An ultrahigh strength self-focusing ultrasound treatment system and method of use

Abstract

The application relates to the medical field and discloses an ultrahigh-strength self-focusing ultrasonic treatment system and a use method, which comprise a patient bearing device, a treatment head system, a TPS software control system and a high-frequency power source device, the patient bearing device moves a patient to under the treatment head system, a multi-axis driving unit of the treatment head system drives a B-ultrasonic head to acquire real-time images of a lesion, the TPS software control system adjusts the position of the patient bearing device according to the real-time images, so that the lesion is in a focusing range of a self-focusing ultrasonic transducer, the TPS software control system also automatically delineates a lesion boundary, selects a treatment mode and generates a dose parameter, the high-frequency power source device emits energy according to the parameter, and the treatment head system moves the focal point of the transducer in a synchronous linkage mode; the application also provides a system use method, which uses a multi-focal-length transducer, a multi-axis driving unit and microsecond-level energy regulation and control, improves tissue inactivation efficiency and thoroughness, guarantees treatment path safety, provides guarantee for noninvasive / minimally invasive treatment of various solid malignant tumors and solves the problems of precision and safety in a complex treatment environment.

Description

Technical Field

[0001] This invention relates to the medical field, specifically to an ultra-high intensity self-focusing ultrasound therapy system and its usage. Background Technology

[0002] Currently, there are two main technical approaches to non-invasive treatment devices for solid tumors such as uterine fibroids and liver cancer, both of which have significant limitations. Furthermore, there are still gaps in key technologies within the industry. Firstly, most existing ultrasound therapy equipment in China uses high-intensity focused ultrasound (HIFU) technology, equipped with acoustic lenses, multi-element arrays, or phased array transducers. Treatment power ranges from tens to hundreds of watts. It uses focused ultrasound to raise the temperature of target tissue to 65℃-100℃, causing coagulative necrosis. This can treat simple lesions such as uterine fibroids and liver cancer without rib shielding. However, due to significant attenuation of ultrasound waves within the body (e.g., the liver attenuation rate is approximately 0.7 dB / cm / MHz), energy deposition in deep lesions is insufficient. Increasing the power can lead to a 3%–8% skin burn rate and thermal damage to the acoustic channel tissue. Furthermore, it cannot treat liver cancer with rib shielding, and the treatment effectiveness is only 70%–80%. It also lacks dynamic target tracking capabilities. In contrast, only HistoSonics is available internationally. The company's Edison device uses the pure cavitation effect (Histotripsy), which uses a phased array transducer to cause tissue liquefaction and ablation through bubble generation, expansion and collapse. It can treat liver cancer and uterine fibroids, but the treatment mode is singular and it is difficult to adapt to complex lesions such as liver cancer and kidney cancer that are obscured by ribs. In addition, the treatment time is long and the clinical efficiency is low. Furthermore, there is currently no pure cavitation treatment equipment in China. There is no multi-mode ultrasound treatment system that can integrate thermal effect, cavitation effect and thermal superimposed cavitation effect, either domestically or internationally. Therefore, existing technologies cannot solve clinical pain points such as acoustic channel tissue obstruction, insufficient energy in deep target areas, and poor adaptability to complex lesions, making it difficult to meet the needs of efficient, safe, and non-invasive treatment of various types of solid lesions. Summary of the Invention

[0003] The purpose of this invention is to provide an ultra-high intensity self-focusing ultrasound therapy system and its usage method. By incorporating a multi-focal length self-focusing ultrasound transducer, a multi-axis drive unit, and a high-frequency power source into the treatment head system, the system achieves microsecond-level dynamic control of ultrasound energy. This significantly improves tissue inactivation efficiency, shortens treatment time, and enhances the thoroughness of lesion tissue inactivation. Energy release is strictly confined to the focal area, preventing tissue heating along the sound wave propagation path and maintaining treatment path safety. This provides a guarantee for one-time non-invasive or minimally invasive treatment of various solid malignant tumors such as liver cancer, kidney cancer, and pancreatic cancer. It also offers a novel solution to address the challenges of precision, efficiency, safety, and non-invasiveness in complex treatment environments, such as those involving tissue obstruction in the acoustic channel and deep target areas.

[0004] This invention is achieved through the following technical solution: A high-intensity self-focusing ultrasound therapy system, comprising: The patient support device is located below the ultrasound coupling device and moves the patient below the treatment head system; The treatment head system includes an ultrasound treatment head and a multi-axis drive unit. The multi-axis drive unit moves the B-ultrasound head inside the ultrasound treatment head to the epidermis above the patient's lesion to acquire real-time B-ultrasound images of the target lesion. The TPS software control system adjusts the position of the patient support device according to the acquired B-ultrasound image information, so that the focusing range of the self-focusing ultrasound transducer in the treatment head system can cover the lesion; and the TPS software control system also automatically delineates the lesion boundary and ultrasound treatment channel according to the B-ultrasound image information, generates treatment points, and automatically selects the thermal effect, cavitation effect or thermal superimposed cavitation effect treatment mode, and generates corresponding treatment dose parameters. The high-frequency power source device adjusts the focused ultrasound energy of the self-focusing ultrasound transducer according to the selected treatment mode and the generated treatment dose parameters, and causes the treatment head system to synchronously adjust the multi-axis drive unit to move the transducer focus to each treatment point according to the set treatment step distance.

