Focused ultrasound tissue ablation system
By using a multi-channel phased array transducer and a real-time imaging system, combined with cavitation bubble cloud technology, the shortcomings of deep tissue treatment and monitoring in traditional high-intensity focused ultrasound therapy have been solved. This has enabled high-precision and safe tissue fragmentation, expanded clinical applications, and reduced system cost and size.
Patent Information
- Authority / Receiving Office
- CN · China
- Patent Type
- Utility models(China)
- Current Assignee / Owner
- 上海翊昇医疗科技有限公司
- Filing Date
- 2025-07-29
- Publication Date
- 2026-07-24
Smart Images

Figure CN224540820U_ABST
Abstract
Description
Technical Field
[0001] This utility model relates to the field of medical device technology, and in particular to a focused ultrasound tissue fragmentation system. Background Technology
[0002] With the continuous development of medical technology, minimally invasive and non-invasive treatment methods have gradually become an important direction for clinical treatment. Although traditional surgical treatments are effective, they have problems such as large trauma, slow recovery, and many complications, which bring a significant physical and psychological burden to patients. In recent years, high-intensity focused ultrasound (HIFU) technology, as a non-invasive treatment method, has been widely used in clinical treatment due to its non-invasive, safe, and efficient characteristics.
[0003] Traditional high-intensity focused ultrasound (HIFU) uses high heat to focus and cause coagulative necrosis of tissue through thermal ablation. If the target area is too large, it can easily cause thermal damage to non-target areas; if the target area is too small, it can easily lead to incomplete removal of the target area, resulting in poor treatment effects.
[0004] Therefore, focused ultrasound cavitation is superior to thermal ablation because it effectively avoids thermal damage to the non-target area due to the mechanical rather than thermal effects of focused ultrasound cavitation.
[0005] However, existing focused ultrasound tissue fragmentation systems still have the following problems: First, deep tissue treatment is challenging, as ultrasound is easily affected by acoustic distortion (such as obstruction by the skull or ribs) when penetrating deep tissues, leading to focus shift or pressure attenuation; second, intraoperative monitoring is insufficient, as traditional ultrasound imaging cannot monitor cavitation effects in real time in areas obstructed by bone, posing a risk of off-target damage; and third, traditional power amplifier systems suffer from problems such as single-channel physical superposition mode leading to large system size and limited integration of multi-channel power amplifiers. Utility Model Content
[0006] To address the problems of large surgical trauma, slow recovery, challenges in treating deep tissues, insufficient intraoperative monitoring, poor system compatibility, thermal damage, and large size associated with traditional surgery, and to achieve technical effects such as improved treatment precision, enhanced intraoperative monitoring, and reduced system costs, this utility model provides a focused ultrasound tissue fragmentation system.
[0007] This invention provides a focused ultrasound tissue fragmentation system, comprising a transceiver focused ultrasound probe, a multi-degree-of-freedom moving device, and a tissue fragmentation workstation. The tissue fragmentation workstation is used to adjust the position of the focused ultrasound probe according to the region of interest, receive images of the region of interest, process the images, and control the focused ultrasound probe to emit pulse waves. The multi-degree-of-freedom moving device is connected to the tissue fragmentation workstation and is used to adjust the position of the transceiver focused ultrasound probe. The transceiver focused ultrasound probe is connected to both the multi-degree-of-freedom moving device and the tissue fragmentation workstation, and is used to generate cavitation bubble clouds in the tissue fragmentation area, locate the cavitation area, and fragment the tissue in the region of interest.
[0008] Preferably, cavitation bubble cloud is generated by focusing short pulses (1us to 100us) of high-intensity (25MPa to 40MPa negative sound pressure) of ultrasound energy emitted by a focused ultrasound probe into the tissue, producing tiny bubbles. Many tiny bubbles form a bubble cloud. The expansion and rupture process of the bubble cloud is called cavitation effect, i.e., cavitation bubble cloud. During the violent expansion and rupture of these tiny bubbles, the cells and tissue structures in the tissue are homogeneously destroyed.
[0009] Preferably, the integrated transceiver focused ultrasound probe is a high-intensity focused ultrasound multi-channel phased array probe, comprising a transducer base, a multi-channel transducer, an imaging device, and a filling layer; the transducer base includes a housing and a multi-channel transducer disposed inside the housing, wherein there are multiple multi-channel transducers uniformly arranged on the housing in a spherical array along the center of the housing; the imaging system is disposed on the housing; and the filling layer fills the space between the housing and the multi-channel transducer.
[0010] Preferably, the multi-degree-of-freedom moving device includes a 6-axis robotic arm that can move and rotate along the X, Y, and Z axes. The robotic arm has a maximum effective load of 12.5 kg, a moving range of 1300 mm, and a repeatability of ±0.05 mm.
[0011] Preferably, the tissue fragmentation workstation includes: a main body, a control system, and an electronic drive system, wherein the control system and the electronic drive system are disposed within the main body; the control system is connected to the electronic drive system, a transceiver focused ultrasound probe, and an imaging system; the electronic drive system is connected to the transceiver focused ultrasound probe and the multi-degree-of-freedom moving device, and is used to drive the transceiver focused ultrasound probe to emit pulse waves and drive the multi-degree-of-freedom moving device to move; the control system is used to control the imaging system to scan images of regions of interest in real time and to receive information fed back from the transceiver focused ultrasound probe and the imaging system.
[0012] Preferably, the tissue fragmentation workstation further includes a display and a control component, the control component and the display being connected to a control system.
[0013] Preferably, the electronic drive system includes: a data acquisition device, a control device, a phase synchronization management device, a power amplifier integration device, and a pulse voltage adjustment device, all mounted on an integrated circuit board;
[0014] The data acquisition device is used to acquire medical image data and pulse emission feedback data sent by the image acquisition device;
[0015] The control device is connected to the data acquisition device, pulse voltage adjustment device, and phase synchronization management device, and is used to set the following parameters, including tissue fragmentation space reconstruction, transmission frequency, digital isolation, heat dissipation, digital-to-analog conversion, voltage detection, current detection, temperature detection, and phase management.
[0016] The pulse voltage regulating device is used to emit pulse waves according to the command of the control device;
[0017] The power amplifier integration module is connected to the pulse voltage adjustment device and is used to complete the integration of 8 to 128 power amplifiers, receive synchronous trigger information, and output a start transmission pulse signal to the multi-angle focused ultrasound therapy system.
[0018] The phase synchronization management module is responsible for the communication interface with the user terminal and the transmission of phase information. It also performs the synchronization function of the multi-channel integrated module, and the phase of each channel is individually adjustable.
