CN111728693A - System for treating arrhythmia by adopting pulsed electric field ablation technology - Google Patents

Abstract

The invention provides a system for treating arrhythmia by adopting a pulsed electric field ablation technology, which comprises a voltage pulse system console, a pacing and ECG unit and an ablation catheter. The voltage pulse system console includes an electrical pulse generator, a controller, a human-machine interface, and a converter. The pacing and ECG unit comprises an ECG recorder, a pacing catheter, a cardiac stimulator and a mapping catheter, and pacing electric signals are synchronously transmitted to a voltage pulse system console. The ablation catheter is connected to a system console via a transducer, and based on the pacing signal, delivers a voltage pulse waveform during a refractory period of the cardiac cycle, delivering pulsed electric field energy to the ablated tissue via electrodes on the ablation catheter. The ablation catheter comprises a spline basket, the distal end of the spline basket is also provided with an annular catheter entering the pulmonary vein, and large-area irreversible injury in local, linear, annular or uniform distribution can be formed, so that the purpose of treating arrhythmia diseases such as atrial augmentation, supraventricular tachycardia and atrial fibrillation is achieved.

Description

System for treating arrhythmia by adopting pulsed electric field ablation technology

Technical Field

The invention belongs to the field of medical instruments, relates to a system for treating arrhythmia by adopting a pulsed electric field ablation technology, and particularly relates to a multipolar irreversible electroporation ablation catheter for treating arrhythmia.

Background

Cardiac ablation has experienced a great deal of innovation and rapid development since its first implementation in 1969. Ablation was first used for the treatment of supraventricular tachycardia patients with accessory pathways and pre-excitation syndrome, and today ablation is commonly used for the treatment of atrial flutter, atrial fibrillation and ventricular arrhythmias.

The purpose of ablation is to destroy potentially arrhythmic tissue and form transmural and continuous permanent lesions. Percutaneous catheter ablation to achieve Pulmonary Vein (PV) isolation in atrial tissue using Radio Frequency Ablation (RFA) and cryotherapy has become a widely accepted procedure for treating Atrial Fibrillation (AF). Other forms of energy developed for catheter ablation include microwaves, high intensity focused ultrasound, low intensity collimated ultrasound, lasers, cryogenic energy, and heated saline.

Radio Frequency (RF) energy is currently the most commonly used energy source. RF creates lesions by resistively heating tissue and then conducting heat to deeper tissue. Although quite effective, it adversely affects not only the targeted tissue but also other surrounding tissue structures due to its inherent thermal conductivity properties. Especially during radiofrequency ablation, heat transfer can lead to esophageal damage (esophageal fistula formation), nerve septal damage, pulmonary vein stenosis, coagulum/thrombosis and subsequent risk of thromboembolism, all of which can lead to cerebral infarction or injury.

Cryoablation is another widely used mode of ablation, unlike radiofrequency. It ablates tissue by removing heat, causing the tissue to cool and freeze. However, like RF, cryoablation also causes complications including esophageal fistulas, stenosis of the Pulmonary Veins (PV), neuroparalysis and potentially pulmonary hemoptysis. Although both of these energy sources for ablation are effective to a large extent, it is desirable to attempt to improve ablation safety using alternative ablation energy sources.

Irreversible electroporation (IRE) is a rapidly developing, recognized and FDA approved solid tumor treatment, recently approved for the treatment of pancreatic cancer. Direct Current (DC) in the form of pulses is used to generate a local electric field that affects the permeability of the lipid bilayer of the cell membrane, thereby inducing the formation of nanoscale defects or pores, resulting in increased permeability of the cell. Depending on the electrical pulse parameter settings (e.g., pulse duration, voltage, frequency), this may be a reversible process, i.e., cells may survive through the reestablishment of cell membrane integrity and homeostasis, or irreversible electroporation leads to cell death.

