CN102196784A - 人工心脏瓣膜和输送设备 - Google Patents
人工心脏瓣膜和输送设备 Download PDFInfo
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- 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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Abstract
本发明的实施例提供人工心脏瓣膜和经人脉管系统向自体瓣膜部位输送人工心脏瓣膜的心脏瓣膜输送设备。输送设备特别适合将人工瓣膜前进通过主动脉(即,以倒退/逆行方法)以便替换患病的自体主动脉瓣膜。在一个实施例中,自膨胀瓣膜包含经成形从而逆轴向将瓣膜维持在主动脉环中而没有啮合周围组织的锚固或保持器件的可膨胀支架。输送自膨胀人工瓣膜的输送设备可经配置允许从瓣膜鞘管受控和准确展开瓣膜,以便最小化或防止瓣膜从瓣膜鞘管跳出。
Description
技术领域
本发明涉及人工心脏瓣膜和移植人工心脏瓣膜的输送设备的实施例。
背景技术
人工心脏瓣膜许多年来用于治疗心脏瓣膜疾病。自体心脏瓣膜(例如大动脉、肺部和二尖瓣瓣膜)在确保适度供应的血液向前流动通过心血管系统中起到了关键作用。这些心脏瓣膜可由于先天、发炎或传染情况而表现出较低效率。这种对瓣膜的损伤可导致严重心血管危害或死亡。许多年来,这样病症的确切疗法是在开心手术期间的外科修补或替换瓣膜,但这样的手术易发许多并发症。新近已经研发了经脉管技术从而以侵入性少于开心手术的方式使用柔性导管导引和移植人工心脏瓣膜。
在该技术中,人工瓣膜以卷曲状态安装在柔性导管的末端部分上,并前进通过病人的血管直到瓣膜到达移植部位。在导管尖的瓣膜然后在缺陷性自体瓣膜部位膨胀到它的功能性尺寸,例如通过使得其上安装有瓣膜的球囊膨胀。可替换地,瓣膜可具有弹性自膨胀的支架或框架,该支架或框架当从在导管远端的输送鞘管前进时将瓣膜膨胀到它的功能性尺寸。
球囊可膨胀瓣膜通常优选用于替换钙化的自体瓣膜,因为导管球囊可施加充足的扩径力从而将人工瓣膜的框架锚固到周围钙化的组织。另一方面,自膨胀瓣膜通常优选用于替换缺陷性、非狭窄的(非钙化的)自体瓣膜。关于移植自膨胀瓣膜的一个缺点是在操作员开始将瓣膜从输送鞘管的开口端前进时,瓣膜趋向于从鞘管的末端非常快“跳”出;换言之,瓣膜框架的向外偏置力趋向于导致瓣膜从输送鞘管的远端非常快地弹出,从而使得难以以准确且受控的方式从鞘管输送瓣膜,并增加了病人外伤的可能性。
关于在非狭窄自体瓣膜中移植经皮人工瓣膜的另一问题是人工瓣膜可能不能对周围组织施加充足力从而抵抗人工瓣膜的迁移。通常,人工瓣膜的支架必须均具有额外锚固或附加器件,从而辅助将瓣膜锚固到周围组织。此外,有助于锚固瓣膜的支架的这样锚固器件或部分通常延伸到脉管系统的非患病区域内并固定于此,如果需要未来干预,例如如果需要从病人移除人工瓣膜,那么这可能导致并发症。
发明内容
本公开的某些实施例提供人工心脏瓣膜和经人体脉管系统向自体瓣膜部位输送人工心脏瓣膜的心脏瓣膜输送设备。输送设备特别适合使得人工瓣膜前进通过主动脉(即,以倒退/逆行方式)以便替换患病的自体主动脉瓣膜。
在人工心脏瓣膜的一个实施例中,瓣膜包含径向可膨胀和可压缩支持框架或支架,以及支架支持的多个瓣叶(leaflet)。支架理想地包含相互互联的多个立柱构件,从而形成具有流入端和流出端的网孔结构。网孔结构可具有总体弯曲的形状,该形状从流入端向减小的直径段向内渐细,从减小的直径段向扩张的中间段直径增大,而且之后从中间段朝向网孔结构的流出端渐细。瓣膜可移植在自体主动脉瓣膜中,以使减小的直径段位于自体瓣膜的环内,流入端部分在瓣膜环稍下方延伸,并且扩张的中间段在瓣膜环稍上方延伸到Valsalva窦。张开的流入端部分和扩张的中间段直径大于自体环,并因此有助于抵抗趋向于在上游和下游方向上使瓣膜移位的力而保持瓣膜就位。由于支架的几何形状,因此瓣膜特别适合代替通常不锚固人工瓣膜的非狭窄瓣膜以及钙化的自体瓣膜。支架理想地不包括有助于锚固瓣膜就位的额外锚固器件或框架部分。因此,可移植瓣膜而不接触脉管系统的非患病区域,如果需要未来干预的话那么这样防止了或至少最少化了并发症。
瓣膜的多个瓣叶具有相应流入端部分和流出端部分。瓣叶的流入端部分可在网孔结构的流入端部分处被固定到网孔结构的内部。瓣叶的流出端部分定义可在网孔结构的流出端处被固定到网孔结构内部的成角度隔开的连合。
输送自膨胀人工瓣膜的输送设备可经配置允许从瓣膜鞘管受控且准确地展开瓣膜,以便最小化或防止瓣膜从瓣膜鞘管跳出。在一个实施例中,瓣膜连接到细长瓣膜导管的远端,并且鞘管从在瓣膜导管外层/之外/之上(over)延伸的外导管的远端延伸。为了从鞘管展开瓣膜,瓣膜导管相对于外导管和鞘管旋转,从而影响鞘管相对于瓣膜的滑动,直到瓣膜从鞘管的远端展开。随着瓣膜从鞘管前进,瓣膜导管保持瓣膜抵抗可由于瓣膜自然弹回而导致的瓣膜不受控的前进或从瓣膜鞘管跳出。在另一实施例中,外轴可连接到位于输送设备把手中的螺钉轴。螺钉轴可以可操作地连接到由用户旋转的致动器旋钮从而在纵向方向上移动螺钉轴和外轴。外轴在向近端方向上的纵向移动有效地相对于瓣膜撤回鞘管,从而以准确且受控的方式从鞘管展开瓣膜。
输送设备可包括在瓣膜和输送设备的远端之间形成可释放连接的保持机构。保持机构在瓣膜从鞘管展开后相对于输送设备保持瓣膜,从而允许用户调整膨胀的瓣膜相对于目标移植部位的位置。在一个实施例中,保持机构可包括具有形成具有接收瓣膜支架的相应支柱的开孔的多个尖头的第一叉。第二叉具有延伸通过第一叉的尖头中相应开孔的多个尖头,从而形成与支架的每个支柱之间的可释放连接。凭借该设置,可通过操纵输送设备的把手来调整膨胀瓣膜在病人体内的位置。为释放瓣膜,第二叉撤回从而从支架中的开孔抽回其尖头,而留下被移植在体内的瓣膜。在另一实施例中,保持机构可包含从输送设备的远端延伸的多个缝线。每个缝线都延伸通过支架的开孔或钩部分,并在其远端具有环圈,其中释放线延伸通过该环圈。为释放瓣膜,释放线从缝线环圈撤回,从而允许缝线从输送设备的远端释放瓣膜。
在代表性实施例中,经病人脉管系统输送人工心脏瓣膜的心脏瓣膜输送设备包含:导管,该导管包含适合延伸通过脉管系统的柔性转矩轴,该转矩轴具有耦合到人工瓣膜的远端部分;以及瓣膜鞘管,其被配置成在耦合到导管的远端部分以便通过病人脉管系统输送到心脏时接收处于径向收缩状态的瓣膜。该设备经配置以使转矩轴的旋转有效地导致在鞘管和瓣膜之间的相对纵向移动,从而使得瓣膜从鞘管前进以便展开在心脏中。
在另一代表性实施例中,提供在病人体内移植人工自膨胀心脏瓣膜的方法。该方法包含:在输送设备的鞘管内安装处于径向压缩状态的瓣膜,该瓣膜耦合到输送设备的细长导管;将输送设备插入病人脉管系统内并使得瓣膜朝向移植部位前进;以及将导管相对于鞘管旋转,这导致在鞘管和导管之间的相对纵向移动,从而使得瓣膜从鞘管前进且膨胀。
在另一代表性实施例中,经病人脉管系统输送人工带支架心脏瓣膜的心脏瓣膜输送设备包含具有远端部分的至少一个细长导管以及将瓣膜耦合到导管的远端部分的瓣膜保持机构。保持机构包含第一叉和第二叉,每个叉都具有多个成角度隔开的尖头,第一叉的每个尖头都与第二叉的对应尖头配合从而形成与瓣膜的支架的可释放连接,第二叉相对于第一叉可移动,从而释放尖头和支架形成的每个连接。
在另一代表性实施例中,提供在病人体内移植人工心脏瓣膜的方法,该瓣膜包含径向可压缩且可膨胀的支架。该方法包含将压缩状态的瓣膜经包含第一叉和第二叉的保持机构连接到输送设备的远端,其中每个叉都具有多个成角度隔开的尖头,第一叉的每个尖头都与第二叉的对应尖头配合从而形成与瓣膜支架的可释放连接。该方法进一步包含将输送设备插入病人脉管系统内,并使得瓣膜前进到心脏中的移植部位,使得瓣膜在该移植部位处或邻近该移植部位的位置膨胀,并使得第二叉相对于第一叉移动,从而释放尖头和支架形成的每个连接,由此从输送设备释放瓣膜。
在另一代表性实施例中,在具有环的移植部位处移植的人工心脏瓣膜包含径向可膨胀且可收缩的支持框架。支持框架包含相互互联的多个立柱构件从而形成包含流入端和流出端的网孔结构。网孔结构包含在第一位置具有第一直径的扩张的中间部分,该中间部分在朝向流入端的方向上渐细,从而在第二位置形成具有第二较小直径的流入端部分。瓣膜进一步包含具有相应流入端部分和流出端部分的多个瓣叶,瓣叶的流入端部分在网孔结构的流入端部分处被固定到网孔结构内部,并且瓣叶的流出端部分定义在网孔结构的流出端被固定到网孔结构内部的成角度隔开的连合。
在另一代表性实施例中,输送人工心脏瓣膜的输送设备包含第一细长轴以及第二细长轴,其中所述第一细长轴具有近端和适合连接到瓣膜的远端,该第二细长轴在第一轴之上延伸并具有近端和包含经配置当瓣膜处于径向压缩状态时在瓣膜的鞘管的远端部分之上延伸。把手耦合到第一和第二轴的近端,该把手包含可旋转致动器和可操作连接到致动器且连接到第二轴近端的螺钉,其中致动器的旋转导致螺钉和第二轴相对于第一轴的纵向移动,从而相对于瓣膜撤回鞘管。
在另一代表性实施例中,输送具有支架的人工心脏瓣膜的输送设备包含具有远端部分的至少一个细长导管,以及适合在瓣膜和导管的远端部分之间形成可释放连接的可释放瓣膜保持机构。瓣膜保持机构包含从导管的远端部分延伸的多个缝线,每个缝线都延伸通过并啮合支架的一部分并在一个末端具有环圈。瓣膜保持机构进一步包含延伸通过每个缝线的环圈的细长可滑动构件,以便将瓣膜连接到导管。可滑动构件相对于缝线可撤回,从而从可滑动构件释放环圈,由此释放在瓣膜和导管之间的连接。
在另一代表性实施例中,输送人工心脏瓣膜的输送设备包含具有适合耦合到人工瓣膜的远端部分的细长导管以及瓣膜鞘管。瓣膜鞘管经配置在耦合到鞘管的远端部分时在处于径向压缩状态的瓣膜之上延伸,并包含由在瓣膜之上延伸的第一管状折叠层和在第一折叠层之上延伸的第二管状折叠层所形成的折叠部分。第二折叠层相对于导管和瓣膜纵向可移动,从而使瓣膜出鞘。
在另一代表性实施例中,组件包含人工瓣膜和输送设备,该人工瓣膜包含具有多个成角度隔开的支柱的自膨胀支架,该输送设备用于向病人体内移植部位输送瓣膜。输送设备包含具有远端部分的细长轴,远端部分具有在其外表面中形成并且尺寸上接收支架的相应支柱的多个凹处。输送设备也包含尺寸上在瓣膜之上延伸并通过被布置在相应凹处中的支柱将瓣膜保持在压缩状态的外鞘管,该鞘管和该轴相对于彼此纵向可移动从而使得瓣膜出鞘,由此允许瓣膜膨胀。
在另一代表性实施例中,导引器鞘管包含具有内腔并适合插入病人脉管系统内的细长管状套管。该套管包含金属层,该金属层包含沿金属层长度隔开的多个条带以及被夹在相邻条带之间的圆周延伸开孔。导引器鞘管可进一步包含耦合到套管近端的密封外壳。
在另一代表性实施例中,导引器鞘管包含外壳,该外壳具有内孔洞、在外壳上纵向可移动的罩帽部分、安装到罩帽部分并具有对准内孔洞的开孔的弹性体密封件。在外壳上罩帽部分从第一位置可移动到第二位置,从而在径向方向上伸展密封件以便扩大密封件中开孔。导引器鞘管也可包括从外壳的内孔洞延伸的细长管状套管,该套管具有内腔并适合插入病人脉管系统内。
本发明的前述和其它特性和优点根据参考附图进行的下面详细描述变得更明显。
