occluder

Abstract

This application relates to a plugging device, comprising: a plugging mesh, a cap connected to the distal end of the plugging mesh, and a plug connected to the proximal end of the plugging mesh; the plugging mesh is woven from multiple braided filaments and polymer strands, the proximal ends of the braided filaments are all converged into the plug, and the distal ends of the braided filaments are all converged into the cap; at least some of the distal ends of the polymer strands are not converged into the cap to form one or more first ends, and / or at least some of the proximal ends of the polymer strands are not converged into the plug to form one or more second ends. Therefore, it is not necessary to set the diameter of the cap and / or the plug to be large in order to accommodate all the polymer strands, that is, the diameter of the cap and / or the plug can be reduced to make it easier to be inserted into the sheath.

Description

Technical Field

[0001] This invention relates to the field of medical device technology, and in particular to an occluder. Background Technology

[0002] Congenital heart disease includes atrial septal defect (ASD), ventricular septal defect (VSD), and patent ductus arteriosus (PDA). A healthy heart consists of left and right atria and ventricles. The atrial septum separates the atria, and the ventricular septum separates the ventricles. The aorta, which forms the systemic circulation, connects the left atrium and left ventricle, while the pulmonary artery, which forms the pulmonary circulation, connects the right atrium and right ventricle. The aorta and pulmonary artery are not connected. An ASD is a defect in the atrial septum that allows the left and right atria to communicate; a VSD is a defect in the ventricular septum that allows the left and right ventricles to communicate; and a PDA is a defect where the aorta and pulmonary artery are connected.

[0003] When treating congenital heart disease caused by tissue defects, the common approach is to place an occluder at the defect site to close it. Typically, the occluder consists of an occlusion mesh, a proximal occluder head, and a distal occluder head. The two ends of the occlusion mesh are fixed to the occluder head and the occluder head, respectively. The diameter of the two end regions of the occlusion mesh is larger than the diameter of the middle region; that is, a cylindrical waist is formed in the middle, and disc-shaped sections are formed at both ends, with the diameter of the disc sections larger than the diameter of the defect. Taking the treatment of ventricular septal defects as an example, when placing the occluder, the waist of the occlusion mesh passes through the defect in the ventricular septum, and the disc sections at both ends are located on both sides of the ventricular septum, abutting against the sidewalls of the ventricular septum, thereby closing the defect.

[0004] In related technologies, the plugging mesh is woven from multiple braided wires. The free ends of these braided wires at the proximal end are all bundled into the plug head, while the free ends at the distal end are all bundled into the end cap. This results in a larger diameter of the plug head or end cap of the plugging device, which increases the overall radial compression dimension of the plugging device and makes it difficult to retract it into the sheath during delivery. Summary of the Invention

[0005] Based on this, the present invention proposes a plugging device that is easy to retract into the sheath.

[0006] An occlusion device includes: an occlusion mesh, a cap connected to the distal end of the occlusion mesh, and a plug connected to the proximal end of the occlusion mesh; the occlusion mesh is made of a mixture of multiple braided filaments and multiple polymer strands, the proximal ends of the braided filaments are all drawn into the plug, and the distal ends of the braided filaments are all drawn into the cap; at least some of the distal ends of the polymer strands are not drawn into the cap to form one or more first ends, and / or, at least some of the proximal ends of the polymer strands are not drawn into the plug to form one or more second ends.

[0007] In one embodiment, the distal ends of the polymer strands are not converged into the end cap, and the proximal ends of the polymer strands are not converged into the plug head.

[0008] In one embodiment, the first ends are all free ends, and / or the second ends are all free ends.

[0009] In one embodiment, the free end of the polymer strand located at the distal end is referred to as the distal free end, and the free end of the polymer strand located at the proximal end is referred to as the proximal free end; at least a portion of the proximal free ends are located outside the sealing net, and / or, at least a portion of the distal free ends are located inside the sealing net.

[0010] In one embodiment, the occlusion mesh further includes auxiliary sutures, with the plurality of first ends interconnected by one or more auxiliary sutures, and / or the plurality of second ends interconnected by one or more auxiliary sutures.

[0011] In one embodiment, the occluder includes a plurality of first end groups, which are spaced apart circumferentially in the occluder. Each first end group includes two circumferentially adjacent first ends, and the two circumferentially adjacent first ends are connected to each other to form a connecting portion; and / or, the occluder includes a plurality of second end groups, which are spaced apart circumferentially in the occluder. Each second end group includes two circumferentially adjacent second ends, and the two circumferentially adjacent second ends are connected to each other to form a connecting portion.

[0012] In one embodiment, the connection is located inside the sealing mesh.

[0013] In one embodiment, the first ends are all located inside the blocking net and are divided into multiple first end groups, each first end group including at least two first ends, and the first ends in the first end groups are interconnected to form a bundle structure; and / or, the second ends are all located inside the blocking net and are divided into multiple second end groups, each second end group including at least two second ends, and the second ends in the second end groups are interconnected to form a bundle structure; when the occluder is in the deployed state, the multiple bundle structures formed by the multiple first end groups are arranged radially spaced along the occluder, and / or, the multiple bundle structures formed by the multiple second end groups are arranged radially spaced along the occluder.

[0014] In one embodiment, the first ends are all located inside the sealing mesh, and multiple first ends extend toward the central axis of the occluder and converge at one or more connection points; and / or, the second ends are all located inside the sealing mesh, and multiple second ends extend toward the central axis of the occluder and converge at one or more connection points; the connection points are offset from the line connecting the end cap and the plug, and on the radial plane where the connection points are located, the connection points are closer to the line connecting the end cap and the plug than the sealing mesh.

[0015] In one embodiment, a locking member is further included, the distal end of which is fixedly connected to the end cap, and the proximal end of which is detachably connected to the plug head; the first ends are all located inside the sealing mesh, and a plurality of the first ends are connected to the locking member, and / or, the second ends are all located inside the sealing mesh, and a plurality of the second ends are connected to the locking member.

[0016] In one embodiment, a plurality of second ends are connected to the locking member. When the occluder is in a radially compressed state, the locking member is disengaged from the plug head, the plug head and the end cap are moved away from each other, and the plurality of second ends extend obliquely relative to the locking member toward the direction of approaching the end cap. When the occluder is in an unfolded state, the locking member is connected to the plug head, the plug head and the end cap are brought closer to each other, and the plurality of second ends extend radially along the occluder.

[0017] In one embodiment, the connection points of the plurality of first ends to the locking member are respectively located on a plurality of radial planes, and / or, the connection points of the plurality of second ends to the locking member are respectively located on a plurality of radial planes.

