CN116407253A

CN116407253A - Ablation occlusion system

Info

Publication number: CN116407253A
Application number: CN202111665434.XA
Authority: CN
Inventors: 王永胜; 程晓阳; 王坤; 尤岩; 李建民
Original assignee: Hangzhou Dinova EP Technology Co Ltd
Current assignee: Hangzhou Dinova EP Technology Co Ltd
Priority date: 2021-12-31
Filing date: 2021-12-31
Publication date: 2023-07-11
Also published as: WO2023125866A1

Abstract

The application discloses ablation plugging system, including conveyor, ablation plugging device and electrode. The ablation electrode is connected to the distal end of the delivery device. The ablation blocking device comprises a supporting framework and a covering film. The support skeleton is made of conductive material. The coating film is coated outside the supporting framework. The electrode is arranged on the conveying device and/or the ablation plugging device and is positioned on one side of the covering film, which is away from the supporting framework, and the electrode is arranged in an insulating way with the supporting framework through the covering film and is used for ablating tissues to be ablated. Adopt the ablation shutoff system of this application, based on set up the tectorial membrane between braced skeleton and electrode to make the electrode pass through tectorial membrane and the insulating setting of braced skeleton, consequently treat the in-process that melts the tissue at the adoption electrode, braced skeleton's electric energy can not transmit to the electrode, thereby can avoid braced skeleton and the direct electric conduction of electrode and take place the phenomenon of short circuit, and then ensure the security, stability and the ablation effect that ablate shutoff device melts.

Description

Ablation occlusion system

Technical Field

The application relates to the technical field of medical instruments, in particular to an ablation plugging system.

Background

Atrial fibrillation (abbreviated as atrial fibrillation) is the most common sustained arrhythmia, with increasing incidence of atrial fibrillation with age, up to 10% of people over 75 years old. The prevalence of atrial fibrillation is also closely related to coronary heart disease, hypertension, heart failure, and the like. The left atrial appendage is not only the most important part of atrial fibrillation thrombosis, but also one of the key areas for the occurrence and maintenance of atrial fibrillation, and part of atrial fibrillation patients can be electrically isolated by the active left atrial appendage).

One-stop therapy of radiofrequency ablation and left atrial appendage occlusion is one of the treatment hotspots of current atrial fibrillation. Currently, a single-station treatment method combining catheter radio frequency ablation and left atrial appendage occlusion has achieved many cases of successful treatment of atrial fibrillation. In the one-stop treatment method, through left auricle occlusion, a patient can still obtain a good stroke prevention effect under the condition of not taking anticoagulant medicines for life; and then the catheter radio frequency ablation is combined to recover and maintain Dou Lv so as to improve symptoms of patients suffering from atrial fibrillation, so that the patients can obtain a stable long-term treatment effect. But the ablation mode adopted at present is mainly as follows: electrical isolation of the left atrial appendage is not increased by pulmonary vein electrical isolation (PVI) plus ablation of "atrial fibrillation" outside of the pulmonary vein (unless triggering of the foci from the left atrial appendage can result in sustained atrial fibrillation, atrial flutter, or atrial speed). By adopting the ablation method, the recurrence rate of atrial fibrillation of a patient after 1 year is high.

Studies have shown that for long-range continuous atrial fibrillation patients, left atrial appendage electrical isolation can reduce postoperative atrial fibrillation recurrence without increasing surgical complications.

However, the current active catheters for treating atrial fibrillation are designed for pulmonary vein ablation, and the existing pulmonary vein active catheters are obviously not suitable for left atrial appendage ablation due to the large difference of the size and depth of the left atrial appendage opening and the position of the left atrial appendage of different patients. In addition, if ablation and plugging are to be performed on the left auricle in the one-stop treatment process, the active catheter and the left auricle ablation plugging device are required to be introduced in an interventional manner, and the key is that two devices are sequentially positioned at the position of the left auricle mouth and are respectively subjected to ablation and plugging, and the active catheter and the left auricle plugging have large positioning difficulty at the left auricle mouth, so that the surgical procedures are complex, the time consumption is long, and the convenience of one-stop treatment operation of ablation and left auricle plugging is not improved. In addition, the supporting framework of the existing ablation plugging device is directly electrically connected with the electrode, so that electric sparks are easily generated to cause damage to tissues.

Disclosure of Invention

In view of this, the present application provides an ablation blocking system to solve the problem that the supporting framework of the existing ablation blocking device is directly electrically connected to the electrode, so that electric spark is easily generated to cause damage to the tissue.

The embodiment of the application provides an ablation plugging device, including:

a conveying device;

an ablation occlusion device connected to the distal end of the delivery device; the ablation occlusion device comprises:

a support skeleton made of a conductive material; and

the coating film is coated outside the supporting framework; and

the electrode is arranged on the conveying device and/or the ablation plugging device, is positioned on one side of the covering film, which is away from the supporting framework, and is arranged in an insulating way through the covering film and the supporting framework, and is used for ablating tissues to be ablated.

The embodiment of the application provides an ablation plugging system, which comprises a conveying device, an ablation plugging device and an electrode. The ablation blocking device comprises a supporting framework and a covering film. Based on set up the tectorial membrane between braced skeleton and electrode to make the electrode pass through tectorial membrane and the insulating setting of braced skeleton, consequently adopt the electrode to treat the in-process that melts the tissue, the electric energy of electrode can not transmit to braced skeleton, can avoid electrode and braced skeleton electric coupling promptly, lead to braced skeleton electric conduction, and take place to ablate the area and enlarge, the problem emergence that ablation degree of depth is shallower, and then ensure security, stability and the ablation effect of the electrode ablation of ablation shutoff system. In addition, the tectorial membrane can also prevent thrombus in the left auricle from flowing out, so that the problems of cerebral embolism (cerebral apoplexy), limb arterial embolism and the like caused by blood flowing to various parts of the whole body after thrombus in the left auricle is removed are avoided.

Drawings

In order to more clearly illustrate the embodiments of the present application or the technical solutions in the prior art, the drawings that are required in the embodiments or the description of the prior art will be briefly described below, it being obvious that the drawings in the following description are only some embodiments of the present application, and that other drawings may be obtained according to these drawings without inventive faculty for a person skilled in the art.

Fig. 1 is a schematic structural diagram of an ablation occlusion system provided in an embodiment of the present application.

Fig. 2 is a schematic structural view of a first embodiment of an ablation occlusion device of the ablation occlusion system of fig. 1.

Fig. 3 is a schematic structural view of a second embodiment of an ablation occlusion device of the ablation occlusion system of fig. 1.

Fig. 4A is a scanning electron microscope image of the covering film of the ablation occlusion device of fig. 2 and 3.

Fig. 4B is a scanning electron microscope image of a conventional film.

Fig. 5 is a schematic view of the support skeleton and electrode structure of the ablation occlusion device of fig. 2.

Fig. 6 is a schematic view of the structure of the support skeleton of the ablation occlusion device of fig. 5 with an insulating coating.

Fig. 7 is a schematic structural view of a third embodiment of an ablation occlusion device of the ablation occlusion system of fig. 1.

Fig. 8 is a schematic structural view of a fourth embodiment of an ablation occlusion device of the ablation occlusion system of fig. 1.

Fig. 9 is a top view of an ablation occlusion device of the ablation occlusion system of fig. 2.

Fig. 10 is a schematic structural view of a fifth embodiment of an ablation occlusion device of the ablation occlusion system of fig. 1.

Fig. 11 is a schematic structural view of a sixth embodiment of an ablation occlusion device of the ablation occlusion system of fig. 1.

Fig. 12 is a schematic view of the support frame and electrodes of the ablation occlusion device of the ablation occlusion system of fig. 11.

Fig. 13 is a schematic structural view of a second embodiment of the ablation occlusion system of fig. 1.

Fig. 14 is a schematic structural view of a portion of the structure of the ablation occlusion system of fig. 13.

Fig. 15 is a partial schematic structural view of a third embodiment of the ablation occlusion system of fig. 1.

Description of the main reference signs

Ablation occlusion system

1000, 1000a, 1000b

Ablation occlusion device

100, 100a, 100c, 100e, 100g, 100h

Support skeleton 101

First strut 1010a

Second strut 1010b

Distal section 1011

Proximal section 1012

Insulating section 1013

Anchoring portion 10

First skeleton 11

First through hole 110

First connecting portion 111

Receiving groove 112

Anchor 13

Plug portion 20

Proximal disc face 23

Distal disk surface 24

Waist 25

Insulation section 27

Ablation section 28

Second skeleton 21

Second through hole 210

Second connecting portion 211

Film 102

Insulating film 106

Micropores 33

Stitch point 103

Load-bearing section 104

Insulating coating 105

Insulating connector 40

Third through hole 401

Channel 1001

Electrode 300

Connection point 301

Connecting rod 302

Ablation member 50

First ablating member 51

Second ablating member 52

Conveying device 200

Sheath 201

Inner tube 2011

Outer tube 2012

Control handle 202

Movable conduit 60

Catheter body 61

Adjustable curved section 611

Body segment 612

Transition section 613

Electrode 300a

Positive electrode 301a

Negative electrode 302a

The following detailed description will further illustrate the application in conjunction with the above-described figures.

Detailed Description

The following description of the technical solutions in the embodiments of the present application will be made clearly and completely with reference to the drawings in the embodiments of the present application, and it is apparent that the described embodiments are only some embodiments of the present application, not all embodiments. All other embodiments, which can be made by one of ordinary skill in the art without undue burden from the present disclosure, are within the scope of the present disclosure.

In the field of interventional medicine, the end of the medical device near the operator is generally referred to as a proximal end (i.e., an operation end), and the end of the medical device remote from the operator is generally referred to as a distal end (i.e., an insertion end). In particular, the distal end refers to the end of the medical device that is free to be inserted into the body of an animal or human. Proximal refers to the end that is intended for user or machine operation or for connection to other devices. In other words, after the left atrial appendage occlusion ablation device is implanted in the left atrial appendage, the proximal end of a component in the left atrial appendage occlusion ablation device is the end of the component near the left atrium, and the distal end of the component is the end of the component near the left atrial appendage. The left atrial appendage is the location where it enters the left atrial appendage from the left atrium.

