CN114159120A - 可扩展开口导管 - Google Patents
可扩展开口导管 Download PDFInfo
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Abstract
本发明题为“可扩展开口导管”。本发明公开了一种导管系统,所述导管系统能够致动到展开状态并且包括导管主体和至少部分地定位在所述导管的管腔内的扩张器。所述扩张器的远侧端部能够可释放地连接到所述导管主体的远侧末端。所述扩张器能够是可回缩的以扩展并倒置所述远侧末端并且形成在所述展开状态下的漏斗形状。
Description
相关申请的交叉引用
本申请要求于2019年9月11日提交的美国临时申请62/898,864的权益,该临时申请的内容以引用方式并入本文。
技术领域
本公开整体涉及用于在血管内医学治疗期间从血管中移除急性堵塞物的装置和方法。更具体地讲,本公开涉及用于抽吸凝块的可扩展导管。
背景技术
在患者患有诸如急性缺血性中风(AIS)、心肌梗塞(MI)和肺栓塞(PE)等病症的情况下,在针对血管内干预的机械血栓切除术中经常使用凝块取回导管和装置。使用常规技术进入远处区域(诸如神经血管床)具有挑战性,因为目标脉管直径小、相对于插入部位较远并且高度迂回。
凝块本身可通过采取多种复杂的形态和稠度而使程序复杂化,范围从呈现血管形状的简单管状结构到可同时跨越多个脉管的长的链状排列。凝块的年龄也可影响其顺应性,其中较旧的凝块趋于比新鲜凝块更不可压缩。富含纤维蛋白的凝块还存在粘性性质的挑战,粘性性质可导致凝块沿机械血栓切除装置的外表面滚动而不是被有效地抓持。也可在抽吸期间分离软和硬凝块区域的组合,其中破裂会导致远侧栓塞,这可能发生在当前可用装置无法达到的脉管中。此外,破坏凝块粘附到脉管壁的粘结而不损坏脆弱的脉管是一个重大挑战。
常规的凝块取回导管,尤其是那些用于在神经血管中操作的凝块取回导管,可能具有许多缺点。首先,导管自身的直径必须足够小,以避免给患者造成显著的不适。导管还必须足够柔性以导通脉管系统并承受高应变,同时还具有轴向刚度以沿路线提供平滑推进。一旦到达目标部位,待从身体收回的典型对象的尺寸可基本上大于导管末端,使得将对象收回到末端中更加困难。例如,富含纤维蛋白的凝块通常难以抽取,因为它们可在传统固定开口导管的末端沉积。这种沉积可引起凝块的较软部分从较硬的区域切开,从而导致远侧栓塞。
小直径和固定的末端尺寸在引导手术期间移除血液和血栓物质所必需的抽吸方面也可能是较低效的。抽吸吸力必须足够强,使得通过使用机械血栓切除装置或其他方法发生的任何碎裂可最低程度上保持静止,使得碎片不能迁移和堵塞远侧脉管。然而,当用传统的固定开口导管抽吸时,抽吸流的相当大的部分最终来自导管末端附近的脉管流体,在该处没有凝块。这显著降低了抽吸效率,从而降低凝块去除的成功率。
本发明所公开的设计旨在提供一种解决上述缺陷的改进的抽吸取回导管。
发明内容
本设计的目的是提供满足上述需求的系统、装置和方法。该设计着重描绘了一种可扩展导管,该可扩展导管具有可扩展的面向凝块的开口以用于限制流量、提高抽吸效率并容易地取回凝块,同时还具有塌缩状态,该塌缩状态为低轮廓的并且足够柔性以用于在标准护套或外部导管中递送。该导管还可具有定制的可变刚度主体节段,该主体节段结合超过现有设计的可递送性增强并且能够行进穿过脉管系统的曲折区域以到达闭塞凝块。
在一些示例中,公开了能够致动到展开状态的导管系统。所述系统能够包括具有管腔的导管主体。扩张器能够至少部分地定位在所述管腔内,所述扩张器的远侧端部连接到所述导管主体的远侧末端。所述扩张器能够是可回缩的以扩展并倒置所述远侧末端,以形成在所述展开状态下的漏斗形状。
在一些示例中,所述远侧末端能够包括近侧段和从所述近侧段延伸并且基本柔性的远侧段。所述远侧段的近侧端部能够从所述近侧段延伸,并且能够包括邻近和/或连接到所述远侧段的远侧端部的拉环。
在一些示例中,在塌缩状态下的所述远侧段的中点转变为位于所述导管主体远侧的在所述展开状态下的所述漏斗形状的最远侧无创伤端部。
在一些示例中,在塌缩状态下的所述远侧段能够为基本管状的,并且在展开状态下能够包括所述漏斗形状。能够由所述漏斗形状在所述远侧端部和所述拉环之间形成气垫。
在一些示例中,所述远侧段可被分成近侧编织物部分和远侧螺旋部分。
在一些示例中,所述扩张器能够包括近侧段,并且位于所述近侧段远侧的远侧段能够具有大于所述近侧段的直径,远侧段能够包括接触元件,所述接触元件从所述扩张器的所述远侧段径向向外延伸并且被构造成接触并朝近侧平移所述拉环,直到在所述扩张器的所述远侧段的所述近侧端部处或附近对齐。
在一些示例中,所述接触元件能够包括与所述导管主体的所述远侧末端的所述远侧端部的过盈配合。
在一些示例中,所述扩张器的所述远侧段能够包括在接触元件处具有最大直径,并且从所述接触元件到所述远侧段的所述远侧端部逐渐减小。
在一些示例中,所述扩张器的所述远侧段在所述接触元件处具有最大直径,并且从所述接触元件到所述扩张器的所述近侧段和所述远侧段之间的接合部渐缩。
在一些示例中,所述扩张器的所述近侧段为高度柔性的或比所述扩张器的所述远侧段明显更柔性的。
在一些示例中,所述扩张器能够包括在所述较刚性的远侧段的远侧延伸的基本柔性的段,所述基本柔性的段为短鼻部。
在一些示例中,所述扩张器的所述近侧段能够包括纤维增强系统以阻止伸长。
在一些示例中,所述扩张器能够包括近侧段和位于所述近侧段远侧的远侧段。所述扩张器的所述远侧段能够具有大于所述近侧段的最大直径。所述扩张器的所述远侧段能够包括远侧接触元件,所述远侧接触元件从所述远侧段径向向外延伸并且被构造成接触并朝近侧平移所述拉环,直到在所述远侧段的所述近侧端部处或附近对齐。所述扩张器的近侧接触元件能够与所述远侧接触元件朝近侧间隔开并且从所述远侧段径向向外延伸,并且被构造成接触并朝近侧平移所述拉环,近侧接触元件能够具有小于所述远侧接触元件的直径。所述拉环能够连接在所述接触元件之间。
在一些示例中,所述拉环能够定位在位于所述接触元件之间的间隙中。
在一些示例中,当处于所述展开状态的所述漏斗形状时,所述接触元件能够包括与所述远侧末端的所述远侧端部的过盈配合。
在一些示例中,所述接触元件中的至少一者包括磁性连接器,所述磁性连接器能够操作以将所述远侧末端磁性回缩到所述展开状态的所述漏斗形状。
在一些示例中,所述扩张器的所述近侧段和/或所述远侧段能够包括基本上变薄的壁。
在一些示例中,所述近侧段能够包括被构造成防止在张力下伸长的绳状细丝。
在一些示例中,所述远侧末端的所述近侧段能够比所述远侧段更刚性。
在一些示例中,所述远侧段能够比近侧段更刚性。
在一些示例中,所述远侧段能够包括在展开之前用于保持基本管状形状的阻力。
在一些示例中,所述远侧末端的所述近侧段和/或所述远侧段能够包括编织结构。
在一些示例中,所述远侧末端的所述近侧段和/或所述远侧段能够包括记忆合金。
在一些示例中,在塌缩状态下的所述远侧末端的所述远侧段能够为基本管状的并且在所述展开状态下能够包括所述漏斗形状,由所述漏斗形状在所述远侧端部和所述拉环之间形成气垫。
在一些示例中,所述扩张器能够包括近侧段和位于所述近侧段远侧的远侧段。所述远侧段能够包括远侧接触元件,所述远侧接触元件从所述远侧段径向向外延伸并且被构造成接触并朝近侧平移所述拉环,直到在所述远侧末端的所述远侧段的所述近侧端部处或附近对齐。所述拉环能够包括磁性连接器。所述远侧末端的所述近侧端部被磁化构造成吸引所述拉环,从而使得所述远侧末端头回缩至所述漏斗形状。
