CN1290153A - 血管内修复物 - Google Patents
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Abstract
一种用于治疗动脉瘤、特别是囊状动脉瘤的新的血管内方法。本发明的血管内修复物包括一个叶部,它能被迫紧贴并封闭动脉瘤的开口,从而导致动脉瘤的闭合。该叶部与一体部相连,并能相对于该体部独立移动,该体部包含至少一个可膨胀的部分。因此,该体部的总的作用是将血管内修复物固定在动脉瘤所在附近的靶标机体通道处,叶部起着封闭动脉瘤开口的作用,从而导致动脉瘤闭合。本发明还描述了一种传送和植入血管内修复物的方法。
Description
技术领域
本发明一方面涉及一种血管内修复物。本发明另一个方面涉及一种治疗患者体内动脉瘤的方法。
背景技术
如本领域所知道的,动脉瘤是动脉壁中的异常的隆起性外表。在一些情况下,隆起可能是从动脉全方位向外形成光滑的隆起外表-这称为“梭状动脉瘤”。在其它情况下,隆起可能是从动脉分叉点或动脉一侧产生的囊状形式-这称为“囊状动脉瘤”。
尽管动脉瘤会发生在身体的任何动脉内,但是发生在脑内的那些会导致产生中风。脑内发生的极大多数囊状动脉瘤具有一个颈部,该颈部从脑血管中伸出,并膨胀形成突出于血管的囊泡。
这些动脉瘤引起的问题能以几种不同的方式发生。例如,如果动脉瘤破裂,血液会进入脑或蛛网膜下腔(即紧密围绕脑的腔隙)-后者称为动脉瘤性蛛网膜下出血。这之后会有下列症状中的一种或几种:恶心、呕吐、复视、颈部僵硬和丧失知觉。动脉瘤性蛛网膜下出血是一种急症医学状况,需要立即治疗。实际上,10-15%处该状况的患者在到达医院进行治疗前死亡。高达50%的处该状况的患者会在出血后最初30天内死亡。在存活下来的那些患者中,约有一半将忍受永久性中风的痛苦。通常这种中风会在出血一至二周后由蛛网膜下出血诱导由脑血管痉挛而自行发生。动脉瘤还会引起与出血无关的问题,但这较少见。例如,动脉瘤会在其自身内形成一个血块,该血块会与动脉瘤脱离,向下游传送,因此有堵塞动脉分支引起中风的可能。而且,动脉瘤还会压迫神经(这可能会导致一只眼睛或脸部麻痹或感觉异常)或压迫邻近的脑(这可能会导致癫痫发作)。
由于动脉瘤尤其是脑动脉瘤潜在的致命后果,本领域提出采用各种方法来治疗动脉瘤。
总地来说,动脉瘤可以从血管外部用外科技术来治疗,或从血管内部用血管内技术来治疗(后者在介入(即非外科)技术的宽的标题下)。
外科技术通常涉及颅骨切开术,该方法需要在患者颅骨中产生一个开口,通过这个开口,外科医师能伸入仪器直接在脑上作手术。在一个方法中,牵开脑,暴露形成动脉瘤的血管,然后外科医师横过动脉瘤的颈部置入小夹钳,从而阻止动脉血液进入动脉瘤。如果动脉瘤内有血块,该夹钳还阻止血块进入动脉,从而避免了中风的发生。在正确放置了夹钳后,动脉瘤将在数分钟内闭合。外科技术是动脉瘤最常用的治疗方法。不幸的是,治疗这些病状的外科技术被认为是很大的外科手术,其对患者有高度危险性,而且需要患者强壮以至有机会经该手术后存活。
如上所述,血管内技术是非外科技术,其通常在血管造影室中用导管输送系统来进行。具体地说,已知的血管内技术涉及采用导管输送系统,用阻止动脉血液进入动脉瘤的材料来填充动脉瘤-该技术广义上称为栓塞。这种方法的一个例子是Guglielmi Detachable Coil(可分离绕线),它涉及通过一个系统在动脉瘤内闭塞动脉瘤,该系统采用一个铂绕线与不锈钢输送线和电解分离部分相连接。因此,一旦铂绕线被放入动脉瘤内,它便通过电解质的溶解与不锈钢传输线分开。具体地说,患者的血液以及灌输的盐水起着导电溶液的作用。正极是不锈钢传输线,负极是放在患者腹股沟内的接地针。一旦电流传递通过不锈钢传输线,紧靠铂绕线(铂绕线当然不受电解影响)的不锈钢分离区的非绝缘部分就会发生电解溶解。其它方法涉及使用诸如醋酸纤维素聚合物的材料来填充动脉瘤的囊。尽管这些血管内方法是本领域中的一个进步,但它们仍有缺点。具体地说,这些血管内方法的危险性包括在操作中使动脉瘤破裂或由于装置或动脉瘤血块的远端栓塞而引起中风。另外,用这些技术还关系到消除血管内动脉瘤闭合后的远期结局。具体地说,存在有填充材料在动脉瘤内重新排列的证据,在随后的血管造影术时动脉瘤再现。
一种特定类型的脑动脉瘤已被证实是很难治疗的,尤其是用上述的外科夹钳或血管内栓塞技术来治疗,它发生于远端底部动脉(basilar artery)处。此类动脉瘤是一种易破的外突,通常位于基底动脉的末端分叉点处。要成功治疗此类动脉瘤是非常困难的,至少部分原因是在放置外科用夹钳期间必须不损伤所有脑干穿通血管。
不幸的是,有时动脉瘤的大小、形状和/或位置会使外科夹钳和血管内栓塞技术不能用于特定的患者。一般而言,这些患者的预后是不良的。
