WO2021129667A1

WO2021129667A1 - Intracavitary occluder

Info

Publication number: WO2021129667A1
Application number: PCT/CN2020/138650
Authority: WO
Inventors: 王永胜; 李安伟; 宋阅韬
Original assignee: 杭州唯强医疗科技有限公司
Priority date: 2019-12-23
Filing date: 2020-12-23
Publication date: 2021-07-01

Abstract

An intracavitary occlude (100), comprising: a mesh skeleton (11), wherein the mesh skeleton (11) is a hollow structure, and the mesh skeleton (11) comprises two end surfaces (111) and a lateral surface (112) connected between the two end surfaces (111); a flow blocking membrane (12) formed on the mesh skeleton (11), wherein the flow blocking membrane (12) comprises two end surfaces (121) and a lateral surface (122) connected between the two end surfaces (121); and a plug promotion member (13) formed on the surface of the intracavitary occlude (100). The lateral surface (112) of the mesh skeleton (11) and/or the lateral surface (122) of the flow blocking membrane (12) are/is a concave-convex surface/concave-convex surfaces. The intracavitary occlude (100) is small in size after being compressed, can quickly release and occlude a false cavity, and can promote the thrombosis of the false cavity.

Description

Intracavitary occluder

Technical field

This application relates to a medical device, in particular to an intracavity occluder.

Background technique

Interventional therapy is a new treatment method between surgery and medical treatment, including endovascular interventional and non-vascular interventional therapy. To put it simply, interventional therapy is to make tiny channels with a diameter of several millimeters in blood vessels and skin without surgery to expose the lesions, or through the original pipelines of the human body, under the guidance of imaging equipment (angiography machines, fluoroscopy machines, etc.) The following is the minimally traumatic treatment method for local treatment of the lesion. Interventional therapy has the advantages of less trauma, simplicity, safety, effectiveness, fewer complications, and significantly shorter hospital stays.

As an implant for interventional therapy, the occluding device can be used to occlude defect openings, or tissue breaks, internal cavities, and organ passages in the human body and/or animals. For example, the treatment of congenital heart disease, which has been widely used in clinical practice, includes the closure of defect openings such as atrial septal defect, ventricular septal defect, patent arterial sheath, etc. The main principle is to block the left and right heart chambers through a sealing device. The "leakage" between the left and right ventricles, the passage between the aorta and the pulmonary artery is blocked.

On the other hand, aortic dissection is a tear of the aortic intima and media due to various reasons. The aortic intima and media are separated, blood flows in, and the aortic lumen is divided into true and false lumen. Aortic dissection can see the separation or internal membrane between the true and false cavities, and the true and false cavities can communicate or not. The traditional aortic endovascular repair currently used for the treatment of aortic dissection is generally to achieve the purpose of aortic remodeling by sealing the primary rupture and reducing the pressure of the false cavity. However, data show that in 7% to 20% of cases, it is difficult to achieve the above goals because of the incomplete thrombosis of the false lumen of the aortic dissection. The existence of a distal tear and continuous perfusion (false cavity is not thrombotic) increase the risk of continued enlargement of the false cavity, correspondingly increasing the risk of further tearing of the dissection and rupture of the dissecting tumor, and also increasing the surgical resection after endovascular repair. The probability of intervention. At present, clinically, after the implementation of the standard aortic endovascular repair, the occlusion assist technology is used to promote the thrombosis of the false lumen.

The occluder is delivered to the defect opening, tissue breach, internal cavity, organ passage in the human body and/or animal body through interventional methods, including the human arteriovenous and/or heart, which can treat the local lesion . Among them, the occluder is required to have a reasonable design, such as a small body shape after compression, can quickly release and block the false cavity, can promote the thrombosis of the false cavity, and so on. Existing occluders often cannot meet the above requirements at the same time.

Summary of the invention

The purpose of the present application is to provide an intracavity occluder that has a small body shape after compression, can quickly release and block the false cavity, and can promote the thrombosis of the false cavity.

In order to solve the above technical problems, the present application provides an intracavity occluder, comprising: a net-like skeleton, the net-like skeleton is a hollow structure, the net-like skeleton includes two end surfaces and side surfaces connected between the two end surfaces A flow barrier film, formed on the net-like framework, the flow barrier film including two ends and side surfaces connected between the two ends; and a thrombus-promoting member formed on the surface of the cavity occluder; wherein , The side surface of the network skeleton and/or the side surface of the baffle film is a concave-convex surface.

