Cardiac arrhythmia radiofrequency ablation catheter

Abstract

The application discloses a kind of arrhythmia radiofrequency ablation catheter, belong to radiofrequency ablation technical field.The arrhythmia radiofrequency ablation catheter of the application, including control handle, the control handle is fixed in ablation catheter body outside, radiofrequency ablation assembly is worn in the outer periphery of ablation catheter body, the top of radiofrequency ablation assembly is equipped with positioning sensor, positioning sensor below is provided with reference electrode, radiofrequency catheter is arranged in control handle, temperature control assembly is installed in the outside of radiofrequency catheter.The application solves the problem that the pressure, temperature of prior art radiofrequency ablation catheter is too high and easily leads to cardiac tissue excessive ablation, carbonization and scabbing, the application can ensure that the abutting pressure of ablation electrode and cardiac tissue is always in standard pressure range by real-time acquisition of the abutting pressure between ablation electrode and cardiac tissue, avoid the problem of excessive ablation, carbonization and scabbing during ablation surgery, reduce the risk of ablation surgery.

Description

TECHNICAL FIELD

[0001] The present application relates to the technical field of radio frequency ablation, in particular to a kind of arrhythmia radio frequency ablation catheter. BACKGROUND

[0002] Radio frequency ablation technology is widely used in cardiac treatment surgery, generally used for treating tachyarrhythmia (atrial fibrillation, atrial flutter, paroxysmal supraventricular tachycardia, premature ventricular contraction, ventricular tachycardia, etc.

[0003] The Chinese patent with publication number CN219250402U discloses an arrhythmia radio frequency ablation catheter, which comprises an ablation tube main body, a head electrode fixedly installed at one end of the ablation tube main body, a control handle arranged at the other end of the ablation tube, and a connecting seat integrally arranged on the head electrode. The head electrode is fixedly installed with the ablation tube main body through the connecting seat. A plurality of clamping grooves penetrating into the connecting seat are symmetrically arranged on the outer circumferential surface of the connecting seat. A clamping head is clamped in the clamping grooves. The opposite surface of the clamping head is integrally connected with a connecting steel sheet. The distal end of the connecting steel sheet is integrally connected with a fixing tube. The fixing tube is fixedly connected with a pull wire in the interior thereof. The clamping head integrally connected with the connecting steel sheet is clamped with the clamping grooves, which not only avoids the tediousness of twice welding by means of connecting pieces, but also prevents the risk of falling of the head electrode, so that the head electrode connecting structure of the radio frequency ablation catheter is more firm, durable, simple and easy to assemble.

[0004] In the actual use process of the above-mentioned patent, with the continuous input of radio frequency energy during the operation process, the temperature between the ablation electrode and the tissue interface will continuously rise. When the temperature between the ablation electrode and the tissue interface exceeds about 80 degrees, blood adhesion, carbonization and scabbing will quickly occur in the heat zone at the distal end of the ablation electrode, which will lead to venous thrombosis and increased surface impedance. The high pressure and temperature of the radio frequency ablation catheter can easily cause excessive ablation, carbonization and scabbing of the heart tissue, thereby increasing the risk of the ablation operation. Therefore, the existing needs are not met, and a new type of arrhythmia radio frequency ablation catheter is proposed. SUMMARY

[0005] The present application aims to provide an arrhythmia radio frequency ablation catheter, which can ensure that the ablation electrode and the heart tissue are always in contact with the standard pressure range, reduce the complications such as carbonization and steam burst, further ensure the safety of the operation, and ensure the accurate release of the ablation energy in the target area through temperature monitoring and real-time pressure feedback, reduce the invalid damage, avoid the problems of excessive ablation, carbonization and scabbing during the ablation operation, reduce the risk of the ablation operation, shorten the operation time, and solve the problems raised in the above background technology.

[0006] In order to achieve the above object, the present application provides the following technical scheme: an arrhythmia radiofrequency ablation catheter, comprising a control handle and an ablation catheter body, the control handle is fixed outside the ablation catheter body, a radiofrequency ablation assembly is sleeved on the outer periphery of the ablation catheter body, the top of the radiofrequency ablation assembly is provided with a positioning sensor, the positioning sensor is fixed on a tip portion, a reference electrode is arranged below the positioning sensor, a radiofrequency catheter is arranged in the control handle, and a temperature control assembly is arranged on the outer side of the radiofrequency catheter.

[0007] Preferably, the radiofrequency ablation assembly comprises a balloon, ablation electrodes, pressure sensors, first temperature sensors, a developing element, second temperature sensors and a distal end portion, three groups of ablation electrodes are arranged equidistantly on the outer side of the balloon along the longitudinal axis direction of the balloon, the ablation electrodes are connected with radiofrequency cables, the pressure sensors and the first temperature sensors are arranged between two groups of ablation electrodes, the distal end portion extends into the balloon, the developing element and the second temperature sensors are arranged on the distal end portion, and an air inlet and a pressure relief valve are arranged at the bottom of the balloon, and the air inlet is connected with a gas filling pipe.

[0008] Preferably, the temperature control assembly comprises a cold water tank, a heating pipe and a water outlet pipe, the cold water tank is arranged in the control handle, the water outlet pipe is arranged on the side surface of the cold water tank, a water inlet pipe is arranged at the top of the cold water tank, the heating pipe is arranged at the bottom of the cold water tank, and an electric heating wire is arranged in the heating pipe.

