CN109310501A - 用于治疗血管功能不全的装置和方法 - Google Patents
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Abstract
公开了小叶夹具装置和减少通过天然心脏瓣膜的反流的方法的实施例。小叶夹具装置能够包括具有第一端部部分和第二端部部分的伸长的夹持构件和联接到夹持构件的张紧机构。小叶夹具装置能够进一步包括设置在夹持构件的管腔内的一个或更多个张紧构件,其中一个或更多个张紧构件可操作地连接到张紧机构,以将夹持构件从递送构型变换成植入构型。
Description
技术领域
本公开涉及治疗心脏瓣膜功能不全的装置和方法。
背景技术
心脏瓣膜功能不全通常包括通过不能完全或正确闭合的心脏瓣膜的血液反流,从而导致心血管功能受损。瓣膜功能不全能够影响例如二尖瓣、主动脉瓣或三尖瓣,并且能够与钙化或脱垂的小叶,和/或瓣环的膨胀或变形相关联。治疗心脏瓣膜功能不全的一种方法是采用一个或更多个小叶夹具来改善天然瓣膜小叶的对合。然而,常规的小叶夹具会难以植入,能够干扰或损坏相关瓣膜结构诸如腱索的功能,并且经常被限于和单一类型的心脏瓣膜一起使用。因此,可期望对治疗心脏瓣膜功能不全的装置和方法的改善。
发明内容
小叶夹具装置的示例性实施例能够包括具有第一端部部分和第二端部部分的伸长的夹持构件以及联接到夹持构件的张紧机构。小叶夹具装置能够进一步包括设置在夹持构件的管腔内的一个或更多个张紧构件,其中一个或更多个张紧构件可操作地连接到张紧机构,以将夹持构件从递送构型变换成植入构型。夹具装置的一些实施例可以进一步包括设置在夹持构件的管腔内的保持机构,其中保持机构保持处于植入构型中的夹持构件的形状。
在夹具装置的一些实施例中,夹持构件能够损害形状记忆材料。另外和/或替代地,张紧机构能够相对于第一端部和第二端部在中心联接到夹持构件。在一些实施例中,一个或更多个张紧构件能够包括第一张紧构件以及第二张紧构件,第一张紧构件在其远侧端部部分处固定到夹持构件的第一端部部分,并且在第一张紧构件的近侧端部部分处可操作地连接到张紧机构,第二张紧构件在其远侧端部部分处固定到夹持构件的第二端部部分,并且在第二张紧构件的近侧端部部分处可操作地连接到张紧机构。在夹具装置的一些实施例中,张紧机构的至少一部分的旋转能够使一个或更多个张紧构件张紧。
在夹具装置的一些实施例中,植入构型能够包括在夹持构件的两个腿部部分之间限定的主要夹持区域。另外地和/或替代地,张紧机构能够包括被配置为将夹持构件保持在植入构型中的保持机构。另外地和/或替代地,一个或更多个张紧构件能够延伸穿过张紧机构的一部分。另外地和/或替代地,一个或更多个张紧构件在一个端部处固定到张紧机构的一部分。
另外地和/或替代地,示例性小叶夹具装置能够包括:夹持构件,其包括具有管腔的管状主体和两个腿部部分,其中夹持构件能够在基本上线性的递送构型和植入构型之间变换,在植入构型中,腿部部分被拉向彼此以在腿部部分之间捕获一对小叶;以及张紧机构,其被配置为将夹持构件从递送构型变换成植入构型。另外地和/或替代地,夹具装置能够进一步包括设置在夹持构件的管腔内的一根或更多根绳线,其中一根或更多根绳线可操作地连接到张紧机构,以将夹持构件从递送构型变换成植入构型。另外地和/或替代地,张紧机构的至少一部分的旋转能够使一根或更多根绳线张紧,这导致夹持构件从递送构型变换成植入构型。
在夹具装置的一些实施例中,张紧机构能够包括螺钉和螺母,一根或更多根绳线连接到螺母,使得螺钉的旋转使螺母沿螺钉轴向地移动并且向一根或更多根绳线施加张力。在一些实施例中,小叶夹具装置能够进一步包括设置在夹持构件的管腔内的保持机构,其中保持机构将夹持构件保持在植入构型中。
另外地和/或替代地,管状主体能够包括金属管,金属管具有沿管状主体的长度轴向间隔开的周向狭槽。另外地和/或替代地,在植入构型中,夹持构件能够具有希腊字母Ω的形状。另外地和/或替代地,当夹持构件处于植入构型时,腿部部分能够从管状主体的中间部分的相应端部朝向彼此延伸,以限定用于捕获一对小叶的夹持区域,其中腿部部分在远离夹持区域的方向上彼此远离地延伸。
减少通过天然心脏瓣膜的反流的示例性方法能够包括将小叶夹具装置定位在与心脏瓣膜的两个相邻小叶的对合边缘相邻的位置处,其中小叶夹具装置包括夹持构件和设置在夹持构件的管腔内的第一张紧构件和第二张紧构件,第一张紧构件固定到夹持构件的第一端部部分,并且第二张紧构件固定到夹持构件的第二端部部分;以及向张紧构件施加张力,以将夹持构件从递送构型变换成植入构型,在植入构型中小叶的对合边缘被捕获在夹持构件的两个腿部部分之间。
