CN114366183A - Plugging device and plugging system - Google Patents

Abstract

The present application discloses a plugging device and a plugging system. The occlusion device is used to close the gap in the tissue, and the occlusion device includes a support frame and a membrane. The support frame is used to release at the gap, and the circumferential edge of the support frame is used to cover the tissue around the gap. The cover film covers at least one side of the support frame, and at least part of the cover film is seamlessly connected with the support frame. Using the plugging device and plugging system of the present application, based on covering at least one side of the support frame with a film, at least part of the film is seamlessly connected with the support frame, thereby reducing the surface of the plugging device that needs to be endothelialized It improves the connection strength between the membrane and the supporting skeleton, reduces the possibility of the membrane and the supporting skeleton detaching from each other during the process of endothelialization, and avoids the better local endothelialization of the plugging device, and the faster local endothelialization. It is not easy to form complications such as thrombosis, inflammatory reaction and endothelial hyperplasia, which is beneficial to improve the rate of endothelialization of the occlusion device.

Description

Blocking devices and blocking systems

technical field

The present application relates to the technical field of medical devices, and in particular, to a plugging device and a plugging system.

Background technique

Foramen Ovale (Foramen Ovale) is a physiological channel in the cardiac atrial septum in the embryonic stage, which is generally closed within the first year after birth, while about 20% to 25% of adults are incompletely closed, and the foramen ovale is not fully closed. Closure is one of the most common congenital heart abnormalities in adults.

In recent years, studies have found that Patent Oval Foramen (PFO) is closely related to unexplained ischemic stroke and migraine. Studies suggest that PFO can act as a "paradox emboli" from the venous circulation, leading to stroke. A large number of clinical data have confirmed that 10% to 40% of PFO is closely related to the occurrence of unexplained stroke. At least 150,000 to 500,000 stroke patients in China are caused by PFO every year. A series of studies have shown that the incidence of PFO in patients with unexplained stroke under the age of 55 is about 47% to 56%.

At present, the treatment methods for PFO are mainly drug treatment and PFO blockade (PFO blockade has obvious advantages compared with drugs).

However, in the patent foramen ovale sealing device in the prior art, the membrane is combined on the skeleton by sutures and other fixing means, resulting in poor adhesion between the disc surface and the tissue to be blocked, resulting in an excessively slow endothelialization rate , the local endothelialization of the plugging device is obvious, the partial endothelialization is incomplete, and the problem of poor sealing performance occurs.

SUMMARY OF THE INVENTION

In view of this, the present application provides a plugging device and a plugging system to solve the problem of too slow endothelialization due to the large gap between the membrane and the support frame.

In a first aspect, an embodiment of the present application provides a blocking device, the blocking device is used to block a gap in tissue, and the blocking device includes:

a support frame, the support frame is used to be released at the gap, and the peripheral edge of the support frame is used to cover the peripheral tissue of the gap;

A covering film covers at least one side of the support frame, and at least part of the covering film is seamlessly connected with the support frame.

In some embodiments, the coating is directly formed on the support frame by electrospinning, dipping or spraying; or,

The coating is formed by electrospinning, dipping, spraying, tape casting or weaving, and the formed coating is fixed on the support frame by hot pressing or bonding.

In some embodiments, the support frame includes an outer side away from the notch and an inner side facing the notch, and the coating film covers the inner side of the support frame; or, covers the outer side of the support frame ; or, covering the inner and outer sides of the support frame.

In some embodiments, the material of the film includes a non-degradable material, and the non-degradable material includes polyethylene terephthalate, polytetrafluoroethylene, thermoplastic polyurethane elastomer rubber, silicone rubber, polyurethane, poly At least one of vinyl alcohol, hydrogel, expanded polytetrafluoroethylene, polyethylene, high density polyethylene, polyethylene terephthalate.

In some embodiments, the thickness of the coating is 0.01-0.2 mm.

In some embodiments, the material of the coating includes a degradable material, and the degradable material includes polylactic acid, polycaprolactone, polybutylene succinate, 1,3-propylene glycol and poly(L- At least one of lactide-co-ε-caprolactone) series copolymers.

In some embodiments, the thickness of the coating is 0.001mm-0.1mm.

In some embodiments, the support frame is configured as a mesh structure, and the mesh structure includes an edge segment and a plurality of intermediate segments connecting the edge segments, and the multiple intermediate segments are located in the area surrounded by the edge segments. In the region, the cover film is seamlessly connected to the edge segments and optionally to the plurality of intermediate segments.

In some embodiments, the material of the support framework includes at least one of a degradable material and a non-degradable material.

In some embodiments, a portion of the structure of the support frame is made of the degradable material and the rest of the structure of the support frame is made of a non-degradable material.

In some embodiments, the intermediate section includes a plurality of first sections and a plurality of second sections, the edge section and the plurality of first sections are made of a non-degradable material, and the second plurality of sections are made of Made of degradable materials.

In some embodiments, the edge segment encloses the first segment and the second segment to form a plurality of first meshes; the edge segment encloses the first segment to form a plurality of second meshes The size of at least one of the second mesh holes is larger than the size of one of the first mesh holes.

In some embodiments, a first connection point is formed at the intersection of each of the intermediate segments and the edge segment, and a second connection point is formed at the intersection of each of the first segments and the corresponding second segment, The cover film and the support frame are seamlessly connected at the positions of the first connection point and the second connection point.

In some embodiments, the cover film is seamlessly connected to the edge segments and all of the intermediate segments.

In some embodiments, the support frame and the covering film constitute a blocking disk, the blocking disk includes a first blocking disk and a second blocking disk, and the blocking device further comprises connecting the first blocking disk Pulling members of the blocking disk and the second blocking disk, the first blocking disk and the second blocking disk are respectively used to block one side of the gap, and the pulling member is used to block one side of the gap. The distance between the first occluding disc and the second occluding disc is adjusted.

In some embodiments, the first occlusion disc is located at the distal end of the second occlusion disc, a plurality of connecting rings are provided on the first occlusion disc, and the pulling member passes through the plurality of connection rings. a plurality of connecting rings, so as to realize the connection between the pulling member and the first sealing disc; the plurality of connecting rings include a plurality of first connecting rings located outside the geometric center of the first sealing disc, the Perforations are formed on the covering film of the first blocking disc, and the plurality of first connecting rings pass through the perforations and are fixed on the support frame of the first blocking disc.

In some embodiments, a filling body is provided in the through hole, so that the first connecting ring is sealedly connected with the covering film of the first sealing disc.

