WO2022206419A1 - Occluder and occlusion system - Google Patents

Abstract

An occluder (100) and an occlusion system. The occlusion system comprises an occluder (100) and a stent (200); the stent (200) is implanted into a true lumen (10) of an aortic dissection and is provided with pores; the occluder (100) comprises an anchoring portion (110) and a blocking portion (120) that are axially connected; the anchoring portion (110) comprises a first spring coil assembly, and the blocking portion (120) comprises a second spring coil assembly; the blocking portion (120) is configured to pass through the corresponding pores of the stent (200) so as extend from a tear (30) of the aortic dissection into a false lumen (20), and the anchoring portion (110) is arranged in an inner cavity of the stent (200), so that the occluder (100) is connected to the stent (200). The occlusion system can prevent the occluder (100) from misplacement or displacement and prevent a vascular wall from secondary injury, so that a good therapeutic effect is obtained.

Description

Translated fromChinese

一种封堵器及封堵系统An occluder and a occlusion system技术领域technical field

本发明涉及医疗器械技术领域，具体涉及一种封堵器及封堵系统。The invention relates to the technical field of medical devices, in particular to an occluder and an occlusion system.

背景技术Background technique

主动脉夹层是指主动脉腔内的血液从主动脉内膜撕裂处进入主动脉中膜，使得中膜分离并沿主动脉长轴方向扩展形成主动脉壁的真假两腔分离状态。目前针对主动脉夹层的治疗方法主要为主动脉腔内修复手术(EVAR)，其一般采用覆膜支架封堵夹层的破口，重建真腔血管通路，减少假腔血流使得假腔血栓化。Aortic dissection refers to a state of true and false two-lumen separation in which the blood in the aortic lumen enters the aortic media from the tear of the aortic intima, which separates the media and expands along the long axis of the aorta to form the aortic wall. At present, the main treatment for aortic dissection is endovascular aortic repair (EVAR), which generally uses a covered stent to seal the rupture of the dissection, reconstruct the vascular access of the true lumen, reduce the blood flow in the false lumen, and make the false lumen thrombosis.

EVAR主要是近端覆盖，或延伸至远端。对于主动脉夹层的远端破口，目前所用的治疗方法主要是通过同期或分期处理以达到较理想的主动脉重塑。但在临床研究中发现位于主动脉夹层远端的破口数量较多，且病理较为复杂，绝大多数患者的夹层远端存在三个以上的破口，处理较为困难。同时多数的远端破口位于腹主动脉的脏器区域，这一区域存在分支动脉，所以腔内治疗比较困难。而且由于远端破口的存在，难以实现假腔理想的血栓化，部分患者的假腔仍开放且持续增大并形成动脉瘤，甚至发生破裂。EVAR is mainly proximal coverage, or extended to the distal end. For the distal rupture of aortic dissection, the current treatment methods are mainly through simultaneous or staged treatment to achieve ideal aortic remodeling. However, in clinical studies, it was found that the number of ruptures at the distal end of aortic dissection was relatively large, and the pathology was more complex. Most patients had more than three ruptures distal to the dissection, which was difficult to handle. At the same time, most of the distal ruptures are located in the visceral region of the abdominal aorta, which has branch arteries, so endovascular treatment is difficult. Moreover, due to the existence of the distal rupture, it is difficult to achieve ideal thrombosis of the false lumen, and the false lumen of some patients is still open and continues to increase, forming aneurysms, or even rupture.

有鉴于此，现有技术中常采用假腔填塞术来促进假腔血栓化。假腔填塞术可利用弹簧圈进行填塞，由于假腔远端破口多，腔内容积大，临床上需要使用大量的弹簧圈才能达到致密的填塞，导致临床操作困难并产生高额医疗费用，不仅如此，传统的弹簧圈释放后没有固定装置，在假腔中存在移位风险，降低治疗成功率。一些改进型的弹簧圈预先连接于裸支架上，并随裸支架同步输送至体内进行释放，然而该类型的弹簧圈在输送时输送阻力大，且释放时容易发生缠绕，影响弹簧圈的定位准确性，以及弹簧圈的盘绕形态不受控制并较为松散，不能盘缩在破口处，降低其在破口处的封堵效果。在另一些改进型的弹簧圈结构中，弹簧圈在释放后通过锚定钩连接于裸支架上，但锚定钩易错位并偏离预定位置，且锚定钩还容易损伤血管壁，对血管壁造成二次伤害。In view of this, false lumen tamponade is often used in the prior art to promote false lumen thrombosis. False lumen tamponade can be filled with coils. Due to the large number of ruptures at the distal end of the false lumen and the large volume of the lumen, a large number of coils are required to achieve dense tamponade in clinical practice, resulting in difficult clinical operations and high medical costs. Not only that, there is no fixation device after the traditional coil is released, and there is a risk of displacement in the false cavity, which reduces the success rate of treatment. Some improved spring coils are pre-connected to the bare stent, and are delivered to the body synchronously with the bare stent for release. However, this type of coil has a large delivery resistance during delivery, and is prone to entanglement during release, which affects the accurate positioning of the coil. and the coiled shape of the coil is uncontrolled and relatively loose, and cannot be coiled at the breach, reducing its blocking effect at the breach. In other improved coil structures, the coil is connected to the bare stent through anchor hooks after release, but the anchor hooks are easy to dislocate and deviate from the predetermined position, and the anchor hooks are also easy to damage the blood vessel wall, causing damage to the blood vessel wall. Inflict secondary damage.

发明内容SUMMARY OF THE INVENTION

本发明的目的在于提供一种封堵器及封堵系统，所述封堵器可精准地释放在预定位置并牢固锚定，防止远期移位且避免对血管壁造成损伤。The purpose of the present invention is to provide an occluder and an occlusion system, the occluder can be accurately released at a predetermined position and firmly anchored, so as to prevent long-term displacement and avoid damage to the vessel wall.

为实现上述目的，本发明提供了一种封堵器，包括轴向连接的锚定部和栓塞部，所述锚定部包括第一弹簧圈组件，所述栓塞部包括第二弹簧圈组件。To achieve the above object, the present invention provides an occluder, comprising an axially connected anchor portion and a plug portion, wherein the anchor portion includes a first coil assembly, and the plug portion includes a second coil assembly.

