CN103442653B - 两阶段展开动脉瘤栓塞装置 - Google Patents
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Abstract
本发明公开了栓塞植入物、输送系统以及制造与输送方法。本植入物分两个阶段被展开。如果在第一阶段观察到形成合适的尺寸,则本植入物被展开到第二阶段,然后脱离。如果在第一阶段没有形成合适的尺寸,则植入物被设计为退出并用尺寸更合适的植入物进行替换,或者选择其他治疗方案。有些植入物结构即使在第二阶段展开后也能退出。
Description
技术领域
本申请要求2010年2月11日提交的61/441845号美国专利申请的优先权。61/441845号申请的全部内容及其引用的参考文献都纳入本申请作为参考。
背景技术
许多公司已经研制用于治疗动脉瘤的球型栓塞装置。其中的很多(包括共有专利申请中披露的NfocusLUNA装置和其他实施例)都被设计为当植入物在输送导管的外侧完全展开时其尺寸贴合指定的动脉瘤。对于SequentMedical,Inc.公司公开和生产的编织物球(thebraid-ball)植入物来说也是这样。
至少对于LUNA装置而言,如果展开后可视化的尺寸(在放射性X射线下,也就是“医疗成像”)是医生来说可接受的,那么该植入物被脱离。如果不可接受,则取回该装置并换成更合适的尺寸。还没有被设计用于动脉瘤内治疗的装置的例子是在所述植入物最多仅展开到预选点或识别点的情况下通过医疗成像完成最终尺寸的确认。事实上,栓塞线圈常常在动脉瘤内被部分地展开并被可视化以在继续推进线圈和实施释放之前确认线圈的尺寸和/或结构是否可接受。但是,线圈没有被展开到如标记在输送系统上用于尺寸检查的指定位置。
发明内容
总体上描述了中断血液流动及形成血栓的用于动脉瘤或其他栓塞的编织物球。更具体地,本发明的变型涉及可以在单层编织物球植入物或双层“LUNA”型(即,折叠/平坦)植入物构造中使用的目标套区域构造。
在使用中,目标植入物的球体在动脉瘤中展开,且通过将导管标记物与装置近端对准,可视化所述近端的估计最终位置。所述植入物端部可包括带,或者作为构成所述植入物的编织物的套(比如通过焊接)。还公开了下面所描述的其他选项。
不管怎样,如果第一阶段/球体“合适”,那么相邻的收缩套区域完全展开(即第二阶段被展开),然后植入物从其推进器释放。导管轴标记物的位置和植入物的(第一)尺寸确定阶段的形状可以从所示和所述的多个选项以及其他选项中选择。
套区域的形状优选地被配置为在导管离开时提供自我致动的作用力。一种有利的配置是大致上球形。另一种预期的形状由围绕共同底部交汇的两个锥体限定。当插入物在截面上更靠近曲线(心形)时,被展开的套能在植入物内提供额外的血流饱和区。
在任何情况下,所述插入物被设置成使得即使在所述植入物被压缩以贴合高长径比的动脉瘤时插入物也能回缩。如所示那样,所述植入物在模拟动脉瘤的具有大约2:1穹宽比(dome-to-widthratio)的囊中是可操作的。基于植入物的结构,更高的比值也是可能的。
说明所述行为的示范实施例采用了小球形插入物区域。对于总体外径至少在6-7mm之间的植入物而言,所述插入物区域被限定在直径大约3mm的球形件上。因此,嵌套的插入物区域即使在被部分压缩的外球体中也能完全膨胀。当所述插入物区域采用双锥形状时,在中间折痕(medialcrease)处可得的额外储能进一步辅助驱动插入物形状的恢复。而且,所述锥形渐缩体能提供更大的间隙,用于在植入物的外体或球体被进一步压缩的情况下插入物模(insetform)的完全膨胀。
当被完全展开时,植入物的远端/终端以及任何相关的近侧套/带可以被定位在植入物的球体的外周处,或者以变化的水平定位在插入物处。当被用于“LUNA”折平结构中时,植入物的远侧标记物在内侧,系绳延伸到装置的近侧套。在一层的方案中(即一种在植入物的远端上具有一个层、而在近侧处根据插入物形状结构可以选择多个层的结构),远侧标记物由捕获编织物的不透射线材料(例如,Pt)带提供。对于任何一种装置的近侧而言,该装置可以包括捕获编织物的不透射线带。如在美国专利申请2011/0319926(Becking等人)中所描述那样,另一种选择是在所述编织物被胶合以形成复合套构造后去除所述带。
