Novel ultrasonic focusing thermal therapy device and application

Abstract

The invention relates to the technical field of medical equipment, and discloses a novel ultrasonic focusing thermal therapy device and application, and the device comprises an ultrasonic focusing module which comprises a plurality of transducer units and a focusing control unit; the temperature monitoring and feedback module comprises a temperature sensor unit and a temperature control feedback unit; the treatment mode module is connected with the ultrasonic focusing module and the temperature monitoring and feedback module and can select a continuous thermal therapy mode or a pulse thermal therapy mode according to set treatment requirements; the dynamic focus adjusting module comprises a depth adjusting unit and a transverse adjusting unit; the automatic safety protection module comprises a temperature over-limit protection unit and a power over-limit protection unit; and the non-thermal effect module comprises a cavitation effect unit and a mechanical effect unit. The focus position of ultrasonic waves can be freely adjusted in a three-dimensional space, the adjusting range of the focus position is wider, dynamic adjustment can be achieved according to treatment requirements, and full-coverage treatment can be conducted on all focus areas.

Description

Technical Field

[0001] The present invention relates to the technical field of medical equipment, and in particular to a novel ultrasonic focused thermal therapy device and its application. Background Art

[0002] As a non-invasive treatment technology, high-intensity focused ultrasound (HIFU) has been widely used in clinical treatment in recent years. Its core technology is to use the focusing effect of ultrasound to concentrate ultrasound energy in the lesion area, so that the tissue in the area undergoes coagulative necrosis under high temperature. This technology is particularly suitable for the treatment of solid tumors, such as uterine fibroids, liver cancer, pancreatic cancer, etc., and has the advantages of being non-invasive, precise, and fast in recovery. However, there are still some problems that need to be solved in the clinical application of existing ultrasound focused thermal therapy equipment.

[0003] Current ultrasound focused thermal therapy devices rely on a two-dimensional matrix transducer array. Although the focusing position of ultrasound waves can be controlled by adjusting the phase, the limited distribution of transducer units limits the range and accuracy of focus movement. Especially in the treatment of deep tumors, focus shifts are prone to occur, resulting in some lesions not being adequately treated. Summary of the invention

[0004] In view of the deficiencies in the prior art, the present invention provides a novel ultrasonic focused thermal therapy device and application to solve the problems of limited distribution of transducer units in current ultrasonic focused thermal therapy equipment and limited focus movement range and accuracy.

[0005] In the first aspect, the present invention provides the following technical solution, a novel ultrasound focused thermal therapy device, comprising:

[0006] An ultrasound focusing module, comprising a plurality of transducer units and a focusing control unit, wherein the transducer units are arranged in a two-dimensional matrix and the focusing control unit performs phase adjustment based on a beamforming algorithm, and the ultrasound focusing module is used to generate and accurately focus ultrasound waves to a target treatment area;

[0007] A temperature monitoring and feedback module, comprising a temperature sensor unit and a temperature control feedback unit. The temperature sensor unit is arranged in and around the target area to monitor the temperature of the treatment area in real time. The temperature control feedback unit adjusts the output power of the ultrasound focusing module in real time through a PID control algorithm based on the temperature data obtained by the temperature sensor unit.

[0008] The treatment mode module is connected to the ultrasound focusing module and the temperature monitoring and feedback module, and can select the continuous thermal therapy mode or the pulsed thermal therapy mode according to the set treatment requirements, and implement the required treatment mode by adjusting the working parameters of the ultrasound focusing module;

[0009] A dynamic focus adjustment module is connected to the ultrasound focusing module. The module includes a depth adjustment unit and a lateral adjustment unit. The treatment area is positioned by an image navigation system, and the focus position of the ultrasound wave is dynamically adjusted according to the depth and lateral position of the treatment area.

[0010] An automatic safety protection module is connected to the temperature monitoring and feedback module. The module includes a temperature over-limit protection unit and a power over-limit protection unit. When the temperature or power of the treatment area exceeds a preset value, the ultrasonic output power is automatically reduced or the treatment is suspended;

[0011] The non-thermal effect module is connected to the ultrasound focusing module, and the module includes a cavitation effect unit and a mechanical effect unit. Through the interaction between microbubbles and ultrasound, the ultrasound focusing module is assisted to enhance the treatment function and the tumor tissue is destroyed through cavitation and mechanical effects.

[0012] Preferably, the specific implementation method of the transducer unit is that each transducer unit can independently adjust its phase, and the phase offset of each transducer unit is dynamically adjusted by calculating the relative distance between the transducer unit and the target treatment area to perform ultrasonic focusing, which is specifically implemented by the following formula:

[0013]

[0014] After calculating the distance, use the following formula to adjust the phase offset:

[0015]

[0016] Where f is the ultrasonic frequency, c is the propagation speed of the sound wave in the tissue;

[0017] The operating frequency range of the transducer unit is 0.5 MHz to 3 MHz, the diameter of each transducer unit is 5 mm to 10 mm, and the spacing between the units is 1 mm to 2 mm.

[0018] Preferably, the temperature monitoring and feedback module performs real-time temperature monitoring through a plurality of temperature sensors arranged in the treatment area, the sensors are capable of detecting a temperature range of 35°C to 80°C, and the monitored temperature data are sent to the temperature control feedback unit at a frequency of 10 times per second;

[0019] The temperature control feedback unit uses a PID control algorithm to adjust the ultrasonic output power by real-time calculation of the temperature feedback error. The PID control algorithm includes the following formula:

[0020]

[0021] Where, e(t) is the current temperature error, K p , K i and Kd They are proportional, integral and differential control coefficients respectively. The PID algorithm ensures that the temperature of the treatment area is always maintained within a safe range by controlling the ultrasonic output power.