In the intracavity occlusion device provided by the present application, the network skeleton is easy to compress, and after compression, the body is small and can be quickly released to block the false cavity; and a flow blocking film is formed on the network skeleton to release The posterior choke membrane can fit the false cavity better, and has a larger fit area, which can better seal the false cavity; in addition, the surface of the intracavity occluder in this case is formed with a plug-promoting member, after release, Forming the thrombogenic effect to disturb the blood in the false cavity and filling the false cavity can promote the thrombosis of the false cavity; further, the side surface of the mesh skeleton and/or the side surface of the choke membrane in this case is The concave-convex surface can improve the adaptability of the intracavity occluder, so that the intracavity occluder can bend in the false cavity with the shape of the false cavity, so as to fully fit the cavity wall to seal the false cavity.

Description of the drawings

In order to explain the technical solutions of the embodiments of the present application more clearly, the following will briefly introduce the drawings that need to be used in the embodiments. Obviously, the drawings in the following description are some embodiments of the present application, which are common in the field. As far as technical personnel are concerned, they can also obtain other drawings based on these drawings without creative work.

Fig. 1 is a three-dimensional schematic diagram of the intracavity occluder provided by the first embodiment of the present application.

Fig. 2 is a schematic cross-sectional view of the intracavity occluder provided by the first embodiment of the present application.

3 to 7 are schematic diagrams of the end faces of the skeleton of the intracavity occluder provided by the first embodiment of the present application.

Fig. 8 is an enlarged schematic cross-sectional view of a partial position of the intracavity occluder of Fig. 2 including a plug head and a sleeve head.

9 to 11 are schematic diagrams of the formation position of the plug-promoting member of the intraluminal occluder provided by the first embodiment of the present application, wherein the plug-promoting member of FIG. 9 is formed on the baffle membrane, and the propelling members of FIGS. 10 and 11 The bolt is formed on the net-shaped skeleton.

12 to 14 are schematic diagrams of partial shapes of the thrombus-promoting member of the intraluminal occluder provided by the first embodiment of the present application.

Fig. 15 is a schematic cross-sectional view of the intracavity occluder provided by the second embodiment of the present application.

16 is a schematic cross-sectional view of the intracavity occluder provided by the third embodiment of the present application.

Fig. 17 is a schematic cross-sectional view of the intracavity occluder provided by the fourth embodiment of the present application.

Detailed ways

The technical solutions in the embodiments of the present application will be clearly and completely described below in conjunction with the accompanying drawings in the embodiments of the present application. Obviously, the described embodiments are only a part of the embodiments of the present application, rather than all the embodiments. Based on the embodiments in this application, all other embodiments obtained by a person of ordinary skill in the art without creative work shall fall within the protection scope of this application.

Please refer to FIGS. 1 to 14 together. The first embodiment of the present technical solution provides an intracavity occluder 100, which includes: a net-like skeleton 11, which has a hollow structure, and the net-like skeleton 11 includes both ends 111 and the side 112 connected between the two end surfaces 111; the baffle film 12 is formed on the mesh frame 11, the baffle film 12 includes both end surfaces 121 and the side surface 122 connected between the two end surfaces 121, the baffle film 12 The maximum axial length of the mesh frame 11 is greater than or equal to the maximum axial stretch length of the mesh frame 11; and the plug-promoting member 13 is formed on the surface of the intracavity occluder 100; wherein, the side surface 112 and/or the hindrance of the mesh frame 11 The side surface 122 of the flow film 12 is a concave-convex surface. The plug-promoting member 13 is a slender linear or belt-shaped structure, one end of which is fixed on the surface of the occluder, and the other end is a free end.

In this embodiment, the reticular skeleton is easy to compress, and the body shape after compression is small and can be quickly released to block the false cavity; and the reticular skeleton is formed with a baffle film, and the baffle film can be better with the false cavity after release. The fitting area is large, so that the false cavity can be sealed better; in addition, the surface of the intracavity occluder in this case is formed with a plug-promoting member, after release, a slender plug-promoting member with a free end It can spoil the blood in the false cavity and fill the false cavity to reduce the volume of the false cavity, which can promote the thrombosis in the false cavity; further, the surface of the intracavity occluder in this case is a concave-convex surface, which can improve the cavity. The adaptability of the internal occluder allows the intracavity occluder to bend in the false cavity with the shape of the false cavity to fully fit the cavity wall to block the false cavity.

