Classifications

• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61N—ELECTROTHERAPY; MAGNETOTHERAPY; RADIATION THERAPY; ULTRASOUND THERAPY
  • A61N7/00—Ultrasound therapy

Definitions

• the present invention relates to an ultrasonic therapy device for treating dementia and other conditions by irradiating ultrasonic waves.
• the number of dementia patients in Japan is said to be around 2.6 million, and in the future, as the elderly population rapidly increases, this number is expected to increase, exceeding 6.75 million by 2025.
• the number of dementia patients worldwide is estimated at 35 million, with provisional calculations predicting this number will reach 65 million in 2030 and 115 million in 2050.
• vascular dementia and Alzheimer's dementia account for the majority of all dementia cases, and there are many patients who exhibit symptoms of both.
• Measures taken to treat vascular dementia include drug therapy for high blood pressure, dyslipidemia, and diabetes, as well as reducing lack of exercise, smoking, overeating, and stress, but no medicines have yet been developed to treat vascular dementia itself. Additionally, for Alzheimer's disease, drugs that activate the acetylcholine pathway and inhibit glutamate are commercially available, but the therapeutic effects of these drugs are not necessarily sufficient. Therefore, there is a need to develop effective means of treating dementia.
• LIPUS Low-Intensity Pulsed Ultrasound
• Non-Patent Document 1 LIPUS has attracted widespread attention in the fields of orthopedics, gastroenterology, neurology, dentistry, and other fields, and has already been put to clinical use in the treatment of fractures.
• Patent Document 1 describes a headset for an ultrasound diagnostic device, which includes an ultrasound probe holding means for holding an ultrasound probe, and a moving and fixing means for holding the ultrasound probe holding means and moving the ultrasound probe holding means in three dimensions to the irradiation position of the subject and fixing it there.
• Patent Document 1 describes the structure of a headset that is worn on the head, it is not a headset that holds a convex curved transducer that irradiates ultrasound to the temporal bone.
• Patent Document 2 describes a device for treating dementia that uses a curved, convex-shaped transducer to irradiate the entire brain, and includes multiple ultrasound probes, ultrasound transducers that are placed on the ultrasound probes and transmit unfocused ultrasound energy to the brain, and an ultrasound generator connected to the ultrasound probes.
• Patent Document 2 does not describe a method for simply and accurately fixing the ultrasound transducers to the temporal bone, and does not describe appropriate positioning since head sizes vary from subject to subject.
• Patent document 3 describes an ultrasound device configured to ensure that a predetermined portion of the cerebral vasculature is reliably and predictably insonified from an ultrasound transducer when the system is positioned on the subject's head, even without feedback from a clinician.
• the ultrasound transducer described in patent document 3 is not convex, and the headset is simply worn on the bridge of the subject's nose in contact with the nasion.
• Patent Document 4 describes an ultrasound stimulation helmet that adjusts the expression levels of endogenous neurotrophic factors and neurodegenerative disease-related proteins in the brain, and is used to prevent and treat brain diseases such as neurodegeneration.
• the ultrasound stimulation helmet described in Patent Document 4 is adjusted in position using multiple position adjustment buttons, such as a forehead circumference adjustment button, and the ultrasound probe is not convex.
• the present invention was made in consideration of these problems, and aims to provide an ultrasound treatment device that can accurately fix an ultrasound transducer to the temporal bone of a subject (also called a patient) even when the head size differs depending on the subject or when the subject moves during measurement, and that can be easily attached without putting any burden on the subject.
• the ultrasonic treatment device (100) of the present invention is an ultrasonic treatment device (100) that irradiates ultrasonic waves to the brain of a subject, and includes two convex curved transducers (8A, 8B) that irradiate the brain of the subject with unfocused ultrasonic energy in an inverse tapered shape that gradually expands in the radiation direction, and a headset (20) that is connected to the convex curved transducers (8A, 8B) and is attached to the head of the subject when energy for ultrasonic vibration is supplied to the transducers, and the headset (20) includes a headband portion (21) that is attached circumferentially to the head of the subject, and a headband portion (22) that is attached in an approximately arch shape above the headband portion (21) to cover the head of the subject.
• the headband part (21) is characterized by comprising: a hard holder (22) that is arc-shaped in a plan view and fixes the convex curved transducers (8A, 8B) to the left and right sides of the subject's head; a frontal band (23) that has a length adjustment mechanism (230) that adjusts the length of the headband part (21) according to the size of the subject's temporal bone; and a back of the head band (24) that has a pressure adjustment mechanism (240) that adjusts the tightening pressure of the headband part (21) on the subject.
