Ablation system

Abstract

An ablation system is disclosed. The ablation system comprises a tubular ablation catheter and an ablation instrument. The catheter comprises a far end used for being attached to target tissue to be ablated, a near end used for being connected with the ablation instrument and a catheter body located between the far end and the near end. The ablation instrument transmits radio frequency / pulse energy to the ablation catheter, so that the catheter ablates the target tissue; the electrode group at the far end is used for collecting electrocardiosignals of target tissues and transmitting the electrocardiosignals to the three-dimensional heart electrophysiological mapping system to realize heart modeling and mapping, and each electrode has the capabilities of collecting the electrocardiosignals and ablating the target tissues; and the electrode group receives a control signal from the ablation instrument, and determines that the electrodes in the electrode group work in a single-pole / double-pole mode according to the control signal and realizes dotted / linear ablation. According to the system, mapping and ablation functions are integrated in a single catheter, two purposes are achieved through one catheter, flexible switching of various ablation modes / shapes / energy is supported, and high universality is achieved.

Description

Technical Field

[0001] This application relates to the field of cardiac ablation technology, and more particularly to an ablation system. Background Technology

[0002] Cardiac ablation is a minimally invasive interventional procedure commonly used to treat atrial or ventricular arrhythmias, especially atrial fibrillation and supraventricular tachycardia. Its basic principle is to use an ablation catheter to release radiofrequency energy or other forms of energy to ablate abnormal conduction pathways or ectopic pacemakers within the heart, thereby blocking the conduction of abnormal electrical signals. Clinically, ablation methods mainly include point ablation and linear ablation. Point ablation is suitable for treating localized abnormal lesions, while linear ablation is often used to create conduction block lines to prevent recurrence of arrhythmias.

[0003] However, in actual surgical procedures, traditional point-based or linear ablation catheters mostly only have ablation functionality. Surgeons still need to use specialized mapping catheters to complete three-dimensional cardiac modeling and electrophysiological mapping before switching to the ablation catheter to perform the ablation operation on the target tissue. This catheter replacement process not only increases the number of steps and surgical time but also carries the risk of complications such as thrombosis and endocardial damage, posing certain safety hazards. Furthermore, existing ablation catheters mostly employ point-by-point ablation, which is less efficient in linear ablation and cannot meet the treatment needs of complex arrhythmias. Therefore, existing ablation systems still have shortcomings in terms of functional integration and clinical application efficiency, requiring further improvement. Summary of the Invention

[0004] In view of this, this application discloses an ablation system that organically combines an ablation catheter, an ablation device, and a three-dimensional cardiac electrophysiological mapping system to achieve the integration of mapping and ablation functions in a single ablation catheter. It supports flexible switching between radiofrequency / pulse dual energy, monopolar / bipolar modes, and point / linear ablation, significantly improving the versatility and efficiency of clinical applications.

[0005] The ablation system includes an ablation catheter and an ablation device. The ablation catheter includes a first end for abutting the target tissue, a second end for connecting to the ablation device, and a catheter body located between the first and second ends. The ablation catheter is tubular. The ablation device is configured to transmit radiofrequency energy to the ablation catheter to perform radiofrequency ablation on the target tissue, or the ablation device is configured to transmit pulsed energy to the ablation catheter to perform pulsed ablation on the target tissue. The first end includes an electrode group with at least 10 electrodes. The electrode group is configured to acquire electrocardiogram (ECG) signals in the space where the target tissue is located and transmit the ECG signals to a three-dimensional cardiac electrophysiological mapping system, enabling the three-dimensional cardiac electrophysiological mapping system to model and map the heart based on the ECG signals. Furthermore, the electrode group is also configured to receive control signals from the ablation device and ablate the target tissue using radiofrequency energy or pulsed energy according to the control signals. Each electrode in the electrode group has the ability to acquire ECG signals and ablate the target tissue. The control signals include a first sub-controller. The ablation system includes a first sub-control signal and a second sub-control signal. The first sub-control signal controls the electrodes in the electrode group to ablate the target tissue in either unipolar or bipolar mode. In unipolar mode, all electrodes selected for ablation in the electrode group output positive signals. In bipolar mode, the electrodes selected for ablation in the electrode group include at least one electrode that outputs a positive signal and at least one electrode that outputs a negative signal. The second sub-control signal controls the electrodes in the electrode group to perform point-like or linear ablation on the target tissue. The ablation system also includes a bending control handle disposed between the second end and the ablation device, and the first end is an adjustable bending section. The first end swings around a first point under the control of the bending control handle to determine a mapping area. The first point is the connection point between the first end and the catheter body. The range of a mapping area is determined by the first point, the length of the first end, and the degree of bending of the first end. The first end also includes a pressure sensor and comprises a flexible section and a rigid section. The pressure sensor and at least two electrodes are disposed in the rigid section, and the remaining electrodes in the electrode group are disposed in the flexible section.

[0006] Optionally, the ablation system also includes an adapter box, which is connected to the ablation device, the three-dimensional cardiac electrophysiological mapping system, the ablation catheter, and the back electrode patch, respectively. The adapter box is used to select the radiofrequency ablation pathway or the pulse ablation pathway between the ablation device and the ablation catheter, transmit the data acquired by the ablation catheter during the operation to the three-dimensional cardiac electrophysiological mapping system, and construct the loop between the ablation catheter and the back electrode patch in unipolar mode.

[0007] Optionally, the control signal may also include a third sub-control signal, which is used to determine the number and location of electrodes used for ablation in the electrode group.

[0008] Optionally, when the first sub-control signal controls the electrodes in the electrode group to ablate in unipolar mode, the ablation device sets the second sub-control signal to perform point ablation on the target tissue.

[0009] Optionally, when the first sub-control signal controls the electrodes in the electrode group to ablate in bipolar mode, the ablation device sets the second sub-control signal to perform linear ablation on the target tissue.

[0010] Optionally, the number of electrode groups is between 10 and 20, and the electrode group includes a head electrode and several ring electrodes. The head electrode is disposed at the distal end of the first end, and the several ring electrodes are arranged along the direction from the distal end to the proximal end of the first end. The pressure sensor is used to transmit the pressure data between the first end and the target tissue to the three-dimensional cardiac electrophysiological mapping system in real time, so that the three-dimensional cardiac electrophysiological mapping system can determine the contact status of the first end. The width of the head electrode is between 1.5 mm and 5 mm, the width of each ring electrode is between 0.3 mm and 3 mm, and the diameter of each electrode in the electrode group is between 2 mm and 4 mm. Except for the spacing between two electrodes adjacent to the pressure sensor, the spacing between two adjacent electrodes is between 1 mm and 5 mm, and the spacing between two electrodes adjacent to the pressure sensor is determined by the size of the pressure sensor.

[0011] Optionally, at least one ring electrode is provided between the pressure sensor and the head electrode.

[0012] Optionally, each electrode in the electrode group has an impedance detection function and is used to transmit the detected impedance data to the ablation device, so that the three-dimensional cardiac electrophysiological mapping system determines whether each electrode is in effective contact with the target tissue according to the preset pressure range and the ablation device according to the preset impedance range; the three-dimensional cardiac electrophysiological mapping system is also used to determine whether the target tissue is abnormal myocardial tissue according to the data obtained from the first end mapping. During ablation, the ablation device defaults to selecting the electrode that is in effective contact and is in contact with the marked abnormal myocardial tissue for ablation.

[0013] Optionally, the head electrode has a protrusion at the end near the pressure sensor, and an insulating sleeve is provided between the protrusion and the pressure sensor to achieve electrical insulation between the pressure sensor and the protrusion.

[0014] Optionally, the rigid section also includes a protective sleeve, which is provided at least around the pressure sensor so that the pressure sensor is located inside the protective sleeve, and the ring electrodes on the rigid section are all provided outside the protective sleeve.

[0015] In summary, the ablation system disclosed in this application has at least the following beneficial effects: (1) The catheter described in this application has undergone overall optimization in terms of the number of electrodes, distal structure, and pressure sensor configuration, enabling it to not only efficiently acquire intracardiac electrical signals and transmit them to a three-dimensional mapping system for modeling and mapping, but also to perform ablation operations on the same catheter. Unlike the prior art where "ablation catheters can be mapped but are inefficient," this application achieves mapping efficiency close to that of dedicated mapping catheters through the synergistic effect of the above-mentioned technical features, thus truly achieving "one catheter for two uses." In this way, the cumbersome process of repeatedly changing catheters during the mapping and ablation stages in traditional techniques is avoided, significantly shortening the operation time and reducing the risk of infection and operation caused by changing catheters. It also enables doctors to complete mapping and ablation simultaneously with one catheter in clinical practice, greatly improving the convenience of operation and the overall treatment effect.

[0016] (2) The ablation device in this application can output both radiofrequency energy and pulsed energy, and the ablation catheter can use this energy to ablate the target tissue. Thus, the ablation system can simultaneously meet the clinical needs of radiofrequency ablation and pulsed thermal ablation to adapt to different lesions and different patient conditions.

[0017] (3) The ablation system in this application can switch between unipolar and bipolar modes via a first sub-control signal, and can select between point ablation and linear ablation via a second sub-control signal; furthermore, the ablation device can also select the corresponding optimal ablation shape by default according to the determined ablation method (unipolar or bipolar). In this way, doctors can flexibly adjust the ablation strategy according to the type of arrhythmia, and improve the continuity and thoroughness of the ablation range.

