CN111743592A - 动脉瘤治疗装置 - Google Patents
动脉瘤治疗装置 Download PDFInfo
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Abstract
本发明公开了一种具有细长部分和可展开编织袋部分的植入物,该植入物可通过导管递送并植入动脉瘤中,使得细长部分在编织袋内形成环,编织袋接触动脉瘤壁的大部分或全部,并且编织袋至少部分地闭塞动脉瘤颈部。
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入口。相比于利用栓塞性线圈填充的动脉瘤块,通过利用栓塞性线圈治疗动脉瘤的入口而形成的自然形成的血栓块可改善愈合,这归因于可降低从动脉壁的可能扩张并且允许沿颈部平面重新结合到原始母血管形状内。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;同时,如果入口未被充分填充,则血流可持续进入动脉瘤内。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、流动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已公开于美国专利公布号20180242979中,该文献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。通常,在本文的示例中,具有细长部分和可展开编织袋部分的植入物可通过导管递送并植入动脉瘤中,使得细长部分在编织袋内形成环并且编织袋至少部分地闭塞动脉瘤颈部。
示例性植入物可包括可展开编织袋部分、接合到编织袋部分的细长环状部分以及接合到细长环状部分的脱离特征部。植入物可从递送构型移动到植入构型。在递送构型中,植入物的尺寸可适于通过导管的内腔递送至治疗部位,并且在植入构型中,植入物的尺寸可适于固定在动脉瘤内。在递送构型中,可展开编织袋部分可从植入物的远侧端部延伸,细长环状部分可从可展开编织袋部分朝近侧延伸,脱离特征部可定位在植入物的近侧端部附近,并且脱离特征部可拆卸地附接到递送系统。
当植入物处于递送构型时、处于植入构型时以及在治疗动脉瘤期间从递送构型转变到植入构型的整个过程中,可展开编织袋部分可不附接到递送系统。在植入构型中,可展开编织袋部分的尺寸可适于接触动脉瘤的内壁的大部分,可容纳细长环状部分,并且可闭塞动脉瘤颈部的开口的一部分或全部。可展开编织袋部分可具有自由端,并且在植入构型中,自由开口端可定位在动脉瘤颈部处。在植入构型中,细长环状部分可在可展开编织袋部分内卷绕。
在递送构型中,植入物可在其远侧端部处具有折叠部,可展开编织袋部分可包围细长环状部分的一部分,并且可展开编织袋部分的自由开口端可环绕细长环状部分。在植入构型中,折叠部可限定细长环状部分与可展开编织袋部分之间的边界,并且折叠部可沿着动脉瘤内壁的远侧表面定位。在递送构型中的植入物远侧端部处的折叠部可为在植入构型中沿动脉瘤壁的远侧表面定位的同一折叠部。
另选地,在递送构型中,自由开口端可定位在植入物的远侧端部处,并且植入物可从植入物的远侧端部处的自由开口端延伸到植入物的近侧端部处的脱离特征部。当这样构造的植入物离开导管并且编织袋部分进入动脉瘤时,可形成折叠部,并且折叠部可沿动脉瘤内壁的远侧表面定位。
细长环状部分和可展开编织袋部分都可为连续的管状编织物的部分。折叠部可限定细长环状部分与可展开编织袋部分之间的边界,并且细长环状部分可具有从折叠部到脱离特征部可测量的长度。连续的管状编织物的细长环状部分可沿其长度的大部分具有基本上均匀的周长。
另选地,细长环状部分可具有栓塞性线圈,并且可展开编织袋部分可为管状编织物。
当植入物在动脉瘤治疗完成时被植入并留在动脉瘤中时,植入物可仅包括袋部分、细长环状部分和脱离特征部。植入物不需要具有任何其它特征部,诸如附加的脱离特征部或锚固元件。
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,并且该方法可包括此处未包括的附加步骤。可提供具有可展开部分和栓塞卷绕部分的植入物。栓塞卷绕部分能够可拆卸地附接到递送系统。植入物可定位在微导管内,使得栓塞卷绕部分从植入物的近侧端部朝远侧延伸,可展开部分从植入物的远侧端部朝近侧延伸,并且可展开部分不附接到递送系统。微导管的远侧端部可定位在动脉瘤颈部附近。可通过微导管将植入物递送至微导管的远侧端部。可展开部分可从微导管的远侧端部排出。可展开部分可展开以接触动脉瘤的内壁的大部分。栓塞卷绕部分可从微导管的远侧端部排出。可将栓塞卷绕部分放置成卷绕在展开的可展开部分内。栓塞卷绕部分可从递送系统脱离。
当植入物定位在微导管中时,可将折叠部定位在植入物的远侧端部处,并且可将可展开部分定位成包围栓塞卷绕部分的至少一部分。另选地,当植入物定位在微导管中时,可将植入物的自由开口端定位在植入物的远侧端部处。
可将可展开部分锚固到动脉瘤的内壁,并且可将可展开部分放置成禁止栓塞卷绕部分离开动脉瘤的囊。可展开部分可具有自由开口端,并且自由开口端可定位在动脉瘤颈部处。可将植入物折叠以形成限定可展开部分与栓塞卷绕部分之间的边界的折叠部。折叠部可定位在动脉瘤内壁的远侧表面附近。
当提供具有可展开部分和栓塞部分的植入物时,可提供连续的管状编织物,并且可展开部分和栓塞部分可为连续的管状编织物的部分。当将连续的编织物的栓塞卷绕部分放置成在展开的可展开部分内卷绕时,可沿栓塞卷绕部分的长度的大部分保持基本上均匀的周长。另选地,当提供具有可展开部分和栓塞部分的植入物时,可提供接合栓塞性线圈的管状编织物,使得管状编织物包括可展开部分并且栓塞性线圈包括栓塞部分。
