State improvement promotion device and state improvement promotion method

Abstract

According to the present invention, at a site where the outer surface of the head of a subject is in contact with a vibration generation part that generates ultrasonic vibration and low-frequency vibration at a vibration frequency of not more than 100 Hz, a scattering induction part which induces scattering of the ultrasonic vibration and the low-frequency vibration is attached, and the vibration generation part is driven and controlled so that the vibration energy of the ultrasonic vibration and the low-frequency vibration propagates through the entirety of a target region in the brain of the subject.

Description

Condition improvement promotion device and condition improvement promotion method

[0001] The present invention aims to propose a condition improvement promotion device and a condition improvement promotion method that promote improvement of microcirculation in the brain tissue of a subject and improvement of dementia in the subject by physical stimulation, particularly through ultrasonic vibrations or low-frequency vibrations.

[0002] As Japan's population ages, the number of dementia patients in the country is on the rise. In particular, vascular dementia and Alzheimer's disease account for the majority of dementia cases, and many patients exhibit symptoms of both diseases.

[0003] Common methods of treating vascular dementia include drug treatment for high blood pressure, dyslipidemia, and diabetes, as well as promoting exercise, quitting smoking, preventing overeating, and reducing stress. However, no pharmaceutical treatment for vascular dementia itself has yet been developed.

[0004] In recent years, a method for treating dementia has been proposed in which low-intensity pulsed ultrasound (LIPUS) is irradiated onto the brain with the aim of inducing vascularization and neuronal proliferation in the human brain (see Patent Document 1).

[0005] This dementia treatment involves irradiating low-intensity pulsed ultrasound, which increases the expression of endothelial NO synthase (eNOS) through a mechanism mediated by physical stimulation of the caveolin-1 / β-integrin complex present in the vascular endothelial cell membrane. As a result, downstream processes such as a reduction in amyloid-β accumulation, suppression of microglial activity, angiogenesis, and remyelination are induced, resulting in a treatment that suppresses cognitive decline through a complex mechanism of action.

[0006] Patent Publication No. 2018-181991

[0007] The dementia treatment method described in Patent Document 1 is a method in which, with multiple ultrasonic probes placed on the surface of the head, unfocused ultrasonic energy that diffuses in an inverse tapered shape between the multiple ultrasonic probes is sequentially irradiated at intervals of 0.15 / f ms or more (f indicates the frequency (MHz) of the transmitted pulse).

[0008] However, in this dementia treatment method, where ultrasound waves are attenuated as they propagate through the brain and as they reflect off the skull, a method in which unfocused ultrasound energy is sequentially irradiated between multiple ultrasound probes at predetermined time intervals can prevent excessive ultrasound stimulation even if the unfocused ultrasound energy generated one after the other overlaps, but further ingenuity is needed to efficiently propagate vibration energy throughout the target area in the brain.

[0009] The present invention has been made in consideration of the above points, and aims to propose a condition improvement promotion device and a condition improvement promotion method that can improve microcirculation in brain tissue and improve dementia.

[0010] In order to solve such problems, in the present invention, a condition improvement promotion device for improving the microcirculation in the brain tissue of a subject and promoting the improvement of dementia in the subject is provided with a vibration generating unit that generates ultrasonic vibrations and low-frequency vibrations with a vibration frequency of 100 Hz or less, a scattering inducing unit that is attached to the contact point of the vibration generating unit with the outer surface of the subject's head and induces scattering of the ultrasonic vibrations and low-frequency vibrations, and a control unit that drives and controls the vibration generating unit so that the vibration energy of the ultrasonic vibrations and low-frequency vibrations is propagated throughout the entire target area in the subject's brain.

[0011] In this way, with the condition improvement promotion device, the subject wears the vibration generating unit on their head via the scattering inducing unit, and ultrasonic vibrations and low-frequency vibrations are scattered and irradiated, thereby propagating vibration energy throughout the target area in the brain and activating a complex mechanism of action within the brain, thereby improving microcirculation in brain tissue and making it possible to alleviate dementia.

