CN107750150B - 用于递送、重新定位和收回经导管假体瓣膜的装置和方法 - Google Patents
用于递送、重新定位和收回经导管假体瓣膜的装置和方法 Download PDFInfo
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Abstract
本文描述了用于将假体二尖瓣递送和部署到心脏中的装置和方法。在一些实施例中,一种装置包括导管组件/瓣膜保持管和手柄组件。瓣膜保持管能够可释放地联接到导管组件的近端部分和手柄组件的远端部分。手柄组件包括壳体和递送杆。递送杆配置成被致动以相对于壳体朝远侧移动,从而将布置在瓣膜保持管内的假体心脏瓣膜移出瓣膜保持管并且在导管组件的长形鞘的管腔内朝远侧移动。导管组件配置成被致动以相对于壳体朝近侧移动,使得假体瓣膜被布置在长形鞘的管腔的外部。
Description
相关申请的交叉引用
本申请要求于2015年4月16日提交的、发明名称为“用于递送、重新定位和收回经导管假体瓣膜的装置和方法(Apparatus and Methods for Delivery,Repositioning,andRetrieval of Transcatheter Prosthetic Valves)”的美国临时专利申请第62/148,579号的优先权和权益,其公开内容通过引用整体并入本文。本申请也要求于2016年3月23日提交的、发明个名称为“用于递送、重新定位和收回经导管假体瓣膜的装置和方法(Apparatusand Methods for Delivery,Repositioning,and Retrieval of TranscatheterProsthetic Valves)”的美国临时专利申请第62/312,136号的优先权和权益,其公开内容通过引用整体并入本文。
技术领域
本文描述的实施例涉及用于经导管假体心脏瓣膜的递送、部署、重新定位和收回的装置和方法。
背景技术
假体心脏瓣膜会对心脏内的递送和部署构成特别的挑战。瓣膜性心脏病(具体地,主动脉瓣和二尖瓣疾病)是美国(US)的重大健康问题;在美国每年大约进行90,000次瓣膜置换。涉及心脏瓣膜的原位置换(orthotopic replacement)的常规瓣膜置换手术被认为是“心内直视(open heart)”外科程序。简而言之,该程序必须手术打开胸部,用心肺机启动体外循环,停止和打开心脏,切除和置换患病瓣膜,并且重启心脏。尽管瓣膜置换手术典型地在其他方面健康的人中具有1-4%的死亡率风险,但主要是由于必须进行体外循环,因此与该程序相关联的发病率明显更高。此外,心内直视手术在老年患者中往往耐受性差。因此消除该程序的体外部分能够导致发病率的下减,并且瓣膜置换疗法的成本可以显著降低。
尽管以经导管方式置换主动脉瓣是主要的研究对象,但是对二尖瓣的关注较少。这部分地反映了与原生二尖瓣装置相关联的更高水平的复杂性,以及因此,关于插入和锚固置换假体的更高水平的难度。因此,对用于经导管心脏瓣膜置换的递送装置和方法存在需求。也需要用于重新定位和/或收回所部署的假体心脏瓣膜的装置和方法。
发明内容
本文描述了用于将假体二尖瓣递送和部署到心脏中的装置和方法。在一些实施例中,一种装置包括导管组件、瓣膜保持管和手柄组件。所述瓣膜保持管能够可释放地联接到所述导管组件的近端部分和所述手柄组件的远端部分。所述手柄组件包括壳体和递送杆。所述递送杆配置成被致动以相对于所述壳体朝远侧移动,从而将布置在所述瓣膜保持管内的假体心脏瓣膜移出所述瓣膜保持管并且在所述导管组件的长形鞘的管腔内朝远侧移动。所述导管组件配置成被致动以相对于所述壳体朝近侧移动,使得所述假体瓣膜布置在所述长形鞘的管腔的外部。
附图说明
图1是具有植入其中的假体二尖瓣的心脏的一部分的横截面图。
图2是根据一个实施例的递送装置的示意图。
图3是根据一个实施例的瓣膜装载装置的示意图。
图4是根据一个实施例的递送装置的俯视图。
图5是图4的递送装置的分解图。
图6是图4的递送装置的手柄组件的侧视图。
图7是图6的手柄组件的侧视横截面图。
图8是图4的递送装置的导管组件的侧视图。
图9是图8的导管组件的侧视横截面图。
图10A是图4的递送装置的瓣膜保持管的透视图。
图10B是图10A的瓣膜保持管的侧视横截面图。
图11是图4的递送装置的手柄组件的俯视图,示出了朝远侧致动的递送杆。
图12A是图4的递送装置的俯视图,示出了递送鞘处于第一部分致动位置。
图12B是图4的递送装置的俯视图,示出了递送鞘处于第二完全致动位置。
图13是根据另一实施例的递送装置的透视图。
图14是根据一个实施例的再捕获装置的侧视图,并且示出为联接到假体瓣膜的框架。
图15是图14的再捕获装置和假体瓣膜框架的一部分的放大图,示出了内扩张器构件处于与假体瓣膜框架接合的第一位置。
图16是图14的再捕获装置和假体瓣膜框架的一部分的放大图,示出了内扩张器(不可见)处于布置在外扩张器内的第二位置,并且外鞘在外扩张器的一部分上延伸,并且瓣膜的一部分被捕获在外鞘内。
图17是图14的再捕获装置和假体瓣膜框架的一部分的放大图,示出了外扩张器(不可见)布置在外鞘内并且瓣膜框架的一部分被捕获在外鞘内。
图18是根据一个实施例的瓣膜装载装置的透视图。
图19是图18的瓣膜装载装置的分解图。
图20A是图18的瓣膜装载装置的俯视图。
图20B是图20A的瓣膜装载装置的横截面图。
图21A是图18的瓣膜装载装置的手柄组件的侧视图。
图21B是图21A的手柄组件的横截面图。
图22A是图18的瓣膜装载装置的顶帽组件的侧视图。
图22B是图18的瓣膜装载装置的外漏斗的侧视图。
图23是在装载装置的致动之前、图示为处于第一位置的图18的瓣膜装载装置的横截面图。
图24是在用从手柄组件延伸的导螺杆致动装载装置之后、图示为处于第二位置的图18的瓣膜装载装置的横截面图。
图25是根据另一实施例的瓣膜装载装置的透视图,示出了装载导螺杆处于致动位置。
图26是示出根据一个实施例递送假体心脏瓣膜的方法的流程图。
图27是根据一个实施例的套件的示意图。
图28是根据一个实施例的扩张器装置的侧视图。
图29是沿着图28的线B-B截取的横截面图。
图30是处于膨胀配置的图28的扩张器装置的球囊构件的侧视图。
图31是处于塌缩配置的图28的扩张器装置的球囊构件的侧视图。
图32是图30中的细部C的放大图。
图33是图30的球囊构件的远端视图。
图34是沿着图30中的线D-D截取的横截面图。
图35是沿着图30中的线E-E截取的横截面图。
图36是图28的扩张器装置的球囊构件、长形充胀管和长形导丝管的侧视图。
图37是图36中的细部F的放大图。
图38是沿着图37中的线G-G截取的横截面图。
图39是图28的球囊构件和长形充胀管的侧视图。
图40是图39中的细部H的放大图。
图41是图28的长形充胀管的远侧部分的侧视图。
图42是沿着图41中的线I-I截取的图41的长形充胀管的横截面图。
图43是示出为部分地布置在递送鞘内的根据另一实施例的扩张器装置的球囊构件的侧视图。
图44是根据另一实施例的再捕获装置的透视图。
图45是图44的再捕获装置的侧视图。
图46是图44和45的再捕获装置的侧视横截面图。
图47是根据另一实施例的再捕获装置的透视图。
图48是图47的再捕获装置的侧视图。
图49是图47和48的再捕获装置的侧视横截面图。
图50是根据另一实施例的再捕获装置的透视图。
图51是图50的再捕获装置的侧视图。
图52是图50的再捕获装置的侧视横截面图。
图53是根据另一实施例的再捕获装置的透视图。
图54是图53的再捕获装置的侧视横截面图。
图55是图53的再捕获装置的俯视图。
图56是沿着图55中的线56-56截取的横截面图。
具体实施方式
本文描述了用于将假体心脏瓣膜(例如,假体二尖瓣)递送和部署到心脏中的装置和方法。在一些实施例中,如本文所述的递送装置可以用于部署和重新定位假体心脏瓣膜。在一些实施例中,如本文所述的递送装置可以包括用于允许精确的瓣膜部署的两阶段受控部署机构。如本文所述的递送装置可以包括能够适应各种瓣膜尺寸的单个34Fr多合一(all-in-one)系统。在一些实施例中,本文描述了能够用于重新定位和/或收回所部署的假体心脏瓣膜的重新定位和收回装置。重新定位和收回装置可以包括植入心脏内的假体瓣膜的两阶段受控捕获以重新定位和/或移除/收回假体瓣膜。
尽管本文参考假体二尖瓣描述了一些实施例,但是应当理解,本文所述的装置和方法可以用于部署、重新定位和/或移除其他任何类型的心脏瓣膜。例如,本文所述的装置和方法可以用于部署、重新定位和/或移除三尖瓣心脏瓣膜、肺动脉心脏瓣膜或主动脉心脏瓣膜。此外,本文所述的装置和方法可以从各种递送进路用于心脏,例如,经心尖进路、经心房或经心室或经血管进路(例如经颈动脉,经股动脉)。
在一些实施例中,扩张器装置可以联接到或包含在递送装置内。在一些实施例中,扩张器装置可以包括球囊扩张器构件,并且通过例如在递送装置的手柄组件或导管组件中限定的端口插入。下面参考图13和28-43描述这样的扩张器装置。扩张器装置的使用可以帮助降低损伤假体瓣膜和/或心脏(例如,心房)的风险。
如本文所述,在一些实施例中,一种递送装置可以包括具有一个或多个致动器的手柄组件、递送导管组件和瓣膜保持管。瓣膜保持管能够可移除地联接到手柄组件的远端部分并且可移除地联接到递送导管组件的接头。在一些实施例中,瓣膜保持管可以联接到手柄组件,并且瓣膜保持管和手柄组件能够共同地和可移动地联接到递送导管。在一些实施例中,瓣膜保持管可以在联接到手柄组件之前联接到导管组件。在一些实施例中,在使用期间,在导管组件插入心脏中之前将瓣膜保持管联接到手柄组件和导管组件。在一些实施例中,在导管组件已插入心脏中之后,瓣膜保持管和手柄组件能够共同地和可移动地联接到递送导管组件。本文也描述了扩张器装置,其能够可选地在将假体瓣膜(例如,假体二尖瓣)递送到心脏的程序期间被使用并且可以通过递送导管的管腔被接收。本文所述的递送装置可以用于以受控方式将假体二尖瓣部署到心脏中,从而提供假体二尖瓣在递送导管内以及进入心脏中的增量移动。
在一些实施例中,一种装置包括导管组件、瓣膜保持管和手柄组件。瓣膜保持管能够可释放地联接到导管组件的近端部分和手柄组件的远端部分。手柄组件包括壳体和递送杆。递送杆配置成被致动以相对于壳体朝远侧移动,从而将布置在瓣膜保持管内的假体心脏瓣膜移出瓣膜保持管,并且在导管组件的长形鞘的管腔内朝远侧移动。导管组件配置成被致动以相对于壳体朝近侧移动,使得假体瓣膜布置在长形鞘的管腔的外部。
在一些实施例中,一种装置包括:装载漏斗组件,所述装载漏斗组件配置成当瓣膜处于非塌缩或偏压膨胀配置时在其中接收假体心脏瓣膜,以及限定内部区域的瓣膜保持管,所述内部区域配置成接收处于塌缩配置的假体心脏瓣膜。瓣膜保持管具有配置成可释放地联接到装载漏斗组件的第一端部分和第二端部分。装置还包括手柄组件,所述手柄组件包括手柄和装载导螺杆。装载导螺杆能够可释放地联接到瓣膜保持管的第二端部分。手柄组件还包括系绳保持机构和致动器旋钮。系绳保持机构可以将从布置在漏斗组件内的假体心脏瓣膜延伸的系绳固定在相对于手柄组件的固定位置。致动器旋钮可操作地联接到装载导螺杆和手柄,使得手柄和装载导螺杆之间的相对移动导致假体瓣膜布置在瓣膜保持管内。
