CN113813012A - 双通道血栓切除装置 - Google Patents
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Abstract
本发明题为“双通道血栓切除装置”。一种用于从血管中移除凝块的装置可具有双层,其中内部可膨胀构件在外部可膨胀构件内延伸。内部可膨胀构件可分成一个或多个节段,其中近侧节段具有凝块夹紧结构,该凝块夹紧结构被构造成在夹紧结构和外部导管之间夹紧凝块。内部构件的远侧流动通道节段可被构造成形成穿过凝块的流动通道,以将血液恢复到下游脉管系统。外部可膨胀构件的撑条可形成闭孔,这些闭孔在近侧部分中不是完全周向的,以允许凝块在夹紧结构内部通过并接合夹紧结构,并且在远侧部分中是完全周向的,以支撑血管用于使凝块分离。装置的远侧端部处的保护元件可防止凝块碎片逃脱。
Description
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,本公开涉及用于从血管中移除凝块的凝块取回装置。
背景技术
本公开涉及从血管中移除急性堵塞物的装置和方法。急性阻塞物可包括凝块、错位装置、迁移装置、大栓塞等。当部分或全部血栓从血管壁脱离时,发生血栓栓塞。这种凝块(现在称为栓塞)随后沿血流方向运送。如果凝块滞留在大脑脉管系统中,则可能导致缺血性脑卒中。如果凝块起源于静脉系统或心脏右侧并滞留在肺动脉或其分支中,则可能导致肺栓塞。凝块也可不以栓塞的形式释放,而是在局部形成并堵塞血管,这种机制在形成冠状动脉堵塞中较为常见。本文的装置和方法特别适用于从患有急性缺血性卒中(AIS)的患者的脑动脉、从患有肺栓塞(PE)的患者的肺动脉、从患有心肌梗塞(MI)的患者的冠状动脉或移植血管、以及从其中凝块引起闭塞的其他外周动脉和静脉血管中移除凝块。
存在可使得难以向目标部位传送装置的许多进入挑战。在进入涉及导航主动脉弓(诸如冠状动脉或脑堵塞)的情况下,一些患者的弓构型使得难以定位引导导管。在接近大脑的动脉中,曲折性挑战甚至更严重。例如,在颈内动脉的远侧端部处,装置将不得不在仅几厘米的行程中快速连续地导航具有若干极端弯曲的血管节段,这种情况并不罕见。在肺栓塞的情况下,可以通过静脉系统并然后通过心脏的右心房和心室获得进入。右心室流出道和肺动脉是脆弱的血管,其很容易被不灵活或高规格的装置损坏。由于这些原因,期望凝块取回装置与薄型且灵活的通路和支撑导管尽可能兼容。
凝块可能滞留在的区域中的脉管系统通常是脆弱且纤弱的。例如,神经血管比身体其他部位的类似尺寸的血管更纤弱并且位于软组织床中。施加在这些血管上的过大拉力可导致穿孔和出血。肺血管大于大脑脉管系统的血管,但其性质也很纤弱,特别是更远侧血管。
支架状凝块取回装置越来越多地用于从急性中风患者的脑血管中移除凝块。这些装置通常依赖于钉扎机构,以通过将凝块捕集在自扩张的支架状主体与血管壁之间来抓取凝块。这种方法有许多缺点。
支架状凝块取出器依赖于其向外径向力来保持其对凝块的抓持。该压缩力将倾向于使凝块脱水,这继而可增加其摩擦系数,从而使得其更难以从血管中分离和移除。如果径向力太低,则支架状凝块取回器将失去其对凝块的抓持,但如果径向力太高,则支架状凝块取出器可能损坏血管壁并需要过大的力才能撤回。因此,具有足够径向力以处理所有凝块类型的支架状凝块取回器可能导致血管创伤和严重的患者伤害,并且具有适当径向力以保持无创伤的支架状凝块取回器可能无法有效地处理所有血栓切除情况中的凝块类型。将凝块钉扎在支架状凝块取回器和血管壁之间还导致在凝块被移除时抵靠凝块的侧面的高剪切力,从而潜在地释放凝块的碎片。如果这些碎片未被装置保持,则它们可能被释放,从而导致远侧脉管系统中的进一步阻塞。
由于其撑条元件彼此连接的方式导致撑条在回缩期间被置于张力下,所以某些常规支架状凝块取回器设计在被置于血管弯曲部中处于张力下时也无法很好地保持其膨胀形状。该张力是由于装置与血管之间的摩擦引起的,并且如果施加附加的负荷(诸如由凝块提供的阻力),则该张力增加。这可能导致失去对凝块的抓持,因为支架状凝块取回器在曲折血管中的弯曲部分附近朝近侧撤回,其中所捕集的凝块可能逃脱。在弯曲部处,该位于弯曲部的外侧的撑条被置于比内侧的撑条更高的张力下。为了获得最低可能的能量状态,凝块取回装置的外表面朝向弯曲部的内表面移动,这减小了撑条中的张力,但也减小了装置的膨胀直径。
此外,当尝试移除长凝块时,比凝块短的常规装置不太可能能够在部署时恢复通过闭塞的区域的流动。因此,跨凝块的压力梯度仍然是其移除的显著障碍。简单地将此类装置制造为更长的可能会使得其难以通过曲折的解剖结构进行追踪并且可对脉管系统造成创伤,从而采取更多的力来撤回并可能卡住装置柱,从而需要手术移除。
在寻求手术效率时,还使用了具有多个主体的装置。此类装置可具有能够支撑靶血管的外部主体以及用于嵌入和捕集凝块的内部主体。这些装置可很好地与凝块接合并使凝块分离,但具有更大且通常更硬的撑条网络可潜在地使其更难以使装置回缩并将凝块部分地或完全地重新套入外部导管内。在该过程中外部主体的构件的压缩可能妨碍或甚至松开内部主体对所捕集的凝块的抓持,尤其是对于较长的凝块或在通过夹紧动作在装置和外部导管的远侧末端之间保持抓持的情况下。当装置在回缩期间部分或完全塌缩时,外部主体的较大膨胀形状可导致外部主体撑条冲击或偏转内部主体的那些撑条。
给定装置的有效性也是重要的,因为出于许多原因,医师通常需要进行多次通过以便完全移除栓塞。每次凝块取回装置被撤回时,都失去到达目标部位的通路。因此,可能有必要重新推进导丝和微导管以接近并重新穿过凝块,并且然后移除导丝并使凝块取回装置推进通过微导管。将导丝和微导管导航至凝块可能需要相当长的时间,尤其是如果血管是曲折的情况下。附加的时间和装置操纵增加了患者所暴露的并发症的风险,突出了有效和高效装置的重要性。
对于任何装置需要克服上述挑战以便在移除凝块、恢复血流和促进良好患者结果方面提供高水平的成功。本发明的设计旨在提供解决上述缺陷的改进的凝块取回装置。
发明内容
本文的设计可针对用于从身体血管中移除凝块的凝块取回装置。该装置可具有形成细长内部主体的撑条框架,该细长内部主体具有近侧端部、远侧端部和纵向轴线。细长内部主体可被分成从用于操纵装置的近侧轴朝远侧延伸的一个或多个节段。近侧节段可具有凝块夹紧结构,该凝块夹紧结构在被约束在外部导管内时具有塌缩的递送构型,在部署在目标部位处时具有膨胀的凝块接合构型,并且具有夹紧结构被至少部分地约束在其中的凝块夹紧构型。当装置从接合部署构型转变时,凝块夹紧结构可被构造成在处于凝块夹紧构型时夹紧并抓住凝块。