[0018] (4) The electrode assembly in this application also has an impedance detection function, and a pressure sensor can be installed at the distal end of the ablation catheter to transmit data to the ablation instrument and the mapping system respectively to determine the contact status. In this way, ineffective ablation caused by insufficient contact during energy output or cardiac perforation caused by excessive contact can be solved, thereby improving the safety of operation and the therapeutic effect.

[0019] (5) The adapter box disclosed in this application enables unified signal and energy management among the various components of the system. Through the adapter box, on the one hand, the radiofrequency ablation pathway or pulse ablation pathway between the ablation device and the ablation catheter can be flexibly selected, allowing the same catheter to switch between different ablation energy types as needed, thereby improving the diversity and adaptability of ablation methods; on the other hand, the adapter box can transmit signals to the three-dimensional cardiac electrophysiological mapping system in real time during ablation catheter acquisition for modeling and mapping, thus maintaining the dual function of the catheter during surgery. Furthermore, the adapter box can automatically establish a circuit between the ablation catheter and the back electrode patch in unipolar mode, avoiding complex external connection operations by the physician during surgery. In summary, the introduction of the adapter box not only simplifies the connection between the catheter, ablation device, and three-dimensional system, improving the overall operational convenience and stability of the system, but also further enhances the application capability of the catheter in various clinical scenarios.

[0020] (6) A protrusion is provided at the end of the head electrode near the pressure sensor, and an insulating sleeve is added between the protrusion and the pressure sensor to achieve electrical insulation between the pressure sensor and the protrusion. This effectively avoids excessive current causing breakdown or damage to the pressure sensor during electrode operation, ensuring its long-term stable operation. At the same time, a protective sleeve is also provided in the rigid section. This protective sleeve is arranged at least around the pressure sensor, so that the pressure sensor is located inside the protective sleeve. This prevents the pressure sensor from directly contacting the myocardial tissue, avoiding signal interference and mechanical wear. On the other hand, it provides additional rigid support for the pressure sensor and its surrounding area, allowing the distal end of the catheter to better achieve the positioning and support functions of the rigid section. Through the dual protection design of the insulating sleeve and the protective sleeve, the pressure sensor not only has electrical safety and stability, but also mechanical protection and structural reliability, thus significantly improving the overall durability and clinical applicability of the catheter. Attached Figure Description

[0021] The accompanying drawings used in the description of the embodiments of this application are briefly introduced below.

[0022] Figure 1 The diagram shows an example structure of an ablation catheter provided in an embodiment of this application.

[0023] Figure 2 This application illustrates a method of using an ablation system provided in an embodiment.

[0024] Figure 3 This paper shows a structural example of another ablation catheter provided in an embodiment of this application.

[0025] Figure 4 The diagram shows the effect of unipolar point ablation of an ablation catheter disclosed in an embodiment of this application.

[0026] Figure 5 The diagram shows the bipolar point ablation effect of an ablation catheter disclosed in an embodiment of this application.

[0027] Figure 6 The diagram shows the effect of unipolar linear ablation of an ablation catheter disclosed in this application under all electrode discharge conditions.

[0028] Figure 7 The diagram shows the bipolar linear ablation effect of an ablation catheter disclosed in this application under all electrode discharge conditions.

[0029] Figure 8 The diagram shows the effect of unipolar linear ablation of an ablation catheter disclosed in this application under partial electrode discharge.

[0030] Figure 9 The diagram shows the bipolar linear ablation effect of an ablation catheter disclosed in this application under partial electrode discharge conditions.

[0031] Figure 10 The diagram shows the ablation effect of an ablation catheter disclosed in an embodiment of this application on a potato.

[0032] Figure 11 The diagram shows the ablation effect of another ablation catheter disclosed in this application on a potato.

[0033] Figure 12 The diagram shows the ablation effect of another ablation catheter disclosed in this application on a potato.

[0034] Figure 13 The diagram shows the ablation effect of an ablation catheter disclosed in an embodiment of this application on the isolated heart of a deceased animal.

[0035] Figure 14 The diagram shows the ablation effect of another ablation catheter disclosed in this application on the isolated heart of a dead animal.

[0036] Figure 15 A physical diagram of an ablation catheter provided in an embodiment of this application is shown.

[0037] Figure 16 This diagram illustrates a structural example of the head electrode of an ablation catheter provided in an embodiment of this application (without an insulating sleeve).

[0038] Figure 17 This paper shows a structural example diagram of the head electrode of another ablation catheter provided in an embodiment of this application (with an insulating sleeve).

[0039] Figure 18An enlarged view of the first end of an ablation catheter provided in an embodiment of this application is shown. Detailed Implementation

[0040] To more clearly illustrate the technical solutions of the embodiments of this application, the specific implementation methods of this application will be described below with reference to the accompanying drawings. The accompanying drawings described below are only some embodiments of this application. For those skilled in the art, other drawings and other implementation methods can be obtained based on these drawings without creative effort. Adjustments and improvements made without departing from the concept of this application are all within the protection scope of this application.

[0041] To keep the drawings simple, only the parts related to the corresponding embodiments are shown schematically in each figure, and they do not represent the actual structure of the product. In addition, to make the drawings simple and easy to understand, some parts with the same structure or function are only shown schematically in some figures, and there may actually be more or fewer parts with the same structure or function.

[0042] In this application, unless otherwise expressly specified and limited, ordinal numbers, such as "first," "second," etc., are used only to distinguish and describe related objects, and should not be construed as indicating or implying the relative importance or order between related objects; furthermore, they do not represent the quantity of related objects. "Multiple" includes two or more, and other quantifiers are similar. " / " is used to describe the relationship between related objects, indicating an "or" relationship between them. "And / or" is used to describe the relationship between related objects, including any combination relationship between them, such as "a and / or b" including: "a alone," "b alone," or "a and b." "One or more" or "at least one" of multiple objects refers to any object or any combination of multiple objects, such as "one or more of a1, a2, a3" or "at least one of a1, a2, a3" including: "a1 alone," "a2 alone," "a3 alone," "a1 and a2," "a1 and a3," "a2 and a3," or "a1, a2 and a3."

[0043] Cardiac arrhythmias are a common type of abnormal cardiac electrical activity. Essentially, they arise from abnormal origins of electrical activity in the myocardial tissue or abnormal electrical signal conduction pathways within the heart, leading to irregular heart rhythms and potentially causing palpitations, decreased cardiac function, or even sudden death. Currently, radiofrequency ablation (RFA) is one of the important clinical treatments for cardiac arrhythmias. The basic principle of RFA is as follows: using a controllable ablation catheter, the distal electrode is inserted into the heart chamber, adhering closely to the surface of the target myocardial tissue. Radiofrequency energy is then released, causing coagulative necrosis of the tissue, thereby blocking abnormal electrical conduction pathways or ablating ectopic pacemakers. In this way, doctors can reconstruct normal cardiac conduction pathways, achieving the therapeutic effect.

[0044] In traditional radiofrequency ablation procedures, the most common catheter types are point ablation catheters and linear ablation catheters. Point ablation catheters are characterized by a small electrode at the distal end. The physician manipulates the catheter to place this electrode close to the myocardial surface, releasing energy each time to create a small, localized "point lesion." However, many lesions in clinical practice are not single point areas but require the formation of a complete isolation line (e.g., constructing a circular ablation line around the pulmonary vein opening to isolate the triggering source of atrial fibrillation). In such cases, the physician needs to repeatedly move the catheter electrode: first releasing energy at a point to create a point lesion, then moving the catheter to an adjacent location, releasing energy again to create another point, and so on, accumulating point by point until multiple points are connected end-to-end to form a continuous linear ablation zone. This method is characterized by "drawing a line point by point," resulting in low efficiency and high dependence on the physician's skill.

[0045] The design concept of linear ablation catheters is to arrange multiple electrodes at the distal end of the catheter in a straight line or arc to create a linear lesion in a single procedure. However, in traditional clinical applications, these catheters typically still employ a sequential energy release method, releasing energy electrode by electrode. That is, although the catheter itself has multiple electrodes, the physician often releases energy from the first electrode, then the second, then the third, completing the process one by one, and finally connecting these point-like lesions into a line. In other words, even with a "linear ablation catheter," the actual effect is still similar to that of a point-like catheter, only the number of electrodes has increased, but the entire ablation line cannot be constructed in one go. Therefore, whether using a point-like or linear catheter, traditional radiofrequency ablation still requires the physician to complete an ablation line through "multiple, point-by-point energy releases," like "dot drawing."

[0046] This traditional "point-by-point drawing" method has significant shortcomings. First, it's inefficient: the surgeon needs to repeatedly manipulate the catheter, performing placement, energy release, and movement at each point, followed by re-placement and release, making the entire process time-consuming. Second, it lacks continuity: because the procedure relies entirely on manual control, deviations in catheter placement or excessively large gaps between points can create "gaps" in the ablation line, forming so-called "conduction gaps." These gaps can allow electrical signals to escape, leading to recurrence of arrhythmias after ablation. Third, it's technically challenging: the surgeon must repeatedly and meticulously manipulate the catheter within a limited time, ensuring sufficient coverage of ablation points while avoiding over-ablation that could damage the myocardium, demanding a high level of experience and skill from the surgeon.

