CN104363862A - 血管假体输送装置及使用方法 - Google Patents
血管假体输送装置及使用方法 Download PDFInfo
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Abstract
一种输送装置,其包括导丝导管和绕导丝导管延伸的输送总成。该输送总成包括将输送总成的近侧柄部与推杆选择性地接合的锁定机构,血管假体直接地或间接地附接至所述推杆。当致动器将近侧柄部从柄体选择性地脱离时,近侧柄部的旋转独立于血管假体相对于柄体的纵向运动,由此近侧柄部可以沿柄体带有旋转地运动。
Description
相关申请
本申请要求于2012年4月12日提交的美国临时申请No.61/623,235的优先权。上述申请的全部教导通过引用合并于此。
背景技术
主动脉瘤是一部分动脉的扩大或膨胀,其可以是危及生命的。主动脉瘤的治疗仍然是一个挑战。腔内修复术已成为替代打开修复主动脉瘤的可行的选择。血管内的治疗方法导致血管内移植物的插入以从血流中逐出动脉瘤囊。一旦到位,血管内移植物展开为血流生成新的路径。血管内移植物通过金属支架的使用永久地保留在主动脉内,该金属支架形成靠在主动脉壁上的紧密配合和密封。目前,血管内输送装置在医生将移植物放置在动脉瘤部位的精确控制上有限制。因此,有必要开发新的和改进的输送装置以及使用输送装置治疗主动脉瘤的方法。
发明内容
本发明整体涉及一种用于植入血管假体的输送装置,以及使用该输送装置的方法。
在一种实施例中,输送装置包括具有近端和远端的导丝导管,并且输送总成绕导丝导管延伸。输送总成包括柄体、输送导管、推杆、近侧柄部以及锁定机构。柄体具有主纵向轴线、近端以及远端。输送导管具有从柄体的远端内绕导丝导管延伸的远端。推杆在输送导管内绕导丝导管延伸。推杆在柄体近侧的导丝导管的近端固定至导丝导管。近侧柄部绕柄体延伸并轴向地固定至输送导管,其中近侧柄部选择性地固定至推杆,并且其中近侧柄部能够绕柄体旋转,并且近侧柄部绕柄体的旋转转化成输送导管和推杆(选择性地)相对于柄体的纵向运动。在柄体处的锁定机构将近侧柄部与推杆选择性地接合。
在一种实施例中,输送装置包括将近侧柄部从柄体选择性地脱离的在近侧柄部处的致动器,由此近侧柄部的旋转是独立于输送导管相对于柄体的纵向运动的。在另一种实施例中,近侧柄部包括限定当近侧柄部绕柄体旋转时相对于柄体的主纵向轴线横向地运动的齿的一端。在这种实施例中,输送装置还包括沿柄体的主纵向轴线延伸的齿条、与近侧柄端的齿接合的联接齿轮(该联接齿轮能够绕与近侧柄部的旋转轴线横向的轴线旋转)以及小齿轮。小齿轮与齿条以及联接齿轮接合,由此近侧柄部绕柄体的旋转转化成输送导管和推杆(选择性地)相对于柄体的纵向运动。致动器将联接齿轮从小齿轮选择性地脱离,从而将近侧柄部的旋转从近侧柄部沿柄体的纵向运动选择性地脱离。
在又一实施例中,输送装置的致动器包括致动器外壳、按钮、小齿轮延伸部分、滚珠轴承以及截头圆锥中心销。致动器外壳绕柄体延伸并可旋转地连接至近侧柄部,由此当近侧柄部绕柄体旋转时,致动器外壳沿柄体是可运动的而不绕柄体旋转。按钮定位于致动器外壳。小齿轮延伸部分限定与小齿轮同轴的同轴开口并限定从同轴开口横向地延伸的至少一个横向开口。滚珠轴承至少部分地位于横向开口内,并且当其位移以径向地延伸越过小齿轮延伸部分时,锁定联接齿轮和小齿轮的相关旋转。截头圆锥中心销从柄体的主纵向轴线径向向外偏置并邻接按钮,由此截头圆锥中心销径向地向外位移滚珠轴承通过横向开口并通过向外偏置锁定联接齿轮和小齿轮的相关旋转,从而当近侧柄部绕柄体旋转时引起近侧柄部沿柄体的纵向运动,并且当按下按钮时,将联接齿轮从小齿轮选择性地脱离,从而将近侧柄部的旋转从近侧柄部沿柄体的纵向运动选择性地脱离。
本发明的输送装置的另一实施例包括在柄体的远端处的远侧把手,并且锁定机构包括转换旋钮、驱动轴、驱动齿轮以及第一锁定组件。转换旋钮定位在远侧把手处并能够绕柄体旋转,并且限定当转换旋钮绕柄体旋转时与柄体的主纵向轴线横向地运动的、沿转换旋钮内侧的齿。锁定机构具有相对于柄体的至少两个固定位置。驱动轴具有近端和远端,其中远端限定与转换旋钮的齿直接地或间接地接合的并沿驱动轴的主纵向轴线延伸的齿。驱动齿轮沿驱动轴并限定与沿驱动轴的齿直接地或间接地接合的齿,由此转换旋钮在转换旋钮的所有位置与驱动齿轮接合。第一锁定组件绕推杆延伸并连接至近侧柄部和驱动齿轮,从而,在转换旋钮的第一位置,第一锁定组件将近侧柄部与推杆接合,并且从第一位置到第二位置的转换旋钮的旋转引起驱动轴的旋转,其接下来引起驱动齿轮的旋转以及第一锁定组件从推杆的脱离,从而当近侧柄部沿柄体的主纵向轴线运动时,允许输送导管沿柄体的纵向轴线相对于推杆的独立运动。
在本发明的另一实施例中,锁定机构还包括第二锁定组件。第二锁定组件绕推杆延伸,固定至柄体,并通过驱动轴连接至转换旋钮,由此转换旋钮从第一位置到第二位置的旋转引起柄体与推杆之间的接合,从而防止当近侧柄部沿主纵向轴线运动时推杆相对于柄体的纵向运动。
在又一实施例中,本发明的输送装置包括尖端输送装置,其包括尖端卡扣总成和近侧卡扣总成。尖端卡扣总成包括在导丝导管的远端的远侧捕捉组件,近侧捕捉组件与远侧捕捉组件是可配合的关系,并且尖端释放导管具有近端,其中尖端释放导管绕导丝导管延伸并固定至近侧捕捉组件。近侧卡扣总成包括在导丝导管的近端处的固定组件以及在尖端释放导管的近端处的外部联结装置,其与近侧卡扣总成的固定组件是可配合的关系,由此外部连接装置相对于固定组件从第一位置到第二位置的运动将会引起近侧捕捉组件相对于尖端卡扣总成的远侧捕捉组件的相关运动。
