Occlusion ablation device

Abstract

The present application discloses a plugging ablation device, which includes a support framework that fits against the inner wall of the left atrial appendage. The support framework includes an anchoring portion, a sealing portion, and an ablation portion, and the ablation portion is provided with electrodes. The electrodes include at least one first electrode and one second electrode. The first electrode and the second electrode are respectively connected to the two poles of a pulse source. The electrodes can transmit high-voltage pulse energy to form an annular ablation region. The sealing portion is used to plug the left atrial appendage, and the anchoring portion is used to fix the entire device inside the left atrial appendage, completely blocking the electrophysiological signals on the inner wall of the left atrial appendage to achieve the purpose of restoring sinus rhythm. The sealing portion plugs the left atrial appendage to achieve the purpose of stroke prevention. Thus, an operating instrument can perform pulse ablation treatment and left atrial appendage plugging simultaneously, that is, an operating instrument can play the roles of restoring sinus rhythm and preventing stroke at the same time, solving the problem in the prior art that two separate surgeries and two instruments are required.

Description

Technical Field

[0001] This application relates to the field of medical devices, and particularly to a plugging and ablation device. Background Art

[0002] Atrial fibrillation (referred to as AF) is the most common persistent arrhythmia. With the increase in age, the incidence of AF continues to increase, reaching 10% in people over 75 years old. During AF, the atrial activation frequency reaches 300 - 600 beats per minute. The heart rate is often fast and irregular, sometimes reaching 100 - 160 beats per minute. It is not only much faster than the normal heart rate but also completely irregular, and the atrium loses its effective contraction function.

[0003] Currently, the main treatment method for AF is ablation therapy, which includes thermal ablation (radiofrequency ablation, laser ablation, microwave ablation, thermal substance ablation, etc.), and there is also pulsed ablation using the principle of bioelectroporation. After thermal ablation or pulsed ablation treatment, in general, the AF of patients can be effectively treated, that is, the patients can restore sinus rhythm.

[0004] Due to its special shape and structure, the left atrial appendage (LAA) is not only the main site for thrombus formation in atrial fibrillation (AF), but also one of the key regions for the occurrence and maintenance of AF. Clinical studies have shown that in non-valvular AF patients who have thromboembolic events, 90% of the thrombus sources come from the left atrial appendage. The left atrial appendage occlusion is to close the root site of thrombus formation in AF patients - the left atrial appendage, thereby reducing the stroke risk of AF patients. Therefore, left atrial appendage occlusion is of milestone significance for thrombus prevention in non-valvular AF patients. By isolating the left atrium from the left atrial appendage, the purpose of preventing the thrombus in the left atrial appendage from falling off and causing a stroke is achieved. Therefore, in order to prevent the occurrence of AF thromboembolism, current operators occlude the LAA with an occluder, thereby playing a role in preventing the occurrence of AF thromboembolism, that is, playing a role in stroke prevention.

[0005] From the overall perspective of atrial fibrillation treatment, restoring sinus rhythm and preventing stroke are equally important. Currently, some operators combine occlusion therapy and ablation therapy to achieve the goals of restoring sinus rhythm and preventing stroke. However, the current combined treatment method requires the use of two devices, namely an occluder and an ablation catheter, and the operation is very cumbersome. Usually, one can choose to perform occlusion first and then ablation, or ablation first and then occlusion. When using the method of occlusion first and then ablation, first use the occluder for occlusion, and then place the ablation catheter in the body for ablation. The need to perform two-step operations is already time-consuming, and at the same time, it is necessary to avoid the accident of the ablation catheter damaging the occluder during the operation, so the operation difficulty is extremely high. If the method of ablation first and then occlusion is used, the ablation will cause temporary damage to the orifice of the left atrial appendage, resulting in local tissue swelling. At this time, left atrial appendage occlusion may occur leakage, resulting in occlusion failure. Therefore, there is an urgent need for a medical device that can solve the above problems. Summary of the Invention

[0006] The purpose of the present application is to provide a occlusion ablation device to solve the above problems, use one device to achieve ablation therapy and occlusion therapy, and the ablation therapy can completely block the electrophysiological signals on the inner wall of the left atrial appendage, simplify the operation process, and increase the surgical safety factor.

[0007] The occlusion ablation device provided by the present application includes a support framework attached to the inner wall of the left atrial appendage. The support framework includes an anchoring part, a sealing part, and an ablation part. The ablation part is provided with electrodes; the electrodes include at least one first electrode and one second electrode; the first electrode and the second electrode are respectively connected to the two poles of a pulse source; the electrodes can transmit high-voltage pulse energy to form an annular ablation area.

[0008] The occlusion ablation device as described above, wherein, further includes a connection end, and the connection end is fixedly connected to the proximal end of the sealing part.

[0009] The occlusion ablation device as described above, wherein, both the first electrode and the second electrode are one of metal wires or metal sheets; or: the first electrode is a metal wire or a metal sheet, and the second electrode is an electrically exposed area of the support framework.

[0010] The occlusion ablation device as described above, wherein, the metal wire is any one of serrated, straight, or spring-shaped.

[0011] The occlusion ablation device as described above, wherein, the first electrode and the second electrode surround the outer periphery of the support framework in a circular shape, or surround half of the outer periphery of the support framework in a semi-circular shape, or surround a part of the outer periphery of the support framework in an arc shape.

[0012] The occlusion ablation device as described above, wherein the ablation part further includes a first transmission wire, one end of the first transmission wire is connected to the first electrode, and the other end of the first transmission wire is used to be connected to one pole of the pulse source; the ablation part further includes a second transmission wire, one end of the second transmission wire is connected to the second electrode, and the other end of the second transmission wire is used to be connected to the other pole of the pulse source.

[0013] The occlusion ablation device as described above, wherein the electrically exposed area is electrically connected to the pulse source through the support framework and the connection end.

[0014] The occlusion ablation device as described above, wherein the outer layers of the support framework, the connection end, the first transmission wire and the second transmission wire are all insulated.

[0015] The occlusion ablation device as described above, wherein the first electrode includes a plurality of first sub - electrodes, and the second electrode includes a plurality of second sub - electrodes; each of the first sub - electrodes is connected to one of the first transmission wires, and each of the second sub - electrodes is connected to one of the second transmission wires.

[0016] The occlusion ablation device as described above, wherein the first sub - electrodes, the second sub - electrodes, and the first transmission wires and the second transmission wires respectively connected thereto are all fixed on a fixed sheath; the fixed sheath is a hollow structure made of flexible insulating material.

[0017] The occlusion ablation device as described above, wherein the fixed sheath includes an extension sheath and an annular sheath that at least surrounds the support framework once, the annular sheath is fixedly connected to the support framework; one end of the extension sheath is fixedly connected to the annular sheath; the first sub - electrodes and the second sub - electrodes are both fixed on the annular sheath, one end of the first transmission wire is fixedly connected to the first sub - electrode, and the other end of the first transmission wire passes through the annular sheath and extends into the extension sheath; one end of the second transmission wire is fixedly connected to the second sub - electrode, and the other end of the second transmission wire passes through the annular sheath and extends into the extension sheath.

[0018] The occlusion ablation device as described above, wherein the first electrode and the second electrode share one fixed sheath, and the first sub - electrodes and the second sub - electrodes are fixedly arranged in a cross - spaced manner on the outer side of the same annular sheath; or the first electrode and the second electrode each use one fixed sheath, the first sub - electrodes are fixedly arranged at intervals on the outer side of the corresponding annular sheath, and the second sub - electrodes are fixedly arranged at intervals on the outer side of the corresponding annular sheath.

[0019] The occlusion ablation device as described above, wherein when the first electrode and the second electrode share one fixed sheath tube, the first sub-electrodes and the second sub-electrodes are alternately and equally spaced on the annular sheath tube; when the first electrode and the second electrode each use one fixed sheath tube, the first sub-electrodes are equally spaced on the annular sheath tube used by the first transmission wire, and the second sub-electrodes are equally spaced on the annular sheath tube used by the second transmission wire.