[0019] Preferably, the phase synchronization management module includes: a microprocessor, a phase distribution module, a power management module, a power status detection module, and an upstream and downstream device communication module. The microprocessor is connected to the upstream and downstream device communication module, the power status detection module, and the phase distribution module, and the power management module is disposed on the integrated circuit board.
[0020] Preferably, the bottom of the main body is provided with casters.
[0021] Preferably, a power source is provided inside the main body, and the power source is connected to the electronic drive system.
[0022] Preferably, both the main body and the integrated transceiver focused ultrasound probe are equipped with handrails.
[0023] Preferably, the substrate includes a connecting rod and a scanning head, the connecting rod being connected to the multi-degree-of-freedom moving device; the bottom of the scanning head is a bare structure, and multiple mounting mechanisms arranged in an array are uniformly disposed inside the scanning head, with the multi-channel transducer disposed within the mounting mechanism.
[0024] Preferably, the imaging system includes: an image acquisition unit, a clamp, and a linear rotary motion mechanism connected in sequence. The image acquisition unit passes through the center of the scanning head, and an elastic sealing structure is provided between the scanning head and the image acquisition unit. The linear rotary motion mechanism is connected to the electronic drive system.
[0025] Preferably, the multi-channel transducer comprises 64 to 1024 transducer units, wherein the number of transducer units is an even number.
[0026] Preferably, the inner surface of the bare structure of the scanning head is a self-focusing arc-shaped surface.
[0027] Preferably, the transducer unit includes: a housing, a piezoelectric ceramic substrate, a backing layer, a signal transmission unit, and a multilayer acoustic impedance matching layer. The housing is connected to the mounting structure. An opening is provided at the bottom of the housing. The piezoelectric ceramic substrate is disposed in the middle of the housing. The multilayer acoustic impedance matching layer is disposed on the surface of the piezoelectric ceramic substrate facing the opening. The backing layer is disposed on the surface of the piezoelectric ceramic substrate facing away from the opening. The piezoelectric ceramic substrate is used to transmit pulses after being connected to the signal transmission unit.
[0028] Preferably, the control system includes a multi-channel signal generator, a multi-channel power amplifier, a multi-channel impedance matching network, a multi-channel delay controller, and a central processing unit. The central processing unit and the tuning circuit are connected to the multi-channel signal generator, the multi-channel power amplifier, the multi-channel impedance matching network, and the multi-channel delay controller, and are used to control the ultrasonic frequency, amplitude, phase, pulse duration, and pulse repetition frequency emitted by the transducer unit.
[0029] The beneficial effects of the solution provided in this application include at least the following:
[0030] 1. Significantly Improved Treatment Precision: This invention utilizes a multi-channel phased array transducer (64-1024 elements) and precise electronic phased array technology to control the focal size of tissue fragmentation at the subwavelength level (approximately half beamwidth), with a deep target area positioning error of less than 0.5 mm, far superior to traditional ultrasound treatment equipment. Simultaneously, the multi-channel focused ultrasound probe can monitor the cavitation threshold in real time, and the imaging system can detect the cavitation location in real time, effectively avoiding damage to non-target areas and improving treatment safety.
[0031] 2. Significantly expanded clinical application scope: This utility model can effectively penetrate acoustic barriers such as the skull and ribs through phase correction technology, making the system applicable to the treatment of intra-abdominal diseases such as liver cancer, kidney cancer, and pancreatic cancer, as well as brain diseases such as Parkinson's disease, essential tremor, glioma, epilepsy, and depression.
[0032] 3. Significant advantages compared to traditional HIFU treatment: This invention's tissue fragmentation technique is based on mechanical rather than thermal effects, effectively avoiding thermal diffusion, overheating of the sound field front and back fields, and thermal damage to non-target areas. Only tissues exceeding the cavitation effect threshold will be fragmented. Furthermore, the cavitation effect is tissue-selective, avoiding damage to tissues with high elastic modulus, such as blood vessels and bile ducts, making the treatment safer.
[0033] 4. Improved real-time imaging and accuracy: By adopting real-time ultrasound guidance and CT / MR image registration, CT / MR images are scanned before the operation, and the ultrasound images are fused and registered through image feature points. Compared with traditional ultrasound guidance, this increases accuracy, and compared with MR-guided HIFU treatment, it increases real-time performance and reduces the occupation of medical resources for MR.
[0034] 5. Reduced treatment time: This invention utilizes high-intensity short-pulse excitation in tissue fragmentation to generate a cloud of bubbles with extremely high negative sound pressure. As the bubbles are generated and collapse, homogenized tissue fragments are formed. Compared with the traditional HIFU continuous wave method, the treatment time is shortened by more than 30% by accumulating heat over a long period of time, raising the tissue temperature to above 57°C, causing protein coagulation necrosis, and then waiting for cooling.
