CN108778388B - 凸轮控制的多方向可操纵手柄 - Google Patents
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Abstract
本文公开的是导管控制手柄,该导管控制手柄包括用于控制附接的导管的弯曲的圆周角度和径向弯曲大小的各种基于凸轮的机构。控制手柄能够包含:限定在远侧方向和近侧方向上延伸的纵向轴线的壳体;相对于壳体可轴向移动并且还相对于壳体绕纵向轴线可旋转地移动的凸轮构件;至少一个从动件,所述至少一个从动件与凸轮构件接合,使得所述至少一个从动件响应于凸轮构件的移动相对于手柄移动;以及联接到至少一个从动件并且向远侧延伸离开手柄并进入可操纵导管的拉线。至少一个从动件能够包含多个轴向滑动件、万向节机构、球窝机构或其他机构。
Description
技术领域
本公开涉及用于操纵附接的导管或其他经腔装置的控制手柄。
背景技术
经血管技术已经被开发用于使用柔性经血管导管以比心脏直视手术侵入性更小的方式将假体装置(例如心脏瓣膜)引入和植入患者体内。典型的导管控制系统只允许导管的远端的有限弯曲,诸如在垂直于导管的纵向轴线的两个正交轴线上。例如,传统的导管控制手柄可以包括联接到沿导管的一侧延伸的拉线的杠杆或转盘,使得致动杠杆或转盘引起导管的远侧尖端径向地弯曲到纵向轴线的一侧。为了使远侧尖端在其他方向上弯曲,通常需要致动联接到其他拉线的附加杠杆/转盘。因此,多个致动装置通常必须以谨慎的组合或顺序同时被致动,以在期望的圆周方向上产生期望程度的径向弯曲。
发明内容
本文公开导管控制手柄,该导管控制手柄利用基于凸轮的机构以提供附接的导管的改善的操纵性。利用基于凸轮的机构彼此独立地确定导管弯曲的圆周角度和径向大小给予使用者更直接和精细的弯曲控制。一些公开的实施例使用可轴向移动的滑动件作为凸轮从动件,可轴向移动的滑动件沿倾斜的凸轮表面骑行以用于控制导管拉线中的张力,而另一些实施例使用球窝机构作为凸轮从动件,并且又一些实施例使用万向节机构作为凸轮从动件。公开的控制手柄允许对附接的导管的径向弯曲的大小和径向弯曲发生时的圆周角度两者进行独立的控制,无需整个导管在患者体内转动。离合机构也能够被包括以固定圆周弯曲角度同时继续允许径向弯曲角度的调整。
手柄能够包含弯曲旋钮,所述旋钮的旋转引起凸轮构件的轴向调整。弯曲旋钮能够相对于中心轴被固定,该中心轴轴向地延伸穿过凸轮构件并且能够与壳体可旋转地接合以允许弯曲旋钮和中心轴相对于壳体的旋转并且限制弯曲旋钮和中心轴相对于壳体的轴向移动。中心轴能够与凸轮构件接合,使得弯曲旋钮相对于壳体的旋转引起凸轮构件相对于壳体的轴向移动。
壳体还能够包含相对于凸轮构件被固定的位置旋钮,其中所述位置旋钮的旋转引起凸轮构件的旋转调整。位置旋钮和弯曲旋钮能够被定位成邻近手柄的远端或邻近手柄的近端。
凸轮构件能够包括在一个轴向端部处的与(一个或多个)从动件相接的接触表面,并且接触表面能够具有斜率,该斜率根据围绕手柄的纵向轴线的圆周位置在轴向位置上变化。凸轮构件接触表面的斜率能够在围绕接触表面周向移动的轴向位置中逐渐地变化,使得(一个或多个)从动件随着凸轮构件绕手柄的纵向轴线旋转而逐渐地向远侧或向近侧移动。
在一些实施例中,每个拉线被联接到其自身的滑动件或从动件,所述滑动件或从动件响应于其沿能够被旋转和平移的凸轮构件的接触位置而沿手柄中的纵向凹槽滑动。凸轮构件的旋转引起一些滑动件向远侧移动并且一些滑动件向近侧移动,引起弯曲的方向的改变。凸轮构件的线性平移引起所有滑动件都向远侧或向近侧一起滑动,从而引起弯曲的程度的改变。
在一些实施例中,包括球窝机构,使得窝用作从动件并且被联接到拉线,其中窝响应于与凸轮构件的接触绕球铰接。凸轮构件的旋转和平移类似地引起弯曲的方向和弯曲的程度的独立变化。
在一些实施例中,万向节机构能够被包括在手柄中以用作凸轮从动件。拉线能够被联接到万向节机构中的内板,并且内万向节板能够相对于壳体通过与万向节板接触的凸轮构件的旋转或平移而沿多维度被致动。在一些实施例中,滑轮系统能够被包括在手柄中以在向拉线施加张力时提供机械优点。在一些示例中,齿条齿轮机构能够被包括在手柄中以在向拉线施加张力时提供机械优点并且将拉线联接到凸轮/万向节机构,这能够帮助避免对拉线的弯折和损坏。
公开的技术的前述和其他目的、特征和优点通过以下的具体实施方式将会变得更加明显,具体实施方式参考附图进行描述。
附图说明
