CN118356223A

CN118356223A - Left auricle plugging device

Info

Publication number: CN118356223A
Application number: CN202310274919.9A
Authority: CN
Inventors: 李建民; 丘家明; 陈杰
Original assignee: Hangzhou Dinova EP Technology Co Ltd
Current assignee: Hangzhou Dinova EP Technology Co Ltd
Priority date: 2023-01-17
Filing date: 2023-03-15
Publication date: 2024-07-19

Abstract

The embodiment of the application provides a left atrial appendage occlusion device, which comprises a sealing part and an anchoring part, wherein the sealing part is arranged at the near side of the anchoring part, the anchoring part comprises an anchoring framework and a film body covered on the outer surface of the anchoring framework, the anchoring framework comprises a distal end surface and a side wall, the side wall is connected with the distal end surface, the film body covers at least part of the side wall, and the periphery connected with the side wall in the distal end surface is provided with an opening at the outer side of the distal end surface. The membrane body in the outside of the anchoring framework is provided with the opening, so that the volume of the membrane body arranged on the anchoring part is reduced, the membrane body is bound to the anchoring framework when the anchoring part rebounds, the rebound performance of the anchoring framework is improved, the sheath retraction force of the left auricle occluder is reduced, and the anchoring part can smoothly retract the sheath.

Description

Left auricle plugging device

Technical Field

The application relates to the technical field of medical instruments, in particular to a left auricle occluder.

Background

The treatment of diseases by interventional methods through catheter technology is currently taking advantage of more and more therapeutic methods, which can place a wide variety of materials, instruments and drugs into the heart, arteriovenous vessels of the human body. The plugging device is placed into the left auricle through a catheter intervention method, so that the thrombus formed by the left auricle due to atrial fibrillation can be prevented from ascending to the brain to cause stroke, or the thrombus can be prevented from reaching other parts of the body through the blood circulation system of the human body to cause systemic embolism.

Some existing left auricle occluders are of a double-disc structure, and comprise a sealing disc for occluding the mouth of the left auricle and an anchoring disc for anchoring in the left auricle, wherein a flow blocking film is arranged on the outer side of the anchoring disc to cover the outer side surface of the anchoring disc. However, during loading of the instrument into the sheath, the anchor disc is prone to problems of difficult radial dimension compression and difficult sheath retraction.

Disclosure of Invention

The embodiment of the application provides a left atrial appendage occlusion device, which comprises a sealing part and an anchoring part, wherein the sealing part is arranged at the near side of the anchoring part, the anchoring part comprises an anchoring framework and a film body covered on the outer surface of the anchoring framework, the anchoring framework comprises a distal end surface and a side wall, the side wall is connected with the distal end surface, the film body covers at least part of the side wall, and the periphery connected with the side wall in the distal end surface is provided with an opening at the outer side of the distal end surface.

According to the embodiment of the application, the opening is formed in the membrane body outside the anchoring framework, so that the volume of the membrane body arranged on the anchoring part is reduced, the membrane body is bound to the anchoring framework when the anchoring part rebounds, the rebound performance of the anchoring framework is improved, the sheath retraction force of the left atrial appendage occlusion device is reduced, the anchoring part can smoothly retract the sheath, normal circulation of blood in the left atrial appendage and a left atrium is facilitated, and the resistance in the release process of the left atrial appendage occlusion device is reduced.

The membrane body covers at least part of the side wall and the periphery connected with the side wall in the distal end face, so that the side wall and the distal end face of the anchoring framework are convenient to maintain certain structural stability.

In a state where the anchoring portion is implanted in the left atrial appendage, the anchoring portion is pressed and fixed by the tissue in the radial direction, which may cause the anchoring portion to be elongated in the axial direction, and the peripheral edge of the distal end face connected to the side wall may also abut against the tissue of the inner wall of the left atrial appendage. In the embodiment of the application, as the membrane body covers at least part of the side wall and the part of the distal end surface connected with the side wall, the membrane body can be blocked between the anchoring framework and the tissue in a larger area, so that the damage to the tissue caused by the direct contact of the anchoring framework is reduced or avoided, the stimulation of the framework material to the tissue is reduced, and the safety of the left atrial appendage occlusion device is improved.

The membrane body is provided with the opening in the distal side of distal end face, covers the part and at least partial lateral wall that are connected with the lateral wall in the distal end face for open area is less, is convenient for fix the opening edge, prevents the membrane body at opening edge department damage, guarantees the integrality of membrane body, is convenient for block the passing through of thrombus.

Drawings

In order to more clearly illustrate the technical solutions of the embodiments of the present application, the drawings that are needed in the embodiments will be briefly described below, it being understood that the following drawings only illustrate some embodiments of the present application and should not be considered as limiting the scope, and other related drawings may be obtained according to these drawings without inventive effort for a person skilled in the art.

Fig. 1A is a schematic structural view of a left atrial appendage occlusion device according to a first embodiment of the present application;

Fig. 1B is a schematic structural view of a support skeleton in the left atrial appendage occlusion device provided in fig. 1A;

Fig. 1C is a schematic structural diagram of a membrane body in the left atrial appendage occlusion device provided in fig. 1A;

fig. 2A is a schematic structural view of a left atrial appendage occlusion device according to a second embodiment of the present application;

fig. 2B is a schematic structural view of a support skeleton in the left atrial appendage occlusion device provided in fig. 2A;

fig. 2C is a schematic structural diagram of a membrane body in the left atrial appendage occlusion device provided in fig. 2A;

FIG. 2D is an enlarged schematic view of the bottom portion of FIG. 2C with an opening formed therein;

FIG. 2E is a schematic view of the spacer of FIG. 2D;

FIG. 2F is a schematic illustration of forming an edge seal based on FIG. 2D;

FIG. 2G is an enlarged schematic view of a bottom-forming opening area according to an alternative embodiment;

fig. 3A is a schematic structural view of a left atrial appendage occlusion device according to a third embodiment of the present application;

FIG. 3B is a schematic view of the left atrial appendage occlusion device of FIG. 3A from another angle;

FIG. 3C is a schematic cross-sectional view of the left atrial appendage occlusion device of FIG. 3B;

Fig. 3D is a schematic structural view of a left atrial appendage occlusion device provided in an alternative embodiment;

fig. 4A is a schematic structural diagram of a left atrial appendage occlusion device 400 according to a fourth embodiment of the present application;

FIG. 4B is a schematic cross-sectional view of the left atrial appendage occlusion device of FIG. 4A;

FIG. 4C is a schematic view of a partial structure of the left atrial appendage occlusion device of FIG. 4A;

FIG. 4D is a schematic view of the pull wire of FIG. 4C during formation;

FIG. 4E is a schematic view of the film body and the pulling wire of FIG. 4A at another angle;

fig. 5A is a schematic structural diagram of a film body according to another modified embodiment of the present application;

Fig. 5B is an enlarged schematic view of the V region in fig. 5A.

Detailed Description

For the purpose of making the objects, technical solutions and advantages of the embodiments of the present application more apparent, the technical solutions of the embodiments of the present application will be clearly and completely described below with reference to the accompanying drawings in the embodiments of the present application, and it is apparent that the described embodiments are some embodiments of the present application, but not all embodiments. The components of the embodiments of the present application generally described and illustrated in the figures herein may be arranged and designed in a wide variety of different configurations.

Thus, the following detailed description of the embodiments of the application, as presented in the figures, is not intended to limit the scope of the application, as claimed, but is merely representative of selected embodiments of the application. All other embodiments, based on the embodiments of the application, which are apparent to those of ordinary skill in the art without inventive faculty, are intended to be within the scope of the application.

It should be noted that: the same or similar reference numerals and letters denote similar items in the following figures, and thus once an item is defined in one figure, no further definition or explanation thereof is necessary in the following figures.

In the description of the present application, it should be noted that, if the terms "upper", "lower", "inner", "outer", and the like indicate an azimuth or a positional relationship based on the azimuth or the positional relationship shown in the drawings, or an azimuth or the positional relationship conventionally placed when the product of the application is used, it is merely for convenience of describing the present application and simplifying the description, and it does not indicate or imply that the apparatus or element to be referred to must have a specific azimuth, be configured and operated in a specific azimuth, and thus should not be construed as limiting the present application.

Furthermore, the terms "first," "second," and the like, if any, are used merely for distinguishing between descriptions and not for indicating or implying a relative importance.

The features of the embodiments of the present application may be combined with each other without collision.

Definition of paraphrasing:

Left auricle: from the left atrium to the left atrial appendage.

Proximal and distal: along the delivery path of the medical device, the medical device or medical device wherein the end of the member that is relatively adjacent to the operator is proximal and the end that is relatively distal from the operator is distal. In particular, in an embodiment of the present application, a left atrial appendage occlusion device is provided, where the left atrial appendage occlusion device is delivered along a delivery channel by a delivery device and released to the left atrial appendage, a distal end of the delivery device is connected to a proximal end of the left atrial appendage occlusion device, and one end of the left atrial appendage occlusion device or a component thereof, which is closer to the delivery device, is a proximal end, and one end, which is farther from the delivery device, is a distal end.

Proximal and distal: along the delivery path of the medical device, the medical device or the medical device wherein the side of the component that is relatively adjacent to or facing the operator is proximal and the side that is relatively away from or facing away from the operator is distal. In particular in the present application, the delivery device is used to connect the proximal end of the left atrial appendage occlusion device from the proximal side, the side adjacent or facing the delivery device being proximal and the side remote or facing away from the delivery device being distal, of the left atrial appendage occlusion device or component thereof.

First embodiment

Referring to fig. 1A to 1C, fig. 1A is a schematic structural diagram of a left atrial appendage occlusion device 100 according to a first embodiment of the present application. Fig. 1B is a schematic structural view of the support skeleton 101 in the left atrial appendage occlusion device 100 provided in fig. 1A. Fig. 1C is a schematic structural diagram of the membrane 160 in the left atrial appendage occlusion device 100 provided in fig. 1A.

