CN113876369A

CN113876369A - Occluder and Occlusion System

Info

Publication number: CN113876369A
Application number: CN202010625425.7A
Authority: CN
Inventors: 陈杰; 赵江浪; 程晓阳; 王永胜
Original assignee: Hangzhou Nuomao Medical Technology Co ltd
Current assignee: Hangzhou Nuomao Medical Technology Co ltd
Priority date: 2020-07-01
Filing date: 2020-07-01
Publication date: 2022-01-04

Abstract

The invention provides an occluder which is used for occluding defects in a vascular system and comprises a first occluding disk and a second occluding disk which are connected with each other, wherein the first occluding disk comprises a first supporting framework, and the first supporting framework comprises a plurality of supporting pieces which are arranged along the circumferential direction of the first occluding disk; the support pieces comprise a first support piece and a second support piece which are arranged adjacently, the first support piece comprises a plurality of strands of first weaving wires, the second support piece comprises at least one strand of second weaving wire, and at least part of the second weaving wires in the second support piece are inserted into first gaps formed among the plurality of strands of first weaving wires. The invention also provides a plugging system provided with the plugging device.

Description

Plugging device and plugging system

Technical Field

The invention relates to the field of medical instruments, in particular to an occluder and an occlusion system for occluding defects in a human body.

Background

The foramen ovale is the physiologic channel through which umbilical vein blood flows from the right atrium to the left atrium during fetal life to maintain fetal blood circulation, and after birth, the foramen ovale valve automatically closes with the formation of pulmonary circulation, and about 25% of infants develop cellulose attachment to permanently close by age 1 or so after birth, and if the potential interatrial channel remains after age 3, it is called Patent Foramen Ovale (PFO).

The patent foramen ovale is the abnormal traffic of crack-like abnormal traffic which is remained between the primary diaphragm and the secondary diaphragm and has the length of about 7mm and the width of about 1-6 mm, and is similar to a functional valve, and the natural adhesion and fusion of the primary diaphragm and the secondary diaphragm cannot be realized. When the right pressure is higher than the left pressure, the weak primary septum on the left side is pushed open, i.e. a right-to-left shunt occurs. Among the various common congenital heart diseases, right-to-left patent foramen ovale is the most common. In recent years, importance has been placed on the relationship between patent foramen ovale and ischemic stroke, decompression sickness, migraine and the like of unknown origin, and this is considered to be a new risk factor for the development of ischemic cerebral infarction particularly in young people. For patients with patent foramen ovale, interventional therapy has gradually replaced surgery and drug therapy as the first choice for clinical treatment. Research proves that percutaneous blockage of patent foramen ovale is a safe and effective treatment means with low complication and better clinical follow-up result.

At present, commercial non-degradable occluders appearing at home and abroad are mainly occluders made of metal alloy materials and non-degradable high polymer fabrics. However, the fixing of the connecting point of the alloy occluder is often carried out by means of later sewing with a membrane, and the connecting point of the fixing way has the risk of abrasion and falling off.

Disclosure of Invention

The invention provides an occluder which is used for occluding defects in a vascular system and comprises a first occluding disk and a second occluding disk which are connected with each other, wherein the first occluding disk comprises a first supporting framework, and the first supporting framework comprises a plurality of supporting pieces which are arranged along the circumferential direction of the first occluding disk; the support pieces comprise a first support piece and a second support piece which are arranged adjacently, the first support piece comprises a plurality of strands of first weaving wires, the second support piece comprises at least one strand of second weaving wire, and at least part of the second weaving wires in the second support piece are inserted into first gaps formed among the plurality of strands of first weaving wires.

The invention also provides a plugging system, which comprises a plugging device and a conveyor, wherein the plugging device comprises a first plugging disc and a second plugging disc which are connected with each other, the first plugging disc comprises a first supporting framework, and the first supporting framework comprises a plurality of supporting pieces which are arranged along the circumferential direction of the first plugging disc; the supporting pieces comprise a first supporting piece and a second supporting piece which are arranged adjacently, the first supporting piece comprises a plurality of strands of first braided wires, the second supporting piece comprises at least one strand of second braided wires, at least part of the second braided wires in the second supporting piece are inserted into first gaps formed among the strands of first braided wires, and the conveyor is used for releasing the occluder.

The plurality of supporting pieces of the occlusion system comprise a first supporting piece and a second supporting piece which are adjacently arranged, the first supporting piece comprises a plurality of strands of first braided wires, the second supporting piece comprises at least one strand of second braided wire, and at least part of second braided wires in the second supporting piece are inserted into first gaps formed among the strands of first braided wires, so that the first supporting piece and the second supporting piece are mutually inserted and connected into a whole, the fixation of the first supporting piece and the second supporting piece by using a suture is reduced or avoided, the connection of the first supporting piece and the second supporting piece is firmer, and the reliability and the safety of the occlusion device are improved.

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 it is obvious for those skilled in the art to obtain other drawings based on these drawings without creative efforts.

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

Fig. 2 is an enlarged view of the inside of the first occluding disk of the occluding system of fig. 1.

Fig. 3 is a schematic structural diagram of a connection mode at the intersection of two adjacent support rings in fig. 2.

Fig. 4 is a schematic structural diagram of another connection mode at the intersection of two adjacent support rings in fig. 2.

Fig. 5 is a schematic side view of a first support scaffold in a first occluding disk of the occluding system of fig. 1.

