WO2022002087A1

WO2022002087A1 - Occluder and occluding system

Info

Publication number: WO2022002087A1
Application number: PCT/CN2021/103312
Authority: WO
Inventors: 陈杰; 赵江浪; 程晓阳; 王永胜
Original assignee: 杭州德诺电生理医疗科技有限公司
Priority date: 2020-07-01
Filing date: 2021-06-29
Publication date: 2022-01-06

Abstract

An occluder (20) for occluding defects in a vasculature. The occluder (20) comprises a first occluding member (21), wherein the first occluding member (21) comprises a first support structure (210). The first support structure (210) comprises a plurality of support members arranged in the circumferential direction of the first occluding member (21), wherein the plurality of support members comprise a first support member (212) and a second support member (214) which are arranged adjacently. The first support member (212) comprises a plurality of strands of first weaving filaments (2121), and the second support member (214) comprises at least one strand of second weaving filaments (2141), with at least some of the second weaving filaments (2141) in the second support member (214) being inserted into first gaps (2123) formed between the plurality of strands of first weaving filaments (2121), so as to interweave and connect the first support member (212) and the second support member (214) into a whole, in order to reduce or avoid the situation where a suture line is used for fixing the first support member (212) and the second support member (214), such that the first support member (212) is connected to the second support member (214) more firmly, thereby improving the reliability and safety of the occluder (20).

Description

Occluder and Occlusion System

technical field

The present application relates to the field of medical devices, and in particular, to an occluder and an occlusion system for sealing defects in a human body.

Background technique

The foramen ovale is a physiological channel through which the blood of the umbilical vein flows from the right atrium to the left atrium in the atrial septum to maintain fetal blood circulation. After birth, the valve of the foramen ovale closes automatically with the formation of the pulmonary circulation. About 25% of babies are born after birth. Fibrin attachment and permanent closure occurs around 1 year of age, and if the potential interatrial passage remains after 3 years of age, it is called patent foramen ovale (PFO).

Patent foramen ovale refers to the failure of natural adhesion and fusion of the primary diaphragm and the secondary diaphragm after birth, and there is a cleft-like abnormal communication of about 7 mm in length and 1 to 6 mm in width between the two, which is similar to a functional valve. When the right atrial pressure is higher than the left atrial pressure, the weak primary septum on the left side is pushed open, that is, a right-to-left shunt occurs. Among the various common right-to-left congenital heart diseases, patent foramen ovale is the most common. In recent years, the relationship between patent foramen ovale and unexplained ischemic stroke, decompression sickness, migraine, etc. has been paid more and more attention, and it is considered to be a new cause of ischemic cerebral infarction, especially in young people. risk factors. For patients with indicated patent foramen ovale, interventional therapy has gradually replaced surgery and drug therapy as the first choice for clinical treatment. Studies have confirmed that percutaneous closure of patent foramen ovale is a safe and effective treatment with low complications and good clinical follow-up results.

At present, the commercialized non-degradable occluders that have appeared at home and abroad are mainly occluders based on metal alloy materials and non-degradable polymer fabrics. However, the fixation at the connection point of this kind of alloy occluder is mostly fixed by suture with the membrane at a later stage, and there is a risk of wear and loss at the connection point of this fixation method.

SUMMARY OF THE INVENTION

The present application provides an occluder for occluding a defect in a vasculature, the occluder comprising a first occluder, the first occluder comprising a first support frame, the first occluder The support frame includes a plurality of support members arranged along the circumferential direction of the first blocking member; the plurality of support members include a first support member and a second support member arranged adjacently, and the first support member includes a plurality of first support members. a braided wire, the second support member includes at least one second braided wire, and at least a part of the second braided wire in the second support member is inserted into the first gap formed between the plurality of first braided wires middle.

The present application also provides an occlusion system, including an occluder and a conveyor, the occluder comprising a first occluder and a second occluder that are connected to each other, and the first occluder includes a first support A frame, the first support frame includes a plurality of support members arranged along the circumferential direction of the first blocking member; the plurality of support members include a first support member and a second support member arranged adjacently, the first support member The support member includes a plurality of first braided wires, the second support member includes at least one second braided wire, and at least part of the second braided wires in the second support member are interspersed between the plurality of first braided wires. In the first gap formed between, the conveyor is used to release the occluder.

Several supports of the occlusion system provided by the present application include a first support and a second support that are arranged adjacently, the first support includes a plurality of first braided wires, and the second support includes at least one strands of second braided wires, at least part of the second braided wires in the second support member are inserted into the first gaps formed between the plurality of first braided wires, so that the first support member and the The second supports are interpenetrating and connected to each other, so as to reduce or avoid using sutures to fix the first support and the second support, so that the difference between the first support and the second support The connection is firmer, and the reliability and safety of the occluder are improved.

Description of drawings

In order to explain the technical solutions of the embodiments of the present application more clearly, the following briefly introduces the accompanying drawings that need to be used in the implementation manner. As far as technical personnel are concerned, other drawings can also be obtained based on these drawings without any creative effort.

FIG. 1 is a schematic three-dimensional structural diagram of the blocking system provided by one of the embodiments of the present application when it is released.

FIG. 2 is an enlarged view of the inside of the first occlusion member of the occlusion system of FIG. 1 .

FIG. 3 is a schematic structural diagram of one of the connection modes 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 the first support frame in the first occlusion member of the occlusion system of FIG. 1 .

FIG. 6 is a schematic three-dimensional structural diagram of an occluder of an occlusion system provided by another embodiment of the present application.

