CN102245256B - 医疗装置以及用于输送医疗装置的输送系统 - Google Patents
医疗装置以及用于输送医疗装置的输送系统 Download PDFInfo
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- CN102245256B CN102245256B CN200980150320.2A CN200980150320A CN102245256B CN 102245256 B CN102245256 B CN 102245256B CN 200980150320 A CN200980150320 A CN 200980150320A CN 102245256 B CN102245256 B CN 102245256B
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Abstract
医疗装置以及用于将医疗装置输送到对象体内的目标位置的输送系统。在一些实施例中,可以将所述医疗装置锁在完全展开且锁定的构造下。在一些实施例中,给所述输送系统配备单个的致动器以控制所述输送系统的多个部件的运动。在一些实施例中,所述致动器控制所述输送系统多个部件的独立运动以及从属运动。
Description
相关申请的交叉参考
根据美国专利法第119条,本申请要求2008年10月10日提交的美国临时专利申请No.61/104,509和2009年2月11日提交的美国临时专利申请No.61/151,814的优先权,这些申请通过引用全部包含于此。
本申请涉及下列专利申请,这些专利申请通过引用全部包含于此:2003年12月23日提交的美国专利申请No 10/746,240(美国专利公开号No.2005/1237687);2004年10月21日提交的美国专利申请No.10/972,287(美国专利公开号No.2005/0137698);2004年11月5日提交的美国专利申请No.10/982,692(美国专利公开号No.2005/0137699);2007年2月14日提交的美国专利申请No.11/706,549(美国专利公开号No.2007/0203503);2008年10月10日提交的美国临时专利申请No.61/104,509;2005年11月14日提交的美国专利申请No.11/274,889(美国专利公开号No.2007/0112355);2004年6月16日提交的美国专利申请No.10/870,340(美国专利公开号No.2005/0283231);以及2005年12月20日提交的美国专利申请No.11/314,969(美国专利公开号No.2007/0118214)。
背景技术
可植入的医疗装置可以被输送到对象体内的目标位置,植于其中。例如,熟知的有管腔内输送技术。它的输送系统主要包括鞘(sheath)和/或导管,通过所述鞘和/或导管将植入体输送到目标位置。通常从所述鞘或者导管中将所述植入体展开在目标位置处。一些可植入的装置完全是自扩张式的;当将它们从所述鞘中或者导管中释放出来时,它们自扩张,在该自扩张步骤之后不需要再进一步扩张。通过在近侧缩回(retract)所述鞘或者导管、通过将所述可植入装置从所述鞘或者导管推出、或者通过这两种方式的组合,会出现所述自扩张。但是,一些可植入装置被配置成适于在所述自扩张步骤的过程中或者在所述步骤之后致动。在于2004年11月5日提交的共同未决专利申请No.10/982,388和于2003年12月23日提交的专利申请No.10/746,120中描述了可以在自扩张步骤之后被致动的示例置换心脏瓣膜,这些公开内容通过引用包含于此。将可扩张的医疗装置锁在完全展开并锁定的构造下以将所述装置固定在展开状态是有利的。
在所述输送过程中,所述输送系统可以通过使用一个或多个致动器来致动所述医疗装置。例如,可以致动(例如,转动)一个致动器(例如,形式是所述输送系统的手柄上的一个旋钮(knob),使所述输送系统的一个部件相对于所述输送系统中的另一个部件移动,或者相对于所述可植入装置移动,或者相对于二者而移动。通常需要使所述输送过程对医生而言尽可能容易,以缩短完成手术所需的时间,并降低所述输送系统机械结构的复杂性。在一些输送手术中,需要致动所述输送系统的多个部件来展开植入体。也必须确保所述多个步骤是按特定的顺序完成的。所需要的输送系统是可以简化所述医疗装置的展开过程以及/或者确保所述多个步骤是按照特定的顺序来执行的。
发明内容
本说明书的一个方面描述了一种医疗装置系统,包括具有布置在对象体外的壳体的输送系统,其中所述壳体包括致动器,其中配置和设置所述输送系统,使得所述致动器适于以独立于第二输送系统部件地移动第一输送系统部件,以及其中进一步配置和设置所述输送系统,使得所述致动器适于,以独立于所述第一输送系统部件地移动所述第二输送系统部件。
在一些实施例中,进一步配置和设置所述输送系统,使得所述致动器适于,以同时致动所述第一输送系统部件和所述第二输送系统部件,在一些例子中,当同时致动它们时,速率不同。
在一些实施例中,配置所述输送系统,使得所述致动器的致动使所述第一和第二输送系统部件在同一个方向上移动。在一些实施例中,配置所述输送系统,使得所述致动器的致动,按特定的顺序致动所述第一和第二输送系统部件。
在一些实施例中,所述致动器是单个的致动器元件,并且其中配置所述致动器,使得所述致动器在单一类型动作的致动不仅使所述第一输送系统部件的致动独立于所述第二输送系统部件,而且使所述第二输送系统部件的致动独立于所述第一输送系统部件。
在一些实施例中,所述第一输送系统部件是输送鞘,其中所述医疗装置系统包括适于穿过所述输送鞘、经皮输送到患者体内的目标位置的医疗装置,其中所述致动器适于,以独立于所述第二输送系统部件地并在独立移动所述第二输送系统部件之前移动所述输送鞘。所述第二输送系统部件可以被可逆地地联接到所述医疗装置的一部分。所述致动器适于,当致动它时,向近侧独立地移动所述鞘和所述第二输送部件。可以将所述致动器的致动配置成向近侧缩回所述鞘,以让所述医疗装置扩张,并且其中所述致动器的进一步致动向近侧缩回所述第二输送系统部件。
在一些实施例中,配置所述输送系统和致动器,使得在单一类型动作下的所述致动器的运动,诸如单方向上的转动,令所述第一输送系统部件独立于第二输送系统部件地移动,并且令所述第二输送系统部件独立于所述第一输送系统部件地移动。所述单类型的动作可以独立于第二输送系统部件地移动所述第一输送系统部件,并独立于所述第一输送系统部件地移动所述第二输送系统部件,而不用在独立移动所述第一输送系统部件和独立移动所述第二输送系统部件之间有任何介于中间的致动步骤。
本发明的一个方面是一种使用输送系统在对象体内展开医疗装置的方法。该方法包括提供包含放置在对象体外的壳体的输送系统,其中所述壳体包括致动器,致动所述致动器,以独立于第二输送系统部件地移动第一输送系统部件,并且致动所述致动器,以独立于所述第一输送系统部件地移动所述第二输送系统部件。
在一些实施例中,所述方法进一步包括致动所述致动器,以同时移动所述第一和第二输送系统部件。在一些实施例中,致动所述致动器包括在单一类型动作的方式致动所述致动器,使所述第一和第二输送系统部件的移动彼此独立,以及同时移动所述第一和第二输送系统部件。致动所述致动器可以至少在同时移动所述第一和第二输送系统部件的一部分时间内,以不同的速度移动所述第一和第二输送系统部件。
在一些实施例中,致动所述致动器,在同一个方向上移动所述第一和第二输送系统部件。在一些实施例中,致动所述致动器,按特定的顺序移动所述第一和第二输送系统部件。
在一些实施例中,致动所述致动器包括以诸如单方向转动之类的单一类型动作致动所述致动器,以使所述第一和第二输送系统部件彼此独立地移动。
在一些实施例中,所述第一输送系统部件是输送鞘,并且其中致动所述致动器包括,独立于所述第二输送系统部件、并在独立移动所述第二输送系统部件之前,在近侧方向上移动所述输送鞘。所述第二输送系统部件可逆地联接到医疗植入体,并且其中致动所述第二输送系统部件,使所述第二输送系统在近侧方向上独立于所述输送鞘、并在所述输送鞘的近侧移动之后移动。
