Steam explosion safety early warning and control system for transcatheter heart radiofrequency ablation

Abstract

The invention discloses a steam explosion safety early warning and control system for transcatheter heart radiofrequency ablation, and relates to the field of radiofrequency ablation safety early warning and control. According to the law of the ablation parameter indexes in the radiofrequency ablation, a new function of early warning the SP event in real time and terminating ablation in time before the SP event occurs is designed, and the safety is improved. The whole system is provided with an information acquisition module, an analysis module and a control module. The control module generates an early warning control signal according to the main parameter combination standard, the auxiliary standard and the termination curve cluster which are obtained by the analysis module and used for terminating ablation, so that early warning and control of an ablation mechanism are achieved, and the effects of early warning SP in real time and terminating ablation in time before the SP occurs are achieved.

Description

Technical Field

[0001] The invention relates to the field of safety early warning control of transcatheter cardiac radiofrequency ablation, and in particular to a steam explosion safety early warning and control system for transcatheter cardiac radiofrequency ablation. Background Art

[0002] Radiofrequency catheter ablation (RFCA) is a minimally invasive interventional method and has been recommended as the first-line treatment for atrial fibrillation (AF) rhythm control. Currently, AF transcatheter RFCA has entered the era of high power and short time (efficient ablation), which significantly shortens the time of AF ablation, but inevitably leads to safety issues such as steam pop (SP) events.

[0003] Physically, RFCA-induced tissue coagulation necrosis begins with the increase in temperature after 50°C, eventually transforming into steam and erupting deep in the atrial myocardium. The probability of atrial ventricular wall rupture caused by SP events can cause malignant complications such as cardiac perforation, pericardial tamponade, and even death is much higher than that without SP events. In addition, the probability of death caused by non-SP events is less than 1 / 10000, and the probability of death caused by SP events is more than 2 / 100. Therefore, compared with non-SP events, the probability of death caused by SP events can increase by more than 200 times. However, due to the inaudible and silent characteristics of SP events, operators often cannot perceive SP events, and during RFCA, it is difficult to estimate the increased risk of SP events. Therefore, taking effective measures to identify potential SP events and avoid fatal complications as much as possible is an effective means to reduce the risk of cardiac catheter radiofrequency ablation. However, there is currently no way to predict whether and when an SP event will occur, let alone accurately warn of SP events and terminate ablation in real time. Summary of the invention

[0004] In order to solve the above problems existing in the prior art, the present invention provides a steam explosion safety warning and control system for transcatheter cardiac radiofrequency ablation.

[0005] To achieve the above object, the present invention provides the following solutions:

[0006] A steam explosion safety warning and control system for transcatheter cardiac radiofrequency ablation, comprising:

[0007] An information acquisition module, connected to the ablation device, is used to obtain baseline information, a database of ablation points where SP events occurred in history, and ablation parameter indicators during the radiofrequency ablation process; the baseline information includes: age, gender, height, and weight; the ablation parameter indicators include: ablation catheter type, impedance curve of ablation point, impedance stability, pressure curve, pressure stability, temperature curve, respiration curve, respiration stability, heartbeat curve, heartbeat stability, ablation time, power, perfusion volume, AI value, and anatomical characteristics of ablation point;

[0008] An analysis module, connected to the information acquisition module, for determining the main parameter combination standard and auxiliary standard for terminating ablation based on the ablation point data of historical SP events, and for generating a termination curve cluster corresponding to the main parameter combination standard and the auxiliary standard;

[0009] The control module is connected to the analysis module and the ablation device respectively, and is used to compare the ablation parameter index and the termination curve cluster during the radiofrequency ablation process to generate an early warning control signal, and is used to control the ablation mechanism in the ablation device based on the early warning control signal.

[0010] Optionally, the information collection module includes:

[0011] An input unit, used for inputting the baseline information;

[0012] An automatic acquisition unit, connected to the ablation device, for acquiring the ablation catheter type, impedance, pressure, temperature, respiratory volume, heartbeat, ablation time, power, perfusion volume and AI value of the ablation point;

[0013] An information generating unit is connected to the automatic acquisition unit, and is used to determine the impedance curve, impedance stability, pressure curve, pressure stability, temperature curve, breathing curve, breathing stability, heartbeat curve, heartbeat stability and anatomical features of the ablation point based on the data acquired by the automatic acquisition unit, so as to obtain ablation parameter indicators during radiofrequency ablation.