FIG. 7 is a schematic structural diagram of another connection mode of several support rings of the plugging system of the present application.

FIG. 8 is a schematic diagram of another structure of the support frame of the occlusion system of the present application.

FIG. 9 is a schematic diagram of another structure of the support frame of the occlusion system of the present application.

FIG. 10 is a schematic diagram of another structure of the occlusion disk of the occlusion system of the present application.

FIG. 11 is a schematic diagram of another structure of the occlusion disk of the occlusion system of the present application.

FIG. 12 is a schematic diagram of another structure of the occlusion disk of the occlusion system of the present application.

FIG. 13 is a schematic diagram of another structure of the occlusion disc of the occlusion system of the present application.

FIG. 14 is a schematic diagram of another structure of the occlusion disc of the occlusion system of the present application.

FIG. 15 is a schematic diagram of another structure of the occlusion disc of the occlusion system of the present application.

detailed description

The technical solutions in the embodiments of the present application will be clearly and completely described below with reference to the drawings in the embodiments of the present application. Obviously, the described embodiments are only a part of the embodiments of the present application, but not all of the embodiments. Based on the embodiments in this application, all other embodiments obtained by those of ordinary skill in the art under the premise of not paying creative efforts shall fall within the scope of protection of this application.

In the description of the present application, the "proximal end" of the present application refers to the end that is close to the operator's control, and the "distal end" refers to the end that is far away from the operator's control. The axial direction refers to the direction in which the central axis of the device is located, and the radial direction is the direction perpendicular to the central axis. This definition is only for the convenience of expression and should not be construed as a limitation on the present application.

Please refer to FIG. 1 and FIG. 2 , the present application provides an occlusion system 100, which includes an occluder 20 and a delivery device for releasing the occluder 20. The occluder 20 is used to occlude the vascular system. Defects, the defects include but are not limited to foramen ovale, ductus arteriosus, atrial septal defect, ventricular septal defect, etc. In this application, the defect is the foramen ovale as an example to illustrate that the occlusion system 100 is used for the treatment of the foramen ovale For the advantage of patent, it can be understood that the defect can also be other defects mentioned above.

The occluder 20 includes a first occluder 21 , a second occluder 23 and a tightening piece 25 , the first occluder 21 and the second occluder 23 are respectively used to cover different openings of the defect in the vasculature . The first blocking member 21 can be, but is not limited to, a blocking disk, a blocking plug (extending a certain size in the axial direction to form a column shape), etc. The first blocking member 21 can be a circular structure, an oval structure or Polygonal structure, etc.; the second blocking member 23 may be, but not limited to, a blocking disk, a blocking plug, etc., and the second blocking member 23 may be a circular structure, an elliptical structure, a polygonal structure, and the like. The first blocking member 21 includes a first supporting frame 210 , the second blocking member 23 includes a second supporting frame 230 , and the first supporting frame 210 includes a plurality of supporting members arranged along the circumferential direction of the first blocking member 21 . The second supporting frame The skeleton 230 includes several support members arranged along the circumferential direction of the second blocking member 23 . In this embodiment, the first blocking member 21 and the second blocking member 23 are both blocking discs, that is, the first blocking member 21 and the second blocking member 23 are both disc-shaped, that is, the blocking member 21 The dimension of the second blocking member 23 in the axial direction is much smaller than the dimension in the radial direction, and can be in the shape of a disc or an elliptical disc. In this embodiment, the first blocking member 21 and the second blocking member 23 are both in the shape of a single-layer mesh disk. In the modified embodiment, the first blocking member 21 and/or the second blocking member 23 are double-layered. Layer mesh disk. In some embodiments, the structures of the first blocking member 21 and the second blocking member 23 are different, for example, one of the first blocking member 21 and the second blocking member 23 is disc-shaped and the other is plug-shaped, or One is in the shape of a single-layer mesh disk, the other is in the shape of a multi-layer mesh disk, or neither the first blocking member 21 nor the second blocking member 23 is covered with a film, or at least one is covered with a film. A plurality of the support members on the first blocking member 21 are arranged in an annular array along the geometric center of the first support frame 210 ; a plurality of the support members on the second blocking member 23 are annularly arranged along the geometric center of the second support frame 230 . Array arrangement.

Optionally, in some embodiments, there is only one first blocking member 21 in the occluder 20, and the provision of the second blocking member 23 is omitted, that is, the second blocking member 23 is not provided, and the first blocking member 21 is Single-layer mesh disk shape, multi-layer mesh disk shape, plug shape or other shapes.

In this embodiment, a plurality of the support members include a first support member 212 and a second support member 214 that are arranged adjacent to each other, the first support member 212 includes a plurality of first braided wires 2121, and the second support member 214 includes at least one A second braided wire 2141 is provided, and at least a part of the second braided wire 2141 in the second support member 214 is inserted into the first gap 2123 formed between the plurality of first braided wires 2121, so that the first support member 212 and the second braided wire 2121 are connected to each other. The supports 214 are interpenetrating and connected to each other, and play the role of mutual restraint and fixation, so as to reduce or avoid using sutures to fix the first support 212 and the second support 214, so that the first support 212 and the second support The connection of the piece 214 is firmer, which improves the reliability and safety of the occluder 20 .

