Ablation electrode temperature control method and temperature control system

Abstract

This invention relates to the field of medical ablation technology, and discloses a method and system for controlling the temperature of an ablation electrode. The method includes: during the ablation process, acquiring in real time the output power of the ablation host and the biological tissue impedance between the ablation electrode and the lesion tissue monitored by the ablation host; calculating the real-time heat generation power of the ablation electrode acting on the lesion tissue; acquiring the inlet temperature, outlet temperature, and instantaneous flow rate of the cooling medium flowing through the internal cooling channel of the ablation electrode, and quantifying the real-time heat dissipation power of the cooling medium according to the heat transfer relationship of the medium; determining thermal state parameters based on the real-time difference between the real-time heat generation power and the real-time heat dissipation power, the thermal state parameters reflecting the heat accumulation trend; dynamically adjusting the flow rate of the cooling medium using a feedforward method; and in the feedforward dynamic adjustment, collecting and associating successful ablation parameter combinations of biological tissue to construct a self-learning parameter library for the ablation electrode. This invention can improve the accuracy of ablation electrode temperature control.

Description

Technical Field

[0001] This invention relates to the field of medical ablation technology, and in particular to a method and system for controlling the temperature of an ablation electrode. Background Technology

[0002] Existing technologies have significant shortcomings in the sensing and quantification of heat dissipation for ablation electrode temperature control. They fail to calculate real-time heat generation power based on the dynamic coupling relationship between output electrical power and biological tissue impedance, relying solely on estimations using fixed power parameters, making it difficult to accurately capture the dynamic changes in heat power during ablation. Furthermore, they fail to simultaneously acquire and quantify the real-time heat dissipation power of the cooling medium's inlet and outlet temperatures and instantaneous flow rate, using only fixed flow rate control for heat dissipation. This lack of dynamic adaptation to actual heat dissipation conditions leads to inaccuracies in the assessment of the electrode's thermal balance.

[0003] Existing technologies have significant shortcomings in the regulation logic and optimization mechanism of ablation electrode temperature control. They fail to perform feedforward dynamic adjustment based on the ablation stage and thermal state parameters, relying solely on feedback regulation or fixed rules to adjust the cooling medium flow rate. This makes it difficult to anticipate heat accumulation trends, resulting in insufficient timeliness and accuracy in temperature control. Furthermore, they lack a self-learning parameter library that associates successfully ablated parameter combinations, relying only on preset adjustment strategies. This makes it impossible to optimize the initial adjustment plan for different types of lesions, leading to unstable temperature control efficiency and compromising ablation efficacy and surgical safety. Summary of the Invention

[0004] This invention provides a method and system for controlling the temperature of an ablation electrode to solve the problems mentioned in the background art.

[0005] To achieve the above objectives, the present invention provides a method for controlling the temperature of an ablation electrode, comprising: S1. During the ablation process, the output power of the ablation host and the bio-tissue impedance between the ablation electrode and the lesion tissue monitored by the ablation host are acquired in real time. S2. Based on the dynamic coupling relationship between the output electrical power and the biological tissue impedance, the real-time heat generation power of the ablation electrode acting on the lesion tissue is calculated using a heat power conversion algorithm. S3. Simultaneously acquire the inlet temperature, outlet temperature and instantaneous flow rate of the cooling medium flowing through the internal cooling channel of the ablation electrode, and quantify the real-time heat dissipation power of the cooling medium according to the heat transfer relationship of the medium. S4. Determine the thermal state parameters of the ablation electrode based on the real-time difference between the real-time heat generation power and the real-time heat dissipation power. The thermal state parameters reflect the heat accumulation trend of the ablation electrode. S5. Based on the stage of the ablation process and the thermal state parameters, the flow rate of the cooling medium is dynamically adjusted in a feedforward manner. S6. In the feedforward dynamic adjustment, successful ablation parameter combinations of biological tissues are collected and correlated to construct a self-learning parameter library for the ablation electrode.

[0006] In a preferred embodiment, the step of acquiring the output power of the ablation host and the bio-tissue impedance between the ablation electrode and the lesion tissue monitored by the ablation host in real time during the ablation process includes: At the same time as the ablation host starts outputting radio frequency energy, a synchronous trigger signal for the ablation host is generated; Based on the synchronous trigger signal, the acquisition of voltage and current waveforms at the output terminal of the ablation host, as well as the acquisition of excitation signals applied to the ablation electrodes and response signals from the lesion tissue are synchronously triggered. The acquired voltage and current waveforms are subjected to signal conditioning and high-speed digital conversion to obtain the output power of the ablation host. The acquired excitation and response signals are conditioned and digitally converted at high speed to obtain the bio-tissue impedance of the ablation host.

[0007] In a preferred embodiment, the step of calculating the real-time heat generation power of the ablation electrode acting on the lesion tissue based on the dynamic coupling relationship between the output electrical power and the biological tissue impedance using a thermal power conversion algorithm includes: The difference between the current biological tissue impedance and the biological tissue impedance at the previous sampling time is evaluated to obtain the instantaneous change in the biological tissue impedance. Based on the instantaneous change and the output electrical power, the instantaneous electrothermal conversion factor of the ablation electrode is constructed; The real-time heat generation power acting on the lesion tissue is calculated based on the instantaneous electrothermal conversion factor and the output electrical power.

[0008] In a preferred embodiment, the formula for calculating the real-time heat generation power is: ; In the formula, The real-time heat generation power, For the current moment Real-time acquisition of biological tissue impedance, These are constants derived from the principle of energy conservation and the inherent electrothermal properties of the ablation electrode. For the instantaneous change, For the current moment The output electrical power is acquired in real time.

[0009] In a preferred embodiment, the step of simultaneously acquiring the inlet temperature, outlet temperature, and instantaneous flow rate of the cooling medium flowing through the internal cooling channel of the ablation electrode, and quantifying the real-time heat dissipation power of the cooling medium based on the heat transfer relationship of the medium, includes: The inlet temperature is obtained by a first temperature sensor installed at the inlet of the cooling channel, and the outlet temperature is obtained by a second temperature sensor installed at the outlet of the cooling channel. The instantaneous flow rate of the cooling medium is obtained by a flow meter on the cooling channel; The temperature change of the cooling medium as it flows through the ablation electrode is obtained by performing a difference calculation between the inlet temperature and the outlet temperature. Based on the specific heat capacity and density parameters of the cooling medium, the temperature change value is fused to obtain the intermediate heat capacity parameter of the cooling medium. The real-time heat dissipation power of the cooling medium is obtained by jointly calculating the intermediate heat capacity parameter and the instantaneous flow rate.

[0010] In a preferred embodiment, determining the thermal state parameters of the ablation electrode based on the real-time difference between the real-time heat generation power and the real-time heat dissipation power, wherein the thermal state parameters reflect the heat accumulation trend of the ablation electrode, includes: The difference between the real-time heat generation power and the real-time heat dissipation power is compared to obtain the real-time difference of the cooling medium. Based on the continuous change direction and rate of change of the real-time difference, the instantaneous thermodynamic stage of the ablation electrode is determined, and the stage identification signal corresponding to the instantaneous thermodynamic stage is output. The current stage of the ablation process is obtained, and the stage identifier signal is correlated with the stage of the ablation process to obtain the fusion thermal state identifier of the ablation electrode. Based on the fusion thermal state identifier, thermal state parameters of the ablation electrode are generated, and the thermal state parameters reflect the thermal accumulation trend of the ablation electrode.

[0011] In a preferred embodiment, determining the instantaneous thermodynamic stage of the ablation electrode based on the continuous change direction and rate of change of the real-time difference, and outputting the stage identification signal corresponding to the instantaneous thermodynamic stage, includes: The continuous change direction of the real-time difference is identified, including: positive direction, negative direction or stable direction close to zero, and the rate of change of the real-time difference is identified simultaneously, including: high-speed change, medium-speed change or low-speed change. Based on the direction of continuous change and the rate of change, the instantaneous thermodynamic stage of the ablation electrode is determined, wherein... When the direction of continuous change is positive and the rate of change is high speed, it is determined that the ablation electrode is in the stage of rapid heat accumulation. When the direction of continuous change is positive and the rate of change is medium or low, it is determined that the ablation electrode is in a stable heat accumulation stage. When the direction of continuous change is a stable direction, the ablation electrode is determined to be in the thermal equilibrium stage; When the direction of continuous change is negative, the ablation electrode is determined to be in the heat dissipation stage. Output the stage identifier signal corresponding to the determined instantaneous thermodynamic stage.

