CN1298287A - 形成血管栓塞的装置和方法 - Google Patents
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Abstract
一种血管栓塞装置,可以经微导管布置,它包含一个挠性的细长布置管,此管尺寸定得可以适于经所述微导管的空腔插入,和一个丝状的栓塞形成装置,它可松脱地附着在所述布置管的远端,所述栓塞形成装置可以从软的、柔顺的状态可控制地转变成刚性或者半刚性的状态。所述栓塞形成装置可包括一种聚合材料,此材料可以通过与血液或者比血液冷的液体接触而转变,或者,它可以包括一种金属材料,它可以通过电蚀转变。所述栓塞形成装置可以是一种连续的丝状压塑聚合物;一种填充以聚合材料的细长的微螺圈;一种包括聚合物相互链接部分的细长的多链段的链;或者一种通过电蚀融合的细长的金属链段的链。通过布置微导管使其远端邻接动脉瘤用此装置闭塞动脉瘤;通过微导管把此栓塞形成装置放入动脉瘤中,使之在瘤中形成网状团块;并且把此装置从软的、柔顺的状态可控制地转变成刚性或者半刚性的状态。所述的栓塞形成装置优选地通过可松脱地附着在一个挠性的细长布置管布置,所述布置管穿过所述的微导管,并且,在适宜地安放所述的栓塞形成装置后,把所述栓塞形成装置从管上脱离。
Description
发明背景
本发明一般地涉及血管闭塞的装置和方法。更具体地,涉及通过在血管中的目标地点(例如动脉瘤)形成血栓闭塞血管的装置和方法。
血管的血栓形成设计用于数种临床情况。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,尤其是冠状动脉内的动脉瘤。近年来,利用形成血管栓塞治疗动脉瘤地引起了人们极大注意。在先技术中采用了几种不同的治疗形式。例如,Dormandy等的美国专利4,819,637说明了一种血管栓塞形成系统,它用一种可脱离的囊通过血管内导管发送到动脉瘤处。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,但是在可固化液体凝固后难于收回或者移动,并且难于成像观察,除非充以造影剂。另外还有在膨胀过程中囊断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物栓塞形成剂。一种用于直接注射技术的液态聚合物是快速聚合的液体,诸如氰丙烯酸树脂,特别是异丁基氰丙烯酸树脂,在输送到目标地点处时是液体,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态聚合物。这种栓塞形成剂的一个例子是与三氧化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物的二甲亚砜(DMSO)溶液。与血液接触时,二甲亚砜(DMSO)扩散出去,聚合物沉淀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。
直接注射聚合体栓塞形成剂已经证实难于实施。例如聚合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与之混合造影剂,并且选择相容的栓塞形成剂和造影剂可能导致性能上的折衷处理,结果使性能不太理想。而且难于精确地控制聚合体栓塞形成材料的布置,引起不正确的放置和/或材料过早硬化。而且一旦材料布置和固化,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(典型地铂和钨)或者适当的聚合物制造。如果用金属制造,螺圈可以设涤沦纤维以增加血栓生成性。所述螺圈用微导管施放到血管的地点。微螺圈的例子公开于以下的美国专利:Ritchart等的4,994,096;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的5,582,619;Mariant的5,624,461;Horton的5,645,558;Snyder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移动而导致重新开渠。