CN106102657A - 心脏支架瓣膜和用于该瓣膜的输送装置 - Google Patents
心脏支架瓣膜和用于该瓣膜的输送装置 Download PDFInfo
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- 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
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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
- A61F2/02—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
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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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Abstract
一种心脏支架瓣膜(1),优选地为二尖瓣支架瓣膜,包括支架部件(2)和瓣膜部件(3),其中支架部件(2)包括流入端(4)和流出端(5),以及位于流入端(4)和流出端(5)之间的壁,其中瓣膜部件(3)用单个叶片(6)制成;所述单个叶片(6)的周缘沿着至少三条固定线(7',7”)被部分附接到或者可附接到支架部件(2)上,其特征在于两条固定线(7’)相对于所述瓣膜的垂直于穿过支架瓣膜(1)的流向(A)的环形平面至少部分地倾斜,其中第三条固定线(7”)平行于所述平面延伸。
Description
技术领域
本发明涉及可膨胀的支架瓣膜和用于可膨胀的支架瓣膜的输送装置。更确切地说,本发明涉及包括单个叶片的心脏支架瓣膜。
背景技术
用假体置换心脏瓣膜是复杂的手术。置换常常通过心脏直视手术进行。这种手术需要打开胸腔并使病人的心脏停跳。
US4,759,758提出了一种二尖瓣支架瓣膜,包括支架和单个瓣。通过将瓣的下边缘缝合到沿着支架的向下弯曲的边缘延伸的缝合孔上,瓣被缝合到支架的剖面上。
US4,759,758中公开的支架瓣膜是外科手术支架瓣膜,其在心脏直视手术中被缝合到心脏瓣环上。心脏直视手术是承受外科手术依从性风险(例如感染)的主要手术。
在过去几年中,已经确立了侵入最小的系统,以通过导管经皮输送支架假体。
有待通过导管输送的支架必须卷曲,以便安装在导管上或者导管内。在到达植入位置后,支架被释放,并通过自动膨胀或者借助于诸如气球或者金属丝之类的辅助工具膨胀。
WO2009/106545建议使用具有指状元件的支架,指状元件在血管壁上提供径向作用的张力。指状元件的张力锚固支架。
另一种锚固支架的可能方式依赖于允许形状配合锚固在天然组织上的支架外形。EP1893132提出了一种具有不对称的沙漏形状的支架,其中直径较大的部分通过形状配合提供支架的锚固。WO2008/028569建议提供一个用于通过形状配合来紧固支架瓣膜的圆孔。
WO2012/063228提出了一个具有支撑结构和锚固元件的方案。锚固元件与支撑结构分离,并且例如包括环。锚固元件与支撑结构的外壁配合,环绕它延伸,以便将心血管瓣膜的瓣膜叶片锁定在锚固元件和支撑结构的外壁之间。
但是,如在WO2012/063228中所述的结构有点复杂,因为它有两个单独的元件,两者必须在身体内连接。该组合必须非常精确,以提供可靠的锚固。
因此,需要能够避免现有技术缺点的支架。特别是,需要能提供具有简单有效的结构的可靠的锚固系统并且易于使用且不损伤周围组织的支架。
发明内容