[0012] In addition, in the present invention, the vibration generating units are attached so that multiple units are arranged around the subject's head, and the control unit controls the drive of each vibration generating unit so that a phase difference occurs between the ultrasonic vibrations and low-frequency vibrations from each vibration generating unit.

[0013] As a result, in the condition improvement promotion device, by irradiating multiple ultrasonic vibrations and low-frequency vibrations with a phase difference that are propagated into the subject's brain, it is possible for the vibration energy that passes through the brain to propagate throughout the entire target area within the brain without resonating.

[0014] Furthermore, the present invention further includes a vibration receiving unit that receives ultrasonic vibrations and low-frequency vibrations transmitted through the contact point with the outer surface of the subject's head, and the control unit constantly monitors the intensity of the vibration energy of the ultrasonic vibrations and low-frequency vibrations received by the vibration receiving unit to maintain it below a predetermined level while controlling the drive of the vibration generating unit when the intensity is above a predetermined level.

[0015] As a result, the condition improvement promotion device constantly monitors the vibration energy of the ultrasonic vibrations and low-frequency vibrations propagated into the subject's brain to ensure that it does not become excessive, thereby preventing any adverse effects on the subject's brain caused by the application of this device and ensuring safety.

[0016] Furthermore, in the present invention, the scattering induction section is made up of a thin, envelope-like body containing fine particles of ultrasound scatterers having predetermined scattering properties scattered throughout a liquid, gel, or polymer medium.

[0017] As a result, in the condition improvement promotion device, when the subject wears the vibration generating unit on his or her head, the scattering inducing unit that is inserted between the vibration generating unit and the contact point on the outer surface of the head is made of a relatively flexible object, thereby making it possible to reduce discomfort to the subject's head.

[0018] Furthermore, in the present invention, the scattering-inducing section comprises a thin, envelope-like body containing point-like scatterers made of gas bubbles scattered throughout the liquid medium, and the control section controls either or both of the arrangement and distribution state of the point-like scatterers in the scattering-inducing section to a desired state, thereby adjusting the scattering characteristics of the ultrasonic vibrations and low-frequency vibrations.

[0019] As a result, the condition improvement promotion device can adjust the scattering characteristics of the scattering induction part that is abutted against the contact point on the outer surface of the subject's head to the desired state, making it possible to optimize the propagation state of vibration energy throughout the target area within the brain.

[0020] Furthermore, in the present invention, the scattering induction section consists of a thin, envelope-like body filled with magnetic fluid, and the control section controls either or both of the arrangement and distribution state of the ferromagnetic microparticles contained in the magnetic fluid in the scattering induction section to a desired state, thereby adjusting the scattering characteristics of the ultrasonic vibrations and low-frequency vibrations.

[0021] As a result, the condition improvement promotion device can adjust the scattering characteristics of the scattering induction part that is abutted against the contact point on the outer surface of the subject's head to the desired state, making it possible to optimize the propagation state of vibration energy throughout the target area within the brain.

[0022] Furthermore, in the present invention, the vibration energy of the ultrasonic vibration and low-frequency vibration generated by the vibration generating unit has a vibration generating sound pressure of 0.1 to 1.5 MPa, and the irradiation time for a single use on a subject is set to a maximum of 20 minutes, and in the case of repeated use, the upper limit is set to a total of 60 minutes of irradiation per day with a 5-minute interval.

[0023] In this way, with the condition improvement promotion device, the sound pressure generated by the piezoelectric vibrator in the vibration generating unit is set within a range that provides an appropriate tissue amplitude to the brain, and by setting a limit on the irradiation time for a single use and also setting an upper limit on the sense of time when repeated use and the total time per day, it is possible to maintain the effect of improving the microcirculation of the subject's brain tissue and the effect of suppressing the decline in cognitive function for a relatively long period of time, for more than three months after use.