在另一种变型中,在限定所述植入物的编织物的近端处没有所述套或带。取而代之的是,一定长度的编织物(大约1-2mm长)被用作输送系统界面。这种编织物的“尾部”或套管当限定在导管中时能稳固地抓住/锁住互补的输送系统表面。在这种系统中,所述输送系统表面有利地由具有相似线尺寸和结构的编织物覆盖或构成,从而促进互锁。在植入物没有导管时,限定植入物尾部的(之前)受限编织物套管打开,从而允许内侧输送系统推进器构件被拉出。
分两个热固化阶段详细描述LUNA-型隐藏套式植入物的形成方法。阶段1用柱形插入物生产双层“折平”植入物预成型件。阶段2将上述插入物的形状改变为球形体积。在所述的第二形成和热固化程序中,可以采用近侧缝合线来限定与在阶段1中在远侧所形成的折平区域相同的第二折平区域。第二热固化周期也可以被用于改变外球体的形状。例如,在保持“折平”远侧弯曲部的同时,所述球体的总体形状可以从大致圆柱形被压缩为更短粗或平坦的“M&M”形(例如椭圆体)。被这样定形后,更大的径向力可用于动脉瘤贴合,和/或可获得更大范围的治疗部位。在美国专利申请No.12/465,475与PCT/US2009/041313中以及美国专利申请No.12/942,209与PCT/US2010/56051中公开能被用于本发明的更多的热固化方法和输送系统,它们的全部内容都纳入参考资料。
也可应用其他制造技术。例如,预期有一种有选择地热处理的方法,其中被定形的部分植入物预成型件被固化在铁磁材料(例如磁性304不锈钢合金)上,然后通过利用射频(RF)场的电感被加热。这种方法严格地对接触感应加热元件的区域进行热处理。为了确保其他材料不过多地受到加热影响,可以在有冷却剂(比如氮气或氩气或其他一些介质)流动的情况下实施该行为。在任何情况下,这种方案都可以被有利地用于前面所述的“阶段2”操作中,以重新定形所述插入物区域,同时不会对植入物预成型件的其余部分施加第二热处理。
目标植入物的本体可以由在人类体温下具有超弹性的镍钛合金构成。有利地,所述线的尺寸在0.0008到0.0013英寸的范围内,但是可以更大或更小。可以在热处理前/后采用AYA方案进行蚀刻或通过包括NDC,Inc.公司在内的服务提供商所采用的方法进行蚀刻。可以采用二元镍钛诺合金,或者所述合金可以包括金、铂、钨、铱、钯、及它们的合金、或者其他密集型元素以提高不透射线性。另一种提高不透射线性的方法预期使用多根与镍钛诺编织时相互混合的线或条带。或者,可以采用铂内核的镍钛诺拉制填充管(DrawnFilledTube,DFT)或其他手段。
所述编织物基体随着其密度的增加在促进血栓形成以栓塞动脉瘤方面特别有效。对于给定的导管截面轮廓而言,某个最大编织物结构是可能的。例如,如下文中进一步描述的“折平”植入物可以由72×0.001″的编织物结构构成(原始提供或对其蚀刻而成)或由96×0.0009″的编织物结构(同上)构成,该植入物旨在通过市面上可购买到的3Fr/0.027英寸导管(比如REBAR或MARKSMAN)到达神经脉管系统。在单层植入物构造中,144头编织物结构是可行的,其具有类似于线尺寸的直径范围在大约0.008到大约0.0011英寸内的截面轮廓。但是要注意到,更多头数的编织物(例如192或288)以及其他编织物头组合/结构也能被用于本发明中。同样地,可以将所述编织植入物构造为锯齿形以兼容0.021英寸导管。这些可以有利地采用两层48×0.001″的编织物或以更细线/丝的更多“头”数组合或单层72或96头编织物选择等等。
在任何情况下,本发明包括所述装置、包含该装置的套件、使用方法和制造方法。更详细的描述在下面结合附图给出。.
