CN212996550U - Plugging device and plugging system - Google Patents

Abstract

The utility model provides an occluder for defect in the shutoff vasculature, the occluder includes first shutoff dish, second shutoff dish and tightens up the line, and first shutoff dish and second shutoff dish are used for covering defective different openings respectively, be equipped with the connecting piece on the first shutoff dish, the connecting piece is provided with the through wires hole, the tightens up the line and passes the through wires hole of connecting piece, the both ends of tightening up the line are passed the second shutoff dish, and second shutoff dish deviates from one side of first shutoff dish forms the regulation knot of thread, first shutoff dish with interval between the second shutoff dish can pass through the tip of tightening up the line is adjusted. The utility model also provides a plugging system who sets up the plugging device.

Description

Plugging device and plugging system

Technical Field

The utility model relates to the field of medical equipment, especially, relate to a be used for the defective plugging device in the shutoff human body, and be equipped with the plugging system of plugging device, but the plugging device shutoff oval hole also can be used to shutoff ductus arteriosus and defect such as interatrial septum and ventricular septum.

Background

The Patent Foramen ovale is generally closed in the first 1 year after the birth of a fetus, and Patent Oval Foramen ovale (PFO) is not closed in children older than 3 years old, and 20% -25% of adult Patent Foramen ovales are incompletely closed. Patent foramen ovale refers to a deformity of horizontal shunting of atria caused by incomplete fusion of primary diaphragm and secondary diaphragm in fossa ovalis and a permanent fissure-like defect in the middle. Patent foramen ovale is associated with a variety of clinical conditions, including paradoxical systemic embolism, such as ischemic stroke, transient ischemic attack, myocardial infarction, peripheral vascular embolism, decompression sickness, hypoxemia, and migraine headaches.

In recent years, due to the technical progress of cardiac catheters and the improvement of materials of occluders, interventional occlusion has gradually replaced open chest surgery to become the clinical first choice for patent-adapted patent foramen ovale. The patent foramen ovale occluder among the prior art generally comprises two quotations and the thin waist of cylinder of connecting between two quotations, the thin waist of cylinder will be primary apart from secondary apart extrusion deformation, and two quotations are fixed in order to block the blood circulation to the defect clamp after the deformation.

However, the cylinder slender waist length of the patent foramen ovale occluder in the prior art cannot be adjusted, and is only suitable for treating patent foramen ovale with overlapping length of primary septum and secondary septum within a certain range, and the patent foramen ovale with longer or shorter overlapping length is difficult to achieve the occluder effect, after treatment, a large residual shunt is easily generated between the primary diaphragm and the secondary diaphragm, and blood flow velocity changes when flowing through the patent foramen ovale, so that thrombosis can be induced. Therefore, the patient needs to prolong the time of anticoagulation treatment, and if the formed thrombus enters blood circulation, serious adverse events such as embolism and the like can be caused; moreover, the distance between the double-disc plugging surfaces of the traditional plugging device is fixed, and the distance of the waist can not be adjusted according to the structure of the foramen ovale so as to conform to the anatomical structure of the foramen ovale.

SUMMERY OF THE UTILITY MODEL

The utility model provides an occluder for defect in the shutoff vasculature, the occluder includes:

the first plugging disc and the second plugging disc are respectively used for covering different openings of the defect, a connecting piece is arranged on the first plugging disc, and a threading hole is formed in the connecting piece; and the tightening line penetrates through the threading hole of the connecting piece, two ends of the tightening line penetrate through the second plugging disc, an adjusting knot is formed on one side, deviating from the first plugging disc, of the second plugging disc, and the distance between the first plugging disc and the second plugging disc can be adjusted through the end part of the tightening line.

The utility model also provides a plugging system, including occluder and conveyer, the occluder includes first shutoff dish, second shutoff dish and tightens up the line, and first shutoff dish and second shutoff dish are used for covering defective different openings respectively, be equipped with the connecting piece on the first shutoff dish, the connecting piece is provided with the through wires hole, the tightening up the line passes the through wires hole of connecting piece, the both ends of tightening up the line pass the second shutoff dish, and form the regulation knot in the second shutoff dish deviates from one side of first shutoff dish, the interval between first shutoff dish and the second shutoff dish can pass through the tip of tightening up the line is adjusted; the conveyor is used for connecting the tightening line and controlling the end part of the tightening line so as to adjust the distance between the first blocking disc and the second blocking disc.

In the plugging system provided by the utility model, two plugging disks are respectively covered around different openings of the defect, two ends of the tightening wire pass through the second plugging disk, and an adjusting knot is formed on one side of the second plugging disc, which is far away from the first plugging disc, the distance between the first plugging disc and the second plugging disc can be adjusted through the end part of the tightening line, so that defects of different types can be plugged, the joint degree of the two plugging discs and peripheral tissues of the defect part can be improved, and the defect can be plugged stably, after the plugging device is implanted, the deformation degree of the defect part is ensured to be smaller, endothelialization of the plugging disc is not influenced, the generation of residual shunt is reduced, the trouble that the plugging device needs to be customized due to the specific defect structure of an individual patient is avoided, the application range of the plugging device is effectively expanded, and more patients can benefit from minimally invasive surgery.

In addition, the tightening wire penetrates through the threading hole of the connecting piece to be connected with the first plugging disc, so that in the process of adjusting the tightening wire, the tightening wire can freely slide in the threading hole, the length of the tightening wire between the two plugging discs is changed, and the distance between the two plugging discs is changed. For the connected mode of the connecting piece lug connection on first shutoff dish of tightening wire not through having the through wires hole, guaranteed in this application that the hookup location of tightening wire and first shutoff dish is difficult to change to the in-process tightening wire of adjusting distance between two shutoff dishes slides more smoothly in the through wires hole. In addition, if the first plugging disc is covered with membrane bodies such as a flow-resisting membrane, the tightening wire penetrates through the threading hole of the connecting piece to be connected with the first plugging disc, so that the number of pores formed by the tightening wire on the membrane body of the first plugging disc is reduced, the integrity of the membrane body is maintained, and the probability of residual shunt and membrane body damage generated after the plugging device is implanted into a human body is reduced.

Drawings

In order to more clearly illustrate the technical solutions of the embodiments of the present invention, the drawings needed to be used in the embodiments will be briefly described below, and it is obvious that the drawings in the following description are some embodiments of the present invention, and for those skilled in the art, other drawings can be obtained according to these drawings without creative efforts.

Fig. 1 is a schematic perspective view of a plugging system according to an embodiment of the present invention.

Fig. 2 is a schematic view of the first occluding disk of the occluding system of fig. 1.

Fig. 3 is an enlarged view of the portion III in fig. 2.

Fig. 4 is an enlarged view of the portion IV in fig. 1.

Fig. 5 is a schematic structural view of a portion of the first supporting framework and one of the second coils in fig. 2.

Fig. 6 is a schematic view of the knotting pattern of each second loop in fig. 2.

Fig. 7 is an enlarged schematic view of the adjusting knot of fig. 1.

Fig. 8 is a schematic structural view of another embodiment of the first containment disc of fig. 2.

Fig. 9 is a schematic structural view of a further embodiment of the first containment disc of fig. 2.

