CN220109783U

CN220109783U - Plugging device and plugging system

Info

Publication number: CN220109783U
Application number: CN202320417931.6U
Authority: CN
Inventors: 胡学斌; 郭开开; 蔡毅珂; 高小龙
Original assignee: Individual
Current assignee: Individual
Priority date: 2023-03-08
Filing date: 2023-03-08
Publication date: 2023-12-01
Anticipated expiration: 2033-03-08

Abstract

The utility model provides a plugging device and a plugging system, wherein the plugging system comprises a conveying device and the plugging device, the conveying device is used for conveying the plugging device, the plugging device is used for plugging an aneurysm, and the plugging device comprises a plugging device body woven by braided wires; the plugging device body can be contracted or expanded, and the plugging device body is provided with a binding part at the proximal end and a woven mesh surface at the distal end. So dispose, make plugging device can with the better laminating in tumour chamber, and can not cause the damage to the aneurysm wall, can effectually avoid breaking of aneurysm, ensure the long-term treatment of plugging system to promote the security and the reliability of aneurysm shutoff.

Description

Plugging device and plugging system

Technical Field

The utility model relates to the technical field of medical instruments, in particular to a plugging device and a plugging system.

Background

Aneurysms are a common vascular disease that is primarily a manifestation of limitation, diffuse distension or distension of the arterial wall due to lesions or lesions of the arterial wall. Aneurysms are primarily characterized as swelling and pulsatile masses that can occur anywhere in the arterial system. An unbroken aneurysm generally does not cause any symptoms, but once the aneurysm breaks, it can have serious consequences. For example, rupture of a cerebral aneurysm can cause severe headache and damage brain cells, stress brain tissue, or cause vascular stenosis.

The main clinical treatment method is interventional embolism treatment, and the interventional treatment of the aneurysm mainly comprises spring coil embolism operation, covered stent implantation operation and blood flow guiding device implantation operation. Among them, coil treatment is the most common treatment method, and there are still many limitations, such as low packing density, easy puncturing of vascular tissue during operation, and recurrence and rupture risk of aneurysm after embolism. The difficulty of the implantation of the covered stent is great, and although the blood flow in the aneurysm can be isolated, the risk of covering other branch arteries of the blood vessel to obstruct normal blood flow exists. Blood flow guide placement also risks delayed rupture of the aneurysm and occlusion of other small branches.

The intratumoral turbulent flow device is used for treating the aneurysm, and the principle is that the plugging device is released in the aneurysm cavity of the aneurysm, so that the blood flow of the neck of the aneurysm is changed, and thrombus is induced in the aneurysm. The treatment method has less influence on the artery and does not influence the artery after the aneurysm is ruptured. However, the technology of the intratumoral turbulence device is still immature, and the existing intratumoral turbulence device often has the defects of low coverage rate, incapacitation of completely blocking blood from entering an aneurysm and easier compression of the wall of the aneurysm.

Thus, there is a need for an occlusion device and occlusion system that increases the metal coverage area, effectively blocks blood from entering the aneurysm, and facilitates rapid endothelialization of cells.

Disclosure of Invention

The utility model aims to provide a plugging device and a plugging system, wherein the plugging device can be better attached to a tumor cavity, can not damage the wall of an aneurysm, can effectively avoid the rupture of the aneurysm, ensure the long-term treatment effect of the plugging system, and improve the safety and reliability of the aneurysm plugging.

In order to achieve the above object, the present utility model provides an occlusion device for occluding an aneurysm, comprising an occlusion device body woven from braided filaments; the occlusion device body is capable of contracting or expanding; the plugging device body is provided with a binding part at the proximal end and a woven mesh surface at the distal end.

Optionally, the braided wires include a first braided wire and a second braided wire, the material of the first braided wire is a shape memory alloy material, and the material of the second braided wire is a developable metal material; wherein a part of the first braided wires are wound with the second braided wires.

Optionally, the number of strands of the braided filaments is 48-288.

Optionally, the number of strands of the first braided wire wound with the second braided wire is 5% to 10% of the total number of strands.

Optionally, the material of the first braided wire includes at least one of nickel-titanium alloy, cobalt-chromium alloy, MP35n alloy and stainless steel, and the material of the second braided wire includes at least one of platinum, iridium, gold, silver and tantalum and tungsten.

Optionally, the plugging device further comprises a choke film, wherein the choke film is coated at the proximal end of the plugging device body.

Optionally, the shape of the expanded occluding device body matches the shape of the lumen of the aneurysm.

Optionally, the bunching part comprises a free end formed by the bunching of the braided tows, and the free end is recessed towards the inside of the plugging device body.

Optionally, the free end faces towards the inside or outside of the occluding device body.

Optionally, the plugging device body includes first plugging structure and second plugging structure of mutual nestification, the second plugging structure sets up the outside of first plugging structure, just the second plugging structure is formed with at the proximal end restraint portion, and at the distal end formation the net face of weaving.