凝块夹紧结构可采用多种形式,诸如以起伏或螺旋方式布置的平坦图案。在一个示例中,夹紧结构包含相邻节段的阵列。这些节段可以是由较高密度的环邻接的低撑条密度的节段,或者在不同的纵向位置处变化形状,使得在凝块中由至少两个相邻节段施加的径向力彼此不同。在另一个示例中,夹紧结构可具有一系列凝块接收孔。这些孔可由在冠部之间延伸的一个或多个柔性撑条组成,使得当撑条处于压缩状态时,这些孔能够收缩孔中的凝块的部分。这些模式允许微导管或外部导管在夹紧结构的近侧端部上方推进,以便在装置从膨胀部署构型转变为部分受约束的凝块夹紧构型时,压缩并抓持位于导管的末端与夹紧结构的撑条的至少一部分之间的凝块。
装置的细长内部主体的更远侧节段可为多孔内部通道,该多孔内部通道可固定地连接到凝块夹紧结构的远侧端部。内部通道可包括由多个撑条构成的管状主体,这些撑条限定围绕纵向轴线的内部主体闭孔。这些孔和撑条可被设计成穿透凝块并施加径向力以形成穿过凝块的管腔,并且在部署时恢复到径向膨胀构型的流动。这些孔还可允许凝块的部分通过移位穿过孔开口而逃脱压缩,从而减小施加在血管壁上的径向力,以使血管创伤最小化并减小远侧血管床的拉伸干扰。
该装置可具有双可膨胀构件,由此内部构件和外部构件的特性可彼此独立地定制。在一个示例中,提供具有内部细长主体的外部保持架。外部保持架可与内部细长构件同轴或可径向偏移。外部保持架可比内部细长主体膨胀到更大的程度,并且被构造成与目标血管壁并置并支撑目标血管壁。内部细长主体可基本上布置在外部保持架的管腔内。内部主体与外部保持架之间的径向膨胀差异可限定两者之间的接收空间,凝块可被接收在该接收空间中。
与内部细长构件类似,外部保持架还可具有一个或多个节段。保持架可具有近侧第一支架节段,该近侧第一支架节段具有撑条框架,从而形成纵向布置的一个或多个近侧可膨胀主体。近侧可膨胀主体可由形成围绕纵向轴线间隔开的一个或多个支撑臂的非周向的闭孔制成,使得在相邻臂之间存在大周向间隙。例如,外部保持架的第一支架节段可具有两个沿直径相对且间隔开180度的支撑臂。
外部保持架还可具有远侧第二支架节段,该远侧第二支架节段具有形成纵向布置的一个或多个远侧可膨胀主体的撑条框架。类似于第一支架节段,第二支架节段可具有围绕纵向轴线的闭孔网络。第二支架节段的远侧可膨胀主体的孔可为完全周向的,以便在所有时钟位置处支撑血管。细长内部主体的远侧节段、多孔内部通道可设置在第二支架节段的管腔内。
外部保持架的第一支架节段和第二支架节段的闭孔可大于内部主体的孔。因此,外部保持架可被构造成在血管中的闭塞凝块内膨胀,使得当保持架膨胀时,该保持架允许凝块迁移到其内的接收空间中。
为了增加装置灵活性,第一支架节段和第二支架节段的可膨胀主体可以铰接方式彼此连接,使得它们可在装置通过脉管系统中的弯曲部推进或回缩时独立地挠曲。另外,第一支架节段和第二支架节段的每个可膨胀主体的孔可具有形成至少一个远侧顶点的撑条,该至少一个远侧顶点不连接至相邻的闭孔。
在另一个示例中,凝块取回装置可具有双层设置,其中内部细长主体设置在多孔外部主体内。内部细长主体可具有近侧凝块接合元件,该近侧凝块接合元件具有受约束的递送构型、膨胀的凝块接合部署构型和至少部分受约束的凝块夹紧构型。凝块接合元件的远侧可以是具有受约束的递送构型和膨胀部署构型的管状内部通道。当膨胀时,管状内部通道可利用径向力来恢复闭塞血管中的血流。
凝块接合元件可具有撑条框架,该撑条框架被构造成在膨胀到部署构型时对凝块施加向外的径向力。向外力的振幅可沿凝块接合元件的长度变化。在一种情况下,径向力遵循大致正弦波形图案。波形图案的振幅在峰上可大致相等,或者其在近侧端部或远侧端部处可不同,以获得对凝块部分的更牢固抓持。例如,峰的振幅可沿凝块接合元件的长度减小,使得其在近侧端部处较高并且在远侧端部处较低。
该装置还可具有居中延伸穿过近侧凝块接合元件和远侧管状内部通道的纵向轴线。凝块接合元件的撑条可为平坦图案或平面的,使得当部署到膨胀状态时,该图案与轴线对齐或围绕轴线对齐。在一个示例中,元件的撑条可形成以盘旋或螺旋形状围绕轴线扭转的平面图案。在单独的示例中,撑条可形成具有高撑条密度区域和低撑条密度区域或纵向不对称区域的多个相邻节段,使得由两个相邻节段施加的径向力彼此不同,以保持对凝块的更好抓持。在附加情况下,凝块接合元件的相邻撑条可在相同或不同方向上具有弯曲或扭转以改变径向力,使得当凝块接合元件移动到凝块夹紧构型时,所捕集的凝块被压缩和夹紧。
双层装置设置中围绕内部细长主体设置的可以是多孔外部主体,其具有非周向的近侧节段和连接到近侧节段的完全周向的远侧节段。外部主体可被设计成使得当从递送导管部署装置时,该外部主体膨胀到大于内部细长主体的径向膨胀的径向程度。当在导管内部折叠时,外部主体所具有的径向尺寸可等于或大于内部主体的径向尺寸。
多孔外部主体的近侧节段和远侧节段可各自具有一个或多个可膨胀主体。可膨胀主体可各自具有形成闭孔的多个撑条。这些孔通常大于例如内部细长主体的孔,使得可膨胀外部主体可对凝块和靶血管施加径向力,同时提供将不阻碍凝块穿过和被内部主体捕集的支架。近侧节段和远侧节段的每个可膨胀主体可具有在至少一个远侧顶点中接合在一起的撑条,该至少一个远侧顶点不与另一个相邻的闭孔连接,从而通过允许每个主体独立地挠曲并对局部力作出反应来增强灵活性。可膨胀主体的其他部分可具有会聚区域,其中撑条与接合相邻主体的中间联接撑条或连接臂相交。
使用该装置取回凝块期间的栓塞风险可通过提供附加到内部细长构件或外部保持架中的一者或两者的远侧碎片保护元件来降低。保护元件可由横跨血管腔朝向装置的远侧端部的网或支架区组成。元件可为三维的,因为其具有深度以及表面积。在一些情况下,纤维或细线用于在元件中提供对装置轮廓或可输送性的影响最小的添加的支架。结合碎片保护元件与内部构件和外部构件两者的支架提供了比单独使用一个构件更有效的过滤器。
在一个示例中,内部细长主体的远侧部分可具有多个撑条,这些撑条被构造为围绕纵向轴线呈体积图案的碎片保护元件。内部细长主体的远侧部分也可具有鼓胀或扩张的撑条框架。
在另选的示例中,碎片保护元件可连接到外部保持架或构件的远端部分或者可以是外部保持架或构件的远端部分的一部分。外部保持架的端部也可通过一系列远侧冠部支架渐缩。外部构件的冠部撑条可以大致圆锥形状构造,使得外部构件作为围绕保护元件的天然阻隔件朝远侧颈缩。撑条还可周向交叉以占据更大的横截面积,或者在网片或编织物中具有股线以增加覆盖率。