可提供脱离特征部并将其附连到栓塞卷绕部分。脱离特征部能够可拆卸地附接到递送系统。为了将可展开部分、栓塞卷绕部分和脱离特征部植入动脉瘤中,可使脱离特征部从递送系统脱离。当脱离特征部脱离时,仅可展开部分、栓塞卷绕部分和脱离特征部可在植入物中保持植入状态。
治疗动脉瘤的另一个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,并且该方法可包括此处未包括的附加步骤。可提供具有编织部分和栓塞部分的植入物。编织部分可包括形状记忆材料并且可具有为球形或球状的预定形状。栓塞部分能够可拆卸地附接到植入物递送系统。植入物和递送系统可定位在微导管的内腔内。当植入物和递送系统定位在微导管中时,编织部分可塌缩以适配在内腔中并定位在内腔中以从植入物的远侧端部朝近侧延伸,可将栓塞部分定位成从植入物的近侧端部朝远侧延伸,并且可将递送系统定位成从栓塞部分朝近侧延伸。在编织部分未附接到递送系统时,植入物和递送系统可横穿微导管的内腔。植入物可从微导管排出。当植入物被排出时,编织部分可从微导管排出并展开以形成基于球形预定形状的袋形状,栓塞部分可从微导管排出并卷绕在编织部分的袋形状内。当植入物被排出时,可定位在编织部分的袋形状中的开口可定位在动脉瘤颈部附近,折叠部可定位成限定编织部分与动脉瘤壁的远侧表面附近的栓塞部分之间的边界,并且栓塞部分可横穿袋形状中的开口。
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,类似的编号指示各种图中类似的结构元件和特征。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1A至1C是根据本发明的各方面的处于塌缩或递送构型的示例性植入物(图1A)、图1A所示塌缩的植入物的横截面(图1C)以及处于植入或展开构型的示例性植入物(图1B)的图示;
图2A至2E是根据本发明的各方面的示例性植入物在植入步骤期间的图示;
图3A和3B是根据本发明的各方面的处于塌缩或递送构型的示例性植入物(图3A)以及处于植入或展开构型的示例性植入物(图3B)的图示;
图4A和4B是根据本发明的各方面的处于塌缩或递送构型的示例性植入物(图4A)以及处于植入或展开构型的示例性植入物(图4B)的图示;
图5A至5E是根据本发明的各方面的示例性植入物在植入步骤期间的图示;
图6A和6B是根据本发明的各方面的处于塌缩或递送构型的示例性植入物(图6A)以及处于植入或展开构型的示例性植入物(图6B)的图示;并且
图7至图10是概述根据本发明的各方面的用于治疗动脉瘤的示例性方法步骤的流程图。
具体实施方式
本发明的目的是提供一种适用于对患者的动脉瘤进行血管内治疗的栓塞性植入物。该植入物可具有在递送至治疗部位时可重新成形的两个部分。
图1A示出了处于塌缩或递送构型的示例性植入物200。在递送构型中,植入物200的尺寸可适于通过插入患者脉管系统的导管递送至治疗部位。图1C示出了如图1A所示的塌缩的植入物200的剖视图。图1B示出了图1A所示的示例性植入物200处于展开或植入构型。在植入构型中,植入物200可定位在动脉瘤10的囊12中,以使来自动脉瘤10的颈部16的血流转向,并用栓塞性材料填充囊12。动脉瘤囊12中的栓塞性材料可促进动脉瘤10中的血栓团块的形成,并且来自动脉瘤颈部16的血流的转向可引起动脉瘤中的静脉淤滞并降低动脉瘤治疗手术后动脉瘤再通的可能性。
共同参考图1A至1C,植入物100可包括细长部分204、可展开袋部分202和脱离特征部230。细长部分204和可展开袋部分202可各自为编织的。可展开袋部分202和细长部分204可被制造成两个单独的结构或一个连续的编织结构。编织部分可由编织的镍钛诺、钴、铬、塑料或其它合适的材料制成。植入物200的部分可由具有预定形状和变形形状的记忆形状材料制成。记忆形状材料在植入物200处于递送构型时可呈变形形状,并且在植入物200处于展开或植入构型时可朝向预定形状移动。当被植入时,记忆形状材料可受到解剖结构几何形状的限制,并且记忆形状材料可采取接近预定形状但由于解剖结构限制而不匹配预定形状的形状。
脱离特征部230可接合到细长部分204,并且当植入物200通过导管递送至治疗部位时,脱离特征部230能够可拆卸地附接到递送系统。
参见图1A,在递送构型中,脱离特征部230可定位在植入物200的近侧端部212处,细长部分204可从脱离特征部230朝远侧延伸至定位在植入物200的远侧端部214处的折叠部203,并且可展开编织袋部分202可从折叠部203朝近侧延伸。在递送构型中,可展开编织袋部分202可从折叠部203朝远侧延伸以包裹细长部分204的长度L的一部分,并且可展开编织袋部分202可具有环绕细长部分204的开口端226。开口端226优选地为无任何辅助附件的编织物的开口端。当植入物200通过导管递送至治疗部位或当植入物200被部署在动脉瘤内时,开口端226无需附接到递送系统。编织物210在开口端226处的股线可为自由的切割端;或者另选地,开口端226处的股线可为闭合的,这意味着开口端处的编织物内的股线通过胶接、焊接等彼此附接,或者股线在开口端处折弯。自由的切割端可具有更容易制造的优点,而闭合端可具有比切割端更好地防止损伤的优点。
