CN101234046A - 用于修补血管畸形的可血管内递送的支架 - Google Patents
用于修补血管畸形的可血管内递送的支架 Download PDFInfo
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Abstract
一种专门设计用于最微小侵入性外科手术的可递送支架/移植物,用于治疗各种血管疾病,如动脉瘤、血管狭窄损伤和隐静脉移植,其包括最内层的管状构件和共轴线安置的至少另一层管状部件。在一实施方式中,长度为L1的最内层管状构件由编织相对稀少股线的高弹性金属合金丝的材料构成。编织物的斜度和纬线的密度(pitch and pick)使管壁具有相对大的穿孔,可让血流通过管壁并提供主径向支撑结构。长度L1的最内层管状构件的一部分被另一层编织的管状构件围绕着,该管状构件具有相对密的股线,因而基本上阻止血流通过该最内层管状构件的穿孔。此复合结构可伸长而缩小该支架/移植物的外径,使其可放入递送导管内腔中。然后将此导管通过血管系统向前推进到治疗部位,然后释放出支架/移植物,让其自身扩张抵住血管壁。公开了各种任选的实施方式从而可让本领域技术人员按照特定的应用确定设计。
Description
发明背景
I.相关申请的交互参考:本申请是2006年1月13日提交的待批申请号11/331.640的部分续展申请,出于任一目的将该申请内容纳入本文作参考。
II.发明领域:本发明一般涉及可在血管内递送的支架或移植物。具体说,本发明涉及除给血管搭桥或加衬外,通过修补用于治疗动脉瘤、损伤和隐静脉移植(saphenous vein grafts)的独特支架或移植物。虽然强调这类支架或移植物是专门设计用于治疗动脉瘤,特别是髂动脉瘤和腹主动脉瘤(AAA),但也公开了适用于隐静脉移植(SVG)、透析移植物和颈动脉的其它的实施方式。
III.现有技术的讨论:主动脉瘤是主动脉中的薄弱区域,而主动脉则是携带血液从心脏向身体其余部分递送的。主动脉从胸腔中的心脏向上延伸,然后弓形向下穿过胸腔(胸主动脉)进入腹部(腹主动脉)。腹主动脉的正常直径约1英寸(25mm)。随着血流通过主动脉,该薄弱区域外突象一气囊,如果气囊太大可能破裂。
最常见的主动脉瘤发生在肾动脉起源处下方的血管部分。动脉瘤可延伸至供应臀部和骨盆的血管,包括髂动脉。
一旦动脉瘤直径达到5cm(约2英寸),通常认为必须治疗以预防破裂。低于5cm的动脉瘤破裂风险低于病人常规外科手术带来的风险。治疗动脉瘤的目的是预防其破裂。一旦AAA破裂,存活的机会很低,所有动脉瘤破裂者中80-90%导致死亡。如果在破裂前检测到动脉瘤并进行治疗可避免这些死亡,理想地是早期(动脉瘤较小时)治疗,产生的风险较低。
大多数主动脉瘤发生在腹主动脉,主要原因是动脉粥样硬化。这是动脉壁中脂肪沉积导致弹性差和薄弱引起的疾病。动脉粥样硬化的主要危险因素是吸烟、高血压及遗传因素。
AAA可根据其发生时的症状作出诊断,但这常常太迟。常规体检和胸腹X-光检查通常也可发现AAA。检查时医生可在腹部触及感觉到博动性肿块。如果医生怀疑动脉瘤,则可能会要求他/她作超声波扫描检查。也可进行其它扫描,如计算机X线断层成象术(CT)和磁共振成象术(MRI)。这些扫描技术对动脉瘤精确定位非常有用。
治疗AAA的外科手术包括用合成的移植血管替换主动脉的患病节段,通常包括用其性能与正常健康的主动脉非常相似的弹性材料制成的管。大部分手术通常相当成功,死亡率在2%和5%之间。即使在手术时AAA破裂导致的死亡风险也只约为50%。
