Pulse ablation catheter

Abstract

A pulse ablation catheter, comprising a first catheter (1) and an ablation assembly. The ablation assembly comprises an insulating film (21) and electrodes (22). By mounting the ablation assembly at a distal end of the first catheter (1), when the ablation assembly approaches a pulmonary vein antrum or a pulmonary vein ostium, the insulating film (21) pushes blood around the insulating film (21) until one end of each electrode (22) directly abuts against the pulmonary vein antrum or the pulmonary vein ostium, the insulating film (21) separates the pulmonary vein antrum or the pulmonary vein ostium from an atrium, and then ablation is started. In the ablation process, since the electrodes (22) are mounted on the outer wall surface of the insulating film (21), the blood at the pulmonary vein antrum or the pulmonary vein ostium does not come into contact with the other end of each electrode (22), and the blood in the atrium does not come into contact with the other end of each electrode (22). Thus, energy loss caused by transmitting energy into blood is reduced, low-voltage ablation is achieved, and myokymia and gas microbubbles caused by using high pulse voltage are reduced, making a surgery safer.

Description

A pulsed ablation catheter Technical Field

[0001] The present invention relates to the technical field of medical devices, and in particular to a pulse ablation catheter. Background Art

[0002] Atrial fibrillation (AF) is one of the most common arrhythmias in clinical practice. It is characterized by the loss of orderly electrical activity in the atria under the control of sinus rhythm, which is replaced by rapid and disordered fibrillation waves. As a result, the atria lose effective contraction and relaxation, and their pumping function deteriorates or is lost, leading to extremely irregular ventricular responses. It is one of the main causes of sudden cardiac death. Effective treatments for atrial fibrillation are all aimed at restoring sinus rhythm, and are mainly divided into two categories: drug therapy and non-drug therapy. Drug therapy is mainly suitable for patients with first-time atrial fibrillation and paroxysmal atrial fibrillation who have no relevant contraindications. Drug therapy can control ventricular rhythm and ensure basic heart function, such as beta-blockers, amiodarone, digitalis, etc. Non-drug treatments mainly include anticoagulation therapy, electrical cardioversion, surgical maze surgery, and catheter ablation.

[0003] Existing catheter ablation technologies often include radiofrequency ablation, cryoablation and pulse ablation. Among them, pulse ablation technology is an irreversible electroporation technology that generates a local electric field through direct current in the form of pulses. The local electric field affects the permeability of the lipid bilayer of the cell membrane, thereby inducing the formation of nanoscale defects or pores, thereby increasing the permeability of the cell. The traditional pulse ablation catheter includes a catheter, a ring electrode, a wire, a spline and a connector. Among them, the catheter is provided with a branch, and the electrode ring is fixedly installed at the branch and electrically connected to the connector through a wire. When the electric pulse passes through the electrode ring, the electric field forms an ablation electric field on the surface of the electrode ring from the positive pole to the negative pole, and the energy emission diverges toward the surroundings along the radial direction of the electrode. At the same time, the electrode ring is set to be composed of two parts, one part of the electrode ring contacts the pulmonary vein vestibule or the pulmonary vein orifice in the atrium for ablation, and the other part of the electrode ring contacts the blood.

[0004] However, since part of the electrode is in contact with the blood, when ablation is performed on the pulmonary vein vestibule or the pulmonary vein orifice in the atrium, the blood will disperse part of the ablation energy. At this time, the voltage of the electrode ring needs to be increased to normally ablate the vestibule or the pulmonary vein orifice. The high pulse voltage will produce tiny bubbles and blood clots in the blood. These tiny bubbles and blood clots will enter the brain blood vessels and cause invisible cerebral infarction. In addition, the high pulse voltage will also stimulate skeletal muscles and cause muscle tremors. At this time, general anesthesia surgery is required, resulting in insufficient practicality of the pulse ablation catheter.

[0005] Summary of the Invention

[0006] Therefore, the technical problem to be solved by the present invention is that in the existing technology, since a part of the electrode is in contact with the blood, the voltage of the electrode ring needs to be increased in order to ablate the atrial wall normally. However, the high pulse voltage will produce tiny bubbles, thrombi, muscle fibrillation and other phenomena, resulting in insufficient practicality of the pulse ablation catheter.

[0007] To this end, the present invention provides a pulse ablation catheter, comprising:

[0008] a first conduit, the first conduit having a proximal end disposed close to an external handle and a distal end disposed away from the proximal end;

[0009] An ablation component is installed at the distal end. The ablation component includes an insulating film and an electrode. The electrode is directly or indirectly installed on the outer wall of the insulating film.

[0010] Optionally, the above-mentioned pulse ablation catheter further includes:

[0011] The second conduit is coaxially arranged with the first conduit and is located inside the first conduit.

[0012] Optionally, the above-mentioned pulse ablation catheter,

[0013] The second conduit rotates along the circumferential direction of the first conduit;

[0014] The ablation component also includes multiple groups of splines, and the ends of the multiple groups of splines away from the external handle are installed on the inner wall surface of the insulating film. The end of any spline close to the external handle is located inside the first catheter along the radial direction of the first catheter.