[0012] In a preferred embodiment, the step of dynamically adjusting the flow rate of the cooling medium based on the stage of the ablation process and the thermal state parameters includes: The thermal state parameters and the stage identification signal are combined and encoded to obtain the combined control index of the ablation electrode; The combined control index is mapped to the historical feedforward regulation rule base of the ablation electrode to obtain the target flow regulation command of the cooling medium. The historical feedforward regulation rule base stores the flow regulation strategies corresponding to different operation stages and different combinations of thermal state parameters. According to the target flow rate adjustment command, the flow control terminal connected to the cooling channel is driven to perform the adjustment action on the flow rate of the cooling medium.

[0013] In a preferred embodiment, the step of collecting and correlating successful ablation parameter combinations of biological tissues in the feedforward dynamic adjustment to construct a self-learning parameter library for the ablation electrode includes: During the feedforward dynamic adjustment execution, a set of ablation process parameters, including the output electrical power, the biological tissue impedance, the thermal state parameters, and the corresponding cooling medium flow rate adjustment command, are collected in real time. The system monitors characteristic signals that indicate expected changes in the morphology and electrophysiological properties of lesion tissue under the action of the ablation electrode. When a characteristic signal representing successful ablation is detected, the ablation process parameter set at the current time and the adjacent time period is marked as an effective parameter combination. The parameters in the effective parameter combination are synchronously correlated to form an empirical mapping relationship with the biological tissue impedance and the thermal state parameters as inputs and the optimized cooling medium flow rate adjustment command as output. Based on the lesion tissue type corresponding to the effective parameter combination, the empirical mapping relationship is stored in the structured knowledge base of the ablation electrode to obtain the self-learning parameter library of the ablation electrode. When a new ablation procedure is initiated for the same type of lesion tissue, an initial cooling medium flow rate adjustment strategy is matched and recommended from the self-learning parameter library based on the initially acquired biological tissue impedance.

[0014] To address the above problems, the present invention also provides an ablation electrode temperature control system, the system comprising: The dynamic monitoring module is used to acquire the output power of the ablation host and the bio-tissue impedance between the ablation electrode and the lesion tissue monitored by the ablation host in real time during the ablation process. The thermal power calculation module is used to calculate the real-time heat generation power of the ablation electrode acting on the lesion tissue based on the dynamic coupling relationship between the output electrical power and the impedance of the biological tissue through a thermal power conversion algorithm. The heat dissipation analysis module is used to simultaneously acquire the inlet temperature, outlet temperature and instantaneous flow rate of the cooling medium flowing through the internal cooling channel of the ablation electrode, and quantify the real-time heat dissipation power of the cooling medium according to the heat transfer relationship of the medium. The thermal state assessment module is used to determine the thermal state parameters of the ablation electrode based on the real-time difference between the real-time heat generation power and the real-time heat dissipation power. The thermal state parameters reflect the heat accumulation trend of the ablation electrode. The feedforward control module is used to dynamically adjust the flow rate of the cooling medium based on the stage of the ablation process and the thermal state parameters. The self-learning optimization module is used to collect and correlate successful ablation parameter combinations of biological tissues in feedforward dynamic adjustment to construct a self-learning parameter library for the ablation electrode.

[0015] Compared with the prior art, the present invention has the following beneficial effects: 1. This invention provides scientific data support for ablation electrode temperature control through precise thermal power calculation and heat dissipation analysis. It collects real-time data on the output electrical power of the ablation host and the impedance of biological tissue, and accurately calculates the real-time heat generation power based on their dynamic coupling relationship and thermal power conversion algorithm. Simultaneously, it acquires the inlet temperature, outlet temperature, and instantaneous flow rate of the cooling medium, quantifying the real-time heat dissipation power through the medium's heat transfer relationship. This comprehensive understanding of the electrode's heat balance provides a precise basis for temperature regulation.

[0016] 2. This invention significantly improves the accuracy and stability of ablation electrode temperature control through intelligent adjustment and self-learning optimization. Based on the ablation stage and thermal state parameters, it dynamically adjusts the cooling medium flow rate via feedforward to match the heat accumulation trend in real time. Simultaneously, it collects parameter combinations from successful ablation procedures, constructs a self-learning parameter library, and provides optimized initial flow rate adjustment strategies for ablation of similar lesions, continuously improving temperature control efficiency and ablation effect, ensuring surgical safety and efficacy. Attached Figure Description

[0017] Figure 1 This is a schematic flowchart of an ablation electrode temperature control method according to an embodiment of the present invention; Figure 2 A functional block diagram of an ablation electrode temperature control system provided in an embodiment of the present invention; Figure 3 This is a schematic diagram of the real-time heat generation and heat dissipation calculation principle provided in an embodiment of the present invention; Figure 4 This is a schematic diagram illustrating the mechanism of feedforward dynamic adjustment and self-learning parameter library construction provided in an embodiment of the present invention; The realization of the objective, functional features and advantages of the present invention will be further explained in conjunction with the embodiments and with reference to the accompanying drawings. Detailed Implementation

[0018] It should be understood that the specific embodiments described herein are merely illustrative of the invention and are not intended to limit the invention.

[0019] This application provides a method for controlling the temperature of an ablation electrode. The execution subject of this ablation electrode temperature control method includes, but is not limited to, at least one of the following electronic devices that can be configured to execute the method provided in this application: a server, a terminal, etc. In other words, the ablation electrode temperature control method can be executed by software or hardware installed on a terminal device or a server device. The server includes, but is not limited to, a single server, a server cluster, a cloud server, or a cloud server cluster. The server can be an independent server or a cloud server that provides basic cloud computing services such as cloud services, cloud databases, cloud computing, cloud functions, cloud storage, network services, cloud communication, middleware services, domain name services, security services, content delivery networks (CDNs), and big data and artificial intelligence platforms.

[0020] Reference Figure 1 The diagram shown is a flowchart illustrating a method for controlling the temperature of an ablation electrode according to an embodiment of the present invention. In this embodiment, the method for controlling the temperature of an ablation electrode includes: S1. During the ablation process, the output power of the ablation host and the bio-tissue impedance between the ablation electrode and the lesion tissue monitored by the ablation host are acquired in real time. In this embodiment of the invention, the step of acquiring the output power of the ablation host and the bio-tissue impedance between the ablation electrode and the lesion tissue monitored by the ablation host in real time during the ablation process includes: At the same time as the ablation host starts outputting radio frequency energy, a synchronous trigger signal for the ablation host is generated; Based on the synchronous trigger signal, the acquisition of voltage and current waveforms at the output terminal of the ablation host, as well as the acquisition of excitation signals applied to the ablation electrodes and response signals from the lesion tissue are synchronously triggered. The acquired voltage and current waveforms are subjected to signal conditioning and high-speed digital conversion to obtain the output power of the ablation host. The acquired excitation and response signals are conditioned and digitally converted at high speed to obtain the bio-tissue impedance of the ablation host.

[0021] The moment the ablation host starts outputting radio frequency energy, the internal signal triggering unit of the system starts working synchronously, directly generating an electrical signal that is completely synchronized with the radio frequency energy output action as the synchronous trigger signal of the ablation host. This trigger signal will serve as the time reference for all subsequent signal acquisition actions, ensuring that the acquisition operations of each stage maintain strict timing consistency with the radio frequency energy output.

[0022] Based on the generated synchronous trigger signal, the signal acquisition unit simultaneously starts the operation of two acquisition channels. One acquisition channel is precisely connected to the energy output end of the ablation host to continuously acquire the voltage and current waveforms output in real time at that port. The other acquisition channel is connected to the signal transmission end of the ablation electrode to synchronously acquire the excitation signal applied to the ablation electrode for ablation, as well as the response signal fed back by the lesion tissue after receiving the excitation signal, thus realizing differential timing acquisition of the two types of signals.

[0023] The acquired voltage and current waveforms are subjected to signal conditioning. The signal amplification process is used to improve the recognizability of weak waveform signals, and the filtering process is used to remove electromagnetic interference and environmental noise mixed in the waveforms to ensure the purity of the voltage and current waveforms. After conditioning, the analog voltage and current waveforms are transmitted to the digital conversion unit to convert them into digital electrical signal data. Based on this digital signal data, the real-time output power of the ablation host is directly determined.

[0024] Signal conditioning is performed on the acquired excitation and response signals. Signal shaping corrects waveform distortion during signal transmission, and impedance matching eliminates impedance interference in the signal transmission link, ensuring the integrity of the excitation and response signals. After conditioning, the analog excitation and response signals are sent to the digital conversion unit to be converted into digital signal data. Based on this digital signal data, the bio-tissue impedance between the ablation electrode and the lesion tissue monitored by the ablation host is directly determined. For example, when ablating liver lesions, the bio-tissue impedance signal between the ablation electrode and the liver tissue can be accurately acquired and converted in this way. When ablating myocardial lesions, the corresponding bio-tissue impedance can also be acquired and converted simultaneously.

