CN103561807B - 导管***及其使用方法 - Google Patents
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Abstract
本发明提供了一种模块化导管***,包括:在远端从递送导管伸出的护套(127),递送导管具有主体模块(121);内芯模块(115),其上承载支架,内芯能轴向移动通过递送导管的主体和递送导管护套;由递送导管的主体支撑的把手件(138),把手件能与内芯选择性地轴向接合,使得当把手件与内芯接合时,把手件和内芯可沿轴向方向一起移动;以及由主体支撑的调节件(130),调节件被构造为,通过使把手件相对于主体轴向地滑动,或通过旋转调节件,调节件的旋转引起调节件沿着主体轴向地移动。
Description
优先权要求
本申请要求2011年3月1日提交的美国专利申请第61/448,154号的优先权,通过引用方式将其整体结合于此以供参考。该优先权的权益在适当的法律基础下要求,包括但不限于美国法案第35条119(e)款。
包括的参考文献
2007年1月12日提交的名为“DUALCONCENTRICGUIDEWIREANDMETHODSOFBIFURCATEDGRAFTDEPLOYMENT”(“双同心导丝和分叉移植物布置的方法”)的美国申请第11/623,022号,2008年4月11日提交的名为“BIFURCATEDGRAFTDEPLOYMENTSYSTEMSANDMETHODS”(“分叉移植物布置***和方法”)的美国申请第12/101,863号,2009年7月1日提交的名为“CATHETERSYSTEMANDMETHODSOFUSINGSAME”(“导管***及其使用方法”)的美国申请第12/496,446号,2010年4月28日提交的名为“APPARATUSANDMETHODOFPLACEMENTOFAGRAFTORGRAFTSYSTEM”(“放置移植物或移植物***的设备和方法”)的美国申请第12/769,506号,以及名为“ENDOLUMINALVASCULARPROSTHESIS”(“腔内人造血管”)的美国专利第6,077,296号,以上专利将通过引用方式整体结合于此。
技术领域
本公开涉及导管***,特别是用于递送医用假体的导管***。
背景技术
引导器导管或引导器护套可用于将导管以最小创伤的方式放置于血管中。引导器导管护套典型地包括:***血管中的管道;以及管道的定位在身体外部的近端处的密封件或阀。密封件可提供止血密封以防止失血。典型地,支架或其他医用假体穿过引导器护套,进入血管或身体通道。因此,引导器护套可为支架或其他医用假体的递送提供连续的通路,当支架或其他假体穿过身体通道前进时防止血管或身体通道的内壁受到损伤,并且提供防止失血的止血密封。
在某些情况下导管的主要操作需要基本在血管内。例如,支架或支架移植物的放置可能需要将递送导管以精确地轴向并且可旋转的方式定位在血管内的特定位置。另外,支架的布置可能需要递送***在引导器内的精确操作。在这些情况中,操作员必须仔细地控制引导器和递送***两者的位置。需要有一种递送***以允许用户或医疗从业者在布置过程中精确地控制支架或假体的轴向位置。
发明内容
这里公开的实施方式涉及一种导管***,用于将诊断或治疗装置***并定位在血管中。该***包括引导器或引导器护套(在这里也叫做外护套),以及至少一个递送导管。可将引导器导管经皮穿刺位置引导至血流中。对接机构可将引导器导管组件的近端与递送导管的远端部分接合,并可防止引导器导管组件与递送导管组件之间的轴向运动。
导管***可包括引导器导管和递送导管,其中,引导器导管包括外护套和密封件,密封件具有与外护套的近端部分连接的可调节止血阀。可将引导器导管和递送导管构造为使得递送导管能够与引导器导管可移除地接合,使得,当递送导管与引导器导管接合时,递送导管能够轴向地固定至引导器导管,以防止引导器导管与递送导管之间实质的轴向运动,并使这些导管能够在轴向方向上作为一个单元操作。
或者,可将递送导管和引导器导管构造为,使得,当递送导管与引导器导管接合时,递送导管的内芯能够相对于引导器导管和引导器护套(在这里也叫做外护套)旋转。或者,可将递送导管构造为,使得,其内芯能够被锁定,或基本防止其相对于引导器导管的外护套和/或相对于引导器导管的旋转运动。还公开了一种将支架或医用假体放置于血管中的方法,其中,支架或医用假体穿过引导器护套,并且,引导器导管的近端与递送导管的远端部分物理地接合或与该远端部分可移除地对接,以防止引导器护套与递送导管之间的实质的轴向运动。
包括支架、移植物、支架移植物和解剖处理装置等一些内假体(所有这些内假体在这里全部叫做支架)可能需要在轴向和旋转方向上精确地放置。例如,具有开窗部的支架或支架移植物需要将那些开窗部相对于分支血管精确地放置。这里公开的导管***可构造为,允许递送导管(以及因此也允许支架)相对于引导器护套的旋转。在一些实施方式中,可通过在布置导管的引导器护套和/或管状护套的内表面加衬低摩擦涂层(例如,PTFE,硅树脂,疏水性硅树脂,或其他润滑物质),或通过对递送导管的内芯或限制护套的外表面施加亲水性涂层,来进一步减小摩擦,所述摩擦可能妨碍递送导管的旋转自由度。润滑剂可被涂抹在目标表面上。
因此,当使递送导管在引导器护套内旋转时,引导器护套保持可旋转地静态或固定。这可在递送导管和支架的旋转操作过程中,防止递送导管和支架损坏、扭转或受压,并且也防止由于递送导管或支架的旋转引起血管壁上的任何损坏或应力。
另外,可将递送导管构造为允许用户或医疗从业者选择性地控制或阻止递送导管和支架相对于引导器导管的旋转运动,或递送导管的内芯和支架相对于递送导管的外护套的旋转运动。例如,递送导管可包括被支撑于递送导管的近端部分处的螺纹毂,该螺纹毂构造为选择性地压紧或绷紧抵靠递送导管的内芯的外壁。通过使毂压紧抵靠内芯,可防止或阻止内芯相对于引导器导管旋转。通过使毂相对于内芯放松,可恢复递送导管的内芯相对于引导器护套的旋转自由度。
附图说明
现在,将参考附图,结合某些实施例描述这些和其他特征、方面和优点。然而,所示实施例仅是实例且目的并不在于限制性的。以下是附图的简要描述。
图1A是导管***的示意图,导管***包括将导管与引导器护套物理地接合的对接设置。
图1B是图1A中所示的导管***的示意图,示出了与引导器护套接合的导管。
图2A是另一导管***的示意图,该导管***包括将导管与引导器护套物理地接合的对接设置。
图2B是图2A中所示的导管***的示意图,示出了与引导器护套接合的导管。
图2C是图2A中所示的导管***的示意图,示出了用于使导管与引导器护套脱离的机构。
图3A是另一导管***的示意图,该导管***包括将导管与引导器护套物理地接合的对接设置,导管***配置为能将支架或支架移植物递送至血管中。
图3B是图3A中所示的导管***的示意图,示出了与引导器护套接合的导管。
图3C是图3A中所示的导管***的示意图,示出了支架轴向地***到图3A中所示的引导器护套的管状护套中。
图3D是图3A所示的导管***的示意图,示出了图3A中所示的引导器护套的管状护套已从支架收回之后支架的布置。
图4是导管***的倾斜视图,该导管***包括引导器和递送导管。
图5是图4中所示的引导器的倾斜视图。
图6A是图5中所示的引导器的第一分解装配图。
图6B是图5中所示的引导器的第二分解装配图。
图7是图4中所示的递送导管的倾斜视图。
图8A是图7中所示的递送导管的第一分解装配图。
图8B是图7中所示的递送导管的第二分解装配图。
图9是图4中所示的导管***的倾斜视图,示出了在递送导管的对接机构已与引导器的对接机构接合之前的递送导管。
图10是图4中所示的导管***的倾斜视图,示出了在递送导管的对接机构已与引导器的对接机构接合之后的递送导管。
图11是图4中所示的导管***的端视图。
图12是图4中所示的导管***在图11的线12-12处截取的横截面图。
图13是图4中所示的导管***的放大的横截面图,示出了图12中的13-13处的特写。
图14是图4中所示的导管***的放大的截面图,示出了图13中的14-14处的特写。
图15是图4中所示的导管***在图11中的线15-15处截取的横截面图。
图16是导管***的倾斜视图,该导管***具有与引导器导管组件对接的递送导管组件。
图17是图16的递送导管组件的倾斜视图。
图18是图16的递送导管组件的顶视图。
图19是图16的递送导管组件的侧视图。
图20是图16的递送导管组件的倾斜视图,示出了相对于内芯件处于完全收起位置中的护套。
图21是图16的递送导管的侧视图,示出了相对于递送导管的壳体轴处于预布置(pre-deployment,预展开)第一位置中的把手件和内芯。
图22是图16的递送导管的侧视图,示出了相对于递送导管的壳体轴处于第二、部分布置位置中的把手件和内芯。
图23是图16的递送导管的侧视图,示出了位于递送导管的壳体轴上的第三、完全伸出位置(advancedposition)中的把手件和内芯。
图24是内芯接合组件和内芯的倾斜视图,示出了相对于内芯接合组件处于第一、分离位置中的内芯,为了清晰起见,递送导管的其他部件被从此视图中移除。
图25是通过递送导管的轴向中心线截取的递送导管的一部分的横截面图,示出了相对于内芯接合组件处于第一、分离位置中的内芯。
