CN1596088A - 血管内动脉瘤修复系统 - Google Patents
血管内动脉瘤修复系统 Download PDFInfo
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Abstract
在体腔内植入可径向膨胀的假体(14)的方法和装置依赖于用分开引入的固着器(28)固定或锚着假体。所述的假体可以是自行膨胀的或者是可气囊膨胀的。在初始置位后,在膨胀了的假体内引入固着器施放器系统(27)以在至少一个假体末端,通常是在假体的每个末端,布设多个固着器。固着器通常是从固着器施放器中的螺旋形轨迹通过用旋转器线转动发放的螺旋形固着器。所述固着器将被单个地施放,典型地是以绕假体每个末端的内部以圆周地间隔开的图案施放。
Description
本申请要求2001年11月28日提交的在审美国临时申请60/333,937号的优先权。
技术领域
本发明一般涉及把血管假体附着于天然血管,并且特别地涉及用于修复罹病和/或损伤了的血管段的方法和装置系统。
技术背景
由受损伤或者罹病而削弱血管壁可以导致血管扩张并且形成血管瘤。如不加治疗,血管瘤的大小可增长并且将最终破裂。
例如,主动脉血管瘤主要地发生在腹动脉区域,一般地在肾动脉与主动脉叉之间的肾下区域。动脉瘤也可发生在主动脉弓和肾动脉之间的胸部区域。主动脉瘤破裂可造成大出血并且致死率高。
开放手术更换罹病的或者损伤的血管段可以降低血管破裂的风险。在该手术中,切除罹病的或者损伤的血管段并且安装或以直的构形或以分杈的构形制造的假体移植物,然后用缝线永久地附着和密封在天然血管的末端上。这些手术用的假体移植物一般地是无支持的编织管并且典型地用聚合物,ePTFE或者其它适当的材料制造。所述移植物纵向无支持从而它们可以适应血管瘤和天然血管的形态上的改变。然而,这些手术需要大的手术切口并且致病率和死亡率高。另外,许多患者由于其它复合发病(co morbidity)而不适于这种类型的大手术。
引入了血管内动脉瘤修复以克服与开放手术修复相关联的问题。动脉瘤用血管腔内安置的血管假体搭桥。典型地,这些动脉血管瘤假体移植物缩瘪地用导管经股动脉发放。这些移植物一般地设计有附着在金属的支架(斯腾氏支架)结构的纤维材料,所述的金属支架膨胀或者被膨胀以接触血管的内径。与开放手术动脉瘤修复不同,血管腔内布设的移植物不缝合在天然血管上,而是依赖于从支架伸出的在布设过程中穿入天然血管内的倒钩,或用支架本身的径向膨胀力把移植物固定在位。与缝合比较时,这些移植物附着手段不提供相同的附着力度,并且可能在布设时损伤天然血管。
因此,有这样的血管内动脉瘤修复系统的需要,所述的血管内动脉瘤修复系统首先提供可以适应血管瘤的形态改变并且可以不损伤天然血管地布设的假体移植物,其次提供对血管壁永久性移植物附着的分开的血管内固附系统。
发明内容
说明了用于在体腔内植入可径向膨胀的假体的方法和装置。特别地,本发明提供植入进血管的血管支架和支架移植物的改进方法和系统,所述血管既包括动脉也包括静脉。在示例的实施方案中,支架移植物置于血管中以加强动脉瘤,尤其是腹主动脉血管瘤。
在本发明的第一方面,通过首先在体腔内的植入位置处或附近,例如在血管瘤一侧的维管结构处或者附近,膨胀至少一个假体的支架。在膨胀假体的支架后,经假体向支架区域内引入多个固着器以把支架锚着在位。所述支架可以是弹性的,典型地含有形状记忆性合金弹性不锈钢等。对于弹性支架,膨胀典型地包括从约束释放支架以让支架能够在植入位置自行膨胀。所述约束可以是径向的约束,即,管状导管、发放鞘或者类似物置于支架上以保持支架在径向缩小的构形。膨胀通过在导管鞘上回拉以让支架恢复其较大直径的构形而得以实现。此外,支架可以被约束成轴向伸长的构形,例如通过把支架的任一端附着在内管、杆、导管或类似物上,以保持支架于伸长的、直径缩小的构形。然后支架从这样的轴长约束释放以让它自行膨胀。