[0024] Furthermore, in the present invention, the vibration energy of the ultrasonic vibrations and low-frequency vibrations generated by the vibration generating unit is dispersed in all directions while scattering from the direction of irradiation, and the ultrasonic and low-frequency vibrations stimulate vascular cells, promoting the expression of eNOS (endothelial nitric oxide synthase), VEGF (vascular endothelial growth factor), and bFGF (basic fibroblast growth factor).

[0025] In this way, the condition improvement promotion device scatters the vibration energy of ultrasonic vibrations and low-frequency vibrations in all directions while scattering them from the direction of irradiation, thereby enhancing the expression of eNOS (endothelial nitric oxide synthase), VEGF (vascular endothelial growth factor), and bFGF (basic fibroblast growth factor), thereby achieving an improvement in the microcirculation of the subject's brain tissue and an improvement in dementia.

[0026] Furthermore, in the present invention, in a method for promoting improvement of a condition to improve the microcirculation in the brain tissue of a subject and promote improvement of dementia in the subject, a scattering inducing unit that induces scattering of the ultrasonic vibrations and low-frequency vibrations is attached to a vibration generating unit that generates ultrasonic vibrations and low-frequency vibrations with a vibration frequency of 100 Hz or less at a contact site with the outer surface of the subject's head, and the vibration generating unit is driven and controlled so that the vibration energy of the ultrasonic vibrations and low-frequency vibrations is propagated throughout the entire target area in the subject's brain.

[0027] In this method for promoting improvement of a condition, the subject wears the vibration generating unit on his or her head via the scattering inducing unit, and ultrasonic vibrations and low-frequency vibrations are scattered and irradiated, thereby propagating vibration energy throughout the target area in the brain and activating a complex mechanism of action within the brain, thereby improving microcirculation in brain tissue and alleviating dementia.

[0028] According to the present invention, it is possible to realize a condition improvement promotion device and a condition improvement promotion method that can efficiently propagate vibration energy throughout the target area in the brain, activate a complex mechanism of action in the brain, improve microcirculation in brain tissue, and improve dementia.

[0029] Fig. 1 is an external perspective view showing the configuration of a condition improvement promoting device according to the present embodiment. Fig. 2 is a conceptual diagram showing the circuit configuration of a control system in the condition improvement promoting device shown in Fig. 1. Fig. 3 is a conceptual diagram showing the circuit configuration of a control system in a condition improvement promoting device when a scattering inducing unit of a second embodiment is applied. Fig. 4 is a conceptual diagram showing the circuit configuration of a control system in a condition improvement promoting device when a scattering inducing unit of a third embodiment is applied.

[0030] An embodiment of the present invention will be described in detail below with reference to the drawings.

[0031] (1) Configuration of the Condition Improvement Promotion Device According to the Present Embodiment Fig. 1 is a schematic external view of a condition improvement promotion device 1 according to the present embodiment. This condition improvement promotion device 1 has a pair of vibration generating units 2 to be attached to the outer surface of the subject's head, and a control unit 3 for driving and controlling each of the vibration generating units 2. The pair of vibration generating units 2 and the control unit 3 are connected to each other via wire or wirelessly so as to be able to communicate with each other.

[0032] The pair of vibration generating units 2 are made of piezoelectric vibrators (piezoelectric ceramic vibrators, piezoelectric single crystal vibrators, polymer piezoelectric film vibrators, etc.) or magnetostrictive vibrators (ferrite magnetostrictive vibrators, etc.) that generate ultrasonic vibrations and low-frequency vibrations with a vibration frequency of 100 Hz or less.

[0033] Each pair of vibration generating units 2 is fitted with a scattering inducing unit 4 at the contact point with the outer surface of the subject's head to induce scattering of the ultrasonic vibrations and low-frequency vibrations generated from each piezoelectric vibrator (or magnetostrictive vibrator).

[0034] The subject wears the pair of vibration generating units 2 of the condition improvement promotion device 1 so that the scattering inducing units 4 are in contact with the left and right temporal bones (temples), which are the thinnest parts of the skull in the subject's head. By selecting the temporal bones (temples) as the contact points with the outer surface of the head, it is possible to relatively improve the transmission efficiency of ultrasonic vibrations and low-frequency vibrations to the brain.