在又一实施例中,本发明包括输送装置,其包括齿条、柄部(其绕齿条延伸并限定在柄部一端的齿,所述柄部能够绕齿条旋转)、小齿轮(其可绕与柄部的旋转轴线相交的轴线旋转,并与齿条接合)、联接齿轮(其随小齿轮的旋转而选择性地旋转)、致动器(其将小齿轮与联接齿轮选择性地接合)以及固定至柄部的输送导管,从而根据小齿轮通过致动器与联接齿轮的接合,柄部的旋转相对于齿条选择性地运动输送导管。
在又一实施例中,本发明为用于将血管假体输送至患者的治疗部位的方法。该方法包括,当假体的近端安装到固定至导丝导管的远端的输送装置时,将血管假体推进至患者的血管治疗部位远侧的位置。近侧柄部绕输送装置的具有远端的柄体以第一方向旋转,导丝导管通过所述柄体延伸。导丝导管设置在也延伸穿过柄体的推杆内,其中导丝导管固定至推杆,由此近侧柄部的旋转引起导丝导管和推杆沿柄体的纵向运动,从而将假体至少部分地推进至治疗部位,假体在从柄体的远端绕假体延伸的外部导管内推进。第一锁定组件将近侧柄部固定至推杆的位置从第一位置转换到第二位置,其中第一锁定组件将近侧柄部从推杆脱离,并且第二锁定组件将推杆与柄体接合。然后近侧柄部以第二方向旋转,由此具有远端的并且绕推杆延伸的输送导管沿推杆撤回,并且从输送导管的远端延伸的输送护套至少部分地从假体缩回。然后假体的近端从尖端输送装置释放。第二锁定组件转换以将推杆从柄体脱离,并且推杆和导丝导管从假体内撤回,从而将血管假体输送至治疗部位。
本发明的输送装置及其使用方法具有很多优点。例如,在治疗部位的植入期间,近侧柄部的旋转从而推进推杆和在推杆端部的血管假体为血管假体的运动提供了增加的控制。另外,近侧柄部和推杆的选择性的接合能够实现近侧柄部从推杆的脱离,从而通过近侧柄部的与将血管假体推进至治疗部位所使用的相反的方向的旋转,提供输送护套从血管假体的控制的缩回。此外,输送装置的致动器能够实现近侧柄部从柄体的选择性的脱离,由此近侧柄部可在不旋转的情况下沿柄体运动,从而在血管假体到治疗部位的推送期间和在假体已被推进至治疗部位且输送护套从假体的缩回期间,提供血管假体的运动的另外的自由度。本发明的输送装置还具有这样的优点,根据近侧柄部从推杆的脱离引起推杆与柄体的接合,从而在输送护套通过近侧柄部的运动正在从血管假体缩回时,能够实现输送护套从血管假体的撤回而没有血管假体的夹带。另外,尖端输送装置在推杆和导丝导管的近端处是可控制的,从而在输送装置的剩余组件维持静止时,能够实现血管假体的近端在治疗部位处的选择性的释放。此外,推杆可从柄体和近侧柄部脱离,从而能够实现一旦血管假体在输送装置处被植入,推杆、导丝导管以及尖端输送装置从血管假体内的缩回,从而最小化一旦血管假体被植入,血管假体潜在的破坏。
附图说明
图1为本发明的输送装置的一种实施例的透视图。
图2为本发明的转换旋钮、驱动轴以及致动器的一种实施例的透视图。
图3为图2中所示的转换旋钮和驱动轴的透视图。
图4为本发明的另一实施例的转换旋钮、远侧柄部、远侧柄部鼻部的透视图,以及柄体和输送导管的部分横截面视图。
图5为图4中所示的本发明的输送装置的实施例的一部分的局部剖面图。
图6为柄体、中间齿轮、减速齿轮以及连接齿轮的一部分的细节的局部剖面图,所有这些将转换旋钮与图4中所示的本发明的实施例的驱动轴连接。
图7为图4的实施例的局部剖面图,示出了远侧柄部以及在远侧柄部鼻部处的基座(外部导管连接至其上)的横截面视图。
图8为图4的实施例的局部剖面图,示出了绕输送导管延伸的约束环。
图9为图1的输送装置的另一实施例的局部剖面图,示出了在由柄体限定的狭槽的近端处的致动器和按钮。
图10为图1中所示的实施例的第一锁定组件、第二锁定组件以及它们与驱动轴的关系的透视图。
图11为第一锁定组件与第二锁定组件,以及稳固第一锁定组件与第二锁定组件之间各自关于图1的实施例的驱动轴的空间关系的第一锁定组件外壳与第二锁定组件外壳的另一种表示。
图12A为图1的实施例的另一透视图,示出了近侧柄部和致动器沿柄体的位移,其是由于近侧柄部绕柄体的旋转,或者是由于致动器的按钮的按压从而允许在近侧柄部不旋转的情况下致动器和近侧柄部的纵向运动。
图12B为图1的实施例的另一透视图,其中近侧柄部已沿输送系统的柄体推送。
图13为在图1所示的本发明的实施例的柄体处的近侧柄部和致动器的细节,此时不带有致动器外壳。
图14为图13的细节的透视图,不带有图13中所示的致动器的按钮。
图15为图1的实施例的局部剖面图,示出了小齿轮总成和联接齿轮总成相对于第一锁定组件外壳的关系,以及第一锁定组件外壳与在外壳内的输送导管的关系。
图16为柄体的剖面图内的第一锁定组件外壳和第二锁定组件外壳的透视图,连同致动器的联接齿轮总成和小齿轮总成的透视图。
图17为图16中所示的本发明的表示的侧视图。
图18为图16和图17中所示的柄体的远端和第二锁定组件的局部剖面图。
图19为图17中所示的致动器的局部剖面的透视图。
图20为图1中所示的实施例的齿条和近侧柄部的透视图,以及在缺少联接齿轮总成时本发明的致动器的替代实施例。
图21为图20的小齿轮总成的实施例的部分透明的透视图。
图22为图21中所示的实施例的另一视图。
图23为缺少图21和图22中所示的上部小齿轮时这些图中所示的实施例的透视图。
图24为图23中所示的表示的另一实施例。
图25为本发明的一种实施例的近侧卡扣总成的一种实施例的透视图。
图26为图25中所示的近侧卡扣总成的局部剖面图。
