CN109862835B - 用于从血管中移除闭塞凝块的凝块收回系统 - Google Patents
用于从血管中移除闭塞凝块的凝块收回系统 Download PDFInfo
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- CN109862835B CN109862835B CN201780064234.4A CN201780064234A CN109862835B CN 109862835 B CN109862835 B CN 109862835B CN 201780064234 A CN201780064234 A CN 201780064234A CN 109862835 B CN109862835 B CN 109862835B
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Abstract
本发明提供了一种凝块捕获导管,所述凝块捕获导管包括伸长管轴,所述伸长管轴具有近侧端部、远侧端部和所述远侧端部处的可充气式可膨胀构件。所述可膨胀构件能够从塌缩输送构造充气成膨胀构造。在所述膨胀构造中,所述可膨胀构件膨胀以限定在所述导管的最远侧端部处具有扩大的远侧凝块进入管头的漏斗形状。在所述膨胀构造中,所述可膨胀构件可朝远侧延伸超过所述轴的最远侧末端。所述可膨胀构件可与所述导管轴的远侧末端成一体。
Description
技术领域
本发明涉及计划在牵涉到从血管中移除急性堵塞物的手术中使用的装置。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,便发生血栓栓塞。该凝块(现在称为栓塞)随后沿血流方向运送。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,该机制在形成冠状动脉堵塞中是常见的。本发明特别适用于涉及下列情况的病例中:从患有急性缺血性脑卒中(AIS)的患者的脑动脉、患有心肌梗塞(MI)的患者的冠状天生或移植血管和患有肺栓塞(PE)的患者的肺动脉以及凝块造成闭塞的其它外周动脉和静脉血管中移除凝块。
背景技术
最近的临床研究表明,对于最近患有急性缺血性脑卒中的患者,机械血栓切除术是一种恢复流向其缺血性组织的血流的非常有效的方法。该手术通常涉及将血栓切除装置(可为支架收回器和/或抽吸导管)推进至闭塞凝块,与凝块接合并将凝块缩回到局部抽吸导管或置于更近侧的引导件或护套的安全位置中。在后一种情况下,通常采用球囊引导导管,当使用此类导管时,可使球囊充气以限制流经导管的流量,以更容易地将所捕获的凝块安全地收回到导管管头中。通过球囊引导导管进行抽吸通常用于逆转远侧脉管系统中的流动,协助将所捕获的凝块传送到导管管头中。
然而,尽管球囊引导件提供了有益效果,但目前可用的装置存在显著的局限性:
这些局限性之一是由于球囊在导管上的位置。常规的球囊引导导管在球囊远侧具有“死空间”,这是由于球囊的远侧颈部附接到导管轴的方式以及远侧导管末端的存在所致。该死空间是凝块不易被抽吸或吸取的区域,因此如果凝块碎片卡在该区域中,则它们可在球囊放气(必须在从患者体中移除导管之前执行)时朝远侧逸出,从而可能导致血管阻塞并对患者造成严重伤害。
常规球囊引导导管的第二局限性是当凝块被抽回到导管中时在凝块中诱导产生的剪切应力水平。该应力受到多个因素的影响,包括凝块和导管腔的相对大小以及凝块相对于导管的摩擦系数。进入导管的凝块必须突然改变形状以符合导管的内径以便进入导管。该突然的变化可在凝块和导管末端之间的接触面处产生高剪切应力,这可使凝块剪切或撕裂,释放凝块碎片,这些凝块碎片随后会悬置在前述死空间中,或者使大部分或整个凝块从已将其收回到球囊引导导管的支架收回器或抽吸导管中移出。如果这些凝块部分或碎片随后未被完全抽吸到球囊引导导管中,则它们可朝远侧移动并造成损伤或死亡。
发明内容
本发明解决了先前描述的球囊引导导管的远侧末端处的凝块剪切和卡在“死空间”中的凝块碎片的问题。本发明的主题是被构造成用于机械血栓切除手术的导管,其包括具有可膨胀远侧末端部分的伸长管轴。
伸长轴包括第一内腔,其它导管或部件可穿过该第一内腔并且可通过该第一内腔抽吸凝块,还包括轴壁内的第二内腔,该第二内腔从导管的近侧毂延伸到轴的远侧端部处的可充气构件。该第二内腔的横剖面可为圆形的,或者可为长椭圆形的,并且可包括多个腔。
可膨胀远侧末端部分的一个实施方案包括漏斗形球囊,并且具有塌缩状态和膨胀状态。在塌缩状态下,球囊被放气并且可为褶曲的和/或打褶的,以使其剖面最小化,以便推进穿过导引器护套并穿过患者的脉管系统。在膨胀状态下,球囊被充气。球囊充气用于多个目的:
1)球囊可被充气至使其与脉管壁接触的直径,从而部分地或完全地阻止血流流过球囊。这继而可有助于减小在血栓切除手术期间部分或全部凝块被收回到导管中的可能性。这也有利于通过导管进行有效抽吸,确保该抽吸在远侧脉管中产生逆流。
2)球囊充气可有助于稳定脉管内的导管,防止导管意外移动及随之发生的脉管创伤。
3)本发明的球囊充气也会改变导管末端的形状,优化导管末端与被抽入其中的任何物质或装置之间的接触面的几何形状。具体地讲,该形状变化减小了当血栓物质被抽入导管中时施加在血栓物质上的剪切力,并且最小化或消除了可能困住血栓的任何“死空间”或槽腔。
在本发明的一个实施方案中,漏斗形球囊与远侧导管末端部分成一体,并且由一段聚合物管形成,该聚合物管被倒转,使得球囊和导管之间的远侧结合部位于球囊自身的下方(和内部)。
球囊壁厚可被压型/渐缩,以迫使球囊在某些区域比在其它区域优先膨胀更多,从而使得在充气时能够得到漏斗形剖面。在一个实施方案中,球囊的近侧部分和远侧部分的壁厚大于中间段的壁厚。在另一实施方案中,球囊的近侧部分的壁厚大于中间段和远侧段的壁厚。
在另一实施方案中,球囊的近侧部分被增强,以在充气时限制其膨胀,从而使得球囊的远侧部分优先膨胀并在远侧端部处形成球根状漏斗形状。该增强物可以以肋的形式,这些肋可沿球囊轴向或径向延伸,并且/或者可由与球囊自身相同或不同的材料形成。
倒转的球囊可被定位成使其悬于导管末端之上,在该情况下,球囊材料在未膨胀状态下不受任何轴向拉力,这与大多数常规的柔性球囊不同。该轴向拉力的缺乏加上悬垂度(理想地大于0.5mm但小于3.5mm)是确保球囊可被充气成漏斗状形状的关键。
在组装到导管轴上之前,球囊可预先成形为漏斗状形状,在该情况下可能有利的是,也在其上设置皱褶或优选折纹,以有利于有效地向下卷绕成低剖面。
在一系列实施方案中,在导管轴上采用多个球囊。这样做的好处是,允许针对特定任务定制单独的球囊性质。例如,低压柔性球囊可被设计成封住脉管壁以帮助形成流动阻滞,而另一球囊可被设计成在远侧导管末端处采用漏斗状形状,以使凝块上的剪切力最小化并且有利于大的和/或坚固的凝块容易进入导管管头中。在一些情况下,可采用更高压力、更小柔性的球囊来帮助防止导管末端过于靠近脉管壁及妨碍凝块收回。
