CN114681005A - 富含纤维蛋白/柔软凝块机械血栓切除装置 - Google Patents
富含纤维蛋白/柔软凝块机械血栓切除装置 Download PDFInfo
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Abstract
本发明公开了能够从身体血管中移除紧实凝块和柔软凝块两者的装置的设计,该设计可具有双层,其中单元的内部可膨胀主体在单元的外部可膨胀保持架内延伸。该设计的特征可在于受限的递送构型和膨胀部署构型。外部保持架可具有宽开口撑条,以允许凝块结合到装置中。内部主体和外部保持架两者均可被构造成具有夹紧凝块并且将凝块嵌入其中的形状。该装置还能够使外部保持架的一部分折叠并且在与目标凝块接合之后朝近侧倒置以将凝块置于内部。这些因素可增强装置捕获所有组成的凝块的能力,从而允许更安全且更有效的流动恢复。
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身体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
可使用机械装置和方法从血管中移除急性阻塞物。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,希望凝块取回装置与薄型和柔性通路导管尽可能相容。
支架状凝块取回器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可能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伤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,所以某些常规血栓切除装置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,其中捕获的凝块可能逃脱。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运动,这减小了撑条中的张力,但也减小了装置的膨胀直径。
在此环境下寻求手术效率时,具有多个主体的凝块取回装置通常是优选的。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。此外,由于这些装置被设计成使得通常需要凝块径向向内地迁移穿过外部构件,因此装置可在凝块的周边区域上具有不太牢固的夹持。
另外,常规血栓切除装置通常旨在移除富含纤维蛋白的或柔软的凝块。目前,在引入血栓切除装置之前,无法识别凝块是富含纤维蛋白的还是柔软和易碎的(或两种情况的一些组合),从而阻止了使用者知道哪个装置将提高首过成功概率以降低对患者的风险。此外,凝块异质性可能意味着凝块可在整个凝块解剖结构的近侧部分、中心部分或远侧部分中包括富含纤维蛋白的芯,从而使得均匀且牢固的夹持更加困难。
对于任何装置需要克服上述挑战以便在移除任何类型的凝块、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
本发明所公开的设计通过提供柔性双层凝块取回装置来解决这些问题,其中内部构件和外部构件协同工作以捕获和移除凝块。该设计可旨在用作首过装置,其特征是在捕获富含纤维蛋白的粘性凝块方面与它们是柔软、易碎的凝块一样有效。
该设计的特征可在于受限的递送构型和膨胀部署构型。外部构件可具有宽开口撑条,以允许凝块结合到装置中。内部构件和外部构件两者均可被构造和成形为夹紧凝块并且将凝块嵌入其中。在一些示例中,装置的至少一些部分能够在与目标凝块接合之后朝近侧折叠并倒置,以将凝块倒置于内部并保护凝块。这些动作可增加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。
该装置可具有用于操纵的近侧管状轴,该近侧管状轴具有延伸穿过其的管腔。该轴可根据应用而具有各种尺寸。在一个示例中,轴是外径小于或等于0.021英寸的海波管。在另一个示例中,轴可具有约0.026英寸的外径。轴的远侧可以是撑条框架,该撑条框架具有受限的递送构型、部署在目标部位处时的膨胀凝块接合部署构型以及至少部分受限的凝块夹紧构型。
在一些示例中,撑条框架可形成细长内部主体和外部保持架。在一种情况下,可由单个连续海波管激光切割出内部主体和外部保持架。在另一种情况下,可全部由同一连续海波管切割出近侧轴、内部主体和外部保持架。内部主体可具有远侧端部、纵向轴线和一个或多个凝块夹紧单元,该一个或多个凝块夹紧单元被构造成在装置从部署构型转变为凝块夹紧构型时夹紧凝块。外部保持架可布置在内部主体周围,可从内部主体的远侧端部延伸,或者为这些情况的一些组合。外部保持架能够膨胀到大于膨胀内部主体的径向范围,或者其可具有相同或相似的径向尺寸。
