CN121176996A - Ablation system - Google Patents

Abstract

An ablation system has been disclosed. The system includes a tubular ablation catheter and an ablation device. The catheter includes a distal end for abutting the target tissue, a proximal end for connecting to the ablation device, and a catheter body located between the distal and proximal ends. The ablation device transmits radiofrequency/pulsed energy to the ablation catheter to ablate the target tissue. An electrode array at the distal end acquires electrocardiogram (ECG) signals from the target tissue and transmits these signals to a three-dimensional cardiac electrophysiological mapping system for cardiac modeling and mapping. Each electrode has the capability to acquire ECG signals and ablate the target tissue. The electrode array receives control signals from the ablation device and determines whether the electrodes operate in unipolar/bipolar mode and whether point-like/linear ablation is achieved based on these signals. This system integrates mapping and ablation functions in a single catheter, achieving "dual-purpose use," and supports flexible switching between various ablation methods/shapes/energy levels, demonstrating strong versatility.

Description

Ablation system

Technical Field

The application relates to the technical field of cardiac ablation, in particular to an ablation system.

Background

Cardiac ablation is a minimally invasive interventional procedure commonly used for treating atrial or ventricular arrhythmias, and is widely applied to treatment of atrial fibrillation, ventricular tachycardia and other diseases. The basic principle is that radio frequency energy or other forms of energy are released through an ablation catheter to ablate abnormal conduction paths or ectopic pacing points in the heart, so that the conduction of abnormal electric signals is blocked. Clinically, ablation modes mainly include punctate ablation, which is suitable for the treatment of local abnormal foci, and linear ablation, which is commonly used to construct conduction block lines to prevent recurrence of arrhythmia.

However, in the actual operation process, most of the conventional punctiform or linear ablation catheters only have an ablation function, doctors also need to complete three-dimensional heart modeling and electrophysiological mapping by matching with a special mapping catheter, and then the ablation catheter is replaced to perform an ablation operation on target tissues. The catheter replacement process not only increases operation steps and operation time, but also can bring complications such as thrombosis, endocardial injury and the like, and has certain potential safety hazard. In addition, most of the existing ablation catheters are in a point-by-point ablation mode, so that the efficiency is low during linear ablation, and the treatment requirement of complex arrhythmia is difficult to meet. Therefore, the existing ablation system still has the defects in terms of functional integration and clinical application efficiency, and needs to be further improved.

Disclosure of Invention

In view of the above, the application discloses an ablation system, which organically combines an ablation catheter, an ablation instrument and a three-dimensional cardiac electrophysiology mapping system together to integrate mapping and ablation functions in a single ablation catheter, supports flexible switching of radio frequency/pulse dual-energy, monopolar/bipolar mode and punctiform/linear ablation, and remarkably improves the universality and efficiency of clinical application.

The ablation system comprises an ablation catheter and an ablation instrument, wherein the ablation catheter comprises a first end part for being abutted against target tissue to be ablated, a second end part for being connected with the ablation instrument and a catheter main body positioned between the first end part and the second end part, and the ablation catheter is tubular; the ablation instrument is configured to transmit radio frequency energy to the ablation catheter to cause the ablation catheter to perform radio frequency ablation on target tissue, or the ablation instrument is configured to transmit pulse energy to the ablation catheter to cause the ablation catheter to perform pulse ablation on the target tissue, the first end comprises an electrode group, the number of electrodes in the electrode group is at least 10, the electrode group is configured to acquire an electrocardiosignal of a space where the target tissue is located and transmit the electrocardiosignal to the three-dimensional cardiac electrophysiology mapping system, so that the three-dimensional cardiac electrophysiology mapping system realizes modeling and mapping of the heart based on the electrocardiosignal, the electrode group is further configured to receive a control signal from the ablation instrument and perform ablation on the target tissue by using radio frequency energy or pulse energy according to the control signal, each electrode in the electrode group has the capability of acquiring the electrocardiosignal and performing ablation on the target tissue, wherein the control signal comprises a first sub-control signal and a second sub-control signal, the electrodes in the first sub-control signal are used for controlling the electrodes in the electrode group to ablate the target tissue in a monopolar mode or a bipolar mode, the electrodes in the electrode group are used for outputting positive electrode signals and the selected electrode signals, the electrode group is used for the positive electrode group and the electrode group is used for the target tissue, and the second electrode group is used for the selected electrode in a linear mode, at least one of the electrode group is used for the electrode outputting the selected electrode in the electrode group is used for the target tissue, the ablation system further comprises a bending control handle arranged between the second end part and the ablation instrument, the first end part is an adjustable bending section, the first end part swings around a first point under the control of the bending control handle to determine a mapping area, the first point is a connection point of the first end part and the catheter main body, the range of the mapping area is determined by the first point, the length of the first end part and the bending degree of the first end part, the first end part further comprises a pressure sensor, the first end part comprises a flexible section and a rigid section, the pressure sensor and at least two electrodes are arranged on the rigid section, and the rest electrodes in the electrode group are arranged on the flexible section.

Optionally, the ablation system further comprises an adapter box, wherein the adapter box is respectively connected with the ablation instrument, the three-dimensional heart electrophysiology mapping system, the ablation catheter and the back electrode patch, and is used for gating a radio-frequency ablation path or a pulse ablation path between the ablation instrument and the ablation catheter, transmitting data acquired by the ablation catheter in a surgical process to the three-dimensional heart electrophysiology mapping system and constructing a loop between the ablation catheter and the back electrode patch in a monopolar mode.

Optionally, the control signals further comprise a third sub-control signal for determining the number and position of electrodes in the electrode set for ablation.

Optionally, when the first sub-control signal controls electrodes of the electrode set to ablate in a monopolar mode, the ablator sets the second sub-control signal to spot ablate the target tissue.

Optionally, the ablator sets the second sub-control signal to linearly ablate the target tissue when the first sub-control signal controls the electrodes of the electrode set to ablate in bipolar mode.

The three-dimensional cardiac electrophysiology mapping system comprises a first end, a first electrode group, a pressure sensor, a three-dimensional cardiac electrophysiology mapping system and a pressure sensor, wherein the number of the electrode groups is 10-20, the electrode groups comprise a head electrode and a plurality of ring electrodes, the head electrode is arranged at the distal end of the first end, the plurality of 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 for transmitting pressure data between the first end and target tissues to the three-dimensional cardiac electrophysiology mapping system in real time so that the three-dimensional cardiac electrophysiology mapping system can determine the leaning state of the first end, the width of each head electrode ranges from 1.5mm to 5mm, the width of each ring electrode ranges from 0.3mm to 3mm, the diameter of each electrode in the electrode groups ranges from 2mm to 4mm, the distance between two adjacent electrodes is 1mm to 5mm except the distance between the two electrodes adjacent to the pressure sensor, and the distance between the two electrodes adjacent to the pressure sensor is determined by the size of the pressure sensor.

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

Optionally, each electrode in the electrode group has an impedance detection function and is used for transmitting detected impedance data to an ablation instrument so that the three-dimensional cardiac electrophysiology mapping system can determine whether each electrode is effectively abutted against the target tissue according to a preset pressure range and the ablation instrument and further determine whether the target tissue is abnormal myocardial tissue according to data obtained by mapping the first end part, and when ablation is performed, the ablation instrument defaults to select the electrode which is in an effective abutted state and is abutted against the abnormal myocardial tissue.

Optionally, the end of the head electrode adjacent to the pressure sensor has a protrusion, and an insulating sleeve is provided between the protrusion and the pressure sensor to electrically insulate the pressure sensor from the protrusion.

Optionally, the rigid segment further comprises a protective sheath disposed at least around the pressure sensor such that the pressure sensor is located inside the protective sheath and the ring electrodes on the rigid segment are all disposed outside the protective sheath.

In summary, the ablation system disclosed by the application has at least the following beneficial effects:

(1) The catheter is optimized in the aspects of electrode number, distal structure, pressure sensor configuration and the like, so that the catheter not only can collect the intracardiac signals efficiently and transmit the intracardiac signals to a three-dimensional mapping system to complete modeling and mapping, but also can perform ablation operation on the same catheter. Unlike the prior art that the ablation catheter can be mapped but has low efficiency, the application realizes the mapping efficiency close to that of the special mapping catheter through the synergistic effect of the technical characteristics, thereby really achieving the dual-purpose of one tube. Therefore, the complex process that the catheter must be repeatedly replaced in the mapping and ablation stage in the traditional technology is avoided, the operation time is obviously shortened, the infection and operation risk caused by replacing the catheter are reduced, and a doctor can clinically complete mapping and ablation through one catheter at the same time, so that the operation convenience and the overall treatment effect are greatly improved.

(2) The ablation instrument can output radio frequency energy and pulse energy, and the ablation catheter can ablate target tissues by using the energy. Therefore, the ablation system can simultaneously meet the clinical requirements of radio frequency ablation and pulse thermal ablation so as to adapt to different focuses and different patient conditions.

(3) The ablation system can be switched between a monopolar mode and a bipolar mode by the first sub-control signal and can be selected between punctiform ablation and linear ablation by the second sub-control signal, and the ablation instrument can also select a corresponding optimal ablation shape by default according to a determined ablation mode (monopolar or bipolar). Therefore, a doctor can flexibly adjust an ablation strategy according to the arrhythmia type, and the continuity and thoroughness of the ablation range are improved.

