Transcranial optomagnetic nerve regulation and control device

Abstract

The invention provides a transcranial optomagnetic nerve regulation and control device, and the device comprises a magnetic stimulation module which comprises a magnetic stimulation coil for applying transcranial magnetic stimulation; the light stimulation module is arranged corresponding to the magnetic stimulation module, the light stimulation module comprises a light source part and a diffusion assembly, the light source part emits near-infrared light, the diffusion assembly is arranged on the wearing side of the magnetic stimulation coil, and the diffusion assembly receives the near-infrared light from the light source part and diffuses the near-infrared light; the diffused near-infrared light is emitted from the emitting surface of the diffusion component so as to irradiate the head of a user; the light source part is arranged at the position where the magnetic field intensity of the magnetic stimulation coil is smaller than a first threshold value. When the device is used, the interference between the optical stimulation module and the magnetic stimulation module is remarkably reduced, the optical-magnetic regulation and control can be effectively and synergistically executed on the target brain area in the time domain and the space domain, meanwhile, the brain volume wide enough and the deeper position under the cerebral cortex can be stimulated, and the treatment effect is effectively improved.

Description

Technical Field

[0001] The present invention relates to the technical field of medical devices, and in particular, to a transcranial nerve regulation device, and more particularly, to a transcranial optical magnetic nerve regulation device. Background Art

[0002] Transcranial Magnetic Stimulation (TMS) is a painless, non-invasive physical therapy method. It uses the high-voltage capacitor in the stimulation generator to generate high-voltage current to act on the magnetic stimulation coil. The time-varying magnetic field generated in the coil passes through the skull, stimulates the cerebral cortex and peripheral nerves, generates induced current, changes the action points of nerve cells, affects the metabolism of neurotransmitters and neural electrical activity in the brain, and thus triggers a series of physiological and biochemical reactions, such as regulating the excitability of the cerebral cortex, changing the connection between synapses, repairing incompletely damaged nerve cells, affecting cerebral blood flow and blood oxygen levels, promoting the release of neurotransmitters in the brain, stimulating the secretion of neurotrophic factors and inducing neural network oscillations. The continued effect during and after TMS stimulation can be used to regulate the function of the nervous system. It has been applied in various aspects such as neuropsychology (depression, schizophrenia), rehabilitation, and pediatrics (cerebral palsy, autism, etc.). Some studies have confirmed that TMS stimulation can also have a certain therapeutic effect on Alzheimer's disease (AD) or mild cognitive impairment (MCI).

[0003] Usually, the stimulation depth of magnetic stimulation coils is relatively shallow, only 1.5cm-3cm. Although it can be indirectly transmitted to remote sites through the neural network connection of the stimulation area, or through improved stimulation coils, such as double-cone coils, H-shaped coils, etc., the stimulated brain volume is still not wide enough.

[0004] Near-infrared light stimulation equipment is also used to treat AD or MCI. It triggers a series of physiological and biochemical reactions by irradiating the brain with appropriate doses of near-infrared light. Its mechanism of action is different from TMS. It can significantly reduce the volume and number of Aβ plaques in the cerebral cortex and hippocampus, and reduce the aggregation of hyperphosphorylated tau protein. It can be seen that AD is a whole-brain disease and also has targeted sites in the brain functional network. If TMS can be used in conjunction with near-infrared light stimulation to treat AD or MCI, it can not only clear the deposition of β-amyloid plaques, one of the pathogenic factors, but also excite neural activity, and stimulate a wider area of ​​the brain.

[0005] However, there are at least the following technical barriers to combining TMS with near-infrared light stimulation technology. For example, TMS can generate a magnetic induction intensity of 1-5T at the center of the coil, which will have a strong attraction for ferromagnetic materials, and the changing magnetic field will also generate eddy currents or heat in the metal. It is not suitable to place the irradiation unit with metal materials between the TMS coil and the subject's head. If the irradiation unit used in the near-infrared light stimulation device is placed on the outside of the coil (opposite to the wearing side), it will be blocked by the coil and cannot irradiate the head at all. If it is placed on the inside of the coil (wearing side), the thickness of the irradiation unit itself will increase the distance between the coil and the head, resulting in a significant reduction in the depth of TMS action, affecting the treatment effect. The existing TMS and near-infrared light stimulation devices have relatively single stimulation sites, and the stimulated brain volume is not wide enough. Summary of the invention

[0006] The present application aims to provide a transcranial optical magnetic neuromodulation device to coordinately perform optical magnetic modulation on the target brain area in the time domain and spatial domain, and can stimulate a wide range of brain volumes as needed, so that the distance between the magnetic stimulation coil and the head is appropriate during the optical magnetic modulation process, thereby ensuring the synergistic therapeutic effect of optical magnetic.

[0007] An embodiment of the present invention provides a transcranial optomagnetic neural regulation device, which includes: a magnetic stimulation module, which includes a magnetic stimulation coil for applying transcranial magnetic stimulation; a light stimulation module, which is arranged corresponding to the magnetic stimulation module, and the light stimulation module includes a light source part and a diffusion component, the light source part emits near-infrared light, the diffusion component is arranged on the wearing side of the magnetic stimulation coil, the diffusion component receives the near-infrared light from the light source part and diffuses the near-infrared light, and the diffused near-infrared light is emitted through the exit surface of the diffusion component to irradiate the user's head; wherein the light source part is arranged at a position where the magnetic field strength of the magnetic stimulation coil is less than a first threshold.

[0008] Compared with the prior art, the embodiments of the present application can achieve the following beneficial technical effects.

