Movable ultrasonic stimulation headgear for sleep

Abstract

The present invention comprises: an ultrasonic wave generation device for generating a pulse bundle, which has a low intensity of intensity spatial peak pulse average (ISPPA) 50 W / cm2 or less and which is composed of pulses of a first frequency through ultrasonic waves, and forming, through the pulse bundle, a second frequency and outputting same; a transducer which is connected to the ultrasonic wave generation device, and which irradiates the brain of a mammal with ultrasonic waves so as to stimulate the frontal lobe area of the brain with the ultrasonic waves; and a head frame on which the transducer is mounted and which can be worn on the head of the mammal, wherein the transducer is mounted on the head frame such that the position and angle formed with the head through a rail structure and a hinge structure provided on the head frame can be adjusted, so as to selectively adjust the frontal lobe stimulation position of the brain stimulated by irradiation of the ultrasonic waves while moving along the head, and thus customized ultrasonic wave irradiation is performed in correspondence to a body region of a user requiring ultrasonic wave irradiation.

Description

Portable ultrasound stimulation headgear for sleep

[0001] The present invention relates to an ultrasonic stimulation headgear, and more particularly, to a mobile ultrasonic stimulation headgear for sleep in which an ultrasonic stimulator is mounted on the headgear so as to be able to adjust the position and angle it forms with respect to the head using a rail structure and a hinge structure provided on the headgear, and moves along the head, and a stimulation position of the frontal lobe of the brain stimulated by the ultrasonic irradiation is selectively adjusted, thereby providing customized ultrasonic irradiation corresponding to an area of ​​the user's body that requires the ultrasonic irradiation.

[0002] Sleep is an essential physiological phenomenon that accounts for one-third of human lifespan and is a very important factor in maintaining health and mental stability. Chronic sleep deprivation and sleep disorders are reported to have a negative impact on overall physical and mental health, including cardiovascular disease, high blood pressure, memory and learning, metabolic regulation and weight, immunity and cancer resistance, diabetes, safety accidents, and mood.

[0003] In modern society, due to industrialization, lights are always on throughout the city even at night, and social diversity such as night work, shift work, and intercontinental time zone travel has led to changes in the circadian rhythm of sleep-wake and a rapid increase in sleep disorders such as insomnia.

[0004] Approximately 30% of the world's population experiences insomnia, and 10% suffer from it chronically, indicating that sleep disorders are a significant problem. In Korea, medical expenses for sleep disorders are also increasing, requiring special management.

[0005] According to a press release from the National Health Insurance Service [September 19, 2019], the total number of patients with sleep disorders increased by an annual average of 1% from 415,502 in 2014 to 568,067 in 2018, and there were 1.4 times more female patients than male patients (Table 1). When looking at the number of patients by age group, the number of patients increased with increasing age, but the number of patients aged 70 and older was overwhelmingly higher than other age groups, and the rate of increase was particularly high in both men and women in their 60s and men in their 20s.

[0006] [Table 1] - Sleep Disorder Treatment Status by Year (Source: National Health Insurance Service Press Release)

[0007]

[0008] In particular, the number of patients visiting nursing facilities due to insomnia, a sleep disorder, has been steadily increasing every year, increasing by 3% (138,541) from 403,417 in 2012 to 541,958 in 2016, and looking at the number of patients per 100,000 people, 1,068 people, or 1 in 100, visited nursing facilities due to insomnia in 2016.

[0009] Insomnia is a symptom of not being able to sleep. It refers to cases where symptoms of difficulty falling asleep persist for at least one month or where the patient wakes up frequently more than three times a week, and where the patient complains of being very tired during the day due to lack of sleep.

[0010] There are various causes of insomnia, including the increase in the obese population, rapid environmental changes, increased stress, changes in sleeping habits due to excessive work in modern times, and poor sleep habits (habits that should be maintained for a good night's sleep). It can also be caused by changes in sleep structure due to the normal aging process.

[0011] Additionally, there are secondary causes such as accompanying internal or psychiatric diseases, neurodegenerative or neurological diseases, drug-induced diseases, alcohol consumption, or sleeping pill abuse.

[0012] In particular, as we age, various physiological changes occur, such as changes in brain metabolism and structure, which cause sleep fragmentation and frequent awakenings, changes in circadian rhythms, and changes in the autonomic nervous system and hormones, which increase sleep disorders in the elderly.

[0013] Mild insomnia can be caused by excessive caffeine intake, such as coffee or tea, or by medications such as stimulants or vitamins. Insomnia can also be triggered by environmental changes or stress. Chronic insomnia is often caused by cerebrovascular disorders, autonomic nervous system and endocrine disorders, asthma, heart disease, lung disease, physical pain such as headaches, and mental illness. While medication can be used to treat mild insomnia, using medication for these symptoms can lead to drug dependence.

