WO2017113179A1

WO2017113179A1 - Head-mounted ultrasound stimulation device and system

Info

Publication number: WO2017113179A1
Application number: PCT/CN2015/099845
Authority: WO
Inventors: 郑海荣; 邱维宝; 苏敏; 黎国锋; 钱明; 李永川
Original assignee: 深圳先进技术研究院
Priority date: 2015-12-30
Filing date: 2015-12-30
Publication date: 2017-07-06
Also published as: CN107155309A

Abstract

A head-mounted ultrasound stimulation device (100) and system, the device (100) comprising a shell (10) for covering the head of a user, and a coupling sheath (20) provided inside the shell (10), wherein space (70) between the coupling cover (20) and the shell (10) is filled with coupling liquid, and the coupling sheath (20) contacts the head of the user when it is worn; the shell (10) is mounted with a two-dimensional area-array transducer (30), a data transceiving unit (40), a integrated circuit (50) and a power supply (60), wherein, the data transceiving unit (40) is used for receiving stimulation data from a control device (200), the stimulation data including data for controlling intensity and a focal position of a sound field generated by the two-dimensional area-array transducer (30); the integrated circuit (50) is used for converting the stimulation data into stimulation signals; the two-dimensional area-array transducer (30) is used for generating a focused ultrasonic field under stimulation by the stimulation signals to stimulate intracranial nerve cells; and the power supply (60) is used for supplying power to the data transceiving unit (40) and the integrated circuit (50). The device (100) can generate a focused sound field having a plurality of focal points, wherein, positions of the focal points and intensity of the sound field are adjustable, so as to make accurate multi-focal ultrasonic stimulation on the brain cell nucleus, thereby playing a curing effect. This device is easily operable.

Description

Head-mounted ultrasonic stimulation device and system

Technical field

The present invention relates to the field of medical device technology, and in particular, to a head-mounted ultrasonic stimulation device and system.

Background technique

With the increasing number of patients with brain diseases such as depression and Parkinson's disease, the treatment of brain diseases has gradually become the focus of modern medical research. Nowadays, in addition to oral drugs, brain treatment has also proposed many external conditions to stimulate brain cranial nucleus. The group's main therapeutic methods are light stimulation, electrical stimulation, magnetic stimulation and ultrasound stimulation. Ultrasound stimulation has received increasing attention due to its safety, non-invasiveness and effectiveness.

Techniques and tools for neural stimulation and loop regulation are important drivers of neuroscience development. The current goal of neural stimulation techniques is to modulate neuronal system function by regulating exogenous energy to a complete circuit to regulate neuronal activity. The combination of electrical, magnetic, and optical technologies and neuroscience has produced neural stimulation and regulation techniques such as deep brain electrical stimulation, magnetic stimulation, and light gene regulation.

Deep Brain Stimulation (DBS) is a target of the nucleus of the brain implanted in the electrode. It can suppress the abnormal nerve function of the target cell through controllable high-frequency current stimulation, and achieve effective intervention and treatment. The purpose of the disease. Since the DBS device has been used for tremor control, many patients have implanted DBS devices for many refractory brain diseases such as Parkinson's disease, depression, refractory epilepsy, dystonia, refractory pain, obsessive-compulsive disorder, etc. Provides an effective intervention method. However, the application of DBS also has important limitations: clinically, through craniotomy, 1 or 2 electrodes are implanted into the deep brain tissue to stimulate the nucleus, causing permanent trauma to the brain tissue and nerve circuit, and the target cannot be replaced. It is difficult to achieve stimulation of more parts of the nuclei, and the entire power supply equipment must be surgically implanted into the body. The stimulating electrode applied to the brain of the individual will affect the normal function of the body. After the DBS electrode is used for a period of time, a glial cell sheath will form around the electrode, which not only affects the efficiency of the electrode, but also affects the normal function of the body. When electrical stimulation is applied, the applied electrical stimulation always causes an excitatory response, and only when the inhibitory nuclei are stimulated can the inhibitory response be caused. These shortcomings also limit the application of electrical stimulation techniques in regulating the neural circuit.