In the present application, among the plurality of support members in the first blocking member 21, at least the first support member 212 includes a plurality of braided wires, that is, the upper

In this embodiment, at least one second braided wire 2141 is inserted into the first slit 2123 formed by the first braided wire 2121. Since the multiple first braided wires 2121 in the first support member 212 are woven with each other, the first The position of a slit 2123 is fixed, and the second braided wire 2141 inserted in the first slit 2123 is also fixed at a preset position (the first slit 2123 ) on the first support member 212, so as to avoid being inserted into the first slit 2123. The displacement of the second braided wire 2141 in the gap 2123 improves the fixing strength between the first support member 212 and the second support member 214 and is beneficial to maintain the relative positional relationship between the first support member 212 and the second support member 214 and the configuration of the first support frame 210 .

As shown in FIG. 2 , the first blocking member 21 includes a central area 2101 and a peripheral area 2103 , the geometric center of the first blocking member 21 is located in the central area 2101 , and the peripheral area 2103 is surrounded by the edge of the central area 2101 and is connected to the central area 2101 . Regions 2101 are connected. One end of the plurality of supports is disposed in the middle region 2101 and connected to each other; one end of the plurality of supports far from the middle 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 annular and enclose mesh holes. One ends of the first support member 212 and the second support member 214 away from the peripheral area 2103 (disposed in the central area 2101 ) are connected to each other, and the ends of the first support member 212 and the second support member 214 away from the central area 2101 extend to the peripheral area 2103 Inside.

After the occluder 20 is implanted, the side of the first occluder 21 and the second occluder 23 for clamping the tissue is the inside, and the first occluder 21 and the second occluder 23 are away from the clamped tissue side is the outside. In this embodiment, the occluder 20 is a patent foramen ovale occluder, the first occluder 21 is used to implant into the left atrium, the second occluder 23 is used to implant into the right atrium, The tightening member 25 connects the first blocking member 21 and the second blocking member 23. The side of the first blocking member 21 and the second blocking member 23 for clamping the atrial septal tissue is the inner side, and the first blocking member 21 The side of the second blocking member 23 facing away from the atrial septal tissue is the outer side, and the part of the tightening member 25 located between the first blocking member 21 and the second blocking member 23 is used to pass through the foramen ovale; The operation of the tightening member 25 can adjust the interval between the first blocking member 21 and the second blocking member 23 .

As shown in FIG. 1 , the delivery device of the occlusion system 100 includes a sheath tube 30 and a handle 50. The sheath tube 30 is used to accommodate the occluder 20 and transport the occluder 20 into the vasculature of the human body; the handle 50 is connected to The proximal end of the sheath 30 is used by the operator to control the delivery of the occluder 20, the release of the occluder 20, and the adjustment between the first occluder 21 and the second occluder 23 by adjusting the tightening member 25 The size of the distance to adapt to the needs of different patients and different tissue anatomy. In this embodiment, the tightening member 25 is a tightening wire, and 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 pass through the sheath tube 30 to connect to the handle 50, and the handle 50 By controlling the adjustment wire 251 and the locking wire 253, the waist adjustment of the occluder 20 (adjusting the distance between the first blocking member 21 and the second blocking member 23) and locking (locking the tightening member 25) , so as to fix the function of adjusting the distance between the first blocking member 21 and the second blocking member 23).

As shown in FIG. 1 and FIG. 2 , in this embodiment, several support members of the first blocking member 21 and several support members of the second blocking member 23 are support rings, and several support rings of the first blocking member 21 and a plurality of supporting rings of the second blocking member 23 to form a petal-shaped supporting frame respectively. Taking the first blocking member 21 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, ... Nth support ring, the first support ring to The Nth support ring is arranged in sequence in the circumferential direction of the first blocking member 21, such as clockwise or counterclockwise, the first support ring is located between the second support ring and the Nth support ring, and the second support ring is located at Between the first support ring and the third support ring, and so on. In this embodiment, each support ring is formed by winding and knitting multiple strands of braided wires or arranged side by side, that is, the first support ring to the Nth support ring are all formed by winding multiple strands of braided wires; The braided wires at the intersection of the two support rings are interspersed with each other.

In some embodiments, the supporting member of the first blocking member 21 and the supporting member of the second blocking member 23 may also be supporting rings with openings. Specifically, the open support ring may be, but not limited to, a circular ring with an opening, an oval ring, a rectangular ring, a polygonal ring, and the like.

Specifically, the first support frame 210 includes six supports, that is, the six supports include a first support 212 , a second support 214 , and a third support arranged in chronological order of the first blocking member 21 . 215 , the fourth support 216 , the fifth support 217 and the sixth support 218 . Each adjacent two support members are interpenetratingly connected to each other in the peripheral region 2103 , that is, the first support member 212 and the second support member 214 , the second support member 214 and the third support member 215 , and the third support member 215 and the third support member 215 . The four support members 216 , the fourth support member 216 and the fifth support member 217 , the fifth support member 217 and the sixth support member 218 , and the sixth support member 218 and the first support member 212 are interpenetratingly connected to each other in the peripheral area 2103 .

The ends located in the middle region 2101 of every two adjacent support members are interpenetratingly connected to each other, that is, the first support member 212 and the third support member 215 , the second support member 214 and the fourth support member 216 , and the third support member 215 with the fifth support 217, the fourth support 216 and the sixth support 218, the fifth support 217 and the first support 212, and the ends of the sixth support 218 and the second support 214 in the middle area 2101 The parts are interspersed with each other.

That is, in this embodiment, the intersecting positions of the support members located in the peripheral region 2103 and the middle region 2101 on the first blocking member 21 are in a relationship of interpenetration connection.