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要进行第二次手术以收回它并且放回需要的位置。而且用螺圈完全地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、血小板和纤维蛋白原,从而增加螺圈的血栓形成性。可以把不同直径和长度的几种螺圈装填进一个动脉瘤,直到把动脉瘤完全填充。这样螺圈就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位置移开,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。
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实质上填充大范围的尺寸、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。还一直需要这样一种方法和装置,使得能够精确地局部布置介质,同时使得从目标位置移开的可能性最小。另外,满足这些标准的的方法和装置还应当相对地容易在临床应用中使用。所述使用方便,优选地还应当包括在动脉瘤中布置装置时和布置装置后有良好的显像性。
技术方案
广而言之,本发明的一个方面是一种栓塞形成装置,包含一个血栓生成介质,它布置成软的、柔顺的状态,并且在布置后可控制地转化成刚性或者半刚性的状态。另一个方面,本发明是一种装置,用于在动脉瘤内布置前述的栓塞形成装置。本发明的另一个方面是一种使用上述的栓塞形成装置栓塞血管处、尤其是动脉瘤的方法。
在第一个优选实施例中,栓塞形成装置包含一个连续的、丝状的压塑聚合体“转变材料”,它在软的、自粘的、柔顺的状态下插入动脉瘤。插入一或者多个这样的栓塞形成装置产生一团块物质,基本上填充动脉瘤,并且基本上与动脉瘤的内部形状一致。取决于实际上采用的聚合材料,采取任何几个机制之一可控制地把转变材料转变成刚性或者半刚性状态,其中,所述材料在动脉瘤内形成稳定的血栓生成“插塞”。例如,所述材料可以以稍高于体温的温度注射,然后通过与患者的血液接触或者注射冷却含盐溶液,使之冷却成其刚性或者半刚性的状态。另外,聚合材料可以暴露于一种硬化剂,硬化剂与所述材料物理地或者化学地反应,达到向刚性或者半刚性状态的转变。再一种是,聚合材料可以与一种水溶性的、生物适应的增塑剂混合,后者在血液中溶出,从而剩下刚性或者半刚性的聚合体结构。
在另一个优选实施例中,栓塞形成装置含有一个细长的挠性微螺圈,其内部含有转变材料。把微螺圈以转变材料在其软的柔顺的状态下布置在动脉瘤中,然后转变材料通过任何适当的机制刚性化,如上所述,从而就地刚性化微螺圈。
在另一个优选实施例中,栓塞形成装置含有一个细长的活节连接的链段挠性链,所述链段连接在一起形成一个安装在动脉瘤中的软的分链段的细丝。在放置进动脉瘤后,取决于所述链段的材料,通过几个机制之一融合链段来刚性化分链段的细丝。例如,如果所述链段是金属的,链段可以由流经所述装置的电流电蚀融合在一起。如果链段至少部分地由聚合体“转变材料”制造,装置向刚性或者半刚性状态的转变可以通过上述机制之一进行。
在又一个优选实施例中,栓塞形成装置是一个高度柔顺性的链样结构,含有多个相互连接的空心链环或者说链段。每个链段有一个有槽的、磨菇形的头部,和一个凹窝部,凹窝部的尺寸和形状都做得用于容纳相邻链段的头部。空心的链段使栓塞装置在希望时能够经一个引导线(未示)插入动脉瘤。一经插入了装置后,就把一种聚合体转变材料,在软的、柔顺的状态下,注射进装置的内部,然后可以如上所述地转变成其刚性或者半刚性的状态。变通地,所述链段可以是金属制造的,然后通过电蚀方法融合在一起。
