Transducer, wearable ultrasound device, and ultrasound monitoring treatment system

Abstract

A transducer, a wearable ultrasound device, and an ultrasound monitoring treatment system. The transducer comprises at least one treatment component, at least one monitoring component and an ultrasound isolation layer. The treatment component and the monitoring component are suitable for being connected to a control circuit in the wearable ultrasound device, and the monitoring component feeds back to the control circuit in real time the treatment state information of a region to be treated monitored by the monitoring component, such that the control circuit adjusts the orientation and power of an ultrasound wave emitted by the treatment component. In addition, according to the real-time feedback from monitoring, imaging or detection components, the ultrasound monitoring treatment system can adjust the relative spatial position of the transducer in a treatment unit by means of a mechanical structure, or can adjust the amplitude and phase deviation of an excitation signal so as to change the angle, the treatment depth and the radiation intensity of an ultrasound radiation field. Therefore, by means of the feedback by AI algorithm, the present application can achieve self-adaptive adjustment on different targeting treatment depths and orientations, thereby achieving the purposes of real-time monitoring and controllable treatment.

Description

A transducer, a wearable ultrasound device, and an ultrasound monitoring and treatment system

[0001] CROSS-REFERENCE TO RELATED APPLICATIONS

[0002] This application claims priority to the Chinese patent application filed with the China Patent Office on December 14, 2023, with application number 202311723547.X, and invention name “A transducer, a wearable ultrasound device, and an ultrasound monitoring and treatment system”, the entire contents of which are incorporated by reference into this application. Technical Field

[0003] The present application relates to the technical field of medical devices, and in particular to a transducer, a wearable ultrasound device, and an ultrasound monitoring and treatment system. Background Art

[0004] Tissue disorders such as thrombosis, varicose veins, uterine fibroids, and prostate disease have a high clinical incidence. Uterine fibroids have an incidence of approximately 30%, and tumors and thrombosis are associated with high mortality and disability rates. For example, deep vein thrombosis (DVT) is one of the most common peripheral vascular diseases, with an incidence of approximately 2‰. In the acute phase of DVT, thrombus multiplication can lead to progressive venous obstruction, even causing cerulea cerulea, limb necrosis, and the need for amputation. Dislodged free thrombi can also cause fatal pulmonary embolism.

[0005] Currently, commonly used treatments for tissue lesions in clinical practice include drug therapy, surgical treatment, radiotherapy, and interventional therapy. Drug therapy is a conservative treatment method, generally used for early mild tissue lesions and postoperative recurrence suppression, and the side effects of drugs are relatively large. For severe tissue lesions, such as tumors, surgical treatment and radiotherapy are usually used. Among them, surgical treatment is a traumatic treatment method that can easily damage surrounding tissues, and the risks of surgery and postoperative complications are high. Radiotherapy has a great risk of ionizing radiation for both doctors and patients, and it is difficult to kill all diseased tissues. It also has high side effects such as skin damage complications and nausea and vomiting. High-intensity focused ultrasound therapy is a safe, effective, and non-invasive treatment method without ionizing radiation. The thermal and cavitation effects generated by the high-intensity energy concentration at the focus can effectively destroy and ablate diseased tissues to achieve the purpose of treatment. However, due to the high energy, it is easy to burn the skin and damage the surrounding normal blood vessels and tissues during the propagation path. At the same time, in order to achieve the purpose of precise treatment, ablation treatment needs to be performed in real time under the guidance of imaging methods such as CT / MRI. In addition, the external high-intensity focused probe is large in size, and the doctor needs to adjust the probe position, irradiation direction and irradiation intensity in real time according to the imaging monitoring results, which greatly increases the difficulty of the operation and the risk of ionizing radiation. Summary of the Invention

[0006] Therefore, the purpose of this application is to avoid the shortcomings of the prior art and provide a wearable intelligent ultrasound real-time monitoring and treatment device.

[0007] To this end, the present application provides a transducer suitable for connecting to an external control circuit, comprising:

[0008] at least one treatment element, comprising a treatment working layer, wherein the treatment working layer is adapted to emit ultrasound waves to the area to be treated to assist in ablation treatment;

[0009] At least one monitoring member, comprising a monitoring working layer, wherein the monitoring working layer is adapted to transmit ultrasonic waves to the area to be treated so as to locate the treatment area in real time and monitor the treatment status of the area to be treated;

[0010] an ultrasonic isolation layer, provided between the monitoring element and the treatment element;

[0011] The treatment element and the monitoring element are suitable for connection to an external control circuit, and the monitoring element feeds back the treatment status information of the monitored area to be treated to the external control circuit in real time, so that the external control circuit adjusts the direction and power of the ultrasonic wave emitted by the treatment element.

[0012] Optionally, the treatment component and the monitoring component are placed side by side.

[0013] Optionally, a placement cavity is provided inside the treatment component, the monitoring component is provided in the placement cavity, and the ultrasound isolation layer is provided between the wall of the placement cavity and the monitoring component.

[0014] Optionally, the ultrasonic isolation layer is a PVC cavity or acrylic cavity or epoxy resin mixed hollow glass microspheres or high sound attenuation coefficient insulating material filled between the monitoring component and the placement cavity wall, and the PVC cavity or acrylic cavity is filled with gas or vacuum.

[0015] Optionally, the thickness of the ultrasonic isolation layer is N+1 / 2 wavelength of the therapeutic ultrasound wave, where N is a positive integer.

[0016] Optionally, the treatment working layer and the monitoring working layer work simultaneously, or the monitoring working layer monitors the treatment status of the area to be treated during the working intervals of the treatment working layer and feeds back the status to the external control circuit.

[0017] Optionally, a backing layer is further included, and the treatment component and the monitoring component are designed as an integrated structure, sharing a backing layer, and the impedance of the backing layer material matches that of the treatment component.

[0018] Optionally, the treatment member further comprises a treatment matching layer, which is provided on a side of the treatment working layer away from the backing layer;

[0019] The monitoring component further includes a monitoring matching layer, which is arranged on a side of the monitoring working layer away from the backing layer, and the treatment matching layer is arranged on the same side as the monitoring matching layer.

[0020] A wearable ultrasound device includes at least one treatment unit, wherein the treatment unit includes a flexible PCB circuit board and / or a metal plate and at least one transducer as described above, and the transducer is connected to the flexible PCB circuit board or metal plate.

[0021] Optionally, several of the transducers are divided into several groups and arranged on the surface of the flexible PCB circuit board, and several of the transducers in any group are connected in series and then connected to the external control circuit to achieve single frequency, multi-frequency or mixed frequency treatment.

