CN1252258A - 包含可膨胀气囊的固定模 - Google Patents
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Abstract
本发明提供安置在管状器官、血管或其它管状体腔内用的固定模。此种固定模包括一个用弹性材料制成的固定模主体,该固定模主体的特征是一个有自由直径的圆筒形。该固定模主体至少部分覆盖一覆盖层,当固定模主体置于一个比自由直径小的直径内时,该覆盖层基本上防止固定模主体向着其自由直径膨胀。在一个实施例中,该覆盖层是一个在固定模主体上的金属涂层。在另一个实施例中,该覆盖层是围绕固定模主体的一个管子或多个管子。也提供一种将本发明的固定模安置在管状器官、血管或其它管状体腔内的方法。
Description
本发明涉及可移植的医学器件,涉及有覆盖层的用弹性或超弹性材料制成的可以移植的固定模。
固定模是移植在管状器官、血管或其它管状体腔中帮助这些导管保持张开的支承结构。固定模常常跟随气囊血管成形术使用,以防止再狭窄,可以更普遍地用于修复许多其它管状体腔中的任何一种,如血管的、胆囊的、生殖泌尿器的、胃肠的、呼吸的和其它系统中的管状体腔。
用于制造固定模的材料必须是对活体组织化学和生物惰性的。固定模必须能继续停留在位置中和长时间地继续支承使它们移植于其中的管状体腔。而且,固定模必须能从一个易于插入体腔的收缩状态膨胀到一个膨胀半径,该膨胀半径能有效地支承至少一部分体腔。这种膨胀的实现或者是利用机械方法,如通过端部有气囊的导管,或者是利用自身膨胀,如通过形状记忆效应或利用一个受限制的弹性固定模。
上述要求限制合适的固定模材料。最广泛使用的金属合金系统之一是镍钛系统,其合金被称为镍钛诺(nitinal)。在某些条件下,镍钛金属互化物是高弹性的,因此它能承受范围广泛的变形而还能返回其初始形状。弹性固定模安置在体腔中的方法通常是,通过机械手段缩小固定模的直径,在插入体内期间将固定模限制在缩小的直径,在目标位置处从限制状态释放固定模。一旦释放,固定模由于其弹性而“自动膨胀”到其预定的有效半径。弹性固定模的优点之一是,在安置后,在受外力变形后它们能“弹回”到其有效直径。此种固定模的弹性不仅使它们在送到目标位置时对自动膨胀是理想的,而且也使它们适用于体腔中,这些体腔常常遭受外力和相应的暂时减小直径或其它变形。例如,弹性固定模对安置在颈动脉中是有效的,颈动脉常由于外力而变形,因为血管紧靠身体表面。
但是,常规的弹性固定模伴随某些潜在缺点。例如,此种自动膨胀的固定模具有单一的预定直径,因此限制使用一个给定的固定模,并增加为覆盖有效直径范围所需的不同固定模数目。在预定直径大于置入固定模的体腔的场合,残余的膨胀力常常造成周围体腔的不需要的逐渐膨胀。自动膨胀的固定模的释放常常不能施加足够的力来张开含有严重病患的堵塞的体腔。因此有时候需要进行将一气囊插入部分地安置的固定模中以进一步扩张的附加步骤,从而对整个步骤增加费用、时间和风险。
本发明提供用于在管状器官、血管或其它体腔中安置的固定模。此种固定模包括一个用弹性材料制成的固定模主体,该固定模主体的特征是有一自由直径的自由圆筒形状。该固定模主体至少部分包含覆盖层,当固定模主体置于一个比自由直径小的直径中时,该覆盖层基本上防止固定模主体向着其自由直径膨胀。此外,在固定模膨胀后,该覆盖层并不迫使固定模主体到一个比它膨胀到的直径更小的直径。在一个实施例中,该覆盖层是一个固定模主体上的金属涂层。在另一实施例中,该覆盖层是一个围绕固定模主体的管子。在又一实施例中,该覆盖层包括围绕固定模主体的多个环。