Optionally, a developing mark is arranged on the bunching part.

To achieve the above object, the present utility model also provides an occlusion system comprising a delivery device for delivering the occlusion device and an occlusion device according to any of the preceding claims.

Optionally, the occlusion system further comprises a sealing gel, the delivery device comprises a delivery catheter for delivering the sealing gel, the sealing gel is used for filling a gap between the occlusion device body and the aneurysm wall.

The plugging device and the plugging system provided by the utility model have at least one of the following advantages:

firstly, the plugging device provided by the utility model is provided with the bundling part of the braided wires only at the proximal end of the plugging device body (namely, the net-shaped braided structure), and the rest part of the plugging device body is the braided net surface, and as the braided net surface does not have the bundling part of the braided wires, namely, the bulge facing the aneurysm wall, the whole braided net surface of the plugging device body except the proximal end is smoothly transited, and the tip structure (namely, the bulge) of the aneurysm wall is not damaged. After the plugging device is implanted into the aneurysm, as the distal end is not protruded, the plugging device can be better attached to the aneurysm cavity, the plugging effect is better, meanwhile, the impact of the protrusion on the wall of the aneurysm is avoided, on one hand, the rupture of the aneurysm can be effectively avoided, the generation of postoperative complications of a patient is reduced and even avoided, and on the other hand, the risk of fatigue damage and fracture of the plugging device is also reduced, so that the long-term treatment effect of the plugging system can be ensured. Therefore, the plugging device of the utility model has the advantages of smooth and non-convex parts except the proximal end, avoiding the phenomenon of stress concentration, and being safer and more reliable. In addition, the outer surface of the whole plugging device is smoother, which is favorable for the climbing growth of cells and the acceleration of the endothelialization process. In addition, because the plugging device is not provided with the bulge, the shape of the plugging device can be more similar to that of an aneurysm, and after the plugging device is implanted into the aneurysm, the plugging device can also be provided with a higher metal coverage area in the aneurysm so as to accelerate the blood coagulation rate in the aneurysm and accelerate the formation of thrombus in the aneurysm.

Secondly, the blocking device provided by the utility model is provided with the blocking film at the proximal end, so that the aneurysm can be fully sealed, and blood flow is blocked from entering the aneurysm; the surface modification of the flow blocking film can also accelerate endothelialization of cells at the neck of the aneurysm, so that the aneurysm cannot be influenced after rupture, the risk of recurrence and rupture of the aneurysm after embolism of a plugging system is effectively reduced, and the safety and reliability of aneurysm plugging are improved.

Third, the occlusion system provided by the utility model further comprises a sealing gel, which can fill the gap between the occlusion device body and the aneurysm wall, so that blood in the artery cannot enter the inside of the aneurysm through the gap, and the tightness of the aneurysm can be improved.

Drawings

FIG. 1 is a schematic view of the overall structure of a plugging system according to a preferred embodiment of the present utility model;

FIG. 2a is a schematic view showing the state of the occluding device in a lateral aneurysm and exerting a force on the wall of the aneurysm in a comparative example, wherein the x-direction indicates the direction of the force of the occluding device on the wall of the aneurysm;

FIG. 2b is a schematic view showing the state of the occlusion device in a apical aneurysm in the comparative example;

FIG. 3 is a schematic view showing the occlusion device in an aneurysm and exerting force on the wall of the aneurysm in accordance with a preferred embodiment of the present utility model, wherein the x-direction indicates the direction of the force exerted by the occlusion device on the wall of the aneurysm;

FIG. 4 is a schematic illustration of the increased metal coverage area of the occluding device of a preferred embodiment of the present utility model, wherein the black areas in the figures refer to the increased metal coverage area of the occluding device of the present utility model in an aneurysm as compared to the occluding device of a comparative embodiment;

FIG. 5 is a schematic illustration of the manner in which the filaments are woven in accordance with a preferred embodiment of the present utility model;

FIG. 6a is a schematic view of a first plugging structure according to a preferred embodiment of the present utility model;

FIG. 6b is a schematic view of a second blocking structure according to a preferred embodiment of the present utility model;

FIG. 6c is a schematic view of a plugging device body according to a preferred embodiment of the present utility model formed by nesting a first plugging structure and a second plugging structure;

FIG. 7a is a schematic view of an occlusion device with a fluid blocking membrane positioned within a side aneurysm according to a preferred embodiment of the present utility model;

FIG. 7b is a schematic illustration of an occluding device with a barrier membrane positioned within an apical aneurysm in accordance with a preferred embodiment of the present utility model;

FIG. 8a is a schematic view showing the flow direction of external blood in the occlusion device without a blocking film in the comparative example, wherein the x-direction indicates the flow direction of blood in an artery;

FIG. 8b is a schematic view showing the flow direction of external blood in an occlusion device having a flow blocking film according to a preferred embodiment of the present utility model, wherein the x-direction, y-direction and y' -direction represent the flow direction of blood in an artery;