图27A-27C为图1中所示的输送装置的远端的剖面透视图。
图28A为处于第一位置的转换旋钮的透视图,其中推杆固定至近侧柄部并且未部署假体。
图28B为处于第一位置的近侧卡扣总成的详细透视图,由此,尖端卡扣总成是未打开的。
图28C为处于第一位置的转换旋钮的详细透视图。
图29A为图28A-28C的输送装置的透视图,示出了当转换旋钮处于第二位置时,含有假体的输送护套的前进,其中推杆固定至柄体。
图29B为图29A的输送护套的前进的详细透视图。
图30A为示出了输送护套的前进的图29A、29B的输送装置的透视图。
图30B为处于第二位置的图30A的转换旋钮的详细透视图。
图31A为图30A、30B的输送装置的透视图,其中输送护套已经部分地从假体缩回。
图31B为处于关闭位置的本发明的一种实施例的尖端卡扣总成的表示。
图32A为图31A的输送装置的透视图,其中尖端卡扣总成由近侧卡扣总成的致动打开,从而释放图32C中所示的假体的近侧支架的尖端。
图32B为图25、26的近侧卡扣总成的表示,借以尖端卡扣总成(未示出)已经打开。
图32C为处于打开位置的本发明的一种实施例的尖端卡扣总成的表示。
图33A为图32A的输送装置的透视图,其中转换旋钮已经运动至第三位置,借以推杆已经从近侧柄部和柄体释放,并且其中推杆已经从完全部署的假体缩回。
图33B为如图33A所示的处于第三位置的转换旋钮的透视图。
具体实施方式
虽然本发明已参考其示例性实施例具体地示出和描述,本领域的技术人员可以理解,在其中可做出的形式和细节上的各种改变都不脱离由所附权利要求书所包含的本发明的范围。
图1示出了本发明的输送装置10的一种实施例。输送装置10包括具有近端和远端的导丝导管12(图10、11)。本文所使用的关于输送装置及其组件的术语“近侧”的意思是相对地接近操作输送装置的医生。本文所使用的关于输送装置及其组件的术语“远侧”的意思是相对地远离操作输送装置的医生。本文所使用的关于假体、支架移植物以及组件的术语“近侧”的意思是相对地接近患者的心脏。本文所使用的关于假体、支架移植物以及组件的术语“远侧”的意思是相对地远离患者的心脏。回到图1,输送装置10包括绕导丝导管(未示出)延伸的输送总成18。输送总成18包括具有主纵向轴线22、近端24以及远端26的柄体20。输送导管28(图9)具有远端30(图27A),其从柄体20的远端26内绕导丝导管(未示出)延伸。推杆32在导丝导管28内绕导丝导管12延伸(图10、11)。推杆32在销192(图25)处在柄体近侧的推杆32的近端34处固定至导丝导管12。回来参照图1,近侧柄部36绕柄体20延伸并轴向地固定至输送导管28。近侧柄部36选择性地固定至推杆32,其中,如通过比较图12A与图12B可以看到,近侧柄部36能够绕柄体20旋转,并且近侧柄部36绕柄体20的旋转转化成输送导管28沿纵向轴线22和推杆32(选择性地)相对于柄体20的纵向运动。在柄体20处的第一锁定机构38(图15)将近侧柄部36(图12A和12B)与推杆32选择性地接合。
远侧柄部40在柄体20的远端26处绕柄体20延伸,并且在第一锁定机构38(图15)的转换旋钮42的远侧。远侧柄部鼻部44(图1)从远侧柄部40远侧地延伸并且包括用于在溶液源(未示出)与输送装置10的内部组件之间提供流体连通的冲洗孔46,如必要,以在患者中的血管假体的植入期间,水化输送装置10的组件与患者内的血管假体(未示出)之间的接触。外部导管48从远侧柄部鼻部44(图1)延伸。
致动器80连接至近侧柄部36,由此当致动器80的在外壳81处的按钮82维持对准柄体20限定的狭槽84时,近侧柄部36可绕柄体20旋转。致动器80的按钮82的按压将近侧柄部36从柄体20选择性地脱离,由此近侧柄部20的旋转独立于输送导管12沿纵向轴线22相对于柄体20的纵向运动。
从图2中可以看到,转换旋钮42通过驱动轴88连接至驱动齿轮86。驱动轴88具有近端90和远端92,并且沿柄体20(未示出)的内部行进。从图3中可以看到,在一种实施例中,转换旋钮42通过中间齿轮94A连接至驱动轴88,由此转换旋钮42绕柄体20的旋转凭借转换旋钮42与驱动轴88之间通过中间齿轮94A的联接,引起驱动轴88的旋转。在这种实施例中,转换旋钮42间接地连接至驱动轴88,与直接联接相反。“直接联接”是彼此直接接触。如图1所示,转换旋钮42可旋转地连接至远侧柄部40,其固定至柄体20的远端26。
如图4和图5所示,在另一实施例中,转换旋钮42与驱动轴88之间的联接包括在中间齿轮94B处连接至同轴减速齿轮96的齿轮减速,接着,同轴减速齿轮96连接至同轴地连接至驱动轴88的连接齿轮98。利用减速齿轮,转换旋钮42相对于驱动轴88的旋转速率可由减速齿轮96和连接齿轮98的相对尺寸控制(图5、6、7)。典型地,转换旋钮42:驱动轴88的旋转比或减速比为约1:2与约1:6之间的比率。从图6中可以更详细地看出减速齿轮96与连接齿轮98之间的关系。
