CN110522487A - 动脉瘤装置及递送系统 - Google Patents
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Abstract
本公开题为“动脉瘤装置及递送系统”。本公开涉及一种用于治疗动脉瘤的编织物。所述编织物包括近侧可扩张部分,所述近侧可扩张部分定位于所述动脉瘤内,并且密封穿过所述动脉瘤的颈部。所述编织物还可包括远侧可扩张部分,所述远侧可扩张部分远离所述近侧可扩张部分,所述远侧可扩张部分用于填充所述动脉瘤。
Description
技术领域
本公开涉及医疗器械,更具体地,涉及用于动脉瘤治疗的递送系统。
背景技术
动脉瘤可能是复杂且难以治疗的。例如,当动脉瘤位于关键组织附近时,治疗通路可能受到限制或不可用。由于颅脉管周围的脑组织相应的有限治疗通路,此类因素尤其与颅动脉瘤有关。
现有解决方案包括血管内治疗通路,其中动脉瘤囊的内部体积被移除或排除在动脉血压和血流之外。在这方面,因为动脉瘤的内壁可能继续受到血液流动和相关的压力,所以动脉瘤破裂仍然是可能的。
血管内或其他外科方法的替代方案可包括闭塞装置。这种装置通常具有并入的多个栓塞线圈,这些线圈使用微导管递送系统将其递送到脉管系统。例如,当治疗颅内动脉瘤时,通常首先通过髋部或腹股沟区的股动脉将具有栓塞线圈的递送导管插入非颅血管系统。然后,将导管引导至脑壳内的感兴趣位置。然后,动脉瘤的囊中可以填充有栓塞材料以形成血栓块,所述血栓块保护动脉壁不受血流和相关压力的影响。然而,这种闭塞装置确实存在某些缺点,包括质量效应,这会导致大脑及其神经受到压迫。
一种特定类型的闭塞方法通过将装置植入动脉瘤的载瘤血管中来致力于递送和治疗动脉瘤的入口或“颈部”而不是动脉瘤的体积。在这种“颈部”方法中,通过使穿过颈部的血流量最小化,可以实现进入动脉瘤的流动停止。继而,血栓块可以自然形成,而不必递送栓塞材料至动脉瘤囊,如前所述。该方法比由栓塞材料形成的块更加优选,因为天然块可以通过减少动脉壁可能的扩张来改善愈合,并且允许沿着动脉瘤的颈部平面重新整合到原始载瘤血管形状中。应当理解,颈部平面是一个假想的表面,其中载瘤壁的最内层将是动脉瘤所在的位置。然而,颈部闭塞方法,诸如在载瘤血管中植入阻流装置,并非没有缺点。此类方法可能阻碍血液流入外周血管,同时阻塞载瘤血管中的动脉瘤颈部。如果血管的开口被阻塞,则阻止流向外周血管的流动可能无意中导致严重损坏。
本公开的解决方案解决了本领域的这些和其他问题。
发明内容
在一些实施方案中,本公开涉及用于治疗动脉瘤的自扩张编织物。编织物包括近侧可扩张部分,该近侧可扩张部分定位于动脉瘤内,并且密封穿过动脉瘤的颈部。编织物还包括远侧可扩张部分,该远侧可扩张部分远离近侧可扩张部分,该远侧可扩张部分填充动脉瘤,并且在近侧部分上提供向外的力,以使其保持在动脉瘤中的适当位置。
在一些实施方案中,编织物可以从微导管内的塌缩状态移动到微导管远侧的展开状态。
在一些实施方案中,在展开状态下,近侧可扩张部分形成围绕动脉瘤的颈部密封的环形扩张段,并且远侧可扩张部分形成用于填充动脉瘤的远侧囊。环形扩张段可以由单个连续部分或多个单独的离散部分(例如,从编织物的近侧端部延伸的多个扩张部分)形成。
在一些实施方案中,近侧可扩张部分的孔隙率可小于远侧可扩张部分的孔隙率。相应的孔隙率由间隙、编织角、热处理和覆盖物中的尺寸限定。
在一些实施方案中,远侧囊可以成形为球形、鞍形、椭圆形或任何其他形状。远侧囊也可以是可塌缩的笼状血管闭塞结构。
在一些实施方案中,环形扩张段可以围绕远侧囊的下端形成、倒转并且包围远侧囊的下端。在一些实施方案中,环形扩张段覆盖远侧囊(例如,覆盖远侧囊的外部)。远侧囊的外端或部分可以取向成压靠环形扩张段的内表面。当编织物扩张到展开状态时,远侧囊的外端或部分可以取向成压靠近侧段。当远侧囊压靠环形段时,可以在环形扩张段与远侧囊之间形成空隙或空腔,包括抵靠环形扩张段的内表面。当环形扩张段围绕远侧囊倒转时,也可以在环形扩张段与远侧囊之间形成空隙或空腔。
在一些实施方案中,编织物还包括设置在近侧可扩张部分与远侧可扩张部分之间的锥形段。在这方面,近侧可扩张部分可包括孔隙率低于锥形段和/或远侧可扩张部分的孔隙率。近侧可扩张部分可包括相对于锥形段和/或远侧可扩张部分的编织角的增加的编织角。锥形段还可包括比近侧可扩张部分和/或远侧可扩张部分更少的线段。在这方面,近侧可扩张部分、远侧可扩张部分和/或锥形段可具有不同的编织特性。
在一些实施方案中,带扣部分可包括在编织物中,该带扣部分限定在锥形段与近侧可扩张部分或远侧可扩张部分之间。
在一些实施方案中,编织物具有开放的远侧端部,并且编织物的近侧端部附接到可与递送管可拆卸地连接的锁定部分。
在一些实施方案中,公开了用于治疗动脉瘤的系统。该系统包括微导管、可平移地设置在微导管中的递送管以及本公开的编织物。编织物可以可拆卸地连接到递送管,并且以塌缩状态可滑动地设置在微导管内,并且从微导管内向远侧平移到展开状态。当编织物的远侧端部离开微导管时,编织物(包括远侧可扩张部分和/或近侧可扩张部分)可以扩张到展开状态。