[0047] Furthermore, in existing technologies, a typical cardiac radiofrequency ablation procedure usually requires the sequential use of two types of catheters with different functions. At the start of the procedure, the surgeon inserts a dedicated mapping catheter into the heart chamber. This catheter typically carries a large number of electrodes, up to dozens, to acquire electrophysiological signals at different locations within the heart chamber in real time and transmit the data to a three-dimensional electrophysiological mapping system. Through multi-point sampling via the mapping catheter, the surgeon can quickly and accurately create a three-dimensional electroanatomical map of the heart chamber and the distribution of abnormal electrical activity. After the mapping is completed and a complete electrophysiological map is obtained, the surgeon removes the mapping catheter and replaces it with a dedicated ablation catheter. While the ablation catheter has some signal acquisition capabilities, its primary function is to release radiofrequency energy to the target tissue to complete the ablation operation. Therefore, the number and spatial distribution of electrodes are far fewer than with the mapping catheter, approximately 4-8 electrodes. During this stage, the ablation catheter connects to the ablation device to perform ablation while simultaneously maintaining data interaction with the three-dimensional mapping system for localization and effect verification during the procedure. Therefore, in the existing technology, the entire surgical procedure requires two different catheters: first, a mapping catheter is used for three-dimensional mapping, and then an ablation catheter is used for ablation. It is impossible to complete all operations with a single catheter.

[0048] During the ablation phase, the catheter needs to be connected to both a 3D mapping system and the ablation device simultaneously, not just the ablation device alone. This is because the two devices are complementary, not substitutive. The ablation device delivers radiofrequency energy to the catheter, creating lesions in the myocardium for treatment. However, the ablation device itself lacks 3D localization and electrical signal acquisition capabilities, unable to provide the physician with the precise location of the catheter within the heart chambers or record the distribution of energy release points. If the catheter is only connected to the ablation device during ablation, the physician can release energy but cannot see the location distribution of ablation points in real time on the 3D reconstructed anatomical model, nor can they assess the ablation effect based on changes in local electrical signals. In contrast, the 3D mapping system continuously tracks the spatial position of the catheter, acquires electrophysiological signals, and instantly marks the corresponding points for each ablation on the 3D heart chamber model, ensuring the physician has full-process visual navigation and efficacy feedback. Therefore, only when the catheter is connected to both the 3D mapping system and the ablation device can energy output be combined with real-time localization and signal acquisition, ensuring the accuracy and safety of the operation. Therefore, during the ablation process, the existing ablation catheter not only transmits radiofrequency energy, but its electrodes also collect electrical signals from the heart chambers and transmit these signals to the three-dimensional mapping system.

[0049] However, although existing ablation catheters can perform mapping and ablation simultaneously to some extent during ablation, their limited number of electrodes, sparse mapping points, and spatial resolution and signal coverage are far inferior to dedicated mapping catheters, resulting in extremely low mapping efficiency and failing to meet clinical needs for three-dimensional mapping. On the one hand, collecting mapping data point-by-point within the heart chambers using the catheter is a cumbersome and time-consuming process; relying solely on this type of catheter for mapping often requires a long operation time. On the other hand, due to the limited number of acquisition points and insufficient spatial coverage, the obtained mapping results are unsatisfactory in terms of accuracy and completeness.

[0050] To address the aforementioned issues of low efficiency, poor continuity, and high operational difficulty in existing technologies, the core concept of this application lies in achieving multifunctional integration and operational flexibility through innovative design of the catheter's structure and energy control methods. On one hand, the catheter adopts an integrated "multipolar mapping + ablation" structural design, enabling physicians to perform multipolar electrophysiological mapping, three-dimensional anatomical modeling, and ablation operations on the same instrument, avoiding the efficiency losses caused by frequent instrument changes and allowing for more precise identification of abnormal myocardial regions. On the other hand, the catheter supports flexible selection of point-like or linear ablation patterns and can switch between unipolar and bipolar modes, thus accommodating the needs of different anatomical sites and ablation strategies. Simultaneously, the ablation energy can be selected between pulsed electric field ablation (PFA) and radiofrequency ablation (RF) to adapt to the tissue characteristics and clinical procedures of different cardiac locations, significantly improving operational adaptability and overall efficacy.

[0051] The following description is in conjunction with the accompanying drawings.

[0052] Please refer to Figure 1 The diagram illustrates a structural example of an ablation catheter provided in an embodiment of this application. Figure 1 As shown, the ablation system includes an ablation catheter 100 and an ablation device (not shown). The ablation catheter 100 includes a first end 101 (also referred to as the distal end of the ablation catheter) for abutting the target tissue to be ablated, a second end 102 (also referred to as the proximal end of the ablation catheter) for connecting to the ablation device, and a catheter body 103 located between the first end 101 and the second end 102. The ablation catheter 100 is tubular. A handle 200 is also included between the second end 102 and the ablation device. During the procedure, the physician can precisely control the ablation catheter 100 by manipulating the handle 200. The first end 101 includes an electrode group with at least 10 electrodes. The electrode group is configured to acquire electrocardiogram (ECG) signals in the space where the target tissue is located and transmit the ECG signals to a three-dimensional cardiac electrophysiological mapping system so that the three-dimensional cardiac electrophysiological mapping system can model and map the heart based on the ECG signals. In addition, the electrode group is also configured to receive control signals from the ablation device and ablate the target tissue using radio frequency energy or pulse energy according to the control signals. Each electrode in the electrode group has the ability to acquire ECG signals and ablate the target tissue.

[0053] The ablation catheter has a tubular structure, allowing it to simultaneously accommodate signal transmission leads and energy transmission pathways within a limited space. This enables the catheter to achieve both efficient acquisition of ECG signals and stable transmission of ablation energy. Compared to catheters of other shapes, the tubular structure offers flexibility and maneuverability, allowing for flexible operation within blood vessels and cardiac chambers, and better adherence to target tissue, facilitating simultaneous ablation and mapping. Furthermore, at least 10 electrodes are located at the first end. Experimental results show that when the number of electrodes is less than 10, the acquired ECG signals are insufficient in terms of spatial coverage and accuracy for modeling and mapping. By using at least 10 electrodes, not only is sufficient signal density guaranteed, improving the accuracy of modeling and mapping in the three-dimensional cardiac electrophysiological mapping system, but each electrode also performs both ablation and mapping functions.

[0054] Please refer to Figure 3 This illustrates a structural example of another ablation catheter provided in an embodiment of this application. Figure 3 As shown, the ablation system also includes a bending control handle 210 disposed between the second end 102 and the ablation device, and the first end 101 is an adjustable bend; the first end 101 swings around a first point X under the control of the bending control handle 210 to determine a mapping area S, where the first point X is the connection point between the first end 101 and the catheter body 103; wherein, the range of a mapping area S is determined by the first point X, the length of the first end 101 and the degree of bending of the first end 101, to form a mapping area similar to a fan shape. Figure 3 A and B in the diagram represent the two bending directions at the first end. During use, the doctor can control the bending handle 210 to achieve bidirectional bending.

[0055] The bending control handle 210 in this application can precisely drive the bending of the first end 101 through a mechanical transmission structure, thereby achieving multi-directional bending control of the distal end of the catheter. During the operation, the doctor can flexibly adjust the bending angle and direction of the first end 101 by simply rotating or pushing the bending control handle 210, enabling it to swing and be positioned over a wide range within the heart chambers or blood vessels. Unlike traditional point-based or linear ablation catheters, which typically require moving the catheter point by point and drawing ablation lines point by point, this application drives the first end 101 to swing around the first point X through the bending control handle 210, which can cover a mapping area S at once, significantly improving the efficiency of mapping and ablation. In clinical applications, doctors can change the catheter position according to the actual situation, thereby determining multiple mapping areas S and quickly forming continuous ablation foci or ablation lines, reducing operation time. At the same time, the bending control handle 210, in conjunction with the adjustable bending section of the first end 101, makes the distal end of the catheter more flexible and operable, enabling high-precision mapping and ablation operations to be performed in complex cardiac chamber structures.

[0056] In other embodiments of this application, the bending control handle 210 is an integrated mechanical bending and locking structure, capable of precise two-dimensional (up / down / left / right) or quasi-three-dimensional control of the first end 101. The bending control handle 210 includes: a slider or thumb wheel for axial pushing and pulling, a cross-type rocker / knob for orientation switching, a locking element for angle holding (e.g., ratchet / paddle / ball spring mechanism), and an angle scale display and zero-point reset mechanism. The doctor drives the internal traction wire (or nickel-titanium shape memory alloy wire) to move in the guide wheel / groove inside the handle by rotating the thumb wheel or pushing the slider; the front end of the traction wire is anchored to different quadrants of the first end 101 (usually two opposing wires or four cross-arranged wires), and the rear end is connected to the drive drum. The forward and reverse rotation of the drum generates tension in the corresponding directions, causing the adjustable bending section to bend controllably around the first point X. To avoid rebound and lag, the bending control handle 210 is equipped with a low-friction bushing and a pre-tension spring along the transmission path, which, together with a mechanical limit ring, controls the maximum bending angle to prevent damage to the traction wire and catheter wall from excessive bending. The locking element can lock instantaneously after reaching the desired angle, ensuring that the bending angle is stable and does not drift; when it needs to be released, the doctor can smoothly return it to zero by moving the unlocking tab. Through the above structure, the first end 101 can achieve small-radius, repeatable quantitative bending, and the torque is efficiently transmitted along the braided / wound reinforcement layer of the catheter body 103, resulting in sensitive and stable distal response.

