CN102497906A - 用于心脏瓣膜的切顶递送系统 - Google Patents
用于心脏瓣膜的切顶递送系统 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
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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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- A61F2/02—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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- 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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- 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
- A61F2220/0025—Connections or couplings between prosthetic parts, e.g. between modular parts; Connecting elements
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Abstract
一种用于将人造心脏瓣膜递送至主动脉瓣环的递送系统和方法。该系统包括递送导管,该递送导管在其上具有操纵机构,用于将球囊可膨胀人造心脏瓣膜以顺行的方式,经由通过左心室尖进入左心室的插管器,递送至主动脉环。该插管器可具有比近端部分更松弛的远端部分,以降低对心脏壁的创伤,同时保留良好的操作区稳定性。递送导管包括仅近端至远端球囊的偏转段,以存进在主动脉环内以合适的朝向定位人造心脏瓣膜。导管手柄中的触发器可被连接至驱动偏转段的偏转线上,同时手柄上的滑动器控制瓣膜推进器的缩回。可将人造心脏瓣膜安装到当前钙化的小叶上,并且也可利用预扩张瓣膜成形术过程。
Description
相关申请
本申请要求在35U.S.C.§119(e)下对2009年7月14日提交的美国临时申请61/225,510号的优先权。
技术领域
本发明涉及用于向心脏递送人造瓣膜的方法和系统。更具体地,本发明涉及如此方法和装置,其用于手术替换心脏瓣膜而不用打开胸腔并且对或不对患者进行旁路手术(bypass),后者被称为“非体外循环下手术(off-pump)”。
背景技术
当天然心脏瓣膜变窄时——通常被称为狭窄,或当天然瓣膜泄漏或回流时,例如当小叶被钙化时,可指示心脏瓣膜替换。当替换瓣膜时,天然瓣膜可被切除并用生物或机械瓣膜进行替换。机械瓣膜要求终身抗凝血药物,以阻止血块形成,并且经常可通过胸部听到瓣膜的滴答声。生物组织瓣膜通常不要求这样的药物。组织瓣膜可从尸体上获得,或可为猪的或牛的,并且通常被附接于固定在患者的心脏瓣膜环上的布覆盖的人造环和/或小叶支撑框架上。
传统心脏瓣膜手术为在通常麻醉下进行的开心过程。穿过患者的胸骨做出切口(胸骨切开术),并且当血流重新经过心脏-肺“心肺”旁路机器(bypass machine)时,患者的心脏停止。瓣膜替换手术是高侵入性手术,具有大量伴随的风险,包括出血、感染、中风、心脏病发作、心率失常、肾衰竭、对麻醉药物的不良反应,以及突然死亡。至少2-5%的患者在手术期间死亡。手术后,由于栓塞和其他与心脏-肺机器相关的因素,患者可短暂地昏沉。手术后最初2-3天在重症监护室内度过,在重症监护室内心脏功能可被密切监视。平均住院在1至2周之间,完全恢复需要再过数周至数月。
近年来,“最小侵入性”手术和介入性心脏学的发展已经鼓励一些研究者探索主动脉心脏瓣膜的经皮替换。以前Fort Lee,N.J.的和现在Edwards Lifesciences of Irvine,CA的部分的经皮瓣膜技术(“PVT”)已经开发了与生物人造瓣膜整合的塑料-或球囊可扩张支架。该支架/瓣膜设备——现在被称为Edwards SapienTM心脏瓣膜——在整个天然患病的瓣膜上展开以永久保持瓣膜打开,由此减少切除天然瓣膜的需要。Edwards SapienTM心脏瓣膜被设计用于在心导管术实验室中,在局部麻醉下利用荧光透视指导进行递送,由此避免全身麻醉和开心手术。SapienTM心脏瓣膜可与RetroFlexTM递送系统一起经股插入,或与AscendraTM递送系统一起切顶插入。在Dehdashtian的美国专利公布2007-0112422号中提供了AscendraTM递送系统的描述。
其他现有技术最小侵入性心脏瓣膜利用自膨胀支架作为锚。在经皮/血管内主动脉瓣替换过程中,相对于冠状动脉口准确放置人造瓣膜是关键的。尽管直到准确放置通过荧光检查被证实支架的近端才从递送系统上释放下来,但一旦被释放,自膨胀支架仍然可能跳开(jump)。因此,经常难以知道支架的末端相对于天然瓣膜和周围结构位于哪里。
Garrison等的美国专利6,425,916号描述了一种用于替换主动脉瓣的两件式设备,其适于通过患者主动脉递送。支架在整个天然瓣膜上进行血管内放置,随后将替换瓣膜放置在支架的腔内并连接至其上。通过在递送期间分离支架和瓣膜——所谓的“两阶段”方法,递送系统的外形可被减小。支架和替换瓣膜的框架都可为球囊可膨胀或自膨胀的。
一些研究者提出通过心室进路(ventricular approach)在主动脉环处植入人造心脏瓣膜。例如,哈佛医学院(Harvard Medical School)Brighamand Women’s Hospital的Christoph H.Huber,以及其他人,已经提出一种过程,其中自膨胀瓣膜支架在主动脉位置处利用直接进入切顶方法植入(例如,Huber等,Direct-access valve replacement a novel approachfor off-pump valve implantation using valved stents.J Am Coll Cardiol2005;46:366-70)。由Huber等进行的临床研究建议仅对具有正常、非钙化小叶的动物使用该过程。最近,Bergheim在美国专利公布2005/0240200号中公开了另一种切顶方法,其中球囊膨胀瓣膜或自膨胀瓣膜可被植入,并且也提出去除狭窄瓣膜或对狭窄瓣膜脱钙。这样的直接进入或“从口进入(port access)”技术,尽管比传统开心手术的侵入性小,但不称为“最小侵入性”,因为该术语现在主要用于指利用细长导管经由脉管系统(即,在血管内)递送的瓣膜。