[0035] In this way, with the condition improvement promotion device 1, the subject wears the vibration generating unit 2 on their head via the scattering inducing unit 4, and by scattering and irradiating ultrasonic vibrations and low-frequency vibrations, the vibration energy is propagated throughout the target area in the brain, causing a complex mechanism of action within the brain to be activated, improving microcirculation in brain tissue and making it possible to alleviate dementia.

[0036] (2) Method of driving and controlling a pair of vibration generating units Figure 2 shows the circuit configuration of the control system in the condition improvement promotion device 1. The condition improvement promotion device 1 has a control unit 3 that includes a general control unit 10 that controls the entire device and is made up of an MCM (Multi-Chip Module) equipped with a CPU (Central Processing Unit), memory, etc., and a storage unit 11 that reads and writes various data under the control of the general control unit 10.

[0037] The integrated control unit 10 controls the driving of each vibration generating unit 2 so that the vibration energy of the ultrasonic vibration and the low-frequency vibration is propagated throughout the entire target region in the brain of the subject.

[0038] According to experiments, the conditions for the vibration energy of the ultrasonic vibration and low-frequency vibration generated by the vibration generating unit 2 are set as follows: the vibration generation sound pressure is 0.1 to 1.5 MPa, the irradiation time for a single use on the subject is a maximum of 20 minutes, and in the case of repeated use, the irradiation time is set to a maximum of 60 minutes in total per day with a 5-minute interval.

[0039] In this way, in the condition improvement promotion device 1, the sound pressure generated by the piezoelectric vibrator (or magnetostrictive vibrator) in the vibration generating unit 2 is set within a range that gives an appropriate tissue amplitude to the brain, and by setting a limit on the irradiation time for a single use and also setting an upper limit on the sense of time when repeated use and the total time per day, it is possible to maintain the effect of improving the microcirculation of the subject's brain tissue and the effect of suppressing the decline of cognitive function for a relatively long period of time, for more than three months after use.

[0040] The function of promoting improvement of the condition by irradiating the vibration energy of ultrasonic vibrations and low-frequency vibrations generated by the vibration generating unit 2 is that the vibration energy of the ultrasonic vibrations and low-frequency vibrations is scattered in all directions from the direction of irradiation, and the ultrasonic and low-frequency vibrations stimulate vascular cells in the brain of the subject, thereby promoting the expression of eNOS (endothelial nitric oxide synthase), VEGF (vascular endothelial growth factor), and bFGF (basic fibroblast growth factor).

[0041] In this way, with the condition improvement promotion device 1, the vibration energy of the ultrasonic vibrations and low-frequency vibrations is scattered from the direction of irradiation and diffused in all directions, thereby enhancing the expression of eNOS (endothelial nitric oxide synthase), VEGF (vascular endothelial growth factor), and bFGF (basic fibroblast growth factor), thereby achieving the effect of improving microcirculation in the brain tissues of the subject and the effect of improving dementia.

[0042] Furthermore, in the condition improvement promotion device 1, the integrated control unit 10 controls the drive of each of the pair of vibration generating units 2 so that a phase difference occurs between the ultrasonic vibrations and the low-frequency vibrations, thereby enabling the vibration energy passing through the subject's brain to propagate throughout the entire target area within the brain without resonating.

[0043] Furthermore, the condition improvement promotion device 1 is provided with a vibration receiving unit 12 near the pair of vibration generating units 2, which receives ultrasonic vibrations and low-frequency vibrations transmitted via contact points with the outer surface of the subject's head. When the intensity of the vibration energy of the ultrasonic vibrations and low-frequency vibrations received by the vibration receiving unit 12 is equal to or greater than a predetermined level, the overall control unit 10 constantly monitors the vibration generating units 2 while controlling their operation to maintain the intensity below the predetermined level.