IRE may be a promising approach for cardiac ablation, especially in comparison to RF, which can produce lesions without the consequence of thermal conduction, i.e. be able to preserve the surrounding tissue structure. In this Field, IRE is more commonly called Pulsed Field Ablation (PFA), and since PFA has potential advantages over the current Ablation methods, many preclinical animal experimental studies have been made, and recently, short-term clinical data of human body have been published for the first time. The annular pulmonary vein ablation catheter is used for delivering a pulse electric field to generate myocardial damage, the success rate of PFA acute isolation of pulmonary veins is 92.0%, and the method is proved to be a novel ablation method with potential, rapidness and safety. Reddy et al summarized two small-scale short-term human clinical studies with a PFA ablation parameter improvement with a 3-month pulmonary vein isolation success rate of 100% without stroke, nerve damage, PV stenosis and esophageal injury. The success rate of arrhythmia in 12 months is 87.4%.

This patent is to ablation system of PFA technical innovation design, can improve by a wide margin and melt efficiency and security, is applied to arrhythmia treatment field, expects to reach the purpose of diseases such as quick, safe, effectual treatment arrhythmia.

Disclosure of Invention

The invention aims to provide a system for treating arrhythmia by adopting a pulsed electric field ablation technology, which comprises a voltage pulse system console, a pacing and ECG unit and an ablation catheter.

The voltage pulse system console includes an electrical pulse generator, a controller, a human-machine interface, and a converter.

The pacing and ECG unit comprises an ECG recorder, a pacing catheter, a cardiac stimulator and a mapping catheter, and pacing electric signals are synchronously transmitted to a voltage pulse system console.

The ablation catheter comprises a distal section, a main body middle section and a proximal section control handle which are sequentially connected.

The ablation catheter is connected to a system console via a transducer, and based on the pacing signal, delivers a voltage pulse waveform during a refractory period of the cardiac cycle, delivering pulsed electric field energy to the ablated tissue via electrodes on the ablation catheter. During an ablation discharge, the transducer isolates the pacing and ECG units from the pulse system console.

The distal section of the ablation catheter includes at least one spline basket formed of flexible, extendable splines, each spline having at least one electrode thereon.

Preferably, the splined basket preferably has 2 to 4 electrodes per spline.

The spline basket is preferably 1 or 4-10 splines. In one embodiment, the splined basket includes 1 spline. In another embodiment, the splined basket preferably comprises 4 to 10 splines.

In one embodiment, the spline circular tube body is a circular tube made of flexible high polymer insulating materials, an insulated conducting wire in an insulated high polymer hose is connected with an electrode embedded on the surface of the spline, and the insulated conducting wire is connected to an electric socket of the control handle through the catheter body.

Preferably, the outer diameter of the spline circular tube is 0.2-3 mm, the inner diameter of the spline circular tube is 0.1-2.9 mm, and the length of the spline is 10-60 mm.

In one embodiment, the extendable flexible spline proximal end is connected to the catheter body intermediate section; the distal end of the spline is fixed on a guide rod with an inner cavity, the guide rod is directly connected to a rotary handle or a push rod of a control handle at the proximal section of the catheter, and can also be connected to the handle through a pull wire, and the spline at the distal section can be formed into a spline basket or the spline basket is folded into an extending state through the control handle.

When a plurality of splines are provided, in a state of opening to form a spline basket, the splines are uniformly distributed on a basket-shaped sphere of 360 degrees in three-dimensional space.

In one embodiment, each electrode on the spline is annular, the outer diameter of each annular electrode is 0.3-3 mm, and the length of each annular electrode is 1-20 mm; the electrodes are insulated and separated by elastic electric insulating high molecular materials, and the electric insulation is more than 500V.

In one embodiment, the voltage pulse system console can address each electrode on the spline; further, electrodes on adjacent splines are selected to carry out positive and negative paired discharge, and positive and negative paired discharge ablation can also be carried out on different electrodes on the same spline.

In one embodiment, the distal section of the ablation catheter further comprises an annular catheter connected to the distal end of the spline basket; the structure of the annular conduit is preferably an annular formed by one circular ring, a cylindrical or spiral conical formed by more than two circular rings; the annular conduit has at least one electrode thereon.

