CN112914656A - 具有高度柔性填充材料的囊内翻转编织物 - Google Patents
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Abstract
本发明题为“具有高度柔性填充材料的囊内翻转编织物”。本发明提供了一种管状编织植入物,该管状编织植入物包括编织物,该编织物可作为单层编织物递送,在部署期间向内翻转以形成至少两个嵌套的囊,并且包括可填充最内层囊的附加编织材料。该附加编织物材料可像带状物一样成环或盘绕和/或翻转以形成越来越小的嵌套囊。该编织物可沿其长度具有可变的编织角,使得当被定位以用于递送时,该编织物可在其远侧端部附近具有高编织角并且在近侧端部附近具有低编织角。除此之外或作为填充最内层囊的编织物材料的替代物,该植入物可包括可在最内层囊内成环的栓塞性线圈。
Description
技术领域
本发明整体涉及医疗器械,并且更具体地涉及用于动脉瘤治疗的栓塞性植入物。
背景技术
颅内动脉瘤可为复杂的并且可因其靠近关键脑组织而难以治疗。现有解决方案包括血管内治疗,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。血管内或其它外科手术方法的当前另选方案可包括在血管内递送的治疗装置,该治疗装置利用栓塞性材料填充动脉瘤的囊或者阻塞动脉瘤的入口或颈部。这两种方式均试图阻止血液流入动脉瘤内。当填充动脉瘤囊时,栓塞性材料使血液凝块,从而在动脉瘤内产生血栓块。当治疗动脉瘤颈部时,进入动脉瘤入口的血流被禁止,从而诱导动脉瘤中的静脉停滞并促进动脉瘤内的血栓块的自然形成。
当前的血管内递送装置通常利用多个栓塞性线圈来填充囊或治疗动脉瘤的入口。与利用栓塞性线圈填充的动脉瘤块相比,通过利用栓塞性线圈治疗入口而形成的自然形成的血栓块可导致改善愈合,因为自然形成的血栓块可降低从动脉壁的扩张的可能性并且有助于沿着颈部平面重新结合到原始载瘤血管形状中。然而,递送到动脉瘤颈部的栓塞性线圈可能具有阻碍相邻血管中的血液流动的不利影响,特别是在入口处过度填充的情况下。相反,如果入口未被充分填充,则血流可以持续进入动脉瘤中。治疗某些动脉瘤形态(例如,宽颈部、分叉等)可需要辅助装置(诸如支架或球囊)来支撑线圈质量并获得期望的堆积密度。一旦植入,线圈就不容易回缩或重新定位。此外,栓塞性线圈并不能总是有效地治疗动脉瘤,因为利用多个线圈治疗的动脉瘤通常因卷曲不良、缺乏横跨动脉瘤颈部的覆盖、血流或较大的动脉瘤尺寸而再通或压缩。
正在探索栓塞性线圈的替代方案,例如管状编织植入物公开于美国专利公布号2018/0242979中,该专利公布以引用方式并入本文。管状编织植入物有可能轻松、准确且安全地治疗载瘤血管中的动脉瘤或其它动静脉畸形,同时不会阻塞流入与载瘤血管连通的穿支血管的血流。然而,与栓塞性线圈相比,管状编织植入物是较新的技术,因此对于管状编织植入物,具有改善几何形状、构型、递送系统等的能力。
因此,需要针对用于动脉瘤治疗的植入物的改善的方法、装置和系统。
发明内容
本发明的目的是提供满足上述需求的系统、装置和方法。总体上,本发明的目的是提供管状编织植入物,该管状编织植入物包括可作为单层编织物递送的编织物,该编织物可在部署期间向内翻转以形成至少两个嵌套的囊,并且可包括可填充最内层囊的附加编织材料。该附加编织物材料可像带状物一样成环或盘绕和/或翻转以形成越来越小的嵌套囊。为了获得可翻转和填充动脉瘤的植入物,可将编织物制造成使得编织物在远侧端部被制作得更强,从而在被植入时倾向于朝预定形状移动并形成两个嵌套囊,并且在近侧端部处,编织物可制作得更弱,从而倾向于在囊内变平和折叠成条带形状。编织物可沿其长度具有可变的编织角,使得当被定位以用于递送时,编织物可在其远侧端部附近具有高编织角并且在近侧端部附近具有低编织角。除了可变编织角之外,或作为另一种选择,可对编织物进行热处理以使编织物在近侧端部处弱化。除此之外或作为填充最内层囊的编织物材料的替代物,该植入物可包括可在最内层囊内成环的栓塞性线圈。
用于治疗动脉瘤的示例性方法可包括以非特定顺序呈现的以下步骤中的一个或多个步骤。该示例性方法还可包括此处未列出的附加步骤。可选择具有第一端部、第二端部、从第一端部延伸的第一部分和从第二端部延伸的第二部分的基本上管状的编织物。可选择基本上管状的编织物,使得当编织物为沿从编织物的一端到编织物的另一端的长度具有均匀圆周的单层圆柱形形状时,与编织物的第一部分相比,编织物在编织物的第二部分中具有较小的编织角。编织物可被选择成使得当编织物为单层圆柱形形状时,其具有从第一部分延伸到第二部分的连续减小的编织角。
编织物可通过微导管被递送到动脉瘤。编织物可以单层管状形状递送,使得第一端部相对于第二端部定位在远侧方向上。