另外地和/或替代地,施加张力能够包括旋转可操作地联接到第一张紧构件和第二张紧构件的张紧机构。在一些实施例中,该方法能够包括接合保持机构以将夹持构件保持在植入构型中。另外地和/或替代地,在递送构型中,夹持构件能够具有基本上线性的形状。
从以下参照附图进行的详细描述,本发明的前述和其他目的、特征和优点将变得更加显而易见。
附图说明
图1是小叶夹具装置的代表性实施例的透视图,其中出于说明目的将张紧机构的一部分脱离。
图2是示出出于说明目的而部分脱离的图1的夹具装置的夹持构件的放大部分。
图3是示出出于说明目的而部分脱离的图1的小叶夹具装置的放大部分。
图4是小叶夹具装置的另一代表性实施例的透视图,该小叶夹具装置具有用于接合多对小叶的多个整体夹持构件。
图5是小叶夹具装置的另一代表性实施例的前正视图。
图6是植入天然主动脉瓣中的小叶夹具装置的代表性实施例的透视图。
图7是递送设备和装载在递送设备中用于递送到患者体内的小叶夹具装置的侧视图。
图8是小叶夹具装置的另一代表性实施例的前正视图。
图9是小叶夹具装置的另一代表性实施例的前正视图。
图10是图9所示的小叶夹具装置的螺钉的前正视图。
图11是小叶夹具装置的另一代表性实施例的前正视图。
图12是小叶夹具装置的另一代表性实施例的前正视图。
图13是根据一个实施例的由激光切割金属管形成的夹持构件的前视图。
图14示出用于激光切割金属管以形成诸如图13所示的夹持构件的切割图案。
图15是图14所示的切割图案的一部分的放大视图。
图16是根据另一实施例的由激光切割金属管形成的夹持构件的前视图。
图17是用于激光切割金属管以形成诸如图16所示的夹持构件的切割图案的一部分的放大视图。
具体实施方式
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、设备和系统不应被解释为以任何方式加以限制。相反,本公开涉及各种公开的实施例的所有新颖且非显而易见的特征和方面,这些特征和方面是单独地和彼此呈不同的组合和子组合。方法、设备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更多个特定优点或解决问题。
结合具体方面、实施例或示例描述的特征、整体、特性、化合物、化学根或基团应被理解为适用于本文所述的任何其他方面、实施例或示例,除非与其不相容。本说明书(包括任何所附权利要求、摘要和附图)中公开的所有特征,和/或如此公开的任何方法或过程的所有步骤可以以任何组合结合,除了其中此类特征和/或步骤中的至少一些是相互排斥的组合。本发明不限于任何公开的实施例的细节。本发明延伸到本说明书(包括任何所附权利要求、摘要和附图)中公开的任何新颖的特征或特征的任何新颖的组合,或如此公开的任何方法或过程的步骤的任何新颖的内容或任何新颖的组合。
虽然为了便于呈现,以具体的顺序次序描述了所公开的方法中的一些的操作,但是应当理解,这种描述方式包括重新排列,除非下文所述的特定语言需要具体的排序。例如,在一些情况下,顺序地描述的操作可以重新排列或同时执行。此外,为了简单起见,附图不能显示所公开的方法可以结合其他方法使用的各种方式。另外,本说明书有时使用像“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而改变,并且本领域普通技术人员可容易识别。
如在本申请和权利要求中所使用的,单数形式“一”、“一个”和“该”包括复数形式,除非上下文另有明确规定。另外,术语“包括”是指“包含”。进一步地,在未使用特定的相反语言的情况下,术语“联接”和“相关联”通常是指电力地、电磁地和/或物理地(例如,机械地或化学地)联接或连接,并且不排除在联接的或相关联的项目之间的中间存在元件。
如本文所使用的,术语“近侧”是指装置的更靠近使用者并且进一步远离植入部位的位置、方向或部分。如本文所使用的,术语“远侧”是指装置的进一步远离使用者并且更靠近植入部位的位置、方向或部分。因此,例如,装置的近侧运动是装置朝向使用者的运动,而装置的远侧运动是装置远离使用者的运动。术语“纵向”和“轴向”是指轴线在近侧方向和远侧方向上延伸,除非另有清楚地定义。
如本文所使用的,术语“整体形成”和“一体结构”是指不包括用于将单独形成的材料块彼此固定的任何焊缝、紧固件或其他装置的构造。