[0009] The present application provides a transcranial optical magnetic nerve regulation device, which sets a light stimulation module and a magnetic stimulation module correspondingly, and sets a diffusion component of the light stimulation module on the wearing side of the magnetic stimulation coil in the magnetic stimulation module, so that the relatively thin diffusion component is located between the magnetic stimulation coil and the head, effectively reducing the distance between the magnetic stimulation coil and the head, ensuring the depth of TMS action, thereby improving the therapeutic effect of TMS; the diffusion component receives near-infrared light from the light source part of the light stimulation module and diffuses the near-infrared light, and the diffused near-infrared light is emitted through the exit surface of the diffusion component to irradiate to the user's head, so that the near-infrared light emitted by the light source part is diffused by the diffusion component and irradiated to the user's head, covering most of the brain area of ​​the head as comprehensively as possible. After being used in conjunction with the magnetic stimulation coil, the stimulated brain volume is wide enough. At the same time, the light source part is set at a position where the magnetic field strength of the magnetic stimulation coil is less than the first threshold value, so that the interference between the optical stimulation module and the magnetic stimulation module is significantly reduced during use. The transcranial optical magnetic neural regulation device can have both TMS and near-infrared light irradiation capabilities, so as to achieve effective coordinated optical magnetic regulation of the target brain area in both time domain and space domain.

[0010] The transcranial optical magnetic neuromodulation device provided in the present application can simultaneously stimulate a sufficiently wide brain volume and deeper depths under the cerebral cortex through effective optical and magnetic synergy, thereby effectively improving the treatment effect. BRIEF DESCRIPTION OF THE DRAWINGS

[0011] In the drawings, which are not necessarily drawn to scale, the same reference numerals may describe similar parts in different views. The same reference numerals with letter suffixes or different letter suffixes may represent different instances of similar parts. The accompanying drawings generally illustrate various embodiments by way of example and not limitation, and together with the specification and claims, are used to illustrate the disclosed embodiments. When appropriate, the same reference numerals are used throughout the drawings to refer to the same or similar parts. Such embodiments are illustrative and are not intended to be exhaustive or exclusive embodiments of the present apparatus or method.

[0012] Figure 1 is a schematic structural diagram of a transcranial optical magnetic nerve regulation device according to an embodiment of the present invention; Figure 2 is a stereoscopic view of a transcranial optical magnetic nerve regulation device according to an embodiment of the present invention observed from the front; Figure 3 is a stereoscopic view of a magnetic stimulation module in a transcranial optical magnetic nerve regulation device according to an embodiment of the present invention, viewed from one angle; Figure 4 (a) is a distribution diagram of the magnetic field intensity of the figure-8 coil along the x-axis direction; Figure 4 (b) is a distribution diagram of the magnetic field intensity of the figure-8 coil along the y-axis direction; FIG5 (a) is a perspective view of a light stimulation module in a transcranial optical magnetic nerve regulation device according to an embodiment of the present invention; FIG5( b ) is a perspective view of a light stimulation module in a transcranial optical magnetic nerve regulation device according to another embodiment of the present invention; FIG5( c ) is a perspective view of a light stimulation module in a transcranial optical magnetic nerve regulation device according to another embodiment of the present invention; Figure 6 It is a cross-sectional view of a flat diffusion component in a transcranial optical magnetic neural regulation device according to an embodiment of the present invention.

[0013] The components indicated by the reference numerals in the figures are: 1-transcranial optical magnetic neural regulation device; 100-magnetic stimulation module; 101-magnetic stimulation coil; 102-shell; 200-optical stimulation module; 201-light source part; 202-diffusion component; 2021-main body; 2022-light guide point; 2023-exit surface; 2024-reflection part; 203-optical transmission component. DETAILED DESCRIPTION

[0014] In order to enable those skilled in the art to better understand the technical solution of the present invention, the present invention is described in detail below in conjunction with the accompanying drawings and specific embodiments. The embodiments of the present invention are further described in detail below in conjunction with the accompanying drawings and specific embodiments, but are not intended to limit the present invention.

[0015] The words "first", "second" and similar words used in the present invention do not indicate any order, quantity or importance, but are only used to distinguish different parts. The words "include" or "comprise" and similar words mean that the elements before the word include the elements listed after the word, and do not exclude the possibility of including other elements.

[0016] In the description of the present application, it should be understood that the orientation or positional relationship indicated by directional words such as "front", "back", "up", "down", "left", "right", "lateral", "vertical", "vertical", "horizontal", "top", "bottom", etc. is usually based on the orientation or positional relationship shown in the drawings, and is only for the convenience of describing the present application and simplifying the description. Unless otherwise specified, these directional words do not indicate or imply that the device or element referred to must have a specific orientation or be constructed and operated in a specific orientation, and therefore cannot be understood as limiting the scope of protection of the present invention; the directional words "inside" and "outside" refer to the inside and outside relative to the outline of each component itself.

[0017] All terms (including technical terms or scientific terms) used in the present invention have the same meanings as those understood by ordinary technicians in the field to which the present invention belongs, unless otherwise specifically defined. It should also be understood that terms defined in general dictionaries should be interpreted as having meanings consistent with their meanings in the context of the relevant technology, and should not be interpreted in an idealized or extremely formal sense, unless explicitly defined herein.

[0018] Technologies, methods, and equipment known to ordinary technicians in the relevant art may not be discussed in detail, but where appropriate, the technologies, methods, and equipment should be considered as part of the specification.

[0019] The preferred embodiments of the present invention are described below in conjunction with the accompanying drawings. It should be understood that the embodiments described herein are only used to illustrate and explain the present invention, and are not used to limit the present invention.

[0020] Both transcranial magnetic stimulation (TMS) technology and near-infrared light stimulation technology can regulate the function of the nervous system. The current TMS system mainly includes a coil system, an operation terminal and a host. The host is used to control the high-voltage energy storage capacitor to discharge to the coil assembly after charging, so that the coil assembly generates an induced magnetic field. The operation terminal is installed with a software system that allows the operator to set stimulation parameters, including but not limited to stimulation intensity, frequency, number of pulses, intermittent time and number of strings. Sometimes the software system also includes an information management system for logging in, storing and viewing user information, and automatically generating diagnosis and treatment reports. The coil system is used to generate an induced magnetic field. The magnetic stimulation coil 101 is formed by a conductive copper wire winding, including various configurations, such as circular, 8-shaped, double-conical, H-shaped, etc. The cooling mechanism can be liquid cooling and / or air cooling, which is used to exchange heat with the coil through a cooling fluid (liquid or gas) to provide sufficient cooling for it. The temperature sensor is set near the coil to detect the temperature of the adjacent area to ensure that the temperature is within an acceptable range to avoid harming the user. When TMS is used to stimulate the user's brain area, a magnetic induction intensity of 1-5T will be generated at the center of the magnetic stimulation coil 101, which will strongly attract ferromagnetic materials, and the changing magnetic field will also generate eddy currents or heat in the metal. Therefore, it is necessary to provide a transcranial optical magnetic nerve regulation device 1 that can combine the TMS system with the near-infrared light stimulation system and significantly reduce the interference between the two.