[0005] In this solution, the multi-axis drive unit of the treatment head system drives the ultrasound head to accurately acquire real-time images of the lesion. Combined with the TPS software control system's adjustment of the patient support device's position, it ensures that the lesion accurately falls within the focusing range of the self-focusing ultrasound transducer, effectively solving the problem of incomplete treatment or accidental damage to normal tissue caused by lesion positioning deviations in traditional treatments. Furthermore, the TPS software control system automatically delineates the lesion boundary and plans the treatment channel based on the ultrasound images, and autonomously selects the thermal effect, cavitation effect, or thermal superimposed cavitation effect treatment mode and corresponding dosage parameters according to the lesion characteristics, eliminating the need for manual experience judgment and avoiding human operation errors. Simultaneously, the high-frequency power source device operates according to the selected mode. By transmitting focused ultrasound energy with parameters and simultaneously coordinating with the treatment head system to adjust the multi-axis drive unit to move the transducer focus at a set step distance, energy can be efficiently and concentratedly released in the lesion area. This significantly improves tissue inactivation efficiency and shortens treatment time, ensuring thorough inactivation of lesion tissue. Furthermore, the energy release is strictly limited to the focal area, preventing tissue heating along the sound wave propagation path and maintaining the safety of the treatment path. This provides a reliable guarantee for one-time non-invasive or minimally invasive treatment of various solid malignant tumors such as liver cancer, kidney cancer, and pancreatic cancer. It also provides a new solution for solving the problems of precision, efficiency, safety, and non-invasiveness in complex treatment environments such as human tissue obstruction in the acoustic channel and deep target areas.

[0006] In a further embodiment, the self-focusing ultrasound transducer includes short-focal-length and long-focal-length transducers adapted to lesions of different depths. The ultrasound head, the short-focal-length transducer, and the long-focal-length transducer are switched by rotation via a servo motor to simultaneously complete lesion monitoring and energy focusing. This embodiment, through the targeted adaptation of the short-focal-length and long-focal-length transducers, can match the energy focusing requirements of superficial and deep lesions, effectively solving the problem that traditional single-focal-length transducers cannot simultaneously handle lesions of different depths, and are prone to energy excess in superficial lesions or insufficient energy in deep lesions. This ensures that lesions of all depths can receive sufficient and appropriate treatment energy. At the same time, the servo motor enables the rotational switching between the ultrasound head and the two transducers, allowing for rapid synchronization of real-time lesion monitoring and energy focusing without additional disassembly or adjustment of components during treatment. This avoids treatment interruptions and time losses caused by frequent equipment changes or component adjustments, improving treatment efficiency, and ensures that the transducer focus is always aligned with the lesion through real-time monitoring by the ultrasound head.

[0007] In a further embodiment, a water treatment device is also included. The water treatment device uses a PLC as the control core to generate degassed water and deliver it to the ultrasonic treatment head and the ultrasonic coupling device. This ensures that the ultrasonic energy is efficiently and stably transmitted to the lesion, while providing a good working environment for the transducer and eliminating coupling gaps.

[0008] In a further embodiment, the ultrasound coupling device is a movable water tank. The adjustable movable legs installed on the patient support device are adjusted longitudinally to ensure that the bottom of the water tank fits tightly against the skin of the patient's treatment site, effectively eliminating the air gap between them and avoiding the reflection and obstruction of ultrasound energy by air. Furthermore, the bottom of the water tank is attached with an acoustic membrane, which can further reduce the loss of ultrasound energy during transmission and ensure that the focused ultrasound energy emitted by the high-frequency power source device is efficient and stable.

[0009] In a further embodiment, a control device is also included. This control device is electrically connected to the treatment head system, the high-frequency power source device, the water treatment device, the ultrasound coupling device, the patient support device, and the TPS software control system. The control device can quickly trigger a coordinated response across the entire system, further ensuring the safety and stability of the treatment.

[0010] A method of using an ultra-high intensity self-focusing ultrasound therapy system, comprising an ultra-high intensity self-focusing ultrasound therapy system, including the following steps: Step 1: The treatment medium is processed by a water treatment device and then delivered to the treatment head system and the ultrasonic coupling device; Step 2: Obtain the initial ultrasound image of the target lesion through the built-in ultrasound probe of the treatment head system, and adjust the position of the patient support device and the ultrasound treatment head to move the lesion into the focusing range of the self-focusing ultrasound transducer in the treatment head system. Step 3: The TPS software control system selects the treatment step distance and performs a pre-scan based on the ultrasound image information. The lesion and ultrasound treatment channel are drawn on the lesion image to generate treatment points and the lesion boundary is delineated. Then, the thermal effect, cavitation effect or thermal superimposed cavitation effect treatment mode is automatically selected based on the lesion information, and the corresponding treatment dose parameters are generated. Step 4: The high-frequency power source device adjusts the focused ultrasound energy of the self-focusing ultrasound transducer according to the generated treatment dose parameters; the TPS software control system synchronously adjusts the multi-axis drive unit of the treatment head system, moves the focus of the self-focusing ultrasound transducer to each treatment point according to the set treatment step distance, and monitors the lesion status in real time through B-ultrasound, which can ensure that the energy evenly covers each treatment point of the lesion, greatly improving the efficiency and thoroughness of tissue inactivation. Step 5: During or after treatment, compare the real-time images acquired by monitoring with the preset initial images of the lesions. Based on the comparison results, select to continue treatment, adjust treatment parameters and then continue treatment, or end treatment, and generate a treatment result report.