Fig. 10 is a schematic structural view of a further embodiment of the first plugging disc in fig. 2.

Fig. 11 is a schematic structural view of another embodiment of the first supporting framework and one of the second coils in fig. 5.

Fig. 12 is a schematic structural view of another embodiment of the first supporting framework and one of the second coils in fig. 5.

Fig. 13 is a schematic view of one of the structures of the supporting framework of the occluder according to one embodiment of the present invention.

Fig. 14 is a schematic view of another structure of the supporting framework of the occluder according to an embodiment of the present invention.

Fig. 15 is a schematic structural view of the support skeleton in fig. 14 provided with a flow-blocking film.

Fig. 16 is a schematic view of another structure of the supporting framework of the occluder according to an embodiment of the present invention.

Fig. 17 is a schematic view of another structure of the supporting framework of the occluder according to an embodiment of the present invention.

Fig. 18 is a schematic view of another structure of the supporting framework of the occluder according to an embodiment of the present invention.

Detailed Description

The technical solutions in the embodiments of the present invention will be described clearly and completely with reference to the accompanying drawings in the embodiments of the present invention, and it is obvious that the described embodiments are only some embodiments of the present invention, not all embodiments. Based on the embodiments in the present invention, all other embodiments obtained by a person skilled in the art without any creative effort belong to the protection scope of the present invention.

Furthermore, the following description of the various embodiments refers to the accompanying drawings, which are included to illustrate specific embodiments in which the invention may be practiced. The utility model discloses in, the one end far away relatively apart from the operator is the distal end, and the one end near relatively apart from the operator is the near-end. Directional phrases used in this disclosure, such as "upper," "lower," "front," "rear," "left," "right," "inner," "outer," "side," and the like, refer only to the orientation of the attached drawing figures and, thus, are used in a better and clearer sense to describe and understand the present invention rather than to indicate or imply that the device or element so referred to must have a particular orientation, be constructed and operated in a particular orientation, and thus should not be considered limiting of the invention.

Referring to fig. 1-3, the present invention provides an occlusion system 100, which includes an occluder 20 and a conveyor 50 for releasing the occluder 20, wherein the occluder 20 is used to occlude defects in the vasculature, including but not limited to foramen ovale, ductus arteriosus, atrial septal defects, ventricular septal defects, etc., and the advantages of the occlusion system 100 for treating patent foramen ovale are illustrated herein by way of example of the defect being a foramen ovale, it being understood that the defect may also be other defects as mentioned above.

The occluder 20 comprises a first occluding disk 21, a second occluding disk 23 and a tightening piece, wherein the first occluding disk 21 and the second occluding disk 23 are respectively used for covering different openings of defects in a vascular system, a connecting piece 27 is arranged on the first occluding disk 21, and a threading hole 270 is arranged on the connecting piece 27; the tightening piece is a tightening wire 25, the tightening wire 25 passes through the threading hole 270 of the connecting piece 27, the two ends of the tightening wire 25 pass through the second plugging disc 23 and form an adjusting knot 250 on one side of the second plugging disc 23 departing from the first plugging disc 21, and the distance between the first plugging disc 21 and the second plugging disc 23 can be adjusted through the end part of the tightening wire 25. The conveyor 50 comprises a sheath 52 and a handle 54, the sheath 52 is used for accommodating the occluder 20 and conveying the occluder 20 into the vascular system of the human body; a handle 54 is connected to the proximal end of the sheath 52 for controlling the delivery of the occluding device 20, the release of the occluding device 20 and adjusting the distance between the first occluding disk 21 and the second occluding disk 23 by adjusting the tightening wire 25 to meet the requirements of different patients and different tissue anatomies.

The utility model discloses a back is implanted to plugging system 100, and first shutoff dish 21 and second shutoff dish 23 cover respectively in organizing both sides, and one side that first shutoff dish 21 and second shutoff dish 23 are used for the centre gripping tissue is the inboard of first shutoff dish 21 and second shutoff dish 23, and first shutoff dish 21 and second shutoff dish 23 deviate from by one side of centre gripping tissue for the outside. In this embodiment, the occluder is a foramen ovale occluder, and the periphery of openings at two opposite sides of the foramen ovale, namely, the areas adjacent to the foramen ovale on the two side surfaces of the primary diaphragm and the secondary diaphragm, are covered by the first occluding disk 21 and the second occluding disk 23. First shutoff dish 21 and second shutoff dish 23 are used for covering one side of primary diaphragm and secondary diaphragm and are the inboard of two shutoff dishes, and one side that first shutoff dish 21 and second shutoff dish 23 deviate from primary diaphragm and secondary diaphragm is the outside of two shutoff dishes. The tightening wire 25 passes through the threading hole 270 of the connecting member 27, and both ends of the tightening wire 25 pass through the second plugging disc 23, and an adjusting knot 250 is formed outside the second plugging disc 23; through adjusting the tightening wire 25 of connecting in first shutoff dish 21 and second shutoff dish 23 to control the interval between first shutoff dish 21 and the second shutoff dish 23, realize the defect of shutoff different grade type, thereby be favorable to improving first shutoff dish 21 and second shutoff dish 23 with thereby the oval hole is stably sealed up to the laminating degree of the tissue around the oval hole. After the occluder 20 is implanted, the deformation degree of the primary diaphragm and the secondary diaphragm is ensured to be small, endothelialization of the primary diaphragm and the secondary diaphragm to an occlusion disc is not influenced, the generation of residual shunt is reduced, the trouble that the occluder needs to be customized due to the specific oval hole structure of an individual patient is avoided, the application range of the PFO occluder is effectively expanded, and more patients benefit from minimally invasive surgery; in addition, the tightening wire 25 passes through the threading hole 270 of the connecting member 27 to connect the first blocking plates 21, so that the tightening wire 25 can freely slide in the threading hole 270 in the process of adjusting the tightening wire 25, and the length of the tightening wire 25 between the two blocking plates is changed, thereby changing the distance between the two blocking plates. For the connection mode of tightening wire 25 not through the connecting piece 27 lug connection on first shutoff dish 21 that has threading hole 270, guaranteed in this application that the hookup location of tightening wire 25 and first shutoff dish 21 is difficult to change to the in-process tightening wire 25 of adjusting distance between two shutoff dishes slides in threading hole 270 more smoothly. In addition, if the first blocking disc 21 is covered with membrane bodies such as a flow-blocking membrane, the tightening thread 25 passes through the threading hole of the connecting piece 27 to connect the first blocking disc 21, which is beneficial to reducing the pore space formed by connecting the tightening thread on the membrane body of the first blocking disc 21, keeping the integrity of the membrane body and reducing the probability of residual shunt and membrane body damage after the occluder is implanted into a human body.