必须仔细选择用于该导管构造中的材料。对于高压球囊,相对高模量的材料诸如PET或聚酰胺均为不错的选择,但是对于本发明的导管的某些可充气部分,需要更柔软、更柔性的材料。这优选包括无定形弹性体聚合物,使得其可在充气压力下拉伸/应变至其未充气直径的至少两倍和多达5倍,并且在放气时恢复其大部分或全部未膨胀形状。这要求材料承受至少200%且理想地500%或更多的弹性应变,具有最小程度的塑性变形。聚合物链的交联大大有利于此类高水平的可复原应变,因此热固性材料诸如硅橡胶可能是用于柔性球囊的不错选择。然而,硅酮不是一种易于接合到第二材料的材料,因为其不易熔化并且不易与另一材料混溶以形成例如牢固且低剖面的焊接接头。出于这一原因,聚氨酯弹性体为用于本发明的球囊的优选材料。尤其是热塑性聚氨酯弹性体会成为理想的材料,因为其可作为焊接或接合工艺的一部分被熔化,或者可采用溶剂粘合或以粘结方式粘合。此外,此类聚氨酯可接合到相容的材料族,以沿导管长度形成比仅限于聚氨酯时可能产生的刚度梯度更大的刚度梯度。例如,非常柔软的聚氨酯可用于导管的球囊和极远侧段;一种或多种Pebax(聚醚嵌段酰胺共聚物)材料可用于导管的中间段;并且聚酰胺材料可用于导管轴的近侧段。该系列材料提供越来越高的硬度和杨氏模量(或刚度),使得非常柔性的远侧轴区域可以平滑地过渡到更硬的近侧轴区域。聚醚嵌段酰胺材料具有可与聚氨酯和聚酰胺两者接合的优点,虽然聚氨酯和聚酰胺不易彼此接合。
在一个方面,本发明提供了包括伸长管轴的凝块捕获导管,该伸长管轴具有近侧端部、远侧端部和远侧端部处的可充气式可膨胀构件,该可膨胀构件能够从塌缩输送构造充气成膨胀构造,其中在膨胀构造中,可膨胀构件延伸到至少轴的最远侧末端,并且在轴的最远侧末端处从轴径向向外延伸,以限定管头。
在一个方面,本发明提供了包括伸长管轴的凝块捕获导管,该伸长管轴具有近侧端部、远侧端部和远侧端部处的可充气式可膨胀构件,该可膨胀构件能够从塌缩输送构造充气成膨胀构造,其中在膨胀构造中,可膨胀构件在导管的最远侧末端处径向向外延伸,以限定具有扩大的远侧凝块进入管头的漏斗形剖面。
在一个实施方案中,在膨胀构造中,由可膨胀构件限定的导管的最远侧部分的直径大于导管的远侧区域的大致圆柱形内腔的直径。
在一种情况下,在膨胀构造中,可膨胀构件朝远侧延伸超过轴的最远侧末端。
在一个实施方案中,可膨胀构件包括球囊。在膨胀构造中,球囊可为具有扩大的远侧进入管头和更窄的近侧端部的漏斗形状。
在一种情况下,球囊与导管轴的远侧末端成一体。
可膨胀构件由聚合物管形成,该聚合物管被倒转,使得球囊和导管轴之间的远侧结合部位于球囊内。
在一个实施方案中,球囊包括彼此具有不同性质的区域。
球囊可包括近侧区域、远侧区域以及近侧区域和远侧区域之间的中间区域,并且其中在膨胀构造中,远侧区域比近侧区域膨胀至更大程度。
在一种情况下,至少一个区域具有与至少一个其它区域不同的壁厚。
在一种情况下,近侧区域和远侧区域的壁厚大于中间区域的壁厚。
在一个实施方案中,近侧区域的壁厚大于中间区域和远侧区域的壁厚。
在一种情况下,可膨胀构件包括近侧颈部和远侧颈部,近侧颈部具有第一厚度并且连接到在导管远侧端部的近侧的导管轴,可膨胀构件的近侧部分包括第二厚度,可膨胀构件的远侧部分包括第三厚度,并且倒转并接合到导管轴远侧端部的远侧颈部包括第四厚度。
在一个实施方案中,可膨胀构件的中间部分包括从第二厚度逐渐减小到第三厚度的可变厚度。
在一种情况下,第一厚度大于第二厚度,并且第二厚度大于第三厚度。
在一个实施方案中,第四厚度大于第三厚度。
在一种情况下,第四厚度大于第三厚度。
在一个实施方案中,第一厚度与放气状态下的第二厚度大致相同,但是大于充气状态下的第二厚度。
在一种情况下,在可膨胀构件的近侧区域和远侧区域之间设置有带,该带具有比近侧区域和/或远侧区域的壁厚更大的壁厚,以形成相对不可膨胀的区域,使得可膨胀构件优先在带的近侧和远侧充气,以提供漏斗形剖面。
在一种情况下,增强区域中的至少一个区域,以限制该区域的膨胀。
在一个实施方案中,近侧区域包括增强物。
在一种情况下,增强物包括肋。
肋可沿近侧区域的至少一部分轴向和/或径向延伸。
在一个实施方案中,肋的材料与球囊的材料相同或不同。
在一种情况下,塌缩构造中的可膨胀构件延伸超出导管轴的远侧末端。
可膨胀构件延伸超出导管轴的远侧末端达0.5mm至3.5mm的距离。
在一个实施方案中,导管轴包括主内腔和用于使可膨胀构件充气的充气腔。
充气腔可在导管轴的壁内延伸。
在一种情况下,充气腔和导管腔是偏心的。
在另一情况下,充气腔和导管腔是同心的。
在一种情况下,可充气式可膨胀构件包括无定形弹性体聚合物。
弹性体聚合物可为热塑性聚氨酯弹性体。
在一个实施方案中,导管的轴的一部分包括可充气式可膨胀构件。
在一种情况下,导管轴的远侧区域包括无定形弹性体聚合物。
在一个实施方案中,导管的远侧区域的无定形弹性体聚合物为热塑性聚氨酯弹性体。
在一种情况下,轴的远侧部分包括第一无定形弹性体聚合物,并且可充气式可膨胀构件包括不同于第一无定形弹性体聚合物的第二无定形弹性体聚合物。
在一个实施方案中,导管轴包括近侧区域、远侧区域以及近侧区域和远侧区域之间的中间区域,并且其中轴的近侧区域、中间区域和远侧区域包括具有不同刚度的材料。
在一种情况下,导管轴的近侧区域包含聚酰胺,远侧区域包括热塑性聚氨酯弹性体,并且中间区域包括聚醚嵌段酰胺共聚物。
在一种情况下,导管还包括在可膨胀构件处或邻近所述可膨胀构件的可膨胀标记物带。
在一个实施方案中,远侧标记物带位于可膨胀构件下方。
在一种情况下,不透射线的远侧标记物为具有轴向延伸狭槽的大致管状形状,所述狭槽被构造成有利于标记物膨胀。
在一个实施方案中,凝块捕获导管包括两个至更多个可膨胀构件。
在另一实施方案中,至少一些可膨胀构件具有不同的柔度。
在一种情况下,凝块捕获导管包括安装在导管的远侧段上的可膨胀球囊构件,该球囊构件包括定位在外球囊内的内球囊构件。
在一个实施方案中,球囊构件的弹性柔度是不同的。
在一种情况下,仅内球囊与充气腔连通有利于膨胀。
在一个实施方案中,内球囊被构造成在膨胀时接触外球囊。
在一种情况下,在膨胀构造中,可膨胀构件的最远侧部分的有效直径比导管轴远侧端部处内腔的直径大至少20%。
在另一情况下,有效直径比导管轴远侧端部处内腔的直径大至少30%、至少40%、至少50%、至少60%、至少70%、至少80%、至少90%或至少100%。
在一个实施方案中,可膨胀构件的远侧末端区域以张角从导管轴腔朝外张开。
在一种情况下,张角为10度至60度或15度至45度。
在一个实施方案中,可膨胀构件包括特征部诸如起伏部和/或弯折部以有助于远侧末端区域的张开。
