WO2022151891A1 - 一种具有内收式翼展裙边的球囊扩张式介入瓣膜支架 - Google Patents

一种具有内收式翼展裙边的球囊扩张式介入瓣膜支架 Download PDF

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WO2022151891A1
WO2022151891A1 PCT/CN2021/137952 CN2021137952W WO2022151891A1 WO 2022151891 A1 WO2022151891 A1 WO 2022151891A1 CN 2021137952 W CN2021137952 W CN 2021137952W WO 2022151891 A1 WO2022151891 A1 WO 2022151891A1
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Prior art keywords
skirt
wingspan
balloon
stent
pulling
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PCT/CN2021/137952
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English (en)
French (fr)
Inventor
马琛明
顾佳佳
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南京圣德医疗科技有限公司
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Application filed by 南京圣德医疗科技有限公司 filed Critical 南京圣德医疗科技有限公司
Priority to EP21919080.8A priority Critical patent/EP4279029A1/en
Priority to US18/264,176 priority patent/US20240099833A1/en
Publication of WO2022151891A1 publication Critical patent/WO2022151891A1/zh

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    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/02—Prostheses implantable into the body
    • A61F2/24—Heart valves ; Vascular valves, e.g. venous valves; Heart implants, e.g. passive devices for improving the function of the native valve or the heart muscle; Transmyocardial revascularisation [TMR] devices; Valves implantable in the body
    • A61F2/2427—Devices for manipulating or deploying heart valves during implantation
    • A61F2/243—Deployment by mechanical expansion
    • A61F2/2433—Deployment by mechanical expansion using balloon catheter
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/02—Prostheses implantable into the body
    • A61F2/24—Heart valves ; Vascular valves, e.g. venous valves; Heart implants, e.g. passive devices for improving the function of the native valve or the heart muscle; Transmyocardial revascularisation [TMR] devices; Valves implantable in the body
    • A61F2/2412—Heart valves ; Vascular valves, e.g. venous valves; Heart implants, e.g. passive devices for improving the function of the native valve or the heart muscle; Transmyocardial revascularisation [TMR] devices; Valves implantable in the body with soft flexible valve members, e.g. tissue valves shaped like natural valves
    • A61F2/2418—Scaffolds therefor, e.g. support stents
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2220/00—Fixations or connections for prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof
    • A61F2220/0025—Connections or couplings between prosthetic parts, e.g. between modular parts; Connecting elements
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2250/00—Special features of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof
    • A61F2250/0058—Additional features; Implant or prostheses properties not otherwise provided for
    • A61F2250/0069—Sealing means