在一些示例中,所述远侧末端的所述近侧端部和所述拉环在展开状态下锁定在一起,包括但不限于对应磁体锁定在一起。
在一些示例中,所述远侧末端的所述近侧端部和所述拉环各自包括平面配对表面。
在一些示例中,所述远侧末端的所述近侧端部和所述拉环各自包括具有异形的脊和/或互锁凹陷部的配对表面。
在一些示例中,所述远侧末端的所述近侧端部和所述拉环各自包括渐缩以用于渐缩锁定相互作用的配对表面。
在一些示例中,所述远侧末端的所述近侧端部和所述拉环各自包括被构造成卡扣锁定在一起的配对表面。
在一些示例中,所述拉环具有与所述导管主体类似的直径,使得在展开状态下在所述拉环和所述导管主体之间形成邻接部。所述远侧末端能够从所述拉环的内径朝远侧并且围绕所述拉环的外径延伸,以在所述导管主体上方朝近侧延伸。
在一些示例中,所述远侧末端能够包括近侧段和从所述近侧段延伸的远侧段。所述远侧末端的所述远侧段能够是基本柔性的,并且包括定位在所述远侧末端的外表面上的近侧端部。所述远侧末端的所述远侧段能够包括邻近或刚好位于所述远侧段的远侧的拉环。所述远侧末端能够被构造用于在所述拉环和所述导管主体的远侧面之间相互作用。
在一些示例中,所述远侧末端的所述远侧段的所述近侧端部能够在所述拉环外部。
在一些示例中,所述远侧末端能够与所述导管主体成一整体。所述远侧末端能够包括近侧段和从所述近侧段延伸的远侧段。所述远侧段能够是基本柔性的并且包括近侧端部,在被构造成漏斗形状时所述近侧端部与其内部的拉环基本对齐。
在一些示例中,所述扩张器能够包括基本上管状的近侧段和位于所述近侧段远侧的远侧段。所述扩张器的所述远侧段能够具有大于所述近侧段的直径。所述扩张器的所述远侧段能够包括接触元件,所述接触元件从所述远侧段径向向外延伸并且被构造成接触并朝近侧平移所述拉环,直到在所述远侧末端的所述近侧段的远侧端部处或附近对齐。
在一些示例中,所述接触元件能够是向外成角度的闩锁。
在一些示例中,所述接触元件能够是正交向外的闩锁。
在一些示例中,所述接触元件能够位于所述远侧段的所述近侧端部的远侧。
在一些示例中,在塌缩状态下的所述远侧末端的所述远侧段的中点转变为位于所述导管远侧的在所述展开状态下的所述漏斗形状的最远侧花瓣末端。
在一些示例中,在塌缩状态下的所述远侧末端的所述远侧段的中点转变为位于所述导管远侧的在所述展开状态下的所述漏斗形状的最远侧花状花瓣末端。
在一些示例中,所述扩张器能够包括近侧段和位于所述近侧段远侧的远侧段。所述远侧段能够包括远侧接触元件,所述远侧接触元件从所述远侧段径向向外延伸并且被构造成接触并朝近侧平移所述拉环,直到在所述远侧末端的所述近侧端部处或附近对齐。
在一些示例中,所述扩张器能够包括从所述远侧接触元件朝近侧渐缩的近侧接触元件。所述近侧接触元件能够具有小于所述远侧接触元件的直径。在一些示例中,所述远侧接触元件能够是向外延伸的环状构件。在一些示例中,所述远侧接触元件能够包括半圆形状。在一些示例中,所述远侧接触元件能够连接到所述拉环。
在一些示例中,在塌缩状态下的远侧段的中点转变为位于所述导管远侧的在所述展开状态下的所述漏斗形状的最远侧花瓣末端。
在一些示例中,在塌缩状态下的所述远侧段的中点转变为位于所述导管远侧的在所述展开状态下的所述漏斗形状的最远侧花状花瓣末端。
在一些示例中,所述扩张器能够包括近侧段和位于所述近侧段远侧的远侧段。所述远侧段能够具有大于所述近侧段的最大直径,并且能够具有大于所述近侧段的直径。远侧接触元件能够包括从所述远侧段到所述近侧段的转变并且被构造成接触并朝近侧平移所述拉环,以引起与所述拉环的过盈配合,从而传递力以使所述远侧末端伸展成所述漏斗形状。
在一些示例中,所述远侧末端被构造成在倒置以形成所述漏斗形状之前首先扩展成基本圆锥形状。
在一些示例中,所述扩张器的所述近侧段是高度柔性的并且包括薄壁。
在一些示例中,所述扩张器的所述近侧段是高度柔性的并且包括纵向绳状纤维以防止所述近侧段在张力下拉伸。
在一些示例中,在形成所述倒置漏斗形状时,所述扩张器和所述拉环之间的过盈力不能使所述拉环朝近侧移动。
在一些示例中,所述扩张器末端可挤压穿过拉环。
在一些示例中,所述扩张器末端容易地回缩通过所述导管。
在一些示例中,所述扩张器末端能够包括近侧段和从所述近侧段延伸的远侧段。所述远侧段能够是基本柔性的,并且至少部分地定位在所述近侧段周围,所述近侧段至少位于所述远侧段的近侧端部处。所述远侧末端能够包括拉环,所述拉环能够包括与所述近侧段的内渐缩部匹配的外渐缩部,使得在形成所述漏斗形状时所述渐缩部锁定在一起。
在一些示例中,所述编织物在所述远侧末端的中点处周向延伸以有助于限定圆化的倒置接缝。
在一些示例中,所述编织物从所述远侧末端的近侧端部延伸到远侧端部,从而提供圆化的倒置接缝。
在一些示例中,所述编织物包括从近侧部分延伸到中间部分的细丝子集,使得所述细丝倒置以延伸回到所述近侧部分,从而形成环状编织物式样,并且剩余的细丝从近侧端部延伸到远侧端部,使得螺旋部分形成在成环的细丝子集的远侧。
在一些示例中,所述编织物包括以螺旋构型从近侧部分延伸到远侧部分的细丝。
在一些示例中,所述编织物包括在所述中间部分中或围绕所述中间部分的倒置铰链。
在一些示例中,所述近侧部分能够是相对刚性的。所述中间部分能够是相对柔性的,并且所述远侧部分能够包括柔性螺旋。
在一些示例中,所述远侧末端能够包括具有近侧部分、中间部分和远侧部分的编织物,其中所述远侧部分具有足够的径向力以径向向外推动所述近侧部分,同时被构造成能够以无创伤方式适应各种血管尺寸。
在一些示例中,公开了一种在血管中倒置可扩张导管的方法。所述方法能够包括将所述导管推进到目标部位;以及通过至少部分地位于所述导管的管腔内的扩张器回缩所述导管的远侧末端,使得所述远侧末端扩展并倒置成漏斗形状。
在一些示例中,所述方法能够包括通过所述漏斗形状限制血管中的流量。
在一些示例中,所述方法能够包括从所述导管撤出所述扩张器;通过所述导管抽吸以刺激血栓进入所述漏斗形状的开口中;以及从患者中撤出带有所捕获的血栓的所述导管。
在一些示例中,所述方法能够包括用机械血栓切除装置捕获闭塞血栓;以及将所述血栓切除装置撤出到所述导管的所述漏斗形状中。
在一些示例中,能够不需要所述扩张器。在此类方法中,塌缩的末端能够塞到凝块上,并且抽吸吸力能够朝近侧拉动所述远侧端部以使所述末端倒置并在抽吸期间形成所述倒置漏斗形状。
在结合附图查看以下具体描述之后,本公开的其它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
将通过附图的如下描述进一步讨论本公开的上述及其它方面,在这些附图中,相同的编号指示各个图中相同的结构元件和特征。附图未必按比例绘制,而是将重点放在示出本公开的原理。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。期望本领域的技术人员能够构思并组合来自多个附图的元件,以更好地满足使用者的需求。
图1A描绘了可扩张导管的处于具有本公开的扩张器的第一构型的可扩张末端。
图1B描绘了可扩张导管的处于具有图1A的扩张器的另一构型的可扩张末端。
图1C描绘了可扩张导管的处于具有图1A的扩张器的另一构型的可扩张末端。
图2A描绘了根据本公开的方面展开到目标位置的图1A至图1C的可扩张导管的可扩张末端。
