CN114246639A - 旋转框架血栓切除装置 - Google Patents
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Abstract
本发明题为“旋转框架血栓切除装置”。本发明公开了一种用于从血管中移除凝块的装置,该装置可具有双层,其中内部可膨胀主体在外部可膨胀主体内延伸。该装置可具有塌缩递送构型、膨胀部署构型和凝块夹紧构型。内部主体和外部主体可为由撑条网络形成的多个单元。当装置部署在凝块内时,单元的开口对准,其中来自膨胀主体的径向力推压凝块的部分穿过开口。内部主体和外部主体可被构造成能够相对于彼此选择性地平移,使得当平移使装置转变为凝块夹紧构型时,凝块在单元开口中的部分可被压缩和夹持。可保持平移以在从患者体内取回凝块时夹紧凝块。
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,这可导致许多并发症。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在回缩期间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各种血栓切除情况中的所有凝块类型。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,则它们可能迁移,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。
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。每次撤回凝块取回装置时,对目标部位的进入都会丢失。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。该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。
在此环境下寻求手术效率时,具有多个主体的装置通常是优选的。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塌缩以重新套入外部导管内。由于这些装置被设计成使得通常需要凝块迁移穿过外部构件,因此外部构件可在凝块的周边区域上具有不太牢固的夹持。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。
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
本发明所公开的凝块取回装置的设计通过提供双层装置来解决这些问题,其中内部构件和外部构件一致地工作以沿着装置的全长来捕获整个凝块。该设计的特征可在于部署构型,其中内部构件和外部构件均具有大的单元开口,该单元开口对准以允许所施加的径向力在装置膨胀时使凝块迁移穿过开口。构件中的一个构件可随后相对于另一个构件平移,使得对准的单元开口闭合,从而将凝块压缩地夹紧在内部构件和外部构件的单元的相对边缘之间。该动作增加了在取回的所有阶段期间装置对凝块的夹持的安全性,从而允许更安全且更有效的流动恢复。
该装置在被约束在外部导管内时可具有塌缩递送构型,并且在部署在目标部位处时可具有膨胀凝块接合部署构型。该装置可具有用于独立操纵的细长轴。该轴可连接到撑条框架,从而形成从轴朝远侧延伸的可膨胀构件。细长轴的特征可在于第一轴和能够相对于第一轴平移和/或旋转的第二轴。这些轴可用于在手术期间由使用者控制和激活可膨胀构件的功能。
可膨胀构件可具有双层构造,该双层构造具有连接到第二轴的内部主体和连接到第一轴的外部主体。这些主体可包封基本上管状的内部管腔和延伸穿过其的纵向轴线。内部主体和外部主体的特性可彼此独立地进行定制。外部主体可与内部主体同轴或可径向偏移。内部主体可基本上布置在外部主体的管腔内。
内部主体可具有多个单元并且能够围绕纵向轴线相对于外部主体平移。外部主体还可具有多个闭合单元并且具有大于处于膨胀部署构型的内部主体的径向尺寸,并且可被构造成与目标血管的壁并置并且支撑目标血管的壁。外部主体也能够围绕纵向轴线相对于内部主体平移。平移可使装置在膨胀部署构型和凝块夹紧构型之间转变。
可膨胀构件的内部主体和外部主体的单元的尺寸可大致相等,或者它们的尺寸可不同,使得单元的边界之间存在一些重叠。当在目标部位处跨凝块部署到膨胀构型时,内部主体和外部主体的单元的撑条可通过施加径向力以抵靠血管壁压缩凝块来与凝块接合并嵌入凝块中。内部主体和外部主体的单元可对准,使得该压缩推压凝块的至少部分径向向内迁移穿过单元并朝向内部管状管腔。由外部构件施加的径向力可大于或小于由内部构件施加的径向力。在其他示例中,内部构件和外部构件的径向力可大致相等。