因此,尽管现有技术在治疗动脉瘤领域中已经取得进展,但是仍然有待改进之处,尤其是血管内栓塞技术,因为它是大手术的一种有吸引力的替换方案。具体地说,希望有一种血管内修复物,它能用来栓塞用其它方法难以或不能治疗的动脉瘤。还希望这些血管内修复物能用来治疗目前用血管内方法治疗的动脉瘤,同时减少或避免目前的血管内栓塞形成技术所具有的缺点。
发明揭示
本发明的一个目的是提供一种新的血管内修复物,该修复物避免或减少了上述现有技术的至少一个缺点。
本发明的另一个目的是提供一种血管内封闭动脉瘤开口的新方法,该方法避免或减少了上述现有技术的至少一个缺点。
因此,本发明一方面涉及一种用来血管内封闭动脉瘤开口的修复物,该修复物包括:
一个体部,它具有一个近端、一个远端以及位于两者之间的至少一个可膨胀的部分,所述至少一个可膨胀的部分能靠作用于其上的径向向外的力从未膨胀的第一状态膨胀成膨胀的第二状态,以使第一个可膨胀的部分紧贴血管管腔,和
一个与该体部连接的叶部,
该叶部能相对于体部独立移动。
本发明另一方面涉及一种用来血管内封闭动脉瘤的修复物,该修复物包括:
一个体部,它具有一个近端、一个远端以及位于两者之间的至少一个可膨胀的部分,所述至少一个可膨胀的部分能靠作用于其上的径向向外的力从未膨胀的第一状态膨胀成膨胀的第二状态,以使第一个可膨胀的部分紧贴血管管腔,和
一个与该体部连接的叶部,
该体部在以下两个状态之间变动:(ⅰ)第一个状态是近端、远端和叶部沿体部纵轴对齐,和(ⅱ)第二个状态是叶部只与远端和近端中的一个沿纵轴对齐。
本发明另一方面涉及一种用来血管内封闭动脉瘤开口的修复物,该修复物包括:
一个具有纵轴的体部,它包含至少一个可膨胀的部分,所述至少一个可膨胀的部分能靠作用于其上的径向向外的力从未膨胀的第一状态膨胀成膨胀的第二状态,以使第一个可膨胀的部分紧贴血管管腔,和
一个与该体部连接的叶部,
该体部在以下两个状态之间变动:(ⅰ)第一个状态是至少一个可膨胀部分与叶部沿该纵轴对齐,和(ⅱ)第二个状态是至少一个可膨胀部分与叶部沿该纵轴不对齐。
本发明另一方面涉及一种用一种修复物来血管内封闭动脉瘤开口的方法,该修复物包括:一个体部,该体部具有一个近端、一个远端和位于它们之间的至少一个可膨胀的部分;以及与该体部相连的一个叶部,该方法包括下列步骤:
将修复物放置在一个导管上;
通过机体通道的导管插入术将修复物和导管一起插入机体通道内;
将修复物和导管移动到动脉瘤开口所在的靶标机体通道;
将径向向外膨胀的力作用于至少一个可膨胀部分上,使得至少一个可膨胀的部分紧贴靶标机体通道,
迫使叶部紧贴动脉瘤开口,从而封闭动脉瘤开口。
因此,本发明者已经发现了一种新的血管内方法可用来封闭动脉瘤开口,尤其是囊状动脉瘤中的开口,导致动脉瘤闭合。该方法是真实的血管内方法,因为通过本发明的血管内修复物,不需要用一种材料(如Guglielmi可拆卸绕线(detachable coil)中所用的材料)来填充动脉瘤囊。相反,本发明的血管内修复物运作的根据是,它起封闭动脉瘤囊开口的作用,从而避免采用填充材料。因此,发现了一种避免或减少现有技术中许多缺点的新的血管内修复物。本发明的血管内修复物包含一个叶部,该叶部能紧贴动脉瘤开口,从而闭合动脉瘤。该叶部与包含至少一个可膨胀部分的体部相连接,并且能相对于该体部独立地移动。管状部分能靠作用于其上的径向向外的力从未膨胀的第一状态膨胀成膨胀的第二状态,以迫使第一个可膨胀的部分紧贴血管管腔。因此,体部起的作用大致是将血管内修复物固定在动脉瘤开口所在附近的靶标血管管腔机体通道处,叶部起的作用是密封动脉瘤开口,从而闭合动脉瘤。因此,如下文进一步的展开描述,叶部起作用,并且能独立于血管内修复物的体部移动。
较佳的,并且如下文进一步展开描述的那样,至少一个可膨胀部分通常的结构呈管状。实际上,在整篇说明书中,所提及的可膨胀部分通常是管状的结构。然而,这些引证只起描述的目的,本领域技术人员会认识到,可以用非管状的结构(例如在膨胀时打开的爪形设计)作为至少一个可膨胀的部分。
本发明的血管内修复物的体部具有一个大致的纵轴,该体部是灵活的。叶部可以相对于膨胀或非膨胀的体部在至少第一状态和第二状态之间独立地移动。因此,在第一位置中,体部的远端和近端沿叶部对齐。在第二个状态中,在固定体部的远端和近端的同时,叶部维持一定程度的独立移动。通过这种方式,叶部可相对于体部“独立移动”。在一个实施例中,较佳的是,该独立移动是通过放置叶部使其相对于血管内修复物的其余部分旋转来实现的。应当理解,尽管叶部能相对于体部独立移动,但远端、近端和叶部的最终对齐(在封闭动脉瘤开口后的对齐)没有特定的限制,这取决于诸如动脉瘤的大小和位置以及特定患者的解剖学等因素。关键点在于叶部能相对于体部独立移动。