Transcranial Magnetic Stimulation (TMS) is a non-invasive technique in which a transient, high-voltage pulse generated by a magnetic coil placed on the scalp produces a magnetic field perpendicular to the plane of the coil that acts on the brain tissue. An induced current is generated that depolarizes the nerve cells and produces an evoked potential. This technique can be used to evaluate neurophysiological pathways and is used in depression, epilepsy, stroke, schizophrenia, autism, etc. Neurological rehabilitation of the disease. However, TMS technology has bottlenecks such as insufficient depth of stimulation, inability to focus, low resolution of stimulation, and difficulty in determining the stimulus area.

Optogenetics (Optogenetics) achieves the selective regulation of a certain micro-loop at the cellular level, that is, by giving different wavelengths of laser to achieve excitatory or inhibitory regulation of a certain loop, which strongly promotes the development of neuroscience. . However, optogenetics technology activates light-sensitive channels by giving lasers of different wavelengths. Since the strong absorption of light by biological tissues severely limits the distance of light travel (only a few millimeters), it needs to be in patients or test animals. The corresponding brain region is inserted into the fiber and the fiber catheter, which inevitably damages part of the brain region during operation, resulting in the loss of certain physiological functions of the nervous system.

Methods of modulating neural activity include invasive and non-invasive techniques. However, many of these techniques, such as DBS and optogenetic techniques, require surgical implantation of stimulating electrodes, which are invasive, expensive, and even dangerous processes. For example, surgical implantation of stimulating electrodes increases secondary medical risks, such as infection. Although TMS is non-invasive, there are bottlenecks such as insufficient stimulation depth, inability to focus, low stimulation resolution, and difficulty in determining the stimulation area, which cannot be applied to deep brain stimulation.

Ultrasound, as a mechanical wave, is generated by the vibration of an object (sound source) and causes its propagation by compressing and expanding the medium. Medical ultrasound usually refers to sound waves with a frequency in the range of 20 kHz to 10 MHz. In addition to the general properties of waves, ultrasound has an important feature that it has little attenuation in human tissues such as water and muscles, and can reach deeper human tissues. The interaction between medical ultrasound and human tissue mainly uses the basic physical properties of the interaction between sound waves and matter, and has three major acoustic effects: wave effect, mechanical effect and thermal effect. These effects have important applications or great potentials in biomedicine. Traditional ultrasound has evolved into two basic functions: imaging diagnosis and thermal ablation based on wave effect and thermal effect. The wave effect can be used in ultrasound imaging diagnostic techniques such as B-ultrasound, color Doppler ultrasound, and angiography, which are widely used in clinical practice; thermal effects can be used for thermal ablation of tumors and treatment of nucleus destruction, such as High Intensity Focused Ultrasound (referred to as High Intensity Focused Ultrasound). HIFU).

The advantage of ultrasound nerve stimulation and regulation is its non-invasive nature. The latest scientific evidence for the neuromodulation of ultrasound at the molecular, cellular, animal, and human brain levels strongly demonstrates that ultrasound can penetrate the human skull non-invasively, effectively regulate synaptic plasticity, neuronal regulation, and deep brain nucleus.

At present, the ultrasound stimulation of the brain can not accurately stimulate the pathogenic nuclei of the brain. Due to the non-uniformity of the skull and the strong scattering of ultrasound, whether using a collimator or a self-focusing ultrasound Ultrasound is difficult to control through the propagation path behind the skull, so it is difficult to achieve precise positioning and can not produce precise focus in the deep brain. In response to the above problems, no effective solution has been proposed yet.

Summary of the invention

The present invention provides a head-mounted ultrasonic stimulation device and system to at least solve the problem that the existing ultrasound-stimulated brain solution cannot accurately stimulate the brain-causing nuclei.

