WO2023116838A1

WO2023116838A1 - Ablation device

Info

Publication number: WO2023116838A1
Application number: PCT/CN2022/141165
Authority: WO
Inventors: 陈杰; 李建民; 尤岩
Original assignee: 杭州德诺电生理医疗科技有限公司
Priority date: 2021-12-23
Filing date: 2022-12-22
Publication date: 2023-06-29
Also published as: CN113974823A; CN113974823B

Abstract

An ablation device. The ablation device comprises a support framework made of a conductive braided wire. The support framework comprises an ablation section (20) and an insulation section (10). The ablation section (20) and the insulation section (10) each comprise a plurality of support rods. The intersections of adjacent support rods comprise movable intersections. The density of the movable intersections in the insulation section (10) is a, the density of the movable intersections in the ablation section (20) is b, if b is not 0, a<b, and if b is 0, a=b=0. The area of the ablation section (20) in the support framework is reduced by performing insulating treatment on the insulation section (10), to ensure the ablation effect of the ablation device. In addition, by reducing the density of the movable intersections in the insulation section (10), the difficulty of the insulating treatment of the insulation section (10) is simplified, thereby ensuring the stability of insulation characteristics of the insulation section (10) in the support framework formed by braiding, and further ensuring the ablation effect of the ablation device.

Description

Ablation device

This application claims the priority of the Chinese patent application with application number 202111591308.4 and application title "Ablation Device" filed with the China Patent Office on December 23, 2021, the entire contents of which are incorporated herein by reference.

technical field

The invention relates to the technical field of medical devices, in particular to an ablation device.

Background technique

Atrial fibrillation (abbreviated as atrial fibrillation) is the most common sustained cardiac arrhythmia. The incidence of atrial fibrillation continues to increase with age, up to 10% of people over the age of 75.

Due to its special shape and structure, the left atrial appendage is not only the most important part of atrial fibrillation (AF) thrombus formation, but also one of the key areas for its occurrence and maintenance. The left atrial appendage occlusion device uses a special occluder to occlude the left atrial appendage, thereby achieving the purpose of preventing atrial fibrillation and thromboembolism. It is a treatment method developed in recent years with less trauma, simple operation and less time-consuming.

At present, in some technical solutions of the left atrial appendage occlusion device, a part of the support frame in the left atrial appendage occlusion device is used to generate an ablation electric field to ablate the left atrial appendage tissue. During the ablation process, if the discharge area of the supporting frame is too large, it means that the ablation impedance is too low, resulting in a low current density of the supporting frame, energy dispersion, and the ablation depth is difficult to meet the requirements.

Contents of the invention

For the existing braided ablation device structure, it is quite difficult to insulate the support frame of the ablation device. The main reason is that the supporting skeleton is formed by the interweaving of braided filaments. At the position where the braided filaments intersect, the braided filaments are not fixed to each other. Rubbing against each other produces relative motion.

There are generally two ways to insulate the surface of the braided wire, one is to put an insulating sleeve around the braided wire, and the other is to coat the surface of the braided wire with an insulating coating.

If insulation is achieved by placing an insulating coating on the surface of the braided wires, in the weaving method of the traditional braided disc, the braided wires are not fixed to each other at the intersection position, and the insulating coating is likely to be damaged in the process of mutual friction, thereby Resulting in poor insulating properties of the ablation device.

If insulation is achieved by sheathing insulating sleeves around the braided wires, since the insulating sleeves are not resistant to high temperatures, in terms of process realization, it is necessary to heat-set the semi-finished product of the braided plugging device first, and then connect the insulating sleeves. However, in the weaving method of the traditional braiding disc, the braiding wires are interlaced up and down, and the process of setting the insulating sleeve will be complicated and not easy to realize.

The technical problems to be solved by the present invention include, but are not limited to, providing an ablation device for the defect that insulation treatment of the braided ablation device is relatively difficult.

The technical solution adopted by the present invention to solve the technical problem is to provide an ablation device, which includes a support frame made of conductive braided wire, and the support frame includes an ablation section and an ablation section for electrical ablation of tissues. The insulation section, the ablation section and the insulation section both include a plurality of support rods; the density of the movable intersections formed between adjacent support rods in the insulation section is a, so The density of movable intersections formed between adjacent support rods in the ablation section is b, if b is not 0, then a<b; if b is 0, then a=b=0; wherein, Relative movement can occur between adjacent support rods at the movable intersection.

It can be seen from the above technical solutions that the embodiments of the present invention have at least the following advantages and positive effects:

In the ablation device of the embodiment of the present invention, a braided supporting frame is included, and the supporting frame includes an ablation section and an insulating section. By insulating the insulating section, the area of the ablation section in the supporting frame is reduced, and the ablation The electric energy is concentrated in the ablation section to ensure the ablation depth and ablation effect of the ablation device. At the same time, by reducing the density of movable intersections in the insulating section, the difficulty of insulating the insulating section in the supporting frame is simplified, thereby ensuring the stability of the insulating properties of the insulating section in the braided supporting frame, Thus, the ablation effect of the ablation device can be ensured.

Description of drawings

Fig. 1 is a schematic view of the end face of the supporting frame in the ablation device according to the first embodiment of the present invention.

Fig. 2 is a schematic view of the end face of the supporting frame in the ablation device according to the second embodiment of the present invention.

Fig. 3 is a schematic view of the end face of the supporting frame in the ablation device according to the third embodiment of the present invention.

Fig. 4 is a schematic view of the end face of the supporting frame in the ablation device according to the fourth embodiment of the present invention.

FIG. 5 is a schematic structural diagram of the fixed intersection in FIG. 1 .

FIG. 6 is a schematic diagram of another structure of the fixed intersection in FIG. 1 .

Fig. 7 is a schematic structural view of the left atrial appendage blockage ablation device in the fifth embodiment of the present invention.

FIG. 8 is a schematic perspective view of the three-dimensional structure of FIG. 7 .

FIG. 9 is a schematic structural diagram of the sealing disk in FIG. 8 .

FIG. 10 is a top view of FIG. 9 .

FIG. 11 is a schematic structural view of the distal disk in FIG. 10 .

FIG. 12 is an enlarged schematic view of area H in FIG. 11 .

Fig. 13 is a schematic end view of the supporting frame in the ablation device according to the sixth embodiment of the present invention.

Fig. 14 is a schematic structural view of a left atrial appendage occlusion ablation device according to Embodiment 7 of the present invention.

Fig. 15 is a schematic structural view of a left atrial appendage occlusion ablation device according to Embodiment 8 of the present invention.

Fig. 16 is a schematic structural view of a left atrial appendage occlusion ablation device according to Embodiment 9 of the present invention.

Fig. 17 is a schematic structural view of a left atrial appendage occlusion ablation device according to Embodiment 10 of the present invention.

Fig. 18 is a schematic structural view of a left atrial appendage occlusion ablation device according to an eleventh embodiment of the present invention.

Reference numerals are explained as follows: 100, sealing disc; 101, distal disc surface; 102, proximal disc surface; 200, anchor disc; 201, main rod; 202, anchor rod; 203, support rod; 210, inner support wall ; 220, outer support wall; 230, inner curved wall; 300, connector; 400, ablation electrode; 10/10A/10B/10C/10D/10E/10F, insulation section; 110, insulation unit; 11/11A/ 11B/11C/11D/11E, first support rod; 120, mesh; 20/20A/20B/20C/20D/20E/20F, ablation section; 21/21A/21B/21C/21D/21E, second Support rod; 22, the third support rod.

Detailed ways

Typical embodiments that embody the features and advantages of the present invention will be described in detail in the following description. It should be understood that the present invention is capable of various changes in different embodiments without departing from the scope of the present invention, and that the description and illustrations therein are illustrative in nature and not limiting. this invention.

In the description of the present application, it should be understood that the terms "center", "longitudinal", "transverse", "length", "width", "thickness", "upper", "lower", "front", " Orientation indicated by rear, left, right, vertical, horizontal, top, bottom, inside, outside, clockwise, counterclockwise, etc. The positional relationship is based on the orientation or positional relationship shown in the drawings, which is only for the convenience of describing the application and simplifying the description, and does not indicate or imply that the referred device or element must have a specific orientation, be constructed and operated in a specific orientation, Therefore, it should not be construed as limiting the application.

In addition, the terms "first" and "second" are used for descriptive purposes only, and cannot be interpreted as indicating or implying relative importance or implicitly specifying the quantity of indicated technical features. Thus, a feature defined as "first" or "second" may explicitly or implicitly include one or more of said features. In the description of the present application, "plurality" means two or more, unless otherwise specifically defined.

In the description of this application, it should be noted that unless otherwise specified and limited, the terms "installation", "connection", and "connection" should be understood in a broad sense, for example, it can be a fixed connection or a detachable connection. Connected, or integrally connected; it can be mechanically connected or electrically connected; it can be directly connected or indirectly connected through an intermediary, and it can be the internal communication of two components. Those of ordinary skill in the art can understand the specific meanings of the above terms in this application in specific situations.

Definition Interpretation:

Left atrial appendage mouth: the connection between the left atrium and the left atrial appendage.

Proximal end and distal end: In the field of interventional medical device technology, the end close to the operator is generally called the "proximal end" of the ablation device, and the end far away from the operator is called the "distal end" of the ablation device, and based on this principle Defines the "proximal" and "distal" ends of any component in the ablation device.

Insulation treatment: Forming an insulating layer on the surface of a component to insulate that part of the component. Specifically, the insulation treatment methods include: coating or impregnating insulation coating materials at the position where insulation treatment is required. Coating materials include but are not limited to parylene, PTFE (Poly-tetra-fluoroethylene, polytetrafluoroethylene), PI (Polyimide, polyimide); or, put an insulating sleeve on the position that needs to be insulated. The material of the insulating sleeve includes but is not limited to FEP, PU, ETFE, PFA, PTFE, PEEK, and silica gel. In some implementation manners, the above-mentioned multiple insulation treatment solutions may be performed on the part requiring insulation treatment.

The ablation device provided by the embodiment of the present invention is a left atrial appendage occlusion ablation device, which is used to be implanted in the mouth of the left atrial appendage, and can perform electrical ablation on the left atrial appendage tissue. The ablation device uses percutaneous puncture to deliver it to the target ablation area through the delivery device (sheath), and ablates the target ablation area through pulse ablation, radio frequency ablation, microwave ablation or other forms of electric energy to achieve electrical isolation. Effect. It can be understood that the ablation device provided by the embodiment of the present invention can also be an ablation catheter without occlusion, such as ablation catheters used in fields such as left atrial appendage ablation, pulmonary vein ablation, myocardial tissue ablation, and renal artery ablation.

