Transcranial magnetoencephalography neuromodulation device

Abstract

The application provides a transcranial photomagnetic neuromodulation device, which comprises a magnetic stimulation module including a magnetic stimulation coil for applying transcranial magnetic stimulation, and a light stimulation module corresponding to the magnetic stimulation module, wherein 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; 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 through the exit surface of the diffusion assembly to irradiate the head of a user; and the light source part is arranged at a position where the magnetic field intensity of the magnetic stimulation coil is less than a first threshold value. When the device is used, the interference between the light stimulation module and the magnetic stimulation module is significantly reduced, the light and magnetic stimulation can effectively cooperate to perform photomagnetic regulation on the target brain area in the time domain and the spatial domain, a wide brain volume and a deeper depth under the cerebral cortex can be stimulated, and the treatment effect is effectively improved.

Description

TECHNICAL FIELD

[0001] The present application relates to the technical field of medical devices, in particular to a transcranial nerve regulation device, and more particularly to a transcranial photo-magnetic nerve regulation device. BACKGROUND

[0002] Transcranial magnetic stimulation (TMS) is a painless and non-invasive physical treatment method. A high-voltage capacitor in a stimulation generator generates a high-voltage current to act on a magnetic stimulation coil. A time-varying magnetic field generated in the coil penetrates the skull to stimulate the cerebral cortex and peripheral nerves, generate an induced current, change the action point of nerve cells, affect neurotransmitter metabolism and neural electrical activity, and thus trigger 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 brain blood flow and blood oxygen levels, promoting the release of neurotransmitters in the brain, stimulating the secretion of neurotrophic factors, and inducing neural network oscillation. Using TMS stimulation and its after-effects, the nervous system can be functionally regulated. TMS has been applied in various aspects, such as neuropsychology (depression, schizophrenia), rehabilitation, and pediatrics (cerebral palsy, autism, etc.). Some studies have shown that TMS stimulation can also have a certain therapeutic effect on Alzheimer's disease (AD) or Mild Cognitive Impairment (MCI).

[0003] Generally, the stimulation depth of a magnetic stimulation coil is shallow, only 1.5-3 cm. Although it can be indirectly transmitted to a remote site through the connection of the neural network in the stimulated area, or through improved stimulation coils such as double-cone coils and H-shaped coils, the stimulated brain volume is still not extensive enough.

[0004] Near-infrared light stimulation devices are also used to treat AD or MCI. They can trigger a series of physiological and biochemical reactions by irradiating the brain with an appropriate dose of near-infrared light. The 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 known that AD is a whole-brain disease and also has a target site in the brain functional network. If TMS and near-infrared light stimulation are used together to treat AD or MCI, it can not only remove the deposition of β-amyloid plaque, one of the pathogenic factors, but also excite neural activity, and the stimulated brain volume is more extensive.

[0005] However, there are at least the following technical obstacles in combining TMS with near-infrared light stimulation technology, such as: TMS can generate a magnetic induction intensity of 1-5T at the center position of the coil, which can produce strong attraction to ferromagnetic materials, and the changing magnetic field can also generate eddy current or heat in the metal, which is not suitable for placing the irradiation unit with metal materials between the TMS coil and the head of the subject; if the irradiation unit of the near-infrared light stimulation device is placed outside the coil (on the opposite side of the wearing side), it will be blocked by the coil and cannot irradiate the head at all, and if it is placed inside the coil (on the wearing side), the thickness of the irradiation unit itself will also increase the distance between the coil and the head, resulting in a significant reduction in the depth of action of TMS, affecting the treatment effect; the existing TMS and near-infrared light stimulation devices have a single stimulation site, and the stimulated brain volume is not extensive enough. SUMMARY

[0006] The present application aims to provide a transcranial photomagnetic neuromodulation device to perform photomagnetic modulation on the target brain region in time and space, and to stimulate a wide brain volume as needed, so that the distance between the magnetic stimulation coil and the head during photomagnetic modulation is appropriate, ensuring the synergistic treatment effect of photomagnetic modulation.

[0007] The transcranial photomagnetic neuromodulation device provided by the embodiment of the present application comprises: a magnetic stimulation module comprising a magnetic stimulation coil for applying transcranial magnetic stimulation; and a light stimulation module corresponding to the magnetic stimulation module, wherein the light stimulation module comprises a light source part and a diffusion assembly, the light source part emits near-infrared light, and the diffusion assembly is arranged on the wearing side of the magnetic stimulation coil, receives the near-infrared light from the light source part, and diffuses the near-infrared light, the diffused near-infrared light is emitted through the exit surface of the diffusion assembly to irradiate the head of the user, and the light source part is arranged at a position where the magnetic field intensity of the magnetic stimulation coil is less than a first threshold value.

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

[0009] The application provides a transcranial photomagnetic neuromodulation device, which corresponds the light stimulation module and the magnetic stimulation module, and sets the diffusion assembly 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 assembly is located between the magnetic stimulation coil and the head, effectively reducing the distance between the magnetic stimulation coil and the head, ensuring the action depth of TMS, thereby improving the treatment effect of TMS; the diffusion assembly receives the near-infrared light from the light source part in the light stimulation module and diffuses the near-infrared light, and the diffused near-infrared light is emitted through the emission surface of the diffusion assembly to irradiate the head of the user, so that the near-infrared light emitted by the light source part irradiates the head of the user through the diffusion effect of the diffusion assembly, and the near-infrared light covers most of the brain regions of the head as much as possible, and after being used with the magnetic stimulation coil, the stimulated brain volume is wide enough; meanwhile, the light source part is arranged at a position where the magnetic field intensity of the magnetic stimulation coil is less than a first threshold value, so that the interference between the light stimulation module and the magnetic stimulation module is significantly reduced during use, and the transcranial photomagnetic neuromodulation device can have the abilities of TMS and near-infrared light irradiation, and effectively cooperates with the target brain region in the time domain and the space domain to perform photomagnetic regulation.

