Personalized arrhythmia radiofrequency ablation system based on intelligent data analysis

Abstract

The invention discloses a personalized arrhythmia radiofrequency ablation system based on intelligent data analysis, and the system comprises a pressure stimulation module which is configured to apply periodic mechanical pressure stimulation to a specific anatomical site of a heart through an ablation catheter, the contact force range of the pressure stimulation is 5-10 g, and the frequency is 1-3 Hz; the autonomic nerve state recognition module is used for collecting heart rate change data of the patient after pressure stimulation in real time, and when the absolute value of the heart rate change exceeds 15% of a base line, it is judged that the patient enters an autonomic nerve sensitive window phase; the dynamic ablation strategy generation module is used for dynamically adjusting a radio frequency energy release mode and an ablation target priority according to the autonomic nerve sensitive window phase type, the sympathetic dominant type or the parasympathetic dominant type; according to the invention, by taking'neural interference conversion-dynamic energy adaptation-intelligent marking verification 'as a core, all-round breakthrough is realized from technical principle, clinical effect to application cost, and an accurate, safe and popular innovative scheme is provided for arrhythmia treatment.

Description

Technical Field

[0001] The present invention belongs to the field of medical devices, and specifically 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: Uncontrollable autonomic nerve interference: Traditional surgical methods cannot quantitatively measure the influence of sympathetic / parasympathetic nerves on ablation targets in real time. During the operation, arrhythmia mutations 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 prolonging 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.

[0003] Defects of static mapping systems: Mainstream three-dimensional mapping systems rely on preoperative or static mapping data. Catheter displacement caused by respiration and heartbeat during the operation needs 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 contact force and changes in intracavitary pressure, resulting in an enlarged mapping error in complex cases (such as structural abnormalities after cardiac surgery).

[0004] 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 the sympathetic nerve is activated, myocardial metabolism increases, and carbonization is likely to occur at the same power (incidence rate is about 12%); while when the parasympathetic nerve dominates, the heat diffusion efficiency decreases, resulting in incomplete transmurality (incidence rate is about 18%). Although individual technologies have tried power regulation (such as temperature feedback), the response delay (>3 seconds) is difficult to match the real-time physiological state.

[0005] 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 relapses 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.

[0006] Bottlenecks in operation complexity and safety: Existing technologies highly rely on the experience of operators. The learning curve for complex atrial fibrillation ablation exceeds 50 cases. Due to expensive equipment and lack of training resources in primary hospitals, it is difficult to carry out high-difficulty surgeries. In addition, there is insufficient real-time monitoring of contact force overload (>40 g) and over-temperature (>50 °C), leading to risks of perforation and thrombosis. Summary of the Invention

[0007] The objective of the present invention is to provide a personalized arrhythmia radiofrequency ablation system based on intelligent data analysis. The present invention takes "nerve interference conversion - dynamic energy adaptation - intelligent mapping verification" as the core, achieving all-round breakthroughs from technical principles, clinical effects to application costs, and providing an accurate, safe and popular innovative solution for the treatment of arrhythmia.

[0008] The technical solution adopted by the present invention is as follows: 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, the contact force range of the pressure stimulation being 5 - 10 g and the frequency being 1 - 3 Hz; An autonomic nerve state recognition module: real-time collecting 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; A dynamic ablation strategy generation module: dynamically adjusting the radiofrequency energy release mode and the ablation target priority according to the type of the autonomic nerve sensitive window period, whether it is sympathetic dominant or parasympathetic dominant; A closed-loop verification module: after ablation is completed, triggering local electrical conduction verification through secondary pressure stimulation, and calculating the voltage attenuation rate and the activation delay time of the ablation area.

[0009] Among them, 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 ostium, offset 3 - 5 mm backward to the posterior wall.

[0010] Among them, the dynamic ablation strategy generation module includes: 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 s / point; 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.

[0011] Among them, 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, the duty cycle is automatically adjusted from 1:1 to 1:3; When the impedance fluctuation range < 2 Ω lasts for 10 s, the continuous radiofrequency mode is restored.

[0012] Among them, the autonomic nerve state recognition module further includes: A 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 by >20% and is accompanied by a ST segment elevation of 0.1 mV in an upward slope, it is determined as a state of overactivation of the vagus nerve; A heart rate variability (HRV) calculation unit, which evaluates the sympathetic / parasympathetic balance index based on the standard deviation of the R-R interval (SDNN).

