CN111885982A - 柔性顶盖瓣膜修复系统和使用方法 - Google Patents
柔性顶盖瓣膜修复系统和使用方法 Download PDFInfo
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Abstract
一种用于治疗心脏瓣膜中的瓣膜反流的系统,该系统包括柔性顶盖以及包括弹性部分和非弹性部分的细长系绳。当系统处于部署构造时,柔性顶盖的近端联接于心脏瓣膜的瓣环,并且细长系绳的远端联接于心室。柔性顶盖构造成覆盖心脏瓣膜的第一天然瓣叶,并且施加和/或调节在细长系绳上的张力以防止第一瓣叶脱垂,以使柔性顶盖与第二冠状动脉的第二天然瓣叶的合紧最大化,并使心脏瓣膜反流最小化。
Description
相关申请的交叉引用
本申请要求2018年3月20日提交的美国临时专利申请序列第62/645,306号的权益,其全部公开内容为所有目的而以参见的方式纳入本文。本申请要求还要求2019年3月14日提交的美国专利申请序列第16/352,963号的权益,其全部公开内容为所有目的而以参见的方式纳入本文。
技术领域
本技术总体上涉及用于修复经受反流的瓣膜的系统以及相关联的系统和方法。
背景技术
人类心脏是四腔肌肉器官,其在心动周期期间提供通过身体的血液循环。这四个主要腔室包括供应肺循环的右心房和右心室,以及将接收自肺的含氧血供应至其余身体的左心房和左心室。为了确保血液沿一个方向流过心脏,在心房与心室之间存在房室瓣膜(三尖瓣和二尖瓣),且半月瓣(肺动脉瓣和主动脉瓣)控制心室通向肺和身体其余部分的出口。这些瓣膜包含瓣叶或瓣尖,这些瓣叶或瓣尖响应于由心腔的收缩和舒张所引起的血压变化而打开或关闭。各瓣叶远离彼此地运动,以打开而允许血液向瓣膜的下游流动,以及合紧而关闭并阻止以朝上游的方式的逆流或回流。
还已知为双尖瓣(bicuspid)或左房室瓣的二尖瓣是位于左心房与左心室之间的双片瓣。二尖瓣用于引导含氧血液从肺部穿过心脏的左侧进入主动脉,以分配给身体。就像心脏中的其它瓣膜,二尖瓣是被动结构,这是因为其自身不消耗任何能量并且不执行任何主动的收缩功能的缘故。二尖瓣包括两个可动瓣叶、即前瓣叶和后瓣叶,这两个瓣叶各自响应于在瓣膜的两侧上不同的压力而打开和关闭。理想地,瓣叶在瓣膜处于打开构造中时彼此远离地运动,且在瓣膜处于关闭构造中时相接触或“合紧”。
比如由损害或缺陷所引起的那些与心脏瓣膜相关的疾病可包括狭窄和瓣膜功能不全或回流。这些疾病可在同一瓣膜中单独或同时发生。当瓣膜不完全关闭时,发生瓣膜功能不全或回流,从而允许血液回流,由此引起心脏效率较低。病变或受损的瓣膜可以是先天性的、与年龄相关的、药源性的、或在一些情形中由感染所引起,该患病或受损的瓣膜可导致扩大且增厚的心脏,这样的心脏损失了弹性和效率。心脏瓣膜疾病的一些症状可包括虚弱、呼吸短促、眩晕、晕厥、心悸、贫血和水肿以及血块,其可增加中风或肺栓塞的可能性。这些症状通常可能严重到足以使人衰弱和/或威胁生命。
具体地,二尖瓣退行性反流的很大一部分或百分比是由二尖瓣后瓣叶脱垂引起的。这可能是由于附连于后瓣叶上的腱索变弱或分离所致。在这种情况下,当二尖瓣处于关闭构造时,二尖瓣后瓣叶会像风帆或降落伞一样向左心房鼓起或隆起,导致后瓣叶无法与二尖瓣前瓣叶完全合紧。
当前,用于修复脱垂的瓣叶的治疗选择包括切除脱垂组织的切片、腱索修复、眼袋成形术、瓣环成形术、放置新的瓣膜或将夹具附连,以将脱垂瓣叶的自由端联接至非脱垂瓣叶的自由端。然而,这些解决方案在功效、安全性或并发症的可能性、侵入性、通过瓣膜的血流的横截面积减小以及瓣膜可用于未来治疗方面具有显著的缺点。
因此,需要一种能够更容易地修复由于瓣叶脱垂而引起的反流的瓣膜的系统,该系统具有更高的功效和更少的并发症。进一步地,需要一种系统,该系统可以修复由于瓣叶脱垂而经受反流的瓣膜,同时使瓣膜可用于将来的治疗。
发明内容
本文的实施例涉及一种用于治疗心脏瓣膜中的瓣膜反流的系统。该系统包括柔性顶盖和细长系绳。细长系绳的近端附连于柔性顶盖的远端。柔性顶盖包括第一表面以及与第一表面相对的第二表面。细长系绳构造成在原位置于张力下,并且包括非弹性部分和至少与非弹性部分一样长的弹性部分。当系统处于部署构造时,柔性顶盖的近端锚定于心脏瓣膜的瓣环上,并且细长系绳的远端锚定于心室的组织,使得柔性顶盖的第一表面覆盖心脏瓣膜的第一瓣叶底下的第一表面。细长的系绳被置于张力下,使得该系统构造成防止心脏瓣膜的第一瓣叶张开,并允许柔性顶盖的第二表面的一部分与心脏瓣膜的第二瓣叶的相对的至少一部分合紧。
在本发明的另一种实施例中,该系统包括柔性顶盖和细长系绳。细长系绳的近端附连于柔性顶盖的远端。柔性顶盖包括第一表面以及与第一表面相对的第二表面。柔性顶盖是无支承的并且不包括附连于其的框架。细长系绳构造成在原位被置于张力下并且包括非弹性部分和弹性部分。当系统处于部署构造时,柔性顶盖的近端锚定于心脏瓣膜的瓣环上,并且细长系绳的远端锚定于心室的组织,使得柔性顶盖的第一表面覆盖心脏瓣膜的第一瓣叶底下的第一表面。细长系绳被置于张力下,使得该系统构造成防止心脏瓣膜的第一瓣叶张开,并允许柔性顶盖的第二表面的一部分与心脏瓣膜的第二瓣叶的相对的至少一部分合紧。
本发明的实施例还涉及治疗瓣膜反流的方法。该方法包括将处于递送构造的系统经皮递送至心脏瓣膜。该系统包括柔性顶盖和附连于柔性顶盖的远端的细长系绳。柔性顶盖是无支承的并且不包括联接于其的框架,并且细长系绳包括非弹性部以及至少与非弹性部分一样长的弹性部分。至少一个近侧锚定件嵌入到心脏瓣膜的瓣环中。柔性顶盖的近端联接于至少一个近侧锚定件。远侧锚定件嵌入到邻近心脏瓣膜的心室中。细长系绳的远端联接于远侧锚定件。张力施加在柔性顶盖上,使得柔性顶盖的第一表面覆盖心脏瓣膜的第一瓣叶底下的第一表面。检查心脏瓣膜是否反流。调节柔性顶盖上的张紧力,以使瓣膜反流最小化。
附图说明
从下面对实施例的描述中且如附图中所示的,本技术的前述和其它特征以及方面会被更好地理解。被纳入本文且构成申请文件的一部分的附图还用作示出本技术的原理。附图中的各部件不一定按比例绘制。