参见图1A和1B,植入物200可包括形状记忆材料并且可为预成形的,使得可展开编织袋部分202形成球状或球形形状,并且折叠部203将细长环状部分204与可展开编织袋部分202分隔开。可将形状记忆材料热定型为预定形状。球形形状、折叠部203和细长部分的线圈可通过热定型来成形。图1B所示的植入形状可基于预定形状和动脉瘤10的内壁14的形状。为了使植入物从预定形状塌缩以便其能够通过导管递送,可延伸并拉直细长环状部分204,并且可围绕细长环状部分204压缩袋部分202。当植入物200处于递送构型时,可进一步折叠在预成形植入物时形成的折叠部,以限定袋部分202与细长环状部分204之间的边界。
参见图1B,在植入构型中,可展开编织袋部分202可展开以接触动脉瘤10的内壁14的大部分。折叠部203可定位在动脉瘤壁14的远侧表面15附近。细长部分204可在动脉瘤囊12内和编织袋部分202内卷绕。通过锚固在囊12内,可展开编织袋部分202可保持植入物200在动脉瘤10中的恰当定位,并且防止植入物200的部分诸如细长部分204延伸到血管20a、20b、21中或离开动脉瘤囊12。
可展开编织袋部分202的自由开口端226可在植入物处于植入构型或预成形构型时限定袋中的开口,并且当植入后,开口可定位在动脉瘤颈部16附近。开口的尺寸可被设定成使得可展开编织袋部分202的一部分横跨动脉瘤颈部16以闭塞颈部。细长部分204可通过开口进入动脉瘤囊12和可展开编织袋部分202的袋中。细长部分204可在可展开编织袋部分202内和动脉瘤囊12内以复杂盘绕形状卷绕或形成环。细长环状部分204可抵靠编织袋202按压,并且抵靠编织袋202的内表面提供力以将编织袋202的外表面按压到动脉瘤壁14,以进一步将编织袋202锚固在动脉瘤囊12内。
环状细长部分204可填充动脉瘤囊12的大部分。植入的编织袋202可为编织网,其具有尺寸适于抑制血流进入动脉瘤10中的孔隙率。细长部分可沿其长度L的大部分或全部具有基本上均匀的周长206,并且其可在其从递送构型移动至植入构型时保持该基本上均匀的周长206。
图2A至2E是示例性植入物在植入步骤期间的图示。图2A示出了定位在靠近动脉瘤10的导管600内的植入物200。动脉瘤10被示出为定位在分叉血管中,该分叉血管具有主干血管21、第一侧分支血管20a和第二侧血管20b。导管600可从主干血管21接近动脉瘤10。设想本文所公开的示例性植入物200可用于根据本文所述的方法治疗侧壁血管,如本领域的普通技术人员将会理解的那样。在图2A所示的情况下,植入物200在导管600中塌缩。植入物200可包括记忆形状材料,其在导管600中塌缩时呈变形形状。
图2B示出了植入期间的植入物200。植入物200可包括可展开编织袋部分202和细长栓塞部分204。随着植入物200朝远侧平移穿过导管600,折叠部203可定位在植入物200的远侧端部214处,并且可展开编织袋部分202和细长环状部分204可从折叠部203朝近侧延伸。如此构造时,编织袋部分202可在导管600中取向,使得朝远侧将植入物200推出导管600时,编织袋部分202被推出导管600并进入囊12中,之后细长环状部分204的大部分开始离开导管600。
图2C示出了植入物200在编织袋部分202已离开导管600并在动脉瘤12内展开之后的情况。编织袋部分202可展开以接触动脉瘤10的内壁14的全部或大部分。编织袋202可在离开导管600时朝预定形状展开。与温暖的体液接触可导致编织袋202中的形状记忆材料移动到预定形状。自由开口端226可限定编织袋202中的开口,并且开口可定位在动脉瘤颈部16处。
限定展开的编织袋202与细长部分204之间的边界的折叠部203可定位在动脉瘤壁14的远侧表面15附近。在图2C所示的植入阶段,细长部分204可从折叠部203延伸出,穿过编织袋202中的开口并进入导管600中。
图2D示出了离开导管600、穿过自由开口端226进入编织袋部分202并卷绕在袋202内的细长部分204。随着细长部分204离开导管600,细长部分204可在其离开导管600时保持其周长206。细长部分204可响应于接触展开的编织袋202的内表面而在动脉瘤囊12内卷绕或形成环。除此之外或另选地,细长部分204可包括具有预定形状和变形形状的形状记忆材料。预定形状可为复杂环状形状,并且变形形状可为基本上直的。由于细长部分204在其离开导管600时接触血液,细长部分204可响应于记忆形状材料从变形形状朝预定形状移动而在动脉瘤囊12内卷绕或形成环。除此之外或另选地,细长部分204可包括柔性可弹性变形材料,该材料具有为环状形状的松弛形状。柔性可弹性变形材料可在递送穿过导管期间退绕成基本上直的股线,并且可在离开导管12时塌缩成环状形状。
在图2D所示的情况下,脱离特征部230可保持附接到递送系统。当植入物200附接到递送系统时,可朝近侧牵拉递送系统以撤出植入物200的全部或部分。可随后朝远侧推动递送系统以重新定位植入物200。
图2E示出了处于最终植入构型的植入物200,诸如相对于图1B所述。脱离特征部230可在脱离递送系统之前通过递送系统朝远侧移动,经过动脉瘤16的平面,穿过展开的袋部分202的开口端226,并进入动脉瘤囊12中。细长部分204可具有预定形状,该预定形状被构造成在植入植入物200之后有利于脱离特征部230移动经过动脉瘤颈部16的平面。除此之外或另选地,可操纵递送系统以将脱离特征部230放置在袋部分202内。植入物200被植入之后,如图2E所示,递送系统可脱离并撤出,并且可从患者移动或提取微导管600。