In some embodiments, the filling body is filled in the perforations by electrospinning, dipping or spraying.

In some embodiments, the plurality of connecting rings include a second connecting ring located at the geometric center of the first occlusion disc, the second connecting ring being fixed to the support frame.

In a second aspect, embodiments of the present application provide an occlusion system, including a conveyor and the occlusion device as described above, where the conveyor is used to deliver the occlusion device to the gap.

The occlusion device and occlusion system provided by the embodiments of the present application are based on covering at least one side of the support frame with a covering film, at least part of the covering film is seamlessly connected with the support frame, and the tissue can move from the edge of the occlusion device to the support frame. Climbing in the axial direction, thereby reducing the surface area of the plugging device that needs to be endothelialized, and also improving the connection strength between the coating and the supporting skeleton, reducing the distance between the coating and the supporting skeleton during the endothelialization process. The ratio and possibility avoid the situation that the local endothelialization of the occlusion device is better and the local endothelialization rate is slow, and it is not easy to form complications such as thrombosis, inflammatory reaction and endothelial hyperplasia, which is beneficial to improve the rate of endothelialization of the occlusion device. .

Description of drawings

In order to more clearly illustrate the embodiments of the present application or the technical solutions in the prior art, the following briefly introduces the accompanying drawings that are used in the description of the embodiments or the prior art. Obviously, the drawings in the following description are only These are some embodiments of the present application, and for those of ordinary skill in the art, other drawings can also be obtained from these drawings without any creative effort.

FIG. 1 is a schematic structural diagram of a plugging system provided by an embodiment of the present application.

FIG. 2 is a schematic structural diagram of a first embodiment of the plugging disc of the plugging device of the plugging system in FIG. 1 .

FIG. 3 is a schematic structural diagram of the support frame of the plugging device of the plugging system in FIG. 2 .

FIG. 4 is a schematic structural diagram of a second embodiment of the plugging disc of the plugging device of the plugging system in FIG. 1 .

FIG. 5 is a schematic structural diagram of the first state of the support frame of the plugging device of the plugging system in FIG. 4 .

FIG. 6 is a schematic structural diagram of the second state of the support frame of the plugging device of the plugging system in FIG. 4 .

FIG. 7 is a schematic structural diagram of another embodiment of the plugging device of the plugging system in FIG. 1 .

FIG. 8 is a schematic view of the inner side structure of the first plugging disc of the plugging device of the plugging system in FIG. 7 .

Description of main component symbols

Closure system 1000

Blocking device 100, 100a

Support frame 101, 101a

Central meeting point 1011

First mesh 1012

Second mesh 1013

Edge segment 102

middle section 104

First paragraph 1041

Second paragraph 1042, 1042a

Lamination 103

Perforated 1031

Blocking disc 105, 105a

Support ring 111

Intersection 113

first connection point 1131

Second connection point 1132

end connection section 114

first plug disc 11

Second plugging disc 13

connecting ring 12

first connecting ring 121

Threading hole 1211

Second connecting ring 122

Connector 14

Puller 15

Adjust the knot 150

Conveyor 200

Sheath 201

control handle 202

The following specific embodiments will further illustrate the present application in conjunction with the above drawings.

Detailed ways

The technical solutions in the embodiments of the present application will be clearly and completely described below with reference to the drawings in the embodiments of the present application. Obviously, the described embodiments are only a part of the embodiments of the present application, but not all of the embodiments. Based on the embodiments in the present application, all other embodiments obtained by those of ordinary skill in the art without creative work fall within the protection scope of the present application.

First of all, it should be noted that, in the field of interventional medicine, along the delivery path of the instrument, the end of the instrument close to the operator is usually referred to as the proximal end, and the end of the instrument away from the operator is referred to as the distal end. Specifically, with respect to a delivery device used to deliver and release an implantable device into a patient, the distal end refers to the end of the delivery device that can be freely inserted into an animal or human body, and the proximal end refers to the delivery device for a user or machine one end of the operation.

It is to be understood that the terms in the description and claims of the present application and the above drawings are only for describing specific embodiments, and are not intended to limit the present application. The terms "first", "second" and the like in the description and claims of the present application and the above drawings are used to distinguish different objects, rather than to describe a specific order. The singular forms "a" and "the" are intended to include the plural forms as well, unless the context clearly dictates otherwise. The term "comprising" and any variations thereof are intended to cover non-exclusive inclusion. In addition, the present application can be implemented in many different forms, and is not limited to the embodiments described in this embodiment. The following specific embodiments are provided for the purpose of facilitating a clearer and more comprehensible understanding of the disclosure of the present application, wherein the words indicating orientation, such as up, down, left, and right, are only for the positions of the structures shown in the corresponding drawings.

Subsequent descriptions in the specification are preferred embodiments for implementing the present application, however, the above descriptions are for the purpose of illustrating the general principles of the present application and are not intended to limit the scope of the present application. The scope of protection of this application should be determined by the appended claims.

Please refer to FIG. 1 . FIG. 1 is a schematic structural diagram of a plugging system 1000 according to an embodiment of the present application. The occlusion system 1000 includes the conveyor 200 and the occlusion device 100 . The occlusion device 100 is used to close a gap in the tissue to be occluded. The delivery device 200 is used to deliver and release the occlusion device 100 to the gap. The gap in the tissue to be occluded is, for example, but not limited to, a tissue defect site in the vasculature. The breach includes, but is not limited to, the foramen ovale, ductus arteriosus, atrial septum, interventricular septum, and the like. For example, the occlusion device 100 may be, but is not limited to, a left atrial appendage occlusion device, a PFO occlusion device, an atrial septal occlusion device, a ventricular septal occlusion device, or the like. It should be noted that, in this application, the gap is the foramen ovale as an example to illustrate the advantages of the closure system 1000 for treating patent foramen ovale. It can be understood that, the gap can also be other tissue defect sites mentioned above.

Specifically, in this embodiment, the delivery device 200 includes a sheath tube 201 for accommodating the occlusion device 100 and a control handle 202 fixed to the proximal end of the sheath tube 201 . The control handle 202 is used to control the occlusion device 100 to extend out of the sheath tube 201 and release to the gap; or, to control the occlusion device 100 to be retracted into the sheath tube 201 .

It should be understood by those skilled in the art that the above-described FIG. 1 is only an example of the occlusion system 1000, and does not constitute a limitation to the occlusion system 1000, and the occlusion system 1000 may include more or less than that shown in FIG. 1 . components, or a combination of certain components, or different components, for example, the occlusion system 1000 may also include a locator, a sensor, and the like.