近年来,作为动脉瘤修补开腹手术的替代,血管外科医生采用了可在病人血管中伸展的细长导管将一种血管内支架/移植物递送到动脉瘤部位。通常外科医生要在病人腹股沟区作一小切口,然后插入含有塌陷的可自身扩张或含可扩张气球的支架/移植物的递送导管到动脉瘤搭桥部位,在该部位点递送的支架/移植物从递送导管远端伸出,使其扩张到接近主动脉的正常直径。当然这种支架/移植物呈管状结构,允许血流通过其内部并带走动脉瘤中的压力。随时间推移,支架/移植物的内壁可内皮化,支架的外壁与动脉瘤内壁之间的空隙被凝血块填塞,此时动脉瘤不再遭受主动脉血压压迫因而不会继续长大。
治疗AAA时,至关重要的是要精确安置支架或移植物,不能堵塞从腹主动脉分支的肾动脉血流。
安普雷兹(Amplatz)等人在美国专利6,932,837中描述了为在选择的血管或其它管状器官腔中移植设计的可塌陷的支架/移植物。此种支架/移植物包含多股形状记忆合金丝纺织或编织成的织物。这种织物形成为一管状,该装置二端是开口可让液体流经管状。该装置可纵向延伸从而减少其直径使其能插入到递送导管内腔中。当从递送导管远端伸出时,该支架/移植物能自身扩张到预定的外径,这足以接合待治疗管状脉管的管壁。
虽然’837专利中的此类装置总的适合用作冠脉支架,但不能很好适合AAA的血管内治疗。此装置虽纺织得均匀但金属丝密度不足,不能限制动脉瘤受到主动脉血压的作用,而这是必然的。如果此种支架/移植物也可能侵占肾动脉开口,那么它可限制流入肾脏的血流。
因此,需要采用在血管内安置支架/移植物治疗AAA,但不会不恰当地堵塞肾脏血流的装置。本发明提供了这种装置。
动脉瘤也可发生在胸主动脉中,其中手术不会涉及肾动脉,或身体的其它动脉。根据动脉瘤发生的部位与其它血管分支的关系,可能需要有不同的设计变化。某些病例中,不涉及分支血管,此时支架/移植物壁可以是完全均匀的。当涉及上主动脉时,所用支架/移植物的一部分,不论是近端、远端或二端之间的区域,与管壁含有小得多孔洞的剩余的支架/移植物相比,前者可能需要其管壁的一部分有较大的孔洞以允许足量的血流进入颈动脉。
不论所要治疗的动脉瘤部位是何处,都需要能够瘪塌至非常小的可递送直径的改进的支架或血管移植物,以减少接近护套尺寸而刺破动脉,损伤进入部位的血管,和提供对血管系统损伤较少的较小较易跟踪的递送系统。也需要一种外形小的支架或移植物,其提供血管支撑、能局限动脉瘤和可被快速内皮化的表面。本发明在此提供了这种益处。
在介入治疗心脏病领域,治疗血管系统狭窄损伤现已成为常规,包括隐静脉移植和颈动脉,采用气囊血管成型术治疗部分堵塞的血管,和在待治疗损伤的部位安置支架阻止血管再狭窄等的尝试。
这些方法中所用的支架必须能够呈直径减小的构型以便能通过引导的导管或动脉套管递送,而且能在引导导管的远端伸出时自扩张或“气囊扩张”。
在进行采用支架的气囊血管成型术时,常用西丁格(Seldinger)技术进入血管系统,和装有防止血流失的止血阀门的管状引导管通过穿刺创口从皮肤插入到动脉内。为了执行经皮进入而不是手术切开暴露股动脉的手术,大多数病人需要小于14Fr(通常为6-8Fr)的引导套管。引导套管越小,对组织的损伤就越少,其安置和术后的动脉穿刺闭合也越容易。某些病例中,用长的动脉套管替代短的血管进入套管,并提供递送装置到最靠近治疗靶部位的引导路径。在其它病例中,将引导导管插入引导套管中,通过血管系统递送,直到该引导导管的远端部分安置在所选择的动脉狭窄损伤开口处。近来,已有易操纵的套管出现,用于难以到达的碰到血管急转弯处的部位。