[0022] Optionally, the treatment unit further includes a modified flexible skin-friendly package, the transducer is disposed between the metal plate and the modified flexible skin-friendly package, and the transducer is electrically connected to both the metal plate and the modified flexible skin-friendly package.

[0023] Optionally, the treatment unit further includes an insulating protective layer disposed between the metal plate and the modified flexible skin-friendly package, and the peripheral side of the transducer is disposed within the insulating protective layer.

[0024] Optionally, the treatment unit further includes a modified flexible skin-friendly package, the transducer is provided between the flexible PCB circuit board and the modified flexible skin-friendly package, and the transducer is electrically connected to the flexible PCB circuit board and the modified flexible skin-friendly package;

[0025] The metal plate is arranged on a side of the flexible PCB circuit board away from the transducer, and the metal plate is insulated from the flexible PCB circuit and the transducer.

[0026] Optionally, the treatment unit further includes a support member, and the support member is disposed inside the modified flexible skin-friendly package.

[0027] Optionally, the flexible PCB circuit board includes a transducer pad, the transducer pad includes positive and negative poles, the transducer is arranged on the transducer pad, and the positive and negative poles of the transducer pad are respectively suitable for being electrically connected to the positive and negative poles on the transducer.

[0028] Optionally, the treatment unit further includes a temperature measuring component connected to the flexible PCB circuit board and arranged on the same side as the transducer.

[0029] Optionally, the treatment unit further includes a front packaging protection layer and a rear packaging protection layer, and the front packaging protection layer and the rear packaging protection layer are arranged on both sides of the flexible PCB circuit board.

[0030] Optionally, the transducer on the surface of the flexible PCB circuit board is arranged toward the front packaging protection layer, and the treatment unit further includes a waterproof isolation layer, which is arranged between the rear packaging protection layer and the flexible PCB circuit board.

[0031] Optionally, a transducer spatial sound field radiation direction changing device is provided in the treatment unit to change the spatial sound field radiation direction of each transducer in the treatment unit.

[0032] Optionally, the transducer spatial acoustic field radiation direction-changing device is an elastic member, the elastic member having an elastic force that causes the front encapsulation protective layer to bend in an arc shape, so that the front encapsulation protective layer conforms to the targeted skin area to be treated. Optionally, a tensioning member is further included, the tensioning member being connected to the elastic member and configured to shorten under the action of an external force to pull the elastic member, thereby reducing the bending angle of the front encapsulation protective layer.

[0033] Optionally, a heat dissipation structure is provided in the treatment unit, and the heat dissipation structure is suitable for contacting an external cold source, or the heat dissipation structure is suitable for passing a cooling medium.

[0034] An ultrasonic real-time monitoring and treatment system comprises the wearable ultrasonic device described above, and a control and display component, an intelligent monitoring component, an ultrasonic driving component, and a protection component electrically connected to the wearable ultrasonic device.

[0035] The transducer, wearable ultrasound device, and ultrasound monitoring and treatment system provided in this application have the following advantages:

[0036] 1. The present application provides a transducer suitable for connection to an external control circuit, comprising at least one therapeutic element, at least one monitoring element and an ultrasonic isolation layer, wherein the therapeutic element comprises a therapeutic working layer, which is suitable for emitting ultrasonic waves to the area to be treated to assist in ablation treatment; the monitoring element comprises a monitoring working layer, which is suitable for emitting ultrasonic waves to the area to be treated to locate the treatment area and monitor the treatment status of the area to be treated in real time; the ultrasonic isolation layer is arranged between the monitoring element and the therapeutic element; wherein the therapeutic element and the monitoring element are suitable for connection to an external control circuit, and the monitoring element feeds back the treatment status information of the area to be treated that it monitors to the external control circuit in real time, so that the external control circuit adjusts the direction and power of the ultrasonic waves emitted by the therapeutic element.

[0037] The transducer of this structure, the treatment component and the monitoring component are suitable for connection with an external control circuit, the treatment component is used to transmit ultrasonic waves to the area to be treated, and use the cavitation effect and mechanical effect of ultrasonic waves to perform ablation treatment on the area to be treated; the monitoring component is used to locate the treatment area in real time during the treatment process and monitor the elastic mechanical changes, Doppler blood flow changes, vascular recanalization information, etc. of the target tissue in the area to be treated, and provide real-time feedback to the external control circuit to determine whether the target area has reached the required treatment dose during the treatment process and whether coagulative necrosis of the target tissue has been caused. The control circuit controls the treatment component to adjust the optimal ultrasonic treatment parameters according to the preset treatment plan information; an ultrasonic isolation layer is set between the treatment component and the monitoring component to prevent the ultrasonic waves generated by the treatment component and the monitoring component from affecting each other during operation, causing the transducer to fail to work normally.

[0038] 2. This application provides a transducer in which a treatment element and a monitoring element are placed side by side, and a backing layer is provided on the bottom sides of the treatment element and the monitoring element. The backing layer and the matching layer are arranged on opposite sides of the working layer. During treatment, the backing layer absorbs the acoustic energy back-radiated by the transducer, reducing interference of the back-radiated signal on the external control circuit and improving the quality of the transmitted pulse. By placing the treatment element and the monitoring element side by side and sharing a backing layer, the shared backing layer can effectively reduce the overall design size of the transducer.

[0039] 3. The present application provides a wearable ultrasound device in which three transducers are connected in series as a group, which can increase the longitudinal ultrasound treatment length, and three groups of transducers are arranged and packaged longitudinally at intervals to form a treatment unit, thereby increasing the transverse ultrasound treatment width.

[0040] 4. The present application provides a wearable ultrasound device, in which the treatment unit further includes three temperature measuring elements, which are evenly arranged on the sides of the three groups of treatment units to monitor the temperature rise status of the transducer in real time. The temperature measuring elements are thermistors, etc., and the temperature measuring elements are connected to the external control circuit through signal transmission lines to transmit the temperature information of the temperature measuring elements to the external control circuit.

[0041] 5. The present application provides a wearable ultrasound device that is fixed to a human limb via Velcro. Three groups of treatment units are distributed around the limb. The ultrasound waves emitted from the transducers inside the treatment units form an ultrasound irradiation area a that can completely cover the targeted lesions. The arc-shaped structure of the treatment units converges the ultrasound beams to cover the targeted lesions, and the beams of multiple groups of treatment units achieve all-round coverage and monitoring of the lesion sites. The monitoring components in the transducers inside the treatment units monitor the status information of the targeted lesions and provide real-time feedback to the external control circuit. The external control circuit makes decisions on the treatment plan of the treatment unit, which can provide single-frequency treatment, multi-frequency treatment, or mixed-frequency treatment plans. The optimal sound wave irradiation direction and intensity plan is given according to the current treatment status.

