CN114366183A

CN114366183A - Plugging device and plugging system

Info

Publication number: CN114366183A
Application number: CN202111604804.9A
Authority: CN
Inventors: 王永胜; 程晓阳; 赵江浪; 刘文静; 郑文韬
Original assignee: Hangzhou Dinova EP Technology Co Ltd
Current assignee: Hangzhou Dinova EP Technology Co Ltd
Priority date: 2021-12-24
Filing date: 2021-12-24
Publication date: 2022-04-19
Also published as: WO2023116837A1

Abstract

The application discloses plugging device and plugging system. The plugging device is used for plugging a gap in a tissue and comprises a supporting framework and a covering film. The supporting framework is used for being released at the gap, and the circumferential edge of the supporting framework is used for covering the peripheral tissues of the gap. The covering film covers at least one side of the supporting framework, and at least part of the covering film is in seamless connection with the supporting framework. By adopting the plugging device and the plugging system, based on covering the covering film on at least one side of the supporting framework, at least part of the covering film is in seamless connection with the supporting framework, so that the area of the surface of the plugging device needing endothelialization is reduced, the connection strength between the covering film and the supporting framework is improved, the possibility that the covering film and the supporting framework are separated from each other in the endothelialization process is reduced, the local endothelialization of the plugging device is prevented from being better, the local endothelialization speed is slow, complications such as thrombus, inflammatory reaction, endothelial hyperplasia and the like are not easy to form, and the endothelialization speed of the plugging device is favorably improved.

Description

Plugging device and plugging system

Technical Field

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

Background

The Foramen Ovale (Foramen Ovale) is a physiological channel of the heart at the interatrial interval embryonic period, and is generally closed within the first 1 year after birth, about 20-25% of adult patients have incomplete closure of the Foramen Ovale, and the patent of the Foramen Ovale is one of the most common congenital heart abnormalities in adults at present.

In recent years, Patent Oval Foramen (PFO) is closely related to ischemic stroke and migraine. PFO is thought to act as a "paradox embolus" from venous circulation, leading to stroke. There are a large number of clinical data that demonstrate that 10% to 40% of PFO is closely associated with the occurrence of stroke of unknown origin. At least 15-50 ten thousand stroke patients are caused by PFO in China every year. A series of researches show that the incidence rate of PFO of patients with unexplained cerebral apoplexy, which are under 55 years old, is about 47-56%.

At present, the PFO treatment modes mainly include drug treatment and PFO blockage (PFO blockage has obvious advantages compared with drugs).

However, in the patent foramen ovale plugging device in the prior art, the covering film is combined on the skeleton in a sewing and other fixing part fixing mode, so that the adhesion between the disc surface and the tissue to be plugged is poor, the endothelialization rate is too slow, the local endothelialization of the plugging device is obvious, partial endothelialization is incomplete, and the plugging performance is poor.

Disclosure of Invention

In view of this, the present application provides an occlusion device and an occlusion system to solve the problem of too slow endothelialization rate caused by a large gap between a covering membrane and a supporting framework.

In a first aspect, embodiments of the present application provide an occlusion device for occluding a gap in tissue, the occlusion device comprising:

a support armature for release at the gap, a circumferential edge of the support armature for covering tissue surrounding the gap;

and the covering film covers at least one side of the supporting framework, and at least part of the covering film is in seamless connection with the supporting framework.

In some embodiments, the coating is directly formed on the supporting skeleton by an electrostatic spinning method, a dipping method or a spraying method; alternatively, the first and second electrodes may be,

the coating is formed in an electrostatic spinning mode, a dipping mode, a spraying mode, a casting forming mode or a weaving mode, and the formed coating is fixed on the supporting framework in a hot pressing mode or an adhesion mode.

In some embodiments, the support skeleton comprises an outer side facing away from the gap and an inner side facing towards the gap, and the covering film covers the inner side of the support skeleton; or, the outer side of the supporting framework is coated; or the inner side and the outer side of the supporting framework are coated.

In some embodiments, the material of the cover film comprises a non-degradable material comprising at least one of polyethylene terephthalate, polytetrafluoroethylene, thermoplastic polyurethane elastomer rubber, silicone rubber, polyurethane, polyvinyl alcohol, hydrogel, expanded polytetrafluoroethylene, polyethylene, high density polyethylene, polyethylene terephthalate.

In some embodiments, the coating has a thickness of 0.01 to 0.2 mm.

In some embodiments, the material of the covering membrane comprises a degradable material comprising at least one of polylactic acid, polycaprolactone, polybutylene succinate, 1, 3-propanediol, and poly (L-lactide-co-e-caprolactone) series copolymers.

In some embodiments, the coating has a thickness of 0.001mm to 0.1 mm.

In some embodiments, the support frame is configured as a mesh structure including an edge segment and a plurality of intermediate segments connecting the edge segment, the plurality of intermediate segments being located within an area enclosed by the edge segment, the covering membrane being seamlessly connected with the edge segment and optionally the plurality of intermediate segments.

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

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

In some embodiments, the intermediate section comprises a plurality of first sections and a plurality of second sections, the edge section and the plurality of first sections being made of a non-degradable material, and the plurality of second sections being made of a degradable material.

In some embodiments, the edge section forms a plurality of first mesh openings in cooperation with the first section and the second section; the edge section and the first sections surround to form a plurality of second meshes, and the size of at least one second mesh is larger than that of one first mesh.

In some embodiments, each intersection of the middle section and the edge section forms a first connection point, each intersection of the first section and the corresponding second section forms a second connection point, and the covering membrane is seamlessly connected with the support framework at the positions of the first connection point and the second connection point.

In some embodiments, the covering membrane is seamlessly connected with the edge segment and all of the intermediate segments.

In some embodiments, the support framework and the covering film form a plugging disc, the plugging disc comprises a first plugging disc and a second plugging disc, the plugging device further comprises a pulling piece for connecting the first plugging disc and the second plugging disc, the first plugging disc and the second plugging disc are respectively used for plugging one side of the gap, and the pulling piece is used for adjusting the distance between the first plugging disc and the second plugging disc.