In this embodiment, the net-like skeleton 11 is a hollow columnar structure; in the radial direction along the net-like skeleton 11, the shape of the cross-sectional profile of the net-like skeleton 11 can be set to various shapes as required to adapt to different placement positions. demand.

Since the blood vessel wall is generally in the shape of an arc, it is preferred that in the radial direction along the mesh skeleton 11, at least part of the profile of the cross section of the mesh skeleton 11 is an arc, so that the intraluminal occluder 100 is released It can be closely attached to the tissue at the release position to have a better sealing effect.

For example, in this embodiment, as shown in FIG. 3, in the radial direction of the network skeleton 11, the cross-sectional shape of the network skeleton 11 is circular, that is, the network skeleton 11 has a hollow cylindrical structure. The rounded shape facilitates the delivery of the intracavity occluder 100, and the cylindrical structure also facilitates the adhesion of the intracavity occluder 100 to the inner wall of the false cavity.

For another example, in another embodiment, as shown in FIG. 4, in the radial direction of the network skeleton 11, the profile of the cross section of the network skeleton 11 is composed of two circular arcs with different radii. Ground, the angle range of the arc with a small radius is between 180° and 360°; the setting of this shape can be suitable for false cavities with asymmetric cavity shapes formed due to different pressures on the inner and outer walls, that is, beneficial The intraluminal occluder 100 fits with the inner wall of the false cavity having an asymmetric cavity shape.

For another example, in other embodiments, as shown in FIGS. 5 to 7, in the radial direction of the mesh skeleton 11, the cross-sectional shape of the mesh skeleton 11 can also be semicircular, crescent, and semicircular. Shape and so on.

Of course, the cross-sectional shape of the network skeleton 11 can also be other shapes, and is not limited to the above.

In this embodiment, the connection between the two ends 111 and the side 112 of the mesh skeleton 11 is provided with a transition fillet, that is, the two ends 111 and the side 112 are smoothly connected; this arrangement can prevent the intracavity occluder 100 from having The sharp edges and corners damage the blood vessels, which is also beneficial to the recovery of the intraluminal occluder 100.

In other embodiments, the connection between the two end surfaces 111 and the side surface 112 may not be provided with a transition fillet.

The net-like skeleton 11 is a grid structure, wherein the net-like skeleton 11 can be woven from filaments to form a grid structure, or can be formed by a cutting process. Among them, it is preferable that the net-like framework 11 is woven from filaments; the filaments may be metal wires, metal tubes, polymer filaments, polymer tubes, etc., or metal filaments, metal tubes, or polymer filaments. And a composite formed by at least two of the polymer tubes.

In one embodiment, the mesh frame 11 is woven from a plurality of wires made of memory alloys, such as nickel-titanium-based shape memory alloys, copper-nickel-based shape memory alloys, copper-aluminum-based shape memory alloys, and copper-zinc-based shape memory alloys. Alloys, iron-based shape memory alloys (Fe-Mn-Si, Fe-Pd), etc., can be released after compression to restore the original shape.

In a preferred embodiment, the net-like framework 11 is woven from a plurality of titanium nickel wires; among them, the nickel titanium wires have better elasticity and memory resilience, have a good adaptable shape, and can improve the blocking effect.

In this embodiment, the mesh skeleton 11 is woven from filaments to form a mesh structure, and the filaments converge at the center of the axial end faces 111 of the mesh skeleton 11 to form ends 115 respectively. Please refer to FIG. 8 together. The intracavity occluder 100 also includes sleeve heads 14 respectively sleeved at both ends. The sleeve head 14 is also provided with a plug head 15 outside, and the end of the plug head 15 away from the sleeve head 14 is formed with a thread (Figure Not shown), the thread is used to cooperate with other devices, for example, to cooperate with a conveyor. The material of the sleeve head 14 and the bolt head 15 are preferably stainless steel, such as 316L stainless steel. It should be noted that, for the convenience of presentation, the cross-section of the sleeve and the bolt are not shown in the cross-sectional view of FIG. 2, and the same applies to other similar cross-sectional views.

