Ultrasonic therapeutic device

Abstract

The present invention provides an ultrasonic therapeutic device capable of easily and accurately fixing an ultrasonic vibrator to a temporal bone of a subject even when the size of the head varies by a subject. There are provided two convex curved surface vibrators 8A, 8B for irradiating non-focused ultrasonic energy in a reverse tapered shape gradually expanding in diameter in a radiation direction, and a head set 20. The head set 20 comprises a headband part 21 and an upper and lower fixing band 25. The headband part 21 comprises: a hard holder 22 having a circular arc shape in a plan view; a front head portion band 23 having a length adjustment mechanism 230 for adjusting the length of the headband part 21 according to the size of the temporal bone of the subject; and a rear head portion band 24 having a pressure adjustment mechanism 240 for adjusting the fastening pressure applied to the subject.

Description

Ultrasonic therapy device

[0001] The present invention relates to an ultrasonic treatment device for treating dementia and the like by irradiating ultrasonic waves.

[0002] Currently, the number of dementia patients in Japan is said to be as high as approximately 2.6 million, and is expected to increase in line with the rapid increase in the elderly population, exceeding 6.75 million by 2025. The number of dementia patients worldwide is estimated to be 35 million, with estimates predicting this number will reach 65 million by 2030 and 115 million by 2050. In terms of types of dementia, vascular dementia and Alzheimer's disease account for the majority of all cases, and many patients exhibit symptoms of both.

[0003] Measures to treat vascular dementia include drug treatment for hypertension, dyslipidemia, and diabetes, as well as reducing exercise, smoking, overeating, and stress, but no drugs have yet been developed to treat vascular dementia itself. Furthermore, for Alzheimer's disease, drugs that activate the acetylcholine pathway and inhibit glutamate are commercially available, but their therapeutic effects are not necessarily sufficient. Therefore, the development of effective means for treating dementia is desired.

[0004] The present inventors have previously confirmed that LIPUS (Low-Intensity Pulsed Ultrasound) improves angiogenesis and left ventricular function in ischemic porcine hearts (Non-Patent Document 1). LIPUS has recently attracted widespread attention in fields such as orthopedics, gastroenterology, neurology, and dentistry, and has already been clinically applied to the treatment of fractures. However, there have been no reports specifically examining the therapeutic effects of unfocused ultrasound energy irradiation on dementia.

[0005] 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 three-dimensionally to an irradiation position on a subject and fixing the same. However, although Patent Document 1 describes the structure of a headset worn on the head, it does not describe a headset that holds a convex curved transducer that irradiates ultrasound waves onto the temporal bone.

[0006] Patent Document 2 describes a device for treating dementia that uses a curved, convex-shaped transducer to irradiate the entire brain, and includes a plurality of ultrasound probes, ultrasound transducers arranged on the ultrasound probes and transmitting unfocused ultrasound energy to the brain, and an ultrasound generator connected to the ultrasound probes. However, 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.

[0007] Patent Literature 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 while the system is positioned on the subject's head, even without feedback from a clinician. However, the ultrasound transducer described in Patent Literature 3 is not convex, and the headset is simply worn on the bridge of the subject's nose in contact with the nasion.

[0008] 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, which is used for the prevention and treatment of brain diseases such as neurodegeneration. However, 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.

[0009] JP 2006-305047 A Patent No. 7184365 Patent No. 5748870 Patent No. 6670485

[0010] Hanawa K. Shimokawa H, et al. PLoS One.2014;9:e104863

[0011] The present invention has been made in consideration of such problems, and aims to provide an ultrasonic treatment device that can accurately fix an ultrasonic vibrator to the temporal bone of a subject (also called a patient) even when the head size varies depending on the subject or when the subject moves during measurement, and that can be easily attached without putting any strain on the subject.