Preferably, the annular outer diameter of the annular conduit in the expanded state is 10-30 mm; the number of electrodes is 5-15; the length of the electrode is 1-4 mm.

Further, the voltage pulse system console can address each electrode of the annular catheter, so that the electrodes in the annular catheter are selected for ablation by discharging, and the voltage pulse system console can also be matched with the electrodes on the spline basket for ablation by discharging.

In one embodiment, two adjacent electrodes in the annular catheter are set as positive and negative electrodes, and pulse discharge ablation is completed sequentially or simultaneously.

The beneficial technical effects obtained by the invention are as follows:

1) the ablation catheter comprises a spline basket, the distal end of the spline basket is also provided with an annular catheter entering the pulmonary vein, except for the discharge ablation of the electrode on the spline basket at the opening of the pulmonary vein, the electrode on the annular catheter can be paired in the pulmonary vein for discharge ablation, and the electrode on the spline basket and the electrode on the annular catheter can also be paired for bipolar discharge ablation, so that the ablation range is increased from the conventional annular ablation of the pulmonary vein opening to the annular ablation in the pulmonary vein and the cylindrical ablation between the two rings, the ablation area is rapidly enlarged, and the purpose of effectively isolating the pulmonary vein for a longer period is achieved.

2) The electrodes in the control spline basket and the annular catheter are selected to perform discharge ablation, so that large-area irreversible damage in local, linear, annular or uniform distribution can be formed, and the purpose of treating arrhythmia diseases such as atrial augmentation, supraventricular tachycardia and atrial fibrillation is achieved.

3) This annular catheter can get into pulmonary vein through melting the wire guide chamber of pipe, and the pulmonary vein's of annular catheter location makes better fixing of spline basket at the pulmonary vein mouth, improves the better and tissue contact of electrode on it, improves the efficiency of melting of pulmonary vein mouth, and then forms complete pulmonary vein and keeps apart. In addition, the annular catheter can also detect the effect of pulmonary vein isolation in time.

Drawings

The accompanying drawings, which are included to provide a further understanding of the invention and are incorporated in and constitute a part of this application, illustrate embodiment(s) of the invention and together with the description serve to explain the invention without limiting the invention. In the drawings:

FIG. 1 is a schematic diagram of a pulsed electric field ablation system according to the present invention;

FIG. 2 is a schematic view of the general construction of the pulsed electric field ablation catheter of the present invention;

FIG. 3 is a schematic structural view of one embodiment of a spline basket of the present invention;

FIG. 4 is a schematic structural view of a second embodiment of a splined basket of the present invention;

FIG. 5 is a schematic structural view of a third embodiment of a spline basket of the present invention;

FIG. 6 is a schematic structural view of a fourth embodiment of a spline basket of the present invention;

FIG. 7 is a schematic structural view of one embodiment of the annular duct of the present invention;

FIG. 8 is a schematic structural view of a second embodiment of the annular duct of the present invention;

FIG. 9 is a schematic structural view of a third embodiment of the annular duct of the present invention;

FIG. 10 is a schematic view of the overall configuration of a distal catheter in accordance with one embodiment of the present invention;

FIG. 11 is a schematic view of the extended configuration of the distal ring catheter of one embodiment of the present invention.

Detailed Description

Technical solutions of the present invention will be described in detail below by way of embodiments with reference to the accompanying drawings. It should be noted that the description of the embodiments is provided to help understanding of the present invention, but the present invention is not limited thereto.

As shown in FIG. 1, a system for treating cardiac arrhythmia using pulsed electric field ablation techniques generally includes a voltagepulse system console 110, a pacing andECG unit 120, and anablation catheter 130.

The voltagepulse system console 110 includes anelectrical pulse generator 114, a controller 113 (containing a processor), a human-machine interface 111 with a display, and aconverter 112.

Theablation catheter 130 is connected to the system console via thetransducer 112, and the pulsed electric field is delivered to the ablated tissue via electrodes on the ablation catheter; during an ablation discharge, the transducer isolates the pacing and ECG units from the pulse system console.