[0042] 6. The present application provides a wearable ultrasound device, in which the treatment unit adopts a curved structure design, which can better fit the targeted skin of the wearing part.

[0043] 7. The present application provides a wearable ultrasound device, wherein the treatment unit further includes a modified flexible skin-friendly package, the transducer is arranged between the metal plate and the modified flexible skin-friendly package, and the transducer is electrically connected to the metal plate and the modified flexible skin-friendly package.

[0044] The transducer of this structure has a metal plate as its bottom layer, and the material is a metal material with good ductility, such as copper, gold, etc. One side electrode of the transducer is directly connected to the metal plate. On the one hand, the metal plate can provide a reliable connection and stable electrical performance for the transducer, and it can also improve the stability of the transducer waveform and allow high-power current to pass through. On the other hand, the metal plate is made of a metal material with high thermal conductivity and ductility, such as copper or gold, and because there is a large area of ​​contact between the metal plate and the transducer, efficient heat dissipation can be achieved.

[0045] 8. The present application provides a wearable ultrasound device, wherein the flexible PCB circuit board includes a transducer pad, the transducer pad includes positive and negative poles, the transducer is arranged on the transducer pad, and the positive and negative poles of the transducer pad are respectively suitable for electrical connection with the positive and negative poles on the transducer.

[0046] In this transducer structure, the flexible PCB circuit board is covered with insulating oil except for the transducer pads, achieving complete electrical isolation between the transducers. The transducer pads contain positive and negative electrodes. The transducer's emitting surface, which is plated with an insulating layer, can be extended with a metal coating such as silver to achieve electrical connection between the transducer's emitting surface and the positive pad. At the same time, the negative pad is directly connected to the transducer's negative electrode, thereby locating the transducer's positive electrode on the same surface. In combination with a circuit board with transducer pads, the need for soldering wires on the transducer's emitting surface can be avoided, effectively improving transducer performance.

[0047] 9. The present application provides a wearable ultrasound device, wherein an elastic member is inserted into the treatment unit, and the elastic member has an elastic force that drives the front packaging protective layer to bend in an arc shape so that the front packaging protective layer conforms to the targeted skin area to be treated. The device also includes a tensioning member connected to the elastic member, and the tensioning member is configured to shorten under the action of an external force to pull the elastic member to reduce the bending angle of the front packaging protective layer. BRIEF DESCRIPTION OF THE DRAWINGS

[0048] In order to more clearly illustrate the specific implementation methods of the present application or the technical solutions in the prior art, the following is a brief introduction to the drawings required for use in the specific implementation methods or the description of the prior art. Obviously, the drawings described below are some implementation methods of the present application. For ordinary technicians in this field, other drawings can be obtained based on these drawings without any creative work.

[0049] FIG1 is a schematic structural view of a transducer provided in an embodiment of the present application;

[0050] FIG2 is another schematic structural view of a transducer provided in an embodiment of the present application;

[0051] FIG3 is a schematic structural diagram of a treatment unit in a wearable ultrasound device provided in an embodiment of the present application;

[0052] FIG4 is a perspective view of a treatment unit in a wearable ultrasound device provided in an embodiment of the present application;

[0053] FIG5 is a structural diagram of a wearable ultrasound device provided in an embodiment of the present application;

[0054] FIG6 is a structural diagram of a wearable ultrasound device provided in an embodiment of the present application in a bent state;

[0055] FIG7 is a schematic diagram of the overall structure of a wearable ultrasound device provided in an embodiment of the present application;

[0056] FIG8 is a schematic diagram of an ultrasound device provided in an embodiment of the present application;

[0057] FIG9 is another schematic structural diagram of a treatment unit in a wearable ultrasound device provided in an embodiment of the present application;

[0058] FIG10 is a schematic diagram of another structure of a treatment unit in a wearable ultrasound device provided in an embodiment of the present application;

[0059] FIG11 is another schematic structural diagram of a flexible PCB circuit board in a wearable ultrasound device provided in an embodiment of the present application;

[0060] FIG12 is a diagram illustrating a working state of an elastic member in a wearable ultrasound device provided in an embodiment of the present application;

[0061] FIG13 is a schematic structural diagram of a wearable ultrasound device provided in an embodiment of the present application when the treatment unit is in a flat state;

[0062] FIG14 is a schematic diagram showing the distribution of cooling elements in a wearable ultrasound device provided in an embodiment of the present application;

[0063] FIG15 is a schematic diagram of an ultrasound monitoring treatment system provided in an embodiment of the present application;

[0064] FIG16 is a diagram illustrating the time-alternating distribution of electrical signals of different center frequencies in a mixed-frequency excitation modulation signal that can be emitted by an ultrasound monitoring and treatment system provided in an embodiment of the present application;

[0065] FIG17 is a diagram illustrating signal phase modulation of electrical signals of different center frequencies in a mixed-frequency excitation modulation signal transmittable by an ultrasound monitoring treatment system provided in an embodiment of the present application.

[0066] Explanation of the accompanying drawings: 1-treatment part; 11-treatment working layer; 12-treatment matching layer; 13-backing part; 2-monitoring part; 21-monitoring working layer; 22-monitoring matching layer; 3-ultrasound isolation layer; 4-backing layer; 5-flexible PCB circuit board; 51-transducer pad; 6-temperature measuring part; 7-front packaging protective layer; 8-back packaging protective layer; 9-waterproof isolation layer; 101-wrapping part; 102-modified flexible skin-friendly packaging; 103-metal plate; 104-insulating protective layer; 105-support part; 106-elastic part; 107-tensioning part; 108-cooling part; 109-transducer. DETAILED DESCRIPTION

[0067] The following will clearly and completely describe the technical solution of this application in conjunction with the accompanying drawings. Obviously, the embodiments described are only part of the embodiments of this application, not all of them. Based on the embodiments in this application, all other embodiments obtained by ordinary technicians in this field without making any creative efforts are within the scope of protection of this application.

[0068] In the description of this application, it should be noted that the terms "center", "up", "down", "left", "right", "vertical", "horizontal", "inside", "outside", etc., indicating orientations or positional relationships, are based on the orientations or positional relationships shown in the accompanying drawings. They are only for the convenience of describing this application and simplifying the description, and do not indicate or imply that the device or element referred to must have a specific orientation, be constructed and operated in a specific orientation. Therefore, they cannot be understood as limitations on this application. In addition, the terms "first", "second", and "third" are used for descriptive purposes only and cannot be understood as indicating or implying relative importance. In addition, the technical features involved in the different embodiments of the present application described below can be combined with each other as long as they do not conflict with each other.