在一种情况下,可充气构件被倒转并在近侧接合区域处接合到导管轴,其中该轴包括多个层,该多个层包括外套管、中间层、内衬和增强编织物或线圈。
在一个实施方案中,可充气构件的近侧端部在近侧接合区域处接合到伸长轴,并且可充气构件的另一端被倒转并在结合部处接合到中间层,使得形成可膨胀构件的大致管状聚合物构件的中间段被定位在导管的远侧端部处,并且位于结合部和中间段之间的管状聚合物构件的部分接合到导管轴的远侧段上。
在一种情况下,将材料条带安装在可膨胀构件上并朝近侧接合到导管主体,并且将材料条带的远侧端部粘结到无创伤远侧导管末端。
在一个实施方案中,多个材料条带径向地围绕球囊定位。
在一种情况下,材料条带包括低弹性柔度聚合物诸如PET。
在一个实施方案中,可膨胀元件为复合构造,该复合构造包括散布有弹性可膨胀材料的段的半刚性肋。
在一种情况下,肋平行于导管的轴线延伸。肋可以以螺旋构造延伸。
在一个实施方案中,导管包括密封的充气腔室,该充气腔室适于填充不透射线流体。
在一种情况下,凝块捕获导管包括用于使可膨胀构件充气以及使可膨胀构件放气的柱塞。
在另一情况下,凝块捕获导管包括用于移动柱塞来控制可膨胀构件的充气和放气的控制器。
控制器可包括手动旋钮。
在一个实施方案中,柱塞由波纹体限定。
在一种情况下,凝块捕获导管包括弹簧以偏置波纹体的移动。
在一个实施方案中,膨胀构造中的可膨胀构件的远侧末端的剖面为非均匀形状。
在一种情况下,剖面包括椭圆。
在一个实施方案中,套件包括凝块捕获导管、凝块接合装置和用于凝块接合装置的微导管。
凝块接合装置为支架收回器装置。
在另一方面,本发明提供了凝块捕获程序,包括:-
提供在导管的最远侧末端处具有可充气构件的凝块捕获导管;
在可充气构件处于塌缩构造时,朝凝块推进凝块捕获导管;
在导管的远侧末端处使可充气构件充气,使得可充气构件从导管的最远侧末端向外延伸到脉管壁;将凝块抽到导管中;
使可充气构件放气;以及
抽回导管。
在一种情况下,该方法包括抽吸以将凝块抽入导管中。另选地或除此之外,该方法包括将凝块与机械装置诸如支架收回器接合,以将凝块抽入导管中。
在一个实施方案中,凝块捕获程序包括提供微导管,推进微导管穿过凝块捕获导管,以及从导管展开凝块接合装置。
在另一方面,本发明提供了用于捕获凝块的方法,包括:-
推进导管穿过脉管系统到达在脉管中目标凝块近侧的位置;
用微导管穿过凝块;
推进凝块捕获装置穿过微导管到达凝块位点;
缩回微导管,以至少部分地在凝块下方展开凝块捕获装置;
使导管的可膨胀构件充气以减缓或阻止脉管中的流动;朝向导管朝近侧缩回凝块捕获装置;
将注射器或泵连接到导管的近侧端部并进行抽吸以逆转脉管中的血流;
在抽吸下将凝块捕获装置和所捕获的凝块缩回到导管的管头中;
在抽吸下继续缩回凝块捕获装置,使其穿过并离开导管;以及
停止抽吸并使可膨胀构件放气以恢复到脉管的血流。
附图说明
参考附图,根据下文对本发明仅以举例的方式给出的一些实施方案的描述,将更清楚地理解本发明,其中:
图1为本发明的凝块收回导管的等轴视图;
图2a至图2d为通过本发明的凝块收回导管的轴所取的剖视图;
图3a至图3e为通过本发明的凝块收回导管的轴和轴的部分所取的剖视图;
图4为示出了一种导管轴制造方法的侧视图;
图5为本发明的凝块收回导管的远侧部分的剖视图;
图6a至图6b为本发明的凝块收回导管的远侧部分的剖视图;
图7a至图7c为本发明的凝块收回导管的远侧部分的剖视图;
图8a至图8c为本发明的凝块收回导管的远侧部分的剖视图;
图9a至图9d为常规现有技术血栓切除手术的视图;
图10a至图10d为采用本发明的凝块收回导管的血栓切除手术的视图;
图11为本发明的凝块收回导管的远侧部分的剖视图;
图12为本发明的凝块收回导管的远侧部分的剖视图;
图13为本发明的凝块收回导管的远侧部分的剖视图;
图14为本发明的凝块收回导管的远侧部分的剖视图;
图15为本发明的凝块收回导管的远侧部分的剖视图;
图16a至图16c为本发明的凝块收回导管的远侧部分的剖视图;
图16d为本发明的凝块收回导管的远侧部分的侧视图;
图16e至图16f为本发明的一个可膨胀标记物带的视图;
图16h至图16i为本发明的另一可膨胀标记物带的视图;
图17a至图17b为本发明的凝块收回导管的远侧部分的剖视图;
图17c为图17a和17b的导管的远侧端部的等轴视图;
图18a为本发明的凝块收回导管的远侧部分的简化视图;
图18b为沿图18a中的线A-A所取的横剖面视图;
图18c至图18d为通过本发明的凝块收回导管的远侧部分所取的剖视图;
图19a至图19b为本发明的凝块收回导管的近侧毂的视图;
图20a和图20b为本发明的凝块收回导管的远侧端部的等轴视图;并且
图20c为在使用中的本发明的凝块收回导管的简化视图。
详细描述
现在参考附图详细描述本发明的具体实施方案,其中相同的参考标号表示相同或功能性相似的元件。术语“远侧”或“近侧”在以下关于相对于治疗医师的位置或方向的描述中使用。“远侧”或“朝远侧”是离医师远的位置或远离医师的方向。“近侧”或“朝近侧”或“接近”是离医师近的位置或朝向医师的方向。
进入脑血管、冠状血管和肺血管涉及使用许多可商购获得的产品和常规的程序步骤。进入产品诸如导丝、诊断导管、微导管在别处描述,并且常用于导管实验室程序中。在下文的描述中假定这些产品和方法与本发明的装置和方法结合使用,并且不需要详细描述。
以下具体实施方式本质上仅仅是示例性的,并不旨在限制本发明或本发明的应用和用途。虽然本发明的描述在许多情况下是在治疗颅内动脉的情况下进行的,但本发明也可用于如前文所述的其它身体通道中。
图1中,附图标号100示出了本发明的凝块捕获导管,其包括附接到远侧轴102的远侧可充气部分101,该远侧轴继而附接到轴中间段103,该轴中间段附接到轴近侧段104。近侧毂105连接到导管轴的近侧端部并且包括鲁尔附接件106和侧口107。侧口107提供通向充气腔的通路,该充气腔从毂穿过导管轴的壁到可充气部分101。充气腔示出于图2中所示轴的剖视图中。
远侧末端的可充气部分101优选包括无定形弹性体聚合物,使得其可在充气压力下拉伸/应变至其未充气直径的至少两倍和多达5倍,并且在放气时恢复其大部分或全部未膨胀形状。这要求材料承受至少200%且理想地500%或更多的弹性应变,理想地具有最小程度的塑性变形或滞后。聚合物链的交联大大有利于此类高水平的可复原应变,因此热固性材料诸如硅橡胶可能是不错的选择。然而,硅酮不是一种易于接合到第二材料的材料,因为其不易熔化并且不易与另一材料混溶以形成例如牢固且低剖面的焊接接头。出于这一原因,聚氨酯弹性体也是适用于本发明的球囊的材料。尤其是热塑性聚氨酯弹性体会成为理想的材料,因为它们可作为焊接或接合工艺的一部分被熔化,或者可采用溶剂粘合或以粘结方式粘合。
