A transcranial ultrasound stimulation device

Abstract

The utility model discloses a kind of transcranial ultrasound stimulation devices, it is related to medical instrument and ultrasonic treatment technical field, comprising: ultrasonic transducer;Tightening assembly, it is set to the bottom outside of ultrasonic transducer, and the quick disassembly and installation of ultrasonic transducer are realized by tightening assembly;Ultrasonic coupling assembly, it is set to the bottom of tightening assembly and is matched with ultrasonic transducer, and by ultrasonic coupling assembly, air gap when fitting is reduced to reduce sound energy loss.The utility model is matched by ultrasonic transducer, tightening assembly and ultrasonic coupling assembly, not only can realize accurate ultrasonic wave conduction, can also adapt to complex head shape, especially at complex target point such as binaural area, the flexible characteristic of its soft bag guarantees close fitting with head tissue, so that it can provide consistent sound wave conduction, avoid the interference of air or other material, significantly improve the effect of treatment.

Description

Technical Field

[0001] This utility model relates to the field of medical devices and ultrasound therapy technology, specifically to a transcranial ultrasound stimulation device. Background Technology

[0002] Currently, common modulation techniques for neurological diseases include transcranial direct current stimulation, transcranial magnetic stimulation, deep brain stimulation, photogene therapy, and transcranial ultrasound stimulation. While transcranial electrical stimulation and transcranial magnetic stimulation are widely used for neurological and psychiatric diseases such as depression and Parkinson's disease, they have drawbacks such as low spatial resolution and shallow stimulation depth. Deep brain stimulation has high spatial resolution, but as an invasive procedure, it carries risks such as intraoperative nerve cell and tissue damage and postoperative infection. Photogene therapy, as an emerging technique, offers high stimulation precision, but it requires highly advanced gene technology.

[0003] Transcranial ultrasound stimulation (TUS) is a novel method of neuromodulation with advantages such as non-invasiveness, high resolution, and high penetration depth. Its mechanism of action involves directly modulating neural activity through mechanical waves. The low intensity of the ultrasound used results in almost no thermal effect, causing no damage to cells and tissues in the stimulated area. Secondly, the short wavelength of ultrasound waves allows TUS to achieve a low spatial resolution of approximately 2-5 mm. Furthermore, the transducer can be designed to stimulate depths up to 15 cm, enabling effective stimulation of deeper brain regions. Finally, TUS offers excellent compatibility. Because ultrasound waves are mechanical, no external magnetic or electric field is required, allowing simultaneous imaging with functional magnetic resonance imaging (fMRI). This greatly aids in the precise localization of brain target stimulation points and the study of neural function.

[0004] However, due to the acoustic impedance mismatch between the ultrasound transducer, air, and scalp, the gap between the ultrasound transducer and the scalp needs to be filled with a coupling medium that matches the acoustic impedance to reduce the loss during ultrasound propagation. Traditional ultrasound diagnostic and therapeutic transducers can be coupled to the tested object by applying an ultrasound coupling agent. For transcranial ultrasound transducers, due to the curved shape and irregularity of the skull, the coupling agent alone is insufficient to fill the gap between the ultrasound transducer and the scalp. A coupling device must exist between the transducer and the scalp.

[0005] Existing coupling devices used with ultrasound transducers have the following drawbacks: Due to the large coupling area or differences in transmission angle between the ultrasound transducer array surface and the skull, the coupling device cannot fit snugly against the skull tissue, resulting in significant sound energy transmission loss. Furthermore, the focal length of the coupling device is not adjustable, failing to meet the stimulation requirements of different skull thicknesses and treatment depths. Secondly, the coupling device cannot dynamically adjust the contact pressure with the head, making it difficult to reach the treatment target due to limitations imposed by complex target areas (ear and face regions). Finally, the installation of the coupling components is cumbersome, increasing treatment preparation time and operational difficulty.

[0006] Therefore, there is an urgent need in the field to develop a transcranial ultrasound stimulation device for the human body. This ultrasound transducer and coupling assembly can overcome the shortcomings of the prior art, perfectly fit the cranial tissue, and meet the target treatment needs of different depths in the brain region.

[0007] No effective solutions have yet been proposed to address the problems in the relevant technologies. Utility Model Content

[0008] In view of the problems in the related technologies, this utility model proposes a transcranial ultrasound stimulation device to overcome the above-mentioned technical problems existing in the existing related technologies.

[0009] Therefore, the specific technical solution adopted by this utility model is as follows:

[0010] According to one aspect of the present invention, a transcranial ultrasound stimulation device is provided, comprising:

[0011] An ultrasonic transducer; a tightening assembly located on the bottom outer side of the ultrasonic transducer, which enables quick disassembly and installation of the ultrasonic transducer; and an ultrasonic coupling assembly located at the bottom of the tightening assembly and cooperating with the ultrasonic transducer, which reduces the air gap during contact to reduce sound energy loss.