本发明也提供用于将本发明的固定模安置在管状器官、血管或其它管状体腔中的方法。该方法包括的步骤有:提供一个包括用弹性材料制成的固定模主体的固定模,该固定模主体的特征是具有自由直径的自由圆筒形;使固定模变形到一个小于其自身直径的直径;给固定模覆盖一个覆盖层,当固定模主体置于一个比自由直径小的直径内时,该覆盖层基本上防止固定模主体由于其弹性而向着自由直径膨胀;当位于减小的直径中时将固定模插入体中;并用机械方法膨胀固定模。在一个实施例中,覆盖固定模的步骤包括给固定模主体加涂层的步骤。在另一个实施例中,覆盖固定模的步骤包括将一个管子安置在固定模上的步骤。在又一个实施例中,覆盖固定模的步骤包括将多个环安置在固定模上的步骤。
本发明的一个优点是,它提供等温地安置在体内的固定模。
本发明的另一优点是,它提供抵抗由周围管状器官施加的负荷的固定模。
本发明的另一优点是,它提供膨胀的固定模,这些固定模沿其纵向和径向轴线可以回弹和有弹性,因此当暴露于纵向力和径向力时能抵抗变形。
本发明的又一优点是,它提供通过气囊导管膨胀到受控制的所要尺寸的固定模,而每个固定模可以膨胀到范围广泛的直径中的任何直径。
图1A和1B分别表示本发明的一个实施例的平面图和截面图,其中一个固定模覆盖有金属涂层;
图2表示本发明的一个实施例,其中一个固定模包含管子;
图3表示本发明的一个实施例,其中固定模周围安置了多个环;
图4A至4C表示一种根据本发明将一固定模安置在体腔中的方法的截面图。
本发明利用普通弹性固定模的优点,同时将此类固定模的潜在限制和缺点减到最小。例如,本发明的固定模不限于预定的“已知”直径,不需要与安置阶段隔开的放置后扩张手续。而且,本发明的固定模每个可以膨胀到一个有效直径的范围。此外,当在体腔内目标位置上膨胀到有效直径时,本发明的固定模是弹性的,因此,在接受暂时减小直径或导致其它变形的外力之后,它能重新弹回其膨胀的直径。
通常,本发明的固定模包括一个由弹性材料组成的固定模主体和一个在该主体上的覆盖层。当固定模主体安置在某些较小的直径内时,该覆盖层基本上防止固定模主体向着其自由直径膨胀。将本发明的固定模安置在体腔内的方法是,将固定模的直径改变到小于其自由直径,用一覆盖层覆盖固定模以基本上防止固定模由于其弹性而膨胀到其自由直径,将固定模插入体腔内,而后例如通过气囊膨胀使固定模用机械方法膨胀到体腔内目标位置上一个所要的有效直径。
根据图1A中所示的本发明的一个实施例,固定模100的主体110具有自由直径d的自由圆筒形。当固定模主体110不受外力作用时,其圆筒形和直径d称为“自由的”。虽然固定模100为有图案的管子形式,但其它合适的固定模构型(如线圈、编带、六面体、网、螺旋带、拉链形、拱形固定模等)也在本发明的范围内。
固定模主体110用弹性材料做成,该弹性材料能够在施加外力时遭受显著的可以恢复的(弹性)变形而不产生广泛的永久(塑性)变形。例如,该弹性材料优选的是其特征为可以恢复的应变大于约1%,更优选的是大于约5%。该弹性材料例如是金属材料或聚合物材料。该弹性材料包括所谓“超弹性”材料如某些镍钛金属互化物合金,它们典型的特征是可恢复应变大于约8%。镍钛金属互化物是固定模主体110的优选材料。
因为固定模主体110是用弹性材料做成的,所以它在受外力变形或压缩后往往弹回其自由构型和自由直径。但是,固定模100在其主体110上包括一个覆盖层,当其被放置在比其自由直径小的直径内时,该覆盖层能基本上防止固定模主体110向其自由直径膨胀。其次,该覆盖层将固定模主体110保持到它一旦置于体内目标位置时膨胀到的直径。因此,根据本发明,固定模可以膨胀到的有用直径不需要基本上等于固定模主体110的自由直径。