在一些实施例中,一种装置包括再捕获装置,所述再捕获装置可以用于移除或重新定位部署在心脏内的假体心脏瓣膜。再捕获装置包括外鞘、外扩张器、内扩张器和手柄组件。外鞘限定第一管腔,并且外扩张器限定第二管腔并且可移动地、至少部分地布置在外鞘的第一管腔内。内扩张器可移动地、至少部分地布置在外扩张器的第二管腔内并且包括远侧末端。手柄组件包括可操作地联接到内扩张器并且可操作地联接到外扩张器的致动器以及将从假体心脏瓣膜延伸的系绳固定到手柄组件的系绳保持机构。致动器包括可操作地联接到第一弹簧(其联接到内扩张器)和第二弹簧(其联接到外扩张器)的驱动机构。当致动器被致动时,在从假体心脏瓣膜延伸的系绳固定到系绳保持机构的情况下,内扩张器相对于外扩张器朝近侧移动,使得假体心脏瓣膜的第一部分被牵拉到外扩张器的第二管腔内并且移动到塌缩配置。可以在内扩张器之后顺序地致动外扩张器以相对于外鞘朝近侧移动外扩张器,使得在假体心脏瓣膜的第一部分的远侧的假体心脏瓣膜的第二部分在外鞘的第一管腔内被牵拉并且移动到塌缩配置。
在一些实施例中,一种将经导管二尖瓣置换件递送到心脏的二尖瓣环的方法包括使用如本文所述的递送装置将经导管二尖瓣假体部署到二尖瓣环中。经导管二尖瓣假体可以由具有布置在其中的瓣膜小叶的可膨胀金属支架主体制成。支架主体可以用合成材料或稳定的心包组织覆盖,并且瓣膜小叶可以由稳定的心包组织制成。可膨胀金属支架主体可以具有可选的心房套囊,并且套囊能够可选地具有由合成材料和/或稳定的心包组织制成的覆盖物。经导管二尖瓣假体可以经由导管在压缩状态下被部署,并且在从导管排出后膨胀。二尖瓣假体(在本文中也被称为“假体二尖瓣”或“假体瓣膜”或“假体心脏瓣膜”)可以包括联接到二尖瓣假体的近端部分的一个或多个系绳。
一个或多个系绳的远端可以例如锚固在左心室中。在紧固一个或多个系绳以建立固定长度并将系绳固定到例如心脏的心尖区域之前,一个或多个系绳可以被上紧和/或以其他方式被调节到期望的张力。能用本文公开的装置和方法递送的假体二尖瓣可以包括例如在下列国际专利申请中公开的那些:于2014年5月30日提交的、发明名称为“用于假体二尖瓣的结构构件(Structural Members for Prosthetic Mitral Valves)”的申请号为PCT/US14/40188的国际专利申请(“PCT申请'40188”),于2014年6月25日提交的、发明名称为“用于假体心脏瓣膜的血栓管理和结构顺应特征(Thrombus Management andStructural Compliance Features For Prosthetic Heart Valves)”的申请号为PCT/US14/44047的国际专利申请(“PCT申请'44047”),于2014年10月2日提交的、发明名称为“假体心脏瓣膜及其递送系统和递送方法(Prosthetic Heart Valve and Systems andMethods for Delivering the Same)”的申请号为PCT/US14/58826的国际专利申请(“PCT申请'58826”),以及于2016年1月6日提交的、发明名称为“假体二尖瓣及其递送装置和递送方法(Prosthetic Mitral Valves and Apparatus and Methods for Delivery ofSame)”的申请号为PCT/US16/12305的国际专利申请(“PCT申请'12305”),上述申请的公开内容通过引用并入本文。
在一些实施例中,一种外科套件包可以包括如本文所述的递送装置以及如本文所述能够在递送经导管假体瓣膜的程序中与递送装置一起使用的辅助部件。递送装置和辅助部件可以布置在无菌包装内。例如,在一些实施例中,套件可以包括如本文所述的递送装置和扩张器装置和/或瓣膜装载装置。在一些实施例中,套件也可以包括经导管瓣膜(例如,假体二尖瓣)和/或可以用于将经导管瓣膜固定在心脏内的适当位置的心外膜垫。在一些实施例中,套件可以包括如本文所述的收回和重新定位装置。
当在本文中使用时,词语“近侧”和“远侧”分别是指更接近和远离例如医疗装置的操作者的方向。因此,例如,最接近患者的身体(例如,接触患者的身体或布置在患者的身体内)的医疗装置的端部将是医疗装置的远端,而与远端相对并且最接近例如医疗装置的使用者(或使用者的手)的端部将是医疗装置的近端。
图1是心脏的左心室LV和左心房LA的横截面图,心脏具有部署在其中的经导管假体二尖瓣PMV以及将假体二尖瓣PMV固定到心脏的心尖区域的心外膜锚固装置EAD。图1示出了座置到原生瓣膜环NA中并且利用假体二尖瓣PMV的心房套囊AC、来自原生小叶的径向张力、以及由附接部分Tp固定到假体二尖瓣PMV和心外膜锚固件EAD的心室系绳T保持在原生瓣膜环中的假体二尖瓣PMV。本文所述的装置和方法可以与心外膜锚固装置的各种不同类型和实施例结合使用,例如在发明名称为“心外膜锚固装置和方法(Epicardial AnchorDevices and Methods)”的申请号为PCT/US14/49218的待决国际专利申请(“PCT申请'49218”)中描述的那些,上述申请的公开内容通过引用整体并入本文。
图2是根据一个实施例的递送装置的示意图。递送装置100可以用于在心脏内递送和部署假体心脏瓣膜,例如假体二尖瓣。递送装置100包括导管组件130、能够可移除地联接到导管组件130的手柄组件120、以及能够可移除地联接到手柄组件120和导管组件130的瓣膜保持管125。
导管组件130包括接头132和递送鞘136。递送鞘136限定管腔(在图2中未示出),瓣膜保持管125可以通过所述管腔插入以递送布置在瓣膜保持管125内的假体瓣膜(在图2中未示出),正如下文更详细地描述的那样。在一些实施例中,递送鞘136可以是例如34Fr编织鞘。接头132布置在鞘136的近端处且限定内部区域,假体瓣膜在插入鞘136的管腔中之前首先通过所述内部区域被引入。在使用中,当鞘插入心脏中时接头132保持在心脏的外部并且可以提供到鞘的管腔的通路。接头132也可以包括端口(在图2中未示出),通过所述端口可以引入诸如扩张器装置这样的装置,正如下文更详细地描述的那样。
手柄组件120包括壳体122、联接到壳体122的系绳保持和机械保持联接器(在本文中也称为“保持机构”)127、从壳体122朝远侧延伸的递送杆124、联接到壳体122的近侧致动器旋钮126(也称为“近侧致动器”或“第一致动器”)、以及联接到壳体的远侧致动器旋钮128(也称为“远侧致动器”或“第二致动器”)。近侧致动器旋钮126能够可操作地联接到递送杆124并且用于在递送鞘136内朝远侧移动或推送预先装载到瓣膜保持管125中并且联接到手柄组件120的假体心脏瓣膜,正如下文更详细地描述的那样。远侧致动器旋钮128能够可操作地联接到递送鞘136并且用于在将假体瓣膜部署到心脏中期间致动或移动递送鞘136。例如,假体瓣膜可以首先由递送杆124朝远侧移动,直到其定位在递送鞘136的远端部分内,并且随后将假体瓣膜部署在心脏内,递送鞘136朝近侧移动,将假体瓣膜布置在递送鞘136的外部和心脏内。远侧致动器128可以提供假体瓣膜的缓慢、受控的部署。在一些实施例中,递送鞘136也可以被致动以再捕获已经部署在心脏内的假体心脏瓣膜,使得假体瓣膜可以被重新定位或移除。例如,在将瓣膜初始部署于心脏内的情况下,可能期望重新定位瓣膜。递送装置100可以被致动以部分地再捕获瓣膜的近侧部分以对其位置进行调节。例如,递送鞘可以被致动以朝远侧移动以再捕获瓣膜的一部分,然后在瓣膜已被重新定位之后,鞘可以被致动以再次朝近侧移动以释放瓣膜。递送杆124也可以用于再捕获假体瓣膜的一部分。例如,递送杆124可以限定管腔并且可以被致动以朝远侧移动,使得假体瓣膜的一部分被再捕获在递送杆124的管腔内。下面参考具体实施例提供使用递送装置来递送和部署假体心脏瓣膜的更多细节。
瓣膜保持管125可以将处于压缩配置的假体二尖瓣(在图2中未示出)包含或保持在瓣膜保持管125的内部管腔内。正如参照图3所述,在一些实施例中,瓣膜装载装置160可以用于将假体瓣膜装载到瓣膜保持管125中,使得假体瓣膜以受控方式被压缩到期望的压缩尺寸和形状。下面也参考具体实施例(参见例如图18-24)更详细地描述这样的瓣膜装载装置。瓣膜保持管125(其中具有假体二尖瓣)可以联接到手柄组件120的远端部分。例如,瓣膜保持管125可以联接到手柄组件120,使得手柄组件120的递送杆124的远端部分的一部分可以被接收在瓣膜保持管125的内部区域内。在一些实施例中,瓣膜保持管125和手柄组件120可以包括配合的快速连接联接器以将瓣膜保持管125可释放地联接到手柄组件120。在将瓣膜保持管125联接到递送装置220之前,联接到(处于瓣膜保持管125内的)假体瓣膜的系绳(未示出)可以穿过由递送杆124限定的管腔并且朝近侧延伸到手柄组件120之外。
瓣膜保持管125可以具有各种长度以适应将假体心脏瓣膜递送到心脏的各种不同的程序。例如,在一些实施例中,瓣膜保持管125可以具有在约2cm至15cm之间的长度。在一些实施例中,鞘136可以具有约12cm至约38cm的长度。在一些实施例中,鞘136可以具有约50cm至约150cm的长度。
在一些实施例中,假体心脏瓣膜(例如,二尖瓣)可以使用本文所述的递送装置100经心尖地递送,即通过心脏的左心室的心尖递送。利用这样的经心尖递送,递送装置100可以通过肋间递送进入心脏和心包腔(pericardial space)。在该情况下,鞘136可以具有例如12-38cm的长度。
在另一种递送进路中,递送装置100可以使用顺行或逆行递送进路递送假体心脏瓣膜,而不需要使用在这样的程序中常用的刚性管系统。在另一实施例中,递送装置100可以经由经中隔进路进入心脏。在任一情况下,在必须行进长距离时,瓣膜保持管125可以具有例如60-150cm的长度。
系绳保持机构127可以联接到壳体122的近端部分,并且可以用于将从假体瓣膜延伸的系绳联接到手柄组件120。联接到假体瓣膜的一个或多个系绳可以延伸通过手柄组件120,并且也可以插入或穿过保持机构127。在一些实施例中,保持机构127包括弹簧机构,所述弹簧机构可以用于将系绳固定到系绳保持机构127并且因此固定到手柄组件122。弹簧机构可以在部署期间被致动以偏转系绳(例如,弯曲系绳的镍钛诺丝)并且在系绳上施加恒定或基本恒定的力(例如,张力)。弹簧机构也可以允许在部署假体瓣膜之后在移除递送装置期间调节施加到假体瓣膜的力。系绳上的张力可以被释放以允许假体瓣膜的移动,并且随后再张紧以将系绳和假体瓣膜固定在新的位置。在一些实施例中,系绳保持机构127包括系绳钉扎机构。在这样的实施例中,钉扎构件可以用于穿刺系绳以将系绳固定到保持机构127。
因为对于大压力下的压缩瓣膜而言,从导管释放可以将假体瓣膜发射例如数英尺的距离,所以系绳保持机构127能够在部署程序期间提供额外的安全性。然而,通过利用本文提供的保持机构127以及用以提供缓慢的校准部署的能力,使用者可以控制部署以防止瓣膜从鞘136意外地发射。