[0057] The adjustable bending section can be made of materials such as a multi-lumen polymer tube (e.g., Pebax / PU) with an embedded stainless steel braided mesh or flat wire winding layer to balance torsional and flexural strength. Each lumen houses a multi-electrode lead, an energy transmission conductor, an infusion channel, and a traction wire channel. Each traction wire is anchored distally in a ring or "cross" pattern to ensure uniform curvature and predictable bending. Proximal, a differential drum structure enables composite bending, allowing physicians to achieve high-coverage scanning and apposition without repeated catheter insertion and withdrawal. Even with continuous contact between the first end 101 and the target tissue, the locking angle remains stable, reducing displacement caused by cardiac cycles and blood flow shear.

[0058] Based on the aforementioned bending control capability, the first end 101, driven by the bending control handle 210, swings in a fan shape or spatially around the first point X, capable of covering a mapping area S in one go. The range of the mapping area S is determined by the position of the first point X, the effective length of the first end 101, and its achievable bending angle (including the radius of curvature). Unlike the traditional point-by-point operation of "point-by-point movement and energy release," this embodiment uses a "fixed angle-sweep" method to complete the electrophysiological acquisition and ablation marking of multiple points within the area S in a short time, achieving a "point-to-surface" work unit. Doctors can change the overall orientation of the catheter or its advancement / retraction position as needed, based on the anatomy of the cardiac chambers and the distribution of lesions, sequentially determining multiple mapping areas S1, S2, etc., to quickly cover the target cardiac chambers in a splicing manner. This process significantly shortens the positioning and confirmation time, reduces the risk of complications caused by repeated insertion and removal and large displacement, and provides a continuous and dense reference path for subsequent linear or annular ablation.

[0059] The wide range of swaying characteristics of the first end 101, combined with the high-density arrangement of the electrode group (≥10 electrodes), makes "simultaneous mapping and ablation" a standard operational approach: when abnormal electrical activity is detected at any point within region S, the system can directly call the corresponding electrode (or electrode group) to perform point / linear ablation while maintaining or finely adjusting the current curvature angle, without waiting for full-cavity mapping to be completed before switching instruments and postures. Due to stable torque transmission, lockable angle, and repeatable curvature, doctors can complete the "confirmation-processing-re-examination" closed loop under the same geometric configuration, improving real-time performance and consistency.

[0060] Thus, the bending control handle 210 achieves precise bending control of the first end 101 through predictable traction transmission, low-friction guidance, angle locking, and limit protection. In conjunction with the multi-lumen reinforced tubular catheter body 103 and the dense electrode array, it enables a working mode that "defines the mapping area S by oscillation, ensures repeatability by locking, and enhances real-time performance through in-situ ablation." Compared to traditional point / linear catheters that can only move point by point, this structure has significant advantages in coverage efficiency, positioning accuracy, maneuverability, and clinical safety.

[0061] Please refer to Figure 15 The image shows a physical diagram of an ablation catheter according to an embodiment of this application. In addition to a controllable bending section at the first end, the first end also includes a pressure sensor. The first end comprises a flexible section and a rigid section. The pressure sensor and at least two electrodes are disposed in the rigid section, while the remaining electrodes in the electrode group are disposed in the flexible section. That is, the first end can be divided into two parts according to stiffness: a flexible section and a rigid section. The pressure sensor and at least two electrodes are disposed on the rigid section, and the remaining electrodes are disposed on the flexible section. Figure 15In this ablation catheter, the rigid segment has four electrodes and a pressure sensor, while the flexible segment has six electrodes. However, this application does not limit the ratio of electrodes on the two segments. For example, three electrodes can be provided on the rigid segment and seven on the flexible segment; or five electrodes can be provided on the rigid segment and five on the flexible segment. Furthermore, in this application, the working efficiency of the ablation catheter can be improved by providing more electrodes on the flexible segment. Figure 15 As can be seen, there are still many unused areas in the flexible section. These areas can be used to set a certain number of electrodes. The specific number can be set according to the user's needs, and this application does not impose any restrictions on this.

[0062] Thus, this application achieves "one tube for two uses" through the combination of the three technical features disclosed above. Specifically, the three technical features are: (1) the number of electrodes in the electrode group is greater than 10; (2) the distal end of the conduit (i.e. the first end) is a controllable bend, specifically divided into a flexible section and a rigid section, and the pressure sensor is set in the rigid section; (3) a certain number of electrodes are also set on the flexible section; if it is necessary to expand the number of electrodes, the corresponding number of ring electrodes can be directly added to the flexible section; in addition, the ratio of the number of electrodes in the flexible section and the rigid section can be changed.

[0063] First, the electrode array contains more than 10 electrodes, a fundamental requirement for efficient mapping. Compared to existing ablation catheters which typically have only a few electrodes (e.g., four), this application significantly increases the number of electrodes, enabling the simultaneous acquisition of a large number of intracardiac electrical signals and ensuring spatial resolution and signal coverage approaching that of dedicated mapping catheters. Second, the distal end of the catheter features a controllable bend, divided into a flexible and a rigid section, with a pressure sensor located in the rigid section. The controllable bend design allows physicians to flexibly manipulate the catheter tip for extensive intracardiac scanning, greatly improving mapping efficiency. The pressure sensor, located in the rigid section, can monitor the contact status in real time during ablation or mapping, preventing signal distortion or ineffective ablation due to poor contact. If located in the flexible section, excessive deformation could lead to unstable detection. Finally, the placement of electrodes in the flexible section allows for further expansion of the electrode count. For example, by adding ring electrodes or adjusting the ratio of electrodes in the flexible to rigid sections, the coverage density of mapping points can be further improved, achieving sampling capabilities closer to dedicated mapping catheters. This synergistic arrangement of flexible and rigid electrodes ensures both the breadth and accuracy of the mapping, while also taking into account the stability and safety of the ablation operation.

[0064] Therefore, the catheter in this application is not simply an ablation catheter with some mapping functions "attached" to it. Rather, through a sufficient number of electrodes, a rationally segmented distal structure combined with a pressure sensor, and a synergistic design of flexible and rigid electrode segments, it achieves mapping efficiency comparable to dedicated mapping catheters, thus truly possessing the practical value of "one catheter for two purposes." Compared with existing technologies, this solution can achieve both efficient mapping and effective ablation in a single catheter, avoiding the cumbersome process of having to sequentially change the mapping catheter and ablation catheter in traditional surgery. It also solves the fundamental deficiency of existing ablation catheters, which, although capable of mapping, have extremely low efficiency and cannot meet clinical needs.

[0065] Furthermore, each electrode in the electrode assembly is capable of simultaneously acquiring ECG signals and ablating target tissue, maximizing the actual range of mapping and ablation, and enabling simultaneous mapping and ablation. When abnormal electrical signals or lesions are detected during mapping, ablation can be performed directly without waiting for the entire mapping process to complete. Compared to traditional methods that require mapping first and then ablation separately, this approach offers better real-time performance and targeting, allowing for immediate resolution of problems upon discovery, thus significantly improving surgical efficiency and treatment outcomes.

[0066] After the ablation catheter acquires the electrocardiogram (ECG) signal from the target tissue, this signal is transmitted to a three-dimensional cardiac electrophysiological mapping system. This system combines catheter location information and the ECG signal to generate a three-dimensional electroanatomical model of the heart, displaying the distribution of electrical activity in real time. This helps physicians visually assess the electrophysiological characteristics of different myocardial tissues and locate myocardial regions with abnormal conduction or pathogenic return pathways. This modeling and mapping method effectively improves the accuracy of lesion site identification, providing a reliable basis for subsequent ablation treatment.

[0067] During ablation therapy, the ablation catheter can deliver radiofrequency energy or pulsed energy to the target tissue. Radiofrequency energy is used in scenarios requiring persistent scarring to effectively ablate and isolate abnormal myocardial tissue; while pulsed energy is more suitable for situations requiring selective destruction of cardiomyocytes while minimizing the risk of damage to adjacent tissues. Radiofrequency energy is suitable for creating persistent scars because the thermal effect generated by the current can cause stable and deep coagulative necrosis in the myocardial tissue, forming a continuous scar barrier that helps block the conduction pathways of abnormal electrical signals. Pulsed energy, on the other hand, relies on short, high-intensity electrical pulses to alter cell membrane permeability (electroporation effect), thereby selectively destroying cardiomyocytes without relying on significant thermal damage. Because this mechanism causes less damage to non-myocardial tissues (such as the esophagus, phrenic nerve, or coronary arteries), it is more suitable for use in scenarios where there are concerns about damage to surrounding sensitive structures. The ablation catheter of this application can be selectively applied between radiofrequency ablation and pulsed ablation modes according to actual treatment needs, thus possessing strong versatility and flexibility, and covering a wider range of clinical applications.