The first blocking member 21 is made of a metal material with good biocompatibility, such as nickel-titanium alloy, stainless steel and other materials. Since the plurality of support members on the first blocking member 21 are arranged in the circumferential direction, that is, each support member is provided with only one support ring in the radial direction, the use of this large mesh design enables the metal in the first support frame 210 to use The rate is lower, which reduces the risk of metal ions precipitation in the human body to a certain extent. In addition, the large mesh design reduces the metal coverage of the first blocking member 21, improves flexibility, and has a large disc surface porosity, which is convenient for patients to follow the atrial septum. The stoma is made through the mesh formed by the support.

Optionally, at least one support ring among the plurality of support rings of the first blocking member 21 is woven from a plurality of braided wires, and at least one support ring among the plurality of support rings of the second blocking member 23 is formed of a plurality of braided wires. woven. In this embodiment, the first support member 212 to the sixth support member 218 are each a support ring formed by a plurality of braided wires. Specifically, the first support member 212 is a first support ring formed by a plurality of first braided wires 2121 around. , the second support 214 is a second support ring formed by a plurality of second braided wires 2141, the third support 215 is a third support ring formed by a plurality of third braided wires 2151, and the fourth support 216 is a plurality of The fourth support ring formed by the surrounding braided wires, the fifth support member 217 is the fifth support ring formed by the surrounding multiple braided wires, and the sixth support member 218 is the sixth support ring formed by the surrounding multiple braided wires. The second support ring is located between the first support ring and the third support ring in the circumferential direction, and at least part of the second braided wires 2141 pass through the gaps between the plurality of third braided wires 2151 and the plurality of first braided wires 2121 through the gap; or, at least part of the third braided wire 2151 is passed through the gap formed between the plurality of second braided wires 2141 . The braided wires at both ends of each support ring in the first sealing member 21 are fixed in the middle region 2101 . The occlusion disc composed of the support ring woven from multiple braided filaments is softer than the cut occlusion disc, and has certain supporting performance, so that the occluder 20 is better attached to the tissue.

The braided wires in each of the support rings in the first support frame 210 and the second support frame 230 are intertwined with each other. In one of the embodiments, the braided wires in a support ring are juxtaposed with each other, and are not intertwined; in another embodiment, a support ring is composed of one braided wire. Each braided wire is a highly elastic nickel-titanium alloy wire with shape memory function, and the diameter of each braided wire is 0.05-3.2 mm, so that the occluder 20 can quickly rebound after entering the human body through the conveyor to achieve the occlusion effect.

Please refer to FIG. 2 and FIG. 3 together, the multiple braided wires of each of the two adjacent support rings of the first support frame 210 are interspersed together at the intersection. The following is an example of the interpenetration connection between the first support member 212 and the second support member 214 at the intersecting position in the peripheral area 2103 to illustrate the meaning of the “interpenetration connection” in this application. It can be understood that the “interpenetration connection” means The technical solution can be applied to other intersection positions between adjacent support members in this embodiment (eg, at the intersection position in the peripheral area 2103 or at the intersection position in the central area 2103 ).

Specifically, the first support member 212 and the second support member 214 are interpenetratingly connected to each other in the peripheral area 2103, and the intersecting position may be the intersection of the overlapping position of the first support member 212 and the second support member 214, or the intersection of the two positions. abutment point of a support ring.

As shown in FIG. 3 , a first gap 2123 is formed between the plurality of first braided wires 2121 of the first support member 212 , and the second support member 214 or at least a part of the second braided wires 2141 are inserted into the first gap 2123 , so that the The first support member 212 and the second support member 214 are constrained and fixed to each other, which can avoid or reduce the use of sewing to fix the first support member 212 and the second support member 214 . In this embodiment, since the plurality of first braided wires 2121 in the first support member 212 are woven with each other, the position of the first slit 2123 is fixed, and the second braided wires 2141 inserted in the first slit 2123 It is also fixed at the preset position (the first slit 2123 ) on the first support member 212 to avoid the displacement of the second braided wire 2141 inserted in the first slit 2123 , thereby improving the relationship between the first support member 212 and the second braided wire 2141 . The fixing strength between the two support members 214 is beneficial to maintain the relative positional relationship between the first support member 212 and the second support member 214 and the configuration of the first support frame 210 .

In other embodiments, a second gap is formed between the plurality of second braided wires 2141 of the second support member 214 , and the first support member 212 or at least a part of the first braided wires 2121 are inserted through the second gap.

Optionally, as shown in FIG. 2 , in the middle region 2101 , the first support member 212 and the third support member 215 are interpenetratingly connected to each other; specifically, at least part of the first braiding wire 2121 passes through multiple third braiding wires 2151 or, in other embodiments, at least part of the third braided wires 2151 passes through the gaps between the first braided wires 2121 .

In other embodiments, there is at least one interpenetrating connection between the support members in the first blocking member 21, and the connection relationship between the support members at other positions may be woven with each other, or bonded and fixed to each other, or It is fixed with sutures. As shown in FIG. 2 , the first blocking member 21 is provided with a first covering film 2100 , and the first covering film 2100 may cover the outer side and/or the inner side of the first support frame 210 . If it is cage-shaped and has an inner cavity, the first covering film 2100 can also be arranged in the inner cavity or the outer surface of the first supporting frame 210. In this embodiment, the first covering film 2100 covers the outer surface of the first supporting frame 210. In order to facilitate the connection of the distal end of the tightening member 25 to the first support frame 210, it is beneficial to maintain the integrity of the first cover film 2100; in other embodiments, the first cover film 2100 covers at least part of the outer surface of the first support frame 210 .