[0012] Furthermore, the tightening assembly includes a locking cover located on the outer side of the bottom of the ultrasonic transducer. The locking cover has a ring-shaped structure, and the inner top of the locking cover has several sliding grooves with an L-shaped structure. The inner bottom of the locking cover has a connecting platform that cooperates with the ultrasonic coupling assembly, and the connecting platform has a ring-shaped structure.

[0013] Furthermore, the slide includes several guide grooves formed on the top of the lock cover, and an anti-disengagement groove connected to the bottom side of the guide groove is provided therewith. An arc-shaped guide surface is provided at the connection between the top of the guide groove and the anti-disengagement groove.

[0014] Furthermore, the bottom outer side of the ultrasonic transducer is provided with several locking blocks that cooperate with the sliding groove, and the top of the locking blocks is provided with an arc-shaped transition surface that cooperates with the arc-shaped guide surface.

[0015] Furthermore, the ultrasonic coupling assembly includes a coupling pad disposed at the bottom of the tightening assembly, and a soft pouch is disposed on the outside of the coupling pad.

[0016] Furthermore, the coupling pad includes a cylindrical coupling block disposed inside the connecting platform, and the top of the cylindrical coupling block has an arc-shaped protrusion that matches the bottom of the ultrasonic transducer. An annular sealing block that matches the locking cover is disposed on the outer side of the top of the cylindrical coupling block and at the top of the connecting platform.

[0017] Furthermore, the soft capsule is a solid or hollow structure. The soft capsule includes an annular connecting section located outside the connecting groove on the bottom outer side of the cylindrical coupling block or on the bottom outer side of the lock cover. The bottom end of the annular connecting section is provided with a circular fitting section. The annular connecting section and the circular fitting section are connected by a deformation transition section, which is one of an arc-shaped structure, a corrugated structure, a pleated structure, or a spiral structure.

[0018] Furthermore, when the soft capsule is a hollow structure, the soft capsule also includes an injection platform and an injection tank; several injection platforms are disposed on the outside of the soft capsule, and the injection tank is opened on one side of the injection platform, and the injection tank is connected to the soft capsule; the cavity formed by the soft capsule is filled with ultrasonic coupling agent through the injection tank.

[0019] Furthermore, when the soft capsule is a hollow structure, the tightening assembly also includes through holes; several through holes are opened at the top of the locking cover, and the through holes are configured to cooperate with the ultrasonic coupling assembly, and the through holes are connected to the cavity inside the soft capsule; ultrasonic coupling agent is filled into the cavity formed by the soft capsule through the through holes.

[0020] The beneficial effects of this utility model are as follows:

[0021] 1. This utility model, through the coordinated arrangement of an ultrasonic transducer, a tightening assembly, and an ultrasonic coupling assembly, not only achieves precise ultrasonic wave transmission but also adapts to complex head shapes. Especially in complex target areas such as the bilateral ear region, the flexible nature of its soft capsule ensures a close fit with the cranial tissue, enabling it to provide consistent sound wave transmission and avoid interference from air or other substances. This significantly improves the treatment effect, enhances the versatility and adaptability of the device, and allows the device to focus on treatments covering areas such as the deep brain, mid-cranial region, and superficial intracranial layer. Furthermore, the corresponding ultrasonic coupling assembly can be installed to adjust the focal length according to different treatment needs, improving the multi-target treatment functionality of the ultrasonic transducer.

[0022] 2. This invention, through an ultrasound coupling component, can adjust the focal length according to the specific conditions of different patients (such as skull thickness, treatment depth, etc.). By changing the ultrasound focusing point, it ensures that the ultrasound can accurately act on the target brain region. In addition, the ultrasound coupling component also has the function of closely fitting the scalp, ensuring perfect fit even in complex target areas, reducing air gaps, reducing sound energy loss, and preventing the ultrasound beam from deviating from the normal incident line into the skull, which would lead to attenuation of transmitted energy, thereby improving the transmission efficiency of ultrasound and thus improving the treatment effect. Attached Figure Description

[0023] To more clearly illustrate the technical solutions in the embodiments of this utility model or the prior art, the drawings used in the embodiments will be briefly introduced below. Obviously, the drawings described below are only some embodiments of this utility model. For those skilled in the art, other drawings can be obtained based on these drawings without creative effort.

[0024] Figure 1 This is a structural schematic diagram according to Embodiment 1 of the present utility model;

[0025] Figure 2 This is a three-dimensional assembly drawing based on Embodiment 1 of this utility model;

[0026] Figure 3 This is a partial structural schematic diagram according to an embodiment of the present utility model;

[0027] Figure 4 This is one of the cross-sectional views of the tightening assembly and the ultrasonic coupling assembly according to Embodiment 1 of this utility model;

[0028] Figure 5 This is a partial cross-sectional view of the tightening assembly and the ultrasonic coupling assembly according to Embodiment 1 of this utility model;

[0029] Figure 6 This is a second cross-sectional view of the tightening assembly and the ultrasonic coupling assembly in Embodiment 2 of this utility model;

[0030] Figure 7 This is a cross-sectional view of the tightening assembly according to Embodiment 2 of this utility model;

[0031] Figure 8 This is a structural schematic diagram of Embodiment 1 of the present invention in practical application;