[0068] The ablation device is configured to transmit radiofrequency energy to the ablation catheter to perform radiofrequency ablation on the target tissue, or the ablation device is configured to transmit pulse energy to the ablation catheter to perform pulse ablation on the target tissue; and the control signal transmitted by the ablation device to the ablation catheter further includes a first sub-control signal and a second sub-control signal. The first sub-control signal is used to control the electrodes in the electrode group to ablate the target tissue in a unipolar mode or a bipolar mode. In the unipolar mode, all electrodes selected for ablation in the electrode group output positive signals. In the bipolar mode, the electrodes selected for ablation in the electrode group include at least one electrode that outputs a positive signal and at least one electrode that outputs a negative signal. The second sub-control signal is used to control the electrodes in the electrode group to perform point ablation or linear ablation on the target tissue.

[0069] The ablation device in this application is designed to allow for flexible adjustment of the ablation catheter's operating mode under the physician's control, adapting to the treatment needs of different types of arrhythmias and different lesion conditions in clinical practice. For example, the ablation device can transmit different types of energy to the ablation catheter: on the one hand, it can choose to transmit continuous radiofrequency energy, enabling the electrodes to perform traditional radiofrequency ablation on the target tissue; on the other hand, it can also choose to transmit pulsed energy, thereby achieving pulsed ablation to meet the safe treatment requirements of some special lesions (such as adjacent conduction bundles or blood vessels).

[0070] In some embodiments, the ablation device is an integrated device that can selectively output either radio frequency energy or pulsed energy. In other embodiments, the term "ablation device" in this application is a general term for ablation equipment, which includes a radio frequency device and a pulsed ablation device, wherein the radio frequency device is used to output radio frequency energy and the pulsed ablation device is used to output pulsed energy.

[0071] Building upon energy transmission, the control signals of the ablation device further include a first sub-control signal and a second sub-control signal. The first sub-control signal is used to select the ablation mode as unipolar or bipolar ablation. In unipolar mode, all selected electrodes in the electrode group operate as positive electrodes, and energy is channeled through a closed loop via the external dorsal electrode or reference electrode to form deep, widespread lesions. In bipolar mode, at least one electrode in the electrode group acts as a positive electrode and at least one as a negative electrode, directly closing the current path between the electrodes to form a relatively concentrated and controllable ablation area, making it more suitable for ablation of adjacent important anatomical structures. The second sub-control signal is used to select the ablation method as point ablation or linear ablation. In point ablation, the current is concentrated at a single electrode point, suitable for precise treatment of focal lesions; while in linear ablation, a group of electrodes arranged in a specific pattern can be selected simultaneously to form a continuous linear injury zone on the myocardial surface, used to block macroreentrant pathways.

[0072] It is important to note that point ablation and linear ablation have significant differences in application and specific targets. Point ablation refers to the concentrated energy output from a single or a small number of electrodes at a localized location in the target tissue, forming a limited ablation foci on the tissue surface or at a certain depth. Its characteristics include precise positioning and a small lesion area, making it suitable for treating focal lesions (such as local abnormal electrical conduction points). It can achieve targeted ablation of lesions while preserving as much surrounding normal myocardial tissue as possible. Linear ablation, on the other hand, uses a group of electrodes arranged in a specific pattern to simultaneously output energy, forming a continuous linear lesion band on the myocardial surface, thus constructing an "intercepting band" for electrical conduction. It is often used to block large-scale macroreentrant pathways or cut off abnormal circuits. Compared to point ablation, linear ablation can complete a larger area of ​​electrical conduction isolation in one procedure, reducing operation time and improving operational efficiency. The flexible switching between the two modes allows for both local precision and overall blockage in the ablation foci pattern, significantly improving the therapeutic effect and clinical adaptability of ablation surgery.

[0073] Through the flexible combination of the above energy types, unipolar / bipolar modes, and point / linear methods, the ablation device and ablation catheter can theoretically provide eight different ablation combinations, thereby greatly improving the clinical adaptability of the system under different lesion types and different anatomical regions. Doctors can adjust the ablation strategy in real time according to the patient's condition.

[0074] It is important to emphasize that a core innovation of this application lies in the fact that the entire system does not merely improve a single component such as the ablation catheter or ablation device, but rather achieves a high degree of integration of energy control, polarity control, and ablation mode control through the coordinated design between the ablation catheter and the ablation device. This systematic design allows the ablation system to be deeply integrated with a three-dimensional cardiac electrophysiological mapping system, enabling simultaneous mapping and ablation during the procedure and flexible adjustment of treatment strategies. Therefore, the overall solution provided by this application has greater clinical versatility, can adapt to the complex and ever-changing needs of arrhythmia treatment, and significantly improves the real-time nature, safety, and effectiveness of the procedure.

[0075] Please refer to Figure 2 This illustrates a method of using an ablation system provided in an embodiment of this application. For example... Figure 2 As shown, during ablation, the physician first selects the type of ablation energy based on the surgical needs, choosing either radiofrequency or pulsed energy. Next, they select the ablation modality, either unipolar or bipolar ablation. Finally, they select the ablation shape based on the lesion characteristics, which can be either point ablation or linear ablation. Through this step-by-step selection process, physicians can flexibly configure different ablation modes within the same system, achieving a comprehensive combination from energy type to action mode to lesion shape. This method not only improves the intuitiveness and controllability of the operation but also has high versatility in clinical application, covering a variety of clinical situations from focal lesion treatment to large-scale conduction blockade, providing a unified platform for the treatment of different types of arrhythmias.

[0076] The term "versatility" refers to the ability of a single catheter to adapt to the clinical needs of different patients and the varied lesion conditions. In existing technologies, physicians often need to select different models or structures of ablation catheters based on the size, location, and pathological characteristics of the lesions. This not only increases the complexity of preoperative preparation and instrument management but also easily leads to poor surgical outcomes or even failure due to inappropriate catheter selection, increasing clinical risks. This application proposes a new ablation system based on this pain point. Figure 2As shown, theoretically, eight different ablation results can be achieved, covering different ablation energies, ablation methods, and ablation shapes, far exceeding the single output mode of catheters in existing technologies. By receiving external control signals, the catheter can flexibly switch ablation methods and shapes as needed, such as point ablation, linear ablation, or area ablation, thereby addressing diverse treatment needs in the same surgical procedure. Furthermore, the ablation device of this application can selectively transmit radiofrequency energy or pulsed energy to the catheter, enabling the catheter to achieve more precise and efficient treatment results under different lesion types. Therefore, the technical solution of this application not only reduces the burden on doctors preparing multiple catheters for different surgical scenarios but also significantly improves the applicability and application efficiency of ablation catheters in clinical practice, ensuring the consistency and safety of the surgery.

[0077] In some embodiments of this application, when the first sub-control signal controls the electrodes in the electrode group to ablate in unipolar mode, the ablation device sets the second sub-control signal to perform point ablation on the target tissue; and in other embodiments of this application, when the first sub-control signal controls the electrodes in the electrode group to ablate in bipolar mode, the ablation device sets the second sub-control signal to perform linear ablation on the target tissue. Point ablation is preferably unipolar ablation because the ablation foci formed by unipolar ablation are deeper and can effectively penetrate the target tissue, while its electric field morphology has less impact on surrounding tissues, which helps to improve the stability and safety of the operation. Linear ablation can be performed in either unipolar or bipolar mode, but bipolar ablation is preferred because bipolar ablation produces less muscle stimulation, thereby reducing the patient's pain during treatment. Although unipolar point ablation is widely used in many clinical scenarios, unipolar linear ablation is also meaningful in other cases. For example, when a deep and continuous ablation line is needed along specific cardiac anatomical structures (such as the mitral isthmus, tricuspid annulus, or the apex of the left atrium), unipolar linear ablation can provide stronger tissue penetration, facilitating more thorough electrical conduction blockade in these thick-walled or complex structures. In this mode, the electrode selected as the positive pole on the catheter forms multiple independent loops with the dorsal electrode on the body surface, thus accumulating point by point to achieve a continuous linear ablation band. On the other hand, bipolar mode can also be used to achieve point ablation for some small lesions requiring precise local treatment. For example, when near thin-walled areas of the atrium or adjacent to important structures (such as the pulmonary vein ostia or the atrioventricular node), physicians may want to concentrate energy between adjacent electrodes on the catheter to reduce interference with distal tissues. In this case, at least one local loop is formed between the electrode on the catheter that outputs a positive signal and the electrode that outputs a negative signal, thereby achieving bipolar point ablation. This approach can reduce damage to non-target tissues while ensuring ablation effectiveness, further improving the safety and controllability of the procedure.

[0078] Furthermore, in some embodiments of this application, the ablation device automatically matches the ablation method with the ablation shape according to a preset logical relationship, thereby simplifying the doctor's operation. For example, when the unipolar mode is selected, the ablation device will automatically default to point ablation; when the bipolar mode is selected, the ablation device will automatically default to linear ablation. This default matching not only reduces the steps for doctors to manually set during surgery and improves operational efficiency, but also reduces the risk of errors caused by manual selection in emergency or complex surgical procedures, thereby improving the overall treatment safety and consistency. Of course, in special clinical situations, such as the scenarios listed in the above embodiments, doctors can still manually modify the ablation shape according to actual needs to provide more flexible treatment for different lesion characteristics. Therefore, this design ensures both the intelligence and convenience of the system and retains the flexibility of manual intervention, taking into account most common clinical scenarios and personalized needs.

