CN102940514B - 编织球栓塞装置及输送系统 - Google Patents

编织球栓塞装置及输送系统 Download PDF

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CN102940514B
CN102940514B CN201210458306.2A CN201210458306A CN102940514B CN 102940514 B CN102940514 B CN 102940514B CN 201210458306 A CN201210458306 A CN 201210458306A CN 102940514 B CN102940514 B CN 102940514B
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阿图罗·S·罗斯克塔
弗兰克·P·贝金
玛丽亚·G·阿沃伊特斯
西达尔特·洛加纳森
武驰
塞佩尔·法里亚比
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科维蒂恩有限合伙公司
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Abstract

公开了栓塞型植入物、输送系统及制造方法和输送方法。该装置可用于动脉瘤治疗和/或载瘤血管闭塞。植入物的设计提供了小外形压缩性以便于输送到神经血管系统中,同时保持了其它的必要特征、例如用于闭塞目的的密度和期望的径向强度特性。

Description

编织球栓塞装置及输送系统

[0001]本申请是申请日为2009年4月21的、题为"编织球栓塞装置及输送系统,,的发明专 利申请2〇〇98〇114155_5(国际申请号:PCT/US 2〇〇9/〇4l3l3)的分案申请。

技术领域

[0002]自血管闭塞弹簧圈的使用得到广泛开展的1 "0年代以来,频内动脉瘤的血管内治 疗的主流临床实践变化很小。当然,改进的导管和其它的辅助装置(例如,支架)有助于使弹 簧圈缠绕过程更安全和/或更高效。但是,实现充分且合适的动脉瘤弹簧圈填塞的技艺最好 由具有最熟练技能的医师完成。

背景技术

[0003]如可行,优选地是以覆盖式装置(例如,如本文受让人的美国专利申请第丨2/397, 123号)进行动脉瘤隔绝。另一些人尝试背离动脉瘤内弹簧圈填塞术而改弦更张,通过在载 瘤血管中放置动脉瘤外的阻流器/引流器而获得栓塞。这些紧密编织的装置和/或层层叠覆 的多重编织装置跨过动脉瘤颈放置在载瘤血管中,以用于改变血液动力学从而实现栓塞。 [000 4]这些WALLSTENT式装置最适于跨过侧壁动脉瘤放置。然而,据一些人估计,末梢动 脉瘤(例如,分叉部动脉瘤)占所有动脉瘤发生例的大约60%到80%。按最乐观的计算,只有大 约40%的颅内动脉瘤能够通过用上述支架式装置进行治疗。

[0005]已经构思出多种其它的装置以试图解决末梢动脉瘤问题。很多装置常常需要复杂 的和/或不切实际的放置。另一些又只是作为弹簧圈或液体栓塞剂的辅助。在这些后者的示 例中,过程可能变得更加复杂并且比标准的弹簧圈缠绕过程需要甚至更多的医师技巧。

[0006] 在Dieck等人的PCT/US 20〇7/0〇76232中提出了一种更简单的、然而有希望的解决 方案。描述了一种用于使得将血流从流向动脉瘤颈转向的编织式/网状圆锥形构件。装置的 基部设置在动脉瘤内,而引流器部分延伸到载瘤血管内以引导血液流向毗邻的侧分支并远 离动脉瘤。植入物可定位在动脉瘤内作为单独的装置或者由相连的支架式本体支承。

[0007] Mazzochi等人的美国专利6,168,622和6,506,204公开了另一种类型的编织式阻 流器,其至少部分地设置在动脉瘤内。球状部分适于配合到动脉瘤顶内并且通过颈覆盖翼 锚固在外侧。考虑到分叉部动脉瘤经常结合分支血管结构的方式,这种补丁 (patch)经常影 响和/或"唤起(flap)"不受控制地产生的在载瘤血管中形成潜在的病理血栓的重要问题。

[0008] 本发明的植入物解决了每一个上述装置的缺点。这样,主题植入物(以及它们相关 的输送系统)提供了推进血管畸形一一包括动脉瘤在内一一的血管内治疗的技术状态的可 能性。

发明内容

[0009] 本发明指向用于在血管内的位置闭塞血流的线编织球植入物。也描述了输送系统 和制备球的方法。对于治疗神经血管缺陷而言,这种球是有益的。一个用途是用在颅内动脉 瘤栓塞/闭塞手术中,而另一个是用在载瘤血管闭塞(PV0)或牺牲手术中。

[0010] 一般而言,本主题的血管植入物是利用生物稳定材料的组合的编织式装置,这些 生物稳定材料选自不锈钢、钴铬合金、镇钛诺、钛、钛合金、销和错合金、PET (或另一种缝合 材料)及医用级粘合剂。在编织物自身旨在影响血流、允许由球形成的体积内的血栓闭塞该 位置的应用中,装置的密度至关重要。因此通常需要高密度的编织物/网。即,可以采用具有 至少大约48端、通常设定成大约90度或更大、直径为大约4mm到大约8mm的编织物。在直径更 大(例如,大约6mm到12mm或更大)时,在球的形成过程中可采用更多的线端(例如,64、72、 96、128、144的公倍数)。也可采用更高的常用线数。可采用市售W2和288锭标准编织机中的 任意一个。此外,可使用三维编织技术(由3Tex,Inc •提供该服务)形成编织交叉结构,由该 编织交叉结构形成球。另外,可使用线直径、线数、编织角和每英寸交叉数的任意组合来制 作编织物,从而构造成适于特定脉管位置的血栓和血流闭塞装置。

[0011] 可采用一定范围内的线尺寸或者线尺寸的组合,该范围通常从大约0.0008英寸到 大约0.0015英寸,并且根据期望的输送外形可达到大约0.003英寸(其通常期望小于大约 0.050英寸--至少对于神经血管适应症(indication)来说--并且更一般地,对于周围 PV0适应症来说达到大约0.070英寸)。单个的编织管可使得所有的线具有相同的直径,或者 可使得一些线具有稍微粗的直径以增加编织层的强度。例如,96线管中一半的线(g卩,48端) 可以是直径例如为0.001",而另一半的线可以是直径例如为0.0015"。在该情况下,在制作 编织物时通常均匀地交织这两种尺寸的线。较粗的线在没有显著增加装置输送外形的情况 下为编织物提供了更大的强度,而更细的线在填充编织交叉结构密度的同时提供了一些强 度。

[0012] 线优选为在体温时具有超弹性的镍钛合金。金属可以是二元合金或者三元合金以 提供额外的射线不透性。可替代地,编织物中可包括不透射线的铂纤维,或者线可包括铂或 金芯镍钛诺DFT。另外,用于紧固编织线(在远端和近端中的任一端或两端处,并且适当时也 在帽部之间)的集线部、箍带或包绕器(优选为铀)可作为单独的不透射线特征。

