CN101291637B - 具有瓣膜导管的心瓣膜输送系统 - Google Patents

具有瓣膜导管的心瓣膜输送系统 Download PDF

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CN101291637B
CN101291637B CN2006800389085A CN200680038908A CN101291637B CN 101291637 B CN101291637 B CN 101291637B CN 2006800389085 A CN2006800389085 A CN 2006800389085A CN 200680038908 A CN200680038908 A CN 200680038908A CN 101291637 B CN101291637 B CN 101291637B
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valve
artificial valve
delivery cannula
conduit
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CN101291637A (zh
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H·布拉格
T·H·勒
D·M·泰勒
S·索克
M·约比
R·康纳
D·J·埃文斯
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    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/02—Prostheses implantable into the body
    • A61F2/24—Heart valves ; Vascular valves, e.g. venous valves; Heart implants, e.g. passive devices for improving the function of the native valve or the heart muscle; Transmyocardial revascularisation [TMR] devices; Valves implantable in the body
    • A61F2/2427—Devices for manipulating or deploying heart valves during implantation
    • A61F2/243—Deployment by mechanical expansion
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/02—Prostheses implantable into the body
    • A61F2/24—Heart valves ; Vascular valves, e.g. venous valves; Heart implants, e.g. passive devices for improving the function of the native valve or the heart muscle; Transmyocardial revascularisation [TMR] devices; Valves implantable in the body
    • A61F2/2412—Heart valves ; Vascular valves, e.g. venous valves; Heart implants, e.g. passive devices for improving the function of the native valve or the heart muscle; Transmyocardial revascularisation [TMR] devices; Valves implantable in the body with soft flexible valve members, e.g. tissue valves shaped like natural valves
    • A61F2/2418—Scaffolds therefor, e.g. support stents
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/02—Prostheses implantable into the body
    • A61F2/24—Heart valves ; Vascular valves, e.g. venous valves; Heart implants, e.g. passive devices for improving the function of the native valve or the heart muscle; Transmyocardial revascularisation [TMR] devices; Valves implantable in the body
    • A61F2/2427—Devices for manipulating or deploying heart valves during implantation
    • A61F2/243—Deployment by mechanical expansion
    • A61F2/2433—Deployment by mechanical expansion using balloon catheter
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/02—Prostheses implantable into the body
    • A61F2/24—Heart valves ; Vascular valves, e.g. venous valves; Heart implants, e.g. passive devices for improving the function of the native valve or the heart muscle; Transmyocardial revascularisation [TMR] devices; Valves implantable in the body
    • A61F2/2427—Devices for manipulating or deploying heart valves during implantation
    • A61F2/2436—Deployment by retracting a sheath
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/02—Prostheses implantable into the body
    • A61F2/24—Heart valves ; Vascular valves, e.g. venous valves; Heart implants, e.g. passive devices for improving the function of the native valve or the heart muscle; Transmyocardial revascularisation [TMR] devices; Valves implantable in the body