A pacing andECG unit 120 including anintracardiac stimulator 121, anECG recorder 122, amapping catheter 124, a pacingcatheter 125, and aconnector 123, the pacing electrical signals being delivered synchronously to the voltagepulse system console 110; based on the pacing signal,system console 110 issues an ablation pulse into the tissue within the refractory window. In embodiments thereof, the refractory window follows the ventricular pacing signal, or a short lag, and lasts no more than 130ms, with the entire ablation discharge being within the interval.

Anablation catheter 130 includes a distal section 131 (in the body), abody mid-section 132 and aproximal section 133 connected in series.

Fig. 2 is a schematic view showing the overall structure of the pulsed electric field ablation catheter of the present invention. Thedistal segment 131 includes, among other things, a treatment tip, such as a splined basket and/or an annular catheter.

The main bodymiddle section 132 is a slender tube, and includes a hollow inner cavity, and a catheter, an electric wire, a guide wire and the like are disposed in the inner cavity.

Theproximal body segment 133 contains acontrol handle 331. thehandle 331 includes acomponent 332 for receiving a guidewire or other therapeutic device, and thehandle 331 includes aconnector 336 connected to the body of the handle. Thehandle 331 may include apull assembly 335 for manipulating the head member of thedistal segment 131, a lever orknob 334, and an actuator 333. The proximal end of thepull assembly 335 may be anchored to a member, such as a cam, in communication with the lever orknob 334 and responsive to the lever orknob 334. An actuating member 333 is movably coupled to the proximal portion of the catheter and/or handle 331 to manipulate and move thedistal segment 131 treatment head member. The actuator 333 may comprise a sliding key, button, rotating lever, or other mechanical structure movably connected to a handle or catheter.

The catheter of themiddle section 132 of the main body is a woven mesh tube with excellent torsion control performance, the inner cavity of the mesh tube is of a single-cavity or multi-cavity structure, and the insulating material of the inner cavity is TPU or Pebax, and can also be polyimide, FEP, ETFE or PTFE with smaller friction coefficient and better insulating performance; the middle mesh grid is woven by stainless steel, Nitinol and other alloy wires; the outer layer is made of biocompatible electric insulating materials such as TPU, Pebax, nylon and the like.

Themiddle section 132 of the ablation catheter is woven with a mesh tube, if the ablation catheter is of a single-cavity structure, a guide wire cavity is formed by TPU, PeBax, silicone rubber, polyimide, FEP, ETFE and PTFE tubes, and the far end of the guide wire cavity extends into the spline basket; the proximal end enters the handle, and forms a guidewire lumen with the cavity on the luer fitting through which the guidewire and the annular mapping catheter pass directly to the pulmonary vein.

The ablation catheterdistal section 131 can also be a mesh-covered balloon, and electrodes embedded in the balloon surface complete the discharge ablation.

Thedistal section 131 of the ablation catheter can also have an annular multi-pole structure, the catheter is adapted to a pulmonary vein opening and has an outer diameter of 2-5 cm, the number of the electrodes is 4-16, two adjacent electrodes are arranged as an anode and a cathode, pulse discharge ablation is sequentially completed, and complete pulmonary vein isolation is formed.

The ablation catheter is connected to a system console via a transducer, and based on the pacing signal, the pulse generator is programmed to deliver to the electrodes high voltage pulses, either unidirectional pulses or bidirectional pulses, or other combinations, sufficient to cause irreversible electroporation of myocardial tissue cells within the refractory window. The method comprises the following steps of voltage ranging from 100 to 3500V, pulse width ranging from 10 to 1500 microseconds, pulse interval ranging from 10 to 2000 microseconds and pulse sequence ranging from 1 to 500 milliseconds, wherein each ablation part can be single-pulse-train ablation or multi-pulse-train ablation to form irreversible tissue electroporation denaturation.

As shown in FIGS. 3-6, in the head piece of thedistal segment 131, thesplined basket 50 preferably has 1 or 4-10 multiple flexibly extendable splines.