[0014] Meanwhile, in relation to the possibility of improving sleep and enhancing cognition through neuromodulation of the sleep-wake brain circuit, if the sleep-wake circadian rhythm is disrupted, it can lead to not only insomnia but also sleep deprivation and daytime sleepiness, and a vicious cycle in which work-related / environmental / psychological stress further aggravates sleep problems is repeated, limiting the ability to exert maximum cognitive ability and hindering learning and brain function development, especially in school-age adolescents.

[0015] Because sleep disorders are associated with functional brain problems, it is necessary to develop brain science-based sleep disorder control technologies. This requires understanding the role of key brain circuits related to sleep disorders through research on sleep improvement mechanisms. By understanding the brain circuit-based developmental mechanisms underlying sleep-wake and sleep stage regulation, and by studying the causal relationships between key brain regions, we can develop new concepts for sleep-wake regulation and sleep improvement, develop treatments for sleep disorders, and develop medications for insomnia.

[0016] The brain circuits related to sleep and wakefulness regulation are mainly deep brain regions such as the thalamus, basal forebrain, and brainstem, and the prefrontal cortex, amygdala, cingulate gyrus, and hippocampus of the limbic system, which are related to stress, emotion, and cognition, and the cerebral cortex and subcortical brain regions are closely connected structurally and functionally.

[0017] Research is being conducted on the default mode network (DMN), a brain circuit in the resting state of the brain that regulates sleep and wakefulness. The best-known default mode network is a network that includes the medial prefrontal cortex (mPFC), precuneus, and posterior cingulate cortex. This network is activated when the brain is in a resting state in a conscious state without sleep, and its activation is suppressed when the brain enters a sleep state. Excessive DMN activation has been reported in cases of psychiatric disorders that interfere with sleep, such as insomnia or depression.

[0018] Among the brain regions involved in the DMN, the mPFC in particular is known to play a key role in emotional regulation through the amygdala and memory regulation through the hippocampus. Research has shown that metabolic activity in the mPFC region is reduced in insomnia patients. The mPFC is closely related to the generation of slow wave activity that occurs during sleep, which is known to promote the formation of long-term memory. It is also known that damage to the mPFC reduces slow wave sleep. Therefore, it is expected that research on the regulation of sleep and sleep-related cognitive functions through the regulation of mPFC activity will be possible.

[0019] Next, with regard to the validity of applying low-intensity focused ultrasound (LIFU) to the sleep disorder intervention effect, the target brain region of most of the existing non-invasive neuromodulation clinical trials for sleep and emotion regulation was the dorsolateral prefrontal region of the cerebral cortex, and this was because methods such as rTMS and tDCS, which are difficult to stimulate in the deep and medial brain regions, were used.

[0020] The mPFC region, one of the core brain circuits of sleep-wake, is an area that is difficult to stimulate noninvasively using existing brain stimulation techniques. Unlike existing brain stimulation techniques, low-intensity focused ultrasound has the advantage of being able to stimulate deep into the brain, making it possible to study the stimulation effect of the mPFC, which is located deep in the brain and has been difficult to study in the past.

[0021] The U.S. FDA has approved ultrasound stimulation for Parkinson's disease and associated tremor symptoms, and clinical trials of low-intensity focused ultrasound are underway for depression, obsessive-compulsive disorder, dementia, etc. Since the brain neuromodulation effect of low-intensity focused ultrasound has been sufficiently proven, it seems feasible to apply it to the regulation of brain function by setting a brain target area related to sleep function by taking advantage of the high location resolution and deep stimulation of the target area to be stimulated.

[0022] Next, with regard to the importance of developing a clinical research protocol for neuromodulation technology to improve sleep and enhance brain function, noninvasive brain stimulation, especially repetitive transcranial direct current / alternating current electrical and magnetic stimulation, has already been approved by the FDA in the United States in 2007 for the treatment of drug-refractory mild depressive disorder, and in Korea, it was also approved by the Ministry of Food and Drug Safety in 2014 for the treatment of depression and is being used.

[0023] Recently, a small number of researchers have published results on the treatment of sleep disorders using transcranial direct current / alternating current electrical stimulation and sleep stage-specific white noise stimulation devices. However, there is little research on the core brain circuits of sleep disorders that cause emotional / cognitive brain dysfunction and the brain circuits related to the improvement of sleep disorders and emotional / cognitive brain dysfunction through noninvasive stimulation.

[0024] Therefore, this is a human application study of neuromodulation treatment targeting key human brain circuits related to sleep improvement through noninvasive local brain stimulation, and it is essential to expand its application not only to the general population but also to patients with various sleep disorders to establish a clinical research protocol and sleep improvement service.

[0025] This study will precisely analyze changes in brain networks according to stimulation conditions of the medial prefrontal cortex during noninvasive low-intensity focused ultrasound neuromodulation targeting the mPFC among brain science-based sleep-wake-related brain circuits, and will be able to establish appropriate stimulation parameters for improving sleep and regulating brain regions of sleep-wake using this neuromodulation stimulation.