图26是如图24中所示的内芯接合组件和内芯的倾斜视图,示出了相对于内芯接合组件处于第二、部分接合位置中的内芯。
图27是如图26中所示的内芯接合组件和内芯的侧视图,示出了相对于内芯接合组件处于第二、部分接合位置中的内芯。
图27A是通过图29的线27A-27A截取的递送导管的一部分的横截面图,示出了处于第一位置中的递送导管的一个或多个部件。
图27B是通过图29的线27A-27A得到的递送导管的一部分的横截面图,示出了处于第二位置中的递送导管的一个或多个部件。
图28是如图26中所示的内芯接合组件和内芯的顶视图,示出了相对于内芯接合组件处于第二、部分接合位置中的内芯。
图29是通过递送导管的轴向中心线截取的递送导管的一部分的横截面图,示出了相对于内芯接合组件处于第二、部分接合位置中的内芯。
图30是如图24中所示的内芯接合组件和内芯的倾斜视图,示出了相对于内芯接合组件处于第三、接合位置中的内芯。
图31是如图30中所示的内芯接合组件和内芯的侧视图,示出了相对于内芯接合组件处于第三、接合位置中的内芯。
图32是如图30中所示的内芯接合组件和内芯的顶视图,示出了相对于内芯接合组件处于第三、接合位置中的内芯。
图33是通过递送导管的轴向中心线截取的递送导管的一部分的横截面图,示出了相对于内芯接合组件处于第三、接合位置中的内芯。
图34是通过递送导管的轴向中心线截取的递送导管的一部分的横截面图,示出了相对于内芯接合组件处于分离位置中的内芯。
图35是通过递送导管的轴向中心线截取的递送导管的一部分的横截面图,示出了相对于内芯接合组件处于接合位置中的内芯。
图36是通过递送导管部分地布置的假体的图示。
图37是可通过图36中所示的递送导管布置的示意性的支架的侧视图。
图38是具有引导器导管组件的导管***的示意性侧视图,示出了装在引导器导管的外护套内的支架。
图39是具有布置导管组件的导管***的示意性侧视图,示出了支撑于其中的支架,以及装在递送导管中的分支血管线组件(branchvesselwireassembly)。
图40是分支血管线组件在图39的线40-40处得到的横截面图。
图41是图39的分支血管线组件的部分41-41的放大示意图。
具体实施方式
现在,以下详细说明涉及某些特定实施方式。在本说明书中,参考附图,其中,在整个说明书和附图中用相似的数字表示相似的零件。下面描述了可包括引导器护套和对接装置的导管***的多个实施例。这里公开的导管***可使用在诊断或治疗过程中,例如,但不限于,腔内血管假体布置过程中。
图1A是导管***10的示意图,其包括被构造为将导管20与引导器12物理地接合的对接装置。图1B是图1A中所示的导管***10的示意图,示出了与引导器12接合的导管20。导管20或者这里公开的任何导管均可以是诊断或治疗导管,或任何其他适合的导管。引导器12可包括管状护套14、密封件16、以及凹对接机构18。第一密封件16可以是橡胶密封件、相邻部件之间的干涉或紧公差配合、可调节止血阀、或任何其他适合的密封部件或特征。
导管20具有轴24和凸对接机构22。如图1B中所示,导管20***引导器12中,并且凹对接机构18与凸对接机构22接合。当对接机构接合时,对接机构防止引导器12和导管20相对于彼此轴向地移动。另外,导管***10构造为,使得,即使当使导管20与引导器12对接后,导管20也可在引导器12内旋转。
引导器12包括管状引导器护套14和密封件16(同样,其可以是橡胶密封件、干涉或紧公差配合、可调节止血阀、或任何其他适合的密封部件或特征),该密封件与引导器护套14的近端连接。护套14和密封件16的整体设计可与商业上可获得的引导器,或任何其他目前已知的或稍后开发的引导器的设计相似。导管20具有外部尺寸轮廓(横截轮廓),其尺寸设定为和/或结构构造为可穿过引导器护套14。导管20的近端和引导器护套14的近端构造为彼此永久地或可移除地接合,以及构造为在基本上限制导管20相对于引导器护套14的轴向运动的同时,允许导管20在引导器护套14内旋转。
关于相对于对外护套(容纳支架移植物)的尺寸确定引导器内腔的尺寸,在一种结构中,它们具有相同的尺寸,并且,当将支架移植物从其在外护套内的初始位置被推入到引导器内腔时,引导器用作护套。在第二结构中,引导器内腔比外护套的外径大,并且,当需要旋转对准时,这两者轻松地相对于彼此旋转。此外,引导器材料可以是比外护套更软或更柔性的材料,因此虽然最初能将支架移植物装入坚固的高强度护套材料中,但对于将支架移植物递送至其治疗位置所需的短时间而言,可将支架移植物挤出穿过更低强度且更柔性的引导器材料。可能用来提供此特征的材料包括任何类型的软质聚合物挤出物,包括尼龙,PEBAX和PE。
在导管和引导器接合之后,组合的***可由一个操作员操作。导管***10构造为,使得导管20基本能在引导器护套14内自由地旋转,这可允许将导管精确地旋转定位在引导器内。在完成该过程(procedure,手术)之后,导管20与引导器12分离,使得导管20可从患者的身体移除。另外,可重新定位引导器12以进行第二次***,并且第二导管可以***并与引导器12接合,以进行另外的手术。
图2A是导管***40的示意图,该导管***包括将导管50与引导器42物理地接合的对接装置。图2B是导管***40的示意图,示出了与引导器42接合的导管50。图2C是图2A中所示的导管***40的示意图,示出了用于使导管50与引导器42分离的机构。
特别地,图2C示意性地图示出,通过压缩控制杆或凸出部56,可使导管50与凸对接机构52和引导器42分离。因此,如所图示出的,凸接合机构52可以是细长的,并且,可包括控制杆56。
图3A是导管***60的示意图,该导管***包括将导管70与引导器62物理地接合的对接装置,导管***60构造为用于将支架或支架移植物80递送至血管中。
图3B是图3A中所示的导管***60的示意图,示出了与引导器62接合的导管70。图3C是图3A中所示的导管***60的示意图,图示出了支架或支架移植物80进入图3A中所示的引导器62的管状护套64内的轴向***。图3D是图3A中所示的导管***60的示意图,图示出了在图3A中所示的引导器62的管状护套64已从支架80收回之后支架80被布置。
自扩展的支架或支架移植物典型地被保持在递送导管内的布置护套中。布置的护套可防止支架或支架移植物以及血管壁在***过程中损伤,并且,可在递送过程中将支架或支架移植物保持在折叠的低轮廓结构中。可通过移除布置的护套并允许支架或支架移植物抵靠血管壁径向扩展,支架或支架移植物可以在血管的所需位置布置。为了使这种递送导管进入所需血管,导管***可构造为,使得引导器护套的内径比布置的护套的外径大。临床医生更喜欢低轮廓的引导器护套,以将对血管的损伤减到最小并能够进入小血管。
弹筒式***已经被开发出,在该***中,支架或支架移植物可从递送护套被传送至引导器护套中,并且支架或支架移植物可通过引导器护套到达目标位置。在这种弹筒式***中,引导器护套有效地用作布置的护套。该传送去除了第二护套的需求,并且将***在血管中的轮廓减到最小。对接装置提供了将支架或支架移植物移动至引导器护套中之前递送导管和引导器护套的牢固接合。这防止传送中***错误,并进一步将递送导管和引导器护套转变成单用户***。
如图3A至图3D中所示,导管***60被用来在血管(血管未示出)中传送并布置支架或支架移植物80。如这里图示出的,引导器62包括***病人身体中的管状护套64。引导器62的近端62a的尺寸设定为和/或结构构造为,用于容纳导管70的布置护套74。引导器护套也可具有密封件66(在这里叫做第一密封件)和凹对接机构68,与任何上述的密封件、止血阀和/或对接机构的实施方式相似。密封件66可以是环形橡胶密封件(如所图示出的)、相邻部件之间的干涉或紧公差配合、可调节止血阀、或任何其他适合的密封部件或特征。支架递送导管70可包括内芯78、可容纳折叠支架80的小袋82、可保持折叠支架80的展开护套74,以及导管尖端76。
如图3B中所图示,当使对接机构68和72接合时,导管70可被***引导器62中。在一些实施方式(未图示出)中,可将递送导管70的布置护套74的尺寸设定为和/或结构构造为,能被容纳于引导器护套的更大直径的近端62a内,并伸入引导器62的远端管状护套64中。或者,可将递送导管70的布置护套74的尺寸设定为和结构构造为,能被容纳于引导器护套的更大直径的近端62a内但是不能容纳于引导器62的远端管状护套64内。在一些实施方式中,如图3C和图3D中所示,可将布置护套74和管状护套64的尺寸设定为和结构构造为,当布置护套74已经前进通过了引导器护套的近端62a时,远端管状护套64的相同尺寸或形状可阻止布置护套74前进通过远端管状护套64。布置护套74和管状护套64的内径和/或外径可基本上是相同的。
如图3C中所图示,导管70的内芯78可在远端被推动,从而将支架80从布置护套74传送至引导器62的管状护套64中。支架80可以被推进直到导管尖端76到达管状护套64的远端。在此结构中,导管/引导器***有效地变成单单元布置导管。因此,管状护套64可用作布置护套。支架80能够在保护引导器62内以折叠结构被推进至血管中的目标位置,不会增加递送***的轮廓。如果使递送导管通过传统的引导器护套,则引导器的护套将必须具有比递送导管的布置护套大的直径,以容纳支架和布置护套。2)提到的其他优点是:
