CN101108136A - 血管栓塞的可膨胀植入物 - Google Patents

血管栓塞的可膨胀植入物 Download PDF

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CN101108136A
CN101108136A CNA2007101411203A CN200710141120A CN101108136A CN 101108136 A CN101108136 A CN 101108136A CN A2007101411203 A CNA2007101411203 A CN A2007101411203A CN 200710141120 A CN200710141120 A CN 200710141120A CN 101108136 A CN101108136 A CN 101108136A
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microtubular
implant
implant device
blood vessel
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乔治·R·小格林
布赖恩·J·考克斯
罗伯特·F·罗森布拉思
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Abstract

一种用于栓塞血管动脉瘤的血管植入物装置，该装置构造成用于通过微导管进行血管内布设，其特征在于，该装置由多孔的亲水性水凝胶材料构成，该装置具有由热固化保持的压缩构形，其中，该压缩构形的尺寸定为能够通过所述微导管，并且，当该装置通过所述微导管时，该装置在亲水作用下能够由所述压缩构形膨胀成一个膨胀的动脉瘤栓塞构形。

Description

血管栓塞的可膨胀植入物
本申请是1999年7月2日提出的申请号为PCT/US99/15108(国家申请号99808315.1)的专利申请的分案申请。原案申请的发明名称为“血管栓塞的可膨胀植入物及其制造方法”。
发明背景
本发明涉及栓塞血管动脉瘤及类似的血管异常的方法和装置的领域。更具体地，本发明涉及(a)可以插入诸如动脉血管瘤之类的血管内以便在其中造成梗塞的可膨胀血管植入物；(b)制造可膨胀的植入物的方法；和(c)用此植入物栓塞一个血管病灶的方法和装置。
血管的栓塞是数种临床情况所希望的。例如已经把血栓形成用于控制血管出血，用于闭塞对肿瘤的供血，并且用于闭塞血管动脉瘤，尤其是颅内动脉瘤。近年来用血管栓塞治疗动脉瘤得到了相当的重视。在先技术中采用了几种不同的治疗方法。例如，Jr.Domandy等的美国专利4,819,637说明了一种血管栓塞形成系统，它用一种通过血管内导管发送到动脉瘤处的可脱离的囊。囊置于导管尖部带到动脉瘤处，然后在动脉瘤内用可固化液体(一般为聚合化树脂或者凝胶)充涨囊以闭塞动脉瘤。然后通过轻轻牵引导管使囊脱离导管。尽管这种囊形的栓塞形成装置可以提供多种动脉瘤的有效闭塞，但是在可固化液体固定后难于收回或者移动，并且难于成像观察，除非充以造影剂(contrastmaterial)。另外还有在膨胀过程中囊破裂和囊过早地从导管脱落的风险。