图2B描绘了根据本公开的方面展开到目标位置的图1A至图1C的可扩张导管的可扩张末端。
图2C描绘了根据本公开的方面展开到目标位置的图1A至图1C的可扩张导管的可扩张末端。
图2D描绘了根据本公开的方面展开到目标位置的图1A至图1C的可扩张导管的可扩张末端。
图3A描绘了可扩张导管的处于具有本公开的扩张器的第一构型的可扩张末端。
图3B描绘了可扩张导管的处于具有图3A的扩张器的另一构型的可扩张末端。
图4A描绘了可扩张导管的处于具有本公开的扩张器的第一构型的可扩张末端。
图4B描绘了可扩张导管的处于具有图4A的扩张器的另一构型的可扩张末端。
图5A描绘了可扩张导管的处于具有本公开的扩张器的展开构型的可扩张末端。
图5B描绘了可扩张导管的处于具有本公开的扩张器的展开构型的可扩张末端。
图5C描绘了可扩张导管的处于具有本公开的扩张器的展开构型的可扩张末端。
图6A描绘了可扩张导管的处于具有本公开的扩张器的展开构型的可扩张末端。
图6B描绘了可扩张导管的处于具有本公开的扩张器的展开构型的可扩张末端。
图6C描绘了可扩张导管的处于具有本公开的扩张器的展开构型的可扩张末端。
图7A描绘了根据本公开的方面展开的图6B的可扩张导管的可扩张末端。
图7B描绘了根据本公开的方面展开的图6B的可扩张导管的可扩张末端。
图7C描绘了根据本公开的方面展开的图6B的可扩张导管的可扩张末端。
图8A描绘了根据本公开的方面展开的可扩张导管的可扩张末端。
图8B描绘了根据本公开的方面展开的图8A的可扩张导管的可扩张末端。
图8C描绘了根据本公开的方面展开的图8A至图8B的可扩张导管的可扩张末端。
图9A描绘了可扩张导管的处于具有本公开的扩张器的展开构型的可扩张末端。
图9B描绘了处于图9A的展开构型的可扩张末端,其中扩张器被移除。
图10A描绘了根据本公开的方面的处于第一构型的可扩张导管的可扩张末端。
图10B是根据本公开的方面的处于展开构型的图10A的可扩张末端的特写。
图11A描绘了可扩张导管的处于具有本公开的扩张器的第一构型的可扩张末端。
图11B描绘了可扩张导管的处于具有图11A的扩张器的另一构型的可扩张末端。
图12A描绘了根据本公开的处于一种构型的可扩张导管的可扩张末端的侧视图。
图12B描绘了根据本公开的处于另一构型的图12A的可扩张末端的后视图。
图12C描绘了根据本公开的图12B的可扩张末端的侧视图。
图12D描绘了根据本公开的图12B的可扩张末端的前视图。
图13描绘了根据本公开的处于一种构型的可扩张导管的可扩张末端的侧视图。
图14A描绘了根据本公开的处于一种构型的可扩张导管的可扩张末端的侧视图。
图14B描绘了根据本公开的处于另一构型的图14A的可扩张末端的后视图。
图14C描绘了根据本公开的图14B的可扩张末端的侧视图。
图14D描绘了根据本公开的图14B的可扩张末端的前视图。
图15A描绘了根据本公开的处于一种构型的可扩张导管的可扩张末端的侧视图。
图15B描绘了根据本公开的图15A的可扩张末端的近距离视图。
图15C描绘了根据本公开的图15A的可扩张末端的近距离视图。
图16A描绘了根据本公开的图15A的可扩张末端的近距离视图。
图16B描绘了根据本公开的图15A的可扩张末端的近距离视图。
图16C描绘了根据本公开的图15A的可扩张末端的近距离视图。
图16D描绘了根据本公开的图15A的可扩张末端的近距离视图。
图16E描绘了根据本公开的图15A的可扩张末端的近距离视图。
图16F描绘了根据本公开的图15A的可扩张末端的近距离视图。
图17是概述根据本公开的方面的系统的使用方法的流程图。
具体实施方式
本公开的解决方案的目标是一种可倒置可扩张导管,该导管具有大的面向远侧的开口和能够行进穿过脉管系统的曲折区域以到达闭塞凝块的定制的高度柔性主体节段,能够提供的局部流量限制/阻止两者。流量限制和大末端设计提供显著更大的抽吸效率。此类优点在脑卒中干预手术情况下也是特别有益的,其中神经血管床中的脉管特别小且迂回,并且因此定制的轴向且抗弯刚度轮廓可抑制扭结和粘合。该导管还可与相对低轮廓的进入护套和外部导管兼容,使得患者腹股沟中的穿刺伤口(在股骨进入的情况下)可容易和可靠地闭合。导管还可具有内部和/或外部低摩擦衬里特征,以及围绕支撑结构设置的外部聚合物护套或膜。
这些改进可导致导管和其他装置安全并且更快速地进入复杂区域,以便移除阻塞物并缩短手术时间。虽然本说明书在许多情况下是在机械血栓切除术治疗的背景下,但这些系统和方法也可适用于其他手术和其他身体通道。
进入血管系统内的各种脉管(无论是冠状动脉、肺血管还是脑血管)涉及众所周知的手术步骤和许多常规的可商购获得的辅助产品的使用。这些产品诸如血管造影材料、旋转止血阀和导丝广泛用于实验室和医学手术中。当这些产品与以下描述中的本公开的系统和方法结合使用时,其功能和确切构造未被详细描述。
参见附图,在图1A至图1C中,示出了用于从患者的血管BV移除闭塞凝块C(如图2A至图2D所示)的导管系统100。系统100可以是具有传统构造的抽吸导管,或者可具有快速交换(RX)型特征,其中许多特征可大大提高凝块取回程序的速度和效率。具体地讲,图2A至图2D示出了根据本公开的方面的扩展到目标血管BV的导管100的导管主体50。系统100可被致动到图1C所示的展开状态。扩张器70可至少部分地定位在导管主体50的管腔47内。扩张器70的远侧端部78可连接到导管主体50的远侧末端51。扩张器70可以是可回缩的以倒置远侧末端51并形成在展开状态下的漏斗形状,如系统从图1A的初始伸长状态朝近侧移动一段或多段距离D至图1C中的展开状态所示。虽然图1C确实示出了展开状态,但扩张器70将在抽吸之前完全移除,以便使可能通过导管主体的末端51的流量最大化,并且还以便允许微导管和支架取栓器通过。扩张器70还可包括朝远侧突出的微导管部分,使得在漏斗的激活和扩张器70的移除期间支架取栓器可跨凝块暴露。
对于M1中的大约2mm导管主体的OD,塌缩OD与展开漏斗OD的比率预期在大约2.5mm至4.0mm之间的范围。在颈动脉T处,该比率预期在4.0mm至6.0mm的范围。在比率预期在5.0mm至8.0mm的范围的情况下,该比率对于ICA血管放置是可行的。在比率预期在2.5mm至5.0mm的范围的情况下,设想该比率针对目标M1和颈动脉T位置。
在一些示例中,塌缩OD与漏斗OD之间的比率取决于塌缩时对应导管末端的长度。优选地,对于大约2.5mm至5.0mm的扩展OD,末端塌缩长度可在3mm至8mm之间的范围(例如,图中的距离D)。然而,在一些示例中,该比率可以是设置的编织物的直径和编织角的函数。
系统100可被构造成扩展到宽泛的目标血管直径范围,诸如颈动脉末端(3.2mm至5.2mm)、大脑中动脉的水平段M1(1.6mm至3.5mm)和/或内颈动脉(ICA,2.7mm至7.5mm)。如果导管系统100随后从M1段回缩到ICA(或具有朝近侧增加的血管内径的另一条路径),则一旦末端50处于漏斗形状,其径向力就可在各种血管尺寸范围内继续与血管密封。此外,能够适应各种目标血管直径的末端50还可在血管分叉处密封,这些血管分叉可具有比分叉近侧的血管和分叉远侧的血管更宽的横截面积。优选地,末端51在治疗位置处倒置成展开的漏斗形状,以避免必须将漏斗形导管末端推进穿过脉管系统。