[0020] The occlusion ablation device as described above, wherein the first sub-electrodes and the second sub-electrodes are both sub-metal sheets; the shape of the sub-metal sheet is any one of L-shaped, strip-shaped, circular or triangular.

[0021] The occlusion ablation device as described above, wherein part or all of the electrodes are detachably connected to the support framework, and the part of the electrode detachably connected to the support framework can be withdrawn from the body by an external force.

[0022] The occlusion ablation device as described above, wherein the support framework is a grid-shaped framework made of elastic metal wire braiding or elastic metal laser cutting and heat setting.

[0023] The occlusion ablation device as described above, wherein the electrode is made of any one of platinum, platinum-iridium alloy, gold, nitinol or stainless steel.

[0024] An occlusion ablation device provided by the present application includes a support framework attached to the inner wall of the left atrial appendage. The support framework includes an anchoring portion, a sealing portion and an ablation portion. The ablation portion is provided with electrodes; the electrodes include at least one first electrode and one second electrode; the first electrode and the second electrode are respectively connected to two poles of a pulse source; the electrodes can transmit high-voltage pulse energy to form an annular ablation region. The sealing portion is used to occlude the left atrial appendage, the anchoring portion is used to fix the whole device inside the left atrial appendage, and the ablation portion is used to completely block the electrophysiological signals on the inner wall of the left atrial appendage to achieve the purpose of restoring sinus rhythm. The sealing portion occludes the left atrial appendage to achieve the purpose of stroke prevention. Thus, an operating instrument can simultaneously perform pulse ablation treatment and left atrial appendage occlusion, that is, an operating instrument simultaneously plays the role of restoring sinus rhythm and preventing stroke, and solves the problem in the prior art that separate surgeries and two instruments are required. BRIEF DESCRIPTION OF THE DRAWINGS

[0025] In order to more clearly illustrate the technical solutions of the present invention, the drawings required for the embodiments will be briefly introduced below. Obviously, the drawings in the following description are only some embodiments of the present invention. For those of ordinary skill in the art, other drawings can be obtained from these drawings without creative efforts.

[0026] Figure 1 is the front view of the occlusion ablation device provided by the first embodiment of the present invention;

[0027] Figure 2 is the front view of the occlusion ablation device provided by the second embodiment of the present invention;

[0028] Figure 3 is the front view of the occlusion ablation device provided by the third embodiment of the present invention;

[0029] Figure 4 is the front view of the occlusion ablation device provided by the fourth embodiment of the present invention;

[0030] Figure 5 is the sectional view taken along the line A-A of the annular sheath and the second sub-electrode of the occlusion ablation device provided by the fourth embodiment of the present invention;

[0031] Figure 6 is the structural schematic diagram of the connection end of the occlusion ablation device provided by the fourth embodiment of the present invention;

[0032] Figure 7 is the top view taken along the line B of the annular sheath and the second electrode of the occlusion ablation device provided by the fourth embodiment of the present invention;

[0033] Figure 8 is the front view of the occlusion ablation device provided by the fifth embodiment of the present invention;

[0034] Figure 9 is the front view of another occlusion ablation device provided by the fifth embodiment of the present invention;

[0035] Figure 10 is the structural schematic diagram of the first electrode and the second electrode of the occlusion ablation device provided by the fifth embodiment of the present invention.

[0036] Explanation of reference numerals:

[0037] 10 - sealing part, 11 - clearance section, 12 - interference section, 13 - flow blocking film, 20 - anchoring part, 21 - barbs, 30 - ablation part, 31 - support framework, 32 - first electrode, 321 - first sub-electrode, 33 - second electrode, 331 - second sub-electrode, 34 - first transmission wire, 35 - second transmission wire, 36 - fixed sheath, 361 - extension sheath, 362 - annular sheath, 40 - connecting piece, 50 - connection end, 51 - jack. Detailed description of the specific embodiments

[0038] The following will clearly and completely describe the technical solutions in the embodiments of the present invention with reference to the accompanying drawings in the embodiments of the present invention. Obviously, the described embodiments are only a part of the embodiments of the present invention, rather than all the embodiments. All other embodiments obtained by those of ordinary skill in the art based on the embodiments of the present invention without making creative efforts fall within the protection scope of the present invention.

[0039] In the embodiments of the present invention, the end relatively far from the operator is the distal end, and the end relatively close to the operator is the proximal end.

[0040] Please refer to Figures 1 to 4 As shown, the embodiments of the present invention provide a plugging and ablation device, a support framework that fits on the inner wall of the left atrial appendage. The support framework includes a sealing portion 10, an anchoring portion 20, and an ablation portion 30. The distal end of the sealing portion 10 is fixedly connected to the proximal end of the anchoring portion 20. The plugging and ablation device further includes an ablation portion 30; electrodes are provided on the ablation portion 30, and the electrodes at least include a first electrode 32 and a second electrode 33; that is, the first electrode 32 and the second electrode 33 are respectively used to be connected to the two poles of the pulse source; the electrodes, namely the first electrode 32 and the second electrode 33, can transmit high-voltage pulse energy to form an annular ablation area. The electrodes are made of any one of platinum, platinum-iridium alloy, gold, nickel-titanium alloy, or stainless steel.

[0041] The pulse source can generate single-phase pulses or biphasic pulses; one pole of the pulse source is connected to the first electrode 32, and the other pole of the pulse source is connected to the second electrode 33; when energized, the first electrode 32 and the second electrode 33 generate high-voltage pulse energy. During actual use, parameters such as the voltage and pulse width of the pulse source can be selected to adapt to the ablation of tissues with different thicknesses.

[0042] During actual use, the sealing portion 10 is located at the proximal end of the operator to seal the entrance of the left atrial appendage, the anchoring portion 20 is located at the distal end of the operator to anchor the plugging and ablation device in the left atrial appendage, and the ablation portion 30 is used to perform annular ablation on the inner wall near the entrance of the left atrial appendage.

[0043] The function of the sealing portion 10 is to block and separate the left atrial body and the left atrial appendage to prevent thrombus in the left atrial appendage from entering the left atrium. The anchoring portion 20 can firmly fix the entire left atrial appendage plugging and ablation device in the left atrial appendage; and, in any embodiment, the ablation portion 30 is provided between the sealing portion 10 and the anchoring portion 20 and is close to or at the entrance of the left atrial appendage after being implanted in the body during use; annular ablation is performed on the inner wall at or near the entrance of the left atrial appendage through the first electrode 32 and the second electrode 33 to increase the cure success rate of atrial fibrillation ablation.

[0044] When using the occlusion ablation device provided by the embodiment of the present invention, the sealing portion 10 is located at the proximal end, and the anchoring portion 20 is located at the distal end. The occlusion ablation device is delivered to the position of the left atrial appendage of the heart by means of percutaneous puncture using a delivery sheath. Among them, the anchoring portion 20 is placed inside the left atrial appendage, and the sealing portion 10 occludes at the entrance of the left atrial appendage or at a position close to the entrance of the left atrial appendage, sealing the entrance of the left atrial appendage. At this time, the outer surface of the support frame 31 fits or substantially fits with the inner wall of the left atrial appendage, ensuring that the lesion site to be ablated is located within the annular ablation region. Then, the first electrode 32 and the second electrode 33 are respectively connected to the two poles of the pulse source, and the pulse source is started. The first electrode 32 and the second electrode 33 perform annular ablation on the entrance of the left atrial appendage or a position close to the entrance of the left atrial appendage by transmitting high-voltage pulse energy. At this time, the inner wall cells at the entrance of the left atrial appendage or a position close to the entrance of the left atrial appendage undergo irreversible electroporation, that is, the electrophysiological signals of the inner wall of the left atrial appendage are completely blocked, and apoptosis is achieved, thereby achieving the effect of non-thermal effect ablation of cells.