图1示出小叶夹具装置10的代表性实施例。所示实施例中的夹具装置10包括伸长的夹持构件12和张紧机构14。夹持构件12能够包括伸长的大致管状或圆柱形的主体,该主体具有第一端部部分16、第二端部部分18、从第一端部部分16延伸到第二端部部分18的管腔20。张紧机构14能够包括设置在夹持构件12的管腔20内的一根或更多根绳线或张紧构件22。如本文所使用的,术语“张紧构件”或“绳线”是指能够由单根金属丝、线、纤维或细丝形成的,或者能够包括多根金属丝、线、纤维或细丝的细长材料。
夹持构件12能够从递送构型变换为植入构型,反之亦然。在递送构型中,夹持构件12能够处于基本上纵向延伸或拉直的构型(参见图7)。在植入构型(参见图1)中,夹持构件12的两个部分被拉向彼此,从而形成主要夹持区域24,使得一个或更多个天然瓣膜小叶的一部分能够在主要夹持区域内被捕获或压紧在夹持构件的两个部分之间(参见图6)。
在植入构型中,所示实施例中的夹持构件12具有类似于希腊字母“Ω”的形状。具体地,夹持构件12能够具有中间部分26(其能够如图所示线性地延伸或者能够被弯曲)以及第一腿部部分28和第二腿部部分30,第一腿部部分28和第二腿部部分30分别朝向彼此延伸,从而在沿远离中间部分26的相应端部延伸的方向上移动,以形成夹持区域24。然后,腿部部分28、30彼此远离延伸,从而在远离夹持区域24延伸的方向上移动。用于夹持构件12的其他递送构型也是可能的。例如,在递送构型中,夹持构件12能够折叠一半,使得第一腿部部分28和第二腿部部分30被拉直并且相对于彼此平行且边对边地延伸。
本文所述的小叶夹具装置10和任何其他小叶夹具实施例能够用于通过重塑心脏瓣膜的环和/或小叶来治疗瓣膜功能不全或反流。例如,图6示出位于天然主动脉瓣200中的小叶夹具装置10。天然主动脉瓣200能够包括附接到瓣环216的三个瓣膜小叶210、212、214。瓣膜小叶210和212能够形成第一连合部218,小叶212和214能够形成第二连合部220,并且小叶210和214能够形成第三连合部222。
所示小叶夹具装置10位于邻近第一连合部218的位置处,使得小叶夹具装置10接合小叶210和212。所示小叶夹具装置10还位于瓣环216的壁附近。以这种方式,小叶夹具10能够改善小叶210、212在连合部218处的对合,从而减少由于瓣膜功能不全而导致的通过瓣膜200的反流。另外,虽然所示小叶夹具10夹持到邻近瓣环216的相应小叶,但是小叶夹具10能够根据需要在沿小叶的任何合适的位置处包括在天然瓣膜的中心处夹持到小叶。
虽然示出一个夹具装置10被植入天然主动脉瓣中,但是能够植入多个小叶夹具10以减小瓣环216的扩张和/或解决瓣环216的形状异常。例如,能够在每对小叶上例如在每个连合部218、220、222处植入小叶夹具10。替代地或另外地,能够沿一对相邻小叶的对合边缘植入多个夹具装置10。例如,能够沿小叶210、212的对合边缘植入多个夹具装置10。
再次参考图1,张紧机构14能够经由张紧构件22可操作地联接到夹持构件12,张紧构件22将张力施加到夹持构件12,以将夹持构件12从递送构型变换成植入构型并且/或者在从递送构型部分展开之后,使腿部部分28、30一起更加靠近最终的植入构型,如下面进一步描述的。
在小叶夹具装置10的具体实施例中,夹持构件12能够由金属管形成(例如,激光切割),如图13和图16所示。管能够沿管的长度形成有多个狭槽或切口,以促进管从递送构型弯曲成植入构型。
在一些实施例中,夹持构件12能够由非线性的弹性的、超弹性的和/或形状记忆材料诸如镍钛诺形成,并且在植入构型中被设定形状。夹持构件12能够在将装置递送在患者体内期间保持在递送构型中(例如使用递送设备的护套),并且当从递送构型释放时,夹持构件12自动地朝向植入构型返回。在一些实施例中,夹持构件12能够在其自身的弹性下自动地从递送构型自行展开到部分展开的构型,使得腿部部分28、30在夹持区域24处彼此间隔开。然后,张紧机构14能够用于使用足够的力拉动腿部部分28、30一起更靠近图1所示的植入构型,以将其自身接合并锚固在一对天然瓣膜小叶上。在其他实施例中,夹持构件的形状能够设定成基本上直线或线性的递送构型,并且张紧机构14用于使夹持构件从递送构型变形或弯曲成植入构型。
在替代实施例中,夹具装置10不具有张紧机构14,并且夹持构件12的形状记忆材料使得夹持构件12在其自身的弹性下从递送构型变换为植入构型,并且提供抵靠天然小叶的足够的力,以将夹持构件12锚固在一对天然小叶上,而无需单独的张紧机构。
在其他实施例中,夹持构件12能够由线性弹性材料诸如不锈钢或钴铬合金形成。在此类实施例中,张紧机构14能够用于将夹持构件12从递送构型变换或变形到植入构型。线性弹性金属诸如不锈钢或钴铬合金也在施加的力超过预定阈值之后塑性变形。在一些实施例中,张紧机构14能够用于在夹持构件12从递送构型变形到植入构型时使夹持构件12塑性变形。