在一些实施方案中,当编织物从微导管向远侧平移并且编织物被推靠在动脉瘤壁上时,环形扩张段覆盖在远侧囊的外部。
在一些实施方案中,该系统可包括不透射线的实体,诸如编织到编织物中的铂丝或用铂拉制的填充的管线,使得该装置可在荧光透视下成像。包括这些实体将允许最终用户理解和可视化编织物相对于动脉瘤的位置。远侧囊和/或环形扩张段的取向和/或位置可通过编织物在微导管中向远侧或向近侧移动来调节。
在一些实施方案中,该系统还包括附接到编织物的近侧端部的锁定部分。在塌缩状态中,锁定部分可以附接到递送管的远侧端部。在展开状态下,锁定部分可以从递送管上拆下,并且编织物可以在动脉瘤中拆下。
在一些实施方案中,还公开了一种用于将闭塞装置递送到动脉瘤的方法。该方法可包括:将编织物的近侧端部附接到递送管的远侧端部;将编织物定位在微导管内;选择性地将带有附接的递送管的编织物定位在脉管系统中(例如在动脉瘤的颈部);通过递送管将编织物从微导管向远侧滑动朝向动脉瘤,从而使动脉瘤内部的远侧可扩张部分扩张,以形成远侧囊,并且在编织物的近侧端部处围绕远侧囊形成环形扩张段;释放编织物,并且从动脉瘤中抽出递送管和微导管。
在一些实施方案中,通过形成所述远侧囊来填充所述动脉瘤。
在一些实施方案中,编织物的选择性定位包括将微导管的远侧端部放置在动脉瘤的颈部。
在一些实施方案中,远侧可扩张部分在环形扩张段形成时同时扩张。
在一些实施方案中,近侧段在远侧段扩张之后扩张。
在一些实施方案中,该方法还包括将锁定部分附接在编织物的近侧端部和递送管的远侧端部;并且通过锁定部分从编织物处释放递送管。
在一些实施方案中,该方法还包括扩张环形扩张段,使得环形扩张段覆盖远侧囊的外表面。
在一些实施方案中,该方法还包括当编织物向远侧平移到动脉瘤中时,将远侧囊的一个或多个外端压靠环形扩张段(例如,环形扩张段的内表面)。
在一些实施方案中,该方法还包括当远侧囊压靠环形扩张段的内表面时,在环形扩张段与远侧囊之间形成空隙或空腔。
在一些实施方案中,该方法还包括当环形扩张段围绕闭塞囊的外表面倒转时,在环形扩张段与远侧囊之间形成空隙或空腔。
在一些实施方案中,该方法还包括在近侧可扩张部分与远侧可扩张部分之间形成锥形段。该方法还可以包括使近侧可扩张部分的孔隙率小于锥形段和/或远侧可扩张部分的孔隙率;将近侧可扩张段定位成与动脉瘤的颈部相邻或连通;以及偏转、转向和/或减慢进入所述动脉瘤的流动。该方法还可以包括使近侧可扩张部分的柔韧性小于锥形段和/或远侧可扩张部分的柔韧性;将近侧可扩张段定位成与动脉瘤的颈部相邻或连通;以及偏转、转向和/或减慢进入所述动脉瘤的流动。在一些实施方案中,远侧囊通过提供血液必须流过的另一个编织层来提供附加的流动转移效果。远侧囊的环形段和近侧端部还可以提供增加的流动转移效果,因为血液必须流过包括微孔的网状结构的附加层(例如,三层)。
在一些实施方案中,公开了一种使用编织物治疗动脉瘤的方法。该方法可包括将编织物定位在动脉瘤内;将编织物向远侧移动到动脉瘤中;将编织物的近侧可扩张部分从塌缩状态扩张到扩张状态,从而密封动脉瘤的颈部;并且在动脉瘤内部扩张编织物的远侧可扩张部分,以形成远侧囊,从而填充动脉瘤。
在一些实施方案中,使编织物的近侧可扩张部分扩张的步骤可包括在编织物的近侧端部处围绕远侧囊形成环形扩张段。
在一些实施方案中,该方法可包括围绕远侧囊的外表面覆盖环形件;并且当编织物扩张到展开状态时,将远侧囊的外端压靠在环形段的内表面上,以将装置固定在动脉瘤壁上。
在一些实施方案中,该方法可包括当远侧囊压靠环形段时,在环形扩张段与远侧囊之间形成空隙或空腔。
在一些实施方案中,该方法可包括在近侧可扩张部分与远侧可扩张部分之间形成锥形段。该方法还可以包括使近侧可扩张部分的孔隙率小于锥形段和/或远侧可扩张部分的孔隙率;以及偏转、转向和/或减慢进入所述动脉瘤的流动。该方法还可以包括使近侧可扩张部分的柔韧性小于锥形段和/或远侧可扩张部分的柔韧性;以及偏转、转向和/或减慢进入所述动脉瘤的流动。
在结合附图查看以下具体描述之后,本公开的其他方面和特征对于本领域普通技术人员将变得显而易见。
附图说明
现在将参考附图,附图不一定按比例绘制。
图1示出了部署到动脉瘤中的本公开的示例闭塞装置。
图2A是具有在微导管内塌缩的闭塞装置的示例性递送系统的示意性侧视图。
图2B是具有在微导管内远侧部署的闭塞装置的示例性递送系统的示意性侧视图。
图3是图1至图2所示处于扩张状态的编织物的放大示意性侧视图。
图4是本发明的编织物的另一实施方案的放大示意性侧视图。
图5A是在编织物被推入示例动脉瘤中时图1至图3的递送系统和编织物的放大示意性侧视图。
图5B是在编织物被推入示例动脉瘤中时图1至图3的递送系统和编织物的放大示意性侧视图。
图6A是在编织物被推入示例动脉瘤中时图1至图3的递送系统和编织物的放大示意性侧视图。