在一个实施例中,固定模主体110上的覆盖层是最好由塑性可变形金属构成的涂层102。涂层102任选地包括一种X射线吸收材料,因而使固定模100成为射线不透过的。涂层102的优选材料包括金、钩、钯和钽。
涂层102通过适当的方法如浸渍、喷涂、汽相沉积、化学或电化学电镀、溅射等。一种将涂层102涂敷在固定模主体110上的优选方法是电镀。涂层102在固定模主体110上涂敷到厚度t(102),固定模主体110的支柱特征为厚度t(101),如图1B的截面图所示。固定模主体110用涂层102部分地覆盖或全部覆盖。当固定模100的直径例如由于卷曲在气囊导管上而减小时,涂层102的厚度t(102)足以提供使固定模主体110保持在该减小的直径上所需的强度,从而减轻固定模主体110由于其弹性而膨胀到其自由直径d的倾向。例如,当涂层102由挠性软金属如金构成而固定模主体110由镍钛金属互化物构成时,涂层102的厚度最好与固定模主体支柱的截面厚度相近。相反,当涂层102由强度更大的金属构成时,其厚度不需要像下面的固定模主体支柱一样厚。
涂层102将所需性能给予固定模100。例如,当有涂层的固定模100在体内膨胀时,其压缩阻力是固定模主体110的强度和涂层材料的强度的组合,它在固定模100膨胀时塑性变形。因此,固定模100克服其塌陷的径向阻力和安置后的反弹由于涂层102而大大提高。当膨胀后,本发明有涂层的固定模具有沿纵向和径向存在弹性的额外优点,由此阻止纵向力和径向力的永久变形。其次,因为固定模100上增加涂层102显著地防止固定模主体110向其自由直径膨胀,因此,在插入到体中期间,不需要通过外套或其它限制机构来限制固定模膨胀。
图2表示本发明的另一实施例,其中固定模100的主体110用一管子202覆盖,而不是用图1B的实施例中的涂层102覆盖。管子202由任何具有充分强度的适当的生物兼容材料构成,其强度能在固定模主体110置于比自由直径小的直径内后基本上防止固定模主体110向其自由直径膨胀。管子202的一种优选材料是移植级的医用聚氨酯。在图2所示的实施例中,管子202的长度基本上为固定模100的长度。管子202的厚度足以提供将固定模主体110保持在减小的直径所需的强度,从而减轻固定模主体110由于其弹性而膨胀到其自由直径d的倾向。例如,当固定模主体110为镍钛金属互化物而管子202为移植级医用聚氨酯时,管子202的厚度约为100至200微米。
管子202具有潜在的多项功能。例如,在固定模主体110放入一个小于自由直径的直径中以后,管子202防止固定模主体膨胀到其自由直径。其次,因为管子202的长度基本上是固定模主体110的长度,它用于限制通过固定模100的支柱之间的开孔的栓塞形成和生长。作为另一个例子,管子202任选地用于在输送到一个目标位置时保持药剂,随后药剂从管子202释放。例如,管子202中埋有药剂,它们随后在目标位置从管子202释放,以防止或限制新内膜增生。
本发明的另一实施例示于图3中。该实施例与图2中示出的实施例相似,不同之处是,图3中的实施例包括多个管子或环302,每个的长度小于固定模主体110的长度。该实施例比图2中实施例的优选之处是,可以用于希望使用最小覆盖的固定模的用途。