[0044] As a result, the condition improvement promotion device 1 constantly monitors the vibration energy of the ultrasonic vibrations and low-frequency vibrations propagated into the subject's brain to ensure that it does not become excessive, thereby preventing any adverse effects on the subject's brain caused by the application of this device and ensuring safety.

[0045] In addition, while irradiating ultrasonic vibration and low-frequency vibration energy from a pair of vibration generating units 2, if the intensity of the ultrasonic vibration and low-frequency vibration energy received by the vibration receiving unit 12 is above a predetermined level, the integrated control unit 10 may constantly monitor the drive and control of the vibration generating units 2 to maintain the intensity below the predetermined level, and at the same time, appropriately change the phase difference of the ultrasonic vibration and low-frequency vibration for both vibration generating units 2.

[0046] (3) Configuration of the scattering-inducing section (3-1) Configuration of the scattering-inducing section in the first embodiment The scattering-inducing section 4 in the first embodiment consists of a thin, envelope-like body containing fine particles made of ultrasound scatterers having predetermined scattering properties scattered throughout a liquid (e.g., water), gel, or polymer medium.

[0047] Here, scattering refers to the phenomenon in which reflected waves are scattered in all directions when ultrasonic waves are incident on an irregular boundary surface or a minute reflector. Ultrasonic scatterers may be of various sizes, shapes, and materials, as long as they are particles that can induce forward scattering of ultrasonic vibrations and low-frequency vibrations generated from a vibration generating unit (piezoelectric vibrator or magnetostrictive vibrator).

[0048] As a result, in the condition improvement promotion device 1, when the subject wears the vibration generating unit 2 on his or her head, the scattering inducing unit 4 that is inserted between the vibration generating unit 2 and the contact point on the outer surface of the head is made of a relatively flexible object, thereby making it possible to reduce discomfort to the subject's head.

[0049] (3-2) Configuration of the Scattering Inducing Unit in the Second Embodiment The scattering inducing unit 20 in the second embodiment is a thin-plate envelope containing point-like scatterers 21 made of gas bubbles scattered throughout a liquid medium. The integrated control unit 10 adjusts the scattering characteristics of the ultrasonic vibrations and low-frequency vibrations by controlling either or both of the arrangement and distribution of the point-like scatterers 21 in the scattering inducing unit 20 to a desired state ( FIG. 3 ).

[0050] As a result, the condition improvement promotion device 1 can adjust the scattering characteristics of the scattering induction unit 20 that is abutted against the contact area on the outer surface of the subject's head to the desired state, making it possible to optimize the propagation state of vibration energy throughout the target area within the brain.

[0051] (3-3) Configuration of the Scattering Inducing Unit in the Third Embodiment The scattering inducing unit 30 in the third embodiment is made of a thin, envelope-like body filled with a magnetic fluid 31. The integrated control unit 10 adjusts the scattering characteristics of the ultrasonic vibrations and low-frequency vibrations by controlling either or both of the arrangement and distribution of the ferromagnetic microparticles contained in the magnetic fluid 31 in the scattering inducing unit 30 to a desired state ( FIG. 4 ).

[0052] The magnetic fluid 31 is a colloidal solution in which magnetic iron oxide nanoparticles are dispersed extremely stably in a liquid, and is a composite material consisting of magnetic particles (e.g., magnetite (Fe3O4) or maghemite (γ-Fe2O3)) as the dispersoid (solute), a solvent as the dispersion medium (solvent), and ions or surfactants as the dispersants.

[0053] In the absence of an external magnetic field, the magnetic moments of the magnetic particles rotate randomly in the liquid, canceling each other out and resulting in no magnetization of the fluid as a whole. However, in the presence of an external magnetic field, the magnetic moment of each nanoparticle orients itself in the direction of the magnetic field lines, causing the fluid to behave as if it were magnetized.

[0054] Taking advantage of these characteristics of the magnetic fluid, the integrated control unit 10 controls the particle size, particle size distribution, shape and aggregate size of the ferromagnetic microparticles contained in the magnetic fluid 31 in the scattering induction unit 30, thereby controlling either or both of the arrangement and distribution state of the ferromagnetic microparticles to the desired state, thereby adjusting the scattering characteristics of the ultrasonic vibrations and low-frequency vibrations.