[0011] In step 3, the TPS software control system automatically draws lines on the lesion image and ultrasound treatment channel to generate treatment points, outlines the epidermal position line of the patient's lesion, and draws multiple treatment horizontal lines on the lesion. The distance between the highest horizontal line and the lowest horizontal line is the treatment boundary in the height direction of the lesion. This step automatically draws lines through software to clearly define the location of the lesion on the epidermis and the treatment boundary in the high direction. This transforms the abstract three-dimensional spatial range of the lesion into an intuitive and precise visual marker, effectively avoiding the problem of inaccurate treatment range definition caused by subjective judgment or operational errors when manually drawing boundaries. At the same time, clear treatment channel lines can pre-plan the ultrasound energy transmission path, avoiding sensitive tissues or obstructing structures in the acoustic channel and reducing the potential impact of energy on normal tissues. The clear high-direction treatment boundary and treatment point of the lesion provide a precise spatial basis for setting the treatment step distance and allocating treatment energy, ensuring that the focus of the self-focusing ultrasound transducer can completely cover the lesion area according to the preset boundary. This avoids missed treatment of lesions or overtreatment of normal tissues due to blurred boundaries, and allows the generation of treatment dosage parameters to be more in line with the actual size and shape of the lesion, further improving the accuracy and safety of treatment.

[0012] During the pre-scan, the TPS software control system automatically generates a 3D treatment image based on the position of each treatment line. Each treatment line represents a layer of ultrasound image. After confirming the lesion on each layer, a static image is automatically generated and saved. This step, by corresponding the treatment lines with the ultrasound image layers and generating a 3D treatment image, transforms the 2D image information of the lesion into an intuitive 3D spatial model, providing a clearer understanding of the lesion's three-dimensional shape, size, and spatial distribution. This avoids misjudgments of lesion information caused by the limitations of 2D images. Simultaneously, automatically saving the static image after confirming each lesion layer provides a precise benchmark for real-time comparison of lesion positions during subsequent treatment, facilitating timely detection and rapid adjustment of potential lesion displacement during treatment. It also completely preserves the original image data of each lesion layer before treatment, providing reliable image evidence for post-treatment efficacy evaluation (such as comparing morphological changes before and after lesion ablation) and clinical review, effectively reducing treatment deviations caused by missing image information or inaccurate references.

[0013] The treatment step distance can be manually set within the range of 0.5mm to 10mm. The TPS software control system generates real-time two-dimensional images based on the ultrasound layer corresponding to each step distance, which are used to compare the lesion location and ablation status with the initial image. The real-time two-dimensional images generated for each step distance in this step can be accurately compared with the initial image. This not only allows for real-time monitoring of whether the lesion has shifted due to the patient's breathing, body position changes, etc., so as to make timely adjustments to ensure that the treatment focus is always aligned with the lesion, but also allows for intuitive observation of the ablation status of the lesion after each treatment step (such as grayscale changes, morphological changes), helping medical staff to dynamically grasp the treatment progress and avoid undertreatment or overtreatment due to the inability to judge the ablation effect in real time.

[0014] In step 5, when the grayscale difference between the real-time image and the initial image is greater than or equal to a preset threshold, the corresponding area is determined to be an effective ablation area. If the effective ablation area does not cover the lesion treatment area, the treatment parameters are adjusted and the process returns to step S3 to continue treatment. This step forms a closed-loop control mechanism of "judgment-feedback-adjustment", which can dynamically adapt to possible changes in the lesion during the treatment process (such as changes in lesion morphology caused by energy action), so that the treatment plan always fits the actual treatment needs of the lesion, further improving the thoroughness and reliability of the treatment.

