CN104188737B - 用于替换二尖瓣的人工瓣膜 - Google Patents
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- A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
- A61F2/02—Prostheses implantable into the body
- A61F2/24—Heart valves ; Vascular valves, e.g. venous valves; Heart implants, e.g. passive devices for improving the function of the native valve or the heart muscle; Transmyocardial revascularisation [TMR] devices; Valves implantable in the body
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- A—HUMAN NECESSITIES
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- 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
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- A—HUMAN NECESSITIES
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- A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
- A61F2/02—Prostheses implantable into the body
- A61F2/24—Heart valves ; Vascular valves, e.g. venous valves; Heart implants, e.g. passive devices for improving the function of the native valve or the heart muscle; Transmyocardial revascularisation [TMR] devices; Valves implantable in the body
- A61F2/2409—Support rings therefor, e.g. for connecting valves to tissue
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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
- 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
- A61F2/2442—Annuloplasty rings or inserts for correcting the valve shape; Implants for improving the function of a native heart valve
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Abstract
提供了用于植入天然二尖瓣内的人工瓣膜的实施方式。人工瓣膜的优选实施方式包括可径向压缩的主体和单向瓣膜部分。人工瓣膜进一步包括与主体相连接并位于主体外部的至少一个心室锚定件。在主体的外表面和心室锚定件之间提供空间,用于接收天然二尖瓣小叶。人工瓣膜优选包括适于放置在二尖瓣环上的心房密封件。也描述了用于递送和植入人工瓣膜的方法和设备。
Description
本申请是申请日为2010年12月3日、名称为:“用于替换二尖瓣的人工瓣膜”的中国专利申请201080054904.2的分案申请。
技术领域
本公开一般地涉及用于修复和/或替换天然心脏瓣膜的假体装置,并且特别地涉及用于替换有缺陷二尖瓣的人工瓣膜,以及用于在人心脏内递送和植入该人工瓣膜的方法和设备。
背景技术
已经使用人工瓣膜很多年治疗心脏瓣膜病。天然心脏瓣膜(即,主动脉瓣、肺动脉瓣、三尖瓣和二尖瓣)在确保充足血液供应通过心血管系统向前流动中起关键作用。先天畸形、炎症过程、传染病症或疾病可使这些心脏瓣膜变得不太有效。对瓣膜的这种损害可导致严重的心血管危害或死亡。多年以来,对于这种病的确定性治疗是在开心外科期间手术修复或替换瓣膜。然而,这样的手术是高侵入性的,并且易于产生很多并发症。因此,具有缺陷心脏瓣膜的上年纪的和虚弱的患者通常不被治疗。最近,已经研发了利用软导管,以比开心外科的侵入性小得多的方式引入和植入人工心脏瓣膜的经血管技术。
在该技术中,人工瓣膜以蜷曲状态安装到软导管的末端部分上,并通过患者的血管前进,直到瓣膜到达植入位置。导管末梢处的瓣膜随后在有缺陷的天然瓣膜处,例如通过使其上安装有瓣膜的球囊充气而被膨胀至其功能尺寸。
用于植入人工主动脉瓣的另一已知技术是切顶进路,其中在患者的胸壁上形成小切口,并且导管通过心尖(即,底末梢)前进。切顶技术在美国专利申请公布号2007/0112422中公开,其因而通过引用并入。与经血管进路类似,切顶进路可包括具有操纵机构(steering mechanism)的球囊导管,用于通过导引器递送球囊-可膨胀的人工心脏瓣膜至主动脉环。球囊导管可包括正好接近远端球囊的偏转部分,以便于在主动脉环内以合适方位放置人工心脏瓣膜。
以上技术和其他技术已经为患有主动脉瓣疾病的高手术风险患者提供了很多选择,以避免开心外科和心肺分流术的结果。虽然针对主动脉瓣的装置和方法被很好地开发,但由于主动脉瓣和二尖瓣之间明显的差异,这样的基于导管的方法不一定适用于二尖瓣。二尖瓣具有复杂的瓣膜下器官(apparatus)即腱索,其在主动脉瓣中不存在。
由于手术二尖瓣修复技术(例如,二尖瓣瓣膜成形术)的高成功率和修复后注意到的临床改善,其普及性已经增加。除了现有的二尖瓣修复技术之外,还有很多旨在以较少侵入性的方法使二尖瓣得以修复的新技术。这些技术的范围从Alfieri缝合手术的重复(iterations of the Alfieri stitch procedure)至对瓣膜下褶或心室改造装置的基于冠状窦的二尖瓣解剖结构的改变,其将附带地纠正二尖瓣回流。
然而,对于二尖瓣替换,可用的有较小侵入性的选择很少。在美国每年有大约25,000例二尖瓣替换(MVR)。然而,估计超过300,000个达到治疗准则的患者基于他们的年龄和/或并存病被拒绝治疗。因此,存在用于替换二尖瓣的最小侵入性技术的需要。
发明内容
在此描述了人工二尖瓣、其部件及其植入方法和装置。
描述了假体装置,其被配置用于在心脏的天然二尖瓣区域植入,并且包括主体,该主体可径向压缩至径向压缩状态并可从压缩状态自膨胀至径向膨胀状态。假体装置也包括至少一个与主体相连接并位于主体外部的心室锚定件(ventricular anchor),以便当主体被压缩至压缩状态时,在心室锚定件和主体外表面之间的小叶-接收空间增加,以在其间接收天然瓣膜小叶。当主体在主体或心室锚定件上不存在任何实质的外部向内力的情况下自膨胀至膨胀状态时,空间减小,以抓住在主体和心室锚定件之间的小叶。
在一些实施方式中,用于在心脏天然二尖瓣区域上植入的假体装置包括具有主体和至少一个被连接至主体并位于主体外部的心室锚定件的框架。假体装置也包括多个由主体支撑的小叶,其形成用于血液流动通过主体的单向瓣膜。主体可径向压缩至径向压缩状态以便递送入身体,并可从压缩状态自膨胀至径向膨胀状态。心室锚定件包括稳定地固定至主体的基底,与基底相对的自由末端部分,和限定在心室锚定件和主体之间、用于接收天然瓣膜小叶的小叶-接收空间的中间部分。在心室锚定件上不存在任何径向向内力的情况下,主体从其压缩状态膨胀至其径向膨胀状态使小叶-接收空间减小。
在其他实施方式中,用于在天然二尖瓣区域上植入的假体装置包括主体、至少一个心室锚定件和至少一个心房锚定件。主体被配置用于放置在天然二尖瓣内,并且主体可压缩至径向压缩状态以便递送入心脏,并可从压缩状态自膨胀至膨胀状态。至少一个心室锚定件被连接至主体并位于主体外部,以便在膨胀状态中,小叶-接收空间存在于心室锚定件和主体外表面之间,以接收天然瓣膜小叶的自由边缘部分。心室锚定件包括接合部分,其被配置以在接收的天然小叶后延伸并接触天然二尖瓣环的心室表面、接收的天然小叶的环连接部分、或天然环的心室表面和接收的天然小叶的环连接部分两者。至少一个心房密封件被连接至主体并位于主体外部,并被配置为在与心室锚定件的接合部分相对的位置处,接触天然二尖瓣环的心房部分、接收的天然小叶的环连接部分、或天然环的心房表面和接收的天然小叶的环连接部分两者,以保持假体装置和/或防止瓣周漏。
也描述了用于递送假体装置进入心脏的示例性递送系统。一些实施方式包括具有远端部分的内鞘,该远端部分具有至少一个从内鞘远端向近端延伸的纵向槽。内鞘的远端部分被配置为容纳处于径向压缩状态的假体装置。外鞘同轴地位于内鞘周围,并且内鞘和外鞘中的至少一个在第一位置和第二位置之间相对于另一个是轴向可移动的,在第一位置中外鞘延伸至纵向槽的至少一部分上,在第二位置中纵向槽的至少一部分未被外鞘覆盖,以使容纳在内鞘内的假体装置的一部分通过槽向外径向膨胀。
也描述了用于在心脏的天然二尖瓣区域上植入假体装置的示例性方法。一种这样的方法包括以径向压缩状态递送假体装置进入心脏;使心室锚定件自膨胀远离框架主体,而主体被保持在压缩状态,由此增加心室锚定件和主体外表面之间的间隔;放置主体在天然二尖瓣环中和心室锚定件邻近天然二尖瓣小叶的心室侧,以便小叶位于心室锚定件和主体的外表面之间的间隔中;并且使主体自膨胀至膨胀状态,以便间隔减小,以抓住在主体外表面和心室锚定件之间的小叶。
附图说明
图1是人心脏的横截面视图。
图2是人心脏的另一个横截面视图,其显示了二尖瓣区域。
图3是天然二尖瓣解剖结构的示意图,其显示了经由腱索附接至乳头肌的二尖瓣小叶。
图4A是天然二尖瓣的图,其显示了Carpentier命名。
图4B显示了在小叶之间具有间隔的天然二尖瓣。
图4C和4D显示了位于天然二尖瓣内的示例性人工瓣膜。
图5是人工瓣膜的示例性实施方式的侧视图。
图6显示了相对于瓣膜纵轴旋转90度的图5的人工瓣膜。
图7是图5示出的人工瓣膜的心室(流出)视图。
图8-10是对应于图5-7的视图,其显示了图5-7的人工瓣膜框架的示例性实施方式。
图11-16是不含心房密封件的图9框架的一系列侧视图,其显示了当主体被径向压缩时,在心室锚定件和主体之间的小叶-接收空间增加。
图17-22是分别对应于图11-16的一系列端视图。