Fig. 6 is a schematic perspective view of an occluding device of an occluding system according to another embodiment of the invention.

FIG. 7 is a schematic view of another connection of several support rings of the occlusion system of the present invention.

Figure 8 is a schematic view of another configuration of the support framework of the occlusion system of the present invention.

Figure 9 is a schematic view of another configuration of the support framework of the occlusion system of the present invention.

Fig. 10 is a schematic view of another configuration of the occluding disk of the occluding system of the present invention.

Fig. 11 is a schematic view of another configuration of the occluding disk of the occluding system of the present invention.

Fig. 12 is a schematic view of another configuration of the occluding disk of the occluding system of the present invention.

Fig. 13 is a schematic view of another configuration of the occluding disk of the occluding system of the present invention.

Fig. 14 is a schematic view of another configuration of the occluding disk of the occluding system of the present invention.

Fig. 15 is a schematic view of another configuration of the occluding disk of the occluding system of the present invention.

Detailed Description

The technical solutions in the embodiments of the present invention will be clearly and completely described below with reference to the drawings in the embodiments of the present invention, and it is obvious that the described embodiments are only a part of the embodiments of the present invention, and not all of the embodiments. All other embodiments, which can be obtained by a person skilled in the art without inventive effort based on the embodiments of the present invention, are within the scope of the present invention.

Furthermore, the following description of the various embodiments refers to the accompanying drawings, which illustrate specific embodiments in which the invention may be practiced. In the present invention, the end relatively farther from the operator is the distal end, and the end relatively closer to the operator is the proximal end. Directional phrases used in this disclosure, such as, for example, "upper," "lower," "front," "rear," "left," "right," "inner," "outer," "side," and the like, refer only to the orientation of the appended drawings and are, therefore, used herein for better and clearer illustration and understanding of the invention, and do not 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 are therefore not to be considered limiting of the invention.

Referring to fig. 1 and 2, the present invention provides an occlusion system 100 comprising an occluding device 20 and a delivery device for releasing the occluding device 20, wherein the occluding device 20 is used to occlude defects in the vasculature, including but not limited to, foramen ovale, ductus arteriosus, atrial septal defects, ventricular septal defects, and the like, and the advantages of the occlusion system 100 in treating patent foramen ovale are illustrated herein by way of example of the defect being a foramen ovale, it being understood that the defect can 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 25, the first occluding disk 21 and the second occluding disk 23 are respectively used for covering different openings of defects in the vascular system; first shutoff dish 21 includes first support skeleton 210, and second shutoff dish 23 includes second support skeleton 230, and first support skeleton 210 includes a plurality of support piece along first shutoff dish 21 circumference setting, and second support skeleton 230 includes a plurality of support piece along second shutoff dish 23 circumference setting. Preferably, a plurality of the supporting members are arranged along the geometric center of the first supporting skeleton 210 in a circular array.

In this embodiment, the plurality of support members include a first support member 212 and a second support member 214 which are adjacently disposed, the first support member 212 includes a plurality of strands of first braided filaments 2121, the second support member 214 includes at least one strand of second braided filament 2141, at least a portion of the second braided filament 2141 in the second support member 214 is inserted into a first gap 2123 formed between the plurality of strands of first braided filaments 2121, so that the first support member 212 and the second support member 214 are integrally connected to each other in an inserting manner, and a mutual constraint and fixation effect is achieved, and the use of a suture for fixing the first support member 212 and the second support member 214 is reduced or avoided, so that the connection between the first support member 212 and the second support member 214 is firmer, and the reliability and the safety of the occluder 20 are improved.

In the present application, at least the first support member 212 of the plurality of support members of the first plugging disk 21 includes a plurality of braided wires, i.e., the above-mentioned plurality of first braided wires 2121, and the other support members may include a plurality of braided wires or only one braided wire.

In this embodiment, at least one second weaving wire 2141 is inserted into the first gap 2123 formed by the first weaving wire 2121, and since the plurality of first weaving wires 2121 in the first support member 212 are woven with each other, so that the position of the first gap 2123 is fixed, the second weaving wire 2141 inserted into the first gap 2123 is also fixed at the preset position (the first gap 2123) on the first support member 212, thereby preventing the second weaving wire 2141 inserted into the first gap 2123 from shifting, improving the fixing strength between the first support member 212 and the second support member 214, and facilitating to maintain the relative position relationship between the first support member 212 and the second support member 214 and the configuration of the first support framework 210.

As shown in fig. 2, the first containment disc 21 includes a central region 2101 and a peripheral region 2103, the geometric center of the first containment disc 21 being located within the central region 2101, the peripheral region 2103 being disposed around the edges of the central region 2101 and contiguous with the central region 2101. One end of the plurality of support members is disposed within the middle region 2101 and interconnected; one end of the supports, distal from the central region 2101, is disposed in the peripheral region 2103.

Specifically, the first support member 212 and the second support member 214 are both support rings, which are ring-shaped and surround a mesh. The ends of the first support 212 and the second support 214 away from the peripheral region 2103 (disposed within the central region 2101) are connected to each other, and the ends of the first support 212 and the second support 214 away from the central region 2101 extend into the peripheral region 2103.