The occlusion device 100 is used to close gaps in tissue. The occlusion device 100 includes a support frame 101 and a membrane 103 . The support frame 101 is used to release at the gap, the circumferential edge of the support frame 101 is used to cover the peripheral tissue of the gap, and the axial position of the support frame 101 is not used to contact the peripheral tissue of the gap, and is used for sealing in the gap, that is, for sealing in the channel surrounded by the tissue around the gap. The occlusion device 100 provided by the embodiment of the present application is based on covering the membrane 103 on at least one side of the support skeleton 101 , at least part of the membrane 103 is seamlessly connected with the support skeleton 101 , and the tissue can be removed from the edge of the occlusion device 100 Climbing in the direction of its axis, thereby reducing the surface area of the plugging device 100 that needs to be endothelialized, and also improving the connection strength between the film 103 and the support frame 101, reducing the thickness of the film 103 and the support frame 101. The ratio and possibility of detachment from each other during the process of endothelialization avoids the situation that the local endothelialization of the occlusion device 100 is better and the local endothelialization speed is slower, and it is not easy to form complications such as thrombosis, inflammatory reaction and endothelial hyperplasia, which is beneficial to The rate of endothelialization of the occlusion device 100 is increased.

In some embodiments, the coating 103 is directly formed on the support frame 101 by electrospinning, dipping or spraying, so that the coating 103 can be tightly formed on the outer surface of the supporting frame 101, that is, the coating 103 It is coated on the surface of the support frame 101 to realize the seamless connection between the film 103 and the support frame 101 . In other embodiments, the coating 103 is formed by electrospinning, dipping, spraying, tape casting or weaving, and the formed coating is fixed on the support frame 101 by hot pressing or bonding , so that the cover film 103 can be attached to the outer surface of the support frame 101 , so as to reduce the generation of gaps at the connection between the support frame 101 and the cover film 103 .

Preferably, in this embodiment, the coating 103 is formed on the support skeleton 101 by electrospinning, so as to obtain the coating 103 with larger porosity, so that the cells can better infiltrate the interior of the coating 103, which is beneficial to Cell crawl and endothelialization enable better integration of tissue and cells.

In this embodiment, the blocking device 100 includes two blocking disks, which are a first blocking disk 11 and a second blocking disk 13 respectively. The structures of the first plugging disc 11 and the second plugging disc 13 are similar. Both plugging discs include the above-mentioned supporting frame 101 and a covering film 103. The covering film 103 covers at least one side of the corresponding supporting frame 101, and the covering film At least part of the 103 is seamlessly connected with the corresponding support frame 101 . In a modified embodiment, one of the two blocking disks includes the above-mentioned support frame 101 and a cover film 103 , the cover film 103 covers at least one side of the support frame 101 , and at least part of the cover film 103 is connected to the support frame 103 . The skeletons 101 are seamlessly connected; the other of the two occluding discs only includes the supporting skeleton 101, that is, the covering film 103 is omitted.

In this embodiment, the first plugging disc 11 and the second plugging disc 13 are both in the shape of a single-layer disc surface, that is, in the axial direction, the support frame 101 forms a single-layer mesh surface structure. The first occlusion disc 11 and the second occlusion disc 13 are used to attach to the peripheral tissues on both sides of the notch on both sides of the notch. In a modified embodiment, any one of the first blocking disk 11 and the second blocking disk 13 can adopt a double-layer mesh disk structure, that is, the support frame 101 forms a double-layer mesh surface structure in the axial direction.

The support frame 101 includes an outer side facing away from the notch and an inner side facing the notch. In some embodiments, the film 103 is coated on the inner side of the support frame 101; or, the film 103 is coated on the outside of the support frame 101, so as to block blood flow. In other embodiments, the film 103 is covered on the inside and outside of the support frame 101, so that the film 103 and the support frame 101 are completely integrated, which is more conducive to the adhesion of the entire disk surface of the occlusion device 100 to the tissue, and the cells The effect of endothelialization is better, and the rate of endothelialization is faster.

Optionally, in this embodiment, the material of the covering film 103 includes a degradable material. The degradable materials include, but are not limited to, polylactic acid (PLA), polycaprolactone (PCL), polybutylene succinate (PBS), 1,3- At least one of propylene glycol (Propanediol, PDO) and poly(L-lactide-co-ε-caprolactone) series copolymers. In this way, by using the covering film 103 made of degradable material in the plugging device 100 of the present application, it is beneficial to improve the biocompatibility of the plugging device 100. The covering film 103 will gradually degrade after a certain period of use, and finally It becomes water and carbon dioxide that are easily absorbed and metabolized by the human body, thereby helping to reduce the stimulation to the human body, thereby reducing the long-term complication rate of long-term indwelling of the blocking device 100 . Optionally, in order to take into account the strength of the cover film 103 and the degradation degree of the cover film 103, when the cover film 103 is made of degradable materials, the thickness of the cover film 103 is 0.001mm-0.1mm, so as to ensure that the cover film 103 has a certain While maintaining the strength, it is ensured that the covering film 103 can be easily degraded in vivo.

In some embodiments, the material of the cover film 103 includes a non-degradable material. The non-degradable materials include, but are not limited to, polyethylene terephthalate (PET), polytetrafluoroethylene (PTFE), thermoplastic polyurethane elastomers (TPU), silicon Rubber, hydrogel, polyurethane (Polyurethane, PU), polyvinyl alcohol (Polyvinylalcohol, PVA), expanded polytetrafluoroethylene (Expanded Poly tetra fluoroethylene, expanded PTFE), polyethylene (Polyethene, PE), high density polyethylene ( At least one of high density polyethylene (HDPE) and polyethylene terephthalate (Polyethylene glycol terephthalate, PET). When the cover film 103 is made of a non-degradable material, the thickness of the cover film 103 is approximately 0.01-0.2 mm. In this way, the thickness of the coating 103 should be as thin as possible while ensuring that the mechanical properties of the coating 103 are up to standard.

Please refer to FIG. 1 and FIG. 2 together. FIG. 2 is a schematic structural diagram of the first embodiment of the blocking disk 105 of the blocking device 100 of the blocking system 1000 in FIG. 1 . As shown in FIG. 2 , the support frame 101 and the covering film 103 constitute the blocking disk 105 .

