CN215306625U

CN215306625U - Pulse ablation electrode assembly and pulse ablation catheter

Info

Publication number: CN215306625U
Application number: CN202120165686.5U
Authority: CN
Inventors: 洪光; 熊庆文; 谢志杰
Original assignee: Chengdu Feiyun Technology Co ltd
Current assignee: Chengdu Feiyun Technology Co ltd
Priority date: 2021-01-21
Filing date: 2021-01-21
Publication date: 2021-12-28
Anticipated expiration: 2031-01-21

Abstract

The utility model relates to a pulse ablation electrode assembly which comprises a first electrode and a second electrode, wherein opposite ends of the two electrodes are gradually contracted bulges, and an insulating layer is arranged between the opposite ends of the two electrodes. The utility model also relates to a pulse ablation catheter. The utility model can more safely, effectively and conveniently use the pulse electric field to ablate the tissue.

Description

Pulse ablation electrode assembly and pulse ablation catheter

Technical Field

The utility model relates to a medical appliance, in particular to a pulse ablation electrode assembly and a pulse ablation catheter.

Background

Radiofrequency ablation and cryoablation are two common methods for treating arrhythmia and tumor clinically at present. Today, pulsed electric field technology has also emerged, where a brief high voltage is applied to tissue cells, which can produce a local high electric field of several hundred volts per centimeter or more: the local high electric field disrupts the cell membrane by creating pores in the cell membrane where the applied electric field is above the cell threshold such that the pores do not close, and such electroporation is irreversible, thereby allowing biomolecular material to exchange across the membrane, resulting in cell necrosis or apoptosis. The irreversible electroporation of pulse is different from the physical therapy of radio frequency, refrigeration, microwave, ultrasound and the like in the thermal ablation principle, and the irreversible electroporation damage of microsecond pulse to myocardial cell membranes is a non-thermal biological effect and can effectively avoid the injury of blood vessels, nerves and esophagus. The electric field pulse with the high-frequency pulse electric field maintaining the irreversible electroporation non-thermal advantage is expected to break through the cell membrane capacitance effect and the problem of uneven internal electric field distribution caused by the anisotropy of biological tissues. The bipolar pulse is used, namely, after the previous pulse with positive polarity is finished, a negative polarity pulse train with the same pulse width and equal field intensity is applied next to the pulse with positive polarity, so that when the action potential induced by the positive pulse is not generated sufficiently, the action potential is stimulated by the following negative pulse to develop in the opposite direction, and the nerve stimulation caused by the electric field is reduced. Because the threshold value of different tissue cell penetration is different, the high-voltage pulse technology can be used for selectively treating the myocardial cells (the threshold value is relatively low), and does not influence other non-target cell tissues (such as nerves, esophagus, blood vessels and blood cells), and meanwhile, because the time for releasing energy is extremely short, the pulse technology can not generate heat effect, thereby avoiding the problems of tissue dementia, pulmonary vein stenosis and the like. In the existing pulse ablation technology, because of the structure and the working mode of a catheter, an electrode and a working mode, the distance between two adjacent opposite electrodes is far, high voltage as high as 3000 plus 5000V is often required to be output to generate a required electric field so as to achieve a clinically effective result, so that a patient needs to be fully anesthetized in an operation, risks of blood tissue hydrolysis, gasification, scabbing and the like can be brought, and even the tissue is burnt and attached to the surface of the electrode, so that serious medical accidents are caused; meanwhile, the space of the applied pulse electric field is large, the ablation depth is deep, and the lesion tissue is ablated while the normal tissue is obviously damaged. If the distance between the electrodes is simply adjusted to realize a smaller effective pulse electric field space and a lower working voltage, so as to improve the precision of pulse ablation and avoid the damage of normal tissues, in this situation, the electrode with a smaller volume generally occupies a larger space proportion relative to the whole pulse electric field, for example, in the situations of radio frequency ablation and unipolar pulse ablation, the distance between the electrodes is about 10cm, the distance between the pulse electrodes is reduced to be below the size of the electrode, generally, the size of the electrode is 2-6 mm, because the distance between the electrodes is shortened, the electric field intensity difference at two ends of a single electrode is obviously improved, and a weaker electric field generated by the action of the two electrodes far away from each other still needs to ensure an electric field with enough strength so as to realize effective ablation; the electric field generated at the adjacent ends of the two electrodes is significantly greater than the electric field of the required strength. If the voltage between the two electrodes is further reduced, the pulse intensity of the adjacent ends of the electrodes meets the requirement, and the risk that the adjacent ends of the two electrodes scorch and scab human tissues is prevented, namely, an electric field meeting the strength is generated only in a micro range between the outer edges of the shortest distance between the two electrodes, the pulse electric field at the opposite ends of the two electrodes and at the side surfaces of the electrodes is obviously lower than the required pulse electric field, so that effective ablation cannot be realized, on the actual clinical pulse ablation, the required pulse electric field intensity meeting the requirement is generated in an electric field space with the required volume of the effective pulse electric field space, generally, the electrode intervening in the human body has a small volume, the electric field space in the micro range between the outer edges is too small, the ablation part is too small, the linear ablation operation workload is huge, the treatment times are many, the treatment effect is poor, meanwhile, the ablation depth is not enough, and the whole ablation effect is poor or even no effect, in order to ensure an effective electric field space, a relatively large electric field space is usually covered on the outer side of the whole electrode, and meanwhile, the electric field intensity in the electric field space meets the ablation requirement, and an effective technical scheme for avoiding the above damage is not available in the prior art.