图6B是在编织物被推入示例动脉瘤中时图1至图3的递送系统和编织物的放大示意性侧视图。
图7A为示出与示例闭塞装置一起使用的示例性递送系统的透视示意图。
图7B为图7A的透视示意图,但是具有递送系统和闭塞装置的部分横截面。
图8A为图7A至图7B的透视示意图,部署有递送系统和闭塞装置的部分横截面。
图8B为图7A至图7B的透视示意图,部署有与闭塞装置分离的示例性递送系统。
图9为递送闭塞装置的方法的流程图。
图10为递送闭塞装置的方法的流程图。
具体实施方式
尽管本文详细解释了所公开技术的示例实施方案,但是应当理解可以设想其他实施方案。因此,并不意图将所公开技术的范围限制在以下描述中阐述的或附图中所示的部件的构造和布置的细节。所公开技术能够具有其他实施方案并且能够以各种方式实践或实施。
还应该注意的是,除非上下文清楚地指明,否则本说明书和所附权利要求中所用的单数形式“一个/一种”和“所述/该”包括复数指代物。所谓“包含”或“含有”或“包括”是指至少命名的化合物、元素、颗粒或方法步骤存在于组合物或制品或方法中,但不排除存在其他化合物、材料、颗粒、方法步骤,即使其他此类化合物、材料、颗粒、方法步骤具有与命名的那些相同的功能。
在描述示例实施方案时,为了清楚起见,将采用术语。旨在使每个术语设想其本领域技术人员理解的最广泛的含义,并且包括以类似方式操作以实现类似目的的所有技术等同物。还应当理解,提到方法的一个或多个步骤不排除存在附加的方法步骤或在那些明确标识的步骤之间的中间方法步骤。在不脱离所公开技术的范围的情况下,可以与本文所述的顺序不同的顺序执行方法的步骤。类似地,还应当理解,提到装置或系统中的一个或多个部件不排除存在附加的部件或在那些明确标识的部件之间的中间部件。
如本文所讨论的,脉管系统可以是任何“受试者”或“患者”(包括任何人或动物)的脉管系统。应当理解,动物可以是各种任何适用的类型,包括但不限于哺乳动物、兽医动物、家畜动物或宠物类动物等。例如,动物可以是专门选择具有与人类相似的某些特征的实验动物(例如,大鼠、狗、猪、猴等)。应当理解,受试者可以是例如任何适用的人类患者。
如本文所讨论的,“操作者”可包括医生、外科医生或者与将编织体递送到受试者的脉管系统相关联的任何其他个体或递送仪器。
相关地,横跨动脉瘤颈部署的血流导向装置可改变血液进入动脉瘤的流动。示例性血流导向装置可以是具有相对较低孔隙率的编织装置。随着时间的推移,动脉瘤可通过以高成功率密封动脉瘤颈来治愈。然而,血流导向技术并非没有限制。挑战包括由于血管形态、血管扭曲或编织错位而在血管内放置装置。此外,接受血流导向装置的患者必须长时间使用抗凝药物以防止血管血栓形成。血管内装置还旨在切断动脉瘤中的循环,同时最小化血管中的金属量并显著减少或消除对凝血药物的需要。这些类型的装置也可更易于在病变部位跟踪和/或部署。
本文公开的装置和系统通过使用单个装置密封动脉瘤颈部,在动脉瘤而不是载瘤血管中来解决先前方法的这些和其他缺点。转到图1,本公开的示例编织物10被示出为部署在血管BV的动脉瘤A中但尚未从递送系统40释放。递送系统40可包括递送管30可滑动地设置在其中的微导管20。如图1所示,编织物10可以由递送管30从微导管20内的塌缩状态移动到微导管20远侧的展开状态。递送管30的远侧端部34可以通过锁定部分54附接到编织物10的近侧端部16,如下文更具体地描述的。
在图1中,微导管20已经被递送到动脉瘤A的颈部,并且由编织物10的远侧可扩张部分12形成的远侧囊被示出为填充动脉瘤A。部分12可以从远侧囊径向扩张成预先确定的形状和结构,该形状和结构描画动脉瘤A的壁的轮廓并支撑动脉瘤A的壁。例如,部分12的远侧囊可以成形为球形、鞍形、椭圆形或任何其他形状。部分12的远侧囊也可以是可塌缩的笼状血管闭塞结构。还示出了由近侧可扩张部分13形成的环形扩张段3,部分13在部分12的近侧。可以在动脉瘤A的颈部周围形成段3。在一些实施方案中,段3可以用于定位在动脉瘤A的颈部内并密封。段3可以由单个连续部分(例如,单个整体形成的网)或多个单独的离散部分(例如,多个离散部分能够从编织物10的近侧端部16扩张和延伸)形成。
当移动到展开状态时,部分13可以扩张并形成围绕和/或包围远侧囊部分12的下近侧端部的环形扩张段3。例如,环形扩张段3可以围绕和/或包围锥形段5形成,该锥形段可以定位在部分12与13之间。尽管仅示出了部分12和13与锥形段5互连,但是根据需要或要求可以包括任何数量的附加可扩张部分和/或段。编织物10由可由网形成的多个自扩张多细丝段形成。编织物10还可以包括带扣部分,用于促进部分12和/或13从动脉瘤内部的塌缩状态扩张到展开状态。一个或多个带扣部分可定位在部分12与13之间,包括在锥形段5上或其周围。编织物10还可以具有与段12相关联的开放远侧端部14,以及与段13相关联的近侧端部16,该近侧端部旨在定位在动脉瘤A的颈部上或其附近。端部16也可以附接到锁定部分54,该锁定部分被配置为与递送管30的远侧端部34可释放地附接。
