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

[0001] This application is a divisional application of Chinese invention patent application No. 202510474233.3, filed on April 16, 2025, entitled "Transcranial Optomagnetic Nerve Modulation Device". Technical Field

[0002] This invention relates to the field of medical device technology, specifically to a transcranial nerve modulation device, and more specifically to a transcranial optomagnetic nerve modulation device. Background Technology

[0003] Transcranial magnetic stimulation (TMS) is a painless and non-invasive physical therapy method. It utilizes a high-voltage capacitor within a stimulator to generate a high-voltage current that acts on a magnetic stimulation coil. The time-varying magnetic field generated in the coil passes through the skull, stimulating the cerebral cortex and peripheral nerves, producing induced currents. This alters the action points of nerve cells, influencing neurotransmitter metabolism and neural electrical activity in the brain, thereby triggering a series of physiological and biochemical reactions. These reactions include regulating the excitability of the cerebral cortex, altering synaptic connections, repairing incompletely damaged nerve cells, affecting cerebral blood flow and oxygen levels, promoting the release of neurotransmitters, stimulating the secretion of neurotrophic factors, and inducing neural network oscillations. The lingering effects of TMS stimulation during and after stimulation can be used to regulate the function of the nervous system. It has been applied in various fields, including neuropsychology, rehabilitation, and pediatrics. Some studies have confirmed that TMS stimulation may also have a therapeutic effect on Alzheimer's disease (AD) or mild cognitive impairment (MCI).

[0004] Typically, magnetic stimulation coils have a shallow stimulation depth, only 1.5cm-3cm. Although the stimulation can be indirectly transmitted to remote sites through neural network connections in the stimulation area, or by improving the stimulation coil, such as biconical coils or H-shaped coils, the stimulated brain volume is still not extensive enough.

[0005] Near-infrared photostimulation (NIPS) devices are also used to treat Alzheimer's disease (AD) or massive cerebral insufficiency (MCI). They induce a series of physiological and biochemical reactions by irradiating the brain with an appropriate dose of near-infrared light. Their mechanism of action differs from transcranial Doppler (TMS). NIPS can significantly reduce the volume and number of Aβ plaques in the cerebral cortex and hippocampus, and reduce the accumulation of hyperphosphorylated tau protein. AD is a global brain disease with specific target sites in the brain's functional networks. If TMS and NIPS can be used synergistically to treat AD or MCI, it can effectively eliminate Aβ plaques, one of the pathogenic factors. The deposition of amyloid plaques can also stimulate neural activity and stimulate a wider area of ​​the brain.

[0006] However, combining TMS with near-infrared photostimulation presents at least the following technical obstacles: TMS can generate a magnetic induction intensity of 1-5T at the center of the coil, which strongly attracts ferromagnetic materials. Moreover, the changing magnetic field can generate eddy currents or heat in metals, making it unsuitable to place the irradiation unit with metallic materials between the TMS coil and the subject's head; if the irradiation unit used in near-infrared photostimulation devices is placed outside the coil (opposite to the wearing side), it will be blocked by the coil and will not be able to irradiate the head at all. If it is placed inside the coil (on the 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 and affecting the treatment effect; existing TMS and near-infrared photostimulation devices have relatively simple stimulation sites, and the stimulated brain volume is not extensive enough. Summary of the Invention

[0007] This application aims to provide a transcranial photomagnetic neuromodulation device that can perform photomagnetic modulation on target brain regions in a coordinated manner in the temporal and spatial domains, 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 photomagnetic modulation process, thus ensuring the synergistic therapeutic effect of photomagnetism.

[0008] This invention provides a transcranial photomagnetic neuromodulation device, comprising: a magnetic stimulation module including a magnetic stimulation coil for applying transcranial magnetic stimulation; and a photostimulation module corresponding to the magnetic stimulation module, the photostimulation module including a light source and a diffusion component. The light source emits near-infrared light, and the diffusion component is disposed on the wearing side of the magnetic stimulation coil. The diffusion component receives the near-infrared light from the light source and diffuses the near-infrared light, the diffused near-infrared light is emitted through the emitting surface of the diffusion component to irradiate the user's head; wherein the light source is disposed at a point where the magnetic field strength of the magnetic stimulation coil is less than a first threshold.

[0009] Compared with the prior art, the embodiments of this application can achieve the following beneficial technical effects.

[0010] This application provides a transcranial photomagnetic neuromodulation device. The device includes a photostimulation module and a magnetic stimulation module, with the diffusion component of the photostimulation module positioned on the wearing side of the magnetic stimulation coil in the magnetic stimulation module. This relatively thin diffusion component is located between the magnetic stimulation coil and the head, effectively reducing the distance between them and ensuring the depth of TMS action, thereby improving the therapeutic effect of TMS. The diffusion component receives near-infrared light from the light source in the photostimulation module and diffuses it. The diffused near-infrared light is emitted through the exit surface of the diffusion component to irradiate the head. The light source emits near-infrared light that diffuses through a diffusion component, ensuring that the light covers most of the brain regions as comprehensively as possible. When used in conjunction with a magnetic stimulation coil, the stimulated brain volume is sufficiently extensive. Simultaneously, by positioning the light source at a point where the magnetic field strength of the magnetic stimulation coil is less than a first threshold, interference between the photostimulation module and the magnetic stimulation module is significantly reduced during use. This transcranial photomagnetic neuromodulation device combines TMS and near-infrared light irradiation capabilities, effectively coordinating photomagnetic modulation of the target brain region in both the temporal and spatial domains.