As shown in fig. 2 and 3, the first blocking plate 21 includes a central region 211 and an edge region 213 located at an edge of the central region 211, the connecting member 27 includes a first coil 271 disposed at a middle portion of the central region 211, the first coil 271 is annular and forms a threading hole 270, and the tightening wire 25 passes through the threading hole 270 of the first coil 271. When the tightening wire 25 is tightened, the tightening wire 25 can slide in the first coil 271, thereby assisting in adjusting the length of the tightening wire 25 between the first blocking disk 21 and the second blocking disk 23, and thus the distance between the two blocking disks. The first plugging disc 21 comprises a first sleeve 214 arranged in its central region, and a first supporting skeleton 215; preferably, the first sleeve 214 is arranged in the geometric center of the first plugging disc 21; the first support armature 215 includes a plurality of support rings coupled to the first sleeve 214 and surrounding the first sleeve 214 to form the first support armature 215, and a first coil 217 wound on the first sleeve 214. It will be appreciated that in other embodiments the first sleeve 214 is provided at an eccentric position on the first blanking disc 21.

Preferably, the first coil 271 is disposed at the geometric center of the first blocking disk 21, the tightening wire 25 passes through the threading hole 270 of the first coil 271 and is tightened, and the intersection of the first coil 271 and the tightening wire 25 is located at the geometric center of the first blocking disk 21, so that the first blocking disk 21 is uniformly pulled, and when the length of the tightening wire 25 is adjusted after the first blocking disk 21 is positioned, the first blocking disk 21 is not easily deflected.

Preferably, the first sleeve 214 may be a steel sleeve with both ends open, and the first sleeve 214 may also be a combination of multiple steel sleeves. The first sleeve 214 has two oppositely disposed openings, and a cavity 2140 between the two openings; in one embodiment, the first coil 271 is a single coil that is suspended from the first sleeve 214 through both of the openings and the cavity 2140. In this embodiment, the cavity 2140 of the first sleeve 214 is a through hole extending along the thickness direction of the first blocking plate 21 (the direction perpendicular to the disc surface of the first blocking plate 21), the first coil 271 passes through the opening of the first sleeve 214 and the cavity 2140 and is connected to the circumferential wall of the first sleeve 214, the first coil 271 winds around the first sleeve 214 to form the threading hole 270, and the tightening wire 25 movably passes through the threading hole 270; when the tightening wire 25 is pulled toward the side away from the first support frame 215, the first sleeve 214 is subjected to a point of tension on the geometric center line of the first support frame 215. In this embodiment, the ends of the support rings are connected to the outer periphery of the first sleeve 214 and are fixedly connected to the first sleeve 214 by welding or bonding. The first sleeve 214 is made of stainless steel, nitinol, or other biocompatible material.

Specifically, the first coil 271 further includes a threading coil 2712 and a positioning coil 2714 connected to each other, the threading coil 2712 is annular and formed with a threading hole 270, and the positioning coil 2714 is wound on the first sleeve 214. The threading coil 2712 and the positioning coil 2714 may be formed of the same suture thread or two suture threads. In this embodiment, the first loop 271 is formed by a suture thread tied at a knot point 2715 and then encircled into a threading hole 270, and then both ends of the suture thread are wound around the outer surface of the first sleeve 214 and fixedly connected by knotting at a knot point 2716 to enclose a positioning loop 2714; the positioning coil 2714 comprises a suspension line segment 2717 arranged on the first sleeve 214 and two positioning line segments 2718 attached to the outer peripheral surface of the first sleeve 214; the positioning coil 2714 at least comprises two oppositely arranged suspension line segments 2717, and the suspension line segments 2717 are respectively positioned at two openings of the first sleeve 214; preferably, the flying line segment 2717 extends radially of the first sleeve 214 and passes through the geometric center of the first sleeve 214. The connection of the threading coil 2712 and the positioning coil 2714 is located on at least one of the flying segments 2717 of the positioning coil 2714, preferably at the midpoint of one of the flying segments 2717, and when the threading coil 2712 is straightened, the connection of the threading coil 2712 and the positioning coil 2714 and the threading coil 2712 are both located on the geometric center of the first sleeve 214.

In other embodiments, the positioning coil 2714 is a coil wound with a suture thread around the outer surface of the first sleeve 214 and tied to a fixed connection; the threading loop 2712 is a loop that is connected to the positioning loop 2714 by another suture knot.

As shown in fig. 1 to 3, the disc surfaces of the first blocking disc 21 and the second blocking disc 23 may be circular, polygonal, elliptical, triangular or other irregular shapes, and the radial dimension of the first blocking disc 21 may be the same as or different from the radial dimension of the second blocking disc 23, for example, the radial dimension of the first blocking disc 21 is smaller than the radial dimension of the second blocking disc 22. In the present embodiment, the first blocking disk 21 and the second blocking disk 23 are each substantially hexagonal disk-shaped, and the radial dimension of the first blocking disk 21 is equal to the radial dimension of the second blocking disk 23.

The support rings of the first support armature 215 include a first support ring 2151, the first support ring 2151 including a plurality of strands of woven wire, and the positioning coils 2714 are threaded through gaps between the plurality of strands of woven wire in the first support ring 2151 to securely position the positioning coils 2714 on the first sleeve 214. Preferably, the other end of the positioning coil 2714 also passes through the gap between the strands of the other support ring on the opposite side, so that the two sides of the positioning coil 2714 are positioned by the strands of the corresponding support ring, thereby making the positioning of the positioning coil more stable.

In this embodiment, the first blocking plate 21 further includes a first flow blocking film 218 disposed on the first supporting framework 215, the first flow blocking film 218 may be fixedly disposed on the inner surface and/or the outer surface of the first supporting framework 215 by sewing, bonding, or heat sealing, if the first supporting framework 215 is in a cage shape, the first flow blocking film 218 may also be fixedly disposed in the inner cavity of the first supporting framework 215, and the first flow blocking film 218 at least covers a part of the inner side surface or a part of the outer side surface of the first supporting framework 215. In this embodiment, the first flow blocking film 218 covers the surface of the first supporting framework 215 on the side facing away from the second blocking disk 23, i.e. the first flow blocking film 218 covers the outer side surface of the first blocking disk 21. The first sleeve 214 is disposed inside the first plugging disc 21, and the first flow blocking film 218 covers the opening of the first sleeve 214 facing the outside of the first plugging disc 21 to seal the opening of the cavity 2140 of the first sleeve 214 facing the outside of the first plugging disc 21. In this embodiment, the positioning coil 2714 passes through the gap between the first flow resistance membrane 218 and the first sleeve 214, and does not penetrate through the first flow resistance membrane 218, which is beneficial for maintaining the integrity of the first flow resistance membrane 218 and reducing the probability of residual shunt and breakage of the first flow resistance membrane 218 after the implantation of the occluder 20.

Optionally, the first sleeve 214 is a double-layer steel sleeve, and the end of the support ring is clamped in the gap between the two layers of steel sleeve, in the cavity in the inner and outer layers of steel sleeve.

In one embodiment, the positioning coil 2714 is adhesively positioned on the first flow resistance membrane 218 to prevent displacement of the positioning coil 2714; in one embodiment, the first flow blocking membrane 218 is disposed inside the first occluding disk 21, the first sleeve 214 is disposed inside or outside the first occluding disk 21, the positioning coil 2714 passes through the first flow blocking membrane 218, and a plurality of apertures are formed in the first flow blocking membrane 218 for passing therethrough. It is understood that in other embodiments, other connections between the positioning coil 2714 and the blocker film 218 may be used; in a modified embodiment, the first flow blocking film 218 is not provided.