As shown in FIG. 1 , a second covering film 2300 is disposed on the second blocking member 23 , and the second covering film 2300 may cover the outer side and/or the inner side of the second supporting frame 230 . If the cage is shaped like a cage and has an inner cavity, the second covering film 2300 may also be disposed on the inner cavity or the outer surface of the second supporting frame 230 . In this embodiment, the second covering film 2300 covers the inner surface of the second supporting frame 230. The second covering film 2300 is used to directly contact the tissue. Compared with the second supporting frame 230, the second covering film 2300 directly contacts the tissue, which increases the contact area and reduces the The smaller part of the second occluder 23 has excessive pressure on the tissue, and the material has an irritating effect; in a modified embodiment, the second covering film 2300 covers at least part of the outer surface of the second supporting frame 230 .

The first covering film 2100 and the second covering film 2300 are used to prevent blood from one side of the defect from flowing into the defect. In this embodiment, the first covering film 2100 is disposed on the outer side of the first supporting frame 210 , and the second covering film 2300 is covering the inner side of the second supporting frame 230 .

The first cover film 2100 and the second cover film 2300 are made of polyester cloth, PTFE, PET or other polymer materials. The first support frame 210 is sewn on the first cover film 2100 by sutures, and the second support frame 230 is also The second cover film 2300 is sutured with sutures.

In other embodiments, the first cover film 2100 and the second cover film 2300 can be fixed on the first support frame 210 and the second support frame 230 respectively by other methods such as hot pressing or sticking. In the modified embodiment, the first cover film 2100 is omitted from the first blocking member 21 , and/or the second cover film 2300 is omitted from the second blocking member 23 .

As shown in FIG. 4 , in the modified embodiment, third slits 2125 spaced apart from the first slits 2123 are further formed between the plurality of first braided wires 2121 in the first support member 212 , and the second support member 214 includes a first The bundle of braided wires 2143 and the second bundle of braided wires 2145, the first bundle of braided wires 2143 and the second bundle of braided wires 2145 each include at least one second braided wire 2141, and the first bundle of braided wires 2143 passes through the first slit 2123, The second bundle of braided filaments 2145 passes through the third slit 2125 . This insertion method increases the insertion point between the first support member 212 and the second support member 214 , improves the fixing strength between the first support member 212 and the second support member 214 , and improves the strength of the first blocking member 21 . support performance.

In other embodiments, two gaps spaced apart from each other are formed between the plurality of second braided wires 2141, the first support member 212 includes two bundles of braided wires, each bundle of braided wires includes at least one first braided wire 2121, The two bundles of braided wires pass through a slit in the second braided wires 2141 respectively.

In other embodiments, three or more gaps are formed between the first braided wires 2121, the second support 214 includes three or more bundles of braided wires, and each bundle of braided wires includes at least one The second braided wire 2141, three or more bundles of braided wires respectively pass through three or more slits.

Optionally, as shown in FIG. 2 , at least one support ring of the first blocking member 21 includes two body segments 2104 and a protruding segment 2105 connected between the two body segments 2104 , and the protruding segment 2105 is disposed on the first A circumferential end of a support frame 210 protrudes radially away from the geometric center of the first support frame 210 . The body section 2104 is disposed adjacent to the geometric center of the first support frame 210 compared to the protruding section 2105 . Compared with the body segment 2104, the circumference occupied by the 2105 on the circumference of the first support frame 210 is smaller. Specifically, in this embodiment, the first support member 212 to the sixth support member 218 of the first support frame 210 are all support rings, and each support ring includes a protruding section 2105 and a protruding section 2105 connected to opposite sides of the protruding section 2105. The body section 2104 and the protruding section 2105 of each support ring are located on the peripheral area 2103 of the first blocking member 21 . During the sheath retracting process, the support rods on both sides of the protruding section 2105 are easy to fit together, which reduces the resistance of the support ring against deformation during the deformation process of the first blocking member 21 during sheath retracting, making sheath retracting smoother and labor-saving.

Preferably, each protruding section 2105 forms a convex tip; in this embodiment, each protruding section 2105 is an arc-shaped convex corner. In other embodiments, the protruding section 2105 may also be a pointed-shaped or other shaped protrusion.

As shown in FIGS. 1 and 5 , the circumferential end of the first support frame 210 extends toward the side where the tightening member 25 is located, that is, extends toward the inner side of the first blocking member 21 . That is, the circumferential end of the first support frame 210 of the first blocking member 21 extends obliquely toward one side of the second blocking member 23 . The inner side of the blocking member 21 extends; optionally, the circumferential end of the second support frame 230 of the second blocking member 23 extends obliquely to one side of the first blocking member 21 , that is, to the side of the second blocking member 23 . Inside extension. In this embodiment, the axis of the first support frame 210 passes through its geometric center, and the axis of the second support frame 230 passes through its geometric center.

Preferably, as shown in FIG. 5 , the included angle between the line connecting the geometric center of the first support frame 210 and its circumferential end and the radial direction of the first support frame 210 is a, where 0°<a<45°; In this embodiment, the included angle a is 20 degrees. Correspondingly, the included angle range between the line connecting the geometric center and the circumferential end of the second support frame 230 and the radial direction of the second support frame 230 is greater than 0 degrees and less than 45 degrees. This design is used to realize the rapid rebound of the occluder 20 after entering the human body through the conveyor, and the edges of the first occluder 21 and the second occluder 23 are smoothly attached to the tissue, which is convenient for the defect of the primary diaphragm and the subsequent The diaphragm was endothelialized to the two occluded discs.