接下来,可沿套管内的引导线推进导管,或引导导管可通过动脉推进到治疗靶点。所述导管可以是气囊式导管,带有或不带有其上固定有气囊的气囊式可扩张支架,或者是用作自身可扩张支架的递送导管。治疗通常包括扩张狭窄的血管,然后在损伤处安置支架。气囊充气后将动脉血流受限的狭窄动脉区段直径扩张恢复到正常血流可通过。然后在已扩张的损伤部位安置气囊式可扩张或自身可扩张的支架,以维持血管壁处于扩张直径状态。安置的气囊式可扩张支架经气囊充气后即固定支撑于损伤处。通过拉回一覆盖安装在导管远端处的压缩的支架的套管,通常可安置好自身可扩张的支架。支架自身扩张后,可任选扩张气囊来固定支架确保完全张开。治疗后,从体内取出导管、引导线、套管等,通过压迫(切口部位)或其它可利用的密封方法密封血管穿刺部位。
经皮和血管内的血管成型术所用的支架有各种长度和直径,一般接近机体全身不同治疗部位血管损伤的长度和血管内径的正常范围。
在老化的移植物变得病态并填充有在安置支架或血管成型术期间可能易于发生栓塞的软凝块物质之后,先前经历过冠脉血管傍路移植术后,往往会发生隐静脉移植(SVG)治疗。这种血栓可能引起与移植物相连的下游冠状动脉堵塞。
因此需要一种能够在瘪塌状态中以非常小外形递送并可对SVG加衬、提供血管支撑、以及能防止SVG血管壁中形成的血栓到达冠状动脉的支架或移植物。
近年来另一种血管损伤治疗涉及颈动脉,特别是在气囊血管成型术后用自身可扩张支架治疗损伤时。因为这些动脉(颈内动脉)通向脑,如此损伤中常含有易碎的斑块,其可能破裂引起中风,在手术期间必须采用远处过滤或其它类似的防止堵塞/取出(栓子)方法来阻止血栓流入脑内。虽然手术期间这种保护方法有助于预防血栓(形成),但由于支架在血管壁表面张开的面积大,支架本身不可能提供足够的保护来预防使用支架手术后的血栓形成。
需要用于提供足够的血管支撑,以及手术完成后提供保护避免形成血栓从而预防中风,和不再安置程序性保护系统的颈动脉支架。
试图解决植入后锚固住现有技术的支架以阻止不希望发生的移动,目前采用的血管壁粘合钩,据信可伤害内皮和狭窄的损伤部位。因此仍需要能自身锚定而不需要刺伤组织的钩子的支架或移植物。
发明概述
本发明提供了用于治疗血管畸形,如AAA、胸主动脉或其它部位动脉瘤、隐静脉移植和损伤,特别是颈动脉损伤,的导管可递送血管内支架/移植物,该装置包括一具有第一长度的最内层管状结构件,该结构件被至少一个具有第二长度的另外的管状结构件围绕,以及将这些结构连接在一起的装置,借此至少一个所述最内层管状或另外的管状构件对该支架/移植物提供了比其它结构好得多的“径向支撑”。
所述最内层管状结构件包含多股编织的具有高弹性特征的金属丝,最好是形状记忆合金丝。如果选择最内层管状结构件作为此支架/移植物的主径向支撑部件(primary radial support member),那么,应选择好编织物的斜度和纬线的密度(pitch and pick)以形成足够大的孔洞而基本上不会防碍血流通过该最内层管状结构件的管壁。所述至少一个另外的管状结构件也包含多股编织的金属丝。如果另外的管状构件不是该支架/移植物的主径向支撑部件,则另外的编织管状构件中的丝线股也可包含形状记忆合金丝,此编织物的斜度和纬线的密度(pitch and pick)形成的孔洞足够小而实质性地阻碍血流通过其管壁。
选择主径向支撑部件的金属丝直径以提供对动脉血管壁的主径向支撑而锚定该支架/移植物,同时也能对毗连的管状构件施加足够的径向(radial)扩张力迫使这些结构相互贴紧和抵住血管壁。
非主支撑结构的金属丝直径远比包括径向支撑部件的金属丝直径和支数小。对该自身扩张结构而言扩张产生的径向扩张力已足够大。因为设计的本发明支架/移植物扩张后的直径大于治疗部位血管的直径,以及因为其存在细小孔,因而该支架/移植物可快速地发生内皮化。从而不需使用现有技术支架/移植物所需的锚定钩。