开口端226可在植入完成时保持打开,并且细长部分204在固定在袋202内之后可被卷绕在由开口端226限定的开口附近,从而阻止血流进入开口。换句话讲,袋202可围绕颈部周边闭塞颈部16的一部分,并且细长部分204可在由开口端226限定的袋202中的开口处闭塞颈部16。
图3A示出了处于塌缩或递送构型的示例性植入物200a。在递送构型中,植入物200a可塌缩至可通过插入患者脉管系统中的导管递送至治疗部位的尺寸。图3B示出了图3A所示的示例性植入物200a处于展开或植入构型。在植入构型中,植入物200a可定位在动脉瘤10的囊12中,以使来自动脉瘤10的颈部16的血流转向,并用栓塞性材料填充囊12。动脉瘤囊12中的栓塞性材料可促进动脉瘤10中的血栓团块的形成,并且来自动脉瘤颈部16的血流的转向可引起动脉瘤中的静脉淤滞并降低动脉瘤治疗手术后动脉瘤再通的可能性。
将图3A和3B所示的示例性植入物200a与图1A至2E所示的植入物200进行比较,图3A和3B中植入物200a的细长部分204a可为栓塞性线圈204a而不是如图1A至2E所示的编织物204。图3A和3B所示的植入物200a可按照类似于图2A至2E所示的过程植入。
共同参考图3A和3B,植入物200a可包括栓塞性线圈204a、可展开编织袋部分202a、脱离特征部230a以及将栓塞性线圈204a接合到可展开编织物202a的连接带222。连接带222可包括射线不可透过的材料,以有利于在X射线下看见植入物200a。可展开编织袋部分202a可为编织的。植入物200a的部分(包括栓塞性线圈204a)可由具有预定形状和变形形状的记忆形状材料制成。记忆形状材料在植入物200a处于递送构型时可呈变形形状,并且在植入物200a处于展开或植入构型时可朝向预定形状移动。当被展开或植入时,记忆形状材料可受到解剖结构几何形状的限制,并且记忆形状材料可采取接近预定形状但由于解剖结构限制而不匹配预定形状的形状。
脱离特征部230a可接合到细长部分204a,并且当植入物200a通过导管递送至治疗部位时,脱离特征部230a能够可拆卸地附接到递送系统。
参见图3A,在递送构型中,脱离特征部230a可定位在植入物200a的近侧端部212a处,细长部分204可从脱离特征部230a朝远侧延伸至连接带222,编织部分202a可具有定位在植入物200a的远侧端部214a处的折叠部203a,并且可展开编织袋部分202a可从折叠部203a朝近侧延伸。在递送构型中,可展开编织袋部分202a可从折叠部203a朝远侧延伸以包裹栓塞性线圈204a的长度L'的一部分,并且可展开编织袋部分202a可具有环绕栓塞性线圈204a的自由开口端226a。编织部分202a在开口端226a处的股线可为自由的切割端;或者另选地,开口端226a处的股线可为闭合的,这意味着自由开口端226a处的编织物内的股线通过胶接、焊接等彼此附接,或者股线在开口端226a处折弯。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。
参见图3A和3B,植入物200a可包括形状记忆材料并且可为预成形的,使得可展开编织袋部分202a形成球状或球形形状,并且编织物可具有位于连接带222附近的折叠部203a。可将形状记忆材料热定型为预定形状。图3B所示的植入形状可基于预定形状和动脉瘤10的内壁14的形状。为了使植入物从预定形状塌缩以便其能够通过导管递送,可延伸并拉直栓塞性线圈204a,并且可围绕细长环状部分204a压缩袋部分202a。当植入物200a处于递送构型时,可将在预成形植入物时形成的折叠部进一步折叠并定位植入物200a的远侧端部214a处。
参见图3B,在植入构型中,可展开编织袋部分202a可展开以接触动脉瘤10的内壁14的大部分。折叠部203a可定位在动脉瘤壁14的远侧表面15附近。栓塞性线圈204a可在动脉瘤囊12内和编织袋部分202a内卷绕。通过锚固在囊12内,可展开编织袋部分202a可保持植入物200a在动脉瘤10中的恰当定位,并且防止植入物200a的部分诸如栓塞性线圈204a延伸到血管20a、20b、21中或离开动脉瘤囊12。
可展开编织袋部分202a的自由端226a可在植入物200a处于植入构型或预成形构型时限定袋中的开口,并且当植入后,开口可定位在动脉瘤颈部16附近。开口的尺寸可被设定成使得可展开编织袋部分202a的一部分横跨动脉瘤颈部16以闭塞颈部。栓塞性线圈204a可通过开口进入动脉瘤囊12和可展开编织袋部分202a的袋中。细长部分204a可在可展开编织袋部分202a内和动脉瘤囊12内以复杂盘绕形状卷绕或形成环。细长环状部分204a可抵靠编织袋202a按压,并且抵靠编织袋202a的内表面提供力以将编织袋202a的外表面按压到动脉瘤壁14,以进一步将编织袋202a锚固在动脉瘤囊12内。
环状栓塞性线圈204a可填充动脉瘤囊12的大部分。植入的编织袋202a可为编织网,其具有尺寸适于抑制血流进入动脉瘤10中的孔隙率。
作为使处于递送构型的植入物成形以使得可展开编织袋部分202,202a包封细长部分204,204a的替代方案,如图1A和3A所示,植入物可在处于递送构型时伸长,如图4A和6A所示的那样。图1A和1B所示的植入物200与图4A和4B所示的植入物300相比,可具有基本上相同的预定形状和/或植入构型。同样,图3A和3B所示的植入物200a与图6A和6B所示的植入物300a相比,可具有基本上相同的预定形状和/或植入构型。