(4) The electrode group also has an impedance detection function, and the distal end of the ablation catheter can be provided with a pressure sensor which respectively transmits data to an ablation instrument and a mapping system for judging the leaning state. Therefore, the ineffective ablation caused by insufficient abutment or the heart perforation caused by excessive abutment in the energy output process can be solved, and the operation safety and the treatment effect are improved.

(5) The adapter box disclosed by the application can realize unified signal and energy management among all components of the system. Through the arrangement of the switching box, on one hand, a radio frequency ablation passage or a pulse ablation passage between an ablation instrument and an ablation catheter can be flexibly gated, so that the same catheter can be switched to different ablation energy types according to requirements, thereby improving the diversity and adaptability of the ablation mode, and on the other hand, the switching box can transmit signals to a three-dimensional heart electrophysiology mapping system when the ablation catheter collects the signals, and is used for modeling and mapping, thereby maintaining the dual functions of the catheter in the operation process. In addition, the transfer box can automatically establish a loop between the ablation catheter and the back electrode patch in a monopolar mode, so that a doctor is prevented from carrying out complex external connection operation in operation. In summary, the introduction of the adapter box not only simplifies the connection relation among the catheter, the ablation instrument and the three-dimensional system, improves the overall operation convenience and stability of the system, but also further enhances the application capability of the catheter in various clinical situations.

(6) The one end that the head electrode is close to pressure sensor is provided with the protruding portion to increase insulating sleeve between protruding portion and pressure sensor, make between pressure sensor and the protruding portion realize electric insulation, thereby effectively avoid causing puncture or damage to pressure sensor at the too big electric current of electrode during operation, guarantee its long-term steady operation. Meanwhile, a protective sleeve is further arranged in the rigid section and at least surrounds the pressure sensor, so that the pressure sensor is located on the inner side of the protective sleeve, on one hand, the pressure sensor is prevented from being in direct contact with myocardial tissue, signal interference and mechanical abrasion are avoided, and on the other hand, additional rigid support is provided for the pressure sensor and the area where the pressure sensor is located, so that the positioning and supporting functions of the rigid section are better realized at the distal end of the catheter. Through the dual protection design of insulating sleeve and protective sheath, pressure sensor not only possesses electrical safety and stability, still possesses the protection nature on the machinery and the structural reliability to show the durability and the clinical applicability that have promoted whole pipe.

Drawings

The drawings that accompany the description can be briefly described as follows.

Fig. 1 shows a structural example diagram of an ablation catheter provided in an embodiment of the present application.

Fig. 2 illustrates a method of using an ablation system according to an embodiment of the present application.

Fig. 3 shows a structural example diagram of another ablation catheter provided by an embodiment of the present application.

Fig. 4 shows a unipolar punctiform ablation effect diagram of an ablation catheter according to an embodiment of the present application.

Fig. 5 shows a bipolar punctiform ablation effect diagram of an ablation catheter according to an embodiment of the present application.

Fig. 6 shows a unipolar linear ablation effect graph of an ablation catheter under all electrode discharge conditions, as disclosed in an embodiment of the present application.

Fig. 7 shows a bipolar linear ablation effect graph of an ablation catheter in a full electrode discharge situation, as disclosed in an embodiment of the present application.

Fig. 8 shows a unipolar linear ablation effect graph of an ablation catheter in a partial electrode discharge situation, as disclosed in an embodiment of the present application.

Fig. 9 shows a bipolar linear ablation effect diagram of an ablation catheter in a partial electrode discharge situation, according to an embodiment of the present application.

Fig. 10 shows an ablation effect diagram of an ablation catheter on potatoes according to an embodiment of the present application.

Fig. 11 shows an ablation effect of another ablation catheter disclosed in an embodiment of the application on potatoes.

Fig. 12 shows an ablation effect of yet another ablation catheter disclosed in an embodiment of the application on potatoes.

Fig. 13 shows an ablation catheter disclosed in an embodiment of the present application for ablating an isolated heart of a dead animal.

Fig. 14 illustrates an ablation effect of another disclosed ablation catheter on the isolated heart of a dead animal.

Fig. 15 shows a physical diagram of an ablation catheter provided by an embodiment of the present application.

Fig. 16 shows a structural example diagram (without insulating sheath) of a head electrode of an ablation catheter according to an embodiment of the present application.

Fig. 17 shows an exemplary diagram of the structure of a head electrode (with an insulating sheath) of another ablation catheter provided by an embodiment of the application.

Fig. 18 illustrates an enlarged view of a first end of an ablation catheter provided by an embodiment of the application.

Detailed Description

In order to more clearly describe the technical solution of the embodiment of the present application, a specific embodiment of the present application will be described below with reference to the accompanying drawings. The drawings described below are only examples of the present application, and it is apparent to those skilled in the art that other drawings and other embodiments can be made from these drawings without departing from the spirit of the present application.

For the sake of simplicity of the drawing, only the parts relevant to the corresponding embodiments are schematically represented in the figures, which do not represent their actual structure as a product. In addition, in order to simplify the drawing for understanding, components having the same structure or function are shown only in part schematically in some drawings, and more or fewer components having the same structure or function may actually be present.

In the present application, ordinal terms such as "first," "second," and the like, are used solely to distinguish between the associated objects and are not to be construed as indicating or implying a relative importance or order between the associated objects unless otherwise expressly specified and defined, nor is it intended to represent the number of associated objects. "plurality" includes two or more, and the like. "/" is used to describe a relationship between associated objects, which represents an or relationship between associated objects. "and/or" is used to describe a relationship between associated objects that includes any combination of relationships between associated objects, e.g., "a and/or b" includes "a alone", "b alone", or "a and b". "one or more" or "at least one" of the plurality of objects refers to any object or any combination of the plurality of objects, such as "one or more of a1, a2, a3" or "at least one of a1, a2, a3" including "a1 alone", "a2 alone", "a 3 alone", "a1 and a2", "a1 and a3", "a2 and a3", or "a1, a2 and a3".

Arrhythmia is a common abnormal disease of heart electrical activity, and is essentially an abnormal electrical activity starting point of myocardial tissue or abnormal electrical signal conduction paths in the heart, so that the heart rhythm is irregular, and palpitation, heart function decline and sudden death can be caused. Currently, radiofrequency ablation (Radiofrequency Ablation, RFA) is one of the important means of clinical treatment of cardiac arrhythmias. The basic principle of radio frequency ablation is that an electrode at the far end of the ablation catheter is sent into a heart cavity to be clung to the surface of target myocardial tissue through a controllable ablation catheter, and then radio frequency energy is released to cause coagulation necrosis of the tissue at the position, so that abnormal electrical conduction paths are blocked or an ectopic pacing point is ablated. In this way, the physician can reestablish a normal cardiac conduction path, achieving a therapeutic effect.

In conventional radiofrequency ablation procedures, common catheter forms are mainly punctiform ablation catheters and linear ablation catheters. The dot-shaped ablation catheter is structurally characterized in that only one small electrode is arranged at the distal end of the catheter, a doctor operates the catheter to tightly attach the electrode to the surface of a cardiac muscle, and a local small dot-shaped focus can be formed by releasing energy each time. However, many lesions in the clinic are not single punctate areas, but rather require the formation of a complete isolation line (e.g., around the pulmonary vein opening, an annular ablation line is constructed to isolate the trigger source of atrial fibrillation). In this case, the physician needs to repeatedly move the catheter electrode by releasing energy at a certain point to form a punctiform focus, then moving the catheter to an adjacent position to release energy again, forming a point again, accumulating point by point, and finally connecting a plurality of points end to form a continuous linear ablation blocking band. The mode is characterized by point-by-point line drawing, low efficiency and strong operation dependence on doctors.

The design idea of the linear ablation catheter is that a plurality of electrodes are arranged at the distal end of the catheter and are arranged in a straight line or an arc shape so as to form a linear focus at one time. However, in traditional clinical applications, such catheters still typically employ a pattern of sequential energy release electrode-by-electrode. That is, although the catheter itself has a plurality of electrodes, the physician often operates the catheter by letting the first electrode release energy, changing the catheter to the second electrode, changing the catheter to the third electrode, completing the catheter one by one, and finally connecting the punctiform lesions together. In other words, even if a "linear ablation catheter" is used, its practical effect is still similar to that of a punctiform catheter, but the number of electrodes is increased, but the construction of the entire ablation line cannot be completed at one time. Thus, radio frequency ablation in conventional modes, whether punctiform or linear, still requires the physician to perform an isolation line just like "stippling" by "multiple, point-by-point energy release.

This traditional "point-by-point" approach suffers from significant drawbacks. Firstly, the operation efficiency is low, doctors need to repeatedly operate the catheter, each point needs to complete the processes of leaning, energy release and movement, then the operation is performed, and the whole operation process consumes longer time. Secondly, the continuity is poor, since the procedure is entirely dependent on manual control, if there is a deviation in the catheter's position of abutment, or if the point-to-point spacing is too great, it may result in "gaps" in the ablation line, forming so-called "conduction gaps". These gaps can become "weeping fish" of the electrical signal, resulting in recurrence of the arrhythmia following ablation. Again, the operation difficulty is high, and a doctor has to repeatedly and finely operate the catheter within a limited time, so that not only is the sufficient coverage of an ablation point ensured, but also myocardial damage caused by excessive ablation is avoided, and high requirements are put on the experience and operation skills of the doctor.

