Ablation system and method for cardiovascular balloon

Abstract

The invention discloses an ablation system and method for a cardiovascular balloon. The system comprises a multi-section temperature control balloon, a cooling rate control module, a flow control module, a pressure adjusting module, an intelligent feedback control module and a safety protection module. The method comprises the following steps: initializing a multi-section temperature control balloon, and deploying a cooling rate control module, a flow control module, a pressure regulation module, an intelligent feedback control module and a safety protection module; the initial temperature Ti, 0 of each section is obtained, the low temperature related to the treatment target is set as the target temperature Ti, target, and the refrigerant flow Fi, 0 and the initial pressure Pi, 0 of each section are initialized; in the real-time control stage of the freezing process, impedance change of cardiovascular tissue is monitored in real time to judge the freezing effect, and various control parameters in the cryoablation process are predicted and adjusted according to constantly changing real-time data; and monitoring whether abnormal temperature change or abnormal pressure change exists between the freezing balloon and the cardiovascular tissue, and if the abnormal temperature change or abnormal pressure change occurs, performing emergency treatment.

Description

Technical Field

[0001] The present invention relates to the technical field of medical devices, and particularly to an ablation system and method for a cardiovascular balloon. Background Art

[0002] Cardiovascular diseases are one of the main causes of death globally, and arrhythmias (such as atrial fibrillation) are common cardiovascular diseases. As a minimally invasive treatment method, cryoablation technology has been widely used in the treatment of arrhythmias in recent years. Cryoablation destroys the myocardial tissue with abnormal electrical signal conduction by cryogenic freezing, thereby achieving the treatment purpose.

[0003] Currently, the cryoablation systems on the market mainly use single-segment temperature-controlled balloons, and achieve cooling by circulating a refrigerant (such as liquid nitrogen or compressed gas) inside the balloon. However, the existing technologies have the following limitations: (1) Single-segment temperature control. Existing systems usually can only cool the entire balloon as a whole, and cannot achieve independent temperature control according to the lesion conditions in different regions, resulting in limited treatment effects; (2) Imprecise control of the cooling rate. The cooling rate control of existing systems relies on simple open-loop control, lacks real-time feedback and dynamic adjustment capabilities, and is prone to temperature fluctuations or non-compliance with the cooling rate standard; (3) Insufficient pressure regulation. During the cryoablation process, the pressure change inside the balloon is crucial for the treatment effect and safety, but existing systems lack a precise pressure monitoring and regulation mechanism; (4) Low degree of intelligence. Existing systems lack intelligent feedback control functions and cannot dynamically adjust ablation parameters according to real-time data (such as tissue impedance changes), making it difficult to achieve personalized treatment; (5) Insufficient safety: Existing systems have limited emergency handling capabilities in the event of abnormal temperature or pressure changes, presenting certain safety hazards.

[0004] With the progress of medical technology, the market demand for cryoablation systems is gradually developing towards multi-segment independent temperature control, precise cooling rate control, intelligent feedback regulation, and high safety. Especially in the treatment of complex arrhythmias, systems that can achieve precise ablation and reduce complications have broad application prospects.

[0005] With the increase in the number of cardiovascular disease patients and the progress of medical technology, the market demand for cryoablation systems is growing day by day. Especially in the treatment of complex arrhythmias, systems that can achieve multi-segment independent temperature control, precise cooling rate control, intelligent feedback regulation, and high safety have broad application prospects. However, the existing technologies cannot meet these demands, and there is an urgent need for a new type of cryoablation system to solve the above technical problems. Summary of the Invention

[0006] The object of the present invention is to provide an ablation system and method for a cardiovascular balloon, which are used to solve at least one of the above technical problems. Through the coordinated work of a multi-segment temperature control balloon, a cooling rate control module, a flow control module, a pressure regulation module, an intelligent feedback control module, and a safety protection module, the present invention can solve the problems existing in the prior art, such as single-segment temperature control, inaccurate cooling rate control, insufficient pressure regulation, low intelligence level, and insufficient safety. The present invention can achieve multi-segment independent temperature control, precise cooling rate control, intelligent feedback regulation, and high safety, thereby improving the treatment effect and safety of cryoablation and meeting the market demand.

[0007] The embodiments of the present invention are implemented as follows:

[0008] An ablation system for a cardiovascular balloon includes a multi-segment temperature control balloon, a cooling rate control module, a flow control module, a pressure regulation module, an intelligent feedback control module, and a safety protection module.

[0009] The multi-segment temperature control balloon includes a proximal segment temperature control balloon, a middle segment temperature control balloon, a distal segment temperature control balloon, and a heat exchange segment temperature control balloon. Each segment is provided with a cryo-balloon, a micro-refrigerant injection unit, and a temperature sensor, and the cooling rate is independently adjusted.

[0010] The cooling rate control module is connected to each temperature sensor of the multi-segment temperature control balloon, collects sensor data, and calculates the time required for each cryo-balloon to cool down and the refrigerant flow adjustment data.

[0011] The pressure regulation module is connected to the cooling pipeline of each cryo-balloon, collects and monitors the pressure inside the cryo-balloon, and calculates the refrigerant pressure adjustment data.

[0012] The flow control module is connected to each micro-refrigerant injection unit of the multi-segment temperature control balloon, receives the flow adjustment data and the pressure adjustment data, and controls the output parameters of the refrigerant to ensure that the refrigerant accurately enters each temperature control segment according to the set flow rate.

[0013] The intelligent feedback control module is connected to the multi-segment temperature control balloon and the flow control module, and adjusts and sends real-time parameters according to the data collected by each module.

[0014] The safety protection module monitors whether there are abnormal temperature changes or abnormal pressure changes between the cryo-balloon and the cardiovascular tissue. If there are abnormal temperature changes or abnormal pressure changes, an emergency treatment instruction is sent.

[0015] In a preferred embodiment of the present invention, in the above ablation system for a cardiovascular balloon, in the multi-segment temperature control module,

[0016] The cryo-balloon is made of a biocompatible polymer material and is provided with an anti-permeation coating on its outer surface. Each cryo-balloon is connected to the corresponding micro-refrigerant injection unit through a cooling pipeline.

[0017] The micro-refrigerant injection unit includes a micro solenoid valve and a nozzle. Each micro-refrigerant injection unit is connected to a refrigerant delivery device through a cooling pipeline, independently receives the real-time flow rate adjustment signal from the intelligent feedback control module and the refrigerant supply from the refrigerant delivery device, and injects the refrigerant into each corresponding temperature control section.

[0018] The temperature sensor adopts a thin-film type or a micro thermocouple sensor. Each temperature sensor is connected to the cooling rate control module and the intelligent feedback control module through a connecting wire. Each temperature sensor independently collects the real-time temperature of the corresponding temperature control section and transmits it to the cooling rate control module and the intelligent feedback control module.