[0013] 为了在热定形后改进植入物的线的耐腐蚀性和/或生物相容性,可在"AYA"氨基磺 酸溶液中腐蚀植入物,然后在硝酸溶液中钝化。可替代地或附加地,可在编织植入物交叉结 构时采用预腐蚀和/或抛光的线。将编织物定形成植入物的形状可以在烤炉/火炉、流化加 热炉或盐浴坩埚中进行,所有这些处理都落在本领域普通技术人员的知识范围内。

[0014] 具体地,在热定形后,可在线上涂覆用于促进期望的生物效果的制剂。例如,可在 线上涂覆促凝剂或者内皮化(endothe 1 izat ion)制剂,或者能够在目标位置促进期望的生 物过程的其它制剂。在涂层并不会导致最终装置的输送外形超出容许限制的前提下,编织 球也可在其外表面上部分或全部地覆有涂层(例如,以诸如聚氨酯之类进行涂覆)以提高球 的闭塞效果。水凝胶涂层也提供了一个吸引人的选择,例如如Won等人的美国专利6,905, 700中描述的一种能够夹带治疗性药剂的水凝胶基聚合物网。

[0015] 类似地,虽然球有利地包括镍钛诺编织物,但编织物也可替代地包括聚合物-- 特别是高强度的可生物降解的聚合物,例如MX-2(MAX-芘)、合成吸收性单丝(90/10乙交酯/ L-丙交酯)和/或G-2 (Glycoprene)、可热定形的(例如,在110摄氏度下1小时)合成吸收性单 丝(乙交酯(PGA)、e-己内酯(PCL)、三亚甲基碳酸酯(TMC)共聚物。

[0016] 将主题植入物输送到特定神经血管位置(例如,末梢颅内动脉瘤)经常需要它们是 可压缩的以便于穿过导管,该导管的尺寸确定成用于在脑部的狭窄弯曲的血管中前进。适 于该应用的标准神经血管导管具有0.021"和0.〇27"的内腔直径。特别是对于更高线数的球 0.〇27" ID(例如,Cordis公司Mass Transit型Boston Scientific公司Renegade HI-FLO型 (Cordis Mass Transit Boston Scientific Renegade HI-FL0))或更大的(例如,0.044" ID Concentric公司Merci型远端进入导管(ConcentricMerci Distal Access Catheter)) 来说,市售微导管是优选的。对于使用更高线数和/或更大线径以保证锚固的、适于解决PVO 适应症的装置来说,植入物可能需要5和/或6Fr的引导管以便于输送。

[0017] 在所述构型的任意一个中,装置可包括高密度的镍钛诺编织物,该编织物在其自 身上折叠/折回并且热定形以提供具有两个相邻层的开口本体,从而形成更密的交叉结构 以闭塞血流。可将折回(内翻或外翻)部分封闭以限定装置的远端端部,不透射线特征可定 位在该处。在植入物的相反侧,编织丝固定在集线部中,该集线部至少包括外箍带。

[0018] 集线部内的端口可接收可选的可分离推送器的部件。可替代地,可利用简单的推 送器通过导管放置植入物。集线部中的编织丝可以彼此焊接和/或焊接到箍带上。可替代 地,可利用生物相容性的粘合剂紧固编织物和集线部。

[0019] 在松弛状态下,植入物限定优选为球状的开口体。在输送导管内,它们压缩成大致 呈圆柱体。当放置在治疗位置时,它们展开以抵接周围的组织并且在临床相关的时间段内 闭塞流动。

[0020] 可分离推送器的使用考虑到放置装置(例如,在动脉瘤中)及配合检查。当放置在 动脉瘤中以在其颈部闭塞动脉瘤时,植入物装置大致呈现动脉瘤的形状,使近端集线部以 及紧邻的编织材料处于颈部的外侧。为了实现这种配合,提供了一定尺寸范围的植入物。它 们可以以0.5mm到1mm的直径增量增大。对于分叉部的动脉瘤治疗来说,如以上所引用的 Dieck等人的描述,可能还期望球(至少在其输送构型中)呈水滴形状以帮助分配器/转向器 类型的功能。

[0021] 然而,如果选择的植入物不能如期望的那样配合,则可以简单地将它缩回到输送 导管中。如果通过医学成像证实(用第一次植入物或者替代物)实现了期望的配合,则释放 该植入物。

[0022] 可使用电解可脱性⑶C式接头以保持植入物紧固到推送器上直到释放。关于合适 的电解分离系统的细节可以如Gug 1 i e lmi的美国专利5,122,136及其继续申请--所有这 些申请以参引的方式在此全文并入一一中所指导的那样理解并应用到现有系统中。另一个 电动分离方法采用可熔纤维或缝合线接合将植入物连接到输送推送器/引导件。在这种系 统中,聚合物芯可以构造有螺旋状缠绕的导电带,该导电带固定到芯上。在施加电压后,足 够的电流通过该带流动到连接它们的线桥。沿该桥一一可选地为镍铬线一一产生的热对系 到该桥上或者靠近该桥延伸的缝合线起作用以释放植入物。所并入的临时申请中描述了合 适的缝合线熔化分离系统的进一步的细节。

[0023] 然而,机械分离系统可能是更加优选的。本发明的一个方面涉及推送器,其中至少 一个构件提供了在植入物集线部端口处的/与植入物集线部端口的机械干涉,从而以可释 放的方式将植入物锁定到推送器上。在一种方法中,从该推送器的延伸部引出的、穿过该端 口的线或带产生这种干涉,直到它被缩回。在另一个示例中,通过端口接收有多个线/带。这 些线中的一根或多根(通常是两根或三根)延伸穿过推送器导管本体到达近端把手接合部。 通过该端口接收的最后的"锚固"线也可以延伸到把手。锚固线包括一头部,该头部的尺寸 确定成只有在其匕控制线清除后才能够离开集线部端口。头部优选地由激光或等离子体 加热/溶化而形成。把手提供了用户接合部,以首先移除控制线、然后再(可选地)拉出最后 的锚固线。

[0024]为了在不应该释放植入物时有助于将它收回,可在集线部与植入物主体之间设置 光滑的导入/喇机状收回外形。在另一种涉及双层植入物的方法中,没有设置这种外形。而 是,只有外编织层紧固在集线部内,而内层"浮动"。这样,只有外层必须相对于集线部校直 以便于将球收回到导官/鞘套中,而内层跟着一起(riding along)。

[0025]为了容许这种操作,编织物交叉结构必须保持稳定和锁联。因此,当可能时,优选 的是一个压一个(one-over-one)的编织样式。此外,应该在邻接集线部的位置--在该位 置由集线部紧固的编织物是最密的一一修剪编织物。通过这样构造,外编织层作为引导件 并且具有防止内层的松散端部刺透的密度。虽然由于降低了径向强度,浮动层式球植入物 通常只用于动脉瘤适应症,但是收回外形可用于旨在动脉瘤或PV0应用中的任何植入物上。 [00 26]除了收回特征外,当在血管中展开以用于载瘤血管闭塞时,主题植入物呈"香肠 (sausage)"状。为了这些目的,可能期望球的压缩后的长度相对于其直径尽可能小。为了该 目的,球的近端和/或远端端部可以变平或较平(使得球更像"油炸圈饼(donut)"状)。