[0025] The beneficial effect is that the synchronous trigger signal enables strict timing synchronization between radio frequency energy output and signal acquisition, ensuring that the output power and biological tissue impedance data correspond accurately in the time dimension, laying a reliable foundation for subsequent parameter coupling calculations.

[0026] Based on this signal, two types of core signals are acquired simultaneously, enabling differential timing acquisition of the electrical parameters of the ablation host and the electrode-tissue impedance signal, ensuring that the data can truly reflect the equipment and tissue status at the same ablation moment.

[0027] The acquired signals are conditioned and digitally converted to effectively eliminate electromagnetic interference and correct waveform distortion, so that the values ​​of output power and biological tissue impedance are accurately consistent with reality, and truly reflect the equipment output status and lesion tissue impedance changes during the ablation process.

[0028] The system achieves real-time, synchronous, and accurate acquisition of two types of core parameters, providing high-quality basic data for subsequent calculation of real-time heat generation power based on dynamic coupling relationship. At the same time, it eliminates the need to add additional acquisition components to the ablation electrode, which meets the requirements of refined electrode design and avoids the failure risk of external components, thus improving the overall stability and reliability of the system.

[0029] S2. Based on the dynamic coupling relationship between the output electrical power and the biological tissue impedance, the real-time heat generation power of the ablation electrode acting on the lesion tissue is calculated using a heat power conversion algorithm. In this embodiment of the invention, the step of calculating the real-time heat generation power of the ablation electrode acting on the lesion tissue based on the dynamic coupling relationship between the output electrical power and the biological tissue impedance using a thermal power conversion algorithm includes: The difference between the current biological tissue impedance and the biological tissue impedance at the previous sampling time is evaluated to obtain the instantaneous change in the biological tissue impedance. Based on the instantaneous change and the output electrical power, the instantaneous electrothermal conversion factor of the ablation electrode is constructed; The real-time heat generation power acting on the lesion tissue is calculated based on the instantaneous electrothermal conversion factor and the output electrical power.

[0030] The formula for calculating the real-time heat generation power is: ; In the formula, The real-time heat generation power, For the current moment Real-time acquisition of biological tissue impedance, These are constants derived from the principle of energy conservation and the inherent electrothermal properties of the ablation electrode. For the instantaneous change, For the current moment The output electrical power is acquired in real time.

[0031] This method extracts all characterization information of biological tissue impedance acquired at the current moment and biological tissue impedance acquired at the previous sampling moment during the ablation process. It comprehensively evaluates the differences between the two sets of impedance information, and determines the trend and degree of impedance change by comparing the impedance characterization states of the two. It directly obtains the instantaneous change in biological tissue impedance that can accurately reflect the real-time changes in lesion tissue impedance during the ablation process. For example, when ablating liver lesions, this method can be used to obtain the instantaneous change in liver tissue impedance caused by radiofrequency action during the ablation process. When ablating myocardial lesions, the instantaneous change in myocardial tissue impedance can also be obtained simultaneously.

[0032] Using the instantaneous change in biological tissue impedance as the core reference, combined with the real-time output power of the ablation host, and based on the energy interaction law between the ablation electrode and the lesion tissue, the dynamic change in tissue impedance reflected by the instantaneous change is coupled with the energy output state of the output power. By matching the dynamic interaction relationship between the two, an instantaneous electrothermal conversion factor of the ablation electrode that can accurately reflect the energy conversion efficiency of the ablation electrode under the current tissue state is constructed. This factor can be adjusted in real time with the dynamic changes in tissue impedance and output power to ensure a high degree of consistency with the actual energy conversion state of the ablation process.

[0033] The instantaneous electrothermal conversion factor of the constructed ablation electrode is correlated with the real-time output power of the ablation host for energy conversion calculation. Based on the instantaneous electrothermal conversion factor, the effective energy conversion ratio of the output power to the lesion tissue is determined. Combined with the real-time energy output value of the output power, the actual power of the ablation electrode acting on the lesion tissue and generating heat at the current moment through radiofrequency energy is accurately calculated. Finally, the real-time heat generation power acting on the lesion tissue that can truly reflect the heat generation state of the lesion tissue during the ablation process is obtained.

[0034] Real-time heat generation power is the actual power of heat generated by the ablation electrode acting on the lesion tissue. This value is derived from the coupling of multiple parameters collected and calculated in real time during the ablation process, and is a direct characterization of the energy conversion state of the ablation electrode to the lesion tissue.

[0035] The real-time biological tissue impedance acquired at the current moment is the value obtained by the ablation host synchronously collecting the excitation signal applied to the ablation electrode and the response signal from the lesion tissue at the current moment of radiofrequency energy output. After signal conditioning and high-speed digital conversion, it directly reflects the actual impedance state between the ablation electrode and the lesion tissue at the current moment.

[0036] The constant is a fixed value determined based on the principle of energy conservation, combined with the inherent electrothermal properties of the ablation electrode such as material and structure, and after multiple experimental verifications. This value does not change with the changes of various parameters during the ablation process.

[0037] Instantaneous change is a comprehensive assessment of the difference between the current biological tissue impedance and the biological tissue impedance at the previous sampling time. The value obtained by comparing the impedance states of the two directly reflects the dynamic change of biological tissue impedance between two adjacent sampling times.

[0038] The real-time output power obtained at the current moment is the value obtained by synchronously collecting the voltage and current waveforms at the output end of the ablation host at the current moment of radio frequency energy output, and after signal conditioning and high-speed digital conversion. It directly reflects the actual state of radio frequency energy output of the ablation host at the current moment.

[0039] This calculation method uses the output electrical power obtained in real time during the ablation process as the core energy basis, combines the current biological tissue impedance and the instantaneous change in impedance at adjacent sampling times, and incorporates constants related to the inherent properties of the ablation electrode to achieve accurate calculation of the real-time heat generation power of the ablation electrode acting on the lesion tissue.

[0040] By introducing the ratio of the biological tissue impedance at the previous sampling time to the current time, it is possible to adapt to the influence of the basic state of lesion tissue impedance on the electrothermal conversion process of the ablation electrode, so that the calculation of heat generation power is consistent with the actual impedance characteristics of the current lesion tissue and adapts to the basic differences in tissue impedance during the ablation process.

[0041] By combining a constant with the ratio of the instantaneous change to the biological tissue impedance at the previous sampling time to form a correction factor, the impact of the dynamic change in lesion tissue impedance on the electrothermal conversion efficiency of the ablation electrode can be accurately quantified. This overcomes the limitations of relying solely on fixed power to calculate heat generation and adapts to the actual situation where the lesion tissue impedance continuously changes with the action of radiofrequency energy during the ablation process.

[0042] The overall calculation logic organically combines the output power, the dynamic impedance of the lesion tissue, and the inherent electrothermal properties of the ablation electrode. This allows the calculated real-time heat generation power to accurately and dynamically reflect the actual state of the heat energy released by the ablation electrode to the lesion tissue at the current moment. This provides core and accurate heat generation data support for subsequent real-time calculation of the heat dissipation carried away by the cooling medium of the ablation electrode and accurate estimation of the overall thermal state of the ablation electrode.

[0043] Based on the thermal state estimation performed using this real-time heat generation power, the system can detect the temperature change trend of the ablation electrode in advance, thereby providing data basis for dynamically adjusting the flow rate of the cooling medium in the circulation pipeline and realizing predictive control of the ablation electrode temperature. This fundamentally solves the problem of lag in traditional temperature measurement and adjustment. At the same time, this calculation logic can be adapted to the ablation process of different types of lesions such as liver, lung, and myocardium, ensuring the accuracy and adaptability of heat generation power calculation during the ablation of different tissues, and laying a data foundation for accurate and real-time control of the ablation electrode temperature.

[0044] The beneficial effect is that by assessing the biological tissue impedance at adjacent time points, the dynamic changes in the impedance of the lesion tissue during the ablation process can be accurately captured. The real-time changes obtained truly reflect the changes in tissue characteristics under radiofrequency action, providing a basis for the subsequent construction of electrothermal conversion factors that fits the actual working conditions, and making up for the deficiency that impedance at a single time point cannot reflect the dynamic changes of tissue.

[0045] An instantaneous electrothermal conversion factor is constructed based on the instantaneous change in impedance and the output power to achieve dynamic coupling between electrothermal conversion efficiency and tissue dynamic impedance and host output power. This factor can be adjusted in real time with the ablation parameters to accurately match the actual electrothermal conversion law under different tissue states and different power levels, avoiding calculation deviations caused by fixed conversion coefficients.