对于特殊用途,如果需要的话,考虑该支架的径向支撑结构可以是最内层管状结构、中间另外的管状构件或最外层另外的管状构件。与具有阻碍血流的小的编织开口的非径向支撑部件相比,该径向支撑部件具有较少但直径较大的金属丝,编织物中的孔洞不会阻止血流通过该编织物。在根据本发明所述构建的自身可扩张支架中,径向支撑层作用的幅射扩张力高于封堵层的径向扩张力约80-90%。
纵向拉伸共轴安置的最内层和其它层管状构件能将该装置的外径足够缩小,使其能装入小外形的血管内支架/移植物递送导管的内腔中。支架从递送导管中释放后允许其外直径自扩张回到由血管壁限定的其原始预定的直径。
为了在递送时该装置瘪塌期间和自身扩张期间实现所有层的长度相同,要求每根管状构件编织斜度(pitch)具有大致相同的角度。
还要求随着编织时从最内层管状构件末端向外层另一管状构件末端移动,编织层诸末端逐渐地向支架/移植物的中心移动。假定各层的金属丝斜度(pitch)基本相同,这使得在构建三层移植物时内层最长,中层略短,外层最短。这有利于最终的布局,即防止不同层的松散金属丝末端相互作用,防止在塌陷与扩张状态之间转变时随着各层的缩短和伸长各层轴向地滑动时另一层完全地展开。或者,可反过来加工,使最外层结构最长而最内层结构最短。在一具体结构形式中,该支架/移植物具有三层结构性编织部件,其中的中层结构是主径向支撑部件,最内层和最外层结构部件都比中层结构部件短。
在治疗AAA的优选实施方式中,最内层管状构件是支架/移植物主径向支撑部件,该编织层的远端伸展到远于至少另一层管状构件的远端。最内层管状构件的远端部分可覆盖病人腹主动脉内的肾动脉接合部,同时其它的管状结构围绕最内层管状结构,伸展到紧邻肾动脉处而搭桥腹主动脉瘤,但该支架/移植物不会阻断通向肾脏的血流。应认识到可构建近端和远端区段相反的此种支架/移植物来治疗位于肾动脉之上或上游的动脉瘤。
在动脉瘤的另一实施方式中,不存在重要的分支动脉或用于SVG时,最内层和至少另一层管状构件的长度基本相同,除了上述毗邻编织层末端替代外。
通常最好让径向最坚硬层展开为最内层管状结构,使得所有层全部并列抵住安置该植入管状的血管壁。然而,优选外层为径向最坚硬层而内层为较致密层从而可得到最优的愈合响应和较光滑的血管壁内表面以供内皮生长。为了在内表面和外表面上提供光滑的结构部件,具体采用的主径向部件应是中层结构部件,这样可能较好。选择取决于支架/移植物的具体用途。
在某些解剖位置,可能需要保护通过侧支血管的血流,同时提供血管支撑而排挤消除动脉瘤,或通过对该血管区段加衬来提供保护防止血栓形成。此种情况时,可能需要支架/移植物的中间层部分为主径向支撑管状构件,在金属丝之间含有较大孔洞让侧支动脉血流不受限制。此例中,所述支架/移植物应含有从中层推移的至少二层另外的管状构件,其含更多孔洞的部分,作为最内层结构或最外层结构或二者。如上所述,一个管状构件部件的金属丝末端应偏离毗邻管状构件的金属丝末端以有利于该支架/移植物的扩张和收缩。
附图说明
本领域技术人员通过以下优选实施方式的详细说明,特别是结合附图进行思考后,将会明白本发明的上述特征、目的和优点。
图1是安置在病人腹主动脉中搭桥动脉瘤的本发明支架/移植物的侧面立视图。腹主动脉显示为剖面图以便不阻挡支架/移植物。
图2是第二种实施方式的支架/移植物图,管状构件的长度与金属丝末端分叉大致相等。
图3第三种实施方式的支架/移植物图,支架/移植物中部比末端部分有更多的孔洞让血流通过;以及
图4A、B、C分别显示各种实施方式,其中,主径向结构部件是最内层、中层或最外层结构部件。
具体实施方式
参见图1,数字10指出了本发明优选实施方式的支架/移植物结构。显示支架/移植物10安置在含有动脉瘤14的腹主动脉12区段中。在其下端腹主动脉12分支为左右髂动脉16和18。图1也显示了通向肾脏(未显示)的肾动脉20和22。