编织物10的网可以由一个或多个网图案、一个或多个离散网部分(包括部分12和13和/或锥形段5)和/或由编织细丝限定的一个或多个网开口限定。例如,编织物10的网可包括与部分12的远侧囊相关联的孔隙区域,以及与部分13的段3相关联的另一个孔隙区域。在一些实施方案中,部分12的孔隙率可小于部分13的孔隙率。然而,编织物10不限于此,编织物10的其他部分可以具有其孔隙率,并且其他编织性能根据需要或要求而变化。例如,部分13可包括低于锥形段5的孔隙率的孔隙率。编织物10的各个部分的相应孔隙率可以通过改变间隙、编织角、热处理、网开口、覆盖物和/或等的尺寸来限定。例如,图1至图2B中所示的编织物10的网可包括与每个段12、13相关联的不同孔隙度区域。在实践中,部分12的孔隙率可允许其外部远侧囊在递送至动脉瘤之前、期间或之后呈现多种形状。
在一些实施方案中,段3可以在展开状态下覆盖部分12的远侧囊。例如,当编织物10通过递送管30从微导管20向远侧平移时,段3可以覆盖部分12的远侧囊的外表面。当编织物10被推靠在动脉瘤壁上时,也可能发生部分12和13的扩张。当编织物10扩张到展开状态时,部分12的远侧囊的外端也可以取向成压靠环形扩张段3。示例性的“按压”在图1所示的取向中示出,由此当段12压靠在部分3的环形段的内表面上时,段3与远侧囊之间可形成空隙或空腔9。该空隙或空腔9可用作“气垫”,使得当将编织物朝远侧推动到动脉瘤A中时,由于部分12和13被推入另一个并且柔性地适形于动脉瘤A的形状而具有一定的给予量,因此避免了破裂。
编织物10的网可以包括管,其近侧端部16在相对的远侧端部14处开口。近侧端部16也可以闭合并附接到锁定部分54。编织物10可以由几种材料制成,诸如沉积的薄膜或单一材料。编织物10的网可包括多根线,例如4至96根线。线的数量可以是控制编织物10的材料特性的因素,包括孔隙率、展开状态下的形状、柔韧性、刚度等。当确定编织物10的网的线数时,可以考虑部分12的远侧囊与外部覆盖的环形扩张段3的组合,因为囊在展开状态下基本上位于环形扩张段3内部。此外,段12的远侧囊和/或部分13的环形扩张段3可以一起是可塌缩的笼状血管闭塞结构。
编织物10的线可由具有用于射线不透性的交织铂丝的镍钛诺或具有10%至40%铂的拉伸填充管(DFT)镍钛诺制成。线可由镍钛合金、钴铬合金、不锈钢、钽和/或其他合金和/或任何其他合适的生物相容材料或这些材料的组合制成。而且,这些材料可随着时间的推移被患者吸收或不可被患者吸收。在这方面,与部分12相关联的第一孔隙率可小于部分13的孔隙率。将段12、13布置成展开状态、改变编织特性,并且/或者将段12定位成与动脉瘤的颈部相邻或连通,可有利于翻转、倒转和/或减慢进入动脉瘤的流动。
整个编织物10的网的孔也可形成基本一体的框架或网。因此,孔可为任何尺寸、形状或孔隙度,并且可在整个编织物10的网壁内均匀或随机地间隔开。孔可提供具有柔韧性的编织物10,并且还有助于网从塌缩状态转换到扩张的展开状态,反之亦然。
在某些实施方案中,部分12、13或锥形段5中的一个或一些的编织角也可以变化。编织物10的线直径、经纬密度(即,每个线性测量的线交叉数量)也可在编织物10的位置之间变化或以其他方式修改,以改变装置特征以及热定形形状。编织物10的纤维可通过经由热粘结(通过激光或超声波焊接)、溶剂或粘合剂粘结、卷边或任何其他附接方式在其自由端进行固定而形成。编织物10的纤维可通过溶剂、粘合剂或热粘结(如激光、超声波焊接或任何其他热源)在其内部交叉点处进行粘结。然而,编织物10并不限于此并且其可具有编织角、节距数、线直径、孔隙度或编织物10的始终基本相似的任何其他特性。
转到图2A,示例编织物10在微导管20内处于塌缩状态,并且在布置有动脉瘤A之前连接到递送管30。图2B描绘了图2A的编织物10,其连接到递送管30并且布置在微导管20的远侧的展开状态。递送系统40可包括递送管30可滑动地设置在其中的微导管20。微导管20可预先放置在动脉瘤颈部的水平处,并用于跟踪装置到动脉瘤。微导管20的尺寸可考虑动脉瘤或微导管20必须通过以到达治疗部位的特征部的尺寸、形状和方向性来选择。微导管20可在任何地方具有80厘米至170厘米的总可用长度。微导管20可在任何地方具有0.015英寸与0.032英寸之间的内径ID。外径OD的尺寸也可变化并且可在其近侧端部或远侧端部处变窄。在其近侧端部26处,微导管20可用手操作,并且在其远侧端部24处可以可操作以定位在动脉瘤A的颈部。而如图所示的微导管20的远侧端部24包含编织物10,端部24可变化形状并且可以一定角度弯曲。