[0035] 6. Modular innovation advantages of power amplifier system: This utility model solves the problem of the limited number of channels in multi-channel power amplifier integration, realizes multi-channel modular multiplexing and high-density integration, and enables phase synchronization between multiple channels, improving phase control accuracy. At the same time, it realizes the adjustment of independent channel frequency, power, phase delay and pulse repetition frequency. The system is highly integrated, the size is significantly reduced and it is flexible and easy to use. Attached Figure Description
[0036] The accompanying drawings, which are included to provide a further understanding of the present invention and constitute a part of this invention, illustrate exemplary embodiments of the present invention and, together with the description thereof, serve to explain the present invention and do not constitute an undue limitation thereof. In the drawings:
[0037] Figure 1 This is a schematic diagram of the structure of the multi-angle focused ultrasound therapy system 100;
[0038] Figure 2-5 A schematic diagram of the structure of a transceiver integrated focused ultrasound probe 110;
[0039] Figure 6 A cross-sectional view of the integrated transceiver focused ultrasound probe 110;
[0040] Figure 7 This is a schematic diagram of the imaging system 113;
[0041] Figure 8This is a schematic diagram of the linear rotary motion mechanism;
[0042] Figure 9 This is a schematic diagram of the transducer unit 1121;
[0043] Figure 10 This is a block diagram of the electronic drive system 133;
[0044] Figure 11 A diagram showing the inner diameter of a ring array;
[0045] Figure 12 This is a schematic diagram of the structure of the piezoelectric ceramic substrate 11213;
[0046] The following explains the reference numerals in the attached figures:
[0047] The system comprises a focused ultrasound tissue fragmentation system 100, a transceiver focused ultrasound probe 110, a substrate 111, a central circular hole 1111, a connecting rod 1112, a scanning head 1113, a mounting mechanism 1114, a positioning hole 11141, a multi-channel transducer 112, a transducer unit 1121, a positioning post 11211, a housing 11212, a piezoelectric ceramic substrate 11213, a piezoelectric ceramic element 112131, a piezoelectric ceramic filler layer 112132, a piezoelectric ceramic base 112133, and a backing layer 11214. Signal transmission unit 11215, multi-layer acoustic impedance matching layer 11216, high impedance matching layer 61, medium impedance matching layer 62, low impedance matching layer 63, imaging system 113, image acquisition unit 1131, clamp 1132, left clamp 1, right clamp 2, upper cover 3, lower cover 4, linear rotary motion mechanism 1133, servo motor 5, servo electric push rod 6, hollow shaft ball spline shaft 7, filling layer 114, multi-degree-of-freedom moving device 120, tissue fragmentation workstation 130, body 131, control Control system 132, electronic drive system 133, data acquisition device 310, filter 311, amplifier 312, sampler 313, first analog-to-digital converter 314, control device 320, FPGA development board 321, FPGA chip 3211, clock generation module 3212, clock distribution module 3213, cavitation space reconstruction module 322, phase generation module 323, digital isolation module 324, communication management module 325, heat dissipation module 326, voltage detection module 327, current detection module Module 328, temperature detection module 329, second analog-to-digital converter 3210, phase synchronization management device 330, microprocessor 331, phase distribution module 332, power management module 333, power status detection module 334, upstream and downstream equipment communication module 335, power amplifier integrated device 340, pulse wave voltage output module 341, third digital-to-analog converter 3411, pulse wave voltage analog output module 3412, pulse voltage adjustment device 350, harmonic matching module 360, high frequency filtering module 370. Detailed Implementation
[0048] To make the objectives, technical solutions, and advantages of this utility model clearer, the technical solutions of this utility model will be clearly and completely described below in conjunction with specific embodiments and corresponding drawings. Obviously, the described embodiments are only a part of the embodiments of this utility model, and not all of them. Based on the embodiments of this utility model, all other embodiments obtained by those skilled in the art without creative effort are within the scope of protection of this utility model.
[0049] The following drawings will disclose several embodiments of this utility model. For clarity, many practical details will be described in the following description. However, it should be understood that these practical details should not be used to limit this utility model. That is, in some embodiments of this utility model, these practical details are not essential. In addition, for the sake of simplicity, some conventional structures and components will be shown in the drawings in a simple schematic manner.
[0050] Example 1:
[0051] like Figure 1 As shown, a focused ultrasound tissue fragmentation system 100 includes a transceiver focused ultrasound probe 110, a multi-degree-of-freedom (DOF) moving device 120, and a tissue fragmentation workstation 130. The transceiver focused ultrasound probe 110 is connected to an image acquisition device 200, the multi-DOF moving device 120, and the tissue fragmentation workstation 130, respectively. The multi-DOF moving device 120 is connected to the tissue fragmentation workstation 130. The system adjusts the position of the focused ultrasound probe according to the region of interest (ROI), receives images of the ROI, processes the images, controls the focused ultrasound probe to emit pulse waves, generates cavitation bubble clouds in the cavitation region, locates the cavitation region, and performs cavitation on the tissue in the ROI.
[0052] like Figure 1-6 As shown, the transceiver integrated focused ultrasound probe 110 is a high-intensity focused ultrasound multi-channel phased array probe, including a substrate 111, and a multi-channel transducer 112 and an imaging system 113 disposed inside the substrate 111. The multi-channel transducer 112 is uniformly arranged in a circular array on the substrate 111 along the center of the substrate 111. The multi-channel transducer 112 includes multiple sets of transducer units 1121, and the transmitting end of the transducer unit 1121 is fan-shaped, rectangular, or trapezoidal. The imaging system 113 is disposed on the substrate 111. Preferably, the imaging system 113 extends out from the central circular hole 1111 of the substrate 111. A filling layer 114 fills the space between the substrate 111 and the multi-channel transducer 112 to reduce energy loss during sound wave propagation and improve sound wave transmission efficiency. The transducer base is made of aluminum alloy or stainless steel, which has properties such as corrosion resistance, high strength and good thermal conductivity. Guide posts and snap ring grooves are machined on the outer shell to fix the transducer unit 1121 to the transducer base.
[0053] The substrate 111 includes a connecting rod 1112 and a scanning head 1113. The connecting rod 1112 is connected to the multi-degree-of-freedom moving device 120. The bottom of the scanning head 1113 is a hollow structure. Multiple mounting mechanisms 1114 are evenly arranged in an array inside the scanning head 1113, and the multi-channel transducer 112 is disposed within the mounting mechanism 1114. The inner surface of the hollow structure of the scanning head 1113 is a self-focusing arc-shaped surface, a design that facilitates the focusing and propagation of ultrasonic waves. The design of the mounting mechanism 1114 ensures that the transducer unit 1121 can be securely fixed to the substrate 111, while facilitating maintenance or replacement when needed.
[0054] like Figure 6 As shown, the imaging system 113 includes: an image acquisition unit 1131, a clamp 1132, and a linear rotary motion mechanism 1133 connected in sequence. The image acquisition unit 1131 extends out of the central circular hole 1111 of the scanning head 1113. An elastic sealing structure 1134 is provided between the scanning head 1131 and the image acquisition unit 1131. The linear rotary motion mechanism 1133 is connected to the electronic drive system 133.
[0055] like Figure 7 As shown, the image acquisition device 1131 is an abdominal ultrasound probe capable of acquiring two-dimensional / three-dimensional images; the clamp 1132 includes a left clamp 1, a right clamp 2, an upper cover 3, and a lower cover 4, which together clamp the image acquisition device 1131. The left clamp 1 and right clamp 2 have two sealing ring grooves on their outer peripheries, and a waterproof gland can be installed on the lower cover, together forming a seal.
[0056] like Figure 8 As shown, the linear rotary motion mechanism 1133 includes: a servo motor 5, a servo electric push rod 6, and a hollow shaft ball spline shaft 7. The servo motor 5 is connected to the servo electric push rod 6 and the hollow shaft ball spline shaft 7 respectively. The servo motor 5 is used to control the hollow shaft ball spline shaft 7 to translate along the spline groove. The servo motor 5 is also used to drive the hollow shaft ball spline shaft 7 to rotate. One end of the hollow shaft ball spline shaft 7 is connected to the clamp 1132. With the above configuration, the electronic drive system 133 can simultaneously realize the linear motion and 360° rotation motion of the image acquisition device 1131 by driving the servo motor 5.