After the occluder 20 is implanted, the side of the first occluding disk 21 and the second occluding disk 23 used for clamping tissues is the inner side, and the side of the first occluding disk 21 and the second occluding disk 23 departing from the clamped tissues is the outer side. In this embodiment, the occluder 20 is a patent foramen ovale occluder, the first occluding disk 21 is used for implanting into the left atrium, the second occluding disk 23 is used for implanting into the right atrium, the tightening member 25 connects the first occluding disk 21 and the second occluding disk 23, one side of the first occluding disk 21 and one side of the second occluding disk 23 used for clamping atrial septal tissue are inner sides, one side of the first occluding disk 21 and one side of the second occluding disk 23 departing from the atrial septal tissue are outer sides, and the part of the tightening member 25 located between the first occluding disk 21 and the second occluding disk 23 is used for penetrating into the patent foramen ovale; the spacing between the first closing disk 21 and the second closing disk 23 can be adjusted by actuating the tightening means 25.

As shown in fig. 1, the delivery device of the occlusion system 100 comprises a sheath 30 and a handle 50, wherein the sheath 30 is used for accommodating the occluding device 20 and delivering the occluding device 20 into the vascular system of the human body; a handle 50 is attached to the proximal end of the sheath 30 for the operator to control the delivery of the occluding device 20, the release of the occluding device 20, and the adjustment of the size of the distance between the first occluding disk 21 and the second occluding disk 23 by adjusting the tightening member 25 to accommodate the needs of different patients and different anatomical structures. In this embodiment, the tightening member 25 is a tightening wire, the tightening wire includes an adjusting wire 251 and a locking wire 253, the ends of the adjusting wire 251 and the locking wire 253 penetrate through the sheath 30 to connect to the handle 50, and the handle 50 controls the adjusting wire 251 and the locking wire 253 to realize the functions of adjusting the diameter and locking the occluder 20.

As shown in fig. 1 and fig. 2, in the present embodiment, the supporting members of the first blocking disc 21 and the supporting members of the second blocking disc 23 are supporting rings, and the supporting rings of the first blocking disc 21 and the supporting rings of the second blocking disc 23 respectively enclose a petal-shaped supporting framework. The first closing disk 21 is used as an example for illustration: the plurality of support rings include a first support ring, a second support ring, a third support ring, a fourth support ring, and an … … nth support ring, the first to nth support rings are sequentially arranged in the circumferential direction of the first plugging disc 21, for example, clockwise or counterclockwise, the first support ring is located between the second support ring and the nth support ring, the second support ring is located between the first support ring and the third support ring, and so on. In this embodiment, each support ring is formed by winding and weaving a plurality of weaving wires or arranging the plurality of weaving wires side by side, that is, the first support ring to the nth support ring are formed by winding and weaving a plurality of weaving wires; the braided filaments of each two adjacent support rings at the intersection are interpenetrated.

Specifically, the first supporting framework 210 includes six supporting members, namely, a first supporting member 212, a second supporting member 214, a third supporting member 215, a fourth supporting member 216, a fifth supporting member 217 and a sixth supporting member 218 arranged in time sequence of the first plugging disk 21. The two adjacent supporting members are connected to each other in the peripheral region 2103 in an interpenetration manner, that is, the first supporting member 212 and the second supporting member 214, the second supporting member 214 and the third supporting member 215, the third supporting member 215 and the fourth supporting member 216, the fourth supporting member 216 and the fifth supporting member 217, the fifth supporting member 217 and the sixth supporting member 218, and the sixth supporting member 218 and the first supporting member 212 are connected to each other in the peripheral region 2103 in an interpenetration manner.

The ends of the two adjacent supporting members located in the middle region 2101 are connected to each other in an interlaced manner, that is, the ends of the first supporting member 212 and the third supporting member 215, the ends of the second supporting member 214 and the fourth supporting member 216, the ends of the third supporting member 215 and the fifth supporting member 217, the ends of the fourth supporting member 216 and the sixth supporting member 218, the ends of the fifth supporting member 217 and the first supporting member 212, and the ends of the sixth supporting member 218 and the second supporting member 214 in the middle region 2101 are connected to each other in an interlaced manner.

That is, in the present embodiment, the intersecting positions of the supporting members in the peripheral region 2103 and the central region 2101 of the first blocking disk 21 are both in a relationship of insertion connection.

The first blocking disk 21 is made of a metal material with good biocompatibility, such as nitinol, stainless steel, etc. Because a plurality of support pieces on first shutoff dish 21 arrange along circumference, first shutoff dish 21 only sets up a support ring in footpath promptly, the metal usage rate that adopts this kind of big mesh design to make in the first support skeleton 210 is lower, the risk that metal ion is appeared at the human body has been reduced to a certain extent, big mesh design makes the metal coverage of first shutoff dish 21 reduce in addition, the flexibility improves, quotation porosity is big, make things convenient for the follow-up mesh that passes support piece formation in room interval position of patient to make a mouthful.

Alternatively, at least one of the support rings of the first occluding disk 21 is braided from a plurality of braided filaments and at least one of the support rings of the second occluding disk 23 is braided from a plurality of braided filaments. In this embodiment, each of the first to sixth supports 22 to 22 is formed by winding a plurality of braided wires to form a support ring, specifically, the first support 22 is a first support ring formed by winding a plurality of first braided wires 2121, the second support 214 is a second support ring formed by winding a plurality of second braided wires 2141, the third support 215 is a third support ring formed by winding a plurality of third braided wires 2151, the fourth support 216 is a fourth support ring formed by winding a plurality of braided wires, the fifth support 217 is a fifth support ring formed by winding a plurality of braided wires, and the sixth support 218 is a sixth support ring formed by winding a plurality of braided wires. The second support ring is circumferentially positioned between the first support ring and the third support ring, and at least a portion of the second braided filament 2141 is threaded through the gaps between the plurality of third braided filaments 2151 and the plurality of first braided filaments 2121; alternatively, at least a portion of the third braided filament 2151 is threaded through the interstices formed between the strands of the second braided filament 2141. The two-end braided filaments of each support ring in the first plugging disc 21 are fixed in the middle region 2101. The plugging disc formed by the support ring woven by the plurality of strands of woven wires is softer than the plugging disc formed by cutting, and has certain support performance, so that the plugging device 20 is better attached to tissues.