图13示出由激光切割金属管形成的夹持构件12的示例。图14示出用于形成图13所示的夹持构件12的金属管的示例性切割图案。图15是图14所示的切割图案的一部分的放大视图。虽然没有示出,但是夹持构件能够包括遍布并覆盖金属管的外表面的覆盖物。覆盖物能够包括合适的织物(例如,聚对苯二甲酸乙二醇酯(PET)织物)、非织物聚合材料(例如,聚氨酯或硅树脂)或天然组织(例如,心包膜组织)。
如图14和图15所示,能够在选定位置处在夹持构件12中形成一系列轴向间隔开的周向切口。沿腿部部分28、30,切口形成一系列周向间隙80,其中突起82和凹口84在间隙80的中心部分的相对侧上。在所示实施例中,夹持构件12没有或基本上没有朝向植入构型的形状记忆,并且在图13中示出被变换成植入构型之前处于其自然静止状态的夹持构件12。在该示例中的夹持构件能够包括例如不锈钢或钴铬合金金属管。如下面进一步描述的,通过向夹持构件12施加力,夹持构件能够从基本上直线或线性构型变换成图1所示的植入构型。间隙80在夹持构件弯曲成植入构型时促进夹持构件的弯曲。突起82能够停留在对应的凹口84中,以阻止夹持构件在其变换成植入构型时的不期望的扭转。
图16示出由激光切割金属管形成的夹持构件12的另一示例。除了周向切口形式的配合特征之外,图16的夹持构件12能够与图13的夹持构件基本相同,周向切口形式的配合特征有助于在夹持构件变换成植入构型时维持夹持构件的形状。具体地,如图17所示,切口形成一系列周向间隙86,其中突起88和凹口90在间隙86的中心部分的相对侧上。突起88具有非线性相对边缘92,当夹持构件朝向植入构型弯曲时,边缘92能够接合凹口90的类似成形的非线性边缘94。突起88的边缘92能够摩擦地接合凹口90的边缘94,以阻止夹持构件朝向递送构型返回拉直。图16示出在不对夹持构件施加其他力的情况下,通过切口的保持特征保持在部分展开状态中的夹持构件。在一些实施例中,切口的保持特征能够被配置为将夹持构件的形状保持在图1所示的植入构型中。
当夹持构件12处于植入构型时,能够确定小叶夹具装置的夹持强度。如本文所使用的,术语“夹具保持力”和“夹紧强度”是指近侧方向上能够由小叶夹具装置在夹持构件处于植入构型时不脱离心脏瓣膜的小叶的情况下所承受的力。在一些实施例中,夹具装置和/或用于夹具装置的递送设备能够包括可操作以测量小叶夹具装置10的保持力的应变仪或等效装置。
张紧机构14能够被配置为允许小叶夹具装置到植入构型的细微关闭运动。在具体实施例中,夹具保持力能够经由张紧机构14受到完全控制。例如,在图1和图3所示的实施例中,张紧机构14能够包括螺钉32和可移动元件诸如螺母34,螺母34可螺纹地与螺钉32接合并且可沿螺钉32的长度移动。张紧机构14能够进一步包括容纳螺钉32和螺母34的壳体54,以及在螺母34的相对侧上的两个板或条56。板56接触螺母34的相邻表面,并且防止在螺钉32旋转时螺母34的旋转。因此,螺钉32的旋转产生螺母34在壳体54内沿螺钉的长度的轴向运动。
螺钉32能够具有近侧端部部分58,近侧端部部分58能够被可释放地连接到递送设备或能够被操纵以旋转螺钉32的另一工具。例如,递送设备或另一工具的旋转轴能够具有可释放地连接到螺钉32的近侧端部部分58的远侧端部部分。轴的近侧端部部分能够由使用者(手动地或通过启动使轴旋转的马达)旋转,这继而使得螺钉32旋转。
第一绳线22a能够具有附接到夹持构件12的第一端部部分16的远侧端部部分36,并且第二绳线22b能够具有附接到夹持构件12的第二端部部分18的远侧端部部分38。绳线22a、22b的远侧端部部分36、38能够诸如通过将远侧端部部分36、38焊接到夹持构件12的管腔表面而被固定地固定到夹持构件12的部分。第一和第二绳线22a、22b的近侧端部部分40、42能够例如通过将近侧端部部分40、42放置在螺母34中的相应孔60中并将其焊接到位而被固定地固定到螺母34。如箭头62所示,通过使螺母34沿螺钉32的长度在近侧方向上远离夹持构件12移动,能够将张力施加到第一和第二绳线22a、22b。如箭头64所示,能够通过使螺母34在远侧方向上朝向夹持构件12移动来释放或减轻在第一和第二绳线22a、22b上的张力。