[0069] Example 1

[0070] This embodiment provides a transducer, as shown in Figures 1 and 2. The transducer includes a treatment element 1 and a monitoring element 2, both of which are connected to an external control circuit. The treatment element 1 is used to transmit ultrasonic waves to the area to be treated, utilizing the cavitation and mechanical effects of the ultrasonic waves to perform ablation treatment on the area to be treated; the monitoring element 2 is used to transmit ultrasonic waves to the area to be treated, using the ultrasonic waves to locate the treatment area in real time and monitor elastic mechanical changes, Doppler blood flow changes, and vascular recanalization information of the target tissue within the area to be treated, and to provide real-time feedback to the external control circuit to determine whether the target area has reached the required treatment dose during treatment and whether coagulative necrosis of the target tissue has occurred. The control circuit controls the treatment element 1 to adjust the optimal ultrasonic treatment parameters based on the preset treatment plan information.

[0071] As shown in FIG1 , the treatment element 1 includes a treatment working layer 11 and a treatment matching layer 12. The treatment working layer 11 is provided below the treatment matching layer 12. When a transducer is used for thrombolytic therapy, the treatment matching layer 12 is placed on the outside of the target skin of the area to be treated. The treatment working layer 11 is used to transmit ultrasonic waves to the area to be treated, and the cavitation effect and mechanical effect of the ultrasonic waves are used to perform ablation therapy on the area to be treated. This is a prior art, so its principle will not be described in detail here. The treatment matching layer 12 is provided between the treatment working layer 11 and the target skin. The treatment matching layer 12 is used to reduce the acoustic impedance difference between the treatment working layer 11 and the propagation medium (water or biological tissue), which can better realize the transmission of sound waves into the medium. The working principle of the treatment matching layer 12 here is also a prior art, so its principle will not be described in detail here.

[0072] As shown in Figure 1, the monitoring element 2 includes a monitoring working layer 21 and a monitoring matching layer 22. The monitoring working layer 21 is positioned below the monitoring matching layer 22. When using a transducer for ablation therapy, the monitoring matching layer 22 is placed outside the targeted skin of the treatment area. The monitoring working layer 21 is used to transmit ultrasound waves to the treatment area. Ultrasonic waves are used to locate and monitor elastic mechanical changes, Doppler blood flow changes, and vascular recanalization information in the target tissue within the treatment area in real time. These ultrasonic waves are then fed back to the external control circuit in real time to determine whether the target area has reached the required therapeutic dose during treatment and whether coagulative necrosis of the target tissue has occurred. The external control circuit controls the treatment element 1 to adjust the optimal ultrasound treatment parameters based on the preset treatment plan information. The monitoring working layer 21 is provided with an ultrasound generator, which is a prior art technology, so its principle will not be elaborated on here. The monitoring matching layer 22 is arranged between the monitoring working layer 21 and the target skin. The monitoring matching layer 22 is used to reduce the acoustic impedance difference between the monitoring working layer 21 and the propagation medium (water or biological tissue), which can better realize the transmission of sound waves into the medium. The working principle of the monitoring matching layer 22 here is also the existing technology, so its principle will not be elaborated here.

[0073] In this embodiment, as shown in Figure 1, the treatment element 1 and the monitoring element 2 are placed side by side, and a backing layer 4 is provided on the bottom sides of the treatment element 1 and the monitoring element 2. The backing layer 4 and the matching layer are arranged on opposite sides of the working layer. During treatment, the backing layer 4 is used to absorb the acoustic energy radiated back from the transducer, reducing the interference of the back-radiated signal on the external control circuit and improving the quality of the transmitted pulse. By placing the treatment element 1 and the monitoring element 2 side by side and sharing the backing layer 4, the shared backing layer 4 can effectively reduce the overall design size of the transducer. To prevent mutual interference of ultrasonic waves between the treatment element 1 and the monitoring element 2, an ultrasonic isolation layer 3 is provided between the treatment element 1 and the monitoring element 2. Interference between the treatment element 1 and the monitoring element 2 can also be reduced through time-sharing control.

[0074] In some other implementations of this embodiment, as shown in FIG2 , the treatment member 1 is configured to be cylindrical, and a cylindrical placement cavity is provided in the middle of the treatment member 1. The monitoring member 2 is also configured to be cylindrical and placed inside the placement cavity in the middle of the treatment member 1, and the treatment member 1 and the monitoring member 2 are placed coaxially. In this structure, the matching layers of the treatment member 1 and the monitoring member 2 are simultaneously arranged upward, and a backing layer 4 is provided only at the bottom of the treatment member 1 to absorb the backscattered acoustic wave signal of the transducer, so that the oscillation of the transducer can be stabilized as quickly as possible, thereby improving the quality of the transmitted acoustic wave pulse. At the same time, an ultrasonic isolation layer 3 is provided between the placement cavity wall and the monitoring member 2 to avoid mutual interference of ultrasonic waves between the treatment member 1 and the monitoring member 2, or it can also be controlled by over-time operation to reduce the interference problem between the treatment member 1 and the monitoring member 2. It can be understood that the shapes of the treatment member 1 and the monitoring member 2 are not limited to cylindrical, but can also be other shapes. Among them, the ultrasonic isolation layer is a PVC cavity or acrylic cavity or epoxy resin mixed hollow glass microspheres or high sound attenuation coefficient insulating material filled between the monitoring component and the placement cavity wall. The inside of the PVC cavity or acrylic cavity is filled with gas or vacuum. The thickness of the ultrasonic isolation layer 3 is N+1 / 2 wavelength of the therapeutic ultrasound, where N is a positive integer.

[0075] During the treatment process, the treatment working layer 11 and the monitoring working layer 21 can work simultaneously. The echo signal reflected by the targeted treatment area received by the monitoring working layer 21 is detected and processed by the filtering circuit in the external control circuit to obtain real-time treatment status information of the monitored targeted treatment area; or, in order to monitor the treatment area more accurately, the monitoring working layer can also monitor the treatment status of the targeted treatment area during the working interval of the treatment working layer 11 and feed it back to the external control circuit.

[0076] The transducer provided in this embodiment, wherein the treatment element 1 is a broadband treatment transducer (0.5-5MHz) or a multi-frequency transducer (base frequency 0.5-3.5MHz, intermediate frequency 1.5-11MHz, high frequency (2.5-20MHz), and the monitoring element 2 is a high-frequency monitoring transducer (8-20MHz); the high-frequency monitoring transducer is used to transmit ultrasound to the area to be treated, and to locate the treatment area in real time through ultrasound and monitor the elastic mechanical changes of the target tissue in the treatment area, Doppler blood flow changes, vascular recanalization information, etc., and to feed back to the external control circuit in real time to judge whether the target area is in the treatment process. The system monitors whether the required therapeutic dose has been achieved and whether coagulative necrosis of the target tissue has occurred, and provides real-time feedback to the external control circuit. The broadband therapeutic transducer provides excitation signals of different frequencies, phases, and intensities at different stages of treatment, such as single-frequency, mixed-frequency, and multi-frequency alternation. By changing the frequency and energy of the sound waves radiated by the transducer, precise treatment at a specific depth, direction, frequency, and intensity in the body can be achieved. The transducer can also be controlled to start and stop, that is, different treatment plans can be given by monitoring and identifying different stages of treatment: including increasing energy, changing the therapeutic ultrasound frequency, and shutting down ultrasound irradiation.