[0010] The transcranial photomagnetic neuromodulation device provided by the application can effectively stimulate a wide brain volume and a deeper depth under the cerebral cortex at the same time through effective light-magnetic cooperation, and effectively improve the treatment effect. BRIEF DESCRIPTION OF DRAWINGS

[0011] In the drawings, which are not necessarily drawn to scale, like numerals can describe similar components in different views. Like numerals having different letter suffixes can represent different instances of similar components. The drawings illustrate generally, by way of example, various embodiments discussed herein, and are not intended to limit the disclosure to the embodiments depicted. The same reference numerals in different drawings can identify the same or similar elements. Such embodiments are examples only, and are not intended to be exhaustive or limiting of the present devices and methods.

[0012] Figure 1 is a structural schematic diagram of a transcranial photomagnetic neuromodulation device according to an embodiment of the application;

[0013] Figure 2 is a perspective view of a transcranial photomagnetic neuromodulation device according to an embodiment of the application, viewed from the front;

[0014] Figure 3 is a perspective view of a magnetic stimulation module in a transcranial photomagnetic neuromodulation device according to an embodiment of the application, viewed from an angle;

[0015] FIG. 4(a) is a distribution diagram of the magnetic field intensity of an 8-shaped coil along the x-axis direction;

[0016] Fig. 4(b) is a graph showing the distribution of the magnetic field strength of the 8-shaped coil along the y-axis direction;

[0017] Fig. 5(a) is a perspective view of a light stimulation module in a transcranial magneto-optical neuro-modulation device according to an embodiment of the present application;

[0018] Fig. 5(b) is a perspective view of a light stimulation module in a transcranial magneto-optical neuro-modulation device according to another embodiment of the present application;

[0019] Fig. 5(c) is a perspective view of a light stimulation module in a transcranial magneto-optical neuro-modulation device according to another embodiment of the present application;

[0020] Figure 6 Fig. 6 is a sectional view of a flat diffusion assembly in a transcranial magneto-optical neuro-modulation device according to an embodiment of the present application.

[0021] The components denoted by the reference numerals in the drawings are as follows:

[0022] 1 - transcranial magneto-optical neuro-modulation device; 100 - magnetic stimulation module; 101 - magnetic stimulation coil; 102 - housing; 200 - light stimulation module; 201 - light source portion; 202 - diffusion assembly; 2021 - body; 2022 - light guide point; 2023 - exit surface; 2024 - reflection portion; 203 - light transmission member. DETAILED DESCRIPTION

[0023] In order for those skilled in the art to better understand the technical solutions of the present application, the present application will be described in detail below in conjunction with the drawings and specific embodiments. The embodiments of the present application will be further described in detail below in conjunction with the drawings and specific embodiments, but are not intended to limit the present application.

[0024] The terms "first", "second", and similar terms used in the present application do not indicate any order, number, or importance, but are only used to distinguish different parts. The terms "comprise" or "include" and similar terms mean that the elements before the terms encompass the elements listed after the terms, and do not exclude the possibility of also encompassing other elements.

[0025] In the description of the present application, it should be understood that the orientation words such as "front", "back", "up", "down", "left", "right", "transverse", "vertical", "vertical", "horizontal", and "top", "bottom", and the like indicated orientation or position relationship are generally based on the orientation or position relationship shown in the drawings, and are only for the convenience of describing the present application and simplifying the description, without the opposite description, these orientation words do not indicate and imply that the indicated device or element must have a particular orientation or be constructed and operated in a particular orientation, therefore it cannot be understood as a limitation on the scope of protection of the present application; the orientation words "inner", "outer" refer to the inner and outer relative to the contour of each component.

[0026] All terms used in this invention (including technical or scientific terms) have the same meaning as understood by one of ordinary skill in the art to which this invention pertains, 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 art, and not as idealized or highly formalized, unless expressly defined herein.

[0027] Techniques, methods, and equipment known to those skilled in the art may not be discussed in detail, but where appropriate, such techniques, methods, and equipment should be considered part of the specification.

[0028] The preferred embodiments of the present invention will be described below with reference to the accompanying drawings. It should be understood that the embodiments described herein are for illustration and explanation only and are not intended to limit the present invention.

[0029] Transcranial magnetic stimulation (TMS) and near-infrared light stimulation (NIRS) technologies can both modulate the nervous system. Current TMS systems primarily consist of a coil system, an operating terminal, and a host unit. The host unit controls the charging of a high-voltage energy storage capacitor, which then discharges to the coil assembly, generating an induced magnetic field. The operating terminal is equipped with software that allows the operator to set stimulation parameters, including but not limited to stimulation intensity, frequency, number of pulses, interval time, and number of pulses. Sometimes, the software system also includes an information management system for logging, storing, and viewing user information and automatically generating treatment reports. The coil system generates the induced magnetic field. The magnetic stimulation coil 101 is formed by winding conductive copper wire and includes various configurations, such as circular, figure-eight, biconical, and H-shaped. The cooling mechanism can employ liquid cooling and / or gas cooling to exchange heat with the coil via a cooled fluid (liquid or gas), providing adequate cooling. Temperature sensors are placed near the coil to detect the temperature in the adjacent area, ensuring the temperature remains within an acceptable range to avoid harm to the user. When TMS stimulation is applied to the user's brain region, a magnetic induction intensity of 1-5T is generated at the center of the magnetic stimulation coil 101. This induction strongly attracts ferromagnetic materials, and the changing magnetic field also generates eddy currents or heat in metals. Therefore, there is a need for a transcranial photomagnetic neuromodulation device 1 that can combine a TMS system with a near-infrared photostimulation system while significantly reducing interference between the two.