[0021] The present application embodiment provides a transcranial optical magnetic nerve regulation device 1, which can smoothly combine the TMS system with the near-infrared light stimulation system and significantly reduce the interference between the two. Figure 1-2As shown, the transcranial optical magnetic nerve regulation device 1 includes a magnetic stimulation module 100 and a light stimulation module 200. The magnetic stimulation module 100 includes a magnetic stimulation coil 101 to apply transcranial magnetic stimulation. The light stimulation module 200 is arranged corresponding to the magnetic stimulation module 100. The light stimulation module 200 includes a light source unit 201 and a diffusion component 202. The light source unit 201 emits near-infrared light. The diffusion component 202 is arranged on the wearing side of the magnetic stimulation coil 101, wherein the side of the magnetic stimulation coil 101 close to the user's head is the wearing side of the magnetic stimulation coil 101. The diffusion component 202 receives the near-infrared light from the light source unit 201 and diffuses the received near-infrared light. The diffused near-infrared light is emitted through the exit surface 2023 of the diffusion component 202 to irradiate the user's head. Preferably, the material of the diffusion component 202 is a light-transmitting material. The diffusion component 202 can be constructed to be free of ferromagnetic materials, that is, compatible with the application environment of high magnetic induction intensity.

[0022] In this configuration, the diffusion component 202, which is relatively thin and compatible with high magnetic induction intensity environments, is located between the magnetic stimulation coil 101 and the head, effectively reducing the distance between the magnetic stimulation coil 101 and the head, ensuring the depth of TMS action, ensuring the therapeutic effect of TMS, and the near-infrared light emitted by the light source part 201 is irradiated to a wide area of ​​the user's head through the diffusion effect of the diffusion component 202, so that the transcranial near-infrared light covers most of the brain area of ​​the head as comprehensively as possible. When used in conjunction with the magnetic stimulation coil 101, the stimulated brain volume is wide enough.

[0023] Further, the light source unit 201 is arranged at a position where the magnetic field strength of the magnetic stimulation coil 101 is less than the first threshold value, and the first threshold value is not more than 2T, so that the interference between the optical stimulation module 200 and the magnetic stimulation module 100 during use can be significantly reduced, and the interference includes the effect of the magnetic field on the ferromagnetic material in the light source unit 201 and the disturbance of the magnetic field by the ferromagnetic material in the light source unit 201. The transcranial optical magnetic neural regulation device 1 can have both TMS and near-infrared light irradiation capabilities, and effectively cooperate in performing optical magnetic regulation on the target brain area in both the time domain and the spatial domain. It can be understood that the light source unit 201 described herein is a device that directly emits near-infrared light, such as an LED component, a laser, etc., and is distinguished from a passive optical transmission component 203 that only transmits near-infrared light. Compared with an optical transmission component 203 such as an optical fiber or an optical device, as a device that directly emits near-infrared light, the light source unit 201 includes an electroluminescent device, which is more likely to include a ferromagnetic metal or a non-ferromagnetic metal. In some embodiments, even if the light source unit 201 itself does not contain metal, there is current in the cable connected thereto, so in this application the light source unit 201 is disposed at a position where the magnetic field strength of the magnetic stimulation coil 101 is less than the first threshold value to reduce interference between light and magnetism.

[0024] The transcranial photomagnetic neuromodulatory device 1 provided in the embodiment of the present application can simultaneously stimulate a sufficiently wide brain volume and a deeper depth under the cerebral cortex through effective photomagnetic synergy. Near-infrared light irradiation is mainly used to reduce the formation of β-amyloid protein plaques and reduce damage to the nervous system. Transcranial magnetic stimulation is mainly used to stimulate the cerebral cortex and peripheral nervous system, enhance nerve activity, and promote nerve repair. Photomagnetic synergy effectively improves the treatment effect.

[0025] In some embodiments, the magnetic stimulation module 100 further includes a housing 102 disposed outside the magnetic stimulation coil 101, and the diffusion component 202 is disposed on the wearing side of the housing 102, wherein the side of the housing 102 close to the user's head is the wearing side of the housing 102. Figure 2 , Figure 2 The middle shell 102 is not shown, and it can be understood that the shell 102 is arranged around the outer side of the magnetic stimulation coil 101, and the diffusion component 202 is arranged outside the shell 102 and is separated from the shell 102. When in use, the diffusion component 202 is first placed close to the user's head, and then the magnetic stimulation coil 101 or the shell 102 of the magnetic stimulation module 100 is placed close to the diffusion component 202. During treatment, the magnetic stimulation coil 101 or the shell 102 can be placed against the diffusion component 202, and the diffusion component 202 serves as a support between the magnetic stimulation coil 101 or the shell 102 and the user's head. In this way, the magnetic stimulation coil 101 is closer to the head, ensuring the depth of TMS action, thereby ensuring the therapeutic effect of TMS; alternatively, the magnetic stimulation coil 101 or the shell 102 can be spaced a certain distance from the diffusion component 202, such as no more than 20 mm. In this way, during the treatment, the magnetic stimulation coil 101 or the shell 102 will not press the diffusion component 202 tightly against the user's head, so that the user will not have a strong sense of confinement and oppression, and the use is more comfortable, and the user is more cooperative during the treatment process.