[0027]装置相对于血管的偏大尺寸提供了足够的径向力以克服血液流动/压力而锚固在 其位置上。为了在用于PV0专用植入物(g卩,给定的展开长度)的血管中产生更大的锚固力, 球可形成为具有椭圆形横截面的形状。为了提供进一步改进的血管锚固,可在其形状中结 合圆筒形腰部。在一些情况下,所形成的边将在血管壁上集中应力以增强锚固。而且,整体 形状允许植入物在较宽的血管尺寸范围内工作。事实上,一个尺寸可适合较宽的血管直径 范围(例如,l〇mm的球适于3-5mm的血管,等)。

[0028] 在任一种类型的植入物(g卩,动脉瘤或PV0)中,有利的构造涉及在制造过程中折叠 或折回编织物以产生双层交叉结构。在编织物中形成中间折痕或折叠部,其用于限定植入 物的一个端部。

[0029] 折叠部可以预设在编织物中或者在夹紧编织物以定形时形成。在前一种情况下, 通过在将编织物限制在紧贴的管状模型中(例如,通过卷边机或至少部分地在海波管内)时 对编织物进行热定形而预设定弯曲。在后一种情况下,用缝合线在一个点系住编织物,将模 型插入到编织管的开口端,并且就模型进行拉伸或定位编织物,此时其折叠部分受压。当受 热定形时,烧掉缝合线,而压缩力将折叠部设定成半径尽可能小。

[0030] 折叠部本身证实在多个方面有用。在本发明的一个变型中,折叠部分为植入物提 供了防损伤端部。折叠部分可以留出开口,或者由缝合线、线(或其它材料)环打结封闭。如 果结本身不是不透射线的,则结还可保持标记箍带(系住、胶粘或卷曲缠上)。在设置这种 标记物的情况下,其可有利地在内部容积中靠近球的顶端/远端端部悬挂。

[0031] 无论何种情况,在压缩成输送外形时,植入物本体基本上在折叠部处枢转(而不是 弯曲),因此使得导管内/鞘套内的力最小化。这改进了装置的可追踪性和输送性、以及在期 望以另一种尺寸的装置进行治疗的情况下的取回能力。

[0032] 在PV0专用的植入物中,标记箍带可以固定在靠近中间折叠部的编织层之间。箍带 被牢固地保持并"隐藏"而不出现边或其它特征。因此,装置的远端端部在不需要另外紧固 箍带的情况下提供了光滑的输送/追踪外形。

[0033] 利用任意一种方式(即,开口、打结或安装箍带),避免了接头和其它增大输送外形 的特征处于球的一端。因此,折叠部提供了结构性优点(包括提高了可制造性)一一并降低 了因需要另外紧固编织物的端部而造成失败的可能性。此外,因为层之间匹配良好,对折的 管状原料获得了非常高的密度,同时保证一致的压缩和形状恢复性能。通过这样匹配,它们 在离开和进入/再进入导管时延伸/缩短大致相等的程度。

[°034] 本发明的一个变型利用匹配的编织层,并且在热定形(以及,最优地,紧固编织物 集线部)后通过磨削或者以其它方式切除而简单地消除折叠部。通过这样制备,植入物变得 更加的径向柔顺,如对于动脉瘤治疗所期望的那样。并且在不存在由细丝中的弯曲占据任 何额外空间的情况下,可进一步压缩球以便于通过最小的微导管(对于给定的编织物密度 而言)进行输送,从而实现进入更远的治疗位置。

[0035] 本发明的另一个变型可以利用或者可以不利用对叠方法进行构造。为了在不堆积 必须配合到微导管内腔中的额外层的情况下获得更高的编织密度,可以在植入物中替代地 结合另外的"帽"结构。为便于输送,这些特征依次压缩或颈缩(neck-down)。然而,在从微导 管中离开时,它们恢复到邻近植入物主体的位置。

[0036] 植入物的球本体和帽部通常由编织物的连续部分构造而成。中间标记部分可以设 置在这些元件之间。在装置的近端端部设有包括输送系统端口的集线部。

[0037] 在血流的闭塞很关键的端部处,编织物的近端帽向装置提供了额外的编织层。放 置在动脉瘤中的球的近端端部接触动脉瘤的开口和颈部。为了获得更好的流动闭塞,编织 帽可以是单层或双层编织物。可将一个或多个编织帽放置在球的近端端部(即,编织球可以 具有多达三个编织帽,并且如果可行的话还可以更多)。

[0038]编织帽不用作、并且不适于用作装置的锚固件。锚固件抓紧附接于其上的物体或 者阻止附接于其上的物体的运动。锚固某物意思是固定或紧固、或者牢固地附接一个物体。 球植入物并不利用编织帽锚固在动脉瘤或载瘤血管中。确切说,编织帽设计成或者邻接动 脉瘤中的球、或者只填充颈部区域。在任一种情况下,帽基本不接合球附近的血管组织。它 们充当提高球的栓塞能力的闭塞单元。

[0039]可以看到,提供了两种类型的带帽式编织球植入物。只适于配合到动脉瘤颈中的 帽通常是圆的(虽然它们可以是椭圆形的)并且可提供多个尺寸以配合不同的颈部尺寸,正 如植入物的球部也提供不同的尺寸一样。换言之,在植入物的整条线上,帽尺寸和球尺寸中 每一个的参数都可以变化。

[0040]适于与植入物的球部相邻地配合到动脉瘤中的帽更大并且形状确定成遵从球状 本体。输送它们需要或者在动脉瘤内压缩植入物的球部并在其中展开帽、或者将在动脉瘤 外展开帽并将它以展开状态推到动脉瘤内。

[0041]带有填颈式帽或盘的装置的输送以与不带有这些特征的编织球大致相同的方式 进行,只是,输送导管缩回得更多以暴露出帽、或者导管安置在动脉瘤颈的外侧(与在颈部 处的情况相比较)并且植入物从中挤出。当然,可以替代的采用这种动作的某些组合。

[0042]无论何种情况,如果获得了期望的配合,那么释放植入物。否则,将植入物从近端 集线部拉到输送导管中。一个或多个帽压缩成输送/取回鞘套的线性外形,然后是球部。 [0043]在本发明的又一种变型中,编织球与支架结合使用。球可以附接到支架上,它们一 起被输送。可替代地,框架或笼状物(cage)可以设置在支架的端部,当支架处于适当位置后 编织球被输送到其中。在任一种情况下,球和/或框架的尺寸可以确定成大致填充全部的动 脉瘤或者只填充颈部。无论那种情况,支架都将作为锚固件以防止球的移动。这种框架加 球的解决方案在阶段式输送方面提供了一定的优点,而球顶式支架提供了以单次输送实现 的一次性解决方案。在每个示例中,支架可以是自展开的(例如,包括超弹性的镍钛诺)或者 球囊式展开的(例如,包括不锈钢并且安装在PTCA式球囊上)。不管怎样,采用的编织球植入 物可以是在本申请或在上述交叉参引文献中所描述的那些编织球植入物中的任一个。