图1是用于执行经血管手术的示例性凸轮控制的多方向可操纵控制手柄的透视图,诸如用于假体心脏瓣膜的输送导管,其包括沿凸轮的表面骑行并且控制连接的导管的移动的多个滑动件。图21示出联接到导管的图1的手柄。
图2是图1的控制手柄的分解透视图。
图3是用于经血管装置的另一凸轮控制的可操纵导管控制手柄的一部分的透视图,其包括球窝凸轮机构。
图4至图6是包括万向节机构的示例性凸轮控制的多方向可操纵导管控制手柄的透视图。
图7是图4的手柄的侧视图。
图8是图4的手柄的侧剖视图。
图9是图4的手柄的透视剖视图。
图10至图12是示出图4的手柄的各种配置的侧视图。
图13是包括万向节机构的另一示例性凸轮控制的多方向可操纵手柄的透视图。
图14是图13的手柄的侧剖视图。
图15是图13的手柄的侧视图。
图16至图19是示出图13的手柄的各种配置的侧视图。
图20是图示说明用于导管控制手柄的替代性基于万向节的线驱动机构的示意图,所述导管控制手柄使用齿条齿轮机构以在向拉线施加张力时实现机械优点。
图21示出联接到柔性导管的图1的控制手柄,其图示说明使用控制手柄的导管的可操纵性。
具体实施方式
图1和图2图示说明示例性导管控制手柄10,其为附接的导管提供凸轮控制的多方向可操纵性。手柄的远端40能够被联接到经血管的导管(见图21中的系统500)或用于插入患者体内的其他细长的和可操纵的管状装置,而近端41可以包括用于穿过手柄10和附接的导管的其他装置和/或流体的通道的管腔通路。
手柄10能够包含具有倾斜的近侧表面46的凸轮构件16,滑动件22沿倾斜的近侧表面46滑动。滑动件22被限制只轴向移动以使得滑动件用作凸轮从动件。滑动件22能够被联接到沿导管的侧面延伸的拉线,使得滑动件22在狭槽68中的轴向移动施加/改变在关联拉线上的张力。能够包括任意数量的滑动件和拉线。
手柄10能够包括引起凸轮16的轴向平移的第一旋钮42(本文中称为“弯曲旋钮”)、引起凸轮16的周向旋转的第二旋钮60(本文中称为“位置旋钮”)和可选的第三旋钮34(本文中称为“离合旋钮”),可选的第三旋钮34用作离合器或制动器以锁定在由第二旋钮60选择的凸轮16的旋转位置中同时允许通过弯曲旋钮42调整凸轮的轴向位置。
通过旋转弯曲旋钮42,使用者能够使凸轮16相对手柄的其余部分轴向地移动,这引起所有滑动件22轴向地移动相应的距离,这进而引起附接到滑动件的所有拉线的张力共同增大或减小,从而导致附接的导管的远侧尖端的径向弯曲大小的改变(但不一定改变弯曲的导管尖端的圆周角度)。
通过旋转位置旋钮60,使用者能够使凸轮16和其倾斜的端表面46绕手柄的中心轴线旋转,从而导致滑动件22中的一个或多个在狭槽68中向远侧移动和一个或多个其他滑动件在狭槽68中向近侧移动,这取决于倾斜的端表面46的哪部分与每个滑动件22接触。这样能够引起一个或多个拉线的张力的增大和一个或多个其他拉线的张力的同时减小,这引起附接的导管的弯曲的远侧尖端绕其中心轴线枢转并且改变其被径向弯曲的圆周角度(不需要在患者体内旋转整个导管)。
因此,弯曲旋钮42和位置旋钮60中的每一个能够利用单个旋钮的调整来独自地调整所有的滑动件22和相关联的拉线,并且旋钮42和60中的每一个能够产生对导管的远侧尖端的非常不同、但互补的所得到的调整。
在一个示例性方法中,从具有校直远侧尖端的附接的导管开始,使用者首先能够将弯曲旋钮42旋转足够的量以使导管的远侧尖端从校直位置的纵向轴线径向地弯曲至期望角度(例如,从直线弯曲至30度的弯曲角度)。这种弯曲能够是纯径向的,没有周向移动(例如,当远侧尖端位于零度的固定圆周角度时,径向弯曲能够发生)。之后,使用者能够旋转位置旋钮60以使导管的远侧尖端逐渐地改变其被径向弯曲的圆周角度。例如,以一个方向旋转位置旋钮60能够引起远侧尖端的圆周角度的顺时针方向的变化,而以相反的方向旋转位置旋钮能够引起圆周角度的逆时针方向的变化。在保持远侧尖端的径向弯曲程度的同时能够引起圆周角度的这种变化。此外,当位置旋钮60被用于改变远侧尖端弯曲的圆周角度时,导管自身不需要在患者体内被旋转。代替地,导管的远侧尖端从直线在不同的圆周方向上被简单地弯曲而导管的其余部分能够保持静止。