从图7中可以更详细地看出,输送导管28延伸穿过柄体20、远侧柄部40以及远侧柄部鼻部44。回来参考图5,外部导管48连接至基座102,由此外部导管48可独立于柄体20旋转。如图8中所示,约束环104沿在柄体20内的输送导管28延伸。如图8和图9所示,约束环104具有大于狭槽84宽度的外径,由此约束环104会防止近侧柄部36将纵向压缩力施加在输送导管28上而引起输送导管28弯曲或从而运动通过狭槽84来到柄体20外面。约束环104还具有比输送导管28的外径稍小的内径,由此约束环104与输送导管28会具有过盈配合,使得约束环104在被引导的情况下可沿输送导管28纵向地运动,而在其它情况下则相对于输送导管28保持就位。齿条106在柄体20内纵向地延伸。在柄体20的远端处的销108从柄体20的远端26延伸,并且选择性地位于转换旋钮42的狭槽110、112、114内。转换旋钮42可沿柄体20充分地纵向运动并可绕柄体20充分地旋转,以允许转换旋钮42运动销108在转换旋钮42的任何狭槽110、112、114内的放置,从而引起中间齿轮94的旋转。因此,驱动轴88绕驱动轴88的纵向轴线116旋转。转换旋钮42通过弹簧118(图7)偏倚在销108上。
从图9中可以看到,齿条106和驱动轴88延伸狭槽84的长度。图10示出了驱动轴88、推杆32以及第一锁定机构38之间的关系。推杆32延伸穿过第一锁定机构38,接着第一锁定机构38在第一锁定机构38的驱动齿轮86处与驱动轴88接合。第一锁定机构38在远侧轴承120处相对于近侧柄部(未示出)是固定的,推杆32延伸穿过远侧轴承120。远侧轴承120由销122连接至第一锁定组件外壳150。第一锁定机构38的第一锁定组件124在远端126处相对于远侧轴承120是固定的并且在近端128连接至驱动齿轮86,由此驱动轴88的旋转以及随之发生的驱动齿轮86的旋转会进一步盘绕第一锁定组件124、或减少盘绕第一锁定组件124,因此,造成推杆32分别与锁定机构38和因此与近侧柄部(未示出)接合或脱离。如通过比较图12A和12B可以看到,当第一锁定机构38与推杆32接合时,近侧柄部(未示出)沿驱动轴88和柄体20的纵向运动会引起推杆32沿驱动轴88和柄体20的纵向运动。
回来参考图10、11,驱动轴88在驱动轴轴承130处可旋转地固定至柄体20(图9),驱动轴轴承130是在驱动轴88的近端90处的第二近侧锁定组件外壳152的一部分。第二锁定机构132包括变换齿轮134,变换齿轮134在驱动轴88的近端90处与驱动轴88接合并且与机构轴承136(图11)可旋转地接合,机构轴承136包括近侧轴承138(图10)和远侧轴承140(图10),接着机构轴承136在销142处相对于柄体20固定。近侧轴承138径向地和轴向地固定至柄体20。远侧轴承140轴向地固定至柄体20。第二锁定机构132的第二锁定组件144在第二锁定组件144的近端146处与近侧轴承138之一接合,并且在第二锁定组件144的远端148处与变换齿轮134接合,由此驱动轴88的旋转和随之发生的变换齿轮134的旋转会使第二锁定组件144变紧并使其与推杆32接合,或使第二锁定组件144变松并使其与推杆32脱离。当与推杆32接合时,第二锁定组件144使推杆32相对于柄体(未示出)固定在位置上。当变松并从推杆32脱离时,推杆32能够相对于柄体(未示出)纵向运动。第一锁定组件124与第二锁定组件144的定向是相反的,由此驱动轴88在一个方向的旋转会同时地引起第一锁定组件124和第二锁定组件144与推杆32的相应的接合和脱离。第一锁定组件124从推杆32的脱离是由转换旋钮42从第一位置(在转换旋钮42的狭槽110处由销108限定)到第二位置112(在转换旋钮42(图9)的狭槽112处由销108限定)的运动引起的。从转换旋钮42的第一位置到第二位置的同样的运动会同时地引起第二锁定组件144与推杆32的接合,由此不管近侧柄部36沿柄体20的纵向轴线116的运动,推杆32将相对于柄体20在第二锁定组件144处固定就位。回来参考图8和图9,定位转换旋钮42,使得销108处于转换旋钮42的第一狭槽110与第二狭槽112之间的中间狭槽114处,将会使第一锁定组件124和第二锁定组件144二者从推杆32脱离。
从图11中可以看到,相应地,第一锁定组件外壳150固定第一锁定组件124和驱动轴88的横向运动,并且第二锁定组件外壳152固定第二锁定组件144和轴承138、140相对于驱动轴88的近端90的位置。另外,也可从图11中看到,尖端释放导管154在推杆32内延伸并且导丝导管12在尖端释放导管154内延伸。
图12A和12B标示了致动器80和近侧柄部36沿柄体20的相对运动。如图12A和12B所示,当按钮82处于第一位置时,近侧柄部36绕柄体20的旋转将会引起近侧柄部36和致动器80沿柄体20的纵向运动。根据按钮82至基本与致动器外壳81平齐的第二位置的按压,近侧柄部36的旋转将不会引起近侧柄部36或致动器沿柄体20的纵向运动。更确切地说,在近侧柄部36不绕柄体20旋转的情况下,近侧柄部36和致动器80能够沿柄体20运动。
从图13-15中可以看到,近侧柄部36的齿156与联接齿轮总成158的上部联接齿轮160接合。联接齿轮总成158与小齿轮总成164接合。联接齿轮总成158的下部联接齿轮162与小齿轮总成164的上部小齿轮166接合。小齿轮总成164通过狭槽84连接至第一锁定组件外壳150(图11)。相对参照图1,联接齿轮总成158和小齿轮总成164为致动器80的组件。图16为图1(不带有外壳81或按钮82)的致动器80、第一锁定组件外壳150以及第二锁定组件外壳152的透视图。