[0018] In one embodiment, the polymer strand comprises multiple polymer fiber strands, wherein the multiple polymer fiber strands at the proximal free end are spread out to form an enlarged structure; and / or, the multiple polymer fiber strands at the distal free end are spread out to form an enlarged structure.

[0019] The aforementioned plugging device has a plugging mesh woven from multiple braided filaments and polymer strands. The proximal ends of the braided filaments are all gathered into the plug head, and the distal ends of the braided filaments are all gathered into the end cap. At least some of the distal ends of the polymer strands are not gathered into the end cap to form one or more first ends, and / or at least some of the proximal ends of the polymer strands are not gathered into the plug head to form one or more second ends. Therefore, it is not necessary to set the diameter of the end cap and / or plug head to be large in order to accommodate all the polymer strands, that is, the diameter of the end cap and / or plug head can be reduced to make it easier to be inserted into the sheath. Attached Figure Description

[0020] Figure 1 This is a schematic diagram of the blocker in one embodiment of this application;

[0021] Figure 2 for Figure 1 Schematic diagram of the structure of the end cap and braided wire of the central plug;

[0022] Figure 3 for Figure 1 A schematic diagram of the structure of the end cap and braided wire of the central plug (stereoscopic view);

[0023] Figure 4 This is a schematic diagram showing the position of the polymer strands relative to the entire sealing net in one embodiment of this application (the sealing net is in a stretched and elongated state);

[0024] Figure 5 This is a top view of the blocking net in one embodiment of this application (within). Figure 1 (View from the main view);

[0025] Figure 6 for Figure 5 A magnified view of the central area;

[0026] Figure 7 This is a top view of the blocking net in one embodiment of this application (within). Figure 1 (View from the main view);

[0027] Figure 8 This is a top view of the blocking net in another embodiment of this application (with...). Figure 1 (View from the main view);

[0028] Figure 9 This is a schematic diagram showing the radial positional relationship between the connection point formed by the convergence of the ends of the polymer strands within the sealing mesh and the locking element in one embodiment of this application.

[0029] Figure 10 This is a schematic diagram showing the radial positional relationship between the connection point formed by the convergence of the ends of the polymer strands within the sealing mesh and the locking element in another embodiment of this application.

[0030] Figure 11 This is a schematic diagram showing the connection between the end of the polymer strand and the locking element within the sealing mesh in another embodiment of this application;

[0031] Figure 12 This is a schematic diagram showing the connection between the end of the polymer strand and the locking element within the sealing mesh in another embodiment of this application;

[0032] Figure 13 This is a schematic diagram of the enlarged structure formed at the free end of the polymer strand in another embodiment of this application;

[0033] Figure 14 This is a schematic diagram showing the position of the constraint lines in another embodiment of this application. Detailed Implementation

[0034] To make the above-mentioned objects, features, and advantages of the present invention more apparent and understandable, specific embodiments of the present invention will be described in detail below with reference to the accompanying drawings. Many specific details are set forth in the following description to provide a thorough understanding of the present invention. However, the present invention can be practiced in many other ways different from those described herein, and those skilled in the art can make similar modifications without departing from the spirit of the present invention. Therefore, the present invention is not limited to the specific embodiments disclosed below.

[0035] In the description of this invention, it should be understood that the terms "center," "longitudinal," "lateral," "length," "width," "thickness," "upper," "lower," "front," "rear," "left," "right," "vertical," "horizontal," "top," "bottom," "inner," "outer," "clockwise," "counterclockwise," "axial," "radial," and "circumferential" indicate the orientation or positional relationship based on the orientation or positional relationship shown in the accompanying drawings. They are used only for the convenience of describing this invention and simplifying the description, and do not indicate or imply that the device or element referred to must have a specific orientation, or be constructed and operated in a specific orientation. Therefore, they should not be construed as limitations on this invention.

[0036] Furthermore, the terms "first" and "second" are used for descriptive purposes only and should not be construed as indicating or implying relative importance or implicitly specifying the number of technical features indicated. Thus, a feature defined as "first" or "second" may explicitly or implicitly include at least one of that feature. In the description of this invention, "a plurality of" means at least two, such as two, three, etc., unless otherwise explicitly specified.

[0037] In this invention, unless otherwise explicitly specified and limited, the terms "installation," "connection," "linking," and "fixing," etc., should be interpreted broadly. For example, they can refer to a fixed connection, a detachable connection, or an integral part; they can refer to a mechanical connection or an electrical connection; they can refer to a direct connection or an indirect connection through an intermediate medium; they can refer to the internal communication of two components or the interaction between two components, unless otherwise explicitly limited. Those skilled in the art can understand the specific meaning of the above terms in this invention according to the specific circumstances.

[0038] In this invention, unless otherwise explicitly specified and limited, "above" or "below" the second feature can mean that the first feature is in direct contact with the second feature, or that the first feature is in indirect contact with the second feature through an intermediate medium. Furthermore, "above," "over," and "on top" of the second feature can mean that the first feature is directly above or diagonally above the second feature, or simply that the first feature is at a higher horizontal level than the second feature. "Below," "below," and "under" the second feature can mean that the first feature is directly below or diagonally below the second feature, or simply that the first feature is at a lower horizontal level than the second feature.

[0039] It should be noted that when an element is referred to as being "fixed to" or "set on" another element, it can be directly on the other element or there may be an intervening element. When an element is considered to be "connected to" another element, it can be directly connected to the other element or there may be an intervening element. The terms "vertical," "horizontal," "upper," "lower," "left," "right," and similar expressions used herein are for illustrative purposes only and do not represent the only possible implementation.

[0040] In treating congenital heart diseases such as atrial septal defects, ventricular septal defects, and patent ductus arteriosus, the common approach is to place an occluder at the defect site to close it. (See also...) Figure 1 The occlusion device includes an occlusion mesh 200, a proximal plug head 120, and a distal end cap 110. The proximal end of the occlusion mesh 200 is fixed to the plug head 120, and the distal end is fixed to the end cap 110. The diameter of the two end regions of the occlusion mesh 200 is larger than the diameter of the middle region, forming a waist 220 in the middle, a proximal disc 230 at the proximal end, and a distal disc 210 at the distal end. The radial dimensions of both the proximal disc 230 and the distal disc 210 are larger than the radial dimension (or radial width) of the waist 220. The waist 220 is cylindrical, and both the distal disc 210 and the proximal disc 230 are disc-shaped, with diameters larger than the diameter of the defect to be occluded. Taking the treatment of ventricular septal defects as an example, before implanting the occluder, the occlusion mesh 200 is first stretched axially (i.e., radially compressed) to retract into the sheath. The occluder is then delivered to the defect site on the ventricular septum through the sheath. The occluder is then released from the sheath, allowing the occlusion mesh 200 to return to its original position. Figure 1 The shape shown is the unfolded state. The waist 220 of the occlusion net 200 passes through the defect in the ventricular septum, and the distal disc 210 and proximal disc 230 are located on both sides of the ventricular septum and abut against the sidewall of the ventricular septum, thereby sealing the defect. Understandably, in other embodiments, the proximal disc 230 may be omitted, and the plug head 120 is connected to the proximal end of the waist 220 to tighten the proximal end of the waist 220, thereby closing the proximal end of the occlusion net 200.

