Personalized Arrhythmia Radiofrequency Ablation System Based on Intelligent Data Analysis

Abstract

The present invention discloses a personalized arrhythmia radiofrequency ablation system based on intelligent data analysis, comprising: a pressure stimulation module configured to apply periodic mechanical pressure stimulation to specific anatomical sites of the heart through an ablation catheter, wherein the contact force range of the pressure stimulation is 5-10 g and the frequency is 1-3 Hz; an autonomic nerve state recognition module configured to collect in real time the data of the patient's heart rate change after the pressure stimulation, and determine that the autonomic nerve sensitive window period is entered when the absolute value of the heart rate change exceeds 15% of the baseline; a dynamic ablation strategy generation module configured to dynamically adjust the radiofrequency energy release mode and the ablation target priority according to the type of the autonomic nerve sensitive window period, i.e., sympathetic dominant type or parasympathetic dominant type; the present invention takes "nerve interference conversion - dynamic energy adaptation - intelligent mapping verification" as the core, and achieves all-round breakthroughs from technical principles, clinical effects to application costs, providing an accurate, safe and popular innovative solution for arrhythmia treatment.

Description

Technical Field

[0001] The present invention belongs to the field of medical devices, and particularly relates to a personalized arrhythmia radiofrequency ablation system based on intelligent data analysis. Background Art

[0002] In the field of arrhythmia radiofrequency ablation, the existing technologies mainly rely on anatomical mapping and fixed energy release modes, and have the following significant defects:

[0003] Uncontrollable autonomic nerve interference: Traditional surgical procedures cannot quantify the influence of sympathetic / parasympathetic nerves on ablation targets in real time. During the operation, sudden changes in heart rhythm caused by patient stress or vagal reflex often lead to target drift (error up to 2-3 mm), forcing doctors to repeatedly adjust the catheter position and prolong the operation time (an average increase of 20-30 minutes). Existing solutions such as pretreatment with beta-blocker drugs can partially inhibit nerve activity, but are prone to complications such as hypotension or bradycardia, and cannot dynamically adapt to intraoperative changes.

[0004] Defects of static mapping systems: Mainstream three-dimensional mapping systems rely on preoperative or static mapping data. Displacements of catheters caused by respiration and heartbeat during the operation need to be manually corrected, which is cumbersome and lacks precision. Existing dynamic compensation algorithms (such as respiratory gating) only correct a single dimension of movement and do not integrate changes in contact force and intracavitary pressure, resulting in an enlarged mapping error in complex cases (such as abnormal cardiac structure after surgery).

[0005] Single energy release mode: Existing radiofrequency generators use continuous ablation at a fixed power (usually 30-40 W) and cannot adapt to dynamic changes in tissue impedance. For example, when sympathetic activation occurs, myocardial metabolism increases, and carbonization is likely to occur at the same power (incidence rate is about 12%); while when the parasympathetic is dominant, the heat diffusion efficiency decreases, resulting in incomplete transmurality (incidence rate is about 18%). Although there are individual technologies that attempt power regulation (such as based on temperature feedback), the response delay (>3 seconds) is difficult to match the real-time physiological state.

[0006] Insufficient postoperative verification: Traditional methods rely on a single standard of local voltage drop to verify the ablation effect, ignoring the risks of conduction delay and recovery of excitability conduction. Research shows that about 25% of postoperative recurrences are due to residual slow conduction paths (voltage meets the standard but the delay is insufficient), and existing technologies lack an integrated solution for provocation tests (such as adenosine / isoproterenol) and multi-index verification.

[0007] Bottlenecks in operation complexity and safety: Existing technologies highly rely on the experience of operators, and the learning curve for complex atrial fibrillation ablation exceeds 50 cases. Grassroots hospitals are difficult to carry out high-difficulty surgeries due to expensive equipment and lack of training resources. In addition, there is insufficient real-time monitoring of contact force overload (>40 g) and over-temperature (>50 °C), resulting in risks of perforation and thrombosis. Summary of the Invention

[0008] The object of the present invention is: The present invention aims to provide a personalized arrhythmia radiofrequency ablation system based on intelligent data analysis. With "nerve interference conversion - dynamic energy adaptation - intelligent mapping verification" as the core, it achieves all-round breakthroughs from technical principles, clinical effects to application costs, providing an accurate, safe and popular innovative solution for the treatment of arrhythmia.