[0079] In some embodiments of this application, the control signal further includes a third sub-control signal, which is used to determine the number and position of the electrodes used for ablation in the electrode group. That is, during the procedure, the surgeon can freely select any electrode in the electrode group on the first end for ablation. The discharge between the electrodes in this embodiment is independent of each other, so electrode discharge can be selected according to actual needs. One or more discharge electrodes can be selected for ablation while other electrodes do not discharge; alternatively, all electrodes can be selected to discharge simultaneously. For examples, please refer to [link to example]. Figure 1 The doctor can select electrodes 1, 3, 5, 7, and 9 for ablation, while turning off electrodes 2, 4, 6, 8, and 10. This is just an example to illustrate that the selection of electrodes can be freely set according to the doctor's needs.

[0080] In existing technologies, some ablation catheters often only allow the electrodes to conduct as a whole and operate simultaneously during ablation, lacking the ability to independently control individual electrodes. For example, some common unipolar ablation catheters have an integrated electrode design, requiring all electrodes to conduct simultaneously for energy release, making precise local selection impossible during ablation. Similarly, some multipolar ablation catheters, while possessing multiple electrodes, lack individual control functionality in their electrode drive circuits, only allowing for group triggering and failing to achieve independent operation at the electrode level. Furthermore, while some relatively advanced catheters support multipolar ablation, they typically employ fixed electrode combinations, still lacking flexibility and struggling to address complex arrhythmia lesions.

[0081] In contrast, the ablation catheter in this embodiment can achieve precise management of each electrode on its first end through circuit control, matrix switch control, or an integrated electrode selection module. With the assistance of mapping electrodes, the physician can identify the locations of abnormal and normal myocardial tissue, and then select only the electrodes located in the abnormal myocardial region for energy release, while shutting off the electrodes located in the normal myocardial tissue. In this way, targeted ablation of the lesion area can be performed, ensuring both thoroughness and effectiveness of the ablation while minimizing thermal damage to normal myocardial tissue, reducing the risk of postoperative complications, and thus significantly improving the safety and success rate of the ablation procedure.

[0082] One relatively easy-to-implement method is to incorporate an independently controllable switch array within the catheter handle or connecting module, controlling the on / off state of each electrode in a matrix manner. This allows the surgeon to precisely activate electrodes located in areas of abnormal myocardial tissue during surgery, while simultaneously deactivating electrodes in corresponding normal myocardial tissue areas, based on mapping results. For example, if mapping shows lesions below electrodes 3 and 5, while the tissue below electrodes 4 and 6 is normal, the surgeon can activate only electrodes 3 and 5 for radiofrequency ablation, while keeping electrodes 4 and 6 deactivated, achieving precise local ablation and minimizing damage to normal tissue. Alternatively, a multi-channel radiofrequency generator can be used for individual control, with each electrode corresponding to a separate channel, enabling differentiated control at the source. Another approach is electrode group control, where electrodes are pre-divided into several logical groups, each independently operable, allowing the surgeon to select the desired group during surgery. While both methods achieve differentiated electrode control, the switch array approach is more mature, flexible, and clinically valuable due to its lower system complexity and scalability considerations.

[0083] In some embodiments of this application, the ablation system further includes an adapter box, which is connected to the ablation device, the three-dimensional cardiac electrophysiological mapping system, the ablation catheter, and the back electrode patch, respectively. The adapter box is used to select the path of radiofrequency ablation or pulse ablation between the ablation device and the ablation catheter, transmit the data acquired by the ablation catheter during the operation to the three-dimensional cardiac electrophysiological mapping system, and construct a loop between the ablation catheter and the back electrode patch in unipolar mode.

[0084] In the dual-energy implementation mode, two independent energy sources (pulse ablation device and radiofrequency device) can be connected to the same adapter box. This adapter box is connected to the ablation catheter via a catheter tail wire, allowing the pulse ablation device and radiofrequency device to communicate through the same adapter box and catheter. This enables the selective transmission of pulse energy or radiofrequency energy to the catheter tip for ablation. In the specific application of this system, pulse ablation can be performed when the pulse ablation device is activated; radiofrequency ablation can be performed when the radiofrequency device is activated.

[0085] Furthermore, when a functional expansion module is set in the adapter box of the dual-energy system, a variety of additional functions can be realized. For example: 1) When a back electrode patch connection module is set in the adapter box, both the pulse ablation device and the radiofrequency device can be connected to the back electrode patch to achieve unipolar discharge; 2) When a three-dimensional cardiac electrophysiological mapping system connection module is set in the adapter box, the ablation catheter can be connected to the three-dimensional mapping system through the adapter box, thereby directly performing mapping or modeling during the ablation process and displaying relevant ablation parameters in real time, such as catheter tip contact pressure, impedance value, number of ablations, and ablation time.

[0086] In addition, the system can be equipped with dual-energy discharge protection and control mechanisms. For example, the pulse ablation function can be prohibited during radiofrequency ablation, and the radiofrequency ablation function can be prohibited during pulse ablation, so as to avoid the two energy sources being accidentally triggered during clinical ablation, thereby significantly improving the safety of dual-energy ablation.

[0087] Thus, the adapter box allows for flexible selection of either radiofrequency ablation or pulsed ablation pathways between the ablation device and the ablation catheter, enabling the same catheter to switch between different ablation energy types as needed, thereby improving the diversity and adaptability of ablation methods. Furthermore, the adapter box can transmit signals acquired by the ablation catheter to the 3D cardiac electrophysiology mapping system in real time for modeling and mapping, maintaining the catheter's dual function during surgery. In addition, the adapter box can automatically establish a circuit between the ablation catheter and the back electrode patch in unipolar mode, avoiding complex external connection operations by the physician during the procedure. In summary, the introduction of the adapter box not only simplifies the connection between the catheter, ablation device, and 3D system, improving the overall operational convenience and stability of the system, but also further enhances the catheter's application capabilities in various clinical scenarios.

[0088] Please refer to Figure 4-14 These images illustrate the ablation effect of the ablation catheter disclosed in the embodiments of this application. Figures 4-9 In the image, the shape of the ablation site is represented below the black horizontal line. Figure 4 Corresponding to unipolar point ablation, Figure 5 Corresponding to bipolar ablation, Figure 6 Corresponding to unipolar linear ablation (discharge of all electrodes). Figure 7 Corresponding to bipolar linear ablation (discharge of all electrodes). Figure 8 Corresponding to unipolar linear ablation (partial electrode discharge). Figure 9 This corresponds to bipolar linear ablation (partial electrode discharge). The concepts of point ablation, linear ablation, unipolar ablation, and bipolar ablation have been detailed in the above embodiments and will not be repeated here. Figures 4 to 9It is evident that this application, by enabling free combinations of unipolar and bipolar ablation, and point-like and linear ablation, can flexibly create ablation foci of different shapes and sizes. For example, when targeting a small localized area of ​​myocardial tissue, unipolar point-like ablation can be used to create a relatively independent small ablation foci; while when dealing with larger lesions, bipolar linear ablation can rapidly create continuous band-like ablation foci. Furthermore, in certain complex lesion areas, physicians can choose multi-point combinations or point-line combinations based on mapping results, thereby achieving personalized ablation plans that better meet actual clinical needs. Additionally, appropriate electrode discharge can be selected during the ablation process based on the actual situation. Therefore, the ablation catheter provided by this application has higher versatility and flexibility in adapting to different clinical scenarios.

[0089] exist Figure 10-14 middle, Figure 10-12 Potatoes were selected as the sample for the experiment. Figure 13 and Figure 14 Isolated hearts from deceased animals were selected as samples for the experiment. Monopolar and bipolar point-pulse ablation were performed on potatoes, and the ablation results are as follows. Figure 10 As shown, the experimental conditions for unipolar and bipolar ablation were completely identical (i.e., the same pulse ablation parameters, the same potato, the same saline concentration, etc.). The catheter tip (or the head electrode, i.e., electrode 1) was perpendicularly placed against the potato. The discharge voltage was set to 1800V, and the discharge time was set to 5s. The shape of the potato ablation foci was similar to the simulation results; the surface of the potato ablation foci was approximately elliptical or circular. The depth of the unipolar ablation foci was 6.8mm, and the depth of the bipolar ablation foci was 4.2mm. Therefore, it can be seen that under the same ablation parameters, the depth of the unipolar ablation foci is greater than that of the bipolar ablation foci.

[0090] Bipolar pulse ablation was performed on the potato, and the ablation results are as follows. Figure 11 As shown. For bipolar linear ablation, electrodes 1, 2, 5, 7, and 9 were selected as positive electrodes, and electrodes 3, 4, 6, 8, and 10 as negative electrodes. The catheter tip was horizontally placed against the potato, and the discharge voltage was set to 900V. The shape of the potato ablation foci was similar to the simulation results; the potato ablation foci were distributed in a single strip along the direction of the catheter electrodes, with a length of approximately 41.9 mm. Furthermore, the potato ablation foci near the distal electrode of the catheter tip were deeper (approximately 6.1 mm), while those near the proximal ring electrode were shallower (approximately 2.1 mm).