[0032] Figure 9 This is a schematic diagram showing the fit of the tightening component and the ultrasonic coupling component with the curved surface of the skull in different treatment areas during actual application according to Embodiment 1 of this utility model;

[0033] Figure 10This is a structural schematic diagram of Embodiment 3 of this utility model in practical application;

[0034] Figure 11 This is a structural schematic diagram of another installation method according to Embodiment 4 of this utility model in actual application;

[0035] Figure 12 This is a structural schematic diagram of another installation method according to Embodiment 5 of this utility model in actual application;

[0036] Figure 13 It is a focal acoustic intensity diagram obtained from the simulation of the ultrasonic transducer in the embodiment of this utility model;

[0037] Figure 14 The diagram is based on the axial sound pressure level obtained from the simulation of the ultrasonic transducer in the embodiments of this utility model.

[0038] Figure 15 The ultrasonic transducer focal intensity diagram is obtained by measuring the hydrophone in the embodiment of this utility model.

[0039] Figure 16 The axial normalized diagram of the ultrasonic transducer is obtained from the hydrophone in the embodiment of this utility model.

[0040] Figure 17 These are structural schematic diagrams of different specifications of coupling pads according to embodiments of this utility model;

[0041] Figure 18 This is one of the simulation diagrams of the adjustable focal length transcranial ultrasound stimulation device according to the embodiments of this utility model;

[0042] Figure 19 This is the second simulation diagram of the adjustable focal length transcranial ultrasound stimulation device according to the embodiments of this utility model;

[0043] Figure 20 It is a curve fitted according to the focal length reduction value corresponding to different sound velocities and thickness coupling pads in the embodiments of this utility model.

[0044] In the picture:

[0045] 1. Ultrasonic transducer; 2. Tightening assembly; 201. Locking cap; 202. Slide groove; 2021. Guide groove; 2022. Anti-detachment groove; 2023. Arc-shaped guide surface; 203. Connecting platform; 204. Connecting groove; 205. Through hole; 3. Ultrasonic coupling assembly; 301. Coupling pad; 3011. Cylindrical coupling block; 3012. Arc-shaped raised surface; 3013. Annular sealing block; 302. Soft capsule; 3021. Annular connecting section; 3022. Circular fitting section; 3023. Deformation transition section; 303. Injection platform; 304. Injection groove; 4. Locking block; 5. Arc-shaped transition surface; 6. Patient's brain. Detailed Implementation

[0046] To further illustrate the various embodiments, the present invention provides accompanying drawings, which are part of the disclosure of the present invention. These drawings are mainly used to illustrate the embodiments and can be used in conjunction with the relevant descriptions in the specification to explain the operating principles of the embodiments. With reference to these contents, those skilled in the art should be able to understand other possible implementation methods and the advantages of the present invention. The components in the figures are not drawn to scale, and similar component symbols are usually used to represent similar components.

[0047] According to an embodiment of the present invention, a transcranial ultrasound stimulation device is provided.

[0048] The present invention will now be further described in conjunction with the accompanying drawings and specific embodiments.

[0049] Example 1

[0050] like Figures 1-5 As shown, according to one embodiment of the present invention, a transcranial ultrasound stimulation device is provided, comprising:

[0051] Ultrasonic transducer 1; tightening assembly 2, located on the bottom outer side of ultrasonic transducer 1, and enabling quick disassembly and installation of ultrasonic transducer 1 through tightening assembly 2; ultrasonic coupling assembly 3, located at the bottom of tightening assembly 2 and cooperating with ultrasonic transducer 1, and reducing sound energy loss by reducing air gap during contact through ultrasonic coupling assembly 3.

[0052] It should be noted that the ultrasonic transducer 1 is a focused or non-focused transducer. The ultrasonic transducer 1 has a handle structure in its external design, and the lower end of the handle has a connector.

[0053] Specifically, the tightening assembly 2 includes a locking cover 201 located on the outer side of the bottom of the ultrasonic transducer 1. The locking cover 201 has an annular structure. Several sliding grooves 202 are provided on the inner top of the locking cover 201. The sliding grooves 202 have an L-shaped structure. A connecting platform 203 that cooperates with the ultrasonic coupling assembly 3 is provided on the inner bottom of the locking cover 201. The connecting platform 203 has an annular structure.

[0054] Specifically, the slide 202 includes several guide grooves 2021 formed at the top of the lock cover 201. A non-detachment groove 2022 is provided on one side of the bottom of the guide groove 2021 and communicates with it. An arc-shaped guide surface 2023 is provided at the connection between the top of the guide groove 2021 and the non-detachment groove 2022.

[0055] Specifically, the bottom outer side of the ultrasonic transducer 1 is provided with several locking blocks 4 that cooperate with the sliding groove 202, and the top of the locking block 4 is provided with an arc-shaped transition surface 5 that cooperates with the arc-shaped guide surface 2023.

[0056] Specifically, the ultrasonic coupling assembly 3 includes a coupling pad 301 disposed at the bottom of the tightening assembly 2, and a soft pouch 302 disposed on the outside of the coupling pad 301.

