CN106102659A - 用于微创瓣膜置换手术具有机械性或生物性心瓣膜的支架及支架施加装置 - Google Patents

用于微创瓣膜置换手术具有机械性或生物性心瓣膜的支架及支架施加装置 Download PDF

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CN106102659A
CN106102659A CN201580013457.9A CN201580013457A CN106102659A CN 106102659 A CN106102659 A CN 106102659A CN 201580013457 A CN201580013457 A CN 201580013457A CN 106102659 A CN106102659 A CN 106102659A
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support
lobe
valve
bringing device
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安东尼欧·法兰西斯寇·纳维斯·费侯
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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
    • A61F2/2412—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
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    • 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
    • A61F2/82—Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/86—Stents in a form characterised by the wire-like elements; Stents in the form characterised by a net-like or mesh-like structure
    • A61F2/90—Stents in a form characterised by the wire-like elements; Stents in the form characterised by a net-like or mesh-like structure characterised by a net-like or mesh-like structure
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    • A61F2/02—Prostheses implantable into the body
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    • 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
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    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
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    • 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
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    • A61F2/2442—Annuloplasty rings or inserts for correcting the valve shape; Implants for improving the function of a native heart valve
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    • A—HUMAN NECESSITIES
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    • 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
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Abstract

本发明揭示一种心脏支架，具有用于心瓣膜置换手术的固定瓣部，并且可以将机械性或生物性瓣膜设置在固定于支架内部的适配器中。支架是设置在由椭圆环或瓣膜成形术环维持的心瓣膜中。对于将支架于瓣膜中定位的过程，本发明提供了一种施加装置，可以在其内部组装支架并且将支架保持在可以使用的状态。

