An epicardial pulsed electric field ablation electrode system and minimally invasive myocardial bridge release device

Abstract

The application belongs to the technical field of medical devices, and discloses an epicardial pulse electric field ablation electrode system and a minimally invasive myocardial bridge release device, which comprises an electrode main body, a directional segmented ablation electrode part, a lipid-sweeping wing, an electrocardiosynchronous module, an impedance monitoring module and a pulse generator. The directional segmented ablation electrode part comprises a plurality of electrode pieces arranged in segments along the length direction of the electrode main body and an insulating shielding layer arranged on the side of the electrode main body away from the myocardium. The electrode pieces are arranged on the side of the electrode main body facing the myocardium surface. The lipid-sweeping wing is arranged on the side of the electrode main body in an expandable manner. The impedance monitoring module is electrically connected with each electrode piece. The pulse generator is electrically connected with the directional segmented ablation electrode part, the electrocardiosynchronous module and the impedance monitoring module. The application integrates various technical means such as lipid sweeping, directional segmented ablation, electrocardiosynchronous triggering and impedance feedback protection, so that the deep myocardial bridge can be completely, safely and effectively released under minimally invasive conditions.

Description

Technical Field

[0001] This invention relates to the field of medical device technology, specifically to an epicardial pulsed electric field ablation electrode system and a minimally invasive myocardial bridging device. Background Technology

[0002] Myocardial bridging is a congenital anatomical abnormality of the coronary arteries, characterized by a segment of the coronary artery running beneath the myocardial fibers, with the bundle of myocardial fibers covering this segment called a myocardial bridging. During cardiac systole, myocardial bridging compresses the coronary artery, leading to restricted coronary blood flow and potentially causing angina, myocardial infarction, or even sudden death. Based on the depth of the myocardial bridging covering the coronary artery, it is classified into superficial (≤2mm) and deep (>2mm). Deep myocardial bridging, due to its thickness, length, and deep location, presents a greater challenge for clinical treatment.

[0003] In current techniques, the treatment of deep myocardial bridging mainly involves surgical myocardial bridging, which involves directly incising the myocardial bridge covering the coronary artery surface under direct vision to relieve compression. However, this procedure carries serious risks for deep myocardial bridging: when the myocardial bridge is too thick, it is difficult to completely remove it to the adventitia level, and residual compression after surgery can easily lead to symptom recurrence; deep myocardial bridging is tightly adhered to the adventitia of the coronary artery, and sharp dissection can easily cut into the coronary artery wall, causing coronary perforation or even cardiac rupture. In addition, although existing catheter-based intracoronary pulsed electric field ablation technology can apply an electric field from the inside of the vessel, the ablation depth is insufficient due to the vessel diameter, making it difficult to cover the entire thickness of deep myocardial bridging, and the electrode being located within the vessel lumen poses a risk of damaging the contralateral intima of the coronary artery.

[0004] Therefore, the existing technologies of surgical release are incomplete in removing deep myocardial bridges and are prone to damaging the coronary artery walls, while the transcatheter coronary pulsed electric field ablation technology has insufficient ablation depth and poses a risk of damaging the coronary intima. These problems urgently need to be solved. Summary of the Invention

[0005] The purpose of this invention is to provide an epicardial pulsed electric field ablation electrode system and a minimally invasive myocardial bridge release device. This invention can overcome the technical problems of surgical release surgery, such as incomplete removal of deep myocardial bridges and easy damage to the coronary artery wall, as well as the insufficient ablation depth and risk of damage to the coronary intima of catheter-directed intracoronary pulsed electric field ablation technology.

[0006] To achieve the above objectives, the technical solution adopted by the present invention is as follows: In a first aspect, the present invention provides an epicardial pulsed electric field ablation electrode system, comprising: The electrode body includes a soft shape at room temperature outside the body, and an unfolded shape that recovers under body temperature after being placed on the epicardium and is adapted to the course of the myocardial bridge along the coronary artery. The directional segmented ablation electrode includes a plurality of electrode plates arranged in segments along the length of the electrode body and an insulating shielding layer disposed on the side of the electrode body facing away from the myocardium. The electrode plates are disposed on the side of the electrode body facing the myocardial surface, and the insulating shielding layer is used to radiate the pulsed electric field unidirectionally toward the myocardium. The fat-sweeping wings are deployable and mounted on the side of the electrode body to physically separate the epicardial fat pad before the electrode body is placed, thereby exposing the myocardial surface. The ECG synchronization module is used to acquire the patient's ECG signal and generate a trigger signal during the diastolic phase of the heart based on the ECG signal. The impedance monitoring module is electrically connected to each electrode pad and is used to monitor the impedance of the myocardial tissue region corresponding to each electrode pad in real time. The pulse generator is electrically connected to the directional segmented ablation electrode section, the ECG synchronization module, and the impedance monitoring module. It is used to output a pulsed electric field during cardiac diastole based on the trigger signal of the ECG synchronization module, and to adjust the pulse output by impedance feedback or terminate the pulse output based on the monitoring results of the impedance monitoring module.

[0007] In some embodiments, the electrode body in both the flexible and unfolded forms is strip-shaped; The electrode body has a length of 30-50 mm and a width of 6-10 mm.

[0008] In some embodiments, the electrode body is made of nickel-titanium shape memory alloy, and the phase transition temperature of the nickel-titanium shape memory alloy is 32°C to 38°C.

[0009] In some embodiments, the electrode body is provided with an infusion channel extending along its length. The infusion port of the infusion channel is located at the end of the electrode body closer to the operator, and the outlet of the infusion channel is located at the end of the electrode body away from the operator and / or on the side of the electrode body. This is used to infuse the electrode body with cold physiological saline, thereby cooling the electrode body to below the phase transition temperature and restoring its soft shape.

[0010] In some embodiments, the number of electrode sheets is 3 to 8, and insulating silicone spacers are provided between adjacent electrode sheets; The fat-sweeping wings are nickel-titanium alloy sheets symmetrically arranged on both sides of the electrode body. They include a folded storage form at room temperature outside the body and a sweeping form that unfolds to both sides under the action of body temperature after being placed on the epicardium. The width of the sweeping form is greater than the width of the electrode body. The edge of the fat-sweeping wing has a blunt arc structure, and the surface of the fat-sweeping wing is provided with drainage holes to guide tissue fluid through during the fat-sweeping process and reduce the resistance of the sweeping.

[0011] In some embodiments, the ECG synchronization module includes an ECG acquisition unit and a trigger control unit. The ECG acquisition unit is provided with a three-lead electrode interface on the body surface or an epicardial electrode interface for acquiring the patient's ECG signal. The trigger control unit is electrically connected to the ECG acquisition unit and the pulse generator for detecting the ECG R wave and triggering the pulse generator to output a pulse after a delay of 200 to 400 milliseconds following the R wave.

[0012] In some embodiments, a positioning and mapping module is also included, which is electrically connected to each electrode pad, for acquiring epicardial electrocardiograms to identify the location and course of myocardial bridges.

[0013] In some embodiments, a pressure sensor electrically connected to the pulse generator is also included, integrated on the surface of the electrode body that contacts the myocardium, for real-time monitoring of the contact force between the electrode and the myocardium.

[0014] In some embodiments, a temperature sensor electrically connected to the pulse generator and integrated within the electrode body is also included for monitoring the electrode-tissue interface temperature.