Definitions

  • the invention belongs to the field of medical devices, and in particular relates to a balloon-expandable interventional valve stent with an adducted wingspan skirt, which can be applied to the positions of aortic valve, pulmonary valve, mitral valve and tricuspid valve and Scenarios such as damage to the middle valve of the biological valve.
  • PVL Paravalvular leak
  • the existing balloon-expandable interventional valve is usually provided with a skirt on the outside of the inflow channel, such as the artificial valve structure disclosed in the patent document CN108430394A.
  • a skirt on the outside of the inflow channel, such as the artificial valve structure disclosed in the patent document CN108430394A.
  • Such a structural design is based on years of clinical experience.
  • the existing valve structure still has problems. Since the size of the valve delivery system cannot be too large, the skirt cannot be unrestrictedly thickened, so the effect of preventing paravalvular leakage is limited. Interventional valves that prevent paravalvular leaks given the size of the delivery system.
  • an object of the present invention is to provide a balloon-expandable interventional valve stent with a retracted wingspan skirt.
  • a retractable wingspan skirt is arranged on the outflow channel of the stent, and the wingspan skirt can be extended radially outward from the stent to cover and seal paravalvular leakage, thereby preventing the occurrence of paravalvular leakage. adverse consequences.
  • the present invention provides a balloon-expandable interventional valve stent with retractable wingspan skirt, comprising a stent body, valve leaflets and wingspan skirt, wherein the stent body includes an inflow channel located at a lower portion and an outflow channel located at an upper portion.
  • the wingspan skirt is arranged on the outside of the outflow channel, the side of the wingspan skirt close to the middle of the bracket main body is fixedly connected to the bracket, and the other parts of the wingspan skirt are not connected to the bracket body.
  • the surface of the wingspan skirt is attached to the surface of the bracket body; the inflow channel side of the bracket body is also provided with a skirt; the wingspan skirt is connected with a pulling suture, so One side of the pulling suture is connected to the wingspan skirt, and one side is connected to the skirt on the inflow channel side, and the pulling suture is reciprocatingly connected to the wingspan skirt and the inflow channel side.
  • the two ends of the stent body are opened first, the middle part of the stent body is opened later, and when the stent body located on the inflow channel side is opened, it is located on the inflow channel side
  • the skirt of the wing is expanded accordingly, and the pulling suture connected to the skirt on the inflow tract side is gradually tightened along the circumferential direction under the action of the balloon expansion force, so that the wingspan skirt on the outflow tract side is located in the wingspan skirt.
  • the tensioning suture is tensioned, and the tensioned pulling suture causes the spanwise skirt to be folded to the outside of the inflow channel along the axial direction of the stent body, forming in the radial direction of the stent body A portion that protrudes outwards, thereby covering or sealing a paravalvular leak.
  • a plurality of circular holes are evenly arranged at the edge position of the wingspan skirt near the outflow tract side, and the number of the circular holes is an even number.
  • the pulling suture is in the shape of a plurality of continuous "ji" characters as a whole, and a plurality of connection points are arranged at intervals on the skirt on the side of the inflow channel to connect the pulling suture, so The pulling suture passes through the connecting points and the round holes in the order of "connection point-circular hole-circular hole-connection point".
  • the wingspan skirt is folded to the outside of the inflow channel along the axial direction of the bracket.
  • the number of the pulling sutures is 1, 2, 3, 4, 6 or 12, preferably 1, which continuously runs through the round hole in the wingspan skirt and the inflow tract side. on multiple attachment points of the skirt.
  • the two or more pulling sutures when there are more than two pulling sutures, have equal lengths and are connected end to end at the connection point of the skirt on the inflow channel side, Together they cover the entire circumference of the spanwise skirt.
  • both the wingspan skirt and the pulling suture are made of flexible non-metallic materials.
  • the pulling suture is made of polymer material, preferably polyglycolic acid, polylactic acid or polydioxanone.
  • the advantage of the present invention is that the structure of the outflow channel is fully utilized, and the available wing span skirt structure is increased without increasing the diameter of the conveying system.
  • the spanwise skirt can provide a better occlusion effect than the current state of the art.
  • the additional structure will not increase the damage to the heart.
  • FIG. 1 is a schematic diagram of a crimping state of a balloon-expandable interventional valve stent according to an embodiment of the present invention
  • FIG. 2 is a schematic diagram of an expansion process of a balloon-expandable interventional valve stent according to an embodiment of the present invention
  • FIG. 3 is a schematic diagram of an expanded state of a balloon-expandable interventional valve stent according to an embodiment of the present invention
  • FIG. 4 is a schematic diagram of a pulling suture of a balloon-expandable interventional valve stent according to an embodiment of the present invention
  • FIG. 5 is a front view of the effect diagram of the balloon-expandable interventional valve stent of the present invention.
  • FIG. 6 is a top view of the effect view of the balloon-expandable interventional valve stent of the present invention.
  • a balloon-expandable interventional valve stent includes a stent body 1, valve leaflets (not shown) and a wingspan skirt 2.
  • the stent body 1 includes an inflow channel 3 located at the lower part and an inflow channel 3 located at the upper part.
  • Outflow channel 4 the wingspan skirt 2 is arranged on the outside of the outflow channel 4, the side edge of the wingspan skirt 2 close to the middle of the bracket main body 1 is fixedly connected to the bracket main body 1, and the other parts are not fixed.
  • the surface is attached to the surface of the holder body 1 .
  • a number of circular holes 8 are evenly arranged on the wingspan skirt 2 near the side edge of the outflow channel, and the number of the circular holes is an even number.
  • the inflow channel side of the stent body 1 is also provided with a skirt (not shown in the figure), and a plurality of connection points 6 are arranged at intervals on the skirt on the inflow channel side to connect the pulling sutures 5 .
  • the pulling suture 5 is in the shape of a plurality of consecutive "ji" characters, and passes through each connection point 6 and the circular hole 8 in sequence in the order of "connection point-circular hole-circular hole-connection point".
  • the above two or more pulling sutures 5 have equal lengths to each other, and are connected end to end at the connection point 6, covering the wingspan skirt 2 together. the entire circumference.
  • the two ends of the stent body 1 are opened first, and the middle part of the stent body 1 is opened later.
  • the skirt on the inflow channel side is expanded accordingly, and is connected to the inflow channel side.
  • the pulling suture 5 in the skirt on the tract side is gradually tightened along the circumferential direction under the action of the balloon expansion force, so that the pulling suture 5 in the wingspan skirt 2 on the outflow tract side is tensioned, resulting in
  • the wingspan skirt 2 on the outflow channel side is folded to the outside of the inflow channel along the axial direction of the stent body 1, and the wingspan skirt in the folded state presents an edge under the combined action of the balloon expansion force and the tension force of the pulling suture.
  • the radially outwardly protruding portion of the stent body 1 , and the radially outwardly protruding skirt portion can cover and seal the perivalvular leakage, and integrally constitute the retracted spanwise skirt 2 .
  • the wingspan skirt 2 is made of flexible non-metallic materials, and the pulling suture 5 can be made of polymer materials such as polyglycolic acid, polylactic acid or polydioxanone.
  • the technical solution of the present invention makes full use of the structure of the outflow channel, and increases the available wing span skirt structure without increasing the diameter of the conveying system.
  • the wingspan skirt structure of the present invention can greatly improve the sealing effect of paravalvular leakage. And because of the use of flexible non-metallic materials, the additional structure will not increase the damage to the heart.

