CN108354699B - 复合血管分流器 - Google Patents
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Abstract
本发明公开了一种复合血管分流器,该血管分流器包括管状网孔框架,该管状网孔框架包括网孔覆盖物和开口。该管状网孔框架为可塌缩的,并且可被配置成在血管分流器被部署时从塌缩形状扩展为管状形状。网孔覆盖物适形于管状网孔的形状、被管状网孔框架围绕并比管状网孔框架为较不多孔的。开口位于网孔覆盖物内。递送线穿过开口,以便将分流器引导到动脉瘤上的位置中。
Description
技术领域
本公开整体涉及血管内医疗装置。本公开更具体地涉及用于治疗血管创伤和畸形的医疗装置。
背景技术
当前的血管分流器由跨动脉瘤的瘤颈部署的低孔隙度编织物组成,并且不仅覆盖跨动脉瘤的瘤颈的血管的周边,而且还覆盖位于动脉瘤的瘤颈近侧和远侧的一段原本健康的血管。血栓栓塞并发症常常由这些类型的装置引起。使用此类装置的患者长期服药以缓解装置血栓的风险。
理想的腔内分流器会仅治疗动脉瘤的瘤颈,从而最小化血管的内腔中的金属量和血栓栓塞并发症的可能性。然而,利用当前可用的成像技术,在三维空间中在荧光镜透视检查指导下将瘤颈覆盖物抵靠动脉瘤的瘤颈定位是较困难的。
通过仅以动脉瘤的瘤颈为目标来最小化血管中的金属量的血管内装置无法商购获得。具有试图治疗血管内动脉瘤的瘤颈的可商购获得的装置,诸如各种动脉瘤栓塞体系(例如栓塞线圈)。
发明内容
本公开描述了被设计为通过仅以动脉瘤的瘤颈为目标来最小化血管中的金属量的血管内分流装置的各个示例、用于部署血管内分流装置的装置以及用于引导和部署分流装置以覆盖动脉瘤的瘤颈的方法。
在本公开的一个示例中,血管分流器包括管状网孔框架,该管状网孔框架包括网孔覆盖物和开口。该管状网孔框架为可塌缩的并被配置成在血管分流器被部署时从塌缩形状扩展为管状形状。网孔覆盖物适形于管状网孔的形状、被管状网孔框架围绕并比管状网孔框架为较少多孔的。开口位于网孔覆盖物内。
在一个示例中,管状网孔框架具有圆形横截面。在一个示例中,网孔覆盖物具有倒圆的周边。在另一个示例中,网孔覆盖物具有圆形周边。在一些示例中,网孔覆盖物与管状网孔框架成一体。在其他示例中,网孔覆盖物与管状网孔框架分开并附接到管状网孔框架。在一个示例中,网孔覆盖物通过焊接附接到管状网孔框架。在另一个示例中,网孔覆盖物通过网孔覆盖物的网孔股线与管状网孔框架的网孔股线交织而附接到管状网孔框架。
在本公开的一个示例中,用于部署血管分流器的装置包括中空的微导管,该中空的微导管包括管状外壁、远侧端部和近侧端部。在一个示例中,微导管的远侧端部包括基本上垂直于微导管的纵向轴线的横向开口,并且还包括基本上平行于该纵向轴线的纵向开口。纵向开口与横向开口相交。装置还包括递送线,该递送线包括远侧节段、近侧节段和位于远侧节段和近侧节段之间的接头。递送线的远侧节段的至少一部分被配置成采用弯曲构型。远侧节段具有比近侧节段小的横截面。
在一个示例中,递送线的远侧节段的被配置成采用弯曲构型的一部分被预成形为弯曲构型并被配置成在递送线的远侧节段从微导管部署时从伸直构型恢复为弯曲构型。
在另一个示例中,递送线包括牵拉线。牵拉线定位在递送线的内腔中并终止于远侧节段的末端处。牵拉线的近侧端部可被牵拉以向牵拉线施加张力,该张力将递送线的远侧节段的至少一部分拉动至弯曲构型。
在一个示例中,射线不可透标记物可固定至位于递送线的远侧节段和近侧节段之间的接头。在另一个示例中,射线不可透标记物可固定至递送线的远侧节段的末端。在另一个示例中,递送线的远侧节段的远侧末端可为由射线不可透材料形成的线圈。在另一个示例中,射线不可透标记物可固定至微导管的远侧端部。在一个示例中,固定至微导管的远侧端部的射线不可透标记物可位于横向开口和纵向开口的近侧端部之间。在另一个示例中,固定至微导管的远侧端部的射线不可透标记物包括开口环形状。在另一个示例中,开口环形状的开口横跨微导管的纵向开口。