凝块夹紧结构可采用多种形式。该夹紧结构可具有一系列凝块接收孔。单元可由在冠部之间延伸的一个或多个柔性撑条组成。单元可在单元的近侧端部和远侧端部处具有马蹄形鞍点,使得单元能够在撑条处于径向压缩时收缩单元中的凝块的部分。这些图案允许微导管或外部导管在夹紧结构单元的近侧端部上方推进,以便随着装置从膨胀部署构型转变为部分受限的凝块夹紧构型,压缩并抓持位于导管的末端与单元的撑条的至少一部分之间的凝块。在另一个示例中,凝块夹紧结构可以是以起伏或螺旋方式布置的撑条的平坦图案。
内部主体和外部保持架的特性可彼此独立地进行定制。外部保持架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保持架的管腔内。
在一些示例中,牵拉线可延伸穿过近侧管状轴的管腔并且在连接点处固定地连接到外部保持架。连接点可为压接夹具、焊接件或编织物中的至少一者。使用者操纵轴的近侧端部处的牵拉线可使外部保持架从膨胀部署构型转变为倒置凝块外壳构型。在此转变期间,牵拉线可倒置外部保持架,使得其至少一部分在转变点处折叠并且朝近侧折回到内部主体上方。因此,外部保持架的撑条可以凝块外壳构型包封凝块和内部主体。这种倒置可将凝块的柔软部分和紧实部分两者置于内部并容纳两者,以供后续回缩和移除。在一些情况下,外部保持架的剩余远侧部分也可在激活牵拉线时径向向外张开,以在凝块取回期间用作碎片保护元件。
在一些示例中,内部主体和外部保持架的径向尺寸可取决于应用和目标闭塞物在脉管系统内的潜在位置而热定形和变化。对于神经血管中的目标,细长内部主体在膨胀部署构型中可具有约2.25mm的外径。类似地,外部保持架在膨胀部署构型和倒置凝块外壳构型中可具有约5mm的外径。
凝块取回装置的另一种设计可具有纵向轴线、近侧轴、内部主体、外部保持架和连接到外部保持架的远侧端部的锥形撑条网片。内部主体、外部保持架和撑条网片可具有受限的递送构型、膨胀部署构型和至少部分受限的凝块夹紧构型。在凝块上部署之后,通过在内部主体的近侧端部和外部保持架的近侧端部上方推进导管,直到凝块的至少一部分被压缩在导管的末端与内部主体、外部保持架或内部主体和外部保持架的组合的撑条的至少一部分之间,可实现凝块夹紧构型。
在一些示例中,内部主体可具有形成一系列凝块接收单元的撑条。在膨胀部署构型中,单元可被热定形以沿纵向轴线以大致正弦波图案延伸。在另一个示例中,单元围绕轴线形成螺旋图案。在一种情况下,内部主体的单元被构造成在膨胀时嵌入并稳定凝块。在另一种情况下,内部主体的单元可具有被构造成嵌入并稳定凝块的至少一部分的至少一个弯曲部。内部主体可为径向尺寸范围。在一些示例中,内部主体在膨胀部署构型中可具有1.25mm至1.5mm范围内的外径。
外部保持架可具有沿装置的长度以轴向方式延伸的一系列节段。每个节段可具有一个或多个单元。在一些示例中,每个节段可具有两个单元。外部保持架的每个单元可具有位于单元的近侧端部和远侧端部处的马蹄形鞍点,该马蹄形鞍点被构造成随着装置运动到凝块夹紧构型而压缩并夹紧凝块的至少一部分。通过在内部主体的近侧端部和外部保持架的近侧端部上方推进导管,直到随着撑条被径向压缩,凝块的至少一部分被压缩在导管的末端与外部保持架的撑条的至少一部分之间,可实现凝块夹紧构型。相邻的轴向节段可通过柔性连接撑条以铰接方式接合,该柔性连接撑条可为相应节段之间的唯一接触点。因此,随着装置被推进或回缩穿过脉管系统中的弯曲部,这些节段可独立地挠曲。
取决于在脉管系统内的目标位置,外部保持架可为各种尺寸。在一个示例中,外部保持架在膨胀部署构型中可具有约3mm的外径。在另一个示例中,外部保持架在膨胀部署构型中可具有约5mm的外径。
内部主体和外部主体可共用相同的轴并且围绕纵向轴线同轴。在与轴的近侧接合部接头处,外部保持架可具有包围轴的完全周向管状外衬圈。内部主体可通过激光切割外径小于外部保持架的外衬圈的内径的管而形成。因此,内部主体可在近侧接合部处具有衬圈,该近侧接合部可在外衬圈内滑动。
一种使用本发明所公开的示例作为首过装置从血管中提取紧实凝块和柔软凝块两者的方法可包括具有内部主体、外部保持架和近侧轴的装置。内部主体可通过激光切割管而一体地形成,并且具有形成被构造成嵌入凝块的至少一部分的单元的撑条。在一些情况下,外部保持架也可从同一连续管切割并且朝内部主体的远侧延伸。在其他情况下,外部保持架可沿纵向轴线围绕内部主体延伸并且能够膨胀到大于内部主体的径向范围。外部保持架还可具有形成单元的撑条,该单元被构造成嵌入凝块的至少一部分,但也允许凝块的部分径向向内迁移。该装置可具有受限的递送构型、膨胀部署构型和至少部分受限的凝块夹紧构型。