[0009] The technical solution adopted by the present invention is as follows:

[0010] A personalized arrhythmia radiofrequency ablation system based on intelligent data analysis, comprising:

[0011] A pressure stimulation module: configured to apply periodic mechanical pressure stimulation to specific anatomical sites of the heart through an ablation catheter, the contact force range of the pressure stimulation being 5 - 10 g and the frequency being 1 - 3 Hz;

[0012] An autonomic nerve state recognition module: real-time collects the patient's heart rate change data after pressure stimulation, and when the absolute value of the heart rate change exceeds 15% of the baseline, it is determined to enter the autonomic nerve sensitive window period;

[0013] A dynamic ablation strategy generation module: dynamically adjusts the radiofrequency energy release mode and the ablation target priority according to the type of the autonomic nerve sensitive window period, sympathetic dominant type or parasympathetic dominant type;

[0014] A closed-loop verification module: after ablation is completed, triggers local electrical conduction verification through secondary pressure stimulation, and calculates the voltage attenuation rate and the excitation delay time of the ablation area.

[0015] Among them, the specific anatomical sites of the pressure stimulation module include:

[0016] The Bachmann bundle area of the right atrium, coordinates: the anterior wall at the junction of the superior vena cava and the right atrium, 5 - 8 mm away from the sinoatrial node;

[0017] The projection area of the Marshall ligament of the left atrium, coordinates: 10 - 15 mm above the coronary sinus orifice, offset 3 - 5 mm towards the posterior wall.

[0018] Among them, the dynamic ablation strategy generation module includes:

[0019] When in the parasympathetic dominant window period, a continuous radiofrequency mode is adopted, the power is set to 30 - 35 W, and the ablation duration is extended to 25 - 30 seconds / point;

[0020] When in the sympathetic dominant window period, it is switched to the pulsed radiofrequency mode, configured with a 50 Hz high-frequency pulse, the single pulse width is 80 - 120 ms, and the power is reduced to 5 - 10 W.

[0021] Among them, the duty cycle of the pulsed radiofrequency mode is dynamically adjusted according to the real-time tissue impedance:

[0022] When the impedance rise rate > 5 Ω / s, the duty cycle is automatically adjusted from 1:1 to 1:3;

[0023] When the impedance fluctuation range < 2 Ω lasts for 10 seconds, the continuous radiofrequency mode is restored.

[0024] Among them, the autonomic nerve state recognition module further includes:

[0025] QRS wave morphology analysis unit after pressure stimulation, configured to detect the change in the amplitude of the R wave in lead II of the electrocardiogram. When the amplitude decreases > 20% and is accompanied by an upward-sloping elevation of the ST segment by 0.1 mV, it is determined as the state of overactivation of the vagus nerve;

[0026] Heart rate variability (HRV) calculation unit, which evaluates the sympathetic / parasympathetic balance index based on the standard deviation of the R-R interval (SDNN).

[0027] Among them, the system further includes a dynamic three-dimensional mapping compensation subsystem, and the subsystem:

[0028] After each pressure stimulation, catheter displacement data is collected and the electroanatomical mapping coordinates are corrected. The compensation formula is:

[0029] ;

[0030] Where: ΔX: catheter displacement compensation amount (unit: mm); k1: contact force compensation coefficient, with a value range of 0.12 - 0.18 mm / g; k2: pressure change compensation coefficient, with a value range of 0.05 - 0.10 mm / (mmHg / s); F: catheter contact force measurement value (unit: g); θ: angle between the catheter axis and the normal of the myocardial surface (unit: radian); dP / dt: instantaneous change rate of intracardiac pressure (unit: mmHg / s).