The support frame 101 is constructed as a mesh structure. The support frame 101 can be woven by braided wires with shape memory effect to form a mesh structure; or, the support frame 101 can also cut at least one of a rod-shaped structure, a tubular structure and a plate-shaped structure with a shape memory effect to form a mesh like structure. The mesh structure includes edge segments 102 and a plurality of intermediate segments 104 connecting the edge segments 102 . A plurality of intermediate segments 104 are located within the area enclosed by the edge segments 102 . In this embodiment, the support frame 101 may be made of degradable and/or degradable materials.

The cover film 103 is seamlessly connected to the edge segment 102 and optionally to a plurality of intermediate segments 104 . In some embodiments, the covering film 103 is seamlessly connected with the edge section 102 and all the middle sections 104 , which not only enhances the reliability and stability of the connection between the support frame 101 and the covering film 103 , but also helps to improve the biological properties of the occlusion device 100 . Compatibility and endothelialization rate, it is not easy to form thrombus, inflammatory reaction and endothelial hyperplasia and other complications, and the blocking effect is better.

In some embodiments, the cover film 103 may be seamlessly connected to at least a portion of the edge segment 102, for example, the cover film 103 may be seamlessly connected to the edge segment 102 through some adhesive points or thermal pressure points; alternatively, the cover film 103 may also It is directly connected to the entirety of the edge segment 102 seamlessly. In this embodiment, the covering film 103 may not be fixedly connected with the middle section 104; alternatively, the covering film 103 may also be seamlessly connected with at least part of the middle section 104, for example, by bonding or hot pressing to achieve seamless connection Alternatively, the film 103 can also be connected with the middle section 104 by means of sewing or the like with a gap.

In some embodiments, the cover film 103 may be seamlessly connected with at least part of the middle section 104 , for example, the cover film 103 may be seamlessly connected with the middle section 104 through some bonding points or thermal pressure points, or directly with the middle section 104 . All connected seamlessly. In this embodiment, the cover film 103 may not be fixedly connected to the edge segment 102; alternatively, the cover film 103 may also be seamlessly connected to at least part of the edge segment 102, for example, by means of bonding or heat pressing to achieve seamless connection Alternatively, the covering film 103 can also be connected with the edge segment 102 by means of sewing or the like with a gap.

As shown in FIG. 1 , the radial dimension of the film 103 is larger than that of the support frame 101 , that is, the circumferential edge of the film 103 exceeds the edge segment 102 of the support frame 101 , and the circumferential edge of the film 103 is a free edge , not fixed on the support frame 101 . In some embodiments, such as shown in FIG. 2 , the circumferential edge of the film 103 is flush with the circumferential edge of the support frame 101 , and the circumferential edge of the film 103 is fixed on the circumferential edge of the support frame 101 . Please refer to FIG. 2 and FIG. 3 together. FIG. 3 is a schematic structural diagram of the support frame 101 of the blocking disk 105 in FIG. 2 . As shown in FIG. 3 , the entire structure of the support frame 101 is made of the same material. Specifically, the material of the support frame 101 includes a metal material having biocompatibility, thereby enhancing the overall strength of the support frame 101 . In this embodiment, all the structures of the support frame 101 are made of metal materials. In some embodiments, the material of the support framework 101 includes a non-degradable metal material. The non-degradable metal material includes, but is not limited to, at least one of stainless steel, tungsten alloy, cobalt-based alloy, and nickel-titanium alloy. In some other embodiments, the material of the support frame 101 includes a degradable metal material. Degradable metal materials include, but are not limited to, at least one of magnesium alloys, iron alloys, or zinc alloys. In some embodiments, the material of the support skeleton 101 may also include or further include at least one of high molecular polymer materials, non-degradable non-metallic materials, degradable non-metallic materials, or any combination thereof.

The support frame 101 is constructed as a mesh structure. The support frame 101 can be woven by braided wires with shape memory effect to form a mesh structure; or, the support frame 101 can also cut at least one of a rod-shaped structure, a tubular structure and a plate-shaped structure with a shape memory effect to form a mesh like structure. The mesh structure includes edge segments 102 and a plurality of intermediate segments 104 connecting the edge segments 102 . A plurality of intermediate segments 104 are located within the area enclosed by the edge segments 102 . Wherein, the edge segments 102 are jointly enclosed to form a closed area. Each intermediate segment 104 is configured in an arcuate configuration. In some embodiments, the intermediate section may also exhibit a rectilinear configuration.

Specifically, the support frame 101 has a convergence point 1011 . The network structure is formed by a plurality of support rings 111 arranged in a cross radial pattern. A plurality of support rings 111 are arranged in the circumferential direction from the convergence point 1011 of the mesh structure. In this embodiment, the number of the support rings 111 is six, and the six support rings 111 are arranged in a clockwise direction or a counterclockwise direction along the circumferential direction and are cross-connected. In other embodiments, the number of support rings 111 can also be 5, 8 or other numbers, which can be set according to actual needs. Adjacency setting or interval setting. Each support ring 111 may have, but is not limited to, an ellipse, a semicircle, a petal shape, an irregular shape, and the like. Each support ring 111 includes a circumferential segment 106 and two intermediate segments 104 correspondingly connected to opposite ends of the circumferential segment 106 . Each intermediate segment 104 extends along the radial direction of the circumferential segment 106 and converges at the convergence point 1011 , thereby enhancing the reliability and stability of the connection between the support frame 101 and the covering film 103 , thereby improving the blocking of the blocking device 100 Effect. Each circumferential segment 106 extends along the circumference of the mesh structure, and all the circumferential segments 106 are connected end to end to form the edge segment 102 .

The plurality of intermediate segments 104 includes a first segment 1041 and a second segment 1042 . The first ends of the first section 1041 and the second section 1042 are both relatively far away from the convergence point 1011 of the support frame 101 and are connected to the edge section 102 , and the second ends of the first section 1041 and the second section 1042 are opposite to the first end Close to the convergence point 1011 of the support frame 101 . In this embodiment, the material of the first section 1041 and the material of the second section 1042 are the same, and both are made of metal material.

In some embodiments, the connection between any two adjacent support rings 111 , that is, the connection between the edge segment 102 and the middle segment 104 and the connection between any two adjacent middle segments 104, can be performed by welding, interpenetration and/or or twisted and knotted together. The middle section 104 and the circumferential section 106 of each support ring 111 may both include a plurality of metal braided wires, or both may be cut from a whole metal tube, or may be mixed and matched. Specifically, in some embodiments, when the middle section 104 is directly cut and formed from a whole metal tube, the edge section 102 includes a plurality of metal braided wires, and the middle section 104 is welded to the inner circumference and/or the outer circumference of the edge section 102 .