布置栓塞形成装置的装置的一个优选实施例含有一种挠性的细长的空心布置管,此管有一个轴向的通道并且在其远端有一个杯形的夹持元件。所述的夹持元件构形和尺寸定得通过磨擦接合来夹持栓塞形成装置的近端,它有一个基部,基部有一个与轴向空腔连通的开口。所述布置管(或者至少在其远端)优选地由放射线透不过的材料制造,例如生物适应性的金属合金,从而在布置栓塞形成装置时方便显像,而不需要在栓塞形成装置本身加入放射线透不过的物质。
用此装置布置栓塞形成装置的优选的方法是:把其上如上所述连接有栓塞形成装置的布置管经一个微导管插入并且推进,所述微导管已经先行通过外科领域内的一般技术人员所公知的手段从血管进入到动脉瘤处。挠性布置管和柔软的栓塞形成装置通过微导管受到绕布置管和柔软的栓塞形成装置外面经微导管流动的液体(例如盐水溶液)的辅助和促进。布置管经微导管推进直到栓塞形成装置完全插入动脉瘤内。最后把液体(例如盐水溶液)经所述轴向空腔注射进入布置管的夹持元件。液体的压力把栓塞形成装置推出夹持元件,从而使栓塞形成装置脱离布置管。然后把布置管撤出微导管。如果需要多于一个的栓塞形成装置填充动脉瘤,上述过程可以反复进行,直到完全充满动脉瘤。
本发明提供数个超过在先技术的优点。例如,本发明的栓塞形成装置可以以软的、柔顺的状态布置在动脉瘤内,从而使动脉瘤破裂或者血管损伤的风险最小。栓塞形成装置的位置可以以一定的精确性控制,并且直到与布置管脱离前,其布置可以逆转。从而使移出动脉瘤的风险最小。而且本发明的栓塞形成装置可以用于各种各样形状和尺寸的动脉瘤,它不限于小的动脉瘤或者有狭窄的颈部的动脉瘤。
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。
附图简述
图1是用于布置根据本发明的栓塞形成装置的装置的优选实施例的正视图;
图2是沿图1的2-2线取的截面图,表现载有根据本发明的第一实施例的栓塞形成装置的布置装置;
图3和4是根据本发明的栓塞形成装置凭借图1和2的装置在动脉瘤中布置过程中的理想化视图;
图5是根据本发明的第二个实施例的栓塞形成装置的一个实施例的正视图;
图6是在图5由点划线6标出的区域的详图;
图7是图5和图6的实施例一个修改的栓塞形成装置的部分正视图;
图8是沿图7的8-8线取的截面图;
图9是图5和图6的实施例另一个修改的栓塞形成装置的部分正视图;
图10是沿图9的10-10线取的截面图;
图11是根据本发明的第三个实施例的栓塞形成装置的端视图;
图12是沿图11的10-10线取的截面图;而
图13-16是截面图,类似于图10,表示本发明的栓塞形成装置的第三个实施例的进一步修改。
图1和2表示了用于布置根据本发明的栓塞形成装置12的装置10的优选实施例。装置10含有一个具有轴向空腔15的微导管14和一个可通过微导管14的轴向空腔1 5插入的布置管16。微导管14是常规设计,市场上就有许多适用于装置10的微导管可用。微导管14的近端设有一个接斗18,用于与液体(例如盐水溶液)源(未示)连接,液体的流动用于促进布置管16通过微导管14,这将于下文说明。微导管14,或者至少是其远端,优选地由放射线透不过的材料制造,例如生物适应性的金属。变通地,可以用适当的塑料制造,用在接近其远端处设一个放射线透不过的塞子(未示),这在本领域内是公知的。
布置管16是长、薄、空心、高度挠性的管子,有一个轴向的通道20,而且总长度稍大于微导管14的长度。布置管16有一个近端,一个入口套管22附着在其上,与轴向通道20连通并且用于连接液体源(未示)。所述液体源含有生物适应性液体,可以在压力下把此液体发送到入口套管22,用于下文所述的目的。布置管16的远端设有一个杯状的接斗24,它起夹持元件的作用,构形得用于与栓塞形成装置12的近端磨擦接合。夹持元件24的内部与布置管16的轴向通道20通过一个轴向钻孔26连通。布置管16长度的主体部分从夹持元件24向近端延伸,用一段连续的金属螺旋线形成为高度挠性和柔顺性的外部28。所述外部28同心地包绕内部30,内部30是由高度挠性的聚合材料制造的,其内部界定一个轴向通道20的远端部分,这个远端部分与夹持元件24的轴向钻孔26连接。外部28和内部30的近端两者都连接到内过渡套管32的远端,过渡套管的近端连接到近端的管段34的远端,后者可以用挠性的聚合材料制造。一个轴向钻孔36横向穿过这段过渡套管32,为内部30中的轴向通道20的远端部分和界定在远端管段34内的轴向通道20的近端部分之间提供液体连通。前述的入口套管22连接到近端管段34的近端。