[0045] As can be seen from the above, the occlusion ablation device provided by the embodiment of the present invention, wherein the sealing portion 10 is used to occlude the left atrial appendage, and the anchoring portion 20 is used to fix the whole device inside the left atrial appendage, completely blocking the electrophysiological signals on the inner wall of the left atrial appendage, so as to achieve the purpose of restoring sinus rhythm. The sealing portion 10 occludes the left atrial appendage to achieve the purpose of stroke prevention. Thus, an operating instrument can perform pulse ablation treatment and left atrial appendage occlusion simultaneously, that is, an operating instrument can play the roles of restoring sinus rhythm and preventing stroke at the same time, solving the problem in the prior art that two separate surgeries and two instruments are required. Since only one operating instrument is needed, the operation difficulty of the operator is greatly reduced, the risk during the operation is significantly reduced, the operation procedure is simplified, the surgical safety factor is increased, and the ablation is more thorough with better treatment effect. In this embodiment, the treatment of atrial fibrillation is achieved by means of pulse ablation, enabling the patient to restore sinus rhythm. Pulse ablation uses high-intensity high-voltage pulse energy to cause irreversible electrical breakdown of cell membranes, which is called irreversible electroporation (IRE) in the medical field (that is, completely destroying the cell tissue with abnormal electrophysiology), causing apoptosis of cells to achieve non-thermal effect ablation of cells, so it is not affected by the heat sink effect. The high-voltage pulse energy generates less heat and does not require saline flushing for cooling, which can effectively reduce the occurrence of gas explosion, eschar and thrombus. In addition, the pulse ablation treatment time is short. The treatment time for applying a group of pulse sequences is less than 1 minute, and the total ablation time generally does not exceed 5 minutes. And because different tissues have different response thresholds to the pulsed electric field, it is possible to ablate the cells with abnormal electrophysiology in the myocardium without interfering with other adjacent tissues, thereby avoiding accidental injury to the tissues adjacent to the left atrial appendage. Moreover, the electric field lines continuously start from the positive charge to the negative charge, and the electrodes can be arranged in the form that the electric field lines are concentrated in the annular region to perform annular ablation on the inner wall of the left atrial appendage. In addition, compared with other energies, pulse ablation does not require heat conduction to ablate deep tissues, and all myocardial cells distributed above a certain electric field strength will undergo electroporation, reducing the requirement for the catheter apposition pressure during ablation. Therefore, even if the ablation portion 30 does not completely fit the inner wall of the left atrial appendage after entering the left atrial appendage, it does not affect the IRE ablation effect.

[0046] Further, both the first electrode 32 and the second electrode 33 are made of a biocompatible metal material. In one embodiment, the first electrode 32 and the second electrode 33 can be made of any one of platinum, platinum-iridium alloy, gold, nitinol or stainless steel.

[0047] Further, the ablation portion 30 of the occlusion ablation device provided by the embodiment of the present invention further includes a first transmission wire 34 and a second transmission wire 35. One end of the first transmission wire 34 is connected to the first electrode 32, and the other end of the first transmission wire 34 is used to connect to one pole of the pulse source. One end of the second transmission wire 35 is connected to the second electrode 33, and the other end of the second transmission wire 35 is used to connect to the other pole of the pulse source.

[0048] Those skilled in the art can understand that the above-mentioned first transmission wire 34 and second transmission wire 35 are respectively used to electrically connect the first electrode 32 and the second electrode 33 to the two poles of the pulse source, so as to facilitate the pulse source to provide high-voltage pulses to the first electrode 32 and the second electrode 33, enabling the operator to smoothly perform the operation.

[0049] Those skilled in the art can also understand that the above-mentioned first transmission wire 34 and second transmission wire 35 can be directly or indirectly connected to the two poles of the pulse source by metal wires or steel cables.

[0050] Preferably, both the first transmission wire 34 and the second transmission wire 35 are insulated. Specifically, the outer layers of the first transmission wire 34 and the second transmission wire 35 are both coated with wire insulation layers; or the outer layers of the first transmission wire 34 and the second transmission wire 35 are both sleeved with wire insulation sheath tubes. The above-mentioned wire insulation layers and wire insulation sheath tubes are all made of any one of polyester, polyurethane, polyimide, perfluoroethylene propylene copolymer, ethylene-tetrafluoroethylene copolymer, soluble polytetrafluoroethylene or parylene.

[0051] In one embodiment, please refer to Figure 1 , the first transmission wire 34 can directly extend to the outside of the body and be connected to one pole of the pulse source; please refer to Figure 3 , the first transmission wire (not shown in the figure) and the second transmission wire (not shown in the figure) can directly extend to the outside of the body and be connected to the two poles of the pulse source, and the first transmission wire and the second transmission wire are located in the fixed sheath tube 36.

[0052] In one embodiment, please refer to Figure 2 , it further includes a connection end 50, and the connection end 50 is fixedly connected to the proximal end of the sealing portion 10. Then, hollow holes can be provided in the support frame 31 and the connection end 50. Both the first transmission wire 34 and the second transmission wire 35 pass through the hollow holes of the support frame 31 and the connection end 50, and then extend into the delivery device to be electrically connected to the two poles of the pulse source. In addition, an external thread is provided on the outside of the connection end 50 ( Figure 2 the upper end in the figure), and the external thread can be fixedly connected to the steel cable, so as to achieve mechanical connection and prevent the connection from loosening. Of course, it can also be that only the second transmission wire is connected by means of a jack, while the first transmission wire 34 is connected in the manner shown in Figure 1 in the figure.

[0053] Furthermore, the first transmission wire 34 and the first electrode 32 can be integrally formed or welded. Similarly, the second transmission wire 35 and the second electrode 33 can also be integrally formed or welded. In particular, when the first electrode 32 and the first transmission wire 34 are made of the same material, it is preferred that they be integrally formed. When the first electrode 32 and the first transmission wire 34 are made of different materials, for example, in order to reduce costs, the first electrode 32 is made of platinum and the first transmission wire 34 is made of copper. At this time, the first electrode 32 and the first transmission wire 34 can be formed by welding. Of course, it can also be as Figure 4 shown, the first transmission wire is composed of a metal wire inside the fixed sheath 36 and a steel cable connected to the connection end 50. The second transmission wire 35 and the second electrode 33 are the same.

[0054] There are also various specific implementation methods for the first electrode 32 and the second electrode 33, based on the principle that the first electrode 32 and the second electrode 33 can transmit high-voltage pulses. The first electrode 32 and the second electrode 33 are both one of a metal wire or a metal sheet; or the first electrode 32 is a metal wire or a metal sheet, and the second electrode 33 is the electrically exposed area of the support frame.

[0055] The first electrode and the second electrode surround the outer periphery of the support frame in a circular shape, or surround half of the outer periphery of the support frame in a semi-circular shape, or surround a part of the outer periphery of the support frame in an arc shape. For example: both the first electrode 32 and the second electrode 33 are metal wires (similar to electric wires) surrounding the support frame 31 in a circle; or both the first electrode 32 and the second electrode 33 are metal sheets (similar to belts) surrounding the support frame 31 in a circle; or the first electrode 32 is a metal wire or a metal sheet surrounding the support frame 31 in a circle, and the second electrode 33 is the electrically exposed area surrounding the support frame 31 in a circle; or the first electrode 32 is a semi-circular metal wire or metal sheet surrounding half of the support frame 31, and the second electrode 33 is a semi-circular metal wire or metal sheet corresponding to the first electrode 32 surrounding half of the support frame 31, and the first electrode 32 and the second electrode 33 form a complete ring; or the first electrode 32 is an arc-shaped metal wire or metal sheet surrounding one-fourth of the support frame 31, and the second electrode 33 is an arc-shaped metal wire or metal sheet surrounding three-fourths of the support frame 31, and the two form a complete ring.

[0056] In another embodiment, please refer to Figure 2 , both the first electrode 32 and the second electrode 33 are metal wires surrounding the support frame 31 in a circle. The above metal wires are fixed to the support frame 31 by bundling or stitching.