[0030] This application provides a transcranial photomagnetic neuromodulation device 1, which can smoothly connect a TMS system and a near-infrared light stimulation system with significantly reduced interference between the two. For example... Figures 1-2As shown, the transcranial magneto-optical neuromodulation device 1 comprises a magnetic stimulation module 100 and an optical stimulation module 200. The magnetic stimulation module 100 comprises a magnetic stimulation coil 101 to apply transcranial magnetic stimulation. The optical stimulation module 200 is arranged corresponding to the magnetic stimulation module 100. The optical stimulation module 200 comprises a light source part 201 and a diffusion assembly 202. The light source part 201 emits near-infrared light. The diffusion assembly 202 is arranged at the wearing side of the magnetic stimulation coil 101. The wearing side of the magnetic stimulation coil 101 is the side of the magnetic stimulation coil 101 close to the user's head. The diffusion assembly 202 receives the near-infrared light from the light source part 201 and diffuses the received near-infrared light. The diffused near-infrared light is emitted through the emission surface 2023 of the diffusion assembly 202 to irradiate the user's head. Preferably, the material of the diffusion assembly 202 is selected from light-transmitting materials. The diffusion assembly 202 can be configured to be free of ferromagnetic materials, that is, compatible with the environment of high magnetic induction intensity.

[0031] In this way, the relatively thin diffusion assembly 202 compatible with the environment of high magnetic induction intensity is arranged 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, ensuring the treatment effect of TMS, and the near-infrared light emitted by the light source part 201 irradiates a wide area of the user's head through the diffusion effect of the diffusion assembly 202, so that the transcranial near-infrared light covers most of the brain area of the head as much as possible. After being used with the magnetic stimulation coil 101, the stimulated brain volume is wide enough.

[0032] Further, the light source part 201 is arranged at a position where the magnetic field intensity of the magnetic stimulation coil 101 is less than a first threshold value. The first threshold value is not greater than 2T. This can significantly reduce the interference between the optical stimulation module 200 and the magnetic stimulation module 100 during use. The interference includes the effect of the magnetic field on the ferromagnetic material in the light source part 201 and the disturbance of the ferromagnetic material in the light source part 201 to the magnetic field. The transcranial magneto-optical neuromodulation device 1 can have both TMS and near-infrared light irradiation capabilities, effectively cooperating in time domain and spatial domain to perform optical and magnetic regulation on the target brain area. It can be understood that the light source part 201 described herein is a device that directly emits near-infrared light, such as an LED assembly, a laser, etc., which is distinguished from a passive light transmission member 203 that only transmits near-infrared light. Compared with the light transmission member 203 such as an optical fiber and an optical device, as a device that directly emits near-infrared light, the light source part 201 contains an electroluminescent device, which is more likely to contain ferromagnetic metal or non-ferromagnetic metal. In some embodiments, even if the light source part 201 itself does not contain metal, there is also current in the cable connected thereto, so the light source part 201 is arranged at a position where the magnetic field intensity of the magnetic stimulation coil 101 is less than a first threshold value in the present application to reduce the interference between the optical and magnetic.

[0033] The transcranial photomagnetic nerve regulation device 1 provided by the embodiment of the present application can stimulate a wide brain volume and a deeper depth under the cerebral cortex at the same time through effective photomagnetic cooperation. Near-infrared light irradiation is mainly used to reduce the formation of β-amyloid plaques and reduce damage to the nervous system. Transcranial magnetic stimulation is mainly used to stimulate the nervous system of the cerebral cortex and the periphery, enhance the activity of nerves, and promote nerve repair. Photomagnetic cooperation effectively improves the treatment effect.

[0034] In some embodiments, the magnetic stimulation module 100 further comprises a shell 102 arranged outside the magnetic stimulation coil 101, and the diffusion assembly 202 is arranged on the wearing side of the shell 102. The side of the shell 102 close to the user's head is the wearing side of the shell 102. Referring to Figure 2 , Figure 2 The shell 102 is not shown in the middle, and it can be understood that the shell 102 is arranged outside the magnetic stimulation coil 101, and the diffusion assembly 202 is arranged outside the shell 102 and separated from the shell 102. In use, the diffusion assembly 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 assembly 202. During treatment, the magnetic stimulation coil 101 or the shell 102 can be in close contact with the diffusion assembly 202, and the diffusion assembly 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 close to the head, ensuring the depth of TMS, thereby ensuring the treatment effect of TMS; or the magnetic stimulation coil 101 or the shell 102 can be spaced apart from the diffusion assembly 202 by a distance, such as not more than 20 mm. In this way, during treatment, the magnetic stimulation coil 101 or the shell 102 does not tightly press the diffusion assembly 202 against the user's head, so that the user does not feel strong confinement and oppression, and the use is more comfortable, and the user is more cooperative during treatment.