In some embodiments, the first occluding disk is located at the distal end of the second occluding disk, the first occluding disk is provided with a plurality of connecting rings through which the pulling member passes to effect connection of the pulling member with the first occluding disk; the connecting rings comprise a plurality of first connecting rings positioned outside the geometric center of the first plugging disc, a perforation is formed in the covering film of the first plugging disc, and the first connecting rings penetrate through the perforation and are fixed on the supporting framework of the first plugging disc.

In some embodiments, a filler body is disposed within the perforation such that the first connecting ring sealingly connects with the cover of the first occluding disk.

In some embodiments, the filler is filled in the through holes by electrospinning, dipping or spraying.

In some embodiments, the plurality of attachment rings includes a second attachment ring positioned at a geometric center of the first containment disc, the second attachment ring being secured to the support frame.

In a second aspect, embodiments of the present application provide a plugging system comprising a conveyor for conveying the plugging device to the breach, and a plugging device as described above.

The embodiment of the application provides a plugging device and plugging system, based on cover the tectorial membrane in at least one side of support skeleton, at least part and the support skeleton seamless connection in the tectorial membrane, the tissue can climb to its axis direction from plugging device's edge, thereby the area of the surface that plugging device needs endothelialization has been reduced, in addition, the joint strength between tectorial membrane and the support skeleton has still been improved, the proportion and the possibility that tectorial membrane and support skeleton break away from each other in the endothelialization process have been reduced, it is better to have avoided plugging device local endothelialization, the condition that local endothelialization speed is slower takes place, be difficult to form complication such as thrombus, inflammatory reaction and endothelial hyperplasia, be favorable to improving the speed of plugging device endothelialization.

Drawings

In order to more clearly illustrate the embodiments of the present application or the technical solutions in the prior art, the drawings needed to be used in the description of the embodiments or the prior art will be briefly introduced below, and it is obvious that the drawings in the following description are only some embodiments of the present application, and it is obvious for those skilled in the art that other drawings can be obtained according to the drawings without inventive exercise.

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

Fig. 2 is a schematic illustration of a first embodiment of an occlusion disk of an occlusion device of the occlusion system of fig. 1.

Figure 3 is a schematic illustration of a support skeleton of an occlusion device of the occlusion system of figure 2.

Fig. 4 is a schematic structural view of a second embodiment of the occluding disk of the occluding device of the occluding system of fig. 1.

Figure 5 is a schematic structural view of a first state of a support framework of an occlusion device of the occlusion system of figure 4.

Figure 6 is a structural schematic diagram of a second state of the support framework of the occluding device of the occluding system of figure 4.

Figure 7 is a schematic structural view of another embodiment of an occlusion device of the occlusion system of figure 1.

Fig. 8 is a schematic view of the inner side of the first occluding disk of the occluding device of the occluding system of fig. 7.

Description of the main elements

Occlusion system 1000

Occlusion device

100, 100a

Supporting

framework

101, 101a

Central convergence point 1011

First mesh 1012

Second meshes 1013

Edge segment 102

Intermediate section 104

First segment 1041

Second sections

1042, 1042a

Coating film 103

Perforation 1031

Plugging discs

105, 105a

Support ring 111

Intersection 113

First connecting point 1131

Second connection point 1132

End connection segment 114

First plugging disc 11

Second plugging disc 13

Connecting ring 12

First connection ring 121

Threading hole 1211

Second connection ring 122

Connecting piece 14

Traction member 15

Adjusting wire tie 150

Conveyor 200

Sheath 201

Control handle 202

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

Detailed Description

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, and it is obvious that the described embodiments are only a part of the embodiments of the present application, and not all of the embodiments. All other embodiments, which can be derived by a person skilled in the art from the embodiments given herein without making any creative effort, shall fall within the protection scope of the present application.

It is first noted that in the field of interventional medicine, along the delivery path of the instrument, the end of the instrument near the operator is often referred to as the proximal end, and the end of the instrument remote from the operator is referred to as the distal end. In particular, with respect to a delivery device for delivering and releasing an implantable device into a patient, distal end refers to the end of the delivery device that is freely insertable into the animal or human body, and proximal end refers to the end of the delivery device that is accessible to a user or machine.

It is understood that the terminology used in the description and claims of the present application and the accompanying drawings is for the purpose of describing particular embodiments only and is not intended to be limiting of the present application. The terms "first," "second," and the like in the description and claims of the present application and in the above-described drawings are used for distinguishing between different objects and not for describing a particular order. The singular forms "a", "an" and "the" are intended to include the plural forms as well, unless the context clearly indicates otherwise. The term "comprises" and any variations thereof is intended to cover non-exclusive inclusions. Further, the present application may be embodied in many different forms and is not limited to the embodiments described in the present embodiment. The following detailed description is provided for the purpose of providing a more thorough understanding of the present disclosure, and the words used to indicate orientation above, below, left and right are used solely to describe the illustrated structure in the context of the corresponding figures.

The description which follows is a preferred embodiment for carrying out the present application, however, the foregoing description is made for the purpose of illustrating the general principles of the present application and is not intended to limit the scope of the present application. The protection scope of the present application shall be subject to the definitions of the appended claims.

Referring to fig. 1, fig. 1 is a schematic structural diagram of an occlusion system 1000 according to an embodiment of the present disclosure. The plugging system 1000 includes a conveyor 200 and a plugging device 100. The occlusion device 100 is used to occlude a gap in tissue to be occluded. The conveyor 200 is used to transport and release the occluding device 100 to the breach. The defect in the tissue to be occluded is, for example, but not limited to, a tissue defect site in the vasculature. Including but not limited to the foramen ovale, ductus arteriosus, interatrial septum, ventricular 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 septum occlusion device, a ventricular septum occlusion device, or the like. It should be noted that, in the present application, the gap is taken as an example of the foramen ovale, and the advantage of the occlusion system 1000 for treating the patent foramen ovale is described. It will be appreciated that the notch may also be a site of other tissue defects as mentioned above.

Specifically, in the present embodiment, the transporter 200 includes a sheath 201 for housing the occluding device 100 and a control handle 202 fixed to a proximal end of the sheath 201. The control handle 202 is used for controlling the plugging device 100 to extend out of the sheath 201 and release to the gap; or for controlling the retrieval of the occluding device 100 into the sheath 201.