• the ultrasound transducer can be accurately fixed to the subject's temporal bone even when subjects have different head sizes or when the subject moves during measurement. It can also be easily attached without putting any strain on the subject.
• FIG. 1 is a diagram illustrating an entire ultrasonic treatment device according to the present invention.
• FIG. 1 is an external view of a headset attached to a subject's head, which is a characteristic feature of the invention.
• FIG. FIG. 13 is a diagram showing the appearance of a convex curved surface vibrator before it is attached to a vibrator attachment portion.
• FIG. 13 is a diagram showing the appearance of the convex curved surface vibrator after it has been attached to the vibrator attachment portion.
• 1 is a diagram illustrating the left side of the headset from the side of the hard holder that contacts the left temporal region of the subject and the convex curved vibrator housed in the hard holder.
• FIG. 1 is a diagram illustrating the right side of the headset from the side of the hard holder that contacts the subject's right temporal region and the convex curved transducer housed in the hard holder.
• FIG. 1A is a diagram illustrating the length adjustment mechanism provided on the forehead band, showing the state in which it can slide before it is locked
• FIG. 1B is a diagram illustrating the length adjustment mechanism provided on the forehead band, showing the state in which it cannot slide after it is locked.
• 1A is a diagram for explaining the state of connecting the first forehead band to the forehead band connecting portion, showing the state before the connection
• FIG. 1B is a diagram for explaining the state of connecting the first forehead band to the forehead band connecting portion, showing the state after the connection.
• 13A and 13B are diagrams illustrating a pressure adjustment mechanism provided in the rear head band.
• FIG. 1 is an external view of a prototype headset 20.
• the ultrasound treatment device 100 of the present invention is a treatment device that irradiates ultrasound waves to the subject's brain.
• the ultrasonic therapy device 100 has two convex curved transducers 8A and 8B, a transmitter (7) connected to the convex curved transducers 8A and 8B to supply energy for ultrasonic vibrations, and a headset 20 attached to the subject's head.
• the ultrasound therapy device 100 transmits ultrasonic frequencies and irradiates the brain using LIPUS (Low-Intensity Pulsed Ultrasound), which can treat, for example, dementia by increasing the expression of eNOS (endothelial nitric oxide synthase) and VEGF.
• Dementia includes vascular dementia, Alzheimer's dementia, and symptoms that show both. Dementia also includes symptoms such as mild cognitive impairment (MCI).
• eNOS endothelial nitric oxide synthase
• eNOS endothelial nitric oxide synthase
• NOS3 gene located in the 7q35-7q36 region of chromosome 7 in humans, and this enzyme is one of the three nitric oxide synthases that synthesize nitric oxide (NO).
• the two convex curved transducers 8A and 8B irradiate the subject's brain with unfocused ultrasound energy in an inverted tapered shape that gradually expands in the direction of radiation.
• the convex curved transducers 8A and 8B have a convex curved shape on the ultrasound irradiation surface, which allows the direction of ultrasound to be unfocused, making it possible to irradiate the entire target area.
• the transducers can be piezoelectric elements, PVDF, BaTi23, PIN-PmN-PT, or other piezoelectric elements, or those using semiconductor processes called CMUT or PMUT.
• unfocused ultrasonic energy means ultrasonic energy that is diffused without being focused to a single point or line.
• Unfocused ultrasonic energy diffuses in an inverted tapered shape that gradually expands in the direction of radiation, and the angle of the inclined surface of the expanding inverted tapered unfocused ultrasonic energy is preferably 50° to 100°, and more preferably 60° to 90°.
• ultrasonic energy is diffused in an approximately conical shape (the bottom portion can be curved).
• Two convex curved transducers 8A and 8B are placed on the temporal region of the subject.
• By diffusing the unfocused ultrasonic energy in an inverse tapered shape it is possible to transmit ultrasonic energy to a large portion of the brain, for example, a portion including at least the hippocampus and corpus callosum, and typically to the entire brain.
• the system 10 is configured with a device input unit for inputting the treatment area 2 and subject information 3, a management system having a control unit 4, a transmission condition control unit 5, a treatment protocol control unit 6, a transmission unit 7, and a display 9.
• the transmission unit 7 is connected to the convex spherical curved transducers 8A and 8B to supply energy for ultrasonic vibration.