Among them, pulse ablation uses a high-intensity pulse electric field to cause irreversible electrical breakdown of the cell membrane, which is called irreversible electroporation (IRE) in the medical field, and causes cell apoptosis to achieve non-thermal ablation of cells. Compared with other energies, pulse ablation does not require heat conduction to ablate deep tissue, and all cardiomyocytes distributed above a certain electric field strength will undergo electroporation, which reduces the requirement for catheter abutment pressure during ablation. Therefore, even if the ablation instrument does not completely adhere to the inner wall of the left atrial appendage after entering the left atrial appendage, the ablation effect of the IRE will not be affected.

Electrodes (ablation components) that release electrical energy for ablation, such as electrodes that release at least one form of energy such as pulse energy, radiofrequency energy, and microwave energy, can also collect intracardiac electrical signals. Before ablation, collect intracardiac electrical signals for transmission To the ECG synchronization instrument, the pulse output is synchronized in the absolute refractory period of myocardial contraction, so as not to interfere with the heart rate and reduce sudden arrhythmia; after the ablation operation, the intracardiac signal can also be used to judge whether the tissue is completely electrically isolated.

Embodiment 1, refer to the structure shown in FIG. 1 .

Fig. 1 is a schematic view of the end face of the supporting frame in the ablation device according to the first embodiment of the present invention. Figure 1 shows a schematic diagram of the proximal surface of the support frame in the left atrial appendage occlusion ablation device. The left atrial appendage occluder is used to block the opening of the left atrial appendage. Figure 1 shows the view from the left atrium to the interior of the left atrial appendage. Structural diagram of part of the supporting skeleton. The support frame shown in Figure 1 can be a schematic diagram of the proximal or distal surface of the sealing disc in the left atrial appendage occlusion ablation device shown in Figure 7, or it can be the anchor disc in the left atrial appendage occlusion device shown in Figure 7 Schematic diagram of the proximal or distal surface of the . It can be understood that the left atrial appendage occlusion ablation device can also be provided with a membrane body for blocking flow on the support frame as required.

Please refer to FIG. 1 , the ablation device provided by the embodiment of the present invention includes a support frame, which is an expandable and contractible frame structure. The center of the supporting frame has an axis extending from the proximal end to the distal end, and the supporting frame can expand and expand radially outward, or compress and contract radially inward with the axis as the axis.

It should be noted that, in this embodiment, the support frame can be a single-disc structure, a double-disk structure, or a multi-disc structure. The structure shown in the figure is a view from the proximal end to the distal end. Schematic diagram of the disc structure.

Part or all of the supporting frame is made of conductive braided wire, so that the supporting frame as a whole has electrical conductivity, and the supporting frame is made of one material as a whole, which is convenient for manufacturing. The material of the braided wire can be a superelastic metal with better biocompatibility, such as stainless steel, nickel-titanium alloy or cobalt-chromium alloy.

The support frame formed by weaving includes an ablation section 20 for electrical ablation of the target tissue to be ablated and an insulating section 10 other than the ablation section 20 .

Both the ablation section 20 and the insulation section 10 include a plurality of support rods. The support rod is made of conductive filamentary braided wires, or is formed by braiding a plurality of conductive braided wires. It should be noted that the support rod may be composed of a single braided wire, and the support rod may also be a linear or bundle structure formed by twisting or other braiding methods of multiple braided wires. A plurality of support rods are mutually braided to form the ablation section 20 and the insulation section 10 respectively.

In the plurality of braided support rods, there is no intersection point between some adjacent support rods, that is, there is no contact connection point. There are also intersections between some adjacent support rods, that is, there are connection points that are in contact. In these intersections, at some intersections, the positions between the corresponding support rods are relatively fixed, and the corresponding support rods cannot move relative to each other at the intersection, which is defined as a fixed intersection; at some intersections , relative movement can occur between corresponding support rods, and this intersection is defined as a movable intersection, that is, relative movement can occur between adjacent support rods at the movable intersection.

During the expansion or contraction of the support frame, since the positions of the support rods at the movable intersections can move relatively, the support rods rub against each other at the movable intersections, resulting in relative motion.

It should be noted that the relative movement generally occurs during the expansion or contraction deformation process of the supporting frame, such as the loading process of ablation device accommodated in the sheath, and the release process of the ablation device in the ablation target area. In some usage environments, when the ablation device performs ablation in the target area, some deformations of the supporting frame may occur, resulting in expansion or contraction of the supporting frame.

At least part of the support rods of the ablation section 20 are conductive rods, the surface of the conductive rods is conductive, and then can discharge through the conductive rods to generate an ablation electric field, and then make the ablation section 20 perform pulse ablation or radio frequency ablation, and the ablation section 20 serves as a support The ablation component on the frame is used for ablation of left atrial appendage tissue.

At least part of the supporting rods of the insulating section 10 are insulating rods, each insulating rod is formed by the above-mentioned conductive braided wire, and the surface of the insulating rods is insulated, so that the surface of the insulating rods is insulated, and then a part of the supporting frame is set The surface of the skeleton is not used for ablation, so it is convenient to set the ablation section 20 in the position suitable for ablation in the support skeleton, reduce the proportion of the ablation section 20 in the support skeleton, and concentrate the ablation energy around the ablation section 20, so as to increase the ablation depth and improve ablation effect. Specifically, an insulating sleeve can be placed on the surface of the insulating rod, and/or an insulating coating can be provided on the surface of the insulating rod, thereby achieving surface insulation.

Please refer to FIG. 1 , the supporting frame includes an abutment wall for contacting with left atrial appendage tissue and a support wall in contact with the abutment wall. The support wall is not intended to be in contact with LAA tissue. The abutment wall is disposed on the peripheral edge of the ablation device.

Wherein, the ablation section 20 is set at the abutting wall of the supporting frame, which can adopt a ring structure, such as being arranged in the peripheral edge frame area of the supporting frame, so as to realize ring-shaped ablation of the ostium of the left atrial appendage, or ablation of the left atrial appendage. The inner wall tissue of the atrial appendage is ablated circularly.

The insulating section 10 is disposed at least on the supporting wall, such as in the area of one end surface or two end surfaces of the supporting frame. The insulating section 10 at the supporting wall is closer to the axis than the ablation section 20, and is not used for contacting the left atrial appendage tissue, so the ablation for tissue ablation is not good. In addition, setting the insulating section 10 at the support wall that is not in contact with the left atrial appendage tissue can reduce the area ratio of the ablation section 20, concentrate the ablation energy around the ablation section 20, and increase the ablation depth and improve the ablation effect.

In some embodiments, the insulating section 10 can also be arranged at the abutting wall, the insulating section 10 can be arranged in the ablation section 20, and be arranged in the ablation section 20 at intervals or in sections, thereby further reducing ablation The area ratio of the section 20 improves the ablation effect. And it can further realize functions such as point ablation, line ablation or regional ablation of left atrial appendage tissue. Still referring to FIG. 1 , the insulating section 10 includes a plurality of supporting rods, the supporting rods in the insulating section 10 are defined as first supporting rods 11, at least part of the plurality of first supporting rods 11 are insulating rods, and the insulating rods are The surface of the support rod is non-conductive and not used to transmit ablation electric energy to the tissue, that is, at least part of the surface of the first support rod 11 is insulated, so that at least part of the surface of the first support rod 11 is insulated, thereby forming an insulating rod. In this embodiment, all the first support rods 11 are insulating rods. A plurality of first support rods 11 are arranged at intervals in the circumferential direction, and radially arranged from the center of the end surface or the disk surface of the support frame, as shown in the end view of FIG. 1 . It can be understood that the first support rods 11 can also be arranged radially from the center along an arc to the surroundings. It should be noted that the shape and number of the first support rods 11 in the insulating section 10 can be adjusted according to the area of the disk surface or the end surface, or according to other needs, which is not limited here.

In the insulation section 10 , a plurality of first support rods 11 are formed with a plurality of insulation units 110 , and each insulation unit 110 includes at least one first support rod 11 extending in bundles. In this embodiment, each insulation unit 110 includes a first support rod 11 , and each first support rod 11 serves as an insulation unit 110 . The periphery of each insulating unit 110 is covered with an insulating sleeve, and/or the surface of the periphery of each insulating unit 110 is coated with an insulating coating, and/or the surface of each support rod in each insulating unit 110 is coated with an insulating coating, In order to realize the surface insulation of each insulating unit 110 .

There is no movable cross point among the plurality of first support rods 11 (insulation units) in the insulation section 10, so it is beneficial to carry out insulation treatment on each first support rod 11, that is, each first support rod 11 is provided with an insulating coating and/or is fitted with an insulating sleeve, which is beneficial to the realization of the insulation process, and is convenient to reduce the difficulty of the process, thereby reducing the production cost.

The near end or the far end of the insulating section 10 forms a converging end for converging the first support rod 11 , and the insulating section 10 is radially arranged from the converging end to the circumferential edge. Specifically, the end surface of the insulating section 10 or the converging end of the disk surface is provided with a connecting piece 300, which is used for connecting with other disks supporting the frame or connecting with the delivery device. One ends of the plurality of first support rods 11 are all connected to the connecting piece 300 , and are distributed radially around by the connecting piece 300 , and the connecting piece 300 at the center can be used to tighten the plurality of first support rods 11 in a circle around. After the multiple first support rods 11 are heat-set, an insulating sleeve can be sheathed on the periphery of each first support rod 11, and then the connector 300 can be installed to complete the production; or after the multiple first support rods 11 are heat-set, first The connecting piece 300 is fitted, and an insulating coating is provided.

The proximal end or the distal end of the insulating section 10 forms a converging end for converging the first support rods 11, so that after the first support rods 11 are heat-set, without assembling the connector 300, multiple first support rods 11 can be connected. At least one end (proximal end or distal end) of the rod 11 is a free end, which is convenient for threading an insulating sleeve to the first support rod 11 from the position of the free end of the first support rod 11 . When the connecting piece 300 is provided in the central area of the insulating section 10, the multiple first support rods 11 are connected to the connecting piece 300 as a fixed connection, and the multiple first supporting rods 11 cannot move relative to each other at the position of the connecting piece 300. Therefore, the position of the connecting member 300 is also a fixed intersection point of the plurality of first support rods 11 .

