Focused ultrasound, imaging, temperature measurement, fusion integrated closed-loop treatment system and method

Abstract

The application discloses a focused ultrasound, imaging, temperature measurement, fusion integrated closed loop treatment system and method, which comprises a signal source, an HIFU driving module, a matching network, an HIFU imaging and temperature measurement integrated composite probe, a tissue to be treated or a tissue phantom, a coupling water tank, a three-dimensional motion platform and an upper computer control module. In one aspect, the application integrates treatment, imaging and temperature measurement in the same acoustic channel, eliminates spatial deviation, realizes accurate correspondence between the focal point position and the B-ultrasound image, non-invasively obtains the real temperature rise inside the tissue by using the central B-ultrasound echo, and avoids the problems of contact interference and high cost of MRI. In another aspect, the temperature value is accurately mapped to the B-ultrasound image pixel through spatial registration, combined with time-sharing synchronous control, the interference of the treatment sound field on imaging and temperature measurement is inhibited, temperature field visualization and closed loop regulation are realized, and the treatment safety and effectiveness are significantly improved.

Description

Technical Field

[0001] This invention belongs to the field of medical device or biomedical engineering technology, specifically relating to high-intensity focused ultrasound (HIFU) therapy and image-guided monitoring technology. It also relates to an integrated closed-loop treatment system combining focused ultrasound, imaging, temperature measurement, and fusion. Furthermore, this invention relates to an integrated closed-loop treatment control method combining focused ultrasound, imaging, temperature measurement, and fusion. Background Technology

[0002] High-intensity focused ultrasound (HIFU) is a therapeutic technique that uses a transducer to focus acoustic energy onto a localized area within the body or a tissue phantom. At the focal point, it generates high sound intensity and energy density, causing localized tissue temperature rise, coagulative necrosis, or cavitation effects. It is used for tumor ablation, tissue fragmentation, pain management, hemostasis, and other therapeutic research. Compared to traditional invasive treatments, HIFU is non-invasive or minimally invasive, with controllable focus and repeatable effects. Accurately locating the treatment focus, real-time monitoring of changes in the target area, and controlling temperature changes within the focal area are crucial for ensuring the effectiveness and safety of HIFU treatment. Existing HIFU systems often use ultrasound or MRI for monitoring. Ultrasound has advantages such as good real-time performance, low cost, easy availability of equipment, and suitability for laboratory platform construction, making it suitable for integration with HIFU treatment probes to form a real-time monitoring system. However, relying solely on ultrasound images for HIFU monitoring still has shortcomings. Specifically, during HIFU treatment, changes in focal temperature directly affect the treatment dose and safety boundaries. Without temperature feedback, problems such as undertreatment, focal shift, local overheating, or damage to adjacent tissues may occur. Therefore, combining ultrasound imaging with ultrasound temperature measurement, and further coordinating with a three-dimensional motion platform, power drive, and host computer control system, can construct a more suitable closed-loop monitoring platform for HIFU treatment for experimental research and equipment development.

[0003] Existing HIFU (High-Intensity Focused Ultrasound) transducers mainly include single-element spherical focusing transducers, bowl-shaped focusing transducers, ring array transducers, phased array transducers, and planar array transducers with acoustic lenses. Among these, single-element or bowl-shaped HIFU transducers have relatively simple structures, and the acoustic energy can easily form a fixed focus on the axis, making them suitable for experimental research, ex vivo tissue ablation, small animal experiments, and some fixed-focus treatment applications. Ring array or phased array transducers can achieve focus position adjustment or multi-focus output through multi-element phase control, but they have a large number of drive channels, resulting in higher circuit complexity, cost, and packaging difficulties. For laboratory research or early prototype development, HIFU transducers are a common type of therapeutic ultrasound experimental device due to their intuitive structure, obvious focusing effect, and ease of integration with water tanks or three-dimensional motion platforms.

[0004] In image-guided HIFU treatment systems, existing systems typically use ultrasound or MRI for monitoring. MRI offers good soft tissue resolution and accurate temperature field monitoring through magnetic resonance thermometry, but its high cost, system complexity, and limitations in real-time performance and experimental convenience make it more suitable. In contrast, ultrasound offers advantages such as lower cost, better real-time performance, smaller size, ease of use, and integration with experimental platforms, making it widely used in clinical HIFU equipment and laboratory HIFU research. Traditional ultrasound-guided HIFU systems typically use ultrasound probes to observe the treatment target location, tissue boundaries, grayscale changes in the treatment area, changes in strong echoes, or changes in air bubbles, thereby assisting the operator in determining the HIFU focal point and treatment effectiveness.

[0005] Existing ultrasound-monitored HIFU (High-Intensity Focused Ultrasound) treatment setups can be broadly categorized into off-axis, coaxial, and external types. Off-axis setups place the ultrasound probe to the side of the HIFU treatment probe, allowing the ultrasound imaging plane to observe the treatment area from the side. This method is relatively easy to implement, but there is an angle between the ultrasound imaging beam and the HIFU treatment beam, requiring additional calibration between the target location in the image and the actual HIFU focal point. External setups separate the ultrasound probe from the HIFU treatment transducer, allowing the operator to locate the treatment area by moving the ultrasound probe. This method offers high flexibility, but the spatial correspondence between the imaging area and the treatment focal point is not entirely stable. Coaxial setups place the ultrasound probe in the central region or central aperture of the HIFU transducer, maximizing the overlap between the ultrasound imaging beam and the HIFU treatment acoustic axis. This method facilitates direct observation of the focal area but places higher demands on probe encapsulation, central aperture size, beam obstruction, sealing coupling, and structural registration.

[0006] In terms of temperature monitoring, common methods in existing HIFU treatment systems include thermocouple measurement, infrared thermometry, MRI thermometry, and non-invasive temperature measurement based on ultrasound signals. Thermocouples or fiber optic temperature sensors can directly measure the temperature at a specific point, and are relatively simple to implement experimentally. However, they need to be inserted into tissue or a prosthetic body, which may disturb the HIFU acoustic field and local temperature field, and is not conducive to subsequent non-invasive applications. Infrared thermometers or infrared thermal imagers can achieve non-contact measurement, but mainly reflect surface temperature. They are not direct enough in reflecting the temperature rise in the HIFU focal area inside the tissue, especially when the focal point is located inside the tissue, where there may be a significant difference between the surface temperature and the internal focal temperature. MRI thermometry has high accuracy, but the system cost is high and the equipment is complex, making it unsuitable for quickly setting up a HIFU treatment monitoring platform in a general laboratory. Ultrasonic signal-based temperature measurement is a promising approach in recent years. It can estimate temperature changes by utilizing changes in sound velocity, echo time shift, scattering characteristics, echo amplitude, spectrum, or grayscale changes in ultrasound images caused by temperature increases. It has advantages such as compatibility with ultrasound imaging systems, good real-time performance, and suitability for monitoring the internal focal area.

[0007] Current motion control methods in HIFU treatment systems typically include manual adjustment, two-dimensional or three-dimensional mechanical displacement stage adjustment, robotic arm control, and electronic phased array focus deflection. Manual adjustment is simple in structure but suffers from poor repeatability and accuracy. Three-dimensional motion platforms can achieve precise positioning in the X, Y, and Z directions, making them suitable for laboratory acoustic field scanning, focus calibration, point-by-point ablation, and path planning. Robotic arm systems offer high flexibility but are costly and complex to control. Electronic phased arrays can achieve focus deflection without moving the transducer, but place high demands on the transducer array, drive channels, and phase control system. For experimental platforms using HIFU transducers, three-dimensional motion platforms are a practical mainstream solution, enabling focus position adjustment and multi-point scanning by moving the probe or sample.