编织物的第一部分可膨胀到动脉瘤的壁。近侧翻转部可在动脉瘤的颈部处形成在编织物中。编织物的翻转的部分可膨胀以压到膨胀的第一部分中。远侧翻转部可在动脉瘤的壁的远侧部分处形成在编织物中,使得编织物的翻转的部分在远侧翻转部和近侧翻转部之间延伸。
可将编织物成形为在翻转的部分内形成在动脉瘤的壁的远侧部分附近的圆顶。除此之外或另选地,编织物可在远侧翻转部处扭曲,并且编织物可膨胀以在翻转的部分内形成囊。
编织物的第二部分可定位在翻转的部分内,以与翻转的部分直接接触、定位在形成于翻转的部分内的囊内或以其他方式定位在翻转的部分内。编织物的第二部分可被定位成使得第二部分在翻转的部分内变平并成环。
可选择栓塞性线圈。栓塞性线圈可被定位成使得其附连到编织物的第二端部。栓塞性线圈可通过微导管被递送到动脉瘤。栓塞性线圈可位于植入编织物的翻转的部分内。
示例性植入物可包括具有两个端部的管状编织物,该管状编织物能够成形为单层圆柱形形状,该单层圆柱形形状具有可从一端到另一端测量的长度,沿该长度的基本上均匀的圆周,在编织物的从两个端部中的第一端部延伸的第一部分上具有较大编织角,并且在编织物的从两个端部中的第二端部延伸的第二部分上具有较小编织角。在单层圆柱形形状中,编织物可具有从第一部分延伸到第二部分的连续减小的编织角。在单层管状形状中,编织物的尺寸可被设定成使其通过微导管被递送到动脉瘤。
编织物可从单层圆柱形形状移动成植入形状。在植入形状中,第一部分可被定位成与动脉瘤壁并置,翻转部囊可被定位成将第一部分压到动脉瘤壁,并且第二部分可被定位在翻转部囊内。在植入形状中,编织物的第二部分的至少一部分可在翻转的部分内成环。在植入形状中,第二部分可被定位成将翻转的部分压到第一部分。
在植入形状中,内囊可被定位成将翻转部囊压到第一部分,编织物可具有将内囊和翻转部囊分开的翻转部,并且编织物可在该翻转部处扭曲。
在植入形状中,编织物可在定位于动脉瘤的壁的远侧部分附近的翻转部囊内具有圆顶形状。
植入物还可包括附连到编织物的第二端部的栓塞性线圈。在植入形状中,编织物可被成形为允许栓塞性线圈定位在翻转部囊内,以与翻转部囊直接接触、通过编织材料与翻转部囊分开或者以其他方式定位在翻转部囊内。
另一种示例性植入物可包括具有第一端部和第二端部的管状编织物。该编织物可具有预定形状,该预定形状具有两个翻转部,它们将编织物分成三个节段:从第一端部延伸到两个翻转部中的第一翻转部的外部节段;在两个翻转部之间延伸并且至少部分地被外部节段围绕的中间节段;以及从两个翻转部中的第二翻转部延伸到第二端部且至少部分地被中间节段围绕的内部节段。在预定形状中,编织物可在内部节段上的位置处具有编织角的陡变,使得从第二翻转部延伸的内部节段的远侧部分具有比从第二端部延伸的内部节段的近侧部分更高的编织角。
编织物可移动形成尺寸被设定成使其定位在动脉瘤囊内的预定形状。在植入形状中,编织物的对应于在预定形状中的内部节段的部分可塌缩成条带形状并且定位在由编织物的对应于在预定形状中的中间节段的部分形成的翻转部囊中。
编织物可被成形为单层圆柱形形状,该单层圆柱形形状在编织物的两个端部之间具有基本上均匀的圆周,在编织物的从第一端部延伸的第一部分中具有较大的编织角,并且在编织物的从第二端部延伸的第二部分中具有较小的编织角。在单层圆柱形形状中,编织物可具有从第一部分到第二部分的连续减小的编织角。在单层圆柱形形状中,编织物的尺寸可被设定成使其通过微导管被递送到动脉瘤。
附图说明
将参考下面的描述并结合附图进一步讨论本发明的上述及其他方面,在这些附图中,类似的编号指示各种图中类似的结构元件和特征结构。附图未必按比例绘制,相反,将重点放在示出本发明的原理。附图仅以举例方式而非限制方式描绘了本发明装置的一种或多种具体实施。
图1是根据本发明的各方面的具有成形用于通过导管递送的编织物的植入物的图示;
图2是根据本发明的各方面的具有处于预定形状的编织物的植入物的图示;
图3A至图3I是根据本发明的各方面的动脉瘤治疗过程的步骤的图示;
图4示出了根据本发明的各方面的具有在远侧翻转部处扭曲的编织物的植入物;
图5A至图5B是根据本发明的各方面的动脉瘤治疗过程的步骤的图示;
图6是根据本发明的各方面的具有各自成形用于通过导管递送的编织物和栓塞性线圈的植入物的图示;
图7是根据本发明的各方面的具有编织物和栓塞性线圈并且编织物处于预定形状的植入物的图示;
图8是根据本发明的各方面的植入在动脉瘤中的具有编织物和栓塞性线圈的植入物的图示;并且
图9是列出可根据本发明的各方面执行的方法步骤的流程图。
具体实施方式