• the treatment information input by the operator 1, such as the treatment area 2 and subject information 3, is transmitted to the transmission condition control unit 5 and treatment protocol control unit 6 by the control unit 4, which serves as a protocol management system within the device, and the transmission conditions and treatment protocol are transmitted from the transmission unit 7.
• the control unit 4 which serves as a protocol management system within the device, and the transmission conditions and treatment protocol are transmitted from the transmission unit 7.
• unfocused ultrasonic energy is irradiated to the target area by the convex curved transducers 8A and 8B. In this way, the frequency, time, timing, etc. of the vibration of the convex curved transducers 8A and 8B are controlled by the system 10.
• the amplitude (sound pressure) of the irradiated ultrasound is preferably low, for example, 0.5 MPa or less, more preferably 0.3 MPa or less, from the viewpoint of promoting angiogenesis, neuronal increase, etc., by gentle ultrasound stimulation.
• the lower limit of the intensity of the irradiated ultrasound is not particularly limited in the present invention, but from the viewpoint of therapeutic effectiveness, it is preferably, for example, 0.05 MPa or more, preferably 0.1 MPa or more.
• the intensity of the ultrasound and the frequency of the irradiated ultrasound are not particularly limited, but can be appropriately set, for example, in the range of 0.5 to 1.5 MHz, preferably 0.5 to 1.0 MHz.
• the ultrasonic transducers 8A and 8B in order to prevent the ultrasonic energy irradiated from the convex curved transducers 8A and 8B from being transmitted to the brain in a redundant manner, resulting in excessive ultrasonic energy being transmitted to the brain, it is preferable to control the ultrasonic transducers so that unfocused ultrasonic energy is irradiated sequentially between the convex curved transducers 8A and 8B.
• the ultrasound waves generated from the convex curved transducers 8A and 8B pass through the skull, are transmitted to the brain, and are reflected by the skull on the opposite side and transmitted again. The reflected ultrasound waves are then reflected again and transmitted. During this time, the ultrasound waves are attenuated as they propagate through the brain and as they are reflected by the skull. In this way, the ultrasound waves generated from the convex curved transducers 8A and 8B travel back and forth within the brain multiple times, attenuating each time they are reflected by the skull.
• the interval of unfocused ultrasonic energy irradiation means, in the above sense, the time from the cessation of ultrasonic irradiation from one transducer 8A to the start of ultrasonic irradiation from the next transducer 8B when ultrasonic irradiation is started from one transducer 8A, then stopped, ultrasonic irradiation is started from the next transducer 8B, then ultrasonic irradiation is stopped again, and so on.
• the irradiated ultrasonic waves are discontinuous waves, and the number of cycles is not particularly limited, but can be set appropriately within the range of, for example, 1 to 64 cycles, and preferably 24 to 40 cycles.
• the number of ultrasonic cycles refers to the number of cycles within the range from the start of ultrasonic irradiation to the end of ultrasonic irradiation (also referred to as the pulse width in this specification).
• Fig. 2 is an external view of a headset 20 attached to the subject's head, which is a characteristic feature of the present invention.
• the headset 20 has a headband portion 21 that is attached circumferentially to the subject's head, and upper and lower fixing bands 25 that are attached in a generally arched shape above the headband portion 21 and have a curved shape that fits along the subject's head near the forehead.
• the upper and lower fixing bands 25 prevent the headband portion 21 from shifting in position in the vertical direction.
• the upper and lower fixing bands 25 are preferably inclined forward by 30° to 60° relative to the headband portion 21 in a side view.
• the headband part 21 is made up of a hard holder 22 that fixes the convex curved transducers 8A and 8B to the left and right sides of the subject's head, a forehead band 23 that has a length adjustment mechanism 230 and comes into contact with the subject's forehead, and an occipital band 24 that has a pressure adjustment mechanism 240 and a length adjustment mechanism 246 and comes into contact with the occipital region of the subject.
• the length adjustment mechanism 230 (also referred to as the front length adjustment mechanism 230) adjusts the length of the headband part 21 according to the size of the subject's temporal bone.
• the pressure adjustment mechanism 240 adjusts the tightening pressure of the headband part 21 on the subject.
• the length adjustment mechanism 246 (also referred to as the rear length adjustment mechanism 246) is used to adjust to the overall size of the subject's head.