[0057] In this embodiment, the wire can also be set in a serrated shape. The advantage of this shape of wire is that it is easy to compress. That is, when the support skeleton 31 is retracted into the delivery sheath tube, the serrated wire can be folded and bent and retracted into the delivery sheath tube. In addition, during ablation, the high-voltage pulse source generated by the electrode of this shape is more concentrated between the first electrode and the second electrode, so that the ablation directionality is stronger, more uniform, and the muscle stimulation is smaller. Of course, the wire can also be in any one of a straight shape or a spring shape. Based on the fact that the wire is made of a flexible material, those skilled in the art can fold it into any applicable shape, which all fall within the protection scope of this application and will not be elaborated here.

[0058] In another embodiment, please refer to Figure 1 , the first electrode 32 is a ring-shaped wire that surrounds the support skeleton 31 for one circle, and the second electrode 33 is an annular electrically exposed area that surrounds the support skeleton 31 for one circle. This ring-shaped wire is also fixed to the support skeleton 31 by means of tying or suturing.

[0059] The second electrode 33, that is, the annular electrically exposed area, is electrically connected to the second transmission wire 35 through the support skeleton 31 and the connection end 50.

[0060] For the occlusion ablation device provided by the embodiment of the present invention, at least the ablation part 30 is insulated. Specifically, in this embodiment, an insulating component is arranged outside the ablation part 30 to avoid the non-insulated part interfering with the electric field and thus affecting the treatment effect. More preferably, for the entire occlusion ablation device, except for the first electrode 32 and the second electrode 33, the remaining parts are all insulated, including but not limited to the sealing part 10, the anchoring part 20, the ablation part 30, etc. Then the annular electrically exposed area is actually to strip a circle of insulating components on the support skeleton 31, so that the conductive metal of this circle of the support skeleton 31 is exposed as the second electrode 33. Since both the support skeleton 31 and the connection end 50 are made of conductive materials, therefore, the second transmission wire 35 is directly connected to the support skeleton 31, which can ensure that the second electrode 33 can be energized. It can be understood that when the second electrode 33 is an annular electrically exposed area that surrounds the support skeleton 31 for one circle, at this time, the second transmission wire 35 does not need to pass through components such as the sealing part 10 and the support skeleton 31, and is directly threadedly connected to the connection end 50. It can be both electrically connected to the occlusion ablation device to conduct the pulse energy source and mechanically connected to it.

[0061] Preferably, when the treatment is over, in order to avoid the electrode remaining in the patient's body and causing an impact on the patient, the first electrode 32 and the second electrode 33 can be withdrawn from the patient's body. At this time, the electrode is partially or fully detachably connected to the support skeleton 31, and the detachable part can be withdrawn from the body by an external force. Please refer to Figure 1, the first electrode 34 can be withdrawn from the body, specifically, the first electrode 34 can be detached from the support frame 31 by an external force.

[0062] In another embodiment, please refer to Figure 3 and Figure 4 , the first electrode 32 includes a plurality of first sub - electrodes 321, and the second electrode 33 includes a plurality of second sub - electrodes 331; both the first sub - electrodes 321 and the second sub - electrodes 331 are connected to the support frame 31 through a fixed sheath 36; each first sub - electrode 321 is connected to a first transmission wire (not shown in the figure), and each second sub - electrode 331 is connected to a second transmission wire (not shown in the figure). The above - mentioned fixed sheath 36 is a hollow structure made of a flexible insulating material, such as plastic.

[0063] Further, please continue to refer to Figure 3 and Figure 4 , the fixed sheath 36 includes an extension sheath 361 and an annular sheath 362 that surrounds the support frame 31 in a circle. The annular sheath 362 is fixedly connected to the support frame 31; one end of the extension sheath 361 is fixedly connected to the annular sheath 362. Both the first sub - electrodes 321 and the second sub - electrodes 331 are fixed on the annular sheath 362. One end of the first transmission wire is fixedly connected to the first sub - electrode 321, and the other end of the first transmission wire passes through the annular sheath 362 and extends into the extension sheath 361. One end of the second transmission wire is fixedly connected to the second sub - electrode 331, and the other end of the second transmission wire passes through the annular sheath 362 and extends into the extension sheath 361. Figure 3 and Figure 4 In

[0064] , the first transmission wire and the second transmission wire are located in the fixed sheath 36, not shown in the figure.

[0065] In one embodiment, please refer to Figure 3 , the first electrode 32 and the second electrode 33 share a fixed sheath 36, and the first sub - electrodes 321 and the second sub - electrodes 331 are fixedly arranged cross - spaced on the outer side of the same annular sheath 362. Preferably, when the first electrode 32 and the second electrode 33 share a fixed sheath 36, the first sub - electrodes 321 and the second sub - electrodes 331 are alternately and equally spaced on the annular sheath 362. The advantage of the equal - spacing distribution is that it makes the electric field distribution more uniform.

[0066] In another preferred embodiment, please refer to Figure 4, for the first electrode 32 and the second electrode 33, each uses a fixed sheath 36. The first sub-electrodes 321 are fixedly spaced apart on the outer side of the corresponding annular sheath 362, and the second sub-electrodes 331 are fixedly spaced apart on the outer side of the corresponding annular sheath 362. Preferably, when the first electrode 32 and the second electrode 33 each use a fixed sheath 36, the first sub-electrodes 321 are equally spaced on the annular sheath 362, and the second sub-electrodes 331 are equally spaced on the annular sheath 362. Similarly, the advantage of equal spacing is that it makes the electric field distribution more uniform.

[0067] Preferably, the above-mentioned first sub-electrodes 321 and second sub-electrodes 331 are both sub-metal sheets, and the shape of the sub-metal sheet is L-shaped, strip-shaped, circular or triangular, etc. Please refer to Figure 5 , taking the cross-section of the metal sheet as L-shaped as an example. Especially when the first electrode 32 and the second electrode 33 each use a fixed sheath 36, the first sub-electrodes 321 are fixedly spaced apart on the outer side of the corresponding annular sheath 362, and the second sub-electrodes 331 are fixedly spaced apart on the outer side of the corresponding annular sheath 362. At this time, by using L-shaped sub-metal sheets, the electric field intensity in the atrial appendage wall area between the first electrode 32 and the second electrode 33 can be increased, so that the electric field is more evenly distributed on the inner wall of the left atrial appendage, the electric field intensity distributed on the inner wall of the left atrial appendage is greater, and circumferential ablation is more likely to penetrate the wall.

[0068] Please refer to Figure 4 , hollow holes can be provided on the support frame 31, and jacks 51 can be provided on the connection end 50 (please refer to Figure 6 ). Taking the direction in Figure 4 as a reference, the jack 51 is located at one end of the connection end 50 facing the delivery sheath. The number of jacks 51 is the same as the total number of the first transmission wire and the second transmission wire. The first transmission wire (not shown in the figure) and the second transmission wire (not shown in the figure) can pass through the hollow holes on the support frame 31 and then be fixedly connected to the jacks 51 one by one. The first transmission wire and the second transmission wire are located in the fixed sheath 36. In addition, external threads are provided on the outer side of the connection end 50 ( Figure 4 the upper end in the figure), and the external threads can be fixedly connected to the steel cable, so as to achieve mechanical connection and prevent loosening at the connection. Then the steel cable is provided with insertion pins, and the number of insertion pins is the same as the total number of the first transmission wire and the second transmission wire. The steel cable is preferably made of platinum or copper and can be connected to the two poles of the pulse source to achieve electrical connection. At this time, a plurality of guiding heads for one pole and the other pole of the pulse source are also correspondingly provided, corresponding to the number of the first transmission wire and the second transmission wire, so as to independently control the electric field of each sub-electrode.