[0011] The transcranial photomagnetic neuromodulation device provided in this application can effectively stimulate a sufficiently large brain volume and a deeper subcortical region through photomagnetic synergy, thereby effectively improving the treatment effect. Attached Figure Description

[0012] In drawings that are not necessarily drawn to scale, the same reference numerals may describe similar parts in different views. The same reference numerals with or without letter suffixes may indicate different instances of similar parts. The drawings illustrate various embodiments generally by way of example rather than limitation, and are used, together with the description and claims, to explain the disclosed embodiments. Where appropriate, the same reference numerals are used in all drawings to refer to the same or similar parts. Such embodiments are illustrative and not intended to be exhaustive or exclusive embodiments of the apparatus or method.

[0013] Figure 1 This is a schematic diagram of the structure of a transcranial optomagnetic neuromodulation device according to an embodiment of the present invention; Figure 2 This is a perspective view of a transcranial photomagnetic neuromodulation device according to an embodiment of the present invention, viewed from the front. Figure 3 This is a perspective view of the magnetic stimulation module in a transcranial photomagnetic neuromodulation device according to an embodiment of the present invention; Figure 4(a) is a distribution diagram of the magnetic field strength of the figure-eight coil along the x-axis; Figure 4(b) is a diagram showing the distribution of the magnetic field strength of the figure-eight coil along the y-axis. Figure 5(a) is a perspective view of the photostimulation module in a transcranial photomagnetic neuromodulation device according to an embodiment of the present invention; Figure 5(b) is a perspective view of the photostimulation module in a transcranial photomagnetic neuromodulation device according to another embodiment of the present invention; Figure 5(c) is a perspective view of the photostimulation module in a transcranial photomagnetic neuromodulation device according to another embodiment of the present invention; Figure 6 This is a cross-sectional view of a plate-shaped diffusion component in a transcranial photomagnetic neuromodulation device according to an embodiment of the present invention.

[0014] The components indicated by the reference numerals in the figure: 1- Transcranial photomagnetic neuromodulation device; 100- Magnetic stimulation module; 101- Magnetic stimulation coil; 102- Housing; 200- Photostimulation module; 201- Light source; 202- Diffusion assembly; 2021- Body; 2022- Light guide point; 2023- Emission surface; 2024- Reflection part; 203- Light transmission component. Detailed Implementation

[0015] To enable those skilled in the art to better understand the technical solution of the present invention, the present invention will be described in detail below with reference to the accompanying drawings and specific embodiments. The embodiments of the present invention will be further described in detail below with reference to the accompanying drawings and specific examples, but this is not intended to limit the present invention.

[0016] The terms "first," "second," and similar terms used in this invention do not indicate any order, quantity, or importance, but are merely used to distinguish different parts. Terms such as "comprising" or "including" mean that the element preceding the word covers the element listed after the word, and do not exclude the possibility of covering other elements as well.

[0017] In the description of this application, it should be understood that the orientation or positional relationship indicated by directional terms such as "front", "rear", "up", "down", "left", "right", "lateral", "vertical", "horizontal", "top", and "bottom" is generally based on the orientation or positional relationship shown in the accompanying drawings and is only for the convenience of describing this application and simplifying the description. Unless otherwise stated, these directional terms 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 should not be construed as a limitation on the scope of protection of this invention; the directional terms "inner" and "outer" refer to the inner and outer contours relative to the outline of each component itself.

[0018] 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.

[0019] 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.

[0020] 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.

[0021] 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.

[0022] 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... Figure 1-2As shown, the transcranial photomagnetic neuromodulation 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 correspondingly arranged with the magnetic stimulation module 100. The light stimulation module 200 includes a light source 201 and a diffusion component 202. The light source 201 emits near-infrared light, and the diffusion component 202 is disposed on the wearing side of the magnetic stimulation coil 101, wherein the side of the magnetic stimulation coil 101 closest 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 201 and diffuses the received near-infrared light. The diffused near-infrared light is emitted through the emitting 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 as a non-ferromagnetic material, that is, compatible with application environments with high magnetic induction intensity.

[0023] This configuration allows the relatively thin diffusion component 202, which is compatible with high magnetic induction intensity environments, to be positioned between the magnetic stimulation coil 101 and the head. This effectively reduces the distance between the magnetic stimulation coil 101 and the head, ensuring the depth of TMS action and the therapeutic effect of TMS. Furthermore, the near-infrared light emitted by the light source 201 is diffused by the diffusion component 202 and irradiates a wide area of ​​the user's head, allowing the transcranial near-infrared light to cover most of the brain regions as comprehensively as possible. When used in conjunction with the magnetic stimulation coil 101, the stimulated brain volume is sufficiently extensive.