附图说明
图1是可用来替换心脏的自体主动脉瓣膜的人工瓣膜的透视图。
图2是图1的瓣膜的一部分的透视图,其图解了两个瓣叶与瓣膜支持框架的连接。
图3是图1的支持框架的侧视图。
图4是图1的支持框架的透视图。
图5A是示出在主动脉环内移植的图1的人工瓣膜的心脏剖面图。
图5B是图5A的放大图,图解了移植在主动脉环内的人工瓣膜,为清晰示出而移除了瓣膜的瓣叶结构。
图6是示出被固定到支持框架之前的图1的瓣膜的瓣叶结构的透视图。
图7是图1的瓣膜的剖面图。
图8是可用来输送和移植人工瓣膜,例如在图1中示出的人工瓣膜的输送设备的分解图。
图9是输送设备的远端部分的侧面图,示出鞘管在瓣膜之上延伸并覆盖瓣膜以便输送通过病人脉管系统。
图10是输送设备的远端部分的侧面图,示出鞘管撤回从而允许瓣膜膨胀到其功能性尺寸。
图11是输送设备的远端部分的剖面图。
图12是示出鞘管内部的输送设备的一部分的剖面图。
图13是瓣膜和在瓣膜和输送设备之间形成可释放连接的保持机构的分解透视图。
图14是示出连接到保持机构的瓣膜的透视图。
图15是保持机构的一部分的放大透视图,其图解了配合从而形成与瓣膜支持框架的可释放连接的保持机构的两个尖头。
图16是输送设备的一部分的放大剖面图。
图17是瓣膜和可用来径向压缩瓣膜到压缩状态以便装载到鞘管内的装载锥体的透视图。
图18示出插入通过椎从而压缩瓣膜的瓣膜的透视图。
图19和图20示出连接到保持机构的内叉的转矩导管的远端部分。
图21和图22示出布置在连接到保持机构外叉的转矩导管上的螺钉构件。
图23和图24示出装载到输送设备的鞘管内的被压缩瓣膜。
图25是示出鞘管被部分撤回的输送设备的侧面图。
图26和图27示出相对于外叉撤回从而从保持机构释放瓣膜的保持机构的内叉。
图28示出在瓣膜释放并展开在体内之后保持机构撤回到鞘管内。
图29A是输送设备的另一实施例的远端部分的剖面图。
图29B是输送设备的另一实施例的远端部分的剖面图。
图30是输送设备的另一实施例的远端部分的侧面图。
图31是相似于图30的侧面图,示出在部分撤回位置中的输送设备的鞘管。
图32是为图解目的示出已移除了鞘管的相似于图30的侧面图。
图33是相似于图32的侧面图,示出在弯曲位置中的输送设备的一部分。该图图解了输送设备可沿含有螺钉机构的部分展现充分柔性。
图34是根据一个实施例在图30中示出的输送设备的把手部分的透视图。
图35是图解把手部分内部的透视图。
图36是图解从图30的输送设备的鞘管展开瓣膜的侧面图。
图37是图解图30的输送设备的保持机构的操作的侧面图。
图38A-38C图解用来将膨胀的瓣膜收回到输送设备内以便从身体移除的瓣膜收回器件的操作。
图39是输送设备另一实施例的侧面图。
图40是输送设备另一实施例的透视图。
图41是图40的输送设备的把手组件的放大剖面图。
图42是在图41中示出的把手组件的分解透视图。
图43是在图41中示出的把手组件的鞘管调整旋钮的放大透视图。
图44是在图43中示出的鞘管调整旋钮的剖面图。
图45是在图43中示出的调整旋钮的啮合闩锁的放大前视图。
图46是在图40中示出的输送设备的远端部分的放大透视图。
图47是图40的输送设备的远端部分的放大透视图,示出其中鞘管撤回从而图解用来将人工瓣膜(未示出)固定到输送设备的缝线。
图48是图40的输送设备的远端部分的放大透视图,图解在人工瓣膜和输送设备之间形成可释放连接的技术。
图49是图40的输送设备的远端部分的放大透视图,其中鞘管撤回并且膨胀的瓣膜通过可释放连接被固定到输送设备。
图50是相似于图49的输送设备的远端的放大透视图,但示出在瓣膜和输送设备之间形成可释放连接的可替换技术。
图51是相似于图49的输送设备的远端的放大透视图,但示出在瓣膜和输送设备之间形成可释放连接的另一技术。
图52A和图52B是根据另一实施例的输送设备的远端部分的剖面图。
图53A是根据另一实施例的输送设备远端部分的剖面图。
图53B是图53A的一部分的放大图,示出在瓣膜支架和输送设备的远端之间的连接。
图53C是图53A的输送设备的透视图。
图53D和图53E图解从图53A中示出的输送设备展开的瓣膜。
图54A是根据另一实施例的人工瓣膜的输送设备的透视图,示出其中输送设备的鞘管在撤回位置以便展开瓣膜。
图54B是图54A的输送设备的透视图,示出其中鞘管在远端位置以便在瓣膜输送期间覆盖瓣膜。
图54C是图54A的输送设备的端部件和在端部件中各凹处内接收的瓣膜支架的三个支柱的放大透视图。
图54D是在图54C中示出的端部件的剖面图。
图55A和图55B是可与导引器鞘管一起使用以便导引输送设备到身体内的装载器件的实施例的剖面图。
图56A和图56B是装载器件另一实施例的剖面图。
图57A和图57B是根据一个实施例的导引器鞘管和装载器组件的剖面图。
图58A是根据另一实施例的导引器鞘管的透视图。
图58B是图58A的导引器鞘管的套管的放大透视图。
图59是可与图58A的导引器鞘管一起使用的套管的另一实施例的放大透视图。
图60是可与图58A的导引器鞘管一起使用的套管的端视图。
具体实施方式
首先参考图1,示出根据一个实施例的人工主动脉心脏瓣膜10。瓣膜10包括支持柔性瓣叶段14的可膨胀框架构件或支架12。瓣膜10径向可压缩到压缩状态,以便输送通过身体到展开部位并且在展开部位可膨胀到在图1中示出的其功能性尺寸。在某些实施例中,瓣膜10自膨胀;即,瓣膜在从输送鞘管的远端前进时可径向膨胀到其功能性尺寸。特别适合经皮输送和移植自膨胀瓣膜的设备在下面被详细描述。在其它实施例中,瓣膜可以是适合以压缩状态被安装在输送导管的球囊上的球囊可膨胀瓣膜。如本领域中已知,可通过将球囊充气在展开部位使该瓣膜膨胀到其功能性尺寸。
图解的瓣膜10适合展开在自体主动脉环中,尽管它也可用来替换心脏的其它自体瓣膜。此外,瓣膜10可适合替换身体内其它瓣膜,例如静脉瓣膜。
图3和图4示出为图解目的没有瓣叶段14的支架12。如示出,支架12可由多个纵向延伸、大体正弦成形的框架构件或撑杆16形成。撑杆16形成为具有交替弯曲,并在由邻近弯曲的顶点形成的节点18处焊接或其他方式固定于彼此,以便形成网孔结构。撑杆16可由合适的形状记忆材料制作,例如称为Nitinol的镍钛合金,该形状记忆材料允许瓣膜压缩到减小的直径以便在输送设备(例如下面描述)中输送并然后导致瓣膜在从输送设备展开时在病人身体里面膨胀到其功能性尺寸。如果瓣膜是适合卷曲到输送设备的可充气球囊上并通过球囊充气而膨胀到其功能性尺寸的球囊可膨胀瓣膜,那么支架12可由合适的延性材料制作,例如不锈钢。
支架12具有流入端26和流出端27。撑杆16形成的网孔结构具有通常柱形的“上”或流出端部分20、向外俯曲或扩大的中间段22以及向内俯曲的“下”或流入端部分24。中间段22理想地尺寸和形状被制成延伸到在主动脉根部的Valsalva窦内,从而有助于一旦植入就锚固瓣膜就位。如示出,网孔结构理想地具有沿其全部长度的弯曲形状,该形状从流出端部分20向中间段22直径逐渐增加,然后从中间段22向流入端部分24上的位置直径逐渐减少,然后直径逐渐减少从而形成在流入端26终止的张开部分。
当瓣膜在它的收缩状态时,中间段22具有直径D1,流入端部分24具有最小直径D2,流入端26具有直径D3,以及流出端部分20具有直径D4,其中D2小于D1和D3,并且D4小于D2。另外,D1和D3理想地大于要移植瓣膜的自体环的直径。这样,支架12的全部形状有助于将瓣膜保持在移植部位。更特殊地,并参考图5A和图5B,瓣膜10可植入自体瓣膜内(在图解例子中的主动脉瓣膜),以使下段24安置在主动脉环28内,中间段24在主动脉环24上方延伸到Valsalva窦56内,并且下张开端26在主动脉环下方延伸。通过下段24抵抗主动脉环28周围组织和支架几何形状的径向向外力,瓣膜10保持在自体瓣膜内。特殊地,中间段24和张开的下端26径向向外延伸超过主动脉环28,从而更好地抵抗沿向上游和下游方向(朝向和远离主动脉)的瓣膜的轴向移位。取决于自体瓣叶58的条件,瓣膜通常展开在自体环28内,其中自体瓣叶58向上折叠并被压缩在支架12的外表面和Valsalva窦的壁之间,如在图5B中示出。在一些情况下,理想的是在移植瓣膜10之前切除瓣叶58。
具有自膨胀框架的已知人工瓣膜通常具有延伸到脉管系统非患病区域内且固定于此的额外锚固器件或框架部分。因为支架12的形状有助于保持瓣膜,所以不需要额外锚固器件,并且支架的全部长度L可最小化从而防止支架上部分20延伸到主动脉的非患病区域内,或从而至少最小化上部分20延伸到主动脉的非患病区域内的程度。避开病人脉管系统的非患病区域有助于避免需要未来干预的情况下的并发症。例如,人工瓣膜可更容易从病人移除,因为支架主要锚固到瓣膜的患病部分。
在具体实施例中,对于意图在22-mm到24-mm环中使用的瓣膜而言,直径D1为大约28mm到大约32mm,其中30mm为具体例子;直径D2为大约24mm到大约28mm,其中26mm为具体例子;直径D3为大约28mm到大约32mm,其中30mm为具体例子;以及直径D4为大约24mm到大约28mm,其中26mm为具体例子。在具体实施例中长度L为大约20mm到大约24mm,其中22mm为具体例子。
参考图1,支架12具有从支架上部分20延伸的支柱30(在图解实施例中为三个)形式的多个成角度隔开的保持臂或突起(projection)。每个保持臂30都具有尺寸上接收可用来在瓣膜和输送设备(下面描述)之间形成可释放连接的瓣膜保持机构的尖头的相应孔径32。在可替换实施例中,如果不使用瓣膜保持机构,那么不需要提供保持臂30。
如在图6和图7中最优示出,在图解实施例中的瓣叶组件14包含柔性材料制作的三个瓣叶34a、34b和34c。每个瓣叶都具有流入端部分60和流出端部分62。瓣叶可包含任何合适的生物材料(例如,心包组织,例如牛或马心包)、生物相容合成材料或其它这样的材料,例如在作为参考包括在此的美国专利No.6730118中描述的材料。瓣叶组件14可包括在邻近瓣膜流入端的缝合线44处被固定到瓣叶34a、34b和34c流入端部分外表面的环增强裙缘42。可通过将裙缘42缝合到支架下段24的撑杆16而将瓣叶组件14的流入端部分固定到支架12(在图1中最优示出)。如在图7中示出,瓣叶组件14可进一步包括固定到瓣叶的流入端部分60内表面的内增强带46。
参考图1和图2,瓣叶组件14的流出端部分可在瓣叶34a、34b和34c的三个成角度隔开的连合附连部处被固定到支架12的上部分。如在图2中最优示出,可通过在两个瓣叶的连合处围绕邻近上边缘部分38缠绕增强段36并用缝线48将增强段36固定到边缘部分38,从而形成各连合附连部。然后可用缝线50邻近支架流出端将增强材料和瓣叶的夹层固定到支架的撑杆16。因此瓣叶从流入端26向流出端27理想地延伸支架的全部长度或基本全部长度。增强段36增强到瓣叶与支架的附连,以便最小化在缝合线处的应力集中,并避免在使用期间柔曲的瓣叶部分上的“针眼”。增强段36、裙缘42和内增强带46理想地由生物相容合成材料制作,例如聚四氟乙烯(PTFE),或由织物材料制作,例如织涤纶(例如,聚对苯二甲酸乙二醇酯(PET))。