导管系统100的理想标称直径取决于目标凝块的位置和/或导管系统100将通过其递送的任何其他导管的直径。为了取回大脑血管床的颅内血管中的凝块,其中M1位置处的血管直径通常为约3mm,适用的系统可具有内径为0.065”至0.080”的外部导管和内径为0.055”至0.070”的RX凝块取回导管。在展开时,末端50的最大直径可以是最少2.5mm(但在一些情况下高达8mm),从而允许其抵靠血管的壁密封并提供与血管本身一样大的漏斗形远侧开口。在一些情况下,末端51还可提供足够大的开口以与分叉和/或近侧血管位置相对。与常规导管相比,该密封与所公开的RX系统的最大近侧管腔结合,在凝块面处的抽吸力和利用外部导管的较大内径的设计增加流量方面提供了益处。
在一些示例中,远侧末端51可包括近侧段55和从近侧段55延伸的远侧段52。段52可以是基本柔性的,并且远侧段52的近侧端部53可从近侧段55延伸并且包括邻近和/或连接到远侧段52的远侧端部58的拉环54。在该示例中,拉环54可定位在远侧段52内的远侧端部的近侧面54上。就这一点而言,段52可以是附接在拉环54下方的可扩展护套。
当扩张器70在连接到远侧端部58的同时朝近侧移动距离D时,处于如图1A的塌缩状态的远侧段52的中点可转变为位于导管主体50的远侧的在如图1C的展开状态下的漏斗形状的最远侧无创伤端部。塌缩状态下的远侧段52可以是基本管状(图1A),而在朝近侧移动距离D(图1B、图1C)之后的展开状态下,段52可包括漏斗形状。
在一些示例中,由倒置的远侧段52形成的漏斗形状可包括在远侧端部58和拉环54之间形成的气垫60。在该漏斗形状的一些示例中,环54可定位在管腔47内部以与其形成压缩锁,从而将段52固定在其扩展的漏斗形状。该压缩锁可通过将环54装配在管腔47内而被定义为过盈配合,该管腔的内径可略小于环54的外径。
在一些示例中,远侧段52可被分成近侧编织物部分和远侧螺旋编织物部分。弹性膜可交织、涂覆在编织物或倒置框架结构上或在其上方延伸。例如,弹性膜可沿循末端51的底层编织撑条框架的轮廓。该弹性膜可至少部分地覆盖末端51的长度。在其他示例中,末端51还可涂覆有润滑材料,诸如可商购获得的亲水涂层(例如,Surmodics、Harland、Biocoat、Covalon),或者可包括低摩擦材料或填料。膜还可浮置在倒置支撑结构上方,使得该倒置结构撑条可在该膜下方自由移动。在一些示例中,膜包封倒置支撑结构。
在一些示例中,扩张器70可包括近侧段76和从其朝远侧延伸的远侧段77。段77可具有大于近侧段76的直径并且包括接触元件71,该接触元件径向向外延伸以接触拉环54并将该拉环朝近侧平移一段或多段距离D,直到在远侧段52的近侧端部53处或附近对齐。在该示例中,接触元件71可以是突然的成角度向外转变,这创造了与段52的远侧端部58形成过盈配合的接触表面。
在一些示例中,扩张器70可以是实心和/或中空的(其中具有管腔)。扩张器70可包括内腔75,该内腔在该扩张器近侧段76处是基本细长的(例如,管状的),然后径向向外渐缩至具有远侧端部78的远侧段77,该远侧端部具有比近侧段76更大的直径。该渐缩可在段76、77之间的转变处或接合部73处开始。扩张器70在末端51近侧可以是高度柔性的。扩张器70可包括一种或多种纤维作为其结构的一部分,所述一种或多种纤维被构造用于增强以阻止该扩张器伸长。在一些示例中,段76可以是高度柔性的或基本上比远侧段77更柔性的。远侧段77在一些示例中仍可具有足够的柔韧性以围绕曲折的脉管系统扭曲。将力传递到环54所需的任何刚性部分可保持尽可能短以保持末端51的侧向柔韧性。
在一个示例中,系统100可使用抽吸源来捕获凝块,如图2A至图2D所示。具体地讲,图2A至图2D示出了系统100正在展开然后抽吸凝块C,优选地如图2D中那样完全移除扩张器70。使用如图所示和所述的扩张器70的主要优点在于,其可在末端倒置之后被移除,使得可使用导管50的整个横截面积以使当处于漏斗形状时穿过导管主体50的流量和凝块C上的力最大化,如图所示。还如图2A至图2D所示,由末端51扩展形成的漏斗形状可与血管BV的壁密封,或者可选择性地激活一个或多个密封处(例如,通过朝近侧或朝远侧移动扩张器70)。
一旦扩展,末端51可包括用于有效抽吸的大的无创伤开口。末端51可包括防扭结特性以有助于将其推进到目标位置。因此,如本文所述,其可具有多种构型或由多种材料制成,以便保持横向柔韧性但避免在压缩中扩展或扭结。图2A至图2D所示的末端51的大远侧开口可提供优于常规固定开口设计的改善的性能,该常规固定开口可通过使坚固、富含纤维蛋白的凝块滞留在末端中和/或通过使凝块的较软部分被剪切掉而受阻。凝块不太可能滞留在所公开的可倒置可扩张末端51的管状部分中,这是由于在凝块进入还原漏斗形状时对该凝块的逐渐压缩。
末端51的撑条可由镍钛诺或具有足够弹性应变量的另一种形状记忆材料形成,使得当该末端被约束并以塌缩构型在外部导管内递送时或在扩展以倒置成漏斗形状期间不会超过弹性极限。这些撑条可仅被热定形扩展以促进在预定位置处的倒置,所述扩展区域受到外膜覆盖物的限制。就这一点而言,主动倒置框架随后通过增加该框架的径向力向外推动膜。在另一种情况下,框架可由线构造,从而允许采用非超弹性材料如不锈钢合金,因为线将彼此独立地自由移动。应当理解,还可设想由使用超弹性或形状记忆材料的线构造的末端51的框架,这种装置提供改善的扭矩和耐久性特性。在另一种情况下,末端51的框架可被激光切割或可由来自非超弹性或形状记忆材料的线形成,该非超弹性或形状记忆材料通过包括单元或弯曲部来适应应变,其中需要较低程度的应变来从用于递送的塌缩状态移动到用于凝块取回的扩展状态。例如,框架可包括附加的单元、较长的单元撑条和/或较低的单元角度以降低应变要求。
图3A至图3B描绘了另一个可倒置可扩张末端251,该可倒置可扩张末端从图3A所示的具有扩张器270的第一构型开始,然后到图3B中的没有扩张器270的末端251的漏斗形状展开构型的特写。虽然未示出扩张器270,但可根据需要或要求将其包括在图3B中。应当理解,贯穿本公开讨论的类似参考标号示例指示相同或功能类似的元件。由此,扩张器270可包括内腔275,该内腔具有近侧段276和终止于近侧段276远侧的远侧端部278中的远侧段277。扩张器270可包括从远侧段277径向向外延伸的远侧接触元件271。元件271可被构造成接触并平移拉环254,直到在远侧段252的近侧端部258处或附近对齐。扩张器270还可包括突然的成角度向外转变(例如,此处的元件271基本上正交于扩张器270的外表面),以形成与段252的远侧端部258形成过盈配合的接触表面。扩张器270还可具有近侧接触元件273,该近侧接触元件与远侧接触元件271朝近侧间隔开并且类似地从远侧段277径向向外延伸。在一些示例中,凹槽可被限定在元件271、273之间,在其中拉环254可被定位或以其他方式连接。就这一点而言,元件271、213之间的空间或凹槽的相对面可以是平面的或以其他方式适形于环254的形状。在一些示例中,元件271可推动到或以其他方式联接到端部258,而元件273可推动到或以其他方式联接到环254。在一些示例中,元件273可具有小于元件271的直径,或反之亦然。从元件271到远侧端部278,扩张器270可渐缩至较小直径。