[0008] In terms of workflow, traditional HIFU treatment typically includes steps such as pre-treatment localization, treatment parameter setting, single-point or multi-point HIFU irradiation, image observation, temperature or effect assessment, focus repositioning, and continued treatment. The operator first determines the target area using ultrasound, MRI, or other imaging methods, then sets the HIFU output power, sound pressure level, frequency, duty cycle, pulse repetition frequency, and single-point treatment time. During treatment, the HIFU transducer emits focused ultrasound towards the target area, the imaging system synchronously or intermittently acquires images of the treatment area, and temperature monitoring equipment or effect evaluation algorithms determine whether the treatment area has achieved the expected results. For multi-point treatment, the system also needs to move the focus point by point according to a preset path to ultimately complete the overall ablation of the target area.

[0009] However, existing technologies still have the following shortcomings; First, in existing HIFU systems, ultrasound probes are often arranged in a paraxial or external manner. There is an angle or relative position change between the ultrasound imaging beam and the HIFU treatment beam, which requires additional calibration between the target area position in the ultrasound image and the actual focal position of HIFU, resulting in insufficient intuitiveness and repeatability in positioning.

[0010] Second, infrared thermometry mainly reflects surface temperature, while thermocouple or fiber optic thermometry requires insertion into tissue or phantom, which can easily disturb the sound and temperature fields. MRI thermometry is costly and complex, so existing systems are still not convenient enough for real-time temperature rise monitoring of the focal region inside HIFU.

[0011] Third, the high sound pressure and high power of HIFU emission can easily cause artifacts in ultrasound images, unstable echo signals, and temperature measurement errors. If there is no reasonable timing control between treatment emission, ultrasound acquisition, and temperature measurement acquisition, the reliability of monitoring will decrease.

[0012] Fourth, existing systems often only adjust the power or temperature threshold individually, lacking a unified relationship between HIFU focal coordinates, ultrasound image coordinates, temperature measurement area coordinates, and three-dimensional platform coordinates, which is not conducive to multi-point scanning treatment and automatic closed-loop control.

[0013] To address the aforementioned shortcomings, CN115252107A discloses a focused ultrasound tumor treatment device comprising an ultrasound transmitting device, a control mechanism, and a temperature monitoring unit. Specifically, it uses a non-contact infrared temperature sensor to monitor the target area temperature in real time. A judgment module adjusts the sound pressure intensity based on a standard temperature value, and the sound pressure control unit outputs corresponding ultrasound commands. Real-time guidance from a remote attending physician is achieved through a data transmission circuit and an online communication unit. This effectively reduces the uncontrollable shape of thermally necrotic cells caused by cavitation, ensures the stability of the target area temperature, and improves the accuracy and effectiveness of treatment through real-time temperature monitoring and remote guidance. However, the following drawbacks still exist: 1) Although existing focused ultrasound therapy devices can locate and acquire images of the treatment target area through B-ultrasound equipment or other image acquisition mechanisms, the B-ultrasound probe and the HIFU treatment transducer are often arranged relatively independently. Spatial deviations are likely to exist between the treatment sound beam, the imaging sound beam and the actual focal area. Moreover, the operator needs to judge the correspondence between the target area position in the B-ultrasound image and the actual focal position of HIFU based on experience during the treatment process, which can easily lead to problems such as inaccurate focal positioning and incomplete consistency between the treatment area and the image display area.

[0014] 2) Infrared temperature sensors are mainly suitable for measuring surface or visible area temperature, but they are difficult to accurately reflect the temperature rise of the HIFU focal area inside tissue or phantom; thermocouples or contact temperature sensors can measure local temperature, but they will cause some disturbance to the sound field and tissue environment; MRI temperature measurement is expensive and the system is complex. Therefore, there is still room for improvement in the existing technology for real-time, internal, non-invasive or quasi-non-invasive temperature monitoring of the HIFU focal area. 3) Although some solutions have both ultrasound images and temperature data, the two often come from different sensors or different spatial locations, lacking effective fusion. If the temperature value cannot be accurately mapped to the specific location in the ultrasound image, the operator still finds it difficult to determine which area near the focal point has reached the treatment temperature and which area is at risk of overheating. It is also difficult to achieve image-based temperature field display and closed-loop control. 4) The high intensity of the sound field during HIFU treatment can easily interfere with the ultrasound imaging signal and the temperature echo signal during the treatment process, resulting in noise, streaks, artifacts or unstable temperature echoes in the ultrasound image. If there is a lack of reasonable time-sharing synchronization control between HIFU treatment emission, ultrasound image acquisition and ultrasound temperature measurement calculation, the reliability of temperature imaging results and treatment judgment will decrease. Summary of the Invention

[0015] The technical problem to be solved by the present invention is to overcome the shortcomings of the prior art and provide a completely new integrated closed-loop treatment system that combines focused ultrasound, imaging, temperature measurement and fusion.

[0016] Meanwhile, the present invention also relates to a closed-loop treatment control method integrating focused ultrasound, imaging, temperature measurement, and fusion.

[0017] To solve the above-mentioned technical problems, the technical solution adopted by the present invention is as follows: A closed-loop treatment system integrating focused ultrasound, imaging, temperature measurement, and fusion includes a signal source, a HIFU drive module, a matching network, a HIFU imaging and temperature measurement integrated composite probe, the tissue to be treated or a tissue phantom, a coupling water tank, a three-dimensional motion platform, and a host computer control module. The HIFU imaging and temperature measurement integrated composite probe includes a HIFU transducer with a central through-hole and an ultrasound probe placed within the central through-hole. The HIFU transducer is hollow and bowl-shaped, used to generate a focused HIFU beam to emit therapeutic ultrasound towards the target area. The HIFU transducer emits in a time-division manner, and one working cycle includes T1, T2, T3, T4, and T5, where T1 is the HIFU emission phase; T2 is the waiting / ringing avoidance phase; T3 is the ultrasound image acquisition phase; T4 is the central ultrasound echo temperature measurement acquisition phase; and T5 is the image-temperature fusion and closed-loop update phase. The ultrasound probe fuses image and temperature information using ultrasound imaging and echo temperature measurement of the target area, and the fusion includes the following steps: S1. Establish image coordinates First, the focal position of the HIFU transducer, the coordinates of the ultrasound image, and the temperature imaging area are spatially calibrated using a three-dimensional motion platform; then, the ultrasound image is represented as... ,in Indicates horizontal position. The depth position is determined by spatial calibration, and the HIFU focal coordinates are determined on the ultrasound image. and its surrounding region of interest (ROI); S2. Calculate local temperature For each scan line or ROI window in the ultrasound image, extract the pretreatment reference echo. Real-time echo during treatment ,calculate Based on these characteristics, the temperature change at this location is obtained using the aforementioned temperature measurement model. If the reference temperature is The estimated temperature at that location is: ; S3. Generate temperature map Temperature values ​​on discrete ROIs or scan lines are processed through interpolation, smoothing, or filtering to form a two-dimensional temperature map with the same size as the B-image. ; S4. Image Fusion Display Using the B-mode grayscale image as the structural background image, and the temperature map... Converted to pseudo-color image or isotherm and then superimposed onto ultrasound image: ,in This is the normalized B-mode ultrasound grayscale image. This is a pseudo-color or grayscale mapping corresponding to the temperature map. For weight fusion.