[0014] Optionally, the analysis module includes:

[0015] A sample acquisition unit connected to the information acquisition module, used to acquire the ablation point data where SP events occurred in history, and divide the historical ablation point data into SP+ group and SP- group according to whether SP events occurred during the ablation process;

[0016] a parameter screening unit, connected to the sample acquisition unit, for screening the SP event distinguishing parameters from the SP+ group and the SP- group respectively by using a statistical method;

[0017] A SP event prediction unit, connected to the parameter screening unit, for performing ROC analysis on the distinguishing parameters of SP events to obtain the sensitivity, specificity, negative predictive value and positive predictive value of each distinguishing parameter for predicting SP events;

[0018] A curve cluster generating unit is connected to the SP event prediction unit, and is used to use the distinguishing parameters with a sensitivity of 100% and a specificity of a set threshold as the main parameter combination standard, and the remaining distinguishing parameters as auxiliary standards, and generate a termination curve cluster corresponding to the main parameter combination standard and the auxiliary standards.

[0019] Optionally, the main parameter combination standard includes ablation catheter type, impedance curve, pressure curve, temperature curve, ablation time, stability parameters and anatomical features of the ablation point.

[0020] Optionally, the auxiliary criteria include a breathing curve, breathing stability, a heartbeat curve, heartbeat stability and perfusion volume.

[0021] Optionally, the control module includes:

[0022] a first relationship determination unit connected to the analysis module, for obtaining a main parameter combination standard in the ablation parameter index during the radiofrequency ablation process, and determining a relationship between the main parameter combination standard and each curve in the termination curve cluster; the termination curve cluster corresponding to the main parameter combination standard includes a first warning line and a second warning line;

[0023] an early warning control signal generating unit, connected to the first relationship determining unit and the ablation device, for generating an ablation mechanism stop signal when the main parameter combination standard reaches the first warning line, and generating an ablation mechanism early warning signal when the main parameter combination standard reaches the second warning line; the ablation mechanism stop signal is used to control the ablation device to stop working; the ablation mechanism early warning signal is used to control the ablation device to stop working after a set working time;

[0024] A second relationship determination unit, connected to the analysis module, for obtaining an auxiliary standard in the ablation parameter index during the radiofrequency ablation process, and determining a relationship between the auxiliary standard and the termination curve cluster;

[0025] The risk determination unit is connected to the second relationship determination unit, and is used to retrieve the baseline information and the ablation parameter indicators during the radiofrequency ablation process through the analysis module when the auxiliary standard reaches the termination curve cluster, and determine whether there is a risk of an SP event based on the baseline information and the ablation parameter indicators during the radiofrequency ablation process; if so, generate an ablation mechanism stop signal; if not, generate a signal to continue executing the ablation mechanism.

[0026] Optionally, the information acquisition module, the analysis module and the control module are integrated in a host computer or a controller; the host computer or the controller is connected to the ablation device.

[0027] According to the specific embodiments provided by the present invention, the present invention discloses the following technical effects:

[0028] The present invention designs a new function that can warn of SP events in real time during surgery and terminate ablation in time before SP events occur, based on the rules of ablation parameters such as ablation catheter type, impedance curve of ablation point, impedance stability, pressure curve, pressure stability, temperature curve, breathing curve, breathing stability, heartbeat curve, heartbeat stability, and anatomical characteristics of ablation points during radiofrequency ablation, thereby improving safety. Among them, according to the main parameter combination standard, auxiliary standard and termination curve cluster for terminating ablation obtained by the analysis module, an early warning control signal is generated to realize the early warning and control of the ablation mechanism, which can achieve the effect of real-time early warning of SP and timely termination of ablation before SP occurs. BRIEF DESCRIPTION OF THE DRAWINGS

[0029] In order to more clearly illustrate the embodiments of the present invention or the technical solutions in the prior art, the drawings required for use in the embodiments will be briefly introduced below. Obviously, the drawings described below are only some embodiments of the present invention. For ordinary technicians in this field, other drawings can be obtained based on these drawings without paying creative work.