Disclosure of Invention

The utility model aims to overcome the defects of the prior art and provides a pulse ablation electrode assembly and a pulse ablation catheter, which can ablate tissues by using a pulse electric field more safely, more effectively and more conveniently.

The purpose of the utility model is realized as follows: the utility model provides a pulse ablation electrode subassembly, includes first electrode and second electrode, the opposite ends of two electrodes are the arch of contracting gradually, bellied surface is the arcwall face, sets up the insulating layer between the opposite ends of two electrodes.

The surface of the protrusion is a rotating curved surface, and a rotating bus of the rotating curved surface is a convex curve.

The first electrode is of a spherical structure, the convex surface of the first electrode is a spherical crown surface, the second electrode is of a hollow tubular structure, the end part of the second electrode is provided with an outer convex arc surface, and the end opening edge of the outer arc surface is in smooth transition with the inner side surface of the second electrode through an inner convex arc surface.

The convex front section of the first electrode is embedded into the inner hole at the end part of the second electrode.

The first electrode and the second electrode are of hollow tubular structures, the opposite ends of the two electrodes are respectively provided with an outer arc surface which protrudes outwards, the end opening edge of the outer arc surface in the axial direction is in smooth transition with the inner side surface of the electrode through the inner arc surface which protrudes outwards, and the projection height of the outer arc surface in the axial direction is larger than or equal to the projection height of the inner arc surface in the axial direction.

The first electrode and the second electrode alternately extend spirally around the axis of the same cylindrical space, and the cross section of the electrode is circular, elliptical or annular.

The first electrode and the second electrode are embedded on the outer wall of the insulating tube, and the spiral bulge on the outer wall of the insulating tube forms an insulating layer between the opposite ends of the first electrode and the second electrode.

A pulse ablation catheter comprises a catheter tube body and the pulse ablation electrode assembly, wherein the catheter tube body is a controllable bent tube, the electrode assembly is fixed at the front end of the catheter tube body, a first electrode, a second electrode and the catheter tube body are coaxially arranged, and conducting wires of the first electrode and the second electrode are led out from a central hole of the catheter tube body.

And a mapping electrode is arranged on the outer side surface of the front section of the catheter body.