图1是具有天然瓣膜结构的哺乳动物心脏的示意性剖视图。
图2A是哺乳动物心脏的左心室的示意性剖视图,示出了解剖结构和天然二尖瓣。
图2B是具有脱垂的二尖瓣的心脏的左心室的示意性剖视图,其中瓣叶不充分合紧,且脱垂的二尖瓣适于经由根据本发明实施例的系统进行修复。
图2C是从不同角度观察的图2B的左心室的示意性剖视图。
图2D是图2B的脱垂二尖瓣的俯视图,其中二尖瓣处于打开构造。
图3A是根据本发明的实施例的用于治疗心脏瓣膜反流的系统的立体图。
图3B是图3A的系统和天然二尖瓣的前瓣叶的立体图。
图4是心脏的示意性剖视图,其中,图3A的系统以部署构造植入在心脏内,并且心脏的天然二尖瓣处于打开构造。
图5是心脏的示意性剖视图,其中,图3A的系统以部署构造植入在心脏内,并且心脏的天然二尖瓣处于闭合构造。
图6是图5的二尖瓣的俯视图,其中二尖瓣处于闭合构造。
图7A是根据本发明的另一种实施例的用于治疗心脏瓣膜反流的系统的立体图。
图7B是根据本发明的又一种实施例的用于治疗心脏瓣膜反流的系统的立体图。
图8是心脏的剖面剖视图,该图示出了使用根据本发明实施例的图3A的系统采用经中隔方法修复天然二尖瓣的脱垂后瓣叶的方法步骤,其中,图3A的系统示出为以递送构造而在定位于心脏左心房内的递送导管内。
图9是心脏的剖面剖视图,该图示出了使用图3A的系统修复天然二尖瓣的脱垂后瓣叶的方法步骤,其中,多个近侧锚定件部署成与天然二尖瓣的瓣环配合。
图10是心脏的剖面剖视图,该图示出了使用图3A的系统修复天然二尖瓣的脱垂后瓣叶的方法步骤,其中,系统的柔性顶盖的近端在天然二尖瓣的瓣环处联接于多个近侧锚定件。
图11是心脏的剖面剖视图,该图示出了使用图3A的系统修复天然二尖瓣的脱垂后瓣叶的方法步骤,其中,远侧锚定件部署成配合心脏的左心室中的组织。
图12是心脏的剖面剖视图,该图示出了使用图3A的系统修复天然二尖瓣的脱垂后瓣叶的方法步骤,其中,该系统的细长系绳的远端联接于左心室中的远侧锚定件。
图13是心脏的剖面剖视图,该图示出了使用图3A的系统修复天然二尖瓣脱垂的后瓣叶的方法步骤,其中,施加细长构件的张力,使得柔性顶盖覆盖天然二尖瓣的后瓣叶。
图14是心脏的剖面剖视图,该图示出了使用图3A的系统修复天然二尖瓣脱垂的后瓣叶的方法步骤,其中,调节细长系绳的张力,以使二尖瓣处的反流流最小化。
具体实施方式
现参照附图描述本发明的具体实施例,其中,相似的附图标记指示相同的或功能类似的元件。术语“远侧”和“近侧”在用于以下的描述中而涉及递送装置、递送系统或递送导管时是相对于有关治疗医师的位置或方向来使用。因此,“远侧”或“向远侧”是指远离治疗医师的位置或沿远离治疗医师的方向,并且术语“近侧”和“向近侧”是指靠近医师的位置或沿朝向医师的方向。术语“远侧”和“近侧”在以下描述中用于指示要植入血管的系统或装置、比如用于治疗心脏瓣膜反流的系统时,是参考来自心脏的血流方向来使用。因此,“远侧”或“向远侧”是指相对于血流方向位于下游方向中的位置,并且术语“近侧”和“向近侧”是指相对于血流方向位于上游方向中的位置。
以下的详细描述本质上仅是示例性的,而非意在限制本技术或对本技术的应用和使用。尽管在心脏瓣膜反流的治疗且特别是二尖瓣反流的治疗的背景下对本技术的实施例进行了描述,但本技术还可用于被认为有用的任何其它身体通路中。此外,不意在受在前所述技术领域、背景技术、发明内容或以下具体描述中呈现的任何明示或暗示的理论的约束。
现在将描述1-2D以提供关于瓣膜反流的内容信息。图1是哺乳动物心脏HE的剖视示意图,描绘了四个心腔(右心房RA、右心室RV、左心房LA、左心室LV)和天然瓣膜结构(三尖瓣TV、二尖瓣MV、肺动脉瓣PV、主动脉瓣AV)。图2A是哺乳动物心脏HE的左心室LV的示意性剖视图,示出了解剖结构和天然二尖瓣MV。同时参照图1和2A,心脏HE包括左心房LA,该左心房LA经由肺静脉接收来自肺的含氧血。在心室舒张期间,左心房LA将含氧血泵送通过二尖瓣MV并进入左心室LV。在收缩期间,左心室LV收缩,且血液向外流过主动脉瓣AV、进入主动脉并流至身体的其余部分。
在健康的心脏中,二尖瓣MV包括打开构造和闭合构造。当二尖瓣MV处于打开构造时,前瓣叶AL和后瓣叶PL不合紧,从而允许血液从右心房RA流向左心室LV。如图2A所示,当二尖瓣处于闭合构造时,天然二尖瓣MV的前瓣叶AL和后瓣叶PL在自由边缘处均匀地相碰或“合紧”而闭合,并防止血液在左心室LV的收缩期间血液回流到左心房LA中。前瓣叶AL和后瓣叶PL经由被称作瓣环AN的连接组织的致密纤维环附连至周围心脏结构,瓣环AN与前瓣叶AL和后瓣叶PL的组织以及心脏壁的邻接肌肉组织不同。一般而言,瓣环AN处的连接组织比瓣叶组织更纤维化、更强韧且更强健。天然二尖瓣MV的前瓣叶AL和后瓣叶PL的柔性组织经由被称为腱索CT的分支腱而连接于乳头肌PM,而乳头肌PM则从左心室LV的下壁和室间隔IVS向上延伸。
如图2B-2D所示,在心脏二尖瓣MV由于第一或后瓣叶PL和第二或前瓣叶AL脱垂而经受瓣膜反流的心脏HE中,后瓣叶PL和前瓣叶AL的相应边缘没有充分地合紧或相碰,并且将发生通过间隙GP从左心室LV到左心房LA的泄漏。若干结构性缺陷可引起二尖瓣叶LF脱垂,并随后发生反流,这些结构性缺陷包括破裂的腱索CT、乳头肌PM(例如由于缺血性心脏病)受损、以及心脏和/或二尖瓣膜瓣环AN的肿大(例如心肌病)。
参照图3A-14描述了根据本技术的系统和相关方法的实施例。将理解的是,本文中参照图3A-14所描述的实施例的特定元件、子结构、用途、优势和/或其它方面可与根据本技术的附加实施例彼此合适地交换、替代或以其它方式构造。
本文提供的系统和方法适合于修复心脏瓣膜的瓣叶以减少或消除瓣膜反流。更具体地,在本发明的实施例中,将系统的柔性顶盖放置在心脏瓣膜的现有天然瓣叶上,并用细长系绳张紧,以防止瓣叶脱垂以及因瓣叶脱垂而导致的随后的反流。该系统可通过细长系绳进行调节,以使系统最小化或消除瓣膜反流。进一步地,可在初始程序期间或在随后的一个或多个过程中重新调节该系统,以考虑天然解剖结构随时间的变化。本文所述的系统不减小或改变天然二尖瓣的横截面积,因此避免了流经心脏瓣膜的血液减少,并且仍允许容易地进入心脏瓣膜以用于将来的治疗和医治。