[0018] Preferably, the HIFU transducer emits focused ultrasound towards the target area according to the set power, sound pressure level, duty cycle, pulse repetition frequency, and single-point irradiation time. Because the high sound field intensity during HIFU emission can easily interfere with ultrasound images and temperature echoes, the system employs time-division synchronous control. Furthermore, by setting a waiting time after HIFU emission, strong sound field interference and transducer ringing effects can be avoided before the ultrasound probe acquires the image and echo signals, thereby improving image quality and temperature measurement stability. In addition, since both image acquisition and temperature echo acquisition are performed by the ultrasound probe, the temperature estimation results can be directly mapped to pixels, scan lines, or regions of interest in the ultrasound image.

[0019] In some specific implementations, step S1 determines the actual focal position of HIFU by hydrophone scanning, thermal materials, tissue phantoms, temperature rise points, or ultrasound-visible markers, and maps this focal position to the ultrasound image coordinate system and the three-dimensional motion platform coordinate system. After calibration, the operator can determine the corresponding position of the HIFU focal point in the ultrasound image and adjust the relative position between the HIFU composite probe or the sample to be tested through the three-dimensional motion platform so that the treatment focal point is aligned with the target area.

[0020] According to a specific embodiment and preferred aspect of the present invention, ultrasonic thermometry employs the echo time-shift method; the sound velocity temperature coefficient method; the echo amplitude, backscattered energy, and grayscale change method; or a multi-parameter fusion thermometry method. In the echo time-shift method, after the HIFU transducer is heated, the sound velocity, thermal expansion state, and scattering structure of the tissue or phantom in the focal region change, resulting in a minute time-shift of the echo signal at the same depth position relative to the pre-treatment reference signal. Let the pre-treatment reference echo be... The echo during or after treatment is Within the selected region of interest (ROI), the echo time shift can be calculated through cross-correlation: ,in It is a cross-correlation function. For candidate time delay, Echo time shift to maximize the cross-correlation function; In the sound velocity temperature coefficient method, the change of sound velocity in tissues or phantoms with temperature can be approximately expressed as: ,in For reference temperature, The speed of sound at the reference temperature, The temperature coefficient of sound speed is such that the relative change in sound speed can be deduced from the echo time shift or phase change. When, temperature changes ; In the methods of echo amplitude, backscattered energy, and grayscale variation, HIFU transducer heating alters local scattering characteristics, tissue structure, and echo intensity. Let the average echo amplitude within the ROI before treatment be... The average echo amplitude during treatment was Then the change in amplitude can be expressed as: The backscattering energy within the ROI before treatment was The backscatter energy during treatment is The energy change is as follows: If B-mode ultrasound grayscale images are used, let the average grayscale value within the ROI before treatment be [value missing]. The average gray level during treatment was The grayscale change is as follows: The above characteristics can be calibrated to establish a relationship with temperature changes through experiments. ,in These are calibration coefficients; In the multi-parameter fusion temperature measurement method, echo time shift is extracted simultaneously. echo strain Amplitude change Backscattering energy change and grayscale changes Multiple features are considered, and a multi-parameter fusion model is established: ,in These are the weight coefficients obtained through experimental calibration or model training.

[0021] Preferably, after HIFU heating, the sound velocity, thermal expansion state, and scattering structure of the tissue or phantom in the focal region change, resulting in a micro-shift of the echo signal at the same depth location relative to the pre-treatment reference signal.

[0022] In some specific implementations, for pulse echo imaging using the echo time-shift method, the equivalent axial displacement corresponding to the echo time shift can be approximately expressed as: ,in The velocity of sound in the tissue or coupling medium at a reference temperature, coefficient This indicates that the propagation path of the pulse echo includes the round-trip acoustic path.

[0023] Furthermore, in the echo time-shift method, the echo strain is calculated based on the displacement changes at different depth locations: Once the relationship between temperature change and echo time shift or echo strain is obtained through experimental calibration, an estimated value of the temperature change can be obtained, using a linear calibration model: ,in The change in temperature The coefficients are obtained through experiments using thermocouples, fiber optic thermometers, or thermal phantoms.

[0024] In some specific implementations, the sound velocity temperature coefficient method is applicable to tissue phantoms, gels, or ex vivo tissues with known sound velocity temperature coefficients or those obtainable through experimental calibration. The echo amplitude, backscattered energy, and grayscale change methods are relatively simple to calculate and suitable for integration with ultrasound image processing for determining the temperature rise trend in the focal region. For multi-parameter fusion thermometry, to improve temperature measurement stability, specific tissue phantoms can be calibrated first using thermocouples, fiber optic thermometers, or thermosensitive materials to establish the correspondence between echo characteristics and temperature changes, and then the temperature of the focal region can be estimated in real time during HIFU treatment.

[0025] According to another specific embodiment and preferred aspect of the present invention, the host computer control module receives ultrasound images, temperature imaging results, and the position information of the three-dimensional motion platform, and performs closed-loop adjustment according to preset control rules. When the temperature is lower than the target treatment temperature or the ultrasound image shows insufficient change in the treatment area, the system can increase the HIFU output power, extend the single-point irradiation time, increase the duty cycle, or reduce the scanning step distance. When the temperature reaches the target threshold and the image status meets the requirements, the system records the completion of the treatment point and controls the three-dimensional motion platform to move to the next treatment point. When the temperature exceeds the safety threshold, or when abnormal strong echoes, rapid expansion of bubble areas, tissue boundary movement, or focus shift occur in the ultrasound image, the system can reduce the HIFU output power, shorten the pulse action time, pause the emission, or reposition the target area.

[0026] According to another specific embodiment and preferred aspect of the present invention, the boundary of the target area is determined based on the ultrasound image, and a treatment scanning path is generated in conjunction with a three-dimensional motion platform. The three-dimensional motion platform moves the focal point of the HIFU transducer point by point along a preset path, so that the focal point sequentially acts on different positions within the target area. The system can execute the workflow of ultrasound positioning—HIFU emission—central ultrasound echo temperature measurement—temperature image fusion—parameter judgment—closed-loop adjustment—platform movement, thereby achieving continuous treatment and real-time monitoring of the target area. Through the above method, the operator can simultaneously observe the tissue structure, the HIFU focal point position, and the temperature distribution near the focal point in the same image, achieving visualized closed-loop control. When the highest temperature point deviates from the preset HIFU focal point position, the system can determine the focal point offset and correct the probe or sample position through the three-dimensional motion platform; when the temperature in the focal area reaches the target treatment threshold, the system records the treatment completion; when the temperature exceeds the safety threshold, the system reduces the HIFU power, shortens the action time, or pauses emission.

[0027] Therefore, this invention is not merely a simple combination of a HIFU transducer, an ultrasound probe, and a temperature measurement function. Instead, it achieves coaxial ultrasound imaging through the central through-hole of the HIFU transducer, estimates the temperature of the focal area through central ultrasound echo temperature measurement, displays temperature imaging by fusing ultrasound images with temperature information, and achieves real-time monitoring and closed-loop control of the HIFU treatment process through a three-dimensional motion platform and synchronous control. This working principle is beneficial for improving the positioning accuracy, temperature controllability, imaging stability, and treatment safety during HIFU treatment.

[0028] In addition, the signal source is used to generate the excitation signal required for HIFU treatment; the signal source can output an electrical signal with a preset frequency, amplitude, pulse width, duty cycle and pulse repetition frequency, and transmit the signal to the HIFU drive module.

[0029] The HIFU driver module amplifies the excitation signal output from the signal source, enabling it to drive the HIFU transducer to emit focused therapeutic ultrasound. This module includes a power amplifier, a power monitoring unit, and protection circuits.