在一个较佳的实例中,体部呈软管形式,较佳的是柔软的有孔的管。在该实例中,叶部可能是沿管长度的一个剪开物,管子的至少一端、较佳的是两端可在其上施加了径向向外的力之后膨胀,从而将管子固定在靶标机体通道中。叶部能在管子弯曲和/或管子膨胀时在径向向外的方向上移出管平面,被迫紧贴动脉瘤的开口,从而封闭动脉瘤的开口。
在另一个较佳的实例中,体部的形式成一对相互连接的相对的管状或环状的部分。叶部与管状或环状的部分之一或两者相连。环状的部分能在其上施加了径向向外的力(例如通过导管固定的气囊施加或自身膨胀装置固有的力)时膨胀,以迫使体部固定在靶标机体通道中。如本领域中所知道的,可以通过将这些部分设计成具有多孔表面(例如含有许多相互连接的支柱),来赋予环状部分可膨胀性。对于诸如不锈钢的材料,这使环状结构在到达塑性变形点之前膨胀。叶部能在管子弯曲和/或管子膨胀时在径向向外方向上移出管平面。
据认为本发明的血管内修复物为上文所述的常规外科技术提供了一种有意义的备选方案。而且,预计本发明的血管内修复物能用来治疗某些经诊断认为不能进行手术的动脉瘤。还认为本发明的血管内修复物提供了目前的血管内方法(如上文所述的Guglielmi Detachable Coil)所具有的有意义的优点。具体地说,由于本发明的血管内修复物不用将金属填充材料(例如铂绕线)插入动脉瘤,因此减小了破坏动脉瘤的危险性,从而减小了金属填充材料的动脉瘤间重排以及随后的动脉瘤的再现的危险。
附图简述
下面将参照附图描述本发明的实例,其中相同的参考数字意味着相同的元件,其中:
图1-5描述了基底动脉末端分支点的部分剖面透视图,其中正在输送和植入本发明血管内修复物的第一个实例;
图6描述了图1-5所述的本发明血管内修复物第一个实例之改进的放大图;
图7描述了图1-5所述的本发明血管内修复物第一个实例之另一改进的放大图;
图8-10描述了本发明血管内修复物的叶部形状的各种实例;
图11描述了本发明血管内修复物的第二个实例的透视图;
图12-15描述了基底动脉末端分支点的部分剖面透视图,其中正在输送和植入图11所示的实例;
图16描述了本发明血管内修复物的第三个实例的透视图;
图17-18描述了基底动脉末端分支点的部分剖面透视图,其中正在输送和植入图16所示的实例;
图19描述了图16-18所示的本发明血管内修复物的实例之改进的放大图;
图20-22示意性地描述了本发明血管内修复物的较佳实例的透视图;
图23描述了图20-22所示血管内修复物所包括的一个实例的二维放大透视图;和
图24描述了图20-22所示血管内修复物所包括的另一实例的二维放大透视图。
实施发明的最佳方式
参看图1-5,下面将具体参照将同一血管内修复物植入基底动脉末端分支点来描述本发明血管内修复物的第一个实例。
图中描述了基底动脉10,它末端在接合点15分叉成一对次级动脉20、25。动脉瘤30位于接合点15处。动脉瘤30有一个开口35(仅出于描述目的而放大显示),血液通过该开口进入并维持动脉瘤30。
将血管内修复物100固定在导管50上。
导管50包括可充气的气囊55和一条导引金属丝60。导管50、可充气的气囊55和导引金属丝60是常规的的。如本领域所知道的,可充气的气囊55能沿导引金属丝60移动。
血管内修复物100由体部105构成。体部105包括一个近端110和一个远端115。血管内修复物100还包括一个与体部105相连的叶部120。如图所示,叶部包括颈部125和头部130。头部130比颈部125宽。在所述的实例中,叶部120的头部130背向远端115(叶部120的头部130朝向近端110)。
体部105是大致成管状的元件,它应制成充分地柔软,使得它能被操纵到达靶标机体通道,并且具有充分的可膨胀性,从而使它能固定在靶标机体通道中的合适位置处。
实现这点的一种方法是构造结构类似于内支架(stent)的结构制造血管内修复物100。如本领域所知道的,内支架是一种可膨胀的修复物,它通常用来获得和维持机体通道(例如血管、呼吸道、胃肠道等)的开放。内支架的两个总体设计要求是:(ⅰ)它在未膨胀状态下必须足够柔软,从而使其能完整地被操纵导引至靶标机体通道,和(ⅱ)在膨胀的状态下,它必须具有足够的径向刚性,以避免产生再狭窄和/或内支架回弹。本发明的血管内修复物本身不是一种内支架,因为它不需要满足设计要求(ⅱ)-即本发明血管内修复物的目的不是维持被封闭的机体通道的开放。相反,为了将修复物固定在正确的位置,本发明的血管内修复物包括一个或多个可膨胀的元件。
因此,在该方法中,体部105可能是一个多孔的管,它具有由众多相交的部分来限定的多孔性(为了清楚起见,图1-5中没有示出体部105的多孔性)。相交部分的确切方式没有特别的限制,其选择应能使多孔管在未膨胀的状态下具有足够的柔软性,同时具有靠管上径向向外的力来实现至少一定程度膨胀的可能性。通常,多个相交部分的排列确定了规则的重复的图案。例如参见,下列待批专利申请中公开了各种重复的图案:
加拿大专利申请号2,134,997(1994年11月3日提交);