[0031] Among them, the verification criteria of the closed-loop verification module include:

[0032] Voltage attenuation rate determination: After ablation, the local bipolar voltage < 0.15 mV and the decrease from the baseline ≥ 80%;

[0033] Conduction block determination: When pacing synchronously on both sides of the ablation line, the conduction delay time > 120 ms;

[0034] Recurrent pacing protection: Under the provocation of isoproterenol drug, the heart rate is increased to > 100 beats per minute by intravenous injection. If the refractory period difference between the myocardium on both sides of the ablation line > 30 ms, it indicates that the ablation line effectively blocks the electrical conduction and can reduce the risk of postoperative arrhythmia recurrence.

[0035] A method of using the system, comprising the steps:

[0036] S1. Apply a 2Hz periodic pressure stimulation to the Bachmann bundle area of the right atrium for 3 respiratory cycles.

[0037] S2. When the detected heart rate decrease > 20%, complete continuous ablation of the pulmonary vein vestibule within the parasympathetic window period.

[0038] S3. After stopping the stimulation, inject 6mg of adenosine intravenously to expose the sympathetic sensitive target and perform pulsed ablation.

[0039] S4. Apply a verification pressure stimulation every 5mm along the ablation line to confirm that the voltage attenuation and conduction block reach the standard.

[0040] Among them, the identification of the sympathetic sensitive target in step S3 includes:

[0041] Locate the origin point of premature beats induced by adenosine and screen the targets that meet the following characteristics:

[0042] The duration of local fractionated electrograms > 50ms;

[0043] The advance amount of activation time > 30ms;

[0044] The rate of change of voltage gradient > 0.3mV / mm.

[0045] A computer-readable storage medium stores a control program for implementing the system, and the program includes:

[0046] A pressure-heart rate coupling analysis algorithm, configured according to the formula:

[0047] ;

[0048] Where: ablation efficacy coefficient: the magnification of the actual depth of action of radiofrequency energy; ΔHR: the absolute value of the change in heart rate before and after pressure stimulation (unit: beats per minute); HR_base: the average baseline heart rate within 5 seconds before pressure stimulation (unit: beats per minute).

[0049] The calculation of the ablation efficacy coefficient further satisfies the constraint conditions:

[0050] When HR_base < 50 beats per minute, forcefully lock the ablation efficacy coefficient ≤ 1.2;

[0051] When HR_base > 120 beats per minute, use the dynamic heart rate normalization formula:

[0052] .

[0053] In summary, due to the adoption of the above technical solutions, the beneficial effects of the present invention are as follows:

[0054] Through the pressure stimulation module and the autonomic nerve state recognition module, the present invention for the first time transforms the uncontrollable intraoperative autonomic nerve interference into a quantifiable operation window. Periodic mechanical stimulation targets and activates specific cardiac plexuses, combines QRS wave morphology and heart rate variability analysis to determine the sympathetic / parasympathetic dominant state in real time, and dynamically matches continuous radiofrequency and pulsed radiofrequency modes. Compared with traditional fixed-energy ablation, the transmural injury efficiency is significantly improved, and the carbonization risk is significantly reduced. At the same time, through the three-dimensional mapping compensation algorithm to correct the catheter displacement error caused by breathing and heartbeat, it is significantly better than traditional mapping systems.

[0055] The closed-loop verification module of the present invention adopts dual criteria of voltage decay rate and conduction delay to ensure the integrity of the ablation line and the blocking effect. For complex lesions (such as high-frequency micro-reentry), through adenosine induction and fractionated potential screening, the dynamic target detection rate is significantly improved, and the postoperative recurrence rate is significantly reduced. The intelligent safety mechanism realizes full-process protection such as automatic retraction when the contact force exceeds the limit and injection of drugs for vagal reflex, making the incidence of serious complications (such as cardiac tamponade) approach 0%.