比较图1B和4B,由连续的管状编织物210,310形成的植入物200,300在植入后可能无法分辨。同样,比较图3B和6B,由编织部分202a,302a和栓塞性线圈204a,304a形成的植入物200a,300a在植入后可能无法分辨。图1A至3B所示的植入物200,200a与图4A至6B所示的植入物300,300a之间的显著差异包括:处于每个相应的变形形状时存在或是缺失折叠部203,203a,自由开口端226,226a,314,314a在递送期间的定位,以及在治疗期间在动脉瘤10内展开可展开编织部分202,202a,302,302a的过程。
参见图4A和4B,植入物300可包括连续的管状编织物310和脱离特征部330。如图4A所示,在递送构型中,脱离特征部330可定位在植入物300的近侧端部312处,细长部分304可从脱离特征部330朝远侧延伸,可展开编织袋部分302可从细长部分304朝远侧延伸,并且可展开编织袋部分302可具有定位在植入物300的远侧端部314处的自由开口端。在递送构型中,植入物300无需具有任何可辨别的边界来指示管状编织物310的哪个部分是细长环状部分304,哪个部分是可展开袋部分302。开口端314处的股线可为自由的切割端;或者另选地,开口端314处的股线可为闭合的,这意味着自由开口端314处的编织物内的股线通过胶接、焊接等彼此附接,或者股线在开口端314处折弯。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。
植入物300可包括形状记忆材料并且可为预成形的,使得可展开编织袋部分302形成球状或球形形状,并且折叠部303将细长环状部分304与可展开编织袋部分302分隔开。可将形状记忆材料热定型为预定形状。图4B所示的植入形状可基于预定形状和动脉瘤10的内壁14的形状。为了将植入物300从预定形状(类似于图4B所示的植入构型)塌缩至变形形状(诸如图4A所示的那样)以使得其可通过导管递送,可展开并拉直细长环状部分304,可反转并拉伸袋部分302,并且可打开并平整折叠部303。
参见图4B,在植入构型中,可展开编织袋部分302可展开以接触动脉瘤10的内壁14的大部分。折叠部303可定位在动脉瘤壁14的远侧表面15附近。细长部分304可在动脉瘤囊12内和编织袋部分302内卷绕。通过锚固在囊12内,可展开编织袋部分302可保持植入物300在动脉瘤10中的恰当定位,并且防止植入物300的部分诸如细长部分304延伸到血管20a、20b、21中或离开动脉瘤囊12。
可展开编织袋部分302的自由端314可在植入物处于植入构型或预成形构型时限定袋中的开口,并且当植入后,开口可定位在动脉瘤颈部16附近。开口的尺寸可被设定成使得可展开编织袋部分302的一部分横跨动脉瘤颈部16以闭塞颈部。细长部分304可通过开口进入动脉瘤囊12和可展开编织袋部分302的袋中。细长部分304可在可展开编织袋部分302内和动脉瘤囊12内以复杂盘绕形状卷绕或形成环。细长环状部分304可抵靠编织袋302按压,并且抵靠编织袋302的内表面提供力以将编织袋302的外表面按压到动脉瘤壁14,以进一步将编织袋302锚固在动脉瘤囊12内。
环状细长部分304可填充动脉瘤囊12的大部分。植入的编织袋302可为编织网,其具有尺寸适于抑制血流进入动脉瘤10中的孔隙率。细长部分可沿其长度的大部分或全部具有基本上均匀的周长306,并且其可在其从递送构型移动至植入构型时保持该基本上均匀的周长306。
图5A至5E是示例性植入物300在植入步骤期间的图示。图5A示出了定位在靠近动脉瘤10的导管600内的植入物300。动脉瘤10被示出为定位在分叉血管中,该分叉血管具有主干血管21、第一侧分支血管20a和第二侧血管20b。导管600可从主干血管21接近动脉瘤10。设想本文所公开的示例性植入物300可用于根据本文所述的方法治疗侧壁血管,如本领域的普通技术人员将会理解的那样。在图5A所示的情况下,植入物300在导管600中塌缩。植入物300可包括记忆形状材料,其在导管600中塌缩时呈变形形状。
图5B示出了植入期间的植入物300。植入物300可包括可展开编织袋部分302和细长栓塞部分304。随着植入物300朝远侧平移穿过导管600,可展开编织袋部分302的自由开口端314可定位在植入物300的远侧端部314处,可展开部分302可从其自由开口端314朝近侧延伸,并且细长栓塞性或环状部分304可从可展开部分302朝近侧延伸。如此构造时,可展开部分302可在细长部分304开始离开导管600之前被完全排出导管600。
如图5B所示,可展开编织袋部分302可在离开导管600之后开始反转。自由开口端314可环绕编织物310,并且编织物310的部分可平移穿过自由开口端314的开口。植入物300的自由端314无需附接到递送系统来使编织袋部分302反转。反转可以是编织袋部分302朝向其预定形状移动的结果。
图5C示出了植入物300在编织袋部分302已离开导管600并在动脉瘤12内展开之后的情况。编织袋部分302可展开以接触动脉瘤10的内壁14的全部或大部分。编织袋302可在离开导管600时朝预定形状展开。与温暖的体液接触可导致编织袋302中的形状记忆材料移动到预定形状。自由开口端314可限定编织袋302中的开口,并且开口可定位在动脉瘤颈部16处。
当植入物303处于植入构型时限定展开的编织袋302与细长部分304之间的边界的折叠部300可定位在动脉瘤壁14的远侧表面15附近。在图5C所示的植入阶段,细长部分304可从折叠部303延伸出,穿过编织袋302中的开口并进入导管600中。