当使用者诸如使用第一轴和第二轴使内部主体或外部主体相对于彼此平移时,内部主体的单元和外部主体的单元可偏移。平移可为沿纵向轴线呈线性的、围绕轴线的旋转或这些的组合。当相对运动使装置从膨胀部署构型转变为凝块夹紧构型时,平移可在主体的偏移单元的撑条之间压缩和夹紧凝块。单元中的这种夹紧约束凝块的部分,使得在装置从目标部位回缩时牢固地夹持凝块。当凝块被撤回时,可保持内部主体与外部主体之间的相对平移,使得装置保持在凝块夹紧构型中并且不失去夹持。
可通过装置的第一轴和第二轴来致动用于凝块夹紧构型的内部主体和外部主体的平移。例如,第一轴可具有细长管状主体,该细长管状主体具有内部管腔和靠近其远侧端部的穿过壁厚的狭槽。第二轴可为设置在第一轴的管腔内的圆柱形构件,因此两个轴能够相对于彼此移动。分度销可从第二轴的外表面径向向外延伸,使得其被构造成在第一轴中的狭槽的界限内接合和移动。分度销和狭槽的尺寸可被设定成使得销(以及因此内轴和内部主体)的周向旋转和/或轴向运动被引导穿过狭槽的长度。狭槽的取向例如可平行于纵向轴线或可被取向成使得狭槽的轴线与装置的纵向轴线形成角度。如果使用者随后沿轴的轴线推动或牵拉内轴的细长主体,则分度销可沿狭槽轴线发生运动,从而允许内轴和内部主体相对于外轴和外部主体旋转和平移。这种运动可使内部主体和外部主体的单元偏移以夹紧并牢固地夹持凝块。该过程也可反向,以使装置从凝块夹紧构型转变回膨胀部署构型。
在另一个示例中,内部主体可具有接合到第二轴的内部支撑臂,并且外部主体可具有接合到第一轴的外部支撑臂。这些支撑臂可以一定角度形成以围绕纵向轴线扭转。然后,当在装置上推进外部导管或进入导管时,内部支撑臂或外部支撑臂上的切向力可影响装置的内部主体和/或外部主体相对于彼此的扭转。这种相对扭转可导致夹紧并牢固地夹持凝块所需的平移。
在另一个示例中,用于治疗身体血管中的凝块或闭塞物的装置可具有围绕纵向轴线构造的管状内部管腔。该装置可具有内部主体,该内部主体具有约束递送构型、膨胀部署构型以及形成多孔内部凝块支架节段的多个撑条。外部主体可围绕内部主体设置并且共用约束递送构型和膨胀部署构型。外部主体也可为多孔的,其中互连的多个撑条形成外部凝块支架节段。细长轴可在内部主体和外部主体的近侧延伸,从而允许使用者控制和操纵装置。
内部主体和外部主体的支架节段的撑条可形成开放单元或闭合单元的环。单元可具有大致相等的尺寸或可具有不同的尺寸。当装置从约束递送构型递送时,内部主体的单元可与外部主体的单元对准,以在目标部位处膨胀到部署构型。支架撑条的膨胀可对凝块或闭塞物施加向外的径向力,从而嵌入支架节段的撑条并促使凝块的部分穿过对准的单元中的开口并朝向内部管状管腔径向向内迁移和突出。
内部主体和外部主体能够围绕纵向轴线相对于彼此平移。可由使用者通过操纵细长轴来激活该平移。轴可具有附接到外部主体的第一轴,该第一轴包封连接到内部主体的第二轴,使得第一轴和第二轴能够相对于彼此平移。这样,当使用者在保持外部第一轴稳定的同时平移和/或旋转内部第二轴时,内部主体相对于外部主体平移和/或旋转。类似地,当使用者在保持第二轴的位置的同时平移和/或旋转第一轴时,外部主体相对于内部主体平移和/或旋转。根据第一轴和第二轴的构造,相对平移可为线性运动、围绕纵向轴线的旋转或两者的组合。主体的平移可导致凝块突出穿过的内部主体单元和外部主体单元偏移,从而在相应单元的相对边缘之间压缩凝块。
一种利用所公开的装置治疗具有阻塞血管的凝块的患者的方法可具有跨凝块递送凝块取回装置的步骤。该装置可具有塌缩递送构型和膨胀部署构型、用于控制装置的细长轴、以及位于细长轴远侧的可膨胀元件。塌缩递送构型允许将凝块取回装置递送穿过具有相对小的孔的导管诸如微导管,之后在导管被撤回时在目标部位处膨胀。
可膨胀元件可具有包括多个单元的内部主体和包括多个单元的外部主体,并且在部署状态下能够膨胀到比内部主体更大的径向尺寸。内部主体和外部主体可被构造成围绕纵向轴线在部署构型和凝块夹紧构型之间相对于彼此平移。
细长轴可具有连接到外部主体的第一轴和连接到内部主体的第二轴。可通过例如将第一轴和第二轴构造成能够相对于彼此选择性地移动来实现外部主体和内部主体的平移。该方法于是可包括利用第一轴选择性地对外部主体施加相对于内部主体的运动或利用第二轴选择性地对内部主体施加相对于外部主体的运动的步骤。运动可为线性的、曲线的、旋转的、这些的组合、或另一种合适的轮廓。
另一个步骤可涉及限制第一轴和第二轴相对于彼此的平移的范围。限制功能可有助于防止使用者将内部主体和外部主体平移超过设计限制,其中主体的单元的增大偏移可松开对凝块的夹持或剪切凝块。可通过使用狭槽、套管、凸轮/从动件或其他合适的布置结构作为物理止动件来实现限制,以阻止轴的进一步平移。