At least oneelectrode 52 is provided on each spline, and theseelectrodes 52 deliver high voltage pulses to the tissue, which can also be used for mapping. The splined basket comprises 2 to 14 flexiblyextendable splines 51, preferably 4 to 10splines 51; there are 1 to 6conductive electrodes 52, preferably 2 to 4electrodes 52 on eachspline 51.

The spline basket comprises 1 ormore splines 51 made of flexible high polymer insulating materials, an insulated wire in an insulated high polymer hose is connected with a plurality ofelectrodes 52 embedded on the surface of a round spline tube, and the insulated wire is connected to an electric socket of the control handle through a catheter main body. The spline main body circular tube is a tube made of flexible high polymer insulating materials, and comprises but is not limited to polyimide, FEP, TPU, Pebax, nylon and silica gel, an insulated wire in the insulated high polymer hose is connected with an electrode embedded on the surface of the spline, and the insulated wire is connected to an electric socket at the near end of the handle through the catheter main body.

Preferably, the outer diameter of the round tube of thespline 51 is 0.2-3 mm, the inner diameter is 0.1-2.9 mm, and the length of the round tube of the spline is 10-60 mm.

In one embodiment, the expandableflexible spline basket 50 is attached proximally to thecatheter 210 in the midsection of the catheter body; the distal end of the spline is secured to afastener 53 having an internal cavity. The fastener and guiderod 54 with lumen are connected by a pull wire to a knob or push rod of a proximal control handle by which the distal spline can be formed into a splined basket or retracted into an extended state.

As shown in fig. 3, in one embodiment, thespline basket 50 includes 8 splines 51. As shown in fig. 4, in one embodiment, thespline basket 50 includes 6 splines 51.

When a plurality ofsplines 51 are provided, in a state where thespline basket 50 is opened to form a basket shape, the splines are uniformly distributed on a basket-shaped sphere of 360 degrees in three-dimensional space.

As shown in fig. 5 and 6, in one embodiment, thesplined basket 50 includes 1 splinedcircular tube 51 in the form of a large middle and two small spiral basket-like structure.

In one embodiment, eachelectrode 52 on the spline is annular, and the outer diameter of theannular electrode 52 is 0.3-3 mm, and the length is 1-20 mm; theelectrodes 52 are insulated and separated by an elastic electric insulating polymer material, and the electric insulation is more than 500V.

In one embodiment, the voltage pulse system console can address eachelectrode 52 on the spline; further, theelectrodes 52 on the adjacent splines are selected to perform positive and negative paired discharge, and positive and negative paired discharge ablation can also be performed ondifferent electrodes 52 on the same spline.

As shown in fig. 3-6, a plurality of extendable flexible splines are attached proximally to thecatheter 210 in the midsection of the catheter body; the distal end of each spline is secured to afastener 53 having an internal cavity.

In one embodiment, the ablation catheter handle 331 has a slider bar, gear and pull wire configuration therein. The pull wire of one set of mechanism is connected with thespline basket 50, and the spline basket is formed by rotating or pushing and pulling on thehandle 331, or the spline basket is collected by straightening the spline, so that preparation is made for repositioning or ablating other pulmonary veins. The pull wire of the other set of position control mechanism is connected to the proximal end of the spline basket, and the direction of the spline basket is controlled through a knob on the handle or a push button, so that the spline basket is perfectly attached to pulmonary vein orifices in different directions.

The fixingpiece 53 is connected to a rotary handle or a push rod of the proximal handle through a pull wire, and the spline of the distal section is formed into a spline basket or is folded into a straight state through the handle; under the state of forming the spline basket by opening, all the splines are uniformly distributed on the basket-shaped sphere of 360 degrees in three-dimensional space.

Each electrode on the flexible spline is annular, the outer diameter of each annular electrode is 0.3-3 mm, and the length of each annular electrode is 1-20 mm; the electrode material is selected from platinum, platinum alloy, gold alloy, silver, stainless steel, nickel-titanium alloy and graphene; the electrodes are isolated by elastic electric insulating high molecular materials, and the electric insulation is more than 500V.