[0030] The matching network is used to connect the HIFU drive module and the HIFU imaging and temperature measurement integrated probe to achieve impedance matching, reduce reflected power, and improve energy transmission efficiency.

[0031] The core component of the composite probe is a hollow bowl-shaped HIFU imaging and temperature measurement device, which mainly includes a hollow bowl-shaped HIFU transducer and an ultrasound probe (integrated ultrasound imaging / echo temperature measurement). The hollow bowl-shaped HIFU transducer generates the HIFU focused beam, emitting therapeutic ultrasound towards the target area. A central through-hole is located in the middle of the transducer. The ultrasound probe is placed inside the central through-hole, simultaneously performing ultrasound imaging and echo temperature measurement of the target area, achieving image and temperature information fusion. The composite probe's signal connection terminal connects the HIFU, ultrasound imaging, and temperature measurement signals to the host computer control module.

[0032] The tissue to be treated or the tissue phantom is placed in the coupling water tank as the target of HIFU treatment, and its position can be adjusted through a three-dimensional motion platform.

[0033] The coupling tank provides an acoustic coupling environment to reduce the impact of the air interface on ultrasonic propagation, thereby improving imaging and temperature measurement stability.

[0034] The three-dimensional motion platform is used to adjust the relative position of the HIFU imaging and temperature measurement integrated probe and the tissue or tissue phantom to be treated, so as to realize HIFU focus positioning, multi-point scanning and spatial registration.

[0035] The host computer control module completes parameter setting, HIFU output control, ultrasound image display, temperature display, three-dimensional motion platform control, data storage, and closed-loop control. Among them, the images and temperature data collected by the ultrasound probe are fused and displayed to achieve HIFU focus closed-loop control.

[0036] In short, the key improvements mentioned above lie in the composite probe structure, integrated imaging and temperature measurement, image-temperature fusion display, synchronous control, and closed-loop adjustment. The composite probe structure integrates a hollow bowl-shaped HIFU transducer and an ultrasound probe, allowing imaging and temperature acquisition to be completed on the same probe. The ultrasound probe multiplexes echo signals for temperature estimation, eliminating the need for an external temperature measurement probe and simplifying the structure. Temperature data is mapped onto the ultrasound image coordinates for visual overlay, facilitating intraoperative navigation and focus control. Combined with a three-dimensional motion platform, closed-loop coordination of HIFU output, imaging, and temperature information is achieved, improving treatment accuracy and safety.

[0037] Another technical solution of the present invention is: a closed-loop treatment control method integrating focused ultrasound, imaging, temperature measurement, and fusion, which adopts the above-mentioned integrated closed-loop treatment system integrating focused ultrasound, imaging, temperature measurement, and fusion, and includes the following steps: 1) Spatial calibration and target localization The system first uses a three-dimensional motion platform to spatially calibrate the focal position of the HIFU transducer, the coordinates of the ultrasound image, and the temperature imaging area; 2) Time-division multiplexing of HIFU transducer and central B-mode ultrasound echo acquisition The HIFU transducer emits focused ultrasound towards the target area according to the set power, sound pressure level, duty cycle, pulse repetition frequency, and single-point irradiation time. Simultaneously, it employs time-division synchronous control, with one working cycle including the HIFU emission phase T1, the waiting / ringing avoidance phase T2, the ultrasound image acquisition phase T3, the central ultrasound echo temperature measurement acquisition phase T4, and the image-temperature fusion and closed-loop update phase T5. By setting a waiting time after HIFU emission, strong sound field interference and transducer ringing effects can be avoided before the ultrasound probe acquires images and echo signals. In phase T3, the ultrasound probe acquires ultrasound images of the target area for observing tissue structures, phantom boundaries, bubbles, strong echoes, grayscale changes, or areas of thermal damage. In phase T4, echo signals from the same imaging area are acquired for temperature estimation. 3) Ultrasonic temperature measurement The method employs any one of the following: echo time-shift method; sound velocity temperature coefficient method; echo amplitude, backscattered energy and grayscale variation method; or multi-parameter fusion temperature measurement method. 4) Fusion imaging of ultrasound images and temperature information Based on the ultrasound probe, image and temperature information are fused by ultrasound imaging of the target area and echo temperature measurement acquisition. 5) Closed-loop control The host computer control module receives ultrasound images, temperature imaging results, and the position information of the three-dimensional motion platform. It simultaneously observes tissue structures, the HIFU focal point position, and the temperature distribution near the focal point in the same image, achieving visualized closed-loop control. When the highest temperature point deviates from the preset HIFU focal point position, the system can determine the focal point shift and correct the probe or sample position through the three-dimensional motion platform. When the temperature in the focal area reaches the target treatment threshold, the system records the treatment as complete. When the temperature exceeds the safety threshold, the system reduces the HIFU power, shortens the action time, or pauses transmission.

[0038] Due to the implementation of the above technical solutions, the present invention has the following advantages compared with the prior art: While existing focused ultrasound (HIFU) therapy devices can locate and acquire images of the treatment target area using ultrasound equipment or other image acquisition mechanisms, the ultrasound probe and HIFU transducer are often arranged relatively independently. Spatial deviations can easily exist between the treatment sound beam, the imaging sound beam, and the actual focal area. Moreover, during treatment, the operator needs to rely on experience to judge the correspondence between the target area position in the ultrasound image and the actual HIFU focal position, which can easily lead to problems such as inaccurate focal positioning and incomplete consistency between the treatment area and the image display area. At the same time, infrared temperature sensors are mainly suitable for measuring surface or visible area temperature and cannot accurately reflect the temperature rise of the HIFU focal area inside tissues or phantoms. The situation is complex; while thermocouples or contact temperature sensors can measure local temperature, they can cause disturbances to the acoustic field and tissue environment. MRI temperature measurement is costly and complex. Therefore, existing technologies still have room for improvement in real-time, internal, non-invasive or quasi-non-invasive temperature monitoring of the HIFU focal area. Furthermore, although some solutions simultaneously provide ultrasound images and temperature data, these often originate from different sensors or different spatial locations, lacking effective fusion. If the temperature value cannot be accurately mapped to a specific location in the ultrasound image, the operator still finds it difficult to determine which area near the focal point has reached the treatment temperature and which area is at risk of overheating. It also makes it difficult to achieve image-based temperature field display and closed-loop control. The high intensity of the sound field in HIFU treatment can easily interfere with ultrasound imaging and temperature echo signals during the treatment process, leading to noise, streaks, artifacts, or unstable temperature echoes in the ultrasound images. Furthermore, the lack of reasonable time-sharing synchronization control between HIFU treatment emission, ultrasound image acquisition, and ultrasound temperature calculation can reduce the reliability of temperature imaging results and treatment decisions. This invention, based on the integrated closed-loop treatment system of focused ultrasound, imaging, temperature measurement, and fusion, cleverly solves these shortcomings. Using this treatment system, through HIFU focused treatment, real-time central ultrasound imaging, central ultrasound echo temperature measurement, ultrasound image temperature fusion, and three-dimensional... By employing spatial registration and time-sharing synchronous closed-loop control of the motion platform, this invention achieves target localization, real-time monitoring, temperature feedback, and treatment parameter adjustment during HIFU treatment. Therefore, on the one hand, it integrates treatment, imaging, and temperature measurement into the same acoustic channel, eliminating spatial deviations and achieving precise correspondence between the focal position and the ultrasound image. Simultaneously, it utilizes central ultrasound echoes to non-invasively obtain the true internal tissue temperature rise, avoiding contact interference and the high cost of MRI. On the other hand, spatial registration accurately maps temperature values ​​to ultrasound image pixels, and combined with time-sharing synchronous control, it suppresses interference from the treatment sound field on imaging and temperature measurement, achieving temperature field visualization and closed-loop regulation, significantly improving treatment safety and effectiveness. Attached Figure Description