[0024] Furthermore, the light source 201 is positioned where the magnetic field strength of the magnetic stimulation coil 101 is less than a first threshold, which is no greater than 2T. This significantly reduces interference between the photostimulation module 200 and the magnetic stimulation module 100 during use. This interference includes the effect of the magnetic field on the ferromagnetic material in the light source 201 and the disturbance of the magnetic field by the ferromagnetic material in the light source 201. This transcranial photomagnetic neuromodulation device 1 can combine TMS and near-infrared light irradiation capabilities, effectively coordinating photomagnetic modulation of the target brain region in both the temporal and spatial domains. It is understood that the light source 201 described herein is a device that directly emits near-infrared light, such as an LED component or a laser, and is distinct from the passive optical transmission device 203 that only transmits near-infrared light. Compared to the optical transmission device 203, such as an optical fiber or optical device, the light source 201, as a device that directly emits near-infrared light, includes an electroluminescent device and is more likely to contain ferromagnetic or non-ferromagnetic metals. In some embodiments, even if the light source 201 itself does not contain metal, there is current in the cable connected to it. Therefore, in this application, the light source 201 is placed where the magnetic field strength of the magnetic stimulation coil 101 is less than a first threshold to reduce the interference between light and magnetism.

[0025] The transcranial photomagnetic neuromodulation device 1 provided in this application embodiment can simultaneously stimulate a sufficiently wide brain volume and deeper areas under the cerebral cortex through effective photomagnetic synergy. Near-infrared light irradiation is mainly used to reduce β Amyloid plaque formation reduces 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. The synergistic effect of light and magnetism effectively improves the treatment effect.

[0026] In some embodiments, the magnetic stimulation module 100 further includes a housing 102 disposed outside the magnetic stimulation coil 101, and a diffusion component 202 disposed on the wearing side of the housing 102, wherein the side of the housing 102 closest to the user's head is the wearing side of the housing 102. See also Figure 2 , Figure 2 The housing 102 is not shown, but it can be understood that the housing 102 is arranged around the outside of the magnetic stimulation coil 101, and the diffusion component 202 is arranged outside the housing 102 and is separate from the housing 102. In use, the diffusion component 202 is first placed close to the user's head, and then the magnetic stimulation coil 101 of the magnetic stimulation module 100 or the housing 102 is placed close to the diffusion component 202. During treatment, the magnetic stimulation coil 101 or the housing 102 can be placed close to the diffusion component 202. The diffusion component 202 serves as a support between the magnetic stimulation coil 101 or the housing 102 and the user's head. In this way, the magnetic stimulation coil 101 is close to the head, ensuring the depth of TMS action and thus ensuring the therapeutic effect of TMS. Alternatively, the magnetic stimulation coil 101 or the housing 102 can be spaced apart from the diffusion component 202 by a certain distance, such as no more than 20mm. In this way, during treatment, the magnetic stimulation coil 101 or the housing 102 will not press the diffusion component 202 tightly against the user's head, so that the user will not experience a strong feeling of confinement or pressure, making the use more comfortable and the user more cooperative during the treatment process.

[0027] In other embodiments, see Figure 3Taking a figure-eight shaped magnetic stimulation coil 101 as an example, a housing 102 is arranged around the outside of the magnetic stimulation coil 101, and a diffuser assembly 202 is arranged outside the housing 102, located on the wearing side of the housing 102, and closely attached to the housing 102. The side of the diffuser assembly 202 away from the housing 102 is the emission surface 2023. Near-infrared light is diffused by the diffuser assembly 202 and emitted from the emission surface 2023 to irradiate the user's head. It can be understood that the shape of the diffuser assembly 202 can be adapted to the wearing side of the housing 102. For example, if the surface of the housing 102 of a circular, elliptical, or figure-eight shaped coil has cavities, the diffuser assembly 202 is also provided with holes corresponding to the cavities to adapt to the housing 102; if the wearing side surface of an H-shaped or double-cone housing 102 is not flat or has curvature, the diffuser assembly 202 is set to have a shape consistent with the wearing side of the H-shaped or double-cone housing 102 to improve the adaptability of the structural assembly. In some embodiments, the shape of the diffusion component 202 may not be completely adapted to the wearing side of the housing 102. For example, for a housing 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, this arrangement will not reduce the treatment effect; on the contrary, the irradiation area of ​​the diffusion component 202 is larger, resulting in a better treatment effect. The shape and degree of adaptation of the diffusion component 202 are not specifically limited here, as long as they do not affect the application of transcranial magnetic stimulation to the user's head by the magnetic stimulation coil 101.

[0028] In some embodiments, the magnetic stimulation module 100 further includes a housing 102 disposed outside the magnetic stimulation coil 101, a diffusion component 202 disposed on the wearing side of the housing 102, and the housing 102 having a light-transmitting wearing surface configured as the emission surface 2023 of the diffusion component 202. Thus, the diffusion component 202 and the magnetic stimulation coil 101 share the housing 102, which can further reduce the distance between the magnetic stimulation coil 101 and the head, improving the therapeutic effect. Simultaneously, the diffusion component 202 and the magnetic stimulation coil 101 can share a cooling mechanism, saving materials, facilitating configuration, improving user comfort, and preventing burns from excessive heat. Furthermore, by holding the TMS magnetic slap directly above the target area on the head, the operator can simultaneously perform transcranial magnetic stimulation and near-infrared light irradiation on the target area.

