CN111225621B - 医疗设备及用于该医疗设备的锚定件 - Google Patents
医疗设备及用于该医疗设备的锚定件 Download PDFInfo
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Abstract
本公开的各个方面涉及用于放置在身体中的血管、附属结构和开口中的包括具有近端、远端和纵向轴线的框架的装置,系统和方法。在某些情况下,框架包括相对于纵向轴线成一定角度的腰部和沿着该腰部设置的一个或多个锚定件。
Description
相关申请的交叉引用
本申请要求2018年10月15日提交的美国申请第16/160,966号的优先权,该申请要求2017年10月16日提交的美国临时申请第62/572,763号的权益,两者全文均为了所有目的而以参见的方式纳入本文。
技术领域
本公开涉及具有可运动固定的可植入医疗设备,该可运动固定可用于阻塞、过滤和/或支承患者体内的孔、导管、空间、器官和其它结构和/或开口。
背景技术
各种医疗设备需要某种形式的固定或需要锚定至目标部位。常见的锚定件包括倒钩、钩子、缝线或其它用于将设备附连至周围解剖结构的特征。需要固定的设备的一些示例包括血管封堵器/塞子、血管过滤器、封堵器、腔静脉过滤器、支架、支架移植物、胆管/泌尿管支架、胃肠道支架和衬垫、各种监视器或诊断设备、中心静脉导管和其它设备。为了能经导管递送,这些设备可以预加载,并限制成小的轮廓,以允许微创递送至部位。一旦定位在期望的位置处,约束元件被移除,从而允许设备自扩张,或囊体扩张,并与周围的解剖结构接合。
当前的锚动件经常干扰设备加载、重新加载或压紧工艺。例如,当设备加载到小直径约束元件、例如导管中时,锚定件可能卡住或刺穿约束导管。锚定件需要与组织充分接合,典型地是通过从可植入医疗设备主体突出。这对将设备装入导管提出了挑战,因为锚定件会卡在导管的远侧末端和导管的内部,从而导致高负荷力、设备损坏或导管损坏。
发明内容
本公开的各个方面提供一种可植入医疗设备,该可植入医疗设备可用于阻塞、过滤和/或支承患者体内的孔、导管、空间、器官和其它结构和/或开口,包括心脏内的结构。本公开提供了可以使用经导管技术(尽管考虑了各种展开技术)部署到具有锚定件的患者中的医疗设备,锚定件分别响应于导管加载和展开而缩回和展开。本公开的各种实施例设计在将设备加载到导管中或在展开之后将设备重新加载回到导管期间朝向导管的中心轴线移位的锚定件。锚定件末端的位移足以消除加载时与导管的接触/相互作用。这是通过利用设备的主体设计、腰部以及将锚定基部放置在腰部远侧来实现的。
为了说明的目的,将描述用于阻塞患者的心耳的医疗设备。心脏有左心耳和右心耳。固定是必要的,以避免设备的栓塞,并考虑到动态运动的心脏跳动。
根据一示例(“示例1”),一种用于放置在身体中的血管、附属结构和开口中的设备,该设备包括具有近端、远端和纵向轴线的框架,所述设备包括:第一主体部分;相对于纵向轴线成角度的腰部;以及一个或多个锚定件,这些锚定件沿着腰部设置,并且构造成响应于框架设置成递送构造而相对于纵向轴线并朝向纵向轴线旋转,以避免锚定件末端与递送套管之间的接触。
根据相对于示例1更进一步的另一示例(“示例2”),该设备还包括第二主体部分,该第二主体部分相对于纵向轴线朝向远端向内渐缩,并且其中,腰部设置在第一主体部分与第二主体部分之间,并且所述一个或多个锚定件中的每一个包括设置在腰部处的根部,并且所述一个或多个锚定件构造成响应于框架设置成递送构造而在根部处朝向纵向轴线旋转。
根据相对于示例2更进一步的另一示例(“示例3”),第一主体部分或第二主体部分包括周向延伸的一排支柱对,其中相邻的支柱对连结在一起,所述一个或多个锚定件中的每一个在远端处包括末端,并且所述一个或多个锚定件构造成响应于框架设置成递送构造向内运动并而将末端设置在相邻的支柱对之间。
根据相对于示例2-3中任一项更进一步的另一示例(“示例4”),根部包括曲率部,在递送构造中该曲率部相对于纵向轴线的角度在大约-10度至零度之间,并且在展开构造中相对于纵向轴线的角度在大约10度至55度之间。
根据相对于示例1-4中任一项更进一步的另一示例(“示例5”),所述一个或多个锚定件构造成响应于框架设置成递送构造而在腰部处朝向纵向轴线旋转。
根据相对于示例5更进一步的另一示例(“示例6”),腰部包括相对于第一主体部分和第二主体部分的主体角度,并且该主体角度有助于一个或多个锚定件的响应于框架设置成递送构造的旋转。
根据相对于示例6更进一步的另一示例(“示例7”),主体角度展开构造中小于180°。
根据相对于示例7更进一步的另一示例(“示例8”),所述一个或多个锚定件在展开构造中的半径小于或等于主体角度。
根据相对于示例1-8中任一项更进一步的另一示例(“示例9”),还包括第二主体部分,并且其中,第二主体部分的柔性小于腰部的柔性。
根据又一示例(“示例10”),一种用于放置在身体中的血管、附属结构和开口中的具有递送构造和展开构造的设备,该设备包括:具有近端、远端和纵向轴线的框架,该框架包括:第一主体部分,该第一主体部分包括多个单元格;第二主体部分;腰部,该腰部设置在第一主体部分与第二主体部分之间,并且在第一主体部分与第二主体部分之间形成大约20度至90度之间的角度;至少一个锚定件,所述至少一个锚定件具有设置在腰部的远端处的根部以及朝向近端延伸的末端,所述至少一个锚定件在展开构造中从腰部相对于纵向轴线向外突出,并且在递送构造中嵌套在多个单元格中的一个或多个中。
根据相对于示例10更进一步的另一示例(“示例11”),所述至少一个锚定件构造成响应于框架从展开构造设置成递送构造而朝向纵向轴线旋转。
根据相对于示例10-11中任一项更进一步的另一示例(“示例12”),所述至少一个锚定件构造成响应于框架从递送构造设置成展开构造而相对于纵向轴线旋转并使锚定件末端向内运动。
根据相对于示例10-12中任一项更进一步的另一示例(“示例13”),所述至少一个锚定件中的每一个的根部距框架的远端大约为总设备长度的40%。
根据相对于示例10-13中任一项更进一步的另一示例(“示例14”),第一主体部分的柔性和第二主体部分的柔性中的至少一个小于腰部的柔性。
根据相对于示例10-14中任一项更进一步的另一示例(“示例15”),相邻支柱对的宽度在与所述至少一个锚定件相邻的地方减小。
根据又一示例(“示例16”),一种用于在身体的血管、附属结构和开口中展开设备的系统,该系统包括:
递送导管,该递送导管具有内腔和基本上圆形的主体部分的;以及具有近端、远端和纵向轴线的框架,该框架包括:第一主体部分;第二主体部分,该第二主体部分相对于纵向轴线朝向远端向内渐缩;腰部,该腰部设置在第一主体部分与第二主体部分之间;以及一个或多个锚定件,这些锚定件沿着腰部设置,并且构造成响应于框架设置在递送导管内而相对于纵向轴线并朝向纵向轴线向内运动,以避免锚定件末端与递送套管之间的接触。