[0013] Among them, the system further includes a dynamic three-dimensional mapping compensation subsystem, and the subsystem: After each pressure stimulation, it collects catheter displacement data and corrects the electroanatomical mapping coordinates. The compensation formula is: ΔX = k1*(F·cosθ) + k2*(dP / dt); Among them: ΔX: the catheter displacement compensation amount (unit: mm); k1: the contact force compensation coefficient, with a value range of 0.12 - 0.18 mm / (g·Hz); k2: the pressure change compensation coefficient, with a value range of 0.05 - 0.10 mm / (mmHg / s); F: the measured value of the catheter contact force (unit: g); θ: the angle between the catheter axis and the normal direction of the myocardial surface (unit: radian); dP / dt: the instantaneous change rate of the intracardiac pressure (unit: mmHg / s).

[0014] Among them, the verification criteria of the closed-loop verification module include: Voltage attenuation rate determination: the local bipolar voltage after ablation <0.15 mV and a decrease of ≥80% compared to the baseline; 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 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.

[0015] A usage method based on the system includes the steps: S1. Apply a 2 Hz periodic pressure stimulation in the Bachmann bundle area of the right atrium for 3 respiratory cycles; S2. When it is detected that the heart rate decreases by >20%, complete continuous ablation of the pulmonary vein vestibule within the parasympathetic window period; S3. After stopping the stimulation, inject 6 mg of adenosine intravenously to expose the sympathetic sensitive target and perform pulsed ablation; S4. Apply a verification pressure stimulation every 5 mm along the ablation line to confirm that the voltage attenuation and conduction block meet the standards.

[0016] Among them, the sympathetic sensitive target identification described in step S3 includes: Locate the origin of the premature beats induced by adenosine, and screen the targets that meet the following characteristics: The duration of the local fractionated electrogram > 50 ms; The advance amount of the activation time > 30 ms; The rate of change of the voltage gradient > 0.3 mV / mm.

[0017] A computer-readable storage medium stores a control program for implementing the system, and the program includes: A pressure-heart rate coupling analysis algorithm, configured according to the formula: Ablation efficacy coefficient = 1 + 0.5 * (|ΔHR| / HR_base); Where: Ablation efficacy coefficient: the magnification factor of the actual action depth of the radiofrequency energy; ΔHR: the absolute value of the heart rate change before and after the pressure stimulation (unit: beats per minute); HR_base: the average baseline heart rate within 5 seconds before the pressure stimulation (unit: beats per minute); The calculation of the ablation efficacy coefficient further satisfies the constraint conditions: When HR_base < 50 beats per minute, forcefully lock the ablation efficacy coefficient ≤ 1.2; When HR_base > 120 beats per minute, use the dynamic heart rate normalization formula: Ablation efficacy coefficient = 1 + 0.3 * (|ΔHR| / (HR_base^0.7)).

[0018] To sum up, due to the adoption of the above technical solutions, the beneficial effects of the present invention are: Through the pressure stimulation module and the autonomic nerve state recognition module, the present invention first converts 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, the catheter displacement error caused by breathing and heartbeat is corrected through a three-dimensional mapping compensation algorithm, which is significantly better than traditional mapping systems.

[0019] 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 electrogram 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 drug injection for vagal reflex, making the incidence of serious complications (such as cardiac tamponade) approach 0%.

[0020] 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, greatly shortening the doctor training cycle. The hardware reuses existing catheters and mapping devices 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.

[0021] The present invention takes "nerve interference conversion - dynamic energy adaptation - intelligent mapping verification" as the core, achieving all-round breakthroughs from technical principles, clinical effects to application costs, and providing an accurate, safe and popularizable innovative solution for the treatment of arrhythmia. BRIEF DESCRIPTION OF THE DRAWINGS

[0022] Figure 1 It is a working schematic diagram of the arrhythmia radiofrequency ablation system of the present invention. DETAILED DESCRIPTION OF THE EMBODIMENTS

[0023] 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 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.

[0024] See Figure 1 , the present invention relates to a personalized arrhythmia radiofrequency ablation system based on intelligent data analysis, including: 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 is 5 - 10 g, and the frequency is 1 - 3 Hz; 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 input is heart rate variability (HRV) and QRS wave morphology. The output is the sympathetic / parasympathetic activity index (range of 0 - 1).

[0025] 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, sympathetic dominant type or parasympathetic dominant type; the input is the autonomic nerve state, real-time impedance, and temperature; the output is the dynamically adjusted power mode and ablation time.

[0026] Closed-loop verification module: after ablation is completed, local electrical conduction verification is triggered through secondary pressure stimulation, and the voltage attenuation rate and excitation delay time of the ablation area are calculated.