[0026] Lastly, regarding the definition, explanation, working principle, and treatment status of low-intensity focused ultrasound, ultrasound is a sound wave with a frequency higher than the audible frequency (16 Hz to 20 kHz), and is widely used in existing clinical settings, such as in ultrasonic medical imaging devices, high-intensity focused ultrasound surgical devices, and ultrasonic tumor treatment devices.

[0027] The ultrasound stimulus to be used is a pressure-sound wave type. Unlike the high-frequency ultrasound used in existing diagnostic ultrasound devices, it is delivered at a frequency of less than 500 kHz, enabling it to penetrate the skull and focus deep into the brain. Furthermore, the size affected by the ultrasound (the focal area) is at least 5-6 mm in size, an elliptical cone (shaped like a grain of rice), enabling precise functional control of specific areas.

[0028] The principal investigator and his collaborating research team demonstrated through various animal tests that focused ultrasound can regulate the excitability of brain tissue, and in human tests, they successfully stimulated the somatosensory cortex and visual cortex of the brain and quantified this through electrophysiology and functional MRI.

[0029] Devices that generate focused ultrasound waves were invented by scientists in the United States and the Soviet Union in the 1950s and 1960s. They can convert electrical waveforms into mechanical waveforms using piezoelectric materials, and when the piezoelectric materials are operated in a degassed medium (e.g., degassed water), they can convert them into ultrasonic pressure shock waves with a frequency of 20 kHz or higher. These shock waves are generated in the piezoelectric materials arranged in a hemispherical shape and are focused around a location corresponding to the Radius of Curvature (ROC) of the hemispherical circumference.

[0030] Currently, clinical trials using low-intensity focused ultrasound (LIFUS) are underway worldwide for the treatment of dementia, stroke, Parkinson's disease, and other emotional disorders through brain stimulation. A research team at Tohoku University in Japan was the first in the world to initiate a clinical trial using ultrasound to treat dementia, and a Korean team has also received approval for a clinical trial using focused ultrasound to open the blood-brain barrier in Alzheimer's disease patients. Furthermore, an Italian research team announced research results demonstrating that stimulating the thalamus with focused ultrasound can alleviate tremors and tremor associated with Parkinson's disease. In Korea, animal experiments have shown for the first time that stimulating the cerebellum with ultrasound can compensate for brain damage caused by stroke and treat motor disorders caused by hemiplegia.

[0031] Based on the backgrounds described above, the existing ultrasound device using a non-invasive focused ultrasound irradiation method using an ultrasound stimulator (21) that has been proposed in the past has a fixed structure in which the position of the ultrasound stimulator (21) is fixed and used on a structure (20) worn on the head (10) such as a headgear, a headband, a hat, a helmet, etc., as shown in FIG. 1. Therefore, in a situation where a plurality of ultrasound stimulators (21) must be placed over the entire area of ​​the device in order to stimulate various areas of the brain with an ultrasound stimulation system, it is difficult to freely adjust the brain stimulation position for each treatment stage, and the placement method is complicated, so it is somewhat inappropriate for use for sleep in particular because it is structurally inconvenient, and there is a problem that a lot of cost is incurred in manufacturing and operating it.

[0032] Accordingly, the present invention has been devised to solve the above problems, and the purpose of the present invention is to provide a mobile ultrasound stimulation headgear for sleep in which an ultrasound stimulator is mounted on a headgear so as to be able to adjust the position and angle it forms with respect to the head using a rail structure and a hinge structure provided on the headgear, and moves along the head, thereby selectively adjusting the stimulation location of the frontal lobe of the brain stimulated by ultrasound irradiation, thereby enabling customized ultrasound irradiation to be performed in response to an area of ​​the user's body that requires ultrasound irradiation.

[0033] However, the technical problems to be achieved in the present invention are not limited to the technical problems mentioned above, and other technical problems not mentioned can be clearly understood by a person having ordinary skill in the technical field to which the present invention belongs from the description below.

[0034] According to one embodiment of the present invention, which is a technical means for achieving the above object, a mobile ultrasound stimulation headgear for sleep comprises: an ultrasound generator having a low intensity of ISPPA (Intensity Spatial Peak Pulse Average) of 50 W / cm2 or less, generating a pulse bundle consisting of pulses of a first frequency using ultrasound, and forming and outputting a second frequency using the pulse bundle; a transducer connected to the ultrasound generator and irradiating ultrasound toward the brain of a mammal to cause ultrasound stimulation in the frontal lobe region of the brain; and a head frame on which the transducer is mounted and which is wearable on the head of the mammal, wherein the transducer is mounted on the head frame so as to be able to adjust a position and an angle formed with respect to the head through a rail structure and a hinge structure provided on the head frame, so that the transducer can move along the head, and a stimulation position of the frontal lobe of the brain stimulated by the irradiation of the ultrasound can be selectively adjusted.