在宽颈动脉瘤的已知治疗中,通常通过将栓塞性线圈放置在动脉瘤囊内并且跨动脉瘤颈部将支架放置在亲代血管内来治疗动脉瘤。在许多情况下,支架是必要的,以抑制栓塞性线圈进入亲代血管。如果栓塞性线圈进入亲代血管,则线圈可阻塞血管并且/或者凝块可在血管内的线圈上形成并在亲代血管中产生栓塞。编织动脉瘤囊内植入物可用于治疗宽颈动脉瘤,而不需要支架将编织植入物固定在动脉瘤颈部处。然而,为了实现将编织植入物锚定在宽颈分叉中所必需的力,编织物可以是刚性的并且能够抵抗再成形为与预定形状显著不同的植入形状。因此,在一些情况下,可能具有挑战性的是以足够的编织密度填充动脉瘤以快速且有效地诱导动脉瘤囊内的血液停滞。被制造得太软的编织物的形状会变紧凑,并且当植入物不再密封动脉瘤的颈部时,导致动脉瘤再通。
本发明的各方面涉及解决上述挑战。在本文提供的示例中,管状编织植入物可包括如下编织物,该编织物可作为单层编织物递送,可在部署期间向内翻转以形成至少两个嵌套的囊,并且可包括可填充最内层囊的附加编织材料。该附加编织物材料可像带状物一样成环或盘绕和/或翻转以形成越来越小的嵌套囊。本发明的一个方面是提供如下结构,该结构允许将足够量的附加编织材料放置到最内层囊中,使得动脉瘤快速凝结以用于有效治疗。
当在本文中使用时,术语“管状”和“管”应广义地理解,并且不限于为正圆柱体的或横截面为完全圆周的或在其整个长度上具有均匀横截面的结构。为简单起见,本文通常将管状结构示出为具有基本上正圆柱形结构。然而,在不脱离本发明范围的情况下,管状结构可具有锥形或弯曲外表面。
为了满足对用于实现在动脉瘤内的牢固锚定的编织物刚度和用于使编织物在动脉瘤内变形为高填充密度的编织物柔软度的竞争需求,编织物可被制成使得当动脉瘤具有较高填充密度时编织物的被推入动脉瘤中的部分与编织物的膨胀以将编织物锚定在动脉瘤内的较硬部分相比较弱。编织物部分的刚度/柔性可通过编织角(例如,每英寸纬数)、股线直径、股线数量、股线材料和/或用于改变股线材料特性的处理(例如,热处理)等来控制。与较弱部分相比,较硬部分可具有较高的编织角、较大的股线直径、较多的股线、包含较硬材料的股线和/或被处理成具有较大刚度的股线。
当通过导管递送编织物时,编织物的较硬部分可定位在编织物的远侧端部附近,使得编织物的较硬部分在动脉瘤被填充之前离开导管并且膨胀以锚定在动脉瘤中。编织物的较硬部分可通过热定形或其他方式成形为预定形状,使得当较硬部分时,它们膨胀成预定形状。使编织物的较硬部分膨胀成预定形状的倾向可抵靠动脉瘤壁产生足够的力以将编织物锚定在动脉瘤囊中。当通过导管递送编织物时,编织物的较弱部分可定位在编织物的近侧端部附近。编织物的具有最大柔性的部分可动态地变形以在动脉瘤内成环或嵌套,从而在编织物的更硬的锚定部分内折叠。
除此之外或作为填充最内层囊的编织物材料的替代物,该植入物可包括可在最内层囊内成环的栓塞性线圈。
本文所述的示例通常包括编织植入物,该编织植入物可以固定在动脉瘤囊内并且堵塞大部分动脉瘤颈部。该植入物可包括具有较硬部分和较弱部分的管状编织物,至少该较硬部分被设定为预定形状,该编织物能够压缩以用于通过微导管递送,并且编织物能够植入到基于其中植入编织物的动脉瘤的几何形状并且至少部分地基于预定形状的植入位置中。
如图1所示,示例性植入物100可包括编织物110,该编织物可被成形为基本上管状的单层形状,该单层形状具有在每个端部112、114之间测量的长度L和沿长度L的可变刚度。如图所示,刚度可至少部分地由编织角θ1、θ2、θ3、θ4确定。为了便于讨论,编织物的较弱、较柔韧的部分被示出为与编织物的较强、较硬的部分相比具有较低的编织角;然而,编织物的较弱部分和较硬部分可在股线直径、股线数量、股线材料方面有所不同,其可被处理成具有不同的刚度/柔性,和/或通过本领域的普通技术人员将会知道和理解的其他方式产生不同。此外,包括具有不同刚度的编织物节段的示例性植入物可包括被接合以形成编织物的两个分开的区段,并且编织物不需要包括具有不同刚度的节段作为连续的编织管。
在图1所示的单层管状形状中,编织物110可具有沿长度L的基本上均匀的圆周C。该管状形状可具有沿编织物110的长度延伸的中心轴线A。如图所示并且如本领域的普通技术人员根据本文的教导内容原本将理解的,编织角θ1、θ2、θ3、θ4可通过将编织股线的切向轨线与中心轴线A进行比较来测量。
编织物可包括多根股线,例如约4至约96根股线,每根股线从一个编织物端部112延伸到另一个编织物端部114。如本文所用,针对任何数值或范围的术语“约”或“大约”指示允许部件或元件的集合实现如本文所述的其预期要达到的目的的合适的尺寸公差。更具体地,“约”或“大约”可指列举值的值±20%的范围,例如“约90%”可指71%至99%的值范围。股线可围绕圆周C螺旋缠绕。股线的数量、股线的角度、股线的直径、股线的材料和股线的材料特性均可为控制编织物110的材料特性(包括孔隙率和柔性)的因素。编织股线可被织造成使得约一半股线以顺时针螺旋缠绕,另一半以逆时针螺旋缠绕,并且相反缠绕的股线交替地彼此交叉和相互重叠。由于这样的构造,与编织物的具有较低编织角的部分相比,编织物的具有较高编织角的部分可具有较高的股线密度。较高的股线密度可产生较致密、较硬的编织物部分。