[0022] Preferably, the continuous thermal therapy mode is specifically used to continuously heat the lesion area by ultrasound, and the mode ensures that the temperature of the lesion area is maintained between 60°C and 70°C by controlling the output power, and adjusts the power output by real-time temperature feedback, and the treatment time is set to 5 minutes to 15 minutes;

[0023] The pulsed thermal therapy mode controls the temperature fluctuation of the lesion area through intermittent ultrasonic action. The duration of each pulse is 1 second to 5 seconds, the pulse interval is 2 seconds to 10 seconds, and the temperature is controlled in the range of 45°C to 55°C.

[0024] Preferably, the depth adjustment unit analyzes the depth of the lesion area in real time through an image navigation system, automatically adjusts the ultrasound focus position, and the depth adjustment range is 3 cm to 10 cm, ensuring that the ultrasound can be accurately focused on target tissues at different depths;

[0025] The lateral adjustment unit can adjust the lateral position of the ultrasound focus within a range of 2 cm to 8 cm to accommodate lesions of different shapes and sizes.

[0026] Preferably, when the temperature of the treatment area is detected to be over 70°C, the over-temperature protection unit can automatically reduce the ultrasonic output power or suspend the treatment to prevent tissue damage caused by over-temperature, and issue a warning signal;

[0027] The over-power protection unit can automatically shut down a transducer unit when detecting that the power output of a transducer unit exceeds 5W.

[0028] Preferably, the cavitation effect unit induces cavitation effect by introducing microbubbles and utilizing low-intensity ultrasound. The vibration of the microbubbles generated by the cavitation effect can destroy the structure of tumor cells, causing the lesion tissue to lose its function.

[0029] The mechanical effect unit induces high-speed vibration of cells through microsecond ultrasonic pulses. The cell structure is destroyed during the vibration process, destroying the supporting structure of the tumor tissue, thereby assisting in the removal of the tumor tissue.

[0030] In a second aspect, the present invention provides the following technical solution, an application method of a novel ultrasound focused thermal therapy device, comprising the following steps:

[0031] S1. Image navigation to determine the location of the lesion: The patient's lesion site is obtained through the image navigation system, and the target area of ​​the ultrasound is determined according to the location, depth and size of the lesion;

[0032] S2. Set treatment parameters: Select the treatment mode and set the treatment parameters, including the frequency, output power, focus position and treatment time of the ultrasound according to the type of lesion and treatment requirements;

[0033] S3, Ultrasonic focusing: Ultrasonic waves are generated through the transducer unit of the ultrasonic focusing module, and the phase is adjusted using the beamforming algorithm so that the ultrasound waves can be accurately focused on the target treatment area to form a focus of concentrated heat;

[0034] S4. Real-time temperature monitoring: During the treatment process, the temperature sensor in the temperature monitoring module monitors the temperature changes of the lesion and its surrounding tissues in real time. The temperature control feedback unit uses the PID control algorithm based on the monitoring data to dynamically adjust the ultrasonic output power so that the temperature of the treatment area is always kept within the preset range;

[0035] S5. Treatment execution: Ultrasound is focused on the lesion area, and the thermal effect of ultrasound is used to heat the target tissue. The continuous thermal therapy mode is used for tumor ablation, and the pulsed thermal therapy mode is used for pain management.

[0036] S6, Automatic safety protection: During the treatment process, the automatic safety protection module monitors the temperature of the treatment area and the power output of the transducer unit. When the temperature or power exceeds the set range, the system automatically reduces the power or suspends the treatment;

[0037] S7. End of treatment: According to the set treatment time or feedback from the lesion, the ultrasonic output is automatically stopped and the treatment data is recorded.

[0038] In a third aspect, the invention provides the following technical solution: a computer device comprising a memory, a processor, and a computer program stored in the memory and executable on the processor, wherein the processor implements the application method of the above-mentioned novel ultrasonic focused thermal therapy device when executing the computer program.

[0039] In a fourth aspect, the present invention provides the following technical solution: a readable storage medium having a computer program stored thereon, wherein the computer program, when executed by a processor, implements the application method of the above-mentioned novel ultrasonic focused thermal therapy device.

[0040] The present invention provides a novel ultrasound focused thermal therapy device and application thereof. It has the following beneficial effects:

[0041] 1. The present invention adopts advanced three-dimensional phase control technology and combines it with a high-density two-dimensional transducer matrix to make the focus position of ultrasound freely adjustable in three-dimensional space, which is particularly suitable for the treatment of deep tumors. The adjustment range of the focus position is wider and can be dynamically adjusted according to the treatment needs, ensuring full coverage of all lesion areas and improving the accuracy of treatment.

[0042] 2. The present invention integrates multiple temperature sensor units, which can monitor the temperature changes of the entire treatment area in real time. Through the PID adaptive control algorithm, the temperature control feedback system can automatically adjust the output power of the ultrasound according to the real-time temperature data to ensure that the temperature of the treatment area is always within a safe range. At the same time, multi-point monitoring can avoid temperature blind spots caused by insufficient monitoring of a single sensor, thereby improving the safety and effectiveness of treatment.

[0043] 3. The present invention supports two modes: continuous thermal therapy mode and pulse thermal therapy mode, and can automatically select the appropriate treatment mode according to different conditions. For tumor ablation, the continuous thermal therapy mode is used to perform ablation at a continuous high temperature; for pain management or sensitive tissues, the pulse thermal therapy mode is used to reduce the heat load and provide a more comfortable and safe treatment experience.