从图17中可以看到,上部小齿轮166与下部小齿轮168同轴,接着下部小齿轮168与齿条106接合。回来参考图16和17,输送导管28连接至第一锁定组件外壳150,并从而将通过如图1中所示的近侧柄部36和致动器80的运动而沿外壳150纵向地运动,无论第一锁定组件124是否与推杆32接合。因此,当上部小齿轮166与下部小齿轮168接合时,近侧柄部36(如图1所示)绕柄体20的旋转将引起联接齿轮总成158(图13)的旋转,并且从而引起小齿轮总成164(图13)的旋转和小齿轮总成164(图13)沿齿条106(图16和17)的运动,以及近侧柄部36(图1)和致动器80(图17)沿柄体20的运动。另外,当第一锁定组件124与推杆32接合时,近侧柄部36的旋转将引起推杆32沿柄体20的纵向运动。在所有情况下,近侧柄部36和致动器80沿柄体20的运动将总是一起发生,并且将引起输送导管28沿柄体20的纵向运动。
然而,如下面将进一步说明的,中心销170的下压将上部小齿轮166从下部小齿轮168脱离。当上部小齿轮166从下部小齿轮168脱离时,近侧柄部36绕柄体20的旋转不会引起近侧柄部36和致动器80沿柄体20的纵向运动。另外,近侧柄部36和致动器80沿柄体20的纵向运动可简单地通过沿柄体20运动近侧柄部36和致动器80而不需要近侧柄部36绕柄体20旋转获得(图1、12A和12B)。
图18示出了在柄体20的近端24内的第二锁定组件外壳152和在轴承138、140之间延伸的第二锁定组件144的布置。如上面描述的,凭借驱动轴88的旋转的变换齿轮134的旋转(图10、11)将引起第二锁定组件144与延伸穿过第二锁定组件144的推杆32之间的接合和脱离,并且从而引起推杆32与柄体20的近端24的接合和脱离。
图19为致动器80(图1)的联接齿轮总成158和小齿轮总成164的另一透视图。
如图20中所示的可替代实施例,按钮82位于中心销170顶部,其延伸穿过上部小齿轮166。从图20和21中可以看到,下部小齿轮168与齿条106接合并且包括小齿轮延伸部分169,小齿轮延伸部分169轴向地对准与上部小齿轮166轴向地对准的下部小齿轮168。小齿轮168的下部部分172延伸进入由第一锁定组件外壳150(图11)限定的开口174(图11),从而固定小齿轮总成164相对于第一锁定组件外壳150(图11)、远侧轴承120(图11)、第一锁定组件124以及驱动齿轮86的位置,所有这些在之前的实施例中示出在图11中。
图21为示出了下部小齿轮168与齿条106的接合和中心销170的截头圆锥部分176的透视图。从图22和23中可以看到,滚珠轴承178延伸穿过由小齿轮延伸部分169限定的开口180,并且当中心销170处于延伸位置时,如图22所示,中心销170的截头圆锥部分176向外地推动滚珠轴承178并与由上部小齿轮166(图21和22)限定的开口182(图21)成为干涉关系,从而使上部小齿轮166与下部小齿轮168接合。如图23所示,当中心销170通过下压按钮82(图1)致动时,滚珠轴承178被上部小齿轮166(图22)相对于下部小齿轮168(图22)的旋转向内推动,由此上部小齿轮166不再与下部小齿轮168接合。中心销170被偏置于向外的位置,由此上部小齿轮166被定位于中心销170基座的弹簧184引导与下部小齿轮168接合(图22或23中未示出)。
从如32C中可以看到,鼻锥50固定至位于导丝导管12的远端16处的导丝导管12。血管假体组件58在鼻锥50近侧设置在输送装置10内(图27A)。
图25和26相应地示出了本发明的近侧卡扣总成184组件的透视图和剖视图。从图25中可以看到,外部联结装置186能够沿推杆32的近端34滑动。固定组件188通过销192固定至导丝导管的近端。外部联结装置186和固定组件188在接缝190处为匹配关系。外部联结装置186内的弹簧194将外部联结装置186偏靠在固定组件188上。近侧卡扣总成184从如图25、28B所示的第一位置运动至第二位置,示出了通过向外部联结装置186两侧的舌196施加压力并向远侧引导外部联结装置186足够的程度,以允许外部联结装置186旋转九十(90)度并接着缩回外部联结装置186,使得外部联结装置186的舌196在固定组件188的舌198之间对准,如图32B所示。外部联结装置186的从图25所示的第一位置到图32B所示的位置的运动使尖端卡扣总成52打开,由此近侧捕捉组件从与图31B所示的尖端卡扣总成52的远侧捕捉组件56相匹配的第一位置缩回至图32C所示的第二位置,其中近侧捕捉组件54与远侧捕捉组件56不再是匹配关系。近侧卡扣总成184的外部联结装置186相对于固定组件188的近侧运动(图25、28B、32B)将近侧捕捉组件54(图31B)从远侧捕捉组件56(图31B、32C)分离,释放位于血管假体组件58的近端60处的支架66的尖端68。
图27A-27C为本发明的输送装置10的一部分的横截面视图,示出了在输送装置10的远端202内的处于未部署状态的血管假体组件58。具体地,如图27A所示,血管假体组件58在输送护套200内。血管假体组件58的远端62邻接扶壁204。接着,扶壁204匹配至位于远端206的推杆32,如图27A所示,当尖端卡扣总成52处于关闭位置时,血管假体组件58的近端60通过尖端卡扣总成52被捕捉在近侧支架66的尖端68处。尖端卡扣总成52包括位于导丝导管12的远端16处的远侧捕捉组件56,并且近侧捕捉组件54与远侧捕捉组件56成匹配关系,并附接至尖端释放导管154的远端210。尖端释放导管154绕导丝导管12延伸,并且尖端释放导管154和导丝导管12都延伸经过血管假体组件58和推杆32至近侧卡扣总成184(图26)。从图27C中可以看到,输送护套200在其近端处固定至输送导管28的远端30并绕血管假体组件58延伸至尖端卡扣总成52。回到图27,鼻锥50在尖端卡扣总成52的远侧捕捉组件56远侧固定在导丝导管12处。外部导管48从远侧柄部鼻部44(图1)绕输送导管28和输送护套200延伸至鼻锥50。