如在系统100中,当处于展开状态的漏斗形状时,可在远侧末端251的远侧端部258之间在导管主体250中提供过盈配合。在一些示例中,接触元件271、273中的至少一者可包括磁性连接器,该磁性连接器可操作以将远侧末端251磁性回缩到展开状态的漏斗形状。这样,其中的磁性联接可有利于将末端271致动到展开状态的倒置漏斗形状。段276和/或段277可包括基本上变薄的壁。优选地,从段276到段277,扩张器可包括在末端近侧的相对薄的壁,以获得最佳柔韧性。
在一些示例中,段276可包括被构造成防止在张力下伸长的绳状细丝。相对于末端251,其近侧段255可比远侧段252更刚性。然而,该示例不限于此。相反,段252可比近侧段255更刚性。在一些示例中,段252可包括在展开之前用于保持其基本管状形状的阻力或偏压,如图3A。类似于段152、155,近侧段255和/或远侧段252还可包括编织结构。例如,段252、255可由包括记忆合金的撑条的框架构造而成。类似于段52,段252可被分成近侧编织物部分和远侧螺旋编织物部分,并且还包括一个或多个弹性体涂层或膜。该示例的编织物部分和螺旋部分可例如通过在逆时针编织线的端部之间的中点处结束顺时针编织线的端部来形成,使得逆时针编织线形成超过该点的螺旋。在一些示例中,这可通过在圆周平面上在标准编织物的端部之间的某一位置处切割该编织物的顺时针线来实现。在另一个示例中,顺时针编织物可成环以朝近侧延伸,使得更致密的近侧编织物与远侧螺旋部分配对。
图4A至图4B描绘了导管350的另一个可倒置可扩张末端351,该可倒置可扩张末端从图4A所示的具有扩张器370的第一构型开始,然后到在扩张器370已回缩以使末端351倒置成漏斗形状后的图4B中的漏斗形状展开构型的特写。在这种情况下,末端351的近侧段355可包括远侧端部353,该远侧端部可包括能够与对应的环354联接的磁性元件,该对应的环继而可被磁化。如图所示的环354可被构造成与端部353磁性联接,这样末端351便可保持图4B所示的倒置漏斗形状。在一些示例中,环354和/或端部353可由含铁金属制成,使得一者被吸引到另一者。另选地,两个特征部均为磁性的,使得一个特征部的南磁极与另一个特征部的北磁极接合以形成比使用含铁金属时更强的接合。在另一个实施方案中,扩张器370可包括磁性特征部以与拉环354接合,以提供足够的力来将末端351倒置成其倒置的漏斗形状。
在一些示例中,扩张器370可包括内腔575,远侧段377终止于近侧段376远侧的远侧端部278中,其中该远侧段和该内侧段具有类似的直径。扩张器370的接触元件371可以是扩张器的凹口或槽或凹槽或凹陷部的远侧端部,而接触元件372可以是同一凹口或槽或凹槽或凹陷部的近侧端部。在一些示例中,元件371可以是磁性的以便夹持环354(例如,通过由一种或多种含铁材料构造环354),并且在扩张器370回缩期间朝近侧拉动环354。可联接到端部358的环354可相对于所述凹口或槽或凹槽或凹陷部和/或其周围定位在接触元件之间。如所布置的,远侧段377平移拉环354,直到在远侧段352的近侧端部358处或附近对齐,从而倒置段352以形成图4B的无创伤漏斗形状。在一些示例中,远侧末端351的近侧端部353和拉环354可通过两者间的对应磁性联接在展开状态下锁定在一起。远侧末端351的近侧端部353和拉环354可各自包括具有异形的脊和/或互锁凹陷部的平面配对表面。例如,配对表面可以是渐缩的,以用于互锁的渐缩锁定相互作用。在其他示例中,配对表面可被构造成能够卡扣锁定在一起。
图5A描绘了导管450的具有扩张器470的另一个可倒置可扩张末端451。末端451可包括近侧段455和从近侧段455延伸并且基本柔性的远侧段452。远侧段452的近侧端部453可定位在远侧末端451的外表面上。类似于先前所述的末端,拉环454可邻近或刚好位于段455的远侧,这样环454可用于拉动段452并使得该段倒置成图5A的漏斗形状。在一些示例中,远侧段452的近侧端部453可在拉环454的外部。就这一点而言,将环454和附接的近侧端部453如图所示对齐到导管450的OD和定位膜结构,该定位膜结构附接到拉环的远侧面。继而该附接允许膜在倒置时朝远侧平滑地渐缩。
图5B描绘了导管550的具有本公开的扩张器570的另一个可倒置可扩张末端551。如图所示的远侧末端551可与导管主体550成一整体,包括与段552成一整体的段555。该示例的扩张器570还可具有在接触元件573处或周围的最大直径,该接触元件在此处可以是向外凸起部或环状挤出物,其被构造成布置在环554内部并且与从元件573朝远侧渐缩的元件形成过盈配合。如图所示,环554适配在导管主体550下方,膜结构的近侧面与导管主体550的远侧面成一直线或与其成一整体,并且该膜结构附接在拉环554下方。继而该附接允许膜在倒置时朝远侧平滑地渐缩。
图5C描绘了导管650的处于具有扩张器670的展开构型的另一个可倒置可扩张末端651。如图所示,扩张器670可包括位于近侧段676远侧的远侧段677,该远侧段直径大于近侧段676。直径可以是逐渐变化的以形成椭圆形或其他弯曲形状。远侧段677可包括接触元件671,该接触元件从远侧段677径向向外延伸并且被构造成接触并朝近侧平移拉环654,直到在近侧段655的远侧端部处或附近对齐。可以看出,元件671可以是向外成角度的闩锁。例如,如图所示的元件671可包括朝远侧成角度,以便在其与扩张器670的外表面之间形成锐角。该闩锁继而可防止段652的远侧端部以漏斗形状从其脱离,如图所示。
图5C描绘了导管650的处于具有扩张器670的展开构型的另一个可倒置可扩张末端651。如图所示,扩张器670可包括内腔675,远侧段677具有位于近侧段676远侧的远侧端部678,该远侧段直径大于近侧段676。直径可以是逐渐变化的以形成椭圆形或其他弯曲形状。远侧段677可包括接触元件671,该接触元件从远侧段677径向向外延伸并且被构造成接触并朝近侧平移拉环654,直到在近侧段655的远侧端部处或附近对齐。可以看出,元件671可以是向外成角度的闩锁。例如,如图所示的元件671可包括朝远侧成角度,以便在其与扩张器670的外表面之间形成锐角。该闩锁继而可防止段652的远侧端部以漏斗形状从其脱离,如图所示。
图5C描绘了导管650的处于具有扩张器670的展开构型的另一个可倒置可扩张末端651。如图所示,扩张器670可包括内腔675,远侧段677具有位于近侧段676远侧的远侧端部678,该远侧段直径大于近侧段676。直径可以是逐渐变化的以形成椭圆形或其他弯曲形状。远侧段677可包括接触元件671,该接触元件从远侧段677径向向外延伸并且被构造成接触并朝近侧平移拉环654,直到在近侧段655的远侧端部处或附近对齐。可以看出,元件671可以是向外成角度的闩锁。例如,如图所示的元件671可包括朝远侧成角度,以便在其与扩张器670的外表面之间形成锐角。该闩锁继而可防止段652的远侧端部以漏斗形状从其脱离,如图所示。
然而,元件671不限于此,而是可相对于扩张器670的外表面基本上正交。元件671还可位于段652的近侧端部653的远侧,由此端部653可定位在段655的外表面上。在一些示例中,在塌缩状态下的远侧段652的中点转变为位于导管650远侧的在展开状态下的漏斗形状的最远侧花瓣末端。就这一点而言,系统600可包括形成漏斗形状的一个连续花瓣或多个径向分离的最远侧花状花瓣末端。在其他示例中,相比于图5A至图5B的圆化漏斗形状,系统600的漏斗形状可更尖或不那么无创伤。