The ablation plugging device provided by the embodiment of the application is used for being implanted into the left auricle opening, and can perform pulse ablation, radio frequency ablation or microwave ablation on left auricle tissues. Wherein, the pulse ablation utilizes a high-intensity pulse electric field to enable cell membranes to generate irreversible electric breakdown, which is called irreversible electroporation (Irreversible electroporation, IRE) in the medical field, so that cells are apoptotic to realize non-thermal effect ablation of cells, and the influence of a thermal sinking effect is avoided. The high-voltage pulse sequence generates less heat, does not need normal saline to be washed for cooling, and can effectively reduce the occurrence of air explosion, eschar and thrombus. The pulse ablation treatment time is short, the treatment time of applying a group of pulse sequences is less than 1 minute, and the whole-course ablation time is generally not more than 5 minutes. And because the reaction threshold values of different tissues to the pulse electric field are different, the possibility is provided for ablating cardiac muscle without disturbing other adjacent tissues, thereby avoiding the accidental injury of the adjacent tissues of the left auricle. In addition, compared with other energies, pulse ablation does not need heat conduction to ablate deep tissues, and all myocardial cells distributed above a certain electric field strength are subjected to electroporation, so that the requirement on the catheter attaching pressure during ablation is reduced. Therefore, even if the ablation instrument is not completely attached to the inner wall of the left atrial appendage after entering the left atrial appendage, the IRE ablation effect is not affected. The electrodes for applying pulse energy can also collect the electrocardiosignals, and the electrocardiosignals are collected and transmitted to an electrocardiosignal synchronizer before ablation, so that pulse output is synchronized in the absolute refractory period of myocardial contraction, thereby not interfering with heart rate and reducing sudden arrhythmia; after the ablation procedure, it can also be determined from the intracardiac signals whether the tissue is completely electrically isolated.

It is to be understood that the terminology used in the description and claims of the present application and in the preceding figures is for the purpose of describing particular embodiments only, and is not intended to be limiting of the present application. The terms first, second and the like in the description and in the claims of the present application and in the above-described figures, are used for distinguishing between different objects and not for describing a particular sequential order. The singular forms "a," "an," and "the" are intended to include the plural forms as well, unless the context clearly indicates otherwise. The term "comprising" and any variations thereof is intended to cover a non-exclusive inclusion. Furthermore, the present application may be embodied in many different forms and is not limited to the embodiments described in the present embodiment. The following specific examples are provided to facilitate a more thorough understanding of the present disclosure, in which words of upper, lower, left, right, inner, outer, etc., designate orientations only with respect to the locations of the illustrated structures in the corresponding drawings.

The description is then made of the preferred embodiments for carrying out the present application, although the above description is made for the purpose of illustrating the general principles of the present application and is not meant to limit the scope of the present application. The scope of the present application is defined by the appended claims.

The ablation occlusion system 1000 is a device that is percutaneously introduced into the body and occludes defects in the occluding tissue and ablates the tissue to be ablated for the purpose of treating diseases (e.g., atrial fibrillation, etc.). Such occlusion tissues include, but are not limited to, the left atrial appendage, the foramen ovale, arterial ducts, atrial septum, ventricular septum, and the like. It should be noted that, in this application, the left atrial appendage is taken as an example of the occlusion tissue, and the advantage of the ablation occlusion system 1000 for treating the left atrial appendage is described. It will be appreciated that the occluding tissue may also be other tissue as mentioned above.

Referring to fig. 1, fig. 1 is a schematic structural diagram of an ablation blocking system 1000 according to an embodiment of the present application. The ablation occlusion system 1000 includes an ablation occlusion device 100 and a delivery device 200 and an electrode 300. The ablation occlusion device 100 is connected to the distal end of the delivery device 200. The delivery device 200 is used to deliver the ablation occlusion device 100 to an occlusion tissue site, such as the left atrial appendage. The ablation occlusion device 100 includes a support matrix 101 and a cover film 102. The supporting skeleton 101 is made of a conductive material. The coating film 102 is coated outside the supporting framework 101. In some embodiments, the electrode 300 may be disposed on the ablation occlusion device 100. In other embodiments, the electrode 300 may also be disposed on the delivery device 200. The electrode 300 is located on the side of the cover 102 facing away from the support skeleton 101. The electrode 300 is provided to be insulated from the support frame 101 by the coating film 102. The electrode 300 is used for ablating tissue to be ablated. In this way, during the process of using the ablation blocking device 100, the electric energy of the electrode 300 is not transmitted to the supporting framework 101, that is, the problem that the supporting framework 101 is conductive, the ablation area is enlarged and the ablation depth is shallower due to the electric coupling between the electrode 300 and the supporting framework 101 is avoided; thereby avoiding the phenomenon of short circuit between the electrode 300 and the supporting framework 101 and further ensuring the safety, stability and ablation effect of the ablation blocking device 100. In addition, the covering film 102 can also prevent thrombus in the left auricle from flowing out, so that the problems of cerebral embolism (cerebral apoplexy), arterial embolism of limbs and the like caused by blood flowing to all parts of the whole body after thrombus in the left auricle is removed are avoided.

In this embodiment, the delivery device 200 includes a sheath 201 for receiving the ablation occlusion device 100 and a control handle 202 secured to the proximal end of the sheath 201. The control handle 202 is used to control the ablation occlusion device 100 to extend from the distal end of the sheath 201 and release to the occlusion tissue (left atrial appendage); alternatively, for controlling the retrieval of the ablation occlusion device 100 into the sheath 201. The control handle 202 is also used to control the advancement, retraction, and rotation of the sheath 201 in the vessel, as well as the ablation process of the electrode 300.

It should be understood by those skilled in the art that the described figure 1 is merely an example of an ablation occlusion system 1000 and is not intended to limit the ablation occlusion system 1000, and that the ablation occlusion system 1000 may include more or fewer components than shown in figure 1, or may combine certain components, or different components, e.g., the ablation occlusion system 1000 may also include temperature sensors, visualization locators, etc. The temperature sensor is used to detect the temperature of the target tissue during ablation to prevent the temperature from being too low or too high.

In this embodiment, electrode 300 may be used as an ablation electrode to effect ablation of a region of tissue to be ablated. When the electrode 300 is used to perform an ablation function, the electrode 300 is externally connected to an energy generating device. Wherein the energy generating device is used for providing ablation energy to the electrode 300 of the ablation occlusion device 100 during the ablation process, such that the electrode 300 delivers the ablation energy to the tissue region to be ablated for ablation. The energy generating device can output corresponding ablation energy according to the ablation parameters required by the tissue to be ablated of the tissue area to be ablated. Ablation energy includes, but is not limited to, at least one of radio frequency energy, microwave energy, pulsed energy, and the like. The energy generating device is, for example, but not limited to, one of a radio frequency generator, a microwave physiotherapy instrument, a pulse generator, or any combination thereof.

In some embodiments, electrode 300 may also function as a mapping electrode to perform a mapping function. When the electrode 300 is used to perform a mapping function, the electrode 300 is connected to an external mapping device (not shown) and the acquired electrophysiological signals of the tissue region to be ablated are transferred to the external mapping device. Specifically, the electrode 300 is electrically connected with the external marking device, and senses the physiological activity of the tissue to be ablated of the ablation site, so as to judge whether the tissue to be ablated needs to be located at the ablation site, so that the tissue to be ablated is ablated more pertinently, the ablation effect is improved, the treatment effect of the operation is improved, and a more exact basis is provided for accurate positioning of the operation.

In some embodiments, the number of electrodes 300 may include a plurality of electrodes 300 spaced apart, with portions of the electrodes 300 being used to electrically connect to an energy generating device to perform an ablation function and portions of the electrodes 300 being used to electrically connect to an external mapping device to perform a mapping function. In other embodiments, the number of electrodes 300 may also include one.

In some embodiments, each electrode 300 is optionally used to perform an ablation function or a mapping function.

In some embodiments, electrode 300 is used only to perform an ablation function or a mapping function.

The ablation occlusion device 100 is a self-expanding stent. For example, the ablation occlusion device 100 may be a flexible metallic stent. In this embodiment, the ablation occlusion device 100 is a nitinol stent. When the ablation occlusion device 100 is delivered by the delivery device 200, the radial dimension of the ablation occlusion device 100 is contracted to a smaller state for delivery in the sheath 201; when the ablation occlusion device 100 is delivered to the left atrial appendage portion for release, the ablation occlusion device 100 may automatically expand to a predetermined shape and size to rest on the inner wall of the left atrial appendage portion, and the ablation occlusion device 100 may exert a radial supporting effect on the inner wall of the left atrial appendage portion to be secured thereto.

It should be noted that, in fig. 1 to 15, the ablation occlusion device 100 and the electrode 300 of the ablation occlusion device 100 are in a free expanded state, i.e., a state in which the ablation occlusion device 100 is not implanted into the left atrial appendage portion after being released from the distal end of the sheath 201. After the ablation occlusion device 100 is implanted into the left atrial appendage, the ablation occlusion device 100 is susceptible to deformation due to the conformation of the left atrial appendage to a different shape.

The cover film 102 is fixed to the support frame 101. In some embodiments, the coating 102 may be formed by dipping, solution casting, spraying, casting, compression molding, or injection molding, such that the porosity of the coating 102 is relatively small, thereby enhancing the insulating properties of the coating 102. The formed coating film 102 is fixed on the supporting framework 101 by a sewing mode, a hot pressing mode or an adhesion mode, so that the coating film 102 can be attached to the outer surface of the supporting framework 101, and gaps are reduced at the connecting positions between the supporting framework 101 and the coating film 102.

Referring to fig. 1 and 2 together, fig. 2 is a schematic structural view of a first embodiment of an ablation occlusion device 100 of the ablation occlusion system 1000 of fig. 1. In the present embodiment, the molded cover film 102 is fixed to the support frame 101 by stitching. Specifically, a plurality of seam points 103 are formed at intervals at the connection point of the edge of the cover film 102 and the support skeleton 101. The cover film 102 is connected with the support skeleton 101 by sewing at each sewing point 103. The suture is sewn at least one turn in the circumferential direction of the support frame 101. The suture may be selected from non-absorbable biocompatible sutures such as, but not limited to, wire, cotton, polyester, polypropylene, and the like. The suture may also be an absorbable biocompatible suture, such as, but not limited to, a catgut, a polyglycolide, a multifilament non-biodegradable suture, etc., so that the suture gradually degrades after a certain period of use, thereby facilitating a reduction in the irritation to the human body and further reducing the long-term complications rate of the long-term indwelling ablation occlusion device 100. The suture thread can also be wound fiber thread, etc. In this embodiment, the suture material includes, but is not limited to, at least one of polypropylene, polyethylene terephthalate, polytetrafluoroethylene. Preferably, the suture material is polypropylene with better tensile strength and hardness. The suture adopts a double strand suture, so that the covering film 102 and the supporting framework 101 have better connection strength. In other embodiments, more strands of suture, or a single strand of suture, may also be used.

Referring to fig. 1 and 3 together, fig. 3 is a schematic structural view of a second embodiment of an ablation occlusion device 100a of the ablation occlusion system 1000 of fig. 1. In other embodiments, as shown in fig. 3, the cover film 102 may be formed directly on the support skeleton 101 by dipping or spraying. The coating film 102 is directly formed on the supporting framework 101 in an impregnation mode or a spraying mode, so that the porosity of the coating film 102 is relatively small, the insulating performance of the coating film 102 is further enhanced, in addition, the coating film 102 can be tightly formed on the outer surface of the supporting framework 101, seamless connection between the coating film 102 and the supporting framework 101 is realized, and good insulativity between the electrode 300 and the supporting framework 101 is ensured.