[0044] 4. The system of the present invention not only has temperature over-limit protection, but also introduces power over-limit protection. Once the temperature of the treatment area or the power output of the transducer exceeds the preset range, the system will automatically reduce the power or suspend the treatment, and respond quickly through a multi-level feedback control system to avoid tissue damage. This design greatly improves the safety and reliability of the device in the actual treatment process. BRIEF DESCRIPTION OF THE DRAWINGS

[0045] Figure 1 It is a schematic diagram of tissue penetration and focal point positioning of the HIFU (high intensity focused ultrasound) ultrasound transducer of the present invention;

[0046] Figure 2 This is a schematic diagram of the process of cell membrane changes and coagulative necrosis under the action of HIFU of the present invention;

[0047] Figure 3 This is a system architecture diagram of the novel ultrasound focused thermal therapy device of the present invention;

[0048] Figure 4 This is a diagram of the ultrasonic focusing module architecture of the present invention;

[0049] Figure 5 It is the architecture diagram of the temperature monitoring and feedback module of the present invention;

[0050] Figure 6 This is a diagram of the treatment mode module architecture of the present invention;

[0051] Figure 7 This is a diagram of the architecture of the dynamic focus adjustment module of the present invention;

[0052] Figure 8 This is the architecture diagram of the automatic safety protection module of the present invention;

[0053] Fig. 9 This is a diagram of the non-thermal effect module architecture of the present invention. DETAILED DESCRIPTION

[0054] The technical solution of the present invention will be described clearly and completely below in conjunction with the accompanying drawings of the present invention. Obviously, the described embodiments are only part of the embodiments of the present invention, not all of the embodiments. Based on the embodiments of the present invention, all other embodiments obtained by ordinary technicians in this field without creative work are within the scope of protection of the present invention.

[0055] Embodiment 1

[0056] Reference Figure 1 - Fig. 9 In the first embodiment of the present invention, the present invention provides a novel ultrasound focused thermal therapy device, comprising:

[0057] 1. Implementation of Ultrasonic Focusing Module

[0058] The ultrasound focusing module consists of multiple transducer units and a focusing control unit. The transducer units are arranged in a two-dimensional matrix, and each unit can independently adjust its phase. In order to achieve precise ultrasound focusing, the system first calculates the relative distance between the transducer unit and the target treatment area, and the formula is as follows:

[0059]

[0060] According to this distance, the focus control unit dynamically adjusts the phase of each unit through the beamforming algorithm, the formula is:

[0061]

[0062] Where f is the ultrasonic frequency and c is the propagation speed of the sound wave in human tissue. Through precise calculation, it is ensured that the ultrasound can converge on the lesion area to form a high-energy thermal therapy focus for tissue ablation.

[0063] 2. Implementation of temperature monitoring and feedback module

[0064] In this embodiment, the temperature monitoring and feedback module includes a temperature sensor unit and a temperature control feedback unit. A plurality of temperature sensors are arranged in and around the treatment area to monitor the temperature of the lesion area in real time. The sensor can detect a temperature range of 35°C to 80°C and send temperature data to the temperature control feedback unit at a sampling frequency of 10 times per second.

[0065] The temperature control feedback unit adopts PID control algorithm to adjust the ultrasonic output power according to the real-time monitored temperature feedback. The PID control formula is as follows:

[0066]

[0067] Where, e(t) is the current temperature error, K p , K i and K d They are proportional, integral and differential control coefficients respectively. Through the PID algorithm, the system can dynamically adjust the power according to the actual temperature error to ensure that the temperature of the treatment area is always maintained within the set range.

[0068] 3. Detailed implementation of the treatment mode module

[0069] The treatment mode module in this embodiment provides a continuous thermal therapy mode and a pulse thermal therapy mode. The two modes achieve different types of treatment effects by controlling the output of ultrasound.

[0070] Continuous Hyperthermia Mode:

[0071] Design background: This mode is commonly used in tumor ablation therapy. The goal is to continuously heat the lesion tissue to a sufficiently high temperature (usually between 60°C and 70°C), thereby destroying the structure of tumor cells and causing irreversible damage.

[0072] Implementation details: In the continuous thermal therapy mode, the transducer unit in the ultrasound focusing module works continuously, and the ultrasound waves continue to act on the target area. In order to maintain a constant temperature, the temperature control feedback unit will continuously monitor the temperature of the treatment area. When the temperature is too high, the system will automatically reduce the output power of the ultrasound to prevent overheating and damage to surrounding healthy tissues. The treatment time can be set to 5 to 15 minutes according to the patient's specific lesion type. During this period, the image navigation system is used to ensure that the focus of the ultrasound waves is always concentrated on the lesion area to avoid drift or error in the treatment focus.

[0073] Pulse Hyperthermia Mode:

[0074] Design background: This mode is suitable for pain management and the treatment of other chronic diseases. Compared with the continuous heat therapy mode, the pulse mode reduces the impact on healthy tissues through short-term intermittent heating, while still being able to regulate regional temperature, thereby effectively managing inflammatory responses, pain, etc.

[0075] Implementation details: The pulsed hyperthermia mode achieves temperature control by setting the duration of each pulse (1 to 5 seconds) and the pulse interval (2 to 10 seconds). During each pulse, the ultrasound is focused on the target area and heated, and then the power output automatically stops, allowing the tissue to cool naturally in a short period of time. This mode is particularly suitable for treating symptoms such as chronic pain because it can avoid overheating of tissues while maintaining moderate temperatures. In addition, the pulsed hyperthermia mode can also reduce the discomfort caused by the treatment to the patient and improve the sustainability of the treatment.

[0076] In the treatment mode module, the frequency, power and treatment mode selection of ultrasound are adjusted through the underlying control algorithm, which involves multiple technologies such as signal generation, power regulation and feedback control.