支架/移植物10含有长度为L1的最内层管状构件23,和至少一个长度为L2的至少一个另外的管状构件26,二种结构都具有相似的预定直径。支架/移植物的L1全长为12-16cm,优选14cm;L2长8-12cm,优选10cm。
最内层管状构件包含第一多股编织金属丝股线24,优选形状记忆合金,如镍钛诺合金。该编织物所含有的最内层管状构件23具有预定纬线密度和斜度(pick and pitch)以确定穿通该结构壁的足够大孔洞,而不会实质上阻碍血流通过其孔壁。金属丝股线的直径范围为0.002-0.012英寸,设计管状构件23来提供该支架/移植物10自身扩张/血管支撑/锚定所需的足够的径向向外扩张力。这也可由移植物的外层提供,如果各层拴在一起由于与框架扩张相配套其它各层也扩张。
为获得在肾动脉区域中锚定该支架/移植物所需的足够血管支撑力,最内层管状构件自身扩张后的直径应大于天然血管的直径以产生保持力来抵靠住天然血管。支架/移植物的直径(与天然血管相比)超尺寸(oversizing)范围为10-20%。或者,该超尺寸范围可限制到涉及锚定在肾动脉附近的该装置部分。这可能有益,因为不要求将向外的幅射扩张力投到动脉瘤区段。
具有预定的长度(L2)和预定的直径的至少一个另外的管状构件26,共轴线安置围绕着最内层管状构件,此管状构件26的长度短于最内层管状构件23的长度。
围绕最内层管状的该另外的管状构件是由第二多股金属丝28编织而成,其金属丝的数量比组成最内层管状构件的第一层多股编织金属丝多得多。金属丝股28也是形状记忆合金,它们编织的纬线密度和斜度(pick andpitch)形成的孔足够小而基本上阻止了血流通过其管壁。
没有限制,最内层管状构件23可含有由诸如镍钛诺那样的形状记忆合金形成的36-144(优选72)股直径0.002-0.010(优选0.006)英寸的金属丝,其织成面积为0.001-0.002平方英寸,优选为0.0015平方英寸的穿孔(fenestrations)。另外的管状构件26可含72-288股,优选144股直径0.001-0.005英寸,优选0.0025英寸的金属丝纺线,编织形成的含有小得多的面积为0.0015-0.003平方英寸,优选0.0025平方英寸的穿孔(fenestrations),所述孔洞足够小而可阻止血流通过支架/移植物10的长度为L2部分的管壁。该编织物的内层与外层编织密度大约相等从而可获得所需的塌陷和扩张特性,如维持全长的均匀性。应注意本文所用的“基本上排除或阻止血流通过”是指最初(植入)后(该支架/移植物)短时间内,优选约15-45分钟内可出现血流,但机体的凝血机制,或蛋白质或在编织金属丝网上沉积的其它身体沉淀物质可能导致堵塞或血流阻塞。临床上,表现为造影剂注射15-45分钟后用荧光显微镜观察时看到没有造影剂流过该支架/移植物壁
根据本发明,通过让第二层的最外层编织管状构件30共轴线围绕着中间层管状构件26,而26又围绕最内层管状构件23,由此在长度L2上可提供甚至更小的孔。此第二层的最外层管状构件30也可伸展长度L2(由于金属丝末端分叉而略短),在编织构型上可与管状构件26相同,例如,由72-288,优选144股0.001-0.005英寸直径的镍钛诺(Nitinol)合金丝纺织而成,含有孔洞的区域面积为0.0001平方英寸(0.010英寸×0.010英寸)。