现在转向图3A,图3A是根据本发明的实施例构造的用于治疗由于瓣叶脱垂而引起的心脏瓣膜中的瓣膜反流的系统100的立体图。该系统100包括柔性顶盖102和细长系绳104。进一步地,系统100包括递送构造以及如图3A所示的部署构造,在递送构造中,系统被压缩以用于在递送导管内经皮递送至期望的治疗位置。当系统100处于递送构造时,柔性顶盖102可以被折叠、卷起或以其它方式压缩。基于多种特征来选择压缩柔性顶盖102的方法,这些特征包括但不限于锚定件固定或部署的顺序或次序。
如图3A所示,柔性顶盖102由柔性材料形成,并且包括近端106、与近端106相对的远端108、底侧或第一表面114以及与第一表面114相对的顶表面或第二表面116。柔性顶盖102可由将会通过生长而结合到脱垂的瓣叶上的材料形成,例如但不限于心包组织或其它合适的材料。柔性顶盖102的近端106构造成在心脏瓣膜的瓣环处或在瓣环上锚定就位。如本文中所使用的,在瓣环“处或上”是指在天然心脏瓣膜的瓣环的水平面处或在其上,包括在瓣膜的上表面的水平面或瓣膜的其它上水平面处或上的配置。进一步地,当系统100处于部署构造中时,柔性顶盖102构造成覆盖天然心脏瓣膜的脱垂的瓣叶的底下或隐蔽的部分,使得第一表面114邻抵或接触脱垂的瓣叶的底下部分,如以下更详细描述的那样。柔性顶盖102的柔性性质允许柔性顶盖102符合天然的脱垂瓣叶的形状,如图3B最佳所示。图3B示出了系统100,其柔性顶盖102覆盖并符合天然后瓣叶PL,并且柔性顶盖102与天然心脏瓣膜的天然前瓣叶AL合紧。如本文中所使用的,术语“符合”是指柔性顶盖102呈现天然的脱垂瓣叶的基础解剖结构的相同形状、外形或轮廓,使得柔性顶盖102与其相邻的天然脱垂瓣叶的叶保持一致且紧密的接触。这样,虽然图3A的柔性顶盖102示出为具有特定形状,但这是示例性的而非限制性的,并且应当理解的是,柔性顶盖102呈现或符合天然的脱垂瓣叶的形状。为了系统100,更具体地说是柔性顶盖102,需要这种顺应性,以防止当系统100处于部署构造时天然瓣叶脱垂,如以下更详细描述的。随着时间的流逝,由于柔性顶盖102的材料,柔性顶盖102的第一表面114结合或融合至脱垂瓣叶的第一表面。
在图3A的实施例中,柔性顶盖102的第一表面114包括多个微齿或微倒钩110,这些微齿或微倒钩构造成有助于将柔性顶盖102的第一表面114联接至天然脱垂瓣叶的第一表面。虽然在图3A中示出了具有三(3)个微倒钩110,但这是示例性的而不是限制性的,并且可使用更多或更少的微倒钩110。在一种实施例中,微倒钩110可具有在约0.005英寸至约0.010英寸之间的范围内的直径,并且微倒钩110的长度可在约0.010英寸至约0.100英寸之间的范围内。微倒钩110可成形为嵌入相邻表面,例如但不限于楔形形状,其中楔形的末端与相邻表面接触。在另一种实施例中,微倒钩110可以是一系列金属线材。
在图3A和3B所示的实施例中,柔性顶盖102是无支承的。换言之,在图3A和3B所示的实施例中,柔性顶盖102不包括支承框架,而仅由具有第一表面114和相对的第二表面116的柔性材料组成。如本文所用,“无支承”是指柔性顶盖沿其长度没有径向或纵向支承,并且没有附连于支架或框架结构。由于其无支承的性质,允许柔性顶盖102符合底下的瓣叶结构,并且对于周围的天然解剖结构是无创伤的。
可基于期望的瓣叶覆盖量、天然解剖结构的形状和/或期望的锚定位置来选择柔性顶盖102的尺寸和周长。如在图3B中最清楚地示出的,在其一种实施例中,柔性顶盖102具有长方形的形状,并且构造成覆盖天然心脏瓣膜的脱垂瓣叶,使得柔性顶盖的第一表面114基本上与天然心脏瓣膜的脱垂瓣叶的整个下表面(即,至少90%)接触。在另一种实施例中,柔性顶盖102构造成覆盖天然心脏瓣膜的脱垂瓣叶,使得柔性顶盖的第一表面114与天然心脏瓣膜的脱垂瓣叶的下表面的百分之四十至百分之九十(40-90%)接触。另外,虽然图3A和3B的柔性顶盖102示出为具有向远侧延伸特定距离的特定长度,但这是示例性的而非限制性的,并且将理解的是,可使用适合于治疗瓣膜反流的其它长度。更具体地,如图3B中最佳地示出的,在一实施例中,柔性顶盖102向远侧延伸超过天然后瓣叶PL的远端。然而,在替代实施例中,柔性顶盖102不延伸超过后瓣叶PL的脱垂部分。将理解的是,柔性顶盖102的形状和尺寸可呈现任何和所有可能的排列,包括但不限于跨过大部分天然脱垂瓣叶、刚好越过天然脱垂瓣叶的脱垂部分的柔性顶盖102或适用于本文所述目的的任何其它构造。
现在将参照图3A更详细地描述细长系绳104。细长系绳104具有第一长度L1,该第一长度从其附连于柔性顶盖102的远端108的近端120延伸至其远端122。细长系绳104的近端120可通过包括但不限于粘合剂、绑扎、缝合、机械装置、熔合或适合于本文所述目的的任何其它方法的方法联接至柔性顶盖102的远端108。细长系绳104包括联接于非弹性部分126的弹性部分124。弹性部124是具有弹性的细长构件。如本文所使用的,“弹性的”是指细长构件在变形之后返回或能够恢复其原始长度或形状。弹性部分124可由弹性材料形成,比如但不限于诸如硅酮、戈尔、或任何其它合适材料的假体腱索材料。当系统100在原位处于部署构造时,弹性部分124构造成允许柔性顶盖102的动态运动。非弹性部分126是具有非弹性特性的细长构件。如在本文中所使用的,“非弹性”是指细长构件126不是弹性的并且不能被拉伸。非弹性部分126可由非弹性材料形成,例如但不限于诸如聚丙烯之类的单丝或塑料缝线材料、诸如不锈钢、钛或镍钛合金(即NITINOL)之类的金属合金、或任何其它合适的材料。