如图1和2所示,栓塞形成装置12含有一个连续的丝状的压塑聚合体“转变材料”。所述转变材料在初始时是软的、自粘的、柔顺状态的。当材料在此状态时,把栓塞形成装置12插入到动脉瘤中。插入产生一团网状的物质,它基本上填充动脉瘤并且基本上与动脉瘤的内部形状一致。取决于所用的特定聚合材料,然后用几个机制的任何一个,可控地把转变材料转变为刚性或者半刚性的状态,其中所述材料在动脉瘤内形成稳定的、血栓生成的“塞子”。例如,栓塞形成装置12可以在稍高于体温的温度下注射,然后通过与患者的血液接触冷却,或者通过注射冷却盐液冷却成其刚性或者半刚性的状态。另外,聚合材料可以暴露于一种硬化剂,硬化剂与所述材料物理地或者化学地反应,达到转变材料向刚性或者半刚性状态的转变。再一种是,聚合材料可以与一种水溶性的、生物适应的增塑剂(如下所述)混合,后者在血液中溶出,从而留下刚性或者半刚性的聚合体结构。
在布置前,以及在栓塞形成装置12的材料处在初始的软的、柔顺状态下的同时,把栓塞形成装置12的近端推入布置管16的夹持元件24,在此被磨擦地滞留在位。因微导管14的远端事先布置在目标动脉瘤(由图3和4中的标号36标示)附近,把栓塞形成装置12的远端(未示)插入微导管14近端的套管18中。在栓塞形成装置12和布置管16经微导管14的空腔15推进时,使一种液体,如盐水溶液,流经微导管14,如图2中标以标号38的箭头所示。液体的流动辅助经微导管14输送栓塞形成装置12和布置管16,直到布置管16的远端充分地在动脉瘤36(图3)内,在此点栓塞形成装置12开始在动脉瘤内形成网状的、血栓生成团块,或者说塞子40。栓塞形成装置12的近端在经布置管的轴向通道20和夹持元件24的轴向钻孔26注射的液体(诸如盐水溶液)的压力作用下与布置管16脱离。
如果动脉瘤36的尺寸要求不止一个栓塞形成装置12以完全填充之,则把布置管16经微导管14撤出,并且重新装载上另一个栓塞形成装置12,然后重复上述布置过程达到足以完全填充动脉瘤(图4)所需要的频次。如图4所示,然后以上述的方式把最后一个栓塞形成装置12从布置管16脱离开,并且把布置管16从微导管14中撤出。
用于经微导管14输送布置管16和栓塞形成装置12的液体,以及用于把形成装置12从布置管16上脱开的液体(即,“布置液体”),选择得使它们不影响栓塞形成装置的材料从其软的状态转变成刚性或者半刚性的状态的转变。这样,例如,如果转变材料通过由稍高于体温(例如由约40℃)冷却到接近正常体温(37℃)达到转变,这些布置液体就以较高的温度注射,从而使转变不会过早地发生。
一旦网状的血栓生成团块40完全地填充了动脉瘤36,如图4所示,安装在动脉瘤36内的一个或多个栓塞形成装置12的转变材料就可以,取决于所述材料本身的性质,通过一个上述的机制转变成其刚性或者半刚性的状态。例如,“转变液体”,诸如在所需要温度的盐水溶液,经微导管14注射,以浴泡团块40,从而达到所希望的转变。
图5和6表示一个根据本发明的第二个优选实施例的栓塞形成装置50。栓塞形成装置50含有一个空心金属微螺圈52,其内部充以聚合体转变材料的芯54。栓塞形成装置50通过芯54的材料从其软的、柔顺的状态转变成其刚性或者半刚性的状态而刚性化,如上所述。栓塞形成装置50在布置上与前述实施例所用的布置方法相同。