在一些实施例中,移动所述第一和第二输送系统部件包括向近侧移动所述第一和第二输送系统部件。
在一些实施例中,致动所述致动器以移动所述第一输送系统部件包括向近侧移动输送鞘,以让所述医疗装置扩张。
本发明的一个方面是一种用于在对象体内展开医疗装置的输送系统。该系统包括输送鞘;适于以布置在所述鞘内并可以相对于所述鞘移动的输送导管;适于可逆地联接到医疗装置的一部分的联接构件,其中所述医疗装置适于,通过所述输送鞘将它经皮输送到患者体内的目标位置,其中所述输送鞘适于,使它相对于所述医疗装置地移动,以从所述鞘释放出所述医疗装置;以及套鞘辅助元件,当将所述输送鞘套住至少所述医疗装置的近侧部分时,所述套鞘辅助元件至少有一部分布置在所述鞘的远侧和所述医疗装置的近侧部分之间。
在一些实施例中,所述套鞘辅助元件的近侧部分附接在所述输送导管的远侧区域。在一些实施例中,所述联接构件的近侧端附接在所述输送导管的远侧区域。
在一些实施例中,所述套鞘辅助元件的近侧端附接在所述输送导管的远侧区域,并且其中所述联接构件的近侧端附接在所述输送导管的远侧区域,并且其中所述套鞘辅助元件相对于所述联接构件在径向上向外。
在一些实施例中,所述套鞘辅助元件包括多个圈状元件,其中所述圈状元件中的第一个的长度与所述圈状元件中的第二个的长度不同。
在一些实施例中,所述医疗装置包括编织的元件,并且其中所述套鞘辅助元件包括多个套鞘辅助元件,其中,当所述鞘正套住所述编织的元件时,所述多个套鞘辅助元件中的第一个元件在径向上设置在所述编织的元件的近侧端的外部,并且其中所述多个套鞘辅助元件中的第二个元件延伸穿过所述编织的元件。
本发明的一个方面是一种将医疗装置套在输送鞘内的方法。该方法包括将套鞘辅助元件定位在可扩张的医疗装置的一部分和输送鞘之间,相对于所述套鞘辅助元件和所述医疗装置向远侧移动所述输送鞘,以辅助将所述可扩张的医疗装置的至少一部分折叠在所述输送鞘内。
在一些实施例中,所述定位步骤包括将所述套鞘辅助元件定位在至少所述可扩张的医疗装置的近侧端和所述输送鞘的远侧端之间,以降低随着所述输送鞘相对于所述套鞘辅助元件向远侧移动,所述鞘的远侧端钩在所述医疗装置的近侧端上的可能性。
在一些实施例中,所述输送系统进一步包括联接构件,所述方法进一步包括保持所述联接构件和所述医疗装置之间的可逆联接(reversible couple),其中定位所述套鞘辅助元件包括将所述套鞘辅助元件相对于所述联接构件在径向上朝外地定位。
在一些实施例中,相对于所述套鞘辅助元件向远侧移动所述输送鞘,导致在径向上向里的力从所述套鞘辅助元件施加到所述可扩张的医疗装置的那部分上。
通过引用的包含
在本说明书中提到的所有出版物和专利申请通过引用包含于此,就像具体且个别地指出每个个别的出版物或者专利申请通过引用包含于此一样。
附图说明
在权利要求中详细地罗列了本发明的新特征。通过参考下文对所罗列的利用了本发明原理的说明性实施例的详细描述及附图,将会更好地理解本发明的特征和优点:
图1A所示为在展开并锁定的结构下的示例的置换心脏瓣膜。
图1B所示为在折叠和输送状态下的示例的置换心脏瓣膜。
图2A图示的是可逆地联接到医疗装置的示例的医疗装置输送系统,其中所述医疗装置是在折叠结构下。
图2B图示的是可逆地联接到医疗装置的示例的医疗装置输送系统,其中所述医疗装置是在展开并锁定的结构下。
图3A-3G图示的是示例的医疗装置展开和锁定手术。
图4所示为可逆地联接到输送系统的一部分的示例的置换心脏瓣膜。
图5A-5E所示为示例的用于医疗装置的锁定和释放机构。
图6A和6B所示为在输送系统和医疗装置之间的示例的可逆联接机构。
图7A-7D所示为示例的医疗装置的锁定和释放机构。
图8A-8D所示为示例的医疗装置的锁定和释放机构。
图9所示为在输送系统和医疗装置之间的示例的可逆联接机构。
图10所示为在输送系统和医疗装置之间的示例的可逆联接机构。
图11A-11D所示为示例的医疗装置的锁定和释放机构。
图12A-12D所示为示例的医疗装置的锁定和释放机构。
图13-14E所示为示例的医疗装置的锁定和释放机构。
图15A-16B所示为示例的医疗装置的锁定和释放机构。
图17A-17D所示为示例的输送系统的一部分,其中单个的手柄致动元件可以使两个不同的输送系统部件独立于彼此地移动。
图18A-18D图示的是改变致动元件的行进速度的变化的螺距设计。
图19图示的是控制输送系统部件的移动速度的示例的筒形凸轮(barrel-cam)设计。
图20A-20C图示的是示例的输送系统的一部分,其中单个的手柄致动元件可以使两个不同的输送系统部件独立于彼此地移动。
图21-22图示的是用于解联接所述杆和外部鞘的动作的示例设计。
图23A-23C图示的是致动第二致动器以控制所述医疗装置输送过程的不同部分的运动。
图24-41图示多种医疗装置套鞘辅助元件。
具体实施方式
本说明书描述了医疗装置和用于将医疗装置输送到对象体内目标位置处的输送系统。所述医疗装置可以是可植入的,或者适于将它们暂时定位于对象体内。所述输送系统适于将多种类型的适当的医疗装置输送到对象体内的目标位置,但是,在一些实施例中可以配置它们用于微创侵入式输送手术,诸如血管内手术。在一些实施例中,所述医疗装置是一个置换心脏瓣膜(例如,置换主动脉心脏瓣膜),配置所述输送系统,以在血管内输送所述置换心脏瓣膜来替代对象的天然心脏瓣膜的功能。
图1A和1B所示为包括锚定元件12和置换瓣叶14(为了清楚起见,图1B中未示)的置换心脏瓣膜10,所示的锚定元件由编织材料构成。置换心脏瓣膜10还包括三个第一锁定构件16,也称作桩,以及三个第二锁定构件18,也称作锁扣。所示为三个桩和三个锁扣,每个桩与其中一个锁扣相关联。图1A显示了在充分展开构造下的锚定元件12,这里也称作锚,其中通过第一锁定构件16和第二锁定构件18之间的锁定相互作用将锚定元件12锁在并保持在展开的构造下。图1B显示的是在折叠的输送构造下的置换心脏瓣膜10,其中在输送系统内将所述置换心脏瓣膜输送到对象体内的目标位置(输送系统未示)。
在这个实施例中,瓣叶14在所述瓣膜的三个交界处附接在桩16上。因而桩16将所述瓣膜支撑在所述锚定元件内。所述桩和所述锁扣(或者其它适当的第一和第二锁定构件)都联接在所述锚上。当锚定元件12是在如图1B所示的折叠构造下时,所述桩16上的每个锁定元件被配置为与锁扣18上对应的锁定元件锁在一起,并且位于相对于适于与之锁定的所述锁扣的锁定元件的远侧。换句话说,在所述输送构造下,被配置为锁在所述桩的所述锁定元件上的所述锁扣的锁定元件位于所述桩的锁定元件的近侧。
图2A和2B图示的是输送系统100及其部件的示例实施例,所述输送系统100可以用于输送和在对象体内的目标位置展开(deploy)医疗装置。输送系统100包括手柄120、鞘110、与鞘110设置在一起的导管108以及可逆地联接到置换心脏瓣膜10的致动元件106A和106B。在图2A中,在鞘110内,心脏瓣膜10是在折叠的输送构造下(在图1B中也有显示)。输送系统100还包括引导线G和前锥体102。在一些实施例中,导管108具有中心腔管(lumen)109和多个设置在周边的腔管Lu。
在图2A和2B中,所显示的多个致动元件106A可逆地联接到锚定元件12的近侧区域。具体地,致动元件106A经由可逆地联接机构可逆地联接到锚定元件12的近侧。致动元件106B可逆地联接到所述置换心脏瓣膜在所述锚定元件的近侧的远侧的一个区域。具体地,所显示的致动元件106B经由可逆地联接的机构可逆地联接到桩16。这个及类似实施例的细节可以在美国公开专利No.2005/0137686和No.2005/0143809中找到,它们的披露内容通过引用包括于此。