细长系绳104是连续的,或者换言之,弹性部分124和非弹性部分126共同形成细长系绳104。弹性部分124包括近端128和远端130,而非弹性部分126包括近端132和远端134。在图3-6的实施例中,弹性部分124配置在非弹性部分126的近侧。更具体地,弹性部分124的近端128联接于柔性顶盖102的远端108,并且弹性部分124的远端130联接于非弹性部分126的近端132。非弹性部分126的近端132可以通过包括但不限于粘合剂、绑扎、缝合、机械装置、熔合或适合于本文所述目的的任何其它方法的方法联接至弹性部分124的远端130。基于多种特征来选择弹性部分124与非弹性部分126相对于细长系绳104的第一长度L1的比率,这些特征包括但不限于天然瓣膜位置、天然解剖结构以及系统100的特征和几何形状。在本发明的实施例中,如图3A和3B所示,弹性部分124比非弹性部分126长,以确保允许柔性顶盖102的动态运动。例如,弹性部分124与细长系绳104的非弹性部分126的比率可以是50/50、60/40、70/30,或者被发现适于修复瓣膜反流的其它比率。
细长系绳104的远端122联接于远侧锚定件(图3A中未示出),该远侧锚定件锚定在与脱垂瓣膜相邻的心室中。细长系绳104构造成,当系统100处于部署构造并在原位植入时被置于张力中,如以下更详细地描述的。当被置于张力中时,细长系绳104如方向箭头150所示沿远侧方向牵拉柔性顶盖102的远端108。换言之,当细长系绳104在植入期间被置于张力中时,细长系绳104将柔性顶盖102置于张力中。进一步地,细长系绳104上的张力构造成在原位可调节,以调节或调整柔性顶盖102的曲率和/或柔性顶盖102与心脏瓣膜的非脱垂瓣叶或瓣叶合紧的角度,以最小化或减少反流。当施加至细长系绳104的张力增加时,细长系绳104的弹性部分124拉伸或伸长,并且细长系绳104的第一长度L1相对增加。相反地,当施加至细长系绳104的张力减小时,细长系绳104的弹性部分124缩短,并且细长系绳104的第一长度L1相对减小。下面参照图4,将更详细地讨论用于将细长系绳104置于张力中的装置和方法。
现在将参照图4-6描述系统100的部件的相互作用。图4和图5是植入心脏HE内的部署构造中的系统100的示意性剖视图,其中图4示出了心脏的处于打开构造的天然二尖瓣MV,图5示出了心脏HE的处于闭合构造的天然二尖瓣MV。图6是心脏HE的处于闭合构造的天然二尖瓣MV的俯视图。在图4-6中,血流方向由箭头BF表示。系统100构造成修复二尖瓣MV的脱垂的后瓣叶PL。更具体地,当系统100处于部署构造并植入心脏HE内时,柔性顶盖102的近端106通过至少一个近侧锚定件136锚定或联接于二尖瓣MV的瓣环AN。柔性顶盖102的第一表面114覆盖二尖瓣MV的第一或后瓣叶PL的底下的第一表面并与该第一表面接触。细长系绳104从柔性顶盖102的远端108延伸至左心室LV中的远侧锚定件138。
近侧锚定件136和远侧锚定件138可以是适于分别嵌入到瓣环AN和左心室LV的组织中的任何锚定件,包括但不限于螺旋形螺钉或锚定件、倒钩或夹具。在图4和5所示的实施例中,近侧锚定件136和远侧锚定件138中的每一个被显示为螺旋形螺钉或锚定件、。每个螺旋形锚定件136、138可通过递送导管的对应的可释放轴而旋转,以将相应的螺旋形锚定件嵌入心肌组织中。例如而非限制性地,近侧锚定件136和远侧锚定件138可以是如授予Kane的美国专利第3,974,834号或授予Rose的美国专利第4,046,151号中所描述的锚定件,两篇文献中的每一个都被转让给本发明的同一受让人,并且每篇文献全文以参见的方式纳入本文。虽然在本文中被描述为螺旋形锚定件136、138,但这是示例性的而非限制性的,并且近侧锚定件136和远侧锚定件138的形状可具有其它形状和其他递送方法。例如而非限制性地,近侧锚定件136和/或远侧锚定件138可以是如授予Peters的美国专利第4,341,226号或授予Grubac等人的美国专利第9,775,982号中所描述的锚定件,两篇文献中的每一个都被转让给本发明的同一受让人,并且每篇文献全文以参见的方式纳入本文。
如上所述,当系统100处于部署构造并如图4所示地在原位植入时,细长系绳104被置于张力中,以便使柔性顶盖102正确地定位以覆盖二尖瓣MV的第一或后瓣叶PL的底下的第一表面。在本发明的一实施例中,细长系绳104的远端122预先附连于远侧定件138,并且细长系绳104通过以向细长系绳104提供张力的方式将远侧锚定件138附连至左心室LV而被置于张力中。更具体地,通过改变远侧锚定件138前进或嵌入左心室LV的壁中的量来向细长系绳104提供张力。例如,当远侧锚定件138是如图所示的螺旋形螺钉时,远侧锚定件138可以更大量或更大距离地拧入左心室LV的壁中,以增加施加至细长系绳104的张力。相反地,如果期望,则可松开远侧锚定件138,以减小施加至细长系绳104的张力。在本发明的另一种实施例中,细长系绳104的远端122预先附连于远侧锚定件138,并且通过改变细长系绳104从柔性顶盖102延伸的角度,使细长系绳104置于张力中。更具体地,远侧锚定件138的位置可移动,以增加或减小细长的系绳104从柔性顶盖102延伸的角度。例如,远侧锚定件138的位置可朝向左心室LV的顶点AP运动,以增加施加至细长系绳104的张力。相反地,远侧锚定件138的位置可朝向左心室LV的心室间隔IVS运动,以减小施加至细长系绳104的张力。