[0035] In addition, the head frame may include a first semicircular support portion having a curvature along the head circumference of the mammal and forming a front region with respect to the head when worn on the head; a second support portion connected to the first support portion and forming a rear region with respect to the head when worn on the head; a first position adjustment portion provided in a rail structure on the front portion of the first support portion to slide the transducer to the left and right sides of the head while changing the position of the transducer with respect to the head; and a second position adjustment portion interposed between the position adjustment portion and the transducer so as to support the transducer while being hinge-structured and connected to the first position adjustment portion, and changing the angle that the transducer forms with respect to the head while tilting the transducer, and moving the transducer to at least one of the upper, lower, left, and right sides of the head while rotating the transducer with respect to the connection point with the first position adjustment portion to individually change the position of the transducer with the first position adjustment portion.

[0036] In addition, the second support portion may be formed of a first band portion and a second band portion, each including a hair band made of an elastic material having elasticity and branching from an end portion of the first support portion, and the first and second band portions may be hinge-joined with the first support portion along the same axis to move the transducer to the front and rear sides of the head.

[0037] In addition, the first position adjustment unit may include a guide groove formed on the front side of the first support unit to extend to an arbitrary length toward the left and right sides of the head; an elastic body provided in the guide groove; a guide rail having a predetermined uneven pattern formed along the guide groove and coupled to the elastic body; and a guider having one side inserted into the guide groove and coupled to the guide rail while being in contact with the elastic body, and sliding along the guide rail while being pressed by the elastic body, and having a ball-shaped first coupling groove formed on the other side.

[0038] In addition, the above-mentioned pattern may be formed to have a resolution of 3 to 4 degrees for the movement angle of the transducer per step and 5 to 10 mm for the straight-line distance, and may have a cross-sectional shape in the form of a mountain in which straight and curved sections are harmoniously repeated, thereby reducing the distance between contact points for the transducer compared to a circular pattern.

[0039] In addition, the second position adjustment unit may include a first torque ball hinge that is movably coupled when a preset pressure is applied corresponding to the first coupling groove of the first position adjustment unit; a joint hinge unit having a joint structure in which one end is coupled to the first torque ball hinge and is extended to have an arbitrary length, and the extended length is divided into two and tilted when a preset pressure is applied; a second torque ball hinge that is formed in the same shape as the first torque ball hinge and is coupled to the other end of the joint hinge unit; and a bracket having a second coupling groove formed on one end that is movably coupled when a preset pressure is applied corresponding to the second torque ball hinge, and a mounting unit formed on the other end that supports and presses the transducer.

[0040] In addition, the mounting portion is formed with an inner diameter smaller than the outer diameter of the transducer to support the transducer with a preset tension when the transducer is mounted, and has a structure whose shape covers a radius greater than that of the transducer, and a portion thereof is made of a silicone material to prevent the transducer from being detached due to slipping.

[0041] Additionally, the low intensity may be ISPPA 25 W / cm2 or less, the first frequency may be 10 to 10,000 Hz, and the second frequency may be 1.4 to 10 Hz or less.

[0042] Additionally, the output signal of the transducer may be the current and voltage of the transducer.

[0043] Additionally, the ultrasonic generator may be capable of operating in a range of 60 seconds to 3,600 seconds, and the transducer may be configured such that 90% of the focused energy forms a focus of 10 mm or less at a distance of 10 to 40 mm from the surface of the transducer.

[0044] The mobile ultrasound stimulation headgear for sleep according to the present invention has a configuration in which a transducer is mounted on a head frame so as to be able to adjust the position and angle it forms with respect to the head using a rail structure and a hinge structure provided on the head frame, and moves along the head, thereby selectively adjusting the stimulation position of the frontal lobe of the brain stimulated by ultrasound irradiation, thereby having the effect of enabling customized ultrasound irradiation to be performed in response to the body area of ​​the user that requires ultrasound irradiation.

[0045] However, the effects that can be obtained from the present invention are not limited to the effects mentioned above, and other effects that are not mentioned can be clearly understood by a person having ordinary skill in the technical field to which the present invention belongs from the description below.

[0046] The following drawings attached to this specification illustrate preferred embodiments of the present invention, and together with the detailed description of the invention described below, serve to further understand the technical idea of ​​the present invention, and therefore, the present invention should not be interpreted as being limited to matters described in such drawings.

[0047] Figure 1 is a drawing showing an example of wearing an ultrasonic device according to the prior art.

[0048] Figure 2 is an image showing an MRI image of the ultrasound generator and transducer of the mobile ultrasound stimulation headgear for sleep according to the present invention.