栓塞形成装置50的改型示于图7至10。在图7和8中,栓塞形成装置50′含有一个空心的金属微螺圈52′,其远端被一个端罩56封闭。装置50′没有芯。相反,当微螺圈52′被插入动脉瘤时,还没有从布置管16脱离前,通过布置管16的轴向通道20和夹持元件24的轴向钻孔26注射一种可流动的转变材料到微螺圈52′的内部中。注射转变材料由图7中通过标以标号58的箭头表示。安装的微螺圈52′的挠性和弯曲,如图8所示,使得螺圈之间的间隙开通,使转变材料能够从微螺圈流出,如标以标号60的箭头所示。然后,转变材料可以被转变成其刚性或者半刚性的状态,从而刚性化微螺圈52′。从螺圈之间的间隙流出的暴露的转变材料,进一步地刚性化并且增强装置50′的血栓生成性。
图7和8的栓塞形成装置59′的优点还可以通过图9和10所示的另一个变型例实现。在此后一个变型中,栓塞形成装置50″含有一个空心的金属微螺圈52″此金属微螺圈有一个封闭其远端的端罩56″ 。微螺圈52″在其全长上有多个小孔62,但图中仅示出一个。小孔62为转变材料的流出提供附加的途径,如图10中标以标号64的箭头所示。
栓塞形成装置的第三个优选实施例示于图11至16的几个不同形式。先参见图11和12,根据第三个实施例的栓塞形成装置70是一个链状的结构,含有多个相互连接的金属链环或者说链段72,各在其一端有一个凹窝74并且在另一端有一个开槽的球76。每个凹窝74的尺寸定得能容纳相邻链段72的球76,球76的开槽结构使它们能够稍微受压以进入凹窝74。球76宽松地容纳在凹窝74中,并且链段72的尺寸定得在各个相邻对的链段之间有间隙。从而装置70的整个链状结构可以挠性地形变并且扭曲,很象微螺圈,以在动脉瘤中通过上述方法布置时形成网状团块40。在希望刚性化装置70时,在其上通以电流,通过电蚀引起球76在凹窝74中融合。电流可以经布置管16施加,前提是,布置管16(包括夹持元件24)是用导电的金属制造的,带有适当的电极(未示)把栓塞形成装置70连接到电流源(未示)。
第三个实施例的一个修改例示于图13。栓塞形成装置70′是链状结构的,含有多个相互连接的金属链环或者说链段72′,各在其一端有一个凹窝74′并且在另一端有一个开槽的球76′。球76′容纳在凹窝74′中,如上所述。此修改含有一个围绕在各个链段72′的凹窝74′的环形套筒78。套筒78轴向地伸离球76′去紧靠,或者至少紧密地邻接于,下一个相邻的链段72′。套筒78由聚合转变材料形成,在装置70′插入到动脉瘤中时,它初始是软的、柔顺的状态,然后,在填充瘤后,以前述的方式转变成其刚性或者半刚性的状态。因为套筒78,在刚性化时,形成相邻的链段72′之间的相互连接的元件,套筒78的材料的转变刚性化整个装置79′。通过图14的修改的栓塞形成装置70″可以达到类似的效果,但是节省一些成本,图14中,仅交替的链段72′设有套筒78。
图15和16表示第三个实施例的又一个修改。在此修改中,栓塞形成装置70是高度柔顺的链状结构,含有多个互相连接的链环或者说链段72″,它们每个都是空心的。各个链段72"有一个开槽的、磨菇状的头部80,和一个凹窝部82,后者形状和尺寸定得能容纳相邻链段72″的头部80。空心的链段72"使栓塞形成装置70在希望时能够通过一个引导线(未示)插入进动脉瘤。一旦插入了装置70",就注射一种在可流动状态的转变材料84(图16),进入装置70的空心的内部,然后可以完成装置70"从软的柔顺状态转变成其刚性或者半刚性的状态,如以上所述。变通地,链段72″可以用金属制造,然后通过电蚀融合在一起,如前所述。
为选择转变材料,用于根据本发明以相对地软的、半刚性的状态填充动脉瘤,如前所述,并且在其后硬化以充分刚性的状态填充动脉瘤,本领域的一般技术人员可以参见美国专利5,634,936中说明的自硬化聚合材料,其说明在此引用为参考。一般地说,在此参考文献中所说明的材料是这样的聚合体,它们由于适宜地添加交叉链接剂和/或者交叉链接催化剂,在经导管引入时是半刚性的状态,并且只有当它们放置进动脉瘤后才硬化。美国专利5,725,568中所说明的材料也可以选用于本发明,所以,美国专利5,725,568也在此引作参考。