图2a至图2d示出了通过图1的导管的轴的各种实施方案所取的多个可能的剖视图,如图1中的剖面线108中所示。图2a示出了具有内腔152和单个充气腔151的轴150。图2b示出了具有内腔162和三个充气腔161的轴160。图2c示出了具有内腔172和单个长椭圆形新月形充气腔171的轴170。图2d示出了具有外轴壁184、内轴壁183和内部腔182的轴180。内轴壁和外轴壁之间的空间形成充气腔181。在所有这些轴变型中,轴构造还可包括内腔壁上的低摩擦涂层或衬里(诸如PTFE)。增强编织物和/或线圈线材或纤维可用于提供环向强度(以承受通过内腔抽吸而不塌缩)和抗扭结性。轴的主壁可包括一种或多种材料,其中热塑性聚合物诸如聚氨酯、Pebax和聚酰胺为首选示例。在优选轴材料构造的一个示例中,一个或多个等级的聚氨酯用于球囊和导管的极远侧段;一种或多种Pebax(聚醚嵌段酰胺共聚物)材料用于导管的中间段;并且一种或多种聚酰胺材料用于导管轴的近侧段。该系列材料提供越来越高的硬度和杨氏模量(或刚度),使得非常柔性的远侧轴区域可以平滑地过渡到更硬的近侧轴区域。聚醚嵌段酰胺材料具有可与聚氨酯和聚酰胺两者接合的优点,虽然聚氨酯和聚酰胺不易彼此接合。
充气腔可以以后文所述的多种不同方式形成,并且可衬有熔点或软化点均高于轴主壁的一种或多种材料(诸如PTFE、FEP、PET或聚酰亚胺),以便有利于形成充气腔以及随后移除在该工艺中使用的任何成形芯轴。如图2a至图2c中所示,轴可设计成偏心的,以提供足够的壁厚进而在不造成导管总直径过大的情况下形成充气腔。另选地,可采用同心设计,诸如图2d中所示。
图3a至图3e示出了通过本发明的凝块收回导管的轴的部分所取的一系列剖视图,示出了可如何形成充气腔的一个实施方案。在该实施方案中,图3a中的伸长管200配有三根芯轴线201,使该管变形成如图3b中所示的长椭圆形形状。然后将管200和线201的组件放置在伸长轴203的顶部上,并且将外护套202放置在两者上方,如图3c中所示。随后如由线204所示施加热量和压力(任选地通过另一外护套或热缩调节,未示出),以将整个组件层压在一起。该工艺将外护套202熔合至内伸长轴203并且用其内芯轴线201围绕充气腔管200,如图3d中所示。芯轴用于在该成形工艺中防止充气腔塌缩并保持其所需形状。一旦完成成形工艺,就将芯轴移除,从而使充气腔206打开并且不被阻挡穿过复合轴205,如图3e中所示。该设计和工艺的许多变型是可能的,例如充气管可由低摩擦材料诸如PTFE制成,在该情况下,其可在移除芯轴线时留在原位,或者其可与芯轴线一起或者在芯轴线之后自行移除。在另一实施方案中,充气管通过溶液浇铸制成,并且包括聚酰亚胺或其它相对高模量的材料,其可被制造成小至0.001或更低的壁厚并且仍然保持高度的结构完整性。将聚酰亚胺作为材料选择的另一优点是其不会在导管成形/熔合工艺中熔化,从而最大限度地减少了最后移除芯轴的挑战。芯轴自身可为金属的或者由非常高张力的聚合物形成,并且理想地涂覆有低摩擦材料,诸如PTFE或聚对二甲苯。
图4示出了本发明的导管轴的优选制造方法。具有不同硬度和/或弹性模量的两段聚合物管(251和252)之间的接触面被示出为通过涉及外部热缩管252和热源253的热成形工艺及压力成形工艺在沿轴长度的点处接合在一起。导管轴沿其大部分长度需要具有刚度梯度,以从刚性且可推动的近侧端部无缝过渡到高度柔性且无创伤的远侧端部。该刚度梯度不需为突变的,这可能成为两种轴材料之间的结合部的问题。如区域254中所示,将待接合的管的端部羽化使得从第一材料250到第二材料251实现更渐进的刚度过渡。以该方式,相较于在简单对接中产生的最小材料混合量可能实现的长度,轴的给定横剖面中的每种材料的%可以在更大的长度上变化。如果需要,所示构造使得重叠区域254能够延伸到长度大于10mm,但是重叠长度优选介于1mm和5mm之间。
图5示出了类似于图1中所示导管100的凝块收回导管300的远侧端部的剖面侧视图。导管包括基本上圆柱形的伸长管轴302,可充气远侧球囊301安装到该管轴上。远侧球囊301被构造成使得在膨胀时形成漏斗形剖面。该漏斗形剖面可通过形成球囊的可膨胀膜的位置和壁厚剖面来实现,并且/或者可通过使用附加元件帮助扩张导管末端来实现,如本文档其它地方更详细说明的。线303表示导管末端区域的中心线。线305和线306为平行于中心线303的线,指示导管的最远侧面处的开口的直径311。点309和点310指示线305和线306与远侧面304相交的位置,表示导管远侧端部的开口直径的范围。线307和线308为平行于中心线303的线,指示导管内腔的直径312,凝块最终必须被挤入导管中,以通过导管将其完全移除。
该剖面的关键特征为,导管的最远侧部分的有效直径311显著大于导管远侧区域的大致圆柱形内腔的直径312。常规凝块收回导管的远侧末端可具有一些倒圆或倒角以形成非常小的引入端,但是这对于降低凝块上的剪切应力以及避免碎片丢失影响极小。所公开的本发明形成了真正的漏斗形状,而不需要拉线或其它此类刚性且笨重的机械致动。所形成的漏斗使得直径311理想地大于直径312至少20%,并且优选大于直径312达50%或100%。因此,如果直径312为0.084”(该类型的典型导管可能是这种情况),则直径311为至少0.101”并且理想地多达0.126”或0.168”或更大。
可充气构件301的壁厚剖面非常类似于图7b的可充气构件400的壁厚剖面,并且可参考其中提供的描述。
图6a和图6b分别示出了在充气状态和未充气状态下本发明的凝块收回导管的远侧区域的简化剖视图。导管包括具有内衬323、远侧末端段326和可充气部分328的伸长轴320。可充气部分328在不同区域中具有不同的壁厚,以在充气时产生所需的形状和效果。低壁厚区域321经受最高应变,因此在充气时膨胀最大,形成可用于限制或防止血流通过导管的球囊样形状。高壁厚区域322在相同的应力(和压力)水平下经受低得多的应变,因此不能膨胀至与更低壁厚区域相同的直径,然而它因充气构件内的压力而处于轴向拉力下,并且该拉力继续拉且有助于使末端段326张开至张角330。张角330优选介于10度和60度之间,最优选介于15度和45度之间。薄壁厚区域327起到铰链的作用,以使末端张开的阻力最小化。还可向该区域提供另外的特征部诸如弯折部或起伏部以有助于末端张开,图16提供了该情况的示例。可在区域329处设置另外的薄壁铰链(未示出),以有助于末端区域张开成漏斗状形状。标记物带324示出于可充气部分的下方,其用于双重目的:在荧光镜透视下为导管末端提供可见性,并且向导管轴提供环向强度以防止在充气压力下发生变形。
图7a至图7c示出了通过本发明的凝块收回导管的远侧部分所取的简化剖视图,示出了改变导管的可充气部分的壁厚剖面可如何用以影响充气球囊的形状。