该支架/移植物管状构件层用直径范围为0.002-0.006,优选0.003英寸的射线不能透过的铂金丝线股在结构的中心围绕圆周的3-5部位处编织在一起。这有二个好处:可让移植医学专科医生知道移植物的中心在何处,以便将该支架/移植物对中在动脉瘤的中心,还让该多层编织物在瘪塌和扩张期间可更自由地移动。通过将此中心中各层贴合在一起,各层彼此的相对位置固定,然而各层的末端彼此之间可略为自由浮动而可产生全径向(full radial)布局但彼此没有较多干扰。如果各层之间的编织法不同,则沿长度在多个部位内编织此移植物可能形成束将导致各编织层之间发生高外形和不良的相互作用。也可在该支架/移植物中心以外的部位安排铂金丝或缎带编结,如果该编织管状构件的编结斜角(pitch)角度基本相同。也可采用其它类型的连接件如不能透过射线的铆钉来代替铂金丝/缎带。不是所有连接件需是不透射线的。
也可考虑如图1中37处的一种或多种径向(螺旋)缝针(radial stitches),用此法沿移植物全长(而不只是在中心处)将所有编织层紧密缝织在一起,以防止植入该装置时各层分离。此幅射编织物可以是镍钛诺合金,可以在移植物热定形的同时热定形。可将这些螺旋编织物缝制到具有与该编织层大约相同经纬度的编织物。可循着每三股或五股的丝线进行编结,例如以螺旋方式织进织出直到织完该编织物的全长。内层结构丝线可以是同样织法。
考虑可用授予可的斯安普雷兹(Curits Amplatz)的美国专利6,123,715(其内容纳入本文作参考)中所述的方法编织该支架/移植物10。可将最内层结构23编织成另外的管状构件26那样的管状织物。然后将外层编织管同轴地安置围绕在最内层管状构件上,围绕该支架/移植物的所需外径的园筒状心轴放置该组合物。然后加热此装配件至预定温度,时间长短应足够使该管状构件热定形到心轴直径。包括最内层管状构件23的股线的二相对游离端32、34可向外径向张开10-30度角而提供改进的与动脉内壁的并置。
从模具中取出后,可用一种或多种连接件如射线几乎不能透过的铂金丝或者编结缝线,将二层或多层同轴编织管缝织在一起。优选将此编织物放置在该管状结构长度的中点附近以利于用荧光显微镜检查,这样该支架/移植物可向近端和远端二个方向伸展插入到递送系统中。这样,编结缝线能成功地将同轴编织管结合在一起,还允许各共轴编织管随支架伸长而插入递送系统中时彼此可相对移动,随其自身扩张而贴合动脉壁和微微推动动脉瘤。
也考虑这样形成的支架/移植物可涂布一层能减少血栓或去除凝结物质的药物释放聚合物。可将所述药物释放聚合物选择性地涂布在敞开的织物或闭合的织物区段。
应用时,可按2005年5月4日安普雷兹(Amplatz)提交的题名为“支架和移植血管的可控递送系统”的待批专利申请号11/121,386中所述方式,将这样形成的支架近端附着在推进式导管上。然后将支架推入血管内递送导管的内腔中。用众所周知的西丁格(Seldinger)技术将递送导管导入病人,使引导丝通过血管系统直到该递送导管的远端抵达要治疗的动脉瘤附近。保持支架和推进式导管不动,向近端方向回抽递送导管使支架从递送导管的远端外突,并使支架自身扩张,其长度L2(图1)部分与动脉壁贴合在一起桥联所治疗的动脉瘤。最内层管状构件伸展超越另一管状构件远端的那部分可遮盖肾动脉20和22分支处。然而,由于内层管状构件的该部分为敞开编织结构,它不会显著阻碍血流流过肾动脉或产生狭窄。最内层管状构件23伸展超出了其它各层26、30的远端所提供的支架/移植物10的额外长度,起着在腹主动脉中更好稳定该支架/移植物、防止其在发生内皮化之前位移的作用。
图2、3和4A、B、C显示了另一种实施方式。在所有这些替代实施方式中,有关主径向支撑管状部件与非主径向支撑管状部件的金属丝数目、丝的直径、经纬度和穿孔(fenestration)大小的个别参数都相似,但不限于AAA支架/移植物优选实施方式(图1)中描述的那些参数。
在图2中,除了毗连结构的金属丝末端分叉外,最内层管状构件40和至少一个另外的管状构件42和44显示为具有基本上相同的长度,由此,金属丝末端分叉朝向该支架/移植物的中心。分叉长0.020-0.100英寸,优选约为0.050英寸。