If the converging end for converging the first support rod 11 is not set in the insulating section 10, then the insulating sleeve is threaded to the first support rod 11, and the insulating sleeve needs to be threaded from other areas, such as The converging end is formed in the ablation section 20, and the insulating sleeve needs to be put on the end of the support rod of the ablation section 20 until the insulating sleeve is accurately positioned to the periphery of the first support rod 11 without affecting the ablation The support rod surfaces in section 20 are discharged.

It should be noted that when the connecting member 300 is not provided in the central area of the insulating section 10 as shown in FIG. A fixed intersection is formed at the center.

Still referring to FIG. 1 , the ablation section 20 includes a plurality of support rods. In this embodiment, the plurality of support rods include a plurality of second support rods 21 arranged at intervals in the circumferential direction and a plurality of second support rods 21 arranged in a circumferential circle. Three support rods 22.

A plurality of second support rods 21 are circumferentially spaced around the insulating section 10 . It should be noted that, the second support rod 21 may be formed by extending the first support rod 11 , that is, the second support rod 21 and the first support rod 11 are integrally structured. The second support rod 21 may also be fixedly connected to the distal end of the first support rod 11 away from the center, thereby forming a fixed cross point between the first support rod 11 and the second support rod 21 .

A plurality of third support rods 22 is arranged in a circle around the plurality of second support rods 21, so as to connect the plurality of second support rods 21 in a circumferential direction through the plurality of third support rods 22, thereby improving the ablation section The support performance of the disk surface and the supporting frame of 20 prevents the overall transitional deformation and displacement of the disk surface or the supporting frame, increases the contact area between the ablation section 20 and the tissue, and forms a closed-loop ablation zone in the left atrial appendage tissue, avoiding the gap between the second support rod 21 If the distance between them is too far, the ablation zone formed on the tissue by the adjacent second support rods 21 will be discontinuous, and the problem of insufficient ablation depth will arise.

As shown in Figure 1, one end of the third support rod 22 can be fixedly connected to a second support rod 21, and the other end of the third support rod 22 is fixedly connected to another adjacent second support rod 21, that is, the third support rod 22 It is connected between two adjacent second support rods 21 . The connection point between the third support rod 22 and the second support rod 21 is a fixed cross point.

In some embodiments, the plurality of third support rods 22 is an integral ring structure.

As shown in Figure 1, a plurality of third support rods 22 are connected to each other in a zigzag shape, and the distances between the two ends of each third support rod 22 are different from the connector 300, and one end of each third support rod 22 is connected to the first The ends of the two support rods 21, the other end of each third support rod 22 is connected to the position where the opposite end of the other second support rod 21 is closer to the connector 300, and the adjacent two third support rods 22 are connected to each other. At the same position of the same second support rod 21 , the third support rod 22 is connected to each other in a zigzag shape, which can flexibly contract and expand in the radial direction, so as to facilitate the loading and release of the ablation device.

Specifically, the third support rod 22 can be connected to multiple second support rods 21 by bonding, weaving, welding, sewing, etc.; at this time, the connection point between the third support rod 22 and the second support rod 21 is Fixed intersection. The third support rod 22 of the annular structure can also be passed through a plurality of second support rods 21. For example, when the second support rod 21 adopts a plurality of braided wires arranged side by side in bundles, gaps are formed between the braided wires. The three supporting rods 22 can pass through the gap for relative fixing.

It should be noted that, in the ablation section 20 , the ring structure formed by the plurality of third support rods 22 can be arranged in multiple turns, and arranged at intervals or intersecting along the extending direction of the second support rods 21 .

It can be understood that, among the multiple second support rods 21 and the multiple third support rods 22 of the ablation section 20, at least part or all of the second support rods 21 and the third support rods 22 are conductive rods, so as to facilitate The ablation energy is delivered to the target tissue for tissue ablation.

In some embodiments, the ablation section 20 may be annularly disposed on the circumferential edge of the insulating section 10 , such as a circle corresponding to the ostium of the left atrial appendage, so as to ablate the inner wall tissue of the ostium of the left atrial appendage. The annular shape of the ablation section 20 can improve the sealing performance of the disc surface supporting the skeleton at the tissue mouth.

In some embodiments, a choke film can also be provided on the disk supporting the skeleton, for example, in a double-layer disk structure, the choke film can be arranged in the inner cavity of the disk; in a single-layer disk structure, the choke film can be provided on the proximal and/or distal sides of the disk.

Referring to FIG. 1 , the number of movable intersections per unit area in the insulating section 10 is defined as a, that is, the density of movable intersections in the insulating section 10 is a. The number of movable intersections per unit area in the ablation section 20 is defined as b, that is, the density of movable intersections in the ablation section 20 is b.

In the embodiment shown in Fig. 1, since there is no movable intersection in the insulating section 10, that is, the number of movable intersections per unit area is 0, that is, a is 0, which is convenient for supporting in the insulating section 10. Insulation treatment is carried out on the surface of the skeleton, for example, in the scheme of surface insulation using an insulating coating, it can effectively avoid the relative movement of the support rods in the insulating section 10 at the position of the movable intersection, resulting in the possibility of damage to the insulating coating , and then improve the insulating properties of the insulating section 10 and the entire ablation device; in the scheme of adopting the surface insulation of the insulating sleeve, the insulating sleeve does not need to be inserted up and down on the insulating section 10 formed by the braided wire The operation is convenient for the installation of the insulating sleeve, and the process is simple.

In this embodiment, since there is no movable intersection in the ablation section 20 , that is, the number of movable intersections per unit area is 0, that is, a=b=0.

In some embodiments, the density and number a of movable intersections per unit area in the insulating section 10 may not be 0, that is, there are certain density and number of movable intersections. However, a<b is satisfied, that is, the density of movable intersections per unit area of the insulating section 10 is relatively low. If the insulating coating solution is adopted, the movable intersections are relatively sparse, thereby reducing the probability of damage to the insulating coating due to relative movement at the movable intersections, and improving the insulation performance of the insulating section 10 and the entire ablation device. If the insulating sleeve scheme is adopted, since the movable intersection points are relatively sparsely distributed in the insulating section 10, during the process of insulating the sleeve fitting, the insulating sleeve is inserted up and down on the insulating section 10 formed by the braided wire. The number of times is less, the process is less difficult, and it is convenient for the set of the insulating sleeve.

Still referring to Fig. 1, it can be understood that since the density of the movable intersections in the insulating section 10 is 0, that is, a=0, on a unit area, the number of movable intersections in the insulating section 10 The number of movable intersections in the ablation section 20 is smaller than that, thereby reducing the probability of damage to the insulating coating due to friction at the movable intersections, or facilitating the fitting of the insulating sleeve. The density b of the movable intersections in the ablation section 20 may or may not be zero.

In this embodiment, neither the insulating section 10 nor the ablation section 20 has a movable intersection point, that is, a=b=0. Neither the intersection point in the insulating section 10 nor the ablation section 20 can move, so this structural solution can reduce the damage probability of the insulating coating due to friction, or facilitate the fitting of the insulating sleeve.

In some embodiments, the distribution of movable intersections in the insulating section 10 is sparser than that in the ablation section 20 , that is, when b is not 0, a<b. In a preferred embodiment, a=0, ie there is no movable intersection of the insulating section 10 . This structural solution can reduce the damage probability of the insulating coating due to friction, or facilitate the fitting of the insulating sleeve.

Embodiment 2, refer to the structure shown in FIG. 2 .

Please refer to FIG. 2 , the structure of the supporting frame of the ablation device of the embodiment of the present invention is similar to that of the ablation device of the embodiment of FIG. 1 , and the supporting frame includes an insulating section 10A and an ablation section 20A. The main difference between the supporting framework of this embodiment and the supporting framework of the embodiment in FIG. 1 lies in the specific structural shapes of the insulating section 10A and the ablation section 20A.

In this embodiment, the end surface of the insulating section 10A is provided with a connecting piece 300 , preferably, the connecting piece 300 is located at the center of the disk surface formed by the supporting frame. Connector 300 is used to connect to other discs of the supporting frame or to connect delivery devices. The insulation section 10A includes a plurality of first support rods 11A arranged at circumferential intervals around the peripheral side of the connector 300 , and the first support rods 11A are arranged radially from the center to the periphery in an arc shape, as shown in the end view of FIG. 2 . It can be understood that, in this embodiment, the first support rod 11A can also adopt a linear structure, which is radially arranged from the center of the end surface or the disk surface to the surroundings, that is, as shown in the end view of Figure 1, that is, the first A support rod 11A is also not limited here.

The ablation section 20A includes a ring-shaped second support rod 21A. The second support rod 21A is arranged at the peripheral position of the insulating section 10A, and transmits ablation energy to the target tissue through the second support rod 21A for tissue ablation.

Referring to FIG. 2 , one end near the center of the first support rod 11A is fixedly connected to the connecting member 300 , and one end of the first support rod 11A toward the periphery is fixedly connected to the second support rod 21A. Therefore, the density a of the movable intersections in the insulation section 10A is 0, and there is no movable intersections, so the surface of the first support rod 11A can be relatively easily insulated. At the same time, because the second support rod 21A is a ring structure, and because the first support rod 11A and the second support rod 21A are fixedly connected, the density b of the movable intersection point of the ablation section 20A is 0, that is, There is no movable intersection point, so the intersection points of the entire supporting frame will not rub against each other, which is beneficial to improving the insulation performance of the insulating section 10A and the entire ablation device, thereby ensuring the ablation effect of the ablation device.

In some embodiments, the ablation section 20A is formed by combining a plurality of second support rods 21A in bundles, and each second support rod 21A may be in the form of a ring or a partial ring, that is, the central angle occupied by each second support rod 21A It can be 360 degrees or any other angle.

In some embodiments, the first support rod 11A and the second support rod 21A are integrally constructed, that is, the first support rod 11A and the second support rod 21A are the same braided wire, or the same strand (multiple) braided wires along the arc The different sections extending from the shape track, the section close to the connecting piece 300 is the first support rod 11A, and the section away from the connecting piece 300 is the second supporting rod 21A. Each second support rod 21A extends in the circumferential direction and occupies a certain circumferential angle, such as 15 degrees or 30 degrees, that is, each second support rod 21A does not make a circle around the support frame. In the ablation section 20A, adjacent second support rods 21A are fixedly connected to each other, for example, adjacent second support rods 21A are fixedly connected end-to-end in sequence, and a plurality of second support rods 21A are ring-shaped. The plurality of ring-shaped second support rods 21A are used to ablate tissue, for example, ablate tissue around the mouth of the left atrial appendage.

Embodiment 3, refer to the structure shown in FIG. 3 .