As shown in fig. 1, the second blocking disk 23 has a similar structure to the first blocking disk 21, the second blocking disk 23 also having a central region 231 and edge regions 233 around the central region 231; the second plugging disc 23 comprises a second sleeve 234 arranged in the central region thereof and a second supporting skeleton 235 connected around the second sleeve 234, wherein the second sleeve 234 is fixedly arranged in the geometric center of the second plugging disc 23 in the present embodiment; a plurality of support rings in a second support frame 235 surround the second sleeve 234. It will be appreciated that in other embodiments, the second sleeve 234 is positioned off-center on the second blanking disc 23.

As shown in fig. 4, the second sleeve 234 has a structure similar to that of the first sleeve 214, and the second sleeve 234 may be a steel sleeve with two open ends or a combination of multiple steel sleeves. Specifically, the second sleeve 234 is cylindrical and has a cavity 2340, and both ends of the tightening wire 25 pass through the second blocking disk 23 from the inside to the outside, and specifically, both ends of the tightening wire 25 pass through different positions of the second blocking disk 23, respectively. Preferably, one end of the tightening wire 25 passes through the cavity 2340 of the second sleeve 234, and the other end of the tightening wire 25 passes through the mesh hole formed by the second support frame 235 around the second sleeve 234. In a modified embodiment, both ends of the tightening wire 25 pass through different meshes formed by the second support frame 235; in a modified embodiment, the second sleeve 234 has two cavities therein extending along its axis, with the two ends of the tightening wire 25 passing through different cavities in the second sleeve 234.

The ends of the support rings are fixedly disposed on the outer or inner circumferential surface of the second sleeve 234. In this embodiment, the second sleeve 234 is a double-layer steel sleeve, and the end of the support ring is clamped in the gap between the two layers of steel sleeve. And the cavity in the inner steel sleeve is used for penetrating the tightening wire. The second sleeve 234 is made of stainless steel, nitinol, or other biocompatible material. Preferably, on the second occluding disk 23, the second sleeve 234 is disposed outside the second occluding disk 23, i.e., outside the second support skeleton 235, the second flow-obstructing membrane 238 is disposed inside the second occluding disk 23, and the second flow-obstructing membrane 238 is disposed inside to facilitate tissue attachment.

In other embodiments, the ends of the support rings are fixedly attached to the outer or inner circumferential surface of the second sleeve 234 by welding or bonding.

The second blocking disk 23 further includes a second flow-blocking film 238 disposed on the second supporting skeleton 235, the second flow-blocking film 238 may be fixedly disposed on the inner surface and/or the outer surface of the second supporting skeleton 235, if the second supporting skeleton 235 is cage-shaped, the second flow-blocking film 238 may also be fixedly disposed in the inner cavity of the second supporting skeleton 235, and the second flow-blocking film 238 at least covers the radial region of the second supporting skeleton 235. In this embodiment, the second flow-blocking film 238 covers the surface of the second supporting skeleton 235 facing the first blocking disk 21, that is, the second flow-blocking film 238 covers the inner side surface of the second supporting skeleton 235; one end of the tightening wire 25 passes through the cavity 2340 of the second sleeve 234, and the other end of the tightening wire 25 passes through the mesh formed by the second support frame 235 and the corresponding area of the mesh on the second flow blocking film 238.

The first and second flow-blocking membranes 218 and 238 may be made of a biocompatible non-degradable polymer material such as ePTFE or PET; the first and second flow-blocking films 218 and 238 may also be made of absorbable polymer materials, such as polylactic acid, polycaprolactone, polylactic acid-caprolactone copolymer, etc. The first flow blocking membrane 218 and the second flow blocking membrane 238 are fixed to the inner surface or the outer surface of the blocking disk by sewing or gluing for blocking blood flow.

The first support frame 215 and the second support frame 235 may be woven mesh structures or cut frame structures so that the first occluding disk 21 and the second occluding disk 23 can be sufficiently attached to the surface of the atrial septum. The first supporting framework 215 and the second supporting framework 235 are respectively any one of a single-layer woven mesh structure, a single-layer frame structure, a double-layer mesh structure or a double-layer frame structure; in this embodiment, the first supporting framework 215 and the second supporting framework 235 are both single-layer woven mesh structures, and a plurality of the supporting rings are circumferentially arranged around the sleeve for at least one circle. Since in this embodiment the first sleeve 214 is arranged in the geometric center of the first blocking disk 21 and the second sleeve 234 is arranged in the geometric center of the second blocking disk 23, several of said support rings of the first blocking disk 21 are arranged circumferentially around the geometric center of the first sleeve 214 and several of the support rings of the second blocking disk 23 are arranged circumferentially around the geometric center of the second sleeve 234. In a preferred embodiment, the support rings on the first closing disk 21 and the second closing disk 23 are arranged at regular intervals.

As shown in fig. 2, in the present embodiment, the first supporting framework 215 includes 6 supporting rings, which are arranged along the geometric center of the first plugging disk 21 in the circumferential direction, and every two adjacent supporting rings are connected in a cross manner, and each two adjacent supporting rings have a connection point 2155. Specifically, the first support frame 215 further includes a second support ring 2152, a third support ring 2153, a fourth support ring, a fifth support ring, and a sixth support ring which are circumferentially arranged in a clockwise direction with the first support ring 2151 as a starting point, each support ring is formed by bending a support rod ring, ends of both ends of each support ring located in the central region 211 are fixedly connected to the first sleeve 214, and a portion of each support ring located in the edge region 213 is located at a radial edge of the first blocking disc 21. Taking the first support ring 2151 as an example, the first support ring 2151 is cross-connected to the second support ring 2152 and the sixth support ring, the end of the first support ring 2151 located in the central region 211 is connected to the first sleeve 214, and is respectively connected to the end of the third support ring 2153 located in the central region and the end of the fifth support ring located in the central region, that is, the first support ring 2151, the third support ring 2153 and the fifth support ring each have an end connection portion 2156, and the adjacent support rings are integrally connected at the end connection portion 2156, for example, the first support ring 2151 and the third support ring 2153 are integrally connected at the end connection portion 2156, the third support ring 2153 and the fifth support ring are integrally connected at the end connection portion 2156, and the first support ring 2151 and the fifth support ring are integrally connected at the end connection portion 2156.

As shown in fig. 2 and 5, the "cross-connection" between the first support ring 2151 and the second support ring 2152 means: at least one of the two adjacent support rings comprises a plurality of strands of knitting yarns, the plurality of strands of knitting yarns are in a winding and knitting or side-by-side arrangement relationship, and the other support ring is inserted into a gap of the plurality of strands of knitting yarns of the at least one support ring so as to enable the two adjacent support rings to be oppositely positioned; if the first support ring 2151 comprises a plurality of strands of woven filaments which are wound and woven or arranged side by side, the second support ring 2152 is inserted into the gaps of the plurality of strands of woven filaments of the first support ring 2151 at the intersection of the first support ring 2151 and the second support ring 2152; the second support ring 2152 is also formed by winding and weaving a plurality of strands of woven wires or arranging the strands of woven wires side by side, and the intersection of the second support ring 2152 and the third support ring 2153 is formed by inserting the third support ring 2153 into the gaps between the plurality of strands of woven wires of the second support ring 2152.