The ablation handle comprises a front handle and a rear handle body which can slide relatively in the axial direction, a groove and/or a flange is arranged on the front handle, a groove and/or a flange is arranged on the rear handle body, an axial through hole is arranged on the front handle and is communicated with an inner hole on the rear handle body, the tail end of the catheter tube body is fixed with the port of the axial through hole, one or more pull wires axially extend along the catheter tube body in the catheter tube body, the pull wires are fixed on the inner wall of the catheter tube body or an electrode in a mode of deviating from a central line at the far end so as to be capable of applying bending moment, and the pull wires penetrate through the central hole of the front handle and are fixed in the inner hole of the rear handle body at the near end.

Adopt above-mentioned scheme, beneficial effect is as follows, the end in opposite directions of two electrodes is the arch of shrinking gradually, the distance between the axial corresponding point on the end surface in opposite directions of two electrodes increases gradually, the end in opposite directions of first electrode and second electrode forms cyclic annular or heliciform recess, cyclic annular or heliciform recess is big end structure, the width of annular recess outwards crescent, opposite polarity's first electrode and second electrode can form pulse electric field, form enough intensity in whole electrode outside, the pulse electric field that the space is enough big, the electric field that produces in the end in opposite directions of two electrodes then is greater than the electric field of demand intensity, the electric field that is greater than demand intensity is in the recess. When electrode subassembly is to melting the operation, electrode subassembly effect is in human tissue's inner chamber inside wall or inner chamber lateral wall, the electrode is ablated on the tissue face, the direct and human tissue contact of surface of electrode, the mouth of recess is along contacting with human tissue, the electrode subassembly volume that can intervene human heart or other tissues under the ordinary condition is less, it is enough little to need electrode radial dimension in actual clinic, so that directly get into the focus of human tissue through blood vessel or other cavitys, the volume of recess is less relative human tissue volume, the local plane of human tissue or curved surface part can't get into annular groove inside, in whole ablation process, the electric field that is greater than the demand strength that two electrodes produced can't directly act on human tissue, human tissue's excessive damage and strong stimulation have been avoided. The general tissue fluid or blood can be because of the bubble appears in higher electric field intensity, sets up the insulating layer, and the electric field that is greater than the required intensity that two electrodes produced can not make the insulating layer appear the bubble in isolated regional, and the insulating layer sets up in the annular groove, can not lead to the external diameter grow of whole electrode subassembly. By adopting the utility model, not only can the enough large effective electric field space and the enough ablation depth be ensured, but also the pulse electric field exceeding the required intensity can be shielded; the present invention may be installed in a variety of existing interventional devices, for example, the present invention may be installed in the front end, side wall of a catheter mechanism of an existing radio frequency ablation assembly or in the front end or side wall of a variety of endoscopes, and the electrode assembly is delivered to lesion tissue for pulse ablation by existing interventional techniques.

The utility model is further described with reference to the following figures and specific examples.

Drawings

FIG. 1 is a schematic view of a pulse ablation electrode assembly and catheter having electrodes of spherical configuration;

FIG. 2 is an enlarged view of FIG. 1 at A;

FIG. 3 is a cross-sectional view of FIG. 2;

FIG. 4 is a schematic diagram of the pulse electric field distribution of FIG. 2;

FIG. 5 is a schematic structural view of a catheter having a pulsatile ablation electrode assembly with two tubular electrodes;

FIG. 6 is an enlarged view of FIG. 5 at B;

FIG. 7 is a cross-sectional view of FIG. 6;

FIG. 8 is a schematic diagram of the pulse electric field distribution of FIG. 5;

FIG. 9 is a schematic view of a spirally extended electrode and insulating tube arrangement;

FIG. 10 is a cross-sectional structural view of FIG. 9;

fig. 11 is a schematic diagram of the pulse electric field distribution in fig. 9.

In the drawing, 10 is a protrusion, 20 is an outer arc surface, 30 is an inner arc surface, 100 is a first electrode, 200 is a second electrode, 300 is an insulating column, 310 is an insulating layer, 320 is a connecting convex part, 400 is a catheter tube body, 410 is a lead wire, 420 is a mapping electrode, 500 is an ablation handle, 510 is a front handle, 520 is a rear handle body, 530 is a flange, 540 is a pull wire, 600 is a central guide wire, and 700 is an insulating tube.