Referring to fig. 2, fig. 3, and fig. 4A to fig. 4B together, fig. 4A is a scanning electron microscope image of the coating film 102 of the ablation plugging device 100a in fig. 2 and fig. 3, that is, fig. 4A is a scanning electron microscope image of the coating film 102 in the embodiment of the present application, that is, directly formed on the supporting framework 101 by a dipping or spraying method; or a scanning electron microscope image of the coating film 102 obtained by dipping, solution casting, spraying, casting, compression molding or injection molding; fig. 4B is a scanning electron microscope image of a conventional coating film 102 manufactured by an electrospinning process. As shown in fig. 4A, the surface of the coating 102 is defect-free under a magnification of 1 ten thousand times, i.e., the surface of the coating 102 is flat. The scanning electron microscope of fig. 4A does not see that the coating film 102 has obvious pores, which indicates that the porosity and pore diameter of the coating film 102 prepared by the dipping process are smaller, and the coating film 102 passes through to ensure that the coating film 102 has better insulation, so that the problem of electrical conduction between the electrode 300 and the supporting framework 101 in the electrified state of the electrode 300 is avoided. As shown in fig. 4B, under the condition of 1 ten thousand times magnification, obvious holes can be seen on the surface of the existing coating, which indicates that the porosity and the pore diameter of the coating prepared by the electrostatic spinning process are larger, so that the insulation performance between the electrode and the supporting framework is poor, the electrode is easy to be electrically coupled with the supporting framework at the position with larger pores, the supporting framework is conductive to generate sparks, the tissue is easy to eschar, and even heart perforation can cause pericardial effusion. It should be noted that, the coating film 102 prepared in the embodiment of the present application for scanning by an electron microscope is the same as the coating film prepared by the existing electrostatic spinning process.

It will be appreciated that the insulating properties of the coating 102 are affected by the porosity and thickness of the coating 102, the thicker the coating 102, the better the insulating properties, but the too thick coating 102 will affect the mechanical properties of the ablation occlusion device 100, and the degradation capability of the degradable coating 102 or increase the probability of some inflammation, chronic diseases in the body caused by the non-degradable coating 102, in order to compromise the insulating properties and degradation capability or biocompatibility of the coating 102, the porosity of the coating 102 is less than 2.5%, and the thickness of the coating 102 is 0.05mm-0.3mm.

The material of the covering film 102 comprises an insulating material, so that the electrode 300 is prevented from being electrically coupled with the supporting framework 101 in an ablation state, and the problem of electric conduction of the supporting framework 101 occurs. In some embodiments, the cover film 102 is made of an insulating material, thereby enhancing the insulating properties of the cover film 102 as a whole. In other embodiments, the inner and/or outer sides of the cover film 102 are each provided with an insulating coating.

Optionally, in some embodiments, the material of the covering film 102 comprises an insulating degradable material, i.e. the covering film 102 is made of an insulating degradable material, thereby facilitating an improved biocompatibility of the ablation occlusion device 100a while ensuring insulating properties between the covering film 102 and the support matrix 101 and the electrode 300. In this way, the covering film 102 will gradually degrade after a certain period of use and eventually become water and carbon dioxide that are easily absorbed and metabolized by the human body, thereby facilitating the reduction of the irritation to the human body and further reducing the long-term complications rate of the long-term indwelling ablation occlusion device 100 a. The insulating degradable material includes, but is not limited to, a copolymer or blend of one or more polymers of polylactic acid (PLA), polycaprolactone (PCL).

In other embodiments, the material of the covering film 102 may further include an insulating non-degradable material, where the non-degradable material is stable in chemical properties, and accordingly stable in structure, not easy to break, and stable in long-term mechanical properties, particularly mechanical properties. Insulating non-degradable materials include, but are not limited to, one or any combination of polyimide, polysulfone (PSF), polyolsulfone resin (PES), polyvinylpyrrolidone (Polyvinyl pyrrolidone, PVP), polymethyl methacrylate (Polymethyl methacrylate, PMMA), hydrogenated styrene-butadiene block copolymer (Styrene ethylene butylene styrene, SEBS), thermoplastic Polyurethane elastomer (Thermoplastic polyurethanes, TPU), polyurethane (Polyurethane, PU), parylene, silicone rubber, and other polymeric materials.

Referring to fig. 2 and 5 together, fig. 5 is a schematic structural diagram of the support frame 101 and the electrode 300 of the ablation blocking device 100a in fig. 2, i.e. in fig. 5, the covering film 102 of the ablation blocking device 100 in fig. 2 is omitted so as to illustrate the structures of the support frame 101 and the electrode 300 and the relationship therebetween. It should be noted that, the structure and the relative positional relationship of the support frame 101 and the electrode 300 shown in fig. 3 may be described with reference to fig. 5.

The supporting skeleton 101 is constructed in a net structure. The support skeleton 101 may be woven from woven filaments having a shape memory effect to form a mesh structure; alternatively, the supporting skeleton 101 may also be formed into a mesh structure by cutting at least one of a rod-like structure, a tubular structure, and a plate-like structure having a shape memory effect. The material of the support frame 101 includes a metal material having biocompatibility, thereby enhancing the overall strength of the support frame 101. The material of the support matrix 101 includes a non-degradable metallic material. The non-degradable metallic material includes, but is not limited to, at least one of stainless steel, tungsten alloy, cobalt-based alloy, and nickel-titanium alloy. In other embodiments, the material of the support matrix 101 comprises a degradable metallic material. The degradable metallic material includes, but is not limited to, at least one of magnesium alloy, iron alloy or zinc alloy. In some embodiments, the material of the support matrix 101 may also or further comprise at least one of a high molecular polymer material, a non-degradable non-metallic material, a degradable non-metallic material, or any combination therebetween.

In this embodiment, the ablation occlusion device 100 is a left atrial appendage ablation occlusion device. The support frame 101 is constructed as a double-layered net tray. The double layer net tray comprises a plurality of net holes. The size and shape of the plurality of mesh holes can be set according to actual needs, and the application is not particularly limited. The support frame 101 includes an anchor portion 10 and a blocking portion 20 disposed at a proximal end of the anchor portion 10. The anchoring part 10 is used for being released inside the left auricle and mutually anchored with the tissue of the inner wall of the left auricle, and the blocking part 20 is used for blocking the mouth part of the left auricle so as to avoid thrombus in the left auricle from flowing out. Both the blocking portion 20 and the anchoring portion 10 may be provided with at least one flow blocking film for blocking the outflow of thrombus inside the left atrial appendage, and in some embodiments, the flow blocking film is used for blocking the blood flow formed at the mouth of the left atrial appendage, so as to avoid cerebral apoplexy caused by the outflow of thrombus inside the left atrial appendage. As shown in fig. 5, the anchor portion 10 and the blocking portion 20 together form a multi-disc structure. In this embodiment, the anchoring portion 10 and the blocking portion 20 together form a double-disc structure. The anchor portion 10 forms an anchor disc at the distal end of the support frame 101 and the occluding portion 20 forms a sealing disc at the proximal end of the support frame 101. In some embodiments, the anchoring portion 10 and the blocking portion 20 together form a single-disc structure.

Referring to fig. 2, fig. 5 and fig. 6 together, fig. 6 is a schematic structural view of the support frame 101 of the ablation blocking device 100 in fig. 5 with an insulating coating 105. Optionally, the support skeleton 101 comprises a load-bearing section 104. In the present embodiment, the bearing section 104 is a section in the axial direction of the anchor portion 10. The electrode 300 is arranged on the outer side surface of the covering film 102 facing away from the supporting framework 101; the electrode 300 is arranged corresponding to the bearing section 104, and the insulating coating 105 or the insulating sleeve is arranged on the surface of the supporting framework 101 corresponding to the bearing section 104, so that the coating 102 and the insulating coating 105 or the insulating sleeve play an insulating role together, the voltage withstand value of the supporting framework 101 is improved, and the reliability of insulation between the supporting framework 101 and the electrode 300 is improved. Thus, on the one hand, when the covering film 102 is broken, the insulating coating 105 or the insulating sleeve on the supporting framework 101 can still play a role of insulating between the supporting framework 101 and the electrode 300; on the other hand, when the insulating coating 105 or the insulating sleeve on the supporting framework 101 is damaged, the coating 102 can still play a role in insulating between the supporting framework 101 and the electrode 300, so that the reliability and stability of the insulation between the supporting framework 101 and the electrode 300 are greatly improved.

The anchoring portion 10 and the blocking portion 20 each include a plurality of support rods 1010, and the plurality of support rods 1010 together form the support frame 101. In some embodiments, the load bearing section 104 may be the entire area of the anchor 10, thereby facilitating the machining process. Specifically, the anchoring portion 10 may be manufactured by a cutting process, and the surfaces of the plurality of support bars 1010 cut in the anchoring portion 10 are each provided with an insulating coating and/or sleeved with an insulating sleeve. In other embodiments, the anchoring portion 10 is woven from braided wires, for example, each support bar 1010 in the anchoring portion 10 is formed by combining at least one braided wire into one strand, for example, each support bar 1010 includes one braided wire, or each support bar 1010 includes a plurality of braided wires, the plurality of braided wires are combined into one strand, for example, are hinged into one strand, and an insulating sleeve is sleeved on the surface of the support bar 1010, and/or an insulating coating is provided; alternatively, the surface of each braided wire in each support rod 1010 of the anchor 10 is provided with an insulating coating and/or is sleeved with an insulating sleeve. In other embodiments, the load-bearing section 104 may be a partial region of the anchor 10 to save costs.

In some embodiments, the carrier section 104 may also be disposed at the occlusion 20, such as at a proximal end of the occlusion 20; or, provided at the distal end portion of the blocking portion 20; or, provided in the middle of the blocking portion 20; alternatively, the insulating properties between the electrode 300 provided on the anchor portion 10 and the second frame 21 constituting the occluding portion 20 are improved by being provided on at least two of the proximal portion, the middle portion, and the distal portion of the occluding portion 20.

Referring to fig. 2 and 5 again, in the present embodiment, the covering film 102 is covered outside the anchoring portion 10. The cover 102 may partially or fully cover the anchoring portion 10 to block thrombus within the left atrial appendage from entering the left atrium. Optionally, the covering film 102 is partially coated outside the anchoring portion 10 and is located outside the distal end of the anchoring portion 10, so as to prevent thrombus from falling off from the left atrial appendage from flowing out of the anchoring portion 10 along the blood flow direction, and further avoid the problems of cerebral embolism (cerebral apoplexy), arterial embolism of limbs, etc. caused by the thrombus flowing to the whole body along with blood flow. The support frame 101 includes a first frame 11 and a second frame 21. The first skeleton 11 constitutes an anchor portion 10; the second skeleton 21 constitutes the blocking portion 20. The coating film 102 is coated outside the first skeleton 11. The covering film 102 can also be used for restraining the hemispherical structure at the far end of the first framework 11, so that the hemispherical structure is not easy to deform to enhance structural stability, meanwhile, the direct contact area between the first framework 11 and myocardial tissues is increased, the stimulation effect of materials of the first framework 11 on the myocardial tissues is reduced, and a certain protection effect is achieved.