[0057] The multi-channel transducer 112 includes multiple sets of transducer units 1121, each set of transducer units 1121 being uniformly arranged in a circular array along the center of the substrate 111. Each set of transducer units 1121 constitutes an independent communication channel, and the radius of the circular array formed by each set of transducer units 1121 is different. This design enables the probe to achieve multi-focal, multi-depth ultrasound focusing, improving the accuracy and efficiency of tissue fragmentation.
[0058] The mounting mechanism 1114 is a groove for fixing the transducer unit 1121. The depth of the groove is 0.8-1.2 times the thickness of the transducer unit 1121, and the width is basically the same as the diameter of the transducer unit 1121. It is connected by a through gap. The spacing between the grooves is 1.5-2 times the diameter of the transducer unit 1121. To facilitate positioning and installation, positioning posts 11211 are provided on the transducer unit 1121, and positioning holes 11141 are opened next to the grooves. The positioning posts 11211 are inserted into the positioning holes 11141 for connection.
[0059] The surface of the substrate 111 is coated with a sound-absorbing coating with a thickness of 0.5-1mm.
[0060] like Figure 10 As shown, the transducer unit 1121 includes a housing 11212, a piezoelectric ceramic substrate 11213, a backing layer 11214, a signal transmission unit 11215, and a multilayer acoustic impedance matching layer 11216. The housing 11212 is connected to the mounting structure, and an opening is provided at the bottom of the housing 11212. The piezoelectric ceramic substrate 11213 is disposed in the middle of the housing 11212. A multilayer acoustic impedance matching layer 11216 is disposed on the surface of the piezoelectric ceramic substrate 11213 facing the opening, and a backing layer 11214 is disposed on the surface of the piezoelectric ceramic substrate 11213 facing away from the opening. The piezoelectric ceramic substrate 11213 is used to transmit pulses after being connected to the signal transmission unit 11215. The signal transmission unit 11215 is a signal transmission cable, and the backing layer 11214 is an acoustic attenuation layer. The acoustic attenuation layer can effectively absorb the back sound waves, prevent sound wave reflection interference, and improve the directional transmission effect of ultrasonic waves.
[0061] The multilayer acoustic impedance matching layer 11216 includes a high-impedance matching layer 61, a medium-impedance matching layer 62, and a low-impedance matching layer 63, which are arranged sequentially along the piezoelectric ceramic substrate 11213 towards the opening. This multilayer acoustic impedance matching structure can reduce the acoustic impedance layer by layer, minimizing energy loss during the transmission of sound waves from the piezoelectric ceramic substrate 11213 to human tissue, thereby improving the efficiency of sound energy utilization.
[0062] The transducer unit 1121 can be fan-shaped or rectangular. In a preferred embodiment, the transducer unit 1121 adopts a fan-shaped design, which allows the transducer unit 1121 to be better arranged along the circumferential direction to form a complete ring array, thereby improving the focusing effect of sound waves.
[0063] If the transducer element is circular, with a diameter of Φ10, and the base area is 46639 mm² 2 The effective launch area is 20410 mm². 2The effective launch area accounts for 43.8%; if a square array element with a side length of 10.4 mm has a base area of 46639 mm². 2 Effective launch area 28121.6mm 2 The effective launch area accounts for 60.3%; if a full array of fan-shaped elements is used, the base area is 46639 mm². 2 The effective launch area is 30996.3 mm². 2 The effective emission area accounts for 66.5%, indicating that the effective emission area of the fan-shaped transducer unit is larger and the treatment effect is better. Since it is necessary to ensure that the annular area of each group of transducer units is the same, it requires creative labor from the inventor and is not common knowledge or conventional technical means in this field.
[0064] The annular area of each transducer unit 1121 is the same or similar, with an error of ≤1%. This design ensures that the acoustic energy emitted by each transducer unit 1121 is uniformly distributed, avoiding energy unevenness caused by area differences, and improving the stability and consistency of focused ultrasound.
[0065] like Figure 11 As shown, when the transducer unit 1121 is fan-shaped, the inner diameter of the annular array formed by each group of transducer units 1121 is calculated as follows:
[0066] S=α[(H+φ / 2) 2 -(φ / 2) 2 ];
[0067] α = 360 / N;
[0068] Where S represents the sector area, H represents the sector width, α represents the sector angle of a single transducer, N represents the number of transducer units 1121 in each group, and φ represents the inner diameter of each transducer unit 1121.
[0069] The innermost ring's inner diameter φ1 and width H1 are obtained through measurement. The width H1 of the innermost ring element can be calculated from the innermost ring's inner diameter φ1. The inner diameter φ2 of the outermost ring is determined by adding the assembly gap l1 between each ring to the width H1 of the innermost ring element; and so on. Following this calculation method, the sector width H and inner diameter φ of all rings are calculated. This calculation method ensures that the transducer unit 1121 in each ring array has a consistent area, guaranteeing uniform distribution of acoustic energy.
[0070] The multi-channel transducer 112 comprises 64 to 1024 transducer units 1121, with the number of transducer units 1121 being an even number. In a preferred embodiment, the multi-channel transducer 112 comprises 256 transducer units 1121 distributed across four ring arrays, each ring array containing 64 transducer units 1121. This configuration enables high-precision acoustic focusing control, meeting the needs of tissue fragmentation at different depths and sizes.
[0071] like Figure 12 The piezoelectric ceramic substrate 11213 shown includes a piezoelectric ceramic element 112131, a piezoelectric ceramic filler layer 112132, and a piezoelectric ceramic base 112133. The piezoelectric ceramic element 112131 is made of lead zirconate titanate (PZT)-based piezoelectric ceramic material, and the PZT-based piezoelectric ceramic is selected from PZT-4 or PZT-8. The thickness of the piezoelectric ceramic element 112131 is 0.5-1.5 mm. The filler layer 112132 is made of epoxy resin or reactive polymer and has a thickness of 2-3 mm. The piezoelectric ceramic base 112133 adopts a type 1-3 connection structure and has a thickness of 0.5-1 mm. m; the thickness of the high impedance layer is 10-14 MRayl, the thickness of the medium impedance layer is 6-8 MRayl, and the thickness of the low impedance layer is 2 MRayl; the thickness of the backing layer 11214 is 8-12 MRayl; the adjustment range of the dual-terminal multi-stage LC tuning circuit is 1-3 MHz; as described above, the type 1-3 piezoelectric composite material is used as the piezoelectric ceramic substrate 112133, and the piezoelectric ceramic element 112131 is combined with the passive polymer of epoxy resin or active polymer to prepare the piezoelectric composite material to form the piezoelectric ceramic substrate 11213, so as to achieve a lower acoustic impedance and a higher coupling coefficient.