此处,本发明主要描述了只有一个叶片的二尖瓣支架瓣膜。不难理解本发明还可用作其他心脏支架瓣膜。
采用根据本发明的独立权利要求的支架瓣膜,特别是可膨胀的、优选地可自动膨胀的支架瓣膜,解决了问题。该支架瓣膜包括支架部件和瓣膜部件。支架部件包括流入端和流出端以及位于流入端和流出端之间的壁。瓣膜部件包括单个叶片。叶片沿着其周缘被部分附接到或者可附接到支架部件上。这种部分附接沿着至少三条固定线被限定,或者换句话说,沿着由至少三段限定的线被限定。根据本发明,两条固定线相对于瓣膜的垂直于穿过支架瓣膜的流向的环形平面至少部分倾斜。第三条固定线平行于所述平面延伸。倾斜优选地使得叶片的自由边比叶片的被固定到支架部件上环形平面高度处的边缘更接近流出端。
两条倾斜的固定线优选地相对于环形平面以大约5°到50°之间,更优选地约25°和40°之间,优选地约35°的角度倾斜。
可膨胀的支架瓣膜要么是可自动膨胀的支架瓣膜,要么是借助于膨胀装置可膨胀的支架瓣膜。该膨胀装置可以例如是球囊。
穿过支架瓣膜的流向是流动穿过支架瓣膜的流体(即血液)的大致方向。该流向基本上平行于支架瓣膜的纵轴。
叶片可以直接或者间接地附接到支架部件。间接附接意味着叶片被附接到例如裙部之类的装置,该装置本身被附接到支架部件。叶片优选地用缝合线附接。可选地,叶片也可以用夹子、卡钉或者胶水固定。
沿着固定线附接到支架优选地是沿着线的连续附接,例如连续缝合。与采用固定的和非固定的附接区域的附接相比,采用沿着线的连续附接的瓣周漏的风险被降到最小。
叶片优选地包括心包并且优选地用心包制成。可选地,叶片可以包括其他生物材料或者生物相容的合成材料,或者用这些材料制成。
如上所述,叶片被布置成使得两条固定线相对于垂直于穿过支架瓣膜的流向的平面倾斜。第三条线优选地被布置在所述两条线之间,并且被固定成平行于或基本上平行于该垂直面。
可选地,倾斜部分差不多彼此相交于一点,即所谓的鞍头。因此,第三固定线被缩减到非常小的长度。
两条倾斜的固定线之间的一个外围部段没有形成固定线的一部分,因此就没有被固定到支架部件上。该部段也被称为叶片的自由边。
叶片可以在打开位置和闭合位置之间活动,在打开位置,自由边离开壁,允许血液流过支架瓣膜,而在闭合位置,则防止血液倒流。
二尖瓣有约70-80%的时间是打开的。本发明的支架瓣膜装置在植入二尖瓣环时保持打开不动。在心缩期叶片由于收缩压而关闭。当叶片被布置在垂直于流向的平面中时,例如在三叶型生物瓣膜中,支架瓣膜被垂直于环形平面的合力矢量推向左心房。但是,利用根据本发明的附接的叶片,即相对于流向倾斜的叶片,收缩压的合矢量将叶片沿径向推向支架部件的壁。于是,当叶片关闭时,它自动防止瓣周漏。此外,通过叶片的朝向支架部件的壁的径向压力,支架部件被压在环形组织上,从而有助于锚固支架瓣膜。叶片优选以这样的方式倾斜:支架部件主要被压在心室后壁上。
根据本发明的瓣膜还有许多优点。当瓣膜打开时,主流相对于瓣膜平面朝向倾斜的方向。主流向更优选地朝向左心室的后壁。这一流动模式已经被几位意见指导者描述为最符合生理学并且最适合于二尖瓣假体。事实上这一斜流方向允许更好地填充左心室,并且允许血液有较少的朝向主动脉的湍流喷射。
支架瓣膜优选包括至少部分覆盖支架内表面的组织支撑。组织支撑有助于避免瓣周漏。其他已知的用于减少瓣周漏的方式例如密封衬片也是可以的。使用组织支撑,血液在支架瓣膜外面的叶片周围可以不流动,至少更少流动。
支架部件的壁优选地包括支柱,支柱优选地被布置成基本呈锯齿形结构。支柱的锯齿形结构形成隔室,优选,菱形隔室。
支柱优选地具有约几毫米的直径。它们由生物相容的材料形成,例如生物相容的金属或者金属合金,例如镍钛合金。
带有基本上呈锯齿形结构的支柱的壁的布置方案提供了需要较少材料的稳定支架。此外,由于支柱之间的自由空间,这一布置可以更好地卷曲以便输送。