图23是心脏的横截面视图,其显示了植入二尖瓣区域中的图9的框架,其中天然二尖瓣小叶在主体和心室锚定件之间被抓住。
图24显示了图9的心房密封件、主体和心室锚定件的示例性尺寸。
图25显示了不包括心房密封件的框架的示例性实施方式,其包括从主体的心室端向下延伸的“T”形推动构件。
图26显示了不包括心房密封件的框架的示例性实施方式,其包括从主体的心室端向下延伸的“V”形推动构件。
图27-29显示了具有含有四个心室锚定件的框架的人工瓣膜的示例性实施方式。
图30-32显示了在图27-29中示出的人工瓣膜的框架。
图33是心脏的横截面视图,其显示了植入二尖瓣区域中的图30-32的框架。
图34是心脏的横截面视图,其显示了包括延伸的心室锚定件和心房密封件的框架的实施方式,其被植入二尖瓣区域,以便二尖瓣环和/或天然小叶被压缩在延伸的心室锚定件末端和心房密封件之间。
图35和36是包括“S”形心室锚定件的框架的示例性实施方式的侧视图。
图37和38分别是不包括心房密封件、包括较宽形状的心室锚定件的框架的示例性实施方式的侧视图和俯视图。
图39是心脏的横截面视图,其显示了植入二尖瓣区域中的框架的实施方式,其中心室锚定件在膨胀后保持与框架体分离,并且心室锚定件接触二尖瓣小叶的下端,以利用来自腱索的张力保持框架。
图40显示了包括基本上扁平的心房密封件的框架的示例性实施方式。
图41显示了包括向上延伸心房密封件的框架的示例性实施方式。
图42显示了包括向上延伸心房密封件和延伸的心室锚定件的框架的示例性实施方式。
图43显示了不包括心房密封件、包括宽设置(wide-set)的心室锚定件的框架的示例性实施方式。
图44描述了不包括心房密封件、具有弹开(flip up)成最终构造的心室锚定件的框架示例性实施方式的一系列侧视图。
图45描述了不包括心房密封件、具有卷起成最终构造的心室锚定件的框架示例性实施方式的一系列侧视图。
图46A-46C显示了不包括心房密封件的框架的示例性实施方式,其中主体与心室锚定件分开制造。
图47A-47D显示了不包括心房密封件的框架的另一个实施方式,其中主体与心室锚定件分开制造并用套筒进行附接。
图48A-48C显示了不包括心房密封件的框架的另一个实施方式,其中主体与心室锚定件分开制造,并用具有机械锁的套筒进行附接。
图49显示了用于在心脏的天然二尖瓣区域上递送和植入人工瓣膜的递送系统的示例性实施方式。
图50是图49的递送系统远端部分的详细视图。
图51是图49的递送系统的手柄部分的沿截面线51-51的横截面视图。
图52是图49的递送系统的手柄部分的沿截面线52-52的横截面视图。
图53是图49的递送系统的可插入部分的沿截面线53-53的横截面视图。
图54显示了图49的递送系统,其中人工瓣膜被装入有槽内鞘内,心室锚定件通过内鞘的槽向外延伸。
图55是在内鞘和外鞘内以及在推动器杆的鼻锥体和末梢之间包含人工瓣膜的递送位置中图49的递送系统的横截面视图。
图56是图49的递送系统的远端部分的横截面视图,其显示了缩回的递送系统的外鞘,以便心室锚定件通过内鞘的槽向外延伸。
图57是心脏的横截面视图,其显示了利用图49的递送系统,在左心室中正在预展开的人工瓣膜的心室锚定件。
图58是左心室的心脏二尖瓣区域的视图,其显示了在递送系统中从槽延伸的心室锚定件,并显示了位于各二尖瓣小叶和心室壁之间的心室锚定件。
图59是心脏的横截面视图,其显示了利用图49的递送系统,正被植入二尖瓣区域中的人工瓣膜,天然小叶位于心室锚定件和内鞘之间。
图60是图49的递送系统的横截面视图,其显示了有槽内鞘缩回至人工瓣膜的心室锚定件接触有槽内鞘周围有凹口的保留带的点。
图61是图49的递送系统的横截面视图,其显示了在带已经破碎后有槽内鞘完全缩回,和在从鞘处完全被展开后,人工瓣膜处于膨胀状态。
图62是左心室的心脏二尖瓣区域的视图,其显示了完全植入的人工瓣膜的示例性实施方式,其中二尖瓣小叶被抓住在主体和心室锚定件之间。
图63显示了根据另一个实施方式,在用于递送至心脏的天然瓣膜区域的导管鞘内的人工瓣膜的示例性实施方式。
图64显示了图63的人工瓣膜,其中导管鞘被拉回,以便心室锚定件自由膨胀,但主体保持压缩。
图65显示了图63的人工瓣膜,其中外鞘重新抓住(recapture)主体,以便仅心室锚定件是暴露的。
图66是心脏的横截面视图,其显示了利用经心房进路,正被植入天然二尖瓣区域中的图65的人工瓣膜。
图67是心脏的横截面视图,其显示了利用经中隔(transeptal)进路,正被植入天然二尖瓣区域中的图65的人工瓣膜。
图68是左心室的二尖瓣区域的视图,其显示了通过心房递送的人工瓣膜的实施方式,其中心室锚定件无鞘(free of a sheath)延伸并位于天然二尖瓣小叶和心室壁之间。
图69是左心室的二尖瓣区域的视图,其显示了图68的人工瓣膜完全膨胀并固定至天然二尖瓣小叶。
图70是心脏的横截面视图,其显示了被固定至二尖瓣区域的天然组织的对接框架(docking frame)和被固定至对接框架的对接框架腔内的分别展开的人工瓣膜的实施方式。
图71是用于植入天然二尖瓣区域中以治疗二尖瓣回流的假体装置的实施方式的透视图。
图72是图71的假体装置的侧视图。
图73是图71的假体装置的另一个侧视图。
图74是图71的假体装置的端视图。
图75-79是心脏的横截面视图,其显示了图71的假体装置的经中隔递送。
图80是包括人工瓣膜的图71的假体装置的可选实施方式的侧视图。
图81是包括Z-切口框架体的图71的假体装置的可选实施方式的部分侧视图。
图82是包括格式框架体和人工瓣膜的图71的假体装置的可选实施方式的部分侧视图。
图83是包括螺旋框架体的图71的假体装置的可选实施方式的部分侧视图。
图84和85显示了用于植入具有“L”形心室锚定件的示例性假体装置的示例性方法。
图86和87显示了用于植入具有“L”形心室锚定件的另一个假体装置的另一个示例性方法。
图88是天然二尖瓣区域的心室视图。
发明详述
在此描述的是主要意欲被植入在人心脏的二尖瓣区域上的人工瓣膜和其部件及其植入装置和方法的实施方式。该人工瓣膜可用于帮助恢复和/或代替有缺陷的天然瓣膜的功能性。
人心脏
人心脏的相关部分在图1和2中示出。健康的心脏具有逐步变细至下尖端(下顶,lower apex)38的大体上圆锥形的形状。心脏是四个室的,并包括左心房4、右心房26、左心室6和右心室28。心脏的左右侧由通常被称为隔膜30的壁分开。人心脏的天然二尖瓣2将左心房4连接至左心室6。与其他天然心脏瓣膜例如主动脉瓣14相比,二尖瓣2具有非常不同的解剖结构。
二尖瓣2包括环部分8,环部分8是围绕二尖瓣孔的天然瓣膜组织的环形部分;和一对尖突,或小叶10,12,其从环8向下延伸入左心室6。二尖瓣环8可形成“D”形、椭圆形、或其他具有长短轴的不圆的横截面形状。前小叶10可大于后小叶12,如图4A中示意性示出的,当它们闭合在一起时,在小叶的邻接自由边缘之间形成大体上“C”形的分界线。图4B显示了在小叶10,12之间具有微小间隔3的天然二尖瓣2,例如不能完全闭合的有缺陷的天然二尖瓣,其可导致二尖瓣回流和/或其他不期望的状况。
当恰当工作时,前小叶10和后小叶12一起起到单向瓣膜的作用,以使血液仅从左心房4流动至左心室6。左心房4接收来自肺静脉32的充氧血液。当左心房4的肌肉收缩并且左心室扩张时,在左心房4中收集的充氧血液流入左心室6。当左心房4的肌肉放松并且左心室6的肌肉收缩时,左心室中增加的血压促使两个小叶在一起,由此闭合单向二尖瓣,以便血液不能流回至左心房,而是通过主动脉瓣14被推出左心室。
为了防止两个小叶10,12在压力下脱垂和通过二尖瓣环8朝向左心房4对折,多个被称为腱索16的纤维索(fibrous cord)将小叶10,12拴在左心室6中的乳头肌上。参考图3和4,腱索16被附接至后内乳头肌22和前小叶10和后小叶12(分别为A1和P1区域,如Carpentier命名所确定的)的后内边缘之间,并在其间延伸。类似地,腱索16被附接至前侧乳头肌24和前小叶10和后小叶12(分别A3和P3区域,如Carpentier命名所确定的)的前外侧边缘之间,并在其间延伸。A2和P2区域相对无腱索附接点,并提供了人工二尖瓣可被固定的区域(见图3)。另外,腱索的组织提供了以最小的腱索缠结风险递送人工二尖瓣的进路途径(approach path)。
人工瓣膜
当天然二尖瓣不能恰当起作用时,人工瓣膜替换可帮助恢复恰当的功能性。然而,与具有相对圆和牢固环的主动脉瓣14相比(特别是主动脉狭窄的情况下),二尖瓣环8相对不太牢固并且更不稳定。因此,不可能通过仅仅依靠来自人工瓣膜外表面挤压天然二尖瓣环8的径向力的摩擦,将主要为主动脉瓣设计的人工瓣膜固定在天然二尖瓣环8内。因此,代替径向摩擦力或除径向摩擦力之外,在此描述的人工瓣膜还可依靠心室锚定件,以将人工瓣膜固定在天然二尖瓣环8内(例如,见图23)。
除了提供用于人工瓣膜的固定手段,心室锚定件也可改造左心室6,以帮助治疗二尖瓣回流的根本起因——左心室扩大/扩张。心室锚定件可拉动天然二尖瓣小叶10,12更加靠近在一起,并且朝向左心房,并经由腱索16,由此拉动乳头肌22,24更加靠近在一起,其可明显地正向改造心室并防止左心室进一步扩大。因此,心室锚定件也可被称为张紧构件或整形构件(reshaping member)。
图5-7图解了根据一个实施方式的可被植入心脏的天然二尖瓣区域中以替换天然二尖瓣2的功能性的示例性人工瓣膜100。人工瓣膜100包括框架102和由框架支撑和/或在框架内的瓣膜结构104。瓣膜结构104可包括多个假体小叶106(在图解的实施方式中为三个)和/或其他部件,用于调控血液在一个方向上流动通过人工瓣膜100。例如,在图5和6中,瓣膜结构104在框架102内定向,以便瓣膜结构的上端110是流入端,并且瓣膜结构的下端112是流出端。瓣膜结构104可包括多种合适材料的任一种,例如自然组织(例如,牛心包组织)或合成材料。利用合适的技术和机构,可将瓣膜结构104安装到框架102上。例如,在图解的实施方式中,小叶106以三尖布置缝合到框架102上,如图7所示。
例如,在在此通过引用并入的美国专利申请公布2009/0276040A1号和美国专利申请12/393,010号中,描述了关于人工瓣膜的部件和组件的额外细节(包括用于将小叶安装到框架上的技术)。
如图8-10所示,框架102可包括管形主体122,从主体的心室端130延伸的一个或多个心室锚定件126,和任选地,从主体的心房端132向外径向延伸的心房密封件124。当框架102被植入心脏的天然二尖瓣区域中时,如图23所示,主体122位于天然二尖瓣环8内,主体122的心室端130为下出口末端,主体132的心房端132为上入口末端,心室锚定件126位于左心室6中,并且心房密封件124位于左心房4中。