在所述结构中,可在已将装置引导至引导器之后但在所述装置展开之前旋转该装置,由于引导器和外护套之间的低摩擦而进一步地使该装置精确地定位。当要使用具有25和28mm直径的扩展直径的装置时,任一个装置的递送和两个装置的递送均可使用相同的(一种尺寸的)引导器护套。仅当要递送更大的34mm直径的装置(具有更大的压缩横截轮廓)时,才必须使用更大的引导器。事实上引导器和递送导管机械地接合并产生可由一只手握持的单一整体结构,允许一个用户用两只手操作整个***:一只手保持芯部静止,另一只手操作护套收回机构。
如本领域中已知的,装有支架移植物的递送导管典型地具有比用扩张器支撑的引导器护套更小的可跟踪性和可推性。这是由于支架移植物改变了导管的局部硬度。这会引起递送导管在***过程中产生扭结。通过首先用扩张器布置引导器护套,建立了用于放置支架移植物的管道。通过护套的递送***的扭结是不太可能产生的。
图4是另一导管***100的倾斜视图,该导管***100包括引导器护套102(也叫做引导器)和递送导管104。递送导管104可被构造为用于递送腔内假体,或用于任何其他适当的用途。因此,这里公开的导管和引导器的实施方式可被构造为用于任何适当目的,并且这里公开的引导器的实施方式可构造为用于接收任何适当的导管设计。
图5是图4中所示的导管***100的引导器102的倾斜视图。图6A和图6B是图中5所示的引导器102的第一和第二分解装配图。参考图4至图6,引导器102可具有主体106、可螺纹接合的毂部分108、引导器护套110,以及被构造为与主体106的螺纹端部分螺纹地接合的螺帽111。
在一些实施方式中,第一管道107可被主体106支撑以提供进入主体106的孔或入口。在任何阶段可使用第一管道107用盐水或其他适当的物质冲洗引导器102,所述阶段例如但不限于,在腔内假体通过引导器102前进之前,或在其他可使用引导器的过程之前。第一管道107可在其远端上支撑任何适合的医用连接器和/或阀。
引导器护套110可具有延伸至任何预定或所需长度的细长部分110a。如将在下面更详细地讨论的,与上述导管***10的引导器12相似,可将引导器护套110构造为,使得前进到引导器护套110中的腔内假体可被引导器护套110约束或限制。在此装置中,引导器护套110的内径和/或外径可与跟引导器102接合的递送导管的外护套的内径和/或外径大约相同或相似。细长部分110a的横截面可以是圆形的(如所图示出的),或者可定义任何适当的横截面形状,例如,但不限于,三角形、正方形、六角形、八角形、或多角形。
此外,如在图6A中最清晰地示出的,引导器护套110可具有漏斗状端部110b,漏斗状端部110b可被构造为与主体106的前表面106a邻接。参考图6A,引导器护套110的细长部分110a可穿过形成于帽111中的开口,使得引导器护套110的漏斗状部分110b能够与帽111的内表面接合和/或重叠。在此结构中,支撑引导器护套110的帽111可与主体106螺纹接合,使引导器护套110可被主体106支撑。
另外,参考图6A和图6B,管状支撑或隔离件109可被***在引导器护套110的细长部分110a上并且可大约定位在邻近漏斗状部分110b处。管状隔离件109可改进配合,因此也改进了引导器护套110的外表面和帽111之间的密封。管状隔离件109也可以对引导器护套110提供额外的支撑。
图7是图4中所示的导管***100的实施方式的递送导管104的倾斜视图。
图8A和图8B是图7中所示的递送导管104的第一和第二分解装配图。
图9是图4中所示的导管***100的倾斜视图,示出了在递送导管104的对接机构与引导器102的对接机构接合之前的递送导管104。
图10是图4中所示的导管***100的倾斜视图,示出了在递送导管104的对接机构已与引导器102的对接机构接合之后的递送导管104。
图11是图4中所示的导管***的端视图,其中递送导管104与引导器102接合。图12是在图11的线12-12处得到的图4所示的导管***100的实施方式的截面图。图13是由图12的曲线13-13定义的图4中所示的导管***100的放大截面图。图14是由图13的曲线14-14定义的图4中所示的导管***的实施方式的放大截面图。最后,图15是在图11的线15-15处得到的图4所示的导管***的截面图。
如图12和图15中最清晰地示出的,引导器102的毂部分108可具有对接机构或凸缘112,或可被构造为可移除地接收递送导管104或与递送导管104接合。在一些实施方式中,如所图示实施方式中,引导器102的对接机构112可被构造为凹接收器,凹接收器被构造为接收导管104的凸对接件,如将在下面描述的。毂部分108可包括一个或多个凸出部114,凸出部114被构造为改进用户在毂部分108上的握持,并改进毂部分108相对于主体106旋转的能力。
参考图12、13和15,将描述引导器102的密封部分的一些实施方式。如上所述,毂部分108可被构造为可与主体106螺纹接合。主体108可定义内环形面116,内环形面116可具有一定角度(以与导管***100的轴向中心线不垂直)。表面116相对于导管***100的轴向中心线的角度可为大约75度,或者相对于导管***100的轴向中心线的角度可为从大约65度或更小至大约80度或更大。表面116可大约垂直于导管***100的轴向中心线。
类似地,毂部分108可定义内环形面118,内环形面118可具有一定角度,以与导管***100的轴向中心线不垂直。毂部分108的表面118相对于导管***100的轴向中心线的角度可为大约75度,或者,角度可为从大约65度或更小至大约80度或更大,并且相对于导管***100的轴向中心线在与主体106的表面116所定义的角度的方向的相反方向上。在一些实施方式中,如所图示实施方式中,毂部分108的表面118的形状和角度定向可与主体106的表面116的形状和角度定向大约为镜像。表面118可大约垂直于导管***100的轴向中心线。
环形密封件120可由引导器102支撑,并定位在主体106的表面116与毂部分108的表面118之间。密封件120可由弹性材料形成,例如硅树脂、橡胶或任何其他适当的材料。密封件120可被构造为,当毂部分108螺纹连接在主体106上时,使得毂部分108的表面118可以轴向地朝着主体106的表面116移动,从而压缩或挤压密封件120。主体106的表面116和毂部分108的表面118的相对角度会引起将密封件120被压迫抵靠在递送导管104的外护套122上或递送导管104的与引导器102接合的其他部件上,从而在递送导管104的外护套122与引导器102之间产生可调节的密封,外护套122可从递送导管104的端部在远端伸出。可通过相对于引导器102的主体106张紧或松开引导器102的毂部分108,来调节密封的程度。引导器102可被构造为提供具有轮廓范围从1Fr到20Fr的相对于装置的密封。
或者,在一些实施方式中,这里描述的任何密封件或密封部分均可以是相邻部件(例如,外护套122与引导器102的主体106或毂部分108的一个或多个内表面)之间的干涉或紧公差配合。在一些实施方式中,这里描述的任何密封件或密封部分均可以是内芯154和导管104的主体140或毂部分142的一个或多个内表面之间的干涉或紧公差配合。
如图7、8A和8B中所示,递送导管104的一些实施方式可包括主体140以及可与主体140螺纹接合的毂部分142。递送导管104的一些实施方式也可具有由主体140支撑的外护套122。特别地,外护套122可用由主体140螺纹支撑的帽123,被主体140可移除地支撑。此外,外护套122可具有延伸至任何预定或所需长度的细长部分122a。
如上所述,递送导管104的外护套122的内径和/或外径可与引导器护套110的内径和/或外径大约相同或相似。细长部分122a的横截面可以是圆形的(如图示),或者可定义为任何适当的横截面形状,例如,但不限于,三角形、正方形、六角形、八角形或多角形。
外护套122可具有漏斗状端部122b,该漏斗状端部可被构造为与主体140的前表面140a邻接。参考图8A,外护套122的细长部分122a可通过形成于帽123中的开口,使得外护套122的漏斗状部分122b与帽123的内表面能够接合和/或重叠。在此结构中,如上所述,支撑外护套122的帽123可与主体140螺纹接合以使外护套122被主体140支撑。
另外,参考图8A和图8B,管状支撑或隔离件125可被***到外护套122的细长部分122a上并且大约定位在外护套122的漏斗状部分122b附近。管状隔离件125可改进配合,并由此改进外护套122的外表面和帽123之间的密封。管状隔离件125还可对外护套122提供额外的支撑。
与引导器102的毂部分108类似,递送导管104的毂部分142可被构造为与递送导管104的主体140螺纹接合。主体140可定义内环形面146,内环形面可具有一定角度以与导管***100的轴向中心线不垂直。表面146相对于导管***100的轴向中心线可呈大约75度的角,或者相对于导管***100的轴向中心线呈从大约80度或更大至65度或更小的角。表面146可大约垂直于导管***100的轴向中心线。