[0046] The real-time heat generation power is calculated based on the instantaneous electrothermal conversion factor and the output power. The output power is accurately corrected by the dynamic conversion factor, so that the calculation results truly reflect the actual heat generation state of the ablation electrode acting on the lesion tissue. The heat generation power of different ablation stages and different tissue types is accurately quantified, providing core and accurate heat generation data support for subsequent evaluation of electrode thermal state and adjustment of cooling medium flow rate.

[0047] The overall calculation process realizes the dynamic correlation between output power and biological tissue impedance, breaking through the limitations of traditional fixed power estimation of heat generation. It adapts to the actual situation of continuous changes in tissue impedance during ablation and can accurately adapt to the heat generation calculation needs of different lesions such as liver, myocardium, and lung. It lays a precise data foundation for the prediction of electrode thermal state and the feedforward adjustment of cooling medium, thereby improving the scientificity and accuracy of ablation electrode temperature control from the source.

[0048] This calculation formula enables the quantitative calculation of the dynamic coupling between output electrical power and biological tissue impedance, allowing the calculation of real-time heat generation power to accurately match the actual working conditions of the ablation process, thus breaking through the limitations of traditional fixed power estimation of heat generation.

[0049] The formula incorporates the ratio of biological tissue impedance at the current time to that at the previous sampling time, adapting to the influence of the baseline state of lesion tissue impedance on electrothermal conversion, making the calculation closely match the inherent impedance characteristics of different tissues; combined with the correction factor formed by the constant and the instantaneous change in impedance, it accurately quantifies the impact of dynamic changes in tissue impedance during ablation on electrothermal conversion efficiency, making up for the deviation of single parameter calculation.

[0050] At the same time, the constant of the inherent electrothermal properties of the ablation electrode is incorporated, so that the calculation takes into account the energy conversion characteristics of the device itself. This achieves an organic combination of device properties, output power, and tissue dynamic impedance, so that the real-time heat generation power can truly and dynamically reflect the actual heat generation state of the ablation electrode acting on the lesion tissue.

[0051] The quantitative calculation logic of this formula provides core and accurate heat generation data support for subsequent precise calculation of heat dissipation power, evaluation of electrode thermal state, and feedforward adjustment of cooling medium flow rate. It can be adapted to the heat generation calculation of ablation of different types of lesions such as liver, myocardium, and lung, and improves the scientificity, accuracy and adaptability of ablation electrode temperature control from the data level.

[0052] S3. Simultaneously acquire the inlet temperature, outlet temperature and instantaneous flow rate of the cooling medium flowing through the internal cooling channel of the ablation electrode, and quantify the real-time heat dissipation power of the cooling medium according to the heat transfer relationship of the medium. In this embodiment of the invention, the step of simultaneously acquiring the inlet temperature, outlet temperature, and instantaneous flow rate of the cooling medium flowing through the internal cooling channel of the ablation electrode, and quantifying the real-time heat dissipation power of the cooling medium based on the heat transfer relationship of the medium, includes: The inlet temperature is obtained by a first temperature sensor installed at the inlet of the cooling channel, and the outlet temperature is obtained by a second temperature sensor installed at the outlet of the cooling channel. The instantaneous flow rate of the cooling medium is obtained by a flow meter on the cooling channel; The temperature change of the cooling medium as it flows through the ablation electrode is obtained by performing a difference calculation between the inlet temperature and the outlet temperature. Based on the specific heat capacity and density parameters of the cooling medium, the temperature change value is fused to obtain the intermediate heat capacity parameter of the cooling medium. The real-time heat dissipation power of the cooling medium is obtained by jointly calculating the intermediate heat capacity parameter and the instantaneous flow rate.

[0053] A first temperature sensor is fixedly installed at the inlet of the cooling channel inside the ablation electrode. This sensor is precisely fitted to the inlet end of the cooling channel and directly captures the real-time temperature of the cooling medium flowing through the inlet, continuously and stably obtaining the inlet temperature of the cooling medium. A second temperature sensor is fixedly installed at the outlet of the cooling channel. This sensor is precisely fitted to the outlet end of the cooling channel and directly captures the real-time temperature of the cooling medium flowing through the outlet, continuously and stably obtaining the outlet temperature of the cooling medium. For example, when ablating myocardial tissue, this method can be used to simultaneously obtain the real-time temperature of the cooling medium entering and exiting the cooling channel of the ablation electrode.

[0054] A flow meter is connected in series in the cooling channel of the ablation electrode. The detection end of the flow meter is in direct contact with the cooling medium inside the cooling channel, capturing the flow state of the cooling medium in the channel in real time. Based on the flow rate of the cooling medium and the channel diameter, the instantaneous flow rate of the cooling medium flowing through the cooling channel at the current moment can be directly obtained, ensuring that the acquisition of flow data and temperature data are synchronized in time. For example, when ablating liver tissue, the instantaneous flow value of physiological saline as the cooling medium can be accurately obtained through this flow meter.

[0055] The outlet temperature and inlet temperature of the cooling medium are collected in real time and the difference is calculated. The outlet temperature is used as a reference and the inlet temperature is subtracted to directly obtain the temperature change value of the cooling medium as it flows through the internal cooling channel of the ablation electrode due to the absorption of heat generated by the ablation electrode. That is, the temperature change value of the cooling medium when it flows through the ablation electrode. This value directly reflects the actual state of the cooling medium absorbing heat from the ablation electrode.

[0056] The inherent specific heat capacity and density parameters of the cooling medium are extracted. These parameters are inherent physical properties of the cooling medium and do not change with the operating conditions of the ablation process. The inherent parameters are characteristically fused with the temperature change value when the cooling medium flows through the ablation electrode. The degree of heat absorption reflected by the temperature change value is coupled with the inherent thermophysical properties of the cooling medium to form a comprehensive parameter that can characterize the heat absorption capacity of the cooling medium per unit volume, namely the intermediate heat capacity parameter of the cooling medium. For example, when sterile water is used as the cooling medium, its inherent specific heat capacity, density and actual temperature change value are directly fused to obtain the corresponding intermediate heat capacity parameter.

[0057] The intermediate heat capacity parameter of the cooling medium is jointly calculated with the real-time instantaneous flow rate. The heat absorption capacity of the cooling medium per unit volume, represented by the intermediate heat capacity parameter, is coupled with the volume of the cooling medium flowing through the cooling channel per unit time, represented by the instantaneous flow rate. Through the correlation calculation between the two, the amount of heat absorbed and carried away by the cooling medium from the ablation electrode per unit time is directly quantified, and the real-time heat dissipation power of the cooling medium is finally obtained. This value directly reflects the real-time heat dissipation capacity of the cooling medium on the ablation electrode.

[0058] The beneficial effects are that, through dedicated temperature sensors at the inlet and outlet of the flow channel and pipeline flow meters, the inlet temperature, outlet temperature and instantaneous flow of the cooling medium can be collected synchronously and accurately. The data acquisition and ablation process are linked in real time, which can truly reflect the actual flow and heat exchange state of the cooling medium, and provide accurate basic monitoring data for the quantification of heat dissipation power.

[0059] By performing differential calculations on the inlet and outlet temperatures, the actual temperature change of the cooling medium after flowing through the electrode is directly obtained, accurately characterizing the actual degree to which the cooling medium absorbs heat from the electrode, laying a core basis for subsequent calculation of heat dissipation power in conjunction with the properties of the medium.

[0060] By integrating the inherent specific heat capacity and density of the cooling medium with the actual temperature change value, the intermediate heat capacity parameter is obtained. By fully combining the thermophysical properties of the medium itself with the actual heat transfer changes, the actual heat absorption capacity of the cooling medium per unit volume is accurately quantified, so that the heat dissipation power calculation fits the actual heat transfer characteristics of the cooling medium.

[0061] By jointly calculating the intermediate heat capacity parameter and the instantaneous flow rate, and coupling the heat absorption capacity per unit volume with the medium flow rate per unit time, the heat absorbed and carried away by the cooling medium from the electrode per unit time is accurately quantified. The resulting real-time heat dissipation power can truly reflect the actual heat dissipation state of the electrode and form an accurate heat balance data match with the real-time heat generation power.

[0062] The overall process achieves accurate and dynamic quantification of the real-time heat dissipation power of the cooling medium, can synchronously match the heat generation changes of the ablation electrode, and fully grasp the heat balance of the electrode. This provides accurate heat dissipation data support for subsequent determination of the electrode thermal state and realization of feedforward dynamic adjustment of the cooling medium flow rate, effectively making up for the shortcomings of traditional fixed flow control heat dissipation that cannot adapt to actual heat exchange conditions.