[0041] In related technologies, the plugging mesh 200 is woven from multiple braided wires. The proximal ends of these braided wires are all gathered into the plug head 120, and the distal ends are all gathered into the end cap 110. This results in a larger diameter of the plug head 120 or end cap 110 of the plugging device, and the plug head 120 and end cap 110 themselves are more difficult to be radially compressed, thereby increasing the overall radial compression dimension of the plugging device, which is not conducive to its inclusion in the sheath during delivery.

[0042] Based on this, this application provides an occluder that can solve the above-mentioned problems. It should be noted that, in this application, "proximal end" refers to the end of the occluder that is closer to the operator during the implantation procedure, and "distal end" refers to the end that is farther away from the operator; "axial direction" refers to the length direction of the occluder when it is being transported, and "radial direction" refers to the direction of the occluder that is perpendicular to its "axial direction".

[0043] First Embodiment

[0044] See Figure 1 and Figure 4The occluder provided in the first embodiment of the present invention includes an end assembly and an occlusion mesh 200 connected to the end assembly. The end assembly includes end caps 110 spaced apart in the axial direction and plugs 120 for connection to a conveyor. The occlusion mesh 200 includes a waist portion 220 and two disc portions, which are connected one-to-one to the two ends of the waist portion 220 along the axial direction. The two disc portions are a proximal disc portion 230 connected to the proximal end of the waist portion 220 and a distal disc portion 210 connected to the distal end of the waist portion 220. The occlusion mesh 200 is formed by weaving multiple braided filaments 240 and multiple polymer strands 250 to form a three-dimensional mesh structure with openings. The braided filaments 240 are monofilaments, and the diameter of each braided filament 240 ranges from 0.1 to 0.5 mm. Polymer strand 250 comprises multiple polymer fiber threads, which are combined into a single strand. This strand can be one or more of two-ply, three-ply, or multi-ply. The specification range of each polymer strand 250 is 50D / 18F-600D / 144F to balance mechanical properties and softness requirements. 50D / 18F means that each polymer strand 250 contains 18 polymer fiber threads, and the total mass of these 18 polymer fiber threads is 50 Tennell (D). 600D / 144F has a similar meaning and will not be elaborated further here. In other embodiments, the specification range of each polymer strand 250 is 30D / 72F-100D / 72F or 50D / 72F-100D / 72F, with a twist of 1-30 twists / 10cm. To balance mechanical performance and flexibility, the occluder exerts less clamping and compression on the tissue while minimizing tissue abrasion, yet it does not detach from the defect site. The total number of braided filaments 240 and polymer strands 250 ranges from 36 to 72, and the ratio of the number of braided filaments 240 to polymer strands 250 ranges from 2:1 to 1:2. This ensures that while maintaining mechanical performance and flexibility, the occluder has a small radial dimension after stretching, allowing for delivery using a smaller diameter delivery sheath. The materials used for the braided filaments 240 and polymer strands 250 are biocompatible. For example, in this embodiment, polylactic acid is selected to make the braided filament 240 and the polymer strand 250. In other embodiments, the materials of the braided filament 240 and the polymer strand 250 can be other biodegradable polymer materials such as polydioxanone, polycaprolactone, polyurethane, polydioxanone or polyamide, or non-biodegradable polymer materials such as polyethylene terephthalate.

[0045] The braided wire 240 has a proximal end and a distal end, the distal ends of which are all gathered within the end cap 110, thus closing the distal end of the sealing net 200. The proximal ends of the braided wire 240 are all gathered within the plug head 120, thus closing the proximal end of the sealing net 200.

[0046] For example, see Figure 2 and Figure 3 The end cap 110 is generally cylindrical and may include a receiving interlayer 111 with an opening at one end. The opening of the receiving interlayer 111 faces the distal end of the end cap 110. The distal end of the braided wire 240 can extend into the receiving interlayer 111 through the opening and be fixedly connected to the end cap 110 by means of heat fusion or the like, so that the proximal end of the end cap 110 is located in the inner cavity of the sealing mesh 200. The plug head 120 is also generally cylindrical and similarly has a receiving interlayer 111. The opening of the receiving interlayer 111 of the plug head 120 faces the distal end of the plug head 120. The proximal end of the braided wire 240 can extend into the receiving interlayer 111 of the plug head 120 through the opening and be fixedly connected to the plug head 120 by means of heat fusion or the like, so that the plug head 120 is located entirely outside the sealing mesh 200. Since all parts except the distal end face of the end cap 110 are located inside the occlusion mesh 200, problems such as slow endothelial migration, high thrombosis rate, and easy snagging of valves and chordae tendineae during implantation, which can damage cardiac tissue, can be avoided due to the protrusion of the end cap 110. In other embodiments, the end cap 110 may be located outside the occlusion mesh 200, while the plug head 120 may be at least partially located inside the occlusion mesh 200. In other embodiments, the braided wire 240 may be connected to the end cap 110 and the plug head 120 by other connection methods, and the aforementioned receiving interlayer 111 may be omitted.

[0047] The polymer strand 250 has a proximal end and a distal end, with at least a portion of the distal end of the polymer strand 250 not constricted within the end cap 110, and / or, at least a portion of the proximal end of the polymer strand 250 not constricted within the plug head 120. Alternatively, it can be understood that at least a portion of the distal end of the polymer strand 250 is located outside the end cap 110 and separated from it (“separated” means not directly connected), and / or, at least a portion of the proximal end of the polymer strand 250 is located outside the plug head 120 and separated from it. Because at least a portion of the distal end of the polymer strand 250 is not constricted within the end cap 110, and / or, at least a portion of the proximal end of the polymer strand 250 is not constricted within the plug head 120, it is advantageous to reduce the radial dimensions of the end cap 110 and / or the plug head 120, making it easier to retract into the sheath during delivery.

[0048] In this embodiment, the proximal ends of all polymer strands 250 are not gathered into the cap 120, and the distal ends of all polymer strands 250 are not gathered into the end cap 110. That is, both the cap 120 and the end cap 110 only gather the ends of the braided filaments 240 within them, without gathering the ends of the polymer strands 250. Therefore, the radial dimensions of the cap 120 and the end cap 110 can be reduced to a large extent.