It is defined that the end of the mesh skeleton 11 used to connect with the conveyor is the proximal end of the mesh skeleton 11. In this embodiment, the end sleeved with the plug head 15 is the proximal end, and the end far away from the plug head 15 is the distal end. In this embodiment, the proximal surface of the mesh skeleton 11 is concave. This arrangement makes the proximal end of the mesh skeleton 11 less likely to deform when subjected to pressure, thereby facilitating the smooth release and retraction of the intracavitary occluder 100 .

In this embodiment, the side surface 122 of the baffle film 12 is concave and convex. In other words, the distances from at least multiple points of the side surface 122 of the baffle film 12 to the central axis of the mesh skeleton 11 are different; The adaptability of the intracavity occluder allows the intracavity occluder to bend in the false cavity with the shape of the false cavity to fully fit the cavity wall to seal the false cavity.

In one embodiment, the side surface 122 of the choke film 12 includes uniformly distributed unevenness along the radial direction of the mesh frame 11, and the side surface 122 of the choke film 12 is arranged symmetrically with respect to the axis along the mesh frame 11 .

In this embodiment, the side surface 122 of the choke film 12 is in the shape of wavy folds with varying regularity; specifically, as shown in FIGS. 1 and 2, the side surface 122 of the choke film 12 includes at least one ring-shaped wave trough 123 and multiple waves. There are two ring-shaped wave crests 124; adjacent wave crests 124 form wave troughs 123, and there is a smooth transition between wave crests 124 and wave troughs 123. For the convenience of description, the distance between the wave crest 124 of the choke film 12 and the central axis of the mesh skeleton 11 is defined as the height of the wave crest, and the distance between the wave trough 123 of the choke film 12 and the central axis of the mesh skeleton 11 is defined as the height of the wave trough. In an example, the height of each wave crest 124 is approximately the same, the height of each wave trough 123 is also approximately the same, and the distance between adjacent wave crests 124 is approximately the same. Preferably, the number of wave crests 124 of the baffle film 12 ranges from 2 to 6. In this embodiment, the number of wave crests 124 is three, and the number of wave troughs 123 is two.

Among them, the specific shape parameters of the wave crest 124 and the wave trough 123, such as aspect ratio, etc., can be set according to requirements such as the stretched length, which is not limited in this embodiment.

In another embodiment, the side surface 122 of the baffle film 12 may also have a uniform concave-convex shape different from the present embodiment. For example, the wave crest of the baffle film 12 is not ring-shaped but helical, so that the wave trough is also spiral. shape.

In another embodiment, the side surface 122 of the choke film 12 may also include unevenly distributed unevenness, such as irregular wave folds, such as the height of each wave crest is different, the height of each wave trough is different, and/or adjacent The distance between the crests is different and so on.

In the natural state, the axial length of the baffle film 12 is the same as the axial length of the mesh skeleton 11; when the mesh skeleton 11 is axially elongated, the baffle film 12 gradually expands, so that the baffle film 12 follows the mesh The skeleton 11 is axially elongated together, and the maximum axial length of the baffle film 12 is greater than or equal to the maximum axial extension length of the mesh skeleton 11.

In this embodiment, when the folds of the choke film 12 are all flattened, the axial length of the choke film 12 is greater than or equal to the maximum axial stretching length of the mesh skeleton 11, and when the intracavity occluder 100 is released, the mesh The shape skeleton 11 returns to its original shape, and the choke film 12 also returns to its fold shape. With this choke membrane structure, when the intraluminal occluder 100 needs to be compressed in a delivery sheath, the mesh skeleton 11 will not be unable to be compressed in the delivery sheath due to the inability of the choke membrane 12 to extend. That is, the baffle film 12 and the mesh skeleton 11 can be expanded and contracted together, so that the baffle film 12 bound to the mesh skeleton 11 does not restrict the axial stretching of the mesh skeleton 11; when the intracavity occluder 100 When released, the reticular skeleton 11 returns to its original shape, and the baffle membrane 12 also returns to the fold shape, which can increase the adhesion performance with the tissue at the released position and enhance the blocking effect.

It can be understood that in other embodiments, the side 122 of the net-like framework 11 may also be concave and convex; further, the undulations of the side 122 of the net-like framework 11 can be consistent with the undulations of the side 112 of the baffle film 12, that is, In the axial direction of the mesh skeleton 11, the undulating position of the side surface 122 of the reticular skeleton 11 is the same as the undulating position of the side surface 112 of the choke film 12.

