CN106456182B - 血管闭塞装置 - Google Patents

血管闭塞装置 Download PDF

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CN106456182B
CN106456182B CN201480076091.5A CN201480076091A CN106456182B CN 106456182 B CN106456182 B CN 106456182B CN 201480076091 A CN201480076091 A CN 201480076091A CN 106456182 B CN106456182 B CN 106456182B
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希拉·沃纳
杰奎琳·马亚西斯
梁惠萍
温迪·格拉茨克
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Terumo Corp
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Abstract

一种血管疾病治疗***、用于闭塞血管部位的设备和闭塞血管疾病的方法。血管疾病治疗***,包括:第一管;可在所述第一管内滑动的第二管;与所述第二管的远端相联的容纳装置;所述容纳装置具有非展开状态和展开状态;当处于所述展开状态时,所述容纳装置的尺寸满足将所述容纳装置设置于血管疾病的入口处;所述容纳装置具有接收用于所述血管疾病的治疗的栓塞剂的开口。

Description

血管闭塞装置
相关申请
本申请要求2013年12月20日提交的申请号为61/919667、名称为血管闭塞装置的美国临时专利申请,以及2014年1月7日提交的申请号为61/924662、名称为血管塞的美国临时专利申请的优先权权益。以上所有申请的全部内容通过引用被并入本申请中。
技术领域
本发明涉及一种血管疾病治疗***、用于闭塞血管部位的设备和闭塞血管疾病的方法。
背景技术
闭塞装置通常被用作诸如动脉瘤、房间隔缺损、左心耳、卵圆孔未闭、动脉导管未闭等的血管疾病的治疗。栓塞线圈的使用是一种闭塞的方法。然而,有时可能会出现困难。例如,在左心耳进行闭塞可能非常困难,因为左心耳的口部形状存在着潜在的变化,并且左心耳的形状及几何结构也存在着潜在的变化。另外,使用栓塞线圈的一种可能的并发症在于在血管内线圈从目标治疗部位脱落的风险。因此,一种采用能够降低从目标治疗部位脱落风险的栓塞线圈的闭塞***将是有益的。另外,大体上能够改善闭塞过程的装置和方法也将是有益的。这样一个***将被广泛用于治疗各种疾病,包括左心耳闭塞、动脉瘤、房间隔缺损、卵圆孔未闭、动脉导管未闭、血管关断以及其他类似的血管疾病。
发明内容
在一实施例中,闭塞***包括容纳袋和栓塞线圈。
在一实施例中,闭塞***包括容纳袋、球囊及栓塞线圈。
在另一实施例中,描述了用于闭塞***的栓塞线圈。
在另一实施例中,闭塞***包括保护盘及栓塞线圈。
在另一实施例中,闭塞***包括保护网及栓塞线圈。
在另一实施例中,闭塞***包括球囊及栓塞线圈。
在另一实施例中,闭塞***包括具有薄片的栓塞线圈。
在另一实施例中,用于闭塞***的栓塞线圈包括薄片。
在另一实施例中,描述了具有内部结构和外部结构的闭塞装置。
在另一实施例中,描述了具有内部结构和外部膜层的闭塞装置。
在另一实施例中,描述了具有内部和外部结构以及中间膜层的闭塞装置。
在另一实施例中,闭塞装置可折叠。
在另一实施例中,闭塞装置不可折叠。
本发明的这些目的以及特征将通过以下附图及具体实施方式的描述而被详细说明。
附图说明
图1-5是根据本发明的一个实施例,用于治疗血管缺损的一种闭塞***的方案效果图。
图6-12是根据本发明的另一实施例,一种闭塞***的方案效果图。
图13是根据本发明的另一实施例,一种闭塞***的方案效果图。
图14是根据本发明的又一实施例,一种闭塞***的方案效果图。