鉴于与先前已知的用于替换心脏瓣膜而不需要开心手术或心肺旁路手术的技术即最小侵入性过程相关的缺点,需要更耐用和甚至更小侵入性的改进的方法和装置。
发明内容
本发明的优选实施方式提供了心脏瓣膜递送系统,用于向天然瓣膜位点递送人造(即替换)心脏瓣膜,而不需要开胸过程。该递送系统包括具有可操纵部分以便于放置瓣膜的瓣膜递送导管。
根据本申请的一个实施方式,医学导管插管器包括细长管状套,其从近端外壳上向远端延伸,并包含至少一个插管器阀,用于在导管周围进行流体密封。该套具有近端段和远端部分,该近端段具有第一刚度并延伸套长度的至少一半的长度L,该远端部分具有小于第一刚度的第二刚度并具有长度l。期望地,远端部分的长度l的范围在大约4-12cm之间。在一个实施方式中,近端段的长度L为至少24cm,并且远端部分的长度l的范围在大约6-9cm之间。同时,管状套可具有都延伸整个长度的内部衬垫和加强线圈,以及串联的外管至少两个部分,其具有产生该套的不同刚度的不同硬度。
在此公开的另一个方面是医学插管器和心脏瓣膜递送导管组合,其包括具有足够直径的远端球囊的递送导管,以膨胀其上蜷曲的心脏瓣膜。接收穿过其中的递送导管的插管器具有从近端外壳上向远端延伸的细长管状套。近端外壳包含至少一个插管器阀,用于在递送导管近端长度周围进行流体密封。该套进一步包括近端段和远端部分,该近端段具有第一刚度,其延伸套长度的至少一半的长度L,该远端部分具有不同于第一刚度的第二刚度和长度l。管状加装器(loader)限定了接收递送导管远端部分的通孔,管状加装器具有用于将结合结构啮合在插管器外壳近端上的结构和远端鼻,该远端鼻延伸穿过并打开插管器阀,并促使递送导管的球囊通过其中。
本申请还进一步的特征为医学插管器和心脏瓣膜递送导管组合,其包括具有足够直径的远端球囊的递送导管以膨胀其上蜷曲的心脏瓣膜。该导管包括在球囊近端处的标记带,和相对于球囊纵向移动并具有远端标记带的管状瓣膜推进器。具有从近端外壳上向远端延伸的细长管状套的插管器包含至少一个插管器阀,用于在递送导管近端长度周围进行流体密封。该插管器套具有用于递送导管的通道的通孔和在其末梢周围的标记点阵列,以便将末梢与球囊和推进器的标记带区别开。
根据还进一步的方面,医学插管器和心脏瓣膜递送导管组合包括递送导管、插管器和位于其间的管状加装器。递送导管具有足够直径的远端球囊以膨胀其上蜷曲的心脏瓣膜。插管器具有从近端外壳上向远端延伸的细长管状套,该近端外壳包含至少一个插管器阀,用于在递送导管近端长度周围进行流体密封。最后,管状加装器包括接收递送导管远端部分的通孔、用于将接合结构啮合在插管器外壳近端上的结构和延伸穿过并打开插管器阀的远端鼻,促使递送导管的球囊通过其中。加装器也具有带有用于在插管器套周围进行流体密封的密封件的近端外壳,和用于从加装器内吸出空气的单手使用排放口(single-handed vent)。
本申请的心脏瓣膜递送导管包括导管管子,该导管管子在其上具有足够直径的远端球囊以便完全从其内膨胀蜷曲的心脏瓣膜。该球囊位于由偏转拉线驱动的导管管子的可偏转部分的末端上。递送导管进一步包括在导管管子上滑动并相对于球囊纵向移动的管状瓣膜推进器。递送导管也具有近端控制手柄,其上同时安装有用于偏转导管管子的可偏转部分的偏转驱动器和用于移动瓣膜推进器的推进器驱动器。优选地,递送导管包括从控制手柄内延伸的多个同心管,和至少一个在手柄内的用于在管之一周围进行密封而不阻止其移动的被动式密封件(passive seal)。
本申请的另一个益处是医学插管器和心脏瓣膜递送导管组合,其包括具有导管管子的递送导管,该导管管子在其上具有足够直径的远端球囊以便完全从其内膨胀蜷曲的心脏瓣膜。插管器具有从近端外壳上向远端延伸的细长管状套,该近端外壳包含至少一个插管器阀,用于在递送导管近端长度周围进行流体密封。管状加装器限定了接收递送导管的远端部分的通孔,并包括用于将接合结构啮合在插管器外壳近端上的结构,和延伸穿过并打开插管器阀并促使递送导管的球囊通过其中的远端鼻。加装器具有带有用于在插管器套周围进行流体密封的加装器密封件的近端外壳,和用于从加装器内吸出空气的单手使用排放口。
在此公开的心脏瓣膜递送导管和心脏瓣膜组合以具有蜷曲构造以及近端和远端的可膨胀的人造心脏瓣膜为特征。递送导管包括导管管子,该导管管子在其上具有足够直径的远端球囊以便完全从其内膨胀蜷曲的心脏瓣膜。该球囊具有大于心脏瓣膜长度的长度,以便具有近端和远端的暴露部分,并且球囊以仅留下纵向折叠线的方式进行折叠,以便在超声心动描记术(echocardiography)下与心脏瓣膜末端形成对比。
本申请的心脏瓣膜递送导管是具有导管管子的递送导管,该导管管子在其上具有足够直径的远端球囊以便完全从其内膨胀蜷曲的心脏瓣膜,该球囊被放置在由偏转拉线驱动的偏转管子的末端上,该可偏转部分包括编织结构和偏转线,该偏转线沿其长度延伸直至偏转线附接的远端线圈,该可偏转部分具有不大于8French的尺寸。
在以下的说明书和权利要求中提出本发明性质和优点的进一步理解,特别是当与附图结合考虑时,在附图中相同的部分具有相同的参考数字。
附图说明
本发明的特征和优点将被理解,因为本发明的特征和优点通过参考说明书、权利要求和附图变得更好理解,其中:
图1为患者的示意性正视图,其显示了向心脏左心室尖提供入口的肋间切口的位置;
图2A-2B为通过患者的心脏左侧的横截面视图,其显示了在植入根据本发明的人造心脏瓣膜前扩张钙化主动脉环的过程;
图3A-3E为通过患者的心脏左侧的横截面视图,其显示了在用于植入根据本发明的人造心脏瓣膜的过程中的数个步骤;
图4为用于本发明的从口进入心脏瓣膜植入过程中的插管器/扩张器组合的分解透视图;
图4A为图4插管器/扩张器组合的组装视图;
图5A和5B为图4插管器的分解透视图和正视图;
图6A为图4插管器的平面图;
图6B为沿图6A的线6B-6B得到的插管器的纵向截面视图;
图6C和6D为图6B插管器的可变柔性套的放大视图部分;
图7为用于植入在此公开的人造心脏瓣膜的示例性球囊导管/加装器组件的透视图;
图7A为在图4-6的插管器和图7的球囊导管之间提供分界面的加装器的分解透视图;
图8为图7球囊导管的分解正视图;
图9为图7球囊导管的近端控制手柄的纵向截面视图;
图10为图9近端控制手柄的分解视图;
图11为图7球囊导管的远端偏转段的放大截面视图,其也显示了在保护套内处于收缩状态的远端球囊;
图12为处于其膨胀状态的图7球囊导管的远端球囊的放大截面视图;
图13为与球囊上蜷曲的心脏瓣膜连接前,球囊导管和插管器(部分)组合的分解视图;