[0026] In other embodiments, see Figure 3, taking the magnetic stimulation coil 101 as an 8-shaped coil as an example, the shell 102 is arranged around the outside of the magnetic stimulation coil 101, and the diffusion component 202 is arranged outside the shell 102, and is located on the wearing side of the shell 102, and is arranged closely with the shell 102. The side of the diffusion component 202 away from the shell 102 is the exit surface 2023, and the near-infrared light is diffused by the diffusion component 202 and then emitted from the exit surface 2023 to irradiate the user's head. It can be understood that the shape of the diffusion component 202 can be adapted to the wearing side of the shell 102, such as the shell 102 surface of the circular, elliptical, and 8-shaped coil has a cavity, and the diffusion component 202 is also provided with a hole at the position corresponding to the cavity to adapt to the shell 102; the surface of the wearing side of the H-shaped or biconical shell 102 is not a plane or has an arc, and the diffusion component 202 is set to a shape consistent with the wearing side of the H-shaped or biconical shell 102 to improve the adaptability of the structural assembly. In some embodiments, the shape of the diffusion component 202 may not completely match the wearing side of the shell 102. For example, for a shell 102 with a cavity, the diffusion component 202 may not have a hole at the position corresponding to the cavity. Since the material of the diffusion component 202 does not affect the magnetic field strength generated by the magnetic stimulation coil 101, such a setting does not reduce the treatment effect. On the contrary, the irradiation area of ​​the diffusion component 202 is larger and the treatment effect is better. The shape and degree of adaptation of the diffusion component 202 are not specifically limited here, as long as it does not affect the magnetic stimulation coil 101 from applying transcranial magnetic stimulation to the user's head.

[0027] In some embodiments, the magnetic stimulation module 100 also includes a shell 102 disposed on the outside of the magnetic stimulation coil 101, a diffusion component 202 disposed on the wearing side of the shell 102, and the diffusion component 202 disposed in the shell 102. The shell 102 has a light-transmissive wearing surface, and the wearing surface is constructed as an exit surface 2023 of the diffusion component 202. In this way, the diffusion component 202 and the magnetic stimulation coil 101 share the shell 102, which can further reduce the distance between the magnetic stimulation coil 101 and the head and improve the treatment effect. At the same time, the diffusion component 202 and the magnetic stimulation coil 101 can share a set of cooling mechanisms, which saves materials and facilitates configuration, while improving the user's comfort and preventing the user from being burned by excessive temperature. Furthermore, by holding the TMS magnetic racket just above the target area of ​​the head, the operator can perform near-infrared light irradiation on the target area while performing transcranial magnetic stimulation on the target area.

[0028] The inventor of the present application has found through testing that the closer to the edge of the magnetic stimulation coil 101 in the horizontal direction and the farther away from the center position of the magnetic stimulation coil 101 in the vertical direction, the magnetic field strength will be significantly reduced. Taking the magnetic stimulation coil 101 as an 8-shaped coil as an example, refer to FIG4 (a) the distribution diagram of the magnetic field strength of the 8-shaped coil along the x-axis direction and FIG4 (b) the distribution diagram of the magnetic field strength of the 8-shaped coil along the y-axis direction. The coil D structure in FIG4 (a) and FIG4 (b) is specifically an inner diameter of 56 mm (per ring), an outer diameter of 87 mm, and a number of turns of 9 (*2). Circular coils, double-conical coils, and H-shaped coils all have similar situations, which will not be repeated here. Therefore, by setting the light source unit 201 to be far away from the center of the magnetic stimulation coil 101 both in the horizontal and vertical directions, and to be located at its edge or even more peripheral, the effect of the changing magnetic field generated by the magnetic stimulation coil 101 on the position of the light source unit 201 will be smaller, which not only significantly reduces the heat generation and ensures the stability of the working current of the light source unit 201, but also effectively suppresses the interference of the current of the light source unit 201 and its wires on the magnetic field of the magnetic stimulation coil 101.

[0029] In some embodiments, the magnetic stimulation coil 101 has a cavity, and the light source unit 201 and / or the optical transmission component 203 connected to the light source unit 201 can be arranged corresponding to the cavity, and the exit surface 2023 of the diffusion component 202 is arranged on the wearing side of the magnetic stimulation coil 101. The cavity provides sufficient layout space, and the optical transmission component 203 or the light source unit 201 that does not contain metal materials, or the shielding box that wraps the light source unit 201 containing ferromagnetic materials with non-ferromagnetic metal materials (such as aluminum) can be arranged corresponding to the cavity. In the latter way, at the spatial position where the light source unit 201 containing ferromagnetic materials is actually arranged, the magnetic field intensity of the magnetic stimulation coil 101 is still less than the first threshold.

[0030] Further, taking the magnetic stimulation coil 101 as a circular coil, there is a cavity in the middle of the circular coil, and the cavity can be used to simultaneously arrange the light source part 201 and the diffusion component 202, or the cavity can be used to simultaneously arrange the light transmission component 203 connected to the light source part 201 and the diffusion component 202, or the cavity can be used to simultaneously arrange the light source part 201, the light transmission component 203 connected to the light source part 201, and the diffusion component 202. In this case, the light source part 201 is arranged corresponding to the circumference of the cavity, such as the light source part 201 is arranged around the outer circumference of the diffusion component 202, and is also arranged on the inner circumference of the cavity, and the emission surface 2023 of the diffusion component 202 is arranged on the wearing side of the magnetic stimulation coil 101. Since the magnetic field intensity at the peripheral position of the cavity is relatively small (especially compared with the center of the cavity), the light source part 201 is arranged corresponding to the circumference of the cavity, which has a relatively small impact on the light source part 201 and the magnetic stimulation coil 101, and the spatial arrangement is reasonably utilized without affecting the use. The method of simultaneously arranging the light transmission component 203 and the diffusion component 202 using the cavity hole, or simultaneously arranging the light source unit 201, the light transmission component 203 and the diffusion component 202 using the cavity hole is similar to the above, and will not be repeated here.