Detailed Description

Specific embodiments of the present invention will be described in detail with reference to the accompanying drawings.

Referring to fig. 1 to 4, a first embodiment of a pulse ablation electrode assembly, which includes a first electrode 100 and a second electrode 200, the opposite ends of the two electrodes are respectively a gradually contracting protrusion 10, the surface of the protrusion is an arc surface, so as to ensure that the end of the whole electrode can be smoothly transited, avoid a tip effect, and the arc surface can be a positive curvature surface. The surface of the protrusion 10 can be a rotating curved surface, the rotating bus of the rotating curved surface is a convex curve, the slope of the convex curve section corresponding to the curved surface of the outer side surface of the electrode in smooth transition to the top end of the protrusion gradually increases, and the arc surface of the protrusion with the contraction effect is ensured. Further, the surface of the protrusion 10 may be a spherical crown surface, an ellipsoidal crown surface, or a paraboloid surface, and the surface of the protrusion 10 has no sharp structure of the tip, so that there is no point discharge caused by the tip effect, and there is no ionization and vaporization, bubble crusting, and strong muscle stimulation of the muscle and blood. An insulating layer 310 is provided between the facing ends of the two electrodes.

Referring to fig. 3, the first electrode 100 is a sphere structure, and the radius of the sphere is R₃Said R is₃Is 1mm-10mm, and the size of the ball head can meet the requirement of interventional ablation. The spherical structure is not easy to generate point discharge, meanwhile, the whole spherical structure is convenient to pass through human tissues, the passing resistance is reduced, the external electric field of the exposed part of the first electrode 100 is uniformly distributed, the first electrode 100 forms a pulse electric field uniformly surrounding the spherical surface on the side opposite to the second electrode 200, the specific surface of the electrode is not required to be subjected to ablation operation in the whole ablation process, and any angle can meet the requirement; the first electrode 100 of the protrusion 10 of the first electrode 100 is a spherical crown surface. The second electrode 200 is a hollow tubular structure, and the outer diameter of the second electrode 200 is R₁The inner diameter of the second electrode 200 is R₂(ii) a If R is₂、 R₁Satisfy R₂≤R₃≤R₁The spatial arrangement structure is more reasonable; the axial distance from the center of the sphere of the first electrode 100 to the top end of the second electrode 200 can be L₁Wherein L is₁≤2R₃. The end of the second electrode 200 is provided with a convex outer arc surface 20, and the outer side surface of the electrode passes throughThe outer arc surface is transited to the top end of the protrusion to ensure the contraction effect of the protrusion, the outer arc surface 20 can be a curved surface formed by rotating an arc curve, and the outer edge of the outer arc surface 20 is transited smoothly with the inner side surface of the second electrode 200 through the convex inner arc surface 30; in the embodiment, the rotating generatrices of the outer arc surface and the inner arc surface are in a common circle, the outer arc surface and the inner arc surface form a semi-arc curve, and the diameter of the semi-arc is the wall thickness of the second electrode; of course, the outer arcuate surface 20 may also be a spherical surface.

The insulating layer 310 may be annular, and the insulating layer 310 is made of insulating materials such as polytetrafluoroethylene, fluorinated ethylene propylene copolymer, thermoplastic elastomer rubber, and polyamide material. Two sides of the insulating layer 310 are respectively connected and fixed with the first electrode 100 and the second electrode 200. The insulating layer 310 can serve as an insulator and can stabilize the relative positions of the two electrodes. Referring to fig. 3, the front section of the second electrode 200 is provided with an insulating column 300, the major diameter of the insulating column 300 does not exceed the major diameter of any electrode, one end of the insulating column 300 is provided with a connecting convex part 320 to be embedded and fixed with the inner hole of the end part of the second electrode, and one end of the insulating column 300 facing the ball-head electrode is provided with a ball socket for fixing the first electrode 100. Of course, the two ends of the insulating column 300 can be fixed to the electrodes by using the conventional connection techniques such as embedding, welding or bonding. Wherein the shaft portion of the insulating column 300 on the insulator between the ends of the first electrode 100 and the second electrode 200 forms an insulating layer 310 that separates the first electrode 100 from the second electrode 200.