The first embodiment of the present application provides a left atrial appendage occlusion device 100, comprising a sealing portion 110 and an anchoring portion 130, wherein the sealing portion 110 is disposed on the proximal side of the anchoring portion 130.

The anchoring portion 130 is used for being combined with the tissue of the inner wall of the left atrial appendage and being fixed in the left atrial appendage, the anchoring portion 130 comprises an anchoring skeleton 140 and a membrane 160 covering the outer surface of the anchoring skeleton 140, the anchoring skeleton 140 comprises a distal end face 142 and a side wall 145, the side wall 145 is connected with the distal end face 142, the membrane 160 covers at least part of the side wall 145 and a peripheral edge 143 connected with the side wall 145 in the distal end face 142, and the membrane 160 is provided with an opening 161 at the distal side of the distal end face 142.

The left atrial appendage occlusion device 100 is used for occluding a left atrial appendage, and after the left atrial appendage occlusion device 100 is implanted into the left atrial appendage, thrombus in the left atrial appendage can be prevented from being caused to stroke due to atrial fibrillation flowing into a left atrium. The membrane 160 covers the outer surface of the anchoring skeleton 140, that is, the membrane 160 is disposed at the periphery of the anchoring skeleton 140, and in the case that the left atrial appendage occlusion device 100 is implanted in a living body, the membrane 160 is blocked between the anchoring skeleton 140 and the tissue, so that the stimulation of the anchoring skeleton 140 to the tissue is reduced.

In the embodiment of the application, the membrane 160 on the outer side of the anchoring framework 140 is provided with the opening 161, the anchoring framework 140 surrounds to form an inner cavity, the outer side refers to the side of the anchoring framework 140 away from the inner cavity, the outer side (the side away from the inner cavity) of the membrane 160 is provided with the opening, which is favorable for reducing the volume of the membrane 160 arranged on the anchoring part 130 and the binding of the membrane 160 to the anchoring framework 140 when the anchoring part 130 rebounds, improving the rebound performance of the anchoring framework 140, reducing the sheath retraction force of the left atrial appendage occlusion device 100, facilitating the smooth sheath retraction of the anchoring part 130, and also favorable for the normal circulation of blood in the left atrial appendage and the left atrial appendage to reduce the resistance in the release process of the left atrial appendage occlusion device 100.

The membrane 160 covers at least a portion of the side wall 145 and the peripheral edge 143 of the distal surface 142 that is connected to the side wall 145 to facilitate maintaining the structural stability of the side wall 145 and the distal surface 142 of the anchoring frame 140.

In a state where the anchor 130 is implanted in the left atrial appendage, the anchor 130 is pressed and fixed by the tissue in the radial direction, which may cause the anchor 130 to be elongated in the axial direction, and the peripheral edge 143 of the distal end face 142 connected to the side wall 145 may also abut against the tissue of the inner wall of the left atrial appendage. In the embodiment of the application, since the membrane 160 covers at least part of the side wall 145 and the portion (the peripheral edge 143) of the distal end surface 142 connected with the side wall 145, the membrane 160 can be blocked between the anchoring skeleton 140 and the tissue in a larger area, so that the damage to the tissue caused by the direct contact of the anchoring skeleton 140 is reduced or avoided, the stimulation of the supporting skeleton material to the tissue is reduced, and the safety of the left atrial appendage occlusion device 100 is improved.

The membrane 160 is provided with an opening 161 on the distal side of the distal end surface 142, and covers the portion (the peripheral edge 143) of the distal end surface 142 connected to the side wall 145 and at least a portion of the side wall 145, so that the area of the opening 161 is smaller, the edge of the opening 161 is convenient to fix, the membrane 160 is prevented from being damaged at the edge of the opening 161, the integrity of the membrane 160 is ensured, and thrombus is convenient to block.

The left atrial appendage occlusion device 100 comprises a support frame 101 and a membrane 160 disposed on the surface of the support frame 101. The support frame 101 is a self-expanding device, and the support frame 101 may be an elastic metal support frame or an elastic nonmetal support frame. When the left atrial appendage occlusion device 100 is delivered through the sheath, the diameter of the support scaffold 101 can be contracted to a smaller state (delivery state) for delivery in the sheath; when the left atrial appendage occlusion device 100 is released in the heart, the support frame 101 is guided to smoothly enter the appropriate position in the inner cavity of the left atrial appendage, and the support frame 101 can be automatically expanded to enable the outer wall of the support frame 101 to be completely attached to the inner wall of the opening of the left atrial appendage.

The supporting skeleton 101 has elasticity to realize radial compression and expansion, and can be generally made of shape memory alloy with better biocompatibility, including but not limited to cobalt-chromium alloy, nickel-titanium alloy, 316L stainless steel, pure tantalum, titanium alloy, gold, platinum-iridium alloy and the like, and the supporting skeleton 101 can also be made of degradable or non-degradable high polymer materials, such as one or two or copolymers of polylactic acid and polydioxanone.

The supporting framework 101 includes a plurality of supporting rods connected with each other to form a net structure, a rod structure or a frame structure of the supporting framework 101. In the present embodiment, the support frame 101 has a plunger shape, and specifically, the support frame 101 has a substantially cylindrical shape, and the proximal end and distal end of the support frame 101 are closed. In other variations, the proximal end of the support frame 101 is closed and the distal end is formed with an opening that is not so large that there is no portion (peripheral edge 143) of its distal face that connects to the side wall 145.

In this embodiment, the supporting framework 101 is formed by braiding wires, and in a modified embodiment, the supporting framework 101 may be formed by cutting and shaping a nickel-titanium alloy pipe, or may be processed by combining local braiding with local pipe cutting, and different parts may be welded or fixed by other parts additionally arranged. The overall shape of the supporting frame 101 may be any of a variety of suitable shapes, such as a disk shape and a cone shape, and is not limited thereto.

As shown in fig. 1B, in the present embodiment, the supporting frame 101 has a plunger shape, that is, a substantially cylindrical shape, and includes a seal frame 120 provided on the proximal side and an anchor frame 140 provided on the distal side. The supporting framework 101 is an integrally woven and formed structure, and the sealing framework 120 and the anchoring framework 140 are connected with each other to obtain the supporting framework 101 in a single-disc form.

The surface of the supporting framework 101 is provided with at least one film 160, and the film 160 is used for covering the outer surface of the supporting framework 101. The membrane 160 is used to block thrombus outflow in the left atrial appendage, i.e., the membrane 160 is a flow blocking membrane. In this embodiment, the membrane 160 wraps the supporting framework 101 and covers the proximal end surface of the supporting framework 101 in the radial direction, and the membrane 160 is blocked at the opening of the left atrial appendage to prevent thrombus from flowing into the left atrium. After the left atrial appendage occlusion device 100 is released in vivo, the membrane 160 can be blocked between the supporting framework 101 and the tissue on the inner wall of the left atrial appendage, the supporting framework 101 contacts the tissue through the membrane 160, the stress of the tissue is more uniform, and the stimulation of the supporting framework 101 material to the tissue is also reduced.

The membrane 160 may be attached to the support frame 101 by stitching, bonding, dipping, spraying, or hot pressing. The membrane 160 material includes, but is not limited to, at least one of PET, PTFE, polyimide, polysulfone, polyomasulfone resin, polyvinylpyrrolidone, polymethyl methacrylate, hydrogenated styrene-butadiene block copolymer, thermoplastic polyurethane elastomer, polyurethane, parylene and silicone rubber, or a copolymer or blend of one or more polymers of polylactic acid, polycaprolactone.

Preferably, the left atrial appendage occlusion device 100 includes a sealing portion 110 disposed at a proximal end and an anchoring portion 130 disposed at a distal end, the sealing portion 110 being disposed proximal of the anchoring portion 130. The sealing portion 110 is configured to be released into the left atrial appendage portion to seal the left atrial appendage, and the anchoring portion 130 is configured to be released into the left atrial appendage lumen to be secured within the left atrial appendage. Accordingly, the support frame 101 includes a sealing frame 120 and an anchoring frame 140, and the anchoring frame 140 is disposed on the distal side of the sealing frame 120. The sealing skeleton 120 and the anchoring skeleton 140 each include a plurality of support rods, and adjacent support rods are connected to each other to form a mesh structure, a rod structure or a frame structure. In this embodiment, the sealing skeleton 120 and the anchoring skeleton 140 are woven by using wires into a mesh structure. The sealing skeleton 120 and the anchoring skeleton 140 may be in a unitary structure or a separate structure.

The sealing part 110 includes a sealing skeleton 120, and preferably, the sealing part 110 further includes at least one film body disposed on the sealing skeleton 120. The membrane body is used for blocking thrombus in the left auricle from flowing out of the left auricle along with the release of the sealing part 110 at the left auricle. The membrane may be the proximal portion of the membrane 160 shown in fig. 1A, i.e., the membrane 160 in the anchor 130 not only covers the surface of the anchor backbone 140, but also extends to the seal backbone 120, covering at least a portion of the surface of the seal backbone 120.

The membrane body of the seal skeleton 120 may be disposed on the outer surface of the seal skeleton 120 or in the inner cavity of the seal skeleton 120, and the membrane body may be disposed on the proximal end, the distal end, or a position between the proximal end and the distal end of the seal portion 110. In some embodiments, the outside of the seal case 120 is covered with a membrane. The number of the membrane bodies arranged on the sealing skeleton 120 can be one or more, and the membrane bodies can be mutually spaced or connected.

The anchor 130 includes an anchor skeleton 140 and a membrane 160 covering an outer surface of the anchor skeleton 140. In the present embodiment, the membrane 160 covers the outside of the anchor skeleton 140, and the outside surface of the seal skeleton 120 in the seal portion 110.