[0012] The ultrasonic treatment device (100) according to the present invention is an ultrasonic treatment device (100) for irradiating ultrasonic waves to the brain of a subject, and comprises two convex curved transducers (8A, 8B) for irradiating the brain of the subject with unfocused ultrasonic energy in an inverse tapered shape that gradually expands in diameter 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, and the headset (20) comprises a headband part (21) that is attached circumferentially to the head of the subject, and a headband part (22) that is attached in a substantially arch shape above the headband part (21) and is attached to the head of the subject. and upper and lower fixing bands (25) that prevent the headband part (21) from shifting in the vertical direction and that have a curved shape to fit the subject's head, the headband part (21) being characterized by comprising: a hard holder (22) that is arc-shaped in a plan view and that fixes the convex curved vibrators (8A, 8B) to each of the left and right temporal parts of the subject; a forehead band (23) that has a length adjustment mechanism (230) that adjusts the length of the headband part (21) in accordance with the size of the subject's temporal bone; and an occipital band (24) that has a pressure adjustment mechanism (240) that adjusts the tightening pressure of the headband part (21) on the subject.

[0013] According to the present invention, even if the head size of each subject varies or the subject moves during measurement, the ultrasound transducer can be accurately fixed to the subject's temporal bone. Furthermore, the transducer can be easily attached without putting any strain on the subject.

[0014] 1 is a diagram illustrating the entire ultrasonic therapy device according to the present invention;

[0023] FIG. 1 is an external view of a headset attached to a subject's head, which is a characteristic feature of the invention;

[0024] FIG. 2 is an external view of a hard holder;

[0025] FIG. 3 is a diagram illustrating the external appearance before a convex curved vibrator is attached to a vibrator attachment section;

[0026] FIG. 4 is a diagram illustrating the left side of the headset from the side of the hard holder abutting the left temporal side of the subject's head and the convex curved vibrator housed in the hard holder;

[0027] FIG. 5 is a diagram illustrating the right side of the headset from the side of the hard holder abutting the right temporal side of the subject's head and the convex curved vibrator housed in the hard holder;

[0028] FIG. 6A is a diagram illustrating a length adjustment mechanism provided on the forehead band, showing a slidable state before being locked;

[0029] FIG. 6B is a diagram illustrating a length adjustment mechanism provided on the forehead band, showing a non-slidable state after being locked;

[0029] FIG. 7A is a diagram illustrating the state of connecting a first forehead band to a forehead band connection section, showing the state before connection. 1A is a diagram illustrating the state in which the first forehead band is connected to the forehead band connecting portion, and is a diagram illustrating the state after the connection. FIG. 1B is a diagram illustrating a pressure adjustment mechanism provided in the occipital band. FIG. 1C is an external view of the prototype headset 20.

[0015] Hereinafter, embodiments of the present invention will be described in detail with reference to the accompanying drawings. However, these embodiments are intended to facilitate understanding of the principles of the present invention, and the scope of the present invention is not limited to the following embodiments. Other embodiments in which a person skilled in the art appropriately replaces the configuration of the following embodiments are also included in the scope of the present invention.

[0016] The ultrasonic treatment device 100 according to the present invention is a treatment device that irradiates ultrasonic waves onto the brain of a subject.

[0017] As shown in FIG. 1, 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 vibration, and a headset 20 attached to the subject's head.

[0018] The ultrasound therapy device 100 transmits ultrasonic frequencies and irradiates the brain using LIPUS (Low-Intensity Pulsed Ultrasound), thereby enhancing the expression of eNOS (endothelial nitric oxide synthase) and VEGF, thereby treating, for example, dementia. Dementia includes vascular dementia, Alzheimer's disease, and symptoms that exhibit both. Dementia also encompasses symptoms such as mild cognitive impairment (MCI). In humans, eNOS (endothelial nitric oxide synthase) is encoded by the NOS3 gene, located in the 7q35-7q36 region of chromosome 7. This enzyme is one of three nitric oxide synthases that synthesize nitric oxide (NO).

[0019] 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 convex curved ultrasound irradiation surfaces, which allows the direction of ultrasound to be unfocused, thereby enabling irradiation of the entire target area. The transducers can be piezoelectric elements, PVDF, BaTi23, PIN-PmN-PT, or those using semiconductor processes such as CMUT and PMUT.