现在用于本发明的优选的材料指定为一种微晶体蜡制合剂,它是大致的半刚性的稠度的,高于体温几度,但是在冷却到体温时变得有足够的刚性。如所公知,一般地说蜡是有12个以上碳原子的脂肪酸并且是直的烷基链。微晶体的蜡材料用当前的技术易于配制成有适宜的转变温度。
现在用于本发明的优选的另外一种材料是醋酸纤维素聚合物,它用乳酸乙酯或者二甲亚砜(DMSO)增塑剂软化。另一个现在优选的材料是一类聚氨基甲酸乙酯基的共聚体,它们可以从Thermedics公司购到,商标为TECOPHILIC。这种共聚物的商业标称是HP-60D-60,SP-80A-150和SP-93A-100。这些聚氨基甲酸乙酯基的共聚物用一种增塑剂或者几种增塑剂的混合物软化,增塑剂主要选自DMSO、乙醇及乳酸乙酯,以DMSO最适用于HP-60D-60,乙醇或乳酸乙酯或者其混合物最适用于SP-80A-150和SP-93A-100。上述的增塑剂有足够的水溶性,从而在聚合材料和增塑剂的紧密混合物放置在动脉瘤中以后,血液的渗透作用把增塑剂逐步地淘汰出聚合材料,以使之刚性化。
一种很适用于图7至图10的微螺圈栓塞形成装置50′和50″的转变材料及图15和16的栓塞形成装置70的转变材料84的合剂是氰丙烯酸酯。氰丙烯酸酯在与渗入到链段72"之间的栓塞形成装置70中的血液接触时通过聚合作用刚性化。
除了以上所述之外,几种生物适应性聚合物和共聚物,诸如乙烯乙烯醇共聚物、聚碳酸氨基甲酸乙酯共聚物和水凝胶,可以和DMSO之类的足量生物适应性增塑剂一起配制,使之成为半刚性的适用于本发明的前文所述的经导管的应用。此后由于通过血液的作用去除增塑剂,这些材料在动脉瘤中充分地硬化。
尽管上面说明了几个优选实施例以及几个变型和修改例,但是对本领域的一般技术人员而言,显而易见,还可以有其它的变型和修改。我们认为这样的变型和修改在所附权利要求书中制定的本发明的精神和范围之内。
Claims (34)
1.一种经有轴向空腔的微导管布置的血管栓塞装置,包含:
一根挠性的细长空心布置管,此管尺寸定得可以适于经所述微导管的空腔插入,此布置管有一个近端和一个远端;和
一个丝状的栓塞形成装置,它的近端可松脱地附着在所述布置管的远端,所述栓塞形成装置可以从软的、柔顺的状态可控制地转变成刚性或者半刚性的状态。
2.权利要求1所述的装置,其特征在于,所述栓塞形成装置包括一种聚合材料,它可以从软的、柔顺的状态可控制地转变成刚性或者半刚性的状态。
3.权利要求2所述的装置,其特征在于,所述聚合材料可以通过与血管血液接触而转变。
4.权利要求2所述的装置,其特征在于,所述聚合材料可以通过与一种比血管的血液冷的生物适应性液体接触而转变。
5.权利要求3所述的装置,其特征在于,所述聚合材料与可溶于血管血液的生物适应性增塑剂混合。
6.权利要求3所述的装置,其特征在于,所述聚合材料包括一种微晶体蜡的合剂。
7.权利要求5所述的装置,其特征在于,所述聚合材料选自醋酸纤维素聚合物和聚氨基甲酸乙酯基的共聚物。
8.权利要求5所述的装置,其特征在于,所述增塑剂选自二甲亚砜、乳酸乙酯和乙醇。
9.权利要求2至8任何一项所述的装置,其特征在于,所述的栓塞形成装置含有连续的压塑聚合材料。
10.权利要求3所述的装置,其特征在于,所述的栓塞形成装置含有一细长的挠性微螺圈,所述微螺圈具有含聚合材料的空心内部。
11.权利要求2至8任何一项所述的装置,其特征在于,所述的栓塞形成装置含有一细长的、挠性的、由多个相互链接的链段构成的链,至少其中的一些包括由聚合材料制造的相互链接部分。
12.权利要求1所述的装置,其特征在于,所述的栓塞形成装置含有一种细长的、挠性的、由多个相互链接的金属链段构成的链,其中所述的链通过电蚀可转变。
13.权利要求3所述的装置,其特征在于,所述的栓塞形成装置含有一种细长的、挠性的、由多个相互链接的空心链段构成的链,空心链段用聚合材料填充。
14.权利要求10或13所述的装置,其特征在于,所述聚合材料是氰丙烯酸酯。