另外的步骤可涉及将凝块取回装置部署到膨胀部署构型,使得内部主体的单元与外部主体的单元对准并暴露。当膨胀时,内部主体和外部主体均可对凝块施加向外径向力,从而将凝块固定在血管壁上并迫使凝块的至少一部分径向向内穿过内部主体和外部主体的单元中的开口。当凝块的部分已突出穿过单元开口时,使用者可使内部主体或外部主体中的一者相对于另一者平移,从而将装置从膨胀部署构型转变成将凝块夹紧在内部主体单元和外部主体单元的撑条之间。夹紧的凝块保持牢固地压缩在单元之间,从而允许从血管中撤回凝块取回装置,同时通过维持内部主体与外部主体之间的相对平移来保持夹持。然后可独立地或通过将装置和凝块撤回到外部导管或中间导管中,从患者体内取回凝块取回装置和夹紧的凝块。
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,可使用凝块取回装置进行附加疏通。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,在这些附图中,类似的参考标号指示功能相似或相同的元件。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另一个凝块取回装置的侧视图;
图3示出了根据本发明的各方面的凝块取回装置的另一个示例;
图4是根据本发明的各方面的使用第一轴和第二轴的用于凝块夹紧取向的可能激活机构的示例;
图5示出了根据本发明的各方面的处于膨胀部署构型时内部主体和外部主体的单元平行于凝块取回装置的轴线的对准;
图6示出了根据本发明的各方面的在单元沿装置轴线施加线性平移之后处于凝块夹紧构型的图5的装置的单元的取向的示例;
图7是根据本发明的各方面的使用第一轴和第二轴的用于凝块夹紧取向的可能激活机构的另一个示例;
图8示出了根据本发明的各方面的处于膨胀部署构型时内部主体和外部主体的单元横交于凝块取回装置的轴线的对准;
图9示出了根据本发明的各方面的在单元围绕装置轴线施加平移和旋转之后处于凝块夹紧构型的图8的装置的单元的取向的示例;
图10是根据本发明的各方面的内部主体和外部主体的对准单元的视图,该对准单元允许凝块迁移穿过处于膨胀部署构型的单元开口;
图11示出了根据本发明的各方面的图10的单元,其中内部主体已围绕轴线旋转到凝块夹紧构型;
图12至图13是概述根据本发明的各方面的凝块取回装置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广泛组成物的凝块,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主体,内部可膨胀主体在该外部可膨胀主体内延伸。本发明所公开的装置共用双层构造的共同主题,其中外部主体和内部主体具有大的单元开口,其中径向力允许凝块的部分迁移到该开口中。然后使外部构件或内部构件中的一者相对于另一个主体平移,使得先前对准的单元开口闭合,从而夹紧内部的凝块的一部分或多个部分。这些夹紧设计增加了凝块取回装置的夹持安全性。
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,但设计也可适用于其他手术和其他身体通道。
接近脉管内的各种血管以到达凝块(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和在该细长轴的远侧端部处构造的可膨胀构件101。可膨胀构件101可具有内部主体110和外部主体210,该外部主体能够在血管闭塞的目标部位处从塌缩或约束递送构型膨胀成膨胀部署构型。递送方法可以是通过例如微导管或其他外部导管,具体取决于目标位置的进入要求。闭塞物可以是血栓(血凝块)、动脉粥样硬化斑块或阻碍血管中血流的一些其他堵塞物。
外部主体210可具有从近侧端部212连接延伸到细长轴6和远侧端部213的大致管状形状。内部主体110还可具有基本上管状轮廓并且延伸穿过外部主体210的内部。内部主体110也可连接到细长轴,但不需要与外部主体210共用连接。换句话讲,两个主体均可固定地连接到轴,但可能不一定在内部主体的近侧端部112处共用同一连接点。某些轴设计可随后允许内部主体110和外部主体210能够相对于彼此选择性地平移,以便能够夹紧和捕获凝块或闭塞物的部分。该凝块夹紧构型可通过例如内部主体110相对于外部主体210的旋转或线性平移来激活。通过增强装置对凝块(尤其是在富含纤维蛋白的凝块的情况)的夹持,夹紧有利于移除凝块。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。