在本发明的另一种实施例中,细长系绳104构造成经由张紧装置或张紧器(未示出)而被置于张力中。例如,如O'Bierne等人的美国专利No.9,452,048中所描述的,已转让给本发明的同一受让人的张紧装置可被修改并用作张紧装置或张紧器,其全文以参见的方式纳入本文。例如,细长系绳104可以最初经由细长系绳104的整体环可滑动地联接于远侧锚定件138,使得细长系绳104的自由端向近侧延伸穿过递送导管,并且是医师可触及的。在将远侧锚定件138固定至心室壁之后,医师可在细长系绳104的可触及的自由端上牵拉,以有效地减小细长的系绳104的第一长度L1,并进一步有效地增加施加在细长系绳104上的张力。相反地,医师可释放或推动细长的系绳104的自由端以有效地在原位增加细长系绳104的第一长度L1,并进一步有效地减小置于细长系绳104的张力。一旦使张力最佳,就可以在细长系绳104的自由端上并通过输送导管滑动或推进如先前以参见的方式纳入本文的O'Bierne等人的美国专利9,452,048中所述的锁定机构,直到锁定机构邻抵远侧锚定件138,从而确保将细长系绳104置于所期望量的张力下。细长系绳104的任何多余的长度、即从锁定机构延伸至向近侧延伸回到医师的自由端的系绳的长度,都可被切割并从患者体内移除。张紧装置在本文中已经通过示例而非限制的方式进行了描述。将理解的是,张紧装置可以是任何合适的装置,其构造成允许将细长的系绳104置于张力中,并且更具体地,如上所述,调节或改变细长系绳104的第一长度L1以增加或减小施加在细长系绳104上的张力。
无论使用哪种方法或装置将细长系绳104置于张力中,在调整置于细长系绳104上的张力的期间,细长系绳104的第一长度L1都发生变化。因此,当减小细长系绳104的第一长度L1以增加施加在细长系绳104上的张力时,其弹性部分124被拉伸。由于弹性部分124期望返回其静止形状或长度,因此弹性部分124被置于弹簧张力中。该弹簧张力作为张紧力传递至相邻联接部件。更精确地,弹簧张力在非弹性部分126的近端132上进行牵拉,并通过非弹性部分126传递至细长系绳104的的远端122,该远端122利用第一张紧力由远侧锚定件138锚定至左心室LV,第一张紧力由图5所示的方向箭头TF1表示。此外,弹簧张力在柔性顶盖102的远端108上进行牵拉,并通过柔性顶盖102传递至柔性顶盖102的近端106,该近端106利用第二张紧力由至少一个近侧锚定件136锚定在瓣环AN处,第二张紧力由图5所示的方向箭头TF2表示。为了本文描述的目的,远侧锚定件138和至少一个近侧锚定件136相对于系统100是固定的。将理解的是,第一张紧力TF1和第二张紧力TF2相等且相反。利用足够的张紧力将柔性顶盖102的远端108沿箭头TF2的方向牵拉,使得柔性顶盖102、或更确切地说其第一表面114放置成与后瓣叶PL的底下的第一表面接触,从而防止后瓣叶PL脱垂。进一步地,可调节在柔性顶盖102上的张紧力以优化柔性顶盖102与心脏瓣膜的第二瓣叶的合紧,并且使瓣膜反流最小化。换言之,细长系绳104上的张力是可调节的,以使柔性顶盖102的第二表面116的一部分与二尖瓣MV的前瓣叶AL的相对匹配部分的合紧最大化,并最小化或消除二尖瓣MV的反流。
尽管在图6中示出了在特定位置具有三个近侧锚定件136,但这是示例性的而非限制性的。将理解的是,可以使用更多或更少的近侧锚定件136,并且(一个或多个)近侧锚定件136可配置在其它位置处。进一步地,尽管在图5中将远侧锚定件138示出为配置在左心室LV的顶点AP处,但是这也是示例性的而非限制性的。远侧锚定件138可配置在左心室LV内的任何位置处,以优化柔性顶盖102与前瓣叶AL的合紧表面之间的角度。例如,远侧锚定件138可配置在左心室LV内的任何位置处,包括但不限于心尖AP、心室壁、室间隔IVS或乳头肌PM。
图7A是根据本发明的另一种实施例构造的用于治疗由于瓣叶脱垂而引起的心脏瓣膜中的反流的系统200的立体图。系统200包括柔性顶盖202和细长系绳204,细长系绳204包括弹性部分224和非弹性部分226。在图7A的实施例中,柔性顶盖202包括框架242,并且细长系绳204具有相对于上述细长系绳104的替代构造。
如图7A所示,柔性顶盖202由柔性材料形成,并且类似于先前描述的柔性顶盖102。因此,将不再重复柔性顶盖202的构造和材料的类似细节。然而,柔性顶盖202由联接于柔性顶盖202的材料的框架242支承。框架242配置在柔性顶盖202的近侧部分248处。在图7A的实施例中,框架242具有D形构造,并且框架242的第一或弯曲端部244邻近柔性顶盖202的近端206配置。框架242与柔性顶盖202的周界相邻地配置,并且框架242还大致遵循柔性顶盖202的周界的形状。然而,这并不意味着是限制性的,并且将理解的是,框架242可配置在柔性顶盖202的任何位置处。在本文的实施例中,框架242构造成向柔性顶盖202的近侧部分248提供结构支承。进一步地,当系统200处于部署构造且心脏瓣膜处于闭合构造时,框架242用于维持柔性顶盖202与心脏瓣膜的非脱垂瓣叶之间的合紧角。虽然以特定形状示出,但是框架242可具有其它形状,包括但不限于椭圆、圆形或适合于本文所述目的的任何其它形状。进一步地,框架242的实施例可包括附加的支柱或其它加强构件。框架242可由以下材料形成:诸如但不限于镍钛合金(例如镍钛诺)、不锈钢或其它合适材料。框架242可缝合到柔性顶盖202中,或者可通过任何其它合适的方法联接于柔性顶盖202。在一实施例中,框架242附连于多个近侧锚定件236。
在图7A的实施例中,框架242构造成当系统200在原位处于部署构造时仅配置在天然二尖瓣的心房侧上。当框架242仅设置在天然二尖瓣的心房侧上时,允许柔性顶盖202在左心室内具有增加的柔性。进一步地,在框架242仅配置在天然二尖瓣的心房侧上的情况下,在左心室LV内没有框架242的相对刚性或刚硬的元件,而这样的元件可能损坏左心室LV内的腱索或其它天然解剖结构。在替代实施例中,框架242可向远侧延伸到相邻的心室中。
图7A的细长系绳204类似于图3A的细长系绳104,除了弹性部分224和非弹性部分226的构造或布置分别与图3A所示的细长系绳104的构造相反。更具体地,在图7A的实施例中,弹性部分224配置在非弹性部分226的远侧。弹性部分224包括近端228和远端230。在图7A的实施例中,弹性部分224是螺旋弹簧。如同图3A的弹性部分124一样,弹性部分224构造成在柔性顶盖202上施加拉力,如先前参照图3A的弹性部分124所描述的,因此,不再参照图7A详细描述。