[0049] In other embodiments, the proximal ends of some polymer strands 250 are not converged into the plug head 120, and the distal ends of some polymer strands 250 are not converged into the end cap 110. For example, 1 / 4 to 3 / 4 of the polymer strands 250 have proximal ends not converged into the plug head 120, and 1 / 4 to 3 / 4 of the polymer strands 250 have distal ends not converged into the end cap 110; the proximal ends of the remaining polymer strands 250 converge into the plug head 120, and the distal ends of the remaining polymer strands 250 converge into the end cap 110. This arrangement increases the mesh density of the sealing mesh 200 near the end component region, thereby improving its flow resistance and resulting in a better sealing effect. Therefore, it can balance a smaller end cap diameter with better sealing capability.

[0050] In other embodiments, at least a portion of the polymer strand 250 has its distal end not converged into the end cap 110, while its proximal end converges into the end cap 120. Alternatively, at least a portion of the polymer strand 250 has its proximal end converged into the end cap 120, while its distal end is not converged into the end cap 110.

[0051] The distal end of the polymer strand 250 that is not converged into the end cap 110 is designated as the first end, and the proximal end of the polymer strand 250 that is not converged into the plug head 120 is designated as the second end. When the occluder is in a radially compressed state, all first ends are closer to the plug head 120 than the distal end of the braided filament 240, and / or all second ends are closer to the end cap 110 than the proximal end of the braided filament 240. For example, in this embodiment, all first ends are closer to the plug head 120 than the distal end of the braided filament 240, and all second ends are closer to the end cap 110 than the proximal end of the braided filament 240. This makes the area between the first end and the end cap 110, and / or the area between the second end and the plug head 120, more deformable, which can better guide the occlusion mesh 200 to be radially compressed into the sheath. In addition, it also makes the area around the end cap 110 and the plug head 120 more flexible, and allows the occlusion mesh 200 to conform to different tissue morphologies.

[0052] In this embodiment, the first ends of the polymer strands 250 are all free ends (for ease of description, the free end of the polymer strand 250 located at the distal end is referred to as the distal free end 250a), and / or, the second ends of the polymer strands 250 are all free ends (for ease of description, the free end of the polymer strand 250 located at the proximal end is referred to as the proximal free end 250b). Since the polymer strands 250 are formed by the convergence of multiple polymer fiber threads, and the braided filaments 240 and the polymer strands 250 are interwoven to form a mesh structure, the free ends of the polymer strands 250 do not affect the maintenance of the overall mesh structure. However, because the free ends of the polymer strands 250 are unrestrained, the multiple polymer fiber threads within them spread out and expand, making it easier to adsorb blood and form thrombi that promote the process of endothelialization. In addition, the free end of the polymer strand 250 can move relative to the sealing mesh 200. When implanted into the defect, the free end of the polymer strand 250 will swing with the impact of blood and the heartbeat, which will change the hemodynamics around it. The blood flow rate is easy to slow down around it, and thrombi are easy to form in the surrounding area, thereby accelerating the epithelialization process in the surrounding area. When the distal ends of the polymer strands 250 that are not converged into the end cap 110 are all free ends, the end cap 110 can be endothelialized faster because these free ends are close to the end cap 110. When the distal ends of the polymer strands 250 that are not converged into the end cap 110 are all free ends, the end cap 120 can be endothelialized faster because these free ends are close to the plug head 120. In particular, for biodegradable end caps, this can reduce the possibility of end cap failure caused by degradation and loss of mechanical properties at the connection between the end cap 200 and the end cap before endothelialization is completed due to a reduction in the number of polymer strands 250 converged into the end cap 110.

[0053] In this embodiment, for example, the proximal ends of all polymer strands 250 are not constricted within the thrombus head 120 and are all free ends, and the distal ends of all polymer strands 250 are not constricted within the end cap 110 and are all free ends. The distal free ends 250a of the polymer strands 250 are arranged around the end cap 110, and the proximal free ends 250b of the polymer strands 250 are arranged around the thrombus head 120. This arrangement not only reduces the radial dimensions of the end cap 110 and the thrombus head 120, but also allows a ring of thrombus to form rapidly around the end cap 110 and the thrombus head 120, thereby further accelerating the endothelialization process of the end cap 110 and the thrombus head 120.

[0054] Further, see Figure 1 and Figure 4At least a portion of the proximal free ends 250b of the polymer strands 250 are located outside the sealing net 200, and at least a portion of the distal free ends 250a of the polymer strands 250 are located inside the sealing net 200. For example, in this embodiment, all proximal free ends 250b of the polymer strands 250 are located outside the sealing net 200, and all distal free ends 250a of the polymer strands 250 are located inside the sealing net 200. This design allows the proximal free end 250b of the polymer strand 250 to easily form a fluffy shape when compressed by the sheath. After being released from the sheath, the proximal free end 250b of the polymer strand 250, located outside the occlusion net 200, helps to further accelerate the endothelialization process of the embolus head 120. On the other hand, the distal free end 250a of the polymer strand 250 and the embolus head 110 are both located inside the occlusion net 200 (i.e., in the lumen of the occlusion net 200). The distal free end 250a of the polymer strand 250 can change the hemodynamics inside the occlusion net 200, thereby rapidly forming a thrombus inside the occlusion net 200, which in turn accelerates the endothelialization process and creates a more effective occlusion of the defect. In other embodiments, the proximal free ends 250b of some polymer strands 250 are located outside the sealing net 200, the proximal free ends 250b of some polymer strands 250 are located inside the sealing net 200, the distal free ends 250a of some polymer strands 250 are located outside the sealing net 200, and the distal free ends 250a of some polymer strands 250 are located inside the sealing net 200. In other embodiments, all proximal free ends 250b of polymer strands 250 are located inside the sealing net 200, and all distal free ends 250a of polymer strands 250 are located outside the sealing net 200; or, all free ends of polymer strands 250 are located inside the sealing net 200; or, all free ends of polymer strands 250 are located outside the sealing net 200.

[0055] Furthermore, referring to Figure 4 The occluder also includes a locking member 130, the distal end of which is fixedly connected to the end cap 110, and the proximal end of which is detachably connected to the plug head 120. After the occluder is released, the distal end of the occluder can be gradually pulled towards the proximal end through the locking member 130, allowing the occluder to return to its unfolded state. Then, the distance between the distal and proximal ends of the occluder is fixed through the interference fit between the locking member 130 and the plug head 120. Thus, the occluder restores and maintains a stable double-disc structure after release. It is understood that the shape, structure, and connection method of the locking member 130 with the end cap 110 and the plug head 120 are not limited to the methods provided in this embodiment, and can also adopt structures and connection methods commonly used in the art. It is understood that in other embodiments, the locking member 130 can also be omitted, as long as the medical device is structurally stable in its naturally unfolded state.