[0030] Figure 1 A schematic structural diagram of a steam explosion safety warning and control system for transcatheter cardiac radiofrequency ablation provided by the present invention;

[0031] Figure 2 A schematic diagram of an impedance curve provided by the present invention;

[0032] Figure 3 A schematic diagram of SP generation provided in Example 1 of the present invention;

[0033] Figure 4 This is a schematic diagram of SP generation provided in Example 2 of the present invention. DETAILED DESCRIPTION

[0034] The following will be combined with the drawings in the embodiments of the present invention to clearly and completely describe the technical solutions in the embodiments of the present invention. Obviously, the described embodiments are only part of the embodiments of the present invention, not all of the embodiments. Based on the embodiments of the present invention, all other embodiments obtained by ordinary technicians in this field without creative work are within the scope of protection of the present invention.

[0035] The purpose of the present invention is to provide a steam explosion safety warning and control system for transcatheter cardiac radiofrequency ablation, which can accurately warn of SP events and realize real-time termination of ablation.

[0036] In order to make the above-mentioned objects, features and advantages of the present invention more obvious and easy to understand, the present invention is further described in detail below with reference to the accompanying drawings and specific embodiments.

[0037] like Figure 1 As shown, the steam explosion safety warning and control system for transcatheter cardiac radiofrequency ablation provided by the present invention includes: an information acquisition module, an analysis module and a control module. The information acquisition module is connected to the analysis module and the ablation device respectively. The analysis module and the ablation device are both connected to the control module.

[0038] Among them, the information acquisition module is used to obtain baseline information, a database of ablation points where SP events have occurred in the past, and ablation parameter indicators during the radiofrequency ablation process. Baseline information includes: age, gender, height and weight. Ablation parameter indicators include: ablation catheter type, impedance curve of ablation point, impedance stability, pressure curve, pressure stability, temperature curve, respiration curve, respiration stability, heartbeat curve, heartbeat stability, ablation time, power, perfusion volume, AI value and anatomical characteristics of ablation point. Among them, ablation catheter type, impedance curve of ablation point, impedance stability, pressure curve, pressure stability, temperature curve, respiration curve, respiration stability, heartbeat curve, heartbeat stability, ablation time, power, perfusion volume, AI value, anatomical characteristics of ablation point, etc. are all quantifiable ablation parameters.

[0039] In actual application, the information collection module used in the present invention may include the following units:

[0040] 1) Input unit, used to input baseline information.

[0041] 2) An automatic acquisition unit, connected to the ablation device, is used to obtain the ablation catheter type, impedance, pressure, temperature, respiratory volume, heartbeat, ablation time, power, perfusion volume and AI value of the ablation point.

[0042] 3) An information generating unit connected to the automatic acquisition unit is used to determine the impedance curve, impedance stability, pressure curve, pressure stability, temperature curve, breathing curve, breathing stability, heartbeat curve, heartbeat stability and anatomical characteristics of the ablation point based on the data acquired by the automatic acquisition unit, so as to obtain ablation parameter indicators during the radiofrequency ablation process.

[0043] Furthermore, the analysis module is used to determine the main parameter combination standard and the auxiliary standard for terminating ablation based on the ablation point data where the SP event occurs, and to generate a termination curve cluster corresponding to the main parameter combination standard and the auxiliary standard.

[0044] In actual application, the comprehensive analysis module adopted by the present invention further analyzes the various baselines and ablation parameter indicators collected by the information acquisition module to obtain the main parameter combination standards and auxiliary standards for warning SP events and timely terminating ablation before the SP event occurs, and automatically generates a termination curve cluster (0 seconds, 1 second, 2 seconds, etc.).

[0045] For example, the analysis module used in the present invention is implemented by the following units:

[0046] 1) A sample acquisition unit is connected to the information acquisition module and is used to obtain a database of ablation points where SP events occurred in history, and divide the historical ablation point data into an SP+ group and an SP- group according to whether an SP event occurred during the operation.

[0047] For example, the process of acquiring the ablation point data of SP events that occurred historically is as follows: 1,130 research subjects were included, with a total of 16,955 ablation points, of which 26 research subjects had SP events. The 26 research subjects had a total of 1,576 ablation points, of which 32 ablation points had SP events. The baseline parameters (i.e., baseline information) such as age, gender, height, and weight of the 26 research subjects who had SP events collected are input into the system provided by the present invention, and all quantifiable ablation parameter indicators such as the ablation catheter type, the impedance curve of the ablation point, the impedance stability, the pressure curve, the pressure stability, the temperature curve, the breathing curve, the breathing stability, the heartbeat curve, the heartbeat stability, the ablation time, the power, the perfusion volume, the AI ​​value, the anatomical characteristics of the ablation point, etc. of all 1,576 ablation points where SP events occurred are automatically captured through the connected ablation device.