[0039] Figure 1 This is a schematic diagram of the overall structure of the integrated HIFU treatment, B-ultrasound imaging and ultrasound temperature measurement system in this embodiment; Figure 2 This is a time-division synchronous control timing diagram of HIFU transmission, ultrasound acquisition, and central ultrasound echo temperature measurement in this embodiment; Figure 3 This is a flowchart of the closed-loop control process for HIFU treatment monitoring in this embodiment; The components include: 1. Signal source; 2. HIFU drive module; 3. Matching network; 4. HIFU imaging and temperature measurement integrated composite probe; 40. HIFU transducer; 41. Ultrasound probe; 5. Tissue to be treated or tissue phantom; 6. Coupling water tank; 8. Three-dimensional motion platform; 9. Host computer control module. Detailed Implementation

[0040] To make the above-mentioned objects, features, and advantages of the present invention more apparent and understandable, the present invention will be described in detail below with reference to the accompanying drawings and specific embodiments. Many specific details are set forth in the following description to provide a thorough understanding of the present invention. However, the present invention can be practiced in many other ways different from those described herein, and those skilled in the art can make similar modifications without departing from the spirit of the present invention. Therefore, the present invention is not limited to the specific embodiments disclosed below.

[0041] In the description of this invention, it should be understood that the terms "center," "longitudinal," "lateral," "length," "width," "thickness," "upper," "lower," "front," "rear," "left," "right," "vertical," "horizontal," "top," "bottom," "inner," "outer," "clockwise," "counterclockwise," "axial," "radial," and "circumferential" indicate the orientation or positional relationship based on the orientation or positional relationship shown in the accompanying drawings. They are used only for the convenience of describing this invention and simplifying the description, and are not intended to indicate or imply that the device or element referred to must have a specific orientation, or be constructed and operated in a specific orientation. Therefore, they should not be construed as limitations on this invention.

[0042] Furthermore, the terms "first" and "second" are used for descriptive purposes only and should not be construed as indicating or implying relative importance or implicitly specifying the number of technical features indicated. Thus, a feature defined as "first" or "second" may explicitly or implicitly include at least one of that feature. In the description of this invention, "a plurality of" means at least two, such as two, three, etc., unless otherwise explicitly specified.

[0043] In this invention, unless otherwise explicitly specified and limited, the terms "installation," "connection," "joining," and "fixing," etc., should be interpreted broadly. For example, they can refer to a fixed connection, a detachable connection, or an integral part; they can refer to a direct connection or an indirect connection through an intermediate medium; they can refer to the internal communication of two components or the interaction between two components, unless otherwise explicitly limited. Those skilled in the art can understand the specific meaning of the above terms in this invention according to the specific circumstances.

[0044] In this invention, unless otherwise explicitly specified and limited, "above" or "below" the second feature can mean that the first feature is in direct contact with the second feature, or that the first feature is in indirect contact with the second feature through an intermediate medium. Furthermore, "above," "over," and "on top" of the second feature can mean that the first feature is directly above or diagonally above the second feature, or simply that the first feature is at a higher horizontal level than the second feature. "Below," "below," and "under" the second feature can mean that the first feature is directly below or diagonally below the second feature, or simply that the first feature is at a lower horizontal level than the second feature.

[0045] It should be noted that when an element is referred to as being "fixed to" or "set on" another element, it can be directly on the other element or there may be an intervening element. When an element is considered to be "connected to" another element, it can be directly connected to the other element or there may be an intervening element. The terms "vertical," "horizontal," "upper," "lower," "left," "right," and similar expressions used herein are for illustrative purposes only and do not represent the only possible implementation.

[0046] like Figures 1 to 3 As shown, the focused ultrasound, imaging, temperature measurement, and fusion integrated closed-loop treatment system of this embodiment includes a signal source 1, a HIFU drive module 2, a matching network 3, a HIFU imaging and temperature measurement integrated composite probe 4, the tissue to be treated or a tissue phantom 5, a coupling water tank 6, a three-dimensional motion platform 8, and a host computer control module 9.

[0047] Specifically, signal source 1 generates the excitation signal required for HIFU treatment. The signal source can output an electrical signal with a preset frequency, amplitude, pulse width, duty cycle, and pulse repetition frequency, and transmit this signal to the HIFU drive module 2. The HIFU imaging and temperature measurement integrated composite probe 4 is the core execution component, mainly including: a hollow bowl-shaped HIFU transducer 40 and an ultrasound probe 41 (integrated ultrasound imaging / echo temperature measurement). The hollow bowl-shaped HIFU transducer 40 generates a focused HIFU beam to emit therapeutic ultrasound towards the target area, with a central through-hole in the middle. The ultrasound probe 41 is placed inside the central through-hole, simultaneously completing ultrasound imaging and echo temperature measurement of the target area, achieving image and temperature information fusion. The composite probe signal connection terminal connects the HIFU, ultrasound imaging, and temperature measurement signals to the host computer control module. The HIFU drive module 2 amplifies the excitation signal output from the signal source, enabling it to drive the HIFU transducer 40 to emit focused therapeutic ultrasound. This module includes a power amplifier, a power monitoring unit, and protection circuits. Matching network 3 connects the HIFU drive module 2 and the HIFU imaging and temperature measurement integrated probe 4 to achieve impedance matching, reduce reflected power, and improve energy transmission efficiency. The tissue to be treated or tissue phantom 5 is placed in the coupling water tank 6 as the HIFU target; its position can be adjusted via the three-dimensional motion platform. The coupling water tank 6 provides an acoustic coupling environment to reduce the influence of the air interface on ultrasound propagation and improve imaging and temperature measurement stability. The three-dimensional motion platform 8 is used to adjust the relative position of the HIFU imaging and temperature measurement integrated probe 4 and the tissue to be treated or tissue phantom 5, enabling HIFU focus positioning, multi-point scanning, and spatial registration. The host computer control module 9 completes parameter setting, HIFU output control, ultrasound image display, temperature display, three-dimensional motion platform control, data storage, and closed-loop control. It fuses and displays the images and temperature data acquired by the ultrasound probe 41 to achieve HIFU focus closed-loop control.

[0048] In some specific implementations, the HIFU transducer emits in a time-division multiplexing manner, with one working cycle comprising T1, T2, T3, T4, and T5. T1 is the HIFU emission phase; T2 is the waiting / ringing avoidance phase; T3 is the ultrasound image acquisition phase; T4 is the central ultrasound echo temperature measurement acquisition phase; and T5 is the image-temperature fusion and closed-loop update phase. The HIFU transducer emits focused ultrasound towards the target area according to the set power, sound pressure level, duty cycle, pulse repetition frequency, and single-point irradiation time. Because the high sound field intensity during HIFU emission can easily interfere with ultrasound images and temperature echoes, the system employs time-division synchronous control. Furthermore, by setting a waiting time after HIFU emission, strong sound field interference and transducer ringing effects can be avoided before the ultrasound probe acquires the image and echo signals, thereby improving imaging quality and temperature measurement stability. In addition, since both image acquisition and temperature echo acquisition are performed by the ultrasound probe, the temperature estimation results can be directly mapped to pixels, scan lines, or regions of interest in the ultrasound image.