[0031] In some embodiments, as shown in FIG5 (a), taking the magnetic stimulation coil 101 as a circular coil as an example, the circular coil has a cavity in the middle, the light source portion 201 (if it contains ferromagnetic metal, it can be magnetically shielded as needed, not shown in the figure) is arranged in the cavity of the circular coil, and the diffusion component 202 is located below the light source portion 201. At the same time, the diffusion component 202 is located on the wearing side of the magnetic stimulation coil 101, close to the magnetic stimulation coil 101, and the shape of the diffusion component 202 is adapted to the shape of the wearing side of the magnetic stimulation coil 101.

[0032] In some embodiments, as shown in FIG. 5( b ), the magnetic stimulation coil 101 is a circular coil as an example, and there is a cavity in the middle of the circular coil. The diffusion component 202 is located on the wearing side of the magnetic stimulation coil 101 and is arranged close to the magnetic stimulation coil 101. The shape of the diffusion component 202 is adapted to the shape of the wearing side of the magnetic stimulation coil 101. The diffusion component 202 is provided with a hole at the position corresponding to the cavity of the circular coil. The optical transmission component 203 connected to the light source unit 201 passes through the cavity of the circular coil and enters the hole of the diffusion component 202 to connect with the diffusion component 202 to transmit the near-infrared light from the distant light source unit 201. In this arrangement, the optical transmission component 203 can be fully utilized to arrange the position of the cavity. Since the light source unit 201 is arranged far away from the magnetic stimulation coil 101, the optical transmission component 203, such as an optical fiber, does not contain metal, which greatly increases the space utilization without affecting normal use.

[0033] In some embodiments, as shown in FIG5 (c), taking the magnetic stimulation coil 101 as a circular coil as an example, the circular coil has a cavity in the middle, the diffusion component 202 is located on the wearing side of the magnetic stimulation coil 101, and is arranged close to the magnetic stimulation coil 101. The shape of the diffusion component 202 is adapted to the shape of the wearing side of the magnetic stimulation coil 101. The diffusion component 202 is provided with a hole at the position corresponding to the circular coil cavity. The light source unit 201 is located at the inner periphery of the diffusion component 202 close to the hole and the outer periphery away from the hole. Since the inner periphery of the diffusion component 202 is close to the cavity position of the magnetic stimulation coil 101 and the outer periphery of the diffusion component 202 is away from the center of the magnetic stimulation coil 101 and is located at its edge, the light source unit 201 is located at the inner and outer peripheries of the diffusion component 202 where the magnetic field strength is relatively small, and may not affect the normal use of the magnetic stimulation module 100 and the light stimulation module 200. When the light source unit 201 is located at the inner periphery of the diffusion component 202, the cable connected to the light source unit 201 can be arranged through the cavity of the magnetic stimulation coil 101, so as to make full use of the space.

[0034] In some embodiments, the light source portion 201 includes an LED component, which is disposed on the inner periphery and / or outer periphery of the diffusion component 202, and the LED component is constructed to not contain ferromagnetic materials. Since the diffusion component 202 is disposed on the wearing side of the magnetic stimulation coil 101 and is used to diffuse near-infrared light, the positions of the diffusion component 202 and the magnetic stimulation coil 101 need to be set correspondingly to achieve effective coordinated photomagnetic regulation of the target brain area in both the time domain and the spatial domain. The diffusion component 202 will be located at a location with a strong magnetic field strength. When the light source portion 201 is an LED component, the LED component cannot contain ferromagnetic materials to avoid the changing magnetic field from generating eddy currents or heat in the metal.

[0035] Further, when the magnetic stimulation coil 101 has a cavity, the shape of the diffusion component 202 is adapted to the shape of the wearing side of the magnetic stimulation coil 101, and there is also a hole in the middle. The LED component can be arranged on the inner periphery of the diffusion component 202, or on the outer periphery of the diffusion component 202, or on the inner and outer peripheries of the diffusion component 202 at the same time. Since the magnetic field strength at the cavity position and the outer periphery of the magnetic stimulation coil 101 is relatively small, the position where the LED component is located at the inner and outer peripheries of the diffusion component 202 is located at a relatively small magnetic field strength, which may not affect the normal use of the magnetic stimulation module 100 and the light stimulation module 200. Further, the LED component is connected to a cable, and the material of the cable is copper wire, so the cable needs to have a shielding layer, and the shielding layer is driven by a voltage follower, rather than directly grounded, to suppress the common-mode interference signal brought by the strong magnetic field to the wire. The configuration cost of the LED component is low, and the control difficulty and safety are better than the introduction of laser. The control module in the host can be implemented by a processor, and the LED drive module can be an LED drive circuit. The processor can control the LED drive circuit to drive the LED component to emit near-infrared light.

[0036] In some embodiments, the light source unit 201 includes a light emitting element, and the light stimulation module 200 also includes an optical transmission element 203 connected to the light emitting element. The light emitting element is constructed to contain ferromagnetic material and is away from the wearing side of the magnetic stimulation coil 101. The optical transmission element 203 is optically coupled to the diffusion component 202. The light emitting element includes a device that directly emits a light source, such as a laser, an LED lamp, and is an active device, and contains ferromagnetic material; the optical transmission element 203 includes an optical fiber, etc., which is used to guide light and transmit the light emitted by the light emitting element. The light emitting element needs to be away from the wearing side of the magnetic stimulation coil 101 and away from the center of the magnetic field. Preferably, the light emitting element is located at a position where the magnetic field intensity is close to 0. Since there is no ferromagnetic material in the optical transmission element 203, it can be located at any position of the magnetic field intensity. Its position is not specifically limited here. The optical transmission element 203 can be optically coupled to the diffusion component 202 in various ways, for example, but not limited to being set in the diffusion component 202.