本发明提供将固定模100安置在体腔内的方法。在一个实施例中,该方法包括以下步骤:提供一个包括用弹性材料制成的固定模主体的固定模,该固定模主体的特征是具有自由直径的自由圆筒形;使固定模主体变形到一个小于其自由直径的直径;给固定模覆盖一个覆盖层,该覆盖层基本上防止固定模主体由于其弹性而向着所述自由直径膨胀;将固定模插入主体中;在体腔中目标位置处将固定模用机械方法膨胀到一个所要的有用直径。在固定模插入主体中和置于体腔内目标位置上期间,该覆盖层基本上防止固定模膨胀。其次,在固定模安置后,覆盖层将固定模保持在它膨胀到的直径。因此,本发明的固定模可以膨胀到范围广泛的直径,而不需要使固定模膨胀到的有用直径基本上等于固定模主体的自由直径。
图4A至4C描述一种安置固定模的方法,它们(用截面图)例示固定模在一种血管成形术手续中的安置,作为本发明的一个不起限制作用的例子。如图4A中所示,一个具有固定模主体110和在其支柱上的涂层102的固定模安装在具有可膨胀部分402的导管401上。当安装在导管401上时,固定模的直径小于其自由直径。虽然固定模主体110用弹性材料构成,但涂层102有足够的强度,能基本上防止固定模主体110由于其弹性而向着其自由直径膨胀。导管401安置在一个具有例如由于病患增厚502而产生的堵塞的体腔501中。当插入所要的目标位置时,导管401的可膨胀部分402用已知技术膨胀而将固定模膨胀到所要的有用尺寸,如图4B中所示。在此种膨胀期间,固定模主体110上的金属涂层102遇到塑性变形。导管401的可膨胀部分402随后膨胀到使导管401易于从体腔退出,如图4C中所示。固定模留在膨胀构型的位置中,如图4C中所示。
下面参考不起限制作用的例子进一步描述本发明。
例子1
利用已知技术,用近似组成为51%(原子)镍和余量钛的镍钛金属互化物制成有带图案的管子的固定模。固定模支柱厚约100微米。固定模具有约5毫米的自由直径。固定模利用常规技术用金电镀到约100微米的厚度。固定模然后在室温下变形,而镍钛金属互化物在奥氏体相下到约1毫米的直径。金涂层将固定模保持到约1毫米的直径。
有涂层的固定模卷曲到常规气囊导管的可膨胀部分上。利用已知技术,将气囊导管输送到直径约5毫米的体腔内的一个目标位置上。
当固定模置于目标位置时,气囊导管膨胀到约3至5毫米的直径。在此膨胀期间,固定模同样膨胀到约3至5毫米的直径,而金涂层发生塑性变形而留下来成为完整的涂层。然后气囊导管缩小而从主体内退出,留下膨胀的固定模在目标位置上就位。被安置的固定模由于其奥氏体相和从塑性变形的金涂层产生的附加强度而具有高强度。此外,被安置的固定模具有对反弹和塌陷的极好阻力,而同时保持沿纵向的弹性(即回弹能力)。
例子2
利用已知技术,用近似组成为51%(原子)镍和余量钛的镍钛金属互化物制成有带图案的管子的固定模。固定模支柱厚约100微米。固定模具有约5毫米的自由直径。
固定模在冰水中冷却,将镍钛金属互化物置于奥氏体相并变形,同时冷却到约1毫米的直径。固定模上放置直径约1.5毫米而厚约150微米的聚氨酯管。固定模和聚氨酯管两者均长约1.5厘米。该聚氨酯管将固定模保持到约1毫米的直径。
该有覆盖层的固定模卷曲到常规气囊导管的可膨胀部分上。利用已知技术,将气囊导管输送到直径约5毫米的体腔内的目标位置上。
当固定模安置在目标位置上时,气囊导管膨胀到约3至5毫米的直径。在此膨胀期间,固定模和聚氨酯管两者同样膨胀到约3至5毫米的直径。然后气囊导管缩小而从主体中退出,留下膨胀的固定模和聚氨酯管在目标位置上就位。被安置的固定模由于其奥氏体相和从塑性变形的聚氨酯管产生的附加强度而具有高强度。此外,被安置的固定模具有对反弹和塌陷的极好阻力,而同时保持沿纵向的弹性(即回弹能力)。