[0015] Compared with the prior art, the present invention has the following advantages and beneficial effects: 1. This invention uses a multi-axis drive unit of the treatment head system to drive the ultrasound head to acquire real-time images. Combined with the TPS software control system, it adjusts the position of the patient support device and the treatment head to ensure that the lesion falls precisely into the focusing range of the self-focusing ultrasound transducer. The treatment step distance can be flexibly set from 0.5mm to 10mm. Each step distance generates a real-time two-dimensional image and compares it with the initial image, effectively avoiding human positioning errors and energy focusing deviations, and achieving precise coverage of the lesion. 2. This invention adapts to lesions of different depths by using short and long focal length transducers, and with the design of a movable water tank and sound-permeable membrane, it can adapt to patients of different body types and lesions in multiple locations such as the abdomen and pelvis. At the same time, the degassed water generated by the water treatment device ensures efficient energy transmission in different treatment scenarios, greatly expanding the scope of clinical application. 3. The TPS software control system of the present invention can automatically delineate the lesion boundary, plan the treatment channel, autonomously select treatment modes such as thermal effect and cavitation effect according to the lesion information and generate dose parameters. During the pre-scan, it automatically generates a three-dimensional treatment image and a static image. During the treatment, it monitors the lesion status in real time. After the treatment, it uses grayscale difference to quantify and determine the ablation effect, reducing manual intervention while improving the operation efficiency and the scientific nature of the plan. 4. This invention achieves microsecond-level dynamic energy control through a high-frequency power source device, ensuring that the energy is strictly limited to the focal area, avoiding tissue heating in the acoustic channel, and the closed-loop mechanism of "judgment-feedback-adjustment" can ensure that the lesion is fully inactivated. It not only solves the treatment problems in complex treatment environments (such as tissue obstruction and deep target areas) in the prior art, but also provides a reliable guarantee for one-time non-invasive / minimally invasive treatment of solid tumors such as liver cancer and kidney cancer, significantly improving the treatment effect and patient safety. Attached Figure Description

[0016] The accompanying drawings, which are included to provide a further understanding of embodiments of the invention and form part of this application, do not constitute a limitation thereof. In the drawings: Figure 1 This is a schematic diagram of the structure of the present invention; Figure 2 This is a schematic diagram of the composition and structure of the treatment head system in this invention; Figure 3 This is a schematic diagram of the composition and structure of the water treatment device in this invention; Figure 4 This is a schematic diagram of the composition of the patient support device in this invention; Figure 5 This is a schematic diagram of the composition of the control device in this invention; Figure 6 This is a schematic diagram of the usage process of the present invention; Figure 7 This is a schematic diagram of the pre-scan process performed by the TPS software control system in this invention. Figure 8 A schematic diagram of the ultrasound image layers generated for each treatment line; Figures 9-11 This is a 3D treatment image automatically generated based on the position of each treatment line. Figure 12 A comparison table of energy and parameters for thermal effects, cavitation effects, and thermal superposition cavitation effects; Figure 13 This is an anatomical diagram after treatment using the present invention.

[0017] The attached diagram shows the markings and corresponding component names: 1-Treatment head system, 1.1-Ultrasonic treatment head, 2-Power distribution device, 3-High frequency power source device, 4-Water treatment device, 5-Ultrasonic coupling device, 6-Patient carrier device, 7-Control device, 8-TPS software control system. Detailed Implementation

[0018] To make the objectives, technical solutions, and advantages of the present invention clearer, the present invention will be further described in detail below with reference to the embodiments and accompanying drawings. The illustrative embodiments and descriptions of the present invention are only used to explain the present invention and are not intended to limit the present invention. Example

[0019] This embodiment provides an ultra-high intensity self-focusing ultrasound therapy system, such as Figure 1 As shown, the system includes a treatment head system 1, a power distribution device 2, a high-frequency power source device 3, a water treatment device 4, an ultrasonic coupling device 5, a patient support device 6, a control device 7, and a TPS software control system 8. Each device is connected to a signal line via circuits to form a unified and controlled treatment system.

[0020] Specifically, such as Figure 1 and Figure 2As shown, the treatment head system 1 integrates an auxiliary power supply module, a multi-axis drive unit, and an ultrasound treatment head 1.1. The auxiliary power supply module includes a filter, a servo-specific transformer, and a 24V switching power supply (model DR-120-24). The filter is used to filter out electromagnetic interference from the external power grid and ensure stable internal circuit signals. The servo-specific transformer provides the appropriate voltage for the multi-axis drive unit, and the 24V switching power supply powers low-voltage components such as the encoder and positioning control module, ensuring stable power supply to each component. The multi-axis drive unit consists of X1, Y1, and Z1 axis servo drivers, an encoder, a stepper motor, and a grating ruler. The servo drivers receive commands from the control device 7 and drive the stepper motors to move the ultrasound treatment head 1.1 along the X1 (left-right), Y1 (back-forward), and Z1 (up-down) axes. The encoder collects the motor rotation angle in real time, and the grating ruler assists in detecting displacement. The two form a closed-loop feedback to ensure that the transducer focus is accurately positioned to the lesion. At the same time, this unit is also equipped with a pulse output module to control the rotation of the DD servo motor and realize the switching between the ultrasound head and the transducer in the ultrasound treatment head 1.1.

[0021] In this embodiment, the ultrasound head is installed inside the ultrasound treatment head 1.1 and can be moved above the lesion epidermis under the drive of the multi-axis drive unit to acquire real-time ultrasound images. This provides the TPS software control system 8 with basic data such as the location, shape, and boundary of the lesion, and supports real-time monitoring of the lesion ablation status during treatment. The transducers include a short focal length transducer (focal length 5-10cm, suitable for superficial lesions, such as uterine fibroids) and a long focal length transducer (focal length 10-18cm, suitable for deep lesions, such as deep liver cancer). The two transducers and the ultrasound head are switched at 90° through a DD servo motor, which can simultaneously complete real-time lesion monitoring (ultrasound head) and energy focusing (transducer), avoiding treatment interruption.