Description

用于微创瓣膜置换手术具有机械性或生物性心瓣膜的支架及 支架施加装置
本发明揭示了一种具有用于将心瓣膜置换或手术中使用的机械性或生物性瓣膜定位的机制的心脏支架，以及一种支架施加装置。本发明所提供的支架是由格栅材料所制成并且是具有两个瓣部的管状，使得心瓣膜可以固定于支架中。施加装置具有内部设置有支架的注射器，且所述的注射器包括具有螺纹的盖体，如此可以通过节省空间的解决方案存放支架。两个螺丝穿刺通过注射器的柱塞并且固定支架结构。
背景技术
现有技术中包含了各种心瓣膜置换手术中使用的装置，尤其是各种支架。这些支架中的某一些支架具有施加装置，特别是设计在定位过程中所使用的施加装置。
二尖瓣病变的手术方法需要应用瓣膜成形术环来固定基底，由于需要对固定导线进行锚固，相较之下为非常耗费时间的手术过程。
专利文件WO2009134701(A2)中揭示了一种二尖瓣膜置换手术用的定位、开启与固定系统。所述系统包括了一种格栅材料，当所述格栅材料从施加装置中释放出来时，会开启适应于二尖瓣膜形状的端部。留在心室中的端部会由锚固至心肌的张力线所固定。专利文件US2013/0172978及WO2013096541中也揭示了相似的结构。
在本发明中以及其他所提及的专利文件中，揭示了一种为此支架所开发的特定的施加装置。
不同的地方在于，本发明中包括了一种不使用张力线来进行固定的心瓣膜用的心脏支架。换句话说，这个支架是由安装在自身结构中的瓣部所固定。
现有技术中包括了治疗心瓣膜功能障碍的各种不同的解决方案。其中一种传统的方法包括了使用如斯塔尔-爱德华兹(最初由专利文件US3099016所揭示)的机械性侧流阀。这种装置是包含在设置于血流路径上并用于分流血流的封闭组件中，且这种封闭组件通常为球形。最初的设计中面对到了非常多的缺点，例如，笼干的结构脆弱性、球体的低抗性(造成隔膜损伤)以及患者对抗凝药物治疗的永久需求。瓣膜的位置同时也应被当成对患者健康有重要影响的因素。
阻塞装置的演进是在正向流动机械性瓣膜的发展过程中发生的，包括了允许单向血流的支点结构。然而，这种阻塞装置仍然具有缺点，例如，机械疲劳、抗凝药物的使用以及心瓣膜的钙化。专利文件PI9700076-0以及US6113631中提出了对上述现有技术的缺点的部分解决方案。
一种替代的方案中使用了主要由生物性组织(牛或猪的心包)所制成的生物性瓣膜，来模仿构成人体心瓣膜的叶片。专利文件PI9202905-1及US6358277中揭示了这种概念。
另一方面，专利文件PI0711664-0中揭示了一种装置，用于在二尖瓣脱垂的情况中置换受到伤害的腱索。此文件中没有提及也没有提供任何将此装置应用在心瓣膜置换手术中的信息。在此文件中，提供了一种利用线材与钩部的粗略连结。与上述文件相似，国际申请案WO2012106602中揭示了一种装置以及一种定位方法，所述装置与方法中应用了与PI0711664-0相同的某些共同组件。
US2013079873申请案中，教示了包括具有阀定位与支持的人工瓣膜的一组装置，包括了用于支持二尖瓣环的固定装置、提供能够防止炼条打滑的关闭机构，并且提及了固定装置可以为螺丝的可能性。这种装置的其中一种固有限制在于，不可能对炼条的尺寸实时进行调整。在需要调整的情况中，必需先将装置拆下来、调整后在重新定位在瓣膜上。此外，固定支持组件的曝露容易造成污染甚至使心肌受到伤害。
根据上述的现有技术，本发明旨在提供一种新的心瓣膜置换或替换手术中所使用的支架以及施加装置，以提供较高的可靠性、较少的手术时间以及较低的设备成本。
附图说明
图1为显示施加装置可以以两种方式被引入心肌中的示意图。在两种方式中，支架3是由施加装置(1或2)引入，而施加装置可以从心脏的上部、右心房、左心房设置或穿过肺动脉设置1；或者，作为替代方案，可以从心肌层的下部的切口设置2。
图2A与图2B为设置在施加装置中的支架的组件的示意图，其分别显示了根据施加装置1从心肌层的上部1的引入过程，或者施加装置2从心肌层的下部2的引入过程。对于两个组件的需求，是用于使支架3在心瓣膜中被正确的定位。
图2C为显示穿透施加装置1的柱塞5以与支架结构3链接的螺丝7的示意图，优选地，链接的位置是在支架的上瓣部8。
图3为显示内部固定有适配器12的支架3的组件的分解图，图中显示的机械性瓣膜11或生物性瓣膜10由螺丝固定。
图4A、图4B及图4C中分别显示了具有生物性瓣膜10或机械性瓣膜11的开启的支架3，图中没有显示心瓣膜。图4D显示了具有机械性瓣膜11的支架3的剖视图。
附图详细说明
图1中在上部显示了施加装置1，且施加装置1中固定有伸展型态的支架3。当在将施加装置定位并且将支架3释放进入患者的心肌阀中时，支架会展开，使得支架3的上瓣部8停留在心肌阀上方，且下瓣部9停留在心肌阀下方。
相同的图1中也显示了施加装置2从心肌层的下部进入的第二个手术选择，使得支架3可以由施加装置引入。
图2A与图2B显示了设置在施加装置1、2中的支架3的组件，使得支架3在施加装置中被拉伸并压缩。在组件2A中，支架结构3是穿过上瓣部8，且上瓣部8是由螺丝7连接至柱塞5。在此实施例中，施加装置必须从心肌层的上部引入。图2B显示了支架3以与图2A相反的方式设置在施加装置2中的配置，图2B的配置允许支架3以相同的位置设置在心肌阀中。
综上所述，支架3组装在施加装置(1或2)中的位置，是由施加装置在心肌层中的引入点来决定。
此外，施加装置(1或2)可以用作为支架3的存储设备。据此，可以选择性的提供用于密封施加装置的盖体4，以允许施加装置中可以充填保存液体。
图2C显示了支架3在施加装置(1或2)的螺丝7上的固定特征。
图3的分解图显示了在开启位置时的支架3、具有螺纹的适配器12以及机械性瓣膜11；所述机械性瓣膜11是由移动装置13固定及引导，而移动装置13是通过固定组件14连接至瓣膜11。可选的，机械性瓣膜11可以由生物性瓣膜10置换。
图4A、图4B及图4C分别显示了具有生物性瓣膜10及具有机械性瓣膜11并在开启位置的支架3，图中没有显示瓣膜。
图4D显示了装置的剖视图，图中的机械性瓣膜11安装在支架主体3中，且上瓣部8与下瓣部9是处在施加至心瓣膜的位置中。
发明说明
本发明的装置包括了用于心瓣膜的支架组件以及支架的施加装置。所述支架具有管状，且其中的一端部具有一上瓣部8以及一下瓣部9。当支架3从施加装置(1或2)中释放出来时，管状结构会伸展开来且瓣部会开启，如此一来，支架3便会被固定至心瓣膜。
由于其形状的缘故，支架需要特定的施加装置(1或2)才能使用。施加装置(1或2)包括了有两个螺丝6穿过的一柱塞5。螺丝6在其中一端部的调整位置是位于施加装置(1或2)的外部，且螺纹端7是位于施加装置的内部。如图2C所示，支架3是连结至螺纹部7并且被保持在施加装置中。优选地，施加装置必须具有解剖的形状，以方便在抵达心肌之前在动脉内移动。
可以选择将施加装置保留在组装的型态并且通过一盖体4密封，以允许支架3被保留在如甲醛的保存液体中。
不论进行哪种手术，都可以通过瓣膜成形术环或事先被插入的心瓣膜，在这些情况中对支架进行机械性支持。根据手术的进行方法，支架必须被设置在施加装置(1或2)内部。这是因为支架3的瓣部(8和9)必须被设置在心瓣膜中，而支架主体必须被保持在瓣膜的心室部分中。
在通过心肌层的上部进行的施加手术中，支架3必须与靠近柱塞5的瓣部组装。在通过心肌层的下部进行的手术中，支架3必须与靠近施加装置2的出口处的瓣部(8和9)组装。通过上述两种组件，可以确保支架3在心瓣膜中位于正确的位置。此外，支架3在管状结构的内部必须具有一瓣膜。所述的瓣膜必须允许血流只能往一个方向流动：永远只能从心房往心室流动，以避免在此区域中的倒流。
上述的瓣膜是被组装在适配器12中，而适配器12是被固定至支架主体3。优选地，适配器12是被固定在两个瓣部(8和9)之间。
所述的瓣膜可以由生物性材料10或机械性材料11制成。在生物性瓣膜的案例中，支架3会在施加装置(1或2)中被压缩，并且被存放在保存液体中。然而，当使用机械性瓣膜11时，支架3必须不与机械性瓣膜11一起存放，且必须以仅有上瓣膜8及下瓣膜9在施加装置(1或2)中被压缩的方式存放。
作为替代的方案，支架可以不与机械性瓣膜11一起存放，而机械性瓣膜适配器9组件在手术过程中是被固定在支架3内部。