在另一示例性方法中,从具有校直远侧尖端的附接的导管开始,使用者首先能够旋转位置旋钮60以将凸轮16旋转至与导管的远侧尖端的期望弯曲方向对应的选定的圆周位置(例如,从指定参考点逆时针旋转270度)。之后,使用者能够将弯曲旋钮42旋转足够的量以使导管的远侧尖端在期望方向上从校直位置的纵向轴线径向弯曲至期望角度(例如,从直线旋转至30度的弯曲角度)。这种弯曲能够是纯径向的,没有周向移动(例如,当远侧尖端位于270度的固定圆周角度时,能够发生0度到30度的径向弯曲)。而且,在利用位置旋钮60设定期望圆周角度之后,离合旋钮34能够被接合以冻结该圆周角度同时允许远侧尖端使用弯曲旋钮42的径向弯曲。
如图1和图2中所示,手柄10包括远侧鼻锥体12、能够包括弯曲旋钮41和螺纹主体44的弯曲部件14、凸轮16、销18、包括远侧主体48和近侧主体50的带有滑动件凹槽52的固定滑动件导轨20,每个均具有向外突出的销54的滑动件22、带有盘部分56和近侧轴58的后塞25、包括定位旋钮60和带有狭槽/凹槽68的近侧圆柱64的定位部件26、垫圈28、垫片30、外护套32、离合旋钮34、近侧垫片36和形成近端41的近端帽38。也能够包括各种保持器/紧固件(例如,保持环70)。如图1中所示,滑动件22能够沿凹槽52轴向地滑动而其滑动件销54向外突出至凸轮16的径向尺寸。凸轮16被定位在近侧主体50近侧圆柱64之间,使得滑动件销54与凸轮16的倾斜的近端表面46接触。凸轮16能够被联接到定位部件26使得定位旋钮60的旋转引起凸轮旋转,而在同时近侧圆柱64允许凸轮在固定滑动件导轨20和定位部件26之间轴向地滑动。
弯曲部件14的螺纹主体44能够围绕固定滑动件导轨20的远侧主体48被定位并且也被接合到凸轮16以使得弯曲部件14的旋转相对于固定滑动件导轨20和定位部件26的圆柱64轴向地驱动凸轮。
离合旋钮34能够具有接合位置和分离位置。当在接合位置中时,位置旋钮60能够被锁定,使得远侧尖端的圆周角度被固定,同时允许弯曲旋钮42轴向地驱动凸轮16和改变远侧尖端的径向弯曲的大小。当离合旋钮34处在分离位置时,弯曲旋钮和位置旋钮两者都起作用。
滑动件22中的每一个能够被附接到拉线的穿过手柄10向远侧延伸、穿出远端40并且沿附接的导管延伸的一端。手柄10能够包括两个、三个、四个或更多个滑动件和相关联的拉线。在图示的实施例中包括了四个滑动件22,所述滑动件均被彼此周向地相隔约90度。
凸轮16的倾斜的近端表面46能够被配置为在弯曲角度的精细控制和调整弯曲角度所必须的旋钮旋转的最小量之间提供期望的平衡。例如,凸轮上的较陡斜坡引起弯曲旋钮的旋转每一度带来径向弯曲的更大变化,而较小倾斜的凸轮表面提供了对弯曲的精确角度的更精细的控制。
倾斜的端表面46包含滑动件接触表面,该滑动件接触表面具有斜率,该斜率根据绕手柄的纵向轴线的圆周位置在轴向位置中变化。接触表面的斜率能够在围绕接触表面周向移动的轴向位置中逐渐地变化,使得滑动件随着凸轮绕手柄的纵向轴线旋转而向远侧或向近侧逐渐地移动。接触表面能够包含绕手柄的中心轴和/或中心腔周向地延伸的环形表面。接触表面能够包含任意平坦的或不平坦的轮廓,诸如限定不平行于或垂直于手柄的纵向轴线的斜面的平坦表面。
弯曲旋钮42和位置旋钮60能够同时或单独地被旋转。例如,在示例性方法中,这两个旋钮能够同时被旋转(以相同的旋转方向或以相反的旋转方向)。这两个旋钮的同时旋转能够引起凸轮16同时轴向地滑动和周向地旋转,这样引起导管的远侧尖端既改变其径向弯曲的程度又改变其弯曲的圆周方向。
手柄10能够利用一只或两只手被手动地操作。由于旋钮42和60靠近彼此,所以使用者能够利用一只手操作两个旋钮同时握住手柄10。
公开的控制手柄中的凸轮特征的使用能够在选择附接的导管的远侧尖端的期望弯曲位置时提供无限的选择程度(见图21),因为凸轮特征能够提供模拟调整机构。此外,关于控制手柄10,滑动件数量的增加和/或被包括和联接到滑动件22的不同拉线数量的增加能够改善本文描述的模拟控制系统的平滑性。
参考图21,旋转弯曲旋钮42引起导管520沿径向方向弯曲,所述径向方向诸如图21中标示的四个示例性径向方向R1、R2、R3、R4中的任意一个,或所标示方向之间的方向。当凸轮构件16处在其远侧位置时,导管能够被放松和/或不被弯曲,诸如图21中的位置P1所示。当凸轮构件被向近侧驱动时(利用凸轮向近侧移动滑动件),拉线被张紧,从而导致导管径向地弯曲,诸如弯曲至图21中标示为P1、P2、P3、P4的弯曲位置中的任一位置。导管弯曲的圆周角度由位置旋钮42的位置确定。位置旋钮的旋转位置能够对应于弯曲导管在标示为C的方向上的周向移动。例如,如果导管当前在弯曲位置P4,则位置旋钮60度的旋转(同时弯曲旋钮处于静止)能够将导管沿虚线移动到位置P3或移动到位置P5(同时导管不绕其中心纵向轴线旋转)。如果导管当前在非弯曲位置P1,则位置旋钮的旋转不会引起导管的任何移动(甚至不会引起导管绕其中心纵向轴线的旋转),但能够确定当弯曲旋钮随后被旋转时导管将会弯曲的径向方向。通过组合调整弯曲旋钮42和位置旋钮60(同时或一次一个),导管520能够被操纵至图21中的虚线圆内的任意弯曲位置(假设虚线圆表示最大弯曲程度),而无需使导管在患者体内绕其中心纵向轴线旋转(导管在血管内的旋转例如能够损坏血管的内衬)。