[0009] Preferably, the radiofrequency catheter is provided with a radiofrequency cable and a liquid inlet pipe, the radiofrequency cable is connected with the ablation electrodes, the liquid inlet pipe is connected with the distal end portion, the pressure sensors, the first temperature sensors and the second temperature sensors are connected with an analysis system through sensor cables, the ablation electrodes, the developing element and the positioning sensor are connected with a radiofrequency system through the radiofrequency cable.

[0010] Preferably, the analysis system comprises:

[0011] A temperature acquisition module is arranged for collecting the temperature of an arrhythmia region and the temperature of the radiofrequency catheter during operation by using the first temperature sensor and the second temperature sensor respectively;

[0012] A pressure acquisition module is arranged for collecting the abutting pressure between the ablation electrodes and the heart tissue in real time by using the pressure sensor;

[0013] An analysis module is arranged for analyzing the data collected by the temperature acquisition module and the pressure acquisition module, and adjusting the temperature and the pressure of the radiofrequency ablation according to the analysis result.

[0014] Preferably, the analysis module comprises:

[0015] A radiofrequency region standard temperature interval is set, when the temperature exceeds the set radiofrequency region standard temperature interval, the power of the radiofrequency is reduced to prevent the carbonization of the tissue;

[0016] At the same time, cold water is injected into the cold water tank through the water inlet pipe to reduce the temperature of the radio frequency catheter;

[0017] When the temperature is lower than the set radio frequency region standard temperature interval, the power of the radio frequency is increased, and the radio frequency catheter is heated by the heating pipe;

[0018] The ablation electrode and the heart tissue are in contact with the pressure standard value interval, and when the ablation electrode and the heart tissue are in contact with the pressure standard value interval, the pressure relief valve is controlled to release the pressure of the balloon to reduce the contact pressure between the ablation electrode and the heart tissue;

[0019] When the contact pressure between the ablation electrode and the heart tissue is lower than the set standard value interval, the balloon is inflated to increase the contact pressure between the ablation electrode and the heart tissue;

[0020] The pressure data and the radio frequency energy parameters are recorded synchronously, and the tissue joule heat generation efficiency and heat conduction characteristics under different pressure values are analyzed, and the damage of the heart tissue during ablation is determined according to the tissue joule heat generation efficiency and heat conduction characteristics under different pressure values.

[0021] Preferably, the analysis module further comprises:

[0022] The pressure data of the catheter and the radio frequency energy parameters are recorded synchronously, and the pressure data is recorded and classified according to the pressure range to obtain a classified data table;

[0023] The radio frequency energy parameters corresponding to the same pressure interval are extracted from the classified data table to obtain a radio frequency energy parameter table corresponding to each pressure interval;

[0024] It is judged whether the time stamp of the radio frequency energy parameter in the radio frequency energy parameter table and the time stamp of the corresponding pressure data have a time sequence deviation greater than a time sequence deviation corresponding to a preset radio frequency accuracy;

[0025] If the time stamp corresponding time sequence deviation is greater than the time sequence deviation corresponding to the preset radio frequency accuracy, it is judged that the current radio frequency energy parameter has an error, and the radio frequency energy parameter with the error is removed to obtain an optimized radio frequency energy parameter table;

[0026] Based on the radio frequency energy parameters in the optimized radio frequency energy parameter table, an optimized radio frequency energy parameter corresponding to the current pressure interval is obtained;

[0027] The optimized radio frequency energy parameters corresponding to each pressure interval are integrated to obtain optimized radio frequency energy parameters under different pressure values;

[0028] Based on the Joule law, the tissue joule heat generation efficiency under different pressure values is determined;

[0029] The heart tissue model of the target patient is constructed by combining relevant images and real-time operation data, so as to determine the heat damage parameters related to heat conduction characteristics by using a preset simulation scheme;

[0030] According to the correlation between the heat damage parameters and the pressure, a pressure-damage relationship curve is obtained, and damage progression prediction is performed according to the curve change trend.

[0031] Based on the damage prediction result and the corresponding tissue joule heat generation efficiency, the damage of the heart tissue of the target patient during radiofrequency ablation under different pressure values is obtained, so as to adjust the temperature data and pressure data of the radiofrequency ablation in real time.

[0032] Preferably, the radiofrequency system comprises:

[0033] The processing module is configured to determine the expansion range of the ablation electrode required by the current arrhythmia region and the pushing distance corresponding to the expansion range information, and control the radiofrequency ablation assembly to push according to the pushing distance.

[0034] The positioning module is configured to receive the signal of the positioning sensor, and obtain the positioning information of the tip portion of the ablation electrode inserted into the arrhythmia region according to the signal of the positioning sensor.

[0035] The display module is configured to display the pushing distance of the radiofrequency ablation assembly and the process of the radiofrequency ablation.

[0036] Preferably, the processing module specifically comprises:

[0037] The preset radiofrequency ablation expansion range and the pushing distance of the radiofrequency ablation assembly are matched with the current arrhythmia region, the adjustment expansion range of the preset radiofrequency ablation expansion range is determined, the expansion range of the ablation electrode required by the current arrhythmia region is determined, and the expansion range of the ablation electrode required by the current arrhythmia region is defined as the expansion range information.

[0038] The preset radiofrequency ablation assembly pushing distance and the expansion range information are matched, the pushing distance corresponding to the expansion range information is determined, and the pushing distance corresponding to the expansion range information is defined as the pushing distance information.