在图7a中,可充气构件354的近侧颈部351包括第一厚度,并且在导管远侧端部的近侧连接到导管轴350。可充气构件的近侧部分352包括第二厚度,而远侧部分353包括第三厚度,并且倒转并接合到导管轴350远侧端部的远侧颈部355包括第四厚度。可充气构件354的中间部分356包括从第二厚度352逐渐减小到第三厚度353的可变厚度。在一个实施方案中,第一厚度大于第二厚度,并且第二厚度大于第三厚度。在一个实施方案中,第四厚度大于第三厚度。在一个实施方案中,第四厚度大于第一厚度。在一个实施方案中,第一厚度通常等于放气状态下的第二厚度,但是大于充气状态下的第二厚度。可充气构件的远侧段的该更薄剖面使得该段优先充气并朝远侧膨胀,形成所需的漏斗形状横剖面。然而,此类剖面充气过量可致使远侧段356撞击导管腔,这个问题可由图7b中和本文档中其它地方所示的剖面来解决。
图7b示出了本发明的凝块收回导管的远侧部分的另一实施方案,其具有略微不同的壁厚剖面。在该情况下,可充气构件400的近侧401和远侧403部分的壁厚大于中间402部分的壁厚。可充气构件的中间段的该更薄剖面使该段优先径向充气,使得近侧段和远侧段产生轴向应变。该轴向应变使远侧部分403提升并张开,形成所需的漏斗形剖面。
图7c示出了本发明的凝块收回导管的远侧部分的另一实施方案,其具有略微不同的壁厚剖面。在该情况下,具有更大壁厚的带451设置在球囊450的近侧区域和远侧区域之间,以形成相对不可膨胀的区域451,迫使球囊优先在该带的近侧和远侧充气,从而形成远侧“凸起”452并因此形成所需的漏斗形剖面。
在这些实施方案中的每个实施方案中,更薄壁段的壁厚在充气时比更厚壁段的壁厚减小更大的%,这使得未充气的壁厚能够用于控制可充气构件的充气形状。
图8a至图8c示出了通过本发明的凝块收回导管的远侧部分围绕中心线502所取的局部剖视图,示出了可如何使用倒转构件(管状或其它)来形成导管的可充气构件的示例。
图8a示出了可充气构件500,其在近侧接合区域507处接合到伸长轴501。轴501包括多个层,该多个层包括外套管510、中间层503、内衬505和增强编织物或线圈504。轴501还包括如其它地方所描述的内部充气腔(未示出)。可充气构件500、导管外套管510和导管中间层503优选全部由同族材料(诸如聚氨酯)制成,或者至少由具有相容组分的材料制成,使得它们可通过热量和压力或溶剂粘合工艺接合在一起。可充气构件500的近侧端部在近侧接合区域507处接合到伸长轴501,而可充气构件500的另一端倒转并在结合部508处接合到中间层503。因此,形成可充气构件500的大致管状聚合物构件511的中间段被定位在导管的远侧端部处,并且位于结合部508和中间段之间的管状聚合物构件511的部分509被层压到导管轴(包括内衬和增强编织物或线圈)的远侧段上。
图8b示出了与图8a中所示非常类似的构造,不同的是在该情况下,可充气构件550具有更短的倒转长度,并且轴501的中间层503基本上延伸到导管衬里和编织物的远侧端部。因此,可以使可充气构件550的倒转部分与轴之间的结合部508更靠近导管的远侧端部。
图8c示出了与图8a中所示非常类似的构造,不同的是在该情况下,可充气构件600由轴501的中间层503的延伸的倒转部分形成。
图9a至图9d(现有技术)示出了常规球囊引导导管技术存在的巨大问题之一,其可在凝块收回程序中对患者造成严重伤害。
图9a示出了凝块收回装置诸如支架收回器701,其通过脉管700将凝块或血栓702收回到球囊引导导管703的远侧管头705中。球囊引导导管703包括恰好定位在其远侧末端部分710近侧的球囊704。涉及支架收回器的典型血栓切除手术包括:
·使用常规血管内进入技术推进球囊引导导管703(或类似引导件或护套)穿过脉管系统到达目标凝块近侧的位置;
·通常借助导丝,用微导管穿过凝块;
·推进支架收回器穿过微导管到达凝块位点;
·缩回微导管,以至少部分地在凝块下方展开支架收回器;
·使球囊引导导管703的球囊704充气,以减缓或阻止脉管700中的流动;
·朝向球囊引导导管朝近侧缩回支架收回器;
·将注射器或泵连接到球囊引导导管703的近侧端部并抽吸以逆转脉管700中的血流;
·在抽吸下将支架收回器和所捕获的凝块缩回到球囊引导导管703的管头705中;
·在抽吸下继续缩回支架收回器,使其穿过并离开球囊引导导管703;
·停止抽吸并使球囊704放气以恢复到脉管700的血流。
图9a示出了该程序的阶段,其中支架收回器701和凝块702将被抽回到球囊引导导管703的管头710中。球囊704被充气并且操作者已开始通过球囊引导导管703抽吸,以逆转脉管700中的血流并有助于将凝块安全地抽回到导管的管头710中。然而,因为末端710在球囊704的远侧端部朝远侧延伸,所以恰好在球囊704远侧的远侧末端710周围存在死空间706。其中很少或没有逆流将凝块或任何凝块碎片拉入导管管头中。
图9b示出了上述程序的阶段,其中支架收回器701和凝块702正被抽回到球囊引导导管703的管头710中。当凝块被拉入导管中时,它必须变形成一定形状,以配合装入导管腔中。所需的变形程度取决于凝块和导管腔的相对大小,还取决于支架收回器抵靠导管压缩凝块的程度。更大程度的变形会在凝块上产生更高水平的剪切应力,其通常集中在导管的末端处,因为凝块在此处发生形状突变。这可使凝块撕裂并释放碎片,尤其是如果凝块不具有非常有组织的纤维蛋白结构以及/或者如果已向患者提供溶解药物诸如tPa。在该情况下,凝块碎片707和708已从凝块释放并位于死空间706中,并且凝块上的剪切应力诱导产生悬伸区域709,该悬伸区域被推到导管的远侧管头705的近侧并且存在脱离凝块主体撕裂的风险。
图9c示出了先前描述的高剪切力与死空间706结合的结果:图9b中所示的凝块碎片707和708已由第三碎片709接合,并且由抽吸诱导产生的穿过脉管进入导管的逆流未能将它们拉出死空间及进入导管管头。
图9d示出了从导管703内移除支架收回器701和任何所捕获凝块之后程序中的稍后阶段。在该阶段,停止通过导管抽吸,并且使球囊704放气。这使得到导管远侧的脉管700的血流恢复,因此凝块碎片707、708和709被释放并向下游流动,在那里它们可能阻塞一个或多个脉管,可能对患者造成严重伤害甚至死亡。
任何合适的凝块捕获装置均可用作本文所述的套件和程序的一部分。凝块捕获装置可为支架收回器类型。凝块捕获装置可以如我们的WO2012/120490A、WO2014/139845A、WO2016/083472A和/或WO2017/089424A中任一项所述。
图10a至图10d示出了与图9a至图d中所示类似的血栓切除手术,但这次采用了本发明的凝块收回导管803。执行与上述相同的程序步骤,但是因为导管803具有以下两个优点:1)球囊远侧的死空间很少或者没有;2)远侧管头张开以使凝块上的剪切应力最小化,所以在该情况下,凝块被完全收回到导管中,并且在球囊放气时不会丢失凝块碎片。