框架102可由金属丝网制成,并且在径向膨胀状态和径向压缩状态之间可为径向可折叠的和可膨胀的(如在图11-16和17-22中以一系列连续阶段示意性显示的),以使在心脏二尖瓣区域上(或在另一个天然心脏瓣膜内)的递送和植入得以实现。图11-22中示出的框架102的实施方式不包括心房密封件124,尽管框架102的其他实施方式确实包括心房密封件124。金属丝网可包括布置成格子图案的金属丝或支杆,例如图8-10中示出的锯齿形或Z字形图案,但也可使用其他图案。框架102可包括形状记忆材料,例如镍钛诺,以使从径向压缩状态自膨胀至膨胀状态得以实现。在可选实施方式中,通过膨胀装置例如可充气球囊(未示出),框架102可从径向压缩状态塑性可膨胀至膨胀状态。这样的塑性膨胀框架可包括不锈钢、铬合金和/或其他合适的材料。
在膨胀状态下,如图8-10所示,框架102的主体122可形成开口端管。瓣膜结构104可例如经由框架内表面上的材料层142与框架102的内表面相连接,如以下所讨论的,并可被保持在由主体122形成的腔内,如图7所示。主体122的外表面可具有类似于二尖瓣孔即二尖瓣环8内表面的尺寸,但不是必须的。在一些实施方式中,例如,主体122的外表面可具有小于天然二尖瓣孔直径尺寸的直径尺寸,以便主体122可以以膨胀状态安装在二尖瓣孔内,而基本上不拉伸天然二尖瓣环8,例如在图23中。在这样的实施方式中,框架102不必依靠在主体122的外表面和二尖瓣环8的内表面之间的压力配合(pressure fit),或摩擦配合(friction fit),进行人工瓣膜保持。相反地,框架102可依靠心室锚定件126和/或心房密封件124进行保持,如以下进一步所描述的。然而,在其他实施方式中,主体122可被配置以膨胀至与天然二尖瓣孔相等或比天然二尖瓣孔更大的尺寸,并由此当被植入时产生压力配合。
在其中主体122包括直径尺寸小于天然二尖瓣孔直径尺寸的实施方式中,主体可在天然小叶10,12之间松散定位,或“浮动”。如图4C所示,该松散安装可在小叶10,12和框架的主体122之间产生间隔37。为了防止血液在人工瓣膜100的外部和天然瓣膜组织之间,例如通过间隔37流动,环形心房密封件124可与二尖瓣环8心房侧上的天然组织形成完全环形的接触区域或密封。因此,如图4D所示,心房密封件124的大小可适合完全覆盖间隔37。
框架102的末端可具有锯齿形或Z字形图案,如图8-10所示,其包括一系列并排的“V”形部分,该“V”形部分例如以它们的上端连接在一起。该图案可便于压缩,并可帮助最大化框架通过其连接至天然组织的表面积。可选地,框架102的末端可具有笔直的边缘,或一些其他图案。
在一些实施方式中,主体122可包括至少一个从主体122的心室端130向下延伸的延伸构件或推动构件。例如,图25中示出的框架202,包括从主体222“V”形部分之一的下顶点延伸的叉头(prong)204形式的延伸构件。叉头204可具有包括下推动表面206的倒置“T”形。在另一个实施方式中,图26中示出的框架302包括从主体322的两个邻近的下顶点延伸的“V”形推动构件304,并包括推动表面306。推动表面206和306可分别包括框架202和302上的最低点,并可提供推动表面,用于将框架推出递送装置,而不接触心室锚定件226,326,如以下更加详细描述的。
再次参考图8-10中示出的实施方式,框架102的心房密封件124可与主体122一体,并可由与主体122相同的金属丝网格组成,以便心房密封件124也可径向可折叠和可膨胀。在膨胀状态下,心房密封件124可为大体截头锥(锥台,frustoconical)的,并从主体122的心房端132同时径向向外和轴向向下朝向主体122的心室端130延伸。心房密封件124的外缘140的大小和形状可适合于当框架102被植入时接触二尖瓣环的心房侧和左心房8的组织,如图23所示。外缘140的端视图轮廓——如图10所示,可具有大体上圆形、椭圆形或大体上对应于心房壁18和二尖瓣环8的天然几何形状的其他形状。使用框架,在心房密封件124和心房壁18和/或二尖瓣环8的组织之间的接触可促进组织向内生长,这可改善保持和减少瓣周漏。
心房密封件124期望被设定大小,以便当人工瓣膜100被植入天然二尖瓣中时,如图23所示,外缘140接触整个天然瓣膜周围的天然环8,并因此完全覆盖天然小叶10,12之间的开口。心房密封件124期望包括对血液流动不可渗透的密封层142。以这种方式,心房密封件124能阻止血液流回进入在人工瓣膜100的外表面和天然瓣膜组织之间的左心房。心房密封件也确保当血液从左心房流至左心室时,所有或基本上所有血液通过单向瓣膜。
如图5-7所示,至少一个生物相容片或层142可与主体122和心房密封件124的内和/或外表面相连接,以形成至少一个覆盖金属丝网上开口的层或包封。层142可通过例如缝线与框架102相连接。层142可形成可至少部分阻止血液流动通过金属丝网的流体阻塞和/或密封构件,以减少瓣周漏,并可利用框架102促进组织向内生长。层142可提供安装表面或支架,部分瓣膜结构104例如小叶106可被固定至其上。例如,图5和6中的虚线108表示小叶106的入口端可被缝制、缝合或以其他方式固定到层142的位置。在小叶106的入口端和层142之间的该缝制可形成密封件,该密封件在层142的内周长周围是连续的,并可阻止血液在层142的内表面和小叶106的外表面之间流动。该密封件可使人工瓣膜100引导血液在多个小叶106之间流动。
相同层142和/或一个或多个单独的翻边(cuff)144也可包裹或覆盖框架102的末端边缘,例如主体122的心室端130和/或心房密封件124的外缘140。这样的翻边144可覆盖和保护在框架102的末端处的尖锐边缘。例如,在图5示出的实施方式中,层142从外缘140跨过心房密封件124的上表面并向下沿主体122的内表面延伸,并包括包裹并覆盖主体122的心室端部分的翻边144。层142可被缝合到外缘140和主体122的内表面上。
层142可包括阻止血液流动但可允许组织向内生长的半多孔织物。层142可包括合成材料,例如聚酯材料或生物相容性聚合物。聚酯材料的一个例子为聚对苯二甲酸乙二酯(PET)。可使用可选材料。例如,层可包括生物物质,例如天然组织、心包组织(例如,牛、猪或马心包)或其他生物组织。
参考图8和9,一个或多个心室锚定件126可从框架102的主体122,例如从主体的心室端130延伸。心室锚定件126可起将含有或不含有瓣膜结构104的框架102保持在心脏的天然瓣膜区域内的作用。在图8和9中示出的实施方式中,框架102包括两个在直径上相对的心室锚定件126,当框架102被植入二尖瓣区域中时,所述心室锚定件126可起到将框架102分别固定到前和后二尖瓣小叶10,12上的作用,如图23所示。在可选实施方式中,框架102可具有三个或更多心室锚定件126,所述心室锚定件126可在框架的主体122周围成角度地间隔。
当框架102处于膨胀状态时,如图9,框架的几何形状可促使心室锚定件126紧靠主体122的外表面。可选地,当框架102处于膨胀状态时(例如见图39),心室锚定件126可被配置为与主体122的外表面间隔开。在任何情况下,当框架102被径向压缩至压缩状态时,心室锚定件126和主体122的外表面之间的空间或间隔可增加,如图11-16所示。
当主体122和心房密封件124处于压缩状态时,框架102可被插入二尖瓣孔,以便间隔开的心室锚定件126包裹小叶10,12,并在小叶和心室壁20之间向上延伸(例如见图59)。参考图23,前心室锚定件146可位于前小叶10后,并且后心室锚定件148可位于后小叶12后。参考图3和4,期望两个心室锚定件位于各自的小叶后,接近小叶的中间部分A2,P2,其在两个小叶相遇的连合36之间的中途附近。小叶10,12的这些中间部分A2,P2是期望的心室锚定件位置,因为与更接近连合36的位置相比,腱索16至小叶的附接在这些位置上是较稀少的。
当随后主体122膨胀或使其自膨胀至膨胀状态时,图图11-16所示的以相反次序,心室锚定件被配置以便相对于主体122径向向内枢轴转动,而在心室锚定件上没有外部压缩力。这使心室锚定件126和主体122的外表面之间的间隔减小,由此使抓住在心室锚定件和主体之间的小叶10,12得以实现。相反地,压缩主体122使心室锚定件126枢轴转动远离主体,以增加主体外表面和心室锚定件之间的间隔。在一些实施方式中,当在心室锚定件上无外力情况下径向压缩或膨胀主体122时,心室锚定件126的自由末端或尖端162可基本上保持与另一个距相同的距离。在一些实施方式中,例如图23中示出的实施方式,当框架膨胀至膨胀状态时,框架被配置以压缩在主体和心室锚定件之间的天然二尖瓣小叶10,12。在其他实施方式中,例如图39中示出的实施方式,心室锚定件不向主体压缩或夹住天然小叶,但仍然通过在天然小叶10,12周围钩住心室锚定件,防止人工瓣膜移向左心房。在这样的实施方式中,人工瓣膜100可被保持在适当位置,抵抗通过心房密封件124移向左心室,如以下进一步所描述的。
参考图8-10中示出的实施方式,每个心室锚定件126可包括由例如形状记忆材料例如镍钛诺组成的柔性细长件或金属线150。在一些实施方式中,如图8所示,每个金属线150可包括与主体122的第一附接位置156相连接的第一末端部分152,和与主体第二附接位置158相连接的第二末端部分154。第一和第二末端部分152,154形成心室锚定件的基底。主体的第一和第二附接位置152,154可位于或邻近主体122的心室端130。每根金属线150的两个末端部分152,154可为组成主体122格式网的金属线或支杆的延伸段。每个金属线150进一步包括中间部分160,其在末端部分152,154之间在主体的纵向方向上延伸。中间部分160包括形成心室锚定件的自由末端部分或尖端的弯曲162。
金属线150可具有垂直于金属线长度的圆形或非圆形横截面轮廓,例如多边形横截面轮廓。参考图8A,金属线150可包括具有长度“L”和相对较窄的宽度“W”的矩形横截面形状,以便当附接至框架102的心室锚定件126的两个末端部分152,154朝向彼此移动时,例如当框架被压缩时,金属线150主要在宽度方向上弯曲。这促进心室锚定件126在径向向外远离主体122的方向上弯曲,这加宽心室锚定件126和主体122之间的间隔。该特征可在植入期间帮助抓住在心室锚定件126和主体122之间的小叶。
心室锚定件可包括多种形状或构造。一些框架实施方式,例如图8中示出的框架102,包括在两个附接位置156,158处连接至主体122的大体上“U”或“V”形的心室锚定件126。心室锚定件126的上尖端162可起楔的作用,以便于在各自的小叶后移动心室锚定件,同时将腱索缠结的危险最小化。每个金属线150的末端部分152,154可在主体122的心室端130处分别从附接位置156,158向下延伸。金属线150可随后从每个末端部分152,154朝向尖端162向上弯回。
金属线150可由生物相容性材料覆盖,例如图5-7中示出的实施方式中。第一材料164可包裹或涂布在金属线150的至少一些部分上。第二材料166可跨越金属线150的两个部分,以形成可改善组织向内生长的网状结构。第一和第二材料164,166可例如包括相同材料或不同的材料,例如生物相容的半多孔织物。覆盖材料164,166可利用心室锚定件126增加组织向内生长,以改善保持。此外,覆盖材料可减小心室锚定件126的摩擦性质,以便于植入;和/或增加心室锚定件的摩擦性质,以改善保持。