附图说明
本文中的附图并不按比例绘制,为了清楚的目的某些部件和特征被放大。根据所示实施例预期出本发明的多种变型。所以,图中所示的本发明的方案和元素并不意味着限制本发明的保护范围。
图1示出了在侧壁动脉瘤模型上展开的植入物的一种变型;
图2A和2B以及图3A和3B分别示意性地示出了在植入物展开的不同的第一和第二阶段与协同导管系统配合使用的植入物;
图4A-4D示出了在图2A-3B所示的展开阶段中通过透明导管被可视化的图1的植入物结构;
图5A-5F示出了插入物结构的变型;
图6A-6C示出了植入物的展开,其中无套输送系统界面采用另一种插入物结构;
图7A-7D示出了植入物制造的阶段;以及
图8是示出了多种植入物生产选项的流程图。
具体实施方式
在下面描述本发明方案的多个示范实施例。以非限制性的方式来参考这些示例。提供这些示例是为了展示本发明的更为广泛的可应用方案。在不脱离发明真实精神和范围的前提下,可以对所描述的主题进行多种变化,以及可以替换为等同物。
动脉瘤栓塞系统
本文所述的实施例被特别地设计,从而当植入物在动脉瘤内展开到指定阶段时,该阶段的尺寸代表了植入物在利用输送系统最终展开之后的最终尺寸和结构。与这种系统结合能获得若干优点。优点之一是能最小化输送轮廓和/或最小化独特的植入物/输送系统相互作用的复杂性。另一个优点是为指定的输送轮廓提供更大的植入物尺寸。其他一组优点包括容易重新捕获膨胀后的植入物,以及相关的手术和患者安全性优点。总之,本发明的各方案(单独和/或彼此组合)提供一种用于治疗神经脉管动脉瘤或者用于治疗其他脉管缺陷、囊式(pockettype)缺陷或管腔缺陷的有用的新系统。
图1示出了根据本方法被输送的植入物10,其在侧壁动脉瘤模型2中展开。所述模型包括载瘤血管4和被植入物10填充的动脉瘤基底6。所述植入物与推进器20相联着(优选地通过可脱离的联接,而不是简单的靠接)被输送。所述植入物包括外球体12和大致球形的插入物区域14。因此,在血液流动的方向(如箭头所示)上提供一种密集而复合的结构,从而有助于通过血流的中断促进血栓形成。在植入物的近侧区域16和远侧区域18处可选地设置标记物。
图2A和2B以及图3A和3B示意性地示出了与协同导管系统配合使用的植入物。图2A和2B示出了一种分阶段展开的可选方案;图3A和3B示出了另外一种。所有这些附图示出了一种总体的远侧植入物构造30,其中示意性地画出远侧标记物32。在每幅视图中,所述植入物包含作为与(可选脱离的)推进器40的界面区域的近侧套/标记物带34。所述套和推进器可以通过前面所提及的专利申请中所描述的机械脱离界面、电解可分开接头、可熔聚合物细丝等等相连。在任何情况下,所述推进器被示出在微导管50的端部内。所述微导管包括远侧标记物52和更近侧的参照标记物54。
在图2A中,参照标记物被设置在某个位置处,使得当植入物近侧套/标记物34与参照标记物对准时,植入物的自由/膨胀部分展开成“泪滴形”,所述“泪滴形”的高度与图2B和3B所示的最终展开的植入物形状的高度几乎相同。同样地,图3A中以54′示出的导管参照标记物被定位成使得当套34与导管参照标记物对准后,形成一种带有平坦部36的“蘑菇”形。另外,这种中间植入物主体形状的尺寸被类似地确定为最终输送的植入物结构。
因此,在任何一个中间输送阶段(即,在由图2A,3A所配置的系统和相关系统中),通过可视化植入物中或植入物上的所述远侧标记物32以及导管的远侧标记物52的位置,医生能确定所述植入物针对待治疗的动脉瘤是否选择了正确的尺寸。如果植入物处于第一/中间输送阶段时,导管的远侧标记物被定位在动脉瘤的颈部处,那么医生(在过程当中)获得如下信息:即在植入物展开完成后植入物的近侧表面将会按照所需那样同样地被定位。因此,本发明的一个方案涉及到一种带有标记物系统的导管和一种植入物(或植入物推进器,如下面所述那样),其包含在“最终”释放/被释放展开阶段之前协同用于第一展开“检查”阶段的不透射线标记物。