在心缩期,由支柱制成的壁通过作用于倾斜叶片上的收缩压会沿径向向外地被推向环形壁和心室壁,优选地心室后壁。带有支柱的布置方案有助于锚固,因为在粗糙、不平滑的表面上摩擦力更大。带有支柱和介于它们之间的自由空间的壁提供了这样的粗糙表面。
支架部件优选大体上呈D形。在此,D形意指穹隆形,它包括两部段,其中一个部段以近似圆形的方式弯曲,而另一部段基本是直的,或者在任一侧上弯成较小的度数。因此,例如,卵形意味着被术语D形涵盖。
二尖瓣环通常呈D形。因此,大体呈D形的支架部件比例如圆形更适合二尖瓣环。采用D形,支架瓣膜在植入时基本上不会变形。由于变形可能会因为例如叶片的不精确闭合而导致支架瓣膜故障,因此D形是优选的结构。
此外,也可以提供大体上为圆形的支架部件。如果支架瓣膜被用在其他瓣膜中,例如用在主动脉环中,大体上为圆形可能更好。
在二尖瓣支架瓣膜的优选实施方式中,流入端和流出端之间的距离在支架部件的前侧比在后侧短。
术语支架部件的前侧和后侧指的是植入时各部分的位置。因此,前侧处于植入时环的前部附近的区域,而后侧处于环的后部附近的区域。
二尖瓣环的前部位于主动脉环附近。通过提供具有较短的前侧的支架部件,前侧仅会延伸到前侧上的心室内一点。于是,与延伸到心室内较多的支架部件相比,该支架瓣膜不会过多妨碍血液流过主动脉环。较长的侧可以例如用较长的侧上的较大的隔室和/或另一排隔室实现。
优选地,叶片被固定在支架部件的前侧和横侧,以便倾斜的固定线位于横侧。因此自由边优选地被布置在后侧。
类似于前部和后部,横侧指的是植入时各侧的位置。前侧的固定线优选大致平行于与通过支架的流向垂直的平面。
可选地,倾斜的固定线被布置在横侧和前侧。倾斜的固定线在前侧上的接触点处相交。因此自由边也优选地被布置在后侧。
在这类布置方案中,支架在心缩期沿径向被压到心室壁和二尖瓣环的后部。如上所述,前部位于主动脉环附近。由于较少妨碍血液流过主动脉环,因此支架压在后部上是有利的。当支架被压在环的后部上时,主动脉环不变形。
此外,在后壁长于前壁的情况下,有待压在环上的表面被用上述布置放大。这进一步增加了支架瓣膜的锚固。
前壁优选地仅仅被锚固到二尖瓣环。前部的二尖瓣环靠近主动脉的瓣膜口。在前部的二尖瓣环的高度处没有心室壁。使用将支架压到心室后壁上的布置方案,前侧没有必要锚固定得和后侧一样牢。通过将支架压靠在心室后壁上,主动脉瓣优选地不受干扰,因此心室流动也不受干扰。
优选地,叶片被布置成例如至少一个叶片被布置成例如瓣膜叶片的前侧,并且自由边具有支架瓣膜的环形周缘的约30到40%的长度,而横侧的倾斜部分具有环形周缘的10%和20%之间的,优选15%的长度。
在一个优选实施方式中,支架瓣膜还包括至少两个组织支撑。该至少两个组织支撑被附接到支架部件,优选地附接到支架部件的内表面。该至少两个组织支撑优选地覆盖支架部件的一部分内表面。
在本申请的范围内,至少两个组织支撑意指有至少两个部段。至少两个组织支撑还包括两个整体成形的部段(例如一个部段覆盖支架的流入端的内表面,并且附接到覆盖支架的流出端的内表面的第二部段上,即相连的部段),以及分开的不相连的部段。
组织支撑优选地包括与叶片相同的材料,即优选地心包,并且优选地用这种材料制成。由于血液不与粗糙表面(例如支柱)直接接触,因此固定到支架部件的内表面上的组织支撑允许血液较少受干扰地流过支架。粗糙表面可能导致湍流。
可选地,组织支撑用其他材料制成,例如生物相容的合成材料。
至少一个组织支撑优选地包括附接区域。附接区域的至少一个部段优选地从内表面基本上向内延伸。至少一个叶片被附接到组织支撑上的附接区域的部段,以便叶片被布置在至少两个组织支撑的附接区域之间,或者与一个组织支撑整体成形,并且被附接到第二组织支撑的附接区域的部段。