The material of the baffle film 12 may be a material with good biocompatibility such as polytetrafluoroethylene (ePTFE) or polyethylene terephthalate (PET) film.

In one embodiment, the thickness of the flow blocking film 12 is 0.02 mm to 0.1 mm; preferably, the thickness of the flow blocking film 12 is 0.04 mm to 0.08 mm; more preferably, the thickness of the flow blocking film 12 is 0.04 mm. , 0.06 mm or 0.08 mm.

The baffle film 12 can be connected to the mesh skeleton 11 by means of sutures 16; the means of suture can be single-point suture. The suture 16 can be sewn to any one end or both ends of the mesh frame 11 in the axial direction, or can be sewn to any part between the two ends of the mesh frame 11; for example, the suture 16 is sewn to the sleeve 14 At the position, the suture 16 is sewn on the bolt head 15, and the suture 16 is sewn on the cylindrical surface of the net-shaped skeleton 11. The material of the suture 16 may be a material with good biocompatibility such as polytetrafluoroethylene.

In this embodiment, the baffle film 12 is wrapped around the end surface 111 and the outside of the side 112 of the mesh frame 11, and the baffle film 12 is sutured to the sleeve 14 by means of a single strand of single-point suture with sutures 16 (see Figure 2 ) And the intersection of the meshes of the metal wires of the mesh skeleton 11 (not shown in the figure).

The plug-promoting member 13 may be provided on part or all of the outer surface of the intracavity occluder 100. After the intraluminal occluder 100 is released, the elongated thrombus-promoting member 13 with a free end can disrupt the blood flow in the false cavity and fill the false cavity, reduce the volume of the false cavity, and promote thrombosis in the false cavity化.

The bolt-promoting member 13 is a slender linear or ribbon-shaped structure. The length of the bolt-promoting member 13 is 2-20mm and the width is 0.01-2mm. When the width is small, it can be called a linear structure. When the width is large, It can be called a ribbon structure.

The plug-promoting member 13 can be arranged on the mesh frame 11 or on the flow blocking membrane 12; in this embodiment, the plug-promoting member 13 is distributed on the outside of the flow blocking membrane 12. The thrombus-promoting member can be fixed to the outside of the baffle membrane 12 by stitching, gluing, etc.; and the fixing method can be single-strand fixation or multi-strand fixation; in this embodiment, as shown in Figures 2 and 9, The thrombus-promoting member 13 is fixedly connected with the baffle membrane 12 by suture, and is fixed by a single-strand suture. The extension direction of the plug-promoting member 13 is generally in a direction away from the flow blocking membrane 12, that is, generally extends to the outside of the intracavity occluder 100.

In other embodiments, as shown in FIGS. 10 and 11, the bolt-promoting member 13 can also be wound and fixed at the intersection of the mesh of the mesh skeleton 11; of course, the bolt-promoting member 13 can also be fixed to the mesh skeleton 11 Other positions of the grid. Wherein, the bolt-promoting member 13 may be single-strand winding and fixing, or multiple-strand winding and fixing.

In this embodiment, as shown in Figs. 2 and 9 to 11, each bolt-promoting member 13 has a bifurcation-free structure.

In other embodiments, the thrombus-promoting member 13 may also have a bifurcation structure, and the bifurcation result can increase the effect of the thrombus-promoting member to promote the thrombosis of the false cavity; wherein, the bifurcation of the thrombus-promoting member 13 can also have various configurations, Figures 12 to 14 show three bifurcation structures, one is unilateral uniform bifurcation, the other is bilateral interactive bifurcation, and the other is bilateral opposite bifurcation; it is understandable that the bolt-promoting member 13 The structure of is not limited to the structure shown in the figure, and may also have other structures.

The bolt-promoting member 13 may be composed of chemical synthetic fibers or natural animal and plant materials, such as wool, silk and the like. In this embodiment, the bolt-promoting member 13 is made of a linear or sheet-shaped PET material.