It should be understood by those skilled in the art that the illustration of fig. 1 is merely an example of the occlusion system 1000 and does not constitute a limitation of the occlusion system 1000, and that the occlusion system 1000 may include more or less components than those shown in fig. 1, or some components may be combined, or different components, e.g., the occlusion system 1000 may also include positioners, sensors, etc.

The occlusion device 100 is used to occlude a gap in tissue. The occlusion device 100 includes a supporting framework 101 and a covering membrane 103. The supporting framework 101 is used for releasing at the gap, the circumferential edge of the supporting framework 101 is used for covering the peripheral tissues of the gap, and the axial position of the supporting framework 101 is not used for contacting the peripheral tissues of the gap, and is used for plugging in the gap, namely, is used for plugging in a channel surrounded by the peripheral tissues of the gap. The embodiment of the application provides an occlusion device 100, based on covering the tectorial membrane 103 on at least one side of the supporting framework 101, at least part in the tectorial membrane 103 and the supporting framework 101 are in seamless connection, the tissue can climb from the edge of the occlusion device 100 to the axis direction thereof, thereby reducing the area of the surface of the occlusion device 100 which needs endothelialization, in addition, the connection strength between the tectorial membrane 103 and the supporting framework 101 is also improved, the proportion and the possibility of mutual separation between the tectorial membrane 103 and the supporting framework 101 in the endothelialization process are reduced, the local endothelialization of the occlusion device 100 is avoided to be better, the condition that the local endothelialization speed is slower occurs, complications such as thrombus, inflammatory reaction, endothelial hyperplasia and the like are not easy to form, and the rate of endothelialization of the occlusion device 100 is favorably improved.

In some embodiments, the coating 103 is directly formed on the supporting skeleton 101 by an electrospinning method, a dipping method or a spraying method, so that the coating 103 can be tightly formed on the outer surface of the supporting skeleton 101, i.e. the coating 103 covers the surface of the supporting skeleton 101, so as to achieve seamless connection between the coating 103 and the supporting skeleton 101. In other embodiments, the coating 103 is formed by electrospinning, dipping, spraying, casting, or weaving, and the formed coating is fixed to the supporting frame 101 by hot pressing or bonding, so that the coating 103 can be attached to the outer surface of the supporting frame 101 to reduce the occurrence of gaps at the connection between the supporting frame 101 and the coating 103.

Preferably, in this embodiment, the coating 103 is formed on the supporting skeleton 101 by electrostatic spinning to obtain the coating 103 with a large porosity, so that cells can better infiltrate into the coating 103, which is beneficial to the creeping and endothelialization of cells, and the tissue and the cells can be better combined.

In this embodiment, the plugging device 100 comprises two plugging discs, a first plugging disc 11 and a second plugging disc 13. The first plugging disc 11 and the second plugging disc 13 have similar structures, both of the two plugging discs include the supporting framework 101 and the covering film 103, the covering film 103 covers at least one side of the corresponding supporting framework 101, and at least part of the covering film 103 is in seamless connection with the corresponding supporting framework 101. In a modified embodiment, one of the two plugging discs comprises the supporting framework 101 and the coating 103, the coating 103 covers at least one side of the supporting framework 101, and at least part of the coating 103 is seamlessly connected with the supporting framework 101; the other of the two closure discs comprises only the supporting skeleton 101, i.e. the covering film 103 is omitted.

In the present embodiment, the first plugging disc 11 and the second plugging disc 13 are both in a single-layer disc surface shape, that is, in the axial direction, the supporting framework 101 forms a single-layer mesh surface structure. The first blocking disk 11 and the second blocking disk 13 are used for adhering to the peripheral tissue on both sides of the gap. In a modified embodiment, either one of the first plugging disc 11 and the second plugging disc 13 may be a double-layer mesh disc structure, that is, the supporting frame 101 may have a double-layer mesh surface structure in the axial direction.

The supporting skeleton 101 comprises an outer side facing away from the indentation and an inner side facing towards the indentation. In some embodiments, the covering film 103 is wrapped inside the supporting skeleton 101; alternatively, the coating 103 covers the outside of the supporting frame 101 to close the blood flow. In other embodiments, the covering film 103 covers the inner side and the outer side of the supporting framework 101, so that the covering film 103 and the supporting framework 101 are completely integrated, the whole disc surface and the tissue of the occlusion device 100 can be attached more conveniently, the cell endothelialization effect is better, and the endothelialization speed is faster.

Optionally, in this embodiment, the material of the covering film 103 includes a degradable material. The degradable material includes, but is not limited to, at least one of Polylactic acid (PLA), Polycaprolactone (PCL), polybutylene succinate (PBS), 1, 3-Propanediol (PDO), and Poly (L-lactide-co-e-caprolactone) series copolymers. Thus, the plugging device 100 of the present application is beneficial to improving the biocompatibility of the plugging device 100 by adopting the covering film 103 made of degradable material, the covering film 103 will be gradually degraded after being used for a certain time, and finally becomes water and carbon dioxide which are easily absorbed and metabolized by the human body, thereby being beneficial to reducing the stimulation to the human body, and further being capable of reducing the long-term complication rate of the long-term retention of the plugging device 100. Alternatively, in order to achieve both the strength of the coating 103 and the degradation degree of the coating 103, when the coating 103 is made of a degradable material, the thickness of the coating 103 is 0.001mm to 0.1mm, thereby ensuring that the coating 103 can be easily degraded in vivo while ensuring that the coating 103 has a certain strength.

In some embodiments, the material of the cover film 103 comprises a non-degradable material. The non-degradable material includes, but is not limited to, at least one of Polyethylene terephthalate (PET), Polytetrafluoroethylene (PTFE), Thermoplastic Polyurethane elastomer rubber (TPU), silicone rubber, hydrogel, Polyurethane (PU), Polyvinyl alcohol (PVA), Expanded polytetrafluoroethylene (Expanded PTFE), Polyethylene (PE), High Density Polyethylene (HDPE), Polyethylene 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 to 0.2 mm. In this way, when the mechanical properties of the film 103 are ensured to meet the standards, the thickness of the film 103 is as small as possible, and the thinner the thickness of the film 103 is, the lower the probability of some inflammation or chronic disease in the body caused by the film 103 is.