该方法可包括将装置递送到与目标凝块的部位相邻的血管的步骤。凝块组成可为紧实的、柔软的、或紧实部分和柔软部分两者混合的。可通过将装置从受限的递送构型膨胀到膨胀部署构型,使装置未被套入以将外部保持架的单元中的至少一个单元和内部主体的单元中的至少一个单元嵌入凝块中。
另一个步骤可涉及朝远侧推进外部导管,使得外部导管与内部主体和外部保持架的近侧端部接合并撞击在其上,以利用内部主体和外部保持架的单元夹紧压缩凝块的至少紧实部分。外部导管可为微导管、进入导管或其他合适的外部护套。在装置撤回时可保持夹紧,从而不失去对凝块的夹持。
在一些示例中,内部主体和/或外部保持架的单元可具有形成弯曲或马蹄形鞍点的撑条,其被成形为通过朝远侧推进外部导管而被压缩。该方法于是还可包括以下步骤:当与外部导管接合时,将凝块的至少一部分夹紧在内部主体单元中的至少一个单元的马蹄形鞍点中。另选地或除此之外,该方法还可包括以下步骤:当与外部导管接合时,将凝块的至少一部分夹紧在外部保持架单元中的至少一个单元的马蹄形鞍点中。
如果凝块易碎并且刚性不足以实现夹紧,则当装置的轴回缩或朝远侧推进外部导管时,使用者可能感觉到缺乏触觉阻力。在这种情况下,可撤回外部导管,并且可将装置重新部署到膨胀构型以嵌入凝块。在一些示例中,外部保持架的撑条可倒置回装置上方,并且该方法可涉及朝近侧倒置撑条以将凝块和内部主体置于内部的步骤。当外部保持架撑条倒置时,内部主体可保持在适当位置,使得凝块不被朝近侧推动。
当装置捕获紧实凝块和/或柔软凝块时,该方法可涉及从患者体内移除凝块取回装置和捕获的凝块的步骤。这可例如通过使用抽吸将装置朝近侧取回到引导导管中来完成。如果可夹紧凝块的紧实部分,则可在该步骤期间保持夹紧,从而不失去对凝块的夹持。另外,如果外部保持架的撑条已朝近侧倒置(使用张紧的牵拉线或其他方法)以将凝块倒置于内部并帮助固定凝块,则也可保持该构型。
在取回一些或全部闭塞性凝块之后,可对血管的通畅程度进行评估。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。然而,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是根据本发明的各方面的凝块取回装置的视图;
图2示出了根据本发明的各方面的图1的凝块取回装置,其中使用牵拉线使外部保持架的撑条朝近侧倒置;
图3A至图3C示出了根据本发明的各方面的用于捕获具有柔软组成部分和紧实组成部分两者的凝块的凝块取回装置的使用方法;
图4A至图4B示出了根据本发明的各方面的用于捕获柔软凝块的凝块取回装置的使用方法;
图5A至图5B示出了根据本发明的各方面的图4A至图4B中的方法步骤的延续;
图6是根据本发明的各方面的凝块取回装置的另一个示例的平面图;
图7是根据本发明的各方面的图6的凝块取回装置的正视图;
图8示出了根据本发明的各方面的图6的凝块取回装置的内部主体的透视图;
图9a示出了根据本发明的各方面的图6的内部主体的平面图;
图9b示出了根据本发明的各方面的图6的内部主体的正视图;
图10是根据本发明的各方面的用于图6的凝块取回装置的示例性近侧接头的视图;
图11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各种组成的凝块,同时在手术期间保持高水平的可递送性和灵活性。该设计可以是首过凝块取回装置,其可用于移除任何凝块类型,无论它们是紧实且粘性的、柔软且易碎的、还是两者的组合。
该设计可具有外部可膨胀保持架,内部可膨胀主体在该外部可膨胀保持架内延伸。内部主体和外部保持架可具有大开口,其中径向力允许凝块的部分迁移到开口中。内部主体和外部保持架中的一者或两者的单元可具有被构造成在外部导管在装置上朝远侧推进时夹紧凝块的至少一部分的特征结构。这些夹紧设计增加了凝块取回装置的夹持安全性。该装置还可被构造成使得该装置的至少一部分可朝近侧倒置以在取回期间将凝块倒置于内部和保护凝块。
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。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。
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。这些产品是熟知的并且广泛用于实验室和医学规程中。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。