根据相对于示例16更进一步的另一示例(“示例17”),所述一个或多个锚定件构造成响应于设置在递送导管内而朝向纵向轴线旋转而不接触基本上圆形的主体部分。
根据相对于示例16-17中任一项更进一步的另一示例(“示例18”),所述一个或多个锚定件构造成响应于从递送导管展开框架而相对于纵向轴线向外运动。
根据相对于示例16-18中任一项更进一步的另一示例(“示例19”),递送导管构造成在展开框架的近端之前展开框架的远端,并且所述一个或多个锚定件响应于以展开构造从递送导管展开框架而从腰部向外突出并朝向近端向上弯曲。
根据相对于示例16-19中任一项更进一步的另一示例(“示例20”),递送导管构造成响应于将框架拉入递送导管而从展开构造重新捕获框架,并使一个或多个锚定件朝向纵向轴线旋转。
根据另一示例(“示例21”),一种用于在身体的血管、附属结构和开口中展开设备的方法,该方法包括:设置用于递送的可植入医疗设备,该可植入医疗设备具有第一主体部分、相对于纵向轴线朝向远端向内渐缩的第二主体部分、设置在第一主体部分和第二主体部分之间的腰部以及沿着腰部设置的一个或多个锚定件;通过将设备加载到递送导管中来使设备塌缩,由此一个或多个锚定件响应于框架设置在递送导管内而朝向纵向轴线向内运动;通过将设备从递送导管展开并将框架扩张至展开构造来将设备植入体内,其中所述一个或多个锚定件构造成从纵向轴线径向向外运动并接合身体内的组织。
根据相对于示例21更进一步的另一示例(“示例22”),该方法还包括在植入设备之后将设备重新加载到递送导管中,以使一个或多个锚定件从组织上脱离,并使所述一个或多个锚定件朝向纵向轴线旋转。
根据相对于示例22更进一步的另一示例(“示例23”),该方法还包括在将设备重新加载到递送导管中之后,将该设备重新植入体内,其中一个或多个锚定件构造成从纵向轴线径向向外旋转并接合体内的组织。
尽管公开了多个实施例,但是仍有本申请的其它实施例将从以下详细的描述中对本领域技术人员变得明了,以下详细的描述示出和描述了本公开的示意性实施例。因此,附图和详细描述在本质上被认为是说明性的而不是限制性的。
附图说明
图1A是根据本公开的各个方面的人类心脏的剖视图,其中导管递送系统定位成准备将可植入医疗设备部署到心脏的左心耳(“LAA”)中。
图1B示出了根据本公开的各个方面的图1A的构造,其中可植入医疗设备从导管递送系统展开并且定位在LAA内。
图1C示出了根据本公开的各个方面的图1A的构造,其中可植入医疗设备从导管递送系统展开并且定位在血管内。
图2示出了根据本公开的各个方面的用于可植入医疗设备的示例性框架。
图3A是根据本公开的各个方面的可植入医疗设备的锚定件的正视图。
图3B是根据本公开的各个方面的如图3A所示的锚定件的侧视图。
图3C是根据本公开的各个方面的如图3A-3B所示的锚定件的立体图。
图4示出了根据本公开的各个方面的用于可植入医疗设备的另一示例性框架。
图5是根据本公开的各个方面的在变形为形状设定构造之前,框架的支柱切割图案的侧视图。
图6A示出了根据本公开的各个方面的示例性框架和锚定件,其中递送导管处于第一构造。
图6B示出了根据本公开的各个方面的处于第二构造的、如图6A所示的框架、锚定件以及递送导管。
图7示出了根据本公开的各个方面的用于约束具有不可运动或可缩回锚定件的可植入设备和具有可运动或可缩回锚定件的可植入设备的力的比较。
图8示出根据本公开的各个方面的不可运动锚定件的保持力和可运动或可缩回锚定件的保持力的比较。
图9示出了根据本公开的各个方面的用于可植入医疗设备的另一示例性框架。
图10示出了根据本公开的各个方面的用于可植入医疗设备的另一示例性框架。
图11示出了根据本公开的各个方面的用于可植入医疗设备的另一示例性框架。
图12示出根据本公开的各个方面的示例性锚定件的特写视图,以图10-11中的框架一同所示。
图13A示出了根据本公开的各个方面的用于可植入医疗设备的示例性框架,可植入医疗设备具有呈面向近侧的结构的锚定件。
图13B示出了根据本公开的各个方面的用于图13A所示的可植入医疗设备的示例性框架,可植入医疗设备具有呈面向远侧的结构的锚定件。
图14A示出了根据本公开的各个方面的用于可植入医疗设备的另一示例性框架,可植入医疗设备具有呈面向近侧的结构的锚定件。
图14B示出了根据本公开的各个方面的用于图14A所示的可植入医疗设备的框架,可植入医疗设备具有呈面向远侧的结构的锚定件。
图15示出了根据本公开的各个方面的用于可植入医疗设备的示例性框架,可植入医疗设备具有两组锚定件。
图16示出了根据本公开的各个方面的用于可植入医疗设备的示例性框架,可植入医疗设备具有两组锚定件。
尽管本公开适于各种修改和替代形式,但在附图中已以示例示出特定实施例并且在下文中详细描述。然而,意图不在于将本申请限制于所描述的实施例。与此相反,本公开旨在涵盖可包括落在由所附权利要求书限定的本公开范围内的所有修改、等同物以及替代物。
具体实施方式
本公开的各个方面涉及具有锚定件的可植入医疗设备。锚定件可构造成避免在加载到递送导管中以及从递送导管在患者体内展开期间损坏递送导管。医疗设备具有锚定件,当这些锚定件被约束以用于加载时和当未被约束以从诸如导管之类的约束元件卸载时,锚定件相对于医疗设备的纵向轴线径向运动。在某些实施例中,锚定件可朝向或远离可植入医疗设备实施例的纵向轴线或可植入医疗设备的外周移位、缩回、旋转和/或折叠。锚定件构造成在展开期间或之后与组织接合(例如,通过远离可植入医疗设备的主体的突起)。以这种方式与锚定件的展开/接合一致,锚定件的一部分(例如,锚定件末端)避免卡在递送导管的末端或导管内部,这会导致高加载力、设备损坏或导管损坏。锚定件避免与递送导管接触/相互作用。一些实施例具有在导管加载期间从导管移开的锚定件。锚定件末端的位移足以消除加载时与导管的接触/相互作用。这是通过利用设备的主体设计、腰部以及将锚定基部放置在腰部远侧来实现的。
可植入医疗设备可以是闭塞设备。本文讨论的闭塞设备被重新捕获并重新加载到递送导管中而不导致周围组织的损坏的能力更强。例如,在一些实施例中,闭塞设备的锚定构件在重新捕获和重新加载期间更加能够偏转。此外,在某些实施例中,锚定构件允许阻塞设备完全重新加载到递送系统中而不损坏阻塞设备和递送系统。因此,本文所提供的闭塞装置的各种实施例可基本无创伤地从组织中移除。在本文提供的闭塞设备的锚定件能够在重新捕获和重新加载期间无创伤地偏转的同时,锚定件提供了稳定的体内定位。