In other embodiments, any two adjacent support rings 111 are cross-connected to each other. Specifically, when each support ring 111 includes a plurality of metal braided wires, a gap is formed between the plurality of metal braided wires. The middle section 104 of one of the support rings 111 is inserted into the gap of the adjacent middle section 104 of the other support ring 111 ; the circumferential section 106 of one of the support rings 111 is inserted into the other adjacent support ring 111 in the gap of the circumferential segment 106, and optionally welded at the intersection of the two to improve the connection strength.

In some embodiments, the edge section 102 includes a plurality of metal braided wires and is woven into a whole by the plurality of metal braided wires, and the middle section 104 includes a plurality of metal braided wires. In such an embodiment, the middle segment 104 is inserted into the slit of the edge segment 102 ; alternatively, the edge segment 102 is inserted into the slit of the intermediate segment 104 . In other embodiments, the edge segment 102 includes a plurality of metal braided wires, which are braided to form a whole, the intermediate segment 104 is directly cut and formed from a metal tube, and the intermediate segment 104 is inserted through the gap of the edge segment 102. middle. In some other embodiments, the edge segment 102 is directly cut and formed from a metal tube, the middle segment 104 includes a plurality of metal braided wires, and the edge segment 102 is inserted into the gap of the middle segment 104 .

Please refer to FIG. 4 , which is a schematic structural diagram of a second embodiment of the blocking disk 105 a of the blocking device 100 a in FIG. 1 . As shown in FIG. 4 , the support frame 101a and the coating film 103 constitute a plugging disc 105a. The main difference between the support frame 101a provided in this embodiment and the support frame 101 provided in the first embodiment is that in this embodiment, the material of the edge section 102 is the same as the material of the first section 1041, and the material of the first section 1041 The material of the second section 1042a may be different; in addition, the cover film 103 is seamlessly connected with the edge section 102 and the first section 1041 .

Every two adjacent support rings 111 are cross-connected, and two adjacent support rings 111 cross each other to form one or more intersections 113 . The plurality of intersections 113 include a plurality of first connection points 1131 and a plurality of second connection points 1132 . In this embodiment, a first connection point 1131 is formed at the intersection of the edge segment 102 and each intermediate segment 104, and a second connection point is formed at the intersection of each first segment 1041 and the corresponding second segment 1042a 1132. The plurality of first connection points 1131 are relatively far from the convergence point 1011 of the support frame 101 , and the plurality of second connection points 1132 are relatively close to the convergence point 1011 of the support frame 101 . Specifically, a plurality of first connection points 1131 are located on the edge segment 102 , and a plurality of second connection points 1132 are located between the first connection point 1131 and the convergence point 1011 . Optionally, the covering film 103 and the supporting frame 101 are seamlessly connected at positions corresponding to the first connection point 1131 and/or the second connection point 1132 .

Please refer to FIG. 4 and FIG. 5 together. FIG. 5 is a schematic structural diagram of the second embodiment in which the support frame 101 a of the blocking device 100 in FIG. 4 is in the first state. As shown in FIG. 5 , part of the structure of the support frame 101a is made of a first material, and another part of the structure is made of a second material, wherein the first material is different from the second material. Specifically, the material of the support frame 101a includes both biocompatible non-degradable materials and degradable materials, that is, part of the structure of the support frame 101a is made of non-degradable materials. In this embodiment, the non-degradable materials may be the above-mentioned non-degradable materials. Non-degradable metal material. Another part of the structure of the support frame 101a is made of degradable material. In the present application, degradable materials are added to the supporting framework 101a of the occlusion device 100, thereby reducing the release of metal ions, and the degradable framework will not remain in the body after being degraded, thereby reducing the incidence of complications. The degradable materials include degradable metal materials and/or the above-mentioned degradable non-metallic materials. Degradable non-metallic materials include, but are not limited to, polylactic acid, polycaprolactone, polybutylene succinate, 1,3-propanediol, and poly(L-lactide-co-ε-caprolactone) A copolymer or blend of one or at least two of a series of copolymers, polyglyconate, polyhydroxybutyrate, polyanhydride, and polyphosphoester.

As shown in FIG. 5, the material of the first section 1041 is different from the material of the second section 1042a. In this embodiment, the first section 1041 is made of non-degradable material, and the second section 1042a is made of degradable material. Preferably, the first section 1041 is made of a non-degradable metal material, and the second section 1042a is made of a degradable non-metallic material, so as to ensure the overall support strength of the support frame 101a and mechanical properties such as resilience, while reducing support The metal content of the skeleton 101a reduces the incidence of complications.

In this embodiment, the number of the first sections 1041 may be less than the number of the second sections 1042a, thereby reducing the risk of inflammatory reaction caused by the support frame 101a, which is beneficial to reduce the stimulation of the tissue to be blocked by the support frame 101a. Specifically, the plurality of first sections 1041 are evenly spaced, so that the overall strength of the support frame 101a can be ensured even after the second section 1042a is partially or completely degraded, and the phenomenon that the support frame 101a is deformed to reduce the blocking effect can be avoided. Optionally, the plurality of first sections 1041 are arranged symmetrically from the geometric center of the supporting frame 101a, so as to improve the uniformity of the force of the supporting frame 101a and better seal the tissue to be sealed. The plurality of first segments 1041 are connected with the edge segment 102 to form a whole, thereby enhancing the overall strength of the supporting frame 101a. In some embodiments, the number of the second segments 1042a may also be greater than the number of the second segments 1042a, thereby improving the overall strength of the support frame 101a and mechanical properties such as resilience. In other embodiments, in order to take into account the strength and biocompatibility of the support frame 101a, the number of the first sections 1041 may also be equal to the number of the second sections 1042a, and the plurality of first sections 1041 and the plurality of second sections 1042a are arranged alternately.

