CN101917929A - 用于低型面经皮递送的模块化脉管移植物 - Google Patents

用于低型面经皮递送的模块化脉管移植物 Download PDF

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CN101917929A
CN101917929A CN2008801103972A CN200880110397A CN101917929A CN 101917929 A CN101917929 A CN 101917929A CN 2008801103972 A CN2008801103972 A CN 2008801103972A CN 200880110397 A CN200880110397 A CN 200880110397A CN 101917929 A CN101917929 A CN 101917929A
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graft
fluid flow
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迈克尔·V·霍博托夫
罗伯特·G·沃利
约瑟夫·W·汉弗莱
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TriVascular Inc
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Abstract

本发明提供一种混合模块化脉管内移植物，其中主要移植物的大小经设计以跨越较大百分比的患者中的目标脉管损伤的至少一部分。移植物延伸部可紧固到所述主要移植物以延伸所述主要移植物且提供密封功能以用于某些应用。

Description

用于低型面经皮递送的模块化脉管移植物
技术领域
背景技术
动脉瘤是一种医疗状况，其一般由患者的动脉壁的扩展和弱化指示。动脉瘤可形成于患者身体内的各个部位处。主动脉的扩展和弱化显现出胸主动脉瘤(TAA)或腹主动脉瘤(AAA)，这是严重的且危及到生命的状况，一般对此状况指示干预。治疗动脉瘤的现存方法包含侵入性外科手术，其中对有病的脉管或身体内腔进行移植物替换或用移植物来加强脉管。
归因于此疾病的外科修复所固有的风险因素以及长期的住院和痛苦的复原，用以治疗主动脉瘤的外科手术可能具有相对高的发病率和死亡率。对于TAA的外科修复来说尤其如此，所述TAA的外科修复一般被视为涉及较高的风险，且与AAA的外科修复相比更困难。在W.B.Saunders公司于1986年出版的医学博士邓顿·A·库雷的标题为“主动脉瘤的外科治疗(Surgical Treatment of Aortic Aneurysms)”的一书中描述了涉及AAA的修复的外科手术的一实例。
归因于主动脉瘤的外科修复的固有风险和复杂性，脉管内修复已变为广泛使用的替代性疗法，在治疗AAA的过程中更为显著。在放射线学(1987年5月)的劳伦斯·Jr等人的“经皮脉管内移植物：实验评估(Percutaneous Endovascular Graft：ExperimentalEvaluation)”中以及放射线学(1989年3月)的米里奇等人的“用于主动脉瘤的经皮放置的脉管内移植物：可行性研究(Percutaneously Placed Endovascular Grafts for AorticAneurysms：Feasibility Study)”中示范了此领域中的早期工作。用于AAA的脉管内治疗的市售的内支架包含由明尼苏达州的明尼阿波利斯市的Medtronic公司制造的AneuRx
Figure GPA00001084380100011
支架移植物、由印第安纳州的布鲁明顿市的Cook公司销售的Zenith
Figure GPA00001084380100012
支架移植物系统、由加利福尼亚州的欧文市的Endologix公司制造的PowerLink支架移植物系统，以及由特拉化州的纽华克市的W.L.Gore & Associates公司制造的Excluder
Figure GPA00001084380100014
支架移植物系统。用于治疗TAA的市售的支架移植物是由W.L.Gore & Associates公司制造的TAGTM系统。
当通过导液管或其它合适的仪器来部署装置时，有利的是具有柔性且低型面的支架移植物和递送系统以用于穿过各种导引的导液管以及患者的有时曲折的解剖。许多现存的用于治疗动脉瘤的脉管内装置和方法(虽然代表了与先前的装置和方法相比显著的进步)使用具有相对大的横向型面(常高达24弗伦奇)的系统。而且，此类现存系统具有比所要的侧向硬度大的侧向硬度，其可使递送过程复杂化。另外，支架移植物的大小对于实现良好的临床结果是重要的。为了适当地设计支架移植物的大小，归因于不同的患者体型和脉管形态，治疗机构通常必须维持支架移植物的大且昂贵的库存，以便适应不同大小的患者脉管。或者，必须使干预延迟，同时等待制造出定制大小的支架移植物且发送到治疗机构。如此，对动脉瘤的最低程度侵入性脉管内治疗不可用于原本将受益于此手术的许多患者，且可更难以对那些指示所述手术的患者实行。尚需要的是支架移植物系统和方法，其可适于较广范围的患者解剖且可使用柔性低型面系统来安全且可靠地部署。
发明内容
模块化脉管内移植物组合件的某些实施例包含由柔软的移植物材料形成的分叉的主要移植物部件，其在其中具有主要流体流动腔。所述主要移植物部件还可包含：同侧支腿，其具有与所述主要流体流动腔连通的同侧流体流动腔；对侧支腿，其具有与所述主要流体流动腔连通的对侧流体流动腔；以及可膨胀通道网，其安置于所述主要移植物部件上。所述可膨胀通道网可安置于主要移植物部件上的任何地方，包含同侧和对侧支腿。所述可膨胀通道网可经配置以接受可硬化的填充物或膨胀材料以在所述可膨胀通道网处于膨胀状态时向所述主要移植物部件提供结构刚性。所述可膨胀通道网还可包含安置于所述主要移植物部件的近端部分上的至少一个可膨胀套头，其经配置以密封患者的脉管的内表面。所述填充物材料还可具有瞬时的或长期的射线不透性以促进将模块化肢体放置到主要移植物部件中。近端锚部件可安置在主要移植物部件的近端处且可紧固到所述主要移植物部件。近端锚部件可具有以支柱紧固到自膨式远端支架部分的自膨式近端支架部分，所述支柱具有与邻近于所述支柱的近端支架部分或远端支架部分的横截面面积大体上相同或比其大的横截面面积。其中安置有流体流动腔的至少一个同侧移植物延伸部可与密封到主要移植物部件的同侧支腿的流体流动腔且与其流体连通的移植物延伸部的流体流动腔一起部署。其中安置有流体流动腔的至少一个对侧移植物延伸部可与密封到主要移植物部件的对侧支腿的流体流动腔且与其流体连通的移植物延伸部的流体流动腔一起部署。对于某些实施例，当移植物延伸部处于部署状态时，移植物延伸部的外表面可密封到主要移植物的对侧支腿的内表面。对于某些实施例，同侧支腿和对侧支腿的轴向长度可足以提供与移植物延伸部的外表面的足够的表面区域接触，以提供充分的摩擦力来将移植物延伸部固持在适当位置。对于某些实施例，同侧和对侧支腿可具有至少约2cm的轴向长度。对于某些实施例，同侧和对侧支腿可具有约2cm到约6cm，更具体来说，约3cm到约5cm的轴向长度。
模块化脉管内移植物组合件的某些实施例包含由柔软的移植物材料形成的具有约5cm到约10cm的轴向长度的分叉的主要移植物部件。所述主要移植物部件具有：其中的主要流体流动腔；同侧支腿，其具有与所述主要流体流动腔连通的同侧流体流动腔且具有至少约2cm的轴向长度；对侧支腿，其具有与所述主要流体流动腔连通的对侧流体流动腔且具有至少约2cm的轴向长度。所述主要移植物部件还包含可膨胀通道网，其安置于所述主要移植物部件上，包含同侧和对侧支腿，所述可膨胀通道网经配置以接受可硬化的填充物材料以在所述可膨胀通道网处于膨胀状态时向所述主要移植物部件提供结构刚性。所述可膨胀通道网还可包含安置于所述主要移植物部件的近端部分上的至少一个可膨胀套头，其经配置以密封患者的脉管的内表面。近端锚部件可安置在主要移植物部件的近端处且紧固到所述主要移植物部件。所述近端锚部件可具有以支柱紧固到自膨式远端支架部分的自膨式近端支架部分。其中安置有流体流动腔的至少一个同侧移植物延伸部可使移植物延伸部的流体流动腔密封到主要移植物部件的同侧支腿的流体流动腔且与其流体连通。其中安置有流体流动腔的至少一个对侧移植物延伸部可使移植物延伸部的流体流动腔密封到主要移植物部件的对侧支腿的流体流动腔且与其流体连通。