[0039] The ablation electrode is inserted into the arrhythmia region and pushed according to the pushing distance information, and the radiofrequency ablation treatment is performed on the arrhythmia region.

[0040] Compared with the prior art, the present application has the following advantages:

[0041] This invention utilizes a pressure sensor to monitor the contact pressure between the ablation electrode and the heart tissue in real time. Based on this real-time pressure, the balloon is depressurized and pressurized, ensuring the contact pressure remains within the standard range. This prevents incomplete ablation due to insufficient pressure or cardiac perforation due to excessive pressure. A first and second temperature sensor collect the temperature of the arrhythmia area and the operating temperature of the radiofrequency catheter, providing real-time feedback. If the monitored temperature deviates from the standard range, adjustments are made promptly, ensuring surgical safety. By combining temperature monitoring with real-time pressure feedback, the ablation energy is precisely released within the target area, reducing ineffective damage and avoiding over-ablation, carbonization, and eschar formation during the ablation procedure. This reduces the risk of ablation and shortens the operation time. Attached Figure Description

[0042] Figure 1 This is a schematic diagram of the structure of a radiofrequency ablation catheter for arrhythmia according to the present invention;

[0043] Figure 2 This is a partial internal structural diagram of a radiofrequency ablation catheter for arrhythmia according to the present invention.

[0044] Figure 3 This is a schematic diagram of a radiofrequency ablation assembly for a radiofrequency ablation catheter for arrhythmia according to the present invention;

[0045] Figure 4 This is a schematic diagram of a radiofrequency ablation component of a radiofrequency ablation catheter for arrhythmia according to the present invention.

[0046] Figure 5 This is a schematic diagram of the temperature control component of a radiofrequency ablation catheter for arrhythmia according to the present invention;

[0047] Figure 6 This is a flowchart of a radiofrequency ablation catheter for arrhythmia according to the present invention.

[0048] In the diagram: 1. Control handle; 2. Ablation catheter body; 3. Radiofrequency ablation assembly; 31. Balloon; 32. Ablation electrode; 33. Pressure sensor; 34. First temperature sensor; 35. Imaging element; 36. Second temperature sensor; 37. Distal end; 38. Air inlet; 39. Pressure relief valve; 4. Positioning sensor; 5. Reference electrode; 6. Tip; 7. Analysis system; 8. Radiofrequency system; 9. Temperature control assembly; 91. Cold water tank; 92. Heating tube; 93. Water outlet tube; 94. Water inlet tube; 10. Radiofrequency catheter; 11. Sensor cable; 12. Inflation tube; 13. Radiofrequency cable; 14. Liquid inlet tube. Detailed Implementation

[0049] The technical solutions in the embodiments of the present application will be clearly and completely described below with reference to the drawings in the embodiments of the present application. Obviously, the described embodiments are only part of the embodiments of the present application, rather than all the embodiments. Based on the embodiments in the present application, all other embodiments obtained by those of ordinary skill in the art without creative work fall within the protection scope of the present application.

[0050] To solve the problem that, in the prior art, as radio frequency energy is continuously input during a surgical process, the temperature between an ablation electrode and a tissue interface continuously rises, when the temperature between the ablation electrode and the tissue interface exceeds about 80 degrees, blood coagulation, carbonization and scabbing rapidly occur in a heat zone at a distal end of the ablation electrode, leading to venous thrombosis and increased surface impedance, and high pressure and temperature of a radio frequency ablation catheter easily lead to excessive ablation, carbonization and scabbing of cardiac tissue, thereby increasing the risk of an ablation operation, please refer to Figures 1-6 The present embodiment provides the following technical solutions:

[0051] The present embodiment provides the following technical solutions:

[0052] The radio frequency ablation assembly 3 comprises a balloon 31, an ablation electrode 32, a pressure sensor 33, a first temperature sensor 34, a developing element 35, a second temperature sensor 36 and a distal end part 37. Three groups of ablation electrodes 32 are equidistantly arranged on the outer side of the balloon 31 along the longitudinal axis direction of the balloon 31. The ablation electrodes 32 are connected with the radio frequency cable 13. The pressure sensor 33 and the first temperature sensor 34 are arranged between two groups of ablation electrodes 32. The distal end part 37 extends into the balloon 31. The developing element 35 and the second temperature sensor 36 are arranged on the distal end part 37. The bottom of the balloon 31 is provided with an air inlet 38 and a pressure relief valve 39. The air inlet 38 is connected with the inflation tube 12.

[0053] The temperature control assembly 9 comprises a cold water tank 91, a heating pipe 92 and a water outlet pipe 93. The cold water tank 91 is arranged in the control handle 1. The side of the cold water tank 91 is provided with the water outlet pipe 93. The top of the cold water tank 91 is provided with a water inlet pipe 94. The bottom of the cold water tank 91 is provided with the heating pipe 92. The heating pipe 92 is provided with an electric heating wire.

[0054] The radio frequency cable 13 is connected with the ablation electrode 32, and the liquid inlet pipe 14 is connected with the distal end 37. The pressure sensor 33, the first temperature sensor 34 and the second temperature sensor 36 are connected with the analysis system 7 through the sensor cable 11. The ablation electrode 32, the developing element 35 and the positioning sensor 4 are connected with the radio frequency system 8 through the radio frequency cable 13.

