WO2021218549A1

WO2021218549A1 - Ablation and blocking device

Info

Publication number: WO2021218549A1
Application number: PCT/CN2021/084415
Authority: WO
Inventors: 王坤; 王永胜
Original assignee: 杭州德诺电生理医疗科技有限公司
Priority date: 2020-04-30
Filing date: 2021-03-31
Publication date: 2021-11-04

Abstract

An ablation and blocking device, comprising a blocking member and an energy processing system, and further comprising a multi-electrode assembly (50) provided on the blocking member. The multi-electrode assembly is connected to the energy processing system; the multi-electrode assembly comprises a plurality of electrode units (52), at least some of the electrode units are used to ablate a target tissue region, and at least some of the electrode units are used to monitor an electrophysiological signal of the target tissue region.

Description

Ablation blocking device

Technical field

This application relates to the technical field of interventional medical devices, and relates to an ablation blocking device for blocking ablation of the left atrial appendage. The ablation blocking device uses a percutaneous puncture method to deliver it to the position of the left atrial appendage of the heart through a delivery sheath. , In order to transfer energy to the left atrial appendage for ablation, receive physiological signals and block.

Background technique

Atrial fibrillation (abbreviated as atrial fibrillation) is the most common persistent arrhythmia. With age, the incidence of atrial fibrillation continues to increase, reaching 10% of people over 75 years of age. In atrial fibrillation, the frequency of atrial activation is 300-600 beats/min. The heartbeat frequency is often fast and irregular, sometimes up to 100-160 beats/min. Not only is the heartbeat much faster than normal people, but it is absolutely irregular and the atria is lost. Effective contraction function. The prevalence of atrial fibrillation is also closely related to diseases such as coronary heart disease, hypertension and heart failure.

The left atrial appendage (LAA) is not only the most important part of thrombus formation in atrial fibrillation (atrial fibrillation) due to its special shape and structure, but also one of the key areas for its occurrence and maintenance. Some patients with atrial fibrillation can be active Electrical isolation (left atrial appendage isolation, LAAI) benefits.

On the one hand, the percutaneous left atrial appendage occlusion device uses a special occluder to occlude the left atrial appendage, thereby achieving the purpose of preventing atrial fibrillation and thromboembolism. It has been developed in recent years with less trauma, simple operation and less time-consuming Treatment methods. At present, many scholars are committed to the application of this technology to prevent thromboembolism in atrial fibrillation and have made great progress. The basic structure of the current left atrial appendage occlusion and ablation device is similar, that is, the outer cover of the self-expanding nickel-titanium memory alloy cage structure stent is covered with an expandable polymer film, and the rod of the nickel-titanium alloy stent has an anchor hook (similar to The barbs on the hook) can help fix the device in the auricle so as not to fall off. The high molecular polymer film can seal the left atrial appendage atrium entrance, isolate the left atrial appendage and the left atrium body, and prevent blood flow. After the occluder is placed in the left atrial appendage, the left atrial endothelial cells will crawl and grow on the surface of the polymer membrane, and a new endothelium will be formed after a period of time. However, simple LAA closure can only prevent stroke, but cannot improve the symptoms of atrial fibrillation.

On the other hand, the electrical isolation of the left atrial appendage is one of the hotspots in the treatment of atrial fibrillation today. Ablation treatment includes many aspects, such as pulse ablation, radiofrequency ablation, laser ablation, microwave ablation, thermal material ablation, cryoablation, etc.; from the overall perspective of atrial fibrillation treatment, sinus rhythm restoration and stroke prevention are two parallel treatment strategies , Its importance is equal. At present, some cardiovascular experts have successfully treated cases of atrial fibrillation by combining catheter ablation and left atrial appendage occlusion at the same time. Combined treatment strategy: After the left atrial appendage closure, compared with a single oral anticoagulant or atrial fibrillation ablation, the patient can still obtain a good stroke prevention effect without taking anticoagulant drugs for life; combined with catheter ablation recovery And maintain sinus rhythm to improve the symptoms of patients with atrial fibrillation, so that patients can obtain stable long-term treatment effects. However, this combined treatment method requires the use of two instruments, namely the left atrial appendage occlusion and ablation device and the ablation catheter, which are cumbersome to operate; and the operation is often faced with incomplete ablation and cannot achieve complete electrical isolation of the inner wall of the left atrial appendage. The effect is difficult to maintain long-term curative effect. Therefore, in the ablation process, improving the adhesion of the ablation piece to the inner wall of the left atrial appendage and the ability to detect whether the electrical isolation is complete is critical to ensuring the electrical isolation effect.

Summary of the invention

In view of this, the purpose of the present application is to provide an ablation blocking device that can simultaneously block and ablate the left atrial appendage. Ablation efficiency of the inner wall of the auricle.

In order to solve the above technical problems, the present application provides an ablation occlusion device, including an occlusion member and an energy processing system, characterized in that the ablation occlusion device further includes a multi-electrode assembly arranged on the occlusion member The multi-electrode assembly is connected to the energy processing system; the multi-electrode assembly includes a plurality of electrode units, at least some of the electrode units are used to ablate the target tissue area, and at least some of the electrode units are used to monitor the electrical energy of the target tissue area. Physiological signals.

The multiple electrode units of the ablation and occlusion device of the present application are arranged at intervals along the length direction of the multi-electrode assembly, the multiple electrode units correspond to the inner wall of the left atrial appendage, and the multiple electrode units are electrically connected to the energy processing system through wires for Transmit energy and receive signals; therefore, multiple electrode units can selectively perform targeted ablation and monitoring of the designated area on the inner wall of the left atrial appendage; at the same time, the occluder can block the entrance of the left atrial appendage, thereby enabling the ablation and occlusion device It can effectively block the entrance of the left atrial appendage and improve the ablation efficiency of the inner wall of the left atrial appendage.