此外,可以观察到,本文提供的闭塞设备的某些实施例比市售的闭塞设备更加顺应(刚度较小)。这种增强的顺应性可以提供更好的密封性(闭塞设备与周围组织之间的接触更加连续)、提高的抗疲劳性、对患者更少的创伤、更稳定的定位,从而提供了一些示例性的益处。还可以说,本文提供的闭塞设备的实施例没有被设计为“驱动”组织使其与闭塞设备顺应。相反,闭塞设备通常旨在使其自身顺应于周围组织的天然形貌。
图1A-B是根据本公开的各个方面的人类心脏10的剖视图,其中递送系统20定位成准备将可植入医疗设备30部署到心脏的附属结构18中。图1A-B示出了心脏10的右心房14、左心房16、右心室32和左心室34的图示。如图所示,附属结构18位于心脏10的左心房16中,因此,附属结构18可认为是左心耳18。尽管以下讨论聚焦于将可植入医疗设备30部署到左心耳18中,但是可30在人类心脏10内的其它附属结构或开口中或人体的其它位置中展开可植入医疗设备。
左心耳18可认为是从心脏10的左心房16的前外侧壁36延伸的肌肉袋,其用作左心房16的贮存部。在正常的心动周期中,在心脏10的收缩期间,左心耳18可与左心房16的其余部分有节奏地收缩。因此,在正常的心动周期中,左心耳18与左心房16收缩并且泵送可聚集或收集在左心耳18内血液以离开其而循环。然而,在以心律不齐(例如心房纤颤)为特征的心动周期中,左心耳18可能无法与左心房16一起充分收缩,这可能使血液在左心耳18内停滞。心耳18内的停滞血液易于凝结并形成血栓,该血栓可能从心耳18中移出并最终导致栓塞性中风。与本公开的各个方面一致的可植入医疗设备30可递送至左心耳18,以帮助防止和减轻左心耳18内的血液停滞。
在某些实施例中,并且如图1A-B所示,可植入医疗设备30可借助微创经导管手术递送至左心耳18。更具体地,递送系统20可被导航通过腔静脉12,进入右心房14,穿过心房间隔15,并朝向附属结构18进入左心房16。在一些实施方式中,例如,经皮进入患者血管的通路可以在患者的股静脉处。应当理解的是,该示例技术仅仅是一个示例,并且还可以执行许多其它进入技术以展开本文提供的闭塞设备。在展开过程的这一点上,闭塞设备包含在递送系统20的内腔中,并且构造成塌缩的低轮廓递送构造。尽管总体示出并描述了经导管系统,但是还可以设想其它递送系统(例如胸腔镜)。
图1B示出了根据本公开的各个方面的图1A的构造,其中可植入医疗设备30从递送系统20展开并且定位在左心耳18内。如图所示,控制导管22能够可释放地联接至可植入医疗设备30,并且可滑动地设置在递送系统20的内腔内。临床医生可以使用控制导管22以使可植入医疗设备30从递送系统20展开。例如,在通过左心耳18的孔口38定位可植入医疗设备30之后,临床医生操作员可以相对于控制导管22缩回递送系统20以脱套并展开可植入医疗设备30。孔口38可认为是左心房16的前外侧壁36的一部分,从该部分开始渐缩以形成左心耳18的袋状结构。可植入医疗设备30可包括闭塞面40,该闭塞面40设置在左心耳18的孔口38附近。控制导管22可以经由毂部或中心框架部分或者插入到中心框架部分中的插塞(或类似物)可释放地联接至可植入医疗设备30,该中心框架部分设置在可植入医疗设备30的闭塞面40的中心。
在脱离递送系统20的约束范围之后,可植入医疗设备30可以重新构造成扩张构造。可植入医疗设备30可扩张至符合限定在左心耳18内的空间的轮廓。在某些实施例中,可增强可植入医疗设备30相对于左心耳18的空口38的定位,并确保可植入医疗设备30防止血栓从左心耳18栓塞。更具体地,闭塞面40可设置在左心耳18内,使得闭塞面40连接前外侧壁36的在孔口38的相对侧上的部分,以形成基本上均匀的表面。在某些情况下,如果闭塞面部相对于左心耳18的孔口38不均匀(例如,具有突出超过闭塞面的其它部分的接口的设备;具有凹入、部分凹入的闭塞面或包括凹陷部的设备,或具有凹入、部分凹入的闭塞面的设备),或者闭塞面部包括突出部,则血液会沿着植入其中的设备的表面聚集或停滞。在这些情况下,血栓可能沿着可植入医疗设备30的表面发生,因为不均匀的表面可能改变/破坏左心房18内的血流。因此,如果由于不适当的定位或设备的设计而导致可植入医疗设备30包括不均匀的表面,则患者可能仍然容易遭受血液凝固和血栓形成。
在可植入医疗设备30的适当定位和递送之后,控制导管22可以从可植入医疗设备30脱离,并且可从患者体内移除递送系统20和控制导管22。在如图所示展开可植入医疗设备30的情况下,借助于由可植入医疗设备30提供的物理屏障,在左心耳18内限定的空间基本上与左心房16分开。以这种方式,可防止容易遭受凝结并形成血栓的LAA 18内的停滞血液进入左心房16,从而防止潜在地引起栓塞性中风。此外,可植入医疗设备30的闭塞面40相对于左心耳18的孔口38的定位可帮助防止血液沿着可植入医疗设备30的表面聚集或停滞。
如上所述,本文提供的设备可以在身体的许多不同区域中使用,将可植入医疗设备30部署到左心耳18中只是一种示例性实施方式。更具体地,图1C示出了根据本公开的各个方面的图1A的构造,其中可植入医疗设备从导管递送系统展开并且定位在血管壁42之间的血管内。在每个植入位置处,作用在可植入医疗设备30上的力(比如血液泵送或肌肉收缩)可能导致可植入医疗设备30从植入位置移开。如以下进一步详细讨论的,可植入医疗设备30可以包括锚定件,该锚定件可以朝向可植入医疗设备30移位、缩回、旋转和/或折叠,并且避免卡在递送系统20和/或控制导管22的末端或内部上,这会导致高加载力、设备损坏或导管损坏。
图2示出了根据本公开的各个方面的用于可植入医疗设备的示例性框架200。可植入医疗设备可以是用于放置在体内的血管、附属结构和开口中的设备。框架200可以是由多个支柱202形成的整体框架(为了易于理解,图2突出显示了多个支柱202中的四个)。在某些实施例中,框架200可以是整体的并且是自扩张的。框架200可包括若干主体部分,这些主体部分具有不同的形状、角度或其它特征(如参照图4进一步详细解释的)或者可以是另一种形状,比如圆柱形、圆锥形、截头圆锥形、半球形、球形盖、金字塔形、截头金字塔形等及其组合。在本公开的范围内,可以设想这种不同形状以及形状的不同几何图形的任何和所有组合和子组合。
框架200可包括由支柱202形成的任何数量的排和单元格。支柱202可连续形成多个单元格。突出显示了单个单元格204(如图所示,框架200包括多个相似的单元格)。(一个或多个)单元格204可以由五边形、六边形或其它形状形成,例如但不限于多边形、正方形、矩形、平行四边形、斜方形、梯形、菱形、人字形、八角形、三角形等。如图2所示,框架200在单元204的远侧部分处向内渐缩。框架200过渡至渐缩部的点是框架200的腰部208。