另一种方法是直接向需要闭塞的血管处注射液态的聚合体栓塞形成剂。一种用于直接注射技术的液态聚合物是快速聚合的液体，诸如氰基丙烯酸盐树脂，特别是异丁基氰丙烯酸盐树脂，其作为液体输送到目标地点处，然后就地聚合。另外还使用一种从载体溶液在目标地点沉淀的液体聚合物。这种栓塞形成剂的一个例子是与三氧化二铋混合的醋酸纤维素聚合物的二甲亚砜(DMSO)溶液。另一种是乙二醇共聚体的二甲亚砜(DMSO)溶液。与血液接触时，二甲亚砜(DMSO)扩散出去，聚合体析出并且快速硬化成与动脉瘤的形状相符的栓塞物。这种“直接注射”方法用的材料的其它例子公开于下列美国专利：Pasztor等的4,551,132；Leshchiner等的4,795,741；Ito等的5,525,334；和Greff等的5,580,568。
直接注射液态聚合体栓塞形成剂已经证实难于实施。例如聚合体材料从动脉瘤流出后进入相邻的血管中出现问题。另外，栓塞形成材料的成像要求造影剂与之混合，并且选择相容的栓塞形成剂和造影剂可能导致性能不太理想。而且难于精确地控制聚合体栓塞形成材料的散开，引起不正确的放置和/或材料过早硬化。而且，一旦栓塞材料散开和固化，难于移动或者取走。
另外一个表现出前景的方法是使用生成血栓的微螺圈。这些微螺圈可以用生物适应性的金属合金(典型采用铂和钨)或者适当的聚合物制造。如果用金属制造，螺圈可以带有涤纶纤维以增加血栓生成性。所述螺圈用微导管施放到血管病灶。微螺圈的例子公开于以下的美国专利：Ritchart等的4,994,069；Butler等的5,133,731；Chee等的5,226,911；Palermo等的5,312,415；Phelps等的5,382,259；Dormandy等的5,382,260；Dormandy等的5,476,472；Mirigian等的5,578,074；Ken等的5,582,619；Mariant等的5,624,461；Horton等的5,645,558；Snyder等的5,658,308；Berenstein等的5,718,711。
微螺圈法在处理颈部狭窄的小动脉瘤时取得一定的成功，但是微螺圈必须要紧密地填入动脉瘤中以避免引起重新导通的移动。微螺圈法在处理大动脉瘤时不太成功，尤其是颈部较宽的动脉瘤。微螺圈的一个缺点是不容易收回它们；如果螺圈移出动脉瘤就必须进行第二次手术以收回它并且放回需要的病灶。而且完全用螺圈填装动脉瘤在实际上也难于办到。
一种得到成功的特殊的微螺圈为Guglielmi氏可脱离螺圈(“GDC”)。GDC用一种通过焊接固定在不锈钢引导线上的铂线螺圈。在螺圈放置在动脉瘤中后，在引导线上加电流，电流足以熔化焊点，从而使螺圈从引导线上脱离。施加电流还在螺圈上产生正电荷，正电荷吸引带负电的血细胞，血小板和凝血因子，从而增加螺圈的凝血度。可以把不同直径和长度的几种螺圈装填进动脉瘤，直到把动脉瘤完全填充。螺圈就这样在动脉瘤内产生和保持血栓，防止其移位和破碎。
GDC方法的优点是如果螺圈从其所希望的病灶移开，能够撤出和重新安放它，并且加强了其促进在动脉瘤内形成稳定的血栓的能力。然而，同常规的微螺圈技术一样，成功地使用GDC技术基本上局限于有狭窄颈部的小动脉瘤。
另一个栓塞异常的血管病灶的方法是在此病灶内注射进生物适应性水凝胶，例如聚(2-羟基甲基丙酸盐)(pHEMA，或者PHEMA)；或者聚乙烯醇泡沫(PAF)。例如参见，如1986年11月出版的“生物材料”期刊第7卷，467-470页上发表的Horak等人的文章《用于血管栓塞的水凝胶II球形颗粒的临床应用》；1991年出版的“神经系统放射学”期刊第18卷，61-69页上发表的Rao等人的文章《交联的聚甲基丙烯酸甲酯中的水解微球体》；1979年6月出版的“放射学”期刊第131卷，669-679页上发表的Latchaw等人的文章《血管的聚乙烯泡沫栓塞及头部、颈部和脊柱的瘤损伤》。这些材料被用作在一种注射进血管病灶的载体液体中的微粒，该过程被证明是难于控制的。
