WO2022037183A1 - 一种环缩器及其安装方法 - Google Patents

一种环缩器及其安装方法 Download PDF

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Publication number
WO2022037183A1
WO2022037183A1 PCT/CN2021/098100 CN2021098100W WO2022037183A1 WO 2022037183 A1 WO2022037183 A1 WO 2022037183A1 CN 2021098100 W CN2021098100 W CN 2021098100W WO 2022037183 A1 WO2022037183 A1 WO 2022037183A1
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WIPO (PCT)
Prior art keywords
puncture tube
pull wire
disc
push rod
hemostatic
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PCT/CN2021/098100
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English (en)
French (fr)
Inventor
戴宇峰
潘炳跃
朱玲川
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上海竑宇医疗科技有限公司
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Application filed by 上海竑宇医疗科技有限公司 filed Critical 上海竑宇医疗科技有限公司
Priority to KR1020217032865A priority Critical patent/KR20220023326A/ko
Priority to JP2021561731A priority patent/JP2022548188A/ja
Priority to US17/478,713 priority patent/US20220054268A1/en
Priority to IL287200A priority patent/IL287200A/en
Publication of WO2022037183A1 publication Critical patent/WO2022037183A1/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
    • A61F2/2478—Passive devices for improving the function of the heart muscle, i.e. devices for reshaping the external surface of the heart, e.g. bags, strips or bands
    • A61F2/2487—Devices within the heart chamber, e.g. splints

Definitions

  • the invention relates to the field of medical instruments, in particular to a ring retractor used for mitral valve operation auxiliary and an installation method thereof.
  • the mitral valve is the left atrioventricular valve, also known as the mitral valve. It is attached to the left fibrous atrioventricular annulus. It is formed by the folds of the endocardium. There are two valves. Larger, often called large valve, is the boundary mark between the inflow tract and outflow tract of the left ventricle. The one located on the posterolateral side is the posterior cusp valve. The smaller one is often called the small valve. The bottom edges are often fused with each other, and sometimes there is a small auxiliary valve between the two valves. There are many chordae tendineae connected to the papillary muscle at the valve cusp, edge and ventricular surface. When the ventricle contracts, the mitral valve tightly closes the atrioventricular orifice to prevent blood flow. Reverse flow into the left atrium, so a retractor is required for mitral regurgitation.
  • a retractor For mitral valve regurgitation treatment, a retractor needs to be used.
  • the traditional retractor is simple in structure, single in function and complicated in operation, and most of the traditional retractors are rigid structures, which increases the difficulty of the operation and prolongs the operation time. , thereby causing unnecessary harm to the patient;
  • the traditional retractor is not provided with a puncture needle device, which makes the treatment of mitral valve regurgitation more traumatic; therefore, there is an urgent need for a simple structure, elastic or Flexible ring reducer.
  • the purpose of the present invention is to provide a ring reducer and an installation method thereof to solve the above problems.
  • a ring retractor comprising a blocking sheet, a puncture tube, a push rod, a column, a hemostatic disc, a first pull wire and a second pull wire; wherein, the blocking sheet has Shape memory function, which can be pressed into a smaller size sheath, the blocking piece is fixed by a fixing ring, the fixing ring protrudes from the top of the puncture tube when it is working, and the fixing ring is connected and blocked when it is not working.
  • the sheet is compressed into the puncture tube; the lower end of the puncture tube is coaxially sleeved with the upper end of the push rod, and the lower end of the push rod is fixedly connected with the upper end of the column.
  • the discs are connected by pull wires.
  • two perforations are opened in the hemostatic disc so that the first pull wire and the second pull wire can pass through, so as to adjust the radial length of the hemostatic disc and adjust the distance between the blocking sheet and the hemostatic disc through the pull wire, So as to play the role of ring contraction.
  • an adjustment sleeve is provided on the sleeve end of the puncture tube and the push rod, the adjustment sleeve is fixedly sleeved on the outside of the puncture tube, and the push rod is slidably sleeved in the puncture tube;
  • the adjusting sleeve and the puncture tube radially penetrate two pipe walls on the same side with threaded holes, and an adjusting handle is screwed into the threaded hole, and the push rod is positioned on the puncturing pipe through the adjusting handle.
  • one end of the puncture tube is needle-shaped.
  • the blocking piece of the ring shrinker is made of an elastic nickel-titanium alloy material;
  • the fixing ring is made of a shape memory metal or a shape memory polymer material with a shape memory function.