图10a示出了凝块收回装置诸如支架收回器801,其通过脉管800将凝块或血栓802收回到凝块收回导管803的远侧管头805中。凝块收回导管803包括定位在其远侧端部处的球囊804。如上文参考图9a至图d所述,球囊804已被充气以限制脉管800中的流动,并且可采用通过导管803抽吸来通过逆转脉管800中的血流来进一步帮助凝块进入导管管头805。
图10b示出了上述程序的阶段,其中支架收回器801和凝块802正被抽回到导管803的管头805中。导管803的漏斗形剖面806可最大限度地减小凝块被抽回导管中时在凝块中诱导产生的剪切应力,并且在球囊和末端之间,少有或没有死空间来在其内困住所产生或以其它方式存在的任何碎片(诸如所示碎片807)。
图10c示出了没有死空间的益处,即在拉回支架收回器801和凝块802的主体之后,再通过导管的抽吸和逆流将碎片807安全地拉到导管腔中。
图10d示出了从导管803内移除支架收回器801和所捕获凝块802之后程序中的稍后阶段。在该阶段,停止通过导管抽吸,并且使球囊804放气。这使得到导管远侧的脉管800的血流恢复,安全地恢复到远侧脉管系统的含氧血而不释放任何有害的凝块碎片。
图11示出了本发明的实施方案900,其示出了凝块捕获导管的远侧端部的部分剖面。两个可充气球囊构件902和906安装在导管905的远侧段上,其中一个球囊构件906定位在外球囊902内。一个或两个可膨胀球囊构件可与充气腔连通,以允许流体注入球囊中,从而使其膨胀。两个可膨胀构件的弹性柔度可随着球囊902的柔度低于球囊906的柔度而变化,反之亦然。在一种情况下,仅球囊906与充气腔连通有利于膨胀。当该球囊906膨胀时,它阻塞了其展开处的动脉或脉管,以提高抽吸并将凝块缩回到导管中的效力。此外,当球囊906膨胀时,它接触球囊902,迫使其膨胀并增加直径。球囊902的柔度确保随着直径增加,球囊的长度缩短,这样就将导管904的远侧末端拉成有利于收回凝块的漏斗形状。球囊902和远侧末端904之间的结合部903被定位在导管的远侧末端处或附近,以有利于形成漏斗形状。从周向到平行于导管轴线的纵向,这些球囊中的一者或两者的柔度可不同。当在压力下通过充气腔注入流体时,这将有利于在一个方向上优先膨胀。
图12示出了本发明的另一实施方案920,其中多个可膨胀球囊安装在导管上。该图也是局部剖视图,并且在该实施方案中,可膨胀构件922安装在导管924的远侧末端处。远侧可膨胀构件922形成引入端形状921,以有利于将凝块收回到导管中。将多个球囊或可膨胀构件安装在导管上允许可膨胀球囊的功能分离并且允许不同的可膨胀元件满足不同的性能属性。例如在该情况下,远侧球囊922有利于收回凝块,并且可在球囊923阻塞脉管并提供流动阻滞时将导管末端集中在脉管中。因此,远侧球囊922的直径可小于导管在其中展开的脉管,并且可为“不柔性的”或低柔度球囊,而定位于更近侧的球囊923可为直径大于脉管的软质柔性球囊,以提供无创伤脉管阻塞。沿导管轴线的球囊之间的距离可在2mm至150mm之间变化,并且在优选实施方案中,在2cm至10cm之间变化。由于远侧球囊具有比脉管小的直径,因此可将其充气至更高压力,而不会对脉管造成任何可膨胀的应变。该更高的压力可带来益处,即将导管末端部分地集中在脉管中。对在导管末端的近侧提供流动阻滞的球囊923进行定位有利于设计导管,使得该球囊定位在比远侧末端的位置更合适的脉管段中,例如,具有增加的骨支撑或外部支撑的脉管段。另选地,近侧球囊可定位在颈内动脉的近侧段中,或甚至定位在颈总动脉中。
图13示出了具有多个球囊的导管的另一局部剖视图。在该实施方案940中,球囊942位于球囊943内。两个球囊均可与充气腔连通,并且可根据操作者的需要同时或单独充气。球囊942为低柔度球囊,其直径适于使导管末端部分地自行集中在脉管中。更高柔度的更软外球囊943在凝块抽吸或收回之前提供无创伤脉管阻塞,从而提供流动阻滞。该脉管阻塞可在两个球囊中具有相同压力的情况下发生,或者可根据程序的阶段对其中一个球囊施加增加的压力。
图14示出了凝块收回导管960的局部剖视图,该凝块收回导管具有安装在远侧末端处的可膨胀球囊963。图8和图9示出了将球囊附接在导管的远侧末端处的益处,这样使得远侧末端和球囊之间不存在“死空间”,并且随后当凝块被收回到导管中时降低了凝块剪切的风险。图14示出了可如何通过倒转球囊的颈部962来将球囊963附接到导管964,以在末端961处实现最佳定位。一种组装方法是将球囊962的颈部粘结或焊接到导管961的末端,然后将球囊倒转并将球囊的近侧颈部965接合到导管964。以该方式将球囊接合到导管不仅减少了凝块剪切,还允许导管961的无创伤末端在凝块收回过程中张开并充当凝块的引入端。
图15示出了与图14中所示类似的球囊导管构造。然而,在该实施方案980中,球囊983的远侧颈部982附接到导管末端981的内表面。在该设计中,远侧颈部982的粘结可在近侧颈部粘结之前或之后通过在导管内倒转球囊颈部来完成。
图16a为本发明的远侧端部1000的局部剖视图,示出了安装在导管轴1004上的可膨胀构件1001的示意图。可膨胀元件1001在1005处和导管的远侧末端1003处朝近侧接合到导管。可膨胀元件1002的颈部被示出为在与末端1003的接合处是倒转的,使得元件1001完全膨胀到末端1003,降低了如本专利中其它地方所讨论的凝块剪切的风险。此外,随着元件1001膨胀,其将拉力施加到导管末端1003。在该实施方案中,远侧末端段1006具有比导管段1004更低的抗弯刚度,使得末端1003可在拉力下张开并膨胀成漏斗形状,以有利于提高凝块收回性能。
图16b示出了与图16a中示意图中所示装置类似的远侧导管构造的剖面图。该实施方案中的可膨胀元件为球囊1020,该球囊在球囊1022的近侧端部处接合到导管1026。将球囊的远侧端部倒转并焊接到导管材料1027以形成远侧末端1023。导管1026被构造成使得材料1027在导管增强编织物1025的远侧突出并且位于充气腔1021下方。充气腔1021提供用于将流体引入球囊1020中以进行膨胀的通道。当球囊膨胀时,球囊1020中的拉力将末端1023(编织物1025的远侧)拉成漏斗形状,以提高凝块移除的效力。将远侧不透射线标记物1024结合到导管构造中,以指示荧光镜透视下远侧末端在脉管系统中的位置。不透射线标记物1024形成为能易于膨胀的形状,从而不会限制导管末端1023的膨胀。
图16c为本发明的另一导管的远侧端部的局部剖视。它以膨胀构造示出,并且在该情况下,球囊颈部1040粘结到导管材料1041,该导管材料突出于衬里1042和编织物上方。不透射线标记物1043示出为膨胀的,以有利于远侧导管末端形成漏斗或引入端形状1026。