Referring to FIG. 15, the second embodiment of the present technical solution provides an intracavity occluder 100a. The intracavity occluder 100a in this embodiment is basically the same as the intracavity occluder 100 in the first embodiment. The flow film 12 is also wrapped around the end surface 111 and the outside of the side surface 112 of the mesh frame 11. The difference is that the side surface 112 of the mesh frame 11 is not columnar, but is roughly the same shape as the side surface 122 of the flow barrier film 12, that is The side surface 112 of the net-like framework 11 is also concave and convex, and the distances from at least multiple points of the side surface 112 of the net-like framework 11 to the central axis of the net-like framework 11 are different, and the side 112 of the baffle film 12 undulates It is consistent with the undulations of the side 122 of the mesh skeleton 11; this structure makes the choke membrane 12 fit more closely with the mesh skeleton 11, and can increase the axial adaptability of the intraluminal occluder 100a, so that it can conform to blood vessels structure.

Furthermore, in this embodiment, the side surface 112 of the mesh skeleton 11 is also in the form of wavy folds with varying regularity. The side surface 112 of the mesh skeleton 11 includes at least one ring-shaped wave trough 113 and a plurality of ring-shaped wave peaks 114. A wave trough 113 is formed between adjacent wave crests 114 of the skeleton 11, and a smooth transition is made between the wave crest 114 and the wave trough 113 of the mesh skeleton 11; the wave crests 124 of the choke film 12 correspond to the wave crests 114 of the mesh skeleton 11 one-to-one; The distance between adjacent wave crests 114 of the network skeleton 11 is the same.

Define the distance between the crest 114 of the reticular skeleton 11 and the central axis of the reticular skeleton 11 as the height of the crest 114 of the reticular skeleton 11, and define the distance between the trough 113 of the reticular skeleton 11 and the central axis of the reticular skeleton 11 as the reticular skeleton 11. The height of the troughs 113; in this embodiment, the heights of the crests 114 of the mesh skeleton 11 are approximately the same, and the heights of the troughs 113 of the mesh skeleton 11 are also approximately the same; the two ends of the baffle film 12 connecting the two end faces 121 The height of each wave crest 124 is smaller than the height of each wave crest 124 in the middle position, and the height of the wave crests 124 at both ends of the choke film 12 is slightly greater than the height of the wave crest 114 of the mesh skeleton 11 at the corresponding radial position. The height of each wave crest 124 in the middle position is much greater than the height of the wave crest 114 of the reticular skeleton 11 at the corresponding radial position; because the wavy reticular skeleton 11 has a larger stretchable length, the present embodiment is provided with a baffle film The height of each wave crest 124 at the middle position of 12 is much larger than the height of the wave crest 114 of the mesh skeleton 11 at the corresponding radial position, so that the stretchable length of the choke film 12 is relatively large, and it is easy to adapt to the mesh skeleton 11.

Preferably, the number of wave crests 124 and 114 ranges from 2 to 6. In this embodiment, the number of wave crests 124 and 114 are both four.

Among them, the specific shape parameters of the wave crests 124 and 114 and the

wave troughs

123 and 113, such as the aspect ratio, etc., can be set according to requirements such as stretching length, and are not limited in this embodiment.

In another embodiment, the side surface 112 of the reticular skeleton 11 may also have a uniform uneven shape different from that of the present embodiment. For example, the wave crest of the reticular skeleton 11 is not ring-shaped, but helical, so that the troughs are also helical. shape.

In another embodiment, the side surface 112 of the mesh frame 11 may also include unevenly distributed unevenness, such as irregular wave folds, for example, the height of each wave crest is different, the height of each wave trough is different, and/or adjacent The distance between the crests is different and so on.

In this embodiment, as shown in FIG. 3, in the radial direction of the mesh skeleton 11, the shape of the cross section of the mesh skeleton 11 is circular to facilitate the delivery of the intracavitary occluder 100, and The cylindrical structure also facilitates the adhesion of the intraluminal occluder 100 to the inner wall of the false cavity.

In another embodiment, as shown in FIG. 4, in the radial direction of the net-like skeleton 11, the profile of the cross-section of the net-like skeleton 11 is composed of two circular arcs with different radii. The angle range of the arc with a small radius is between 180° and 360°; the setting of this shape can be applied to false cavities with asymmetric cavity shapes formed due to the different pressures on the inner and outer walls, that is, beneficial to the cavity The occluder 100 is attached to the inner wall of the false cavity with an asymmetric cavity shape.

In other embodiments, referring to FIGS. 5 to 7, in the radial direction of the net-like skeleton 11, the cross-sectional shape of the net-like skeleton 11 may also be at least partially arc-shaped, for example, a semicircular shape. , Crescent shape and semicircle, etc.