[0022] Specifically, the power distribution unit 2 provides power to the treatment head system 1, high-frequency power source unit 3, water treatment unit 4, ultrasonic coupling unit 5, patient support unit 6, control unit 7, and TPS software control system 8, enabling on / off control of the circuits, overload and short-circuit protection, and electromagnetic interference filtering. It also includes core control and drive components such as a PLC (Programmable Logic Controller), PLC input expansion module, servo transformer, and servo driver, specifically designed for precise motion control of the treatment head system 1 and patient support unit 6. Furthermore, the unit has independent control switches for power, electricity, and water treatment, allowing for individual start / stop operations of each corresponding control module. It is also equipped with warning lights for power status, fan operation, multi-level power, and water treatment system functions, which can be triggered in real time to alert operators to troubleshoot malfunctions.

[0023] Specifically, the output of the radio frequency generator of the high-frequency power source device 3 is connected to the dual-focal length self-focusing ultrasound transducer of the treatment head system 1 through a radio frequency cable (SMA connector) to transmit ultrasound energy of 100W to 6000W. The output is also connected in series with a power sensor and connected to the control device 7 through a signal line to provide real-time feedback on the output power.

[0024] Specifically, such as Figure 1 and Figure 3 As shown, the deaerated water output end of the water treatment device 4 is divided into two paths through a PU hose. One path is connected to the inlet of the ultrasonic treatment head 1.1 of the treatment head system 1, and the other path is connected to the water tank inlet of the ultrasonic coupling device 5. The outlet of the ultrasonic treatment head 1.1 of the treatment head system 1 and the water tank outlet of the ultrasonic coupling device 5 are connected to the return end of the water treatment device 4 through the PU hose to form a closed-loop water circulation. The outlet of the drain pump is connected to an external drain pipe through a PU hose for discharging residual water from the system after treatment.

[0025] In this embodiment, the ultrasonic coupling device 5 is a movable stainless steel water tank with a sound-permeable membrane such as PU polyurethane film, PE polyethylene film, PVC polyvinyl chloride film, fluororubber film, or silicone attached to the bottom. It is equipped with four adjustable movable legs. The side wall of the water tank is equipped with an inlet, an outlet, and a water level sensor. The input end of the servo motor of the movable leg of the ultrasonic coupling device 5 is connected to the output end of the servo transformer of the power distribution device 2 through a single-phase cable to obtain the driving power. The water inlet of the ultrasonic coupling device 5 is connected to the deaerated water output end of the water treatment device 4 through a PU hose, and the outlet is connected to the return end of the water treatment device 4 through a PU hose to realize the filling and circulation of deaerated water and eliminate the energy reflection loss of air gaps.

[0026] Specifically, such as Figure 1 and Figure 4 As shown, the patient support device 6 integrates a multi-axis drive unit with X2 / Y2 / Z2 axes. The multi-axis drive unit with X2 / Y2 / Z2 axes is connected to the control device 7 via an RS485 bus to receive displacement commands. The three axes are also equipped with positioning control modules and grating rulers, which can realize large-stroke displacement control and ensure that the patient's lesion can be accurately moved to the designated position. This not only provides convenience for patients to get on and off the bed, but also creates stable conditions for medical staff to check the treatment effect.

[0027] Specifically, such as Figure 1 and Figure 5As shown, the control device 7 is connected via a bus to the control signal ports of the treatment head system 1, power distribution device 2, high-frequency power source device 3, water treatment device 4, ultrasound coupling device 5, and patient carrier device 6, respectively, to realize command issuance and data acquisition. The ultrasound keyboard is connected to the ultrasound host via a USB interface for adjusting ultrasound image parameters. The ultrasound monitor is connected to the PC via an HDMI video capture card to display real-time ultrasound images and treatment data. Furthermore, the PC of the control device 7 has a built-in TPS software control system 8, which stores treatment parameters and image data in a database and communicates with each hardware module through an API interface to achieve full-process control of "parameter setting - command issuance - status feedback - efficacy evaluation".

[0028] Specifically, the TPS software control system 8 connects to the X1 / Y1 / Z1 axis servo drives of the treatment head system 1 and the X2 / Y2 / Z2 axis servo drives of the patient support device 6 via a bus, sends displacement parameters (distance, speed, accuracy), receives feedback displacement data, and forms a closed-loop control; it also calls the disease treatment knowledge base (such as uterine fibroids, liver cancer, liver cancer with rib obstruction, kidney cancer, etc.) through the database, and automatically generates treatment modes (thermal effect / cavitation effect / thermal superimposed cavitation effect), treatment channels and dosage parameters based on the lesion parameters (size, depth, obstruction) input by the user, and displays them through the UI interface and sends them to the corresponding hardware modules.

[0029] The usage method of this ultrasound therapy system is as follows: Figure 6 As shown, it includes the following steps: Step 1: The treatment medium is processed by the water treatment device 4 and delivered to the treatment head system 1 and the ultrasonic coupling device 5; Specifically, in the TPS software control system 8 UI interface of the control device 7, the "Water Treatment Control" module is entered, the deaerated water parameters are set, the PLC of the water treatment device 4 receives the instruction, drives the water inlet pump to start, and tap water enters the deaeration tank; at the same time, the vacuum pump starts to extract the air in the tank, thereby realizing the deaeration treatment of the water.