[0035] In other embodiments, referring to Figure 3For example, the magnetic stimulation coil 101 is an 8-shaped coil, the shell 102 is arranged around the outer side of the magnetic stimulation coil 101, the diffusion assembly 202 is arranged outside the shell 102 and on the wearing side of the shell 102 and is arranged in close contact with the shell 102. The side of the diffusion assembly 202 away from the shell 102 is the exit surface 2023, and the near-infrared light is emitted from the exit surface 2023 after being diffused by the diffusion assembly 202 to irradiate the head of the user. It can be understood that the shape of the diffusion assembly 202 can be adapted to the wearing side of the shell 102, such as a circular shape, an elliptical shape, an 8-shaped coil, the surface of the shell 102 has a cavity hole, and the diffusion assembly 202 also has a hole at the position corresponding to the cavity hole to adapt to the shell 102; the wearing side surface of the H-shaped or double-cone-shaped shell 102 is not a plane or has a curvature, and the diffusion assembly 202 is arranged in the same shape as the wearing side of the H-shaped or double-cone-shaped shell 102 to improve the adaptability of the structure assembly. In some embodiments, the shape of the diffusion assembly 202 can also not completely adapt to the wearing side of the shell 102, such as for the shell 102 having a cavity hole, the diffusion assembly 202 can not have a hole at the position corresponding to the cavity hole. Since the material of the diffusion assembly 202 does not affect the magnetic field strength generated by the magnetic stimulation coil 101, such an arrangement does not reduce the treatment effect, but the irradiation area of the diffusion assembly 202 is larger, and the treatment effect is better. The shape of the diffusion assembly 202 and the degree of adaptation are not specifically limited here, as long as they do not affect the transcranial magnetic stimulation of the magnetic stimulation coil 101 to the head of the user.

[0036] In some embodiments, the magnetic stimulation module 100 further comprises a shell 102 arranged outside the magnetic stimulation coil 101, and the diffusion assembly 202 is arranged on the wearing side of the shell 102. The diffusion assembly 202 is arranged in the shell 102, the shell 102 has a wearing surface that is transparent, and the wearing surface is configured as the exit surface 2023 of the diffusion assembly 202. In this way, the diffusion assembly 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 assembly 202 and the magnetic stimulation coil 101 can share a set of cooling mechanisms, which saves materials, facilitates configuration, improves the comfort of the user, and prevents burns caused by high temperatures. Further, the operator can hold the TMS magnetic bat just above the target area on the head to perform transcranial magnetic stimulation on the target area while also performing near-infrared light irradiation on the target area.

[0037] The inventor of the present application has found through tests that the closer to the edge of the magnetic stimulation coil 101 in the transverse direction and the more deviated from the center of the magnetic stimulation coil 101 in the longitudinal direction, the magnetic field strength will be significantly reduced. Taking the 8-shaped coil as an example, referring to FIG. 4(a) and FIG. 4(b), the distribution of the magnetic field strength of the 8-shaped coil along the x-axis direction and the distribution of the magnetic field strength of the 8-shaped coil along the y-axis direction, the coil D structure in FIG. 4(a) and FIG. 4(b) is specifically an inner diameter of 56 mm (each ring), an outer diameter of 87 mm, and a number of turns of 9 (*2). The circular coil, double-tapered coil and H-shaped coil all have similar situations, which will not be repeated here. Therefore, by setting the light source part 201 to be away from the center of the magnetic stimulation coil 101 in the transverse direction and the longitudinal direction, at the edge, or even more peripheral, the changing magnetic field generated by the magnetic stimulation coil 101 will have less effect on the position of the light source part 201, not only significantly reducing the heat generation, ensuring the stability of the working current of the light source part 201, but also effectively inhibiting the interference of the current of the light source part 201 and its wire on the magnetic field of the magnetic stimulation coil 101.

[0038] In some embodiments, the magnetic stimulation coil 101 has a cavity hole, and the light source part 201 and / or the light transmission member 203 connected with the light source part 201 can be correspondingly arranged with the cavity hole, and the exit surface 2023 of the diffusion assembly 202 is arranged on the wearing side of the magnetic stimulation coil 101. The cavity hole provides sufficient layout space, and the light transmission member 203 or the light source part 201 without containing metal materials, or the light source part 201 containing ferromagnetic materials is packaged in a shielding box made of non-ferromagnetic metal materials (such as aluminum), can be correspondingly arranged in the cavity hole. Through the latter way, the magnetic field strength of the magnetic stimulation coil 101 at the actual space position where the light source part 201 containing ferromagnetic materials is arranged is still less than the first threshold value.

[0039] Further, taking the magnetic stimulation coil 101 as a circular coil as an example, the circular coil has a cavity hole in the middle, the cavity hole can be used to simultaneously arrange the light source part 201 and the diffusion assembly 202, or the cavity hole can be used to simultaneously arrange the light transmission member 203 connected with the light source part 201 and the diffusion assembly 202, or the cavity hole can be used to simultaneously arrange the light source part 201, the light transmission member 203 connected with the light source part 201 and the diffusion assembly 202. At this time, the light source part 201 is arranged corresponding to the circumferential surface of the cavity hole, for example, the light source part 201 is arranged around the outer circumferential surface of the diffusion assembly 202 and is arranged on the inner circumferential surface of the cavity hole at the same time, and the exit surface 2023 of the diffusion assembly 202 is arranged on the wearing side of the magnetic stimulation coil 101. Since the magnetic field strength at the position of the circumferential edge of the cavity hole is relatively small (especially compared to the center of the cavity hole), the light source part 201 is arranged corresponding to the circumferential surface of the cavity hole, the influence on the light source part 201 and the magnetic stimulation coil 101 is relatively small, and the space arrangement is reasonably utilized without affecting the use. The method of simultaneously arranging the light transmission member 203 and the diffusion assembly 202 by using the cavity hole, or simultaneously arranging the light source part 201, the light transmission member 203 and the diffusion assembly 202 by using the cavity hole is similar to the above, and will not be described here.

[0040] In some embodiments, as shown in FIG. 5(a), taking the magnetic stimulation coil 101 as a circular coil as an example, the circular coil has a cavity hole in the middle, the light source part 201 (such as containing ferromagnetic metal which can be magnetically shielded as needed, which is not shown in the figure) is arranged in the cavity hole of the circular coil, and the diffusion assembly 202 is located below the light source part 201. At the same time, the diffusion assembly 202 is located on the wearing side of the magnetic stimulation coil 101 and is arranged close to the magnetic stimulation coil 101, and the shape of the diffusion assembly 202 is adapted to the shape of the wearing side of the magnetic stimulation coil 101.