[0015] Optionally, the above-mentioned pulse ablation catheter,

[0016] It also includes a plurality of connecting parts, which are arranged corresponding to the splines, and the connecting parts are all sleeved on the outer wall surface of the splines, and the plurality of connecting parts are rotatably connected.

[0017] Optionally, the above-mentioned pulse ablation catheter,

[0018] The splines are provided in two groups, one group of splines encloses a receiving cavity, and the other group of splines is located in the receiving cavity;

[0019] There are two connecting members, one connecting member is provided with a first rotating part, and the other connecting member is provided with a second rotating part. In the first rotating part and the second rotating part, one of them is provided with a limiting protrusion, and the other of them is provided with a mounting groove, and the limiting protrusion is rotatably mounted in the mounting groove;

[0020] The external force acts directly or indirectly on one or both of the two connecting members to make the two groups of splines coplanar or cross-arranged, and the two groups of splines switch between the coplanar and cross-arranged settings.

[0021] Optionally, the above-mentioned pulse ablation catheter,

[0022] The spline includes a first connecting portion and a second connecting portion connected to the first connecting portion, wherein the first connecting portion is arranged close to the connecting member;

[0023] There are a plurality of electrodes, and the plurality of electrodes are respectively installed on the first connecting portion and the second connecting portion.

[0024] Optionally, in the above-mentioned pulse ablation catheter, the second catheter moves inside the first catheter along the axis direction of the first catheter;

[0025] Also includes:

[0026] A fixing member, the fixing member is a columnar structure, and the fixing member is sleeved outside the second conduit;

[0027] A plurality of support members, each of which is made of a memory alloy, is located on a side of the first conduit away from the external handle, and is connected to the fixing member;

[0028] Wherein, under the action of external force, the second conduit moves along the axial direction of the first conduit toward the side close to the external handle, so that the side of the multiple support members close to the first conduit moves away from each other along the radial direction of the first conduit until the insulating film forms an umbrella-shaped structure.

[0029] Optionally, the above-mentioned pulse ablation catheter,

[0030] The fixing member is located outside the insulating film; or

[0031] The fixing piece is located inside the insulating film.

[0032] Optionally, the above-mentioned pulse ablation catheter further includes:

[0033] A flexible electrical connector, the flexible electrical connector being mounted on the outer wall of the insulating film;

[0034] The electrode is installed on a side of the flexible electrical connector away from the insulating film, and the electrical connector is electrically connected to an external power source via the flexible electrical connector and a wire.

[0035] Optionally, the above-mentioned pulse ablation catheter,

[0036] The electrode has a flat structure or a planar structure.

[0037] The technical solution provided by the present invention has the following advantages:

[0038] The pulse ablation catheter provided by the present invention comprises a first catheter and an ablation assembly. The first catheter has a proximal end disposed proximal to an external handle and a distal end disposed distal to the proximal end; the ablation assembly is mounted at the distal end and comprises an insulating film and electrodes, the electrodes being mounted directly or indirectly on the outer wall of the insulating film.

[0039] The pulse ablation catheter of this structure is installed at the distal end of the first catheter. When the ablation component is close to the pulmonary vein vestibule or the pulmonary vein orifice, the insulating film will push blood around it until one end of the electrode directly abuts the pulmonary vein vestibule or the pulmonary vein orifice. The insulating film separates the pulmonary vein vestibule or the pulmonary vein orifice from the interior of the atrium, and then ablation begins. During the ablation process, because the electrode is installed on the outer wall of the insulating film, the blood at the pulmonary vein vestibule or the pulmonary vein orifice will not contact the other end of the electrode due to the restriction of the insulating film, and the blood in the atrium will not contact the other end of the electrode. Compared with the existing solution that requires increasing the voltage of the electrode ring to achieve normal ablation, the pulse ablation catheter of this structure can reduce the energy lost by transmitting into the blood, reduce the voltage used for ablation, and achieve the purpose of ablation using a lower voltage, reduce muscle tremors and gas microbubbles caused by the use of high voltage, make the operation safer, and thus improve the practicality of the pulse ablation catheter. BRIEF DESCRIPTION OF THE DRAWINGS

[0040] In order to more clearly illustrate the embodiments of the present invention or the technical solutions in the prior art, the following briefly introduces the drawings required for use in the embodiments. Obviously, the drawings described below are only some embodiments of the present invention. For ordinary technicians in this field, other drawings can be obtained based on these drawings without paying any creative work.

[0041] FIG1 is a schematic top view of the structure of a pulse ablation catheter provided by an embodiment of the present invention, in which two sets of splines are arranged coplanarly in a first embodiment;

[0042] FIG2 is a schematic side view of the structure of the pulse ablation catheter provided by an embodiment of the present invention, in which two sets of splines are cross-arranged in the first embodiment;

[0043] FIG3 is a schematic structural diagram of the pulse ablation catheter provided by an embodiment of the present invention, which is a first embodiment and is located within a sheath and in a contracted state;

[0044] FIG4 is a schematic structural diagram of a pulse ablation catheter according to an embodiment of the present invention in a first embodiment, wherein the local structure is located inside the sheath and is in a transitional state;

[0045] FIG5 is a schematic structural diagram of the pulse ablation catheter provided by an embodiment of the present invention when the first embodiment is in contact with tissue;