[0019] Its technical effect is as follows: By separately arranging cryo-balloons, micro-refrigerant injection units and temperature sensors in different temperature control sections, precise temperature control of the cardiovascular balloon is achieved. The temperature sensors in each section independently collect real-time data, dynamically adjust the cooling rate of each section, ensure that the temperature changes in different regions meet the preset targets, and perform differential adjustment according to the temperatures and requirements of different regions, so as to achieve precise control of the freezing rate for the different requirements of each treatment area and avoid cross-influence between different temperature sections.

[0020] In a preferred embodiment of the present invention, in the ablation system for a cardiovascular balloon described above, the cooling rate control module includes:

[0021] A data acquisition unit, including a temperature signal acquisition circuit, a signal conditioning circuit and an analog-to-digital converter, is connected to each independent temperature sensor through multiple temperature signal acquisition circuits to collect the analog signals of the temperature sensors. The signal conditioning circuit processes the analog signals, and the analog-to-digital converter converts the analog signals into digital signals.

[0022] A calculation and processing unit, including a temperature microprocessor, a program memory, a temperature data memory and a clock circuit. The temperature microprocessor reads the digital signals of the temperature data, reads the control algorithm from the program memory, calculates the cooling duration required for each cryo-balloon to reach the target temperature from the current temperature, and calculates the required refrigerant flow rate. The data memory stores operation data and real-time monitoring parameters, provides a storage space for quick access by the microprocessor, and the clock circuit provides a clock signal.

[0023] The output control unit includes a digital-to-analog converter, a signal driving circuit, and an opto-coupler isolation circuit. The digital-to-analog converter converts the digital instructions calculated by the calculation and processing unit into analog signals. The signal driving circuit amplifies the analog signals converted by the digital-to-analog converter to obtain flow adjustment data. The opto-coupler isolation circuit is used for electrical isolation.

[0024] Its technical effects are as follows: Through the multi-channel temperature signal acquisition circuit and temperature sensors, the module can monitor the temperature changes of each cryo-balloon in real time, ensuring the accuracy and timeliness of temperature data; According to the collected temperature data and combined with the control algorithm, accurately calculate the cooling duration and refrigerant flow required for each cryo-balloon to reach the target temperature from the current temperature, ensuring the accuracy of temperature control; According to the flow adjustment data provided by the cooling rate control module, accurately control the output parameters of the refrigerant, ensuring that the refrigerant enters each temperature control section at the set flow rate, improving the cooling efficiency, avoiding waste of refrigerant, and optimizing the resource utilization of the system; By designing an opto-coupler isolation circuit for electrical isolation, ensuring the safety of signal transmission, preventing electrical interference and potential safety risks, and improving the reliability and safety of the system. Especially in medical devices, electrical isolation is an important measure to ensure the safety of patients and devices.

[0025] In a preferred embodiment of the present invention, in the above ablation system for cardiovascular balloons, the pressure regulation module includes:

[0026] A pressure acquisition unit, using a pressure sensor, installed in the cooling pipeline, acquires pressure changes, and converts the collected voltage signal into an electrical signal.

[0027] A pressure adjustment calculation unit, including a pressure microprocessor and a pressure data memory, is connected to the pressure acquisition unit through an interface cable, and calculates pressure adjustment data according to the set pressure range and the treatment target of cryoablation.

[0028] An electrical and signal transmission unit transmits the pressure adjustment data to the flow control module.

[0029] Its technical effects are as follows: By using a pressure sensor to monitor the pressure changes in the cooling pipeline in real time and convert the pressure signal into an electrical signal, it ensures that the system can promptly sense the pressure state inside the cryoballoon, avoiding treatment risks or equipment failures caused by abnormal pressure; According to the set pressure range and the treatment goal of cryoablation, combined with the collected pressure data, accurate pressure adjustment data is calculated, which can ensure that the pressure inside the cryoballoon always remains within a safe and effective range, avoiding the impact of too high or too low pressure on the treatment effect or patient safety; According to the pressure data collected in real time, the pressure parameters of the refrigerant are dynamically adjusted, which can adapt to the possible pressure fluctuations during the treatment process and ensure the stability and continuity of the treatment; The electrical and signal transmission unit transmits the pressure adjustment data to the flow control module to achieve coordinated control of pressure and flow, ensuring that the flow rate and pressure of the refrigerant can match each other, avoiding flow rate out of control or poor refrigeration effect caused by abnormal pressure. By monitoring and precisely controlling the pressure in real time, the pressure adjustment module can effectively prevent the balloon from bursting due to too high pressure inside the cryoballoon or insufficient refrigeration effect due to too low pressure. This safety mechanism significantly reduces the risks during the treatment process and improves the safety and success rate of the operation.

[0030] In a preferred embodiment of the present invention, in the above ablation system for a cardiovascular balloon, the flow control module includes:

[0031] An electrical and signal processing unit, including a digital signal processor, is connected to the cooling rate control module and the pressure adjustment module through an interface circuit, transmits the control signals obtained after processing the flow adjustment data and the pressure adjustment data to the flow adjustment unit, and transmits the monitored flow data back to the cooling rate control module and the pressure adjustment module.

[0032] A flow adjustment unit, using a proportional valve or an electric valve, adjusts the valve opening size according to the control signal obtained by processing the electrical and signal processing unit, adjusts the flow rate of the refrigerant fluid, with the upper end of the valve connected to the cooling pipeline and the lower end connected to the micro refrigerant injection unit.

[0033] A flow monitoring unit, using an electromagnetic flowmeter or a turbine flowmeter, is installed on the cooling pipeline to monitor the flow rate flowing through the cooling pipeline in real time and ensure that the flow rate is within the set range.

[0034] Its technical effects are as follows: By using a proportional valve or an electric valve, the opening degree of the valve can be precisely adjusted according to the control signal provided by the electrical and signal processing unit, thereby controlling the refrigerant flow rate. This precise flow control ensures that the refrigerant can enter each temperature control section according to the set parameters, meeting the cooling requirements of different sections and improving the accuracy of treatment. By using an electromagnetic flowmeter or a turbine flowmeter, the refrigerant flow rate through the cooling pipeline is monitored in real time, abnormal flow can be detected in a timely manner, and the valve opening degree can be adjusted through a feedback mechanism to ensure that the flow rate is always within the set range. By connecting the cooling rate control module and the pressure regulation module through an interface circuit, receiving flow adjustment data and pressure adjustment data, and processing them into control signals and transmitting them to the flow regulation unit, through the synergistic effect, the flow control module can dynamically adjust the refrigerant flow rate according to the changes in temperature and pressure, ensuring that the system is always in the best working state.