Furthermore, in the prior art, a typical cardiac rf ablation procedure generally requires the sequential use of two different types of catheters. At the beginning of the operation, a doctor firstly inserts a special mapping catheter into the heart chamber, the catheter is usually provided with a plurality of electrodes, which can reach tens of electrodes, and electrophysiological signals at different positions in the heart chamber can be acquired in real time and transmitted to a three-dimensional electrophysiological mapping system. Through the multipoint sampling of the mapping catheter, a doctor can rapidly and accurately draw the three-dimensional electro-anatomical map of the heart chamber and the distribution situation of abnormal electric activities. After the mapping work is completed and a complete electrophysiological map is obtained, the doctor pulls out the mapping catheter and then replaces the mapping catheter with a special ablation catheter. Although the ablation catheter has certain signal acquisition capability, the main function of the ablation catheter is to release radio frequency energy to target tissues to complete the ablation operation, so that the number and the spatial distribution of the electrodes are far less than those of the mapping catheter, and the number of the electrodes is about 4-8. At this stage, the ablation catheter is connected with the ablation instrument to perform ablation on one hand, and can still keep data interaction with the three-dimensional mapping system on the other hand, so as to be used for positioning and effect verification in the operation process. Therefore, in the prior art, the whole operation flow needs to respectively depend on two different catheters, namely, three-dimensional mapping is firstly performed by using a mapping catheter, then ablation is performed by using an ablation catheter, and all operations cannot be completed by using a single catheter.

Wherein the catheter also needs to be connected to both the three-dimensional mapping system and the ablation instrument at the same time during the ablation phase, and not just the ablation instrument, because the two types of devices are functionally complementary rather than in a surrogate relationship. The ablation instrument outputs radio frequency energy to the catheter, so that focus points are formed on cardiac muscle, and the treatment function is realized. However, the ablation instrument itself does not have three-dimensional positioning and electrical signal acquisition capabilities, and cannot inform a doctor of the precise position of the catheter in the heart chamber, and cannot record the distribution of energy release points. If the catheter is only connected with an ablation instrument during ablation, a doctor can release energy, but can not see the position distribution of ablation points on the three-dimensional reconstructed anatomical model in real time, and can not judge the ablation effect by combining local electric signal changes. In contrast, the three-dimensional mapping system can continuously track the spatial position of the catheter, collect electrophysiological signals, and mark the point position corresponding to each ablation in the three-dimensional heart cavity model in real time, so that a doctor can have full-course visual navigation and curative effect feedback in the ablation process. Therefore, only under the condition that the catheter is simultaneously connected with the three-dimensional mapping system and the ablation instrument, the combination of energy output, real-time positioning and signal acquisition can be realized, and the accuracy and safety of operation are ensured. Therefore, during the ablation process, the prior art ablation catheter not only delivers rf energy, but its electrodes still collect electrical signals within the heart chamber and transmit these signals to the three-dimensional mapping system.

However, although the ablation catheter in the prior art can perform mapping and ablation operations at the same time to a certain extent in the ablation process, the number of electrodes is limited, the mapping points are sparse, the spatial resolution and the signal coverage capability are far less than those of a special mapping catheter, so that the mapping efficiency is extremely low, and the requirement of clinic on three-dimensional mapping cannot be met at all. On the one hand, the catheter collects mapping data point by point in the heart cavity, the process is tedious and time-consuming, long operation time is often required if the mapping work is completed by only relying on the catheter, and on the other hand, the obtained mapping result is unsatisfactory in terms of accuracy and integrity due to the limited number of collection points and insufficient space coverage.

In order to solve the problems of low efficiency, poor continuity and high operation difficulty in the prior art, the application has the core concept that the multifunctional integration and the operation flexibility are realized by innovatively designing the structure and the energy control mode of the catheter. On one hand, the catheter adopts a multi-electrode mapping and ablation integrated structural design, so that doctors can complete multi-electrode electrophysiology mapping, three-dimensional anatomical modeling and ablation operation on the same instrument, efficiency loss caused by frequent replacement of the instrument is avoided, and abnormal myocardial areas can be determined more accurately. On the other hand, the catheter supports flexible selection of punctiform or linear ablation forms and can be switched between monopolar and bipolar modes, so that requirements of different anatomical parts and different ablation strategies are met. Meanwhile, the ablation energy can be selected between pulse electric field ablation (PFA) and radio frequency ablation (RF) so as to adapt to the tissue characteristics and clinical operation modes of different parts of the heart, and the adaptability and the overall curative effect of the operation are greatly improved.

The following description is made with reference to the accompanying drawings.

Referring to fig. 1, a schematic diagram of an ablation catheter according to an embodiment of the present application is shown. As shown in fig. 1, the ablation system includes an ablation catheter 100 and an ablation instrument (not shown in the drawing), the ablation catheter 100 including a first end 101 (which may also be referred to as a distal end of the ablation catheter) for abutting against a target tissue to be ablated, a second end 102 (which may also be referred to as a proximal end of the ablation catheter) for connection with the ablation instrument, and a catheter body 103 located between the first end 101 and the second end 102, the ablation catheter 100 being tubular. Also included between the second end 102 and the ablation instrument is a handle 200. During the procedure, the physician may manipulate handle 200 to achieve precise control over ablation catheter 100. The first end 101 comprises an electrode set, the number of the electrodes in the electrode set is at least 10, the electrode set is configured to acquire electrocardiosignals of a space where target tissues are located and transmit the electrocardiosignals to a three-dimensional cardiac electrophysiology mapping system, so that the three-dimensional cardiac electrophysiology mapping system realizes modeling and mapping of hearts based on the electrocardiosignals, the electrode set is further configured to receive a control signal from an ablation instrument and ablate the target tissues by utilizing radio frequency energy or pulse energy according to the control signal, and each electrode in the electrode set has the capability of acquiring the electrocardiosignals and ablating the target tissues.

The ablation catheter is of a tubular structure, so that the ablation catheter can simultaneously contain a signal transmission wire and an energy transmission channel in a limited space, and therefore, the catheter can realize high-efficiency acquisition of electrocardiosignals and stable transmission of ablation energy. Compared with catheters with other shapes, the tubular structure has flexibility and operability, can flexibly operate in blood vessels and heart cavities, better clings to target tissues, and is beneficial to synchronous ablation and mapping. In addition, the first end is provided with at least 10 electrodes, and experimental results show that when the number of the electrodes is less than 10, the acquired electrocardiosignals are difficult to meet the modeling and mapping requirements in terms of space coverage rate and accuracy, and by arranging at least 10 electrodes, not only can sufficient signal density be ensured, the modeling and mapping accuracy of the three-dimensional cardiac electrophysiology mapping system is improved, but also each electrode can have the functions of ablation and mapping.

Referring to fig. 3, a schematic diagram of another ablation catheter according to an embodiment of the application is shown. As shown in FIG. 3, the ablation system further comprises a bending control handle 210 arranged between the second end 102 and the ablation instrument, wherein the first end 101 is an adjustable bending section, 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, the first point X is a connection point between the first end 101 and the catheter body 103, and the range of the mapping area S is determined by the first point X, the length of the first end 101 and the bending degree of the first end 101 to form a mapping area similar to a fan shape. A and B in fig. 3 are two bending directions of the first end, respectively, and a doctor can control the bending in two directions by controlling the bending control handle 210 during use.

The bending control handle 210 in the application can precisely drive the bending of the first end part 101 through a mechanical transmission structure, thereby realizing multidirectional bending control of the distal end of the catheter. In the operation process, the doctor can flexibly adjust the bending angle and direction of the first end 101 by only rotating or pushing the bending control handle 210, so that the doctor can realize wide-range swing and positioning in the heart cavity or the blood vessel. Unlike conventional point-like or linear ablation catheters, which generally require moving the catheter point by point and drawing the ablation line point by point, the present application drives the first end 101 to swing around the first point X by the bending control handle 210, so that one target area S can be covered at a time, and the efficiency of mapping and ablation is significantly improved. In clinical application, the doctor can change the catheter position according to actual conditions to confirm a plurality of target areas S, form continuous ablation kitchen or ablation line fast, reduce the operation time. Meanwhile, the bending control handle 210 is matched with the adjustable bending section of the first end portion 101, so that the distal end of the catheter has stronger flexibility and operability, and high-precision mapping and ablation operations can be completed in a complex heart chamber structure.