Further, when L is₁＜R₃The front section of the protrusion 10 of the first electrode 100 is embedded into the inner hole of the end of the second electrode 200, and the distance between the two electrodes can be reduced by adopting the structure, so that a pulse electric field with higher electric field intensity can be generated by using lower voltage, and the phenomena of strong ionization, discharge, strong muscle stimulation and the like caused by larger pulse voltage are avoided; meanwhile, the first electrode 100 with the spherical structure can be well supported centripetally by adopting the structure, and when the ball head end of the electrode is pressed on tissues during ablation operation, the electrode can provide large supporting force, so that the first electrode 100 and the second electrode 200 can be well supportedThe position accuracy. Thereby preventing the effective electric field shape from being largely deformed.

Referring to fig. 4, when a 1000V pulsed electric field is applied to the two electrodes, the effective electric field range covers the entire exposed surface of the first electrode 100, an electric field with a strength greater than that required is generated between the protrusions of the two electrodes, the pulsed electric field does not contact human tissue, and since the spherical crown surface is embedded into the end of the hollow tubular electrode, the spatial position of a part of the strongest pulsed electric field in the entire pulsed electric field moves inward, i.e., moves toward the axis and the inner cavity of the hollow tubular electrode, so that the possibility that the tissue surface with a larger curvature invades into the annular groove and is damaged can be further avoided, and the phenomena of scabbing, scorching and the like can be prevented.

Referring to fig. 5-8, a second embodiment of a pulse ablation electrode assembly, which differs from the first embodiment, the first electrode 100 and the second electrode 200 are both hollow tubular structures, the outer diameter of the hollow tubular structure is R1, the inner diameter of the hollow tubular structure is R2, the first electrode 100 and the second electrode 200 are coaxially arranged, the distance between the first electrode 100 and the second electrode 200 is 0.5-6mm, the opposite ends of the two electrodes are respectively provided with an outer convex arc surface 20, the outer arc surface 20 can be a curved surface formed by rotating an arc curve, the outer side surface of the electrode is transited to the top end of a bulge through the outer arc surface, so that the bulge forms a contraction effect, and further, the curved surface can be a spherical belt surface, the end opening edge of the outer arc surface 20 is in smooth transition with the inner side surface of the electrode through the outer convex inner arc surface 30, the projection height of the outer arc surface 20 along the axial direction is greater than or equal to the projection height of the inner arc surface along the axial direction. When the outer arc surface 20 is close to the thickness of the electrode wall, the curvature of the arc surface of the outer edge of the outer arc surface 20 is smooth and transited so as to avoid generating point discharge. In this embodiment, not only can the ablation be performed according to a desired path by using a common bendable catheter, but also the ablation can be performed by matching with guide wire guidance, the matched central guide wire 600 passes through the center of the catheter, when the catheter is used for pulse ablation, the ablation path is firstly laid through the central guide wire 600, the central guide wire 600 passes through the central hole of the electrode assembly, and then the catheter moves along the central guide wire 600 by the guidance of the central guide wire 600, so that the pulse ablation on the desired path is realized.

Referring to fig. 8, when a 1000V pulse electric field is applied to the two electrodes, the effective electric field range can cover the exposed surfaces of the first electrode and the second electrode, a pulse electric field with a strength greater than the required strength is generated between the two protrusions, the electric field is not in contact with human tissues, and an effective electric field is generated in the space outside the two electrodes, so that risks of hydrolysis, gasification, scabbing and the like of blood tissues can be avoided.