[0035] In a preferred embodiment of the present invention, in the ablation system for a cardiovascular balloon described above, the intelligent feedback control module includes:

[0036] A tissue response monitoring unit, using an impedance sensor, including a pair of microelectrode pairs, installed on the surface of the cryoballoon to monitor the impedance change of the cardiovascular tissue, and determining whether the predetermined cryogenic target is reached through the impedance change.

[0037] A machine learning optimization control unit, including an integrated circuit and a memory. The memory stores training data and a cryoablation control model of the tissue response and cryoablation parameters established using machine learning algorithms. The integrated circuit is connected to the flow control module through a data interface, receives the flow adjustment data and the pressure adjustment data, and predicts and adjusts various parameters in the cryoablation process by training the cryoablation control model according to real-time data and historical data.

[0038] A feedback closed-loop control unit, including a signal conditioning circuit, which converts the various parameters generated by the machine learning optimization control unit into real-time flow adjustment signals and sends them to the micro refrigerant injection unit.

[0039] Its technical effects are as follows: By using an impedance sensor and a pair of microelectrodes installed on the surface of the cryoballoon, the impedance change of cardiovascular tissue is monitored in real time, reflecting the freezing state of the tissue (such as whether the tissue is frozen or thawed), so as to determine whether the predetermined freezing target is achieved. This real-time monitoring ability enables the system to dynamically evaluate the treatment effect, avoid over-freezing or under-freezing, and improve the accuracy and safety of the treatment; Through the stored training data and the cryoablation control model established using machine learning algorithms, various parameters during the cryoablation process can be predicted and adjusted based on real-time data and historical data. The machine learning algorithm can learn the relationship between tissue response and cryoablation parameters from a large amount of historical data, optimize the control strategy, and improve the accuracy and adaptability of the treatment; It can dynamically adjust cryoablation parameters (such as refrigerant flow rate, pressure, and cooling rate) according to the data of the tissue response monitoring unit and the machine learning optimization control unit. This dynamic adjustment ability enables the system to quickly respond to changes during the treatment process and ensure the stability and continuity of the treatment; By converting the parameters generated by the machine learning optimization control unit into real-time flow adjustment signals and sending them to the micro-refrigerant injection unit, closed-loop control is achieved, and the treatment parameters can be corrected in real time to ensure that the system always operates towards the predetermined freezing target, improving the accuracy and reliability of the treatment.

[0040] In a preferred embodiment of the present invention, in the above ablation system for a cardiovascular balloon, the safety protection module includes:

[0041] A dual pressure monitoring unit, connected to the pressure regulation module through a cable. When the internal pressure of the cryoballoon exceeds the set range or the pressure at the contact with the tissue is too low, it sends an emergency handling instruction to the pressure regulation module to stop refrigeration or adjust the flow rate and pressure.

[0042] A temperature gradient monitoring unit, which calculates the difference between the temperature inside the cryoballoon and the surface temperature of the cardiovascular tissue and monitors the temperature difference in real time.

[0043] An emergency heating unit, including a heating element and a temperature control processor. The heating element is installed inside the cryoballoon to control the speed of temperature rise. The temperature control processor is connected to the temperature gradient monitoring unit. If it monitors that the temperature difference exceeds the preset safety range, it sends an emergency handling instruction to the heating element to raise the temperature of the cryoballoon back to the preset safety range.

[0044] Its technical effects are as follows: when the internal pressure of the cryoballoon exceeds the set range (which may cause the balloon to rupture) or the pressure at the contact with the tissue is too low (which may cause insufficient cooling effect), the module sends an emergency processing instruction to the pressure regulation module to stop refrigeration or adjust the flow rate and pressure. Through a dual pressure monitoring mechanism, abnormal pressure and abnormal temperature are detected in real time, effectively preventing equipment damage or treatment risks caused by abnormal pressure, and improving the safety and reliability of the system; if the difference exceeds the preset safety range (which may cause tissue damage or poor treatment effect), the module will trigger an emergency processing mechanism to ensure that the temperature change during the cryoablation process is always within the safe range and avoid unnecessary damage to healthy tissues; through the heating element, the speed of temperature rise is precisely controlled to avoid secondary damage to the tissue caused by too fast or too slow temperature recovery, and ensure that the normal state can be restored in a timely manner under abnormal conditions.

[0045] An ablation method for a cardiovascular balloon, which includes:

[0046] Initializing the deployment of a multi-segment temperature-controlled balloon, a cooling rate control module, a flow control module, a pressure regulation module, an intelligent feedback control module, and a safety protection module.

[0047] Obtain the initial temperature T of each segment i,0 , set the low temperature related to the treatment target as the target temperature T i,target , initialize the refrigerant flow rate F of each segment i,0 , initialize the pressure P i,0 .

[0048] In the real-time control stage of the freezing process, the impedance change of the cardiovascular tissue is monitored in real time to judge the freezing effect, and various control parameters in the cryoablation process are predicted and adjusted according to the continuously changing real-time data.

[0049] Monitor whether there is abnormal temperature change or abnormal pressure change between the cryoballoon and the cardiovascular tissue. If there is abnormal temperature change or abnormal pressure change, emergency treatment is carried out.

[0050] In a preferred embodiment of the present invention, in the above ablation method for a cardiovascular balloon, in the real-time control stage of the freezing process, the impedance change of the cardiovascular tissue is monitored in real time to judge the freezing effect, and various control parameters in the cryoablation process are predicted and adjusted according to the continuously changing real-time data, including:

[0051] Read the real-time temperature T of each segment i (t), reflecting the current state of the cryoballoon.

[0052] Through the real-time temperature change Calculate the actual cooling rate v actual .

[0053] Establish an equation describing the relationship between the refrigerant flow rate F i and the cooling rate v i (t), where v i (t) = -α(F i , P i )[T i (t) - T c + β(R i )Q(t), where α(F i , P i ) is the influence coefficient of flow rate and pressure on heat transfer, T c is the refrigerant temperature, R i is the thermal resistance of cardiovascular tissue, and Q(t) is the tissue heat production.

[0054] Compare the actual cooling rate v actual with the desired cooling rate v desired , and adjust the refrigerant flow rate F actual by optimizing the objective function minJ = ∑(v desired (t) - v 2 (t)) i .

[0055] Meanwhile, monitor the pressure P i in each section within the set safety range, where P min ≤ P i ≤ P max .

[0056] Its technical effect is that by real-time monitoring of the impedance change of cardiovascular tissue, precise temperature control, optimization of the objective function, and pressure monitoring, data-driven intelligent control is achieved, improving the treatment accuracy and safety, being able to quickly respond to abnormalities, and significantly enhancing the performance and safety of the cardiovascular balloon ablation method.