[0055] When the temperature exceeds the set radio frequency area standard temperature interval, the power of the radio frequency is reduced to prevent the carbonization of the tissue. At the same time, the cold water tank 91 is injected with cold water through the water inlet pipe 94 to reduce the working temperature of the radio frequency catheter 10. When the temperature is lower than the set radio frequency area standard temperature interval, the power of the radio frequency is increased, and the radio frequency catheter 10 is heated by the heating pipe 92 to avoid the problems of excessive ablation, carbonization and scabbing during the ablation operation, reduce the risk of the ablation operation, and shorten the operation time.

[0056] The analysis system 7 comprises:

[0057] The temperature acquisition module is used for collecting the temperature of the arrhythmia area and the temperature of the radio frequency catheter 10 in operation by the first temperature sensor 34 and the second temperature sensor 36 respectively.

[0058] The pressure acquisition module is used for collecting the abutting pressure between the ablation electrode 32 and the heart tissue in real time by the pressure sensor 33.

[0059] The analysis module is used for analyzing the data collected by the temperature acquisition module and the pressure acquisition module, and adjusting the temperature and pressure of the radio frequency ablation according to the analysis result.

[0060] The analysis module comprises:

[0061] The radio frequency area standard temperature interval is set. When the temperature exceeds the set radio frequency area standard temperature interval, the power of the radio frequency is reduced to prevent the carbonization of the tissue.

[0062] At the same time, the cold water tank 91 is injected with cold water through the water inlet pipe 94 to reduce the working temperature of the radio frequency catheter 10.

[0063] When the temperature is lower than the set radio frequency area standard temperature interval, the power of the radio frequency is increased, and the radio frequency catheter 10 is heated by the heating pipe 92.

[0064] The abutting pressure standard value interval between the ablation electrode 32 and the heart tissue is set. When the abutting pressure between the ablation electrode 32 and the heart tissue exceeds the set standard value interval, the pressure relief valve 39 is controlled to release the pressure of the balloon 31 to reduce the abutting pressure between the ablation electrode 32 and the heart tissue.

[0065] When the contact pressure between the ablation electrode 32 and the heart tissue is lower than a set standard value interval, the balloon 31 is inflated to increase the contact pressure between the ablation electrode 32 and the heart tissue;

[0066] Synchronize the pressure data and the radio frequency energy parameters, analyze the tissue joule heat generation efficiency and heat conduction characteristics under different pressure values, and determine the damage of the heart tissue during ablation according to the tissue joule heat generation efficiency and heat conduction characteristics under different pressure values. The high pressure area is easy to cause more concentrated energy deposition and larger heat damage range.

[0067] By setting the pressure sensor 33, the contact pressure between the ablation electrode 32 and the heart tissue is monitored in real time, and the balloon 31 is depressurized and pressurized according to the real-time monitored contact pressure between the ablation electrode 32 and the heart tissue, which can ensure that the contact pressure between the ablation electrode 32 and the heart tissue is always within the standard pressure range, avoid incomplete ablation due to insufficient pressure or heart perforation caused by excessive pressure, and through the first temperature sensor 34 and the second temperature sensor 36, the temperature of the arrhythmia area and the temperature of the radio frequency catheter 10 during operation are collected respectively, and the temperature of the arrhythmia area and the working temperature of the radio frequency catheter 10 are fed back in real time. When the monitored real-time temperature is not within the standard temperature range, it can be adjusted in time to ensure the safety of the operation. Through temperature monitoring combined with real-time pressure feedback, it ensures that the ablation energy is accurately released in the target area, and reduces invalid damage.

[0068] The analysis module further comprises:

[0069] Synchronize the pressure data of the catheter with the radio frequency energy parameters, and record and classify the pressure data according to the pressure range to obtain a classification data table;

[0070] Extract the radio frequency energy parameters corresponding to the same pressure interval from the classification data table to obtain a radio frequency energy parameter table corresponding to each pressure interval;

[0071] Determine whether the time sequence deviation of the time stamp of the radio frequency energy parameter in the radio frequency energy parameter table and the time stamp of the corresponding pressure data is greater than the time sequence deviation corresponding to the preset radio frequency accuracy;

[0072] If the time stamp corresponding time sequence deviation is greater than the time sequence deviation corresponding to the preset radio frequency accuracy, it is judged that the current radio frequency energy parameter has error, and the radio frequency energy parameter with error is removed to obtain an optimized radio frequency energy parameter table;

[0073] Based on the radio frequency energy parameters in the optimized radio frequency energy parameter table, the optimized radio frequency energy parameters corresponding to the current pressure interval are obtained;

[0074] Integrate the optimized radio frequency energy parameters corresponding to each pressure interval to obtain the optimized radio frequency energy parameters under different pressure values.

[0075] determine tissue joule heat generation efficiency under different pressure values based on Joule's law;

[0076] Combine the relevant images of the target patient and the real-time operation data to construct a patient heart tissue model, and determine the thermal damage parameters related to the heat conduction characteristics by using the preset simulation simulation scheme;

[0077] According to the correlation between the thermal damage parameters and the pressure, the pressure-damage relationship curve is obtained, and the damage progression is predicted according to the curve trend;

[0078] Based on the damage prediction results and the corresponding tissue joule heat generation efficiency, the damage of the target patient's heart tissue during radiofrequency ablation under different pressure values is obtained, so as to adjust the temperature data and pressure data of radiofrequency ablation in real time.

[0079] In this embodiment, the catheter pressure data is the pressure value measured by the pressure sensor when the front end of the catheter contacts the heart tissue, for example, when ablation of the pulmonary vein is performed, the catheter pressure data generally needs to be maintained at 10-20g to ensure effective adhesion.