递送管30可以是基本细长的,并且可从微导管20的近侧端部26延伸到远侧端部24。管30通常可沿微导管20的内腔延伸,并且可在其外表面和微导管20的内表面之间留有空间。继而,递送管30和微导管20可轴向对齐。系统40可使用微导管20将编织物10递送到感兴趣位置(例如,病变部位)。在某些实施方案中,微导管20可预先放置在动脉瘤颈部的水平处并且用于例如通过跟踪与锁定部分54相关联的不透射线元件来跟踪编织物10到病灶。递送管30可在锁定部分54处与编织物10机械连接。如下文更具体地所示,锁定部分54可包括推动器环。
编织物10可通过可滑动附接件、永久附接件(例如,卷曲、激光、超声焊接或其他热源、粘合剂等)或其他附接方法附接到锁定部分54,如下文更具体地描述的。当递送管30在锁定部分54处附接到编织物10时,朝向动脉瘤A朝远侧平移、滑动或以其他方式移动管30可使编织物10开始从微导管20内的塌缩状态移动到具有形成的部分12的远侧囊、部分13的环形扩张段3和/或设置在它们之间的锥形段5的微导管20外部的展开状态。
如图2B所示,现在形成相应的部分12的囊,并且部分13的环形扩张部分3设置在部分12的近侧和外侧覆盖。近侧端部16仍然经由锁定部分30连接到递送管54。在图2B中,远侧端部14可以形成部分12的远侧囊的外层,而近侧端部16可以形成部分13的环形扩张段3的外层。
转到图3,图1至图2B的编织物10的放大示意性侧视图以特写的扩张状态示出。如图所示,部分12已经扩张成大致球形的远侧囊以及通向部分13的环形扩张段3的近侧锥形圆锥段5。与部分12、13和/或锥形段5相关联的编织物的网特性包括孔隙率和柔韧性,它们可以变化,其中孔隙率最低,柔韧性最大,优选地在动脉瘤颈部的部分13处。例如,因为部分12和13的展开形状在动脉瘤A内形成它们各自的预先确定的形状(参见例如,部分12的远侧囊),因此在近侧端部16上或其附近的编织物10的部分(例如部分13)可以比在近侧端部14上或其附近的编织物10的部分(例如部分12)更柔韧,以便在递送期间诱导自我扩张。然而,编织物10不限于此,并且可以根据需要或部分12、13和/或段5使用柔韧性和/或孔隙率的任何组合。编织物10的其他孔隙度区域中的细丝在其整个长度上也可具有恒定的经纬密度。
编织物10可由具有用于射线不透性的交织铂丝的镍钛合金制成。当装置10完全展开在动脉瘤A中时,部分12与13之间的锥形段5可以允许相应的部分扩张,以形成部分12的远侧,并且包围部分13的环形扩张段3。为了促进编织物10的扩张和/或部分13的环形扩张段的形成,编织物10可以被修改为在段5处被削弱,以促进段13围绕段12的倒转。例如,段5可包括预弱化部分,该部分包括局部编织角变化、线段的移除、局部热处理和/或改变编织物特性的其他方法。在某些实施方案中,部分13的编织角可以相对于编织物10的其他部分(包括部分12)减小,使得流动可以偏转、转向和/或减慢到动脉瘤中。这是因为当部分12和/或13在动脉瘤A中扩张并且编织物10在动脉瘤A中展开时,部分13可以被配置用于与动脉瘤A的颈部连通,因为端部16可以在递送期间被塞入部分13中(例如,参见图6A)。
编织物10的直径和编织线数可根据治疗特定动脉瘤所需的装置的直径和/或所需的孔隙率而变化。例如,为了诱导部分12的远侧囊和部分13的环形扩张段3的预先确定形状和强度的形成,端部14可以比端部16更柔韧,或者反之亦然,并且编织物10的其他位置(例如,锥形段5)可以从端部16上或在该端部附近变得最柔韧,并且在端部14上或在该端部附近变得较不柔韧。在一些实施方案中,14的编织线端部可以彼此环绕,这尤其有利于确保编织物10在与动脉瘤A的圆顶接触时是无创伤的。
为了形成或组装如图1至图3所示的编织物10,锁定部分54可以连接到端部16和/或折叠在该端部上。编织物10不限于此,并且端部16可通过声波焊接、机械附接或粘合剂可操作地连接锁定部分54或其任何特征。无论连接如何,近侧端部16可操作地连接到锁定部分54可使得形成与段12相关联的编织物10的外层。
图4是在与微导管20和递送管30组装之前的替代编织物10a的放大示意性侧视图。在该实施方案中,编织物10a可包括另选部分12a,其具有与中心设置的段5a和部分13相对的开放或封闭的远侧端部14a。如图所示的部分12a可以是简单的管状和/或圆柱形截面,其被设计成以类似于线圈的方式扩张并占据动脉瘤A内部的空间。部分12a与13的网特征之间的差异是可见的。还可以看出,该实施方案中的部分13的段3可以包括无创伤外端,该无创伤外端被配置为在递送期间扩张并压靠动脉瘤壁而没有破坏动脉瘤的风险。锁定部分54也可以设置在编织物10a的近侧端部16处,并且包括不透射线的元件,以便于精确跟踪病变部位。在所示实施方案中所描绘的部分12a和13的曲折形状仅仅是示例性的,并且可以根据需要或要求使用包括部分12a和13的编织物10a的任何特征的任何形状。
在实践中,如图5A至图6B所示,编织物10可以通过递送管30推入动脉瘤A中,并且与部分13的较低孔隙率外层一起展开穿过动脉瘤A的颈部。在图5A的布置之前,编织物10可以与处于塌缩状态的递送管30和/或微导管20组装在一起,并因此设置在微导管20内部。在这方面,递送系统40和编织物10可包装为便携式试剂盒或系统。微导管20、递送管30和/或编织物10之间的组装可在被引入脉管之前进行。与编织物10一起使用的递送系统40可包括微导管20和递送管30,可选择性地定位在病变部位,并且递送管30可开始向动脉瘤朝远侧平移编织物10。