Referring to fig. 9 to 11, a third embodiment of a pulse ablation electrode assembly includes first and

second electrodes

100 and 200, the first and

second electrodes

100 and 200 alternately extend spirally around the axis of the same cylindrical space, the cross section of the electrode is circular, elliptical or annular, and the distance between the first and

second electrodes

100 and 200 may be smaller than the diameter of the electrode. The cross section of the electrode can be circular, oval or annular, in the alternative extension structure, the opposite ends of two electrodes form the arch 10 that shrinks gradually, bellied surface is the arcwall face, sets up insulating layer 310 between the opposite ends of two electrodes, sets up insulating layer 310 and can prevent to produce defects such as bubble in the electric field space of opposite ends in opposite ends, and helical structure also can increase electrode assembly's pliability again. The first electrode 100 and the second electrode 200 can be embedded in the outer wall of the insulating tube, the spiral protrusion of the outer wall of the insulating tube forms an insulating layer 310 between the opposite ends of the first electrode 100 and the second electrode 200, and the insulating tube can be sleeved on the catheter; or directly selecting an insulating pipe section of the catheter body, and embedding the two electrodes on the outer wall of the insulating pipe section.

Referring to fig. 11, when a voltage of 1000V is applied to the electrode assembly, an electric field space having a greater intensity than required is formed in the spiral groove between the electrodes without contacting the tissue, and an effective electric field is distributed outside the spiral structure, and this embodiment provides an effective electric field space around the cylindrical surface, by which linear ablation can be directly performed. In the actual treatment process, the voltage can be properly adjusted, the ablation requirement is met, and meanwhile, the electric field with the higher required intensity is distributed in the groove as much as possible, so that the tissue damage is reduced.

An embodiment of a pulse ablation catheter, referring to fig. 1 to 11, comprises a catheter tube 400 and the above-mentioned electrode assembly, wherein the catheter tube 400 is a controllable bent tube, the measurement unit of the catheter tube is Fr, the specification of the catheter tube is 6-20Fr, the above-mentioned electrode assembly is fixed at the front end of the catheter tube 400, the first electrode 100, the second electrode 200 and the catheter tube 400 are coaxially arranged, and the lead wires 410 of the first electrode 100 and the second electrode 200 are led out from the central hole of the catheter tube 400.

Further, a mapping electrode 420 is disposed on the outer side of the anterior segment of the catheter shaft 400. Electrical signals generated by a particular location of the heart are acquired by the locally positioned mapping electrodes 420, and the mapping electrodes 420 then transmit the acquired electrical signals to the corresponding examination device. The outside of the catheter shaft 400 is provided with a magnetic induction coil for three-dimensional magnetic positioning. The front end of the catheter body is provided with a pressure sensor for monitoring the pressure of the catheter in contact with the tissue. The ablation catheter may also include a temperature sensor for monitoring tissue temperature. For the control of the motion mode of the catheter, the bending section of the front end of the catheter tube 400 can be a smart material extending along the bending section trend, wherein the smart material is suitable for changing the spatial configuration of the bending section according to the external stimulation so as to change the bending degree of the bending section. The smart material may be made of a shape memory alloy and/or an electroactive polymer, the smart material may be in the form of a wire, and the smart material may be embedded in the wall of the catheter shaft. The intelligent material is selectively stimulated through resistance heating or electrical stimulation to deform, so that the catheter tube body is in a desired bent shape. Of course, the front section of the catheter tube body can also be provided with a magnet for receiving magnetic operation to realize the control of the deformation of the catheter tube body, the magnet is navigated and controlled through a magnetic navigation device, the catheter tube body is guided to deform or move, the magnetically operated catheter tube body realizes very accurate operation, and the risk of tissue trauma is reduced. Control of the manner of movement of the catheter shaft is not limited to that described above, and one or more pull wires 540 may be provided within the catheter shaft extending axially along the catheter shaft, with the lead wire 410 being off-center at the distal end and secured to the electrode assembly or the inner wall of the forward section of the catheter shaft 400, with bend control of the bend by tightening or loosening the lead wire 410, and at the proximal end, which may be mounted to a steering mechanism in the catheter handle. When the catheter is used for pulse ablation, the catheter tube body 400 is conveyed to the position near the focal tissues by the sheath tube, the sheath tube can be in a certain radian, the catheter tube body 400 extends out in a certain angle or direction, then the catheter tube body 400 extends outwards, the catheter tube body 400 is controlled to move, an electrode assembly on the catheter tube body 400 moves according to a desired path, and therefore point-shaped ablation or linear ablation or even closed annular ablation is achieved.