加拿大专利申请号2,171,047(1996年3月5日提交);
加拿大专利申请号2,175,722(1996年5月3日提交);
加拿大专利申请号2,185,740(1996年9月17日提交);
加拿大专利申请号2,192,520(1996年12月10日提交);
国际专利申请PCT/CA97/00151(1997年3月5日提交);
国际专利申请PCT/CA97/00152(1997年3月5日提交);和
国际专利申请PCT/CA97/00294(1997年5月2日提交);
这些申请每一份的内容以及其中引用的参考文献均纳入本文作参考(后文总称为“Divysio专利申请”)。尽管Divysio专利申请中公开的重复图案适用于内支架的设计,但是也可对它们进行改进,以提高用于本发明血管内修复物的管状结构的弯曲性(例如通过改变Divysio专利申请中提出的多边形设计),即使得到的管子可能不能用作内支架。
体部105可以用任何合适的材料构成。在一个较佳的实例中,体部105由塑性可变形的材料(如金属、合金或聚合物)构成。合适的金属和合金的非限制性例子可以选自:不锈钢、钛、钽等。在该实例中,用来膨胀体部105的径向向外的力可以通过导管固定的气囊的膨胀来施加,这在下文有更详细的讨论。在另一个较佳的实例中,体部105由能在至少约30℃的温度下、较佳的在约30-40℃范围内自身膨胀的“形状记忆”金属合金(如镍钛诺)制成。在该实例中,可以理解当体部105暴露于处于程控自身膨胀温度的环境下时,体部105固有的径向向外的力使其膨胀。在还有一个较佳的实例中,体部105可以由生物可降解的材料制成。如本领域所知道的,生物可降解的材料在长期接触体液后会发生降解,因此可用于本发明的血管内修复物,因为动脉瘤会在动脉瘤开口闭合后数分钟内闭合。
体部105的生产方式没有特别的限制。较佳的,体部105用施加在管状原料上的激光切割技术来生产。因此,原料可以是如上所述的金属、合金或聚合物的薄管,然后从其中切去部分,留下所需的上述重复模式。然后,采用这种技术,可用激光加工成叶部120的颈部125和头部130的轮廓,就可简单地产生叶部120。
另外,还可以从一条或多条预先成形的金属丝来制造具有所需多孔重复图案的体部105。在另一个备选实例中,可以用平床激光(flat bed laser)切割技术,任选地与焊接技术组合,来制造具有所需多孔重复图案的体部105。
由于血管内修复物100起封闭朝向动脉瘤30之开口35的作用,因此重要的是要相应地设计叶部120。具体地说,应这样设计叶部120,使得它能封闭朝向动脉瘤30的开口35。这可以多种方式来实现。在一个实例中,将叶部120的头部130设计成无孔的。在另一个实例中,将叶部120的头部130设计成是多孔的(例如为了便于生产体部105),然后用合适的无孔涂层材料覆盖。无孔涂层材料可以有活性(例如药剂、胶粘剂等,起无孔表面的作用并具有额外的优点)或没有活性(例如一种惰性的涂层材料,其唯一的目的是提供无孔的表面)。在还有一个实例中,叶部120的整个表面(即颈部125和头部130的总和)的最初设计可以是无孔的,或者最初是有孔的,随后用一无孔涂层覆盖。
血管内修复物100上还可包含一种涂层材料。该涂层材料可以连续地或不连续地涂布在修复物表面上。另外,涂层可以涂布在修复物的内表面和/或外表面上。涂层材料可以是一种或多种生物惰性材料(例如来减少修复物的形成血栓性)、一种在植入后渗入机体通道壁的药物组合物(例如提供抗凝血作用,向机体通道输送药物等)等。
血管内修复物100宜具有一种生物相容的涂层,以便最大程度地减小与机体血管壁和/或通过血管流动的体液(通常是血液)的不利的相互作用。该涂层宜为一种聚合物材料,它通常是通过向修复物提供一种溶剂配制的预先形成的聚合物溶液或分散液然后除去该溶剂来提供的。另外也可采用非聚合物的涂层材料。合适的涂层材料,例如聚合物,可以是聚四氟乙烯或硅氧烷橡胶、或已知具有生物相容性的聚氨基甲酸酯。然而,较佳的聚合物宜具有两性离子悬垂基团,它通常是磷酸铵酯基团,例如磷酸胆碱基团或其类似物。合适聚合物的例子在国际申请WO-A-93/16479和WO-A-93/15775中有所描述。那些说明书中描述的聚合物是与血相容的且通常是生物相容的,而且是光滑的。重要的是修复物的表面被完全涂覆,以便最大程度地减小不利的(例如与血的)相互作用(该相互作用可能会在来源血管中导致形成血栓)。
良好的涂层可以通过适当地选择涂层条件(如涂层溶液的粘度、涂覆技术和/或溶剂除去步骤)来获得。
参看图1,一旦需要植入血管内修复物100,就将其固定在导管50的气囊55上。然后以箭头A的方向将导管50移动通过基底动脉10。