• the hard holder 22 is made of a hard material such as a metal material so that the convex curved transducers 8A and 8B can be properly fixed to the left and right sides of the subject's head, while the forehead band 23, occipital band 24, and upper and lower fixing bands 25 are made of a flexible material so that they can be flexibly attached to subjects of various body sizes.
• the upper and lower fixing bands 25, the front head band 23, and the rear head band 24 are preferably made of a flexible material having a bending rigidity of 0.1 N ⁇ m 2 or more and 1.5 N ⁇ m 2 or less.
• Such flexible materials are not particularly limited, but examples include polyethylene, polypropylene, polystyrene, acrylonitrile-styrene resin, acrylonitrile-butadiene-styrene resin, polyvinyl chloride, methacrylic resin, polyethylene terephthalate resin, polyurethane, polycarbonate, silicone, natural rubber, or composite resins of these.
• Figure 3 is an external view of the hard holder 22.
• the hard holder 22 has an arc shape in a plan view, and this arc shape has a curved shape that can fit closely to the subject's temporal region, with the radius of curvature preferably being in the range of 90mm-300mm.
• the head circumference of elderly men and women is 499-618mm within the 3 ⁇ range, and if the head circumference is considered to be a circle, the radius of curvature is 79-98mm, but since the area near the temporal bone has a relatively flat shape, it has a larger radius of curvature than the radius of curvature expected from the head circumference. Also, if it were completely flat, there would be a large gap with the head, causing the transducer to shift position.
• the hard holder 22 is connected to the forehead band 23, the occipital band 24, and the upper and lower fixing bands 25, so the hard holder 22 is provided with a forehead band connection part 223 which is the end that connects to the forehead band 23, an occipital band connection part 224 which is the end that connects to the occipital band 24, and an upper and lower fixing band connection part 225 which is the end that connects to the upper and lower fixing bands 25.
• the hard holder 22 is provided with a transducer mounting portion 221 capable of housing the convex curved transducer 8A.
• the material of the convex curved transducer 8A is not particularly limited as long as it can generate the above-mentioned unfocused ultrasonic energy, but examples include PZT (lead zirconate titanate) and PVDF (polyvinylidene fluoride).
• FIG. 4 is a diagram showing the appearance of the convex curved vibrator 8A before it is attached to the vibrator mounting portion 221.
• the shape of the convex curved vibrator 8A is approximately circular, but it is not limited to this shape and can be designed as appropriate, for example, approximately elliptical, polygonal (triangle, quadrangle (square, rectangle, parallelogram, trapezoid, etc.), pentagon, hexagon, heptagon, octagon, etc.).
• the size of the convex curved vibrator 8A is not particularly limited, but for example, if the shape is approximately circular, the diameter is preferably 1.0 to 5.0 cm, and more preferably 2.0 to 4.0 cm.
• the convex curved vibrator 8A has a shape that allows it to be positioned in a location other than the radiation surface.
• the shape can be convex, concave, flat, etc.
• the hard holder 22 must be made of a highly rigid material to secure the convex curved vibrator. It has a receiver shape that matches the shape for positioning the vibrator.
• the shape of the transducer mounting portion 221 is not particularly limited as long as it can accommodate the convex curved transducer 8A without any gaps. If the shape of the convex curved transducer 8A is approximately circular, the shape of the transducer mounting portion 221 will also be a roughly circular cup shape.
• FIG. 5 is a diagram showing the appearance of the convex curved transducer 8A after it has been attached to the transducer mounting portion 221.
• the transducer mounting portion 221 closely houses the convex curved transducer 8A, and the convex curved ultrasound irradiation surface of the convex curved transducer 8A is exposed from the transducer mounting portion 221. This allows unfocused ultrasound energy to be efficiently transmitted from the convex curved transducer 8A to the subject's brain.
• the convex curved vibrator 8A and the hard holder 22 may be attached permanently or semi-permanently with adhesive, or may be attached with screws or a locking mechanism, etc.
• FIG. 6 is a diagram illustrating the left side of the headset 20 from the side of the hard holder 22 that abuts against the left temporal region of the subject and the convex curved vibrator 8A housed in the hard holder 22.
• a first frontal band 231 is connected to the frontal band connection part 223
• a second occipital band 242 is connected to the occipital band connection part 224
• a first upper and lower fixed bands 251 are connected to the upper and lower fixed band connection part 225.
• the first upper and lower fixed bands 251 are provided with a length adjustment mechanism 250 (also referred to as an upper length adjustment mechanism 250) that adjusts the length of the upper and lower fixed bands 25.