[0057] Specifically, the coupling pad 301 includes a cylindrical coupling block 3011 disposed inside the connecting platform 203, and the top of the cylindrical coupling block 3011 is provided with an arc-shaped protrusion 3012 that cooperates with the bottom of the ultrasonic transducer 1. An annular sealing block 3013 that cooperates with the locking cover 201 is disposed on the outer side of the top of the cylindrical coupling block 3011 and at the top of the connecting platform 203.

[0058] It should be noted that the arc-shaped protrusion 3012 conformally matches and can be tightly fitted with the vibrating element surface of the ultrasonic transducer 1.

[0059] It should be noted that the focal length of the ultrasonic transducer 1 can be adjusted according to the different materials and thicknesses of the coupling pad 301. The focal length of the ultrasonic transducer 1 can be adjusted according to the sound velocity C (m / s) and thickness H (mm) of the coupling pad 301. Specifically, the focal length reduction value ΔF (mm) of the ultrasonic transducer 1 can be calculated, and the thickness H of the coupling pad 301 or the material with different sound velocities C can be adjusted according to the target ΔF value.

[0060] The formula for calculating the focal length reduction ΔF is as follows:

[0061] ΔF = K1 − K2 * H − K3 * C − K4 * H 2 +K5*H*C;

[0062] In the formula, ΔF represents the reduction in focal length of ultrasonic transducer 1; K1 represents a constant coefficient, and K1=85.036±5%; K2 represents the first-order coefficient of thickness H, K2=0.1752±5%; K3 represents the first-order coefficient of sound velocity C, K3=0.0556±5%; K4 represents the squared-term coefficient of thickness H, K4=0.0032±5%; K5 represents the cross-term coefficient of thickness H and sound velocity C, K5=0.001±5%; H represents the thickness of coupling pad 301; and C represents the sound velocity of coupling pad 301.

[0063] Wherein, according to the given formula:

[0064] ΔF=85.036-0.1752*H-0.0556*C-0.0032*H 2 +0.001*H*C;

[0065] The ΔF value can be calculated when the thickness H of the coupling pad 301 is 10mm, 15mm, 20mm and 25mm, and the sound velocity C of the coupling pad 301 is 1500m / s, 1400m / s, 1300m / s, 1200m / s and 1100m / s, respectively; for example, when the thickness H of the coupling pad 301 is 10mm and the sound velocity is 1500m / s, the ΔF value is 14.2.

[0066] In special cases, the thickness of the coupling pad 301 can be very small. In this case, the coupling pad 301 takes the form of a thin film. The coupling pad 301 has almost no effect on the focal length of the ultrasonic transducer 1. The coupling pad 301 only plays the role of ultrasonic coupling.

[0067] Specifically, the soft capsule 302 is a solid structure. The soft capsule 302 includes an annular connecting section 3021 located outside the connecting groove 204 on the outer side of the bottom of the lock cover 201. A circular fitting section 3022 is provided at the bottom end of the annular connecting section 3021. The annular connecting section 3021 and the circular fitting section 3022 are connected by a deformation transition section 3023, which is one of an arc-shaped structure, a corrugated structure, a pleated structure, or a spiral structure.

[0068] It should be noted that the soft capsule 302 can be deformed according to the shape of the skull and fits tightly to the skull; and the thickness of the bonding surface of the soft capsule 302 is 1-3mm, the thickness of the lower base is 0.5-1mm, and the slope of the wall thickness transition zone is 1:2-1:8.

[0069] like Figure 2 As shown, the locking cover 201 of the tightening assembly 2 can be connected to coupling pads 301 of different specifications. The soft capsule 302 is connected and covered around the outer periphery of the locking cover 201. The connection method can be achieved by bonding, secondary injection molding, or encapsulation. The ultrasonic transducer 1 has evenly distributed locking blocks 4 on its outer side. The inner ring of the locking cover 201 has L-shaped sliding grooves 202, with three sliding grooves 202 evenly distributed inside the ring. The L-shaped sliding grooves 202 are adapted to the locking blocks 4 to ensure that the ultrasonic transducer 1 can be smoothly guided and limited when sliding in the sliding grooves 202. Located within the anti-detachment groove 2022, the curved vibrating element surface of the ultrasonic transducer 1 is tightly fitted with the arc-shaped protrusion 3012 of the coupling pad 301, ensuring that the ultrasonic signal can be transmitted uniformly through the coupling pad 301. The arc-shaped transition surface 5, in conjunction with the arc-shaped guide surface 2023 of the slide groove 202, ensures that the locking block 4 rotates clockwise and slides into the anti-detachment groove 2022 of the transverse structure. The rotating installation of the locking block 4 and the slide groove 202 maintains the stability of the ultrasonic treatment head of the ultrasonic transducer 1 during the treatment process, avoiding positional displacement caused by external interference.