一种使用凝块取回装置从血管中取出闭塞凝块的方法可包括提供外部导管的步骤,外部导管具有管状主体和位于外部导管的远侧端部处的衬圈。还可提供一种凝块取回装置,该凝块取回装置具有配合到能够从塌缩递送构型转变为膨胀部署构型的可膨胀元件的细长轴。凝块取回装置可具有内部主体,该内部主体具有连接到更远的流动通道元件的近侧凝块夹紧元件。围绕内部主体布置的可以为外部主体,其中非周向的第一支架节段接合到完全周向的第二支架节段。第二支架节段可具有与第一支架节段的枢转连接件或铰链状连接件,以允许装置适形于脉管系统中的急剧弯曲。
该方法可涉及将凝块取回装置以塌缩构型递送到目标闭塞部,诸如当凝块取回装置被折叠或约束在微导管内时。可使用导丝或本领域中通常已知的其他技术通过导向导管或中间导管将微导管引导至目标部位。可使微导管向前穿过凝块,然后撤回以暴露凝块取回装置并允许其在凝块内膨胀。非周向的第一支架节段中的间隙可允许凝块的至少一部分暴露于内部凝块夹紧元件。类似地,来自完全周向的第二支架节段的膨胀的径向力可使凝块的部分移位通过大的外部孔,使得凝块与流动通道元件接合。流动通道元件的膨胀可打开路径以至少部分地恢复血流,从而使血管再通。
为了继续用于移除凝块的方法,可在沿细长轴推进外部导管时牢牢地保持凝块取回装置的位置,使得外部导管的衬圈与可膨胀元件接合,以在衬圈和夹紧元件之间以压缩形式夹紧凝块的至少一部分。一旦使用者感觉到指示凝块已被夹紧并保持抓持的阻力,就可将外部导管与凝块取回装置和所捕集的凝块一致地从血管移除,同时保持相对位置,使得衬圈保持与凝块取回装置的可膨胀元件接合。然后可将凝块取回装置和夹紧的凝块从患者体内完全移除。
在许多情况下,在取回一些或全部闭塞凝块之后,可通过外部导管注射造影剂以允许更全面评估血管通畅的程度。如果血管中仍存在栓塞物,可使用血栓切除装置进行附加疏通。然后一旦观察到目标血管的充分再通,就可从患者移除任何剩余的装置。本公开的装置提供了使治疗患者所需的导管推进次数最小化的装置,从而在需要多次通过的情况下降低血管损伤的可能性和相关联的血管解剖风险。
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
将参考下面的描述并结合附图进一步讨论本发明的上述方面和另外的方面,其中类似的参考标号指示功能上类似或相同的元件。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为根据本发明的各方面的凝块取回装置的等轴视图;
图2示出了根据本发明的各方面的凝块取回装置的另一个视图;
图3示出了根据本发明的各方面的图2的凝块取回装置的外部保持架;
图4示出了根据本发明的各方面的图2的凝块取回装置的外部保持架的另一个视图;
图5示出了根据本发明的各方面的图2的凝块取回装置的细长内部主体;
图6为根据本发明的各方面的细长内部主体的凝块夹紧结构的撑条结构的放大视图;
图7示出了根据本发明的各方面的凝块取回装置的另选的细长内部主体;
图8为根据本发明的各方面的凝块取回装置的另一另选的细长内部主体的视图;
图9示出了根据本发明的各方面的凝块取回装置的另一个另选的细长内部主体;
图10为根据本发明的各方面的由轴向位置沿凝块夹紧结构施加的径向力的示例性曲线图;
图11a至图11c为示出根据本发明的各方面在目标位置处使用凝块取回装置的一系列视图;
图11d继续了图11a至图11c的系列,其示出了根据本发明的各方面外部导管与凝块夹紧构型中的夹紧结构之间的相互作用;
图11e继续了图11a至11c的系列,其示出了根据本发明的各方面在以凝块夹紧构型夹紧时分离的凝块正从血管中撤回;并且
图12至图13为概述根据本发明的各方面的系统的使用方法的流程图。
具体实施方式
本发明所公开的设计的目的是创建凝块取回装置,该凝块取回装置能够更有效和高效地移除脉管系统中的栓塞物,同时在手术期间保持高水平的可递送性和灵活性。该设计可具有外部可膨胀构件,内部可膨胀构件在该外部可膨胀构件内延伸。本发明所公开的装置共享双层构型的共同主题,其中内部构件具有凝块夹紧捕集能力和外部构件对这种能力的最少干扰。两个构件均可直接或间接地连接到细长轴,并且在装置的远侧端部处构造的远侧网或支架可防止凝块碎片逃脱。该远侧网可以附加到轴、内部或外部构件或它们中的多个。
该双层构造旨在允许凝块通过外部可膨胀构件中的大开口或间隙进入,并且驻留在设置在两个可膨胀构件之间的接收空间中。内部构件的至少一部分可具有比外部构件更致密的支架,使得防止凝块进入其管腔,从而一旦装置部署在凝块上,就在凝块上形成流动通道。
内部可膨胀构件和外部可膨胀构件两者均有利地由这样的材料制成,该材料一旦从高度应变递送构型释放后就能够自动恢复其形状。该材料可以呈多种形式,诸如线、条、片或管。合适的制造工艺可以为激光切割镍钛诺管,然后对所得结构进行热定形和电抛光,以形成撑条框架和连接元件。如本文所述,为这些元件中的每一个设想了一系列设计,并且这些元件中的任一个都可以与任何其他元件结合使用,但为了避免重复,它们不会以任何可能的组合示出。
现在参考附图详细描述本发明的具体示例。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,但这些设计也可适用于其他手术和其他身体通路。
接近血管内的各种血管以达到凝块(无论是冠状血管、肺血管还是脑血管)涉及熟知的手术步骤和许多常规的可商购获得的附件产品的使用。这些产品诸如血管造影材料、旋转止血阀、递送进入导管和导丝广泛用于实验室和医学手术中。当这些产品或类似产品与以下描述中的本发明的公开内容结合使用时,其功能和确切构造未被详细描述。
参见图1,凝块取回装置100可具有细长轴6和在细长轴6的远侧端部处构造的可膨胀结构,该可膨胀结构具有内部构件和外部构件。这些构件可以是外部保持架210和细长内部主体110,以捕集凝块并有利于在凝块取回装置100部署在目标部位处之后恢复通过凝块的血流。外部保持架210可为具有大孔的支架结构,凝块可穿过其中并进入由细长内部主体110和外部保持架之间的环形区域限定的接收空间9。碎片保护元件14可被定位成靠近装置100的远侧端部4附近的外部保持架210的锥形端部218。外部保持架210和细长内部主体110可具有在微导管内用于递送的塌缩构型以及用于凝块取回、流动恢复和破碎保护的膨胀构型。
内部构件和外部构件优选地由超弹性或伪弹性材料制成,诸如镍钛诺或具有高可恢复应变的另一种这样的合金。轴6可以是锥形线轴,并且可以由不锈钢、MP35N、镍钛诺或具有适当高模量和拉伸强度的其他材料制成。轴6和装置100可具有指示带或标记,以在插入期间向使用者指示装置的远侧端部何时接近微导管的端部,或者在手术期间标记装置的终端。这些指示带可通过印刷、移除或掩蔽用于涂覆的轴的区域或在荧光镜透视检查下可见的射线不可透元件而形成,使得它们在视觉上与轴的其余部分区分开。