[0057] In a preferred embodiment of the present invention, in the ablation system for a cardiovascular balloon, the optimization of the objective function minJ = ∑(v actual (t) - v desired (t)) 2 and adjusting the refrigerant flow rate F i include:

[0058] Calculate the partial derivative of the objective function J with respect to the refrigerant flow rate F i to represent the influence of flow rate on the cooling rate error. Calculate and update the refrigerant flow rate

[0059] where η is the learning rate, used to control the step size of each iterative update.

[0060] ​Its technical effects are as follows: By calculating the partial derivative of the objective function with respect to the refrigerant flow rate, the influence degree of the flow rate on the cooling rate error can be quantified, which helps the system determine the direction and amplitude of the flow rate adjustment in each iteration, so as to more precisely control the cooling rate; By calculating and updating the refrigerant flow rate (including the control of the learning rate), the flow rate can be adaptively adjusted based on real-time feedback, making the adjustment of the refrigerant flow rate smoother and more in line with the actual requirements of the current freezing environment; By gradually optimizing the flow rate adjustment process and precisely controlling the refrigerant flow rate in each section, the consistency and stability of the freezing effect are ensured, avoiding the risks of temperature instability or cooling rate not meeting expectations caused by excessive or insufficient flow rate adjustment; This optimization process does not require manual intervention and can automatically calculate and update the refrigerant flow rate according to real-time data, making the treatment process more intelligent. This flow rate adjustment method based on the optimization of the objective function reduces the complexity of manual operation, improves the automation level of treatment, and reduces the possibility of human errors.

[0061] The beneficial effects of the embodiments of the present invention are:

[0062] The multi-section temperature control design of the present invention can independently control the freezing process of each section, ensuring that the temperature changes and freezing rates in different regions precisely meet the treatment requirements. It avoids the treatment failure or side effects caused by uneven temperature or uneven freezing in the traditional single-section freezing system, and improves the treatment effect and treatment safety. By collecting data in real time through temperature sensors and precisely adjusting the refrigerant flow rate, it ensures that the freezing process can achieve the expected goals in each section.

[0063] Through the integrated intelligent feedback control module, the system can make adaptive adjustments according to data such as real-time temperature, pressure, and impedance changes of cardiovascular tissue. It can dynamically optimize the refrigerant flow rate, pressure, and cooling rate according to the patient's physiological state, freezing effect, and treatment progress to ensure the treatment effect and safety, thereby improving the intelligence and automation level of the system. Different from the traditional system, the present invention can automatically adjust the treatment process according to the actual situation without manual intervention, reducing the operation complexity.

[0064] Through the optimized flow control module and pressure regulation module, the present invention can precisely adjust the refrigerant flow rate and pressure, avoiding the disadvantages of inaccurate flow rate and pressure control in the traditional cryoablation system. The precise adjustment of the flow rate and pressure not only ensures the stability of the freezing process but also effectively avoids over-freezing or local overheating, reducing the risk of adverse reactions in patients. In addition, the combination of the flow control module and the pressure regulation module enables the system to cope with changes in both the flow rate and pressure simultaneously, enhancing the stability and safety of the treatment process.

[0065] Through multiple safety protection mechanisms, such as dual pressure monitoring, temperature gradient monitoring, emergency heating units, etc., the present invention ensures the safety during the treatment process. When abnormal temperature changes or pressure changes occur, the system can automatically trigger emergency protection measures, such as stopping freezing or starting the heating function, to avoid irreversible damage to cardiovascular tissues. It has extremely high reliability and guarantees the safety of patients during the treatment process. BRIEF DESCRIPTION OF THE DRAWINGS

[0066] In order to more clearly illustrate the technical solutions of the embodiments of the present invention, the following will briefly introduce the drawings required for the embodiments. It should be understood that the following drawings only show some embodiments of the present invention, and therefore should not be regarded as limiting the scope. For those of ordinary skill in the art, without creative efforts, other related drawings can also be obtained based on these drawings.

[0067] Figure 1 Structural schematic diagram of the ablation system for a cardiovascular balloon according to the present invention;

[0068] Figure 2 Flowchart of the ablation method for a cardiovascular balloon according to the present invention. DETAILED DESCRIPTION OF THE EMBODIMENTS

[0069] To make the objectives, technical solutions, and advantages of the embodiments of the present invention clearer, the following will clearly and completely describe the technical solutions in the embodiments of the present invention with reference to the drawings in the embodiments of the present invention. Obviously, the described embodiments are some, but not all, of the embodiments of the present invention. Usually, the components of the embodiments of the present invention described and shown in the drawings here can be arranged and designed in various different configurations.

[0070] Please refer to Figure 1, the first embodiment of the present invention provides an ablation system for a cardiovascular balloon, which includes a multi-segment temperature-controlled balloon, a cooling rate control module, a flow control module, a pressure regulation module, an intelligent feedback control module, and a safety protection module; the multi-segment temperature-controlled balloon includes a proximal segment temperature-controlled balloon, a middle segment temperature-controlled balloon, a distal segment temperature-controlled balloon, and a heat exchange segment temperature-controlled balloon. Each segment is provided with a cryogenic balloon, a micro-refrigerant injection unit, and a temperature sensor to independently adjust the cooling rate; the cooling rate control module is connected to each temperature sensor of the multi-segment temperature-controlled balloon, collects sensor data, and calculates the time required for each cryogenic balloon to cool down and the refrigerant flow adjustment data; the pressure regulation module is connected to the cooling pipelines of each cryogenic balloon, collects and monitors the pressure inside the cryogenic balloon, and calculates the refrigerant pressure adjustment data; the flow control module is connected to each micro-refrigerant injection unit of the multi-segment temperature-controlled balloon, receives the flow adjustment data and the pressure adjustment data, and controls the output parameters of the refrigerant to ensure that the refrigerant accurately enters each temperature-controlled segment according to the set flow rate; the intelligent feedback control module is connected to the multi-segment temperature-controlled balloon and the flow control module, adjusts and sends real-time parameters according to the data collected by each module; the safety protection module monitors whether there are abnormal temperature changes or abnormal pressure changes between the cryogenic balloon and the cardiovascular tissue. If abnormal temperature changes or abnormal pressure changes occur, an emergency handling instruction is sent.

[0071] In a preferred embodiment of the present invention, in the above ablation system for a cardiovascular balloon, in the multi-segment temperature control module, the cryogenic balloon is made of a biocompatible polymer material and is provided with an anti-permeation coating on the outer surface. Each cryogenic balloon is connected to the corresponding micro-refrigerant injection unit through a cooling pipeline; the micro-refrigerant injection unit includes a micro solenoid valve and a nozzle. Each micro-refrigerant injection unit is connected to the refrigerant delivery device through a cooling pipeline, independently receives the real-time flow rate adjustment signal of the intelligent feedback control module and the refrigerant supply of the refrigerant delivery device, and sprays the refrigerant into each corresponding temperature-controlled segment; the temperature sensor uses a thin film type or a micro-thermocouple sensor. Each temperature sensor is connected to the cooling rate control module and the intelligent feedback control module through a connecting wire. Each temperature sensor independently collects the real-time temperature of the corresponding temperature-controlled segment and transmits it to the cooling rate control module and the intelligent feedback control module. Adjust the cooling rate of each segment to ensure that the temperature changes in different regions meet the preset targets.