图5D示出了离开导管600、穿过自由开口端314进入编织袋部分302并卷绕在袋302内的细长部分304。随着细长部分304离开导管600,细长部分304可在其离开导管600时保持其周长306。细长部分304可响应于接触展开的编织袋302的内表面而在动脉瘤囊12内卷绕或形成环。除此之外或另选地,细长部分304可包括具有预定形状和变形形状的形状记忆材料。预定形状可为复杂环状形状,并且变形形状可为基本上直的。由于细长部分304在其离开导管600时接触血液,细长部分304可响应于记忆形状材料从变形形状朝预定形状移动而在动脉瘤囊12内卷绕或形成环。除此之外或另选地,细长部分304可包括柔性可弹性变形材料,该材料具有为环状形状的松弛形状。柔性可弹性变形材料可在递送穿过导管期间退绕成基本上直的股线,并且可在离开导管12时塌缩成环状形状。
在图5D所示的情况下,脱离特征部330可保持附接到递送系统。当植入物300附接到递送系统时,可朝近侧牵拉递送系统以撤出植入物300的全部或部分。可随后朝远侧推动递送系统以重新定位植入物300。
图5E示出了处于最终植入构型的植入物300,诸如相对于图4B所述。脱离特征部330可在脱离递送系统之前通过递送系统朝远侧移动,经过动脉瘤16的平面,穿过展开的袋部分302的开口端314,并进入动脉瘤囊12中。细长部分304可具有预定形状,该预定形状被构造成在植入植入物300之后有利于脱离特征部314移动经过动脉瘤颈部16的平面。除此之外或另选地,可操纵递送系统以将脱离特征部314放置在袋部分302内。植入物300被植入之后,如图5E所示,递送系统可脱离并撤出,并且可从患者移动或提取微导管600。
开口端314可在植入完成时保持打开,并且细长部分304在固定在袋302内之后可被卷绕在由开口端314限定的开口附近,从而阻止血流进入开口。换句话讲,袋302可围绕颈部周边闭塞颈部16的一部分,并且细长部分304可在由开口端314限定的袋302中的开口处闭塞颈部16。
图6A示出了处于塌缩或递送构型的示例性植入物300a。在递送构型中,植入物300a可塌缩至可通过插入患者脉管系统中的导管递送至治疗部位的尺寸。图6B示出了图6A所示的示例性植入物300a处于展开或植入构型。在植入构型中,植入物300a可定位在动脉瘤10的囊12中,以使来自动脉瘤10的颈部16的血流转向,并用栓塞性材料填充囊12。动脉瘤囊12中的栓塞性材料可促进动脉瘤10中的血栓团块的形成,并且来自动脉瘤颈部16的血流的转向可引起动脉瘤中的静脉淤滞并降低动脉瘤治疗手术后动脉瘤再通的可能性。
将图6A和6B所示的示例性植入物300a与图4A至5E所示的植入物300进行比较,图6A和6B中植入物300a的细长部分304a可为栓塞性线圈304a而不是如图4A至5E所示的编织物304。图6A和6B所示的植入物300a可按照类似于图5A至5E所示的过程植入。
共同参考图6A和6B,植入物300a可包括栓塞性线圈304a、可展开编织袋部分302a、脱离特征部330a以及将栓塞性线圈304a接合到可展开编织物302a的连接带322。可展开编织袋部分302a可为编织的。植入物300a的部分(包括栓塞性线圈304a)可由具有预定形状和变形形状的记忆形状材料制成。记忆形状材料在植入物300a处于递送构型时可呈变形形状,并且在植入物300a处于展开或植入构型时可朝向预定形状移动。当被展开或植入时,记忆形状材料可受到解剖结构几何形状的限制,并且记忆形状材料可采取接近预定形状但由于解剖结构限制而不匹配预定形状的形状。
脱离特征部330a可接合到细长部分304a,并且当植入物300a通过导管递送至治疗部位时,脱离特征部330a能够可拆卸地附接到递送系统。
参见图6A,在递送构型中,脱离特征部330a可定位在植入物300a的近侧端部312a处,细长部分304可从脱离特征部330a朝远侧延伸至连接带322,编织部分302a可从连接带322朝远侧延伸,并且编织部分302a可具有定位在植入物300a的远侧端部处的自由开口端314a。编织部分302a在开口端314a处的股线可为自由的切割端;或者另选地,开口端314a处的股线可为闭合的,这意味着自由开口端314a处的编织物内的股线通过胶接、焊接等彼此附接,或者股线在开口端314a处折弯。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。
参见6A和6B,植入物300a可包括形状记忆材料并且可为预成形的,使得可展开编织袋部分302a形成球状或球形形状,并且编织物可具有位于连接带322附近的折叠部303a。可将形状记忆材料热定型为预定形状。图6B所示的植入形状可基于预定形状和动脉瘤10的内壁14的形状。为了使植入物从预定形状塌缩以便其能够通过导管递送,可延伸并拉直栓塞性线圈304a,可反转并拉伸袋部分302a,并且可打开并平整折叠部303。
参见图6B,在植入构型中,可展开编织袋部分302a可展开以接触动脉瘤10的内壁14的大部分。折叠部303a可定位在动脉瘤壁14的远侧表面15附近。栓塞性线圈304a可在动脉瘤囊12内和编织袋部分302a内卷绕。通过锚固在囊12内,可展开编织袋部分302a可保持植入物300a在动脉瘤10中的恰当定位,并且防止植入物300a的部分诸如栓塞性线圈304a延伸到血管20a、20b、21中或离开动脉瘤囊12。