在本公开的一个示例中,用于部署血管分流器的方法包括:跨血管中的动脉瘤的瘤颈沿远侧方向推进微导管,推进递送线的远侧末端离开微导管,旋转微导管,使得弯曲的递送线末端通过微导管中的纵向狭槽离开,从而使网孔覆盖物与动脉瘤入口径向对齐,以及将递送线的远侧末端引导至动脉瘤中。该方法还包括在保持递送线的位置时沿近侧方向抽出微导管,使得血管分流器的自扩展框架抵靠血管的内壁打开,并且递送线的远侧末端跨动脉瘤的瘤颈引导血管分流器的网孔覆盖物。
在另一个示例中,方法还包括经由放射成像装置确认递送线的远侧末端位于动脉瘤内。在另一个示例中,方法包括将递送线抽出到微导管中并将递送线和微导管从患者抽出。
附图说明
图1是根据本公开的分流器的附图,其示出了分流器的主要部件和它们彼此之间的关系。
图2是根据本公开的用于递送分流器的微导管的附图,其示出了微导管的主要部件和它们彼此之间的关系。
图3是根据本公开的用于递送分流器的递送线的一个示例的附图,其示出了递送线的主要部件和它们彼此之间的关系。
图4是根据本公开的具有递送线和分流器的微导管的一个示例的剖视图,该递送线和分流器被安装来为放置于血管中作准备。
图5a-5f是根据本公开的血管中的动脉瘤的一系列附图,其示出了用于将分流器置于血管中以封闭动脉瘤的步骤序列的示例。
图6是示出了用于将分流器置于血管中以封闭动脉瘤的步骤序列的示例的流程图。
图7是根据本公开的处于塌缩构型的分流器的附图。
图8是根据本公开的图7的塌缩分流器的横截面的附图。
图9是根据本公开的图7的塌缩分流器的另一横截面的附图。
具体实施方式
现在参考附图,其中相同的附图标记表示相同的部分,将详细地公开计算装置和方法的各种示例。
图1是分流器100的附图。分流器100包括具有高孔隙度的自扩展管状网孔框架102。“高孔隙度”指示部件的网孔包括比血管覆盖更多的开放空间。高孔隙度部件因此具有低金属-动脉比率。金属-动脉比率通过将装置在动脉中覆盖的圆柱面积除以包含该装置的动脉段的总圆柱面积来计算。管状网孔框架102具有扩展(自由)状态和塌缩状态。扩展状态如图所示。管状网孔框架102必须在外部被压缩以进入塌缩状态,并在合适条件下恢复扩展状态。在一些示例中,管状网孔框架102可在一移除外部约束就在内部张力的作用下自动恢复扩展状态。在其他示例中,管状网孔框架102可响应于热输入或电信号而恢复扩展状态。此类管状网孔框架102的一个示例可由形状记忆合金诸如镍钛合金(镍钛诺)制成。
低孔隙度(高金属-动脉比率)网孔覆盖物104与管状网孔框架102结合。网孔覆盖物104被置于管状网孔框架102的中间节段上方。网孔覆盖物104大体可具有圆形的、倒圆的或长方形的形状110。开口106在网孔覆盖物104的中心形成。开口106足够大以允许引导装置诸如可操纵射线不可透导丝(或微导管)穿过该开口。
在一些示例中,网孔覆盖物104可被集成为管状网孔框架102的一部分。在一个示例中,网孔覆盖物104可由与管状网孔框架102相同的细丝但以更紧密的方式织成。在其他示例中,网孔覆盖物104可为附接到管状网孔框架102的独立元件。在一个此类示例中,网孔覆盖物104可通过焊接附接到管状网孔框架102。在另一个此类示例中,网孔覆盖物104可通过粘合剂附接到管状网孔框架102。在另一个示例中,网孔覆盖物104的细丝可与管状网孔框架102的细丝交织。在另一个此类示例中,可通过暂时或局部地熔融网孔覆盖物104或管状网孔框架中的任一者以使两者熔合在一起(与焊接相反,焊接会暂时熔融两者以形成粘结)而使网孔覆盖物104附接到管状网孔框架102。在另一个此类示例中,可通过将网孔覆盖物104夹置于管状网孔框架104的层之间而使网孔覆盖物104附接到管状网孔框架102,反之亦然。