The left atrial appendage occlusion device 100 includes a first connector 103 and a second connector 104.

The first connector 103 is disposed at the proximal end of the sealing portion 110 for detachable connection with the delivery device. The proximal end of the seal case 120 is connected to the first connector 103, and specifically, the proximal end of the braid wires in the seal case 120 are bonded to the first connector 103.

The distal end of the anchoring framework 140 is connected to the second connector 104, and in particular, the ends of the braided filaments in the anchoring framework 140 are bonded to the second connector 104. In this embodiment, at least a portion of the second connector 104 is exposed on the distal side of the anchoring framework 140, i.e., the second connector 140 exposed on the surface of the anchoring framework 140 can be seen as viewed from the distal side of the anchoring framework 104 toward the proximal side thereof.

As shown in fig. 1B, the anchoring skeleton 140 is a distal portion in the support skeleton 101, including a distal end face 142 and a sidewall 145 that are interconnected. Distal end face 142 is disposed at the distal end of anchoring skeleton 140, and side wall 145 extends circumferentially around anchoring skeleton 140, side wall 145 being adapted for anchoring to the left atrial appendage inner wall tissue. Preferably, the outer side surface of the side wall 145 is provided with anchoring points 146, and the anchoring points 146 are used for anchoring to the inner wall of the left atrial appendage during the release of the left atrial appendage occlusion device, so as to improve the anchoring performance of the anchoring portion 130. The anchor 146 extends between a proximal end and a distal end of the left atrial appendage occlusion device 100, the distal end of the anchor 146 being connected to a support rod in a sidewall 145 of the anchoring framework 140, the proximal end of the anchor 146 extending radially outward. In the present embodiment, the number of anchor points 146 is plural, and the anchor points are provided at the same axial position of the anchor 130. In some embodiments, the plurality of anchors 146 are disposed at different axial locations of the anchor 130, and the anchors 146 may also be disposed at locations other than the side wall 145, such as at the junction of the side wall 145 and the distal end face 142, i.e., the peripheral edge 143 of the distal end face 142, and the peripheral edge of the sealing skeleton 120.

As shown in fig. 1B, the distal surface 142 is planar, and in some embodiments, the distal surface 142 may be a combination of multiple planes, an arc, and a combination of planes and arcs.

The membrane 160 covers at least a portion of the side wall 145 and the peripheral edge 143 of the distal surface 142 that is connected to the side wall 145. In the present embodiment, the membrane 160 covers all the side walls 145 and extends from the direction of the anchor portion 130 toward the direction of the sealing portion 110, and covers the circumferential periphery and the proximal end face of the sealing skeleton 120, thereby avoiding direct contact between the side walls of the supporting skeleton 101 (the side walls 145 of the anchor skeleton 140 and the circumferential periphery of the sealing skeleton 120) and the inner wall of the left atrial appendage, and reducing or avoiding direct contact between the supporting skeleton 101 and the tissue after the device is released, and causing irritation to the tissue.

As shown in fig. 1A-1C, the membrane 160 is provided with an opening 161 distally of the distal end face 142. The volume of the membrane 160 arranged on the anchoring portion 130 is reduced, the membrane 160 is bound to the anchoring skeleton 140 when the anchoring portion 130 rebounds, the rebound performance of the anchoring skeleton 140 is improved, the sheath retraction force of the left atrial appendage occlusion device 100 is reduced, the anchoring portion 130 can smoothly retract the sheath, normal circulation of blood in the left atrial appendage and the left atrium is facilitated, and the resistance of the left atrial appendage occlusion device 100 in the release process is reduced.

The membrane 160 includes a side portion 165 and a bottom portion 162, the side portion 165 being adapted to cover the outside of the side wall 145 for contacting the inner wall of the left atrial appendage upon release of the left atrial appendage occlusion device 100. The bottom 162 is disposed at the distal end of the membrane 160, and is a distal end surface of the membrane 160, and is used for covering the peripheral edge 143 connected to the sidewall 145 in the distal end surface 142. In this embodiment, the outer periphery of the bottom 162 is circular, and the inner periphery 163 of the bottom 162 encloses the opening 161. In the film body 160, the side portion 165 is used for forming a circumferential side wall of the film body 160, an outer periphery of the bottom portion 162 is connected with a distal edge of the side portion 165, an opening 161 is defined by an inner periphery 163 of the bottom portion 162, and the opening 161 is disposed corresponding to the second connecting member 104.

In the present embodiment, the number of the openings 161 is one, and the shapes of the openings 161 and the outer periphery of the bottom 162 are circular. In the modified embodiment, the number of the openings 161 is not limited, and the shapes of the openings 161 and the outer periphery of the bottom 162 may be any one of regular or irregular shapes such as a circle, an ellipse, a triangle, a rectangle, a trapezoid, etc., and the shape of the openings 161 may be other shapes for the inner periphery 163 to be bonded to the side wall of the second connector 104. In the present embodiment, the opening 161 is provided corresponding to the second connector 104, and in a modified embodiment, the opening 161 is not limited to being provided corresponding to the second connector 104.

Preferably, the bottom portion 162 has an inner diameter less than or equal to 1/2 the radial dimension of the side portion 165. The membrane 160 is flexible and covers the outside of the supporting frame 101, and the size of the membrane 160 is directly related to the size of the supporting frame 101 inside the membrane 160. The inner diameter of the bottom 162 and the radial dimensions of the side 165 are the corresponding dimensions that can be measured by the bottom 162 and the side 165 of the membrane 160 under the supporting action of the supporting frame 101 after the left atrial appendage occlusion device 100 is completely released in its natural state. The natural state refers to a fully expanded state of the left atrial appendage occlusion device 100 without external force, e.g., the left atrial appendage occlusion device 100 is not compressed by the delivery device and the inner wall of the left atrial appendage is compressed.

The inner diameter of the base 162 refers to the radial dimension of the inner periphery 163 of the base 162 that defines the opening 161. In the present embodiment, the inner peripheral edge 163 of the bottom 162 is circular, and the inner diameter of the inner peripheral edge 163 of the bottom 162 is the diameter of the inner peripheral edge 163.

The side portion 165 is circular tubular, and the radial dimension of the side portion 165 is the diameter of the side portion 165.

In the modified embodiment, when the inner peripheral edge 163 of the bottom 162 is shaped other than circular, the inner diameter of the bottom 162 is the maximum radial dimension of the inner peripheral edge 163. The radial dimension of the side portion 165 is the maximum radial dimension of the side portion 165 in the case where the cross section perpendicular to the axis thereof is other than circular.

The inner diameter of the inner periphery 163 of the bottom 162 is smaller than 1/2 of the radial dimension of the side 165, so that the area of the opening 161 is smaller, the edge of the opening 161 is convenient to fix, the membrane 160 is prevented from being damaged at the edge of the opening 161, the integrity of the membrane 160 is ensured, and the thrombus is convenient to block.

Preferably, the opening 161 is provided corresponding to the second connector 104, i.e. the second connector 104 is located in the opening 161. Generally, the second connector 104 is positioned at the geometric center of the distal end face 142, and the opening 161 is positioned in correspondence to the second connector 104 so that the anchoring skeleton 140 can be uniformly stressed in the circumferential direction.

Preferably, the bottom 162 forms the opening 161 by a melting or cutting process. For example, before the film body 160 is fixed to the support frame 101, an opening 161 is formed in the bottom 162, preferably in the geometric center of the bottom 162 by high-temperature melting or cutting. In some embodiments, the opening 161 may also be formed after being fixed to the surface of the support frame 101.

In the present embodiment, the membrane 160 covers the proximal surface and the circumferential side wall of the seal skeleton 120, so that the left atrial appendage is choked in the proximal side of the left atrial appendage occlusion device 100. Preferably, the membrane 160 has an opening formed at the proximal end corresponding to the first connector 103, and the opening is equal to the radial dimension of the first connector 103, so that the delivery device can be detachably connected to the first connector 103, and the sealing performance of the proximal end surface of the membrane 160 can be ensured.

Second embodiment

Referring to fig. 2A to 2C, fig. 2A is a schematic structural diagram of a left atrial appendage occlusion device 200 according to a second embodiment of the present application, fig. 2B is a schematic structural diagram of a supporting frame 201 in the left atrial appendage occlusion device 200 shown in fig. 2A, and fig. 2C is a schematic structural diagram of a membrane 260 in the left atrial appendage occlusion device 200 shown in fig. 2A.

The present embodiment provides a left atrial appendage occlusion device 200, where the left atrial appendage occlusion device 200 includes a sealing portion 210 and an anchoring portion 230 connected to each other, and a supporting frame 201 in the left atrial appendage occlusion device 200 includes a sealing frame 220 disposed on the sealing portion 210, and an anchoring frame 240 disposed on the anchoring portion 230. Please refer to the first embodiment for the similarity between the left atrial appendage occlusion device 200 and the left atrial appendage occlusion device 100, the differences between the left atrial appendage occlusion device 200 and the left atrial appendage occlusion device 100 are mainly described in the following.

In this embodiment, the left atrial appendage occlusion device 200 is provided with a membrane 260, the membrane 260 is coated on the surface of the anchoring skeleton 240, that is, the anchoring portion 230 includes the anchoring skeleton 240 and the membrane 260 covering the outer surface of the anchoring skeleton 240, the membrane 260 does not extend to the sealing portion 110, and the surface of the sealing skeleton 220 does not cover the membrane 260. In a modified embodiment, the membrane 260 may extend to the sealing portion 210, i.e., at least partially cover the surface of the sealing skeleton 220. In an alternative embodiment, at least one membrane may be disposed on the outer surface or in the inner cavity of the sealing portion 210 to achieve the effect of blocking flow.