可展开编织袋部分302a的自由端314a可在植入物300a处于植入构型或预成形构型时限定袋中的开口,并且当植入后,开口可定位在动脉瘤颈部16附近。开口的尺寸可被设定成使得可展开编织袋部分302a的一部分横跨动脉瘤颈部16以闭塞颈部。栓塞性线圈304a可通过开口进入动脉瘤囊12和可展开编织袋部分302a的袋中。细长部分304a可在可展开编织袋部分302a内和动脉瘤囊12内以复杂盘绕形状卷绕或形成环。细长环状部分304a可抵靠编织袋302a按压,并且抵靠编织袋302a的内表面提供力以将编织袋302a的外表面按压到动脉瘤壁14,以进一步将编织袋302a锚固在动脉瘤囊12内。
环状栓塞性线圈304a可填充动脉瘤囊12的大部分。植入的编织袋302a可为编织网,其具有尺寸适于抑制血流进入动脉瘤10中的孔隙率。
图7是示出用于治疗动脉瘤的示例性方法步骤的流程图。该方法步骤可通过本文所述的示例性装置或通过本领域的普通技术人员已知的任何方式来实现。
参见图7所示的方法700,在步骤702中,可提供具有可展开部分和栓塞卷绕部分的植入物。在步骤704中,栓塞卷绕部分能够可拆卸地附接到递送系统。在步骤706中,植入物可定位在微导管内,并且栓塞卷绕部分从植入物的近侧端部朝远侧延伸,可展开部分从植入物的远侧端部朝近侧延伸,并且可展开部分不附接到递送系统。在步骤708中,微导管的远侧端部可定位在动脉瘤颈部附近。在步骤710中,可通过微导管将植入物递送至微导管的远侧端部。在步骤712中,可展开部分可从微导管的远侧端部排出。在步骤714中,可展开部分可展开以接触动脉瘤的内壁的大部分。在步骤716中,栓塞卷绕部分可从微导管的远侧端部排出。在步骤718中,栓塞卷绕部分可被放置成在展开的可展开部分内卷绕。在步骤720中,栓塞卷绕部分可从递送系统脱离。
参见图8所示的方法800,在步骤810中,可提供具有栓塞部分和具有形状记忆材料的编织部分的植入物。在步骤820中,编织部分可被成形为具有球形预定形状。在步骤830中,栓塞部分可附接到植入物递送系统,以便稍后可使其脱离。在步骤840中,植入物和递送系统可定位在微导管内。在步骤850中,在编织部分未附接到递送系统时,植入物和递送系统可横穿微导管。在步骤860中,植入物可从微导管排出。
方法800中将植入物和递送系统定位在微导管中的步骤840可包括如图9所示的子步骤。在子步骤842中,编织部分可塌缩以配合在微导管内。在子步骤844中,编织部分可被定位成从植入物的远侧端部朝近侧延伸。在子步骤846中,栓塞部分可被定位成从植入物的近侧端部朝远侧延伸。在子步骤848中,递送系统可被定位成从栓塞部分朝近侧延伸。
方法800中从微导管排出植入物的步骤860可包括如图10所示的子步骤。在子步骤862中,编织部分可从微导管排出。在子步骤864中,可展开编织部分以形成基于球形预定形状的袋形状。在子步骤866中,栓塞部分可从微导管排出。在子步骤868中,栓塞部分可卷绕在编织部分的袋形状内。
本文所包含的描述为本发明的实施方案的示例,并且不旨在限制本发明的范围。如本文所述,本发明设想到可用于闭塞并填充动脉瘤的植入物、系统或方法的许多变型和修改。变型可包括但不限于例如组合各种实施方案的元件,利用本文所述的元件和部件的另选几何形状,针对每个部件或元件利用另选的材料(例如,射线不可透过的材料、记忆形状材料等),利用附加部件(包括用于将植入物递送至治疗部位处、将植入物定位在治疗部位处、缩回植入物和/或从导管中弹出植入物的一部分的部件),利用附加部件来执行本文所述的功能,以及利用附加部件来执行本文未描述的功能。这些修改对本领域中的普通技术人员将是显而易见的,并且旨在处于以下权利要求的范围内。
Claims (20)
1.一种植入物,包括:
可展开编织袋部分,所述可展开编织袋部分包括自由开口端;
细长环状部分,所述细长环状部分接合到所述可展开编织袋部分;和
脱离特征部,所述脱离特征部接合到所述细长环状部分,
其中所述植入物能够从递送构型移动至植入构型,所述递送构型的尺寸适于横穿导管的内腔,所述植入构型的尺寸适于固定在动脉瘤内,
其中在所述递送构型中,所述可展开编织袋部分从所述植入物的远侧端部延伸,所述细长环状部分从所述可展开编织袋部分朝近侧延伸,并且所述脱离特征部定位在所述植入物的近侧端部附近并可拆卸地附接到递送系统,
其中在所述递送构型中,所述可展开编织袋部分未附接到所述递送系统,
其中在所述植入构型中,所述可展开编织袋部分的尺寸适于接触所述动脉瘤的内壁的大部分、适于容纳所述细长环状部分、并且适于闭塞所述动脉瘤的颈部的至少一部分,
其中在所述植入构型中,所述自由开口端被定位成放置在所述颈部附近,并且
其中在所述植入构型中,所述细长环状部分的尺寸适于卷绕在所述可展开编织袋部分内。
2.根据权利要求1所述的植入物,其中在所述递送构型中,所述植入物包括位于所述植入物的所述远侧端部附近的折叠部,所述可展开编织袋部分围绕所述细长环状部分的至少一部分,并且所述自由开口端环绕所述细长环状部分。
3.根据权利要求1所述的植入物,其中在所述递送构型中,所述自由开口端定位在所述植入物的所述远侧端部处。
4.根据权利要求1所述的植入物,其中在所述植入构型中,限定所述细长环状部分与所述可展开编织袋部分之间的边界的折叠部被定位成在动脉瘤内壁的远侧表面附近被植入。
5.根据权利要求1所述的植入物,其中所述细长环状部分和所述可展开编织袋部分为连续的管状编织物的部分。
6.根据权利要求5所述的植入物,其中在所述植入构型中,所述细长环状部分沿其长度的大部分包括基本上均匀的周长,所述长度可从所述脱离特征部至限定所述细长环状部分与所述可展开编织袋部分之间边界的折叠部测量而得。
7.根据权利要求1所述的植入物,其中所述细长环状部分包括栓塞性线圈,其中所述可展开编织袋部分包括管状编织物。
8.根据权利要求1所述的植入物,其中所述植入物由所述可展开编织袋部分、所述细长环状部分和所述脱离特征部组成。