组织支撑可以沿着支架或者环的整个周缘或者仅沿着部分周缘延伸。附接区域可以沿着整个组织支撑或者仅沿着部分组织支撑沿周向延伸。
优选地,人工瓣膜还包括支架部件。至少两个组织支撑被附接到支架部件的内表面,并且至少部分覆盖支架部件的内表面。
组织支撑可以布置成使得支架的整个长度被组织支撑覆盖,或者仅支架的部分长度被组织支撑覆盖。
叶片优选地不是直接和固定地附接到瓣膜状支架,而是通过一个或多个组织支撑间接地附接到瓣膜状支架。功能叶片的附接以及整个功能叶片本身完全处于支架内。因此,例如在心缩-心舒的打开过程中,叶片不在任何支柱或类似物上弯曲。于是,沿着这类弯曲线产生的应力得以避免。
倾斜的固定线优选地独立于支架部件的支柱的布置被附接到组织支撑上。
通过将叶片附接到组织支撑上,而不是直接附接到支架部件上,固定线的朝向不再取决于支架部件的形状,即提供附接位置的支柱的朝向。因此固定线可以独立于支柱的几何结构定向。
支架部件优选包括至少一个,优选地三个心房延长部分。
此处所述的心房延长部分是指支架的被布置成大致垂直于血液通过支架的流向的并且基本上比壁的剩余部分具有更大的隔室尺寸的部分。心房延长部分被布置在支架瓣膜的流入端。因此心房延长部分从支架瓣膜向外伸出,并且由于它们在植入时与心壁接触,因此有助于将支架瓣膜锚固和稳定在环中。
心房延长部分优选地被布置成完全环绕支架瓣膜的流入端的周缘。心房延长部分被布置成类似于花瓣在花中。于是,主动脉环基本上不变形,并且一般不会妨碍流过主动脉环的血流。
流入端上最外面的锯齿形的支柱也可以沿着支架部件的圆周沿径向向外垂直弯曲。于是,心房侧上的锚固也被加强。由于流入端上的隔室尺寸优选地相对较小,因此基本上不会妨碍主动脉的血流。
在壁由支柱形成的情况下,由支柱形成的隔室优选地至少在流出区域和流入区域具有不同的尺寸。
流出端优选地包括比流入端更大的隔室。具有较大隔室的部分一般比具有较小隔室的部分更柔韧。锯齿形的线在尺寸上也可以变化,以致在一排中产生不同尺寸的隔室,例如在一排中在后侧上的隔室比在前侧上的大。于是,支架部件的各侧可以实现不同的长度。心房瓣也优选地由流入区域中的最外面的锯齿形中的较大的锯齿线构成。
支架部件的壁优选地包括去耦元件,以减小心脏收缩-舒张支架张开过程中的应力。去耦元件优选地呈S形。
此处所述的S形是指包括利用与其他弯曲相连的条实现的各种形状,例如Z形或蛇形,即多重S形或者Z形。
去耦元件优选地被布置在具有不同尺寸的锯齿形结构之间。去耦元件连接由支柱形成的隔室中的至少一些隔室。去耦元件优选连接流入区域的最外排隔室中的一些隔室与流入方向上邻排中的隔室。
已经表明,去耦元件可以帮着抓住前部的天然叶片,以便将该叶片拉向二尖瓣环。于是,天然叶片不干扰左心室流出道。天然叶片可以完全被去耦元件夹住。
后侧上的去耦元件具有相同的效果,但后侧的天然叶片保持被夹紧在心脏后壁和支架瓣膜之间。
与支柱的宽度相比,去耦元件的宽度优选地被减小。
除了应力减小之外,去耦元件为支架瓣膜提供了更大的柔韧性。
此外更进一步,去耦元件有助于在心室收缩期将支架瓣膜保持在适当位置。
优选地,流入端和流出端中的至少一个,优选地两个,相对于与流向平行的中心轴线向外张开。
流入端优选地相对于流向张开约20°到50,更优选地约30°,而流出端相对于流向优选地张开约7.5°到17.5°,更优选地约10°。
后侧优选地以比前侧更大的角度张开。
前侧在流出端相对于轴线优选地张开约7.5°到20°,更优选地约10°,在流入端相对于轴线优选地张开约15°到30°,更优选地约20°,而后侧在流出端相对于轴线优选地张开约7.5°到17.5°,更优选地约10°,在流入端相对于轴线张开约20°到50°,更优选地约30°。不对称的张开可以与此处描述的本发明的各种假体一起存在。