• FIG. 7 is a diagram illustrating the right side of the headset 20 from the side of the hard holder 22 that abuts against the subject's right temporal region and the convex curved vibrator 8B housed in the hard holder 22.
• a second forehead band 232 is connected to the forehead band connection part 223
• a first occipital band 241 is connected to the occipital band connection part 224
• second upper and lower fixed bands 252 are connected to the upper and lower fixed band connection part 225.
• the forehead band 23 consists of a first forehead band 231 attached to one of the hard holders 22 (left side) and a second forehead band 232 attached to the other hard holder 22 (right side).
• the occipital band 24 consists of a second occipital band 242 attached to one of the hard holders 22 (left side) and a first occipital band 241 attached to the other hard holder 22 (right side).
• the upper and lower fixing bands 25 consist of a first upper and lower fixing band 251 provided on one of the hard holders 22 (left side) and a second upper and lower fixing band 252 provided on the other hard holder 22 (right side).
• FIG. 8(A) is a diagram explaining the length adjustment mechanism 230 provided on the forehead band 23, and shows the state in which it can slide before it is locked.
• FIG. 8(B) is a diagram explaining the length adjustment mechanism 230 provided on the forehead band 23, and shows the state in which it cannot slide after it is locked.
• the tip end of the first forehead band 231 has multiple engagement recesses 233 spaced at regular intervals in the longitudinal direction.
• the tip end of the second forehead band 232 has an engagement protrusion 234 that can be detached from the engagement recess 233.
• the engagement protrusion 234 is fitted into any position of the engagement recess 233 and locked, thereby fixing the engagement recess 233 and adjusting the length.
• the length adjustment mechanism 230 provided on the forehead band 23 allows the length to be adjusted according to the size of the subject's temporal bone.
• the tip end of the first occipital band 241 has a plurality of engagement recesses 243 spaced at regular intervals in the longitudinal direction.
• the tip end of the second occipital band 242 has an engagement protrusion 244 that can be attached to and detached from the engagement recess 243.
• the length adjustment mechanism 246 adjusts the length by locking the engagement protrusion 244 into any position of the engagement recess 243.
• the locking mechanism of the length adjustment mechanism 246 is the same as that of the length adjustment mechanism 230.
• the length adjustment mechanism 246 provided on the occipital band 24 allows the overall size to be adjusted to fit the size of the subject's head.
• the tip end of the first upper and lower fixing band 251 has a plurality of engagement recesses 253 spaced at regular intervals in the longitudinal direction.
• the tip end of the second upper and lower fixing band 252 has an engagement protrusion 254 that can be attached to and detached from the engagement recess 253.
• the length adjustment mechanism 250 adjusts the length by locking the engagement protrusion 254 into any position of the engagement recess 253.
• the locking mechanism of the length adjustment mechanism 250 is the same as that of the length adjustment mechanism 230.
• the length adjustment mechanism 250 provided on the upper and lower fixing bands 25 allows the size to be adjusted so that there is no vertical misalignment after the length of the forehead band 23 and the occipital band 24 is adjusted.
• the range of adjustment can be specified as follows. According to the database (https://www.airc.aist.go.jp/dhrt/head/index.html), the head circumferences of elderly men and elderly women are calculated using 3 ⁇ to be 525-618mm and 499-593mm, respectively. If the headgear is to be used by both men and women, an adjustment range of at least 100mm is required.
• the head width for elderly men and elderly women calculated using 3 ⁇ is 139-178mm and 137-167mm, respectively, which requires an adjustment range of at least 40mm.
• the adjustment range of the forehead band 23 must be at least 40 mm, and the combined adjustment range of the forehead band 23 and the occipital band 24 must be at least 100 mm.
• the upper and lower fixing bands 25, like the forehead band 23, have an adjustment range of at least 40 mm. Although no data from Europe or the United States is listed, it is thought that their heads are larger than those of Japanese people.
• FIG. 9(A) is a diagram for explaining the state of connecting the first forehead band 231 to the forehead band connection part 223, and shows the state before connection.
• FIG. 9(B) is a diagram for explaining the state of connecting the first forehead band 231 to the forehead band connection part 223, and shows the state after connection.
• a fitting protrusion 238 is provided at the end on the base end side of the first forehead band 231.
• a fitting recess 239 capable of receiving the fitting protrusion 238 is provided at the forehead band connection portion 223.