在一些实施方式中,第二管道141可被主体140支撑以提供通向主体140的孔或入口。在任何阶段均可使用第二管道141用盐水或其他适当的物质冲洗递送导管104,所述阶段例如但不限于,在腔内假体在递送导管104和/或引导器102内前进之前,或在其他可能使用递送导管的过程之前。第二管道141可在其远端上支撑任何适当的医用连接器和/或阀。
类似地,毂部分142可定义内环形面148,该内环形面可具有一定角度以与导管***100的轴向中心线不垂直。毂部分142的表面148相对于导管***100的轴向中心线可呈大约75度的角,或者在与主体140的表面146所定义的角度的方向相反的方向上,相对于导管***100的轴向中心线,呈从大约65度或更小到大约80度或更大的角。表面148可大约垂直于导管***100的轴向中心线。
与引导器的情况相似,在一些实施方式中,包括环形密封件150的密封或密封部分可由递送导管104支撑,并定位在主体140的表面146与毂部分142的表面148之间。密封件150可由弹性材料(例如,硅树脂、橡胶或任何其他适当的材料)形成。密封件150可被构造为,使得当毂部分142被螺纹连接在主体140上时,毂部分142的表面148可朝着主体140的表面146轴向地移动,从而压缩或挤压密封件150。主体140的表面146与毂部分142的表面148的相对角度会引起密封件150被压迫抵靠递送导管104的内芯154上,从而在内芯154与递送导管104的外护套122之间生产可调节的密封。
可通过相对于递送导管104的主体140张紧或松开递送导管104的毂部分142,来调节密封的程度。可通过如上所述地张紧密封件150,来阻止或防止递送导管104的内芯154的旋转自由度。因此,密封件150施加在内芯154上的力可以被调节以允许内芯154和/或其他部件相对于递送导管104的主体140和毂部分142旋转。如图4中所示,端部或帽158可被支撑于内芯154的近端处以便于用户能够使得内芯154相对于递送导管104的主体140和毂部分142轴向地滑动和/或旋转。帽158可具有形成于其上的翼部或凸出部以增加可施加在内芯154上的扭矩或旋转力。或者,导管104内的密封件或密封部分可由相邻部件(例如但不限于,内芯154与导管104的主体140或毂部分142的一个或多个内表面)之间的干涉或紧公差配合形成。
内芯154在其远端附近可具有带子或其他标记155。标记155的尺寸,位置和结构可被设计为,当使内芯154被推进引导器102中时或被从引导器102收回时,对医疗从业者提供有关于内芯154的端部154a的位置和/或导管尖端162的位置的可视指示。
在一些实施方式中,如在图12和图13中最清晰地示出的,额外的密封件160可被引导器102的主体106支撑以在递送导管104的外护套122与引导器102之间提供额外的密封。密封件160可以是由一块圆锥形弹性材料形成的瓣型密封,例如,但不限于,其中具有一条或多条缝隙以允许远端162和外护套122从中通过的橡胶。在一些实施方式中,支撑凸缘161可被支撑于主体106内,并被定位在密封件160的后面以支撑密封件160并保持密封件160的位置,使得当递送导管104从引导器102被移除时,密封件160不会变得反转。远端162可由软质材料(例如橡胶)形成,并可被构造为是无创伤的以在导管104通过病人的血管***前进时防止对病人的血管***产生任何损伤。
如上所述,在一些实施方式中,如所图示实施方式中,引导器102的对接机构112可被构造为,接收导管104的凸对接件或一部分。特别地,参考图7、8A和8B,一个或多个可偏转的凸出部(tab,调整片)170可由导管104的主体140支撑。通过按压衬垫172或者对衬垫172施加径向向内的力,可使凸出部170偏转,引起凸出部170的端部朝着主体104的轴向中心线径向向内移动。通过使凸出部170向内偏转,导管104的主体140可被轴向移动成与引导器102的毂部分108接合。当导管104的主体140轴向移动成与引导器102的毂部分108接合时,凸出部170可自动地向内偏转。一旦导管104的主体140轴向移动成与引导器102的毂部分108接合,从而与引导器的毂部分108邻接时,凸出部170可被释放,从而将导管104的主体140可移除地锁定至引导器102的毂部分108。
在此结构中,导管104可与引导器102轴向地接合或被锁定至引导器102,使得用户可同时轴向操纵引导器102和导管104两者。另外,在一些实施方式中,在此结构中,如上所述,导管***100可被构造为,使得至少导管104的内芯154可相对于导管104的主体140和引导器102旋转。
在一些实施方式中,如图7、8A和8B中所示,内芯154具有中心管或线176以支撑支架,所述支架例如,图7和图12至图14所示的支架157。另外,一个或多个珠状部或凸出部174可形成在中心管或线176上,或者由中心管或线176支撑。凸出部174可被构造为,当折叠结构的假体被中心管176支撑时,增加内芯154与由中心管176支撑的腔内假体之间的轴向支撑或连接。导管104可被构造为,使得开口通过远端162、中心管176和内芯154。开口可被构造为使得至少远端162、中心管176和内芯154能够在定位于病人的脉管***内的导丝上前进,例如,在2008年4月11日提交的美国专利申请第12/101,863号(名称:BIFURCATEDGRAFTDEPLOYMENTSYSTEMSANDMETHODS(分叉移植物布置***和方法))中所描述的,该申请通过引用方式将其整体结合于此。
另外,在一些实施方式(未图示出)中,凸出部174的尺寸、间隔和结构可被设计为,对多个单独的支架段提供轴向支撑。例如,但不限于,多个独立的或束缚的支架段可被定位在管状或分叉的移植物内,并且支架移植物可相对于凸出部174被定位,以使凸出部174被定位在支架段之间。此装置可减小外护套122、引导器护套110和其他包括导管***的部件的总直径,可增强凸出部174提供给腔内假体的轴向支撑,并可允许支撑力在凸出部174与腔内假体之间的更均匀分布。凸出部174的尺寸、间隔和结构可被设计为便于定位在形成于管状或分叉的支架中的连接部、弯曲部、环圈和/或其他连接器附近,例如,包括在名为ENDOLUMINALVASCULARPROSTHESIS(腔内血管假体)的美国专利第6,077,296号中公开的支架的实施方式的连接部、弯曲部、环圈和/或连接器,该专利通过引用方式将其整体结合于此。
参考图13-图15,布置导管104与引导器102接合时,可使布置导管104的外护套122进入引导器102内的轴向开口。外护套122的尺寸和结构可被设计为,使得外护套122的远端部分122c可在引导器护套110的近端或漏斗部分110b的前面或附近终止于引导器102内。尽管不需要,但是引导器102可具有形成于引导器的主体106中的收缩部分113。在一些实施方式中,如在图14中最清晰地示出的,导管***100可被构造为使得外护套122的远端122c终止于引导器102的主体106的收缩部分113的前面或大约其附近。
在一些实施方式(未示出)中,外护套122的远端部分122c可被定位在引导器护套110的近端部分或漏斗部分110b附近或大约其附近,不管导管104是否具有收缩部分113。收缩部分113的内径可与外护套122的内径和/或引导器护套110的内径大约相同。
因此,导管104的外护套122和引导器护套110可被构造为,在导管***中提供具有通常均匀的横截面尺寸的内腔,腔内假体可穿过该内腔前进。贯穿导管***100的内腔(腔内假体可穿过该内腔前进)可以是基本连续的,使得腔内假体可穿过导管***100前进,并且当假体前进时,假体不会被导管***100的任何部件或特征阻碍,或者假体不会被该部件或特征挂住。内腔可以是基本连续的,但是在内腔中具有大约1mm至大约3mm的等级的短间隙,例如,但不限于,在邻近导管104的外护套122的远端和/或邻近引导器护套110的近端或漏斗端110b处。例如,在一些实施方式中,当使包括导管***100的一些部件与包括导管***100的其他部件螺纹接合时,在邻近导管104的外护套122的远端和/或邻近引导器护套110的近端或漏斗端110b处可形成短间隙。此外,在一些实施方式中,除了外护套122和引导器护套110以外,包括导管104或引导器102的其他部件的一个或多个表面,例如,但不限于如上所述的引导器102的主体106的收缩部分113,可形成贯穿导管***100的内腔的部分。
如上所述,外护套122可约束或限制由中心管176支撑的腔内假体。在此结构中,当使导管尖端162、中央芯154和腔内假体(例如,但不限于,图7和图12-图14所图示的支架157)穿过外护套122前进时,外护套122可限制腔内假体,并防止腔内假体在到达患者的脉管***内的目标位置之前张开。另外,导管***100可被构造为,使得当导管尖端162、中央芯154和腔内假体前进得超过了外护套122的远端122c时,随着腔内假体前进通过引导器护套110,收缩部分113且然后是引导器护套110可径向地限制腔内假体。
腔内假体或支架157可以是管状支架、分叉支架、或任何其他所需的支架、移植物、支架移植物、或腔内假体(这里都叫做支架),包括但不限于,在上述美国专利申请第12/101,863中公开的任何支架或移植物,该专利通过引用方式将其整体结合于此。因此,导管***100或导管104可被构造为用于布置任何适当的或所需一个或多个的支架。