Description of the drawings

In order to explain the technical solutions of the embodiments of the present application more clearly, the following will briefly introduce the drawings that need to be used in the embodiments. Obviously, the drawings in the following description are some embodiments of the present application, which are common in the field. As far as technical personnel are concerned, they can also obtain other drawings based on these drawings without creative work.

FIG. 1 is a schematic diagram of the structure of the ablation occlusion device provided by the first embodiment of the present application;

Figure 2 is a top view of the ablation occlusion device provided by the first embodiment of the present application;

FIG. 3 is a diagram of a state where the ablation occlusion device provided in the first embodiment of the present application is released in the left atrial appendage;

4 is a schematic structural diagram of the ablation and occlusion device provided by the second embodiment of the present application;

5 is a schematic diagram of the structure of one of the electrode units and the carrier member of the ablation and occlusion device in FIG. 4;

Fig. 6 is a state diagram of the ablation occlusion device provided in the second embodiment of the present application released in the left atrial appendage;

FIG. 7 is a schematic structural diagram of the first embodiment of the ablation and occlusion device provided by the third embodiment of the present application; FIG.

Fig. 8 is a schematic structural diagram of a second embodiment of the ablation and occlusion device provided by the third embodiment of the present application.

Detailed ways

The technical solutions in the embodiments of the present application will be clearly and completely described below in conjunction with the accompanying drawings in the embodiments of the present application. Obviously, the described embodiments are only a part of the embodiments of the present application, rather than all the embodiments. Based on the embodiments in this application, all other embodiments obtained by a person of ordinary skill in the art without creative work shall fall within the protection scope of this application.

In the description of this application, it should be noted that the orientation or positional relationship indicated by the terms "upper", "lower", "inner", "outer" etc. is based on the orientation or positional relationship shown in the drawings, and is only for It is convenient to describe the application and simplify the description, but does not indicate or imply that the device or element referred to must have a specific orientation, be configured and operated in a specific orientation, and therefore cannot be understood as a limitation of the application. In addition, the terms "first", "second", etc. are only used for descriptive purposes, and cannot be understood as indicating or implying relative importance.

In order to more clearly describe the structure of the wire locking system and the wire locking device, the limited terms "proximal", "distal" and "axial" described in this application are common terms in the field of interventional medicine. Specifically, "distal" refers to the end far away from the operator during the surgical operation; "proximal end" refers to the end close to the operator during the surgical operation; the proximal end in this application is relative to the distal end from the operator ( The distance between the surgeon) is relatively short. After the device is assembled, each component of the device includes a proximal end and a distal end, and the proximal end of each component is closer to the operator than the distal end. "Axial" refers to the direction of the central axis of the device, and the radial direction is the direction perpendicular to the central axis. Unless otherwise defined, all technical and scientific terms used in this application have the same meaning as commonly understood by those skilled in the technical field of this application. Conventional terms used in the specification of this application are only for the purpose of describing specific embodiments, and should not be construed as limiting the application.

It should be noted that when an element is referred to as being "fixed to" or "installed on" another element, the element can be directly connected to the other element, or indirectly connected to the other element through one or more connecting elements. On one component. When an element is said to be "connected to" another element, it can be directly connected to the other element or connected to the other element through one or more connecting elements.

Please refer to FIGS. 1 to 3 together. FIG. 1 is a schematic structural diagram of the ablation and occlusion device 100 provided by the first embodiment of the present application; FIG. 2 is a top view of the ablation and occlusion device 100 provided by the first embodiment of the present application; 3 is a state diagram of the ablation occlusion device 100 provided in the first embodiment of the present application released in the left atrial appendage 305. The present application provides an ablation blocking device 100, which includes a blocking member 20 for sealing the entrance 306 of the left atrial appendage 305, and a multi-electrode assembly 50 provided on the outer wall of the blocking member 20. The multi-electrode assembly 50 includes a plurality of electrode units 52. The plurality of electrode units 52 are arranged at intervals along the length of the multi-electrode assembly 50. The plurality of electrode units 52 are used to transmit energy and receive signals, and at least part of the electrode units 52 are used to ablate target tissues. And at least part of the electrode unit 52 is used to monitor the electrophysiological signal of the target tissue. Optionally, perform directional ablation of a designated area on the inner wall of the left atrial appendage 305 and monitor electrophysiological signals.

The multiple electrode units 52 of the ablation and occlusion device 100 of the present application are arranged at intervals along the length direction of the multi-electrode assembly 50. The multiple electrode units 52 correspond to the inner wall of the left atrial appendage 305, and the multiple electrode units 52 are electrically connected to the energy treatment by conductive wires. System; therefore, multiple electrode units 52 can selectively perform targeted ablation and monitoring of the designated area on the inner wall of the left atrial appendage 305; at the same time, the occluder 20 can block the entrance 306 of the left atrial appendage 305, so as to block the ablation The device 100 can not only effectively block the entrance of the left atrial appendage 305 but also improve the ablation efficiency of the inner wall of the left atrial appendage 305.

The blocking member 20 includes a supporting frame 22 fitted to the inner wall of the left atrial appendage 305; the blocking member 20 is used to block and separate the left atrium 302 and the left atrial appendage 305 to prevent the thrombus in the left atrial appendage 305 from entering the left atrium 302. At least part of the plurality of electrode units 52 may be electrically connected to the energy processing system one-to-one through the same number of mutually insulated conductive wires. The occlusion member 20 and the multi-electrode assembly 50 of the ablation occlusion device 100 in FIGS. 1 to 3 are both in a free state, that is, the ablation occlusion device 100 is implanted in the entrance 306 of the left atrial appendage 305. In order to facilitate the delivery, both the blocking member 20 and the multi-electrode assembly 50 can be compressed and reduced in diameter in the radial direction to be accommodated in the sheath.