[0091] Six electrodes near the proximal end of the catheter were used for bipolar pulse ablation on a potato. The catheter tip was placed horizontally against the potato, and the discharge voltage was set to 900V. Electrodes 5, 7, and 9 were selected as positive electrodes, and electrodes 6, 8, and 10 were selected as negative electrodes. The ablation results are as follows: Figure 12As shown, the shape of the potato ablation furnace is similar to the simulation results. The potato ablation furnace is approximately elongated, with a length of about 26.0 mm and a depth of about 4.0 mm.

[0092] Monopolar pulse ablation was performed on a live pig, and the ablation results are as follows: Figure 13 and Figure 14 As shown. Monopolar ablation uses electrode 1 to discharge to the back electrode, with the discharge voltage set to 1500V and the contact force to be about 40g. The surface of the potato ablation foci is approximately elliptical or circular, and the depth of the ablation foci is about 10~11mm.

[0093] from Figure 10-14 It can be seen that the ablation system of this application has a similar ablation effect to the simulation effect on actual samples (potatoes or animal hearts), and has extremely high clinical value.

[0094] In some embodiments of this application, the number of electrode groups is between 10 and 20, and each electrode group includes a head electrode and several ring electrodes. The head electrode is disposed at the distal end of the first end, and the several ring electrodes are arranged along the direction from the distal end to the proximal end of the first end. A pressure sensor is used to transmit pressure data between the first end and the target tissue in real time to a three-dimensional cardiac electrophysiological mapping system, so that the three-dimensional cardiac electrophysiological mapping system can determine the contact status of the first end. The width of the head electrode ranges from 1.5 mm to 5 mm, the width of each ring electrode ranges from 0.3 mm to 3 mm, the diameter of each electrode in the electrode group ranges from 2 mm to 4 mm, and the spacing between two adjacent electrodes, except for the spacing between two electrodes adjacent to the pressure sensor, ranges from 1 mm to 5 mm. The spacing between two electrodes adjacent to the pressure sensor is determined by the size of the pressure sensor.

[0095] Please continue to refer to this. Figure 1 Electrode 1 can be called the head electrode, electrodes 2-10 can be called ring electrodes, and the pressure sensor is 11. Head electrode 1 is located at the distal end of the first end 101. The ring electrodes are arranged sequentially along the proximal end of the conduit, with electrode 2 being closest to electrode 1 and electrode 10 being furthest from electrode 1. (Except for...) Figure 1 In addition to the 10 electrodes shown, the total number of electrodes in the electrode group can be between 10 and 20. By setting the number of electrodes within this range, it is possible to ensure that the electrodes cover a sufficiently long distal area of ​​the catheter to accommodate ablation lesions of different lengths and sizes, thereby improving the flexibility of clinical applications. On the other hand, an excessive number of electrodes will increase the complexity of the catheter structure and the difficulty of manufacturing, and may also lead to problems such as wiring congestion and electrical interference. Therefore, limiting the number of electrodes to between 10 and 20 achieves a good balance between functionality and manufacturability.

[0096] The width of the head electrode ranges from 1.5mm to 5mm, ensuring effective transmission of radiofrequency ablation power while avoiding the reduced distal catheter flexibility caused by an excessively large head electrode or the insufficient ablation efficiency caused by an excessively small head electrode. The width of each ring electrode ranges from 0.3mm to 3mm, allowing the ring electrodes to form uniform and continuous mapping and ablation effects without reducing the resolution between ring electrodes due to excessive width. The electrode diameter is limited to 2mm to 4mm, ensuring sufficient electrode contact area while maintaining the overall minimally invasive characteristics of the catheter. Except for the spacing between the two electrodes adjacent to the pressure sensor, the spacing between adjacent electrodes ranges from 1mm to 5mm, with the spacing between the two electrodes adjacent to the pressure sensor determined by the size of the pressure sensor. This ensures good spatial resolution when multiple electrodes are working simultaneously while avoiding short circuits or overheating caused by electrodes being too close together, thus balancing safety and effectiveness.

[0097] In some embodiments of this application, at least one ring electrode is provided between the pressure sensor and the head electrode.

[0098] By introducing at least one loop electrode between the two electrodes, a reasonable electrode distribution can be maintained at the distal end of the catheter, forming a continuous electrical signal acquisition pathway. This avoids problems such as excessive electrode spacing and uneven signal acquisition that would occur if a pressure sensor were placed directly after the scalp electrode, thus preventing the loss or distortion of ECG signals. This structure significantly improves the accuracy and reliability of cardiac electrophysiological mapping, ensuring the clinical applicability of the catheter in mapping and modeling processes.

[0099] In some embodiments of this application, each electrode in the electrode group has an impedance detection function and is used to transmit the detected impedance data to the ablation device so that the ablation device can determine whether each electrode is in effective contact with the target tissue according to a preset impedance range; the three-dimensional cardiac electrophysiological mapping system is also used to determine whether the target tissue is abnormal myocardial tissue based on the data obtained from the first end mapping. During ablation, the ablation device defaults to selecting the electrode that is in effective contact and is in contact with the marked abnormal myocardial tissue for ablation.

[0100] During pulsed ablation, the adhesion between the catheter electrode and the tissue significantly affects the depth of the ablation foci. Generally, when the catheter electrode adheres well to the myocardial tissue, the depth of the pulsed ablation foci is significantly greater than when it is not in contact with the tissue. If the electrode fails to adhere effectively to the myocardial tissue, the discharge energy may be primarily released into the bloodstream. This not only makes it difficult to form an ablation foci of sufficient depth and stability in the target myocardial tissue, leading to increased risk of ablation failure or recurrence, but may also cause blood overheating, resulting in serious complications such as hemolysis and thrombosis. Therefore, ensuring effective adhesion between the electrode and the myocardial tissue and avoiding discharge under ineffective adhesion is crucial for improving the safety and effectiveness of ablation. To this end, this embodiment proposes a method based on impedance detection to determine the adhesion of multiple electrodes to the myocardial tissue. When the electrode is in contact with the myocardial tissue, its impedance value is generally between 200Ω and 250Ω; when the electrode is suspended in the blood, its impedance value is generally between 150Ω and 200Ω. If the impedance value deviates from the above range, it can be determined that there is an abnormality in the catheter. By comparing the impedance value obtained from the test with the preset impedance range, it is possible to clearly distinguish whether the electrode is well attached to the myocardial tissue.

[0101] When the impedance of one or more electrodes meets the impedance range required when in contact with the myocardium, it indicates good contact between these electrodes and the myocardial tissue, allowing for pulsed discharge. Conversely, when the impedance of one or more electrodes meets the impedance range required when suspended in the blood, it indicates poor contact between these electrodes and the myocardial tissue, disallowing pulsed discharge. This method can improve pulsed discharge efficiency while ensuring effective discharge and reducing the risk of complications such as hemolysis caused by ineffective discharge.

[0102] In this embodiment, due to the large number of electrodes, it is required that the selected ablation electrodes maintain good contact with the myocardial tissue during pulse ablation. To achieve this, all electrodes on the catheter can be connected to a special pulse ablation device, thereby enabling real-time impedance detection. When the impedance is within the required range, the ablation device allows pulse discharge; when the impedance exceeds the range, pulse discharge is prohibited. Furthermore, when the impedance detection results of some electrodes on the catheter show good contact, while the impedance detection results of the remaining electrodes show poor contact, the system can select only the electrodes with good contact for discharge, while preventing the electrodes with poor contact from discharging, thereby effectively improving ablation efficiency and avoiding the side effects caused by ineffective or incorrect electrode discharge.

[0103] Furthermore, the three-dimensional cardiac electrophysiological mapping system also determines whether the target tissue is abnormal myocardial tissue based on the signal returned from the first end. During ablation, only abnormal myocardial tissue is ablated, while normal myocardial tissue is not ablated. This can be achieved through the third sub-control signal in the above embodiment. That is, depending on the actual situation, after the mapping electrodes detect abnormal and normal myocardial tissue, only the electrodes mapping abnormal myocardial tissue are selected to discharge, while the electrodes mapping normal myocardial tissue are not discharged. The advantage is that it can achieve more precise local ablation and reduce damage to normal myocardial tissue.

[0104] In summary, this embodiment uses impedance detection to determine the adhesion between each electrode and myocardial tissue, and performs selective electrode discharge based on the detection results. This improves the efficiency of pulse ablation while ensuring the ablation effect and reduces the risk of complications caused by ineffective discharge.

[0105] In some embodiments of this application, after the catheter electrodes enter the heart chamber, impedance detection is first performed on each electrode to determine whether its impedance value is within a preset electrode contact impedance range. If the detection result shows that the impedance value is within this range, the system selects the electrode that meets the condition as the ablation electrode and initiates the pulse ablation operation; if the detection result shows that the impedance value is not within this range, it indicates that the electrode has not formed an effective contact with the myocardial tissue. At this time, the operator (i.e., the doctor) needs to adjust the catheter to improve the contact between the electrode and the myocardial tissue and re-perform the electrode impedance detection. The above steps can be repeated until the impedance value meets the required range before pulse ablation can be initiated. This process ensures that the ablation electrode discharges under an effective contact state, thereby improving the efficiency and safety of pulse ablation.