[0049] In this example, the actual focal position of HIFU is determined by hydrophone scanning, thermal materials, tissue phantoms, temperature rise points, or ultrasound-visible markers, and this focal position is mapped to the ultrasound image coordinate system and the three-dimensional motion platform coordinate system. After calibration, the operator can determine the corresponding position of the HIFU focal point in the ultrasound image and adjust the relative position between the HIFU composite probe or the sample to be tested through the three-dimensional motion platform so that the treatment focal point is aligned with the target area.

[0050] The ultrasound probe fuses image and temperature information by using ultrasound imaging of the target area and echo temperature measurement. The fusion process includes the following steps: S1. Establish image coordinates First, the focal position of the HIFU transducer, the coordinates of the ultrasound image, and the temperature imaging area are spatially calibrated using a three-dimensional motion platform; then, the ultrasound image is represented as... ,in Indicates horizontal position. The depth position is determined by spatial calibration, and the HIFU focal coordinates are determined on the ultrasound image. and its surrounding region of interest (ROI); S2. Calculate local temperature For each scan line or ROI window in the ultrasound image, extract the pretreatment reference echo. Real-time echo during treatment ,calculate Based on these characteristics, the temperature change at this location is obtained using the aforementioned temperature measurement model. If the reference temperature is The estimated temperature at that location is: ; S3. Generate temperature map Temperature values ​​on discrete ROIs or scan lines are processed through interpolation, smoothing, or filtering to form a two-dimensional temperature map with the same size as the B-image. ; S4. Image Fusion Display Using the B-mode grayscale image as the structural background image, and the temperature map... Converted to pseudo-color image or isotherm and then superimposed onto ultrasound image: ,in This is the normalized B-mode ultrasound grayscale image. This is a pseudo-color or grayscale mapping corresponding to the temperature map. For weight fusion.

[0051] Ultrasonic thermometry employs the echo time-shift method. After the HIFU transducer is heated, the sound velocity, thermal expansion state, and scattering structure of the tissue or phantom in the focal region change, causing a minute time shift in the echo signal at the same depth location relative to the pre-treatment reference signal. Let the pre-treatment reference echo be... The echo during or after treatment is Within the selected region of interest (ROI), the echo time shift can be calculated through cross-correlation: ,in It is a cross-correlation function. For candidate time delay, The echo time shift is used to maximize the cross-correlation function; for pulse echo imaging, the equivalent axial displacement corresponding to the echo time shift can be approximated as: ,in The velocity of sound in the tissue or coupling medium at a reference temperature, coefficient This indicates that the pulse echo propagation path includes a round-trip acoustic path; furthermore, the echo strain is calculated based on the displacement changes at different depth positions: Once the relationship between temperature change and echo time shift or echo strain is obtained through experimental calibration, an estimated value of the temperature change can be obtained, using a linear calibration model: ,in The change in temperature The coefficients are obtained through experiments using thermocouples, fiber optic thermometers, or thermal phantoms.

[0052] Ultrasonic thermometry uses the sound velocity temperature coefficient method, where the change in sound velocity in tissues or phantoms with temperature can be approximated as: ,in For reference temperature, The speed of sound at the reference temperature, The temperature coefficient of sound speed is such that the relative change in sound speed can be deduced from the echo time shift or phase change. When, temperature changes The sound velocity temperature coefficient method is applicable to tissue phantoms, gels, or ex vivo tissues whose sound velocity temperature coefficient is known or can be obtained through experimental calibration.

[0053] Ultrasonic thermometry uses echo amplitude, backscattered energy, and grayscale changes. HIFU transducer heating alters local scattering characteristics, tissue structure, and echo intensity. Let the average echo amplitude within the region of interest (ROI) before treatment be... The average echo amplitude during treatment was Then the change in amplitude can be expressed as: The backscattering energy within the ROI before treatment was The backscatter energy during treatment is The energy change is as follows: If B-mode ultrasound grayscale images are used, let the average grayscale value within the ROI before treatment be [value missing]. The average gray level during treatment was The grayscale change is as follows: The above characteristics can be calibrated to establish a relationship with temperature changes through experiments. ,in These are calibration coefficients. The calculation of echo amplitude, backscattered energy, and grayscale variation is relatively simple and suitable for integration with ultrasound image processing for determining the temperature rise trend in the focal region.

[0054] Ultrasonic temperature measurement employs a multi-parameter fusion method, simultaneously extracting echo time shift. echo strain Amplitude change Backscattering energy change and grayscale changes Multiple features are considered, and a multi-parameter fusion model is established: ,in These are the weighting coefficients obtained through experimental calibration or model training. For multi-parameter fusion thermometry, to improve temperature measurement stability, a specific tissue phantom can first be calibrated using thermocouples, fiber optic thermometers, or thermosensitive materials to establish the correspondence between echo characteristics and temperature changes. Then, the temperature of the focal region can be estimated in real time during HIFU treatment.

[0055] The host computer control module 9 receives ultrasound images, temperature imaging results, and the position information of the three-dimensional motion platform. It performs closed-loop adjustment according to preset control rules. When the temperature is lower than the target treatment temperature or the ultrasound image shows insufficient change in the treatment area, the system can increase the HIFU output power, extend the single-point irradiation time, increase the duty cycle, or reduce the scanning step distance. When the temperature reaches the target threshold and the image status meets the requirements, the system records the completion of the treatment point and controls the three-dimensional motion platform to move to the next treatment point. When the temperature exceeds the safety threshold, or when abnormal strong echoes, rapid expansion of bubble areas, tissue boundary movement, or focus shift occur in the ultrasound image, the system can reduce the HIFU output power, shorten the pulse action time, pause the emission, or reposition the target area. The system determines the target area boundary based on ultrasound images and generates a treatment scan path using a 3D motion platform. The 3D motion platform moves the HIFU transducer's focal point point-by-point along the preset path, sequentially applying the focal point to different locations within the target area. The system executes a workflow of ultrasound positioning, HIFU emission, central ultrasound echo temperature measurement, temperature image fusion, parameter judgment, closed-loop adjustment, and platform movement to achieve continuous treatment and real-time monitoring of the target area. Using this method, the operator can simultaneously observe tissue structures, the HIFU focal point location, and the temperature distribution near the focal point in the same image, achieving visualized closed-loop control. When the highest temperature point deviates from the preset HIFU focal point location, the system can determine the focal point shift and correct the probe or sample position using the 3D motion platform. When the temperature in the focal area reaches the target treatment threshold, the system records the treatment completion. When the temperature exceeds the safety threshold, the system reduces the HIFU power, shortens the action time, or pauses emission. Therefore, this invention is not merely a simple combination of a HIFU transducer, an ultrasound probe, and a temperature measurement function. Instead, it achieves coaxial ultrasound imaging through the central through-hole of the HIFU transducer, estimates the temperature of the focal area through central ultrasound echo temperature measurement, displays temperature imaging by fusing ultrasound images with temperature information, and achieves real-time monitoring and closed-loop control of the HIFU treatment process through a three-dimensional motion platform and synchronous control. This working principle is beneficial for improving the positioning accuracy, temperature controllability, imaging stability, and treatment safety during HIFU treatment.