As shown in fig. 2A to 2C, the opening 261 is preferably provided corresponding to the second connection member 204, that is, the second connection member 204 can be exposed on the surface of the anchor portion 230 through the opening 261. Generally, the second connecting member 204 is disposed in the geometric center of the distal end face 242, and the opening 261 is disposed corresponding to the second connecting member 204, so that the anchoring skeleton 240 is uniformly stressed in the circumferential direction, and the radial dimension of the second connecting member 204 after being radially compressed is reduced, thereby facilitating sheath retraction.

The membrane 260 provided on the surface of the anchor 230 serves to block thrombus from flowing out of the inside of the left atrial appendage, and accordingly, the opening 261 at the distal end of the membrane 260 is provided smaller with respect to the opening 161. Preferably, the opening 261 mates with the peripheral sidewall of the second connector 204. Preferably, the inner periphery 263 of the bottom 262 is abutted against the outer peripheral sidewall of the second connecting member 204, and the blood flow can pass through the gap between the inner periphery 263 and the outer peripheral sidewall of the second connecting member 204, and the gap is smaller, so that the thrombus is difficult to pass through, thereby ensuring the better flow blocking performance of the membrane 260.

In this embodiment, the supporting framework 201 is columnar, the proximal end and the distal end are both closed, the supporting framework 201 surrounds an inner cavity 202, the distal end of the supporting framework 201 forms a recess extending toward the proximal end of the supporting framework 201, and the recess structure is embodied at the distal end of the anchoring framework 240.

Specifically, the anchoring skeleton 240 includes a gathering section 241, the gathering section 241 extending in a funnel shape between the proximal and distal ends of the left atrial appendage occluder 200. The gathering section 241 is disposed radially inward of the sidewall 245, a proximal end of the gathering section 241 is connected to the second connector 204, and a distal end of the gathering section 241 is connected to the distal end face 242. The distal end of the gathering section 241 forms a larger opening than the proximal end of the gathering section 241, i.e., the gathering section 241 increases in radial dimension during the axial distal extension of the gathering section 241, with the flare formed by the gathering section 241 facing the distal side of the left atrial appendage occlusion device 200. The flared gathered section 241 forms the recess as seen proximally from the distal side of the left atrial appendage occlusion device 200.

The anchoring skeleton 240 is made by a braiding or cutting process, the plurality of support rods in the anchoring skeleton 240 may be a plurality of braided wires or a plurality of cutting rods in the anchoring skeleton 240, the support rods in the distal end face 242 are gathered in the gathering section 241, and the end parts of the support rods in the gathering section 241 are fixed to the second connecting piece 204. The second connecting member 204 may have a single-layered or multi-layered tubular structure, and the ends of the support rods in the gathering section 241 may be fixed between the multi-layered tubular structures of the second connecting member 204.

The supporting framework 201 surrounds the inner cavity 202, the sealing framework 220 surrounds the proximal periphery of the inner cavity 202, the anchoring framework 240 surrounds the distal periphery of the inner cavity 202, namely the gathering section 241, the distal end face 242 and the side wall 245 surround the inner cavity 202.

It should be noted that the above technical solution regarding the anchoring frame 201 and the technical solution of the second connecting member 204 may be applied to the first embodiment.

The bottom 262 covers at least a portion of the surface of the bunched segment 241 facing away from the lumen 202. The opening 261 formed by the bottom 262 has a smaller area, and the inner periphery 263 of the bottom 262 extends to the gathering section 241, which is beneficial to improving the flow blocking performance of the membrane 260.

Preferably, the inner periphery 263 of the bottom 262 abuts against the outer side surface of the bunching section 241 and extends in the proximal direction of the bunching section 241 such that a portion of the bottom 262 near its inner periphery abuts against a recessed surface formed by the bunching section 241, the bottom 262 correspondingly forming a recess extending in the proximal direction of the bunching section 241, i.e. the bottom 262 forming a recess extending in the proximal direction of the bunching section 241.

The inner periphery 263 of the bottom 262 is abutted against the outer side surface of the gathering section 241 and extends towards the proximal direction of the gathering section 241, and is concave in shape according to the gathering section 241, and does not cover the space pointed by the opening formed at the distal end of the gathering section 241, so that the gap between the bottom 262 and the anchoring skeleton is reduced or eliminated, and the membrane 260 has stronger deformation capability according to the gathering section 241. In particular, during sheath retraction and release of the bunching section 241, the inner periphery 263 of the bottom 262 is capable of uniformly radially compressing and expanding with the bunching section 241. After radial compression, the inner periphery 263 of the bottom 262 and the portion adjacent to the inner periphery 263 are less likely to be stacked together, and the radial dimension of the anchoring portion 230 varies less axially around, so that the radial dimension of the anchoring portion 230 after radial compression is controlled, and the sheath size in the delivery device is reduced.

The membrane 260 may be fixed to the surface of the support frame 201 by bonding, sewing, hot pressing, dipping, spraying, or the like. In the present embodiment, the membrane 260 is fixed by stitching, and the membrane 260 is stitched to the anchor skeleton 240 at the fixing point 272.

Both the bottom 262 and the side 265 of the membrane 260 may be connected to the anchoring skeleton 240. In this embodiment, as shown, the membrane 260 is provided with fastening points 272 at both the bottom 262 and the side 265.

The number of the fixing points 272 is plural, and the fixing points are disposed at least two axial positions of the membrane 260. The fixation points 272 located at the same axial position on the membrane body 260 are a set of fixation points 272, with at least two sets of fixation points 272 located at different axial positions of the membrane body 260. The number of fixing points 272 in each set of fixing points 272 may be set as required, and in this embodiment, the number of fixing points 272 in each set of fixing points 272 is plural, and the plurality of fixing points 272 in each set of fixing points 272 are arranged at intervals in the circumferential direction.

Preferably, the side 265 is provided with at least one set of fixation points 272. In this embodiment, the fixation point 272 on the side 265 is provided at the proximal edge of the side 265 to avoid the proximal edge of the side 265 from rolling distally of the left atrial appendage occlusion device 200.

Preferably, the bottom 262 is provided with at least one set of fixation points 272. In this embodiment, the fixed point 272 on the bottom 262 is disposed in the outer race region 260w.

The radius of the side portion 265 is R, the bottom portion 262 includes an inner ring region 260n and an outer ring region 260w, the inner ring region 260n is a circumferential range of the bottom portion 262 having a radius less than R/3, the outer ring region 260w is a circumferential range of the bottom portion 262 having a radius greater than or equal to R/3, and the bottom portion 262 is fixedly connected to the anchoring skeleton 240 within the outer ring region 260 w. The dashed line in fig. 2C schematically indicates the boundary position between the inner ring region 260n and the outer ring region 260 w.

The bottom 262 is provided with a fastening point 272 to facilitate fastening of the membrane 260 at the distal surface 242. The fixing points 272 in the bottom 262 are not arranged in the inner ring area 260n, so that the binding effect of the inner ring area 260n in the membrane 260 on the anchoring skeleton 240 is reduced, the deformation flexibility of the supporting rods in the anchoring skeleton 240 corresponding to the inner ring area 260n is improved, the anchoring skeleton 240 corresponding to the inner ring area 260n can be contracted to a smaller radial size in the radial compression process, and sheath retraction is facilitated.

It is understood that the membrane 260 may be secured in at least one of the gathering section 241, the distal surface 242, and the sidewall 245.

Referring to fig. 2D in conjunction with fig. 2C, fig. 2D is an enlarged schematic view of a region of fig. 2C in which an opening 261 is formed in a bottom 262.

Since the inner periphery 263 is formed by a process such as melting or cutting, in order to avoid the damage of the inner periphery 263 and affect the integrity of the membrane 260, and further affect the flow blocking performance of the membrane 260 and other related effects, preferably, the membrane 260 is provided with a reinforcement 280 on the inner periphery 263 of the bottom 262, the reinforcement 280 covers at least part of the inner periphery 263 to improve the mechanical strength of the inner periphery 263, and the mechanical strength of the inner periphery 263 covered by the reinforcement 280 is higher and is not easy to damage compared with the inner periphery 263 not covered by the reinforcement 280.

The inner periphery 263 in the embodiment of the present application includes an edge where the bottom 262 forms the opening 261, and a portion adjacent to the edge and extending along the edge in a radial direction in a direction away from the opening 261, and the inner periphery 263 covers a section in a radial and/or axial direction. In some embodiments, the edges of the inner periphery 263 are rounded.

The reinforcement 280 may cover the inner periphery 263 in at least one direction of the inner side and/or the outer side of the inner periphery 263. The inner side of the inner periphery 263 is the inner side of the bottom 262, which means that the inner periphery 263 and the bottom 262 face to one side of the anchoring frame 240; the outer side of the inner periphery 263, i.e., the outer side of the bottom 262, means the inner periphery 263 and the side of the bottom 262 facing away from the anchoring frame 240.

In some embodiments, the reinforcement 280 may be wrapped around the end face of the inner periphery 263 facing the opening 261, i.e., the end face of the inner periphery 263 in the thickness direction.

In this embodiment, at least a portion of the reinforcement 280 is sewn around the inner periphery 263 using a suture. In alternative embodiments, at least a portion of the reinforcement 280 may be formed of an organic material applied to the inner periphery 263, or the reinforcement 280 may include additional components attached to the inner periphery 263.

Referring to fig. 2E and 2F in conjunction with fig. 2D, fig. 2E and 2F are block diagrams illustrating steps of forming the fastener 280 in fig. 2D. Fig. 2E is a schematic structural view of the spacer 282 in fig. 2D, and fig. 2F is a schematic view of forming the edge seal 284 on the basis of fig. 2D. For clarity of illustration, in fig. 2D to 2F, the stitching lines formed outside the bottom portion 262 are indicated by thick solid lines, and the stitching lines formed inside the bottom portion 262 are indicated by thin solid lines.

Specifically, as shown in FIG. 2D, the reinforcement 280 includes a spacer 282 and a bead wire 284.