The plurality of strands of braided wire in each support ring of the first support armature 210 and the second support armature 230 are in a intertwined relationship with each other. In one embodiment, the braided wires in one support ring are mutually juxtaposed and are not intertwined; in another embodiment, a support ring is formed from a single braided wire. Each woven wire is a high-elasticity nickel-titanium alloy wire with a shape memory function, and the diameter of each woven wire is 0.05-3.2 mm, so that the plugging device 20 can quickly rebound after entering a human body through a conveyor to achieve a plugging effect.

Referring to fig. 2 and 3, the plurality of braided wires of each adjacent two support rings of the first support frame 210 are inserted together at the intersection. The meaning of "threaded connection" in the present application is described below by taking as an example that the first support 212 and the second support 214 are threaded and connected with each other at intersection positions in the peripheral region 2103, and it is understood that the technical solution of "threaded connection" can be applied to other intersection positions between adjacent supports in the present embodiment (for example, at intersection positions in the peripheral region 2103, or at intersection positions in the central region 2103).

Specifically, the first support 212 and the second support 214 are inserted into the peripheral region 2103, and the intersecting position may be an intersecting point of overlapping positions of the first support 212 and the second support 214, or an abutting point of two support rings.

As shown in fig. 3, a first gap 2123 is formed between the plurality of first braided filaments 2121 of the first support 212, and the second support 214 or at least a portion of the second braided filament 2141 is inserted into the first gap 2123, so that the first support 212 and the second support 214 are constrained and fixed to each other, thereby avoiding or reducing the use of sewing for fixing the first support 212 and the second support 214. Since the plurality of strands of the first braided wire 2121 in the first support member 212 are braided with each other in this embodiment, so that the position of the first slit 2123 is fixed, the second braided wire 2141 inserted into the first slit 2123 is also fixed at the predetermined position (the first slit 2123) on the first support member 212, thereby preventing the second braided wire 2141 inserted into the first slit 2123 from being displaced, improving the fixing strength between the first support member 212 and the second support member 214, and facilitating to maintain the relative position relationship between the first support member 212 and the second support member 214 and the configuration of the first support framework 210.

In other embodiments, a second gap is formed between the plurality of second braided filaments 2141 of the second support 214, and the first support 212 or at least a portion of the first braided filaments 2121 are inserted in the second gap.

Alternatively, as shown in fig. 2, in the middle region 2101, at least a portion of the first braided filament 2121 passes through the interstices between the strands of the third braided filament 2151; alternatively, in other embodiments, at least a portion of the third braided filament 2151 passes through the interstices between the first braided filaments 2121.

In other embodiments, at least one of the supporting members of the first plugging disk 21 has a mutually penetrating connection, and the connection between the supporting members at other positions may be mutually woven, mutually bonded and fixed, or fixed by a suture. As shown in fig. 2, a first cover film 2100 is disposed on the first blocking disk 21, the first cover film 2100 may cover the outer side and/or the inner side of the first supporting framework 210, and if the first supporting framework 210 is in a cage shape and forms an inner cavity, the first cover film 2100 may also be disposed in the inner cavity of the first supporting framework 210, in this embodiment, the first cover film 2100 covers the outer surface of the first supporting framework 210; in other embodiments, the first cover film 2100 covers at least a portion of the outer side surface of the first support armature 210.

As shown in fig. 1, a second covering film 2300 is disposed on the second blocking disc 23, the second covering film 2300 may cover the outer side and/or the inner side of the second supporting frame 230, and if the second supporting frame 230 is cage-shaped and has an inner cavity, the second covering film 2300 may also be disposed in the inner cavity of the second supporting frame 230. In this embodiment, the second cover film 2300 covers the inner side surface of the second support frame 230; in a modified embodiment, the second cover film 2300 covers at least a part of the inner surface of the second support frame 230.

The first cover film 2100 and the second cover film 2300 are used to prevent blood on the side of the defect from flowing into the defect. In this embodiment, the first cover film 2100 is disposed outside the first support frame 210, and the second cover film 2300 covers the inside of the second support frame 230.

The first cover film 2100 and the second cover film 2300 are made of polyester fabric, PTFE, PET, or another polymer material, the first support frame 210 is sewn to the first cover film 2100 by a sewing thread, and the second support frame 230 is also sewn to the second cover film 2300 by a sewing thread.

In other embodiments, the first cover film 2100 and the second cover film 2300 may be fixed to the first support frame 210 and the second support frame 230 respectively in other manners such as hot pressing or attaching. In the modified embodiment, the first cover film 2100 is omitted from the first closing disk 21, and/or the second cover film 2300 is omitted from the second closing disk 23.