用于治疗患者的方法的某些实施例包含提供含有径向受约束的分叉的主要移植物部件的递送导液管。所述主要移植物部件可由柔软的移植物材料形成，其在其中具有主要流体流动腔且其具有：同侧支腿，其具有与所述主要流体流动腔连通的同侧流体流动腔；以及对侧支腿，其具有与所述主要流体流动腔连通的对侧流体流动腔。所述主要移植物部件还可包含可膨胀通道网，其安置于所述主要移植物部件上。可膨胀通道网的可膨胀通道可安置于主要移植物部件的任何部分上，包含主要移植物部件的同侧和对侧支腿。所述主要移植物部件还可包含近端锚部件，其安置在主要移植物部件的近端处且紧固到所述主要移植物部件。所述近端锚部件可具有紧固到自膨式远端支架部分的自膨式近端支架部分。所述递送导液管可轴向定位在患者的脉管系统内，使得所述递送导液管内的主要移植物部件与患者的主动脉的脉管缺陷以同延方式安置。一旦已实现此定位，所述近端锚部件可经部署以便径向扩展并啮合患者的脉管系统的内表面，且将近端锚部件锚定到患者的主动脉。其后，主要移植物部件的可膨胀通道网可以膨胀材料膨胀，以便提供主要移植物部件的更具机械刚性结构。对于某些实施例，可膨胀通道网的膨胀还可提供主要移植物部件的可膨胀套头的外表面与患者身体内腔的与所述可膨胀套头接触的内表面之间的密封。对于某些实施例，可使用可硬化的填充物材料，其可在可膨胀通道网的膨胀之后呈现或更具坚固的配置，以便提供额外的机械刚性以及防止填充物材料的泄漏。某些实施例还可采用射线不透性膨胀材料以促进对填充过程和后续的移植物延伸部的啮合的监视。含有径向受约束的自膨式对侧移植物延伸部的第二递送导液管可随后轴向定位在主要移植物部件的对侧支腿中，其中对侧移植物延伸部的近端部分与主要移植物部件的对侧支腿的内部流体流动腔轴向重叠，且对侧移植物延伸部的远端部分与患者的对侧髂动脉的一部分轴向重叠。可通过经皮进入或用递送鞘等从患者的对侧股动脉进行股动脉剖开术而实现对主要移植物部分的对侧支腿的进入。一旦适当地定位，通过释放第二递送导液管的径向约束，可部署自膨式对侧移植物延伸部。当对侧的移植物延伸部在向外径向定向上自膨时，可在对侧移植物延伸部的内部流体流动腔、对侧支腿的流体流动腔与对侧髂动脉的流体流动腔之间形成密封。含有径向受约束的自膨式同侧移植物延伸部的第三递送导液管也可轴向定位在主要移植物部件的同侧支腿中，其中同侧移植物延伸部的近端部分与主要移植物部件的同侧支腿的内部流体流动腔轴向重叠，且同侧移植物延伸部的远端部分与患者的同侧髂动脉的一部分轴向重叠。随后通过释放径向约束，可部署自膨式同侧移植物延伸部，以便在同侧移植物延伸部的内部流体流动腔、同侧支腿的流体流动腔与同侧髂动脉的流体流动腔之间形成密封。可以任一次序递送和部署同侧和对侧移植物延伸部。
移植物延伸部的某些实施例包含：安置在其中的流体流动腔；至少一个可渗透PTFE材料层；至少一个半渗透或大体上不可渗透PTFE材料层，其具有不可辨识的节点和原纤维结构；以及插入的自膨式支架，其由细长的弹性元件形成，所述弹性元件以多个纵向隔开的匝螺旋地缠绕成安置于至少一个外部PTFE材料层与至少一个内部PTFE材料层之间的开放管状配置。
通过以下结合随附的示范性图式进行的详细描述，将更加明白实施例的这些特征。
附图说明
图1是模块化移植物组合件的正视图。
图1A是模块化移植物组合件的近端锚部件和连接器环的正视图。
图2是沿着图1的线2-2截取的图1的模块化移植物组合件的横向横截面。
图3是沿着图1的线3-3截取的图1的模块化移植物组合件的横向横截面。
图4是沿着图1的线4-4截取的图1的模块化移植物组合件的移植物延伸部的横向横截面。
图4A是由图1中的画圈的部分4A-4A指示的图1的移植物组合件的移植物延伸部与同侧支腿之间的接合点的放大视图。
图5A是由图1中的画圈的部分5A-5A指示的图1的近端锚部件与连接器环之间的接合点的放大视图。
图5B是在没有线圈部件的情况下近端锚部件的连接器元件与连接器环之间的接合点的分解视图。
图6A是由图1中的画圈的部分6A-6A指示的图1的近端锚部件的远端支架部分与近端支架部分之间的接合点的放大视图。
图6B是沿着图6A的线6B-6B截取的图1的模块化移植物组合件的近端锚部件的横向横截面。
图6C是沿着图6A的线6C-6C截取的图1的模块化移植物组合件的近端锚部件的横向横截面。
图6D是沿着图6A的线6D-6D截取的图1的模块化移植物组合件的近端锚部件的横向横截面。
图7到图14说明模块化移植物系统在患者的脉管系统内的部署序列。
图15是移植物延伸部的一实施例的正视图。
图16是沿着图15的线16-16截取的图15的移植物延伸部的横向横截面图。
图17A到图17E说明移植物延伸部配置的实施例。
具体实施方式
本发明的实施例一般针对于用于治疗患者的身体的流体流动脉管的方法和装置。某些实施例特定地指示对血管的治疗，且更具体来说，对例如腹主动脉瘤等动脉瘤的治疗。
模块化脉管内移植物组合件的某些实施例可包含由例如ePTFE等柔软的移植物材料形成的分叉的主要移植物部件，其在其中具有主要流体流动腔。所述主要移植物部件还可包含：同侧支腿，其具有与所述主要流体流动腔连通的同侧流体流动腔；对侧支腿，其具有与所述主要流体流动腔连通的对侧流体流动腔；以及可膨胀通道网，其安置于所述主要移植物部件上。对于某些实施例，所述主要移植物部件可具有约5cm到约10cm，更具体来说，约6cm到约8cm的轴向长度，以便跨越患者主动脉的动脉瘤，而不使患者的髂动脉直接与主要移植物部件的支腿啮合。
所述可膨胀通道网的可膨胀通道可安置于主要移植物部件的任何部分上，包含同侧和对侧支腿。所述可膨胀通道网可经配置以接受可硬化的填充物材料以在所述可膨胀通道网处于膨胀状态且膨胀材料已固化或硬化时向所述主要移植物部件提供结构刚性。可使用射线不透性膨胀材料以促进对填充过程和后续的移植物延伸部的啮合的监视。所述可膨胀通道网还可包含安置于所述主要移植物部件的近端部分上的至少一个可膨胀套头，其经配置以密封患者的脉管(例如，主动脉)的内表面。
近端锚部件安置在主要移植物部件的近端处且紧固到所述主要移植物部件。近端锚部件具有以支柱紧固到自膨式远端支架部分的自膨式近端支架部分。所述支柱的某些实施例可具有与邻近于所述支柱的近端支架部分或远端支架部分的横截面面积大体上相同或比其大的横截面面积。此配置可用于避免近端锚部件或耦合其组件的支柱中的集中应力点。对于某些实施例，近端锚部件的近端支架进一步包含多个倒钩，所述多个倒钩具有尖锐的组织啮合顶端，其经配置而以经部署的扩展状态在径向向外方向上延伸。对于某些实施例，近端锚部件包含4个冠状近端支架部分和8个冠状远端支架部分，其可由例如超弹性NiTi合金等超弹性合金制成。
其中安置有流体流动腔的至少一个同侧移植物延伸部可与密封到主要移植物部件的同侧支腿的流体流动腔且与其流体连通的移植物延伸部的流体流动腔一起部署。另外，其中安置有流体流动腔的至少一个对侧移植物延伸部可与密封到主要移植物部件的对侧支腿的流体流动腔且与其流体连通的移植物延伸部的流体流动腔一起部署。对于某些实施例，移植物延伸部可包含插入的自膨式支架，其安置在柔软的移植物材料层的至少一个外层与至少一个内层之间。安置在移植物材料的外层与内层之间的所述插入的支架可由细长的弹性元件形成，所述弹性元件以多个纵向隔开的匝螺旋地缠绕成开放管状配置。对于某些实施例，所述插入的支架可包含例如超弹性NiTi合金等超弹性合金。另外，对于某些实施例，每一移植物延伸部的移植物材料可进一步包含至少一个具有低渗透性的轴向区。
对于某些实施例，当移植物延伸部处于部署状态时，移植物延伸部的外表面可密封到主要移植物的对侧支腿的内表面。对于某些实施例，同侧支腿和对侧支腿的轴向长度可足以提供与移植物延伸部的外表面的足够的表面区域接触，以提供充分的摩擦力来将移植物延伸部固持在适当位置。对于某些实施例，同侧和对侧支腿可具有至少约2cm的轴向长度。对于某些实施例，同侧和对侧支腿可具有约2cm到约6cm，更具体来说，约3cm到约5cm的轴向长度。
图1到图6展示用于治疗腹主动脉瘤的模块化移植物组合件10的分叉的实施例。移植物组合件10包含分叉的主要移植物部件12、同侧移植物延伸部14和对侧移植物延伸部15。主要移植物12具有壁部分16，其定界安置于其中的主要流体流动腔18。主要移植物12的同侧支腿20具有同侧端口22和同侧流体流动腔24，所述同侧流体流动腔24与主要流体流动腔18和同侧端口22流体连通。主要移植物12的对侧支腿26具有对侧端口28和对侧流体流动腔30，所述对侧流体流动腔30与主要流体流动腔18和对侧端口28流体连通。主要移植物12、同侧支腿20和对侧支腿26形成分叉的“Y”状配置。
主要移植物12的主要流体流动腔18(图2中所示)一般可具有分别比同侧支腿20或对侧支腿26的流体流动腔24和30(图3中所示)的横向尺寸和面积大的横向尺寸和面积。近端锚部件32安置于主要移植物12的近端31处。近端锚部件32包含由具有大体上蜿蜒形状的细长元件形成的近端自膨式支架32A，所述细长元件在任一端处具有四个冠或顶点。近端支架32A的每一近端顶点或冠耦合到8冠远端自膨式支架32B的交替的远端冠或顶点。所述远端自膨式支架由具有大体上蜿蜒形状的细长元件形成。远端支架32B的远端可机械地耦合到连接器环，所述连接器环嵌入在主要移植物12的近端的移植物材料中，或直接耦合到主要移植物的近端边缘区中的穿孔。连接器环的实施例可为大体上圆形形状，其围绕圆周具有规则的波动，所述波动可为大体上正弦形状。近端支架32A包含向外延伸的倒钩33，对于某些实施例，倒钩33可与支架的支柱一体形成，所述倒钩33具有尖锐的组织穿透顶端，其经配置以穿透到腔的内表面的组织中，近端支架32A在所述腔内部署成扩展状态。虽然近端锚部件32展示为包含自膨式支架32A和32B，但可使用类似的支架，其经配置而以由可扩展气囊从支架32A和32B中的任一者或两者内的扩展所产生的向外径向压力而无弹性地扩展。耦合到近端支架32B的连接器环也可为可无弹性地扩展。
关于本文中所论述的移植物实施例，例如移植物组合件10和其组件，以及移植物延伸部14和15，术语“近端”是指朝向患者心脏的位置，且术语“远端”是指远离患者心脏的位置。关于本文中所论述的递送系统导液管和其组件，术语“远端”是指远离正使用导液管的操作者而安置的位置，且术语“近端”是指朝向所述操作者的位置。
同侧移植物延伸部14具有安置于其中的流体流动腔44。同侧移植物延伸部14具有外表面，所述外表面的大小可经设计且所述外表面可经配置以密封到主要移植物的同侧支腿的内表面，其中同侧移植物延伸部14的内部流体流动腔44与同侧支腿20的流体流动腔24流体连通。通常，当移植物延伸部14处于部署状态时，移植物延伸部14的外表面46可密封到主要移植物12的同侧支腿20的内表面48。对侧移植物延伸部15具有安置于其中的流体流动腔45。对侧移植物延伸部15具有外表面47，所述外表面的大小可经设计且所述外表面可经配置以密封到主要移植物12的对侧支腿26的内表面50，其中内部流体流动腔45与对侧支腿26的流体流动腔30流体连通。通常，当移植物延伸部15处于部署状态时，移植物延伸部15的外表面47可密封到主要移植物12的对侧支腿26的内表面50。对于某些实施例，同侧支腿20和对侧支腿26的轴向长度可足以提供移植物延伸部14和15的外表面46和47与支腿20和26的相应内表面48和50之间的足够的表面区域接触，以提供充分的摩擦力来将移植物延伸部14和15固持在适当位置。改变支腿与延伸部之间的重叠的量可允许实现不同的有效的总移植物长度，进而以比原本所需的尺寸少的不同主体和延伸部尺寸来适应一定范围的解剖大小。对于某些实施例，同侧支腿20和对侧支腿26可具有至少约1cm的轴向长度。对于某些实施例，同侧支腿20和对侧支腿26可具有约2cm到约6cm，更具体来说，约3cm到约5cm的轴向长度。