[0048] The ablation point data division process was as follows: the 1576 ablation points of the 26 research subjects who had SP events (of which 32 ablation points had SP events) were divided into the SP+ group (SP events occurred) and the SP- group (SP events did not occur) according to whether the surgeons had SP events during the radiofrequency ablation surgery.

[0049] 2) A parameter screening unit, connected to the sample acquisition unit, for screening the SP event distinguishing parameters from the SP+ group and the SP- group using a statistical method.

[0050] 3) The SP event prediction unit is connected to the parameter screening unit and is used to perform ROC analysis on the distinguishing parameters of the SP events to obtain the sensitivity, specificity, negative predictive value and positive predictive value of each distinguishing parameter for predicting the SP events.

[0051] 4) A curve cluster generation unit, connected to the SP event prediction unit, is used to use the distinguishing parameters with a sensitivity of 100% and a specificity of a set threshold as the main parameter combination standard, and the remaining distinguishing parameters as auxiliary standards, and to generate a termination curve cluster corresponding to the main parameter combination standard and the auxiliary standard.

[0052] In the actual application process, the statistical methods of independent sample T test or non-parametric test and chi-square test were used to screen out the parameters that are meaningful in distinguishing SP (i.e., P<0.05), including ablation catheter type, impedance curve, pressure curve, stability parameter, temperature curve, respiration curve, heartbeat curve, ablation time, power, anatomical characteristics of ablation point, etc. Then, the parameters that are meaningful in distinguishing SP events were subjected to ROC analysis to obtain the sensitivity, specificity, negative predictive value, and positive predictive value of each parameter in predicting SP events. Among them, the continuous variables such as non-parametric test impedance curve, pressure curve, temperature curve, respiration curve, heartbeat curve, ablation time, power, perfusion volume, AI value, etc. were screened by non-parametric test methods, and the categorical variables such as ablation catheter type, impedance stability of ablation point, pressure stability, respiration stability, heartbeat stability, and anatomical characteristics of ablation point were screened by chi-square test methods.

[0053] Furthermore, for the safety (sensitivity and negative predictive value) and effectiveness (specificity and positive predictive value) of radiofrequency ablation, the quantitative parameter combination that is screened as a new function of real-time early warning of SP and timely termination of ablation before SP occurs needs to meet the goal of 100% sensitivity (negative predictive value) for predicting SP events and as high specificity as possible. The main parameter combination criteria finally selected include catheter type, impedance curve, pressure curve, temperature curve, stability parameters, ablation time, anatomical characteristics of ablation points, etc. The sensitivity of this parameter combination for early warning of SP is 100%, the negative predictive value is 100%, the positive predictive value is 22.1%, and the specificity is 95.6%, that is, the safety of early warning of SP is 100%, and the early warning efficiency is 95.6%.

[0054] For the parameters that failed to meet the above-mentioned parameter combination characteristics (i.e., the main parameter combination standards) (e.g., respiratory curve, heartbeat curve, respiratory stability, heartbeat stability, power, perfusion volume, AI value, etc.), each parameter was statistically analyzed using the univariate logistic regression method, and the parameters that satisfied P < 0.05 were selected, including respiratory curve, heartbeat curve, respiratory stability, heartbeat stability, perfusion volume, etc. These parameters can be used as clinically significant auxiliary standards for warning SP events.

[0055] In summary, the main parameter combination standards and auxiliary standards for warning SP events can be obtained.

[0056] Furthermore, the control module is used to compare the ablation parameter index and the termination curve cluster during the radiofrequency ablation process to generate an early warning control signal, and is used to control the ablation mechanism in the ablation device based on the early warning control signal.

[0057] In actual application, the control module can realize the early warning and control of ablation based on the main parameter combination standard obtained by detection and the generated termination curve cluster, so as to achieve the effect of real-time early warning of SP and timely termination of ablation before SP occurs, and can ensure that the system has a 100% sensitivity and 95.6% specificity for early warning of SP events.