According to an aspect of the present invention, a head-mounted ultrasonic stimulation device includes: a housing, a coupling sleeve, a two-dimensional array transducer, a data transceiving unit, an integrated circuit, and a power source; a coupling portion of the user's head is disposed inside the casing, and a space formed by the coupling sleeve and the casing is filled with a coupling liquid, and when the user wears the head-mounted ultrasonic stimulation device, the coupling a set of contact with a user's head; the two-dimensional array transducer, the data transceiving unit, the integrated circuit and the battery are mounted on the housing; the data transceiving unit is configured to receive from Controlling stimulation data of the device and transmitting the stimulation data to the integrated circuit, wherein the stimulation data includes data that controls an intensity and a focus position of a focused ultrasound sound field generated by the two-dimensional array transducer; An integrated circuit coupled to the data transceiving unit for converting the stimulation data into an excitation signal and transmitting the excitation signal to the two-dimensional array transducer; the two-dimensional area array transducer, connection The integrated circuit is configured to receive the excitation signal, and generate a focused ultrasound sound field under excitation of the excitation signal to ultrasonically stimulate a user's intracranial nerve cells; the power source is connected to the data transceiver unit and the An integrated circuit for supplying power to the data transceiver unit and the integrated circuit.

According to another aspect of the present invention, a head-mounted ultrasonic stimulation system is provided, comprising: a head-mounted ultrasonic stimulation device and a control device; the head-mounted ultrasonic stimulation device being a head-mounted ultrasonic stimulation of any of the above a control device connected to the data transceiving unit in the head-mounted ultrasonic stimulation device for transmitting stimulation data to the data transceiving unit, wherein the stimulation data comprises controlling two-dimensional area array transducer generation Focus on the intensity and focus position of the ultrasound sound field.

With the head-mounted ultrasonic stimulation device and system of the present invention, the device is worn on the head of the patient, and the integrated circuit converts the stimulation data sent by the control device into an excitation signal, and the excitation signal is used to perform the two-dimensional array transducer Excitation, the focus sound field that forms multiple focal points, the position of the focus and the intensity of the sound field can be adjusted, so that the multi-focus precision ultrasound stimulation of the patient's brain diseased cell nuclei can be effective for patients with various brain diseases. The treatment effect is simple and easy to use.

DRAWINGS

The drawings are intended to provide a further understanding of the invention, and are intended to be a part of the invention. In the drawing:

1 is a schematic structural view of a head-mounted ultrasonic stimulation device according to an embodiment of the present invention;

Figure 2 is a cross-sectional view of a head-mounted ultrasonic stimulation device in accordance with an embodiment of the present invention;

3 is a schematic structural view of a two-dimensional area array transducer according to an embodiment of the present invention;

4 is a schematic structural view of a head-mounted ultrasonic stimulation system according to an embodiment of the present invention;

Figure 5 is a schematic illustration of ultrasonic stimulation of an embodiment of the present invention.

detailed description

The technical solutions in the embodiments of the present invention are clearly and completely described in the following with reference to the drawings in the embodiments of the present invention. It is obvious that the described embodiments are only a part of the embodiments of the present invention, and not all of the embodiments. All other embodiments obtained by a person of ordinary skill in the art based on the embodiments of the present invention without creative efforts are within the scope of the present invention.

Embodiments of the present invention provide a head-mounted ultrasonic stimulation device suitable for precise acoustic stimulation of a brain-causing nuclei of a brain disease patient. 1 is a schematic structural view of a head-mounted ultrasonic stimulation device according to an embodiment of the present invention, and FIG. 2 is a cross-sectional view of a head-mounted ultrasonic stimulation device according to an embodiment of the present invention, as shown in FIGS. 1 and 2, the head-mounted ultrasonic stimulation The device includes a housing 10, a coupling sleeve 20, a two-dimensional array transducer 30, a data transceiving unit 40, an integrated circuit 50, and a power source 60. The structure will be specifically described below.