  • the blocking sheet is a shrinkable and expandable wire braided mesh and is at least partially connected to the fixing ring, and is stored in the puncture tube in a cylindrical shape in a contracted state, and is pushed out by the push rod for puncture.
  • the expansion after the tube is a mesh umbrella-shaped woven mesh.
  • the blocking sheet is an elastic telescopic disk, and is opened on the opposite sides and the middle bottom of the elastic telescopic disk, and the first pull wire and the second pull wire pass through the bottom opening to reach the openings on both sides, Plugs are arranged at the openings on both sides, the diameter of the plugs is larger than the diameter of the two end openings, and the plugs are connected with the first pull wire and the second pull wire.
  • the transverse tube when stretched, it is concave outward from the opposite side of the middle opening to form an elastically adjustable arc structure.
  • the pulling wire is made of polymer material to make the surface smooth.
  • the hemostatic disc is a flat plate-like or sheet-like structure, and the shape can be a disc, or a star, or a square, or other irregular shapes.
  • the constituent materials include pet material, medical silica gel, peek material, or a composite material of at least two or more materials.
  • the blocking sheet is compressed into a straight line and stored in the hole of the puncture tube.
  • the puncture tube Through the puncture tube, the atrial septum is punctured at the position of the left atrium near the P2 position. Then, the puncture tube and the push rod are withdrawn in turn.
  • the first pull wire and the second pull wire are respectively inserted into the hole of the hemostatic disc, and then the hemostatic disc is attached to the surface of the heart for hemostasis.
  • the first pull wire and the second pull wire are crossed to make the atrium. It reduces the regurgitation area due to the shrinkage of the valve annulus.
  • the retractor has a simple structure, complete functions, and simple operation.
  • the occluder is made of flexible materials and has less damage to the tissue and is easy to restore tissue growth, so it achieves minimally invasive surgery. Purpose.
  • the structure of the present invention is reasonable, and the blocking sheet is installed in the puncture tube hole in a state of being compressed into a straight line.
  • the puncture tube is used to pierce the interatrial septum at the left atrium near the P position (puncture position), and the blocking sheet is pushed by the push rod to make the blocking sheet. Open the mesh tray, then the puncture tube and the push rod are withdrawn in turn. After the withdrawal, the first pull wire and the second pull wire are respectively inserted into the hole of the hemostatic tray, and then the hemostatic tray is attached to the surface of the heart to stop bleeding, and the second pull wire is passed through the first pull wire.
  • Cross-knotting reduces the atrium and valve annulus, thereby reducing the regurgitation area;
  • the surgical trauma is small and the tissue recovers quickly, so as to achieve the purpose of treating reflux.
  • FIG. 1 is a schematic diagram of the three-dimensional structure of the present invention.
  • Fig. 2 is the front view structure schematic diagram of the present invention
  • Fig. 3 is the partial enlarged structural schematic diagram of the present invention.
  • Fig. 4 is the partial enlarged structural schematic diagram of the present invention.
  • Fig. 5 is the enlarged schematic diagram of the structure at place A in Fig. 1 of the present invention.
  • Fig. 6 is the schematic diagram of the second embodiment of the blocking sheet
  • FIG. 7 is a schematic diagram of the implantation path of the device of the present invention.
  • Figure 8 is a schematic diagram of the device of the present invention after implantation.
  • Blocking sheet 2. Puncture tube; 3. Adjusting sleeve; 4. Push rod; 5. Locking stud; 6. Upright column; 7. Hemostatic disc; Pulling wire; 10. Fixing ring.
  • the present invention provides a mitral valve annulus as shown in Figs. 1-6.
  • the annulus includes a blocking sheet 1, a puncture tube 2, a push rod 4, a post 6, a hemostatic disc 7, a first pull wire 8, The second pulling wire 9 and the fixing ring 10 .
  • the blocking piece 1 has a shape memory function, and can be pressed into a sheath tube of a smaller size.
  • the blocking piece is fixed by a fixing ring 10, and the fixing ring 10 also has a shape memory function.