在图5A中,递送管30具有向远侧平移的编织物10进入动脉瘤A。部分12已经开始朝向动脉瘤A的外壁径向扩张,而未扩张部分13离开微导管20并且在颈部处或颈部附近插入动脉瘤A内部。另外,在端部16处或其附近的编织物10的部分在微导管20内部塌缩。可以看到图5A中的环形扩张段3开始从其中心轴向外朝向动脉瘤A的壁向外扩张,而部分12的远侧囊在段3的远侧扩张。段5在图5A中示出为处于其预扩张状态的基本管状。然而,在图5B中,当递送管30向远侧更深地移动到动脉瘤A中时,部分12的远侧囊和环形扩张段3继续围绕段5和远侧囊12扩张和倒转。。在图5A至5B之间的移动,示出了段3围绕和/或包围部分12的远侧囊的下端形成。还示出了段3覆盖部分12的远侧囊,因为编织物10向远侧更深地平移到动脉瘤中,并且编织物10的端部14被推靠在动脉瘤壁上。当编织物10向远侧倾平移深时,在图5B中可以看出,段12的外端开始压靠环形段3。
转到图6A,由于段3围绕段5倒转,在段3与远侧囊之间形成了空隙或空腔9。该空隙或空腔9可以用作进一步防止破裂的“气垫”。锁定部分54被描绘为靠近或邻近微导管20的端部24,使得编织物10的所有部分都在其远侧并且在微导管20的外部。因此,段3已经完全扩张,其远侧端部被压入远侧囊中。段3的近侧表面可以是弯曲的或具有轮廓,以与动脉瘤A的颈部连通并且用作偏流元件。应当理解,编织物10可由具有用于射线不透性的交织铂丝的镍钛合金制成。递送管30可由操作者等通过海波管从其近侧端部36驱动。在递送期间,微导管20可保持相对静止或固定,而可以看出递送管30朝动脉瘤A的颈部并穿过该颈部朝远侧平移编织物10。如图6A所示,递送管30的进一步远侧平移可以基本上使得锁定部分54的段5的锥角更大,并且段3围绕部分12和/或量段3的扩张被压靠在那里。继而,部分54基本上塞入编织物10中,从而使相对于动脉瘤的颈部变平或以其他方式呈现更具轮廓的段3。
还可看到在图5A至图6A之间移动,编织物10的端部16、锁定部分54和递送管30之间的连接部可在塌缩状态下从微导管20内移动到完全处于展开状态的动脉瘤A内。一旦编织物10被选择性地定位,包括处于其展开状态的部分12和13,编织物10可以从递送管30拆下,如图6B所示。换句话讲,当编织物10向动脉瘤A的圆顶朝远侧平移时,部分12、13可扩张,以容易、有效且避免破裂风险的方式支撑动脉瘤壁。
一旦扩张和定位,递送管30可朝近侧平移回微导管20并从编织物10和动脉瘤A缩回。图6B示出编织物10在其展开状态下的示例性布置,并且部分12和13分别移动到其展开构型并且将锁定部分54从递送管30拆下。将部分12、13和/或锁定部分54扩张到编织物10中是特别有利的,因为它可以防止编织物10产生突起,否则该突起将延伸到载瘤血管中。相反,任何此类突起现在可被塞入编织物10中。以这种方式跨动脉瘤的颈部布置编织物10同时还改变部分12、13的孔隙率还可在编织物10的囊内形成血流导向。图6B仅示出了部分12的示例球形远侧囊和示例环形扩张段3,其以足以闭塞动脉瘤A的方式完全形成。然而,如果部分12或13均未被精确定位或需要在动脉瘤A内重置或调整以进行安全闭塞而不产生破裂的风险,则可在仍附接到编织物10时,通过朝近侧抽出递送管30将编织物10回缩到微导管20中。
图7A至图8B总体上示出了递送管30与编织物10之间的示例附接和递送,用于在动脉瘤A中展开和拆下编织物10。图7A至图8B的实施方案仅仅是递送管30和编织物10可以在端部34处附接的一种方式,并且根据需要或要求可以设想任何数量的附接手段。如图所示的递送管30可具有从近侧端部36延伸到远侧递送端部34的腔体。图7A示出了与锁定构件52接合的编织物10和锁入锁定部分54的环线58。可穿过锁定部分54放置环线58的开口60。锁定部分54优选地采用小直径细长细丝的形式,然而,例如线或管状结构等其他形式也可以是合适的。虽然锁定部分54优选地由镍钛诺形成,但例如不锈钢、PTFE、尼龙、陶瓷或玻璃纤维及复合物等其他金属和材料也可以是合适的。在一个示例中,锁定构件52可为细长的可回缩纤维,其可在微导管20的端部24和端部26之间延伸。锁定构件52优选地采用小直径细长细丝的形式,然而,例如线或管状结构等其他形式也可以是合适的。虽然锁定构件52优选地由镍钛诺形成,但例如不锈钢、PTFE、尼龙、陶瓷或玻璃纤维及复合物等其他金属和材料也可以是合适的。当锁定构件52穿过开口60时,编织物10现在是固定的。应当理解,递送管30可包括设置在其端部34和端部36之间的可压缩部分38。