图15-16是根据本发明的一种用于闭塞***的栓塞线圈的平面图。
图17-19说明了根据本发明的一种具有内部和外部结构的闭塞装置。
图20说明了根据本发明的图17的外部结构支撑模式。
图21-22说明了根据本发明的一种具有内部结构和外部膜层的闭塞装置。
图23说明了根据本发明的一种具有内部和外部结构以及中间膜层的闭塞装置。
图24说明了根据本发明的一种用于闭塞装置的输送***。
具体实施方式
I.血管闭塞***
闭塞***用于闭塞血管治疗部位。在某些特定的示例中,所述闭塞***用于治疗所述左心耳,虽然该***也可以用于其他用途,如动脉瘤闭塞或其他闭塞的目的。所述左心耳为位于左心房的一个口袋。在一些情况下可能会在所述心耳中形成血液凝块。随着时间的推移,由该血液凝块形成的血栓可能会转移并导致在血管的其他区域形成血栓,从而导致诸如中风的缺血性损伤。因此,左心耳闭塞常用来限制并且有时可以防止血栓的迁移。
所描述的所述实施例可以用于闭塞左心耳、房间隔缺损、卵圆孔未闭、动脉瘤以及其他血管疾病。
图1示出了一种闭塞***。所述***被配置在所述血管内并且位于所述左心耳(LAA)24的附近。所述***通过导管10进行配置并且包括输送管12。在一示例中,所述***通过导向导管10进行输送,在另一示例中,导管10是一通有管12的微导管。容纳袋20位于所述输送管的远端附近。所述容纳袋包括近端躯干部22。在一示例中,所述容纳袋20为一包括一种或多种金属(如镍钛合金、不锈钢、铬或钴)丝的网状物。所述网状物也可以包含编织为网状物的一种或多种造影线(即铂、钯或钽)以增加显影性和可视性。
所述输送管12在其远端附近具有止动环18;所述止动环18固定在所述输送管12的内表面。远端具有柱塞16的推杆14用于推动所述容纳袋20。所述容纳袋20不受所述止动环18的限制。在一示例中,所述容纳袋20是由高度适形性的网状物制成,因而能够采用灵活的形状以围绕着所述止动环18定位。在另一示例中,所述容纳袋20具有一锥形轮廓,或不填充所述输送管12,因此所述止动环18并不限制所述容纳袋的移动。所述推杆可以由金属材料(即不锈钢、镍钛合金、钴铬合金或其它材料)构成并且在所述推杆14远端连接有较大直径的柱塞16。
所述输送管12位于所述左心耳24的口部(颈或开口)30区域。所述输送管可以位于所述口部的近端,甚至在所述口部,或者在所述左心耳内。使用者推动推杆14以将容纳袋20推进所述LAA 24。所述柱塞16在超过一特定点时通过与止动环18的相互作用被禁止移动。一旦所述推杆14被推到特定点时,所述柱塞16碰到止动环18,该止动环18限制任何进一步的移动。所述柱塞16推动容纳袋20的所述躯干部22。由于来自所述柱塞16的推力,所述容纳袋推进所述LAA,其中当远端部分位于所述LAA内时所述袋的近端部分位于所述口部附近。根据腔体的尺寸,所述容纳袋20可以填充所述LAA的相当大的部分,或者大多在所述口部内。容纳袋20的预期功能是作为用于随后放置的栓塞线圈的填充容器,以防止血液流入和流出目标部位。
在图2中,推杆14被推到柱塞16碰触到止动环18的点。容纳袋20被推进所述LAA,且撤出推杆14(图3)。参考图4,另一个远端接有栓塞线圈26的推杆28通入管12。所述栓塞线圈26被推入所述容纳袋20。热、电或者机械分离装置能够被用于将所述线圈26从所述推杆28上分离。能够被使用的这样一种热分离***如专利号为8182506的美国专利所示,现将其整体纳入参考。另一种能够被使用的分离***如专利号为6620152的美国专利所示,现将其整体纳入参考。参考图5,可以重复该步骤以用额外的栓塞线圈26填充所述袋体。所述线圈26保留在所述容纳袋20内且所述线圈26在所述袋内形成硬质栓塞块并且填补畸形颈的空间以防止血液流入畸形颈。
可以使用各种类型的栓塞线圈填充所述容纳袋。包括专利号为8273100,8066036,6375669,6015424,8323306,8377091的美国专利,以及公开号为2011/184455的美国专利所描述的示例,现将这些整体纳入参考。所述栓塞线圈可以采用聚合物、水凝胶,和/或诸如铂、镍钛合金、不锈钢的金属。