[0056] Since the distal free end 250a and proximal free end 250b of the polymer strand 250 in this embodiment can move relative to the sealing net 200, the locking member 130 will not be hindered from moving within the sealing net 200.

[0057] Second Embodiment

[0058] See Figure 1 , Figure 5 and Figure 6 The occluder provided in the second embodiment of the present invention is largely the same as that in the first embodiment, except that the occlusion net 200 further includes auxiliary sutures, and the multiple first ends of the polymer strands 250 in the occlusion net 200 are connected to each other by one or more auxiliary sutures, and / or the multiple second ends of the polymer strands 250 are connected to each other by one or more auxiliary sutures.

[0059] For example, the sealing net 200 also includes a first auxiliary suture 260 and a second auxiliary suture 270. The polymer strands 250 of the sealing net 200 include two sets of second ends distributed circumferentially, wherein the first set of second ends is closer to the plug head 120 than the second set of second ends. The first set of second ends is connected by the circumferentially extending first auxiliary suture 260, and the second set of second ends is connected by the circumferentially extending second auxiliary suture 270, wherein the first auxiliary suture 260 is closer to the plug head 120 than the second auxiliary suture 270.

[0060] In this way, on the one hand, the second ends of the first group and the second ends of the second group are located on different planes when the sealing mesh 200 is in a compressed state, which can prevent the second ends from concentrating on the same plane and causing problems such as accumulation and large radial compression size. On the other hand, it can restrict the movement of the second ends of the polymer strands 250, reduce the number of free strands near the plug head 120, thereby improving the strength of the sealing mesh 200 and increasing the mesh density, thus improving the sealing capacity of the area. In particular, for the second ends located outside the sealing mesh 200 and that are too long, restricting their movement with the second auxiliary suture helps to prevent them from folding towards the sealing mesh 200 due to the scraping of the sheath opening during insertion, thus avoiding the problem of increased local compression size caused by the folding of the second ends.

[0061] Preferably, the two ends of the first auxiliary suture 260 are connected to form a connecting unit (not shown) and extend into the inner side of the sealing mesh 200, and the two ends of the second auxiliary suture 270 are also connected to form a connecting unit and extend into the inner side of the sealing mesh 200. Specifically, the connecting units formed by connecting the two ends of the auxiliary sutures include knotting, fusion bonding, suturing, etc. After forming the connecting unit, it is inserted into the inner side of the sealing mesh 200 through the mesh openings. In this way, the outer surface of the sealing mesh 200 can be kept as flat as possible, thereby reducing damage to surrounding tissues. In other embodiments, the connecting unit of at least one of the first auxiliary suture 260 and the second auxiliary suture 270 may also be located on the outer side of the sealing mesh 200.

[0062] Similarly, a third and fourth auxiliary suture can also be provided within the distal disc portion 210. The polymer strands 250 of the sealing mesh 200 include two sets of first ends distributed circumferentially, wherein the first ends of the first set are closer to the end cap 110 than the first ends of the second set. The first ends of the first set are connected by a third auxiliary suture extending circumferentially, and the first ends of the second set are connected by a fourth auxiliary suture extending circumferentially, the third auxiliary suture being closer to the end cap 110 than the fourth auxiliary suture.

[0063] In other embodiments, any one or two of the first auxiliary suture 260, the second auxiliary suture 270, the third auxiliary suture, and the fourth auxiliary suture may be omitted.

[0064] Third Embodiment

[0065] See Figure 1 , Figure 7 The occluder provided in the third embodiment of the present invention is substantially the same as that in the first embodiment, except that the plurality of first ends formed by the polymer strands 250 can be divided into a plurality of first end groups, which are spaced apart in the circumferential direction of the occluder. Each first end group includes two circumferentially adjacent first ends, and the two circumferentially adjacent first ends are connected to each other to form a connecting portion 251; and / or, the plurality of second ends formed by the polymer strands 250 can be divided into a plurality of second end groups, which are spaced apart in the circumferential direction of the occluder. Each second end group includes two circumferentially adjacent second ends, and the two circumferentially adjacent second ends are connected to each other to form a connecting portion 251. The connecting portion 251 can be formed by one or more of knotting connection, heat fusion connection, and stitching connection.

[0066] This configuration restricts the movement of the first and / or second ends of the polymer strands 250, reducing the number of free strands near the end cap 110 and / or the plug 120. This improves the strength of the sealing mesh 200 in this area and also increases the mesh density, thereby enhancing the sealing capability of the area. Particularly for the second end located outside the sealing mesh 200, restricting its movement with the second auxiliary suture helps prevent the polymer strands 250 from loosening due to friction and compression from the sheath during insertion and removal.

[0067] In other embodiments, the first end group may include more than two first ends, such as three, four or more, and the multiple first ends are connected to form a connecting portion 251. Similarly, the second end group may also include more than two second ends, and the multiple second ends are connected to form a connecting portion 251.

[0068] Preferably, the connecting part 251 can be inserted into the inner side of the sealing net 200 through the mesh of the sealing net 200, so that the outer surface of the sealing net 200 has as few obvious protrusions as possible, thereby reducing damage to the surrounding tissues.

[0069] In other embodiments, auxiliary sutures, as in the second embodiment, can be provided to connect and constrain the connecting portions 251 located within the same disc. For example, the first end of the auxiliary suture extends from the outside to the inside of the sealing mesh 200 through a mesh opening on one side of the connecting portion 251, passes around the connecting portion 251, and then exits through a mesh opening on the other side of the connecting portion 251 to the outside of the sealing mesh 200. After passing around the braided wire 240 adjacent to the connecting portion 251, it again passes through the inside of the sealing mesh 200… This alternating perforation is repeated to alternately connect multiple connecting portions 251 and multiple braided wires 240 to the auxiliary suture. After the auxiliary suture has wrapped around all the connecting portions 251 and connected them, the tail end and the first end of the auxiliary suture are tied together and secured in the corresponding mesh opening. The above embodiment only provides one winding method; in other embodiments, other winding methods can also be used.

[0070] Fourth embodiment

[0071] See Figure 1 and Figure 8The occluder provided in the fourth embodiment of the present invention is largely the same as that in the first embodiment, except that the plurality of first ends formed by the polymer strands 250 are all located inside the occlusion net 200 and are divided into a plurality of first end groups, each first end group including at least two first ends, and the first ends within the first end groups are interconnected to form a bundle structure; and / or, the plurality of second ends formed by the polymer strands 250 are all located inside the occlusion net 200 and are divided into a plurality of second end groups, each second end group including at least two second ends, and the second ends within the second end groups are interconnected to form a bundle structure. The method of connecting to form the bundle structure may include one or more of knot connection, heat fusion connection, and stitch connection. For example, the occlusion net 200 has a virtual axial plane inside, and the central axis of the occluder is located on the virtual axial plane. Taking the first end group as an example, the first ends within the first end group are mirror images of each other on both sides of the virtual axial plane and extend towards each other in a direction close to each other before connecting to each other. The connection method of the second ends within the second end group can be implemented with reference to the method of the first end group, and will not be described in detail here.