轴6可涂覆有材料或具有聚合物护套以减少摩擦和血栓形成。涂层或护套可由聚合物、低摩擦润滑剂诸如硅、或亲水性/疏水性涂层组成。该涂层也可施加到外部保持架210和细长内部主体110。
整个本公开的各个附图中所示的双层多直径装置100具有若干优点。具有较小径向尺寸的内部主体110可牢固地嵌入目标凝块中,以便以陡峭的打开角度牢固地抓持,然而较大径向尺寸的外部保持架210可保持与血管壁接触并与血管壁并置,并且在装置朝近侧回缩到直径逐渐增大的血管中时防止凝块朝远侧迁移。
图2中示出了图1的具有双内部和外部可膨胀构件的复合装置100的顶视图。内部主体110和外部保持架210均可为整体结构,其中外部保持架被构造成基本上包封内部主体。外部保持架210的孔用作凝块的入口,并且允许外部保持架在回缩时在基本上平行于凝块从血管中拉出的方向(即,基本上平行于纵向轴线8)的方向上向凝块施加力。这意指施加到脉管系统的向外径向力可保持在最小值。通过构造外部保持架210以便促使凝块横跨于接收空间9,该装置可更有效地使凝块从血管壁脱离。外部保持架210还可具有封闭的远侧端部218,该远侧端部限定了一个表面,该表面被构造成与碎片保护元件14一起用作凝块碎片阻隔表面。
细长内部主体可具有多个区域以提供对凝块的强抓持和强打开力两者从而形成管腔,以在部署时恢复流动。细长内部主体110可具有近侧凝块夹紧节段120,该近侧凝块夹紧节段可提供对凝块的强抓持以用于使凝块从血管脱离的关键初始步骤,使得外部保持架210能够以低径向力构造。
细长内部主体110的远侧节段可为多孔内部通道130,该多孔内部通道被构造成形成穿过凝块的至少一部分的流动管腔。该流动管腔可减少跨凝块的压力梯度,从而使得其更容易分离和移除。多孔内部通道130可以是管状形状,并且在膨胀时具有可定制的直径,以便降低再灌注损伤的风险。通过管腔的该受约束的血流确保在流动恢复后立即施加到血管的压力低于正常值,从而降低了血管床中出血的风险。随后可通过移除装置和捕集的凝块来恢复完全灌注。
外部保持架构件210可为形成可膨胀主体的多个撑条,该可膨胀主体被构造成在从约束护套(诸如微导管)释放时自膨胀至大于内部主体110的径向尺寸的直径,如图3所示。近侧可膨胀主体216可设置在内部主体110的凝块抓持或夹紧节段120周围,并且远侧可膨胀主体217设置在多孔内部通道130周围。在近侧,外部保持架210可具有支撑臂222,该支撑臂在近侧接合部212处接合到轴6并且径向扩张以形成近侧可膨胀主体216。支撑臂222可具有如图所示的锥形轮廓以确保从轴6至凝块接合可膨胀主体的逐渐刚性转变。支撑臂222可被取向成在围绕装置100的纵向轴线8的离散位置处形成闭孔网络,使得在相邻臂之间存在大周向间隙。例如,如图所示,两组臂222可在很大程度上彼此以大约180度沿直径相对,或者三组臂可间隔开120度。
外部保持架210的近侧部分可具有可膨胀主体216,该可膨胀主体具有不完全围绕装置周向的孔,从而提供小于远侧可膨胀主体217的支架水平。凝块的部分可通入孔与近侧可膨胀主体216的支撑臂222之间的间隙中,使得它们由凝块夹紧结构120接合。在近侧可膨胀主体216中具有非完全周向的孔可导致较低的表面接触面积和径向力,这允许凝块更容易地突出到装置的该节段中的间隙中。当装置撤回到外部导管中时,凝块夹紧结构120可保持对凝块的牢固抓持,但不干扰来自外部保持架210的臂222的支架的撞击。支撑臂222还可具有弯曲部或冠部,这些弯曲部或冠部将远离凝块夹紧元件或至少不在与凝块夹紧元件相同的方向上偏移运动,使得当装置的近侧部分被外部导管部分地约束时,支撑臂不剪切凝块的部分。
一个或多个近侧可膨胀主体216可通过联接撑条233连接到远侧可膨胀主体217的最近侧主体。在一个示例中,这些联接撑条233可以为平行于装置的中心纵向轴线8延伸的大致直的撑条。在其他示例中,这些联接撑条233可具有被构造在一个或多个孔中的多个撑条,或者可以包括弯曲或螺旋臂。相邻可膨胀主体216、217之间的区域可形成入口214,凝块或凝块的部分可穿过所述入口并进入细长内部主体110和外部保持架210之间的接收空间9。
外部保持架210的最远侧部分可具有锥形端部218,该锥形端部以基本上锥形的轮廓径向向下滑动到远侧接合部213。撑条在锥形端部218处的渐缩和会聚减小了撑条之间的开口的孔径以形成碎片捕集区。这些撑条可以是经由连接撑条234连接到远侧可膨胀主体217的最远侧的末端冠状撑条237,如图3所示。端部冠部237可凸出鼓胀或扩张,使得外部保持架210的端部对使用它的血管而言无创伤。形成鼓胀或扩张的撑条可能不与外部保持架的相邻部分的那些平行,从而形成接头或铰链,锥形端部218可通过该接头或铰链围绕远侧可膨胀主体217弯曲或挠曲。接合部213可为纤维的撑条的扭曲或盘绕集合,其可具有或被赋予射线不可透特性以在手术期间标记装置100的终端。
远侧可膨胀主体217可继而通过一个或多个连接臂234连接,这些连接臂可从近侧接合部239延伸到远侧接合部240,如图4中的外部保持架210的侧视图中所见。连接臂234可以是大致直的并且平行于装置100的纵向轴线8延伸。在其他情况下,这些连接臂可以为构造在一个或多个孔中的多个撑条,或者可具有弯曲或螺旋轮廓。远侧可膨胀主体217之间的区域可限定入口214,凝块可穿过该入口并进入接收空间9。远侧可膨胀构件217之间的连接臂234可与近侧可膨胀主体216和远侧可膨胀主体217之间的联接撑条233基本上对齐,以在弯曲期间与主体的中性轴对齐。
外部保持架210的近侧可膨胀主体216和远侧可膨胀主体217可具有一系列互连的撑条以形成闭孔,其中某些撑条诸如冠部撑条232终止于冠部或远侧顶点236,其中没有远侧连接元件连接到任何相邻的闭孔,并且其他主体撑条诸如242终止于主体接合点244。远侧顶点236可从装置100的纵向轴线8偏移并且可在膨胀时靠近由外部保持架210限定的圆柱形平面。在远侧顶点236处接合的冠部撑条232可大体弯曲,以便使顶点之间的偏移和间距最大化,从而实现凝块支架与装置灵活性之间的期望的平衡。使自由顶点236在一些接合部处不具有远侧连接可为装置提供更大的弯曲灵活性。这是因为,除了形成每个孔的撑条的弯曲之外,顶点本身可弯曲以适应脉管系统中的弯曲并且具有对凝块力作出反应的一些能力。
当微导管在装置部署期间回缩时,外部保持架210可膨胀并接触血管壁。当内部细长主体110和夹紧节段120的任何螺旋部分在血管中松脱时,该接触为装置100提供稳定性并且使扭转最小化。这有利于装置100在栓塞或凝块中的均匀部署和膨胀。