参看图2,用常规的导引金属丝和X光透视技术,将固定在导管50的气囊55上的血管内修复物100导引至动脉瘤30所在位置。在所描述的实例中,体部105的远端115进入次级动脉20。在实践中,基底动脉分支处的次级动脉是不对称的,体部105的远端115导引进入两个次级动脉中较大的一个。另外,在所述的实例中,当体部105在弯折进入次级动脉20时,叶部120上升或移动至与体部105的管状平面不成一直线,从而确定了开口135。
参看图3和4,一旦当血管内修复物100位于正确的位置,气囊55膨胀,从而对体部105施加径向向外的力。开始时,这导致体部105膨胀从而使其一部分紧贴基底动脉10和次级动脉20的壁。参看图4,随着气囊55继续膨胀,一部分气囊55压迫在叶部120的颈部125和头部130上,从而迫使叶部120紧贴次级动脉20,25的管壁,结果导致封闭动脉瘤30的开口35。
参看图5,气囊55放气,将气囊和导引金属丝60一起沿箭头B的方向从血管内修复物100中抽出。在所述的实例中,血管内修复物100通过体部105紧紧压迫在基底动脉10和次级动脉20的壁上而固定在位置上。另外,在所述的实例中,叶部120靠箭头C方向上的血液流动对其施加的力以及体部105至导引进入次级动脉20的远端115弯曲开口固有的力的组合来固定。一旦叶部120封闭了开口35,随后动脉瘤就会闭合。
图6描述了图1-5所述血管内修复物之改进方案的放大视图。在图6中,相同的数字用来代表图1-5中相同的元件,图6中的改进的或新的元件用后缀“a”表示。具体地说,叶部120a已经过改进,使得颈部125a由不导电的材料制成,而头部130a由导电材料制成。另外,在头部130a的动脉瘤侧放置了药学上可接受的胶粘剂132a,并且将一根定位金属丝140a固定在头部130a的连接点145a处。在使用时,可用定位金属丝140a来确定叶部120a的方向,从而使头部130a正确地闭合动脉瘤30的开口35。一旦叶部120a位于正确的位置,就使电流通过定位金属丝140a,从而使其与头部130a在连接点145a上分开。另外,根据胶粘剂132a的特征,通过定位金属丝140a的电流可起激活胶粘剂132a的附加的作用。当然,也可以改进图6所示的具体实例,例如:(ⅰ)省略胶粘剂132a,因而电流起着将头部130a密封到开口35周围的作用;(ⅱ)省略定位金属丝140a,从而通过胶粘剂132a实现头部130a与开口周围的封合;或(ⅲ)用相同材料(导电的或不导电的)制造头部130a,因而定位金属丝140a的主要目的是使叶部120a对齐。
图1-6所述实例的一种较佳的改进涉及将定位金属丝140a改进成图1-5所示导引金属丝60的辅助(或第二根)导引金属丝。具体地说,当导引金属丝60导引进入次级动脉20时,辅助导引金属丝可通过叶部的开口(例如靠近图6中连接点145a的位置)并在血管内修复物植入时进入次级动脉25。通过以这种方式使辅助导引金属丝通过叶部,将大大促进修复物的输送,重要的是,能加强对叶部封合动脉瘤开口的方向的控制。
图7中描述了图1-5所述血管内修复物的另一种改进方案。在图7中,用相同的数字代表图1-5中相同的元件,图7中改进的或新的元件用后缀“b”表示。具体地说,对叶部120b进行改进,使头部130b的动脉瘤侧涂覆了药学上可接受的可膨胀的化合物132b。在使用时,一旦当叶部120b的取向使得头部130b正确闭合了动脉瘤30的开口35,可膨胀的化合物132b就与体液发生化学反应,膨胀成膨胀的化合物134b并填充了动脉瘤。或者,可膨胀的化合物132b可以用如图6所述的定位金属丝来电激活。
图8-10描述了叶部之头部形状的各种改进方案。在图8-10中,相同的数字用来代表图1-5中相同的元件,图8-10中的改进的元件分别用后缀“c”,“d”和“e”来表示。对于本领域技术人员显而易见的是,图8-10中分别描述的头部130c、130d或130e可以从体部105中切出或与其重叠。
图11描述了血管内修复物200形状的本发明的第二个实例。血管内修复物200由体部205构成。体部205包括一个近端210和一个远端215。血管内修复物200还包括一个与体部205相连的叶部220。如图所示,叶部220包括一个颈部225和一个头部230。头部230比颈部225宽。在所述的实例中,叶部220的头部230背向远端215(即,叶部220的头部230朝向近端210)。
体部205还包括一对环235、240,它们由一对金属丝245、250相互连接。在所述的实例中,叶部220与环235相连。金属丝245、250的位置宜赋予修复物200足够的完整性,同时提供最大程度的弯曲性,以提供增强的导引作用。金属丝245、250的目的是将环235和240相互连接起来,同时使得修复物200具有足够的弯曲性(从而使其能导引至靶标机体通道),且具有足够的可膨胀性(这样它就能固定在靶标机体通道的合适位置处)。在修复物200膨胀期间(即修复物200处于正确位置这一时点之后),金属丝245、250并非是特别重要的。另外,本领域技术人员显然能看出,叶部220能相对于修复物200的近端210和远端215独立移动(在所述的实例中,叶部220能相对于环235、240独立移动)。