[0056] In summary, a closed-loop treatment control method integrating focused ultrasound, imaging, temperature measurement, and fusion is proposed, which utilizes the aforementioned integrated closed-loop treatment system integrating focused ultrasound, imaging, temperature measurement, and fusion, and includes the following steps: 1) Spatial calibration and target localization The system first uses a three-dimensional motion platform to spatially calibrate the focal position of the HIFU transducer, the coordinates of the ultrasound image, and the temperature imaging area; 2) Time-division multiplexing of HIFU transducer and central B-mode ultrasound echo acquisition The HIFU transducer emits focused ultrasound towards the target area according to the set power, sound pressure level, duty cycle, pulse repetition frequency, and single-point irradiation time. Simultaneously, it employs time-division synchronous control, with one working cycle including the HIFU emission phase T1, the waiting / ringing avoidance phase T2, the ultrasound image acquisition phase T3, the central ultrasound echo temperature measurement acquisition phase T4, and the image-temperature fusion and closed-loop update phase T5. By setting a waiting time after HIFU emission, strong sound field interference and transducer ringing effects can be avoided before the ultrasound probe acquires images and echo signals. In phase T3, the ultrasound probe acquires ultrasound images of the target area for observing tissue structures, phantom boundaries, bubbles, strong echoes, grayscale changes, or areas of thermal damage. In phase T4, echo signals from the same imaging area are acquired for temperature estimation. 3) Ultrasonic temperature measurement The method employs any one of the following: echo time-shift method; sound velocity temperature coefficient method; echo amplitude, backscattered energy and grayscale variation method; or multi-parameter fusion temperature measurement method. 4) Fusion imaging of ultrasound images and temperature information Based on the ultrasound probe, image and temperature information are fused by ultrasound imaging of the target area and echo temperature measurement acquisition. 5) Closed-loop control The host computer control module receives ultrasound images, temperature imaging results, and the position information of the three-dimensional motion platform. It simultaneously observes tissue structures, the HIFU focal point position, and the temperature distribution near the focal point in the same image, achieving visualized closed-loop control. When the highest temperature point deviates from the preset HIFU focal point position, the system can determine the focal point shift and correct the probe or sample position through the three-dimensional motion platform. When the temperature in the focal area reaches the target treatment threshold, the system records the treatment as complete. When the temperature exceeds the safety threshold, the system reduces the HIFU power, shortens the action time, or pauses transmission.

[0057] Therefore, compared with the prior art, the technical solution of this patent has the following advantages: 1. By integrating an ultrasound probe through the central hole of the HIFU transducer, coaxial real-time imaging of the HIFU treatment focal area can be achieved, improving the intuitiveness of target area positioning and monitoring.

[0058] 2. The ultrasound probe is used for both ultrasound imaging and temperature echo acquisition. It does not require an additional independent temperature probe on the periphery of the ultrasound probe, which can reduce the structural complexity of the composite probe and reduce the obstruction or disturbance to the HIFU main sound beam.

[0059] 3. Estimate the temperature change in the HIFU focal region by estimating echo time shift, phase change, echo amplitude, backscatter energy, or B-mode grayscale change, and realize non-invasive or quasi-non-invasive temperature measurement based on B-mode echo signal.

[0060] 4. Temperature results and ultrasound images are obtained using the same ultrasound probe, and the two have a natural spatial correspondence, which makes it easy to overlay temperature pseudo-color images, isotherms or focal temperature values ​​on the ultrasound images to achieve fusion display of structural images and temperature information.

[0061] 5. By establishing the spatial correspondence between the HIFU focal point, the B-ultrasound image area, and the temperature imaging area through a three-dimensional motion platform, the registration accuracy of treatment, imaging, and temperature measurement can be improved.

[0062] 6. The synchronous control module enables time-division control of HIFU transmission, ultrasound acquisition, temperature calculation, and closed-loop updates, reducing the interference of the strong HIFU sound field on ultrasound images and temperature measurement signals.

[0063] 7. The system can perform closed-loop adjustment of HIFU power, duty cycle, treatment time, scanning step distance or three-dimensional motion platform position based on ultrasound images and temperature fusion maps, making it suitable for building a laboratory HIFU treatment monitoring platform and subsequent integrated composite treatment equipment.

[0064] The present invention has been described in detail above, with the aim of enabling those skilled in the art to understand and implement the invention. However, this description should not be construed as limiting the scope of protection of the invention. All equivalent changes or modifications made in accordance with the spirit and essence of the invention should be included within the scope of protection of the invention.

Claims

1. A closed-loop treatment system integrating focused ultrasound, imaging, temperature measurement, and fusion, comprising a signal source, a HIFU drive module, a matching network, a HIFU imaging and temperature measurement integrated composite probe, the tissue to be treated or a tissue phantom, a coupling water tank, a three-dimensional motion platform, and a host computer control module, characterized in that, The HIFU imaging and temperature measurement integrated probe includes a HIFU transducer with a central through-hole and an ultrasound probe placed inside the central through-hole. The HIFU transducer is hollow and bowl-shaped, used to generate a focused HIFU beam to emit therapeutic ultrasound towards the target area. The HIFU transducer emits in a time-sharing manner, and one working cycle includes T1, T2, T3, T4, and T5. T1 is the HIFU emission phase; T2 is the waiting / ringing avoidance phase; T3 is the ultrasound image acquisition phase; T4 is the central ultrasound echo temperature measurement acquisition phase; and T5 is the image-temperature fusion and closed-loop update phase. The ultrasound probe fuses image and temperature information using ultrasound imaging of the target area and echo temperature measurement acquisition, and the fusion includes the following steps: S1. Establish image coordinates First, the focal position of the HIFU transducer, the coordinates of the ultrasound image, and the temperature imaging area are spatially calibrated using a three-dimensional motion platform; then, the ultrasound image is represented as... ,in Indicates horizontal position. The depth position is determined by spatial calibration, and the HIFU focal coordinates are determined on the ultrasound image. and its surrounding region of interest (ROI); S2. Calculate local temperature For each scan line or ROI window in the ultrasound image, extract the pretreatment reference echo. Real-time echo during treatment ,calculate Based on these characteristics, the temperature change at this location is obtained using the aforementioned temperature measurement model. If the reference temperature is The estimated temperature at that location is: ; S3. Generate temperature map Temperature values ​​on discrete ROIs or scan lines are processed through interpolation, smoothing, or filtering to form a two-dimensional temperature map with the same size as the B-image. ; S4. Image Fusion Display Using the B-mode grayscale image as the structural background image, and the temperature map... Converted to pseudo-color image or isotherm and then superimposed onto ultrasound image: ,in This is the normalized B-mode ultrasound grayscale image. This is a pseudo-color or grayscale mapping corresponding to the temperature map. For weight fusion.

2. The integrated closed-loop treatment system combining focused ultrasound, imaging, temperature measurement, and fusion as described in claim 1, characterized in that, The HIFU transducer emits focused ultrasound to the target area according to the set power, sound pressure, duty cycle, pulse repetition frequency and single-point irradiation time.

3. The integrated closed-loop treatment system combining focused ultrasound, imaging, temperature measurement, and fusion as described in claim 1, characterized in that, In step S1, the actual focal position of HIFU is determined by hydrophone scanning, thermal materials, tissue phantoms, temperature rise points, or ultrasound visible markers, and this focal position is mapped to the ultrasound image coordinate system and the three-dimensional motion platform coordinate system. After calibration, the operator can determine the corresponding position of the HIFU focal point in the ultrasound image and adjust the relative position between the HIFU composite probe or the sample to be tested through the three-dimensional motion platform so that the treatment focal point is aligned with the target area.