[0041] In some embodiments, as shown in FIG. 5(b), taking the magnetic stimulation coil 101 as a circular coil as an example, the circular coil has a cavity hole in the middle, the diffusion assembly 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 assembly 202 is adapted to the shape of the wearing side of the magnetic stimulation coil 101, and the diffusion assembly 202 is provided with a hole at a position corresponding to the cavity hole of the circular coil. The light transmission member 203 connected with the light source part 201 passes through the cavity hole of the circular coil and enters the hole of the diffusion assembly 202 to connect with the diffusion assembly 202 to transmit near-infrared light from the remote light source part 201. In this way, the cavity hole can be fully utilized to arrange the light transmission member 203, and since the light source part 201 is arranged away from the magnetic stimulation coil 101, the light transmission member 203 such as an optical fiber does not contain metal, and the space utilization rate is greatly increased without affecting normal use.

[0042] In some embodiments, as shown in FIG. 5(c), the magnetic stimulation coil 101 is also taken as an example of a circular coil, and the circular coil has a cavity hole in the middle. The diffusion assembly 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 assembly 202 is adapted to the shape of the wearing side of the magnetic stimulation coil 101. The diffusion assembly 202 is provided with a hole at a position corresponding to the cavity hole of the circular coil. The light source part 201 is located on the inner periphery close to the hole and the outer periphery away from the hole of the diffusion assembly 202. Since the inner periphery of the diffusion assembly 202 is close to the cavity hole position of the magnetic stimulation coil 101, and the outer periphery of the diffusion assembly 202 is away from the center of the magnetic stimulation coil 101 and located at the edge thereof, when the light source part 201 is located on the inner periphery and the outer periphery of the diffusion assembly 202, the position is located at a relatively small magnetic field strength, which can not affect the normal use of the magnetic stimulation module 100 and the light stimulation module 200. And when the light source part 201 is located on the inner periphery of the diffusion assembly 202, the cable connected with the light source part 201 can be arranged through the cavity hole of the magnetic stimulation coil 101, which can make full use of the space.

[0043] In some embodiments, the light source part 201 includes an LED assembly, and the LED assembly is arranged on the inner periphery and / or the outer periphery of the diffusion assembly 202, and the LED assembly is configured not to contain ferromagnetic material. Since the diffusion assembly 202 is arranged on the wearing side of the magnetic stimulation coil 101 and is used for diffusing near-infrared light, the positions of the diffusion assembly 202 and the magnetic stimulation coil 101 need to be correspondingly arranged to effectively cooperate to perform light-magnetic regulation on the target brain area in time domain and space domain. The diffusion assembly 202 will be located at a position with strong magnetic field strength. When the light source part 201 is an LED assembly, the LED assembly cannot contain ferromagnetic material to avoid eddy current or heat generated in the metal by the changing magnetic field.

[0044] Further, when the magnetic stimulation coil 101 has a cavity hole, the shape of the diffusion assembly 202 is adapted to the shape of the wearing side of the magnetic stimulation coil 101, and also has a hole in the middle. The LED assembly can be arranged on the inner periphery of the diffusion assembly 202, or on the outer periphery of the diffusion assembly 202, or on both the inner periphery and the outer periphery of the diffusion assembly 202. Since the magnetic field intensity at the cavity hole position and the outer periphery of the magnetic stimulation coil 101 is relatively small, the LED assembly is located at a position where the magnetic field intensity is relatively small when it is arranged on the inner periphery and the outer periphery of the diffusion assembly 202, and does not affect the normal use of the magnetic stimulation module 100 and the light stimulation module 200. Further, the LED assembly is connected with a cable, 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 instead of being directly grounded, for suppressing common-mode interference signals caused by strong magnetic fields to the wire. The configuration of the LED assembly has a lower cost, and compared with introducing a laser, the control difficulty and safety are better. The control module in the host can be realized by a processor, and the LED driving module can be an LED driving circuit. The processor can control the LED driving circuit to drive the LED assembly to emit near-infrared light.

[0045] In some embodiments, the light source part 201 includes a light emitting component, and the light stimulation module 200 further includes a light transmission part 203 connected with the light emitting component. The light emitting component is configured to contain a ferromagnetic material and is away from the wearing side of the magnetic stimulation coil 101. The light transmission part 203 is optically coupled to the diffusion assembly 202. The light emitting component includes devices such as lasers and LED lamps that directly emit light sources, and is an active device containing a ferromagnetic material. The light transmission part 203 includes optical fibers and the like for light transmission, and transmits the light emitted by the light emitting component. The light emitting component 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 component is located at a position where the magnetic field intensity is close to 0. Since the light transmission part 203 does not contain a ferromagnetic material, it can be located at any position of the magnetic field intensity, and the position is not limited here. The light transmission part 203 is optically coupled to the diffusion assembly 202 in various ways, for example but not limited to being arranged in the diffusion assembly 202.