在图1A-2B所示的实施例中,所述锚定元件包括诸如镍钛诺之类的编织材料,由一股或多股材料形成。在一个实施例中,所述锚定元件12是由形状记忆材料形成,并被热定型为自扩张后的构造,使得当将所述锚定元件从所述输送系统的鞘中展开时,所述编织物将自然地开始缩短,并从所述折叠的输送结构扩张到所述记忆自扩张后的结构。所述自扩张后的构造可以被认为是在松弛状态或者局部展开的构造下,在美国公开专利No.2005/0137686和2005/0143809中有更多的细节。一旦所述锚定元件已经扩张为所述局部展开的构造,经由设置在患者体外的手柄上的致动器来致动致动器106A和106B中的至少一个。如在美国公开专利No.2005/0137686和No.2005/0143809中所描述的,可以相对于致动元件106A的近侧方向上致动致动器106B,这样会将指向近侧的力施加给所述桩,这将所述指向近侧的力量施加到所述锚定元件的远侧区域。可替换所述指向近侧的力量或者除此之外,可以在远侧方向致动致动器106A,以将指向远侧的力量施加在所述锚定元件的近侧区域。所述指向轴向的力量有力地缩短所述锚定元件,将所述桩移近所述锁扣,直到所述桩和所述锁扣锁在一起,以将所述锚定元件锁定在充分展开和锁定的构造下。所述锁定的构造因而比其局部展开的构造短。
图3A-3G图示一种输送在输送构造下的置换主动脉心脏瓣膜并将它从输送鞘展开到充分展开并锁定的构造下的示例方法。在这个实施例中,致动元件106B可逆地联接到所述置换瓣膜的桩,但是,致动元件106A,在这里也可以称作是“指部”,可逆地联接到所述锁扣。三个致动元件106A可逆地联接到所述三个锁扣上,三个致动元件106B可逆地联接到所述三个桩。如图3A所示,在鞘110内以后退的方式输送在折叠输送构造下的置换瓣膜10,经由导线G穿过主动脉A,并用已知的经皮技术放置在患者的主动脉瓣膜上。
如图3A所示,一旦将鞘110定位在天然的瓣膜上,使用设置在患者体外的输送系统的手柄上的致动器在近侧相对于所述置换瓣膜缩回鞘110。随着所述鞘的抽回(withdrawal),如图3B所示,由于锚定元件12的材料属性,锚定元件12的远侧部分开始自扩张。所述锚定元件可以具有记忆自扩张的构造,使得随着所述鞘被抽回,所述锚开始自扩张,或者恢复到它的记忆构造。随着继续在近侧缩回所述鞘,所述锚定元件继续自扩张,如图3C和3D所示。在图3E中,已经在近侧缩回(retract)所述鞘,使得所述鞘的远侧端位于指部106A的远侧端的附近。在图3E中,没有在近侧将所述鞘缩回足够远,以允许所述指部自扩张。因此,虽然所述锚定元件完全在所述鞘之外,但是所述锚的近侧端不会朝其记忆构造扩张。只有在已经将所述鞘缩回经过导管108的远侧端时,所述指部才可以充分扩张,如图3F所示。这样允许所述锚定元件的近侧端扩张。
然后,通过应用指向轴向的(指向近侧和远侧的)力量,将所述锚定元件有力地缩短(以及潜在地进一步扩张)到充分展开和锁定的构造下,如图3G所示。要有力地缩短所述锚定元件,指向近侧的力量经由致动元件106B(虽然图3A-3G中未示,但它们联接在所述桩上)施加在所述桩上,并且/或者指向远侧的力量经由致动元件106A施加在锁扣上。在一个实施例中,通过致动元件106B将指向近侧的力量施加在所述桩上,使指部106A保持在适当的位置,以将指向远侧的力量施加到所述锁扣上。在图3G中,这样有效地缩短所述锚定元件使得所述桩和锁扣在轴向上更靠近彼此,直到它们锁在一起,这样使所述锚定元件保持在完全展开和锁定的构造下。然后,分别从所述锁扣和桩松开致动元件106A和106B的联接,然后从对象身上去掉所述输送系统。在下文中进一步详细描述示例的锁定过程和松开过程的细节。包含在这个和其它实施例中的输送、展开、锁定和释放过程的额外的细节可以在2004年11月5日提交的美国公开专利No.2005/0137699、2007年2月14日提交的美国公开专利No.2007/0203503和2004年10月21日提交的美国公开专利No.2005/0137697中有描述,这些公开专利中的每一个都通过引用包含于此。
图4显示的是替换心脏瓣膜10和其包括导管208的输送系统的远侧部分,参考图3A-3G对它们进行描述。心脏瓣膜10是在充分展开和锁定的构造下,致动元件206A(“指部”)和206B仍然分别可逆地联接到锁扣18和桩16上。因此,图4的构造和布局类似于图3G中所示的构造和布局。瓣叶14的交界部分附接在三个桩16上,而桩16在远离锚定元件12近侧的一个位置可移动地联接到(例如,经由缝线(suture)或者线)锚定元件12上。置换心脏瓣膜10还包括锁扣18(显示了三个),它们在锚12的近侧区域附接在(但是与所述桩类似,可以移动地联接到所述锚)锚12上(例如,经由线或者缝线)。在图4中,致动元件206B可逆地联接在桩16上,而致动元件206A可逆地联接到锁扣18上。所述输送系统还包括三个致动器保持元件210,每一个致动器保持元件适于在其中容放致动元件206B和致动元件206A。所显示的致动元件206A在它们的近侧附接在导管208的远侧,而配置和设置致动元件206B在导管208内沿轴向移动。因此,配置和设置致动元件206B,使它们也相对于致动元件206A在轴向上运动。用致动器保持元件210,使指部206A和致动元件206B保持彼此之间接近地间隔开(至少当所述输送系统联接在所述置换瓣膜时)。保持元件210其中有管腔,在该管腔中放置指部206A,穿过所述管腔可以在轴向上致动致动元件206B。所示的指部206A相对于致动元件206B在径向上朝外设置,显示大体为圆柱形的杆。图4中的置换心脏瓣膜还没有从所述输送系统释放。
图5A-5E图示的是从图4中所示的心脏瓣膜解除所述输送系统的联接(锚定元件未示)的过程。在图5A中,桩16具有一个狭长形的锁部17,其适于被拉入锁扣18内的内部通道之中。桩16的锁部17具有凹槽状的锁定元件,其适于容放锁扣18上的齿。随着将所述桩拉入所述锁扣中,所述锁扣上的齿将卡合所述桩上的凹槽,将所述桩和锁扣锁在一起,使所述锚定元件保持在锁定构造下。这个构造显示在图5A中。在这个构造中,致动元件206B(或“杆”)可逆地联接到桩16。杆206B有一部分设置在桩16中的通道内,使得杆206B远侧部分中的孔230(见图5E)与桩16的孔232对准。作为销组件236的一部分,销234,如从图4中可见,延伸穿过杆孔230和柱孔232二者,将所述杆联接到所述桩。所述销的远侧部分呈现为卷曲状或者环状构造,这样防止杆206B脱离桩16。在图5A中,经由锁扣18上的齿239和指部206A上的凹槽238之间的相互作用(见图5E),将指部206A可逆地联接到锁扣18。在图5A中,在齿239和凹槽238之间的卡合结构之上设置卡箍22,以使指部206A和锁扣18保持在可逆地联接的构造下。
一旦已经确定要将所述心脏瓣膜释放在对象体内的适当位置,首先通过在近侧方向上缩回销组件236(见图4)来去掉销234,这样拉着销穿过孔230和232,使杆206B和桩16分离,这在图5B中显示。接下来,通过致动在所述输送系统的手柄上的致动器,在近侧方向上拉回杆206B。一旦已经将杆206B拉到图5C中的位置,卡箍卡合装置23卡合于卡箍22,并沿着杆206B在近侧方向上拉它。这样造成在近侧将所述卡箍从图5C中的位置拉到图5D中的位置。不断使杆206B缩回,令所述卡箍缩回到图5D中的位置,让所述锁扣的齿239脱离凹槽238,这在图5E显示。杆206B和指部206A都脱离所述心脏瓣膜,现在将所述输送系统从患者那里缩回,而所述医疗装置植入在合适的位置。
在一些实施例中,通过指部206A施加到所述锁扣上的指向轴向的力矢量及通过所述杆206B施加到所述桩上的指向轴向的力矢量,可以是基本上方向相反的,以提高所述缩短和锁住过程的效率。将所述指部直接联接到所述锁扣的优点是,在所述缩短和锁定过程中,所述锁扣更好地和所述桩对准。这样可以有助于确保当在近侧拉所述桩时,会使所述桩更好地与所述锁扣对准,使得可以有效地将所述桩与所述锁扣锁在一起。当使用可能会在大的缩短力量和锁定力量下发生缠绕或者扭曲的锚时(诸如包括编织材料的锚),有益于确保联接在所述锚上的(以及因而可能与所述桩脱离对准的)锁扣仍然保持正常地与所述桩对齐。将所述指部直接联接到所述锁扣上会具有这些优点。这样还可以增加指向近侧的拉力的整体效率,因为牵拉并锁住所述桩与所述锁扣所需要的力较小。当将致动器结合在手柄上来控制医疗装置的输送和展开时,减小在所述手柄致动器上所需要施加的力能够简化所述输送系统的设计。