[0063] S4. Determine the thermal state parameters of the ablation electrode based on the real-time difference between the real-time heat generation power and the real-time heat dissipation power. The thermal state parameters reflect the heat accumulation trend of the ablation electrode. In this embodiment of the invention, determining the thermal state parameters of the ablation electrode based on the real-time difference between the real-time heat generation power and the real-time heat dissipation power, wherein the thermal state parameters reflect the heat accumulation trend of the ablation electrode, includes: The difference between the real-time heat generation power and the real-time heat dissipation power is compared to obtain the real-time difference of the cooling medium. Based on the continuous change direction and rate of change of the real-time difference, the instantaneous thermodynamic stage of the ablation electrode is determined, and the stage identification signal corresponding to the instantaneous thermodynamic stage is output. The current stage of the ablation process is obtained, and the stage identifier signal is correlated with the stage of the ablation process to obtain the fusion thermal state identifier of the ablation electrode. Based on the fusion thermal state identifier, thermal state parameters of the ablation electrode are generated, and the thermal state parameters reflect the thermal accumulation trend of the ablation electrode.

[0064] The determination of the instantaneous thermodynamic stage of the ablation electrode based on the continuous change direction and rate of change of the real-time difference, and the output of the stage identification signal corresponding to the instantaneous thermodynamic stage, includes: The continuous change direction of the real-time difference is identified, including: positive direction, negative direction or stable direction close to zero, and the rate of change of the real-time difference is identified simultaneously, including: high-speed change, medium-speed change or low-speed change. Based on the direction of continuous change and the rate of change, the instantaneous thermodynamic stage of the ablation electrode is determined, wherein... When the direction of continuous change is positive and the rate of change is high speed, it is determined that the ablation electrode is in the stage of rapid heat accumulation. When the direction of continuous change is positive and the rate of change is medium or low, it is determined that the ablation electrode is in a stable heat accumulation stage. When the direction of continuous change is a stable direction, the ablation electrode is determined to be in the thermal equilibrium stage; When the direction of continuous change is negative, the ablation electrode is determined to be in the heat dissipation stage. Output the stage identifier signal corresponding to the determined instantaneous thermodynamic stage.

[0065] The real-time heat generation power of the ablation electrode applied to the lesion tissue is directly compared with the real-time heat dissipation power of the cooling medium. The real-time heat generation power is used as a benchmark, and the real-time heat dissipation power is subtracted to obtain a real-time difference value that can accurately reflect the difference in energy values ​​between the two. The sign and magnitude of this value directly reflect the current balance between heat generation and dissipation of the ablation electrode. For example, when the real-time heat generation power is greater than the real-time heat dissipation power during myocardial tissue ablation, the real-time difference value is positive, and when the real-time heat dissipation power is greater than the real-time heat generation power during liver tissue ablation, the real-time difference value is negative.

[0066] The system continuously tracks and monitors the changes in the real-time difference during the ablation process, accurately capturing the continuous direction and rate of change of the real-time difference per unit time. Combining the basic laws of thermodynamics, the system determines the instantaneous thermodynamic stage of the ablation electrode based on the combination of the direction and rate of change. This stage includes the heat accumulation stage, the heat equilibrium stage, and the heat dissipation stage. After the determination is completed, the system directly outputs a stage identifier signal that uniquely corresponds to the instantaneous thermodynamic stage. This signal is a standardized electrical signal that can accurately characterize the current instantaneous thermodynamic state of the ablation electrode.

[0067] The system's built-in ablation process stage identification unit accurately obtains the current stage of the ablation process based on information such as the duration of radio frequency energy output and the nodes of the ablation operation process. This stage includes the pre-cooling stage before ablation, the initial heating stage of ablation, the stabilization stage of ablation, and the cooling stage of ablation. The system performs a comprehensive feature matching between the real-time output stage identification signal and the current stage of the ablation process to verify the fit between the instantaneous thermodynamic stage and the ablation process stage. After the matching is completed, a fusion thermal state identifier that can simultaneously reflect the ablation process stage and the instantaneous thermal state of the electrode is generated.

[0068] Based on the fusion thermal state indicator, and combined with the inherent thermophysical properties of the ablation electrode, such as the material specific heat capacity and structural thermal conductivity, the thermal change trend of the ablation electrode is quantitatively characterized. The system directly generates thermal state parameters that can accurately reflect the thermal accumulation trend of the ablation electrode. These parameters can clearly show whether the ablation electrode continues to accumulate heat, maintains thermal balance, or gradually dissipates heat. For example, when the fusion thermal state indicator reflects the initial heating stage of ablation and the electrode is in the heat accumulation stage, the generated thermal state parameters will accurately characterize the trend of continuous and rapid heat accumulation of the electrode. When the fusion thermal state indicator reflects the stable stage of mid-ablation and the electrode is in the thermal balance stage, the generated thermal state parameters will accurately characterize the trend of no significant heat accumulation and dynamic balance of the electrode.

[0069] The system continuously monitors and identifies the changes in the real-time difference during ablation. By comparing the real-time difference values ​​at adjacent sampling times, the overall direction of change of the real-time difference is determined. If the real-time difference continues to increase, it is determined to be in a positive direction; if the real-time difference continues to decrease, it is determined to be in a negative direction; if the real-time difference value fluctuates almost no, it is determined to be in a stable direction close to zero. While identifying the direction of change, the system also identifies the rate of change of the real-time difference based on the magnitude of the change in the real-time difference value per unit time. A large magnitude of change is determined to be a high-speed change; a medium magnitude of change is determined to be a medium-speed change; and a small magnitude of change is determined to be a low-speed change. For example, in the early stage of myocardial tissue ablation, the real-time heat generation power is rapidly higher than the heat dissipation power, and the real-time difference will show a positive direction and a high-speed change. In the middle stage of ablation, when heat generation and heat dissipation tend to stabilize, the real-time difference will show a stable direction and a low-speed change.

[0070] The direction and rate of change of the identified real-time difference are combined and matched to accurately determine the current thermodynamic state of the ablation electrode according to the preset judgment rules. When the direction of change is positive and the rate of change is high, the ablation electrode is determined to be in the rapid heat accumulation stage. When the direction of change is positive and the rate of change is medium or low, the ablation electrode is determined to be in the stable heat accumulation stage. When the direction of change is a stable direction close to zero, the ablation electrode is determined to be in the thermal equilibrium stage regardless of the type of change rate. When the direction of change is negative, the ablation electrode is determined to be in the heat dissipation stage regardless of the type of change rate. For example, when the radiofrequency energy output decreases at the end of liver tissue ablation and the real-time heat generation power is less than the heat dissipation power, and the real-time difference is negative, the electrode is directly determined to be in the heat dissipation stage.

[0071] The system internally assigns a unique standardized stage identifier signal to each instantaneous thermodynamic stage. This signal is an electrical signal that can be recognized and transmitted by the system. After determining the instantaneous thermodynamic stage of the ablation electrode, the system directly retrieves the stage identifier signal that matches the determined stage and outputs it. The output stage identifier signal can accurately and uniquely characterize the instantaneous thermodynamic stage that the ablation electrode is currently in, providing a clear and standardized signal basis for subsequent fusion ablation process stage information and generation of thermal state parameters. For example, when the electrode is determined to be in the rapid heat accumulation stage, the corresponding exclusive stage identifier signal is output; when the electrode is determined to be in the thermal equilibrium stage, another corresponding exclusive stage identifier signal is output.

[0072] The beneficial effect is that by comparing the difference between the real-time heat generation power and the heat dissipation power, the real-time difference that reflects the heat balance of the electrode can be accurately obtained, which intuitively reflects the numerical difference between heat generation and loss, and provides a core quantitative basis for subsequent thermal state determination.

[0073] By combining the direction and rate of change of the real-time difference to determine the instantaneous thermodynamic stage and outputting an identification signal, it can accurately identify different thermal states of the electrode, such as rapid accumulation of heat, stable accumulation, thermal equilibrium, and heat dissipation, so that the instantaneous thermodynamic state of the electrode can be standardized and clearly characterized.

[0074] By matching the instantaneous thermodynamic stage identifier signal with the actual stage of the ablation process to form a fusion thermal state identifier, a dual combination of the instantaneous thermal state of the electrode and the ablation process stage is achieved, avoiding the one-sidedness of a single dimension judgment and making the thermal state identification more consistent with the actual ablation working conditions.