[0072] Its technical effect lies in that by respectively arranging a cryo-balloon, a micro refrigerant injection unit and a temperature sensor in different temperature control sections, precise temperature control of the cardiovascular balloon is achieved. The temperature sensors in each section independently collect real-time data, dynamically adjust the cooling rate of each section, ensure that the temperature changes in different areas meet the preset targets, and perform differential adjustment according to the temperatures and requirements of different areas, so as to achieve precise control of the freezing rate for different requirements of each treatment area and avoid cross-influence between different temperature sections.

[0073] In a preferred embodiment of the present invention, in the ablation system for a cardiovascular balloon, the cooling rate control module includes: a data acquisition unit, including a temperature signal acquisition circuit, a signal conditioning circuit and an analog-to-digital converter. Each independent temperature sensor is connected through a plurality of the temperature signal acquisition circuits to collect the analog signal of the temperature sensor. The signal conditioning circuit processes the analog signal, and the analog-to-digital converter converts the analog signal into a digital signal; a calculation and processing unit, including a temperature microprocessor, a program memory, a temperature data memory and a clock circuit. The temperature microprocessor reads the digital signal of the temperature data, reads the control algorithm from the program memory, calculates the cooling duration required for each cryo-balloon to reach the target temperature from the current temperature, and calculates the required refrigerant flow rate. The data memory stores operation data and real-time monitoring parameters, providing a storage space for rapid access by the microprocessor, and the clock circuit provides a clock signal; an output control unit, including a digital-to-analog converter, a signal driving circuit and an opto-isolation circuit. The digital-to-analog converter converts the digital instruction calculated by the calculation and processing unit into an analog signal. The signal driving circuit amplifies the analog signal converted by the digital-to-analog converter to obtain flow adjustment data, and the opto-isolation circuit is used for electrical isolation.

[0074] During the cooling process, the microprocessor reads the temperature data in real time and calculates the required cooling duration. According to the calculation result, the control signal is converted into an analog quantity through a digital-to-analog converter DAC and drives the flow control module and the pressure regulation module. As time goes by, the refrigerant flow rate and pressure are dynamically adjusted according to the feedback information to ensure that the cryo-balloon always maintains within a predetermined cooling rate range.

[0075] Its technical effects are as follows: Through the multi-channel temperature signal acquisition circuit and temperature sensors, the module can monitor the temperature changes of each cryoballoon in real time, ensuring the accuracy and timeliness of temperature data; According to the acquired temperature data and combined with the control algorithm, it accurately calculates the cooling duration and refrigerant flow rate required for each cryoballoon to reach the target temperature from the current temperature, ensuring the accuracy of temperature control; According to the flow adjustment data provided by the cooling rate control module, it accurately controls the output parameters of the refrigerant, ensuring that the refrigerant enters each temperature control section at the set flow rate, improving the cooling efficiency, avoiding waste of the refrigerant, and optimizing the resource utilization of the system; By designing an optocoupler isolation circuit for electrical isolation, it ensures the safety of signal transmission, prevents electrical interference and potential safety risks, and improves the reliability and safety of the system. Especially in medical devices, electrical isolation is an important measure to ensure the safety of patients and devices.

[0076] In a preferred embodiment of the present invention, in the above ablation system for a cardiovascular balloon, the pressure regulation module includes: a pressure acquisition unit, which uses a pressure sensor installed in the cooling pipeline to acquire pressure changes and convert the acquired voltage signal into an electrical signal; a pressure adjustment calculation unit, including a pressure microprocessor and a pressure data memory, connected to the pressure acquisition unit through an interface cable, and calculates pressure adjustment data according to the set pressure range and the treatment target of cryoablation; an electrical and signal transmission unit that transmits the pressure adjustment data to the flow control module.

[0077] Its technical effects are as follows: By using a pressure sensor to monitor the pressure changes in the cooling pipeline in real time and converting the pressure signal into an electrical signal, it ensures that the system can timely sense the pressure state inside the cryoballoon, avoiding treatment risks or equipment failures caused by abnormal pressure; According to the set pressure range and the treatment target of cryoablation, combined with the acquired pressure data, it calculates accurate pressure adjustment data, ensuring that the pressure inside the cryoballoon always remains within a safe and effective range, avoiding the impact of too high or too low pressure on the treatment effect or patient safety; According to the real-time acquired pressure data, it dynamically adjusts the pressure parameters of the refrigerant, adapting to the possible pressure fluctuations during the treatment process and ensuring the stability and continuity of the treatment; The electrical and signal transmission unit transmits the pressure adjustment data to the flow control module to achieve coordinated control of pressure and flow, ensuring that the flow rate and pressure of the refrigerant can match each other, avoiding flow rate out of control or poor refrigeration effect caused by abnormal pressure. By monitoring and accurately controlling the pressure in real time, the pressure regulation module can effectively prevent the balloon from bursting due to too high pressure inside the cryoballoon or insufficient refrigeration effect caused by too low pressure. This safety mechanism significantly reduces the risks during the treatment process and improves the safety and success rate of the operation.

[0078] In a preferred embodiment of the present invention, in the ablation system for a cardiovascular balloon, the flow control module includes: an electrical and signal processing unit, including a digital signal processor, connected to the cooling rate control module and the pressure regulation module through an interface circuit, transmitting the control signals obtained by processing the flow adjustment data and the pressure adjustment data to the flow regulation unit, and transmitting the monitored flow data back to the cooling rate control module and the pressure regulation module; a flow regulation unit, using a proportional valve or an electric valve, adjusting the valve opening size according to the control signals obtained by processing by the electrical and signal processing unit, regulating the flow rate of the refrigerant fluid, with the upper end of the valve connected to the cooling pipeline and the lower end connected to the micro-refrigerant injection unit; a flow monitoring unit, using an electromagnetic flowmeter or a turbine flowmeter, installed on the cooling pipeline, monitoring the flow rate of the refrigerant flowing through the cooling pipeline in real time to ensure that the flow rate is within the set range.