  • the fixing ring 10 protrudes from the top end of the puncture tube 2 when working, and in the non-working state, the fixing ring 10 communicates with the blocking sheet 1 and is compressed into the puncture tube 2; the lower end of the puncture tube 2 is connected to the push rod 4
  • the upper end of the push rod 4 can be adjusted coaxially, the lower end of the push rod 4 is fixedly connected with the upper end of the column 6, and two through holes are opened in the axis of the push rod 4 and the column 6 parallel to each other, one through hole
  • a first pull wire 8 is set in the middle to connect with one side of the fixing ring 10
  • a second pull wire 9 is set in another through hole and connected to the other side of the fixing ring 10
  • the blocking sheet 1 and the hemostatic disc 7 are connected
  • Two perforations are opened in the hemostatic disc 7 so that the first pull wire 8 and the second pull wire 9 can pass through, so as to adjust the radial length of the hemostatic disc 7 and adjust the distance between the blocking sheet 1 and the hemostatic disc 7 through the pull wire distance, so as to play the role of ring contraction.
  • an adjustment sleeve 3 is provided on the sleeve end of the puncture tube 2 and the push rod 4, the adjustment sleeve 3 is fixedly sleeved on the outside of the puncture tube 2, and the push rod 4 is slidably sleeved on the outside of the puncture tube 2.
  • Threaded holes are arranged radially through the two pipe walls on the same side, and an adjustment handle 5 is screwed into the threaded hole, and through the adjustment handle 5.
  • the hemostatic disc 7 has a flat plate-like or sheet-like structure, and the constituent materials include pet material, medical silica gel, peek material, or a composite material of at least two or more materials.
  • one end of the puncture tube 2 is provided in a needle shape, so as to facilitate puncturing.
  • the blocking sheet 1 is a shrinkable and expandable wire braided mesh and is at least partially connected to the fixing ring 10. In the contracted state, it is stored in the puncture tube 2 in a columnar shape, and is driven by the push rod. 4. After the puncture tube 2 is pushed out, it expands into a mesh umbrella-shaped braided mesh.