[0015] In some embodiments, the number of pressure sensors matches the number of electrode pads, and the pressure sensors and electrode pads are alternately arranged on the side of the electrode body facing the myocardial surface; The pressure sensor has a monitoring range of 0–50 g.

[0016] Secondly, the present invention provides a minimally invasive myocardial bridging device, comprising a device body on which the above-mentioned epicardial pulsed electric field ablation system is installed.

[0017] The above technical solution has the following advantages or beneficial effects: This invention provides an epicardial pulsed electric field ablation electrode system. The electrode body adaptively reverts to an unfolded shape under body temperature, conforming to the course of the myocardial bridge along the coronary artery, achieving close contact between the electrode and the myocardial surface and solving the problem of incomplete surgical resection. A fat-scanning wing physically separates the epicardial fat pad before electrode placement, preventing the fat layer from attenuating the electric field and ensuring effective delivery of ablation energy to the entire layer of deep myocardial bridges, thus achieving sufficient ablation depth to cover the deep myocardial bridge and overcoming the shortcomings of insufficient ablation depth in endocardial techniques. An insulating shielding layer allows the pulsed electric field to radiate unidirectionally towards the myocardium, and combined with an ECG synchronization module that triggers pulse output during diastole, it avoids excessive ablation due to thickening of the myocardial bridge during systole, effectively protecting the coronary artery wall from damage. An impedance monitoring module monitors the tissue impedance of the corresponding area of ​​each electrode in real time and adjusts or terminates the pulse output based on impedance feedback, achieving automatic termination after myocardial ablation and preventing the pulsed electric field from continuing to act on the coronary artery wall. This system integrates fat removal, targeted ablation, ECG synchronization, and impedance feedback protection, enabling deep myocardial bridging to be completely, safely, and effectively released under minimally invasive conditions.

[0018] Secondly, this invention provides a minimally invasive myocardial bridging device that integrates the aforementioned epicardial pulsed electric field ablation electrode system into the device body, forming an integrated minimally invasive surgical platform that is convenient for surgeons to operate and manage during the operation. This device can be used to release myocardial bridging through a small intercostal incision, avoiding the trauma of median thoracotomy, reducing postoperative pain and the risk of complications, and shortening hospital stay. It provides a dedicated device solution for the treatment of deep myocardial bridging that combines minimal invasiveness, precision, and safety. Attached Figure Description

[0019] Figure 1 This is a schematic diagram of the epicardial pulsed electric field ablation electrode system according to an embodiment of the present invention; Figure 2 This is a schematic diagram of the system connection as shown in an embodiment of the present invention; Figure 3 This is a schematic diagram of the cross-sectional structure of the electrode body according to an embodiment of the present invention; Figure 4 This is a schematic diagram of the process of removing epicardial fat pads by the fat-sweeping wings according to an embodiment of the present invention, wherein (A) is a schematic diagram of the fat-sweeping wings in the folded and stored state, (B) is a schematic diagram of the fat-sweeping wings unfolded to the sweeping shape, and (C) is a schematic diagram of the fat pads being separated by pushing them along the surface of the myocardium. Figure 5 This is a schematic diagram of the bonding verification of a multi-channel pressure sensor according to an embodiment of the present invention, wherein (A) is a schematic diagram of the sensor layout of the electrode body contact surface, and (B) is a four-level force determination; Figure 6 This is a schematic diagram illustrating the principle of impedance monitoring for coronary artery protection in an embodiment of the present invention. Figure 7 This is a schematic diagram of the segmented sequential ablation strategy shown in an embodiment of the present invention; In all the accompanying drawings, the same reference numerals denote the same technical features, specifically: 1. Electrode body; 2. Electrode sheet; 3. Insulating shielding layer; 4. Grease sweeping wings. Detailed Implementation

[0020] In the following description, only certain exemplary embodiments are briefly described. As those skilled in the art will recognize, the described embodiments can be modified in various ways without departing from the spirit or scope of the invention. Therefore, the drawings and description are considered to be exemplary in nature and not restrictive.

[0021] In the description of this invention, it should be understood that the terms "center," "longitudinal," "lateral," "length," "width," "thickness," "upper," "lower," "front," "rear," "left," "right," "vertical," "horizontal," "top," "bottom," "inner," "outer," "clockwise," "counterclockwise," "axial," "radial," and "circumferential" indicate the orientation or positional relationship based on the orientation or positional relationship shown in the accompanying drawings. They are used only for the convenience of describing this invention and simplifying the description, and do not indicate or imply that the device or element referred to must have a specific orientation, or be constructed and operated in a specific orientation. Therefore, they should not be construed as limitations on this invention.

[0022] Furthermore, the terms "first" and "second" are used for descriptive purposes only and should not be construed as indicating or implying relative importance or implicitly specifying the number of indicated technical features. Thus, a feature defined as "first" or "second" may explicitly or implicitly include one or more of that feature. In the description of this invention, "a plurality of" means two or more, unless otherwise explicitly specified.

[0023] In this invention, unless otherwise explicitly specified and limited, the terms "installation," "connection," "linking," and "fixing," etc., should be interpreted broadly. For example, they can refer to a fixed connection, a detachable connection, or an integral part; they can refer to a mechanical connection, an electrical connection, or a communication connection; they can refer to a direct connection or an indirect connection through an intermediate medium; they can refer to the internal communication of two components or the interaction between two components. Those skilled in the art can understand the specific meaning of the above terms in this invention according to the specific circumstances.

[0024] In this invention, unless otherwise explicitly specified and limited, "above" or "below" the second feature can include direct contact between the first and second features, or contact between the first and second features through another feature between them. Furthermore, "above," "over," and "on top" of the second feature includes the first feature directly above or diagonally above the second feature, or simply indicates that the first feature is at a higher horizontal level than the second feature. "Below," "below," and "under" the second feature includes the first feature directly below or diagonally below the second feature, or simply indicates that the first feature is at a lower horizontal level than the second feature.

[0025] The technical solutions of the embodiments of the present invention will be clearly and completely described below with reference to the accompanying drawings. Obviously, the described embodiments are only some embodiments of the present invention, and not all embodiments. Based on the embodiments of the present invention, all other embodiments obtained by those skilled in the art without creative effort are within the scope of protection of the present invention.

[0026] Based on the above background, this application provides an epicardial pulsed electric field ablation electrode system and a minimally invasive myocardial bridging device. By placing the electrode body directly on the target location of the epicardium through a small intercostal incision, and combining various methods such as directional segmental ablation, physical fat removal, ECG synchronous triggering, and impedance monitoring, the aim is to apply an effective and safe pulsed electric field towards the myocardial bridge. This overcomes the technical problems of existing epicardial approaches, which make it difficult to safely and effectively perform deep myocardial bridge ablation due to fat pad obstruction, uncontrollable ablation depth under beating heart, and lack of coronary artery protection monitoring mechanisms.

[0027] Example 1: This embodiment provides an epicardial pulsed electric field ablation electrode system. See [link to documentation]. Figure 1 It includes an electrode body 1, a directional segmented ablation electrode section, a fat-sweeping wing 4, an electrocardiogram synchronization module, an impedance monitoring module, and a pulse generator.