[0044] 本发明包括主题装置、包括该主题装置的成套工具、使用方法及制造方法。上面介 绍了该制造的多个方面。将参照下面的附图提供更详细的介绍。

[0045] 本申请要求以下美国专利申请的权益:在2008年4月21日提交的第61/046594和 61/〇4667〇号;在2〇〇8年7月 28日提交的61/〇83%7和61/〇83961以及在2009年1月15日提交 的 61/145,097-一每个申请的全部内容在此通过参引的方式并入。

附图说明

[0046] 在此提供的附图并不一定按比例绘制,出于清楚的目的放大了一些部件和部分。 其中:图1A和1B是侧截面图,分别不出了位于分叉部动脉瘤和侧壁动脉瘤位置处的编织球 植入物变型,其中,每个植入物中的折叠部分提供了无损伤组织接合部;图2是图1B中描绘 的植入物的放大图;图3A-:3C是尺寸逐渐变大的部分折叠式编织球的侧视立体图;图4A和4B 是侧截面图,示出了在分叉部动脉瘤位置内展开的近端折翼式编织球植入物变型;图5A是 支架锚固型编织球植入物的侧视图;图5B是带有用于接收编织球植入物的笼状物的支架的 侧视图;图 6是侧视图,示出了PVO应用中的部分折叠式编织球植入物;图7是图6中的植入物 的侧截面图;图SA和8B是处于制造阶段中的植入物的侧截面图;图9是植入物的侧截面图, 其中折叠部分用在装置的近端侧;图10A-10E是侧视图,示出了部分折叠式编织球植入物制 造的各个阶段;图11A和11B是端视图,示意性地示出了用于预先设定植入物折叠部形状的 技术;图12A和12B是侧截面图,示出了带有用于设定其形状的相关工具的部分折叠式编织 球植入物;图13A和13B是局部侧截面图,示出了替代的编织物/箍带附接方法;图14是局部 侧截面图,示出了集线部胶粘方法;图15是局部侧视图,示出了集线部修剪方法;图16是侧 截面图,示出了另一个部分折叠式编织球植入物变型;图17A-17D是侧视图,示出了图16的 实施方式的制造的各个阶段;图18是适于用在本发明中的输送系统变型的侧视图;图19A是 适于用在本发明中的另一个输送系统变型的远端端部的局部侧截面图;图i9B是从图19A所 示系统的植入物内观察的端视图;图20A-20F是植入物与根据图19A和10B所示方法构造的 系统相分离的局部透视图;以及图21是提供了根据本发明的治疗系统的概貌的透视图。 [00 47]可以根据所描绘的实施方式构思本发明的变型。因此,对附图中本发明各个方面 和元件的描述并不旨在限定本发明的范围。

具体实施方式

[0048]下面描述了本发明的多个示例性实施方式。对这些示例的参引具有非限制性的意 义。提供这些实施方式是为了示出本发明更广泛的应用方面。可对所描述的发明进行多种 变化并且可以替换成等同物而不偏离本发明的本质精神和范围。此外,可进行很多的修改 以使具体情况、材料、物质组成、工艺、工艺过程或步骤适应于本发明的目的、精神或范围。 所有这些修改都应落在此处所提出的权利要求的范围内。

[0049] 参照图1A,其示出了根据本发明的第一植入物20。第一植入物20由包括诸如镍钛 诺之类的弹性材料的管状编织原料形成,其在处于不受压缩/限制状态时限定开口体(一般 为圆形、球形、卵形、心形等)。

[0050] 植入物2〇设置在位于脉管分叉部4处的动脉瘤囊2内。优选地用下面详述的输送系 统通过市售微导管(未示出)经由主千血管 6 (例如,基底动脉)进入来输送植入物2〇。

[0051] 植入物的尺寸可选择成填充并稍微延伸出动脉瘤颈10,使得装置的近端端部22有 助于引导血液沿着构成植入物的编织物的表面流到分支动脉 8。球的远端端部呈圆顶形,邻 近编织物中的折叠部24,至少在受动脉瘤颈1〇处的流动冲击之处形成了双层结构26、28(分 别为内层和外层)。如图所示,一匝或多匝线圈30 (例如,铂丝)或者箍带(未示出)可提供远 端不透射线特征以标明植入物的位置。

[0052]在图1B示出的植入物40中,编织物中的折叠部24设置成半径更小。这里,植入物40 被接收在偏离血管14的侧壁动脉瘤12内。植入物的集线部42面对来自于血管进入和输送通 道并沿其流动的血液。

[0053]如图2中更易见的,植入物40包括结44,该结44封闭由折叠部限定出的孔口 46。不 透射线的(例如,铂)标记物48由该结保持。这种标记物并不会干扰植入物的用于输送的压 缩。球的近端端部的射线照相可视性可以单独地借助聚拢在一起的编织物的密度、或者可 以另外增加不透射线的(例如,铀)箍带50而获得。

[0054] 结44可包括任意的生物相容性的材料,包括不锈钢、钛、镍钛诺(可以是在体温时 呈马氏体特性的丝--通常称为"记忆合金(musclewire)")、缝合线等。使用线的一个优点 是它可以被简单地扭曲而与标记物一起紧固在其位置上。无论何种情况,如果期望半径尽 可能小的折叠,那么结的丝线应该很细(例如,直径大约为0.0015英寸或更小)。

[0055] 植入物40的另一个显著特征涉及邻近集线部42的区域。具体地,在编织物中设有 向外展开状或喇叭状收回外形52以帮助将装置收回到输送导管内,装置通过该输送导管前 进。接入端口54设置在集线部内。该端口接收输送系统接合部。下面提供输送系统的结构以 及植入物的其它任选细节。

[0056] 当然,图2示出了处于非限制状态下的球。当设置在动脉瘤内时,植入物将改为大 致依照动脉瘤的形状(例如,如图1A中示出的)。通常,植入物稍微尺寸偏大以向动脉瘤壁施 加一些小负载,从而帮助保持球的稳定位置。但是,特别是在侧壁应用(例如,如图1B中示出 的)中、如果期望任何集线部特征能够随球转动以追随血流的情况下,也可以有意地使球的 尺寸不足。

[0057] 根据期望的匹配,由医师选择的植入物可恰好是因动脉瘤形态的不同和/或医学 成像的限制而确定的输送时的正确尺寸。因此收回外形因便于植入物的取回而尤其有益。 可以放弃第一植入物并代之以具有更合适尺寸的第二植入物。图3A-3C按尺寸等级示出了 植入物60、62和64。当然,尺寸间隔可以改变。同样,形状可以改变。