In this embodiment, the electrode 300 is disposed on the ablation occlusion device 100. Specifically, the electrode 300 is disposed on an outer side surface of the cover film 102 facing away from the support skeleton 101, thereby realizing an insulating arrangement of the electrode 300 and the support skeleton 101. Optionally, the electrode 300 surrounds at least one revolution in the circumferential direction of the covering film 102, thereby enhancing the ablation efficiency of the ablation occlusion device 100.

In some embodiments, the electrode 300 is fixedly connected to the cover film 102. Specifically, the electrode 300 may be fixed to the cover film 102 by adhesion, solution casting, sewing, or the like.

In other embodiments, the electrode 300 is fixedly connected to the cover 102 and the support frame 101. Specifically, the electrode 300 is sewn to the cover film 102 and the support frame 101 by a suture thread. The suture is made of an insulating material to further avoid electrical conduction between the electrode 300 and the support frame 101. The suture material includes, but is not limited to, at least one of polytetrafluoroethylene, polyglycolide, polylactic acid, collagen, nylon suture, polyester suture. Preferably, the suture is a suture made of polytetrafluoroethylene. The mechanical strength of the polytetrafluoroethylene material is high, so that the toughness of the stitching piece is improved.

Referring again to fig. 2, in this embodiment, the electrode 300 may be configured as a wire electrode, or as a sheet electrode. Specifically, when the electrode 300 is a wire electrode and the wire electrode is made in a wave-shaped structure, the wire electrode is fixedly connected to the coating 102 at the peaks and/or the valleys of the wave-shaped structure.

Specifically, the electrode 300 is formed with a plurality of connection points 301 at the peaks and the troughs, and the electrode 300 is connected with the covering film 102 at the plurality of connection points 301 in an adhesive mode (or a sewing mode or a hot pressing mode), so that the displacement of the electrode 300 is avoided, and the accuracy of ablation of the ablation plugging device 100 is improved. In some embodiments, electrode 300 includes a link 302 connecting any adjacent two connection points 301. The electrode 300 is connected with the covering film 102 at a plurality of connection points 301 and a plurality of connecting rods 302 in an adhesive mode (or a sewing mode or a hot pressing mode), so that the stability and the reliability of the connection between the electrode 300 and the covering film 102 are further improved.

In some embodiments, the electrode 300 may also be configured as at least one of a point electrode, a cylindrical electrode, and a ring electrode. The electrode 300 is configured in a wave-like configuration, i.e., the wire electrode is configured in a wave-like configuration. Specifically, the electrode 300 is configured to be formed by surrounding a plurality of zigzag structures or a plurality of sine wave structures, the electrode 300 includes a plurality of peaks and a plurality of valleys, and the peaks and the valleys are alternately arranged in sequence. Wherein the electrode 300 in the form of a wave forms a plurality of turning points in the axial direction thereof, wherein the turning point of the distal end is defined as a peak and the turning point of the proximal end is defined as a trough. The material of the electrode 300 may be, but is not limited to, one of platinum iridium alloy, gold, nickel titanium alloy, stainless steel, etc., or any combination thereof.

In the embodiment shown in fig. 5, electrode 300 is a wire electrode that is positioned one turn around anchor 10. In some variant embodiments, the electrode 300 is a plurality of turns of wire electrodes wound around the periphery of the supporting skeleton 101, the turns of wire electrodes being spaced apart from each other, and the electrode 300 may also be disposed on the blocking portion 20. In the embodiment in which the electrode 300 is in the form of the above-described dot electrode, columnar electrode, cylindrical electrode, ring electrode, or the like, the electrode 300 may be provided in a plurality of turns on the outer periphery of the support frame 101.

Optionally, in some embodiments, when the wire electrode is configured as a wave structure, the wire electrode is fixedly connected to the cover film 102 and the first skeleton 11 at the peaks and/or the valleys of the wave structure, thereby improving the stability and reliability of the connection between the electrode 300 and the cover film 102 and the first skeleton 11.

In other embodiments, when the electrode 300 is configured as a dot electrode, a column electrode, or a cylindrical electrode, the dot electrode, the column electrode, or the cylindrical electrode may be staggered from the first skeleton 11 and fixedly connected to the coating film 102, thereby further improving the insulation performance between the electrode 300 and the supporting skeleton 101.

Referring again to fig. 2 and 5, a plurality of anchors 13 are provided on the support frame 101. A plurality of anchors 13 are provided at intervals along the circumference of the outer surface of the support frame 101. A plurality of anchors 13 are exposed opposite the cover film 102. The plurality of anchors 13 are disposed offset from the electrode 300. The anchors 13 are all disposed on the same side of the electrode 300. The surface of the plurality of anchors 13 is provided with an insulating coating. It will be appreciated that the insulating coating provided on the surface of the anchors 13 is susceptible to breakage, and that when the anchors 13 are relatively close to the electrode 300, the electrode 300 is susceptible to electrically coupling with the anchors 13, so that the anchors 13 are electrically conductive, especially the tips (i.e. free or proximal ends) of the anchors 13 are susceptible to discharge and to generate sparks and eschars, and even cause heart perforation leading to pericardial effusion.

A plurality of anchors 13 may be located on the proximal and/or distal sides of the electrode 300. In other embodiments, the plurality of anchors 13 may be disposed at other reasonable locations of the first scaffold 11, so long as the plurality of anchors 13 are capable of penetrating the inner wall of the left atrial appendage to enhance the anchoring of the ablation occlusion device 100 and do not interfere with the ablation of the inner wall of the left atrial appendage by the electrode 300 on the ablation occlusion device 100, as the application is not specifically limited.

In this embodiment, the plurality of anchors 13 and the first frame 11 are integrally cut and formed, so that the connection stability between the plurality of anchors 13 and the first frame 11 is improved, and the assembly is simplified. In other embodiments, the plurality of anchors 13 may be fixed to the first frame 11 by welding, bonding, mounting structures, or the like. For example, a nitinol wire or a nitinol rod may be used as the anchor 13 and secured to the first armature 11 by means of a sleeve or welding or the like. The plurality of anchors 13 are formed of the same or different material as the first armature 11. Optionally, a plurality of anchors 13 are disposed on a plurality of straight bars in the middle of the first skeleton 11. A plurality of anchors 13 extend outwardly and proximally of the first armature 11. The number of the plurality of anchors 13 is 5 to 15, and is not particularly limited herein.

In some embodiments, a receiving groove 112 is formed on the first skeleton 11 at a position corresponding to each anchor 13. Each anchor 13 is movably received in a corresponding receiving slot 112. Specifically, during the process of delivering the ablation blocking device 100, each anchor 13 is received in a corresponding receiving groove 112, so as to avoid the anchor 13 from scratching the blocking tissue; when the ablation blocking device 100 is released in the tissue area to be blocked, each anchor 13 extends out of the corresponding accommodating groove 112, so that a plurality of anchors 13 can penetrate into the inner wall of the left atrial appendage, and the ablation blocking device 100 can be effectively prevented from falling off.

In the present embodiment, a plurality of anchors 13 are provided on the first armature 11 of the anchor 10. The plurality of anchors 13 are arranged continuously or at intervals in the axial direction of the outer surface of the first frame 11. Specifically, the plurality of support bars 1010 of the anchor 10 include a plurality of first struts 1010a and a plurality of second struts 1010b. A plurality of first struts 1010a are provided at the middle of the anchoring portion 10, a plurality of second struts 1010b are provided at the distal and proximal sides of the anchoring portion 10, and both ends of each first strut 1010a are connected to the corresponding second struts 1010b. Each anchor 13 is disposed on a respective first strut 1010 a. The shape of the first struts 1010a may be, but not limited to, rod-shaped, and the shape of the second struts 1010b may be, but not limited to, V-shaped, W-shaped, Z-shaped, or S-shaped. Each first strut 1010a may be connected to a plurality of second struts 1010b to improve the overall support strength and resiliency of the anchor 10. In this embodiment, two second struts 1010b are connected to one end of each first strut 1010 a. Each anchor 13 is disposed on an outer surface of a corresponding first strut 1010 a.

Referring to fig. 2 and 7 together, fig. 7 is a schematic structural view of a third embodiment of an ablation occlusion device 100c of the ablation occlusion system 1000 of fig. 1. In some embodiments, anchor 13 penetrates through covering membrane 102 and is spaced from electrode 300. Optionally, the wave crests and wave troughs of the plurality of anchor spines 13 and the electrode 300 are staggered, so that the plurality of anchor spines 13 and the electrode 300 are prevented from being shorted, and after the ablation plugging device 100c is implanted into the left atrial appendage, the plurality of anchor spines 13 can penetrate into the inner wall of the left atrial appendage to further anchor the ablation plugging device 100c, and the ablation plugging device 100c can be effectively prevented from falling off.

Referring to fig. 7, in the present embodiment, a plurality of anchors 13 are disposed on the proximal side of the electrode 300, and each anchor 13 is disposed between two adjacent valleys of the electrode 300, so as to ensure that each portion of the plurality of anchors 13 and the electrode 300 maintains an insulation distance, thereby avoiding a short circuit between the electrode 30 and the plurality of anchors 13 and the supporting frame 101. Alternatively, the proximal ends of the plurality of anchors 13 are approximately aligned with the positions of the valleys of the electrode 300 in the circumferential direction of the anchor portion 10, i.e., the proximal ends of the plurality of anchors 13 are approximately at the same level as the valleys of the electrode 300. In the axial direction of the anchoring portion 10, the plurality of anchors 13 is approximately aligned with the peaks of the electrode 300, i.e. the peaks of the electrode 300 are diametrically opposed to the respective anchors 13.

Referring to fig. 2 and 8 together, fig. 8 is a schematic structural view of a fourth embodiment of an ablation occlusion device 100e of the ablation occlusion system 1000 of fig. 1. In some embodiments, the amplitude of the electrode 300 may be reduced, i.e., the electrode 300 may occupy a smaller range in the axial direction, the fluctuation may be more gradual, and/or the distance between the electrode 300 and the anchor 13 may be increased, so that one anchor 13 may be provided at each position of the first struts 1010a of the first skeleton 11, thereby improving the anchoring performance of the anchor 10.

In this embodiment, the electrode 300 is a wire electrode, and the wire electrode is made in a wave-shaped structure. The wave crests and wave troughs of the wave structure are staggered with the first framework 11, so that the situation that the distance between the wave crests and the wave troughs of the electrode 300 and the first framework 11 is too short, and the risk of short circuit between the wave crests and the wave troughs of the electrode 300 and the supporting framework 101 after the wave crests and the wave troughs of the electrode 300 are fixedly arranged (such as by bonding or sewing) on the coating film 102 is avoided, and the insulation performance between the electrode 300 and the supporting framework 101 is further improved.