可选地，所述第一弹簧圈组件包括第一定型丝和第一弹簧圈，所述第一定型丝为具有回弹性的金属丝并被配置为具有第一预定形状，所述第一弹簧圈套装在所述第一定型丝上并使所述第一弹簧圈组件形成所述第一预定形状；和/或，Optionally, the first spring coil assembly includes a first shaper wire and a first spring coil, the first shaper wire is a metal wire with resilience and is configured to have a first predetermined shape, the first shaper A spring coil is sleeved on the first setting wire and the first spring coil assembly is formed into the first predetermined shape; and/or,

所述第二弹簧圈组件包括第二定型丝和第二弹簧圈，所述第二定型丝为具有回弹性的金属丝并被配置为具有第二预定形状，所述第二弹簧圈套装在所述第二定型丝上并使所述第二弹簧圈组件形成所述第二预定形状。The second spring coil assembly includes a second setting wire and a second spring coil, the second setting wire is a metal wire with resilience and is configured to have a second predetermined shape, and the second spring coil is sleeved at the place. the second setting wire and the second spring coil assembly to form the second predetermined shape.

可选地，所述封堵器还包括显影元件，所述显影元件布置在所述锚定部与所述栓塞部的分界区；和/或，所述显影元件布置在所述锚定部及所述栓塞部上。Optionally, the occluder further includes a developing element, and the developing element is arranged in the boundary area between the anchor portion and the plug portion; and/or, the developing element is arranged on the anchor portion and on the plug portion.

可选地，所述第一弹簧圈组件的轴向尺寸小于或等于所述第二弹簧圈组件的轴向尺寸。Optionally, the axial dimension of the first coil assembly is smaller than or equal to the axial dimension of the second coil assembly.

可选地，所述第一弹簧圈组件的强度大于所述第二弹簧圈组件的强度。Optionally, the strength of the first coil assembly is greater than the strength of the second coil assembly.

可选地，所述第一定型丝和所述第二定型丝为同种材质，且所述第一定型丝的直径大于所述第二定型丝的直径以使所述第一弹簧圈组件的强度大于所述第二弹簧圈组件的强度。Optionally, the first setting wire and the second setting wire are made of the same material, and the diameter of the first setting wire is larger than the diameter of the second setting wire so that the first spring coil The strength of the assembly is greater than the strength of the second coil assembly.

可选地，所述第一定型丝的直径为0.008inch～0.020inch，所述第二定型丝的直径为0.005inch～0.012inch。Optionally, the diameter of the first shaping wire is 0.008 inch to 0.020 inch, and the diameter of the second shaping wire is 0.005 inch to 0.012 inch.

可选地，所述第一预定形状为螺旋线形、锥形、球形或六面体型中的任一种；和/或，所述第二预定形状为螺旋线形、锥形、球形或六面体形中的任一种。Optionally, the first predetermined shape is any one of a helix, a cone, a sphere or a hexahedron; and/or the second predetermined shape is a helix, a cone, a sphere or a hexahedron either.

可选地，当所述第一预定形状为锥形时，所述锥形的横截面沿远离所述 栓塞部的方向逐渐增大；和/或，当所述第二预定形状为锥形时，所述锥形的横截面沿远离所述锚定部的方向逐渐增大。Optionally, when the first predetermined shape is a cone, the cross section of the cone gradually increases in a direction away from the plug portion; and/or, when the second predetermined shape is a cone , the cross-section of the cone gradually increases in the direction away from the anchor portion.

可选地，所述栓塞部还包括促栓绒毛，所述促栓绒毛附着于所述第二弹簧圈组件上。Optionally, the plug portion further includes plug-promoting fluff, and the plug-promoting fluff is attached to the second coil assembly.

为实现上述目的，本发明还提供了一种封堵系统，包括支架和至少一个如前任一项所述的封堵器，所述栓塞部用于穿过所述支架上的孔隙并伸出所述支架的外部，所述锚定部用于设置在所述支架的内腔中并使所述封堵器连接于所述支架上。In order to achieve the above object, the present invention also provides an occlusion system, comprising a stent and at least one occluder according to any one of the preceding items, wherein the plug portion is used to pass through the hole on the stent and protrude out of the occluder. Outside the stent, the anchoring part is used to be arranged in the inner cavity of the stent and connect the occluder to the stent.

与现有技术相比，本发明的封堵器及封堵系统具有如下优点：Compared with the prior art, the occluder and the occlusion system of the present invention have the following advantages:

前述的封堵系统包括封堵器和支架，所述封堵器包括轴向连接的栓塞部和锚定部，所述锚定部包括第一弹簧圈组件，所述栓塞部包括第二弹簧圈组件，工作时，所述栓塞部穿过所述支架上的孔隙并延伸至所述支架的外部进而伸入主动脉夹层的破口处以对破口进行封堵，所述锚定部布置在所述支架的内腔中，并在所述第一弹簧圈组件的作用下使所述封堵器连接于所述支架上。利用所述第一弹簧圈组件将所述封堵器定位在所述支架上，并保持在预定位置，可避免错位而勾住支架的其他部位，并还不会对血管造成二次损伤。The aforementioned occlusion system includes an occluder and a stent, the occluder including an axially connected plug portion and an anchor portion, the anchor portion including a first coil assembly, and the plug portion including a second coil The assembly, when working, the embolization part passes through the hole on the stent and extends to the outside of the stent and then extends into the rupture of the aortic dissection to seal the rupture, and the anchoring part is arranged at the The occluder is connected to the stent under the action of the first spring coil assembly. Using the first spring coil assembly to position the occluder on the stent and keep it at a predetermined position can avoid dislocation and hook other parts of the stent without causing secondary damage to the blood vessel.

进一步地，所述第一弹簧圈组件包括第一定型丝和第一弹簧圈，所述第一定型丝为具有回弹性的金属丝并被配置为具有预定形状，所述第一弹簧圈套设在所述第一定型丝上，以使所述锚定部形成所述预定形状。利用所述第一定型丝保持所述锚定部的形状，使得所述封堵器可有效地连接于所述支架上，避免移位。此外，所述栓塞部具有类似的配置，使得栓塞部的第二弹簧圈有效地盘缩在破口处，以对破口进行有效封堵。Further, the first spring coil assembly includes a first setting wire and a first spring coil, the first setting wire is a metal wire with resilience and is configured to have a predetermined shape, and the first spring coil covers provided on the first shaping wire, so that the anchoring portion forms the predetermined shape. The shape of the anchoring portion is maintained by the first shaping wire, so that the occluder can be effectively connected to the stent to avoid displacement. In addition, the plug portion has a similar configuration, so that the second spring coil of the plug portion is effectively coiled at the breach to effectively seal the breach.