[0080] In this embodiment, the radiofrequency energy parameter is an energy-related parameter output by the radiofrequency generator during radiofrequency ablation, for example, when the power is set to 25W, the energy deposition rate is 18W, and the corresponding pressure range needs to be matched.

[0081] In this embodiment, the timestamp is a time marker used to record the time when the pressure data and the radiofrequency energy parameter are collected, and the timestamp interval is different according to the different preset radiofrequency accuracy, for example, the timestamp is usually accurate to milliseconds (ms).

[0082] In this embodiment, the classification data table is a table for storing pressure data and corresponding radiofrequency energy parameters according to pressure ranges, for example, the pressure range 10-20g corresponds to the data record of power 20-25W.

[0083] In this embodiment, the time sequence deviation refers to the difference between the radiofrequency energy parameter timestamp and the corresponding pressure data timestamp, that is, Δt is the absolute value of the difference between the radiofrequency energy parameter timestamp and the corresponding pressure data timestamp, if the energy parameter timestamp lags behind the pressure data by 60ms, it is determined as error data.

[0084] In this embodiment, the optimized radiofrequency energy parameter table refers to the table containing the corresponding relationship between the effective pressure and the energy parameter generated after removing the error data, for each pressure interval P, the average value or the median value of the optimized radiofrequency energy parameter is calculated to obtain the representative radiofrequency energy parameter under the current pressure value.

[0085] In this embodiment, the Joule heat generation efficiency is the tissue absorption heat efficiency calculated based on Joule's law, for example, when the pressure is 15 g, the tissue Joule heat generation efficiency is 80%.

[0086] In this embodiment, the thermal injury parameters include injury volume and injury depth, etc., wherein the injury volume is the three-dimensional volume of irreversible injury area, and the injury depth is the vertical distance from the tissue surface to the injury core, for example, when the pressure is 20 g, the injury volume is 50 mm 3 , and over-ablation needs to be avoided.

[0087] In this embodiment, the pressure-injury relationship curve is a relationship curve drawn with pressure as the horizontal axis and thermal injury parameters as the vertical axis, wherein each thermal injury parameter corresponds to a pressure-injury relationship curve, for example, the curve shows that the injury volume linearly increases when the pressure is 15-20 g, prompting that the upper limit of the pressure needs to be controlled.

[0088] In this embodiment, the patient's heart tissue model is a three-dimensional geometric model constructed based on the patient's CT / MRI images, which contains the anatomical structure and tissue characteristics of the heart, can simulate the heat conduction and injury distribution in the process of radiofrequency ablation, and also needs to combine the patient's intraoperative real-time data (such as catheter position, pressure, temperature) to dynamically update the model parameters.

[0089] In this embodiment, the simulation scheme is a computer simulation process based on physical models (such as the Pennes bio-heat equation) and numerical methods (such as the finite element method), which is used to predict the thermal injury distribution under different pressure and energy parameters.

[0090] In this embodiment, the injury progression prediction is to predict the change trend of the injury volume or depth in a period of time according to the pressure-injury relationship curve and the simulation results, for example, if the curve slope increases, it prompts to reduce the power or pressure to avoid perforation.

[0091] In this embodiment, the real-time adjustment of radiofrequency ablation parameters is to dynamically adjust the output parameters (such as power, temperature threshold) of the radiofrequency generator and the catheter pressure according to the injury prediction results and the Joule heat generation efficiency, if the injury is insufficient, increase the power or pressure; if the injury risk is too high, reduce the power or terminate the ablation, for example, when the predicted injury approaches the perforation threshold, immediately reduce the power to 20 W and reduce the pressure to 10 g.

[0092] The working principle of the technical scheme is as follows: first, the catheter pressure and radio frequency energy parameters are synchronously collected, the data is classified according to the pressure range, and the error data with a large timestamp deviation is removed, so as to realize radio frequency energy parameter optimization and ensure parameter reliability; second, the tissue joule heat generation efficiency is calculated based on the optimized radio frequency energy parameters, and the heart tissue model is constructed combined with the patient image and the corresponding real-time data, and the heat damage parameters are determined through simulation; then, the pressure-damage relationship curve is used to predict the damage progress trend, and the correlation between pressure and heat damage is determined; finally, according to the damage prediction result and the joule heat efficiency, the temperature data and pressure data of radio frequency ablation are dynamically adjusted: if the heat damage is insufficient, the radio frequency energy parameters or the pressure data are increased, and if the heat damage risk is too high, the radio frequency energy parameters or the pressure data are reduced.

[0093] The beneficial effects of the above technical scheme are: by recording the catheter pressure and radio frequency energy parameters, synchronizing and classifying the data, and removing the error data for parameter optimization, the simulation analysis is carried out based on the optimized parameters and the patient-specific model, so that the precision of the ablation parameters is effectively improved, and the relationship between pressure and damage can be more accurately reflected, the damage progress trend can be predicted, so as to realize the precise and timely dynamic adjustment of the ablation parameters, effectively improve the safety and success rate of radio frequency ablation, and provide a more personalized treatment plan.

[0094] The radio frequency system 8 comprises:

[0095] The processing module is configured to determine the expansion range of the ablation electrode 32 required by the current arrhythmia region and the pushing distance corresponding to the expansion range information, and control the radio frequency ablation assembly 3 to push according to the pushing distance.