Please refer to FIG. 3 , the structure of the supporting frame of the ablation device of the embodiment of the present invention is similar to that of the ablation device of the embodiment of FIG. 2 , and the supporting frame includes an insulating section 10B and an ablation section 20B. The main difference between the support framework of this embodiment and the support framework of the embodiment in FIG. 2 lies in the specific structural shape of the ablation section 20B and the number of movable intersections of the ablation section 20B.

In this embodiment, the end surface of the insulating section 10B is provided with a connecting piece 300, which is used for connecting with other disks supporting the frame or connecting with a delivery device. The insulating section 10B includes a plurality of first support rods 11B arranged at circumferential intervals around the peripheral side of the connector 300 , and the first support rods 11B are arranged radially from the center to the periphery in an arc shape, as shown in the end view of FIG. 2 . It can be understood that, in this embodiment, the first support rods 11B can also be linear, wavy or other shapes, arranged radially from the center of the end surface or disk surface to the surroundings, that is, as shown in the end view of Figure 1 As shown, that is, the first support rod 11B is not limited here.

The ablation section 20B adopts a network structure formed by weaving a plurality of support rods through a dense mesh, and the ablation section 20B is arranged around the periphery of the insulating section 10B. The ablation section 20B includes a plurality of second support rods 21B arranged around the circumference of the insulating section 10B. Two second support rods 21B are connected to the end near the periphery of the first support rod 11B, and the two second support rods 21B extend along different directions and can be woven with adjacent second support rods 21B , and then form a densely woven mesh structure.

It should be noted that the number of the second support rods 21B connected to the first support rods 11B can be three or more, which can be adjusted according to needs, and then the density of the braided wires of the ablation section 20B can be changed, which is beneficial to Enlarging the radial dimension occupied by the ablation section 20B facilitates the ablation section 20B to adhere to the wall.

Please refer to FIG. 3 , in this embodiment, there is no movable intersection point in the insulating section 10B, and the density a of the movable intersection point is zero. The second support rods 21B of the ablation section 20B are braided with each other and form a movable intersection at the intersection. At the movable intersection 209, the corresponding two second support rods 21B braided with each other may be overlapped. relationships, or specific structures that are interwoven and can move relative to each other. The density b of the movable intersections 209 in the ablation section 20B is not 0, a<b, which can reduce the damage probability of the insulating coating in the insulating section 10B due to friction, or help simplify the process difficulty and facilitate the installation of the insulating sleeve. In this embodiment, there is no movable intersection point in the insulating section 10. In other embodiments, there may be a movable intersection point in the insulating section 10, and a<b is satisfied, and the insulation difficulty of the insulating section 10 can also be simplified. , improve the insulation performance of the ablation device.

It should be noted that when the second support rods 21B of the ablation section 20B are braided with each other, the movable cross point 209 can also be changed into a fixed cross point by means of bonding, splicing, knotting, welding, sewing, etc., and then Let b be 0, at this time a=b=0, the relative movement range between the adjacent second support rods 21B in the ablation section 20B is reduced, and the adjacent first support rods 11B in the insulation section 10B are The second support rods 21B are pulled and driven to reduce the probability of mutual friction. This structural solution can further reduce the probability of damage to the insulating coating in the insulating section 10B due to friction, or is more conducive to the installation of the insulating sleeve.

It should also be noted that the insulating section 10B may also have a small number or sporadic movable intersections. At this time, the density a of the movable intersections is not 0, a<b, and the movable intersections in the insulating section 10B are relatively Sparseness can also reduce the damage probability of the insulating coating in the insulating section 10B due to friction, or help to simplify the difficulty of the process and facilitate the installation of the insulating sleeve.

Embodiment 4, refer to the structure shown in FIG. 4 .

Please refer to FIG. 4 , the structure of the supporting frame of the ablation device of the embodiment of the present invention is similar to that of the ablation device of the embodiment of FIG. 3 , and the supporting frame includes an insulating section 10C and an ablation section 20C. The main difference between the supporting framework of this embodiment and the supporting framework of the embodiment in FIG. 3 lies in the specific structural shapes of the insulating section 10C and the ablation section 20C.

In this embodiment, the end surface of the insulating section 10C is provided with a connector 300, and the insulating section 10C includes a plurality of first support rods 11C arranged at circumferential intervals around the peripheral side of the connector 300, and the first support rods 11C are in a straight line. type, and radially arranged from the center to the surroundings, as shown in the end view of Figure 4. It can be understood that, in this embodiment, the first support rod 11C can also adopt an arc shape or other shapes, and be arranged radially from the center of the end surface or the disk surface to the surroundings, that is, as shown in the end view of Figure 3, that is, the first A support rod 11C is also not limited here.

The ablation section 20C adopts a network structure formed by weaving a plurality of support rods through a dense mesh, and the ablation section 20C is arranged around the periphery of the insulating section 10C. The ablation section 20C includes a plurality of second support rods 21C arranged around the circumference of the insulating section 10C.

Please refer to FIG. 4 , a second support rod 21C is connected to the end of each first support rod 11C near the periphery, and a second support rod 21C connected to the first support rod 11C may be a different support rod. The section, that is, the two are integrated structures. In a modified embodiment, the first support rod 11C and a second support rod 21C connected to it are different support rods and are connected together through a fixing process. The second support rod 21C can be woven with the adjacent second support rod 21C to form a densely woven mesh structure.

In some embodiments, the multiple second support rods 21C are divided into two groups, and the second support rods 21C in the two groups correspond to each other and are arranged adjacently at intervals. One group of second support rods 21C extends obliquely to the periphery of the support frame in the clockwise direction, and the other group of second support rods 21C extends obliquely to the periphery of the support frame in the counterclockwise direction, so that the two groups of second support rods 21C mutually Weaving forms a densely woven mesh structure.

Please refer to FIG. 4 , in this embodiment, there is no movable intersection point in the insulating section 10C, and the density a of the movable intersection point is zero. The second support rods 21C of the ablation section 20C are braided with each other and form a movable intersection at the intersection. For example, at the movable intersection, the corresponding two second support rods 21B braided with each other may be overlapped. relationships, or specific structures that are interwoven and can move relative to each other. The ablation section 20C formed by dense mesh weaving can flexibly realize expansion and contraction in the radial direction, which facilitates the loading and release of the ablation device. The density b of the movable intersection points in the ablation section 20C is not 0, a<b, The movable intersections in the insulating section 10 are relatively sparse, and this structural solution can reduce the damage probability of the insulating coating in the insulating section 10C due to friction, or help simplify the difficulty of the process and facilitate the installation of the insulating sleeve.

It should be noted that when the second support rods 21C of the ablation section 20C are woven together, the movable intersections can also be changed into fixed intersections by means of bonding, splicing, knotting, welding, sewing, etc., so that b is 0, at this time a=b=0, this structural solution can reduce the damage probability of the insulating coating in the insulating section 10C due to friction, or is more conducive to the installation of the insulating sleeve.

It should also be noted that the insulating section 10C may also have a small number or sporadic movable intersections. At this time, the density a of the movable intersections is not 0, a<b, and the movable intersections in the insulating section 10C are relatively Sparseness can also reduce the damage probability of the insulating coating in the insulating section 10C due to friction, or help to simplify the difficulty of the process and facilitate the installation of the insulating sleeve.

FIG. 5 is a schematic structural diagram of the fixed intersection in FIG. 1 . FIG. 6 is a schematic diagram of another structure of the fixed intersection in FIG. 1 .

Referring to FIGS. 5 and 6 , in some embodiments, at fixed intersections 108 between struts in the insulating section or ablation section, that is, at the joints between struts that are densely woven, a The way of bonding makes the positions of the joints between the support rods relatively fixed, as shown in FIG. 5 . Splicing or knotting can also be used to make the position of the connection between the support rods relatively fixed, that is, two adjacent support rods are twisted and twisted at the connection, and after being woven and fixed as one, they are separated and extended in different directions. , and then perform twisted weaving with another support rod, and finally weave to form a network structure of dense mesh weaving, as shown in FIG. 6 . In addition, relative fixing can also be carried out by means of welding, sewing or setting additional fixing parts, so as to realize the fixed cross point 108 between the support rods. The methods of bonding, splicing, knotting, welding, sewing and the like mentioned above are all applicable to the insulation treatment scheme of the insulating coating.

It should be noted that, among the various fixing methods mentioned above, only one of them may be selected for relative position fixing, or a combination of two or more methods may be selected for relative position fixing.

Embodiment 5, refer to the structures shown in FIG. 7 to FIG. 12 .

Fig. 7 is a schematic structural view of the left atrial appendage blockage ablation device in the fifth embodiment of the present invention. FIG. 8 is a schematic perspective view of the three-dimensional structure of FIG. 7 . FIG. 9 is a schematic structural diagram of the sealing disk 100 in FIG. 8 . FIG. 10 is a top view of FIG. 9 .

Please refer to FIG. 7 to FIG. 10 , the ablation device provided in this embodiment includes a support frame, and the support frame adopts a double disc structure. The support frame includes a sealing disc 100 at its proximal end for blocking the opening of the left atrial appendage and an anchoring disc 200 at its distal end for anchoring to the inner wall of the left atrial appendage.

In this embodiment, both the sealing disc 100 and the anchoring disc 200 are radially expandable and contractible skeleton structures. Both the sealing disc 100 and the anchoring disc 200 may be made of superelastic metal material. The sealing disk 100 is made of conductive braided wire, and the anchor disk 200 is made of pipe cutting. It can be understood that, in some other embodiments, the anchoring plate 200 can also be made by braiding filamentary materials. In some embodiments, the anchoring disk 200 is made of metal or non-metal material, and can be made into a hollow grid shape by weaving or cutting process, or can be in the form of a balloon.

The sealing disc 100 and the anchoring disc 200 are connected through a connecting piece 300 . The connecting piece 300 is arranged at the axis of the anchoring disk 200 and at the axis of the distal end of the sealing disk 100 .

In some embodiments, at least part of the connector 300 can be made of insulating material or partially insulating material, so that an insulating connection is formed between the sealing disc 100 and the anchoring disc 200, that is, the sealing disc 100 and the anchoring disc 200 electrical isolation between them.

Referring to FIG. 7 to FIG. 10 , the skeletons of the sealing disc 100 and the anchoring disc 200 both include an abutment wall in contact with the left atrial appendage tissue and a support wall in contact with the abutment wall. The support wall is a region in the support frame that is not used to contact the left atrial appendage tissue, and the support wall can support the abutment wall to keep the abutment wall in contact with the left atrial appendage tissue.