The pulse ablation catheter is not limited to only the above-described embodiments, but also includes a catheter ablation handle 500, the ablation handle 500 includes a front handle 510 and a rear handle body 520 that are axially slidable relative to each other, the front handle 510 is provided with a groove and/or a flange 530, the rear handle body 520 is provided with a groove and/or a flange 530, the front handle 510 is provided with an axial through hole communicated with the inner hole of the rear handle body 520, the tail end of the catheter tube body 400 is fixed with the front section port of the axial through hole, one or more pull wires 540 extending axially along the catheter shaft 400 within the catheter shaft 400, at the distal end, pull wire 540 is fixed to the inner wall of catheter shaft 400, or electrode assembly, off-center from the centerline, to enable application of a bending moment, at the proximal end, pull wire 540 is secured through the central bore of front handle 510 into the internal bore of the rear handle body, and bending of the forward section of the catheter is accomplished by pull wire 540. The pull wire 540 is tensioned or loosened through the relative movement of the front handle 510 and the rear handle body 520, so that the installation of a preset arc is realized, the front handle 510 or the rear handle body 520 is clamped on two driving ends of an opposite movement device through grooves and/or flanges 530 of the front handle 510 and the rear handle body 520, the movement of the two driving ends is controlled, the traction of the movement of the front handle 510 and the movement of the rear handle body 520 as well as the mutual movement between the front handle 510 and the rear handle body 520 can be realized, the handles can be operated manually or automatically through a tractor, the repetitive work of an operator can be reduced, and the control accuracy is improved.

When the scheme is adopted for focal tissue ablation, the electrode assembly is delivered to focal tissue, pulse voltages with opposite polarities are connected to the two electrodes through leads respectively, a pulse electric field with enough strength is formed outside the whole electrode assembly, the electric field generated at the adjacent ends of the two electrodes is larger than the electric field with required strength, the electric field with the required strength is positioned in the groove, when the electrode assembly ablates, the electrodes usually act on the inner cavity inner side wall or the inner cavity outer side wall of the human tissue, the electrodes ablate on the tissue surface, the surface of the electrodes is directly contacted with the human tissue, the opening edge of the groove is contacted with the human tissue, the pulse electric field with the required strength generated by the two electrodes cannot directly act on the human tissue, and excessive damage and strong stimulation of the human tissue are avoided. Generally, liquid is easy to generate bubbles due to higher pulse electric field intensity, the insulating layer 310 is arranged, and the electric field generated by the two electrodes and having the intensity higher than the required intensity can not enable the bubbles to be generated in the area isolated by the insulating layer 310. Of course, during the so-called monopolar ablation treatment procedure, where the electrode assembly is combined with either the epicardial electrode or the body surface reference electrode, the electrode assembly may be energized with a polarity that is opposite to that of the electrode assembly to perform the pulse ablation; the electrode assembly can be used as an electrode of a radio frequency electrode and can also be used for radio frequency ablation, pulse ablation and radio frequency ablation can be realized, and by adopting the electrode assembly, when an effective electric field space which is large enough and an ablation depth which is enough are ensured, a pulse electric field which exceeds the required strength can be shielded; the utility model can be used for interventional therapy of arrhythmia, coronary heart disease and other tissue diseases such as lung, liver and the like.