[0030] When the dissolved oxygen level reaches the set threshold, the PLC of the water treatment device 4 automatically opens the "head water valve" and the "bed water valve". The degassed water is delivered in two paths through the PU hose: one path enters the interior through the inlet of the ultrasonic treatment head 1.1 of the treatment head system 1 to cool the self-focusing ultrasonic transducer (to prevent the transducer from overheating and being damaged or its performance reduced), and then flows back from the outlet to the return end of the water treatment device 4; the other path is injected through the water tank inlet of the ultrasonic coupling device 5 until the water tank level reaches 80% (as fed back by the water tank level sensor), at which point the PLC closes the "bed water valve" and stops the water supply.

[0031] Step 2: Obtain the initial ultrasound image of the target lesion through the built-in ultrasound probe of the treatment head system 1, and adjust the position of the patient support device 6 and the ultrasound treatment head 1.1 so that the focusing range of the self-focusing ultrasound transducer in the treatment head system 1 can cover the lesion. Specifically, the patient lies on the bed surface of the patient support device 6, and the medical staff uses the handheld controller of the patient support device 6 to operate the X2 axis (left and right) and Y2 axis (back and forth) to move the marked epidermal treatment area directly below the water tank of the ultrasound coupling device 5; then adjust the Z2 axis (lifting) to make the sound-permeable membrane at the bottom of the water tank fit with the patient's epidermis.

[0032] In the TPS software control system 8 UI interface, enter the "Treatment Head Control" module, click "B-ultrasound head switching", and the control device 7 sends a command to the pulse output module of the treatment head system 1 to drive the DD servo motor to rotate 90° and move the B-ultrasound head directly below the ultrasound treatment head 1.1; then adjust the X1 axis (left and right), Y1 axis (front and back), and Z1 axis (up and down) of the treatment head system 1 so that the B-ultrasound head fits the patient's epidermal marking area, and acquires the initial B-ultrasound image of the target lesion. The image is automatically stored in the MySQL database.

[0033] The TPS software control system 8 automatically identifies the lesion boundary in the initial image and extracts the lesion boundary coordinates (it only requires the lesion boundary to be within the range of movement of the three axes X1, Y1, and Z1). Based on the lesion depth, it automatically selects either a long focal length self-focusing ultrasound transducer or a short focal length self-focusing ultrasound transducer.

[0034] Step 3: The TPS software control system 8 selects the treatment step distance and performs a pre-scan based on the ultrasound image information. It draws lines on the lesion image and ultrasound treatment channel to delineate the lesion boundary. Then, it automatically selects the thermal effect, cavitation effect or thermal superimposed cavitation effect treatment mode based on the lesion information and generates the corresponding treatment dose parameters. Specifically, in the TPS software control system 8 UI interface, enter the "Treatment Planning" module. Based on the size and complexity of the lesion (with rib obstruction), select the treatment step distance, ranging from 0.5mm to 10mm. Click "Start Pre-scan." Because the small step distance ensures no energy coverage in the rib-obstructed area, the system drives the X1 axis of the treatment head system 1.1 to move according to the required step distance. The ultrasound head simultaneously acquires the ultrasound image layers corresponding to each step distance (e.g., each treatment line is one layer, up to 50 layers, corresponding to a lesion height of 5cm). Figure 8 As shown.

[0035] Then, the TPS software control system 8 automatically stitches together several ultrasound image layers acquired from the pre-scan to generate a three-dimensional treatment image, such as... Figures 9-11As shown, the position line of the epidermis above the lesion (skin pressure line) is drawn on the image. Based on the epidermal echo characteristics, the baseline for the contact between the sound-transmitting membrane and the epidermis is determined to avoid the position of the epidermis shifting during treatment. Several treatment horizontal lines are generated in the lesion area. Each horizontal line automatically generates a treatment point, and the length of each horizontal line is the treatment boundary in the width direction of the lesion. The distance between the highest horizontal line and the lowest horizontal line among the multiple horizontal lines is the treatment boundary in the height direction of the lesion. Furthermore, the energy output of the "thermal superposition cavitation effect" can be adjusted based on the area of ​​rib obstruction obtained from the image, and the temperature rise of the rib can be controlled by using a low-heat + mechanical damage method to achieve effective ablation.