图7示出瓣膜10的操作。在舒张期间,瓣叶34a、34b和34c塌陷从而有效关闭瓣膜。如示出,支架12的中间段22的弯曲形状限定在中间段和瓣叶之间的空间来模仿Valsalva窦。因此,在瓣叶关闭时,进入“窦”的逆流沿瓣叶的上表面产生血液的湍流,如通过箭头52表示。该湍流有助于清洗瓣叶和裙缘42,从而最小化凝块形成。
瓣膜10可以以倒退/逆行方式被移植,其中以卷曲状态安装在输送设备远端的瓣膜经股动脉被导引到身体内并前进通过主动脉弓到达心脏,如在作为参考包括在此的美国专利公开No.2008/0065011中进一步描述。
图8示出根据一个实施例的可用来输送自膨胀瓣膜,例如上面描述的瓣膜10,使其通过病人脉管系统的输送设备100。输送设备100包含具有细长轴104的第一最外或主导管102,主导管102的远端耦合到输送鞘管106(也称为输送柱)。主导管102的近端连接到输送设备的把手(未示出)。在输送瓣膜期间,可由外科医生使用把手使得输送设备通过病人脉管系统前进和撤回。尽管不需要,但主导管102可包含引导导管,其被配置成允许外科医生在轴104远端部分前进通过病人脉管系统时引导或控制轴104的远端部分弯曲或柔曲的量,例如在美国专利公开No.2008/0065011中公开。
输送设备100也包括具有细长轴110(在此也称为转矩轴)的第二导管108(在此也称为瓣膜导管)、布置在轴110上的柱形螺钉112以及连接到轴110的远端部分116的瓣膜保持机构114。瓣膜导管108的轴110延伸通过输送鞘管106和主导管102的轴104。输送设备100也可包括具有细长轴120和固定到轴120远端部分的突头件(nose piece)122的第三突头导管118。突头件122可具有如示出的渐细外表面,以便无创伤跟踪通过病人脉管系统。突头导管的轴120延伸通过瓣膜10、保持机构114和瓣膜导管108的轴110。瓣膜导管108的转矩轴110可经配置相对于主导管的轴104和突头导管的轴120轴向可移动并可旋转。输送设备100也可具有可用来在输送鞘管106内部装载压缩状态的瓣膜10的装载锥体124,如在下面进一步描述。
瓣膜导管轴110的远端部分116可包括螺钉112安装在其上的端部件156。端部件156具有至少部分沿匹配螺钉112相似成形内表面的端部件长度延伸的非圆形剖面轮廓(如在图11中最优示出)。例如,在图解实施例中,端部件156的一部分具有与螺钉112的正方形成形内表面匹配的正方形剖面轮廓。这样,轴110的旋转导致螺钉112的对应旋转。
瓣膜导管108理想地被配置成相对于输送鞘管106可旋转,从而影响瓣膜10从输送鞘管的递增的和受控的前进。为此并根据一个实施例,输送鞘管106(如在图9-12中最优示出)可包括第一和第二细长凸轮槽126和适合啮合螺钉112的外螺纹132的内螺纹128。主导管轴104的远端部分延伸到输送导管106内,并可形成具有径向向外延伸到输送鞘管的凸轮槽126内的第一和第二突起130。
如在图11中最优示出,轴110的远端部分在端部件156的近端部分之上延伸并固定到端部件156的近端部分,例如用粘合剂固定。螺钉112布置在输送鞘管106内的端部件156上。螺钉112的远端和端部件56经保持机构114耦合到瓣膜10,以使瓣膜导管轴10的旋转有效导致端部件56、螺钉112和瓣膜10的对应旋转。轴110和螺钉112相对于鞘管106的旋转沿向近端或远端方向(如分别通过箭头134a和134b图解)相对于鞘管106纵向有效移动轴110和瓣膜10。在瓣膜展开期间,轴110沿向近端方向的移动导致瓣膜10从鞘管的开放远端前进,如在下面进一步描述。
如在图13和图14中最优示出,瓣膜保持机构114包括内叉138和外叉140。内叉138包括对应支架12的保持臂30的多个成角度隔开的尖头142(在图解实施例中为三个),该尖头从在内叉的近端处的头部144延伸。外叉140相似地包括对应支架12的保持臂30的多个成角度隔开的尖头146(在图解实施例中为三个),该尖头从在外叉的近端处的头部148延伸。
外叉的每个尖头都与内叉的对应尖头配合,从而形成与支架的保持臂30的可释放连接。在图解实施例中,例如,每个尖头146的远端部分都形成为具有开孔150。在装配时(如在图15中最优示出),支架的每个保持臂30都插入通过外叉的尖头146的开孔150,并且内叉的尖头142插入通过保持臂30的开孔32,以便使得保持臂30保持不退出开孔150。如可见,向近端撤回尖头142(在箭头152的方向上)从而从开孔32移除尖头有效地从保持机构释放瓣膜10。这样,保持机构114形成与被足够固定以相对瓣膜导管108保持瓣膜的瓣膜之间的可释放连接,从而允许用户在瓣膜从输送鞘管展开之后良好调节或调整瓣膜的位置。当瓣膜安置在所需移植部位时,可通过相对于外叉140撤回内叉138来释放在瓣膜和保持机构之间的连接,如在下面进一步描述。
内叉的头部144可连接到瓣膜导管轴110,而头部148可连接到螺钉112。如在图13中示出,例如,内叉的头部144可形成具有多个成角度隔开的、向内偏置的保持凸缘154。瓣膜导管轴110的端部件156可形成具有柱形轴158,柱形轴158具有环形槽160。轴158具有稍微大于通过凸缘154的内自由端所限定的直径的外直径。因此,可通过将轴158插入头部144内直到凸缘154向内柔曲到沟槽160来将内叉138固定到端部件156,由此在头部144和轴158之间形成卡扣配合连接。如在图16中可见,在头部144插入轴158上的时候,在沟槽160内的环状轴肩162与凸缘154的自由端相对安置,并且端部件156的另一环状轴肩164与头部144的近端相对安置,从而防止端部件156相对于内叉沿向远端和近端方向纵向移动。
外叉的头部148可用相似方式固定到螺钉112的远端。如在图16中最优示出,头部148可形成具有多个成角度隔开的、向内偏置的保持凸缘155。螺钉112的远端部分可形成具有柱形轴166,柱形轴166具有环形沟槽168。轴166具有稍微大于由凸缘155的自由端所限定的直径的外直径。因此,可通过将轴166插入到头部148内直到凸缘向内柔曲到沟槽168内来将外叉140固定到螺钉112,由此在头部148和轴166之间形成卡扣配合连接。如在图16中可见,在头部148插入轴166上的时候,在沟槽168内的环状轴肩170与凸缘156的自由端相对安置,并且螺钉112的另一环状轴肩172与头部的近端相对安置,从而防止螺钉相对于外叉沿向远端和近端方向纵向移动。
瓣膜10可以以下面方式使用装载锥体124被压缩和装载到输送鞘管106内。首先,如在图17中示出,瓣膜10可如上面描述被固定到保持机构114。装载锥体124包括在一个末端处的第一开孔176、在相反末端处的第二较小开孔178以及从在第一开孔处的第一直径逐渐减小到第二开孔178近端的第二较小直径的渐细内表面180。如在图18中示出,保持机构114和瓣膜10可在箭头174的方向上被推动通过装载锥体124,从而径向压缩保持构件和瓣膜直到保持构件114延伸到装载锥体之外。为促进瓣膜压缩,可在将瓣膜和保持机构浸没在冷水盆中的同时执行后面的步骤。
参考图19和图20,在通过装载锥体124将瓣膜保持在其压缩状态时,通过在如上面描述沿箭头182的方向将轴158插入内叉的头部144内,从而将端部件156固定到内叉。参考图21和图22,螺钉112之后可在箭头184的方向上在端部件156之上滑动,并通过如上面描述将轴166插入外叉的头部148内被固定到外叉140。随后,参考图23和图24,通过使得螺钉近端与鞘管106的远端接触且之后旋转瓣膜导管轴110,导致鞘管前进越过螺钉,从而将输送鞘管106放置在螺钉112之上。轴110的连续旋转导致鞘管106在保持构件114和瓣膜10之上前进,并然后推走装载锥体,从而允许鞘管在离开装载锥体时在瓣膜之上前进。轴110旋转直到瓣膜完全在鞘管内部,如在图9和图11中示出。
在使用突头锥体122时,突头锥体理想地具有小于装载锥体的开孔178的外直径,以便突头锥体可连同瓣膜10滑过装载锥体。在可替换实施例中,传统卷曲机构可用来径向压缩瓣膜10。
一旦在输送鞘管106中装载瓣膜10,则输送设备100可被插入到病人身体内,以便输送瓣膜。在一个方法中,瓣膜可在倒退过程中被输送,其中输送设备被插入到股动脉中,并前进通过病人脉管系统到达心脏。在插入输送设备之前,导引器鞘管可被插入到股动脉中,跟随其的是前进通过病人脉管系统通过主动脉并进入左心室的引导线。输送设备100之后可被插入通过导引器鞘管,并在引导线之上前进直到含有瓣膜10的输送设备的远端部分前进到邻近自体主动脉瓣膜或在该瓣膜内的位置。
此后,可通过使得瓣膜导管108相对于引导导管102旋转从而从输送设备100展开瓣膜10。如上面提及,瓣膜导管可具有可旋转把手部分(未示出),其被连接到瓣膜导管轴110的近端,这允许外科医生有效地相对于主导管102旋转瓣膜导管108。瓣膜导管108的旋转导致瓣膜导管轴110、端部件156和螺钉112相对于主导管轴104和鞘管的对应旋转,这又导致这些部件相对于输送鞘管106向远端前进,从而使得瓣膜10从鞘管的开口端前进。瓣膜导管108的旋转导致在瓣膜从输送鞘管的开放远端前进并开始膨胀时瓣膜以精确且受控的方式相对于鞘管移动。因此,不同于已知输送设备,在瓣膜开始从输送鞘管前进并膨胀时,瓣膜被保持成抵抗离开鞘管的不受控运动,该运动是由于抵抗鞘管远端施加的瓣膜的膨胀力而导致的。另外,在瓣膜从鞘管部分前进之后,可理想地将瓣膜撤回到鞘管内,例如为了重新定位瓣膜或为了从身体整个抽回瓣膜。部分展开的瓣膜可通过逆向旋转瓣膜导管而撤回到鞘管内,该逆向旋转导致导管轴110撤回并将瓣膜拉回到鞘管内。
在已知输送器件中,外科医生必须向轴和/或鞘管施加推-拉力,从而使瓣膜出鞘。因此难以将力传到器件的远端而不扭曲轴(例如,轴向压缩或伸展轴),这会导致在出鞘过程期间瓣膜的不受控制运动。为减轻该效果,轴和/或鞘管可被制作得更具有刚性,而这是不理想的因为器件会变得更难以操作来通过脉管系统。相反,上面描述的将瓣膜出鞘的方法消除了公知器件中所需要的在轴上施加推-拉力,因此相对大且精确的力可施加到轴的远端而不危害器件的柔性。在某些实施例中,差不多20lbs.的力可传递到转矩轴末端而不会不利地影响出鞘过程。相反,在出鞘过程期间利用推-拉机构的现有技术器件通常不可能具有超过大约5lbs.的力。
在瓣膜10从输送鞘管前进并膨胀到其功能性尺寸之后(如在图10中示出),瓣膜仍经由保持机构114被连接到输送设备。因此,在瓣膜从输送鞘管前进之后,外科医生可相对于自体瓣膜中的理想移植位置重新定位瓣膜,例如通过沿向近端或远端方向或并排地移动输送设备,或旋转输送设备,这导致瓣膜的对应移动。保持机构114理想地提供在瓣膜和输送设备之间的连接,该连接足够固定和刚性从而在相对于自体瓣膜中的理想移植位置调整瓣膜位置时,抵抗血液流动来保持瓣膜相对于输送设备的位置。一旦外科医生将瓣膜安置在自体瓣膜中的理想移植位置,那么可通过相对于引导导管沿向近端方向撤回瓣膜导管轴110来释放在瓣膜和输送设备之间的连接,其中上述撤回有效地撤回了内叉138从而从瓣膜的保持臂30中的开孔32抽回其尖头142(图26和图27)。输送设备的撤回导致撤回外叉140,从而从保持机构114完全断开瓣膜(图28)。此后,输送设备可从身体抽回,留下瓣膜被移植在自体瓣膜内(如在图5A和图5B中示出)。