The support frame 22 can be made of elastic metal or polymer material. In this embodiment, it is made of metal wire woven, and it can be a radially compressed grid-like structure, a rod-like structure, a frame structure or a flexible foldable structure, etc. Metal pipes can also be cut to form a grid or frame structure. The metal wire can be nickel-titanium alloy, cobalt-chromium alloy, stainless steel or other metal materials with good biocompatibility, preferably super-elastic shape memory alloy nickel-titanium wire, and its manufacturing process is the same as that of traditional left atrial appendage occluder. The same, so I won't repeat them here.

The support frame 22 generally has a cylindrical structure. Specifically, the support frame 22 can be a cylindrical structure, a truncated cone-shaped structure, a conical structure, or a combination thereof. All of these structures have an outer wall surface that fits the inner wall of the left atrial appendage 305. In addition to the above regular structure, the support frame 22 can also be an irregular structure with a partial ring attached to the inner wall surface of the left atrial appendage 305, and this partial ring also has an outer wall surface that is attached to the inner wall of the left atrial appendage 305. In this embodiment, the support skeleton 22 adopts a grid-like cylindrical structure.

The blocking member 20 includes a sealing portion 221, a connecting portion 223 and an anchoring portion 225. The sealing portion 221 is located at the proximal end of the blocking member 20 and is used to close the entrance 306 of the left atrial appendage 305; the anchoring portion 225 is located at the end of the blocking member 20. The distal end is used to anchor the ablation occlusion device 100 in the left atrial appendage 305; the connecting part 223 is located between the sealing part 221 and the anchoring part 223, and is used to connect the sealing part 221 and the anchoring part 225, the multi-electrode assembly 50 Set on the connecting part 223. In this embodiment, the multi-electrode assembly 50 surrounds the outer wall surface of the connecting portion 223, so that the plurality of electrode units 52 can be attached to the inner wall of the left atrial appendage 305 that needs to be ablated.

The sealing portion 221 includes a grid frame 2212 that supports the proximal part of the skeleton 22, at least one layer of baffle film 2214 arranged in the grid frame 2212, and a connecting end 2215 located in the middle of the proximal end of the grid frame 2212 . The shape of the sealing portion 221 may be a disc shape, a cylindrical shape, or a stepped shape formed by a combination of a disc shape and a cylindrical shape, or the like. In this embodiment, the shape of the sealing portion 221 is cylindrical, and the mesh frame 2212 is woven from superelastic shape memory alloy nickel-titanium wire; the diameter of the mesh frame 2212 is consistent with the inner diameter of the left atrial appendage 305, and the mesh frame 2212 is The frame 2212 can be inserted into the neck of the left atrial appendage 305, and the outer wall surface of the grid frame 2212 is attached to the inner wall of the neck of the left atrial appendage 305.

At least one layer of baffle film 2214 is provided inside and/or outside the proximal end and/or distal end of the blocking member 20. In this embodiment, the sealing portion 221 realizes the sealing of the entrance 306 of the left atrial appendage 305 by providing a baffle film 2214 inside. The baffle film 2214 can be fixed to the inside of the grid frame 2212 by stitching or bonding, and the baffle film 2214 can be selected from PET or PTFE film.

The connecting end 2215 is located at the center of the end surface of the proximal end of the support frame 22, that is, the connecting end 2215 is constricted at the head end of the metal wire on the proximal end surface of the support frame 22. The connecting end 2215 preferably uses an axially hollow bolt head, and the connecting end 2215 is used for detachable connection with the conveyor. In this embodiment, the distal end of the multi-electrode assembly 50 passes through the connecting end 2215 to surround the connecting portion 223 of the support frame 22, and the proximal end of the multi-electrode assembly 50 passes through the conveyor to be electrically connected to the energy processing system.

The connecting portion 223 includes a grid frame 2232 between the sealing portion 221 and the anchoring portion 225 of the supporting frame 22, and at least one layer of baffle film 2234 arranged in the grid frame 2232. The shape of the mesh frame body 2232 is cylindrical, and the mesh frame body 2232 is woven with metal wires to form a grid shape that crosses each other. The distal end of the multi-electrode assembly 50 surrounds the outer wall of the grid frame 2232. Specifically, the multi-electrode assembly 50 surrounds at least one circle along the annular outer wall surface of the grid frame 2232. In this embodiment, the multi-electrode assembly 50 surrounds three circles along the annular outer wall surface of the grid frame 2232. The multi-electrode assembly 50 can be installed on the outer wall of the grid frame 2232 by stitching or winding.

The anchoring portion 225 includes an anchoring body 2252 that supports the distal end of the skeleton 22, at least one layer of baffle film 2254 provided in the anchoring body 2252, a number of anchors 2255, and a seal located at the distal end of the anchoring body 2252. Head 2257. The anchoring body 2252 is a cylindrical structure, preferably a cylindrical structure, that is, the diameter of the anchoring body 2252 is basically the same as the inner diameter of the left atrial appendage 305, and friction is formed between the outer wall surface of the anchoring body 2252 and the inner wall of the left atrial appendage 305. The anchoring body 2252 can be directly used to anchor the ablation and occlusion device 100.

Further, the anchor body 2252 is provided with a plurality of anchors 2255 for anchoring on the inner wall of the left atrial appendage 50, the anchors 2255 are evenly arranged in a circle on the outer wall of the anchor body 2252, and the ablation and occlusion device 100 is implanted Later, the anchor 2255 pierces the inner wall of the left atrial appendage 305 to further anchor the ablation and occlusion device 100. The anchor 2255 is used for better anchoring stability and prevents the ablation and occlusion device 100 from falling off. The distal end of the anchor body 2252 of the cylindrical structure is closed, and the proximal end is integrated with the connecting portion 223.

The baffle membrane 2254 is radially arranged in the anchor body 2252, the periphery of the baffle membrane 2254 is fixed to the inside of the anchor body 2252 by stitching or bonding, and the baffle membrane 2254 is a PET or PTFE film. In this embodiment, the anchor body 2252 is radially provided with two spaced-apart baffle films 2254.