图6A描绘了本公开的导管750的具有扩张器770的处于展开构型的另一个可倒置可扩张末端751。如图所示,扩张器770的接触元件771位于末端751的远侧并且附接到该末端,并且为凝块捕获和/或其中支架取栓器的使用提供相对平滑的过渡。通过如相对于末端751所示布置扩张器770,系统700的内径由于段752的远侧端部758至少部分地定位在该系统700的内径内而减小。有利的是,拉环754的近侧面邻接导管主体750的远侧面,并且膜/框架可附接在拉环754下方。在该示例中,近侧膜结构附接到导管750的OD,这允许膜在倒置时朝远侧平滑地渐缩。
图6B描绘了本公开的导管850的具有扩张器870的处于展开构型的另一个可倒置可扩张末端851。如图所示,扩张器870的接触元件871位于末端851的远侧并且附接到该末端。此处,由于在展开的漏斗形状中段852的末端858与段855同轴,因此段855、852之间的内径基本类似(如果不相等的话)。如图所示,与末端751相比,末端851还可在漏斗形状中包括相对更尖锐的边缘。此处,有利的是,环854的近侧面邻接导管主体850的远侧面,并且膜/框架附接到环854的远侧面。此外,这导致漏斗和附接到导管750的OD的近侧膜结构的更尖锐倒置。
图6C描绘了本公开的导管950的具有扩张器970的处于展开构型的另一个可倒置可扩张末端951。如图所示,扩张器970的接触元件971位于末端951的远侧并且附接到该末端。具体地讲,远侧接触元件971从远侧段977径向向外延伸并且被构造成接触并朝近侧平移拉环954,直到在远侧末端951的近侧端部953处或附近对齐。元件971的近侧端面可被布置成接触环954,该环可位于段952的远侧端部958的远侧面上。此处,环954的近侧面邻接导管主体950的远侧面,并且膜/框架附接到环954的远侧面,并且产生了漏斗的相对更尖锐倒置。
如图所示,端部958可具有有利于环954和端部958之间的接触的偏置弯曲部。在所示的漏斗形构型中,该弯曲部可在朝远侧返回之前朝近侧延伸,以迫使环954与元件971的近侧面联接。在一些示例中,元件971可包括或可以是向外延伸的环状构件。元件971还可包括半圆形状。
图7A至图7C示出了末端851,但其具有先前在图6B中描述的修改的、更尖锐的漏斗形状,该末端从图7A的塌缩的管状状态转变至图7C的展开的漏斗形状。具体地讲,扩张器870在其相应的接触元件处联接到环854。图7B示出了扩张器870已回缩第一距离,使得段852在其中间部分开始倒置时开始其扩展。图7C示出了环854已通过扩张器870朝近侧平移直到接触段855的远侧面。继而段852完全倒置成漏斗形状。此处,环854具有与段855类似的直径,使得在扩展状态时环854与段855之间形成邻接部。有利的是,导管850的近侧端部和远侧端部之间的内径和外径的这种最小差异优化了该导管相对低的外部轮廓和大的内径。
图8A至图8C示出了根据本公开的方面的通过结合扩张器1070来倒置而展开的本公开的导管1050的另一个可扩张可倒置末端1051。具体地讲,末端1051被示出为从图8A的塌缩管状状态转变至图8C的展开的漏斗形状。元件1071的近侧面联接到环1054。图8B示出了扩张器1070已回缩第一距离,使得段1052在其中间部分开始倒置时开始其扩展。在图8B的状态下,段1052在倒置之前可包括大致圆锥形状。图8C示出了环1054已通过扩张器1070朝近侧平移直到被布置成靠近段1055的远侧面(例如,此处在段1055内部)。继而段1052完全倒置成图8C所示的漏斗形状。环1054可具有小于段1055的内径的直径,使得在扩展状态时环1054与段1055的内表面之间形成邻接部。
在一些示例中,扩张器1070的段1077可以是超软的以提供与拉环1054的足够过盈作用,以传递足以使得段1052扩展并倒置的径向力,如图8A至图8C之间所示。在一些示例中,段1076可以是高度柔性的,使得其不会显著地增加系统的刚度。为了实现这一点,段1076可包括相对薄的壁并且可包括纵向绳状纤维以防止其在张力下拉伸。
在一些示例中,一旦已形成图8C所示的倒置漏斗形状,扩张器1070和环1054之间的过盈力便可能不足以使环1054更朝近侧移动,并且扩张器1070的末端(例如,段1077)挤压穿过环1054。当段1077的尺寸被设定成与段1055的管腔具有小间隙时,段1077可容易地回缩通过导管系统1000。在一些示例中,扩张器1070可被重新推进以朝远侧推动环1054并且将漏斗形状反倒置成图8A的塌缩管状护套。在一些示例中,尽管未示出,但一旦在血管内倒置并扩展,便可提供第二更刚性的扩张器以用于使末端1051塌缩,其中可存在第一扩张器1070。
图9A至图9B示出了导管1150的另一个可扩张可倒置末端1151。具体地讲,图9A示出了处于具有扩张器1170的扩展的漏斗形构型的末端1151。图9B示出了处于相同构型但扩张器1170已回缩并从末端1151移除的末端1151。此处,元件1171的远侧面联接到端部1158的近侧面,使得末端1151被压缩穿过环1154。继而端部1158的内径联接到环1154。在该示例中,如所述和所示的那样将端部1158联接到环1154允许末端1151形成用于抽吸的凝块和/或支架取回器装置进入的逐渐平滑的弯曲部。此外,将环1154的尺寸设定成小于段1155的主要导管主体内径允许拉环1054在扩张器1170的段1177压缩穿过该环时楔入或锁定就位。
图10A至图10B示出了根据本公开的方面的末端1251,由此图10A示出了在管状构型下延伸时的末端1251,并且图10B是末端1251在环1254已回缩以使得段1252扩展并倒置成漏斗形状时的特写。环1254可包括与定位在段1255的远侧端部处的内渐缩部1259匹配的外渐缩部。如示出了联接的渐缩部的特写的图10B中更清楚地示出,对应的渐缩部可联接和/或锁定在一起。虽然图10A至图10B中仅示出了渐缩表面,但可设想的是,可根据需要或要求使用其他互锁表面。
图11A至图11B描绘了导管1350的另一个可扩张末端1351,其从图11A的具有扩张器1370的第一管状构型开始,然后到图11B的扩张的倒置的漏斗形状的展开构型。扩张器1370可包括接触元件1371,该接触元件具有扩张器1370的最大直径,然后从该接触元件逐渐朝远侧渐缩,以用于凝块的逐渐径向压缩。此处,环1354可具有与段1355的直径类似的直径,使得其间的邻接部可防止环1354朝近侧移动到段1355的管腔中,如图11B所示。段1352的远侧端部1358附接在环1354的内径内,这在端部1358和/或环1354与扩张器1370的元件1371之间提供过盈配合。有利的是,在该示例中,段1355和环1354之间的内径差异较小,使得可较少地限制凝块进入段1355的管腔。
另外,如图所示,通过折叠段1352以从环1354的内径朝远侧延伸并且倒置以在环1354的外径上朝近侧延伸,段1353可扩展和倒置以形成用于无创伤漏斗的圆化特征部,该无创伤漏斗被构造成与血管壁相互作用并与其密封。
如果末端1351被制造成刚性的,则其将形成过大的圆形轮廓并且在塌缩以通过外部球囊引导件或长引导护套递送时可能产生扭结。该扭结还可阻止末端1351在展开的漏斗形构型下形成逐渐渐缩部,并且可在回缩期间在导管管腔中形成支架取栓器的障碍点。因此,将末端1351构造成具有柔性部分可允许其首先在塌缩构型下形成软的可压缩圆化特征部,该特征部将恢复以形成从环1354的内径朝远侧延伸的逐渐渐缩部以有助于在抽吸期间压缩凝块并且提供用于在回缩到导管管腔中期间使支架取栓器塌缩的无阻碍路径。