参看图12-15,将修复物200固定在导管50上,并参照上文图1-5所述方式进行输送和植入。在该实例中,较佳的是以这样的方式植入修复物200:使金属丝245、250毗邻基底动脉10和次级20(在所述实例中)。
本发明的这一实例可用来描述本发明的血管内修复物与常规的内支架之间的差别。具体地说,在本发明的实例中,可膨胀的元件是环235、240。环235、240包括相互连接的支柱的多孔结构,为了清楚起见,在该图中没有描绘出该结构。相互连接的支柱的多孔结构的确切特征没有特定限制,这是本领域技术人员力所能及的。膨胀环235、240的主要作用是将修复物200固定在位置上,且不必改变通过其中有环发生膨胀的动脉部分的血流-即这是内支架的目的。
图16描述了血管内修复物300形状的本发明第三个实例。血管内修复物300由体部305构成。体部305包括一个近端310和一个远端315。血管内修复物300还包括一个与体部305相连的叶部320。体部305包括一对环335和340,它们通过一对金属丝345和350相互连接。同样,环335、340包括一个相互连接的支柱的多孔结构,为了清楚起见,该图中没有描述该结构。相互连接的支柱的多孔结构的确切特征没有特别限制,这是本领域技术人员力所能及的。如图所示,叶部320通过一对金属丝322和324与环335和340相连。另外,金属丝345、350的每一个各自含有一对波浪形的部分355,金属丝322和324的每一个各自含有一个波浪形的部分355。波浪形部分355改进了修复物300的弯曲性和导引性。
同样,金属丝322、324、345和350的尺寸宜赋予修复物300足够的完整性,同时最大程度地提高弯曲性以提供增强的导引作用。金属丝345、350的目的是与环335、340相互连接,同时使修复物300具有足够的弯曲性(这样它能导引至靶标机体通道)且具有足够的可膨胀性(这样它能固定在靶标机体通道的合适位置上)。在修复物300膨胀期间(即修复物300处于正确位置这一时点后),金属丝345、350并不是特别重要的。金属丝322、324的目的是使叶部230相对于修复物300的近端310(在所述实例中这将包括环335)和远端315(在所述实例中这将包括环340)更为独立的移动。参看图17-18,将修复物300固定在导管50上,并参照上文图1-5所述方式进行输送和植入。进一步参看图18,本领域技术人员会理解,为了获得最优的效果,金属丝322、324、345和350在环335、340上的位置应使得金属丝324在血管内修复物植入后不越过次级动脉25。
图19描述了图16-18所示血管内修复物的一种改进方案。在图19中,相同的数字用来表示图16-18中相同的元件,图19中新的元件用后缀“f”表示。在图19中,加入了波浪形金属丝326f来连接叶部320和金属丝345、350。另外,叶部320和环340之间没有相互连接的金属丝。在该实例中,省略了叶部320和环340之间的相互连接的金属丝,从而避免血管内修复物植入后连金属丝越过次级动脉25的管腔,同时,波浪形金属丝326f的加入改善了修复物的物理完整性。
图20-22描述了怎样从管状原料中切下血管内修复物400的各个元件(同样,为了清楚起见,图20-22中没有描述修复物400的具体的孔隙以及气囊导管输送系统)。
血管内修复物400由体部405构成。体部405包括一个近端410和一个远端415。血管内修复物400还包括一个与体部405相连的叶部420。如图所示,叶部420包括用来封闭动脉瘤开口35的封闭部425。在所述的实例中,叶部420的自由端背向远端415(即叶部420的自由端朝向近端410)。
体部405还包括一对可膨胀的管状部分435、440,它们通过一根脊450相互连接。在所述的实例中,叶部420与管状部分435相连。脊450的尺寸宜赋予修复物400足够的完整性,同时最大程度地提高弯曲性以增强导引性。脊450的目的是使管状部分435、440相互连接,同时使修复物400具有足够的弯曲性,这样修复物就能导引至靶标机体通道。对于本领域技术人员显而易见的是,叶部420能相对于修复物400的近端410和远端415独立移动(在所述的实例中,叶部420能相对于管状部分435、440独立移动)。
图23描述了可膨胀的修复物400的一个实例的二维图形。在所述的实例中,封闭部分425包括一系列大致纵向的蜿蜒的支柱426、427、428,它们独立地在一端与管状部分435连接,相反的一端通过一个横向的支柱429来相互连接。