图24显示了图9中示出的框架102的实施方式的示例性尺寸。心房密封件124外缘140的直径“Dmax”的范围可在大约50mm至大约70mm,并且在一个例子中为大约50mm。主体122的外表面的直径“Dbody”的范围可在大约23mm至大约50mm,并且在一个例子中为大约29mm。一个心室锚定件126的两个附接点156,158之间的距离“W1”的范围可在大约8mm至大约50mm,并且在一个例子中为大约25mm。框架102的总体轴向高度“Hmax”的范围可在大约20mm至大约40mm,并且在一个例子中为大约30mm。从外缘140至心室锚定件126的最低部分168的轴向高度“H1”的范围可在大约10mm至大约40mm,并且在一个例子中为大约23mm。从心室锚定件126的尖端162至心室锚定件126的最低部分168的轴向距离“H2”的范围可在大约10mm至大约40mm,并且在一个例子中为大约18mm。从主体122的下端130至心室锚定件126的最低部分168的轴向距离“H3”的范围可在大约0mm至大约10mm,并且在一个例子中为大约5mm。
一些框架实施方式包括超过两个的心室锚定件。例如,框架可具有两个或更多心室锚定件,所述心室锚定件被配置以附接至沿天然瓣膜的单个小叶的多个位置。在一些这样的实施方式中(未示出),框架可包括两个附接至前二尖瓣小叶10的心室锚定件和/或两个附接至后二尖瓣小叶12的心室锚定件。心室锚定件也可附接至代替A2和P2区域的小叶的其他区域或除A2和P2区域外的小叶的其他区域。
一些人工瓣膜实施方式包括围绕主体均匀间隔开的四个心室锚定件。图27-32显示了一个这样的人工瓣膜实施方式400,其包括框架402,所述框架402包括在主体422的直径上相对侧的一对心室锚定件426和位于心室锚定件426之间大约中途的一对直径上相对的连合锚定件428。心室锚定件426从附接点456和458向下延伸,并包括颈部分450(见图31)。这些心室锚定件426可起类似于框架102的心室锚定件126的作用,以抓住小叶并保持框架402在二尖瓣孔内,如图33所示。连合锚定件428可从主体422上相同的附接位置456,458向上延伸(见图30)。尽管心室锚定件426可分别在A2和P2区域上夹住二尖瓣小叶10,12,但连合锚定件428可钩住二尖瓣连合36周围并在二尖瓣连合36后向上延伸,不压缩小叶。连合锚定件428的尖端464可向上延伸,以邻接二尖瓣环8的心室侧,并压缩在心房密封件424的外缘440和连合锚定件428的尖端464之间的二尖瓣环8。二尖瓣环8的该压缩可提供抵抗心房和心室二者移动的额外保持力。
其他框架实施方式可包括超过四个的心室锚定件。例如,框架可包括六个或更多个可接合小叶10,12和/或连合36上多个位置的心室锚定件。
图34显示了框架实施方式502,其包括延伸的心室锚定件526,所述心室锚定件526被配置以在小叶10,12的末端周围延伸并在小叶后向上延伸至邻近向下延伸的截头锥心房密封件524的外缘540的位置。延伸的心室锚定件526的上尖端562接触二尖瓣环8的心室表面和/或邻近环的天然小叶10,12部分,或小叶的环连接部分,而心房密封件524的外缘540接触二尖瓣环的心房表面和/或小叶的环连接部分。延伸的心室锚定件526和心房密封件524可被配置以彼此相对,并期望压缩二尖瓣环8和/或小叶10,12的环连接部分,以保持框架502不在心房和心室方向上移动。因此,在该实施方式中,心室锚定件526不需要压缩天然小叶10,12紧靠框架主体522的外表面。相反地,如图34所示,小叶10,12可松散地捕获在延伸的心室锚定件526和主体522的外表面之间。
图35和36显示了框架实施方式602,其包括颈状(necked)、“S”形的心室锚定件626。从图35的侧视图来看,心室锚定件626的“S”形状是明显的。从主体622的心室端630上的一个附接点A开始,心室锚定件金属线650从主体向下和径向向外延伸至点B,随后向上和向外弯曲至点C,随后向上和向内弯曲至点D,并随后向上和向外往回弯曲至最高点,或顶点E。心室锚定件金属线650随后按照相似但镜像的途径继续延伸返回至第二附接点。从图36的正视图来看,心室锚定件金属线650形成颈状形状,该颈状形状关于延伸通过主体622中心的纵向中心轴690是对称的,其形成两个镜像半边(halve)。每半个心室锚定件金属线650在主体622的心室端630上的附接点A处开始,向下和向内(朝向另一半)弯曲至点B,随后向上和向内弯曲至在点C的颈状部分,随后向上和向外弯曲(远离另半个)至点D,随后再次向上和向内弯曲至最高点或顶点E,在此两个半边连接在一起。参考图35,主体622的纵向中心轴690至点C和E的径向距离都大于轴690至点D的径向距离。此外,两个点C之间的距离小于两个点D之间的距离。“S”形心室锚定件626可帮助沿金属线650更均匀地分配应力,并且减少某些位置例如附接点A处的应力集中。
图37和38显示了包括两个较宽形状的心室锚定件726的框架实施方式702。每个较宽形状的心室锚定件726包括颈状中间部分780和宽阔的上部分782。上部分782可大体上平行于框架702的流入开口延伸,并可在主体722的外表面周围弯曲。该较宽形状可增加与天然小叶和/或其他心脏组织的表面接触,以减少压力并由此减少磨损。在一些实施方式中,较宽形状的心室锚定件726宽阔上部分782的曲率可对应于主体722的外表面的曲率(见图38),以进一步改善组织接触。较宽形状的心室锚定件可具有与心房密封件接触的较长表面;由此增加保持性能并减少瓣周漏。
图39显示了包括心室锚定件826的框架实施方式802,所述心室锚定件826被配置以甚至在框架802膨胀后限定在锚定件和主体822之间的分开或间隔(尽管锚定件826可另外类似于心室锚定件126起作用,以便当主体压缩和膨胀时,锚定件826和框架主体822之间的间隔可分别增加和减小,以便于在天然小叶后放置锚定件826)。间隔的大小可适合于促进抓住天然小叶10,12,对天然小叶几乎没有压缩或没有压缩。因为几乎没有或没有小叶压缩发生,该框架实施方式802可最小化对天然小叶的损伤。心室锚定件826可分别钩住小叶10,12的心室边缘40,42,同时框架的心房密封件824向下压在二尖瓣环8的心房侧上,而不是压缩小叶10,12进行瓣膜保持。心房密封件824和环8之间的接触使主体822轻微向上移动,向上拉动心室锚定件826紧靠小叶10,12的心室边缘。心室锚定件的向上的力连同来自腱索16小叶上的向下张力抑制植入物朝向左心房4向上移动。
图40显示了框架实施方式902,其包括主体922、心室锚定件926和从主体922的上端932径向向外延伸的盘形心房密封件924。在该实施方式中,心房密封件924基本上垂直于由上端932限定的框架开口延伸,而不是向下朝向框架的下端930延伸。盘形心房密封件924可被放平,穿过二尖瓣环8的上表面,并提供增加的用于组织向内生长的表面积接触。
图41和42分别显示了框架实施方式1002和1012,其包括心房密封件1024,所述心房密封件1024具有从主体1022的上端1032同时径向向外和轴向向上远离主体延伸的大体上截头锥部分1028。心房密封件1024也可包括从与主体1022的上端1032相对的截头锥部分1028进一步向上延伸的大体上圆柱形的上部分或入口部分1029。心房密封件1024可大体上对应于邻近二尖瓣环8的心房壁18的形状,并提供在心房壁组织和心房密封件1024之间的增加的接触面积。框架1002包括心室锚定件1026,其从主体1022的心室端1030并沿着主体的大部分长度延伸。
图42中示出的框架1012包括延伸的心室锚定件1050。延伸的锚定件1050可从主体1022的心室端1030沿主体外表面延伸,并径向向外弯曲以形成沿截头锥部分1028的下表面延伸的上部分1060。该构造可使延伸的心室锚定件1050捕集更多紧靠框架的小叶10,12和/或二尖瓣环8,由此减少瓣周漏并改善组织向内生长和保持。
图43显示了具有心室锚定件1126的框架实施方式1102,与图9中示出的框架102的心室锚定件126相比,所述心室锚定件1126具有较短的力臂D2。较短的力臂D2可在心室锚定件附接点1156,1158上产生减小的转矩。可通过增加在邻近的心室锚定件1126的主体1122上附接点1158和1156之间的距离D1,减少距离D2。框架1102的心室锚定件1126之间的距离D1大于框架102的附接点158和156之间的距离D1(见图9),因此缩短了力F相对于附接点1156的力臂D2。附接点1156和1158上减小的转矩可减少疲劳并因此改善框架1102的耐久性。
心室锚定件的一些实施方式也可任选地包括一个或多个可从心室锚定件径向伸出朝向心室壁20或朝向小叶10,12的倒钩(未示出)。这样的倒钩可帮助保持框架,特别是抵抗朝向左心室6的移动。
图44A-44D图解了框架实施方式1202,其包括“弹开的”心室锚定件1226。每个心室锚定件1226可以为手指状,并可仅从主体1222下端1230上一个附接点延伸。可选地,每个心室锚定件可包括从主体1222上的两个附接点延伸的金属线或类似元件。在图解的实施方式中,心室锚定件1226可被预成形,以便以功能的展开状态沿主体1222的外侧延伸,如图44D所示。在递送期间,心室锚定件1226可被部分或完全弄直,如图44A所示,并通过递送装置例如鞘被保持在该状态。当例如使框架1202从鞘前进时,心室锚定件1226弹回至它们预成形的形状,如图44B-44D所示,抓住心室锚定件1226和主体1222之间的小叶10,12。
图45A-45E表示框架实施方式1302,包括“卷起的”心室锚定件1326。与图44的心室锚定件1226一样,每个心室锚定件1326可以是手指状,并可从主体1322的下端1330上的两个或更多个点延伸。心室锚定件1326可被以弯曲的形状预成形,如图45E所示,其以展开的状态沿主体1322的侧面延伸。在递送期间,心室锚定件1326可被部分或完全地弄直,如图45A所示,并通过递送装置例如鞘保持在该状态。例如使框架1302从鞘前进时,使心室锚定件1326弹回至它们预成形的弯曲的形状,如图45B-45E所示,抓住心室锚定件1326和主体1322之间的小叶10,12。