图7A的细长系绳204的非弹性部分226的构造包括联接于柔性顶盖202的远端208的近端232、非弹性部分226的联接于弹性部分224的近端230的远端234、以及弹性部分224的联接于心室的远端230,如先前关于图4-6的远端134所描述的。尽管非弹性部分226和弹性部分224与图3A的细长系绳104的弹性部分124和非弹性部分126相比定位在细长系绳204的相对端处,但将理解的是,在柔性顶盖202上施加和调节张力类似地通过延长或缩短细长系绳204的长度来实现。
虽然在本文中描述有一(1)个弹簧弹性部分224,但是在替代实施例中,如图7B所示,细长系绳204’包括分别配置在非弹性部分226’的近端232’和远端234’处的两(2)个弹簧弹性部分224a和224b。两个弹簧弹性部分224a和224b帮助确保允许柔性顶盖202在原位的动态运动。
图8-14是心脏HE的剖面剖视图,示出了根据本发明的实施例的经由用于递送和部署图3的系统100的经中隔途径在二尖瓣MV处治疗反流的方法步骤。至二尖瓣MV的通路可通过患者的脉管结构以经皮方式实现。在一定实施例中,至二尖瓣的途径是顺行的且可经由通过跨过房间隔而进入左心房来实现。如本领域中已知的,导丝(未示出)可通过使用任意数量的技术在血管中前进,例如通过下静脉腔或上静脉腔(图1)、通过房间隔(未示出)中的穿刺孔切口进入右心房RA并进入左心房LA(图1)。引导导管(未示出)可沿导丝前进并进入右心房RA、穿过房间隔中的穿刺孔并进入左心房LA。引导导管可具有预成形或可转向的远端,以使引导导管成形或转向,使得其将递送导管朝向二尖瓣MV引导。
替代地,还可经由经心房途径、例如直接通过左心房LA中的切口而通至二尖瓣。至心脏的通路可通过胸腔中的肋间切口来获得而无需移除肋,且引导导管(未示出)可通过用荷包线缝线密封的心房切口而放置入左心房LA中。递送导管可接着经引导导管前进至二尖瓣。替代地,递送导管可包括导丝内腔,使得其可在导丝上被追踪,并且可直接穿过心房切口放置而不使用引导导管。
参照图8,递送导管301的远侧部段303被显示为定位在左心房LA中。递送导管301通过脉管系统递送到左心房LA中,其中系统100处于递送构造,在递送构造中,系统100被径向压缩并配置在递送导管301的远侧部段303内。经由股动脉、肱动脉、桡动脉或腋动脉中的经皮进入部位可实现进入右心房RA的血管内通路。如本领域技术人员将理解的,手柄部件(在图8-14中不可见)以及递送导管301的近侧部段的一段长度暴露于患者的外部,以供医师触及。通过从脉管系统外部操纵递送导管301的手柄,医师可使递送导管301的远侧部段303前进并远程操纵远侧部段116,并且使远侧部段116转向而通过有时曲折的血管内路径。递送导管301的远侧部段303可向远侧前进到左心房LA中,并且大致定位在二尖瓣MV上方(例如,上游)以将系统100递送至二尖瓣MV。
在图9中所示的下一递送步骤中,三个近侧锚定件136在二尖瓣MV的瓣环AN处嵌入组织中。每个近侧锚定件136在瓣环AN处的嵌入可通过本领域技术人员所理解的各种方法来完成。例如但不限于,每个近侧锚定件136可以是螺旋形锚定件,其由递送导管301的相应的近侧锚定轴305旋转,以将每个近侧锚定件136嵌入到瓣环AN处的组织中。每个近侧锚定轴305可以是例如在美国专利第3,974,834号或美国专利第4,046,151号中所描述的轴、杆或导杆,这些专利中的每一个先前均以参见的方式本文。一旦每个近侧锚定件136嵌在瓣环AN处,近侧锚定件136就从相应的近侧锚定轴305释放。
在图9的实施例中,每个近侧锚定件136在与递送导管301一起递送之前预先附连于柔性顶盖102。因此,一旦近侧锚定件136被嵌入在瓣环AN处并且每个近侧锚定件136从相应的近侧锚定轴305释放,则柔性顶盖102的近端106在瓣环AN处保持附连于每个近侧锚定件136,如图10所示。近端106附连于多个近侧锚定件136,以将柔性顶盖102的近端106有效地锚定或固定至天然二尖瓣MV的瓣环AN。
虽然在本文中描述了柔性顶盖102在通过递送导管301递送之前预先附连于多个近侧锚定件136,但这是示例性的而非限制性的。将理解的是,在每个近侧锚定件136已经嵌入在天然二尖瓣MV的瓣环AN处之后,柔性顶盖102能够替代地联接于多个近侧锚定件136。例如而非限制性地,柔性顶盖102可包括附连于其的多个孔眼,每个近侧锚定轴305配置成穿过对应的孔眼。柔性顶盖102可通过推轴或其它装置自递送导管301部署,并且每个孔眼和柔性顶盖102沿着相应的多个近侧锚定轴305向远侧滑动,以联接至对应的近侧锚定件136。一旦柔性顶盖102联接于多个近侧锚定件136,就通过相应的近侧锚定轴305释放每个近侧锚定件136。
如图11所示,在下一步中,远侧锚定件138通过远侧锚定轴307嵌入左心室LV内的组织中。远侧锚定件138的嵌入可通过本领域技术人员所理解的各种方法来实现。例如而非限制性地,远侧锚定件138可以是螺旋形锚定件,其由远侧锚定轴307旋转以将远侧锚定件138嵌入左心室LV的顶点AP中。每个远侧锚定轴307可以是例如在转让给美敦力公司(Medtronic,Inc.)的美国专利第3,974,834号或美国专利第4,046,151号中所描述的轴、杆或导杆,这些专利中的每一个先前都以参见的方式纳入本文。虽然在图5中远侧锚定件138示出为在顶点AP处嵌入到组织中,但是这是示例性的而非限制性的。如前所述,可基于柔性顶盖102相对于前瓣叶AL的角度来确定左心室LV中远侧锚定件138的位置,以实现柔性顶盖102与前瓣叶AL之间的最佳合紧,以最小化或消除反流。一旦远侧锚定件138嵌入左心室LV的期望位置,则远侧锚定件138从远侧锚定轴307释放。
在图11的实施例中,远侧锚定件138在与递送导管301一起递送之前预先附连于细长系绳104。因此,一旦远侧锚定件138嵌入左心室LV中并且远侧锚定件138从远侧锚定轴307释放,则细长系绳104的远端122附连于远侧锚定件138,如图12所示。远端122附连于远侧锚定件138以有效地将细长系绳104的远端122固定或锚定至左心室LV。