[0056] The system of the present invention provides a guided operation process. The pressure stimulation, energy switching, and verification steps are all completed through interface prompts, significantly shortening the doctor training cycle. The hardware reuses existing catheters and mapping equipment, and only requires software upgrade to support, with low hospital transformation costs. The dynamic algorithm adapts to patients with extreme heart rates (such as hyperthyroidism / sick sinus syndrome), and complex ablation can also be carried out in primary hospitals, promoting the popularization of technology.

[0057] With "nerve interference transformation - dynamic energy adaptation - intelligent mapping verification" as the core, the present invention achieves all-round breakthroughs from technical principles, clinical effects to application costs, providing an accurate, safe and popularizable innovative solution for the treatment of arrhythmias. BRIEF DESCRIPTION OF THE DRAWINGS

[0058] Figure 1 It is a working schematic diagram of the arrhythmia radiofrequency ablation system of the present invention. DETAILED DESCRIPTION OF THE EMBODIMENTS

[0059] In order to make the objectives, technical solutions and advantages of the present invention clearer, the present invention will be further described in detail below with reference to the accompanying drawings and embodiments. It should be understood that the specific embodiments described herein are only used to explain the present invention and are not used to limit the present invention.

[0060] See Figure 1 , this invention relates to a personalized arrhythmia radiofrequency ablation system based on intelligent data analysis, including:

[0061] Pressure Stimulation Module: Configured to apply periodic mechanical pressure stimulation to specific anatomical sites of the heart through an ablation catheter, with the contact force range of the pressure stimulation being 5 - 10 g and the frequency being 1 - 3 Hz;

[0062] Autonomic Nerve State Recognition Module: Real-time collects the patient's heart rate change data after pressure stimulation. When the absolute value of the heart rate change exceeds 15% of the baseline, it is determined to enter the autonomic nerve sensitive window period; the inputs are heart rate variability (HRV) and QRS wave morphology. The output is the sympathetic / parasympathetic activity index (in the range of 0 - 1).

[0063] Dynamic Ablation Strategy Generation Module: Dynamically adjusts the radiofrequency energy release mode and ablation target priority according to the type of the autonomic nerve sensitive window period, whether it is sympathetic-dominant or parasympathetic-dominant; the inputs are autonomic nerve state, real-time impedance, and temperature; the output is to dynamically adjust the power mode and ablation time.

[0064] Closed-loop Verification Module: After ablation is completed, triggers local electrical conduction verification through secondary pressure stimulation, and calculates the voltage attenuation rate and activation delay time of the ablation area.

[0065] The pressure stimulation module includes a pressure stimulation catheter, a multi-modal signal processor, and a radiofrequency energy generator;

[0066] The pressure stimulation catheter has an outer diameter of 2.33 mm (7F), a tip length of 3 mm, and a bending radius ≤ 1.5 mm. The material of the catheter body is nitinol, and the tip integrates a MEMS piezoresistive sensor (range 0 - 50 g, accuracy ±0.5 g). Its function is to apply periodic mechanical pressure (5 - 10 g, frequency 2 Hz) to activate the autonomic nerve reflex.

[0067] The input signals of the multi-modal signal processor are electrocardiogram signals (lead Ⅱ + intracardiac electrogram, sampling rate 1 kHz). Mechanical signals (contact force, catheter displacement, sampling rate 500 Hz). The output signals are to real-time display the autonomic nerve state (sympathetic / parasympathetic) and the ablation target thermal map.

[0068] The modes of the radiofrequency energy generator are:

[0069] Continuous mode: Power 10 - 50 W, temperature control accuracy ±1℃.

[0070] Pulse mode: Frequency 50 Hz, duty cycle 1:3, power 5 - 10 W.

[0071] The safety mechanism is to automatically cut off the energy when the impedance suddenly rises (>5 Ω / s) or the temperature > 50℃.

[0072] Furthermore, the specific anatomical sites of the pressure stimulation module include:

[0073] Right atrial Bachmann bundle area, coordinates: anterior wall at the junction of the superior vena cava and the right atrium, 5-8 mm from the sinoatrial node;

[0074] Projection area of the left atrial Marshall ligament, coordinates: 10-15 mm above the coronary sinus ostium, offset 3-5 mm towards the posterior wall.