[0046] FIG6 is a schematic structural diagram of the pulse ablation catheter provided by an embodiment of the present invention in the first embodiment when two connectors are in a separated state;

[0047] FIG7 is a cross-sectional view of section AA in FIG6 ;

[0048] FIG8 is a top view of a second embodiment of the pulse ablation catheter provided by an embodiment of the present invention;

[0049] FIG9 is a schematic structural diagram of a second embodiment of a pulse ablation catheter provided by an embodiment of the present invention, located within a sheath and in a contracted state;

[0050] FIG10 is a schematic structural diagram of a pulse ablation catheter according to an embodiment of the present invention, wherein the partial structure of the second embodiment is located inside the sheath and is in a transition state;

[0051] FIG11 is a schematic structural diagram of a second embodiment of a pulse ablation catheter provided by an embodiment of the present invention in an expanded state;

[0052] FIG12 is a front view of a pulse ablation catheter provided by an embodiment of the present invention, which is an extended embodiment of the second embodiment;

[0053] FIG13 is a side view of a pulse ablation catheter provided by an embodiment of the present invention, which is an extended embodiment of the second embodiment;

[0054] FIG14 is a schematic structural diagram of a pulse ablation catheter provided in an embodiment of the present invention, which is another extended embodiment of the second embodiment;

[0055] FIG15 is a schematic structural diagram of a third embodiment of a pulse ablation catheter provided by an embodiment of the present invention;

[0056] FIG16 is a schematic structural diagram of a third embodiment of a pulse ablation catheter provided by an embodiment of the present invention, located within a sheath and in a contracted state;

[0057] FIG17 is a schematic structural diagram of a pulse ablation catheter according to an embodiment of the present invention, wherein the partial structure of the third embodiment is located inside the sheath and is in a first stage transition state;

[0058] FIG18 is a schematic structural diagram of a pulse ablation catheter provided by an embodiment of the present invention in a third embodiment and in a transition state of the second stage;

[0059] FIG19 is a schematic structural diagram of a third embodiment of a pulse ablation catheter provided by an embodiment of the present invention in an expanded state;

[0060] FIG20 is a schematic structural diagram of a third embodiment of a pulse ablation catheter provided by an embodiment of the present invention;

[0061] FIG21 is a schematic cross-sectional view of section AA in FIG20 ;

[0062] FIG22 is a schematic structural diagram of a pulse ablation catheter according to a fourth embodiment of the present invention;

[0063] FIG23 is a schematic structural diagram of a pulse ablation catheter according to a fourth embodiment of the present invention, located within a sheath and in a contracted state;

[0064] FIG24 is a schematic structural diagram of a pulse ablation catheter according to an embodiment of the present invention, wherein the partial structure of the fourth embodiment is located inside the sheath and is in a first stage transition state;

[0065] FIG25 is a schematic structural diagram of the pulse ablation catheter provided by an embodiment of the present invention in the second stage transition state of the fourth embodiment;

[0066] FIG26 is a schematic structural diagram of a fourth embodiment of a pulse ablation catheter provided by an embodiment of the present invention in an expanded state;

[0067] FIG27 is a schematic structural diagram of a fourth embodiment of a pulse ablation catheter provided by an embodiment of the present invention;

[0068] FIG28 is a schematic cross-sectional view of section BB in FIG27 ;

[0069] FIG29 is a schematic structural diagram of the third or fourth embodiment of the pulse ablation catheter provided by an embodiment of the present invention in an expanded state and resting against the left pulmonary vein vestibule;

[0070] FIG30 is a schematic structural diagram of the third or fourth embodiment of the pulse ablation catheter provided by an embodiment of the present invention in an expanded state and abutting against the left upper pulmonary vein ostium;

[0071] FIG31 is a schematic structural diagram of the third or fourth embodiment of the pulse ablation catheter provided by an embodiment of the present invention in an expanded state and abutting against the right lower pulmonary vein ostium;

[0072] FIG32 is a schematic structural diagram of the fourth embodiment of the pulse ablation catheter provided by an embodiment of the present invention when located in the left upper pulmonary vein and in a transitional state;

[0073] FIG33 is a schematic structural diagram of the fourth embodiment of the pulse ablation catheter provided by an embodiment of the present invention, when located in the left lower pulmonary vein and in an expanded state.

[0074] Description of reference numerals:

[0075] 1. First catheter;

[0076] 21. Insulating film; 22. Electrode; 23. Spline; 231. First connecting portion; 232. Second connecting portion; 233. Third connecting portion; 24. Frame;

[0077] 3. Second catheter;

[0078] 4. Connecting member; 401. First rotating part; 402. Second rotating part;

[0079] 5. Fixing parts;

[0080] 6. Support parts;

[0081] 7. Flexible electrical connectors;

[0082] 8. Third catheter;

[0083] 91. Pulling piece; 92. Sheath. DETAILED DESCRIPTION

[0084] The following will clearly and completely describe the technical solutions in the embodiments of the present invention in conjunction with the accompanying drawings. Obviously, the described embodiments are only part of the embodiments of the present invention, not all of the embodiments. Based on the embodiments of the present invention, all other embodiments obtained by ordinary technicians in this field without making creative efforts are within the scope of protection of the present invention.