[0077] Low-level signal processing:

[0078] When generating ultrasound, the system uses digital signal processing (DSP) technology to generate ultrasound signals of the required frequency and waveform. Through software control, DSP can accurately generate sine waves of different frequencies and combine them in the time domain to form ultrasound suitable for different treatment needs. The signal of each transducer unit is sent to the amplifier through modulation, thereby realizing dynamic adjustment of the output power.

[0079] When switching between treatment modes, the system adjusts the power output through pulse width modulation (PWM) technology to control the switch between continuous and pulse modes. In continuous mode, the system maintains a constant power output, while in pulse mode, the system periodically shuts down the ultrasound output and precisely controls the pulse duration and interval through PWM signals.

[0080] Thermodynamic model and feedback regulation:

[0081] In continuous hyperthermia mode, the system calculates the temperature changes caused by ultrasound in the tissue in real time based on the thermodynamic model of biological tissue. The Pennes bioheat transfer equation is used to predict the temperature distribution:

[0082]

[0083] Where T is temperature, ρ is tissue density, c p is the specific heat capacity, k is the thermal conductivity, and Q is the amount of heat generated by the ultrasound. Through real-time calculations, the system is able to adjust the output power based on the predicted temperature changes to avoid overheating.

[0084] Pulse width control in pulse mode:

[0085] The system uses a pulse width control (Pulse Width Control, PWC) algorithm to adjust the duty cycle of the pulse mode. The duty cycle determines the proportion of time that the ultrasound is turned on in a cycle. The duty cycle can be adjusted between 10% and 90%, allowing the system to control the average temperature change by changing the ratio of on and off without changing the ultrasound power. This process is achieved through a feedback loop, that is, the duty cycle is dynamically adjusted through the information fed back by the temperature sensor.

[0086] 4. Detailed implementation of dynamic focus adjustment module

[0087] The dynamic focus adjustment module ensures high precision and targeted treatment by precisely controlling the focus position and depth of ultrasound. The module contains a depth adjustment unit and a lateral adjustment unit, which work together to adapt to lesions of different positions and shapes.

[0088] Depth adjustment unit:

[0089] Design background: The depth of different lesions requires that the ultrasound focus can be adjusted dynamically to ensure that the ultrasound is focused on the optimal position of the lesion and avoid unnecessary damage to the surrounding healthy tissues.

[0090] Implementation details: Through image navigation systems (such as MRI, CT, etc.), the depth and morphological information of the lesion is captured and analyzed in real time. The depth adjustment unit automatically calculates the required ultrasound focus position based on these data, and accurately positions the ultrasound focus deep in the lesion by adjusting the phase and power output of the transducer unit. The depth adjustment range is 3 cm to 10 cm, which is suitable for a wide range of application scenarios from superficial tissue to deep tissue. The adjustment process is fully automated, and the system responds to image feedback in real time to ensure accuracy during treatment.

[0091] Lateral adjustment unit:

[0092] Design background: Lesions may not only be dot-like structures but often have large or irregular shapes, thus requiring the ultrasound focus to be adjustable in the lateral direction to cover the entire range of the lesion.

[0093] Implementation details: The lateral adjustment unit can adjust the lateral position of the ultrasound focus within a range of 2 cm to 8 cm. In specific operations, the system first determines the initial position of the ultrasound focus based on the morphological information of the lesion. During the treatment process, the system can gradually change the position of the ultrasound focus according to actual needs to cover the entire lesion area. This point-by-point treatment method ensures that each lesion part is accurately treated and effectively prevents omissions.

[0094] The core technology of the dynamic focus adjustment module lies in the combination of phase control algorithm and real-time image guidance technology.

[0095] Phase control and beamforming:

[0096] The phase adjustment of each transducer unit is achieved through a digital phase delay algorithm. Specifically, the system calculates the distance difference from each transducer unit to the focus according to the beamforming algorithm, and introduces a corresponding time delay to ensure that the ultrasonic waves emitted by all units are superimposed at the focus. The specific algorithm formula is:

[0097]

[0098] Among them, d iis the distance from the ith transducer unit to the focal point, d 0 is the distance of the reference point, and c is the propagation speed of ultrasound in the tissue. Through this time delay, the system can form a concentrated sound wave energy peak at the focus.

[0099] Image-guided real-time focus adjustment:

[0100] The system integrates image guidance technology (MRI, CT) and ultrasonic treatment control system. After processing, the image data is aligned with the coordinate system in the system to determine the three-dimensional position of the lesion in real time. Based on the image feedback data, the system dynamically adjusts the phase and output power of the transducer to keep the ultrasonic focus in the lesion area at all times.

[0101] The underlying control logic of depth and lateral adjustment:

[0102] The system adjusts the ultrasound focus by detecting the morphology and depth of the lesion in real time. The focus control algorithm of the transducer unit is based on the Fresnel diffraction model and calculates the phase difference on the ultrasound propagation path. By dynamically adjusting the phase, the system can move the focus position in real time in the vertical (depth) and horizontal (lateral) directions to ensure that the treatment covers the entire lesion. This adjustment process uses the fast Fourier transform (FFT) algorithm to perform signal analysis to optimize the ultrasound propagation path.

[0103] 5. Detailed implementation of the automatic security protection module

[0104] To ensure the safety of patients, the automatic safety protection module monitors the temperature and power output in real time during treatment and takes necessary protective measures.

[0105] Over-temperature protection unit:

[0106] Design background: During ultrasonic heating treatment, if the temperature is too high, it may cause irreversible damage to normal tissues. Therefore, a reliable temperature monitoring system is needed to automatically adjust the power output or suspend treatment when the temperature exceeds the set threshold.

[0107] Implementation details: The temperature over-limit protection unit automatically reduces the ultrasonic output power to prevent tissue overheating when the temperature of the treatment area exceeds 70°C based on the sensor data of the temperature monitoring and feedback module. If the temperature still cannot be reduced, the system will immediately suspend the treatment and issue an alarm to remind the operator to intervene. This unit ensures that the temperature of the treatment area is always maintained within a safe range to avoid excessive damage to the patient's tissue due to excessive temperature.