Referring to fig. 1 and 2 together, fig. 2 is a schematic diagram of a first embodiment of the occluding disk 105 of the occluding device 100 of the occluding system 1000 of fig. 1. As shown in fig. 2, the supporting skeleton 101 and the coating film 103 constitute a plugging disc 105.

The supporting frame 101 is constructed in a net structure. The supporting skeleton 101 may be woven of a woven wire having a shape memory effect to form a net structure; alternatively, the supporting skeleton 101 may be formed by cutting at least one of a rod-shaped structure, a tubular structure, and a plate-shaped structure having a shape memory effect to form a net-shaped structure. The mesh structure includes an edge segment 102 and a plurality of intermediate segments 104 connecting the edge segment 102. A plurality of intermediate segments 104 are located within the area enclosed by the edge segments 102. In this embodiment, the support scaffold 101 can be made of a degradable material and/or a degradable material.

The coating 103 is seamlessly connected to the edge segment 102 and optionally to the plurality of intermediate segments 104. In some embodiments, the covering membrane 103 is seamlessly connected with the edge section 102 and the entire middle section 104, which not only enhances the reliability and stability of the connection between the supporting framework 101 and the covering membrane 103, but also facilitates the improvement of the biocompatibility and the endothelialization rate of the occlusion device 100, is not easy to form complications such as thrombus, inflammatory reaction, endothelial hyperplasia, and the like, and has better occlusion effect.

In some embodiments, the covering film 103 may be seamlessly connected to at least a portion of the edge segment 102, such as where the covering film 103 is seamlessly connected to the edge segment 102 via some adhesive or heat-pressed points; alternatively, the coating 103 may also be directly joined seamlessly to the entirety of the edge section 102. In such embodiments, the coating 103 may not be fixedly attached to the intermediate section 104; alternatively, the coating 103 may be seamlessly connected to at least a portion of the intermediate section 104, for example, by bonding or hot pressing; alternatively, the cover film 103 may be connected to the intermediate section 104 by sewing or the like.

In some embodiments, the cover film 103 can be seamlessly connected to at least a portion of the intermediate section 104, such as by having the cover film 103 seamlessly connected to the intermediate section 104 via some adhesive or heat-staking points, or directly to all of the intermediate section 104. In such embodiments, the coating 103 may not be fixedly connected to the edge segment 102; alternatively, the covering film 103 may be seamlessly connected with at least a portion of the edge section 102, for example, by bonding or hot pressing; alternatively, the covering film 103 may be connected to the edge segment 102 by sewing or the like.

As shown in fig. 1, the radial dimension of the coating film 103 is larger than the radial dimension of the supporting skeleton 101, that is, the circumferential edge of the coating film 103 exceeds the edge section 102 of the supporting skeleton 101, and the circumferential edge of the coating film 103 is a free edge and is not fixed to the supporting skeleton 101. In some embodiments, such as shown in fig. 2, the circumferential edge of the cover film 103 is flush with the circumferential edge of the supporting skeleton 101, and the circumferential edge of the cover film 103 is fixed to the circumferential edge of the supporting skeleton 101. Referring to fig. 2 and 3 together, fig. 3 is a schematic structural diagram of the supporting framework 101 of the plugging disk 105 of fig. 2. As shown in fig. 3, the entire structure of the supporting skeleton 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 the present embodiment, the entire structure of the support frame 101 is made of a metal material. In some embodiments, the material of the support armature 101 comprises a non-degradable metallic material. The non-degradable metallic material includes, but is not limited to, at least one of stainless steel, tungsten alloy, cobalt-based alloy, and nickel titanium alloy. In other embodiments, the material of the support scaffold 101 comprises a degradable metallic material. The degradable metallic material includes, but is not limited to, at least one of magnesium alloy, iron alloy, or zinc alloy. In some embodiments, the material of the support scaffold 101 may also or further include at least one of a high molecular polymer material, a non-degradable, non-metallic material, a degradable, non-metallic material, or any combination therebetween.

The supporting frame 101 is constructed in a net structure. The supporting skeleton 101 may be woven of a woven wire having a shape memory effect to form a net structure; alternatively, the supporting skeleton 101 may be formed by cutting at least one of a rod-shaped structure, a tubular structure, and a plate-shaped structure having a shape memory effect to form a net-shaped structure. The mesh structure includes an edge segment 102 and a plurality of intermediate segments 104 connecting the edge segment 102. A plurality of intermediate segments 104 are located within the area enclosed by the edge segments 102. Wherein the edge segments 102 together enclose a closed area. Each intermediate section 104 is configured in an arcuate configuration. In some embodiments, the intermediate section may also exhibit a linear configuration.

Specifically, the support frame 101 has a convergence point 1011. The net structure is formed by a plurality of support rings 111 arranged in a staggered radial pattern. A plurality of support rings 111 are arranged circumferentially from a point of convergence 1011 of the mesh structure. In the present embodiment, the number of the support rings 111 is six, and the six support rings 111 are arranged in the circumferential direction in a clockwise direction or a counterclockwise direction and are cross-connected. In other embodiments, the number of the support rings 111 may also be 5, 8 or other numbers, and may be specifically set according to actual needs, for example, a plurality of support rings 111 are arranged in a circumferential direction in a clockwise direction or a counterclockwise direction and are disposed adjacent to or spaced apart from each other. Each support ring 111 may be, but is not limited to, oval, semi-circular, petal or irregular, etc. Each support ring 111 includes a circumferential segment 106 and two intermediate segments 104 connected to opposite ends of the circumferential segment 106. Each middle section 104 extends along the radial direction of the circumferential section 106 and is converged at a convergence point 1011, so that the reliability and stability of the connection between the support framework 101 and the covering film 103 are enhanced, and the plugging effect of the plugging device 100 is further improved. Each circumferential segment 106 extends in the circumferential direction of the web structure and all circumferential segments 106 are connected end to form an 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 relatively far away from the convergence point 1011 of the supporting frame 101 and connected with the edge section 102, and the second ends of the first section 1041 and the second section 1042 are relatively close to the convergence point 1011 of the supporting frame 101. In this embodiment, the material of the first section 1041 is the same as the material of the second section 1042, and both are made of metal material.