绳线22a、22b的张紧有效地向腿部部分28、30施加压缩或弯曲力,这使得腿部部分在夹持区域24处弯曲并且/或者使得腿部部分被一起拉到更靠近夹持区域处,并且沿小叶的对合边缘抵靠天然小叶施加足够的保持力。绳线22a、22b的进一步张紧能够允许对夹持构件的中间部分26进行操纵,以执行对天然瓣膜尖区域的再成形。如上所述,夹持构件12能够包括在沿夹持构件12的期望夹持构件12弯曲的预定位置处的屈曲切口和/或管材料的打薄,例如在弯曲部44、66处的打薄或屈曲切口44。屈曲切口的材料去除的长度、定位、频率和数量能够允许多种选择以便以限定的顺序、位置、分辨率和限定的曲率在特定区域产生屈曲。
小叶夹具装置10的细微关闭运动能够取决于螺钉32的螺纹螺距。例如,相对较小的螺距将增加对腿部部分28、30之间在夹持区域24处的间隔的控制量和施加到一对天然小叶的保持力。
代替或除锁定屈曲切口(如图17所示)之外,小叶夹具装置10的一些实施例能够包括一个或更多个保持特征,以有助于将夹持构件12保持在其植入构型中。例如,夹持构件12能够包括在每个弯曲部44处的保持机构46,一旦达到夹持构件12中的预定的弯曲角度,保持机构46就将夹持构件的该部分保持在其变形状态中。如图2所示,每个锁定机构46能够在弯曲部44处设置在夹持构件12的管腔内。每个锁定机构46能够包括至少第一锁定构件48和第二锁定构件50,第一锁定构件48和第二锁定构件50被配置为当夹持构件从递送构型变换成植入构型时相对于彼此移动。锁定构件48、50能够具有相对边缘,相对边缘具有在植入构型中抵靠彼此嵌套的互补形状。例如,第一锁定构件48能够具有接收第二锁定构件50的突出部70的凹口68。
当夹持构件12在递送构型中基本上拉直时,锁定构件48、50相对于彼此放置在重叠位置中,并且当夹持构件12朝向植入构型移动时能够抵靠彼此滑动。当弯曲部44达到预定的曲率时,例如当达到植入构型时,突出部70移动成接合在凹口68内,如图2所示。锁定构件48、50能够抵靠彼此横向偏压以迫使突出部70接合凹口68。锁定构件48、50的接合阻止夹持构件在弯曲部44处进一步弯曲超出植入构型,并且阻止夹持构件在弯曲部44处弯曲回到递送构型。保持构件46能够减小放置在绳线22a、22b上的负载,并且能够增强夹具装置维持小叶上的一致的保持力达较长时段的能力。
另外地和/或替代地,张紧机构14还能够包括用于将夹持构件12保持在植入构型中的保持或锁定机构。例如,由于一根或更多根绳线22中的张力与螺钉32和螺母34之间的摩擦力的平衡,张紧机构14能够将夹持构件保持在植入构型中。以这种方式,螺钉32和螺母34用作保持机构。另外地和/或替代地,可变螺距螺钉能够提供保持机构,由此螺母34能够沿螺钉的具有第一螺距的第一部分行进,并且然后锁定到螺钉的具有不同于第一螺距的第二螺距的第二部分上或与其形成机械干涉,如下面结合图9至图10进一步描述的。
图7示出根据一个实施例的用于在患者体内经皮递送和植入夹具装置10的递送设备400的远侧端部部分。递送设备能够包括外护套402、延伸穿过护套402的第一轴404和延伸穿过第一轴404的第二轴406。护套402具有尺寸被设定成将夹具装置10接收并保持在递送构型中的管腔,用于通过病人的身体进行递送。内轴404能够被可释放地连接到夹具装置上的方便位置,如图所示的张紧机构14。轴404能够用于操纵或调节夹具装置10相对于护套402的位置和植入位置。例如,轴404能够用于从护套402展开夹具装置10,相对于植入位置向远侧和向近侧移动夹具装置,和/或相对于植入位置旋转夹具装置。第二轴406能够被可释放地联接到张紧机构14的螺钉32的近侧端部部分58。第二轴406能够由使用者相对于第一轴404旋转,以旋转螺钉32并调节绳线22a、22b上的张力。护套402、第一轴404和第二轴406的近侧端部部分能够被联接到递送设备的手柄,手柄能够包括允许使用者控制护套402、第一轴404和第二轴406的移动的适当的控制件(例如,旋钮)。
递送设备400和容纳在护套402内的夹具装置10能够被引入患者的脉管系统中(例如,经由股动脉或其他合适的进入点),并且使用各种递送技术中的任何一种,利用小叶夹具装置402经皮推进到患者的心脏。在经股动脉手术中,递送设备400能够在逆行方向上通过股动脉和主动脉插入到心脏(通常但不排他地用于将夹具在主动脉瓣或二尖瓣的小叶上展开)。类似地,递送设备400能够在顺行方向上通过股静脉和腔静脉插入到心脏的右侧(通常但不排他地用于将夹具在肺或三尖瓣的小叶上展开)。在经心室的手术中,递送设备400能够通过在胸部和下前心室壁上的裸露点上形成的手术切口插入(通常但不排他地用于将夹具在主动脉或二尖瓣的小叶上展开)。类似地,递送设备400能够通过右心室壁上的手术切口插入以接近肺或三尖瓣。在经心房手术中,递送设备40能够通过在左心房或右心房的壁上形成的手术切口插入,以分别接近心脏左侧或右侧上的天然瓣膜。在经主动脉的手术中,递送设备400能够通过在升主动脉中形成的手术切口插入并朝向心脏推进(通常但不排他地用于将夹具在主动脉瓣或二尖瓣的小叶上展开)。在经中隔的手术中,递送设备400能够推进到右心房,诸如经由股静脉,并且通过分隔右心室和左心室的隔膜(通常但不排他地用于将夹具在主动脉瓣或二尖瓣上展开)。用于接近心脏的天然瓣膜的递送技术的进一步细节在美国专利公开No.2014/0067052中公开。