[0049] Figure 3 is a 3D modeling image showing the overall external configuration of the ultrasonic stimulation headgear according to the present invention.

[0050] Figure 4 is a waveform diagram showing an example of parameter settings for ultrasonic waves used in the ultrasonic stimulation headgear according to the present invention.

[0051] Figure 5 is a 3D modeling image exemplifying an example of wearing the ultrasonic stimulation headgear according to the present invention.

[0052] Figure 6 is a 3D modeling image showing the configuration of the first position adjustment part in the ultrasonic stimulation headgear according to the present invention.

[0053] Fig. 7 is a 3D modeling image showing the overall cross-section and guide of the first position adjustment unit according to Fig. 6;

[0054] Fig. 8 is a 3D modeling image showing the guide rail of the first position adjustment unit according to Fig. 6;

[0055] Fig. 9 is a schematic diagram showing the uneven pattern of the guide rail according to Fig. 8.

[0056] Hereinafter, embodiments of the present invention will be described in detail with reference to the attached drawings so that those skilled in the art can easily practice the present invention. However, the description of the present invention is merely an embodiment for structural and functional explanation, and therefore the scope of the present invention should not be construed as being limited by the embodiments described in the text. That is, since the embodiments can be modified in various ways and can have various forms, the scope of the present invention should be understood to include equivalents that can realize the technical idea. In addition, the purposes or effects presented in the present invention do not mean that a specific embodiment must include all of them or only such effects, and therefore the scope of the present invention should not be construed as being limited thereby.

[0057] The meanings of terms described in the present invention should be understood as follows.

[0058] Terms such as "first" and "second" are intended to distinguish one component from another, and the scope of the rights should not be limited by these terms. For example, a first component could be referred to as a second component, and similarly, a second component could also be referred to as a first component. When a component is referred to as being "connected" to another component, it should be understood that it may be directly connected to that other component, but there may also be other components in between. Conversely, when a component is referred to as being "directly connected" to another component, it should be understood that there are no other components in between. Meanwhile, other expressions describing the relationship between components, such as "between" and "immediately between" or "adjacent to" and "directly adjacent to", should be interpreted similarly.

[0059] Singular expressions should be understood to include plural expressions unless the context clearly indicates otherwise, and terms such as "comprises" or "has" should be understood to specify the presence of stated features, numbers, steps, operations, components, parts, or combinations thereof, but not to exclude the possibility of the presence or addition of one or more other features, numbers, steps, operations, components, parts, or combinations thereof.

[0060] Unless otherwise defined, all terms used herein have the same meaning as commonly understood by those of ordinary skill in the art to which this invention pertains. Terms defined in commonly used dictionaries should be interpreted to be consistent with their meaning within the context of the relevant technology, and should not be interpreted as having ideal or overly formal meanings unless explicitly defined herein.

[0061] Hereinafter, the configuration of a preferred embodiment will be described in detail with reference to the attached drawings. Fig. 2 is an image showing an MRI image in which an ultrasonic generator (120) and a transducer (130) of a mobile ultrasonic stimulation headgear (100) for sleep according to the present invention operate. As illustrated in Fig. 2, the ultrasonic generator (120) is connected to the transducer (130), and the transducer (130) performs its function by irradiating ultrasonic waves (30) toward the brain of a therapist (administrator). The image may be an MRI (Magnetic Resonance Imaging) image, a CT (Computed Tomography) image, or the like.

[0062] A dedicated program (simulation program) on the computer simulates and displays the intensity of ultrasound (30) based on the voltage and current signals of the transducer (130). The ultrasound (30) irradiated into the brain is displayed as the ultrasound range of the transducer (130). In the simulation, the ultrasound (30) is displayed as a cone or a rectangle, and the inside of the rectangle changes in color from red to blue depending on the intensity. For example, the length and direction of the cone-shaped ultrasound (30) indicate the limit and direction of the ultrasound (30), and the red inside may indicate the location where the ultrasound intensity is the strongest, and the blue may indicate the location where the ultrasound intensity is the lowest. Therefore, the therapist can manipulate the transducer (130) while viewing the simulation results (feedback effect).

[0063] The ultrasonic generator (120) generates focused ultrasonic waves. The ultrasonic generator (120) can convert an electrical waveform into a mechanical waveform by using a piezoelectric material, and when the piezoelectric material is operated in a medium from which gas has been removed (e.g., degassed water), it can convert it into an ultrasonic pressure shock wave of 20 kHz or more. This shock wave is generated from the piezoelectric material arranged in a hemispherical shape and is focused at a position corresponding to the radius of curvature (ROC) of the hemispherical cylinder. The intensity of the ultrasonic wave (30) uses a low intensity of 50 W / cm2 or less, and according to the standards of the Ministry of Food and Drug Safety (hereinafter referred to as the Ministry of Food and Drug Safety), the ultrasonic wave (30) applies an effective intensity of 25 W / cm2 or less, and can be used within a range in which no heat or cavitation phenomenon occurs.