In some embodiments, the connections between any two adjacent support rings 111, i.e., the connections between the edge segments 102 and the middle segments 104 and between any two adjacent middle segments 104, may be fixedly connected together by welding, inserting, and/or winding and knotting. The middle section 104 and the circumferential section 106 of each support ring 111 may each include a plurality of metal braided wires, may be cut from a single metal tube, or may be a mixture of the two. Specifically, in some embodiments, when the middle section 104 is formed by directly cutting an entire metal tube, the edge section 102 includes a plurality of metal braided wires, and the middle section 104 is welded to the inner and/or outer peripheries 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, the plurality of metal braided wires form a gap therebetween. The middle section 104 of one of the support rings 111 is inserted into the gap of the middle section 104 of the other support ring 111 adjacent to the middle section 104; the circumferential segment 106 of one of the support rings 111 is inserted into the gap of the circumferential segment 106 of the other support ring 111 adjacent thereto, and optionally welded at the intersection of the two to improve the connection strength.

In some embodiments, the edge segment 102 includes a plurality of metal braid wires and is braided from the plurality of metal braid wires to form a unitary body, and the middle segment 104 includes a plurality of metal braid wires. In such an embodiment, the middle segment 104 is inserted into a slot in the edge segment 102; alternatively, the edge segment 102 is inserted into a slot in the middle segment 104. In other embodiments, the edge segment 102 comprises a plurality of metal wires and is formed by weaving the plurality of metal wires into a whole, the middle segment 104 is directly cut and formed from a metal tube, and the middle segment 104 is inserted into the slit of the edge segment 102. In other embodiments, the edge segment 102 is formed by directly cutting a metal tube, the middle segment 104 includes a plurality of metal braided wires, and the edge segment 102 is inserted into a slit of the middle segment 104.

Referring to fig. 4, fig. 4 is a schematic diagram of a second embodiment of the occluding disk 105a of the occluding device 100a of fig. 1. As shown in fig. 4, the supporting skeleton 101a and the cover film 103 constitute a plugging disk 105 a. The supporting frame 101a provided in this embodiment is mainly different from the supporting frame 101 provided in the first embodiment in that in this embodiment, the material of the edge section 102 is the same as that of the first section 1041, and the material of the first section 1041 may be different from that of the second section 1042 a; the coating 103 is also seamlessly connected to the edge segment 102 and the first segment 1041.

Every adjacent two support rings 111 are cross-connected, and the adjacent two support rings 111 cross each other to form one or more crossing points 113. The plurality of intersections 113 includes 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 of the middle segments 104, and a second connection point 1132 is formed at the intersection of each of the first segments 1041 and the corresponding second segment 1042 a. The first plurality of connection points 1131 are relatively far from a convergence point 1011 of the support frame 101 and the second plurality of 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 points 1131 and the convergence point 1011. Optionally, the cover 103 is seamlessly connected to the support frame 101 at locations corresponding to the first connection points 1131 and/or the second connection points 1132.

Referring to fig. 4 and 5, fig. 5 is a schematic structural view of a second embodiment of the occlusion device 100 of fig. 4 with the supporting framework 101a in the first state. As shown in fig. 5, a part of the structure of the supporting skeleton 101a is made of a first material, and the other 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 supporting skeleton 101a includes both the non-degradable material and the degradable material with biocompatibility, that is, part of the structure of the supporting skeleton 101a is made of the non-degradable material, and in this embodiment, the non-degradable material may be the above-mentioned non-degradable metal material. The other part of the structure of the supporting skeleton 101a is made of degradable material. Degradable materials are added into the supporting framework 101a of the plugging device 100 in the application, so that the release of metal ions is reduced, the degradable framework is not left in the body after being degraded, and the incidence rate of complications is reduced. The degradable material comprises a degradable metal material and/or the degradable non-metal material. Degradable non-metallic materials include, but are not limited to, polylactic acid, polycaprolactone, polybutylene succinate, copolymers of 1, 3-propanediol and poly (L-lactide-co-e-caprolactone), polygluconate (polyglyconate), polyhydroxybutyrate (polyhydroxybutyrate), polyanhydride (polyanhydride), polyphosphate (polyphoester), or copolymers or blends of at least two thereof.

As shown in fig. 5, the material of the first section 1041 is different from the material of the second section 1042 a. In this embodiment, the first section 1041 is made of a non-degradable material and the second section 1042a is made of a 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-metal material, so as to ensure the overall supporting strength and mechanical properties such as resilience of the supporting framework 101a, reduce the metal content of the supporting framework 101a, and reduce 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, so as to reduce the risk of inflammatory reaction caused by the supporting framework 101a, which is beneficial to reducing the stimulation of the supporting framework 101a on the tissue to be blocked. Specifically, the first sections 1041 are uniformly spaced, so that the overall strength of the supporting framework 101a can be ensured after the second section 1042a is partially or completely degraded, and the phenomenon that the supporting framework 101a is deformed to reduce the plugging effect is avoided. Optionally, the geometric centers of the first segments 1041 of the self-supporting framework 101a are arranged in a central symmetry manner, so that the stress uniformity of the supporting framework 101a is improved, and the tissue to be blocked is better blocked. The plurality of first segments 1041 are integrally connected to the edge segment 102, thereby increasing the overall strength of the supporting frame 101 a. In some embodiments, the number of the second sections 1042a may be greater than the number of the second sections 1042a, thereby improving the mechanical properties such as the overall strength and resilience of the supporting skeleton 101 a. In other embodiments, for example, the number of the first sections 1041 may 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 alternately arranged to take into consideration the strength and the biocompatibility of the supporting framework 101 a.