[0069] Compared with Figure 1In the way that the first lead wire 34 extends directly and passes through the hollow hole, the volume of the whole device can be reduced, thereby reducing the degree of harm to the patient. The first lead wire and the second lead wire are both preferably made of platinum or copper. Of course, the first lead wire and the second lead wire can also be made of other electrically conductive metals, which are not limited herein.

[0070] Furthermore, the electrode can also be connected to a polygraph recorder and can also collect intracardiac electrical signals to detect whether the electrophysiological signals on the inner wall of the left atrial appendage are completely blocked, so as to ensure that the treatment can eliminate arrhythmia and restore normal sinus rhythm.

[0071] Similar to the way of using metal wires, in the way of using the first sub-electrode 321 and the second sub-electrode 331, after the treatment is completed, the first electrode 32 and the second electrode 33 can also be withdrawn from the patient's body. Since both the first sub-electrode 321 and the second sub-electrode 331 are connected to the support framework 31 through the annular sheath 362, only by withdrawing the annular sheath 362 from the body, the first electrode 32 and the second electrode 33 will be withdrawn from the body at the same time. Figure 3 In [the above situation], an external force can be applied to the extension sheath 361, and the extension sheath 361 drives the annular sheath 362 to disengage from the support framework 31, thereby bringing the first electrode and the second electrode out of the body to avoid the electrodes remaining in the body and affecting the patient's body.

[0072] Furthermore, the sealing part 10, the anchoring part 20, and the support framework 31 of the occlusion ablation device provided by the embodiment of the present invention are all grid-shaped rings made by braiding metal wires or heat setting by laser cutting of metal wires. The braided metal wires in this embodiment can be nitinol alloy, cobalt-chromium alloy, stainless steel, or other metal materials with good biocompatibility. Preferably, the superelastic shape memory alloy nitinol wire is used.

[0073] Among them, the ablation part 30, the sealing part 10, and the anchoring part 20 can be integrally formed ( Figure 3 and Figure 8 ), and the ablation part 30 is located between the sealing part 10 and the anchoring part 20. It can be understood that the ablation part 30 is at least the part between the sealing part 10 and the anchoring part 20 that can be fixed or serve as the first electrode 32 and / or the second electrode 33.

[0074] Among them, the sealing part 10 and the anchoring part 20 can also be independently formed ( Figure 1 , Figure 2 , Figure 4 ), specifically, the sealing part 10 and the anchoring part 20 can be fixedly connected through the connecting piece 40. In this case, the ablation part 30 can be integrally formed with the sealing part 10 ( Figure 4 ), or the ablation part 30 can be integrally formed with the anchoring part 20 ( Figure 1 , Figure 2 ,Figure 4 , Figure 9 ) or a part of the ablation portion 30 is integrally formed with the sealing portion 10, and the remaining part is integrally formed with the anchoring portion 20 Figure 4 ). It should be understood that the ablation portion 30 here refers to the support skeleton of the ablation portion 30.

[0075] Preferably, the connecting member 40 is fixedly connected to the sealing portion 10 and the anchoring portion 20 respectively by welding, and the shape of the connecting member 40 is a metal column. The setting of the connecting member 40 can play a role in adjusting the overall length of the occlusion ablation device, so as to facilitate the production of various different models of occlusion ablation devices at the lowest cost and improve the applicability.

[0076] For the occlusion ablation device provided by the embodiment of the present invention, at least the ablation portion 30 is insulated. Specifically, in this embodiment, an insulating member is provided outside the ablation portion 30 to prevent other parts from being electrically conducted with the ablation portion, thereby affecting the treatment effect. More preferably, for the entire occlusion ablation device, except for the first electrode 32 and the second electrode 33, the remaining parts are all insulated, including but not limited to the sealing portion 10, the anchoring portion 20, the ablation portion 30, etc.

[0077] As mentioned above, the entire device needs to be insulated at least at the ablation portion 30. Preferably, the outer sides of the sealing portion 10, the anchoring portion 20, the connecting member 40 and the connection end 50 are all insulated. That is, the entire support skeleton 31 needs to be insulated to prevent other parts from being electrically conducted with the ablation portion and thus affecting the treatment effect.

[0078] The above insulation treatment is an insulating coating applied on the outer surface of the corresponding component, or an insulating sleeve sleeved on the outer surface of the corresponding component. Specifically, both the insulating coating and the insulating sleeve are made of any one of polyester, polyurethane, polyimide, perfluoroethylene propylene copolymer, ethylene-tetrafluoroethylene copolymer, soluble polytetrafluoroethylene or parylene.

[0079] It can be understood that when the connecting member 40 is provided, in order to facilitate the connection of the first transmission wire 34 and the second transmission wire 35 to the two poles of the pulse source, a hollow hole is provided on the connecting member 40.

[0080] Furthermore, a circle of barbs 21 is provided on the anchoring portion 20 along the circumferential direction. One end of each barb 21 is fixedly connected to the outside of the anchoring portion 20, and the other end extends obliquely towards the sealing portion 10. The barb 21 is mainly used to stabilize the entire device in the left atrial appendage and increase the stability of the entire device during the operation process.

[0081] Furthermore, at least one layer of flow-blocking membrane is fixedly connected to the inner or outer side of the sealing part 10, the ablation part 30, and the anchoring part 20. This flow-blocking membrane is mainly used to achieve the sealing function of the ablation device to better block the left atrial appendage inlet. Preferably, the flow-blocking membrane is made of polyethylene terephthalate (PET) or polytetrafluoroethylene (PTFE). The flow-blocking membrane is preferably sutured and fixed inside the sealing part 10, the ablation part 30, and the anchoring part 20.

[0082] To enhance the sealing effect, preferably, the sealing part 10 includes a clearance section 11 and an interference section 12 fixedly connected at the ends ( Figure 4 ), the diameter of the interference section 12 is larger than that of the clearance section 11, and the interference section 12 is located at the end far from the anchoring part 20. Those skilled in the art can understand that after complete release, the outer sides of the sealing part 10, the ablation part 30, and the anchoring part 20 should fit with the left atrial appendage. Setting the diameter of the interference section 12 of the sealing part 10 slightly larger can increase the tightness of the fit between the left atrial appendage and this interference section 12, thereby better closing the left atrial appendage.

[0083] The following lists several more specific embodiments for the understanding of those skilled in the art:

[0084] First Embodiment:

[0085] As Figure 1 shown, the embodiment of the present invention provides a plugging and ablation device. A support skeleton 31 woven from nitinol wire fits against the inner wall of the left atrial appendage. The support skeleton 31 includes a connection end 50, a sealing part 10, a connecting part 40, and an anchoring part 20 fixedly connected in sequence from the proximal end to the distal end. The ablation part 30 is integrally formed with the proximal end of the anchoring part 20. Electrodes are provided on the ablation part 30, including a first electrode 32 and a second electrode 33; the entire support skeleton 31 is coated with parylene for insulation treatment, and a circle of insulating material is peeled off at the anchoring part to leave a circular electrically exposed area. The first electrode 32 is a circular wire surrounding the ablation part 30 once, and the second electrode 33 is a circular electrically exposed area surrounding the ablation part 30 once. In this way, the electric field formed by the two electrodes will concentrate the electric field intensity in the area between the two circles of electrodes. To enhance the sealing effect, the sealing part 10 is a nitinol wire woven disc with a diameter larger than that of the anchoring part 20, and a layer of flow-blocking membrane is sutured inside the woven disc to block the orifice of the left atrial appendage.

[0086] The first electrode 32 is electrically connected to an external pulse source through a first transmission wire 34. One end of the first transmission wire 34 is fixedly connected to the first electrode 32, and the other end is in a freely extending state. During use, the other end of the first transmission wire 34 can be directly extended to connect to one pole of the external pulse source.

[0087] The second electrode 33 is electrically connected to an external pulse source through a steel cable for delivery. Specifically, the steel cable is made of any one of platinum, platinum-iridium alloy, gold, nitinol or stainless steel, and is electrically and mechanically connected to the connection end 50 by means of a threaded connection. Thus, the second electrode 33 is finally electrically connected to the pulse source through the support frame 31, the connecting member 40, the connection end 50 and the steel cable.