另一实施例包含一种具有柔性球囊(未示出)的所述容纳袋闭塞***。在一示例中,所述柔性球囊(未示出)预加载在所述容纳袋20的远端部分,从而提供了一个缓冲以使所述线圈停止在所述容纳袋20的远端。所述球囊将被预加载在所述容纳袋20上。
在另一示例中,将放置一个球囊导管,所述导管球囊放置在所述畸形颈,以便使所述线圈不从所述容纳袋20脱落。一旦所述袋20充满,所述球囊将被从所述导管上分离。换句话说,所述柔性球囊将在栓塞线圈步骤后引入,以便密封所述畸形颈并且提供一个用于所述栓塞线圈的近端屏障以防止迁移。
上述实施例虽然展示了用于闭塞左心耳的用途,其还可以被用于包括动脉瘤、房间隔缺损、卵圆孔未闭或其他闭塞目的在内的各种用途。
根据本发明如图6-12所示的另一实施例。一种闭塞***包括具有内部管40的管状组件31,该内部管40设置于外部管38内。所示外部管38具有内腔以容纳所述内部管40,并且所述内部管40同样具有内腔。
网状结构32被设置在所述管状组件31的远端,并且于位置34处被固定在所述内部管40的远端且于位置36处被固定在所述外部管38的远端。这样的固定可以采用各种本领域技术人员所知的技术,包括机械连接、化学固定、二次成型或各种它们的组合。所述网状结构32可以由网状的镍钛合金、钴铬、或其他金属丝构成。造影材料(如钽或铂)可选地用于网状物中以增强可视性。
所述网状结构32通常具有一个细长的形状,但也将根据所述管状组件31的使用者操作情况采用盘状、束状,详细情况将在下面细致说明。
所述内部管40相对所述外部管38可移动。由于所述网状结构31的一端连接于所述外部管38并且其相反一端连接于所述内部管40,内部管40相对所述外部管38的移动将选择性地使得所述网状结构32采用如图7-10所示的内部管缩回的形状。
例如,由于所述内部管40相对所述外部管38缩回,所述网状结构32将采用一个更为凸起的盘状。这样一种形状能够有效地用于密封治疗部位的口部的颈部(例如左心耳的所述口部)。一旦所述网状结构32被配置为所需要的形状,例如一密封的形状,所述内部管40能够用于输送诸如栓塞线圈的栓塞剂以填充治疗部位,例如填充畸形。
参考图11-12所示的所述管状组件31的所述近端部分。所述近端部分包括止血阀42,其连接第一配件46,该第一配件反过来连接外部管38。所述第一配件46以公-母的关系与所述止血阀42的第二配件48相互螺纹接合。止血阀42包括接口44。所述止血阀42以公-母的关系与第三配件50相互螺纹接合。所述管状组件31的所述内部管40通过所述止血阀42和所述第三配件50的通道延伸。
当第三配件50完全超过所述止血阀42时,所述第三l配件50夹紧在所述内部管40上并且将其固定于相对于外部管38的位置上。换句话说,所述第三配件50能够用于将所述内部管40锁紧在相对所述外部管38的位置上并且因而固定了网状结构的形状。
在一示例中,所述内部管相对所述外部管38缩回以为网状结构32创造一个最佳的口部密封形状。然后当诸如线圈的栓塞剂通过所述内部管40输送至血管治疗部位时,所述第三配件50被锁定以保持所述网状结构32的密封形状。
所述内部管40的所述近端具有引导部分52。线圈能够由该部分引导,或者引导部分52能够被连接在注射器或其他装置以引导其他栓塞剂(即液体栓塞剂)通过所述内部管40进入所述治疗部位。
在此实施例中,内部管40就像一微导管,因为其能被用于引导栓塞剂材料,且外部管38就像内部管40的护套。
根据本发明的装置可以通过引导导管被输送至目标治疗部位。所述引导导管能缩回或者所述网状结构32能够被从所述引导导管中推出以露出所述网状结构32。一旦所述装置到达所述治疗部位,所述使用者可以控制所述网状结构32的形状以密封所述所述治疗部位的口部或颈。一旦所述口部被密封,所述使用者可以通过所述内部管40植入栓塞剂以填充所述血管,而所述网状结构32将防止所述栓塞剂的迁移。所述栓塞剂,在一示例中为线圈,将形成栓塞块以密封所述畸形的内部并从而防止血液流入所述畸形/治疗部位。所述网状结构32之后可以缩回(通过内管40和外管38的相对运动)到其细长的形状并被撤回。