A plurality of anchors 13 are provided at the distal end side of the electrode 300. At least two anchors 13 are correspondingly arranged between two adjacent peaks of the electrode 300, so that the anchoring performance of the anchoring portion 10 is further improved by increasing the number of the anchors 13. In this embodiment, two anchors 13 are correspondingly disposed between two adjacent peaks of the electrode 300. The free end of each anchor 13 is spaced from the electrode 300, so that the electrode 300 is electrically coupled with the anchors 13 to avoid the phenomena of discharge of the tips of the anchors 13, spark generation and eschar generation, and pericardial effusion caused by cardiac perforation.

In some embodiments, each anchor 13 is disposed between two adjacent peaks of the electrode 300, so as to ensure that each portion of the plurality of anchors 13 and the electrode 300 maintains an insulation distance, thereby avoiding a short circuit between the electrode 30 and the plurality of anchors 13 and the supporting skeleton 101. Alternatively, the distal ends of the plurality of anchors 13 are approximately aligned with the position of the peak of the electrode 300 in the circumferential direction of the anchor portion 10, i.e., the distal ends of the plurality of anchors 13 and the distal end of the electrode 300 are located at approximately the same height on the anchor portion 10. In the axial direction of the anchor 10, the plurality of anchors 13 is approximately aligned with the valleys of the electrode 300, i.e. the valleys of the electrode 300 are diametrically opposed to the respective anchors 13.

As shown in fig. 8, in some embodiments, the ablation blocking device 100e further includes an ablating member 50 disposed on the supporting framework 101 for ablating the tissue to be ablated, and when the ablation blocking device 100e is externally connected to a pulse generator for outputting pulse energy, the pulse generator can transmit pulse energy with different polarities to the electrode 300 and the ablating member 50, so that the ablation blocking device 100e performs bipolar ablation on the tissue. In addition, a pulse ablation electric field can be generated between the electrode 300 and the ablating member 50, and myocardial tissues within a certain electric field intensity range are ablated by pulse energy sources, so that irreversible electroporation is realized.

Optionally, the ablating member 50 and the plurality of anchors 13 are disposed on either side of the electrode 300. It will be appreciated that the insulating coating provided on the surface of the anchors 13 is susceptible to breakage, and if a plurality of anchors 13 are provided between the ablating member 50 and the electrode 300, the tips of the anchors 13 are susceptible to discharge under the action of the pulsed ablating electric field generated between the electrode 300 and the ablating member 50, and sparks and eschars are generated, even causing heart perforation to cause pericardial effusion. Therefore, in the embodiment of the present application, the plurality of anchors 13 are disposed on the distal end side of the electrode 300, so that the problem that the tips of the plurality of anchors 13 are affected by the ablation electric field to cause the tip discharge is reduced, and the safety, stability and ablation effect of the ablation blocking device 100e are improved.

The ablating member 50 is disposed on the occluding portion 20. Specifically, in some embodiments, the ablating member 50 may be fixed on the second skeleton 21 independently of the second skeleton 21 of the blocking portion 20, i.e. an electrically conductive member additionally provided on the second skeleton 21. Optionally, the ablating member 50 is arranged insulated from the second skeleton 21, so as to avoid shorting the ablating member 50 to the electrode 300. The surface of the second bobbin 21 may be provided with an insulating coating or an insulating sleeve. Optionally, the ablating member 50 is disposed on the circumferential surface of the occluding portion 20 so as to be as close as possible to the left atrial appendage ostium tissue, and the ablating member 50 encloses at least one ring in the circumferential direction of the ablation occluding device 100e to form an annular ablation zone for the left atrial appendage ostium.

In some embodiments, the ablating member 50 is provided as part or all of the second skeleton 21 of the occluding portion 20. In this embodiment, the ablating member 50 is used as a part of the second skeleton 21 of the blocking portion 20, for example, the ablating member 50 is used as an edge portion of the second skeleton 21 away from the anchoring portion 10, so that the ablating member 50 is convenient to abut against the left atrial appendage tissue to improve the success rate of ablation. The part of the second skeleton 21 corresponding to the ablating member 50 is not subjected to insulation treatment, and the rest part of the second skeleton 21 except for the ablating member 50 is subjected to insulation treatment, so that the accuracy of ablation by using the ablating member 50 is ensured.

In some embodiments, all of the second armature 21 may also serve as an ablating member 50. In the case where the external ablation energy source is a radio frequency signal source, or a microwave physiotherapy instrument, the second skeleton 21 may transmit a single radio frequency signal to the inner wall tissue of the left atrial appendage. It is understood that the ablating member 50 and the electrode 300 can each be configured to transmit different radio frequency energy, or microwave energy, or that the ablating member 50 and the electrode 300 each can each transmit pulse energy, microwave energy, or any combination of pulse energy. In particular, the entire second scaffold 21 of the occlusion 20 is used for delivering ablation energy for annular ablation or for acquiring tissue physiological signals for mapping. When the anchoring portion 10 is anchored in the left atrial appendage, the blocking portion 20 can completely block the entrance of the left atrial appendage, blocking thrombus inside the left atrial appendage, and effectively preventing thrombus from entering the left atrium. Meanwhile, the plugging part 20 can well ablate the tissue on the inner wall of the inlet of the left auricle, and has good ablation effect. Specifically, the left auricle mouth tissue is more regular relative to the inner tissue of the left auricle, the surface is smooth, the left auricle mouth is ablated, a complete ablation zone is formed at the mouth, and further the left auricle is electrically isolated from the left atrium thoroughly at the left auricle mouth.

Referring again to fig. 2 and 5, the anchor portion 10 and the blocking portion 20 are insulated from each other. In some embodiments, the support frame 101 further includes an insulating connector 40. The anchor portion 10 and the blocking portion 20 are connected and electrically isolated by the insulating connector 40, avoiding a short circuit between the ablating member 50 and the electrode 300. The insulating connector 40 is provided between the anchor portion 10 and the blocking portion 20 to insulate the anchor portion 10 from the blocking portion 20. In some embodiments, the insulating connector 40 may be omitted, and the connection between the anchoring portion 10 and the plugging portion 20 is provided with a free insulating section, so as to achieve insulating performance therebetween. The first frame 11 is fixedly connected with the second frame 21, so that the plugging portion 20 is integrally connected with the anchoring portion 10. In the present embodiment, the first frame 11 and the second frame 21 are fixedly connected together by the insulating connecting member 40.

Specifically, the distal end of the first armature 11 gathers toward the center of the anchor portion 10 and extends along the central axis of the ablation occlusion device 100 to form a first connection portion 111. The second armature 21 gathers on the side near the anchoring portion 10 and extends along the central axis of the ablation occlusion device 100 to form a second connection portion 211. The first connection portion 111 and the second connection portion 211 are fixed to the insulating connector 40, thereby achieving a fixed connection between the anchor portion 10 and the blocking portion 20.

In the present embodiment, the insulating connector 40 is configured as an insulating sleeve. The insulating sheath is sleeved outside the first connecting portion 111 and the second connecting portion 211. The anchoring portion 10 is formed by cutting a tubular or plate-shaped material having a shape memory effect by laser, thereby improving the support of the anchoring portion 10 and further improving the reliability of the anchoring portion 10 for anchoring the ablation occlusion device 100 to the left atrial appendage. The plugging portion 20 is formed by braiding braided wires with a shape memory effect, and the braided wires are gathered at one side close to the anchoring portion 10 and hinged into a strand and extend outwards to form a second connecting portion 211, so that the plugging portion 20 is conveniently covered on the mouth of the left auricle to block and isolate the left atrium from the left auricle, and thrombus in the left auricle is prevented from entering the left atrium and the plugging portion 20 is prevented from damaging the left atrium. Wherein at least part of the insulating connector 40 is made of an insulating material, such as an insulating tube. One end of the anchor portion 10 is connected to the distal side of the insulating connector 40, and the blocking portion 20 is connected to the proximal side of the insulating connector 40.

It can be appreciated that the first connection portion 111 and the second connection portion 211 may be formed by braiding a plurality of braided wires, and an insulating coating is disposed on an outer surface of each braided wire or the whole braided body of the first connection portion 111 and the second connection portion 211, so that electrical connection between the anchoring portion 10 and the plugging portion 20 is further avoided, and a braiding manner is not required to be improved, so that a processing technology is simplified.

In some embodiments, the first skeleton 11 and the second skeleton 21 may be fixedly connected directly by welding. In other embodiments, when the first frame 11 and the second frame 21 are both made by wire braiding and heat setting, the first frame 11 and the second frame 21 may be integrally braided, or may be fixedly connected together by welding or by connecting pipes after being separately braided. In other embodiments, the portion of the second armature 21 of the occluding portion 20 adjacent to the anchoring portion 10 is formed by braiding, and the portion of the second armature 21 of the occluding portion 20 distal from the anchoring portion 10 is formed by cutting.

The first frame 11 has a first through hole 110 extending in the axial direction, the second frame 21 also has a second through hole 210 extending in the axial direction, and the insulating connector 40 has a third through hole 401 extending in the axial direction. When the first skeleton 11 is fixedly connected to the second skeleton 21, the first through hole 110 of the first skeleton 11, the second through hole 210 of the second skeleton 21 and the third through hole 401 of the insulating connector 40 are correspondingly communicated, so as to form a channel 1001 penetrating through opposite ends of the ablation plugging device 100 in the axial direction. When the ablation occlusion device 100 is detachably connected to the delivery device 200, the channel 1001 communicates with the lumen of the sheath 201.

Referring again to fig. 5, the second frame 21 constituting the blocking portion 20 is disc-shaped and takes on a trapezoidal shape in the view of the drawing shown in fig. 5, i.e., in the plane through which the axis of the supporting frame 101 passes. Specifically, the blocking portion 20 includes a proximal disc face 23, a distal disc face 24, and a waist portion 25 connected between the proximal disc face 23 and the distal disc face 24. The proximal disc surface 23 is disposed near the distal disc surface 24, and both the proximal disc surface 23 and the distal disc surface 24 are substantially planar, and the radial dimension of the proximal disc surface 23 is greater than the radial dimension of the distal disc surface 24. The waist 25 extends in a tapered tubular shape between a proximal end and a distal end, the radial dimension of the proximal end of the waist 25 being smaller than the radial dimension of the distal end of the waist 25. The waist 25 is intended to rest against the left atrial appendage tissue.