在可替换实施例中,输送设备可适合输送球囊可膨胀人工瓣膜。如上面描述,保持机构114可用来将瓣膜固定到输送设备末端。由于瓣膜的支架不是自膨胀的,因此鞘管106可以是可选的。保持机构114增强了输送设备和瓣膜组件通过导引器鞘管的可推动性。
图29A示出根据另一实施例的输送设备200的远端部分。输送设备200具有相似于输送设备100的构造,并具有与输送设备100相同的许多部件(为清晰共同部件中的一些从图29A移除)。输送设备200包含细长瓣膜导管202。瓣膜导管202包含细长柔性转矩轴204、固定到轴204远端的端部件206以及在转矩轴204外层/之外/之上(over)的外轴220。
输送鞘管208被固定到外轴220的远端。输送鞘管208被布置在轴204的远端部分、端部件206、瓣膜保持机构114以及在鞘管内部保持压缩状态的瓣膜10之上。仅保持机构114的外叉140在图29A中示出。外叉140的头部148可固定到端部件206,例如通过形成与例如上面描述的端部件的阶梯状轴部分210的卡扣配合连接。内叉138(没有在图29A中示出)可在它的头部144连接到延伸通过瓣膜导管轴的内轴的远端(没有在图29A中示出)。内轴可以是细长突头导管118的轴120(图8)。内叉138的尖头142延伸通过支架12中的开孔32,从而将瓣膜10固定到输送设备,如上面详细描述。因为内叉138被固定到延伸通过轴204的内轴,所以通过相对于轴204沿朝近端方向撤回内轴,来相对于外叉140撤回内叉138,从而从支架中的开孔抽回内叉的尖头(并由此释放瓣膜10)。
在图解配置中的轴204包含第一层212和第二层214,第一层212包含柔性开槽管,第二层214包含围绕第一层212螺旋缠绕的线圈。第一层212可由金属(例如,不锈钢)、聚合材料或其他合适材料制作。线圈214可以是例如不锈钢线,尽管可使用其它材料。线圈214至少沿轴204的远端部分延伸,并啮合鞘管208的内螺纹216。这样,线圈214充当轴204的外螺纹。在相对于外轴220旋转转矩轴204时,通过外轴220,鞘管208保持抵抗随轴204旋转,因此轴204的旋转导致轴204相对于鞘管208向远端前进从而展开瓣膜10。
使用中,输送设备200被插入到病人脉管系统内,并前进到心脏中的移植部位。转矩轴204然后相对于外轴220旋转,从而导致轴向远端前进(如通过箭头218表示)直到瓣膜10出鞘并膨胀到其功能性尺寸。在这点上,瓣膜10通过保持机构114保持连接到输送设备,因此用户可精密地调节膨胀瓣膜在移植部位的位置。一旦瓣膜在所需取向上,那么可通过撤回内轴来释放由保持机构114形成的连接,如上面描述。此后,保持机构可撤回到鞘管内,并且全部输送设备可从身体移除。
图29B示出根据另一实施例的输送设备250的远端部分。输送设备250具有相似于输送设备100的构造,并具有与输送设备100相同的许多部件(为清晰共同部件中的一些从图29B移除)。输送设备250包含细长瓣膜导管252,细长瓣膜导管252包含延伸到输送鞘管256内的细长柔性转矩轴254。轴254可包含例如示出的盘绕轴或线缆(例如不锈钢线缆)。第一螺钉构件258布置在鞘管内的轴254的远端部分上并固定于此,并且第二螺钉构件260布置在鞘管内的第一螺钉构件上。第一螺钉构件258具有啮合第二螺钉构件260的内螺纹的外螺纹。第二螺钉构件260也具有啮合鞘管256内螺纹的外螺纹。
输送设备可进一步包括外轴264,其在轴254之上延伸并具有固定到鞘管256近端的远端部分。转矩轴254可相对于外轴264和鞘管256旋转,从而导致转矩轴相对于鞘管纵向前进,以便从鞘管展开瓣膜。圈环构件266安装在转矩轴254的外表面上,并且在转矩轴旋转时与转矩轴一起相对于外轴264纵向移动。圈环构件266被安置成在转矩轴254向远端前进一预定距离后接触第二螺钉构件260并导致第二螺钉构件260在鞘管256内前进,如下面进一步描述。
如在图29B中进一步示出,瓣膜保持机构114的外叉140可在它的头部148被固定到第一螺钉构件258的阶梯状轴部分262,其又依次固定到转矩轴254。内叉138(没有在图29B中示出)可在它的头部处连接到延伸通过转矩轴254的内轴的远端(未示出)。内叉的尖头从轴254的远端延伸,并与外叉的尖头配合,从而形成与支架的支柱30的可释放连接,如上面描述。内叉可相对于外叉撤回,从而通过相对于转矩轴254撤回内轴来释放与支柱30的连接。
使用中,输送设备250插入到病人脉管系统内,并前进到心脏中的移植部位。为开始展开瓣膜,转矩轴254相对于外轴264旋转,导致第一螺钉构件258旋转并相对于第二螺钉构件260和鞘管258向远端前进(在箭头268的方向上),从而使得瓣膜10部分地前进离开鞘管的远端。在转矩轴254前进一预定距离之后,圈环构件266接触第二螺钉构件260,因此转矩轴254的进一步旋转有效地导致第一螺钉构件和第二螺钉构件相对于鞘管向远端前进,从而使得瓣膜10完全地前进离开鞘管。一旦瓣膜在所需取向上,那么通过保持机构114形成的连接可通过撤回内轴而被释放,如上面描述。此后,保持机构可被撤回到鞘管内,并且可从身体移除全部输送设备。
图30-37图解根据另一实施例的输送设备300。图30-33示出输送设备300的远端部分。图34-35示出输送设备300的近端部分。图36-37示出从输送设备300展开瓣膜10(为在图中清晰移除瓣膜的瓣叶)。
输送设备300包含具有在设备远端处的瓣膜保持机构306(图32和图33)和设备近端处的把手部分308(图34和图35)之间延伸的细长轴304的第一外导管302。主导管轴304的远端耦合到瓣膜保持机构306,该瓣膜保持机构306又固定到瓣膜10。外导管302可以是引导导管,其被配置成容许轴304的一部分选择性弯曲或柔曲,从而促进输送设备前进通过病人脉管系统。
输送设备也包括第二转矩导管310,其具有延伸通过主导管轴304的细长转矩轴312。转矩轴304的远端连接到柔性螺钉机构314,柔性螺钉机构314包含延伸通过保持机构306的柔性轴316以及沿轴316的长度分隔开的一个或更多个螺钉构件318(图32和图33)。如在图33中示出,螺钉机构314的轴316展现充分柔性,从而容许弯曲或柔曲,从而有助于跟踪输送设备通过病人脉管系统。主导管轴304可形成为具有啮合螺钉构件318的外螺纹的内螺纹。例如,主轴304的远端部分(例如,在轴304的远端部分处的11-mm段)可形成为具有内螺纹。转矩轴312的近端部分延伸到把手部分308内,在此它耦合到控制旋钮320,从而容许相对于主导管轴304旋转转矩轴(图34和图35),如在下面进一步描述。
操作中,每个螺钉构件318穿过并啮合主轴304的内螺纹部分。螺钉构件318理想地相互隔开,以便在螺钉构件穿过内螺纹部分时,在螺钉构件318啮合主轴304内螺纹部分的一个末端之后,在相邻螺钉构件318能够脱离主轴304内螺纹部分的另一末端,以便防止或至少最小化在转矩轴上施加的轴向指向的力。这样,相对大的出鞘力可施加到鞘管上而不危害输送设备的整体柔性。
输送设备也可包括第三突头导管324,其具有细长轴326,该细长轴326在其远端连接到突头件328。突头导管轴326延伸通过转矩轴312,并具有从把手部分308的近端向外延伸的近端部分(图34和图35)。主导管轴304、转矩轴312和突头导管轴326理想地被配置成相对于相互轴向可移动。
如在图30和图31中示出,输送设备可进一步包括在压缩瓣膜10之上延伸的可移动鞘管322。鞘管322连接到螺钉机构314,以便转矩轴312和螺钉机构314的纵向移动导致鞘管322的对应纵向移动。例如,鞘管可具有延伸到指形件362的相应孔隙360(图32)内的向内延伸的尖头358(图31),孔隙360又连接到柔性轴316的远端。在轴316分别向远端或向近端移动时,指形件362通过推动或拉动指形件362的回转接头而被理想地连接到轴316,仍允许轴316相对于指形件362旋转。因此,转矩轴312和螺钉机构314相对于主轴304的旋转有效地导致鞘管322相对于瓣膜向近端和远端方向移动(如在图30中通过双头箭头330表示),从而容许瓣膜从鞘管受控的展开,如下面进一步描述。
参考图32和图33,瓣膜保持机构306包含外叉330和内叉332。指形件362的一部分在图33中切除从而示出内叉332。外叉330包含头部334和从头部334延伸的多个细长柔性尖头336(在图解实施例中为三个)。头部334可形成为具有弹性保持凸缘338,从而容许外叉与主导管轴304的阶梯状轴部分形成卡扣配合连接,如上面描述。内叉332具有牢固地固定到突头导管轴326的头部340和从头部延伸的多个细长尖头342。外叉的尖头336的远端部分可形成为具有依尺寸接收瓣膜10的相应保持臂30的孔隙344。内叉332的尖头342的远端延伸通过保持臂30中孔隙32,从而形成可释放连接以便固定瓣膜10,相似于在上面描述并在图14-16中示出的瓣膜保持机构114。在瓣膜从鞘管322展开之后,可通过将突头导管轴326相对于主导管轴304撤回,从而从保持臂30中的孔隙32抽回尖头342,从而释放在瓣膜和保持机构306之间的连接。外尖头336和螺钉机构314的轴316展现充分柔性从而允许输送设备的一部分在输送设备前进通过病人脉管系统到移植部位时弯曲或柔曲,但仍足够坚硬从而容许在瓣膜从鞘管322展开之后重新定位瓣膜。包括尖头336的外叉330可由提供理想柔性的各种合适材料中的任何材料制造,例如金属(例如,不锈钢)或聚合物。
参考图34和图35,把手部分308包含容纳第一齿轮348和第二齿轮350的外壳346。第一齿轮348具有延伸通过外壳并连接到设置在外壳的外侧上的控制旋钮320的轴。第二齿轮350布置在转矩轴312上并牢固地固定到转矩轴312。因此,控制旋钮320的人工旋转导致第一齿轮348旋转,这又旋转了第二齿轮350。第二齿轮350使得转矩轴312和螺钉机构314相对于主导管轴304、瓣膜保持机构306和瓣膜10旋转。转矩轴312和螺钉机构314的旋转又导致鞘管322相对于瓣膜的线性移动。
使用中,瓣膜10以例如可通过使用在上面描述的装载锥体124所实现的径向压缩状态被装载到鞘管322内(如在图30中示出)。输送设备300然后插入病人脉管系统内,并前进到在移植部位处或邻近移植部位的位置。然后瓣膜10可通过旋转在把手部分上的旋钮320而从鞘管展开,其中旋转旋钮320又导致转矩轴312和螺钉机构316在主轴304内撤回,从而导致鞘管322沿向近端方向(在图31中箭头352)移动,从而暴露瓣膜,如在图31中示出。旋钮320的旋转使在瓣膜展开期间能够受控且精确地撤回鞘管322。有利地,在出鞘过程期间鞘管撤回的同时瓣膜的位置能够相对于在移植部位处的环而保持恒定。旋钮在相反方向上的旋转导致鞘管沿向远端方向移动从而再次覆盖瓣膜。因此,在瓣膜已经从鞘管至少部分前进出之后,如果需要在体内重新定位输送设备或从身体完全抽回输送设备和瓣膜,那么可以逆向旋转旋钮,从而使得瓣膜以压缩状态回到鞘管内。