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  • Health & Medical Sciences (AREA)
  • Cardiology (AREA)
  • Engineering & Computer Science (AREA)
  • Biomedical Technology (AREA)
  • Vascular Medicine (AREA)
  • Transplantation (AREA)
  • Oral & Maxillofacial Surgery (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Mechanical Engineering (AREA)
  • Prostheses (AREA)
  • Media Introduction/Drainage Providing Device (AREA)

Abstract

一种具有内收式翼展裙边（2）的球囊扩张式介入瓣膜支架，包括支架主体（1）、瓣叶和翼展裙边（2），翼展裙边（2）设置在流出道（4）外侧，在翼展裙边（2）靠近流出道（4）侧的边缘位置均匀设置若干个圆孔（8），在翼展裙边（2）上连接有牵拉缝线（5），当球囊（7）扩张打开时，连接于流入道（3）侧的裙边内的牵拉缝线（5）在球囊（7）扩张力的作用下沿着圆周方向逐渐拉紧，致使翼展裙边（2）沿支架的轴线方向向流入道（3）外侧翻折，形成在支架主体（1）的径向方向上向外突出的部分，从而覆盖或封堵瓣周漏。在不增加输送***直径的前提下，增加了可以利用的翼展裙边（2）结构，大大改善了瓣周漏的封堵效果。