    • A61F2/2427—Devices for manipulating or deploying heart valves during implantation
    • A61F2/2439—Expansion controlled by filaments
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/95—Instruments specially adapted for placement or removal of stents or stent-grafts
    • A61F2/9517—Instruments specially adapted for placement or removal of stents or stent-grafts handle assemblies therefor
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/95—Instruments specially adapted for placement or removal of stents or stent-grafts
    • A61F2/958—Inflatable balloons for placing stents or stent-grafts
    • A61F2002/9583—Means for holding the stent on the balloon, e.g. using protrusions, adhesives or an outer sleeve

Abstract

提供一种心瓣膜输送系统(10)，其中人造瓣膜(16)被装在输送套管(24)里面的瓣膜导管(23)上。阶段球囊(18)从输送套管伸出并且提供锥形的表面，用于方便前进通过人体脉管。该阶段球囊还有助于通过自体瓣膜的小叶。在人造瓣膜被定位在自体瓣膜内之后，该输送套管缩回以露出该人造瓣膜。在一个实施例中，输送套管通过利用丝杠(500)而被缩回，该丝杠在瓣膜导管和输送套管之间实现相对运动。人造瓣膜优选是自扩展的。如果需要，阶段球囊可以被扩展以牢固地将人造瓣膜安放在自体瓣膜部位处。人造瓣膜优选由多个柔性延伸臂(80)连接于瓣膜导管，在人造瓣膜的初始展开之后该柔性延伸臂使人造瓣膜能够皱缩，因此如有需要则人造瓣膜可以被重新定位。

Description

具有瓣膜导管的心瓣膜输送系统
技术领域
本发明通常涉及用于将医疗植入物输送到人体中的系统。更具体地说，本发明涉及用于将人造瓣膜输送到人的心脏中的输送系统。
背景技术
基于导管的手术通常用于医学临床治疗外科手术不容易接近的身体内的部位或外科手术不希望接近的部位。在一种基于导管的手术中，利用经皮的途径将人造瓣膜输送到人的心脏用于替代有缺陷的自体瓣膜。虽然利用经皮输送的人造瓣膜替代自体心瓣膜表现出极大的潜力，但是由于操作者引导通过病人脉管系统，例如通过小血管和主动脉弓周围的能力，这种手术的有效性经常受到限制。
在一种输送方法中，人造瓣膜被安装在球囊导管上。在将人造瓣膜送进到心脏之前，引导套被引进到病人的髂动脉中。虽然引导套增大系统的直径和复杂性，但是为了推进导管和人造瓣膜通过比较窄的动脉血管引导套是必须的。球囊导管和人造瓣膜由操作者推动通过引导套到治疗部位。这种手术的一个缺点是球囊导管缺少有效地推进通过该引导套所需要的可推动性。而且，在离开引导套之后，人造瓣膜可能与血管的内壁接触，例如沿着主动脉弓。这种接触的结果，血管壁可能受到损害并且人造瓣膜的前进可能被阻碍或者完全被阻止。而且，钙化和斑能够从血管壁上移开。
由于与现有输送系统相关的缺点，需要一种新的改进的输送系统，其能够用于以安全和有效的方式将人造瓣膜输送到人的心脏。希望这种系统不需要使用传统的引导套。还希望这种系统容易循迹行进(tracking)过程并减少斑或钙化沿着人体脉管内壁的位移。还希望这种系统具有足够的柔软性以循迹通过人体脉管的弯曲部分，同时提供足够的可推动性以确保人造瓣膜能够循迹行进到自体瓣膜部位。希望这种系统还提供用于以可控制的和精确的方式在自体瓣膜部位展开人造瓣膜的装置。本发明解决这种需求。
发明内容
用于治疗人的心脏中的自体瓣膜的系统的优选实施例包括包含人造瓣膜的输送套管，其不使用引导套而进入血管中。不使用引导套的进入通过阶段球囊的逐渐变化的外形实现，该阶段球囊的尖端从该输送套管的远端伸出并且提供从导丝/引导线(guide wire)到输送套管的平滑的过渡。
该输送套管由为导管提供足够可推动性、刚性和柔软性的材料构成，以使操作者能够将导管的远端精确地放置在人造瓣膜将要被展开的部位。阶段球囊的平滑过渡防止使血管内的钙化和斑变松，特别是在主动脉弓的区域。
该系统的另一个优点是为植入人造瓣膜布置自体瓣膜的部位的能力。有利的是在植入人造瓣膜之前使狭窄的小叶扩张。当阶段球囊被缩小，通过小叶之间的开口，并且然后再膨胀时小叶被扩大。
该系统的另一个优点是帮助越过自体瓣膜的部位以植入人造瓣膜的能力。阶段球囊提供过渡到该套的平滑的锥形尖端，用于容易越过钙化的小叶。
该系统的再一个优点是在展开之后拉回阶段球囊通过该人造瓣膜的能力。锥形尖端可以被收缩并且皱缩以利于拉回球囊通过该人造瓣膜。这个特征在拉回时有利地减少或消除损害人造瓣膜小叶或挂在瓣膜框架上的可能性。
在瓣膜展开的部位，输送套管拉回，允许阶段球囊充分扩展。瓣膜导管的远端包含柔性的延伸部分，该延伸部分在球囊膨胀时向外弯曲。该人造瓣膜连接于该柔性延伸部分，因而在展开时提供改进的稳定性和可控制性。
一方面，用于治疗人的心脏中的自体瓣膜的系统包括人造瓣膜、瓣膜导管和管状的输送套管。该人造瓣膜包括可扩展的框架和瓣状结构。该管状套管被构造成用于前进通过病人的脉管系统。该管状套管限定通道并且瓣膜导管被构造成可滑动地前进通过该通道。可释放的接合机构沿着该瓣膜导管的远端部分设置，用于接合该人造瓣膜。致动机构沿着该瓣膜导管的近端部分设置，用于使该可释放的接合机构释放人造瓣膜。
在一种变型中，可释放的接合机构包括多个柔性延伸臂，这些柔性延伸臂被构造成当人造瓣膜在治疗部位扩展时固定该人造瓣膜。该系统还可以包括至少一个缝合线(suture)用于将人造瓣膜固定于柔性延伸臂。至少一个可滑动件连接于该致动机构并且朝着人造瓣膜远端延伸。诸如金属丝的可滑动件是可收回的，用于从人造瓣膜上拆开该缝合线，因而从柔性延伸臂释放人造瓣膜。
在另一种变型中，该系统还可以包括从管状套管的远端延伸的可扩展的过渡件。在一种变型中，过渡件包括具有锥形远端部分的可膨胀的球囊。该可膨胀的球囊优选至少部分地设置在人造瓣膜内使得可膨胀球囊的膨胀有助于人造瓣膜的扩展。当系统包括可膨胀的球囊时，人造瓣膜的可扩展框架可以是球囊可扩展的或自扩展的。在一种变型，可扩展的吊舱(basket)可以用来代替可膨胀的球囊，用于提供扩张器或便于人造瓣膜的扩展。
在另一种变型中，手柄组件被提供用以可控制地拉回管状套管，使人造瓣膜暴露在治疗部位。在一个实施例中，手柄组件具有连接于该管状套管的远端部分和连接于瓣膜导管的近端部分。该手柄组件可以利用其他合适机构的丝杠，用于以可控的方式推进瓣膜导管并且牢固地保持该瓣膜导管和管状套管的相对位置。
在另一方面，提供一种在人类心脏的自体瓣膜内展开人造瓣膜的方法。该方法包括提供沿着远端部分具有可释放的连接机构的伸长的瓣膜导管。该人造瓣膜可连接于该可释放的连接机构。瓣膜导管和人造瓣膜被放置在管状套管中。该管状套管、瓣膜导管和人造瓣膜作为单一的单元被推进通过股动脉并且经过主动脉弓，直到该人造瓣膜基本上位于自体瓣膜内。该输送套管相对于该瓣膜导管缩回，以露出人造瓣膜，并且在瓣膜导管近端上的致动机构被致动以从瓣膜导管释放人造瓣膜。