[0029] The inventors of this application discovered through testing that the magnetic field strength decreases significantly the closer the magnetic stimulation coil 101 is to its edge in the horizontal direction and the further it is from the center of the magnetic stimulation coil 101 in the vertical direction. Taking a figure-eight coil as an example, refer to Figure 4(a) and Figure 4(b) for the distribution of the magnetic field strength of the figure-eight coil along the x-axis and y-axis, respectively. The coil D structure in Figures 4(a) and 4(b) has an inner diameter of 56 mm (per ring), an outer diameter of 87 mm, and 9 turns (*2). Similar situations exist for circular coils, biconical coils, and H-shaped coils, and will not be described further here. Therefore, by setting the light source 201 to be far from the center of the magnetic stimulation coil 101 in both the horizontal and vertical directions, located at its edge or even further out, the effect of the changing magnetic field generated by the magnetic stimulation coil 101 on the location of the light source 201 will be smaller. This not only significantly reduces heat generation and ensures the stability of the operating current of the light source 201, but also effectively suppresses the interference of the current of the light source 201 and its wires on the magnetic field of the magnetic stimulation coil 101.

[0030] In some embodiments, the magnetic stimulation coil 101 has a cavity, and the light source 201 and / or the light transmission element 203 connected to the light source 201 can be disposed corresponding to the cavity. The emitting surface 2023 of the diffusion component 202 is disposed on the wearing side of the magnetic stimulation coil 101. The cavity provides sufficient space for placement. The light transmission element 203 or the light source 201 without metal material, or the light source 201 containing ferromagnetic material encased in a shielding box made of non-ferromagnetic metal material (e.g., aluminum), can be disposed corresponding to the cavity. In the latter case, the magnetic field strength of the magnetic stimulation coil 101 is still less than the first threshold at the actual spatial location where the light source 201 containing ferromagnetic material is disposed.

[0031] Furthermore, taking a circular magnetic stimulation coil 101 as an example, the circular coil has a cavity in the middle. The cavity can be used to simultaneously arrange the light source 201 and the diffuser 202, or simultaneously arrange the light transmission element 203 connected to the light source 201 and the diffuser 202, or simultaneously arrange the light source 201, the light transmission element 203 connected to the light source 201, and the diffuser 202. In this case, the light source 201 is arranged correspondingly to the periphery of the cavity, such as the light source 201 surrounding the outer periphery of the diffuser 202 and simultaneously located on the inner periphery of the cavity. The emission surface 2023 of the diffuser 202 is located on the wearing side of the magnetic stimulation coil 101. Since the magnetic field strength at the periphery of the cavity is relatively small (especially compared to the center of the cavity), arranging the light source 201 correspondingly to the periphery of the cavity has a relatively small impact on the light source 201 and the magnetic stimulation coil 101, making reasonable use of space without affecting its use. The method of simultaneously arranging the light transmission component 203 and the diffusion component 202 using the cavity aperture, or simultaneously arranging the light source unit 201, the light transmission component 203 and the diffusion component 202 using the cavity aperture, is similar to the above and will not be described in detail here.

[0032] 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 part 201 (if it contains ferromagnetic metal, it can be magnetically shielded as needed, which is not shown in the figure) is disposed in the cavity of the circular coil, the diffusion component 202 is located below the light source part 201, and 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.

[0033] In some embodiments, as shown in FIG5(b), 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, 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 has a hole corresponding to the position of the cavity of the circular coil. The light transmission component 203 connected to the light source 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 near-infrared light from the distant light source 201. With this arrangement, the position of the cavity can be fully utilized to arrange the light transmission component 203. Since the light source 201 is located far away from the magnetic stimulation coil 101, the light transmission component 203, such as an optical fiber, does not contain metal, which greatly increases the space utilization without affecting normal use.

[0034] 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, 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 has a hole corresponding to the position of the cavity of the circular coil. The light source part 201 is located on the inner periphery of the diffusion component 202 near the hole and on the outer periphery away from the hole. Since the inner periphery of the diffusion component 202 is close to the cavity 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 located at its edge, the position of the light source part 201 when it is located on the inner periphery and outer periphery of the diffusion component 202 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. Furthermore, when the light source 201 is located on the inner periphery of the diffusion assembly 202, the cable connected to the light source 201 can pass through the cavity of the magnetic stimulation coil 101, thus making full use of the space.

[0035] In some embodiments, the light source 201 includes an LED assembly disposed on the inner and / or outer periphery of the diffusion assembly 202, and the LED assembly is configured not to contain ferromagnetic materials. Since the diffusion assembly 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 assembly 202 and the magnetic stimulation coil 101 need to be correspondingly arranged to effectively perform photomagnetic modulation of the target brain region in both the temporal and spatial domains. The diffusion assembly 202 will be located at a position with a strong magnetic field. When the light source 201 is an LED assembly, the LED assembly cannot contain ferromagnetic materials to avoid the changing magnetic field generating eddy currents or heat in the metal.