[0046] In some embodiments, as Figure 6As shown, it is a cross-sectional view of the diffusion assembly 202 which is flat, and the light source part 201 is taken as an example of the LED assembly, which is arranged on the outer periphery of the diffusion assembly 202. The LED assembly also has other arrangement modes, which have been listed before and will not be repeated here. The diffusion assembly 202 includes a body 2021, and a plurality of light guide points 2022 are arranged on the side of the body 2021 opposite to the exit surface 2023 of the diffusion assembly 202. The near-infrared light received by the diffusion assembly 202 is diffusely reflected by each light guide point 2022 and then exits from the exit surface 2023 to irradiate the head of the user. The exit surface 2023 of the diffusion assembly 202 corresponds to the side of the light stimulation module 200 to be worn on the head. The diffusion assembly 202 can be rigid or flexible, and can be integrated or split, and can be flat or curved, as long as it can be adapted to the head of the user, and the form of the diffusion assembly 202 is not limited here. The LED assembly and the diffusion assembly 202 form good optical coupling, and the emitted near-infrared light enters the body 2021. The near-infrared light received by the body 2021 is diffusely reflected by each light guide point 2022 in various directions and then exits from the exit surface 2023 to irradiate the head of the user. In this way, the near-infrared light emitted by the LED assembly can be converted into a surface light source, which exits from the exit surface 2023, so that the near-infrared light can stimulate a wide enough brain volume with a relatively uniform dose.

[0047] Further, the manufacturing process of the light guide point 2022 can adopt any one of laser engraving, chemical etching, V-cut, and UV screen printing.

[0048] Further, the main material of the body 2021 of the diffusion assembly 202 can be acrylic (PMMA), or other materials with good light transmission, such as polycarbonate (PC), MS plate (a copolymer synthesized by taking 50% polymethyl methacrylate (PMMA) and 50% styrene (PS) as main raw materials), etc.

[0049] Further, 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 assembly 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. That is, the diffusion assembly 202 actually also serves as an adaptation mechanism of the magnetic stimulation coil 101 and the head, helping the magnetic stimulation coil 101 to firmly and comfortably approach the head of the subject, and reducing optical refraction and loss in the gap between the diffusion assembly 202 and the head.

[0050] Further, the light guide points 2022 are arranged unevenly, and through various light guide points 2022 with different densities and sizes, the exit surface 2023 of the diffusion assembly 202 can emit light uniformly.

[0051] Further, the diffusion assembly 202 further comprises a reflecting part 2024, which is arranged opposite to the exit surface 2023 and on the side of the light guide point 2022 away from the exit surface 2023. The reflecting part 2024 is arranged on the opposite side of the exit surface 2023, below the light guide point 2022, to reflect the near-infrared light irradiated to the reflecting part 2024 back into the body 2021, so as to improve the use efficiency of the light. In addition to using the LED assembly, a near-infrared laser LED can also be used, or an optical fiber can be installed to guide the near-infrared light from the outside into the body 2021, which will not be described in detail here.

[0052] In some embodiments, the reflecting part 2024 is made of a non-metal high-reflectivity material or a non-ferromagnetic metal material. During use, the reflecting part 2024 of the diffusion assembly 202 is close to the magnetic stimulation coil 101, and the reflecting part 2024 can use a non-metal to reduce the heat generated by the induced current of the changing magnetic field from the magnetic stimulation coil 101; or, the reflecting part 2024 can also use a non-ferromagnetic metal material, such as a copper foil or a silver foil, to avoid disturbing the magnetic field of the magnetic stimulation coil 101; the reflecting part 2024 as a metal will generate heat, and the generated heat can be cooled together with the magnetic stimulation coil 101 by using liquid cooling or air cooling. In some embodiments, the transcranial optomagnetic neuromodulation device 1 further comprises a cooling mechanism, the magnetic stimulation coil 101 is arranged in the cooling medium supplied by the cooling mechanism, and the reflecting part 2024 is close to the magnetic stimulation coil 101 to allow 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 reflecting part 2024 can also be placed in the cooling medium and share the cooling medium and cooling circuit with the magnetic stimulation coil 101. In this way, the magnetic stimulation coil 101 and the light stimulation module 200 are simultaneously cooled by using a set of cooling mechanism, which can reasonably utilize resources.

[0053] Further, the material of the body 2021 of the diffusion assembly 202 can be selected as a thermal insulator, such as PC and CPI, and the exit surface 2023 is attached to the head of the subject, so that the heat generated from the magnetic stimulation coil 101 and the reflecting part 2024 is less likely to be transmitted to the user's head, thereby avoiding scalding the user.

[0054] In some embodiments, the shape of the magnetic stimulation coil 101 is selected from one of a circle, an ellipse, an 8-shaped, an H-shaped or a double-cone shape, and preferably, the magnetic stimulation coil 101 is selected as an H-shaped coil to act on a deeper and more extensive target area.

[0055] In some embodiments, the ratio of the wearing side of the magnetic stimulation coil 101 being blocked by the exit surface 2023 of the diffusion assembly 202 is greater than a predetermined threshold. Since the material of each part of the body 2021 of the diffusion assembly 202 is selected from non-metallic materials or non-ferromagnetic metallic materials, the diffusion assembly 202 will not affect the effect of the combined use of light and magnetism in the magnetic field environment. Further, 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 being blocked by the exit surface 2023 of the diffusion assembly 202, the better the effect of the target area of the combined stimulation of light and magnetism, which can achieve a certain stimulation area and a deeper stimulation depth, effectively improving the treatment effect.

[0056] In some embodiments, the transcranial photomagnetic neuromodulation device 1 further comprises a control module connected with the magnetic stimulation module 100 and the light stimulation module 200, respectively, to control the light stimulation module 200 and the magnetic stimulation module 100 to work in time sequence or simultaneously. For example, when using the LED assembly, the light stimulation module 200 can be turned off when the magnetic stimulation module 100 is working, and the magnetic stimulation module 100 can not work when the light stimulation module 200 is turned on. In this way, by controlling the light stimulation module 200 and the magnetic stimulation module 100 to work in time sequence, the mutual interference between the combined use of light and magnetism is reduced, further improving the safety and stability during use. For another example, if the light emitting member (containing ferromagnetic metal) emits near-infrared light, the light is guided by the light transmission member 203. Since the light emitting member 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 member. Therefore, the magnetic stimulation module 100 and the light stimulation module 200 can work simultaneously, the stimulation depth is deepened, and the treatment effect is effectively improved.