As shown in fig. 2D and 2E, the spacer 282 is disposed on the inner periphery 263 of the bottom 262, the inner periphery 263 of the spacer 282 corresponds to the opening 261 at the distal end of the membrane 260, and at least part of the inner periphery of the spacer 282 may be coincident with the inner periphery 263 of the bottom 262 or disposed radially outside the inner periphery 263 of the bottom 262, i.e., the spacer 282 is at least partially disposed on the bottom 262. The spacer 282 may be disposed inboard and/or outboard of the inner periphery 263.

Preferably, the spacer 282 is disposed along the inner periphery 263, shaped to fit the inner periphery 263. In the present embodiment, the spacer 282 is provided on the inner periphery 263 for one revolution. In some embodiments, the spacer 282 may be provided in a partial arc shape.

The spacer 282 is formed in the region of the base 262 adjacent the edge of its inner periphery 263 to ensure that both the inner periphery and the outer periphery of the spacer 282 are radially offset from the inner periphery 263 of the base 262. In the present embodiment, the outer periphery of the spacer 282 is disposed outside the inner periphery 263 of the bottom 262 in the radial direction of the bottom 262, and the radial dimension of the inner periphery of the spacer 282 is larger than the radial dimension of the inner periphery 263 of the bottom 262 at the same circumferential position, and the spacer 282 is disposed on the radial periphery of the inner periphery 263.

The spacer 282 may be formed of a biocompatible, resilient polymeric wire or sheet material so as to be deformable with the membrane 260.

In this embodiment, the spacer 282 is a length of suture sewn to the inner periphery 263 of the bottom 262. The stitching lines forming the spacers 282 are stitched starting from a position near the edge of the inner periphery 263, and are threaded back and forth between the inside and outside of the bottom 262 during stitching along the inner periphery 263, with a portion of the stitching lines being located on the outside surface of the bottom 262 (the side facing away from the lumen, shown in bold lines) and a portion of the stitching lines being located on the inside surface of the bottom 262 (the side facing toward the lumen, shown in bold lines). The suture forming the spacer 282 may be stitched one revolution, more than one revolution, or less than one revolution along the inner periphery 263.

As shown in fig. 2F, fig. 2F is a schematic view of a structure of a part of the edge-sealing line 284 formed by sewing on the basis of the spacer 282, and fig. 2F is a schematic view of the edge-sealing line 284 sewn to a 1/4 circumferential extent during the process of sewing the edge-sealing line 284 for clarity of illustration.

The edge-sealing line 284 may cover at least a part of the inner periphery 263, in this embodiment, the edge-sealing line 284 is formed by winding a suture between the radially outer side of the outer periphery of the spacer 282 and the opening 261.

The bead 284 is threaded back and forth inside and outside the inner periphery 263 during the formation process, specifically, the bead 284 is threaded through the bottom 262 from one side of the inner periphery 263 to the other side, and the position of the threaded bottom 262 is located radially outside the outer periphery of the spacer 282.

In the present embodiment, the edge seal 284 is sewn starting from a position radially outward of the outer periphery of the spacer 282, and a knot 285 is formed, the knot 285 being used to be fixed to the inner periphery 263. The seal line 284 penetrates the bottom 262 from the radially outer side thereof to the radially inner side thereof, the position of the penetration bottom 262 being located radially outer of the outer periphery of the spacer 282, and then penetrates out to the outer side of the inner periphery 263 from the radially inner side of the inner periphery 263 through the opening 261 to the radially outer side of the inner periphery 263; the bottom 262 is inserted from the radially outer side of the inner periphery 263 to the radially inner side, the position of the inserted bottom 262 is located at the radially outer side of the outer periphery of the spacer 282, and then the bottom is inserted from the radially inner side of the inner periphery 263 to the radially outer side of the inner periphery 263 through the opening 261. The method is repeated to form a bead line 284 circumferentially around the inner periphery 263 that covers at least a portion of the surface of the inner periphery 263.

The edge sealing line 284 is used to cover the inner periphery 263, so as to improve the structural strength of the inner periphery 263. The edge sealing line 284 is penetrated back and forth in the thickness direction of the bottom 262, one end of the edge sealing line 284 is positioned in the opening 261 in the radial direction of the bottom 262, the other end of the edge sealing line 284 is positioned at the radial outer side of the outer periphery of the spacer 282, the outer periphery of the spacer 282 is used for fixing the radial end position of the edge sealing line 284, the structural reliability of the edge sealing line 284 is improved, serious deformation of fibers in the material of the film body 260 under the traction action of the edge sealing line 284 is avoided, and the damage of the inner periphery 263 caused by the sewing of the edge sealing line 284 is avoided.

Referring to fig. 2G, in some modified embodiments, the spacer is omitted from the reinforcement 280, i.e., only the edge seal 284 is included in the reinforcement 280.

It will be appreciated that the method of forming the reinforcement 280 is provided in this embodiment, and that in other embodiments, the reinforcement 280 may be formed in other ways.

The present embodiment provides a specific technical solution, such as the technical solution of the fixing point 272 and the technical solution of the reinforcement 280, and can be applied to other embodiments without contradiction, which is not described herein.

Third embodiment

Referring to fig. 3A, 3B and 3C, fig. 3A is a schematic structural view of a left atrial appendage occlusion device 300 according to a third embodiment of the present application, fig. 3B is a schematic structural view of the left atrial appendage occlusion device 300 in fig. 3A at another angle, fig. 3C is a schematic sectional structural view of the left atrial appendage occlusion device 300 in fig. 3B, and fig. 3C is a sectional view of the left atrial appendage occlusion device 300 in fig. 3A along a plane passing through an axis thereof.

The present embodiment provides a left atrial appendage occlusion device 300, where the left atrial appendage occlusion device 300 includes a sealing portion 310 and an anchoring portion 330 connected to each other, and a supporting frame 301 in the left atrial appendage occlusion device 300 includes a sealing frame 320 disposed on the sealing portion 310, and an anchoring frame 340 disposed on the anchoring portion 330. Please refer to the first embodiment for the similarity between the left atrial appendage occlusion device 300 and the left atrial appendage occlusion device 100, the differences between the left atrial appendage occlusion device 300 and the left atrial appendage occlusion device 100 are mainly described in the following.

In this embodiment, the sealing portion 310 and the anchoring portion 330 are of a split structure, the left atrial appendage sealer 300 includes a fixing member 305, the fixing member 305 is connected between the sealing portion 310 and the anchoring portion 330, and further, the sealing skeleton 320 and the anchoring skeleton 340 are connected by the fixing member 305. Specifically, the securing member 305 is connected between the distal portion of the sealing skeleton 320 and the proximal end of the gathering section 341.

The fixing member 305 may be a single-layer or multi-layer tubular structure, the proximal end of the gathering section 341 of the anchoring skeleton 340 is connected to the fixing member 305, the supporting rod in the anchoring skeleton 340 may be a braided wire or a cutting rod, and the end of the supporting rod is combined and fixed to the fixing member 305, for example, may be sandwiched between the multi-layer tubular structures in the fixing member 305. The proximal end of the gathering section 341 may be welded to the anchor 305.

In some embodiments, the distal end of the seal housing 320 may be secured to the securing member 305, in this embodiment, the distal portion of the seal housing 320 includes the distal end of the seal housing 320 and a portion of the seal housing 320 that is coupled to the distal end thereof. In some embodiments, the anchoring framework 340 is plunger-like and the proximal end of the anchoring framework 340 may be secured to the anchor 305.

In this embodiment, as shown in fig. 3C, the gathering section 341 is flared and radially inward thereof encloses a flare, and the proximal end of the sidewall 345 is a free end and forms an opening proximal to the anchoring frame 340. The converging section 341, distal face 342, and sidewall 345 define a lumen that opens toward the proximal end of the left atrial appendage occlusion device 300.

The distal portion of the seal skeleton 320 is gathered to the fixing member 305, and the distal end of the seal skeleton 320 passes through the fixing member 305, passes through the radially inner side of the gathering section 341, i.e., passes through the flare formed by the radially inner side of the gathering section 341, and extends from the distal direction of the flare formed by the gathering section 341. The fixing member 305 is disposed radially outward of the proximal end of the gathering section 341, that is, the fixing member 305 is sleeved radially outward of the proximal end of the gathering section 341 and radially outward of the distal portion of the seal skeleton 320.

As shown in fig. 3C, in the present embodiment, the second connecting member 304 is sleeved on the outer side of the distal end of the seal frame 320, and the end portion of the support rod at the distal end of the seal frame 320 is combined with one portion and fixed to the second connecting member 304. The second connector 304 may be a single-layer or multi-layer tubular structure, and optionally, the ends of the support rods in the seal housing 320 are welded to the distal ends of the second connector 304.

At least a portion of the second connector 304 is located in a space (specifically, a flare) defined radially inward of the gathering section 341, the distal end of the second connector being axially spaced from the distal end of the base 362 by a distance of between-2, 2 mm. That is, the distal end of the second connector 304 extends [0,2] mm beyond the distal end of the base 362 in the proximal-to-distal direction, i.e., the distal end of the second connector 304 protrudes [0,2] mm distally relative to the distal end of the base 362; or the distal end of the second connector 304 exceeds the distal end of the base 362 by 0,2 mm in a distal-to-proximal direction, i.e., the distal end of the second connector 304 is recessed proximally by 0,2 mm relative to the distal end of the base 362. Thereby ensuring that the second connector 304 is substantially flush with the distal end of the base 362, facilitating the welding of the distal end of the seal housing 320 to the second connector 304. In this embodiment, the distal end of the second connector 304 is recessed [0,2] mm proximally relative to the distal end of the base 362, covered by the membrane body 360.