图12A描绘了一个可扩张可倒置末端1451的示例性构造,其可包括具有近侧段1447、中间段1445和远侧段1443的编织物。中间段1445可包括从近侧延伸到与远侧段1443的转变点的细丝,然后这些细丝倒置以朝近侧往回延伸,从而形成编织式样。远侧段1443可包括以螺旋构型从近侧延伸到远侧的细丝和/或可具有足够的径向力以径向向外推动近侧段1447,同时可适形并以无创伤方式适应各种血管尺寸。螺旋式样可允许比编织物更宽泛的血管尺寸范围,因为螺旋线将产生能够比编织式样更容易调节的螺旋式样。远侧段1443可在段1445、1443之间的转变处或围绕该转变处周向延伸,以有助于在血管壁处限定不太圆化的倒置接缝。
图12B至图12D描绘了根据本公开的之前扩展并倒置成漏斗形状的末端1451的视图。具体地讲,图12C是具有示例性涂层(尽管不一定需要涂层)的末端1451的侧平面视图,而图12D是段1451的前平面视图,并且图12B是段1451的后平面视图。如图12D所示,段1443及其螺旋构型可在倒置期间将段1443转换成螺旋。在图12C中还显而易见的是,沿着较低虚线描绘了与在使用期间可与血管壁相互作用的圆化倒置接缝相比更尖锐的倒置接缝设计的倒置接缝。图12B示出了形成编织物的完整性并且在段1445、1443之间的转变点处提供倒置铰链的段1447和1445。尽管未示出,但可以设想的是,如本公开所述的涂层或膜可以根据需要或要求与末端1451一起使用。
图13描绘了一个可扩张可倒置末端1551的示例性构造,其可包括具有近侧段1547、中间段1545和远侧段1543的编织物,由此末端1551的编织物可从近侧端部延伸到远侧端部。末端1551可提供更圆化的倒置接缝,该倒置接缝可在使用期间与血管壁相互作用。
图14A描绘了一个可扩张可倒置末端1651的示例性构造,其可包括具有近侧段1647、中间段1645和远侧段1643的编织物。段1639在段1647的近侧,并且部分1641表示每个段之间的转变。段1647可以是相对刚性的,段1645可以是相对柔性的,并且段1643可以包括相对于其细丝的螺旋构型。中间段1645继而可被构造成在末端1651的倒置步骤期间将径向力分布在较大区域上。处于中间部分的相对柔性的中间段1645还可在倒置期间降低结构拐力,尤其是在薄型脉管的额外约束下,从而减小由该结构施加的径向力和潜在的脉管创伤。
图14B至图14D描绘了根据本公开的之前扩展并倒置成漏斗形状的末端1651的视图。具体地讲,图14C是末端1651的侧平面图,而图14D是段1651的前平面图,并且图14B是段1651的后平面图。如图14D所示,段1543及其螺旋构型可在倒置期间将段1543转换成螺旋。在图14C中还显而易见的是,圆的下拐角段1645的倒置接缝可在使用期间与脉管壁相互作用。图14B示出了形成编织物的完整性并且在段1645、1643之间的转变点处提供倒置铰链的段1647和1645。可通过将细丝热定形为在中心处具有比近侧端部和远侧端部更大的直径以促进变形来施加倒置铰链,该膜具有足够的抗扩展性以将放大的直径保持为与塌缩构型中的近侧段和远侧段一致的基本管状形状。这可用非形状记忆材料通过使用尺寸过大的编织物并通过分别附接装置到远侧拉环和近侧导管主体上减小远侧直径和近侧直径(例如,回流夹套材料、粘合剂或通过限制环)来完成。尽管未示出,但可以设想的是,如本公开所述的涂层或膜可以根据需要或要求与末端1651一起使用。
图15A至图16F描绘了根据本公开的可扩张可倒置末端1751的视图。在图15A中,末端1751可包括具有段1755和段1752的编织构造。段1752可包括近侧部分1751和远侧部分1759,它们各自具有编织式样(例如,相同的式样或不同的式样)。转变部分1753可定位在段1755和段1752之间。在末端1751的一些示例中,编织线可环绕环1754以允许编织物在倒置期间围绕环1754旋转,这可有利于将远侧段1752完全倒置。为了进行示意性的说明,将图15A严格地表示为部分A、B、C。应当理解,编织线可从A至C再至A成环。然而,段1751不限于此,并且编织线也可从A至B再至A成环。在其他示例中,编织线可从A至B再至A至C又至A成环。在其他示例中,编织线可从A至C成环,以及这些各种编织线成环构型的任何组合。在一些示例中,末端1751的至少一根编织线可恰好在环1754的近侧扭转以将环1754保持在适当位置。
转到图15B,以扩展倒置的漏斗形构型示出了末端1751的特写。在此,可以看出,当环1754已朝近侧平移时,段1752已倒置并扩展,如本公开的先前示例性远侧末端中所示。图15C是图15B的类似视图,但其中移除了芯轴和/或扩张器,并且仅留下末端1751处于扩展倒置的漏斗形构型。
图16A是图15A的部分A的近距离视图,示出了如前所述的编织线。图16B是图15A的部分B的近距离视图,示出了如前所述的编织密度或PPI变化。图16C是图15A的部分C的近距离视图,示出了如前所述的环绕拉环的编织线。图16D是图15A的截面C沿中心线的近距离剖视图,其中示例性扩张器1770与环1754联接。如图所示,扩张器1770具有周向肋以夹持拉环1754。图16E是图15A的部分C沿中心线的近距离剖视图,其中另一个示例性扩张器1770与环1754联接,由此扩张器1770包括朝远侧折叠以有助于径向压缩以在达到预先确定的力之后挤压穿过环1754的邻接特征部。图16F是图15A的部分C的近距离透视图,示出了如前所述的成环并与环1754联接的编织线。本示例中的细丝可从近侧延伸到远侧,并且可在远侧端部处往回成环。环1754可穿过成环末端,使得当被倒置时,成环细丝围绕环1754旋转以将向外的面倒置成径向面向内,从而形成面向远侧的漏斗,如图所示。
通过添加合金元素(诸如钯、铂、金等),通过施加不透射线化合物,或通过在导管和装置中的一个或多个上放置不透射线标记物,可有助于在部署本文所公开的导管系统中的任一个期间的可见性。合适的实践频繁地与其他装置和植入物结合使用,并且在本领域中是熟知的。例如,可将不透射线化合物结合到可结合到远侧末端中的覆盖件上,或者可在末端的远侧端部处、上和/或附近添加一个或多个不透射线标记物。另外,编织线中的一个或多个可包括DFT线,该DFT线包括具有NiTi外层的铂芯(用于射线不透性)。使用此类标记物,医师将能够目视确认开口已完全倒置并扩展到脉管壁。
在本公开的导管系统中使用的抽吸源可以是手动注射器或小位移真空泵,并且抽吸被引导至本文所公开的导管系统中的任一个的远侧末端。可通过远侧末端的倒置漏斗形状与脉管壁、外导管的内壁的密封动作来实现有效抽吸,和/或通过使用流量限制器/密封件来实现有效抽吸。然而,在一些情况下,不可能单独使用抽吸以迄今为止的任何导管系统移出或完全取回凝块。就这一点而言,可以设想的是,血栓切除装置可与本公开的导管系统一起使用,并且可以是可与抽吸凝块取回导管一起供应或分离的许多可商购获得的产品中的任一种。结合本公开的扩展开口导管系统使用血栓切除装置对于增加首过成功的可能性具有若干益处。血栓切除装置可在抽吸期间支撑脉管的管腔,使得管腔不太可能在负压下塌缩,并且如果凝块包括可以其他方式碎裂的一系列刚性部分和柔软部分,则血栓切除装置将把凝块保持在一起。血栓切除装置还可允许使用者夹紧凝块,否则凝块将不完全进入导管末端与血栓切除装置之间的凝块取回导管的管腔。当凝块取回导管、凝块和血栓切除装置通过脉管系统和外导管回缩成一体时,被夹紧的凝块将不太可能从凝块取回导管移出。