[0057] 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 a preset time after the light stimulation module 200 starts, send a second control signal to the magnetic stimulation module 100 to control the magnetic stimulation module 100 to start. After the light stimulation module 200 starts for a certain time, the near-infrared light stimulation can make the neurons in a more easily activated state. In this case, the magnetic stimulation module 100 is controlled to start, so that the effect of TMS stimulation is more significant, greatly improving the treatment effect of the target area. The preset time can be set according to the needs of treating different diseases, which can be 30s, 60s, 90s, 120s, etc., which is not limited here.

[0058] In some embodiments, the thickness of the diffusion assembly 202 is no more than 10 mm. Further, the thickness of the diffusion assembly 202 can be in the range of 3-10 mm, even 3-7 mm, or even 3-6 mm, so that the stimulation depth can reach the cerebral cortex, or even a depth deeper than the cerebral cortex, such as 2 cm, 3 cm, or even deeper, when transcranial magnetic stimulation is performed. The stimulation depth of a single H-coil is greater than 6 cm, which can efficiently stimulate deep brain nuclei. At a stimulation intensity of 120% MT, the H-coil can still induce an over-threshold electric field at a depth of 1.8 cm below the cortex. The effective stimulation depth of a double-cone coil can reach 6 cm, which can stimulate deeper brain regions other than the cerebral cortex, such as the cerebellum, anterior cingulate gyrus, and orbitofrontal lobe. The double-cone coil can generate an electric current at a depth of 4-5 cm below the intersection of the two coils, so the stimulation site is deeper. Since the diffusion assembly 202 is very thin, and the internal space of the magnetic stimulation coil 101 is fully utilized to accommodate the light source part 201 and / or the diffusion assembly 202 of the light stimulation module 200, the magnetic stimulation intensity can still act on the deep brain when the transcranial photomagnetic neuromodulation device 1 is used in combination.

[0059] In some embodiments, for users with dark and thick hair, the transcranial photomagnetic neuromodulation device 1 can also be used in combination with a light guide comb. The user can wear the light guide comb to push the hair away to form an optical path for near-infrared light (e.g., the transparent holding part of the light guide comb - the scalp under the sparse hair of the transparent holding part - the skull under the scalp), and the transmittance of the light can increase by 20-30%. At the same time, the light guide comb provides thermal insulation and physical isolation, and also provides support for the diffusion assembly 202, so that heat is less likely to be transferred to the scalp.

[0060] In some embodiments, the light guide comb can be integrated into the diffusion assembly 202. When worn, the light guide comb directly pushes the user's hair away from the front, and the diffusion assembly 202 is positioned, and then the magnetic stimulation coil 101 is worn. The magnetic stimulation coil 101 is positioned relative to the head of the subject, and the photomagnetic combined modulation can be performed, which is convenient for use and improves the treatment effect.

[0061] The application provides a transcranial photomagnetic neuromodulation device 1, which corresponds the light stimulation module 200 and the magnetic stimulation module 100, and sets the diffusion assembly 202 of the light stimulation module 200 on the wearing side of the magnetic stimulation coil 101 in the magnetic stimulation module 100, so that the relatively thin diffusion assembly 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 action depth of TMS, thereby improving the treatment effect of TMS; the diffusion assembly 202 receives near-infrared light from the light source part 201 in the light stimulation module 200 and diffuses the near-infrared light, and the diffused near-infrared light is emitted through the emission surface 2023 of the diffusion assembly 202 to irradiate the head of the user, so that the near-infrared light emitted by the light source part 201 irradiates the head of the user through the diffusion effect of the diffusion assembly 202 as much as possible to cover most of the brain area of the head, and after being used with the magnetic stimulation coil 101, the stimulated brain volume is wide enough; at the same time, the light source part 201 is arranged at a position where the magnetic field intensity of the magnetic stimulation coil 101 is less than the first threshold value, so that the interference between the light stimulation module 200 and the magnetic stimulation module 100 is significantly reduced during use, and the transcranial photomagnetic neuromodulation device 1 can have the functions of TMS and near-infrared light irradiation, and effectively cooperates with the target brain area in the time domain and the space domain to perform photomagnetic regulation.

[0062] The transcranial photomagnetic neuromodulation device 1 provided by the application can effectively stimulate a wide brain volume and a deeper depth under the cerebral cortex at the same time through effective photomagnetic cooperation, and effectively improve the treatment effect.

[0063] In addition, although the exemplary embodiments have been described herein, the scope thereof includes any and all embodiments having equivalent elements, modifications, omissions, combinations (for example, solutions in which various embodiments are crossed), adaptations, or variations based on the present application. The elements in the claims will be broadly interpreted based on the language adopted in the claims, and are not limited to the examples described in the specification or during the implementation of the application, and the examples will be interpreted as non-exclusive. Therefore, the specification and examples are intended to be considered only as examples, and the true scope and spirit are indicated by the entire scope of the appended claims and their equivalents.

[0064] The above description is intended to be illustrative, and not restrictive. For example, the above-described examples (or one or more aspects thereof) can be used in combination with each other. Other embodiments can be used, which will be apparent to those of ordinary skill in the art upon reviewing the above description. Additionally, the various features described above can be grouped together or divided into separate features for simplicity. This should not be interpreted as requiring that the claimed subject matter must comprise the particular grouped features. Rather, the subject matter described herein is intended to encompass all possible combinations of the features described or illustrated herein. The scope of the present application should be determined by reference to the appended claims, along with the full scope of equivalents to which such claims are entitled. The claims, as set forth below, are intended to be illustrative and not restrictive.