The axial distance between the proximal end of the fixing element 305 and the distal end of the anchoring portion 330 is a, the axial distance between the proximal end of the peripheral surface of the anchoring portion 330 and the distal end of the anchoring portion is b, alternatively, a is less than or equal to 0.8b, the fixing element 305 is accommodated in the inner cavity surrounded by the anchoring portion 330, which is beneficial to reducing the axial length of the anchoring portion 330, the distal portion of the sealing portion 310 can be accommodated in the space surrounded by the anchoring portion 330, the fixing element 305 is accommodated in the inner cavity surrounded by the anchoring portion 330, and the fixing element 305 is arranged at the proximal end of the anchoring portion 330 relative to the fixing element 305, and is closer to the distal end surface 342, which can improve the radial supporting force of the distal end surface 342 of the anchoring skeleton 340, and can also accommodate at least part of the sealing portion 310 in the inner cavity, which reduces the axial dimension of the left atrial appendage occluder 300 after the sealing portion 310 and the anchoring portion 330 are assembled, thereby avoiding the situation that the peripheral edge of the sealing portion 310 cannot be sealed at the left atrial appendage portion due to the axial length of the left atrial appendage occluder 300 being too long.

Preferably, a is less than or equal to 0.3b and less than or equal to 0.7b, so that the distal end face 342 can obtain proper radial supporting force, the gathering section 341 does not generate particularly obvious stress concentration phenomenon in the process of mutually switching the left atrial appendage occlusion device 300 between the natural state and the delivery state, and meanwhile, the length of the left atrial appendage occlusion device 300 is ensured to be shorter, so that the left atrial appendage occlusion device can be suitable for patients with shorter left atrial appendage inner cavities.

In this embodiment, the anchoring portion 330 has an opening formed at a proximal end thereof in a proximal direction, and in some embodiments, the anchoring portion 330 may be in a form that is closed at both a proximal end and a distal end, for example, the fixing member 305 is used to connect to the proximal end of the anchoring portion 330, the second connecting member 304 is connected to the distal end of the anchoring portion 330, and the second connecting member 304 may be disposed at the distal end of the anchoring portion 330 or disposed in a cavity enclosed by the anchoring portion 330.

In the present embodiment, the bottom 362 has a plurality of openings 361 formed therein, and the openings are provided at intervals in the bottom 362. The plurality of openings 361 formed in the bottom 362 are beneficial to keeping blood on two sides of the bottom 362 to circulate, so that excessive blood pressure in the inner cavity of the left auricle in the process of releasing the left auricle occluder is avoided, and resistance in the process of releasing the left auricle is reduced.

It will be appreciated that in alternative embodiments, the opening 361 may take the form provided by the first and second embodiments.

In this embodiment, the cross section of the seal skeleton 320 is trapezoidal, that is, the seal skeleton 320 has a certain thickness in the axial direction, the seal portion 310 is provided with a plurality of flow blocking films 321 at different axial positions in the inner cavity of the seal skeleton 320, specifically, a piece of flow blocking film 321 is respectively provided at the inner side, the distal side, and the middle part in the inner cavity of the seal skeleton 320. It is understood that in the modified embodiment, the shape of the seal frame 320, the number and positions of the flow blocking films 321 provided on the seal frame 320 may be set as needed.

Referring to fig. 3D, in some modified embodiments, the membrane body 360 is further provided with an opening corresponding to the second connecting member 304 provided in the second embodiment based on the technical solution of fig. 3A, so that the second connecting member 304 can be exposed from the distal end of the membrane body 360 through the opening.

Fourth embodiment

Referring to fig. 4A to 4C, fig. 4A is a schematic structural view of a left atrial appendage occlusion device 400 according to a fourth embodiment of the present application, fig. 4B is a schematic structural view of the left atrial appendage occlusion device 400 in fig. 4A, specifically, fig. 4B is a cross-sectional view of the left atrial appendage occlusion device 400 in fig. 4A along a plane passing through an axial direction thereof, fig. 4C is a schematic partial structural view of the left atrial appendage occlusion device 400 in fig. 4A, fig. 4C shows a specific structure related to a pulling wire 490, fig. 4C shows a structure of a portion of a membrane 460 for forming an opening 461, a partial structure of a supporting skeleton, and a partial structure of a sealing skeleton 420, and the structures of an anchoring skeleton 440, a second connector 404 and the like are omitted for clarity; fig. 4D is a schematic structural view of the pull wire 490 of fig. 4C during formation, specifically, the suture of fig. 4D forms a fixed section and a pull section; fig. 4E is a schematic view illustrating another angle between the membrane 460 and the pulling wire 490 in fig. 4A.

The present embodiment provides a left atrial appendage occlusion device 400, where the left atrial appendage occlusion device 400 includes a sealing portion 410 and an anchoring portion 430 connected to each other, and a support frame 401 in the left atrial appendage occlusion device 400 includes a sealing frame 420 disposed on the sealing portion 410, and an anchoring frame 440 disposed on the anchoring portion 430. Please refer to the third embodiment for the similarity between the left atrial appendage occlusion device 400 and the left atrial appendage occlusion device 300, the differences between the left atrial appendage occlusion device 400 and the left atrial appendage occlusion device 300 are mainly described in the following.

As shown in fig. 4C, the left atrial appendage occlusion device 400 includes a pull wire 490 connected to the inner periphery 463 of the base 462 and the sealing portion 410. The pulling wire 490 is used for fixing the inner periphery 463 of the bottom 462, the pulling wire 490 is connected to the sealing portion 410, which is favorable for pulling and fixing the inner periphery 463 from the proximal side of the inner periphery 463, so that the inner periphery 463 can correspondingly cover and attach to the outer side surface (the surface deviating from the inner cavity) of the anchoring framework 440, in this embodiment, the periphery 463 can correspondingly cover and attach to the outer side surface of the gathering section 441, and forms a recess extending towards the direction of the sealing portion 410, so that the membrane 460 has stronger capability of conforming to the deformation of the gathering section 441, the inner periphery 463 of the bottom 462 can be uniformly compressed and expanded radially along with the gathering section 441 in the process of gathering and releasing the gathering section 441, after the inner periphery 463 of the bottom 462 is compressed radially, the inner periphery 463 of the bottom 462 cannot be stacked at one place, the radial dimensional change of the axial position of the anchoring section 430 is relatively small, and the radial dimensional change of the anchoring section 430 after radial compression is convenient to control is reduced, and the sheath size in the conveying device is reduced.

Adjacent support rods in the sealing skeleton 320 are connected to each other and form mesh openings, and the sealing skeleton 320 may be made by weaving and/or cutting processes, and the mesh openings may be mesh openings formed between woven wires in the sealing skeleton 320 or mesh openings surrounded between the cutting rods.

The number of the pulling wires 490 in the left atrial appendage occlusion device 400 may be one or more, and in this embodiment, the number of the pulling wires 490 is one.

The pull wire 490 includes a pull segment 491 and a securing segment 493 connected to each other, the securing segment 493 being adapted to be sewn to the inner periphery 463 of the base 462, at least one end of the pull segment 491 being connected to the securing segment 493, the pull segment 491 extending proximally of the securing segment 493, a portion of the pull segment 491 being connected to the mesh of the sealing skeleton 420.

In this embodiment, the pull wire 490 is a suture and includes two fixed segments 493 and one pull segment 491. Two ends of the pulling section 491 are respectively connected with a fixing section 493. While the fixing segment 493 is used to stitch the inner periphery 463 of the bottom 462, in this embodiment, the fixing segment 493 is stitched to the inner periphery 463 by knotting, it is to be understood that the fixing segment 493 is not limited to stitching to the inner periphery 463 by knotting, and the fixing segment 493 may be connected to the inner periphery 463 by stitching such as inserting stitching between the inner side (side facing the inner cavity) and the outer side (side facing the inner cavity) of the inner periphery.

At least one end of the pulling segment 491 is connected to the fixed segment 493, and the pulling segment 491 extends proximally of the fixed segment 493. In the present embodiment, both ends of the pulling segment 491 are connected to the fixed segment 493, the pulling segment 491 forms a wire loop and extends proximally of the fixed segment 493, and the pulling segment 491 extends proximally of the fixed segment 493 from the fixed segment 493.

A portion of the pulling segment 491 is connected to the mesh of the sealing skeleton 420, which may be specifically shown in fig. 4C, and a portion between both ends of the pulling segment 491 passes through the mesh formed by the support rods in the sealing skeleton 420.

If the mesh of the sealing skeleton 420 through which the pulling segment 491 passes is made by a cutting process, the support rods forming the mesh do not slide relatively, the size and position of the mesh are relatively fixed, and the pulling segment 491 can better realize the function of fixing the inner periphery 463 through the mesh.

In this embodiment, the sealing skeleton 420 is made by a braiding process, that is, the mesh of the sealing skeleton 420 through which the pulling segment 491 passes is made by a braiding process, the pulling segment 491 is easy to slide relatively between the support rods of the mesh, and the size and position of the mesh hole are not fixed.

The radially outer side of the distal portion of the seal case 420 is provided with a fixing member 405, further the distal portion of the seal case 420 is narrowed radially inwardly of the fixing member 405, a pulling segment 491 is passed through a mesh of the seal case 420 located proximally of the fixing member 405 and near the proximal end of the fixing member 405, the proximal end of the fixing member 405 is used to stop the portion of the pulling segment 491 passing through the meshes of the two seal cases 420 distally, i.e. the proximal end of the fixing member 305 is used to stop the distal end of the pulling segment 491 distally. The distal end of the pulling segment 491 herein refers to a portion of the pulling segment 491 connected (in this embodiment, specifically penetrated) to the mesh of the sealing portion 420 as in fig. 4C, and is located at the most distal end of the pulling segment 491, and is not limited to one of the two ends of the suture forming the pulling segment 491.