在一种变型中，在推进人造瓣膜期间可膨胀的球囊被设置在人造瓣膜内。可膨胀球囊的锥形远端部分从管状套管延伸用于提供扩张器，以便于推进通过病人的脉管系统。在另一种变型中，可膨胀球囊可以用于通过将狭窄的小叶推向旁边来扩张自体瓣膜，因而便于将人造瓣膜插入自体瓣膜中。在又一种变型种，可膨胀球囊可以在缩回管状套管之后被膨胀，以便于扩展人造瓣膜并将人造瓣膜安放在自体瓣膜中。在又一种变型中，该系统的优选实施例在暴露人造瓣膜之后使管状套管能够相对于瓣膜导管被推进。管状套管的推进使人造瓣膜再一次皱缩，使得在初始展开不是所希望的情况下它能够重新定位。在重新定位人造瓣膜之后，套管可以再一次被拉回并且然后可以从瓣膜导管释放人造瓣膜。
另一方面，一种用于治疗人类心脏的装置包括人造瓣膜、具有近端的管状输送套管、连接在该管状输送套管的近端的丝杠螺母、以及具有远端部分的瓣膜导管，该远端部分被构造成用于可释放地连接于人造瓣膜，其中瓣膜导管和人造瓣膜可滑动地前进通过该输送套管。丝杠被连接于瓣膜导管。该丝杠与丝杠螺母啮合并且丝杠的旋转使瓣膜导管和人造瓣膜相对于输送套管前进。在一种变型中，可膨胀的球囊被设置在人造瓣膜内用于便于该人造瓣膜在自体瓣膜内的扩展。该可膨胀的球囊可以具有构造成从管状输送套管延伸的锥形远端部分。因此，可膨胀的球囊也可以用于促进前进通过脉管系统并且扩张自体瓣膜的狭窄的小叶。该管状输送套管优选用亲水涂层涂覆。在另一种变型中，沿着瓣膜导管的远端部分设置多个柔性延伸部分，该柔性延伸部分被构造成用于可释放地连接于人造瓣膜。
附图说明
图1是根据本发明的输送系统的优选实施例的侧视图，其中远端部分被剖开并以截面的形式示出；
图2是该输送系统的球囊导管的侧视图；
图3A和3B分别是球囊导管的球囊的截面图和透视图；
图4是图解说明形成输送系统一部分的瓣膜导管的近端和远端的侧视图；
图5是瓣膜导管的多轴腔的截面图；
图6A和6B分别是瓣膜导管的套爪(collet)的截面图和透视图；
图7A和7B分别是瓣膜导管的圆盘(puck)的截面图和透视图；
图8是瓣膜导管的拖把状物(mop)的透视图；
图9是形成该输送系统一部分的输送套管的侧截面图；
图10是沿该输送套管的主要部分的截面图；
图11是该输送系统的近端套筒(proximal hub)的侧截面图；
图12是连接于该输送系统的手柄组件的透视图；
图13A和13B分别是手柄组件的远端板组件的分解图和透视图；
图14A和14B分别是手柄组件的近端板组件的分解图和透视图；
图15是手柄组件的丝杠的侧视图；
图16是包括测力传感器(load cell)的手柄组件的一个实施例的透视图；
图17是包括测力传感器的手柄组件的另一个实施例的透视图；
图18是手柄组件的又一个实施例的透视图；
图19是输送系统的侧视图，其中该输送系统的近端套筒和远端部分以截面示出；
图20是拖把状物延伸部分和对应的人造瓣膜部分的截面图；
图21是图18的可替换手柄组件和该输送系统之间的组件的侧视图；
图22A和22B分别示出输送系统到达自体瓣膜部位并将患病的自体瓣膜小叶推开；
图23A至23E示出在用于输送并展开人造瓣膜的一种优选的使用方法期间该输送系统的远端部分；
图24是示出机械式吊舱尖端的输送系统的可替换实施例的侧视图。
具体实施方式
现在参考图1，一种心瓣膜输送系统10通常包括：导丝12和具有沿着远端部分设置的可膨胀的球囊18的球囊导管14。可扩展的人造瓣膜16位于该可膨胀的球囊上。该球囊导管14还包括伸长的球囊轴20和在其近端的支撑件22。球囊导管14的球囊轴20被接纳在瓣膜导管23内。正如将在下面更详细地描述的，该瓣膜导管23构造成用于可释放地与人造瓣膜16接合。瓣膜导管23被接纳在管状输送套管24内，其中球囊18至少部分地从该输送套管24的远端伸出。输送套管24的近端被安装在近端套筒(hub)26上。将在下面更详细地讨论并描述的手柄组件500可以连接于该输送套管24的近端套筒26，以实现人造瓣膜16相对于该输送套管24在控制下的推进。
参考图2，球囊导管14被更详细地示出。球囊导管14配备有限定导丝腔的导丝轴31。支撑件22沿着该球囊导管的近端设置并且包括主轴32和从该主轴32斜向延伸的流体轴34。停止旋塞35沿着该流体轴34设置。主轴32和流体轴34各自包括通道，并且这些通道彼此连通。诸如在美国专利6,592,544号中公开的Touhy Borst阀36从主轴32的近端朝着近端延伸，并且包括在其近端处的紧固阀37，该美国专利的内容作为参考被完全并入本文。所示的球囊轴20大体为管形并且包括外表面38。
在一个优选结构中，该球囊导管14被装配，以使该球囊轴20的外表面38固定于该支撑件22的主轴32的内表面。该Touhy Borst阀36被设置在该主轴32的近端上并且在两个部件之间用螺纹连接与其固定。在该Touhy Borst阀36内部的压缩阀围绕导丝轴31，并且当该紧固阀37被拧紧时，该压缩阀密封该支撑件22的主轴32中的内部通道，使其与空气隔离。
参考图3A和3B，可膨胀的球囊18具有近端部分40和远端部分42，并且包括内表面44、外表面46和通过其纵向地延伸的通道48。当从近端部分40向远端部分42观察时，所示球囊18的实施例包括七个区域：第一细长区域50、第一圆锥形区域52、主圆柱形区域54、第二圆锥形区域56、辅助圆柱形区域58、第三圆柱形区域60以及第二细长区域62。该球囊18优选用诸如盐水的流体来膨胀，并且可以用任何合适的材料形成，例如尼龙。球囊18的远端部分42的形状被优选成形，以在导丝12和相对大的直径的输送套管24之间提供过渡构件(如图1所示)，因而利于该输送系统前进通过患者的脉管系统。在优选实施例中，球囊18还提供扩张器尖端，因而不需要单独的扩张器机构。球囊的外表面和输送套管优选配备有光滑的涂层。球囊的光滑的涂层和形状使输送系统(包括人造瓣膜)能够前进通过患者体内相对窄的和/或钙化的脉管系统。因此，在一种有利的特征中，可以使用该输送系统的优选实施例而不需要引导套/引导鞘(guide sheath)。
通过参考图1至图3B来更加详细地描述球囊18的一种优选的结构。球囊18的第一细长部分50的内壁44在球囊轴的远端固定于球囊轴20的外表面38，因此将球囊轴20的通道设置为与球囊18的通道48连通。第二细长部分62的内壁44固定于导丝轴31的外表面64。这种连接可以通过粘合或热连接，或者这两者来实现。通道70延伸通过柔软尖端68其中，该柔软尖端68在导丝轴31的远端固定于导丝轴31的外表面64，并且从导丝轴31向远端延伸，并且该柔软末端68的通道70与导丝轴31的通道71相连通。
通过参考图4至图8来更加详细地描述瓣膜导管23的组件和功能。如图4所最佳示出的，该瓣膜导管23提供用于固定和释放人造瓣膜16的可释放的接合机构。在所示的实施例中，瓣膜导管23包括多腔轴72，围绕该多腔轴的近端部分设置加劲管(stiffener tube)74。套爪(collet)76从多腔轴72的中心腔的内部延伸，并且被卡接在圆盘(puck)78中。该圆盘78被卡接在拖把状物(mop)80中，使得该拖把状物从该圆盘朝远端/远端地延伸。瓣膜导管23还包括从多腔轴72的近端朝近端/近端地延伸的金属丝管82。正如在下面所描述的，瓣膜导管23将人造瓣膜16输送到自体瓣膜部位并且有助于人造瓣膜16的展开。
参考图5的截面图，多腔轴72的形状优选地成形为圆柱形，并且包括通过其中纵向延伸的中心腔84。六个侧腔86从该多腔轴72的近端向远端延伸。在一个实施例中，多腔轴由诸如聚醚嵌段酰胺，就是通常所说的
Figure S2006800389085D00071
的热塑性弹性体制造。