[0088] The first electrode 32 and the second electrode 33 serve as the positive and negative poles of the pulsed electric field, causing the electric field to be concentrated in the region between the two electrodes, forming an annular ablation region.

[0089] The following specifically describes the usage method: During the operation, the connection end 50 on the sealing part 10 is connected to a delivery wire such as a steel cable by means of a thread. The entire occlusion and ablation device is inserted into a delivery sheath with a smaller diameter, and then enters the inferior vena cava through femoral vein puncture, then enters the right atrium, and then enters the left atrium through atrial septum puncture. When the left atrial appendage occlusion and ablation device is released, ensure that the anchoring part 20 is released inside the left atrial appendage after release, and the barbs 21 are hooked into the inner wall of the left atrial appendage; the first electrode 32 and the second electrode 33 of the ablation part 30 are closely attached to the inner wall of the left atrial appendage near the entrance, and the flow-blocking membrane in the sealing part 10 occludes the orifice of the left atrial appendage, preventing blood flow from entering the left atrial appendage and preventing thrombus in the left atrial appendage from flowing into the left atrium.

[0090] After the left atrial appendage occlusion and ablation device is released in the left atrial appendage, connect the other end of the first transmission wire 34 to one pole of the pulse source, connect the steel cable to the other pole of the pulse source, and transmit the high-voltage pulse energy to the inner wall of the left atrial appendage, causing irreversible electroporation of the cells at the entrance of the left atrial appendage or near the inner wall of the entrance of the left atrial appendage, thereby achieving apoptosis of the cells and achieving the therapeutic effect of ablating cells with non-thermal effects.

[0091] After the ablation operation is completed, withdraw the first transmission wire 34, driving the first electrode 32, that is, a ring of metal wire, to withdraw from the support frame together, and disconnect the steel cable from the left atrial appendage occlusion and ablation device, so that the support frame of the left atrial appendage occlusion and ablation device remains in the left atrial appendage to achieve long-term occlusion performance, while avoiding the influence of the electrode remaining in the patient's body on the patient's body.

[0092] The occlusion and ablation device provided in this embodiment can utilize the structure of the left atrial appendage occlusion and ablation device itself to achieve occlusion of the left atrial appendage in one operation, and achieve complete ablation and blockage of the orifice of the left atrial appendage, thereby increasing the success rate of atrial fibrillation ablation.

[0093] Those skilled in the art should understand that in this first embodiment, the connection methods of the sealing part 10, the anchoring part 20 and the ablation part 30 can be integrally formed, or connected through a connecting member 40, etc.

[0094] Second Embodiment:

[0095] As Figure 2 shown, an embodiment of the present invention provides a plugging and ablation device. A support framework 31 is woven from nitinol wires, and the entire support framework is coated with parylene for insulation treatment and is attached to the inner wall of the left atrial appendage. The difference from the first embodiment is that both the first electrode 32 and the second electrode 33 are annular serrated metal wires that surround the ablation part 30 in a circle, and the connection end 50 is a hollow structure. Hollow holes are provided on the anchoring part 20, the ablation part 30, the connecting part 40, and the sealing part 10. Both the first transmission wire 34 and the second transmission wire 35 pass through the hollow holes of the support framework 31 and the connection end 50, and then extend into the delivery device to be electrically connected to the two poles of the pulse source. In addition, an external thread is provided on the outer side ( Figure 2 the upper end in

[0096] the figure) of the connection end, and this external thread can be fixedly connected to the steel cable, thereby realizing mechanical connection and preventing loosening at the connection.

[0097] More specifically, except for the first electrode 32 and the second electrode 33, the rest of the device is insulated. And barbs 21 are provided on the anchoring part 20.

[0098] When in use, the first transmission wire 34 and the second transmission wire 35 extend to be respectively connected to the two poles of the pulse source. The specific usage method is the same as that of the first embodiment and will not be elaborated here. The difference is that after ablation, the first transmission wire 34 and the second transmission wire 35 can be retracted by an external force to separate the first electrode 32 and the second electrode 33 from the support framework, and withdrawn from the body, and the delivery device is disengaged from the left atrial appendage plugging and ablation device, so that the support framework of the left atrial appendage plugging and ablation device remains in the left atrial appendage to achieve long-term plugging performance, while avoiding the influence of the electrode remaining in the patient's body on the patient's body.

[0099] Third embodiment:

[0100] As Figure 3 shown, an embodiment of the present invention provides a plugging and ablation device. A support framework 31 is woven from nitinol wires and is attached to the inner wall of the left atrial appendage. The support framework 31 includes a connection end 50, a sealing part 10, and an anchoring part 20 that are fixedly connected in sequence from the proximal end to the distal end, and the ablation part 30 is integrally formed with the proximal end of the anchoring part 20. The anchoring part 20, the ablation part 30, and the sealing part 10 are integrally formed. In order to increase the sealing effect, at least one layer of flow-blocking membrane is sutured inside or outside the sealing part 10 to plug the orifice of the left atrial appendage.

[0101] A fixed sheath tube 36 is provided on the ablation part 30, and a first electrode and a second electrode are fixed on the fixed sheath tube 36; the part of the support framework 31 in contact with the fixed sheath tube 36 is coated with parylene for insulation treatment to prevent the energy loss of the electrodes on the fixed sheath tube 36.

[0102] The first electrode 32 includes a plurality of first sub - electrodes 321, and the second electrode 33 includes a plurality of second sub - electrodes 331; both the first sub - electrodes 321 and the second sub - electrodes 331 are connected to the ablation part 30 through the fixed sheath tube 36; each first sub - electrode 321 is connected with a first transmission wire 34, and each second sub - electrode 331 is connected with a second transmission wire 35.

[0103] The fixed sheath tube 36 includes an extension sheath tube 361 and an annular sheath tube 362 that surrounds the ablation part 30 in a circle. The annular sheath tube 362 is fixedly connected to the ablation part 30; one end of the extension sheath tube 361 is fixedly connected to the annular sheath tube 362.

[0104] Both the first sub - electrodes 321 and the second sub - electrodes 331 are metal rings sleeved on the outer surface of the annular sheath tube 362. Small holes are provided at the part of the annular sheath tube 362 in contact with the metal rings for the first transmission wire 34 and the second transmission wire 35 to pass through. One end of the first transmission wire 34 is fixedly connected to the first sub - electrode 321, and the other end of the first transmission wire 34 passes through the annular sheath tube 362 and extends into the extension sheath tube 361. One end of the second transmission wire 35 is fixedly connected to the second sub - electrode 331, and the other end of the second transmission wire 35 passes through the annular sheath tube 362 and extends into the extension sheath tube 361. The first transmission wire 34 and the second transmission wire 35 extend from the above - mentioned extension sheath tube 361 to be connected to the two poles of the pulse source respectively. The first electrode 32 and the second electrode 33 share one fixed sheath tube 36, and the first sub - electrodes 321 and the second sub - electrodes 331 are fixedly arranged at intervals and cross - spaced on the outside of the same annular sheath tube 362. Preferably, the first sub - electrodes 321 and the second sub - electrodes 331 are alternately and equally - spaced on the annular sheath tube 362. The advantage of the equal - spaced distribution is that it makes the electric field distribution more uniform.

[0105] The basic usage method is the same as that of the first embodiment. The wires of the first sub - electrodes 321 and the second sub - electrodes 331 are respectively connected to the two poles of the pulse source. When the pulse source outputs energy, an electric field is formed between each first sub - electrode 321 and the two adjacent second sub - electrodes 331. Then, multiple dense small electric fields can be formed between the first electrode 32 and the second electrode 33. The multiple small electric fields formed between every two adjacent sub - electrodes enclose a circle to perform annular ablation treatment on the inner wall of the left atrial appendage, improving the efficiency of ablation treatment.