[0020] In the present invention, unfocused ultrasonic energy refers to ultrasonic energy that is diffused without being focused to a single point or a single 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°, more preferably 60° to 90°. Typically, ultrasonic energy is diffused in a substantially conical shape (the bottom portion can be curved).

[0021] The two convex curved transducers 8A and 8B are placed on the temporal region of the subject's head. By diffusing unfocused ultrasonic energy in an inverse tapered shape, it is possible to transmit ultrasonic energy to most of the brain, for example, a region including at least the hippocampus and corpus callosum, and typically to the entire brain.

[0022] 1, the system 10 comprises a device input unit for inputting a 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. As described above, the transmission unit 7 is connected to the convex spherical curved transducers 8A and 8B to supply energy for ultrasonic vibration.

[0023] Treatment information input by an operator 1, such as treatment area 2 and subject information 3, is transmitted to a transmission condition control unit 5 and a treatment protocol control unit 6 by a control unit 4, which serves as a protocol management system within the device, and transmission conditions and a treatment protocol are transmitted from a transmission unit 7. Based on these, unfocused ultrasonic energy is irradiated to the target area by convex curved transducers 8A and 8B. In this way, the frequency, time, timing, etc. of the vibration of convex curved transducers 8A and 8B are controlled by a system 10.

[0024] In the present invention, 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 proliferation, etc., through gentle ultrasound stimulation. On the other hand, in the present invention, the lower limit of the intensity of the irradiated ultrasound is not particularly limited, but from the viewpoint of therapeutic effectiveness, it is preferably, for example, 0.05 MPa or more, preferably 0.1 MPa or more. In the present invention, 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.

[0025] Furthermore, in the present invention, from the viewpoint of suppressing the transmission of excessive ultrasonic energy into the brain due to the overlapping transmission of ultrasonic energy radiated from the convex curved transducers 8A and 8B into the brain, it is preferable to control the ultrasonic transducers so that unfocused ultrasonic energy is sequentially radiated between the convex curved transducers 8A and 8B. Sequential irradiation of unfocused ultrasonic energy means that first, one of the convex curved transducers 8A and 8B generates ultrasonic waves, while the other does not generate ultrasonic waves during that time, then the other transducer generates ultrasonic waves, while the other does not generate ultrasonic waves during that time, etc., meaning that only one of the convex curved transducers 8A and 8B generates ultrasonic waves at the same time, in other words, that ultrasonic waves are not generated from two or more transducers at the same time.

[0026] In the present invention, ultrasonic waves generated from the convex curved transducers 8A and 8B pass through the skull, propagate to the brain, and are reflected by the skull on the opposite side before being propagated again. The reflected ultrasonic waves are then reflected again and propagated again. During this time, the ultrasonic waves are attenuated as they propagate through the brain and as they are reflected by the skull. In this way, the ultrasonic 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.

[0027] In the present invention, it is preferable that unfocused ultrasonic energy is irradiated by the convex curved transducers 8A and 8B at intervals of 0.15 / f (f indicates the frequency (MHz) of the transmitted pulse) ms or more, more preferably 0.3 fms or more.

[0028] Here, the interval of unfocused ultrasonic energy irradiation means, in the above sense, the time from the end of ultrasonic irradiation from one oscillator 8A to the start of ultrasonic irradiation from the next oscillator 8B when ultrasonic irradiation is started from a certain oscillator 8A, then stopped, and then ultrasonic irradiation is started from the next oscillator 8B, then stopped, and so on.

[0029] In the present invention, the irradiated ultrasonic waves are discontinuous waves, and the number of cycles is not particularly limited, but can be appropriately set within the range of, for example, 1 to 64 cycles, preferably 24 to 40 cycles. Here, 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 pulse width in this specification).

[0030] Figure 2 is an external view of a headset 20 attached to the head of a subject, which is a characteristic feature of the present invention. As shown in Figure 2, the headset 20 has a headband 21 attached circumferentially to the head of the subject, and upper and lower fixing bands 25 attached in a generally arched shape above the headband 21 and curved to fit along the head of the subject near the forehead. The upper and lower fixing bands 25 prevent the headband 21 from shifting in the vertical direction.