图7示出了处于塌缩状态的分流器100。塌缩部分700在管状网孔框架102和网孔覆盖物104中形成,以在分流器推进穿过微导管200用于放置于动脉瘤上方时容纳递送线300的远侧端部302(关于用于递送和放置分流器100的工具和技术的更多细节请参见下文)。图8示出了仅穿过管状网孔框架102的塌缩分流器100的横截面。塌缩部分100可在该剖视图中看得更清楚。图9示出了穿过开口106的中心的塌缩分流器100的横截面。这样,可看见塌缩部分700、开口106、管状网孔框架102和网孔覆盖物104。
图2示出了用于递送分流器100的微导管200。微导管200具有管状外壁202、远侧端部204、近侧端部206和纵向轴线210,该纵向轴线沿其长度与管状外壁202的中心大约重合。远侧端部包括横向开口208和纵向开口212。在一些示例中,横向开口208可基本上垂直于纵向轴线210。在一些示例中,横向开口208可与纵向轴线210成角度。
纵向开口212可为狭槽或具有沿微导管200的长度的长尺寸和沿微导管200的圆周(或其他非圆形周边)的短尺寸的类似形状。纵向开口212的一个端部与位于微导管200的远侧端部204处的横向开口208相交214。纵向开口的另一个端部可为正方形的(即包括具有或不具有半径的直角角部)、半圆形的或椭圆形的。
微导管200的远侧端部24还可包括射线不可透标记物218。射线不可透标记物218允许临床医生使用放射仪器观察微导管200的远侧端部204在患者的血管***内的位置。例如,临床医生可使用荧光镜透视检查、数字减影血管造影、旋转血管造影、计算机断层扫描(CT)、锥形束CT等来观察射线不可透标记物218的位置。在一些示例中,射线不可透标记物218可为圆形带或环形形状。在一些其他示例中,圆形带可为开口环形状,其中环中的开口与纵向开口212对齐。
图3示出了用于递送分流器100的可操纵递送线300。递送线300被部署在微导管200内。递送线300包括远侧节段302、近侧节段304和位于远侧节段302和近侧节段304之间的接头306。递送线300的远侧节段302的至少一部分被配置成采用弯曲构型。远侧节段302具有比近侧节段304小的横截面。在一些示例中,远侧节段302可相对于近侧节段304滑动。这允许递送线的末端在分流器被跨动脉瘤的瘤颈放置之后回缩。在一些示例中,远侧节段302和近侧节段304均具有圆形横截面。在其他示例中,远侧节段302和近侧节段304可具有非圆形横截面。例如,远侧节段302或近侧节段304中的任一者可具有椭圆形、长方形、卵形、三角形或四边形横截面。此外,在一些示例中,远侧节段302或近侧节段304中的任一者的非圆形横截面可不具有沿递送线300的长度的一致角取向。远侧节段302包括末端310。在一些示例中,末端310可包括射线不可透标记物314。
在一个示例中,递送线300的远侧节段302的被配置成采用弯曲构型的一部分被预置为弯曲构型,并在从微导管部署时从伸直构型恢复为弯曲构型。因此,当递送线处于其自由状态时,该节段处于弯曲构型。当递送线被***微导管中时,微导管的内径约束递送线并迫使弯曲构型变为伸直构型。当递送线从微导管被部署时,该节段恢复至其预置的弯曲构型。弯曲节段可由柔性的弹性材料形成。例如,弯曲节段可由弹簧钢形成,或可被热处理以形成处于其自由状态的弯曲节段。