在一些框架实施方式中,一个或多个心室锚定件部件可与主体分开形成,并随后被组装到一起形成框架。在一个这样的框架实施方式1402中,如图46A-46C所示,主体1422与至少一个心室锚定件部分1424分开形成。心室锚定件部分1424可包括一个或多个从至少部分环形的基底1432延伸的心室锚定件1426,其可包括以它们的上端连接在一起的并排的“V”形支杆部分。在图解的实施方式中,心室锚定件1426的下端在“V”形部分的下顶点上与基底1432相连接。在主体和心室锚定件部分分开形成后,心室锚定件部分1424可被附接至主体1422的下部分1430。例如,基底1432可位于主体1422的外表面的相对侧,并随后被缝制、焊接或以合适的方式另外附接至主体1422的下部分1430,例如通过使用锁定机构。基底1432可被附接至主体1422,以便基底的“V”形部分与主体1422的下端1430的对应“V”形部分重叠。在一些实施方式中,心室锚定件部分1424可包括完整的环,所述完整的环具有从环形基底延伸的所有心室锚定件1426,以便心室锚定件相对于彼此是预间隔开的。环形基底可随后被附接在主体1422的下端1430周围。在其他实施方式中,多个心室锚定件部分1424被固定至主体1422,每个心室锚定件部分1424都具有一个或多个从包括部分环的各自基底1432延伸的心室锚定件1426。
图47A-47D和图48A-48C显示了可选的框架实施方式,其中一个或多个心室锚定件部件与主体分开形成,并随后被组装在一起形成框架。在这些框架实施方式中,主体可包括附接部分,锚定件部分可利用套筒附接至其上。例如,图47A-47D显示了包括主体1502和至少一个心室锚定件1504的示例性框架1500,所述主体1502具有至少两个心室锚定件附接部分1508,所述心室锚定件1504具有用各自的套筒1506连接至各自附接部分1508的两个附接部分1510。类似地,图48A-48C显示了包括主体1602和至少一个心室锚定件1604的示例性框架1600,所述主体1602具有至少两个心室锚定件附接部分1608,所述心室锚定件1604具有用各自的套筒1606连接至各自附接部分1608的两个附接部分1610。套筒可包括例如具有超弹性和/或形状记忆特性的金属材料,例如镍钛诺。在一些实施方式中,套筒可包括适于卷曲过程的退火状态的金属。可通过任何合适的附接手段例如通过焊接,将套筒附接至锚定件部分和主体的附接部分。如图48A-48C所示,锚定件1604的附接部分1610和主体1602的附接部分1608可包括几何特征,例如狭窄区域或切开口(cut-out),其允许套筒1606通过例如形成机械锁将锚定件部分1604整合至主体1602。
框架的多部分构造,如图46-48所示,与单片体(unibody)或整片构造相比,可减少心室锚定件附接位置处的应变和疲劳。相比之下,在一些包括单片体构造的实施方式中,心室锚定件开始被激光切割并膨胀,以便它们从主体下端向下延伸,并随后被形成或弯曲成邻近框架主体外部的期望构造。这样的弯曲可拉紧和削弱弯曲的部分。
为了避免由心室锚定件的塑料变形引起的应变,心室锚定件可以以期望的植入(展开)形状预成形,而不用塑性弯曲心室锚定件。心室锚定件可随后被弹性变形,例如被弄直和/或压缩,以安装入用于通过身体递送至心脏的二尖瓣区域的递送设备。一旦从递送设备的轴向约束释放,变形的心室锚定件可弹性恢复它们预成形的形状,以便于抓住心室锚定件和框架主体之间的小叶10,12。
上述框架的多种实施方式中的任一种都可与流体阻塞构件例如瓣膜结构104相结合,以形成可被植入天然二尖瓣内的完全组装的人工瓣膜。在其他实施方式中,可提供上述框架的任一种,而不用流体阻塞构件,并且可被用作支架或对接结构,以在两阶段递送过程中接收单独的人工瓣膜。参考图70中示出的示例性实施方式,对接框架103(其可具有类似于框架102的构造)可首先通过例如以上讨论的任何固定技术展开。随后,单独的人工瓣膜114可在由先前展开的对接框架103形成的腔内递送并展开。单独的人工瓣膜114期望包括安装流体阻塞构件(图70中未示出)例如具有多个小叶106的瓣膜结构104(见图7)的径向可压缩和可膨胀的框架116。当在对接框架103中膨胀时,人工瓣膜114的框架116接合对接框架103的内侧表面,以便通过例如摩擦或机械锁定零件,保持人工瓣膜114在对接框架103内。可用于这样的两阶段过程中的人工瓣膜的例子在美国专利7,510,575号中公开,在此通过引用并入。在具体实施方式中,人工瓣膜可包括多种经导管心脏瓣膜中的任一种,例如Sapien瓣膜,其从Edwards Lifesciences LLC(Irvine,CA)可得。
抓住心室锚定件和框架主体之间的小叶10,12的技术,例如图23中示出的,可提供几个优势。第一,这可允许固定在天然小叶10,12上,用于保持在二尖瓣区域内。第二,该技术可利用天然腱索16进行保持。第三,当左心室6收缩并且血液通过主动脉瓣冲出(收缩期前向移动)时,该技术可防止前小叶10被“拉动”向主动脉瓣14。第四,该技术倾向于迫使天然小叶10,12在框架主体周围塌缩,其可减少人工瓣膜100外部和天然二尖瓣2之间的渗漏。第五,该技术允许从左心房4或从左心室6的植入,如以下详细描述的。
如上所述,多种框架实施方式可利用一种或多种固定技术,而不是压缩小叶10,12,以保持人工瓣膜100位于二尖瓣孔内的期望位置。这些固定技术可包括,例如,利用天然腱索16的张力,延伸心室锚定件长度,以便心室锚定件的尖端被向上挤靠二尖瓣环8,以形成限位器(stop),并压缩二尖瓣环8和/或心室锚定件的尖端和框架心房密封件的外缘之间的心房组织。
递送方法
对于人工瓣膜100,描述了在下文中描述的用于在天然二尖瓣区域上递送和植入的多种方法和装置,尽管应当理解相似的方法和装置可用于递送和/或植入人工瓣膜100的部件,例如不具有瓣膜结构104的框架102,或其他假体装置。
人工瓣膜100可从左心室6或左心房4被递送至二尖瓣区域。因为天然二尖瓣2的解剖结构,可使用不同的技术和/或设备,这取决于递送人工瓣膜100的方向。
可以以多种方式完成从二尖瓣环8的心室侧的递送。例如,人工瓣膜100可经由切顶进路进行递送,其中经由心脏尖端38进入左心室6,如图57所示。
也可以以多种方式完成从二尖瓣环8的心房侧的递送。例如,可例如利用通过胸部的切口,通过心房壁18进行经心房进路,如图66所示。心房递送也可从肺静脉32进行(见图1)。此外,心房递送可经由经中隔进路进行,如图67所示,其中在隔膜30的心房部分上制成切口,以允许例如经由下腔静脉或上腔静脉34从右心房26进入。
心室进路
一种用于递送压缩的假体装置例如人工瓣膜100至二尖瓣区域的技术包括从左心室6进入天然二尖瓣区域,一个例子为切顶进路。可选地,可通过主动脉瓣14进入左心室6。在切顶进路中,可通过胸部上的切口和心脏尖端38上的切口进入左心室6,如图57所示。切顶递送系统可与切顶进路一起使用。
图49-53显示了被配置以递送和植入人工瓣膜100的示例性切顶递送系统或递送工具2000。递送系统2000可包括一系列绕中心轴排列的同心轴和鞘,并且相对于彼此在轴向方向上可滑动。递送系统2000可包括近端手柄部分2002,用于身体外部的医生操作,而远端部分或插入部分2004被插入身体。
递送系统2000可包括延伸递送系统长度的内杆2006,并包括导线(未示出)可穿过的腔2008。内杆2006可位于推动器杆2010的腔内,并可具有向近端延伸超出推动器杆的近端和向远端延伸超出推动器杆的远端的长度。递送系统2000可包括在内杆2006的外表面和推动器杆2010的内表面之间的环形空间2012。该环形空间可用于充满(flushing with)盐水或用于使血液从远端排出。
递送系统2000进一步包括内鞘2014,其同轴地位于推动器杆2010的至少一个远端部分周围。内鞘2014相对于推动器杆2010在递送位置(见图55)和缩回位置(见图50)之间可轴向滑动。在递送位置上,内鞘2014的远端部分2016位于远离推动器杆2010的远端或推动器末梢2018的位置处。在递送位置上,内鞘2014的远端部分2016形成可包含压缩人工瓣膜100的内腔。在缩回位置上(见图50),内鞘2014的远端2017位于接近推动器末梢2018或在轴向上与推动器末梢2018对齐的位置处。当内鞘2014从递送位置朝向缩回位置移动(通过相对于推动器杆2010向近端缩回内鞘2014或相对于内鞘向远端推进推动器杆)时,推动器末梢2018可迫使人工瓣膜100离开内鞘的远端部分2016。
如图50所示,内鞘2014包括一个或多个从内鞘的远端2017向近端延伸的纵向放置的槽2028。这些槽2028可使包含在内鞘2014内的人工瓣膜100的心室锚定件126从压缩的人工瓣膜主体径向向外延伸,同时主体以压缩状态保持在内鞘内。在图50中示出的实施方式中,两个槽2028被示出定向为在内鞘2014的纵向中心轴的直径上相对侧。该实施方式对应于包括两个相对的心室锚定件126的人工瓣膜100。在其他实施方式中,内鞘2014可包括不同数量的槽2028,例如四个槽,其对应于所选择的人工瓣膜上心室锚定件的数量和位置。在一些实施方式中,例如图50中示出的,每个槽2028的近端部分2020包括成圆形的开口,该开口具有比该槽其余部分更大的角宽度。
易破裂(break-away)或易碎的保留带(retaining band)2022可位于内鞘2014的远端部分2016周围,如图50所示。带2022可帮助保持内鞘2014的远端部分2016展开(splayapart)来自包含在内鞘2014内的压缩人工瓣膜100的力。带2022包括近端边缘2024,所述近端边缘2024可包括位于内鞘2014中的槽2028上的至少一个凹口2026。带2022可包括易碎材料,并且可被配置为当足够的轴向力被施加到凹口2026上时,在凹口位置处撕开或破裂。在使用中,带2022被配置为当其从内鞘2014上展开时,在瓣膜100的心室锚定件126的力下,在凹口2026处破裂,如以下进一步所描述的。
外鞘2036同轴地位于内鞘2014的一部分周围,并相对于内鞘轴向可滑动。外鞘2036可被放置以覆盖内鞘2014的远端部分2016的至少一部分。在这样的覆盖位置上,例如图55中示出的,心室锚定件可被包含在内鞘和外鞘之间。外鞘2036位于该覆盖的位置上,同时负载的递送系统2000被插入通过身体并进入左心室6。外鞘2036可相对于鞘2014向近端缩回,以显露槽2028,并允许心室锚定件126在展开期间通过内鞘2014中的槽向外弹起。可选地,内鞘2014可相对于外鞘2036向远端推进,以显露槽2028。
参考图51,递送系统2000的手柄部分2002可包括便于使内鞘2014和外鞘2036沿它们各自的轴向移动范围来回滑动的部件,以负载、递送和展开人工瓣膜100。外鞘把手2052可被附接至外鞘2036的近端。医生可抓住外鞘把手2052并相对于递送系统2000的其余部分向近端或远端推动或拉动外鞘2036。外鞘也可被安装在导螺杆(未示出)上。递送系统2000的手柄部分2002可进一步包括外壳2054,所述外壳2054为医生提供把手或手柄,以保持递送系统2000稳定,同时她使用另一只手启动鞘。滑动导螺杆2056可被固定(例如,粘合、机械锁定等)至内鞘2014的近端部分2058并位于外壳2054内。导螺杆2056可相对于外壳2054可旋转固定,并可被限于外壳内的轴向滑动范围。可旋转套筒2060可同轴地位于外壳2054和内导螺杆2056之间,并可包括无外壳2054延伸的近端旋钮部分2062,以为医生提供把手来旋转可旋转套筒2060。可旋转套筒2060可相对于外壳2054自由旋转,但相对于外壳被轴向固定。导螺杆2056可包括与可旋转套筒2060上的向内突出脊2066相互作用的外螺旋沟槽2064,以便当旋钮2062相对于导螺杆2056和外壳2054旋转时,脊2066使导螺杆2056轴向滑动,由此使内鞘2014也轴向滑动。因此,医生可通过相对于外壳2054一个方向旋转旋钮2062向近端移动内鞘2014,并通过相对于外壳反向旋转旋钮向远端移动内鞘2014。外壳2054可相对于推动器杆2010进行固定,以便当旋钮2062相对于外壳进行旋转时,导螺杆2056和内鞘2014一起相对于推动器杆2010和外壳2054轴向滑动。