The housing 10 can be sleeved on the user's head, the coupling sleeve 20 is disposed inside the housing 10, and the space 70 formed by the coupling sleeve 20 and the housing 10 is filled with the coupling liquid. When the user wears the head-mounted ultrasonic stimulation device, the coupling sleeve 20 is in contact with the user's head, similar to wearing a hat. The shape of the casing may be a semi-spherical shape as shown in FIG. 1 and FIG. 2, or may be other shapes, such as a square casing, and the inner coupling sleeve is a hemispherical shape conforming to the shape of the user's head, and the coupling sleeve and the head are worn when worn. Close contact. The material of the coupling sleeve 20 is an elastic material having the same or similar acoustic impedance as the human tissue, and the acoustic impedance of the coupling liquid is the same as the acoustic impedance of the human tissue, so that the sound wave is emitted from the two-dimensional array transducer 30 to the head of the human body. The attenuation in the process is as small as possible.

The two-dimensional area array transducer 30, the data transceiving unit 40, the integrated circuit 50, and the battery 60 are all mounted on the housing 10. The mounting positions of the two-dimensional array transducer 30, the data transceiving unit 40, the integrated circuit 50, and the battery 60 may be at the top end of the housing 10 as shown in FIGS. 1 and 2, or may be at ambient or other locations. As shown in FIG. 1 , an openable and closable cover A can be disposed at the installation position to prevent dust, moisture, and the like from accumulating in the environment, the data transceiving unit 40, the integrated circuit, and the integrated circuit. 50 and battery 60, affecting its function.

The data transceiving unit 40 is configured to receive the stimulation data from the control device and transmit the stimulation data to the integrated circuit 50. The stimulation data emitted by the control device may include data for controlling the intensity and focus position of the focused ultrasound sound field generated by the two-dimensional area array transducer 30. The stimulation data can be given in conjunction with the location of the nucleus of the patient's brain-causing cells.

The integrated circuit 50 is coupled to the data transceiving unit 40 for converting the stimulation data into an excitation signal (electrical signal) and transmitting the excitation signal to the two-dimensional array transducer 30. The integrated circuit 50 is specifically configured to control the time delay of the excitation of the electrical signals to the array elements, so that the sound waves generated by the array elements are combined into a sound field having a plurality of focal points, that is, the position of the focus can be moved by the time delay of the excitation signal, The head is subjected to multi-point stimulation to achieve electronic focusing. The specific structure of the integrated circuit 400 can be set according to the actual structure and needs of the head-mounted ultrasonic stimulation device as long as the time delay for converting the stimulation data into the excitation signal and controlling the excitation signal can be achieved. When the integrated circuit 50 controls the voltage of the electrical signal to have different magnitudes, the intensity of the sound waves generated by the array elements is different, and thus the intensity of the sound field and its focus generated by the two-dimensional array transducer 30 can be adjusted.

The two-dimensional area array transducer 30 is coupled to the integrated circuit 50 for receiving an excitation signal and generating a focused ultrasonic sound field under excitation of the excitation signal to ultrasonically stimulate the user's intracranial nerve cells.

A power supply 60, coupled to the data transceiving unit 40 and the integrated circuit 50, is used to power the data transceiving unit 40 and the integrated circuit 50. The power source 60 can be a battery or other power supply device.

The device is worn on the head of the patient by the above-mentioned head-mounted ultrasonic stimulation device, and the integrated circuit converts the stimulation data sent by the control device into an excitation signal, and the excitation signal is used to excite the two-dimensional array transducer to form a plurality of The focused sound field of the focus, the position of the focus and the intensity of the sound field can be adjusted, so that the multi-focus precision ultrasound stimulation of the patient's brain diseased cell nuclei can effectively treat the patients with various brain diseases. Simple and easy to use.

The existing two-dimensional array probe is structurally focused, and an acoustic lens is added to the probe. Through such a structure, the path of the sound wave is changed, and the sound waves are gathered together to achieve focusing. The two-dimensional area array transducer of the present invention is a phased array probe, which is an electronic focus, that is, an electronic system (such as a control device, a data transceiving unit, and an integrated circuit) is used to control a focused sound field that realizes multiple focal points.