FIG. 9a is a schematic view showing the flow direction of external blood in the occluding device without the sealing gel filled in the comparative example, wherein the arrow direction indicates the flow direction of blood in the aneurysm;

FIG. 9b is a schematic view showing the flow direction of external blood in the sealing gel filled occluding device of the present utility model, wherein the arrow direction indicates the flow direction of blood in an aneurysm;

FIG. 10a is a schematic view of an occluding device in a contracted state in accordance with a preferred embodiment of the present utility model;

FIG. 10b is a schematic view of an occluding device in an expanded state in accordance with a preferred embodiment of the present utility model;

FIG. 11a is a schematic illustration of delivery of an occluding device to a side aneurysm using a delivery device in accordance with a preferred embodiment of the present utility model;

fig. 11b is a schematic view of delivery of an occluding device to an apical aneurysm using a delivery device according to a preferred embodiment of the present utility model.

In the figure: a plugging device body 1; braiding filaments 10; a first blocking structure 11; a second occluding structure 12; a bundling section 21; a woven mesh surface 22; a choke film 3; developing the mark 4; a delivery guidewire 5; a delivery sheath 6; a microcatheter 7; and a release 8.

Detailed Description

The utility model is described in further detail below with reference to the drawings and the specific examples. The advantages and features of the present utility model will become more apparent from the following description. It should be noted that the drawings are in a very simplified form and are all to a non-precise scale, merely for convenience and clarity in aiding in the description of embodiments of the utility model.

The terms "center," "longitudinal," "transverse," "length," "width," "thickness," "upper," "lower," "front," "rear," "left," "right," "vertical," "horizontal," "top," "bottom," "inner," "outer," "clockwise," "counter-clockwise," "axial," "radial," "circumferential," etc. refer to an orientation or positional relationship based on that shown in the drawings, merely for convenience of description and to simplify the description, and do not indicate or imply that the devices or elements referred to must have a particular orientation, be constructed and operated in a particular orientation, and therefore should not be construed as limiting the utility model.

In the present utility model, unless explicitly specified and limited otherwise, the terms "mounted," "connected," "secured," and the like are to be construed broadly and include, for example, either fixedly attached, detachably attached, or integrally formed; may be mechanically connected, may be electrically connected or may be in communication with each other; either directly, or through an intermediary, may be internal to the two elements or in an interactive relationship with the two elements, unless explicitly defined otherwise. The specific meaning of the above terms in the present utility model can be understood by those of ordinary skill in the art according to the specific circumstances. In the description of the present utility model, "proximal" generally refers to the end that is proximal to the operator; "distal" is the end opposite "proximal" and generally refers to the end that is remote from the operator, i.e., the end that first enters the body. In the description of the present utility model, the "interior" of the occluding device body refers to the direction towards the axis of the occluding device body; "external" means in a direction away from the axis of the occluding device body.

In order to solve the problems in the prior art, the utility model provides a novel plugging device and a plugging system for plugging an aneurysm, wherein the plugging device can be better attached to a lumen of the aneurysm and can reduce the impact on the inner wall of the aneurysm, so that the risk of rupture of the aneurysm and the risk of breakage and fracture of the plugging device can be reduced.

The utility model will be described in detail below with reference to the drawings and the preferred embodiments. The following embodiments and features of the embodiments may be complemented or combined with each other without conflict.

As shown in fig. 1, 3 and 5, the preferred embodiment of the present utility model provides an occlusion device for occluding an aneurysm, the occlusion device comprising an occlusion device body 1 braided by braiding wires 10, i.e. the occlusion device body 1 as a whole is a mesh-like braided structure. The occluding device body 1 can be contracted or expanded to ensure that the occluding device body 1 can be delivered in vivo when in a contracted state and can occlude an aneurysm when in an expanded state.

The occlusion device body 1 is formed with a bunching portion 21 at a proximal end and a woven mesh surface 22 at a distal end. It will be appreciated that the occluding device body 1 is formed with only one bunched portion 21 at the proximal end. It should also be understood that the "bunching portion" in the present utility model is an end structure formed by the braided filaments 10 bunched and constrained together at the proximal end of the occluding device body 1; the 'woven mesh surface' in the utility model refers to a smooth and non-convex outer mesh surface in the plugging device body 1; the "distal end" of the occluding device body 1 in the present utility model refers to all outer mesh surfaces except for the "proximal bunched portion 21".