[0036] The expert system module of the TPS software control system 8 automatically selects the treatment mode of thermal effect, cavitation effect, or thermal superimposed cavitation effect based on lesion information. In this embodiment, the treatment mode matched according to the lesion information is "thermal superimposed cavitation effect" (in this mode, thermal energy precisely raises the local temperature of the lesion tissue to 50-65℃, where 50-55℃ induces cell apoptosis and 55-65℃ induces coagulative necrosis of the tissue. Mechanical energy is released instantaneously at an extremely high energy density of 1600-2000 J / cm³ in the pyrokinetic nucleus, producing a significant cavitation effect, which is maintained for 0.1 seconds to 25 seconds. The energy coupling efficiency is strictly controlled at 20% to 50%, and the pulse time is extremely short, strictly controlling the energy actually entering the pyrokinetic nucleus and converting it into thermal energy, controlling the overall temperature rise to the tens of degrees. Most of the energy is released in the form of cavitation, bubble collapse shock waves, and local micro-bursts. The internal temperature of these local bubbles can instantly reach 5000K-10000K). Therefore, although the overall temperature rise of the char core is limited, it exhibits micronucleus fusion phenomena locally: highly concentrated energy and instantaneous bursts produce extremely high instantaneous temperatures, but the total energy is insufficient to sustain itself, so it mainly manifests as cavitation and impact rather than an overall heating stove (suitable for rib-shielded scenarios). The system automatically generates corresponding treatment dosage parameters based on the pre-stored treatment parameter model in the database. If manual adjustment of parameters is required (such as for specific lesions), medical staff can modify the above parameters in the UI interface.

[0037] Step 4: The high-frequency power source device 3 adjusts the focused ultrasound energy of the self-focusing ultrasound transducer according to the generated treatment dose parameters; the TPS software control system synchronously adjusts the multi-axis drive unit of the treatment head system 1, moves the focus of the self-focusing ultrasound transducer to each treatment point according to the set treatment step distance, and monitors the lesion status in real time through B-ultrasound, which can ensure that the energy evenly covers each treatment point of the lesion, greatly improving the efficiency and thoroughness of tissue inactivation. Specifically, in the UI interface of the TPS software control system 8, clicking "Start Treatment" sends treatment parameter instructions to the high-frequency power source device 3. After receiving the instructions, the radio frequency control board of the high-frequency power source device 3 drives the radio frequency generator to generate focused ultrasound energy according to the set parameters. The energy is transmitted to the long focal length self-focusing ultrasound transducer of the treatment head system 1 through the radio frequency line. The transducer focuses the energy on the lesion area to achieve a thermal superposition cavitation effect: the thermal energy raises the local temperature of the lesion to 60°C (causing coagulative necrosis of the tissue), and the mechanical energy is released instantaneously at an energy density of 1810 J / cm³ (generating a cavitation effect and breaking cells).

[0038] Meanwhile, the respiratory synchronization detection board of the high-frequency power source device 3 collects the patient's respiratory signal through the respiratory sensor of the patient carrier device 6, controls the energy to be emitted at the end of expiration (to avoid lesion displacement caused by breathing), and ensures that the energy is accurately applied to the lesion.

[0039] After each treatment point's energy emission is completed, the TPS software control system 8 sends a focus movement command to the treatment head system 1, driving the X1 axis to move to the next treatment point by the required step distance. When all treatment points along a treatment line are completed, the system drives the Y1 axis to move by the required step distance to begin treatment of the next treatment line, until the entire treatment line is covered. A comparison of the energy and parameters of thermal effects, cavitation effects, and thermal superposition cavitation effects can be found in [link to relevant documentation]. Figure 12 .

[0040] During the movement, the grating ruler and encoder of the treatment head system 1 provide real-time feedback of X1 and Y1 axis displacement data. If the displacement deviation exceeds the allowable value, the system automatically adjusts the movement parameters to ensure accurate focus position. The power distribution device 2 provides stable power supply to the treatment head system 1 and the high-frequency power source device 3 in real time. If a circuit overload occurs, the circuit breaker automatically cuts off the power supply, triggers "treatment pause" and alarm.

[0041] During operation, the ultrasound head of the treatment head system 1 acquires ultrasound images of the lesion area in real time and transmits them to the TPS software control system 8 through the video acquisition system. The system compares the real-time images with the initial images acquired in step 2 and displays the grayscale change curve on the UI interface. Medical staff can observe the ablation status of the lesion through the B-ultrasound monitor (such as an increase in gray level in the lesion area, indicating tissue necrosis). If any abnormality is found (such as a change in gray level in the rib area), they can click "Emergency Pause," and the system will immediately stop energy emission and resume treatment after the problem is investigated.

[0042] Step 5: During or after the operation, compare the real-time images acquired by the monitoring with the preset initial images of the lesions. Based on the comparison results, select to continue running, adjust the running parameters and run the treatment, or run the treatment, and generate an operation result report.

[0043] Specifically, after all treatment points have completed energy focusing, the TPS software control system 8 automatically enters the "efficacy evaluation" module, extracts the grayscale data of the real-time image after energy focusing and the initial image, and calculates the grayscale difference of each treatment point: when the grayscale difference is ≥ the preset threshold, the corresponding area is determined to be an "effective ablation area"; the ratio of the effective ablation area to the lesion treatment area is calculated. If the ratio is ≥ 95%, the treatment is determined to be "acceptable"; if the ratio is < 95% (such as insufficient ablation of the rib-covered area), the system prompts "re-treatment is required", and medical staff can select "adjust parameters" (such as increasing the power to 4000-6000W), return to step 3 to regenerate the treatment plan, and perform supplementary treatment on the unablated areas.

[0044] Once the treatment goals are achieved, the TPS software control system automatically generates a treatment result report. At the same time, the system stores all treatment process data (initial images, pre-scan 3D images, real-time images, and treatment parameters) in a MySQL database for easy follow-up on efficacy and clinical review.