移植物延伸部14和15可由例如PTFE或ePTFE等柔性移植物材料的内层和外层形成。移植物材料的内层和外层可由多个移植物材料层的管状挤压件、分层包裹物等形成。对于某些实施例，移植物材料的内层或外层可为可渗透的、半渗透的或大体上不可渗透的。对于某些实施例，延伸部14和15的标称长度可为可渗透的，其中一个或一个以上纵向区段(例如，中间的纵向区段)为半渗透或不可渗透的。移植物延伸部14和15的某些实施例可具有整体圆锥形或张开型配置，其具有标称的内腔，所述标称的内腔在移植物延伸部处于放松的扩展状态中时渐细或张开。对于包含分层的材料包裹物的某些实施例，可沿圆周、螺旋地或以任何其它合适的配置来实行所述包裹物。
径向可扩展支架51可插入在延伸部14和15的移植物材料的外层54与内层56之间。安置在移植物材料的外层与内层之间的所述插入的支架可由细长的弹性元件形成，所述弹性元件以多个纵向隔开的匝螺旋地缠绕成开放管状配置。螺旋缠绕的支架51可经配置为自膨式支架或可以由来自例如可扩展气囊等装置的向外径向力致动的无弹性方式而径向扩展。在2000年5月16日申请的戈尔兹等人的标题为“用于增加的柔性的网和支架(Mesh and Stent for Increased Flexibility)”的第6,673,103号美国专利中论述了可用于移植物延伸部14和15的某些管状修补物的实施例，所述美国专利的全文在此以引用的方式并入本文中。
移植物延伸部14和15可任选地包含安置于其相应近端或区段的外表面46和47(图3中所示)上的附接元件，其可用于耦合到安置于主要移植物12的相应同侧支腿20和对侧支腿的内表面上的对应的附接元件。可用于移植物延伸部14和15的外表面46和47以及主要移植物12的支腿20和26的内表面48和50上的附接元件的实施例可包含2005年9月22日公开的斯蒂芬斯等人在2005年3月11日申请的标题为“模块化脉管内移植物(Modular Endovascular Graft)”的第PCT/US2005/008119号国际专利申请案中的附接元件中的任一者，所述国际专利的全文在此以引用的方式并入本文中。具有附接元件的例如系统10等模块化移植物的某些实施例可包含例如移植物主体12的第一移植体区段和例如延伸部14和15的第二移植体区段。第一移植体区段可具有第一壁部分和安置在所述第一壁部分上的第一附接元件，且第二移植体区段可具有安置在第二移植体区段的第二壁部分上的第二附接元件。第二附接元件可经配置以紧固到第一附接元件，其中第一和第二移植体区段的相应流体流动腔密封在一起。对于某些实施例，第一和第二附接元件可在第一和第二移植体区段的重叠部分中紧固在一起。对于某些实施例，第一附接元件可包含多个柔性钩子，且第二附接元件包含彼此邻近的多个柔性环，其中所述柔性钩子经配置以在所述第一和第二附接元件被按压在一起时机械地啮合所述柔性环。对于某些实施例，所述第一附接元件包含多个具有扩大头部的按钮，其在第一壁部分的表面上彼此规则地间隔开，且第二附接元件包含具有多个孔的可扩展网，其经配置以允许在所述网处于圆周受约束的状态中时按钮的扩大头部的进入，且在所述网处于圆周扩展的状态中时俘获按钮的扩大头部。对于某些实施例，第一附接元件包含从第一壁部分的表面径向延伸的多个销，且第二附接元件包含具有多个孔的可扩展网，其经配置以允许在抵靠着第二附接元件按压第一附接元件时所述销的进入。对于某些实施例，第一附接元件可包含含有可固化材料的可膨胀套头，且第二附接元件包含具有倒钩的可扩展部件，其经配置以向外延伸到可膨胀套头和可固化材料中。
处于径向扩展状态中的某些主要移植物的实施例12的主要流体流动腔18的横向尺寸或直径可为约12.0mm到约32.0mm。对于某些实施例，相应的同侧支腿20和对侧支腿26的同侧流体流动腔24和对侧流体流动腔30的横向尺寸或直径可为约5mm到约20mm。对侧支腿26的轴向长度由图1中的箭头57指示。对于某些实施例，支腿20和26的长度可为约2cm到约6cm。移植物延伸部14和15的某些实施例的横向尺寸在处于径向扩展的状态中时可为约5mm到约26mm。移植物延伸部14和15的某些实施例的轴向长度可为约2cm到约15cm，具体来说，约5cm到约10cm。同侧延伸部移植物14和对侧延伸部移植物15的某些实施例在处于扩展状态中时可具有在约10mm到约30mm之间，具体来说，在约15mm与25mm之间的外部横向尺寸或直径。
主要移植物12和同侧移植物延伸部14和15可至少部分由聚四氟乙烯(PTFE)(其可包含膨胀聚四氟乙烯(ePTFE))制成。具体来说，主要移植物12和移植物延伸部14和15可包含任何数目的PTFE和/或ePTFE的层，包含约2层到约15层，在不具有例如高强度支柱、连接器环等的支撑或辅助结构的情况下具有仅针对柔软移植物材料的约0.003英寸到约0.015英寸的未压缩分层厚度。除非另外具体规定，否则本文中所使用的术语“PTFE”包含PTFE、多孔PTFE和ePTFE，其任一者可为不能渗透的、半渗透的或可渗透的。此外，包含本文中所描述的主体和延伸部的移植物组合件和其任何部分可包含所有PTFE、所有ePTFE或其组合。此些移植体区段还可包含适合于移植物应用的任何替代的高强度、柔软的生物相容材料，例如DACRON。卓波托夫等人在2001年12月20日申请的标题为“用于制造脉管内移植物区段的方法和设备(Method and Apparatusfor Manufacturing an Endovascular Graft Section)”的第10/029,557号美国专利申请案(第US 2003/0116260 A1号公开案)、卓波托夫等人在2001年12月20日申请的标题为“脉管内移植物接合部和制造方法(Endovascular Graft Joint and Method of Manufacture)”的第10/029,584号美国专利申请案、卓波托夫等人在2001年12月20日申请的标题为“用于使脉管内移植物材料成形的方法和设备(Method and Apparatus for Shape FormingEndovascular Graft Material)”的第10/029,559号美国专利申请案、卓波托夫等人在2002年12月20日申请的标题为“高级的脉管内移植物(Advanced Endovascular Graft)”的第7,147,660号美国专利、汉弗莱等人在2005年4月13日申请的标题为“PTFE层和制造方法(PTFE Layers and Methods of Manufacturing)”的第11/106,131号美国专利申请案(第US 2006/0233990A1号公开案)，和汉弗莱等人在2005年4月13日申请的标题为“PTFE层和制造方法(PTFE Layers and Methods ofManufacturing)”的第11/106,150号美国专利申请案(第US 2006/0233991号公开案)中可找到对可以任何合适的组合用于本文中所论述的实施例中的任一者的移植物组合件10的移植体区段以及其它组件的各种构造的描述，所述专利和申请案中的每一者的全文以引用的方式并入本文中。
移植物部件12的各个部分的分层结构(包含同侧支腿20和对侧支腿26、延伸部14和15或所有这些)可包含多种配置，其中具有类似但不同特性的分层材料可一起或个别地使用。举例来说，移植物部件12的主体部分的某些实施例可具有约1层到约5层多孔ePTFE材料的分层结构，其具有约5微米到约35微米，更具体来说，约10微米到约25微米的平均节点间距，以及约0.0002英寸到约0.002英寸，更具体来说，约0.0005英寸到约0.0015英寸的厚度。移植物部件12的主体部分还可包含约1层到约5层的半渗透PTFE，其具有第一渗透性以及约0.0002英寸到约0.002英寸，更具体来说，约0.0004英寸到约0.001英寸的厚度。所述主体部分还可包含约1层到约5层的半渗透PTFE材料，其具有不同于第一渗透性的第二渗透性以及约0.0002英寸到约0.002英寸，更具体来说，约0.0004英寸到约0.001英寸的厚度。在这些实施例中可使用以引用的方式并入的美国专利申请案2006/0233990和2006/0233991中所论述的PTFE的半渗透层的任何合适实施例。所述主体部分还可包含约1层到约5层的PTFE，其实质上不具有节点间距且具有非常低的液体渗透性或无液体渗透性，以及约0.0001英寸到约0.0015英寸，更具体来说，约0.0002英寸到约0.001英寸的厚度。
对于不包含附接元件的模块化移植物系统的实施例，移植物延伸部14和15的近端的外表面46和47可分别抵靠着移植物部件12的支腿20和26的流体流动腔的内表面48和50而扩展。此配置可用于将移植物延伸部14和15的流体流动腔44和45密封到支腿20和26的流体流动腔24和30。可扩展部件(例如，可扩展锚部件等)可用于抵靠着支腿20和26的流体流动腔24和30的内表面48和50来扩展移植物延伸部14和15。