It should be noted that, the mesh of the sealing skeleton 420 through which the pulling wire 490 passes is located at the proximal side of the fixing member 405, the fixing member 405 is used for converging the end of the anchoring skeleton 440, the radial dimension thereof is smaller, the distal portion of the sealing skeleton 420 is threaded through and converged at the radial inner side of the fixing member 405, and the radial inner side of the converging section 441 in the anchoring skeleton 440, and the distal end of the sealing skeleton 420 is converged and fixed to the second connecting member 404. After the instrument is released, even if the support rod of the sealing skeleton 420 at the fixing member 405 and its distal portion is formed with a mesh, the mesh cannot be unfolded, and the difficulty of pulling the segment 491 through the mesh at this position is great.

The distal end of the pulling segment 491 does not slide far away from the proximal end of the fixing member 405 even if it slides to the anchor 430 side along the support rod in the sealing skeleton 420 or slides to the anchor 430 side along with the deformation of the mesh in the mesh of the sealing skeleton 420, and a part of the pulling segment 491 is connected to the mesh of the sealing skeleton 420, so that the fixing member 405 can play a role of limiting the end of the pulling segment 491, that is, the distal end position of the pulling segment 491 is fixed, thereby playing a role of preferably fixing the inner periphery 463 of the bottom 462, without limiting the manufacturing process of the sealing skeleton 420.

As shown in fig. 4C, the pulling segment 491 passes through two meshes in the sealing skeleton 420, and the pulling segment 491 located between the two meshes spans the fixing member 405.

Referring to fig. 4D and 4E in conjunction with fig. 4C, at least a portion of the supporting frame and at least a portion of the connecting members are omitted from fig. 4C, 4D and 4E for clarity. Both fig. 4D and 4E do not show the attachment points 472, it being understood that at least a portion of the attachment points 472 may be attached prior to forming the pull wire 490 or, as shown in fig. 4E, the surface of the film body 460 may not be formed with any attachment points 472 prior to stitching to form the pull wire 490.

Specifically, during the suturing process, as shown in fig. 4C, 4D and 4E, a fixing section 493 is formed by suturing the inner periphery 463, then the suture is pulled proximally to form a pulling section 491, the suture is led to extend to the proximal end of the auricle occluder 400 after passing through the mesh formed by the anchoring frame 440, the suture line forming the pulling section 491 passes through the two meshes of the sealing frame 420 near the fixing member 405, the portion between the two meshes of the sealing frame 420 passing through the suture line forming the pulling section 491 is located near the fixing member 405, the suture line forming the pulling section 491 passes through the fixing member 405 distally, the suture line forming the pulling section 491 passes through the two meshes of the sealing frame 420 and then extends to the distal end direction of the auricle occluder 400, then, as shown in fig. 4E, the pulling wire 490 is pulled tightly and the inner periphery 463 is sutured to form another fixing section 493, and the inner periphery 463 forms a recess extending to the proximal end of the membrane 460.

The pull wire 490 is sutured in a fully expanded state (natural state) of the support frame, after the two securing segments 493 are formed, the two proximal ends (securing segments 493) of the pull wire 490 are secured to the inner peripheral edge 463, the distal end of the pull wire 490 spans the proximal side of the securing member 405, is distally restrained by the securing member 405, and the pull wire 490 is tensioned. Under the pulling action of the pulling wire 490, the bottom 462 is flatly attached to the distal end surface and the surface of the gathering section, extends toward the proximal side of the gathering section 441, and forms a recess corresponding to the gathering section 441.

In this embodiment, the portion of the pulling segment 491 that connects to the securing segment 493 extends from the side of the base 462 facing away from the anchoring backbone 440 toward the proximal end of the left atrial appendage occlusion device 400 and through the opening 461. The inner peripheral edge 463 is sandwiched between the pulling segment 491 and the gathering segment 441, the pulling segment 491 extends proximally from the inner peripheral edge 463 surface and pulls the inner peripheral edge 463 so that the inner peripheral edge 463 can be flatly attached to the outer side surface of the gathering segment 441, avoiding the inner peripheral edge 463 from tilting.

In an alternative embodiment, the pulling wire 490 may include a fixing segment 493 and a pulling segment 491 that are connected to each other, wherein the fixing of the fixing segment 493 is stitched to the inner peripheral edge 463, and one end of the pulling segment 491 may be connected to an intersection point formed between support rods in the sealing skeleton 420 by winding and knotting, etc., so as to pull the inner peripheral edge 463 in the proximal direction.

Preferably, as shown in fig. 4A, the surface of the membrane body 460 is provided with a plurality of fixing points 472 as provided in the second embodiment. Preferably, the fixing point 472 is disposed in the outer ring area of the membrane 460 and is matched with the pulling wire 490, so that the bottom 462 can be fixed at the inner periphery 463 of the bottom 462 and the area of the bottom 462 away from the inner periphery 463, thereby improving the structural stability of the membrane 460 and ensuring the flexibility of the sheath retraction of the anchoring portion 430.

It should be noted that, in some embodiments, it is preferable that the film body 260 in the present embodiment may be provided with the reinforcement member in the second embodiment, and the pulling wire 490 may be fixed on the surface of the reinforcement member or disposed radially outside the reinforcement member, so as to improve the structural stability of the inner peripheral edge 463, and avoid the damage of the inner peripheral edge 463 during the sewing process of the pulling wire 490 or under the pulling action of the pulling wire 490, which affects the integrity and the safety and reliability of the film body 460.

Fifth embodiment

Referring to fig. 5A and fig. 5B, fig. 5A is a schematic structural diagram of a film body 560 according to another alternative embodiment of the present application; fig. 5B is an enlarged schematic view of the V region in fig. 5A.

In this embodiment, a membrane body 560 in a left atrial appendage occlusion device is provided, and the membrane body 560 can be applied to the left atrial appendage occlusion devices provided in the third and fourth embodiments, that is, the membrane body 560 can be used to replace the membrane body 360 on the surface of the supporting frame 301 or replace the membrane body 460 on the surface of the supporting frame 401. The main differences between the film body 560 and the film body 460 provided in this embodiment are as follows.

In this embodiment, the film body 560 is provided with a fixing point 572, and the specific structure of the fixing point 572 can refer to the fixing point 272 in the second embodiment, which is not described herein.

In this embodiment, the inner periphery 563 of the bottom 562 of the film body 560 is provided with a reinforcement 580, and the reinforcement 280 in the second embodiment is referred to for the specific structure of the reinforcement 580, which is not described here.

In this embodiment, the film body 560 is provided with a pull wire 590, and the pull wire 590 includes a fixing section 593 and a pull section 591.

In the process, the reinforcement 580 is formed on the inner peripheral edge 563, and then the pull wire 590 is formed by stitching on the inner peripheral edge 563. The fixing section 593 of the pull wire 590 may be located at the outer side of the reinforcement 580 in the radial direction of the bottom 562, or the fixing section 593 may be formed at a position where the reinforcement 580 is located, specifically, for example, after the reinforcement 580 is formed, the pull wire 590 may be directly sewn at the radial outer side of the reinforcement 580, or at a sewing position of the reinforcement 580.

The fixing step of the fixing point 572 of the bottom 562 in the outer ring region may be performed before the formation of the reinforcement 580 and the pulling wire 590, or after the formation of the reinforcement 580 and the pulling wire 590, or between the formation of the reinforcement 580 and the pulling wire 590, for example, after the formation of the reinforcement 580, the fixing point 572 may be further provided for fixing, and then the pulling wire 590 may be manufactured.

As shown in fig. 5B, in this embodiment, the pull wire 590 includes a plurality of fixing sections 593 and a plurality of pull sections 591, in this embodiment, each pull section 591 is used for penetrating two meshes in the sealing skeleton, and one end of each pull section 591 is connected to one fixing section 593 respectively.

Specifically, the pulling wire 590 includes 4 fixing segments 593 spaced circumferentially, which are respectively a fixing segment 593a, a fixing segment 593b, a fixing segment 593c, and a fixing segment 593d, and each fixing segment 593 is stitched to the inner peripheral edge 563, which may be understood as a connection portion formed by the inner peripheral edge 563 in the pulling wire 590, and in this embodiment, the connection portion is a stitching point.

A plurality of securing segments 593 may be formed sequentially on inner peripheral edge 563, such as first forming securing segments 593a on inner peripheral edge 563 and forming knots for securing. The pulling segment 591 (not shown) to which the securing segment 593a is attached extends proximally through two oppositely disposed mesh openings of the sealing skeleton and then out of the inner periphery 563 from the inside (the side facing the lumen) to the outside (the side facing away from the lumen) to form the securing segment 593c.

In the present embodiment, two meshes penetrating the seal frame in the pulling section 591 are provided opposite to each other, that is, the two meshes are spaced 180 degrees apart in the circumferential direction, and in the modified embodiment, the two meshes are not limited to the relationship of being provided opposite to each other, and the positions of the two meshes shifted in the axial direction and/or the circumferential direction may be set as needed.

One end of the fixing segment 593c extends into the opening 561 and proximally to form another pulling segment 591a, and the pulling segment 591a penetrates through the first sealing skeleton mesh position, and can be staggered from the fixing segment 593c by 90 degrees in the circumferential direction (such as axially below the fixing segment 593d in fig. 5B), so that the pulling segment 591 and the fixing segment 593 can be formed at a plurality of positions in the circumferential direction. That is, in the natural state of the left atrial appendage occlusion device 500, the proximal end and the distal end of at least one pulling segment 591 are offset from each other in the circumferential direction of the left atrial appendage occlusion device 500 in the plurality of pulling segments 591, and preferably, the proximal end and the distal end of the at least one pulling segment 591 are offset in the circumferential direction by an angle ranging from 60 degrees to 130 degrees.

As shown in fig. 5B, preferably, the pulling wire 591a passing through the opening 561 extends distally through the opposed two mesh openings of the sealing skeleton, passes through the inner peripheral edge 563 to form a securing segment 593B, and then proximally directs the suture in the same manner to form another pulling segment 591B, passes through the opposed two mesh openings of the sealing skeleton, extends distally through the inner peripheral edge 563 to form a securing segment 593d.