[0037] In some embodiments, Figure 6As shown, it is a cross-sectional view of a flat diffusion component 202. Taking the light source part 201 as an LED component as an example, the LED component is arranged on the periphery of the diffusion component 202. There are other ways to arrange the LED component, which have been listed above and will not be repeated here. The diffusion component 202 includes a main body 2021. A plurality of light guide points 2022 are arranged on one side of the main body 2021 that is arranged opposite to the exit surface 2023 of the diffusion component 202. The near-infrared light received by the diffusion component 202 is diffusely reflected by each light guide point 2022 and then emitted from the exit surface 2023 to irradiate the user's head. The exit surface 2023 of the diffusion component 202 corresponds to the side of the light stimulation module 200 to be worn on the head. The diffusion component 202 can be rigid or flexible, one-piece or split, flat or curved, as long as it can fit the user's head. The form of the diffusion component 202 is not specifically limited here. The LED component forms a good optical coupling with the diffusion component 202, and the emitted near-infrared light is incident into the body 2021. The near-infrared light received by the body 2021 is diffusely reflected in various directions by each light guide point 2022 and then emitted from the exit surface 2023 to irradiate the user's head. In this way, the near-infrared light emitted by the LED component can be converted into a surface light source and emitted from the exit surface 2023, so that the near-infrared light can stimulate a sufficiently wide brain volume with a relatively uniform dose.

[0038] Furthermore, the manufacturing process of the light guide point 2022 adopts any one of laser engraving, chemical etching, V-cut, and UV screen printing.

[0039] Furthermore, the main material of the body 2021 of the diffusion component 202 can be acrylic (PMMA) or other materials with good light transmittance, such as polycarbonate (PC), MS board (a copolymer synthesized by extracting 50% polymethyl methacrylate (PMMA) and 50% styrene (PS) as main raw materials), etc.

[0040] Furthermore, the body 2021 can also be made of flexible materials, such as but not limited to PVC transparent soft glass, transparent polyimide (CPI), etc. In some embodiments, the flexible diffusion component 202 can closely fit the different contours of the individual's head, increasing the radiation efficiency of the emitted near-infrared light to the head. In other words, the diffusion component 202 actually also serves as an adaptation mechanism between the magnetic stimulation coil 101 and the head, helping the magnetic stimulation coil 101 to firmly and comfortably fit the subject's head, and reducing optical refraction and loss in the gap between the diffusion component 202 and the head.

[0041] Furthermore, the light guide points 2022 are arranged unevenly, and the light guide points 2022 of different densities and sizes can make the emission surface 2023 of the diffusion component 202 emit light evenly.

[0042] Furthermore, the diffusion component 202 also includes a reflective portion 2024, which is arranged opposite to the exit surface 2023 and is located on the side of the light guide point 2022 away from the exit surface 2023. The reflective portion 2024 is located on the opposite side of the exit surface 2023, below the light guide point 2022, and reflects the near-infrared light irradiated to the reflective portion 2024 back into the body 2021 to improve the efficiency of light use. In addition to using LED components, near-infrared laser LEDs can also be used, or optical fibers can be installed to guide near-infrared light from the outside to enter the body 2021, which will not be described in detail here.

[0043] In some embodiments, the reflective portion 2024 is made of a non-metallic material with high light reflectivity or a non-ferromagnetic metal material. During use, the reflective portion 2024 of the diffusion component 202 is close to the magnetic stimulation coil 101. The reflective portion 2024 can be made of non-metal to reduce the heat generated by the induced current of the changing magnetic field of the magnetic stimulation coil 101; or, the reflective portion 2024 can also be made of non-ferromagnetic metal materials, such as copper foil, silver foil, etc., to avoid disturbing the magnetic field of the magnetic stimulation coil 101; the reflective portion 2024 as a metal will generate heat, and the heat generated can be cooled together with the magnetic stimulation coil 101 by liquid cooling or air cooling. In some embodiments, the transcranial optical magnetic nerve regulation device 1 also includes a cooling mechanism, the magnetic stimulation coil 101 is arranged in a cooling medium supplied by the cooling mechanism, and the reflective portion 2024 is close to the magnetic stimulation coil 101, allowing the magnetic stimulation coil 101 to take away the heat, and the heat of the magnetic stimulation coil 101 is then taken away by the cooling medium. Alternatively, the reflector 2024 may also be placed in a cooling medium, and share the cooling medium and cooling circuit with the magnetic stimulation coil 101. In this way, a set of cooling mechanisms is used to cool the magnetic stimulation coil 101 and the light stimulation module 200 at the same time, which can reasonably utilize resources.

[0044] Furthermore, the main body 2021 of the diffusion component 202 can be made of a thermal insulator, such as PC and CPI, and the exit surface 2023 is close to the subject's head, so that the heat generated by the magnetic stimulation coil 101 and the reflection part 2024 will not be transferred to the user's head, thereby avoiding scalding the user.

[0045] In some embodiments, the shape of the magnetic stimulation coil 101 is selected from one of circular, elliptical, figure-8, H-shaped or biconical. Preferably, the magnetic stimulation coil 101 is an H-shaped coil so that it can act on a deeper and wider target area.

[0046] In some embodiments, the ratio of the wearing side of the magnetic stimulation coil 101 blocked by the exit surface 2023 of the diffusion component 202 is greater than a predetermined threshold. Since the materials of each part of the body 2021 of the diffusion component 202 are non-metallic materials or non-ferromagnetic metal materials, the diffusion component 202 is located in a magnetic field environment and does not affect the effect of optical and magnetic synergy. Furthermore, the predetermined threshold is not less than 10%, preferably, the predetermined threshold is 50%, 70% or 100%. The greater the ratio of the wearing side of the magnetic stimulation coil 101 blocked by the exit surface 2023 of the diffusion component 202, the better the effect of optical and magnetic synergistic stimulation of the relevant target area, which can achieve a certain stimulation area and a deeper stimulation depth, effectively improving the treatment effect.