图3图示说明另一示例性控制手柄100,其包含:具有远端104和近端106的中心管状轴102、103;固定到轴的远侧部件110;窝112;和安装到窝内部的轴上的球120。远侧部件110包括弯曲旋钮114和带有向近侧延伸的与窝112的远侧接合表面124接触的凸轮指118的凸轮主体116。窝112相对于凸轮指118的旋转取向(例如,被选择成旋转窝)确定窝相对于球120如何倾斜,这确定导管的远侧尖端的圆周弯曲角度。凸轮指118相对于窝112的轴向位置(例如,由弯曲旋钮114的旋转选定)确定导管的远侧尖端的轴向弯曲的大小。窝112具有围绕其外周边的缺口126和凹槽128、130。多个导引线围绕窝周边被联接到窝并且向远侧延伸到导管中。
图4至图12图示说明另一示例性控制手柄200,其包括凸轮构件,所述凸轮构件与万向节机构相接以控制若干不同拉线上的张力。手柄200包含具有远端212和近侧内腔214的壳体210,近侧内腔214容纳包含外万向节环216和内万向节板218的万向节机构。环216相对于壳体210在枢轴接头250处被可枢转地安装,使得环能够相对于壳体围绕穿过接头250垂直于手柄的纵向轴线的环轴线旋转。板218相对于环216在枢轴接头252处被可枢转地安装,使得板能够相对于环围绕穿过接头252垂直于环轴线的板轴线旋转。板轴线和环轴线绕壳体轴线被可旋转地固定,但由于环通过接头250相对于壳体枢转并且由于板通过接头252相对于环枢转,板能够相对于壳体多方向地枢转。
万向节板218包括用于手柄的每个拉线222的线接合器220。可以有两个、三个、四个、五个、六个、七个、八个或更多个拉线222。作为示例图示说明四个拉线222。每个拉线222穿过手柄中的通道226且从远侧开口228延伸出进入附接的导管或其他相似的可操纵装置中。图21示出示例性导管。线222能够可选地围绕万向节板218中的各自的线接合器220成环(loop),如图所示,以使线的端部分224向远侧延伸返回到壳体上的固定附接点。在这类实施例中,线接合器220能够包含圆钉、滑轮或其他特征以帮助线用最小的摩擦力和由于板铰接的扭结而围绕线接合器滑动。这种布置能够提供机械优点,有效地将施加到线的拉力减半同时使在导管中的线的远端以两倍于线接合器在板中移动的速度移动。在替代实施例中,线能够在万向节板中的线接合器220处终止而没有任何机械优点,这能够避免使线弯折。
手柄200包括中心轴230,中心轴230具有联接到壳体210的远端232、穿过万向节板218中的开口219且穿过凸轮构件234的中间部分和固定地联接到近侧弯曲旋钮240的近侧部分。远端232通过允许轴230和旋钮240相对于壳体和万向节机构旋转但阻止轴230和旋钮240相对于壳体和万向节机构纵向移动的转动轴承而被联接到壳体。尽管未示出,中心轴230和弯曲旋钮240能够包括延伸通过其整个长度的中心腔。壳体210还能够包括从轴230的远端延伸至手柄的远端212的中心腔。组合起来,手柄200的中心腔能够为通过手柄和通过附接的导管中的连接腔待进入或离开患者的其他装置和/或流体提供通路。
手柄200还包括带有指示凸块242的位置旋钮242,该指示凸块242被固定地联接到凸轮构件234并且围绕中心轴230被定位在弯曲旋钮240远侧。凸轮构件234和/或位置旋钮242能够被螺纹地或螺旋地接合到中心轴230的外表面。如图7所示,当弯曲旋钮240和中心轴230相对于位置旋钮242和凸轮构件234被旋转时(箭头1)(例如,通过保持位置旋钮相对于壳体210静止并转动弯曲旋钮),位置旋钮和凸轮构件相对于壳体和万向节机构被向远侧或向近侧驱动(箭头2),从而导致万向节板枢转(箭头3)并且改变在所有拉线上的张力。