In other embodiments of the present application, the bend control handle 210 is an integrated mechanical bend control and locking structure that enables fine manipulation of the first end 101 in two dimensions (up/down/side to side) or quasi-three dimensions. The bend control handle 210 includes a slider or thumb wheel for axial push-pull, a cross rocker/knob for direction switching, a locking member for angle retention (e.g., a ratchet/toggle/ball spring mechanism), and an angle scale display and zero reset mechanism. The physician drives the internal traction wires (nickel titanium memory alloy wires may also be used) in the guide wheels/runners in the handle by rotating the thumbwheel or pushing the slider, with the traction wires anchored at their front ends to different quadrants (typically 2 opposed or 4 in a cross arrangement) of the first end 101 and connected at their rear ends to the drive drum. The forward and reverse rotation of the drum wheel respectively generates a pulling force in a corresponding direction, so that the adjustable bending section can be controllably bent around the first point X. To avoid rebound and hysteresis, the bend control handle 210 is provided with a low friction bushing and a pre-tightening spring on the transmission path, and cooperates with a mechanical stop ring to control the maximum bending angle, thereby preventing the traction wire and the catheter wall from being damaged by overbending. The locking piece can be locked instantly after the desired angle is reached, the bending angle is ensured to be stable and not to drift, and when the locking piece is required to be released, a doctor can reset to the zero smoothly by pulling the unlocking piece. With the above structure, the first end portion 101 can achieve a small radius, repeatable quantitative bending, and torque is efficiently transmitted along the braided/wound reinforcement layer of the catheter body 103, with a sensitive and stable distal end response.

The material of the adjustable bending section can be, for example, a multi-cavity (multi-lumen) polymer tube body (such as Pebax/PU) embedded with a stainless steel woven mesh or flat wire winding layer so as to achieve both torsion resistance and bending resistance, wherein each cavity respectively accommodates a multi-electrode wire, an energy transmission conductor, a perfusion channel and a traction steel wire channel. The traction steel wires are anchored in a zoned mode in a ring or cross mode at the far end, the radian is uniform and the curvature is predictable during bending, and the near end realizes compound bending through a drum differential structure, so that a doctor can complete high coverage scanning and leaning under the condition of not repeatedly drawing and inserting a catheter. Even in a state where the first end portion 101 is in continuous contact with the target tissue, the lock angle can be stably maintained, and displacement due to the cardiac cycle and the shear of the blood flow can be reduced.

Based on the bending control capability, the first end 101 swings in a fan shape or space around the first point X under the driving of the bending control handle 210, so that one target area S can be covered at a time. The extent of the mapping region S is determined by the location of the first point X, the effective length of the first end 101, and the achievable bend angle (including the radius of curvature). Unlike the conventional stippling operation of "point-by-point movement, point-by-point energy release", the embodiment completes electrophysiological acquisition and ablation marking of multiple points in the region S in a short time by means of "fixed angle-sweeping", and realizes a "point-to-plane" working unit. The doctor can change the overall azimuth or the pushing/withdrawing position of the catheter according to the heart cavity dissection and focus distribution as required, and a plurality of mapping areas S1 and S2 are determined in sequence, so that the target heart cavity is covered rapidly in a splicing mode. The flow obviously shortens the positioning and confirming time, reduces the complication risk caused by repeated plugging and pulling and large displacement, and simultaneously provides a continuous and dense reference path for subsequent linear or annular ablation.

The large-range swingable characteristic of the first end 101 is matched with the high-density arrangement of the electrode groups (the number of the electrodes is more than or equal to 10), so that the edge mapping and the ablation are enabled to become an operable normal path, namely when abnormal electric activity is detected at any point in the area S, the system can directly call the corresponding electrode (or the electrode group) to implement punctiform/linear ablation under the condition that the current bending angle is kept unchanged or fine-tuned, and the instrument and the gesture do not need to be switched after the full-cavity mapping is completed. Because the torque transmission is stable, the angle is lockable, the curvature is repeatable, and doctors can complete the closed loop of 'confirmation-treatment-recheck' under the same geometric configuration, thereby improving the instantaneity and consistency.

In this way, the bend control handle 210 achieves fine bend control of the first end 101 through predictable traction drive, low friction steering, angle locking and limit protection, which in cooperation with the multi-lumen reinforced tubular catheter body 103, dense electrode set, enables a "define mapping region S with swing, to lock to ensure repeatability, to promote real-time in situ ablation" mode of operation. Compared with the traditional point/linear catheter which can only move point by point, the structure has obvious advantages in the aspects of coverage efficiency, positioning precision, control stability and clinical safety.

Referring to fig. 15, a physical diagram of an ablation catheter according to an embodiment of the present application is shown. On the basis that the first end part is a controllable bending section, the first end part further comprises a pressure sensor, the first end part comprises a flexible section and a rigid section, the pressure sensor and at least two electrodes are arranged on the rigid section, and the rest electrodes in the electrode group are arranged on the flexible section. That is, the first end portion may be divided into two portions, a flexible segment and a rigid segment, depending on the stiffness. Wherein the pressure sensor and at least two electrodes are arranged on the rigid section, and the remaining electrodes are arranged on the flexible section. In fig. 15, there are 4 electrodes and pressure sensors on the rigid section and 6 electrodes on the flexible section. However, the application is not limited to the ratio of the electrodes on both. For example, 3 electrodes are provided on the rigid segment and 7 electrodes are provided on the flexible segment, and for example, 5 electrodes are provided on the rigid segment and 5 electrodes are provided on the flexible segment. In addition, in the application, the working efficiency of the ablation catheter can be improved by arranging more electrodes on the flexible section. As can be seen from fig. 15, there are many spare areas on the flexible segment, which can be used to set a certain number of electrodes, and the specific set number can be set according to the user's needs, which is not limited by the present application.

The application realizes the dual-purpose of one tube by combining the three technical characteristics disclosed above, and is characterized in that (1) the number of the electrodes in the electrode group is more than 10, (2) the distal end (namely the first end) of the catheter is a controllable bending section and is particularly divided into a flexible section and a rigid section, the pressure sensor is arranged in the rigid section, (3) a certain number of electrodes are arranged on the flexible section, if the number of the electrodes is required to be expanded, the corresponding number of ring electrodes can be directly added on the flexible section, and in addition, the electrode number ratio in the flexible section and the rigid section can be changed.

First, the number of electrodes in the electrode set is greater than 10, which is the basic condition for achieving efficient mapping. Compared with the ablation catheter in the prior art, which is generally provided with only a small number of electrodes (for example, 4 electrodes), the application greatly increases the number of the electrodes, so that a large number of intracardiac signals can be acquired simultaneously, and the spatial resolution and the signal coverage range are ensured to be close to those of a special mapping catheter. And secondly, the distal end of the catheter is a controllable bending section and is divided into a flexible section and a rigid section, and a pressure sensor is arranged in the rigid section. The design of the controllable bending section enables a doctor to flexibly control the head of the catheter, and conduct large-scale scanning in the heart cavity, so that the mapping efficiency is greatly improved, while the pressure sensor is arranged on the rigid section, can detect the leaning state in real time in the ablation or mapping process, avoids signal distortion or invalid ablation caused by poor leaning, and can detect instability caused by overlarge deformation if arranged on the flexible section. Finally, disposing electrodes on the flexible segment and allowing for further expansion of the number of electrodes, such as by increasing the ring electrodes or adjusting the electrode number ratio on the flexible segment to the rigid segment, can further increase the coverage density of the mapping points, enabling a sampling capability that is closer to that of a dedicated mapping catheter. Through the cooperative layout of the flexible section and the rigid section electrode, the breadth and the precision of mapping are ensured, and the stability and the safety of ablation operation are also considered.

Therefore, the catheter of the application does not simply carry some mapping functions on the ablation catheter, but achieves the mapping efficiency equivalent to that of a special mapping catheter on the whole by the sufficient number of electrodes, reasonable segmentation of a far-end structure and cooperation with a pressure sensor and the cooperative design of flexible and rigid segment electrodes, thereby truly having the practical value of dual-purpose one-tube. Compared with the prior art, the method has the advantages that the efficient mapping and effective ablation can be realized in the single catheter, the complicated process that the mapping catheter and the ablation catheter must be replaced in sequence in the traditional operation is avoided, and the fundamental defect that the existing ablation catheter can be mapped but has extremely low efficiency and cannot meet clinical requirements is overcome.

Moreover, each electrode in the electrode group has the capability of collecting electrocardiosignals and ablating target tissues at the same time, so that the practical range of mapping and ablation can be maximized, and the effect of mapping and ablation can be realized. When an abnormal electric signal or a focus part is found in the mapping process, the ablation treatment can be directly implemented without waiting for the completion of the whole mapping process, and compared with the traditional scheme that the mapping is firstly completed and then the ablation is independently carried out, the scheme has better instantaneity and pertinence, and can be immediately solved while the problem is found, so that the operation efficiency and the treatment effect are obviously improved.

After the ablation catheter collects the electrocardiosignals of the space where the target tissue is located, the electrocardiosignals are transmitted to the three-dimensional cardiac electrophysiology mapping system. The mapping system can combine the catheter position information and the electrocardiosignal to generate a three-dimensional electroanatomical model of the heart, and display the electric activity distribution situation on the model in real time, thereby helping doctors to intuitively judge the electrophysiological characteristics of different myocardial tissues and locating the myocardial region with abnormal conduction or pathogenicity reentry loops. The modeling and mapping mode effectively improves the identification precision of focus positions and provides reliable basis for subsequent ablation treatment.