[0075] Further, the dynamic ablation strategy generation module includes:

[0076] When in the parasympathetic-dominant window period, the continuous radiofrequency mode is adopted, the power is set to 30-35 W, and the ablation duration is extended to 25-30 seconds per point;

[0077] When in the sympathetic-dominant window period, switch to the pulsed radiofrequency mode, configure 50 Hz high-frequency pulses, single pulse width 80-120 ms, and the power is reduced to 5-10 W.

[0078] Further, the duty cycle of the pulsed radiofrequency mode is dynamically adjusted according to the real-time tissue impedance:

[0079] When the impedance rise rate > 5 Ω / s, automatically adjust the duty cycle from 1:1 to 1:3;

[0080] When the impedance fluctuation range < 2 Ω lasts for 10 seconds, resume the continuous radiofrequency mode.

[0081] Further, the autonomic nerve state recognition module further includes:

[0082] QRS wave morphology analysis unit after pressure stimulation, configured to detect the change in the amplitude of the R wave in lead II of the electrocardiogram. When the amplitude decreases > 20% and is accompanied by an upward-sloping elevation of the ST segment by 0.1 mV, it is determined as the state of excessive vagus nerve activation;

[0083] Heart rate variability (HRV) calculation unit, which evaluates the sympathetic / parasympathetic balance index based on the standard deviation of the R-R interval (SDNN).

[0084] Further, the system also includes a dynamic three-dimensional mapping compensation subsystem, and the subsystem:

[0085] After each pressure stimulation, collect catheter displacement data and correct the electroanatomical mapping coordinates. The compensation formula is:

[0086] ;

[0087] Where: ΔX: catheter displacement compensation (unit: mm); k1: contact force compensation coefficient, with a value range of 0.12 - 0.18 mm / g; k2: pressure change compensation coefficient, with a value range of 0.05 - 0.10 mm / (mmHg / s); F: measured value of catheter contact force (unit: g); θ: angle between the catheter axis and the normal of the myocardial surface (unit: radian); dP / dt: instantaneous change rate of intracardiac pressure (unit: mmHg / s).

[0088] The input of the three-dimensional mapping compensation subsystem is catheter displacement and respiratory motion data. The output is the corrected electroanatomical mapping coordinates (error < 0.5 mm).

[0089] Furthermore, the verification criteria of the closed-loop verification module include:

[0090] Judgment of voltage decay rate: After ablation, the local bipolar voltage < 0.15 mV and the decrease from the baseline is ≥ 80%;

[0091] Judgment of conduction block: When pacing synchronously on both sides of the ablation line, the conduction delay time > 120 ms;

[0092] Recovery pacing protection: Under the provocation of isoproterenol, the heart rate is increased to > 100 beats per minute by intravenous injection. If the refractory period difference of the myocardium on both sides of the ablation line > 30 ms, it indicates that the ablation line effectively blocks the electrical conduction and can reduce the risk of postoperative arrhythmia recurrence.

[0093] A usage method based on the system includes the steps:

[0094] S1. Apply a 2 Hz periodic pressure stimulation to the Bachmann bundle area of the right atrium for 3 respiratory cycles;

[0095] S2. When it is detected that the heart rate drops > 20%, complete continuous ablation of the pulmonary vein vestibule within the parasympathetic window period;

[0096] S3. After stopping the stimulation, inject 6 mg of adenosine intravenously to expose the sympathetic sensitive target and perform pulsed ablation;

[0097] S4. Apply a verification pressure stimulation every 5 mm along the ablation line to confirm that the voltage decay and conduction block meet the standards.

[0098] Furthermore, the identification of the sympathetic sensitive target in step S3 includes:

[0099] Locate the origin point of premature beats induced by adenosine and screen the targets that meet the following characteristics:

[0100] The duration of local fragmented electrograms > 50 ms;

[0101] The advance amount of activation time > 30 ms;

[0102] The rate of change of voltage gradient > 0.3 mV / mm.