[0072] When this focused ultrasound tissue fragmentation probe is in operation, the control system 132 sends electrical signals of different phases to each transducer unit 1121. The piezoelectric ceramic substrate 11213 generates ultrasonic waves under the excitation of the electrical signals. A multi-layer acoustic impedance matching layer 11216 ensures efficient transmission of ultrasonic waves, and the ring array design of the multi-channel transducers 112 enables the ultrasonic waves to form a focal point at a specific depth, generating sufficient acoustic energy density to fragment the target tissue. By adjusting the phase difference of different ring arrays, the position and shape of the focal point can be changed, achieving precise fragmentation of tissues of different depths and sizes.
[0073] The multi-degree-of-freedom moving device 120 includes a robotic arm that can move and rotate along the X, Y, and Z axes. This design allows the focused ultrasound probe to approach the treatment area from any angle, greatly improving the flexibility and precision of treatment. The robotic arm is driven by a high-precision stepper motor with dual encoder feedback to ensure accurate positioning for each movement and rotation.
[0074] The tissue fragmentation workstation 130 includes a main body 131, a control system 132, and an electronic drive system 133, with the control system 132 and electronic drive system 133 housed within the main body 131. The control system 132 is connected to the electronic drive system 133, a transceiver focused ultrasound probe 110, and an imaging system 113. The electronic drive system 133 is connected to the transceiver focused ultrasound probe 110 and a multi-degree-of-freedom motion device 120, and is used to drive the transceiver focused ultrasound probe 110 to emit pulse waves and drive the multi-degree-of-freedom motion device 120 to move. The control system 132 is used to control the imaging system 113 to capture images of the region of interest and to receive information from the transceiver focused ultrasound probe 110 and the imaging system 113.
[0075] The control system 132 includes a multi-channel signal generator, a multi-channel power amplifier, a multi-channel impedance matching network, a multi-channel delay controller, and a central processing unit (CPU). The CPU and tuning circuit are connected to the multi-channel signal generator, multi-channel power amplifier, multi-channel impedance matching network, and multi-channel delay controller to control the frequency, amplitude, phase, pulse time, and pulse repetition frequency of the ultrasound emitted by the transducer unit 1121. This design enables the system to precisely control the operating state of each transducer unit 1121, achieving complex focusing modes and treatment protocols.
[0076] The electronic drive system 133 includes a data acquisition device 310, a control device 320, a phase synchronization management device 330, a power amplifier integrated device 340, and a pulse voltage regulation device 350, all mounted on an integrated circuit board.
[0077] The data acquisition device 310 is used to acquire medical image data and pulse emission feedback data sent by the image acquisition device. The data acquisition device 310 includes a filter 311, an amplifier 312, a sampler 313, and a first analog-to-digital converter 314 connected in sequence. The first analog-to-digital converter 314 is connected to the control device 320. Specifically, the filter 311 is a bandpass filter used to filter out unwanted frequency signals, retaining only signals in specific frequency bands; the amplifier 312 is a gain amplifier used to amplify weak signals to a suitable amplitude for processing; the sampler 313 is a high-speed sampler capable of sampling signals at high frequencies to ensure signal integrity; and the first analog-to-digital converter 314 is a high-speed analog-to-digital converter that converts analog signals into digital signals for processing by the control device 320.
[0078] The control device 320 is connected to the data acquisition device 310, the pulse voltage regulation device 350, and the phase synchronization management device 330, and is used to set the following parameters, including tissue fragmentation space reconstruction, transmission frequency, digital isolation, heat dissipation, digital-to-analog conversion, voltage detection, current detection, temperature detection, and phase management. The control device 320 includes an FPGA development board 321, a cavitation space reconstruction module 322, a phase generation module 323, a digital isolation module 324, a communication management module 325, a heat dissipation module 326, a voltage detection module 327, a current detection module 328, a temperature detection module 329, and a second analog-to-digital converter 3210. The FPGA development board 321 is connected to the cavitation space reconstruction module 322, the phase generation module 323, the digital isolation module 324, the communication management module 325, and the heat dissipation module 326. The communication management module 325 is connected to the phase synchronization management module. The voltage detection module 327, current detection module 328, temperature detection module 329, and second analog-to-digital converter 3210 are all mounted on an integrated circuit board, and the voltage detection module 327, current detection module 328, and temperature detection module 329 are all connected to the second analog-to-digital converter 3210.
[0079] The FPGA development board 321 includes an FPGA chip 3211, a clock generation module 3212, and a clock distribution module 3213, all mounted on an integrated circuit board. The FPGA chip 3211, clock generation module 3212, and clock distribution module 3213 are connected sequentially. The FPGA chip 3211 is responsible for processing various digital signals and control logic. The clock generation module 3212 generates the reference clock signal required by the system. The clock distribution module 3213 distributes the clock signal to the various parts of the system that need synchronization, ensuring that the entire system operates in the same clock domain and guaranteeing the synchronization of signal processing.
[0080] During tissue fragmentation treatment, the pulse voltage adjustment device 350 is used to emit pulse waves according to the command of the control device 320.
[0081] The power amplifier integration device 340 is connected to the pulse voltage adjustment device 350 to complete the integration of 8 to 128 power amplifiers, receive synchronization trigger information, and output a start-transmission pulse signal to the multi-angle focused ultrasound therapy system 100. The power amplifier integration device 340 is a pulse wave voltage output module 341, which is connected to the control device 320. The pulse wave voltage output module 341 includes a third digital-to-analog converter 3411 and a pulse wave voltage analog output module 3412, and the third digital-to-analog converter 3411 is connected to both the control device 320 and the pulse wave voltage analog output module 3412. The third digital-to-analog converter 3411 converts the digital signal output by the control device 320 into an analog signal, which is amplified by the pulse wave voltage analog output module 3412 and finally output to the focused ultrasound probe.