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。
参见图1,凝块取回装置100可具有细长轴6,撑条框架102从该细长轴朝远侧延伸,其中内部主体110和外部保持架210能够在血管闭塞物或凝块的目标部位处从塌缩或受限的递送构型膨胀到膨胀部署构型。递送方法可以通过例如微导管13或其他外部导管或护套,具体取决于目标位置的进入要求。在暴露超过微导管13的远侧端部时,装置100可自膨胀到图1所示的部署构型。闭塞物通常是阻碍血管中血流的血栓(血凝块)。具有带有内部主体110和外部保持架210两者的构型允许凝块保持在装置内,这可最小化移除期间血管损伤的风险。
内部主体110可为形成轴向系列单元116的撑条的网络。单元116的撑条在膨胀时可具有高径向力,以有助于将单元互穿并嵌入凝块内。每个单元的近侧端部和远侧端部可渐缩成大致“U”形或马蹄形鞍点118。鞍点118的这种形状允许单元116在微导管13或另一个外部导管在装置的近侧端部上方推进时径向收缩。这种收缩可夹紧嵌入在一个或多个单元内的凝块的紧实部分。
具有多个夹紧单元116可有利于捕获在凝块内的近侧位置、中心位置和/或远侧位置具有纤维蛋白芯的凝块。随着装置回缩到外部导管中,单元可紧紧地夹持凝块,直到感觉到阻力,这表明可通过抽吸进一步固定的夹紧夹持件。
通过增强装置对凝块(尤其是在主要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。
相邻单元116的端部可通过柔性连接撑条117连接。连接撑条117可充当单元之间的铰接部并且可为相邻单元之间的唯一接触点。因此,随着装置被推进或回缩穿过脉管系统中的弯曲部,单个单元可独立地挠曲,并且可对由捕获的凝块施加在装置上的力作出局部响应。
外部保持架210可固定地连接到内部主体110的远侧端部114。外部保持架210的轻微弯曲的环可在远侧端部4附近赋予装置100无创伤轮廓。在一些示例中,内部主体110和外部保持架210可一体地形成,由此内部主体的撑条转变为外部主体的撑条并呈现外部主体的形状。这在图1中示出,其中内部主体110的远侧端部114处的转变点115向外部主体210的更大环状结构进行转变。从同一管切割并热定形内部主体110和外部保持架210可简化制造过程并且消除装置中刚度梯度的潜在扭结点。
外部保持架210的撑条可为非常柔性的,具有低径向力,以允许通过牵拉线218或其他合适的致动方法来操纵撑条,从而根据需要改变外部保持架的形状。撑条的柔性还允许外部保持架210塌缩至内部主体110的外径122,用于导航通过较窄的血管。
内部主体110和外部保持架210可优选地由超弹性或伪弹性材料诸如镍钛诺或具有高可恢复应变和适当高的模量和拉伸强度的其他此类合金制成。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,使得随着外部保持架回缩到逐渐变大且更近侧的血管中,外部保持架可并置血管壁。
在一个示例中,可从也用作轴6的单件连续管材激光切割出内部主体110和外部保持架210。如果需要,具有兼作为管的轴6可允许轴管的管腔7用作牵拉线218或其他致动构件或装置的管道。
管材可为原材料形式,例如镍钛诺海波管,使得内部主体110和外部保持架210的撑条可被激光切割并热定形为期望的形状和尺寸。例如,当膨胀到部署构型时,内部主体110可被热定形为具有约2.25mm的外径122。类似地,在相同的部署构型中,外部保持架210可被热定形为具有约5.00mm的外径222。该装置因此可有效地弹簧加载在微导管内并且在部署在目标部位处时膨胀到这些尺寸。
外部保持架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示出了图1的装置100在捕获凝块(未示出)之后的示例性构型。内部主体110的单元116可用作入口以稳定凝块,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8)的方向上向凝块施加力。这也意指由外部保持架210施加到脉管系统的任何向外径向力可保持在最小值。
当内部主体110的单元116已嵌入凝块内时,牵拉线218可被张紧和回缩以使外部保持架210的柔性撑条朝近侧倒置,如图所示,以将内部主体和凝块倒置于内部。可使用定位在装置轴的近侧端部处的柄部来取回牵拉线218。线218可牵拉较大直径的外部保持架210,同时内部主体110留在适当位置,使得可在内部主体单元116的鞍点118、微导管13与凝块的至少紧实部分之间保持夹紧,如所述。