图6A和图6B图示的桩250的可替换实施例,它可逆地联接到致动元件252上。图6B是体现图6A中所示的部件的局部分解视图。致动元件252包括杆254、耳片偏转件(tab deflector)256和保持夹258。如前文所描述的,通过致动设置在患者体外的手柄上的致动器,可以在近侧方向P上致动杆254。
杆254附接在耳片偏转件256和保持夹258上。杆254在其远侧包括塞(catch)260,它与保持夹258的夹元件262卡合。桩250其中有内部通道,其适于滑动地容放保持夹258和耳片偏转件256,它们中的每一个都适于在其中容放杆254。耳片偏转件256包括肋片元件264。保持夹258包括夹脚266。要锁住所述锚定元件(图中未示),在近侧方向上牵拉杆254,夹脚266与桩250的远侧端卡合,并在近侧方向上将桩250拉向所述锁扣(图中未示)。
图7A-7D显示的是图6A和图6B所示的桩250的示例的锁定顺序(未示出锚)。图7A显示通过用从患者体外的输送系统的手柄上的致动器上产生的致动力在近侧致动杆254。在图7A中,桩250仍然在锁扣268的远侧。随着继续在近侧方向上拉杆254,塞260(图6B所示)将指向近侧的力量施加到夹元件262上(图6B所示)。这样使夹脚266将指向近侧的力量施加到桩250的远侧。这样使所述桩在近侧方向上移动。桩250、耳片偏转件256和保持夹258因此朝锁扣268移动,如图7A所示。
患者体外的致动器的连续致动使得在近侧方向上进一步将所述桩、所述偏转件和所述夹子拉到锁扣268内的通道内的一个位置,如图7B所示。因为耳片偏转件256的肋片元件264被布置在桩250的凹槽272的附近,肋片元件264防止锁扣齿270与桩250的凹槽272卡合(图7B所示)。这样防止了所述桩与所述锁扣锁在一起,直到医生判断适于锁在一起的时候。因此肋片元件264的作用是锁定防止机构。使用所述手柄上的致动器,通过施加指向远侧的力量在桩250上,可以在远侧移动所述桩(以及因而移动所述锚)以在这一点加长所述锚定元件。
一旦已经达到所述锚的期望位置,继续在近侧方向上致动杆254。使用所述手柄上的同一个致动器或者使用在下文中详细描述的不同的致动器可以做到这一点。给杆254施加的连续的近侧力将脚266向内朝向彼此夹紧,从而使它们脱离与桩250的远侧的卡合和联接。这将脚266拉入桩250的远侧开口内。这样将夹子258从桩250松开,并使所述杆、偏转件和夹子与所述桩脱离联接。连续致动致动器将使所述线缆(cable)、偏转件和夹子在近侧方向上移动到图7C所示的位置。肋片元件264设置在齿270和凹槽272的近侧,因此不再防止它们锁在一起。所述齿因而与所述凹槽卡合在一起,将所述桩锁在所述锁扣上(图7C所示)。现在,所述锚(图中未示)被锁在充分展开和锁定的构造下。连续致动杆254从患者那里拉出所述杆、夹子和偏转件,如图7D所示。
图8A-8G图示桩、锁扣和致动元件的替换实施例的锁定和释放顺序的侧视图。所述系统包括杆形式的致动元件280、锁扣282、桩286和夹子290。夹子290包括夹脚294和肋片元件292。手柄上的致动器致动使得在近侧的“P”方向上牵拉杆280,如图8A所示。连续致动牵拉杆280、桩286和夹子290穿过锁扣282内的通道,如图8B所示。随着继续牵拉杆280,锁扣齿284的表面滑过夹子290的表面295,如图8B所示。夹脚294卡合锁扣282的远端,如图8C所示。这个位置的俯视图在图8G中显示。在图8B和图8C所示的位置之间,肋片元件292防止了所述桩与所述锁扣锁在一起。在图8C所示的位置中,齿284正在卡合桩286的表面287。夹脚294的位置确保在将夹子290从所述桩上移除之前,已经在近侧将所述桩的凹槽288拉得足够远。从图8C所示的位置,杆280连续地在近侧移动将促使夹脚294夹紧在一起,并缩回到锁扣282内的通道内。这样将夹子290从桩286桩松开,并在近侧方向上拉所述杆和夹子。一旦将所述夹子从所述桩上松开,所述桩将开始自行在远侧方向上移动,因为所述锚定元件(图中未示,但是在这个实施例中包括编织的材料)开始自行恢复到自扩张、局部展开的记忆构造下(这在通过引用包括于此的申请中更详细地描述)。随着所述桩开始在远侧移动,齿284卡合桩的凹槽288,如图8E所示。这样锁住所述桩和所述锁扣,并将所述锚定元件锁定在充分展开和锁定的构造下。现在从患者对象那里移去所述杆和夹子,如图6F所示。
图9和10显示包括上文的锁定和释放特征的实施例的两个可替换实施例。图9中的实施例与图5A-5E所示的类似,虽然杆304包括与图6A-8G的实施例中所示的夹脚类似的夹脚306。在这个实施例中,不需要图5A-5E的销234,随着在近侧牵拉杆304时,杆304与桩300松开,将夹脚306朝里夹紧,并与所述桩脱离。
图10显示一个可替换的实施例,它包括在杆314的远端的可压紧的夹脚316和释放销318(以与图5A-5E的实施例所示的方式同样的方式进行致动)。可以认为图10的实施例是图5A-5E和图9所示的实施例之间的混合设计。图5A-5E和图10的实施例之间的一个区别是,在图5A-5E中,在所述杆中有将所述杆插到所述桩上的孔230。当在图5A-5E中,销234在张力下,所述销是在受剪切状态(in shear),这增加了损坏所述销的可能性。在图10的设计中,没有出现孔230,而是两个夹脚306简单地从所述杆的远侧部分向远侧延伸。销318保持夹脚316在图10所示的叉开的位置,主要是保持它们张开,并保持所述夹脚和所述桩之间的联接。在这个设计中,所述销是在所述夹脚之间受压,而不是在受剪切状态下。一旦拿掉所述销,可在所述杆上施加较小的释放力量,使所述夹脚与所述桩脱离联接。使所述销受压,而不是受剪切,对所述销造成损害的可能性较小。
图11A-11D每幅图分别按顺序显示了包括桩320和致动元件322的可替换实施例的侧视图和透视图,其中桩320的构造从它没有被锁在对应的锁扣321的位置改变到锁定位置,以及其中致动元件322从所述桩松开。为了清楚起见,在所述顺序中没有显示锁扣321,虽然在图11A中显示了锁扣321以展示所述桩、致动元件和锁扣的相对位置。图12A-12C显示了包括锁扣321的锁定和释放顺序。
在图11A中,致动元件322可逆地联接到桩320。致动元件322包括杆324、桩锁定防止元件326和桩锁定致动器328。桩320包括桩锁定元件330。图11A图示的是在将所述桩拉向所述锁扣之前,各部件的初始构造。要有效地缩短所述锚定元件(图中未示),在近侧方向上缩回杆324。桩锁定防止元件326开始时与桩锁定元件330卡合,因此杆324的近侧的缩回造成桩320的近侧运动。继续朝近侧牵拉杆324,直到将桩320拉入到锁扣内,如图12A所示。在图12A中,所述桩还没有锁到所述锁扣上,桩锁定元件330在锁扣锁定元件332的近侧。要将桩320锁到锁扣321上,致动单独的致动器(未示)以在近侧方向上缩回桩锁定防止元件326,以使桩锁定防止元件326脱离桩锁定元件330,如图11B和12B所示。可替换的是,杆324和桩锁定防止元件326可以以这样一种方式卡合,使得施加在杆324上的连续的近侧力将使桩锁定防止元件326与桩锁定元件330脱离。因为所述锚定元件的记忆构造比它完全扩张和展开的构造长,一旦桩锁定防止元件326与桩锁定元件330脱离,所述锚将试图恢复到它狭长的记忆构造下。因此,桩320开始在远侧方向上移动。桩320在远侧上的移动使桩锁定致动器328向桩锁定元件330施加径向向外的力,将它移动到图11C和12C所示的锁定的构造下。可替换的是,或者除此之外,一旦锁定防止元件326与桩锁定元件330脱离,杆324的连续近侧缩回使桩锁定致动器328在桩锁定元件330上施加径向朝外的力。桩320的连续远侧移动使桩锁定元件330与锁扣锁定元件332卡合,将桩320锁在锁扣321上。所述锁定防止所述桩进一步相对于所述锁扣的向远侧移动,将所述锚锁定在在轴向上压缩和完全展开的构造下。现在可以从患者那里从近侧抽回致动元件322并将它去掉。