在一示例中,如图6-12的所述***具有工作长度117cm以及总长135cm,并且兼容.018英寸或.035英寸的栓塞线圈。所述网状结构32可以具有0.7cm的压缩长度以及2.5cm的拉伸长度。外部管38可以具有.079英寸的内径且具有.092英寸的外径,而内部管40可以具有.053英寸的内径且具有.066英寸的外径。在一示例中,所述网状结构32具有完全拉伸半径为10mm且完全压缩半径为35mm,从而可以密封具有宽度10-35mm的口部。在一示例中,所述***通过8或者8.5F的引导导管被输送。
上述实施例虽然展示了用于闭塞左心耳的用途,其也可以用于包括动脉瘤、房间隔缺损、卵圆孔未闭或其他闭塞目的在内的各种用途。
图13展示了闭塞***的另一实施例。在此实施例中,网状物54位于管58的远端。所述网状物54可以由一个网状的镍钛合金,钴铬,或其他金属丝组成。造影材料(如钽或铂)可用于网状物54以增强可视性。
管58类似于前述实施例中的外部管38;但是,在本实施例中未用到内部管。所述网状物54的近端固定在所述管58的远端,并且所述网状物54的远端开口。机械连接、化学固定、二次成型或各种它们的组合可用于将所述网状物固定在所述管58的远端。所述网状物自然地具有用于密封所述治疗部位的口部或颈部的所述颈部的喇叭形。引导器,诸如止血阀或其他引导***,设置在所述管58的近端并且用于引导栓塞线圈或其他栓塞剂通过管58。
在此实施例中,管58就像是一微导管,因为其能够被用于引导栓塞材料。
所述装置可以通过引导导管被输送至目标治疗部位24。一旦到治疗部位,所述引导导管被收回或所述网状物54被从所述引导导管上推出。所述网状物的开口面位于所述颈部的远端,以便为了随后引入的栓塞剂密封所述颈部。栓塞剂,诸如线圈,被引导通过管58并且所述网状物密封所述治疗部位的颈部以防止所述线圈掉落。所述栓塞剂将在治疗部位内形成栓塞块并从而切断所述动脉瘤、左心耳或者血管畸形的血流。所述网状物54之后可以被撤回。
在一示例中,图13所示的***全长为120cm,工作长度为50cm并且所述网状物54直径为10毫米且拉伸(即当被压缩在输送到管内)长度为3cm且非拉伸(即当处于展开状态)长度为1.5cm。在一示例中,所述***通过8或者8.5F的引导导管被输送。
上述实施例虽然展示了用于闭塞左心耳的用途,其也可以用于包括动脉瘤、房间隔缺损、卵圆孔未闭或其他闭塞目的在内的各种用途。
在如图14所示的另一实施例中,所述闭塞***采用膨胀球囊60密封所述口部。所述闭塞***还采用管(例如微导管)62,其位于所述球囊的近端并且穿过所述球囊。所述管62可以包含膨胀腔,或用于膨胀和收缩所述球囊60的单独的膨胀腔。所述管用于引导栓塞剂(即栓塞线圈)。
所述***位于所述治疗部位的远端并且所述球囊60在所述颈部或口部24处膨胀。栓塞剂(即线圈)接着被引导通过所述管直至所述畸形,并且所述膨胀的球囊确保所述线圈不会掉落。所述栓塞线圈,如果使用的话,将形成为栓塞块,然后所述球囊60能够被收缩并被移除,且所述栓塞块将留在所述口部内以防止血液流进所述畸形。任何聚合物均可被用在球囊上,例如PTFE。
在一示例中,管62具有内径.072英寸以及外径.092英寸,并且所述***具有工作长度101cm以及总长114cm。
上述实施例虽然展示了用于闭塞左心耳的用途,其也可以用于包括动脉瘤、房间隔缺损、卵圆孔未闭或其他闭塞目的在内的各种用途。
可以使用各种类型的栓塞线圈填充所述畸形,利用所述的闭塞***。包括专利号为8273100,8066036,6375669,6015424,8323306,8377091的美国专利,以及公开号为2011/184455的美国专利所描述的示例,现将这些整体纳入参考。所述栓塞线圈可以采用聚合物、水凝胶,和/或诸如铂、镍钛合金、不锈钢的金属。
所述线圈通常是通过推杆被输送,并且通常使用切断或分解***以将所述线圈从所述推杆上切断。热、电或者机械分离装置能够被用于将所述线圈从所述推杆上分离。能够被使用的这样一种热分离***如专利号为8182506的美国专利所示,现将其整体纳入参考。另一种能够被使用的分离***如专利号为6620152的美国专利所示,现将其整体纳入参考。
