激装置
WO2008056414A1 (en) 2006-11-08 2008-05-15 Medical Appliance Co., Ltd. Neurotrophic factor production accelerating apparatus
JP2009531156A (ja) * 2006-03-29 2009-09-03 カソリック ヘルスケア ウエスト 患者の心周期による迷走神経刺激の同期化
JP2016515869A (ja) * 2013-03-15 2016-06-02 エムキネティクス，インコーポレイテッド 手のひら及び足底の表面上での経皮的な刺激のための方法及び装置

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JP2017064040A (ja) * 2015-09-30 2017-04-06 Hoya株式会社 内視鏡プロセッサ及び内視鏡接続システム
CN109381792B (zh) * 2018-11-09 2024-06-21 南方医科大学中西医结合医院 一种家用便捷型磁场刺激仪
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KR20220017192A (ko) * 2020-08-04 2022-02-11 삼성전자주식회사 센서 모듈을 포함하는 전자 장치

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JPH11333002A (ja) * 1998-05-28 1999-12-07 Nec Corp 生体刺激装置
JP2009531156A (ja) * 2006-03-29 2009-09-03 カソリック ヘルスケア ウエスト 患者の心周期による迷走神経刺激の同期化
WO2008056414A1 (en) 2006-11-08 2008-05-15 Medical Appliance Co., Ltd. Neurotrophic factor production accelerating apparatus
JP2016515869A (ja) * 2013-03-15 2016-06-02 エムキネティクス，インコーポレイテッド 手のひら及び足底の表面上での経皮的な刺激のための方法及び装置

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Title
See also references of EP4480534A4

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EP4480534A4 (en) 2025-05-28

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