参考图6A和6B，套爪76通常是圆柱形形状的并且包括近端90和远端92。中心通道94延伸通过该套爪。靠近近端90，开口96从该套爪76的外表面98向内表面100延伸。四个纵向狭槽102沿着该套爪76的远端92从外表面98通到内表面100，因而形成四个柔性臂104。狭槽102优选从远端92到近端90在宽度上变窄。在套爪76的远端92处，外表面优选地形成成角度的表面106，以有助于与圆盘78的接合。环形形状的凸缘108被设置在近端邻接于该成角度的表面106。沿着套爪76的圆周，外表面98包括凸肩表面109，其垂直于外表面98延伸并且面向该套爪76的远端92。
参考图7A和7B，圆盘78通常为管形形状，并且具有从近端114向远端116纵向地延伸通过该圆盘的中心腔112。该中心腔112由该圆盘78的内表面118限定。该圆盘78的外表面120靠近近端114包括成角度的部分122。环形槽123邻近成角度的部分122，围绕该圆盘78的外表面向远端延伸。靠近远端116，外表面120包括围绕该圆盘78的圆周延伸的卡接脊(snap ridge)124。该卡接脊124被从外表面120延伸的四个圆形凹槽(indentation)125中断。外表面还包括向外延伸的环形形状的凸缘126，其限定凸肩表面130。六个侧腔136从该圆盘78的外表面120的成角度的部分122向圆盘78的远端116平行于中心腔112延伸。这些侧腔136围绕圆盘78的圆周等距离间隔开。圆柱形形状的开口138从该圆盘78的外表面120向内表面118径向地延伸。销子139被插入该开口138中，与外表面齐平并且从圆盘78的内表面118向内伸出。
参考图8，拖把状物80通常为圆柱形形状，并且包括近端140、外表面142、内表面144和延伸通过该拖把状物的通道145。该拖把状物80优选包括六个伸长的延伸部分150，这些延伸部分被构造成用于与人造瓣膜接合。在一个优选实施例中，延伸部分150具有变化的长度，这些变化的长度被构造成用于接合人造瓣膜的不同的部分。每个延伸部分优选地包括靠近远端156的第一开口152和第二开口154。靠近拖把状物80的近端140，四个开口146从外表面142向内表面144延伸，并且沿着拖把状物80的圆周对齐。四个狭槽148从近端140沿着拖把状物80的长度延伸，从外表面142通向内表面144，并且在开口146之间通过。该拖把状物80优选由诸如镍钛(Nitinol)的形状记忆材料，或任何其他合适的材料制造。
继续参考图4至图8，在组装瓣膜导管23时，圆盘78被卡接在拖把状物80的近端140中。当圆盘的远端116被插入拖把状物80的通道145中时，狭槽148使拖把状物80的近端140能够弯曲(见图7A和图8)。圆盘78的卡接脊124进入拖把状物80的开口146中，并且圆盘78的狭槽凹槽125与拖把状物80的开口146之间的区域对齐。拖把状物80的近端140邻接圆盘78的凸肩表面130。弹簧夹头76卡接在圆盘78中。更具体地说，套爪76的远端92穿过圆盘78的近端114。套爪76的臂状物104弯曲，以穿过圆盘78的中心腔112。圆盘78的伸出部分138穿过套爪76的狭槽102中的一个，并且当狭槽102变窄时被压紧。一旦卡接之后，套爪76的凸缘108支承圆盘78的远端116，并且套爪76的凸肩表面109支承圆盘78的近端114。
多腔轴72设置在圆盘78上的近端。包括开口96的套爪76的近端90被插入该多腔轴72的中心腔84中，使得该多腔轴72的侧腔86与圆盘的侧腔136对齐，套爪76的开口可以用粘性材料填充，以便确保牢固结合。该多腔轴72和套爪76之间的连接可以通过热接合或粘着接合，或者这两者实现。加劲管74靠近其近端设置在多腔轴72上。该加劲管74在该多腔轴72的一部分上延伸。金属丝管82结合在该多腔轴72的近端并且从其斜向延伸。
参考图9和图10，输送套管24优选包括近端160、远端162、外表面164、内表面166以及纵向延伸通过该输送套管的通道168。该输送套管24包括主要部分170和尖端部分172。正如在下面所讨论的，在前进通过患者的脉管系统到自体瓣膜部位时该输送套管24包含并保护人造瓣膜。该输送套管24的主要部分170包括内层173，设置在该内层上的中间层174，设置在该中间层上的外层176。该输送套管24的主要部分170的内层173优选用诸如特富龙
Figure S2006800389085D00091
的具有低摩擦系数的材料形成。中间层174和外层176优选用
Figure S2006800389085D00092
形成。该输送套管的至少一部分可以用光滑的材料涂覆。该输送套管24还包括优选用不锈钢制造的多个金属丝178，这些金属丝沿着输送套管10的长度成螺旋形。
该输送套管24优选通过挤压工艺形成。在挤压工艺过程中这些金属丝起初被放置在该输送套管24的中间层和外层之间。然后该输送套管24通过加热使中间层和外层流动而被层压(laminate)。层压加工的热量软化中间层174和外层176，使金属丝178埋入输送套管24的中间层和外层中，如图10所示。当在层压加工的过程中加热时，优选用特富龙
Figure S2006800389085D00101
形成的内层173不流动。
在一个优选结构中，金属丝178的一半沿着与金属丝178另一半相反的方向沿着输送套管24的长度成螺旋形，因此，金属丝178彼此交叉形成网状。该金属丝178还彼此在其上和其下通过以形成织物或编织物。金属丝178在输送套管24的主要部分170中从输送套管24的近端160向远端162延伸。输送套管24的尖端部分172不包含设置在该输送套管24的主要部分170中的金属丝105，以确保适当的刚度和可推动性。
输送套管12的尖端部分172优选由诸如
Figure S2006800389085D00102
的柔软材料制造。在输送套管24的尖端部分172没有金属丝178和内层172。该尖端部分172被构造，以使得通道168在输送套管24的尖端部分172中的大小与它在该输送套管24的主要部分170中的大小相同。接近该输送套管的远端162，和在输送套管24的尖端部分172，外表面164逐渐变细，形成锥形的外表面180，正如在下面所描述的，这有助于该输送系统10的引进和在人体脉管内的循迹行进。
在该输送套管的主要部分170和尖端部分172之间的过渡部分，不透射线带182被设置在该输送套管24的不锈钢金属丝178和外层176之间。在上述加热层压加工过程中，不透射线带182不流动。在层压完成之后，该不透射线带182围绕金属丝178的端部保持，并且因此用作外层176和金属丝178之间的屏障。该不透射线带182可以包括任何合适的材料，但是优选用包括90％的铂和10％的铱的合金(PLIR)制造。
现在参考图11，图11提供沿着该输送套管24的近端套筒26的截面图。该近端套筒26优选包括圆柱形形状的套筒主体200，该套筒主体200具有纵向延伸通过该套筒主体的通道201。套筒主体200部分地由设置在该套筒主体200远端的壳体202围绕。延伸进入该套筒主体200的通道201中的具有开口204的端件203被安装在套筒主体200的近端并且从其伸出。当从近端向远端观察时，该端件203的外表面包括锥形表面205A、第一瓶颈表面205B、面向远端的第一凸肩表面205C、第二瓶颈表面205D和面向近端的第二凸肩表面205E。该第一凸肩表面205C、第二瓶颈表面205D和第二凸肩表面205E限定围绕该端件203延伸的槽206。