[0072] When the occluder is in the deployed state, multiple bundle-like structures formed by multiple first end groups are arranged radially spaced apart, and / or multiple bundle-like structures formed by multiple second end groups are arranged radially spaced apart. This arrangement allows the multiple bundle-like structures to block blood to a certain extent, improving the occlusion effect and endothelialization speed near the endcap 110 and / or the plug 120. Furthermore, since adjacent bundle-like structures are separated and spaced apart, and can move relative to each other radially, when the locking member 130 needs to move within the occlusion net 200, it can pass through the gaps between adjacent bundle-like structures, thus not hindering the movement of the locking member 130 within the occlusion net 200.

[0073] Understandably, when the occluder is in the deployed state, the aforementioned bundle structure is not necessarily located on the same radial plane of the occluder, but can be distributed in multiple radial planes. This is beneficial for forming multiple barriers to blood and can prevent the bundle structure from accumulating on the same radial plane when the occluder is in the radially compressed state, thus preventing excessive radial size.

[0074] Fifth embodiment

[0075] See Figure 1 , Figure 9The occluder provided in the fifth embodiment of the present invention is largely the same as that in the first embodiment, except that the plurality of first ends formed by the polymer strands 250 are all located inside the occlusion net 200, and the plurality of first ends extend toward the central axis of the occluder and converge to the same connection point 253; and / or, the plurality of second ends formed by the polymer strands 250 are all located inside the occlusion net 200, and the plurality of second ends extend toward the central axis of the occluder and converge to the same connection point 253. The connection point 253 is offset from the line connecting the end cap 110 and the plug head 120, and on the radial plane where the connection point 253 is located, the connection point 253 is closer to the line connecting the end cap 110 and the plug head 120 than the occlusion net 200. This arrangement allows the converging first ends and / or converging second ends to block blood to a certain extent, improving the occlusion effect and endothelialization speed near the end cap 110 and / or the plug head 120. Furthermore, since the converging connection point 253 is offset from the line connecting the end cap 110 and the bolt head 120, it does not obstruct the movement of the locking member 130 inside the sealing net 200.

[0076] Reference Figure 10 In other embodiments, multiple first ends extend toward the central axis of the plug and converge at multiple connection points 253 (e.g., two connection points 253), and / or, multiple second ends formed by polymer strands 250 are located inside the plugging mesh 200, with each second end extending toward the central axis of the plug and converging at multiple connection points 253 (e.g., two connection points 253). The multiple connection points 253 are offset from the line connecting the end cap 110 and the plug head 120, and in the radial plane where the connection points 253 are located, they are closer to the line connecting the end cap 110 and the plug head 120 than the plugging mesh 200. The multiple connection points 253 within the same disc are radially spaced, which facilitates the smooth passage of the locking member 130.

[0077] Understandably, when the occluder is in the deployed state, the connection points 253 within the same disc are not necessarily located on the same radial plane of the occluder, but can be distributed across multiple radial planes. This is beneficial for creating multiple barriers to blood flow and can prevent the connection points 253 from accumulating on the same radial plane when the occluder is in the radially compressed state, thus preventing excessive radial dimensions.

[0078] Sixth Embodiment

[0079] See Figure 11The occluder provided in the sixth embodiment of the present invention is largely the same as that in the first embodiment, except that the plurality of first ends formed by the polymer strands 250 are all located inside the occlusion net 200 and are all connected to the locking member 130, and / or the plurality of second ends formed by the polymer strands 250 are all located inside the occlusion net 200 and are all connected to the locking member 130. This arrangement allows the converging first ends and / or converging second ends to block blood flow to a certain extent, improving the occlusion effect and endothelialization speed near the cap 110 and / or the plug 120. Furthermore, since the first ends and / or second ends are connected to the locking member 130, the movement of the locking member 130 within the occlusion net 200 is not hindered. In particular, when multiple second ends are connected to the locking member 130, if the occluder is in a radially compressed state, the locking member 130 and the plug head 120 are disengaged. At this time, the distance between the connection point of the second end and the locking member 130 and the plug head 120 increases, and the second end extends obliquely toward the end cap 110. Therefore, the radial compression dimension near the plug head 120 will not be too large. If the occluder is in an unfolded state, the locking member 130 and the plug head 120 are engaged. At this time, the distance between the connection point of the second end and the locking member 130 and the plug head 120 also decreases, and the second end extends radially, thereby improving the occlusion effect and endothelialization speed near the plug head 120.

[0080] Furthermore, the polymer strand 250 can be a high-loft strand, such as core-spun yarn. When multiple second ends are connected to the locking member 130, the second ends are in a taut state when the occluder is in a compressed state, and their filament diameter is small. Therefore, it is beneficial to reduce the compression size. When the occluder is in an unfolded state, the second ends return to a loose state. Therefore, it is beneficial to absorb blood and improve the occlusion effect and endothelialization speed.

[0081] In other embodiments, the polymer strands 250 may also be strands that are elastic in the length direction, which is beneficial for radial compression and facilitates the movement of the locking member 130 within the sealing net 200.

[0082] See Figure 12 In other embodiments, the connection points of the multiple first ends to the locking member 130 may be located on multiple radial planes, and / or the connection points of the second ends to the locking member 130 may be located on multiple radial planes. This facilitates the formation of multiple barriers to blood flow and prevents the connection points from accumulating on the same radial plane when the occluder is in a radially compressed state, thus avoiding excessive radial dimensions.

[0083] Seventh Embodiment

[0084] Reference Figure 13The occluder provided in the seventh embodiment of the present invention is substantially the same as that in the first embodiment, except that multiple polymer fiber threads at the proximal free end 250b of the polymer strand 250 are spread out to form an enlarged structure 254; and / or, multiple polymer fiber threads at the distal free end 250a of the polymer strand 250 are spread out to form an enlarged structure 254. The polymer fiber threads in the enlarged structure 254 can be regularly or irregularly distributed. This enlarged structure 254 not only helps to limit the range of motion of the proximal free end 250b and / or the distal free end 250a of the polymer strand 250, but also further improves the blood adsorption capacity and endothelialization rate in the area where it is located.