[0079] The technical effects are as follows: By using a proportional valve or an electric valve, the valve opening size can be precisely adjusted according to the control signals provided by the electrical and signal processing unit, thereby controlling the flow rate of the refrigerant. This precise flow control ensures that the refrigerant can enter each temperature control section according to the set parameters, meeting the cooling requirements of different sections and improving the accuracy of treatment; By using an electromagnetic flowmeter or a turbine flowmeter to monitor the flow rate of the refrigerant flowing through the cooling pipeline in real time, abnormal flow rates can be detected in a timely manner, and the valve opening can be adjusted through a feedback mechanism to ensure that the flow rate is always within the set range; By connecting to the cooling rate control module and the pressure regulation module through an interface circuit, receiving the flow adjustment data and the pressure adjustment data, and processing them into control signals and transmitting them to the flow regulation unit, through the synergistic effect, the flow control module can dynamically adjust the refrigerant flow rate according to the changes in temperature and pressure to ensure that the system is always in the best working state.

[0080] In a preferred embodiment of the present invention, in the ablation system for a cardiovascular balloon, the intelligent feedback control module includes: a tissue response monitoring unit, using an impedance sensor, including a pair of microelectrode pairs, installed on the surface of the cryoballoon, monitoring the impedance change of the cardiovascular tissue, and judging whether the predetermined cryo-target is reached through the impedance change; a machine learning optimization control unit, including an integrated circuit and a memory, the memory storing training data and a cryoablation control model of the tissue response and cryoablation parameters established using machine learning algorithms, the integrated circuit being connected to the flow control module through a data interface, receiving the flow adjustment data and the pressure adjustment data, and predicting and adjusting various parameters in the cryoablation process by training the cryoablation control model according to real-time data and historical data; a feedback closed-loop control unit, including a signal conditioning circuit, converting the various parameters generated by the machine learning optimization control unit into real-time flow adjustment signals and sending them to the micro-refrigerant injection unit.

[0081] Its technical effects are as follows: By adopting an impedance sensor and a pair of microelectrodes installed on the surface of the cryoballoon, it can monitor the impedance change of cardiovascular tissue in real time, reflect the freezing state of the tissue (such as whether the tissue is frozen or thawed), so as to judge whether the predetermined freezing target is achieved. This real-time monitoring ability enables the system to dynamically evaluate the treatment effect, avoid over-freezing or under-freezing, and improve the accuracy and safety of the treatment; Through the stored training data and the cryoablation control model established using machine learning algorithms, it can predict and adjust various parameters during the cryoablation process based on real-time data and historical data. The machine learning algorithm can learn the relationship between tissue response and cryoablation parameters from a large amount of historical data, optimize the control strategy, and improve the accuracy and adaptability of the treatment; It can dynamically adjust the cryoablation parameters (such as refrigerant flow rate, pressure, and cooling rate) according to the data of the tissue response monitoring unit and the machine learning optimization control unit. This dynamic adjustment ability enables the system to quickly respond to changes during the treatment process and ensure the stability and continuity of the treatment; By converting the parameters generated by the machine learning optimization control unit into real-time flow regulation signals and sending them to the micro refrigerant injection unit, closed-loop control is achieved, and the treatment parameters can be corrected in real time to ensure that the system always operates towards the predetermined freezing target, improving the accuracy and reliability of the treatment.

[0082] In a preferred embodiment of the present invention, in the ablation system for a cardiovascular balloon, the safety protection module includes: a dual pressure monitoring unit, connected to the pressure regulation module through a cable, and when the internal pressure of the cryoballoon exceeds the set range or the pressure at the contact with the tissue is too low, it sends an emergency processing instruction to the pressure regulation module to stop refrigeration or adjust the flow rate and pressure; a temperature gradient monitoring unit, calculating the difference between the temperature inside the cryoballoon and the surface temperature of the cardiovascular tissue, and monitoring the temperature difference in real time; an emergency heating unit, including a heating element and a temperature control processor, the heating element is installed inside the cryoballoon to control the speed of temperature rise, and the temperature control processor is connected to the temperature gradient monitoring unit. If the monitored temperature difference exceeds the preset safety range, it sends an emergency processing instruction to the heating element to raise the temperature of the cryoballoon back to the preset safety range.

[0083] Its technical effects are as follows: When the internal pressure of the cryoballoon exceeds the set range (which may cause the balloon to rupture) or the pressure at the contact with the tissue is too low (which may cause insufficient cooling effect), the module sends an emergency processing instruction to the pressure regulation module to stop refrigeration or adjust the flow rate and pressure. Through a dual pressure monitoring mechanism, it can detect pressure abnormalities and temperature abnormalities in real time, effectively prevent equipment damage or treatment risks caused by pressure abnormalities, and improve the safety and reliability of the system; if the difference exceeds the preset safety range (which may cause tissue damage or poor treatment effect), the module will trigger an emergency processing mechanism to ensure that the temperature change during the cryoablation process is always within the safe range and avoid unnecessary damage to healthy tissues; through the heating element, it can precisely control the speed of temperature rise, avoid secondary damage to the tissue caused by too fast or too slow temperature recovery, and ensure that it can return to the normal state in a timely manner under abnormal conditions.

[0084] Please refer to Figure 2 , the second embodiment of the present invention provides an ablation method for a cardiovascular balloon, which includes: initializing the deployment of a multi-segment temperature-controlled balloon, a cooling rate control module, a flow rate control module, a pressure regulation module, an intelligent feedback control module, and a safety protection module; obtaining the initial temperature T of each segment i,0 , setting the low temperature related to the treatment target as the target temperature T i,target , initializing the refrigerant flow rate F of each segment i,0 , ensuring the temperature control in the initial state, initializing the pressure P i,0 , ensuring that the system is in a safe working state; in the real-time control stage of the freezing process, it monitors the impedance change of the cardiovascular tissue in real time to judge the freezing effect, and predicts and adjusts various control parameters in the cryoablation process according to the continuously changing real-time data; monitors whether there are abnormal temperature changes or abnormal pressure changes between the cryoballoon and the cardiovascular tissue, and if there are abnormal temperature changes or abnormal pressure changes, emergency treatment is carried out.

[0085] In a preferred embodiment of the present invention, in the above ablation method for a cardiovascular balloon, in the real-time control stage of the freezing process, monitoring the impedance change of the cardiovascular tissue in real time to judge the freezing effect and predicting and adjusting various control parameters in the cryoablation process according to the continuously changing real-time data includes: reading the real-time temperature T of each segment i (t), which reflects the current state of the cryoballoon; calculating the actual cooling rate v through the real-time temperature change ; establishing a relationship equation v actual describing the refrigerant flow rate F i and the cooling rate v i (t) as v i (t) = -α(F i , P i )[T i (t) - Tc + β(R i )Q(t), where α(F i , P i ) is the influence coefficient of flow rate and pressure on heat transfer, T c is the refrigerant temperature, R i is the thermal resistance of cardiovascular tissue, and Q(t) is the tissue heat production; compare the actual cooling rate v actual and the desired cooling rate v desired , and adjust the refrigerant flow rate F actual (t) - v desired (t)) 2 by optimizing the objective function minJ = ∑(v i ; at the same time, monitor the pressure P i of each section within the set safety range, P min ≤ P i ≤ P max .