As shown in fig. 4, in the modified embodiment, a third slit 2125 is formed between the plurality of first braided filaments 2121 of the first support member 212 and spaced from the first slit 2123, the second support member 214 includes a first braided filament 2143 and a second braided filament 2145, each of the first braided filament 2143 and the second braided filament 2145 includes at least one second braided filament 2141, the first braided filament 2143 passes through the first slit 2123, and the second braided filament 2145 passes through the third slit 2125. This insertion increases the insertion point between the first support member 212 and the second support member 214, and improves the fixing strength between the first support member 212 and the second support member 214, and the supporting performance of the first blocking disk 21.

In other embodiments, the plurality of second braided wires 2141 forms two gaps therebetween, and the first support 212 includes two braided wires, each of which includes at least one first braided wire 2121, and each of the two braided wires passes through one of the gaps in the second braided wires 2141.

In other embodiments, three or more slits are formed between the plurality of strands of the first braided filaments 2121, the second supporting member 214 includes three or more strands of braided filaments, each strand of braided filament includes at least one strand of the second braided filament 2141, and the three or more strands of braided filaments pass through the three or more slits.

Optionally, as shown in fig. 2, the at least one support ring of the first blocking disk 21 includes two body segments 2104 and a protruding segment 2105 connected between the two body segments 2104, the protruding segment 2105 is disposed at a circumferential end of the first support skeleton 210 and protrudes in a direction radially away from a geometric center of the first support skeleton 210, the body segment 2104 is disposed adjacent to the geometric center of the first support skeleton 210 compared to the protruding segment 2105, and the protruding segment 2105 occupies a smaller circumferential angle on the circumference of the first support skeleton 210 compared to the body segment 2104. Specifically, in the present embodiment, the first support 212 to the sixth support 218 of the first support frame 210 are support rings, each support ring includes a protruding section 2105 and a body section 2104 connected to two opposite sides of the protruding section 2105, and the protruding section 2105 of each support ring is located on the peripheral area 2103 of the first blocking disk 21. Receive the sheath in-process, the bracing piece is in the same place easily in the both sides of protruding section 2105, has reduced first shutoff dish 21 and has received the resistance that the sheath in-process support ring resisted deformation at deformation in-process for it is more smooth and easy laborsaving to receive the sheath.

Preferably, each projecting section 2105 forms a nose; in this embodiment, each projecting section 2105 is an arcuate lobe. In other embodiments, the projecting section 2105 may also be a pointed or other shaped protrusion.

As shown in fig. 1 and 5, the circumferential end of the first supporting frame 210 extends toward the side where the connecting member 25 is located, that is, toward the inner side of the first plugging disc 21. That is, the circumferential end of the first support frame 210 of the first plugging disc 21 extends obliquely to one side of the second plugging disc 23, specifically, the circumferential end of each support ring of the first support frame 210 extends inward of the first plugging disc 21; alternatively, the circumferential end of the second supporting skeleton 230 of the second plugging disc 23 extends obliquely to one side of the first plugging disc 21, i.e. to the inner side of the second plugging disc 23. In this embodiment, the axis of the first support frame 210 passes through the geometric center thereof, and the axis of the second support frame 230 passes through the geometric center thereof.

Preferably, an included angle between a line connecting the geometric center of the first support frame 210 and the circumferential end thereof and the axial direction of the first support frame 210 is a, wherein a is more than 0 and less than 45; in this embodiment, the included angle a is 20 degrees. Correspondingly, the range of the included angle between the connecting line of the geometric center and the circumferential end of the second supporting framework 230 and the axial direction of the second supporting framework 230 is greater than 0 degree and smaller than 45 degrees. The design is used for realizing rapid rebound of the occluder 20 after entering a human body through the conveyor, the edges of the first occluding plate 21 and the second occluding plate 23 are smoothly attached to tissues, and the primary and secondary septa for defect can be conveniently endothelialized towards the two occluding plates.

In other embodiments, as shown in fig. 6, the respective supporting members of the first plugging disk 21a form a planar supporting skeleton, i.e. the respective supporting members of the first plugging disk 21a are located on the same plane; the individual supporting elements of the second plugging disc 23a form a planar supporting skeleton, i.e. the individual supporting elements of the second plugging disc 23a are located in the same plane. The first blocking disk 21a is thus parallel to the second blocking disk 23 a.

Various technical solutions of the first supporting framework 210 and the second supporting framework 230 of the present invention may be applicable to each other, and are not described herein again.

As shown in fig. 1, after the tightening member 25 passes through the geometric center of the first blocking disk 21, an adjustment wire 251 and a locking wire 253 are formed, and the ends of the adjustment wire 251 and the locking wire 253 pass through the middle portion of the second blocking disk 23 and the sheath 30 to be connected to the handle 50. When the adjusting wire 251 is tightened by means of the handle 50, the tightener 25 can pull the first closing disk 21 so that the distance between the first closing disk 21 and the second closing disk 23 is adjusted.

As shown in fig. 2, the first containment disc 21 includes a first sleeve 2106 disposed in a central region thereof, and the tightener 25 is attached to the first sleeve 2106. The end of the support ring on the first support framework 210 distal from the projecting section 2105 is fixedly connected to the first sleeve 2106; preferably, the first sleeve 2106 is disposed at the geometric center of the first plugging disk 21, and the plurality of support rings are connected to the first sleeve 2106 and surround the first sleeve 2106 to form the first support frame 210. The first sleeve 2106 may be a steel sleeve or a steel sleeve assembly made of a metallic material.