图16d示出了未膨胀构造中具有末端1063的导管1060的远侧视图。该图像示出了如何在皱褶1062中形成远侧末端材料,以在球囊膨胀时有利于膨胀成漏斗形状。不透射线标记物1061围绕皱褶1062成形,但仍具有可膨胀能力。
图16e至图16g分别示出了用于结合到凝块捕获导管中的可供选择的不透射线的远侧标记物1080的等轴视图、侧视图和端视图。该标记物由高度不透射线的材料形成,诸如金、铂或钨,呈管状形状,具有开槽切口1081,以允许标记物膨胀。另选地,可使用涂覆有金的镍钛诺标记物,使得其可在球囊放气后恢复其初始形状。该形状的标记物的益处在于,它可防止导管末端朝向导管的中心线向内塌缩,从而在球囊膨胀时减小抽吸腔。
图16h和图16i分别示出了类似的可膨胀不透射线标记物1090的侧视图和端视图,该标记物具有增加的槽宽1091以增进与导管末端材料的结合。该标记物也是可膨胀的,同时限制了在外部压力下直径的减小。使用不透射线标记物或其它增强物以防止球囊充气时内径减小,允许使用更柔软的导管末端材料。
图17a为本发明的另一实施方案的横剖面视图。该图示出了在可膨胀元件1107膨胀之前处于引入构造中的凝块收回导管1100的远侧端部。导管被构造成具有安装在导管的主体段1109上的可膨胀元件或球囊1107。球囊分别在1105和1104处在近侧端部和远侧端部粘结,并且与充气腔(未示出)连通以有利于膨胀。材料条带1108安装在球囊上并且朝近侧1106接合到导管主体1109。材料条带1108的远侧端部粘结到无创伤远侧导管末端1102。在该构造中,在接合到导管末端1102之前,条带1108的远侧端部被倒转1103。多个材料条带1108径向地围绕球囊1107定位。
图17b示出了其展开或膨胀构造中的装置1100。流体已注入球囊1134中以使其膨胀并阻塞脉管,造成流动阻滞以提高凝块收回的效力。在该实施方案中,材料条带1133由具有薄壁的低弹性柔度聚合物诸如PET制成。当球囊1134膨胀时,这些材料条带1133处于拉力下,并且该拉力使导管1132的无创伤末端变形,从而使远侧边缘膨胀并形成漏斗形状1132。通过在接合到导管末端之前倒转条带1133的端部1131,它确保施加到末端的拉力在远侧端部处,形成更大直径的漏斗形状。
图17c为与图17b中所示装置类似的装置的等轴型视图。在该情况下,材料条带1163径向地围绕球囊1160定位,并且在1164处接合到球囊近侧的导管。条带1163的远侧端部被倒转1161并且粘结到导管末端1162。球囊1160的膨胀拉出材料条带1163,使拉力施加到导管末端1162,从而形成漏斗形状。
图18a为本发明另一实施方案的剖面示意图。导管的远侧端部1200由安装在导管轴1203上的远侧球囊1201构成。如前所述,当球囊1201膨胀时,其通过阻塞流动在脉管中提供流动阻滞能力。此外,球囊膨胀将拉力施加到导管末端1202,使其形成漏斗形状,从而改善凝块的引入端,减少凝块剪切并提高用支架收回器进行抽吸和凝块收回的效力。
图18b为根据图18a的剖视图A-A,示出了复合球囊构造,该复合球囊构造由散布有弹性可膨胀材料1221的段的半刚性肋1222组成。当流体通过充气腔(未示出)被引入球囊中时,压力增加并且软段1221的直径膨胀,在脉管中造成流动阻塞。肋1222可具有与可膨胀段1221不同的硬度,会更有效地将拉力传递到远侧末端并且增强球囊使末端膨胀以形成漏斗形状的能力。肋1222可与球囊材料共挤出,或者可通过将线材或其它材料集成到球囊挤出物中而形成。肋可平行于导管的轴线延伸,或者可形成为螺旋构造以提升球囊的流动阻滞能力。
图18c示出了非膨胀构造中的剖面A-A,其中肋1242和可膨胀段1241在将导管引入目标位置期间同心。
图18d示出了非膨胀构造中的另选的球囊剖视图。在该实施方案中,球囊1260由围绕圆周具有不同壁厚的单个型材挤出物形成。具有减小壁厚的区域1261在压力下膨胀,从而在脉管中形成流动阻滞,而具有增大壁厚的段1262充当向无创伤导管末端施加拉力的肋,从而使其膨胀。
图19a示出了本发明的凝块收回导管1300的一个实施方案的柄部或近侧区域的程式化视图,其中可对球囊1301进行充气和放气而无需提前准备或冲洗充气区域。这可通过密封系统实现,其中充气腔和充气区域排空所有空气,然后填充无菌不透射线溶液。因此操作者仅需转动螺纹旋钮或致动器1307,即可将球囊1301充气至所需直径。导管1300包括伸长轴1308,该伸长轴在其远侧端部处具有可充气球囊1301并且在其近侧端部处具有近侧毂组件1302。轴和球囊可按照本文先前公开的那些中的任何一种来构造。近侧毂组件包括充气控制器1306、侧口1303(任选)、制备口1311和近侧连接器1305。近侧连接器1305可为旋转止血阀或者可仅为鲁尔或连接器,阀或其它鲁尔、连接器或配件可附接到其上,并且/或者其它导管或装置可通过其被推进或缩回。容纳于充气控制器1306内的腔室1314内的无菌不透射线溶液可包括造影剂诸如碘溶液。
图19b示出了通过图19a的导管1300的近侧毂组件1302的一部分所取的剖视图。螺纹旋钮1307的顺时针旋转使得旋钮1307的端部1315压缩波纹状构件1310。这继而减小了波纹状构件1310内的腔室1314的体积,迫使流体(可为无菌造影剂)流出腔室并进入充气腔1313,该充气腔从充气控制器穿过伸长轴1308到达远侧可充气球囊1301。这继而使得球囊充气,并且可通过控制旋钮拧入充气控制器中的深度来控制充气程度。可使用透明的充气控制器主体1306,通过该充气控制器主体可看见暗的/不透明的旋钮,从而允许操作者将旋钮1315的端部与控制器主体上的适当标记对准。旋钮1307的逆时针旋转允许波纹状腔室1310膨胀,并且可以用螺旋弹簧1309来辅助该膨胀。该膨胀从球囊通过充气口拉回流体,使球囊放气。
制备口1311和密封帽1312用于在使用之前排空、填充并密封该装置。在优选的实施方案中,这些步骤由制造商执行,并且将该装置提供给客户以供使用。
在另选的实施方案中,这些排空、预备和密封步骤可在第一操作者使用装置之前由第二操作者(诸如导管实验室护士或技术人员或同事)完成。
图20a示出了本发明的不同实施方案的远侧端部,其中球囊1402安装在导管轴1401上。球囊1402示出为膨胀构造,并且远侧末端1403形成非均匀形状。末端1403在收回期间仍为凝块提供引入端,从而提高效力并减少凝块剪切。远侧末端的形状可为对称的,并且与导管轴的弯曲元件对准。
图20b示出了另选的实施方案,其中无创远侧末端1423在引入期间形成偏心形状,并且还可膨胀以形成用于凝块的偏心引入端或漏斗。