II.栓塞线圈
图15-16展示了一种能够用于如图1-14所示的闭塞***实施例的栓塞线圈。由于所述治疗部位(例如左心耳)的潜在尺寸,以及潜在的复杂几何结构,闭塞或将存在困难。
图15-16说明了一种具有耦合器或连接器68的栓塞线圈64,其与所述推杆连接,该连接器68能被分解以在治疗部位释放所述栓塞线圈64。所述线圈64还包括固定在所述线圈64上的薄片66。在一示例中,所述薄片66胶粘或是系在所述线圈64的一端而其另一端自由,所述薄片66可以由聚合物构成或者可以是一金属网状物。在一示例中,所述薄片66为具有孔的矩形或圆形/环形/椭圆形,且其位于所述线圈64上且被系在、胶粘或是通过其他方式与所述线圈固定。
图15展示了具有处于展开位置的所述薄片66的所述线圈64。多个所述薄片66可以沿着所述栓塞线圈64的长度设置且增加的薄片66增加了所述线圈64潜在的填充空间,由于所述薄片的一端是开放的,因此可以自由地填补治疗区域内的开放空间。所述薄片66也将提供对于所述线圈64的固定点,在此处所述薄片66可以与血管壁接触,从而促进目标区域内的线圈的稳定性。
图16显示了在导管70内的一个输送结构中,具有附加的所述薄片66的所述栓塞线圈64。所述的栓塞线圈64还可以用于闭塞一动脉瘤、房间隔缺损、卵圆孔未闭等。
在一实施例中,薄片66是聚合物,在另一实施例中,其是一编制的金属网状物,在另一实施例中,所述薄片是一聚合物与金属网状物的组合物。在另一实施例中,所述薄片66并不与所述线圈固定且沿着所述线圈的长度移动。在另一实施例中,所述薄片66完全不与所述线圈固定且能够独立使用(即装载所述薄片以替代使用栓塞线圈,先使用所述薄片再接着进行线圈闭塞)。
本领域的普通技术人员可以意识到图1-16所示的实施例可以被交替使用。例如,通过将所述柱塞/袋整合至穿过所述网状物的内导管的远端而将图1-5所示的实施例与图6-12所示的实施例一同使用。类似地,这一概念可以被纳入图13-14所示的实施例中。
III.血管塞
根据如图17所示的本发明的血管塞的一个实施例。所述塞包括内层100和外层120。所述外层120可以由海波管构成,其作为框架或是支架,并且与所述血管壁在一个或多个位置接触以防止所述塞移动。所述外层120可以是金属并由镍钛合金、不锈钢、钴铬、以上各种组合或其他材料构成。在一示例中,外层120为激光切割的钛合金海波管。
所述内层100包括网状物,其可以被热成型为特定性状(例如球形)。所述内层100可以是金属并由镍钛合金、不锈钢、钴铬、以上各种组合或其他材料构成。包括所述内层100的线优选地具有最小的空隙以限制流经所述塞的血液的量,以便促进治疗部位的闭塞。在一实施例中,内层100由144个约96微米的孔径且外径.001英寸的线编织。
在一示例中,外层120由5-10个支柱130组成。在另一示例中,外层120由6个支柱130组成且具有一细长的球形形状。当沿着所述塞的轴线观察时(即沿着所述塞的轴线查看其一端时),所述外层120的所述近端和远端呈现出一种类似星形形状,其由如图20所示的一个或多个单元140组成。图20所示的星形图案是基于6个支柱图案,其中每个单元140被看作构成一个支柱130。如图17所示,所述支柱130之后融合成一个更扩大的、更细长的球形框架形状。
图18-19说明了具有内层100和外层120的血管塞,其中所述外层120具有更为球形的形状并且其与图17中的外层120的形状相比表现的更为接近所述内层100的形状。在如图18所示的一示例中,当沿着所述塞的轴线观察时,该更为球形形状的外层的每一端并不具有星形的支柱(如图20所示)。
内层100可以采用造影(如钽、铂或金)线作为网状物的一部分以增强在所述血管内的可视性。在如图19所示的另一示例中,造影标志物150可以用在沿外层120的选定位置以增强可视性。标志物150也可以用于图17所示的装置。