Please refer to FIG. 5 and FIG. 6 together. FIG. 6 is a schematic structural diagram of the second embodiment in which the support frame 101 a of the plugging device 100 in FIG. 4 is in a second state, wherein the first state refers to the support frame 101 The plurality of second segments 1042 of 104 are in a state before degradation; the second state refers to a state after the degradation of the plurality of second segments 1042 of the support skeleton 101 . It can be understood that before the plurality of second segments 1042 are degraded, the edge segment 102 and the first segment 1041 and the second segment 1042 are enclosed to form a plurality of first meshes 1012; after the plurality of second segments 1042 are degraded, the edge segment 102 A plurality of second mesh holes 1013 are formed by enclosing a plurality of first sections 1041, and the size of at least one second mesh hole 1013 is larger than that of a first mesh hole 1012, so as to facilitate the subsequent endothelialization of the plugging device 100, it can be The tissue to be treated (eg atrial septum) is punctured at the position of the second mesh hole 1013 . Optionally, when the materials of the second segment 1042a and the covering film 103 are both degradable materials, the puncturing operation is more convenient. The shapes and sizes of the plurality of first mesh holes 1012 may be the same or different. In this embodiment, the shapes of the plurality of first mesh holes 1012 are partially the same, and the other parts are different. Specifically, in the circumferential direction of the support frame 101, any two adjacent first mesh holes 1012 have the same shape and size. In the radial direction of the support frame 101, any two adjacent first mesh holes 1012 have different shapes and sizes. The shape and size of the plurality of second mesh holes 1013 are the same, and the area of each second mesh hole 1013 is larger than that of any one of the first mesh holes 1012 .

Please refer to FIG. 7 , which is a schematic structural diagram of another embodiment of the blocking device 100 a of the blocking system 1000 in FIG. 1 . In this embodiment, the structure of the blocking device 100a is similar to that of the blocking device 100a of the first embodiment. The difference is that the circumferential edge of the film 103 is flush with the circumferential edge of the support frame 101 , and the circumferential edge of the film 103 is fixed on the circumferential edge of the support frame 101 .

Please refer to FIG. 1 and FIGS. 7 to 8 together. FIG. 8 is a schematic diagram of the inner side structure of the first plugging disc 11 in the plugging device 100 a of the plugging system 1000 in FIG. 7 . In this embodiment, every two adjacent support rings 111 are cross-connected, and two adjacent support rings 111 cross each other to form one or more intersections 113 . The multiple intersection points of the support ring 111 only include multiple first connection points 1131 , that is, a first connection point 1131 is formed at the intersection of each intermediate segment 104 and the edge segment 102 , and any two adjacent intermediate segments 104 are far away from each other. One end of the edge segment 102 is formed with an end connecting segment 114, so as to ensure the overall support strength of the support frame 101 and mechanical properties such as resilience. Optionally, the covering film 103 and the supporting frame 101 are seamlessly connected at positions corresponding to the first connection point 1131 and/or the plurality of end connection segments 114 . As shown in FIG. 1 , in some embodiments, each intermediate segment 104 is formed with an end connecting segment at one end away from the edge segment 102 , and any two adjacent connecting segments are arranged at intervals.

In this embodiment, the blocking device 100 a includes a first blocking disk 11 and a second blocking disk 13 . The occlusion device 100a further includes a pulling member 15 connecting the first occlusion disc 11 and the second occlusion disc 13 . Both the first occlusion disc 11 and the second occlusion disc 13 are used to close the gap, that is, the first occlusion disc 11 and the second occlusion disc 13 are respectively used to cover one side of the occlusion in the tissue. The pulling member 15 is used to adjust the distance between the first blocking disk 11 and the second blocking disk 13 .

Specifically, the first blocking disk 11 is located at the distal end of the second blocking disk 13 , a plurality of connecting rings 12 are provided on the first blocking disk 11 , and the pulling member 15 passes through the plurality of connecting rings 12 . Each connecting ring 12 includes a plurality of first connecting rings 121 located outside the geometric center of the first plugging disc 11 , a through hole 1031 is formed on the covering film 103 of the first plugging disc 11 , and the plurality of first connecting rings 121 pass through The perforations 1031 are fixed on the support frame 101 of the first blocking disc 11 , preferably, inserted into the gaps formed between the plurality of metal braided wires on the support frame 101 (refer to the above-mentioned embodiment, which will not be repeated here). The pulling member 15 passes through the plurality of connecting rings 12 to realize the connection between the pulling member 15 and the first blocking disc 11 .

The first connecting ring 121 is annular and forms a threading hole 1211 , and the pulling member 15 passes through the threading hole 1211 of the first connecting ring 121 . When the pulling member 15 is tightened, the pulling member 15 can slide in the first connecting ring 121, thereby assisting in adjusting the length of the pulling member 15 between the first blocking disc 11 and the second blocking disc 13, and further The distance between the first blocking disk 11 and the second blocking disk 13 is adjusted. The plurality of first connecting rings 121 can be fixed on the first blocking disc 11 by means of bonding, knotting or the like.

Optionally, a filler is provided in the perforation 1031, so that the first connection ring 121 is sealedly connected to the membrane 103 of the first occlusion disc 11, thereby further reducing the surface area of the occlusion device 100a that needs to be endothelialized, and the tissue Climbing from the edge of the occlusion device 100a to the axis direction is beneficial to improve the biocompatibility and endothelialization rate of the occlusion device 100a, and is not prone to complications such as thrombosis, inflammatory reaction and endothelial hyperplasia. The filling body can be, but is not limited to, be filled in the through holes 1031 by electrospinning, dipping or spraying. It can be understood that the material of the coating film 103 is suitable for the material of the filling body, and the material of the filling body can also be other materials with biological identity.

Both ends of the pulling member 15 pass through the second blocking disk 13 and form an adjusting wire knot 150 on the side of the second blocking disk 13 away from the first blocking disk 11 . The spacing between the discs 13 can be adjusted by adjusting the ends of the pullers 15 to suit the needs of different patients and different tissue anatomies. The shapes of the disk surfaces of the first plugging disk 11 and the second plugging disk 13 can be set to be circular, polygonal, elliptical, triangular or other irregular shapes, and the radial dimension of the first plugging disk 11 is the same as that of the second plugging disk. The radial dimension of the 13 may be the same or different, for example, the radial dimension of the first plugging disc 11 is smaller than the radial dimension of the second plugging disc 13 . In this embodiment, both the first blocking disk 11 and the second blocking disk 13 are substantially hexagonal disks, and the radial dimension of the first blocking disk 11 is equal to the radial size of the second blocking disk 13 . The structure of the second blocking disk 13 is similar to that of the first blocking disk 11 , the difference is that a plurality of connecting rings are not provided on the second blocking disk 13 . The structure of the first blocking disk 11 will be described in detail below.