一旦定位在期望的心脏瓣膜近侧,小叶夹具装置10就能够从护套402展开,诸如通过使用轴404将夹具装置10从护套402向远侧推动和/或相对于夹具装置将护套402缩回。一旦夹具装置从护套展开,夹具装置就能够向远侧推进,向近端缩回和/或根据需要旋转以定位小叶夹具装置10,使得一对第一和第二小叶大致定位在主要夹持区域24内,其中第一腿部部分28邻近小叶中一个,并且第二腿部部分30邻近另一小叶。
递送设备能够用于调节张紧机构14,直到实现期望的预定植入构型,其中小叶接合并压紧在腿部部分28、30之间。例如,使用者能够旋转轴406,轴406旋转螺钉32,从而增加绳线22a、22b上的张力直到实现植入构型。
在替代实施例中,夹具装置能够包括被配置为接合多对天然小叶的多个夹持构件。如图4所示,例如,小叶夹具装置300包括具有彼此间隔开大约120度的三个夹持构件302、304、306的环形环,每个夹持构件被配置为植入在一对天然小叶上,诸如在天然瓣膜的连合部处。夹具装置300能够包括管状结构,并且由例如形状记忆材料(例如,镍钛诺)或塑性变形材料(例如,不锈钢或钴铬合金)形成。在其他实施例中,夹具装置能够包括具有彼此间隔开大约180度的两个夹持构件的环形环,诸如用于植入在天然二尖瓣的小叶上。
在又一替代实施例中,夹具装置能够包括具有小于其中要植入装置的瓣膜的天然小叶数量的多个夹持构件的开放环(即,延伸小于360度的环)。例如,夹具装置能够包括具有彼此间隔开大约120度的两个夹持构件的开放环,并且被配置为接合两对天然小叶而不是三对天然小叶。
小叶夹具装置能够包括多个不同的张紧机构中的任何一个,张紧机构被配置为向设置在夹持构件内的一根或更多根绳线施加张力并且/或者将夹持构件从递送构型变换成植入构型。例如,图5和图8至图12示出具有不同张紧机构的小叶夹具装置的各种实施例。
图5示出根据另一实施例的小叶夹具装置500。小叶夹具500包括张紧机构502和限定管腔506的夹持构件504。张紧机构502能够包括一个或更多个紧固件508。一根或更多根绳线510能够设置在管腔506内,并且能够在其远侧端部部分512处附接到夹持构件504上的相应位置,如上文结合图1的实施例所述。一根或更多根绳线510能够穿过紧固件508,并且能够具有连接到递送设备和/或延伸到患者身体外部的近侧端部部分。紧固件508(诸如缝合夹)能够在箭头516所示的方向上推进到绳线510上,并且抵靠夹持构件504的中间部分514被推动,以便保持绳线上的张力。绳线的在夹持构件504近侧的部分能够用递送设备或另一工具切断。
紧固件508能够是缝合夹或能够从导管展开并固定到患者体内的缝合线的另一类型的紧固件。能够在本申请中公开的方法中使用的各种缝合夹和用于缝合夹的展开技术在美国公开No.2014/0031864和No.2008/0281356和美国专利No.7,628,797中有所公开。在可滑动紧固件的情况下,紧固件508可沿绳线510在远侧方向上朝向夹持构件移动,并且被配置为阻止在相反方向上沿绳线在近侧方向上移动。因此,一旦抵靠夹持构件放置,紧固件508就能够阻止在绳线的张力下拉动绳线510通过紧固件。以这种方式,紧固件508用作保持构件,以帮助将夹持构件的形状保持在植入构型中。
递送设备能够包括被配置为调节施加到绳线510的张力,直到实现期望的预定植入构型的机构。例如,绳线510能够被可释放地联接到能够由使用者控制的相应轴或其他部件。递送设备还能够包括用于将紧固件508展开到绳线上和/或在绳线上推进紧固件508直到其邻接夹持构件的机构。