股线可由多种合金诸如镍钛合金、钴铬合金、铂、镍钛诺、不锈钢、钽或其他合金或者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。编织物110中的一些或全部可为复丝圆柱形网,该网优选由用于获得射线不透性的具有交织铂丝的镍钛诺或者具有约10%至40%铂的拉伸填充管(DFT)镍钛诺制成。编织物110的网中的开孔也可形成基本一体的框架或网。因此,开孔可具有可变的尺寸、形状或孔隙度,并且可在整个编织物110的网壁内均匀或随机地间隔开。开孔可提供具有柔性的编织物110,并且还有助于编织物从塌缩状态转变为膨胀的部署状态,反之亦然。
如图1所示的编织物110描绘了如从编织物110的近侧端部112到远侧端部114所测量的增加的四个编织角θ1、θ2、θ3、θ4,其中编织物110的近侧部分116中的编织角θ4最小,紧邻近侧部分116远侧的区段中的编织角θ3大于近侧部分116中的编织角θ4,下一个远侧区段中的编织角θ2大于紧邻其近侧的区段中的编织角θ3,并且编织物110的最远侧区段118中的编织角θ1最大。应当知道和理解,编织物110可包括具有不同编织角,从而具有不同刚度/柔性的两个或更多个区段。编织物可另外包括编织角的连续梯度变化,从而具有从一个编织物区段到另一个编织物区段的刚度/柔性的连续梯度变化,例如编织角可从近侧部分116到远侧部分118连续变化。
当编织物110的尺寸被设定成使其横贯导管时,植入物100可被递送到动脉瘤中。例如,编织物110可以如图1所示的单层管状形状递送,使得编织物的一端114是被定位成在编织物110的其余部分之前离开导管的远侧端部,并且另一端112是被定位成在编织物110的其余部分之后离开导管的近侧端部。另选地,编织物可以包括折叠部、翻转部和/或多层的其他形状递送。无论递送形状如何,编织物110都可具有被定位成在编织物110的其余部分之前离开导管的远侧部分118和被定位成在编织物110的其余部分之后离开导管的近侧部分116。远侧部分118可具有高编织角θ1,使得远侧部分118具有足够的刚度以将编织物110锚定在动脉瘤内。近侧部分116可具有低编织角θ4,使得近侧部分具有足够的柔性以塌缩到包含编织物110的其余部分的动脉瘤囊中。植入物100还可包括被配置成可拆卸地附接到植入物递送系统的脱离特征部150。脱离特征部150可在编织物110的近侧端部112处附连到编织物110。
图2示出了成形为预定形状的编织物110,诸如图1所示的编织物110。编织物110可包括记忆形状材料,诸如镍钛诺、镍钛诺合金、聚合物记忆形状材料或具有如本文所述的用于再成形的特性的其他记忆形状材料。编织物110可通过热定形或本领域普通技术人员知道和理解的其他方式设定为预定形状。编织段110可从预定形状塌缩成变形形状,该变形形状的尺寸被设定成使其横贯微导管到达动脉瘤。在离开微导管并与血液接触时,编织物110可从变形形状朝预定形状移动。动脉瘤和治疗部位的解剖结构可抑制编织物110移动成预定形状,使得当编织物110被部署时,其可呈现部分地基于预定形状和其中植入编织物的解剖结构的形状的部署形状。
在预定形状中,编织物110可包括两个翻转部122、124和将编织物110分成四个节段142、144、146、130的捏夹点126。在预定形状中,编织物110可具有从编织物110的开口端114延伸到两个翻转部122、124的第一翻转部122的外部节段142;在两个翻转部122和124之间延伸的中间节段144;从两个翻转部122、124的第二翻转部124延伸到编织物110的捏夹点126的内部节段146;以及从捏夹点126延伸到编织物110的相对端112的细长区段130。当处于预定形状时,管状编织物110可围绕中心竖直轴线y基本上径向对称。
图2示出了每个节段142、144、146、130的轮廓。脱离特征部150被示出为可与机械植入物递送系统(未示出)一起使用的扁平键。在例如美国专利申请公布号2019/0192162和2019/0328398中描述了示例性植入物递送系统,每个专利申请公布以引用方式全文并入本文。在植入物的递送和/或定位期间,键150可通过射线照相方法可视化。键150可从递送系统释放,从而将植入物100从递送系统释放。当释放植入物时,键可保持附接到植入物。
管状编织物110可以通过以下方式成形为预定形状:首先在捏夹点126处捏夹编织物110;然后将编织物向外翻转以利用翻转部124将内部节段146与中间节段144分离;然后,使中间节段144在形状结构件(form)上成形以产生所示的基本上“S”形的轮廓;并且最后将编织物110再次向外翻转以利用另一个翻转部122将中间节段144与外部节段142分离。任选地,编织物可在开口端114和/或近侧端部112处被修剪。开口端部114可以被定位成环绕中间节段144。开口端部114可以定位在编织物高度的中间第三节段内,如图所示。另选地,开口端114可定位在别处,例如在远侧翻转部124的附近。