[0077] Example 2

[0078] This embodiment provides a wearable ultrasound device, as shown in FIG3 to FIG7 , including at least one set of treatment units, each treatment unit including a flexible PCB circuit board 5 and nine transducers in embodiment 1 connected in series.

[0079] In this embodiment, as shown in Figures 3 and 4, nine transducers are arranged in three rows, with three transducers in each row connected to the surface of the flexible PCB circuit board 5. The therapeutic elements 1 in the three transducers in each row are connected in series with an external control circuit through a wire, and the monitoring elements 2 in the three transducers in each row are also connected in series with an external control circuit through a wire. As a result, the monitoring elements 2 and therapeutic elements 1 of the nine transducers can be connected to the external control circuit to collect data monitored by the monitoring element 2 and control the therapeutic element 1 to emit ultrasonic waves.

[0080] By setting three transducers as a group and connecting them in series, and all three groups of transducers are individually connected to the external control circuit through wires, it is possible to achieve individual control of the three groups of transducers, and then achieve time-sharing control of different series groups, as well as frequency division control, to form a controllable radiation sound field range, sound field frequency components (single frequency, multi-frequency, mixed frequency) and radiation intensity.

[0081] Optionally, three transducers are connected in series as a group, which can increase the longitudinal ultrasonic treatment length, and three groups of transducers are arranged longitudinally at intervals and packaged to form a treatment unit, which increases the transverse ultrasonic treatment width; when installing the flexible PCB circuit board 5 and the transducer, the backing layer 4 of the transducer is fixedly connected to the surface of the flexible PCB circuit board 5.

[0082] It is understood that in other embodiments, other numbers of transducers may be provided, such as four or five transducers per group, or four or five transducers may be arranged longitudinally at intervals. The specific number may be determined based on the transducer requirements of the treatment plan.

[0083] As shown in Figure 5, the treatment unit also includes a front encapsulation protective layer 7, a rear encapsulation protective layer 8, and a waterproof isolation layer 9. The front encapsulation protective layer 7 and the rear encapsulation protective layer 8 are arranged on both sides of the flexible PCB circuit board 5. During encapsulation, the transducer on the surface of the flexible PCB circuit board 5 is placed toward the front encapsulation protective layer 7, and the waterproof isolation layer 9 is arranged between the rear encapsulation protective layer 8 and the flexible PCB circuit board 5. When the transducer is installed, the backing layer 4 of the transducer is connected to the surface of the flexible PCB circuit board 5, so that the matching layers of the treatment element 1 and the monitoring element 2 of the transducer are placed toward the front encapsulation protective layer 7.

[0084] Since the front encapsulation protective layer 7 is designed to adhere to the target skin during use, it must meet medical safety and temperature standards. Suitable materials include silicone patches, non-woven fabric patches, PET + hydrogel, and other proven medical materials. Furthermore, to enhance the effectiveness of ultrasound transmission, an ultrasound coupling agent tank can be provided to serve as a transmission path between the skin and the transducer.

[0085] The back packaging protective layer 8 of the transducer is made of a material with high thermal conductivity and good heat dissipation, which can effectively absorb the accumulated heat generated during the high-power operation of the transducer to avoid thermal damage to the tissue. At the same time, the material has high compliance and can be but is not limited to a water-cooled chamber. A waterproof isolation layer 9 is set between the water-cooled chamber and the flexible PCB circuit board 5 to prevent leakage from the water-cooled chamber and damage to the flexible PCB circuit board 5.

[0086] As shown in Figure 6, the treatment unit adopts a curved structure design, which can better fit the targeted skin of the limb where it is worn.

[0087] According to the characteristics of the distribution of different tissue lesions in clinical practice, the structure of the wearable ultrasound device can be flexibly designed. For example, for the ablation treatment of lower limb venous thrombosis, due to the characteristics of lower limb venous thrombosis blockage in the human body: long distance, variable direction, bending, etc., the wearable ultrasound device should be able to cover the treatment and monitoring of the entire segment of thrombosis. In this embodiment, as shown in Figure 7, five treatment units form a group arranged horizontally to increase the treatment length; three groups of treatment units are arranged vertically to increase the treatment width, and each treatment unit is connected to the external control circuit via a communication cable. According to the distribution characteristics of deep vein thrombosis in the lower limbs, multiple transducer monitoring and treatment groups are fixed at set positions on the wearable sheath, forming all-round and multi-angle ultrasound coverage irradiation and monitoring of the thrombus blocked segment.

[0088] As shown in Figure 7, all nine treatment units are secured to a wrapping member 101. To enhance the adaptability of the wearable ultrasound device to diverse populations, wrapping member 101 is constructed from commonly used sports knee pad materials, including but not limited to nylon and neoprene. These materials exhibit strong elasticity and scalability, and feature built-in spring support for enhanced support. Velcro is used on both the top and bottom ends of wrapping member 101, allowing for flexible attachment and adjustable tightness. In other embodiments, snaps, straps, and other methods can also be used to secure wrapping member 101 to the body.

[0089] As shown in Figure 3, the treatment unit also includes three temperature measuring components 6, which are evenly arranged on the sides of the three groups of treatment units to monitor the temperature rise status of the transducer in real time. The temperature measuring components 6 are thermistors, etc. The temperature measuring components 6 are connected to the external control circuit through signal transmission lines to transmit the temperature information of the temperature measuring components 6 to the external control circuit.

[0090] The wearable ultrasound device provided in this embodiment is fixed to a human limb via Velcro. As shown in FIG8 , three groups of treatment units are distributed around the limb. The ultrasound waves emitted from the transducers within the treatment units form an ultrasound irradiation area a that completely covers the targeted lesion. The arc-shaped structure of the treatment units converges the ultrasound beams on the targeted lesion, and the beams of multiple treatment units achieve full coverage and monitoring of the lesion. The monitoring element 2 in the transducer within the treatment unit monitors the status of the targeted lesion and provides real-time feedback to the external control circuit, which then makes decisions on the treatment plan for the treatment unit. Single-frequency treatments of varying intensities, directions, and depths can be provided, as well as multi-frequency or mixed-frequency treatment plans.