[0031] The upper and lower fixing bands 25 are preferably inclined forward by 30° to 60° relative to the headband part 21 in a side view.

[0032] As shown in Figure 2, the headband part 21 consists of a hard holder 22 that fixes the convex curved vibrators 8A, 8B to the left and right temporal parts 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 part of the subject's head.

[0033] 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.

[0034] In the present invention, the hard holder 22 is formed of a hard material such as a metal material in order to properly fix the convex curved vibrators 8A and 8B to the left and right temporal parts of the subject, while the forehead band 23, occipital band 24, and upper and lower fixing bands 25 are formed of a flexible material so that they can be flexibly attached to subjects of various physiques.

[0035] For example, the upper and lower fixing bands 25, the front head band 23, and the rear head band 24 all have a resistance of 0.1 N·m 2 More than 1.5N・m 2 It is preferable that the material be flexible and have the following bending stiffness.

[0036] 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 thereof.

[0037] Figure 3 is an external view of the hard holder 22. As shown in Figure 3, the hard holder 22 has an arc-shaped surface in a planar view. This arc-shaped surface provides a curved surface that can fit snugly against the subject's temporal region, with a desirable radius of curvature in the range of 90 mm to 300 mm. According to the database (https: / / www.airc.aist.go.jp / dhrt / head / index.html), the head circumference of elderly men and women is 499–618 mm within a 3σ range. If the head circumference were considered a circle, the radius of curvature would be 79–98 mm. However, because the area near the temporal bone is relatively flat, the radius of curvature is larger than that expected from the head circumference. Furthermore, if the holder were completely flat, a large gap would be created between the head and the head, causing the transducer to misalign.

[0038] Since the hard holder 22 is connected to the frontal band 23, the occipital band 24, and the upper and lower fixing bands 25, the hard holder 22 is provided with a frontal band connection part 223 which is the end that connects to the frontal 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.

[0039] The hard holder 22 is provided with a vibrator mounting portion 221 capable of housing the convex curved vibrator 8A. In the present invention, the material of the convex curved vibrator 8A is not particularly limited as long as it can generate the unfocused ultrasonic energy, and examples thereof include PZT (lead zirconate titanate) and PVDF (polyvinylidene fluoride).

[0040] Fig. 4 is a diagram showing the appearance of the convex curved vibrator 8A before it is attached to the vibrator attachment portion 221. As shown in Fig. 4, 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.), etc. The size of the convex curved vibrator 8A is not particularly limited, but for example, when the shape is approximately circular, the diameter is preferably 1.0 to 5.0 cm, and more preferably 2.0 to 4.0 cm.

[0041] To determine its position, 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 fix the convex curved vibrator. The holder has a shape that matches the shape for positioning the vibrator.

[0042] The shape of the vibrator mounting portion 221 is not particularly limited as long as it can accommodate the convex curved vibrator 8A without any gaps. When the shape of the convex curved vibrator 8A is approximately circular, the shape of the vibrator mounting portion 221 will also be a corresponding approximately circular cup shape.

[0043] Fig. 5 is a diagram showing the appearance of the convex curved transducer 8A after it has been attached to the transducer attachment portion 221. As shown in Fig. 5, the transducer attachment portion 221 tightly houses the convex curved transducer 8A, and the convex curved ultrasound irradiation surface of the convex curved transducer 8A is exposed from the transducer attachment portion 221. This allows unfocused ultrasound energy to be efficiently transmitted from the convex curved transducer 8A to the brain of the subject.

[0044] The convex curved surface vibrator 8A and the hard holder 22 may be attached permanently or semi-permanently with an adhesive, or may be attached with screws, a locking mechanism, or the like.

[0045] 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. As shown in Fig. 6, on the hard holder 22 (left side), 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, and a first upper and lower fixing band 251 is connected to the upper and lower fixing band connection part 225. The first upper and lower fixing band 251 is 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 fixing bands 25.