如图51所示,内杆2006一直穿过递送系统2000的手柄部分2002,并且推动器杆2010可终止于或接近手柄部分2002的近端帽2068处。在内杆2006的外表面和推动器杆2010的内表面(见图52和53)之间的环形空间2012可被流体连接至手柄部分2002的末端帽2068中的至少一个冲洗口2070。冲洗口2070可提供入口,以便将流体注入环形空间2012和/或允许流体流出环形空间。
如图49所示,鼻锥体(前锥体,nose cone)2030可被附接至内杆2006的远端。鼻锥体2030可从近端基底2034逐渐变细至远端尖端2032。基底2034可具有大约等于外鞘2036直径的直径。鼻锥体2030可通过相对于递送系统2000的其余部分向近端滑动内杆2006向近端缩回,以配合外鞘2036和/或内鞘2014的远端,以便进一步容纳压缩的人工瓣膜100,如图55所示。鼻锥体2030也可向远端移动,远离鞘,以便为人工瓣膜100提供负载和/或展开的空间。在插入递送系统2000通过身体期间,逐渐变细的鼻锥体2030可起楔的作用,以引导递送系统2000的插入部分2004进入身体,并且当递送系统前进通过身体时,提供无损伤性的末梢,以最小化对周围组织的损伤。
为了将人工瓣膜100载入递送系统2000,鼻锥体2030必须向远端移动远离鞘,并且内鞘2014必须向远端前进至递送位置,如图54所示(不含保留带2022)。外鞘2036可被缩回以暴露内鞘2014中的槽2028。人工瓣膜100随后被放置在鼻锥体2030和内鞘2014之间并围绕内杆2006的位置。人工瓣膜100随后被压缩至压缩状态并滑入内鞘2014,以便人工瓣膜的近端或下端邻近或接触推动器末梢,如图56所示。负载的锥体或等同机构可用于将瓣膜100插入内鞘2014。在包括推动器构件204的人工瓣膜100的实施方式中,例如在图25中,推动器构件204的底端206可接触推动器末梢2018,如图56所示。可允许心室锚定件126通过各自槽2028的圆形近端部分2020伸出,如图54所示。每个槽的近端部分2020可具有足够的角宽度,以允许心室锚定件126的两个末端部分并排位于槽内,其可使心室锚定件的中间部分呈现期望形状,用于植入在小叶10,12后面。易破裂保留带2022可位于内鞘2014的远端部分周围,以便带2022中的每个凹口2026都位于各自的槽上,如图50所示。外鞘2036随后向远端前进以覆盖槽2028,如图55所示,由此压缩心室锚定件126并将心室锚定件限制在外鞘2036内。可选地,人工瓣膜可被插入内鞘2014,同时外鞘2036覆盖槽2028,以便心室锚定件126位于槽中,但不能伸出槽。心室锚定件126也可被限定在内鞘2014的外表面和外鞘2036的内表面之间。在任何情况下,一旦外鞘2036被缩回,心室锚定件126就自由地径向向外弹起。在人工瓣膜100处于内鞘2014内之后,内杆2006可被缩回以拉动鼻锥体2030紧靠内鞘2014和/或外鞘2036的远端,如图55所示。随着人工瓣膜100在内杆2006内、鼻锥体2030缩回并且外鞘2036限制心室锚定件126,递送系统2000处于负载构造,并准备插入身体。
在图55中示出的负载构造中,负载的递送系统2000可通过心脏尖端38插入左心室6,首先被插入的是鼻锥体2030,并被放置在接近二尖瓣区域的位置,以展开。导引器鞘(未示出)可首先通过心脏中的切口插入,以提供用于将递送系统2000引入心脏的口。另外,递送系统2000可在递送系统2000之前进入心脏的传统导线(未示出)上前进。把手2052可随后相对于递送系统的其余部分向近端移动,以便相对于内鞘2014缩回外鞘2036,并使心室锚定件126向外弹起,远离内鞘2014,如图56和57所示,以便心室锚定件延伸通过槽2028的圆形近端部分2020。递送系统期望被可旋转地定位,以便每个心室锚定件126都位于附接至天然二尖瓣小叶10,12之一的腱索16组之间。接下来,递送系统2000可通过心房(atrially)前进,以便鼻锥体2030进入天然二尖瓣孔并且伸出的心室锚定件126在各自的小叶10,12和心室壁20之间移动,如图58所示。随后,在保持递送系统2000的外壳2054稳定的同时,医生可相对于外壳旋转可旋转套筒2060的旋钮2062,以便向近端缩回内鞘2014。当内鞘2014缩回时,推动器末梢2018保持静止,由此当其从内鞘2014被显露和展开时,压缩的人工瓣膜100留在相同的轴向位置上。可选地,内鞘2014可保持静止,同时推动器末梢2060向远端移动,以将瓣膜100推出内鞘2014。当内鞘2014相对于推动器末梢2018缩回时,推动器末梢可在远端方向上,对人工瓣膜100的近端表面或下表面施加轴向力。在具有推动器构件204的人工瓣膜的实施方式中,推动器构件204可直接引导该轴向力至主体122并防止推动器末梢2018和心室锚定件126之间的直接接触,以减少损害心室锚定件的危险。
当内鞘2014相对于人工瓣膜100缩回时,包括向下折叠的心房密封件124的人工瓣膜的远端部分或上部分首先显露。参考图59和60,当内鞘2014已经被缩回超过人工瓣膜100的心房密封件124的外缘时,心房密封件可径向向外弹起远离主体122,绕主体的远端枢轴转动。
当内鞘2014相对于人工瓣膜100缩回时,穿过槽2028的圆形近端部分2020的心室锚定件126的末端部分被迫使通过槽2028的较窄远端部分,朝向保留带2022,如图59和60所示。心室锚定件的末端部分开始在槽的较宽近端部分2020中是并排的。当被迫使进入槽2028的较窄部分时,每个心室锚定件126的两个末端部分可径向重叠,或将一个定位在另一个上面,与并排相反。在其他实施方式中,槽2028可较宽,以便心室锚定件126的两个末端部分可并排地在槽2028附近移动。当心室锚定件126移动朝向槽2028的远端时,心室锚定件可接触保留带2022中的凹口2026,如图60所示,并且可切割带2022或以其他方式使带在凹口位置处撕开或分开,如图61所示。当内鞘2014缩回超过人工瓣膜100的近端或下端时,压缩的人工瓣膜体可弹性自膨胀至膨胀状态,如图61所示。当人工瓣膜膨胀时,心室锚定件126和主体122的外表面之间的间隔减小,抓住心室锚定件126和主体122之间的小叶10,12,如图23和62所示。人工瓣膜100的主体122的膨胀可迫使打开天然二尖瓣小叶10,12,保持天然二尖瓣2处于开放位置。人工瓣膜100可随后取代天然二尖瓣2的功能性。在人工瓣膜100膨胀后,递送系统的内杆2006可被缩回,穿过人工瓣膜拉回鼻锥体2030,并且整个递送系统2000可被缩回离开身体。
在一些实施方式中,可利用导线(未示出)引导递送系统2000进入和/或离开身体。导线可被插入心脏并穿过天然二尖瓣孔,并且随后导线的近端可穿过(thread)内杆2006的腔2008。随后可利用导线引导递送系统的路径,将递送系统2000插入通过身体。
心房进路
可选地,人工瓣膜100可从左心房4递送至天然二尖瓣区域。参考图63-67,一种用于从二尖瓣区域的心房侧递送人工瓣膜的进路使用递送导管2100。人工瓣膜100首先从膨胀状态蜷曲至径向压缩状态并载入递送导管2100的远端部分处的初级鞘2102且也任选的次级鞘,如图63所示。递送导管2100用于引导人工瓣膜100通过身体并进入左心房4。人工瓣膜100在鞘2102内定向,以便人工瓣膜100的流出端112(支撑心室锚定件126的末端)最接近于鞘的远端并因此首先进入左心房4,并且人工瓣膜的流入端110(心房密封件124)最后进入。鞘2102可随后以多种方式插入左心房4,一个例子为图66中示出的经心房进路,另一个例子为图67中示出的经中隔进路。当递送导管2100用于经由患者的脉管系统进入心脏时,例如图67中示出的,导管2100可包括柔性、可操纵的导管。
一旦位于左心房4中,初级鞘2102的远端2104可被移动穿过二尖瓣环8,以便在从鞘展开心室锚定件之前,心室锚定件126位于超出二尖瓣小叶10,12的位置。
可随后利用位于鞘2102内并且可相对于鞘轴向滑动的刚性推动器杆2106(见图64),从初级鞘2102的远端2104部分地推出人工瓣膜100。当相对于推动器杆2106和人工瓣膜100向近端缩回鞘2102时,推动器杆2106促使人工瓣膜向远端离开鞘2102,如图64所示。可选地,可向远端移动推动器杆2106,而保持鞘2102在适当位置,由此向远端推动人工瓣膜100离开鞘。
当初级鞘2102被插入穿过二尖瓣环8并经过小叶10,12的下端时,人工瓣膜100可被部分推出,以释放心室锚定件126,如图64所示。当它们从鞘2102被释放时,被释放的心室锚定件126可向外弹起。任选地,鞘2102可随后滑回到主体122暴露的部分上,以便仅心室锚定件显露,如图65所示。为了完成该步骤,框架的心房端可包括零件(未示出),例如机械锁定零件,用于将人工瓣膜100可拆卸地附接至推动器杆2106,以便推动器杆可拉动人工瓣膜返回鞘2102。随后向近端通过心房缩回鞘2102和人工瓣膜100,以便向外伸出的心室锚定件126在各自的小叶10,12和心室壁20之间移动,如图66-68所示。在其他实施方式中,例如图44和45中示出的那些,当心室锚定件从鞘2102释放时,心室锚定件可向上弹性偏转或在各自的小叶10,12周围弯曲。
任选地,递送导管2100也可包括外鞘2102内的次级鞘(未示出)并可包含推动器杆2106、心房密封件124和框架的主体122,但不包含锚定件126。在图63中示出的位置中,次级鞘的远端可位于锚定件126和主体122之间。当外初级鞘2102被缩回时,如图64中,次级鞘可保留在压缩框架的主体122的位置处,而锚定件126被释放,以向外延伸。因为次级鞘保持覆盖并压缩主体122,所以不需要用初级鞘2102重新覆盖主体,如图65中。相反,通过一致地向近端移动次级鞘和推动器杆,向近端移动人工瓣膜100。随后,为了从次级鞘推出人工瓣膜100,相对于推动器杆2106向近端缩回次级鞘。
在心室锚定件126位于小叶10,12后的位置并且人工瓣膜100的其余部分从初级鞘2102推出后,人工瓣膜100可膨胀至其功能尺寸,如图62和69所示,由此抓住心室锚定件126和主体122之间的小叶10,12。一旦人工瓣膜100被植入,递送导管2100可被缩回离开身体。