另一个发展是把水凝胶材料形成为一个预先成型的植入物或插塞，借助于微导管等安装进血管病灶。例如，Mehta的美国专利5,258,042和Conston等的美国专利5,456,693。这些种类的插塞或者说植入物主要用于阻塞流经管状容器或者动脉瘤颈部的血液，它们不易于在动脉瘤之类的袋状血管结构中精确地植入，从而基本上填充此结构的整个内部空间。
US-A-5 750 585公开了一种形成为大孔性固体的可水胀性的泡沫基质，它包含：泡沫稳定剂和自由基可聚合的亲水烯烃单体的聚合体或共聚体，其中该单体与约0.1％-10％重量的多烯烃功能交联剂交联。此泡沫基质的特征在于快速胀大和高的水胀率。
WO98 04198公开了一种方法，该方法包括在动脉瘤内引入一种栓塞物质。此栓塞物质使组织能够在被动脉瘤变形了的区域内向内生长，从而治疗了动脉瘤。优选的栓塞材料是那些有开放孔隙结构的，如聚乙烯醇泡沫。此文中还公开一种导管，它可以用于把栓塞材料引入动脉瘤。
现在有长期感觉到的但是尚末得到满足的对动脉瘤进行治疗的装置和方法的需要，它们应当可以用血栓生成介质填充具有大范围的尺寸、构形、和颈部宽度的动脉瘤，并且不利的动脉瘤破裂或者血管损伤的风险要尽可能地小。还需要这样一种方法和装置，使得能够精确地区域性地布置介质，同时使得从目标病灶移开的可能性最小。另外，满足这些标准的方法和装置还应当在临床应用中容易使用。所述的使用方便，优选地还应当包括装置在动脉瘤中布置过程中及布置后有良好的显像性。
发明概述
简而言之，本发明的第一个方面是一种栓塞诸如动脉瘤等血管病灶的装置。其中，该装置可以由初始的构形受压缩成压缩构形，以借助于微导管等插入血管病灶，并且可以膨胀，例如可以就地膨胀成一种与血管病灶的形状和尺寸基本相吻合的膨胀构形，从而栓塞病灶。根据本发明的装置的特征在于：处于初始构形的装置具有血管病灶的模型的形式。优选地，该装置的初始构形具有血管病灶的缩小比例模型的形式。
在一个优选实施例中，植入物由亲水的、大孔性的、聚合的水凝胶泡沫材料制成，尤其是用形成为大孔性固体的可以水胀的泡沫填料，它包含泡沫稳定剂和自由基可聚合亲水烯烃单体的聚合体或共聚体，其中该单体与最多可达10％重量的多烯烃功能交联剂交联。对材料进行了改性，或者说含有添加剂，以使植入物能够用常规的影像技术成像。
本发明的另一个方面涉及一种用于栓塞血管病灶的血管植入物装置，该装置具有一种压缩了的构形，从它可以膨胀成基本上密接血管病灶的形状和大小的膨胀后的构形。并且，根据本发明的植入物装置的特征在于该装置基本上由大孔性的、亲水的水凝胶泡沫材料形成。
本发明的另一个方面涉及一种用于通过微导管输送到血管病灶栓塞血管动脉瘤的血管植入物装置，该装置由多孔的亲水性水凝胶材料构成，该装置具有一个初始构形，初始构形的大小使得该装置能够通过所述微导管，并且该装置在亲水作用下可以由所述初始构形膨胀成一个膨胀构形，所述膨胀构形用于栓塞动脉瘤。
血管植入物可以由以下方法获得，该方法包括以下步骤：(a)通过扫描血管病灶以产生一个数字化扫描数据集，做出血管病灶的图像；(b)用扫描数据集产生一个血管病灶的三维数字化的虚拟模型；和(c)用虚拟模型形成一个血管病灶的实体模型形式的血管植入物装置，此植入物由可压缩和可膨胀的生物适应性泡沫材料制造。在一个特定的实施例中，形成步骤(c)包含子步骤：(c)(1)用虚拟模型形成一个缩小比例的血管病灶的实体模型；和(c)(2)用此模型制造一个缩小比例的血管病灶的实体模型形式的血管植入物。