Description

一种具有内收式翼展裙边的球囊扩张式介入瓣膜支架
本申请要求2021年1月14日向中国国家知识产权局提交的，专利申请号为202110051090.7，发明名称为“一种具有内收式翼展裙边的球囊扩张式介入瓣膜支架”在先申请的优先权。该申请的全文通过引用的方式结合于本申请中。
技术领域
本发明属于医疗器械领域，特别是涉及一种具有内收式翼展裙边的球囊扩张式介入瓣膜支架，其可应用在主动脉瓣、肺动脉瓣、二尖瓣和三尖瓣瓣膜位置以及损毁生物瓣膜瓣中瓣等场景。
背景技术
瓣周漏(PVL)，即在人工瓣膜和周围组织间形成漏口，是在所有心脏瓣膜手术中均常见的的严重并发症。特别在目前日趋主流的经导管瓣膜治疗中发生率极高。多项研究已经表明，手术后瓣周漏直接与患者的恢复程度、再次手术率、再次住院率、早中长期死亡率相关。一项多个国际研究荟萃的结果显示，经导管主动脉瓣膜介入手术后只有6-59％患者没有发生瓣周漏。这其中的原因除了不能切除患者原来的退化、衰败、损毁的瓣膜，患者自身的解剖结构，诸如瓣环平面非圆形等因素等不可避免的原因外，还与目前的经导管瓣膜介入手术器材的设计特点有很大关系。随着经导管技术在全世界的普及，越来越多的患者，并且越来越年轻的患者将会选择经导管瓣膜手术接受治疗，新型经导管瓣膜介入手术器材的出现势在必行。
目前现有的球囊扩张式介入瓣膜，通常在流入道的外侧设置裙边，如专利 文献CN108430394A中所公开的人造瓣膜结构，这样的结构设计是基于多年的临床使用经验，认为可以通过增加与心脏瓣环平面的接触面积来改善瓣周漏。但是现有的瓣膜结构仍然存在问题，由于瓣膜输送***的尺寸不可能太大，导致裙边不能无限制增厚，所以防止瓣周漏的效果受到了限制，因此需要一种能够在不增加瓣膜输送***尺寸的条件下防止瓣周漏的介入瓣膜。
发明内容
因此本发明的目的在于提供一种具有内收式翼展裙边的球囊扩张式介入瓣膜支架。它通过特有的设计，在支架的流出道设置内收式翼展裙边，翼展裙边能够由支架径向向外伸出，覆盖和封堵瓣周漏，从而防止由于瓣周漏而产生的不良后果。
本发明通过如下技术方案实现：
本发明提供一种具有内收式翼展裙边的球囊扩张式介入瓣膜支架，包括支架主体、瓣叶和翼展裙边，所述支架主体包括位于下部的流入道和位于上部的流出道，所述翼展裙边设置在流出道外侧，所述翼展裙边靠近支架主体中部的侧边固定连接在所述支架上，所述翼展裙边的其他部分均不与所述支架主体固定连接，所述翼展裙边表面贴附在所述支架主体表面上；所述支架主体的流入道侧也设置有裙边；在所述翼展裙边上连接有牵拉缝线，所述牵拉缝线的一侧连接所述翼展裙边，一侧连接流入道侧的所述裙边，所述牵拉缝线往复多次连接在所述翼展裙边和流入道侧的所述裙边之间；当球囊扩张打开时，所述支架主体的两端先打开，所述支架主体的中部随后打开，当位于流入道侧的所述支架主体打开时，位于流入道侧的裙边随之展开，连接于流入道侧的裙边内的牵拉缝线在球囊扩张力的作用下沿着圆周方向逐渐拉紧，使得位于流出道侧的所述翼展裙边内的牵拉缝线张紧，所述张紧的牵拉缝线致使所述翼展裙边沿所述支架主体的轴线方向向流入道的外侧翻折，形成在所述支架主体的径向方向上向外突出的部分，从而覆盖或封堵瓣周漏。
根据本发明所述的瓣膜支架，在所述翼展裙边靠近流出道侧的边缘位置均匀设置若干个圆孔，所述圆孔的数量为偶数个。
根据本发明所述的瓣膜支架，所述牵拉缝线整体呈连续的多个“几”字形，在流入道侧的裙边上间隔设置多个连接点以连接所述牵拉缝线，所述牵拉缝线按照“连接点-圆孔-圆孔-连接点”的顺序顺次通过所述各连接点和所述各圆孔，当所述牵拉缝线张紧时，流出道侧的所述翼展裙边沿支架的轴线方向向流入道外侧翻折。