支柱426、427、428、429产生的多孔结构上覆盖了一种材料,该材料适合(ⅰ)抵抗修复物400的膨胀,和(ⅱ)在展开后封闭动脉瘤30的开口35。用于此目的的材料的性质没有特定限制。较佳的,该材料包含Cardiothane 51TM(Kontron Instruments,IncEverett,Massachusetts)、一种已知用于血管内器械的医药级聚氨基甲酸酯/硅氧烷聚合物(如用于主动脉内心脏辅助器械的气囊材料)。因此,“裸露的”封闭部分425最初可用5.7%重量:体积(w∶v)的有机溶剂(例如2∶1的四氢呋喃:1,4-二噁烷)配制的Cardiothane 51TM溶液来涂覆。然后可以用溶于相同溶剂的Cardiothane 51TM溶液(11.7%w∶v)再涂覆最初涂覆的封闭部分425。聚合物变干后,将封闭部分的支柱基本上包埋在聚氨基甲酸酯-硅氧烷覆盖层内。然后用环氧乙烷对有覆盖层的封闭部分425进行消毒。关于该方法的更多信息,参见Okoshi等人的“多孔的对有皮层的聚氨基甲酸酯-聚二甲硅氧烷小直径血管移植物的体内评价”,ASAIO Transactions 1991;37:M480-M481,该文内容纳入本文作参考。
图24描述了一个可膨胀修复物400例子的二维图象。在所述的例子中,封闭部分425包括与管状部分435连接点475相连的翼片470。如图所示,翼片470的一部分含有一系列紧密分布的细微切口480。细微切口480的尺寸、数目和位置的选择是本领域技术人员力所能及的,其选择用来优化翼片470的弯曲性,同时限制了体液通过的孔隙度。
不超出本发明范围和精神的上述具体实例的其它变化和改进对于阅读了本说明书的本领域技术人员来说是显而易见的。例如,尽管在各个所述的实例中,显示出叶部在输送时朝向修复物的近端,但这不是必需的,在一些情况下,相反的取向可能是较佳的。另外,在所述的各种实例中,叶部包括一个头部和一个颈部,但颈部并非在所有情况下都必须存在。还有,在所述的各种实例中,显示了一对可膨胀的环形环,但也可用单个可膨胀的锚固手段(例如环形环等)或3个或多个可膨胀的锚固手段(如环形环等)来构成修复物。再有,在所述的各种实例中,叶部基本上是细长的,与修复物的纵轴平行放置,但也可以这样放置该叶部:使其与修复物的纵轴垂直。更有,在所述的各种实例中,体部的可膨胀部分包括一对具有多孔结构的环,但是也可以采用具有无孔结构的环,将环向下折,用可移动的机械约束力维持它们处于该状态,除去该约束后,使环展开成展开状态(在该实例中,选择环尺寸为其最终植入的直径,然后向下折叠-例如参见WO-A-95/26695,其内容纳入本文作参考)。不脱离本发明精神和范围的其它改进对于本领域技术人员来说在阅读了本说明书之后是显而易见的。
Claims (28)
1.一种用于血管内封闭动脉瘤开口的修复物,该修复物包括:
一个体部,它具有一个近端、一个远端以及位于这两者之间的至少一个可膨胀的部分,所述至少一个可膨胀的部分能靠作用于其上的径向向外的力从未膨胀的第一状态膨胀成膨胀的第二状态,以使第一个可膨胀的部分紧贴血管管腔,和
一个与该体部连接的叶部,
该叶部能相对于体部独立移动。
2.根据权利要求1所述的修复物,其中该叶部包括一个基本上无孔的部分。
3.根据权利要求1至2任一项所述的修复物,其中至少一个可膨胀的部分是有孔的。
4.根据权利要求1至2任一项所述的修复物,其中该体部包括至少一对相对的可膨胀的部分。
5.根据权利要求4所述的修复物,其中相对的可膨胀的部分通过连接装置相互连接。
6.根据权利要求4所述的修复物,其中相对的可膨胀的部分通过至少一根金属丝相互连接。
7.根据权利要求4至6任一项所述的修复物,其中该叶部与相对的可膨胀部分中的一个相连接。
8.根据权利要求4至7任一项所述的修复物,其中相对的可膨胀部分包括一个有孔的表面。
9.根据权利要求5至8任一项所述的修复物,其中相对的可膨胀部分、连接装置和叶部是整体形成的。
10.根据权利要求1至9任一项所述的修复物,其中该体部是管子。
11.根据权利要求1至9任一项所述的修复物,其中该体部是有孔的管子。
12.根据权利要求10至11任一项所述的修复物,其中管子由塑性可变形的材料制成。
13.根据权利要求10至11任一项所述的修复物,其中管子由自身膨胀的材料制成。
14.根据权利要求10至11任一项所述的修复物,其中叶部是从管子的切出部,以在第二位置中确定体部的开口。
15.根据权利要求1至14任一项所述的修复物,其中该叶部包括一个头部。
16.根据权利要求15所述的修复物,其中该叶部包括一个将头部和体部相互连接起来的颈部。
17.根据权利要求16所述的修复物,其中该头部比颈部宽。
18.根据权利要求1至17任一项所述的修复物,其中叶部的表面上还包含药学上可接受的胶粘剂。
19.根据权利要求1至18任一项所述的修复物,其中叶部还包括调节叶部相对于体部之位置的调节装置。