通过使用弯曲旋钮240以向远侧或向近侧驱动凸轮构件,导管的弯曲大小被调整。凸轮的远侧移动引起万向节板更加倾斜,从而导致弯曲大小的增大,并且凸轮构件的近侧移动允许万向节板返回更靠近其垂直于手柄的纵向轴线的自然位置,从而降低导管的弯曲。参考图21的下部分,使弯曲旋钮240旋转引起导管在径向方向上弯曲,所述径向方向诸如图21中标示的四个示例性径向方向R1、R2、R3、R4。当凸轮构件处在近侧位置中时,允许万向节板处于其直立的自然位置,导管能够被放松和/或不弯曲,诸如图21中位置P1所示。当凸轮构件被向远侧驱动时,使万向节板枢转,在一侧的拉线被张紧,从而导致导管径向地弯曲,诸如弯曲至图21中标示的弯曲位置P1、P2、P3、P4中的任一个。导管弯曲的圆周角度由位置旋钮244的位置确定。
凸轮构件234的倾斜的端表面包含万向节板接触表面,所述万向节板接触表面具有斜率,该斜率根据围绕手柄的纵向轴线的圆周位置在轴向位置上变化。接触表面的斜率能够在围绕接触表面周向地移动的轴向位置中逐渐地变化,使得万向节板218随着凸轮绕手柄的纵向轴线旋转而逐渐地铰接。在一些实施例中,只有凸轮构件234的端部接触万向节板,并且凸轮构件的相同端部通过凸轮构件的旋转运动范围保持与万向节板接触,使得凸轮构件的倾斜的接触表面的精确形状不太显著。然而,在一些实施例中,接触表面能够包含围绕手柄的中心轴和/或中心腔周向地延伸的环形表面,并且接触表面能够包含任意平坦的或不平坦的轮廓,诸如限定不平行于或垂直于手柄的纵向轴线的斜面的平坦表面。
在图示说明的示例中,凸轮构件234具有大体圆柱形的径向外表面和倾斜的平坦远侧表面,从而形成与万向节板218接触的卵形的或椭圆形的远侧表面。在图示说明的示例中,凸轮构件的外表面是圆柱形的并且凸轮构件的远侧表面是平坦的,从而形成远侧表面的椭圆形周边,但是在替代实施例中凸轮构件能够包括非圆柱形的外表面和/或非平坦的远侧表面,从而导致远侧表面的非椭圆形的形状。此外,圆柱形外表面的半径和/或远侧表面的斜率能够变化以调整远侧表面的轮廓。例如,凸轮构件的远端处的较陡的或不太陡的斜坡能够为万向节板提供较大或较小的移动量,并且从而为拉线提供较大或较小的移动范围。
图10至图12图示说明用以改变导管径向弯曲处的圆周角度的位置旋钮242的旋转。位置旋钮242的旋转位置能够被凸块244或其他指示器可视化和/或可触地指示。位置旋钮242和附接的凸轮构件234能够相对于万向节机构绕中心轴旋转360度。位置旋钮的旋转位置确定凸轮构件的远侧边缘与万向节板接触的位置,并且从而确定当弯曲旋钮被用于驱动凸轮构件进入万向节板中时万向节板倾斜的方向。
万向节环216和万向节板218共同工作以允许板在任意方向上倾斜,并且因此使导管在任意方向上弯曲。在图10中,环216是静止的并且板218绕板轴线倾斜,从而拉动线A并且放松线B。这引起导管在线A的方向上弯曲。在图11中,环218绕环轴线旋转并且板216绕板轴线旋转,拉动线A和C两者,并且放松线B和D。这引起导管在线A和C之间的方向上弯曲。在图12中,板218相对于环216是静止的,并且环和板一致地绕环轴线旋转,从而拉动线C并且放松线D。这引起导管沿线C的方向上弯曲。
参考图21的下部分,位置旋钮的旋转位置能够对应于弯曲的导管在标示为C的方向上的圆周运动。例如,如果导管当前位于弯曲位置P4,则位置旋钮的90度的旋转(而弯曲旋钮相对于位置旋钮是静止的)能够将导管沿虚线移动到位置P3或位置P5(而导管不绕其中心纵向轴线旋转)。如果导管当前位于非弯曲位置P1,则位置旋钮的旋转不会引起导管的任何运动(即使是导管绕其中心纵向轴线旋转),但是能够确定当弯曲旋钮随后被旋转时导管将会弯曲的径向方向(例如,R1、R2、R3、R4)。
通过组合地调整弯曲旋钮和位置旋钮(同时地或一次一个),导管能够被操纵至图21中的虚线圆内的任意位置(假设虚线圆表示最大弯曲程度),而无需使导管绕其中心纵向轴线在患者体内旋转(导管在血管内的旋转例如能够损伤血管的内衬)。
在一些实施例中,万向节板能够具有非平坦的接触表面,该接触表面具有在万向节板上周向和/或径向地在高度上变化的(一个或多个)凸起和/或(一个或多个)凹陷。这能够补偿未使用无限数量的围绕板的周边的拉线引起的任何离散效应。例如,当凸轮构件推动两个线之间的万向节板时,可能需要在拉线上的少量额外拉力以便于获得在导管的远端处的相同量的弯曲。这些凸起或凹陷能够通过在某些周向和径向凸轮接触位置处使板稍微更多或更少地倾斜来实现该额外拉力。例如,如果使用了完全平坦的万向节板,则当位置旋钮使弯曲方向在其中两个拉线之间时,可以发生轻微的非弯曲。在拉线接合器之间的位置中在万向节板上包括平缓凸起(仅作为一个例子)能够通过当凸轮接触凸起时使万向节板稍微更多地倾斜来补偿预期的非弯曲,从而提供在两个拉线之间的方向上保持恒定弯曲大小所需要的额外拉线运动。