根据本发明所述的瓣膜支架，所述牵拉缝线为1、2、3、4、6或12条，优选为1条，连续贯穿于翼展裙边内的圆孔和流入道侧的裙边的多个连接点上。
根据本发明所述的瓣膜支架，当牵拉缝线有2条以上时，上述2条以上的牵拉缝线彼此具有相等的长度，在流入道侧的裙边的连接点处首尾相继连接，共同覆盖所述翼展裙边的整个圆周。
根据本发明所述的瓣膜支架，所述翼展裙边和所述牵拉缝线均由柔性非金属材料制成。
根据本发明所述的瓣膜支架，所述牵拉缝线由高分子材料制成，优选为聚乙醇酸、聚乳酸或聚对二氧环己酮。
本发明的有益效果：
本发明的优点是，充分利用了流出道的结构，在不增加输送***直径的前提下，增加了可以利用的翼展裙边结构。对于瓣周漏，比如非椭圆形的心脏瓣环，翼展裙边可以相对于目前现有技术提供更优的封堵效果。并且由于使用的是柔性的非金属材料，附加结构不会增加对心脏的损伤。
附图说明
图1本发明实施例的球囊扩张式介入瓣膜支架的压握状态的示意图；
图2本发明实施例的球囊扩张式介入瓣膜支架的扩张过程的示意图；
图3本发明实施例的球囊扩张式介入瓣膜支架的扩张状态的示意图；
图4本发明实施例的球囊扩张式介入瓣膜支架的牵拉缝线的示意图；
图5本发明的球囊扩张式介入瓣膜支架的效果图的主视图；
图6本发明的球囊扩张式介入瓣膜支架的效果图的俯视图。
具体实施方式
下面结合具体实施例，进一步阐述本发明。应理解，实施例仅用于说明本发明而不用于限制本发明的保护范围。此外，应理解，在阅读了本发明所公开的内容之后，本领域技术人员可以对本发明作各种改动或修改，这些等价形式同样落于本发明所限定的保护范围之内。
如图1-3所示，一种球囊扩张式介入瓣膜支架包括支架主体1、瓣叶(未图示)和翼展裙边2，支架主体1包括位于下部的流入道3和位于上部的流出道4，翼展裙边2设置在流出道4外侧，翼展裙边2靠近支架主体1的中部的侧边固定连接在支架主体1上，其他部分均不固定，翼展裙边2的表面贴附在支架主体1的表面上。在翼展裙边2靠近流出道侧边缘位置均匀设置若干个圆孔8，所述圆孔的数量为偶数个，在翼展裙边2上连接有牵拉缝线5。
支架主体1的流入道侧也设置有裙边(图中未示出)，在流入道侧的裙边上间隔设置多个连接点6以连接牵拉缝线5。牵拉缝线5呈连续多个“几”字形，按照“连接点-圆孔-圆孔-连接点”的顺序顺次通过各连接点6和圆孔8。牵拉缝线可以有若干条，例如1、2、3、4、6或12条，优选为1条，连续贯穿于翼展裙边内的圆孔8和流入道侧的外裙边的多个连接点6上，当牵拉缝线有2条以上时，上述2条以上的牵拉缝线5彼此具有相等的长度，在连接点6处首尾相继连接，共同覆盖翼展裙边2的整个圆周。
当球囊7扩张打开时，支架主体1两端先打开，支架主体1的中部随后打开，当位于流入道侧的支架主体1打开时，位于流入道侧的裙边随之展开，连接于流入道侧的裙边内的牵拉缝线5在球囊扩张力的作用下沿着圆周方向逐渐 拉紧，使得位于流出道侧的翼展裙边2内的牵拉缝线5张紧，致使流出道侧的翼展裙边2沿支架主体1的轴线方向向流入道外侧翻折，翻折状态的翼展裙边在球囊扩张力和牵拉缝线张紧力的共同作用下呈现沿支架主体1的径向方向向外的突出部分，该沿径向方向向外突出的裙边部分可以覆盖和封堵瓣周漏，整体构成内收式翼展裙边2。翼展裙边2选用柔性非金属材料制成，牵拉缝线5可以选用聚乙醇酸、聚乳酸或聚对二氧环己酮等高分子材料制成。
由图5和图6可以看出，本发明的技术方案充分利用了流出道的结构，在不增加输送***直径的前提下，增加了可以利用的翼展裙边结构。本发明的翼展裙边结构可以大大改善瓣周漏的封堵效果。并且由于使用的是柔性的非金属材料，附加结构不会增加对心脏的损伤。
以上，对本发明的实施方式进行了说明。但是，本发明不限定于上述实施方式。凡在本发明的精神和原则之内，所做的任何修改、等同替换、改进等，均应包含在本发明的保护范围之内。