15.一种血管栓塞形成装置,含有:一个细长的丝状元件,它可以从软的、柔顺的状态可控制地转变成刚性的或者半刚性的状态。
16.权利要求15所述的装置,其特征在于,所述装置包括一个聚合材料形成的部分,它可以从软的、柔顺的状态可控制地转变成刚性的或者半刚性的状态。
17.权利要求16所述的装置,其特征在于,所述聚合材料可以通过与血管血液接触而转变。
18.权利要求16所述的装置,其特征在于,所述聚合材料可以通过与一种比血管血液冷的生物适应性液体接触而转变。
19.权利要求17所述的装置,其特征在于,所述聚合材料与可溶于血管血液的生物适应性增塑剂混合。
20.权利要求17所述的装置,其特征在于,所述聚合材料包括一种微晶体蜡合剂。
21.权利要求19所述的装置,其特征在于,所述聚合材料选自醋酸纤维素聚合物和聚氨基甲酸乙酯基的共聚物。
22.权利要求21所述的装置,其特征在于,所述增塑剂选自二甲亚砜、乳酸乙酯和乙醇。
23.权利要求16至22任何一项所述的装置,其特征在于,所述的丝状元件有连续的压塑聚合材料。
24.权利要求17所述的装置,其特征在于,所述的丝状元件含有一细长的、挠性的微螺圈,所述微螺圈具有含聚合材料的空心内部。
25.权利要求16至22任何一项所述的装置,其特征在于,所述的丝状元件含有一细长的、挠性的、由多个相互链接的链段组成的链,至少其中的一些包括由聚合材料制造的相互链接部分。
26.权利要求15所述的装置,其特征在于,所述的丝状元件含有一细长的、挠性的、由多个相互链接的金属链段组成的链,其中所述的链通过电蚀可转变。
27.权利要求17所述的装置,其特征在于,所述的丝状元件含有一细长的、挠性的、由多个相互链接的空心链段组成的链,空心链段用聚合材料填充。
28.权利要求24或者27所述的装置,其特征在于,所述聚合材料是氰丙烯酸酯。
29.一种栓塞血管地点的方法,含有步骤:
(a)布置一根导管使其远端邻接血管地点;
(b)提供一个细长的的丝状栓塞形成装置,它可以从软的、柔顺的状态可控制地转变成刚性的或者半刚性的状态;
(c)经所述导管布置所述栓塞形成装置并且布置到血管地点中,使所述栓塞形成装置在血管地点形成网状的团块;和
(d)把所述的栓塞形成装置从软的、柔顺的状态转变成刚性的或者半刚性的状态。
30.权利要求29所述的方法,其特征在于,所述栓塞形成装置有一个近端和一个远端,并且布置的步骤包含步骤:
(c)(1)提供一个有一个远端的细长挠性布置管;
(c)(2)把所述栓塞形成装置的近端附着在所述布置管的远端;
(c)(3)把所述布置管的远端插入到所述导管中;
(c)(4)在流经所述导管的液体的帮助下推进所述布置管穿过所述导管,以经过导管输送布置管和栓塞形成装置,直到把栓塞形成装置布置进血管地点内;和
(c)(5)把栓塞形成装置从布置管脱离。
31.权利要求29或30所述的方法,其特征在于,所述栓塞形成装置包括一个由聚合材料制造的部分,它可以从软的、柔顺的状态转变成刚性的或者半刚性的状态,并且转变的步骤通过把栓塞形成装置的聚合材料部分与血管血液接触完成。
32.权利要求29或30所述的方法,其特征在于,所述栓塞形成装置包括一个由聚合材料制造的部分,它可以从软的、柔顺的状态转变成刚性的或者半刚性的状态,并且转变的步骤通过把栓塞形成装置的聚合材料部分与比血管血液冷的生物适应性的液体接触而完成。
33.权利要求29或30所述的方法,其特征在于,所述栓塞形成装置包括一个细长的挠性的、由多个相互链接的金属链段组成的链,转变的步骤通过电蚀所述的链段完成。
34.权利要求29或30所述的方法,其特征在于,所述栓塞形成装置有一个空心的内部,并且所述的转变步骤包括步骤:
(d)(1)把转变材料注射进所述栓塞形成装置的内部,所述转变材料可以通过与血管血液接触从流态转变成刚性的或者半刚性的状态;和
(d)(2)把所述转变材料通过与血管血液接触而从流态转变成刚性的或者半刚性的状态。
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