The intersection of the first support ring 2151 with the third and fifth support rings 2153 and 2156 is at an end connection 2156, and adjacent support rings are integrally connected at the end connection 2156. The end connection portions 2156 are located in the central region 211, and the two support rings are integrally wound and woven with the woven yarn of the end connection portions 2156. For example, the first support ring 2151 is integrally woven with the end connection 2156 of the third support ring 2153 in the central region 211, with the area of the two support rings woven with one another extending from the first sleeve 214 to a position where the two support rings are spaced apart from one another. In modified embodiments, the multiple braided wires of adjacent support rings in end connection 2156 are arranged side-by-side, or are tied together by suture wrapping, or are bonded together, or are welded together.

The connection points of the support rings of the first plugging disc 21, which are connected to one another crosswise, are situated further from the geometric center of the first plugging disc 21 than the connection points which are woven integrally with one another.

In a modified embodiment, the connection points of the first closing disk 21 where the support rings are connected to each other in a crossing manner are closer to the geometric center of the first closing disk 21 than the connection points where the support rings are integrally woven.

In a modified embodiment, all the connection points between the support rings on the first plugging disc 21 are connected to each other by crossing, or all the connection points between the support rings on the first plugging disc 21 are connected to each other by weaving.

In a modified embodiment, at least some of the connecting points between the support rings on the first occluding disk 21 are connected to each other in a cross-over manner, or at least some of the connecting points between the support rings on the first occluding disk 21 are connected to each other in a woven manner.

In this embodiment, each of the support rings is formed by winding and weaving a plurality of weaving wires or is arranged side by side, that is, the first to sixth support rings are formed by winding and weaving a plurality of weaving wires, it is understood that, in the modified embodiment, a part of the support rings in the first plugging disc 21 include a plurality of weaving wires, and the other support rings in the first plugging disc 21 include a plurality of weaving wires.

The structure of the second supporting framework 235 is the same as that of the first supporting framework 215, and thus the description thereof is omitted.

The support rings of the first support skeleton 215 and the second support skeleton 235 may each be made of various biocompatible materials, i.e., each support ring may be made of various biocompatible materials, including materials commonly used in the manufacture of releasable medical devices, such as memory alloy materials, preferably nitinol; the first support skeleton 215 and the second support skeleton 235 may also be made of degradable material, i.e. each support ring is made of degradable material, such as polylactic acid PLA, polycaprolactone PCL, polyglycolide PGA, or poly-p-dioxanone PDO; the first supporting framework 215 and the second supporting framework 235 may also be made of high polymer materials.

As shown in fig. 2, the connecting member 27 further includes at least one second coil 273, the at least one second coil 273 is disposed on one side of the first plugging disk 21 facing the second plugging disk 23 (the inner side of the first plugging disk 21) and surrounds the first coil 271, the at least one second coil 273 is annular and forms a threading hole 270, and the tightening thread 25 is inserted into the threading holes 270 of the first coil 271 and the second coil 273. In this embodiment, the middle portion of one side of the first blocking disc 21 facing the second blocking disc 23 is provided with the first coil 271, and a plurality of second coils 273 around the first coil 271 are arranged, preferably, the plurality of second coils 273 are uniformly arranged at least one circle around the first coil 271, so as to improve the uniformity of the stress of the first blocking disc 21 during the process of taking up and paying off the tightening wire 25. In other modified embodiments, the plurality of second coils 273 are not limited to be uniformly spaced.

Specifically, the first coil 271 is a center coil located at the geometric center of the first blocking disk 21, which means the coil closest to the geometric center of the first blocking disk 21 out of the first coil 271 and the second coil 273; the number of the second coils 273 is three, the three second coils 273 are arranged along the geometric center of the first sleeve 214 in an annular array, each second coil 273 is fixedly connected to the first support frame 215, and the tightening wire 25 is inserted into the first coil 271 and each second coil 273. In a modified embodiment, one of the second coils 273 is a center coil.

The second coil 273 is connected to the first support frame 215; specifically, the second coil 273 may be connected to the first support frame 215 by knotting, may be sandwiched between multiple strands of woven filaments at the intersection of two adjacent support rings in the first support frame 215, and may be glued to the first support frame 215.

Preferably, the second coil 273 is disposed at the intersection of two adjacent support rings, such as a connection point 2155 or an end connection 2156 on a support ring. Specifically, in the present embodiment, as shown in fig. 2, the second coils 273 are respectively provided at the intersection of the ends of the first support ring 2151 and the third support ring 2153, the intersection of the ends of the first support ring 2151 and the fifth support ring, and the intersection of the ends of the third support ring 2153 and the fifth support ring, so that the three second coils 273 are uniformly surrounded around the first sleeve 214.

The second coil 273 is inserted through a slot at the intersection of the two support rings. As shown in fig. 5, a second coil 273 is provided at the intersection of the end of the first support ring 2151 and the end of the third support ring 2153; specifically, the second coil 2712 is inserted into the end connection portions 2156 of the first and third support rings 2151 and 2153, the plurality of woven filaments in the first and third support rings 2151 and 2153 in the end connection portions 2156 are integrally woven with each other, and the second coil 2712 is inserted through a gap between the plurality of woven filaments in the end connection portions 2156 to position the second coil 2712 on the first support frame 215. As shown in fig. 5, in the present embodiment, the second coil 2712 is connected to the end connecting portions 2156 of the two support rings at a position farther from the first sleeve 214, and in the modified embodiment, the second coil 2712 is connected to the end connecting portions 2156 of the two support rings at a position closer to the first sleeve 214 or is provided in the middle of the end connecting portions 2156. It will be appreciated that in alternate embodiments, the second coil 273 may also be located at the connection point 2155 of the cross-connection between adjacent support rings, such as the connection point 2155 of the first and second support rings 2151, 2152 described above.

As shown in fig. 6, the first coil 271 and each second coil 273 are surrounded by a suture thread through several consecutive knotting manners as shown in fig. 6, so that the knotted portions of the first coil 271 and the second coil 273 are firmly connected, and thus the first coil 271 and each second coil 273 are stably maintained in a circular state, which facilitates the insertion of the tightening wire 25. The knotting manner in fig. 6 means that the braided wire for enclosing the first wire loop 271 or the second wire loop 273 is first wound around a connecting ring 2732, and then one end of the braided wire is passed through the connecting ring 2732 to form a fixed knot.

As shown in fig. 1 and 7, the two ends of the tightening wire 25 are respectively an adjusting section 251 and a locking section 253, the adjusting section 251 or the locking section 253 includes a centering section 254, and the centering section 254 is connected between the first coil 271 and the second plugging disc 23. The adjusting segment 251 and the locking segment 253 form an adjusting knot 250 after passing through the second closing disk 23 on the side facing away from the first closing disk 21 (outside of the second closing disk 23). The end of the adjustment segment 251 passes through the adjustment knot 250, and the adjustment segment 251 is locked by locking the adjustment knot 250, so that the tightening thread 25 fixes the interval between the first closing disk 21 and the second closing disk 23. Wherein, the centering section 254 is connected between first shutoff dish 21 and second shutoff dish 23, preferably, at first shutoff dish 21 and the inboard of second shutoff dish 23, the one end interlude of centering section 254 keeping away from second shutoff dish 23 is in threading hole 270 of first coil 271 and threading hole 270 of second coil 273, when taut string 25 of tightening, through taut first coil 271 to middle section 254, makes first shutoff dish 21 atress central, conveniently controls the position of first shutoff dish 21.