[0091] The wearable ultrasound device provided in this embodiment can be used in conjunction with the minimally invasive interventional catheter commonly used in clinical practice to precisely locate and administer drugs, perform microbubble-assisted thrombolysis, and through real-time monitoring of changes in thrombus status and vascular blood flow recanalization rate in the body, feedback adjustment and optimization of the ultrasound thrombolysis treatment plan can be performed, thereby solving the current problem of patients having to stay in bed for 5-7 days after thrombolytic catheter placement in clinical practice, greatly improving patient comfort. Wearable ultrasound assistance can accelerate the thrombolytic efficiency of clinical thrombolytic catheters, greatly reduce the retention time of thrombolytic catheters in the patient's body, and reduce the risks brought by the catheter. At the same time, with the assistance of ultrasound + microbubbles, the dosage of thrombolytic drugs can be greatly reduced, thereby reducing the side effects and complications caused by thrombolytic drugs.

[0092] It can be understood that the wearable ultrasound device provided in this embodiment is not only suitable for the treatment of deep vein thrombosis in the lower limbs, but can also be used to alleviate and treat other diseases, such as varicose veins, ultrasound-induced bone tissue regeneration, tumor ablation, and prostate disease treatment.

[0093] Example 3

[0094] This embodiment provides a wearable ultrasound device, as shown in Figures 9, 11, and 14. The treatment unit includes a modified flexible skin-friendly package 102, a transducer 109, a metal plate 103, and an insulating protective layer 104. The transducer 109 is disposed between the metal plate 103 and the modified flexible skin-friendly package 102, and is electrically connected to both the metal plate 103 and the modified flexible skin-friendly package 102. The insulating protective layer 104 is disposed between the metal plate 103 and the modified flexible skin-friendly package 102, and the transducer 109 is disposed within the insulating protective layer 104 to isolate the electrodes on both sides of the transducer 109.

[0095] In the wearable ultrasound device in the above embodiment, the modified flexible skin-friendly package 102 is made of Ecoflex or PDMS and carbon nanotubes or metal powder, so that the modified flexible skin-friendly package 102 has a certain degree of ductility and biosafety while also having a certain degree of conductivity. All transducer 109 bodies are located in the insulating protective layer 104, and one side electrode thereof is electrically connected to the modified flexible skin-friendly package 102. The bottom layer is a metal plate 103, and the material is a metal material with good ductility, such as copper, gold, etc. Among them, one side electrode of the transducer 109 is directly connected to the metal plate 103. On the one hand, the metal plate 103 can provide a reliable connection and stable electrical performance for the transducer 109, and can also improve the waveform stability of the transducer 109 and allow high-power current to pass through. On the other hand, the metal plate 103 can be a metal material with high thermal conductivity and ductility, such as copper or gold, and because there is a large area of ​​contact between the metal plate and the transducer 109, efficient heat dissipation can be achieved.

[0096] In this embodiment, as shown in FIG9 , the wire A and the wire B are electrically connected to the modified flexible skin-friendly package 102 and the metal plate 103 , respectively, and are controlled by an external host.

[0097] In this embodiment, a device for changing the spatial sound field radiation direction of a transducer is provided in the treatment unit to change the spatial sound field radiation direction of each transducer in the treatment unit.

[0098] In this embodiment, as shown in Figures 12 and 13, the transducer spatial sound field radiation direction changing device can be optionally an elastic member 106, which has an elastic force that drives the front packaging protective layer 7 to bend in an arc shape so that the front packaging protective layer 7 fits the targeted skin area to be treated.

[0099] In the above embodiment, the material of the elastic member 106 can be a metal material with a certain toughness and initial bending angle, such as nickel-titanium alloy. The main body of the elastic member 106 is located in the modified flexible skin-friendly package 102 or in the insulating protective layer 104, and the two ends of the elastic member 106 are fixed to the support plate. As shown in Figure 12, the elastic member 106 is in a bent state when it is not subjected to external force. Therefore, under the shape restriction of the elastic member 106, the treatment unit is in a maximum bending state, and the maximum bending state is considered to be the initial position of the overall structure (the dotted line position in Figure 12). When the overall structure is bent, the internal transducer 109 will form a centripetal focus, and the spatial sound field at a higher position is significantly superimposed and enhanced; therefore, this position is considered to be the main sound field superposition area (D in Figure 12), which is also the main treatment area.

[0100] In this embodiment, the elastic member 106 is disposed inside the treatment unit, and one of its functions is also to serve as a supporting frame inside the treatment unit.

[0101] In this embodiment, as shown in Figures 12 and 13, a tensioning member 107 is provided on the upper side of the treatment unit. The tensioning member 107 is connected by support plates on both sides and an elastic member 106, and the tensioning member 107 is configured to shorten under the action of an external force to pull the support plates and the elastic member 106 to reduce the bending angle of the front packaging protective layer 7.

[0102] In the above embodiment, the tensioning member 107 is a tensioning rope with adjustable length but no elasticity. The tensioning rope can be reduced in length by means of a ratchet knob, a pneumatic rod, or other methods. Under external influences, the tensioning rope shortens, causing the support plates at both ends of the elastic member 106 to be pulled upward by the tensioning rope, driving the elastic member 106 upward as well, thereby reducing the overall bending angle of the treatment unit to the position indicated by the solid line in FIG12. The lower bending angle reduces the main sound field superposition area (at D in FIG12). When the entire structure is pulled to a horizontal state, the transducers 109 transmit forward, and the main sound field superposition area reaches infinity, which is the maximum position. At the same time, since the elastic member 106 has a tendency to return to its initial state, this will keep the tensioning member 107 taut, thereby forming a state of equilibrium between the tensioning torque of the tensioning member 107 and the restoring torque of the elastic member 106, maintaining the stability of the entire structure.

[0103] Alternatively, when tensioning member 107 is relaxed and extended, elastic member 106 loses its tensioning torque. Consequently, under the action of the restoring torque, elastic member 106 automatically returns to a larger bending angle until tensioning member 107 is taut and reaches a new equilibrium state. During this process, as tensioning member 107 continues to extend, the bending angle of the overall structure increases, gradually increasing the area of ​​primary sound field overlap until elastic member 106 reaches its maximum bending angle. Thus, shortening tensioning member 107 achieves the function of reducing the bending angle and altering the sound field space.

[0104] In this embodiment, a heat dissipation structure is provided within the treatment unit to address the problem of excessive heat generation by the transducer assembly during prolonged operation. The heat dissipation structure may be a cooling element 108 as shown in FIG14 . Cooling element 108 is adapted to contact an external cooling source, or a cooling medium may be introduced into cooling element 108 .