附图说明Description of drawings

附图用于更好地理解本发明，不构成对本发明的不当限定。其中：The accompanying drawings are used for better understanding of the present invention and do not constitute an improper limitation of the present invention. in:

图1是患者体内发生主动脉夹层区域的血管的剖视图；Figure 1 is a cross-sectional view of a blood vessel in the region of aortic dissection in a patient;

图2是本发明根据一实施例所提供的封堵器的结构示意图；2 is a schematic structural diagram of an occluder provided by the present invention according to an embodiment;

图3是本发明根据一实施例所提供的封堵器的结构示意图，图中所示的 栓塞部的形状与图2所示的封堵器之栓塞部的形状不同；Fig. 3 is the structural representation of the occluder provided by the present invention according to an embodiment, the shape of the plug portion shown in the figure is different from the shape of the plug portion of the occluder shown in Fig. 2;

图4是图2所示的封堵器的使用场景示意图；Fig. 4 is the schematic diagram of the usage scene of the occluder shown in Fig. 2;

图5是图3所示的封堵器的使用场景示意图；Fig. 5 is the schematic diagram of the usage scene of the occluder shown in Fig. 3;

图6是本发明实施例所提供的封堵器之栓塞部的结构示意图，图示中栓塞部被拉伸为直线状态。6 is a schematic structural diagram of a plug portion of an occluder provided by an embodiment of the present invention, in which the plug portion is stretched into a straight state.

图7是本发明实施例所提供的封堵器之第一定型丝的结构示意图；7 is a schematic structural diagram of the first shaping wire of the occluder provided by the embodiment of the present invention;

图8是本发明实施例所提供的封堵器之第一定型丝的结构示意图，图示中第一定型丝呈第一预定形状，且第一预定形状为锥形；8 is a schematic structural diagram of a first shaping wire of an occluder provided by an embodiment of the present invention, in which the first shaping wire is in a first predetermined shape, and the first predetermined shape is a cone;

图9是本发明实施例所提供的封堵器之第一弹簧圈的结构示意图，图示中第一弹簧圈被拉伸为直线状态；9 is a schematic structural diagram of a first spring coil of an occluder provided by an embodiment of the present invention, in which the first spring coil is stretched into a straight state;

图10是本发明实施例所提供的封堵器之第一弹簧圈组件的结构示意图，图示中第一弹簧圈组件呈锥形。10 is a schematic structural diagram of a first spring coil assembly of an occluder provided by an embodiment of the present invention, in which the first spring coil assembly is tapered.

[附图标记说明如下]：[reference numerals are explained below]:

10-真腔，20-假腔，30-破口；10-true cavity, 20-false cavity, 30-break;

100-封堵器，110-锚定部，111-第一定型丝，112-第一弹簧圈，120-栓塞部，121-第二定型丝，122-第二弹簧圈，123-促栓绒毛，130-显影元件；100-occluder, 110-anchoring part, 111-first setting wire, 112-first spring coil, 120-plug part, 121-second setting wire, 122-second spring coil, 123-plug fluff, 130 - developing element;

200-支架。200 - bracket.

具体实施方式Detailed ways

以下通过特定的具体实例说明本发明的实施方式，本领域技术人员可由本说明书所揭露的内容轻易地了解本发明的其他优点与功效。本发明还可以通过另外不同的具体实施方式加以实施或应用，本说明书中的各项细节也可以基于不同观点与应用，在没有背离本发明的精神下进行各种修饰或改变。需要说明的是，本实施例中所提供的图示仅以示意方式说明本发明的基本构想，遂图式中仅显示与本发明中有关的组件而非按照实际实施时的组件数目、形状及尺寸绘制，其实际实施时各组件的型态、数量及比例可为一种随意的改变，且其组件布局型态也可能更为复杂。The embodiments of the present invention are described below through specific specific examples, and those skilled in the art can easily understand other advantages and effects of the present invention from the contents disclosed in this specification. The present invention can also be implemented or applied through other different specific embodiments, and various details in this specification can also be modified or changed based on different viewpoints and applications without departing from the spirit of the present invention. It should be noted that the drawings provided in this embodiment are only to illustrate the basic concept of the present invention in a schematic way, so the drawings only show the components related to the present invention rather than the number, shape and the number of components in actual implementation. For dimension drawing, the type, quantity and proportion of each component can be changed at will in actual implementation, and the component layout may also be more complicated.

另外，以下说明内容的各个实施例分别具有一或多个技术特征，然此并 不意味着使用本发明者必需同时实施任一实施例中的所有技术特征，或仅能分开实施不同实施例中的一部或全部技术特征。换句话说，在实施为可能的前提下，本领域技术人员可依据本发明的公开内容，并视设计规范或实作需求，选择性地实施任一实施例中部分或全部的技术特征，或者选择性地实施多个实施例中部分或全部的技术特征的组合，借此增加本发明实施时的弹性。In addition, each embodiment of the following description has one or more technical features, but this does not mean that the person using the present invention must implement all the technical features in any embodiment at the same time, or can only implement different embodiments separately. One or all of the technical features of the . In other words, under the premise of possible implementation, those skilled in the art can selectively implement some or all of the technical features in any embodiment according to the disclosure of the present invention and depending on design specifications or implementation requirements, or The combination of some or all of the technical features in the multiple embodiments is selectively implemented, thereby increasing the flexibility of the implementation of the present invention.

如在本说明书中所使用的，单数形式“一”、“一个”以及“该”包括复数对象，复数形式“多个”包括两个以上的对象，除非内容另外明确指出外。如在本说明书中所使用的，术语“或”通常是以包括“和/或”的含义而进行使用的，除非内容另外明确指出外，以及术语“安装”、“相连”、“连接”应做广义理解，例如，可以是固定连接，也可以是可拆卸连接，或一体地连接。可以是机械连接，也可以是电连接。可以是直接相连，也可以通过中间媒介间接相连，可以是两个元件内部的连通或两个元件的相互作用关系。对于本领域的普通技术人员而言，可以根据具体情况理解上述术语在本发明中的具体含义。As used in this specification, the singular forms "a," "an," and "the" include plural referents, and the plural forms "a plurality" include two or more referents unless the content clearly dictates otherwise. As used in this specification, the term "or" is generally employed in its sense including "and/or" unless the content clearly dictates otherwise, and the terms "installed", "connected", "connected" shall be To be understood in a broad sense, for example, it may be a fixed connection, a detachable connection, or an integral connection. It can be a mechanical connection or an electrical connection. It can be directly connected, or indirectly connected through an intermediate medium, and it can be the internal communication between two elements or the interaction relationship between the two elements. For those of ordinary skill in the art, the specific meanings of the above terms in the present invention can be understood according to specific situations.