可膨胀元件或通道网58安置于主要移植物12上，其可在膨胀材料(未图示)通过主要填充端口60的压力下膨胀，所述主要填充端口60具有安置在其中的与可膨胀通道网58流体连通的腔。膨胀材料可通过安置在主要填充端口60的腔内的单向阀(未图示)而保持在可膨胀通道网58内。可任选地用可硬化材料填充可膨胀通道网58，所述可硬化材料可经配置以在被注射到所述通道中后硬化、固化或另外增加粘度或者变得较具刚性。例如凝胶、液体或其它可固化到更坚固或大体上硬化状态的可流动材料等可硬化膨胀材料可用于依靠安置于通道内的经硬化材料的机械特性而提供对主要移植物12和支腿的机械支撑。可膨胀通道网58也可在处于膨胀状态中时提供对主要移植物12的结构支撑，这是由于通道内增加的内部压力所形成的通道硬度，只要可维持增加的内部压力，即使使用例如盐等不可硬化的膨胀材料也可。硬度或刚性的此类增加可用于多种目的。举例来说，在部署期间，可膨胀通道网的膨胀可促使包含主要流动通道的主要移植体和其支腿符合具有开放的流动腔的大体上圆柱形配置，当试图用递送导液管、导引线等定位并引导对侧或同侧支腿的流动腔时，所述配置可为有用的。还可通过使用在荧光镜成像下提供增强的显像的射线不透性膨胀材料来促进主要移植体和其部分的流动腔的此类定位和引导。
可膨胀通道网58可包含一个或一个以上完全或部分地围绕主要移植物或主要移植物的支腿而安置的圆周通道以及可提供支撑的纵向或螺旋形通道，以及与圆周通道连通的管道，其可用于用膨胀材料填充可膨胀通道网。某些实施例还可采用射线不透性膨胀材料以促进对填充过程和后续的移植物延伸部的啮合的监视。可膨胀通道网58还可包含一个或一个以上呈可膨胀套头(例如，近端可膨胀套头62)形式的一个或一个以上扩大的圆周通道，其可经配置以密封到患者的脉管(例如，患者的腹主动脉)的内表面。近端可膨胀套头62安置在主要移植物12的近端部分上，位于近端锚部件32的远端，且具有从主要移植物12的标称外表面径向延伸的外表面。可膨胀套头62可经配置以径向扩展超过主要移植物12的标称外表面，且在可膨胀套头62以膨胀材料膨胀到扩展状态时密封主体腔的内表面。近端锚部件32和近端可膨胀套头62的轴向分离允许主要锚定机构与密封功能的至少部分的空间分离，其可允许移植物受到约束或以其它方式被压缩到较小的外部型面以用于从递送导液管进行部署。可膨胀套头62的内部空腔与剩余的可膨胀通道网的内部空腔流体连通，且可具有约0.040英寸到约0.250英寸的横向尺寸或内径。
主要移植物部件12的某些实施例可包含围绕每一支腿20和26而安置的约1到约8个圆周可膨胀通道以及围绕主要移植物部件12的主体部分而安置的约1到约8个圆周通道。主要移植体部件12的某些实施例可包含约1到约4个纵向或轴向可膨胀通道，其可用以连接圆周可膨胀通道。圆周通道的某些实施例可延伸所述圆周通道安置于其上的移植物区段的整个圆周，或其可仅部分地在所述圆周通道安置于其上的移植物区段周围延伸。对于图1中所示的主要移植物部件的实施例12，可膨胀通道网58包含邻近于主要移植物部件12的主体部分的近端而安置的可膨胀套头62以及仅安置在可膨胀套头62的远端的圆周通道。主要移植物部件12的每一支腿20和26包含轴向串联的3个完整的圆周可膨胀通道。每一支腿20和26还具有安置在完整圆周可膨胀通道的近端的两个部分圆周可膨胀通道。纵向或轴向通道大体上沿着主要移植物部件12的同侧而延伸，以与填充端口60和同侧支腿20的圆周通道以及主体部分的近端处的圆周通道和可膨胀套头62流体连通。另一轴向通道沿着主要移植物部件12的整个对侧延伸，以与套头62、主体部分的近端处的圆周通道和对侧支腿26的圆周通道流体连通。
本文中所论述的移植物部件的实施例的某些可膨胀通道可沿圆周并轴向安置，例如图1的实施例中所示。或者，此些可膨胀通道可以螺线形、螺旋形或其它配置安置。在卡里等人在2003年3月6日申请的标题为“抗纽结脉管内移植物(Kink ResistantEndovascular Graft)”的共同拥有的待决的第10/384,103号美国专利申请案中进一步描述了适合于本发明的实施例的通道配置的实例，所述申请案的全文以引用的方式并入本文中。在本文中描述为圆周的所有可膨胀通道的实施例可替代地采取上述替代性配置中的任一者。卓波托夫等人在2005年4月1日申请的标题为“混合的模块化脉管内移植物(Hybrid Modular Endovascular Graft)”的待决的第11/097,718号美国专利申请案(2006/0224232)中论述了其它模块化移植物的实施例，所述申请案的全文在此以引用的方式并入本文中。
可在部署移植物期间用任何合适的膨胀材料来填充可膨胀套头62和其它可膨胀通道网58。如上文所论述，膨胀材料可用于从可膨胀套头62或可膨胀通道网58内提供向外压力或刚性结构。可使用生物相容性气体、液体、凝胶等，包含可固化聚合材料或凝胶，例如胡贝尔等人在2000年2月1日申请的标题为“通过与共轭不饱和基团的亲核加成反应而形成的生物材料(Biomaterials Formed by Nucleophilic Addition Reaction toConjugated Unsaturated Groups)”的待决的第09/496,231号美国专利申请案和胡贝尔等人在2000年6月2日申请的标题为“用于有药效的化合物的受控递送的共轭加成反应(Conjugate Addition Reactions for Controlled Delivery of Pharmaceutically ActiveCompounds)”的待决的第09/586,937号美国专利申请案中描述，且在卓波托夫等人在2002年12月20日申请的标题为“高级脉管内移植物(Advanced Endovascular Graft)”的共同拥有的待决的第10/327,711号美国专利申请案中进一步论述的聚合生物材料，上述申请案中的每一者的全文以引用的方式并入本文中。某些实施例可使用由缩水甘油醚和胺材料形成的膨胀材料，如阿斯卡里和厄力在2005年4月1日申请的且标题为“不可降解、低膨胀、水溶性的射线不透性水凝胶聚合物(Non-Degradable，Low-Swelling，Water Soluble Radiopaque Hydrogel Polymer)”的第11/097,467号美国专利申请案(第2006/0222596号公开案)中所论述。某些膨胀材料的实施例可包含原位形成的水凝胶聚合物，其具有第一量的二胺和第二量的多缩水甘油醚，其中每一量均存在于哺乳动物或医疗装置中，例如可膨胀移植物，其以一量定位在哺乳动物中以产生原位形成的水凝胶聚合物，所述水凝胶聚合物是生物相容的且在混合后具有约10秒到约30分钟的固化时间，且其中所述水凝胶聚合物的体积在固化和水合之后膨胀小于30％。膨胀材料的某些实施例可包含射线不透性材料，例如碘化钠、碘化钾、硫酸钡，威视派克320(Visipaque320)、3，5二乙酸胺基-2，4、欧乃派克350(Omnipaque 350)、海赛显(Hexabrix)等。对于某些膨胀材料的实施例，多缩水甘油醚可选自以下各物：三羟甲基丙烷三缩水甘油醚、山梨醇多缩水甘油醚、聚甘油多缩水甘油醚、季戊四醇多缩水甘油醚、双甘油多缩水甘油醚、丙三醇多缩水甘油醚、三羟甲基丙烷多缩水甘油醚、聚乙二醇二缩水甘油醚、间苯二酚二缩水甘油醚、p-羟基苯甲酸的缩水甘油酯醚、新戊二醇二缩水甘油醚、1，6-己二醇二缩水甘油醚、双酚A(PO)2二缩水甘油醚、对苯二酚二缩水甘油醚、双酚S二缩水甘油醚、对苯二酸二缩水甘油酯，和其混合物。对于某些膨胀材料的实施例，二胺可选自具有胺基或烷基胺基末端的(聚)烷撑二醇，其选自由以下各物组成的群组：聚乙二醇(400)二胺、二(3-胺基丙基)二甘醇r、聚氧基丙二胺、聚醚胺、聚氧基乙二胺、三乙二醇二胺，和其混合物。对于某些实施例，二胺可为亲水的，且多缩水甘油醚在固化之前可为亲水的。对于某些实施例，二胺可为亲水的，且多缩水甘油醚在固化之前为疏水的。对于某些实施例，二胺可为疏水的，且多缩水甘油醚在固化之前可为亲水的。
可用于某些实施例的其它膨胀材料包含聚环氧乙烷材料和二丙烯酸新戊二醇酯材料，其在第6,610,035号和第6,176,849号美国专利中有论述，所述专利的全文以引用的方式并入本文中。上文所论述的第7,147,660号美国专利还包含可用于本文中所论述的实施例的膨胀材料的实施例。
参看图1A，近端锚部件32可安置于主要移植物12的近端上且紧固到连接器环68，所述连接器环68至少部分安置于主要移植物12的近端部分上。对于某些实施例，连接器环68可嵌入在主要移植物12的近端区段的移植物材料中，且还可由邻近于连接器环68的PTFE层的一个或一个以上翼片元件紧固。邻近层的翼片可折叠在连接器环上且紧固到连接器环68、邻近的PTFE材料层，或紧固到两者。例如FEP等粘附材料也可用于将连接器环68紧固到主要移植体12。近端连接器环68具有连接器元件70，其从连接器环68在近端延伸超过主要移植物12的移植物材料的近端。连接器元件可用于耦合到或以其它方式紧固到近端锚部件32的从近端锚部件32的远端支架32B的远端侧在远端延伸的相配的连接器元件。近端锚部件32可具有大体上圆柱形或环状配置，其中锚部件的近端支架32A和远端支架32B的细长元件以圆柱体的蜿蜒或正弦波状图案预成形。近端锚部件可具有允许锚定在多种体腔配置中的横向尺寸或直径。可适合用于患者的腹主动脉中的近端锚部件32的某些实施例可具有约20mm到约40mm的横向尺寸或直径。形成近端锚部件32的细长元件可具有约0.005英寸到约0.040英寸的径向厚度。形成近端锚部件32的细长元件的宽度可为约0.01英寸到约0.2英寸。上文所论述的第7,147,660号美国专利还包含可用于本文中所论述的实施例的锚部件的实施例。
近端锚部件32用如图5A和图5B中所示的带凸缘的连接器元件70而紧固到连接器环68。带凸缘的连接器元件70可与线圈70A一起紧固，所述线圈70A经配置以配合在连接器元件70的带凸缘的部分的耳部之间，其具有大于连接器元件70的中间部分的横向尺寸。带凸缘的部分提供用于线圈70A的一对相对的表面以抵靠两个邻近的连接器元件70而安置且将其机械地俘获在一起。用于耦合带凸缘的元件的线圈70A可具有约0.005英寸到约0.050英寸，更具体来说，约0.010英寸到约0.030英寸的内部横向尺寸，且具有其直径的约2倍到约15倍，更具体来说，其直径的约4倍到约8倍的轴向长度。