外部主体210的远侧端部213和内部主体110的远侧端部113可围绕可膨胀构件101的轴线111形成环形轮廓,以限定装置100的内部管腔119。外部主体210的远侧端部213可与内部构件110的远侧端部113共面,或者可以很大程度的无创伤轮廓形成另一形状,以便在目标部位处部署和膨胀时避免血管创伤。在一些情况下,对于成角度的撑条可提供更大径向力或最终单元环上的远侧顶点236可用于帮助分离顽固凝块的情况,如图所示的扩张的或具有轮廓的端部可证明具有优势。远侧顶点236可从装置100的纵向轴线111偏移并且可在膨胀时靠近由外部主体210限定的圆柱形平面。
内部主体110和外部主体210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此类合金。细长轴6的一些或全部可为锥形线,或可由不锈钢、MP35N、镍钛诺或具有适当高模量和拉伸强度的其他材料制成。使用具有这些材料的自膨胀主体的优点是,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。这赋予外部主体210在回缩的同时进一步膨胀到更大直径的能力,使得随着外部主体回缩到逐渐变大且更近侧的血管中,外部主体可保持与血管壁接触。
轴6和装置100也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主体210和内部主体110中的一些或全部。
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。外部主体210和内部主体110均为自膨胀支架状结构,其中内部主体的外径大约等于处于自由膨胀状态的外部主体的内径。因此,当外部主体210被约束在血管和/或凝块内时,内部主体110自身将被外部主体约束。在一个示例中,内部主体110的外径在处于其自由膨胀状态的外部主体210的内径的20%以内。在更优选的示例中,内部主体110的外径在处于其自由膨胀状态的外部主体210的内径的10%以内。在最优选的示例中,如果要拆卸装置,则内部主体110的外径等于或略大于处于其自由膨胀状态的外部主体210的内径,使得内部主体不被约束在外部主体内。
外部主体210的径向尺寸可允许其保持与血管壁接触和并置,并且随着装置朝近侧回缩到直径逐渐增大的血管中而防止凝块朝远侧迁移。与血管壁并置还可减小初始从血管分离凝块所需的轴向力。
图2中示出了类似于图1的装置的具有双内部可膨胀主体110和外部可膨胀主体210的复合装置100的侧视图。内部主体110和外部主体210均可为整体结构,其中外部主体被构造成将内部主体基本上包封在其内部。内部主体110的单元114和外部主体210的单元214用作凝块的入口,并且允许装置在回缩时在基本上平行于从血管中拉出凝块的方向(即,基本上平行于纵向轴线111)的方向上向凝块施加力。这意指由外部主体210施加到脉管系统的任何向外径向力可保持在最小值。通过构造外部主体210以便促使凝块横穿内部管腔119,该装置可更有效地使凝块从血管壁脱离。内部主体110和外部主体210也可具有开口远侧端部113、213,或者可被构造成具有片段保护元件(未示出)以防止凝块碎片或其他碎屑在手术期间向远侧迁移。
内部主体110的单元114和外部主体210的单元214可具有各种形状。图2示出了具有大致六边形形状但可为一些其他多边形的单元。内部主体和外部主体的这些单元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。内部主体单元114和外部主体单元214的撑条的六边形布置结构确实允许单元充分伸长和缩短,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110和外部主体210的长度可基本上相同。然而,单元的形状可具有足够的结构刚度,因此装置100可被推进或回缩而不过度延长或缩短内部主体110和外部主体210。
单元114、214的形状可被选择成不显著损害凝块至少部分地进入装置100的内部的能力。在许多情况下,单元可闭合,如图所示,其中内部主体单元114的顶点在内部接合点144处与相邻单元接合在一起,并且外部主体单元214在外部接合点244处与相邻单元接合。在另一个示例中,可存在开放单元和闭合单元的组合,其中开放单元具有从轴向相邻的单元环不连续的撑条环。
内部主体110和外部主体210可被构造成在膨胀到部署构型时产生不同的径向力。这可通过多种方法诸如不同的几何形状、材料来实现,或通过具有不同残余应变的热定形来实现。在一个示例中,外部主体210可具有受限的径向力,以便不引起血管创伤,并且内部主体110可具有更高的径向力,使得强打开力可形成穿过凝块的至少一部分的管腔以在部署时恢复血流。经过管腔的一些数量的受约束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。在其他示例中,外部主体210的径向力和内部主体110的径向力可基本上相等,或者外部主体可具有更大的径向力,以便在主体平移时夹紧并扭转凝块的部分。