[0045] This invention is currently mainly used for the treatment of uterine fibroids. Both cavitation and thermal superimposed cavitation modes can be used for the treatment of liver cancer, but the thermal superimposed cavitation mode performs better in treating liver cancer with rib obstruction. It can create a highly efficient tissue inactivation area in the lesion that combines thermal coagulation and cavitation damage, improving treatment efficiency by more than 30% while ensuring no thermal or mechanical damage. Post-treatment anatomical diagrams are shown below. Figure 13 .

[0046] In summary, this invention can significantly improve tissue inactivation efficiency and shorten treatment time, enhance the thoroughness of lesion tissue inactivation, and ensure that energy release is strictly limited to the focal area, preventing tissue heating along the sound wave propagation path and maintaining the safety of the treatment path. It provides a guarantee for one-time non-invasive or minimally invasive treatment of various solid malignant tumors such as liver cancer, kidney cancer, and pancreatic cancer, and also provides a new solution to the problems of precision, efficiency, safety, and non-invasiveness in complex treatment environments such as human tissue obstruction in the sound channel and deep target areas.

[0047] The specific embodiments described above further illustrate the purpose, technical solution, and beneficial effects of the present invention. It should be understood that the above description is only a specific embodiment of the present invention and is not intended to limit the scope of protection of the present invention. Any modifications, equivalent substitutions, improvements, etc., made within the spirit and principles of the present invention should be included within the scope of protection of the present invention.

Claims

1. An ultrahigh intensity self-focusing ultrasound treatment system, characterized by, include: The patient support device (6) is located below the ultrasound coupling device (5) and moves the patient below the treatment head system (1); The treatment head system (1) includes an ultrasound treatment head (1.1) and a multi-axis drive unit. The multi-axis drive unit moves the B-ultrasound head inside the ultrasound treatment head (1.1) to the epidermis above the patient's lesion to acquire real-time B-ultrasound images of the target lesion. The treatment head system (1) also includes a self-focusing ultrasound transducer. The self-focusing ultrasound transducer includes a short-focal-length transducer and a long-focal-length transducer adapted to lesions of different depths. The B-ultrasound head, the short-focal-length transducer, and the long-focal-length transducer are rotated and switched by a servo motor to synchronously complete lesion monitoring and energy focusing. The TPS software control system (8) adjusts the position of the patient support device (6) according to the acquired B-ultrasound image information, so that the lesion is moved to the focusing range of the self-focusing ultrasound transducer inside the ultrasound treatment head (1.1); and the TPS software control system (8) also automatically delineates the lesion boundary and ultrasound treatment channel according to the B-ultrasound image information, generates treatment points, and automatically selects the thermal effect, cavitation effect or thermal superimposed cavitation effect treatment mode, and generates corresponding treatment dose parameters. The high-frequency power source device (3) has an output power range of 100W to 6000W. It is used to adjust the focused ultrasound energy of the self-focusing ultrasound transducer according to the selected treatment mode and the generated treatment dose parameters, and to make the treatment head system (1) synchronously adjust the multi-axis drive unit to move the transducer focus to each treatment point according to the set treatment step distance. Furthermore, the TPS software control system (8) is also used to compare the real-time B-ultrasound images acquired during or after treatment with the preset initial images of the lesion. When the grayscale difference between the real-time image and the initial image is greater than or equal to the preset threshold, the corresponding area is determined to be an effective ablation area. If the effective ablation area does not cover the lesion treatment area, the system prompts that additional treatment is needed. After the medical staff selects and adjusts the treatment parameters, the system returns to regenerate the treatment plan to treat the unablated area.

2. An ultrahigh intensity self-focused ultrasound treatment system according to claim 1, wherein, The treatment step distance can be manually set within the range of 0.5mm to 10mm. The TPS software control system (8) generates real-time two-dimensional images based on the ultrasound layer corresponding to each step distance, which are used to compare the lesion location and ablation status with the initial images.

3. The ultra-high intensity self-focusing ultrasound therapy system according to claim 1, characterized in that, The patient support device (6) is also equipped with a respiratory synchronization device, which is used to collect the patient's respiratory signal and control the energy to be emitted at the end of exhalation.

4. The ultra-high intensity self-focusing ultrasound therapy system according to claim 1, characterized in that, It also includes a water treatment device (4), which uses a PLC as the control core to generate degassed water and deliver it to the ultrasonic treatment head (1.1) and the ultrasonic coupling device (5).

5. The ultra-high intensity self-focusing ultrasound therapy system according to claim 4, characterized in that, The ultrasound coupling device (5) is a movable water tank, which is adjusted in longitudinal height by an adjustable movable leg installed on the patient support device (6), and a sound-permeable membrane is pasted on the bottom of the water tank.

6. The ultra-high intensity self-focusing ultrasound therapy system according to claim 5, characterized in that, It also includes a control device (7), which is electrically connected to the treatment head system (1), the high-frequency power source device (3), the water treatment device (4), the ultrasound coupling device (5), the patient carrier device (6), and the TPS software control system (8).

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