[0065] The above embodiments are only exemplary embodiments of the present application, not intended to limit the present application, and the protection scope of the present application is defined by the claims. Those skilled in the art can make various modifications or equivalent replacements to the present application within the spirit and protection scope of the present application, and such modifications or equivalent replacements should also be considered to fall within the protection scope of the present application.

Claims

1. A transcranial magnetoencephalography neuromodulation device, comprising: The transcranial magnetic stimulation and the transcranial near-infrared light stimulation in the transcranial photomagnetic neuromodulation device are both used for functional regulation of the nervous system, and the transcranial photomagnetic neuromodulation device comprises: a magnetic stimulation module comprising a magnetic stimulation coil for applying transcranial magnetic stimulation; a light stimulation module corresponding to the magnetic stimulation module, the light stimulation module comprising a light source part and a single sheet-shaped diffusion assembly, the light source part emitting near-infrared light, the single sheet-shaped diffusion assembly being arranged on the wearing side of the magnetic stimulation coil as an adaptation mechanism of the magnetic stimulation coil and the head, the light source part being arranged on the inner and / or outer circumferential side of the diffusion assembly to supply the near-infrared light thereto, the diffusion assembly diffusing the near-infrared light, and the diffused near-infrared light being emitted through the exit surface of the diffusion assembly to irradiate the head of the user; wherein the light source part is located at a position where the magnetic field intensity of the magnetic stimulation coil is less than a first threshold value.

2. The transcranial magnetoencephalography neuromodulation device of claim 1, wherein, The magnetic stimulation module further comprises a shell arranged outside the magnetic stimulation coil, and the diffusion assembly is arranged on the wearing side of the shell, and the diffusion assembly is configured in one of the following modes: the diffusion assembly is arranged outside the shell and separated from or closely arranged with the shell; the diffusion assembly is arranged inside the shell, and the shell has a light-transmitting wearing surface configured as the exit surface of the diffusion assembly.

3. The transcranial magnetoencephalography neuromodulation device of claim 1, wherein, The magnetic stimulation coil has a cavity hole, and the light source part and / or a light transmission member connected with the light source part are arranged corresponding to the cavity hole, and the exit surface of the diffusion assembly is arranged on the wearing side of the magnetic stimulation coil.

4. The transcranial magnetoencephalography neuromodulation device of claim 1, wherein, The light source part comprises an LED assembly arranged on the inner and / or outer circumferential side of the diffusion assembly, and the LED assembly is configured not to contain ferromagnetic material.

5. The transcranial magnetoencephalography neuromodulation device of claim 1, wherein, The light source part comprises a light emitting member, and the light stimulation module further comprises a light transmission member connected with the light emitting member, the light emitting member is configured to contain ferromagnetic material, and is away from the wearing side of the magnetic stimulation coil, and the light transmission member is arranged in the diffusion assembly.

6. The transcranial magnetoencephalography neuromodulation device according to any one of claims 1 to 5, wherein, The diffusion assembly comprises a body, and a plurality of light guide points are arranged on the side of the body opposite to the exit surface of the diffusion assembly, and the near-infrared light received by the diffusion assembly is diffusely reflected through each light guide point and then emitted through the exit surface to irradiate the head of the user.

7. The transcranial magnetoencephalography neuromodulation device of claim 6, wherein, Each light guide point is arranged unevenly.

8. The transcranial magnetoencephalography neuromodulation device of claim 6, wherein, The diffusion assembly further comprises a reflection part arranged opposite to the exit surface and located on the side of the light guide point away from the exit surface.

9. The transcranial magnetoencephalography neuromodulation device of any one of claims 1 to 5, wherein, The shape of the magnetic stimulation coil is selected from one of a circle, an ellipse, an 8-shaped, an H-shaped or a double-cone-shaped.

10. The transcranial magnetoencephalography neuromodulation device according to any one of claims 1 to 5, wherein, The ratio of the wearing side of the magnetic stimulation coil blocked by the exit surface of the diffusion assembly is greater than a predetermined threshold value.

11. The transcranial magnetoencephalography neuromodulation device of claim 6, wherein, 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 magnetoencephalography neuromodulation device of claim 8, wherein, The transcranial photomagnetic neuromodulation device further comprises a cooling mechanism, the magnetic stimulation coil is arranged in the cooling medium supplied by the cooling mechanism, and the reflection part is close to the magnetic stimulation coil.

13. The transcranial magnetoencephalography neuromodulation device of claim 8, wherein, The reflection part is made of a non-metal high light reflectivity material or a non-ferromagnetic metal material.

14. The transcranial magnetoencephalography neuromodulation device of any one of claims 1 to 5, wherein, At least part of the diffusion assembly is made of a flexible material to adapt to the head contour of the user.

15. The transcranial magnetoencephalography neuromodulation device of any one of claims 1 to 5, wherein, The transcranial photomagnetic neuromodulation device further comprises a control module connected with the magnetic stimulation module and the light stimulation module respectively, and the control module controls the light stimulation module and the magnetic stimulation module to work in time sequence or simultaneously.

16. The transcranial magnetoencephalography neuromodulation device of claim 15, wherein, The control module is further configured to: send a first control signal to the light stimulation module to control the light stimulation module to start, and send a second control signal to the magnetic stimulation module to control the magnetic stimulation module to start after the light stimulation module starts for a preset time. The thickness of the diffusion assembly is not more than 10 mm.

17. The transcranial magnetoencephalography neuromodulation device of any one of claims 1 to 5, wherein, ​

Images