在将假体二尖瓣在心脏内递送和部署的一个示例性应用中,导管组件130的鞘136可以通过患者的心脏的心外膜表面插入,并且通过左心室延伸到心脏的左心房,使得接头132靠近或接触心外膜表面而布置在心脏的外侧上。在一些实施例中,在将鞘136引入心脏中之前,导丝(未示出)延伸到心脏中并延伸到左心房。鞘136随后可以在导丝上穿入以插入心脏中。例如,导丝可以延伸通过鞘136并且从布置在接头132上的端口伸出。在一些实施例中,在将鞘136插入心脏中之前,扩张器装置(在图2中未示出)可以被插入通过接头132的端口并且通过鞘136的管腔,使得扩张器装置的锥形远端部分延伸到鞘136的远端的外部。扩张器装置的锥形远端可以提供用于鞘136的导入并且帮助打开或扩大在心外膜表面处且通过二尖瓣环的进入开口。在于2014年10月29日提交的美国专利申请第14/527,382号(“'382申请”)中描述了示例性扩张器装置,其全部公开内容通过引用并入本文。在本文中参考图13和28-43描述了扩张器装置的其他实施例。当鞘136安置在心脏内的期望位置时,可以移除扩张器装置,使鞘136留在心脏内。下面描述了扩张器装置的更多细节。
如上所述,瓣膜保持管125(其中布置有假体瓣膜)可以联接到手柄组件120的远端部分。从瓣膜延伸的系绳可以穿过递送杆124并延伸到手柄组件120的近端之外。在瓣膜保持管125联接到手柄组件120的远端部分且递送杆124的远端部分布置在瓣膜保持管125内的情况下,瓣膜保持管125可以插入导管组件130的接头132中并联接到接头132。在一些实施例中,瓣膜保持管125上的O形环(在图1中未示出)可以保持瓣膜保持管125在接头132内的位置。例如,在一些实施例中,瓣膜保持管125和接头132可以包括配合的快速连接联接器(其包括O形环)以将瓣膜保持管125可释放地联接到接头132。
在瓣膜保持管125联接到导管组件的情况下,近侧致动器旋钮126能够随后被致动(例如,旋转)以朝远侧移动递送杆124,使得递送杆124的远端推送假体瓣膜离开瓣膜保持管125并进入递送鞘136的远端部分。当递送杆124朝远侧移动时,递送杆124相对于手柄组件120的壳体122移动,并且瓣膜保持管125相对于壳体122保持固定,允许递送杆124推送假体瓣膜离开瓣膜保持管125并进入递送鞘136。系绳能够随后固定到保持机构127,将瓣膜固定到壳体122。远侧致动器旋钮128能够随后被致动以使递送鞘136(以及经由接头132与其联接的瓣膜保持管125)相对于壳体122朝近侧缩回或移动,使得假体瓣膜留置在递送鞘136的外部并且留置在心脏的左心房内或原生二尖瓣的瓣环内。在假体瓣膜已部署之后,可以根据需要操纵和重新定位假体瓣膜,并且随后系绳可以从保持机构127释放。系绳能够随后例如用心外膜垫(例如,图1中的EAD)固定到心脏的心外膜表面,如上所述。
在替代的示例性程序中,不同于首先将导管组件130插入心脏中,并且随后将瓣膜保持管125和手柄组件120与其联接,可以在导管组件130插入心脏中之前就将瓣膜保持管125联接到手柄组件120和导管组件130这两者。在这样的程序中,可以采用上述的相同步骤以用于将导管组件130插入心脏中,例如,在导丝上和/或使用如上所述的扩张器装置插入导管组件130。能够随后以如上所述的相同方式致动递送装置100以首先在递送鞘136内朝远侧移动假体瓣膜,并且随后朝近侧移动递送鞘136以将假体瓣膜布置在心脏中。
图3是瓣膜装载装置160的示意图。瓣膜装载装置160包括漏斗组件115、装载手柄组件165和上述的瓣膜保持管125。在将瓣膜保持管125联接到手柄组件120和导管组件130之前,使用瓣膜装载装置160将假体瓣膜(在本文中也称为“瓣膜”)装载到瓣膜保持管125中。瓣膜首先安置在漏斗组件115内以将瓣膜从偏压膨胀配置移动到塌缩配置。漏斗组件115包括外漏斗164和内漏斗或定心锥162。瓣膜安置在外漏斗164内,并且随后内漏斗联接到外漏斗164,将瓣膜夹在其间并且以受控方式将瓣膜压缩到期望的形状和配置。瓣膜保持管125能够以与上述的如何将瓣膜保持管125联接到手柄组件120和导管组件130相类似的方式经由快速连接联接器可释放地联接到漏斗组件115和装载手柄组件165。
装载手柄组件165包括手柄157(也称为“主装载旋钮”或“致动器”)、用于固定联接到瓣膜的系绳的保持机构168、以及可操作地联接到手柄157的装载导螺杆166。在瓣膜保持管125联接到漏斗组件115和装载手柄组件165的情况下,并且在从瓣膜延伸的系绳固定到保持机构168的情况下,瓣膜装载装置160可以被致动以将瓣膜从其布置在漏斗组件内的第一位置移动到瓣膜布置在瓣膜保持管125内的第二位置。更具体地,手柄167可以被旋转,这相应地使导螺杆相对于手柄167转动,这相应地使瓣膜保持管125和漏斗组件115移动远离手柄167。由于在致动期间(通过系绳固定到保持机构168)瓣膜处于相对于手柄167的固定位置(即,静止),漏斗组件115移动远离手柄,并且瓣膜保持管125在瓣膜上移动,因此将瓣膜布置在瓣膜保持管125的内部区域内。下面参照图18-25和瓣膜装载装置560描述瓣膜装载装置160的各种部件和操作的细节。
图4-12示出了根据一个实施例的递送装置。递送装置200包括导管组件230、能够可移除地联接到导管组件230的手柄组件220、以及能够可移除地联接到手柄组件220和导管组件230的瓣膜保持管225。递送装置200可以包括与上述递送装置100相同或类似的部件和特征,并且可以在功能上相同或相似。递送装置200可以用于在心脏内递送和部署假体心脏瓣膜,例如假体二尖瓣(未示出),正正如上面关于先前实施例所述的那样。
导管组件230包括接头232和递送鞘236。递送鞘236限定管腔221(图9),预先布置在瓣膜保持管225的内部区域内的假体瓣膜(未示出)可以在递送假体瓣膜期间移动到所述管腔中。接头232布置在鞘236的近端处并且限定内部区域,假体瓣膜在插入鞘236的管腔中之前首先通过所述内部区域被引入。在使用中,当鞘插入心脏中时,接头232保持在心脏的外部并且可以提供到鞘236的管腔的通路。接头232还包括端口237,在假体心脏瓣膜的递送期间可以通过所述端口插入和使用各种装置,例如扩张器装置(未示出),正如关于图13的实施例更详细地描述的那样。下面参照图28-43描述了可以与递送装置200一起使用的扩张器装置的其他实施例。端口237也可以用于接收导丝从中通过。例如,导丝可以穿过递送鞘236的远端、进入接头232的内部、并且通过端口237离开。
手柄组件220包括壳体222、联接到壳体222的系绳保持机构227、联接到壳体222的递送杆224、近侧致动器旋钮226(也称为“第一致动器”或“近侧致动器”)、以及联接到壳体222的远侧致动器旋钮228(也称为“第二致动器”或“远侧致动器”)。部署行程窗口223布置在壳体222上并且可以用于查看假体瓣膜的递送进度。例如,递送杆224可以包括通过部署行程窗口可见的标记。标记可以例如用数字或字母标注,或者可以进行颜色编码。标记可以指示在瓣膜部署期间瓣膜已朝远侧行进的进度或距离。也可以包括指示在瓣膜的部署期间递送鞘的近侧移动的标记。
近侧致动器旋钮226可以用于在递送鞘236内朝远侧移动或推送预先装载到瓣膜保持管225中并且联接到手柄组件220的假体心脏瓣膜(未示出)。例如,近侧致动器旋钮226能够可操作地联接到递送杆224,并且可以用于在递送鞘236内相对于壳体222朝远侧移动递送杆224,使得递送杆224接合假体心脏瓣膜并且在递送鞘236内朝远侧移动(例如推送)假体心脏瓣膜,直到假体心脏瓣膜布置在递送鞘236的远端部分内。在该实施例中,近侧致动器226旋转,这相应地促使杆224相对于壳体222移动。当部署瓣膜时,瓣膜保持管225以固定的关系固定到壳体222,并且因此当杆224被致动时不相对于壳体222移动。这允许杆224将瓣膜朝远侧推出瓣膜保持管225并进入接头232,并且随后在递送鞘236的远端部分内推送。在瓣膜布置在递送鞘236的远端内的情况下,系绳可以经由保持机构227固定到壳体222。
远侧致动器旋钮228能够可操作地联接到递送鞘236并且用于在假体瓣膜部署到心脏中期间致动或移动递送鞘236。在该实施例中,如图7所示,远侧致动器旋钮228联接到导螺杆229,所述导螺杆相应地连接到瓣膜保持管225。因此,当瓣膜保持管225联接到接头232时,导螺杆229可以被致动以使瓣膜保持管225和导管组件230相对于壳体移动。例如,如上所述,在假体瓣膜布置在递送鞘236内的情况下,为了将假体瓣膜部署到心脏中,(通过致动远侧致动器旋钮228而使)递送鞘236相对于壳体222朝近侧移动,将假体瓣膜布置在递送鞘236的外部和心脏内。
递送鞘236也可以被致动以部分地再捕获已经部署在心脏内的假体心脏瓣膜,使得假体瓣膜可以被重新定位。例如,在假体瓣膜已如上所述地被部署之后,如果确定假体瓣膜应当被重新定位,则致动器旋钮228可以在相反方向上被致动以朝远侧移动导螺杆229,促使递送鞘236在假体瓣膜的近侧部分上朝远侧往回移动。然后递送装置200可以被操纵以将假体瓣膜定位在期望位置,并且随后致动器旋钮228可以被致动以朝近侧移动递送鞘236,再次从递送鞘236释放假体瓣膜。此外,如先前所述,递送杆224可以由致动器旋钮226致动以朝远侧移动以将假体瓣膜的一部分再捕获在递送杆224的管腔内。
正如上面关于先前实施例所述,瓣膜保持管225(参见例如图10A和图10B)可以将处于压缩配置的假体二尖瓣(未示出)包含或保持在瓣膜保持管225的内部管腔内。如上面关于图3所述,并且如下面关于图18-25所述,可以使用瓣膜装载装置将假体瓣膜预装载到瓣膜保持管225中,使得假体瓣膜以受控方式被压缩到期望的压缩尺寸和形状。瓣膜保持管225(具有在其中的假体二尖瓣)能够可移除地联接到手柄组件220的远端部分并且可移除地联接到导管组件230的接头232。
例如,如譬如图5所示,瓣膜保持管225可以包括第一快速连接联接器211(在该实施例中为阴连接器)和第二快速连接联接器212(在该实施例中为阳连接器)。第一快速连接器211可以配合地联接到布置在手柄组件220的远端部分处的快速连接联接器213(在该实施例中为阳性连接器)。类似地,瓣膜保持管225的第二快速连接联接器212可以配合地联接到布置在导管组件230的接头232上的快速连接联接器214(在该实施例中为阴连接器)。快速连接联接器可以包括O形环以保持瓣膜保持管225相对于手柄组件220和导管组件230的位置。快速连接联接器可以是各种不同类型的合适的联接器/连接器。例如,快速连接联接器可以是卡口连接器或1/4圈连接器。应当理解,在替代实施例中,阳联接器和阴联接器可以颠倒(例如,瓣膜保持管225的联接器211可以是能够配合地联接到手柄组件的阴联接器213的阳联接器)。在瓣膜保持管225联接到手柄组件的情况下,手柄组件220的递送杆224的远端部分可以被接收在瓣膜保持管225的内部区域内。在将瓣膜保持管225联接到递送杆224之前,联接到(在瓣膜保持管225内的)假体瓣膜的系绳(未示出)可以穿过由递送杆224限定的管腔并且朝近侧延伸到手柄组件220之外。
瓣膜保持管225可以配置成与上述的瓣膜保持管125相同或相似,并且可以在功能上相同或相似。例如,瓣膜保持管225可以具有各种长度以适应将假体心脏瓣膜递送到心脏的各种不同的程序。保持机构227可以联接到壳体222的近端部分。在该实施例中,保持机构227包括系绳钉扎构件,所述系绳钉扎构件可以配置成穿刺系绳并且将系绳固定到保持机构227。