图13至图19图示说明另一示例性控制手柄300,其包括与万向节机构相接的凸轮构件以控制在若干不同拉线上的张力。控制手柄300以与控制手柄200相似的方式起作用,其中主要的区别是导管被连接到手柄的相反纵向末端并且拉线两次返回并从手柄的相反纵向末段向外延伸,与手柄200相比对换了远侧方向和近侧方向。
手柄300包含形成近端314的壳体310,并且手柄具有位于弯曲旋钮322处或靠近弯曲旋钮322的远端312。弯曲旋钮322相对于中心轴320被轴向地固定,并且位置旋钮324以螺纹啮合或螺旋相接被定位成围绕弯曲旋钮和/或在弯曲旋钮内,使得弯曲旋钮的旋转相对壳体内部的万向节机构轴向地驱动位置旋钮和附着的凸轮构件326。像手柄200一样,该万向节机构包括绕环轴线被可枢转地安装在壳体内部的万向节环316和沿垂直于环轴线的板轴线经由枢轴被可枢转地安装在环内部的万向节板318。手柄300还包括安装在壳体310内部靠近万向节机构的线导向板330。
手柄300中的每个拉线具有固定到线导向板330的自由末端340、从自由末端340向远侧延伸至万向板318并且围绕万向板中的滑轮或其他导向器342的第一部分、从万向板向后近侧延伸至线导向板330中的第二滑轮或导向器334然后围绕滑轮或导向器344延伸至第三部分的第二部分,其中第三部分沿手柄的长度向远侧延伸通过中心轴320并且穿过手柄的远端312延伸出进入联接到手柄的导管。
图15图示说明旋转弯曲旋钮322(箭头1)如何引起凸轮构件326轴向地移动(箭头2)并且引起凸轮构件的远侧边缘以使万向节板318和/或环316倾斜(箭头3),这样调整附接的导管的弯曲大小。
图16示出当凸轮构件不使万向节环316和板318倾斜时万向节环316和板318处于放松位置的手柄300。在这种状态中,附接的导管能够位于放松、非弯曲的中性位置。图17示出凸轮326向近侧被推进,使万向节板316倾斜而万向节环316保持静止。这引起附接的导管在选定的径向方向上的弯曲。图18示出凸轮构件326已经从图17旋转几度,使得万向节板和环两者都被枢转。这引起附接的导管与图17相比弯曲大约相同的大小但是在对应的不同径向方向上弯曲。在图19中,凸轮构件从图17旋转大约90度,使得万向节环相对于壳体310被枢转,但是万向节板不相对于万向节环被枢转。在该位置中,附接的导管弯曲与图17和18中一样被弯曲大约相同的径向量,但是其是在距对应于图17的位置的方向大约90度的方向上被弯曲。
随着万向节板318相对于线导向板330移动,拉线围绕在两个板中的线导向器342和344铰接,从而提供以下机械优点:放大了凸轮构件和万向节板的相对小的运动以提供导管的期望弯曲。像手柄200一样,将旋钮322和324联接到拉线的机械系统能够被配置和/或校准以在精细控制和导管弯曲的移动范围之间提供期望的平衡。万向节机构还提供导管弯曲的模拟的、全360度的调整范围,而无需在患者体内旋转导管。
图20是图示说明用于将万向节机构联接到拉线而不使拉线成环或卷曲的替代手柄系统400的示意图。系统400包括:壳体410,其带有安装到壳体内部的万向节环412和万向节板414;以固定关系安装到壳体的固定齿条齿轮416;与每个固定齿条齿轮416相对并且联接到拉线424的移动齿条齿轮422;啮合于固定齿条齿轮和移动齿条齿轮之间的滚动小齿轮418;和从万向节板414联接至每个小齿轮418的中心的刚性连接器构件420。凸轮构件(未示出)引起万向节机构的移动,所述移动拉动和推动刚性连接器构件420,从而引起小齿轮418沿固定齿条齿轮416相应地滚动。对于小齿轮418滚动的每个距离单元,移动齿条齿轮422在相同的方向上移动但移动两倍远,从而产生将凸轮构件的移动放大成为拉线的更显著移动的机械优点,但是不使用滑轮或其他装置,所述滑轮或其他装置需要使拉线围绕锋利的角度被卷曲或弯折,这样会随时间的推移使线损坏。
应当理解,所公开的实施例能够适于将假体装置输送和植入到心脏的任何天然瓣环(例如,肺动脉瓣环、二尖瓣环和三尖瓣环)中,并且能够与各种方法(例如,逆行、顺行、经中隔、经心室、经心房等)中的任意种一起使用。公开的实施例还能够用于将假体植入身体的其他腔中。此外,除了人工瓣膜之外,本文描述的输送组件实施例能够适用于输送和植入各种其他假体装置,例如支架和/或其他假体修复装置。在另一些实施例中,公开的装置能够用于执行除植入假体装置之外的各种其他经血管外科手术。