The voltagepulse system console 110 can address eachelectrode 52, select theelectrodes 52 on adjacent splines to discharge in positive and negative pairs, or perform ablation in positive and negative pairs withdifferent electrodes 52 on the splines, or other combinations of discharges.

The wire guide cavity in the center of the spline basket is made of insulating materials such as polyimide, PEEK, PTFE, FEP, ETFE, TPU and Pebax.

As shown in fig. 7-9, another configuration of the ablation catheter is: the distal section, in addition to the splined basket, has anannular conduit 60 attached to the distal end of the splined basket; the annular duct comprises an insulatingcircular tube 61. The outer wall of theannular duct 60 has a plurality ofelectrodes 62.

Thecircular tube 61 is a tube made of a flexible polymer insulating material, and includes but is not limited to polyimide, FEP, TPU, Pebax, nylon, and silica gel, an insulated wire in the insulated polymer hose is connected with an electrode embedded on the surface of the spline, and the insulated wire is connected to an electrical socket at the proximal end of the handle through the catheter main body.

As shown in fig. 7-9, the structure of the ring conduit preferably comprises a ring formed by one ring (fig. 7), a cylinder formed by more than two rings (fig. 8) or a spiral cone (fig. 9);

in one embodiment, the distalannular catheter 60 has an annular outer diameter of 10 to 30 mm, preferably 15 to 20 mm, in the expanded state; the number of the electrodes is 5 to 15, preferably 6 to 10. The length of the electrode is 1 to 4 mm, preferably 1.5 to 3 mm.

Theloop catheter 60 can enter the pulmonary vein, effectively detect pulmonary vein isolation, and also can be used for electrospark ablation, and the loop catheter enters the pulmonary vein through a guide wire cavity of the ablation catheter.

In one embodiment, twoadjacent electrodes 62 in thering catheter 60 are configured as positive and negative electrodes, and the pulsed discharge ablation is performed sequentially or simultaneously to form a complete pulmonary vein isolation.

Further, the voltagepulse system console 110 may address eachelectrode 62 of the ring catheter, selecting theelectrode 62 among them for spark ablation; and then the electrodes in the spline basket are selected for discharge ablation, or the electrodes and the electrodes on the spline basket are matched and combined for discharge ablation.

As shown in FIG. 10, themain body tube 61 of theannular catheter 60 extends from the lumen of theguide rod 54 of thesplined basket 50 through the lumen of thefastener 53, wherein a plurality of extendableflexible splines 51 are attached proximally to thecatheter 210 at the mid-section of the catheter body; thespline basket 50 has a distal end of eachspline 51 secured to afastener 53 having an internal lumen, and theguide rod 54 is retractable from thecatheter 210 to control the expansion of the spline basket. The proximal control handle may control the extension of the loopedcatheter 60 over the guide wire.

In one embodiment, the voltagepulse system console 110 can address eachelectrode 62 of the annular catheter and eachelectrode 52 of the spline basket, select adjacent ones of which to discharge ablate thecombination 62, thereby achieving stereoscopic cylindrical ablation.

The various combinations of different electrode arrangements and addressable electrodes at the far section of the catheter contacting the tissues form various high-voltage pulse electric field modes, for example, the electrode position and the electrode potential are set by adjusting, the electrodes on the annular catheter and the electrodes on the spline basket carry out multi-combination discharge, the discharge in a larger range is realized, and the discharge ablation area is more sufficient compared with that between two electrodes which are only adjacent. Thereby forming large area irreversible damage with local, linear, annular, conical or even distribution, and achieving the purpose of long-term treatment of different arrhythmia diseases such as atrial augmentation, supraventricular tachycardia, atrial fibrillation, etc.

FIG. 11 is a schematic view of the extended configuration of the distal ring catheter of one embodiment of the present invention. Wherein theguide wire 70 extends outside thering catheter 60. Theannular catheter 60 is extendable in a linear fashion to facilitate movement within the blood vessel; the guide wire is drawn out, and the annular catheter returns to a flexible annular shape to automatically adapt to the size of the pulmonary vein.