[0064] The ultrasound stimulus to be used is a pressure sound wave type, and rather than the high-frequency ultrasound used in existing diagnostic ultrasound machines, it is provided at a low-frequency band of 240 to 260 kHz (preferably 250 kHz), which can penetrate the skull and position the focus deep into the brain.

[0065] The size (focal area) affected by the ultrasound (30) is such that 90% of the focused energy forms a focus of less than 10 mm (preferably 3 to 7 mm, more preferably 5 to 6 mm) at a distance of 10 to 40 mm (preferably 30 mm) from the surface of the transducer (130). Since this focal area is a sphere or an elliptical cone (rice grain shape), detailed function control of a specific area is possible. In addition, it can be used within a range that does not exceed a mechanical safety index (Mechanical Index) of 1.9. In addition, the depth can be selected in the range of 40 to 70 mm depending on the disease.

[0066] Fig. 4 is a waveform diagram showing an example of parameter settings for ultrasonic waves (30) used in the ultrasonic stimulation headgear (100) of the present invention. As illustrated in Fig. 4, a pulse (150) is formed using an ultrasonic wave of 250 kHz. The frequency of the pulse (150) is 10 to 10,000 Hz. To this end, the duration (TBD) of the pulse (150) is 0.1 to 100 ms, and the duty cycle can be adjusted in the range of 1 to 100%.

[0067] The pulse bundle (140) is composed of regular pulses (150), and the frequency of the pulse bundle (140) is 1.4 to 10 Hz. To this end, the width (SD) of the pulse bundle (sonic wave treatment, 150) is set to 10 to 3,000 ms. In addition, the period (SI) of the pulse bundle (sonic wave treatment, 150) is set to 10 to 7,000 ms.

[0068] Additionally, the total ultrasound time (T / T) can be appropriately selected within the range of 60 to 3,600 seconds. If it is less than 60 seconds, the stimulation effect is minimal, and if it exceeds 3,600 seconds, excessive stimulation may cause excitement or side effects.

[0069] The transducer (130) can irradiate ultrasound (30) toward various areas of the therapist's body, and the control unit (not shown) can set various combinations of ultrasound waveforms so that stimulation of various pulse combinations is applied to the therapist's body areas.

[0070] For example, the transducer (130) can be fixed to the head (10) of the therapist by wearing the head frame (110), and as shown in FIG. 5, in order to selectively adjust the stimulation location of the frontal lobe by irradiation with ultrasound (30), the transducer (130) can be mounted on the head frame (110) so as to be able to adjust the position and angle formed with respect to the head (10) through a rail structure and a hinge structure provided on the head frame (110) and move along the head (10).

[0071] The head frame (110) may be configured to include a first support member (111), a second support member (112), a first position adjustment member (113), and a second position adjustment member (114) to movably mount the transducer (130).

[0072] The first support member (111) has a curvature along the circumference of the wearer's head and, when worn on the head (10), is preferably a semicircular frame forming a front area based on the head (10).

[0073] When the second support part (112) is connected to the first support part (111) and worn on the head (10), it is preferable to form a rear region based on the head (10).

[0074] Here, the second support part (112) may be formed of a first band part (112a) and a second band part (112b) each including a hair band made of an elastic material having elasticity and branching from the end of the first support part (111), and the first and second band parts (112a, 112b) are hinge-joined with the first support part (111) along the same axis to perform the function of moving the transducer (130) to the front and rear sides of the head (10).

[0075] The first position adjustment unit (113) is provided in the form of a rail structure on the front side of the first support member (111) with reference to FIGS. 6 and 7, and is configured to change the position of the transducer (130) with respect to the head (10) while sliding the transducer (130) to the left and right sides of the head (10), and includes a guide groove (113a) formed to extend to an arbitrary length toward the left and right sides of the head (10) on the front side of the first support member (111), an elastic body (113b) provided in the guide groove (113a), a guide rail (113c) having a predetermined uneven pattern (1131c) along the guide groove (113a) and coupled to the elastic body (113b), and one side of which is inserted into the guide groove (113a) and connected to the elastic body (113b) and coupled to the guide rail (113c), and by the elastic body (113b). It can be configured to include a guider (113d) that slides along a guide rail (113c) while being pressurized, and has a ball-shaped first coupling groove (1131d) formed on the other side.

[0076] At this time, the uneven pattern (1131c) is preferably formed to have a resolution of 3 to 4 degrees for the movement angle of the transducer (130) per step and 5 to 10 mm for the straight-line distance according to the present invention (see FIG. 8), but is not limited thereto, and it is preferable that the cross-sectional shape be a mountain shape in which the straight section (S) and the curved section (C) are harmoniously repeated, so that the distance between the contact points (P) for the transducer (130) is reduced compared to the existing circular pattern (see FIG. 9).