[0036] Furthermore, when the magnetic stimulation coil 101 has a cavity, the shape of the diffuser component 202 is adapted to the shape of the wearing side of the magnetic stimulation coil 101, and it also has a hole in the middle. The LED component can be set on the inner periphery of the diffuser component 202, or on the outer periphery of the diffuser component 202, or simultaneously on both the inner and outer peripheries of the diffuser component 202. Since the magnetic field strength at the cavity location and the outer periphery of the magnetic stimulation coil 101 is relatively small, the LED component is located at a location with relatively low magnetic field strength when it is located on the inner and outer peripheries of the diffuser component 202, which does not affect the normal use of the magnetic stimulation module 100 and the photostimulation module 200. Furthermore, the LED component is connected to a cable made of copper wire. Therefore, the cable needs to have a shielding layer, and the shielding layer is driven by a voltage follower rather than directly grounded, in order to suppress common-mode interference signals brought by strong magnetic fields to the wires. The configuration cost of the LED component is low, and it is easier to control and safer than introducing lasers. The control module in the host can be implemented 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 component to emit near-infrared light.

[0037] In some embodiments, the light source unit 201 includes a light emitter, and the photostimulation module 200 further includes a light transmission element 203 connected to the light emitter. The light emitter is configured to contain ferromagnetic material and is located away from the wearing side of the magnetic stimulation coil 101. The light transmission element 203 is optically coupled to the diffusion component 202. The light emitter includes devices that directly emit light sources, such as lasers or LEDs, and is an active device containing ferromagnetic material. The light transmission element 203 includes optical fibers, etc., for guiding light and transmitting the light emitted by the light emitter. The light emitter needs to be located away from the wearing side of the magnetic stimulation coil 101 and away from the center of the magnetic field. Preferably, the light emitter is located at a position where the magnetic field strength is close to 0. Since the light transmission element 203 does not contain ferromagnetic material, it can be located at any position in the magnetic field strength. Its position is not specifically limited here. The light transmission element 203 can be optically coupled to the diffusion component 202 in various ways, such as, but not limited to, being disposed in the diffusion component 202.

[0038] In some embodiments, such as Figure 6The diagram shows a cross-sectional view of the flat diffuser assembly 202. Taking the light source 201 as an example, which is an LED assembly, the LED assembly is disposed on the outer periphery of the diffuser assembly 202. Other arrangements of the LED assembly have been listed above and will not be repeated here. The diffuser assembly 202 includes a body 2021. Multiple light guide points 2022 are disposed on the side of the body 2021 opposite to the emission surface 2023 of the diffuser assembly 202. The near-infrared light received by the diffuser assembly 202 is diffusely reflected by each light guide point 2022 and emitted from the emission surface 2023 to irradiate the user's head. The emission surface 2023 of the diffuser assembly 202 corresponds to the side of the photostimulation module 200 to be worn on the head. The diffuser assembly 202 can be rigid or flexible, integral or separate, flat or curved, as long as it can fit the user's head. The form of the diffuser assembly 202 is not specifically limited here. The LED component and the diffuser component 202 form a good optical coupling. The emitted near-infrared light is incident into the body 2021. The near-infrared light received by the body 2021 is diffusely reflected in all directions through various light guide points 2022 and then emitted from the emission surface 2023 to irradiate the user's head. In this configuration, the near-infrared light emitted by the LED component can be converted into a surface light source and emitted from the emission surface 2023, so that the near-infrared light can stimulate a sufficiently wide brain volume with a relatively uniform dose.

[0039] Furthermore, the manufacturing process of the light guide point 2022 adopts any one of the following: laser engraving, chemical etching, V-cut engraving, or UV screen printing.

[0040] 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 from 50% polymethyl methacrylate (PMMA) and 50% styrene (PS) as the main raw materials), etc.

[0041] 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 conform to the different contours of an individual's head, increasing the radiation efficiency of the emitted near-infrared light to the head. That is, the diffusion component 202 also serves as an adapter mechanism between the magnetic stimulation coil 101 and the head, helping the magnetic stimulation coil 101 to fit securely and comfortably close to the subject's head, and reducing optical refraction and loss in the gap between the diffusion component 202 and the head.

[0042] Furthermore, the light guide points 2022 are arranged unevenly. Through the light guide points 2022 of various densities and sizes, the emission surface 2023 of the diffusion component 202 can emit light uniformly.

[0043] Furthermore, the diffusion assembly 202 also includes a reflective portion 2024, which is disposed opposite to the emission surface 2023 and located on the side of the light guide point 2022 away from the emission surface 2023. The reflective portion 2024 is located on the opposite side of the emission surface 2023, below the light guide point 2022, and reflects the near-infrared light irradiated by the reflective portion 2024 back into the body 2021 to improve light utilization efficiency. Besides 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 into the body 2021; these will not be elaborated upon here.