除了将框架200过渡至渐缩部分之外,一个或多个锚定件206也可位于腰部208处。一个或多个锚定件206可位于单元204的支柱202会聚位置的附近或在支柱202会聚的部分处。沿着腰部208设置的一个或多个锚定件206构造成响应于框架200设置成递送构造而相对于纵向轴线并且朝向纵向轴线向内运动(例如旋转)。一个或多个锚定件206可向内缩回、运动或旋转,使得当框架200加载到递送导管中并成为递送构造(例如,为经导管递送而塌缩)时,一个或多个锚定件206在框架200加载到递送导管中期间不会卡在递送导管上。在某些情况下,锚定件206旋转以避免锚定件末端与递送导管之间的接触。在某些实施例中,腰部208通过充当框架200的铰链而有助于一个或多个锚定件旋转。框架200在设置成递送构造时向内塌缩,并且腰部208可有助于一个或多个锚定件206的旋转。锚定件206围绕框架200的周缘设置在框架200的一部分内,并且设置在(一个或多个)单元格204中的每一个内,这些单元格204一起形成周向延伸的成排的支柱对202。如图2所示,框架200的区域突出显示(“A”),这在图3A-C中更详细地示出。
图3A是根据本公开的各个方面的可植入医疗设备的锚定件206的正视图。如图3A所示,相邻的支柱202a对在(一个或多个)单元格204内在接合部310处会聚在一起。更具体地,支柱202a连结在一起,并且支柱202b在腰部208处连续并分开。接合部310存在于图2所示的(一个或多个)单元格204中的每一个中,如由支柱202b连结在一起形成。尽管图2示出了多个接合部310,但是与本公开的各个方面一致的可植入医疗设备可包括任何数量(一个、两个、三个、四个、五个、六个、十二个、二十四个或其间任何数量)的单元格204。
锚定件206可设置在接合部310处或与接合部310相邻。如图3A所示,锚定件206从接合部310延伸。更具体地,锚定件206包括位于接合部310(如图3A所示)或与接合部310相邻的锚定件根部312。在某些实施例中,如从框架200的远端测量的,锚定件根部312为框架200的总长度的大约25%至60%。锚定件206在支柱202a之间延伸,并且可构造成响应于框架200设置成递送构造而在根部312处朝向框架200的纵向轴线向内运动(例如,通过旋转)。锚定件206可旋转并向内旋转并且因此相对于框架200的纵向轴线缩回。在某些情况下,锚定件206旋转以避免锚定件末端316与递送导管之间的接触。在某些情况下,锚定件206的末端316避免与递送导管或套管接触。当过渡到递送构造时旋转的锚定件206使末端316(其从远端测得的长度可大约是锚定件206的长度的1%、2%、3%、4%、5%、6%、7%、8%、9%、10%)与递送导管或套管不接触。在其它情况下,以这种方式旋转的锚定件206将末端316带到框架200的内部。在某些情况下,锚定件206旋转并且锚定件末端316向内运动。
根部312设置在框架200的腰部208处。如上所述,腰部208因框架200的角度改变或渐缩而出现。在使框架200塌缩成递送构造(例如,如图6A-B所示,设备伸长以装配在递送导管内)的情况下,框架200在腰部208处的角度改变或渐缩有助于锚定件206向内运动(例如,缩回/旋转)。因此,锚定件206构造成响应于框架200设置成递送构造而在腰部208处朝向纵向轴线旋转。
在某些实施例中,锚定件206从设置在根部312处的基部314朝着末端316渐缩至。从基部314到末端316的渐缩可有助于锚定件206刺穿组织的能力。如从图3A中的“B”线所观察的,图3B是根据本公开的各个方面的如图3A所示的锚定件的侧视图。如侧视图所示,锚定件206通过其长度具有恒定的深度,其中锚定件206的宽度朝向末端316渐缩。此外,如图3B所示,锚定件206包括曲率部(曲率)318。在框架200的展开构造中,曲率部318使锚定件206从框架200向外延伸。当框架200从展开构造(图2所示)过渡到递送构造时,曲率部318保持恒定,同时相邻的支柱202a的曲率改变。在某些实施例中,锚定件206的曲率部318减小,使得锚定件206相对于框架200向内并且在支柱202a之间旋转。
在某些实施例中,根部的曲率部318在递送构造中相对于纵向轴线具有在大约(正负-1%)-10度至零度之间的角度,并且在如图3B所示的展开构造中相对于纵向轴线具有在大约(正负-1%)10度至55度之间的角度。在其它情况下,根部的曲率部318在递送构造中相对于纵向轴线具有在大约(正负-1%)-30度至10度之间的角度,并且在如图3B所示的展开构造中相对于纵向轴线具有在大约(正负-1%)5度至65度之间的角度。锚定件的曲率部318可从穿过末端316和基部314的切线测量。在某些情况下,曲率部318可在5至90度之间。在某些情况下,锚定件206的末端316可相对于支柱312向外突出约0.2毫米与约1毫米之间。如参照图6A和图6B所指出的,当从展开构造过渡到递送构造时,锚定件206的末端316可旋转以避免接触递送套管。锚定件206的突出量可以与锚定件的曲率部318和锚定件206的长度的组合有关。结果,在某些情况下,锚定件的曲率部318和锚定件206的长度的组合产生了如下的锚定件206,该锚定件206从支柱312向外延伸约0.2毫米至约0.7毫米之间或约0.4毫米至约0.6毫米之间。
图3C是根据本公开的各个方面的如图3A-B所示的锚定件206的立体图。如图3C所示,锚定件206相对于支柱202a向外延伸。
图4示出了根据本公开的各个方面的用于可植入医疗设备的另一示例性框架200。可植入医疗设备可以是用于放置在体内的血管、附属结构和开口中的设备。框架200可包括近端420、远端422和纵向轴线424。框架200包括在框架200的近端420处的面部426。
此外,框架200包括第一主体部分428,该第一主体部分428包括周向延伸的一排支柱对202,其中相邻的支柱对202a在框架的一个或多个接合部310处会聚在一起。尽管框架包括多个相邻的支柱对202a和接合部310,但是为了易于理解,在图4中突出了单组相邻的支柱对202a和单个接合部310。框架200还包括设置在第一主体部分428的远侧的第二主体部分430。第二主体部分430可相对于纵向轴线424朝向远端422向内渐缩。此外,框架200可包括设置在第一主体部分428与第二主体部分430之间的腰部208。
框架200还包括锚定件206(为了易于理解,在图4中突出显示了单个锚定件206)。锚定件206沿着腰部208或在腰部208内设置在接合部310处或者与接合部310相邻地设置。此外,锚定件206构造成响应于框架200以递送构造(例如,如图6A-B所示)设置而相对于纵向轴线424并朝向纵向轴线424向内运动(例如旋转)。在某些实施例中,腰部208可包括相对于第一主体部分428和第二主体部分430的主体角度432。主体角度432可有助于锚定件206响应于框架200设置成递送构造进行的旋转。如图4所示,锚定件206设置在腰部208的远端434处。在某些实施例中,锚定件206的根部(例如,如图3A-C所示)在腰部208的远端422处。