[0058] 在所提供的三个示例中,能够注意到朝向球的中心保持了一致的孔尺寸。通常,期 望的是使得总的孔尺寸最小化。但是,在编织给定的编织原料管时所能够获得的编织物密 度受其直径和丝尺寸限制。因此,示出的三个球中的每一个由结合了不同数量的线或"端" 的编织物制成。例如,第一植入物62可以由在直径6mm的心轴上编织的对折的72端材料而制 成,第二植入物64由8mm心轴上的对折的96端编织物制成,而第三植入物64由在10mm心轴上 制成的对折的144端编织物制成。可替代地,更大的植入物(即,直径大约为10mm的植入物) 也可以由96端编织物制成,以保持更小的球囊外径(crossing prof i le)。具体地,当使用由 直径为0.001"的线制成的96端编织物时可获得0.027英寸的导管球囊外径。同样,在该范围 内的较小端(例如,直径大约为5mm),可改为选择64端编织物以获得0.021英寸的球囊外径。 [0059] 无论何种情况,在这些植入物内编织丝成对出现一一层26、28中每层各一根。虽然 编织物的组织结构经常是更加任意的,但是由于对于给定起始直径的编织物而言编织物密 度受到的限制,双/双重层结构一一平均上一一产生比用单层植入物所能实现的密度更高 的密度。

[0060] 在图4A和4B中分别示出的植入物70、72也可以是双层结构。在该情况下,它们将与 先前的植入物20/40/60具有相同的远端构型。如图所示,它们是单层装置,其中,远端端部 采用了嵌入式集线部74的形式。

[0061] 无论那种方法,植入物包括独特的近端端部构型。除了包括球或球状部80以外,每 个植入物还包括旨在改善其血流中断能力的折翼76、78。包括在植入物70中的折翼76旨在 用于动脉瘤内的应用中。为了如示出的那样输送它,首先将球或球状部输送到动脉瘤囊2 中。然后,装置的该部分受到压缩、同时仍然安装在推送器100上以展开其中的折翼部分。在 如图4a中示出的那样实现最终定位后,接收在集线部42中的推送器锁定构件释放。最后,推 送器缩回到输送导管110内。为了辅助该输送方法,可以设置一个或多个另外的不透射线特 征(例如位于球部80的近端端部处的箍带50),使得能够看到每个阶段的展开过程。

[0062]图4B中的植入物在输送中不需要这么复杂。因为折翼78的尺寸选择成仅用于填充 动脉瘤颈,所以它能够直接输送。同样,中间的不透射线特征可能是符合期望的,以确认恰 当的配合和/或展开。

[0063] 如所描绘的,相比于图4A的"橡果"状变型,图4B中示出的植入物的球-盘状变型 仅能够应用于颈部更小的动脉瘤。通常,盘的尺寸将不会显著大于载瘤/主干血管6的直径 和/或分叉区域4的尺寸。否则,脉管系统将妨碍展开。因此,盘的直径可限制为大约2.5mm到 大约5mm。

[0064] 在下面的植入物制造步骤的内容中能够更好地理解,可以使用简单的垫圈或 板--编织物在其上热定形--形成折翼78。另外,成形工具可以是弯曲的或碟状的,使得 折翼78更好地符合植入物主体的轮廓。

[0065]图4A的变型中的折翼76通常利用类似形状的凹陷/凸起模型形成。该折翼的尺寸 可以改变。如图所示,其外广度与装置的球部80的直径大致相同。它可以更小和/或覆盖植 入物70的近端侧的较小范围。通常,折翼70将覆盖本体80的至少大约三分之一、至多一半。 这样,在用于治疗宽颈动脉瘤时,更好地保证了颈部的充分覆盖。

[0066] 图5A是支架锚固式编织球植入物的侧视图。在治疗末梢动脉瘤时,支架12〇的尺寸 确定成锚固在主干血管中。这样,球部122的尺寸可确定成只填充动脉瘤的颈部而不是填充 其全部容积。对于形状不太规则的动脉瘤,这种方法是特别有利的。图5B中的装置以类似方 式使用,除了在将支架部分设置就位后,通过框架或笼状物124引入和保持编织球植入物。 [0067]框架可包括多个单独的线I 26,这些线I26在近端端部紧固于支架的集线部128、而 在远端端部紧固于另一集线部或平头(platten) 13〇。在另一个变型中,构成框架的线从与 支架单元和所包括的任何集线部相同的管中切割而来。它们在远端端部可终止于集线部 内,模制在不透射线箍带内、焊接到一起、通过胶粘剂紧固、或者通过一些其它的方法附接。 无论何种情况,它们通常(虽然不是必须)附接成形成封闭的框架。然而,可以设想开口的框 架-特别是线向后(即,向近侧地)钩弯以便于在安放时帮助"抓住"球的一种框架。

[0068]采用常用技术输送这些装置(g卩,在图5A和5B中示出的那些),只是,可将"防跳"/ 取回特征结合到支架部。无论何种情况,在支架中设有至少一排支架单元132以实现最低水 平的锚固;但是,可以采用多达五排或更多排支架单元132-一无论是否带有任何专门的输 送防跳/控制特征。

[0069] 虽然支架有利地包括三个用于球或球笼状物的支承延伸部136,但也可以采用更 多或更少的支承延伸部I36。只是,使用三个支承延伸部134提供了所能够获得的最小的稳 定结构。并且一旦它们结合到一起,它们像万向节那样操作以帮助使端部安装的球/框架与 待治疗动脉瘤成功地接合。

[0070]图6示出了主题植入物的一个完全不同的应用。即,植入物140在血管内(与邻近动 脉瘤中的血管相比较)展开以闭塞流动。如上引用,对于PVO使用来说,球的远端端部可包括 小凸块或奶嘴状部142。事实上,这种特征在如图7中示出的结构中是有利的。

[0071] 在该侧截面图中,编织交叉结构示出为在折叠部24处内翻(或外翻)。箍带144设置 在内编织层与外编织层之间。箍带封闭端部并作为标记物(尤其在它包括铂时)。粘合剂组 合物146 (例如,乐泰(LOCTITE) 3311或4014)可用于填充折叠部孔口中的任何余留内腔。与 其它植入物(包括图4A和4B中的那些)一样,该植入物在其近端、邻近集线部42处包括收回 外形部52。同样,它可包括集线部端口 54。

[0072]另外,植入物的两个端部可以由粘附剂或其它装置进行封闭/封堵。在没有输送系 统进入端口的情况下,可以利用简单的推送器(与完全可取回和/或可再定位的推送器相比 较)输送植入物。通过这样构造,不再需要近端集线部。事实上,可以简单地修剪编织物并将 其形状设定成在近端端部处并到一起和/或通过焊接、粘合剂或其它方式而紧固。