[0028] In this embodiment, the electrode body 1 is configured to have a flexible shape at room temperature outside the body. This flexible shape facilitates insertion into the thoracic cavity and placement on the target area of ​​the epicardium by the surgeon through a small intercostal incision, using a minimally invasive technique. Once placed on the epicardium, the electrode body 1 automatically returns to its unfolded shape under the influence of body temperature. This unfolded shape conforms to the anatomical shape of the myocardial bridge along the coronary artery, ensuring that the electrode body 1 adheres to the myocardial tissue on the surface of the myocardial bridge along the direction of the coronary artery.

[0029] In this embodiment, a directional segmented ablation electrode is disposed on the electrode body 1 for applying a pulsed electric field to myocardial bridging tissue. Specifically, the directional segmented ablation electrode includes a plurality of electrode pads 2 arranged in segments along the length of the electrode body 1 and an insulating shielding layer 3 disposed on the side of the electrode body 1 facing away from the myocardium. The electrode pads 2 are disposed on the side of the electrode body 1 facing the myocardial surface and are used to generate a pulsed electric field after energization. The insulating shielding layer 3 is a polyimide or silicone film, and the insulating shielding layer 3 covers the side of the electrode body 1 facing away from the myocardium. Its function is to ensure that the pulsed electric field generated by the electrode pads 2 radiates unidirectionally towards the myocardium, thereby avoiding ineffective diffusion of electric field energy into non-target areas such as the pericardial cavity or pleural cavity, improving energy utilization efficiency and the targeting of ablation.

[0030] In this embodiment, the fat-scanning wings 4 are deployable and disposed on the side of the electrode body 1. Before the electrode body 1 is placed at the target location on the epicardium, the fat-scanning wings 4 are used to physically separate the fat pads covering the surface of the epicardium, thereby exposing the myocardium on the surface of the myocardial bridge. By removing the fat pads with the fat-scanning wings 4, the attenuation of the pulsed electric field and physical contact barrier by the adipose tissue can be effectively eliminated, ensuring that the subsequent ablation electrode pad 2 can achieve good contact with the myocardial tissue.

[0031] In this embodiment, the ECG synchronization module is used to acquire the patient's ECG signal. Upon identifying specific ECG signal characteristics, it can generate a trigger signal during diastole based on the ECG signal, ensuring that the release of the pulsed electric field occurs within a safe window of the cardiac cycle.

[0032] In this embodiment, see Figure 2 The impedance monitoring module is electrically connected to each electrode pad 2. This module is used to monitor the impedance value of the myocardial tissue region corresponding to each electrode pad 2 in real time during the ablation process. By analyzing the changes in impedance, the ablation status of the myocardial tissue in that region can be reflected in real time.

[0033] In this embodiment, the pulse generator is electrically connected to the directional segmented ablation electrode section, the ECG synchronization module, and the impedance monitoring module, respectively. The pulse generator receives the trigger signal generated by the ECG synchronization module and outputs a pulsed electric field to the electrode 2 only during diastole. Simultaneously, the pulse generator also receives the monitoring results from the impedance monitoring module and performs impedance feedback adjustment based on these results, or terminates pulse output when ablation is determined to be complete.

[0034] Through the above methods, the system of the present invention forms a complete closed loop from energy release and timing control to real-time monitoring and feedback regulation, providing a hardware foundation for achieving safe and effective myocardial bridge ablation.

[0035] Example 2: Based on Embodiment 1 above, this embodiment further describes the specific material, shape, size, phase change characteristics, and infusion channel structure of the electrode body 1.

[0036] In this embodiment, to achieve the characteristics of the electrode body being flexible at room temperature outside the body and adaptively unfolding at body temperature inside the body, the electrode body 1 is made of nickel-titanium shape memory alloy. Nickel-titanium shape memory alloy has shape memory effect and superelasticity, and its phase transformation temperature (i.e., the austenitic phase transformation end temperature Af) is set to 32℃~38℃. When the electrode body 1 is in an outside room temperature environment (usually about 25℃), its temperature is lower than the phase transformation temperature, and the alloy is in the martensitic state, exhibiting a flexible shape, which is convenient for the surgeon to flexibly manipulate and place through a small intercostal incision. When the electrode body 1 is placed at the target position on the epicardium, its temperature gradually rises to the human body temperature (about 37℃), reaching and exceeding the phase transformation temperature, and the alloy undergoes a martensitic to austenitic phase transformation, thereby automatically restoring to the preset unfolded shape.

[0037] In one specific embodiment, the electrode body 1 is strip-shaped in both its flexible and unfolded forms. The length of the electrode body 1 ranges from 30 to 50 mm, preferably 40 mm; the width ranges from 6 to 10 mm, preferably 8 mm. This strip-shaped design, with its above-mentioned dimensions, can match the anatomical dimensions of the myocardial bridge, ensuring effective coverage of the entire myocardial bridge; on the other hand, its moderate width facilitates positioning and adhesion on the surface of the heart.

[0038] To enable the electrode body 1 to revert to a soft form for withdrawal when necessary, in some embodiments, an infusion channel is provided along the length of the electrode body 1. The infusion port of the infusion channel is located at the end of the electrode body 1 closest to the operator (i.e., the proximal end), allowing the surgeon to connect a cold saline infusion source externally. The outlet of the infusion channel is located at the end of the electrode body 1 furthest from the operator (i.e., the distal end) and / or on the side of the electrode body 1. When the electrode needs to be withdrawn after the surgery, cold saline (e.g., 0–5°C) can be infused into the electrode body 1 through the infusion port. The cold saline flows out through the outlet of the infusion channel, rapidly cooling the electrode body 1 to below its phase transition temperature. The electrode body 1 then returns to a soft form, facilitating safe and painless withdrawal via a small intercostal incision.

[0039] In one optional embodiment of this invention, the electrode body 1 is unfolded into an arc-shaped strip. This arc design is intended to better match the physiological curvature of the heart surface in the region where the left anterior descending artery (LAD) runs, allowing the electrode body 1 to achieve a closer fit with the myocardial surface, thereby reducing contact resistance and improving energy transfer efficiency.

[0040] Example 3: Based on Embodiment 2 above, this embodiment further explains the structure, quantity, and arrangement of the electrode sheet 2 and the grease-sweeping blade 4, as well as the integration method and monitoring range of the pressure sensor.

[0041] In this embodiment, to achieve independent and controllable ablation of different regions of the myocardial bridge, the number of electrode pads 2 is 3 to 8, preferably 5. Each electrode pad 2 is arranged in segments along the length of the electrode body 1. Insulating silicone spacers are provided between adjacent electrode pads 2 to prevent short circuits or electric field interference between adjacent electrode pads 2, ensuring that each electrode pad 2 can operate independently. Each electrode pad 2 is independently wired and can be controlled via a selector switch on the handheld operating unit or an external control panel, allowing for individual or combined energization according to the actual length and shape of the myocardial bridge, thus flexibly adjusting the length of the ablation area. Each electrode pad 2 is connected to an independent monitoring channel of the impedance monitoring module, enabling independent real-time monitoring of impedance changes in the corresponding myocardial tissue region.

[0042] In this embodiment, the electrode pad 2 is made of platinum-iridium alloy, which has good biocompatibility and excellent conductivity, and can withstand the high-voltage instantaneous current during pulsed electric field ablation. Each electrode pad 2 measures approximately 8mm × 4mm × 0.3mm, and the insulating silicone spacer between adjacent electrode pads 2 is approximately 2mm. These dimensions and spacing ensure sufficient ablation area while also achieving a uniform electric field distribution, which is beneficial for forming a continuous and uniform ablation lesion zone.