近侧地邻近该端件203并在该套筒主体200内部，设置十字形阀207，并且该十字形阀被隔离物(spacer)208部分地围绕，近侧地邻近该十字形阀206和该隔离物208并且在该套筒主体200内部，设置圆盘阀210。鸭嘴形阀212也被设置在套筒主体200内部，其近侧邻近该圆盘阀210。止血开口212从通道201延伸，并且止血管214从套筒主体200向三路停止旋塞216延伸。近端套筒的一个优选实施例详细地描述在名称为“血管内的输送系统(ENDOVASCULAR DELIVERYSYSTEM)”的美国专利5,968,068号中，其内容通过参考全部并入本文。
继续参考图11，该输送套管24固定于该近端套筒26。该输送套管24的近端160在其远端被插入该近端套筒26的通道201中。输送套管24的外表面164通过粘着接合或热接合固定于近端套筒26的壳体202的内表面，因此，以将近端套筒的通道201设置为与该输送套管24的通道168相连通。
通过参考图12至图15来描述手柄组件500的一个优选实施例。图解说明的手柄组件500提供机械致动机构，用于以可控和精确的方式从该输送套管24的远端推进人造瓣膜。该手柄组件500通常包括远端板组件502，其连接于在该输送套管24的近端上的近端套筒26。该手柄组件还包括近端板组件504，其连接于瓣膜导管23。丝杠506穿过该远端板组件502和近端板组件504。
具体参考图13A和13B，该远端板组件502包括主要部分510、上部512和丝杠螺母514。该主要部分510和上部512组合，以包括从该远端板组件502的近侧面518通到远侧面520的第一开口516。该第一开口516由近侧开口表面522、远侧开口表面524和凸肩表面525限定。该近侧开口表面522和远侧开口表面524从该远端板组件502的近侧面518和远侧面520垂直地延伸。该凸肩表面525面向近侧，并且在该远端板组件502的近侧开口表面522和远侧开口表面524之间基本上平行于远端板组件502的近侧面518和远侧面520延伸。在该远端板组件502中的第二开口526从近侧面518向远侧面520延伸。同样延伸通过该远端板组件502的紧固件开口527被设置在第二开口526的区域中。
丝杠螺母514为管形形状，具有外表面528、内表面530和纵向延伸通过该丝杠螺母的开口532。向外延伸的凸缘534邻近该丝杠螺母514的近端536向外延伸。紧固件开口538通过该凸缘534到该丝杠螺母514的近端536。该丝杠螺母514的内表面530是螺纹的。
该远端板组件502的上部512用远端板组件紧固件540固定于该远端板组件502的主要部分510，该远端板组件紧固件540啮合远端板组件紧固件孔542。该远端板组件紧固件孔542通过该远端板组件502的上部512并进入该远端板组件502的主要部分510中。
当该丝杠螺母514的近端536放置在该主要部分510的远侧面520上时，该丝杠螺母514固定于该远端板组件502的主要部分510，并且该主要部分510的紧固件开口527与丝杠螺母514的紧固件开口538对齐。丝杠螺母514中的开口532与远端板组件502的第二开口526对齐。丝杠螺母紧固件544啮合紧固件开口527和538，并且将该丝杠螺母514固定于该远端板组件502的主要部分510。
参考图14A和14B，近端板组件504包括主要部分546、盖部分548和从该主要部分546延伸的手柄550。该主要部分546和盖部分548组合以形成从近侧面554通过到远侧面556的中心开口552。该中心开口552由近侧开口表面558、远侧开口表面560和内腔表面562限定。该近侧开口表面558和远侧开口表面560从该近端板组件504的近侧面554和远侧面556垂直地延伸。该内腔表面562在近侧开口表面558和远侧开口表面560之间延伸，并且在组装的近端板组件504内形成开口的内腔。
在近端板组件504中的第一侧开口564从该近侧面554向远侧面556延伸。该手柄550固定于该近端板组件504的主要部分546，使得它通过该第一侧开口564并且用定位螺钉565固定。在近端板组件504中的第二侧开口566也从该近侧面554向远侧面556延伸。该近端板组件504的盖部分548用近端板组件紧固件568固定于该近端板组件504的主要部分546，该近端板组件紧固件568啮合近端板组件紧固件孔570。该近端板组件紧固件孔570通过该近端板组件504的盖部分548并进入该近端板组件504的主要部分546。
参考图15，该丝杠506包括在其近端的旋转器旋钮572、无螺纹部分574和邻近其远端的螺纹部分576。该旋转器旋钮572包括从其朝着远端延伸的颈部578，并且该无螺纹部分574从该颈部朝着远端延伸。在该旋转器旋钮572的颈部578的远端处的凸肩表面580面向远端。槽581围绕该丝杠506的圆周延伸。
参考图12至图15，当丝杠506被放置为通过该近端板组件504的第二侧开口566和丝杠螺母开口532以及远端板组件502的第二侧开口526，使得旋转器旋钮572的凸肩表面580邻靠该近端板组件504的近侧面554时，该手柄组件500被组装。卡接环582被设置在该丝杠506的无螺纹部分574上的槽581中，使得它邻靠该近端板组件504的远侧面556。该远侧面556上的卡接环582和该近侧面554上的凸肩表面580防止该丝杠514通过该近端板组件504的第二侧开口556的平移，该丝杠506在该近端板组件504的第二侧开口556中旋转。丝杠506的螺纹部分576啮合该丝杠螺母514的带螺纹的内表面530。
参考图16，图16示出该手柄组件500的可替换实施例，其中该丝杠螺母514从该远端板组件502近侧地设置。中间板590围绕该丝杠螺母514，并且丝杠螺母紧固件544将该中间板590固定于该丝杠螺母514。该中间板590固定于测力传感器(load cell)592，该测力传感器固定于远端板组件502。如图16所示的测力传感器592在本领域是公知的，并且可以以本领域公知的方式连接于测量该测力传感器592的位移的装置(未示出)。该装置将测力传感器592的位移转换成被作用的力，该力相对于该中间板590移动该远端板组件502。
参考图17，该手柄组件500的另一个可替换实施例包括朝着手柄550延伸的该中间板590的分叉的部分594，该手柄通过该分叉的部分594的开口596。第二手柄598通过该远端板组件502，并且由第二定位螺钉600固定，该第二定位螺钉600通过该远端板组件502与该第二手柄598接触。在该远端板组件502中的手柄开口602使固定于该近端板组件504上的手柄550能够毫无阻挡地通过该远端板组件502。
参考图18，图18图示说明另一种可替换的手柄组件608，其中不需要该近端板组件和远端板组件。中空的轴610包括与其平行延伸的卡接件612。该卡接件612由在该轴610和该卡接件612之间延伸的桥接件614连接于该轴610。在远端，该卡接件612包括朝着该轴610向里延伸的凸缘616，形成面向近侧的表面618。具有内螺纹表面的展开旋钮620可旋转地连接于该轴610。
现在参考图19来更详细地描述该输送系统10的功能性。球囊导管14被构造成用于插入瓣膜导管23中。球囊轴20被设置在多腔轴72的中心腔84中，并且球囊轴20的外表面38，例如通过粘着固定于该多腔轴72的内表面。该球囊轴20从近端地位于该多腔轴72的近端的支撑件22延伸，通过该多腔轴72的中心腔84，通过该套爪76的通道94，通过该圆盘78的中心腔112，到达拖把状物80的通道145。该球囊18的主要圆柱形部分54从该拖把状物80的远端156朝着远端延伸。人造瓣膜16卷缩成足够小以进入该输送套管24的通道168。人造瓣膜16由该球囊18的主要圆柱形部分54支撑并且被放置在该输送套管24的尖端部分172的区域中的内表面166上，该人在瓣膜被包含在其中并且循迹行进到自体瓣膜部位。