在使用中为了在心脏内递送和部署假体二尖瓣,瓣膜保持管225可以经由上述的快速连接联接器联接到手柄组件220和导管组件230。例如,瓣膜保持管225可以插入导管组件230的接头232中,并且快速连接联接器212和214可以保持瓣膜保持管225在接头232内的位置。类似地,快速连接联接器211和213可以保持瓣膜保持管225相对于手柄组件220的位置。导管组件230的递送鞘236可以通过患者的心脏的心外膜表面插入并且通过心脏的左心室延伸到左心房,使得接头232靠近或接触心外膜表面而布置在心脏的外侧上。如上所述,在一些实施例中,在将鞘236引入心脏中之前,导丝延伸到心脏中并且延伸到左心房。鞘236能够随后在导丝上穿入以插入心脏中。在一些实施例中,在将鞘236插入心脏中之前,可以如上所述使用扩张器装置(未示出)(参见例如图13中的扩张器装置354,以及下面描述的扩张器装置834和934)以提供用于将递送装置200插入患者的心脏中的锥形远侧插入末端。如上面关于递送装置100所述,在替代的程序中,在将瓣膜保持管225与导管组件联接之前,可以首先将导管组件230插入心脏中。
图4示出处于准备使用位置的已组装的递送装置200(例如,瓣膜保持管225联接到壳体222和导管组件230,其中装载有假体瓣膜)。近侧致动器旋钮226能够随后被致动(例如,旋转)以朝远侧(在图4和11中的箭头A的方向上)移动递送杆224,并且将假体瓣膜推出瓣膜保持管225并推入递送鞘236的远端部分,如上所述。图11为了示例性目的示出了无导管组件230和瓣膜保持管225的递送手柄220以示出朝远侧致动以将假体瓣膜推出瓣膜保持管225的递送杆224。当递送杆224朝远侧移动时,瓣膜保持管225相对于壳体222保持静止或固定,允许递送杆224将假体瓣膜从瓣膜保持管225推出并推入递送鞘236,直到瓣膜保持管225布置在递送鞘236的远端部分处。系绳可以固定到保持机构227,并且远侧致动器旋钮228能够随后被致动以使递送鞘236相对于壳体222朝近侧缩回或移动,使得假体瓣膜留置在递送鞘236的外部和心脏的左心房内。更具体地,如上所述,远侧致动器228可操作地联接到导螺杆229,所述导螺杆联接到瓣膜保持管225。因此,由于瓣膜保持管225也联接到递送鞘236,递送鞘236也相对于壳体222朝近侧(图12A和12B中的箭头B的方向)移动。图12A示出了部分缩回(朝近侧移动)的递送鞘236,并且与其联接的瓣膜保持管225被示出为部分地布置在壳体222内。图12B示出了完全缩回的递送鞘236、部分地布置在壳体222内的接头232、以及完全布置在壳体222内的瓣膜保持管225。在假体瓣膜已部署之后,在系绳联接到保持机构227的情况下,假体瓣膜可以根据需要被操纵和重新定位,并且随后系绳可以从保持机构227释放。系绳能够随后例如用心外膜垫(例如,图1中的EAD)固定到心脏的心外膜表面,如上所述。
此外,在固定系绳之前,如上所述,如果在假体瓣膜的初始部署时确定瓣膜应当被重新定位,则递送装置200可以被致动以部分地再捕获瓣膜的近侧部分以对其位置进行调节。例如,递送鞘236可以被致动以朝远侧移动以再捕获瓣膜的一部分,然后在已重新定位瓣膜之后,鞘236可以被致动以再次朝近侧移动以释放瓣膜。替代地,递送杆224也可以用于再捕获假体瓣膜的一部分。例如,递送杆224可以被致动以朝远侧移动,使得假体瓣膜的一部分被再捕获在递送杆224的管腔内。然后瓣膜可以被重新定位,并且随后递送杆224可以被致动以朝近侧移动以释放瓣膜。
图13示出了根据另一实施例的递送装置。递送装置300包括导管组件330、能够可移除地联接到导管组件330的手柄组件320、以及能够可移除地联接到手柄组件320和导管组件330的瓣膜保持管(未示出)。在该实施例中,瓣膜保持件管布置在手柄组件320的壳体322的内部和导管组件330内。递送装置300可以包括与上述的递送装置100和/或递送装置200相同或相似的部件和特征,并且可以在功能上相同或相似。递送装置300可以用于在心脏内递送和部署假体心脏瓣膜例如假体二尖瓣(未示出),正如上面关于先前实施例所述。
导管组件330包括接头332和递送鞘336。递送鞘336限定管腔(未示出),布置在瓣膜保持管内的假体瓣膜可以在假体瓣膜的递送期间移动到所述管腔中,正如上面关于先前实施例所述的那样。
手柄组件320包括壳体322、联接到壳体322的递送杆(未示出)、联接到壳体322的近侧致动器旋钮326、以及联接到壳体322的远侧致动器旋钮328。部署行程窗口323布置在壳体322上,并且可以用于查看通过部署行程窗口323可见的假体心脏瓣膜的递送进度。近侧致动器旋钮326可以用于朝远侧移动或推送经由瓣膜保持管(未示出)装载到手柄组件320中的假体心脏瓣膜(未示出)。远侧致动器旋钮328可以用于在将假体瓣膜部署到心脏中期间致动或移动递送鞘336。例如,假体瓣膜可以朝远侧移动,直到其定位在递送鞘336的管腔的远端部分内。为了部署假体瓣膜,递送鞘336朝近侧移动,将假体瓣膜布置在递送鞘336的外部和心脏内。递送鞘336也可以被致动以再捕获已部署在心脏内的假体心脏瓣膜,使得假体瓣膜可以如上关于递送装置100和200所述的那样进行重新定位。尽管在图7和8中并未示出,但是壳体322也可以包括联接到壳体322的弹簧系绳保持和机械保持联接器(在本文中也称为“保持机构”),正如上面关于先前实施例所述的那样。
如上所述,瓣膜保持管可以将处于压缩配置的假体二尖瓣包含或保持在瓣膜保持管的内部管腔内。瓣膜保持管(在其中具有假体二尖瓣膜)可以联接到手柄组件320的远端部分并且联接到导管组件330的接头332。正如上面关于先前实施例所述,当联接到手柄组件320时,递送杆的远端部分的一部分可以被接收在瓣膜保持管的内部区域内。在将瓣膜保持管联接到递送杆之前,联接到(在瓣膜保持管内的)假体瓣膜的系绳(未示出)可以穿过由递送杆限定的管腔并且朝近侧延伸到手柄组件320之外。
在该实施例中,示出了扩张器装置354,其可以在假体瓣膜的部署期间与递送装置300一起使用。扩张器装置354可以包括锥形的远端,其可以为鞘336提供引入,并且帮助打开或扩大在心外膜表面处且通过二尖瓣环的进入开口。扩张器装置354包括可膨胀的扩张器球囊构件334(在本文中也被称为“球囊构件”)。球囊构件334经由长形充胀管联接到球囊歧管356,所述长形充胀管延伸通过递送鞘336并且通过由接头332限定的端口337伸出。球囊构件334具有锥形的远侧末端部分以在将导管组件330插入心脏中期间提供导入。球囊歧管356可以联接到充胀介质并且用于使球囊构件334充胀和放泄。端口337在假体瓣膜的远侧布置在接头332上。换句话说,当瓣膜保持管(其包含假体瓣膜)联接到导管组件330时,假体瓣膜布置在球囊轴离开端口337的位置的近侧。图13还示出了运输心轴353,其可以通过扩张器装置354的管腔插入并且包括长形构件349。长形构件349可以插入通过球囊歧管356、通过由扩张器装置354限定的管腔,直到远端布置在球囊构件334的远端的外部。运输心轴353可以用于保持扩张器装置354的各种部件的对准,并且减少或消除在使用扩张器装置354之前的部件塌缩的可能性。在将递送装置300插入患者体内之前可以移除运输心轴353。
在使用中为了在心脏内递送和部署假体二尖瓣,在扩张器装置354、导管组件330、手柄组件320和瓣膜保持管(未示出)联接在一起的情况下,并且在球囊构件334充胀的情况下,递送鞘336可以通过患者的心脏的心外膜表面插入并且延伸通过左心室并伸入心脏的左心房,使得接头332靠近或接触心外膜表面而布置在心脏的外侧上。当递送鞘336定位在期望位置时,球囊构件334可以放泄并且通过端口337移除。
近侧致动器旋钮326能够随后被致动(例如,旋转)以朝远侧移动递送杆,并且以与上面关于先前实施例所述的类似方式将假体瓣膜推出瓣膜保持管并推入递送鞘336的远端部分。远侧致动器旋钮328能够随后被致动以使递送鞘336朝近侧缩回或移动,使得假体瓣膜留置在递送鞘336的外部并且留置在心脏的左心房内。
图14-17示出了根据一个实施例的再捕获装置。再捕获装置410可以用于捕获部署在心脏内的假体瓣膜,使得假体瓣膜可以被重新定位和/或收回/移除。再捕获装置410包括可操作地连接到手柄组件420的外鞘444、布置在外鞘444的管腔内的外扩张器442、以及可移动地布置在外扩张器442的管腔内并且可操作地联接到手柄组件420的内扩张器446。再捕获装置410还包括连接到手柄组件420的近端部分的系绳保持机构427。系绳保持机构427可以配置成与本文所述的和/或在上面通过引用并入本文的'382申请中描述的保持机构相同或相似,并且可以用于将系绳固定到再捕获装置410。内扩张器446限定可以接收假体瓣膜440的至少一部分的管腔,并且包括配置成接合植入心脏内的假体瓣膜的远侧末端,正如下文更详细地描述的那样。
手柄组件420包括壳体422、联接到壳体422并且可操作地联接到鞘444的近侧致动器旋钮426、以及联接到壳体422并且可操作地联接到扩张器构件446的远侧致动器旋钮428。部署行程窗口423布置在壳体422上,并且可以用于查看假体心脏瓣膜的移除或再捕获的进度。近侧致动器旋钮426(在本文中也称为“近侧致动器”或“第一致动器”)可以用于使内扩张器446在外扩张器442的管腔内朝远侧和朝近侧移动。远侧致动器旋钮428(在本文中也称为“远侧致动器”或“第二致动器”)可以用于朝远侧和朝近侧致动或移动外鞘444。
如图14和15所示,为了捕获已部署在心脏内的假体瓣膜440,联接到假体瓣膜440的系绳可以穿过或插入通过内扩张器446的管腔,并且通过致动近侧致动器426以使内扩张器446朝远侧移动到与瓣膜440接触,内扩张器446的远侧末端可以接合瓣膜440的近侧部分。因此,当内扩张器446朝远侧移动时,瓣膜440的一部分可以被接收在内扩张器446的管腔内并在其中塌缩,如图14和15所示。如图16所示,内扩张器446可以被致动(例如,转动或旋转近侧致动器旋钮426)以朝近侧移动内扩张器446,使得扩张器构件442的远侧末端和瓣膜440的第一部分被牵拉到外扩张器442的管腔内。例如,在瓣膜440的所述部分在内扩张器的管腔内塌缩的情况下,瓣膜440将与内扩张器446一起朝远侧移动。在瓣膜440被捕获的情况下,如图16所示,系绳可以固定到保持机构427,并且瓣膜440可以在心脏内移动/重新定位。
为了完全移除/收回瓣膜440,鞘444可以朝远侧移动,如图17所示,从而将瓣膜440进一步捕获在鞘444的管腔内,直到瓣膜440被完全捕获在外鞘444的管腔内。例如,远侧致动器旋钮428可以被致动(例如,旋转或转动)以使外鞘444相对于内扩张器446和外扩张器442朝外侧移动。外鞘444也相对于手柄组件422移动。因此,在系绳经由保持机构427固定到手柄组件422的情况下,外鞘444相对于瓣膜440朝远侧移动以将瓣膜440捕获在外鞘444的管腔内。在瓣膜440被捕获在鞘444的管腔内的情况下,通过从心脏和患者的身体移除再捕获装置410,瓣膜440可以从心脏被移除。
再捕获装置410的两阶段致动允许受控地捕获植入心脏内的假体瓣膜以重新定位和/或移除/收回假体瓣膜。瓣膜440的框架的近侧部分可以首先充分塌缩以使框架的一部分布置在外扩张器442的管腔内,并且随后当其移动到外鞘444的管腔中时可以转变成更完全的塌缩配置。下面参考图44-53描述再捕获装置的另外的实施例。