[0082] The phase synchronization management device 330 is responsible for the communication interface with the user terminal and the transmission of phase information. It also performs synchronization of multiple integrated modules, with each channel's phase individually adjustable. The phase synchronization management device 330 includes a microprocessor 331, a phase distribution module 332, a power management module 333, a power status detection module 334, and an upstream / downstream device communication module 335. The microprocessor 331 is connected to the upstream / downstream device communication module 335, the power status detection module 334, and the phase distribution module 332. The power management module 333 is mounted on an integrated circuit board. The microprocessor 331 processes instructions from the user terminal and converts them into phase control signals; the phase distribution module 332 distributes phase information to each channel; the power management module 333 ensures a stable power supply to the system; the power status detection module 334 monitors the power status in real time to ensure safe system operation; and the upstream / downstream device communication module 335 is responsible for data exchange with the user terminal and other devices.
[0083] The focused ultrasound electronic drive system 133 also includes a harmonic matching module 360, which is connected to the power amplifier integrated device 340. The harmonic matching module 360 is used to match the impedance between the power amplifier output and the ultrasonic transducer, reducing signal reflection and improving energy transmission efficiency. In addition, the system also includes a high-frequency filtering module 370, which is connected to both the harmonic matching module 360 and the focused ultrasound transducer. The high-frequency filtering module 370 is used to filter out high-frequency noise and harmonics, ensuring the purity of the output signal and reducing interference to surrounding electronic equipment.
[0084] During system operation, the data acquisition device 310 first acquires medical image data and feedback data. After filtering, amplification, sampling, and analog-to-digital conversion, the data is transmitted to the control device 320. The control device 320 sets corresponding parameters based on this data, processes it through the FPGA development board 321, and controls the pulse voltage adjustment device 350 to select an appropriate operating mode. The power amplifier integrated device 340, according to the instructions from the control device 320, generates the required drive signal through a corresponding digital-to-analog converter and voltage output module. The phase synchronization management device 330 ensures phase synchronization of the multi-channel signals. After the harmonic matching module and high-frequency filtering module process the signals, the drive signal is finally output to the multi-angle focused ultrasound therapy system 100 to achieve precise focused ultrasound therapy. Compared with existing conventional single-transmitter transducers, the transceiver integrated focused ultrasound probe 110 has a narrower bandwidth, while the transceiver integrated transducer has a wider bandwidth. Utilizing the wideband characteristics of the transceiver transducer, cavitation detection can be performed. After processing with a spatial reconstruction algorithm, the cavitation location can be spatially pinpointed. Even if ultrasound imaging is obstructed by ribs, cavitation location can ensure the safety of the process. Regarding the system processing mechanism, such as... Figure 7Functionally, it is divided into a receiving array and a transmitting array. Since the cavitation signal has a low swing fixed frequency characteristic, it is necessary to perform bandpass filtering to select the characteristic frequency signal. After amplification, the characteristic frequency signal meets the amplitude characteristics of its high-speed sampling. The high-speed AD converter quantizes and encodes the cavitation signal and sends it to the cavitation space reconstruction unit through the high-speed interface to complete the spatial positioning of the cavitation position.
[0085] The transmitting array transmits pulsed waves (PWD), and the voltage can be infinitely amplified by voltage DA adjustment, thus amplifying the pulsed waves. The design uses a high-efficiency Class D power amplifier (theoretically 100% efficient) to drive the transducer. The power amplifier output signal of the transducer needs to pass through a resonant matched two-port network to achieve maximum power transmission.
[0086] The tissue fragmentation workstation 130 also includes a display and a control unit, with the control unit connected to the display. The display shows real-time images of the treatment area and treatment parameters. The control unit includes buttons, a keyboard, a mouse, and a screen for easy operation and parameter adjustment. Casters are provided at the bottom of the main body 131 for easy movement and positioning of the entire system. An internal power supply is located in the main body 131 and is connected to the electronic drive system 133, providing a stable power supply for the entire system. Handrails are provided on both the main body 131 and the transceiver focused ultrasound probe 110 for easy operation and movement by medical personnel.
[0087] During use, the image acquisition device 200 first scans the patient's region of interest to acquire two-dimensional or three-dimensional images. Then, the control system 132 of the tissue fragmentation workstation 130 processes the acquired images to locate the area requiring treatment. Next, the multi-degree-of-freedom motion device 120 adjusts the position and angle of the focused ultrasound probe to align it with the treatment area. Finally, the control system 132 controls the focused ultrasound probe to emit pulse waves, generating cavitation bubble clouds in the target area for precise cavitation of the tissue.
[0088] Throughout the treatment process, the system can monitor the treatment effect in real time and adjust the treatment parameters as needed to ensure the safety and effectiveness of the treatment. The design of the focused ultrasound tissue fragmentation system makes ultrasound treatment more precise and efficient, greatly reducing damage to surrounding healthy tissues and improving treatment safety and patient comfort.
[0089] Example 2:
[0090] This embodiment provides a method for using a focused ultrasound tissue fragmentation system, which includes the following steps:
[0091] Step S001: Acquire the original image of the region of interest;
[0092] Step S002: Based on the original image, adjust the multi-degree-of-freedom movement device to bring the transceiver-integrated focused ultrasound probe to the target position; the imaging system scans the target position image, and after multiple reciprocating corrections based on the horizontal and rotational movements of the region of interest and the target position, the transceiver-integrated focused ultrasound probe is aligned with the region of interest; the original image of the acquired region of interest is registered and fused with the real-time image obtained by the imaging system to locate the treatment area, specifically:
[0093] Based on the region of interest image acquired by S001, the position and angle of the transceiver focused ultrasound probe 110 are adjusted by the control system 132 of the tissue fragmentation workstation 130 via the multi-degree-of-freedom motion device 120. The multi-degree-of-freedom motion device 120 includes a robotic arm that can move and rotate along the X, Y, and Z axes. This design allows the focused ultrasound probe to approach the treatment area from any angle, ensuring that the probe can be precisely aligned with the region of interest.
[0094] In this step, the control system 132 of the tissue fragmentation workstation 130 registers and matches the raw images acquired in S001 with the real-time acquired images. Image processing algorithms analyze the feature points and differences between the two sets of images to precisely locate the areas requiring cavitation processing. This process is displayed in real-time on the monitor of the tissue fragmentation workstation 130, and doctors can make necessary adjustments and confirmations through the control components.
[0095] Step S004: Set the pulse transmission parameters of the transceiver focused ultrasound probe, including pulse transmission energy, transmission depth, frequency, and number of transducer units.
[0096] When cavitation is required, the control system 132 of the tissue fragmentation workstation 130 precisely controls the transceiver focused ultrasound probe 110 to emit pulse waves of a specific wavelength through a multi-channel signal generator, a multi-channel power amplifier 312, a multi-channel impedance matching network, and a multi-channel delay controller. The system controls the probe to emit high-energy short pulses, forming a cavitation bubble cloud in the target area.