In other embodiments, the cross-sectional shape of the network skeleton 11 can also be other shapes, and is not limited to the above.

In the illustration of this embodiment, the description is given by taking the plug-promoting member 13 being provided on the baffle membrane 12 as an example; of course, the plug-promoting member 13 may also be provided on the mesh frame 11.

In this embodiment, the mesh skeleton 11 with a concave-convex surface increases the axial adaptability of the intraluminal occluder 100, so that it can conform to the vascular structure, and the mesh skeleton 11 on the concave-convex surface enables the baffle film 12 to interact with The net-like skeleton 11 fits more closely.

It should be noted that the contents not mentioned in the description and the figures in this embodiment can refer to the description of the first embodiment, which will not be repeated here.

Referring to FIG. 16, the third embodiment of the present technical solution provides an intracavity occluder 100b. The intracavity occluder 100b in this embodiment is basically the same as the intracavity occluder 100a in the second embodiment. The flow film 12 also covers the outside of the end surface 111 and the side surface 112 of the mesh frame 11. The difference is that: in this embodiment, the heights of the wave peaks 124 of the flow film 12 are approximately the same, and the troughs 123 of the flow film 12 are approximately the same. The height of each wave crest 124 of the choke film 12 is also approximately the same. The height of each wave peak 124 of the choke film 12 is slightly greater than the height of the wave crest 114 of the mesh frame 11 at the corresponding position in the radial direction. The performance is better, which is beneficial to the smooth delivery of the intracavity occluder 100.

It should be noted that the contents not mentioned in the description and the figures in this embodiment can refer to the description of the first and second embodiments, and will not be repeated here.

Referring to FIG. 17, the fourth embodiment of the present technical solution provides an intracavity occluder 100c. The intracavity occluder 100c in this embodiment is basically the same as the intracavity occluder 100b in the third embodiment. The difference is that: the baffle film 12 is wrapped on the inner side of the end surface 111 and the side 112 of the mesh frame 11, that is, fixed inside the mesh frame 11; and the height of each wave peak 124 of the baffle film 12 is slightly smaller than the diameter To the height of the peak 114 of the mesh skeleton 11 at the corresponding position.

In this embodiment, the baffle film 12 is arranged in the mesh frame 11, which can reduce the load and release resistance of the intracavity occluder 100, facilitate smooth operation during delivery, and prevent the intracavity occluder 100 from being released. Damage to the baffle membrane during recovery. Further, the side surface of the flow blocking film 12 is a concave-convex surface, and the side surface of the network skeleton 11 is also a concave-convex surface, which can improve the efficiency of stitching the flow blocking film inside the skeleton.

As shown in FIG. 17, in this embodiment, the bolt-promoting member 13 is disposed on the mesh skeleton 11; specifically, referring to FIGS. 10 and 11, the bolt-promoting member 13 is wound and fixed on the mesh of the mesh skeleton 11 Of course, the bolt-promoting member 13 can also be fixed to other positions of the mesh of the mesh skeleton 11. In this embodiment, the baffle film 12 is arranged in the net-like framework 11, the net-like framework 11 is exposed, and the plug-promoting member 13 is arranged on the net-shaped framework 11, so as to facilitate the fixation of the plug-promoting member 13.

Of course, in other embodiments, the plug 13 can also be provided on the flow blocking membrane 12.

It should be noted that the contents not mentioned in the description and the drawings in this embodiment can refer to the description of the first to third embodiments, and will not be repeated here.