图18-25示出了根据一个实施例的瓣膜装载装置560。瓣膜装载装置560可以用于将假体瓣膜(未示出)装载到瓣膜保持管525中,所述瓣膜保持管525可以与本文所述的瓣膜保持管(例如125、225)相似或相同。在将瓣膜装载到瓣膜保持管中之前,瓣膜装载装置560可以用于将假体瓣膜压缩到期望的尺寸和形状。在上面通过引用并入本文的'382申请中描述了瓣膜装载装置的另一实施例。瓣膜装载装置560包括手柄组件565和漏斗组件515,所述漏斗组件包括顶帽组件596和外漏斗564。顶帽组件596包括内漏斗或定心锥562。如图20B和21B所示,手柄组件565包括可操作地联接到定心杆定位器563的定心杆561、装载导螺杆566和主装载旋钮或手柄567。系绳穿刺构件568可以用于将从假体瓣膜延伸的系绳固定在瓣膜装载装置560内。装载导螺杆566可以被致动以移动瓣膜保持管525并且捕获假体瓣膜,正如下文更详细地描述的那样。
瓣膜保持管525可以经由快速连接联接器550(在该实施例中为阴连接器)可移除地联接到手柄组件565,所述快速连接联接器550可以配合地联接到手柄组件565的装载引导螺钉566上的快速连接联接器551(在该实施例中为阳连接器)。瓣膜保持管525也可以经由快速连接联接器541(在该实施例中为阳连接器)联接到外漏斗564,所述快速连接联接器541可以配合地联接到外漏斗564上的快速连接联接器543(在该实施例中为阴连接器)。快速连接联接器550、551、541和543可以是例如卡口连接器或1/4圈连接器。快速连接联接器也可以包括O形环以保持瓣膜保持管525相对于手柄组件565和外漏斗564的位置。当瓣膜被装载在外漏斗564内时定心杆561可以用于使假体瓣膜居于中心并且将瓣膜保持在适当位置。定心杆固定旋钮569将定心杆561固定在适当位置。定心杆固定旋钮569可以是例如拇指螺钉或固定螺钉。
在一些实施例中,在将假体瓣膜装载到瓣膜装载装置560中之前,手柄组件565可以安置在固定件内,使得手柄组件565定位成竖直取向,其中快速连接联接器551处于顶部。如上所述,通过将瓣膜保持管525的快速连接联接器550联接到手柄组件565的快速连接联接器551,瓣膜保持管525可以联接到手柄组件565。通过将外漏斗564的快速连接联接器543联接到瓣膜保持管525的快速连接联接器541,外漏斗564可以联接到瓣膜保持管525。因此,手柄组件565、瓣膜保持管525和外漏斗564将在固定件内以竖直取向联接在一起。假体心脏瓣膜可以安置在由漏斗组件515的外漏斗564限定的内部区域内。瓣膜的系绳穿过外漏斗564、穿过瓣膜保持管525、并且穿过手柄组件565的定心杆561。系绳穿刺构件568可以被转动以穿刺系绳并且将系绳固定到装载装置560。在一些实施例中,对于不对称的假体二尖瓣而言,瓣膜被装载到装载装置560中,使得瓣膜的A2部段(参见PCT申请'58826)被向上装载。这可以确保瓣膜的A2部段以与其被递送到前原生小叶的A2区域相同的方式被压缩以减少或防止LVOT阻塞。内漏斗或定心锥562能够随后相应地用配合的螺纹部分597和598螺接到外漏斗564(参见例如图22A和22B),并且用快速连接器545(例如拇指螺钉或固定螺钉)固定到外漏斗564,所述快速连接器545将内漏斗/定心锥562锁定到外漏斗564,例如图20B所示。
注射器可以联接到顶帽组件596的端口548以提供盐水冲洗以去除装载装置560内的所有滞留气泡。瓣膜也可以针对空气进行检查、摇动、敲击以去除此时在装载装置560内的滞留空气等。如果看到任何气泡,则可以通过经由装载装置560(例如,用联接到端口548的注射器)冲洗盐水、尤其是冲洗到瓣膜的任何顶袋之外而去除气泡。在一些情况下,可以在将瓣膜和装载装置560小心地浸没在盐水/水浴中的情况下执行将假体瓣膜装载到瓣膜装载装置560中的过程以去除装载装置560内的所有滞留气泡。
在替代的程序中,在外漏斗联接到瓣膜保持管525之前,可以将瓣膜安置在外漏斗564中。外漏斗564和定心锥562可以联接在一起,如上所述,并且外漏斗564可以经由快速连接联接器541和543联接到瓣膜保持管525。在一些情况下,在漏斗组件515(外漏斗和顶帽组件596)联接到瓣膜保持管525之前,瓣膜保持管525可以经由快速连接联接器550和551联接到手柄组件565。在其他情况下,瓣膜保持管525可以在漏斗组件515与其联接之前先联接到手柄组件565。
在漏斗组件515(具有装载在其中的假体瓣膜)联接到瓣膜保持管525和手柄组件565的情况下,整个组件可以从固定件移除,翻转倒置,并且以竖直取向放回到固定件中,此时手柄组件565的远端处于顶部并且漏斗组件515处于底部。在此程序期间盐水冲洗可以继续使用(例如,通过端口548引入)以将瓣膜从漏斗组件515移动到瓣膜保持管525。为了将假体瓣膜从漏斗组件515(即,外漏斗564/定心锥562)移动到瓣膜保持管525的内部区域中,主装载旋钮或手柄567被致动(例如旋转),这相应地使装载导螺杆566在箭头A的方向上相对于手柄567移动,如图23所示。当装载导螺杆566在箭头A的方向上移动时,由于瓣膜保持管525经由快速连接联接器550、551联接到装载导螺杆566并且经由快速连接联接器541、543联接到漏斗组件515,因此瓣膜保持管525和漏斗组件515也与装载导螺杆566一起在箭头A的方向上移动,如图24所示。图23示出了在朝近侧移动之前的瓣膜保持管525和漏斗组件515以及装载导螺杆566,并且图24示出了在沿着箭头A的方向相对于手柄组件565朝近侧移动之后的瓣膜保持管525和漏斗组件515以及装载导螺杆566。
由于系绳(附接到瓣膜)经由系绳穿刺构件568固定到手柄组件565(和手柄567),假体瓣膜(未示出)(布置在漏斗组件515内)保持在相对于手柄567的固定位置。类似地,定心杆561由于由定心杆固定旋钮569保持而保持在固定位置,所述定心杆固定旋钮相对于手柄567轴向地保持固定。因此,当瓣膜保持管525和漏斗组件515在箭头A的方向上移动时,假体瓣膜(和定心杆561)不移动,并且漏斗组件515和瓣膜保持管525在假体瓣膜上移动,直到假体瓣膜被捕获在瓣膜保持管525的内部区域内。在假体瓣膜处于瓣膜保持管525内的情况下,瓣膜保持管525可以从外漏斗564和手柄组件565断开。瓣膜保持管525能够随后如本文中所述联接到瓣膜递送装置(例如100、200)以递送到心脏。
尽管将假体瓣膜从布置在漏斗组件515内移动到布置在瓣膜保持管525内的以上方法包括在箭头A的方向上移动装载导螺杆566从而相应地在箭头A的方向上移动漏斗组件515和瓣膜保持管525,但是在替代的方法中,装载导螺杆566可以被致动以在相反的方向(即,在图23和24中的箭头B的方向)上移动。在这样的方法中,由于系绳被联接/固定到系绳保持机构568,并且保持机构与致动器/手柄567处于固定关系,因此如果致动器/手柄567在箭头B的方向上移动,则系绳将与致动器/手柄567一起在相同的方向上移动。因此,系绳(联接到瓣膜)可以将假体瓣膜从漏斗组件515拉出并且在瓣膜保持管525内牵拉。
图25示出了瓣膜装载装置560'的替代实施例,其可以包括与瓣膜装载装置560相同或相似的特征并且可以在功能上相同或相似。例如,瓣膜装载装置565'包括具有外漏斗564'和内漏斗562的漏斗组件515'、瓣膜保持管525'以及具有装载导螺杆566'的手柄组件565'。图25示出了在被致动以在箭头A的方向上移动瓣膜保持管525'和漏斗组件515'之后的瓣膜装载装置。在上面通过引用并入的临时申请第62/148,579号和第62/312,136号中描述了关于瓣膜装载装置560'的更多细节。
图26是示出根据一个实施例将假体二尖瓣部署到心脏中的方法的流程图。在670,将假体二尖瓣装载到瓣膜装载装置(例如160、560)中并且在瓣膜装载装置内从偏压膨胀配置移动到压缩配置。在672,在保持压缩配置的同时将假体二尖瓣转移到瓣膜保持管(例如125、225、525)。在674,将其中布置有处于压缩配置的假体二尖瓣的瓣膜保持管联接到瓣膜递送装置(例如100、200)的手柄组件的远端部分。在将瓣膜保持管联接到手柄组件的远端之前,联接到假体二尖瓣的系绳可以穿过手柄组件的管腔并且穿过手柄组件的系绳保持机构(例如127、227)的管腔。在676,可以将瓣膜保持管联接到瓣膜递送装置的导管组件(例如130、230)的接头。因此,瓣膜保持管的近端被联接到手柄组件,并且瓣膜保持管的远端被联接到导管组件。在678,将导管组件的远端插入心脏中并且延伸到心脏的左心房。例如,在瓣膜保持管联接到导管组件和手柄组件的情况下,导管组件的鞘的远端可以插入心脏中。在680,致动近侧致动器旋钮,使得假体二尖瓣朝远侧移动到瓣膜保持管之外并进入递送鞘的远端部分。在682,致动远侧致动器旋钮以朝近侧移动递送鞘,使得假体二尖瓣布置在递送鞘的远端的外部并且布置在心脏的左心房内。当在保持管和递送鞘内未被压缩时,假体二尖瓣在心脏内移动到偏压膨胀配置。
图27是根据实施例的套件的示意图。在一些实施例中,外科套件705可以包括:递送装置700,其可以是例如本文所述的递送装置(例如递送装置100、200、300);以及瓣膜装载装置760(例如,瓣膜装载装置160、560)。套件705也能够可选地包括再捕获装置710(例如,410、1010、1110、1210、1310)。套件705能够可选地包括经导管假体瓣膜740(例如,假体二尖瓣)和/或将经导管瓣膜740固定在心脏内的适当位置的心外膜垫784和/或如本文所述的扩张器装置754(例如,扩张器装置354、854、954)和/或导丝(在图23中未示出)中的一个或多个。套件705也可以包括无菌包装794,套件的部件能够密封在所述无菌包装中以便运输。
图28-42示出了可以与递送装置(对于图28-42而言未示出)例如上述的递送装置100、200、300一起使用的扩张器装置的另一实施例。扩张器装置854可以通过导管组件的端口例如上述的导管230的端口237或导管组件330的端口337插入。止血阀(未示出)可以联接到侧端口,使得扩张器装置854在通过侧端口227、337插入时穿过止血阀。
如图28的侧视图所示,扩张器装置854包括具有锥形远端的可膨胀的扩张器球囊构件834(在本文中也称为“球囊构件”),所述锥形远端可以为递送鞘(未示出)(例如上述的递送鞘336)提供导入,并且用于帮助打开或扩大在心脏的心外膜表面处且通过心室的壁的进入开口(例如在心尖处)。球囊构件834在图28、30和34-42中示出为处于部分充胀配置或几乎完全充胀配置。
球囊构件834经由长形充胀管855联接到球囊歧管856。球囊歧管856可以与上述的球囊歧管356相同或相似,并且包括充胀端口888和导丝端口889。充胀端口888可以联接到用于充胀和放泄球囊构件834的充胀介质源。长形充胀管855(在本文中也称为“充胀管”)联接到球囊歧管856和球囊构件834,正如下文更详细地描述的那样。充胀管855限定与球囊构件834的内部区域流体连通的充胀管腔,使得充胀介质可以行进通过充胀端口888、通过充胀管腔、并进入球囊构件834。扩张器装置854还包括长形导丝管857(在本文中也称为“导丝管”),所述导丝管联接到球囊构件834的远侧颈部分839(在下面更详细地描述)并且延伸通过球囊构件834、充胀管855的充胀管腔并从充胀管855的近端伸出。导丝管857限定导丝管腔,导丝(未示出)可以通过所述导丝管腔插入。导丝的直径可以是例如0.035英寸。