The anchor 2255 and the anchor main body 2252 are an integral structure or a fixed connection structure. In this embodiment, a steel sleeve is used to connect the anchor 2255 and the anchor main body 2252 together. The anchor 2255 is located at the far end of the support frame 22, and the number is 6-20. The opening angle of the anchor 2255 is between 30° and 60°, and the direction is toward the proximal end, and the length of the anchor 2255 is between 0.5 and 4mm. The head 2257 is located at the center of the distal end surface of the anchoring portion 225, that is, the head 2257 is constricted at the end of the metal wire supporting the distal end surface of the skeleton 22. The anchoring portion 225 is provided with a barbed structure, which is mainly used to strengthen and stabilize the entire ablation and occlusion device 100.

In this embodiment, the sealing portion 221, the connecting portion 223, and the anchoring portion 225 are an integral structure, that is, the mesh frame 2212 of the sealing portion 221, the mesh frame 2232 of the connecting portion 223, and the anchoring of the anchoring portion 225 The main body 2252 may be integrally formed to form the above-mentioned support frame 22, or may be connected to the above-mentioned integrally formed support frame 22 by means of welding or the like.

The multi-electrode assembly 50 also includes a carrier member 53 which is a tubular structure supported by a flexible insulating material. Specifically, the carrier member 53 is a hollow tube made of a flexible insulating material, such as a block polyetheramide resin. Hollow tube. The carrier member 53 can accommodate sensor wires such as conductive wires or thermocouple wires. The carrier member 53 is arranged outside the blocking member 20 by binding, pasting or sewing; specifically, the carrier member 53 is arranged on the outer peripheral surface of the supporting frame 22. The carrier member 53 includes at least one surrounding section circumferentially surrounding the outer surface of the blocking member 20, and a plurality of electrode units 52 are disposed on the surrounding section of the carrier member 53 and arranged uniformly along the length direction of the surrounding section. At least a part of the electrode units 52 on the surrounding section of at least one circle are connected to the energy processing system through a one-to-one connection of independent conductive wires. Specifically, each electrode unit 52 is connected to a conductive wire, and each electrode unit 52 is connected to the carrier member. A small hole is provided between 53 and each conductive wire is accommodated in the inner cavity of the carrier member 53, and passes through the small hole and runs along the extending direction of the carrier member 53, and is connected to the energy processing system. Specifically, the electrode units 52 are all welded to a conductive wire, the outer surface of the conductive wire is insulated, and the proximal end of the conductive wire extends along the inner cavity of the carrier member 53 to be connected to the energy processing system. The energy processing system at least includes an energy generator and a multi-channel physiological recorder.

Each electrode unit 52 is an electrode sheet arranged outside the carrier member 53, and the shape of the electrode sheet is any one of a flat surface, a curled shape, or a folded shape; the folded shape is like a letter "W" shape, an "L" shape electrode piece. The electrode unit 52 is made of any one of platinum, platinum-iridium alloy, gold, nickel-titanium alloy or stainless steel; in this embodiment, the electrode sheet is in a closed crimp shape, and each electrode unit 52 is an electrode ring with good conductivity. The electrode ring is sleeved on the outer peripheral surface of the carrier member 53, and the electrode ring is a platinum iridium electrode ring.

In this embodiment, the carrier member 53 surrounds three loops along the outer surface of the connecting portion 223 circumferentially. The three loops are arranged in parallel and spaced apart by the multi-electrode assembly 50, from the distal end to the proximal end of the connecting portion 223, respectively. These are the first electrode group 54, the second electrode group 55, and the third electrode group 56. The first electrode group 54, the second electrode group 55 and the third electrode group 56 are respectively provided with a number of electrode units 52 along the length direction, and each electrode unit 52 is an iridium electrode ring with good conductivity.

In this embodiment, when the multi-electrode assembly 50 just starts to work, its adherence to the inner wall of the left atrial appendage can be monitored. Each electrode unit 52 uses the micro current emitted by the energy generator to perform a test on the tissue contacted by each electrode unit 52. Impedance calculation shows that the impedance value of the electrode unit 52 is positively correlated with the adhesion between the electrode unit 52 and the inner wall tissue of the left atrial appendage. Therefore, the impedance value of all the electrode units 52 can be compared from the first electrode group 54 and the second electrode group. In group 55 and the third electrode group 56, the electrode group with the best adhesion is selected to ablate the inner wall of the left atrial appendage. After the ablation, the multi-electrode assembly 50 can monitor the potential signal of the inner wall tissue of the left atrial appendage. Each electrode unit 52 can receive the ECG signal of the tissue area attached to it, and transmit it to the multi-conductor physiological recorder through the conductive wire. The lead physiological recorder shows whether there is a potential signal in the inner wall tissue of the left atrial appendage. If it does not exist, it means that the multi-electrode assembly 50 has completely achieved the effect of electrical isolation for the ablation of the inner wall of the left atrial appendage; The effect of isolation.

The energy of the energy generator is any one of pulse, radio frequency, and microwave. In this embodiment, the energy generator is a radio frequency generator. When the multi-electrode assembly 50 turns on the radio frequency ablation function, any part of the electrode unit 52 can be used as an output The electrode can also be used as a ground electrode. Therefore, the electrode unit 52 array has a variety of power connection methods, and the operating end of the radio frequency generator can be oriented to select the ablation area according to needs, including but not limited to the following methods:

One of the first electrode group 54, the second electrode group 55 and the third electrode group 56 is connected to the energy output terminal, and two of the first electrode group 54, the second electrode group 55 and the third electrode group 56 are grounded ; For example, the first electrode group 54 is connected to the energy output terminal, the second electrode group 55 and the third electrode group 56 are grounded; that is, the electrode units 52 on the first electrode group 54 are output electrodes, the second electrode group 55 and the third The electrode units 52 of the electrode group 56 are all ground electrodes.