To more clearly appreciate the advantages of the present utility model, please refer to the comparative examples provided in fig. 2a and 2b, as shown in fig. 2a and 2b, when both the proximal end 101 and the distal end 102 of the occluding device 100 have a bunched portion, the free ends of the braided filaments in the bunched portion at the distal end 102 of the occluding device 100 face the outside of the mesh braided structure, thereby forming a pointed structure (i.e., a bulge). In so doing, when the occluding device 100 is subjected to blood pressure in the x-direction as shown in fig. 2a and 2b, the pressure of the blood may cause the tip structure of the occluding device 100 to impact and press against the distal inner wall of the aneurysm, which may puncture the aneurysm to rupture the aneurysm, thereby causing injury to brain cells of the patient, pressing of brain tissue, or causing stenosis of arterial blood vessels of the patient; on the other hand, the aneurysm wall may also exert a certain pressure on the tip structure of the occluding device 100, thereby causing fatigue cracks, even breakage and fracture of the occluding device 100, affecting the therapeutic effect of the occluding device 100.

Referring to fig. 3, since the plugging device body 1 of the present embodiment is formed with the bunching portion 21 of the braided wire 10 only at the proximal end of the mesh-like braided structure, and the rest of the mesh-like braided structure is the braided mesh surface 22, since the braided mesh surface 22 has no bunching portion formed by the braided wire bundles, that is, no protrusion toward the wall of the aneurysm, the entire outer mesh surface of the plugging device body 1 except for the proximal end is smoothly transited, and the tip structure (i.e., protrusion) of the wall of the aneurysm is not damaged. As shown in fig. 3, after the plugging device body 1 is implanted in an aneurysm, since the distal end is not protruded, when the plugging device body 1 is subjected to the blood pressure in the x direction in fig. 3, the plugging device body 1 can be better attached to the lumen of the aneurysm, so that the plugging effect is better, and meanwhile, the impact of the protrusion on the wall of the aneurysm is avoided, on one hand, the rupture of the aneurysm can be effectively avoided, and the occurrence of postoperative complications of a patient is reduced or even avoided, and on the other hand, the risk of fatigue breakage and fracture of the plugging device is also reduced, so that the long-term treatment effect of the plugging system can be ensured. Therefore, the plugging device of the utility model has the advantages of smooth and non-convex parts except the proximal end, avoiding the phenomenon of stress concentration, and being safer and more reliable. In addition, the outer surface of the plugging device is smoother, which is beneficial to the cell climbing growth and the acceleration of the endothelialization process. In addition, the shape of the plugging device can be more similar to that of an aneurysm due to no bulge, and the plugging device can also have a higher metal coverage area in the aneurysm after being implanted in the aneurysm so as to accelerate the blood coagulation rate in the aneurysm and accelerate the formation of thrombus in the aneurysm.

Preferably, the agent for promoting the biological effect may be coated on at least part of the braided filaments. In one embodiment, a coagulant may be coated on at least a portion of the braided filaments so as to thrombus the aneurysm when the occluding device body 1 is implanted in the aneurysm, thereby avoiding long term impact of blood against the walls of the aneurysm to cause rupture of the aneurysm. Preferably, a coagulant is applied to all of the filaments.

In another embodiment, the endothelialization promoting agents may be coated on at least a portion of the braided filaments to promote endothelialization of the occluding device body 1. After the endothelialization process is accelerated, the occluding device body 1 can be made to complete endothelialization at the neck of the aneurysm more quickly. After endothelialization of the neck of the aneurysm is completed, blood can be prevented from entering the interior of the aneurysm, and the blood in the interior of the aneurysm can be quickly thrombosed, so that the risk of rupture of the aneurysm is reduced; in addition, endothelialization at the neck of the aneurysm can isolate the aneurysm from the artery, and even if the aneurysm breaks, the aneurysm cannot be influenced, so that the aneurysm can be thoroughly cured, and the recurrence of the aneurysm can be permanently prevented.

In yet another embodiment, a coagulant may be applied to one portion of the braided wire 10 and a endothelialization promoting agent may be applied to another portion of the braided wire 10 to provide a better therapeutic effect of the occluding device.

In other embodiments, a coating may be applied to at least a portion of the braided filaments 10 to enhance the occlusion and occlusion effect of the occluding device, provided that the size of the occluding device body 1 is controlled. The utility model is not limited in the type of coating applied to the braided wire 10, and the coating includes, but is not limited to, polyurethane, silicone rubber, hyaluronic acid, polyvinylpyrrolidone, and like coating materials.

In a preferred embodiment, the shape of the expanded occluding device body 1 matches the shape of an aneurysm; by such construction, the woven mesh surface 22 at the distal end of the occlusion device body 1 can be better attached to the wall of the aneurysm, and the metal coverage area of the occlusion device body 1 in the aneurysm can be increased. It will be appreciated that the black areas in fig. 4 are the increased metal coverage area of the occluding device of the present utility model in an aneurysm as compared to the occluding device 100 in the comparative example. Through increasing the metal coverage area of the plugging device body 1 in the aneurysm, the flow of blood in the aneurysm cavity can be effectively reduced, and then the accumulation and solidification of blood in the aneurysm are accelerated, the treatment effect of the plugging device is accelerated, and the risk of rupture of the aneurysm after operation is reduced.