Claims (14)

1.一种用于微创瓣膜置换手术具有机械性或生物性心瓣膜的支架，包括具有管状以及格栅结构的一支架主体(3)，其特征在于，
所述支架主体(3)的一端部具有一上瓣部(8)以及一第二下瓣部(9)，所述第二下瓣部(9)是靠近并平行于所述上瓣部(8)，并且位于上瓣部(8)与所述支架主体(3)的中间部分之间，所述上瓣部(8)、所述第二下瓣部(9)与所述支架主体(3)是由线材制成并且涂覆有惰性材料，所述惰性材料允许二尖瓣环的生理运动以及一适配器(12)的设置，所述适配器(12)是用于将一心瓣膜支持在所述支架(3)的所述上瓣部(8)与所述第二下瓣部(9)之间。
2.如权利要求1所述的支架，其特征在于，所述心瓣膜是具有允许单向流动的两个闸门的一机械性瓣膜(11)。
3.如权利要求1所述的支架，其特征在于，所述心瓣膜是由牛或猪的心包膜所制成的生物性瓣膜。
4.如权利要求1-3中任一项所述的支架，其特征在于，所述支架(3)的材料具有放射线不透明的性质，以允许放射线摄影可以看见所述支架(3)。
5.如权利要求1-4中任一项所述的支架，其特征在于，所述支架先前是设置在所述心瓣膜中设置支架(3)的位置，而现今是设置在椭圆环或瓣膜成形术环(20)中，所述椭圆环或瓣膜成形术环(20)是位于所述支架(3)的外部上所述上瓣部(8)与所述下瓣部(9)之间。
6.如权利要求1-5中任一项所述的支架，其特征在于，所述支架具有透过所述上瓣部(9)、所述下瓣部(9)以及位于下部分的爪部启动的一固定系统，所述爪部在瓣膜位置穿刺心脏组织。
7.如权利要求2-6中任一项所述的支架，其特征在于，所述支架仅具有所述上瓣部(8)以及所述下瓣部(9)，并且不具有支架主体(3)。
8.如权利要求1-7中任一项所述的支架，其特征在于，所述上瓣部(8)、所述下瓣部(9)以及所述支架主体(3)上设置有多个小型钩部(20)，用于抓住患者的肌肉并将所述支架(3)定位并固定至所述瓣膜成形术环。
9.如权利要求1-8中任一项所述的支架，其特征在于，所述上瓣部(8)与所述下瓣部(9)是由金属断片制成，且金属断片的结构可以协助增进所述上瓣部(8)与所述下瓣部(9)的机械阻力。
10.一种支架施加装置，其特征在于，包括一圆柱体(15)，所述圆柱体(15)中设置有由两个螺丝(6)穿过的一柱塞(5)，所述两个螺丝(6)固定并连接支架结构(3)，所述支架在所述圆柱体(15)中被伸展并拉长，设置在所述支架的端部的上瓣部(8)与下瓣部(9)面对所述柱塞(5)的侧边，使得所述支架主体(3)成为首先离开所述支架施加装置的部件。
11.如权利要求10所述的施加装置，其特征在于，与权利要求6中的叙述相反，所述支架(3)是设置在所述圆柱体(15)中，且所述支架(3)设置有所述上瓣部(8)与所述下瓣部(9)的端部会被首先释放。
12.如权利要求10或11所述的施加装置，其特征在于，所述支架施加装置在所述支架离开的端部具有一螺纹，以允许设置用于密封所述圆柱体(15)的内部的一盖体(4)。
13.如权利要求10-12中任一项所述的施加装置，其特征在于，所述支架施加装置的直径大小足以以只有瓣膜(11)在所述支架施加装置中被压缩的方式将具有机械性瓣膜(11)的支架保留在所述支架施加装置中。
14.如权利要求10-13中任一项所述的施加装置，其特征在于，所述支架施加装置具有解剖形状，较佳具有卵形，使得所述支架施加装置方便或甚至可以在血管及动脉中移动。
CN201580013457.9A 2014-03-14 2015-02-27 用于微创瓣膜置换手术具有机械性或生物性心瓣膜的支架及支架施加装置 Pending CN106102659A (zh)

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