Wherein, the ablation section 20D is set on the abutting wall, not only can be set on the abutting wall of the sealing disc 100, but also can be set on the abutting wall of the anchoring disc 200, and then through the ablation section 20D and the left atrial appendage The tissue contacts and transmits ablation energy, thereby achieving tissue ablation.

The insulating section 10D is set on the supporting wall, not only can be set on the supporting wall of the sealing plate 100, but also can be set on the supporting wall of the anchoring plate 200, the insulating section 10D is set on the supporting wall, which can improve the ablation section 20D Impedance increases the current density of the ablation section 20D to concentrate the energy, which is beneficial to increase the ablation depth of the target tissue and effectively guarantees the ablation effect of the sealing disc 100 and the ablation device.

It should be noted that the insulating section 10D can also be arranged on the abutment wall to further reduce the area of the ablation section 20D on the abutment wall, so as to further increase the current density of the ablation section 20D and make the energy more concentrated.

After the ablation device is released to the left atrial appendage, the ablation section 20D is closer to the tissue than the insulation section 10D. In particular, in this embodiment, the sealing disk 100 is provided with the ablation section 20D and the insulation section 10D. At least two ablation components for electrical ablation of tissue are provided on the supporting frame, one of which is formed by the ablation segment 20D on the sealing disk 100, the ablation segment 20D is used to block the ostium of the left atrial appendage, and the left atrial appendage The mouth is located at the junction of the left atrial appendage and the left atrium. The surface of the mouth tissue of the left atrial appendage is flat and regular in shape. The ablation section 20D set on the sealing disk 100 can be relatively accurately attached to the mouth tissue of the left atrial appendage, which facilitates the concentration of ablation energy. In the ablation section 20D where the ablation effect is likely to be produced on the tissue.

Please refer to FIG. 9 and FIG. 10 , the sealing disc 100 includes a plurality of support rods, and the support rods are made of conductive filamentary braided wires, or formed by weaving a plurality of conductive braided wires.

Please refer to FIG. 7 to FIG. 10 , a plurality of support rods are interwoven to form a double-layer sealing disc 100 . Specifically, the sealing disk 100 includes a proximal disk surface 102, a distal disk surface 101, and a waist 103. The proximal disk surface 102 is arranged on the proximal side of the distal disk surface 101. The proximal disk surface 102 and the distal disk surface 101 are approximately planar. The waist 103 It is connected between the proximal disk surface 102 and the distal disk surface 101 , and is connected to the circumferential edges of the proximal disk surface 102 and the distal disk surface 101 . As shown in FIG. 7 , the disk surface of the sealing disk 100 close to the anchor disk 200 is the distal disk surface 101, and the disk surface of the sealing disk 100 away from the anchor disk 200 is the proximal disk surface 102, and the proximal disk surface 102 is used for connecting delivery device. The projection of the sealing disc 100 on a plane passing through the axial direction is roughly trapezoidal, and the waist 103 is disposed on the peripheral edge of the sealing disc 100 , and the radial dimension gradually increases from the far side to the near side. After the left atrial appendage occlusion and ablation device is implanted in the living body, the sealing disc 100 is used to block the mouth of the left atrial appendage, the anchoring disc 200 is used to anchor inside the left atrial appendage, and the waist 103 is used to abut against the tissue of the mouth of the left atrial appendage. The abutment wall 106 , the proximal disk surface 102 and the distal disk surface 101 are used to provide support, and are not used to abut against the tissue wall, which is the support wall 105 . After the ablation device is released to the left atrial appendage, the circumferential edges of the proximal disk surface 102 and the distal disk surface 101 are used to abut against the tissue wall of the mouth of the left atrial appendage.

FIG. 11 is a schematic structural diagram of the distal disc surface 101 in FIG. 10 . FIG. 12 is an enlarged schematic view of area H in FIG. 11 .

Please refer to FIG. 11 and FIG. 12 , a plurality of support rods are interwoven to form an ablation section 20D and an insulating section 10D respectively.

Specifically, the insulating section 10D is arranged on the support wall of the distal disk surface 101 of the sealing disk 100, and radiates from the center of the distal disk surface 101 of the sealing disk 100 to the surroundings in the radial direction, that is, the insulating section 10D is arranged on the sealing disk 100. The distal skeletal part of the . The ablation section 20D is arranged on the peripheral side of the insulating section 10D, that is, on the abutment wall of the peripheral skeleton region of the sealing disc 100 . The insulating section 10D is used to reduce the occupied area of the ablation section 20D, reduce the discharge area and the ablation area of the ablation section 20D, which is beneficial to improve the ablation impedance and ensure the ablation effect of the ablation device. As shown in FIG. 7 , in this embodiment, the insulating section 10D extends to the abutting wall, further reducing the discharge area of the ablation section 20D.

It can be understood that, in some embodiments, the insulating section 10 can also be arranged on the proximal disk surface 102 of the sealing disk 100 , that is, the proximal skeleton part arranged in the sealing disk 100 . In some embodiments, the insulation section 10 can also be disposed on the support wall of the proximal disk surface 102 and the support wall of the distal disk surface 101 of the sealing disk 100 .

Referring to FIG. 7 and FIG. 8 , in some embodiments, an ablation component may also be provided on the anchoring plate 200 , and the ablation component is an ablation electrode 400 additionally provided on the skeleton. Therefore, the insulating section 10 is provided on the distal surface 101 of the sealing disk 100, and can also electrically isolate the ablation section 20D of the sealing disk 100 from the anchoring disk 200, effectively avoiding damage caused by the proximal surface of the anchoring disk 200 The ablation segment 20D on the sealing disc 100 is in contact with the distal disc surface 101 of the sealing disc 100 to conduct with the ablation component on the anchoring disc 200 .

In some embodiments, the ablation electrodes 400 on the anchoring disc 200 may be point electrodes, rod electrodes, ring electrodes and wire electrodes. The ablation electrode 400 and the skeleton of the anchoring disc 200 can be insulated connection, such as at least one of the methods of setting an insulating coating, covering an insulating film, and setting an insulating sleeve between the anchoring disc 200 and the ablation electrode 400. Insulate. It can be understood that the ablation electrode 400 and the frame of the anchoring disc 200 may also be electrically connected.

In some embodiments, a portion of the skeleton on the anchoring disc 200 is conductive and serves as an ablation component. At this time, insulation treatment is required between the sealing disc 100 and the anchoring disc 200 , for example, at least part of the connection part 300 between the sealing disc 100 and the anchoring disc 200 is made of insulating material.

It should be noted that when the anchoring disc 200 is made of braided filamentary material, the ablation section 20D and the insulating section 10D may also be provided on the anchoring disc 200 . At this time, the ablation section 20D serves as an ablation component on the anchoring disc 200 and can be used to perform tissue ablation on the inner wall tissue of the left atrial appendage. The insulating section 10D may be used to confine the ablation section 20D, or may be electrically isolated from the sealing disk 100 .

It should also be noted that, in some embodiments, two ablation components are provided on the supporting frame, and at least one ablation component is formed by the ablation section 20D. The ablation assembly formed by the ablation section 20D can be set on the sealing disc 100 or on the anchoring disc 200 .

11 and 12, the insulation section 10D includes a plurality of insulation units 110 arranged at intervals in the circumferential direction, each insulation unit 110 includes a plurality of first support rods 11D extending in bundles, and each insulation unit 110 is sheathed There is an insulating sleeve. In some embodiments, the outer surface of each insulating unit 110 is coated with an insulating coating, or the surface of each first support rod 11D in the insulating unit 110 is coated with an insulating coating. In some embodiments, an insulating sleeve is sheathed on the periphery of each insulation unit 110 , and the surface of the periphery of each insulation unit 110 is coated with an insulating coating. In some embodiments, an insulating sleeve is sheathed on the periphery of each insulating unit 110 , and the surface of each first support rod 11D in the insulating unit 110 is coated with an insulating coating.

As shown in FIG. 11 to FIG. 12 , each insulating unit 110 is linear and radially arranged from the center (converging end) of the distal disk surface 101 of the sealing disk 100 to the surroundings. It can be understood that, in this embodiment, each insulating unit 110 may also be arc-shaped, and be arranged radially from the center of the end surface or disk surface to the surroundings, that is, the insulating unit 110 is not limited here.

Referring to FIG. 7 to FIG. 11 , the ends of the plurality of insulation units 110 close to the center of the distal disk surface 101 of the sealing disk 100 are converged and are used to connect with the proximal end of the connector 300 . The peripheral distal ends of the plurality of first support rods 11D are connected to the ablation section 20D.

In some embodiments, the ends of the plurality of insulating units 110 connected to the connecting piece 300 are arranged at intervals. At this time, the connecting piece 300 can adopt an inner and outer sleeve structure, and the multiple first support rods 11D are sandwiched and bundled in between the inner and outer casings.

It can be understood that, in some other embodiments, the ends of the plurality of insulation units 110 connected to the connecting piece 300 can be gathered together and connected together as a whole.

Please refer to FIG. 12 , in some embodiments, each insulating unit 110 in the insulating section 10D is extended by a plurality of first support rods 11D in a bundle, that is, a plurality of first support rods 11D are integrated into a bundle and extended to form a Insulation unit 110 . Specifically, in this embodiment, each insulation unit 110 includes two integrated and extended first support rods 11D.

Please refer to FIG. 12 , in this embodiment, each insulation unit 110 is formed by two first support rods 11D arranged in parallel to form a bundle, which is formed by twisting and braiding each other so that the two first support rods 11D is integrated into an insulating unit 110 to ensure that the positions of the contact parts between the braided wires are relatively fixed, increase the mesh area between adjacent insulating units 110, and facilitate the fitting of insulating sleeves.

It should be noted that the number of first support rods 11D in each insulation unit 110 can also be three, four or more, and can be adjusted according to needs, that is, the number of first support rods 11D in each insulation unit 110 is not limited. limit.

It should also be noted that the plurality of first support rods 11D in each insulating unit 110 can also be welded, knotted, stitched, glued or provided with one or more methods of additional fixing parts. Relatively fixed to form a bundle of insulating units 110, to ensure that the position between the first support rods 11D in the insulating unit 110 is relatively fixed, and strengthen the structural strength of the insulating unit 110, thereby improving the supporting force and The anti-deformation ability is beneficial for the sealing disc 100 to be stably blocked at the ostium of the left atrial appendage under the pulling effect of the anchoring disc 200 at the distal end, so as to avoid excessive deformation and displacement of the disc surface after the ablation device is implanted.