In delivering ablation therapy, the ablation catheter may deliver radiofrequency energy or pulsed energy to the target tissue. Rf energy is used in situations where, for example, sustained scarring is required to achieve effective ablation and isolation of abnormal myocardial tissue, while pulsed energy is more suitable for applications where, for example, selective destruction of myocardial cells is required while reducing the risk of injury to adjacent tissue. Rf energy is suitable for forming persistent scars because its thermal effects by electrical current can cause stable and deep coagulative necrosis in myocardial tissue, thereby forming a continuous scar barrier that helps to block the conduction path of abnormal electrical signals. The pulse energy is to change the cell membrane permeability (electroporation effect) by means of a high-intensity electric pulse for a short time, thereby selectively destroying the myocardial cells without relying on significant thermal injury. Since this mechanism is less damaging to non-myocardial tissue (e.g., esophagus, phrenic nerve, or coronary artery), it is more suitable for use in situations where damage to peripherally sensitive structures is a concern. The ablation catheter can be selectively applied between two modes of radio frequency ablation and pulse ablation according to actual treatment requirements, so that the ablation catheter has strong universality and flexibility, and can cover wider clinical use scenes.

The ablator is configured to transmit radio frequency energy to the ablation catheter to cause the ablation catheter to perform radio frequency ablation on the target tissue, or the ablator is configured to transmit pulsed energy to the ablation catheter to cause the ablation catheter to perform pulsed ablation on the target tissue, and the control signals transmitted by the ablator to the ablation catheter further comprise a first sub-control signal for controlling the electrodes in the electrode set to ablate the target tissue in either a monopolar mode in which the electrodes selected for ablation in the electrode set each output a positive signal, or a bipolar mode in which the electrodes selected for ablation in the electrode set comprise at least one electrode outputting a positive signal and at least one electrode outputting a negative signal, and a second sub-control signal for controlling the electrodes in the electrode set to perform spot ablation or linear ablation on the target tissue.

The ablation instrument is designed to flexibly regulate and control the working mode of the ablation catheter under the operation of doctors so as to adapt to the clinical treatment requirements under different types of arrhythmia and different focus conditions. For example, the ablator can deliver different types of energy to the ablation catheter, on the one hand, continuous radiofrequency energy can be selectively delivered to cause the electrodes to perform conventional radiofrequency ablation on the target tissue, and on the other hand, pulsed energy can also be selectively delivered to achieve pulsed ablation to meet the safety treatment requirements of a portion of a particular lesion (e.g., adjacent a conductive bundle or vessel).

In some embodiments, the ablator is an integrated device that can select one of the output of radio frequency energy and pulsed energy. In other embodiments, the ablation device of the present application is a generic term for an ablation device that includes a radiofrequency device for outputting radiofrequency energy and a pulse ablation device for outputting pulse energy.

The control signal of the ablator further comprises a first sub-control signal and a second sub-control signal based on the energy transmission. The first sub-control signal is used to select the ablation mode as monopolar ablation or bipolar ablation. In the bipolar mode, at least one electrode in the electrode group is used as an anode, at least one electrode is used as a cathode, and a current path is directly closed between the electrodes, so that a relatively concentrated and controllable ablation area can be formed, and the electrode is more suitable for ablation of adjacent important anatomical structures. The second sub-control signal is then used to select the ablation mode as punctiform ablation or linear ablation. In punctiform ablation, the current is concentrated at a single electrode point, which is suitable for the accurate treatment of a focal lesion, while in linear ablation, a group of electrodes arranged along a certain direction can be selected at the same time, so that a continuous linear injury zone is formed on the surface of the cardiac muscle and used for blocking a macroreentrant passage.

It should be noted that punctiform ablation and linear ablation are significantly different and targeted at the application level. The punctiform ablation refers to the local position of target tissue, the single or a small number of electrodes output energy in a concentrated way, and a localized ablation focus is formed on the surface of the tissue or at a certain depth. The linear ablation is to form a continuous linear damage band on the surface of the cardiac muscle by a group of electrodes which are arranged along a specific direction and output energy at the same time, so as to construct an electric conduction blocking band which is commonly used for blocking a large-scale macro-reentry path or cutting off an abnormal circuit. Compared with punctiform ablation, linear ablation can complete electric conduction isolation of a larger area at one time, thereby reducing operation time and improving operation efficiency. Through flexible switching of the two modes, local accuracy and overall blocking can be considered on the style of an ablation stove, and the treatment effect and clinical adaptability of an ablation operation are remarkably improved.

Through the flexible combination of the energy types, the monopolar/bipolar modes and the punctiform/linear modes, the ablation instrument and the ablation catheter can provide 8 different ablation combination modes theoretically, so that the clinical adaptability of the system under different focus types and different anatomical areas is greatly improved, and a doctor can adjust an ablation strategy in real time according to the condition of a patient.

It should be emphasized that a core innovation of the present application is that the entire system is not only improved on a single component of the ablation catheter or ablation instrument, but that a high degree of fusion of energy control, polarity control and ablation mode control is achieved through the coordinated design between the ablation catheter and ablation instrument. The systematic design ensures that the ablation system can be deeply combined with the three-dimensional heart electrophysiology mapping system, and the effects of mapping and ablation at the same time and flexibly adjusting the treatment strategy are realized in the operation process. Therefore, the whole scheme provided by the application has stronger clinical universality, can meet the treatment requirements of complex and changeable arrhythmia, and remarkably improves the instantaneity, safety and effectiveness of the operation.

Referring to fig. 2, a method for using an ablation system according to an embodiment of the present application is shown. As shown in fig. 2, when performing an ablation operation, a doctor selects the type of ablation energy according to the operation requirement, and can select radio frequency energy or pulse energy, then further selects an ablation mode, namely monopolar ablation or bipolar ablation, and finally selects an ablation shape according to the focus characteristics, wherein the ablation shape can be punctiform ablation or linear ablation. Through the operation flow selected step by step, doctors can flexibly configure different ablation modes in the same system, and the omnibearing combination from energy type to action mode to oven shape is realized. The method not only improves the intuitiveness and controllability of operation, but also has high universality in clinical application, can cover various clinical situations from focal lesion treatment to large-scale electric conduction blocking and the like, and provides uniform platform support for different types of arrhythmia treatment.

The universality refers to that one catheter can adapt to clinical requirements and changeable focus conditions of different patients. In the prior art, doctors often need to select ablation catheters with different models or structures according to the lesion size, the position and the pathological characteristics of patients, which not only increases the complexity of preoperative preparation and instrument management, but also easily causes poor surgical effect and even failure due to improper catheter selection, thereby increasing clinical risks. The present application is based on the pain point to propose a new ablation system. As shown in fig. 2, 8 different ablation results can be theoretically achieved, which cover different ablation energies, different ablation modes and different ablation shapes, far exceeding the single output mode of the catheter in the prior art. By receiving external control signals, the catheter can flexibly switch the ablation mode and the ablation shape according to the needs, such as punctiform ablation, linear ablation or planar ablation, so as to cope with diversified treatment requirements in the same operation process. In addition, the ablation instrument can selectively transmit radio frequency energy or pulse energy to the catheter, so that the catheter can achieve more accurate and efficient treatment effects under different lesion types. Therefore, the technical scheme of the application not only reduces the burden of preparing various catheters for different operation situations by doctors, but also clinically and obviously improves the application range and the application efficiency of the ablation catheter, and ensures the consistency and the safety of the operation.

In some embodiments of the application, the ablator sets the second sub-control signal to spot ablate the target tissue when the first sub-control signal controls the electrodes in the electrode set to ablate in a monopolar mode, and in other embodiments of the application, the ablator sets the second sub-control signal to linearly ablate the target tissue when the first sub-control signal controls the electrodes in the electrode set to ablate in a bipolar mode. The punctiform ablation is preferably monopolar ablation, because the depth of an ablation focus formed by the monopolar ablation is deeper, the target tissue can be effectively penetrated, and meanwhile, the electric field form of the punctiform ablation has less influence on surrounding tissues, so that the stability and the safety of operation are improved. Whereas linear ablation may be either monopolar or bipolar, bipolar ablation is preferred because bipolar ablation produces less muscle stimulation, thereby alleviating the patient's pain during treatment. Although in many clinical scenarios monopolar punctiform ablations are widely used, in other cases monopolar linear ablations are equally interesting. For example, where a deeper and continuous ablation line is desired along a particular anatomical structure of the heart (e.g., the mitral isthmus, the tricuspid annulus, or the left atrial apex), monopolar linear ablation may provide a stronger tissue penetrating force, helping to achieve a more thorough electrical conduction block at these thick-walled or complex structural sites. In this mode, the electrode on the catheter selected as the positive electrode forms a plurality of independent loops with the back electrode of the body surface, so that a continuous linear ablation zone is realized by accumulating point by point. On the other hand, bipolar mode may also be used to achieve punctiform ablation in certain small areas of lesions where local precision treatment is required. For example, near the thin-walled region of the atrium or adjacent to important structures (e.g., ostia of pulmonary veins, near the atrioventricular node), a physician may wish to concentrate energy between adjacent electrodes of the catheter to reduce interference with distal tissue. At this time, at least one local loop is formed between the electrode outputting the positive electrode signal and the electrode outputting the negative electrode signal on the catheter, so that bipolar punctiform ablation is realized. The method can ensure the ablation effect, reduce the damage to non-target tissues and further improve the safety and controllability of operation.