[0070] like Figure 3As shown, the ultrasonic transducer 1 consists of a handle, a cylindrical body, a curvature vibrating element surface, and a connector. The handle surface can be provided with anti-slip textures, such as straight lines, waves, diamond grids, dotted protrusions, or cross grids. The structural design conforms to ergonomic hand grip and is also compatible with universal brackets and robotic arms for clamping, which is more conducive to long-term treatment fixation. The connection between the handle and the cylindrical body has a transition angle to stably support the transducer. Three evenly distributed locking blocks 4 can be set on the outer side of the cylinder. The locking blocks 4 can be screwed into the sliding groove 202 to prevent loosening or displacement during use, ensuring the precise positioning and stable operation of the transducer. The design with the curvature vibrating element surface can concentrate sound wave energy and improve the treatment effect. The curvature vibrating element surface can perfectly conform to the arc-shaped protrusion surface 3012. The connector needs to be connected to the ultrasonic transmitting device to generate sound pressure output. The connector design takes into account the stability and durability of the transducer to ensure that the cable will not loosen during long-term operation.

[0071] like Figure 4 As shown, the tightening assembly 2 is used to connect the ultrasonic transducer 1 to the ultrasonic coupling assembly 3 and provides stable support; the evenly distributed L-shaped grooves 202 on the inner wall of the locking cover 201 are used for docking and fixing with the outer locking block 4 of the ultrasonic transducer 1. The outer shell of the locking cover 201 is made of high-strength plastic material (PC, POM, PET, PA or ABS, etc.) by injection molding to ensure that it will not deform or crack during long-term use; the coupling pad 301 is preferably made of silicone, rubber, epoxy or polyurethane adhesive with a hardness range of HA0-HA20. The function of the coupling pad 301 is to seal, adjust the focal length and conduct ultrasonic energy. The design of the upper arc-shaped protrusion 3012 matches the curvature element surface of the bottom of the ultrasonic transducer 1. The coupling pad 301 is bonded, secondary injection molded or overmolded with the top of the connecting platform 203 and the inner wall of the locking cover 201. The annular sealing block 3013 is integrated with the connecting platform 203 and the inner wall of the locking cover 201. The outer periphery of the annular sealing block 3013 fits against the inner side of the tightening assembly 2 to ensure sealing and prevent loosening or fluid leakage during treatment. The soft capsule is preferably made of low-hardness (HA0-HA20) silicone, rubber, epoxy, or polyurethane. The soft capsule 302 can be mechanically snapped, embedded, hot-pressed, ultrasonically welded, or chemically bonded. For example, it can be integrated with the connecting groove 204 by quick-drying adhesive. The wall thickness of the soft capsule 302 gradually decreases. The thicker wall of the contact surface between the soft capsule 302 and the connecting groove 204 also utilizes the material's resilience to fit tightly against the outer side of the locking cover 201, ensuring the internal sealing of the soft capsule 302. In this embodiment, the deformation transition section 3023 at the lower end of the soft capsule 302 allows it to better deform and stretch to fit the curved surface of the skull.

[0072] It should be noted that in practical applications, the ultrasound coupling component 3 is fitted to the patient's brain 6.

[0073] like Figure 8 As shown, ultrasound waves of a specific frequency and intensity emitted by the ultrasound transducer 1 are transmitted through the ultrasound coupling assembly 3 to the target point in the patient's brain 6 for neurostimulation therapy. The ultrasound waves emitted by the ultrasound transducer 1 are characterized by low intensity and high spatial resolution, enabling direct modulation of brain neural activity without causing thermal effects. This transcranial ultrasound stimulation device is designed with an adjustable focal length, which can be adjusted according to the specific conditions of different patients (such as skull thickness and treatment depth). By changing the ultrasound focusing point, it ensures that the ultrasound waves can accurately act on the target brain region. Furthermore, the coupler has the function of close contact with the scalp, ensuring perfect fit even in complex target areas, reducing air gaps, lowering sound energy loss, and improving ultrasound transmission efficiency.

[0074] like Figure 9 The diagram illustrates a specific implementation of the transcranial ultrasound stimulation device in the head region, focusing on the positioning of the ultrasound coupler at different treatment targets on the skull. The diagram shows that the ultrasound coupling component 3 perfectly conforms to the skull, avoiding air gaps at the propagation interface, allowing ultrasound waves to be transmitted to the target treatment area. The fluid-like coupling agent inside the ultrasound coupling component 3 ensures the distance between it and the scalp, allowing the soft capsule 302 to adhere to the scalp, preventing the ultrasound beam from deviating from its normal incidence into the skull and causing attenuation of transmitted energy, thereby improving the treatment effect.

[0075] Example 2

[0076] like Figures 6-7 As shown, this embodiment of a transcranial ultrasound stimulation device is based on Embodiment 1:

[0077] Specifically, the soft capsule 302 has a hollow structure, and the tightening assembly 2 also includes a through hole 205; several through holes 205 are opened at the top of the locking cover 201, and the through holes 205 are configured to cooperate with the ultrasonic coupling assembly 3, and the through holes 205 are connected to the cavity inside the soft capsule 302; ultrasonic coupling agent is filled into the cavity formed by the soft capsule 302 through the through holes 205.