Two of the first electrode group 54, the second electrode group 55 and the third electrode group 56 are connected to the energy output terminal, and one of the first electrode group 54, the second electrode group 55 and the third electrode group 56 is grounded ; For example, the first electrode group 54 and the second electrode group 55 are connected to the energy output terminal, and the third electrode group 56 is grounded; that is, the electrode units 52 on the first electrode group 54 and the second electrode group 55 are output electrodes, the third The electrode units 52 of the electrode group 56 are all ground electrodes.

One of the first electrode group 54, the second electrode group 55 and the third electrode group 56 is connected to the energy output terminal, and one of the first electrode group 54, the second electrode group 55 and the third electrode group 56 is grounded , One of the first electrode group 54, the second electrode group 55 and the third electrode group 56 is empty; for example, the first electrode group 55 is connected to the energy output terminal, the second electrode group 55 is grounded, and the third electrode group 56 is empty; That is, the electrode unit 52 on the first electrode group 54 is an output electrode, the electrode unit 52 of the second electrode group 55 is a ground electrode, and the electrode unit 52 of the third electrode group 56 is empty.

One of the first electrode group 54, the second electrode group 55, and the third electrode group 56 is connected to the energy output terminal at the odd-numbered position of the electrode unit 52 along its length. The first electrode group 54 and the second electrode group 55 One of the three electrode units 52 of the third electrode group 56 and the third electrode group 56 is grounded at even-numbered positions along its length, and two of the first electrode group 54, the second electrode group 55, and the third electrode group 56 are left empty. For example, the first electrode unit 541, the third electrode unit 543, the fifth electrode unit 545... and other electrode units in the odd-numbered positions of the electrode unit 52 in the first electrode group 55 in the order along its length direction are output electrodes; The second electrode unit 542, the fourth electrode unit 544, the sixth electrode unit 546, etc. in the even-numbered positions of the electrode unit 52 in the electrode group 55 in the sequence of the length direction are ground electrodes; the second electrode The group 55 and the third electrode group 56 are empty.

One or more of the electrode units 52 in one of the first electrode group 54, the second electrode group 55, and the third electrode group 56 is connected to the energy output terminal. The first electrode group 54, the second electrode group 55, and the One or more of the electrode units 52 in one of the three electrode groups 56 are grounded, and the other electrode units 52 are left empty; for example, the second electrode unit 552 in the second electrode group 55 is an output electrode, and the third electrode group 56 is The second electrode unit 572 of is a ground electrode, and all other electrode units 52 are left empty.

At least part of the electrode unit 52 is used to ablate the target tissue, and at least part of the electrode unit 52 is used to monitor electrophysiological signals of the target tissue. The electrode unit 52 array is independent of each other and has functions such as ablation and ECG signal collection. It can freely detect ECG signals in different regions, combine the monitoring signals to perform directional ablation of any region, and set different ablation parameters in different regions. Therefore, the monitoring function and ablation function of the electrode array can be performed step by step or simultaneously, including but not limited to the following methods:

1. Two of the first electrode group 54, the second electrode group 55 and the third electrode group 56 are connected to the radio frequency generator, and one of the first electrode group 54, the second electrode group 55 and the third electrode group 56 A multi-lead physiological recorder is connected; for example, the third electrode group 56 and the second electrode group 55 are connected to a radio frequency generator, and the first electrode group 54 is connected to a multi-lead physiological recorder to monitor the potential signal at the orifice of the left atrial appendage; The three electrode group 56 and the second electrode group 55 are ablation electrodes, and the first electrode group 54 is a monitoring electrode. The two electrodes are performed at the same time until the monitoring electrode cannot detect the potential to achieve the effect of electrical isolation, and the ablation is stopped.

2. The energy processing system is equipped with a filter. All electrode units 52 are connected to the radio frequency generator and the multi-conductor physiological recorder at the same time. The filter transmits different waves on the same conductive wire to the radio frequency generator and the multi-conductor physiological recorder. , Where the RF generator is equipped with an impedance detection module, each electrode unit 52 can perform at least three functions of monitoring adhesion, monitoring potential, and ablation at the same time; the energy processing system can be set up with a software program to set the relationship between the three functions, For example, the ablation efficiency of the inner wall of the left atrial appendage by the multi-electrode assembly 50 can be improved by directional ablation for the area with good adhesion and the area where the electric potential signal is not electrically isolated.

The energy processing system can also be provided with a three-dimensional mapping system connected to the conductive wire, and draw three-dimensional anatomical diagrams, activation sequence diagrams, voltage diagrams, etc. by collecting electrical signals.

As shown in FIG. 3, the ablation occlusion device 100 provided in the first embodiment of the present application is released in the left atrial appendage 305. During the operation, the connecting end 2215 on the sealing portion 221 can be connected to the delivery sheath 70 by means of bolts, and received into a delivery sheath 80 with a smaller diameter, and then enter the inferior vena cava 301 through femoral vein puncture and enter the right atrium 303 , And then enter the left atrium 302 through atrial septal puncture. When the ablation occlusion device 100 is released, the position of the ablation occlusion device 100 in the left atrial appendage 305 is positioned by contrast and ultrasound to ensure that the anchor portion 225 is released inside the left atrial appendage 305 after release, and the anchor 2255 hooks into the left atrial appendage 305 The inner wall of the inner wall; the outer wall surface of the connecting portion 223 closely fits the inner wall of the left atrial appendage 305 near the entrance 306, and the baffle film 2214 in the sealing portion 221 blocks the entrance 306 of the left atrial appendage 305 to prevent blood flow into the left atrial appendage 305 The thrombus in the inner and left atrial appendage 305 flows into the left atrium 302. After the ablation occlusion device 100 is released in the left atrial appendage 305, the energy processing system turns on the adhesion detection function of the multi-electrode assembly 50, and selects the electrode group with good adhesion through the software program to turn on the radiofrequency ablation function and simultaneously turns on the multi-electrode assembly 50 The electric potential signal detection function of the radio frequency ablation of the cells can cause cell apoptosis, and achieve the effect of electrical isolation of the inner wall of the left atrial appendage 305. After the ablation is completed, the multi-electrode assembly 50 can be detached from the support frame 22. Specifically, a certain amount of pulling force is applied to the carrier member 53 to separate the carrier member 53 from the support frame 22 and withdraw from the body. After the ablation operation is completed, the delivery sheath 70 is released from the blocking member 20, and the blocking member 20 is left in the left atrial appendage 305 to achieve long-term blocking performance. The ablation occlusion device 100 provided in the present application can use the structure of the ablation occlusion device 100 to successively block the entrance 306 of the left atrial appendage 305 and efficiently realize the complete ablation and blocking of the inner wall of the left atrial appendage 305 in one operation. Thereby restoring sinus rhythm.