如图28A-33B所示,一种用于使用本发明的输送装置将血管假体输送至患者的治疗部位的方法包括,当假体58在假体58的近端60处安装至尖端卡扣总成52时,推进血管假体58。如图28B所示,近侧尖端卡扣总成184处于第一位置,由此尖端卡扣总成52是关闭的(图31B)。当近侧卡扣总成184位于第一位置时,血管假体58的尖端固定在尖端卡扣总成52。接着,尖端卡扣总成52固定至导丝导管12的远端16,当销108在狭槽110中时转换旋钮42位于第一位置(图28C),使推杆32随着近侧柄部36的纵向运动而运动。假体58被近侧柄部36绕输送装置10的柄体20(具有远端26)沿第一方向的旋转推进至在患者血管治疗部位远侧的位置,导丝导管12延伸穿过所述输送装置10。导丝导管12设置在也延伸穿过柄体20的推杆32内,其中导丝导管12在诸如导丝导管12或推杆32的远端处被销192固定至推杆32(图25),可从图29A-29B看到,由此近侧柄部36的旋转引起导丝导管12和推杆32沿柄体20的纵向运动,从而至少部分地从外部导管48推进假体58。可选择地,致动器80的按钮82可被按下以将近侧柄部36的旋转从近侧柄部36沿柄体20的纵向运动脱离,从而允许血管假体58到患者血管治疗部位的人工推进而不需要近侧柄部36绕柄体20的旋转。
转换旋钮42从第一位置(其中第一锁定组件124(图10、11)将近侧柄部36固定至推杆32)转换至第二位置(由此第一锁定组件124(图10、11)将近侧柄部36从推杆32脱离并且第二锁定组件144(图10、11)将推杆32与柄体20在柄体20的近端24处接合)。
从图31A和31B中可以看到,当致动器按钮82没有被按下时,近侧柄部36可以第二方向旋转,由此具有远端30(图24A)并绕推杆32延伸的输送导管28沿推杆32撤回,并且从输送导管(图4-9)的远端延伸的输送护套200至少从假体52附近部分地缩回。可选择地,致动器80的按钮82可被按下,从而将近侧柄部36的旋转从柄体20脱离,从而将输送护套200从血管假体58完全地缩回而不需要近侧柄部36绕柄体20的旋转,如图32A所示。
接着,近侧卡扣总成184由以下致动:首先按压外部联结装置186并远侧地运动外部联结装置186,接着将外部联结装置186旋转九十度,并且在这之后将外部联结装置186缩回至第二位置,如图32B所示,从而将尖端释放导管154缩回推杆32(图10、11)内并且将近侧捕捉组件54从远侧捕获组件56缩回。从图32C可以看到,在血管假体58的近端60处的支架66的尖端68从尖端卡扣总成52释放,并且从而假体58从输送装置10释放。接着,从图33B可以看到,转换旋钮42从第二位置运动至第三位置,其中销108定位在第一狭槽110与第二狭槽112之间的狭槽114中,从而将推杆32从柄体20脱离。接着,从图33A可以看到,推杆32和导丝导管12通过拉动推杆32穿过柄体20从血管假体58撤回,从而完成血管假体58到治疗部位的输送。
虽然本发明已参考其示例性实施例进行了具体地示出和描述,但本领域中的技术人员可以理解,这里可做出的形式和细节上的各种改变都不脱离所附权利要求书所包括的本发明的范围。
本文引用的所有参考文献和美国专利No.8,070,790和美国专利申请No.12/459,387(公开号No.20100030255)和No.12/723,431(公开号No.20100234932)的相关部分通过引用整体合并于此。
Claims (30)
1.一种输送装置,其包括:
a)导丝导管,其具有近端和远端;以及
b)输送总成,其绕导丝导管延伸,其包括:
i)柄体,其具有主纵向轴线、近端和远端,
ii)输送导管,其具有从柄体的远端内绕导丝导管延伸的远端,
iii)推杆,其在输送导管内绕导丝导管延伸,该推杆在柄体近侧的导丝导管的近端处固定至导丝导管,
iv)近侧柄部,其绕柄体延伸并且轴向地固定至输送导管,近侧柄部选择性地固定至推杆,其中近侧柄部能够绕柄体旋转,并且近侧柄部绕柄体的旋转转化成输送导管和选择性地推杆相对于柄体的纵向运动,以及
v)在柄体处的锁定机构,其将近侧柄部与推杆选择性地接合。
2.根据权利要求1所述的输送装置,还包括在近侧柄部的致动器,其将近侧柄部从柄体选择性地脱离,由此近侧柄部的旋转独立于输送导管相对于柄体的纵向运动。
3.根据权利要求2所述的输送装置,其中,近侧柄部包括限定齿的一端,齿在近侧柄部绕柄体旋转时与柄体的主纵向轴线横向地运动,其还包括,
a)齿条,其沿柄体的主纵向轴线延伸;
b)联接齿轮,其与近侧柄端的齿接合,该联接齿轮能够绕横向于近侧柄部的旋转轴线的轴线旋转;以及
c)小齿轮,其将齿条与联接齿轮接合,由此近侧柄部绕柄体的旋转转化成输送导管和选择性地推杆相对于柄体的纵向运动,使得致动器将联接齿轮从小齿轮选择性地脱离,从而将近侧柄部的旋转从近侧柄部沿柄体的纵向运动选择性地脱离。
4.根据权利要求3所述的输送装置,其中致动器包括:
a)致动器外壳,其绕柄体延伸并且能够旋转地连接至近侧柄部,由此当近侧柄部绕柄体旋转时,致动器外壳能够沿柄体运动而不绕柄体旋转;
b)按钮,其位于致动器外壳处;
c)小齿轮延伸部分,其限定与小齿轮同轴的同轴开口,并且限定从该同轴开口横向地延伸的至少一个横向开口;