4. The integrated closed-loop treatment system combining focused ultrasound, imaging, temperature measurement, and fusion as described in claim 1, characterized in that, Ultrasonic thermometry employs methods such as echo time-shift, sound velocity temperature coefficient, echo amplitude, backscattered energy, and grayscale variation, or multi-parameter fusion thermometry. In the echo time-shift method, after the HIFU transducer is heated, the sound velocity, thermal expansion state, and scattering structure of the tissue or phantom in the focal region change, causing a minute time-shift in the echo signal at the same depth relative to the pre-treatment reference signal. Let the pre-treatment reference echo be... The echo during or after treatment is Within the selected region of interest (ROI), the echo time shift can be calculated through cross-correlation: ,in It is a cross-correlation function. For candidate time delay, Echo time shift to maximize the cross-correlation function; In the sound velocity temperature coefficient method, the change of sound velocity in tissues or phantoms with temperature can be approximately expressed as: ,in For reference temperature, The speed of sound at the reference temperature, The temperature coefficient of sound speed is such that the relative change in sound speed can be deduced from the echo time shift or phase change. When, temperature changes ; In the methods of echo amplitude, backscattered energy, and grayscale variation, HIFU transducer heating alters local scattering characteristics, tissue structure, and echo intensity. Let the average echo amplitude within the ROI before treatment be... The average echo amplitude during treatment was Then the change in amplitude can be expressed as: The backscattering energy within the ROI before treatment was The backscatter energy during treatment is The energy change is as follows: If B-mode ultrasound grayscale images are used, let the average grayscale value within the ROI before treatment be [value missing]. The average gray level during treatment was The grayscale change is as follows: The above characteristics can be calibrated to establish a relationship with temperature changes through experiments. ,in These are calibration coefficients; In the multi-parameter fusion temperature measurement method, echo time shift is extracted simultaneously. echo strain Amplitude change Backscattering energy change and grayscale changes Multiple features are considered, and a multi-parameter fusion model is established: ,in These are the weight coefficients obtained through experimental calibration or model training.

5. The integrated closed-loop treatment system combining focused ultrasound, imaging, temperature measurement, and fusion as described in claim 4, characterized in that, In the echo time-shift method for pulse echo imaging, the equivalent axial displacement corresponding to the echo time shift can be approximately expressed as: ,in The velocity of sound in the tissue or coupling medium at a reference temperature, coefficient This indicates that the propagation path of the pulse echo includes the round-trip acoustic path.

6. The integrated closed-loop treatment system combining focused ultrasound, imaging, temperature measurement, and fusion as described in claim 5, is characterized in that... In the echo time-shift method, the echo strain is calculated based on the displacement changes at different depth locations: Once the relationship between temperature change and echo time shift or echo strain is obtained through experimental calibration, an estimated value of the temperature change can be obtained, using a linear calibration model: ,in The change in temperature The coefficients are obtained through experiments using thermocouples, fiber optic thermometers, or thermal phantoms.

7. The integrated closed-loop treatment system combining focused ultrasound, imaging, temperature measurement, and fusion as described in claim 1, characterized in that, The host computer control module receives ultrasound images, temperature imaging results, and the position information of the three-dimensional motion platform. It performs closed-loop adjustment according to preset control rules. When the temperature is lower than the target treatment temperature or the ultrasound image shows insufficient change in the treatment area, the system can increase the HIFU output power, extend the single-point irradiation time, increase the duty cycle, or decrease the scanning step distance. When the temperature reaches the target threshold and the image status meets the requirements, the system records the completion of the treatment point and controls the three-dimensional motion platform to move to the next treatment point. When the temperature exceeds the safety threshold, or when abnormally strong echoes, rapidly expanding bubble areas, tissue boundary shifts, or focus shifts appear in the ultrasound image, the system can reduce the HIFU output power, shorten the pulse duration, pause transmission, or reposition the target area.

8. The integrated closed-loop treatment system combining focused ultrasound, imaging, temperature measurement, and fusion as described in claim 1, characterized in that, The target area boundary is determined based on the ultrasound image, and a treatment scanning path is generated by combining the three-dimensional motion platform. The three-dimensional motion platform moves the focal point of the HIFU transducer point by point according to the preset path, so that the focal point acts on different positions within the target area in sequence. The system can perform the workflow of ultrasound positioning, HIFU emission, central ultrasound echo temperature measurement, temperature image fusion, parameter judgment, closed-loop adjustment and platform movement to achieve continuous treatment and real-time monitoring of the target area.

9. The integrated closed-loop treatment system combining focused ultrasound, imaging, temperature measurement, and fusion as described in claim 1, characterized in that, The signal source generates the excitation signal required for HIFU treatment; and / or, the HIFU drive module amplifies the excitation signal output by the signal source, enabling it to drive the HIFU transducer to emit focused therapeutic ultrasound; and / or, the matching network connects the HIFU drive module to the HIFU imaging and temperature measurement integrated probe; and / or, the tissue to be treated or a tissue phantom is placed in a coupling water tank as the HIFU target, and its position can be adjusted by a three-dimensional motion platform; and / or, the coupling water tank provides an acoustic coupling environment to reduce the influence of the air interface on ultrasound propagation; and / or, the three-dimensional motion platform is used to adjust the relative position of the HIFU imaging and temperature measurement integrated probe and the tissue to be treated or the tissue phantom, realizing HIFU focus positioning, multi-point scanning, and spatial registration; and / or, the host computer control module completes parameter setting, HIFU output control, ultrasound image display, temperature display, three-dimensional motion platform control, data storage, and closed-loop control, wherein the images and temperature data acquired by the ultrasound probe are fused and displayed to achieve HIFU focus closed-loop control.

10. A closed-loop treatment control method integrating focused ultrasound, imaging, temperature measurement, and fusion, characterized in that, It employs the integrated closed-loop treatment system of focused ultrasound, imaging, temperature measurement, and fusion as described in any one of claims 1 to 9, and includes the following steps: 1) Spatial calibration and target localization The system first uses a three-dimensional motion platform to spatially calibrate the focal position of the HIFU transducer, the coordinates of the ultrasound image, and the temperature imaging area; 2) Time-division multiplexing of HIFU transducer and central B-mode ultrasound echo acquisition The HIFU transducer emits focused ultrasound to the target area according to the set power, sound pressure, duty cycle, pulse repetition frequency, and single-point irradiation time. Simultaneously, it employs time-division synchronous control, with one working cycle including the HIFU emission phase T1, the waiting / ringing avoidance phase T2, the ultrasound image acquisition phase T3, the central ultrasound echo temperature measurement acquisition phase T4, and the image-temperature fusion and closed-loop update phase T5. By setting a waiting time after HIFU emission, strong sound field interference and transducer ringing effects can be avoided before the ultrasound probe acquires images and echo signals. In phase T3, the ultrasound probe acquires ultrasound images of the target area for observing tissue structures, phantom boundaries, bubbles, strong echoes, grayscale changes, or areas of thermal damage. Echo signals within the same imaging region are acquired during the T4 phase for temperature estimation. 3) Ultrasonic temperature measurement The method employs any one of the following: echo time-shift method; sound velocity temperature coefficient method; echo amplitude, backscattered energy and grayscale variation method; or multi-parameter fusion temperature measurement method. 4) Fusion imaging of ultrasound images and temperature information Based on the ultrasound probe, image and temperature information are fused by ultrasound imaging of the target area and echo temperature measurement acquisition. 5) Closed-loop control The host computer control module receives ultrasound images, temperature imaging results, and the position information of the three-dimensional motion platform. It simultaneously observes tissue structures, the HIFU focal point position, and the temperature distribution near the focal point in the same image, realizing visualized closed-loop control. When the highest temperature point deviates from the preset HIFU focal point position, the system can determine the focal point shift and correct the probe or sample position through the three-dimensional motion platform. When the temperature in the focal area reaches the target treatment threshold, the system records the treatment as complete. When the temperature exceeds the safety threshold, the system reduces the HIFU power, shortens the operation time, or suspends transmission.

Images