装置轴6可被细分成彼此重合并且与装置100的纵向轴线111重合的两个单独的轴,即第一轴8和第二轴7。朝近侧,装置的外部主体210可具有支撑臂222,该支撑臂在近侧接合部处与第一轴8接合并且以锥形方式径向扩张至主体的全直径。支撑臂222可具有如图所示的锥形轮廓,以确保从第一轴8到接合凝块的外部主体210的完全管状轮廓的逐渐刚性转变。支撑臂222的数量和在围绕装置100的纵向轴线111的离散位置处的定位可变化,使得在相邻臂之间存在小周向间隙或大周向间隙。
内部主体110可具有接合到第二轴7的内部支撑臂122。类似于外部主体210的支撑臂222,内部支撑臂122可从内部主体的管状部分到轴7渐缩,并且可平行于纵向轴线111、或与纵向轴线成一角度、或围绕纵向轴线扭转。如果以围绕轴线的扭转形成,则支撑臂122可在装置的内部主体110撤回到外部导管中时引起该内部主体相对于外部主体210的扭转。另选地,可将合适的外部导管推进到装置上以冲击支撑臂122。该旋转扭转可以是闭合内部主体和外部主体的先前对准的单元114、214以在凝块夹紧构型中抓持凝块的另一种方法。类似地,即使已经通过相对平移在内部主体110和外部主体210的单元之间实现了夹紧,但如果需要,仍然可将装置撤回到外部导管中,从而撞击内部支撑臂122和外部支撑臂222以进一步夹紧凝块的近侧部分,同时可膨胀主体的单元可保持对凝块的牢固夹持而不造成干扰。
支撑臂122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单元或至少不在与凝块夹紧单元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。弯曲部或冠部也可帮助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,使得外部主体210能够以低径向力构造。内部主体单元114和外部主体单元214与支撑臂122、222的连接可基本上对准,以在脉管系统内弯曲期间对准内部主体和外部主体的中性轴线。
内部主体110和外部主体210的最远侧部分可为如图所示开放的,或另选地具有以基本上锥形轮廓径向向下滑动到远侧端部213的锥形端部。撑条在端部处的渐缩和会聚可减小撑条之间的单元开口的孔尺寸以形成碎片捕集区。在另一个示例中,可包括鼓胀或扩张的远侧顶点236,使得外部主体210的远侧端部213对使用它的血管而言无创伤。造成鼓胀或扩张的撑条可能不平行于外部主体210的相邻部分的那些。还可向远侧端部213赋予不透射线特性,以在手术期间标记装置100的终端。
图3中示出了具有双层构造的凝块取回装置100的另一个示例,其中内部主体110和外部主体210围绕纵向轴线111设置。在该示例中,内部主体110的单元114和外部主体210的单元214可具有不规则形状,由此撑条具有弯曲部或以曲线方式延伸,该曲线方式从单元的一个组或环到单元的下一个组或环可以不轴向镜像。在该例证中,形成装置的单元环可由正弦形边缘界定,其中它们在内部主体接合部144和外部主体接合部244处交汇。正弦边缘意指径向力的峰和谷的量值(或幅值)可沿装置100的长度变化。该不规则的单元形状可在不同区域中赋予装置锐角和更高的径向压力(每表面积的径向力),以有助于嵌入和夹持凝块。
在凝块的部分接触装置的情况下,低表面积和径向力可允许凝块的部分突出穿过内部主体单元114和外部主体单元214。对于给定水平的径向力,可通过减小构成单元的撑条的数量或撑条宽度来增大装置的径向压力。
细长轴6可被构造成使得可独立地操纵和/或平移内部主体110和外部主体210。平移可以是例如沿轴线的线性平移、一个主体相对于另一个主体的旋转或这些动作的一些组合。使用者可以多种方式将装置100从内部主体110的单元114和外部主体210的单元214在处于膨胀部署构型时对准转变为在凝块夹紧构型中偏移。这种取向变化的示例在图5和图6中示出,其中图5指示当装置首次部署在目标凝块内时初始对准的单元。如图4所示,装置轴6可被细分成彼此重合并且与装置100的纵向轴线111重合的两个单独的轴。轴构造可具有足够刚性的材料或材料的组合,以允许在患者体外的近侧端部处从使用者传递力。第一轴8可连接到外部主体212的近侧端部212,并且第二轴7可连接到内部主体110的近侧端部112。第一轴8可具有管状细长主体320,使得第二轴7可驻留在第一轴的管腔322内。