Referring to fig. 5 and 6 together, fig. 6 is a schematic structural view illustrating the supporting framework 101a of the occlusion device 100 in fig. 4 in a second state according to the second embodiment, wherein the first state is a state before the plurality of second sections 1042 of the supporting framework 101 are degraded; the second state refers to a state after the plurality of second sections 1042 of the support skeleton 101 are degraded. It is understood that before the degradation of the plurality of second sections 1042, the rim section 102 forms a plurality of first meshes 1012 with the first section 1041 and the second section 1042; after the degradation of the second plurality of segments 1042, the rim segment 102 and the first plurality of segments 1041 form a second plurality of mesh openings 1013, at least one of the second mesh openings 1013 has a size larger than a size of one of the first mesh openings 1012, thereby facilitating subsequent endothelialization of the occluding device 100 and puncturing of tissue to be treated (e.g., atrial septum) at the location of the second mesh openings 1013. Optionally, in the case that the materials of the second section 1042a and the coating film 103 are degradable materials, the puncturing operation is more convenient. The plurality of first mesh openings 1012 may be the same or different in shape and size. In this embodiment, the plurality of first mesh openings 1012 have the same shape and are different from each other. Specifically, in the circumferential direction of the supporting skeleton 101, the shape and size of any adjacent two first mesh holes 1012 are the same. Any adjacent two first mesh holes 1012 are different in shape and size in the radial direction of the supporting frame 101. The plurality of second meshes 1013 are identical in shape and size, and each of the second meshes 1013 has an area larger than that of any one of the first meshes 1012.

Referring to fig. 7, fig. 7 is a schematic structural diagram of another embodiment of the occluding device 100a of the occluding system 1000 of fig. 1. In this embodiment, the structure of the occluding device 100a is similar to that of the occluding device 100a of the first embodiment. The difference is that the circumferential edge of the coating 103 is flush with the circumferential edge of the support frame 101, and the circumferential edge of the coating 103 is fixed to the circumferential edge of the support frame 101.

Referring to fig. 1 and fig. 7 to 8 together, fig. 8 is a schematic view of the inner side of the first occluding disk 11 in the occluding device 100a of the occluding system 1000 in fig. 7. In the present embodiment, each adjacent two support rings 111 are cross-connected, and the adjacent two support rings 111 cross each other to form one or more cross points 113. The plurality of intersections of the support ring 111 only include the plurality of first connecting points 1131, that is, the first connecting point 1131 is formed at the intersection of each middle section 104 and the edge section 102, and the end connecting section 114 is formed at one end of any two adjacent middle sections 104 far away from the edge section 102, so as to ensure the mechanical properties of the support framework 101, such as overall support strength and resilience. Optionally, the cover film 103 is seamlessly connected to the supporting skeleton 101 at locations corresponding to the first connection points 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 an end distal from the edge segment 102, and any two adjacent connecting segments are spaced apart.

In this embodiment, the occluding device 100a comprises a first occluding disk 11 and a second occluding disk 13. The occluding device 100a further comprises a pull member 15 connecting the first occluding disk 11 and the second occluding disk 13. The first and second plugging

discs

11, 13 are both used for plugging the gap, i.e. the first and second plugging

discs

11, 13 are used for covering one side of the gap in the plugged tissue, respectively. The pull piece 15 serves to adjust the distance between the first closing disk 11 and the second closing disk 13.

Specifically, the first blocking disc 11 is located at a distal end of the second blocking disc 13, a plurality of connection rings 12 are disposed on the first blocking disc 11, the pulling element 15 penetrates through the connection rings 12, the connection rings 12 include a plurality of first connection rings 121 located outside a geometric center of the first blocking disc 11, a through hole 1031 is disposed on a covering film 103 of the first blocking disc 11, and the first connection rings 121 penetrate through the through hole 1031 and are fixed on the supporting framework 101 of the first blocking disc 11, and preferably, penetrate through a gap formed between a plurality of metal braided wires on the supporting framework 101 (refer to the above embodiment, which is not described herein again). The pulling elements 15 pass through a plurality of connecting rings 12 to achieve the connection of the pulling elements 15 with the first plugging disc 11.

The first link ring 121 is formed in a ring shape and has a threading hole 1211, and the pulling member 15 passes through the threading hole 1211 of the first link ring 121. When the pulling element 15 is pulled tight, the pulling element 15 can slide in the first connecting ring 121, thereby assisting in adjusting the length of the pulling element 15 between the first closing disk 11 and the second closing disk 13 and thus the distance between the first closing disk 11 and the second closing disk 13. The first coupling rings 121 may be fixed to the first plugging disc 11 by means of bonding, knotting, or the like.

Optionally, a filling body is disposed in the through hole 1031, so that the first connection ring 121 is in sealing connection with the covering film 103 of the first blocking disk 11, thereby further reducing the area of the surface of the blocking device 100a that needs endothelialization, and the tissue crawls from the edge of the blocking device 100a to the axial direction, which is beneficial to improving the biocompatibility and the endothelialization rate of the blocking device 100a, and is not easy to form complications such as thrombus, inflammatory reaction, and endothelial hyperplasia. The filling material may be, but is not limited to, filled in the through holes 1031 by electrospinning, dipping, or spraying. It is understood that the material of the film 103 is suitable for the material of the filler, and the material of the filler may be other materials having biological identity.

The both ends of tractive spare 15 pass second shutoff dish 13 and at one side formation regulation knot 150 that second shutoff dish 13 deviates from first shutoff dish 11, the interval between first shutoff dish 11 and the second shutoff dish 13 can be adjusted through the tip of adjusting tractive spare 15 to adapt to different patients and different tissue anatomy's demand. The disc surfaces of the first blocking disc 11 and the second blocking disc 13 may be in the shape of a circle, a polygon, an ellipse, a triangle or other irregular shapes, and the radial size of the first blocking disc 11 may be the same as or different from the radial size of the second blocking disc 13, for example, the radial size of the first blocking disc 11 is smaller than the radial size of the second blocking disc 13. In this embodiment, the first plugging disc 11 and the second plugging disc 13 are both substantially hexagonal discs, and the radial dimension of the first plugging disc 11 is equal to the radial dimension of the second plugging disc 13. The construction of the second plugging disc 13 is similar to that of the first plugging disc 11, with the difference that no plurality of connecting rings are provided on the second plugging disc 13. The structure of the first closing disk 11 will be described in detail below.