[0096] The positioning module is configured to receive the signal of the positioning sensor 4, and obtain the positioning information of the tip portion 6 of the ablation electrode 32 inserted into the arrhythmia region according to the signal of the positioning sensor 4.

[0097] The display module is configured to display the pushing distance of the radio frequency ablation assembly 3 and the process of radio frequency ablation.

[0098] The processing module specifically comprises:

[0099] The preset radio frequency ablation expansion range and the pushing distance of the radio frequency ablation assembly 3 are matched with the current arrhythmia region information, the adjustment expansion range of the preset radio frequency ablation expansion range is determined, and the expansion range of the ablation electrode 32 required by the current arrhythmia region is determined, and the expansion range of the ablation electrode 32 required by the current arrhythmia region is defined as the expansion range information.

[0100] The preset radio frequency ablation component 3 is matched with the advancing distance and the expansion range information, the advancing distance corresponding to the expansion range information is determined, and the advancing distance corresponding to the expansion range information is defined as the advancing distance information.

[0101] The ablation electrode 32 is extended into the arrhythmia region and is advanced according to the advancing distance information, and the radio frequency ablation treatment is performed on the arrhythmia region.

[0102] In this embodiment, the expansion range is adjusted to T:

[0103]

[0104] Wherein, T is the adjustment expansion range of the preset radio frequency ablation range, β s is the arrhythmia region size correction coefficient, γ t is the heart tissue thickness correction coefficient, min(γ) is the minimum value of the heart tissue thickness, max(γ) is the maximum value of the heart tissue thickness, δ c is the electrode contact condition correction coefficient, ε is the electrode contact error, θ m is the real-time monitoring data correction coefficient, α1 is the correction weight of the arrhythmia region size correction coefficient, α2 is the correction weight of the heart tissue thickness correction coefficient, α3 is the correction weight of the electrode contact condition correction coefficient, and α4 is the correction weight of the real-time monitoring data correction coefficient. The sum of the weights of the arrhythmia region size correction coefficient, the heart tissue thickness correction coefficient, the electrode contact condition correction coefficient, and the real-time monitoring data correction coefficient is 1.

[0105] In this embodiment, when the adjustment expansion range of the preset radio frequency ablation range is positive, the preset radio frequency ablation range is expanded, when the adjustment expansion range is negative, the preset radio frequency ablation range is reduced, and when the adjustment expansion range is 0, the preset radio frequency ablation range does not need to be adjusted.

[0106] In this embodiment, when the arrhythmia region size correction coefficient is positive, the expansion range increases; when the heart tissue thickness correction coefficient is positive, the expansion range decreases; when the electrode contact condition correction coefficient is positive, the expansion range increases; and when the real-time monitoring data correction coefficient is positive, the expansion range increases.

[0107] In this embodiment, after the expansion range information is adjusted, the advancing distance information of the catheter may change or may not change.

[0108] The beneficial effects of the above technical scheme are: by calculating the adjustment expansion range, the expansion range of the ablation electrode 32 required by the current arrhythmia region is adjusted, which can make the determined expansion range information more accurate, thereby more accurately adjusting the advance distance information, and making the radiofrequency ablation treatment more efficient and accurate.

[0109] Working principle: when using the arrhythmia radiofrequency ablation catheter of the application, according to Figures 1-6 , the following steps are included:

[0110] S1: determine the expansion range of the ablation electrode 32 required by the current arrhythmia region and determine the advance distance corresponding to the expansion range information;

[0111] S2: extend the ablation electrode 32 into the arrhythmia region and advance according to the advance distance information to perform radiofrequency ablation treatment on the arrhythmia region;

[0112] S3: when the positioning sensor 4 positions the ablation electrode 32 to the arrhythmia region, stop advancing and use the pressure sensor 33 to monitor the abutting pressure of the ablation electrode 32 and the heart tissue in real time;

[0113] S4: adjust the abutting pressure of the ablation electrode 32 and the heart tissue according to the monitoring result to ensure that the abutting pressure of the ablation electrode 32 and the heart tissue is always within the standard pressure range;

[0114] S5: in the process of ablation, the first temperature sensor 34 and the second temperature sensor 36 respectively collect the temperature of the arrhythmia region and the temperature when the radiofrequency catheter 10 works;

[0115] S6: when the temperature collected by the first temperature sensor 34 and the second temperature sensor 36 is not within the set standard range, adjust the temperature of the arrhythmia region and the temperature when the radiofrequency catheter 10 works accordingly.