图29是沿着图28的线B-B截取的横截面图。如图28和29所示,球囊歧管856包括歧管接头858和锥形应变消除部分859,该锥形应变消除部分消除充胀管855相对于相对刚性的歧管接头858的弯曲应变。歧管接头858和应变消除部分859可以例如通过粘合剂而例如在位置809处联接在一起。
如图28和29所示,运输心轴853可以通过导丝管857的导丝管腔插入,并且包括联接到近侧旋钮847的长形构件849。长形构件849可以通过球囊歧管856和长形导丝管857插入,直到远端布置在充胀管857的远端的外部,如图28所示。运输心轴853可以用于保持扩张器装置854的各种部件的对准,并且减少或消除在使用扩张器装置854之前导丝管857塌缩的可能性。在该实施例中,运输心轴853的近侧旋钮847例如可以用快速连接联接器(譬如路厄锁联接机构)联接到球囊歧管856。例如,近侧旋钮847可以包括路厄锁特征852,其可以配合地联接到球囊歧管856的导丝端口889的路厄锁特征890。在使用扩张器装置854之前,可以通过从导丝端口889的路厄锁特征890释放路厄锁特征852并且朝近侧牵拉运输心轴853使得运输心轴853从长形导丝管857和球囊歧管856移除而从扩张器装置854移除运输心轴853。
图30是处于部分充胀/膨胀配置的球囊构件834的侧视图。球囊构件834包括分别具有第一外径和第二外径的第一主体部分831和第二主体部分833。第二外径大于第一外径。球囊构件834的远端部分包括锥形凹远侧部分835和远侧颈部分839。球囊构件834的近端部分包括圆锥形部分838和近端颈部分881。
球囊构件834和球囊构件834的各个部分可以具有任意合适的长度。例如,凹远侧部分835、第一主体部分831和第二主体部分833可以具有组合长度L1。在一些实施例中,长度L1可以是例如约3.723英寸。凹远侧部分835可以具有长度L2,第一主体部分831可以具有长度L3,并且第二主体部分833可以具有长度L4。在一些实施例中,长度L2可以是例如约1.350英寸,长度L3可以是例如约1.25英寸,并且长度L4可以是例如约0.75英寸。另外,在一些实施例中,锥形凹远侧部分835可以包括亲水涂层。
在一些实施例中,远侧颈部分839可以具有例如可约为0.30英寸的长度L5,并且近侧颈部分881可以具有例如可约为0.60英寸的长度L6。圆锥形部分838能够以任意合适的角度从第二主体部分833渐缩到近侧颈部分881。例如,圆锥形部分838相对于近侧颈部分838的锥度可以是角θ1。在一些实施例中,角θ1可以是例如25°。当处于未充胀配置时,如图31所示,球囊构件834能够折叠或塌缩到较小的尺寸以便插入递送鞘中。
在一些情况下,取决于球囊构件834的充胀压力,当球囊构件834膨胀到充胀配置时,凹远侧部分835可以膨胀到非凹形状。在这样的情况下,远侧部分835可以为锥形,但不是凹形。在一些实施例中,球囊构件834可以配置成使得球囊中的目标压力在充胀配置中为2-3ATM以供使用。在2-3ATM的压力下,凹远侧部分835可以配置成保持凹形或稍微变直的锥形。
图32是图30中的细部C的放大图。如图32所示,球囊构件834包括在第一主体部分831和第二主体部分833之间的第一过渡部分831A和第二过渡部分833A。第一过渡部分831A和第二过渡部分833A提供在第一主体部分831和第二主体部分833之间的平滑且圆弧状(radiused)的过渡。
图33是图30所示的球囊构件834的远端视图。如图33所示,并且如上所述,第二主体部分833的外径大于第一主体部分831的外径。例如,在一些实施例中,第二主体部分833可以具有约0.455英寸的外径,并且第一主体部分831可以具有约0.445英寸的外径。第一外径可以选择成使得当第一主体部分831布置在鞘(例如上述的鞘336)内时,在凹远侧部分835和鞘336之间为平滑过渡。另外,第一主体部分831可以包括亲水涂层。(第二主体部分833)的第二外径可以选择成使得在膨胀配置中,当布置在递送鞘(例如上述的鞘336)内时,第二主体部分833可以形成抵靠递送鞘的内表面的密封。换句话说,当不受约束且处于膨胀/充胀配置时,第二主体部分833的第二外径可以大于鞘的内径。
图34是沿着图30所示的线D-D截取的横截面图。如图34所示,远侧颈部分839具有外径D1和内径D2。在一些实施例中,外径D1可以是例如约0.064英寸,并且内径D2可以是例如约0.056英寸。
图35是沿着图30所示的线E-E截取的横截面图。如图35所示,近侧颈部分881具有外径D3和内径D4。在一些实施例中,外径D3可以是例如约0.1075英寸,并且内径D4可以是例如约0.103英寸。
图36是球囊构件834、长形充胀管855和长形导丝管857的侧视图。如上所述,长形导丝管857布置为穿过球囊充胀管855。长形导丝管的远侧部分857在球囊构件834的远侧延伸,并且长形导丝管857的近侧部分在长形充胀管855的近端的近侧以长度L7延伸。长度L7可以是能够与球囊充胀歧管856(在图28和29中示出)接合的任意合适的长度,以使得由长形导丝管857限定的导丝管腔能够经由导丝端口889进入。例如,在一些实施例中,长度L7可以是约0.668英寸。
图37是图36中标识的细部F的放大图。如图37所示,球囊构件834的远侧颈部分839可以经由粘合部883联接到长形导丝管857。可以施加粘合部883,以使其在长形导丝管857的外表面和远侧颈部分839的外表面之间形成平滑的锥形过渡区域。粘合部883的锥度可以处于长度L8上,在一些实施例中,长度L8可以是例如约0.04英寸。
图38是沿着图32中的线G-G截取的图37的放大细部的横截面图。如图38所示,将长形充胀管855联接到球囊构件834的远侧颈部分839的粘合部883也可以布置在介于远侧颈部分839的内表面和长形导丝管857的外表面之间的长度L9上。在一些实施例中,长度L9可以介于例如约0.160英寸至约0.320英寸之间。
另外,如图38所示,长形导丝管857可以包括在远端处的第一部分885(也称为远端部分885),其可以由比长形导丝管857的剩余的第二部分807更软的材料形成以提供无创伤的远端以减少当插入患者的心脏时对周围组织的潜在创伤。例如,在一些实施例中,远端部分885可以由低硬度材料形成,譬如交联尼龙、聚氨酯等。长形导丝管857可以布置在远侧颈部分839内,使得长形导丝管857的远端部分885与球囊构件834的远侧颈部分839以长度L10重叠。在一些实施例中,长度L10可以是例如约0.080英寸。导丝管857的剩余的第二部分807可以形成有多个层以提供改进的导丝移动、抗扭结性和可粘结性。例如,在一些实施例中,导丝管857的剩余的第二部分807可以形成有三层构造,包括PTFE/PI复合材料的内层、例如由304V不锈钢形成的线圈材料、以及由医用7233SA01形成的外材料层。导丝管857的第一或远端部分885可以具有比导丝管857的第二部分807的外径更大的内径,使得第二部分807的远端可以被接收在远端部分885的管腔内。第一或远端部分885也可以用布置在剩余部分的外表面和远端部分885之间的粘合部联接到导丝管857的第二部分。
图39是联接到长形充胀管855的球囊构件834的侧视图。如图39所示,球囊构件834的近侧颈部分881可以联接到长形充胀管855。也如图所示,长形充胀管855可以具有长度L11。在一些实施例中,长度L11可以是例如约11.12英寸。长形充胀管855可以经由粘合部886联接到球囊构件834。
图40是图39中的细部H的放大图。如图40所示,长形充胀管855的远端部分871布置在球囊构件834的近侧颈部分881内。近侧颈部分881可以具有直径D5,该直径D5在一些实施例中可以是例如约0.116英寸或更小。长形充胀管855的远端部分871可以具有比充胀管855的剩余部分873的直径D7更小的外径D6,使得其可以插入球囊构件834的近侧颈部分881中(如图41和42所示)。例如,在一些实施例中,远端部分871的直径D6可以是0.099英寸,且充胀管855的剩余部分873的直径D7可以是例如0.113英寸。在一些实施例中,远端部分871的内径可以与充胀管855的剩余部分873的内径相同,如图41所示。在一些实施例中,充胀管855的远端部分871和剩余部分873可以形成为一体或整体形成的部件。在一些实施例中,充胀管855的远端部分871和剩余部分873可以是联接在一起的独立部件。
如图40所示,在一些实施例中,充胀管855的远端部分871能够以长度L13布置到球囊构件834的近侧颈部分881中。在一些实施例中,长度L13可以是例如至少约0.125英寸。粘合部886可以布置在球囊构件834的近侧颈部分881和长形充胀管855的远端部分871之间以将近侧颈部分881牢固地联接到长形充胀管855。在一些实施例中,远端部分871插入近侧颈部分881中,使得在颈部分881的近端和充胀管885的较大直径部分873之间存在小间隙,并且粘合部886可以布置在该间隙内并且沿着这两个部件的外表面平滑过渡。粘合部886可以提供近侧颈部分881的外表面和长形充胀管855的外表面之间的平滑的锥形过渡。在一些实施例中,粘合部886可以布置在长度L12上,所述长度L12可以是例如约0.02英寸。
在使用中,如上所述,扩张器装置854可以与递送装置(例如上述的递送装置100、200、300)结合使用以在心脏内递送和部署假体二尖瓣。当处于未膨胀配置(未示出)时,扩张器装置854可以被折叠或塌缩并且通过联接到导管组件的接头的端口(例如,导管组件230、330的接头232、332的端口237、337)的止血阀(未示出)插入。扩张器装置854可以在递送鞘236、336的管腔内朝远侧推送或移动,直到球囊构件834的凹远侧部分835延伸到递送鞘236、336的远端的远侧并且第一主体部分831和第二主体部分833布置在递送鞘236、336内。在一些实施例中,扩张器装置854可以包括在充胀管855的外部上的标记875(参见图39)以帮助将扩张器装置854在递送鞘236、336内进行定位。例如,标记875可以布置在充胀管855上的位置处,使得在扩张器装置854插入递送鞘中的情况下,当标记875到达联接到递送鞘的侧端口的止血阀时,球囊834将定位在递送鞘内的正确位置处。