本发明提供强度提高的固定模,该固定模等温地安置在主体内而不需限制器。当按照本发明安置时,固定模提供足够的强度来抵抗反弹和塌陷,而保持沿纵向的弹性。该技术的专业人员显然明白,顾及本公开内容,可以做出超过本文具体示范的内容的其它变化。但是,这些变化被认为落入本发明的范围内,只受后随权利要求的限制。
Claims (22)
1.一种用于安置在体腔内的固定模,所述固定模包括:
一个用弹性材料制成的固定模主体,所述固定模主体的特征是一种具有自由直径的自由圆筒形;以及
一个在所述固定模主体上的覆盖层,其中,当所述固定模主体安置在比所述自由直径小的直径内时,所述覆盖层基本上防止所述固定模主体向着所述自由直径的膨胀。
2.按权利要求1所述的固定模,其特征在于,所述弹性材料为镍钛金属互化物。
3.按权利要求2所述的固定模,其特征在于,当安置在所述主体内时,所述镍钛金属互化物处于基本上奥氏体的相中。
4.按权利要求1所述的固定模,其特征在于,所述固定模是一种有带图案的管子的固定模。
5.按权利要求1所述的固定模,其特征在于,所述覆盖层是一种金属涂层。
6.按权利要求5所述的固定模,其特征在于,所述金属涂层的厚度大约等于所述固定模主体的厚度。
7.按权利要求6所述的固定模,其特征在于,所述固定模主体的厚度为大约100微米。
8.按权利要求5所述的固定模,其特征在于,所述金属涂层的金属选自下列一组金属:金、铂、钯、钽及其合金。
9.按权利要求5所述的固定模,其特征在于,所述金属涂层是电镀到所述固定模上的。
10.按权利要求5所述的固定模,其特征在于,所述金属涂层是射线透不过的。
11.按权利要求1所述的固定模,其特征在于,所述覆盖层是一种围绕所述固定模的管子。
12.按权利要求11所述的固定模,其特征在于,所述管子由一种聚合物材料构成。
13.按权利要求12所述的固定模,其特征在于,所述聚合物材料是聚氨酯。
14.按权利要求11所述的固定模,其特征在于,所述管子的长度基本上等于所述固定模的长度。
15.按权利要求11所述的固定模,其特征在于,所述管子的长度大于所述固定模的长度。
16.按权利要求1所述的固定模,其特征在于,所述覆盖层是围绕所述固定模的多个环。
17.一种用于在体腔内安置固定模的方法,所述方法包括下列步骤:
提供一个包括用弹性材料制成的固定模主体的固定模,所述固定模主体的特征是一个具有自由直径的自由圆筒形;
使所述固定模主体变形到一个比所述自由直径小的直径;
在所述固定模主体处于比所述自由直径小的直径时使所述固定模有一个覆盖层,所述覆盖层基本上防止所述固定模主体向着所述自由直径膨胀;
将所述固定模插入体腔内;以及
用机械方法膨胀所述固定模。
18.按权利要求17所述的方法,其特征在于,所述覆盖固定模的步骤包括在所述固定模上电镀一个金属涂层的步骤。
19.按权利要求17所述的方法,其特征在于,所述覆盖固定模的步骤包括将一个聚合物管子安置在所述固定模上的步骤。
20.按权利要求17所述的方法,其特征在于,所述覆盖固定模的步骤包括将多个环安置在所述固定模周围的步骤。
21.按权利要求17所述的方法,还包括在将所述固定模插入体腔内的步骤之前将所述固定模安装在一个气囊导管上的步骤。
22.按权利要求21所述的方法,其特征在于,所述用机械方法膨胀固定模的步骤包括使所述气囊膨胀的步骤。
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