[0086] Its technical effect is that by real-time monitoring the impedance change of cardiovascular tissue, precisely controlling the temperature, optimizing the objective function, and monitoring the pressure, data-driven intelligent control is achieved, improving the treatment accuracy and safety, being able to quickly respond to abnormalities, and significantly enhancing the performance and safety of the cardiovascular balloon ablation method.

[0087] In a preferred embodiment of the present invention, in the ablation system for a cardiovascular balloon, the optimization objective function minJ = ∑(v actual (t) - v desired (t)) 2 , and adjusting the refrigerant flow rate F i includes: calculating the partial derivative of the objective function J with respect to the refrigerant flow rate F i to represent the influence of the flow rate on the cooling rate error; calculating and updating the refrigerant flow rate where η is the learning rate, used to control the step size of each iterative update.

[0088] Its technical effects are as follows: By calculating the partial derivative of the objective function with respect to the refrigerant flow rate, the influence degree of the flow rate on the cooling rate error can be quantified, which helps the system determine the direction and amplitude of the flow rate adjustment in each iteration, thereby more precisely controlling the cooling rate; By calculating and updating the refrigerant flow rate (including the control of the learning rate), the flow rate can be adaptively adjusted based on real-time feedback, making the adjustment of the refrigerant flow rate smoother and more in line with the actual requirements of the current freezing environment; By gradually optimizing the flow rate adjustment process and precisely controlling the refrigerant flow rate in each section, the consistency and stability of the freezing effect are ensured, avoiding the risks of temperature instability or cooling rate not meeting expectations caused by excessive or insufficient flow rate adjustment; This optimization process does not require manual intervention and can automatically calculate and update the refrigerant flow rate according to real-time data, making the treatment process more intelligent. This flow rate adjustment method based on the optimization of the objective function reduces the complexity of manual operations, improves the automation level of the treatment, and reduces the possibility of human errors.

[0089] The computer program product of the ablation method and device for a cardiovascular balloon provided by the embodiment of the present invention includes a computer-readable storage medium storing program codes. The instructions included in the program codes can be used to execute the methods in the foregoing method embodiments. For specific implementation, reference can be made to the method embodiments and will not be elaborated herein.

[0090] Specifically, the storage medium can be a general storage medium, such as a removable disk, a hard disk, etc. When the computer program on the storage medium runs, it can execute the foregoing ablation method for a cardiovascular balloon, thereby achieving multi-section independent temperature control, precise cooling rate control, intelligent feedback adjustment, and high safety.

[0091] If the described functions are implemented in the form of software function units and sold or used as independent products, they can be stored in a non-volatile computer-readable storage medium executable by a processor. Based on such an understanding, the technical solution of the present invention, in essence, or the part that contributes to the prior art or a part of this technical solution can be embodied in the form of a software product. This computer software product is stored in a storage medium and includes several instructions for causing a computer device (which can be a personal computer, a server, or a network device, etc.) to execute all or part of the steps of the methods described in various embodiments of the present invention. The foregoing storage medium includes: various media such as USB flash drives, mobile hard disks, read-only memories (ROMs), random access memories (RAMs), magnetic disks, or optical discs that can store program codes.

[0092] Finally, it should be noted that the above-described embodiments are only specific embodiments of the present invention, which are used to illustrate the technical solutions of the present invention, rather than to limit it. The protection scope of the present invention is not limited thereto. Although the present invention has been described in detail with reference to the foregoing embodiments, those of ordinary skill in the art should understand that any technician familiar with the technical field of the present invention can still modify the technical solutions described in the foregoing embodiments, or can easily think of changes, or make equivalent replacements for some of the technical features; and these modifications, changes or replacements do not cause the essence of the corresponding technical solutions to deviate from the spirit and scope of the technical solutions of the embodiments of the present invention, and should all be covered by the protection scope of the present invention. Therefore, the protection scope of the present invention shall be subject to the protection scope of the claims.

Claims

1. A cryoablation system for cardiovascular balloon, characterized in that: It includes a multi-section temperature control balloon, a cooling rate control module, a flow control module, a pressure regulation module, an intelligent feedback control module and a safety protection module; The multi-segment temperature-controlled balloon includes a proximal segment temperature-controlled balloon, a middle segment temperature-controlled balloon, a distal segment temperature-controlled balloon, and a heat exchange segment temperature-controlled balloon. Each segment is provided with a freezing balloon, a micro-refrigerant injection unit, and a temperature sensor to independently adjust the cooling rate. The cooling rate control module is connected to each temperature sensor of the multi-segment temperature control balloon, collects sensor data, and calculates the time required for cooling each of the freezing balloons and the flow adjustment data of the refrigerant; The pressure regulating module is connected to the cooling pipe of each of the cryoballoons, collects and monitors the pressure inside the cryoballoons, and calculates the pressure adjustment data of the refrigerant; The flow control module is connected to each of the micro refrigerant injection units of the multi-section temperature control balloon, receives the flow adjustment data and the pressure adjustment data, controls the output parameters of the refrigerant, and ensures that the refrigerant accurately enters each temperature control section at a set flow rate; The intelligent feedback control module is connected to the multi-section temperature control balloon and the flow control module, and adjusts and sends real-time parameters according to the data collected by each module; The safety protection module monitors whether there is abnormal temperature change or abnormal pressure change between the cryoballoon and the cardiovascular tissue, and sends an emergency processing instruction if abnormal temperature change or abnormal pressure change occurs.

2. The cryoablation system for cardiovascular balloon according to claim 1, characterized in that: In the multi-zone temperature control module, The cryoballoon is made of biocompatible polymer material and has an anti-permeability coating on the surface. Each cryoballoon is connected to the corresponding micro-refrigerant injection unit through a cooling pipe. The micro refrigerant injection unit includes a micro solenoid valve and a nozzle. Each of the micro refrigerant injection units is connected to a refrigerant delivery device through a cooling pipeline, and independently receives a real-time flow adjustment signal from the intelligent feedback control module and a refrigerant supply from the refrigerant delivery device, and injects the refrigerant into each corresponding temperature control section. The temperature sensor adopts a thin film type or a micro thermocouple sensor. Each of the temperature sensors is connected to the cooling rate control module and the intelligent feedback control module through a connecting line. Each of the temperature sensors independently collects the real-time temperature of the corresponding temperature control section and transmits it to the cooling rate control module and the intelligent feedback control module.