图21-22展示了根据本发明的血管塞的另一实施例。该实施例包含内部结构,其可以被视为类似于图17所示的实施例的所述外层120。取代内层100,该实施例在支撑结构120上采用膜160。在一示例中,所述膜160可以固定于支撑结构120。在另一示例中,所述膜16可以热固着在支撑结构120上。在另一示例中,胶粘剂可用于将膜160粘结至支撑结构120。在一示例中,所述膜160由聚合物构成。在一示例中,该聚合物可以是ePTFE。在另一示例中,可以使用聚酯、聚氨酯或PLGA。与图19所示相似的,造影标志物150可以设置在支撑结构120上以增强可视性。与图17所示的所述内层100相似的,所述膜160大体上防止了血液流入所述血管并且促进闭塞。
图23展示了根据本发明的血管塞的另一实施例。该实施例采用外部结构300、内部结构310(图23中不可见)以及夹在所述两个结构之间的膜320。在一示例中,所述内部和外部结构300、310为球形形状且包括网状物或编织物。所述编织物层的近端和远端可以连同造影标志物340卷在一起。在一示例中,所述标记物340为涂有钽的不锈钢。所述标记物340系在所述编织物的各端且当在部署时可以使得在所述血管内的装置可视。
在一示例中,所述远端标记卷曲采用一个用于所述内部结构310的标志物以及一用于所述外部结构300的单独的标志物,并且从而能够使所述两个结构彼此独立地展开。换句话说,这样一种配置将允许所述外部结构300在所述内部结构310展开之前进行展开。每个结构的展开程度将取决于每个结构的热记忆。
所述塞以折叠状态被送入并且一旦从所述导管被部署在部署后进行展开,并且允许根据内部编织物被打开的程度进行可变的扩散血流分布。换句话说,如果所述内部结构310并未完全展开,所述孔径尺寸小于所述内部结构310处于完全展开状态下的大小,从而所述塞在这样一种配置下实际上将更为闭塞。因此,在某些实施例中,所述内部和外部结构310、300相对于彼此独立且可控地可扩张。
所述膜320可以由聚合物构成。在一示例中,该聚合物为ePTFE。在另一示例中,可以使用聚酯、聚氨酯或PLGA。所述内部结构310为所述膜320提供了一个基础层,而所述外部结构300为所述膜320提供了增强的抑制力,同时也对血流提供了另一个屏障。在一示例中,所述膜320可粘接、热固着或系在任一所述内部或外部结构310、300或同时两个结构。在一示例中,所述内部和外部结构310、300由48根.0019英寸直径的线制成。在一示例中,造影线(即钽)编织成编织物以提供造影。所述结构310、300可以被热成型为需要的形状(如球形)。
在另一与图23所示的实施例相似的实施例中,未使用内部结构且所述膜320仅与所述外部结构300固定。这样一种固定能够通过胶粘剂,机械或通过热成型操作等达到。
图24说明了根据本发明的用于输送闭塞塞的输送***。所述输送***包括推杆200和连接部180。所述连接部180可分解以将所述塞从所述推杆200上切断。在一示例中,推杆200为推丝。在另一示例中,推杆200为海波管。机械的(如螺纹)、液压的、热分解的,或电解***可用于分解连接部180。可以使用一种如专利号为8182506的美国专利所示的分离***,现将其整体纳入参考。另一种能够被使用的分离***如专利号为6620152的美国专利所示,现将其整体纳入参考。所述装置可以通过导管输送并且在所述目标部位被分离。
在一实施例中,所述塞可折叠并且在所述导管内以收缩状输送,且一旦从所述导管被部署采用其扩大的部署形状。在另一实施例中,所述塞通过导管输送,该导管足够大到容纳处于部署形状的所述塞。如此,所述塞以其最终形状被输送并被部署。
对于采用膜的任一实施例,所述膜的孔径尺寸可根据所需的闭塞率定制。更小的孔径尺寸与更大的孔径尺寸的膜相比通常将更快地闭塞血流。因而如果需要快速的闭塞,使用更小孔径尺寸的膜,且如果需要较慢的闭塞,使用更大孔径尺寸的膜。可选地,所述结构的仅一部分覆盖有所述膜,例如,所述支撑结构的三分之一或一半覆盖有所述膜,这将导致闭塞花费更长的时间相比于所述结构的全部覆盖有所述膜。
相似地,对于采用内层100的任一实施例,所述内层100的孔径尺寸可根据所需的闭塞率定制。当需要快速的闭塞,对于所述内层100使用更小的孔径尺寸,并且当需要较慢的闭塞,对于所述内层100使用更大的孔径尺寸。