3 is a schematic structural view of a two-dimensional area array transducer according to an embodiment of the present invention. As shown in FIG. 3, the two-dimensional area array transducer 30 may include a backing 31 and a piezoelectric layer bonded in order from bottom to top. 32 and matching layer 33. Wherein, when the user wears the head-mounted ultrasonic stimulation device, the distance between the matching layer 33 and the user's head is smaller than the distance between the backing 31 and the user's head, that is, the matching layer 33 is closer to the user's head.

A plurality of equally spaced circuit boards 34 (e.g., flexible circuit boards) are embedded in the backing 31. The circuit board 34 is exposed from the bottom surface of the backing 31 by a predetermined length, and the top surface of the backing 31 is plated with electrodes. The circuit board 34 has leads 35 on which the leads 35 can be connected via an electrical cable 50, as shown in FIG.

The piezoelectric layer 32 is divided into a plurality of array elements, and the gap between the array elements is filled with a decoupling material. The upper surface and the lower surface of the piezoelectric layer 32 are plated with electrodes to form a first electrode surface and a second electrode surface, and the second electrode surface and the electrode surface of the backing 31 After being aligned, bonding is performed by a conductive material (for example, conductive epoxy, conductive rubber, etc.), so that the array element is electrically connected to the lead 35 on the circuit board 34 (ie, the lead element is taken out by the lead wire); the first electrode surface and the matching layer 33 Bonding using an organic bonding material (for example, epoxy resin, silicone rubber, etc.). The thickness and acoustic impedance of the matching layer are formulated according to acoustic parameters such as acoustic impedance, sound speed, and operating frequency of the piezoelectric material, and can be realized by those skilled in the art in combination with the prior art, and will not be described in detail herein.

The piezoelectric layer 32 may be a piezoelectric ceramic, a piezoelectric composite material, a single crystal material, or the like.

To highlight the stimulating effect, the backing 31 may use a material having a lower acoustic impedance than a predetermined threshold (low acoustic impedance), for example, a microbubble may be filled in the epoxy resin to form a backing.

In one embodiment, in view of a better stimulating effect, the two-dimensional array transducer 30 can be formed in a curved configuration with the arc curved upwardly and the center of the arcuate surface above the matching layer 33. The arc of the arc is the same as the arc of the corresponding human skull, so that the sound wave is incident perpendicularly from the skull, reducing the reflection of the sound wave during the propagation process. As shown in Fig. 1, the two-dimensional area array transducer 30 is mounted on the top end of the device, and its curvature is in line with the curvature of the tip of the user's head, so that head stimulation can be better achieved. Specifically, after the two-dimensional array transducer 30 is processed, the two-dimensional array transducer 30 can be bent into a curved surface as needed in an incubator (temperature can be 60 ° C to 120 ° C). Preferably, the ultrasonic frequency of the two-dimensional array transducer 30 can be from 0.2 MHz to 5 MHz, and the number of elements is from 1 to 4096.

A schematic structure of the housing 10 will be described by taking a hemispherical housing as an example. As shown in FIG. 1, the housing 10 includes: a resilient cap 11 in which a support member 12 is disposed. The support member 12 is used to maintain the shape of the housing 10 and support the housing 10 for mounting a two-dimensional array. The energy processor 30, the data transceiver unit 40, the integrated circuit 50 and the battery 60. The elastic cap 11 can be understood as a hollow hat-like structure, and the hollow portion is provided with a support to maintain the shape of the casing.

The material of the elastic cap 11 may be rubber or other elastic material, and has high shrinkage performance, and can be applied to heads of different sizes, and the material shrinkage can be freely adjusted according to the size of the head. The support 12 can be a metallic material such as a metal strip that can change shape.

The sides of the coupling sleeve 20 are bonded to the elastic cap 11. The material of the coupling sleeve 20 may be an elastic material (such as rubber) that is the same as or similar to the acoustic impedance of the human tissue, and is easily deformed, and the shape is changed to accommodate various sizes of the head, and the head may be wrapped according to different head shapes.

In a preferred embodiment, the data transceiving unit 40 can transmit data wirelessly. The wireless transmission method eliminates the connection between the head-mounted ultrasonic stimulation device and the control device, simplifying the structure.