[0043] In this embodiment, to effectively push aside the fat pads on the surface of the epicardium, two fat-sweeping wings 4 are symmetrically arranged on both sides of the electrode body 1. The fat-sweeping wings 4 are made of nickel-titanium alloy sheets and have two forms: one is a folded and stowed form at room temperature outside the body, which facilitates the entry of the electrode body 1 into the thoracic cavity through a small incision without adding extra volume; the other is a sweeping form that unfolds laterally under the influence of body temperature after being placed on the epicardium. In the sweeping form, the unfolded width of the fat-sweeping wings 4 is greater than the width of the electrode body 1, for example, it can unfold to a width of approximately 16 mm, thereby pushing the fat pads to the sides a sufficient distance, exposing a channel for the electrode sheet 2 to directly contact the myocardial surface.

[0044] In this embodiment, to prevent the fat-sweeping wings 4 from damaging the epicardium or myocardial surface during fat sweeping, the edges of the fat-sweeping wings 4 are designed with a blunt arc structure, for example, an arc radius of approximately 1 mm, thereby avoiding sharp edges from scratching the tissue. Furthermore, the surface of the fat-sweeping wings 4 is provided with drainage holes, the diameter of which is approximately 1 mm. During the sweeping process along the myocardial surface, the drainage holes guide the pushed-out tissue fluid through, thereby reducing fluid resistance during the sweeping process, making the operator's operation smoother, and also preventing traction damage to surrounding tissues due to excessive sweeping.

[0045] In this embodiment, to assess the contact state between the electrode and the myocardium in real time, the system also includes a pressure sensor electrically connected to a pulse generator. The pressure sensor is integrated into the surface of the electrode body 1 that contacts the myocardium. Its function is to monitor the contact force between the electrode body 1 and the myocardial tissue in real time.

[0046] In a preferred embodiment, the number of pressure sensors matches the number of electrode pads 2, and the pressure sensors and electrode pads 2 are alternately arranged on the same side of the electrode body 1 facing the myocardial surface. For example, five electrode pads 2 and five pressure sensors can be arranged alternately, or a pressure sensor can be placed between two adjacent electrode pads 2, thereby achieving distributed monitoring of the contact force at each point along the length of the electrode body 1.

[0047] In this embodiment, the pressure sensor is preferably a MEMS piezoresistive thin-film pressure sensor, which has the advantages of thinness, high sensitivity, and fast response. The monitoring range of the pressure sensor is set to 0–50g (equivalent to 0–490mN), with a resolution of not less than 0.5g, preferably 0.1g, and a sampling frequency of not less than 100Hz. This monitoring range covers various states from insufficient contact to excessive pressure, providing the operator with accurate force feedback.

[0048] In practical applications, when any pressure sensor detects a contact force <5g, the system can issue a prompt, informing the operator that the electrode adhesion in that area is insufficient and that the electrode position needs to be adjusted or appropriate pressure applied to ensure that the electric field can effectively penetrate the myocardial tissue. When any pressure sensor detects a contact force ≥20g or ≥30g, the system can issue a warning or emergency stop signal, indicating to the operator that the pressure is too high and that pressure reduction and adjustment are needed to avoid mechanical damage or blood flow obstruction caused by excessive compression of the myocardium. By comprehensively judging the situation through multiple pressure sensors, the system can effectively avoid the adhesion artifacts that may occur when relying solely on single-point pressure monitoring, thereby ensuring a reliable and comprehensive adhesion between the electrode and the myocardium.

[0049] Example 4: This embodiment, based on the above embodiment 3, further explains the specific implementation methods of the ECG synchronization module, the positioning and mapping module, the pressure sensor, and the temperature sensor.

[0050] Based on the above embodiments, considering that the thickness of the myocardial bridge changes significantly during systole and diastole—that is, the myocardial bridge thickens under pressure during systole and thins back during diastole—applying a pulsed electric field during systole could easily lead to excessive ablation depth due to the increased thickness of the myocardial bridge, thereby damaging the underlying coronary artery. Therefore, to achieve precise and safe ablation, the timing of pulse release needs to be precisely controlled.

[0051] In this embodiment, the ECG synchronization module includes an ECG acquisition unit and a trigger control unit. The ECG acquisition unit is equipped with a surface three-lead electrode interface or an epicardial electrode interface for acquiring the patient's ECG signals. In minimally invasive small-incision surgery, clear ECG signals can be obtained by attaching electrodes to the body surface or placing electrodes directly on the epicardium. The trigger control unit is electrically connected to the ECG acquisition unit and the pulse generator. The trigger control unit is used to detect the R wave in the ECG in real time, and after detecting the R wave, triggers the pulse generator to output a pulse according to a preset delay time. This delay time is set to ensure that the pulse output falls during the diastolic phase of the heart.

[0052] Specifically, the trigger control unit triggers the pulse generator to output a pulse 200–400 milliseconds after the R wave. Preferably, this delay time can be individually adjusted according to the patient's heart rate: 300 milliseconds for a heart rate of 60–80 beats / min; 250 milliseconds for a heart rate of 80–100 beats / min; and 200 milliseconds for a heart rate greater than 100 beats / min. Through this electrocardiographic synchronization mechanism, the pulsed electric field is released only during diastole, ensuring that the myocardial bridge is ablated within a relatively stable and thin window period. This results in controllable and consistent ablation depth, while avoiding the vulnerable period of the ventricles (T wave), reducing the risk of inducing arrhythmias.

[0053] In this embodiment, to locate the position and course of the myocardial bridge before ablation, the system also includes a localization and mapping module. The localization and mapping module is electrically connected to each electrode pad 2. Its working principle is to use the ablation electrode pad 2 as mapping electrodes to acquire an epicardial electrocardiogram (ECG) before ablation. Due to abnormal myocardial fiber orientation and local electrical conduction delay in the myocardial bridge region, its local ECG will exhibit characteristic fragmented potentials or delayed potentials. By identifying and analyzing these electrical signal characteristics, the localization and mapping module can assist the surgeon in determining the precise location and course of the myocardial bridge, thereby guiding the placement of the electrode body 1 and ensuring that the ablation area completely covers the entire length of the myocardial bridge. Since the mapping function and the ablation function share the same set of electrode pads 2, no additional mapping catheter is required, simplifying surgical instruments and procedures.

[0054] In this embodiment, regarding the pressure sensors, as mentioned earlier, they are used to ensure the adhesion quality between the electrode and the myocardium. The control logic employs a multi-channel AND logic for comprehensive judgment. That is, only when the readings of all pressure sensors are within a preset range (e.g., 5–20 g) does the system determine that the overall adhesion is good and unlock the discharge enable, allowing the pulse generator to output pulses. If the reading of any pressure sensor is below 5 g, the system indicates insufficient adhesion in that area; if the reading of any pressure sensor exceeds 20 g (preferably, if it exceeds 30 g, an emergency stop is triggered), the system indicates excessive pressure. This multi-condition combination judgment mechanism effectively eliminates the safety hazard of initiating ablation based solely on good adhesion at a single point, achieving hardware-level ablation safety interlock.