在另一个示例中,至少一根牵拉线308被定位在递送线300的内腔316内。一根或多根牵拉线308附接到远侧节段302的末端310,使得当牵拉线308从递送线300的近侧节段304的近侧端部318被牵拉时,其使得远侧节段302的靠近末端310的至少一部分弯曲。这允许临床医生将递送线300的远侧节段302的末端310引导到动脉瘤中。在一些示例中,整个远侧节段302可在牵拉线308被牵拉时弯曲。在其他示例中,近侧节段304的一部分也可在牵拉线308被牵拉时弯曲。
位于远侧节段302和近侧节段304之间的接头306具有与近侧节段304至少一样大的横截面。接头306用于推动分流器100离开微导管200以用于跨动脉瘤的瘤颈放置,如下文将更详细地解释。在一些示例中,接头306还可包括射线不可透标记物312。
图4是示出了具有递送线300和分流器100的微导管200的剖视图,该递送线和分流器被安装来为放置于血管中作准备。通过将开口106引导到导丝300的远侧节段302上方而将分流器100安装在远侧节段302上方,直到管状网孔框架102与位于递送线300的远侧节段302和近侧节段304之间的接头306汇聚。分流器100的管状网孔框架102随后被压缩为其塌缩状态、预加载至导引器(未示出)中以及传送至微导管内腔220中。
图5a-5f是示出了用于将分流器100置于血管514中以封闭动脉瘤512的步骤序列的一个示例的一系列附图。在图5a处,微导管200被跨动脉瘤512的瘤颈516推进。在图5b处,如果必要的话,检查并调整微导管200的纵向开口212与动脉瘤的径向对齐。递送线300的远侧节段302的末端310随后被推进离开微导管200并被引导穿过动脉瘤512的瘤颈516。递送线可具有预设的曲率,如上所述,或可使用牵拉线308引导。递送线通过穿过孔106与植入物接合但不附接。在图5c处,在确认远侧节段302的末端310坐置于动脉瘤512中之后,分流器100可被部署。通过在保持递送线300的位置时牵拉回微导管200来部署分流器100。
在图5d处,自扩展管状框架102抵靠血管514的内部打开,而分流器100通过其开口106沿递送线300的远侧节段302而被引导。在图5e处,分流器100从微导管200被完全部署并被扩展。在图5f处,递送线300被抽出到微导管200中,并且该递送线和该微导管均可从患者抽出。
图6是示出了用于将分流器置于血管中以封闭动脉瘤的步骤序列的流程图。在600处,临床医生跨血管中的动脉瘤的瘤颈沿远侧方向推进微导管。在602处,临床医生推进递送线的远侧末端离开微导管,并将递送线的远侧末端引导到动脉瘤中。在604处,临床医生经由放射成像装置确认递送线的远侧末端位于动脉瘤内。放射成像装置可包括例如荧光镜透视检查、数字减影血管造影、旋转血管造影、计算机断层扫描(CT)、锥形束CT等。在606处,临床医生从微导管部署分流器。在608处,临床医生在保持递送线的位置时沿近侧方向抽出微导管,使得血管分流器的自扩展框架抵靠血管的内壁打开,同时递送线的远侧末端跨动脉瘤的瘤颈引导血管分流器的网孔覆盖物。在610处,临床医生将递送线抽出到微导管中。在612处,临床医生将递送线和微导管从患者抽出。
为了便于理解所公开技术的原理和特征结构,上面解释了例示性示例。被描述为构成所公开技术的各种元件的部件旨在是说明性的而非限制性的。将执行与本文所描述的部件相同或相似功能的许多合适的部件旨在涵盖在所公开的电子装置和方法的范围内。本文未描述的此类其他部件可包括但不限于例如在所公开的技术开发之后开发的部件。
还必须注意的是,除非上下文清楚地指明,否则在本说明书和所附权利要求中所用的单数形式“一个”、“一种”和“所述”包括复数指代物。
“包含”或“含有”或“包括”是指至少命名的部件、元件或方法步骤存在于制品或方法中,但不排除存在其他部件、材料、元件、方法步骤,即使其他此类部件、材料、元件、方法步骤具有与命名的那些相同的功能。