[0044] In some embodiments, the reflective portion 2024 is made of a non-metallic material with high light reflectivity or a non-ferromagnetic metallic material. During use, the reflective portion 2024 of the diffusion assembly 202 is placed close to the magnetic stimulation coil 101. The reflective portion 2024 can be non-metallic to reduce the heat generated by the induced current from the changing magnetic field of the magnetic stimulation coil 101; alternatively, the reflective portion 2024 can also be made of a non-ferromagnetic metallic material, such as copper foil or silver foil, to avoid disturbing the magnetic field of the magnetic stimulation coil 101. As a metallic material, the reflective portion 2024 generates heat, which can be cooled together with the magnetic stimulation coil 101 using liquid cooling or air cooling. In some embodiments, the transcranial photomagnetic nerve modulation device 1 further includes a cooling mechanism. The magnetic stimulation coil 101 is placed 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 carry away heat, which is then carried away by the cooling medium. Alternatively, the reflector 2024 can be placed in the cooling medium, sharing the cooling medium and cooling circuit with the magnetic stimulation coil 101. In this way, a single cooling mechanism can be used to simultaneously cool the magnetic stimulation coil 101 and the photostimulation module 200, making efficient use of resources.

[0045] Furthermore, the body 2021 of the diffusion component 202 can be made of a thermal insulator, such as PC or CPI, and the emitting surface 2023 is in contact with the subject's head. In this way, the heat generated from the magnetic stimulation coil 101 and the reflector 2024 will not be transferred to the user's head, thereby avoiding burns to the user.

[0046] In some embodiments, the shape of the magnetic stimulation coil 101 is selected from one of the following: circular, elliptical, figure-eight, H-shaped, or biconical. Preferably, the magnetic stimulation coil 101 is an H-shaped coil, which can act on a deeper and wider target area.

[0047] In some embodiments, the percentage of the wearing side of the magnetic stimulation coil 101 that is blocked by the emission surface 2023 of the diffusion component 202 is greater than a predetermined threshold. Since the materials used in various parts of the body 2021 of the diffusion component 202 are non-metallic or non-ferromagnetic metallic materials, the diffusion component 202 being in a magnetic field environment does not affect the effect of photomagnetic synergistic use. Further, the predetermined threshold is not less than 10%, preferably 50%, 70%, or 100%. The greater the percentage of the wearing side of the magnetic stimulation coil 101 blocked by the emission surface 2023 of the diffusion component 202, the better the effect of photomagnetic synergistic stimulation of the relevant target area, achieving both a certain stimulation area and a deeper stimulation depth, effectively improving the therapeutic effect.

[0048] In some embodiments, the transcranial photomagnetic neuromodulation device 1 further includes a control module, which is connected to the magnetic stimulation module 100 and the photostimulation module 200 respectively, and controls the photostimulation module 200 and the magnetic stimulation module 100 to work sequentially or simultaneously. For example, when using LED components, the photostimulation module 200 can be turned off when the magnetic stimulation module 100 is working, and the magnetic stimulation module 100 can be turned off when the photostimulation module 200 is on. In this way, by controlling the photostimulation module 200 and the magnetic stimulation module 100 to work sequentially, the interference between them when using photomagnetic stimulation in synergy is reduced, further improving the safety and stability during use. For another example, if the light emitter (containing ferromagnetic metal) emits near-infrared light and the light transmission component 203 guides the light, since the light emitter is far from the magnetic field, it will not be affected by the magnetic field, and the magnetic stimulation module 100 will not be affected by the metal of the light emitter. This allows the magnetic stimulation module 100 and the photostimulation module 200 to work simultaneously, deepening the stimulation depth and effectively improving the treatment effect.

[0049] In some embodiments, the control module is further configured to: send a first control signal to the photostimulation module 200 to control the activation of the photostimulation module 200; and after a preset time has elapsed since the activation of the photostimulation module 200, send a second control signal to the magnetic stimulation module 100 to control the activation of the magnetic stimulation module 100. After the photostimulation module 200 has been activated for a certain period of time, near-infrared light stimulation may put neurons in a state that is more easily activated. In this case, controlling the activation of the magnetic stimulation module 100 can make the effect of TMS stimulation more significant and greatly improve the therapeutic effect on the target area. The preset time can be set according to the needs of treating different diseases, and can be 30s, 60s, 90s, 120s, etc., without specific limitation.

[0050] In some embodiments, the thickness of the diffusion component 202 does not exceed 10 mm. Further, the thickness of the diffusion component 202 can be 3 mm-10 mm, or even 3-7 mm, or even 3 mm-6 mm, thereby allowing the stimulation depth to reach the cerebral cortex, or even deeper layers of the cerebral cortex, such as 2 cm, 3 cm, or even deeper, during transcranial magnetic stimulation. A single H-type coil can stimulate depths greater than 6 cm, efficiently stimulating deep brain nuclei. At a stimulation intensity of 120% MT, the H-coil can still induce an overthreshold electric field 1.8 cm below the cortex. A biconical coil can effectively stimulate depths up to 6 cm, stimulating deeper brain regions beyond the cerebral cortex, such as the cerebellum, anterior cingulate cortex, and orbitofrontal lobe. The biconical coil can generate current 4-5 cm below the intersection of the two coils, thus stimulating deeper areas. Because our diffusion component 202 is very thin and makes full use of the original internal space of these magnetic stimulation coils 101 to accommodate the light source 201 and / or diffusion component 202 of the photostimulation module 200, the magnetic stimulation intensity can still reach deep into the brain when synergistically transcranial photomagnetic stimulation is performed.