成像步骤可以通过扫描技术实现，例如计算机断层摄影(一般称为CT或者CAT)，磁共振成像(MRI)、磁共振血管扫描术(MRA)，或者超声扫描。通常由扫描装备附带和使用的软件，通过把扫描数据集制成血管病灶的三维数字化模型重建扫描数字集。然后由软件转化成可用于商业应用中的CAD/CAM程序的形式，以通过立体图像技术产生缩小比例的实体模具。把适宜的植入材料，优选为大孔性水凝胶泡沫材料，以液体或者半液体的状态注入到模型中。硬化后从模型中取出，用作血管病灶的缩小比例实体模型的形式的植入物。
一种栓塞血管病灶的方法，包含以下步骤：(a)血管内传送一根微导管，使其远端在血管病灶内；(b)提供一个血管病灶的缩小比例实体模型形式的血管植入物，植入物由可压缩的和可膨胀的生物适应性泡沫材料制成；(c)把植入物物压缩成压缩构形尺寸，以通过微导管；(d)把处于压缩构形的植入物经微导管送入，使植入物从微导管的远端露出进入血管病灶；和(e)就地膨胀植入物以填充血管病灶。
本发明的另一个方面涉及一种栓塞血管病灶的装置，包含：具有远端和近端的微导管；具有初始构形的血管植入物装置，其中此装置可以从这种初始构形压缩成压缩后的构形，并且可以从压缩后的构形膨胀成基本上密接血管病灶的形状和大小的膨胀后构形；含在微导管内的、有可拆卸地连接植入物装置的远端的保持元件；布设元件，可与植入物装置接合，从而在植入物装置从微导管的远端露出时把植入物装置从保持元件分离开。并且根据本发明的装置的特征在于，植入物装置是血管病灶的模型的形式，并且布设元件的尺寸定得可与保持元件一起通过微导管。
本发明还有一个方面涉及一种栓塞血管病灶的装置，包含：具有远端和近端的微导管；由亲水性水凝胶泡沫材料形成的血管植入物装置，该植入物装置具有一个初始构形，将该构形的尺寸定为可以从微导管近端穿过微导管并从其远端穿出，该植入物装置在亲水作用下能够从初始构形膨胀成膨胀构形；含在微导管内的保持元件，该保持元件具有一远端，该远端以可拆卸方式连接到植入物装置；以及细长的、挠性的管状布设元件，可操作地与保持元件关联，并且可与植入物装置接合，从而在植入物装置从微导管的远端露出时将植入物装置与保持元件分开。
植入物装置在其优选实施例中是由可模制的、可亲水膨胀的、生物适应泡沫材料制造的，它有一个血管病灶的缩小比例实体模型形式的初始构形，它可以压缩成一种装配进微导管中的压缩构形，并且可以水胀成一个膨胀构形，以此构形尺寸基本上密接和填充血管病灶。可选地，植入物装置可以由一种不亲水的泡沫材料构成，它的初始构形基本上与血管病灶具有相同的尺寸和形状，并且它在从其压缩构形释放后自动地恢复其初始的构形。
保持元件优选为一根柔性丝线，其远端被设置成当植入物装置处在受压缩构形下时可脱开地与植入物装置接合，从而在微导管的远端插入在血管病灶内时，把植入物装置保持在微导管的远端内。此线可以连同布设元件沿远端的方向轴向移动，以把植入物从微导管远端暴露，并且可以向布设元件移近，以将植入物装置推向布设元件的近端，从而把植入物装置推离此线。从而释放进血管病灶，植入物装置膨胀成膨胀后的构形，用此构形它基本上密接并且填充血管病灶。
本发明具有多个显著的优点。特别是本发明提供一种有效的血管栓塞植入物，它可以以卓越的区域控制布设在血管病灶内，与在先技术的植入物装置比使血管破裂、组织损伤或者移动的风险最小。而且，通过按它要植入的实际血管病灶做模型，得到促进有效栓塞的在病灶内的密接配合，并且它可以以高度压缩的构形发送到病灶中的能力方便了用微导管进行精确高效的可控制的布设。另外，制造植入物装置的方法通过将植入物装置按照每个具体的病灶做成模型，能够有效地栓塞有广范围尺寸、构形、和(特别是动脉瘤中)颈部宽度的血管病灶。从下面的详细说明可以更充分地了解本发明的这些优点和其它优点。