[0047] In some embodiments, the transcranial optical magnetic nerve regulation device 1 further includes a control module, which is connected to the magnetic stimulation module 100 and the optical stimulation module 200 respectively, and controls the optical stimulation module 200 and the magnetic stimulation module 100 to work sequentially or simultaneously in time division. For example, when the LED component is used, the optical stimulation module 200 can be turned off when the magnetic stimulation module 100 is working, and the magnetic stimulation module 100 does not work when the optical stimulation module 200 is turned on. In this way, by controlling the optical stimulation module 200 and the magnetic stimulation module 100 to work sequentially in time division, the interference between the optical and magnetic synergistic use is reduced, and the safety and stability during use are further improved. For another example, if the light emitting element (including ferromagnetic metal) emits near-infrared light, and the optical transmission element 203 guides light, since the light emitting element is far away from the magnetic field, it will not be disturbed by the magnetic field, and the magnetic stimulation module 100 will not be disturbed by the metal of the light emitting element, it is possible to achieve the simultaneous operation of the magnetic stimulation module 100 and the optical stimulation module 200, deepen the stimulation depth, and effectively improve the treatment effect.

[0048] In some embodiments, the control module is further configured to: send a first control signal to the light stimulation module 200 to control the light stimulation module 200 to start, and after the light stimulation module 200 starts for a preset time, send a second control signal to the magnetic stimulation module 100 to control the magnetic stimulation module 100 to start. After controlling the light stimulation module 200 to start for a certain time, the near-infrared light stimulation may put the neurons in a state that is easier to be activated. In this case, controlling the magnetic stimulation module 100 to start can make the effect of TMS stimulation more significant, greatly improving the therapeutic effect of the target area. Among them, the preset time can be set according to the needs of treating different diseases, which can be 30s, 60s, 90s, 120s, etc., and is not specifically limited here.

[0049] In some embodiments, the thickness of the diffusion component 202 does not exceed 10 mm. Furthermore, the thickness of the diffusion component 202 can be 3 mm-10 mm, or even 3-7 mm, or even 3 mm-6 mm, so that when performing transcranial magnetic stimulation, the stimulation depth can reach the cerebral cortex, or even deeper depths of the cerebral cortex, such as 2 cm, 3 cm or even deeper depths. The stimulation depth of a single H-type coil is greater than 6 cm, which can effectively stimulate deep brain nuclei. At a stimulation intensity of 120% MT, the H coil can still induce a superthreshold electric field 1.8 cm below the cortex. The effective stimulation depth of the double-cone coil can reach 6 cm, which can stimulate deeper brain areas other than the cerebral cortex, such as the cerebellum, anterior cingulate gyrus, orbitofrontal lobe, etc. The double-cone coil can generate current 4-5 cm below the intersection of the two coils, so the stimulation site is deeper. Since our diffusion component 202 is very thin and fully utilizes the original internal space of the magnetic stimulation coils 101 to accommodate the light source part 201 and / or the diffusion component 202 of the light stimulation module 200, the intensity of magnetic stimulation can still act deep into the brain during transcranial optical magnetic stimulation.

[0050] In some embodiments, for users with dark and thick hair, the transcranial optical magnetic nerve regulation device 1 can also be used in conjunction with a light guide comb. When the user wears the light guide comb, they can spread their hair to form an optical path for near-infrared light (for example, the light-transmitting retaining part of the light guide comb - the scalp with sparse hair and fully exposed under the light-transmitting retaining part - the skull under the scalp), and the light transmittance can be increased by 20-30%. At the same time, the light guide comb provides thermal insulation and physical isolation, and also provides support for the diffusion component 202, so that heat generation is less likely to be transferred to the scalp.

[0051] In some embodiments, the light guide comb can be integrated into the diffusion component 202. When wearing, the light guide comb is directly worn, the user's hair is pushed aside from the front, and the diffusion component 202 is positioned. Then the magnetic stimulation coil 101 is worn. The magnetic stimulation coil 101 is positioned relative to the subject's head, which can perform optical and magnetic coordinated regulation, making it convenient to use while improving the treatment effect.

[0052] The present invention provides a transcranial optical magnetic nerve regulation device 1, in which an optical stimulation module 200 and a magnetic stimulation module 100 are correspondingly arranged, and a diffusion component 202 of the optical stimulation module 200 is arranged on the wearing side of a magnetic stimulation coil 101 in the magnetic stimulation module 100, so that a relatively thin diffusion component 202 is located between the magnetic stimulation coil 101 and the head, effectively reducing the distance between the magnetic stimulation coil 101 and the head, ensuring the depth of TMS action, and thus improving the therapeutic effect of TMS; the diffusion component 202 receives near-infrared light from a light source part 201 in the optical stimulation module 200 and diffuses the near-infrared light, and the diffused near-infrared light is emitted through the diffusion component 202 The near-infrared light emitted by the light source unit 201 is emitted from the surface 2023 to irradiate the user's head, so that the near-infrared light irradiated to the user's head by the diffusion effect of the diffusion component 202 covers most of the brain area of ​​the head as comprehensively as possible. After being used in conjunction with the magnetic stimulation coil 101, the stimulated brain volume is wide enough; at the same time, the light source unit 201 is set at a position where the magnetic field strength of the magnetic stimulation coil 101 is less than the first threshold value, so that the interference between the optical stimulation module 200 and the magnetic stimulation module 100 is significantly reduced during use. The transcranial optical magnetic neural regulation device 1 can have both TMS and near-infrared light irradiation capabilities, so as to achieve effective and coordinated optical magnetic regulation of the target brain area in both time domain and space domain.

[0053] The transcranial optical magnetic neuromodulatory device 1 provided in the present application can simultaneously stimulate a sufficiently wide brain volume and deeper depths under the cerebral cortex through effective optical and magnetic synergy, thereby effectively improving the treatment effect.

[0054] In addition, although exemplary embodiments have been described herein, the scope includes any and all embodiments based on the present invention with equivalent elements, modifications, omissions, combinations (e.g., various embodiments intersecting schemes), adaptations or changes. The elements in the claims will be interpreted broadly based on the language adopted in the claims, and are not limited to the examples described in this specification or during the implementation of this application, and the examples will be interpreted as non-exclusive. Therefore, this specification and examples are intended to be considered as examples only, and the true scope and spirit are indicated by the appended claims and the full scope of their equivalents.