图13显示的是桩340和夹342的可替换实施例,它包括可变形元件344。图14A-14E显示的是将桩340锁到锁扣348上以及将夹子342从桩340上松开的顺序。与上文描述的实施例类似,杆(图中未示)附接到夹子342上。在图14A所示的位置中,可变形元件344的近侧端卡合桩340的表面元件346。随着向近侧牵拉所述夹子,这个卡合结构(engagement)将所述夹子保持在所述桩内。随着向近侧牵拉所述夹子,这个卡合结构还向近侧牵拉所述桩。随着所述致动器的致动,所述线缆将所述桩和夹子拉入锁扣348内,如图14B所示。从图14C所示的位置连续致动使锁扣348的齿350与可变形元件344卡合并使之变形。可变形元件344允许齿350与凹槽352卡合,以锁住所述锁扣和桩。这个步骤还将可变形元件344从与表面346的卡合中释放出来,从而将所述夹子从所述桩上放开,如图14D所示。这个步骤因此还将所述杆和夹子从所述桩上放开。图14E显示的是从所述桩在近侧完全撤回的夹子。
图15A、15B、16A和16B图示的是所述桩锁定和释放机构的可替换实施例。图15A-16B中的实施例的工作方式与上文描述的工作方式类似,因为致动致动器来牵拉所述致动元件或者杆,将所述桩拉向所述锁扣,锁住所述锚定元件。杆354包括与图6A和6B的实施例中的夹子类似的夹子。图15A是在杆354已经被致动且向近侧牵拉使得锁扣352的齿358与桩360的凹槽362锁在一起之后的立体图,图15B是其侧视图。在图15A和15B所示的位置之前,杆354的表面356防止齿358与所述桩中的凹槽锁在一起。在所述杆远侧端的夹子与所述桩的可变形元件卡合在一起,使得所述杆的连续致动使所述可变形元件变形,并从所述杆松开所述桩。然后,通过连续致动所述致动器可以从患者那里移去这个杆。可替换的是,可以在所述实施例中包括与图5A-5E中的销234类似的销,使得当期望从所述桩松开所述杆时,拿掉所述销,如前文所描述的。
图16A和16B图示的是图15A和15B中锁在一起的所述桩和锁扣的解锁。这个解锁步骤必须在将所述心脏瓣膜从所述输送系统释放之前进行。将杆354推向远侧,促使所述杆的表面364(解锁元件)卡合齿358并使齿358脱离所述桩中的凹槽脱离。所述杆连续向远侧的移动在远侧方向上推动所述桩,这样拉长了所述锚定元件。
在一些实施例中,所述指部可以由热固为记忆扩张的构造的合金制成。所述杆可以包括,例如,不锈钢。所述外管可以例如是由热收缩聚合物制成,但是可以是任何适当的材料。所述外管增加了所述指部纵向上的强度,当处在有效地缩短所述锚定元件的过程中所施加的力之下时,这是有利的。
在上文描述的实施例中,参考的是一种手柄放置在对象体外的输送系统,它用于控制所述致动元件和所述鞘的致动。此处描述的医疗植入体的展开可以由所述手柄上的致动器(例如,旋钮、操作杆)来控制,它由医生致动来控制所述装置的展开。可能会希望能够用尽可能少的致动器来执行多个展开步骤以简化其输送和扩张过程。可能会进一步希望用单个的致动器来执行某些展开步骤,甚至可能用单一类型的运动(例如,在单方向上转动旋钮)致动单个致动器来执行所述展开步骤的多个部分。这样可以使医生做手术更容易,因为用于致动所述手柄致动器的手不需要离开所述致动器去执行多个步骤。在下文描述的输送系统的一些实施例中,用所述输送系统的手柄上的单个的致动器来执行除去所述锚定元件的鞘并锁住所述桩和锁扣的致动步骤。在所述手柄上有可以执行多个展开步骤的单个的致动器可以简化整个手术。使用单个的致动器来控制多个展开步骤还可以确保所述步骤是按特定的顺序执行的,并确保在第一步骤发生之前不会出现所述第二步骤。
在此处描述的实施例中,其中单一类型动作的单个致动器的致动移动多个输送系统部件,可以执行所述单一类型动作来移动一个以上的输送系统部件,而不用执行其它任何中间的致动步骤。在一些实施例中,用户可以停止单一类型运动的致动器的致动,然后继续该致动。单一类型动作包括其中在一段时间内没有任何致动的实施例。也就是说,用户可以开始致动所述致动器,等待一段时间(例如,基于成像技术,判断所述医疗装置的位置是否足够),然后继续致动所述致动器。这是属于此处描述的“单一”类型的动作。
当所述可致动的部件彼此独立致动时,或者当它们在手术的某些部分独立致动而在手术的其它部分是同时致动时,或者当它们必须同时致动但是移动速度不同时,使用单个的致动器来致动输送系统的多个部件潜在地会有问题。下文提供的输送系统,其中单个致动器的致动,致动了多个输送系统部件,其中所述多个部件中的第一个和所述多个部件中的第二个分别独立于彼此地致动。在一些实施例中,所述第一和第二部件也适于成同时致动,在一些实施例中,当它们都被致动时,速度不同。
在所述输送系统的一些实施例中,使用单个的致动器,不仅在除去鞘过程中(例如,如图3B-3F中的示例方法所示)向近侧缩回所述鞘,还向近侧缩回联接到所述桩的所述致动元件。也就是说,以单一方式致动单个的致动器,不仅去掉所述植入体的鞘,还将所述植入体锁在完全展开并锁定的构造下。在所述输送系统中包含单个的致动器,可以在一个方向或者以一种方式致动所述致动器,不仅从所述鞘中展开所述植入体还将所述植入体重新配置到它最终展开的构造下,这可以极大地简化了医生的展开手术。
在展开所述植入体的第一部分期间,仅在近侧方向上牵拉所述鞘,这样除去所述植入体的鞘。在展开所述植入体的第二部分期间,仅向近侧牵拉所述桩,这使所述桩朝向所述锁扣移动,以将所述锚定元件锁在锁定的构造下。在所述手术的第三部分,在近侧方向上牵拉所述鞘和可逆地联接在所述桩上的致动元件,这样的结果是所述鞘和致动元件的速度可变。这个单一的致动器因而必须不仅取决于多个输送系统部件的从属运动和还取决于它们的单独运动。
图17A-17D图示的是示例的输送系统,其中手柄上的单个致动器有选择地致动多个输送系统部件。虽然这个输送系统设计可以被用来有选择地致动大多数类型的医疗装置输送系统中的多个输送系统部件,但是将根据置换心脏瓣膜的展开对其进行描述。另外,尽管所述单个致动器可适于致动与此处描述的部件不同类型的部件,但是在此将它描述成控制鞘和致动置换心脏瓣膜的一部分的致动元件的运动。
图17A-17D显示的是输送系统370的部件,它们容放在手柄壳体内(图中未示),包括外部管380、回转致动器372(适于由用户致动)、导螺杆374、杆托架376、杆托架螺丝378、鞘托架384、鞘托架螺丝386。杆托架376的近侧移动使杆朝近侧方向上移动,造成指向近侧的力量施加到此处所描述的桩上(桩牵引器托架206的远侧运动造成指向远侧的力量施加在所述桩上)。鞘托架384的近侧运动使所述鞘向近侧缩回,以除去所述植入体上的鞘(鞘托架384的远侧运动使所述鞘向远侧移动,以重新给所述植入体套上鞘)。在一个实施例中,在所述鞘的近侧粘接有一个适配器,所述鞘的近侧端螺合在所述鞘托架上。通过转动所述导螺杆使所述鞘托架移动因此直接使所述鞘移动。在一个实施例中,所述杆粘在海波管(hypotube)内,该海波管插在力量限制构件上,该力量限制构件直接附接在所述杆托架上。所述杆托架的移动因而移动所述杆。回转致动器372的转动将旋转运动转化为杆托架螺丝378和鞘托架螺丝386的直线运动。