In other embodiments, the multi-electrode assembly 50 surrounds two surrounding segments in the circumferential direction of the outer surface of the support frame 22. The electrode unit 52 on the surrounding section in one circle is connected to the energy output end of the radio frequency generator, and the electrode unit 52 on the surrounding section in the other circle is grounded; or, at least one electrode on the surrounding section in one circle The unit 52 is connected to the energy output end of the radio frequency generator, and at least one electrode unit 52 on the other surrounding section is grounded.

In other embodiments, the multi-electrode assembly 50 surrounds more than three circles in the circumferential direction of the outer surface of the support frame 22. At least one of the electrode units 52 on the surrounding segment is connected to the energy output end of the radio frequency generator, and at least another of the electrode units 52 on the surrounding segment is grounded.

In other embodiments, the multi-electrode assembly 50 surrounds a circle around the circumference of the outer surface of the support frame 22. At least one electrode unit 52 on the surrounding section is connected to the energy output end of the radio frequency generator, and at least another electrode unit 52 is grounded.

Please refer to FIGS. 4 to 6 together. FIG. 4 is a schematic structural diagram of the ablation and occlusion device 100a provided by the second embodiment of the present application; FIG. 5 is one of the electrode units 52 and the carrier member of the ablation and occlusion device 100a in FIG. 4 53 is a schematic structural diagram; FIG. 6 is a state diagram of the ablation occlusion device 100a released in the left atrial appendage 305 according to the second embodiment of the present application. The structure of the ablation occlusion device 100a provided in the second embodiment of the present application is similar to the structure of the first embodiment, except for the structure and arrangement of the sealing portion 221a and the multi-electrode assembly 50 in the second embodiment. Specifically, the ablation and occlusion device 100a also includes a sealing portion 221a, a connecting portion 223, and an anchoring portion 225. The sealing portion 221a and the connecting portion 223 are connected by a connecting piece 60, and the connecting portion 223 and the anchoring portion 225 are integrated. Specifically, the support frame 22 of the ablation and occlusion device 100a has a double-disc structure, including a proximal disc and a distal disc. The proximal disc and the distal disc are connected by a connecting member 60; the proximal disc is braided and heat-set with nickel-titanium wire to form a sealing portion 221a for sealing the left atrial appendage 305; the distal disc includes a connecting portion The anchoring portion 223 and the anchoring portion 225 are also shaped by nickel-titanium braiding; the anchoring portion 225 is used to anchor the ablation occlusion device 100a in the left atrial appendage 305.

The mesh frame 2212 of the sealing portion 221 a is used to seal the entrance 306 of the left atrial appendage 305, and the mesh frame 2212 matches the shape of the entrance 306 of the left atrial appendage 305 to be consistent. As shown in FIG. 6, in this embodiment, the sealing portion 221a is pressed into the entrance 306 of the left atrial appendage 305, the diameter of the sealing portion 221a is slightly larger than the inner diameter of the entrance 306 of the left atrial appendage 305, and the grid frame 2212 adopts axial With a short disc-shaped structure, the grid frame 2212 can directly seal the entrance 306.

One or more baffle films 2214 are provided in the mesh structure 2212, and the proximal surface of the sealing portion 221a is provided with a connecting end 2215; the baffle film 2214 can be provided in the sealing portion 221a or on the outer surface of the sealing portion 221a The baffle film 2214 is covered with a layer of polymer, and the baffle film 2214 is preferably a PET or PTFE film. The connecting end 2215 is located at the center of the proximal disk surface of the grid structure 2212 and is used to connect the conveyor.

The connecting portion 223 is located at the proximal end of the telecentric disc. The connecting portion 223 includes a ring-shaped mesh frame body 2232. The outer wall surface of the grid frame body 2232 is provided with at least two multi-electrode assemblies 50. The connecting portion 223 surrounds at least one circle in the circumferential direction. The anchoring portion 225 is located at the distal end of the telecentric disc, and includes an anchoring body 2252, a baffle membrane 2254, an anchor 2255, and a head 2257. The periphery of the baffle membrane 2254 is fixed inside the anchor body 2252 by means of sutures. The grid structure 2212 of the sealing portion 221a and the grid frame 2232 of the connecting portion 223 are connected together by the connecting member 60, and can be connected together by welding or pressing. The connecting piece 60 adopts a columnar structure made of a metal conductive material, and the connecting piece 60 is arranged between the center of the end surface of the proximal end of the connecting portion 223 and the center of the end surface of the distal end of the sealing portion 221a.