图4A-4D示出了在作为第二模型2′的玻璃容器内可视化的处于展开阶段中的植入物结构。示出所述植入物30处于限定在透明鞘50′(其用于模拟导管)内的多个位置处。在每幅图中能看到标记物元件34的近侧是线圈增强长度22(其用于模拟推进器)。图4A示出了在球形部分的第一展开阶段中的植入物,其中导管端部在A点。在图4B中,已经形成全尺寸的泪滴尺寸检查形状,其中导管端部在B点。在高度上几乎没有大变化或者没有大变化的情况下,形成蘑菇尺寸形状,其中导管端部在B′点。然而,从标记物34的移动能明显看出,推进器已经被推进。当推进器和标记物34前进到推进器脱离之前的最后/最终位置时,形成所述最终植入物形状,其中植入物的近侧表面的位置没有发生明显改变,如铅垂线箭头的对准所示。
特别地,之前所有附图示出插入物区域14的结构,其在图5A中以截面图的形式示出。同样,图5A示出了插入物区域14的尺寸适应不同压缩系数30,30′的相同植入物球或球体的方式。有利地如下面所描述那样形成图5A中相对(较)小的球形插入物结构。而且,它展示了如图所示的稳健的恢复和致动能力。但是,其他插入物形状或形式(form)提供了下面所描述的其他优点和选择。
例如,图5B示出了“心形”截面的插入物60。这种插入物沿着锥形近侧段62为球体压缩提供额外的间隙。另外,弯曲至远侧段的弯曲部64便于即使在所述延伸部66和套34完全离开输送导管的情况下也能重新捕获该装置。相反,图5C中所示的双锥形插入物70可以在较深的插入物“V”形结合部处与导管“锁”在一起。另外,双锥形可能是理想的,因为轮廓内尖锐的弯曲部或过渡部的数目增加能够帮助驱动可预测的形状恢复,以及提高在装置的近侧部分内对径向压力的抵抗。
图5D示出了第二种锥形插入物74。在这种变型中,两个锥体是相邻的,每个锥体具有各自的底部76,76′,而不是被结合为一个底部。另外,相比之前的变型,图5D示出了与先前变型相比能缩短或基本消除编织物的连接至套34的任何“尾部”或延伸段的方式。而且,上下锥体以不同的角度被固化,从而在78处封闭装置的近端。自然地,之前的插入物变型也能做类似的处理。
图5E示出了套34′的进/出口被倒置的方案。因此,重新捕获导管要求在编织物/套的结合部处形成180度的弯曲部。在导管内遵循相同的方式进行展开。该特征可以限制导管尺寸减小。但是,通过使用与粗导线相比以更小半径弯曲的较细导线(例如0.0008英寸直径或更小)能适应该特征。
另外,插入物延伸部82的长度和位置可以改变。例如,可期望的是延长插入物延伸部,使套标记物34′的位置大致上处于未被压缩的植入物30的中心,如虚线所示。当计划用多个被允许完全膨胀的相同植入物来填充空腔(例如在针对巨型动脉瘤的多球治疗方案中),而不是以形状贴合的方式将单个植入物填入动脉瘤时,所述这种方案是理想的。在这种情况下,所述套能作为一种被居中定位的单个标记物。
接下来,图5E示出了不具有套和/或标记物布置的插入物90。取而代之的,所述插入物被配置为特别与图6A-6C中所述的输送系统配合使用。所述插入物的形状被设置为当未被导管压缩时在球体92处是开放的,而当该形状被压缩在输送导管内时在弯曲部94处为输送系统的固定提供额外的压缩力(通过增大的线性压力)。
关于图6A-6C,这些附图示出了具有缸形或瓶形插入物100的植入物30,在图6B和6C中被示出为展开/张开。这种插入物提供有利的近侧间隙,其中平坦顶部102降低了插入物的高度,远侧折痕104在压缩后储存能量以在导管释放后驱动形状恢复。
更通常地,图6A示出的植入物30中,球体12在输送导管50外侧,而植入物尾部106(在其转变为插入物形状100之前)仍然位于输送导管内。所述尾部的界面段108包围推进器122的具有纹理(通过匹配编织物形成)的保持段120。