[0085] In the description of the present invention, it should be noted that the terms "center," "upper," "lower," "left," "right," "vertical," "horizontal," "inner," and "outer," etc., indicating orientations or positional relationships, are based on the orientations or positional relationships shown in the accompanying drawings and are intended solely to facilitate and simplify the description of the present invention. They are not intended to indicate or imply that the devices or components referred to must have, be constructed, or operate in a specific orientation, and therefore should not be construed as limitations on the present invention. Furthermore, the terms "first," "second," and "third" are used for descriptive purposes only and should not be construed as indicating or implying relative importance.

[0086] In the description of the present invention, it should be noted that, unless otherwise expressly specified or limited, the terms "mounted," "connected," and "connected" should be understood broadly. For example, they may refer to fixed, detachable, or integral connections; mechanical or electrical connections; direct or indirect connections through an intermediary; and internal communication between two components. Those skilled in the art will understand the specific meanings of these terms in the present invention based on the specific circumstances.

[0087] In addition, the technical features involved in the different embodiments of the present invention described below can be combined with each other as long as they do not conflict with each other.

[0088] Example 1

[0089] This embodiment provides a pulsed ablation catheter, as shown in Figures 1 to 33 , comprising a first catheter 1 and an ablation assembly. The first catheter 1 has a proximal end connected to an external handle and a distal end remote from the proximal end. The ablation assembly is mounted at the distal end and includes an insulating film 21 and an electrode 22 , which is mounted directly or indirectly on the outer surface of the insulating film 21 .

[0090] The pulse ablation catheter of the above structure is constructed by installing the ablation component at the distal end of the first catheter 1. When in use, when the ablation component is close to the pulmonary vein vestibule or the pulmonary vein orifice, the insulating film 21 will push blood around it until one end of the electrode 22 directly abuts the pulmonary vein vestibule or the pulmonary vein orifice. The insulating film 21 separates the pulmonary vein vestibule or the pulmonary vein orifice from the interior of the atrium, and then ablation begins. During the ablation process, since the electrode 22 is installed on the outer wall of the insulating film 21, the blood at the pulmonary vein vestibule or the pulmonary vein orifice and the blood in the atrium will not contact the other end of the electrode 22 due to the restriction of the insulating film 21. Compared with the existing solution, it is necessary to increase the voltage of the electrode ring to achieve normal ablation. The pulse ablation catheter of this structure can reduce the energy lost due to transmission into the blood, that is, reduce the arc generated in the blood during the ablation process, thereby reducing the formation of bubbles and microthrombi, and thus reducing the probability of invisible cerebral infarction, making the operation safer, that is, energy is effectively used for ablation to achieve low-voltage ablation, so that local anesthesia surgery is used instead of traditional general anesthesia surgery during the ablation process, thereby improving the practicality of the pulse ablation catheter.

[0091] As shown in Figures 1 to 33 , the pulse ablation catheter provided in this embodiment further includes a second catheter 3. Specifically, the second catheter 3 is coaxially arranged with the first catheter 1 and is located inside the first catheter 1.

[0092] It should be noted that the structure of the pulse ablation catheter provided in this embodiment is not limited, and the electrode 22 can be separated from the blood in the atrium and the blood in the pulmonary vein vestibule during ablation.

[0093] The pulse ablation catheter provided in this embodiment does not limit the form of relative movement between the first catheter 1 and the second catheter 3. Either the second catheter 3 or the first catheter 1 can move relative to the other along the axial direction, or either the second catheter 3 or the first catheter 1 can rotate relative to the other along the circumferential direction.

[0094] It can be explained that in the first implementation of the pulse ablation catheter provided in this embodiment, as shown in Figures 1 to 7, the second catheter 3 rotates along the circumferential direction of the first catheter 1; at this time, the ablation component also includes multiple groups of splines 23, and the ends of the multiple groups of splines 23 away from the external handle are installed on the inner wall surface of the insulating film 21, and the end of any spline 23 close to the external handle is located inside the first catheter 1 along the radial direction of the first catheter 1.

[0095] Specifically, the first pulse ablation catheter embodiment further includes a plurality of connectors 4 , which are arranged corresponding to the splines 23 , and are all sleeved on the outer wall of the splines 23 , and the plurality of connectors 4 are rotatably connected.

[0096] Specifically, in the first embodiment of the pulse ablation catheter, two groups of splines 23 are provided, one group of splines 23 encloses a receiving cavity, and the other group of splines 23 is located in the receiving cavity; at this time, two connecting members 4 are provided, one connecting member 4 is provided with a first rotating part 401, and the other connecting member 4 is provided with a second rotating part 402. In the first rotating part 401 and the second rotating part 402, one of them is provided with a limiting protrusion, and the other of them is provided with a mounting groove, and the limiting protrusion can be rotatably installed in the mounting groove; wherein, external force directly or indirectly acts on one or two of the two connecting members 4 to make the two groups of splines 23 coplanar, as shown in Figure 1; or the two groups of splines 23 are cross-arranged, as shown in Figure 2, and the two groups of splines 23 are switched between coplanar and cross settings.

[0097] Furthermore, in an embodiment of the first pulse ablation catheter, the spline 23 includes a first connecting portion 231 and a second connecting portion 232 connected to the first connecting portion 231, and the first connecting portion 231 is arranged close to the connecting member 4; there are multiple electrodes 22, and the multiple electrodes 22 are respectively installed on the first connecting portion 231 and the second connecting portion 232.