因此,在此结构中,腔内假体可从外护套122被传送至引导器护套110。在此装置中,用引导器护套110作为约束可允许减小引导器护套110的外径,这可将对患者的脉管***的损伤减到最小,并帮助布置腔内假体。
已经结合图1-图15描述了对接机构和导管***的许多实施方式。对于本领域中的普通技术人员来说,显而易见的是,有许多永久的或可移除的对接机构的潜在实施方式,这些实施方式可适合于医用并且是在这里被考虑到的。例如,在一些实施方式中,螺母-螺钉组合可被用来连接引导器护套和导管。作为另一实例,也可使用螺口型锁定机构(例如用于照相机镜头的螺口型锁定机构)。在一些实施方式中,这里公开的导管或本领域中可获得的其他导管的一些实施方式的任何部件或特征可以被组合以形成额外的实施方式,这里考虑到了所有这些实施方式。
图16中公开的导管***具有引导器导管组件(在这里也叫做引导器导管)和递送导管组件(在这里也叫做递送导管)。
这里公开的导管***可被用于诊断或治疗过程,例如,但不限于,腔内血管假体布置过程。对于本领域中的技术人员显而易见的是,这里公开的导管***实施方式可被用于递送假体,所述假体通常用于支撑身体组织,以及各种血管和动脉瘤。可用这里公开的导管***实施方式治疗的血管的实例包括主动脉、主动脉瘤(例如腹主动脉瘤)、隐静脉移植物、腔静脉、肾动脉,髂动脉,股动脉,腘动脉,颈动脉,颅动脉,肺动脉,等等。可用这里公开的一些导管***实施方式治疗的其他器官或身体组织包括***、胆道、食道、气管、输卵管、输精管、输尿管、泪腺、唾液管。
这里公开的导管系可被统构造为布置很大范围的腔内假体,其中包括可机械扩展的支架、自扩展支架、药物洗脱支架、移植物、分叉的和不分叉的支架移植物、有孔的支架移植物、肾上腺支架延伸部、支架段、解剖治疗装置、可布置在身体的任何适当区域中的医用假体,以及在2008年4月11日提交的美国申请第12/101,863号,2009年7月1日提交的美国申请第12/496,446号,2010年4月28日提交的美国申请第12/769,506号和美国专利第6,077,296号中公开的任何支架或假体,这些专利通过引用方式将其整体结合于此。
支架可具有特大型的移植物,该移植物具有不缝合或不以其他方式附接至支架框架的中间部分。在此结构中,可允许该中间部分抵靠血管或通道的内壁扩展以进一步改进移植物和血管壁之间的密封。另外,支架可具有由可高度折叠的、柔性的材料(例如,ePTFE)制成的特大型的移植物,使得,当使支架扩展时,移植物可在密封区域中形成紧闭折叠以减小支架与血管壁之间的泄漏区域的横截面面积。
为了简便,除非另外定义,否则所有上述支架或假体在这里都叫做支架。因此,虽然以下说明和公开内容可能描述支架,并可能示出在特定通道中或身体的区域中的布置,可使用这里公开的任何实施方式,在本领域的普通技术人员的能力内进行或不进行改进,以将任何所需假体布置在身体的任何适当的部分中,是被考虑到的。
图16是导管***100的倾斜视图,该导管***具有与引导器导管组件102对接的递送导管组件104。图17-图19分别是图1的递送导管组件104的倾斜视图、顶视图和侧视图。参考图16至图17,导管***100具有对接装置,其中引导器导管组件102的近端部分可接收递送导管组件104的主体121(在这里也叫做壳体件或壳体轴)的远端部分121a并与之对接。引导器导管102可具有外护套110(在这里也叫做引导器护套),该外护套被引导器导管102的远端部分支撑并从该远端部分延伸。类似地,递送导管组件104具有管状护套127(在这里也叫做递送导管护套),该管状护套从壳体轴121的远端部分121a延伸。护套127可由聚醚醚酮(PEEK)或由任何其他适当的材料制成。
与这种对接装置的特征和部件相关的更多细节,以及与导管***相关的其他细节公布在2008年4月11日提交的名为“BIFURCATEDGRAFTDEPLOYMENTSYSTEMSANDMETHODS”(“分叉移植物布置***和方法”)的美国申请第12/101,863号和2009年7月1日提交的名为“CATHETERSYSTEMANDMETHODSOFUSINGSAME”(“导管***及其使用方法”)的美国申请第12/496,446号中,这两篇专利通过引用方式将其整体结合于此。在这里公开的导管***、递送导管和引导器导管的任何实施方式可具有在以上申请中公开的导管的任何实施方式的任何部件、特征、材料、或其他细节,其组合方式是本公开的一部分。
一个或多个支架可以通过这里公开的导管***100的实施方式被载入、支撑、以及递送。可在递送导管组件104的装配过程中或就在手术过程之前,通过将支架压缩在递送导管组件104的内核件115的外表面周围,一个支架或多个支架可被载入递送导管组件104中。
引导器导管和/或递送导管的可移除约束和/或外护套可将支架保持在压缩状态中。在压缩状态中,支架相对于内芯可被保持在通常固定的轴向位置中,使得内芯的轴向或旋转运动将引起支架的轴向和旋转运动。如将讨论的,内芯可具有例如翅片、珠状部、凸出部、或其他伸出部等特征,,以改进压缩的支架与内芯或内芯线之间的牵引或握持。内芯(连同压缩在其外表面的支架)前进穿过引导器导管中或引导器导管附近的压缩元件,以将支架压缩至从引导器导管伸出的外护套的大约内径的大小。
内芯件115可具有芯线117,该芯线117形成内芯件115的一部分。无创伤的远端119可被支撑在芯线117的远端部分处。内芯件115、芯线117和远端119可包括贯穿其中的连续内腔,该连续内腔被构造为将导丝容纳于其中,使得内芯件115、芯线117和远端119可在导丝上被推进。在支架装载状态下,支架可被折叠或压缩大约内芯线117的至少一部分。
如上所述,导管***构可被造为,使得内芯件115能相对于外护套110轴向地滑动。在此结构中,通过相对于内芯件115收回外护套110,支架可被布置在患者的脉管***的目标区域中,从而暴露出支架。在外护套110对支架提供径向约束的一些实施方式中,当收回外护套110时,暴露出支架将允许自扩展支架抵靠血管壁自扩展。
如将更详细地描述的,这里公开的导管***100的一些实施方式被构造为,使得当用户或外科医生缓慢地操作递送导管组件104并具有第一方式的机械优点时,递送导管可用于从递送导管组件104缓慢且可控地布置支架或支架的一部分。这里公开的导管***的一些实施方式还可被构造为使得,当用户或外科医生通过以第二方式直接拉动调节件而快速地操作递送导管组件104时,递送导管组件104用来从递送导管组件104更快速地布置支架或支架的一部分。
这里公开的导管***可被构造为适应上述布置方式的任何组合。例如,用户或外科医生可以一开始以第一方式操作递送导管以缓慢地从递送导管组件104布置支架,然后,一旦确认了部分布置的支架的适当定位,外科医生便可以第二方式操作递送导管组件104,以快速地布置支架的剩余部分。
参考图16,递送导管组件104的壳体轴121的远端部分121a由凹容纳部分105可移除地且轴向地支撑,所述凹容纳部分被支撑在引导器导管102的近端部分处。引导器导管102在其远端处支撑外护套110,该外护套110限定贯穿其中的内腔,该内腔被构造为在内腔中滑动地容纳内芯件115。内芯件115可滑动地被推进通过递送导管组件104中的开口或内腔、通过引导器导管102中的开口或内腔、并通过外护套110中的内腔。
递送导管组件104具有主体或壳体轴121,该主体或壳体轴具有远端部分121a和近端部分121b。壳体轴121具有通常管状的横截面形状,并沿着壳体轴121的一部分具有外螺纹126(叫做螺纹部分126)。
壳体轴121支撑可滑动的把手件128,该把手件可被构造为,在壳体轴121的远端部分121a与被壳体轴121支撑的可旋转调节件130之间,沿着壳体轴121轴向地滑动。如将描述的,递送导管组件104可被构造为,使得把手件128与内芯件115选择性地接合。当处于接合结构中时,把手件128的运动引起内芯件115的同时且等量的运动。递送导管组件104可被构造为,使得把手件128被防止相对于壳体轴121旋转,从而,防止其相对于引导器导管102和外护套110旋转,以当使把手件128与内芯件115接合时,防止内芯件115的任何不小心的旋转。
螺纹部分126沿着壳体轴121的长度的大约60%延伸。螺纹部分126可沿着壳体轴121的长度的大约40%至大约70%延伸。螺纹部分126可被定位在壳体轴121的近端部分121b附近。螺纹部分126的长度可以是待由导管布置的支架的长度的大约20%到大约200%。例如,如果仅支架的近端部分通过调节件130的旋转被布置,螺纹部分的长度可以是支架的长度的大约20%到大约50%。如在本公开中使用的,术语大约可意味着所述值的正负15%。
可以任何数量的方式防止把手件128的旋转运动。例如,把手件128具有凸出部、伸出部、或类似的可伸入壳体轴121中形成的一个或多个通道或槽中的一个特征或多个特征。如图16中所示,壳体轴121可具有一个单独的槽134,槽134沿着壳体轴121的长度的一部分以线性的方式延伸,槽134被构造为在其中滑动地容纳由把手件128支撑的凸出部、伸出部、或其他类似的特征。
把手件128具有由把手件128支撑的内芯接合组件139。如上所述,递送导管组件104被构造为使得,当内芯件115与把手件128轴向地接合时,把手件128的任何轴向运动将引起内芯件115相对于引导器导管102和外护套110同时轴向运动。压下内芯接合组件139可从把手件128释放内芯件115,使得内芯件115能相对于把手件128轴向地移动。在一些结构中,甚至当内芯件115与把手件128轴向接合时,内芯件115也能相对于把手件128旋转。