Correspondingly, the second closing disk 23 comprises a second sleeve (not shown) arranged in its central region, which is fixedly arranged in the geometric center of the second closing disk 23; the supporting ring of the second plugging disc 23 surrounds the second sleeve to form a second supporting skeleton 230; the second sleeve of the second closing disk 23 is cylindrical and has a cavity through which the end of the adjusting section 251 or the locking section 253 passes. Preferably, the end of the adjusting section 251 passes through the cavity of the second sleeve, and the end of the locking section 253 passes through the mesh formed by the second support frame 230 around the second sleeve. The second sleeve may be a steel sleeve or a steel sleeve assembly made of a metallic material.

Preferably, the geometric center of the first steel sleeve 2106 is provided with a coil through which the tightening wire 25 is passed and tightened, and the intersection of the coil and the tightening wire is located on the geometric center of the first plugging disk 21, so that the first plugging disk 21 is uniformly pulled.

Preferably, the first steel shroud 2106 has two oppositely disposed openings, and a cavity between the two openings; the coil is suspended from the steel shroud 2106 through both the openings and the cavity. Optionally, the ends of several support rings are attached to the outer perimeter of first steel sleeve 2106 and are fixedly attached to first steel sleeve 2106 by welding or bonding. The first steel sleeve 2106 is made of stainless steel, nitinol or other biocompatible materials.

Optionally, the disc surfaces of the first blocking disc 21 and the second blocking disc 23 may be set to be circular, polygonal, elliptical, triangular or other irregular shapes, and the radial area of the first blocking disc 21 and the radial area of the second blocking disc 23 may be the same or different. In the present embodiment, the first blocking disk 21 and the second blocking disk 23 are both in the shape of a substantially hexagonal disk, and the radial area of the first blocking disk 21 is equal to the radial area of the second blocking disk 23. In one embodiment, the area of the first plugging disc 21 is smaller than the area of the second plugging disc 23.

The first and

second cover films

2100 and 2300 may be flow-blocking films, and may be non-degradable polymer material films with good biocompatibility, such as ePTFE or PET materials; the first cover film 2100 and the second cover film 2300 may also be made of absorbable polymer material such as polylactic acid, polycaprolactone, polylactic acid-caprolactone copolymer, etc. The first cover film 2100 and the second cover film 2300 are fixed to the inner surface or the outer surface of the blocking disk by sewing, heat sealing, or gluing, and the like, and are used for blocking blood flow.

The support rings of the first and second support frames 210, 230 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 scaffold 210 and the second support scaffold 230 can 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 frame 210 and the second supporting frame 230 may also be made of high molecular polymer materials.

In use, the first occluding disk 21 is delivered by sheath 30 to and deployed in the left atrium, and the second occluding disk 23 is delivered by sheath 30 to and deployed in the right atrium. The tightening wire connected between the first plugging disc 21 and the second plugging disc 23 is flexible and adjustable in length, and penetrates through the oval hole between the primary diaphragm and the secondary diaphragm; the adjusting section 251 is pulled towards the near end, the tightening wire is tensioned, and the tightening wire is gradually shortened, namely, the distance between the first blocking disc 21 and the second blocking disc 23 is gradually reduced, the primary diaphragm and the secondary diaphragm are close to each other and are clamped by the first blocking disc 21 and the second blocking disc 23, the primary diaphragm and the secondary diaphragm are covered around the foramen ovale by the first blocking disc 21, and the primary diaphragm and the secondary diaphragm are covered around the foramen ovale by the second blocking disc 23, namely, openings at two sides of the foramen ovale in the left atrium and the right atrium are respectively covered by the first blocking disc 21 and the second blocking disc 23. Because first shutoff dish 21 and second shutoff dish 23 all include the support chassis and set up the stop flow membrane on the support chassis, the cover membrane of oval hole both sides can prevent blood inflow the oval hole to avoided the blood flow to flow into the right atrium from the left atrium, in order to realize instant shutoff. After the occluder 20 is implanted into a human body, the primary diaphragm and the secondary diaphragm crawl to the contact positions of the first occluding disk 21 and the second occluding disk 23 so as to close the oval hole after the endothelialization is completed, and a complete atrial septum is formed. Because the support rings of the first support frame 210 are woven integrally by mutually inserting or winding a plurality of strands of woven wires, and the support rings of the second support frame 230 are woven integrally by mutually inserting or winding a plurality of strands of woven wires, the structures of the first support frame 210 and the second support frame 230 are more stable and firm. In a modified embodiment, the density of the supporting frameworks on the two plugging discs is high enough, and the covering film is omitted, so that the endothelialization of the two diaphragms to the plugging discs is not influenced, and the shunting on the oval hole channel is not formed or is small.

Referring to fig. 7, fig. 7 is a schematic view of another connection mode of a plurality of support rings of the plugging system of the present invention, the another connection mode of the plurality of support rings is similar to the structure of the first plugging disk 21 in one embodiment, except that: the first support ring 212 and the third support ring 215 include a joint section 2108 joined together; first support ring 212 further includes a separator section 2127 connected to coupling section 2108, and third support ring 215 further includes a separator section 2157 connected to coupling section 2108; the joining section 2108 is closer to the geometric center of the first plugging disk 21b than the separating

sections

2127, 2157. At least a portion of the bonded section 2018 is located in the central region 2101 and at least a portion of the

separate sections

2127, 2157 are located in the peripheral region 2103.