• attachment is possible by pressing the fitting protrusion 238 into the fitting recess 239 with a physical force. Note that in addition to fixing by the physical fitting force between the fitting recess and the fitting protrusion, it can also be fixed by screws or adhesively using a specified adhesive.
• This mounting structure is also the same when connecting the second forehead band 232 to the forehead band connection part 223. It is also the same when connecting the second occipital band 242 to the occipital band connection part 224. It is also the same when connecting the first upper and lower fastening bands 251 to the upper and lower fastening band connection part 225. It is also the same when connecting the second upper and lower fastening bands 252 to the upper and lower fastening band connection part 225.
• the rear head band connection part 224 and the first rear head band 241 are not connected using the aforementioned fitting protrusion and fitting recess.
• FIG. 10 is a diagram illustrating the pressure adjustment mechanism 240 provided on the occipital band 24.
• a pressure adjustment rubber hook 247 is provided at the end of the first occipital band 241.
• a pressure adjustment rubber hook 247 is also provided at the occipital band connection part 224 of the hard holder 22.
• a pressure adjustment rubber 246 is hooked onto both pressure adjustment rubber hooks 247. In this way, the occipital band connection part 224 and the first occipital band 241 are connected by the pressure adjustment rubber 246.
• the duration of ultrasonic treatment is not particularly limited, but can be set appropriately within a range of 1 to 60 minutes, preferably 15 to 25 minutes, per treatment, depending on the patient's symptoms, the strength of the ultrasonic waves, etc.
• the number of times the treatment is performed per day is also not particularly limited, but can be set appropriately within a range of 1 to 4 times, preferably 2 to 3 times.
• the frequency of the treatment is also not particularly limited, and can be set appropriately within a range of 1 to 7 times, preferably 2 to 3 times per week.
• the treatment interval is also not particularly limited, and for example, if one set of treatment is performed for 5 to 10 days (more preferably 6 to 8 days) at the above frequency, it is preferable to perform the treatment continuously at intervals of once every 1 to 4 months (for example, once every 1 to 3.5 months) unless an adverse event occurs.
• the intensity of the ultrasonic waves can be adjusted by I SPPA , I SPTA , etc.
• I SPPA indicates the average intensity within the pulse width
• I SPTA indicates the average intensity within the repetition period.
• the I SPTA of the irradiated ultrasound is not particularly limited, but from the viewpoint of promoting angiogenesis, neuronal increase, etc. by gentle ultrasound stimulation, it can be appropriately set, for example, to 200 mW/ cm2 or less, preferably in the range of 10 to 150 mW/ cm2 .
• the patient's treatment position may be sitting in a chair, or lying down for separate treatment.
• the device By making the device smaller, it may also be possible to use it during daily life, such as when walking. In either case, there is a possibility that the patient may move, so it is important that the device remains in place throughout the treatment period.
• a headset 20 was produced.
• the convex curved transducers 8A and 8B used piezoelectric elements, and the angle of the inclined surface of the expanding inverse tapered unfocused ultrasonic energy was 60°.
• the convex curved transducers 8A and 8B were attached to a hard holder 22.
• the bending strength of the hard holder 22 was 82 mN/ m2 .
• the amplitude (sound pressure) of the ultrasound was 0.3 MPa at the target area, and the frequency of the ultrasound was 0.5 MHz.
• Unfocused ultrasound energy was irradiated alternately by the convex curved transducers 8A and 8B at intervals of 1.28/fms.
• the headset 20 was composed of a headband 21 that was attached circumferentially to the subject's head, and upper and lower fixing bands 25 that were attached in a roughly arched shape above the headband 21.
• the upper and lower fixing bands 25 were inclined 40° forward relative to the headband 21 in a side view.
• the headband part 21 consists of a hard holder 22, a forehead band 23, and an occipital band 24, and the bending strength of the forehead band 23, the occipital band 24, and the upper and lower fixing bands 25 was 1.5 mN/ m2 .
• the longitudinal width of the forehead band 23 was 210 mm.
• the length adjustment mechanism 230 provided on the forehead band 23 allowed the length to be adjusted according to the size of the subject's temporal bone, with an adjustment range of 80 mm.
• the circumference of the headband part 21, which was attached circumferentially around the subject's head, could be adjusted from 470 to 690 mm.

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• 2024
  • 2024-06-07 JP JP2025532444A patent/JPWO2025013486A1/ja active Pending
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