外囊142可对应于如图1所示的编织物110的远侧部分118。当为图1所示的单层管状形状时,远侧部分118可沿其长度具有基本上均匀的编织角θ1。编织物110可在近侧拐折122处具有编织角的陡变。编织物110可具有穿过中间区段144和内部区段146的渐变的编织角变化。尾部130可具有沿尾部130的长度的基本上一致的编织角θ4。尾部130可对应于如图1所示的呈单层管状形状的编织物110的近侧部分116。
另选地,当编织物110呈单层管状形状时,在捏夹点126远侧的区段142、144、146可具有沿这些区段142、144、146的长度一致的高编织角θ1;尾部区段130可具有沿其长度一致的低编织角θ4,并且编织物110可在捏夹点126处具有编织角的陡变。尾部130可具有足够的柔性,使得当在血管内治疗部位处被操纵时,尾部130变平成条带形状并自身折叠。另选地,编织物110可在近侧拐折122处、在远侧拐折124处、在捏夹点126处或在它们的任何组合处包括编织角的陡变。
编织物110在开口端114处的股线可为自由的切割端;或者另选地,开口端114处的股线可为闭合的,这意味着开口端114处的编织物内的股线通过胶接、焊接等方式彼此附接,或者股线在开口端114处弯折。自由的切割端可具有更容易制造的优点,而闭合的股线端可具有比切割端更好地防止损伤的优点。
图3A至图3I示出了经由导管20植入动脉瘤10中的植入物100,诸如图1和/或2中所示的植入物100。导管20的尺寸可在考虑导管所必须穿过以到达治疗部位的动脉瘤或体腔的尺寸、形状和方向性的情况下加以选择。导管20可具有约80厘米至约170厘米的总可用长度。导管20可具有约0.015英寸至0.032英寸的内径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。导管20在其近侧端部26处可由最终使用者手动操作,并且在其远侧端部处可操作(如图所示)以定位在动脉瘤10的颈部16处。虽然导管20的远侧端部可包含植入物100,但远侧端部的形状可变化并且可以弯曲成角度。
图3A示出了编织物110的开口端114在动脉瘤10的囊12内膨胀以接触动脉瘤10的壁14。接触动脉瘤壁14的区段142'可对应于图2中所示的在预定形状中的外部区段142和/或图1中所示的编织物110的远侧较硬区段118。植入物100可被选择用于治疗,使得所选择的植入物100具有在预定形状中的外部节段142,该外部节段142的周长大于动脉瘤囊12的周长,这意味着编织物110的与动脉瘤壁14接触的区段142'在其趋于膨胀成预定形状时提供抵靠动脉瘤壁的力。因此,外部区段142'的植入形状的周长可小于外部区段142的预定形状。
图3B示出了翻转形成呈植入形状的近侧翻转部122'的编织物110。近侧翻转部122'可对应于在预定形状中的近侧翻转部122。
图3C示出了在外部区段142'内膨胀的编织物110。
图3D示出了在外部区段142'内部形成内囊144'的编织物。远侧翻转部124'被示出定位在动脉瘤壁14的远侧部分15的附近。远侧翻转部124'可对应于编织物110的在预定形状中的远侧翻转部124。内囊144'可对应于图2中所示的在预定形状中的中间节段144。内囊144'可对应于图1中所示的编织物110的刚性远侧部分118和/或编织物110的刚度小于远侧部分118的一部分。内囊144'可对应于编织物110的刚度大于图1所示的柔性近侧部分116的一部分。
图3E示出了进一步离开导管20并在内囊114'内膨胀的编织物110的可塌缩部分146'。可塌缩部分146'可对应于编织物110的在预定形状中的内部节段146。可塌缩部分146'可对应于图1中所示的编织物110的刚性远侧部分118和/或编织物110的刚度小于该远侧部分的一部分。可塌缩部分146'可对应于编织物110的刚度大于图1所示的柔性近侧部分116的一部分。
图3F示出了在远侧翻转部124'附近形成圆顶的可塌缩部分146'。在由可塌缩部分146'形成的圆顶的近侧上示出了捏夹点126'。在植入形状中的捏夹点126'可对应于在预定形状中的捏夹点126。
图3G示出了编织物110的近侧尾部130'变平成条带形状并且在由内囊144'和可塌缩部分146'的圆顶限定的空间内折叠。近侧尾部130'可对应于如图2所示的编织物的在预定形状中的近侧尾部130。近侧尾部130'可对应于图1中所示的柔性近侧部分116。