[0073]图8A和SB中示出了本发明的另一个可选的方面。即,首先形成折叠层植入物140, 而不采取使编织物折叠部24处的弯曲半径最小化的步骤。虽然其仍然可用,但是可能期望 的是修剪掉折叠层以产生如图8B中示出的改进的植入物140'。这样做消除了大体积,并且 还改变了植入物的输送特性,这在某些环境下可能是符合期望的。因为编织物的端部142可 以经过彼此而不露出底部(bottoraing-out),所以植入物变得更加径向柔顺并且能够配合 更宽范围的动脉瘤尺寸。因此,同一植入物140'能够填充更小的容积而不必从动脉瘤的颈 部伸出,如图8B中虚线所示。

[0074]无论何种情况,因为初始构造技术利用一个编织物管并且将其折叠以产生两个 层,所以这两个(现在隔开的)层很好地匹配于可预测的展开和收缩。此外,一旦移除了(例 如,通过切割、磨削等)任何的限制外形的弯曲,那么如果不期望上述可调特征,则可以重新 连接两个层。可局部使用聚氨酯涂层144或其它粘合剂(有利地,包括不透射线的钡粉或钽 粉)以便于在不使输送外形增大的情况下完成该动作。

[0075]而且,在另一些场合下一一尤其当折叠部以使线的弯曲半径/外形最小化的方式 形成时一一保持植入物中的折叠部提供了多个优点。即,包括折叠部的植入物可提供更好 的尺寸完整性和在需要的场合下提供径向力、在无需进一步处理过程(例如通过应用聚合 物)的情况下消除了植入物端部处的任何松散的纤维、提供了用于标记物的凹穴和/或用于 悬挂标记物的结等。

[0076] 此外,可以意识到植入物的折叠端并非必须设置在装置的远端端部处。相反,可以 将折叠部24用在近端侧,如图9所示。并且由折叠部形成的孔口46 (当由环、箍带或结150固 定时)提供了输送系统110的接合部。植入物的相反端可具有嵌入式集线部(例如,如图4A和 4B所示)或终止于更像图8B中所示的修剪后的端部142 (结合有聚合物或不结合有聚合物) 或者以其它方式构造。

[0077] 无论何种情况,图10A-10D示出了一种构造折叠部植入物的方法,其中使得折叠部 的外形最小化。本领域中普通技术人员能够理解,本方法的要素可应用到在此介绍的各种 植入物构型中。

[0078] 在这些图中,图10A示出了编织物2〇0的一部分,由缝合线202系到心轴204上。系的 结偏离编织物被切割的位置,使得当编织物如图10B中示出的那样内翻时,外层28延伸经过 内层26。产生了松弛的折叠部210并且编织物围绕植入物成形模型212。

[0079] 在图10C中,编织物围绕球模型212被包绕器214 (通常为铂丝或不锈钢线)拉伸和 紧固。还示出了压模型216、218(如箭头指示的那样夹持)。在热定形过程中(例如,对于镍钛 诺编织物,在550°C下大约5分钟),折叠侧模型216将折叠部压缩成尽可能小的外形。在该过 程中,烧掉了最初的结202(在由缝合线制成的情况下),从而消除了在折叠部处实现零或近 零半径弯曲的任何障碍。对侧的模型218可限定尖锐的肩部(用于在如下所述的"浮动层"球 中、球的端部将会被修剪掉并用作远端端部等情况下)或者在编织物中形成收回外形。

[0080] 在任意这样定形后,在如图10D所示那样最终移除了内模型后,则准备好装置成形 品(perform) 220。在该过程中,编织物的端部会被迫打开并且通常失去编织物的完整性/接 合。为了使得这种动作不会对植入物的完整性造成不良影响,结合到成形品220中的"尾部" 220应该足够长(例如,经常是大约2cm或更长)从而避免因拆开的编织物端影响植入物的目 标本体224而造成任何损坏。

[0081]如果植入物由包括氧化层的编织物形成,则随后对成形品进行腐蚀、然后钝化。但 是,如果在编织和任何热定形中一一所述热定形在盐浴坩埚(salt pot)、真空炉中进行,或 使用使氧化物的形成最小化的其它设备一一采用预腐蚀线,则该成形品可简单地经受硝酸 钝化。

[0082]即使采用了另外的中间处理步骤,图10E示出了一种可在形成集线部的过程中添 加箍带50的方式。具体地,在外层28由包绕器226束好后,可将箍带穿到该部分上。在下面没 有内层的情况下,束好的部分228配合到箍带50内,使得箍带的尺寸能够确定成当送到植入 物本体224附近位置时紧密配合两层编织物(以及可选的心轴230-一其作用在下面进行介 绍)。

[0083] 图11A和11B示出了在成形品定形过程中压缩形成折叠部以实现编织丝线的弯曲 半径最小化的一种替代性方法。这些图示出了用于预设定植入物折叠部形状的技术。在图 11A中,卷曲装置(例如,如能够从Machine Solutions Inc •等公司购得的卷曲装置)的楔形 部240接收编织物200,该编织物200被折叠以限定多个弯曲。心轴2似有利地设置在编织物 内。该心轴限制编织管的压缩,如图11B中指示的,当由楔形部形成的孔口 244封闭时需要使 弯曲半径变紧。折叠部的形状通过加热和/或加压和加热的结合而设定。热可通过喷火器、 炉子或者有利地通过使电流流过心轴而施加。在另一种方法中,以类似于上述卷曲楔形部 的方式采用多元件卡盘或夹套式装置。

[0084] 通过这样构形,可以在不使用缝合线结或压模型216的情况下形成基本如结合图 10A-10D所述的整体植入物。当然,可以采用在整个过程中都保留的永久性细线结来封闭球 的折叠端。可以通过将折叠的编织物简单地向后翻动以暴露出弯曲部来安装该结。可替代 地,可以通过针使它经由并围绕弯曲折叠部穿过并打结。

[0085] 在植入物整体的热定形过程中,对折叠部进行预处理或者压成形是有利的,特别 是对于折叠部附近区域要形成圆顶形的那些情况尤为如此。但是,当考虑到装置所期望的 用途(例如,PV0)而在其设计中可接受小凸块时,图12A和12B示出了另一种方法。具体地,如 图所示,海波管(hypotube) 250 (或者其它包括凹穴的成形模型)放置在编织物上的某一位 置上,在该位置编织物限定在箍带50之间和/或箍带与心轴204之间。另外,如图12B中示出 的,第二海波管252(或模型凹穴中的表面)能够抵接远端弯曲点254以进一步约束编织物, 用于精确定形。

[0086] 为了设定植入物或者其成形品220的其余部分的形状,图12A示出了利用近端喇叭 状模型256来设定光滑的收回外形。在图12B中,近端模型258设定紧的或尖锐的半径范围。 由于局部弯曲应力更大,所以这种形状可用于实现植入物中的更高的径向力。

[0087] 图12B中示出的植入物通过图中所示的其他显著特征寻求获得比图12A中更好的 锚固性能。即,沿着本为椭圆形装置的形状在植入物中设定的圆筒状箍带260形状产生边 262,边262与脉管组织相互作用,增大的局部应力以增强锚固性能。