Referring to fig. 1, in the present embodiment, when the occluding device body 1 is implanted in an aneurysm, the occluding device body 1 after expansion may take a nearly spherical shape to match the shape of the lumen of the aneurysm, thereby achieving a good occluding effect.

Referring back to fig. 2b, in the comparative example, the proximal end 101 of the occluding device 100 is provided with a constriction protruding towards the outside, at which time, for bifurcated vessels, the constriction of the proximal end 101 of the occluding device forms a local obstruction due to the relatively complex flow direction of blood in the artery, which may cause a degree of interference and unexpected disturbance to the flow direction of blood. On the one hand, when the blood in the artery flows through the neck of the aneurysm, the bunching part of the proximal end 101 can cause local obstruction to the blood, and the red blood cells in the blood can be flushed and collided with the bulge part for a long time, and can also cause rupture of the red blood cells, so that thrombus is generated; on the other hand, the flushing and collision of blood will also generate a reaction force to the occluding device body 1, thereby affecting the lifetime and therapeutic effect of the occluding device.

In order to solve the problem of the bunching portion of the proximal end 101 of the plugging device 100 in the comparative embodiment, it is preferable that the bunching portion 21 of the present embodiment does not protrude from the proximal mesh surface, that is, the free end (not shown) formed by bunching the braided filaments 10 is recessed toward the inside of the plugging device body 1, in other words, the free end is retracted into the recess of the proximal end, so that the proximal end of the plugging device body 1 is smoother, thereby facilitating the climbing and growth of cells and accelerating the endothelialization process of cells.

In an embodiment, referring to fig. 3, the free end may face towards the outside of the occluding device body 1. In other embodiments, the free end may also face the interior of the occluding device body 1.

In a preferred embodiment, the free end does not protrude from the nearest end of the plugging device body 1, so that the bunching portion 21 can be wrapped inside the plugging device body 1, and the proximal end of the plugging device body 1 does not bulge, so that interference of the free end on the blood flow direction in the artery can be avoided, impact of the blood on the plugging device body 1 can be avoided, the service life of the plugging device body 1 can be prolonged, and normal operation of the blood in the artery can be ensured. On the other hand, such an arrangement may further increase the smoothness of the proximal end of the occluding device body 1, thereby further accelerating the endothelialization process of the occluding device body 1 at the proximal end.

Further, the braiding wire 10 includes a first braiding wire and a second braiding wire, wherein a portion of the first braiding wire is wound with the second braiding wire, that is, all of the second braiding wire is wound on the corresponding first braiding wire. In one embodiment, the second braided wire may be provided as a sleeve that is capable of being slipped over the first braided wire. In another embodiment, the second braided wire may also be provided as a hollow helical spring structure that can be slipped over the first braided wire. The material of the first braided wire is a shape memory alloy material, so that the plugging device body 1 can have two states of contraction or expansion, and the plugging device body 1 can be conveniently used for plugging aneurysms during in-vivo conveying and expansion when in contraction. The second braided wire is made of a developable metal material, so that the braided wire material wound with the second braided wire comprises a metal elastic material and a radio-opaque material, and the position and the shape of the plugging device body 1 in the body and the plugging condition of the aneurysm can be conveniently obtained by an operator, thereby ensuring the plugging effect of the plugging device.

Preferably, the number of strands of the braided wire 10 is 48-288, so that the strength and toughness of the plugging device body 1 can be ensured, and the plugging device body 1 has a proper size, so that the plugging device body 1 can be conveniently conveyed in a body.

In a preferred embodiment, the number of strands of the first braided wire wound around the second braided wire accounts for 5% -10% of the total number of strands, so that on one hand, the plugging device body 1 can be ensured to have better developability, so that an operator can conveniently acquire the position and the shape of the plugging device body 1 in the body at any time, and master the progress of an operation; on the other hand, the smaller number of second braided wires does not affect the contraction and expansion of the first braided wires and the shape of the plugging device body 1 after heat treatment, thereby ensuring that the plugging device body 1 can be developed while also having better elasticity and stretchability.

The specific materials of the first braided wire and the second braided wire are not particularly limited, wherein the material of the first braided wire comprises at least one of nickel-titanium alloy, cobalt-chromium alloy, MP35n alloy and 316 stainless steel; in addition, the first braided wire may also include a polymeric material, such as a high strength and biodegradable polymeric material. The material of the second braided wire comprises platinum, iridium, gold, silver and at least one of tantalum and tungsten. The present utility model is not limited to the braiding method of the braided wire 10, and referring to fig. 5, in this embodiment, a plurality of braided wires 10 may be cross-braided in the vertical direction to form a uniform and dense occluding device body 1. In other embodiments, each strand of braided wire 10 may be braided in other manners as desired.