[0027] The pressure stimulation module includes a pressure stimulation catheter, a multimodal signal processor, and a radiofrequency energy generator; 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 is a nitinol catheter body, 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.

[0028] The input signals of the multimodal signal processor are electrocardiogram signals (lead II + intracardiac electrogram, sampling rate 1 kHz) and mechanical signals (contact force, catheter displacement, sampling rate 500 Hz). The output signals are to display the autonomic nerve state (sympathetic / parasympathetic) and the thermal map of the ablation target in real time.

[0029] The radiofrequency energy generator has the following modes: Continuous mode: power 10 - 50 W, temperature control accuracy ±1°C.

[0030] Pulse mode: frequency 50 Hz, duty cycle 1:3, power 5 - 10 W.

[0031] The safety mechanism is to automatically cut off the energy when the impedance suddenly rises (>5 Ω / s) or the temperature >50°C.

[0032] Furthermore, 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 from the sinoatrial node; The projection area of the Marshall ligament in the left atrium, coordinates: 10 - 15 mm above the coronary sinus ostium, offset 3 - 5 mm towards the posterior wall.

[0033] Furthermore, the dynamic ablation strategy generation module includes: When in the parasympathetic-dominant window period, use the continuous radiofrequency mode, set the power to 30 - 35 W, and extend the ablation duration to 25 - 30 seconds per point; 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 reduce the power to 5 - 10 W.

[0034] Furthermore, 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 seconds, resume the continuous radiofrequency mode.

[0035] Furthermore, the autonomic nerve state recognition module further includes: QRS complex 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 by more than 20% and is accompanied by an upward-sloping ST segment elevation of 0.1 mV, it is determined to be a state of excessive vagus nerve activation; Heart rate variability (HRV) calculation unit, which evaluates the sympathetic / parasympathetic balance index based on the standard deviation of the R-R interval (SDNN).

[0036] Furthermore, the system further includes a dynamic three-dimensional mapping compensation subsystem, which: After each pressure stimulation, it collects catheter displacement data and corrects the electroanatomical mapping coordinates. The compensation formula is: ΔX = k1*(F·cosθ) + k2*(dP / dt); Where: ΔX: Catheter displacement compensation amount (unit: mm); k1: Contact force compensation coefficient, with a value range of 0.12 - 0.18 mm / (g·Hz); k2: Pressure change compensation coefficient, with a value range of 0.05 - 0.10 mm / (mmHg / s); F: Measured value of the 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).

[0037] The input of the three-dimensional mapping compensation subsystem is catheter displacement and respiratory movement data. The output is the corrected electroanatomical mapping coordinates (error < 0.5 mm).

[0038] Furthermore, the verification criteria of the closed-loop verification module include: Voltage decay rate determination: The local bipolar voltage after ablation < 0.15 mV and a decrease of ≥ 80% compared to the baseline; Conduction block determination: When pacing synchronously on both sides of the ablation line, the conduction delay time > 120 ms; Recurrence pacing protection: Under isoproterenol drug provocation, the heart rate is increased to > 100 beats per minute by intravenous injection. If the difference in the refractory periods of the myocardium on both sides of the ablation line > 30 ms, it indicates that the ablation line effectively blocks electrical conduction and can reduce the risk of postoperative arrhythmia recurrence.

[0039] A method of using the system includes the steps of: S1. Apply a 2 Hz periodic pressure stimulation to the Bachmann bundle area of the right atrium for 3 respiratory cycles; S2. When it is detected that the heart rate decreases by more than 20%, continuous ablation of the pulmonary vein vestibule is completed within the parasympathetic window period; S3. After stopping the stimulation, inject 6 mg of adenosine intravenously to expose the sympathetic sensitive target and perform pulsed ablation; S4. Apply a confirmatory pressure stimulation every 5 mm along the ablation line to confirm that the voltage decay and conduction block reach the standard.

[0040] Further, the sympathetic sensitive target identification described in step S3 includes: Locate the origin of the premature beats induced by adenosine and screen the targets that meet the following characteristics: The duration of the local fractionated electrogram > 50 ms; The advance of the activation time > 30 ms; The rate of change of the voltage gradient > 0.3 mV / mm.

[0041] A computer-readable storage medium stores a control program for implementing the system, and the program includes: A pressure-heart rate coupling analysis algorithm configured according to the formula: Ablation efficacy coefficient = 1 + 0.5*(|ΔHR| / HR_base); Where: Ablation efficacy coefficient: The magnification factor of the actual action depth of the radiofrequency energy; ΔHR: The absolute value of the heart rate change before and after the pressure stimulation (unit: beats per minute); HR_base: The average baseline heart rate within 5 seconds before the pressure stimulation (unit: beats per minute); The calculation of the ablation efficacy coefficient further satisfies the constraint conditions: When HR_base < 50 beats per minute, forcefully lock the ablation efficacy coefficient ≤ 1.2; When HR_base > 120 beats per minute, use the dynamic heart rate normalization formula: Ablation efficacy coefficient = 1 + 0.3*(|ΔHR| / (HR_base^0.7)).