图17是流程图,每个流程图包括用于利用本公开的一个系统执行手术的方法步骤。方法步骤可通过本文所述的示例性系统、装置和/或设备的任一种或通过本领域的普通技术人员已知的方式来实施。
参见图17中概述的方法1700,步骤1710包括将本公开的任何导管推进到目标部位。步骤1720包括通过至少部分地在导管的管腔内的扩张器回缩导管的远侧末端,并且优选地移除扩张器以使回缩到导管中的凝块上的抽吸流速和力最大化,从而使得远侧末端扩展并倒置成漏斗形状。
在方法1700的一些示例中,可撤回扩张器并且然后可通过导管施加抽吸,取决于使用者已如何部署流量限制和/或密封,以刺激凝块进入导管的开口中。如果仅抽吸不足以移出和捕获血栓,或者如果在初始抽吸和移出期间需要对凝块的附加夹持,则可将具有机械血栓切除凝块取回装置的微导管推进到目标。然后可使用本领域通常已知的任何方法来部署机械血栓切除装置以捕获凝块。抽吸可在整个该步骤期间或者以使用者选择的间隔持续,以防止血液回流并保持对凝块的紧密夹持。在一些示例中,用支架取回器抽吸和拉动凝块对于增加首过成功的机会可能是最佳的。
在方法1700的一些示例中,所捕获的凝块和凝块取回导管可从患者体内撤出,或者凝块取回导管可留在原位以在机械血栓切除凝块取回装置与凝块一起从患者体内撤出时保持接近。如果在抽吸源和/或血栓切除装置中观察到凝块并且凝块取回导管中的流动未被阻塞,则该步骤还可涉及使用已知的技术在低压下通过系统小心地注射造影剂以确定脉管是否为开放的。如果脉管是开放的,则可移除凝块取回导管。如果仍然存在阻塞,则可另外多次重复抽吸、血栓切除术或这些的组合,直到脉管为开放的。
本公开不必要限于所描述的示例,这些示例的构造和细节可变化。术语“远侧”和“近侧”在整个前述描述中使用,并且是指相对于治疗医师或使用者的位置和方向。同样,“远侧”或“朝远侧”是指远离医师的位置或在远离医师的方向上。类似地,“近侧”或“朝近侧”是指靠近医师的位置或在朝向医师的方向上。此外,除非上下文另有明确说明,否则单数形式“一个”、“一种”和“该”包括复数指代。
如本文所用,指代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。
在描述示例实施方案时,为了清楚起见,采用了术语。在不脱离本公开的范围和精神的情况下,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,可按照与本文所述的顺序不同的顺序执行方法的一些步骤。类似地,还应当理解,可省略方法步骤中的一些方法步骤。
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。为清楚和简洁起见,并未列出所有可能的组合,并且此类修改对于本领域技术人员而言通常是显而易见的,并且旨在落入所附权利要求书的范围内。
Claims (20)
1. 一种能够致动到展开状态的导管系统,包括:
导管主体,所述导管主体包括管腔;以及
扩张器,所述扩张器至少部分地定位在所述管腔内,所述扩张器的远侧端部能够释放地连接到所述导管主体的远侧末端,所述扩张器能够回缩以扩展并倒置所述远侧末端并且形成在所述展开状态下的漏斗形状。
2. 根据权利要求1所述的系统,所述远侧末端包括:
近侧段;以及
远侧段,所述远侧段从所述近侧段延伸并且为基本柔性的,所述远侧段的近侧端部从所述近侧段延伸并且包括邻近和/或连接到所述远侧段的远侧端部的拉环。
3.根据权利要求2所述的系统,在塌缩状态下的所述远侧段的中点转变为位于所述导管主体远侧的在所述展开状态下的所述漏斗形状的最远侧无创伤端部。
4.根据权利要求2所述的系统,在塌缩状态下的所述远侧段为基本管状的并且在所述展开状态下所述远侧段包括所述漏斗形状,由所述漏斗形状在所述远侧端部和所述拉环之间形成气垫。
5.根据权利要求2所述的系统,所述远侧段被分成近侧编织物部分和远侧螺旋部分。
6.根据权利要求2所述的系统,所述扩张器包括:
近侧段;
远侧段,所述远侧段位于所述近侧段的远侧,所述远侧段具有大于所述近侧段的直径,所述远侧段包括接触元件,所述接触元件从所述远侧段径向向外延伸并且被构造成接触并朝近侧平移所述拉环,直到在所述远侧段的所述近侧端部处或附近对齐。
7.根据权利要求6所述的系统,所述接触元件包括与所述导管主体的所述远侧末端的所述远侧端部的过盈配合。
8.根据权利要求6所述的系统,所述扩张器的所述远侧段在所述接触元件处具有最大直径,并且从所述接触元件到所述远侧段的所述远侧端部78逐渐减小。
9.根据权利要求6所述的系统,所述扩张器的所述远侧段在所述接触元件处具有最大直径,并且从所述接触元件到所述近侧段和所述远侧段之间的接合部73渐缩。
10.根据权利要求6所述的系统,所述扩张器的所述近侧段为高度柔性的或比所述扩张器的所述远侧段明显更柔性的。
11.根据权利要求10所述的系统,还包括:
基本柔性的段,所述基本柔性的段朝所述较刚性的远侧段的远侧延伸,所述基本柔性的段为短鼻部。
12.根据权利要求6所述的系统,所述扩张器的所述近侧段包括纤维增强系统以阻止伸长。
13.根据权利要求2所述的系统,其中所述远侧末端的所述近侧端部和所述拉环在所述展开状态下锁定在一起。
14.根据权利要求2所述的系统,其中所述远侧末端的所述近侧端部和所述拉环各自包括被构造成卡扣锁定在一起的配对表面。
15.根据权利要求2所述的系统,所述远侧末端被构造成在倒置以形成所述漏斗形状之前首先扩展至基本圆锥形状。
16.根据权利要求1所述的系统,所述远侧末端包括编织物,所述编织物包括近侧部分、中间部分和远侧部分,其中所述编织物包括以螺旋构型从近侧部分延伸到远侧部分的细丝,其中所述远侧部分包括足够的径向力以径向向外推动所述近侧部分同时被构造成以无创伤方式适应各种血管尺寸。
17.一种在血管中倒置可扩张导管的方法,包括:
将所述导管推进到目标部位;
通过至少部分地位于所述导管的管腔内的扩张器回缩所述导管的远侧末端,使得所述远侧末端扩展并倒置成漏斗形状。
18.根据权利要求17所述的方法,还包括:
通过所述漏斗形状限制所述血管中的流量。
19.根据权利要求17所述的方法,还包括:
从所述导管撤出所述扩张器;
通过所述导管抽吸以刺激血栓进入所述漏斗形状的开口中;以及
从患者中撤出带有所捕获的血栓的所述导管。
20. 根据权利要求17所述的方法,还包括:
用机械血栓切除装置捕获闭塞血栓;以及
将所述血栓切除装置撤出到所述导管的所述漏斗形状中。
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2020
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CN112472208A (zh) | 2021-03-12 |
KR20210031630A (ko) | 2021-03-22 |
US20230041285A1 (en) | 2023-02-09 |
US11529495B2 (en) | 2022-12-20 |
US20210069468A1 (en) | 2021-03-11 |
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