In some embodiments, an insulating coating can be provided on each first support rod 11D in the insulation unit 110 or an insulating sleeve can be installed on each first support rod 11D, or each insulation unit 110 is generally insulated The insulating sleeve is coated or integrated to realize the surface insulation of the first support rod 11D to ensure the insulation effect, improve the insulation performance of the insulating section 10D of the sealing disc 100, and ensure the ablation effect of the ablation device.

In some embodiments, the multiple first support rods 11D in each insulating unit 110 may be arranged side by side and extend parallel to each other, and the multiple first support rods 11D do not need to be hinged to each other, for example, extend parallel to each other. An insulating sleeve may be fitted on each of the first support rods 11D to achieve mutual fixation of the first support rods 11D.

Referring to FIG. 12 , the ablation section 20D includes a plurality of second support rods 21D arranged around the peripheral side of the insulating section 10D. A plurality of second support rods 21D are weaved through a dense mesh to form a mesh skeleton structure surrounding the insulating section 10D.

At least two second support rods 21D are connected to the end of the first support rod 11D entering the ablation section 20D. The second support rods 21D on the support rods 11D are woven with each other to form a densely woven mesh skeleton structure.

In some embodiments, each first support rod 11D is integrated with the corresponding second support rod 21D, that is, the weaving mode is changed after the first support rod 11D extends to the ablation section 20D, and two of the same insulating unit 110 The first struts 11D extend in different directions in the ablation section 20D, forming the form of the second struts and the densely woven ablation section 20D.

Please refer to FIG. 11 , in some embodiments, in the insulating section 10D, one end of the first support rod 11D is fixedly connected to the connector 300 , that is, it is a fixed cross point, and the other end of the first support rod 11D extends into the ablation zone The section 20D is fixedly connected with a plurality of second support rods 21D, which is also a fixed cross point. Therefore, the density and number of movable intersections in the insulating section 10D are both 0, that is, a=0, so this structural solution can reduce the damage probability of the insulating coating due to friction, or facilitate the fitting of the insulating sleeve.

At the same time, in the ablation section 20D, a plurality of second support rods 21D are woven together to form a densely woven mesh skeleton structure, so the density b of the movable intersections in the ablation section 20D may or may not be 0 . It should be noted that the supporting skeleton structure in Fig. 1 to Fig. 4 can be the end surface structure of the sealing disc 100 or the anchoring disc 200 of the ablation device provided in this embodiment, specifically in this embodiment, the sealing disc 100 The structure of the sealing disc 100 and the anchoring disc 200 may be the specific structure of the support skeleton in the embodiment shown in FIGS. 1 to 4 , and is not limited to the structure of the sealing disc 100 and the anchoring disc 200 provided in this embodiment.

Embodiment 6, refer to the structure shown in FIG. 13 .

Please refer to FIG. 13 , the supporting frame of the ablation device according to the embodiment of the present invention includes an insulating section 10E and an ablation section 20E. The insulating section 10E is set at the center of one end of the support frame, for example, it can be set at the center of the distal plate 101 of the sealing plate 100 in the embodiment of FIG. 7 , and/or at the center of the proximal plate 102 of the sealing plate 100 . The ablation section 20E is distributed around the periphery of the insulating section 10E, for example, it is arranged at the peripheral edge region of the sealing disc 100 in the embodiment of FIG. 7 , and forms a ring structure around the insulating section 10E.

In some embodiments, the insulating section 10E is provided with a connecting piece 300 , and the first support rods 11E in the insulating section 10E are arranged radially around from the connecting piece 300 . In terms of process realization, the supporting frame can be heat-set, then the insulating sleeve can be fitted, and finally the connecting piece 300 can be connected in the fitting, which can greatly simplify the insulating fitting process and facilitate the realization of the insulating treatment process.

It can be understood that, in some other embodiments, the insulating section 10E may not be provided with the connecting member 300 , and the insulating section 10E is arranged radially from the center of the disk surface to the surroundings.

Referring to FIG. 13 , the insulating section 10E includes a plurality of insulating units 110 , and each insulating unit 110 includes a plurality of first support rods 11E extending in bundles. A plurality of first support rods 11E extend side by side in a bundle, and are arranged side by side to form a bundle.

Specifically, the first support rod 11E includes a middle section and end portions located at both ends of the middle section. In the same insulation unit 110 , adjacent first support rods 11E are arranged side by side. One end of the first support rod 11E is connected to the connecting piece 300 , and the other end extends into the ablation section 20E. Moreover, the insulation unit 110 formed by gathering the plurality of first support rods 11E into a bundle has a relatively high structural strength, thereby improving the supporting force and deformation resistance of the disk surface where the insulation section 10E is located.

In some embodiments, the entire surface of the insulating unit 110 extended in bundles is provided with an insulating coating, or an insulating sleeve is placed on the entire surface of the insulating unit 110, or an insulating coating is provided on the surface of the insulating unit 110 and an insulating sleeve is placed. pipe to insulate the surface of the insulating unit 110. It should be noted that the first support rods 11E can also be set as insulating rods, that is, the surface of each first support rod 11E of the insulation unit 110 is provided with an insulating coating, or the surface of each first support rod 11E is uniform. Set with insulating sleeve.

In some embodiments, in the insulation unit 110, the adjacent first support rods 11E are connected by one or more methods of splicing, welding, knotting, sewing, bonding or setting additional fixing members. The method is relatively fixed, so that the intersections between the insulating rods form fixed intersections. At this time, the density a of the movable intersections in the insulating section 10E is zero, that is, the number of movable intersections is zero, and the insulation can be reduced. Chances of breakage due to coating friction, or in favor of insulating bushing fit.

Please refer to FIG. 13 , the ablation section 20E adopts a network structure formed by weaving a plurality of support rods through a dense mesh, and the ablation section 20E is arranged around the periphery of the insulating section 10E, that is, located in the peripheral area of the disk. The ablation section 20E includes a plurality of second support rods 21E arranged around the circumference of the insulating section 10E. The end of the ablation section 20E into which the insulation unit 110 protrudes is connected with a plurality of second support rods 21E, and the plurality of second support rods 21E extend along different directions. Therefore, one end of a plurality of insulating rods of the insulating unit 110 entering the ablation section 20 can enter the ablation section 20E from multiple different directions, and then the adjacent second support rods 21E on the same insulating unit 110 can be connected to each other. Weaving, and the mutual weaving between the second support rods 21E on adjacent insulating units 110 , thereby forming a densely woven mesh structure.

It can be understood that, in the ablation section 20E, a plurality of second support rods 21E are interwoven to form a densely woven mesh skeleton structure, so the density b of the movable cross points in the ablation section 20E can be 0 or can be is not 0.

Still referring to FIG. 13 , in the insulating section 10E, a plurality of insulating units 110 are arranged at circumferential intervals around the center of the disk, and meshes 120 are formed between adjacent insulating units 110 . At least one mesh 120 is larger in area, at least one mesh 120 is larger in area than one mesh in ablation section 20E. In this embodiment, the area of each mesh 120 is larger than the area of any mesh in the ablation section 20E. In the insulating section 10E of this embodiment, by enlarging the mesh 120, that is, changing the weaving form, the number of intersections in the insulating section 10E can be directly reduced, and the possible gap between the insulating units 110 can be reduced accordingly. The number of cross-connection points is moved, thereby reducing the density and quantity of movable cross-points in the insulating section 10E, and reducing the workload of processing movable cross-points into fixed cross-points. This structural solution can reduce the damage probability of the insulating coating friction, or facilitate the installation of the insulating sleeve, can ensure the insulating effect of the insulating unit 110, improve the insulating performance of the insulating section 10 of the sealing disc 100, and then ensure the ablation of the ablation device Effect.

In some implementations, in the technical solution shown in FIG. 13 , at least one fixed intersection point may be added to the insulation section 10E. For the specific implementation of the fixed intersection point, please refer to the foregoing implementation manners.

It should be noted that, in order to achieve a larger area of at least one mesh 120 in the insulating section 10E, the area of at least one mesh 120 is larger than the area of one mesh in the ablation section 20E. Change the weaving method of the braided wire in the insulation section 10E, and weave it into a large mesh disk surface; preferably, at least part of the intersection points in the large mesh disk surface can also be treated as fixed intersection points, thereby improving the insulation performance of the insulation section 10E . Please refer to Fig. 2, in the embodiment of the present invention shown in Fig. 2, the intersection between the first supporting rods 11A in the insulating section 10A is also reduced by enlarging the mesh between adjacent first supporting rods 11A Correspondingly reduce the number of movable cross-connection points, thereby reducing the density and quantity of movable cross-points in the insulation section 10A, thereby reducing the chance of damage to the insulating coating due to friction, or facilitating the installation of the insulating sleeve , reducing the amount of insulating coating or the number of insulating sleeves, which is conducive to maintaining the mechanical properties of the supporting frame, such as better resilience.

Similarly, in the embodiments of Fig. 3, Fig. 4 and Fig. 11 of the present invention, the method of increasing the mesh is also adopted between adjacent first support rods 11, which reduces the number of intersections in the insulating section, correspondingly Reduce the density and number of movable intersections, thereby reducing the chance of damage due to friction of the insulating coating, or facilitating the installation of insulating sleeves, reducing the amount of insulating coating or the number of insulating sleeves, thereby helping to maintain the support frame Mechanical properties, such as better resilience. In addition, the formation of a large mesh in the insulating section also facilitates puncture into the interior of the LAA from the position of the large mesh for some treatment or data collection purposes after the subsequent LAA occlusion ablation device is endothelialized.

Embodiment 7, refer to the structure shown in FIG. 14 .

Please refer to FIG. 14 , the ablation device provided in this embodiment includes a support frame, and the support frame adopts a double disc structure. The support frame includes a sealing disc 100 at the proximal end for blocking the opening of the left atrial appendage and an anchoring disc 200 at the distal end for anchoring to the inner wall of the left atrial appendage.

Both the sealing disc 100 and the anchoring disc 200 are radially expandable and contractible skeleton structures. Both the sealing disc 100 and the anchoring disc 200 are made of shape memory materials.

The sealing disc 100 is made of weaving filamentary material, and the anchoring disc 200 is made of pipe cutting. It can be understood that, in some other embodiments, the anchoring plate 200 can also be made by braiding filamentary materials.

The sealing disc 100 includes a plurality of support rods, and the plurality of support rods are mutually braided to form an insulating section 10F and an ablation section 20F, respectively.