在另一个备选实施方式中,张开可以作为曲线张开而提供。曲线张开意味着张开相对于轴线以圆形、凸形方式弯曲,以致张开相对于轴线分别在中间区域向外弯曲,而在靠近流入端或者流出端的区域至少稍微向内弯曲。曲线张开可以与此处描述的本发明的各种假体一起存在。
张开在心房-心室接合处和心室后壁的周围组织上提供支撑结构的力,该力保持将支撑结构固定在环中。在前部的流出端处的张开比在后部的小,这有助于将干扰主动脉流出道的风险降到最小。
支架瓣膜优选包括标记物,例如不透明的射电标记,它形成定位装置。该装置有助于在用导管植入时沿轴向和/或可旋转地定位支架。该定位装置可以包括在手术的超声影像上可见的材料。标记还可以设置在其内安装有支架瓣膜的输送装置上。
本发明还涉及包括输送装置和根据上述实施方式之一的支架瓣膜的输送系统。
附图说明
本发明的其他方面参照以下示意图描述。附图中:
图1示意性地示出了根据本发明的支架瓣膜从流出端看到的透视图。
图2a、b示意性地示出了根据图1的支架瓣膜在打开和闭合位置的侧视图。
图3示意性地示出了根据本发明的备选支架瓣膜从前侧看到的透视图。
图4示意性地示出了心脏收缩力作用于根据本发明的支架瓣膜中的叶片上的原理。
图5示意性地示出了支架瓣膜在顶视图中周向尺寸。
具体实施方式
图1表示从流出端5看到的支架瓣膜1的视图。该支架瓣膜包括支架部件2和瓣膜部件3。支架部件2包括流入端4和流出端5。在两端4,5之间,支架部件2包括壁,该壁由用镍钛合金制成的支柱8形成。支柱8被构造成锯齿形,形成不同尺寸的隔室。S形去耦元件11沿流向A连接一些隔室。去耦元件11与支柱8相比直径较小。去耦元件11的小直径和S形状在支架瓣膜1的张开过程中提供了减小的应力。同时实现了支架瓣膜1的更好的适应性。
支架部件2在流入端4上还包括三个心房延长部分9(在图1中只显示了2个,第三个被隐藏)。心房延长部分9被设置成基本上垂直于穿过支架瓣膜1的流向A。由于心房延长部分9从支架瓣膜1向外伸出,因此当植入时,心房延长部分9接触心房心壁,并且有助于固定和稳定支架瓣膜1。
瓣膜部件3包括一个叶片6,其通过沿着固定线7’、7”的缝合线而附接到组织支撑10上。叶片和组织支撑用心包制成。在将叶片6附接到组织支撑10上并由此附接到支架部件2上的同时,前侧12上的缝合线将组织支撑10附接到支架部件2上,。在横侧15’、15”上,固定线7’相对于与贯穿支架瓣膜1的流动轴线A垂直的平面倾斜。横侧15’、15”上的固定线7’从平行于所述平面延伸的固定线7”开始倾斜。前侧12上的固定线7”位于支架瓣膜1的流入端4附近。固定线7’从固定线7’以一定的角度向支架瓣膜1的流出端5延伸。叶片6的自由边14在所示的闭合位置(同时参见图2b)与支架部件2的后侧13上的壁接触。
叶片6在心舒期处于打开位置并且处于静止状态。在心缩期,血液被从左心室泵入主动脉内。受压的血液还作用在叶片6上,并随即关闭叶片6。由于叶片6的倾斜位置,因此力还将叶片6沿径向推向后壁(见图3)。通过压力,支架瓣膜1本身被推到后面的环形壁上,并随即有助于将支架瓣膜1锚固在二尖瓣环和周围的心室壁上。
图2a、2b显示了支架瓣膜1的侧视图。图2a显示处于打开位置的支架瓣膜1,图2b显示处于闭合位置。
固定线7’以相对于与流向A垂直的平面成20°和50°之间、优选约35°的角度δ延伸。角度δ在固定线7’的长度上可以变化,从固定线7”处20°的小角度δ开始,向着流出端5变到50°的大角度δ,反之亦然。
支架部件2的流出端5上的壁相对于流向A张开。后侧13的壁以约20度的角度ε’张开,而前侧12的壁以约18°的角度ε”张开。
前侧12具有约15到17毫米的长度l1,而后侧13具有约32毫米的较长的长度l2。瓣膜的长度为大约30到45毫米,优选约34毫米。