[0042] The operation process of the system of the present invention includes the following steps: Step 1: Catheter insertion and initial mapping Doctor's operation: Insert a pressure stimulation catheter into the right atrium through the femoral vein, and under the guidance of X-ray, position the catheter tip to the Bachmann bundle area (anatomical landmark: the muscular elevation on the anterior wall of 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).

[0043] System response: Real-time collect the electrocardiogram of lead II and the intracardiac electrogram (the filtered signal is transmitted to the multi-modal processor). The three-dimensional mapping system generates an initial heart model (accuracy ±2 mm).

[0044] Step 2: Autonomic nerve state activation and determination Doctor operation: Press the "Pressure Stimulation" button on the catheter handle to initiate 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 where the patient's heart rate drops from 80 beats per minute to 62 beats per minute (ΔHR = -22.5%).

[0045] System response: Parasympathetic index = (22.5 / 80)*100 × 0.6 + (ST segment integral 0.12 mV·s) × 0.4 = 0.81 (threshold > 0.7 is judged as the parasympathetic window); A blue window pops up on the screen: "Parasympathetic activation, it is recommended to start pulmonary vein isolation". The "safe ablation area" (blue highlight) of the pulmonary vein vestibule is marked in the 3D model.

[0046] Step 3: Dynamic energy ablation Doctor 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, the screen shows a green stable sign).

[0047] System operation: Power dynamic adjustment: 1. The power adjustment formula during the parasympathetic window period is: P cont =P base *(1 + α*∣ΔHR∣ / HR base ), where P cont : The actual power in the 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).

[0048] 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, actually executed for 20 seconds).

[0049] 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).

[0050] Doctor operation feedback: After 20 seconds of ablation, the screen shows "Transmural compliance reached", and the energy release automatically stops.

[0051] Step 4: Stress exposure and pulsed ablation 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 superior pulmonary vein (frequency 32 beats per minute).

[0052] System response: Autonomic nerve determination: Sympathetic index = (R-wave slope 2.8 mV / s × 0.7) + (ST segment depression 0.06 mV × 0.3) = 0.75 (threshold > 0.6 is determined as the sympathetic window).

[0053] Interface prompt: The screen turns red and warns: "Sympathetic sensitive area detected, high-frequency fragmented potential found!" The three-dimensional model marks the gap of the left superior pulmonary vein as the red target point.

[0054] Doctor's operation: Move the catheter to the target point and switch to the pulse ablation mode (press the "Pulse" button). Step on the ablation pedal and maintain a contact force of 6 g.

[0055] System operation: 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).

[0056] Effect feedback: After 60 seconds of ablation, the high-frequency premature beats disappear, and the local voltage drops from 1.2 mV to 0.08 mV.

[0057] Step 5: Closed-loop verification and additional points Doctor's operation: Apply a verification pressure stimulation 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 start synchronous pacing (cycle length 600 ms).

[0058] System operation: Voltage attenuation verification: The system automatically compares the voltages 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%).

[0059] Conduction block test: The conduction time of the left pacing signal T_left = 320 ms, and the right one _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."

[0060] Step 6: Winding up and safety monitoring 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.

[0061] System operation: Post-operative report generation: Automatically generate surgical reports, including the number of ablation points (28 points), total energy release time (45 minutes), and transmural compliance rate (96%).

[0062] Abnormal event recording: Record 2 intraoperative occurrences of excessive contact force (12g, 13g), automatically triggering catheter retraction.

[0063] 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.

[0064] 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 principle 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: include: A pressure stimulation module: configured to apply periodic mechanical pressure stimulation to a specific anatomical site of the heart through an ablation catheter, wherein the contact force of the pressure stimulation ranges from 5 to 10 g and the frequency ranges from 1 to 3 Hz; Autonomic nerve state recognition module: collects the patient's heart rate change data after pressure stimulation in real time. When the absolute value of the heart rate change exceeds the baseline by 15%, it is determined to have entered the autonomic nerve sensitive window period; 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, sympathetic dominant type or parasympathetic dominant type; Closed-loop verification module: After ablation is completed, local electrical conduction verification is triggered by secondary pressure stimulation to calculate the voltage decay rate and excitation delay time of the ablation area.