在扩张器装置854联接到导管组件(例如,布置在导管组件230、330的递送鞘236、336内)的情况下,导管组件可以联接或对接递送装置的手柄组件(例如递送装置200、300的手柄组件220、320)。在导管组件(例如230、330)对接/联接到递送装置(例如200、300)的手柄组件(例如220、320)之前或之后,运输心轴853可以从导丝端口889脱离并且从长形导丝管857移除。在将导管组件(具有与其联接的扩张器装置)联接到手柄组件之后,递送鞘可以被清除空气,并且球囊构件834可以从未充胀配置(例如,折叠或塌缩配置)膨胀到充胀配置,使得第二主体部分833形成抵靠递送鞘236、336的内表面的密封。整个组件可以经由长形导丝管857的管腔的远端装载在导丝(未示出)上。例如,导丝可以插入患者的心脏中并且延伸到患者体外,并且导丝的近端可以插入导丝管857的远端中并且从导丝管857的近端伸出。在导丝通过其中插入的情况下,扩张器装置854的远端部分和递送鞘236、336可以通过患者的心脏的心外膜表面(例如,在心尖处)插入并且延伸通过左心室的壁进入心脏的左心房。球囊构件834的锥形远端有助于打开或扩大在心外膜表面处的进入开口。当递送鞘236、336处于期望位置时,球囊构件834可以放泄,并且扩张器装置854可以经由端口237、337从递送装置200、300移除。然后递送装置200、300可以被致动以递送假体二尖瓣,正如上面参考先前实施例所述。
图43是以横截面示出的与鞘936接合的球囊构件934的侧视图。球囊构件934可以类似于球囊构件834。例如,扩张装置934包括分别具有第一外径和第二外径的第一主体部分931和第二主体部分933。第二外径大于第一外径。球囊构件934还包括锥形凹远侧部分935和远侧颈部分939。在近侧,球囊构件934包括圆锥形近侧部分938和近侧颈部分981。
在该实施例中,球囊构件934还包括扩大部分987。扩大部分987可以成形为环并且在充胀时(如图43所示)相对于第一主体部分931具有增大的外径。鞘936可以与上述的递送鞘236或336相同或相似。如图43所示,鞘936可以抵接扩大部分987的近侧。由于鞘936与扩大部分987的抵接,因此球囊934和鞘936之间的过渡是平滑的。换句话说,当球囊构件934和鞘936移动通过心外膜表面时,组织将不会卡在鞘936的远端上。另外,扩大部分987可以用作对鞘936的限制件或止动件,使得当球囊构件934处于膨胀配置时,鞘936不能朝远侧平移超出扩大部分987。
图44-46示出了可以用于再捕获已部署/植入的假体心脏瓣膜(例如,假体二尖瓣)以重新定位和/或收回/移除假体心脏瓣膜的再捕获装置的另一实施例。再捕获装置1010包括联接到手柄组件1020的外鞘1044、可操作地联接到手柄组件1020并且可移动地布置在外鞘1044的管腔内的外扩张器1042、以及可移动地布置在外鞘1044的管腔内并且可操作地联接到手柄组件1020的内扩张器1046。在该实施例中,再捕获装置1010包括加入到致动器组件中的系绳保持机构,正如下文更详细地描述的那样。内扩张器1046限定管腔,所述管腔可以接收从假体瓣膜(未示出)延伸的系绳,并且可以在再捕获程序期间接收假体瓣膜的一部分。内扩张器1046还包括配置成接合被植入心脏内的假体瓣膜的远侧末端,正如下文更详细地描述的那样。
如图46所示,手柄组件1020包括壳体1022、联接到壳体1022并且可操作地联接到驱动轴机构1006的致动器旋钮1026。驱动轴机构1006可操作地联接到内扩张器1046并且包括在再捕获程序期间卷绕(从假体瓣膜延伸的)系绳的卷绕壳体1077,正如下文更详细地描述的那样。第一弹簧1091联接到长形管1079和内扩张器1046。第一弹簧1091可以是例如螺旋弹簧。外扩张器1042联接到长形杆1093,所述长形杆联接到一对带状弹簧1092,所述带状弹簧可以是例如恒力弹簧或可变力弹簧。
为了用再捕获装置1010捕获假体心脏瓣膜,从假体瓣膜延伸的系绳可以通过内扩张器1046的远端插入,延伸通过内扩张器1046的管腔、通过长形管1079、通过卷绕壳体1077、通过海波管1018,并且从再捕获装置1010的近端伸出。Touhy阀1017联接到海波管1018,并且配置成在再捕获程序期间当卷绕系绳时将系绳夹紧到其上并提供阻力,如下所述。阀1017也可以提供密封以允许系统的盐水冲洗。
在系绳穿过再捕获装置1010的情况下,内扩张器1046的远侧末端可以沿着系绳朝远侧移动以接合假体瓣膜的近侧部分。致动器1026能够随后被致动(例如,旋转或转动旋钮)以使内扩张器1046相对于外扩张器1042朝近侧移动。当内扩张器1046朝近侧移动时,系绳在卷绕壳体1077内被卷绕,并且瓣膜相应地将被朝近侧牵拉。例如,系绳可以从两个方向卷绕到卷绕壳体1077中。一个方向是来自系绳延伸到海波管1018中的方向并且另一方向是系绳从长形管1079进入壳体1077的方向。内扩张器1046可以继续被致动以相对于外扩张器1042朝近侧移动,从而在外扩张器1042的管腔内部分地牵拉假体瓣膜,直到弹簧1091完全塌缩并完全下压在外扩张器1042上并且弹簧1091上的力增大。此时,瓣膜已被部分捕获,并且如果需要可以在心脏内进行重新定位。
为了完全捕获和收回/移除瓣膜,致动器1026可以继续被致动(例如,旋转/转动),并且由于弹簧1091抵靠外扩张器1042的力,外扩张器1042将开始与内扩张器1046以及与其联接的瓣膜一起朝近侧移动。换句话说,内扩张器1046相对于外鞘1044朝近侧牵拉外扩张器1042。外鞘1044相对于手柄组件1020保持固定。当外扩张器1042朝近侧移动时,长形杆1093与带状弹簧1092接合并且在狭槽1094内滑动。经由长形杆1093联接到外扩张器1042的弹簧1092可以控制用于朝近侧移动外扩张器1042的力。在一些实施例中,弹簧1092可以提供例如8-10磅(lbs)的恒定力。在一些实施例中,弹簧1092可以提供可变的力。例如,可能期望在外扩张器1042的致动开始时提供更大的弹簧力。随着外扩张器1042朝近侧移动,瓣膜被完全牵拉到外鞘1044的管腔中并且移动到塌缩配置。能够随后通过从患者的身体移除其中具有瓣膜的再捕获装置1010而从心脏移除/收回瓣膜。
图47-49示出了可以用于再捕获已部署/植入的假体心脏瓣膜(例如,假体二尖瓣)以重新定位和/或收回/移除假体心脏瓣膜的再捕获装置的另一实施例。再捕获装置1110包括联接到手柄组件1120的外鞘1144、可操作地联接到手柄组件1120并且可移动地布置在外鞘1144的管腔内的外扩张器1142、以及可移动地布置在外扩张器1142的管腔内并且可操作地联接到手柄组件1120的内扩张器1146。与先前实施例一样,再捕获装置1110包括加入到致动器组件中的系绳保持机构,正如下文更详细地描述的那样。内扩张器1146限定管腔,所述管腔可以接收从假体瓣膜(未示出)延伸的系绳并且可以在再捕获程序期间接收假体瓣膜的一部分。内扩张器1146还包括配置成接合植入心脏内的假体瓣膜的远侧末端,正如下文更详细地描述的那样。
如图48所示,手柄组件1120包括壳体1122、联接到壳体1122并且可操作地联接到驱动轴机构1106的致动器旋钮1126。驱动轴机构1106可操作地联接到内扩张器1146并且包括在再捕获程序期间卷绕(从假体瓣膜延伸的)系绳的卷绕壳体1177,正如下文更详细地描述的那样。第一弹簧1191联接到长形管1179和内扩张器1146。第一弹簧1191可以是例如螺旋弹簧。在该实施例中,外扩张器1142联接到长形杆1179,所述长形杆还联接到第二弹簧1192,所述第二弹簧也可以例如是螺旋弹簧。弹簧1191具有比第二弹簧1192更软的弹簧系数(spring rate)。释放杆1195联接到驱动轴机构1106,并且可以防止驱动机构1106在再捕获程序期间向后移动。然而,如果需要,释放杆1195可以被致动以在需要时允许驱动机构进行支援。
为了用再捕获装置1110捕获假体心脏瓣膜,从假体瓣膜延伸的系绳可以通过内扩张器1146的远端插入,延伸通过内扩张器1146的管腔、通过长形管1179、通过卷绕壳体1177、通过海波管1118,并且从再捕获装置1110的近端伸出。Touhy阀117联接到海波管1118,并且配置成在再捕获程序期间当卷绕系绳时将系绳夹紧到其上并且提供阻力,如下所述。阀1117也可以提供密封以允许系统的盐水冲洗。
在系绳穿过再捕获装置1110的情况下,内扩张器1146的远侧末端可以沿着系绳朝远侧移动以接合假体瓣膜的近侧部分。致动器1126能够随后被致动(例如,旋转或转动旋钮),以使内扩张器1146相对于外扩张器1142朝近侧移动。当内扩张器1146朝近侧移动时,系绳被卷绕在卷绕壳体1177内,并且瓣膜相应地被朝近侧牵拉。例如,系绳可以从两个方向卷绕到卷绕壳体1177中。一个方向是来自系绳延伸到海波管1118中的方向并且另一方向是系绳从长形管1179进入壳体1177的方向。内扩张器1146可以继续被致动以相对于外扩张器1142朝近侧移动,从而在外扩张器1142的管腔内部分地牵拉假体瓣膜,直到弹簧1191完全塌缩并完全下压在外扩张器1142上并且弹簧1191上的力增大。此时,瓣膜已被部分捕获,并且如果需要可以在心脏内进行重新定位。
为了完全捕获和收回/移除瓣膜,致动器1126可以继续被致动(例如,旋转/转动),这将促使外扩张器1142开始与内扩张器1146以及与其联接的瓣膜一起朝近侧移动。换句话说,内扩张器1146相对于外鞘1144朝近侧牵拉外扩张器1142。外鞘1144相对于手柄组件1120保持固定。当外扩张器1142朝近侧移动时,外扩张器1142施加抵抗第二弹簧1192的力。第二弹簧1192可以帮助控制用于朝近侧移动外扩张器1142的力。在一些实施例中,弹簧1192可以提供例如8-10磅(lbs)的恒定力。在一些实施例中,弹簧1191和1192均可以提供可变的力。随着外扩张器1142朝近侧移动,瓣膜被完全牵拉到外鞘1144的管腔中并且移动到塌缩配置。能够随后通过从患者的身体移除其中具有瓣膜的再捕获装置1110而从心脏移除/收回瓣膜。
图50-52示出了可以用于再捕获已部署/植入的假体心脏瓣膜(例如,假体二尖瓣)以重新定位和/或收回/移除假体心脏瓣膜的再捕获装置的另一实施例。再捕获装置1210包括联接到手柄组件1220的外鞘1244、可操作地联接到手柄组件1220并且可移动地布置在外鞘1244的管腔内的外扩张器1242、以及可移动地布置在外鞘1244的管腔内并且可操作地联接到手柄组件1220的内扩张器1246。内扩张器1246限定管腔,所述管腔可以接收从假体瓣膜(未示出)延伸的系绳(未示出)并且可以在再捕获程序期间接收假体瓣膜的一部分。内扩张器1246还包括配置成接合被植入心脏内的假体瓣膜的远侧末端,正如下文更详细地描述的那样。在该实施例中,再捕获装置1210包括系绳保持机构1227,所述系绳保持机构包括可以穿刺系绳并且将系绳固定到再捕获装置1210的钉扎构件。
如图52所示,手柄组件1220包括壳体1222、可操作地联接到内扩张器1246的第一致动器旋钮1226、以及可操作地联接到外扩张器1242的第二致动器旋钮1228。长形管1279联接到内扩张器1246、延伸通过壳体1222并且联接到系绳保持机构1227。
为了用再捕获装置1210捕获假体心脏瓣膜,从假体瓣膜延伸的系绳可以通过内扩张器1246的远端插入,延伸通过内扩张器1246的管腔、通过长形管1279,并且由保持机构1227钉扎在手柄组件1220的近端处。当系绳穿过再捕获装置1210时,内扩张器1246的远侧末端可以沿着系绳朝远侧移动以接合假体瓣膜的近侧部分。第一致动器1226能够随后被致动(例如,旋转或转动旋钮)以使内扩张器1246相对于外扩张器1242朝近侧移动。当内扩张器1246朝近侧移动时,保持机构1227以及与其联接的系绳与内扩张器1246一起被牵拉,并且瓣膜相应地被朝近侧牵拉。当瓣膜被朝近侧牵拉时,瓣膜的一部分将被牵拉到外扩张器1242的管腔中,并且在管腔内移动到塌缩配置。此时,瓣膜已被部分捕获,并且如果需要可以在心脏内进行重新定位。