图8示出根据另一实施例的小叶夹具装置600。夹具装置600包括张紧机构602和限定管腔606的夹持构件604。张紧机构602能够包括一个或更多个紧固件608(例如,缝合夹)和滑轮系统610,滑轮系统610包括设置在管腔606内的一个或更多个滑轮或槽轮612。一根或更多根绳线614能够设置在管腔606内并且在它们的远侧端部部分616处附接到夹持构件604上的相应位置,如上文结合图1的实施例所述。一根或更多根绳线614能够穿过紧固件608,紧固件608允许绳线614通过紧固件进行一个方向上的运动。如图所示,当绳线614延伸穿过管腔时,绳线614能够在滑轮612周围迂回行进。
递送设备能够包括允许张力被施加到夹持构件604内的绳线614,直到达到期望的预定植入构型的机构,和将紧固件608展开并在绳线614上推进的机构,如上文结合图5的实施例所述。使用滑轮612来支撑绳线614的优点在于通过在绳线上施加拉力,其显著地减小将夹持构件变形为植入构型所需的力。滑轮612也定位在管腔内的战略性位置处,以在绳线上施加张力时促进夹持构件在期望位置处的屈曲。滑轮系统的其他用途可以根据手术需要进一步在绳线上分配张力/负载。
图9示出根据另一实施例的小叶夹具装置700。夹具装置700包括张紧机构702和限定管腔706的夹持构件704。类似于图1的张紧机构14,张紧机构702能够包括螺钉708和设置在螺钉上的螺母710。代替用于张紧机构的单独的壳体,螺钉708能够至少部分地设置在夹持构件的管腔706内。两个壁或突出部718能够在管腔706内位于螺母710的相对侧上,以接触螺母710和防止螺母710在螺钉708旋转时旋转。
如上所述,一根或更多根绳线712能够设置在管腔706内,并且能够在它们的远侧端部部分714处附接到夹持构件704上的相应位置。绳线712能够在它们的近侧端部部分处附接到螺母710。因此,螺钉708的旋转有效地使螺母710沿螺钉轴向地移动,以调节绳线上的张力,如上面结合图1的实施例详细所述。
张紧机构702能够包括呈可变螺距螺钉形式的保持或锁定机构。如图10最佳所示,例如,螺钉708能够包括具有限定第一螺距的螺纹的第一螺纹部分720和具有限定小于第一螺距的第二螺距的螺纹的第二螺纹部分722。螺母710具有对应于第一螺纹部分720的螺纹的内螺纹,并且当螺钉旋转时可以沿螺钉轴向地移动。螺母710的内螺纹与第二螺纹部分722的螺纹大不相同(例如,相比第二螺纹部分的螺纹,螺母710的内螺纹更大并且/或者具有更小的螺距),使得当螺母710到达第二螺纹部分722时,发生机械干涉,机械干涉阻止螺母的进一步移动以帮助将夹持构件保持在其变形状态。
图11示出根据另一实施例的小叶夹具装置800。夹具装置800包括张紧机构802和限定管腔806的夹持构件804。张紧机构802能够包括蜗杆螺钉808和与螺钉808接合的蜗轮或齿轮810。螺钉808和蜗轮810能够安装在管腔806内,其中螺钉808的近侧端部部分暴露在夹持构件外部,用于连接到旋转螺钉的递送设备或工具。蜗杆螺钉808上的旋转或扭矩转换为蜗轮810上的旋转或扭矩。
如前所述,一根或更多根绳线812能够设置在管腔806内并且能够在它们的远侧端部814处附接到夹持构件804上的相应位置。一根或更多根绳线812能够在它们的近侧端部部分处附接到蜗轮810的中心轴816。递送系统中的机构(例如,扭矩轴)能够旋转螺钉808,从而使蜗轮810和轴816旋转。随着蜗轮810旋转,当绳线松弛而围绕轴816缠绕时,张力被施加到一根或更多根绳线812。如图所示,能够使用单个蜗轮810来向多根绳线812施加张力。在替代实施例中,第一和第二蜗轮810能够安装在螺钉808的相对侧上的相应的轴上,其中每个蜗轮810连接到延伸穿过夹持构件的那一侧的相应绳线810。张力能够被施加到夹持构件804内的一根或更多根绳线812,直到达到期望的预定植入构型。
图12示出根据另一实施例的小叶夹具装置900。夹具装置900能够包括张紧机构902和限定管腔906的夹持构件904。张紧机构902能够包括中心锥形齿轮908和例如设置在中心锥形齿轮908的任一侧上的一个或更多个侧锥形齿轮910。每个侧齿轮910能够安装在延伸穿过两个侧齿轮910的相应的轴916或公共轴上。除了能够暴露在夹持构件外部以连接到用于旋转螺钉的递送设备或工具的中心齿轮908的轴部分909之外,齿轮908、910能够安装在管腔906中。中心齿轮908的旋转或扭矩(通过使轴部分909旋转)转换为在两个侧齿轮910上的旋转或扭矩。
如前所述,一根或更多根绳线912能够设置在管腔906内,并且能够在它们的远侧端部部分914处附接到夹持构件904上的相应位置。一根或更多根绳线912中的每个能够在它们的近侧端部部分处附接到相应的侧齿轮910的轴916。递送系统中的机构(例如,扭矩轴)能够使中心齿轮908旋转,从而使侧齿轮910旋转。随着侧齿轮910旋转,当每根绳线松弛而围绕相应的轴916缠绕时,张力被施加到一根或更多根绳线912。张力能够被施加到夹持构件904内的一根或更多根绳线912,直到达到期望的预定植入构型。