可通过内部主体110相对于外部主体210的平移或另选地外部主体210相对于内部主体110的平移来实现装置100的凝块夹紧构型。在图4所例示的示例中,分度销312可从第二轴7径向延伸并且驻留在第一轴8的细长主体320中的狭槽324中。如果狭槽324的轴线被布置成平行于纵向轴线111的轴线,如图所示,则使用者可相对于另一个轴推动或拉动一个轴以在主体单元中引起线性平移。
当单元如图5所示对准时,例如,在推动第二轴7时保持第一轴8稳定导致沿内部主体110的轴线111的线性平移,从而相对于外部主体210的单元214闭合内部主体的带有突出凝块的单元114。平移导致单元114、214的新取向,如图6所示。由内部主体110的撑条116形成的成角度接合部144可在平移期间用作网,从而抓持凝块的突出部分并抵靠由外部主体210的撑条216形成的相应接合部244钉住该突出部分。在另选的示例中,在推动或牵拉第一轴8时保持第二轴7稳定导致沿外部主体210的轴线111的线性平移,从而相对于内部主体110的单元114闭合外部主体的单元214,从而钉住突出凝块。还可设想第一轴8和第二轴7两者可同时在相反的方向上平移,从而实现相同的功能。狭槽324的终端可限制允许施加的平移,从而防止意外剪切或失去对所捕获凝块的夹持。在用微导管、中间导管或其他外部护套取回期间部分重新套入装置100可在导管或护套的末端与内部主体110和外部主体210的近侧撑条之间向突出凝块(除了内部主体和外部主体的单元之间的凝块之外)增加额外的夹紧。
使用分度销作为控制装置100转变到凝块夹紧构型的方式的另一个示例在图7中示出。类似于先前的示例,第二轴7可驻留在管状第一轴8的管腔322中,使得轴能够相对于彼此平移和旋转。分度销312可从第二轴7径向延伸并且驻留在切入第一轴8的细长主体320中的狭槽324中,使得狭槽的轴线相对于纵向轴线111形成角度326。如果狭槽324的轴线被布置成平行于纵向轴线111的轴线(参见图4),则使用者可相对于另一个轴推动或拉动一个轴以在主体单元中引起线性平移。然而,如图所示的成角度狭槽意味着第二轴7上相对于第一轴8的推力/拉力导致内部主体构件110相对于外部主体构件210发生线性平移和成角度角旋转两者(参见图7中的箭头)。由于狭槽324引导分度销312的必要行进,来自使用者的单个推力/拉力对于该激活是必要的。该运动从如图8所示的内部主体单元114和外部主体单元214的部署状态转变为如图9所示的单元偏离轴线111和轴线150的凝块夹紧构型。
应当理解,利用激活装置100的凝块夹紧构型的该方法,第一轴8中的狭槽324相对于纵向轴线111的更大锐角326得到内部主体110的单元114与外部主体210的单元214之间的线性平移的更大相对分量。类似地,如果更大钝角326将产生主体围绕轴线111的更大旋转相对分量。
处于膨胀部署构型和在被操纵成凝块夹紧构型之后的装置100的内部主体110和外部主体210的更广泛视图分别在图10和图11中示出。随着微导管在装置部署期间回缩,外部主体210可膨胀并接触血管壁。与壁并置为装置100提供稳定性,并且随着在血管中重新套入装置而使外部主体210与内部主体110之间的部署上的扭转最小化。这通过抵靠血管壁钉住凝块而有利于装置100在栓塞或凝块20中均匀地部署和膨胀。当被部署时,来自主体围绕轴线111膨胀的径向力导致凝块20被推压穿过单元114、214中的开口。
内部主体110和外部主体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。当装置足够长时,凝块可用的许多移动自由度被去除。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。如果随着内部主体110和外部主体210朝向血管壁向外膨胀,凝块容易地穿过这些主体的近侧部分中的单元或间隙向内迁移,则可避免这种压缩。
当通过利用内部主体110和外部主体210的相对位移和/或旋转(图11中的箭头)来激活凝块夹紧构型时,形成内部主体单元114的撑条116不再与形成外部主体单元214的撑条216对准,如图11所示。凝块20在形成单元的撑条之间变为受到冲击和压缩,从而允许夹紧紧紧地夹持凝块的区域以进行初始分离和随后从血管中取出。