[0103] A computer-readable storage medium stores a control program for implementing the system, and the program includes:

[0104] A pressure-heart rate coupling analysis algorithm configured according to the formula:

[0105] ;

[0106] where: Ablation efficacy coefficient: the magnification factor of the actual action depth of radiofrequency energy; ΔHR: the absolute value of the change in heart rate before and after pressure stimulation (unit: beats per minute); HR_base: the average baseline heart rate within 5 seconds before pressure stimulation (unit: beats per minute);

[0107] The calculation of the ablation efficacy coefficient further satisfies the constraint condition:

[0108] When HR_base < 50 beats per minute, the ablation efficacy coefficient is forced to be locked ≤ 1.2;

[0109] When HR_base > 120 beats per minute, the dynamic heart rate normalization formula is adopted:

[0110] .

[0111] The operation process of the system of the present invention includes the following steps:

[0112] Step 1: Catheter placement and initial mapping

[0113] Doctor's operation: Insert a pressure stimulation catheter into the right atrium through the femoral vein, and position the catheter tip at the Bachmann bundle area under X-ray guidance (anatomical landmark: the muscular elevation on the anterior wall at the junction of the superior vena cava and the right atrium). Gently touch the myocardial surface to confirm that the contact force is stable at 5 - 7 g (the green contact force ring is displayed on the screen).

[0114] System response: Real-time collect the electrocardiogram of lead II and intracardiac electrograms (the filtered signals are transmitted to the multi-modal processor). The three-dimensional mapping system generates an initial cardiac model (accuracy ±2 mm).

[0115] Step 2: Autonomic nerve state activation and determination

[0116] Doctor's operation: Press the "pressure stimulation" button on the catheter handle to start 2 Hz periodic pressing (press gently 2 times per second, contact force 7 g, for 15 seconds). Observe the change in heart rate on the screen. Take the example of the patient's heart rate dropping from 80 beats per minute to 62 beats per minute (ΔHR = -22.5%).

[0117] System response: ; A blue window pops up on the screen: "Parasympathetic activation, it is recommended to start pulmonary vein isolation". The "safe ablation area" (highlighted in blue) of the pulmonary vein vestibule is marked in the 3D model.

[0118] Step 3: Dynamic energy ablation

[0119] Doctor's operation: During the parasympathetic window period, move the catheter to the left pulmonary vein ostium and step on the ablation pedal. Keep the catheter stable (contact force 5 - 8 g, and a green stable sign is displayed on the screen).

[0120] System operation:

[0121] Dynamic power adjustment: 1. The power adjustment formula during the parasympathetic window period is:

[0122] P cont =P base *(1 + α * ∣ΔHR∣ / HR base ), where P cont : The actual power in continuous radiofrequency mode; P base : The reference power (default value: 30 W); ΔHR: The absolute value of the change in heart rate before and after pressure stimulation (unit: beats per minute); HR base : The average basal heart rate in the 5 seconds before stimulation (unit: beats per minute); α: The adjustment coefficient (default value: 0.2, calibrated through experiments).

[0123] So the calculation is as follows: Power P = 30 + 0.2 * (22.5 - 15) = 31.5 W; Ablation time T = 25 + 0.5 * (40 - 62) = 14 seconds (because the heart rate is lower than 60 bpm, triggering the lower limit protection, and actually executed for 20 seconds).

[0124] Real-time monitoring: The impedance linearly drops from 120 Ω to 85 Ω (indicating the formation of transmural injury). The temperature stabilizes at 43 °C (no over-temperature protection is triggered).

[0125] Doctor's operation feedback: After 20 seconds of ablation, the screen shows "transmural compliance", and the energy release automatically stops.

[0126] Step 4: Stress exposure and pulsed ablation

[0127] Doctor's operation: Stop the pressure stimulation, and the patient's heart rate rebounds to 85 beats per minute. Intravenous injection of 6 mg of adenosine, and observe the intracardiac electrogram: High-frequency premature beats appear in the left upper pulmonary vein (frequency 32 beats per minute).