[0058] In actual application, the control module can realize its functions by setting the following units:

[0059] 1) A first relationship determination unit, connected to the analysis module, is used to obtain the main parameter combination standard in the ablation parameter index during the radiofrequency ablation process, and determine the relationship between the main parameter combination standard and each curve in the termination curve cluster. The termination curve cluster corresponding to the main parameter combination standard includes a first warning line and a second warning line.

[0060] 2) A warning control signal generating unit, connected to the first relationship determining unit and the ablation device, is used to generate an ablation mechanism stop signal when the main parameter combination standard reaches the first warning line, and to generate an ablation mechanism warning signal when the main parameter combination standard reaches the second warning line. The ablation mechanism stop signal is used to control the ablation device to stop working. The ablation mechanism warning signal is used to control the ablation device to stop working after a set working time.

[0061] 3) A second relationship determination unit, connected to the analysis module, is used to obtain the auxiliary standard in the ablation parameter index during the radiofrequency ablation process and determine the relationship between the auxiliary standard and the termination curve cluster.

[0062] 4) A risk determination unit connected to the second relationship determination unit is used to retrieve the baseline information and the ablation parameter index during the radiofrequency ablation process through the analysis module when the auxiliary standard reaches the termination curve cluster, and determine whether there is a risk of SP event based on the baseline information and the ablation parameter index during the radiofrequency ablation process. If there is, a stop signal of the ablation mechanism is generated. If not, a signal to continue to execute the ablation mechanism is generated.

[0063] In the risk determination unit, the judgment process of whether there is a risk of SP event mainly relies on the medical staff and experts performing the operation. At this time, the medical staff and experts need to combine the baseline information and the ablation parameter indicators during the radiofrequency ablation process to estimate the probability of SP event. If the probability is considered high, the ablation mechanism stop signal is input. If the probability is found to be low, the warning is lifted and the ablation mechanism continues to be executed.

[0064] Based on the above description, the system provided by the present invention summarizes the rules of ablation parameters such as tissue impedance curve by analyzing various baseline indicators and all quantifiable ablation parameters, and screens out quantitative parameter combinations that can provide real-time warning of SP in the earliest stage of ablation, namely the main parameter combination standards mentioned above, among which the core parameters are catheter type, impedance curve, pressure curve, temperature curve, stability parameters, ablation time, and anatomical characteristics of ablation points.

[0065] For example, for the impedance curve parameters, the system generates an SP event curve that is fitted by the points where the SP event occurs on the impedance curves of all ablation points, that is, the 0-second warning line for the occurrence of SP, and derives a set of warning lines at any time before the occurrence of SP, that is, the warning line cluster. When the real-time impedance curve of a certain ablation point steadily decreases and intersects with a warning line in the warning line cluster, it will trigger the mechanism of stopping the ablation discharge in advance before the warning time mapped by the warning line in this system. For example, when the impedance drops to 10 ohms after 5 seconds of ablation, reaching the -3-second warning line in the SP warning line cluster, the system will automatically warn that SP will occur in 3 seconds, and will trigger the ablation stop mechanism 3 seconds in advance in real time.

[0066] Specifically, for the impedance curve parameters, the 0 second warning line in the SP warning line cluster is as follows: Figure 2 shown. Figure 2 The impedance curve shown in is a curve of impedance change with ablation time, which includes but is not limited to Figure 2 The piecewise function in is explained by the formula:

[0067]

[0068] Where Imp is the actual RF ablation impedance (unit: ohm), t is the ablation time of the current target area (unit: second), K1, K2, K3, b1, b2, b3, b4, a, b, c are all constants. When t∈[0,a], SP will not occur for any Imp value. When t=c, SP event will definitely occur when Imp exceeds e. Figure 2 In this equation, d and e are both constants.

[0069] Taking the impedance curve parameter as an example, the specific working process and the effect achieved by the steam explosion safety warning and control system for transcatheter cardiac radiofrequency ablation provided by the present invention are described below. In actual application, the implementation process of the parameters in other main parameter combination standards can refer to the implementation process of the impedance curve provided in this embodiment, and will not be repeated here.

[0070] First, the baseline information of the subjects, such as age, gender, height, weight, and all quantifiable ablation parameter information, such as the ablation catheter type, impedance curve of the ablation point, pressure curve, temperature curve, respiration curve, heart rate curve, ablation time, power, perfusion volume, AI value, and anatomical characteristics of the ablation point were collected.