为使本发明的目的、优点和特征更加清楚，以下结合附图对本发明作进一步详细说明。需说明的是，附图均采用非常简化的形式且均使用非精准的比例，仅用以方便、明晰地辅助说明本发明实施例的目的。附图中相同或相似的附图标记代表相同或相似的部件。In order to make the objects, advantages and features of the present invention clearer, the present invention will be further described in detail below with reference to the accompanying drawings. It should be noted that, the accompanying drawings are all in a very simplified form and in inaccurate scales, and are only used to facilitate and clearly assist the purpose of explaining the embodiments of the present invention. The same or similar reference numbers in the drawings represent the same or similar parts.

图1示出了患者体内发生主动脉夹层区域的血管的剖视图，图2及图3是本发明实施例所提供的封堵器100的结构示意图，图4及图5是所述封堵器100的使用场景示意图。FIG. 1 shows a cross-sectional view of a blood vessel in a region of aortic dissection in a patient, FIGS. 2 and 3 are schematic structural diagrams of anoccluder 100 provided by an embodiment of the present invention, and FIGS. 4 and 5 are theoccluder 100 Schematic diagram of the usage scenario.

如图1所示，当患者发生主动脉夹层时，主动脉内膜撕裂，使得中膜分离而在血管中形成真腔10和假腔20，且所述真腔10和所述假腔20通过破口30连通。本发明实施例的目的在于提供一种封堵器100(如图2及图3所示)，所述封堵器100可在主动脉夹层的治疗中用于填塞所述假腔20并封堵所述破口30，以阻隔血流进入所述假腔20，促进所述假腔20血栓化(如图4及图5所示)。As shown in FIG. 1 , when aortic dissection occurs in a patient, the intima of the aorta is torn, so that the media is separated to form atrue lumen 10 and afalse lumen 20 in the blood vessel, and thetrue lumen 10 and thefalse lumen 20 Communication is through thebreach 30 . The purpose of the embodiments of the present invention is to provide an occluder 100 (as shown in FIG. 2 and FIG. 3 ), theoccluder 100 can be used to pack thefalse lumen 20 and occlude it in the treatment of aortic dissection Thebreach 30 is used to block blood flow from entering thefalse lumen 20 and promote thrombosis of the false lumen 20 (as shown in FIG. 4 and FIG. 5 ).

请参考图2及图3，所述封堵器100包括相互连接的锚定部110和栓塞部 120，所述锚定部110和所述栓塞部120均包括弹簧圈组件，后文中将所述锚定部110的所述弹簧圈组件称之为第一弹簧圈组件，将所述栓塞部120的所述弹簧圈组件称之为第二弹簧圈组件。所述封堵器100可用于与一支架200配合使用以对主动脉夹层进行治疗，所述支架200为裸支架，其上形成有孔隙。请重点参考图4及图5，工作时，所述支架200植入主动脉的真腔10中，所述封堵器100的所述栓塞部120穿过所述支架200上的所述孔隙并伸出所述支架200的外部，进而从破口30处伸入假腔20并封堵破口30。所述锚定部110布置在所述支架200的内腔中，并在所述第一弹簧圈组件的作用下使所述封堵器100连接于所述支架200上。本实施例中，所述支架200先输送并释放在主动脉的真腔10中，然后再将所述封堵器100输送并释放，两者分开输送，减小输送阻力，易于通过血管，并且利用所述第一弹簧圈组件来锚定所述封堵器100，可避免其错位，提高定位精度，并还避免对血管壁造成损伤。本发明实施例中，为使所述锚定部110保持在所述支架200的内腔中，所述第一弹簧圈组件的至少部分区域的横截面的面积可大于所述孔隙的面积。此外，本文中将所述栓塞部120与所述锚定部110的连接方向(也即从所述栓塞部120到所述锚定部110的方向，或者所述锚定部110到所述栓塞部120的方向)定义为所述封堵器100的轴线方向。Please refer to FIG. 2 and FIG. 3 , theoccluder 100 includes ananchor portion 110 and aplug portion 120 that are connected to each other. Both theanchor portion 110 and theplug portion 120 include a coil assembly, which will be described later. The spring coil assembly of theanchor portion 110 is referred to as a first coil assembly, and the spring coil assembly of theplug portion 120 is referred to as a second coil assembly. Theoccluder 100 can be used in combination with astent 200 to treat aortic dissection. Thestent 200 is a bare stent with pores formed thereon. Please refer to FIG. 4 and FIG. 5 , during operation, thestent 200 is implanted in thetrue lumen 10 of the aorta, and theembolic portion 120 of theoccluder 100 passes through the pores on thestent 200 and Thestent 200 extends out of thebracket 200 , and then extends into thefalse cavity 20 from thebreach 30 and seals thebreach 30 . The anchoringportion 110 is arranged in the inner cavity of thestent 200 and connects theoccluder 100 to thestent 200 under the action of the first spring coil assembly. In this embodiment, thestent 200 is first delivered and released in thetrue lumen 10 of the aorta, and then theoccluder 100 is delivered and released. The two are delivered separately, which reduces the delivery resistance and facilitates passage through the blood vessel. Using the first coil assembly to anchor theoccluder 100 can avoid its dislocation, improve positioning accuracy, and also avoid damage to the vessel wall. In this embodiment of the present invention, in order to keep the anchoringportion 110 in the inner cavity of thestent 200 , the cross-sectional area of at least a part of the first coil assembly may be larger than the area of the aperture. In addition, herein, the connection direction of theplug portion 120 and the anchor portion 110 (that is, the direction from theplug portion 120 to theanchor portion 110 , or theanchor portion 110 to the plug The direction of the occluder 120 ) is defined as the axial direction of theoccluder 100 .