出于本说明书的目的,本文描述了本公开的实施例的某些方面、优点和新颖特征。所公开的方法、装置和系统不应被解释为以任何方式进行限制。相反,本公开内容针对各种公开的实施例单独的并且彼此的各种组合和子组合的所有新颖和非显而易见的特征和方面。所述方法、装置和系统不限于任何特定方面或特征或其组合,所公开的实施例也不要求存在任何一个或多个特定优点或待解决的问题。
尽管为了方便呈现,以特定的顺序次序描述了一些公开的实施例的操作,但是应该理解,这种描述方式包括重新排列,除非下面阐述的特定语言需要特定的排序。例如,顺序描述的操作在某些情况下可以被重新排列或同时执行。此外,为了简单起见,附图可能未示出所公开的方法能够与其他方法结合使用的各种方式。另外,描述中有时使用像“提供”或“实现”之类的术语来描述所公开的方法。这些术语是执行的实际操作的高级抽象。对应于这些术语的实际操作可以根据具体实施方式而变化,并且本领域普通技术人员容易地辨别。
如在本申请和权利要求中所使用的,除非上下文另有明确规定,单数形式“一”,“一个”和“该”包括复数形式。另外,术语“包括”意思是“包含”。此外,术语“联接”通常表示物理地、电气地、磁性地和/或化学地联接或链接,并且不排除在没有特定相反语言的联接或关联项目之间存在中间元素。
如本文所使用的,术语“近侧”是指设备的位置、方向或部分更靠近设备的使用者/操作者并且更远离设备在患者体内的末端或终点(例如,心脏)。如本文所用,术语“远侧”是指设备的位置、方向或部分更远离设备的使用者/操作者并且更靠近设备在患者体内的末端或终点。因此,例如,导管的近侧移动是导管离开身体和/或朝向操作者的移动(例如,导管从患者体内缩回),而导管的远侧移动是导管远离操作者并且进一步进入身体的移动(例如,将导管朝向心脏插入身体)。除非另有明确定义,术语“纵向”和“轴向”是指在近侧方向和远侧方向上延伸的轴线。
如本文所用,术语“一体形成”和“整体构造”是指一件式构造,其不包括任何焊接、紧固件或用于将单独形成的材料件彼此固定的其他手段。
如本文所使用的,虽然“同时”或“同时地”发生的操作通常彼此同时发生,但是在没有特定的相反语言的情况下由于位于诸如螺纹、齿轮等的机械联动装置中的部件之间的间隔、游隙或间隙所引起的一个操作相对于另一个操作的发生的延迟明确地在上述术语的范围内。
鉴于可以应用本公开的原理的许多可能的实施例,应该认识到,所示实施例仅是优选示例,并且不应被视为限制本公开的范围。相反,所公开技术的范围至少与随附的权利要求一样宽。因此,我们要求将所有这些发明内容都落在这些权利要求及其等同物的范围内。
Claims (32)
1.一种用于可操纵导管的控制手柄,所述手柄包含:
壳体,所述壳体限定在远侧方向和近侧方向上延伸的纵向轴线,以及拉线,所述拉线向远侧延伸离开所述手柄并且进入可操纵导管;
所述控制手柄的特征在于:
凸轮构件,所述凸轮构件相对于所述壳体可轴向移动并且还相对于所述壳体绕所述纵向轴线可旋转地移动;和
至少一个从动件,所述至少一个从动件与所述凸轮构件接合,使得所述至少一个从动件响应于所述凸轮构件相对于所述壳体的移动而相对于所述手柄移动;
其中所述拉线被联接到所述至少一个从动件以基于所述至少一个从动件相对于所述壳体的位置实现所述可操纵导管的弯曲。
2.根据权利要求1所述的手柄,其还包含弯曲旋钮,所述弯曲旋钮的旋转引起所述凸轮构件的轴向调整。
3.根据权利要求2所述的手柄,其中所述弯曲旋钮相对于所述手柄的中心轴被固定,所述中心轴轴向地延伸通过所述凸轮构件并且与所述壳体可旋转地接合,以允许所述弯曲旋钮和所述中心轴相对于所述壳体的旋转并限制所述弯曲旋钮和所述中心轴相对于所述壳体的轴向移动。
4.根据权利要求3所述的手柄,其中所述中心轴与所述凸轮构件接合,使得所述弯曲旋钮相对于所述壳体的旋转引起所述凸轮构件相对于所述壳体的轴向移动。
5.根据权利要求2-4中的任一项所述的手柄,其还包含相对于所述凸轮构件固定的位置旋钮,其中所述位置旋钮的旋转引起所述凸轮构件的旋转调整。
6.根据权利要求5所述的手柄,其中所述位置旋钮和所述弯曲旋钮被定位成邻近所述手柄的远端。
7.根据权利要求5所述的手柄,其中所述位置旋钮和所述弯曲旋钮被定位成邻近所述手柄的近端。
8.根据权利要求1-4中的任一项所述的手柄,其中所述凸轮构件包含在一个轴向端部处的与所述至少一个从动件相接的接触表面,所述接触表面具有斜率,所述斜率根据围绕所述手柄的所述纵向轴线的圆周位置在轴向位置上变化。