管380包括内阴螺纹(internal female thread),该内阴螺纹包括沿着管380的两个部分的直线形阴螺纹383和沿着设置在所述直线形阴螺纹部分383之间的所述管的一部分的局部螺旋形状的阴螺纹382。杆托架螺丝378和鞘托架螺丝386都包括与螺丝374的阴螺纹卡合的内阳螺纹,并让致动器372的转动转化成杆托架螺丝378和鞘托架螺丝386的移动。鞘托架螺丝386包括在图17A所示的构造中,卡合直线形阴螺纹383的小凸块385。鞘托架螺丝386还具有与鞘托架384的内阴螺纹卡合的外阳螺纹387(见图17D)。图17A显示的是在这样一种构造下的输送系统,其中所述植入体套在所述鞘内,所述桩没有锁在所述锁扣上。致动器372开始时的转动促使鞘托架螺丝386在近侧方向上线性地运动。因为阳螺纹387和鞘托架384内的阴螺纹之间的相互作用,鞘托架螺丝386的近侧运动引起鞘托架384的近侧运动,如从图17A到图17B的变化所示。这个运动造成鞘的近侧运动,诸如需要开始去掉所述植入体的鞘以允许它进行自扩张。
但是,致动器372开始时的转动不会转换成杆托架376的近侧运动。致动器372开始时的转动使杆托架螺丝378向近侧运动,但是因为杆托架螺丝378的小凸块(图中未示)类似于鞘托架螺丝上的小凸块385,杆托架螺丝在外管380内转动。杆托架376具有与杆托架螺丝378上的阳螺纹379相匹配的内阴螺纹。这些螺纹使杆托架螺丝378可以在杆托架376内转动,而不会导致所述杆托架向近侧运动。致动器372开始时的转动从而导致杆托架376不能动,如从图17A到17B的变化所示。随着开始将所述鞘拉回,所述杆不会拉在所述桩上。
在图17B的构造中,托架螺丝372的两个小凸块都与各自的直线形阴螺纹383对准。因而,致动器372的连续转动会引起托架螺丝386和378在近侧运动。由于所述托架和它们各自的螺丝之间的螺合关系,两个托架都在近侧方向上运动。这在从图17B到17C的变化中有说明。在这部分手术中,所述鞘和所述杆都被在近侧方向上牵拉。
在图17C的构造中,底部小凸块385(未示)卡合螺旋形螺纹382。致动器372的连续转动因而会引起鞘托架螺丝386相对于外管380转动。这样将鞘托架螺丝386不与鞘托架384螺合,如图17C至17D的变化所示。这样导致所述鞘托架不在近侧方向上运动(即,空转)。但是,杆托架376和杆托架螺丝378之间的螺接相互作用转化为杆托架376的近侧运动,如从图17C到图17D的变化所示。在这部分手术过程中,所述杆正被向近侧牵拉,但是没有致动所述鞘。
也可以通过在相反方向上转动所述致动器使所述托架可逆地运动。
应当注意的是,导螺杆374上的阴螺纹可以沿着所述螺丝的长度具有不同的螺距,如图17A-17D所示(虽然导螺杆374上的螺纹的螺距也可以沿着导螺杆374的长度不变)。如图所示,在所述鞘托架螺丝与导螺杆374相互作用的地方的螺距比所述杆托架螺丝与导螺杆374相互作用的地方的螺距大。这样的结果是,在从图17B到17C的变化过程中,所述鞘托架移动的距离比所述杆托架移动的距离大。因此,图17A-17D图示的不仅是空转,而且还是在单个致动器(例如,回转致动器202)致动的基础上两个运动的输送系统部件以不同速度运动。
图18A-18D图示的是带阳螺纹的元件412在带阴螺纹的元件400上的一系列运动,所述带阴螺纹的元件400具有变化的螺距和变化的直径。图17A-17D的导螺杆374可以具有带阴螺纹的元件400的变化的螺距和变化的直径,图17A-17D中的托架螺丝可以包括带阳螺纹的元件412的特征。402段的螺距比404段和406段的螺距小,而406段的直径比402段和404段的直径大。阳螺纹410的引导部分的高度较大(见图18D),这样使它可以与阴螺纹406、404以及402卡合。阳螺纹408的高度比所述引导部分的高度小。阳螺纹408足够大到能卡合阴螺纹406,但是不能卡合404或者402。这个设计使阳元件412在带阴螺纹的元件400的长度上的运动程度可以变化。由于螺距的差异,当凸元件412螺入在406段时的运动距离比螺入在402段时运动的距离大。这样可以允许输送系统部件在第一速度下运动,接着在第二速度下运动(在这种情况下,所述第二运动速度小于所述第一运动速度)。这种可变螺距的设计可以包括在此处描述的任意输送系统中。
图19图示的是圆筒形凸轮(barrel cam)的设计,以与图18A-18D所示的设计类似的方式以可变的螺距来操作。这两个实施例的一个区别是,在图19的实施例中的螺纹433和435集成在圆筒壳体421中,而不是在中心导螺杆上。如图19所示,套鞘托架425在第一螺纹433上转动,杆托架423在圆筒壳体421中的第二螺纹435上转动。通过使所述螺距角度成为0或者接近0,达成空转,因此,所述托架转动,但是不在圆筒壳体421内进行运动转换(或者转换一个最小量)。每个托架还包括用于沿着螺纹433和435的小凸块429。所述托架还包括用于导引管道431的孔427。
图20A-20C图示的一种用于空转的可替换的设计,包括手柄壳体452、一对齿轮454、回转致动器456、杆导螺杆458、杆托架460、杆托架弹簧462、杆托架螺丝464、套鞘导螺杆466、鞘托架468、鞘托架螺丝470、鞘托架弹簧472。回转致动器456转动两个齿轮454,一个齿轮啮合到杆导螺杆458,一个啮合到套鞘导螺杆466。每个导螺杆上的不同螺距会使杆螺丝464和套鞘螺丝470有不同的直线运动速度。在图20A所示的初始构造中,弹簧462被完全压缩,弹簧472没有负荷。致动器456的转动使导螺杆458和466转动,引起杆螺丝464和套鞘螺丝470向近侧运动。在套鞘托架468和套鞘导螺杆466之间压缩弹簧472的阻力使套鞘托架468随着套鞘螺丝470的近侧运动,如图20A和20B之间的转换所示。给弹簧462解压的力使杆托架460保持静止,而杆螺丝464向近侧运动,如图20A至图20B的转换中所示。
当杆螺丝464到达杆托架460的近侧时,致动器456的连续转动使所述两个托架都运动,如图20B所示(两个托架都在运动)。致动器456一继续致动,挡块(图20C中未示)使套鞘托架468停止向近侧运动。致动器456的连续转动引起鞘托架螺丝470(但不是鞘托架468)的连续运动以及弹簧472的压缩。这样允许通过杆托架460向近侧运动而不用所述鞘的动作来锁住所述锚。
在反方向上致动致动器456,通过杆托架460向远侧动作解锁所述锚。弹簧472的压缩限制了套鞘托架468的动作,直到套鞘螺丝470完全位于套鞘托架468内。然后所述两个托架向远侧移动到一起,直到杆托架460到达挡块(图中未示),这导致杆螺丝464向远侧运动,而杆托架460不动,弹簧462被压缩。
图21-22图示的是使所述杆和所述外部鞘的动作相分离的示例设计。在图21中,将单个的致动器啮合在齿轮上,在齿轮的近侧表面上带有凸轮。所述凸轮使附接在导螺杆上的离合器卡合/脱离。当所述离合器卡合时,所述导螺杆转动,使托架(图中未示)根据所述致动器的运动方向向近侧或者远侧移动。当所述离合器没有被卡合时,所述导螺杆不转动,所述托架静止。
在图21中,(所述杆或者鞘的)螺母502经由与托架504中的凹特征508啮合的凸片506连接到(所述杆的或者鞘的)托架504上。随着导螺杆510的转动,螺母502与托架504之间经由凸片506的啮合使托架504与螺母502一起转动(通过用致动器,图中未示)。螺母502具有沿着壳体中的路径514行进的小凸块512。路径514中的凹凸部(jog)516使螺母502相对于托架504在逆时针方向转动。这个动作使凸片506与凹特征508脱离,从托架504上松开螺母502。由于螺母502和托架504不再是结合在一起,所述致动器的连续致动(例如,转动)仅使螺母502运动。在相反方向上转动所述致动器使螺母502往后运动到与所述托架接触,重新使螺母凸片506位于所述托架内,然后托架504与螺母502一起运动。
图22显示的是包括导螺杆602的输送系统600,区域606具有阴螺纹,而区域610没有螺纹。鞘托架604包括与导螺杆602上的阴螺纹606啮合的阳螺纹614。鞘托架604还包括锁定元件608,它适于与导螺杆602上的锁定凸缘(lock lip)612卡合,以将托架604锁在导螺杆上,防止托架604在远侧方向D上运动。手柄(图中未示)上的致动器的转动使导螺杆602转动,这样引起托架604向近侧运动。这样在近侧方向缩回所述鞘,而不移动所述桩。连续的近侧运动使锁定元件608与锁定凸缘612卡合并且锁住。因为所述导螺杆在区域610中没有任何螺纹,导螺杆602的连续转动不会使托架604运动。