图14A为在通过插管器插入球囊导管后,球囊导管和插管器(部分)组合的组装视图;
图14B-14E为类似于图14A的视图,其显示了在发生瓣膜植入过程中的一系列步骤中原位使用在此公开的心脏瓣膜递送系统;
图15为示例性球囊导管的远端的纵向截面视图,其显示了在植入期间在球囊上蜷曲的人造心脏瓣膜,该球囊以提高瓣膜可视化的方式进行折叠;
图16为图15的折叠球囊的径向截面;和
图17为图16的球囊的径向截面,其说明了优选的折叠技术。优选实施方式的详细描述
心脏是略微圆锥形的中空肌肉器官;其位于肺之间的中纵膈中并被封闭在心包中。心脏偏斜地位于胸骨体和软肋骨的邻近部分后面的胸部中,并且与右半胸腔相比,更多地伸入左半胸腔,所以大约三分之一位于中央面右边,三分之二位于中央面左边。心脏通过隔被再分为右半面和左半面,并且结(constriction)将器官的每一半再分成两个腔,上腔被称为心房,下腔被称为心室。心脏因此由四个腔组成;右心房、左心房、右心室和左心室。
如图1所见,左心室尖LVA指向下、向前并朝向左边(从患者的角度来看)。该尖通常位于第五左肋间空间(或在第四和第五之间)后面,距离胸骨中线8至9cm,并且在左乳头下方大约4cm,距离左乳头中间侧2mm。可因此通过如虚线所示的肋间切口20得到至左心室的入口,其位于第五左肋间空间上方。这样的方法通常被称为“微型胸廓切开术”,并且有助于利用一个或多个短管或“口”在心脏上进行外科手术——因此,该手术经常被称为“从口进入”过程。
在本发明的优选实施方式中,外科医生在通常被钙化的现有天然小叶上植入人造心脏瓣膜。存在用于去除钙化小叶的过程和设备,但与之相关的风险——包括钙化物质释放进入血流,不是无关紧要的。因此,在天然小叶上直接安装人造心脏瓣膜并包含天然小叶的心脏瓣膜替换过程是优选的。
本领域技术人员将意识到可能有必要在主动脉瓣内展开人造瓣膜前预扩张狭窄主动脉瓣的小叶和环。图2A和2B为瓣膜成形术过程的两张照片,该瓣膜成形术过程可首先被实施,以朝窦和升主动脉向外挤压天然主动脉心脏瓣膜小叶。如以上所提及的,天然主动脉瓣小叶可被基本上钙化,并且瓣膜成形术可能必须破裂和以其他方式强行分开变硬的组织。预扩张增加了通过主动脉瓣的流动面积并在小叶上产生大小足够接收人造瓣膜的开口。优选地,利用可膨胀的构件实现预扩张,例如扩张球囊导管。瓣膜环预扩张的例子参见2005年6月21日授予Cribier的美国专利6,908,481号,并且在此通过引用明确并入。
图2A说明了通过左心室LV上预形成的顶部小孔(apicalpuncture)32引入导丝30。导丝30的末梢34延伸通过天然主动脉瓣AV并进入升主动脉AA。末梢34可进一步在主动脉弓上延伸,如图2B所见,但最小延伸是跨过主动脉瓣AV。
图2B说明了通过顶部小孔32插入LV的插管器套38,其中球囊导管40具有经过导丝30并穿过套的远端上的扩张球囊42。如已知的,在插入套38前,具有渐细尖端的扩张器(未示出)可首先在导丝上插入,以扩大顶部小孔32。在这点上应该注意,外科医生在围绕小孔32的左心室尖的组织中安装一个或多个抽合式缝合线44。这些缝合线44在形成最初的小孔前被预植入。在优选实施方式中,外科医生通常以一个方向以第一圆放置抽合式缝合线的第一线,并且随后通常以与第一圆同心的圆但以相反的方向放置抽合式缝合线的第二线。结果是限定外围——小孔在该外围内形成——两个同心圆的单独抽合式缝合线44。因此,可拉动抽合式缝合线44,以便在任何穿过该小孔的物体周围抓牢(cinch)心室组织。特别地,抽合式缝合线44在导丝30和插管器套38周围都被收紧。以相反方向安装抽合式缝合线44的单独线有助于防止撕裂心室组织,并对任何穿过小孔的细长物体的周围都提供更均一的挤压。
如图2B所示,扩张球囊42径向向外膨胀,接触天然主动脉瓣小叶。利用关于特定主动脉瓣的大小的信息,选择球囊42以便其向外膨胀并象征性地朝周围的主动脉壁挤压主动脉瓣小叶。存在各种用于估计特定患者主动脉瓣大小的方法,包括超声,在此将不描述。只说在图2B所见的瓣膜成形术过程之后,天然主动脉瓣小叶被朝向主动脉壁向外挤压,并产生基本上圆形的孔。关于预扩张和瓣膜替换的其他细节可在Cribier的申请人的美国专利6,908,481号中找到,并且在此通过引用明确并入。
现在参考图3A-3E,利用切顶方法展开和植入本发明人造心脏瓣膜的优选方法现在将更详细地描述。在此公开的设备和方法特别适于替换狭窄主动脉瓣,因此见于图2A-2B的预扩张过程通常先于瓣膜植入进行,以便使环和小叶的轮廓平滑。然而,应该注意,可进行在此描述的过程而不需要瓣膜预扩张。
此外,可作为第一次瓣膜植入或为了弥补先前植入,实施本过程。占相对大比例的人造心脏瓣膜接受者是年长的,通常大于60岁。随着时间的推移,已知人造心脏瓣膜显示降低的性能,并且甚至失效。对70多岁和甚至80多岁的人进行再次手术是成问题的。然而,例如在此公开的从口进入过程排除了开心手术和可能的心肺旁路手术,并且因此对于老年患者是更期望的。因此,本发明考虑了在现有人造瓣膜植入物上切顶植入人造心脏瓣膜。在这样的情况下,通常不需要预扩张步骤,尽管其是可想到的。
在讨论过程本身之前,应该注意,以下参考图4-13将更详细地描述本发明优选的递送系统。在解释最终在主动脉环中植入瓣膜所采取的步骤后,本递送系统的运行可更容易被理解。
在此描述的人造心脏瓣膜植入过程可结合心肺旁路手术实施,或不采用旁路手术在所谓的非体外循环过程中进行。旁路手术的必要性取决于很多因素,包括患者的年龄、对这样过程的敏感性和天然小叶的存活性。理想地,植入过程以非体外循环方式进行。
外科医生或心脏病专家首先利用物理定径机或用超声心动描记术确定主动脉瓣的大小。医生或手术室职员随后在球囊导管54的球囊52上蜷曲可膨胀的人造瓣膜50(目前描述的某些元件可见图3A-3E的过程图,而其他的可见图4-13的系统图)。外科医生通过在扩张器74(有时也称为插管器)的帮助下已经插入通过左心室尖小孔32的插管器套70,在导丝60(可能是用于预扩张过程的相同的导丝30)上推进球囊导管54。
用于预扩张过程的同一抽合式缝合线44可也被用于密封插管器套70周围的心室组织。在不存在预扩张过程的情况下,抽合式缝合线44在形成最初的小孔前被预植入。与之前一样,外科医生通常以一个方向以第一圆放置抽合式缝合线的第一线,并且随后通常以与第一圆同心的圆但以相反的方向放置抽合式缝合线的第二线。结果是限定外围——小孔在该外围内形成——的并且在插管器套70周围密封的两个同心圆的单独抽合式缝合线44。
此外,膨胀小孔32的内直径并支撑在导丝60上前进的扩张器74可在插管器套70前或与插管器套70一起插入。优选的扩张器直径位于12和22French之间的范围内。插管器套70包括将在以下描述的插管器的远端。不大于24French、期望为22或24Fr的插管器套直径是优选的。