[0055] It should be noted that the pressure sensor multi-channel AND logic judgment in this invention is essentially a response of the system to whether to unlock and discharge based on the signals of each sensor as input conditions. It is a direct application and logical judgment of the sensor-acquired signals.

[0056] Furthermore, the ECG synchronization module, impedance monitoring module, positioning and mapping module, and pulse generator described in this invention all realize their functions through specific hardware units (ECG acquisition unit, trigger control unit) and electrical connections between modules; parameters such as R-wave delay of 200-400 milliseconds and impedance feedback adjustment are limitations on hardware working timing and thresholds, which are further definitions of product structure and connection relationships, rather than improvements to software processes or data processing methods.

[0057] In this embodiment, to monitor the thermal effects during the ablation process, the system also includes a temperature sensor electrically connected to the pulse generator. The temperature sensor is integrated within the electrode body 1, for example, it can be embedded between the electrode plates 2 or inside the substrate of the electrode body 1, for real-time monitoring of the temperature at the electrode-tissue interface. This temperature sensor is preferably a thermocouple or a thermistor, which has a fast response speed and high measurement accuracy, and can reflect temperature changes in the ablation area in real time. The pulse generator is configured to adjust the pulse output parameters based on the temperature signal fed back by the temperature sensor. When the interface temperature is detected to be close to or exceed a preset threshold (e.g., 50°C), the pulse generator can automatically reduce the output voltage, shorten the pulse width, or pause the pulse output, thereby ensuring that the ablation process is dominated by non-thermal mechanisms (irreversible electroporation), avoiding tissue carbonization, eschar formation, or thermal damage to surrounding normal tissue caused by Joule heating.

[0058] Example 5: This embodiment provides a minimally invasive myocardial bridging device, including a device body, on which the epicardial pulsed electric field ablation electrode system described in any one of embodiments 1-4 is installed.

[0059] In this embodiment, the device body serves as the platform for the ablation electrode system, integrating or externally connecting core functional units such as a pulse generator, an ECG synchronization module, and an impedance monitoring module. The device body also features an interface compatible with the handheld operating unit of the electrode body 1 for electrical connection and signal transmission. In practical applications, the device body can be designed as a mobile host, with a display screen and operating panel on its front panel to display real-time monitoring data such as ECG, impedance, pressure, and temperature, and to provide an entry point for parameter setting and ablation control. The operator can fully control the epicardial pulsed electric field ablation electrode system by operating the device body, including activating ECG synchronization, setting pulse parameters, starting / stopping ablation, and viewing impedance feedback.

[0060] In this embodiment, the pulse generator inside the device body generates a high-voltage pulse electric field, and its output is electrically connected to the electrode pads 2 on the electrode body 1 via cables. The electrocardiogram acquisition unit of the ECG synchronization module can be connected to the patient via surface leads or epicardial electrode lines. The trigger control unit is integrated into the device body and is used to receive ECG signals and generate trigger signals. The impedance monitoring module is also integrated into the device body and is independently connected to each electrode pad 2 via cables to realize real-time acquisition and processing of multi-channel impedance. The signal lines of the temperature sensor and pressure sensor also converge to the device body, where they are amplified, filtered, and converted from analog to digital by the signal processing circuit inside the device body, and finally presented on the display screen in a numerical or graphical manner.

[0061] By integrating the aforementioned ablation electrode system into a single device, the minimally invasive myocardial bridging device forms a highly integrated surgical system that is easy to use clinically. The surgeon only needs to place the electrode body 1 at the target location on the epicardium through a small intercostal incision and connect the relevant cables to the device body. Under the guidance and control of the device body, the surgeon can complete all the operation steps, including fat removal, fit verification, ECG-synchronized ablation, and impedance monitoring and protection, according to a standardized surgical procedure.

[0062] It should be noted that the device body, as a conventional carrier platform for each functional module, is a conventional technical means in this field. The improvement of this invention lies in the connection relationship and signal transmission relationship between each module and the electrode body.

[0063] Example 6: This embodiment provides a minimally invasive method for myocardial bridging, implemented using the epicardial pulsed electric field ablation electrode system described in any of embodiments 1-4 above, and includes the following steps: S1, the ECG R wave is detected by the ECG synchronization module. After the ECG R wave is detected, a preset time is delayed, and the pulse generator is triggered to output a pulse electric field during the diastolic phase of the heart. The pulse electric field is applied to the target myocardial tissue through the directional segmented ablation electrode set on the electrode body 1. S2, the impedance monitoring module collects the tissue impedance of the corresponding area of ​​each electrode 2 in real time. When the tissue impedance of a certain area decreases by more than the preset threshold compared with the baseline value before ablation, and the tissue impedance change rate reaches the plateau period, it is determined that the current area has been ablated and the pulse output of the electrode 2 in that area is stopped. S3, the contact force between the electrode body and the myocardial surface is monitored in real time by a pressure sensor integrated on the contact surface of the electrode body 1. When the force values ​​of all pressure sensors are within the preset ideal contact range, the discharge enable is unlocked, allowing the pulse generator to output a pulse electric field. When the force value of any pressure sensor exceeds the preset ideal contact range, a prompt signal is output. When the force value of any pressure sensor exceeds the safety threshold, the pulse generator is triggered to stop pulse output in an emergency. S4, the temperature of the electrode-tissue interface is monitored in real time by a temperature sensor integrated in the electrode body 1. When the interface temperature exceeds the preset temperature threshold, the pulse generator reduces the pulse output power or stops the pulse output.

[0064] Example 7: The structure and working principle of Embodiments 1-5 of the present invention will be further explained below: The present invention also aims to provide a method of using an epicardial pulsed electric field ablation electrode system, the method comprising the following steps: S1: Preoperative Image Planning. Preoperatively, coronary CTA (CCTA) 3D reconstruction is used to accurately measure the location (distance from the coronary ostium), depth (thickness of the myocardial bridge), length, and epicardial fat pad thickness of the myocardial bridge. Based on the depth and length of the myocardial bridge, an appropriate electrode body 1 (length and radius of curvature) is selected, and ablation parameters (voltage, number of pulse trains) are preset according to the depth of the myocardial bridge. Simultaneously, the location of the small intercostal incision is planned, typically the 4th or 5th intercostal space on the left side.

[0065] S2: Minimally invasive approach and pericardial exposure. After general anesthesia, a small incision (3-5 cm in length) is made through the 4th or 5th intercostal space on the left side. The chest wall tissues are dissected layer by layer to access the chest, the pericardium is opened and suspended, and the anterior wall of the heart is exposed. Under direct vision, the course of the left anterior descending artery and the area where the myocardial bridging is located are identified, and the proximal and distal boundaries of the myocardial bridging are confirmed. This small incision approach does not require sawing the sternum, does not compromise the stability of the chest wall, and results in less postoperative pain and faster recovery.

[0066] S3: Fat removal and clearance; the fat-removing wing clears the epicardial fat pad. See also... Figure 3Under direct vision, unfold the fat-scanning wings 4 on both sides of the electrode body 1 to a sweeping configuration. Push the fat-scanning wings 4 horizontally along the myocardial surface from proximal to distal, physically separating the fat pad covering the epicardial surface to expose the myocardial bridging surface. Drainage holes on the surface of the fat-scanning wings 4 reduce tissue fluid resistance, and the blunt, rounded edges prevent scratching the epicardium and myocardial surface. After fat sweeping, the effective fat thickness decreases from 1–8 mm to less than 1 mm, increasing the effective electric field strength reaching the myocardial target area by 40%–60%. The fat sweeping range should cover the entire length of the myocardial bridging and extend 3–5 mm to each side.