[0075] Based on the fusion thermal state identifier, thermal state parameters can be generated to accurately quantify and reflect the thermal accumulation trend of the electrode, clearly showing the subsequent heat change trend of the electrode. This provides a precise and realistic thermal state basis for the feedforward adjustment of the subsequent cooling medium flow rate, allowing temperature control to match the electrode thermal accumulation trend in advance. This fundamentally solves the problem of lag in traditional temperature control, while improving the scientificity and accuracy of electrode thermal state assessment, laying a key foundation for the precise control of ablation electrode temperature.

[0076] By simultaneously identifying the continuous direction and rate of change of the real-time difference, precise monitoring of the thermal balance of the ablation electrode is achieved in two dimensions. This allows for both understanding the overall trend of the thermal difference and controlling the rate of change, thus comprehensively and meticulously capturing the dynamic characteristics of the electrode's thermal state.

[0077] Based on the combination rules of direction and rate, the instantaneous thermodynamic stage is standardized and clearly divided into four stages: rapid heat accumulation, steady accumulation, thermal equilibrium, and heat dissipation. This makes the determination of the electrode thermal state clear and standardized, avoids the bias of subjective judgment, and accurately matches the actual thermodynamic state of the electrode during the ablation process.

[0078] It configures and outputs exclusive stage identification signals for different instantaneous thermodynamic stages, transforming the electrode thermal state into a standardized signal that the system can identify and transmit. This provides a unified and clear signal basis for subsequent matching with ablation process stages and generating thermal state parameters, ensuring smooth connection of subsequent thermal state assessment stages.

[0079] The system achieves accurate, objective, and standardized determination and signal output of the instantaneous thermodynamic stage of the ablation electrode, enabling the system to quickly and accurately sense changes in the electrode's thermal state. This provides a key basis for determining the thermal state for subsequent feedforward dynamic adjustment of the cooling medium flow rate, ensuring the timeliness and accuracy of temperature control from a fundamental level and effectively avoiding the problem of improper control caused by ambiguity in thermal state determination.

[0080] S5. Based on the stage of the ablation process and the thermal state parameters, the flow rate of the cooling medium is dynamically adjusted in a feedforward manner. In this embodiment of the invention, the step of dynamically adjusting the flow rate of the cooling medium based on the stage of the ablation process and the thermal state parameters includes: The thermal state parameters and the stage identification signal are combined and encoded to obtain the combined control index of the ablation electrode; The combined control index is mapped to the historical feedforward regulation rule base of the ablation electrode to obtain the target flow regulation command of the cooling medium. The historical feedforward regulation rule base stores the flow regulation strategies corresponding to different operation stages and different combinations of thermal state parameters. According to the target flow rate adjustment command, the flow control terminal connected to the cooling channel is driven to perform the adjustment action on the flow rate of the cooling medium.

[0081] All feature information of the thermal state parameters and stage identification signals of the melting electrode is extracted. The two types of information are composite encoded according to the system's preset encoding rules. The thermal accumulation trend characteristics reflected by the thermal state parameters and the instantaneous thermodynamic stage characteristics represented by the stage identification signals are deeply integrated and transformed into standardized encoding information that the system can recognize. Finally, a combined control index that can simultaneously reflect the electrode's thermal accumulation trend and instantaneous thermodynamic stage is obtained. For example, when the thermal state parameters represent rapid heat accumulation and the stage identification signal is the rapid heat accumulation stage, a corresponding exclusive combined control index will be generated. When the thermal state parameters represent heat balance and the stage identification signal is the heat balance stage, another set of exclusive combined control indexes will be generated.

[0082] The system pre-builds a historical feedforward regulation rule base for ablation electrodes. Based on a large amount of ablation experimental and clinical application data, this rule base stores all flow regulation strategies corresponding to different operation stages and different combinations of thermal state parameters in the ablation process. Each combination control index has a unique corresponding flow regulation strategy in the rule base. The generated combination control index is directly mapped to this historical feedforward regulation rule base. The corresponding flow regulation strategy is quickly retrieved through index matching and converted into a standardized instruction that the system can execute. Finally, the target flow regulation instruction for the cooling medium is obtained. This instruction clearly includes core control information such as the direction and magnitude of flow adjustment of the cooling medium. For example, for the rapid heat accumulation stage of myocardial tissue ablation, the mapping will result in a target flow regulation instruction to increase the flow of the cooling medium.

[0083] The generated target flow rate adjustment command for the cooling medium is transmitted in real time to the flow control terminal connected to the cooling channel of the ablation electrode. This flow control terminal is an execution device that directly controls the flow of the cooling medium. It can complete the corresponding flow rate adjustment action according to the received command. After receiving the target flow rate adjustment command, the flow control terminal will precisely drive the internal flow control component to operate according to the adjustment direction and adjustment range specified in the command, so as to realize the real-time adjustment of the cooling medium flow rate. For example, when receiving the command to increase the flow rate, the flow control terminal will drive the valve to open wider or the pump to speed up to increase the flow rate of the cooling medium. When receiving the command to stabilize the flow rate, it will maintain the current operating state of the flow control component to ensure that the cooling medium flow rate is compatible with the thermal state and ablation stage of the ablation electrode.

[0084] The beneficial effect is that by combining the thermal state parameters and stage identification signals to obtain a combined control index, the characteristics of electrode heat accumulation trend and instantaneous thermodynamic stage are integrated to form a standardized control basis that the system can identify, making the flow regulation command matching more accurate and avoiding the one-sidedness of single parameter control.

[0085] By mapping the combined control index to the historical feedforward regulation rule library, and relying on the flow regulation strategies corresponding to different operation stages and thermal state parameter combinations stored in the library, the target flow regulation command can be quickly matched and generated, so that the flow regulation strategy fits the actual ablation working conditions, improving the efficiency and adaptability of command generation.

[0086] The flow control terminal is driven to perform adjustment actions according to the target flow adjustment command, so as to achieve precise and real-time control of the cooling medium flow. This allows the flow change to be highly adapted to the ablation stage and the electrode thermal state. By using feedforward adjustment, the trend of electrode heat accumulation can be dealt with in advance, fundamentally solving the lag problem of traditional feedback adjustment.

[0087] The system achieves intelligent feedforward dynamic adjustment of the cooling medium flow rate, allowing the flow rate control to precisely match the thermal state changes throughout the ablation process. This effectively stabilizes the temperature of the ablation electrode, preventing tissue thermal damage caused by overheating or insufficient temperature from affecting the ablation effect. At the same time, it improves the timeliness and accuracy of ablation electrode temperature control, ensuring the safety and efficacy of the ablation procedure.

[0088] S6. In the feedforward dynamic adjustment, successful ablation parameter combinations of biological tissues are collected and correlated to construct a self-learning parameter library for the ablation electrode.

[0089] In this embodiment of the invention, the step of collecting and correlating successful ablation parameter combinations of biological tissues in the feedforward dynamic adjustment to construct a self-learning parameter library for the ablation electrode includes: During the feedforward dynamic adjustment execution, a set of ablation process parameters, including the output electrical power, the biological tissue impedance, the thermal state parameters, and the corresponding cooling medium flow rate adjustment command, are collected in real time. The system monitors characteristic signals that indicate expected changes in the morphology and electrophysiological properties of lesion tissue under the action of the ablation electrode. When a characteristic signal representing successful ablation is detected, the ablation process parameter set at the current time and the adjacent time period is marked as an effective parameter combination. The parameters in the effective parameter combination are synchronously correlated to form an empirical mapping relationship with the biological tissue impedance and the thermal state parameters as inputs and the optimized cooling medium flow rate adjustment command as output. Based on the lesion tissue type corresponding to the effective parameter combination, the empirical mapping relationship is stored in the structured knowledge base of the ablation electrode to obtain the self-learning parameter library of the ablation electrode. When a new ablation procedure is initiated for the same type of lesion tissue, an initial cooling medium flow rate adjustment strategy is matched and recommended from the self-learning parameter library based on the initially acquired biological tissue impedance.

[0090] Throughout the entire process of performing feedforward dynamic adjustment of the cooling medium flow rate, the system continuously and synchronously collects various core operating parameters during the ablation process. It integrates and collects the output power of the ablation host, the biological tissue impedance between the ablation electrode and the lesion tissue, the thermal state parameters reflecting the trend of electrode heat accumulation, and the cooling medium flow rate adjustment commands issued at the corresponding time, forming an ablation process parameter set containing multi-dimensional ablation operation information. This ensures that the collected parameters are accurately corresponding in the time dimension, with no information gaps or misalignments. For example, when performing ablation on myocardial tissue, the system will collect the power, impedance, thermal state parameters, and flow rate adjustment commands at each moment during the tissue ablation process in real time and form a corresponding parameter set.