可压缩部分38可允许递送管30弯曲和/或挠曲。这种柔韧性可帮助通过微导管20跟踪编织物10和通过脉管系统的曲折路径。可压缩部分38可形成有干涉螺旋切口,该干涉螺旋切口可允许有间隙以允许弯曲,但是在一个示例中,不用作螺旋切割弹簧。可压缩部分38可在伸长状态和压缩状态之间轴向调节。然而,允许轴向调节的任何其他布置(例如,缠绕线或螺旋带)也可适合与根据本公开的分离系统一起使用。除非另有限制,否则可压缩部分38在静止时可处于伸长状态并且从压缩状态自动地或弹性地返回到伸长状态。本文更详细地描述了可压缩部分38的功能。
在图7A中,预先施加力F以将递送管30置于压缩状态。图7B示出了朝近侧拉动锁定构件52以开始编织物10的释放序列。图8A示出了锁定构件52离开开口60并被拉出环线58的瞬间。环线58的远侧端部62脱离/返回其预成形形状并离开锁定部分54。可以看出,现在没有任何东西将编织物10保持到递送管30。图8B示出了释放序列的结束。在此,递送管30的可压缩部分38已经膨胀/恢复到其原始形状并且向前“弹出”。由递送管30的远侧端部34向编织物10施加弹力E以将其“推动”离开,以确保清洁分离并将编织物10递送到动脉瘤A。应当理解,图7A至图8B中描述的递送方案仅是递送编织物10的示例方法。
图9是将闭塞装置递送到动脉瘤的方法900的流程图。步骤905包括将编织物的近侧端部附接到递送管的远侧端部。步骤910包括选择性地将微导管定位在脉管系统中(例如,在动脉瘤的颈部)。步骤915包括将编织物与附接的递送管定位在微导管中。步骤920包括通过递送管将编织物从微导管向远侧滑动朝向动脉瘤,从而使动脉瘤内部的远侧可扩张部分扩张,以形成远侧囊,并且在编织物的近侧端部处围绕远侧囊形成环形扩张段。步骤925包括释放编织物,其可包括环形扩张段和远侧囊。步骤930包括从动脉瘤中取出递送管和微导管。
在某些实施方案中,方法900还可包括通过形成远侧囊来填充动脉瘤。在一些实施方案中,编织物的选择性定位包括将微导管的远侧端部放置在动脉瘤的颈部。在一些实施方案中,远侧可扩张部分在环形扩张段形成时同时扩张。
在某些实施方案中,方法900还包括将锁定部分附接在编织物的近侧端部和递送管的远侧端部;并且通过锁定部分从编织物处释放递送管。在某些实施方案中,方法900还包括扩张环形扩张段,使得环形扩张段覆盖远侧囊的外表面。在某些实施方案中,方法900还包括当编织物向远侧平移到动脉瘤中时,将远侧囊的一个或多个外端压靠环形扩张段。在某些实施方案中,方法900包括当环形扩张段围绕远侧囊倒转时,在环形扩张段与远侧囊之间形成空隙或空腔在某些实施方案中,方法900包括在近侧可扩张部分与远侧可扩张部分之间形成锥形段。
在某些实施方案中,方法900还包括使近侧可扩张部分的孔隙率小于锥形段和/或远侧可扩张部分的孔隙率;将近侧可扩张段定位成与动脉瘤的颈部相邻或连通;以及偏转、转向和/或减慢进入动脉瘤的流动。该方法900还可以包括使近侧可扩张部分的柔韧性小于锥形段和/或远侧可扩张部分的柔韧性;将近侧可扩张段定位成与动脉瘤的颈部相邻或连通;以及偏转、转向和/或减慢进入动脉瘤的流动。
在一些实施方案中,公开了一种使用编织物治疗动脉瘤的方法1000。步骤1005可包括将编织物向远侧移动到动脉瘤中。步骤1010可包括将编织物的近侧可扩张部分从塌缩状态扩张到扩张状态,从而密封动脉瘤的颈部。步骤1015可包括在动脉瘤内部扩张编织物的远侧可扩张部分,以形成远侧囊,从而填充动脉瘤。
在某些实施方案中,步骤1015可包括在编织物的近侧端部处围绕远侧囊形成环形扩张段。在一些实施方案中,方法1000可包括使环形扩张段围绕远侧囊的外表面重叠和倒转。在一些实施方案中,方法1000可包括当环形扩张段围绕远侧囊倒转时,在环形扩张段与远侧囊之间形成空隙或空腔在一些实施方案中,方法1000可包括在近侧可扩张部分与远侧可扩张部分之间形成锥形段。方法1000还可以包括使近侧可扩张部分的孔隙率小于锥形段和/或远侧可扩张部分的孔隙率;以及偏转、转向和/或减慢进入动脉瘤的流动。该方法1000还可以包括使近侧可扩张部分的柔韧性小于锥形段和/或远侧可扩张部分的柔韧性;以及偏转、转向和/或减慢进入动脉瘤的流动。
应当理解,编织物10的变型可包括各种材料,诸如不锈钢、生物可吸收材料和聚合物。编织物10,包括任何特定部分,诸如任何断裂、不同孔隙率的不同区域和闭塞囊,可以热定形成各种构型,诸如球形、椭圆形、鞍形等,用于使远侧囊和/或其他扩张段成形,以更好地匹配动脉瘤形态。另外,编织物10可以被热成形为包括薄弱点,以有利于远侧囊和/或其他扩张段的径向扩张。此外,形成远侧囊和/或其他扩张段的编织物10的间隙可以变化,或者可沿其长度选择性地设计尺寸或形状,这取决于随着递送管30朝远侧移动而使编织物10扩张多少。
应当理解,编织物10还可以包括在系统中或以其他方式与成像装置连通,该成像装置能够使编织物10的远侧囊和/或其他扩张段相对于动脉瘤成像。通过编织物10相对于动脉瘤向远侧或近侧移动,并且由成像装置通过编织物的一个或多个不透射线的特征或附接到其上精确地监测,远侧囊和/或其他扩张段的取向可以是可调节的。