附图简要说明
图1是根据本发明的制造方法的优选实施例的生产血管植入物的方法的流程图；
图2是根据本发明的血管植入物装置方面的优选实施例的血管植入物的透视图，示出了植入物在其初始构形；
图3是图2的植入物的正视图，示出了植入物在其受压缩的构形；
图4是图2所示出了植入物的透视图，示出了植入物在其受膨胀的构形；
图5是根据本发明的栓塞方法方面的一个优选实施例，栓塞血管病灶的方法中所用的植入物装置的截面图；而
图6至图10是根据本发明的栓塞方法方面的优选实施例珠栓塞血管病灶(特别是动脉瘤)的方法的步骤的半示意图。
本发明详述
制造血管植入物的方法。本发明的第一个方面是制造一种血管植入物装置的方法。制造方法的优选实施例的步骤如图1中的流程图中的说明性方框所示。
示于图1中的方框10中的第一步骤是产生其中要安装栓塞用植入物的动脉瘤之类的血管病灶的图像的步骤。这个图象产生步骤是通过用任何一种常规图像技术扫描病灶进行的，所述技术包括计算机断层摄影(一般称为CT或者CAT)，磁共振成像(MRI)、磁共振血管扫描术(MRA)，或者超声扫描等。
成像步骤的结果是一个储存在一个计算机存储器中的数字化扫描数据集，从存储器把数据集取出用于运作下一个步骤；计算机控制重建血管病灶三维数字化实体模型(图1的方框2)。产生三维数字模型的步骤通常由为此目的设计的、扫描装备附带和使用的软件进行。
然后把三维数字化的虚拟模型转化成可用于市售的CAD/CAM程序(方框14)的形式，此程序控制立体图像工艺(方框16)产生形成植入物装置的模具。虚拟模型转化由市售软件进行，例如，可以从德克萨斯的Cyberform国际有限公司和明尼苏达的Stratasys公司处购得。模具(未示出)优选地按血管病灶成比例缩小，比例约1∶2到约1∶6，最好是1∶4。可选地，模具可以是“实物大小”(即1∶1)；也就是说，血管病灶的全尺寸或者说近于全尺寸的复制。此模具用于通过常规的模制技术制造血管植入物装置(方框18)。
植入物装置。图2所示是根据本发明的优选实施的血管植入物装置20，表现为从模具中取出的，未压缩的或者说预压缩的初始构形。优选地，植入物装置20直接地模制在细长的、桡性的、诸如保持线22那样的丝状保持元件的远端上，用于以下所述的目的。保持线22优选地有一个终止于顶球24(图5)的远端，用于较好地把植入物装置20保持其上。
在优选实施例中，植入物装置20用生物适应的，大孔性，亲水的水凝胶泡沫材料制造，尤其是用形成为大孔性固体的可以水胀的泡沫基体，包含泡沫稳定剂和自由基可聚合亲水烯烃单体的聚合体或共聚体，其中该单体与最多可达10％重量的多烯烃功能交联剂交联。一种适宜的这类材料说明于Park等的美国专利5,750,585中，其公开在此引作参考。另一种适宜的材料是多孔的水合聚乙烯醇泡沫(PAF)凝胶，是由水和能与水合的有机溶剂组成的混合溶剂的聚乙烯醇溶液制备的，例如，在Hyon等的美国专利4,663,358中所述，其公开在此引为参考。另一种适宜的材料是PHEMA，如前面引证的文献所述。见前述Horak等和Rao等人的专利。泡沫材料优选地空隙率至少约90％，并且其亲水特性在完全水合时至少约90％的含量是水。