Referring to fig. 1, and fig. 6a to 6c, as a preferred embodiment, the occluding device body 1 includes a first occluding structure 11 and a second occluding structure 12 nested with each other, the second occluding structure 12 being disposed outside the first occluding structure 11, and the second occluding structure 12 being formed with a bunching portion 21 at a proximal end and a woven mesh surface 22 at a distal end, i.e., the second occluding structure 12 serves as an outer mesh surface of the occluding device body 1. So constructed, the contact area of the occluding device body 1 with blood in the aneurysm can be increased, thereby accelerating the accumulation and coagulation of blood in the aneurysm and accelerating the formation of thrombus in the aneurysm. The structure of the first plugging device 11 is not limited in the present utility model, and the woven mesh structure of the first plugging structure 11 only needs to be capable of being nested inside the second plugging structure 12.

In other embodiments, the occluding device body 1 may also comprise only one occluding structure; in still other embodiments, the occluding device body 1 may comprise three, four or more sequentially nested occluding structures.

In some examples, the number of braided strands of the first and second occluding structures 11 and 12 may be set to 36 and 72 strands, 72 and 72 strands, 36 and 144 strands, or 72 and 144 strands, respectively, to form occluding device bodies 1 of different structures. The specific number of strands of the first occluding structure 11 and the second occluding structure 12 in the present utility model may be set according to the size and shape of the aneurysm.

The plugging device body 1 can be shaped through a special die, and the plugging device body 1 can be prepared into aneurysms with different specifications in advance so as to be matched with aneurysms with different sizes, shapes and neck widths.

Preferably, the first blocking structure 11 may be woven from first woven wires wound with second woven wires, and the second blocking structure 12 may be woven from first woven wires wound with second woven wires or first woven wires not wound with second woven wires. Of course, in another embodiment, the first blocking structure 11 may also be woven from first woven filaments that are not wrapped around second woven filaments. The present utility model is not limited to the type of braiding filaments used to braid the first and second plugging structures 11 and 12.

Referring to fig. 7a and 7b, the occlusion device further comprises a blocking film 3, wherein the blocking film 3 is coated on the proximal end of the occlusion device body 1, so that external blood can be prevented from entering the interior of the occlusion device body 1 from the proximal end. In this embodiment, the choke film 3 may cover the whole bunching portion 21 and extend towards the distal end of the plugging device body 1 at both sides of the bunching portion 21, preferably, both ends of the choke film 3 may symmetrically extend to the maximum diameter of the plugging device body 1, so that the covering area of the choke film 3 may be increased, so as to more effectively prevent external blood from entering the interior of the plugging device body 1, and further facilitate the coagulation of blood inside the aneurysm. It should be understood that "external blood" in the present utility model refers to blood in an artery.

The material of the choke film 3 is not limited in the present utility model, and the material of the choke film 3 includes, but is not limited to, ePTFE or PET material. The connection mode of the choke film 3 and the plugging device body 1 is not limited in the utility model, for example, the choke film 3 can be coated on the outer wall of the proximal end of the plugging device body 1 by adopting a hot compress or sewing mode.

To further enhance the barrier effect of the fluid-blocking film 3 against external blood, in some embodiments, the surface of the fluid-blocking film 3 may be chemically treated. Specifically, the outer surface of one side of the choke film 3 can be coated with a high taurine solution with dioxane as a solvent, and one side of the choke film 3 with sodium sulfonate groups is arranged on the outer wall of the proximal end of the plugging device body 1, so that ester groups on the choke film 3 can be replaced by amide groups, the contact angle between the choke film 3 and water can be reduced, the hydrophilicity of the choke film 3 can be enhanced, the adhesion capability of endothelial cells on the surface of the choke film 3 can be improved, the climbing of the endothelial cells on the choke film 3 can be promoted, the endothelialization of the surface of the choke film 3 can be accelerated, and the sealing performance of the plugging device body 1 can be improved.

Taking an aneurysm of a bifurcated vessel as an example, the occlusion device is implanted. Referring first to the comparative example provided in fig. 8a, in the occlusion device 100 without a flow barrier, blood in an artery may impact the outer wall of the proximal end of the occlusion device 100 in the x-direction in fig. 8a, and a portion of the residual blood may enter the lumen of the tumor through the proximal portal of the occlusion device 100, thereby slowing down the blood coagulation rate in the aneurysm and prolonging the endothelialization time of the proximal outer wall of the occlusion device body 1. Referring next to fig. 8b, in the occluding device body 1 with the flow blocking film 3, when blood in an artery impacts the proximal outer wall of the occluding device body 1 in the x-direction in fig. 8b, the flow blocking film 3 can block and return blood from the y-direction and y' -direction in fig. 8b to other bifurcated vessels, thereby preventing blood from entering the interior of the aneurysm and accelerating endothelialization process at the neck of the aneurysm.

Referring to fig. 1, the bunching portion 21 may be provided with a developing mark 4, and the developing mark 4 may be developed under X-rays to determine the position of the proximal end of the occluding device.

In one embodiment, the visualization mark 4 may be configured as a metal ring to facilitate viewing the relative position of the occlusion device and the aneurysm. The metal ring may be an open-loop, closed-loop, or C-loop.