[0078] It should be noted that the coupling pad 301 and the soft capsule 302 are made of the same or different materials, and the cavity formed between the coupling pad 301 and the soft capsule 302 needs to be filled with a fluid ultrasonic coupling agent through the through hole 205. The fluid ultrasonic coupling agent can be degassed water, glycerol, ethylene glycol, glycerol and commercial coupling agents, or a solution of these different components in different proportions.

[0079] It should be noted that after the tightening component 2 and the ultrasonic coupling component 3 are formed into one piece, a fluid coupling agent is injected through the through hole 205 on the upper end face of the locking cover 201. Air is vented while injecting. After injection, the through hole 205 is sealed with glue. There may be one or several through holes 205. The design and function of each part complement each other to ensure the sealing, stability and functionality in actual use.

[0080] It should be noted that in this embodiment, the coupling pad 301 and the soft capsule 302 are two different components installed. After the coupling pad 301 and the soft capsule 302 are connected to the locking cover 201 respectively, the interior is sealed into a cavity, which is filled with a fluid ultrasonic coupling agent.

[0081] Example 3

[0082] like Figure 10 As shown, this embodiment of a transcranial ultrasound stimulation device is based on Embodiment 1:

[0083] Specifically, the soft capsule 302 is a hollow structure, and the soft capsule 302 also includes an injection platform 303 and an injection groove 304; a plurality of injection platforms 303 are disposed on the outside of the soft capsule 302, and the injection groove 304 is opened on one side of the injection platform 303, and the injection groove 304 is connected to the soft capsule 302; the cavity formed by the soft capsule 302 is filled with ultrasonic coupling agent through the injection groove 304.

[0084] Example 4

[0085] like Figure 11 As shown, the transcranial ultrasound stimulation device of this embodiment differs from that of Embodiment 1 in that: the soft capsule 302 includes an annular connecting section 3021 disposed on the outer side of the bottom of the cylindrical coupling block 3011; the soft capsule 302 and the coupling pad 301 can be made of materials with different hardness, and the coupling pad 301 and the soft capsule 302 are made as one piece. The soft capsule 302 completely wraps the outer side of the bottom of the coupling pad 301 through the circular fitting section 3022 on the upper end face. There is no cavity inside the soft capsule 302 and the coupling pad 301. The circular fitting section 3022 at the lower end base has particularly high flexibility and deformation ability to conform to the curved surface of the skull.

[0086] Example 5

[0087] like Figure 12 As shown, this embodiment of a transcranial ultrasound stimulation device is based on embodiment four:

[0088] Specifically, the soft capsule 302 is a hollow structure, and the soft capsule 302 also includes an injection platform 303 and an injection groove 304; a plurality of injection platforms 303 are disposed on the outside of the soft capsule 302, and the injection groove 304 is opened on one side of the injection platform 303, and the injection groove 304 is connected to the soft capsule 302; the cavity formed by the soft capsule 302 is filled with ultrasonic coupling agent through the injection groove 304.

[0089] It should be noted that the soft capsule 302 and the coupling pad 301 are bonded and covered as a whole. After the coupling pad 301 and the soft capsule 302 are made into one piece, a sealed cavity is formed between the soft capsule 302 and the coupling pad 301. The injection stage 303 on the outside of the soft capsule 302 is designed to utilize the elasticity of the material, which facilitates the injection of the flowing coupling agent after the syringe or injection needle is aspirated. After the injection is completed, the injection groove 304 is glued to improve its sealing performance. The circular fitting section 3022 of the lower base ensures close contact between the injection and the treatment area.

[0090] To facilitate understanding of the above-mentioned technical solutions of this utility model, the working principle or operation method of this utility model in actual process will be described in detail below.

[0091] In practical applications, based on the pre-obtained focal length reduction value, a coupling pad 301 of appropriate sound velocity material and thickness is selected, and the coupling pad 301 and the pre-selected soft capsule 302 are respectively connected to the tightening assembly 2. When the soft capsule 302 is a hollow structure, ultrasonic coupling agent is filled into the cavity inside the coupling pad 301 and the soft capsule 302 through the through hole 205 or the injection tank 304, and the through hole 205 or the injection tank 304 is sealed after the ultrasonic coupling agent is injected. The through hole 205 or the injection tank 304 is tightened and assembled with the ultrasonic transducer 1 through the tightening assembly 2 to complete the focal length adjustment of the transcranial ultrasound stimulation device.

[0092] like Figures 13-16 As shown, the simulated focal sound intensity and axial sound pressure level diagrams of ultrasonic transducer 1 are compared with the measured focal sound intensity and axial normalized diagrams of the hydrophone. Figure 13 and Figure 14 The focal acoustic field intensity distribution of the piezoelectric element designed for ultrasonic transducer 1 at a specific frequency can be obtained through simulation results. The acoustic field intensity is concentrated in the 75-110mm region. The acoustic intensity distribution reveals the effect of ultrasonic transmission. The intensity is the greatest in the focal region. As the distance increases, the acoustic field intensity gradually weakens. Figure 15 and Figure 16 The intensity distribution at the focal point of the ultrasonic transducer was measured using a hydrophone. The measured diagram shows that the intensity distribution in the focal area is consistent with the simulation results. The axial sound pressure level diagrams obtained from both simulation and actual measurements show that the maximum depth of the ultrasonic treatment head's focal sound intensity is around 90mm, and it can provide a consistent sound pressure level distribution in the treatment area, thus ensuring the accuracy of the treatment.