9.根据权利要求8所述的手柄,其中所述凸轮构件的所述接触表面的所述斜率在围绕所述接触表面周向地移动的轴向位置上逐渐地变化,使得所述至少一个从动件随着所述凸轮构件绕所述手柄的所述纵向轴线旋转而逐渐轴向地移动。
10.根据权利要求8所述的手柄,其中所述凸轮构件的所述接触表面包含围绕所述手柄的中心轴周向地延伸的环形表面。
11.根据权利要求9-10中的任一项所述的手柄,其中所述凸轮构件的所述接触表面是平坦表面,所述平坦表面限定不平行于或垂直于所述手柄的所述纵向轴线的斜面。
12.根据权利要求1-4中的任一项所述的手柄,其中所述至少一个从动件包含多个可独立移动的滑动件,所述多个可独立移动的滑动件中的每个可独立移动的滑动件均被联接到所述拉线中的相应一个拉线。
13.根据权利要求12所述的手柄,其中所述滑动件被限制为只相对于所述壳体轴向地移动。
14.根据权利要求12所述的手柄,其中所述凸轮构件相对于所述壳体的旋转引起所述滑动件中的一个或多个滑动件相对于所述壳体向近侧移动并且还同时引起所述滑动件中的一个或多个滑动件相对于所述壳体向远侧移动。
15.根据权利要求12所述的手柄,其中所述凸轮构件的轴向移动引起所有所述滑动件在相同的轴向方向上移动。
16.根据权利要求1-4中的任一项所述的手柄,其中所述至少一个从动件向所述凸轮构件偏置,使得当所述凸轮构件移动远离所述至少一个从动件时所述至少一个从动件保持与所述凸轮构件接触。
17.根据权利要求1-4中的任一项所述的手柄,其中所述至少一个从动件包含万向节机构。
18.根据权利要求17所述的手柄,其中所述万向节机构包含万向节环和万向节板。
19.根据权利要求18所述的手柄,其中所述万向节环被可枢转地联接在所述壳体内并且所述万向节板被可枢转地联接在所述万向节环内。
20.根据权利要求18或权利要求19所述的手柄,其中所述拉线被联接到所述万向节板。
21.根据权利要求18-19中的任一项所述的手柄,其中所述凸轮构件与所述万向节板接触。
22.根据权利要求21所述的手柄,其中所述万向节板在所述凸轮构件接触所述万向节板的位置包含一个或多个凸起或凹陷,使得当所述凸轮构件接触所述一个或多个凸起或凹陷时所述凸轮构件相对于所述万向节板的轴向位置被轻微地调整。
23.根据权利要求18-19中的任一项所述的手柄,其中所述凸轮构件的所述位置确定所述万向节机构的取向,并且所述万向节机构的所述取向确定所述拉线的轴向位置。
24.根据权利要求18-19中的任一项所述的手柄,其中所述拉线围绕所述万向节机构中的线导向器形成环。
25.根据权利要求18-19中的任一项所述的手柄,其中所述拉线围绕线导向器形成环,所述线导向器相对于所述壳体在所述万向节机构的近侧被固定。
26.根据权利要求1-4中的任一项所述的手柄,其中所述至少一个从动件包含球窝机构,其中所述凸轮构件接触所述球窝机构中的窝部分。
27.根据权利要求1-4中的任一项所述的手柄,其还包含齿条齿轮机构,所述齿条齿轮机构将运动从所述至少一个从动件传递到所述拉线中的至少一个。
28.根据权利要求1-4中的任一项所述的手柄,其还包含离合机构,所述离合机构被配置为选择性地固定所述凸轮构件的轴向位置和周向位置中的一个,同时允许所述凸轮构件的所述轴向位置和所述周向位置中的另一个运动。
29.根据权利要求1-4中的任一项所述的手柄,其中所述手柄能够允许使用者独立地调整附接的导管的径向弯曲的大小和调整所述径向弯曲指向的圆周角度。
30.根据权利要求29所述的手柄,其中附接的导管的所述径向弯曲的大小和所述径向弯曲指向的所述圆周角度能够使用所述手柄被调整而无需使所述导管绕其纵向轴线旋转。
31.一种用于操纵导管的方法,其包含使用权利要求1-30中的任一项所述的手柄通过相对于所述壳体轴向地和/或周向地移动所述凸轮构件来操纵联接到所述手柄的所述导管,引起所述至少一个从动件相对于所述壳体移动并且调整所述拉线中的张力,并且从而基于所述至少一个从动件相对于所述壳体的位置引起所述导管的所述弯曲的变化。
32.一种用于操纵导管的组件,所述组件包含权利要求1所述的手柄,所述手柄被联接到所述导管,其中所述拉线沿着所述导管的轴向长度延伸并且所述手柄可操作以调整所述导管的径向弯曲的大小和调整所述径向弯曲指向的圆周角度。
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