In this embodiment, the ablation part of the ablation blocking device 100a is located between the sealing part 221a and the anchoring part 225. The ablation part includes a mesh frame 2232 between the sealing part 221a and the anchoring part 225, and At least two multi-electrode assemblies 50 outside the grid frame 2232. Each multi-electrode assembly 50 includes a carrier member 53 fixed on the outer surface of the connecting portion 223 and a plurality of electrode units 52 provided on the outer wall of the distal end of the carrier member 53. Each carrier member 53 includes at least one circle surrounding the outer surface of the connecting portion 223 along the circumferential direction of the support frame 22, and a plurality of electrode units 52 are uniformly arranged along the length direction of the surrounding section. Compared with all the electrode units 52 being arranged in the same carrier member 53, the carrier member of the multi-electrode assembly has a smaller diameter, thereby reducing the maximum diameter of the ablation and occlusion device 100a, and at the same time reduces the compression and loading of the ablation and occlusion device 100a on the conveyor Difficulty within.

As shown in FIG. 5, each electrode unit 52 includes an electrode sheet 523 and an insulating substrate 525 disposed on the back of the electrode sheet 523. The electrode sheet 523 is connected through the side wall of the carrier 53 and the substrate 525 through a conductive wire 526. The proximal end of the wire 526 extends along the carrier member 53 to the proximal connection end, and is connected to the energy processing system.

Each electrode sheet 523 is a plane of any shape, and each electrode sheet 523 has good conductivity; preferably, the electrode sheet 523 is a platinum iridium electrode sheet, and each substrate 525 has good insulation performance, such as a PTFE substrate. An elastic member 527 is arranged between the substrate 525 of each electrode unit 52 and the side wall of the carrier member 53, and a pull wire 528 is fixedly connected to the side of the substrate 525 facing the carrier member 53. The pull wire 528 passes through the rear edge of the side wall of the carrier member 53 The carrier member 53 extends to the operating handle, and by applying different forces to the pull wire 528 through the operating handle, the distance between the electrode sheet 523 and the carrier member 53 can be controlled, and the elastic member 527 is elastically deformed. In this embodiment, the elastic member 527 is a spring, one end of the spring is embedded in the base plate 525, and the other end of the spring is fixed to the carrier member 53. The material of the pull wire 528 can be made of a polymer material or a nickel-titanium alloy material. The combination of the elastic member and the electrode sheet increases the adhesion of each electrode unit 52 to the inner wall of the left atrial appendage and improves the accuracy of collecting the electrophysiological signals of the tissue cells.

The surgical process of the ablation and occlusion device 100a of the second embodiment of the present application is similar to that of the first embodiment, except that: when the ablation and occlusion device 100a is in the initial state, the pulling wire 528 is in a tight state, and the elastic member 527 is elastically deformed , The electrode sheet 523 is attached to the outer wall of the carrier member 53; when the ablation occlusion device 100a is ablated, the pull wire 528 is in a relaxed state, the elastic member 527 is elastically reset, and the electrode sheet 523 leaves the outer wall of the carrier member 53 and is close to the left atrial appendage 305 Inner wall.

Please refer to FIG. 7. FIG. 7 is a schematic structural diagram of a first embodiment of the ablation occlusion device 100 b provided by the third embodiment of the present application. The structure of the first embodiment of the ablation and occlusion device 100b provided in the third embodiment of the present application is similar to the structure of the second embodiment, but the difference is: the connecting portion 223a in the first embodiment of the third embodiment The structure and arrangement of the multi-electrode assembly 50. Specifically, the ablation occlusion device 100b also includes a sealing portion 221a, a connecting portion 223a, and an anchoring portion 225. The sealing part 221a and the connecting part 223a are of integral structure. The connecting part 223a and the anchoring part 225 are connected by a connecting piece 60; the sealing part 221a includes a disc mesh frame 2212, which is used for pressing Fitted at the entrance of the left atrial appendage, the connecting part 223a includes a grid frame 2232 that can be inserted into the entrance of the left atrial appendage, that is, the integral structure of the sealing part 221a and the connecting part 223a connects the entrance of the left atrial appendage with the left atrial appendage. The neck of the auricle is sealed at the same time. The proximal end of the grid frame 2232 is open and connected to the grid frame 2212, and the distal end of the grid frame 2232 is folded and connected to the proximal end of the anchoring portion 225 through the connecting member 60. The shape of the mesh frame 2212 is consistent with the shape of the entrance of the left atrial appendage, and the shape of the mesh frame 2232 is consistent with the shape of the neck of the left atrial appendage. The diameter of the grid frame 2212 is slightly larger than the inner diameter of the entrance of the left atrial appendage, and the grid frame 2212 adopts a disc-shaped structure with a short axial length, and the disc-shaped structure can directly press against the entrance of the left atrial appendage and face the left atrium s surface.

Specifically, the ablation occlusion device 100b has a double-disc structure, including a proximal disc and a distal disc. The proximal disc and the distal disc are connected by a connecting piece 60. The proximal disc includes a sealing portion 221a and a connecting portion 223a; the distal disc is an anchoring portion 225; both the proximal disc and the distal disc are made of nickel-titanium wire braiding and heat setting.

The integral structure of the sealing portion 221a and the connecting portion 223a is in the shape of a bottle plug, that is, the diameter of the sealing portion 221a is larger than the diameter of the connecting portion 223a, and the diameter of the connecting portion 223a gradually decreases from the proximal end to the distal end, forming a frustum shape. The connecting portion 223a is located at the distal end of the proximal disc. The outer wall surface of the connecting portion 223a is provided with at least two multi-electrode assemblies 50. Specifically, the outer wall surface of the grid frame 2232 of the connecting portion 223a is provided with at least two multi-electrode assemblies 50. Each multi-electrode assembly 50 includes a carrier member 53 fixed on the outer surface of the connecting portion 223a and a plurality of electrode units 52 arranged outside the carrier member 53. Each carrier member 53 includes at least one circle surrounding the outer surface of the connecting portion 223a in the circumferential direction of the support frame 22, and the upper electrode unit 52 of each multi-electrode assembly 50 is along the length of the surrounding section. The direction is evenly arranged.