To improve the insulation between the electrode 300 and the ablating member 50, the first skeleton 11 constituting the anchor portion 10 and the second skeleton 21 constituting the sealing portion 20 are prevented from being electrically conducted to each other, and the distal portion of the second skeleton 21, that is, the portion facing the anchor portion 10 is subjected to insulation treatment. Specifically, the second armature 21 includes an insulating section 27 and an ablation section 28. Wherein the ablation section 28 is arranged at a side of the insulation section 27 remote from the first skeleton 11. The portion of the second skeleton 21 located in the ablation section 28 is used as an ablating member 50, i.e. the portion of the second skeleton 21 located in the ablation section 28 is used for delivering ablation electrical energy to the tissue, the surface of which is electrically conductive and does not require an insulating treatment. The part other than the ablation section 28 is an insulation section 27, and the surface of the part of the second skeleton 21 located in the insulation section 27 is not used for ablation of tissues and needs insulation treatment. The insulating section 27 can improve the insulating performance between the first skeleton 11 forming the anchoring portion 10 and the second skeleton 21 forming the blocking portion 20 on the one hand, and on the other hand, the insulating section 27 can reduce the proportion of the ablating members 50 in the blocking portion 20, namely reduce the conductive area of the ablating members 50, so that the tissue is ablated conveniently by concentrated ablation energy, the ablation depth and the ablation effect are ensured, the excessive conductive area of the ablating members 50 is avoided, the ablation energy is dispersed, and the ablation depth is shallower and cannot reach the transmural annular ablation zone.

Further, the ablation section 28 is a portion disposed at the circumferential edge of the occluding portion 20 for abutting against the left atrial appendage ostium tissue to facilitate ablation of the ostium tissue. In some embodiments, the ablation section 28 may be disposed at the waist 25 of the second armature 21. In other embodiments, ablation sections 28 are disposed at waist 25 of second scaffold 21 and proximal disc surface 23. In other embodiments, the ablation section 28 is disposed on the proximal disc surface 23 of the second scaffold 21; alternatively, the ablation section 28 may also be disposed on a portion of the distal disc surface 24, such as a portion of the distal disc surface 24 adjacent the waist 25. Optionally, the ablation section 28 is disposed on the proximal disc surface 23 and the waist 25 of the second skeleton 21, which have relatively large radial dimensions, not only improves the ablation efficiency, but also increases the distance between the ablation section 28 and the electrode 300, thereby improving the insulation performance therebetween.

The insulating section 27 is provided at the distal end disk surface 24 of the second chassis 21, particularly at a portion of the distal end disk surface 24 that easily contacts the first chassis 11, such as a portion of the second chassis 21 that overlaps with the projection of the first chassis 11 in the axial direction. The ablation section 28 is arranged in an insulating manner with the first skeleton 11 through the insulation section 27, so that the insulation performance between the first skeleton 11 and the second skeleton 21 is improved.

The second skeleton 21 is made of a conductive wire weave, and as shown in fig. 5, the ablation section 28 is configured as a dense mesh weave structure made of woven wires, which are wires. Each support bar 1010 of the second skeleton 21 in the insulation section 27 is a strand of braided wires formed by combining a plurality of braided wires, for example, the braided wires are combined into a bundle by braiding, bonding or fixing by using other devices, and each strand of braided wires is insulated, so that the insulation treatment is more convenient than the insulation treatment of each braided wire. Specifically, each braided wire in the insulation section 27 may be combined into one strand without insulation treatment, and then an insulation coating layer is provided on the outer surface of the whole braided body or an insulation sleeve is sleeved on the outer surface of the whole braided body. In some embodiments, each braided wire is provided with an insulating coating and then combined into one strand, and an insulating sleeve can be sleeved on the periphery of one strand of braided wire, so that the insulating performance of each supporting rod 1010 of the second framework 21 in the insulating section 27 is improved.

In other embodiments, the plurality of braided wires in the insulating section 27 are braided (spliced) into a strand, wherein the periphery of each braided wire is sleeved with an insulating sleeve; or, the plurality of braiding wires are braided into one strand, and the periphery of the whole braiding body is sleeved with an insulating sleeve, so that the insulating performance between the insulating section 27, the ablation section 28 and the first framework 11 is realized.

In some embodiments, the ablation section 28 is correspondingly provided with an ablating member, and the portion of the second armature 21 located in the ablation section 28 may be insulated or may not be insulated. In such an embodiment, the manner of the insulation process may be described in detail with reference to the above-described insulation section 27, and is not particularly limited herein.

Referring to fig. 2 and 9 together, fig. 9 is a top view of the ablation occlusion device 100 of fig. 2. In some embodiments, the support frame 101 is used for being implanted into a notch of the left atrial appendage, the covering film 102 is coated on the distal end of the support frame 101, and the covering film 102 is provided with a plurality of micropores 33 for blood flow to pass through in a region other than the position corresponding to the electrode 300, so that the phenomenon of short circuit caused by electrical conduction between the electrode 300 and the support frame 101 at the micropores 33 is avoided. The size of each micropore 33 is smaller than 0.25mm, so that thrombus in the left auricle is limited to flow out of the ablation plugging device 100, normal circulation is formed between the left auricle and blood in the left atrium, and the problems of cerebral embolism (cerebral apoplexy), arterial embolism of limbs and the like caused by blood flowing everywhere in the whole body after the left auricle thrombus falls off are avoided.

Referring to fig. 1 and 10 together, fig. 10 is a schematic structural view of a fifth embodiment of an ablation occlusion device 100f of the ablation occlusion system 1000 of fig. 1. The structure of the ablation occlusion device 100f in the sixth embodiment is similar to that of the ablation occlusion device 100e in fig. 9, except that the ablation occlusion device 100f further includes an insulating film 106. The insulating film 106 is coated on the outer surface of the second frame 21, thereby improving the insulating performance between the first frame 11 and the second frame 21.

Specifically, the ablating member 50 is disposed on the proximal side of the occluding portion 20 and is exposed with respect to the insulating film 106 to facilitate tissue contact for ablating tissue. The ablating member 50 is configured in a loop shape to form an annular ablation zone at the left atrial appendage portion to enhance ablation efficiency. The insulating film 106 is arranged on the distal end side of the plugging portion 20, namely, the insulating film 106 is arranged on one side, close to the anchoring portion 10, of the second framework 21, so that insulativity between the anchoring portion 10 and the plugging portion 20 is enhanced, short circuits between the ablation element 50 and the first framework 11 and between the ablation element 50 and the electrode 300 caused by the fact that the first framework 11 contacts with the distal end of the second framework 21 are avoided, safety and reliability of the ablation plugging device 100f are guaranteed, and the insulating film 106 is used for insulating the surface of the part, which is not used as the ablation element 50, of the second framework 21 in the plugging portion 20, proportion of the ablation element 50 in the plugging portion 20 is reduced, namely, the surface area of the ablation element 50 is reduced, ablation energy is concentrated in a smaller ablation range, and ablation depth and ablation effect are guaranteed. In some embodiments, the insulating film 106 may also be disposed on the distal and proximal sides of the occluding portion 20. In some embodiments, the ablating member 50 may be disposed on the insulating film 106, and the ablating member 50 and the first skeleton 11 are disposed at intervals, so as to avoid a short circuit caused by electrical conduction between the ablating member 50 and the first skeleton 11, and ensure an ablation effect of the ablation plugging device 100 f.

Referring to fig. 1 and 11-12 together, fig. 11 is a schematic structural view of a sixth embodiment of an ablation occlusion device 100g of the ablation occlusion system 1000 of fig. 1; fig. 12 is a schematic structural view of the support frame 101 of the ablation occlusion device 100g of the ablation occlusion system 1000 of fig. 11. The structure of the ablation occlusion device 100g in the sixth embodiment is similar to that of the ablation occlusion device 100e in the fourth embodiment, except that the support frame 101 is constructed as a single-layer mesh disc. Wherein the profile of the support skeleton 101 may be frustoconical with a diameter that decreases from the proximal end to the distal end. The outline of the supporting frame 101 may be a disk shape, a cylinder shape, or the like. The outline of the supporting framework 101 is in a frustum shape, the maximum diameter of the supporting framework is larger than that of the left auricle opening, and the circumferential surface of the supporting framework 101 is a conical surface. After the ablation plugging device 100g is implanted into the left auricle, the distal end of the supporting framework 101 enters the left auricle, the position with the largest diameter of the supporting framework 101 is plugged at one side of the left auricle opening adjacent to the left atrium, and myocardial tissue of the left auricle opening is attached to the conical surface of the supporting framework 101 around the circumferential direction.

The support armature 101 includes a distal section 1011 and a proximal section 1012 spaced from the distal section 1011. A distal section 1011 is formed within the anchor 10 and a proximal section 1012 is formed within the occlusion 20. In this embodiment, the electrode 300 is disposed corresponding to the distal section 1011 and the ablating member 50 is disposed corresponding to the proximal section 1012. The distal section 1011 serves as a carrying section or insulating section, i.e. the surface of the support skeleton 101 corresponding to the distal section 1011 is provided with an insulating coating or insulating sleeve. The proximal section 1012 serves as an ablation section, i.e. the portion of the support armature 101 corresponding to the proximal section 1012 is used as an ablator 50, i.e. the portion of the second armature 21 located in the proximal section 1012 can be electrically conductive and used for delivering ablation electrical energy to tissue. In other embodiments, the ablating member 50 is additionally disposed in the second skeleton 21 at the proximal section 1012, independent of the second skeleton 21.

Optionally, the distal section 1011 is used as a carrying section, i.e. the portion of the first skeleton 11 located in the distal section 1011 is insulated, and correspondingly, the portions of the second skeleton 21 except the portion located in the proximal section 1012 are insulated, so as to ensure the insulation performance between the electrode 300 and the ablation member 50, thereby improving the safety and stability of the ablation plugging system 1000. In some embodiments, the distal section 1011 and the proximal section 1012 may both be load bearing sections or insulating sections.

In some embodiments, the support frame 101 further comprises an insulating section 1013 located between the distal section 1011 and the proximal section 1012. The insulating section 1013 is made of an insulating material, a portion of the first skeleton 11 located in the distal section 1011 is made of a metal material, and is melt-connected to the skeleton in the insulating section 1013, and a portion of the second skeleton 21 located in the proximal section 1012 is made of a metal material, and is melt-connected to the skeleton in the insulating section 1013. In some embodiments, the portion of the first armature 11 located in the distal section 1011 and the portion of the second armature 21 located in the proximal section 1012 are integrally made of the same material. In some embodiments, the portions of the support frame 101 that are located on the insulating section 1013 and the distal section 1011 are both made of an insulating material, so that the surface of the distal section 1011 does not need to be insulated.

In this embodiment, the covering film 102 is coated on the distal end of the first skeleton 11. In this embodiment, the covering film 102 covers the entire outer surface of the anchoring portion 10, and the blocking portion 20 is exposed opposite to the covering film 102. The distal end portion of the second bobbin 21 constituting the blocking portion 20 is insulated, thereby enhancing insulation between the supporting bobbin 101 and the electrode 300 and the ablating member 50. In such an embodiment, the manner of the insulation process may be described in detail with reference to the ablation section described above, and is not specifically limited herein.