考虑到能够应用所公开技术的原理的许多可能的实施例,应当认识到,所示实施例仅是优选示例,并且不应被认为是限制本公开的范围。相反,本公开的范围由所附权利要求限定。
Claims (18)
1.一种小叶夹具装置,其包括:
伸长的夹持构件,其具有第一端部部分和第二端部部分;
张紧机构,其联接到所述夹持构件;以及
一个或更多个张紧构件,其设置在所述夹持构件的管腔内,其中所述一个或更多个张紧构件可操作地连接到所述张紧机构,以将所述夹持构件从递送构型变换成植入构型。
2.根据权利要求1所述的小叶夹具装置,其进一步包括设置在所述夹持构件的所述管腔内的保持机构,其中所述保持机构将所述夹持构件的形状保持在所述植入构型中。
3.根据权利要求1-2中任一项所述的小叶夹具装置,其中,所述夹持构件包括形状记忆材料。
4.根据权利要求1-3中任一项所述的小叶夹具装置,其中,所述张紧机构相对于所述第一端部部分和所述第二端部部分在中心联接到所述夹持构件。
5.根据权利要求1-4中任一项所述的小叶夹具装置,其中,所述一个或更多个张紧构件包括:
第一张紧构件,其在其远侧端部部分处固定到所述夹持构件的所述第一端部部分,并且在所述第一张紧构件的近侧端部部分处可操作地连接到所述张紧机构;以及
第二张紧构件,其在其远侧端部部分处固定到所述夹持构件的所述第二端部部分,并且在所述第二张紧构件的近侧端部部分处可操作地连接到所述张紧机构。
6.根据权利要求1-5中任一项所述的小叶夹具装置,其中,所述张紧机构的至少一部分的旋转引起所述一个或更多个张紧构件的张紧。
7.根据权利要求1-6中任一项所述的小叶夹具装置,其中,所述植入构型包括在所述夹持构件的两个腿部部分之间限定的主要夹持区域。
8.根据权利要求1-7中任一项所述的小叶夹具装置,其中,所述张紧机构包括被配置为将所述夹持构件保持在所述植入构型中的保持机构。
9.根据权利要求1-8中任一项所述的小叶夹具装置,其中,所述一个或更多个张紧构件延伸穿过所述张紧机构的一部分。
10.根据权利要求1-9中任一项所述的小叶夹具装置,其中,所述一个或更多个张紧构件在一个端部处固定到所述张紧机构的一部分。
11.一种小叶夹具装置,其包括:
夹持构件,其包括具有管腔的管状主体和两个腿部部分,其中所述夹持构件能够在基本上线性的递送构型和植入构型之间变换,在所述植入构型中,所述腿部部分被拉向彼此,以将一对小叶捕获在所述腿部部分之间;以及
张紧机构,其被配置为将所述夹持构件从所述递送构型变换成所述植入构型。
12.根据权利要求11所述的小叶夹具装置,其进一步包括设置在所述夹持构件的所述管腔内的一根或更多根绳线,其中所述一根或更多根绳线可操作地连接到所述张紧机构,以将所述夹持构件从所述递送构型变换成所述植入构型。
13.根据权利要求12所述的小叶夹具装置,其中,所述张紧机构的至少一部分的旋转引起所述一根或更多根绳线的张紧,从而导致所述夹持构件从所述递送构型变换成所述植入构型。
14.根据权利要求12-13中任一项所述的小叶夹具装置,其中,所述张紧机构包括螺钉和螺母,所述一根或更多根绳线连接到所述螺母,以便所述螺钉的旋转引起所述螺母沿所述螺钉轴向地移动并且向所述一根或更多根绳线施加张力。
15.根据权利要求11-14中任一项所述的小叶夹具装置,其进一步包括设置在所述夹持构件的所述管腔内的保持机构,其中所述保持机构将所述夹持构件保持在所述植入构型中。
16.根据权利要求11-15中任一项所述的小叶夹具装置,其中,所述管状主体包括金属管,所述金属管具有沿所述管状主体的长度轴向间隔开的周向狭槽。
17.根据权利要求11-16中任一项所述的小叶夹具装置,其中,在所述植入构型中的所述夹持构件具有希腊字母Ω的形状。
18.根据权利要求11-17中任一项所述的小叶夹具装置,其中,当所述夹持构件处于所述植入构型中时,所述腿部部分从所述管状主体的中间部分的相应端部朝向彼此延伸,以限定用于捕获所述一对小叶的夹持区域,所述腿部部分在远离所述夹持区域的方向上彼此远离地延伸。
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US20210228340A1 (en) | 2021-07-29 |
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