In a modified embodiment, one of the second coils 273 may be a center wire loop.

In a modified embodiment, the adjustment segment 251 and the locking segment 253 each include a pair of intermediate segments 254, with the two pairs of intermediate segments 254 exiting from a central loop.

In the modified embodiment, neither end of the tightening wire 25 is threaded out of the center coil.

Specifically, as shown in fig. 7, the locking segment 253 includes a free end 2530, and the adjustment segment 251 includes a free end 2510; the locking segment 253, the adjusting segment 251 and the adjusting knot 250 are all arranged on one side of the second plugging disc 23 departing from the first plugging disc 21, and the length of the centering segment 254 can be adjusted through the adjusting segment 251. The free end 2530 of the locking segment 253 and the free end 2510 of the adjusting segment 251 are connected to the conveyor 50, and by controlling the conveyor 50 to pull the free end 2510 to move proximally, the tightening wire 25 slides in the axial direction of the second plugging disc 23 (such as in the cavity 2340 and the mesh hole between the second supporting frames in the embodiment) and in the threading holes 270 of the first coil 271 and the second coil 273, so as to shorten the length of the tightening wire between the first plugging disc 21 and the second plugging disc 23, and further adjust the waist length of the plugging device 20; the free end 2530 is pulled to move towards the near end by controlling the conveyor 50, so that the adjusting wire knot 250 is locked, the adjusting wire knot 250 is locked to lock the adjusting section 251, the distance between the first blocking disc 21 and the second blocking disc 23 is relatively fixed, the distance between the first blocking disc 21 and the second blocking disc 23 is fixed, the relative positions and the close state of the primary diaphragm, the secondary diaphragm and the two blocking discs are kept in an operation and after the operation, the withdrawing difficulty of the conveyor 50 is reduced, and the permanent endothelialization of the two postoperative diaphragms to the occluder 20 is facilitated to form the atrial septal.

One end of the adjustment wire loop 250 is connected to the portion of the locking segment 253 adjacent to the second blocking disk 23 and the other end of the adjustment wire loop 250 is connected to the free end 2530 remote from the second blocking disk 23. When the adjusting knot 250 is not tightened, the free end 2510 can drive the adjusting section 251 connected with the free end to slide in the adjusting knot 250 so as to adjust the length of the centering section 254 between the first blocking disk 21 and the second blocking disk 23; the free end 2530 of the locking segment 253 is used to tighten the adjustment knot 250 so that the adjustment knot 250 tightens the portion of the adjustment segment 251 located therein to fix the length between the first occluding disk 21 and the second occluding disk 23.

As shown in fig. 7, the adjusting knot 250 includes a base wire loop 2501 and a locking wire loop 2503 connected to each other, and the base wire loop 2501 and the locking wire loop 2503 are formed by winding and knotting the locking segment 253. Specifically, one end of the base wire loop 2501 and one end of the locking wire loop 2503 are connected to a whole, one end of the base wire loop 2501 away from (or not connected to) the locking wire loop 2503 extends to the second blocking plate 23, one end of the locking wire loop 2503 away from (or not connected to) the base wire loop 2501 is a free end 2530, and a free end 2510 of the adjusting segment 251 is inserted into the base wire loop 2501 and the locking wire loop 2503; when the base wire loop 2501 and the locking wire loop 2503 are not tightened, the free end 2510 can drive the adjusting section 251 to slide in the adjusting knot 250 so as to adjust the length of the centering section 254 between the first blocking disk 21 and the second blocking disk 23; when the free end 2530 of the locking segment 253 is pulled, the locking wire loop 2503 and the base wire loop 2501 are successively tightened, so that a portion of the adjustment segment 251 is tightly locked in the locking wire loop 2503.

As shown in fig. 1, during use, the first occluding disk 21 is delivered from and deployed in the left atrium by the delivery device 50, and the second occluding disk 23 is delivered to and deployed in the right atrium by the delivery device 50. The centering section 254 connected between the first blocking disc 21 and the second blocking disc 23 is flexible and adjustable in length, and the centering section 254 penetrates through an oval hole between the primary diaphragm and the secondary diaphragm; the free end 2510 of the adjusting section 251 is pulled towards the proximal end, the centering section 254 is tensioned, the centering section 254 is located on the geometric center of the first occluding disk 21, and the centering section 254 is gradually shortened, namely, the distance between the first occluding disk 21 and the second occluding disk 23 is gradually reduced, the primary diaphragm and the secondary diaphragm are close to each other and are clamped by the first occluding disk 21 and the second occluding disk 23, the primary diaphragm and the secondary diaphragm are covered by the first occluding disk 21 around the foramen ovale, and the primary diaphragm and the secondary diaphragm are covered by the second occluding disk 23 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 occluding disk 21 and the second occluding disk 23. Because first shutoff dish 21 and second shutoff dish 23 all include the support chassis and set up the choked flow membrane on the support chassis, the choked flow membrane of oval hole both sides can prevent blood to flow in the oval hole to avoided the blood flow to flow in the right atrium from the left atrium, in order to realize instant shutoff. After the occluder 20 is implanted, the primary diaphragm and the secondary diaphragm crawl to the contact positions of the first occluding disk 21 and the second occluding disk 23 to close the foramen ovale after endothelialization is completed, and a complete atrial septum is formed. In a modified embodiment, the density of the supporting frameworks on the two plugging discs is high enough, and the flow-resisting film is omitted, so that endothelialization of the two diaphragms to the plugging discs is not influenced, and shunting cannot be formed or shunting is small on the oval hole channel.

As shown in fig. 8, the structure of another embodiment of the first plugging disk 21a of the present invention is similar to that of the first plugging disk 21 in one of the above embodiments, except that: all the second coils 273 are omitted on the basis of the first blocking disk 21, that is, the connecting piece of the first blocking disk 21a only retains the first coil 271, the tightening wire 25 is inserted into the threading hole 270 of the first coil 271, and when the tightening wire 25 is pulled towards the proximal end, the tightening wire 25 can slide in the first coil 271, thereby assisting in realizing the adjustment of the distance between the two blocking disks.

As shown in fig. 9, the structure of the first plugging disk 21b according to another embodiment of the present invention is similar to that of the first plugging disk 21 in one of the above embodiments, except that: the connecting element of the first closing disk 21b comprises a first coil 271 and two second coils 273, the first coil 271 being arranged in the geometric center of the first closing disk 21b, the two second coils 273 being arranged on the first closing disk 21b and being arranged symmetrically with respect to the geometric center of the first closing disk 21 b. In this embodiment, one second coil 273 is connected to the intersection of the ends of the first and fifth support rings 2151, the other second coil 273 is connected to the end connecting portion 2156 of the second and fourth support rings 2152 and 2156, and each second coil 273 is inserted into the gap of the knitting yarn of the corresponding support ring, so that the second coil 273 is fixedly connected to the first blocking disk 21 b. The tightening thread 25 is inserted through the threading hole 270 of the first coil 271 and the threading holes 270 of the respective second coils 273.