推进器的全长可以包含由聚酰亚胺包覆/共同挤压的金属编织物,且远侧段由编织物消融形成。该构造的部件和消融技术可从MicroLumen,Inc.公司获得。通过进一步有选择地消融和/或在推进器结构的管腔内包含渐缩的地线(浮接或粘接),能将渐缩的电线设计到轴内。
输送微导管包括远侧柔软末端56和远侧标记物52。导管上的近侧参照标记物54被示出位于推进器122上的一对参照标记物110之间。只要所述导管将植入物界面段保持为压缩到推进器保持段,就能够取出所述植入物。
但是,在如图6B中所示完全展开后,植入物和推进器之间的互锁界面就消失了。此时,推进器122可以如图6C中所示那样退出,并且导管也退出。在植入物被定位后,当推进器退出时导管的远端仍然标记植入物的近侧位置,且仅具有一较小间隙。
同样值得注意的是插入物被定形为便于植入物释放的方式。如图6C中的虚线特征102′和108′所示,所述插入物可以被定形为在离开输送微导管后具体地与推进器保持段脱离。
植入物制造
如前面所述,目标植入物的构造可以用于单层编织物球植入物或双层LUNA型(折叠/平坦)方案中。图7A-7D示出了后者的制造方案。通过参考12/465,475和12/942,209以及PCT/US2009/041313和PCT/US2010/56051专利申请能理解更多细节,以上文献的全部内容纳入参考资料。
如图7A所示,“阶段1”或“中间”状态的植入物预成型件200联合内部热固化工艺元件或模210以及在参考文献中所描述的其他元件一起被定形和热固化,且加入用套管212形成的长柱形插入物202。在编织物层230,232与模元件210,212之间紧密配合的情况下,在图示的转角224处形成小半径弯曲部。
当如图7B所示没有模元件的情况下,能更清楚地看出预成型件202包括大致球形的部分204以及插入物202和延伸或尾部区域206。插入物的深度“D”被调整以便于接收如图7C所示的次级内模214。在系物216保持其就位的情况下,球体204的区域(图7C所示的反转段204′)能被颠倒,或被“拍打”成图7D所示的形状。
在心轴218相对于模214固定就位(例如通过金属线220)的情况下,肩部222被用于压缩装置中的近侧折叠部234,并且平板或平坦部224能被用于在第二热固化步骤中将球体抵靠所述平板元件224压缩成被改变的形状(在这种情况下其截面更“短粗”或是椭圆形),从而限定“最终”形状预成型件200′的“阶段2”。
所述方法流程示出为图8流程图的左侧路径。特别地,在步骤300中将构成所述植入物的天然编织物(预先热固化或未热固化)形成在心轴/模件上和心轴/模件内之后,在步骤302中本体被热固化。离开第一组热固化装置以后,在步骤304中本体可选地被重新定形/重塑,之后是第二全面热固化程序306。最后,在步骤308中,执行其他工艺,比如可选地将标记物带设置为套、安装其他标记物特征、套焊接等等,然后装载到任何可选的输送系统推进器上,如通常那样包装和消毒。
作为一种替换流程,在第一热固化和第二定形之后,在步骤306′中只有所述插入物被热固化。这能够如上述那样,通过例如采用铁磁性材料和感应场将热量集中用于固化与元件214接触的编织物的形状来实现。
一般地,当所述编织物包括镍钛诺时,在500-550℃之间至多大约5分钟时间内完成任何热固化。所述加热后可以在水中进行淬火或进行其他处理。
不管怎样,还能预见的是,所述植入物的整个定形可以在一个更复杂的周期310中发生,其中植入物的球体和插入物部分均被同时形成在一组更复杂的嵌套模上。当所述植入物仅包括单层编织物、而不包括折平远侧段时,这种方案尤其可行。
变型