此外,锚定件206构造成响应于从递送构造设置成展开构造的框架200而从纵向轴线424向外运动。锚定件206构造成当从递送导管展开时从纵向轴线424向外移动,从而允许锚定件206植入身体的组织内。
在递送构造中,框架200相对于纵向轴线424伸长并塌缩。腰部208和腰部208的主体角度432例如充当铰链,以有助于锚定件206响应于框架200设置成递送构造而进行的旋转。腰部208在框架200的其余部分向内压缩之前或以比框架200的其余部分更快的速率向内压缩,框架200的该其余部分向内承载锚定件206。在某些实施例中,在如图4所示的展开构造中,主体角度432小于180°。在某些实施例中,主体角度432在大约(正负1%)20度与90度之间。此外,第一主体部分428的柔性和/或第二主体部分430的柔性可小于腰部208的柔性,以进一步有助于腰部208起到铰链的作用以使锚定件206向内和向外运动。在某些情况下,框架200或框架200的若干部分的柔性可以是纵向弯曲的柔性。例如,腰部208可比第一主体部分428和第二主体部分430中的一个或两个更具柔性。在某些情况下,腰部208可以比第一主体部分428和第二主体部分430中的一个或两个更软。
在某些实施例中,框架200具有单一的角度变化,即主体角度432,可有助于锚定件206向内和向外运动。如上所述,当框架200从展开构造设置成递送构造时,框架200塌缩。在此过渡期间,主体角度432从框架200的塌缩中伸直。框架在主体角度432处的角度变化允许框架200具有铰接点以将锚定件206向内缩回。不包括多个角度变化的框架200有助于框架200的均匀塌缩(例如,如图6A-B所示),而不迫使框架200在多个拐点处向内折叠,这可能导致框架不均匀塌缩,而锚定件不缩回或旋转。进一步地,如图4所示,具有敞开的远端422的框架200还有助于锚定件206的缩回或旋转。远端422是敞开的(例如,没有毂部(中心)组件)允许框架200向内折叠而没有抑制远端422自由运动而保持扩张或展开的闭合端,并有助于框架200塌缩成细长递送构造。以这种方式,框架200通过缩回到递送导管中(例如,如图6A-B所示)来塌缩,而不需要向远端422施加塌缩力。锚定件206也向内保持,而递送导管不将锚定件206保持或强迫锚定件206处于塌缩位置。锚定件206的向外旋转可在没有递送导管协助的情况下发生。
图4中所示的说明性部件并不旨在对所公开的主题的各实施例的使用或功能的范围提出任何限制。说明性部件也不应被解释为具有与其中所示的任何单个部件或部件的组合相关的任何依赖性或要求。此外,在实施例中,在图4中的任一个中所示的任何一个或多个部件可与在此所示的各种其它部件(和/或未示出的部件)集成在一起,所有这些都被认为是在所公开的主题的范围内。例如,参照图2描述的框架200可与递送系统(在图1A-B和图6A-B中示出)结合使用。更具体地,框架200可形成可植入医疗设备30的一部分。另外,框架200可包括附连于其的隔膜(例如,如参照图1所示和所讨论的)。
图5是根据本公开的各个方面的在变形为形状设定构造(例如,如图2和4所示)之前,框架的支柱切割图案500的侧视图。可使用镍钛诺片材。图案500产生带有锚定件206的框架。图案500还可以用于形成多个支柱202。
如图5所示,支柱202(为了易于理解而突出显示单个相邻对)在整个图案500上通常包括共同的宽度。然而,支柱202包括与锚定件206相邻的减小的宽度532的部分。减小的宽度532部分在宽度方向上与每个锚定件206相邻,并且在长度方向上与每个接合部310相邻。在某些实施例中,减小的宽度532部分可对应于框架200的腰部208(例如,如图2和4所示)。在某些实施例中,减小的宽度532部分使腰部208比框架200的其它部分更具柔性。在其它实施例中,对腰部208进行不同于框架200的其它部分的热处理(作为减小宽度532部分的附加或替代),以增强柔性。
图6A示出了根据本公开的各个方面的示例性框架200和锚定件206,其具有处于第一构造的套管634(或诸如递送导管之类的递送设备)。图6A中所示的第一构造可认为是框架200的展开构造(例如,如图2和4所示)。锚定件206相对于框架200向外突出。展开构造可在框架200加载到套管634中以植入体内之前,还可在框架200从套管634被卸载或展开到身体中之后。
图6B示出了根据本公开的各个方面的处于第二构造的、如图6A所示的框架200、锚定件206以及套管634。第二构造示出了框架200撤回到套管634中或从套管634展开。框架200不完全处于递送构造中(例如,在套管634内)。如比较图6A和图6B所示,已经向外突出图6A所示的展开构型的锚定件206响应于框架200撤回到套管634内而相对于纵向轴线并朝向纵向轴线向内运动(例如旋转)。在某些实施例中,锚定件206在递送构造中与相邻的支柱202基本上对准。
套管634在套管634的远端处包括基本上圆形的主体部分636。基本上圆形的主体部分636是内腔638的进入/离开点,框架200可撤回到其中,以用于框架200的后续展开或重新展开。如图6B所示,响应于框架200过渡到递送构造,锚定件206构造成向内旋转,使得锚定件206不接触套管634的基本上圆形的主体部分636(或其它部分)。锚定件206的一些部分(比如锚定件末端)还可避免在撤回到套管634的内腔638中时与套管634的内腔638接触。在没有将锚定件206构造成以这种方式向内旋转的情况下,操作套管634的使用者在试图将框架200缩回到套管634中时会遇到较大的阻力。锚定件206构造成向内旋转可在展开过程中避免不必要的阻力。不必要的阻力还会通过使框架200不可修复地起皱或折叠而损坏框架200本身。因此,锚定件206构造成以这种方式向内旋转避免了损坏套管634,避免损坏框架200,并且易于包括框架200的可植入医疗设备的递送和展开。在某些情况下,锚定件206的末端避免与套管634接触。当过渡到递送构造时锚定件206旋转使末端(其从远端测得的长度可大约是锚定件206的长度的1%、2%、3%、4%、5%、6%、7%、8%、9%、10%)与套管634不接触。在其它情况下,以这种方式旋转的锚定件206将末端带到框架200的内部。
锚定件206还构造成响应于从套管634展开框架200而从纵向轴线向外运动。除了展示当框架从展开构造过渡到递送构造时锚定件206的构造或位置变化之外,通过比较图6B中的第二构造和图6A中的第一构造还展示锚定件206的向外偏转。如图6B所示,当框架的远端422缩回到套管634中时,框架的远端422已经扩张。敞开的远端422有助于塌缩力在整个框架中的传递,以允许框架200塌缩成细长递送构造。以这种方式,框架200通过缩回到导管634中来塌缩,而不需要向远端422施加塌缩力。