In this embodiment, in the second plugging disc 13 and the first plugging disc 11 , each support ring 111 is formed by winding or arranging a plurality of braided wires, that is, all the support rings 111 are made of a plurality of braids. The filaments are wound and woven to form a disc-like structure, so that the first occlusion disc 11 and the second occlusion disc 13 have strong flexibility and mechanical strength, and can fully adhere to the surface of the tissue to be occluded. The support frame 101 of the first plugging disc 11 and the support frame 101 of the second plugging disc 13 are respectively a single-layer woven mesh structure, a single-layer cutting frame structure, a double-layer woven mesh structure or a double-layer cutting frame structure. any kind. In this embodiment, the supporting frame 101 of the first blocking disk 11 and the supporting frame 101 of the second blocking disk 13 are both single-layer woven mesh structures.

It can be understood that, in some embodiments, some of the support rings 111 in the first occlusion disc 11 include a plurality of braided wires, and other support rings 111 in the first occlusion disc 11 include one braided wire. In some embodiments, the support frame 101 can also be laser-cut from a plate/tubular nickel-titanium alloy to form a disk-shaped structure with a hollowed-out structure, thereby enhancing the supportability of the support frame 101 .

In the first blocking disc 11 , the plurality of connecting rings 12 further include second connecting rings 122 , the blocking device 100 a further includes connecting pieces 14 , and the second connecting rings 122 are connected to the support frame 101 through the connecting pieces 14 . The connecting piece 14 is arranged in the geometric center of the first closing disk 11 . In other embodiments, the connecting piece 14 is provided at an eccentric position on the first blocking disc 11 . Specifically, the plurality of support rings 111 of the support frame 101 are arranged around the circumference of the connecting member 14 . Preferably, the support rings 111 on the first blocking disc 11 are evenly spaced. The second connecting ring 122 is wound on the connecting piece 14 , so that the second connecting ring 122 is approximately located at the geometric center of the first plugging disc 11 . Optionally, a plurality of support rings 111 are circumferentially arranged around the connecting member 14 at least once to form a single-layer or multi-layer network structure.

The connector 14 and the support frame 101 may be integrally formed; or may be fixedly connected together by welding, bonding, or the like. The connecting piece 14 can be a steel sleeve with both ends open, and the connecting piece 14 can also be a combination of multi-layer steel sleeves. The ends of the plurality of support rings 111 are connected to the outer peripheral surface of the connecting member 14 , and are fixedly connected to the outer peripheral surface of the connecting member 14 by welding or bonding. The material of the connector 14 includes, but is not limited to, stainless steel, Nitinol or other biocompatible materials.

The second connecting ring 122 can be fixed on the connecting member 14 by means of gluing, knotting, etc., so as to prevent the second connecting ring 122 from being displaced. The first connecting ring 121 is arranged around the circumference of the second connecting ring 122 . The number of the first connecting ring 121 and the number of the second connecting ring 122 may include one or more. In this embodiment, the number of the first connection rings 121 includes a plurality, and the number of the second connection rings 122 includes one. Preferably, the plurality of first connecting rings 121 are evenly arranged around the second connecting ring 122 for at least one circle, so as to improve the uniformity of the force on the first blocking disc 11 during the process of taking up and paying out the wire of the pulling member 15 . In some embodiments, the plurality of first connecting rings 121 are evenly spaced. The second connecting ring 122 is annular and forms a threading hole, and the pulling member 15 is passed through the threading hole of the first connecting ring 121 and the threading hole of the second connecting ring 122 .

Preferably, the second connecting ring 122 is arranged at the geometric center of the first blocking disc 11 , the pulling member 15 passes through the threading hole of the second connecting ring 122 and is tightened, and the second connecting ring 122 is connected to the pulling member 15 . The intersection is located on the geometric center of the first blocking disk 11, so that the first blocking disk 11 is subjected to uniform tension. When the first blocking disk 11 is positioned and the length of the pulling member 15 is adjusted, the first blocking disk 11 Not prone to skew.

The connecting ring 12 and the pulling member 15 can optionally be non-absorbable biocompatible sutures, such as metal threads, cotton threads, polyester, polypropylene, and the like. The connecting ring 12 and the pulling member 15 can also be selected from absorbable biocompatible sutures, such as catgut, polyglycolide, multifilament non-biodegradable sutures, etc. The pulling member 15 can also be selected from forced winding fibers line etc.

In this embodiment, the material of the connecting ring 12 includes, but is not limited to, at least one of polypropylene, polyethylene terephthalate, and polytetrafluoroethylene. The material of the pulling member 15 includes, but is not limited to, at least one of polytetrafluoroethylene, polyglycolide, polyglycolide, polylactic acid, collagen, nylon suture, and polyester suture. Preferably, the pulling member 15 is a suture made of polytetrafluoroethylene. Due to the high mechanical strength of the polytetrafluoroethylene material, the toughness of the pulling member 15 is improved. Preferably, the material of the connecting ring 12 is polypropylene with better tensile strength and hardness. The connection ring 12 adopts a double-strand suture, so that the occlusion device 100a has better connection strength. In other embodiments, the connecting ring 12 may also employ more strands of suture, or one strand of suture.

Please refer to FIGS. 1 to 8 together. During use, the first occluding disc 11 is delivered from the left atrium and deployed in the left atrium by the delivery device 200 , and the second occluding disc 13 is delivered by the delivery device 200 . Delivered to and deployed in the right atrium. The pulling member 15 connected between the first occlusion disc 11 and the second occlusion disc 13 has flexibility and can be adjusted in length, and the pulling member 15 penetrates through the foramen ovale between the primary diaphragm and the secondary diaphragm. Pull the free end of the pulling member 15 to the proximal end, the pulling member 15 is tightened, and the pulling member 15 is located on the geometric center of the first blocking disc 11, and the pulling member 15 is gradually shortened, that is, the first The distance between the blocking disk 11 and the second blocking disk 13 is gradually reduced, the primary diaphragm and the secondary diaphragm are close to each other and are clamped by the first blocking disk 11 and the second blocking disk 13. A sealing disc 11 covers the primary diaphragm and the secondary diaphragm around the foramen ovale, and the second sealing disc 13 covers the primary diaphragm and the secondary diaphragm around the foramen ovale, that is, the foramen ovale is on the left and right. The openings on both sides of the atrium are respectively covered by the first occlusion disc 11 and the second occlusion disc 13 . Since both the first occlusion disc 11 and the second occlusion disc 13 include a support frame 101 and a membrane 103 seamlessly connected to at least the support frame 101, the membranes 103 on both sides of the foramen ovale can prevent blood from flowing into the egg The round hole prevents blood flow from the left atrium to the right atrium, enabling instant closure. After the occlusion devices 100 and 100 are implanted, the primary diaphragm and the secondary diaphragm crawl to the contact position of the first occlusion disc 11 and the second occlusion disc 13 to close the foramen ovale after the completion of endothelialization, forming a Complete room divider.