较佳地，所述第一弹簧圈组件包括第一定型丝111和第一弹簧圈112，所述第一定型丝111为具有回弹性的金属丝并被配置为具有第一预定形状，所述第一弹簧圈112套装在所述第一定型丝上并使所述第一弹簧圈组件形成所述第一预定形状。同理，所述第二弹簧圈组件可具有与所述第一弹簧圈组件相类似的配置。具体地，所述第二弹簧圈组件包括第二定型丝121和第二弹簧圈122，所述第二定型丝121为具有回弹性的金属丝并被配置为具有第二预定形状，所述第二弹簧圈122套装在所述第二定型丝121上并使所述第二弹簧圈组件形成所述第二预定形状。在将所述封堵器100输送至血管内的过程中，所述第一弹簧圈组件和所述第二弹簧圈组件通常被拉伸为直线形态，而当所述封堵器100在血管中被释放时，在所述第一定型丝111的回弹力的作用下，所述第一弹簧圈组件恢复至所述第一预定形状，在所述第二定型丝121 的回弹力的作用下，所述第二弹簧圈组件恢复至所述第二预定形状。也就是说，本发明实施例中通过所述第一定型丝111保持所述第一弹簧圈组件的形状，使得所述封堵器100有效地连接于所述支架200上，避免移位。并还利用所述第二定型丝121保持所述第二弹簧圈组件的形状，使得所述第二弹簧圈组件盘缩在破口30处，以有效封堵破口30，促进假腔血栓化。所述第一弹簧圈组件及所述第二弹簧圈组件的具体形状及成型方法将在后文中介绍。Preferably, the first spring coil assembly includes afirst setting wire 111 and afirst spring coil 112, thefirst setting wire 111 is a metal wire with resilience and is configured to have a first predetermined shape, Thefirst spring coil 112 is sleeved on the first setting wire and makes the first spring coil assembly form the first predetermined shape. Likewise, the second coil assembly may have a similar configuration as the first coil assembly. Specifically, the second spring coil assembly includes asecond setting wire 121 and asecond spring coil 122. Thesecond setting wire 121 is a metal wire with resilience and is configured to have a second predetermined shape. Two spring coils 122 are sleeved on thesecond setting wire 121 and make the second spring coil assembly form the second predetermined shape. During the delivery of theoccluder 100 into the blood vessel, the first coil assembly and the second coil assembly are generally stretched into a linear shape, and when theoccluder 100 is in the blood vessel When released, under the action of the resilience of thefirst setting wire 111, the first spring coil assembly returns to the first predetermined shape, and under the action of the resilience of thesecond setting wire 121 , the second spring coil assembly is restored to the second predetermined shape. That is, in the embodiment of the present invention, the shape of the first spring coil assembly is maintained by thefirst shaping wire 111, so that theoccluder 100 is effectively connected to thestent 200 to avoid displacement. And also use thesecond setting wire 121 to maintain the shape of the second coil assembly, so that the second coil assembly is coiled at thebreach 30, so as to effectively block thebreach 30 and promote false lumen thrombosis. . The specific shapes and forming methods of the first spring coil assembly and the second spring coil assembly will be introduced later.

所述锚定部110用于布置在所述支架200的内腔中，也即所述锚定部110保持在主动脉的真腔10内，于此情况下，应在确保所述封堵器100能够有效连接于所述支架200上的前提下(也即所述第一弹簧圈组件不能穿过所述支架200上的孔隙)，尽可能地减小所述第一弹簧圈组件的尺寸，以尽可能地减少产生血栓的可能性。通常所述第二弹簧圈组件的轴向尺寸大于或等于所述第一弹簧圈组件的轴向尺寸，有利于假腔20的血栓化。The anchoringpart 110 is used to be arranged in the lumen of thestent 200, that is, the anchoringpart 110 is kept in thetrue lumen 10 of the aorta. In this case, the occluder should be ensured. On the premise that the 100 can be effectively connected to the bracket 200 (that is, the first spring coil assembly cannot pass through the hole on the bracket 200), the size of the first spring coil assembly is reduced as much as possible, To minimize the possibility of thrombosis. Generally, the axial dimension of the second coil assembly is greater than or equal to the axial dimension of the first coil assembly, which is favorable for thrombosis of thefalse lumen 20 .

请继续参考图2及图3，所述栓塞部120还包括促栓绒毛123，所述促栓绒毛123附着于所述第二弹簧圈组件上，以增大所述封堵器100的填充面积，促进假腔20血栓化。所述促栓绒毛123的材质可为聚对苯二甲酸乙二醇酯(PET)、聚酰胺(PA)、聚乙烯(PE)、聚丙烯(PP)、聚氨基甲酸酯(PU)或聚乳酸(PLA)等高分子材料中的至少一种。这些高分子材料被制作为300-700D的全拉伸丝(FDY)或拉伸变形丝(DTY)后再在所述第二定型丝121上缠绕两到三圈，并被所述第二弹簧圈122的相邻两圈夹紧定位，即可形成所述促栓绒毛123(即如图6所示)。在所述栓塞部120上，所述促栓绒毛123沿所述第二定型丝121的轴向间隔设置，且相邻两个促栓绒毛123之间的轴向间距为5mm-10mm。另外，每个所述促栓绒毛123的长度(所述促栓绒毛123从所述第一定型丝111上的连接点到促栓绒毛123的自由端的长度)为15mm-25mm。Please continue to refer to FIG. 2 and FIG. 3 , theplug portion 120 further includes plug-promotingfluff 123 , and the plug-promotingfluff 123 is attached to the second coil assembly to increase the filling area of theoccluder 100 , to promote thrombosis of thefalse lumen 20. The embolization-promotingfluff 123 can be made of polyethylene terephthalate (PET), polyamide (PA), polyethylene (PE), polypropylene (PP), polyurethane (PU) or At least one of polymer materials such as polylactic acid (PLA). These polymer materials are made into 300-700D fully drawn yarn (FDY) or stretched textured yarn (DTY), and then wound two to three times on thesecond setting yarn 121, and then wrapped by the second spring The plug-promotingfluff 123 can be formed by clamping and positioning two adjacent circles of the circle 122 (ie, as shown in FIG. 6 ). On theembolization portion 120 , the embolization-promotingfluffs 123 are arranged at intervals along the axial direction of thesecond shaping wire 121 , and the axial distance between two adjacent embolization-promotingfluffs 123 is 5 mm-10 mm. In addition, the length of each of the embolization fluff 123 (the length of theembolization fluff 123 from the connection point on thefirst shaping wire 111 to the free end of the embolization fluff 123 ) is 15mm-25mm.