[0106] After the treatment is completed, please refer to Figure 3, an external force can be applied to the extension sheath 361, and the extension sheath 361 drives the annular sheath 362 to disengage from the support framework 31, thereby bringing the first electrode and the second electrode out of the body, leaving the support framework of the left atrial appendage occlusion and ablation device in the left atrial appendage to achieve long-term occlusion performance, while avoiding the electrodes remaining in the body from affecting the patient's body.

[0107] In addition, for the first electrode 32 and the second electrode 33 adopting this method, before and after ablation, an electrocardiograph can be used to collect intracardiac electrical signals, so that the pulse output is in the absolute refractory period, thus not interfering with the heart rate and reducing sudden arrhythmia. After ablation, an electrocardiograph is used to collect intracardiac electrical signals to detect whether the inner wall of the left atrial appendage is completely destroyed by abnormal electrophysiological cell tissues, so as to ensure that the treatment can eliminate arrhythmia and restore sinus rhythm.

[0108] Fourth Embodiment:

[0109] As Figure 4 shown, an embodiment of the present invention provides a occlusion and ablation device. The support framework 31 is woven by nitinol wire and fits against the inner wall of the left atrial appendage. The support framework 31 includes a connection end 50, a sealing part 10, a connecting part 40, and an anchoring part 20 that are fixedly connected in sequence from the proximal end to the distal end. A part of the ablation part 30 is integrally formed with the sealing part 10, and the rest is integrally formed with the anchoring part 20. In order to increase the sealing effect, the sealing part 10 is a nitinol wire woven disk with a diameter larger than that of the anchoring part 20, and a flow blocking film is sutured inside the woven disk to occlude the left atrial appendage orifice (not shown in the figure).

[0110] The difference between the support framework 31 in the embodiment of the present invention and that in the first embodiment is that the sealing part 10 further includes a clearance section 11 and an interference section 12 fixedly connected at the end. The diameter of the interference section 12 is larger than that of the clearance section 11, and the interference section 12 is located at the end far from the anchoring part 20. Setting the diameter of the interference section 12 of the sealing part 10 slightly larger can increase the tightness of the fit between the left atrial appendage and the interference section 12, so as to better seal the left atrial appendage.

[0111] The difference between the ablation part 30 in the embodiment of the present invention and that in the third embodiment is that two fixed sheaths 36 are provided on the ablation part 30 to fix the first electrode 32 and the second electrode 33 respectively. The first electrode 32 includes a plurality of first sub-electrodes 321, and the second electrode 33 includes a plurality of second sub-electrodes 331; both the first sub-electrodes 321 and the second sub-electrodes 331 are connected to the ablation part 30 through the fixed sheath 36; each first sub-electrode 321 is connected with a first transmission wire 34, and each second sub-electrode 331 is connected with a second transmission wire 35.

[0112] The fixed sheath tube 36 includes an extension sheath tube 361 and an annular sheath tube 362 that surrounds the ablation part 30 in a circle. The annular sheath tube 362 is fixedly connected to the ablation part 30; one end of the extension sheath tube 361 is fixedly connected to the annular sheath tube 362. The first sub-electrode 321 and the second sub-electrode 331 are both fixed on the annular sheath tube 362. One end of the first transmission wire 34 is fixedly connected to the first sub-electrode 321, and the other end of the first transmission wire 34 passes through the annular sheath tube 362 and extends into the extension sheath tube 361. One end of the second transmission wire 35 is fixedly connected to the second sub-electrode 331, and the other end of the second transmission wire 35 passes through the annular sheath tube 362 and extends into the extension sheath tube 361.

[0113] Each of the first electrode 32 and the second electrode 33 uses a fixed sheath tube 36. The first sub-electrodes 321 are fixedly spaced on the outer side of the corresponding annular sheath tube 362, and the second sub-electrodes 331 are fixedly spaced on the outer side of the corresponding annular sheath tube 362, as Figure 7 shown. The first sub-electrodes 321 are evenly distributed on the annular sheath tube 362 used by the first transmission wire 34, and the second sub-electrodes 331 are evenly distributed on the annular sheath tube 362 used by the second transmission wire 35.

[0114] Both the first sub-electrode 321 and the second sub-electrode 331 are in the form of electrode plates, and the cross-section of the electrode plate is L-shaped, as Figure 5 shown. The long side of the right-angled metal sheet is fixed on the fixed sheath tube 36, and the short side faces outward. The L-shaped electrode plate can increase the electric field strength in the atrial wall area between the first electrode 32 and the second electrode 33, making the electric field more evenly distributed on the inner wall of the left atrium. The electric field strength distributed on the inner wall of the left atrium is greater, and annular ablation is more likely to penetrate the wall.

[0115] The difference between the support skeleton 31 and the first embodiment is also that hollow holes are provided on the anchoring part 20, the ablation part 30, the connecting part 40, and the sealing part 10. Specifically: hollow holes can be provided on the support skeleton 31, as Figure 6 shown. Jacks 51 are provided at the connection end heads. Taking the direction in Figure 4 as a reference, the jack 51 is located at one end of the connection end head 50 facing the delivery sheath tube. The number of jacks 51 is the same as the total number of the first transmission wire and the second transmission wire. The first transmission wire (not shown in the figure) and the second transmission wire (not shown in the figure) can pass through the hollow holes on the support skeleton 31 and then be fixedly connected to the jacks 51 one by one. The first transmission wire and the second transmission wire are located in the fixed sheath tube 36. In addition, on the outer side of the connection end head 50 ( Figure 4The upper end of [the object] is also provided with an external thread, which can be fixedly connected to the steel cable to achieve mechanical connection and prevent loosening at the connection. Then, the steel cable head is provided with insertion pins, and the number of pins is the same as the total number of the first transmission wire and the second transmission wire. The steel cable is preferably made of platinum or copper and can be connected to the two poles of the pulse source to achieve electrical connection. At this time, the guiding heads of one pole and the other pole of the pulse source are also correspondingly provided with a plurality of them, corresponding to the number of the first transmission wire and the second transmission wire, so as to independently control the electric field of each sub-electrode to achieve the purpose of ablating a specified area.

[0116] As described above, in the fourth embodiment, each of the first electrode 32 and the second electrode 33 uses a single fixed sheath 36. However, according to actual needs, there can be various implementation manners for the fourth embodiment. Several of them are briefly described below:

[0117] In one implementation manner, all the first sub-electrodes 321 are connected to one pole of the pulse source, and all the second sub-electrodes 331 are connected to the other pole of the pulse source. At this time, the area between the first electrode 32 and the second electrode 33 in the left atrial appendage is ablated. It can be understood that the ablation part 30 is fixedly connected to the distal end of the sealing part 10 and the proximal end of the anchoring part 20.

[0118] In another implementation manner, some of the first sub-electrodes 321 are connected to one pole of the pulse source, and the remaining first sub-electrodes 321 are vacant. Some of the second sub-electrodes 331 are connected to the other pole of the pulse source, and the remaining second sub-electrodes 331 are vacant. At this time, ablation can be performed on specific area tissues. It can be understood that the ablation part 30 is fixedly connected to the distal end of the sealing part 10 and the proximal end of the anchoring part 20.

[0119] In yet another implementation manner, the first sub-electrodes 321 are divided into two groups, one group is connected to one pole of the pulse source, and the other group is connected to the other pole of the pulse source. At this time, only the area near the sealing part 10 in the left atrial appendage is ablated. And preferably, any two adjacent first sub-electrodes 321 are connected to different poles of the pulse source. It can be understood that the ablation part 30 is fixedly connected to the distal end of the sealing part 10.

[0120] In yet another implementation manner, the second sub-electrodes 331 are divided into two groups, one group is connected to one pole of the pulse source, and the other group is connected to the other pole of the pulse source. At this time, only the area near the anchoring part 20 in the left atrial appendage is ablated. And preferably, any two adjacent second sub-electrodes 331 are connected to different poles of the pulse source. It can be understood that the ablation part 30 is fixedly connected to the proximal end of the anchoring part 20.