[0105] In the above embodiment, to address the problem of excessive heat generation in the transducer assembly during prolonged operation, a cooling element 108 is provided within the treatment unit. Cooling element 108 utilizes a cooling channel or a metal sheet or metal rod with high thermal conductivity. Cooling element 108 is disposed within the modified flexible, skin-friendly package 102. When a cooling channel is employed, the transducer 109 is cooled by continuously injecting a cooling medium from the outside. The cooling medium is a liquid with a high specific heat capacity, such as water, and the cooling channel is a flexible material with a certain degree of thermal conductivity. When a metal sheet or metal rod with high thermal conductivity is employed, both ends of the metal sheet or metal rod are connected to an external cooling liquid, cooling the transducer 109 assembly through heat conduction.

[0106] Example 4

[0107] This embodiment provides a wearable ultrasound device, which differs from the embodiment 3 in that:

[0108] As shown in Figure 10, the treatment unit includes a modified flexible skin-friendly package 102, a flexible PCB circuit board 5, a transducer 109 and a metal plate 103. The transducer 109 is arranged between the flexible PCB circuit board 5 and the modified flexible skin-friendly package 102, and the transducer 109 is electrically connected to the flexible PCB circuit board 5 and the modified flexible skin-friendly package 102; the metal plate 103 is arranged on the side of the flexible PCB circuit board 5 away from the transducer 109, and the metal plate 103 is insulated from the flexible PCB circuit and the transducer 109.

[0109] Specifically, the flexible PCB 5 is connected to one electrode of the transducer 109, while the metal plate 103 is located beneath the flexible PCB 5 and is insulated from the transducer 109. The metal plate 103 serves as both a heat sink and a part of the matching layer of the transducer 109, effectively reducing the thickness of the transducer 109. One electrode of the transducer 109 is electrically connected to the modified flexible skin-friendly package 102, while the other electrode is connected to the flexible PCB 5. The flexible PCB and the modified flexible skin-friendly package 102 are insulated from each other. Therefore, the transducers 109 share only one electrode, allowing for separate control of transduction via the flexible PCB 5.

[0110] In this embodiment, as shown in Figure 11, the flexible PCB circuit board 5 includes a transducer pad 51, the transducer pad 51 includes positive and negative poles, the transducer 109 is arranged on the transducer pad 51, and the positive and negative poles of the transducer pad 51 are respectively suitable for electrical connection with the positive and negative poles on the transducer 109.

[0111] Specifically, the flexible PCB 5, except for the transducer pads 51, is covered with insulating oil, achieving complete electrical isolation between the transducers 109. The transducer pads 51 include positive and negative electrodes (two portions spaced apart in FIG. 11 ), which can match the positive and negative electrodes of the transducers 109. Specifically, the emitting surface of the transducer 109, which is plated with an insulating layer, can be extended by a metal coating such as silver, achieving electrical connection between the emitting surface of the transducer 109 and the positive electrode pad. Simultaneously, the negative electrode pad is directly connected to the negative electrode of the transducer 109, thereby achieving the location of the positive electrodes of the transducers 109 on the same surface. The flexible PCB 5 with the transducer pads 51 can avoid soldering wires on the emitting surface of the transducers 109, effectively improving the operating performance of the transducers 109. Because each group of transducers 109 is individually wired through the flexible PCB 5, it has independent electrical control.

[0112] The wearable ultrasound device of this embodiment provides two completely isolated electrical circuits. As shown in Figure 11 , the positive and negative electrodes of wire B (not shown) are connected to the positive and negative electrodes of transducer 109 via flexible PCB 5, forming one electrical circuit. The other electrical circuit is the modified flexible skin-friendly package 102-flexible PCB 5 circuit. Wire A (not shown) is connected to one electrode of transducer 109 via modified flexible skin-friendly package 102, while wire C (not shown) is connected to the other electrode of transducer 109 via a separate trace on flexible PCB 5, forming another electrical circuit. Generally, the flexible PCB 5 circuit in which wire B participates typically transmits power current for treatment, while the modified flexible skin-friendly package 102-flexible PCB 5 circuit in which wires A and C participate typically transmits imaging signals. This prevents crosstalk between the therapeutic power current and the imaging signal.

[0113] Example 5

[0114] This embodiment provides an ultrasound monitoring and treatment system, as shown in Figure 15, including any one of the wearable ultrasound devices in Examples 2 to 4, and a control and display component, an intelligent monitoring component, an ultrasound drive component, and a protection component electrically connected to the wearable ultrasound device.

[0115] In this embodiment, the control and display component includes a main panel status indicator, a display screen, a knob, a button, a display and a control circuit, and the control and display component is connected to the ultrasonic driving component via a UART interface.

[0116] The ultrasonic drive component includes a microcontroller circuit, a signal generating circuit, and a power amplifier circuit. The ultrasonic drive component is a central control and adjustment module that provides optimal treatment parameter settings for the treatment unit.

[0117] The intelligent monitoring component includes a communication circuit, a filtering circuit, a data acquisition or processing circuit, an AI algorithm learning, etc. Through the monitoring component 2 of the transducer in the treatment unit, it can locate and monitor the elastic mechanical changes of the target tissue in the treatment area, Doppler blood flow changes, vascular recanalization information, etc. in real time, and provide real-time feedback to the external control circuit to determine whether the target area has reached the required treatment dose during the treatment process and whether coagulative necrosis of the target tissue has been caused. The control circuit controls the signal generating circuit to transmit the optimal ultrasound treatment parameters according to the preset treatment plan information.

[0118] The ultrasound monitoring and treatment system also includes a protection component, which monitors the circuit system safety information and probe temperature rise information in real time based on the voltage and current sensors in the ultrasound monitoring and treatment system and the temperature measuring component 6 inside the treatment unit, and transmits it to the controller circuit to provide protection for the safe and stable operation of the system.

[0119] Figures 16 and 17 illustrate the frequency-mixing excitation modulation signals that can be emitted by the ultrasound monitoring and treatment system of this application. The purpose of frequency mixing is to stimulate the transducer to produce different sound field frequencies using electrical signals of different frequencies. Stimulation with these different sound field frequencies can significantly improve thrombolysis efficiency. Figure 16 illustrates the temporal alternation of stimulation with electrical signals of different center frequencies. Alternatively, the transmission can be alternatingly coded by designing a disproportionate duty cycle, with 1.5 MHz excitation followed by 2 MHz excitation, or with a pause followed by 2 MHz excitation. Figure 17 illustrates the phase modulation of electrical signals of different center frequencies to create a frequency-mixing signal. The 1.5 MHz and 2 MHz signals are phase-adjusted and superimposed to form a 1.5+2 MHz frequency-mixing excitation signal, which stimulates the transducer to emit a frequency-mixing sound field. Alternatively, the frequency modulation signals shown in Figure 16 can be combined to alternately stimulate the signals. This is understandable. The frequencies shown in the figure are merely illustrative of the frequency-mixing modulation method and are not necessarily 1.5 MHz and 2 MHz. This can also be expanded to include more frequency components to form a multi-frequency modulated excitation signal.