[0046] 7 is a diagram illustrating the right side of the headset 20 from the side of the hard holder 22 that abuts against the right temporal region of the subject and the convex curved vibrator 8B housed in the hard holder 22. As shown in FIG. 7, on the hard holder 22 (right side), a second frontal band 232 is connected to the frontal band connection part 223, a first occipital band 241 is connected to the occipital band connection part 224, and a second upper and lower fixing band 252 is connected to the upper and lower fixing band connection part 225.

[0047] The forehead band 23 consists of a first forehead band 231 provided on one hard holder 22 (left side) and a second forehead band 232 provided on the other hard holder 22 (right side).

[0048] The occipital band 24 is composed of a second occipital band 242 provided on one hard holder 22 (left side) and a first occipital band 241 provided on the other hard holder 22 (right side).

[0049] The upper and lower fixing bands 25 are made up of a first upper and lower fixing band 251 provided on one hard holder 22 (left side) and a second upper and lower fixing band 252 provided on the other hard holder 22 (right side).

[0050] Fig. 8(A) is a diagram illustrating the length adjustment mechanism 230 provided on the forehead band 23, showing the slidable state before it is locked. Fig. 8(B) is a diagram illustrating the length adjustment mechanism 230 provided on the forehead band 23, showing the non-slidable state after it is locked.

[0051] As shown in Figure 8(A), the distal end of the first forehead band 231 is provided with a plurality of engagement recesses 233 at regular intervals in the longitudinal direction. The distal end of the second forehead band 232 is provided with engagement protrusions 234 that can be detached from the engagement recesses 233. As shown in Figure 8(B), the engagement protrusions 234 are fitted into any position of the engagement recesses 233 to lock them in place, thereby fixing the band and adjusting its length. A 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.

[0052] The tip end of the first occipital band 241 is provided with a plurality of engagement recesses 243 spaced at regular intervals in the longitudinal direction. The tip end of the second occipital band 242 is provided with an engagement protrusion 244 that can be detached from the engagement recess 243. The length adjustment mechanism 246 adjusts the length by fitting and 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.

[0053] The distal end of the first upper and lower fixing band 251 is provided with a plurality of engagement recesses 253 at regular intervals in the longitudinal direction. The distal end of the second upper and lower fixing band 252 is provided with engagement protrusions 254 that can be attached to and detached from the engagement recesses 253. The length adjustment mechanism 250 adjusts the length by locking the engagement protrusions 254 into any position of the engagement recesses 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 lengths of the forehead band 23 and the occipital band 24 have been adjusted.

[0054] The range of adjustment can be defined as follows. According to the database (https: / / www.airc.aist.go.jp / dhrt / head / index.html), when the head circumference of elderly men and elderly women is calculated using 3σ, it is 525-618 mm and 499-593 mm, respectively. When making a unisex headband, an adjustment range of at least 100 mm is required.

[0055] Furthermore, based on the same data, the head width for elderly men and elderly women calculated at 3σ is 139-178 mm and 137-167 mm, respectively, which requires an adjustment range of at least 40 mm.

[0056] From the above, 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.

[0057] The upper and lower fixing bands 25 have an adjustment range of at least 40 mm, similar to the forehead band 23. Although no data from Europe or the United States is listed, it is thought that their heads are larger than those of Japanese people.

[0058] 9(A) is a diagram illustrating the state before connecting the first forehead band 231 to the forehead band connecting part 223. FIG. 9(B) is a diagram illustrating the state after connecting the first forehead band 231 to the forehead band connecting part 223.

[0059] As shown in Figure 9(A), 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 connecting portion 223. As shown in Figure 9(B), attachment is possible by physically pressing and fitting the fitting protrusion 238 into the fitting recess 239. Note that in addition to fixation by the physical fitting force between the fitting recess and fitting protrusion, screw fixation or adhesive fixation with a predetermined adhesive is also possible.

[0060] This attachment 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.

[0061] However, the occipital band connecting portion 224 and the first occipital band 241 are not connected using the aforementioned fitting projection and fitting recess.

[0062] Figure 10 is a diagram illustrating the pressure adjustment mechanism 240 provided on the occipital band 24. As shown in Figure 10, 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. Pressure adjustment rubbers 246 are 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.