[0067] S4: Electrode Positioning and Adaptive Fit. The operator holds the control unit and places electrode body 1 (in a soft external form) directly onto the myocardium surface exposed by liposuction. Under body temperature (37°C), the nickel-titanium shape memory alloy of electrode body 1 undergoes a martensitic-austenitic phase transformation, restoring its preset arc-shaped strip-like unfolding shape, adaptively fitting the anatomical morphology of the myocardial bridge along the coronary artery. Optionally, an epicardial electrocardiogram is acquired through electrode pad 2 using a positioning mapping module. The location of the myocardial bridge is confirmed by fragmentation potentials or delayed potential characteristics, and the electrode is adjusted to ensure precise coverage of the entire myocardial bridge by the ablation area.

[0068] S5: Fitting quality verification, monitored by multiple pressure sensors. See also Figure 5 Multiple pressure sensors integrated into the contact surface of the electrode body 1 monitor the contact force between the electrode and the myocardial surface in real time. The electrode position and applied force are adjusted to maintain the force values ​​at all measuring points within a preset ideal contact range. When all sensor force values ​​are within the 5–20g range, good overall contact is determined, and the system unlocks and discharges. If any sensor reading is <5g, it indicates insufficient contact in that area; if any sensor reading is ≥20g (or triggers an emergency stop if ≥30g), it indicates excessive pressure.

[0069] S6: Synchronized Diastolic Ablation. The synchronized ECG module is activated to acquire the patient's ECG and detect the R wave in real time. A pulse generator is triggered 200–400 ms after the R wave (adjusted according to individual heart rate), outputting a biphasic pulse electric field during diastole to perform irreversible electroporation ablation of the myocardium above deep myocardial bridging. One pulse burst is released per cardiac cycle (each R wave). Pulse parameters are: voltage 800–2000V (preferably 1200–1800V), pulse width 1–20 microseconds (preferably 5–10 microseconds), pulse interval 50–500 microseconds (preferably 200 microseconds), and 10–100 pulses per burst (preferably 50). The pulse is released only during diastole to ensure that: the myocardial bridge thins during diastole, the ablation depth is controllable and stable; coronary perfusion is optimal during diastole, and the ablation has minimal impact on myocardial ischemia; and high-pressure pulses are avoided during the vulnerable period of the heart (T wave) to reduce the risk of arrhythmia.

[0070] S7: Impedance monitoring and intelligent coronary artery protection. See also Figure 6 During ablation, the impedance monitoring module collects the tissue impedance of the corresponding area of ​​each electrode 2 in real time. When the impedance of a certain area decreases by more than 30% compared with the baseline value before ablation, and the impedance change rate of three consecutive pulses is less than 5% (impedance plateau phase), it is determined that irreversible electroporation ablation has been completed in that area of ​​myocardium. The system automatically issues a prompt indicating that ablation in that area is complete and stops the pulse output of electrode 2 in that area. Independent impedance monitoring of each electrode 2 achieves zonal protection. The thickness of different areas of myocardial bridging may vary, and the ablation completion time may be inconsistent. Zonal monitoring ensures that ablation in each area is stopped independently at the appropriate time.

[0071] S8: Segmented / partitioned sequential ablation strategy. See also Figure 7 Based on the changes in the length and depth of the myocardial bridge, a segmented sequential ablation strategy can be adopted: first, the middle electrode is energized to ablate the middle segment of the myocardial bridge (usually the thickest), and after the impedance plateau indicates that the ablation is complete, the two end electrodes are energized to ablate the two ends of the myocardial bridge. Each region is independently impedance monitored and terminated independently. The ablation depth is controlled by the following parameters: (1) Myocardial bridge depth 2-3mm: voltage 1000-1200V, 5 pulses; (2) Myocardial bridge depth 3-5mm: voltage 1200-1500V, 8 pulses; (3) Myocardial bridge depth 5-7mm: voltage 1500-1800V, 10 pulses. The ablation depth should cover the entire myocardial bridge.

[0072] S9: Immediate assessment of ablation effect. After ablation, immediate effect assessment is performed in the following ways: (1) Use electrode pad 2 to re-examine the epicardial electrocardiogram and assess changes in electrical signals in the ablation area (disappearance or atypical fragmentation potentials); (2) Observe the impedance decrease in each area (target ΔZ>30%) to confirm the adequacy of ablation; (3) If necessary, assess coronary artery patency and vessel wall integrity by intraoperative coronary angiography or intravascular ultrasound; (4) Observe for abnormalities such as edema and ecchymosis in the epicardium of the coronary arteries. If areas that do not meet the ablation target are found, supplement with 1 to 3 pulse ablations.

[0073] S10: Withdrawal and Chest Closure. After ablation reaches the target, retract the fat-sweeping wings 4 to a folded shape. The electrode body 1 can be cooled to below the phase transition temperature by perfusion with cold saline (0-5℃), restoring it to a soft shape for safe withdrawal through a small intercostal incision. Check the epicardial surface for bleeding or damage, suture the pericardium (a drainage tube may be left in place), and close the chest layer by layer.

[0074] The above method will be further explained through specific application examples below.

[0075] Application Example 1: Deep myocardial bridging in the mid-segment of the left anterior descending artery Patient profile: Male, 52 years old. Coronary CTA showed myocardial bridging in the mid-segment of the left anterior descending artery, with a bridging depth of 5.2 mm, a length of 18 mm, an epicardial fat pad thickness of 2.8 mm, and a target segment coronary artery diameter of 3.2 mm. Preoperative coronary angiography showed systolic coronary artery lumen compression >70%.

[0076] S1, Preoperative planning: After CCTA 3D reconstruction measurement, the preset voltage is 1600V, with 50 pulses per series, and a target of 10 series (automatic termination determined by impedance monitoring). The selected electrode body 1 has a length of 40mm, a radius of curvature R=20mm, and 5 electrode pads 2. The incision location is the 4th intercostal space on the left side.

[0077] S2, minimally invasive approach: After general anesthesia, a 4cm incision is made through the left 4th intercostal space, the pericardium is opened and suspended and fixed, and the anterior wall of the heart is exposed. Under direct vision, the myocardial bridging in the middle segment of the LAD is confirmed, and the proximal and distal boundaries are marked with sutures.

[0078] S3, Fat Sweeping: See also Figure 4 The fat-sweeping wings were extended to a sweeping shape (16 mm wide) and pushed horizontally along the myocardial surface from proximal to distal, pushing the fat pads to both sides by about 5 mm. After fat sweeping, the epicardial surface was smoothly exposed, and the pale red myocardial tissue in the myocardial bridging area was visible to the naked eye.

[0079] S4, Electrode Placement: Using the handheld operating unit, place electrode body 1 onto the exposed myocardial bridging surface. Within 30 seconds, electrode body 1 returns to its preset arc-shaped strip form under body temperature, adhering tightly to the myocardial surface. Use the mapping function of electrode pad 2 to acquire an epicardial electrocardiogram to confirm that the electrode position covers the entire length of the myocardial bridging.