该输送系统10优选地被构造成与自扩展的人造瓣膜16一起使用。在一个优选实施例中，人造瓣膜至少部分地由诸如镍钛(Nitinol)的记忆材料形成，其中该人造瓣膜采用在预定温度下的刚性形状，但是在较低的温度下是比较有延展性的。这种自扩展的人造瓣膜的示例详细地描述在2004年9月23日公布的美国专利公开第2004/0186563 A1号中，其内容通过参考完全并入本文，但是应当理解，本发明的许多特征也可以与其他类型的人造瓣膜一起使用，诸如，例如球囊可扩展的瓣膜。优选的球囊可扩展的人造瓣膜的示例公开在名称为“可植入的人造瓣膜(Implantable Prosthetic Valve)”的美国专利6,730,118号和名称为“可植入的人造瓣膜(Implantable Prosthetic Valve)”的美国专利6,893,460号中，两者的内容通过参考结合于此。
继续参考图19，输送套管24和近端套筒26被设置在瓣膜导管23上。该瓣膜导管23通过该端件203的开口204、近端套筒26(包括阀207、210和212)的通道201和输送套管24的通道168(见图11)。近端套筒26被设置在瓣膜导管23的近端附近，其中加劲管74进入近端套筒26的通道201(见图11)并且从其朝着远端延伸。人造瓣膜16被设置在该输送套管24的远端162附近的通道168中(见图11)。当经受比体温低的温度时，自扩展的人造瓣膜16能够卷缩以便安装在输送装置里面。球囊18从该输送套管24的远端162朝着远端伸出。
导丝12被插入导丝轴31的通道71中。该导丝12从该导丝轴31的远端和柔软的尖端68朝着远端延伸，并且从该导丝轴31的近端朝着近端延伸。
成束的金属丝234延伸通过该金属丝管82。该成束的金属丝形成优选的致动机构的一部分，用于从瓣膜导管释放人造瓣膜到治疗部位处。该成束的金属丝234由六根单个的金属丝构成，这些单个的金属丝在金属丝管82的末端离开该金属丝管82，并进入该多腔轴72的六个侧腔86。旋钮236位于该成束的金属丝234的近端上。该成束的金属丝234的六根单个的金属丝离开该多腔轴的远端，并进入该圆盘78的侧腔136中(见图7A和7B)。该成束金属丝234的六根单个的金属丝在该圆盘78的远端116离开该侧腔136并朝着该拖把状物80的远端156延伸。
热收缩器(heat shrink)237能够用于增强该多腔轴72、金属丝管82和球囊导管14之间的连接。该热收缩器237被设置在该金属丝管82、多腔轴72和该支撑件22的主轴32上，并且被热处理直到它围绕这些部件形成变硬的外壳，从而将它们相互固定并且使该输送系统10更加牢固。
现在参考图20来描述一种用于将该人造瓣膜16可释放地连接到瓣膜导管的优选装置。一般地说，人造瓣膜16优选由提供系绳(tether)和勒除(snare)机构的可弯曲伸长件连接于瓣膜导管的拖把状物80部分(见图8)。为了实现这一目的，一个或多个缝合线(suture)238(系绳)通过部分人造瓣膜并且通过该瓣膜导管的拖把状物80部分。该缝合线238优选地包括延伸通过部分人造瓣膜的圈。(一个或多个)可滑动的金属丝234延伸通过该圈以防止该缝合线从人造瓣膜脱开。因此，可滑动的金属丝234提供可释放的勒除机构，该勒除机构能够被抽出用于快速地并容易地从该人造瓣膜脱开该缝合线。
在图20所示的优选实施例中，人造瓣膜16的近端部分被设置在该拖把状物80的内表面144的第二开口154附近。金属丝234的六根单个的金属丝从该圆盘78的侧腔136延伸(见图7A)并且压靠在该拖把状物80的延伸部分的150的内表面144上。该单个的金属丝沿着该人造瓣膜16的侧面通过，其中该人造瓣膜16被设置在拖把状物80的内表面144和该单个的金属丝之间。这些单个金属丝的远端能够被藏进/包进该人造瓣膜16的合缝袋中(commissure pocket)或者在该人造瓣膜16的合缝柱(post)处的小叶之间，以避免暴露于该输送套管24，同时在展开时循迹行进在且循迹行进到人体脉管。
诸如由缝合线或其他材料形成的环的锚定物优选被提供在圆盘78的环形槽123中(见图7A)。该缝合线238系于该锚定物中，并且然后沿着拖把状物80(见图8)的外表面142从该锚定物通过。在那上面缝合线通过该拖把状物80的延伸部分150其中之一的第一开口152，环绕金属丝234的单个金属丝，并通过第一开口152返回到拖把状物80的外表面142。然后缝合线238通过该拖把状物80的延伸部分150其中之一的第二开口154，通过人造瓣膜16的连接开口239，围绕该单个的金属丝234，通过人造瓣膜16的连接点返回，并且通过拖把状物80的同一个延伸部分150的第二开口154返回到拖把状物80的外表面142。该缝合线238系在圆盘78的环形槽123处的锚定物中，使得它形成从该锚定物延伸到拖把状物80(见图8)的延伸部分150的远端156的缝合线圈。该缝合线238用于形成对应于该拖把状物80的每个延伸部分150的类似的缝合线圈，其中系绳和勒除机构被形成在拖把状物80的每个延伸部分150的远端156附近。缝合线238绕其自身缠绕，并且在沿着每个延伸部分150的外表面142通过之前系在与拖把状物的每个延伸部分150对齐的位置，以形成缝合线圈。
再参考图12至图18，来更加详细地描述手柄组件500与输送系统10的连接。近端板组件504抓牢插入该近端板组件504的中心开口552中的瓣膜导管23。瓣膜导管23的加劲管74(见图4)接触该近端板组件504的近侧开口表面558和远侧开口表面560(见图14A)。该接触足够紧，以至于能够将该瓣膜导管23固定于近端板组件504。
远端板组件502被固定于近端套筒26上。端件203通过该远端板组件502的第一开口516(见图13B)，其中该远端板组件502接合该端件203的槽506(见图11)。该端件203的第一瓶颈表面205B(见图11)靠在远端板组件502的近端开口表面522上(见图13A和13B)。端件203的第一凸肩表面205C(见图11)靠在远端板组件502的凸肩表面525上(见图13A和13B)。端件203的第二瓶颈表面205D(见图11)靠在远端板组件502的远侧开口表面524上(见图13A和13B)。端件203的第二凸肩表面205E靠在远端板组件502的远侧面520上(见图13A和13B)。
图16和图17所示的实施例很适合于使操作者能够知道当人造瓣膜16离开输送套管24时作用在人造瓣膜16上的力，这将在下面描述。由于延伸的远端板组件502和第二手柄598使绕由瓣膜导管23限定的轴线的重量的均匀分布，图17所示的实施例适合于稳定手柄组件500。分叉的部分594除了用作绕由瓣膜导管23限定的轴线均匀地分布重量的装置之外，还用于防止在瓣膜展开和丝杠506操作时该装置在应力作用下的旋转，这将在下面描述。
在图18所示的可替换实施例中，通过将轴610卡接在近端套筒26中(见图11)中，手柄组件608被连接于输送系统10，如图21所示。该轴610进入端件203的开口204中(见图11)。卡接件612的凸缘616在锥形表面205A和第一瓶颈表面205B上通过，以接合端件203的槽206(见图11)。卡接件612的面向近侧的表面618靠在近端套筒26的端件203的第一凸肩表面205C上。展开旋钮的内螺纹表面啮合瓣膜导管23的螺纹表面622。瓣膜导管23的螺纹表面622可以包含在加劲管74中(见图4)。
现在参考图1至图11，来更加详细地描述利用该输送系统10输送人造瓣膜16的优选方法。按照现有技术公知的方法，首先将导丝12插入人体脉管中，例如股动脉。该导丝12通过病人的动脉，并且通过自体瓣膜的开口。如果希望，可以将扩张器插入该导丝12上进入体腔。一种优选的扩张器详细描述在名称为“血管内的输送系统(EndovascularDelivery System)”的5,968,068号美国专利中，其内容通过参考全部结合于此。该扩张器用来增大人体脉管的开口，因而便于使该输送系统10进入人体脉管内。在脉管扩张并且输送系统10进入人体脉管之后，该扩张器被取出。但是，正如上面所讨论的，由于球囊和输送套管的形状和涂层，不用扩张器也可以使用该输送系统的实施例。