[0098] It should be noted that, when installing the electrodes 22 , the electrodes 22 installed on the second connecting portion 232 are arranged in an array; the electrodes 22 installed on the first connecting portion 231 can be arranged at intervals.

[0099] It should be noted that in the first embodiment of the pulse ablation catheter, the spline 23 also includes a third connection part 233, which is located on the side of the second connection part 232 away from the first connection part 231, and the third connection part 233 is arranged between the second connection part 232 and the distal end of the first catheter 1.

[0100] It should be noted that in the first embodiment of the pulse ablation catheter, the radial dimension of the second catheter 3 is smaller than the radial dimension of the first catheter 1, and the second catheter 3 is coaxially arranged with the first catheter 1 so that the first catheter 1 and the second catheter 3 form a cavity in the radial direction. At the same time, in the two sets of third connecting portions 233 in the two sets of splines 23, one set of third connecting portions 233, whose side near the distal end of the first catheter 1 is located within the cavity formed in the radial direction by the first and second catheters 1 and 3, and the other set of third connecting portions 233, whose side near the distal end of the first catheter 1 is located inside the second catheter 3, facilitates the relative rotation of the two sets of splines 23 when the second catheter 3 rotates circumferentially relative to the first catheter 1, thereby enabling the two sets of splines 23 to switch between a coplanar arrangement and a cross arrangement.

[0101] It should be noted that in the first embodiment of the pulse ablation catheter, the spline 23 is configured as a tubular structure, which can be a flat square tube or a cylindrical round tube, and the interior of the tubular structure is hollow for placing a wire electrically connected to the electrode 22.

[0102] It should be noted that, in the first embodiment of the pulse ablation catheter, the electrode 22 is embedded in the spline 23, which is conducive to the fit between the electrode 22 and the vestibule when the heart beats.

[0103] It should be noted that in the embodiment of the first pulse ablation catheter, the ablation catheter has a contracted state, a transitional state, and an expanded state. When the ablation catheter is in the contracted state, as shown in FIG3 , the first catheter 1, the insulating film 21, the electrode 22, and the spline 23 are all located inside the sheath 92; when the ablation catheter is in the transitional state, as shown in FIG4 , the first catheter 1 moves along its axial direction so that a portion of the insulating film 21, the electrode 22, and the spline 23 are still located inside the sheath 92; when the first catheter 1 moves along its axial direction and toward the side away from the external handle until all the insulating films 21, the electrodes 22, and the spline 23 are located outside the sheath 92, the ablation catheter is in the expanded state, and then the first catheter 1 and the second catheter 3 are rotated relative to each other as needed.

[0104] When the first type of pulse ablation catheter mentioned above is used, the sheath 92 is operated to enter the femoral veins at the groin on both sides, and then along the vein to the right atrium, and then the atrial septum is punctured to the left atrium to perform ablation at the pulmonary vein vestibule or the pulmonary vein orifice. Before ablation, the ablation catheter is moved from a contracted state in the sheath 92 along its axial direction and toward the side away from the external handle until a part of the insulating film 21, the electrode 22 and the spline 23 are separated from the sheath 92, at which time the ablation catheter is in a transition state; until the insulating film 21, the electrode 22 and the spline 23 in the ablation catheter are all separated from the sheath 92, so that the ablation catheter is in an expanded state; then the first catheter 1 and the second catheter 3 are rotated relative to each other as needed; finally, as shown in Figure 5, the ablation catheter is placed against the tissue to be ablated.

[0105] It can be explained that the second embodiment of the pulse ablation catheter provided in this embodiment, as shown in Figures 8 to 14, is compared with the first embodiment shown in Figures 1 to 7. The pulse ablation catheter provided in this embodiment includes a first catheter 1, an outer contour structure, an insulating film 21 and an electrode 22. At this time, the electrode 22 is still installed on the outer wall surface of the insulating film 21, and the outer contour structure is used to shape the electrode 22 and the insulating film 21 after installation. At this time, the wire of the electrode 22 extends to the inside of the first catheter 1.

[0106] Specifically, in the second embodiment of the pulse ablation catheter, the multiple electrodes 22 are arranged in a matrix, and a portion of each electrode 22 is inside the insulating film 21, and another portion of each electrode 22 is disposed through the insulating film 21 and in contact with the outside world.

[0107] Specifically, in the second embodiment of the pulse ablation catheter, the planar insulating film 21 with the electrode 22 can be attached to the tissue site that needs to be treated. During the attachment process, the insulating film 21 can displace the blood around it to prevent the blood from contacting the electrode 22; at the same time, the outer contour structure is made of a memory alloy material, such as nickel-titanium alloy or copper-based alloy, which has a certain toughness and elasticity. The shape of the outer contour structure can be changed by applying a thrust through the catheter to enable the electrode 22 to better adhere to the tissue site.