As shown in fig. 10, the structure of the first plugging plate 21c according to another embodiment of the present invention is similar to that of the first plugging plate 21 in one of the above embodiments, except that: the connecting member of the first plugging disk 21c includes a first coil 271 and six second coils 273, the first coil 271 is disposed at the geometric center of the first plugging disk 21c, and the six second coils 273 are arranged in a circle in an annular array with the geometric center of the first plugging disk 21 c. In this embodiment, the second coil 273 is connected to the end connection portions 2156 of every two adjacent support rings 2151, specifically, the second coils 273 are respectively disposed at the end connection portions 2156 of the first and third support rings 2151 and 2153, the end connection portions 2156 of the first and fifth support rings 2151 and 2156, the end connection portions 2156 of the second and fourth support rings 2152 and 2152, the intersection of the ends of the second and sixth support rings, the end connection portions 2156 of the third and fifth support rings 2153 and the end connection portions 2156 of the fourth and sixth support rings 2156. Each second coil 273 is inserted into the gaps of the weaving wire of the corresponding support ring so that each second coil 273 is fixedly connected to the first blocking disk 21 c. The tightening wire 25 is inserted through the threading hole 270 of the first coil 271 and the threading holes 270 of the respective second coils 273. As shown in fig. 11, the structure of the first support frame 215a in the present embodiment is similar to that of the first support frame 215 shown in fig. 5 described above, except that: the adjacent support rings are mutually inserted and connected at the intersection of the central area and the edge area; specifically, the first support ring 2151 and the third support ring 2153 are located on opposite sides of the second support ring 2152, the end of the first support ring 2151 intersects with the end of the third support ring 2153 to be inserted into each other, and the first support frame 215a is spaced apart from the intersection of the end of the first support ring 2151 and the end of the third support ring 2153 to form a mesh; in this embodiment, the end of the first support ring 2151 is inserted into the gap between the ends of the plurality of braided wires of the third support ring 2153. In other embodiments, the end of the third support ring 2153 may also be inserted into the interstices of the plurality of braided wires at the end of the first support ring 2151; or a portion of the braid filaments at the end of the first support ring 2151 are inserted into the interstices of the plurality of braid filaments at the end of the third support ring 2153. Preferably, all of the intersections between the support rings on the first support frame 215a are in an interpenetrating relationship.

As shown in fig. 12, the structure of the first support frame 215b in the present embodiment is similar to that of the first support frame 215a shown in fig. 11 described above, except that: the second coil 273 is inserted into the mesh 2158 formed at the position where the first support ring 2151 and the third support ring 2153 are inserted into each other. Specifically, 4 meshes 2158a, 2158b, 2158c and 2158d are formed around the insertion connection position of the first support ring 2151 and the third support ring 2153, wherein the meshes 2158a and the meshes 2158c are arranged oppositely, the meshes 2158b and the meshes 2158d are arranged oppositely, the meshes 2158c are enclosed by the first support ring 2151 and the third support ring 2153 and are located in the central area, the meshes 2158a are arranged far away from the first sleeve 214 relative to the meshes 2158c, and the meshes 2158b and the meshes 2158d are sandwiched between the meshes 2158a and the meshes 2158c from both sides. The second coil 273 is interspersed between the mesh holes 2158a and 2158c, and the second coil 273 spans the intersection of the first support ring 2151 and the third support ring 2153, thereby preventing the second support ring 273 from being unable to shift on the first support skeleton.

In other embodiments, the first supporting framework 215 and the second supporting framework 235 are generally woven by 4-50 supporting rings, and meshes are formed between adjacent supporting rings. In the following description, taking the first supporting framework 215 as an example, the following technical solutions are also applicable to the second supporting framework 235: the first support frame 215c in fig. 13 is formed by arranging 30 circular support rings in a circumferential row along the axial center of the first sleeve 214, the first support frame 215d in fig. 14 and 15 is formed by arranging 6 circular support rings in an annular array along the axial center of the first sleeve 214, and the first support frame 215d in fig. 15 is provided with a first flow blocking film 218.

In other embodiments, each of the support rings may be oval, semi-circular, irregular, etc. As shown in fig. 16, the first supporting frame 215e is formed by a plurality of oval supporting rings annularly arrayed along the geometric center of the first sleeve 214, one end of each supporting ring is connected to the first sleeve 214, and the inner surface and/or the outer surface of the first supporting frame 215e is provided with the flow blocking film. As shown in fig. 17, the first support frame 215f is formed by a plurality of semicircular support rings annularly arrayed along the geometric center of the first support frame 215f, one end of each support ring being connected to the first sleeve 214; the inner surface and/or the outer surface of the first support skeleton 215f is provided with the flow blocking film. As shown in fig. 18, the first support frame 215h is formed by a plurality of irregularly shaped support rings annularly arrayed along the geometric center of the first support frame 215h, one end of each support ring being connected to the first sleeve 214; the inner surface and/or the outer surface of the first support skeleton 215h is provided with the flow blocking film.

The tightening thread 25 and the connecting member may be non-absorbable biocompatible suture, such as metal thread, cotton thread, polyester, polypropylene, etc., the tightening thread 25 and the connecting member may be absorbable biocompatible suture, such as catgut, polyglycolide, multifilament non-biodegradable suture, etc., and the tightening thread 25 may be a force-wound fiber thread, etc.

In the present embodiment, the tightening wire 25 is a PTFE suture, which has high toughness and high mechanical strength, or is made of degradable PGA, PGLA, PLA, collagen, nylon suture, polyester suture, or the like. The material used for the connecting member 27 is PP material, which has good tensile strength and hardness, and PET, ePTFE or the material used for the above-mentioned diameter-adjusting wire can also be used. In this embodiment, the connecting member 27 is a double-strand suture, so that the occluder has better connection strength. In other embodiments, more than one strand of suture, or one strand of suture, may be used for the attachment 27.

The plugging system 100 of the present invention needs to be used in cooperation with a guide wire, a conveyor 50, a dilator, etc. during use. The operation process is as follows:

1. placing the guide wire into the left superior pulmonary vein, reserving the guide wire, placing the delivery sheath and the dilator into the middle part of the left atrium, and withdrawing the dilator and the guide wire;

2. keeping the conveying sheath pipe still, inserting a conveying rod of a conveyor 50 loaded with the first blocking disc 21 and the second blocking disc 23 into the rear end of the conveying sheath pipe, then pushing the conveyor forwards, and firstly pushing the front end of the conveying rod out of the conveying sheath pipe;

3. releasing the first occluding disk 21 relatively far from the delivery device 50 in the left atrium until the first occluding disk 21 is deployed in the left atrium; the delivery sheath is then withdrawn with the transporter 50, releasing the second occluding disk 23 as the delivery sheath is withdrawn into the right atrium until the second occluding disk 23 is deployed in the right atrium; at this time, the adjustment knot 250 is in a slack state, the base wire loop 2501, the locking wire loop 2503, and the adjustment knot 250 are all in a slack state, and the respective wire loops are not tightened.