图3A显示了插管器套70,其通过小孔32并在穿过钙化主动脉瓣AV向上延伸的导丝60上进入左心室。外科医生恰好在主动脉瓣AV的流入侧放置插管器套70的末梢72,如图3A中所见。在这点上,本领域技术人员应当理解,插管器套70相对于主动脉瓣AV以及系统其他元件位置的位置,利用不透射线标记和荧光检查进行监测,或利用其它成像系统例如经食道回声、经胸回声、血管内超声成像(IVUS)或不透射线的可注射染料进行监测。用于示例性系统的这样标记的具体组合将在以下进行描述。
图3B显示了球囊导管54在导丝60上并穿过插管器套70前进。最终,如图3C所见,人造心脏瓣膜50位于主动脉环上并在天然主动脉小叶之间。图3C也说明了插管器套70从图3B中其更向前的位置缩回,以允许球囊扩张/瓣膜膨胀。可在插管器套70的末梢72上提供不透射线标记,以更加准确地确定其相对于瓣膜50和球囊52的位置。
此外,人造心脏瓣膜50的精确定位可通过在其远端和近端或在中间例如在中点上定位不透射线标记而实现。期望地,外科医生能通过驱动球囊导管54内的操纵或偏转机构调整瓣膜50的位置,如将在以下所描述的。此外,通过从其近端拧动球囊导管54并在荧光检查下观察瓣膜(或球囊导管)上的具体标记,能相对于天然主动脉瓣的尖和连合,调整瓣膜50的转动朝向。显示了朝升主动脉窦之一开孔的冠状动脉口80中的一个,并且本领域技术人员将理解,人造瓣膜50不阻塞两个冠状动脉口是重要的。也应当注意,尽管主动脉瓣AV的天然小叶在图3A中显示为合紧,并且通过图3B和3C中的球囊导管54被柔韧地移动,但它们实际上从预扩张过程可进一步朝主动脉环向外挤压。
图3C显示了处于在球囊52周围蜷曲的其收缩或未膨胀状态下的人造心脏瓣膜50。当外科医生满意瓣膜50合适的定位和转动朝向时,膨胀球囊52,如图3D所见。天然主动脉瓣AV合适的大小测量使外科医生能够选择最佳大小的瓣膜50,以便其向外膨胀至与主动脉环良好接触。术语“良好的接触”意味足够接触,以确保人造心脏瓣膜50在植入后不迁移。然而,瓣膜的过度膨胀可损害周围组织或干扰邻近瓣膜的性能。
很多设备都可利用,以协助将人造瓣膜50固定到主动脉环中,例如倒钩(barb)和类似物。与本发明一起使用的人造心脏瓣膜50的优选构造在2009年6月8日提交的共同未决的Hariton的美国专利申请序列号12/480,603中公开,该公开在此通过引用明确地并入。另一个瓣膜在2004年6月30日提交的Spenser的美国专利7,276,078号中公开,该公开也在此通过引用明确地并入。当然,瓣膜50可采取各种不同的形式,但通常包括支撑瓣膜结构的可膨胀的支架部分。该支架部分具有足够的径向强度,以便在治疗位点支撑瓣膜并对抗狭窄瓣膜小叶的反冲(recoil)。关于优选球囊可膨胀的瓣膜实施方式的其他细节可在Spenser的两个美国专利6,730,118号和6,893,460号中发现,两者在此通过引用明确地并入。优选人造心脏瓣膜50在其外表面上包括足够的不规则,以便其可被固定在主动脉环中,而不需要使用倒钩或其他刺穿组织的结构。
一旦瓣膜50被合适地植入,如图3D所见,外科医生使球囊52收缩,并在导丝60上收回包括球囊导管54的整个递送系统。插管器套70随后被收回,随后是导丝60。最终,先前描述的抽合式缝合线44被收紧并系上以闭合小孔32,如图3E所见。
意识到本发明的心脏瓣膜递送系统特别适于顺行(antegrade)、左心室尖、“切顶”进路是重要的。更具体地,微型胸廓切开术进路要求相对短的器具。因此,期望地,延伸入体内的插管器套70的部分不大于大约8英寸(20cm)长,并且期望地可延伸入插管器套70的球囊导管54的长度即“工作长度”不大于大约24英寸(61cm)。进一步关于球囊导管54和插管器套70的相对短长度的细节将在以下被提供。在此描述的较短长度的人造心脏瓣膜递送系统也很适于其他解剖进路,包括通过颈动脉或锁骨下动脉。短长度的系统是期望的,因为相对于较长系统,其提高了远端的可控制性和可操作性,这帮助提高瓣膜定位的准确性并减少瓣膜定位的时间。
本发明的递送系统基本上包括插管器100、球囊导管54以及附带的连接器(attendant coupler)和操作结构,包括如图7所见的在插管器和球囊导管之间的加装器140。插管器100在图4-6中说明,而球囊导管54和加装器140在图7-12中示出。应该注意,该递送系统类似于用于经皮植入人造主动脉瓣的另一个系统,这在Taylor的2005年6月13日提交的共同未决的美国专利公布2007-0005131号中公开,并且在此通过引用明确地并入。本系统在若干方面中有所不同,这使其更适合切顶、从口进入或直接进入进路,尽管某些特征是共同的。
如图4和4A所见,插管器100包括与包含一系列阀的插管器外壳102相连接的前述的远端套70。图5A和5B的分解视图显示了从插管器外壳102上拆卸下来的端盖104。端盖104包括凸缘管接头105,用于与加装器140相结合,如将在以下进行解释的。端盖104螺纹连接或以其他方式附接到外壳102上并保持在其中,从近端至远端串联十字头阀(cross-slit valve)106、圆盘阀108、垫片110和鸭嘴阀112。当没有器具穿过插管器100时和当若干不同大小的器具穿过其中时,这三个阀用于提供密封。例如,如先前所示,所述阀在导丝60和球囊导管54二者周围密封。插管器套70延伸进入身体血管,插管器外壳102位于身体血管之外。在优选实施方式中,插管器套70具备外部亲水涂层并具有大约20-24cm之间的长度,以便其可延伸通过入口切口20(见图1),进入左心室并到达主动脉环。
如图5和5A最佳所见,插管器套70经由密封延伸122附接到外壳102上,密封延伸122与从外壳102上延伸的远端管接头124相接合。优选地,在这两个接合部分之间使用粘合剂。带螺纹的螺母126依附在套70上并连接到提供在正好接近管接头124的外壳102上的螺纹128。以这种方式,不同的部件可被单独制造(通常为模塑或挤压)并在组装期间容易地连接到一起。在连接螺母126前,粘合剂可被应用到螺纹128上,以便得到更加牢固的最终组件。
侧口管子130以一个角度延伸远离插管器外壳102并终止于三通旋阀132。这允许即使设备例如球囊导管54存在于其中,用户也通过插管器100的腔输注药物或其他流体。
图6A-6D显示了插管器100更多的细节,包括套70远端部分上的一系列深度标记133。标记133指示以毫米为单位的距离末梢72的距离,以便末梢延伸进入左心室尖的深度可被容易看到。