输送系统10在导丝12上循迹行进并且进入人体脉管中。亲水涂层优选用于在球囊18(见图3A)的外表面46和输送套管24(见图11)的外表面164上提供光滑性。光滑的表面通过减少与人体脉管壁之间的摩擦力的量，使装置容易进入并且容易推动该装置到自体瓣膜部位，其中该装置通过该人体脉管壁循迹行进。该球囊18的第二圆锥部分56的外表面46(见图3A和3B)提供锥形表面，以便容易进入人体脉管中。在输送套管24的远端162处，该输送套管24的尖端部分172的锥形表面180(见图9)也便于进入该人体脉管中。
现在参考图22A，当输送系统10向自体瓣膜部位250循迹行进时，其在导丝12上通过。当操作者以逆行(即与血流反向)的过程推动该输送系统10通过该股动脉，越过主动脉弓254并到达自体瓣膜部位250时发生循迹行进。循迹行进时球囊18用于充当人体脉管内的扩张器。人体脉管由于其大小和钙化作用可能是收缩的。球囊18提供锥形的柔软的表面，用于当输送系统10的远端通过人体脉管前进时，逐渐扩张人体脉管的狭窄的区域。如果需要，该球囊可以部分地或整个地缩小，并且然后在前进时重新膨胀，以进一步便于前进通过狭窄的脉管系统。输送套管24的结构赋予它足够的柔软性和可推进性，以循迹行进到自体瓣膜部位250。透视法使操作者知道输送系统10的位置，其中可以看见输送套管24的不透射线带182(见图9)相对于该自体瓣膜部位250的位置。
在输送系统10向自体瓣膜部位循迹行进的过程中，该输送套管24弯曲以便通过人体脉管的弯曲部分，包括在主动脉弓254中存在的弯曲部分。输送套管24的弯曲可以使瓣膜导管23的部件相对于该输送套管24的内表面166(见图9)移动。该弯曲还可以使该输送套管24的通道变窄，因而增加摩擦。因此，输送套管24的优选实施例具有用诸如
Figure S2006800389085D00181
的具有低摩擦系数的材料形成的或涂覆的内表面166。
在向自体瓣膜部位250循迹行进时由于输送套管24弯曲，因此弯曲力被施加在金属丝178上(见图10)。作用在金属丝178上的力使金属丝178压在该输送套管24的中间层174和外层176上。因此，不透射线带182(见图9)优选地由具有足够的抗穿刺性的材料制造，使得当该套管24弯曲时由该金属丝178的端部作用的力不能刺穿该输送套管24的外层176。输送套管24的内层173(见图10)也对瓣膜导管23和球囊导管14提供保护免受金属丝178的损害。被选用为该内层173的材料在上面所述的加热层压处理中不流动。金属丝178不会嵌进该内层173中。因此内层173在金属丝178和输送套管24的通道168之间提供屏障。
参考图22B，一旦输送系统10已经到达瓣膜部位，操作者能够将人造瓣膜16(见图1)推过自体瓣膜小叶256，从而解除已经变得狭窄的小叶256。主动脉狭窄是心脏的主动脉瓣的疾病。狭窄的小叶变厚、变硬并且钙化；它们的运动比健康的小叶受更多的限制。变窄的小叶阻碍血液流动，只留下很小的孔使血液能够注入主动脉。瓣膜移植可能要求小叶被去掉或被推向旁边。但是，狭窄的小叶的变硬的性质使解除过程变复杂。
膨胀时球囊18能够变硬并且能够用于扩张自体心瓣膜的变窄的小叶。球囊18被缩小并且球囊18的第二圆锥形部分56通过该变窄的小叶之间的小孔。然后球囊18重新膨胀，如图22B所示，并且扩展的球囊对狭窄的小叶的变硬的组织施加足够的压力，以扩张小叶。这种扩张有助于人造瓣膜16的展开(见图19)，这将在下面进行描述。
在瓣膜展开的优选方法中，当瓣膜导管23保持固定时该输送套管24被缩回，将人造瓣膜16暴露在移植部位而不需要人造瓣膜在暴露于体腔时循迹行进通过体腔。而且，在引入人体脉管并且循迹行进通过人体脉管时，由于瓣膜相对于输送套管24保持静止，因此不需要使瓣膜通过导向或引进套。
在图12、16和17所示的实施例中，其中采用手柄组件500，操作者转动旋转器旋钮572以缩回输送套管并且因而将人造瓣膜暴露在人体脉管并且完成展开。丝杠506的螺纹部分576的螺纹作用在丝杠螺母514的内螺纹上，使丝杠螺母514和远端板组件502朝着近端板组件504平移，该近端板组件504相对于丝杠506由卡接环582保持平移中的静止。因此，该远端板组件502和近端板组件504相对于彼此移动，这使在近端套筒26的端件203处连接于该远端板组件502的输送套管24和固定于近端板组件504的瓣膜导管23相对于彼此移动。
在图18和图21所示的采用可替换手柄组件608的可替换实施例中，操作者转动展开旋钮620，使得旋钮620、以及连接于该展开旋钮620的近端套筒26和输送套管24在瓣膜导管23上朝着近端移动。
丝杠506或可替换手柄组件608的使用潜在地减少从人造瓣膜16缩回该输送套管所需要的力。该丝杠506旋转一周使丝杠螺母514在该丝杠506的螺纹部分576上前进单个螺纹之间的距离。称之为螺距的螺纹之间的距离确定操作者致动该旋转器旋钮572所需要的力的量。螺距越小，该旋转器旋钮572每旋转一圈实现的平移运动越小。一方面该输送套管24的相对平移运动越小，另一方面人造瓣膜和瓣膜导管19的相对平移运动越小，该系统的操作者需要的力越小。在本发明的优选实施例中，该丝杠具有1/4英寸的螺距。
在不采用丝杠的本发明的可替换实施例中，操作者使瓣膜导管23在近端套筒26上保持稳定并且拉回(朝近端)，该瓣膜导管留在人体脉管外面，以将人造瓣膜暴露在人体脉管内并且完成瓣膜的展开。
参考图23A，所示的输送套管24在缩回位置，因此人造瓣膜16和拖把状物80的延伸部分150被露出。尽管存在由扩展的人造瓣膜施加在该输送套管24上的压力，但是输送套管24的尖端部分172足够柔软以在瓣膜展开时能够拉回输送套管24。为了使缩回输送套管24更加容易由操作者执行，该输送套管24的内层173(见图9)可以用诸如
Figure S2006800389085D00201
的低摩擦系数材料形成。
参考图23B，在人造瓣膜16的自扩展能力使其向外扩展时球囊18可以缩小。拖把状物80的延伸部分15优选足够柔软，因此在保持与瓣膜16的连接的同时该延伸部分允许瓣膜的扩展。参考图23C，在人造瓣膜16已经开始扩展之后，该球囊18可以再一次膨胀以进一步增大人造瓣膜16的直径。该附加的扩展确保人造瓣膜呈现完全扩展的状态，由此该瓣膜被牢固地安放在自体瓣膜的部位250。在人造瓣膜扩展时在自体瓣膜部位250的小叶256压靠在主动脉的壁上。正如上面所讨论的，球囊18由连接于该球囊导管14的支撑件22的流体轴34的流体源来膨胀(见图2)。停止旋塞35控制流进主轴32和球囊导管14的球囊轴20中的流体的流量(见图2)。Touhy Borst阀36的压缩阀防止流体从球囊导管14(见图2)泄漏。
拖把状物80的延伸部分150向外弯曲，以容纳人造瓣膜16的扩展。如图23B和23C所示在人造瓣膜16膨胀时，通过推进或拉回该输送系统10的瓣膜导管23，操作者可以调节人造瓣膜的位置。拖把状物80的延伸部分150具有足够的刚度以使人造瓣膜16的位置能够用最小的控制量被操纵。在瓣膜扩展之前，瓣膜定位的控制由操作者推、拉或扭转该瓣膜导管23来实现。瓣膜导管23和球囊导管14之间的连接使该瓣膜导管23的移动能够从该瓣膜导管23传递给球囊导管14。