再次参看图1A，近端支架32A用安置于两个支架(图6A到图6D中更详细地展示)的邻近冠之间的支柱71耦合到近端锚部件32的远端支架32B。所述支柱可经配置以使得支架32A和32B和支柱的材料的横截面积从远端支架的近端部分到近端支架的远端部分大体上保持恒定。对于某些实施例，支柱71的区域中的材料的横截面积大于邻近于支柱71的近端支架32B或远端支架32A的横截面积。此配置可用于避免近端支架32A与远端支架32B之间的接合点处的应力和张力集中。
在连接器环68与远端支架32B的远端之间的接合点处可使用类似的结构配置。对于此接合点，安置于连接器环68与连接器元件70之间的支柱72(如图5A中所示)可具有与邻近于连接器元件70的连接器环68的横截面积大体上相同或比其大的横截面积。另外，安置于远端支架32B的远端与远端支架32B的连接器元件70之间的支柱73可具有与邻近于支柱73的远端支架32B的横截面积大体上相同或比其大的横截面积。此配置可用于避免连接器环68与近端锚部件32的远端支架32B之间的接合点中的应力和张力集中。
近端锚部件32和其组件可具有多种配置，其可收缩到用于经皮或其它类型的递送的小横向尺寸或直径，且可扩展以啮合患者的脉管系统的内表面，以提供对脉管系统的锚定且防止或抵制锚部件或附接到其的移植物区段的轴向移动。锚部件的实施例32可经配置为具有波动图案的自膨式锚部件，且可由不锈钢、镍钛合金或任何其它合适的材料制成。锚部件32可经配置为可从径向压缩的状态在向外径向方向上扩展或自膨的气囊。可通过从选定材料(例如，上文所论述的材料)的单个管状零件切割这些元件的配置而形成远端锚部件32和连接器环68。锚部件32的近端支架32A还可任选地包含倒钩33，其从锚部件向外成角度且经配置以啮合脉管壁的组织并在部署后防止锚部件的轴向移动。近端锚部件32和其近端支架32A和远端支架32B可具有与卓波托夫等人在2002年12月20日申请的第10/327,711号美国专利申请案(US 2003/0125797 A1)中所描述的支架的特征、尺寸或材料相同或类似的特征、尺寸或材料，所述申请案的全文在此以引用的方式并入本文中。锚部件32的远端支架32B还可以与上文并入的申请案中所描述的方式相同或类似的方式紧固到连接器环68。
可为有用的是主要移植物12的某些实施例具有标称轴向长度，其经配置以允许在广泛多种脉管拓扑中与一个或一个以上移植物延伸部14和15的增补一起使用主要移植物12。模块化移植物的实施例10通常经选择以便具有对患者的脉管系统的适当配合。对于某些移植物的指示，有必要生产大量的大小变化的移植物系统，或移植物组合件10的组件，以便适应每一患者的脉管系统的大小和配置变化，以便实现移植物组合件10在患者的脉管系统内的可接受的配合。对于脉管内移植物组合件10的制造商和必须维持装置的全面库存的医院来说，这可为非常昂贵和耗时的。另外，这可能需要医院手术室或导液管实验室中的不方便的量的货架空间。对于某些实施例，主要移植物部件12可具有一轴向长度，其经选择以允许锚定邻近于从患者的主动脉延伸的肾动脉的近端锚部件32，其中分叉的部分的支腿在具有不同体格和脉管配置的患者的较大横截面中保持不接触髂动脉。以此方式，可避免对定制用于特定患者或患者群组的移植物组合件10的需要。
对于某些实施例，主要移植物部件12的轴向长度，且特定来说，近端锚部件32与同侧支腿20和对侧支腿26的远端之间的轴向距离或间隔可经选择以延伸越过腹主动脉瘤，而不延伸到选定患者的髂动脉中。选定的患者可为具有恰在肾动脉的远端的主动脉中的密封点与髂动脉中的最远端可行锚定和密封点之间的最长轴向间隔的患者群组中的成员。在特定患者群组的某些实施例中，主要移植物部件12的近端与同侧支腿20和对侧支腿26轴向分离约5cm到约10cm，更具体来说，约6cm到约8cm的长度，如图1中的箭头74所指示。
对于设计主要移植物部件的实施例12的大小的某些实施例，近端锚部件32与所部署的移植物延伸部14和15的远端的间隔经选择以使得所述间隔恰好足够长以跨越肾动脉与患者的髂动脉或主动脉中的最近端的锚定和密封点之间的间隔。可从选定患者群组中的在此选定患者群组中具有最长的此间隔的患者确定此距离。另外，对于这些实施例，此间隔必须短于肾动脉与腹下动脉或主动脉之间的间隔。可从选定患者群组中的在此选定患者群组中具有最短的此间隔的患者确定所述距离。以此方式，有可能用具有共同的主要移植体长度的主要移植物部件12的实施例来治疗选定患者群组中的所有成员。可将此些实施例锚定到患者的肾动脉的远端的患者的主动脉，且在患者的髂动脉中在远端锚定，而不阻塞肾动脉或腹下动脉。此类模块化移植物系统的实施例10可具有约10cm到约22cm，具体来说，约11cm到约20cm的总长度(包含主要移植物部件12和所部署的移植物延伸部14和15)。
主要移植物12的仔细大小设计和配置允许在通过一个或一个以上移植物延伸部14和15来增补时单个主要移植物12的实施例或设计的使用可适于较广范围的患者。更具体来说，具有约5cm到约8cm的轴向长度的主要移植物12可适当地部署在较大百分比的潜在患者中。一旦经部署，可随后用移植物延伸部14和15的部署将主要移植物12的同侧支腿20和对侧支腿26的流体流动腔24和30密封到患者的髂动脉。虽然移植物组合件10包含使用附接元件将移植物延伸部14和15紧固到主要移植物12的同侧支腿和对侧支腿的选项，但这在大多数情况下可为非必需的，且可通过在移植物延伸部14和15上使用标准的可扩展部件而不是附接元件来实现对移植物延伸部14和15的足够密封和机械固定。
治疗患者的一种方法的某些实施例包含提供含有径向受约束的分叉的主要移植物部件的递送导液管。所述主要移植物部件可由柔软的移植物材料形成，其在其中具有主要流体流动腔，且其具有：同侧支腿，其具有与所述主要流体流动腔连通的同侧流体流动腔；以及对侧支腿，其具有与所述主要流体流动腔连通的对侧流体流动腔。所述主要移植物部件还可包含可膨胀通道网，其安置于所述主要移植物部件上。可膨胀通道网的可膨胀通道可安置于主要移植物部件的任何部分上，包含主要移植物部件的同侧和对侧支腿。所述主要移植物部件还可包含近端锚部件，其安置在主要移植物部件的近端处且紧固到所述主要移植物部件。所述近端锚部件可具有紧固到自膨式远端支架部分的自膨式近端支架部分。
所述递送导液管可轴向定位在患者的脉管系统内，使得所述递送导液管内的主要移植物部件与患者的主动脉的脉管缺陷以同延方式安置。一旦已实现此定位，所述近端锚部件可经部署以便啮合患者的脉管系统的内表面，且将近端锚部件锚定到患者的主动脉。其后，主要移植物部件的可膨胀通道网可以膨胀材料膨胀，以便提供更具机械刚性的结构。对于某些实施例，可使用可固化或可硬化的填充物材料，其可在可膨胀通道网的膨胀之后固化，以便提供额外的机械刚性以及防止填充物材料的泄漏。某些实施例还可采用射线不透性膨胀材料以促进对填充过程和后续的移植物延伸部的啮合的监视。
含有径向受约束的自膨式对侧移植物延伸部的第二递送导液管可随后轴向定位在主要移植物部件的对侧支腿中，其中对侧移植物延伸部的近端部分与主要移植物部件的对侧支腿的内部流体流动腔轴向重叠，且对侧移植物延伸部的远端部分与患者的对侧髂动脉的一部分轴向重叠。可通过经皮进入或用递送鞘等从患者的对侧股动脉进行股动脉剖开术而实现对主要移植物部分的对侧支腿的进入。一旦适当地定位，便可通过释放第二递送导液管的径向约束来部署自膨式对侧移植物延伸部。当对侧移植物延伸部在向外径向方位上自膨时，可在对侧移植物延伸部的内部流体流动腔、对侧支腿的流体流动腔与对侧髂动脉的流体流动腔之间形成密封。
含有径向受约束的自膨式同侧移植物延伸部的第三递送导液管随后可轴向定位在主要移植物部件的同侧支腿中，其中同侧移植物延伸部的近端部分与主要移植物部件的同侧支腿的内部流体流动腔轴向重叠，且同侧移植物延伸部的远端部分与患者的同侧髂动脉的一部分轴向重叠。随后可通过释放径向约束来部署自膨式同侧移植物延伸部，以便在同侧移植物延伸部的内部流体流动腔、同侧支腿的流体流动腔与同侧髂动脉的流体流动腔之间形成密封。
对于某些治疗患者的脉管系统的方法实施例，可使用模块化移植物组合件，例如上文所论述的模块化移植物组合件的实施例10。图7到图14说明模块化移植物组合件的一实施例的部署序列的一实施例。对于脉管内方法，可通过执行动脉切开术或向下切到患者的股动脉或通过其它普通技术(例如，经皮Seldinger技术)而实现对患者的脉管系统的进入。对于此些技术，通过使用扩张器和引导线组合件，可将递送鞘(未图示)放置成与患者的脉管(例如，股动脉)的内部连通。一旦递送鞘经定位，便可通过递送鞘实现对患者的脉管系统的进入，可任选地通过止血阀或其它合适的机构来密封所述递送鞘。对于某些手术，可能有必要经由递送鞘或其它合适的构件在朝向患者的主动脉向上游引导递送鞘的情况下来获得对患者的两个股动脉的进入。在某些应用中，可不需要递送鞘，且可通过动脉切开术或经皮穿刺将递送导液管75直接插入到患者的进入脉管中。
一旦递送鞘已被适当定位，随后可通过递送鞘使含有模块化移植物组合件的组件(例如，移植物部件12)的递送导液管75在引导线76上前进，且进入患者的脉管系统中。在一个特定的部署方法实施例中，主要移植物部件12通常在同侧髂动脉的近端方向上，经由导液管或具有低型面和侧向柔性以易于递送通过患者的脉管系统的类似装置，以受约束的状态在递送导液管75内前进通过患者的脉管，到达所需的部署部位(例如，腹主动脉)。在所需的部署部位处，主要移植物12的近端锚部件32从受约束的状态释放，且允许近端锚部件32扩展并将主要移植物12的一部分紧固到患者的脉管系统。可通过任何合适的装置和方法实行对模块化移植物组合件10的部署，包含卓波托夫等人在2001年7月27日申请的标题为“用于分叉的脉管内移植物的递送系统和方法(Delivery Systems and Methods for Bifurcated Endovascular Graft)”的第6,761,733号美国专利以及卓波托夫等人在2005年8月15日申请的标题为“用于分叉的移植物的递送系统和方法(Delivery System and Method for Bifurcated Graft)”的第11/205,793号美国专利申请案中所揭示的技术和随附设备，所述专利的全文以引用的方式并入本文中。