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另选形式来实现。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可涉及跨目标凝块递送凝块取回装置。凝块取回装置可通过微导管或其他合适的递送导管递送,并且在递送期间具有塌缩构型,并且在递送导管回缩时具有膨胀部署构型。使用者可使用细长轴操纵装置。可膨胀元件可附接到细长轴的远侧端部并且具有沿纵向轴线延伸的外部主体,该外部主体具有基本上管状管腔。内部主体可沿轴线设置在外部主体的管腔内,并且能够比外部主体更小程度地径向膨胀,使得其被完全容纳。内部主体和外部主体能够相对于彼此沿纵向轴线和/或围绕纵向轴线平移,使得装置从部署构型转变为以凝块夹紧构型夹紧并夹持凝块。
在许多情况下,内部主体可膨胀到仅略小于外部主体的总直径,并且被构造成产生可大于、小于或等于外部主体所产生的径向力的径向力。这允许针对目标凝块的尺寸、位置和组成定制内部主体和外部主体,以便增大装置首过成功的概率。
内部主体和外部主体均可由形成多个单元的撑条制成。单元可为多种形状和尺寸中的任一种。在步骤1220中,主体可被构造成使得当膨胀和部署时,两个主体的单元中的开口在轴向方向和周向方向上均大部分对准。单元可具有大的中心开口,使得当膨胀时,装置可并置血管壁,同时由撑条提供的受限支架压缩并嵌入目标凝块。附近的凝块的部分可随后容易地同时向内穿过内部主体单元和外部主体单元中的间隙。
装置可被构造成使得细长轴由连接到外部主体的近侧端部的第一轴和连接到内部主体的近侧端部的第二轴构成,如步骤1230所示。第二轴可例如与第一轴重合,使得其可选择性地用于独立于外部主体线性地平移或旋转内部主体。类似地,第一轴可用于独立于内部主体线性地平移或旋转外部主体。
另选地,在该步骤中可利用一些其他机构来夹紧凝块。例如,内部主体或外部主体的近侧支撑臂可与纵向轴线成一角度形成,使得如果微导管或外部导管被推进到支撑臂超过可膨胀主体的近侧端部,则可在主体中的一个主体上相对于另一个主体施加扭转。
可通过微导管将处于塌缩递送构型的装置递送到阻塞的血管。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。然后微导管可回缩,从而允许凝块取回装置在闭塞凝块内以及任一侧膨胀。
步骤1240涉及将凝块取回装置部署成膨胀部署构型。由装置的内部主体和外部主体施加的径向力可推压凝块的至少一部分径向向内穿过对准的单元开口。可控制并最小化凝块压缩,因为所施加的径向力不需要非常高,原因是凝块的大部分不必完全进入装置的内部管腔。使凝块的压缩最小化减小了在分离和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,该步骤将内部主体相对于外部主体或将外部主体相对于内部主体平移,以在压缩下将凝块的至少一部分夹紧在内部主体单元和外部主体单元的撑条之间。平移可以是线性运动、旋转或这两者的组合。平移的发生可通过如前所述的具有内轴和外轴的系统来实现。另选地,在装置的被设置为螺旋形的近侧部分上方推进外部导管可对装置的螺旋形部分施加切向力,以相对于其他部分扭转和/或旋转。无论如何,相对平移用于在压缩下将凝块夹紧在内部主体的单元的撑条与外部主体的单元的撑条之间。该步骤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。如果在手术期间有必要,反转步骤1310的过程可使装置从凝块夹紧构型转变回膨胀部署构型。
如果推进微导管或其他外部导管以增强对凝块的夹紧,使用者可感觉到作为阻力的夹紧并停止推进导管,或者另选地可在可膨胀主体的近侧端部上方推进固定距离。可膨胀主体中相对低水平的支架允许保持装置与导管之间的相对张力,使得在凝块回缩期间夹紧不会恶化。
在步骤1320中,内轴或外轴可具有特征结构,诸如狭槽中的销或凸轮和从动件布置结构,以在转变到凝块夹紧构型和从凝块夹紧构型转变时限制内部主体与外部主体之间的总相对运动。限制平移确保凝块被夹紧,但不被剪切或破碎。
在步骤1330中,可从血管中撤回带有夹紧的凝块的凝块取回装置,同时保持内部主体和外部主体的单元之间的夹紧。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,所述装置具有约束递送构型和膨胀部署构型,所述装置包括:
第一轴、第二轴和撑条框架,所述撑条框架形成从所述第一轴和所述第二轴朝远侧延伸的可膨胀构件,所述可膨胀构件包括:
内部管状管腔和延伸穿过其的纵向轴线;
内部主体,所述内部主体连接到所述第二轴并且包括能够围绕所述纵向轴线以所述部署构型膨胀的多个单元;和
外部主体,所述外部主体连接到所述第一轴并且包括能够以所述部署构型膨胀到比所述内部主体更大程度的多个单元;
所述内部主体和所述外部主体能够围绕所述纵向轴线在所述部署构型和凝块夹紧构型之间相对于彼此平移;以及
所述内部主体的所述单元和所述外部主体的所述单元被构造成在处于所述凝块夹紧构型时夹紧位于所述单元中的凝块。