[0077] The second position adjustment unit (114) is interposed between the first position adjustment unit (113) and the transducer (130) to support the transducer (130) while being connected to the first position adjustment unit (113) in a hinge structure, and changes the angle that the transducer (130) forms with the head (10) while tilting the transducer (130), and moves the transducer (130) to at least one area among the top, bottom, left, and right of the head (10) while rotating the transducer (130) based on the connection point with the first position adjustment unit (114) to individually change the position of the transducer (130) with the first position adjustment unit (113).

[0078] This second position adjustment unit (114), as shown in FIG. 3, comprises a first torque ball hinge (114a) that is movably coupled when a preset pressure is applied to the first coupling groove (1131d) of the first position adjustment unit (113), a joint hinge portion (114b) that is formed by coupling one end of the first torque ball hinge (114a) to have an arbitrary length and tilting when a preset pressure is applied by dividing the extended length into two, a second torque ball hinge (114c) that is formed in the same shape as the first torque ball hinge (114a) and coupled to the other end of the joint hinge portion (114b), and a second coupling groove (1141d) that is movably coupled when a preset pressure is applied to the second torque ball hinge (114c) on one end, and on the other end It can be configured to include a bracket (114d) in which a mounting portion (1142d) is formed to support the case (141) of the transducer (130) by compression.

[0079] At this time, according to the present invention, the mounting portion (1142d) is formed with an inner diameter smaller than the outer diameter of the transducer (130) to support and hold the transducer (130) with a preset tension when the transducer (130) is mounted, and its shape is preferably configured to cover a radius of the transducer (130) or more, and a part thereof is preferably formed of a silicone material to prevent detachment due to slip of the transducer (130).

[0080] The transducer (130) may be composed of an array of multiple ultrasonic probes and has a structure that stimulates at a low intensity. The ultrasonic probe array of the transducer (130) may be (1) a structure in which multiple ultrasonic element lines are arranged in a circular or symmetrical shape that are configured coaxially, (2) a structure in which multiple disc-shaped (circular or square) ultrasonic elements are arranged to face a specific direction, or (3) a single piece of piezoelectric material. The multiple ultrasonic probes of the transducer (130) may have a function of focusing ultrasonic waves at a specific location by adjusting their respective phases, and may also control the direction of ultrasonic waves (beam steering) by adjusting the phases. In the case of a single-piece transducer, the geometry and orientation of the transducer determine the beam focus position and direction of the ultrasonic waves. The transducer may have a focused or unfocused configuration depending on the acoustic field.

[0081] The detailed description of the preferred embodiments of the present invention disclosed above has been provided to enable those skilled in the art to implement and practice the present invention. While the above description has been made with reference to preferred embodiments of the present invention, those skilled in the art will appreciate that various modifications and variations can be made to the present invention without departing from the scope of the present invention. For example, those skilled in the art can utilize the individual components described in the above-described embodiments in combination with each other. Accordingly, the present invention is not intended to be limited to the embodiments described herein but is to be accorded the widest scope consistent with the principles and novel features disclosed herein.

[0082] The present invention may be embodied in other specific forms without departing from the spirit and essential characteristics thereof. Therefore, the above detailed description should not be construed in any way as limiting but rather as illustrative. The scope of the present invention should be determined by a reasonable interpretation of the appended claims, and all changes coming within the equivalent scope of the claims are intended to be included therein. The present invention is not intended to be limited to the embodiments set forth herein but is to be accorded the widest scope consistent with the principles and novel features disclosed herein. Furthermore, claims that are not explicitly cited in the claims may be combined to form an embodiment or incorporated into a new claim by post-application amendment.