[0120] Obviously, the above embodiments are merely examples for clarity of explanation and are not intended to limit the implementation methods. Those skilled in the art will readily appreciate that other variations or modifications based on the above descriptions are possible. It is not necessary and impossible to enumerate all implementation methods here. Obvious variations or modifications arising therefrom remain within the scope of protection of this application.

Claims

1. A transducer, suitable for connecting to an external control circuit, characterized in that: include: At least one treatment element, including a treatment working layer, wherein the treatment working layer is suitable for emitting ultrasound to the area to be treated to assist ablation treatment; At least one monitoring member, including a monitoring working layer, wherein the monitoring working layer is adapted to transmit ultrasonic waves to the area to be treated, so as to locate the area to be treated in real time and monitor the treatment status of the area to be treated; An ultrasonic isolation layer, provided between the monitoring element and the treatment element; The treatment element and the monitoring element are suitable for being connected to an external control circuit, and the monitoring element feeds back the treatment status information of the monitored area to be treated to the external control circuit in real time, so that the external control circuit adjusts the direction and power of the ultrasonic wave emitted by the treatment element; The treatment component and the monitoring component are placed side by side, the treatment component and the monitoring component are of an integrated structure design and share a backing layer, the backing layer material impedance matches the treatment component; the treatment component also includes a treatment matching layer, which is arranged on the side of the treatment working layer away from the backing layer; the monitoring component also includes a monitoring matching layer, which is arranged on the side of the monitoring working layer away from the backing layer, and the treatment matching layer and the monitoring matching layer are arranged on the same side; or A placement cavity is provided inside the treatment piece, the monitoring piece is provided in the placement cavity, and the ultrasonic isolation layer is provided between the cavity wall of the placement cavity and the monitoring piece; the matching layers of the treatment piece and the monitoring piece are simultaneously provided upward, and a backing layer is provided only at the bottom of the treatment piece.

2. The transducer according to claim 1, characterized in that The ultrasonic isolation layer is a PVC cavity or an acrylic cavity or epoxy resin mixed hollow glass microspheres or a high sound attenuation coefficient insulating material filled between the monitoring component and the cavity wall, and the PVC cavity or acrylic cavity is filled with gas or vacuum.

3. The transducer according to claim 2, characterized in that The thickness of the ultrasonic isolation layer is N+1 / 2 wavelength of the therapeutic ultrasonic wave, where N is a positive integer.

4. The transducer according to claim 1, characterized in that The treatment working layer and the monitoring working layer work simultaneously, or the monitoring working layer monitors the treatment state of the area to be treated during the working interval of the treatment working layer, and feeds back to the external control circuit.

5. A wearable ultrasound device, characterized in that: It comprises at least one group of treatment units, wherein the treatment units comprise a flexible PCB circuit board and / or a metal plate and at least one transducer according to any one of claims 1 to 4, wherein the transducer is connected to the flexible PCB circuit board or the metal plate.

6. The wearable ultrasound device according to claim 5, characterized in that: The transducers are divided into several groups and arranged on the surface of the flexible PCB circuit board, and the transducers in any group are connected in series with each other and then connected to the external control circuit to achieve single frequency, multi-frequency or mixed frequency treatment.

7. The wearable ultrasound device according to claim 5, characterized in that: The treatment unit further comprises a modified flexible skin-friendly package, the transducer is arranged between the metal plate and the modified flexible skin-friendly package, and the transducer is electrically connected to the metal plate and the modified flexible skin-friendly package.

8. The wearable ultrasound device according to claim 7, characterized in that: The treatment unit further comprises an insulating protective layer, which is arranged between the metal plate and the modified flexible skin-friendly package, and the peripheral side of the transducer is arranged in the insulating protective layer.

9. The wearable ultrasound device according to claim 5, characterized in that: The treatment unit further includes a modified flexible skin-friendly package, the transducer is arranged between the flexible PCB circuit board and the modified flexible skin-friendly package, and the transducer is electrically connected to the flexible PCB circuit board and the modified flexible skin-friendly package; The metal plate is arranged on a side of the flexible PCB circuit board away from the transducer, and the metal plate is insulated from the flexible PCB circuit and the transducer.

10. The wearable ultrasound device according to claim 9, characterized in that: The flexible PCB circuit board includes a transducer pad, the transducer pad includes positive and negative poles, the transducer is arranged on the transducer pad, and the positive and negative poles of the transducer pad are respectively suitable for being electrically connected to the positive and negative poles on the transducer.

11. The wearable ultrasound device according to any one of claims 5 to 10, characterized in that: The treatment unit also includes a temperature measuring component, which is connected to the flexible PCB circuit board or the metal plate and is arranged on the same side as the transducer.

12. The wearable ultrasound device according to any one of claims 5 to 10, characterized in that: The treatment unit further comprises a front packaging protection layer and a rear packaging protection layer, wherein the front packaging protection layer and the rear packaging protection layer are arranged on both sides of the transducer.

13. The wearable ultrasound device according to claim 12, characterized in that: The transducer on the surface of the flexible PCB circuit board is arranged toward the front packaging protection layer, and the treatment unit also includes a waterproof isolation layer, which is arranged between the rear packaging protection layer and the flexible PCB circuit board.

14. The wearable ultrasound device according to claim 12, characterized in that: The treatment unit is provided with a device for changing the spatial sound field radiation direction of the transducer to change the spatial sound field radiation direction of each transducer in the treatment unit.

15. The wearable ultrasound device according to claim 14, characterized in that: The transducer spatial sound field radiation direction changing device is an elastic member, and the elastic member has an elastic force that drives the front packaging protection layer to bend in an arc shape, so that the front packaging protection layer fits the targeted skin of the area to be treated.

16. The wearable ultrasound device according to claim 15, characterized in that: It also includes a tensioning member, which is connected to the elastic member and is configured to shorten under the action of an external force to pull the elastic member so as to reduce the bending angle of the front packaging protection layer.

17. The wearable ultrasound device according to claim 12, wherein: The treatment unit is provided with a heat dissipation structure, which is suitable for contacting with an external cold source, or the heat dissipation structure is suitable for passing a cooling medium.

18. An ultrasound monitoring treatment system, characterized in that: The invention comprises the wearable ultrasonic device as described in any one of claims 5 to 17, and a control display component, an intelligent monitoring component, an ultrasonic driving component and a protection component electrically connected to the wearable ultrasonic device.

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