[0121] More preferably, as in the third embodiment, before ablation, the electrode can also be connected to an electrocardiogram synchronizer to collect intracardiac electrical signals using the electrocardiogram synchronizer, so that the pulse output is in the absolute refractory period, thus not interfering with the heart rate and reducing sudden arrhythmia. After ablation, intracardiac electrical signals are collected to detect whether the inner wall of the left atrial appendage is completely destroyed by abnormal electrophysiological cell tissue, so as to ensure that the treatment can eliminate arrhythmia and restore sinus rhythm.

[0122] Fifth Embodiment:

[0123] As Figure 8 shown, an embodiment of the present invention provides a plugging and ablation device, an open support framework 31 integrally formed by laser cutting a nitinol metal tube, which fits against the inner wall of the left atrial appendage. The support framework 31 includes a connection end 50, a sealing portion 10, and an anchoring portion 20 fixedly connected in sequence from the proximal end to the distal end. The ablation portion 30 is integrally formed with the anchoring portion 20, and the distal end of the anchoring portion has an open structure. To increase the sealing effect, at least one layer of flow-blocking film 13 is sutured inside or outside the framework of the sealing portion 10 for plugging the orifice of the left atrial appendage.

[0124] An electrode is provided on the ablation portion 30, and the electrode includes a first electrode 32 and a second electrode 33; the connection method between the electrode and the support framework is the same as the wire fixing method in the first and second embodiments, which will not be elaborated here. The part of the support framework 31 in contact with the electrode is coated with parylene insulation treatment to prevent the electrode from being electrically connected to the metal framework and causing energy loss. As Figure 10 shown, both the first electrode 32 and the second electrode 33 are semi-circular platinum wires that surround half of the ablation portion 30, and the two form a circle. The first electrode 32 and the second electrode 33 are respectively connected to the positive and negative poles of the pulsed electric field, so that the current flows from one electrode to the other electrode through the radial outer path, thereby forming an annular ablation region. The two are combined to form a complete circle but are insulated from each other. The advantage of this electrode form is that the electric field diverges more outward, making it easier for the electric field to penetrate the inner wall of the left atrial appendage, thus making the treatment more thorough.

[0125] As Figure 9 shown, in this embodiment, the metal cutting framework is an integral body of the sealing portion 10, the ablation portion 30, and the anchoring portion 20. Two metal wires, namely the first electrode 32 and the second electrode 33, are provided on the ablation portion 30 and fixed to the outer surface of the support framework 31. As Figure 10 shown, the forms of both the first electrode 32 and the second electrode 33 are semi-circular. Of course, the first electrode 32 and the second electrode 33 in this embodiment can also be set to any arc shape, and the two are arranged symmetrically with respect to the center of the circle. The first electrode 32 and the second electrode 33 are respectively connected to the positive and negative poles of the pulsed electric field, so that the current flows from one electrode to the other electrode through the radial outer path, thereby forming an annular ablation region.

[0126] The above has introduced the embodiments of the present invention in detail. Specific examples are used in this text to elaborate on the principles and implementation manners of the present invention. The description of the above embodiments is only used to help understand the method and its core idea of the present invention. Various deformations and mutual combinations of the embodiments all fall within the scope of the present invention; at the same time, for those of ordinary skill in the art, according to the idea of the present invention, there will be changes in the specific implementation manners and application scopes. In summary, the content of this specification should not be construed as a limitation to the present invention.

Claims

1. A blocking ablation device, characterized in that, Comprising a support framework that fits against the inner wall of the left atrial appendage; The support framework includes an anchoring portion, a sealing portion, a connection end, and an ablation portion. The ablation portion is provided with electrodes, and the connection end is fixedly connected to the proximal end of the sealing portion; The electrodes include at least one first electrode and one second electrode; the first electrode and the second electrode are respectively connected to two poles of a pulse source; The electrodes can transmit high-voltage pulse energy to form an annular ablation region; The ablation portion further includes a first transmission wire. One end of the first transmission wire is connected to the first electrode, and the other end of the first transmission wire is used to connect to one pole of the pulse source; The ablation portion further includes a second transmission wire. One end of the second transmission wire is connected to the second electrode, and the other end of the second transmission wire is used to connect to the other pole of the pulse source; The first electrode includes a plurality of first sub-electrodes, and the second electrode includes a plurality of second sub-electrodes; Each of the first sub-electrodes is connected to one of the first transmission wires, and each of the second sub-electrodes is connected to one of the second transmission wires; The first sub-electrodes, the second sub-electrodes, and the first transmission wires and the second transmission wires respectively connected thereto are all fixed on a fixed sheath. The fixed sheath is a hollow structure made of a flexible insulating material; The fixed sheath includes an extension sheath and an annular sheath that at least surrounds the support framework once. The annular sheath is fixedly connected to the support framework; one end of the extension sheath is fixedly connected to the annular sheath; The first sub-electrodes and the second sub-electrodes are both fixed on the annular sheath. One end of the first transmission wire is fixedly connected to the first sub-electrode, and the other end of the first transmission wire passes through the annular sheath and extends into the extension sheath; One end of the second transmission wire is fixedly connected to the second sub-electrode, and the other end of the second transmission wire passes through the annular sheath and extends into the extension sheath.

2. The plugging ablation device according to claim 1, wherein The first electrode and the second electrode are both one of a metal wire or a metal sheet; or: The first electrode is a metal wire or a metal sheet, and the second electrode is an electrically exposed area of the support framework.

3. The plugging ablation device according to claim 2, wherein, The metal wire is any one of a serrated shape, a straight shape, or a spring shape.

4. The plugging and ablation device according to claim 1, wherein, The first electrode and the second electrode surround the outer periphery of the support framework in a ring shape, or surround half of the outer periphery of the support framework in a semi-ring shape, or surround a part of the outer periphery of the support framework in an arc shape.

5. The plugging ablation device according to claim 2, wherein, The electrically exposed area is electrically connected to the pulse source through the support framework and the connection end.

6. The plugging ablation device according to claim 1, wherein The outer layers of the support framework, the connection end, the first transmission wire, and the second transmission wire are all insulated.

7. The plugging ablation device according to claim 1, characterized in that, The first electrode and the second electrode share one fixed sheath, and the first sub-electrodes and the second sub-electrodes are fixedly arranged at intervals and crosswise on the outer side of the same annular sheath; Or the first electrode and the second electrode each use one fixed sheath. The first sub-electrodes are fixedly arranged at intervals on the outer side of the corresponding annular sheath, and the second sub-electrodes are fixedly arranged at intervals on the outer side of the corresponding annular sheath.

8. The plugging ablation device according to claim 7, wherein When the first electrode and the second electrode share one fixed sheath tube, the first sub-electrodes and the second sub-electrodes are alternately and equally spaced on the annular sheath tube. When the first electrode and the second electrode each use one fixed sheath tube, the first sub-electrodes are equally spaced on the annular sheath tube used by the first transmission wire, and the second sub-electrodes are equally spaced on the annular sheath tube used by the second transmission wire.

9. The plugging ablation device according to claim 1, wherein Both the first sub-electrodes and the second sub-electrodes are sub-metal sheets; the shape of the sub-metal sheet is any one of L-shaped, strip-shaped, circular or triangular.

10. The occlusion ablation device according to any one of claims 1 to 9, characterized in that, Part or all of the electrode is detachably connected to the support skeleton, and the part of the electrode detachably connected to the support skeleton can be withdrawn from the body by an external force.

11. The occlusion ablation device according to any one of claims 1 to 9, characterized in that, The support skeleton is a grid-shaped skeleton made of elastic metal wire weaving or elastic metal laser cutting and heat setting.

12. The occlusive ablation device according to any one of claims 1 to 9, characterized in that, The electrode is made of any one of platinum, platinum-iridium alloy, gold, nitinol or stainless steel.

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