套管634构造成将框架200的远端422扩张至框架200的近端(在图6A中示出为接触套管634的基本上圆形的主体部分636)。另外,在图6A所示的展开构造中,锚定件206(从腰部208)向外突出并且朝向近端向上弯曲。锚定件206响应于从套管634展开框架200而向外运动。
在某些实施例中,套管634的使用者可将框架200(和可植入医疗设备)重新捕获在套管634内。在通过从套管634展开框架200并使框架200扩张至展开构造而将框架200植入体内之后,框架200的放置可能不在期望的位置或期望的角度。因此,使用者可希望重新捕获并重新展开框架200。在这些实施例中,套管634构造成将框架200缩回到套管634中(进入递送构造),而锚定件206构造成径向向内旋转并从体内的组织脱离。由于缩回运动,锚定件206无创伤地脱离组织。
图7示出了根据本公开的各个方面的用于约束具有不可运动或可缩回锚定件700的可植入设备和具有可运动或可缩回锚定件702的可植入设备的力的比较。图7示出了表示每个不可运动或可缩回锚定件700和可运动或可缩回锚定件702的测量力的范围的数据图。该数据模拟使用者在试图撤回具有不可运动或可缩回锚定件700的可植入医疗设备或与可植入医疗设备一起设置的可运动或可缩回锚定件702时所遇到的力。
如图7所示,与可运动或可缩回的锚定件702相比,为了约束不可运动或不可缩回的锚定件700,需要更大或更高的力范围。如本文中详细讨论的,可运动或可缩回的锚定件702增强了可植入医疗设备约束在递送构造内的能力。
图8示出根据本公开的各个方面的不可运动或不可运动的锚定件700和可运动(例如,可旋转)或可缩回的锚定件702的保持力的比较。图8示出了表示每个不可运动或不可缩回锚定件700和可运动或可缩回锚定件702能够提供的测量的保持力的范围的数据图。当与可植入医疗设备一起设置时,该数据模拟不可运动或不可缩回的锚定件700或可运动或可缩回的锚定件702的保持力。
如图8所示,与可运动或可缩回的锚定件702相比,不可运动或不可缩回的锚定件700具有较小范围的保持力。可运动的或可缩回的或可旋转的锚定件702增强了可植入医疗设备的将可植入医疗设备保持在植入部位处的能力,如本文中详细讨论的。
图9示出了根据本公开的各个方面的用于可植入医疗设备的另一示例性框架900。如图9所示,框架900包括与图2的框架200和图4的框架200不同的构造。类似于图2的框架200和图4的框架200,框架900包括腰部208和设置在腰部208处的锚定件206。腰部208位于框架900上,其中框架900朝向其远端渐缩。
此外,锚定件206构造成响应于框架900设置成递送构造而向内旋转。腰部208可充当铰链以助于锚定件206构造成向内旋转。
图10示出了根据本公开的各个方面的用于可植入医疗设备的另一示例性框架1000。如图10所示,框架1000包括与图2的框架200和图4的框架200不同的构造。类似于图2的框架200和图4的框架200,框架1000包括腰部208和设置在腰部208处的锚定件206。腰部208位于框架1000上,其中框架1000朝向其远端渐缩。锚定件206还设置成与接合部310相邻。图10的锚定件206相对于接合部310为侧鞍形。
此外,锚定件206构造成响应于框架1000设置成递送构造而向内旋转。如以上进一步详细讨论的,腰部208可充当铰链以有助于锚定件206构造成向内旋转。
图11示出了根据本公开的各个方面的用于可植入医疗设备的另一示例性框架1100。如图11所示,框架1100包括与图2的框架200和图4的框架200不同的构造。类似于图2的框架200和图4的框架200,框架1100包括腰部208和设置在腰部208处的锚定件206。腰部208位于框架1100上,其中框架1100朝向其远端渐缩。锚定件206还设置成与接合部310相邻。图11的锚定件206相对于接合部310为侧鞍形。
此外,锚定件206构造成响应于框架900设置成递送构造而向内旋转。腰部208可充当铰链以有助于锚定件206构造成向内旋转。
图12示出根据本公开的各个方面的示例性锚定件的特写视图,随图9-10中的框架一同所示。
图10-12中所示的说明性部件并不旨在对所公开的主题的实施例的使用或功能的范围提出任何限制。说明性部件也不应被解释为具有与其中所示的任何单个部件或部件的组合相关的任何依赖性或要求。此外,在实施例中,在图10-12中的任一个中所示的任何一个或多个部件可与在此所示的各种其它部件(和/或未示出的部件)集成在一起,所有这些都被认为是在所公开的主题的范围内。例如,参照图1-6描述的框架可包括如图10-12所示的侧鞍形锚定件。
图13A示出了根据本公开的各个方面的用于可植入医疗设备的示例性框架1300,可植入医疗设备具有呈面向近侧的结构的锚定件1302。框架1300可形成诸如支架或支架移植物之类的可植入医疗设备的一部分。锚定件1302设置在框架1300的腰部1304处。腰部1304是框架1300的一部分,该部分包括改变框架1300的角度的曲率部,如图13A所示。同样如图13A所示,框架1300包括两个弯曲部分:腰部1304和部分1306。锚定件1302还可设置在部分1306处。在某些实施例中,框架1300包括设置在腰部1304和部分1306处的锚定件1302。
锚定件1302构造成响应于框架1300设置成递送构造而向内旋转。腰部1304(或部分1306)可充当铰链以有助于锚定件1302构造成向内旋转。框架1300在设置成递送构造时向内塌缩,并且腰部1304可有助于一个或多个锚定件1302的旋转。
如图13A所示,锚固件1302的根部1308设置在腰部1306的曲率部的端部处。锚定件1302可构造成响应于框架1300设置成递送构造而在根部1308处朝向框架1300的纵向轴线向内运动(例如,通过旋转)。在使框架1300塌缩成递送构造(例如,如图6A-B所示,设备伸长以装配在递送导管内)的情况下,框架1300在腰部1304处的角度改变或渐缩有助于锚定件1302向内旋转。因此,锚定件1302构造成响应于框架1300设置成递送构造而在腰部1304处朝向纵向轴线旋转。
锚定件1302相对于框架1300的端部呈面向近侧的结构。图13B示出了根据本公开的各个方面的用于图13A所示的可植入医疗设备1300的示例性框架,可植入医疗设备具有呈面向远侧的结构的锚定件1302。在任一结构中,锚定件1302构造成在框架1300内旋转。