外部保持架210的膨胀可在膨胀期间导致凝块的压缩和/或位移,这取决于由撑条提供的支架支撑的水平。当可膨胀主体提供高水平的支架时,凝块可被压缩。另选地,当可膨胀主体提供逃脱路径或开口时,膨胀主体将朝向开口推压凝块。凝块本身可具有许多自由度并且可在多种不同的方向上移动。通过提供长度与闭塞凝块的长度基本上一样长或更长的外部保持架210,除去了凝块可用的许多运动自由度。入口开口214设置在外部保持架210中以引导凝块可用的主要运动自由度,因此外部保持架的膨胀推压凝块进入接收空间9中。这允许在不过度压缩的情况下取回凝块。这是有利的,因为凝块的压缩可导致其脱水,这继而增加了凝块的摩擦特性和刚度,这使得凝块更难以从血管脱离和移除。如果随着外部保持架朝向血管壁向外扩张,凝块很容易通过外部保持架的近侧部分中的孔或间隙向内迁移,则可避免这种压缩。
使用自膨胀主体的另一个优点是,由于目标凝块的体积特性和刚度,当跨凝块部署时,阻力可导致装置100初始仅膨胀至其自由膨胀直径的一部分。这赋予外部保持架210在回缩的同时进一步膨胀到更大直径的能力,使得当外部保持架回缩到逐渐变大且更近侧的血管中时,该外部保持架可保持与血管壁接触。
图5示出了来自图2的装置100的内部细长主体110。凝块接合夹紧节段120和多孔内部通道130可由形状记忆材料诸如镍钛诺的单个条带或管一体地形成,然后将其激光切割以形成撑条图案。另选地,它们可独立地形成并随后附接以允许两个构件呈现不同的形状。内部主体110还可具有在夹紧部分120的近侧端部121和其上安装有装置的细长轴6之间的近侧接头或转变部。
细长内部主体110可被构造成膨胀至直径比其旨在用于其中的最小血管的直径更小的直径。当内部主体为非锥形时,该直径通常小于膨胀的外部保持架直径的50%,并且在一些情况下可低至外部保持架直径的20%或更小。这允许内部主体的部分可由非常小体积的材料构造,因为其仅需要膨胀到外部保持架的直径的一部分,并且因此在塌缩状态和膨胀状态下均可为高度灵活的。这种灵活性可有利地允许内部主体在一个方向上被凝块的一部分移位,并且在另一个方向上被凝块的另一部分移位。
凝块夹紧节段120可以是装置100的内部细长主体110的更近侧区域中的接合元件。夹紧节段120旨在通过在凝块和血管壁之间膨胀以使得在显著的表面区域上方与凝块接合并且在凝块的最小压缩的情况下进行的方式来有利于凝块取出。整体凝块压缩被最小化,因为节段可被构造成具有高压缩环与深撑条嵌入,其中散布有最小凝块压缩和低径向力的区域。凝块的一部分可突出到低压缩区域中并且被夹紧在导管的末端与装置的撑条之间。通过将微导管或外部导管在夹紧节段120的近侧端部121上方向前推进,直到凝块的一部分被压缩在导管的末端与夹紧节段的冠部或撑条之间,来实现夹紧。这种夹紧有利于移除凝块,因为其增加了装置对凝块(具体地讲富含纤维蛋白的凝块)的抓持。该夹紧还可通过在脱离过程期间将与血管壁分离来拉长凝块,从而减小脱离力。在将凝块回缩到微导管或外部导管期间,可通过控制凝块的近侧端部并防止凝块阻塞侧分支血管来改善凝块的保留。
在凝块夹紧节段120的远侧,内部通道130可为大致管状、平面或一些其他形状,其中腔结构的直径小于外部保持架210的周围部分的直径。在一个示例中,远侧内部通道130可从凝块夹紧节段的远侧端部122转变以形成圆筒形状,使得该节段的径向尺寸小于或大于处于所示膨胀构型的近侧夹紧节段120的径向尺寸。这允许跨非常长的凝块形成流动通道,而不会过度压缩凝块或使内部通道130与血管壁接合。内部通道130可以与夹紧节段一体地形成,或者可以单独地形成并且通过衬圈或其他机械接头连接。在其他情况下,内部通道130可具有非圆柱形横截面,直径可为不均匀的,并且可具有定制的撑条图案以提供具有不同径向力或灵活性的区域。
在另一个示例中,该形状可以是基本上管状的,并且具有如图5所示的以一定间隔远离并朝向装置的轴线8会聚的多个撑条,撑条形成孔132被构造成在其膨胀状态下接合凝块并限定通过凝块的流动管腔。当膨胀时,孔132可互穿凝块并提供附加的抓持以有助于凝块的初始分离,同时还支撑通过凝块的流动管腔以防止碎片释放。
内部通道130的远侧端部136可转变为碎片保护结构14或利用拴系件或轴与该碎片保护结构连接。碎片保护结构14可以为多个撑条,这些撑条以体积图案、编织或缠结网过滤器、或篮状或锥形形状构造,以阻止或收集来自装置的朝远侧行进的碎片。结构14也可以是球形或类似形状的纤维束,并且在膨胀状态下,碎片保护结构的至少一部分具有大于流动通道130和夹紧节段120的径向尺寸,并且在尺寸上可与目标血管的直径类似。碎片保护元件14的远侧端部可具有射线不可透的线圈元件16,该射线不可透的线圈元件可在处理期间从用于内部通道130的构造中的相同管材激光切割下来。
内部细长主体110和外部保持架210可在轴6处朝近侧并且也可在组装期间朝远侧接合,以便在使用期间使构件之间的张力最小化。凝块夹紧节段120、内部通道130或上述两者的撑条可伸长和缩短,使得当装载在微导管中时以及当在目标部位处自由膨胀时,内部主体的长度和外部保持架的长度基本上相同。沿线圈元件16的内部主体和外部保持架的闭孔可允许装置通过拉伸来适应较小的长度差,但不向接头施加显著的拉伸力或压缩力。当例如装置在小血管中膨胀、塌缩或部署时,可出现长度差。
图6中示出了图5的内部细长主体110的凝块夹紧节段120的放大和放大视图。另选的环节段145可通过重叠撑条形成,并且在局部顶点处形成中间冠部147。低密度凹槽146的节段可在连续的环节段145之间延伸并由其界定,其中与由环节段145产生的相比,纵向延伸的桥接撑条施加较低水平的支架和减小的径向力。当夹紧部分120膨胀或收缩时,撑条的重叠可允许每个环节段145相对于其相邻环扭转,但其中每个扭转均可抵消下一个,使得在相对于近侧端部121的远侧端部122处的夹紧部分中出现最小总体扭转。最小限度的扭转有助于确保对所夹紧凝块的抓持不会丢失。
撑条145的环之间的低密度凹槽146中的桥接撑条的纵向长度可变化。例如,当在大脑中动脉中使用时,纵向间距可为大约3mm-6mm。该间距允许凝块在撑条之间突出,其中该凝块接合处于膨胀的部署构型的夹紧节段。环节段145和凹槽节段146的总长度和/或数量可针对预期长度和密度进行优化,以便最佳地嵌入凝块中。环节段145之间的桥接撑条144可以是直的并且与装置的轴线8平行,以获得更好的可推送性,从而确保装置可通过曲折的解剖结构递送。