当倒置时,外部保持架210的特征可在于围绕纵向轴线8和内部主体110设置的一系列宽环节段216。在内部主体远侧端部114处,内部主体/外部保持架转变点115可形成远侧冠部220以在凝块移除期间充当节段保护元件,从而防止碎片的远侧迁移。冠部220还可具有类似于目标血管的直径的扩张直径,使得其可帮助从凝块的易碎部分牢固地捕获碎片。
轴6可为被选择成与通常可用的递送护套相容的原料管材尺寸。在一个示例中,轴6的外径9可小于约0.021英寸,以确保与0.021英寸内径的微导管相容。在另一个示例中,轴6可具有约0.026英寸的略大外径,以与0.027英寸内径的微导管相容。
轴6和装置100的其他部分也可具有指示带或标记(未示出),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也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和内部主体110中的一些或全部。
图3A至图3C示出了在脉管系统40中使用装置100来捕获具有紧实组成部分和柔软组成部分两者的非均匀凝块20、22的方法。在图3A中,可从微导管13将装置部署在凝块中,其中内部主体110区段的单元116暴露于凝块。可随后朝远侧推进微导管13以重新套入内部主体110的单元116和牵拉线218的至少一部分。另选地,可使用另一种外部导管或护套。鞍点118可形成单元116径向向下折叠的自然拐点。如果存在凝块的富含纤维蛋白的部分20,则单元116可实现凝块的区段在内部主体110与微导管之间的夹紧,如图3B所示。
一旦实现夹紧并且使用者感觉到所得阻力,就可通过轴6回缩牵拉线218。牵拉线在联接点219处将外部保持架210的较大直径热定形部分朝近侧牵拉,同时使内部主体110留在适当位置以保持夹紧。牵拉线218的取回将外部保持架210的环节段216撤回到凝块的紧实部分20和柔软部分22两者上,以将整个凝块置于外部保持架内,如图3C所示。可随后将完整的装置与凝块一起撤回到引导导管或其他外部护套中。
牵拉线218与外部保持架210的撑条之间在连接点219处的结合可通过多种方法进行。在一些示例中,可利用机械连接,诸如压接件、编织物或球状物/金属圈组合。在其他情况下,可使用热工艺,诸如焊接或硬钎焊。
图4A至图4B以及图5A至图5B示出了如果仅存在柔软凝块22,使用该装置的方法。该装置可部署在凝块22中,使得内部主体110的单元116可暴露于并嵌入凝块中,如图4A所示。在图4B中,可朝远侧推进微导管13以重新套入内部主体110的单元116和牵拉线218的至少一部分,以尝试夹紧凝块,如图4B所示。如果使用者感觉不到内部主体110与微导管之间的夹紧阻力,则表明凝块22是柔软的(没有一个或多个富含纤维蛋白的部分)。可随后将装置重新部署出微导管13以嵌入内部主体110并稳定凝块(图5A)。使用者可随后张紧牵拉线218并朝近侧拉动牵拉线以倒置外部保持架210,同时将内部主体110留在适当位置以将柔软凝块22倒置于内部(图5B)。冠部220可防止凝块碎片的远侧迁移,同时完整的装置和凝块被撤回到引导导管中。
在图6的平面图中看到能够作为用于捕获紧实凝块和柔软凝块两者的首过装置的凝块取回装置300的另一个示例。装置300可具有用于通过微导管递送的受限的递送构型、膨胀部署构型以及用于夹持紧实或富含纤维蛋白的凝块的至少部分受限的凝块夹紧构型。装置300可具有纵向轴线8、近侧轴6以及形成内部主体310和外部保持架410的撑条的可膨胀结构。类似于其他设计,内部主体310和外部保持架410可由形状记忆合金诸如镍钛诺切割而成,以允许撑条在膨胀时热定形为所需形状。内部主体310和外部保持架410可帮助将凝块保持在装置内,以降低取回期间损伤血管壁的风险,因为未抵靠血管壁掠过凝块以便夹持。
内部主体310可被构造成在移除过程期间稳定凝块并且为特别软的凝块增强支撑和额外的夹持。内部主体310可以是被设计成具有“s波”或正弦波最终热定形形状的薄型系列凝块接合单元。薄型设计使得内部主体310和外部保持架410之间具有更多凝块接收空间,以在将装置取回到中间导管或其他外部导管中时最小化凝块剪切。在一个示例中,内部主体310可具有在约1.25mm至1.5mm范围内的膨胀外径。在其他示例中,当内部主体和外部保持架被压接在一起而进入微导管以便递送到目标部位时,内部主体可具有由透视缩短方面的差异确定的膨胀直径。