[0093] like Figure 17As shown, schematic diagrams of four different specifications of coupling pads 301 are displayed. The upper arc-shaped protrusion 3012 of the coupling pad 301 conformally adapts to the curvature vibrating element surface of the ultrasonic transducer 1. The annular sealing block 3013 is bonded inside the tightening assembly 2, and the outer side of the annular sealing block 3013 is covered by the inner ring of the locking cover 201. These different specifications of coupling pads differ in material sound velocity and thickness. The sound velocity C of the coupling pad 301 is in the range of 900-1500m / s, corresponding to a hardness of HA0-HA20. The thickness H of the coupling pad 301 is in the range of 5-30mm.

[0094] In different assembly methods, after the ultrasound coupling component 3 comes into contact with the patient's brain 6, the soft capsule 302 is only a thin layer in contact with the skull, having little impact on ultrasound propagation; the coupling pad 301 plays a major role in ultrasound propagation; such as Figure 18 and Figure 19 As shown, the simulation of the focal length change of the designed piezoelectric element matching coupling pad 301 in water conduction is illustrated. For optimal sound conduction, the example uses silicone coupling pad 301 with a Shore hardness of HA0-HA20 and a density of approximately 1.05-1.10 g / cm³. 3 Small changes in density have little effect on sound energy attenuation. The formula for the longitudinal wave velocity of coupling pad 301 with different hardness is as follows:

[0095] ;

[0096] In the formula, C represents the speed of sound (longitudinal wave) in the coupling pad 301. K Indicates bulk modulus (the compressive strength of a material); G Indicates shear modulus (material's resistance to deformation); ρ Indicates density.

[0097] silicone K Typically, the pressure is about 1-2 GPa higher, but this is affected by the formulation. K The change is small; when selecting silicone within a certain hardness range, the value does not change significantly. The density of silicone within the HA0-HA20 range is relatively stable. ρ The variation is also limited; Shore A hardness primarily reflects the shear modulus of the material. G The higher the hardness, G The larger the value, the greater the impact on the longitudinal wave velocity. Based on the above analysis, the influence of the sound velocity C (m / s) of silicone with different hardness and the silicone thickness H (mm) on the reduction value ΔF (mm) of the ultrasonic transducer focal length was established through simulation.

[0098] like Figure 20 As shown, it is the focal length reduction value ΔF obtained by fitting. f The curve of (H,C) is plotted, and ΔF = 85.036 - 0.1752 * H - 0.0556 * C - 0.0032 * H is obtained.2 The second-order relation of +0.001*H*C has a high R² value (R 2 =0.9964), from ΔF= f The formula (H,C) can be used to adjust the focal length of the ultrasonic transducer 1 by selecting coupling pads 301 with different thicknesses and sound velocities; therefore, the ultrasonic transducer 1 can work with the ultrasonic coupling component 3 to flexibly adjust the focal length range of the treatment head to meet the needs of different treatment depths, ensuring that the ultrasound waves can be accurately focused on the target area.

[0099] This invention enables the efficient transmission of ultrasound waves to the treatment area through the tight cooperation of the tightening component 2 and the ultrasonic coupling component 3. The material selection and structural design of the ultrasonic coupling component 3 ensure the stability of the entire device after water filling, effectively preventing liquid leakage. After assembly, the ultrasonic transducer 1 and the ultrasonic coupling component 3 can maintain a stable position, avoiding loosening or displacement during treatment, and ensuring the accuracy of treatment and the stability of the equipment.

[0100] It should be noted that the coupling pad 301 and the soft capsule 302 may be made of the same or different materials.

[0101] In summary, by utilizing the above-mentioned technical solution of this utility model, the coordinated arrangement of the ultrasonic transducer 1, the tightening assembly 2, and the ultrasonic coupling assembly 3 not only achieves precise ultrasonic wave transmission but also adapts to complex head shapes. Especially at complex target points such as the bilateral ear region, the flexible nature of its soft capsule ensures a close fit with the cranial tissue, providing consistent sound wave transmission and avoiding interference from air or other substances. This significantly improves the treatment effect, enhances the device's versatility and adaptability, and enables the device to focus on treatments covering the brain, intracranial region, and superficial intracranial layers. Furthermore, it can be adapted to different treatment needs. By installing the corresponding ultrasound coupling component 3 to adjust the focal length, the multi-target treatment functionality of the ultrasound transducer 1 is enhanced. This invention, through the ultrasound coupling component 3, can adjust the focal length according to the specific conditions of different patients (such as skull thickness, treatment depth, etc.), and by changing the ultrasound focusing point, ensures that the ultrasound can accurately act on the target brain region. In addition, the ultrasound coupling component 3 also has the function of closely fitting the scalp, ensuring perfect fit even in complex target areas, reducing air gaps, reducing sound energy loss, and preventing the ultrasound beam from deviating from the normal incident line into the skull, which would lead to attenuation of transmitted energy, thereby improving the transmission efficiency of ultrasound and thus improving the treatment effect.