Referring to fig. 1 and fig. 13-14, fig. 13 is a schematic structural view of a second embodiment of the ablation occlusion system 1000a of fig. 1; fig. 14 is a schematic structural view of a portion of the structure of the ablation occlusion system 1000a of fig. 13. The structure of the ablation occlusion system 1000a in the second embodiment is similar to that of the ablation occlusion system 1000 in the first embodiment, except that the electrode 300 is fixed to the delivery device 200.

In this embodiment, the delivery device 200 further includes a movable conduit 60. The support skeleton 101 is provided with a channel 1001 penetrating axially, the movable catheter 60 is movably arranged in the channel 1001, the movable catheter 60 comprises a catheter body 61, the electrode 300a is arranged at the distal end of the catheter body 61, and the distal end of the movable catheter 60 is used for being released at the distal end side of the support skeleton 101. The catheter body 61 is provided with a plurality of electrodes 300a arranged at intervals, thereby realizing ablation treatment of the tissue to be ablated.

The movable conduit 60 is generally tubular in configuration. The electrode 300a is hermetically connected to the catheter body 61 to prevent blood or other body fluid from entering the interior of the catheter body 61 when the movable catheter 60 is operated in a human body, thereby ensuring the stability of the operation of the electrode 300a. The junction between the electrode 300a and the catheter body 61 is fixed and sealed by means of adhesive. Specifically, in the present embodiment, the movable catheter 60 includes a tubular catheter body 61 and a plurality of tubular or ring-shaped electrodes 300a provided on the catheter body 61 at intervals. The tubular or annular electrode 300a is sleeved outside the catheter body 61, and the outer surface of the tubular or annular electrode 300a is connected with the outer peripheral surface of the catheter body 61 to form a flat surface, so that the smoothness of conveying the movable catheter 60 is improved. In some embodiments, the electrode 300a may also be in a dot-like, hemispherical, blunt, or smooth protruding configuration, thereby increasing the contact surface of the electrode 300a with the targeted tissue area, thereby improving ablation effectiveness. In order to reduce the energy loss of the discharge, the material of the electrode 300a may include, but is not limited to, at least one of platinum iridium alloy, pure gold, silver, and the like, which is a high conductive material.

The proximal end of catheter body 61 passes through the lumen of sheath 201 and is connected to control handle 202. In some embodiments, catheter body 61 includes an adjustable bend section 611 at the distal end of catheter body 61 and a main section 612 at the proximal end of catheter body 61. The adjustable bend section 611 is fixedly attached to the distal end of the main body section 612. The hardness of the adjustable bend section 611 is less than or equal to the hardness of the main body section 612, so that the main body section 612 can support the adjustable bend section 611, thereby facilitating transportation of the catheter body 61 to the target tissue. The catheter body 61 is made of a polymeric material including, but not limited to, at least one of Polyamide (PA), polyether block Polyamide (Polyether block amide, pebax), nylon, thermoplastic polyurethane elastomer (Thermoplastic urethane, tpu), and the like. A plurality of electrodes 300a are provided on the adjustable bend 611 of the catheter body 61 to enable ablation of different ablated tissue areas.

Wherein the catheter body 61 further comprises a transition section 613 connecting the adjustable bend section 611 and the main section 612. The main section 612, the adjustable bend section 611 and the transition section 613 are connected in sequence from the proximal end to the distal end of the catheter body 61. The adjustable bend 611 and the main body 612 are smoothly connected by a transition 613.

Sheath 201 includes an inner tube 2011 and an outer tube 2012 coaxially disposed, inner tube 2011 being disposed through the lumen of outer tube 2012. In the delivery state, the movable conduit 60 is entirely housed in the inner tube 2011. By pushing the inner tube 2011 along the channel 1001 by the control handle 202 such that the distal end of the inner tube 2011 protrudes from the distal end of the support frame 101 and then releasing the adjustable bend 611 of the movable catheter 60 from the distal end of the inner tube 2011, the adjustable bend 611 may be subjected to a bending process such that the adjustable bend 611 is bent into a suitable shape, such as the ring shape shown in fig. 13-14.

The adjustable bend 611 of the catheter body 61 is configured in a ring-shaped configuration when the distal end of the movable catheter 60 is released on the distal side of the support frame 101. In other words, the adjustable bend 611 of the catheter body 61 extends radially outwardly from the distal end of the main section 612. The adjustable bend 611 extends annularly around the circumference of the body section 612 from the end of the transition section 613 remote from the body section 612. A plurality of electrodes 300a are spaced apart on the transition section 613 and the adjustable bend section 611.

In some embodiments, the adjustable bend 611 is entirely helically wrapped around the circumference of the body 612, which may be a planar spiral around the body 612 or may be gradually helically wrapped in a cylindrical or conical shape along the axis of the body 612. The shape of the adjustable bend 611 is designed according to the ablation site of the tissue to be ablated, and is not particularly limited in this application. In some embodiments, among the plurality of electrodes 300a, adjacent electrodes 300a may transmit the same ablation power; different ablative electrical energy, such as pulsed ablative electrical energy of different polarities, may also be delivered. Specifically, the plurality of electrodes 300a includes a plurality of positive electrodes 301a and a plurality of negative electrodes 302a. The number of positive electrodes 301a and negative electrodes 302a each include a plurality. The positive electrodes 301a and the negative electrodes 302a are alternately arranged along the extending direction of the catheter body 61 and are spaced from each other, so that a plurality of pulse electric fields can be formed to form an annular ablation region when the positive electrodes 301a and the negative electrodes 302a are discharged, and the ablation treatment effect and efficiency of the target tissue region are improved. The alternating arrangement of the plurality of positive electrodes 301a and the plurality of negative electrodes 302a may be such that the even-numbered number of electrodes counted from the proximal end to the distal end thereof in the extending direction of the catheter body 61 is the positive electrodes 301a, the odd-numbered number of electrodes is the negative electrodes 302a, or vice versa. In this way, when the energy generating device transmits ablation energy to the plurality of positive electrodes 301a and the plurality of negative electrodes 302a, the electrodes 300a discharged at the same time can be more uniformly distributed along the extending direction of the catheter body 61, thereby facilitating uniform transmission of ablation energy to a plurality of sites of the target tissue region at the same time to enhance the ablation effect.

In other embodiments, the active catheter 60 may also be used to acquire electrophysiological signals inside the left atrial appendage, and accordingly, the electrode 300a may be used for mapping. Specifically, the electrode 300a is electrically connected with the external marking device, and senses the physiological activity of the tissue to be ablated of the ablation site, so as to judge whether the tissue to be ablated needs to be located at the ablation site, so that the tissue to be ablated is ablated more pertinently, the ablation effect is improved, the treatment effect of the operation is improved, and a more exact basis is provided for accurate positioning of the operation.

In some embodiments, portions of the plurality of electrodes 300a are used to achieve ablation and portions are used to achieve mapping functions.

In some embodiments, the plurality of electrodes 300a are used only to perform mapping functions and are not used to perform ablation functions.

In some embodiments, the adjustable bend 611 is a pre-bend, i.e., the adjustable bend 611 has flexibility, is pre-shaped into a ring shape, is ring-shaped in a natural state, and in a delivery state, the adjustable bend 611 is straight rod-shaped under the constraint of the inner tube, and the adjustable bend 611 returns to a ring shape after being released from the inner tube. The adjustable bend 611 is annular, so that a plurality of electrodes 300a in the adjustable bend can be conveniently abutted against the inner wall of the left auricle tissue, and the electrodes 300a can be conveniently ablated and mapped.

In some embodiments, an adjustment member is disposed within catheter body 61 for adjusting the curvature of adjustable bend 611. Alternatively, the adjustment member may be pre-shaped such that the adjustable curved section 611 is deformed to a pre-set shape, such as, but not limited to, a ring shape, a U-shape, a C-shape, etc., following the shape of the adjustment member after being released at the distal side of the support frame.

Preferably, the plurality of positive electrodes 301a and the plurality of negative electrodes 302a are arranged at equal intervals, so that the formed ablation electric field is relatively uniform, and the ablation depth is basically consistent; when the electrode 300a is used for mapping the electric signals, the electrophysiological signals can be conveniently collected at the circumferential position of the inner cavity of the left auricle, so that the problem that the local position is not mapped is avoided. The equidistant design of the electrodes 300a balances the overall stress of the catheter body 61, and further promotes the deformation of the distal end of the catheter body 61 along with the preset shape corresponding to the adjusting piece.

The support skeleton 101 may be constructed as a double layer net tray, i.e. the anchoring portion 10 and the blocking portion 20 are constructed as a double layer tray-like structure. The electrode 300 arranged on the catheter body 61 is arranged in an insulating way with the supporting framework 101 through the coating 102, so that the problem that the supporting framework 101 damages the tissue to be ablated due to the fact that the electrode 300 is electrically conducted with the supporting framework 101 in an electrified state is avoided. Specifically, the covering film 102 is coated on the distal end of the supporting framework 101. In the present embodiment, the cover film 102 covers the entire outer side surface of the anchor portion 10. In some embodiments, the cover film 102 covers a portion of the outer side of the anchor 10.

In some embodiments, a visualization positioner is provided on the catheter body 61 to further enhance the positioning effect on the distal portion of the catheter body 61. Wherein, the material of the developing structure comprises at least one of tantalum alloy, platinum iridium alloy, platinum tungsten alloy and gold.

In some embodiments, the ablation occlusion system 1000a further includes an ablating member 50 disposed on the support frame 101 for ablating tissue to be ablated, as described in the above embodiments. In this embodiment, the ablating member 50 is annular or is looped. The ablating member 50 is disposed on the supporting frame 101 at a position not covered by the covering film 102. Specifically, the ablating member 50 is disposed on the occluding portion 20. Optionally, the ablating member 50 is disposed on at least one of the proximal disc face 23, the distal disc face 24, and the waist portion 25 of the second skeleton 21 constituting the occluding portion 20.

In some embodiments, the ablation plugging system 1000a further includes an insulating coating wrapped around the outer surface of the second skeleton 21, where the insulating coating is disposed on the distal side of the plugging portion 20 near the anchoring portion 10, so as to enhance the insulation performance between the first skeleton 11 and the second skeleton 21 and the ablating member 50. The ablating member 50 is provided at a position on the supporting skeleton 101 not covered with the insulating film. Specifically, the ablating member 50 is disposed on the circumferential edge of the second skeleton 21, and is exposed opposite the insulating film 106.

In other embodiments, the ablating member 50 is disposed on an outer side of the cover 102 facing away from the support frame 101. In this embodiment, the ablating member 50 is disposed on the anchor portion 10, and the covering film 102 is wrapped around the outer side surface of the first skeleton 11 constituting the anchor portion 10.

In other embodiments, a plurality of ablative elements 50 are provided on the anchor 10 and occluding portion 20, respectively. In order to enhance the insulation between the support skeleton 101 and the electrode 300, the surface of the support skeleton 101 corresponding to the ablation member 50 is subjected to insulation treatment, and the manner of the insulation treatment is specifically referred to the specific description of the foregoing embodiment, which is not repeated here.