In the present embodiment, in the second plugging disc 13 and the first plugging disc 11, each support ring 111 is formed by winding and weaving a plurality of braided wires or by arranging the plurality of braided wires side by side, that is, all the support rings 111 are formed into a disc structure by winding and weaving a plurality of braided wires, so that the first plugging disc 11 and the second plugging disc 13 have strong flexibility and mechanical strength, and can be sufficiently attached to the surface of the tissue to be plugged. The supporting framework 101 of the first plugging disc 11 and the supporting framework 101 of the second plugging disc 13 are respectively any one of 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. In this embodiment, the supporting framework 101 of the first plugging disc 11 and the supporting framework 101 of the second plugging disc 13 are both single-layer woven mesh structures.

It will be appreciated that in some embodiments, some of the support rings 111 in the first containment disc 11 are comprised of a plurality of braided filaments and other support rings 111 in the first containment disc 11 are comprised of a plurality of braided filaments. In some embodiments, the supporting skeleton 101 may also be formed into a disc-like structure with an open-work structure by laser cutting the plate/tubular nitinol, thereby enhancing the support of the supporting skeleton 101.

In the first plugging disc 11, the plurality of connection rings 12 further comprises a second connection ring 122, and the plugging device 100a further comprises a connection member 14, wherein the second connection ring 122 is connected to the supporting framework 101 through the connection member 14. The connecting piece 14 is arranged in the geometric center of the first closing disk 11. In other embodiments, the connecting element 14 is arranged eccentrically on the first closing disk 11. Specifically, a plurality of support rings 111 supporting the bobbin 101 are provided around the circumference of the connector 14. Preferably, the support rings 111 on the first plugging disc 11 are evenly spaced. The secondary connecting ring 122 is wound around the connecting member 14 such that the secondary connecting ring 122 is located approximately at the geometric center of the primary containment disc 11. Optionally, a plurality of support rings 111 are circumferentially arranged at least one revolution around the connector 14 to form a single or multi-layered mesh structure.

The connecting piece 14 and the supporting framework 101 can be integrally formed; or may be fixedly attached together by welding, adhesive, or the like. The connecting member 14 may be a steel sleeve with two open ends, and the connecting member 14 may also be a combination of multiple steel sleeves. The ends of the support rings 111 are connected to the outer circumferential surface of the connector 14, and are fixedly connected to the outer circumferential surface of the connector 14 by welding or bonding. The material of the connector 14 includes, but is not limited to, stainless steel, nitinol, or other biocompatible material.

The secondary connecting ring 122 may be fixed to the connecting member 14 by means of adhesion, knotting, or the like, so as to prevent the secondary connecting ring 122 from being displaced. The primary connecting ring 121 is disposed around the circumference of the secondary connecting ring 122. The number of the first and second connection rings 121 and 122 may each include one or more. In the present 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 uniformly arranged at least one turn around the second connecting ring 122 to improve the uniformity of the force applied to the first blocking disk 11 during the wire retrieving and releasing process of the pulling member 15. In some embodiments, the plurality of first connecting rings 121 are evenly spaced. The second connection ring 122 is annular and forms a threading hole, and the pulling member 15 is inserted into the threading hole of the first connection ring 121 and the threading hole of the second connection ring 122.

Preferably, the second connecting ring 122 is disposed at the geometric center of the first plugging disc 11, the pulling member 15 passes through the threading hole of the second connecting ring 122 and is tensioned, the intersection of the second connecting ring 122 and the pulling member 15 is located at the geometric center of the first plugging disc 11, so that the first plugging disc 11 is subjected to uniform tension, and when the length of the pulling member 15 is adjusted after the first plugging disc 11 is positioned, the first plugging disc 11 is not easily deflected.

The attachment ring 12 and the puller 15 may be selected from non-absorbable biocompatible sutures, such as metal wire, cotton, polyester, polypropylene, and the like. The attachment loop 12 and the pulling member 15 may be absorbable biocompatible sutures, such as catgut, polyglycolide, multifilament non-biodegradable sutures, etc., and the pulling member 15 may be forcibly wound with a fiber thread, etc.

In the present embodiment, the material of the connection 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, polylactic acid, collagen, nylon suture, and polyester suture. Preferably, the pull 15 is a suture made of polytetrafluoroethylene. The mechanical strength of the teflon material is high, so that the toughness of the pulling piece 15 is improved. Preferably, the material of the connection ring 12 is selected from polypropylene having good tensile strength and hardness. The attachment ring 12 is a double-stranded suture that provides the occluding device 100a with greater attachment strength. In other embodiments, the attachment ring 12 may employ more than one strand of suture, or one strand of suture.

Referring to fig. 1-8 together, in use, first occluding disk 11 is delivered from and deployed in the left atrium by delivery device 200, and second occluding disk 13 is delivered to and deployed in the right atrium by delivery device 200. The traction piece 15 connected between the first plugging disc 11 and the second plugging disc 13 is flexible and adjustable in length, and the traction piece 15 penetrates through an oval hole between the primary diaphragm and the secondary diaphragm; the free end of the pulling piece 15 is pulled towards the near end, the pulling piece 15 is tensioned, the pulling piece 15 is located in the geometric center of the first blocking disc 11, the pulling piece 15 is gradually shortened, namely the distance between the first blocking disc 11 and the second blocking disc 13 is gradually reduced, the primary diaphragm and the secondary diaphragm are close to each other and clamped by the first blocking disc 11 and the second blocking disc 13, the primary diaphragm and the secondary diaphragm are covered by the first blocking disc 11 around the foramen ovale, and the primary diaphragm and the secondary diaphragm are covered by the second blocking disc 13 around the foramen ovale, namely openings on two sides of the foramen ovale in the left atrium and the right atrium are respectively covered by the first blocking disc 11 and the second blocking disc 13. Because first shutoff dish 11 and second shutoff dish 13 all include supporting framework 101 and seamless connection at least supporting framework 101 on tectorial membrane 103, the tectorial membrane 103 of foramen ovale both sides can prevent blood to flow into the foramen ovale to avoided the blood flow to flow into the right atrium from the left atrium, in order to realize instant shutoff. After the plugging

devices

100, 100 are implanted, the primary diaphragm and the secondary diaphragm crawl to the contact position of the first plugging disc 11 and the second plugging disc 13 to close the foramen ovale after the endothelialization is completed, and a complete atrial septum is formed.