[0088] 相对于先前描绘的圆球状球植入物,这两个植入物仍然共同拥有变平/减小的宽 高比。这种宽高比允许更大的尺寸偏大,用于将自展开植入物锚固在血管中以获得装置的 最终长度。考虑到以下情况,该事实是有利的:在神经血管缺陷的治疗中,闭塞的病灶长度 (focal length)经常很重要,以便在PV0应用中无意地阻挡相邻的分支血管。

[0089] 不论植入物的形式如何,当包括集线部以紧固编织丝时,必须解决一定的附接困 难。集线部必须牢固地紧固到编织物上并且可能需要使该特征的长度最小化。图13A和13B 是局部侧截面图,示出了可选的编织物/箍带的附接方法。在图13A中,箍带50被设定成在编 织物的修剪线之后。造成的小尾部270提供了可在其上施加胶粘剂272的表面。一旦固化(例 如,通过应用UV),则该胶粘剂被夹带到编织物中并形成箍带不能够通过的边274。如果不使 用胶粘剂,则可以通过激光熔化编织物而类似地形成用于箍带的千涉特征。在采用内箍带 276的情况下,这种激光应用可以将编织物焊接到内箍带276上。可以绕编织物沿径向方向 应用激光,或者轴向地横跨编织物的修剪面应用激光。

[0090] 特别是当利用激光能时,可以采用如图13B中示出的替代方法。这里,通过施加方 向为轴向地横跨箍带的边和编织物的面的激光能,可以将它们都焊接到一起。即使这样焊 接之后,也可以通过聚合物粘合剂272对形成的面进行密封。

[0091]图14示出了固定集线部的又一种方法。这里,依靠毛细作用使得胶粘剂/粘合剂穿 透箍带下面的编织物以形成粘结。将一滴(bead)胶粘剂280施加到编织物200的邻近箍带50 的暴露部分。不粘(例如,涂覆有PTFE)心轴230可定位在编织物内以便于在注入胶粘剂的编 织物中精确地限定内腔。该内腔有利地操作为输送系统端口。当粘合剂固化并移除心轴后, 产生尺寸精确确定的复合壁结构。

[0092] 可以通过如图示那样转动组件而绕编织物均匀地施加粘合剂。也可以利用其他方 法。在这样一种方法中,箍带中可包括多个可选的进入窗口 282以接收和分散粘合剂。也可 以可选地通过纸片或吸收纤维垫284将粘合剂从编织物200吸走(或者通过其它方法移除), 使得任何多余的用于确保编织物内腔覆盖和/或箍带 50粘接的渗透/流动粘合剂不会妨碍 植入物本体224的自展开行为。

[0093] 内箍带276的使用也是选择性的。虽然它占据了仅由编织物-胶粘剂形成的内腔中 保留的空间,但是对于分离系统接合部来说,在集线部组件 42中包括内箍带有时候可能是 符合期望的。

[0094] 还可以可选地使用辅助海波管2部。但是,该管提供了有用的柄或把手,对其进行 夹持以用于随后的修剪。特别对于这种用途来说,厚壁(例如,大于0.005"或更大)管可能是 符合期望的,因为它会产生额外的稳定性。与成为植入物一部分的箍带一样,海波管286可 包括用于施加粘合剂的一个或多个进入窗口 282。

[0095] 为了修剪植入物成形品220 (无论它是怎么成形的),图15示出了一种与图14中示 出的集线部固定方法配合良好的方法。具体地,将辅助海波管夹持在固定装置 29〇上,该固 定装置290安装在滑动部292上。可以提供侧向调节以便于使得锯片294 (通常是0.004-0.010英寸的金刚石层面轮)与在箍带和海波管2洲柄之间形成的间隙2%对准。一旦对准 (切割线可以位于间隙处,或者可将箍带本身切掉)后,将植入物剪下来。为便于处理,植入 物可至少部分地被限制在如图所示的鞘套298中。精确的切割/修剪允许箍带(在修剪或最 初安装时)的高度短至约0.010英寸。但是更保守的尺寸(例如,高度大约为〇.〇 2〇英寸)可能 是符合期望的,以保证编织物的保持及分离系统的强度。

[0096] 在完成切割后,可以通过对集线部的面进行磨削而进一步减小其长度。在移除心 轴(也在修剪过程中切除)并且在进行超声波清洗之后,可以用粘合剂密封集线部的面。 [0097]图16中示出了利用任一个所引用的集线技术生产的另一个植入物变型 3〇〇。图 17A-17D中显示了其制造中的独特的额外步骤。

[0098] 该植入物与上面介绍的那些植入物的不同之处在于它包括未在装置的各端紧固 的编织层。相反,内层26"浮动"。它的存在增大了植入物的密度,但是当球被压到鞘套中以 用于输送和/或收回时,该内层的靠近集线部42的纤维并没有被迫弯曲。这样,需要相对较 小的力来收回,即使当编织物在集线部外弯曲成大约90度时也这样(即,在设计中植入物本 体224的近端端部不包括收回外形)。 ^

[0099]为了产生这样的球:其内编织端302靠近集线部、在该位置处外编织层的密度最高 并且最适于防止单根丝线从内层穿透编织交叉结构,实施了一套精巧的制造过程。具体地, 在以如图17A中示出的植入物成形品220开始以后,如图17B中示出的,将编织物的外层从植 入物的目标本体 224上拉开或推离。如图17C中示出的,对编织物的内层进行修剪。可以采用 线钳、剪刀或其它的工具。最后,如图17D中示出的,使外层返回到其初始位置,并且进一步 处理植入物成形品。

[0100]这种进一步的处理可包括通过箍带捆扎(banding)/集线处理、修剪和/或打结而 将折叠部的孔口封闭。然而,可有利地在恢复外编织层的位置之前、折叠部24如图17B/17C 那样暴露在外时进行这种打结。

[0101]无论植入物的构造采用何种技术,这些植入物都能有利地安装到可释放的推送器 上。图18中的输送系统308包括带有切出窗口 314的海波管轴312。靠近球集线部的窗口 312 很重要,其它窗口仅是有利的。芯构件316 (有利地是镍钛诺带)从近端窗口 :312或切口引出 并在第二窗口 314处再进入。附接到海波管上的肩部/缓冲部316抵接集线部的近端端部50 以推动植入物40。可替代地,可以设置沿海波管的长度延伸到输送系统应变释放部31 8和/ 或集线部320的外套管(未示出)。为了能够将植入物收回到输送导管(未示出)中,芯构件 316接合集线部内腔的内表面(隐藏的)以保持植入物。

[0102] 为了能够释放,通过拉动手指柄322使芯构件缩回到海波管310中,以离开各个窗 口 312、314。此时,可通过使推送器缩回而使海波管离开集线部端口 54。