夹紧节段120中的撑条还可在沿其长度的各个轴向位置处具有一个或多个弯曲148。由撑条144中的这些弯曲148形成的“狗腿”型形状可围绕节段的周向或径向方向重复以形成孔。由弯曲部148形成的角度或撑条144的长度在适当位置变化,或者图案中的不同撑条也可具有不同的宽度,使得各种节段可具有更高的膨胀力,以改善在膨胀的部署构型中与凝块的接合。该结构可通过激光切割镍钛诺原料并热定形形状来制备,使得其在膨胀时呈现期望的轮廓。
图7中示出了内部细长主体110的另一个示例,该内部细长主体具有远侧内部通道130以及被构造为凝块接合夹紧节段120的近侧接合元件。当完全膨胀时,夹紧节段120可具有与内部通道130相同或不同的径向尺寸,但是两个结构可一体地形成,使得在夹紧节段的远侧端部122处不存在显著的刚度转变。碎片保护元件14可形成或以其他方式附接到内部通道130的远侧端部136,并且被构造成在装置100跨凝块部署时转变到大于凝块夹紧节段120和内部通道两者的膨胀径向尺寸。
与图5中相比,夹紧节段120可沿其长度的部分具有更密集地间隔开的环节段145。如所讨论的,该节段120可具有撑条环145以及低径向力和撑条密度的区域146。当推进微导管或外导管时,使相邻的环节段145在夹紧节段120的某些轴向位置处一起紧密间隔开可增加凝块夹紧构型中的环之间的夹紧的效果。
在回缩期间,可丢失对富含纤维蛋白的凝块的夹紧,或者凝块可包含未完全抓持在近侧夹紧节段120上的富含红细胞的“软”节段。在这些情况下,远侧多孔内部通道130的撑条可提供与凝块的接合,并且通过直径增大的血管、经过弯曲部和分支将凝块取回到微导管或外导管。此外,碎片保护元件14的膨胀的孔和/或撑条以最小的剪切与任何释放的碎片或未抓持的凝块节段接合。
参见图8,示出了另一个内部细长主体110,该内部细长主体具有与上述其他装置类似的一些特征结构。内部细长主体110可朝近侧附接到轴6。该连接可以是衬圈或允许外部保持架210和内部主体之间至少部分相对旋转的一些其他轴向约束。在手术期间,也可在该位置处使用射线不可透标记物(未示出)来标记装置100的可膨胀部分的近侧终止点。
内部主体110可具有近侧凝块接合元件120和更远侧的管状内部通道130。三维网片状结构或篮可由线或纤维形成为碎片保护元件14,该碎片保护元件保持在远侧内部通道130的远侧端部136处和外部保持架210内。线或纤维可无规卷曲和/或扭转以占据结构内的空间,或者它们可成型为特定图案。
凝块接合元件120可具有形成多个相邻节段152的撑条,其中相邻节段的不同形状导致由连续相邻节段产生的径向力不相等。一些撑条可具有弯曲部148(诸如图6所示的那些),使得当凝块接合元件从膨胀的部署构型转变为部分受约束的凝块夹紧构型时,相邻撑条144可压缩凝块。相邻节段152的部分中的撑条可与装置的纵向轴线8成角度重叠,因此它们在定位在脉管系统中的弯曲部中或移动穿过脉管系统中的弯曲部时可相对于彼此在不同方向上滑动。另外,相邻节段152的部分可具有沿着某些平面偏置塌缩或改变轴向或径向方向上的长度的特征。撑条长度的差异确保了由夹紧节段120施加到凝块的径向力变化,以实现对凝块的良好抓持,同时有利于与微导管或外导管相关联的凝块取回。
在图9所示的装置100的另一个示例中,内部细长构件110的凝块夹紧节段120的撑条图案可通过激光切割大致平坦的二维片材并且在热定形之前将所得的平坦图案缠绕在圆柱形芯轴周围来形成。然后,装置的中心线可围绕纵向轴线8形成螺旋或盘旋图案,类似于围绕圆柱体缠绕带的过程。在近侧端部处,凝块夹紧结构120可连接到轴6。在凝块夹紧节段120的远侧端部122处连接的内部通道130也可为平坦图案,具有弯曲或异形的横截面,或者为如其他公开的示例所示的大致管状形状。
当跨凝块部署时,凝块的部分可迁移穿过外部保持架210的可膨胀主体216、217的入口214和孔,或可膨胀主体之间的空间,并进入接收空间9或装置中。在此,凝块可突出到低撑条密度的区域中,并且还突出到凝块夹紧结构120的螺旋盘旋图案的中心管腔中。近侧可膨胀主体216的间隙和下部支架有利于进入凝块夹紧结构120的螺旋。当装置100随后回缩时,当外导管朝远侧前进以使装置从膨胀的部署构型转变为部分受约束的凝块夹紧构型时,该螺旋可改善抓持和分离性能并且有利于凝块夹紧动作。如果装置100的凝块夹紧结构120由两个或更多个螺旋盘旋部件构造,则此类效果也可增加。
螺旋盘旋形状还可允许凝块夹紧结构120的部分在张力下伸长,从而在分离期间拉伸凝块的部分。凝块的近侧端部可被夹紧和约束在凝块夹紧结构120上,同时凝块的远侧端部可定位在内部通道130上以嵌入和打开流动通道。如果凝块的远侧端部保持粘附在血管中,则内部通道130和外部保持架210可保持静止,同时凝块夹紧节段120在一些节段中膨胀并且在其他节段中响应于凝块力而收缩。该动作可有助于在手术期间从血管壁剥离凝块并减小分离力。
碎片保护元件14可通过拴系件或轴134连接到内部通道130的远侧端部136。保护元件14可以是体积图案,该体积图案膨胀到比沿细长内部主体110的任何点处的径向尺寸更大的径向尺寸。元件的形状可以是如图所示的锥形篮或网片元件或纤维束,其占据足够空间以阻止凝块或血栓碎片朝远侧通过。
当元件处于膨胀的部署构型和凝块夹紧构型时,撑条网络和凝块夹紧元件120的相邻节段152的确切形状和构型将确定在沿结构的不同轴向位置处施加的径向力。力可例如在大致正弦波形图案124中变化,其中局部变化的峰126确定该位置处的力的振幅128。根据沿凝块接合元件120的轴向位置而变化的径向力的样本曲线图在图10中示出,以说明该概念。振幅128可在图案化距离处重复,使得其沿接合元件120的长度相对相等,或者其可沿长度减小,使得力在远侧端部122处较低并且在近侧端部121处较高,其中夹紧的初始抓持允许凝块脱离接合。该曲线图示出了例如嵌入凝块中的环节段145可如何具有比环之间的低密度凹槽节段146更高的径向力。可通过使撑条相对于血管的纵向轴线的角度最大化来增大径向力增加区域的有效性,这可允许环节段145抓持凝块而不是滑过凝块。具有这些不同径向力的区允许装置100在峰值126的区域中保持对凝块的抓持,同时在峰值之间对凝块施加少得多的压缩,这有助于使回缩凝块所需的总力最小化。
当推进微导管或外部导管以增加对凝块的夹紧时,使用者可感觉到作为阻力的夹紧并停止推进导管,或者另选地可在接合元件120的近侧端部121和外部保持架210的更近侧可膨胀主体216上方推进固定距离。外部保持架210的近侧可扩张主体216中的较低水平的支架允许保持接合元件120和导管之间的相对张力,使得接合元件和导管之间的夹紧在凝块回缩期间不会劣化。