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

3. The system according to claim 1, characterized in that The dynamic ablation strategy generation module includes: When in the parasympathetic dominant window period, continuous radiofrequency mode was used, the power was set to 30-35W, and the ablation duration was extended to 25-30 seconds / point; When in the sympathetic dominant window period, switch to pulsed radio frequency mode, configure 50Hz high-frequency pulses, single pulse width 80-120ms, and reduce the power to 5-10W.

4. The system according to claim 3, 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 is greater than 5Ω / s, the duty cycle is automatically adjusted from 1:1 to 1:3; When the impedance fluctuation range is less than 2Ω for 10 seconds, the continuous RF mode is restored.

5. The system according to claim 1, characterized in that The autonomic nervous system state recognition module further comprises: The QRS wave morphology analysis unit after pressure stimulation is configured to detect the change in the amplitude of the R wave of the lead II electrocardiogram. When the amplitude decreases by more than 20% and is accompanied by an upward sloping ST segment elevation of 0.1 mV, it is determined to be a state of excessive activation of the vagus nerve; Heart rate variability (HRV) calculation unit, which evaluates the sympathetic / parasympathetic balance index based on the standard deviation of RR intervals (SDNN).

6. The system according to claim 1, characterized in that It also includes a dynamic three-dimensional mapping compensation subsystem, wherein: After each pressure stimulation, the catheter displacement data is collected and the electroanatomical mapping coordinates are corrected. The compensation formula is: ΔX = k1*(F·cosθ) + k2*(dP / dt); Where: ΔX: catheter displacement compensation (unit: mm); k1: contact force compensation coefficient, ranging from 0.12-0.18 mm / (g·Hz); k2: pressure change compensation coefficient, ranging from 0.05-0.10 mm / (mmHg / s); F: catheter contact force measurement value (unit: g); θ: the angle between the catheter axis and the normal of the myocardial surface (unit: radians); dP / dt: the instantaneous rate of change of intracardiac pressure (unit: mmHg / s).

7. The system according to claim 1, characterized in that The verification criteria of the closed-loop verification module include: Determination of voltage decay rate: local bipolar voltage after ablation <0.15 mV and decreased by ≥80% compared with the baseline; Conduction block determination: when synchronous pacing is performed on both sides of the ablation line, the conduction delay time is greater than 120ms; Recurrent pacing protection: Under the stimulation of isoproterenol, the heart rate is increased to >100 beats / min through intravenous injection. If the difference in refractory period of the myocardium on both sides of the ablation line is >30ms, it indicates that the ablation line has effectively blocked electrical conduction, which can reduce the risk of recurrence of arrhythmias after surgery.

8. A method for using the system according to any one of claims 1 to 7, characterized in that: Includes steps: S1. Apply 2 Hz periodic pressure stimulation to the Bachmann bundle area of ​​the right atrium for 3 respiratory cycles; S2. When a heart rate drop of >20% is detected, complete continuous ablation of the pulmonary vein vestibule within the parasympathetic window; S3. After stopping stimulation, 6 mg of adenosine was injected intravenously to expose the sympathetic sensitive targets and perform pulse ablation. S4. Apply confirmatory pressure stimulation every 5 mm along the ablation line to confirm that voltage attenuation and conduction block meet the standards.

9. The method according to claim 8, characterized in that The identification of sympathetic sensitive targets in step S3 includes: Locate the origin of adenosine-induced premature beats and screen for targets that meet the following characteristics: The duration of local fragmentation potential is >50ms; Excitation time advance> 30ms; The voltage gradient change rate is >0.3mV / mm.

10. A computer-readable storage medium storing a control program for implementing the system according to any one of claims 1 to 7, characterized in that: The program comprises: The pressure-heart rate coupling analysis algorithm is configured according to the formula: Ablation effectiveness coefficient = 1 + 0.5*(|ΔHR| / HR_base); Wherein: Ablation effectiveness coefficient: the magnification of the actual depth of action of radiofrequency energy; ΔHR: the absolute value of the heart rate change before and after pressure stimulation (unit: beats / minute); HR_base: the average baseline heart rate within 5 seconds before pressure stimulation (unit: beats / minute); The calculation of the ablation effectiveness coefficient further satisfies the constraint condition: When HR_base < 50 times / min, the forced lock ablation effectiveness coefficient is ≤ 1.2; When HR_base>120 beats / minute, the dynamic heart rate normalization formula is used: Ablation effectiveness coefficient = 1 + 0.3*(|ΔHR| / (HR_base^0.7)).

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