[0051] In some embodiments, for users with dark and thick hair, the transcranial photomagnetic neuromodulation device 1 can also be used in conjunction with a light guide comb. When the user wears the light guide comb, the hair can be parted to form an optical path for near-infrared light (e.g., the light-transmitting part of the light guide comb - the scalp with sparse hair and full exposure under the light-transmitting part - the skull under the scalp). 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, making it less likely for heat to be transferred to the scalp.

[0052] In some embodiments, the light guide comb can be integrated into the diffusion component 202. When wearing the device, the light guide comb is worn directly, the user's hair is parted from the front, the diffusion component 202 is positioned, and then the magnetic stimulation coil 101 is worn. The magnetic stimulation coil 101 is positioned relative to the subject's head, which can perform photomagnetic synergistic modulation, which is convenient to use and improves the treatment effect.

[0053] This invention provides a transcranial photomagnetic neuromodulation device 1. The device correspondingly sets up a photostimulation module 200 and a magnetic stimulation module 100, and places a diffusion component 202 of the photostimulation module 200 on the wearing side of the magnetic stimulation coil 101 in the magnetic stimulation module 100. This allows the relatively thin diffusion component 202 to be positioned 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 the light source 201 in the photostimulation module 200 and diffuses the near-infrared light. The diffused near-infrared light is emitted through the diffusion component 202. The light emitted from the light source 2023 irradiates the user's head, ensuring that the near-infrared light emitted by the light source 201 is diffused by the diffusion component 202, covering most of the brain regions as comprehensively as possible. When used in conjunction with the magnetic stimulation coil 101, the stimulated brain volume is sufficiently extensive. At the same time, the light source 201 is positioned where the magnetic field strength of the magnetic stimulation coil 101 is less than a first threshold, significantly reducing the interference between the light stimulation module 200 and the magnetic stimulation module 100 during use. This transcranial photomagnetic neuromodulation device 1 can combine TMS and near-infrared light irradiation capabilities, effectively coordinating photomagnetic modulation of the target brain region in both the temporal and spatial domains.

[0054] The transcranial photomagnetic neuromodulation device 1 provided in this application can effectively stimulate a sufficiently large brain volume and a deeper subcortical area through photomagnetic synergy, thereby effectively improving the treatment effect.

[0055] Furthermore, although exemplary embodiments have been described herein, their scope includes any and all embodiments based on the invention that have equivalent elements, modifications, omissions, combinations (e.g., schemes involving intersections of various embodiments), adaptations, or alterations. Elements in the claims will be interpreted broadly based on the language used in the claims and are not limited to the examples described in this specification or during the implementation of this application, and such examples will be interpreted as non-exclusive. Therefore, this specification and examples are intended to be considered illustrative only, and the true scope and spirit are indicated by the appended claims and their equivalents in their entirety.

[0056] The above description is intended to be illustrative and not restrictive. For example, the above examples (or one or more of them) can be used in combination with each other. Other embodiments may be used by those skilled in the art upon reading the above description. Furthermore, in the above detailed description, various features may be grouped together to simplify the invention. This should not be construed as an intention that a disclosed feature, which is not claimed, is necessary for any claim. Rather, the subject matter of the invention may be less than all the features of the particular disclosed embodiments. Thus, the appended claims are incorporated herein by reference as examples or embodiments, wherein each claim is an independent, separate embodiment, and these embodiments are contemplated as being possible in various combinations or arrangements with each other. The scope of the invention should be determined by reference to the appended claims and the full scope of their equivalents.

[0057] The above embodiments are merely exemplary embodiments of the present invention and are not intended to limit the present invention. The scope of protection of the present invention is defined by the claims. Those skilled in the art can make various modifications or equivalent substitutions to the present invention within its spirit and scope of protection, and such modifications or equivalent substitutions should also be considered to fall within the scope of protection of the present invention.

Claims

1. A transcranial optomagnetic neuromodulation device, characterized in that, The transcranial magnetic stimulation and transcranial near-infrared light stimulation in the transcranial photomagnetic neuromodulation device are both used to regulate the function of the nervous system. The transcranial photomagnetic neuromodulation device includes: A magnetic stimulation module, which includes a magnetic stimulation coil for applying transcranial magnetic stimulation; A photostimulation module, corresponding to the magnetic stimulation module, includes a light source and a diffusion assembly. The light source emits near-infrared light, and the diffusion assembly is located on the wearing side of the magnetic stimulation coil. The diffusion assembly receives the near-infrared light from the light source and diffuses it. The diffused near-infrared light exits through the exit surface of the diffusion assembly to irradiate the user's head. The light source is positioned where the magnetic field strength is less than the first threshold.

2. The transcranial optomagnetic neuromodulation device according to claim 1, characterized in that, The transcranial photomagnetic neuromodulation device is used to treat Alzheimer's disease or mild cognitive impairment.

3. The transcranial optomagnetic neuromodulation device according to claim 1, characterized in that, The first threshold is no greater than 2T.

4. The transcranial optomagnetic neuromodulation device according to claim 1, characterized in that, The light source is positioned where the magnetic field strength is less than a first threshold to reduce interference between the light stimulation module and the magnetic stimulation module.

5. The transcranial optomagnetic neuromodulation device according to claim 1, characterized in that, The light source portion is partially disposed relative to the diffusion assembly; and / or, the diffusion assembly is a continuous sheet.