[0083] Description of the symbol

[0084] 10: Head,

[0085] 20: Structure,

[0086] 21: Ultrasonic stimulator,

[0087] 30: Ultrasound,

[0088] 100: Mobile Ultrasonic Stimulation Headgear,

[0089] 110: Head frame,

[0090] 111: 1st support,

[0091] 112: Second support,

[0092] 112a: 1st Band Division,

[0093] 112b: 2nd band section,

[0094] 113: 1st position adjustment unit,

[0095] 113a: Guide home,

[0096] 113b: elastic body,

[0097] 113c: Guide rail,

[0098] 1131c: Rough pattern,

[0099] 113d: Guider,

[0100] 1131d: First joining groove,

[0101] 114: Second position adjustment unit,

[0102] 114a: First torque ball hinge,

[0103] 114b: Joint hinge,

[0104] 114c: Second torque ball hinge,

[0105] 114d : Bracket,

[0106] 1141d: Second joining groove,

[0107] 1142d: Settling part,

[0108] 120: Ultrasonic generator,

[0109] 130: Transducer,

[0110] 140: Pulse Bundle,

[0111] 150 : Pulse,

[0112] S: straight line,

[0113] C: bend,

[0114] P: contact point,

[0115] T / T: Total ultrasonic treatment time (Treatment Time),

[0116] SI: Sonication Interval of pulse bundle (sonication treatment),

[0117] SD: Pulse bundle (sonication duration) width,

[0118] TBD: Tone Burst Duration,

[0119] PRP: Pulse Repetition Period,

[0120] PRF: Pulse Repetition Frequency

Claims

1. An ultrasonic generator having a low intensity of ISPPA (Intensity Spatial Peak Pulse Average) 50 W / cm2 or less, which generates a pulse bundle consisting of pulses of a first frequency using ultrasonic waves, and forms and outputs a second frequency using the pulse bundle; A transducer connected to the above ultrasonic generator and irradiating ultrasonic waves toward the brain of a mammal to cause ultrasonic stimulation in the frontal lobe region of the brain; and A head frame equipped with the above transducer and configured to be wearable on the head of the mammal, The above transducer, The head frame is mounted so as to be able to adjust the position and angle formed with the head through the rail structure and hinge structure provided on the head frame, and moves along the head, so that the stimulation position of the frontal lobe of the brain stimulated by the ultrasound irradiation is selectively adjusted. The above head frame, A first support member having a semicircular shape having a curvature along the head circumference of the mammal and forming a frontal area based on the head when worn on the head; A second support part, which is connected to the first support part and is worn on the head, forms a rear region based on the head; A first position adjustment unit provided in the form of a rail structure on the front of the first support unit to change the position of the transducer with respect to the head while sliding the transducer to the left and right sides of the head; and A second position adjustment unit is interposed between the position adjustment unit and the transducer to support the transducer while being connected to the first position adjustment unit in a hinge structure, and changes the angle that the transducer forms with the head while tilting the transducer, and moves the transducer to at least one area among the top, bottom, left, and right of the head while rotating the transducer based on the connection point with the first position adjustment unit, thereby individually changing the position of the transducer with the first position adjustment unit. The above second support part, It is characterized by being composed of a first band part and a second band part, each of which includes a hair band made of an elastic material having elasticity and branching from the end of the first support part, The above first and second bands are, The transducer is hinged to the same axis as the first support member and moves to the front and rear sides of the head, The above first position adjustment unit, A guide groove formed on the front surface of the first support portion so as to extend to an arbitrary length toward the left and right sides of the head; An elastic body provided in the above guide groove; A guide rail having a preset pattern of protrusions along the guide groove and coupled to the elastic body; and A guider is included, one side of which is inserted into the guide groove and connected to the elastic body while being coupled to the guide rail, and slides along the guide rail while being pressed by the elastic body, and a first coupling groove in the shape of a ball is formed on the other side. The above low intensity is characterized by ISPPA 25 W / cm2 or less, The above first frequency is characterized by being 10 to 10,000 Hz, The above second frequency is 1.4 Hz or more and less than 10 Hz, The above rough pattern is, It is characterized in that it has a resolution of 3 to 4 degrees for the movement angle of the transducer per step and 5 to 10 mm for the straight-line distance, A mobile ultrasound stimulation headgear for sleep characterized by a cross-sectional shape in which straight and curved sections are harmoniously repeated, thereby reducing the distance between contact points for the transducer compared to a circular pattern.

2. In paragraph 1, The above second position adjustment unit, A first torque ball hinge that is flexibly coupled when a preset pressure is applied corresponding to the first coupling groove of the first position adjustment part; A joint hinge part having a joint structure in which one end is connected to the first torque ball hinge and extended to have an arbitrary length, and the extended length is divided into two and tilted when a preset pressure is applied; A second torque ball hinge having the same shape as the first torque ball hinge and coupled to the other end of the joint hinge portion; and A mobile ultrasonic stimulation headgear for sleep, characterized in that it includes a bracket having a second coupling groove formed on one side that is movably coupled when a preset pressure is applied in response to the second torque ball hinge, and a mounting portion formed on the other side that supports the transducer by compression.

3. In paragraph 2, The above-mentioned fixing part is, A mobile ultrasound stimulation headgear for sleep, characterized in that the inner diameter is formed smaller than the outer diameter of the transducer, the transducer is held and supported with a preset tension when the transducer is installed, the shape is formed to cover a radius of the transducer or more, and a portion is made of a silicone material to prevent the transducer from being detached due to slipping.

4. In paragraph 1, The output signal of the above transducer is A mobile ultrasound stimulation headgear for sleep characterized by the current and voltage of the above transducer.

5. In paragraph 1, The above ultrasonic generator, It is characterized by operating in the range of 60 seconds to 3,600 seconds, The above transducer, A mobile ultrasound stimulation headgear for sleep, characterized in that 90% of the focused energy is configured to form a focus of 10 mm or less at a distance of 10 to 40 mm from the surface of the transducer.

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