[0103]图19A和19B中示出了另一种可分离的输送系统330。它是全共轴设计,其中,拉动 控制线332以解除安装在锚固线33e上的头部334的干涉,否则不能够穿过集线部端口或内 腔54。因为将线直接拉出并且只定位锚固线头部以保证干涉(在图19B中清楚地示出),所以 需要付出的努力很小。至少在控制线上设置EPTFE涂层也是有益的。

[0104] 控制线332可延伸到或延伸超过锚固线头部334(在图19A中示出前一种情况)。另 一个选择是将控制线的长度限定为任何内箍带276的长度或者整个集线部42的高度尺寸 (如图19B中示出的)。还可注意到:图19A示出了推送器套管338与植入物集线部50之间的间 隙。这种表示只是出于说明的目的。

[0105] 无论何种情况,推送器套管内腔340和植入物集线部内腔/端口 52中的每一个的尺 寸优选地确定成使得线(控制线332和锚固线336)以紧密压实的布置被接收。通过这种方 式,植入物和推送器套管作为引导件,该引导件消除与线变得交织或缠绕相关的载入困难。 另外为了载入系统,通常以很轻的程度拉伸锚固线(在简单地粘合到把手中之前或者利用 把手设计中结合的偏置弹簧)以保证封闭植入物与推送器之间的任何间隙并且在使用中保 持封闭。

[0106]图20A-20F不出了处于使用状态的输送系统330的一个变型。分_系统的远端端部 示出为具有植入物的集线部42。图20A示出了互锁接合的推送器。图20B_2〇D示出了控制线 332的依次缩回。如图20E中示出的,也可以单独缩回锚固线336。但是,它可以替代地与分离 系统套管33S-起缩回。实际上,它可以附接到套管上。还有,能够意识到不需要一次只拉动 一根控制线。可以同时致动它们。无论何种情况,图20F中示出了植入物完全分离。

[0107] 最后,图21显示了包括植入物342和把手的治疗系统340的概貌。植入物342和把 手中的任一个或二者可根据此处的教导进行构造。示出的把手包括三个旋钮。两个旋钮344 连接到控制线(在视图中隐藏),而最后一个旋钮 346连接到锚固线(在视图中隐藏)。把手设 计中可包括可拆卸的锁定帽348以及应变释放部350。导管/推送器轴33 8可包括简单的伸出 部(例如,PTFE、FEP、TOEK等)、或者可以利用传统的导管构造技术进行构造并且包括衬垫、 编织物支承部和外套(未示出)。载入鞘套352通常设置在推送器轴上。有利地,载入鞘套是 可分离的,如所示出模型那样。

[0108]在从无菌包(未示出)中取出后,将植入物拉到载入鞘套352内。载入鞘套被接收在 用于输送植入物的导管的中心,并且植入物前进到导管内。然后,植入物可以前进到治疗位 置并在治疗位置处展开。或者在如图2〇A_ 2〇F中示出的那样最终分离之前,可将它取回以调 换成另一尺寸的植入物,或者在需要的情况下进行重新定位。

[0109]该主题方法可包括与植入物的定位和释放相关的每个医师动作。因此,隐含在植 入装置的定位和展开中的方法形成本发明的一部分。这种方法可包括将植入物放置在脑动 脉瘤内、或者放置在用于闭塞的载瘤动脉处、或者其它的应用中。在一些方法中,考虑了将 植入物引入到动脉瘤或载瘤动脉中的多种动作。

[0110] 更具体地,根据本发明的多个方法涉及到例如输送系统在到达治疗位置的过程中 的操作方式。另一些方法涉及将该系统准备好用于输送植入物一一例如将编织球附接到输 送系统一一的方式。此处的任何方法可以以所列举事件的任何逻辑上可能的顺序进行、以 及以事件的列举顺序进行、或者对这些事件或事件顺序略作修改。

[0111] 而且,设想到所述的本发明的变型的任何可选特征可以独立地、或者与在此描述 的任一个或多个特征相结合地进行阐释和要求保护。对单个事物的引用包括了存在多个相 同事物的可能性。更具体地,如这里及所附的权利要求中使用的那样,除非另外具体声明, 否则单数形式"一个"、"所述的"、和"该"包括多个参引物。换言之,冠词的使用考虑到了在 以上说明书以及以下权利要求书中的"至少一个"主题事物。还应当注意到权利要求可能撰 写成排除任何可选元件。因此,该声明旨在作为使用诸如"单独地"、"仅"等与权利要求条项 的列举相关的排它性术语、或者使用"否定性"限制的前提基础。

[0112] 在未使用这些排它性术语的情况下,在权利要求书中的术语"包括"应当考虑到包 括任何附加单元,而无论在权利要求书中是否列出给定数目的元件、或者特征的增加是否 会被视为改变权利要求书中所阐释元件的性质。除了此处具体限定的以外,在保持权利要 求有效性的同时,应当对在此使用的所有技术和科学术语给予尽可能广泛理解的含义。

[0113] 本发明的范围并不由所提供的示例和/或该说明书限定,而只是由权利要求语言 的范围限定。此处术语"发明"的使用并不旨在以任何方式限制权利要求的范围。确切地说, 应该认识到本"发明"包括在此明确描述或隐含的多种变型,包括本领域普通技术人员在阅 读本说明书后明显可知的那些变型。此外,它并不旨在使本说明书的任一部分(例如,发明 内容、具体实施方式、摘要、技术领域)相对于彼此或相对于权利要求书而言在描述本发明 时具有特殊意义。列出的所有参考文献通过援引的方式全文并入。虽然已经出于清楚理解 的目的对前述发明进行详细描述,但是可以设想可在所附权利要求的范围内实践某些修 改。

Claims (9)

1 • 一'种制造检塞装置的方法,所述方法包括: 反转管状编织物的一部分以绕所述编织物形成折叠部分、并且使所述部分的多个端部 朝向彼此; 保持每个所述折叠部分封闭并且保持第二部分远离所述多个端部以围绕模型定位所 述编织物; 设定装置本体的形状;以及 从所述编织物中移除所述模型。
2. 如权利要求1所述的方法,其中,所述模型通过所述第二部分移除。
3. 如权利要求1所述的方法,其中,在设定所述装置本体的形状前,将所述折叠部分设 定成压缩外形。
4. 如权利要求1所述的方法,其中,在设定所述装置本体形状的同时,将所述折叠部分 设定成压缩外形。
5. 如权利要求1所述的方法,还包括使箍带经过所述编织物端部前进到集线位置。
6. 如权利要求5所述的方法,还包括将包括邻近所述集线部的所述编织物端部的一段 长度的所述编织物修剪掉。
7. 如权利要求5所述的方法,还包括通过使粘合剂渗透所述箍带下面的所述编织物以 将所述箍带和所述编织物紧固到一起。
8. 如权利要求7所述的方法,其中,在渗透所述粘合剂时,不粘的心轴在所述编织物内 限定内腔。
9. 如权利要求5所述的方法,还包括沿着形成所述栓塞装置的所述编织物将粘合剂从 所述集线部外部的所述编织物上吸走。
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