[0055] As a result, the condition improvement promotion device 1 can adjust the scattering characteristics of the scattering induction unit 30 that is abutted against the contact area on the outer surface of the subject's head to the desired state, making it possible to optimize the propagation state of vibration energy throughout the target area within the brain.

[0056] (4) Other embodiments In this embodiment, the left and right temporal regions (temples) of the subject's head are selected as contact points with the outer surface of the head in the condition improvement promotion device 1, and a vibration generating unit 2 is attached to each of them. However, the present invention is not limited to this, and the number of vibration generating units 2 attached may be freely set to not only two, but also one, or three or more.

[0057] For example, in addition to the left and right temporal regions (temples), the boundary between the occipital region and the top of the head (foramen magnum) may also be selected as a contact site with the outer surface of the subject's head.

[0058] Furthermore, in this embodiment, the scattering inducing units 4, 20, 30 are described as being configured and controlled in the manner described above for the first to third embodiments, but the present invention is not limited to this. In essence, as long as the scattering of the ultrasonic vibrations and low-frequency vibrations irradiated from the vibration generating unit 2 can be induced to a desired state, various scattering inducing units may be applied as long as they are configured to be attachable to the contact point of the vibration generating unit 2 with the outer surface of the subject's head.

[0059] 1...condition improvement promotion device, 2...vibration generating section, 3...control unit, 4, 20, 30...scattering inducing section, 10...general control section, 11...memory section, 12...vibration receiving section, 21...point-like scatterer, 31...magnetic fluid

Claims

1. A condition improvement promotion device for promoting improvement of microcirculation in the brain tissues of a subject and improvement of dementia in the subject, comprising: a vibration generating unit that generates ultrasonic vibrations and low-frequency vibrations with a vibration frequency of 100 Hz or less; a scattering inducing unit that is attached to the vibration generating unit at a contact point with the outer surface of the subject's head and induces scattering of the ultrasonic vibrations and the low-frequency vibrations; and a control unit that drives and controls the vibration generating unit so that the vibration energy of the ultrasonic vibrations and the low-frequency vibrations is propagated throughout the entire target area in the brain of the subject.

2. The condition improvement promotion device described in claim 1, characterized in that the vibration generating units are attached so as to be arranged in multiple positions around the subject's head, and the control unit drives and controls each of the vibration generating units so that a phase difference occurs between the ultrasonic vibration and the low-frequency vibration.

3. A condition improvement promotion device as described in claim 1 or 2, further comprising a vibration receiving unit that receives the ultrasonic vibrations and the low-frequency vibrations transmitted through the contact point with the outer surface of the subject's head, wherein the control unit constantly monitors the intensity of the vibration energy of the ultrasonic vibrations and the low-frequency vibrations received by the vibration receiving unit to maintain it below a predetermined level while controlling the drive of the vibration generating unit when the intensity is above a predetermined level.

4. A condition improvement promotion device as described in claim 1 or 2, characterized in that the scattering induction section consists of a thin, plate-like envelope containing fine particles made of ultrasonic scatterers with predetermined scattering properties scattered throughout a liquid, gel, or polymer medium.

5. The condition improvement promoting device described in claim 1 or 2, characterized in that the scattering inducing section is made of a thin, envelope-like body containing point-like scatterers made of gas bubbles scattered throughout the liquid medium, and the control section adjusts the scattering characteristics of the ultrasonic vibrations and the low-frequency vibrations by controlling either or both of the arrangement and distribution state of the point-like scatterers in the scattering inducing section to a desired state.

6. A condition improvement promotion device as described in claim 1 or 2, characterized in that the scattering induction section consists of a thin, envelope-shaped body filled with magnetic fluid, and the control section adjusts the scattering characteristics of the ultrasonic vibrations and the low-frequency vibrations by controlling either or both of the arrangement and distribution state of the ferromagnetic microparticles contained in the magnetic fluid in the scattering induction section to a desired state.