[0108] Power over limit protection unit:

[0109] Design background: In order to prevent the power output of a transducer unit from exceeding the safety range during equipment operation (such as transducer failure or system abnormality), real-time monitoring of the power output is required.

[0110] Implementation details: The power over-limit protection unit is responsible for monitoring the power output of each transducer unit. When it detects that the output power of a unit exceeds 5W, the system will automatically shut down the unit and record the fault information for subsequent maintenance. This function ensures that the power output during treatment is always within a safe range, avoiding the impact of equipment failure on treatment effect and patient safety.

[0111] The underlying logic of the automatic security protection module mainly involves real-time monitoring, anomaly detection and adaptive adjustment mechanisms.

[0112] Real-time monitoring and threshold detection:

[0113] The system has built-in multiple safety thresholds to detect abnormal temperature and power conditions. The temperature sensor signal is converted into a digital signal through an analog-to-digital converter (ADC) and transmitted to the central processing unit. The system performs real-time detection based on the safety threshold comparator. If the temperature exceeds the set safety threshold (such as 70°C), the temperature over-limit protection is triggered.

[0114] The power monitoring system is based on current sensors and power detection circuits to monitor the power output of each transducer unit in real time. When the power of a transducer unit exceeds 5W, the system will automatically shut down the unit through a circuit breaker and sound an alarm.

[0115] Adaptive adjustment mechanism:

[0116] When the temperature or power is abnormal, the system will not only trigger the protection mechanism, but also start the adaptive adjustment algorithm to automatically reduce the ultrasonic output power or suspend treatment. This adjustment is achieved through the PID control algorithm, that is, dynamically adjusting the control signal according to the temperature and power information fed back by the sensor to ensure that the system can quickly return to normal.

[0117] Fault diagnosis and logging:

[0118] Fault detection uses a diagnostic mechanism based on fuzzy logic algorithms, which can classify abnormal conditions, determine the severity of the fault, and take different levels of response measures. In addition, the system has a built-in data recording module that can record all fault information for subsequent maintenance and analysis.

[0119] 6. Detailed implementation of non-thermal effect module

[0120] The non-thermal effect module combines cavitation effect and mechanical effect, and uses the physical properties of ultrasound to achieve auxiliary destruction of tumor tissue, which is particularly suitable for high-difficulty tumor ablation treatment.

[0121] Cavitation effect unit:

[0122] Design background: Cavitation effect refers to the vibration and collapse of microbubbles when ultrasound acts in liquid, resulting in a local high-pressure and high-temperature environment, which in turn damages the surrounding tissues.

[0123] Implementation details: The cavitation effect unit introduces microbubbles and uses low-intensity ultrasound to induce vibration of the bubbles. Under the action of ultrasound, the bubbles vibrate, expand and contract, and eventually collapse to release energy. This energy can directly act on tumor cells, destroying their cell membranes and structures, causing tumor tissue to lose function. The advantage of the cavitation effect is that it efficiently destroys specific areas while having little impact on surrounding healthy tissues, which can assist the ultrasound focusing module to enhance the treatment effect.

[0124] Mechanical effect unit:

[0125] Design background: Mechanical effect refers to the mechanical force of ultrasound acting directly on tissues, causing mechanical damage to cells. This effect plays a key role in the physical destruction of tumors, especially in tumors that are difficult to ablate by pure thermal effect.

[0126] Implementation details: The mechanical effect unit generates microsecond ultrasonic pulses to induce high-speed vibration of tumor cells. During the vibration process, the internal structure of the cells is destroyed, leading to cell apoptosis or necrosis. In addition, the mechanical effect can destroy the supporting structure of the tumor, causing the tumor tissue to lose its physical supporting structure before being ablated by the thermal effect. This synergistic effect greatly improves the efficiency of tumor removal, especially for larger or irregularly shaped tumors.

[0127] The non-thermal effect module includes cavitation effect and mechanical effect, which achieves the purpose of assisting in destroying tumor tissue through the interaction between ultrasound and microbubbles.

[0128] Microbubble dynamics of cavitation effect:

[0129] The cavitation effect is achieved by generating microbubbles in a liquid environment. The pressure waves generated by ultrasound cause the bubbles to expand and contract, eventually collapsing. This process involves complex microbubble dynamics, and the system calculates the vibration behavior of the bubbles using the Rayleigh-Plesset equation:

[0130]

[0131] Where R(t) is the bubble radius, P g (t) is the gas pressure inside the bubble, P ∞ (t) is the external pressure, P vis the vapor pressure within the bubble. The system controls the intensity of the cavitation effect by real-time analysis and adjustment of the bubble vibration mode.

[0132] Mechanisms of cell structure damage caused by mechanical effects:

[0133] The mechanical effect is generated by high-intensity, short-duration ultrasonic pulses, which use the mechanical force of ultrasound to act directly on the tissue. The system optimizes the cell vibration frequency through the control algorithm of ultrasound frequency and pulse intensity, causing it to produce destructive vibrations. In the tissue, the cell membrane and cell nucleus will rupture due to excessive vibration, eventually leading to cell apoptosis. This process controls the pulse duration and frequency in real time through the signal processing algorithm, so that the mechanical effect is combined with the thermal effect to achieve a better treatment effect.