d)滚珠轴承,其至少部分地位于横向开口内,并且当其位移以径向地延伸越过小齿轮延伸部分时锁定联接齿轮与小齿轮的相对旋转;以及
e)截头圆锥中心销,其从柄体的主纵向轴线径向地向外偏置并且邻接按钮,由此截头圆锥中心销将滚珠轴承径向地向外位移穿过横向开口并通过向外偏置锁定联接齿轮与小齿轮的相对旋转,从而当近侧柄部绕柄体旋转时,引起近侧柄部沿柄体的纵向运动,并且当按钮被按下时,将联接齿轮从小齿轮选择性地脱离,从而将近侧柄部的旋转从近侧柄部沿柄体的纵向运动选择性地脱离。
5.根据权利要求4所述的输送装置,其中,还包括在柄体的远端的远侧把手,并且其中锁定机构包括:
a)位于远侧把手处的转换旋钮,其能够绕柄体旋转并限定沿转换旋钮内侧的齿,当所述转换旋钮绕柄体旋转时齿与柄体的主纵向轴线横向地运动,并且其中锁定机构具有相对于柄体的至少两个固定位置;
b)驱动轴,其具有近端和远端,其中远端限定与转换旋钮的齿接合并沿驱动轴的主纵向轴线延伸的齿;
c)沿驱动轴的驱动齿轮,其限定与沿驱动轴的齿接合的齿,由此转换旋钮在转换旋钮的所有位置与驱动齿轮接合;以及
d)第一锁定组件,其绕推杆延伸,该锁定组件连接至近侧柄部和驱动齿轮,由此,在转换旋钮的第一位置,第一锁定组件将近侧柄部与推杆接合,并且转换旋钮从第一位置到第二位置的旋转引起驱动轴的旋转,接着,驱动轴的旋转引起驱动齿轮的旋转和第一锁定组件从推杆的脱离,从而当近侧柄部沿柄体的主纵向轴线运动时,允许输送导管沿柄体的主纵向轴线相对于推杆的独立运动。
6.根据权利要求5所述的输送装置,其中,锁定机构还包括第二锁定组件,该第二锁定组件绕推杆延伸,固定至柄体并通过驱动轴连接至转换旋钮,由此转换旋钮从第一位置到第二位置的旋转引起柄体与推杆之间的接合,从而当近侧柄部沿主纵向轴线运动时防止推杆相对于柄体的纵向运动。
7.根据权利要求6所述的输送装置,还包括尖端输送装置,其包括:
a)尖端卡扣总成,其具有:
i)远侧捕捉组件,其位于导丝导管的远端,
ii)近侧捕捉组件,其能够与远侧捕捉组件为匹配关系,以及
iii)尖端释放导管,其具有近端,该尖端释放导管绕导丝导管延伸并固定至近侧捕捉组件,以及
b)近侧卡扣总成,其具有,
i)固定组件,其位于导丝导管的近端,以及
ii)外部联结装置,其位于尖端释放导管的近端并且能够与近侧卡扣总成的固定组件为匹配关系,由此外部联结装置相对于固定组件的从第一位置到第二位置的运动将引起近侧捕捉组件相对于尖端卡扣总成的远侧捕捉组件的相对运动。
8.根据权利要求7所述的输送装置,其中,转换旋钮包括第三位置,其中,第一锁定组件和第二锁定组件从推杆脱离,由此推杆能够通过推杆的纵向运动相对于柄体和近侧柄部纵向地运动,从而独立于近侧柄部和柄体运动导丝导管。
9.根据权利要求8所述的输送装置,其中,推杆能够径向地旋转。
10.根据权利要求8所述的输送装置,其中,柄体限定致动器所延伸穿过的狭槽,其还包括绕柄体内的输送导管延伸的多个约束环,该约束环具有比狭槽的外径大的外径,由此约束环将防止由于近侧柄部将纵向压缩力施加在输送导管上而引起输送导管弯曲并从而运动穿过狭槽来到柄体外面。
11.根据权利要求10所述的输送装置,其中,约束环限定小于输送导管外径的内径,从而在它们之间形成过盈配合,并由此约束环能够沿输送导管纵向地运动。
12.根据权利要求10所述的输送装置,还包括外部导管,其固定至柄体的远端并从柄体的远端延伸。
13.根据权利要求12所述的输送装置,其中,外部导管能够相对于柄体旋转。
14.根据权利要求13所述的输送装置,还包括输送护套,其从输送导管的远端远侧地延伸。
15.根据权利要求14所述的输送装置,还包括血管假体,其径向地约束在输送护套内,并且在假体的近端处能够释放地固定至尖端输送装置。
16.根据权利要求15所述的输送装置,还包括在假体近端处的至少一个支架,借以假体的近端在支架处能够释放地固定至尖端输送装置。
17.一种输送装置,其包括:
a)齿条;
b)柄部,其绕齿条延伸并在柄端处限定齿,该柄能够绕齿条旋转;
c)小齿轮,其能够绕与所述柄部的旋转轴线相交的轴线旋转并与齿条接合;
d)联接齿轮,其选择性地随着小齿轮的旋转而旋转;
e)致动器,其将小齿轮与联接齿轮选择性地接合;以及
f)输送导管,其固定至所述柄部,由此柄部的旋转根据小齿轮通过致动器与联接齿轮的接合,相对于齿条选择性地运动输送导管。
18.一种用于将血管假体输送至患者的治疗部位的方法,其包括以下步骤:
a)当尖端输送装置固定至导丝导管的远端,血管假体在假体的近端处安装至尖端输送装置时,将血管假体推进至在患者血管治疗部位远侧的位置;
b)以第一方向绕输送装置的具有远端的柄体旋转近侧柄部,导丝导管延伸穿过所述柄体,所述导丝导管设置在也延伸穿过柄体的推杆内,其中,导丝导管固定至推杆,由此近侧柄部的旋转引起导丝导管和推杆沿柄体的纵向运动,从而将假体至少部分地推进至治疗部位,所述假体在从柄体的远端绕假体延伸的外部导管内推进;
c)第一锁定组件将近侧柄部固定至推杆,将第一锁定组件的位置从第一位置转换至第二位置,由此第一锁定组件将近侧柄部从推杆脱离,并且第二锁定组件将推杆与柄体接合;
d)以第二方向旋转近侧柄部,由此具有远端并绕推杆延伸的输送导管沿推杆退回,并且从输送导管的远端延伸的输送护套从假体附近至少部分地缩回;
e)从尖端输送装置释放假体的近端;
f)转换第二锁定组件以将推杆从柄体脱离;以及
g)从假体内退回推杆和导丝导管,从而将血管假体输送至治疗部位。
19.根据权利要求18所述的方法,还包括将近侧柄部从柄体脱离的步骤,由此近侧柄部能够独立于近侧柄部的旋转沿柄体滑动。