Further, in some embodiments of the present application, the ablation device automatically corresponds and matches the ablation mode with the ablation shape according to a preset logic relationship, so as to simplify the operation of the doctor. For example, when the monopolar mode is selected, the ablation instrument automatically defaults to punctiform ablation, and when the bipolar mode is selected, the ablation instrument automatically defaults to linear ablation. The default matching not only reduces the steps of manual setting of doctors in the operation and improves the operation efficiency, but also can reduce the risk caused by manual selection errors in the urgent or complex operation process, thereby improving the overall treatment safety and consistency. Of course, in special clinical situations, such as the ones listed in the embodiments above, the physician may still manually modify the ablation shape according to actual needs in order to provide more flexible treatment for different lesion characteristics. Therefore, the design not only ensures the intellectualization and convenience of the system, but also reserves the flexibility of manual intervention, and can consider most common clinical scenes and personalized requirements.

In some embodiments of the application, the control signals further comprise a third sub-control signal for determining the number and position of electrodes in the electrode set for ablation. That is, during the procedure, the physician is free to select any electrode of the electrode set on the first end for ablation. The electrodes of this embodiment are discharged independently of each other, so that the electrode discharge can be selected according to actual needs. One or more discharge electrodes can be selected for discharge ablation, other electrodes are not discharged, and all the electrodes can be selected for discharge simultaneously. For example, referring to fig. 1, the physician may select electrode 1, electrode 3, electrode 5, electrode 7, and electrode 9 for an ablation procedure, while electrode 2, electrode 4, electrode 6, electrode 8, and electrode 10 are turned off. This is merely an example to illustrate that the choice of electrode may be freely set according to the needs of the physician.

In the prior art, when some ablation catheters are used for ablation, electrodes of the ablation catheters are often only conducted integrally and work simultaneously, and independent control capability of a single electrode is lacked. For example, some common monopolar ablation catheters have an integrated electrode structure, and when energy is released, all electrodes must be conducted simultaneously, so that fine local selection cannot be realized in the ablation process; for example, some multipolar ablation catheters, while having multiple electrodes, do not provide a controlled function, but are only triggered in groups and cannot be operated independently at the electrode level, and for example, some catheters of relatively advanced designs, while supporting multipolar ablation, generally employ fixed electrode combination schemes, still lack flexibility and are difficult to address complex arrhythmic lesions.

In contrast, the ablation catheter in the embodiment of the application can accurately manage each electrode on the first end through means of circuit control, matrix switch control or an integrated electrode selection module. After the doctor identifies the positions of the abnormal myocardial tissue and the normal myocardial tissue under the cooperation of the mapping electrodes, the doctor only selects the electrode positioned in the abnormal myocardial area to release energy, and closes the electrode positioned in the normal myocardial tissue. By the method, the focus area can be ablated pertinently, the thoroughness and the effectiveness of ablation can be ensured, the thermal damage to normal myocardial tissues can be reduced to the greatest extent, and the postoperative complication risk is reduced, so that the safety and the success rate of the ablation operation are obviously improved.

The method is easy to realize, and the on-off of each electrode is controlled in a matrix form by arranging an independently controllable switch array in a catheter handle or a connecting module. Thus, a doctor can accurately turn on certain electrodes positioned in abnormal myocardial tissue areas according to the mapping result in operation, and simultaneously turn off the electrodes corresponding to normal myocardial tissue areas. For example, if the mapping shows that there is a lesion below electrode 3 and electrode 5 and that the tissue below electrode 4 and electrode 6 is normal, the physician may only turn on electrode 3 and electrode 5 for rf ablation while electrode 4 and electrode 6 remain off, thereby achieving local precise ablation and reducing damage to normal tissue. In addition, a multi-channel radio frequency generator sub-control mode can be adopted, and different electrodes respectively correspond to independent channels of the radio frequency generator, so that differential control is realized at the source. Or the electrodes can be divided into a plurality of logic groups in advance through electrode grouping control, each group can be independently opened and closed, and a doctor can select the needed grouping in the operation. Although the two modes can realize differential control of the electrodes, the switch array mode is more mature and flexible in terms of system complexity and expandability, and has higher clinical application value.

In some embodiments of the application, the ablation system further comprises an adapter box connected with the ablation instrument, the three-dimensional cardiac electrophysiology mapping system, the ablation catheter and the back electrode patch respectively, wherein the adapter box is used for gating a radio-frequency ablation path or a pulse ablation path between the ablation instrument and the ablation catheter, transmitting data acquired by the ablation catheter in a surgical process to the three-dimensional cardiac electrophysiology mapping system, and constructing a loop between the ablation catheter and the back electrode patch in a monopolar mode.

In a dual energy implementation, two independent energy sources (pulse ablation device and radiofrequency instrument) can be connected to the same pod, respectively, which is connected to the ablation catheter through the catheter tail, so that the pulse ablation device and radiofrequency instrument can communicate through the same pod and catheter to selectively transmit pulse energy or radiofrequency energy to the catheter head for ablation. In a specific application of the system, pulse ablation may be performed when the pulse ablation device is activated, and radio frequency ablation may be performed when the radio frequency meter is activated.

Further, when the function expansion module is arranged in the adapter box of the dual-energy system, various additional functions can be realized. For example, 1) when a back electrode patch connection module is arranged in the transfer box, pulse ablation equipment and a radio frequency instrument can be communicated with the back electrode patch to realize monopolar discharge, 2) when a three-dimensional heart electrophysiology mapping system connection module is arranged in the transfer box, an ablation catheter can be communicated with a three-dimensional mapping system through the transfer box, so that mapping or modeling can be directly carried out in the ablation process, and relevant ablation parameters such as the pressure, impedance value, ablation times, ablation time and the like of the head end of the catheter are displayed in real time.

In addition, the system can be provided with a dual-energy discharge protection and control mechanism, for example, the pulse ablation function is forbidden to be started in the process of performing the radio frequency ablation, and the radio frequency ablation function is forbidden to be started in the process of performing the pulse ablation, so that the two energy sources are prevented from being triggered by mistake in the clinical ablation process, and the safety of dual-energy ablation is obviously improved.

Therefore, through the arrangement of the switching box, on one hand, a radio frequency ablation passage or a pulse ablation passage between the ablation instrument and the ablation catheter can be flexibly gated, so that the same catheter can be switched with different ablation energy types according to the needs, the diversity and adaptability of the ablation mode are improved, and on the other hand, the switching box can transmit signals to the three-dimensional heart electrophysiology mapping system in real time when the ablation catheter collects the signals, and the signals are used for modeling and mapping, so that the dual functions of the catheter are maintained in the operation process. In addition, the transfer box can automatically establish a loop between the ablation catheter and the back electrode patch in a monopolar mode, so that a doctor is prevented from carrying out complex external connection operation in operation. In summary, the introduction of the adapter box not only simplifies the connection relation among the catheter, the ablation instrument and the three-dimensional system, improves the overall operation convenience and stability of the system, but also further enhances the application capability of the catheter in various clinical situations.

Referring to fig. 4-14, there are shown graphs of the ablation effect of the disclosed ablation catheter according to an embodiment of the present application. In fig. 4 to 9, the shape of the ablation focus is represented below the black horizontal straight line. Fig. 4 corresponds to monopolar punctiform ablation, fig. 5 corresponds to bipolar punctiform ablation, fig. 6 corresponds to monopolar linear ablation (full electrode discharge), fig. 7 corresponds to bipolar linear ablation (full electrode discharge), fig. 8 corresponds to monopolar linear ablation (partial electrode discharge), and fig. 9 corresponds to bipolar linear ablation (partial electrode discharge). Concepts of Guan Dianzhuang ablation, linear ablation, monopolar ablation, and bipolar ablation have been described in detail in the above embodiments and are not repeated here. It is clear from fig. 4 to 9 that the application can flexibly form ablation foci with different shapes and sizes by realizing free combination between monopolar ablation and bipolar ablation, punctiform ablation and linear ablation. For example, in the case of local small-area myocardial tissue, monopolar point ablation may be used to form relatively independent small-area lesions, while in the case of larger-area lesions, continuous band-shaped lesions may be formed rapidly by bipolar linear ablation. In addition, in some complicated focus areas, doctors can select a multi-point combination or point-line combination mode according to the mapping result, so that a personalized ablation scheme which meets the actual clinical requirements better is realized. In addition, in the ablation process, proper electrode discharge can be selected according to actual conditions. Therefore, the ablation catheter provided by the application has higher universality and flexibility when adapting to different clinical scenes.

In fig. 10-14, fig. 10-12 selected potatoes as samples for the experiment, and fig. 13 and 14 selected isolated hearts of dead animals as samples for the experiment. Monopolar and bipolar punctiform pulse ablation was used on potatoes, respectively, with the results shown in fig. 10. The experimental conditions of the monopole ablation and the bipolar ablation are completely consistent (namely, the same pulse ablation parameters, the same potatoes, the same saline concentration and the like), the head end of the catheter (or the position called a head electrode, namely, electrode 1) is vertically abutted against the potatoes, the discharge voltage is set to 1800V, the discharge time is set to 5s, the shape of a potato ablation stove is similar to that of a simulation result, the surface of the potato ablation stove is approximately elliptical or circular, the depth of the monopole ablation stove is 6.8mm, and the depth of the bipolar ablation stove is 4.2mm. It follows that the depth of the monopolar lesion is greater than the depth of the bipolar lesion under the same ablation parameters.