9.一种用于治疗动脉瘤的方法,包括:
提供包括可展开部分和栓塞卷绕部分的植入物;
将所述栓塞卷绕部分可拆卸地附接到递送系统;
将所述植入物定位在微导管中,使得所述栓塞卷绕部分从所述植入物的近侧端部朝远侧延伸,所述可展开部分从所述植入物的远侧端部朝近侧延伸,并且所述可展开部分不附接到所述递送系统;
将所述微导管的远侧端部定位在动脉瘤颈部附近;
通过所述微导管将所述植入物递送至所述微导管的所述远侧端部;
从所述微导管的所述远侧端部排出所述可展开部分;
展开所述可展开部分以接触所述动脉瘤的内壁的大部分;
从所述微导管的所述远侧端部排出所述栓塞卷绕部分;
将所述栓塞卷绕部分放置成卷绕在所述展开的可展开部分内;以及
使所述栓塞卷绕部分从所述递送系统脱离。
10. 根据权利要求9所述的方法,其中将所述植入物定位在微导管中的步骤还包括:
将折叠部定位在所述植入物的所述远侧端部处,所述可展开部分从所述远侧端部延伸;以及
将所述可展开部分定位成包围所述栓塞卷绕部分的至少一部分。
11.根据权利要求9所述的方法,其中将所述植入物定位在微导管中的步骤还包括:
将所述可展开部分的自由开口端定位在所述植入物的所述远侧端部处。
12. 根据权利要求9所述的方法,还包括:
将所述可展开部分锚固到所述动脉瘤的所述内壁;以及
将所述可展开部分放置成闭塞所述动脉瘤颈部的至少一部分并且抑制所述栓塞卷绕部分离开所述动脉瘤的囊。
13.根据权利要求9所述的方法,其中所述可展开部分包括自由开口端,所述方法还包括:
将所述自由开口端定位在所述动脉瘤颈部处;
折叠所述植入物以形成限定所述可展开部分与所述栓塞卷绕部分之间的边界的折叠部;以及
将所述折叠部定位在所述动脉瘤内壁的远侧表面处。
14.根据权利要求9所述的方法,其中提供包括可展开部分和栓塞卷绕部分的植入物的步骤还包括提供包括所述可展开部分和所述卷绕部分的连续的管状编织物。
15.根据权利要求14所述的方法,其中将所述栓塞卷绕部分放置成卷绕在所述展开的可展开部分内的步骤还包括沿其长度的大部分保持所述栓塞卷绕部分的基本上均匀的周长。
16.根据权利要求9所述的方法,其中提供包括可展开部分和栓塞卷绕部分的植入物的步骤还包括:
提供包括所述可展开部分的管状编织物;
提供包括所述栓塞卷绕部分的栓塞性线圈;以及
将所述管状编织物接合到所述栓塞性线圈。
17.根据权利要求9所述的方法,还包括:
提供脱离特征部;
将所述脱离特征部附连到所述栓塞卷绕部分;以及
将所述脱离特征部可拆卸地附接到所述递送系统。
18.根据权利要求17所述的方法,还包括:
使所述脱离特征部从所述递送系统脱离,从而仅将所述可展开部分、所述栓塞卷绕部分和所述脱离特征部植入所述动脉瘤中。
19.一种用于治疗动脉瘤的方法,包括:
提供包括编织部分和栓塞部分的植入物,所述编织部分包括形状记忆材料;
将所述编织部分成形为具有基本上球形预定形状;
将所述栓塞部分可拆卸地附接到植入物递送系统;
通过执行以下步骤将所述植入物和所述递送系统定位在微导管的内腔内:
将所述编织部分塌缩成尺寸适于配合在所述内腔内的形状,
将所述编织部分定位在所述内腔内,以从所述植入物的远侧端部朝近侧延伸,
将所述栓塞部分定位成从所述植入物的近侧端部朝远侧延伸,以及
将所述递送系统定位成从所述栓塞部分朝近侧延伸;
在所述编织部分未附接到所述递送系统时,使所述植入物和所述递送系统横穿所述微导管的所述内腔;以及
通过执行以下步骤从所述微导管排出所述植入物:
从所述微导管排出所述编织部分,
展开所述编织部分以形成至少部分地基于所述基本上球形预定形状的袋形状,
将所述栓塞部分从所述微导管排出,以及
将所述栓塞部分卷绕在所述编织部分的所述袋形状内。
20.根据权利要求19所述的方法,其中从所述微导管排出所述植入物的步骤还包括以下步骤:
将所述编织部分的所述袋形状中的开口定位在动脉瘤颈部附近;
将限定所述编织部分与所述栓塞部分之间的边界的折叠部定位在动脉瘤壁的远侧表面附近;以及
使所述栓塞部分的至少大部分横穿所述袋形状中的所述开口。
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2019
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Cited By (2)
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CN112656477A (zh) * | 2020-12-31 | 2021-04-16 | 杭州德诺脑神经医疗科技有限公司 | 动脉瘤闭塞装置及其微导管 |
WO2022143306A1 (zh) * | 2020-12-31 | 2022-07-07 | 杭州德诺脑神经医疗科技有限公司 | 动脉瘤闭塞装置及其微导管 |
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US11337706B2 (en) | 2022-05-24 |
US20220225997A1 (en) | 2022-07-21 |
EP3714812A1 (en) | 2020-09-30 |
KR20200115320A (ko) | 2020-10-07 |
US20200305886A1 (en) | 2020-10-01 |
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