进一步地，所述第一弹簧圈组件的强度大于所述第二弹簧圈组件的强度，以便于所述锚定部110能够提供足够的锚固性能。此处的强度指的是定型强度，即能够保持形状的能力。也就是说，第一弹簧圈组件的强度足够大以保证封堵器能够固定在支架上不会脱出。在一种可实现该目的的实施方式中， 所述第一定型丝111和所述第二定型丝121为同种材质，且所述第一定型丝111的直径大于所述第二定型丝121的直径。具体来说，所述第一定型丝111的直径可为0.008inch～0.020inch，所述第二定型丝的直径为0.005inch～0.012inch。Further, the strength of the first coil assembly is greater than the strength of the second coil assembly, so that the anchoringportion 110 can provide sufficient anchoring performance. Strength here refers to set strength, that is, the ability to retain shape. That is to say, the strength of the first spring coil assembly is large enough to ensure that the occluder can be fixed on the bracket and will not come out. In an embodiment that can achieve this purpose, thefirst shaping wire 111 and thesecond shaping wire 121 are made of the same material, and the diameter of thefirst shaping wire 111 is larger than that of the second shaping wire The diameter of thewire 121. Specifically, the diameter of thefirst shaping wire 111 may be 0.008 inch˜0.020 inch, and the diameter of the second shaping wire may be 0.005 inch˜0.012 inch.

请继续参考图2及图3，所述封堵器100还包括显影元件130，所述显影元件130用于对体内的所述封堵器100的所述栓塞部120和所述锚定部110进行定位。在一些实施方式中，所述显影元件130的数量可至少为一个，并设置在所述栓塞部120和所述锚定部110的分界区，这样当所述显影元件130位于破口30处时便可以确定栓塞部120进入假腔20，而锚定部110留在所述支架200的内腔。应知晓，所述分界区可以是所述栓塞部120与所述锚定部110的分界线处，也可以具有一定的宽度。在另一些实现方式中，所述显影元件130的数量至少为两个，至少两个所述显影元件130分别设置在所述栓塞部120和所述锚定部110上。当然，所述显影元件130在三个以上时，可分别设置在所述锚定部110、所述栓塞部120及两者的分界区。Please continue to refer to FIG. 2 and FIG. 3 , theoccluder 100 further includes a developingelement 130 , and the developingelement 130 is used for the pluggingpart 120 and the anchoringpart 110 of theoccluder 100 in the body. to locate. In some embodiments, the number of the developingelement 130 can be at least one, and is disposed at the boundary area between theplug portion 120 and theanchor portion 110 , so that when the developingelement 130 is located at thebreach 30 It can be determined that theplug portion 120 enters thefalse lumen 20 while the anchoringportion 110 remains in the inner lumen of thestent 200 . It should be known that the boundary area may be the boundary line between theplug portion 120 and theanchor portion 110, or may have a certain width. In other implementations, the number of the developingelements 130 is at least two, and the at least two developingelements 130 are respectively disposed on theplug portion 120 and theanchor portion 110 . Of course, when there are more than three developingelements 130 , they may be respectively disposed in the anchoringportion 110 , theplug portion 120 and the boundary between the two.

接下去介绍所述第一弹簧圈组件和所述第二弹簧圈组件的具体形状及制作过程。可理解的是，所述第一定型丝111和所述第二定型丝121可以分体式成型后通过焊接的方式连接于一体，也可以直接一体成型；同样地，所述第一弹簧圈112和所述第二弹簧圈122可以分体成型，也可以直接一体成型，本发明实施例对此不作限定。Next, the specific shapes and manufacturing processes of the first spring coil assembly and the second spring coil assembly are introduced. It can be understood that thefirst setting wire 111 and thesecond setting wire 121 can be integrally formed by welding after being formed separately, or can be directly integrally formed; similarly, thefirst spring coil 112 Thesecond spring coil 122 and thesecond spring coil 122 may be separately formed, or may be directly integrally formed, which is not limited in the embodiment of the present invention.

请参考图7，所述第一定型丝111可采用形状记忆合金例如镍钛合金、铜镍合金、铜锌合金，钴铬合金或不锈钢合金等制作而成。所述第一定型丝111经盘绕而呈所述第一预定形状，并通过热处理以使所述第一定型丝111在自然状态下具有所述第一预定形状。当所述第一定型丝111受到外力作用时，所述第一定型丝111的形状可被改变(例如被抻直)，但当所述外力被取消时，所述第一定型丝111能够恢复至所述第一预定形状。Referring to FIG. 7 , thefirst shaping wire 111 can be made of shape memory alloys such as nickel-titanium alloys, copper-nickel alloys, copper-zinc alloys, cobalt-chromium alloys or stainless steel alloys. Thefirst shaping wire 111 is coiled to have the first predetermined shape, and is heat-treated to make thefirst shaping wire 111 have the first predetermined shape in a natural state. When thefirst sizing wire 111 is subjected to an external force, the shape of thefirst sizing wire 111 can be changed (for example, stretched), but when the external force is cancelled, thefirst sizing wire 111 111 can be restored to the first predetermined shape.

优选地，所述第一定型丝111盘绕成连续且光滑的曲线结构，从而在最终形成所述第一弹簧圈组件时，所述第一弹簧圈组件没有尖锐的折角，避免在植入血管时对血管造成剐蹭而出现二次伤害。曲线结构的具体形态根据所 述第一预定形状确定。本发明实施例中，所述第一预定形状可以是锥形(如图8所示)、螺旋形、球形、六面体形或其他任意合适的形状。应理解的是，当所述第一预定形状为锥形时，所述锥形的横截面沿远离所述栓塞部120的方向逐渐增大。此外，此处所述的锥形、球形、六面体型包括几何意义上的锥形、球形、六面体形，也包括大体呈锥形、球形、六面体形的情形。Preferably, thefirst shaping wire 111 is coiled into a continuous and smooth curvilinear structure, so that when the first coil assembly is finally formed, the first coil assembly does not have sharp corners, which avoids the need for implantation in blood vessels. When the blood vessels are scratched and the secondary damage occurs. The specific shape of the curved structure is determined according to the first predetermined shape. In this embodiment of the present invention, the first predetermined shape may be a cone (as shown in FIG. 8 ), a spiral, a sphere, a hexahedron, or any other suitable shape. It should be understood that, when the first predetermined shape is a cone, the cross section of the cone gradually increases in a direction away from theplug portion 120 . In addition, the conical, spherical, and hexahedral shapes described herein include the geometrical conical, spherical, and hexahedral shapes, and also include the cases of generally conical, spherical, and hexahedral shapes.

所述第一弹簧圈112由金属丝沿一芯轴螺旋盘绕呈弹簧结构，然后对所述金属丝的两端加热定型而成(如图9所示)。所述第一弹簧圈112可采用镍钛丝、铂钨丝、不锈钢丝等制作。Thefirst spring coil 112 is formed by spirally coiling a metal wire along a mandrel to form a spring structure, and then heating and shaping both ends of the metal wire (as shown in FIG. 9 ). Thefirst spring coil 112 can be made of nickel-titanium wire, platinum-tungsten wire, stainless steel wire or the like.