[0071] Secondly, the collected information is analyzed to generate the 0-second warning line when SP occurs, and derive the warning line clusters at any time before the occurrence of SP.

[0072] Finally, when the real-time impedance curve of a certain ablation point steadily decreases and intersects with a certain warning line in the warning line cluster, the warning time mapped by the warning line will be triggered, and the ablation discharge mechanism will be stopped before the warning time to control the radiofrequency ablation catheter in the ablation device to stop ablation, thereby achieving the effect of real-time warning of SP and timely termination of ablation before SP occurs.

[0073] Example 1

[0074] like Figure 3 As shown, t=11.75 seconds when SP occurs touches the 0-second warning line of the impedance curve. At this time, SP occurs when Imp stably drops to 16Ω. However, in fact, while generating the 0-second warning line, the system of this embodiment also derives a warning line cluster of any time before the occurrence of SP. Therefore, when the impedance curve at any time before 11.75 seconds intersects with the warning line cluster, ablation will be stopped in time to warn SP in advance and ensure its safety.

[0075] Among them, when t∈[0,3.5], SP will not occur when Imp is any value; when t=11.75 seconds, SP occurs when Imp steadily drops to 16Ω.

[0076] In this embodiment, although the focus is on the impedance curves of Imp and t, the Imp curve also reflects the combined effects of all quantifiable ablation parameters such as ablation catheter type, impedance curve, pressure curve, temperature curve, respiration curve, heartbeat curve, ablation time, power, perfusion volume, AI value, and anatomical characteristics of the ablation point.

[0077] Example 2

[0078] In this embodiment, if Figure 4 As shown, t=11 seconds touches the 0-second warning line of the impedance curve, at which time Imp steadily drops to 17Ω and SP occurs. However, in fact, while generating the 0-second warning line, the system of this embodiment derives a warning line cluster for any time before the occurrence of SP. Therefore, when the impedance curve at any time before 11 seconds intersects with the warning line cluster, ablation is stopped in time, which can provide an early warning of SP and ensure its safety.

[0079] Among them, when t∈[0,5], SP will not occur when Imp is any value; when t=11 seconds, SP occurs when Imp steadily drops to 17Ω.

[0080] In summary, based on the description of the two examples, in the initial certain period of time, no matter how much the impedance drops, SP will not occur, but after a certain period of time, the impedance will steadily drop to a certain level, and the impedance will surge, that is, SP will occur. However, if the early warning control function of this system is used, SP can be warned in advance and ablation can be stopped in advance to ensure safety.

[0081] In addition, the steam explosion safety warning and control system for transcatheter cardiac radiofrequency ablation provided by the present invention can be equivalent to a host computer or controller, that is, the information acquisition module, analysis module and control module are integrated and set in the host computer or controller; the host computer or controller is connected to the ablation device. Based on this implementation result, the stop mechanism of the warning SP event can be iteratively upgraded through AI machine learning and other methods.

[0082] The various embodiments in this specification are described in a progressive manner, and each embodiment focuses on the differences from other embodiments. The same or similar parts between the various embodiments can be referenced to each other.

[0083] The principles and implementation methods of the present invention are described in this article using specific examples. The description of the above embodiments is only used to help understand the method and core idea of ​​the present invention. At the same time, for those skilled in the art, according to the idea of ​​the present invention, there will be changes in the specific implementation methods and application scope. In summary, the content of this specification should not be understood as limiting the present invention.

Claims

1. A steam explosion safety warning and control system for transcatheter cardiac radiofrequency ablation, It is characterized in that include: An information acquisition module, connected to the ablation device, is used to obtain baseline information, a database of ablation points where SP events have occurred in the past, and ablation parameter indicators during the radiofrequency ablation process; The baseline information includes: age, gender, height and weight; the ablation parameter indicators include: ablation catheter type, impedance curve of ablation point, impedance stability, pressure curve, pressure stability, temperature curve, respiration curve, respiration stability, heartbeat curve, heartbeat stability, ablation time, power, perfusion volume, AI value and anatomical characteristics of ablation point; An analysis module, connected to the information acquisition module, for determining the main parameter combination standard and auxiliary standard for terminating ablation based on the ablation point database of historical SP events, and for generating a termination curve cluster corresponding to the main parameter combination standard and the auxiliary standard; The control module is connected to the analysis module and the ablation device respectively, and is used to compare the ablation parameter index and the termination curve cluster during the radiofrequency ablation process to generate an early warning control signal, and is used to control the ablation mechanism in the ablation device based on the early warning control signal.