[0063] The following describes a treatment method using the ultrasonic therapy device 100 of the present invention. The duration of ultrasonic treatment is not particularly limited, but can be set appropriately between 1 and 60 minutes per treatment, preferably between 15 and 25 minutes, depending on the patient's symptoms, ultrasonic intensity, etc. The number of treatments per day is also not particularly limited, but can be set appropriately between 1 and 4 times, preferably between 2 and 3 times. The frequency of treatment is also not particularly limited, but can be set appropriately between 1 and 7 times per week, preferably between 2 and 3 times per week. The treatment interval is also not particularly limited. For example, if one set of treatment is performed at the above frequency for 5 to 10 days (more preferably 6 to 8 days), it is preferable to perform the treatment continuously once every 1 to 4 months (e.g., once every 1 to 3.5 months), unless adverse events occur.

[0064] The ultrasonic intensity is I SPPA , I SPTA It can be adjusted by, etc. Here, I SPPA indicates the average intensity within the pulse width. SPTA indicates the average intensity within a repetition period.

[0065] In addition, the I SPTA The intensity is not particularly limited, but from the viewpoint of promoting angiogenesis, neuron proliferation, etc. by gentle ultrasonic stimulation, for example, 200 mW / cm 2 or less, preferably 10 to 150 mW / cm 2 It can be set appropriately within the range.

[0066] Furthermore, the patient may be in a chair during treatment, or may be lying down for separate treatment. The compact size of the device means it can be used during everyday activities, such as walking. In either case, the patient may move, so it is important to keep the device in place throughout the treatment.

[0067] As shown in Figure 11, a headset 20 was fabricated. 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 / m.2 It was.

[0068] The ultrasonic amplitude (sound pressure) was 0.3 MPa at the target area, and the frequency of the ultrasonic waves was 0.5 MHz. Unfocused ultrasonic energy irradiation by the convex curved transducers 8A and 8B was alternately performed at intervals of 1.28 / fms.

[0069] The headset 20 was configured to have a headband 21 that was attached circumferentially around the subject's head, and upper and lower fixing bands 25 that were attached in a generally arched shape above the headband 21. The upper and lower fixing bands 25 were inclined forward by 40° relative to the headband 21 in a side view.

[0070] The headband 21 is made up of a hard holder 22, a front head band 23, and an occipital band 24. The bending strength of the front head band 23, the occipital band 24, and the upper and lower fixing bands 25 is 1.5 mN / m. 2 It was.

[0071] The longitudinal width of the forehead band 23 was 210 mm. The length adjustment mechanism 230 provided on the forehead band 23 allowed for length adjustment according to the size of the subject's temporal bone, with an adjustment range of 80 mm. The circumference of the headband 21, which was attached circumferentially around the subject's head, could be adjusted from 470 to 690 mm.

[0072] It can be used to treat dementia.

[0073] 1: Operator 2: Treatment area 3: Subject information 4: Control unit 5: Transmission condition control unit 6: Treatment protocol control unit 7: Transmitter 8A, 8B: Convex curved transducer 9: Display 10: System 20: Headset 21: Headband 22: Hard holder 23: Forehead band 24: Occipital band 25: Upper and lower fixing bands 100: Ultrasonic treatment device 221: Transducer attachment unit 223: Forehead band connection unit 224: Occipital band connection unit 225: Upper and lower fixing band connection unit 230: Length adjustment mechanism 231: First forehead band 232: Second forehead band 240: Pressure adjustment mechanism 246: Length adjustment mechanism 241: First occipital band 242: Second occipital band 251: First upper and lower fixing band 252: Second upper and lower fixing band