在图2a所示的打开位置,叶片的自由边14未与支架部件2的后壁接触。在应力消除的状态下,叶片6的自由边14从倾斜的固定线7’伸入左心房。在打开位置,血液可以沿着流向A从左心室通过支架瓣膜1流入心脏的左心房。
在图2b所示的闭合位置,收缩压已将叶片的自由边14推到后壁上。叶片6的闭合位置防止血液从左心房回流到左心室。通过将叶片6推到后壁上,朝向后方的力B(见图3)作用于支架瓣膜1上。支架瓣膜1随即被向后方推,帮助在心缩期间锚固支架瓣膜1。左心室的动力有助于将支架瓣膜锚固在二尖瓣位置。
图3显示了从前侧12看到的根据本发明的备选支架瓣膜1。该支架瓣膜包括支架部件2和瓣膜部件3。瓣膜部件3被用缝线沿着倾斜的固定线7’固定到支架部件2上。倾斜的固定线位于横侧15’、15”处和前侧2处。倾斜的固定线7’在前侧12上相交于接触点16,即所谓的鞍头(saddle-horn)。两条固定线7’从鞍头16都以约5到10度的角度ζ倾斜。该角度朝向流出端增加,在横侧15’,15”上增加到约35°的角度。
图4显示了力B在心缩期作用于叶片6上并随即作用于支架瓣膜1上的原理。该动力在心缩期将叶片6推到后侧13上。叶片6在如图3所示的整个长度上可以不改变位置,因为倾斜部分至少部分被固定到支撑组织10上。
使用倾斜叶片6实现了较大的接合。该接合在长度上最小有10毫米。在二尖瓣(压力比在例如三叶假体中小)中,较大的接合表面对瓣周漏的最小化很重要。
图5用顶视图显示支架瓣膜1的周向尺寸。固定线7”在前侧12上具有约30%到40%的周向尺寸γ。每个横侧15’、15”的固定线7’具有约10%到20%的周向尺寸β。后侧13上的自由边14具有约30%到40%的周向尺寸α。固定线7’的长度为大约25毫米。
Claims (17)
1.一种心脏支架瓣膜(1),优选地为二尖瓣支架瓣膜,包括支架部件(2)和瓣膜部件(3),其中支架部件(2)包括流入端(4)和流出端(5)以及位于流入端(4)和流出端(5)之间的壁,并且其中瓣膜部件(3)由单个叶片(6)构成;所述单个叶片(6)的周缘沿着至少三条固定线(7’,7”)被部分附接到或者可附接到支架部件(2)上,其特征在于,两条固定线(7’)相对于所述瓣膜的垂直于穿过支架瓣膜(1)的流向(A)的环形平面至少部分倾斜,并且其中第三条固定线(7”)基本上平行于所述平面延伸。
2.根据权利要求1所述的支架瓣膜(1),其中所述两条固定线(7’)相对于环形平面以大约5°到50°之间,优选地大约25°和40°之间,更优选地大约35°的角度倾斜。
3.根据权利要求1或者2所述的支架瓣膜(1),其中壁包括支柱(8),所述支柱优选地基本上布置成锯齿形结构。
4.根据权利要求1至3中一项所述的支架瓣膜(1),其中支架部件(2)大体上是D形。
5.根据权利要求1至4中一项所述的支架瓣膜(1),其中流入端(4)和流出端(5)之间的距离在支架部件(2)的前侧(12)比在后侧(13)短。
6.根据前述权利要求中一项所述的支架瓣膜(1),其中所述单个叶片(6)被附接在支架部件(2)的前侧(12)和横侧(15’,15”),以便所述两条固定线(7’)被布置在横侧(15’,15”)。
7.根据权利要求1至5中一项所述的支架瓣膜(1),其中所述单个叶片(6)被附接在支架部件(2)的前侧(12)和横侧(15’,15”),以便所述两条固定线(7’)被布置在横侧(15’,15”)和前侧(12),在前侧(12)处具有接触点。
8.根据前述权利要求中一项所述的支架瓣膜(1),其中所述单个叶片(6)被布置成使得前侧和瓣膜叶片(6)的自由边(14)均具有支架瓣膜(1)的环形周缘的大约30%到40%的长度,并且横侧处的倾斜部分优选地具有环形周缘的10%到20%之间,优选15%的长度。