The plugging device in the embodiment of the application is of a double-plugging-disc structure, and the two plugging discs are separated. In a modified embodiment, the occlusion device may also be in the shape of a column, i.e. the supporting skeleton is in the shape of a plunger, the supporting skeleton enclosing an inner cavity. The plugging device can also be in an integrated double-plugging-disc structure, an integrally-formed waist part is further arranged between the double plugging discs, or the plugging device is in other regular or irregular shapes, and the specific structure of the plugging device is not limited.

It is understood that the covering film may be disposed at a predetermined position on the support frame as desired. The preset position can be an outer side surface of the supporting framework, which is used for contacting with peripheral tissues of the gap, or an inner cavity surrounded by the supporting framework.

It will be appreciated that in some embodiments, the porosity of the covering membrane may be increased to facilitate infiltration of tissue cells into the covering membrane, facilitating endothelialization of the supporting scaffold and covering membrane.

The embodiment of the application provides a plugging device and a plugging system, based on will in the tectorial membrane at least part with support skeleton seamless connection to reduced the area of the surface that the plugging device needs endothelialization, treat that the shutoff tissue crawls from the edge of plugging device to the axis direction and attach, be favorable to improving the speed of plugging device endothelialization.

The foregoing detailed description of the embodiments of the present application has been presented to illustrate the principles and implementations of the present application, and the above description of the embodiments is only provided to help understand the method and the core concept of the present application; meanwhile, for a person skilled in the art, according to the idea of the present application, there may be variations in the specific embodiments and the application scope, and in view of the above, the content of the present specification should not be construed as a limitation to the present application.

Claims

1. An occlusion device for occluding a notch in tissue, the occlusion device comprising:

2. The occlusion device of claim 1, wherein the covering membrane is formed directly on the support scaffold by electrospinning, dipping, or spraying; alternatively, the first and second electrodes may be,

3. The occlusion device of claim 1, wherein the support frame includes an outer side facing away from the notch and an inner side facing toward the notch, the covering membrane covering the inner side of the support frame; or, the outer side of the supporting framework is coated; or the inner side and the outer side of the supporting framework are coated.

4. The occlusion device of claim 1, wherein the material of the covering membrane comprises a non-degradable material comprising at least one of polyethylene terephthalate, polytetrafluoroethylene, thermoplastic polyurethane elastomer rubber, silicone rubber, hydrogel, polyurethane, polyvinyl alcohol, expanded polytetrafluoroethylene, polyethylene, high density polyethylene, polyethylene terephthalate.

5. The occlusion device of claim 4, wherein the covering membrane has a thickness of 0.01-0.2 mm.

6. The occlusion device of claim 1, wherein the material of the covering membrane comprises a degradable material comprising at least one of polylactic acid, polycaprolactone, polybutylene succinate, 1, 3-propanediol, and poly (L-lactide-co-e-caprolactone) series copolymers.

7. The occlusion device of claim 6, wherein the covering membrane has a thickness of 0.001mm to 0.1 mm.

8. The occlusion device of claim 1, wherein the material of the support scaffold comprises at least one of a degradable material and a non-degradable material.

9. The occlusion device of claim 8, wherein a portion of the structure of the support scaffold is made of the degradable material and a remaining portion of the structure of the support scaffold is made of a non-degradable material.

10. The occlusion device of claim 8, wherein the support scaffold is configured as a mesh structure comprising an edge segment and a plurality of intermediate segments connecting the edge segment, the plurality of intermediate segments being located within an area bounded by the edge segment, the covering membrane being seamlessly connected with the edge segment and optionally the plurality of 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, the edge segments and the plurality of first segments being made of a non-degradable material, and the plurality of second segments being made of a degradable material.

12. The occlusion device of claim 11, wherein the edge segment surrounds the first segment and the second segment to form a plurality of first mesh openings; the edge section and the first sections surround to form a plurality of second meshes, and the size of at least one second mesh is larger than that of one first mesh.

13. The occlusion device of claim 10, wherein each intersection of the intermediate segment and the edge segment forms a first connection point, each intersection of the first segment and the corresponding second segment forms a second connection point, and wherein the covering membrane is seamlessly connected to the support scaffold at the location of the first connection point and the second connection point.

14. The occlusion device of claim 10, wherein the covering membrane is seamlessly connected to the edge segment and all of the intermediate segments.

15. The occlusion device of any of claims 1-14, wherein the support framework and the covering membrane form an occlusion disc, the occlusion disc comprising a first occlusion disc and a second occlusion disc, the occlusion device further comprising a pull member connecting the first occlusion disc and the second occlusion disc, the first occlusion disc and the second occlusion disc each for occluding a side of the gap, the pull member for adjusting a distance between the first occlusion disc and the second occlusion disc.

16. The occlusion device of claim 15, wherein the first occlusion disc is located at a distal end of the second occlusion disc, the first occlusion disc having a plurality of attachment rings disposed thereon, the pull member passing through the plurality of attachment rings to effect connection of the pull member to the first occlusion disc; the connecting rings comprise a plurality of first connecting rings positioned outside the geometric center of the first plugging disc, a perforation is formed in the covering film of the first plugging disc, and the first connecting rings penetrate through the perforation and are fixed on the supporting framework of the first plugging disc.

17. The occlusion device of claim 16, wherein a filler body is disposed within the perforation to sealingly couple the first connector ring to the cover of the first occluding disk.

18. The occlusion device of claim 17, wherein the filler is filled into the perforations by electrospinning, dipping, or spraying.

19. The occlusion device of claim 16, wherein the plurality of attachment loops comprises a secondary attachment loop, the occlusion device further comprising a connector by which the secondary attachment loop is secured to the support framework.

20. A plugging system comprising a conveyor for conveying the plugging device to the breach and the plugging device of any one of claims 1-19.