4. The second plugging disc 23 is fixed at the far end of the conveying sheath, the free end 2510 of the adjusting section 251 is pulled towards the near end through the conveyor 50, the centering section 254 is straightened and the length of the centering section 254 is reduced, and the first plugging disc 21 and the second plugging disc 23 are driven to move relative to the atrium at intervals until the inner side of the first plugging disc 21 is attached to one side of the atrium interval around the foramen ovale and the inner side of the second plugging disc 23 is attached to the other side of the atrium interval around the foramen ovale;

5. when the atrial septum around the foramen ovale is firmly clamped by the first and second sealing discs 21, 23, the conveyor 50 pulls the free end 2530 of the locking segment 253 proximally, so that the locking wire loop 2503 is gradually tightened, the tightening of the locking wire loop 2503 drives the foundation wire loop 2501 to be also locked, finally, the locking wire loop 2503 and the foundation wire loop 2501 are both tightened, so that the adjusting segment 251 is tightly locked by the locking wire loop 2503 and the foundation wire loop 2501 and is fixed between the locking wire loop 2503 and the foundation wire loop 1, and the length of the tightening wire 25 between the first and second sealing discs 21, 23 is fixed, so that the atrial septum is clamped by the first and second sealing discs 21, 23.

6. After knotting is completed, the thread cutter is pushed to the right atrium through the conveying sheath tube, a suture is cut at a position 3-5 mm away from the thread end, the conveying sheath tube and the thread cutter are withdrawn, and plugging of the oval hole is completed.

For convenience of description, the above method steps all use sequence numbers, and it should be noted that the above sequence numbers are not used to limit the context between the steps; the specific technical solutions in the above embodiments can be applied to each other without departing from the spirit of the present invention.

The above is an implementation manner of the embodiments of the present invention, and it should be noted that, for those skilled in the art, a plurality of improvements and decorations can be made without departing from the principles of the embodiments of the present invention, and these improvements and decorations are also considered as the protection scope of the present invention.

Claims (22)

1. An occluding device for occluding a defect in a vasculature, the occluding device comprising:

the first plugging disc and the second plugging disc are respectively used for covering different openings of the defect, a connecting piece is arranged on the first plugging disc, and a threading hole is formed in the connecting piece; and

the tightening line penetrates through the threading hole of the connecting piece, two ends of the tightening line penetrate through the second plugging disc, an adjusting knot is formed on one side, deviating from the first plugging disc, of the second plugging disc, and the distance between the first plugging disc and the second plugging disc can be adjusted through the end portion of the tightening line.

2. The occlusion device of claim 1, wherein the first occlusion disk includes a central region and an edge region at an edge of the central region, the connector including a first loop disposed in the central region, the first loop being annular and forming the threading aperture, the cinch cord passing through the threading aperture of the first loop.

3. The occlusion device of claim 2, wherein the first coil is disposed at a geometric center of the first occluding disk.

4. The occlusion device of claim 2, wherein the first occlusion disk comprises a first sleeve and a first support backbone, the first sleeve being cylindrical, the first support backbone comprising a plurality of support rings connected to one another, ends of the plurality of support rings being captured in the first sleeve, the first coil being wound around the first sleeve.

5. The occluder of claim 4, wherein the first sleeve has two oppositely disposed openings and a cavity therebetween, the first coil being suspended from the first sleeve through the two openings and the cavity.

6. The occlusion device of claim 4, wherein the first sleeve has two oppositely disposed openings and a cavity therebetween, the first coil comprising a threading coil and a positioning coil connected to each other, the threading coil being annular and defining the threading aperture, the positioning coil being wound around the first sleeve.

7. The occluder of claim 6, wherein a first support ring of said plurality of support rings comprises a plurality of braided wires, said positioning coil passing through a slit between said plurality of braided wires in said first support ring.

8. The occlusion device of claim 4, wherein the connector further comprises at least one second coil disposed on a side of the first occlusion disk facing the second occlusion disk and disposed around the first coil, the at least one second coil being annular and defining the threading hole, the tightening wire being threaded through the threading holes of the first and second coils.

9. The occlusion device of claim 8, wherein a coil of the first and second coils closest to the geometric center of the first occlusion disk is a center coil, wherein the two ends of the cinch wire are an adjustment section and a locking section, respectively, and wherein the adjustment section and/or the locking section comprises a centering section, and wherein the centering section is connected between the center coil and the second occlusion disk.

10. The occluding device of claim 8, wherein the first occluding disk is provided with a plurality of second coils, the plurality of second coils being evenly arranged at least one turn around the first coil.

11. The occlusion device of claim 8, wherein the second coil is connected to the first support scaffold.

12. The occlusion device of claim 11, wherein two adjacent support rings intersect, at least a second coil being disposed at the intersection of the two support rings.

13. The occlusion device of claim 12, wherein the intersections of two of said support rings are woven together and said second loop is inserted through a slit at the intersection of two of said support rings.

14. The occlusion device of claim 13, wherein the two support rings are a first support ring and a second support ring, the first support ring comprising a plurality of braided wires, the second support ring being inserted into a gap between the plurality of braided wires of the first support ring, a second coil being disposed through the gap.

15. The occluding device of claim 4, wherein the two ends of the cinch cord pass through different locations of the second occluding disk.

16. The occluder of claim 15, wherein the second occluding disk comprises a central region and an edge region at the edge of the central region, the second occluding disk comprising a second sleeve and a second support frame, the second support frame having an end portion at the central region of the second occluding disk received in the second sleeve, the second sleeve being cylindrical and having a cavity, one end of the tightening wire passing through the cavity of the second sleeve, the other end of the tightening wire passing through a mesh formed by the second support frame around the second sleeve.

17. The occlusion device of claim 16, wherein the first occlusion disk comprises a first flow-blocking membrane covering the first support scaffold; and/or the second plugging disc comprises a second flow resistance film covering the second supporting framework.

18. The occlusion device of claim 16, wherein the first occlusion disc comprises a first flow-blocking membrane covering a surface of the first support scaffold on a side facing away from the second occlusion disc; and/or the second plugging disc comprises a second flow blocking film, and the second flow blocking film covers the surface of one side, facing the first plugging disc, of the second supporting framework.

19. The occlusion device of claim 8, wherein the first loop and each second loop are defined by a suture thread formed by a plurality of consecutive knots.

20. The occlusion device of claim 1, wherein the tightening line comprises a locking segment and an adjustment segment at opposite ends, the adjustment knot is connected to the locking segment at a side of the second occlusion disk facing away from the first occlusion disk, and the adjustment segment is slidably insertable into the adjustment knot.

21. The occluder of claim 20, wherein said adjustment knot comprises a base wire loop and a locking wire loop connected to each other, an end of said base wire loop distal from said locking wire loop being connected to said locking segment, an end of said locking wire loop distal from said base wire loop being connected to a free end of said locking segment, a free end of said adjustment segment being interpenetrated within said base wire loop and said locking wire loop; when the free end of the locking segment is pulled, the locking wire ring and the basic wire ring are sequentially and gradually tightened, so that the adjusting segment is tightly locked in the locking wire ring.

22. A plugging system comprising the plugging device of any one of claims 1 to 21, further comprising a conveyor for connecting the tightening line and controlling the end of the tightening line to adjust the spacing between the first plugging disk and the second plugging disk.

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