[0108] It should be noted that in the second embodiment of the pulse ablation catheter, the outer contour structure is a frame 24. At this time, the ablation catheter also has a contracted state, a transitional state, and an expanded state. When the ablation catheter is in the contracted state, as shown in Figure 9, the first catheter 1, the insulating film 21, the electrode 22, and the frame 24 are all located inside the sheath 92; when the ablation catheter is in the transitional state, as shown in Figure 10, the first catheter 1 moves along its axial direction so that a portion of the insulating film 21, the electrode 22, and the frame 24 are still located inside the sheath 92; when the first catheter 1 moves along its axial direction and toward the side away from the external handle until all the insulating film 21, the electrode 22, and the frame 24 are located outside the sheath 92, the ablation catheter is in the expanded state, as shown in Figure 11.

[0109] Furthermore, there is an extended embodiment of the second pulse ablation catheter. Among them, an extended embodiment of the second pulse ablation catheter is: as shown in Figures 12 and 13, the frame 24, the insulating film 21 and the electrode 22 are arranged in sequence, and at this time the frame 24 is an arc-shaped structure, so that the ablation catheter is better attached to the ablation tissue. Another extended embodiment of the second pulse ablation catheter is: as shown in Figure 14, on the basis of the embodiment of the second pulse ablation catheter, a pulling member 91 is added. At this time, the pulling member 91 can be selected as a steel wire, one end of the steel wire is connected to the end of the frame 24 away from the external handle, and the other end of the steel wire extends into the first catheter 1 and is connected to the external handle, so that the doctor can adjust the degree of bending of the frame 24 by controlling the length of the steel wire.

[0110] When the second type of pulse ablation catheter is used, the sheath 92 is operated to enter the femoral veins at the groin on both sides, and then the catheter is guided along the veins to the right atrium, and then the atrial septum is punctured to the left atrium to perform ablation at the pulmonary vein vestibule or the pulmonary vein orifice. Before ablation, the ablation catheter is moved from a contracted state to a side away from the external handle in the sheath along its axis until a portion of the insulating film 21, the electrode 22 and the frame 24 are separated from the sheath 92. At this time, the ablation catheter is in a transitional state; until the insulating film 21, the electrode 22 and the frame 24 in the ablation catheter are all separated from the sheath 92, so that the ablation catheter is in an expanded state; and then the ablation catheter is placed against the tissue to be ablated.

[0111] It can be explained that in the third implementation of the pulse ablation catheter provided in this embodiment, as shown in Figures 15 to 21, the second catheter 3 moves inside the first catheter 1 along the axial direction of the first catheter 1; at this time, the pulse ablation catheter also includes a fixing part 5 and multiple support parts 6, the fixing part 5 is a columnar structure, and the fixing part 5 is sleeved on the outside of the second catheter 3; the support parts 6 are all made of memory alloy material, such as nickel-titanium alloy, and at this time, the multiple support parts 6 are all located on the side of the first catheter 1 away from the external handle, and the support parts 6 are all connected to the fixing part 5. Among them, the second conduit 3 can move along the axial direction of the first conduit 1 under the action of external force. During the movement, the second conduit 3 can drive the fixing part 5 to move, and the fixing part 5 drives the support part 6 to change its shape, such as the second conduit 3 moves along the axial direction of the first conduit 1 toward the side close to the external handle, so that the multiple support parts 6 close to the side of the first conduit 1 move away from each other along the radial direction of the first conduit 1 until the insulating film 21 forms an umbrella-shaped structure; or the second conduit 3 moves along the axial direction of the first conduit 1 away from the side of the external handle under the action of external force, so that the multiple support parts 6 close to the side of the first conduit 1 move toward each other along the radial direction of the first conduit 1 for easy storage.

[0112] Specifically, in this embodiment, the fixing member 5 is located outside the insulating film 21 .

[0113] It should be noted that in the third embodiment of the pulse ablation catheter, the ablation catheter also has a contracted state, a transition state, and an expanded state. When the ablation catheter is in the contracted state, as shown in FIG16 , the first catheter 1, the insulating film 21, the electrode 22, the fixing member 5, the support member 6, the flexible electrical connector 7, and the third catheter 8 are all located inside the sheath 92; the transition state of the third pulse ablation catheter has two stages. In the first stage, as shown in FIG17 , the first catheter 1 moves along its axial direction, so that the fixing member 5, the insulating film 21, the electrode 22, and a portion of the third catheter 8 are still located outside the sheath 92. In the second stage, as shown in FIG18 , the first catheter 1, the insulating film 21, the electrode 22, the fixing member 5, and the flexible electrical connector 7 are completely located outside the sheath 92; then the ablation catheter is moved to the site to be ablated, and the second catheter 3 is pulled back, so that the ablation catheter is in the expanded state, as shown in FIG19 .

[0114] Furthermore, the contraction state of the third embodiment of the pulse ablation catheter is further explained. As shown in Figures 20 and 21, when the pulse catheter is in the contraction state, the insulating film 21 between the two adjacent support members 6 is concave toward one side of the second catheter 3.

[0115] It can be explained that the fourth embodiment of the pulse ablation catheter provided in this embodiment is different from the third embodiment, as shown in Figures 22 to 28, only in that the fixing part 5 is located inside the insulating film 21, and at this time each support part 6 is bent toward the side close to the external handle.