2. The steam explosion safety warning and control system for transcatheter cardiac radiofrequency ablation according to claim 1, It is characterized in that The information collection module includes: An input unit, used for inputting the baseline information; An automatic acquisition unit, connected to the ablation device, for acquiring the ablation catheter type, impedance, pressure, temperature, respiratory volume, heartbeat, ablation time, power, perfusion volume and AI value of the ablation point; An information generating unit is connected to the automatic acquisition unit, and is used to determine the impedance curve, impedance stability, pressure curve, pressure stability, temperature curve, breathing curve, breathing stability, heartbeat curve, heartbeat stability and anatomical features of the ablation point based on the data acquired by the automatic acquisition unit, so as to obtain ablation parameter indicators during radiofrequency ablation.

3. The steam explosion safety warning and control system for transcatheter cardiac radiofrequency ablation according to claim 1, It is characterized in that The analysis module comprises: A sample acquisition unit connected to the information acquisition module, used to acquire the ablation point data where SP events occurred in history, and divide the historical ablation point data into SP+ group and SP- group according to whether SP events were found during the ablation process; a parameter screening unit, connected to the sample acquisition unit, for screening the SP event distinguishing parameters from the SP+ group and the SP- group respectively by using a statistical method; A SP event prediction unit, connected to the parameter screening unit, for performing ROC analysis on the distinguishing parameters of SP events to obtain the sensitivity, specificity, negative predictive value and positive predictive value of each distinguishing parameter for predicting SP events; A curve cluster generating unit is connected to the SP event prediction unit, and is used to use the distinguishing parameters with a sensitivity of 100% and a specificity of a set threshold as the main parameter combination standard, and the remaining distinguishing parameters as auxiliary standards, and generate a termination curve cluster corresponding to the main parameter combination standard and the auxiliary standards.

4. The steam explosion safety warning and control system for transcatheter cardiac radiofrequency ablation according to claim 3, It is characterized in that The main parameter combination standard includes the ablation catheter type, the impedance curve, the pressure curve, the temperature curve, the ablation time, the stability parameter and the anatomical characteristics of the ablation point.

5. The steam explosion safety warning and control system for transcatheter cardiac radiofrequency ablation according to claim 3, It is characterized in that The auxiliary criteria include a respiratory curve, a respiratory stability, a heartbeat curve, a heartbeat stability and a perfusion volume.

6. The steam explosion safety warning and control system for transcatheter cardiac radiofrequency ablation according to claim 1, It is characterized in that The control module comprises: a first relationship determination unit connected to the analysis module, for obtaining a main parameter combination standard in the ablation parameter index during the radiofrequency ablation process, and determining a relationship between the main parameter combination standard and each curve in the termination curve cluster; the termination curve cluster corresponding to the main parameter combination standard includes a first warning line and a second warning line; an early warning control signal generating unit, connected to the first relationship determining unit and the ablation device, for generating an ablation mechanism stop signal when the main parameter combination standard reaches the first warning line, and generating an ablation mechanism early warning signal when the main parameter combination standard reaches the second warning line; the ablation mechanism stop signal is used to control the ablation device to stop working; the ablation mechanism early warning signal is used to control the ablation device to stop working after a set working time; A second relationship determination unit, connected to the analysis module, for obtaining an auxiliary standard in the ablation parameter index during the radiofrequency ablation process, and determining a relationship between the auxiliary standard and the termination curve cluster; The risk determination unit is connected to the second relationship determination unit, and is used to retrieve the baseline information and the ablation parameter indicators during the radiofrequency ablation process through the analysis module when the auxiliary standard reaches the termination curve cluster, and determine whether there is a risk of an SP event based on the baseline information and the ablation parameter indicators during the radiofrequency ablation process; if so, generate an ablation mechanism stop signal; if not, generate a signal to continue executing the ablation mechanism.

7. The steam explosion safety warning and control system for transcatheter cardiac radiofrequency ablation according to claim 1, It is characterized in that The information acquisition module, the analysis module and the control module are integrated in a host computer or a controller; the host computer or the controller is connected to the ablation device.

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