具体的构型、材料的选择以及各种元件的尺寸和形状可以根据需要根据所公开技术的原理构造的系统或方法的特定的设计规格或约束而变化。这些改变旨在包含在所公开技术的范围内。因此,本发明所公开的实施方案在所有方面都被认为是例示性的而非限制性的。因此,从前述内容显而易见的是,虽然已经示出和描述了本公开的特定形式,但是在不脱离本发明的精神和范围的情况下,可以进行各种修改,并且在其等同物的含义和范围内的所有改变都旨在包含在其中。
Claims (20)
1. 一种用于阻塞动脉瘤的编织物,所述编织物包括:
近侧可扩张部分,所述近侧可扩张部分定位于所述动脉瘤内,并且密封穿过所述动脉瘤的颈部;和
远侧可扩张部分,所述远侧可扩张部分远离所述近侧可扩张部分,所述远侧可扩张部分填充所述动脉瘤,并且在所述近侧部分上提供向外的力,以使其保持在所述动脉瘤中的适当位置。
2.根据权利要求1所述的编织物,其中在展开状态下,所述近侧可扩张部分形成围绕所述动脉瘤的所述颈部密封的环形扩张段,并且所述远侧可扩张部分形成填充所述动脉瘤的远侧囊。
3.根据权利要求2所述的编织物,其中所述环形扩张段围绕所述远侧囊的下端形成、倒转并且包围所述远侧囊的下端。
4.根据权利要求2所述的编织物,其中所述近侧可扩张部分的孔隙率小于所述远侧可扩张部分的孔隙率。
5.根据权利要求4所述的编织物,其中所述相应的孔隙率由间隙、编织角、热处理和覆盖物中的至少一个的尺寸限定。
6.根据权利要求2所述的编织物,其中所述环形扩张段覆盖在所述远侧囊的外部,由此当所述编织物扩张到所述展开状态时,所述远侧囊的外部能够压靠所述环形扩张段的内表面。
7.根据权利要求6所述的编织物,其中当所述环形扩张段围绕所述远侧囊倒转时,在所述环形扩张段与所述远侧囊之间形成空隙或空腔。
8.根据权利要求2所述的编织物,还包括设置在所述近侧可扩张部分与所述远侧可扩张部分之间的锥形段。
9.根据权利要求8所述的编织物,其中所述近侧可扩张部分的孔隙率低于所述锥形段和所述远侧可扩张部分的孔隙率。
10.根据权利要求8所述的编织物,还包括带扣部分,所述带扣部分限定在所述锥形段与所述近侧可扩张部分或所述远侧可扩张部分之间。
11.一种治疗动脉瘤的系统,所述系统包括:
微导管;
递送管,所述递送管可平移地设置在所述微导管中;和
编织物,所述编织物根据权利要求2所述,所述编织物可拆卸地连接到所述递送管,并且以塌缩状态可滑动地设置在所述微导管内,并且从所述微导管内向远侧平移到展开状态;
其中当所述编织物的所述远侧端部离开所述微导管时,所述编织物,包括远侧可扩张部分和近侧可扩张部分中的至少一者,扩张到所述展开状态。
12.根据权利要求11所述的系统,其中当所述编织物从所述微导管向远侧平移并且所述编织物被推靠在所述动脉瘤壁上时,所述环形扩张段覆盖在所述远侧囊的外部。
13.一种用于将闭塞装置递送到动脉瘤的方法,包括:
将所述编织物的近侧端部附接到递送管的远侧端部;
将编织物定位在微导管内;
选择性地将所述编织物与所述递送管一起定位在所述脉管系统中;
通过所述递送管使所述编织物从所述微导管朝向所述动脉瘤远侧滑动,从而使所述动脉瘤内部的远侧可扩张部分扩张以形成远侧囊;以及
在所述编织物的近侧端部处通过倒转而围绕所述闭塞囊形成环形扩张段;
释放所述编织物。
14.根据权利要求13所述的方法,还包括:
将所述编织物定位在微导管内;
将所述编织物的近侧端部附接到递送管的远侧端部;以及
通过形成所述远侧囊来填充所述动脉瘤。
15. 根据权利要求13所述的方法,还包括:
在所述编织物的所述近侧端部和所述递送管的所述远侧端部处将锁定部分附接到所述递送管;以及
通过所述锁定部分从所述编织物处释放所述递送管。
16.根据权利要求13所述的方法,还包括:
扩张所述环形扩张段,使得所述环形扩张段覆盖所述远侧囊的外表面。
17.根据权利要求16所述的方法,还包括:
当所述编织物向远侧平移到所述动脉瘤中时,将所述远侧囊的所述外表面的一个或多个外端压靠在所述环形扩张段上。
18.根据权利要求17所述的方法,还包括:
当所述环形扩张段围绕所述闭塞囊的所述外表面倒转时,在所述环形扩张段与所述远侧囊之间形成空隙或空腔中的至少一者。
19.根据权利要求13所述的方法,还包括:
使所述近侧可扩张部分的孔隙率小于所述近侧可扩张部分与所述远侧可扩张部分之间的锥形段中的至少一者的孔隙率;
将所述近侧可扩张段定位成与所述动脉瘤的颈部相邻或连通;以及
偏转、转向或减慢进入所述动脉瘤的流动。
20.一种闭塞动脉瘤的方法,包括:
将所述编织物向远侧移动到所述动脉瘤中;
将所述编织物的近侧可扩张部分从塌缩状态扩张到扩张状态,从而密封所述动脉瘤的颈部;以及
在所述动脉瘤内部扩张所述编织物的远侧可扩张部分,以形成远侧囊,从而填充所述动脉瘤。
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