7. A condition improvement promotion device as described in claim 1 or 2, characterized in that the vibration energy of the ultrasonic vibration and the low-frequency vibration generated by the vibration generating unit has a vibration generation sound pressure of 0.1 to 1.5 MPa, the irradiation time for the subject in one use is set to a maximum of 20 minutes, and in the case of repeated use, the upper limit is set to a total of 60 minutes of irradiation per day with a 5-minute interval between irradiations.

8. A condition improvement promotion device as described in claim 1 or 2, characterized in that the vibration energy of the ultrasonic vibrations and low-frequency vibrations generated by the vibration generating unit is diffused in all directions while scattering from the direction of irradiation, and the ultrasonic and low-frequency vibrations stimulate vascular cells and promote the expression of eNOS, VEGF, and bFGF.

9. A method for promoting improvement of a condition in a subject for improving the microcirculation in the brain tissues and for promoting improvement of the subject's dementia, comprising attaching a scattering inducing unit that induces scattering of the ultrasonic vibrations and the low-frequency vibrations to a vibration generating unit that generates ultrasonic vibrations and low-frequency vibrations with a vibration frequency of 100 Hz or less at a contact site with the outer surface of the subject's head, and driving and controlling the vibration generating unit so that the vibration energy of the ultrasonic vibrations and the low-frequency vibrations is propagated throughout the entire target area in the brain of the subject.

10. A method for promoting improvement of a condition as described in claim 9, characterized in that, when a plurality of the vibration generating units are placed and worn around the subject's head, the ultrasonic vibrations and the low-frequency vibrations from each vibration generating unit are driven and controlled so that a phase difference occurs between them.

11. A method for promoting improvement of a condition as described in claim 9 or 10, characterized in that the ultrasonic vibrations and the low-frequency vibrations transmitted through the contact points with the outer surface of the subject's head are received, and when the intensity of the vibration energy of the received ultrasonic vibrations and the low-frequency vibrations is above a predetermined level, the vibration generating unit is driven and controlled while constantly monitoring to maintain the intensity below the predetermined level.

12. A method for promoting condition improvement as described in claim 9 or 10, characterized in that the scattering induction part consists of a thin, plate-like envelope containing fine particles made of ultrasonic scatterers having predetermined scattering properties scattered throughout a liquid, gel, or polymer medium.

13. A condition improvement promotion method as described in claim 9 or 10, characterized in that the scattering induction section is made of a thin, envelope-like body containing point-like scatterers made of gas bubbles scattered throughout a liquid medium, and the scattering characteristics of the ultrasonic vibration and the low-frequency vibration are adjusted by controlling either or both of the arrangement and distribution state of the point-like scatterers in the scattering induction section to a desired state.

14. A method for promoting condition improvement as described in claim 9 or 10, characterized in that the scattering induction section consists of a thin, envelope-shaped body filled with magnetic fluid, and the scattering characteristics of the ultrasonic vibration and the low-frequency vibration are adjusted by controlling either or both of the arrangement and distribution state of the ferromagnetic microparticles contained in the magnetic fluid in the scattering induction section to a desired state.

15. A method for promoting improvement of a condition as described in claim 9 or 10, characterized in that the vibration energy of the ultrasonic vibration and the low-frequency vibration generated by the vibration generating unit has a vibration generation sound pressure of 0.1 to 1.5 MPa, the irradiation time for a single use on the subject is set to a maximum of 20 minutes, and in the case of repeated use, the upper limit is set to a total of 60 minutes of irradiation per day with a 5-minute interval between each use.

16. A method for promoting improvement of a condition as described in claim 9 or 10, characterized in that the vibration energy of the ultrasonic vibration and the low-frequency vibration generated by the vibration generating unit is scattered in all directions from the direction of irradiation, stimulating vascular cells with the ultrasonic and low-frequency vibrations and promoting the expression of eNOS, VEGF, bFGF, etc.

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