在优选实施例中，植入物装置20在其初始的预压缩的构形时，将有与血管病灶的同样构形，但是可以搞得较小，带有大小为2到6的系数。植入物装置20的材料及其初始尺寸是这样选择的：使植入物装置20可胀大或者说可膨胀成接近血管病灶的尺寸，主要地是通过从血浆中亲水吸收水分子，其次通过用血液填充其孔。结果是如图4所示的，膨胀后的植入物装置20的构形大得足以填充血管病灶。
可选地，植入物20装置可以这样地模制：使它的初始的预压缩的构形是“实体大小”，即接近血管病灶的大小。在此情况下，优选材料是可压缩的、非亲水的聚合体泡沫材料，如聚胺基甲酸酯。在临床实践中，非亲水的植入物装置20优选地制造得稍小于实际的实体大小，以补偿由于填充孔隙的胀大。
植入物装置20的泡沫材料，不论是亲水的或是非亲水的，都优选地改性，或者含有添加剂，以使植入物装置20可以通过常规的影像技术图像化。例如，泡沫可以浸以非水溶性的不透射线的材料，如“微囊包装”期刊1989年第6卷，No.2，233-244页上所发表的Thanoo等人的文章《不透射线的水凝胶微球》中提到的硫酸钡。可选地，如“生物医学材料研究”期刊1997年第34卷，183-188页上所发表的Horak等人的文章《新式不透射线的PHEMA基的水凝胶颗粒》中提到的：水凝胶单体可以与不透射线材料共聚。
不论植入物装置20是用什么材料制造，植入物装置20必须被压缩到其初始尺寸的几分之一，优选地压缩到基本上圆柱形或者菱形构形，如图3所示。如人们所熟知的，可以通过挤压植入物装置20，或者以任何适宜的夹具或工具(未示出)使之卷曲，然后通过加热和/或干燥把它“固定”成压缩后的构形，以实现植入物装置20的压缩。这种压缩的目的在下文结合使用植入物装置20栓塞血管病灶的方法说明。
栓塞血管病灶的方法和装置。用植入物装置20栓塞血管病灶的方法用一种植入物装置30进行，其优选的实施例见图5。植入物装置30含有：保持元件或者说线22；微导管32；和细长的、桡性的、中空的、起植入物布设元件作用的管状的元件34(优选为一缧圈)，后者在下文说明。植入物装置20附着在保持线22的远端的同时，保持线22的近端插入进植入物布设元件34的远端，并且轴向地穿过植入物布设元件34，直到植入物装置20的近端处在或者说紧密地邻接在植入物布设元件34的远端。植入物布设元件34尺寸定得用于轴向地通过微导管32。这样，在植入物装置20从其近端伸出的同时，植入物布设元件34可以插入微导管32的近端(未示出)并且轴向经其通过，直到植入物装置20从微导管32的远端露出，如图5所示。
当处于压缩的构形时，植入物装置20的最大的外径小于微导管32的内径，从而使植入物装置20可以通过微导管32。如上所述，植入物装置20在插入微导管32以前优选地被压缩和“固定”。
图6至图10示用植入物装置20栓塞血管病灶40的方法所用的步骤。示于各图中的血管病灶40典型地是动脉瘤，但是本发明不限于任何特殊类型的受栓塞的血管病灶。
首先，如图6所示，微导管32用常规的手段在血管内穿行，直到其远端处在血管病灶40内。此穿行操作通常是通过以下步骤实现的：首先沿所希望的微导管路径引入一根导管引导线(未示出)，然后套在导管引导线上送进微导管32，直到微导管32基本上位于如图6所示的位置。然后取出导管引导线。