[0134] Embodiment 2:

[0135] In a second embodiment of the present invention, the present invention provides an application method of a novel ultrasound focused hyperthermia treatment device, comprising the following steps:

[0136] S1: Image navigation to determine the location of the lesion

[0137] Before treatment begins, the patient's lesion site is first obtained through an image navigation system (such as MRI or CT). The imaging system provides detailed three-dimensional information of the patient's lesion, including the location, size, depth, and morphology of the lesion. This information is used to guide the focusing operation of the ultrasound. Based on the image feedback, the operator or system automatically determines the focal position of the ultrasound and inputs the target area into the control system of the ultrasound focusing module to ensure that subsequent treatment is accurately positioned in the lesion area.

[0138] S2: Set treatment parameters

[0139] After determining the location of the lesion, the system or operator selects the appropriate treatment mode (continuous thermal therapy mode or pulsed thermal therapy mode) according to the patient's lesion type and treatment needs. The system will set the frequency, output power, focal position and treatment time of the ultrasound according to the selected mode. For example:

[0140] In tumor ablation therapy, continuous thermal therapy mode is selected with higher frequency and power to ensure long-term high-temperature heating;

[0141] When treating pain management or other sensitive areas, select the Pulsed Heat mode, which has a shorter power and duration to ensure gentle heating.

[0142] S3: Ultrasonic Focusing

[0143] After the treatment parameters are set, the transducer unit in the ultrasound focusing module starts working. The system uses a beamforming algorithm to accurately focus the energy of the ultrasound on the patient's lesion area. The transducer units are arranged in a two-dimensional matrix, and by dynamically adjusting the phase, the ultrasound can form a concentrated energy focus in space. This step ensures that the energy of the ultrasound is concentrated on the target area, thereby improving the treatment effect while reducing the impact on surrounding healthy tissues.

[0144] S4: Real-time temperature monitoring

[0145] While the ultrasound is focused, the temperature monitoring module monitors the temperature changes in the treatment area in real time through temperature sensors arranged in and around the lesion area. The monitored temperature data will be continuously fed back to the temperature control feedback unit. The temperature control feedback unit adjusts the ultrasound output power in real time based on the sensor data to ensure that the temperature of the treatment area remains within a safe set range. For example, in continuous hyperthermia mode, the temperature is maintained between 60°C and 70°C; in pulsed hyperthermia mode, the temperature is controlled between 45°C and 55°C. In this process, the system dynamically adjusts the ultrasound output power through temperature feedback to avoid overheating or underheating.

[0146] S5: Treatment Implementation

[0147] During the treatment, ultrasound waves continue to act on the affected area. The treatment process varies depending on the treatment mode:

[0148] Continuous Hyperthermia Mode: Ultrasound continuously heats the lesion area, maintaining high temperature for a long time to ablate the tumor or other lesion tissue. The treatment time is set at 5 to 15 minutes.

[0149] Pulse heat therapy mode: Ultrasound heats the lesion area in an intermittent manner to avoid the discomfort caused by long-term high-temperature heating and the impact on healthy tissues. The duration of each pulse is 1 to 5 seconds, and the pulse interval is 2 to 10 seconds.

[0150] S6: Automatic safety protection

[0151] During the treatment, the automatic safety protection module is responsible for real-time monitoring of the temperature of the treatment area and the power output of the transducer unit. When the temperature exceeds the set 70°C, the temperature over-limit protection unit automatically reduces the ultrasonic output power or suspends the treatment. If the power output of a transducer unit exceeds 5W, the power over-limit protection unit will automatically shut down the unit and send out a warning signal to ensure that the treatment process is safe and does not cause additional harm to the patient.

[0152] S7: End of treatment

[0153] When the treatment reaches the set time or the feedback from the treatment area reaches the expected level, the system automatically stops the output of ultrasound. The treatment data (such as temperature changes, output power, etc.) will be automatically recorded for analysis and archiving by the operator. The end of this step marks the completion of the entire treatment process. The operator can evaluate the treatment effect based on the recorded data and prepare for subsequent treatment.

[0154] Embodiment 3

[0155] The third embodiment of the present invention is based on the same inventive concept and proposes a computer-readable storage medium, which stores a computer program. When the computer program is executed by a processor, the steps of the application method of the new ultrasonic focused thermal therapy device of the above embodiment are implemented.

[0156] Embodiment 4

[0157] The fourth embodiment of the present invention is based on the same inventive concept and proposes a terminal, which includes: a processor and a memory; the processor and the memory communicate with each other; the memory is used to store instructions; the processor is used to execute the instructions in the memory to execute the application method of the new ultrasonic focused thermal therapy device of the above embodiment.

[0158] Example 5: Example for liver tumor ablation

[0159] In this embodiment, the patient is diagnosed with a large liver tumor and needs non-invasive ablation treatment. The process of tumor ablation using the new ultrasound focused thermal therapy device is as follows:

[0160] Image navigation to determine the lesion: MRI images are used to obtain the specific location, size and depth of the patient's liver tumor. Through image analysis, the system determined that the tumor is located deep in the liver and is about 5 cm in diameter.

[0161] Set treatment parameters: The operator selects the continuous thermal therapy mode, sets the ultrasound frequency to 1.5MHz, the output power to 80W, and the treatment time to 10 minutes. The system automatically calculates the focus position based on the size of the lesion.

[0162] Ultrasonic focusing and real-time temperature monitoring: The system focuses ultrasound to the center of the tumor through a two-dimensional matrix of transducer units, and monitors the temperature of the tumor area in real time through a temperature sensor. During treatment, the temperature is maintained at 65°C to 70°C.

[0163] Automatic safety protection and end of treatment: During treatment, the system monitors temperature and power in real time. When the preset temperature is reached, the power is automatically adjusted to maintain a stable treatment effect. After the treatment is completed, the system automatically stops the ultrasonic output and records the treatment data.

[0164] Through this embodiment, tumor tissue is effectively ablated while surrounding healthy tissue is not damaged.