Claims (7)

  1. 一种具有内收式翼展裙边的球囊扩张式介入瓣膜支架，其特征在于，包括支架主体、瓣叶和翼展裙边，所述支架主体包括位于下部的流入道和位于上部的流出道，所述翼展裙边设置在流出道外侧，所述翼展裙边靠近支架主体中部的侧边固定连接在所述支架上，所述翼展裙边的其他部分均不与所述支架主体固定连接，所述翼展裙边表面贴附在所述支架主体表面上；
    所述支架主体的流入道侧也设置有裙边；在所述翼展裙边上连接有牵拉缝线，所述牵拉缝线的一侧连接所述翼展裙边，一侧连接流入道侧的所述裙边，所述牵拉缝线往复多次连接在所述翼展裙边和流入道侧的所述裙边之间；
    当球囊扩张打开时，所述支架主体的两端先打开，所述支架主体的中部随后打开，当位于流入道侧的所述支架主体打开时，位于流入道侧的裙边随之展开，连接于流入道侧的裙边内的牵拉缝线在球囊扩张力的作用下沿着圆周方向逐渐拉紧，使得位于流出道侧的所述翼展裙边内的牵拉缝线张紧，所述张紧的牵拉缝线致使所述翼展裙边沿所述支架主体的轴线方向向流入道的外侧翻折，形成在所述支架主体的径向方向上向外突出的部分，从而覆盖或封堵瓣周漏。
  2. 根据权利要求1所述的一种具有内收式翼展裙边的球囊扩张式介入瓣膜支架，其特征在于，在所述翼展裙边靠近流出道侧的边缘位置均匀设置若干个圆孔，所述圆孔的数量为偶数个。
  3. 根据权利要求2所述的一种具有内收式翼展裙边的球囊扩张式介入瓣膜支架，其特征在于，所述牵拉缝线整体呈连续的多个“几”字形，在流入道侧的裙边上间隔设置多个连接点以连接所述牵拉缝线，所述牵拉缝线按照“连接点-圆孔-圆孔-连接点”的顺序顺次通过所述各连接点和所述各圆孔，当所述牵拉缝线张紧时，流出道侧的所述翼展裙边沿支架的轴线方向向流入道外侧翻折。
  4. 根据权利要求3所述的一种具有内收式翼展裙边的球囊扩张式介入瓣膜支架，其特征在于，所述牵拉缝线为1、2、3、4、6或12条，优选为1
    条，连续贯穿于翼展裙边内的圆孔和流入道侧的裙边的多个连接点上。
  5. 根据权利要求4所述的一种具有内收式翼展裙边的球囊扩张式介入瓣膜支架，其特征在于，当牵拉缝线有2条以上时，上述2条以上的牵拉缝线彼此具有相等的长度，在流入道侧的裙边的连接点处首尾相继连接，共同覆盖所述翼展裙边的整个圆周。
  6. 根据权利要求5所述的一种具有内收式翼展裙边的球囊扩张式介入瓣膜支架，其特征在于，所述翼展裙边和所述牵拉缝线均由柔性非金属材料制成。
  7. 根据权利要求6所述的一种具有内收式翼展裙边的球囊扩张式介入瓣膜支架，其特征在于，所述牵拉缝线由高分子材料制成，优选为聚乙醇酸、聚乳酸或聚对二氧环己酮。
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