3. The cryoablation system for cardiovascular balloon according to claim 1, characterized in that: The cooling rate control module comprises: A data acquisition unit, comprising a temperature signal acquisition circuit, a signal conditioning circuit and an analog-to-digital converter, wherein each independent temperature sensor is connected via multiple temperature signal acquisition circuits to acquire analog signals from the temperature sensors, the signal conditioning circuit processes the analog signals, and the analog-to-digital converter converts the analog signals into digital signals; A computing and processing unit, comprising a temperature microprocessor, a program memory, a temperature data memory and a clock circuit, wherein the temperature microprocessor reads a digital signal of temperature data, reads a control algorithm from the program memory, calculates the cooling time required for each cryoballoon from the current temperature to the target temperature, and calculates the required refrigerant flow rate, the data memory stores operating data and real-time monitoring parameters, and provides a storage space for fast access for the microprocessor, and the clock circuit provides a clock signal; The output control unit includes a digital-to-analog converter, a signal driving circuit and an optocoupler isolation circuit. The digital-to-analog converter converts the digital instructions calculated by the calculation processing unit into analog signals. The signal driving circuit amplifies the analog signals converted by the digital-to-analog converter to obtain flow adjustment data. The optocoupler isolation circuit is used for electrical isolation.

4. The cryoablation system for cardiovascular balloon according to claim 2, characterized in that: The pressure regulating module comprises: A pressure collection unit, using a pressure sensor, is installed in the cooling pipe to collect pressure changes and convert the collected voltage signal into an electrical signal; A pressure adjustment calculation unit, including a pressure microprocessor and a pressure data storage device, is connected to the pressure acquisition unit via an interface cable, and calculates pressure adjustment data according to a set pressure range and a treatment target of cryoablation; The electrical and signal transmission unit transmits the pressure adjustment data to the flow control module.

5. The cryoablation system for cardiovascular balloon according to claim 2, characterized in that: The flow control module comprises: An electrical and signal processing unit, including a digital signal processor, connected to the cooling rate control module and the pressure regulating module through an interface circuit, transmitting a control signal obtained after processing the flow adjustment data and the pressure adjustment data to the flow regulating unit, and transmitting the monitored flow data back to the cooling rate control module and the pressure regulating module; The flow regulating unit adopts a proportional valve or an electric valve, and adjusts the valve opening size and the flow rate of the refrigerant fluid according to the control signal processed by the electrical and signal processing unit. The upper end of the valve is connected to the cooling pipeline, and the lower end is connected to the micro refrigerant injection unit; The flow monitoring unit adopts an electromagnetic flowmeter or a turbine flowmeter, which is installed on the cooling pipeline to monitor the flow through the cooling pipeline in real time to ensure that the flow is within a set range.

6. The cryoablation system for cardiovascular balloon according to claim 1, characterized in that: The intelligent feedback control module comprises: The tissue reaction monitoring unit adopts an impedance sensor, including a pair of micro-electrode pairs, which are installed on the surface of the cryoballoon to monitor the impedance change of cardiovascular tissue and judge whether the predetermined freezing target is achieved through the impedance change; A machine learning optimization control unit, comprising an integrated circuit and a memory, wherein the memory stores training data and a cryoablation control model of tissue reaction and cryoablation parameters established using a machine learning algorithm, wherein the integrated circuit is connected to the flow control module via a data interface, receives the flow adjustment data and the pressure adjustment data, and predicts and adjusts various parameters in the cryoablation process by training the cryoablation control model based on real-time data and historical data; A feedback closed-loop control unit includes a signal conditioning circuit, which converts various parameters generated by the machine learning optimization control unit into real-time flow regulation signals and sends them to the micro refrigerant injection unit.

7. The cryoablation system for cardiovascular balloon according to claim 1, characterized in that: The security protection module comprises: A dual pressure monitoring unit is connected to the pressure regulating module via a cable, and when the internal pressure of the cryoballoon exceeds a set range or the pressure at the contact point with the tissue is too low, an emergency processing instruction is sent to the pressure regulating module to stop refrigeration or adjust the flow and pressure; A temperature gradient monitoring unit, which calculates the difference between the temperature inside the cryoballoon and the temperature on the surface of the cardiovascular tissue, and monitors the temperature difference in real time; The emergency heating unit includes a heating element and a temperature control processor. The heating element is installed in the cryoballoon to control the rate of temperature rise. The temperature control processor is connected to the temperature gradient monitoring unit. If the temperature difference detected exceeds a preset safety range, an emergency processing instruction is sent to the heating element to raise the temperature of the cryoballoon back to the preset safety range.

8. A method for cardiovascular balloon ablation, characterized in that: include: Initialize the deployment of the multi-zone temperature control balloon, cooling rate control module, flow control module, pressure regulation module, intelligent feedback control module and safety protection module; Get the initial temperature T of each section i,0 , set the low temperature associated with the treatment goal as the target temperature T i,target , initialize the refrigerant flow F of each section i,0 , initialize pressure P i,0 ; During the real-time control stage of the freezing process, the impedance changes of cardiovascular tissues are monitored in real time to determine the freezing effect, and various control parameters during the cryoablation process are predicted and adjusted based on the constantly changing real-time data; Monitor whether there are abnormal temperature changes or abnormal pressure changes between the cryoballoon and the cardiovascular tissue, and if abnormal temperature changes or abnormal pressure changes occur, perform emergency treatment.

9. The cardiovascular balloon ablation method according to claim 8, characterized in that: In the real-time control stage of the freezing process, the impedance changes of cardiovascular tissues are monitored in real time to determine the freezing effect, and the various control parameters of the cryoablation process are predicted and adjusted according to the constantly changing real-time data, including: Read the real-time temperature T of each zone i (t), reflects the current state of the cryoballoon; Real-time temperature changes Calculate the actual cooling rate v actual ; Establish a description of the refrigerant flow F i and cooling rate v i (t) relationship equation v i (t) = -α(F i ,P i )[T i (t)-T c ]+β(R i )Q(t), where α(F i ,P i ) is the influence coefficient of flow rate and pressure on heat transfer, T c is the refrigerant temperature, R i is the thermal resistance of cardiovascular tissue, Q(t) is the tissue heat production; Compare the actual cooling rate v actual and the expected cooling rate v desired , by optimizing the objective function minJ = ∑(v actual (t)-v desired (t)) 2 , adjust the refrigerant flow F i ; Simultaneously monitor the pressure P of each section i Within the set safety range, P min ≤P i ≤P max .

10. The cardiovascular balloon ablation method according to claim 9, characterized in that: The optimization objective function minJ=∑(v actual (t)-v desired (t)) 2 , adjust the refrigerant flow F i include: Calculate the objective function J for the refrigerant flow rate F i The partial derivative of Used to indicate the effect of flow rate on the error of cooling rate; Calculate and update refrigerant flow Among them, η is the learning rate, which is used to control the step size of each iterative update.

Images