[0097] During ultrasound emission, the system can monitor temperature changes and cavitation effects in the treatment area in real time, and dynamically adjust the parameters of the drive signal based on feedback information to ensure both treatment effectiveness and safety. The design of the multi-channel transducer 112 enables the system to achieve complex focusing modes, precisely control the energy distribution in the target area, and avoid damage to surrounding healthy tissues.
[0098] In another preferred embodiment, the system can automatically adjust pulse parameters according to different tissue types, such as compensating for the acoustic attenuation coefficient of adipose tissue and muscle tissue, thereby achieving personalized and precise treatment.
[0099] Example 3:
[0100] This embodiment provides a computer storage medium storing a computer program, which, when executed by a processor, implements the method of using the focused ultrasound tissue fragmentation system described in Embodiment 2.
[0101] The computer storage medium can be any medium capable of storing computer programs, such as read-only memory (ROM), random access memory (RAM), optical disc, hard disk, or USB flash drive. When the computer program is executed by the processor, it will perform the actions described in Embodiment 2: acquiring the original image of the region of interest, adjusting the multi-degree-of-freedom moving device to align the transceiver-integrated focused ultrasound probe 110 with the region of interest, matching the original image with the real-time image to locate the cavitation region, and controlling the focused ultrasound probe to emit pulses to generate cavitation bubble clouds in the cavitation region.
[0102] In a preferred embodiment, the computer program further includes an image processing module for preprocessing the acquired raw and real-time images to improve image quality and matching accuracy.
[0103] In another preferred embodiment, the computer program further includes a parameter adaptive adjustment module that can automatically adjust pulse parameters according to the tissue characteristics of different patients to achieve a personalized treatment plan.
[0104] In another preferred embodiment, the computer program further includes a treatment effect evaluation module, which can automatically evaluate the treatment effect by analyzing the differences in images before and after treatment, and provide decision support for doctors.
[0105] The computer program stored on the computer storage medium, in conjunction with the hardware of the focused ultrasound tissue fragmentation system 100, enables high-precision and high-safety pulsed cavitation therapy, such as tumor elimination.
[0106] Those skilled in the art will recognize that various aspects of this invention can be implemented as a system, method, or computer program product. Therefore, various aspects of this invention can be specifically implemented in the following forms: a completely hardware implementation, a completely software implementation (including firmware, resident software, microcode, etc.), or a combination of hardware and software aspects, collectively referred to herein as a "circuit," "module," or "system." Furthermore, in some embodiments, various aspects of this invention can also be implemented as a computer program product in one or more computer-readable media containing computer-readable program code. The implementation of the methods and / or systems of embodiments of this invention can involve performing or completing selected tasks manually, automatically, or in a combination thereof.
[0107] For example, the hardware for performing a selected task according to an embodiment of the present invention can be implemented as a chip or circuit. As software, the selected task according to an embodiment of the present invention can be implemented as a plurality of software instructions executed by a computer using any suitable operating system. In exemplary embodiments of the present invention, a data processor performs one or more tasks as described herein according to exemplary embodiments of the method and / or system, such as a computing platform for executing a plurality of instructions. Optionally, the data processor includes volatile storage for storing instructions and / or data and / or non-volatile storage for storing instructions and / or data, such as a magnetic hard disk and / or removable media. Optionally, a network connection is also provided. Optionally, a display and / or user input device, such as a keyboard or mouse, is also provided.
[0108] One or more computer-readable combinations may be used. A computer-readable medium can be a computer-readable signal medium or a computer-readable storage medium. A computer-readable storage medium can be, for example—but not limited to—an electrical, magnetic, optical, electromagnetic, infrared, or semiconductor system, apparatus, or device, or any combination thereof. More specific examples (a non-exhaustive list) of computer-readable storage media will include the following:
[0109] An electrical connection having one or more wires, a portable computer disk, a hard disk, random access memory (RAM), read-only memory (ROM), erasable programmable read-only memory (EPROM or flash memory), optical fiber, portable compact disc read-only memory (CD-ROM), optical storage device, magnetic storage device, or any suitable combination thereof. In this document, a computer-readable storage medium can be any tangible medium containing or storing a program that can be used by or in conjunction with an instruction execution system, apparatus, or device.
[0110] Computer-readable signal media may include data signals propagated in baseband or as part of a carrier wave, carrying computer-readable program code. Such propagated data signals may take various forms, including but not limited to electromagnetic signals, optical signals, or any suitable combination thereof. Computer-readable signal media may also be any computer-readable medium other than computer-readable storage media, capable of sending, propagating, or transmitting programs for use by or in connection with an instruction execution system, apparatus, or device.
[0111] Program code contained on a computer-readable medium may be transmitted using any suitable medium, including (but not limited to) wireless, wired, optical fiber, RF, etc., or any suitable combination thereof.
[0112] For example, computer program code for performing operations for various aspects of this invention can be written using any combination of one or more programming languages, including object-oriented programming languages such as Java, Smalltalk, and C++, and conventional procedural programming languages such as the "C" programming language or similar programming languages. The program code can be executed entirely on the user's computer, partially on the user's computer, as a standalone software package, partially on the user's computer and partially on a remote computer, or entirely on a remote computer or server. In cases involving remote computers, the remote computer can be connected to the user's computer via any type of network—including a local area network (LAN) or a wide area network (WAN)—or can be connected to an external computer (e.g., via the Internet using an Internet service provider).
[0113] It should be understood that each block of a flowchart and / or block diagram, as well as combinations of blocks in a flowchart and / or block diagram, can be implemented by computer program instructions. These computer program instructions can be provided to a processor of a general-purpose computer, a special-purpose computer, or other programmable data processing apparatus to produce a machine such that, when executed by the processor of the computer or other programmable data processing apparatus, these computer program instructions create means for implementing the functions / actions specified in one or more blocks of the flowchart and / or block diagram.
[0114] These computer program instructions may also be stored in a computer-readable medium, which causes a computer, other programmable data processing apparatus, or other device to operate in a particular manner, thereby producing an article of manufacture that includes instructions for implementing the functions / actions specified in one or more boxes of a flowchart and / or block diagram.
[0115] Computer program instructions may also be loaded onto a computer (e.g., a coronary artery analysis system) or other programmable data processing apparatus to cause a series of operational steps to be performed on the computer, other programmable data processing apparatus or other apparatus to produce a computer-implemented process, such that the instructions that execute on the computer, other programmable apparatus or other apparatus provide a process for implementing the functions / actions specified in the flowchart and / or one or more block diagram boxes.