在瓣膜10已经从输送鞘管前进出并膨胀到其功能性尺寸之后(如在图36中示出),瓣膜仍经保持机构306连接到输送设备。因此,在瓣膜从输送鞘管前进出之后,外科医生可将瓣膜相对于自体瓣膜中所需移植部位重新定位,例如通过沿向近端和远端方向或并排移动输送设备,或旋转输送设备,从而导致瓣膜的对应移动。保持机构306理想提供瓣膜和输送设备之间的连接,该连接足够牢固和刚性从而在瓣膜位置相对于自体瓣膜中所需移植部位被调整时抵抗血液流动保持瓣膜相对于输送设备的位置。一旦外科医生将瓣膜定位在自体瓣膜中所需移植部位,那么外科医生可通过相对于主导管轴304沿向近端方向(如在图34中通过箭头356表示)拉动突头导管轴326的近端354,而有效地撤回内叉332从而将它的尖头342从瓣膜的保持臂30中的开孔32抽回(图37),从而释放在瓣膜和输送设备之间的连接。撤回主导管轴304导致撤回外叉330,从而从保持机构306完全断开瓣膜(如在图37中示出)。此后,保持机构可撤回到鞘管322内,输送设备可从身体抽回,留下移植在自体瓣膜内的瓣膜(例如在图5A和图5B中示出)。
如果外科医生在瓣膜10从鞘管完全展开但仍连接到保持机构306之后决定中止过程,那么不可能将膨胀的瓣膜收回到鞘管内。为此,图38A-38C示出可与输送设备300一起使用从而有助于将膨胀的瓣膜10收回到鞘管322内的瓣膜收回器件400的实施例。在图解实施例中的瓣膜收回器件400包含细长的大体柱形的主体,其被配置成插入病人脉管系统内并在主导管轴304之上前进。主体的远端部分包含多个细长的柔性翼瓣(flap)部分402,翼瓣部分402通常保持在压缩状态,通常为圆柱体(如在图38A中示出)形式,并可相对于彼此径向向外柔曲,从而形成足够大从而接收膨胀的瓣膜10近端的大体锥体形容器(图38B和图38C)。理想地防止翼瓣部分402膨胀超过在图38B和图38C中示出的膨胀状态。另外,翼瓣部分402理想地尺寸被形成为在圆周方向上相互交叠,因此在翼瓣部分膨胀时,它们形成具有在翼瓣部分之间没有任何缝隙的连续外表面的圆锥体。为影响翼瓣部分402的膨胀,每个翼瓣部分都可连接到沿收回器件400的长度延伸到其近端的相应拉线。在张力施加到拉线的近端时,导致翼瓣部分相对彼此径向向外柔曲。另外,翼瓣部分402可由网孔材料或穿孔材料制作,例如穿孔箔,从而允许在收回过程期间血液流过翼瓣部分。
可替换地,翼瓣部分402可由形状记忆材料,例如Nitinol制作,并且是自膨胀的。自膨胀翼瓣部分一般采用在图38A-38B中示出的膨胀配置。翼瓣部分402可通过外鞘管406被保持在压缩状态(图38A)。当鞘管406在箭头408的方向上相对于翼瓣部分402撤回时,翼瓣部分402膨胀到在图38A-38B中示出的膨胀配置。
如上面提及,回收器件400可用来回收完全膨胀的瓣膜,并从病人身体移除它。使用中,回收器件400在主导管轴304之上被插入到身体内,并向展开的瓣膜10前进,如在图38A中示出。如在图38B和图38C中示出,翼瓣部分402然后膨胀并沿向远端方向进一步前进从而啮合瓣膜。在收回器件在瓣膜之上前进时,导致瓣膜压缩。在瓣膜压缩到足够小的直径从而容许被再次插入到鞘管322内时,鞘管322沿向远端方向前进(例如,通过旋转旋钮320)直到鞘管延伸在瓣膜之上。一旦瓣膜在鞘管内部,那么可从病人身体移除收回器件,继之以输送设备和瓣膜。
在某些实施例中,收回器件400的细长主体的一部分可具有适合啮合螺钉构件318螺纹(图32)的内螺纹,因此收回器件可通过旋转旋钮320(图34)而沿向远端和近端方向移动。使用中,收回器件插入到身体内,并在主导管轴304之上前进,直到收回器件的螺纹部分啮合螺钉构件318。翼瓣部分402然后膨胀并且收回器件和鞘管通过旋转旋钮320而在膨胀的瓣膜之上前进。翼瓣部分402的远端延伸经过鞘管322的远端,因此在两者前进时,瓣膜的近端首先与翼瓣部分接触,并开始压缩从而促进瓣膜插入鞘管内。
图39图解输送设备300的修改。在该实施例中,瓣膜10在从鞘管322展开之后通过抑制器件(例如环绕瓣膜的一个或更多可释放条带370)被保持在压缩状态。可通过拉动或移动允许条带打开并且瓣膜膨胀的圈套器件来释放条带370。可替换地,条带370可由在瓣膜前进到移植部位之后在体内分解的生物可吸收或可溶解材料制作。因为瓣膜在从鞘管前进时保持在压缩状态,所以可以避免瓣膜从鞘管末端“跳脱”的问题,从而允许瓣膜更受控的输送。如果使用条带370或相似抑制器件,那么输送设备可采用可操作从而推动瓣膜通过鞘管的传统推进轴,并且不需要包括经旋转来影响从鞘管展开瓣膜的可旋转转矩轴。即,条带370或相似抑制器件可与传统输送设备一起使用,其中操作员推动轴从而从鞘管推动瓣膜。此外,在一些实施例中,由于抑制器件可使得瓣膜在前进通过病人脉管系统到移植部位时保持在它的压缩状态,因此输送设备不需要包括在输送期间覆盖压缩瓣膜的鞘管。
图40图解根据另一实施例的输送设备400。输送设备400包括具有细长轴404的第一最外或主导管402,细长轴404的远端耦合到输送鞘管406,该输送鞘管406的尺寸被制成在瓣膜输送期间在人工瓣膜10之上延伸并将人工瓣膜10保持在压缩状态。轴404的近端连接到输送设备的把手组件408。输送设备也包括具有延伸通过轴404的细长轴412的第二导管410(也称为瓣膜导管)。输送设备也可包括具有细长轴416和固定到轴416远端部分的突头件418的第三突头导管414。突头导管轴416延伸通过瓣膜导管轴412,并可包括内腔以便接收引导线。轴404、412和416理想地被配置成沿向远端和近端方向相对于彼此可轴向移动。
如在图46中最优示出,突头件418可具有无创伤跟踪输送设备通过病人脉管系统的渐细远端部分,以及延伸到鞘管406内的渐细近端部分。在展开瓣膜后,突头件的渐细近端部分允许突头件418更容易插回到鞘管406内,以便从身体抽回输送设备。鞘管406可包括不透辐射的尖部490,从而帮助操作员将突头件撤回到鞘管内。
如在图48中最优示出,瓣膜导管轴412可具有一个或更多内腔492,以便导引造影剂(例如射线照相造影液)到围绕瓣膜的空间内的鞘管406内。鞘管406可具有一个或更多孔隙494(图46和图48),以便注射造影剂到病人脉管系统内。把手组件408可具有与内腔492流体连通的分离入口,以便导引造影剂到内腔内。造影剂可在展开人工瓣膜之前注射到邻近自体瓣膜的病人脉管系统内,从而有助于识别移植人工瓣膜的所需位置。例如,在替换主动脉瓣膜时,造影剂可注射到恰邻近自体瓣叶底部的主动脉内。这向操作员提供视觉反馈,从而为展开人工瓣膜帮助识别所需位置。在移植人工瓣膜之后,额外造影剂可邻近人工瓣膜的瓣叶直接注射,从而为人工瓣膜操作员提供视觉反馈。
在特别实施例中,鞘管406的内直径为大约0.265英寸或更小,并且鞘管406的外直径为大约0.28英寸或更小。
参考图41,在图解配置中的把手组件包括容纳轴404、412和416以及螺钉轴422的近端部分的外壳420。螺钉轴422被安装成在细长载体棒424上外壳420内部纵向移动。可通过远端托架426支持载体棒424的远端并且可通过近端托架428支持载体棒的近端。主轴404的近端可固定到短轴430,该短轴430例如通过粘结又被固定到螺钉轴422的内部。螺钉轴422可操作连接到致动器或控制旋钮432,其又可操作以控制在旋钮旋转时螺钉轴422和主轴404的纵向移动,如在下面进一步描述。把手组件408可进一步包括安装在它的近端的控制器470。控制器470具有与突头导管轴416的内腔流体连通的第一通道472,以便引导线插入通过轴416。连接器470可具有释放线506的近端部分延伸通过的第二通道474(在下面描述)。
如在图42中最优示出,把手组件408的外壳420可包含近端外壳部分434和远端外壳部分436。近端外壳部分434可包含第一和第二外壳部分434a、434b,并且远端外壳部分436可包含第一和第二外壳部分436a、436b。螺钉轴422可包括延伸通过第二外壳部分436b中槽464的冲刷部分(flush portion)462。冲刷部分462具有与主轴404和瓣膜导管轴412之间的空间流体连通的内腔,以便在轴之间导引冲刷流体。
控制旋钮432可包含旋钮部分438、延伸到近端外壳部分434内的近端延伸440和延伸到远端外壳部分436内的远端延伸442。如在图41中最优示出,在把手组件装配时,旋钮部分438安装在近端和远端外壳部分之间。近端外壳部分434可经延伸到近端延伸440中对应环沟槽446(图44)内的近端外壳部分的环凸缘444而被固定到近端延伸440。相似地,远端外壳部分可经延伸到远端延伸442的对应环沟槽450内的远端外壳部分的环凸缘448(图44)而被固定到远端延伸442。
控制旋钮432可包括安装在远端延伸442上的螺钉啮合闩锁452。螺钉啮合闩锁452可操作从而允许用户选择性啮合或脱离螺钉轴422,以便主轴104的相应精密或进程调整。进一步解释,螺钉啮合闩锁452(可包含第一和第二闩锁部分452a、452b)安装在控制旋钮的远端延伸442中形成的上和下槽454内。如在图45中最优示出,闩锁452具有延伸通过槽454并可啮合螺钉轴422的外螺纹的上和下向内延伸的凸缘456。闩锁452也形成为具有邻近凸缘456的弓形上和下内表面458。闩锁452在啮合位置和脱离位置之间沿横向方向上(如通过双头箭头460表示)在远端延伸442上可滑动,其中所述啮合位置处凸缘456延伸通过槽454并啮合螺钉轴422,所述脱离位置处曲面458对准在槽454内并且闩锁变得脱离螺钉轴422。弹簧466可布置在远端延伸442和闩锁部分452b之间,从而抵抗弹簧的偏置将闩锁452保持在啮合位置中。如在图43中最优示出,弹簧466的一个末端可保持在远端延伸442的侧面中的槽口468中,并且弹簧的另一末端可被安置成承载闩锁部分452b的内表面。
当闩锁在啮合位置中以使凸缘456啮合螺钉轴422的螺纹时,控制旋钮432的旋转导致螺钉轴422在外壳420内纵向移动。由于主轴404固定到螺钉轴422,因此螺钉轴的纵向移动导致主轴404和鞘管406相对于安装在瓣膜导管轴412远端的瓣膜的对应纵向移动。控制旋钮432的旋转有效地以准确且受控的方式使得鞘管406相对于瓣膜移动从而受控地展开瓣膜。在闩锁452移动到脱离位置以使曲面458对准在槽454中时,由于表面458所限定的内直径大于螺钉轴422的外直径,因此闩锁452变得从螺钉轴422脱离。在脱离位置中,主轴404可相对于控制旋钮432自由推动或拉动,以便鞘管406位置的进程调整。操作员可通过在主轴404从外壳420延伸的部分上推动或拉动,或通过在冲刷部分462(在槽464内移动)上推动或拉动,从而调整鞘管406的位置。