图3H示出了在由内囊144'和可塌缩部分146'的圆顶限定的空间内折叠的近侧尾部130'的附加长度。
图3I示出了呈最终植入形状的植入物100。外部区段142'、内囊144'和可塌缩部分146'以横截面示出,以更好地示出近侧尾部130'的折叠条带形状。
图4示出了编织物110的另选植入形状。如图4所示,编织物110可包括靠近远侧翻转部124'的扭曲125。在具有如图4所示的扭曲125或如图3I所示不具有扭曲的情况下,内囊144'可提供压到动脉瘤壁14和/或外部区段142'中的力F1,这取决于外部区段142'的覆盖范围。还示出了外部区段142'的另选构型,该构型使得开口端114定位为靠近动脉瘤壁14的远侧部分15。
图5A和图5B示出了图4中所示的植入物100的后续植入步骤。图5A示出了在前述第一内囊142'内膨胀的第二内囊132。图5B示出了提供压向第一内囊142'的第二力F2的第二内囊132。编织物110在图5B中以横截面示出。在后续植入步骤中,编织物110可形成附加的嵌套囊。除此之外或另选地,编织物可塌缩以形成条带形状并且折叠到由一个或多个嵌套囊限定的空间内,类似于如图3G至图3I所示。
图6示出了另选的植入物100a,其包括具有不同编织角θ1、θ4的两个区段116、118的编织物110;栓塞性线圈160和脱离键150。栓塞性线圈160可附接到编织物110的近侧端部112。编织物110的靠近近侧端部112的近侧部分116可具有小编织角θ4。编织物110的靠近编织物远侧端部114的远侧部分118可具有较大的编织角θ4。编织物110可被成形为如图6所示的单层管状形状。编织物可如本文别处所述被成形以用于递送。
图7示出了替代植入物100a,诸如图6所示的具有预定形状的编织物110的植入物100a。预定形状可类似于如关于图2所述具有四个区段142、144、146、130、两个翻转部122、124和捏夹点126。栓塞性线圈160可从编织物100的尾部区段130延伸。当被植入时,栓塞性线圈160可代替图3I所示的植入物100的尾部部分130'中的一些或全部。
图8示出了呈植入形状的植入物100a,诸如图6和/或图7中所示的植入物100a。编织物110在被植入时可具有类似于关于图3I和/或图4所公开的外部区段142'和内囊144'。栓塞性线圈160可在内囊144'内缠绕。
图9是概述用于使用植入物和/或系统治疗动脉瘤的示例性方法步骤的流程图,该植入物和/或系统是诸如本文所述的示例性植入物100、100a和/或系统、其变型或如本领域普通技术人员将了解和理解的另选的植入物和/或系统。
参见图9中概述的方法300,在步骤302中,可选择具有较强区段和较弱区段的管状编织物。所选择的管状编织物可包括本文所述的示例性管状编织物110、其变型或如本领域普通技术人员将了解和理解的其替代物。较强区段相对于较弱区段可具有较大的编织角,使得各编织物区段的强度分别至少部分地由相应的编织角确定。除此之外或另选地,可处理(例如,热处理)较强区段和较弱区段中的一者或两者以改变该一个或两个区段的材料特性,使得两个区段之间的强度差异至少部分地由处理来确定。除此之外或另选地,较强区段可具有比较弱区段数量更多的股线,使得各编织物区段的强度分别至少部分地由股线的数量确定。除此之外或另选地,与较弱区段中的股线的直径相比,较强区段中的股线可具有较大的直径,使得各编织物区段的强度分别至少部分地由股线的直径确定。除此之外或另选地,较强区段和较弱区段中的股线可包括不同的材料,使得各区段的强度分别至少部分地由股线的材料特性确定。
在步骤304中,可通过微导管将编织物递送到动脉瘤。编织物能够可拆卸地附接到细长的递送系统。植入物(以及由此编织物)可在递送系统的远侧端部处附接到递送系统。可将递送系统和植入物定位在微导管内,使得递送系统从微导管的近侧端部延伸。使用者(例如,医师)可通过操纵递送系统的从微导管的近侧端部延伸出来的部分来通过微导管递送植入物。使用者可类似于如图3A至图3I、图4、图5A至图5B和/或图8所示,如本文另外所描述,或者如本领域普通技术人员根据本文的教导内容所理解通过操纵递送系统从微导管的近侧端部延伸的部分来放置植入物。
在步骤306中,编织物的远侧端部可定位在动脉瘤壁14的远侧部分15处。编织物的远侧端部可被定位成如图4、图5A至图5B和/或图8所示。另选地,编织物的远侧端部可定位在别处,例如在动脉瘤壁14的中间三分之一内,如图3A至图3I所示在壁14的远侧部分15和动脉瘤颈部16之间的约一半位置处。
在步骤308中,编织物的较强区段可膨胀以形成与动脉瘤壁14的外囊并置。外囊的形状可类似于图4、图5A至图5B和/或图8所示的外囊142'。另选地,编织物的较强区段可膨胀以形成类似于图3A至图3I中所示的外部区段142'形状的碗状。