图23A和23B图示的是一个示例的手柄的近侧部分,所述手柄用于展开图4和图5A-5B中的心脏瓣膜。所述手柄包括壳体620、回转致动器形式的第一致动器624、滑动门622和第二致动器626,只有当门622已经从图25A的第一位置朝前滑动到图25B的第二位置时,才可以操作所述第二致动器。在这个实施例中,回转致动器624控制所述鞘的运动(诸如图3B-3C所示之类)和图4与图5A-5B所示的致动元件206B的运动。在一个实施例中,致动器624控制如图17A-17C所示的所述鞘和所述致动元件的运动,使得致动器624的致动独立地以及从属地使所述鞘和致动元件移动。一旦通过将桩锁在锁扣上来锁住所述锚定元件,医生将门622滑动到图23B所示的位置,并致动第二致动器626。致动器626的致动缩回图4中的销组件236,这样使三个销234从穿透所述桩和致动元件的所述孔中拿掉,解除所述桩与致动元件206B的卡合。
在一个实施例中,致动器626的连续致动还进一步将致动元件206B从图5B所示的位置缩回到图5E所示的位置。图23C图示的是示例的输送系统的手柄630的放大部分,该部分具有允许致动器626连续致动的设计,以进一步缩回致动元件206B(图23A和图23B的第二致动器626未示)。所述锁定和套鞘驱动环经由所述导螺杆致动所述锁定和套鞘托架,与参考图17A-17D所描述的方法类似。手柄630包括锁定和套鞘驱动环631、锁定和套鞘导螺杆螺丝632、锁定托架633、释放销托架635、空转圆筒629、释放销芯棒636(所示为在海波管内)、杆致动芯棒634(所示为在海波管内)和力限制器638。力量限制器638包括轨道637,其中当向近侧牵拉释放销托架635时,释放销托架635移动。所述释放卡箍致动一个单独的较小的导螺杆639(正常情况下由锁定托架633正常地驱动),向近侧牵拉释放销托架635。当医生准备好要拿掉所述销时,致动所述手柄上的第二致动器(图中未示),这样卡合所述释放导螺杆639,使它转动。这在轨道637内从近侧牵拉释放卡箍636,使得释放销芯棒636被向近侧拉回,从所述桩上松开所述销,并解除所述杆与所述桩的联接。所述第二致动器的连续致动继续牵拉所述释放托架,直到它到达力限制器638的近侧端。当托架635在力限制器638的近侧的最底时,它移动所述力限制器的一部分,在所述部分中它位于相对于所述力量限制器的其他部分的近端。这样使得杆芯棒634被向近侧牵拉,在近侧方向上牵拉所述杆。因此,可以用所述第二致动器来释放所述销以及继续在近侧方向上拉回所述杆。
可替换的是,可以设计所述手柄,在拿掉所述销之后,可以进一步致动回转致动器624,以向近侧缩回致动元件206B。然后从患者身上去掉所述输送系统。
此处所描述的医疗植入体,在整个植入体已经开始从所述鞘中展开时,可以再折叠和再至少局部套回所述鞘内。这是因为在所述植入体从所述鞘中展开之后,所述植入体的至少一部分保持可逆地地联接到所述输送系统的一部分(例如,见图3F)。即使是在所述锚定元件锁在完全展开的配置下之后,在一些实施例中,可以从所述锁扣上解开所述桩,之后可以将所述锚定元件重新套入所述鞘中。能够在将植入体从输送鞘或者导管中展开好之后重新把它装入鞘内是有利的,因为它允许将所述植入体从患者体内移走或者按照需要将它重新定位于患者体内。例如,一旦置换心脏瓣膜是在图3F所示的构造下,该置换心脏瓣膜的功能和/或位置可用(随着所述锚开始被锁在扩张后和锁定后的构造下,持续可用),然后可以被重新套上鞘并且接下来依照需要被重新定位或者从患者体内取出。
虽然此处是参考置换心脏瓣膜来描述执行所述重新套上鞘的重新套上鞘的过程和输送系统,许多医疗装置可以受益于此处描述的重新套上鞘的辅助部。例如,在从输送导管或者鞘中展开可扩张的支架之后保持可逆地地联接到所述输送系统的可扩张的支架可以受益于具有此处描述的包含在所述输送系统中的任意一种重新套鞘辅助部。
要重新给所述心脏瓣膜套上鞘,相对于所述导管向远侧推进所述鞘。可替换的是,可以相对于所述鞘向近侧抽回所述导管。所述鞘相对于所述导管的远侧运动造成联接在所述导管远侧的所述指部在径向上朝里折叠。这样造成所述锚的近侧端折叠起来。所述鞘连续的远侧运动使所述心脏瓣膜的其余部分延长并折叠,允许所述鞘重新捕捉住所述锚定元件。
在所述锚定元件包括编织的材料的实施例中,所述鞘的远端的前进会导致所述锚的近侧端的某些部分被钩在或者卡在所述鞘的远侧端上。这样会阻止重新给它套上鞘或者它会降低重新套上鞘的效率。
图24图示的是包括鞘644、输送导管646和套鞘辅助元件642的可替换输送系统640。套鞘辅助元件642是编织的结构,并可以与此处描述的编织的锚定元件类似。套鞘辅助元件642通常具有记忆构造,其中套鞘辅助元件642的远侧端的直径比锚定元件649的近侧直径大。所述输送系统包括可逆地联接在置换心脏瓣膜648(为了清楚起见,置换心脏瓣叶没有示出)的近侧区域的指部647(仅可以看见两个)。套鞘辅助元件642的近侧端联接在输送导管646的远侧端。指部647还联接在导管646的远侧,通常是在套鞘辅助元件642的“内部”或者相对于它在径向上向内。图24显示的是所述鞘已经抽回让所述锚定元件扩张成记忆构造之后但还没有被有效地缩短的置换心脏瓣膜。
要重新给所述植入体套上鞘,相对于所述导管和所述植入体在远侧推进。这可以通过致动手柄的致动器来完成,如上文所描述的。因为所述套鞘辅助元件的近侧端固定在所述输送导管的远侧端,所述鞘的远侧端可以容易地经过所述套鞘辅助元件的近侧端,而不被钩住。所述鞘的连续的远侧运动造成至少所述套鞘辅助元件的远侧部分延长,并局部地在直径上折叠。随着所述套鞘辅助元件延长,所述套鞘辅助元件的远侧端相对于所述锚的近侧端而向远侧移动。所述鞘的连续的远侧运动继续折叠所述套鞘辅助元件的远侧端,至少所述套鞘辅助元件的远侧区域将卡合至少所述锚的近侧端。所述套鞘辅助元件因而会提供一个表面,所述鞘可以通过所述表面,而没有钩在所述锚的近侧端的风险。所述套鞘辅助元件可以额外地将径向上朝内的力量施加到所述锚的近侧端,辅助所述锚的近侧端的折叠。随着继续从远侧推进所述鞘,将所述锚折叠,并重新套入所述鞘内。在一些实施例中,所述套鞘辅助元件是聚合物网。
在一些实施例中,所述套鞘辅助元件也可以作为栓塞过滤器。一旦摘掉鞘,所述套鞘辅助元件可以捕捉朝下游流到目标位置的栓塞,而允许血液通过所述辅助元件。在这样的实施例中,所述套鞘辅助元件的远侧端可以被配置和设置为具有记忆直径,该记忆直径尽可能地接近要放置所述套鞘辅助元件的远侧的管腔直径。栓塞过滤器的示例材料是现有技术中已知的。
图25-28图示的是具有可替换的套鞘辅助元件660的可替换的输送系统。套鞘辅助元件660包括三个(3)可折叠的叶片662。所述叶片在它们的近侧端在轮毂664上彼此固定在一起(见图28)。轮毂664可以相对于指部666和导管668在轴向上运动,但是导管668的远侧区域包括轮毂挡块670,其适于与所述轮毂卡合,并防止所述轮毂相对于所述轮毂挡块向近侧运动。随着鞘(图中未示)向远侧前进到导管668上,开始折叠指部666。随着所述指部在径向上朝里折叠,然后所述轮毂可以向远侧移动到所述指部上。随着所述指折叠,所述锚的近侧端开始折叠,所述轮毂继续向远侧推进。最终,叶片662的远侧端覆盖在所述锚的近侧端,然后所述鞘可以前进到所述锚,而不会被钩在所述锚的近侧端。在一些实施例中,所述叶片适于随着所述鞘施加力在它们之上,朝内折叠在其自身上。
在图26所示的实施例中,套鞘辅助元件660包括可选的指部开孔672,指部开孔672适于允许所述指部从中穿过。可以将开孔672设计成任意形状(例如,矩形、圆形等等),以允许相对于所述指部容易地向远侧移动所述轮毂。在图28所示的实施例中,所述叶片具有可选的狭缝674,以辅助它们的折叠。