As shown in FIG. 6, in other embodiments, each support member in the first blocking member 21a forms a planar support frame, that is, each supporting member in the first blocking member 21a is located on the same plane; the second sealing member 21a is located on the same plane; Each support member in the blocking member 23a forms a planar support frame, that is, each supporting member in the second blocking member 23a is located on the same plane. Therefore, the first blocking member 21a is parallel to the second blocking member 23a.

Various technical solutions of the first support frame 210 and the second support frame 230 in the present application are applicable to each other, and will not be repeated here.

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

As shown in FIG. 2 , the first blocking member 21 includes a first sleeve 2106 disposed in the central region thereof, and the tightening member 25 is connected to the first sleeve 2106 . The end of the support ring on the first support frame 210 away from the protruding section 2105 is fixedly connected to the first sleeve 2106; The support ring is connected to the first sleeve 2106 and surrounds 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 metallic material.

Correspondingly, the second blocking member 23 includes a second sleeve (not shown in the figure) disposed in the central region thereof, and the second sleeve is fixedly disposed at the geometric center of the second blocking member 23; the second blocking member The support ring of 23 surrounds the second sleeve to form a second support frame 230; the second sleeve of the second blocking member 23 is cylindrical and has a cavity, the adjustment section 251 or the locking section 253 end through the cavity. Preferably, the end of the adjustment 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 metallic material.

Preferably, a coil is provided at the geometric center of the first steel sleeve 2106 , and the tightening wire 25 passes through the coil and is stretched, and the intersection of the coil and the tightening wire is located in the geometry of the first blocking member 21 . on the center, so that the first blocking member 21 is subjected to a uniform pulling force.

Preferably, the first steel sleeve 2106 has two oppositely arranged openings and a cavity between the two openings; the coil is suspended on the steel sleeve 2106 through the two openings and the cavity. Optionally, the ends of several support rings are connected to the outer circumference of the first steel sleeve 2106, and are fixedly connected to the first steel sleeve 2106 by welding or bonding. The material of the first steel sleeve 2106 is stainless steel, nickel-titanium alloy or other biocompatible materials.

Optionally, the shape of the disk surface of the first blocking member 21 and the second blocking member 23 may be set to a circle, a polygon, an ellipse, a triangle or other irregular shapes, and the radial area of the first blocking member 21 is the same as that of the first blocking member 21. The radial areas of the two blocking members 23 may be the same or different. In this embodiment, the first blocking member 21 and the second blocking member 23 are both substantially hexagonal disk-shaped, and the radial area of the first blocking member 21 is equal to the radial area of the second blocking member 23 . In one embodiment, the area of the first blocking member 21 is smaller than the area of the second blocking member 23 .

The first cover film 2100 and the second cover film 2300 can be a flow blocking film, and can be selected as a non-degradable polymer material film with good biocompatibility, such as ePTFE or PET material; the first cover film 2100 and the second cover film 2300 Absorbable polymer material films, such as polylactic acid, polycaprolactone, polylactic acid-caprolactone copolymer, etc., can also be selected. The first covering film 2100 and the second covering film 2300 are fixed on the inner surface or the outer surface of the occlusion disc by means of sewing, heat sealing or gluing, etc., for occluding blood flow.

The support rings of the first support frame 210 and the second support frame 230 can be made of various biocompatible materials, that is, each support ring can be made of various biocompatible materials. Including materials commonly used in the manufacture of releasable medical devices, such as memory alloy materials, preferably nickel-titanium alloys; the first support frame 210 and the second support frame 230 can also be made of degradable materials, that is, each The support ring is made of degradable materials, such as polylactic acid PLA, polycaprolactone PCL, polyglycolide PGA or polydioxanone PDO, etc.; the first support skeleton 210 and The second support frame 230 may also use high molecular polymer materials or the like.

During use, the first occluder 21 is delivered by the sheath 30 from and deployed in the left atrium, and the second occluder 23 is delivered by the sheath 30 to and deployed in the right atrium . The tightening wire connected between the first blocking member 21 and the second blocking member 23 has flexibility and can be adjusted in length, and the tightening wire passes through the foramen ovale between the primary diaphragm and the secondary diaphragm; Pulling the adjustment section 251 at the proximal end, the tightening line is tightened, and the tightening line is gradually shortened, that is, the distance between the first blocking member 21 and the second blocking member 23 is gradually reduced, and the primary diaphragm and the The secondary diaphragms are close to each other and are clamped by the first blocking member 21 and the second blocking member 23. The first blocking member 21 covers the primary diaphragm and the secondary diaphragm around the foramen ovale, and the second blocking member 21 covers the primary diaphragm and the secondary diaphragm. The member 23 covers the primary diaphragm and the secondary diaphragm around the foramen ovale, that is, the openings on both sides of the foramen ovale in the left and right atrium are respectively covered by the first blocking member 21 and the second blocking member 23 . Since both the first blocking member 21 and the second blocking member 23 include a support frame and a flow blocking film arranged on the support frame, the covering films on both sides of the foramen ovale can prevent blood from flowing into the foramen ovale, thereby preventing the Blood flows from the left atrium to the right atrium for immediate closure. After the occluder 20 is implanted into the human body, the primary diaphragm and the secondary diaphragm crawl to the contact position of the first occluder 21 and the second occluder 23, so that the foramen ovale is closed after the endothelialization is completed, forming a complete room divider. Because the support rings of the first support frame 210 are interspersed or intertwined with each other through a plurality of braided wires, and the support rings of the second support frame 230 are also interpenetrated or intertwined with each other by a plurality of braided wires. Being integrated, the structures of the first support frame 210 and the second support frame 230 are more stable and firm. In the modified embodiment, the density of the supporting skeleton on the two blocking discs is sufficiently large, and the covering film is omitted, which will not affect the endothelialization of the two diaphragms to the blocking disc, and the foramen ovale channel will not form a shunt or the shunt is small. .