在步骤310中,近侧翻转部可在动脉瘤颈部处形成在编织物中。近侧翻转部的定位可类似于图3A至图3I、图4、图5A至图5B和/或图8所示的近侧翻转部122'。近侧翻转部的形状可类似于图3A至图3I、图4、图5A至图5B和/或图8所示的近侧翻转部122'。近侧翻转部122'可限定在步骤308中膨胀的外囊或外部区段与位于该外囊或外部区段内的翻转的部分之间的边界。
在步骤312中,翻转的部分可膨胀以形成位于外囊或外部区段内的囊。翻转的部分可压靠外囊(或外部区段),从而将外囊(或外部区段)压到动脉瘤壁14中。翻转的部分可形成诸如图3A至图3I、图4、图5A至图5B和/或图8中所示内囊144'。
在步骤314中,可在编织物中形成远侧翻转部。远侧翻转部可限定在步骤312中膨胀的翻转部内囊的远侧。远侧翻转部可限定内囊与编织物的内部非翻转的部分之间的边界。编织物的内部非翻转的部分可包括编织物的较弱区段。
在步骤316中,编织物的较弱区段可定位在翻转部囊中。该较弱区段可变平成条带形状并折叠成翻转部囊中。较弱区段可如图3G至图3I所示,如本文另外所描述,并且/或者如本领域普通技术人员根据本文的教导内容所理解的那样变平和折叠。较弱区段可对应于编织物110的尾部区段130、130'。
本文所包含的描述是本发明的实施方案的示例,并且不旨在以任何方式限制本发明的范围。本发明设想了植入物的许多变型形式和修改形式,包括:另选的递送方法、另选的编织材料、用于实现编织材料的期望刚度/柔性的另选方式、附连到植入物的附加结构(例如,有助于锚定植入物、血流转向、栓塞形成等的附加结构)、另选的预定编织物形状(例如,一个翻转部、三个翻转部、四个翻转部、五个或更多个翻转部、非径向对称形状、另选的节段形状等)、另选的植入形状等。对于接受本公开的教导内容的本领域普通技术人员显而易见的修改旨在落入所附权利要求书的范围内。
Claims (20)
1.一种方法,包括:
选择基本上管状的编织物,所述基本上管状的编织物包括:第一端部、第二端部、在所述第一端部和所述第二端部之间的长度、从所述第一端部延伸的第一部分和从所述第二端部延伸的第二部分,使得所述管状编织物能够成形为包括沿所述长度的基本上均匀的圆周的单层圆柱形形状、所述第一部分中的第一编织角和所述第二部分中的第二编织角,所述第二编织角的测量值小于所述第一编织角;
通过微导管将所述管状编织物递送到动脉瘤中;
使所述编织物的所述第一部分膨胀以与所述动脉瘤的壁并置;
在靠近所述动脉瘤的颈部处形成所述编织物的近侧翻转部;
使所述编织物的翻转的部分膨胀以将所述第一部分压到所述动脉瘤的壁;
在靠近所述动脉瘤的壁的远侧部分处形成所述编织物的远侧翻转部,使得翻转的部分从所述近侧翻转部延伸到所述远侧翻转部;以及
将所述编织物的所述第二部分定位在所述翻转的部分内。
2.根据权利要求1所述的方法,其特征在于,选择所述基本上管状的编织物还包括将所述管状编织物选择成使得所述单层圆柱形形状还包括从所述第一部分延伸到所述第二部分的连续减小的编织角。
3.根据权利要求1所述的方法,其特征在于,定位所述编织物的所述第二部分还包括使所述编织物的所述第二部分变平成条带形状并且使所述条带形状在所述翻转的部分内成环。
4.根据权利要求1所述的方法,其特征在于,还包括:
使所述编织物成形以在所述翻转的部分内形成圆顶,所述圆顶定位为靠近所述动脉瘤的壁的所述远侧部分。
5. 根据权利要求1所述的方法,其特征在于,还包括:
使所述编织物在靠近所述远侧翻转部处扭曲;以及
使所述编织物膨胀以在所述翻转的部分内形成囊。
6.根据权利要求1所述的方法,其特征在于,递送所述管状编织物还包括递送呈单层管状形状的所述管状编织物,使得所述第一端部相对于所述第二端部定位在远侧方向上。
7.根据权利要求1所述的方法,其特征在于,还包括:
选择栓塞性线圈;
将所述栓塞性线圈定位成使得其在靠近所述编织物的所述第二端部处附连到所述管状编织物;
通过所述微导管将所述栓塞性线圈递送到所述动脉瘤;以及
将所述栓塞性线圈定位在所述翻转的部分内。
8.一种植入物,包括:
基本上管状的编织物,其能够成形为单层圆柱形形状并且能够移动成植入形状,所述编织物包括:
第一端部;
第二端部;
可从所述第一端部到所述第二端部测量的长度;
从所述第一端部延伸的第一部分;
从所述第二端部延伸的第二部分;
在所述单层圆柱形形状中,沿所述长度的基本上均匀的圆周、在所述第一部分中的第一编织角和在所述第二部分中的第二编织角,所述第二编织角的测量值小于所述第一编织角;以及
在所述植入形状中,所述第一部分被定位成与动脉瘤壁并置,翻转部囊被定位成将所述第一部分压到所述动脉瘤壁,并且所述第二部分被定位在所述翻转部囊内。
9.根据权利要求8所述的植入物,其特征在于,
在所述单层圆柱形形状中,所述编织物包括从所述第一部分延伸到所述第二部分的连续减小的编织角。