本方法可以包括医生的与植入物定位和释放相关的每一种行为。因此,暗示植入物装置定位和展开的方法也构成本发明的一部分。所述方法可以包括将植入物放置在脑动脉瘤内或者放置在计划栓塞的载瘤血管上,或其他应用。在某些方法中,可以考虑将植入物引入动脉瘤或载瘤血管的多种方案。更具体地,根据本发明的多种方法涉及例如输送系统操作以抵达治疗部位的方法。其他方法涉及制备用于输送植入物的系统的方法。
而且,能预期到,所描述的创造性变型的任何可选特征可以独立地提出和声明,或者结合本文所描述的任何一个或多个特征。提及到单数项,其包括存在相同的多个项的可能性。更具体地,如在本文中和后附权利要求中所使用的,单数形式“一”、“一个”、“所述”和“该”包含复数个指示物,除非另作特别说明。换句话说,在前面的描述和后面的权利要求中这些词语的使用允许目标项是“至少一个”。还需注意的是,权利要求可以被撰写为排除任何可选元素。因此,这种陈述意在作为与所宣称元素的叙述相关的排他术语“单独地”、“仅”和类似词语的使用、或“否定”限制的使用的在先基础。
在没有使用这些排他术语时,权利要求中的“包括”一词应当允许包含任意其他元素,不管是否在权利要求中列举了给定数量的元素,或者特征的增加被认为转变权利要求中所给出的元素的特性。除了本文中特别限定之外,本文所用的所有科技词汇在保持权利要求有效性的前提下都被赋予尽可能宽泛的常规含义。
本发明的保护范围不被限制为所提供的示例和/或说明书,而是仅由权利要求的保护范围确定。所有的引用文献的全文都被纳入参考资料。尽管为了清楚理解的目的详细描述了本发明,但是预期的是在权利要求的范围内能实施某些改动。
Claims (11)
1.一种动脉瘤治疗系统,系统包括:
具有远侧标记物和近侧参照标记物的导管;
植入物推进器;以及
包括球形部分和尾部部分的植入物,尾部部分能够以直线结构被接收在导管内以用于输送,并且当被输送时在球形部分内限定插入物,
其中,推进器和植入物的至少一个包括标记物,当所述标记物与近侧参照标记物对准时,所述标记物在第一阶段中至少定位植入物的球形部分,从而指示在第二阶段中植入物的最终展开高度。
2.根据权利要求1所述的系统,其中,球形部分在第一阶段中具有泪滴形状。
3.根据权利要求1所述的系统,其中,球形部分在第一阶段中具有蘑菇形状。
4.根据权利要求1所述的系统,其中,插入物被配置为在临床使用中能被重新捕获。
5.根据权利要求1所述的系统,其中,插入物被配置使得插入物在临床使用中不能被重新捕获。
6.根据权利要求5所述的系统,其中,插入物基本是球形的。
7.根据权利要求5所述的系统,其中,插入物具有相对的锥形形状。
8.根据权利要求5所述的系统,其中,插入物包括倒置的套。
9.根据权利要求5所述的系统,其中,插入物没有套。
10.根据权利要求9所述的系统,其中插入物能从受压缩的锥形形状膨胀。
11.根据权利要求10所述的系统,其中插入物能膨胀到球形部分中。
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CA2825774A1 (en) | 2012-08-16 |
EP2672900B1 (en) | 2017-11-01 |
CA2825774C (en) | 2017-02-28 |
US9393022B2 (en) | 2016-07-19 |
EP2672900A1 (en) | 2013-12-18 |
WO2012109606A1 (en) | 2012-08-16 |
JP5868432B2 (ja) | 2016-02-24 |
AU2012214240B2 (en) | 2015-03-12 |
JP2014512872A (ja) | 2014-05-29 |
CN103442653A (zh) | 2013-12-11 |
US20140172001A1 (en) | 2014-06-19 |
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