尽管已经将细长系绳104描述为在由递送导管301递送之前联接于远侧锚定件138,但是这是示例性的而非限制性的。将理解的是,在远侧锚定件138已嵌入左心室LV中之后,细长系绳104能够替代地被单独地递送并联接于远侧锚定件138。例如而非限制性地,细长系绳104可在远端122处包括孔眼,其中远侧锚定轴307配置成穿过细长系绳104的孔眼。细长系绳104可以通过推轴或其它装置自递送导管301部署,并且每个孔眼和细长系绳104沿着远侧锚定轴307向远侧滑动,以将细长系绳104的孔眼联接至远侧锚定件138。一旦细长系绳104联接于远侧锚定件138,远侧锚定件138就由远侧锚定轴307释放。
当柔性顶盖102的近端106联接于瓣环AN并且细长系绳104的远端122联接于左心室LV,而柔性顶盖102覆盖后瓣叶PL时,如以上参照图4和5所述地施加和/或调节张力以在柔性顶盖102上施加张力。更确切地,如以上更详细地描述的,细长系绳104的弹性部分124处于弹簧张力下,并且弹性部分124上的弹簧张力作为如箭头TF2所示的第二张紧力TF2传递至柔性顶盖102的远端108。柔性顶盖102上的第二张紧力TF2防止后瓣叶PL脱垂,并确保柔性顶盖102与前瓣叶AL的合紧,如图13所示。
在下一步中,检查二尖瓣MV的瓣膜反流。检查二尖瓣MV的反流可通过各种方法实现,包括但不限于超声心动图,以可视化柔性顶盖102的放置和二尖瓣MV的后瓣叶PL的脱垂。因此,可将回声涂层施加至系统100的一个或多个整体部分以协助可视化。当检查二尖瓣MV的瓣膜反流时,治疗医师还可调节柔性顶盖102上的张紧力,以使瓣膜反流最小化并优化柔性顶盖102与前瓣叶AL的合紧,如图14所示。可重复检查瓣膜反流和重新调节柔性顶盖102上的张紧力的步骤,以优化所修复的二尖瓣MV的性能。在二尖瓣假体101A于二尖瓣MV(或其它期望的瓣膜位置)处递送、部署和调节之后,可将递送导管301和剩余的导丝(如果有的话)从心脏10中移除并离开患者的身体。
图像引导、增强的回声性或其它方法可用于帮助医师递送和定位系统100。可使用影像导引来辅助医师对系统100在目标天然瓣膜区域处的定位和操纵,影响导引例如是心腔内超声心动图(ICE)、荧光镜检查、计算机断层扫描(CT)、血管内超声(IVUS)、光学相干断层扫描(OCT)或另一种合适的引导方式,或其组合。例如,这样的图像引导技术可以用于帮助确定柔性顶盖102相对于底下的脱垂天然瓣叶的定位。在一些实施例中,图像引导部件(例如,IVUS、OCT)可以联接于递送导管301、引导导管或两者的远侧部分,以提供目标心脏瓣膜区域近侧的区域的三维图像,从而有助于在心脏瓣膜区域内定位、定向和/或部署系统100。因此,可将回声涂层施加至系统100的各部件以协助可视化。
上述用于在患者的天然心脏瓣膜内递送和部署系统的实施例的各种方法步骤还可互换,以形成本技术的附加实施例。例如,尽管上述方法步骤以给定顺序呈现,但替代的实施例可以不同顺序执行各步骤。本文中描述的各种实施例还可结合以提供其它实施例。
此外,虽然上述递送导管作为适合于使用经中隔方法将系统的实施例递送至天然二尖瓣来讨论,但应当理解的是,递送导管还可适于用于修理其它心脏瓣膜(例如,肺动脉瓣、三尖瓣等)的递送系统,并可适于利用其它方法(例如,逆行、顺行)。适用于本文所述的系统和方法的实施例的递送导管的各种布置还可用于在体腔内递送其它治疗或医疗工具。
尽管以上已描述了各种实施例,但应理解,它们仅作为对本发明的示例而非作为限制而呈现。对相关领域技术人员显而易见的是,可从中做出各种形式上和细节上的变化而不偏离本技术的精神和范围。因而,本技术的广度和范围不应由上述实施例中的任一者限制,而是仅应根据所附权利要求和其等同形式被限定。还应当理解的是,本文中论述的每个实施例和本文中所引用的每篇参考文献的每个特征都可与任何其它实施例的特征组合使用。本文中论述的所有专利和公布文献都全文以参见的方式纳入本文。
Claims (21)
1.一种用于治疗心脏瓣膜中的瓣膜反流的系统(100、200),所述系统(100、200)包括递送构造和部署构造,所述系统(100、200)包括:
柔性顶盖(102、202),所述柔性顶盖包括第一表面(114)以及与所述第一表面(114)相对的第二表面(116);以及
细长系绳(104、204),所述细长系绳构造成在原位被置于张力下,所述细长系绳(104、204)包括弹性部分(124、224)以及联接于所述弹性部分(124、224)的非弹性部分(126、226),其中,所述弹性部分(124、224)与所述非弹性部分(126、226)至少一样长,并且所述细长系绳(104、204)的近端(120)附连于所述柔性顶盖(102、202)的远端(108、208),
其中,当所述系统(100、200)处于所述部署构造时,所述柔性顶盖(102、202)的近端(106、206)锚定至心脏瓣膜的瓣环,并且所述细长系绳(104、204)的远端(122)锚定至心室组织,使得所述柔性顶盖(102、202)的所述第一表面(114)覆盖所述心脏瓣膜的第一瓣叶的底下的第一表面,并且所述细长系绳(104、204)被置于张力下,使得所述系统(100、200)构造成防止心脏瓣膜的第一瓣叶脱垂,并允许所述柔性顶盖(102、202)的所述第二表面(116)的一部分与所述心脏瓣膜的第二瓣叶的至少相对的匹配部分合紧。
2.如权利要求1所述的系统(100、200),其特征在于,当所述柔性顶盖(102、202)的所述第一表面(114)覆盖所述心脏瓣膜的所述第一瓣叶时,所述柔性顶篷(102、202)的所述第一表面(114)基本上与所述心脏瓣膜的所述第一瓣叶的所述底下的第一表面的百分之四十至百分之九十之间相接触。
3.如权利要求1所述的系统(100、200),其特征在于,所述柔性顶盖(102、202)的所述第一表面(114)包括至少一个微倒钩(110),并且所述至少一个微倒钩(110)构造成将所述柔性顶盖(102、202)的所述第一表面(114)联接至所述心脏瓣膜的所述第一瓣叶的所述底下的第一表面。