图29显示了套鞘辅助元件680的实施例,在它们的远侧端包括臂部682和齿684。所述齿适合卡合所述编结的顶部(crown),所述编结的顶部形成于一股在所述编结(或者非编织的锚的其它近侧区域)的端部转弯的地方,并允许所述鞘向远侧前进到所述锚上。每个臂部682可以具有任意数目的齿684。所述臂部适于响应从所述鞘施加的力,使得将它们改变成具有弯折部的第二构造,使得所述臂部的远侧部分在径向上朝里弯折,以卡合所述锚的近侧端。
图30显示的是套鞘辅助元件670的可替换实施例,它包括支架元件672。套鞘辅助元件670的功能类似于图26所示的实施例,但不是由编织的材料构成。所述支架例如可以由合金或者支架领域内已知的任何其它适当材料形成。
图31显示的是套鞘辅助元件680的可替换实施例,其包括卷曲元件682(锚未示)。如前文在其它实施例中所描述,卷曲元件682的近侧端可以联接到轮毂,或者每个卷曲元件可以个别地附到所述导管上。随着向远侧推进所述鞘,所述鞘的力使所述卷曲元件的远侧端不再卷曲并伸直。所述伸直的元件的远侧端延伸到所述锚的近侧端之上并在其远侧,允许所述鞘前进到所述锚的近侧端上,而不会被钩在所述锚的顶部上。所述卷曲的元件例如可以由不锈钢或者其它任意适当的材料制成。
在图32和33所示的可替换实施例中,套鞘辅助元件684包括多个臂部686(在图32和33中显示了十二个臂部),每一个臂部都具有凸出锁定元件688的远侧端。每个臂部686包括凹入锁定元件690,设置在比凸出锁定元件688更靠近轮毂692的地方。在图32和33中,所述凸出锁定元件具有箭头形状,所述凹入锁定元件是窄缝形状。轮毂692其中包括开孔694,允许控制线696从中穿过。控制线696在其远侧端具有加大的元件(图中未示),防止所述加大的元件被向近侧牵拉穿过开孔694。在所述输送构造中,每个臂部686从轮毂692向远侧延伸,每个臂部远离所述窄缝的远侧区域包覆在所述锚的顶部周围(见图33)。凸出锁定元件688与凹入锁定元件690卡合。当重新给所述置换心脏瓣膜套上鞘时,指向近侧的力施加在控制线696上,这样防止所述顶部在径向上向外延伸,从而允许所述鞘在远侧前进到近侧的顶部上,而不会被卡住。可替换的是,不需要近侧力,臂部686和所述锚的顶部卡合防止所述顶部卡在所述鞘上。在所述轮毂上的指向近侧的力量将所述箭头从所述窄缝中释放出,从所述锚上放开所述臂部。这样将所述植入体从所述臂部放开。
在图34-37所示的可替换的实施例中,所述输送系统包括线或者缝线700,在它们的近侧联接在输送系统部件上(例如,导管702的远侧端,手柄中的致动器,等等),并且每一个都被包覆在所述锚的顶部周围。所述线或者缝线700的远侧端具有诸如球形元件之类的加大的元件704,其适于与导管702的外表面中的环状止动部706卡合。鞘708保持加大的元件704和止动部706的卡合。所述线或者缝线700的远侧端可以简单地包括一个锁定元件,而所述导管的外表面可以包括第二锁定元件。缝线700给所述顶部提供径向上朝内的力,在重新套上鞘的过程中帮助所述鞘延伸在所述顶部之上。一旦相对于所述导管向近侧牵拉所述外部的鞘,从所述止动部释放所述加大的元件,可以从所述锚的顶部释放所述线/缝线700。在图35所示的可替换实施例中,所述导管包括多个止动部706。
图38-41图示的是套鞘辅助器710的可替换实施例,其包括附接在导管714的远侧的多个臂部。所述臂部包括两种类型的臂部718和720,其中臂部718稍微比臂部720长。所述臂部由线段(wire segment)形成,在臂部的远侧端有弯折,其中所述臂部的两端在套鞘辅助器710的近侧端726处联接在一起。臂部718从所述导管延伸到所述锚,其远侧端编在所述锚的编结中。也就是说,臂部718的远侧端在径向上放置在所述编织的锚内,如从图39-41可见。臂部718附接在加强元件722上,加强元件722比臂部718和臂部720都短。加强元件722在附接点724附接在臂部718,所述附接点例如可以是焊点。可以看到,加强元件722放置在臂部718的线段内,增加了臂部718的强度。套鞘辅助部还包括臂部720,所示的是比臂部718短,虽然它们可以基本上都是同样的长度。如图38所示,两个臂部720在附接点724附接在一起。臂部720被定位在径向上朝所述编结的外部,不像臂部720,臂部720被编入所述编结中并在径向上放置在所述编结内。随着所述鞘向远侧向前进,臂部720有助于在所述编结上施加在径向上朝内的力。臂部718也有助于在所述编结上施加在径向上朝内的力,所述两组臂部确保所述鞘的远侧端不会钩在所述锚上。
在一个可替换实施例中,所述编织的锚的近侧顶部是热固在这样一个构造下,其中所述顶部在径向上朝里弯折(相对于所述编结的纵轴及相对于所述锚的其余部分),以在所述重新套上鞘的过程中的辅助鞘套上。所述顶部朝里弯折,以防止所述鞘钩在所述顶部上。
虽然本说明书是结合上文描述的示例实施例来描述的,但是那些本领域技术人员将会理解可以对它进行各种修改。相应地,本发明的范畴不受上述示例实施例的限制。
Claims (13)
1.一种医疗装置系统,包括:
输送系统,所述输送系统具有设置在对象外部的壳体,
其中所述壳体包括致动器,
其中所述输送系统被配置和设置成,使得所述致动器适于以独立于第二输送系统部件地移动第一输送系统部件,并且
其中所述输送系统进一步被配置和设置成,使得所述致动器也适于以独立于所述第一输送系统部件地移动所述第二输送系统部件。
2.根据权利要求1的医疗装置系统,其中所述输送系统进一步被配置和设置成,使得所述致动器进一步适于同时致动所述第一输送系统部件和所述第二输送系统部件。
3.根据权利要求2的医疗装置系统,其中所述致动器适于当同时致动所述第一输送系统部件和所述第二输送系统部件时,以不同的速率致动它们。
4.根据权利要求1的医疗装置系统,其中所述输送系统被配置成,使得所述致动器的致动使所述第一和第二输送系统部件在同一个方向上移动。
5.根据权利要求1的医疗装置系统,其中,所述输送系统被配置成,使得所述致动器的致动按特定的顺序致动所述第一和第二输送系统部件。
6.根据权利要求1的医疗装置系统,其中所述致动器是单个的致动器元件,并且其中所述致动器被配置成,使得所述致动器以单一类型动作的致动既使所述第一输送系统部件的致动独立于所述第二输送系统部件,也使所述第二输送系统部件的致动独立于所述第一输送系统部件。
7.根据权利要求1的医疗装置系统,其中所述第一输送系统部件是输送鞘,其中所述医疗装置系统包括适于穿过所述输送鞘、经皮输送到患者体内的目标位置的医疗装置,其中所述致动器适于,以独立于所述第二输送系统部件地并在独立移动所述第二输送系统部件之前移动所述输送鞘。
8.根据权利要求7的医疗装置系统,其中所述的第二输送系统部件可逆地地联接到所述医疗装置的一部分。
9.根据权利要求8的医疗装置系统,其中所述致动器适于,在致动它时,向近侧独立地移动所述鞘和所述第二输送系统部件。
10.根据权利要求9的医疗装置系统,其中所述致动器的致动被配置为向近侧缩回所述鞘,以允许所述医疗装置扩张,并其中所述致动器的进一步致动向近侧缩回所述第二输送系统部件。
11.根据权利要求1的医疗装置系统,其中所述输送系统和致动器被配置为,使得所述致动器以单一类型动作的运动使所述第一输送系统部件独立于所述第二输送系统部件地移动,并使所述第二输送系统部件独立于所述第一输送系统部件地移动。
12.根据权利要求11的医疗装置系统,其中所述单一类型动作是所述致动器的转动。
13.根据权利要求11的医疗装置系统,其中所述单一类型动作使所述第一输送系统部件独立于第二输送系统部件地移动,并使所述第二输送系统部件独立于所述第一输送系统部件地移动,而在所述第一输送系统部件的独立移动和所述第二输送系统部件的独立移动之间不进行任何中间的致动步骤。
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