递送导液管75可在血液流的上游在近端前进(如箭头77所指示)进入患者的脉管系统(包含髂动脉78和主动脉79)中(如图7中所示)。图中所示的患者的脉管系统的其它脉管包含肾动脉80和腹下动脉81。递送导液管75可前进进入患者的主动脉79中，直到主要移植物12大体上安置成邻近于主动脉瘤82或待治疗的其它脉管缺陷为止。一旦递送导液管75经如此定位，便可在远端收回递送导液管75的外鞘83，以便暴露已被压缩和压紧以配合在递送导液管75的外鞘83的内腔内的主要移植物12，如图8所示。除了在安置于递送导液管75的外鞘83的内腔内时被径向压缩外，近端支架32A和远端支架32B已被相应的高强度柔性带86径向约束，以便维持较小的型面，且避免在起始支架32A和32B的部署之前支架32A和32B与身体腔啮合。可通过延伸穿过带86的成环端的一个或一个以上线或细长杆88来紧固带86的末端。一旦已收回递送导液管75的外鞘83，递送导液管75和移植物组合件的实施例10便可小心地定位在轴向方向上，使得远端支架32B大体上与肾动脉80齐平安置，其中近端锚部件32和近端密封套头62定位在动脉瘤82的近端。近端锚部件32随后经部署且锚定到患者的主动脉79。
通过收回耦合约束远端支架32B的带88的末端的线或杆86，近端锚部件32的部署可开始于远端支架32B的部署。甚至在部署近端锚部件32的近端支架32B之后，也通常可实行额外的轴向定位。这仍可在许多情形中实行，因为对于某些实施例，远端锚32的远端支架部分32B不包含组织啮合倒钩33，且在部署近端支架32A之前将仅提供对患者的脉管79的内腔的部分向外径向接触或摩擦力。一旦已释放约束远端支架32B的带86，远端支架32B便在向外径向方向上自膨，直到近端支架32B的外表面接触并啮合患者的脉管79的内表面90为止，如图9中所示。
在已部署远端支架32B之后，随后可通过收回耦合约束近端支架32B的带86的末端的线88而部署近端支架32A。在近端支架32A在向外径向方向上自膨时，近端支架32A的外表面最终接触患者的主动脉79的内表面90。对于在近端支架32A上包含组织啮合倒钩33的实施例，还可在向外径向方向上定向和推动倒钩，以便接触并啮合患者的脉管79的内表面组织90，其进一步将近端锚部件32紧固到患者的脉管79，如图10中所示。
一旦已将近端锚部件32紧固到患者的脉管79的内表面90，随后便可用通过递送导液管75的膨胀管91注射的膨胀材料来通过膨胀端口60填充近端可膨胀套头62，其可用以将可膨胀套头62的外表面密封到脉管79的内表面83。还同时用经加压的膨胀材料来填充剩余的可膨胀通道网58，其向移植物12提供更具刚性的框架状结构，如图11中所示。对于某些实施例，膨胀材料可为可固化或可硬化的材料，其可在将可膨胀通道网填充到所需的材料水平或网内的压力时经固化或硬化。某些实施例还可采用射线不透性膨胀材料以促进对填充过程和后续的移植物延伸部的啮合的监视。可通过本文中所论述的合适的方法中的任一者来使材料固化，包含时间逝去、热的施加、电磁能的施加、超声波能量的施加、化学物的添加或混合等。
可通过将合适的膨胀材料注射到主要填充端口60而使可膨胀通道网58部分或完全膨胀，以向可膨胀通道网58和主要移植物12提供刚性。另外，在可膨胀套头62与腹主动脉82的内表面之间产生密封。虽然需要在部署过程的此阶段处使主要移植物12的可膨胀通道网58部分或完全膨胀，但在必要时可任选地在稍后的阶段完成此膨胀步骤。
一旦移植物部件12经锚定且其可膨胀通道58已被填充和扩展，含有对侧移植物延伸部15的第二递送导液管92便可直接或通过如上文所论述的递送鞘进入对侧股动脉。如图12中所示，第二递送导液管可在近端前进，直到径向受压缩的对侧移植物延伸部15处于与移植物部件12的对侧支腿26重叠的轴向位置中为止。移植物延伸部15与对侧支腿26的所需重叠的量可变化，其取决于多种因素，包含脉管拓扑、脉管疾病程度、患者状态等。然而，对于某些实施例，对侧移植物延伸部15与对侧支腿26之间的轴向重叠的量可为约1cm到约5cm，更具体来说，约2cm到约4cm。此重叠的定位还可提供移植物延伸部15的流体流动腔45与对侧支腿26的流体流动腔之间的纵向重叠。
一旦经适当定位，第二递送导液管92的可径向约束对侧移植物延伸部15的外鞘94便可在远端撤回，同时移植物延伸部15保持大体上轴向固定。第二递送导液管92的外鞘94的此轴向收回部署对侧移植物延伸部15，以便允许移植物延伸部15径向自膨且啮合对侧支腿26的内腔30以及在对侧支腿26的近端的对侧髂动脉的内表面，如图13中所示。移植物延伸部15可经如此部署以在对侧支腿26的内腔30被密封到移植物延伸部15的内腔45的情况下延伸主要移植物12的对侧支腿20。一旦对侧移植物延伸部15已被部署，便可从患者的脉管系统撤回第二递送导液管92。
对于某些实施例，直到已用膨胀材料填充可膨胀通道网58且所述膨胀材料已固化或硬化为止，细长系链96可用于轴向约束移植物12且防止移植物12与递送导液管75的轴向分离。在递送导液管75的膨胀管91仅通过重叠的滑动配合或过盈配合而紧固到移植物部件12的可膨胀通道网58的填充端口60的实施例中，此轴向约束可较重要。对于某些实施例，膨胀管91可与移植物12的填充管60重叠约5mm到约25mm，且更具体来说，约10mm到约15mm。系链96环绕通过移植物部件12的同侧支腿20和对侧支腿26的流动腔24和30，且紧固到递送导液管75的近端适配器(未图示)上的柄部。系链96经配置以具有足够短的长度，以机械地约束主要移植物部件12相对于递送导液管75的远端轴向移动，以便防止膨胀管91从主要移植物部件12的膨胀或填充端口60解耦。一旦膨胀材料已被完全注射到可膨胀通道网58中且经固化或硬化，便可释放系链96且将其移除以允许递送导液管75的远端收回，如图14中所示。
一旦已大体上从移植物主要部件12和患者的脉管系统释放系链96且收回和解耦递送导液管75，便可使含有同侧移植物延伸部14的第三递送导液管(未图示)直接或通过上文所论述的同侧递送鞘而前进进入患者的脉管系统中。第三递送导液管可具有与第二递送导液管92的特征、尺寸和材料相同的特征、尺寸和材料。第三递送导液管可在近端前进通过患者的股动脉且进入同侧髂动脉78中，直到径向受压缩的同侧移植物延伸部14处于与移植物部件12的同侧支腿20重叠的轴向位置中为止。尽管未图示，但第三递送导液管的此前进可以与上文所论述的用于部署对侧移植物延伸部15的对第二递送导液管92的部署相同或类似的方式实行。移植物延伸部14与同侧支腿20的所需重叠的量可再一次变化，其取决于多种因素，包含脉管拓扑、脉管疾病程度、患者状态等。然而，对于某些实施例，同侧移植物延伸部14与同侧支腿20之间的轴向重叠的量可为约1cm到约5cm，更具体来说，约2cm到约4cm。
此重叠的定位还可提供移植物延伸部14的流体流动腔44与同侧支腿20的流体流动腔24之间的纵向重叠。一旦经适当定位，第三递送导液管的可经配置以径向约束同侧移植物延伸部14的外鞘便可在远端撤回，同时移植物延伸部14保持大体上轴向固定。第三递送导液管的外鞘的此轴向收回部署同侧移植物延伸部14，以便允许移植物延伸部14径向自膨且啮合同侧支腿20的内腔以及在同侧支腿20的近端的同侧髂动脉的内表面，如图14中所示。延伸部14可经如此部署以在同侧支腿20的内腔被密封到移植物延伸部14的内腔44的情况下延伸主要移植物12的同侧支腿20。
对于某些部署的实施例，患者的腹下动脉可用于用作定位参考点以确保腹下动脉不被部署阻塞。在此部署后，移植物延伸部14或15的远端可部署在移植物12的同侧或对侧支腿的长度内的任何地方。而且，虽然仅展示一个移植物延伸部部署在移植物组合件10的同侧和对侧上，但额外的移植物延伸部14和15可部署在已部署的移植物延伸部14和15内，以便实现同侧支腿20和对侧支腿26的所需长度延伸。对于某些实施例，约1个到约5个移植物延伸部14或15可部署在移植物组合件10的同侧或对侧上。连续的移植物延伸部14和15可部署在彼此内，以便使连续的移植物延伸部的流体流动腔纵向重叠。
主要移植物区段12的移植物延伸部14和15(其在某些实施例中可为可互换的)或任何其它合适的延伸装置或部分可包含多种合适的配置。对于某些实施例，移植物延伸部14和15可包含PTFE覆盖的螺旋形镍钛合金支架51(如上文所论述)，其中PTFE层具有多种特性。关于支架51，其可由以多个纵向隔开的匝螺旋地缠绕的细长弹性元件形成。某些支架的实施例51的配置可为大体上螺旋形，其中蜿蜒或其它规则隔开的波动横越细长支架元件的螺旋形路径，如图15中更详细地展示。如所示，支架元件的末端可紧固到支架51的邻近的环部分，以避免将元件末端暴露到PTFE移植物材料或可能的患者组织。图15中所示的支架51的支架元件是从延伸部14的一端到其另一端的连续元件。可通过任何合适的手段(例如，粘附结合、例如激光焊接、软焊等的焊接)将细长元件的末端紧固到邻近的环部件。对于某些实施例，支架元件可具有约0.005英寸到约0.015英寸的横向尺寸或直径。