Wherein, the insulating section 10F is disposed on the supporting wall of the distal disk surface 101 and/or the proximal disk surface 102 of the sealing disk 100 , that is, a position close to the central axis. The ablation section 20F is disposed on the abutment wall of the sealing disk 100 , that is, on the peripheral frame of the sealing disk 100 , and is located in the peripheral area of the sealing disk 100 . The insulating section 10F has a larger area, and the ablation section 20F is located in the peripheral area, which can make the ablation section 20F smaller in area, larger in impedance, higher in current density, and concentrated in energy, which is conducive to improving the ablation depth of the target tissue. Effectively guarantee the ablation effect of the sealing disk 100 and the ablation device.

For the specific structures of the insulating section 10F and the ablation section 20F, reference may be made to the structure of the sealing disc 100 in the embodiment shown in FIG. 7 to FIG. 12 , which will not be repeated here.

In the ablation device of the embodiment shown in FIG. 7 , the overall longitudinal section of the sealing disk 100 has a trapezoidal structure. The distal and proximal disk surfaces of the sealing disk 100 are approximately planar. However, in this embodiment, the overall longitudinal section of the sealing disc 100 has a tapered structure, the distal disc surface of the sealing disc 100 is a tapered surface, and the proximal disc surface of the sealing disc 100 is a plane. It can be understood that, in some other embodiments, the proximal disk surface of the sealing disk 100 may also be an arcuate surface or a tapered surface.

In this embodiment, the anchoring disc 200 includes a plurality of main rods 201 , a plurality of anchor rods 202 and a plurality of struts 203 connected between the main rods 201 and the anchor rods 202 . The proximal end of the main rod 201 is used to connect the connector 300, the distal end of each main rod 201 is connected to at least two struts 203, the two struts 203 extend towards different directions, and are respectively connected to an anchor rod 202, and then The plurality of main rods 201 and the plurality of anchor rods 202 form a skeleton structure that is connected in a circumferential direction. The struts 203 can be used to increase the radial support force of the anchoring disc 200 while ensuring that the adjacent anchoring rods 202 maintain a preset distance. The anchor discs 200 are not easily entangled with each other during loading and unloading. The anchor rod 202 is arranged on the radial periphery of the main rod 201, and is used to form the side wall of the anchor plate 200 to anchor to the inner wall tissue of the left atrial appendage. The surface of the anchor rod 202 is provided with a plurality of anchor thorns 205, which are used for It anchors to the inner wall of the left atrial appendage during device release.

In the ablation device of the embodiment in FIG. 7 , the distal end of the anchor rod 202 is used to connect to the corresponding support rod 203, and the end of the anchor rod 202 away from the main rod 201 is connected to the end of the adjacent anchor rod 202 away from the main rod. 201 are connected at one end, and the anchor 205 is disposed on the far side of the ablation electrode 400 , and in some other embodiments, the anchor 205 may be disposed on the proximal side of the ablation electrode 400 . In this embodiment, the end of the anchor rod 202 away from the main rod 201 is a free end, and the free end of the anchor rod 202 is bent toward the central side by the end of the anchor rod 202 away from the strut 203 and moves toward the distal end. Bend and extend.

In this embodiment, the struts 203 are located at the most distal end of the anchoring disc 200 . When the ablation component such as the ablation electrode 400 is wrapped around the outer circumference of the anchor disc 200 , it is beneficial to maintain a predetermined distance between adjacent anchor rods 202 , and the anchor thorns 205 can be disposed near or far from the ablation electrode 400 .

Please refer to FIG. 14 , in some embodiments, the anchoring disc 200 can also be provided with an ablation component, which is formed by conducting electricity with a part of the skeleton on the anchoring disc 200 . At this time, insulating treatment is required between the sealing disc 100 and the anchoring disc 200, for example, the connecting piece 300 between the sealing disc 100 and the anchoring disc 200 is made of insulating material.

At the same time, the insulating section 10F is arranged on the distal surface 101 of the sealing disk 100, and can also be electrically isolated from the anchoring disk 200, effectively avoiding the Contact is made to conduct the ablation segment 20F on the sealing disc 100 with the ablation component on the anchoring disc 200 .

It can be understood that, in some other embodiments, the anchoring disc 200 may additionally be provided with the ablation electrode 400 on the skeleton of the anchoring disc 200 . The ablation electrode 400 may be a point electrode, a rod electrode, a ring electrode and an electrode wire.

Embodiment 8, refer to the structure shown in FIG. 15 .

Please refer to FIG. 15 , the ablation device provided in this embodiment includes a support frame, and the support frame adopts a double disc structure. The support frame includes a sealing disc 100 at the proximal end for blocking the opening of the left atrial appendage and an anchoring disc 200 at the distal end for anchoring to the inner wall of the left atrial appendage.

The main difference between the ablation device provided in this embodiment and the ablation device provided in the embodiment in FIG. The anchor disc 200 provided in the example has a different structure.

As shown in FIG. 15 , the anchoring disc 200 is made of braided wire, and the material of the braided wire can be a conductive material or an insulating material.

Specifically, the anchoring plate 200 is an inverted structure, and the anchoring plate 200 includes an inner support wall 210, an outer support wall 220, and an inner curved wall 230 connected in sequence, and the inner support wall 210, the outer support wall 220, and the inner curved wall 230 are all A series of mesh holes are formed in the mesh structure obtained by braiding silk, and the three can be braided in one piece.

The inner support wall 210 extends along the proximal end and the distal end, the proximal end of the inner support wall 210 is connected to the connector 300 , and the distal end of the inner support wall 210 is connected to the distal end of the outer support wall 220 . The radial dimension of the inner support wall 210 gradually increases from the proximal end to the distal end, and is in the shape of a trumpet, and forms a trumpet mouth at the distal end. The outer support wall 220 extends between the proximal end and the distal end, and the outer support wall 220 is arranged radially outside the inner support wall 210 for abutting and fixing on the tissue surface of the inner wall of the left atrial appendage. The proximal end of the outer support wall 220 is connected to the proximal end of the inner curved wall 230. The inner curved wall 230 extends obliquely between the proximal end and the distal end. The axis is closer. The inner curved wall 230 is disposed in the inner cavity enclosed by the inner support wall 210 and the outer support wall 220 to prevent the proximal end of the outer support wall 220 from damaging tissues.

In some embodiments, the anchoring disc 200 is provided with an ablation segment and an insulating segment, that is, the abutting wall of the anchoring disc 200, that is, at least part of the outer support wall 220 is set as the ablation segment, and the anchoring disc Parts other than the ablation section in 200 are insulation sections. The ablation section may be in the form of dense mesh weaving as shown in FIG. 15 , and the insulation section may be insulated on the surface by using the insulation unit provided in the above embodiment. For specific solutions in the ablation section and the insulation section, reference may be made to other aforementioned implementation manners.

In the case where the anchoring disc 200 is provided with an ablation segment and an insulating segment, the sealing disc 100 may be provided with an ablation segment and an insulating segment, or the sealing disc 100 may be provided with other ablation electrodes for ablation of tissue, thereby realizing a sealed disc Both the 100 and the anchor disc 200 can transmit ablation electric energy to the tissue.

In some embodiments, when the anchoring disc 200 is provided with an ablation segment and an insulating segment, the sealing disc 100 may be provided with an ablation segment and an insulating segment, or an ablation electrode, or other devices may be provided outside the body or in the delivery device. components for ablation.

In some embodiments, when the anchoring disc 200 is provided with an ablation segment and an insulating segment, the sealing disc 100 may not be provided with an ablation segment, an insulating segment, or an ablation electrode, and may be installed outside the body or in a delivery device. Other components for ablation.

Embodiment 9, refer to the structure shown in FIG. 16 .

Please refer to FIG. 16 , the ablation device provided in this embodiment includes a supporting frame, and the supporting frame adopts a double disc structure. The support frame includes a sealing disc 100 at the proximal end for blocking the opening of the left atrial appendage and an anchoring disc 200 at the distal end for anchoring to the inner wall of the left atrial appendage.

The main difference between the ablation device provided in this embodiment and the ablation device provided in the embodiment in FIG. 15 is that the structure of the anchoring disc 200 supporting the framework in this embodiment is different from that in the embodiment in FIG. 15 .

The anchoring disc 200 provided in this embodiment is made by weaving process, it can be understood that the anchoring disc 200 can also be made by cutting process. In this embodiment, the anchoring disc 200 is in the shape of a plunger, and its proximal end and distal end are both closed structures. It can be understood that the proximal end and the distal end can be respectively bundled in a connecting piece. It can be seen from FIG. 16 that the radial dimension of the proximal end of the anchoring disc 200 is larger than that of the distal end. In some other embodiments, the anchoring disc 200 may also have an isodiametric structure, that is, at different axial positions of the anchoring disc 200 , the radial dimensions are the same. As shown in FIG. 16 , the distal surface of the anchoring disc 200 protrudes distally, and the distal surface is conical. In some embodiments, the distal surface of the anchoring disc 200 is flat or concave proximally.

In the case where the anchoring disc 200 is provided with an ablation segment and an insulating segment, the sealing disc 100 may be provided with an ablation segment and an insulating segment, or the sealing disc 100 may be provided with other ablation electrodes for ablation of tissue, thereby realizing a sealed disc Both the 100 and the anchor disc 200 can transmit ablation electric energy to the tissue. In the case that the anchoring disc 200 is provided with the ablation section and the insulating section, the sealing disc 100 may not be provided with the ablation section and the insulating section, nor be provided with ablation electrodes, and other ablation devices may be provided outside the body or in the delivery device. components.

Embodiment 10, refer to the structure shown in FIG. 17 .

Please refer to FIG. 17 . FIG. 17 is a schematic structural view of a left atrial appendage occlusion ablation device according to Embodiment 10 of the present invention. In the left atrial appendage blockage ablation device shown in FIG. 7 , the skeleton in the anchoring disc 200 and the ablation electrode 400 may be electrically connected to each other, or may be insulated from each other.

In this embodiment, the anchoring disc 200 includes an anchoring frame 240, which is made of conductive metal material, which is braided or cut and heat-set. Ablation electrodes 400 are arranged on the periphery of the anchoring frame 240. The left atrial appendage shown in FIG. 17 Closing the ablation device provides some implementations in which the anchoring scaffolding 240 and the ablation electrode 400 are insulated from each other.

As shown in FIG. 17 , the anchoring disc 200 includes an insulating film 250 disposed on the surface of the anchoring frame 240, the insulating film 250 is sandwiched between the anchoring frame 240 and the ablation electrode 400, and the material of the insulating film 250 includes an insulating material, so that Avoid the problem that the ablation electrode 400 is electrically coupled with the anchoring frame 240 when the ablation electrode 400 is in the ablation state, so that the anchoring frame 240 conducts electricity. That is, the insulating film 250 is used to realize the insulation between the ablation electrode 400 and the anchoring frame 240 . The insulating film 250 can also reduce the contact area between the anchoring frame 240 and the inner wall of the left atrial appendage, reducing the stimulation and damage of the anchoring frame to tissues.