In the present embodiment, the fixing section 593 is formed in the order of the fixing section 593a, the fixing section 593c, the fixing section 593b, and the fixing section 593d, and in the forming process of the fixing section 593, the pulling section 591 connected to the fixing section 593 is formed correspondingly. In the present embodiment, the plurality of fixing segments 593 are arranged at regular intervals in the circumferential direction of the inner peripheral edge 563, that is, any circumferentially adjacent two fixing segments 593 are spaced at 90 degrees in the circumferential direction of the inner peripheral edge 563.

In the modified embodiment, the order of forming the plurality of fixing segments 593 may be set as needed, and is not limited to the order of forming the fixing segments 593 in the present embodiment. In a modified embodiment, the number of the fixing segments 593 and the pulling segments 591, and the intervals between adjacent fixing segments 593 may be set as desired.

In this embodiment, at least one of the plurality of pull segments 591 of the pull wire 590 extends proximally of the membrane body 560 through the opening 561, outside of the inner peripheral edge 563 (the side facing away from the lumen). Preferably, of the plurality of pull segments 591 in the pull wire 590, more than one pull segment 591 extends proximally of the membrane body 560 through the opening 561 outside of the inner peripheral edge 563. In this embodiment, the pull segments 591 passing through the openings 561 are formed by pulling the suture of the pull wire 590 in a distal-to-proximal direction, and in a modified embodiment, each pull segment 591 passing through the openings 561 may be formed by pulling the suture of the pull wire 590 in a distal-to-proximal direction, or in a proximal-to-distal direction.

Preferably, the initial portion of the pull wire 590 is provided with a knot, i.e. the fixing segment 593a is formed with a knot, and the fixing segment 593d is connected with the fixing segment 593a, so as to fix the tail portion of the pull wire 590 to the fixing segment 593a. In some modified embodiments, the securing segment 593d and the securing segment 593a are formed with a knot, respectively, and the securing segment 593d need not extend and connect to the securing segment 593a outside of the inner periphery 563 (the side facing away from the lumen).

It will be appreciated that in this embodiment, a knot may be provided in any one of the securing segments 593 for the purpose of securing the securing segment 593 to the inner periphery 563.

It is understood that in the present embodiment, a plurality of fixing segments 593 and a plurality of pulling segments 591 are formed in one pulling wire 590. The structure provided in this embodiment mode can be formed by providing a plurality of pull wires 590. It should be noted that, the various specific solutions in the above embodiments of the present application may be arbitrarily combined with each other, for example, the solutions provided in the respective embodiments, such as the supporting frame, the film body, the bottom opening, the fixing point, the reinforcement, the pulling line, etc., and, without contradiction, the solutions obtained by arbitrarily combining with each other also belong to the protection scope of the present application, for example, the pulling line 590 in the fifth embodiment may be applied to the fourth embodiment instead of the pulling line 490, and the reinforcement 580 in the present embodiment may be applied to the embodiment in fig. 3D and the fourth embodiment.

The present application is not limited to the above embodiments, and any changes or substitutions that can be easily understood by those skilled in the art within the technical scope of the present application are intended to be included in the scope of the present application. Therefore, the protection scope of the application is subject to the protection scope of the claims.

Claims

1. The utility model provides a left auricle plugging device which characterized in that, includes sealing portion and anchoring portion, sealing portion sets up in the proximal side of anchoring portion, the anchoring portion include the anchor skeleton and cover in the membrane body of anchor skeleton surface, the anchor skeleton includes distal end face and lateral wall, the lateral wall with the distal end face is connected, the membrane body covers at least part the lateral wall, and with the periphery that the lateral wall is connected in the distal end face, the membrane body is provided with the opening in the outside of distal end face.

2. The left atrial appendage occlusion device of claim 1, wherein said membrane comprises a side portion for covering an outer side of said sidewall and a bottom portion for covering a periphery of said distal surface connected to said sidewall, an inner periphery of said bottom portion surrounding said opening.

3. The left atrial appendage occlusion device of claim 2, wherein said distal end is planar or arcuate and said bottom inner diameter is less than or equal to 1/2 of a radial dimension of said sidewall.

4. The left atrial appendage occlusion device of claim 3, wherein the left atrial appendage occlusion device comprises a support skeleton comprising the seal skeleton and the anchor skeleton disposed distally of the seal skeleton, each of the seal skeleton and the anchor skeleton comprising a plurality of support rods, adjacent support rods interconnected to form the seal skeleton and the anchor skeleton, the left atrial appendage occlusion device comprising a second connector disposed at a distal portion of the support skeleton for constricting ends of the seal skeleton or the plurality of support rods in the anchor skeleton.

5. The left atrial appendage occlusion device of claim 4, wherein at least a portion of said second connector is exposed distally of said anchoring framework, said opening being disposed in correspondence of said second connector, an inner periphery of said base being disposed against an outer peripheral sidewall of said second connector.

6. The left atrial appendage occlusion device of claim 4, wherein said anchoring skeleton comprises a gathering section, said gathering section being funnel-shaped and disposed radially inward of said sidewall, a distal end of said gathering section being connected to said distal end surface, a support rod in said distal end surface converging in said gathering section, said distal end surface and said sidewall surrounding an interior cavity, said bottom covering at least a portion of a surface of said gathering section facing away from said interior cavity.

7. The left atrial appendage occlusion device of claim 6, wherein an inner peripheral edge of said base abuts an outer side surface of said gathering section and extends in a proximal direction of said gathering section such that a portion of said base proximate to an inner peripheral edge thereof forms a recess extending in a proximal direction of said gathering section.

8. The left atrial appendage occlusion device of claim 6, wherein said side portion has a radius R, said base portion comprises an inner ring region and an outer ring region, said inner ring region being a circumferential extent of said base portion having a radius less than R/3, said outer ring region being a circumferential extent of said base portion having a radius greater than or equal to R/3;

the bottom is fixedly connected with the anchoring skeleton in the outer ring area.

9. The left atrial appendage occlusion device of any one of claim 4 to 8,

The sealing part and the anchoring part are of a split structure, and the left atrial appendage occlusion device comprises a fixing piece which is connected between the distal end of the sealing skeleton and the anchoring skeleton;

the left atrial appendage occlusion device comprises a traction wire connected to the inner periphery of the bottom and the sealing portion.

10. The left atrial appendage occlusion device of claim 9, wherein adjacent struts in said sealing skeleton are interconnected and form mesh openings;

The traction wire comprises a traction section and a fixing section which are connected with each other, wherein the fixing section is used for being sewn on the inner periphery of the bottom, at least one end part of the traction section is connected with the fixing section, the traction section extends to the proximal side of the fixing section, and one part of the traction section is connected with the mesh.

11. The left atrial appendage occlusion device of claim 10 wherein,

The number of the fixing sections is multiple, two ends of the pulling section are connected with different fixing sections, the pulling section penetrates through two meshes in the sealing framework, the distal part of the sealing framework is converged in the fixing piece, and the fixing piece is used for stopping the part of the pulling section penetrating through the two meshes distally.

12. The left atrial appendage occlusion device of claim 10 wherein,

The portion of the pulling segment that connects to the securing segment extends from a side of the base that faces away from the anchoring backbone to a proximal direction of the left atrial appendage occlusion device and through the opening.

13. The left atrial appendage occlusion device of claim 10 wherein,

The pull Duan Gu is defined at the intersection point formed between the support bars at the periphery of the mesh.

14. The left atrial appendage occlusion device of claim 9, wherein said membrane body is provided with a reinforcement at said inner periphery of said base, said reinforcement coating at least a portion of said inner periphery.

15. The left atrial appendage occlusion device of claim 14, wherein said reinforcement comprises a spacer and an edge line, said spacer being annularly disposed on said inner periphery of said base, said spacer having an inner periphery corresponding to said opening of said membrane, said spacer having an outer periphery disposed radially outward of said inner periphery of said base, said edge line being a suture thread wrapped between said opening and radially outward of said spacer outer periphery.

16. The left atrial appendage occlusion device of claim 15, wherein said spacer is a length of suture sewn to an inner peripheral edge of said base, said spacer being formed in an area of said base adjacent an inner peripheral edge thereof.

17. The left atrial appendage occlusion device of any one of claims 1-8, wherein said base forms said opening by a fusion or clipping process.

18. The left atrial appendage occlusion device of any one of claims 6-8, wherein said sealing portion and said anchoring portion are of a split construction, said left atrial appendage occlusion device comprising a securing member connected between a distal end of said sealing skeleton and said anchoring skeleton;

the distal part of the sealing framework is penetrated into the radial inner side of the gathering section, and the fixing piece is fixed on the radial outer side of the proximal end of the gathering section;

The second connecting piece is sleeved on the outer side of the far end of the sealing framework, at least part of the second connecting piece is positioned in a space surrounded by the radial inner side of the gathering section, and the distance between the far end of the second connecting piece and the far end of the bottom in the axial direction is between [ -2,2] mm.

19. The left atrial appendage occlusion device of any one of claims 1-8, wherein said sealing portion and said anchoring portion are of a split construction, said left atrial appendage occlusion device comprising a securing member connected between a distal end of said sealing portion and said anchoring portion;

The axial distance between the proximal end of the fixing piece and the distal end of the anchoring portion is a, and the axial distance between the proximal end of the outer peripheral surface of the anchoring portion and the distal end of the anchoring portion is b, wherein a is less than or equal to 0.8b.

20. The left atrial appendage occlusion device of any one of claims 1-8, wherein said membrane body is provided with a reinforcement at said inner periphery of said base, said reinforcement coating at least a portion of said inner periphery.

21. The left atrial appendage occlusion device of claim 20, wherein at least a portion of said reinforcement is a suture stitched around said inner periphery.