6. The transcranial optomagnetic neuromodulation device according to claim 1, characterized in that, The number of diffusion components is less than the number of light sources.

7. The transcranial optomagnetic neuromodulation device according to any one of claims 1 to 6, characterized in that, The magnetic stimulation module further includes a housing disposed outside the magnetic stimulation coil, and the diffusion component is disposed on the wearing side of the housing. The diffusion component is constructed in one of the following ways: The diffusion component is disposed outside the housing, either separately from or closely attached to the housing; The diffusion component is disposed within the housing, which has a light-transmitting wearing surface that is configured as the emission surface of the diffusion component.

8. The transcranial optomagnetic neuromodulation device according to any one of claims 1 to 6, characterized in that, The magnetic stimulation coil has a cavity, and the light source and / or the light transmission component connected to the light source are disposed corresponding to the cavity. The emission surface of the diffusion component is disposed on the wearing side of the magnetic stimulation coil.

9. The transcranial optomagnetic neuromodulation device according to claim 8, characterized in that, The light source is configured using the cavity of the magnetic stimulation coil, or the diffusion assembly has a hole corresponding to the position of the cavity, and the light source is configured using the hole formed by the diffusion assembly; or The diffusion component has a hole corresponding to the position of the cavity. The light transmission element passes through the cavity of the magnetic stimulation coil and enters the hole of the diffusion component to be optically coupled to the diffusion component to transmit near-infrared light from the distant light source.

10. The transcranial optomagnetic neuromodulation device according to any one of claims 1 to 6, characterized in that, The light source is positioned both laterally and longitudinally away from the center of the magnetic stimulation coil; and / or The light source is disposed in the cavity or outer peripheral space of the magnetic stimulation coil; and / or The light source is disposed in the hole or peripheral space of the diffusion assembly; and / or The light source and / or the diffusion assembly are housed within the original internal space of the magnetic stimulation coil.

11. The transcranial optomagnetic neuromodulation device according to any one of claims 1 to 6, characterized in that, The light source includes an LED assembly disposed on the inner and / or outer peripheral sides of the diffusion assembly, and the LED assembly is configured not to contain ferromagnetic material.

12. The transcranial optomagnetic neuromodulation device according to any one of claims 1 to 6, characterized in that, The light source includes a light emitter, and the photostimulation module further includes a light transmission element connected to the light emitter. The light emitter is configured to contain a ferromagnetic material and is located away from the wearing side of the magnetic stimulation coil. The light transmission element is optically coupled to the diffusion assembly.

13. The transcranial optomagnetic neuromodulation device according to any one of claims 1 to 6, characterized in that, The diffusion component includes a body, and a plurality of light guide points are provided on one side of the body opposite to the emission 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 emission surface to irradiate the user's head.

14. The transcranial optomagnetic neuromodulation device according to claim 13, characterized in that, The light guide points are arranged unevenly.

15. The transcranial optomagnetic neuromodulation device according to claim 13, characterized in that, The diffusion component further includes a reflective portion, which is disposed opposite to the emission surface and located on the side of the light guide point away from the emission surface.

16. The transcranial optomagnetic neuromodulation device according to any one of claims 1 to 6, characterized in that, The shape of the magnetic stimulation coil is selected from one of the following: circular, elliptical, figure-eight, H-shaped, or biconical.

17. The transcranial optomagnetic neuromodulation device according to any one of claims 1 to 6, characterized in that, The ratio at which the wearing side of the magnetic stimulation coil is blocked by the emission surface of the diffusion component is greater than a predetermined threshold.

18. The transcranial optomagnetic neuromodulation device according to claim 13, characterized in that, The light guide point is manufactured using any one of the following methods: laser engraving, chemical etching, V-cut engraving, or UV screen printing.

19. The transcranial optomagnetic neuromodulation device according to claim 15, characterized in that, The transcranial photomagnetic neuromodulation device also includes a cooling mechanism, wherein the magnetic stimulation coil is disposed in the cooling medium supplied by the cooling mechanism, and the reflective part is close to the magnetic stimulation coil.

20. The transcranial optomagnetic neuromodulation device according to claim 15, characterized in that, The reflective part is made of a non-metallic material with high light reflectivity or a non-ferromagnetic metallic material.

21. The transcranial optomagnetic neuromodulation device according to any one of claims 1 to 6, characterized in that, At least a portion of the diffusion component is made of a flexible material to fit the user's head contour.

22. The transcranial optomagnetic neuromodulation device according to any one of claims 1 to 6, characterized in that, The transcranial optomagnetic neuromodulation device also includes a control module, which is connected to the magnetic stimulation module and the optostimulation module respectively, and controls the optostimulation module and the magnetic stimulation module to work sequentially or simultaneously.

23. The transcranial optomagnetic neuromodulation device according to claim 22, characterized in that, in, The control module is further configured to: A first control signal is sent to the photostimulation module to control the photostimulation module to start. After a preset time has elapsed since the photostimulation module started, a second control signal is sent to the magnetic stimulation module to control the magnetic stimulation module to start.

24. The transcranial optomagnetic neuromodulation device according to any one of claims 1 to 6, characterized in that, The thickness of the diffusion component does not exceed 10 mm.

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