对于移植物延伸部14的某些实施例，可组合使用具有不同特性的材料层以实现所需的临床表现。举例来说，覆盖支架51的某些PTFE层可为可渗透的、半渗透的或大体上不可渗透的，其取决于所需的性能和材料特性。图16说明图15的延伸部14的一实施例的横向横截面图，其展示PTFE的外层54和PTFE的内层56。所述层54和56可通过多种方法施加且具有多种配置。举例来说，某些层的实施例可包含经由模芯或子组合件轴向施加的挤压管状结构。可通过沿圆周包裹若干层或以重叠的螺旋形图案包裹若干带或条带而应用某些层的实施例54和56。对于某些实施例，外层54可由半渗透或大体上不可渗透的PTFE层100制成或包含所述PTFE层100，且内层56可由PTFE的可渗透层102制成或包含所述PTFE的可渗透层102。
可通过经由模芯(例如，圆柱形模芯(未图示))使材料层100和102与支架51一起形成来制成延伸部14。一旦延伸部14的最内层102已包裹在成形的模芯周围，便可将例如螺旋形支架51等螺旋形镍钛合金支架放置在最内层的PTFE层56和下伏的模芯上。不具有传统的节点原纤维微结构的低渗透性PTFE膜或大体上不具有渗透性的PTFE膜的一个或一个以上额外层100可包裹或以其它方式添加在支架51的外部上。随后可用柔性管覆盖模芯，使得膜和支架在压力下被夹住且经烧结，以便升高PTFE材料的温度以经受熔体转变，以便锁定其几何形状和强度。从装置上移除柔性管(未展示制造辅助)，且从模芯中移除所得的延伸部。
图16说明已与模芯共形的延伸部实施例14的分层结构，其中支架上的PTFE材料层与支架元件共形以便形成粘着结构。另外，对于某些实施例，在施加覆盖支架的PTFE层之前，或在任何其它合适时间或位置处，可邻近于支架施加例如FEP等粘合剂，以便促进支架元件与邻近于支架51的PTFE材料100和102之间的结合。对于图16中所示的延伸部14的实施例，延伸部可具有与上文关于图1到图6中所示的延伸部实施例14而论述的特征、尺寸和材料相同的特征、尺寸和材料。对于某些实施例，可渗透PTFE材料102可包含带单轴节点原纤维结构的具有单轴扩展的ePTFE材料。对于某些实施例，也可使用具有多轴节点原纤维定向的PTFE材料。对于某些实施例，可渗透材料102可包含约1层到约5层的材料或更多层的材料，且具有约10微米到约30微米的节点间距离。对于某些实施例，可渗透材料102可具有约0.00005英寸到约0.005英寸的厚度。
对于某些实施例，低渗透性非扩展PTFE材料100可具有非典型的节点原纤维微结构，其实质上不具有节点间距且具有非常低的或不具有液体渗透性。延伸部14和15可包含约1层到约5层的半渗透或大体上不可渗透的PTFE材料，其具有约0.0001英寸到约0.005英寸，更具体来说，约0.0004英寸到约0.001英寸的厚度。在上文所描述的第2006/0233990号和第2006/0233991号美国专利申请公开案中描述了此些材料的实例，所述公开案的全文以引用的方式并入本文中。
对于某些实施例，可通过提供PTFE层且将例如isopar润滑材料等拉伸剂施加到PTFE层的至少一部分，且在用拉伸剂润湿所述层的同时拉伸PTFE层，而制成具有低渗透性或大体上无渗透性的PTFE材料100。对于某些实施例，可在拉伸的同时用拉伸剂浸透PTFE层。对于某些实施例，可通过约2∶1到约20∶1的比率来拉伸PTFE层。对于某些实施例，可在横越机器扩展方向的方向上实行对PTFE层的拉伸。对于某些实施例，在约80℉到约130℉的温度下，或在恰好高于PTFE层材料的玻璃化转变温度的温度下实行PTFE层的润湿拉伸。对于某些实施例，通过将经化合的PTFE树脂挤压通过挤压机以形成PTFE条带压出型材，而制成所提供的PTFE层。此类PTFE材料100可具有大体上低的多孔度、低渗透性、无可辨识的节点和原纤维结构，以及约0.00005英寸到约0.005英寸的厚度。某些此类PTFE材料还可具有带多个互连的高密度区的闭合单元微结构，其中在高密度区之间不具有可辨识的节点和原纤维结构。某些此类PTFE材料可具有低的或不具有流体渗透性。
图17A到图17E以横向横截面说明若干有用的延伸部配置14的示意性表示，所述延伸部配置14可具有与上文图16中所示的实施例以及图4中所示的实施例的材料、尺寸和特征相比相同或类似的材料、尺寸和特征。如图16中所示，所展示的横截面不指示PTFE层与支架结构的共形性质，而是旨在展示对于延伸部14和15的特定实施例和任何其它合适的延伸部的实施例，PTFE层相对于支架51的数目、位置和类型，然而，可通过上文所论述的方法在这些实施例中产生图16的共形配置。图17A到图17E的实施例是针对于延伸部14，其具有低渗透性或大体上无渗透性且具有良好的结构完整性，尤其在PTFE层材料汇合支架51的区域中。
图17A说明具有可渗透PTFE材料的一个或一个以上内层102以及安置于所述内层与支架51之间的半渗透或大体上不可渗透PTFE材料的一个或一个以上层100的延伸部配置14。半渗透或大体上不可渗透PTFE材料的一个或一个以上层安置在支架51外部。PTFE材料层中的每一者已沿圆周或螺旋地围绕自身包裹以形成具有重叠的末端或边缘的连续管状结构。图17B说明与图17A的延伸部配置大体上相同的延伸部配置，除了PTFE材料的最内层102不沿从延伸部14的一端延伸到延伸部14的另一端的纵向或螺旋线连接，如由图17B中所示的最内层中的间隙所指示。如此，图17B的延伸部实施例14的最内层形成大体上管状结构，但其不是闭合或完整的管状结构。对于某些实施例，图17A和图17B中的由可渗透材料102形成的管状结构可具有大体上沿着延伸部14的纵向轴线定向的材料的节点原纤维方向。
图17C说明与图17A的延伸部配置也大体上相同的延伸部配置14，除了可渗透PTFE材料的最内层经配置为连续的挤压管状结构，其与图17A和图17B中的实施例所指示的包裹结构相对。支架51的任一侧上的半渗透或大体上不可渗透材料层100展示为带重叠末端以形成连续且闭合的管状结构的螺旋形或沿圆周包裹的结构。图17D说明在支架51的内侧上具有可渗透材料的挤压管状最内层102以及在支架51的相对侧上具有挤压管状可渗透PTFE材料的类似层102的延伸部配置14。挤压管状可渗透材料层102在支架51的任一侧上形成相应的闭合且连续的管状结构。半渗透或大体上不可渗透材料层100安置于可渗透材料的外层102上，且沿圆周或螺旋地包裹，其具有重叠末端以形成闭合的管状结构。
图17E说明具有一内部管状结构的延伸部配置的实施例14，所述内部管状结构由安置成邻近于可渗透材料的层或邻近层102的半渗透或大体上不可渗透材料的层或邻近层100形成，所述层100和层102已被包裹在一起以形成安置于支架51内的连续且闭合的管状结构。半渗透或大体上不可渗透材料层100的圆周末端或边缘沿圆周延伸超过可渗透材料102的圆周末端或边缘。如此，内部包裹层(其可螺旋地或沿圆周包裹)经布置以使得可渗透材料102永不接触到自身或支架51。
关于上文详细描述，其中所使用的相同参考标号指代可具有相同或类似尺寸、材料和配置的相同元件。虽然已说明且描述了实施例的特定形式，但将了解，在不脱离本发明的实施例的精神和范围的情况下，可做出各种修改。因此，不希望本发明受到前述详细描述限制。

Claims (38)

1.一种模块化脉管内移植物组合件，其包括：
分叉的主要移植物部件，其由柔软的移植物材料形成，所述分叉的主要移植物部件具有：在其中的主要流体流动腔；同侧支腿，其具有与所述主要流体流动腔连通的同侧流体流动腔；对侧支腿，其具有与所述主要流体流动腔连通的对侧流体流动腔；以及可膨胀通道网，其安置于所述主要移植物部件上，包含所述同侧和对侧支腿上，所述可膨胀通道网经配置以接受可硬化的填充物材料以在所述可膨胀通道网处于膨胀状态时向所述主要移植物部件提供结构刚性，且所述可膨胀通道网包含安置于所述主要移植物部件的近端部分上的至少一个可膨胀套头，所述可膨胀套头经配置以密封患者的脉管的内表面；
近端锚部件，其安置在所述主要移植物部件的近端处且紧固到所述主要移植物部件，且具有以支柱紧固到自膨式远端支架部分的自膨式近端支架部分，所述支柱具有与邻近于所述支柱的近端支架部分或远端支架部分的横截面面积大体上相同或比其大的横截面面积；
至少一个同侧移植物延伸部，其具有安置于其中的流体流动腔，其中所述移植物延伸部的所述流体流动腔密封到所述主要移植物部件的所述同侧支腿的所述流体流动腔且与其流体连通；以及
至少一个对侧移植物延伸部，其具有安置于其中的流体流动腔，其中所述移植物延伸部的所述流体流动腔密封到所述主要移植物部件的所述对侧支腿的所述流体流动腔且与其流体连通。
2.根据权利要求1所述的移植物组合件，其中所述主要移植物部件具有约5cm到约10cm的轴向长度。
3.根据权利要求2所述的移植物组合件，其中所述主要移植物部件具有约6cm到约8cm的轴向长度。
4.根据权利要求1所述的移植物组合件，其中所述移植物延伸部的所述流体流动腔与所述主要移植物部件的相应远端支腿的所述流体流动腔重叠。
5.根据权利要求1所述的移植物组合件，其中所述近端锚部件的所述近端支架进一步包括多个倒钩，所述多个倒钩具有尖锐的组织啮合顶端，所述组织啮合顶端经配置而以经部署的扩展状态在径向向外方向上延伸。
6.根据权利要求1所述的移植物组合件，其中所述主要移植物和移植物延伸部的所述柔软的移植物材料包括分层的多孔或扩展的PTFE。
7.根据权利要求1所述的移植物组合件，其中所述移植物延伸部包括插入的自膨式支架，所述插入的自膨式支架安置在柔软的移植物材料层的至少一个外层与至少一个内层之间，且其中安置在移植物材料的所述外层与内层之间的所述插入的支架可由细长的弹性元件形成，所述弹性元件以多个纵向隔开的匝螺旋地缠绕成开放管状配置。
8.根据权利要求7所述的移植物组合件，其中所述插入的支架包含超弹性合金。
9.根据权利要求8所述的移植物组合件，其中所述超弹性合金包括超弹性NiTi合金。
10.根据权利要求7所述的移植物组合件，其中每一移植物延伸部的所述移植物材料进一步包括至少一个具有低渗透性的轴向区。
11.根据权利要求1所述的移植物组合件，其中所述近端锚部件的所述近端支架部分包括4冠支架。