[0091] The system continuously monitors the morphological and electrophysiological changes of lesion tissue under the action of ablation electrodes through a dedicated detection unit, and captures various signals generated by the tissue under radiofrequency ablation. When characteristic signals indicating that the ablation has achieved the expected effect are detected, such as coagulative necrosis in the lesion tissue morphology and a resting state with no electrical activity in the electrophysiological characteristics, the ablation operation is determined to be successful. Then, the system locks the entire set of ablation process parameters collected in the current time and adjacent time periods, and marks this part of the parameter set as a valid parameter combination, clarifying that it is the key parameter basis for achieving successful ablation. For example, when the expected coagulative necrosis signal is detected in the liver tissue ablation, the parameter set of the corresponding time period is immediately marked as a valid parameter combination.

[0092] All parameters in the marked valid parameter combinations are synchronously correlated across the entire domain. According to the inherent interaction logic between parameters, the correspondence between each input parameter and the output adjustment command is established. The focus is on constructing an empirical mapping relationship with biological tissue impedance and thermal state parameters as core input conditions and optimized cooling medium flow rate adjustment command that can achieve successful ablation as the output result. This relationship can accurately reflect the appropriate cooling medium flow rate adjustment strategy under specific impedance and thermal states, and ensure that the correlation between input and output parameters conforms to the parameter control logic of actual ablation.

[0093] The system pre-builds a structured knowledge base according to the type of lesion tissue, classifies and stores ablation experience data of different tissue types, and after forming an experience mapping relationship, it first accurately identifies the type of lesion tissue that was successfully ablated corresponding to the experience mapping relationship, and then stores the experience mapping relationship into the structured knowledge base of the ablation electrode according to the corresponding tissue type. All experience mapping relationships under different tissue types are summarized and integrated, and finally a self-learning parameter library of ablation electrodes that can cover ablation scenarios of multiple tissues is formed, realizing the systematic storage and management of successful ablation experience data.

[0094] When the system receives a new ablation procedure initiation command for the same type of lesion tissue, in the initial stage of the ablation operation, the system first acquires the initial biological tissue impedance of the lesion tissue in real time, and then accurately matches the initial impedance information with the empirical mapping relationship under the corresponding tissue type in the self-learning parameter library. The system retrieves the empirical mapping relationship that is suitable for the initial impedance from the library, and recommends the corresponding initial cooling medium flow rate adjustment strategy based on the relationship. This strategy is directly used as the basis for flow rate control in the initial stage of the new ablation procedure. For example, when performing a new ablation on myocardial tissue, based on the initially acquired myocardial tissue impedance, the system matches and recommends an initial flow rate adjustment strategy under the myocardial tissue classification in the self-learning parameter library, so that the new ablation operation has a precise flow rate control reference from the initial stage, improving the efficiency and accuracy of ablation control.

[0095] The beneficial effects are that the real-time collection of multi-dimensional core parameters of the ablation process and the formation of a parameter set have enabled the comprehensive and synchronous collection of ablation operation data. This provides complete and time-corresponding basic data support for the subsequent screening of successful ablation parameters, ensuring that the parameters can truly reflect the actual working conditions of ablation.

[0096] By monitoring the characteristic signals of lesion tissue morphology and electrophysiological properties to screen effective parameter combinations, the key parameters for successful ablation are accurately identified, and invalid control data are eliminated. This ensures that the empirical relationships subsequently constructed are based on actual and effective ablation practices, guaranteeing the practicality and accuracy of the parameter library.

[0097] By synchronously linking effective parameter combinations to form an empirical mapping relationship, a precise correspondence between tissue impedance, thermal state parameters and optimal flow rate adjustment commands is established. This allows flow rate control strategies under different thermal states and tissue impedances to form reusable experience, providing direct control references for subsequent similar ablation scenarios.

[0098] The system stores experience mapping relationships by categorizing them according to lesion tissue type and constructs a self-learning parameter library, realizing the systematic and classified management of ablation experience for different tissues. This allows the parameter library to adapt to the ablation needs of various lesion tissues such as liver, myocardium, and lung, improving the adaptability and scalability of the parameter library.

[0099] For ablation of similar lesions, the system matches and recommends initial flow adjustment strategies from a self-learning parameter library. This allows new ablation procedures to be precisely controlled from the initial stage based on past successful experiences, eliminating the need to re-explore parameters. This significantly improves the efficiency and initial accuracy of ablation temperature control. Furthermore, as ablation practice accumulates, the parameter library is continuously enriched and optimized, allowing the temperature control strategy to be continuously iterated and upgraded. This enables self-learning and self-optimization of ablation control, thereby improving the safety and efficacy stability of ablation surgery in the long term.

[0100] like Figure 2 The diagram shown is a functional block diagram of an ablation electrode temperature control system provided in an embodiment of the present invention.

[0101] The ablation electrode temperature control system 100 described in this invention can be installed in an electronic device. Depending on the functions implemented, the ablation electrode temperature control system 100 may include a dynamic monitoring module 101, a thermal power calculation module 102, a heat dissipation analysis module 103, a thermal state assessment module 104, a feedforward control module 105, and a self-learning optimization module 106. The module described in this invention can also be referred to as a unit, which refers to a series of computer program segments that can be executed by the processor of an electronic device and can perform a fixed function, and are stored in the memory of the electronic device.

[0102] In this embodiment, the functions of each module / unit are as follows: The dynamic monitoring module 101 is used to acquire, in real time, the output power of the ablation host and the biological tissue impedance between the ablation electrode and the lesion tissue monitored by the ablation host during the ablation process. The thermal power calculation module 102 is used to calculate the real-time heat generation power of the ablation electrode acting on the lesion tissue based on the dynamic coupling relationship between the output electrical power and the biological tissue impedance through a thermal power conversion algorithm. The heat dissipation analysis module 103 is used to simultaneously acquire the inlet temperature, outlet temperature and instantaneous flow rate of the cooling medium flowing through the internal cooling channel of the ablation electrode, and quantify the real-time heat dissipation power of the cooling medium according to the heat transfer relationship of the medium. The thermal state assessment module 104 is used to determine the thermal state parameters of the ablation electrode based on the real-time difference between the real-time heat generation power and the real-time heat dissipation power. The thermal state parameters reflect the heat accumulation trend of the ablation electrode. The feedforward control module 105 is used to dynamically adjust the flow rate of the cooling medium according to the stage of the ablation process and the thermal state parameters. The self-learning optimization module 106 is used to collect and associate successful ablation parameter combinations of biological tissues in feedforward dynamic adjustment in order to construct a self-learning parameter library for the ablation electrode.

[0103] In the several embodiments provided by this invention, it should be understood that the disclosed methods and systems can be implemented in other ways. For example, the system embodiments described above are merely illustrative; for instance, the division of modules is only a logical functional division, and other division methods may be used in actual implementation.

[0104] The modules described as separate components may or may not be physically separate. The components shown as modules may or may not be physical units; that is, they may be located in one place or distributed across multiple network units. Some or all of the modules can be selected to achieve the purpose of this embodiment according to actual needs.

[0105] Furthermore, the functional modules in the various embodiments of the present invention can be integrated into one processing unit, or each unit can exist physically separately, or two or more units can be integrated into one unit. The integrated unit can be implemented in hardware or in the form of hardware plus software functional modules.

[0106] It will be apparent to those skilled in the art that the present invention is not limited to the details of the exemplary embodiments described above, and that the present invention can be implemented in other specific forms without departing from the spirit or essential characteristics of the present invention.

[0107] This application embodiment can acquire and process relevant data based on artificial intelligence technology. Artificial intelligence is the theory, method, technology, and application system that uses digital computers or machines controlled by digital computers to simulate, extend, and expand human intelligence, perceive the environment, acquire knowledge, and use that knowledge to obtain optimal results.

[0108] Finally, it should be noted that the above embodiments are only used to illustrate the technical solutions of the present invention and are not intended to limit it. Although the present invention has been described in detail with reference to preferred embodiments, those skilled in the art should understand that modifications or equivalent substitutions can be made to the technical solutions of the present invention without departing from the spirit and scope of the technical solutions of the present invention.

Claims

1. A method for controlling the temperature of an ablation electrode, characterized in that, The method includes: S1. During the ablation process, the output power of the ablation host and the bio-tissue impedance between the ablation electrode and the lesion tissue monitored by the ablation host are acquired in real time. S2. Based on the dynamic coupling relationship between the output electrical power and the biological tissue impedance, the real-time heat generation power of the ablation electrode acting on the lesion tissue is calculated using a heat power conversion algorithm. S3. Simultaneously acquire the inlet temperature, outlet temperature and instantaneous flow rate of the cooling medium flowing through the internal cooling channel of the ablation electrode, and quantify the real-time heat dissipation power of the cooling medium according to the heat transfer relationship of the medium. S4. Determine the thermal state parameters of the ablation electrode based on the real-time difference between the real-time heat generation power and the real-time heat dissipation power. The thermal state parameters reflect the heat accumulation trend of the ablation electrode. S5. Based on the stage of the ablation process and the thermal state parameters, the flow rate of the cooling medium is dynamically adjusted in a feedforward manner. S6. In the feedforward dynamic adjustment, successful ablation parameter combinations of biological tissues are collected and correlated to construct a self-learning parameter library for the ablation electrode.