图6B和6C说明了有利的构造,其中与沿近端部分相比,套70沿远端部分具有更大的柔韧性。具体地,套70包括远端部分134,其具有比近端部分135更柔性的长度l,其中套70的自由长度为L(从带螺纹的螺母126处延伸)。图6C显示了套70的内部构造,其包括内管状衬垫136、加强线圈137、远端外管138和近端外管139。衬垫136和线圈137延伸套70的自由长度L,而外管138,139串联邻接。期望地,近端外管139的刚度大于远端外管138的刚度,以提供不同的柔韧性。尽管示出每个具有恒定刚度的两个分离的部分,但可以在多于两个部分中并且更加逐步地改变柔韧性,而具有相似的结果。
通过提供更柔性的远端部分134,调节插管器套70周围(例如在图3D的位置上)的心脏肌肉的移动,对心脏组织产生更少创伤。即,优选过程针对跳动的心脏,其中左心室连续收缩和放松,这产生显著量的组织/插管器移动。允许插管器远端弯曲或松弛,有助于降低对心脏壁的损害。此外,为了进入更好的植入位点,外科医生经常操纵导管或插管器,其对于更坚硬的套可引起对心脏壁的创伤。同时,该较坚硬的近端部分135确保插管器100以相对径直的线伸出手术区,松弛度最小,这是外科医生需要的。有时可在切口点上使用稳定器,其减少了心脏壁移动,但套的松弛远端仍然提供了益处。
衬垫136提供了光滑的内表面,带有心脏瓣膜的球囊导管可无障碍地穿过该内表面,并且线圈137向管状结构提供了周向强度(hoopstrength),以阻止扭结。可利用一些管形成技术,例如挤压,制造套70。
在一个实施方式中,套70的自由长度L处于大约20-24cm之间,同时远端部分134具有在大约4cm和自由长度L一半之间的长度l。更优选地,远端部分134具有大约6-9cm之间的长度l,并且最优选地,大约9cm。长度l应该足够允许套70的松弛部分延伸进入心脏壁至少4cm。
在示例性实施方式中,为了更好的合并(melding),内部衬垫136和外管138、139以相同的材料制成,而线圈137是金属的。一个具体的组合为由以商标名称销售的尼龙嵌段共聚物制成的衬垫136和外管138、139,而线圈137是不锈钢。商业的PEBAX聚合物由被聚酰胺嵌段分开的聚醚嵌段组成。聚醚嵌段可基于聚乙二醇、聚丙二醇或聚四亚甲基醚二醇。聚酰胺通常基于尼龙-11,但也可基于尼龙-6,6的尼龙6或甚至共聚物例如尼龙-6/尼龙-11。聚合物用硬度计测量的硬度处于从肖氏A 60至肖氏D72的范围内,并且近端外管139与远端外管138相比具有更大的硬度。PEBAX组合物和它们各自的物理性质的选择在网站www.pebax.com中,特别是在链接“MedicalApplications”下有所提供。是法国巴黎Arkema Inc.的注册商标,其美国公司办公室位于宾夕法尼亚州的费城。
图6D也显示了用于插管器套70的末梢72的有利可视化系统。末梢72处的圆形标记点阵列73在荧光检查下可见,并且与提供在球囊导管54上的标记带形成明显对照,如以下所解释的。
图7说明了球囊导管54的透视图,其包括以路厄接头142开始于近端和以软末梢144终止于远端的相互关联的部件的组件。球囊导管54——也在图8-12的平面、截面和分解视图中示出,包括具有路厄接头142、球囊扩张连接器152、偏转驱动器154和推进器驱动器156的控制手柄150。推进器体158从手柄150绕球囊偏转管160延伸,球囊偏转管160具有仅位于软末梢144近端的可膨胀球囊52。图7说明了覆盖球囊52的球囊套161,其在运输期间保护球囊并在使用系统前被去除。细长固定保护套筒162也从手柄150在大部分推进器体158上延伸,并沿其长度的大部分形成球囊导管54的外表面。在图7A的透视图中示出的加装器140将在以下进行更详细的描述,并提供了球囊导管54和上述插管器100之间的连接。
如所提及的,本申请公开了用于插管器套70的末梢72的有利可视化系统。具体地,将在球囊52的近端并且也在推进器体158的远端上提供至少一个标记带。可因此容易看到推进器体158远端和球囊52近端的轴向接近,以便于它们的啮合。另外,插管器套70的末梢72处的圆形标记点阵列73与球囊导管54和推进器体158上的标记带形成明显对照,并帮助外科医生在瓣膜定位和球囊膨胀时确保插管器已经缩回足够远。
在详细描述示例性球囊导管54之前,将解释其经由加装器140与插管器100的相互作用。如在图7A所见,加装器140具有大体管状体172和轻微向外渐缩的远端鼻174,远端鼻174安装入插管器100中,并具体通过图6B示出的一系列阀106、110、112。加装器体172包括一对附接的悬臂式指176,其纵向且内部面向按扣脊(snap ridge)延伸,用于将加装器140固定至插管器100的近端盖104上的管接头。加装器140便于将球囊导管54引入插管器100。如以上所描述的,插管器外壳102包含一系列阀106、110、112,其在一起提供有效的流体密封,以在存在或不存在不同大小的医学用具的情况下防止血液穿过插管器100流出。加装器140的远端鼻174延伸通过插管器外壳102并通过这些阀106、110、112(见图14A),以保持它们打开并提供与插管器套70腔大小匹配的光滑内腔。以这种方式,具有在球囊52周围蜷曲的人造瓣膜50的球囊导管54的略微不规则的轮廓可平滑地穿入插管器套70。
在图7A中分解所见的位于近端外壳178内的加装器密封件包括一对环形垫圈180和弹性排放构件182。如图7所见,保护套筒162穿过加装器140,并且加装器密封件阻止了流体在套筒周围溢出。排放构件182包括通过近端外壳178侧面中的孔伸出的一对侧面按钮184。一个或两个按钮184的向内压下引起排放构件182变形,这又向大气打开加装器体172内的远端空间。可因此容易地用一只手排出加装器体172内血液中夹带的任何空气。单手吸出更加方便并且也帮助避免因旋松至排放口的阀盖而产生的心脏瓣膜的不慎未对准,这是传统布置的双手操作的问题。此外,用被动式加装器密封件消除了收紧弹性密封件的先前带螺纹盖布置意味着保护套筒162(和递送导管54)的移动决不被加装器阀阻止。以这种方式,将导管54的移动与加装器140和附接的插管器100分开。
在如图12中所见的球囊膨胀前,加装器140连接到球囊导管54的远端范围上,如图7中所见的。远端鼻174插入插管器外壳102,并且悬臂式加装器指176与端盖104的凸缘管接头相接合(图14A)。球囊导管54因此与插管器100相连接。向远端滑动整个球囊导管54允许其远端的不规则轮廓安全地穿过阀106、110、112并进入插管器套70。在瓣膜植入过程期间,加装器140保持与插管器100相连接,并且可根据需要驱动排放构件182,以确保没有空气保留在系统中。
球囊导管54的各部件现在将相对于图8-12进行描述。导管54包括近端控制手柄54和向远端延伸至软末梢144的多个同心管。在示例性实施方式中,逐渐更小尺寸的五个同心管连接到手柄150上或延伸进入手柄150,如图10B中所见。手柄150包括具有多个内壁和腔的两个模塑的半部分(halve),以包含各部件。