[0116] The above specific examples of this utility model have further described in detail the purpose, technical solution and beneficial effects of this utility model. It should be understood that the above are only specific embodiments of this utility model and are not intended to limit this utility model. Any modifications, equivalent substitutions, improvements, etc., made within the spirit and principles of this utility model should be included within the protection scope of this utility model.
Claims
1. A focused ultrasound tissue fragmentation system, characterized in that, include: Integrated transceiver focused ultrasound probe, multi-degree-of-freedom moving device, tissue fragmentation workstation; The tissue fragmentation workstation is used to adjust the position of the focused ultrasound probe according to the region of interest, receive images of the region of interest, process the images, and control the focused ultrasound probe to emit pulse waves. The multi-degree-of-freedom moving device is connected to the tissue fragmentation workstation and is used to adjust the position of the transceiver focused ultrasound probe. The integrated transceiver focused ultrasound probe is connected to the multi-degree-of-freedom moving device and the tissue fragmentation workstation, respectively, and is used to generate cavitation bubble clouds in the tissue fragmentation area, locate the cavitation area, and perform tissue fragmentation on the region of interest.
2. The focused ultrasound tissue fragmentation system according to claim 1, characterized in that, The transceiver integrated focused ultrasound probe is a high-intensity focused ultrasound multi-channel phased array probe, including a transducer base, a multi-channel transducer, an imaging device, and a filling layer; The transducer base includes a substrate, and a multi-channel transducer and an imaging system disposed inside the substrate. The multi-channel transducer is uniformly arranged on the substrate in a circular array along the center of the substrate. The multi-channel transducer includes multiple sets of transducer units, and the emitting end of the transducer unit is fan-shaped, rectangular, or trapezoidal. The imaging system is mounted on the substrate; The filling layer is filled between the substrate and the multi-channel transducer.
3. The focused ultrasound tissue fragmentation system according to claim 1, characterized in that, The multi-degree-of-freedom mobile device includes a robotic arm that can move and rotate along the X, Y, and Z axes.
4. The focused ultrasound tissue fragmentation system according to claim 2, characterized in that, The tissue fragmentation workstation includes: a main body, a control system, and an electronic drive system, wherein the control system and the electronic drive system are disposed within the main body; The control system is connected to the electronic drive system, the transceiver focused ultrasound probe, and the imaging system. The electronic drive system is connected to the transceiver focused ultrasound probe and the multi-degree-of-freedom moving device, and is used to drive the transceiver focused ultrasound probe to emit pulse waves and control and drive the multi-degree-of-freedom moving device to move. The control system is used to control the imaging system to scan the image of the region of interest and to receive information from the transceiver focused ultrasound probe and the imaging system.
5. A focused ultrasound tissue fragmentation system according to claim 4, characterized in that, The tissue fragmentation workstation also includes a display and a control component, both of which are connected to the control system.
6. A focused ultrasound tissue fragmentation system according to claim 4, characterized in that, The electronic drive system includes: a data acquisition device, a control device, a phase synchronization management device, a power amplifier integration device, and a pulse voltage adjustment device, all mounted on an integrated circuit board. The data acquisition device is used to acquire medical image data and pulse emission feedback data sent by the image acquisition device; The control device is connected to the data acquisition device, pulse voltage adjustment device, and phase synchronization management device, and is used to set the following parameters, including tissue fragmentation space reconstruction, transmission frequency, digital isolation, heat dissipation, digital-to-analog conversion, voltage detection, current detection, temperature detection, and phase management. The pulse voltage regulating device is used to emit pulse waves according to the command of the control device; The power amplifier integration module is connected to the pulse voltage adjustment device and is used to complete the integration of 8 to 128 power amplifiers, receive synchronous trigger information, and output a start transmission pulse signal to the multi-angle focused ultrasound therapy system. The phase synchronization management module is responsible for the communication interface with the user terminal and the transmission of phase information. It also performs the synchronization function of the multi-channel integrated module, and the phase of each channel is individually adjustable.
7. A focused ultrasound tissue fragmentation system according to claim 6, characterized in that, The phase synchronization management module includes a microprocessor, a phase distribution module, a power management module, a power status detection module, and an upstream and downstream device communication module. The microprocessor is connected to the upstream and downstream device communication module, the power status detection module, and the phase distribution module. The power management module is mounted on the integrated circuit board.
8. A focused ultrasound tissue fragmentation system according to claim 4, characterized in that, The substrate includes a connecting rod and a scanning head. The connecting rod is connected to the multi-degree-of-freedom moving device. The bottom of the scanning head is a bare structure. Multiple mounting mechanisms are uniformly arranged in an array inside the scanning head. The multi-channel transducer is disposed in the mounting mechanism.
9. A focused ultrasound tissue fragmentation system according to claim 8, characterized in that, The imaging system includes: an image acquisition unit, a clamp, and a linear rotary motion mechanism connected in sequence. The image acquisition unit passes through the center of the scanning head, and an elastic sealing structure is provided between the scanning head and the image acquisition unit. The linear rotary motion mechanism is connected to the electronic drive system.
10. A focused ultrasound tissue fragmentation system according to claim 2, characterized in that, The multi-channel transducer comprises 64 to 1024 transducer units, wherein the number of transducer units is an even number.
11. A focused ultrasound tissue fragmentation system according to claim 10, characterized in that, The transducer unit includes: a housing, a piezoelectric ceramic substrate, a backing layer, a signal transmission unit, and a multilayer acoustic impedance matching layer. The housing is connected to the mounting structure. An opening is provided at the bottom of the housing. The piezoelectric ceramic substrate is disposed in the middle of the housing. The multilayer acoustic impedance matching layer is disposed on the surface of the piezoelectric ceramic substrate facing the opening. The backing layer is disposed on the surface of the piezoelectric ceramic substrate facing away from the opening. The piezoelectric ceramic substrate is used to transmit pulses after being connected to the signal transmission unit.
12. A focused ultrasound tissue fragmentation system according to claim 4, characterized in that, The control system includes a multi-channel signal generator, a multi-channel power amplifier, a multi-channel impedance matching network, a multi-channel delay controller, and a central processing unit. The central processing unit and the tuning circuit are connected to the multi-channel signal generator, the multi-channel power amplifier, the multi-channel impedance matching network, and the multi-channel delay controller, and are used to control the ultrasonic frequency, amplitude, phase, pulse time, and pulse repetition frequency emitted by the transducer unit.