在图3显示的支架/移植物的另一实施方式中,支架/移植物具有的一中间层部分50比末端部分52和54更敞开而便于流动。此优选实施方式中的中间层部分50只代表主径向支撑层,使至少一个另外的管状构件位于离更加敞开孔部分的两端上。此特定实施方式适合于,例如颈动脉损伤的应用,此时可将该支架/移植物放置在颈动脉分叉处,其有较大孔洞的中间层部分可让血流相对不受限制地从颈总动脉穿过该支架/移植物的壁流入外颈动脉56内,而轴向流前进到内颈动脉。
图4A、B和C显示其它替代实施方式,粗线代表主径向支撑结构,它在最内结构层(图4A)、中间结构层(图4B)和最外结构层(图4C)之间的位置可以不同。这些构造变化可以适用于图1、2或3中所示的任何实施例。
各实施方式可采用除镍钛诺合金以外的弹性材料,如弹簧不锈钢、钴铬镍合金(E1giloy)或高强镍(hastalloy)基合金,或金属与塑料纤维的混合物来替换地进行构造。可在同一层中混纺金属与塑料纤维。或者可构建各层由不同材料制作的该装置,根据所选的各种材料,可改变金属丝的直径、数目和经纬度以获得该支架/移植物所需的性能。在一实施方式中,如图2所示,各管状部件的末端金属丝任选热定形从支架/移植物纵轴向外幅射张开10-30度角,以改善末端金属丝在血管中的设置和锚定。这也使得其后导管通过支架/移植物的通道将在金属丝端部上挂起来变得不大可能。
考虑的另一实施方式是有二个另外的编织管状构件的支架/移植物,所述的另外的编织管状构件不是主径向支撑结构,变化之处在于,这两个另外的结构由部分折转的一种管状部件形成而产生二层。图4C显示的一种实施方式中,最内两层由一种长度21的单一管状编织物形成,其折转而形成长度L的结构。热定形该折叠的端部能顺利得到此结构。
该支架/移植物的另一实施方式与上述所有实施方式的区别只在于该支架/移植物递送方法不同。在所有上述实施方式中,该支架/移植物是由附连的管子、同心结构组成的一体的装置,同心结构在同一步骤中用单一的递送导管一起进行递送。而在此实施方式中,各管状构件一次一个地在体内分步进行递送,先递送最外层管状构件,然后递送先前结构内的紧邻层结构。此例中,各层结构不象图4中62所示通过缝合连接在一起,但各层结构都有缝在其中的射线不可透过的标记丝而有利于该结构安置在与治疗部位相关之处。这些标记可用作定位使手术者安置不同层结构时可将其置于横向于血管的同一平面中。与所有上述实施方式相同,通过一系列递送各层结构而在体内产生该支架/移植物,除非多层结构没缝合在一起,但通过最内层(优选也是主径向支撑层)的径向压力而被原位锁住。
为了与专利现状相一致和向本领域技术人员提供应用新原理构建和利用专门组件所需的信息,本文已按要求相当详细地描述了本发明。然而应理解到,本发明可用具体不同的设备和装置来实施,以及对设备和手术方法实现不同的改型,而不脱离本发明本身的范围。
Claims (25)
1.一种用于治疗血管壁中血管畸形的导管可递送的支架/移植物,其特征在于,它包括被至少一种另外的管状构件围绕的最内层管状构件,该构件,和至少一种连接所述最内层和另外的管状构件的连接件,所述结构包含编织的高弹性金属合金线,其中,所述编织的金属线可纵向伸展以缩小其径向尺寸而有利于其插入导管中和在治疗部位从导管中抽出,通过自身扩张与血管壁接合。
2.如权利要求1所述的导管可递送的支架/移植物,其特征在于,管状构件之一的长度为L1,并包括主径向支撑结构,允许血流相对不受限制地通过所述管状构件的壁,其中另一个管状构件长度为L2,它阻止血流通过其管状构件壁。
3.如权利要求2所述的导管可递送支架/移植物,其特征在于,长度L1大于长度L2.