[0128] System response:

[0129] Autonomic nerve determination: Sympathetic index = (R-wave slope of 2.8 mV / s × 0.7) + (ST-segment depression of 0.06 mV × 0.3) = 0.75 (a threshold > 0.6 is determined as the sympathetic window).

[0130] Interface prompt: The screen turns red with a warning: "Sympathetic sensitive area detected, high-frequency fragmented potentials found!" The left upper pulmonary vein gap is marked as a red target in the 3D model.

[0131] Doctor's operation: Move the catheter to the target point and switch to the pulsed ablation mode (press the "Pulse" button). Step on the ablation pedal and maintain a contact force of 6 g.

[0132] System operation:

[0133] Energy release: 50 Hz pulsed radiofrequency (0.1 s on / 0.3 s off), power 8 W. The real-time impedance fluctuation range is ±3 Ω (indicating no carbonization).

[0134] Effect feedback: After 60 seconds of ablation, high-frequency premature beats disappear, and the local voltage drops from 1.2 mV to 0.08 mV.

[0135] Step 5: Closed-loop verification and additional points

[0136] Doctor's operation: Apply a verification pressure stimulus every 5 mm along the ablation line (contact force 10 g, duration 2 s). Place mapping catheters on both sides of the ablation line and initiate synchronous pacing (cycle length 600 ms).

[0137] System operation:

[0138] Voltage attenuation verification: The system automatically compares the voltage before and after ablation and calculates the attenuation rate: Attenuation rate = (1.0 mV - 0.15 mV) / 1.0 mV × 100% = 85% (the passing threshold > 80%).

[0139] Conduction block test: The left pacing signal conduction time T_left = 320 ms, and the right side _right = 465 ms. The conduction delay Δt = 145 ms (the passing threshold > 120 ms). Interface prompt: The screen shows a green "√" sign: "The ablation line is complete, no additional points are needed."

[0140] Step 6: Completion and safety monitoring

[0141] Doctor's operation: Withdraw the catheter to the inferior vena cava, check for no bleeding or perforation. Stop the isoproterenol infusion and observe that the patient's heart rate stabilizes at 75 beats per minute.

[0142] System operation:

[0143] Post-operative report generation: Automatically generate a surgical report, including the number of ablation points (28 points), total energy release time (45 minutes), and transmural success rate (96%).

[0144] Abnormal event recording: Record 2 intraoperative occurrences of excessive contact force (12g, 13g), which automatically trigger catheter retraction.

[0145] The system of the present invention transforms complex autonomic nerve regulation into a standardized operation through a closed-loop process of "pressing stimulation - algorithm decision - dynamic ablation - real-time verification". Doctors only need to follow the on-screen prompts to press the catheter and switch modes, and the system automatically completes target determination, energy optimization, and safety monitoring, significantly reducing the learning curve and achieving "foolproof" precise ablation.

[0146] The above are only the preferred embodiments of the present invention and are not intended to limit the present invention. Any modifications, equivalent replacements, and improvements made within the spirit and principles of the present invention shall be included within the protection scope of the present invention.