[0165] Example 6: Example for treating chronic back pain

[0166] A patient suffered from chronic back pain for a long time, and the doctor decided to use a focused ultrasound thermal therapy device for non-invasive treatment to relieve the pain symptoms.

[0167] Image navigation determines the treatment area: First, a CT scan is used to determine the patient's pain source area, confirming that the lesion is located in the soft tissue of the back, about 3 cm from the surface.

[0168] Set treatment parameters: Since the treatment goal is to relieve pain rather than ablate lesions, the pulsed thermal therapy mode is selected, the output power is set to 50W, the pulse duration is 3 seconds, the pulse interval is 5 seconds, and the total treatment time is set to 15 minutes.

[0169] Ultrasonic focusing and real-time temperature monitoring: The system adjusts the ultrasound focus to focus on the pain source area, allowing the area to cool naturally during the pulse interval. The temperature is controlled at 45℃ to 50℃ during treatment to reduce the patient's pain and avoid thermal damage to surrounding tissues.

[0170] End of treatment: After the treatment, the patient's back pain was significantly relieved, and the operator recorded the treatment parameters and temperature data for reference in subsequent treatment.

[0171] This example demonstrates the use of pulsed thermal therapy mode in non-invasive pain treatment.

[0172] Embodiment 7: Embodiment for the treatment of uterine fibroids

[0173] A female patient was diagnosed with uterine fibroids and chose to use an ultrasound focused thermal therapy device for non-invasive treatment to reduce the size of the fibroids.

[0174] Image navigation to identify the lesion: Through joint analysis of ultrasound and MRI images, it was determined that the fibroid was located deep in the uterus, with a diameter of approximately 4 cm. The system locked the ultrasound focus on the center of the fibroid.

[0175] Set treatment parameters: The operator selects the continuous thermal therapy mode, sets the frequency to 2MHz, the output power to 90W, and the treatment time to 8 minutes. The system updates the location of the fibroid in real time through image navigation to ensure the accuracy of the ultrasound focus position.

[0176] Ultrasonic focusing and real-time temperature monitoring: Ultrasonic waves are focused on the fibroid area, and the temperature is maintained at 65°C to 70°C by continuous heating, which induces necrosis and contraction of fibroid tissue. At the same time, the temperature monitoring system continuously feeds back temperature changes to ensure that the treatment area does not exceed the set temperature range.

[0177] End of treatment and follow-up monitoring: After the treatment is completed, the system automatically stops output and records the treatment parameters and temperature changes. The patient's fibroids were significantly reduced in follow-up imaging examinations.

[0178] This embodiment demonstrates the application of a novel ultrasound focused thermal therapy device in the non-invasive treatment of uterine fibroids.

[0179] Example 8: Restoration treatment for soft tissue injury

[0180] An athlete suffered soft tissue injury due to training and used an ultrasound focused thermal therapy device for rehabilitation treatment to accelerate tissue repair.

[0181] Image navigation to determine the location of the injury: The injury site is determined by ultrasound imaging and is located deep in the leg muscles, about 4 cm from the surface.

[0182] Set treatment parameters: Select pulsed hyperthermia mode, set the output power to 40W, the pulse duration to 2 seconds, the pulse interval to 4 seconds, and the treatment time to 20 minutes.

[0183] Ultrasonic focusing and real-time temperature monitoring: The system locks the focus of ultrasound on the soft tissue injury site, uses pulsed thermal therapy mode to regulate local blood flow and promote tissue repair. During treatment, the temperature is maintained at 42°C to 48°C to avoid excessively high temperatures affecting tissue recovery.

[0184] End of treatment and rehabilitation follow-up: After the treatment, the system records the treatment data and recommends that the patient continue with multiple rehabilitation treatments so that the soft tissue injury gradually heals.

[0185] This embodiment demonstrates the use of the device in promoting soft tissue healing.

[0186] Although embodiments of the present invention have been shown and described, it will be appreciated by those skilled in the art that various changes, modifications, substitutions and variations may be made to the embodiments without departing from the principles and spirit of the present invention, and that the scope of the present invention is defined by the appended claims and their equivalents.

Claims

1. A novel ultrasound focused hyperthermia device, characterized in that: include: An ultrasound focusing module, comprising a plurality of transducer units and a focusing control unit, wherein the transducer units are arranged in a two-dimensional matrix and the focusing control unit performs phase adjustment based on a beamforming algorithm, and the ultrasound focusing module is used to generate and accurately focus ultrasound waves to a target treatment area; A temperature monitoring and feedback module, comprising a temperature sensor unit and a temperature control feedback unit. The temperature sensor unit is arranged in and around the target area to monitor the temperature of the treatment area in real time. The temperature control feedback unit adjusts the output power of the ultrasound focusing module in real time through a PID control algorithm based on the temperature data obtained by the temperature sensor unit. The treatment mode module is connected to the ultrasound focusing module and the temperature monitoring and feedback module, and can select the continuous thermal therapy mode or the pulsed thermal therapy mode according to the set treatment requirements, and implement the required treatment mode by adjusting the working parameters of the ultrasound focusing module; A dynamic focus adjustment module is connected to the ultrasound focusing module. The module includes a depth adjustment unit and a lateral adjustment unit. The treatment area is positioned by an image navigation system, and the focus position of the ultrasound wave is dynamically adjusted according to the depth and lateral position of the treatment area. An automatic safety protection module is connected to the temperature monitoring and feedback module. The module includes a temperature over-limit protection unit and a power over-limit protection unit. When the temperature or power of the treatment area exceeds a preset value, the ultrasonic output power is automatically reduced or the treatment is suspended; The non-thermal effect module is connected to the ultrasound focusing module, and the module includes a cavitation effect unit and a mechanical effect unit. Through the interaction between microbubbles and ultrasound, the ultrasound focusing module is assisted to enhance the treatment function and the tumor tissue is destroyed through cavitation and mechanical effects.