Claims

1. An ultrasonic treatment device (100) for irradiating ultrasonic waves to the brain of a subject, comprising: two convex curved transducers (8A, 8B) for irradiating the brain of the subject with unfocused ultrasonic energy in an inverse tapered shape that gradually expands in the direction of radiation; a transmission unit (7) connected to the convex curved transducers (8A, 8B) for supplying energy for ultrasonic vibration; and a headset (20) attached to the head of the subject, the headset (20) comprising a headband part (21) attached circumferentially to the head of the subject, and upper and lower fixing bands (25) attached in a generally arched shape above the headband part (21) and having a curved shape to fit the head of the subject, for preventing the headband part (21) from shifting in the vertical direction, the headband part (21) comprising: An ultrasonic therapeutic device (100) comprising: a hard holder (22) having an arc-shaped planar view for fixing the convex spherical transducers (8A, 8B) to the left and right temporal parts of the subject; a forehead band (23) having a length adjustment mechanism (230) for adjusting the length of the headband portion (21) in accordance with the size of the subject's temporal bone; and an occipital band (24) having a pressure adjustment mechanism (240) for adjusting the tightening pressure of the headband portion (21) on the subject.

2. The ultrasonic treatment device (100) according to claim 1, characterized in that the upper and lower fixing bands (25) are inclined forward by 30° to 60° relative to the headband portion (21) in a side view.

3. The upper and lower fixing bands (25), the front head band (23), and the rear head band (24) each have a tension of 0.1 N·m 2 More than 1.5N・m 2 3. The ultrasonic treatment device (100) according to claim 2, characterized in that it is made of a flexible material having a bending rigidity less than that of the hard holder (21A) and is more flexible than the hard holder (21A).

4. The ultrasonic treatment device (100) according to claim 3, characterized in that the flexible material is polyethylene, polypropylene, polystyrene, acrylonitrile-styrene resin, acrylonitrile-butadiene-styrene resin, polyvinyl chloride, methacrylic resin, polyethylene terephthalate resin, polyurethane, polycarbonate, or other resin, silicone, natural rubber, or a composite resin thereof.

5. The ultrasonic therapeutic device (100) according to claim 1, characterized in that the forehead band (23) comprises a first forehead band (231) provided on one hard holder (22) and a second forehead band (232) provided on the other hard holder (22), the tip end of the first forehead band (231) is provided with a plurality of engagement recesses (233) at regular intervals in the longitudinal direction, the tip end of the second forehead band (232) is provided with an engagement protrusion (234) that can be detached from the engagement recess (233), and the length adjustment mechanism (230) is length adjusted by fitting the engagement protrusion (234) into any position of the engagement recess (233) and locking it.

6. The ultrasonic therapeutic device (100) according to claim 1, characterized in that the upper and lower fixing bands (25) are composed of a first upper and lower fixing band (251) provided on one of the hard holders (22) and a second upper and lower fixing band (252) provided on the other hard holder (22), the tip end of the first upper and lower fixing band (251) is provided with a plurality of engagement recesses (253) at regular intervals in the longitudinal direction, and the tip end of the second upper and lower fixing band (252) is provided with an engagement protrusion (254) that can be detached from the engagement recesses (253), and the length adjustment mechanism (250) is length adjusted by fitting and locking the engagement protrusion (254) into any position of the engagement recess (253).

7. The ultrasonic therapeutic device (100) according to claim 1, characterized in that the occipital band (24) comprises a first occipital band (241) provided on one hard holder (22) and a second occipital band (242) provided on the other hard holder (22), the tip end of the first occipital band (241) is provided with a plurality of engagement recesses (243) at regular intervals in the longitudinal direction, the tip end of the second occipital band (242) is provided with an engagement protrusion (244) that can be detached from the engagement recess (243), and the length adjustment mechanism (246) is characterized in that the engagement protrusion (244) is fitted into any position of the engagement recess (243) and locked, thereby adjusting the length.

8. The ultrasonic therapeutic device (100) of claim 1, characterized in that the pressure adjustment mechanism (240) of the occipital band (24) comprises a pressure adjustment rubber hook portion (247) provided on the first occipital band (241), a pressure adjustment rubber hook portion (247) provided on the occipital band connection portion (224) of the hard holder (22), and a pressure adjustment rubber (246) hooked between the pressure adjustment rubber hook portions (247), and the pressure is adjusted by the elastic tension of the pressure adjustment rubber (246).

9. The ultrasonic therapy device (100) of claim 1, wherein the angle of the inclined surface of the expanding inverse tapered unfocused ultrasonic energy is between 50° and 100°.

Images