The intracavity occluder provided by the technical solution of the present application is made of a skeleton covered with a flow barrier film, and both the skeleton and the flow barrier film have good compressibility, so that the compressed volume of the intracavity occluder is small; In addition, the intracavity occluder provided by the technical solution of the present application is made of a skeleton coated with a baffle film, which can quickly return to its original shape when released, and has good adhesion performance after release; further, the intracavity occluder provided by the technical solution of the present application The maximum axial length of the baffle membrane is greater than or equal to the maximum axial extension length of the skeleton, which can be suitable for the closure of axially long organ passages, for example, when the intraluminal occluder is compressed in the delivery sheath , The baffle film can be elongated with the axial extension of the intraluminal occluder. After the intraluminal occluder is released at the diseased position and restores its shape, the baffle film can also change and cover the intraluminal occluder , It can completely prevent blood from entering the defect opening or tissue break through the intraluminal occluder, so as to complete the sealing of the defect opening or tissue break, etc.; because its baffle membrane does not limit the elongation of the skeleton, even if it has The longer axial length of the occluder can still be compressed in the sheath in a small size, and is especially suitable for interventional treatment of aortic dissection. The occluder is placed in the dissection false cavity, which can promote false The thrombosis of the cavity; in addition, the intracavity occluder provided by the technical solution of the present application adopts a concave-convex surface, which can improve the adaptability of the occluder, so that it can be bent with the shape of the false cavity in the false cavity, so as to fully adhere to the cavity. The wall of the cavity is closed to seal the false cavity; in addition, the intraluminal occluder provided by the technical solution of the present application is provided with embolization promoting members, which can further promote the thrombosis of the false cavity; on the other hand, the shape of the false cavity of different individuals is different. However, this application provides occluders with different cross-sections such as circular, two-arc splicing, semicircular, crescent, and semicircular for selection, which is more suitable for the shape of the false cavity, and improves the occluder and the interior of the false cavity. The fit.

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 principle of the embodiments of the present application, several improvements and modifications can be made, and these improvements and modifications are also Treated as the scope of protection of this application.

Claims

An intracavity occluder, including:

A net-like skeleton, the net-like skeleton is a hollow structure, and the net-like skeleton includes two end faces and side faces connected between the two end faces;

A baffle film formed on the net-like framework, the baffle film including two end surfaces and side surfaces connected between the two end surfaces; and

A thrombus-promoting member is formed on the surface of the occluder in the cavity;

Wherein, the side surface of the reticular skeleton and/or the side surface of the flow blocking film is a concave-convex surface.
The intraluminal occlusion device according to claim 1, wherein the choke film is coated on the outside of the mesh skeleton, and the maximum axial length of the choke film is greater than or equal to the mesh The maximum axial stretch length of the skeleton.
The intracavity occluder according to claim 2, wherein the side surface of the choke membrane includes at least one annular wave trough and a plurality of annular wave crests; among the plurality of wave crests of the choke membrane, The height of the two wave crests connecting the two end faces of the choke film is smaller than the height of each wave crest at the middle position; and the height of the wave crests at both ends of the choke film is slightly larger than the mesh skeleton at the corresponding radial positions The height of each wave peak in the middle position of the choke film is much larger than the height of the wave peak of the network skeleton at the corresponding radial position.
3. The intracavitary occluder according to claim 1, wherein the choke membrane is fixed inside the reticular skeleton.
4. The intracavity occlusion device according to claim 4, wherein the plug-promoting member is fixed on the mesh skeleton.
The intraluminal occlusion device according to any one of claims 1 to 5, wherein the side surface of the flow blocking membrane is a concave-convex surface; the side surface of the network skeleton is also a concave-convex surface; the flow blocking membrane The ups and downs of the side of the network are consistent with the ups and downs of the side of the network skeleton.
The intracavitary occluder according to any one of claims 1 to 5, wherein the side surface of the choke membrane includes at least one annular wave trough and a plurality of annular wave crests; Smooth transition between wave crest and trough.
The intracavity occluder according to any one of claims 1 to 5, wherein the connection between the end surface and the side surface of the mesh skeleton is provided with a transition fillet.
The intraluminal occlusion device according to any one of claims 1 to 5, wherein the end of the mesh skeleton for connecting with the conveyor is defined as the proximal end of the mesh skeleton, wherein the The proximal surface of the reticular framework is concave.
The intraluminal occlusion device according to any one of claims 1 to 5, wherein the thrombus-promoting member is a bifurcation-free structure or a bifurcation structure; and the bifurcation structure is a unilateral bifurcation structure or a bifurcation structure. Interactive bifurcation structure or bilateral opposite bifurcation structure.
The intraluminal occlusion device according to any one of claims 1 to 5, wherein the network skeleton is a hollow columnar structure; in the radial direction along the network skeleton, the network skeleton At least part of the profile of the cross section of the side surface is a circular arc.
The intracavitary occlusion device according to any one of claims 1 to 5, wherein in the radial direction of the network skeleton, the profile of the cross section of the side surface of the network skeleton is two sections with different radii Circular arc connection composition.