[0116] It should be noted that in the fourth embodiment of the pulse ablation catheter, the ablation catheter also has a contracted state, a transition state, and an expanded state. When the ablation catheter is in the contracted state, as shown in FIG23 , the first catheter 1, the insulating film 21, the electrode 22, the fixing member 5, the support member 6, the flexible electrical connector 7, and the third catheter 8 are all located inside the sheath 92; the transition state of the fourth pulse ablation catheter has two stages. In the first stage, as shown in FIG24 , the first catheter 1 moves along its axial direction, so that the fixing member 5, the insulating film 21, the electrode 22, and a portion of the third catheter 8 are still located outside the sheath 92. In the second stage, as shown in FIG25 , the first catheter 1, the insulating film 21, the electrode 22, the fixing member 5, and the flexible electrical connector 7 are completely located outside the sheath 92; then the ablation catheter is moved to the site to be ablated, and the second catheter 3 is pulled back, so that the ablation catheter is in the expanded state, as shown in FIG26 .

[0117] Similarly, the insulating film 21 in the fourth embodiment of the pulse ablation catheter has the same structure as the insulating film 21 in the third embodiment of the pulse ablation catheter when it is in a contracted state, that is, as shown in Figures 27 and 28, when the pulse catheter is in a contracted state, the insulating film 21 between the two adjacent support members 6 is concave toward the side of the second catheter 3.

[0118] Furthermore, in the above-mentioned third embodiment of the pulse ablation catheter and the fourth embodiment of the pulse ablation catheter, the portion of the fixing member 5 close to the insulating film 21 is not coated to ensure normal blood circulation between the pulmonary vein and the atrium. At this time, since the insulating film 21 will drain the blood during movement, until the electrode 22 is attached to the tissue to be ablated, the electrode 22 arranged outside the insulating film 21 is separated from the blood circulating inside the insulating film 21, which can also reduce the arc generated in the blood during the ablation process, thereby reducing the formation of bubbles and microthrombi, and thus reducing the probability of invisible cerebral infarction, making the operation safer, that is, energy is effectively used for ablation, achieving low-voltage ablation, and thus using local anesthesia surgery instead of traditional general anesthesia surgery during the ablation process, thereby improving the practicality of the pulse ablation catheter; at the same time, the outer surface of the support member 6 is coated with an insulating coating, or is provided with an insulating protective tube, such as a heat shrink tubing.

[0119] In the above-mentioned third embodiment of the pulse ablation catheter and the fourth embodiment of the pulse ablation catheter, the second catheter 3 is moved along the axial direction of the first catheter 1 toward the side close to the external handle under the action of external force, so that the side of the multiple support members 6 close to the first catheter 1 moves away from each other along the radial direction of the first catheter 1 until the insulating film 21 is in an umbrella-shaped structure, so that when the insulating film 21 is attached to the vestibule, blood can flow between the pulmonary veins and the atrium. At the same time, by attaching the electrode 22 to the vestibule and providing an insulating film 21, the blood is separated from the electrode 22, which can reduce the energy transmitted into the blood, so that the energy is effectively used for ablation and low-voltage ablation is achieved.

[0120] It should be noted that, as shown in Figures 1 to 33 , the third and fourth pulse ablation catheter embodiments further include a flexible electrical connector 7. The flexible electrical connector 7 is mounted on the outer wall of the insulating film 21; the electrode 22 is mounted on the side of the flexible electrical connector 7 away from the insulating film 21; and the electrical connector 4 is electrically connected to an external power source via the flexible electrical connector 7 and a wire.

[0121] It should be noted that the third embodiment of the pulse ablation catheter and the fourth embodiment of the pulse ablation catheter further include a third catheter 8 . In this case, the interior of the third catheter 8 is hollow and is used to place the wires of the electrode 22 and the support 6 .

[0122] It should be noted that in the above-mentioned third embodiment of the pulse ablation catheter and the fourth embodiment of the pulse ablation catheter, the structure of the insulating film 21 is not limited. The insulating film 21 can be made of pericardium. Of course, in other optional embodiments, the insulating film 21 can also be made of polymer materials, such as polyethylene or TPU.

[0123] It should be noted that, in the above-mentioned third embodiment of the pulse ablation catheter and the fourth embodiment of the pulse ablation catheter, the structural schematic diagram of the pulse ablation catheter when it is abutted against the left pulmonary vein vestibule is shown in Figure 29; the structural schematic diagram of the pulse ablation catheter when it is abutted against the left upper pulmonary vein orifice is shown in Figure 30; the structural schematic diagram of the pulse ablation catheter when it is abutted against the right lower pulmonary vein orifice is shown in Figure 31; the structural schematic diagram of the pulse ablation catheter when it is in a transition state at the left upper pulmonary vein orifice is shown in Figure 32; the structural schematic diagram of the pulse ablation catheter when it is in an expanded state at the left upper pulmonary vein orifice is shown in Figure 32.

[0124] It can be explained that, in the above four embodiments of the pulse ablation catheter, the structure of the electrode 22 is not limited, and the electrode 22 can be a flat structure, a planar structure, or a circular structure.

[0125] It can be explained that in the above-mentioned four embodiments of the pulse ablation catheter, a developing ring is also included. In this case, the developing ring is installed at the distal end of the first catheter 1, such as the connector 4 in Figure 1, or the fixing part 5 in Figures 15 and 22; at the same time, the electrode 22 can be made of gold or platinum-iridium alloy, which can realize the developing function under radiation.