  • the blocking sheet 1 is an elastic stretchable disc with openings on opposite sides and the middle bottom of the elastic stretchable disc, and the first pull wire 8 and the second pull wire 9 pass through the bottom opening. After reaching the openings on both sides, plugs are set at the openings on both sides, the diameter of the plugs is larger than the diameter of the two end openings, and the plugs are connected with the first pull wire 8 and the second pull wire 9 .
  • one side of the adjusting handle 5 is provided with knurling.
  • the blocking sheet 1 is made of an elastic nickel-titanium alloy; the fixing ring 10 is composed of a shape memory metal or a shape memory polymer material with a shape memory function.
  • An installation method of the above-mentioned ring reducer see Fig. 7 and Fig. 8, the method includes:

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Abstract

一种环缩器及其安装方法，涉及到医疗器械领域，环缩器包括封堵片（1）、止血盘（7）、穿刺管（2）、推送杆（4），推送杆（4）的一端贯穿穿刺管（2）的内腔并延伸至穿刺管（2）的内腔外。推送杆（4）用于将穿刺管（2）内的封堵片（1）推出以撑开，还在拉线处设置止血盘（7）连接封堵片（1），通过拉线可以有效调整封堵片（1）与止血盘（7）之间的距离，从而起到环缩的作用。其结构合理，通过封堵片（1）的柔性设计，从而使得手术创伤小，组织恢复较快，从而达到治疗反流的目的，拉线采用高分子材料制作而成，表面光滑可实现微创目的，器械较小，均采用光滑圆管输送，路径较简单，手术简单操作，容易实现生产研发，从而降低手术成本。

Description

一种环缩器及其安装方法 技术领域
本发明涉及医疗器械领域，具体涉及一种应用于二尖瓣手术辅助用的环缩器及其安装方法。
背景技术
二尖瓣即左房室瓣，又称“僧帽瓣”，附于左纤维房室环上，系由心内膜的皱褶形成，有两个瓣膜，位于前内侧者为前尖瓣，较大，常称大瓣，是左心室流入道与流出道的分界标志，位于后外侧者为后尖瓣，较小，常称小瓣，瓣膜呈三角形，尖朝向左室腔，两个瓣膜底部边缘常相互融合，有时在两瓣间出现小的副瓣，瓣尖、边缘及其室面有许多腱索连于乳头肌，心室收缩时，二尖瓣即严密关闭房室口，防止血液逆流入左心房，因此对于二尖瓣反流治疗需要使用到环缩器。
对于二尖瓣反流治疗需要使用到环缩器，然而，传统的环缩器结构简单，功能单一，操作复杂，且传统的环缩器多为刚性结构，增加了手术难度，延长了手术时间，从而对患者造成不必要的伤害；其次，传统的环缩器未设置穿刺针装置，使得二尖瓣反流治疗创伤性较大；因此，亟需一种结构简单、带穿刺结构的弹性或柔性环缩器。
发明内容
本发明的目的在于提供一种环缩器及其安装方法，以解决上述问题。
为实现上述目的，本发明提供如下技术方案：一种环缩器，包括封堵片、穿刺管、推送杆、立柱、止血盘、第一拉线和第二拉线；其中，所述封堵片具有形状记忆功能，可以压握进入较之更小尺寸的鞘管，封堵片由固定环固定，固定环工作时凸出于所述穿刺管的顶端，非工作状态时所述固定环连通封堵片压缩至所述穿刺管内；穿刺管的下端与所述推送杆的上端可调节的同轴套接，所述推送杆的下端与所述立柱的上端固定连接，在所述推送杆和立 柱的轴线平行的贯通开设两个通孔，一个通孔中设置第一拉线与固定环的一侧连接，另一个通孔中设置第二拉线且与固定环的另一侧连接，封堵片与止血盘通过拉线连接。
优选的，在所述止血盘开设两个穿孔以便于第一拉线和第二拉线穿过，以此通过止血盘的径向长度调整、以及通过拉线调整封堵片与止血盘之间的距离，从而起到环缩的作用。