In one embodiment, a metal ring may be sleeved over the bunching portion 21.

In another embodiment, the metal ring and the bunched portion 21 may be bonded with biocompatible medical glue. In yet another embodiment, a metal ring may also be laser welded to the bunching portion 21 to achieve a secure connection of the developing device 4 to the bunching portion 21.

With continued reference to fig. 1, a preferred embodiment of the present utility model also provides an occlusion system comprising a delivery device for delivering the occlusion device and the occlusion device.

Further, the conveying device comprises a conveying guide wire 5, a conveying sheath tube 6, a micro-catheter 7 and a release device 8, one end of the conveying guide wire 5 is connected with the plugging device body 1, the other end is connected with the release device 8, the plugging device body 1 and the conveying guide wire 5 are movably arranged in the conveying sheath tube 6, and the micro-catheter 7 is movably sleeved outside the conveying sheath tube 6. In this embodiment, the occluding device is capable of passing smoothly through the lumen of the micro-catheter 7 having a minimum inner diameter of 0.017 inches and may be delivered to the aneurysm via the micro-catheter 7.

Further, a release point of the plugging device is arranged between the developing mark 4 and the distal end of the conveying guide wire 5. The occlusion system of the present utility model may employ an electrolytic or mechanical detachment method to separate the occlusion device from the delivery device, thereby implanting the occlusion device within the aneurysm.

Because the shape of the aneurysm cavity of different patients or different parts of the same patient is different, after the plugging device body 1 is released in the aneurysm, the plugging device body 1 cannot be fully attached to the wall of the aneurysm, and blood in an artery can enter the inside of the aneurysm through gaps between the plugging device body 1 and the wall of the aneurysm, so that the plugging effect of the aneurysm is affected.

Preferably, the occlusion system further comprises a sealing gel (not shown), and the delivery device further comprises a delivery catheter for delivering the sealing gel, wherein the sealing gel is used for filling a gap between the occlusion device body 1 and the wall of the aneurysm, so that blood in the artery cannot enter the interior of the aneurysm through the gap, and the tightness of the aneurysm can be improved. In particular, the delivery catheter may be disposed in the microcatheter 7, and after the distal end of the occluding device is abutted against the wall of the aneurysm, the sealing gel may be delivered to the gap between the occluding device and the wall of the aneurysm by the delivery catheter to fill the gap between the occluding device and the wall of the aneurysm. The utility model is not limited to the type of sealing gel, including but not limited to hydrogels, biogel, and the like.

In an embodiment, the proximal end of the plugging device body 1 is coated with the flow blocking film 3, and the gap between the plugging device body 1 and the aneurysm wall is filled with sealing gel, so that blood in an artery can be further prevented from entering the aneurysm cavity, the sealing performance of the aneurysm can be further improved, and the formation of thrombus in the aneurysm is facilitated. In addition, even if the aneurysm is ruptured at this time, the ruptured aneurysm does not interfere with the flow direction of blood in the artery because the aneurysm is completely separated from the artery at this time, thereby further ensuring the therapeutic effect and life safety of the patient.

An aneurysm with an occlusion device implanted in an arterial vessel that is not bifurcated is illustrated. Referring first to fig. 9a, in an occluding device not filled with sealing gel, blood in an artery may enter the aneurysm through a gap between the occluding device body 1 and the wall of the aneurysm, thereby affecting clotting of blood within the aneurysm. Referring next to fig. 9b, in the sealing gel filled occluding device body 1, the sealing gel in the slit can block blood to prevent blood from entering the aneurysm, thereby accelerating the formation of thrombus within the aneurysm.

The method of using the occlusion device and occlusion system of the present utility model is further described and comprises the steps of:

1) Referring to fig. 10a, during the delivery process, the occlusion device is always in a contracted state and placed inside the delivery sheath 6, and at this time, the microcatheter 7 is delivered towards the direction of the aneurysm and drives the occlusion device to move in the blood vessel until the distal end of the microcatheter 7 reaches the neck of the aneurysm;

2) Referring to fig. 10b, upon release, the delivery sheath 6 and microcatheter 7 are held stationary, pushing the delivery guidewire 5 so that the occluding device gradually moves toward the lumen of the aneurysm, during which time the occluding device self-expands out of the tether of the delivery sheath 6 while the occluding device gradually enters the lumen of the aneurysm.

3) Referring to fig. 11a and 11b, when the distal end of the occluding device is in abutment with the wall of the aneurysm, the detacher 8 attached to the proximal end of the delivery device is activated to fuse the delivery device to the detachment point of the occluding device, i.e., to detach the delivery guidewire 5 from the occluding device.

4) Finally, the delivery device is withdrawn from the patient, at which point the occluding device is placed within the aneurysm for embolization and treatment of the aneurysm.