As shown in fig. 7, the connecting sections 2108 are integrally connected to each other in the same extending direction, in the present embodiment, the plurality of first braided wires 2121 and the plurality of third braided wires 2151 in the connecting sections 2108 are integrally braided, and in the modified embodiment, the plurality of first braided wires 2121 and the plurality of third braided wires 2151 in the connecting sections 2108 are fixedly connected to each other by bonding, thread winding, knotting, welding, or the like.

In this embodiment, the first support 212 and the third support 215 located in the

separate sections

2127, 2157 extend in different directions, and the plurality of first braided filaments 2121 and the plurality of third braided filaments 2151 located in the

separate sections

2127, 2157 are separated from each other. As shown in the first embodiment, in the peripheral area 2103, the separated sections (e.g., the separated sections 2127, 2157) of the adjacent supports extend in different directions, and the intersecting positions between the separated sections are in an inserting connection relationship, for example, the second support 214 includes a separated section 2147 which is away from the geometric center of the first blocking disk 21b and is at least partially located in the peripheral area 2103, and the separated section 2127 of the first support and the separated section 2147 of the second support 214 extend in different directions and are fixed to each other in the peripheral area 2103 by the above-mentioned inserting connection manner.

Specifically, in this embodiment, in the middle region 2101 near the geometric center of the plugging disc 21b, the ends of two adjacent support rings are of integrally woven structure; as the first support 212 is integrally wrapped with the braided filaments of the third support 215 at the end of the occluding disk central region 2101, the first support 212 intersects the combined section 2108 of the third support 215 and the first plurality of braided filaments 2121 at the intersection is integrally wrapped with the third plurality of braided filaments 2151. In the peripheral region 2103, two adjacent support rings are inserted and connected, that is, in the peripheral region 2103, the second support 214 is located between the first support 212 and the third support 215, and the second support 214 is inserted and connected with the first support 212 and the third support 215. Referring to fig. 8, fig. 8 is a schematic view of another structure of the supporting framework 210a of the occlusion system of the present invention, the structure of the supporting framework 210a is similar to that of the first supporting framework 210 in one of the above embodiments, except that: the support frame 210a only includes three support rings, each support ring is formed by winding and weaving multiple strands of weaving wires or arranging the support rings side by side, the three support rings are arranged along the circumferential direction of the support frame 210a, and each support ring is connected with two adjacent support rings in an inserting manner. The supporting framework 210a is only provided with three supporting rings, the metal coverage rate is low, the porosity of the disc surface is high, the patient can conveniently make a stoma through meshes formed by the supporting pieces at the atrial septum position subsequently, and in addition, the risk of heavy metal ion precipitation is reduced due to low metal content. In the present embodiment, the supporting frame 210a is provided with an intersecting position between three supporting members in the peripheral region, the intersecting position is connected in an inserting manner, and the supporting frame 210a does not include the intersecting position between the supporting members in the central region.

Referring to fig. 9, fig. 9 is a schematic view of another structure of the supporting framework 210b of the occlusion system of the present invention, the structure of the supporting framework 210b is similar to that of the first supporting framework 210 in one of the above embodiments, except that: the support framework 210b comprises four support rings, the four support rings are uniformly arranged along the circumferential direction of the support framework 210b to form two pairs of support rings which are vertical to each other, wherein one pair of support rings arranged at intervals are formed by winding and weaving multiple strands of weaving wires or are arranged side by side, and the other pair of support rings arranged at intervals are formed by surrounding one support rod; the support ring surrounded by the support rods is inserted in the support rods formed by winding a plurality of strands of braided wires.

Referring to fig. 10, fig. 10 is a schematic view of another structure of the plugging disk 21c of the plugging system of the present invention, the structure of the plugging disk 21c is similar to that of the first plugging disk 21 in one embodiment, except that: the plugging disc 21c is triangular, the supporting framework of the plugging disc 21c only comprises three supporting rings, the three supporting rings are arranged along the circumferential direction of the plugging disc 21c, the end parts of every two adjacent supporting rings, which are adjacent to the geometric center, are tangent, the three supporting rings in the plugging disc 21c are respectively a first supporting ring, a second supporting ring and a third supporting ring, the middle area of the plugging disc 21c, which is close to the first sleeve, is provided with 3 combining sections, the first supporting ring and the second supporting ring are combined and integrated in a combining section, the first supporting ring and the third supporting ring are combined and integrated in a combining section, the second supporting ring and the third supporting ring are combined and integrated in a combining section, and the combining sections of the adjacent supporting rings in the middle area can be woven with each other, the connection is made by means of stitching, gluing or welding so that adjacent support bars in the joint extend in the same direction.

Referring to fig. 11 to 14, the supporting framework of the plugging disc 21d in fig. 11 is formed by 8 supporting rings arranged along the circumferential direction of the plugging disc 21 d; the supporting skeleton of the plugging disc 21e in fig. 12 is formed by arranging 12 supporting rings along the circumferential direction of the plugging disc 21 e; the supporting framework of the plugging disc 21f in fig. 13 is formed by 18 supporting rings arranged along the circumferential direction of the plugging disc 21 f; the supporting skeleton of the plugging disc 21g in fig. 14 is formed by 24 supporting rings arranged in the circumferential direction of the plugging disc 21 g; the more the support rings of support skeleton are, the intersection point on every support ring is just more, and the quotation shaping back metal coverage is higher, and support skeleton's support intensity is just higher, makes the plugging device get into human back support effect just better.