4.如权利要求3所述的支架/移植物,其特征在于,长度为L2的管状构件安置在长度为L1的管状构件的一末端。
5.如权利要求1所述的支架/移植物,其特征在于,所述最内层管状构件被两个另外的彼此轴向地隔开一预定距离的管状结构围绕。
6.如权利要求2所述的支架/移植物,其特征在于,所述主径向支撑结构的尺寸相当于靶部位血管壁的尺寸而能提供所述支架/移植物的锚定。
7.如权利要求6所述的支架/移植物,其特征在于,所述主径向支撑结构的直径在不受约束时比靶部位血管壁的直径大10-20%。
8.如权利要求2所述的支架/移植物,其特征在于,所述L1与L2的长度基本相同。
9.如权利要求1所述的支架/移植物,其特征在于,所述高弹性金属合金是形状记忆合金。
10.如权利要求9所述的支架/移植物,其特征在于,所述的形状记忆合金是镍钛诺合金。
11.如权利要求2所述的支架/移植物,其特征在于,所述至少一种连接件通常安置在沿长度L2的中途。
12.如权利要求11所述的支架/移植物,其特征在于,所述至少一种连接件包括缝合线。
13.如权利要求12所述的支架/移植物,其特征在于,所述缝合线是用射线不可透过的材料制成
14.如权利要求1所述的支架/移植物,其特征在于,所述至少一种连接件包含沿该支架/移植物长度安置的连续螺旋方式缠绕的线。
15.如权利要求2所述的支架/移植物,其特征在于,所述最内层管状构件包含所述主径向支撑结构。
16.如权利要求2所述的支架/移植物,其特征在于,所述长度为L1的一个管状构件周围共轴地围绕着所述长度为L2的另一个管状构件。
17.如权利要求1所述的支架/移植物,其特征在于,所述最内层管状构件周围共轴地安置着多个管状构件,最内层管状构件的长度大于围绕的管状构件的长度,而围绕的管状构件长度从内向外逐渐变得更短。
18.如权利要求1所述的支架/移植物,其特征在于,所述最内层管状构件被多个共轴地安置的管状构件所围绕,最内层管状构件的长度小于围绕的管状构件的长度,而围绕的管状构件长度从内向外逐渐变得更长。
19.如权利要求2所述的支架/移植物,其特征在于,将血栓形成改善涂层选择性地施涂于长度为L1和L2的结构上。
20.如权利要求2所述的支架/移植物,其特征在于,长度为L1的结构显示出其开放面积约为0.001-0.002平方英寸的穿孔,而长度为L2的结构显示出其开放面积约为0.0001-0.0002平方英寸的穿孔。
21.如权利要求2所述的支架/移植物,其特征在于,长度L1的结构的径向扩张力超过长度L2的约80-90%。
22.如权利要求2或5所述的支架/移植物,其特征在于,可在体内顺次装配长度LI的结构和长度L2的结构。
23.一种治疗血管畸形的方法,其特征在于,该方法包括以下步骤:
(a)使由多条具有自我扩张能力的高弹性金属合金丝编织的第一管状构件从瘪塌纵向伸展状态变成宽松的幅射扩张状态,金属丝的数目、金属丝的直径和编织的经纬度可导致在该第一管状部件中形成大小可允许血流通过的穿孔;
(b)使由多条具有自我扩张能力的高弹性金属合金丝编织的第二管状构件从瘪塌状态变成所述宽松状态,第二管状构件的金属丝数目、金属丝直径和编织的经纬度可导致在该第二管状部件中形成大小基本上可堵塞血流通过的穿孔;
(c)将所述第一和第二管状构件以相互共轴的关系安置;
(d)将步骤(c)所述结构以所述的塌陷状态加载安置到血管递送套管中;
(e)将该血管递送套管送到血管畸形处的远端;
(f)使步骤(c)所述的结构从递送套管的远端伸出,让步骤(c)所述结构自身扩张而搭桥连接血管畸形处。
24.如权利要求23所述的方法,其特征在于,当第一和第二管状构件以共轴关系相互安置时,第一管状构件提供了大部分的幅射张力。
25.如权利要求23所述的方法,其特征在于,所述的幅射张力足以卡住所述管状构件使其安置在血管畸形处。
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JP4801655B2 (ja) | 2011-10-26 |
MX2007012827A (es) | 2009-02-13 |
AU2007221953B2 (en) | 2009-11-12 |
US8778008B2 (en) | 2014-07-15 |
EA200800084A1 (ru) | 2008-08-29 |
KR101030945B1 (ko) | 2011-04-28 |
SG144793A1 (en) | 2008-08-28 |
JP2008173461A (ja) | 2008-07-31 |
KR20080067953A (ko) | 2008-07-22 |
CN101234046B (zh) | 2012-05-30 |
WO2008118132A1 (en) | 2008-10-02 |
CA2607516C (en) | 2010-03-30 |
CO6200110A1 (es) | 2010-09-20 |
BRPI0705977A2 (pt) | 2009-06-13 |
CA2607516A1 (en) | 2008-04-28 |
EA012352B1 (ru) | 2009-10-30 |
AU2007221953A1 (en) | 2008-07-31 |
US20070168019A1 (en) | 2007-07-19 |
WO2008118132B1 (en) | 2008-11-27 |
EP1946721A1 (en) | 2008-07-23 |
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