在可选的人工瓣膜实施方式中,框架的主体和心房密封件可为可塑性膨胀的,并且当人工瓣膜位于期望位置时,可由球囊导管的球囊(未示出)膨胀。在这样的实施方式中的心室锚定件可显示期望的弹性量,以便在展开期间辅助定位心室锚定件和主体之间的小叶10,12。一旦人工瓣膜充分膨胀,球囊可穿过膨胀的人工瓣膜收回并离开身体。
二尖瓣回流减少
当在心脏收缩的收缩阶段期间,天然二尖瓣不能恰当关闭,并且血液从左心室流入左心房时,二尖瓣回流(MR)发生。MR为最常见形式的心脏瓣膜疾病。MR具有不同的起因,例如小叶脱垂、功能失调的乳头肌和/或由左心室扩张引起的二尖瓣环的拉伸。在小叶中心部分的MR可被称为中心射流(central jet)MR,较接近小叶的一个连合的MR可被称为偏心射流(eccentric jet)MR。
不是完全替换天然二尖瓣,治疗MR的另一种方式是通过在小叶之间放置减小回流孔区域的假体间隔物,允许二尖瓣以很少的回流或无回流起作用,同时最小化对天然瓣膜和左心室功能以及对周围组织的影响。关于MR治疗的另外信息可在美国专利7,704,277号和美国公布号2006/0241745A1中找到,两者都在此通过引用并入。
图71显示了示例性假体间隔物实施方式3000,利用其,间隔物或其他物体可利用在此描述的固定原理,在小叶之间被悬浮或“浮动”。假体间隔物3000可包括框架3002和间隔体3004。间隔体3004可包括聚氨酯、泡沫和/或其他合适的材料(一种或多种),并可任选地被涂布有特氟纶(Teflon)和/或其他合适的材料(一种或多种)。间隔体3004可包括贴合前小叶10和后小叶12之间的月牙形接合点的月牙形状(见图4A和4B),或间隔体可包括其他合适的形状,例如椭圆、圆形、沙漏形等。根据间隔体3004的形状和间隔体相对于天然结构的定位,假体间隔物3000的实施方式可帮助治疗中心射流MR、偏心射流MR或两者。
此外,间隔体3004可包括最小的横向横截面积和逐渐变细的边缘。该形状可减少来自通过二尖瓣从左心房至左心室的血液流动的舒张力。当在间隔体周围闭合天然瓣膜时,该形状也可减少间隔体3004上的收缩力,并且自然地将大部分收缩力放置在天然小叶和腱索上。因此,间隔体3004的形状可减少传递至锚定件接合位置处的天然瓣膜组织的力,其可减少接合位置处穿孔和腐蚀的可能性和支撑小叶的天然腱索破裂的可能性。假体间隔物3000的总体最小尺寸可进一步提供减小所要求的递送系统的横截面大小的机会,允许经由身体和心脏中较窄的脉管系统和/或更小侵入性的切口递送。
框架3002可由结实、柔性的材料例如镍钛诺制成。如图71所示,框架3002可包括框架体3006、前心室锚定件3008、后心室锚定件3010、前心房锚定件3012和后心房锚定件3014。框架体3006可包括延伸通过间隔体3004的大体上纵向的柱。以下详细描述了框架体3006的多种实施方式。
框架3002可进一步包括一个或多个从框架体3006横向延伸通过间隔体3004的间隔物膨胀器3024。膨胀器3024可弹性地膨胀离开框架体,并在展开期间协助间隔体3004的膨胀。在一些实施方式中,间隔物膨胀器3024可为圆柱形框架体3006的矩形切开口部分,如图71所示,其被径向弯曲远离框架体。
前心室锚定件3008被配置为从框架体3006的心室端,围绕前小叶10的A2边缘延伸,并在小叶后向上延伸至二尖瓣环8的心室表面和/或前小叶的环连接部分上的位置,而前心房锚定件3012被配置为从框架体3006的心房端径向延伸至与前心室锚定件3008相对的二尖瓣环8心房表面上的位置。类似地,后心室锚定件3010被配置为从框架体3006的心室端,围绕后小叶12的P2边缘延伸,并在小叶后向上延伸至二尖瓣环8的心室表面和/或后小叶的环连接部分上的位置,而后心房锚定件3014被配置为从框架体3006的心房端径向延伸至与后心室锚定件3010相对的二尖瓣环8心房表面上的位置。
心室锚定件3008,3010和心房锚定件3012,3014可分别包括宽阔的接合部分3016、3018、3020和3022,其可被配置以压缩二尖瓣环8和/或小叶10,12的环连接部分,以保持假体间隔物3000不在心房和心室方向上移动。宽阔的接合部分可提供在锚定件和天然组织之间的更大的接触面积,以分配负载并减少损害天然组织的可能性,例如在接合位置处的穿孔或腐蚀。在图解的构造中的心室锚定件3008,3010环绕天然小叶10,12,并且不压缩天然小叶紧靠间隔体3004的外表面,允许天然小叶在间隔体3004周围自然地打开和闭合。
如图74所示,二尖瓣环8大体上为肾脏形的,这样前-后尺寸指的是环的短尺度。因为假体间隔物3000可在天然二尖瓣2的前和后区域固定,所以根据环8的短尺度可设定假体间隔物的大小。二尖瓣环8的短尺度的回声和CT测量是设定假体间隔物3000大小的示例性方法。
图75-79图解了用于将假体间隔物3000递送至心脏的天然二尖瓣区域的示例性方法。假体间隔物3000可利用包括外鞘3030和内转矩杆3032的递送系统递送入心脏。假体间隔物3000被压缩并负载入外鞘3030的远端,心房锚定件3012,3014被首先负载。如图75所示,心房锚定件向近端弹性地延伸,且心室锚定件3008,3010向远端弹性地延伸,以便假体间隔物3000呈现足够窄的横截面积,以安装到外鞘3030的腔内。在外鞘3030内,放置假体间隔物3000,以便框架体3006的心房端邻接转矩杆3032的远端,心房锚定件3012,3014位于转矩杆和外轴的内壁之间,压缩的间隔物3004邻接外鞘的内壁,并且心室锚定件3008,3010的远端邻近外鞘的远端开口。转矩杆3032可以被可拆卸地例如在框架体3006的近端处与假体间隔物3000的心房端相连接。
一旦被负载,递送系统可例如经由心房隔膜30被引入左心房4,并且外鞘3030的远端可穿过天然二尖瓣2并进入左心室6,如图75所示。
接下来,外鞘3030可相对于转矩杆3032被缩回,以便从外鞘的远端开口推出心室锚定件3008,3010。在该点上,转矩杆3032可被旋转,以便根据需要旋转在外鞘3030内的假体间隔物3000(或任选地,转矩杆和外鞘可都被旋转),以便用对齐心室锚定件和天然瓣膜2的A2/P2方位(aspect)。在转矩杆3032和假体间隔物3000之间的可拆卸附接可足以将转矩从转矩杆传递至假体,以便根据需要旋转假体。心室锚定件3008,3010可被预成形,以便当它们逐步从外鞘3030推出时,它们开始相互卷曲分开并围绕小叶的A2/P2区域。该卷曲移动可为期望的,以避免与心室壁的缠结。当外鞘3030缩回至框架体3006的心室端时,如图76所示,心室锚定件3008,3010完全从外鞘推出并位于小叶后。整个递送系统和假体可随后向近端移动,直到心室锚定件的接合部分3016,3018邻接二尖瓣环8的心室侧和/或小叶10,12的环连接部分。
接下来,外鞘3030可相对于转矩杆3032进一步缩回,以便外鞘的远端与框架体3006的心房端齐平,如图77所示,其允许压缩的间隔物膨胀器3024和压缩的间隔体或其他体3004径向向外弹性自膨胀至充分膨胀的、起作用的状态。注意,间隔体3004大部分在垂直于环的短尺度的方向上膨胀,或朝向连合36膨胀(见图74)。在一些实施方式中,间隔体3004可从压缩状态打开或展开至膨胀状态,并且在一些实施方式中,例如可使用盐水或随时间硬化的环氧树脂膨胀间隔体。
一旦间隔体在瓣膜内膨胀,如图77所示,可进行间隔物的血液动力学评估,以评估假体间隔物3000在减少MR方面的有效性。根据评估的结果,可继续展开或假体间隔物3000可被恢复、缩回和/或重新放置,以便展开。
从图77中示出的位置,外鞘3030可被推回间隔体3004上(通过相对于转矩杆3032推进外鞘3030),使间隔体再次压缩,如图76所示。在一些实施方式中,心室锚定件不是可恢复的,尽管在一些实施方式中,心室锚定件可足够柔韧,以便被重新弄直和恢复,在该情况下,则整个递送过程可被倒转并重新开始。从图76中示出的位置,递送系统可被重新放置,并且间隔体3004可被重新展开并重新评估。
一旦心室锚定件3008,3010和间隔体3004被可接受地展开,外鞘3030可相对于假体间隔物3000和转矩杆3032被进一步缩回,以便从外鞘推出心房锚定件3012,3014,如图78所示。一旦完全被推出,心房锚定件弹性卷曲至图78中示出的它们的最终展开位置,它们的接合部分3020,3022分别被挤靠与心室锚定件的接合部分3016,3018相对的环8的心房侧和/或小叶10,12的环连接部分,由此压缩在A2和P2区域处的环和/或小叶的环连接部分,以保持假体间隔物3000在天然二尖瓣区域2内。
一旦心房锚定件3012,3014被展开,转矩杆3032可从框架体3006的心房端被拆卸。递送系统可随后缩回离开身体,留下植入的假体间隔物3000,如图79所示。
在一些实施方式中,间隔体3004可包括瓣膜结构3040,如图80和82中示出的实施方式。瓣膜结构3040可与天然二尖瓣2结合起作用,以调节左心房4和左心室6之间的血液流动。例如,瓣膜结构3040可位于天然小叶之间,以便天然小叶接近瓣膜结构的外部周围,以使一些血液流动通过瓣膜结构,而其他血液在瓣膜结构的外部和天然小叶之间流动。瓣膜结构3040可包括三小叶构造,例如参考瓣膜结构104本文描述的和图5-7中示出的。
在一些实施方式中,框架体3006可包括圆柱体,其可任选地包括例如在图71-74中的实体壁管(solid-walled tube)、例如在图82中的网状金属线格子3046或其他圆柱形构造。参考图71-75,框架体3006和任选地一个或多个锚定件可由实体壁管例如镍钛诺形成,其中心房锚定件例如通过激光切割,由管的一部分形成,心室锚定件由管的第二部分形成,并且框架体由在第一和第二部分之间的管部分形成。锚定件可随后例如通过热处理形成期望的植入构造。在这样的实施方式中,锚定件和框架体可为单片体或整片结构。
在其他实施方式中,框架体3006可包括弹簧样的螺旋盘绕的金属线柱3050,如图83所示。这样的盘绕柱3050可由具有圆形或矩形横截面的金属线制成,并可包括弹性的柔性材料,例如镍钛诺,其提供了横向柔韧性,以便贴合天然瓣膜结构,同时维持纵向柱刚度,用于递送。在这些实施方式的一些中,框架体3006可包括四金属线的四螺旋(quadrahelical)线圈,其具有延伸形成心房锚定件3012,3014的四个心房端和延伸形成四个心室锚定件3008,3010的四个心室端。
在其他实施方式中,框架体3006可包括多个纵向构件(未示出)。在一个这样的例子中,框架体3006可包括四个纵向构件:延伸形成前锚定件3012,3014的两个纵向构件和延伸形成后锚定件3008,3010的两个纵向构件。
在其他实施方式中,框架体3006可包括沿身体纵向方向的Z字形切开口3050,如图81所示,其也可提供横向柔韧性,同时维持柱强度。
在一些实施方式中,假体间隔物3000可具有附加的锚定件。在一些实施方式(未示出)中,假体间隔物3000可具有三对锚定件:集中在后小叶12周围的一对锚定件,例如上述的后锚定件3010和3014,和在天然小叶10,12之间的每个连合36处的一对锚定件。这些连合锚定件对可类似地包括心室锚定件和心房锚定件,并且可类似地压缩天然环8。在其他实施方式中,也可包括前锚定件3008和3012作为第四对锚定件。其他实施方式可包括这四对锚定件和/或附加锚定件的其他结合。