[0106] In some cases, relying solely on impedance detection can lead to misjudgments. For example, while some electrodes may detect impedance values ​​within the range required for effective contact with the myocardium, the electrodes may actually only be in slight contact with the myocardial surface, or the impedance values ​​may fluctuate briefly due to blood flow or tissue movement, leading the system to misjudge it as effective contact. By performing pressure detection simultaneously with impedance detection, it can be found that the pressure applied to the electrode is below 5g, which is below the range required for effective contact. Compared to the above embodiments, the addition of a pressure sensor allows for a more accurate and reliable determination of the contact between the ablation catheter and the target tissue, and it also allows for simultaneous determination of effective contact based on both impedance and pressure detection. During pressure detection, a pressure detected between 5g and 20g can be considered as effective contact.

[0107] Therefore, by combining impedance detection and pressure detection for dual determination, false positive results caused by single impedance detection can be avoided, ensuring that the ablation catheter truly forms a stable and reliable fit with the target tissue, and further improving the safety and accuracy of ablation.

[0108] In summary, integrating a pressure sensor at the distal end of the catheter can display the contact force between the electrode and myocardial tissue in real time. This not only provides the operator with intuitive and reliable information on the contact status, but also allows for cross-verification with impedance detection results. This enables a more accurate determination of whether the electrode is in an effective contact state during the ablation process, improving the safety of the procedure and the reliability of the ablation effect.

[0109] Please refer to Figure 16 The diagram illustrates a structural example of a head electrode (without an insulating sleeve) provided in an embodiment of this application. Please refer to... Figure 17 This illustrates a structural example of another head electrode (with an insulating sleeve) provided in an embodiment of this application. Figure 16 and Figure 17 As shown, the head electrode M has a protrusion N at one end near the pressure sensor (not shown in the figure). This application provides an insulating sleeve L between the protrusion N and the pressure sensor to achieve electrical insulation between them. Thus, the insulating sleeve effectively prevents excessive current from causing breakdown or damage to the pressure sensor during electrode operation, ensuring its long-term stable operation.

[0110] Without an insulating sleeve, since the protrusion needs to be connected to a wire and conduct to the electrode, when the electrode releases energy, current may couple or leak along the protrusion to the adjacent pressure sensor, causing the pressure sensor to be directly subjected to a high-voltage surge. On the one hand, this situation can easily cause insulation breakdown or device burnout in the sensor circuit; on the other hand, even if it is not immediately damaged, it will cause distortion and drift in the measurement signal, affecting the accuracy and reliability of pressure detection.

[0111] Please refer to Figure 18 This shows an enlarged view of the first end of an ablation catheter provided in an embodiment of this application. Figure 18 As shown, the rigid section also includes a protective sleeve Q, which at least surrounds the pressure sensor P, such that the pressure sensor P is located inside the protective sleeve Q, and the ring electrodes R on the rigid section are all located outside the protective sleeve. Furthermore, from... Figure 18 As can be seen, due to the setting of the insulating sleeve L, the pressure sensor P and the protrusion N of the head electrode M are electrically insulated, so as to achieve the goal of protecting the pressure sensor during electrode discharge.

[0112] In this embodiment, the protective sleeve is arranged at least around the pressure sensor, so that the pressure sensor is located inside the protective sleeve. This prevents the pressure sensor from directly contacting the myocardial tissue, avoiding signal interference and mechanical wear. On the other hand, it provides additional rigid support for the pressure sensor and its surrounding area, enabling the distal end of the catheter to better achieve the positioning and support functions of the rigid segment.

[0113] With its dual protection design of insulating sleeve and protective sleeve, the pressure sensor not only has electrical safety and stability, but also mechanical protection and structural reliability, thus significantly improving the overall durability and clinical applicability of the catheter.

[0114] In the above embodiments, the descriptions of each embodiment have their own emphasis. Parts not described in detail or in a particular embodiment can be referred to in the relevant descriptions of other embodiments. Furthermore, the above embodiments can be freely combined as needed.

Claims

1. An ablation system, characterized in that, The device includes an ablation catheter and an ablation device. The ablation catheter includes a first end for abutting against the target tissue to be ablated, a second end for connecting to the ablation device, and a catheter body located between the first end and the second end. The ablation catheter is tubular. The ablation device is configured to transmit radiofrequency energy to the ablation catheter to perform radiofrequency ablation on the target tissue, or the ablation device is configured to transmit pulse energy to the ablation catheter to perform pulse ablation on the target tissue; The first end portion includes an electrode assembly with at least 10 electrodes. The electrode assembly is configured to acquire electrocardiogram (ECG) signals from the space containing the target tissue and transmit these ECG signals to a three-dimensional cardiac electrophysiological mapping system. This allows the three-dimensional cardiac electrophysiological mapping system to model and map the heart based on the ECG signals. Furthermore, the electrode assembly is configured to receive control signals from the ablation device and, according to the control signals, ablate the target tissue using either radio frequency energy or pulse energy. Each electrode in the electrode assembly is capable of acquiring the ECG signals and ablating the target tissue. The ablation capability; wherein the control signal includes a first sub-control signal and a second sub-control signal, the first sub-control signal being used to control the electrodes in the electrode group to ablate the target tissue in unipolar or bipolar mode, in the unipolar mode, all electrodes selected for ablation in the electrode group output positive signals, in the bipolar mode, the electrodes selected for ablation in the electrode group include at least one electrode outputting a positive signal and at least one electrode outputting a negative signal, the second sub-control signal being used to control the electrodes in the electrode group to perform point ablation or linear ablation on the target tissue; Furthermore, the ablation system also includes a bending control handle disposed between the second end and the ablation device, and the first end is an adjustable bending section; the first end swings around a first point under the control of the bending control handle to determine a mapping area, the first point being the connection point between the first end and the catheter body; the range of the mapping area is determined by the first point, the length of the first end, and the degree of bending of the first end; The first end also includes a pressure sensor, and the first end includes a flexible section and a rigid section, the pressure sensor and at least two of the electrodes are disposed in the rigid section, and the remaining electrodes in the electrode group are disposed in the flexible section.

2. The ablation system according to claim 1, characterized in that, It also includes an adapter box, which is connected to the ablation device, the three-dimensional cardiac electrophysiological mapping system, the ablation catheter, and the back electrode patch, respectively; The adapter box is used to select the radiofrequency ablation pathway or pulse ablation pathway between the ablation device and the ablation catheter, transmit the data acquired by the ablation catheter during the operation to the three-dimensional cardiac electrophysiological mapping system, and construct the loop between the ablation catheter and the back electrode patch in the unipolar mode.

3. The ablation system according to claim 1, characterized in that, The control signal also includes a third sub-control signal, which is used to determine the number and position of the electrodes used for ablation in the electrode group.

4. The ablation system according to claim 1, characterized in that, When the first sub-control signal controls the electrodes in the electrode group to ablate in unipolar mode, the ablation device sets the second sub-control signal to perform point ablation on the target tissue.

5. The ablation system according to claim 1, characterized in that, When the first sub-control signal controls the electrodes in the electrode group to ablate in bipolar mode, the ablation device sets the second sub-control signal to perform linear ablation on the target tissue.

6. The ablation system according to claim 1, characterized in that, The number of electrode groups is between 10 and 20, and each electrode group includes a head electrode and several ring electrodes. The head electrode is located at the distal end of the first end, and the several ring electrodes are arranged along the direction from the distal end of the first end to the proximal end of the first end. The pressure sensor is used to transmit pressure data between the first end and the target tissue to the three-dimensional cardiac electrophysiological mapping system in real time, so that the three-dimensional cardiac electrophysiological mapping system can determine the contact status of the first end. The width of the head electrode ranges from 1.5mm to 5mm, the width of each ring electrode ranges from 0.3mm to 3mm, and the diameter of each electrode in the electrode group ranges from 2mm to 4mm. Except for the spacing between two electrodes adjacent to the pressure sensor, the spacing between two adjacent electrodes ranges from 1mm to 5mm, and the spacing between two electrodes adjacent to the pressure sensor is determined by the size of the pressure sensor.

7. The ablation system according to claim 6, characterized in that, At least one ring electrode is disposed between the pressure sensor and the head electrode.

8. The ablation system according to claim 6, characterized in that, Each electrode in the electrode group has an impedance detection function and is used to transmit the detected impedance data to the ablation device, so that the three-dimensional cardiac electrophysiological mapping system determines whether each electrode is effectively attached to the target tissue according to the preset pressure range and the ablation device according to the preset impedance range. The three-dimensional cardiac electrophysiological mapping system is also used to determine whether the target tissue is abnormal myocardial tissue based on the data obtained from the first end mapping. During ablation, the ablation device defaults to selecting the electrode that is in an effective contact state and is in contact with the electrode marked as abnormal myocardial tissue for ablation.

9. The ablation system according to claim 6, characterized in that, The head electrode has a protrusion at one end near the pressure sensor, and an insulating sleeve is provided between the protrusion and the pressure sensor to achieve electrical insulation between the pressure sensor and the protrusion.

10. The ablation system according to claim 6, characterized in that, The rigid section also includes a protective sleeve, which is arranged at least around the pressure sensor so that the pressure sensor is located inside the protective sleeve, and the ring electrodes on the rigid section are all arranged outside the protective sleeve.

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