图7示出了图6的装置300的侧正视图。外部保持架410可具有围绕内部主体310设置的一系列轴向主体节段412,并且被热定形为具有比内部主体的内径322显著更大的外径422。在一些优选的示例中,该外径422可为约5mm。每个节段412可具有一个或多个单元416,在每个单元的近侧端部和远侧端部处具有马蹄形鞍点418。
例如,图6至图7所示的装置300围绕纵向轴线8的每个节段412具有垂直于彼此的两个单元416。需注意,由于分别从如图6和图7所示的平面图和正视图查看单元416的垂直性质,主体节段412中的每个单元可具有180度曲率,其中当装置300旋转90度时,柔性连接撑条417用作相邻单元的顶部/底部。因此,结果可为外部保持架410围绕纵向轴线8的圆柱形状。
外部保持架410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运动。当装置足够长时,凝块可用的许多运动自由度被去除。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。如果凝块可容易地向内迁移穿过外部保持架的单元,则可避免这种压缩。
因此,来自图6和图7所示的装置300的单元416可具有宽开口撑条,以使得单元一旦部署在凝块中凝块就径向迁移穿过外部保持架410。类似于其他示例,部署之后朝远侧推进微导管或其他导管可压缩每个单元416的鞍点418,以夹紧凝块的富含纤维蛋白的部分,从而在移除期间进行牢固夹持。
外部保持架410的相邻节段412可通过柔性连接撑条417接合。随着鞍点418使每个节段412的单元416的端部渐缩为点,单个连接撑条417可为相应节段之间的唯一接触点。这允许节段围绕连接撑条铰接,以改善装置柔性和血管壁并置。连接撑条还可允许各个节段的单元416局部打开至增大的直径,以保持对内部主体310和外部保持架410之间的凝块的良好夹持。在目标凝块中的一些或全部位于困难解剖结构诸如分叉中的情况下,局部增大到较大直径的能力可能特别有用,从而允许凝块保持在血管内。
外部保持架410还可具有最终节段,该最终节段具有锥形网片端部420,以用于防止小碎片从主凝块破裂并在更小、更远侧的血管中重新闭塞。网片端部420还可帮助防止凝块的区段在取回期间随着其翻转或改变形状而脱离。形成该节段420的远侧撑条可鼓胀或扩张,使得外部保持架410的远侧端部对使用它的血管而言无创伤。这些撑条的渐缩和会聚还可减小网片的孔尺寸以形成有效的碎片捕获区。
图8示出了图6和图7的装置300的内部主体310的透视图。可以看出主体单元316的正弦波形设计,因为撑条包含图案的振幅峰317之间的弯曲部319。单元316的弯曲部319可偏置运动远离外部保持架410的凝块夹紧单元416或至少不在与其相同的方向上,使得当装置的近侧部分部分受限的在凝块夹紧构型中时,内部主体310稳定但不剪切凝块的部分。弯曲部或冠部也可帮助提供对凝块的更好抓持,具体通过针对使凝块从血管脱离的关键初始步骤嵌入并平衡凝块,使得外部保持架410能够以低径向力构造。
内部主体310的单元316和波形形状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316的撑条的波形布置结构还允许单元充分伸长和缩短,使得当在微导管中加载时以及当在目标部位处自由膨胀时,内部主体310和外部保持架410的长度可基本上相同。然而,单元仍可具有足够的结构刚度,因此装置300可被推进或回缩而不过度延长或缩短内部主体310和外部保持架410。
内部主体310还可从单个单元正弦曲线图案朝远侧转变到径向膨胀的撑条318的集合中。在所示的示例中,四个膨胀撑条318可围绕纵向轴线等距间隔90度定位。扩张或膨胀的撑条可促成外部保持架410的远侧网片碎片节段420。在将装置压接到插入工具或微导管中期间,膨胀的撑条还可对齐内部主体310和外部保持架410的透视缩短。
图9A和图9B分别提供独立于装置300的外部保持架410的图8的内部主体310的顶视图和侧视图。图9A示出了内部主体310中的单元开口316的序列。每个波可具有单个单元开口316。单元可具有约1.25mm至1.5mm的直径,或者可具有由在将装置压接到插入工具或微导管中期间内部主体310和外部保持架410的透视缩短方面的差异确定的略微不同的直径。靠近远侧端部314的膨胀的撑条318可具有比内部主体310的单元316更大的外径(更接近外部保持架的膨胀外径),并且因此这些撑条还可构成内部主体与外部保持架之间所需的收缩长度的显著一部分。