[0055] The above description is intended to be illustrative rather than restrictive. For example, the above examples (or one or more of them) can be used in combination with each other. For example, a person of ordinary skill in the art can use other embodiments when reading the above description. In addition, in the above-mentioned specific embodiments, various features can be grouped together to simplify the present invention. This should not be interpreted as an intention that a disclosed feature that does not require protection is necessary for any claim. On the contrary, the subject matter of the present invention may be less than all the features of a specific disclosed embodiment. Thus, the attached claims are incorporated into the specific embodiments as examples or embodiments, wherein each claim is independently used as a separate embodiment, and it is considered that these embodiments can be combined with each other in various combinations or arrangements. The scope of the present invention should be determined with reference to the attached claims and the full scope of equivalent forms granted by these claims.

[0056] The above embodiments are only exemplary embodiments of the present invention and are not intended to limit the present invention. The protection scope of the present invention is defined by the claims. Those skilled in the art may make various modifications or equivalent substitutions to the present invention within the essence and protection scope of the present invention, and such modifications or equivalent substitutions shall also be deemed to fall within the protection scope of the present invention.

Claims

1. A transcranial optical magnetic nerve regulation device, characterized in that: The transcranial optical magnetic nerve regulation device comprises: a magnetic stimulation module including a magnetic stimulation coil to apply transcranial magnetic stimulation; A light stimulation module is arranged corresponding to the magnetic stimulation module, the light stimulation module includes a light source unit and a diffusion component, the light source unit emits near-infrared light, the diffusion component is arranged on the wearing side of the magnetic stimulation coil, the diffusion component receives the near-infrared light from the light source unit and diffuses the near-infrared light, and the diffused near-infrared light is emitted through the emission surface of the diffusion component to irradiate the user's head; wherein, The light source unit is disposed at a position where the magnetic field intensity of the magnetic stimulation coil is less than a first threshold value.

2. The transcranial optical magnetic nerve regulation device according to claim 1, characterized in that: The magnetic stimulation module further includes a shell disposed outside the magnetic stimulation coil, the diffusion component is disposed on the wearing side of the shell, and the diffusion component is constructed in one of the following ways: The diffusion component is arranged outside the shell, and is separated from the shell or arranged closely to the shell; The diffusion component is arranged in the shell, and the shell has a light-transmissive wearing surface, and the wearing surface is constructed as an exit surface of the diffusion component.

3. The transcranial optical magnetic nerve regulation device according to claim 1, characterized in that: The magnetic stimulation coil has a cavity, the light source part and / or the optical transmission component connected to the light source part is arranged corresponding to the cavity, and the exit surface of the diffusion component is arranged on the wearing side of the magnetic stimulation coil.

4. The transcranial optical magnetic nerve regulation device according to claim 1, characterized in that: The light source portion includes an LED component, the LED component is disposed at an inner periphery and / or an outer periphery of the diffusion component, and the LED component is configured to not include a ferromagnetic material.

5. The transcranial optical magnetic nerve regulation device according to claim 1, characterized in that: The light source portion includes a light emitting element, and the light stimulation module also includes a light transmission element connected to the light emitting element. The light emitting element is constructed to contain ferromagnetic material and is away from the wearing side of the magnetic stimulation coil. The light transmission element is arranged in the diffusion component.

6. The transcranial optical magnetic nerve regulation device according to any one of claims 1 to 5, characterized in that: The diffusion component includes a main body, and a plurality of light guide points are arranged on one side of the main body opposite to the exit surface of the diffusion component. The near-infrared light received by the diffusion component is diffusely reflected by each light guide point and then emitted from the exit surface to irradiate the user's head.

7. The transcranial optical magnetic nerve regulation device according to claim 6, characterized in that: The light guide points are arranged unevenly.

8. The transcranial optical magnetic nerve regulation device according to claim 6, characterized in that: The diffusion component further includes a reflection portion, which is arranged opposite to the emitting surface and is located on a side of the light guide point away from the emitting surface.

9. The transcranial optical magnetic nerve regulation device according to any one of claims 1 to 5, characterized in that: The shape of the magnetic stimulation coil is selected from one of a circular shape, an elliptical shape, an 8-shaped shape, an H-shaped shape or a double cone shape.

10. The transcranial optical magnetic nerve regulation device according to any one of claims 1 to 5, characterized in that: The ratio of the wearing side of the magnetic stimulation coil being blocked by the exit surface of the diffusion component is greater than a predetermined threshold.

11. The transcranial optical magnetic nerve regulation device according to claim 6, characterized in that: The manufacturing process of the light guide point adopts any one of laser engraving, chemical etching, V-cut and UV screen printing.

12. The transcranial optical magnetic nerve regulation device according to claim 8, characterized in that: The transcranial optical magnetic nerve regulation device also includes a cooling mechanism, the magnetic stimulation coil is arranged in a cooling medium supplied by the cooling mechanism, and the reflecting part is close to the magnetic stimulation coil.

13. The transcranial optical magnetic nerve regulation device according to claim 8, characterized in that: The reflecting part is made of a non-metallic material with high light reflectivity or a non-ferromagnetic metal material.

14. The transcranial optical magnetic nerve regulation device according to any one of claims 1 to 5, characterized in that: At least a portion of the diffusion component is made of a flexible material to adapt to the contour of the user's head.

15. The transcranial optical magnetic nerve regulation device according to any one of claims 1 to 5, characterized in that: The transcranial optomagnetic nerve regulation device also includes a control module, which is connected to the magnetic stimulation module and the optical stimulation module respectively, and controls the optical stimulation module and the magnetic stimulation module to work sequentially or simultaneously in a time-sharing manner.

16. The transcranial optical magnetic nerve regulation device according to claim 15, characterized in that: in, The control module is further configured to: A first control signal is sent to the optical stimulation module to control the optical stimulation module to start, and after the optical stimulation module is started for a preset time, a second control signal is sent to the magnetic stimulation module to control the magnetic stimulation module to start.

17. The transcranial optical magnetic nerve regulation device according to any one of claims 1 to 5, characterized in that: The thickness of the diffusion component does not exceed 10 mm.

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