The insulating film 250 is made of insulating material, so that the overall insulating performance of the insulating film 250 is enhanced. In some other embodiments, the inner surface and/or the outer surface of the insulating film 250 are both provided with an insulating coating.

Optionally, in some embodiments, the material of the insulating film 250 includes an insulating and degradable material, that is, the insulating film 250 is made of an insulating and degradable material, which is beneficial to improve the biocompatibility of the left atrial appendage occlusion ablation device. The insulating degradable materials include but are not limited to polylactic acid (polylactic acid, PLA), polycaprolactone (Polycaprolactone, PCL), or a copolymer or blend of several polymers.

In some other embodiments, the material of the insulating film 250 may also include insulating non-degradable materials. The non-degradable materials have stable chemical properties, correspondingly stable structures that are not easily damaged, and have relatively stable long-term mechanical properties, especially mechanical properties. Insulating non-degradable materials include but are not limited to polyimide, polysulfone (Polysulfone, PSF), polysulfone resin (Polyethersulfone, 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, One of silicone rubber and other polymer materials or any combination of them.

As shown in FIG. 17 , the insulating film 250 covers the outer wall of the distal portion of the anchoring frame 240. In some embodiments, the proximal end of the insulating film 250 can extend proximally to cover the proximal end of the anchoring frame 240. Or near the proximal end, in some embodiments, the insulating film 250 covers or wraps the proximal end of the anchoring scaffold 240 .

In this embodiment, the sealing disc 100 is provided with at least one flow blocking membrane (not shown in the figure) for preventing the thrombus inside the left atrial appendage from flowing out to the left atrium. The flow blocking film can be disposed on the inner cavity or the outer surface of the sealing disk 100 . Preferably, the insulating film 250 provided on the surface of the anchoring frame 240 also has flow-blocking performance, so as to improve the flow-blocking performance of the left atrial appendage occlusion ablation device. In this embodiment, the distal end of the insulating film 250 is closed, so as to ensure the flow blocking performance of the insulating film 250 .

In this embodiment, the insulating film 250 is fixed on the surface of the anchoring frame 240 by suturing. In other embodiments, the insulating film 250 is fixed on the anchoring frame 240 by means of dipping, spraying, bonding, hot pressing and the like.

The ablation electrode 400 can be fixed on the surface of the insulating film 250 by means of suturing, heat pressing, bonding and the like. In this embodiment, the ablation electrode 400 is fixed on the surface of the insulating film 250 through a sewing process. The ablation electrode 400 is provided with a plurality of suture points 410, and the suture points 410 and the insulating film 250 are sutured and fixed. In this embodiment, the ablation electrode 400 is wavy and ring-shaped. In other embodiments, the ablation electrode 400 can be a point electrode, a plurality of rod electrodes, a plurality of arc electrodes, a plurality of ring electrodes, etc. . The ablation electrode 400 has crests and troughs. In order to prevent the ablation electrode 400 from sliding relative to the insulating film 250 in the axial and circumferential directions after sewing, the stitching point 410 is selected at the peaks and troughs of the ablation electrode 400 . In this embodiment, the suture point 410 is set corresponding to the anchoring frame 240, that is, the suture point 410 is set corresponding to the anchor rod 202, and the ablation electrode 400 can be sutured to the insulating film 250 at the suture point 410; or at the suture point 410, The ablation electrode 400, the insulating film 250 and the anchoring frame 240 (specifically, the anchoring rod 202) are sutured together. Preferably, during the process of suturing the ablation electrode 400, the threading hole formed in the insulating film 250 at the position corresponding to the suture point 410 can be filled with a polymer insulating material such as insulating colloid, thereby reducing the distance between the ablation electrode 400 and the anchoring frame 240. The probability of electrical coupling between them.

In some embodiments, on the basis of using the insulating film 250 to electrically isolate the anchoring frame 240 from the ablation electrode 400, the surface of the anchoring frame 240 is also provided with an insulating coating and/or is sheathed with an insulating sleeve, so as to improve the strength of the anchoring frame. The insulation performance between the fixed frame 240 and the ablation electrode 400 is determined.

In some embodiments, the anchoring frame 240 and the ablation electrode 400 are insulated by setting an insulating sleeve; in some embodiments, the anchoring frame 240 and the ablation electrode 400 are insulated by setting an insulating coating; In some implementations, an insulating coating is provided between the anchoring frame 240 and the ablation electrode 400 , and an insulating sleeve is sheathed to achieve insulation between the two.

Embodiment eleven, refer to the structure shown in FIG. 18 .

Please refer to FIG. 18 . FIG. 18 is a schematic structural diagram of a left atrial appendage occlusion ablation device according to Embodiment 11 of the present invention.

The difference between the ablation device for left atrial appendage occlusion provided in this embodiment and the ablation device for left atrial appendage occlusion in FIG. , that is, the crests and troughs of the ablation electrode 400 are set corresponding to the gaps between the anchor rods 202 in the anchoring frame 240, so that during the process of suturing and fixing the ablation electrode 400 to the insulating film 250, the insulating film 250 corresponds to the threading formed by the suture point 410 The holes and the anchor rods 202 are staggered to reduce the probability of electric coupling between the ablation electrode 400 and the anchor frame 240 and improve the safety and reliability of the left atrial appendage occlusion ablation device.

In this embodiment, the axial range of the anchoring skeleton 240 covered by the insulating film 250 is larger than that in FIG. 17 , that is, the distance between the proximal end of the insulating film 250 in FIG. The proximal end of the fixed frame 240 is closer to improve the flow resistance of the insulating film 250 .

It should be noted that the specific technical solutions in the above embodiments can be applied to each other without violating the technical principle of the present invention.

While this invention has been described with reference to several exemplary embodiments, it is understood that the terms which have been used are words of description and illustration, rather than of limitation. Since the present invention can be embodied in many forms without departing from the spirit or essence of the invention, it should be understood that the above-described embodiments are not limited to any of the foregoing details, but should be construed broadly within the spirit and scope of the appended claims. , all changes and modifications falling within the scope of the claims or their equivalents shall be covered by the appended claims.

Claims

An ablation device, characterized in that it includes a support frame made of conductive braided wire, the support frame includes an ablation section for electrical ablation of tissue and an insulating section other than the ablation section, the ablation section segment and said insulating section each comprise a plurality of support rods;

The density of movable intersections formed between adjacent support rods in the insulating section is a, and the density of movable intersections formed between adjacent support rods in the ablation section is b, if b is not 0, then a<b; if b is 0, then a=b=0;

Wherein, relative movement between adjacent support rods can occur at the movable intersection.
The ablation device according to claim 1, characterized in that at least part of the surface of the support rod in the insulating section is coated with an insulating coating and/or is covered with an insulating sleeve.
The ablation device according to claim 1, wherein the intersections of adjacent support rods in the insulating section include fixed intersections, and at the fixed intersections, the corresponding support rods The positions between them are relatively fixed.
The ablation device according to claim 3, characterized in that, in the fixed cross point, the adjacent support rods are spliced, welded, knotted, stitched, glued or provided with additional fixing elements One or more of the methods are relatively fixed.
The ablation device according to claim 3, wherein the surface at the fixed intersection is coated with an insulating coating.
The ablation device according to any one of claims 1-5, wherein meshes are formed in the ablation section and the insulation section, and at least one mesh in the insulation section has an area larger than the The area of one of the meshes in the ablation section.
The ablation device according to claim 6, wherein the density a of the movable intersections in the insulating section is zero.
The ablation device according to claim 6, wherein in the insulating section, the support rod is formed with a plurality of insulating units, each of which includes at least one of the insulating units extending in bundles. support rod;

An insulating sleeve is sheathed on the periphery of each insulating unit, and/or the surface of the periphery of each insulating unit is coated with an insulating coating, and/or the surface of each support rod in the insulating unit is coated with an insulating coating.
The ablation device according to claim 8, wherein at least one of said insulating units comprises a plurality of said support rods, wherein adjacent said support rods are arranged side by side.
The ablation device according to claim 9, wherein in the at least one insulating unit, adjacent support rods are spliced, welded, knotted, stitched, bonded or additional Relatively fixed by one or more ways of the fixed parts.
The ablation device according to claim 9, wherein at one end of the at least one insulating unit entering the ablation section, the plurality of support rods in the at least one insulating unit are at least from Two different directions enter the ablation zone.
The ablation device according to any one of claims 1-11, wherein the supporting frame includes an abutment wall in contact with the left atrial appendage tissue and a support wall in contact with the abutment wall, and the abutment wall is in contact with the abutment wall. a wall disposed on a peripheral edge of the ablation device;

The ablation section is arranged on the abutment wall; the insulation section is at least arranged on the support wall.
The ablation device according to claim 12, wherein the proximal end or the distal end of the insulating section forms a converging end for converging the support rod, and the insulating section is formed by the converging end Arranged radially to the circumferential edge.
The ablation device according to claim 12, wherein the support frame comprises a sealing disc at its proximal end for blocking the opening of the left atrial appendage and an anchoring disc at its distal end for anchoring the inner wall of the left atrial appendage ;

Both the ablation segment and the insulating segment are disposed on the sealing disc; and/or, the ablation segment and the insulating segment are both disposed on the anchoring disc.
The ablation device according to claim 12, wherein the supporting frame comprises a sealing disc at the proximal end for blocking the opening of the left atrial appendage and an anchoring disc at the distal end for anchoring the inner wall of the left atrial appendage, Both the ablation section and the insulation section are arranged on the sealing disk; at least two ablation assemblies for electrical ablation of tissues are arranged on the support frame, one of the ablation assemblies is controlled by the sealing disk. An ablation segment is formed on a disc, and another of said ablation components is disposed on said anchoring disc.
The ablation device according to claim 15, wherein the sealing disk comprises a proximal disk surface and a distal disk surface, the proximal disk surface is arranged at the proximal end of the distal disk surface, and the proximal disk surface and the The distal disk surfaces meet at the circumferential edge of the sealing disk and form the abutment wall;

The ablation assembly formed by the ablation section is arranged on the abutment wall of the sealing disk, and the insulating section is arranged on the support wall of the sealing disk on the surface of the distal end disk.
The ablation device according to claim 16, wherein the insulating section is also provided on the support wall of the sealing disk on the surface of the proximal disk.