10.根据权利要求8所述的植入物,其特征在于,
在所述植入形状中,所述编织物的所述第二部分的至少一部分在所述翻转的部分内成环。
11.根据权利要求8所述的植入物,其特征在于,
在所述植入形状中,所述第二部分被定位成将所述翻转的部分压到所述第一部分。
12.根据权利要求8所述的植入物,其特征在于,
在所述植入形状中,内囊被定位成将所述翻转部囊压到所述第一部分,所述编织物包括将所述内囊和所述翻转部囊分开的翻转部,并且所述编织物在靠近所述翻转部处扭曲。
13. 根据权利要求8所述的植入物,其特征在于,
当所述编织物呈所述单层管状形状时,所述编织物的尺寸被设定成使其通过微导管被递送到动脉瘤,并且
其中所述编织物能够从所述单层管状形状移动成所述植入形状。
14.根据权利要求8所述的植入物,其特征在于,还包括:
栓塞性线圈,所述栓塞性线圈在靠近所述编织物的所述第二端部处附连到所述管状编织物,
其中在所述植入形状中,所述编织物被成形为允许所述栓塞性线圈定位在所述翻转部囊内。
15.一种植入物,包括:
基本上管状的编织物,其包括第一端部、第二端部和预定形状,所述管状编织物能够移动成植入形状,所述植入形状的尺寸被设定成使其定位在动脉瘤囊中,
在所述预定形状中,所述管状编织物包括:第一翻转部、从所述第一端部延伸到所述第一翻转部的外部节段、第二翻转部、从所述第一翻转部延伸到所述第二翻转部的中间节段、以及从所述第二翻转部延伸到所述第二端部的内部节段,使得所述外部节段至少部分地围绕所述中间节段,并且所述中间节段至少部分地围绕所述内部节段,并且
在所述植入形状中,所述管状编织物的对应于在所述预定形状中的所述内部节段的至少一部分塌缩成条带形状并且定位在对应于在所述预定形状中的所述中间节段的翻转部囊中。
16. 根据权利要求15所述的植入物,其特征在于,
所述管状编织物能够成形为单层圆柱形形状,并且
其中在所述单层圆柱形形状中,所述编织物包括在所述第一端部和所述第二端部之间的基本上均匀的圆周、从所述第一端部延伸的所述编织物的第一部分中的第一编织角以及从所述第二端部延伸的所述编织物的第二部分中的第二编织角,所述第二编织角的测量值小于所述第一编织角。
17.根据权利要求16所述的植入物,其特征在于,在所述单层圆柱形形状中,所述编织物包括从所述第一部分延伸到所述第二部分的连续减小的编织角。
18.根据权利要求16所述的植入物,其特征在于,在所述单层管状形状中,所述编织物的尺寸被设定成使其通过微导管被递送到动脉瘤。
19.根据权利要求15所述的植入物,其特征在于,还包括:
栓塞性线圈,所述栓塞性线圈在靠近所述编织物的所述第二端部处附连到所述管状编织物。
20. 根据权利要求15所述的植入物,其特征在于,
在所述预定形状中,所述管状编织物包括在所述内部节段中的位置处的编织角的陡变,并且
其中从所述第二翻转部延伸的所述内部节段的远侧部分具有比从所述编织物的所述第二端部延伸的所述内部节段的近侧部分更大的编织角。
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-
2019
- 2019-12-05 US US16/703,973 patent/US11602350B2/en active Active
-
2020
- 2020-11-20 JP JP2020193178A patent/JP2021087772A/ja active Pending
- 2020-11-30 KR KR1020200164259A patent/KR20210070916A/ko unknown
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- 2020-12-04 EP EP20212016.8A patent/EP3831316A3/en not_active Withdrawn
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2022
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JP2021087772A (ja) | 2021-06-10 |
EP3831316A3 (en) | 2021-10-13 |
EP3831316A2 (en) | 2021-06-09 |
KR20210070916A (ko) | 2021-06-15 |
US20230062395A1 (en) | 2023-03-02 |
US11602350B2 (en) | 2023-03-14 |
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