[0116] In summary, the heart arrhythmia radiofrequency ablation catheter of the present application can monitor the ablation electrode 32 and the heart tissue in real time through the pressure sensor 33, and can perform pressure relief and pressure increase on the balloon 31 according to the ablation electrode 32 and the heart tissue in real time, so as to ensure that the ablation electrode 32 and the heart tissue are always in the standard pressure range, avoid incomplete ablation due to insufficient pressure, or heart perforation caused by excessive pressure, and can collect the temperature of the arrhythmia area and the temperature of the radiofrequency catheter 10 in operation through the first temperature sensor 34 and the second temperature sensor 36, and can feed back the temperature of the arrhythmia area and the working temperature of the radiofrequency catheter 10 in real time, so as to timely adjust when the monitored real-time temperature is not in the standard temperature range, reduce the complications such as carbonization and steam burst, and further ensure the safety of the operation, and through real-time monitoring of the contact force between the catheter and the arrhythmia area, in combination with the radiofrequency energy parameters (such as power and ablation time), the energy release can be dynamically adjusted to ensure that the ablation range and depth meet the expectations, avoid excessive or insufficient damage, higher contact force and appropriate extension of the ablation time can promote the formation of transmural injury and improve the elimination efficiency of abnormal electrical physiological pathways, the pressure data can reflect the fitting degree of the catheter and the tissue, in combination with the radiofrequency parameter optimization (such as power adjustment and impedance monitoring), the ablation target point can be more accurately positioned, the success rate of the operation is improved, the real-time feedback of the pressure data helps to avoid excessive compression of the heart by the catheter, reduces the risk of heart perforation, blood vessel injury and the like, at the same time, accurate regulation of the energy parameters (such as limiting single-point ablation power) can prevent thermal injury of the surrounding tissues (such as esophagus and phrenic nerve), and the cooperative analysis of the pressure and energy parameters can evaluate the stability of the ablation injury, reduce the secondary operation demand caused by incomplete ablation or recurrence, for example, through monitoring of the basic impedance change and the injury volume, the formation effect of chronic injury can be predicted, in combination with the pressure data, the radiofrequency parameters can be quickly adjusted to reduce the number of invalid discharges, improve the ablation efficiency, and thus shorten the overall operation time.

[0117] It should be noted that the relational terms herein such as first and second and the like are used only to differentiate one entity or operation from another, and do not necessarily require or imply that any such actual relationship or order exists between or among the entities or operations. Also, the terms "comprising", "including", or any other variant thereof are intended to cover non-exclusive inclusion, so that processes, methods, articles, or equipment including a series of elements not only include those elements, but also include other elements not specifically listed or inherent to such processes, methods, articles, or equipment.

[0118] Although the embodiments of the present application have been shown and described, it will be understood by those skilled in the art that various changes, modifications, substitutions and variations can be made thereto without departing from the principles and spirit of the present application.

Claims

1. A radiofrequency ablation catheter for arrhythmia, comprising a control handle (1) and an ablation catheter body (2), characterized in that, The control handle (1) is fixed on the outside of the ablation catheter body (2), the radiofrequency ablation component (3) is sleeved on the outer periphery of the ablation catheter body (2), the top of the radiofrequency ablation component (3) is provided with a positioning sensor (4), the positioning sensor (4) is fixed on the tip (6), the lower part of the positioning sensor (4) is provided with a reference electrode (5), the control handle (1) is provided with a radiofrequency catheter (10), and the outside of the radiofrequency catheter (10) is provided with a temperature control component (9). The radio frequency conduit (10) is provided with a radio frequency cable (13) and an inlet pipe (14). The radio frequency cable (13) is connected to the ablation electrode (32), and the inlet pipe (14) is connected to the distal end (37). The pressure sensor (33), the first temperature sensor (34), and the second temperature sensor (36) are connected to the analysis system (7) through the sensor cable (11). The ablation electrode (32), the imaging element (35), and the positioning sensor (4) are connected to the radio frequency system (8) through the radio frequency cable (13). Radio frequency system (8), including: The processing module is used to determine the expansion range of the ablation electrode (32) required for the current arrhythmia area and the corresponding advancement distance of the expansion range information, and to control the radiofrequency ablation component (3) to advance according to the advancement distance; The processing module specifically includes: The preset radiofrequency ablation expansion range and the advance distance of the radiofrequency ablation component (3) are matched with the current arrhythmia area to determine the adjustment expansion range of the preset radiofrequency ablation expansion range, thereby determining the expansion range of the ablation electrode (32) required for the current arrhythmia area, and defining the expansion range of the ablation electrode (32) required for the current arrhythmia area as expansion range information. Match the preset advance distance and expansion range information of the radiofrequency ablation component (3) to determine the advance distance corresponding to the expansion range information, and define the advance distance corresponding to the expansion range information as the advance distance information; The ablation electrode (32) is inserted into the arrhythmia area and advanced according to the advancement distance information to perform radiofrequency ablation treatment on the arrhythmia area; The adjustment range is T: ； Where T represents the adjustment and expansion range of the preset radiofrequency ablation range. This is a correction factor for the size of the arrhythmia region. This is a correction factor for heart tissue thickness. This represents the minimum thickness of the heart tissue. This represents the maximum thickness of the heart tissue. This is a correction factor for electrode contact conditions. This is due to electrode contact error. To correct the data in real time, The corrected weights are the correction factors for the size correction coefficient of the arrhythmia region. The correction weight for the heart tissue thickness correction factor. The correction weight for the electrode contact condition correction factor. To monitor the correction weights of data correction coefficients in real time, the correction weights of the arrhythmia region size correction coefficient are as follows: Correction weight of the heart tissue thickness correction factor Correction weight of electrode contact condition correction factor Correction weights for real-time monitoring data correction coefficients The sum of their weights is 1; When the adjustment range of the preset radiofrequency ablation range is a positive number, the preset radiofrequency ablation range is expanded; when the adjustment range is a negative number, the preset radiofrequency ablation range is shrunk; when the adjustment range is 0, the preset radiofrequency ablation range does not need to be adjusted. When the correction factor for the size of the arrhythmia region is positive, the expansion range increases; when the correction factor for the thickness of the heart tissue is positive, the expansion range decreases; when the correction factor for electrode contact is positive, the expansion range increases; when the correction factor for real-time monitoring data is positive, the expansion range increases.