除了填充回流孔区域并阻止血液朝向左心房流动之外,假体间隔物3000也可对腱索增加张力,以防止左心室的进一步扩大并且防止二尖瓣环的进一步扩张。
在二尖瓣连合下方的固定
包括心室锚定件的假体装置的一些实施方式,同时包括人工瓣膜和假体间隔物,可被配置以便心室锚定件代替或除了固定在天然二尖瓣小叶10,12的A2/P2区域后之外,还固定在天然二尖瓣2的连合36下方。图84-87显示了包括心室锚定件的示例性假体装置实施方式和相关的递送方法,该心室锚定件固定在天然二尖瓣2的两个连合36下方。这些连合-固定原理主要用于人工瓣膜,但可用于包括假体间隔物在内的其他假体装置。
如图3、4和88所示,连合36为天然二尖瓣2的前小叶10和后小叶12连接的区域。邻近每个连合36的天然二尖瓣环8的部分39,如图88所示,与邻近小叶A2/P2中间部分的二尖瓣环8的部分相比,可相对更厚和/或更结实,这提供了坚硬、稳固的位置,以固定假体装置。这些环区域39可包括坚韧的纤维组织,与天然小叶组织相比,该组织能承担更大的负载,并且可形成天然的凹表面或腔。
图84和85显示了示例性假体装置4000,其在天然二尖瓣区域2处,通过在腔39之一处放置心室锚定件4002而被植入。假体装置4000可为具有小叶结构的人工瓣膜,或用于减少MR的具有间隔体3004的间隔物装置。腱索16附接至邻近连合36的小叶10,12,其可能在将心室锚定件放置在腱索后的腔39中存在障碍。然而,有可能在腱索16周围递送锚定件例如锚定件4002,以到达腔39。可期望在这些天然腔39中,将心室锚定件的接合部分例如接合部分4004放置在腱索16后,以保持假体装置在天然二尖瓣区域2处。然而,为了避免与天然腱索16缠结和/或损害天然腱索16,可期望首先引导锚定件的接合部分垂直地位于A2/P2区域的小叶10,12后,在来自后内乳头肌22的腱索16和来自前侧乳头肌24的腱索16之间,如图84所示,随后在腱索16后周围朝向连合腔39水平移动或旋转锚定件的接合部分,如图85所示。
在一些这样的方法中,心室锚定件首先在小叶的A2/P2区域后展开,并且随后整个假体装置被旋转或扭曲,以便朝向腔39水平移动锚定件的接合部分,如图84和85所示。例如,在前小叶10后展开的第一锚定件可朝向腔39之一移动,而在后小叶12后展开的第二锚定件可朝向另一个腔39移动。该方法也可被称为“螺旋法”,因为整个假体被旋转,以将锚定件与天然组织接合。
如图84和85所示,包括被弯曲、弯转、钩形或大体上“L”形的锚定件4002的假体装置4000可与螺旋法一起使用。“L”形锚定件4002可包括从装置4000的体垂直向上延伸的腿部分4006、膝盖部分4008和从膝盖部分水平延伸并终止于接合部分4004的脚部分4010。在这些实施方式的一些中,“L”形锚定件4002可包括在两个位置上附接至装置4000体的环形金属线,以便金属线形成一对腿部分4006、一对膝盖部分4008和一对脚部分4010。在其他实施方式中,锚定件4002可具有其他类似的形状,例如更成弧线的形状,而不是图84中示出的直角形状。在递送入心脏期间,脚部分4010可被卷曲或包裹在装置4000的体的外表面周围。
如图84所示,为了在小叶10后垂直移动脚部分4010,而不与腱索缠结,腿部分4006可位于稍微偏离A2区域中心的位置,更接近与期望递送的腔39相对的腱索。如图84所示,腿部分4006位于右边,以便脚部分4010可在腱索16之间穿过。
在脚部分4010跳过(clear)腱索16并位于小叶后方之后,装置4000可被旋转,以水平移动接合部分4004进入腔39,如图85所示。注意到在图85中,腿部分4006可以最终位于腱索16之间的A2/P2区域,以避免干扰腱索。
尽管图84和85显示了单个锚定件4002,但前和后锚定件都可在天然瓣膜2的相对侧上,以对称的方式递送,在每个腔39上固定一个。两个锚定件4002的脚4010可指向相反方向,以便图85中示出的扭曲运动可同时将它们移动至两个腔39。在递送两个锚定件实施方式期间,两个脚部分4010可包裹装置4000的体的外表面,以便两个脚部分4010相互重叠。
在类似的实施方式中,锚定件4002可包括两个脚部分4010以相反方向延伸的桨形状(例如见图37)。尽管在腱索之间移动更加困难,但这些桨形锚定件可使装置4000以任一方向旋转,以在腔39上接合脚部分4010之一。在一些实施方式中,桨形锚定件可足够宽,以便一个脚部分4010可位于一个腔39,而另一个脚部分位于另一个腔。
因为锚定件4002每个都在两个位置处附接至装置4000的体,所以当主体被压缩时,锚定件可从装置的主体展开,形成接收小叶的间隔,如以上参考图11-22详细描述的。在一些实施方式中,当主体被压缩时,锚定件可以与主体分开,并且任一锚定件保持与主体分开,以便小叶在锚定件和装置的主体之间不被夹住或被压缩,或锚定件在膨胀期间靠近主体以接合小叶。在一些实施方式中,当随后主体膨胀时,主体可朝向锚定件移动,以减少间隔,同时维持相对锚定件的脚部分4010之间的距离。
图86和87显示了另一个示例性假体装置5000,其通过将心室锚定件5002放置在腔39以及这样进行的相应方法,植入在天然二尖瓣区域2处。在该实施方式中,装置5000可包括每侧上的一对“L”形锚定件5002(图86和87中仅一对可见),每对包括用于放置在腔39之一中的一个锚定件,和用于放置在另一个腔中的另一个锚定件。每个锚定件都可包括从装置5000的体垂直延伸至膝盖部分5008的腿部分5006,和从膝盖部分5008水平延伸至接合部分5004的脚部分5010。在其他实施方式中,锚定件5002可具有其他类似的形状,例如更成弧线的形状,而不是图86中示出的角度形状。
每对锚定件5002都可包括弹性的柔性材料,例如镍钛诺,以便它们可被预弯曲并限定在竖起的(cocked)位置上,用于在小叶后的递送,如图86所示,并且随后被释放以弹性弹离,以相对方向朝向两个腔39移动接合部分5004,如图87所示。任何合适的限制和释放机构都可被使用,例如可释放的机械锁机构。一旦被释放,一个前锚定件和一个后锚定件可相对方向的位于一个腔39处,并且第二前锚定件和第二后锚定件可相对方向的位于另一个腔。一些实施方式可在装置5000的每侧上仅包括一个锚定件,当被释放时,该锚定件以相对方向朝向相对腔39移动。
因为每对锚定件5002开始都被限制在一起,如图86所示,因此每对锚定件可像具有与装置5000主体的两个附接点的单个锚定件起作用。因此,当主体被压缩时,锚定件对可分开或膨胀离开主体,并且任一锚定件保持与主体间隔开,以便小叶在锚定件和装置主体之间不被夹住或被压缩,或锚定件在膨胀期间靠近主体以接合小叶。在一些实施方式中,当随后主体膨胀时,主体可朝向锚定件对移动,以减少间隔,同时维持相对锚定件对的脚部分5010之间的距离。
在图84-87中示出的实施方式中,假体装置4000或5000可具有类似于图5中示出的实施方式的主框架体,心室锚定件4002,5002可从该主框架体延伸,并且假体装置4000或5000可进一步包括一个或多个心房锚定件,例如与图5中示出的心房密封件124类似的心房密封件或例如与图71中示出的心房锚定件3012和3014类似的多个心房锚定件。心房锚定件可从假体装置的心房端径向向外延伸,并接触与腔39相对的天然组织,并由此压缩心房锚定件和心室锚定件4002,5002的接合部分4004,5004之间的组织,以保持假体装置在天然二尖瓣区域处。心房锚定件和心室锚定件可包括宽阔接触区域,以便在较宽区域上分配负荷并减少损害天然组织的可能性。
鉴于可以应用本文公开原理的许多可能的实施方式,应当认识到图解说明的实施方式只是优选的实施例,并且不应该看作限制本公开的范围。相反,该范围由所附权利要求所限定。因此我们要求保护所有进入这些权利要求的范围和精神内的内容。
Claims (12)
1.一种假体装置,用于植入到心脏的天然二尖瓣区域,所述天然二尖瓣具有天然环以及前天然瓣膜小叶和后天然瓣膜小叶,所述假体装置包括:
可径向压缩和可自膨胀的间隔体,所述间隔体被配置用于放置在所述前天然瓣膜小叶和后天然瓣膜小叶之间,其中所述间隔体不允许血液流过所述间隔体;
第一心室锚定件,其从所述间隔体延伸并且被配置用于放置在所述前天然瓣膜小叶之后;
第二心室锚定件,其从所述间隔体延伸并且被配置用于放置在所述后天然瓣膜小叶之后。
2.根据权利要求1所述的假体装置,其中所述装置被配置成治疗二尖瓣回流。
3.根据权利要求1所述的假体装置,其中所述间隔体具有非圆形横向横截面,该横向横截面对应于所述前天然瓣膜小叶和后天然瓣膜小叶之间的接合点的形状。
4.根据权利要求1所述的假体装置,其中所述前天然二尖瓣小叶和后天然二尖瓣小叶当植入时在心脏收缩期间围绕所述间隔体密封,并且在心脏舒张期间与所述间隔体至少部分分开。
5.根据权利要求1所述的假体装置,其中所述装置包括框架,所述框架包括连接到支撑所述间隔体的框架体的所述第一和第二心室锚定件。
6.根据权利要求1所述的假体装置,其中所述心室锚定件的至少一个包括环形金属线,所述金属线从邻近所述间隔体处延伸到对应的天然瓣膜小叶之后的位置并且回到邻近所述间隔体处。
7.根据权利要求1所述的假体装置,其中所述心室锚定件的至少一个以心室方向从邻近所述间隔体处延伸并且弯曲以朝向所述天然瓣膜小叶之后的位置以心房方向延伸。
8.一种假体间隔物,用于植入到心脏的天然二尖瓣区域,所述天然二尖瓣具有天然环、前天然瓣膜小叶和后天然瓣膜小叶以及天然二尖瓣孔,所述假体间隔物包括:
可径向折叠和可膨胀的间隔体,所述间隔体被配置成位于天然二尖瓣孔内,从而使得所述间隔体与所述前天然瓣膜小叶和后天然瓣膜小叶协作,以在心脏收缩期间阻止血液流过所述天然二尖瓣孔,同时在心脏舒张期间允许血液在所述间隔体的外表面与所述前天然瓣膜小叶和后天然瓣膜小叶的至少一个之间流动;以及
第一心室锚定件,其连接到所述间隔体并且被配置成位于所述前天然瓣膜小叶之后;和第二心室锚定件,其连接到所述间隔体并且被配置成位于所述后天然瓣膜小叶之后。
9.根据权利要求8所述的假体间隔物,其中所述间隔体具有非圆形横向横截面,该横向横截面对应于所述前天然瓣膜小叶和后天然瓣膜小叶之间的接合点的形状。
10.根据权利要求8所述的假体间隔物,其中所述间隔体具有逐渐变细的边缘,以在心脏舒张期间减少对所述间隔体周围的血流的阻力。
11.根据权利要求8所述的假体间隔物,其中所述心室锚定件的至少一个以心室方向延伸超过所述间隔体的心室端。
12.根据权利要求8所述的假体间隔物,其进一步包括框架,所述框架包括连接到支撑所述间隔体的框架体的所述第一和第二心室锚定件,其中所述心室锚定件的至少一个通过一个或多个套筒附接至所述框架体。
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