[0080] S5, Fit Verification: The 5 pressure sensors showed 14g, 16g, 19g, 15g and 13g respectively, all within the excellent fit range of 12-25g, and the system unlocked and discharged.

[0081] S6, ECG-synchronized ablation: Heart rate 68 bpm, trigger control unit triggers pulse generator 300ms after R wave delay. Pulse parameters: voltage 1600V, biphasic symmetrical square wave, pulse width 8μs, pulse interval 200μs, 50 pulses per series, interval between series approximately 0.88 seconds / series.

[0082] S7, Impedance Monitoring: Baseline impedances before ablation were 538Ω, 521Ω, 556Ω, 543Ω, and 528Ω. After the 5th pulse series, the impedance decrease rates of the three middle channels were 32%, 35%, and 31%, respectively, with three consecutive series of change rates <5%, automatically stopping after the 7th pulse. The impedances of the two ends entered a plateau period after the 8th pulse (ΔZ=31% and 33%), automatically stopping after the 8th pulse. A total of 8 pulse series were used for ablation.

[0083] S8, Outcome Assessment: Follow-up epicardial electrocardiogram showed the disappearance of the original fragmented potentials. Impedance decreased by a mean of 33% compared to baseline. Intraoperative coronary angiography showed patent LAD with no abnormalities in the vessel wall. FFR increased from 0.72 preoperatively to 0.91.

[0084] S9, Withdrawal: The fat-sweeping wings 4 were retracted, and the electrode body 1 was cooled with 4°C cold saline. The electrode body 1 returned to its soft shape and was successfully withdrawn through an intercostal incision. The epicardial ablation area was examined; mild edema was observed on the myocardial surface, with no bleeding or perforation, and the coronary adventitia remained intact. The pericardium was sutured, a drainage tube was placed, and the chest was closed layer by layer.

[0085] S10, Summary: The total operation time was 72 minutes, with intraoperative blood loss of approximately 30 ml. The patient was extubated 2 hours postoperatively, the pericardial drainage tube was removed on postoperative day 1, and the patient was able to get out of bed. The patient was discharged on postoperative day 4. A 1-month follow-up CTA showed that the myocardial bridging thickness decreased from 5.2 mm preoperatively to approximately 0.8 mm, and systolic coronary artery compression decreased from >70% to <20%.

[0086] Application Example 2: Patient profile: Female, 58 years old, with a very deep myocardial bridging in the proximal-mid segment of the LAD, bridging depth 6.8 mm, length 22 mm, and epicardial fat pad thickness 4.5 mm.

[0087] Preoperative planning: The bridge depth of 6.8mm is considered extremely deep (>5mm). The preset starting voltage is 1800V, and the pulse parameters are a pulse width of 10μs, 60 pulses per series, and a target of 12 series. A 5-electrode pad with a 2-size designation and an electrode spacing of 4mm are selected.

[0088] S1, voltage adaptive: Based on the depth-voltage model (Vout = 1200×(1+0.35×6.8 / 2)≈2629V, take the safe upper limit of 2500V), the actual operating voltage is 1800V (to keep the coronary endothelial electric field <400 V / cm).

[0089] S2, Enhanced fat removal: The fat pad was relatively thick at 4.5mm. After the fat removal wings 4 were deployed, the fat was repeatedly pushed along the myocardial surface 3 times, effectively pushing the fat away to a width of about 6mm. After fat removal, the impedance decreased from >300Ω before fat removal to 85-120Ω (normal myocardial range), confirming that the attenuation of the electric field by the fat layer was effectively eliminated.

[0090] S3, segmented sequential ablation: Bridge length 22mm, using a segmented strategy, first apply power to E2-E3-E4 to ablate the thickest middle section (6.8mm depth), the impedance plateau occurs after the 8th string; then apply power to E1 and E5 to ablate both ends (depth gradually decreasing to approximately 4mm), reaching plateaus after the 5th and 6th strings respectively. A total of 11 strings are ablated.

[0091] S4, Intraoperative monitoring: Temperature sensor monitors interface temperature throughout the procedure, with a maximum of 38.7℃ (confirmed by non-thermal ablation), and over-temperature protection is effective.

[0092] S5, Outcome: Postoperative CTA showed significant thinning of the myocardial bridging, and systolic coronary artery compression decreased from 85% preoperatively to approximately 30%. No complications.

[0093] The following comparison illustrates the differences in technical effects between using the system of this invention and existing technologies such as traditional surgical myotomy: Table 1. Differences in technical outcomes between traditional surgical myocardial bridging and conventional surgical myocardial bridging.

[0094] Table 2. Differences in technical effects compared to existing technologies

[0095] Compared with existing technologies, this invention has the following significant advantages: By using a small intercostal incision approach instead of median thoracotomy, and combining irreversible electroporation ablation with pulsed electric fields to replace traditional scalpel resection, minimally invasive non-resectable myocardial bridging is achieved. This avoids the serious risks of coronary artery injury, cardiac rupture, and ventricular aneurysm formation associated with traditional bridging procedures, while retaining the advantage of precise localization of the myocardial bridging under direct vision. Postoperative recovery is rapid, and hospitalization time is short. The electrode body 1 is made of nickel-titanium shape memory alloy, which is soft at room temperature for easy hand-held manipulation through a small incision. After placement on the epicardium, it adaptively recovers to an unfolded shape adapted to the course of the myocardial bridging along the coronary arteries under body temperature, achieving close contact between the electrode and the myocardial surface and avoiding... The complex mechanical mechanism is easy to operate and provides a better fit than existing annular or spherical catheters. The fat-scanning wings 4, located on both sides of the electrode body 1, unfold before electrode placement and push along the myocardial surface, physically separating the epicardial fat pad. This reduces the effective fat thickness to below 1 mm, increasing the effective electric field strength reaching the myocardial target area by 40%-60%, solving the core problem of electric field attenuation and contact barriers caused by the epicardial fat layer. The insulating shielding layer 3, located on the side of the electrode body 1 facing away from the myocardium, allows the pulsed electric field to radiate unidirectionally towards the myocardium. Combined with the ECG synchronization module detecting the R wave on the ECG and triggering the pulse generator to output the pulsed electric field during diastole, this avoids excessive ablation and coronary artery damage caused by thickening of the myocardial bridge during systole, while also avoiding the vulnerability of the T wave on the ECG. During this period, the risk of arrhythmia is reduced. The pressure sensor integrated into the contact surface of the electrode body 1 achieves closed-loop verification of the entire ablation surface through multi-channel independent sampling and logical comprehensive judgment, maintaining the contact force within the ideal range of 5-20 grams, ensuring effective ablation while avoiding excessive compression of the myocardium, and eliminating single-point adhesion artifacts. The impedance monitoring module is electrically connected to each electrode pad 2, and monitors the tissue impedance of the corresponding area of ​​each electrode pad 2 in real time. When the impedance drop in a certain area exceeds the preset threshold and the change rate of multiple consecutive pulses is less than 5%, it enters the impedance plateau period, and it is determined that the myocardium in that area has been completely ablated and the pulse output of the electrode pad 2 in that area is automatically stopped, avoiding the electric field from continuing to act on the coronary artery wall and causing damage. The independent monitoring of each electrode pad 2 achieves the goal of separate ablation. The electrode body 1 features a temperature sensor integrated within it that monitors the electrode-tissue interface temperature in real time and feeds it back to the pulse generator. This keeps the interface temperature below 50°C, ensuring that ablation is a non-thermal mechanism. By utilizing the characteristic that the electric field threshold of myocardial cells is lower than that of vascular smooth muscle and nerves, it naturally protects the coronary artery below the myocardial bridge from damage. The electrode pad 2 also has an epicardial mapping function. Before ablation, an epicardial electrocardiogram can be collected to identify the location and course of the myocardial bridge to accurately delineate the ablation range. After ablation, the effect can be re-evaluated. Mapping and ablation share the same set of electrode pads 2 without the need for additional instruments. The perfusion channel extending along the length of the electrode body 1 cools the electrode body 1 to below the phase transition temperature and restores its soft shape by perfusing with cold physiological saline, making it easy to remove after the procedure.The comprehensive application of the above-mentioned techniques integrates minimally invasive approach establishment, fat removal and obstacle clearing, adaptive apposition, apposition verification, ECG-synchronized diastolic ablation, impedance monitoring and intelligent protection, and effect evaluation into a standardized surgical procedure. This reduces the learning curve for surgeons and enables thorough, safe, and effective release of deep myocardial bridges under minimally invasive conditions. It overcomes the technical problems of existing central epicardial approach, which makes it difficult to safely and effectively perform deep myocardial bridge ablation due to fat pad obstruction, uncontrollable ablation depth under beating heart, and lack of coronary artery protection monitoring mechanism.