2. The radiofrequency ablation catheter for arrhythmia according to claim 1, characterized in that: The radiofrequency ablation assembly (3) includes a balloon (31), ablation electrodes (32), a pressure sensor (33), a first temperature sensor (34), a contrast agent (35), a second temperature sensor (36), and a distal end (37). Three sets of ablation electrodes (32) are equidistantly arranged on the outer side of the balloon (31) along the longitudinal axis of the balloon (31). The ablation electrodes (32) are connected to the radiofrequency cable (13), and a pressure sensor (33) and a first temperature sensor (34) are arranged between each set of ablation electrodes (32). The distal end (37) extends into the balloon (31), and a contrast agent (35) and a second temperature sensor (36) are arranged on the distal end (37). An air inlet (38) and a pressure relief valve (39) are provided at the bottom of the balloon (31), and the air inlet (38) is connected to the inflation tube (12).

3. The radiofrequency ablation catheter for arrhythmia according to claim 2, characterized in that: The temperature control component (9) includes a cold water tank (91), a heating tube (92) and a water outlet pipe (93). The cold water tank (91) is located inside the control handle (1). The water outlet pipe (93) is located on the side of the cold water tank (91). The water inlet pipe (94) is located on the top of the cold water tank (91). The heating tube (92) is located at the bottom of the cold water tank (91). An electric heating wire is located inside the heating tube (92).

4. The radiofrequency ablation catheter for arrhythmia according to claim 1, characterized in that: The analysis system (7) includes: The temperature acquisition module is used to acquire the temperature of the arrhythmia area and the temperature of the radiofrequency catheter (10) during operation using the first temperature sensor (34) and the second temperature sensor (36), respectively. The pressure acquisition module is used to acquire the contact pressure between the ablation electrode (32) and the heart tissue in real time using the pressure sensor (33); The analysis module is used to analyze the data collected by the temperature acquisition module and the pressure acquisition module, and adjust the temperature and pressure of radiofrequency ablation based on the analysis results.

5. The radiofrequency ablation catheter for arrhythmia according to claim 4, characterized in that: The analysis module includes: Set a standard temperature range for the radio frequency (RF) region. When the temperature exceeds the set standard temperature range for the RF region, reduce the RF power. At the same time, cold water is injected into the cold water tank (91) through the water inlet pipe (94) to reduce the operating temperature of the radio frequency conduit (10); When the temperature is lower than the set standard temperature range of the radio frequency area, the power of the radio frequency is increased, and the radio frequency conduit (10) is heated by the heating tube (92); Set a standard range of pressure between the ablation electrode (32) and the heart tissue. When the pressure between the ablation electrode (32) and the heart tissue exceeds the set standard range, control the pressure relief valve (39) to relieve pressure on the balloon (31) and reduce the pressure between the ablation electrode (32) and the heart tissue. When the contact pressure between the ablation electrode (32) and the heart tissue is lower than the set standard value range, the balloon (31) is inflated to increase the contact pressure between the ablation electrode (32) and the heart tissue; Pressure data and radiofrequency energy parameters are recorded synchronously to analyze the tissue Joule heating efficiency and thermal conductivity under different pressure values. Based on the tissue Joule heating efficiency and thermal conductivity under different pressure values, the damage to cardiac tissue during ablation is determined.

6. The radiofrequency ablation catheter for arrhythmia according to claim 4, characterized in that: The analysis module also includes: The pressure data of the catheter and the radio frequency energy parameters are recorded synchronously, and the pressure data is classified according to the pressure range to obtain a classification data table; Extract the radio frequency energy parameters corresponding to the same pressure range from the classification data table to obtain the radio frequency energy parameter table for each pressure range. Determine whether the timing deviation between the timestamp of the radio frequency energy parameter in the radio frequency energy parameter table and the timestamp of the corresponding pressure data is greater than the timing deviation corresponding to the preset radio frequency accuracy; If there is a timing deviation corresponding to a timestamp that is greater than the timing deviation corresponding to the preset RF precision, then it is determined that there is an error in the current RF energy parameter, and the RF energy parameter with the error is removed to obtain the optimized RF energy parameter table; Based on the radio frequency energy parameters in the optimized radio frequency energy parameter table, the optimized radio frequency energy parameters corresponding to the current pressure range are obtained. By combining the optimized radio frequency energy parameters corresponding to each pressure range, the optimized radio frequency energy parameters under different pressure values ​​are obtained. The efficiency of tissue Joule heat generation under different pressure values ​​was determined based on Joule's law. By combining relevant images and real-time surgical data of the target patient, a model of the patient's heart tissue is constructed, thereby using a pre-set simulation scheme to determine thermal damage parameters related to thermal conduction characteristics; Based on the correlation between thermal damage parameters and pressure, a pressure-damage relationship curve is obtained, and damage progression is predicted based on the trend of the curve. Based on the damage prediction results and the corresponding tissue Joule heating efficiency, the damage status of the target patient's cardiac tissue during radiofrequency ablation under different pressure values ​​is obtained, thereby adjusting the temperature and pressure data of radiofrequency ablation in real time.

7. The radiofrequency ablation catheter for arrhythmia according to claim 1, characterized in that: The radio frequency system (8) also includes: The positioning module is used to receive the signal from the positioning sensor (4) and obtain the positioning information of the tip (6) of the ablation electrode (32) inserted into the arrhythmia area based on the signal from the positioning sensor (4). The display module is used to display the advance distance of the radiofrequency ablation component (3) and the radiofrequency ablation process.

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