[0085] Furthermore, the size of the enlarged structure 254 is larger than the size of the mesh openings in its region, which effectively prevents its radial movement. It is understood that the present invention does not limit the size of the enlarged structure 254; in other embodiments, the size of the enlarged structure 254 may be smaller than or equal to the size of the mesh openings in its region.

[0086] In other embodiments, the polymer fiber lines in adjacent enlarged structures 254 may interweave, meaning that a polymer fiber line in one enlarged structure 254 may extend into an adjacent enlarged structure 254. This allows adjacent enlarged structures 254 to connect with each other and restrict each other's range of motion.

[0087] Eighth embodiment

[0088] The occlusion device provided in the eighth embodiment of the present invention is based on any one of the first to seventh embodiments, and refers to... Figure 14 The sealing net 200 also includes a constraint line 280, at least one of the connection points between the disc and the waist 220 is provided with a constraint line 280, the constraint line 280 extends circumferentially along the sealing net 200 and at least surrounds the sealing net 200 once.

[0089] Specifically, constraint lines 280 are provided at the connections between the distal disc 210 and the proximal disc 230 and the waist 220. Since the braided filaments 240 and the polymer strands 250 are both made of polymer materials, the angle between the distal disc 210, the proximal disc 230, and the waist 220 may increase during the sheathing and unsheathing processes of the occluder. This increases the diameter of the connection between the waist 220 and the disc, affecting the occlusion capacity. By providing constraint lines 280 at the connections between the distal disc 210 and the waist 220, and also at the connections between the proximal disc 230 and the waist 220, deformation at the connections between the waist 220 and the disc can be prevented, thereby stabilizing the occluder's configuration and preventing a weakening of its occlusion capacity.

[0090] The aforementioned constraint line 280 is a strand composed of multiple polymer fiber threads, which can be one or more of two-ply, three-ply, or multi-ply threads. The specifications of each polymer strand 250 range from 50D / 18F to 600D / 144F to balance mechanical properties and flexibility requirements.

[0091] The material for constraint line 280 can be selected from biodegradable polymers such as polylactic acid, polydioxanone, polycaprolactone, polyurethane, polydioxanone or polyamide, or non-biodegradable polymers such as polyethylene terephthalate.

[0092] The constraint line 280 is stitched and fixed to the sealing net 200. The constraint line 280 includes multiple outer line segments 281. Figure 14 (represented by solid line) and multiple inner line segments 282 ( Figure 14 (Indicated by the dashed line), inner segment 282 refers to the segment located inside the braided wire 240 and / or polymer strand 250, and outer segment 281 refers to the segment located outside the sealing net 200; inner segment 282 and outer segment 281 are arranged alternately in the circumferential direction of the sealing net 200. The following example illustrates the routing method of constraint line 280: Select a starting point inside the braided net 200, pass the constraint line 280 from the starting point to the outside of the braided net 200, and then extend the constraint line 280 on the outside of the braided net 200 to form outer segment 281, and then pass it inside the braided wire 240 and / or polymer strand 250, for example, pass it inside the sealing net 200 and pass it around one or more braided wires 240 and / or polymer strand 250 to form inner segment 282, and then pass it out to the outside of the braided net 200. Repeat this wiring method until the braided mesh 200 is circled at least once and the starting point is returned. Gather the two ends of the constraint wire 280 and tie them together. Cut off any excess constraint wire 280 and use a heat-melting tool (e.g., a soldering iron) to melt the ends of the constraint wire 280 to 0.5mm to 1.5mm from the knot, ensuring the knot is inside the braided mesh 200 to avoid exposure and potential tissue damage. In other embodiments, other wiring methods may be used, and the knot may be located outside the braided mesh 200.

[0093] In this embodiment, since the constraint line 280 includes multiple outer line segments 281 and multiple inner line segments 282, and the inner line segments 282 and outer line segments 281 are alternately arranged in the circumferential direction of the sealing net 200, the constraint line 280 can uniformly constrain the connection between the disc and the waist 220. In addition, the constraint line 280 itself can also be partially distributed on the outer side of the sealing net 200 and partially located on the inner side of the sealing net 200, avoiding the problem that the constraint line 280 is too distributed on the outer side of the sealing net 200 and is easily worn or hooked by the sheath.

[0094] Ninth Embodiment

[0095] The occluder provided in the ninth embodiment of the present invention is based on any one of the first to eighth embodiments, wherein the aforementioned polymer fiber thread has a hollow structure and / or the aforementioned strand has a hollow structure, and the hollow structure has at least one cavity extending along the length direction of the hollow structure. The hollow structure has superior blood adsorption performance compared to the solid structure. After the occluder of this embodiment is implanted into a biological body, the hollow structure exhibits a wicking effect, which accelerates the entry of blood into its cavity and increases the blood transport rate within the cavity, thereby enabling its interior to quickly fill with blood. Once its interior is filled with blood, the blood no longer flows rapidly within its cavity, thus allowing for faster thrombus formation and accelerating the endothelialization process of the occluder.

[0096] The hollow ratio of a hollow structure affects its mechanical and blood adsorption properties. The hollow ratio refers to the percentage of the cross-sectional area of ​​the hollow portion (i.e., the cavity) to the total cross-sectional area of ​​the hollow structure. A higher hollow ratio results in better blood adsorption and greater flexibility, but also weaker support. Therefore, to achieve a good balance between blood adsorption and mechanical properties, the hollow ratio can be set between 1% and 30%. When the hollow ratio falls within this range, the hollow structure exhibits good blood adsorption, wall adhesion, and superior support, preventing insufficient support after deployment due to an excessively high hollow ratio, and avoiding excessive deformation under pressure.

[0097] The hollow structure has an outer contour shape and an inner contour shape in its cross-section. The outer contour shape is the cross-sectional shape of the outer surface of the hollow structure, and the inner contour shape is the cross-sectional shape of the cavity. The outer contour shape includes, but is not limited to, one or more of the following: circular, elliptical, triangular, square, X-shaped, and Y-shaped. The inner contour shape also includes, but is not limited to, one or more of the following: circular, elliptical, triangular, square, X-shaped, and Y-shaped. Within the same hollow structure, the outer and inner contour shapes may be the same or different. In this embodiment, the outer and inner contour shapes of the hollow structure are approximately circular. In other embodiments, the outer and inner contour shapes of the hollow structure may be selected from the aforementioned non-circular shapes. Compared to a circular shape, the aforementioned other non-circular shapes allow the hollow structure to obtain a larger blood contact area, thereby exhibiting superior blood adsorption performance. In particular, when the cavity of the hollow structure has a non-circular cross-sectional contour, it is easier to form a narrow space within the cavity, making it easier for blood to coagulate and form a thrombus, thus further accelerating the endometrialization process of the occluder. Furthermore, when the outer contour shape is non-circular, it can increase the cohesion between the interwoven hollow structures, prevent slippage between the interwoven hollow structures, improve the dimensional stability of the occluder, and increase the porosity. Therefore, it can not only improve the mechanical properties of the occluder, but also further improve the blood adsorption performance, so as to accelerate the endothelialization process of the occluder.