瓣膜导管轴412可包含经配置允许外科医生引导或控制输送设备远端部分的弯曲或柔曲量的引导导管,从而促进引导输送设备通过病人脉管系统。例如,参考图41和图42,把手组件408可包括可操作从而调整输送设备远端的弯曲或柔曲量的调整机构476。调整机构476可包括具有延伸到外壳420内的远端延伸480的可旋转调整旋钮478。远端延伸480具有孔洞,该孔洞形成为具有啮合滑动螺母482的内螺纹,该滑动螺母482被支持成在中心滑棒484上纵向移动。两个载体棒486在滑动螺母482的内表面和滑棒484的外表面之间延伸。每个载体棒486都被支持在滑棒484的外表面和滑动螺母482的内表面中的细长槽口中,以便约束滑动螺母482相对于调整旋钮478的旋转。借助于这种设置,旋钮478的旋转(顺时针或逆时针方向)导致滑动螺母482沿向远端和近端方向相对于滑棒484纵向移动。至少一根拉线(未示出)在它的近端固定到滑动螺母482,延伸通过把手组件和轴412,并且在它的远端固定在邻近轴412远端的位置。为增加输送设备远端部分的曲率,旋钮478旋转从而导致沿向近端方向移动滑动螺母482,这又拉动拉线从而增加输送设备的曲率。为减少输送设备的曲率,调整旋钮478在相反方向上旋转,从而沿向远端方向移动滑动螺母482,这减少了拉线内的张力,从而允许输送设备的远端部分在它自己的弹性下伸直。控制引导导管弯曲的调整机构的进一步详述在作为参考包括在此的美国专利公开No.2008/0065011和No.2007/0005131中公开。
现在参考图47-49,人工瓣膜10可经由可释放连接被固定到瓣膜导管轴412的远端,其中该可释放连接包含从瓣膜导管轴412的远端延伸的多个缝线500。每个缝线500都延伸通过瓣膜支架12的钩部分502(图49),并形成为具有释放线506延伸通过的环圈504。释放线506可延伸通过安装在突头导管轴416上的垫片508,从而维持释放线平行对准突头导管轴。释放线506进一步延伸通过瓣膜导管轴412、把手组件408和连接器470(图41)。如在图48中最优示出,缝线500可延伸通过瓣膜导管轴的尖部510中的孔隙,并相互打结或以其他方式固定到尖部510,从而相对于瓣膜导管轴固定缝线500。注意到没有示出全部瓣膜10;为图解目的在图49中仅示出瓣膜支架12。瓣膜10可具有相似于在图1-2中示出的瓣膜10的构造。
在瓣膜输送期间,瓣膜以径向压缩状态被安装在鞘管406内。为从鞘管406展开瓣膜,通过控制旋钮432的旋转(当闩锁452在啮合位置时)或通过沿向近端方向拉动主轴404(当闩锁452在脱离位置时),鞘管相对于瓣膜撤回。鞘管406的撤回露出瓣膜,该瓣膜延伸到其功能性尺寸且同时保持经缝线500连接到瓣膜导管轴412,如在图49中示出。由于瓣膜保持连接到瓣膜导管轴406,因此可通过移动输送设备的把手组件408来调整膨胀瓣膜的位置。一旦瓣膜在它移植的所需位置,那么可通过撤回释放线506从而从释放线释放缝线环504,由此从瓣膜的钩部分502释放缝线500,从而释放瓣膜。可通过在从把手上的连接器470延伸的释放线的近端上拉动来撤回释放线506(图41)。
图50示出在瓣膜和瓣膜导管轴412之间形成可释放连接的可替换连接技术。该实施例相似于在图48中示出的实施例,只是缝线500没有相对于尖部500被固定。相反,缝线的近端部分512牢固地固定到滑动释放机构(未示出),例如延伸通过瓣膜导管轴412的细长轴或线。在瓣膜通过缝线500连接到轴412时,释放机构可向远端移动,从而增加缝线500中垂度,从而容许瓣膜的钩部分502的受控膨胀。释放机构可以可操作连接到把手组件上的滑动或旋转旋钮,其可由用户操作从而影响释放机构的滑动移动。使用中,鞘管406相对于瓣膜撤回。这允许除钩部分502之外的支架12膨胀,该钩部分502由于它们仍连接到缝线500因此向内弯曲。在撤回释放线506之前,滑动释放机构向远端移动,从而增加缝线500中垂度,允许支架的钩部分502的受控径向膨胀。一旦支架完全膨胀,那么释放线506可撤回,从而从缝线500释放支架的钩部分502。
图51示出在瓣膜和瓣膜导管轴412之间形成可释放连接的连接技术的另一实施例。在该实施例中,多个绳索514(针对支架的每个钩部分502具有一个)从瓣膜导管轴412的远端延伸。每个绳索514的远端固定到相应附连元件516,该附连元件516通过缝线518连接到相应钩部分502。每个缝线518都具有牢固固定到附连元件516的一个末端,延伸通过钩部分502和附连元件中的开孔520,并在它的相反末端具有环圈521。对于每个绳索514和附连元件516,释放线522从轴412的远端延伸,并延伸通过相应缝线518的环圈521。绳索521的近端可固定到滑动释放机构,该滑动释放机构可向远端移动从而增加绳索514中垂度,从而容许在鞘管406撤回之后受控地径向膨胀支架的钩部分502从而从鞘管展开瓣膜。一旦支架完全膨胀,那么每个释放线522都可撤回从而释放相应缝线518,该缝线518然后被拉回通过开孔520从而释放钩部分502。每个释放线522都可独立撤回,例如通过在从把手组件408延伸的每个可释放线的近端上拉动。可替换地,每个释放线522都可连接到在可撤回或旋转从而一致地同时撤回释放线的把手组件上的公共旋钮。
图52A和图52B图解根据另一实施例的输送设备600的远端部分。输送设备600包括导管轴602,其在它的远端具有突头件604并具有接收自膨胀带支架瓣膜608的环形凹进部分606(在图52A和图52B中示意示出)。柔性外鞘管或套管610在导管轴602和瓣膜608之上延伸,并将瓣膜保持成在凹进部分606内处于压缩状态,以便输送通过病人脉管系统。覆盖瓣膜的鞘管610的远端部分是具有外折叠层612和内折叠层614的折叠部分。内折叠层614的近端616固定(例如,使用粘合剂)到导管轴602的外表面。使用中,如箭头618表示,可沿向近端方向拉动外折叠层612,从而揭露瓣膜并允许它膨胀,如在图52B中示出。套管610理想地展现充足刚性,从而抵抗瓣膜608的向外膨胀力,不过仍具有足够柔性从而允许外折叠层相对于内折叠层拉回。可选地,可在外折叠层612和内折叠层614之间形成薄流体层620,从而润滑和最小化折叠层的相邻表面之间的摩擦。输送设备600的优点是在套管拉回时没有摩擦力在套管610和瓣膜608之间生成,并且同样,用户需要较小力将瓣膜从它的压缩、装鞘状态中释放。
套管610可由各种材料中任何材料构造,包括各种聚合物(例如,尼龙或PTFE)或金属(例如,Nitinol)。套管可包含材料的一个或更多材料层,该层可以是例如编织层、网孔层、非穿孔层或其任何结合。尽管没有在图中示出,但套管610可延伸到输送设备的把手以便用户操纵。可替换地,套管610可以终止于未达到把手,并可连接到在套管近端和把手之间延伸的一根或更多拉线,该拉线可向近端被拉动从而拉回外折叠层以便展开瓣膜。
尽管突头件604示作导管轴602的一部分,但这不是必须的。在可替换实施例中,输送设备可包括延伸通过轴602并安装突头件604的内突头导管轴,如在上面实施例中描述。另外,在瓣膜和输送设备之间形成可释放连接的在此公开的各种连接机构中的任何连接机构均可被包括在图52A和图52B中示出的实施例中。此外,轴602可以是在轴的远端具有可充气球囊的球囊导管的轴,以便在球囊上安装球囊可膨胀瓣膜(在此情况下,瓣膜不需要自膨胀)。
图53A-53E图解根据另一实施例的输送设备700。输送设备700包含外导管轴702和延伸通过外轴的内导管轴704。外轴702的远端部分包含在人工带支架瓣膜706(示意示出)之上延伸并在输送通过病人脉管系统期间将它保持在压缩状态的鞘管。内轴704的远端部分成形为与一个或更多匹配延伸臂或支柱708向配合,其从瓣膜706的支架延伸从而在瓣膜和输送设备之间形成可释放连接。例如,在图解实施例中,每个支柱708都包含在圆环部分终结的笔直部分,并且轴704的远端部分具有接收相应支柱708的对应成形凹处710。每个凹处710都可包括经成形延伸到各支柱708中开孔714内的径向延伸的突起712。如在图53B中最优示出,每个凹处710和突起712都可成尺寸为在支柱708的表面和凹处内相邻表面之间提供小缝隙,从而促进在径向方向(即,垂直于轴704的轴)上从凹处插入或移除支柱。
在瓣膜706被装载到输送设备700内时,如在图53A中示出,以使瓣膜的每个支柱708都布置在凹处710中,借助于支柱和对应凹处形状,抵抗相对于轴704的轴向运动(沿向近端和远端方向)保持瓣膜。参考图53D,在撤回外轴702从而展开瓣膜706时,允许瓣膜膨胀但通过支柱和对应凹处所形成的以便瓣膜受控输送的连接来保持瓣膜抵抗从鞘管远端“跳出”。在该阶段,部分展开的瓣膜仍通过轴704保持,并可通过向近端相对于外鞘管702撤回轴704而被撤回到外鞘管702内。参考图53E,当沿向近端方向撤回外鞘管702使其超过支柱708时,瓣膜支架的膨胀力导致支柱从凹处710径向向外膨胀,由此从轴704完全释放瓣膜。
尽管在图解实施例中示出三个支柱708和对应凹处710,但可使用任何数量的支柱和凹处。此外,支柱和凹处可以是任何其它形状,例如正方形、椭圆形、矩形、三角形或其各种结合。支柱可由用来形成瓣膜支架的相同材料(例如,不锈钢或Nitinol)形成。可替换地,支柱可以是由较小刚性的材料(例如缝线材料)形成的环圈。环圈被固定到瓣膜支架,并且尺寸被制成被接收在凹处710中。
图54A-54D图解相似于在图53A-53E中示出的输送设备的输送设备800。输送设备800包括具有可旋转旋钮804的把手部分802、从把手部分802延伸的外导管轴806以及从把手部分802延伸并延伸通过外导管轴806的内导管轴808。内导管轴808的远端包括端部件810,其被形成为具有环形凹处812和多个轴向延伸、成角度隔开的凹处814。凹处812、814的尺寸和形状被制成接收从瓣膜的支架(没有在图54A-54D中示出)延伸的T形支柱816。每个支柱816都具有被接收在对应凹处814中的轴向延伸部分816a和被接收在环形凹处812中的横向末端部分816b。外轴806包括鞘管818,该鞘管的尺寸和形状被支撑在输送瓣膜期间在端部件812和瓣膜之上延伸。
外轴806可操作连接到旋钮804,从而影响在旋钮804旋转时外轴806和鞘管818相对于内轴808的纵向移动,例如结合在图40-42中示出的实施例在上面描述。使用中,瓣膜被安装成,通过在凹处812、814中放置瓣膜的支柱816并向远端移动鞘管使其在瓣膜之上延伸从而维持瓣膜在压缩状态,以用于输送。在移植瓣膜的目标部位处或在该部位附近,旋转旋钮804从而相对于瓣膜撤回鞘管818。在撤回鞘管从而展开瓣膜时,允许瓣膜膨胀但通过支柱和对应凹处所形成的以用于瓣膜的受控输送的连接来保持瓣膜抵抗从鞘管远端“跳出”。在该阶段,部分展开的瓣膜仍通过端部件810保持,并可通过向远端相对于瓣膜移动轴806来被撤回到鞘管内。当沿向近端方向撤回鞘管使其超过支柱816时,瓣膜支架的膨胀力导致支柱从凹处812、814径向向外膨胀,由此从端部件810完全释放瓣膜。