随着植入物装置20从其远端延伸，植入物布设元件34然后通过微导管32，直到植入物装置20从微导管32的远端露出进入血管病灶40如图7和8所示。当把植入物装置20插入导管32时，可以把一种生物适应性的非水液体，例如聚乙二醇注射进微导管32中以防止植入物装置20因水合过早膨胀，并且降低与微导管32内部的磨擦。植入物装置20从而从微导管32暴露进入血管病灶40，植入物装置20开始在血管病灶40内从血液中吸收含水液体，以释放其“固定”，使之能够开始采取其膨胀后的构形，如图9所示。然后，如果植入物装置20是亲水材料的，它继续因植入材料的亲水水合作用而膨胀，也因血液填充其孔隙而膨胀。如果植入物装置20是非亲水的材料的，其膨胀则只因后一机制膨胀。
最后，当植入物装置20在充分进行时(当其完成时不是必须的)，把保持线22向植入物布设元件34拉近，借助于植入物布设元件34施加于其上的压力把植入物装置推离保持线22的末端。这时，如图10所示，植入物装置20脱离了植入物装置30，可以继续地膨胀直到它基本上填充血管病灶40。然后撤出植入物装置30，将植入物装置20留在适当的位置以栓塞血管病灶40。
尽管上面说明了本发明的优选实施例，领域内的一般技术人员可以推想出多种变化和修改。例如，除了对每名患者量体裁衣地制造植入物装置，还可以制造种种“标准”尺寸和形状的植入物装置，然后根据血管病灶的影像为每位患者选择特定的植入物装置。在此情况下，图1所示的制造方法可以修改成：首先生成各个标准化植入物的三维数字模型(方框12)，然后按方框14、16和18所示的序列步骤进行。成像(方框10)要在栓塞化早期步骤中进行，接着选择一个标准化的植入物。

Claims (8)

1.一种用于栓塞血管动脉瘤的血管植入物装置(20)，该装置构造成用于通过微导管进行血管内布设，其特征在于，该装置由多孔的亲水性水凝胶材料构成，该装置具有由热定型保持的压缩构形，其中，该压缩构形的尺寸定为能够通过所述微导管，并且，当该装置通过所述微导管时，该装置在亲水作用下能够由所述压缩构形膨胀成一个膨胀的动脉瘤栓塞构形。
2.如权利要求1所述的装置，其中，该装置的膨胀构形与动脉瘤的形状和大小基本一致。
3.如权利要求1或2所述的装置，其中，该装置呈整体模制件的形式。
4.如权利要求1-3中任一项所述的装置，其中，所述材料为泡沫材料。
5.如权利要求4所述的装置，其中，该泡沫材料为大孔性材料。
6.一种栓塞血管病灶的装置，包括：
具有远端和近端的微导管(32)；
由亲水性水凝胶泡沫材料形成的血管植入物装置(20)，该植入物装置具有初始的压缩构形，该压缩构型通过热定型保持，该压缩构形的尺寸定为能够从微导管的近端通过微导管并从其远端穿出，该植入物装置能够主要在亲水作用下从初始的压缩构形膨胀成膨胀构形；
含在微导管内的保持元件(22)，该保持元件具有一远端，该植入物装置直接模制在该远端上；以及
细长的、挠性的管状布设元件(34)，该布设元件以可操作方式与保持元件关联，并且能够与植入物装置接合，从而在植入物装置从微导管的远端露出时将植入物装置与保持元件分开。
7.如权利要求6所述的装置，其中，该布设元件的尺寸定为能够从微导管的近端轴向地通过该微导管到达其远端，该布设元件具有能够与该植入物装置接合的远端；
其中，在布设元件通过微导管时，保持元件能够与布设元件一起移动，并且还能够在相对于布设元件远端的第一和第二位置之间移动，从而当布设元件通过微导管时，该植入物装置退出微导管的远端，并且在保持元件从第一位置移动到第二位置时，该植入物装置与保持元件分开。
8.如权利要求6或7所述的装置，其中，该保持元件包括细长的、挠性的、丝状的元件，该丝状元件轴向穿过该布设元件，并且能够相对布设元件在第一和第二位置间移动。
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