4.如权利要求1所述的系统(100、200),其特征在于,当所述系统(100、200)处于所述部署构造时,所述柔性顶盖(102、202)不延伸到所述心室中。
5.如权利要求1所述的系统(100、200),其特征在于,所述细长系绳(104、204)的所述非弹性部分(126、226)定位在所述细长系绳(104、204)的所述弹性部分(124、224)的远侧。
6.如权利要求1所述的系统(100、200),其特征在于,所述细长系绳(104、204)的所述弹性部分(124、224)定位在所述细长系绳(104、204)的所述非弹性部分(126、226)的远侧。
7.如权利要求1所述的系统(100、200),其特征在于,所述细长系绳(104、204)的所述弹性部分(124、224)比所述细长系绳(104、204)的所述非弹性部分(126、226)更长。
8.如权利要求1所述的系统(100、200),其特征在于,所述细长系绳(104、204)的所述弹性部分(124、224)是弹簧。
9.如权利要求1所述的系统(100、200),其特征在于,还包括:框架(242),所述框架联接于所述柔性顶盖(102、202)的一部分。
10.如权利要求9所述的系统(100、200),其特征在于,当所述系统(100、200)处于所述部署构造时,所述框架(242)不延伸到所述心室中。
11.如权利要求1所述的系统(100、200),其特征在于,所述柔性顶盖(102、202)是无支承的并且不包括联接于其的框架。
12.如权利要求1所述的系统(100、200),其特征在于,当所述系统(100、200)处于所述部署构造时,所述柔性顶盖(102、202)延伸到所述心室中。
13.一种用于治疗心脏瓣膜中的瓣膜反流的系统(100、200),所述系统(100、200)包括递送构造和部署构造,所述系统(100、200)包括:
柔性顶盖(102、202),所述柔性顶盖包括第一表面(114)以及与所述第一表面(114)相对的第二表面(116),其中所述柔性顶盖(102、202)是无支承的并且不包括联接于其的框架;以及
细长系绳(104、204),所述细长系绳构造成在原位被置于张力下,所述细长系绳(104、204)包括弹性部分(124、224)以及联接于所述弹性部分(124、224)的非弹性部分(126、226),其中,所述细长系绳(104、204)的近端(120)附连于所述柔性顶盖(102、202)的远端(108、208),
其中,当所述系统(100、200)处于所述部署构造时,所述柔性顶盖(102、202)的近端(106、206)锚定至心脏瓣膜的瓣环,并且所述细长系绳(104、204)的远端(122)锚定至心室组织,使得所述柔性顶盖(102、202)的所述第一表面(114)覆盖所述心脏瓣膜的第一瓣叶的底下的第一表面,并且所述细长系绳(104、204)被置于张力下,使得所述系统(100、200)构造成防止心脏瓣膜的第一瓣叶脱垂,并允许所述柔性顶盖(102、202)的所述第二表面(116)的一部分与所述心脏瓣膜的第二瓣叶的至少相对的匹配部分合紧。
14.如权利要求13所述的系统(100、200),其特征在于,当所述柔性顶盖(102、202)的所述第一表面(114)覆盖所述心脏瓣膜的所述第一瓣叶时,所述柔性顶篷(102、202)的所述第一表面(114)基本上与所述心脏瓣膜的所述第一瓣叶的所述底下的第一表面的百分之四十至百分之九十之间相接触。
15.如权利要求13所述的系统(100、200),其特征在于,所述柔性顶盖(102、202)的所述第一表面(114)包括至少一个微齿(110),并且所述至少一个微齿(110)构造成将所述柔性顶盖(102、202)的所述第一表面(114)联接至所述心脏瓣膜的所述第一小叶的所述底下的第一表面。
16.如权利要求13所述的系统(100、200),其特征在于,当所述系统(100、200)处于所述部署构造时,所述柔性顶盖(102、202)不延伸到所述心室中。
17.如权利要求13所述的系统(100、200),其特征在于,当所述系统(100、200)处于所述部署构造时,所述柔性顶盖(102、202)延伸到所述心室中。
18.如权利要求13所述的系统(100、200),其特征在于,所述细长系绳(104、204)的所述非弹性部分(126、226)定位在所述细长系绳(104、204)的所述弹性部分(124、224)的远侧。
19.如权利要求13所述的系统(100、200),其特征在于,所述细长系绳(104、204)的所述弹性部分(124、224)定位在所述细长系绳(104、204)的所述非弹性部分(126、226)的远侧。
20.如权利要求13所述的系统(100、200),其特征在于,所述细长系绳(104、204)的所述弹性部分(124、224)比所述细长系绳(104、204)的所述非弹性部分(126、226)更长。
21.如权利要求13所述的系统(100、200),其特征在于,所述细长系绳(104、204)的所述弹性部分(124、224)是弹簧。
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US20210290390A1 (en) | 2021-09-23 |
US11026791B2 (en) | 2021-06-08 |
US11701228B2 (en) | 2023-07-18 |
CN111885982B (zh) | 2024-08-06 |
WO2019182939A1 (en) | 2019-09-26 |
EP3768195A1 (en) | 2021-01-27 |
US20190290431A1 (en) | 2019-09-26 |
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