Claims

1. A personalized arrhythmia radiofrequency ablation system based on intelligent data analysis, characterized in that, Comprising: Pressure stimulation module: configured to apply periodic mechanical pressure stimulation to specific anatomical sites of the heart through an ablation catheter, the contact force range of the pressure stimulation being 5 - 10 g and the frequency being 1 - 3 Hz; Autonomic nerve state recognition module: real-time collect the patient's heart rate change data after pressure stimulation, and when the absolute value of the heart rate change exceeds 15% of the baseline, it is determined to enter the autonomic nerve sensitive window period; Dynamic ablation strategy generation module: dynamically adjust the radiofrequency energy release mode and ablation target priority according to whether the autonomic nerve sensitive window period type is sympathetic-dominant or parasympathetic-dominant; Closed-loop verification module: after ablation is completed, trigger local electrical conduction verification through secondary pressure stimulation, and calculate the voltage attenuation rate and activation delay time of the ablation area; The dynamic ablation strategy generation module includes: When in the parasympathetic-dominant window period, adopt a continuous radiofrequency mode, with the power set to 30 - 35 W and the ablation duration extended to 25 - 30 s / point; When in the sympathetic-dominant window period, switch to the pulsed radiofrequency mode, configure a 50 Hz high-frequency pulse, the single pulse width is 80 - 120 ms, and the power is reduced to 5 - 10 W; The verification criteria of the closed-loop verification module include: Voltage attenuation rate determination: the local bipolar voltage after ablation < 0.15 mV and the decrease compared to the baseline ≥ 80%; Conduction block determination: when pacing synchronously on both sides of the ablation line, the conduction delay time > 120 ms; Recurrence pacing protection: under the provocation of isoproterenol drug, the heart rate is increased to > 100 beats / min through intravenous injection. If the refractory period difference of the myocardium on both sides of the ablation line > 30 ms, it indicates that the ablation line effectively blocks the electrical conduction and can reduce the risk of postoperative arrhythmia recurrence.

2. The system according to claim 1, wherein The specific anatomical sites of the pressure stimulation module include: The Bachmann bundle area of the right atrium, coordinates: the anterior wall at the junction of the superior vena cava and the right atrium, 5 - 8 mm away from the sinoatrial node; The projection area of the Marshall ligament of the left atrium, coordinates: 10 - 15 mm above the coronary sinus orifice, offset 3 - 5 mm backward to the posterior wall.

3. The system according to claim 1, characterized in that, The duty cycle of the pulsed radiofrequency mode is dynamically adjusted according to the real-time tissue impedance: When the impedance rise rate > 5 Ω / s, automatically adjust the duty cycle from 1:1 to 1:3; When the impedance fluctuation range < 2 Ω lasts for 10 s, resume the continuous radiofrequency mode.

4. The system according to claim 1, wherein The autonomic nerve state recognition module further includes: QRS wave morphology analysis unit after pressure stimulation, configured to detect the change in the amplitude of the R wave in lead II of the electrocardiogram. When the amplitude decreases > 20% and is accompanied by an upward-sloping elevation of the ST segment by 0.1 mV, it is determined to be a state of overactivation of the vagus nerve; Heart rate variability (HRV) calculation unit, evaluating the sympathetic / parasympathetic balance index based on the standard deviation of the R - R interval (SDNN).

5. The system according to claim 1, wherein It further includes a dynamic three-dimensional mapping compensation subsystem, and the subsystem: After each pressure stimulation, collect catheter displacement data and correct the electroanatomical mapping coordinates, and the compensation formula is: ； Where: ΔX: catheter displacement compensation amount, unit: mm; k1: contact force compensation coefficient, value range 0.12 - 0.18 mm / g; k2: pressure change compensation coefficient, value range 0.05 - 0.10 mm / (mmHg / s); F: catheter contact force measurement value, unit: g; θ: angle between the catheter axis and the normal of the myocardial surface, unit: radian; dP / dt: instantaneous change rate of intracardiac pressure, unit: mmHg / s.

6. A computer-readable storage medium stores a control program for implementing the system according to any one of claims 1-5, characterized in that, The program includes: A pressure-heart rate coupling analysis algorithm configured according to the formula: ； Where: ablation efficacy coefficient: magnification factor of the actual action depth of radiofrequency energy; ΔHR: absolute value of the heart rate change before and after pressure stimulation, unit: beats per minute; HR_base: average baseline heart rate within 5 seconds before pressure stimulation, unit: beats per minute. The calculation of the ablation efficacy coefficient further satisfies the constraint condition: When HR_base < 50 beats per minute, force-lock the ablation efficacy coefficient ≤ 1.2; When HR_base > 120 beats per minute, use the dynamic heart rate normalization formula: 。

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