对于采用内层或结构100以及外层或结构120的以上所述的任一实施例,所述层的近端和远端可与造影或是非造影标志物一并卷起。在一示例中,所述造影标志物为涂有钽的不锈钢。这样的标志物用于系在或是绑在所述层的末端,并且如果是造影时,当在部署时允许在所述血管内的装置可视。所述内层或结构100的近端与所述外层或结构120的近端可以一同卷起或者彼此独立。同样的,所述内层或结构100的远端与所述外层或结构120的近端可以一同卷起或者彼此独立。在实施例中,所述内层或结构100的末端与所述外层或结构120独立卷曲,以使得所述内层或结构100与所述外层或结构120彼此独立展开。因此,根据所述层或结构的展开程度可以实现可变的扩散血流分布。例如,如果所述内层未完全展开,所述孔径尺寸将比所述内层处于完全展开状态下的孔径尺寸小并且因而实质上更为闭塞)。换句话说,在某些实施例中,所述内部和外部结构相对于彼此独立且可控地可扩张。
虽然本发明已被描述在特定的实施例和应用中,普通本领域技术人员在其教导的启发之下可以得到其他的实施例和修改,而不脱离请求保护的本发明的精神或是超越请求保护的本发明的范围。相应地,可以理解,文中所述的附图及说明所提供的示例的方式是为了帮助对发明的理解而不应被解释为对范围的限制。

Claims (13)

1.一种血管疾病治疗***,包括:
输送管;
与所述输送管的远端部分相联的容纳装置,所述容纳装置包括由适形材料制成的袋,该适形材料允许该袋采用灵活的形状;
推杆,其能远侧移动通过输送管的管腔,以将所述容纳装置从输送管的远端移出;
连接到推杆的远端的柱塞,该柱塞的直径大于推杆;以及
止动环,其固定在输送管的管腔的内表面上,与输送管的远端间隔开,该止动环防止推杆的远端被推进超过所述止动环,
其中,所述容纳装置初始至少部分地位于所述止动环的近端,并且所述推杆的远侧移动推动所述容纳装置向远侧通过止动环并从输送管移出。
2.根据权利要求1所述的***,其中,所述袋接收并保存栓塞剂。
3.根据权利要求1所述的***,其中所述推杆使容纳装置的近端躯干与柱塞接合。
4.根据权利要求1所述的***,其中,在输送管部署之前,所述容纳装置定位在输送管的远端部分附近。
5.根据权利要求1所述的***,其中,所述容纳装置具有网状结构。
6.根据权利要求1所述的***,其中,在所述容纳装置的尺寸满足将所述容纳装置设置于血管疾病的入口处中,所述血管疾病包括:动脉瘤、房间隔缺损、左心耳、以及卵圆孔未闭。
7.根据权利要求2所述的***,其中,所述栓塞剂包括以下至少一种:液体栓塞以及栓塞线圈。
8.一种用于闭塞血管部位的设备,包括:
导管;
推杆,其具有连接到推杆远端的柱塞,该柱塞的直径大于推杆;
止动环,其固定在导管的管腔的内表面上,与导管的远端间隔开,该止动环防止推杆的远端被推进超过所述止动环; 以及
闭塞保护装置,其定位在导管的管腔内,靠近所述导管的远端,所述闭塞保护装置具有非部署状态和部署状态;所述闭塞保护装置包括由适形材料制成的袋,该适形材料允许该袋采用灵活的形状,
其中,所述推杆的远侧移动推动所述闭塞保护装置向远侧通过止动环并从输送管移出。
9.根据权利要求8所述的设备,其中,所述闭塞保护装置接收并保存栓塞剂。
10.根据权利要求8所述的设备,其中,所述闭塞保护装置包括与柱塞抵接的躯干。
11.根据权利要求8所述的设备,其中,所述闭塞保护装置具有网状结构。
12.根据权利要求8所述的设备,其中,在所述闭塞保护装置的尺寸和形状满足将所述闭塞保护装置设置于血管疾病的入口处中,所述血管疾病包括:动脉瘤、房间隔缺损、左心耳、以及卵圆孔未闭。
13.根据权利要求9所述的设备,其中,所述栓塞剂包括以下至少一种:液体栓塞以及栓塞线圈。
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US10398441B2 (en) 2019-09-03
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