[0096] The foregoing has shown and described the basic principles, main features, and advantages of the present invention. It will be apparent to those skilled in the art that the present invention is not limited to the details of the exemplary embodiments described above, and that the invention can be implemented in other specific forms without departing from its spirit or essential characteristics. Therefore, the above embodiments should be considered exemplary rather than restrictive in all respects; the scope of protection of the present invention is defined by the appended claims, not by the foregoing description, and thus all changes falling within the meaning and scope of the equivalents of the claims are intended to be included within the present invention. No reference numerals in the claims should be construed as limiting the scope of the claims.

[0097] Furthermore, it should be understood that although this specification describes embodiments, not every embodiment contains only one independent technical solution. This narrative style is merely for clarity; those skilled in the art should consider the specification as a whole. The technical solutions in each embodiment can also be appropriately combined to form other embodiments that can be understood by those skilled in the art. The above content is merely illustrative of the technical concept of the present invention and should not be construed as limiting the scope of protection of the present invention. Any modifications made to the technical solutions based on the technical concept proposed in this invention fall within the scope of protection of the claims of this invention.

Claims

1. An epicardial pulsed electric field ablation electrode system, characterized in that, include: The electrode body (1) includes a soft shape at room temperature outside the body, and an unfolded shape that is restored under body temperature after being placed on the epicardium and is adapted to the course of the myocardial bridge along the coronary artery. The directional segmented ablation electrode includes a plurality of electrode pieces (2) arranged in segments along the length of the electrode body (1) and an insulating shielding layer (3) disposed on the side of the electrode body (1) facing away from the myocardium. The electrode pieces (2) are disposed on the side of the electrode body (1) facing the myocardial surface, and the insulating shielding layer (3) is used to radiate the pulsed electric field unidirectionally toward the myocardium. The fat-sweeping wing (4) is deployable on the side of the electrode body (1) and is used to physically separate the epicardial fat pad before the electrode body (1) is placed, thereby exposing the myocardial surface; The ECG synchronization module is used to acquire the patient's ECG signal and generate a trigger signal during the diastolic phase of the heart based on the ECG signal. The impedance monitoring module is electrically connected to each electrode (2) and is used to monitor the impedance of the myocardial tissue region corresponding to each electrode (2) in real time. The pulse generator is electrically connected to the directional segmented ablation electrode section, the ECG synchronization module, and the impedance monitoring module. It is used to output a pulsed electric field during cardiac diastole based on the trigger signal of the ECG synchronization module, and to adjust the pulse output by impedance feedback or terminate the pulse output based on the monitoring results of the impedance monitoring module.

2. The epicardial pulsed electric field ablation electrode system according to claim 1, characterized in that, The electrode body (1) in both the soft and unfolded forms is strip-shaped; The length of the electrode body (1) is 30-50 mm and the width is 6-10 mm.

3. The epicardial pulsed electric field ablation electrode system according to claim 1, characterized in that, The electrode body (1) is made of nickel-titanium shape memory alloy, and the phase transition temperature of nickel-titanium shape memory alloy is 32℃~38℃.

4. The epicardial pulsed electric field ablation electrode system according to claim 1, characterized in that, The electrode body (1) is provided with an infusion channel extending along its length. The infusion port of the infusion channel is located at the end of the electrode body (1) close to the operator, and the outlet of the infusion channel is located at the end of the electrode body (1) away from the operator and / or on the side of the electrode body (1). This channel is used to infuse cold physiological saline into the electrode body (1) so that the electrode body (1) cools down to below the phase transition temperature and returns to a soft shape.

5. The epicardial pulsed electric field ablation electrode system according to claim 1, characterized in that, The number of electrode sheets (2) is 3 to 8, and an insulating silicone spacer is provided between adjacent electrode sheets (2); The fat-sweeping wings (4) are nickel-titanium alloy sheets symmetrically arranged on both sides of the electrode body (1), including a folded storage form at room temperature outside the body, and a sweeping form that is laid out to both sides under the action of body temperature after being placed on the epicardium. The width of the sweeping form is greater than the width of the electrode body (1). The edge of the fat-sweeping wing (4) is a blunt arc structure, and the surface of the fat-sweeping wing (4) is provided with drainage holes to guide tissue fluid through during the fat-sweeping wing (4) pushing process, thereby reducing pushing resistance.

6. The epicardial pulsed electric field ablation electrode system according to claim 1, characterized in that, The ECG synchronization module includes an ECG acquisition unit and a trigger control unit. The ECG acquisition unit is equipped with a three-lead electrode interface on the body surface or an epicardial electrode interface for acquiring the patient's ECG signal. The trigger control unit is electrically connected to the ECG acquisition unit and the pulse generator for detecting the ECG R wave and triggering the pulse generator to output a pulse after a delay of 200 to 400 milliseconds following the R wave.

7. The epicardial pulsed electric field ablation electrode system according to claim 1, characterized in that, It also includes a positioning and mapping module, which is electrically connected to each electrode (2) to collect epicardial electrograms and then identify the location and course of myocardial bridges.

8. The epicardial pulsed electric field ablation electrode system according to claim 1, characterized in that, It also includes a pressure sensor electrically connected to the pulse generator and a temperature sensor electrically connected to the pulse generator; The pressure sensor is integrated on the surface of the electrode body (1) that contacts the myocardium, and is used to monitor the contact force between the electrode and the myocardium in real time; The temperature sensor is integrated into the electrode body (1) and is used to monitor the temperature at the electrode-tissue interface.

9. The epicardial pulsed electric field ablation electrode system according to claim 8, characterized in that, The number of pressure sensors is matched with the number of electrode pads (2), and the pressure sensors and electrode pads (2) are alternately arranged on the side of the electrode body (1) facing the myocardial surface; The pressure sensor has a monitoring range of 0–50 g.

10. A minimally invasive myocardial bridging device, characterized in that, The device includes a main body on which the epicardial pulsed electric field ablation system according to any one of claims 1-9 is installed.

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