图9B示出了图9A的侧视图,清楚地示出了内部主体310的单元316的正弦波图案315。图案的最近侧单元可终止于连接撑条330,该连接撑条将该最近侧单元连接到内部主体的近侧端部312处的部分周向内衬圈328。通过单个海波管切割并机加工成具有等于衬圈外径的外径324,内部主体的撑条可与衬圈328一体地形成。内部主体310的远侧端部314处可具有射线不可透的线圈310或标记带,以在手术期间标记装置的终端。
内部主体310和外部保持架410与细长轴6的近侧连接可被构造成使得内部主体和外部保持架可相对于彼此具有一些少量的独立平移。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。图10中的分解图示出了可用衬圈组件426实现这一点的接头的示例。外部保持架410的近侧端部413可具有外接细长轴6的管状衬圈427。内部主体310的近侧端部312可具有如上所述骑在细长轴6上的部分周向内衬圈328。可从外径324小于外部保持架410的管状衬圈427的内径428的海波管切割出部分周向内衬圈328。此类构型可允许内衬圈328位于管状外衬圈427的径向内侧,使得内部主体310或外部保持架410中的任一者可以相对于另一者少量旋转。部分周向设置还允许将内衬圈328与完全周向外衬圈427一起组装在轴6上。
内部主体310的部分内衬圈328和外部保持架410的外衬圈427的同轴衬圈组件426可允许两个主体在脉管系统内弯曲期间与装置300的中性轴线基本上对齐。由衬圈组件426允许的外部保持架410和内部主体310之间的旋转可能性还可帮助防止凝块剪切,原本可能通过静态且固定的连接发生凝块剪切。
图11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11中概述的方法11000,步骤11010可涉及跨未知组成的目标凝块递送凝块取回装置。凝块可以是紧实且富含纤维蛋白的,柔软且易碎的,或两者的一些组合。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。
撑条的可膨胀元件可附接到细长轴的远侧端部,并且使外部保持架单元和内部主体单元位于外部保持架的管腔内。步骤11020可涉及通过使装置从受限的递送构型膨胀到膨胀部署构型,将外部保持架的单元中的至少一个单元和内部主体的单元中的至少一个单元嵌入凝块中。来自外部保持架的膨胀的径向力可导致凝块的至少一部分径向向内迁移。
在步骤11030中,可朝远侧推进微导管或其他外部导管以与内部主体和外部保持架的单元中的至少一些单元接合,从而夹紧压缩凝块的至少紧实部分。内部主体和/或外部保持架的单元可被成形为在轴向顶点处具有弯曲部,其被成形为随着装置被部分地重新套入而径向向下折叠单元。鞍点可因此对凝块组成中任何富含纤维蛋白的芯施加牢固的夹持。
外部导管的远侧推进可继续,直到使用者感觉到阻力,这表明已实现夹紧,或者未感觉到阻力,这表明凝块不含富含纤维蛋白的部分。如果未实现夹紧,则步骤11040可涉及撤回外部导管以将装置重新部署并嵌入凝块中。该重新部署使装置的单元内的柔软凝块稳定。
在步骤11050中,外部保持架的撑条中的一些或全部可朝近侧倒置,以折回到凝块和内部主体上方并将凝块和内部主体倒置于内部。倒置可保护凝块并减少由于脉管系统中的摩擦、分叉和/或急剧弯曲引起的可能的相互作用或荒磨。使用者可利用回缩并穿过装置轴的内部管腔的牵拉线或通过其他合适的装置朝近侧牵拉撑条。例如,牵拉线可延伸穿过海波管装置轴并且从定位在轴的近侧端部上的柄部致动。此外,内部主体、外部保持架和细长轴的近侧接头可被构造成允许它们之间的一些相对运动,从而减小回缩力和凝块剪切的风险。
步骤11060可涉及从患者体内移除凝块取回装置和捕获的凝块。这可例如通过借助于抽吸将装置取回到外部导管中来实现。如果实现夹紧,则可通过在撤回期间保持装置和外部导管的相对位置来保持夹紧。如果需要,可将装置在盐水中冲洗并轻柔地清洁,然后在存在闭塞性凝块的另外节段或者在需要进一步通过以进行再通时重新加载到微导管中以重新引入脉管系统中。
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:
近侧管状轴,所述近侧管状轴包括延伸穿过其的管腔;
撑条框架,所述撑条框架具有受限的递送构型、膨胀凝块接合部署构型和至少部分受限的凝块夹紧构型,所述撑条框架包括:
细长内部主体,所述细长内部主体包括远侧端部、纵向轴线和一个或多个凝块夹紧单元,所述一个或多个凝块夹紧单元被构造成在从所述部署构型运动到所述凝块夹紧构型时夹紧所述凝块;
外部保持架,所述外部保持架连接到所述细长内部主体的所述远侧端部并且能够膨胀到大于所述细长内部主体的径向范围;以及