[0098] Tenth Embodiment

[0099] The occluder provided in the tenth embodiment of the present invention is based on any one of the first to eighth embodiments. The polymer fiber thread has a hollow structure and / or the strand has a core-skin structure. The core-skin structure includes a core layer and a skin layer surrounding the outer surface of the core layer. In the core-skin structure, the structure of the skin layer differs from that of ordinary coatings; its structure is more uniform, the molecular chains are more regularly arranged, the orientation is higher, and the crystallinity is also higher. For example, in this embodiment, the crystallinity of the skin layer can be 40%-70%. In other embodiments, the crystallinity of the skin layer may differ from that in this embodiment. The core layer of the core-skin structure has a looser structure and lower crystallinity than the skin layer. When the occluder is implanted into the body, due to the difference in structure between the skin layer and the core layer, when the core layer is filled with blood, the blood no longer flows rapidly within it, thus allowing for faster thrombus formation and accelerating the endometrialization process of the occluder. In addition, the strength of the cortex (e.g., fracture strength, fatigue strength, support performance) is better than that of the core, while the core is more flexible. Therefore, the cortex-core structure as a whole has better mechanical strength and better adhesion performance, which can better fit tightly to the defect site and accelerate the ingrowth of endothelial cells into the thrombus to further accelerate the endothelialization process.

[0100] The molecular weight of the polymer material in the outer layer is greater than that in the core layer. For example, the weight-average molecular weight of the biodegradable polymer material in the outer layer is 50,000 Da to 500,000 Da, while that in the core layer is 20,000 Da to 200,000 Da. Therefore, the outer layer, located outside the core layer, can protect the core layer to a certain extent, preventing it from degrading too quickly and causing premature damage to the occluder before complete internal membrane formation, thus affecting the repair of the defect.

[0101] The core layer has a porous structure, and the pores in the core layer make it easy for blood to clot and form thrombi, which in turn accelerates the intimalization process of the occluder. In other embodiments, the core layer may not be porous, but may be a solid or hollow structure.

[0102] In this embodiment, the cross-sectional shape of the skin layer includes, but is not limited to, one or more of the following: circular, elliptical, triangular, square, X-shaped, and Y-shaped. The cross-sectional shape of the core layer includes, but is not limited to, one or more of the following: circular, elliptical, triangular, square, X-shaped, and Y-shaped. Within the same skin-core structure, the cross-sectional shapes of the skin layer and the core layer can be the same or different. Compared to a circular shape, the aforementioned non-circular shapes allow the skin-core structure to obtain a larger blood contact area, thereby exhibiting superior blood adsorption performance. Furthermore, when the cross-sectional shape of the skin layer is non-circular, it increases the weaving strength between the interwoven skin-core structures and simultaneously increases porosity. Therefore, it not only improves the mechanical properties of the occluder but also further enhances the blood adsorption performance, thereby accelerating the endothelialization process of the occluder.

[0103] The technical features of the above embodiments can be combined in any way. For the sake of brevity, not all possible combinations of the technical features in the above embodiments are described. However, as long as there is no contradiction in the combination of these technical features, they should be considered to be within the scope of this specification.

[0104] The embodiments described above are merely illustrative of several implementation methods of this application, and while the descriptions are specific and detailed, they should not be construed as limiting the scope of this application. It should be noted that those skilled in the art can make various modifications and improvements without departing from the concept of this application, and these modifications and improvements all fall within the protection scope of this application. Therefore, the protection scope of this application should be determined by the appended claims.

Claims

1. A sealing device, characterized in that, include: The sealing net comprises a sealing head connected to the distal end of the sealing net and a plug head connected to the proximal end of the sealing net; the sealing net is composed of multiple biodegradable braided filaments and multiple biodegradable polymer strands, wherein the proximal ends of the braided filaments are all gathered into the plug head, and the distal ends of the braided filaments are all gathered into the sealing head; the distal ends of all the polymer strands are not gathered into the sealing head to form multiple first ends, and the proximal ends of all the polymer strands are not gathered into the plug head to form multiple second ends; Wherein, the first end is a free end, and the second end is a free end; the free end of the polymer strand located at the distal end is denoted as the distal free end, and the free end of the polymer strand located at the proximal end is denoted as the proximal free end; the proximal free end and the plug head are both located outside the sealing net, and the proximal free end is arranged around the plug head; the distal free end and the end cap are located inside the sealing net, and the distal free end is arranged around the end cap. The polymer strand comprises multiple polymer fiber strands, wherein the multiple polymer fiber strands at the proximal free end are spread out to form an enlarged structure; and / or, the multiple polymer fiber strands at the distal free end are spread out to form an enlarged structure.

2. The occluder according to claim 1, characterized in that, It also includes a locking element, the distal end of which is fixedly connected to the end cap, and the proximal end of which is detachably connected to the bolt head.

3. The occluder according to claim 1, characterized in that, The polymer fiber thread has a hollow structure, and the hollow structure has at least one cavity extending along the length direction of the hollow structure.

4. The occluder according to claim 3, characterized in that, The hollow structure has a hollow ratio of 1% to 30%.

5. The plugging device according to claim 3, characterized in that, The outer contour shape of the hollow structure is one or more of the following: circular, elliptical, triangular, square, X-shaped, or Y-shaped; and / or, the cross-sectional shape of the cavity of the hollow structure is one or more of the following: circular, elliptical, triangular, square, X-shaped, or Y-shaped.

6. The occluder according to claim 1, characterized in that, The polymer strand has a core-skin structure, which includes a core layer and a skin layer that wraps around the outer surface of the core layer. The crystallinity of the core layer is lower than that of the skin layer, and the molecular weight of the polymer material in the skin layer is greater than that of the polymer material in the core layer.

7. The occluder according to claim 6, characterized in that, The core layer has a porous structure, and / or the crystallinity of the skin layer is 40% to 70%.

8. The occluder according to claim 6, characterized in that, The cross-sectional shape of the skin layer is one or more of the following: circular, elliptical, triangular, square, X-shaped, or Y-shaped; and / or, the cross-sectional shape of the core layer is one or more of the following: circular, elliptical, triangular, square, X-shaped, or Y-shaped.

9. The occluder according to claim 1, characterized in that, The size of the enlarged structure is larger than the size of the mesh in the region where the enlarged structure is located; and / or, a polymer fiber thread in one of the enlarged structures extends into an adjacent enlarged structure.

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