参考图23D，应当理解，在瓣膜展开期间，瓣膜导管23和输送套管24之间的相对运动能够通过反转旋转器旋钮572(或展开旋钮620)的方向，或通过在保持内导管23固定的同时手工推动(朝远端)近端套筒26而被反向。在一个有利的特征中，在瓣膜初始展开之后如果瓣膜的位置和/或方位不是所希望的，则输送套管可以相对于瓣膜导管移动(即，前进)以减小瓣膜的直径。更具体地说，当输送套管24的远端162在拖把状物80的延伸部分150上朝远端前进时，该延伸部分150被向里推。由于该延伸部分被向里推，人造瓣膜被皱缩。因此，如果操作者不满意人造瓣膜16的初始展开，则操作者可以皱缩并且重新定向该人造瓣膜16。结果，输送系统可以用来部分地或整个地将人造瓣膜拉回到该输送套管中使得人造瓣膜能够重新展开或完全缩回。
参考图23E，一旦操作者对人造瓣膜16的安放位置满意之后，该人造瓣膜从拖把状物80的延伸部分150分开。为了从瓣膜导管23脱开人造瓣膜16，拉动连接于该结合金属丝234的旋钮236(见图19)。金属丝234的六根单个的金属丝的远端从合缝袋和瓣膜小叶中并且从该缝合线238被拉出，使缝合线238能够离开人造瓣膜16的连接点，因此缝合线238离开人造瓣膜16(见图20)。于是人造瓣膜16与瓣膜导管23脱离。人造瓣膜16的脱离可以在操作者认为合适的任何时候发生，但是通常当延伸部分150已经向外扩展到其最充分的程度时发生。
在释放人造瓣膜16之后，瓣膜导管23和球囊导管14优选地返回到输送套管24的通道168中(见图11)。在包括手柄组件500和608(见图12和图21)的本发明的这些实施例中，为了使瓣膜导管23和球囊导管14返回到输送套管24的通道168中，操作者改变旋转器旋钮572或展开旋钮620的方向。在不采用丝杠的可替换实施例中，在保持输送套管24(见图1)固定的同时，外科医生(朝近端)拉瓣膜导管23和球囊导管14。于是该输送系统10从病人的人体脉管抽回。
虽然本文描述的优选实施例包括可以用作扩张器尖端并且可以用于帮助安放该人造瓣膜的球囊导管，但是应当理解，该系统可以没有该球囊导管而使用。当不提供球囊导管时，人造瓣膜从瓣膜导管释放并且用足够的力自扩展，以牢固地将其自身植入在治疗部位。在这里描述的优选实施例的另一种变型中，该输送系统可以被构造成使得球囊导管和瓣膜导管形成整体单元。
参考图24，在另一个可选实施例中，从输送套管24朝远端伸出的过渡件可以采用机械式吊舱(basket)700的形式，以方便进入人体脉管中并向自体瓣膜部位循迹行进。该机械式吊舱包括被包围在尿烷(urethane)罩704中的支杆(strut)702，该罩在远端固定在导丝轴31上并且在近端固定在吊舱轴705上。该支杆702用激光切割管材形成。该支杆能够被热定型以向外弯曲，并且优选由高级弹性镍钛(Nitinol)形成，以便有效地扩展和皱缩。该人造橡胶罩704提供平滑的圆形的尖端，用于循迹行进通过主动脉。在循迹行进时，吊舱700从输送套管24的远端162伸出。
吊舱轴705通过球囊轴20。球囊18在远端42(见图3A和3B)处被固定在该吊舱轴705上，并且在近端40(见图3A和3B)处被固定在球囊轴20上。该球囊轴20通过输送套管24。
导丝轴31从吊舱轴705朝着远端伸出，并且包括拉线706，该拉线从其被连接的位置导丝轴31的远端处延伸通过吊舱到达输送系统10的近端，其中拉线可以被操作以扩展或皱缩该吊舱700。导丝轴31和吊舱轴705通过该输送系统10并且从该支撑件22(见图2)朝近端伸出。该吊舱轴705从导丝轴31朝近端伸出。当操作者使该吊舱轴705保持固定并且推或拉该导丝轴31时，该导丝轴31和吊舱轴705能够相对于彼此移动。操作者还可以使用该拉线706实现该导丝轴31和吊舱轴705之间的相对运动。当吊舱的远端和近端移动彼此离开或靠近时，这两个轴31和705之间在远端的相对运动使吊舱700的支杆702向里或向外弯曲。
在向自体瓣膜部位循迹行进时，吊舱700从输送套管24的远端162朝着远端伸出。类似于上述的球囊18，吊舱700的形状提供锥形表面，用于容易过渡进入人体脉管中，并且容易循迹行进通过人体脉管到自体瓣膜部位。
在图24所示的可替换实施例中，该导丝轴31和吊舱轴705之间的相对运动用于皱缩和扩张吊舱700的支杆702。尿烷罩704与支杆702一起皱缩。该机械式吊舱700能够被皱缩和扩张，以解除狭窄的小叶或扩张人体脉管的紧缩部分。正如本文其他实施例所讨论的，人造瓣膜16可以放置被在球囊18上和输送套管24中，并且如本文其他实施例所讨论的，瓣膜展开能够类似地进行。
虽然已经以其优选实施例的形式描述了本发明，但是应当理解，已经使用词语是描述性的词语而不是限制性词语。因此，能够在所附权利要求的范围内进行各种修改，而不脱离本发明的真实范围和精神。

Claims (9)

1.一种用于治疗人类心脏中的自体瓣膜的系统，其包括：
人造瓣膜，其包括可扩展框架和瓣状结构；
管状套管，其限定通过其自身的通道；
瓣膜导管，其被构造成可滑动地推进通过所述管状套管的所述通道；
可释放的接合机构，其沿着所述瓣膜导管的远端部分设置，用于接合所述人造瓣膜，所述可释放的接合机构包括多个柔性延伸臂，所述多个柔性延伸臂被构造成在所述人造瓣膜在治疗部位扩展时支撑所述人造瓣膜；
至少一个缝合线，用于将所述人造瓣膜固定于所述柔性延伸臂；和
致动机构，其沿着所述瓣膜导管的近端部分设置，用于使所述可释放的接合机构释放所述人造瓣膜。
2.如权利要求1所述的系统，进一步包括至少一个可滑动件，该可滑动件连接于所述致动机构并且朝着所述人造瓣膜远端地延伸，其中所述可滑动件是可缩回的，用于从所述人造瓣膜上拆开所述缝合线，因而从所述柔性延伸臂释放所述人造瓣膜。
3.如权利要求1所述的系统，进一步包括可扩展的过渡件，该过渡件从所述管状套管的远端延伸。
4.如权利要求3所述的系统，其中所述过渡件包括具有锥形远端部分的可膨胀球囊。
5.如权利要求4所述的系统，其中所述可膨胀球囊至少部分地设置在所述人造瓣膜内，并且其中所述可膨胀球囊的膨胀有助于所述人造瓣膜的扩展。
6.如权利要求5所述的系统，其中所述人造瓣膜的所述可扩展框架是可球囊扩展的。
7.如权利要求1所述的系统，其中所述人造瓣膜的所述可扩展框架是自扩展的。
8.如权利要求3所述的系统，其中所述过渡件包括可扩展的机械式吊舱。
9.如权利要求1所述的系统，进一步包括手柄组件，该手柄组件具有连接于所述管状套管的远端部分和连接于所述瓣膜导管的近端部分，所述手柄组件可调节用于以可控制的方式相对于所述瓣膜导管缩回所述管状套管。
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CA2624635C (en) 2014-06-10
CA2847685A1 (en) 2007-04-26
US20070088431A1 (en) 2007-04-19
US20200237504A1 (en) 2020-07-30
ATE502604T1 (de) 2011-04-15
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US10624739B2 (en) 2020-04-21
WO2007047488A3 (en) 2007-09-20
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US20120290078A1 (en) 2012-11-15
JP4989655B2 (ja) 2012-08-01
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US20170056161A1 (en) 2017-03-02
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US9839514B2 (en) 2017-12-12
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