It should be noted that, when the position of the plugging device needs to be adjusted or the plugging device needs to be replaced during the process of releasing the plugging device, the operator may directly withdraw the delivery guide wire 5 to retrieve the plugging device into the delivery sheath 6, and then release or directly replace the plugging device after readjusting the position of the plugging device.

In summary, the plugging device provided by the utility model has the bundle part 21 of the braided filaments only formed at the proximal end of the mesh braided structure, and the rest of the mesh braided structure is the braided mesh surface 22, and since the braided mesh surface 22 does not protrude towards the aneurysm wall, the whole mesh surface of the mesh braided structure is smoothly transited except the proximal end, and the tip structure (i.e. the protrusion) of the aneurysm wall is not damaged. After plugging device implants the aneurysm, owing to do not have the arch, make plugging device can with the better laminating of tumour chamber, the shutoff effect is better, has also avoided protruding impact to the aneurysm wall simultaneously, on the one hand can effectually avoid the aneurysm to break to reduce and avoided patient postoperative complication's production even, on the other hand also reduced the tired broken fracture risk of plugging device, thereby can ensure the long-term treatment of plugging system. Therefore, the other parts except the proximal end of the plugging device are smooth and have no bulges, so that the phenomenon of stress concentration is avoided, the plugging device is safer and more reliable, and in addition, the outer surface of the whole plugging device is smoother, thereby being beneficial to the climbing growth of cells and accelerating the endothelialization process. In addition, because the plugging device is not provided with the bulge, the shape of the plugging device can be more similar to that of an aneurysm, and after the plugging device is implanted into the aneurysm, the plugging device can also be provided with a higher metal coverage area in the aneurysm so as to accelerate the blood coagulation rate in the aneurysm and accelerate the formation of thrombus in the aneurysm.

The blocking device provided by the utility model is provided with the blocking film 3 at the proximal end, and can also fully seal the aneurysm, so that blood is prevented from entering the aneurysm. Particularly, the surface modification treatment of the flow blocking film 3 can also accelerate endothelialization of cells at the neck of the aneurysm, so that the aneurysm cannot be influenced after rupture, the risk of recurrence and rupture of the aneurysm after embolism of the plugging system is effectively reduced, and the safety and reliability of aneurysm plugging are improved.

The plugging system provided by the utility model further comprises sealing gel, so that gaps between the plugging device body and the aneurysm wall can be filled, and blood in an artery cannot enter the aneurysm through the gaps, so that the sealing performance of the aneurysm can be improved.

The above description is only illustrative of the preferred embodiments of the present utility model and is not intended to limit the scope of the present utility model, and any alterations and modifications made by those skilled in the art based on the above disclosure shall fall within the scope of the present utility model.

Claims

1. An occlusion device for occluding an aneurysm, comprising an occlusion device body woven from woven filaments; the occlusion device body is capable of contracting or expanding; the plugging device body is provided with a binding part at the proximal end and a woven mesh surface at the distal end, wherein the woven mesh surface is a smooth outer mesh surface without protrusions.

2. The occlusion device of claim 1, wherein said braided wires comprise a first braided wire and a second braided wire, said first braided wire being of a shape memory alloy material, said second braided wire being of a developable metallic material; wherein a part of the first braided wires are wound with the second braided wires.

3. The occlusion device of claim 2, wherein said braided filaments have a number of strands ranging from 48 to 288.

4. The occlusion device of claim 2, wherein the number of strands of said first braided wire wound with said second braided wire is between 5% and 10% of the total number of strands.

5. The occlusion device of claim 2, wherein the material of the first braided wire comprises at least one of nickel-titanium alloy, cobalt-chromium alloy, MP35n alloy, and stainless steel, and the material of the second braided wire comprises at least one of platinum, iridium, gold, silver, and tantalum and tungsten.

6. The occlusion device of claim 1, further comprising a flow blocking film wrapped around a proximal end of the occlusion device body.

7. The occlusion device of claim 1, wherein the shape of the body of the occlusion device after expansion matches the shape of an aneurysm cavity.

8. The occlusion device of claim 1, wherein said bunched portion includes a free end formed by the bunching of said braided filaments, said free end being recessed toward the interior of said occlusion device body.

9. The occlusion device of claim 8, wherein said free end faces either inside or outside of said occlusion device body.

10. The occlusion device of claim 1, wherein the occlusion device body comprises a first occlusion structure and a second occlusion structure nested within each other, the second occlusion structure being disposed outside the first occlusion structure, and the second occlusion structure being formed with the bunched portion at a proximal end and the braided mesh surface at a distal end.

11. The occlusion device of claim 1, wherein said bunched portion is provided with a developed logo.

12. A closure system comprising a delivery device for delivering the closure device and the closure device of any one of claims 1 to 11.

13. The occlusion system of claim 12, further comprising a sealing gel, wherein said delivery device comprises a delivery catheter for delivering said sealing gel, said sealing gel for filling a gap between said occlusion device body and an aneurysm wall.