一根或多根牵拉线,所述一根或多根牵拉线延伸穿过所述近侧管状轴的所述管腔并且固定地连接到所述外部保持架,所述牵拉线被构造成将所述外部保持架从膨胀部署构型运动到倒置凝块外壳构型。
2.根据权利要求1所述的装置,所述内部主体和所述外部保持架通过激光切割单个连续管而一体地形成。
3.根据权利要求1所述的装置,每个夹紧单元包括位于所述单元的所述近侧端部和所述远侧端部处的马蹄形鞍点。
4.根据权利要求1所述的装置,所述牵拉线在连接点处通过压接夹具、焊接件或编织物中的至少一者连接到所述外部保持架。
5.根据权利要求1所述的装置,所述外部保持架的所述撑条被构造成在所述外部保持架从所述膨胀部署构型运动到所述倒置凝块外壳构型时朝近侧倒置。
6.根据权利要求5所述的装置,所述外部保持架的所述撑条以所述倒置凝块外壳构型包封所述凝块和所述细长内部主体。
7.根据权利要求1所述的装置,所述近侧管状轴具有小于或等于0.021英寸的外径。
8.根据权利要求1所述的装置,所述细长内部主体在所述膨胀部署构型中具有约2.25mm的外径。
9.根据权利要求1所述的装置,所述外部保持架在所述倒置凝块外壳构型中具有约5mm的外径。
10.一种用于从血管中移除紧实凝块和柔软凝块两者的凝块取回装置,包括:
纵向轴线;
近侧轴;
受限的递送构型、膨胀部署构型和至少部分受限的凝块夹紧构型;
内部主体,所述内部主体包括形成一系列凝块接收单元的撑条,在所述膨胀部署构型中,所述单元沿所述纵向轴线以大致正弦波图案延伸;
外部保持架,所述外部保持架包括一系列节段,每个节段包括被构造成在从所述部署构型运动到所述凝块夹紧构型时夹紧所述凝块的两个单元;以及
锥形撑条网片,所述锥形撑条网片连接到所述外部保持架的所述远侧端部,所述撑条网片包括闭合端部并且被构造为凝块碎片的阻隔件。
11.根据权利要求10所述的装置,所述外部保持架的每个单元包括位于所述单元的所述近侧端部和所述远侧端部处的马蹄形鞍点,所述鞍点被构造成随着所述装置运动到所述凝块夹紧构型而压缩并夹紧所述凝块的至少一部分。
12.根据权利要求10所述的装置,所述内部主体在所述膨胀部署构型中具有1.25mm至1.5mm范围内的外径。
13.根据权利要求10所述的装置,所述外部保持架在所述膨胀部署构型中具有约5mm的外径。
14.根据权利要求10所述的装置,所述凝块夹紧构型通过以下方式实现:在所述内部主体的所述近侧端部和所述外部保持架的所述近侧端部上方推进导管,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外部保持架的所述撑条的至少一部分之间。
15.根据权利要求10所述的装置,所述外部保持架的所述节段通过柔性连接撑条以铰接方式接合到相邻节段,所述连接撑条是相应节段之间的唯一接触点。
16.根据权利要求10所述的装置,所述内部主体的所述单元包括被构造成嵌入并稳定所述凝块的至少一部分的至少一个弯曲部。
17.根据权利要求10所述的装置,所述外部保持架的所述近侧端部包括管状外衬圈。
18.根据权利要求17所述的装置,所述内部主体通过激光切割外径小于所述外部保持架的所述外衬圈的内径的管而一体地形成。
19.一种用于移除紧实凝块和柔软凝块两者的方法,所述方法包括以下步骤:
将具有受限的递送构型、膨胀部署构型和至少部分受限的凝块夹紧构型的凝块取回装置递送到具有凝块的血管,所述凝块取回装置包括:
内部主体,所述内部主体通过激光切割管而一体地形成,所述内部主体包括形成被构造成嵌入凝块的至少一部分的单元的撑条;以及
外部保持架,所述外部保持架沿纵向轴线延伸并且包括能够膨胀到大于所述内部主体的径向范围,所述外部保持架包括形成被构造成嵌入凝块的至少一部分的单元的撑条;
通过使所述装置从所述受限的递送构型膨胀到所述膨胀部署构型,将所述外部保持架的所述单元中的至少一个单元和所述内部主体的所述单元中的至少一个单元嵌入凝块中;
推进外部导管,使得所述外部导管与所述内部主体和所述外部保持架接合,以利用所述内部主体的所述单元和所述外部保持架的所述单元夹紧压缩所述凝块的至少紧实部分;
如果未实现夹紧,则撤回所述外部导管以将所述凝块取回装置重新部署并嵌入柔软凝块中;以及
从患者体内移除所述凝块取回装置和捕获的凝块。
20.根据权利要求19所述的方法,还包括将所述外部保持架的所述撑条朝近侧倒置以将所述凝块和所述内部主体置于内部的步骤。
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EP4023173A1 (en) | 2022-07-06 |
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