手柄150包括一些控制部件并以截面图在图9中以及以分解图在图10A和10B中示出。具体地,触发器形式的偏转驱动器154控制球囊偏转管160末梢的偏转,滑动器形式的推进器驱动器156控制推进器体158的纵向移动,并且旋阀190的操作允许输注流体,以冲过插管器套70和推进器体158之间的空间。此外,处于手柄150近端处的Y型口192提供了通向路厄接头142的纵向通道和通向球囊扩张连接器152的成角度通道。具有通孔的内管194(最小的)从路厄接头142延伸球囊导管54的长度,穿过远端软末梢144(见图12)。内管194为导丝的通过提供了通路,例如图3D中60处所示。路厄接头142也可提供用于注射放射照相对比剂通过内管194的进入点,在人造瓣膜被植入后,其有助于检查瓣周泄漏。
仍然参考图8-10,并且特别是图9,球囊扩张管196(第二小的)围绕内管194,以远端方向从Y型口192延伸并终止于球囊52内。如图9中所见,Y型口192包括阶梯式纵向孔,所述孔具有密封地接收球囊扩张管196的较大远端部分和密封地接收内管194的较小中间部分。通向球囊扩张连接器152的成角度通道与对球囊扩张管196的腔开放的内管194外部的空间流体连通。利用该构造,注入球囊扩张连接器152的流体进入并行进球囊扩张管196的长度,直到它在球囊52内从其开放远端198离开(如图12所见)。可沿球囊52的长度在球囊扩张管196中提供额外的流体流出口(未示出),用于均匀扩张,并且特别是人造心脏瓣膜50的近端和远端处的出口有益于帮助瓣膜的两端以相同的速率膨胀。
球囊扩张管196延伸通过球囊偏转管160(第三小的)的腔,球囊偏转管160具有由在手柄150的腔内安装的轴环200固定的近端。球囊偏转管160具有特定的构造,该构造能够实现沿其长度弯曲而不扭结,并且球囊偏转管160具有可偏转的末梢。更具体地,期望地,球囊偏转管160包括沿其长度的编织管以防止扭结、在其末梢处用于偏转的线圈结构、和从近端延伸到线圈的偏转线202。
偏转线202也包括在其近端上安装的插头204,其被在手柄150内纵向滑动的轨道206作用。具体地,偏转线202穿过轨道206上指状物208的孔,该孔小于插头204。期望地,插头204为圆柱形的并可被限制在保持在手柄150的腔内的小引导套筒210内。轨道206形成触发器组件的一部分并与触发器154一起移动。从其在图8和9中的位置向左拉动触发器154将向左移动插头204,也向左或向近端方向拉动偏转线202。偏转线202又附接到球囊偏转管160末梢212处线圈的一侧,并且拉动所述线因此使该末梢偏转,如图14D和14E中所见。当然,通过绕其轴线旋转整个球囊导管54,可以以任何方向操纵偏转段212。该线圈同时提供柔韧性和弹性,以便放松偏转线202的紧张状态允许偏转段212回到平直方位。
偏转管160的构造能够实现从先前设计减少大小,最终使瓣膜50和球囊52的大小减少得以实现。在一个实施方式中,偏转管160具有不大于8French的尺寸。编织的近端部分提供了柔韧性和断裂强度(column strength),而远端线圈能够实现仅在远端处发生偏转。具有线圈结构的末梢212期望具有大约4cm的长度。该构造也便于制造,因为具有附接偏转线202的编织近端部分和线圈容易利用焊接或类似方法进行结合。
第二大的管为推进器体158,直到其远端上向外张开的套筒220其是管状的(见图8和11)。推进器体158的近端附加到与滑动器盖224的内部带螺纹孔相连接的带螺纹套筒222上,如图9和10B所见。滑动器盖224的孔内的一个或多个被动式O形环密封件226允许滑动器构件在球囊偏转管160上的相对移动,同时对其间的血液渗漏密封。期望地,两个O形环226将环形聚合物(例如,尼龙)垫圈228夹在中间,以帮助均衡在每个O形环上的力,并因此提高球囊偏转管160周围流体密封的质量。沿手柄150中相应的纵向狭槽平移滑动器156和所附接的滑动器盖224因此相对手柄和球囊偏转管160移动推进器体158。先前的设备包括单独手柄,并且密封件将位于要求收紧的带螺纹的盖内。O形环密封件的被动性质消除了双手收紧操作,并且也避免了一旦被放置,因球囊偏转管160的不慎移动造成的心脏瓣膜50的任何未对准。
此外,手柄150的设计便于单手操作球囊导管54的两个主要移动——末梢的偏转和推进器体58的线性移动。手柄150优选地包括在其下侧的人体工程学肋部230,如图8所见,其与滑动器156上的肋部相连接,帮助沿导管移动推进器体158。
推进器体158在球囊偏转管160上以及固定保护套筒162(最大的管)的内部滑动。如图9所见,套筒162附加到旋阀190外壳的阶梯式孔内,旋阀190又附接到手柄的远端上。保持在旋阀外壳内(或在外壳和手柄150之间)的O形环密封件232接触和密封移动的推进器体158的外部,并阻止流体从推进器体158和固定保护套筒162之间的同心空间中渗漏。可因此通过旋阀190输注盐水或其他这样的流体,以向下行进并冲过推进器体158和固定保护套筒162之间的同心空间。
图11为球囊导管54远端的正视图,其显示了收缩的球囊52和与推进器套筒220间隔的其近端,而图12显示了具有扩张的球囊52的球囊导管54的远端。
内管194穿过球囊52并终止于前述软末梢144覆盖的远端。软末梢144促进引入球囊导管54并减少对周围组织的创伤。这在本发明的优选过程中特别重要,其中导管进入左心室尖并通过主动脉瓣行进到升主动脉中。如图3D所见,导管的末梢可延伸足够远,以进入主动脉弓,并且软末梢144因此阻止了周围血管组织的破裂或其他磨损。图13也说明了内管194和软末梢144的开放远端,通过该开放远端,可首先穿过导丝62,并且随后可在植入后注射放射照相对比剂以验证瓣膜充分性。
球囊52包括第一圆锥部分240、主圆柱形部分242和第二圆锥部分244。为了均匀的圆柱形膨胀,人造心脏瓣膜50期望地在主圆柱形部分242周围蜷曲,例如在图12的虚影中示出的。球囊52可由尼龙制成,并评定为6-8atm的爆裂压力。在优选实施方式中,膨胀的球囊直径在大约20至28mm的范围内,具体的大小取决于被植入的心脏瓣膜50的大小。
图15为示例性球囊导管54远端的纵向截面视图,其显示了在球囊52上蜷曲的人造心脏瓣膜50。心脏瓣膜50具有比球囊52短的长度,留下其近端和远端暴露部分。