9.根据前述权利要求中一项所述的支架瓣膜(1),还包括至少两个组织支撑(10),所述组织支撑附接到支架部件(2)上,优选地附接到支架部件(2)的内表面上,并且覆盖支架部件(2)的至少一部分内表面。
10.根据权利要求9所述的支架瓣膜,其中所述单个叶片(6)被附接到组织支撑(10)。
11.根据前述权利要求中一项所述的支架瓣膜(1),其中支架部件(2)还包括至少一个,优选地三个心房延长部分(9)。
12.根据权利要求3至11中一项所述的支架瓣膜(1),其中由支柱(8)形成的隔室至少在流出区域和流入区域具有不同的尺寸。
13.根据前述权利要求中一项所述的支架瓣膜(1),其中壁包括在支架张开的过程中减小应力的去耦元件(11),其优选地为S形。
14.根据权利要求13所述的支架瓣膜(1),其中去耦元件(11)适合抓住天然叶片,优选地前部的天然叶片,以将天然叶片拉向二尖瓣环。
15.根据前述权利要求中一项所述的支架瓣膜(1),其中流入端(4)和流出端(5)中的至少一个,优选地两个,相对于平行于流向(A)的中心轴线向外张开。
16.根据权利要求15所述的支架瓣膜(1),其中后侧(13)以比前侧(12)大的角度张开。
17.一种输送系统,包括输送装置和根据权利要求1至16中一项所述的支架瓣膜。
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US11511103B2 (en) | 2017-11-13 | 2022-11-29 | Shifamed Holdings, Llc | Intravascular fluid movement devices, systems, and methods of use |
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US11229784B2 (en) | 2018-02-01 | 2022-01-25 | Shifamed Holdings, Llc | Intravascular blood pumps and methods of use and manufacture |
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CN111671551B (zh) * | 2020-06-17 | 2022-04-15 | 金仕生物科技(常熟)有限公司 | 一种经导管二尖瓣支架 |
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EP3116445B1 (en) | 2019-04-03 |
US20170065409A1 (en) | 2017-03-09 |
CN113133854A (zh) | 2021-07-20 |
CA2941121A1 (en) | 2015-09-17 |
BR112016020740A2 (zh) | 2017-08-15 |
JP2017506988A (ja) | 2017-03-16 |
US10779935B2 (en) | 2020-09-22 |
CA2941121C (en) | 2022-02-01 |
WO2015135763A1 (en) | 2015-09-17 |
EP2918248A1 (en) | 2015-09-16 |
BR112016020740B1 (pt) | 2021-09-21 |
EP3116445A1 (en) | 2017-01-18 |
JP6534395B2 (ja) | 2019-06-26 |
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