12.根据权利要求1所述的移植物组合件，其中所述近端锚部件的所述远端支架部分包括8冠支架。
13.根据权利要求1所述的移植物组合件，其中所述近端锚部件的所述近端支架部分和所述远端支架部分包括超弹性合金。
14.根据权利要求13所述的移植物组合件，其中所述超弹性合金包括超弹性NiTi合金。
15.一种模块化脉管内移植物组合件，其包括：
分叉的主要移植物部件，其由柔软的移植物材料形成且具有约5cm到约10cm的轴向长度，所述分叉的主要移植物部件具有：其中的主要流体流动腔；同侧支腿，其具有与所述主要流体流动腔连通的同侧流体流动腔且具有至少约2cm的轴向长度；对侧支腿，其具有与所述主要流体流动腔连通的对侧流体流动腔且具有至少约2cm的轴向长度；以及可膨胀通道网，其安置于所述主要移植物部件上，包含所述同侧和对侧支腿上，所述可膨胀通道网经配置以接受可硬化的填充物材料以在所述可膨胀通道网处于膨胀状态时向所述主要移植物部件提供结构刚性，且所述可膨胀通道网包含安置于所述主要移植物部件的近端部分上的至少一个可膨胀套头，所述可膨胀套头经配置以密封患者的脉管的内表面；
近端锚部件，其安置在所述主要移植物部件的近端处且紧固到所述主要移植物部件，且具有以支柱紧固到自膨式远端支架部分的自膨式近端支架部分；
至少一个同侧移植物延伸部，其具有安置于其中的流体流动腔，其中所述移植物延伸部的所述流体流动腔密封到所述主要移植物部件的所述同侧支腿的所述流体流动腔且与其流体连通；以及
至少一个对侧移植物延伸部，其具有安置于其中的流体流动腔，其中所述移植物延伸部的所述流体流动腔密封到所述主要移植物部件的所述对侧支腿的所述流体流动腔且与其流体连通。
16.根据权利要求15所述的移植物组合件，其中所述主要移植物部件具有约6cm到约8cm的轴向长度。
17.根据权利要求15所述的移植物组合件，其中所述移植物延伸部的所述流体流动腔与所述主要移植物部件的相应远端支腿的所述流体流动腔重叠。
18.根据权利要求15所述的移植物组合件，其中所述近端锚部件的所述近端支架进一步包括多个倒钩，所述多个倒钩具有尖锐的组织啮合顶端，所述组织啮合顶端经配置而以经部署的扩展状态在径向向外方向上延伸。
19.根据权利要求15所述的移植物组合件，其中所述主要移植物和移植物延伸部的所述柔软的移植物材料包括分层的多孔或扩展的PTFE。
20.根据权利要求15所述的移植物组合件，其中所述移植物延伸部包括插入的自膨式支架，所述插入的自膨式支架安置在柔软的移植物材料层的至少一个外层与至少一个内层之间，且其中安置在移植物材料的所述外层与内层之间的所述插入的支架可由细长的弹性元件形成，所述弹性元件以多个纵向隔开的匝螺旋地缠绕成开放管状配置。
21.根据权利要求20所述的移植物组合件，其中所述插入的支架包含超弹性合金。
22.根据权利要求21所述的移植物组合件，其中所述超弹性合金包括超弹性NiTi合金。
23.根据权利要求20所述的移植物组合件，其中每一移植物延伸部的所述移植物材料进一步包括至少一个具有低渗透性的轴向区。
24.根据权利要求15所述的移植物组合件，其中所述近端锚部件的所述近端支架部分包含4冠支架。
25.根据权利要求15所述的移植物组合件，其中所述近端锚部件的所述远端支架部分包括8冠支架。
26.根据权利要求15所述的移植物组合件，其中所述近端锚部件的所述近端支架部分和所述远端支架部分包括超弹性合金。
27.根据权利要求26所述的移植物组合件，其中所述超弹性合金包括超弹性NiTi合金。
28.一种治疗患者的方法，其包括：
提供含有径向受约束的分叉的主要移植物部件的递送导液管，所述主要移植物部件由柔软的移植物材料形成，所述主要移植物部件在其中具有主要流体流动腔，所述分叉的主要移植物部件具有同侧支腿，所述同侧支腿具有与所述主要流体流动腔连通的同侧流体流动腔，所述分叉的主要移植物部件具有对侧支腿，所述对侧支腿具有与所述主要流体流动腔连通的对侧流体流动腔，所述分叉的主要移植物部件具有可膨胀通道网，所述可膨胀通道网安置于所述主要移植物部件上，包含所述同侧和对侧支腿上，且所述分叉的主要移植物部件具有近端锚部件，所述近端锚部件安置在所述主要移植物部件的近端处且紧固到所述主要移植物部件，且具有紧固到自膨式远端支架部分的自膨式近端支架部分；
将所述递送导液管轴向定位在所述患者的脉管系统内，使得所述递送导液管内的所述主要移植物部件与所述患者的主动脉的脉管缺陷以同延方式安置；
部署所述近端锚部件以便啮合所述患者的脉管系统的内表面，且将所述近端锚部件锚定到所述患者的主动脉；
用膨胀材料使所述主要移植物部件的所述可膨胀通道网膨胀；
提供含有径向受约束的自膨式对侧移植物延伸部的第二递送导液管；
将所述第二递送导液管轴向定位在所述主要移植物部件的所述对侧支腿中，其中所述对侧移植物延伸部的近端部分与所述主要移植物部件的所述对侧支腿的内部流体流动腔轴向重叠，且所述对侧移植物延伸部的远端部分与所述患者的对侧髂动脉的一部分轴向重叠；
通过释放所述径向约束而部署所述自膨式对侧移植物延伸部，以便在所述对侧移植物延伸部的所述内部流体流动腔、所述对侧支腿的流体流动腔与所述对侧髂动脉的流体流动腔之间形成密封；
提供含有径向受约束的自膨式同侧移植物延伸部的第三递送导液管；
将所述第三递送导液管轴向定位在所述主要移植物部件的所述同侧支腿中，其中所述同侧移植物延伸部的近端部分与所述主要移植物部件的所述同侧支腿的内部流体流动腔轴向重叠，且所述同侧移植物延伸部的远端部分与所述患者的同侧髂动脉的一部分轴向重叠；以及
通过释放所述径向约束而部署所述自膨式同侧移植物延伸部，以便在所述同侧移植物延伸部的所述内部流体流动腔、所述同侧支腿的流体流动腔与所述同侧髂动脉的流体流动腔之间形成密封。
29.一种模块化脉管内移植物组合件，其包括：
分叉的主要移植物部件，其由柔软的移植物材料形成，所述分叉的主要移植物部件具有：在其中的主要流体流动腔；同侧支腿，其具有与所述主要流体流动腔连通的同侧流体流动腔；对侧支腿，其具有与所述主要流体流动腔连通的对侧流体流动腔；以及可膨胀通道网，其安置于所述主要移植物部件上，包含所述同侧和对侧支腿上，所述可膨胀通道网经配置以接受可硬化的填充物材料以在所述可膨胀通道网处于膨胀状态时向所述主要移植物部件提供结构刚性，且所述可膨胀通道网包含安置于所述主要移植物部件的近端部分上的至少一个可膨胀套头，所述可膨胀套头经配置以密封患者的脉管的内表面；
近端锚部件，其安置在所述主要移植物部件的近端处且紧固到所述主要移植物部件，且具有以支柱紧固到自膨式远端支架部分的自膨式近端支架部分，所述支柱具有与邻近于所述支柱的近端支架部分或远端支架部分的横截面面积大体上相同或比其大的横截面面积；
至少一个同侧移植物延伸部，其具有安置于其中的流体流动腔，其中所述移植物延伸部的所述流体流动腔密封到所述主要移植物部件的所述同侧支腿的所述流体流动腔且与其流体连通；以及
至少一个对侧移植物延伸部，其具有安置于其中的流体流动腔，其中所述移植物延伸部的所述流体流动腔密封到所述主要移植物部件的所述对侧支腿的所述流体流动腔且与其流体连通。
30.一种模块化脉管内移植物组合件，其包括：
分叉的主要移植物部件，其由柔软的移植物材料形成且具有约5cm到约10cm的轴向长度，所述分叉的主要移植物部件具有：在其中的主要流体流动腔；同侧支腿，其具有与所述主要流体流动腔连通的同侧流体流动腔且具有至少约2cm的轴向长度；对侧支腿，其具有与所述主要流体流动腔连通的对侧流体流动腔且具有至少约2cm的轴向长度；以及可膨胀通道网，其安置于所述主要移植物部件上，包含所述同侧和对侧支腿上，所述可膨胀通道网经配置以接受可硬化的填充物材料以在所述可膨胀通道网处于膨胀状态时向所述主要移植物部件提供结构刚性，且所述可膨胀通道网包含安置于所述主要移植物部件的近端部分上的至少一个可膨胀套头，所述可膨胀套头经配置以密封患者的脉管的内表面；
近端锚部件，其安置在所述主要移植物部件的近端处且紧固到所述主要移植物部件，且具有以支柱紧固到自膨式远端支架部分的自膨式近端支架部分；
至少一个同侧移植物延伸部，其具有安置于其中的流体流动腔，其中所述移植物延伸部的所述流体流动腔密封到所述主要移植物部件的所述同侧支腿的所述流体流动腔且与其流体连通；以及
至少一个对侧移植物延伸部，其具有安置于其中的流体流动腔，其中所述移植物延伸部的所述流体流动腔密封到所述主要移植物部件的所述对侧支腿的所述流体流动腔且与其流体连通。
31.一种移植物延伸部，其包括：
安置在其中的流体流动腔；
至少一个可渗透PTFE材料层；
至少一个半渗透或大体上不可渗透PTFE材料层，其具有不可辨识的节点和原纤维结构；以及
插入的自膨式支架，其由细长的弹性元件形成，所述弹性元件以多个纵向隔开的匝螺旋地缠绕成开放管状配置，所述插入的自膨式支架安置于至少一个外部PTFE材料层与至少一个内部PTFE材料层之间。
32.根据权利要求31所述的移植物延伸部，其中所述插入的支架包括超弹性合金。
33.根据权利要求32所述的移植物延伸部，其中所述超弹性合金包括超弹性NiTi合金。
34.根据权利要求31所述的移植物延伸部，其中每一移植物延伸部的所述移植物材料进一步包括至少一个具有低渗透性的轴向区。
35.根据权利要求31所述的移植物延伸部，其中所述可渗透PTFE材料包括约10微米到约30微米的节点间距离。
36.根据权利要求31所述的移植物延伸部，其中所述可渗透材料具有约0.00005英寸到约0.005英寸的厚度。
37.根据权利要求31所述的移植物延伸部，其中所述半渗透或大体上不可渗透材料包括约0.00005英寸到约0.005英寸的厚度。
38.根据权利要求31所述的移植物延伸部，其中所述半渗透或大体上不可渗透材料包括大体上低的多孔度和具有多个互连的高密度区的闭合单元微结构，其中在所述高密度区之间不具有可辨识的节点和原纤维结构。
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