球囊52以在植入期间提高瓣膜的可视化的方式进行折叠。具体地,某些传统折叠技术导致球囊52起皱。例如,折叠导管球囊的常见方式为首先形成三折叠,随后绕球囊导管轴线卷起三折叠的叶片。类似这样的折叠技术,即使操作很小心,经常也会留下褶皱或褶痕。这样的不规则性显示在超声心动描记上,会干扰瓣膜50的近端和远端相对于植入位点的精确位置。在另一方面上,本发明的球囊52以即使不能消除也降低显示在超声心动描记上的不规则性的方式进行折叠,因此提高了将心脏瓣膜50适当地放置在主动脉环处的能力。
图16为图15的折叠球囊的径向部分,并显示了以绕内管194、196逆时针方式折叠的球囊52的四个叶片250,尽管叶片被卷的方向当然并不重要。图17说明了折叠前的叶片250。叶片250沿球囊52纵向延伸并包括球囊52的均匀圆周跨度。通过仔细选择每个叶片250的径向尺寸,对于该尺寸的球囊,使所得到的图16中的卷起结构最小化,并且确保均匀的圆周卷起率产生卷起结构中的纵向线。纵向折叠线在荧光检查下与瓣膜50的径向末端形成对照,因此确保清晰看见瓣膜。此外,纵向折叠线与球囊和推进器上的标记带形成对照,如以上所解释的。在球囊中可具有预先形成的四个或更多、可能6-8个折叠或褶,其也便于收缩和穿过阀和插管器去除。
在使用中,本发明提供了用于在主动脉环中植入人造心脏瓣膜50的新型和有效的方式。以上已经相对于图1-3描述了该过程的步骤,至少直到最终的植入步骤。现在将参考图13和14A-14E提供在实施整个过程中的示例性球囊导管54和插管器100的有利使用的描述,其是没有瓣膜50的系统的原位视图。
首先,如以上所提及的,医生确定患者的环的大小。这可通过在左心室尖中产生切口20和小孔32(图1和2A),并向主动脉环插入定径器,在身体上进行。然而,小孔32可能不够大,不能穿过传统定径机,可利用可选技术例如超声心动描记术或其他这样的成像系统。
随后,选择球囊导管54、插管器100、加装器140和人造心脏瓣膜50并通过将它们从任何包装移出并且如果需要漂洗或消毒而准备使用。可实施如以上相对于图2A-2B所描述的预扩张步骤,以扩大或破裂主动脉环中存在的钙化。
可以以很多方式完成在球囊52上蜷曲人造心脏瓣膜50的过程,并且在市场上存在用于在球囊上蜷曲球囊-膨胀支架的合适设备。在优选实施方式中,利用具有像照相机的孔径光圈那样工作的压缩机构的设备。在这样的设备中,在人造心脏瓣膜50外围附近的多个连续段单独但一致地关闭,以便在心脏瓣膜上施加均一向内的压力。该设备通常手动操作。
随后,前述推进器体158和张开的套筒220在球囊52的近端上向远端推进,例如如图13中所见。加装器140随后被固定在球囊导管54的远端上,包括球囊52和人造瓣膜(未示出)的组件。
这时,或在球囊导管准备的同时,插管器100位于如图3A所见的左心室内。此外,抽合式缝合线44维持插管器套70周围的流体紧密密封。在整个过程期间,心脏可继续跳动。医生将加装器140的远端鼻174插入插管器100的近端盖104并将加装器降至最低点,以便悬臂式指176啮合插管器的凸缘的管接头105,如图14A所见。这时,球囊导管54准备好引入体内。
推进器体158和推进器套筒220,以及固定保护套筒162,促进偏转段212和所附接的其上具有蜷曲的瓣膜50的球囊52前进通过插管器套70和其阀106、110、112。特别地,张开的推进器套筒220在通过插管器套70期间围绕偏转段212和球囊52的近端部分。推进器套筒220固定蜷曲的瓣膜,防止相对于球囊52移动。最终,推进器体158相对于球囊偏转管160的近端缩回释放偏转段212,以成角度的移动,并且释放球囊52,以膨胀。
医生随后相对于加装器140和插管器100向远端推进球囊导管54进入例如图14B中示出的位置。在这种状态下,例如利用超声心动描记术,具有瓣膜的球囊52可被推进至其最终的植入位置。
医生随后通过简单地滑回手柄150上的推进器驱动器156,从偏转段212和球囊52的近端部分上缩回推进器套筒220,如图14C所见。推进器体158周围的固定保护套筒162起到将推进器移动与插管器的阀分开的作用,因此降低了推进器上的摩擦。同样地,滑回推进器驱动器156,同时抓紧手柄150的单手操作大大地降低了瓣膜位置未对准的机会。
医生可进一步推进球囊52并将球囊52转向一定角度,直到其到达图3C中示出的位置。利用放射照相标记和荧光检查,整个操作被可视化,并且通过与偏转段212的角变化相联系的导管54的轴向移动和旋转,完成了球囊52和安装在其上的人造瓣膜50的精确定位,如图14D所见。具体地,当人造瓣膜54前进时,通过导管54的大略移动和在其角度朝向上的微小变化——通过用偏转驱动器154拉紧偏转线202,其被尽可能地沿天然主动脉瓣AV的流动轴线校准。
如以上所提及的,偏转线202(图10B)从手柄150沿球囊偏转管160延伸并终止于偏转段212,并且优选地终止于偏转段212的线圈弹簧的远端(未示出)。拉动偏转线202使偏转段212被拉向该线附接侧,因此使导管的远端和球囊52偏转,如图14D。
最终,瓣膜50如图3C中那样被正确地放置,注意,当膨胀时,瓣膜50不可能阻塞任何一个冠状动脉口80。混合有对照物的盐水随后通过穿过球囊扩张管196长度的球囊膨胀连接器152注射,以填充球囊52,如图14E所见。球囊52是具有最大膨胀直径的类型,该直径先前已经被选择,以恰当地膨胀人造心脏瓣膜52至其接触周围主动脉瓣AV和钙化小叶的最佳直径,如果钙化小叶仍在其位置上的话。该步骤在图3D中说明。球囊52膨胀人造心脏瓣膜50,以便将其植入环中,在此之后,将球囊收缩并从瓣膜内移出。
随后,可将放射照相对比剂从球囊导管54的近端路厄连接142注入,以通过远端软末梢144流出,并测试刚被植入的人造瓣膜50的效能。如果瓣膜合适地起作用,则将球囊导管54撤回入插管器套70中,将其从小孔32中移出。抽合式缝合线44被闭合,以密封小孔32。
再一次,在此描述的递送系统特别适于顺行、切顶进路,这部分是因为其相对短的长度。参考图4A,插管器100的整个长度大约13英寸(33cm),而可在体内延伸的套70的长度在大约20-24cm之间。延伸进入插管器100的球囊导管54的部分(即,从远端软末梢144至接近偏转手柄154的球囊导管的部分)优选地不大于大约24英寸(61cm),其允许球囊导管的大约11英寸(28cm)延伸超过插管器末梢72(见图4)。应该注意,递送系统的相对短的长度不适于通过外围脉管系统的更长、更迂回的进路,例如在Taylor的共同未决的美国专利公布2007-0005131号中示出的。同样地,操纵机构被设置在球囊导管54本身上,而不是在用于引导球囊导管的第二导管上,如在美国专利公布2007-0005131号中进行的。球囊导管的短长度和直接操纵其的能力大大提高了人造心脏在主动脉环中的成功定位。
尽管已经在其优选实施方式中描述了本发明,但应当理解已使用的词语是描述性的词语,而不是限制性的词语。因此,在所附权利要求内可进行改变,而不脱离本发明真正的范围。