还应当理解,提到一个或多个方法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,还应当理解,提到装置或***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。
本专利申请中描述的设计和功能本质上旨在是示例性的,并且并不旨在以任何方式限制本公开。本领域普通技术人员将理解,本公开的教导可以以各种合适的形式来实现,包括本文公开的那些形式以及本领域普通技术人员已知的附加形式。
虽然已经结合目前被认为是最实际的内容和各种示例描述了本公开的某些示例,但是应当理解,本公开内容不限于所公开的示例,而相反地,旨在涵盖包括在所附权利要求的范围内的各种修改形式和等同布置。尽管本文采用了特定术语,但是这些术语仅以一般性意义和描述性意义被使用并且不出于限制的目的。
该书面描述使用示例来公开技术的某些示例,并且还使得本领域任何技术人员能够实践该技术的某些示例,包括制造和使用任何设备或***并执行任何所包括的方法。该技术的某些示例的可取得专利的范围在权利要求中加以定义,并且可包括本领域技术人员想到的其他示例。如果这些其他示例具有与权利要求的文字语言相同的结构元件,或者如果它们包括与权利要求的文字语言无实质差异的等同的结构元件,则此类其他示例旨在处于权利要求的范围内。
Claims (10)
1.一种用于部署血管分流器的装置,所述装置包括:
微导管,所述微导管包括管状外壁、远侧端部和近侧端部,所述远侧端部包括横向开口和纵向开口,其中所述纵向开口与所述横向开口相交;和
递送线,所述递送线包括远侧节段、近侧节段和位于所述远侧节段和所述近侧节段之间的接头,所述接头构造成推动所述血管分流器,其中:
所述远侧节段具有比所述近侧节段小的横截面;并且
其中所述远侧节段能够从所述近侧节段的近侧端部操纵,其中所述递送线的所述远侧节段的至少一部分被配置成采用弯曲构型。
2.根据权利要求1所述的用于部署血管分流器的装置,其中所述横向开口基本上垂直于所述微导管的纵向轴线,并且所述纵向开口基本上平行于所述微导管的所述纵向轴线。
3.根据权利要求1所述的用于部署血管分流器的装置,其中所述递送线的所述远侧节段的被配置成采用弯曲构型的所述部分被预成形为所述弯曲构型并且被配置成在所述递送线的所述远侧节段从所述微导管部署时从伸直构型恢复为所述弯曲构型。
4.根据权利要求1所述的用于部署血管分流器的装置,还包括牵拉线,所述牵拉线定位在所述递送线的内腔中并终止于所述远侧节段的末端处;
其中所述牵拉线的近侧端部能够被牵拉以在所述远侧节段的至少一部分中形成所述弯曲构型。
5.根据权利要求1所述的用于部署血管分流器的装置,还包括固定至所述远侧节段和所述近侧节段之间的所述接头的射线不可透标记物。
6.根据权利要求1所述的用于部署血管分流器的装置,还包括固定至所述远侧节段的末端的射线不可透标记物。
7.根据权利要求1所述的用于部署血管分流器的装置,还包括固定至所述微导管的所述远侧端部的射线不可透标记物。
8.根据权利要求7所述的用于部署血管分流器的装置,其中固定至所述微导管的所述远侧端部的所述射线不可透标记物位于所述横向开口和所述纵向开口的近侧端部之间。
9.根据权利要求8所述的用于部署血管分流器的装置,其中固定至所述微导管的所述远侧端部的所述射线不可透标记物包括开口环形状。
10.根据权利要求1所述的用于部署血管分流器的装置,其中所述递送线的所述远侧节段的所述弯曲部分穿过形成于管状网孔血管分流器中的开口,以便在所述管状网孔血管分流器的部署期间将所述管状网孔血管分流器引导到动脉瘤的瘤颈上方的位置中。
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