如上所述,可旋转调节件130被壳体轴121支撑。使可旋转调节件130与把手件128的螺纹部分126上的外螺纹螺纹接合。在此结构中,在一个方向上旋转或转动可旋转调节件130引起可旋转调节件130沿着螺纹前进,并沿轴向方向朝着壳体轴121的远端部分121a移动。在第二、相反方向上旋转或转动可旋转调节件130引起可旋转调节件130沿轴向方向远离递送导管组件104的壳体轴121的远端部分121a移动。作为可旋转调节件130与壳体轴121之间螺纹接合的结果,可防止可旋转调节件130相对于壳体轴121轴向滑动。因此,把手件128可轴向地滑动,但是被阻止相对于壳体轴121旋转,并且,可旋转调节件130可以旋转,但是被阻止相对于壳体轴121轴向滑动。
在使用中,外科医生可能用一只手(例如,左手)抓住把手件128,并用另一只手抓住可旋转调节件130(最初被轴向地定位在壳体轴的近端130a附近)。外科医生移动内芯件115,以与把手件128接合。为了相对于内芯件115收回引导器导管102的外护套110,外科医生在轴向地收回递送导管组件104的壳体轴121的同时,将把手件128保持在固定位置中,壳体轴121轴向地固定至引导器导管102和外护套110。在内芯接合(和释放)组件139与内芯件115接合的情况下,当外护套110相对于固定至壳体轴121的内芯件115被轴向收回时,将把手件128保持在固定位置可保持内芯件115固定。通过抓住并旋转可旋转调节件130或直接施加拉力以相对于把手件128收回可旋转调节件130,可实现收回递送导管组件104的壳体轴121部分。此步骤引起相对于内芯件115收回外护套110。
当可旋转调节件130轴向邻接把手件128的近端128a时,完成相对于内芯件115更慢递增地收回外护套110。在将把手件128保持在固定轴向位置的同时在第一方向上旋转可旋转调节件130,将缓慢地、递增地且可控地缩回或收回递送导管组件104的壳体轴121,并由此缩回或收回外护套110。在暴露和布置支架的初始布置阶段的过程中,通常执行外护套110的此可控收回,以允许外科医生在将支架定位在目标位置的过程中具有更好的控制和精确性。
总而言之,在此结构中,在把手件128最初定位在壳体轴121的近端部分上的情况下,外科医生通过用一只手将把手件128相对于患者保持在固定位置,同时用他或她的另一只手在第一方向上转动可旋转调节件130以相对于把手件128和内芯件115收回壳体轴121和外护套110,能够可控地收回外护套110以来暴露支架。一旦外科医生确信支架处于所需位置中,那么,外科医生便可通过抓住壳体轴121并相对于把手件128轴向地将其收回,更快速地相对于内芯件115收回外护套110。
如图17至19中所示,递送导管组件104可具有定位于内芯件115上的可选择接合的锁定特征,例如,锁定接合环147。如将要更详细地描述的,接合环147可被构造为与内芯接合组件139可移除地接合。如上所述,当内芯件115与接合组件139接合时,内芯件115被轴向地锁定至接合组件139,从而使得把手件128的轴向运动引起内芯件115的同时轴向运动。甚至当处于锁定或接合位置中时,内芯件115也可相对于接合组件139和把手件128自由旋转。接合环147可被粘接到内芯件115的外表面、或与所述内芯件的外表面一体成形,或以其他方式永久地固定至所述内芯件的外表面。
参考图17-图19,接合环147的一些实施方式可具有锥形表面149和环形沟槽152。锥形表面149可改进使接合环147被推进接合组件139的容易性。下面将描述与这些部件相关的其他细节。
图20是图16的递送导管组件104的倾斜视图,示出了相对于递送导管组件104处于完全或基本完全推进位置中的内芯件115。在此位置中,内芯件115、内芯线117和远端119均被推进经过了递送导管组件104的护套127的端部。当递送导管组件104与引导器导管102接合时,内芯件115、内芯线117和远端119相对于外护套110的端部也被推进,使得由内芯件115支撑的支架将至少部分地(在一些情况中,全部地)暴露。
图21-图23是图16的递送导管的侧视图,示出了分别处于第一预布置位置、第二部分布置位置和第三完全收回位置中的护套,以及递送导管组件104的壳体轴121、把手件128和内芯件115的位置。递送导管组件104被构造为使得把手件128沿着壳体轴121在如图21所示的第一位置与如图23所示的至少第三位置之间滑动。因此,在此结构中,在用户或外科医生可通过使壳体轴121相对于把手件128滑动而收回壳体轴的同时,把手件128保持静止。因此,当把手件128与内芯件115接合时,外科医生可通过使把手件128朝着壳体轴121的远端部分121a滑动,非常快速地相对于递送导管组件104的壳体轴121的远端部分121a推进内芯件115。类似地,如果外科医生希望将内芯件115和假体保持在患者的脉管***内的固定位置中,外科医生或用户可将把手件128保持在固定位置中并轴向地滑动或收回递送导管组件104远离患者的身体,以相对于内芯件115和假体收回引导器导管102的外护套110,从而暴露假体。
可旋转调节件130可与把手件128分离,使得调节件130和壳体轴121可独立于把手件128移动。调节件130包括内螺纹,该内螺纹与壳体轴121的螺纹部分126上的外螺纹接合。当调节件旋转时,在调节件130保持与把手件128接触时,在第一方向上旋转调节件130轴向地收回壳体轴121和护套。调节件130的旋转被用来控制壳体轴121的慢收回的速度,或者施加至调节件的轴向力提供快速收回的选择。
把手件128与内芯件115选择性地接合。图24是内芯接合组件139和内芯件115的倾斜视图,示出了相对于内芯接合组件139处于第一分离位置中的内芯件115,为了清晰起见,从此视图移除了递送导管的其他部件。图25是通过递送导管组件104的轴向中心线的递送导管组件104的一部分的横截面图,示出了相对于内芯接合组件139处于第一分离位置中的内芯件115。图26是和图24中一样的内芯接合组件139和内芯件115的倾斜视图,示出了相对于内芯接合组件处于第二部分接合位置中的内芯。
参考图24-图26,在递送导管组件104的一些实施方式中,接合环147由内芯件115支撑。接合环147具有锥形前表面149以及形成于接合环147的外表面周围的沟槽或凹陷152。前表面149可具有通常截锥形的形状,并且沟槽152可完全环绕接合环147形成以形成环形槽。沿着内芯件115的长度,接合环147可在任何所需位置处被粘接至内芯件115、或与所述内芯件一体成型,或以其他方式固定至所述内芯件或由所述内芯件支撑。
参考图24-图26,接合组件139的本体件155支撑着一个或多个被构造为与接合环147接合的凸出部或臂部159。该一个或多个臂部159可具有被支撑于该一个或多个臂部159的近端159b处的面向内的凸出部或伸出部166。臂部159以悬臂结构由本体件155支撑,以使得该一个或多个臂部159的基部159a被固定至本体件155,并使得该一个或多个臂部159的近端部分159b不被支撑。臂部159由本体件155支撑。
将接合环147构造为,通过使内芯件115在第一(远端)方向上(在图24中,用箭头A1表示)滑动,直到使接合环147与接合组件139接合,而使得接合环147被内芯接合组件139接收。如图26中所图示,当内芯件115和接合环147朝着接合组件139移动时,随着接合环147被推进到接合组件139中,如图26-图28中所示,接合环147的锥形前表面149引起凸出部或臂部163展开。随着内芯件115相对于把手件128的进一步前进,当臂部159的伸出部分166与沟槽152轴向对准时,臂部159的伸出部分166可由于该一个或多个臂部159的偏压,而朝着彼此压缩(弹性地),并进入沟槽152。如图30-图32中所图示,内芯件115与把手件128轴向地接合,直到用户分离接合组件139与接合环147。甚至当与把手件128轴向地接合时,内芯件115也可相对于把手件128自由旋转。
接合组件139还可被构造为,使得该一个或多个臂部159在径向方向上(展开该一个或多个臂部,如图27B中所示)将引起臂部159的伸出部分166被提升远离接合环147的沟槽152。该一个或多个展开的凸出部173由本体部分175支撑,或被构造为在臂部159上施加必要的径向力(展开)以提升伸出部分166,使其远离接合环147。展开的凸出部173可具有锥形形状,使得,相对于该一个或多个臂部159在向下的方向上移动展开的凸出部173可使臂部159向外偏转。按下按钮180可迫使展开的凸出部173向下移动,从而使臂部159向外偏转,以使得接合环147被轴向释放,并被轴向移动而远离接合组件139。
图34是通过递送导管的轴向中心线的递送导管的一部分的横截面图,示出了相对于内芯接合组件139处于分离位置中的内芯件115。
图35是通过递送导管组件104的轴向中心线的递送导管组件104的一部分的横截面图,示出了相对于内芯接合组件139处于接合位置中的内芯件115。如这里所示,偏压机构或弹簧件184由把手件128支撑,并被构造为在第一方向上远离内芯件115偏压按钮180,并由此偏压展开的凸出部175。