2. The novel ultrasound focused thermal therapy device according to claim 1, characterized in that: The specific implementation method of the transducer unit is that each transducer unit can independently adjust its phase, and by calculating the relative distance between the transducer unit and the target treatment area, the phase offset of each transducer unit is dynamically adjusted to perform ultrasonic focusing, which is specifically implemented by the following formula: After calculating the distance, use the following formula to adjust the phase offset: Where f is the ultrasonic frequency, c is the propagation speed of the sound wave in the tissue; The operating frequency range of the transducer unit is 0.5 MHz to 3 MHz, the diameter of each transducer unit is 5 mm to 10 mm, and the spacing between the units is 1 mm to 2 mm.

3. The novel ultrasound focused hyperthermia device according to claim 1, characterized in that: The temperature monitoring and feedback module performs real-time temperature monitoring through a plurality of temperature sensors arranged in the treatment area. The sensors can detect a temperature range of 35°C to 80°C and send the monitored temperature data to the temperature control feedback unit at a frequency of 10 times per second; The temperature control feedback unit uses a PID control algorithm to adjust the ultrasonic output power by real-time calculation of the temperature feedback error. The PID control algorithm includes the following formula: Where, e(t) is the current temperature error, K p , K i and K d They are proportional, integral and differential control coefficients respectively. The PID algorithm ensures that the temperature of the treatment area is always maintained within a safe range by controlling the ultrasonic output power.

4. The novel ultrasound focused thermal therapy device according to claim 1, characterized in that: The continuous thermal therapy mode is specifically used to continuously heat the lesion area through ultrasound. The mode ensures that the temperature of the lesion area is maintained between 60°C and 70°C by controlling the output power, and adjusts the power output through real-time temperature feedback. The treatment time is set to 5 minutes to 15 minutes; The pulsed thermal therapy mode controls the temperature fluctuation of the lesion area through intermittent ultrasonic action. The duration of each pulse is 1 second to 5 seconds, the pulse interval is 2 seconds to 10 seconds, and the temperature is controlled in the range of 45°C to 55°C.

5. The novel ultrasound focused thermal therapy device according to claim 1, characterized in that: The depth adjustment unit analyzes the depth of the lesion area in real time through the image navigation system, and automatically adjusts the ultrasound focus position. The depth adjustment range is 3 cm to 10 cm, ensuring that the ultrasound can be accurately focused on target tissues at different depths. The lateral adjustment unit can adjust the lateral position of the ultrasound focus within a range of 2 cm to 8 cm to accommodate lesions of different shapes and sizes.

6. The novel ultrasound focused thermal therapy device according to claim 1, characterized in that: When the temperature of the treatment area is detected to be over 70°C, the over-temperature protection unit can automatically reduce the ultrasonic output power or suspend the treatment to prevent tissue damage caused by over-temperature and send out a warning signal; The over-power protection unit can automatically shut down a transducer unit when detecting that the power output of a transducer unit exceeds 5W.

7. The novel ultrasound focused thermal therapy device according to claim 1, characterized in that: The cavitation effect unit introduces microbubbles and uses low-intensity ultrasound to induce cavitation effect. The microbubble vibrations generated by the cavitation effect can destroy the structure of tumor cells, causing the lesion tissue to lose function. The mechanical effect unit induces high-speed vibration of cells through microsecond ultrasonic pulses. The cell structure is destroyed during the vibration process, destroying the supporting structure of the tumor tissue, thereby assisting in the removal of the tumor tissue.

8. The application method of the novel ultrasound focused hyperthermia device is characterized in that: The novel ultrasound focused thermal therapy device according to any one of claims 1 to 7 comprises the following steps: S1. Image navigation to determine the location of the lesion: The patient's lesion site is obtained through the image navigation system, and the target area of ​​the ultrasound is determined according to the location, depth and size of the lesion; S2. Set treatment parameters: Select the treatment mode and set the treatment parameters, including the frequency, output power, focus position and treatment time of the ultrasound according to the type of lesion and treatment requirements; S3, Ultrasonic focusing: Ultrasonic waves are generated through the transducer unit of the ultrasonic focusing module, and the phase is adjusted using the beamforming algorithm so that the ultrasound waves can be accurately focused on the target treatment area to form a focus of concentrated heat; S4. Real-time temperature monitoring: During the treatment process, the temperature sensor in the temperature monitoring module monitors the temperature changes of the lesion and its surrounding tissues in real time. The temperature control feedback unit uses the PID control algorithm based on the monitoring data to dynamically adjust the ultrasonic output power so that the temperature of the treatment area is always kept within the preset range; S5. Treatment execution: Ultrasound is focused on the lesion area, and the thermal effect of ultrasound is used to heat the target tissue. The continuous thermal therapy mode is used for tumor ablation, and the pulsed thermal therapy mode is used for pain management. S6, Automatic safety protection: During the treatment process, the automatic safety protection module monitors the temperature of the treatment area and the power output of the transducer unit. When the temperature or power exceeds the set range, the system automatically reduces the power or suspends the treatment; S7. End of treatment: Automatically stop ultrasonic output and record treatment data according to the set treatment time or feedback from the lesion.

9. A computer device comprising a memory, a processor, and a computer program stored in the memory and executable on the processor, characterized in that: When the processor executes the computer program, the application method of the novel ultrasound focused thermal therapy device as claimed in claim 8 is implemented.

10. A readable storage medium, characterized in that: The readable storage medium stores a computer program, and when the computer program is executed by the processor, the application method of the novel ultrasonic focused thermal therapy device according to claim 8 is implemented.

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