图55A-55B示出在900表示的导引器的实施例,该导引器可用来将导管或相似器件导引到身体内,例如用于输送和移植人工心脏瓣膜的输送设备。导引器900包括尺寸被制成插入到身体通道(例如,血管)内的细长管道或轴902。管道902从外壳904延伸。具有中心开孔908的罩帽部分906安装到外壳近端,该中心开孔908用于接收导管(没有在图55A-55B中示出)。在罩帽部分和外壳的对置面之间抓卡住密封件910。可由任何合适弹回材料制作密封件,例如硅树脂或各种其它合适弹性体中的任何弹性体。密封件具有对准罩帽部分的开孔908和管道902的内腔的中心开孔912。密封件910的尺寸被制成容许导管被插入贯通开孔912,且同时啮合导管的外表面,从而在将导管被插入到身体内期间最少化血液损失。设置在外壳内的管道902的近端部分具有外螺纹部分914,该外螺纹部分914啮合外壳904的内表面上的对应内螺纹。螺纹部分914的近端延伸部分916接触密封件910。螺纹部分914牢固地固定到管道902,例如用合适粘合剂。在可替换实施例中,管道和螺纹部分可具有其中螺纹部分在管道上直接形成的整体或单件式构造。
外壳904相对于管道902纵向可移动,如通过双头箭头917表示,从而选择性扩大或缩小密封件910中的开孔912。在图解实施例中的外壳904相对于管道902可旋转,从而影响外壳相对于管道的纵向移动。在外壳从近端位置(图55A)移动到远端位置(图55B)时,密封件910抵抗延伸部分916伸展,将密封开孔812从第一直径D1扩大到第二较大直径D2。如上面提及,导引器900可用来辅助导引瓣膜输送设备(例如,在上面描述的输送设备100)到身体内。使用中,管道902被插入到可用传统方式提前扩大的血管(例如,股动脉)内。外壳904然后向远端移动从而将密封件中的开孔扩大到足够大的直径从而容许压缩的瓣膜(和覆盖瓣膜的任何鞘管)通入到管道902的内腔内。在瓣膜(或输送设备的最大部分)穿过密封件之后,外壳在相反方向上旋转,从而向近端移动外壳,从而允许密封开孔912缩小回它的预扩大尺寸。在该状态中,密封件啮合输送设备的外表面,从而防止或至少最少化沿输送设备外表面的血液损失。
图56A-56B示出根据另一实施例的导引器1000。该实施例与图55A-55B的实施例共有许多相似性。因此,在图56A-56B中的部件与在图55A-55B中具有相同的相应参考标记的对应部件相同,并且不进一步描述。导引器1000不同于导引器900之处在于,导引器1000的管道902包括滑动啮合外壳904内表面的外部1002。因此,外壳可相对于902被简单地向远端推动而不是旋转外壳904,来扩大密封开孔912,如在图56B中示出。从外壳904移除人工压力允许密封件910的弹性导致向近端拉回外壳,以便缩小密封开孔。
图57A和图57B示出在1100表示的可用来促进将输送设备(例如,瓣膜输送系统)插入到身体脉管内的整体导引器鞘管和装载器组件。导引器鞘管特别适合与用来移植瓣膜的输送设备(例如在此描述的输送设备实施例)一起使用。导引器鞘管也可用来导引其它类型的输送设备以便将各种类型的管腔内器件(例如,支架、带支架的移植体,等等)放置到许多脉管或非脉管体腔类型(例如,静脉、动脉、食道、胆道树管、肠、尿道、输卵管、其它内分泌管或外分泌管,等等)内。
传统导引器鞘管通常需要管状装载器被插入通过鞘管外壳中的密封件,从而为安装在球囊导管上的瓣膜提供无阻碍路径。装载器从导引器鞘管的近端延伸,由此增加它的工作长度,并减少能够被插入到身体内的输送设备的可用工作长度。导引器鞘管1100包括容纳在鞘管外壳中的集成装载器管,从而减少鞘管的工作长度并因此增加能够被插入到身体内的输送设备的可用工作长度。此外,包括罩帽和相应密封件的传统导引器鞘管通常从导引器鞘管被移除,并在人工瓣膜被安装到轴远端之前被预装载到输送设备的轴上,并且之后在瓣膜和输送设备被插入到鞘管外壳内时被再次附加到鞘管外壳。该过程以该方式执行以便防止人工瓣膜损坏,如果瓣膜在以卷曲状态被安装在轴上时被推动通过密封件中的开孔,那么该损坏可能会发生。在一些情况下,密封件可变得从罩帽内的预期位置移位,这会导致损坏密封件。在这样情况下,用户可能需要分拆开罩帽和密封组件以便修理或替换密封件。
图解的组件1100包括密封外壳1102和从外壳向远端延伸的管状套管1104。密封外壳1102容纳一个或更多密封瓣膜,例如交叉裂缝(cross-slit)瓣膜1106、盘瓣膜1108和止血瓣膜1110,如在图解实施例中示出。瓣膜理想地由弹性生物相容材料制造,例如聚异戊二烯,不过也可使用相似生物相容材料。瓣膜1106、1108和1110在作为参考包括在此的美国专利No.6379372中进一步被示出。垫片1112可被插入到交叉裂缝瓣膜1106和密封外壳的近端之间。
适于沿密封外壳的长度纵向移动的端部件1114被耦合到密封外壳的近端。在图解实施例中,端部件具有管状体,该管状体被形成为具有啮合密封外壳1102的外表面上外螺纹部分1118的内螺纹1116。因此,端部件1114的旋转导致相对于密封外壳相同向内或相外移动。端部件1114在其具有中心开孔1120的近端处具有罩帽部分1119并且端部件1114还具有被牢固地固定在端部件内部的细长装载器管1122。开孔1120和装载器管1122的尺寸被制成容许被安装在输送设备上的瓣膜(或其它假体)通过。端部件1114也容纳具有与开孔1120对准的中心开孔1126的密封件1124。密封件1124在输送设备被插入到导引器鞘管组件1100内时密封地啮合输送设备的外表面。
如上面提及,端部件1114可相对于密封外壳1102被向内和向外调整。将端部件1114从在图57A中的延伸位置调整到在图57B中示出的撤回位置会移动装载器管1122通过密封件1106、1108、1110,从而为瓣膜提供穿过导引器鞘管的无阻路径。因为装载器管不在端部件后面延伸(如在传统导引器管中),所以装载器管不会减少可被插入到脉管系统内的输送设备的可用工作长度。另外,罩帽部分1119可被滑动地安装成在端部件1114上纵向移动,并具有内管状部分1128,该内管状部分1128被定位成啮合并伸展密封件1124。在罩帽部分1119相对于端部件被向远端推动时,管状部分1128伸展密封件1124并将密封开孔1126从第一直径(图57A)扩大到第二较大直径(图57B),从而为进入组件的输送设备和卷曲瓣膜提供无阻碍路径。与传统导引器鞘管相反,罩帽及其相应密封件不需要从鞘管被移除并在将瓣膜安装到输送设备上之前被预装载到输送设备上。如可认识到,图解实施例的配置在装载期间促进将输送设备导引到鞘管内并避免了密封件的可能移位。
使用中,在图57A中示出的延伸位置中的导引器鞘管1110可被放置在先前被插入的引导线(未示出)上,并在其上前进直到套管1104延伸到身体脉管内一期望距离。然后罩帽部分可以被向远端推动,从而扩大密封件1124,从而容许输送设备经过密封开孔1126将瓣膜安置在装载管1122中。由此可允许罩帽部分在密封件的弹性下移动回到近端位置(图57A),由此允许密封件1124形成围绕输送设备外轴的流体紧封密封。随后,端部件1114旋转从而使得装载器管1122滑动通过瓣膜1106、1108、1110(图57B),因此将输送设备放置成与套管1104和其中插入套管的身体脉管的内腔连通。有利地,该方法简化了装载过程,并减少将瓣膜装置到鞘管内所需的步骤和零件的数量。
在导引器鞘管1100的可替换实施例中,密封外壳1102可具有啮合端部件1114上外螺纹的内螺纹。端部件可旋转从而如先前描述地调整装载器管1122的位置。另外,密封外壳和端部件上的螺纹的螺距可改变从而改变延伸装载器使其通过密封瓣膜所需的旋转移动的量。在另一实施例中,可通过推动和拉动端部件而不旋转端部件从而沿密封外壳的长度滑动地定位端部件1114。在另一可替换实施例中,罩帽部分可相对于端部件1114可旋转,从而影响罩帽部分的纵向移动以便扩大密封件,例如在图56A和图56B的实施例中示出。
已知导引器套管通常采用由具有大约0.010到0.015英寸径向壁厚的聚合管材制作的套管。图58A示出在1200表示的采用具有与已知器件相比小得多的壁厚的薄金属管状层的导引器鞘管的另一实施例。在特别实施例中,鞘管1200的壁厚为大约0.0005到大约0.002英寸。导引器鞘管1200包括近端设置的外壳或套节(hub)1202和远端延伸的套管或插管1204。外壳1202可容纳上面详细描述的密封件或一系列密封件,从而最少化血液损失。套管1204包括由金属或金属合金(例如Nitinol或不锈钢)形成的管状层1206,并理想地被形成为具有一系列圆周延伸或螺旋延伸的裂缝或开孔,从而给予套管所需的柔度。
如在图58B中示出,例如,管状层1206被形成(例如,激光切割)为具有交替圆形条带1207和开孔1208的“工字梁”样式,其中轴向延伸连接部分1210连接相邻条带1207。两个相邻条带1207可通过多个成角度隔开的连接部分1210连接,例如通过围绕套管的轴线彼此隔开90度的四个连接部分1210连接,如在图解实施例中示出。套管1204展现充分柔性,从而允许套管被推过曲折路径时柔曲/弯曲(flex)而不扭结(kinking)或屈曲/弯折(buckling)。图59示出可在管状层1206中激光切割或其他方式形成的另一开孔样式。图59的实施例中管状层具有交替条带1212和开孔1214的样式,其中连接部分1216连接相邻条带1212并设置成沿套管长度的螺旋样式。在可替换实施例中,条带和开孔的样式和/或条带和/或开孔的宽度可沿套管的长度改变,以便改变沿套管长度的套管刚性。例如,条带的宽度可从套管的近端向远端减小,从而接近套管的近端提供更大刚性并接近套管的远端提供更大柔性。
如在图60中示出,套管可具有在管状层1206之上延伸并由低摩擦材料制作的薄外层1218,从而减少在套管和套管插入其中的脉管壁之间的摩擦。套管也可具有覆盖管状层1206的内表面并由低摩擦材料制作的薄内层1220,从而减少在套管和插入套管内的输送设备之间的摩擦。内和外层可由合适聚合物制作,例如PET、PTFE和/或FEP。
在特别实施例中,管状层1206具有在大约0.0005英寸到大约0.002英寸范围内的径向壁厚。这样,套管可具有小于已知器件大约1-2Fr的外直径。套管1204的相对小轮廓为具有高钙化动脉、曲折路径或小脉管直径的病人提供了易用性,减少病人经撕裂动脉壁受伤的风险,并增加微创治疗(例如,心脏瓣膜替换)的潜在使用。
在可替换实施例中,代替使用人工动力来旋转转矩轴的旋钮或相似机构或者除了使用人工动力来旋转转矩轴的旋钮或相似机构之外,输送设备可以具有动力源来影响转矩轴的旋转。例如,把手部分308(图35)可容纳被连接到齿轮348并向齿轮348传递旋转运动的小型电动机。这样,用户可通过简单致动把手部分的电动机来影响转矩轴312的旋转(从而使瓣膜10出鞘)。该电动机理想为双向电动机,以便转矩轴可在两个方向上旋转。可替换地,动力源可以是被构造成旋转转矩轴的液压动力源(例如液压泵)或者气动(空气操作的)动力源。
在另一实施例中,动力源(例如,电气、液压或气动动力源)可以可操作连接到又被连接到瓣膜10的轴。动力源被配置成以准确且受控的方式使得轴相对于瓣膜鞘管沿向远端方向纵向往复运动,以便使得瓣膜从鞘管前进出。可替换地,动力源可以可操作连接到鞘管,以便使得鞘管相对于瓣膜沿向近端方向纵向往复运动,从而从鞘管展开瓣膜。
由于本公开发明的原理可应用的许多可能实施例,认识到图解实施例仅是本发明的优选例子并且不视为限制本发明的范围。相反,本发明的范围通过附属权利要求定义。我们因此要求我们的发明全部落入这些权利要求的范围和精神内。
Claims (31)