然后，向所述第一定型丝111施加外力，并将处于所述第一预定形状的所述第一定型丝111抻直，再将所述第一弹簧圈112套装在所述第一定型丝111上。取消所述外力后，所述第一定型丝111在其自身的回弹力的作用下恢复至所述第一预定形状，从而得到具有所述第一预定形状的所述第一弹簧圈组件(当所述第一预定形状为锥形时，第一弹簧圈组件的结构如图10所示)。优选地，所述第一弹簧圈112的两端还分别与所述第一定型丝111连接，以防止所述封堵器100在释放过程中出现所述第一弹簧圈112解旋的现象。Then, an external force is applied to thefirst sizing wire 111, thefirst sizing wire 111 in the first predetermined shape is stretched, and thefirst spring coil 112 is sleeved on the first on thesetting wire 111. After the external force is cancelled, thefirst shaping wire 111 is restored to the first predetermined shape under the action of its own resilience, thereby obtaining the first spring coil assembly ( When the first predetermined shape is a cone, the structure of the first spring coil assembly is shown in FIG. 10 ). Preferably, both ends of thefirst spring coil 112 are respectively connected with thefirst shaping wire 111 to prevent thefirst spring coil 112 from untwisting during the release process of theoccluder 100 .

以上以所述第一弹簧圈组件的具体形状和制作过程为例进行介绍，但本领域技术人员可对其进行修改，以使其适应于第二弹簧圈组件的具体形状和制作过程。也就是说，所述第二定型丝121的材质可以所述第一定型丝111的材质相同，且所述第二预定形状也可以是螺旋形、锥形、球形、六面体形或其他任意合适的形状。确定所述第二预定形状后，将所述第二定型丝121盘绕呈所述第二预定形状，然后将第二弹簧圈122套装于已抻直的所述第二定型丝121上，当所述第二定型丝121恢复至所述第二预定形状时，即得到处于所述第二预定形状的所述第二弹簧圈组件。同样地，当所述第二预定形状为锥形时，所述锥形的横截面沿远离所述锚定部110的方向逐渐增大。The specific shape and manufacturing process of the first spring coil assembly are described above as an example, but those skilled in the art can modify it to adapt to the specific shape and manufacturing process of the second coil assembly. That is to say, the material of thesecond shaping wire 121 may be the same as that of thefirst shaping wire 111 , and the second predetermined shape may also be a spiral, a cone, a sphere, a hexahedron, or any other suitable shape. shape. After the second predetermined shape is determined, thesecond setting wire 121 is coiled to form the second predetermined shape, and then thesecond spring coil 122 is set on the stretchedsecond setting wire 121. When thesecond setting wire 121 is restored to the second predetermined shape, the second spring coil assembly in the second predetermined shape is obtained. Likewise, when the second predetermined shape is a cone, the cross section of the cone gradually increases in a direction away from theanchor portion 110 .

此外，对于所述第一定型丝111和所述第二定型丝121一体成型，以及所述第一弹簧圈112和所述第二弹簧圈122一体成型的情形，将一体式的定型丝(包括所述第一定型丝111和所述第二定型丝121)的一部分盘绕呈所述第一预定形状，另一部分盘绕成所述第二预定形状后，将定型丝整体抻直后， 再将一体式的弹簧圈(包括第一弹簧圈112和第二弹簧圈122)套装在定型丝上，取消施加在所述定型丝上的作用力以使所述定型丝恢复成初始形状后，同时得到所述第一弹簧圈组件和所述第二弹簧圈组件。In addition, for the case where thefirst setting wire 111 and thesecond setting wire 121 are integrally formed, and thefirst spring coil 112 and thesecond spring coil 122 are integrally formed, the integral setting wire ( A part including thefirst shaping wire 111 and the second shaping wire 121) is coiled into the first predetermined shape, and the other part is coiled into the second predetermined shape, after the shaping wire is stretched as a whole, and then Set the integral spring coil (including thefirst spring coil 112 and the second spring coil 122) on the setting wire, cancel the force exerted on the setting wire to restore the setting wire to the original shape, and at the same time The first coil assembly and the second coil assembly are obtained.

请返回参考图4及图5，本发明实施例还提供了一种封堵系统，包括前述的封堵器100和支架200，所述支架200通常为金属裸支架，其上具有孔隙，所述封堵器100之栓塞部120用于穿过所述孔隙并伸出所述支架200的外部，进而从主动脉夹层的破口30处伸入假腔20并封堵破口30，同时所述锚定部110布置在所述支架200的内腔中，并使所述封堵器100连接于所述支架200上，以避免所述封堵器100移位而影响封堵效果。Referring back to FIG. 4 and FIG. 5 , an embodiment of the present invention further provides an occlusion system, including theaforementioned occluder 100 and astent 200 . Thestent 200 is usually a bare metal stent with pores thereon. Theembolization part 120 of theoccluder 100 is used to pass through the hole and extend out of thestent 200, so as to extend into thefalse lumen 20 from thebreak 30 of the aortic dissection and block thebreak 30, while theThe anchoring portion 110 is arranged in the inner cavity of thestent 200 and connects theoccluder 100 to thestent 200 to prevent theoccluder 100 from being displaced and affecting the occlusion effect.

在进行主动脉夹层的治疗时，首先将所述支架200输送并释放在主动脉的真腔10内。然后再利用一导入装置将所述封堵器100植入血管。所述导入装置在输送所述封堵器100的过程中，所述第一弹簧圈组件和所述第二弹簧圈组件均被抻直。当所述导入装置的远端穿过所述支架200的孔隙及主动脉夹层的破口30并进入假腔20内时，根据所述显影元件130的显示确定所述栓塞部120已进入假腔20，且锚定部110保持在所述支架200的内腔中时，可开始释放所述封堵器100。释放完成后，所述栓塞部120保持在假腔20内，且所述第二弹簧圈组件盘缩在破口30处以封堵破口，所述锚定部110的所述第一弹簧圈组件盘缩并被所述支架200的孔隙边缘的支架棱阻挡而保持在所述支架200的内腔中。During the treatment of aortic dissection, thestent 200 is firstly delivered and released in thetrue lumen 10 of the aorta. Theoccluder 100 is then implanted into the blood vessel using an introduction device. During the process of delivering theoccluder 100 by the introduction device, both the first coil assembly and the second coil assembly are stretched. When the distal end of the introduction device passes through the hole of thestent 200 and the rupture of theaortic dissection 30 and enters thefalse lumen 20, it is determined according to the display of theimaging element 130 that theembolic part 120 has entered thefalse lumen 20, and when theanchor portion 110 remains in the lumen of thestent 200, theoccluder 100 can be released. After the release is completed, theplug portion 120 remains in thefalse cavity 20, and the second coil assembly is coiled at thebreach 30 to seal the breach, and the first coil assembly of theanchor portion 110 Coiled and held in the lumen of thestent 200 by the stent ribs at the aperture edges of thestent 200 .