此外,参考图34-图35,把手件128具有阻挡件198,其被构造为限制接合环147和内芯件115相对于把手件128的运动范围。例如,阻挡件198的第一端部198a被构造为,当接合环147被推进到把手件128中时,该第一端部邻接抵靠接合环147的前表面149。
支架可被预装在引导器导管组件或引导器护套中,使得在外科手术过程中支架不需要被传送至导管组件或引导器护套中。在一个设备中,递送导管***可具有引导器护套、内芯、以及这里公开的递送导管的部分或所有其他特征。在此包含的设备中,内芯可永久地连接至把手件128,使得不需要将递送导管构造成与内芯选择性接合,从而简化组件并潜在地简化了手术过程。因此,此包含的递送导管组件的一些实施方式,递送导管组件可具有上述导管***100的实施方式的所有部件、特征、细节或结构,其中,内芯接合组件139和内芯件115的锁定接合环147可被内芯件115和把手件128之间的不可选择的接合或其他连接代替。
图36是由递送导管组件104部分布置的假体的图示。图37是举例示出了可用递送导管组件104布置的支架的部分侧视图。图36所示的布置导管可适于布置任何适当的假体,并且不限于图37所示的支架的布置。参考图20、36和37,一个或多个珠状部或凸出部174可形成在芯线117上,或由该芯线支撑。凸出部174可被构造为,当支架被支撑在芯线上的压缩部分中时,增加内芯线117和被芯线117支撑的支架214之间的轴向支撑或连接。另外,凸出部174的尺寸,间隔和结构可被设计为给多个单独的支架段(未示出)提供轴向支撑。例如,多个独立的或束缚的支架段可被定位在管状或分叉的移植物内,并且,所述支架可相对于凸出部174定位,使得凸出部174定位在支架段216之间或定位在顶点、关节,或使支柱互相连接的连接点218之间。
在所示结构中,由芯线117支撑的珠状部或凸出部174可与支柱216接合或与支架214的连接点218接合,以对于保持压缩在外护套110内的支架214的部分,帮助防止支架相对于内芯线117轴向地滑动。此装置在布置支架214的最终阶段的过程中,例如,当仅有支架214的一端部保持被压缩在外护套110内时,如图36中所图示,提供了对于支架214更好的控制。
另外,将凸出部174定位在支柱216或连接点218之间可减小压缩假体、外护套110和包括导管***的其他部件的压缩直径或横截面轮廓。此装置还可允许支撑力在凸出部174、内芯线和支架214之间更均匀的分配。可将凸出部174的尺寸、间隔和结构设计为,以使其被定位在连接部、弯曲部、环圈和/或其他形成于管状或分叉的支架中的连接器附近,例如,包括公开在名为“ENDOLUMINALVASCULARPROSTHESIS”(“腔内血管假体”)的美国专利第6,077,296号中的支架的实施方式的连接部、弯曲部,环圈和/或连接器,该专利通过引用方式将其整体结合于此。
在这里公开的任何导管***实施方式中,导管***可被构造为如这里描述的一样,使得当将支架被装入引导器或引导器护套时,支架可从第一直径或尺寸被压缩至第二直径或尺寸。第一直径或尺寸可以是支架的完全松弛或展开的直径,或者,第一直径或尺寸可以是部分压缩的直径。例如,对于这里公开的一些实施方式,可将支架从第一直径(该第一直径由递送导管的护套限定或控制,或由包围支架的组件设备限定或控制)压缩至第二直径(该第二直径由引导器护套限定或控制)。当前进到引导器中时,支架的缩小比例可以是从大约50%到大约95%,这意味着,第二直径可以是第一直径的大约50%到大约95%。
图38是具有引导器导管组件302的导管***300的侧视图,示出了被装在引导器导管组件302的外护套中的支架。为了清晰起见,仅示出了递送导管304的一部分,并且,引导器导管组件302的某些特征已经被省略。导管***300和/或引导器导管组件302可具有这里公开或结合于此以供参考的导管***或引导器导管组件的任何实施方式的任何部件、特征、材料、或其他细节,结合于此以供参考的申请包括2009年7月1日提交的名为“CATHETERSYSTEMANDMETHODSOFUSINGSAME”(“导管***及其使用方法”)的美国申请12/496,446。此外,引导器导管组件302的实施方式可被构造为,与这里公开或结合于此以供参考的任何递送导管组件的实施方式一起工作。
参考图38,引导器导管组件302可具有主体部分306和支撑于主体部分306的远端306a处的外护套310。引导器导管组件302的内侧上的内孔或开口312可与穿通外护套310形成的开口同轴。引导器导管组件302可具有锥形或弯曲的壁部314,该壁部可被构造为随着支架320穿过引导器导管组件302被推进,将支架320从第一直径“a”压缩至第二直径“b”。其中第二直径“b”等于(引导器)外护套310的内径。
引导器导管组件302和递送导管可被构造为,使得护套316的远端316a终止在主体部分306的压缩部分的前面或大约其附近。在此结构中,支架能够以直径为“a”的松弛或几乎松弛(即,展开)的状态被装入递送导管中,并被引导器导管组件302的锥形壁部314压缩至最终的、压缩直径“b”,从而,在将支架装入引导器导管组件302之前,减小施加至支架的应力。
由递送导管支撑的护套(例如,如上所述的护套316或护套127),可与引导器或外护套310、110的至少近端部分重叠或可被推进到所述近端部分中,或者,使得上述护套316或护套127可以前进通过引导器或外护套310、110的全长。由递穿过通过递送导管护套的远端部分进入引导器或引导器护套时,支架可进一步被压缩。
引导器导管组件302可被构造成用于容纳并布置多种假体中的任何一种,包括不分叉和分叉的支架及支架移植物、支架段、有孔的支架,以及在这里或以其他方式公开的其他类似的支架或支架移植物。引导器导管组件302或这里公开的任何其他引导器导管组件实施方式可被构造成用于容纳和可移除地接合多种递送导管中的任何一种,多种递送导管包括,附属支架导管、肾上腺支架或支架延伸导管、或分叉支架递送导管。
外护套310或这里公开的任何其他外护套实施方式具有大约0.237in的内径和大约0.253in的外径。当用于递送分叉支架时,护套316具有大约0.251in的内径和大约0.263in的外径。当被用于递送附属支架或不分叉支架时,护套316具有大约0.241in的内径和大约0.263in的外径。
当被用于递送分叉支架时,导管***的内芯(图38中未图示出)具有大约0.212in的外径。当被用于递送不分叉支架时,任何导管***的内芯具有大约0.213in的外径。
图39是具有布置导管组件404的导管***400的示意性侧视图,其中布置导管组件404包括内芯408、外护套410、由轴向地附接至内芯408的芯线414支撑的多个凸出部412、以及轴向地附接至芯线414的远端415。支架416被递送导管404支撑,并由外护套410包围。支架416是自扩展分叉支架,如这里图示出的,或者可以是这里公开或结合于此以供参考的任何其他支架或医用假体。递送导管404可进一步包括装在递送导管404中的分支血管线组件417。
图40是在图39的线40-40处得到的分支血管线组件417的横截面图,且图41是由图39的曲线41-41限定的分支血管线组件417的部分的放大示意图。分支血管线组件417包括至少部分地定位于空心管或导丝420内的内线418。分支血管线组件417、内线418或空心管420可具有在2007年1月12日提交的美国申请第11/623,022号中公开的双同心导丝的任何尺寸、特征、材料或其他细节,该专利通过引用方式整体结合于此。
空心管420可穿过支架416的内腔伸出,以使得空心管420的远端420a通过支架416的端部416a伸出。另外,空心管420在支架416的端部附近具有弯曲或扭曲的部分420b。外护套410将空心管420的弯曲部分420b保持在弯曲位置或方向上(第一状态),以将内线418轴向机械连接或锁定至空心管420,直到弯曲部分420b中的弯曲或弯折松弛。如将讨论的,可通过将外护套410缩回或收回得超过空心管420的弯曲部分420b,来松弛弯曲部分420b中的弯曲或弯折,从而允许空心管420和内线418松弛并且变直。因此,当空心管420处于第一状态中时,内线418被轴向地固定至空心管420,使得内线418被轴向地收回,而不会变得与空心管420分离。当外护套410被收回得超过空心管420的弯曲部分420b时,空心管420松弛以使得弯曲部分420b不再被轴向地锁定至内线418。在此第二松弛状态中,内线418可以轴向地被推进至空心管420中,或从所述空心管中被收回。
在此装置中,可用任何适当的跨接技术,内线418可被推进穿过第一分支血管或通道(例如,同侧髂动脉)中的第一穿刺位置,然后,通过第二分支血管或通道(例如,对侧髂动脉)被收回。例如,可使内线通过形成于双腔扩张器中的切开腔中的同侧髂动脉前进。扩张器可被收回或被放置一边,允许内线418通过双腔扩张器的腔中的缝隙,从而使内线418的近端定位在腹主动脉内。在此位置中,内线418可通过对侧髂动脉并通过第二穿刺位置被捕获和收回。
已经结合附图描述了导管***的许多实施方式。对于本领域中的普通技术人员来说将显而易见的是,存在许多可能适合于医疗使用并且在此考虑在内的导管***的潜在的实施方式。例如,这里公开的导管或本领域中可获得的其他导管的一些实施方式的任何部件或特征可以被组合,以形成其他的实施方式,所有这些实施方式都在此考虑在内。