20.根据权利要求19所述的方法,其中,当将假体推进至治疗部位时,近侧柄部从柄体脱离。
21.根据权利要求20所述的方法,其中,当输送护套从假体附近缩回时,近侧柄部从柄体脱离。
22.根据权利要求18所述的方法,其中,尖端输送装置为尖端卡扣总成,由此假体的支架的尖端由尖端卡扣总成保持直到释放。
23.根据权利要求22所述的方法,其中,通过缩回绕导丝导管延伸的尖端释放导管使假体从尖端卡扣总成释放,所述尖端释放导管固定至尖端卡扣总成的近侧捕捉组件,由此尖端卡扣总成的近侧捕捉组件从尖端卡扣总成的远侧捕捉组件分离,从而将假体的支架的尖端从近侧捕捉组件和远侧捕捉组件之间释放。
24.根据权利要求23所述的方法,其中,通过启动在近侧柄部处的致动器,近侧柄部的旋转从近侧柄部沿柄体的运动脱离。
25.根据权利要求24所述的方法,其中,通过将具有绕柄体延伸的齿的转换旋钮从第一位置旋转至第二位置,获得第一锁定组件的位置转换,使近侧柄部从推杆脱离。
26.根据权利要求25所述的方法,其中,将转换旋钮从第一位置旋转至第二位置同时地引起第二锁定组件将推杆与柄体接合。
27.根据权利要求26所述的方法,其中,转换旋钮接近柄体或者在柄体的远端。
28.根据权利要求27所述的方法,其中,转换旋钮通过具有近端和远端的驱动轴连接至近侧柄部,其中所述远端限定与转换旋钮的齿直接地或间接地接合的齿,所述转换旋钮限定在近端处的沿驱动轴的主纵向轴线的一排齿。
29.根据权利要求28所述的方法,其中,驱动轴在驱动轴的近端处与驱动齿轮接合,由此转换旋钮在转换旋钮的所有位置与驱动齿轮接合。
30.根据权利要求29所述的方法,其中,驱动齿轮在近侧柄部沿柄体的所有位置与驱动轴接合。
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CN107405196A (zh) * | 2015-03-13 | 2017-11-28 | 美敦力瓦斯科尔勒公司 | 用于带有容器调整装置的假体心脏瓣膜的递送装置 |
CN107405196B (zh) * | 2015-03-13 | 2020-08-28 | 美敦力瓦斯科尔勒公司 | 用于带有容器调整装置的假体心脏瓣膜的递送装置 |
WO2018120750A1 (zh) * | 2016-12-28 | 2018-07-05 | 苏州茵络医疗器械有限公司 | 自膨胀支架输送系统及其相关组件 |
CN106963528A (zh) * | 2017-05-02 | 2017-07-21 | 陈安富 | 医疗器械手柄操作端及介入治疗系统 |
CN111132638A (zh) * | 2017-07-27 | 2020-05-08 | 波士顿科学国际有限公司 | 用于形成具有抗迁移特征的支架的可调节芯轴 |
CN111132638B (zh) * | 2017-07-27 | 2022-03-29 | 波士顿科学国际有限公司 | 用于形成具有抗迁移特征的支架的可调节芯轴 |
CN114983506A (zh) * | 2022-05-25 | 2022-09-02 | 江苏畅医达医疗科技有限公司 | 支架输送装置及系统 |
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ES2618221T3 (es) | 2017-06-21 |
CN104363862B (zh) | 2016-10-05 |
US11998469B2 (en) | 2024-06-04 |
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JP6846470B2 (ja) | 2021-03-24 |
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US20190269539A1 (en) | 2019-09-05 |
US8998970B2 (en) | 2015-04-07 |
JP6238959B2 (ja) | 2017-11-29 |
US9554929B2 (en) | 2017-01-31 |
EP2846743A1 (en) | 2015-03-18 |
ES2618221T8 (es) | 2022-02-08 |
JP2015512746A (ja) | 2015-04-30 |
WO2013154749A1 (en) | 2013-10-17 |
JP6556210B2 (ja) | 2019-08-07 |
BR112014025430A2 (pt) | 2020-03-10 |
US11351049B2 (en) | 2022-06-07 |
JP2018033998A (ja) | 2018-03-08 |
JP2019193862A (ja) | 2019-11-07 |
US20170100271A1 (en) | 2017-04-13 |
US10299951B2 (en) | 2019-05-28 |
US20150173922A1 (en) | 2015-06-25 |
EP3141223A1 (en) | 2017-03-15 |
US20220257398A1 (en) | 2022-08-18 |
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