The anchor body 2252 of the anchor portion 225 has a cylindrical structure. Both ends of the distal and proximal ends of the cylindrical structure are closed to form a cylindrical structure. The grid structure 2212 of the connecting portion 223a and the grid frame 2232 of the anchoring portion 225 are connected together by the connecting member 60, and can be connected together by welding or pressing. The connecting piece 60 adopts a columnar structure made of a metal material, and the connecting piece 60 is arranged between the center of the end surface of the distal end of the connecting portion 223a and the center of the end surface of the proximal end of the anchoring portion 225.

In this embodiment, the energy processing system at least includes an energy generator, an electrocardiogram synchronizer, and a multi-channel physiological recorder. The energy generator is a pulse generator, and the cell membrane on the inner wall of the left atrial appendage is irreversibly electrically broken through the high-intensity pulsed electric field, so that the cell apoptosis is realized so as to realize the non-thermal effect ablation of the cells, thereby realizing the ablation operation. The ablation seal of the present application The blocking device 100b can also collect intracardiac electrical signals at the electrode unit 52 that applies pulse energy. Before ablation, the intracardiac electrical signals are collected and transmitted to the electrocardiogram synchronizer, so that the pulse output is synchronized during the absolute refractory period of myocardial contraction. Interfere the heart rate and reduce sudden arrhythmia; after the ablation is completed, the intracardiac signal can also be used to determine whether the tissue is completely electrically isolated. The multiple power connection modes of the electrode unit 52 array are the same as those in the first embodiment, and will not be repeated here.

Please refer to FIG. 8, which is a schematic structural diagram of a second embodiment of the ablation and occlusion device 100c of the third embodiment. The structure of the second embodiment of the ablation and occlusion device provided by the third embodiment of the present application is similar to the structure of the first embodiment of the third embodiment, except that the multi-electrode assembly 50 is disposed on the anchoring portion 225 At the proximal end of the outer wall surface, the multi-electrode assembly 50 surrounds at least one circle along the outer wall surface of the anchor body 2252. In this embodiment, the multi-electrode assembly 50 surrounds the outer wall surface of the anchor body 2252 three times.

It should be noted that, without departing from the principle of the embodiments of the present application, the specific technical solutions in the above embodiments may be mutually applicable, and will not be repeated here.

The above is the implementation of the embodiments of the present application. It should be pointed out that for those of ordinary skill in the art, without departing from the principle of the embodiments of the present application, several improvements and modifications can be made, and these improvements and modifications are also Treated as the scope of protection of this application.

Claims

An ablation occlusion device, comprising an occlusion element and an energy processing system, characterized in that the ablation occlusion device further includes a multi-electrode assembly arranged on the occlusion element, the multi-electrode assembly and the energy Processing system connection;

The multi-electrode assembly includes a plurality of electrode units, at least some of the electrode units are used to ablate the target tissue, and at least some of the electrode units are used to monitor electrophysiological signals of the target tissue.
The ablation occlusion device according to claim 1, wherein the multi-electrode assembly further comprises a carrier member, the carrier member is made of a flexible insulating material, and the carrier member includes an outer edge along the occlusion member. The surface surrounds at least one circle of surrounding sections, and each circle of the surrounding section includes at least one electrode unit.
The ablation occlusion device according to claim 2, wherein each electrode unit is connected to a conductive wire, and the conductive wires are insulated from each other and are accommodated in the carrier member along the extending direction of the carrier member. Extension, electrically connected to an energy processing system, the energy processing system at least includes the functions of energy emission, collection of ECG signals, and signal processing.
The ablation occlusion device according to claim 3, wherein the energy processing system at least comprises an energy generator, and the energy of the energy generator is any one of pulse, radio frequency, and microwave.
The ablation occlusion device according to claim 4, wherein the energy generator comprises an impedance detection module, and the impedance detection module is used to detect the adherence of the electrode unit to the tissue.
The ablation and occlusion device according to claim 3, wherein the energy processing system comprises a multi-channel physiological recorder and/or a three-dimensional mapping system and/or an electrocardiogram synchronizer.
The ablation occlusion device according to claim 3, wherein the electrode unit is an electrode sheet arranged on the outer wall of the carrier member, and the shape of the electrode sheet is flat, curled or folded, and the conductive The wire passes through the outer wall of the carrier member and is electrically connected to the energy processing system.
The ablation occlusion device according to claim 3, wherein the electrode unit comprises an electrode sheet and an insulating substrate arranged on the back of the electrode sheet, and the conductive wire passes through the outer wall of the carrier member and the The substrate is electrically connected to the energy processing system.
The ablation occlusion device according to claim 8, wherein the substrate of the electrode unit is provided with an elastic member and a pull wire, one end of the elastic member is connected to the substrate, and the other end of the elastic member is fixed to the carrier member One end of the pull wire is connected to the substrate, and the pull wire is accommodated in the carrier member, and the other end extends to the operating handle, and different forces are applied to the pull wire through the operating handle to adjust the electrode sheet relative to The distance of the inner wall of the left atrial appendage.
The ablation and occlusion device according to claim 9, wherein the elastic member is a spring, and when the ablation and occlusion device is in the initial state, the pulling wire is in a tight state and the spring is compressed, and the electrode sheet is attached to the The outer wall of the carrier member; when the energy processing system is working, the pull wire is in a relaxed state and elastically resets, and the electrode sheet leaves the outer wall of the carrier member and fits the inner wall of the left atrial appendage.
The ablation occlusion device according to any one of claims 2 to 10, wherein the carrier member is arranged outside the occlusion member by binding, sticking or suture, and after the multi-electrode assembly is completed, The external force pulls the carrier member to separate the multi-electrode assembly from the blocking member and withdraw from the body.
The ablation blocking device according to claim 1, wherein the blocking member is an insulating frame made of elastic metal or polymer material, and the proximal and/or distal ends of the insulating frame are provided with at least There is a barrier film.