优选的，在所述穿刺管和推送杆的套接端部设置调节套，所述调节套固定套接在所述穿刺管的外部，所述推送杆滑动的套接在所述穿刺管内；在所述调节套和穿刺管上径向贯穿同一侧的两管壁设置螺纹孔，并在所述螺纹孔内旋接一个调节手柄，通过所述调节手柄将推送杆在穿刺管定位。
优选的，所述穿刺管的一端为针状设置。
优选的，所述环缩器的封堵片为弹性镍钛合金材质；所述固定环为具有形状记忆功能的形状记忆金属或形状记忆高分子材料组成。
优选的，所述封堵片为一根可收缩扩张的丝编织网并至少部分的连接至所述固定环上，在收缩状态呈柱状收纳于所述穿刺管内，在由所述推送杆推出穿刺管后扩张呈网格伞盖状编织网。
优选的，所述封堵片为一根弹性伸缩盘，且在所述弹性伸缩盘相对的两侧及中间底部开口，所述第一拉线、第二拉线从底部开口穿过到达两侧开口，并在两侧开口处设置堵头，所述堵头的直径大于两个端部开口的直径，堵头与第一拉线和第二拉线连接。
优选的，当横管撑开时，其从中间开口相对的一侧外凹，形成弹性可调的弧状结构。
优选的，拉线采用高分子材料制作而成表面光滑。
优选的，止血盘为扁平板状或片状结构，外形可以是圆盘，或星形，或方形，或其他不规则形状结构。构成材料包括pet材料、医用硅胶、peek材 料，或是至少两种以上材料的复合材料。
操作原理：首先封堵片为压缩成直线状态收纳于在穿刺管孔里面，通过穿刺管在左心房靠近P2位置刺穿房间隔通过推送杆推送封堵片使封堵片打开成网盘装，然后穿刺管与推送杆依次撤离，撤离后第一拉线与第二拉线分别穿入止血盘孔里然后使止血盘贴合在心脏表面进行止血，通过第一拉线第二拉线进行交叉打结使心房与瓣环缩小故起到反流面积减少，缩器结构简单，功能较全，操作简单，封堵片采用柔性材料编制而成对组织伤害较小且容易使组织增长恢复，故达到微创的目的。
本发明的技术效果和优点：
1、本发明结构合理,封堵片为压缩成直线状态安装在穿刺管孔里面，通过穿刺管在左心房靠近P位置(穿刺位置)刺穿房间隔通过推送杆推送封堵片使封堵片打开成网盘装，然后穿刺管与推送杆依次撤离，撤离后第一拉线与第二拉线分别穿入止血盘孔里然后使止血盘贴合在心脏表面进行止血，通过第一拉线第二拉线进行交叉打结使心房与瓣环缩小故起到反流面积减少；
2、本发明中，通过封堵片的柔性设计，从而使得手术创伤小，组织恢复较快，从而达到治疗反流的目的，拉线采用高分子材料制作而成表面光滑可实现微创目的，器械较小，均采用光滑圆管输送，路径较简单，手术简单操作，容易实现生产研发，从而降低手术成本。
附图说明
图1为本发明立体结构示意图；
图2为本发明正视结构示意图；
图3为本发明局部放大结构示意图；
图4为本发明局部放大结构示意图；
图5为本发明图1中A处放大结构示意图；
图6为封堵片的第二实施例的示意图；
图7为本发明器械植入路径示意图；
图8为本发明器械植入后示意图。
图中：1、封堵片；2、穿刺管；3、调节套；4、推送杆；5、锁紧螺柱；6、立柱；7、止血盘；8、第一拉线；9、第二拉线；10、固定环。
具体实施方式
下面将结合本发明实施例中的附图，对本发明实施例中的技术方案进行清楚、完整地描述，显然，所描述的实施例仅仅是本发明一部分实施例，而不是全部的实施例。基于本发明中的实施例，本领域普通技术人员在没有做出创造性劳动前提下所获得的所有其他实施例，都属于本发明保护的范围。
本发明提供了如图1-6所示的应用于二尖瓣环缩器，环缩器包括封堵片1、穿刺管2、推送杆4、立柱6、止血盘7、第一拉线8、第二拉线9和固定环10。
连接关系：封堵片1具有形状记忆功能，可以压握进入较之更小尺寸的鞘管，封堵片由固定环10固定，固定环10也具有形状记忆功能。固定环10工作时凸出于所述穿刺管2的顶端，非工作状态时所述固定环10连通封堵片1压缩至所述穿刺管2内；穿刺管2的下端与所述推送杆4的上端可调节的同轴套接，所述推送杆4的下端与所述立柱6的上端固定连接，在所述推送杆4和立柱6的轴线平行的贯通开设两个通孔，一个通孔中设置第一拉线8与固定环10的一侧连接，另一个通孔中设置第二拉线9且与固定环10的另一侧连接，封堵片1与止血盘7通过拉线连接。
在所述止血盘7开设两个穿孔以便于第一拉线8和第二拉线9穿过，以此通过止血盘7的径向长度调整、以及通过拉线调整封堵片1与止血盘7之间的距离，从而起到环缩的作用。
进一步的，在所述穿刺管2和推送杆4的套接端部设置调节套3，所述调节套3固定套接在所述穿刺管2的外部，所述推送杆4滑动的套接在所述穿 刺管2内；在所述调节套3和穿刺管2上径向贯穿同一侧的两管壁设置螺纹孔，并在所述螺纹孔内旋接一个调节手柄5，通过所述调节手柄5将推送杆4在穿刺管2定位。
进一步的，在所述止血盘7开设两个穿孔以便于第一拉线8和第二拉线9穿过。所述止血盘7为扁平板状或片状结构，构成材料包括pet材料、医用硅胶、peek材料，或是至少两种以上材料的复合材料。
其中，所述穿刺管2的一端为针状设置，以便于穿刺。
进一步的，所述封堵片1为可收缩扩张的丝编织网并至少部分的连接至所述固定环10上，在收缩状态呈柱状收纳于所述穿刺管2内，在由所述推送杆4推出穿刺管2后扩张呈网格伞盖状编织网。