Claims (20)
1.医学插管器和心脏瓣膜递送导管组合,包括:
递送导管,其具有足够直径的远端球囊以膨胀其上蜷曲的心脏瓣膜;以及
接收从其中通过的所述递送导管的插管器,其具有从近端外壳向远端延伸的细长管状套,所述近端外壳包含至少一个用于在所述递送导管的近端长度周围进行流体密封的插管器阀,所述套包括近端段和远端部分,所述近端段延伸所述套长度的至少一半的长度L并具有第一刚度,所述远端部分具有不同于所述第一刚度的第二刚度的长度l。
2.根据权利要求1所述的组合,其中所述长度l在大约4-12cm之间的范围内。
3.根据权利要求1所述的组合,其中所述长度L为至少24cm,所述长度l在大约6-9cm之间的范围内。
4.根据权利要求1所述的组合,其中所述管状套具有都延伸整个长度的内部衬垫和加强线圈,并且串联的外管的至少两个部分具有产生所述套的不同刚度的不同硬度。
5.根据权利要求1所述的组合,其中所述第二刚度小于所述第一刚度。
6.根据权利要求1所述的组合,其中所述递送导管具有导管管子,并且所述球囊位于由偏转拉线驱动的所述导管管子的可偏转部分的末端上,所述递送导管进一步包括在所述导管管子上滑动并相对于所述球囊纵向移动的管状瓣膜推进器,并且所述递送导管也具有近端控制手柄,在所述近端控制手柄上安装有用于偏转所述导管管子的可偏转部分的偏转驱动器和用于相对于所述球囊移动所述瓣膜推进器的推进器驱动器。
7.根据权利要求1所述的组合,其中所述递送导管具有近端控制手柄,并包括从所述控制手柄内延伸的多个同心管,和至少一个在所述手柄内用于在所述管的一个周围进行密封的被动式密封件,以便该一个管的移动决不被所述被动式密封件阻止。
8.根据权利要求1所述的组合,其中所述递送导管包括在所述导管管子上滑动并相对于所述球囊纵向移动的管状瓣膜推进器,和在大部分所述瓣膜推进器上延伸的保护套筒,以及限定接受所述递送导管的远端部分的通孔的管状加装器,并包括用于将接合结构啮合在所述插管器外壳的近端上的结构,所述加装器具有远端鼻,所述远端鼻延伸通过并打开所述插管器阀,并且促使所述递送导管的球囊通过其中,所述加装器具有带有被动式加装器密封件的近端外壳,以便所述保护套筒的移动决不被所述加装器密封件阻止。
9.医学插管器和心脏瓣膜递送导管组合,包括:
递送导管,其具有足够直径的远端球囊以膨胀其上蜷曲的心脏瓣膜,所述递送导管包括在所述球囊的近端处的标记带,所述递送导管也包括管状瓣膜推进器,所述管状瓣膜推进器在所述导管上滑动并相对于所述球囊纵向移动并具有远端标记带;以及
插管器,其具有从近端外壳向远端延伸的细长管状套,所述近端外壳包含至少一个用于在所述递送导管的近端长度周围进行流体密封的插管器阀,所述套具有用于通过所述递送导管的通孔和在其末梢周围的标记点阵列,以便将所述末梢与所述球囊和所述推进器的标记带区分开。
10.根据权利要求9所述的组合,其中所述递送导管具有导管管子,所述球囊位于由偏转拉线驱动的所述导管管子的可偏转部分的末端上,并且所述递送导管也具有近端控制手柄,在所述近端控制手柄上安装有用于偏转所述导管管子的可偏转部分的偏转驱动器和用于相对于所述球囊纵向移动所述瓣膜推进器的推进器驱动器。
11.根据权利要求10所述的组合,其中所述递送导管包括多个从所述控制手柄内延伸的同心管,和至少一个在所述手柄内用于在所述管的一个周围进行密封的被动式密封件,以便该一个管的移动决不被所述被动式密封件阻止。
12.根据权利要求10所述的组合,其中所述可偏转部分包括编织结构,并且所述偏转线沿其长度延伸直至所述偏转线附接的远端线圈,所述可偏转部分具有不大于8French的尺寸。
13.根据权利要求9所述的组合,其中所述递送导管包括在所述导管管子上滑动并相对于所述球囊纵向移动的管状瓣膜推进器,和在大部分所述瓣膜推进器上延伸的保护套筒,以及限定接受所述递送导管的远端部分的通孔的管状加装器,并包括用于将接合结构啮合在所述插管器外壳的近端上的结构,所述加装器具有远端鼻,所述远端鼻延伸通过并打开所述插管器阀,并且促使所述递送导管的球囊通过其中,所述加装器具有带有被动式加装器密封件的近端外壳,以便所述保护套筒的移动决不被所述加装器密封件阻止。
14.根据权利要求9所述的组合,其中收缩结构的所述球囊以仅留下纵向折叠线的方式折叠。
15.医学插管器和心脏瓣膜递送导管组合,包括:
递送导管,其具有足够直径的远端球囊以膨胀其上蜷曲的心脏瓣膜;
插管器,其具有从近端外壳向远端延伸的细长管状套,所述近端外壳包含至少一个用于在所述递送导管的近端长度周围进行流体密封的插管器阀;以及
限定接收所述递送导管的远端部分的通孔的管状加装器,包括用于将接合结构啮合在所述插管器外壳的近端上的结构和远端鼻,所述远端鼻延伸通过并打开所述插管器阀,并且促使所述递送导管的球囊通过其中,所述加装器具有带有用于在所述插管器套周围进行流体密封的加装器密封件的近端外壳,和用于从所述加装器内吸出空气的单手使用排放口。
16.根据权利要求15所述的组合,其中所述加装器密封件包括弹性排放构件,所述弹性排放构件与通过所述近端外壳侧面上的孔伸出的至少一个侧面按钮相连接,其中所述侧面按钮的操作引起所述排放构件变形,这又向大气打开所述近端外壳内的空间。
17.根据权利要求15所述的组合,其中所述递送导管具有导管管子,所述球囊位于由偏转拉线驱动的所述导管管子的可偏转部分的末端上,所述递送导管进一步包括在所述导管管子上滑动并相对于所述球囊纵向移动的管状瓣膜推进器,并且所述递送导管也具有近端控制手柄,在所述近端控制手柄上安装有用于偏转所述导管管子的可偏转部分的偏转驱动器和用于相对于所述球囊纵向移动所述瓣膜推进器的推进器驱动器。
18.根据权利要求15所述的组合,其中所述递送导管具有近端控制手柄并包括从所述控制手柄内延伸的多个同心管,和至少一个在所述手柄内的用于在所述管的一个周围进行密封的被动式密封件,以便该一个管的移动决不被所述被动式密封件阻止。
19.根据权利要求15所述的组合,其中所述递送导管包括在大部分所述瓣膜推进器上延伸的保护套筒,并且其中所述加装器密封件为被动式阀,以便所述保护套筒的移动决不被所述加装器密封件阻止。
20.根据权利要求15所述的组合,其中收缩结构的所述球囊以仅留下纵向折叠线的方式折叠。
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PCT/US2010/041909 WO2011008812A2 (en) | 2009-07-14 | 2010-07-14 | Transapical delivery system for heart valves |
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