图14A示出了根据本公开的各个方面的用于可植入医疗设备的另一示例性框架1400,可植入医疗设备具有呈面向近侧的结构的锚定件1402。框架1400可形成诸如腔静脉过滤器之类的可植入医疗设备的一部分。锚定件1402设置在框架1400的腰部1404处。腰部1404是框架1400的一部分,该部分包括改变框架1400的角度的曲率部,如图14A所示。锚定件1402构造成响应于框架1400设置成递送构造而向内旋转。腰部1404充当铰链以助于锚定件1402旋转。框架1400在设置成递送构造时向内塌缩,并且腰部1404可有助于一个或多个锚定件1402的旋转。
如图14A所示,锚定件1402的根部1408设置在腰部1406的曲率部的端部处。锚定件1402可构造成响应于框架1400设置成递送构造而在根部1408处朝向框架1400的纵向轴线向内运动并旋转(例如,通过缩回或旋转)。在使框架1400塌缩成递送构造(例如,如图6A-B所示,设备伸长以装配在递送导管内)的情况下,框架1400在腰部1404处的角度改变或渐缩有助于锚定件1402向内旋转。因此,锚定件1402构造成响应于框架1400设置成递送构造而在腰部1404处朝向纵向轴线旋转。
锚定件1402相对于框架1400的端部呈面向近侧的结构。图14B示出了根据本公开的各个方面的用于图14A所示的可植入医疗设备1400的示例性框架,可植入医疗设备具有呈面向远侧的结构的锚定件1402。在任一结构中,锚定件1402构造成在框架1400内旋转。
图15示出了根据本公开的各个方面的用于可植入医疗设备的示例性框架1500,可植入医疗设备具有两组锚定件1502、1504。框架1500可形成诸如支架或支架移植物之类的可植入医疗设备的一部分。两组锚定件1502、1504设置在框架1500的腰部1506、1508处。腰部1506、1508是框架1500的部分,这些部分包括改变框架1500的角度的曲率部,如图15所示。
锚定件组1502、1504构造成响应于框架1500设置成递送构造而向内旋转。腰部1506、1508可充当铰链以助于锚定件1502、1504构造成向内旋转。框架1500在设置成递送构造时向内塌缩,并且腰部1506、1508可有助于锚定件1502、1504的旋转。
图16示出了根据本公开的各个方面的用于可植入医疗设备的示例性框架1600,可植入医疗设备具有两组锚定件。根据本公开的各个方面,框架1600包括两组锚定件1602、1604。两组锚定件1602、1604面向框架1600的相对端。两组锚定件1602、1604设置在框架1600的腰部1606处。腰部1606的特征在于,腰部1606包括改变框架1600的角度的曲率部,如图16所示。
两组锚定件1602、1604构造成响应于框架1600设置成递送构造而向内旋转(或缩回)。腰部1606可充当铰链以助于两组锚定件1602、1604构造成向内旋转。框架1600在设置成递送构造时向内塌缩,并且腰部1606可有助于两组锚定件1602、1604的旋转。
镍钛诺(NiTi)可用作本文讨论的框架的材料。在其它情况下,框架可由其它材料形成,比如不锈钢、L605钢、聚合物、MP35N钢、聚合材料、Pyhnox、埃尔吉洛伊非磁性合金(Elgiloy)或任何其它合适的生物相容的材料,并且它们的组合可以用作框架的材料。NiTi的超弹性和柔软性可增强框架的顺应性。此外,可以将NiTi形状设定为期望的形状。即,NiTi可以形状设定成使得当框架不受约束时,例如当框架从递送系统展开时,框架趋向于自扩张成期望的形状。更具体地,框架(由NiTi制成)可具有弹簧性质,该弹簧性质允许框架被弹性塌缩或“挤压”为低轮廓的递送构造以用于加载在递送系统中(例如,如参考图1A和图6A-B所示和所讨论的)示,然后在从递送系统露出后重新构造成如图2和4所示的扩张构造。本文所讨论的框架通常可以是适形的、抗疲劳的并且是弹性的,使得当闭塞设备在患者体内展开时,框架可符合周围组织的形貌。在某些实施例中,生物再吸收或生物可吸收的材料可用于框架或其一部分,包括例如生物再吸收或生物可吸收的聚合物。
在某些情况下,如图1A-C所示,用于隔膜的生物相容的材料可覆盖本文讨论的框架。在某些实施例中,隔膜可包括含氟聚合物,比如聚四氟乙烯(PTFE)聚合物或膨胀聚四氟乙烯(ePTFE)聚合物。在一些实施例中,隔膜可由聚酯、硅树脂、尿烷、聚对苯二甲酸乙二醇酯或其他种生物相容的聚合物或其组合形成。在一些实施例中,可使用生物再吸收或生物可吸收的材料,例如生物再吸收或生物可吸收的聚合物。在一些实施例中,该膜可包含诸如在美国专利第7049380号;第7462675号;和第8048440号中所描述的含氟聚合物,其内容均以参见的方式纳入本文。在一些实施例中,隔膜可包含涤纶、聚烯烃、羧甲基纤维素织物、聚氨酯或其它机织或薄膜弹性体。在一些实施例中,隔膜可以包括针织物或纤维。在包括例如丝线的各种实施例中,隔膜可以是织造的或非织造的。在一些实施例中,隔膜70可由含氟聚合物或其混合物的组合和/或共聚物形成。
在一些实施例中,隔膜构造成抑制、过滤、调节或基本上调节流体和/或材料(例如血液和/或血栓)通过隔膜。在一些实施例中,隔膜构造成在其中引起快速的组织向内生长。在一实施例中,该隔膜提供了血液或体液不可渗透的隔膜,其阻塞了血液或体液流过该隔膜膜,而促进了向内生长和内皮化。隔膜可具有微孔结构,该微孔结构提供了组织向内生长支架,以持久地阻塞并增加框架的锚定强度。在一些实施例中,隔膜可以是多孔构件。隔膜的孔的大小可确定为基本上或在一些示例中完全帮助防止血液、其它体液和栓子通过。在一些实施方式中,该隔膜防止或基本上防止血液、其它体液、血栓、栓子或其它身体材料通过该隔膜。
如本文关于测量范围(例如上面刚刚公开的那些)所使用的术语,“大约”和“近似”可互换地使用,以指代包括所述测量并且还包括合理地接近所述测量但是可以相差合理小的量的任何测量的测量,所述合理小的量如相关领域的普通技术人员将理解并且容易确定的可归因于测量误差、测量和/或制造设备校准的差异、读取和/或设定测量中的人为误差、考虑与其它部件相关联的测量中的差异而进行的优化性能和/或结构参数的调整、特定实现方案、人或机器对物体的不精确调整和/或操纵等。
本文已经描述了若干种可植入的闭塞设备和框架实施例。应当理解的是,在具体设备的内容中描述的一个或多个特征可与本文描述的任何其它设备或多个设备的一个或多个特征组合。即,本文描述的闭塞设备和框架的特征可被混合和匹配以提供混合闭塞设备和设备框架实施例,并且这种混合闭塞设备和设备框架实施例在本公开的范围内。在一些示例中,关于具体设备或框架描述的一个或多个特征可替换或替代另一设备或框架的一个或多个特征。在某些示例中,关于具体设备或框架的一个或更多特征可加入到或包括于另一设备或框架。此外,此处所描述的特征的各种组合或子组合可总体用于此处描述的任何设备或框架。应当理解的是,本文提供的闭塞设备和闭塞设备框架可对于大范围的尺寸缩放,使得闭塞设备可用于多种不同的解剖结构、植入部位和实施类型。