[0126] It should be noted that, in the above four embodiments of the pulse ablation catheter, the sheath tube 92 is an adjustable bending sheath tube.

[0127] Furthermore, if bidirectional bending of the ablation catheter is required, another set of pulling members 91 is added. At this time, one end of the added pulling member 91 is connected to the distal end of the first catheter 1, and the other end of the pulling member 91 is connected to the external handle.

[0128] When using the four aforementioned pulse ablation catheters, the sheath 92 is inserted into the femoral veins at the groin on either side. The catheter then travels along the veins to the right atrium, puncturing the atrial septum and reaching the left atrium for ablation at the pulmonary vein vestibule or ostium. Prior to ablation, the catheter is moved from a retracted state within the sheath 92, along its axis, toward the side away from the external handle, until it transitions from the retracted state to a transitional state and then to an expanded state.

[0129] Obviously, the above embodiments are merely examples for clarity of explanation and are not intended to limit the implementation methods. Those skilled in the art will readily appreciate that other variations or modifications based on the above descriptions are possible. It is not necessary and impossible to enumerate all implementation methods here. Obvious variations or modifications arising therefrom remain within the scope of protection of the present invention.

Claims

1. A pulse ablation catheter, characterized in that: include: A first conduit (1), the first conduit (1) being provided with a proximal end arranged close to an external handle member and a distal end arranged away from the proximal end; An ablation component is installed at the distal end, and comprises an insulating film (21) and an electrode (22). The electrode (22) is directly or indirectly installed on the outer wall surface of the insulating film (21).

2. The pulse ablation catheter according to claim 1, characterized in that: Also includes: A second conduit (3), wherein the second conduit (3) is coaxially arranged with the first conduit (1), and the second conduit (3) is located inside the first conduit (1).

3. The pulse ablation catheter according to claim 2, characterized in that: The second conduit (3) is capable of rotating along the circumferential direction of the first conduit (1); The ablation component also includes a plurality of groups of splines (23), wherein one end of the plurality of groups of splines (23) away from the external handle is installed on the inner wall surface of the insulating film (21), and one end of any of the splines (23) close to the external handle is located inside the first catheter (1) along the radial direction of the first catheter (1).

4. The pulse ablation catheter according to claim 3, characterized in that: It also comprises a plurality of connecting members (4), wherein the plurality of connecting members (4) are arranged corresponding to the splines (23), and the connecting members (4) are all sleeved on the outer wall surface of the splines (23), and the plurality of connecting members (4) are rotatably connected.

5. The pulse ablation catheter according to claim 4, characterized in that: The splines (23) are provided in two groups, one group of the splines (23) encloses a receiving cavity, and the other group of the splines (23) is located in the receiving cavity; Two connecting members (4) are provided, one connecting member (4) is provided with a first rotating part (401), and the other connecting member (4) is provided with a second rotating part (402), one of the first rotating part (401) and the second rotating part (402) is provided with a limiting protrusion, and the other of the first rotating part (401) and the second rotating part (402) is provided with a mounting groove, and the limiting protrusion is rotatably mounted in the mounting groove; Wherein, an external force directly or indirectly acts on one or both of the two connecting members (4) so ​​that the two groups of splines (23) are coplanarly arranged or the two groups of splines (23) are cross-arranged, and the two groups of splines (23) are switched between the coplanar arrangement and the cross-arrangement.

6. The pulse ablation catheter according to claim 4 or 5, characterized in that: The spline (23) comprises a first connecting portion (231) and a second connecting portion (232) connected to the first connecting portion (231), wherein the first connecting portion (231) is arranged close to the connecting member (4); A plurality of the electrodes (22) are provided, and the plurality of the electrodes (22) are respectively mounted on the first connecting portion (231) and the second connecting portion (232).

7. The pulse ablation catheter according to claim 2, characterized in that: The second conduit (3) is capable of moving inside the first conduit (1) along the axial direction of the first conduit (1); Also includes: A fixing member (5), the fixing member (5) is in a columnar structure, and the fixing member (5) is sleeved outside the second conduit (3); A plurality of support members (6), each of the support members (6) being made of a memory alloy material, each of the support members (6) being located on a side of the first conduit (1) away from the external handle member, and each of the support members (6) being connected to the fixing member (5); Wherein, the second conduit (3) can slide along the axial direction of the first conduit (1) under the action of an external force, so that the plurality of support members (6) close to the side of the first conduit (1) move away from each other along the radial direction of the first conduit (1), until the insulating film (21) presents an umbrella-shaped structure.

8. The pulse ablation catheter according to claim 7, characterized in that: The fixing member (5) is located outside the insulating film (21); or the fixing member (5) is located inside the insulating film (21).

9. The pulse ablation catheter according to claim 7, characterized in that: It also includes: a flexible electrical connector (7), the flexible electrical connector (7) being mounted on the outer wall surface of the insulating film (21); The electrode (22) is installed on a side of the flexible electrical connector (7) away from the insulating film (21), and the electrode (22) is electrically connected to an external power source via the flexible electrical connector (7) and a wire.

10. The pulse ablation catheter according to any one of claims 7 to 9, characterized in that: The electrode (22) has a flat structure or a planar structure.

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