Please refer to FIG. 7 . FIG. 7 is a schematic structural diagram of another connection mode of a plurality of support rings of the plugging system of the present application, and another connection mode of the plurality of support rings and the first plugging member 21 in one of the above-mentioned embodiments. The structure is similar, the difference is that: the first support ring 212 and the third support ring 215 include a combined segment 2108 combined together; the first support ring 212 also includes a separation segment 2127 connected with the combined segment 2108, the third support ring 215 also includes a separation section 2157 connected with the coupling section 2108; the coupling section 2108 is closer to the geometric center of the first blocking member 21b than the

separation sections

2127 and 2157. At least some of the joined segments 2018 are located in the central region 2101 and at least some of the separated

segments

2127 , 2157 are located in the peripheral region 2103 .

As shown in FIG. 7 , the extending direction of the combining section 2108 is the same and is integrated into one body. In this embodiment, the multiple first braiding wires 2121 and the multiple third braiding wires 2151 located in the combining section 2108 are woven into one body, and the combining section 2108 The weaving method of the middle braided wire is not limited. In a modified embodiment, the plurality of first braided wires 2121 and the plurality of third braided wires 2151 located in the combining section 2108 are fixedly connected into one body by means of bonding, suture winding and knotting, welding or the like.

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

separation sections

2127 and 2157 extend in different directions, and the multiple first braiding wires 2121 and the multiple third braiding wires located in the separating

sections

2127 and 2157 are woven in different directions. The wires 2151 are separated from each other. As shown in the first embodiment, in the peripheral area 2103, the separation sections (such as separation sections 2127 and 2157) of adjacent support members extend in different directions, and the intersecting positions between the separation sections are in an interpenetrating relationship, such as the second support The member 214 includes a separation section 2147 located at least partially in the peripheral region 2103 away from the geometric center of the first blocking member 21b, the separation section 2127 of the first support member 212 and the separation section 2147 of the second support member 214 extend in different directions, and They are fixed to each other in the peripheral region 2103 by means of the above-mentioned interpenetrating connection.

Specifically, in this embodiment, in the middle region 2101 close to the geometric center of the occlusion disc 21b, the ends of two adjacent support rings are of a woven structure; for example, the first support 212 and the third support 215 are in The braided wires at the ends in the middle region 2101 of the blocking disc are wound into one body, that is, the first support 212 and the joint section 2108 of the third support 215 intersect, and the multiple first braided wires 2121 at the intersection are connected with the multiple wires. The third braided wire 2151 is wrapped in one piece. In the peripheral area 2103 , two adjacent support rings are connected by interpenetration, that is, in the peripheral area 2103 , the second supporting member 214 is located between the first supporting member 212 and the third supporting member 215 , and the second supporting member 214 and the The first support member 212 and the third support member 215 are inserted and connected.

Please refer to FIG. 8 . FIG. 8 is a schematic diagram of another structure of the support frame 210 a of the plugging system of the present application. The structure of the support frame 210 a is similar to the structure of the first support frame 210 in one of the above-mentioned embodiments, except that the difference is In that: the support frame 210a only includes three support rings, each support ring is formed by winding braided or side by side with a plurality of braided wires, the three support rings are arranged along the circumferential direction of the support frame 210a, and each support ring and The two adjacent support rings are interspersed and connected. The support frame 210a has only three support rings, with low metal coverage and high porosity on the disk surface, which is convenient for the patient to pass through the mesh formed by the support at the interatrial septum for subsequent ostomy. In addition, the low metal content also reduces the precipitation of heavy metal ions. risks of. In this embodiment, the support frame 210a is provided with an intersection between three support members in the peripheral area, and the intersection position adopts the way of interpenetration connection, and the support frame 210a does not include the intersection position between the supports in the central area.

Please refer to FIG. 9 . FIG. 9 is a schematic diagram of another structure of the support frame 210b of the plugging system of the present application. The structure of the support frame 210b is similar to the structure of the first support frame 210 in one of the above-mentioned embodiments, except for the difference. In that: the support frame 210b includes four support rings, and the four support rings are evenly arranged along the circumferential direction of the support frame 210b to form two pairs of support rings that are perpendicular to each other, wherein a pair of support rings arranged at intervals are wound by a plurality of braided wires Braided or arranged side by side, the other pair of supporting rings arranged at intervals are all surrounded by a supporting rod; the supporting rings surrounded by the supporting rod are interspersed in the supporting rods wound by a plurality of braided wires.

Please refer to FIG. 10. FIG. 10 is a schematic diagram of another structure of the blocking disk 21c of the blocking system of the present application. The structure of the blocking disk 21c is similar to the structure of the first blocking member 21 in one of the above-mentioned embodiments. The difference is that the blocking disc 21c is triangular in shape, and the support frame of the blocking disc 21c only includes three supporting rings, the three supporting rings are arranged along the circumferential direction of the blocking disc 21c, and two adjacent supporting rings are adjacent to each other. The ends at the geometric center are combined, and the three support rings in the blocking disc 21c are the first supporting ring, the second supporting ring and the third supporting ring respectively, and the blocking disc 21c is close to the position of the first sleeve in the middle area. There are 3 joint sections, the first support ring and the second support ring are integrated in a joint section, the first support ring and the third support ring are combined and integrated in a joint section, the second support ring and the third support ring are integrated and integrated in a joint section. The support rings are combined and integrated in a joint section, and the joint sections of adjacent support loops in the middle area can be connected by mutual weaving, suture, bonding or welding, so that the adjacent support rods in the joint section are along the extend in the same direction.