1.一种经病人脉管系统输送人工心脏瓣膜的心脏瓣膜输送设备,包含:
导管,其包含柔性转矩轴,该转矩轴适合延伸通过所述病人脉管系统,所述转矩轴具有被耦合到所述人工瓣膜的远端部分;以及
瓣膜鞘管,其被配置成在被耦合到所述转矩轴的所述远端部分时接收处于径向压缩状态的所述瓣膜,以便通过所述病人脉管系统输送到所述心脏;
其中所述转矩轴的旋转有效地导致在所述鞘管和所述瓣膜之间的相对纵向移动,从而使得所述瓣膜从所述鞘管前进以便展开在所述心脏中。
2.根据权利要求1所述的设备,其中所述转矩轴的旋转导致所述鞘管相对于所述转矩轴和所述瓣膜纵向移动,从而使得所述瓣膜从所述鞘管前进以便展开在所述心脏中。
3.根据权利要求2所述的设备,其中所述鞘管包含螺纹部分,并且所述转矩轴的所述远端部分包含啮合所述鞘管的所述螺纹部分的螺纹部分,以使所述转矩轴螺纹部分相对于所述鞘管螺纹部分的旋转导致所述鞘管相对于所述转矩轴和所述瓣膜纵向移动,以便使得所述瓣膜从所述鞘管前进以便展开在所述心脏中。
4.根据权利要求3所述的设备,其中所述鞘管的所述螺纹部分包含所述鞘管的内螺纹部分,并且所述转矩轴远端部分的所述螺纹部分包含外螺纹部分。
5.根据权利要求4所述的设备,其中所述外螺纹部分包含外螺纹柱形轴。
6.根据权利要求4所述的设备,其中所述外螺纹部分包含一部分螺线式轴。
7.根据权利要求4所述的设备,其中所述转矩轴的所述螺纹部分包含布置在柔性轴部分上的多个轴向隔开的螺钉,所述螺钉被配置成啮合所述鞘管的所述螺纹部分。
8.根据权利要求2所述的设备,其中所述导管包含连接到所述转矩轴的近端的把手部分,所述把手部分包含可旋转旋钮,该可旋转旋钮被耦合到所述轴并被配置成在所述旋钮旋转时使得所述轴相对于所述鞘管旋转。
9.根据权利要求8所述的设备,其中所述把手部分包含被布置在所述轴上的第一齿轮以及啮合所述第一齿轮并耦合到所述旋钮从而将所述旋钮的旋转运动传递到所述第一齿轮并因此传递到所述轴的第二齿轮。
10.根据权利要求1所述的设备,进一步包含将所述导管耦合到所述瓣膜的瓣膜保持机构,所述瓣膜保持机构被配置成在所述瓣膜和所述导管之间形成可释放连接,在所述瓣膜从所述鞘管前进出之后该连接能够被释放。
11.根据权利要求10所述的设备,其中:
所述瓣膜包含具有多个成角度隔开的支柱的支架,每个所述支柱均具有在其末端部分内的相应开孔;
所述保持机构包含第一叉和第二叉,所述第一叉具有每个都具有接收所述支架的相应支柱的末端部分的开孔的多个尖头,所述第二叉具有每个都延伸通过所述支架的相应支柱中的开孔的多个尖头,由此将所述支架连接到所述保持机构,所述第二叉相对于所述第一叉纵向可移动,从而从所述支架支柱中的所述开孔移除所述第二叉的所述尖头,从而释放在所述瓣膜和所述保持机构之间的连接。
12.根据权利要求11所述的设备,其中所述第二叉被定位成相对于所述第一叉共轴线。
13.根据权利要求12所述的设备,其中:
所述导管包含第一导管;
所述设备进一步包含第二导管,所述第二导管包含延伸通过所述第一导管的所述转矩轴的细长轴,所述轴相对彼此纵向可移动;
所述第一叉耦合到所述第一导管的所述远端部分,并且所述第二叉耦合到所述第二导管的所述远端部分,以使所述第二导管的所述轴沿向近端方向的纵向移动沿相同方向有效移动所述第二叉,从而从所述支架支柱中的所述开孔移除其尖头,从而释放在所述瓣膜和所述保持机构之间的连接。
14.根据权利要求1所述的设备,进一步包含瓣膜收回器件,其适于在至少所述导管的所述远端部分处于所述病人脉管系统中的时候在所述导管之上前进,所述瓣膜收回器件包含径向可膨胀远端部分,该径向可膨胀远端部分适于在膨胀时在所述瓣膜之上延伸,并导致膨胀的瓣膜被压缩以便将所述瓣膜收回到所述鞘管内。
15.一种经病人脉管系统输送人工带支架心脏瓣膜的心脏瓣膜输送设备,包含:
具有远端部分的至少一个细长导管;以及
将所述瓣膜耦合到所述导管的所述远端部分的瓣膜保持机构;
其中所述保持机构包含第一叉和第二叉,每个叉都具有多个成角度隔开的尖头,所述第一叉的每个尖头与所述第二叉的相应尖头配合,从而与所述瓣膜的所述支架形成可释放连接,所述第二叉相对于所述第一叉可移动从而释放所述尖头和所述支架形成的每个连接。
16.根据权利要求15所述的设备,其中:
所述支架具有每个都在其末端部分中具有相应开孔的多个成角度隔开的支柱;
所述第一叉的每个尖头都具有接收所述支架的相应支柱的末端部分的开孔,所述第二支架具有每个都被成尺寸为延伸通过所述支架的相应支柱中的开孔的多个尖头,由此在所述支架和所述保持机构之间形成可释放连接,所述第二叉相对于所述第一叉纵向可移动,从而从所述支架支柱中的所述开孔移除所述第二叉的所述尖头,从而释放所述尖头和所述支架形成的每个连接。
17.根据权利要求15所述的设备,其中所述第一叉和第二叉的所述尖头被配置成将所述导管的纵向和旋转移动传递到所述瓣膜,从而在所述尖头被连接到所述瓣膜时分别影响所述瓣膜的相应纵向和旋转移动。
18.根据权利要求15所述的设备,其中所述瓣膜包含径向可压缩和可膨胀瓣膜,并且所述保持机构被配置成在所述瓣膜在病人体内从压缩状态膨胀到膨胀状态时保持与所述瓣膜的所述支架的每个可释放连接,直到所述第二叉相对于所述第一叉移动,从而释放所述尖头和所述支架形成的每个连接。
19.根据权利要求15所述的设备,其中所述导管包含第一和第二导管,所述第一和第二导管中的每个都包含适合相对于彼此可移动的细长轴,所述第一叉连接到所述第一导管并且所述第二叉连接到所述第二导管,其中相对于所述第一轴移动所述第二轴有效地相对于所述第一叉移动所述第二叉,从而释放所述尖头和所述支架形成的每个连接。
20.一种在具有环的移植部位处移植的人工心脏瓣膜,所述瓣膜包含:
径向可膨胀和可压缩的支持框架,所述支持框架包含多个立柱构件,所述立柱构件彼此互联从而形成包含流入端和流出端的网孔结构,所述网孔结构包含在第一位置具有第一直径的扩张的中间部分,所述中间部分在朝向所述流入端的方向上渐细,从而在第二位置形成具有第二较小直径的流入端部分;以及
具有相应流入端部分和流出端部分的多个瓣叶,所述瓣叶的所述流入端部分在所述网孔结构的所述流入端部分处被固定到所述网孔结构的内侧,并且所述瓣叶的所述流出端部分限定在所述网孔结构的所述流出端处被固定到所述网孔结构的所述内侧的成角度隔开的连合。
21.根据权利要求20所述的心脏瓣膜,其中所述网孔结构的所述流入端部分具有张开部分,该张开部分从所述第二位置向在具有第三直径的所述网孔结构的所述流入端处的第三位置直径上增加,所述第一和第三直径大于所述第二直径。
22.根据权利要求21所述的心脏瓣膜,其中所述中间部分在朝向所述流出端的方向上渐细,从而形成具有小于所述第一直径的第四直径的流出端部分。
23.一种输送人工心脏瓣膜的输送设备,包含:
第一细长轴,其具有近端和适合连接到所述瓣膜的远端;
第二细长轴,其在所述第一轴之上延伸并具有近端部分和包括鞘管的远端部分,该鞘管被配置成当所述瓣膜处于径向压缩状态时在所述瓣膜之上延伸;以及
耦合到所述第一轴和第二轴的所述近端的把手,所述把手包含可旋转致动器和可操作连接到所述致动器并连接到所述第二轴的所述近端的螺钉,所述致动器被配置成啮合所述螺钉的外螺纹,其中所述致动器的旋转导致所述螺钉和第二轴相对于所述第一轴的纵向移动,从而相对于所述瓣膜撤回所述鞘管;
其中所述致动器包含在啮合位置和脱离位置之间可运动的闩锁,其中在所述啮合位置所述闩锁啮合所述螺钉的所述螺纹,在所述脱离位置所述闩锁脱离所述螺钉的所述螺纹,从而在所述闩锁处于所述啮合位置时所述致动器的旋转导致所述螺钉的纵向移动,并在所述闩锁处于所述脱离位置时,所述螺钉可相对于所述第一轴纵向移动且所述致动器不旋转。
24.根据权利要求23所述的设备,其中所述闩锁限定所述螺钉可延伸通过的开孔,所述开孔具有由可啮合所述螺钉的所述螺纹的对置表面所限定的第一段和由不可啮合所述螺钉的所述螺纹的对置表面所限定的第二段,其中在所述闩锁移动到所述啮合位置时,所述开孔的所述第一段的表面被置于围绕所述螺钉,并且在所述闩锁移动到所述脱离位置时所述第二段的表面被置于围绕所述螺钉。
25.一种输送具有支架的人工心脏瓣膜的输送设备,包含:
具有远端部分的至少一个细长导管;
适合在所述瓣膜和所述导管的所述远端部分之间形成可释放连接的可释放瓣膜保持机构,所述瓣膜保持机构包含从所述导管的所述远端部分延伸的多个缝线,每个缝线都延伸通过并啮合所述支架的一部分并在一个末端具有环圈,所述瓣膜保持机构进一步包含延伸通过每个缝线的所述环圈以便将所述瓣膜连接到所述导管的细长可滑动构件,所述可滑动构件相对于所述缝线可撤回,从而从所述可滑动构件释放所述环圈,并由此释放在所述瓣膜和所述导管之间的连接。
26.根据权利要求25所述的输送设备,其中所述缝线具有连接到朝向所述瓣膜向远端可滑动的另一可滑动构件的近端,从而允许所述支架的所述部分啮合所述缝线,从而在所述支架保持经所述缝线连接到所述导管时膨胀。
27.一种输送人工心脏瓣膜的输送设备,包含:
细长导管,其具有适合耦合到所述人工瓣膜的远端部分;
瓣膜鞘管,其被配置成当被耦合到所述导管的所述远端部分时在处于径向压缩状态的所述瓣膜之上延伸,所述鞘管包含由在所述瓣膜之上延伸的第一管状折叠层和在所述第一管状折叠层之上延伸的第二管状折叠层形成的折叠部分,所述第二折叠层相对于所述导管和所述瓣膜纵向可移动,从而使得所述瓣膜出鞘。
28.一种组件,包含:
包含自膨胀支架的人工瓣膜,所述支架具有多个成角度隔开的支柱;以及
将所述瓣膜输送到病人体内的移植部位处的输送设备,所述输送设备包含具有远端部分的细长轴,所述远端部分具有在其外表面中形成并被成尺寸为接收所述支架的相应支柱的多个凹处,所述输送设备也包含外鞘管,该鞘管的尺寸被制成在所述瓣膜之上延伸并用被置于相应凹处中的所述支柱而将所述瓣膜保持在压缩状态,所述鞘管和所述轴相对于彼此纵向可移动从而使所述瓣膜出鞘,由此允许所述瓣膜膨胀。
29.一种包含具有内腔并适合被插入到病人脉管系统内的细长管状套管的导引器鞘管,所述套管包含金属层,所述金属层包含沿所述金属层的长度隔开的多个条带以及被插入到相邻条带之间的圆周延伸开孔。
30.根据权利要求29所述的导引器,进一步包含密封外壳,所述密封外壳被耦合到所述套管的近端。
31.一种导引器鞘管,包含:
具有内孔洞的外壳、在所述外壳上纵向可移动的罩帽部分、安装到所述罩帽部分并具有与所述内孔洞对准的开孔的弹性体密封件,其中所述罩帽部分在所述外壳上从第一位置可移动到第二位置,从而沿径向方向伸展所述密封件以便扩大在所述密封件中的所述开孔;以及
从所述外壳的所述内孔洞延伸的细长管状套管,所述套管具有内腔并适合被插入到病人脉管系统中。
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PCT/US2009/054290 WO2010022138A2 (en) | 2008-08-22 | 2009-08-19 | Prosthetic heart valve and delivery apparatus |
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