Bipolar pulse ablation was used on potatoes with the results shown in fig. 11. Bipolar linear ablation selects electrodes 1 and 2,5, 7 and 9 as positive electrodes and electrodes 3,4, 6, 8 and 10 as negative electrodes. The tip of the tube was horizontally abutted against the potato, and the discharge voltage was set to 900V. The shape of the potato ablation stove is similar to the simulation result, the potato ablation stove is integrally and banded and distributed along the direction of the catheter electrode, and the length of the ablation stove is about 41.9mm. Further, the depth of the potato lesion is deeper (about 6.1mm in depth) near the distal tip electrode of the catheter tip and shallower (about 2.1 mm) near the proximal ring electrode.

The 6 electrodes at the proximal end of the catheter are selected for bipolar pulse ablation on the potatoes, the head end of the catheter horizontally clings to the potatoes, the discharge voltage is set to 900V, the electrode 5, the electrode 7 and the electrode 9 are selected as positive electrodes, the electrode 6, the electrode 8 and the electrode 10 are selected as negative electrodes, and the ablation result is shown in fig. 12. The shape of the potato ablation stove is similar to that of the simulation result, the potato ablation stove is approximately strip-shaped, the length of the potato ablation stove is about 26.0mm, and the depth of the potato ablation stove is about 4.0mm.

Monopolar pulse ablation was used on live animal pigs and the results of the ablation are shown in figures 13 and 14. The electrode 1 is adopted for monopole ablation to discharge the back electrode, the discharge voltage is set to 1500V, the contact force is about 40g, the surface of the potato ablation stove is approximately elliptical or circular, and the depth of the ablation stove is about 10-11 mm.

As can be seen from fig. 10-14, the ablation system of the present application has a similar ablation effect on a real sample (potato or animal heart) as a simulation effect, and has extremely high clinical value.

In some embodiments of the application, the number of the electrode groups is between 10 and 20, the electrode groups comprise a head electrode and a plurality of ring electrodes, the head electrode is arranged at the distal end of the first end, the plurality of ring electrodes are arranged along the direction from the distal end of the first end to the proximal end of the first end, and the pressure sensor is used for transmitting pressure data between the first end and target tissues to the three-dimensional cardiac electrophysiology mapping system in real time so that the three-dimensional cardiac electrophysiology mapping system can determine the leaning condition 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, the diameter of each electrode in the electrode group ranges from 2mm to 4mm, the distance between two adjacent electrodes is 1mm to 5mm except the distance between two adjacent electrodes of the pressure sensor, and the distance between two adjacent electrodes of the pressure sensor is determined by the size of the pressure sensor.

With continued reference to FIG. 1, electrode 1 may be referred to as a head electrode, electrodes 2-10 may be referred to as ring electrodes, and the pressure sensor is 11. The tip electrode 1 is arranged at the distal end of the first end 101, and the ring electrodes are arranged sequentially in the proximal direction of the catheter, wherein the electrode 2 is closest to the electrode 1 and the electrode 10 is furthest from the electrode 1. The total number of electrodes in the electrode set may be between 10-20, in addition to 10 electrodes as shown in fig. 1. By setting the number of the electrodes in the range, on one hand, the electrodes can be ensured to cover a far-end area of the catheter which is long enough to adapt to the requirements of ablation ranges with different lengths and sizes, and the flexibility of clinical application is improved, on the other hand, the excessive number of the electrodes can increase the complexity and manufacturing difficulty of the catheter structure and possibly bring problems of wiring crowding, electric interference and the like, so that the limitation of the number of the electrodes between 10 and 20 can achieve good balance between functionality and manufacturability.

The width range of each ring electrode is between 0.3mm and 3mm, so that the ring electrodes can form uniform and continuous mapping and ablation, and the resolution between the ring electrodes is not reduced due to the overlarge width. The diameter range of the electrode is limited to 2 mm-4 mm, so that the contact area of the electrode is ensured to be sufficient on the one hand, and the whole minimally invasive characteristic of the catheter is maintained on the other hand. The distance between the adjacent two electrodes is in the range of 1mm to 5mm except the distance between the adjacent two electrodes, and the distance between the adjacent two electrodes is determined by the size of the pressure sensor. Therefore, the method can ensure that the multiple electrodes work simultaneously and have good spatial resolution, and avoid the problem of short circuit or overheating caused by too close electrodes, thereby taking the safety and the effectiveness into account.

In some embodiments of the application, at least one ring electrode is disposed between the pressure sensor and the head electrode.

By introducing at least one ring electrode between the two, reasonable electrode distribution can be maintained at the distal end of the catheter, and a continuous electric signal acquisition path is formed. Thus, the problems of overlarge electrode spacing, uneven signal acquisition and the like caused by directly arranging the pressure sensor behind the head electrode can be avoided, and the missing or distortion of electrocardiosignals can be prevented. The structure remarkably improves the accuracy and reliability of the heart electrophysiology mapping, and ensures the clinical applicability of the catheter in the mapping and modeling process.

In some embodiments of the application, each electrode in the electrode group has an impedance detection function and is used for transmitting detected impedance data to an ablation instrument so that the ablation instrument can determine whether each electrode is effectively abutted against target tissue according to a preset impedance range, and the three-dimensional cardiac electrophysiology mapping system is also used for determining whether the target tissue is abnormal myocardial tissue according to the data obtained by mapping the first end part, and when ablation is performed, the ablation instrument defaults to select the electrode which is in an effective abutted state and is abutted against the abnormal myocardial tissue.

In the pulse ablation process, the condition that the catheter electrode is abutted against the tissue has a significant effect on the depth of an ablation focus. Typically, when the catheter electrode is well-abutted against myocardial tissue, the depth of its pulse ablation focus is significantly greater than when not abutted. If the electrode is not effectively attached to the myocardial tissue, the discharge energy may be mainly released into the blood, so that not only is it difficult to form an ablation focus with sufficient depth and stability on the target myocardial tissue, resulting in an increased risk of ablation failure or recurrence, but also the blood may be overheated, resulting in serious complications such as hemolysis and thrombus. Therefore, ensuring effective abutment of the electrode with myocardial tissue and avoiding discharge under ineffective abutment is of great importance to improving the safety and effectiveness of ablation. For this reason, the present embodiment proposes a method for judging the conditions of the plurality of electrodes against myocardial tissue based on impedance detection. When the electrode is attached to myocardial tissue, the impedance value is generally between 200Ω and 250Ω, when the electrode is suspended in blood, the impedance value is generally between 150Ω and 200Ω, and if the impedance value deviates from the above range, it can be determined that the catheter has an abnormal condition. The impedance value obtained through the comparison detection and the preset impedance range can clearly distinguish whether the electrode is well attached to the myocardial tissue or not.

When the impedance of one or more electrodes meets the impedance range when the electrodes are abutted against the cardiac muscle, the electrodes are well abutted against the cardiac muscle tissue, and pulse discharge can be performed, and when the impedance of one or more electrodes meets the impedance range suspended in blood, the electrodes are poorly abutted against the cardiac muscle tissue, and pulse discharge is not allowed. The method can improve pulse discharge efficiency and reduce complications such as hemolysis caused by ineffective discharge while ensuring discharge effect.

In this embodiment, since the number of electrodes is large, the ablation electrode selected in the pulse ablation process is required to be well attached to the myocardial tissue. To achieve this, all electrodes on the catheter may be connected to a special pulsed ablation device, thereby achieving real-time impedance detection. The ablator allows pulse discharge when the impedance is within the desired range, and prohibits pulse discharge when the impedance exceeds the range. Further, when the impedance detection result of part of the electrodes of the catheter shows good adhesion and the impedance detection result of the other electrodes shows poor adhesion, the system can only select electrodes with good adhesion to discharge, and the electrodes with poor adhesion are not discharged, so that the ablation efficiency is effectively improved, and side effects caused by invalid or wrong electrode discharge are avoided.

In addition, the three-dimensional cardiac electrophysiology mapping system also judges whether the target tissue is abnormal myocardial tissue according to the signal returned by the first end part. In ablation, only abnormal myocardial tissue is ablated, and normal myocardial tissue is not ablated. This may be achieved by the third sub-control signal in the above-described embodiment. That is, according to the actual situation, after the mapping electrode marks the abnormal myocardial tissue and the normal myocardial tissue, only the electrode mapping the abnormal myocardial tissue is selected to discharge, and the electrode mapping the normal myocardial tissue is not discharged. The method has the advantages that the local ablation can be realized more accurately, and the damage to normal myocardial tissues is reduced.

In summary, in this embodiment, the impedance detection is used to determine the adhesion condition between each electrode and the myocardial tissue, and selective electrode discharge is implemented based on the detection result, so that the ablation effect is ensured, and meanwhile, the pulse ablation efficiency is improved, and the risk of complications caused by ineffective discharge is reduced.

In some embodiments of the present application, after the catheter electrode enters the heart chamber, impedance detection is performed on each electrode first to determine whether the impedance value of each electrode is within a preset impedance range of the electrode. If the detection result shows that the impedance value is in the range, the system selects the electrode meeting the condition as an ablation electrode and starts pulse ablation operation, and if the detection result shows that the impedance value is not in the range, the electrode is not in effective contact with myocardial tissue, at the moment, an operator (i.e. a doctor) needs to adjust the catheter to improve the contact condition of the electrode and the myocardial tissue, and electrode impedance detection is carried out again. The above steps may be performed in a loop until the impedance value meets the desired range, and pulse ablation may be initiated. The process can ensure that the ablation electrode discharges in an effective leaning state, thereby improving the efficiency and safety of pulse ablation.