Please refer to FIGS. 11 to 14 , the support frame of the plugging disc 21d in FIG. 11 is formed by 8 support rings arranged along the circumferential direction of the plugging disc 21d; the support frame of the plugging disc 21e in FIG. 12 is composed of 12 support rings The support rings are arranged along the circumferential direction of the plugging disk 21e; the support frame of the plugging disk 21f in FIG. 13 is formed by 18 support rings arranged along the circumferential direction of the plugging disk 21f; the plugging disk 21g in FIG. 14 is formed The supporting skeleton is composed of 24 supporting rings arranged along the circumference of the blocking disk 21g; the more the supporting rings of the supporting skeleton are, the more the intersection points on each supporting ring will be, and the metal coverage will be higher after the disk surface is formed. The higher the support strength of the support frame, the better the support effect after the occluder enters the human body.

Please refer to FIG. 15 . FIG. 15 is a schematic diagram of another structure of the blocking disk of the blocking system of the present application. The structure of the blocking disk 21h is similar to the structure of the first blocking member 21 in one of the above-mentioned embodiments. The point is that the shape of the support ring of the blocking disk 21h has changed, that is, the support ring of the blocking disk 21h is a relatively narrow oval in the circumferential direction, and the braiding method of the support ring of the blocking disk 21h is the same as that of the first blocking disk 21h. The braiding method of the first support frame 210 of the component 21 is the same, and details are not repeated here.

The above is the implementation of the embodiments of the present application. It should be pointed out that for those of ordinary skill in the art, without departing from the principles of the embodiments of the present application, several improvements and modifications can also be made. These improvements and modifications are also It is regarded as the protection scope of this application.

Claims

An occluder for occluding defects in a vasculature, characterized in that the occluder comprises a first occlusion piece, the first occlusion piece comprises a first support frame, the first occluder The support frame includes a plurality of support members arranged along the circumferential direction of the first blocking member; the plurality of support members include a first support member and a second support member arranged adjacently, and the first support member includes a plurality of first support members. a braided wire, the second support member includes at least one second braided wire, and at least a part of the second braided wire in the second support member is inserted into the first gap formed between the plurality of first braided wires middle.
The occluder according to claim 1, wherein the first support member is a first support ring formed by surrounding the multiple first braided wires, and the second support member is a multiple second braided wire A second support ring is formed around the wire.
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.
The occluder according to claim 2, wherein a third slit spaced from the first slit is further formed between the plurality of first braided wires, and the second support ring comprises a first bundle Braided filaments and a second bundle of woven filaments, the first bundle of woven filaments and the second bundle of woven filaments both include at least one second woven filament, and the first bundle of woven filaments passes through the first slit, The second bundle of braided filaments passes through the third slit.
The occluder according to claim 2, wherein the plurality of support members further comprises a third support ring surrounded by a plurality of third braided wires, the second support ring is circumferentially located at the first Between the 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 passes through the gap formed between the plurality of second braiding wires pass through.
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 first braided wire The gap between the braided wires; or, the first support ring and the third support ring both include a combined segment and a separated segment, and the combined segment is relative to the distance from the separated segment to the geometry of the first blocking member The center is relatively close, and the plurality of first braided wires located in the combined section are combined with the plurality of third braided wires, and the plurality of first braided wires and the plurality of third braided wires located in the separation section are separated from each other .
The occluder according to claim 6, wherein the second support ring comprises a combination section and a separation section, and the combination section is relatively far from the geometric center of the first occluder relative to the separation section. More recently, the plurality of first braided filaments and the plurality of second woven filaments located in the joining section are combined together, and the plurality of first woven filaments and the plurality of second woven filaments located in the separation section are separated from each other.
The occluder according to claim 6 or 7, characterized in that, the plurality of first braided wires located in the joint section and other braided wires are braided and fixed to each other, or fixed by suture.
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, so 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 farther away from the 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.
The occluder according to claim 9, wherein the protruding section forms a convex tip.
The occluder according to claim 1, wherein the occluder further comprises a second blocking member and a tightening member, and the tightening member is connected to the first blocking member and the first blocking member. Between the two blocking members, adjusting the tightening member can change the distance between the first blocking member and the second blocking member.
The occluder according to claim 1, characterized in that, after the occluder is implanted, the side of the first occluder for holding the tissue is the inner side, and the circumference of the first support skeleton is on the inside. Extends distally towards the inside of the first occluder.
The occluder according to claim 12, wherein the included angle between the geometric center of the first support frame and its circumferential end and the radial direction of the first support frame is a, where 0°<a<45°.
The occluder according to claim 1, wherein the first blocking member comprises a first covering film disposed on the first supporting frame, and the second blocking member comprises a second supporting frame and a second cover film arranged on the second support frame.
The occluder according to claim 14, characterized in that, after the occluder is implanted, a side of the first occluder and the second occluder for clamping tissue is the inner side, The side of the first blocking member and the second blocking member facing away from the clamped tissue is the outer side, and the first covering film is arranged on the outer surface of the first supporting frame; and/or the first Two cover films are arranged on the inner surface of the second support frame.
An occlusion system comprising the occluder according to any one of claims 1 to 15, the system further comprising a conveyor for releasing the occluder.