The embodiment of the present invention further provides a head-mounted ultrasonic stimulation system, and FIG. 4 is a schematic structural diagram of a head-mounted ultrasonic stimulation system according to an embodiment of the present invention. As shown in FIG. 4, the system includes: a head-mounted ultrasonic stimulation device. 100 and control device 200.

The head-mounted ultrasonic stimulation device 100 is the head-mounted ultrasonic stimulation device described in the above embodiments, and details are not described herein again.

The control device 200 is coupled to the data transceiving unit 40 in the head-mounted ultrasonic stimulation device 100 for transmitting stimulation data to the data transceiving unit 40, wherein the stimulation data includes controlling the focused ultrasound sound field generated by the two-dimensional area array transducer 30. Data on intensity and focus position.

The head-mounted ultrasonic stimulation device is worn on the patient's head by the above-mentioned head-mounted ultrasonic stimulation system, and the integrated circuit converts the stimulation data sent by the control device into an excitation signal, and the excitation signal is used to perform the two-dimensional area array transducer Excitation, the focus sound field that forms multiple focal points, the position of the focus and the intensity of the sound field can be adjusted, so that the multi-focus precision ultrasound stimulation of the patient's brain diseased cell nuclei can be effective for patients with various brain diseases. The treatment effect is simple and easy to use.

The control device 200 is specifically configured to control the time delay of the excitation signals of the array elements of the two-dimensional area array transducer 30 by the integrated circuit 50 in the head-mounted ultrasonic stimulation device 100 to control the number and position of the focus. 5 is a schematic diagram of ultrasonic stimulation according to an embodiment of the present invention. As shown in FIG. 5, the excitation signal transmitted by the integrated circuit 50 to the two-dimensional array transducer 30 includes excitation signals 1 to N corresponding to N array elements, respectively. The excitation signal is transmitted through the excitation channel to the corresponding array element, wherein the excitation channel is formed by the cable line 36, the lead 35, and the circuit board 34. When the time of each excitation signal reaching the corresponding array element is different, the time for generating the sound waves by each array element is controlled differently, that is, the number and position of the focus are controlled.

Preferably, data transmission between the data transceiving unit 40 and the control device 200 can be performed wirelessly to simplify the structure.

In summary, the present invention provides a head-mounted ultrasonic stimulation device and system that uses an electronic system to control a position of a two-dimensional array transducer capable of moving a focus, positioning a focus position on a diseased nuclei, and causing a diseased nuclei Perform precise stimulation and adjust the intensity of the stimulus; at the same time, focus the sound field of multiple focal points and stimulate the lesion nuclei. In addition, the housing and the coupling sleeve can be adapted to various head types and are convenient to use.

It should be understood that portions of the invention may be implemented in hardware, software, firmware or a combination thereof. In the above-described embodiments, multiple steps or methods may be implemented in software or firmware stored in a memory and executed by a suitable instruction execution system. For example, if implemented in hardware, as in another embodiment, it can be implemented by any one or combination of the following techniques well known in the art: having logic gates for implementing logic functions on data signals. Discrete logic circuits, application specific integrated circuits with suitable combinational logic gates, programmable gate arrays (PGAs), field programmable gate arrays (FPGAs), etc.

In the description of the present specification, the description with reference to the terms "one embodiment", "some embodiments", "example", "specific example", or "some examples" and the like means a specific feature described in connection with the embodiment or example. A structure, material or feature is included in at least one embodiment or example of the invention. In the present specification, the schematic representation of the above terms does not necessarily mean the same embodiment or example. Furthermore, the particular features, structures, materials, or characteristics described may be combined in a suitable manner in any one or more embodiments or examples.

The above described specific embodiments of the present invention are further described in detail, and are intended to be illustrative of the embodiments of the present invention. All modifications, equivalent substitutions, improvements, etc., made within the spirit and scope of the invention are intended to be included within the scope of the invention.