图11a至图11e以及图12和图13的流程图示出了本发明所公开的设计的使用方法。将导丝11和微导管13插入和引导通过脉管系统40中,并且使用常规已知的技术将其推进穿过阻塞性凝块20。当将微导管13定位在闭塞凝块40的远侧时,可将导丝11从血管40移除,以允许凝块取回装置100被推进穿过微导管。装置100以塌缩构型推进,直到装置的远侧末端到达微导管的远侧端部。可回缩微导管13,同时使用轴6保持装置100的位置,以将凝块取回装置部署在凝块20上,优选地以使得装置的远侧端部定位在凝块的远侧的方式部署,如图11b所示。装置100膨胀,使得外部保持架210可与闭塞凝块20接合并允许凝块径向向内通过。凝块夹紧节段120和多孔内部通道130可膨胀以嵌入凝块并提供流动通道以通过受控方式恢复血流。在已经通过内部通道130恢复的受控流动稳定时,如果需要,可以允许装置100在凝块20内保留一段时间。
图11c示出了在取回到微导管13期间与装置接合的凝块20。导管的推进致使衬圈12将凝块20压缩在环节段145的冠部147与低密度凹槽节段146的桥接撑条144之间,如图11d所示。根据条件,夹紧接合也可受到中间导管或其他外部导管的影响。凝块可部分地位于装置的入口开口214中,并且还部分地位于由内部主体110与外部保持架210之间的区域限定的接收空间9中。凝块碎片可被捕集在外部保持架210的远侧闭合锥形端部218和碎片保护元件14中,以防止碎片在血流中释放。在该过程期间可使用血流闭塞、抽吸和其他标准技术。
装置和微导管之间的相对张力可由使用者在分离和回缩期间保持,以确保对凝块的夹紧被保持,如图11e所示。虽然使用微导管或中间导管夹紧凝块被描述为在与本发明一起使用时提供附加有益效果,但本文所述的所有实施方案也可用于分离和取回凝块,而无需使用导管夹紧(如果需要)。装置100的外部保持架210的远侧闭合端部和膨胀的碎片保护元件14防止捕集的凝块碎片在血流中释放。
图12和图13是用此类装置执行血栓切除手术的方法步骤的图。方法步骤可通过示例性装置中的任一种或通过本文所述和本领域普通技术人员已知的合适替代形式来实现。该方法可具有所述步骤中的一些或全部,并且在许多情况下,步骤可以与下文所公开的顺序不同的顺序执行。
参见图12中概述的方法1200,步骤1210可涉及提供外部导管,该外部导管可在其远侧端部处具有管状主体和衬圈。根据情况,外部导管可以是微导管、中间导管或本领域技术人员已知的任何其他合适的护套,其直径适于实现对装置的夹紧,如前所述。
步骤1220可提供具有塌缩递送构型、膨胀的部署构型和可膨胀元件的凝块取回装置。近侧轴可用于在手术期间操纵装置。可膨胀元件可具有内部主体和外部主体,该外部主体可膨胀到比内部主体更大的径向程度。内部主体可具有近侧夹紧元件和远侧流动通道元件。外部主体可具有围绕夹紧元件设置的非周向的第一支撑架节段和围绕流动通道元件并连接在第一支架节段的远侧的完全周向的第二支架节段。非周向的第一支架节段可允许凝块附近的部分可容易地向内穿过外部主体中的间隙以与内部主体的近侧夹紧元件接合。
步骤1230可涉及通过微导管将处于塌缩递送构型的凝块取回装置递送到闭塞血管。在颅内闭塞的情况下,多种进入路径是可能的,包括直接插入颈动脉中、肱动脉入路或股动脉进入。一旦使用常规且熟知的技术获得进入动脉系统的通路,导向导管或长护套(未作为图11a至图11e的一部分示出)通常就尽可能靠近闭塞凝块放置。例如,在大脑中动脉闭塞的情况下,导向导管可放置在颈动脉虹吸部的近侧的颈内动脉中。然后可借助或不借助导丝将微导管推进穿过凝块。一旦将微导管末端推进穿过凝块并推进到凝块的远侧,就可移除导丝(如果使用的话),并且将凝块取回装置推进通过微导管,直到其到达远侧端部。
然后在步骤1240中,微导管可回缩,从而允许凝块取回装置在凝块的任一侧内膨胀。该步骤还可涉及外部主体的支架区域在凝块内膨胀以施加压缩力,从而推压凝块流过入口孔并进入内部主体和外部主体之间的空间中。当外部主体部署到膨胀的部署构型时,凝块的至少一部分可径向地穿过非周向第一支架节段中的周向间隙并与夹紧元件的至少一部分接触。由于外部主体中的较大孔开口以及非周向第一支架节段中的间隙,凝块压缩可被控制并最小化。使凝块上的压缩最小化减小了径向向外施加到血管壁的力,这继而减小了回缩凝块时要克服的摩擦力。
继续参见图13,方法1300可具有步骤1310,该步骤抑制凝块迁移到流动通道元件中,以在膨胀的部署构型中允许血液流过流动通道元件。由于该装置可被构造成具有两部分长内部主体,因此在装置部署时,流动通道元件的膨胀可形成穿过凝块的流动通道,从而恢复到凝块的远侧的血管床的流动并减小跨凝块的压力梯度。这种压力梯度的减小减小了使凝块从血管壁脱离并朝近侧回缩凝块所需的力。另外,流动通道允许装置在撤回之前安全地留在适当的位置并持续一段停留时间。停留允许远侧血管床轻轻地灌注新鲜含氧血液,而不是暴露于压力和流动的突然瞬态尖峰,如凝块被立即移除或装置压缩凝块太多以致在部署时形成非常大的流动通道的情况。
在牢牢地保持凝块取回装置的位置的同时,步骤1320可涉及沿细长轴推进外部导管,使得外部导管的衬圈与可膨胀元件接合,以利用夹紧元件以压缩形式夹紧凝块的至少一部分。这可借助于通过外部导管和/或导向导管的抽吸来完成,以有助于维持对凝块的牢固抓持并避免碎片丢失。然而,本发明所公开的设计牢固地抓持凝块并且将凝块安全地容纳在接收空间内,具有远侧碎片保护元件和支架区域的附加有益效果。保护元件可与内部构件的远侧端部间隔开,因此其被最佳地定位成捕集在回缩期间从凝块释放的任何碎片。
在步骤1330中,将移除外部导管和凝块取回装置一致地从血管中撤回,同时保持外部导管的衬圈与可膨胀元件之间的接合。连同抽吸一起,这种接合在其通过弯曲部和连续较大的血管直径撤回时保持对凝块的牢固夹紧抓持。
在步骤1340中,可从患者体内移除凝块取回装置和夹紧的凝块。如果需要,可将装置在盐水中冲洗并轻轻清洁,然后重新装载到微导管中。然后可将其重新引入脉管系统中以重新部署在附加的闭塞凝块节段中,或者在需要进一步通过以进行完全再通时。
本发明不必限于所描述的示例,这些示例的构型和细节可变化。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/所述”包括复数指代。
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”可是指列举值的值±20%的范围,例如“约90%”可是指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。在不脱离本发明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。类似地,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。为清楚和简洁起见,并未列出所有可能的组合,并且此类变型形式对于本领域技术人员而言通常是显而易见的,并且旨在落入以下权利要求书的范围内。