[0102] In this utility model, unless otherwise explicitly specified and limited, the terms "installation", "setting", "connection", "fixing", "screw connection", etc., should be interpreted broadly. For example, they can refer to a fixed connection, a detachable connection, or an integral part; they can refer to a mechanical connection or an electrical connection; they can refer to a direct connection or an indirect connection through an intermediate medium; they can refer to the internal connection of two components or the interaction between two components. Unless otherwise explicitly limited, those skilled in the art can understand the specific meaning of the above terms in this utility model according to the specific circumstances.

[0103] The above description is only a preferred embodiment of the present utility model and is not intended to limit the present utility model. Any modifications, equivalent substitutions, improvements, etc., made within the spirit and principles of the present utility model should be included within the protection scope of the present utility model.

Claims

1. A transcranial ultrasound stimulation device, characterized in that, include: Ultrasonic transducer (1); The tightening assembly (2) is located on the bottom outer side of the ultrasonic transducer (1), and the ultrasonic transducer (1) can be quickly disassembled and installed through the tightening assembly (2); An ultrasonic coupling component (3) is disposed at the bottom of the tightening component (2) and cooperates with the ultrasonic transducer (1). The ultrasonic coupling component (3) reduces the air gap during the fit to reduce sound energy loss.

2. The transcranial ultrasound stimulation device according to claim 1, characterized in that, The tightening assembly (2) includes a locking cover (201) disposed on the outer side of the bottom of the ultrasonic transducer (1), and the locking cover (201) is annular. The top inner part of the locking cover (201) is provided with several sliding grooves (202), and the sliding grooves (202) are L-shaped. The bottom inner part of the locking cover (201) is provided with a connecting platform (203) that cooperates with the ultrasonic coupling assembly (3), and the connecting platform (203) is annular.

3. A transcranial ultrasound stimulation device according to claim 2, characterized in that, The slide (202) includes a plurality of guide grooves (2021) formed at the top of the lock cover (201). A non-detachment groove (2022) is provided on one side of the bottom of the guide groove (2021) and communicates with it. An arc-shaped guide surface (2023) is provided at the connection between the top of the guide groove (2021) and the non-detachment groove (2022).

4. A transcranial ultrasound stimulation device according to claim 3, characterized in that, The bottom outer side of the ultrasonic transducer (1) is provided with several locking blocks (4) that cooperate with the slide groove (202), and the top of the locking block (4) is provided with an arc-shaped transition surface (5) that cooperates with the arc-shaped guide surface (2023).

5. A transcranial ultrasound stimulation device according to claim 2, characterized in that, The ultrasonic coupling assembly (3) includes a coupling pad (301) disposed at the bottom of the inner part of the tightening assembly (2), and a soft pouch (302) is disposed on the outer side of the coupling pad (301).

6. A transcranial ultrasound stimulation device according to claim 5, characterized in that, The coupling pad (301) includes a cylindrical coupling block (3011) disposed inside the connecting platform (203), and the top end of the cylindrical coupling block (3011) is provided with an arc-shaped protrusion (3012) that matches the bottom end of the ultrasonic transducer (1). An annular sealing block (3013) that matches the locking cover (201) is disposed on the outer side of the top end of the cylindrical coupling block (3011) and at the top end of the connecting platform (203).

7. A transcranial ultrasound stimulation device according to claim 6, characterized in that, The soft capsule (302) is a solid or hollow structure. The soft capsule (302) includes an annular connecting section (3021) located outside the connecting groove (204) located outside the bottom of the cylindrical coupling block (3011) or the bottom of the lock cover (201). The bottom end of the annular connecting section (3021) is provided with a circular fitting section (3022). The annular connecting section (3021) and the circular fitting section (3022) are connected by a deformation transition section (3023). The deformation transition section (3023) is one of an arc-shaped structure, a corrugated structure, a pleated structure, or a spiral structure.

8. A transcranial ultrasound stimulation device according to claim 7, characterized in that, When the soft capsule (302) is a hollow structure, the soft capsule (302) also includes an injection platform (303) and an injection tank (304). A plurality of the aforementioned injection platforms (303) are disposed on the outside of the soft capsule (302), and the injection groove (304) is opened on one side of the injection platform (303), and the injection groove (304) is disposed through the soft capsule (302). Ultrasonic coupling agent is filled into the cavity formed by the soft capsule (302) through the injection tank (304).

9. A transcranial ultrasound stimulation device according to claim 7, characterized in that, When the soft capsule (302) is a hollow structure, the tightening assembly (2) also includes a through hole (205). A plurality of through holes (205) are formed at the top of the lock cover (201), and the through holes (205) are configured to cooperate with the ultrasonic coupling assembly (3), and the through holes (205) are connected to the cavity inside the soft capsule (302); Ultrasonic coupling agent is filled into the cavity formed by the soft capsule (302) through the through hole (205).

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