虽然本发明披露如上，但并不局限于此。本领域的技术人员可以对本发明进行各种改动和变型而不脱离本发明的精神和范围。这样，倘若本发明的这些修改和变型属于本发明权利要求及其等同技术的范围之内，则本发明也意图包含这些改动和变型在内。Although the present invention is disclosed above, it is not limited thereto. Various modifications and variations can be made in the present invention by those skilled in the art without departing from the spirit and scope of the invention. Thus, provided that these modifications and variations of the present invention fall within the scope of the claims of the present invention and their equivalents, the present invention is also intended to include these modifications and variations.

Claims (11)

Translated fromChinese

一种封堵器，其特征在于，包括轴向连接的锚定部和栓塞部，所述锚定部包括第一弹簧圈组件，所述栓塞部包括第二弹簧圈组件。An occluder is characterized in that it comprises an axially connected anchor part and a plug part, the anchor part includes a first spring coil assembly, and the plug part includes a second spring coil assembly.根据权利要求1所述的封堵器，其特征在于，所述第一弹簧圈组件包括第一定型丝和第一弹簧圈，所述第一定型丝为具有回弹性的金属丝并被配置为具有第一预定形状，所述第一弹簧圈套装在所述第一定型丝上并使所述第一弹簧圈组件形成所述第一预定形状；和/或，The occluder according to claim 1, wherein the first spring coil assembly comprises a first setting wire and a first spring coil, and the first setting wire is a metal wire with resilience and is configured to have a first predetermined shape, the first spring coil is sleeved on the first shaping wire and the first spring coil assembly is formed into the first predetermined shape; and/or,所述第二弹簧圈组件包括第二定型丝和第二弹簧圈，所述第二定型丝为具有回弹性的金属丝并被配置为具有第二预定形状，所述第二弹簧圈套装在所述第二定型丝上并使所述第二弹簧圈组件形成所述第二预定形状。The second spring coil assembly includes a second setting wire and a second spring coil, the second setting wire is a metal wire with resilience and is configured to have a second predetermined shape, and the second spring coil is sleeved at the place. the second setting wire and the second spring coil assembly to form the second predetermined shape.根据权利要求1或2所述的封堵器，其特征在于，所述封堵器还包括显影元件，所述显影元件布置在所述锚定部与所述栓塞部的分界区；和/或，所述显影元件布置在所述锚定部及所述栓塞部上。The occluder according to claim 1 or 2, characterized in that, the occluder further comprises a developing element, and the developing element is arranged in a boundary area between the anchor portion and the plug portion; and/or , the developing element is arranged on the anchor portion and the plug portion.根据权利要求1或2所述的封堵器，其特征在于，所述第一弹簧圈组件的轴向尺寸小于或等于所述第二弹簧圈组件的轴向尺寸。The occluder according to claim 1 or 2, wherein the axial dimension of the first coil assembly is smaller than or equal to the axial dimension of the second coil assembly.根据权利要求2所述的封堵器，其特征在于，所述第一弹簧圈组件的强度大于所述第二弹簧圈组件的强度。The occluder according to claim 2, wherein the strength of the first coil assembly is greater than the strength of the second coil assembly.根据权利要求5所述的封堵器，其特征在于，所述第一定型丝和所述第二定型丝为同种材料，且所述第一定型丝的直径大于所述第二定型丝的直径以使所述第一弹簧圈组件的强度大于所述第二弹簧圈组件的强度。The occluder according to claim 5, wherein the first shaping wire and the second shaping wire are made of the same material, and the diameter of the first shaping wire is larger than that of the second shaping wire The diameter of the wire is such that the strength of the first coil assembly is greater than the strength of the second coil assembly.根据权利要求6所述的封堵器，其特征在于，所述第一定型丝的直径为0.008inch～0.020inch，所述第二定型丝的直径为0.005inch～0.012inch。The occluder according to claim 6, wherein the diameter of the first shaping wire is 0.008 inch to 0.020 inch, and the diameter of the second shaping wire is 0.005 inch to 0.012 inch.根据权利要求2所述的封堵器，其特征在于，所述第一预定形状为螺旋线形、锥形、球形或六面体型中的任一种；和/或，所述第二预定形状为螺旋线形、锥形、球形或六面体形中的任一种。The occluder according to claim 2, wherein the first predetermined shape is any one of a helix, a cone, a sphere or a hexahedron; and/or the second predetermined shape is a helix Any of linear, conical, spherical or hexahedral shapes.根据权利要求8所述的封堵器，其特征在于，当所述第一预定形状为锥形时，所述锥形的横截面沿远离所述栓塞部的方向逐渐增大；和/或，当所 述第二预定形状为锥形时，所述锥形的横截面沿远离所述锚定部的方向逐渐增大。The occluder according to claim 8, wherein when the first predetermined shape is a cone, the cross section of the cone gradually increases in a direction away from the plug portion; and/or, When the second predetermined shape is a cone, the cross section of the cone gradually increases in a direction away from the anchor portion.根据权利要求1所述的封堵器，其特征在于，所述栓塞部还包括促栓绒毛，所述促栓绒毛附着于所述第二弹簧圈组件上。The occluder according to claim 1, wherein the plug portion further comprises plug-promoting fluff, and the plug-promoting fluff is attached to the second coil assembly.一种封堵系统，其特征在于，包括支架和至少一个如权利要求1-10中任一项所述的封堵器，所述栓塞部用于穿过所述支架上的孔隙并伸出所述支架的外部，所述锚定部用于设置在所述支架的内腔中并使所述封堵器连接于所述支架上。An occlusion system, characterized in that it comprises a stent and at least one occluder according to any one of claims 1-10, wherein the plug portion is used to pass through a hole on the stent and protrude out of the occluder. Outside the stent, the anchoring part is used to be arranged in the inner cavity of the stent and connect the occluder to the stent.

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