2.根据权利要求1所述的装置,其中所述内部主体的所述单元在尺寸上大致等于所述外部主体的所述单元。
3.根据权利要求1所述的装置,其中处于所述膨胀部署构型时,所述内部主体的所述单元与所述外部主体的所述单元对准。
4.根据权利要求1所述的装置,所述内部主体和所述外部主体的所述单元被构造成以所述膨胀部署构型嵌入所述凝块中。
5.根据权利要求1所述的装置,通过相对于所述外部主体平移所述内部主体直到所述凝块的至少一部分被压缩在所述内部主体的所述单元与所述外部主体的所述单元之间来实现所述凝块夹紧构型。
6.根据权利要求1所述的装置,所述第一轴包括细长主体、内部管腔和接近其远侧端部的狭槽。
7.根据权利要求6所述的装置,所述第二轴设置在所述第一轴的所述管腔内并且包括从所述第二轴的外表面径向延伸的分度销,所述分度销被构造成与所述第一轴的所述狭槽接合。
8.根据权利要求7所述的装置,所述狭槽的所述轴线与所述纵向轴线形成角度,使得所述第二轴相对于所述第一轴的线性平移导致所述分度销在所述狭槽内的旋转。
9.根据权利要求1所述的装置,所述内部主体和所述外部主体的区域被构造成对所述凝块施加向外的径向力,以朝向所述内部管状管腔推压所述凝块。
10.一种用于治疗身体血管中的闭塞物的装置,所述装置包括:
管状内部管腔,所述管状内部管腔围绕纵向轴线构造;
内部主体,所述内部主体包括约束递送构型、膨胀部署构型以及形成内部凝块支架节段的多个撑条;
外部主体,所述外部主体围绕所述内部主体设置并且包括约束递送构型、膨胀部署构型以及形成外部凝块支架节段的多个撑条;和
细长轴,所述细长轴在所述内部主体和所述外部主体的近侧延伸;
所述内部主体和所述外部主体能够围绕所述纵向轴线在所述部署构型和凝块夹紧构型之间相对于彼此平移;以及
当所述内部主体处于所述凝块夹紧构型时,凝块的至少一部分被压缩在所述内部主体的所述撑条与所述外部主体的所述撑条之间。
11.根据权利要求10所述的装置,其中所述内部主体和所述外部主体的所述支架节段的所述撑条形成单元环。
12.根据权利要求11所述的装置,其中所述内部主体的所述单元在尺寸上大致等于所述外部主体的所述单元。
13.根据权利要求11所述的装置,其中处于所述膨胀部署构型时,所述内部主体的所述单元与所述外部主体的所述单元对准。
14.根据权利要求10所述的装置,所述内部主体和所述外部主体的所述支架节段被构造成对凝块施加向外的径向力,以朝向所述内部管状管腔径向向内推压所述凝块。
15.根据权利要求10所述的装置,其中所述轴包括连接到所述外部主体的第一轴和连接到所述内部主体的第二轴。
16.根据权利要求15所述的装置,所述第一轴和所述第二轴被构造成使所述内部主体相对于所述外部主体平移。
17.根据权利要求10所述的装置,所述内部主体(110)和所述外部主体(210)的所述支架节段的所述撑条被构造用于以所述膨胀部署构型嵌入凝块中。
18.一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:
跨所述凝块递送凝块取回装置,所述凝块取回装置包括:
塌缩递送构型、膨胀部署构型、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,所述内部主体包括多个单元;
外部主体,所述外部主体围绕所述内部主体沿纵向轴线延伸并且包括多个单元并且能够以所述部署构型膨胀到比所述内部主体更大的程度;
所述内部主体和所述外部主体被构造成围绕所述纵向轴线在所述部署构型和凝块夹紧构型之间相对于彼此平移;
将所述凝块取回装置部署成所述膨胀部署构型,使得所述内部主体和所述外部主体的所述单元对准;
用所述装置施加径向力,使得所述凝块的至少一部分被径向向内推压穿过所述内部主体和所述外部主体的所述单元开口;
相对于所述外部主体平移所述内部主体,以在压缩下将所述凝块的至少一部分夹紧在所述内部主体单元和所述外部主体单元的所述撑条之间;
从所述血管中撤回所述凝块取回装置,同时保持所述内部主体与所述外部主体之间的所述相对平移的至少一部分,以保持对所述凝块的夹持;以及
将所述凝块取回装置和夹紧的凝块从患者移除。
19.根据权利要求18所述的方法,所述细长轴包括连接到所述外部主体的第一轴和连接到所述内部主体的第二轴,所述第一轴和所述第二轴被构造成能够相对于彼此选择性地移动;以及
所述第一轴选择性地对所述外部主体施加相对于所述内部主体的运动并且所述第二轴选择性地对所述内部主体施加相对于所述外部主体的运动。
20.根据权利要求19所述的方法,所述第一轴被构造成限制所述第二轴的平移范围。
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