Claims (20)
1.一种用于从血管中移除凝块的装置,包括:
形成细长内部主体的撑条框架,所述细长内部主体具有近侧端部、远侧端部和纵向轴线,所述细长内部主体包括:
凝块夹紧结构,所述凝块夹紧结构包括受约束的递送构型、膨胀的凝块接合部署构型和至少部分受约束的凝块夹紧构型,所述凝块夹紧结构被构造成在从所述部署构型移动到所述凝块夹紧构型时夹紧所述凝块;以及
多孔内部通道,所述多孔内部通道连接到所述凝块夹紧结构的远侧端部并且包括管状主体,所述管状主体被构造成形成穿过所述凝块的管腔并且在部署时恢复流动;以及
形成可膨胀管状外部保持架的撑条框架,所述外部保持架能够膨胀到大于所述细长内部主体的径向程度,以限定所述外部保持架和所述细长内部主体之间的接收空间,所述外部保持架包括:
第一支架节段,所述第一支架节段包括一个或多个近侧可膨胀主体,所述一个或多个近侧可膨胀主体包括多个非周向闭孔,所述凝块夹紧结构在所述第一支架节段内部延伸;以及
第二支架节段,所述第二支架节段包括一个或多个远侧可膨胀主体,所述一个或多个远侧可膨胀主体包括位于所述第一支架节段的远侧的多个完全周向闭孔,所述多孔内部通道在所述第二支架节段内部延伸。
2.根据权利要求1所述的装置,所述多孔内部通道的所述撑条限定内部主体闭孔,其中所述外部保持架的所述第一支架节段和所述第二支架节段的所述闭孔大于所述内部主体闭孔。
3.根据权利要求1所述的装置,所述多孔内部通道的至少一部分被构造成在能够径向膨胀成所述部署构型时互穿所述凝块。
4.根据权利要求3所述的装置,所述第一支架节段的所述非周向闭孔包括一个或多个支撑臂,所述支撑臂围绕所述纵向轴线间隔开,使得相邻臂之间存在大周向间隙。
5.根据权利要求1所述的装置,所述第一支架节段包括围绕所述纵向轴线基本上沿直径相对的两个支撑臂。
6.根据权利要求1所述的装置,所述第一支架节段和所述第二支架节段的每个可膨胀主体包括不连接至相邻闭孔的至少一个远侧顶点。
7.根据权利要求1所述的装置,其中所述凝块夹紧结构包括多个相邻节段,并且其中所述节段被构造成使得由至少两个相邻节段施加的径向力彼此不同。
8. 根据权利要求1所述的装置,其中所述凝块夹紧结构包括:
多个凝块接收孔,以及
包括在冠部之间延伸的撑条的孔,所述撑条被构造成在所述凝块夹紧结构从所述膨胀的部署构型移动到所述至少部分受约束的凝块夹紧构型时夹紧位于所述孔中的凝块。
9.根据权利要求1所述的装置,所述凝块夹紧构型通过以下方式实现:在所述第一支架节段和所述凝块夹紧结构上方推进导管,直到所述凝块的至少一部分被压缩在所述导管的末端与所述凝块夹紧结构的所述撑条的至少一部分之间。
10.根据权利要求1所述的装置,所述第一支架节段和所述第二支架节段的相邻的所述可膨胀主体以铰接方式彼此连接。
11.一种用于从血管移除闭塞凝块的凝块取回装置,包括:
内部细长主体,所述内部细长主体包括:
近侧凝块接合元件,所述近侧凝块接合元件包括受约束的递送构型、膨胀的凝块接合部署构型和至少部分受约束的凝块夹紧构型;以及
远侧管状内部通道,所述远侧管状内部通道连接到所述凝块接合元件的远侧端部并且包括受约束的递送构型和膨胀的部署构型,所述内部通道被构造成在所述膨胀的部署构型中允许血液流过所述内部通道;以及
多孔外部主体,所述多孔外部主体包括非周向近侧节段和可枢转地连接到所述近侧节段的完全周向远侧节段,所述外部主体能够膨胀到大于所述内部细长主体的径向程度;
所述凝块接合元件还包括撑条框架,所述撑条框架被构造成在膨胀到所述部署构型时对所述凝块施加向外径向力,所述向外力沿所述凝块接合元件的长度以大致正弦波形图案变化。
12.根据权利要求11所述的装置,所述波形图案的振幅沿所述凝块接合元件的所述长度大致相等。
13.根据权利要求11所述的装置,所述波形图案的所述振幅沿所述凝块接合元件的所述长度减小,在所述凝块接合元件的近侧端部处较高,并且在所述凝块接合元件的所述远侧端部处较低。
14.根据权利要求11所述的装置,所述装置具有延伸穿过所述凝块接合元件和所述管状内部通道的纵向轴线(8),所述凝块接合元件的所述撑条形成围绕所述纵向轴线以螺旋构型设置的平面图案。
15.根据权利要求11所述的装置,所述凝块接合元件还包括多个相邻节段,由至少两个相邻节段施加的所述径向力彼此不同。
16.根据权利要求11所述的装置,所述凝块接合元件的相邻撑条包括至少一个弯曲部,所述弯曲部被构造成使得当所述凝块接合元件移动到所述凝块夹紧构型时,相邻撑条压缩所述凝块。
17.根据权利要求11所述的装置,所述外部主体的所述近侧节段和所述远侧节段各自包括一个或多个可膨胀主体,所述可膨胀主体包括呈闭孔形式的多个撑条。
18.根据权利要求17所述的装置,所述近侧节段和所述远侧节段的每个可膨胀主体包括不连接到相邻闭孔的至少一个远侧顶点。
19.一种治疗具有阻塞血管的凝块的患者的方法,所述方法包括以下步骤:
提供外部导管,所述外部导管包括管状主体和位于所述外部导管的远侧端部处的衬圈;
提供凝块取回装置,所述凝块取回装置包括塌缩的递送构型、膨胀的部署构型、细长轴以及位于所述细长轴的远侧的可膨胀元件,所述可膨胀元件包括:
内部主体,所述内部主体包括近侧夹紧元件和连接在所述夹紧元件的远侧的流动通道元件;以及
外部主体,所述外部主体沿纵向轴线延伸,所述外部主体包括非周向的第一支架节段和完全周向的第二支架节段,所述完全周向的第二支架节段可枢转地连接在所述第一支架节段的远侧;
通过微导管将处于所述塌缩构型的所述凝块取回装置递送到阻塞的血管;
部署所述凝块取回装置,使得所述凝块的至少一部分径向穿过所述非周向的第一支架节段中的周向间隙并与所述夹紧元件的至少一部分接触;
在牢牢地保持所述凝块取回装置的位置的同时,沿所述细长轴推进所述外部导管,使得所述外部导管的所述衬圈与所述可膨胀元件接合,以利用所述夹紧元件以压缩形式夹紧所述凝块的至少一部分;
将所述外部导管和所述凝块取回装置一致地从所述血管撤回,同时保持所述衬圈与所述可膨胀元件之间的所述接合;以及
将所述凝块取回装置和夹紧的凝块从患者移除。
20.根据权利要求19所述的方法,还包括抑制所述凝块迁移到所述流动通道元件中,以在所述膨胀的部署构型中允许血液流过所述流动通道元件。
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