Claims

A head-mounted ultrasonic stimulation device, comprising: a housing, a coupling sleeve, a two-dimensional array transducer, a data transceiver unit, an integrated circuit, and a power source;

The housing may be sleeved on the user's head, the coupling sleeve is disposed inside the housing, and the space formed by the coupling sleeve and the housing is filled with a coupling liquid when the user wears the head-mounted ultrasound When the device is stimulated, the coupling sleeve is in contact with the user's head;

The two-dimensional area array transducer, the data transceiver unit, the integrated circuit, and the battery are all mounted on the housing;

The data transceiving unit is configured to receive stimulation data from the control device and transmit the stimulation data to the integrated circuit, wherein the stimulation data comprises controlling a focused ultrasound sound field generated by the two-dimensional area array transducer Data of intensity and focus position;

The integrated circuit is coupled to the data transceiver unit for converting the stimulation data into an excitation signal and transmitting the excitation signal to the two-dimensional array transducer;

The two-dimensional area array transducer is coupled to the integrated circuit for receiving the excitation signal, and generating a focused ultrasonic sound field under excitation of the excitation signal to perform ultrasonic stimulation on a user's intracranial nerve cells;

The power source is connected to the data transceiver unit and the integrated circuit for supplying power to the data transceiver unit and the integrated circuit.
The head-mounted ultrasonic stimulation device according to claim 1, wherein the two-dimensional array transducer comprises: a backing, a piezoelectric layer and a matching layer bonded in order from bottom to top;

The distance between the matching layer and the user's head is less than the distance between the backing and the user's head;

The backing is embedded with a plurality of circuit boards, the circuit board is exposed from a bottom surface of the backing by a predetermined length, and a top surface of the backing is plated with electrodes;

The piezoelectric layer is divided into a plurality of array elements, and a gap between the array elements is filled with a decoupling material;

The upper surface and the lower surface of the piezoelectric layer are plated with electrodes to form a first electrode surface and a second electrode surface, and the second electrode surface is aligned with the electrode surface of the backing and then bonded by a conductive material. The array element is electrically connected to a lead on the circuit board; the first electrode surface is bonded to the matching layer.
The head-mounted ultrasonic stimulation device according to claim 2, wherein the lead wires on the circuit board are connected to the integrated circuit through a cable.
The head-mounted ultrasonic stimulation device of claim 2, wherein the backing uses a material having an acoustic impedance that is less than a predetermined threshold.
The head-mounted ultrasonic stimulation device according to claim 2, wherein the two-dimensional area array transducer is a curved surface structure, the arc is curved upward, and a center of the curved surface is located above the matching layer. The curvature of the curved surface is the same as the curvature of the corresponding human skull.
The head-mounted ultrasonic stimulation device according to claim 1, wherein the housing comprises: an elastic cap, and a support member is provided in the elastic cap, the support member for maintaining a shape of the housing And supporting the housing to mount the two-dimensional array transducer, the data transceiver unit, the integrated circuit, and the battery;

The edge of the coupling sleeve is bonded to the elastic cap, and the material of the coupling sleeve is the same elastic material as that of the human body tissue, and the acoustic impedance of the coupling fluid is the same as the acoustic impedance of the human tissue.
The head-mounted ultrasonic stimulation device according to claim 1, wherein the data transceiving unit performs data transmission by wireless.
A head-mounted ultrasonic stimulation system, comprising: a head-mounted ultrasonic stimulation device and a control device;

The head-mounted ultrasonic stimulation device is the head-mounted ultrasonic stimulation device according to any one of claims 1 to 7;

The control device is connected to a data transceiving unit in the head-mounted ultrasonic stimulation device for transmitting stimulation data to the data transceiving unit, wherein the stimulation data comprises controlling a focus generated by a two-dimensional area array transducer Ultrasonic sound field intensity and focus position data.
The head-mounted ultrasonic stimulation system according to claim 8, wherein the control device is specifically configured to control each of the two-dimensional area array transducers by an integrated circuit in the head-mounted ultrasonic stimulation device The time delay of the excitation signal of the array element to control the number and position of the focus.
The head-mounted ultrasonic stimulation system according to claim 8, wherein the data transceiving unit and the control device perform data transmission by wireless.