In the present embodiment, the first frame 11 constituting the anchor portion 10 is integrally formed with the second frame 21 constituting the blocking portion 20 to simplify the manufacturing process.

It should be noted that the electrode 300 and the ablating member 50 may or may not operate simultaneously. Both the electrode 300 and the ablating member 50 can be used to ablate tissue or map electrophysiological signals.

It will be appreciated that the active catheter 60 of the embodiment shown in fig. 13-14 may also be used in the ablation occlusion device 100 shown in fig. 2, as well as in the ablation occlusion device 100g shown in fig. 11.

The following description will be given by taking the application of the movable catheter 60 to the ablation occlusion device 100 shown in fig. 2 as an example.

Referring to fig. 15, fig. 15 is a schematic structural diagram of a third embodiment of the ablation occlusion system 1000b of fig. 1. The ablation blocking device 100 comprises a support framework 101 and a covering film 102, the conveying device 200 comprises a movable catheter 60, an electrode 300a is arranged at the distal end of the movable catheter 60, and the electrode 300a is used for ablation of tissues or electrophysiological signal mapping. The distal end of the active catheter 60 can be disposed through a channel formed by the support frame 101 and can extend from the distal end of the support frame 101 for apposition to tissue, preferably with the electrode 300a being capable of resting against the tissue surface. After ablation or mapping is completed, the distal end of the active catheter 60 can be moved proximally from the channel of the support matrix 101, withdrawn from the body.

The supporting frame 101 is made of a metal material, and in order to avoid mutual electrical coupling between the electrode 300a and the supporting frame 101, the coating 102 is disposed on the outer side of the supporting frame 101, i.e. the coating 102 is sandwiched between the supporting frame 101 and the electrode 300 a.

In the present embodiment, the ablation occlusion device 100 is provided with an ablating member 50, and the ablating member 50 includes a first ablating member 51 and a second ablating member 52. The first ablating member 51 is spaced apart from the second ablating member 52. A pulse ablation electric field can be generated between the first ablation member 51 and the second ablation member 52, and myocardial tissues within a certain electric field intensity range are ablated by pulse energy sources, so that irreversible electroporation is realized, and the ablation effect of the ablation plugging device 100e is improved.

Wherein the first ablating member 51 is arranged at the anchoring portion 10. Specifically, the first ablating member 51 is disposed on a side of the covering film 102 facing away from the first supporting skeleton 11. Specifically, the first ablating member 51 is fixed to the outside of the covering film 102 and is disposed at a distance from the electrode 300 a. The first ablating member 51 may be a conductive member fixedly disposed on the outer surface of the cover film 102, such as a wire electrode, which is corrugated as described in the above embodiments. The first ablating member 51 may also be, but is not limited to, a spot electrode, a sheet electrode, etc. The first ablating member 51 is configured to deliver the same or different ablative electrical energy as electrode 300 a. It can be understood that in the present embodiment, the first ablating member 51 is in the form of a conductive member, that is, the first ablating member 51 and the electrode 300a are disposed on the side of the covering film 102 away from the supporting skeleton 101.

In some embodiments, the first ablating member 51 is a portion of the supporting framework, such as a portion of the first framework and/or the second framework, and the first ablating member 51 is disposed at a position where the supporting framework 101 is not covered by the covering film 102. In some embodiments, the second ablating member 52 is a conductive member disposed on the support frame 101, such as disposed on the first frame and/or the second frame.

The second ablating member 52 is disposed on the occluding portion 20. Specifically, the second ablating member 52 is disposed in the ablating section 28 of the second skeleton 21. The second ablating member 52 may be the portion of the second skeleton 21 located in the ablation section 28; or may be a conductive member independent of the second frame 21. In some embodiments, the second ablating member 52 may also be disposed on the insulating section 27 and spaced apart from both the first armature 11 and the first ablating member 51.

The first ablating member, the second ablating member, and the electrode 300a are configured to deliver the same or different ablative electrical energy.

In some embodiments, the ablation occlusion device 100 is provided with only a first ablating member 51, the first ablating member 51 being arranged at the side of the cover film 102 facing away from the support skeleton 101. Specifically, the first ablating member 51 is disposed on the anchoring portion 10 and is fixed to the outer surface of the covering film 102. The first ablating member 51 is spaced apart from the electrode 300 a. For example, the first ablating member 51 is a wire electrode fixedly disposed on the outer surface of the covering film 102, and the wire electrode is corrugated as in the above embodiment. The first ablating member 51 is configured to deliver the same or different ablative electrical energy as electrode 300 a. In some embodiments, the ablation occlusion device 100 is provided with only a second ablating member 52, the second ablating member 52 being disposed in the ablation section 28 of the second skeleton 21.

The various specific embodiments in the above embodiments may be applied to each other without contradiction.

The ablation plugging system provided by the embodiment of the application has at least one of the following beneficial effects:

1. based on set up the tectorial membrane between braced skeleton and electrode to make the electrode pass through tectorial membrane and the insulating setting of braced skeleton, consequently adopt the electrode to treat the in-process that melts the tissue, the electric energy of electrode can not transmit to braced skeleton, thereby can avoid electrode and braced skeleton direct electric conduction and take place the phenomenon of short circuit, and then ensure the security, stability and the ablation effect of the electrode ablation of ablation shutoff system. In addition, the tectorial membrane can also organize thrombus in the left auricle to flow out, thereby avoid left auricle thrombus to drop the back and follow blood flow to whole body everywhere and lead to cerebral embolism (cerebral apoplexy), limb arterial embolism scheduling problem.

2. The coating can be directly formed on the anchor disc skeleton by dipping or coating to obtain a coating with relatively small porosity, thereby further enhancing the reliability and stability of the insulation between the support skeleton and the electrode.

3. The covering film is provided with a plurality of micropores for blood flow to pass through in the area except the positions of the corresponding electrodes, so that the phenomenon of short circuit caused by electric conduction between the electrodes and the supporting framework at the micropores is avoided. In addition, the micropores can limit thrombus in the left auricle to flow out of the ablation plugging device, so that the blood in the left auricle and the left atrium form normal circulation, and the problems of cerebral embolism (cerebral apoplexy), arterial embolism of limbs and the like caused by blood flowing to various parts of the whole body after the left auricle thrombus falls off are avoided.

The foregoing has outlined rather broadly the more detailed description of embodiments of the present application, wherein specific examples are provided herein to illustrate the principles and embodiments of the present application, the above examples being provided solely to assist in the understanding of the methods of the present application and the core ideas thereof; meanwhile, as those skilled in the art will have modifications in the specific embodiments and application scope in light of the ideas of the present application, the present disclosure should not be construed as being limited to the above description.

Claims

1. An ablation occlusion system, comprising:

a conveying device;

a support skeleton made of a conductive material; and

the coating film is coated outside the supporting framework; and

2. The ablation occlusion system of claim 1, wherein,

The coating film is directly formed on the supporting framework in an impregnation mode or a spraying mode; or alternatively, the process may be performed,

the coating film is fixed on the supporting framework by a dipping mode, a solution casting mode, a spraying mode, a casting mode, a compression molding mode or an injection molding mode, and the formed coating film is fixed on the supporting framework by a sewing mode, a hot pressing mode or an adhesion mode.

3. The ablation occlusion system of claim 2, wherein the porosity of said coating is less than 2.5%, and wherein the thickness of said coating is between 0.05mm and 0.3mm.

4. The ablation occlusion system of claim 1, wherein said cover film is made of an insulating material; or, the inner side surface and/or the outer side surface of the coating film are/is provided with an insulating coating.

5. The ablation occlusion system of claim 4, wherein the material of the covering film comprises an insulating material comprising at least one of polyimide, polysulfone, polyomissulfone resin, polyvinylpyrrolidone, polymethyl methacrylate, hydrogenated styrene-butadiene block copolymer, thermoplastic polyurethane elastomer, polyurethane, parylene, and silicone rubber.

6. The ablation occlusion system of claim 4, wherein the material of the covering film comprises an insulating degradable material that is a copolymer or blend of one or more polymers of polylactic acid, polycaprolactone.

7. The ablation occlusion system of claim 1, wherein the electrode is disposed on an outer side of the covering membrane facing away from the support framework.

8. The ablation occlusion system of claim 7, wherein said electrode is fixedly connected to said covering membrane and said support skeleton; or the electrode is fixedly connected with the coating film.

9. The ablation occlusion system of claim 1, wherein the delivery device comprises a movable catheter having a passageway extending axially therethrough, the movable catheter movably extending through the passageway, the movable catheter comprising a catheter body, the electrode disposed at a distal end of the catheter body, the distal end of the movable catheter being adapted for release at a distal side of the support frame.

10. The ablation occlusion system of any of claims 1-9, wherein the support skeleton comprises a bearing section, the electrode is disposed corresponding to the bearing section, and an insulating coating or sleeve is disposed on a surface of the support skeleton corresponding to the bearing section.

11. The ablation occlusion system of any of claims 1-9, wherein the ablation occlusion system comprises an ablating member disposed on the support frame for ablating tissue to be ablated, the ablating member being spaced from the electrode; the ablation piece is arranged on the outer side surface of the covering film, which faces away from the supporting framework; or the support frame is arranged at a position which is not covered by the coating film.

12. The ablation occlusion system of any of claims 1-9, wherein a plurality of anchors are provided on the support frame, the plurality of anchors being spaced circumferentially along the outer surface of the support frame, the plurality of anchors being exposed relative to the covering membrane, the plurality of anchors being staggered from the electrode.

13. The ablation occlusion system of claim 12, wherein said plurality of anchors are each disposed on a same side of said electrode.

14. The ablation and occlusion system of claim 11, wherein a plurality of anchors are disposed on the support frame and are spaced circumferentially along an outer surface of the support frame, the plurality of anchors being exposed relative to the covering membrane, the ablating member and the plurality of anchors being disposed on opposite sides of the electrode, respectively.

15. The ablation occlusion system of claim 11, wherein the ablation member is part of the support skeleton or is an electrically conductive member externally disposed on the support skeleton.

16. The ablation occlusion system of claim 11, wherein the support skeleton includes an anchor portion and an occlusion portion disposed proximal to the anchor portion, the electrode disposed at the anchor portion, the ablating member disposed at the occlusion portion.

17. The ablation occlusion system of claim 16, wherein said anchor portion is insulated from said occlusion portion.

18. The ablation occlusion system of claim 17, wherein said support skeleton includes an insulated connector, said anchor portion and said occlusion portion being connected and electrically isolated by said insulated connector.

19. The ablation occlusion system of any of claims 1-11, wherein said ablation occlusion device is a left atrial appendage ablation occlusion device, said support matrix is configured for implantation into a notch of a left atrial appendage, said cover is wrapped around a distal end of said support matrix, said cover defines a plurality of micropores for blood flow therethrough in areas other than the locations corresponding to said electrodes, and each of said micropores has a size of less than 0.25mm.