前面的描述已经给出了许多特征和优点,包括各种替代的实施方式,以及装置和/或方法的结构和功能的细节。本公开所述仅意在图示,而并不意在穷举。对于本领域的技术人员来说显然可在本发明的原理范围内在所附权利要求书所表达术语的宽泛上位含义所指示的最大范围内进行各种改型,尤其是在结构、材料、元素、部件、形状、尺寸和部件的布置。在这些多种改变不偏离所附权利要求书精神和范围的程度上,它们属于本发明范围内。在此包括随其包含的附图在内的所有文献、出版物和专利的全部内容以参见的方式纳入本文。
Claims (20)
1.一种用于放置在身体中的血管、附属结构和开口中的设备,所述设备包括具有近端、远端和纵向轴线的框架,所述设备包括:
闭塞面,所述闭塞面布置在所述框架的近端处,所述闭塞面部分地由朝向所述纵向轴线径向延伸的支柱限定;
第一主体部分,其具有从所述闭塞面向远侧延伸的向外弯曲部;
第二主体部分,其相对于所述纵向轴线朝向所述远端向内渐缩;
腰部,所述腰部相对于所述纵向轴线成角度,且所述腰部设置在所述第一主体部分与所述第二主体部分之间;以及
一个或多个锚定件,所述一个或多个锚定件沿着所述腰部设置在会聚在所述腰部处的所述框架的相邻的支柱之间,并且所述一个或多个锚定件构造成响应于所述框架设置成递送构造而相对于所述纵向轴线并朝向所述纵向轴线向内运动,以避免锚定件末端与递送套管之间的接触,并且所述一个或多个锚定件的一个或多个根部包括在展开构造中相对于所述纵向轴线的角度在10度到55度之间的曲率部。
2.如权利要求1所述的设备,其特征在于,所述腰部设置在所述第一主体部分与所述第二主体部分之间,并且所述一个或多个锚定件构造成响应于所述框架设置成所述递送构造而在所述根部处朝向所述纵向轴线旋转。
3.如权利要求2所述的设备,其特征在于,所述第一主体部分或所述第二主体部分包括周向延伸成排的支柱对,其中相邻的所述支柱对连结在一起,所述一个或多个锚定件中的每一个在远端处包括末端,并且所述一个或多个锚定件构造成响应于所述框架设置成所述递送构造向内运动并将所述末端设置在相邻的所述支柱对之间。
4.如权利要求2-3中任一项所述的设备,其特征在于,所述根部包括在所述递送构造中相对于所述纵向轴线的角度在-10度至零度之间的曲率部。
5.如权利要求1-3中任一项所述的设备,其特征在于,所述一个或多个锚定件构造成响应于所述框架设置成所述递送构造而在所述腰部处朝向所述纵向轴线旋转。
6.如权利要求5所述的设备,其特征在于,所述腰部包括相对于所述第一主体部分和所述第二主体部分的主体角度,并且所述主体角度有助于所述一个或多个锚定件的响应于所述框架设置成所述递送构造的旋转。
7.如权利要求6所述的设备,其特征在于,在所述展开构造中,所述主体角度小于180°。
8.如权利要求7所述的设备,其特征在于,所述一个或多个锚定件在所述展开构造中的半径小于或等于所述主体角度的半径。
9.如权利要求1-3中任一项所述的设备,其特征在于,所述第二主体部分的柔性小于所述腰部的柔性。
10.一种用于放置在身体中的血管、附属结构和开口中的设备,所述设备具有递送构造和展开构造,所述设备包括:
具有近端、远端和纵向轴线的框架,所述框架由多个支柱形成,所述框架包括:
闭塞面,所述闭塞面布置在所述框架的近端处,所述闭塞面部分地由朝向所述纵向轴线径向延伸的支柱限定;
第一主体部分,所述第一主体部分包括多个单元格并且具有向外弯曲部,
第二主体部分,
腰部,所述腰部设置在所述第一主体部分与所述第二主体部分之间,并且在所述第一主体部分与所述第二主体部分之间形成20度至90度的角度,以及
至少一个锚定件,所述至少一个锚定件具有设置在所述腰部的远端处的根部以及朝向所述近端延伸的末端,并且布置于在所述腰部处会聚的所述框架的相邻的支柱之间并且布置在所述第二主体部分的近侧,
所述至少一个锚定件在所述展开构造中从所述腰部相对于纵向轴线向外突出,并且响应于所述框架设置成递送构造而相对于所述纵向轴线并朝向所述纵向轴线向内运动。
11.如权利要求10所述的设备,其特征在于,所述至少一个锚定件构造成响应于所述框架从所述展开构造设置成所述递送构造而朝向所述纵向轴线旋转。
12.如权利要求10-11中任一项所述的设备,其特征在于,所述至少一个锚定件构造成响应于所述框架从所述递送构造设置成所述展开构造而相对于所述纵向轴线旋转并使锚定件末端向内运动。
13.如权利要求10-11中任一项所述的设备,其特征在于,所述至少一个锚定件中的每一个的根部距所述框架的远端大约为设备总长度的40%。
14.如权利要求10-11中任一项所述的设备,其特征在于,所述第一主体部分的柔性和所述第二主体部分的柔性中的至少一个小于所述腰部的柔性。
15.如权利要求10-11中任一项所述的设备,其特征在于,所述支柱包括与所述锚定件相邻的宽度减小的部分。
16.一种用于在身体的血管、附属结构和开口中展开设备的系统,所述系统包括:
递送导管,所述递送导管具有内腔和基本上圆形的主体部分;以及
具有近端、远端和纵向轴线的框架,所述框架由多个支柱形成,所述框架包括:
闭塞面,所述闭塞面布置在所述框架的近端处,所述闭塞面部分地由朝向所述纵向轴线径向延伸的支柱限定
第一主体部分,其具有从所述闭塞面向远侧延伸的向外弯曲部;
第二主体部分,所述第二主体部分相对于所述纵向轴线朝向所述远端向内渐缩;
腰部,所述腰部设置在所述第一主体部分与所述第二主体部分之间;以及
一个或多个锚定件,所述一个或多个锚定件沿着所述腰部设置,并且在所述第二主体部分的近侧,所述一个或多个锚定件构造成响应于所述框架设置在所述递送导管中而相对于所述纵向轴线并朝向所述纵向轴线向内运动,以避免锚定件末端与所述递送导管之间的接触。
17.如权利要求16所述的系统,其特征在于,所述一个或多个锚定件构造成响应于设置在所述递送导管内而朝向所述纵向轴线旋转而不接触所述基本上圆形的主体部分。
18.如权利要求16-17中任一项所述的系统,其特征在于,所述一个或多个锚定件构造成响应于从所述递送导管展开所述框架而相对于所述纵向轴线向外运动。
19.如权利要求16-17中任一项所述的系统,其特征在于,所述递送导管构造成在展开所述框架的近端之前展开所述框架的远端,并且所述一个或多个锚定件响应于以展开构造从所述递送导管展开所述框架而从所述腰部向外突出并朝向所述近端向上弯曲。
20.如权利要求16-17中任一项所述的系统,其特征在于,所述递送导管构造成响应于将所述框架拉入所述递送导管而从展开构造重新捕获所述框架,并使所述一个或多个锚定件朝向所述纵向轴线旋转。
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