The above description is only a preferred embodiment of the present invention and is not intended to limit the present invention, and various modifications and changes may be made by those skilled in the art. Any modification, equivalent replacement, or improvement made within the spirit and principle of the present invention should be included in the protection scope of the present invention.

Claims (12)

1. A system for treating arrhythmia by adopting a pulsed electric field ablation technology is characterized by comprising a voltage pulse system console, a pacing and ECG unit and an ablation catheter;

the voltage pulse system console comprises an electric pulse generator, a controller, a human-computer interface and a converter;

the pace-making and ECG unit comprises a cardiac stimulator, an ECG recorder, a pace-making catheter, a mapping catheter and a connector, and pace-making electric signals are synchronously transmitted to a voltage pulse system console;

the ablation catheter comprises a far section, a main body middle section and a near section control handle which are sequentially connected; the ablation catheter is connected to a system console through a converter, and a pulse electric field is transmitted to the ablation tissue through an electrode on the ablation catheter; during an ablation discharge, the transducer isolates the pacing and ECG units from the pulse system console.

2. The system for treating cardiac arrhythmia using pulsed electric field ablation technique of claim 1 wherein the distal section of the ablation catheter includes at least one spline basket of flexible stretchable splines with at least one electrode on each spline.

3. The system for treating arrhythmia using pulsed electric field ablation technique according to claim 2 wherein the splined basket is preferably 1 or 4-10 splines; there are preferably 2 to 4 electrodes on each spline.

4. The system for treating arrhythmia according to claim 3, wherein the splined tubular body is a tubular body made of flexible polymer insulation material, and the insulated wires in the insulated polymer flexible tube are connected with the electrodes embedded on the surface of the spline, and the insulated wires are connected to the electrical socket of the control handle through the catheter body.

5. The system for treating arrhythmia according to claim 4, wherein the spline tube has an outer diameter of 0.2-3 mm, an inner diameter of 0.1-2.9 mm, and a spline length of 10-60 mm.

6. The system for treating arrhythmia using pulsed electric field ablation technique of claim 4 wherein the extendable flexible spline proximal end is attached to the catheter body intermediate section; the distal end of the spline is fixed on a guide rod with an inner cavity, the guide rod is directly connected to a rotary handle or a push rod of a control handle at the proximal section of the catheter, and can also be connected to the handle through a pull wire, and the spline at the distal section can be formed into a spline basket or the spline basket is folded into an extending state through the control handle.

7. The system for treating arrhythmia using pulsed electric field ablation technique of claim 2 wherein each electrode on the spline is annular, the outer diameter of the annular electrode is 0.3-3 mm, and the length of the annular electrode is 1-20 mm; the electrodes are insulated and separated by elastic electric insulating high molecular materials, and the electric insulation is more than 500V.

8. The system for treating cardiac arrhythmia using pulsed electric field ablation technique of claim 3 where the voltage pulse system console can address each electrode on the spline; further, electrodes on adjacent splines are selected to carry out positive and negative paired discharge, and positive and negative paired discharge ablation can also be carried out on different electrodes on the same spline.

9. The system for treating arrhythmia using pulsed electric field ablation technique of claim 2 wherein the distal section of the ablation catheter further has a ring catheter attached to the distal end of the splined basket; the structure of the annular conduit is preferably an annular formed by one circular ring, a cylindrical or spiral conical formed by more than two circular rings; the annular conduit has at least one electrode thereon.

10. The system for treating arrhythmia using pulsed electric field ablation technique according to claim 9 wherein the annular catheter has an outer annular diameter of 10-30 mm in the extended state; the number of electrodes is 5-15; the length of the electrode is 1-4 mm.

11. The system for treating arrhythmia using pulsed electric field ablation technique of claim 9 where the voltage pulse system console addresses each electrode of the ring catheter to select which electrode to perform spark ablation or to perform a paired combination with electrodes on the spline basket to perform spark ablation.

12. The system for treating arrhythmia using pulsed electric field ablation technique according to claim 9, wherein two adjacent electrodes in the ring catheter are set as anode and cathode to complete the pulsed discharge ablation sequentially or simultaneously.

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