20.根据权利要求19所述的修复物,其中该调节装置包括与叶部相连接的金属丝。
21.根据权利要求20所述的修复物,其中该金属丝与叶部上的一点相连接,该点在叶部与体部相连的点的远端。
22.根据权利要求1至21任一项所述的修复物,其中叶部还包括能膨胀并进入动脉瘤开口的药学上可接受的化合物。
23.根据权利要求22所述的修复物,其中该药学上可接受的化合物在受激活后膨胀。
24.根据权利要求22所述的修复物,其中该药学上可接受的化合物在电激活后膨胀。
25.根据权利要求1至24任一项所述的修复物中,其中叶部包括一个用来接收将修复物导引至靶标位置的导引装置的孔。
26.一种用来血管内封闭动脉瘤的修复物,该修复物包括:
一个体部,它具有一个近端、一个远端以及位于两者之间的至少一个可膨胀的部分,所述至少一个可膨胀的部分能靠作用于其上的径向向外的力从未膨胀的第一状态膨胀成膨胀的第二状态,以使第一个可膨胀的部分紧贴血管管腔,和
一个与该体部连接的叶部,
该体部在以下两个状态之间变动:(ⅰ)第一个状态是近端、远端和叶部沿体部纵轴对齐,和(ⅱ)第二个状态是叶部只与远端和近端中的一个沿纵轴对齐。
27.一种用来血管内封闭动脉瘤开口的修复物,该修复物包括:
一个具有纵轴的体部,它包含至少一个可膨胀的部分,所述至少一个可膨胀的部分能靠作用于其上的径向向外的力从未膨胀的第一状态膨胀成膨胀的第二状态,以使第一个可膨胀的部分紧贴血管管腔,和
一个与该体部连接的叶部,
该体部在以下两个状态之间变动:(ⅰ)第一个状态是至少一个可膨胀部分与叶部沿该纵轴对齐,和(ⅱ)第二个状态是至少一个可膨胀部分与叶部沿该纵轴不对齐。
28.一种用修复物来血管内封闭动脉瘤开口的方法,该修复物包括:一个体部,该体部具有一个近端、一个远端和位于它们之间的至少一个可膨胀的部分;以及与该体部相连的一个叶部,该方法包括下列步骤:
将修复物放置在导管上;
通过机体通道的导管插入术将修复物和导管插入机体通道内;
将修复物和导管移动到动脉瘤开口所在的靶标机体通道;
将径向向外的膨胀力作用于至少一个可膨胀部分上,迫使至少一个可膨胀部分紧贴靶标机体通道,
迫使叶部紧贴动脉瘤开口,从而封闭动脉瘤开口。
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US7452198P | 1998-02-12 | 1998-02-12 | |
US60/074,521 | 1998-02-12 |
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AT (1) | ATE313304T1 (zh) |
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- 1999-02-12 WO PCT/CA1999/000100 patent/WO1999040873A1/en active IP Right Grant
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CN106963515B (zh) * | 2017-02-24 | 2018-12-18 | 上海长海医院 | 一种主动脉覆膜支架 |
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DE69929036T2 (de) | 2006-08-31 |
CA2320868C (en) | 2008-08-12 |
US6669717B2 (en) | 2003-12-30 |
DE69929036D1 (en) | 2006-01-26 |
AU2406599A (en) | 1999-08-30 |
US6261305B1 (en) | 2001-07-17 |
ATE313304T1 (de) | 2006-01-15 |
US20020013618A1 (en) | 2002-01-31 |
JP2002502664A (ja) | 2002-01-29 |
CA2320868A1 (en) | 1999-08-19 |
CN1177570C (zh) | 2004-12-01 |
EP1054647A1 (en) | 2000-11-29 |
WO1999040873A1 (en) | 1999-08-19 |
US20020026232A1 (en) | 2002-02-28 |
JP4204752B2 (ja) | 2009-01-07 |
AU754966B2 (en) | 2002-11-28 |
EP1054647B1 (en) | 2005-12-21 |
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