The blocking device in the embodiment of the present application has a double blocking disk structure, and the two blocking disks are separated. In a modified embodiment, the blocking device may also be in the shape of a column, that is, the support frame is in the shape of a plunger, and the support frame encloses an inner cavity. The plugging device can also be in the form of an integrated double plugging disc structure with an integrally formed waist between the double plugging discs, or other regular or irregular shapes, and the specific structure of the plugging device is not limited. .

It can be understood that, the covering film can be set at a preset position on the support frame as required. The preset position may be the outer side surface of the support frame for contacting the tissue around the gap, or may be the inner cavity enclosed by the support frame.

It can be understood that, in some embodiments, the porosity of the membrane can be increased, so as to facilitate the infiltration of tissue cells into the membrane and facilitate the endothelialization of the support framework and the membrane.

The plugging device and the plugging system provided by the embodiments of the present application are based on the seamless connection of at least part of the covering film with the support skeleton, thereby reducing the surface area of the plugging device that needs to be endothelialized. The occluding tissue crawls from the edge of the occlusion device to the axis direction, which is beneficial to improve the rate of endothelialization of the occlusion device.

The embodiments of the present application are described in detail above, and specific examples are used in this paper to illustrate the principles and implementations of the present application. The descriptions of the above embodiments are only used to help understand the methods and core ideas of the present application; at the same time, for Persons of ordinary skill in the art, according to the idea of the present application, will have changes in the specific implementation manner and application scope. To sum up, the content of this specification should not be construed as a limitation to the present application.

Claims (20)

1. A blocking device, characterized in that, the blocking device is used to block a gap in tissue, and the blocking device comprises: a support frame, the support frame is used to be released at the gap, and the peripheral edge of the support frame is used to cover the peripheral tissue of the gap; A cover film covers at least one side of the support frame, and at least part of the cover film is seamlessly connected with the support frame. 2 . The plugging device according to claim 1 , wherein the coating film is directly formed on the support frame by an electrospinning method, a dipping method or a spraying method; or, 2 . The coating is formed by electrospinning, dipping, spraying, tape casting or weaving, and the formed coating is fixed on the support frame by hot pressing or bonding. 3 . The plugging device according to claim 1 , wherein the support frame includes an outer side away from the notch and an inner side facing the notch, and the coating film covers the inner side of the support frame; 4 . Or, it is covered on the outside of the support frame; or, it is covered on the inside and outside of the support frame. 4. The occlusion device according to claim 1, wherein the material of the film comprises non-degradable material, and the non-degradable material comprises polyethylene terephthalate, polytetrafluoroethylene, thermoplastic At least one of polyurethane elastomer rubber, silicone rubber, hydrogel, polyurethane, polyvinyl alcohol, expanded polytetrafluoroethylene, polyethylene, high density polyethylene, polyethylene terephthalate. 5 . The occlusion device according to claim 4 , wherein the thickness of the film is 0.01-0.2 mm. 6 . 6 . The plugging device according to claim 1 , wherein the material of the film comprises degradable materials, and the degradable materials comprise polylactic acid, polycaprolactone, polybutylene succinate , at least one of 1,3-propanediol and poly(L-lactide-co-ε-caprolactone) series copolymers. 7. The occlusion device according to claim 6, wherein the thickness of the film is 0.001mm-0.1mm. 8. The occlusion device according to claim 1, wherein the material of the support frame comprises at least one of a degradable material and a non-degradable material. 9. The occlusion device of claim 8, wherein a part of the structure of the support frame is made of the degradable material, and the rest of the structure of the support frame is made of a non-degradable material. 10. The occlusion device according to claim 8, wherein the support frame is configured as a mesh structure, and the mesh structure comprises an edge segment and a plurality of intermediate segments connecting the edge segments, the multiple An intermediate segment is located within the area enclosed by the edge segment, and the cover film is seamlessly connected to the edge segment and optionally to the multiple intermediate segments. 11. The occlusion device of claim 10, wherein the plurality of intermediate segments comprises a plurality of first segments and a plurality of second segments, and the edge segments and the plurality of first segments are composed of non- of degradable material, and the plurality of second segments are made of degradable material. 12. The occlusion device according to claim 11, wherein the edge segment and the first segment and the second segment enclose a plurality of first meshes; the edge segment and the multiple The first sections enclose a plurality of second mesh holes, and the size of at least one of the second mesh holes is larger than the size of one of the first mesh holes. 13. The occlusion device according to claim 10, wherein a first connection point is formed at the intersection of each of the intermediate segments and the edge segments, and each of the first segments and the corresponding second segment are formed with a first connection point. A second connection point is formed at the intersection of the segments, and the cover film is seamlessly connected to the support frame at the location of the first connection point and the second connection point. 14. The occlusion device of claim 10, wherein the covering film is seamlessly connected to the edge section and all the intermediate sections. 15. The plugging device according to any one of claims 1-14, wherein the support frame and the coating film constitute a plugging disk, and the plugging disk comprises a first plugging disk and a second plugging disk A plugging disc, the plugging device further comprises a pulling member connecting the first plugging disc and the second plugging disc, the first plugging disc and the second plugging disc are respectively used for One side of the gap is blocked, and the pulling member is used to adjust the distance between the first blocking disk and the second blocking disk. 16. The occlusion device according to claim 15, wherein the first occlusion disc is located at the distal end of the second occlusion disc, and a plurality of connection rings are provided on the first occlusion disc , the pulling member passes through the plurality of connecting rings, so as to realize the connection between the pulling member and the first plugging disc; the plurality of connecting rings include a geometric center located at the first plugging disc There are a plurality of first connecting rings outside, the covering film of the first blocking disk is provided with perforations, and the plurality of first connecting rings pass through the perforations and are fixed to the supporting frame of the first blocking disk superior. 17 . The occlusion device according to claim 16 , wherein a filling body is provided in the through hole, so that the first connecting ring is sealedly connected with the covering film of the first occlusion disc. 18 . 18. The plugging device according to claim 17, wherein the filling body is filled in the perforation by electrospinning, dipping or spraying. 19. The occlusion device of claim 16, wherein the plurality of connecting rings comprises a second connecting ring, the occluding device further comprises a connecting piece, the second connecting ring passing through the connecting piece fixed on the support frame. 20. An occlusion system, comprising a conveyor and the occlusion device according to any one of claims 1-19, wherein the conveyor is used to deliver the occlusion device to the gap.

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