虽然以上描述已经示出、描述并指出了应用于各种实施方式的特征,但可以理解的是,在不背离本公开的精神的前提下,可对所示装置或过程的形式和细节进行各种省略、替代和改变。另外,上述各种特征和工艺能彼此独立地使用,或者能以各种方式组合。所有可能的组合和子组合均落在本公开范围内的。此外,可认识到的是,由于一些特征可能彼此分开地使用或实践,在这里描述的某些实施方式中,可能不会提供这里阐述的所有特征和好处。
Claims (28)
1.一种导管***,包括递送导管,所述递送导管包括:主体、递送导管护套、内芯、把手件以及调节件,其中:
所述主体具有近端部分和远端部分;
所述递送导管护套在远端从所述主体的远端部分伸出;
所述内芯被构造为将支架支撑在其上,所述内芯能轴向地前进穿过所述递送导管的所述主体和所述递送导管护套;
所述把手件由所述递送导管的所述主体支撑,所述递送导管被构造为,使得当所述把手件被连接至所述内芯时,所述把手件和所述内芯在轴向方向上一起移动;以及
所述调节件由所述主体支撑,所述调节件被构造为,使得所述调节件的旋转引起所述调节件沿着所述主体轴向地移动;
其中,当所述调节件被旋转以提供与所述把手件之间的轴向接触力时,通过使所述把手件相对于所述主体轴向滑动,或者通过使所述调节件相对于所述主体旋转,所述把手件能够在所述主体的所述远端部分与所述调节件之间沿着所述递送导管的主体轴向移动。
2.根据权利要求1所述的导管***,其中,所述内芯不可选择地耦接至所述把手件。
3.根据权利要求1所述的导管***,其中,所述内芯能够选择性地与所述把手件接合,并且所述导管***被构造为,使得当所述把手件与所述内芯接合时,所述把手件和所述内芯在轴向方向上一起移动。
4.根据前述权利要求中任一项所述的导管***,其中,所述内芯包括芯线,所述芯线支撑沿着所述内芯的至少一部分轴向隔开的多个凸出部,所述凸出部被定位在所述芯线上以使得在支架装载状态下所述支架与所述凸出部中的一个或多个重叠。
5.根据权利要求4所述的导管***,其中,所述内芯包括芯线和沿着所述芯线的至少一部分轴向隔开的所述多个凸出部。
6.根据权利要求4所述的导管***,其中,所述多个凸出部被构造为在支架装载状态下与所述支架的内骨架接合。
7.根据权利要求5所述的导管***,其中,所述多个凸出部被构造为在支架装载状态下与所述支架的内骨架接合。
8.根据权利要求4所述的导管***,进一步包括引导器导管,所述引导器导管包括主体和从所述主体的远端部分伸出的管状引导器护套,所述引导器导管被构造为,选择性地且可接合地容纳所述递送导管。
9.根据权利要求5-7任意一项所述的导管***,进一步包括引导器导管,所述引导器导管包括主体和从所述主体的远端部分伸出的管状引导器护套,所述引导器导管被构造为,选择性地且可接合地容纳所述递送导管。
10.根据权利要求8所述的导管***,其中,所述引导器护套被构造为,在其中轴向地容纳至少所述内芯。
11.根据权利要求9所述的导管***,其中,所述引导器护套被构造为,在其中轴向地容纳至少所述内芯。
12.根据权利要求8、10和11中任一项所述的导管***,其中,当通过使所述支架穿过所述引导器导管内的锥形通道而使所述支架前进到所述引导器护套中时,支架直径能够减小了5%至50%之间。
13.根据权利要求8、10和11中的任一项所述的导管***,其中,所述引导器护套的内表面的至少一部分由低摩擦涂层覆盖,所述低摩擦涂层包括PTFE、硅树脂、疏水性硅树脂和另外的润滑物质中的至少一种。
14.根据权利要求8、10和11中的任一项所述的导管***,其中,所述引导器导管能够与所述递送导管选择性地接合,以使得当所述递送导管与所述引导器导管接合时,所述引导器导管和所述递送导管中的任一个的轴向运动将引起所述引导器导管和所述递送导管中的另一个的同时且等量的轴向运动。
15.根据权利要求8、10和11中的任一项所述的导管***,其中,所述导管***被构造为,使得当所述引导器导管和所述递送导管接合时,所述递送导管能够相对于所述引导器导管旋转。
16.根据权利要求8、10和11中的任一项所述的导管***,其中,所述导管***被构造为,使得当所述递送导管与所述引导器导管接合时,所述递送导管护套和所述引导器护套不重叠。
17.根据权利要求8、10和11中的任一项所述的导管***,其中,所述导管***被构造为,使得当所述递送导管与所述引导器导管接合时,所述递送导管护套的至少远端部分与所述引导器护套的至少近端部分重叠,或者,所述引导器护套的近端部分与所述递送导管护套的至少远端部分重叠。
18.根据权利要求8、10和11中的任一项所述的导管***,其中,所述导管***被构造为,使得当所述递送导管与所述引导器导管接合时,所述递送导管护套的锥形远端部分前进到所述引导器护套的近端部分中。
19.根据权利要求8、10和11中的任一项所述的导管***,其中,所述递送导管护套的内径比所述引导器护套的内径大。
20.根据权利要求8、10和11中任一项所述的导管***,其中,所述内芯包括芯线,所述芯线支撑沿着所述内芯的至少一部分轴向隔开的多个凸出部,所述凸出部被定位于所述芯线上,使得在支架装载状态下所述支架与所述凸出部中的一个或多个重叠。
21.根据权利要求1-3、5-8、10和11中任一项所述的导管***,其中,所述支架包括移植物,所述移植物在所述移植物的至少远端部分中而非所述移植物的中间部分中被附接至所述支架。
22.一种递送导管***,包括:
主体,具有近端部分和远端部分;
外护套,从所述主体的远端部分伸出;
内芯,被构造为将支架支撑在其上,所述内芯能轴向地前进穿过所述主体和所述外护套;
把手件,由所述主体支撑,所述把手件与所述内芯轴向地耦接,以使得所述把手件和所述内芯在轴向方向上一起移动;以及
调节件,由所述主体支撑,所述调节件被构造为,使得所述调节件的旋转提供这样的机械优点,即,引起所述调节件沿着所述主体轴向地移动;
其中,当所述调节件与所述把手件接触时,通过使所述把手件相对于所述主体轴向地滑动或者通过使所述调节件相对于所述主体旋转,所述把手件能够在所述主体的所述远端部分与所述调节件之间相对于所述主体轴向地移动,从而使所述内芯相对于所述外护套轴向地移动。
23.根据权利要求22所述的导管***,其中,所述内芯不可反转地耦接至所述把手件。
24.根据权利要求22或23所述的导管***,其中,所述内芯包括芯线,所述芯线支撑沿着所述内芯的至少一部分轴向地隔开的多个凸出部,所述凸出部被定位在所述芯线上,使得在支架装载状态下所述支架与所述凸出部中的一个或多个重叠。
25.根据权利要求24所述的导管***,其中,所述内芯包括芯线和沿着所述芯线的至少一部分轴向隔开的所述多个凸出部。
26.根据权利要求24所述的导管***,其中,所述多个凸出部被构造为在支架装载状态下与所述支架的内骨架接合。
27.根据权利要求25所述的导管***,其中,所述多个凸出部被构造为在支架装载状态下与所述支架的内骨架接合。
28.一种递送导管***,包括:主体,具有近端部分和远端部分;外护套,从所述主体的远端部分伸出;内芯,被构造为将支架支撑在其上,所述内芯能轴向地前进穿过所述主体和所述外护套,其特征在于,所述递送导管***还包括:
第一限制件,用于限制所述支架的主体部分;
第二限制件,用于限制所述支架的分支部分;
第一空心释放线,与所述第二限制件轴向地耦接;
第二线,具有近端和远端部分,在支架装载状态下所述第二线前进到所述第一空心释放线中以使得所述空心释放线的至少一部分与所述第二线的远端部分重叠;
其中,形成在所述第一空心释放线中的弯曲部将所述第二线的远端部分能移除地锁定至所述第一空心释放线。
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CN103561807A (zh) | 2014-02-05 |
US20170086998A1 (en) | 2017-03-30 |
EP2680915A1 (en) | 2014-01-08 |
US20140358214A1 (en) | 2014-12-04 |
CN105232195B (zh) | 2018-06-08 |
US20120226341A1 (en) | 2012-09-06 |
US9687374B2 (en) | 2017-06-27 |
CN105232195A (zh) | 2016-01-13 |
US8808350B2 (en) | 2014-08-19 |
US10660775B2 (en) | 2020-05-26 |
WO2012118901A1 (en) | 2012-09-07 |
US20200281751A1 (en) | 2020-09-10 |
US9549835B2 (en) | 2017-01-24 |
US20170304098A1 (en) | 2017-10-26 |
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JP2014514013A (ja) | 2014-06-19 |
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