2. The ablation electrode temperature control method as described in claim 1, characterized in that, During the ablation process, the real-time acquisition of the output power of the ablation host and the bio-tissue impedance between the ablation electrode and the lesion tissue monitored by the ablation host includes: At the same time as the ablation host starts outputting radio frequency energy, a synchronous trigger signal for the ablation host is generated; Based on the aforementioned synchronous trigger signal, the acquisition of voltage and current waveforms at the output terminal of the ablation host, as well as the acquisition of excitation signals applied to the ablation electrodes and response signals from the lesion tissue, are synchronously triggered. The acquired voltage and current waveforms are subjected to signal conditioning and high-speed digital conversion to obtain the output power of the ablation host. The acquired excitation and response signals are conditioned and digitally converted at high speed to obtain the bio-tissue impedance of the ablation host.

3. The ablation electrode temperature control method as described in claim 1, characterized in that, The calculation of the real-time heat generation power of the ablation electrode acting on the lesion tissue based on the dynamic coupling relationship between the output electrical power and the biological tissue impedance, using a thermal power conversion algorithm, includes: The difference between the current biological tissue impedance and the biological tissue impedance at the previous sampling time is evaluated to obtain the instantaneous change in the biological tissue impedance. Based on the instantaneous change and the output electrical power, the instantaneous electrothermal conversion factor of the ablation electrode is constructed; The real-time heat generation power acting on the lesion tissue is calculated based on the instantaneous electrothermal conversion factor and the output electrical power.

4. The ablation electrode temperature control method as described in claim 3, characterized in that, The formula for calculating the real-time heat generation power is: ； In the formula, The real-time heat generation power, For the current moment Real-time acquisition of biological tissue impedance, These are constants derived from the principle of energy conservation and the inherent electrothermal properties of the ablation electrode. For the instantaneous change, For the current moment The output electrical power is acquired in real time.

5. The method for controlling the temperature of an ablation electrode as described in claim 1, characterized in that, The process of simultaneously acquiring the inlet temperature, outlet temperature, and instantaneous flow rate of the cooling medium flowing through the internal cooling channel of the ablation electrode, and quantifying the real-time heat dissipation power of the cooling medium based on the heat transfer relationship of the medium, includes: The inlet temperature is obtained by a first temperature sensor installed at the inlet of the cooling channel, and the outlet temperature is obtained by a second temperature sensor installed at the outlet of the cooling channel. The instantaneous flow rate of the cooling medium is obtained by a flow meter on the cooling channel; The temperature change of the cooling medium as it flows through the ablation electrode is obtained by performing a difference calculation between the inlet temperature and the outlet temperature. Based on the specific heat capacity and density parameters of the cooling medium, the temperature change value is fused to obtain the intermediate heat capacity parameter of the cooling medium. The real-time heat dissipation power of the cooling medium is obtained by jointly calculating the intermediate heat capacity parameter and the instantaneous flow rate.

6. The ablation electrode temperature control method as described in claim 1, characterized in that, The step of determining the thermal state parameters of the ablation electrode based on the real-time difference between the real-time heat generation power and the real-time heat dissipation power, wherein the thermal state parameters reflect the heat accumulation trend of the ablation electrode, includes: The difference between the real-time heat generation power and the real-time heat dissipation power is compared to obtain the real-time difference of the cooling medium. Based on the continuous change direction and rate of change of the real-time difference, the instantaneous thermodynamic stage of the ablation electrode is determined, and the stage identification signal corresponding to the instantaneous thermodynamic stage is output. The current stage of the ablation process is obtained, and the stage identifier signal is correlated with the stage of the ablation process to obtain the fusion thermal state identifier of the ablation electrode. Based on the fusion thermal state identifier, thermal state parameters of the ablation electrode are generated, and the thermal state parameters reflect the thermal accumulation trend of the ablation electrode.

7. The ablation electrode temperature control method as described in claim 6, characterized in that, The determination of the instantaneous thermodynamic stage of the ablation electrode based on the continuous change direction and rate of change of the real-time difference, and the output of the stage identification signal corresponding to the instantaneous thermodynamic stage, includes: The continuous change direction of the real-time difference is identified, including: positive direction, negative direction or stable direction close to zero, and the rate of change of the real-time difference is identified simultaneously, including: high-speed change, medium-speed change or low-speed change. Based on the direction of continuous change and the rate of change, the instantaneous thermodynamic stage of the ablation electrode is determined, wherein... When the direction of continuous change is positive and the rate of change is high speed, it is determined that the ablation electrode is in the stage of rapid heat accumulation. When the direction of continuous change is positive and the rate of change is medium or low, it is determined that the ablation electrode is in a stable heat accumulation stage. When the direction of continuous change is a stable direction, the ablation electrode is determined to be in the thermal equilibrium stage; When the direction of continuous change is negative, the ablation electrode is determined to be in the heat dissipation stage. Output the stage identifier signal corresponding to the determined instantaneous thermodynamic stage.

8. The ablation electrode temperature control method as described in claim 1, characterized in that, The step of dynamically adjusting the flow rate of the cooling medium based on the stage of the ablation process and the thermal state parameters includes: The thermal state parameters and the stage identification signal are combined and encoded to obtain the combined control index of the ablation electrode; The combined control index is mapped to the historical feedforward regulation rule base of the ablation electrode to obtain the target flow regulation command of the cooling medium. The historical feedforward regulation rule base stores the flow regulation strategies corresponding to different operation stages and different combinations of thermal state parameters. According to the target flow rate adjustment command, the flow control terminal connected to the cooling channel is driven to perform the adjustment action on the flow rate of the cooling medium.

9. The method for controlling the temperature of an ablation electrode as described in claim 1, characterized in that, In the feedforward dynamic adjustment, successful ablation parameter combinations of biological tissues are collected and correlated to construct a self-learning parameter library for the ablation electrode, including: During the feedforward dynamic adjustment execution, a set of ablation process parameters, including the output electrical power, the biological tissue impedance, the thermal state parameters, and the corresponding cooling medium flow rate adjustment command, are collected in real time. The system monitors characteristic signals that indicate expected changes in the morphology and electrophysiological properties of lesion tissue under the action of the ablation electrode. When a characteristic signal representing successful ablation is detected, the ablation process parameter set at the current time and the adjacent time period is marked as an effective parameter combination. The parameters in the effective parameter combination are synchronously correlated to form an empirical mapping relationship with the biological tissue impedance and the thermal state parameters as inputs and the optimized cooling medium flow rate adjustment command as output. Based on the lesion tissue type corresponding to the effective parameter combination, the empirical mapping relationship is stored in the structured knowledge base of the ablation electrode to obtain the self-learning parameter library of the ablation electrode. When a new ablation procedure is initiated for the same type of lesion tissue, an initial cooling medium flow rate adjustment strategy is matched and recommended from the self-learning parameter library based on the initially acquired biological tissue impedance.

10. An ablation electrode temperature control system, characterized in that, The system for implementing the ablation electrode temperature control method according to claim 1 includes: The dynamic monitoring module is used to acquire the output power of the ablation host and the bio-tissue impedance between the ablation electrode and the lesion tissue monitored by the ablation host in real time during the ablation process. The thermal power calculation module is used to calculate the real-time heat generation power of the ablation electrode acting on the lesion tissue based on the dynamic coupling relationship between the output electrical power and the impedance of the biological tissue through a thermal power conversion algorithm. The heat dissipation analysis module is used to simultaneously acquire the inlet temperature, outlet temperature and instantaneous flow rate of the cooling medium flowing through the internal cooling channel of the ablation electrode, and quantify the real-time heat dissipation power of the cooling medium according to the heat transfer relationship of the medium. The thermal state assessment module is used to determine the thermal state parameters of the ablation electrode based on the real-time difference between the real-time heat generation power and the real-time heat dissipation power. The thermal state parameters reflect the heat accumulation trend of the ablation electrode. The feedforward control module is used to dynamically adjust the flow rate of the cooling medium based on the stage of the ablation process and the thermal state parameters. The self-learning optimization module is used to collect and correlate successful ablation parameter combinations of biological tissues in feedforward dynamic adjustment to construct a self-learning parameter library for the ablation electrode.

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