图20c示出了如何将与图20b的导管类似的导管定位在神经脉管系统1441中,使得球囊1440形成流动阻滞,并且偏心末端1443为凝块收回提供引入端。在此类系统的一个实施方案中,导管轴1442在无约束状态下偏置成具有弯曲形状,以有助于将偏心球囊末端适当地定向到脉管系统。在一个实施方案中,该弯曲部包括紧邻球囊1440近侧的弯曲部,如所示。在另一实施方案中,弯曲部包括更近侧的弯曲部,其被设计成定位在患者的主动脉弓内。在又一实施方案中,导管包括两个此类弯曲部。在又一实施方案中,导管包括多个弯曲部。在又一实施方案中,导管包括可操纵元件,通过该可操纵元件,可在导管通过脉管系统被推进至目标位点期间或之后选择性地将弯曲部施加到导管上。
根据以上描述将显而易见的是,虽然已经图示并描述了本发明的具体实施方案,但是可在不脱离本发明的实质和范围的情况下进行各种修改。例如,虽然本文描述的实施方案涉及具体特征结构,但是本发明包括具有不同特征结构的组合的实施方案。本发明还包括不包括所描述的所有特定特征结构的实施方案。
本发明不限于上文描述的实施方案,这些实施方案的构造和细节可变化。
Claims (32)
1.一种凝块捕获导管,所述凝块捕获导管包括伸长管轴,所述伸长管轴具有近侧端部、远侧端部和在所述远侧端部处的可充气式可膨胀构件,所述可膨胀构件能够从塌缩输送构造充气成膨胀构造,其中在所述膨胀构造中,所述可膨胀构件延伸到至少所述伸长管轴的最远侧末端,并且在所述伸长管轴的最远侧末端处从所述伸长管轴径向向外延伸,以限定管头,其中所述可膨胀构件包括球囊;
其中,所述球囊的膨胀对所述伸长管轴的最远侧末端施加张力,从而使所述伸长管轴的远侧部分形成漏斗形状;
其中,所述伸长管轴的远侧部分包括不同刚度的远侧段和近侧段且在它们之间限定铰链,所述远侧段具有比所述近侧段更低的抗弯刚度,并且所述铰链被所述球囊包围。
2.根据权利要求1所述的凝块捕获导管,其中在所述膨胀构造中,所述可膨胀构件朝远侧延伸超过所述伸长管轴的最远侧末端。
3.根据权利要求1所述的凝块捕获导管,其中在所述膨胀构造中,所述球囊为具有扩大的远侧进入管头和较窄的近侧端部的漏斗形状。
4.根据权利要求1所述的凝块捕获导管,其中所述球囊与所述伸长管轴的远侧末端成一体。
5.根据权利要求4所述的凝块捕获导管,其中所述可膨胀构件由聚合物管形成,所述聚合物管被倒转,使得所述球囊和所述伸长管轴之间的远侧结合部位于所述球囊内。
6.根据权利要求1至5中任一项所述的凝块捕获导管,其中所述球囊包括彼此具有不同性质的区域。
7.根据权利要求6所述的凝块捕获导管,其中所述球囊包括近侧区域、远侧区域以及在所述近侧区域和所述远侧区域之间的中间区域,并且其中在所述膨胀构造中,所述远侧区域比所述近侧区域膨胀至更大程度。
8.根据权利要求7所述的凝块捕获导管,其中至少一个区域具有与至少一个其它区域不同的壁厚。
9.根据权利要求8所述的凝块捕获导管,其中所述近侧区域和所述远侧区域的壁厚大于所述中间区域的壁厚。
10.根据权利要求8所述的凝块捕获导管,其中所述近侧区域的壁厚大于所述中间区域和所述远侧区域的壁厚。
11.根据权利要求1至5中任一项所述的凝块捕获导管,其中所述可膨胀构件在所述塌缩构造中延伸超出所述伸长管轴的远侧末端。
12.根据权利要求11所述的凝块捕获导管,其中所述可膨胀构件延伸超出所述伸长管轴的远侧末端达0.5mm至3.5mm的距离。
13.根据权利要求1至5中任一项所述的凝块捕获导管,其中所述伸长管轴包括主内腔和用于使所述可膨胀构件充气的充气腔。
14.根据权利要求13所述的凝块捕获导管,其中所述充气腔在所述伸长管轴的壁内延伸。
15.根据权利要求13所述的凝块捕获导管,其中所述充气腔和所述导管腔是偏心的。
16.根据权利要求13所述的凝块捕获导管,其中所述充气腔和所述导管腔是同心的。
17.根据权利要求1至5中任一项所述的凝块捕获导管,其中所述可充气式可膨胀构件包括无定形弹性体聚合物。
18.根据权利要求17所述的凝块捕获导管,其中所述弹性体聚合物为热塑性聚氨酯弹性体。
19.根据权利要求1至5中任一项所述的凝块捕获导管,其中所述导管的伸长管轴的一部分包括所述可充气式可膨胀构件。
20.根据权利要求18所述的凝块捕获导管,其中所述伸长管轴的远侧区域包括无定形弹性体聚合物。
21.根据权利要求20所述的凝块捕获导管,其中所述导管的远侧区域的无定形弹性体聚合物为热塑性聚氨酯弹性体。
22.根据权利要求18所述的凝块捕获导管,其中所述伸长管轴的远侧部分包括第一无定形弹性体聚合物,并且所述可充气式可膨胀构件包括不同于所述第一无定形弹性体聚合物的第二无定形弹性体聚合物。
23.根据权利要求1至5中任一项所述的凝块捕获导管,其中在所述膨胀构造中,所述可膨胀构件的最远侧部分的有效直径比所述伸长管轴的远侧端部处的内腔的直径大至少20%。
24.根据权利要求23所述的凝块捕获导管,其中所述有效直径比所述伸长管轴的远侧端部处的内腔的直径大至少30%、至少40%、至少50%、至少60%、至少70%、至少80%、至少90%或至少100%。
25.根据权利要求1至5中任一项所述的凝块捕获导管,其中所述可膨胀构件的远侧末端区域以张角从所述伸长管轴的腔朝外张开。
26.根据权利要求25所述的凝块捕获导管,其中所述张角为10度至60度或15度至45度。
27.根据权利要求25所述的凝块捕获导管,其中所述可膨胀构件包括特征部以有助于所述远侧末端区域的张开。
28.根据权利要求1至5中任一项所述的凝块捕获导管,其中所述可充气构件被倒转并在近侧接合区域处接合到所述伸长管轴,其中所述伸长管轴包括多个层,所述多个层包括外套管、中间层、内衬和增强编织物或线圈。
29.根据权利要求28所述的凝块捕获导管,其中所述可充气构件的近侧端部在近侧接合区域处接合到所述伸长管轴,并且所述可充气构件的另一端被倒转并在结合部处接合到所述中间层,使得形成所述可膨胀构件的大致管状的聚合物构件的中间段被定位在所述导管的远侧端部处,并且位于所述结合部和所述中间段之间的管状聚合物构件的部分接合到所述伸长管轴的远侧段。
30.根据权利要求27所述的凝块捕获导管,其中所述特征部包括起伏部和/或弯折部。
31.一种套件,包括根据权利要求1至30中任一项所述的凝块捕获导管、凝块接合装置以及用于所述凝块接合装置的微导管。
32.根据权利要求31所述的套件,其中所述凝块接合装置为支架收回器装置。
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KR20190043144A (ko) | 2019-04-25 |
US20190167287A1 (en) | 2019-06-06 |
CO2019002233A2 (es) | 2019-07-31 |
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