Having thus described the basic principles and principal features of the utility model, and its advantages, it will be apparent to those skilled in the art that the utility model may be embodied in other specific forms without departing from the principles and principal features of the utility model. The present embodiments are therefore to be considered in all respects as illustrative and not restrictive, the scope of the utility model being indicated by the appended claims rather than by the foregoing description, and all changes which come within the meaning and range of equivalency of the claims are therefore intended to be embraced therein. Any reference sign in a claim should not be construed as limiting the claim concerned.

Claims

1. A pulse ablation electrode assembly, comprising: the electrode comprises a first electrode (100) and a second electrode (200), wherein opposite ends of the two electrodes are both gradually contracted bulges (10), the surfaces of the bulges are arc-shaped surfaces, and an insulating layer (310) is arranged between the opposite ends of the two electrodes.

2. The pulse ablation electrode assembly of claim 1, wherein: the surface of the protrusion (10) is a rotating curved surface, and a rotating generatrix of the rotating curved surface is a convex curve.

3. A pulse ablation electrode assembly according to claim 1 or 2, wherein: the electrode structure is characterized in that the first electrode (100) is of a sphere structure, the surface of a protrusion (10) of the first electrode (100) is a spherical crown surface, the second electrode (200) is of a hollow tubular structure, an outer convex arc surface (20) is arranged at the end part of the second electrode (200), and the end opening of the outer arc surface (20) is in smooth transition with the inner side surface of the second electrode (200) through an inner convex arc surface (30).

4. The pulse ablation electrode assembly of claim 3, wherein: the front section of the bulge (10) of the first electrode (100) is embedded into the inner hole of the end part of the second electrode (200).

5. A pulse ablation electrode assembly according to claim 1 or 2, wherein: the first electrode (100) and the second electrode (200) are of hollow tubular structures, the opposite ends of the two electrodes are respectively provided with an outer convex arc surface (20), the end opening of the outer arc surface (20) in the axial direction is in smooth transition with the inner side surface of the electrode through an inner convex arc surface (30), and the projection height of the outer arc surface (20) in the axial direction is larger than or equal to the projection height of the inner arc surface in the axial direction.

6. The pulse ablation electrode assembly of claim 1, wherein: the first electrode and the second electrode alternately extend spirally around the axis of the same cylindrical space, and the cross section of the electrode is circular, elliptical or annular.

7. The pulse ablation electrode assembly of claim 6, wherein: the first electrode and the second electrode are embedded on the outer wall of the insulating tube, and the spiral bulge on the outer wall of the insulating tube forms an insulating layer between the opposite ends of the first electrode and the second electrode.

8. A pulse ablation catheter characterized by: the pulse ablation electrode assembly comprises a catheter tube body (400) and the pulse ablation electrode assembly of any one of claims 1 to 7, wherein the catheter tube body (400) is a controllable bent tube, the electrode assembly is fixed at the front end of the catheter tube body (400), the first electrode (100), the second electrode (200) and the catheter tube body (400) are coaxially arranged, and conducting wires (410) of the first electrode (100) and the second electrode (200) are led out from a central hole of the catheter tube body (400).

9. The pulse ablation catheter of claim 8, wherein: the outer side surface of the front section of the catheter tube body (400) is provided with a mapping electrode (420).

10. The pulse ablation catheter according to any one of claims 8 or 9, wherein: further comprising an ablation handle (500), the ablation handle (500) comprising a front handle (510) and a rear handle body (520) which are relatively slidable in the axial direction, the front handle (510) is provided with a groove and/or a flange (530), the rear handle body (520) is provided with a groove and/or a flange (530), the front handle (510) is provided with an axial through hole which is communicated with an inner hole on the rear handle body (520), the tail end of the catheter tube body (400) is fixed with the port of the axial through hole, one or more pull wires (540) axially extend along the catheter tube body (400) in the catheter tube body (400), at the distal end, a pull wire (540) is fixed to the inner wall of the catheter shaft (400) or to the electrode, offset from the centerline, to enable application of a bending moment, at the proximal end, the pull wire (540) is secured through the central bore of the front handle (510) into the internal bore of the rear handle body.