In some cases, relying solely on impedance detection may produce false positives. For example, although some electrodes detect impedance values that fall within the range of being held against the myocardium, in practice the electrodes may only slightly contact the myocardial surface, or short fluctuations in impedance values due to blood flow, tissue movement, etc., may be misinterpreted by the system as being effectively held against. By performing the pressure detection simultaneously with the impedance detection, it was found that the electrode was subjected to a pressure of less than 5g, which did not reach the required range for effective abutment. Compared with the embodiment, after the pressure sensor is arranged, the abutting condition of the ablation catheter and the target tissue can be accurately and reliably judged, and whether the ablation catheter is effectively abutted or not can be judged according to impedance detection and pressure detection. In the pressure detection process, when the pressure is detected to be 5 g-20 g, the pressure can be considered to be effectively abutted.

Therefore, by combining the dual judgment of the impedance detection and the pressure detection, false positive results caused by single impedance detection can be avoided, the ablation catheter is ensured to form stable and reliable adhesion with the target tissue truly, and the safety and the accuracy of ablation are further improved.

In summary, the pressure sensor is integrated at the distal end of the catheter, so that the adhesion force between the electrode and myocardial tissue can be displayed in real time, visual and reliable adhesion state information can be provided for an operator, and the impedance detection result can be mutually verified, so that whether the electrode is in an effective adhesion state or not can be accurately judged in the ablation process, and the safety of operation in the operation and the reliability of the ablation effect are improved.

Referring to fig. 16, a diagram of an exemplary structure of a head electrode (without an insulating sleeve) according to an embodiment of the present application is shown. Referring to fig. 17, another example of a structure of a head electrode (with an insulating sleeve) according to an embodiment of the present application is shown. As shown in fig. 16 and 17, the head electrode M has a protrusion N at one end thereof near the pressure sensor (not shown), and the present application provides an insulating sleeve L between the protrusion N and the pressure sensor to electrically insulate the pressure sensor from the protrusion N. Therefore, through the relation of the insulating sleeve, breakdown or damage to the pressure sensor caused by excessive current during electrode working can be effectively avoided, and long-term stable operation of the pressure sensor is ensured.

If the insulating sleeve is not provided, since the protruding portion needs to be connected with the lead wire and conducted with the electrode, when the electrode releases energy, current may be coupled along the protruding portion or leaked to an adjacent pressure sensor, so that the pressure sensor directly bears high voltage impact. On the one hand, this condition is liable to cause dielectric breakdown of the sensor circuit or burning of the device, and on the other hand, even if not immediately damaged, it can cause distortion and drift of the measurement signal, affecting the accuracy and reliability of the pressure detection.

Referring to fig. 18, an enlarged view of a first end of an ablation catheter is shown, in accordance with an embodiment of the present application. As shown in fig. 18, the rigid segment further includes a protective sheath Q disposed at least around the pressure sensor P such that the pressure sensor P is located inside the protective sheath Q and ring electrodes R on the rigid segment are all disposed outside the protective sheath. Furthermore, as can be seen from fig. 18, due to the provision of the insulating sleeve L, electrical insulation is achieved between the pressure sensor P and the protruding portion N of the head electrode M to achieve the objective of protecting the pressure sensor during electrode discharge.

In this embodiment, the protective sheath is arranged at least around the pressure sensor, so that the pressure sensor is located inside the protective sheath, thereby preventing the pressure sensor from directly contacting myocardial tissue, avoiding signal interference and mechanical wear on the one hand, and providing additional rigid support for the pressure sensor and the area where the pressure sensor is located on the other hand, so that the distal end of the catheter can better realize the positioning and supporting functions of the rigid section.

Through the dual protection design of insulating sleeve and protective sheath, pressure sensor not only possesses electrical safety and stability, still possesses the protection nature on the machinery and the structural reliability to show the durability and the clinical applicability that have promoted whole pipe.

In the foregoing embodiments, the descriptions of the embodiments are focused on, and the parts of a certain embodiment that are not described or depicted in detail may be referred to in the related descriptions of other embodiments. Furthermore, the above embodiments can be freely combined as needed.

Claims (10)

1. An ablation system comprising an ablation catheter and an ablation instrument, the ablation catheter comprising a first end for abutting target tissue to be ablated, a second end for connection with the ablation instrument, and a catheter body between the first end and the second end, the ablation catheter being tubular;

The ablator is configured to transmit radiofrequency energy to the ablation catheter to cause the ablation catheter to radiofrequency ablate the target tissue, or the ablator is configured to transmit pulsed energy to the ablation catheter to cause the ablation catheter to pulse ablate the target tissue;

The first end comprises an electrode group, the number of the electrodes in the electrode group is at least 10, the electrode group is configured to acquire electrocardiosignals of a space where the target tissue is located and transmit the electrocardiosignals to a three-dimensional cardiac electrophysiology mapping system so that the three-dimensional cardiac electrophysiology mapping system realizes heart modeling and mapping based on the electrocardiosignals, the electrode group is further configured to receive a control signal from the ablation instrument and ablate the target tissue by utilizing the radio frequency energy or the pulse energy according to the control signal, each electrode in the electrode group has the capability of acquiring the electrocardiosignals and ablating the target tissue, wherein the control signal comprises a first subcontrol signal and a second subcontrol signal, the first subcontrol signal is used for controlling the electrodes in the electrode group to ablate the target tissue in a monopolar mode or a bipolar mode, the electrodes in the electrode group are used for ablation output positive electrode signals, and the electrodes in the electrode group are used for ablation in the monopolar mode and at least one electrode in the bipolar mode are used for ablation, and at least one electrode in the electrode group is used for ablation;

The ablation system further comprises a bending control handle arranged between the second end part and the ablation instrument, wherein the first end part is an adjustable bending section, and the first end part swings around a first point under the control of the bending control handle to determine a mapping area, and the first point is a connecting point of the first end part and the catheter main body;

The first end further comprises a pressure sensor, the first end comprises a flexible section and a rigid section, the pressure sensor and at least two electrodes are arranged on the rigid section, and the rest electrodes in the electrode group are arranged on the flexible section.

2. The ablation system of claim 1, further comprising an adapter box connected to the ablation instrument, the three-dimensional cardiac electrophysiology mapping system, the ablation catheter, and the back electrode patch, respectively;

The junction box is used for gating a radio frequency ablation path or a pulse ablation path between the ablation instrument and the ablation catheter, transmitting data acquired by the ablation catheter in a surgical process to the three-dimensional cardiac electrophysiology mapping system, and constructing a loop between the ablation catheter and the back electrode patch in the monopolar mode.

3. The ablation system of claim 1, wherein the control signals further comprise a third sub-control signal for determining the number and location of electrodes in the electrode set for ablation.

4. The ablation system of claim 1, wherein the ablator sets the second sub-control signal to spot ablate the target tissue when the first sub-control signal controls electrodes in the electrode set to ablate in a monopolar mode.

5. The ablation system of claim 1, wherein the ablator sets the second sub-control signal to linearly ablate the target tissue when the first sub-control signal controls the electrodes of the electrode set to ablate in a bipolar mode.

6. The ablation system of claim 1, wherein the number of electrode sets is between 10-20, and the electrode sets include a head electrode disposed distally of the first end portion and a plurality of ring electrodes arranged in a direction from the distal end of the first end portion to the proximal end of the first end portion;

the pressure sensor is used for transmitting pressure data between the first end part and the target tissue to the three-dimensional heart electrophysiology mapping system in real time so that the three-dimensional heart electrophysiology mapping system can determine the abutting condition of the first end part;

The width of the head electrode ranges from 1.5mm to 5mm, the width of each ring electrode ranges from 0.3mm to 3mm, the diameter of each electrode in the electrode group ranges from 2mm to 4mm, the distance between two adjacent electrodes ranges from 1mm to 5mm except the distance between two adjacent electrodes of the pressure sensor, and the distance between two adjacent electrodes of the pressure sensor is determined by the size of the pressure sensor.

7. The ablation system of claim 6, wherein at least one of the ring electrodes is disposed between the pressure sensor and the head electrode.

8. The ablation system of claim 6, wherein each electrode in the set of electrodes has an impedance detection function and is configured to transmit detected impedance data to the ablation instrument to cause the three-dimensional cardiac electrophysiology mapping system to determine whether each electrode is in effective abutment with the target tissue according to a preset pressure range and the ablation instrument according to a preset impedance range;

The three-dimensional cardiac electrophysiology mapping system is further used for determining whether the target tissue is abnormal myocardial tissue according to the data obtained through mapping at the first end, and the ablation instrument defaults to select an electrode which is in an effective leaning state and is leaning against the abnormal myocardial tissue for ablation when the ablation is performed.

9. The ablation system of claim 6, wherein an end of the head electrode proximate the pressure sensor has a protrusion and an insulating sleeve is disposed between the protrusion and the pressure sensor to electrically insulate the pressure sensor from the protrusion.

10. The ablation system of claim 6, wherein the rigid segment further comprises a protective sheath disposed at least around the pressure sensor such that the pressure sensor is located inside the protective sheath and ring electrodes on the rigid segment are each disposed outside the protective sheath.