Referring to fig. 15, fig. 15 is a schematic view of another structure of the plugging disk of the plugging system of the present invention, and the structure of the plugging disk 21h is similar to that of the first plugging disk 21 in one of the above embodiments, except that: the shape of the support ring of the blocking disc 21h is changed, i.e. the support ring of the blocking disc 21h is a relatively narrow ellipse in the circumferential direction, and the knitting manner of the support ring of the blocking disc 21h is the same as the knitting manner of the first support frame 210 of the first blocking disc 21, which is not described herein again.

The foregoing is an implementation manner of the embodiments of the present invention, and it should be noted that specific technical solutions in the foregoing embodiments may be mutually applicable, and for those skilled in the art, several improvements and modifications may be made without departing from the principle of the embodiments of the present invention, and these improvements and modifications are also considered as the protection scope of the present invention.

Claims

1. An occluder for occluding a defect in a vasculature, wherein the occluder comprises a first occlusion disc and a second occlusion disc that are connected to each other, the first occluder The disk includes a first support frame, and the first support frame includes a plurality of support members arranged along the circumferential direction of the first blocking disk; the plurality of support members include a first support member and a second support member arranged adjacent to each other , the first support member includes a plurality of first braided wires, the second support member includes at least one second braided wire, and at least some of the second braided wires in the second support member are interspersed with the plurality of second braided wires in the first gap formed between the first braided wires.

2 . The occluder according to claim 1 , wherein the first support member is a first support ring formed by surrounding the plurality of first braided wires, and the second support member is a plurality of first support rings. 3 . The second support ring formed by the two braided filaments surrounds.

3 . The occluder according to claim 2 , wherein a second gap is formed between the plurality of second braided wires, and at least part of the first braided wires are inserted into the second gap. 4 .

4 . The occluder according to claim 2 , wherein a third gap spaced from the first gap is further formed between the plurality of first braided wires, and the second support ring comprises a first gap. 5 . A bundle of braided filaments and a second bundle of braided filaments, each of the first bundle of braided filaments and the second bundle of braided filaments includes at least one second braided filament, and the first braided filament passes through the first a slit, and the second braided wire passes through the third slit.

5 . The occluder according to claim 2 , wherein the plurality of support members further comprise a third support ring surrounded by a plurality of third braided wires, and the second support ring is located in the circumferential direction. 6 . Between the first support ring and the third support ring, at least part of the second braiding wire passes through the gap between the plurality of third braiding wires; or, at least part of the third braiding wire is formed between the plurality of second braiding wires through the gap.

6 . The occluder according to claim 5 , wherein at least part of the first braided wire passes through the gap between the plurality of third braided wires; or, at least part of the third braided wire passes through the The gap between the first braided wires; or, the first support ring and the third support ring both include a combination section and a separation section, and the combination section is distant from the first plugging disc relative to the separation section are closer to the geometric center, the plurality of first braided wires and the plurality of third braided wires located in the combined section are combined together, and the plurality of first braided wires and the plurality of third braided wires located in the separation section are combined together. separated from each other.

7 . The occluder of claim 6 , wherein the second support ring comprises a coupling segment and a separation segment, and the coupling segment is spaced relative to the geometry of the separation segment from the first occlusion disc. 8 . The center is relatively close, and the multiple first braided wires and the multiple second braided wires located in the combined section are combined together, and the multiple first braided wires and the multiple second braided wires located in the separation section are separated from each other .

8 . The occluder according to claim 6 or 7 , characterized in that, the plurality of first braided wires and other braided wires in the combined section are braided and fixed to each other, or fixed by suturing. 9 .

9 . The occluder according to claim 1 , wherein the plurality of support members are a plurality of support rings, wherein at least one support ring comprises two body segments and a protruding segment connected between the two body segments. 10 . , the protruding section is arranged at the circumferential end of the first support frame, and protrudes radially away from the geometric center of the first support frame, and the body section is relatively distant from the protruding section The geometric center of the first support frame is closer, and the protruding section occupies a smaller circumferential angle on the circumference of the first support frame than the body section.

10. The occluder according to claim 9, wherein the protruding section forms a convex tip.

11. The occluder according to claim 1, characterized in that, the occluder further comprises a connecting piece, and the connecting piece is connected between the first occluding disc and the second occluding disc , the distance between the first blocking disc and the second blocking disc can be changed by adjusting the connecting piece.

12 . The occluder according to claim 11 , wherein after the occluder is implanted, the side of the first occlusion disc used to clamp the tissue is the inner side, and the first support skeleton The circumferential end of the ' extends towards the inside of the first occluding disc.

13 . The occluder according to claim 12 , wherein the angle between the line connecting the geometric center of the first support frame and its circumferential end and the axial direction of the first support frame is 13 . a, where 0°<a<45°.

14. The occluder according to claim 11, wherein the first occlusion disc comprises a first covering film disposed on the first support frame, and the second occlusion disc comprises a second covering film A support frame and a second cover film arranged on the second support frame.

15 . The occluder according to claim 14 , wherein after the occluder is implanted, the side of the first occlusion disc and the second occlusion disc used to clamp tissue is 15 . The inner side, the side of the first occlusion disc and the second occlusion disc facing away from the clamped tissue is the outer side, and the first covering film is arranged on the outer surface of the first support frame; and/or all The second cover film is disposed on the inner surface of the second support frame.

16. An occlusion system comprising the occluder of any one of claims 1 to 15, the system further comprising a conveyor for releasing the occluder.