为了完全捕获和收回/移除瓣膜,第二致动器旋钮1228可以被致动(例如,旋转/转动),这将促使外扩张器1242开始与内扩张器1246以及与其联接的瓣膜一起朝近侧移动。外鞘1244相对于手柄组件1220保持固定。外扩张器1242可以朝近侧移动,直到瓣膜完全布置在外鞘1244内并且移动到塌缩配置。能够随后通过从患者的身体移除其中具有瓣膜的再捕获装置1210而从心脏移除/收回瓣膜。
图53-56示出了可以用于再捕获已部署/植入的假体心脏瓣膜(例如,假体二尖瓣)以重新定位和/或收回/移除假体心脏瓣膜的再捕获装置的另一实施例。再捕获装置1310包括联接到手柄组件1320的外鞘1344、可操作地联接到手柄组件1320并且可移动地布置在外鞘1344的管腔内的外扩张器1342、以及可移动地布置在外扩张器1342的管腔内并且可操作地联接到手柄组件1320的内扩张器1346。内扩张器1346限定管腔,所述管腔可以接收从假体瓣膜(未示出)延伸的系绳(未示出)并且可以在再捕获程序期间接收假体瓣膜的一部分。内扩张器1346还包括配置成接合被植入心脏内的假体瓣膜的远侧末端,正如下文更详细地描述的那样。在该实施例中,再捕获装置1310包括系绳保持机构1327,所述系绳保持机构包括可以穿刺系绳并且将系绳固定到再捕获装置1310的钉扎构件。
如图55和56所示,手柄组件1320包括壳体1322、长形螺纹构件1308、以及致动器旋钮1326。致动器旋钮1326可操作地联接到内扩张器1346和外扩张器1342。长形管1379联接到致动器旋钮1326并且也联接到内扩张器1346和外扩张器1342,并且延伸通过壳体1322。致动器旋钮1326可以通过旋转致动器旋钮1326被致动,这促使致动器旋钮沿着螺纹构件1308行进。系绳保持机构1327可操作地联接到致动器旋钮1326,使得当致动器旋钮被致动(例如,旋转/转动)时,系绳保持机构1327与致动器旋钮1326一起相对于螺纹构件1308移动。如图53所示,系绳保持机构1327的钉扎构件从长形螺纹构件1308的狭槽伸出,并且当致动器旋钮1326被致动时,系绳保持机构1327可以沿着狭槽1307移动。在一些实施例中,致动器旋钮1326和/或螺纹构件1308包括仅允许致动器旋钮1326在一个方向上沿着螺纹构件1308行进的单向机构。这可以防止致动器旋钮1326在再捕获程序期间意外地朝远侧往回移动。释放杆1319联接到外扩张器1342,并且配置成将外扩张器1342可释放地固定在相对于外鞘1344的固定位置,正如下文更详细地描述的那样。
为了用再捕获装置1310捕获假体心脏瓣膜,从假体瓣膜延伸的系绳可以通过内扩张器1346的远端插入,延伸通过内扩张器1346的管腔、通过长形管1379,并且由保持机构1327钉扎。在系绳穿过再捕获装置1310的情况下,内扩张器1346的远侧末端可以沿着系绳朝远侧移动以接合假体瓣膜的近侧部分。在释放杆1319接合(例如,推入)以使得外扩张器1342不能相对于外鞘1344移动的情况下,致动器旋钮1326可以被致动(例如,旋转或转动旋钮)以使内扩张器1346相对于外扩张器1342和相对于外鞘1344朝近侧移动。随着内扩张器1346朝近侧移动,保持机构1327以及与其联接的系绳与内扩张器1346一起朝近侧移动,并且瓣膜将相应地朝近侧移动以使得瓣膜的一部分被牵拉到外扩张器1342的管腔中,并且在外扩张器1342的管腔内移动到塌缩配置。此时,瓣膜已被部分捕获,并且如果需要可以在心脏内进行重新定位。
为了完全捕获和收回/移除瓣膜,可以牵拉或移动释放杆1319以从外鞘1344释放外扩张器1342。致动器旋钮1326可以被致动以沿着长形螺纹构件进一步朝近侧行进,这将促使外扩张器1342与内扩张器1346以及与其联接的瓣膜一起朝近侧移动。外鞘1344相对于手柄组件1320保持固定。外扩张器1342可以朝近侧移动,直到瓣膜完全布置在外鞘1344的管腔内并且移动到塌缩配置。能够随后通过从患者的身体移除其中布置有瓣膜的再捕获装置1310而从心脏移除/收回瓣膜。
正如上面针对再捕获装置410所述的那样,本文所述的再捕获装置中的每一个(即,410、1010、1110、1210、1310)都包括再捕获装置的两阶段致动,其允许受控地捕获植入心脏内的假体瓣膜以重新定位和/或移除/收回假体瓣膜。瓣膜的框架的近侧部分可以首先充分塌缩以使框架的一部分布置在外扩张器(例如,442、1042、1142、1242、1342)的管腔内,并且随后当其移动到外鞘(例如,444、1044、1144、1244、1344)的管腔中时可以转变成更完全的塌缩配置。
尽管上面已经描述了各种实施例,但是应当理解,它们仅以示例的方式呈现,而不是限制性的。在上述方法指示某些事件以某种顺序发生的情况下,某些事件的顺序可以被修改。另外,某些事件在可行的情况下能够在并行过程中并发地执行、以及如上所述顺序地执行。
在上述的示意图和/或实施例指示以某些取向或位置布置某些部件的情况下,部件的布置可以被修改。尽管已经特别地图示和描述了实施例,但是应当理解,可以进行形式和细节上的各种变化。除了相互排斥的组合以外,本文所述的装置和/或方法的任何部分能够以任意的组合方式进行组合。本文所述的实施例可以包括所描述的不同实施例的功能、部件和/或特征的各种组合和/或子组合。
Claims (19)
1.一种用于递送假体心脏瓣膜的装置,其包括:
导管组件,所述导管组件包括限定递送管腔的长形鞘和设置在所述长形鞘的近端处的接头;
限定内部区域的瓣膜保持管,所述内部区域配置成在其中接收假体心脏瓣膜,所述瓣膜保持管具有配置成可释放地联接到所述导管组件的所述接头的远端部分;以及
手柄组件,所述手柄组件包括壳体和递送杆,所述壳体的远端部分配置成可释放地联接到所述瓣膜保持管的近端部分,使得所述递送杆的远端在所述假体心脏瓣膜的近侧布置在所述瓣膜保持管的内部区域内,
所述递送杆配置成被致动以相对于所述壳体朝远侧移动,从而将布置在所述瓣膜保持管内的假体心脏瓣膜移出所述瓣膜保持管,并且在所述导管组件的长形鞘内朝远侧移动,
所述导管组件配置成被致动以相对于所述壳体朝近侧移动,使得所述假体心脏瓣膜布置在所述长形鞘的管腔的外部。
2.根据权利要求1所述的装置,其还包括所述假体心脏瓣膜,所述假体心脏瓣膜能够在当布置于所述瓣膜保持管内时和当布置于所述长形鞘内时的塌缩配置以及当不受约束且布置于所述长形鞘的外部时的偏压可膨胀配置之间移动。
3.根据权利要求1所述的装置,其中所述手柄组件包括致动器,所述致动器配置成被致动以使所述递送杆相对于所述手柄组件的壳体朝远侧移动。
4.根据权利要求1所述的装置,其中所述手柄组件包括致动器,所述致动器配置成使所述长形鞘相对于所述壳体朝近侧移动。
5.根据权利要求1所述的装置,其还包括:
系绳保持机构,所述系绳保持机构配置成将联接到布置在瓣膜保持管内的假体瓣膜的系绳固定在相对于所述手柄组件的固定位置。
6.根据权利要求1所述的装置,其中所述壳体包括窗口,所述递送杆包括布置在其上的至少一个标记,所述至少一个标记能够通过所述窗口查看以指示当所述递送杆被致动以使所述假体心脏瓣膜在所述长形鞘内朝远侧移动时所述假体心脏瓣膜的行进距离。
7.根据权利要求1所述的装置,其中所述导管组件的接头包括端口,所述装置还包括:
扩张器装置,所述扩张器装置配置成通过所述端口被接收,穿过所述长形鞘的管腔,并且使得所述扩张器装置的扩张器构件从所述长形鞘的远端伸出,
所述扩张器构件配置成被充胀以向所述装置提供锥形的远端。
8.根据权利要求7所述的装置,其中所述扩张器构件包括锥形部分、具有第一直径的第一部分和具有大于所述第一直径的第二直径的第二部分,所述第一部分位于所述锥形部分与所述第二部分之间。
9.根据权利要求8所述的装置,其中所述锥形部分具有凹形的外表面。
10.根据权利要求1所述的装置,其中当所述导管组件被致动时所述瓣膜保持管配置成与所述导管组件一起朝近侧移动。
11.一种瓣膜装载装置,其包括:
装载漏斗组件,所述装载漏斗组件配置成在其中接收处于塌缩配置的假体心脏瓣膜;
限定内部区域的瓣膜保持管,所述内部区域配置成接收处于塌缩配置的假体心脏瓣膜,所述瓣膜保持管具有配置成可释放地联接到所述装载漏斗组件的第一端部分和第二端部分;以及
手柄组件,所述手柄组件包括手柄和装载导螺杆,所述装载导螺杆配置成可释放地联接到所述瓣膜保持管的第二端部分,
所述手柄组件还包括系绳保持机构和致动器旋钮,所述系绳保持机构配置成将从布置在所述装载漏斗组件内的假体心脏瓣膜延伸的系绳固定在相对于所述手柄组件的固定位置,
所述致动器旋钮可操作地联接到所述装载导螺杆和所述手柄,使得所述手柄和所述装载导螺杆之间的相对移动导致所述装载漏斗组件和所述瓣膜保持管移动远离所述手柄并且导致所述假体心脏瓣膜被布置在所述瓣膜保持管内。
12.根据权利要求11所述的装置,其中所述手柄组件还包括定心杆,所述定心杆的端部分配置成布置在所述装载漏斗组件内和布置于装载漏斗组件中的假体心脏瓣膜的一部分内。
13.根据权利要求11所述的装置,其中所述致动器旋钮配置成在远离所述系绳保持机构的方向上移动所述装载导螺杆,使得所述瓣膜保持管和所述装载漏斗组件相对于所述定心杆和所述假体心脏瓣膜在远离所述系绳保持机构的方向上移动,以使得所述瓣膜保持管移动到将所述假体心脏瓣膜布置在所述瓣膜保持管的内部区域内的位置。
14.根据权利要求11所述的装置,其中所述手柄配置成相对于所述装载导螺杆在朝向所述系绳保持机构的方向上移动,使得瓣膜在朝向所述系绳保持机构的方向上从瓣膜布置在所述装载漏斗组件内的第一位置移动到瓣膜布置在所述瓣膜保持管的内部区域内的第二位置。
15.根据权利要求11所述的装置,其中所述装载漏斗组件包括外漏斗和内漏斗,所述假体心脏瓣膜能够布置在所述外漏斗和所述内漏斗之间以将所述假体心脏瓣膜从偏压膨胀配置移动到塌缩配置。
16.根据权利要求12所述的装置,其中所述定心杆配置成使假体心脏瓣膜在所述装载漏斗组件内居中。
17.一种瓣膜装载方法,其包括:
将假体心脏瓣膜布置到瓣膜装载装置的漏斗组件中;
将所述假体心脏瓣膜在所述漏斗组件内从偏压膨胀配置移动到压缩配置;
将瓣膜保持管联接到所述漏斗组件;
将所述瓣膜保持管联接到所述瓣膜装载装置的手柄组件;
将联接到所述假体心脏瓣膜的系绳可释放地联接到所述瓣膜装载装置的手柄组件;以及
致动联接到所述手柄组件的致动器以使所述瓣膜保持管相对于所述手柄组件移动,使得所述假体心脏瓣膜不再布置在所述漏斗组件内,而是布置在所述瓣膜保持管的内部区域内,同时将所述假体心脏瓣膜保持在压缩配置。
18.根据权利要求17所述的方法,其还包括:
在所述致动之后,将所述瓣膜保持管从所述漏斗组件脱离并且将所述瓣膜保持管从所述手柄组件脱离,其中所述假体心脏瓣膜以压缩配置布置在所述瓣膜保持管的内部区域内。
19.根据权利要求17所述的方法,其中所述致动包括使所述瓣膜保持管和所述漏斗组件相对于所述手柄组件和相对于所述假体心脏瓣膜移动,使得所述假体心脏瓣膜布置在所述瓣膜保持管的内部区域内。
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