另一实施例中，所述封堵片1为一根弹性伸缩盘，且在所述弹性伸缩盘相对的两侧及中间底部开口，所述第一拉线8、第二拉线9从底部开口穿过到达两侧开口，并在两侧开口处设置堵头，所述堵头的直径大于两个端部开口的直径，堵头与第一拉线8和第二拉线9连接。
其中，所述调节手柄5的一侧为滚花设置。
材质：封堵片1为弹性镍钛合金材质；所述固定环10为具有形状记忆功能的形状记忆金属或形状记忆高分子材料组成。
一种上述环缩器的安装方法，参见图7和图8，方法包括：
S1穿刺，准备环缩器，将收纳收缩状态封堵片1的穿刺管2穿刺心房隔壁；
S2撑开封堵片，松开锁紧螺柱5，手推推送杆4，将封堵片1推出穿刺管2，封堵片1打开呈撑开状态；
S3退出辅件，封堵片1撑开后，依次退出推送杆4和穿刺管2；
S4安装止血盘，将第一拉线8和第二拉线9穿过止血盘7的两孔，推进靠向心脏外表，并将外部的第一拉线8和第二拉线9打结，以使心房与瓣环 缩小起到减小反流面作用，完成环缩器安装。
最后应说明的是：以上所述仅为本发明的优选实施例而已，并不用于限制本发明，尽管参照前述实施例对本发明进行了详细的说明，对于本领域的技术人员来说，其依然可以对前述各实施例所记载的技术方案进行修改，或者对其中部分技术特征进行等同替换,凡在本发明的精神和原则之内，所作的任何修改、等同替换、改进等，均应包含在本发明的保护范围之内。

Claims (10)

  1. 一种环缩器，其特征在于：包括封堵片(1)、穿刺管(2)、推送杆(4)、立柱(6)、止血盘(7)、第一拉线(8)和第二拉线(9)；其中，所述封堵片(1)具有形状记忆功能，可以压握进入较之更小尺寸的鞘管，封堵片(1)由固定环(10)固定，固定环(10)工作时凸出于所述穿刺管(2)的顶端，非工作状态时所述固定环(10)连通封堵片(1)压缩至所述穿刺管(2)内；穿刺管(2)的下端与所述推送杆(4)的上端可调节的同轴套接，所述推送杆(4)的下端与所述立柱(6)的上端固定连接，在所述推送杆(4)和立柱(6)的轴线平行的贯通开设两个通孔，一个通孔中设置第一拉线(8)与固定环(10)的一侧连接，另一个通孔中设置第二拉线(9)且与固定环(10)的另一侧连接；封堵片(1)与止血盘(7)通过拉线连接。
  2. 根据权利要求1所述的环缩器，其特征在于：在所述穿刺管(2)和推送杆(4)的套接端部设置调节套(3)，所述调节套(3)固定套接在所述穿刺管(2)的外部，所述推送杆(4)滑动的套接在所述穿刺管(2)内；在所述调节套(3)和穿刺管(2)上径向贯穿同一侧的两管壁设置螺纹孔，并在所述螺纹孔内旋接一个调节手柄(5)，通过所述调节手柄(5)将推送杆(4)在穿刺管(2)定位。
  3. 根据权利要求1或2所述的环缩器，其特征在于：在所述止血盘(7)开设两个穿孔以便于第一拉线(8)和第二拉线(9)穿过，以此通过止血盘(7)的径向长度调整、以及通过拉线调整封堵片(1)与止血盘(7)之间的距离，从而起到环缩的作用。
  4. 根据权利要求1所述的环缩器，其特征在于：所述穿刺管(2)的一端为针状设置。
  5. 根据权利要求1所述的环缩器，其特征在于：所述封堵片(1)为可收缩扩张的丝编织网并至少部分的连接至所述固定环(10)上，在收缩状态呈柱状收纳于所述穿刺管(2)内，在由所述推送杆(4)推出穿刺管(2)后扩 张呈网格伞盖状编织网。
  6. 根据权利要求1所述的环缩器，其特征在于：所述封堵片(1)为一根弹性伸缩盘，且在所述弹性伸缩盘相对的两侧及中间底部开口，所述第一拉线(8)、第二拉线(9)从底部开口穿过到达两侧开口，并在两侧开口处设置堵头，所述堵头的直径大于两个端部开口的直径，堵头与第一拉线(8)和第二拉线(9)连接。
  7. 根据权利要求5或6所述的环缩器，其特征在于：所述环缩器的封堵片(1)为弹性镍钛合金材质；所述固定环(10)为具有形状记忆功能的形状记忆金属或形状记忆高分子材料组成。
  8. 根据权利要求2所述的环缩器，其特征在于：所述调节手柄(5)的一侧为滚花设置。
  9. 根据权利要求3所述的环缩器，其特征在于：所述止血盘(7)为扁平板状或片状结构，构成材料包括pet材料、医用硅胶、peek材料，或是至少两种以上材料的复合材料。
  10. 根据权利要求1-9任一项所述的环缩器进行二尖瓣手术的环缩器安装方法，其特征在于，方法包括：
    S1穿刺，准备环缩器，将收纳收缩状态封堵片(1)的穿刺管(2)穿刺心房隔壁；
    S2撑开封堵片，松开调节手柄(5)，手推推送杆(4)，将封堵片(1)推出穿刺管(2)，封堵片(1)打开呈撑开状态；
    S3退出辅件，封堵片(1)撑开后，依次退出推送杆(4)和穿刺管(2)；
    S4安装止血盘，将第一拉线(8)和第二拉线(9)穿过止血盘(7)的两孔，推进靠向心脏外表，并将外部的第一拉线(8)和第二拉线(9)打结，以使心房与瓣环缩小起到减小反流面作用，完成环缩器安装。
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