或者,支架可以用有展性的材料,例如有展性的不锈钢或者其它金属制造。然后膨胀可以含有在支架内施加径向膨胀力以引起膨胀,例如在支架一侧内充胀支架发放导管以造成膨胀。
血管假体可以有各种各样的常规构形。在优选的血管支架移植物的安置中,假体典型地含有由支架支持的纤维等血液半透的挠性屏障,所述支架典型地为斯滕氏支架(stent)的构形。斯滕氏支架可具有任何常规的斯滕氏构形,譬如之字形、S形,膨胀的菱形,或者其组合。支架结构可以延伸移植物的整个长度,在一些情况下可以较移植物的纤维成分长。或者,支架将只覆盖假体的一小部分,出现在1、2或者3个末端。在配置用于治疗分杈的血管区域,譬如治疗腹主动脉血管瘤,支架移植物伸入进髂总动脉中时,斯滕氏支架可有三个或者更多的末端。在某些情况下,支架可以沿支架移植物的整个长度或者至少在其整个长度的大部分上间隔开,在此单独支架结构不相互直接连接,而是连接在移植物的纤维成分或者其它的挠性成分上。
引入固着器典型地在初始安置了假体以后进行。该初始安置通过自行膨胀或者气囊膨胀进行,其后通过引入多个单独的固着器把假体固定或者说锚着在位,所述的固着器优选地是被旋转从而“螺丝旋入”假体和血管壁中的螺旋形固着器。固着器可以只经纤维布置,即避开支架结构。或者,固着器可以被引入和通过支架结构的部分,选择地通过已专门配置用于容纳固着器的插口或者缝隙。在某些情况下,当然,固着器将被既经纤维也经支架结构上方引入。
在示例的实施方案中,固着器是螺旋的固着器,它们被单个地,即一次一个地,在假体的内壁上以圆周间隔开的图案引入。通常,使用承载单个固着器的固着器施放器引入固着器。承载单个固着器的固着器施放器比承载多个固着器的固着器施放器有较小的轮廓并且可更有效及较少损伤性。然而,可以构想在某些实施方案中固着器施放器也可承载多个固着器。而且,固着器施放器可以以上述优选的圆周间隔开的空间图案同时布设多个固着器。通常,在要锚着的假体的每个末端施放2-12个固着器。该2-12个固着器通常将被施放在单个圆周间隔开的行中,所述的固着器可以施放在一个以上的行中,同时单独固着器被轴向地对齐或者圆周地交错开。在一个优选的实施方案中,本发明的腔内固着器施放器含有一个引导部件和一个施放器部件,所述的引导部件,例如,含有具有可偏转的远端尖端的管状体,和选配地,用于保持可偏转的尖端对着要施放固着器的移植物中位置的稳定器。施放器部件可以经引导部件的空腔插入并且承载至少一个单个螺旋形的或者其它的固着器。设有旋转装置用于转动和推进螺旋形的固着器从而使之穿入移植物和下面的血管壁以把移植物牢固地锚着在位。
附图说明
本发明将参照附图从下列详细说明的本发明实施方案中得以理解。在附图中:
图1是血管内移植物发放装置的一个实施方案的透视图,图示其置于腹动脉血管瘤内;
图2是在图1的动脉瘤内布设血管内移植物的一个实施方案的透视图;
图3是完全布设的图2的直的血管内移植物的透视图;
图4是完全布设的分杈的血管内移植物的透视图,剖开以示在一端锚着支架。
图5是与图5相似的透视图,示出替代的支架结构;
图6是透视图示出用于引导固着器施放器的装置的一个实施方案;
图7是透视图示出图6的装置在图3布设的血管内移植物内插入以后,移植物和支架都被剖开。
图8是图6的装置的透视图,示出附着于引导装置的稳定装置的一个实施方案的起动;
图9是铰接在图6所示的引导装置上的图8所示的控制组件的透视图。
图10是图8所示的稳定装置的替代实施方案的透视图;
图11是透视图示出图10的替代稳定装置的起动;
图12是透视图示出图8所示的稳定装置的另一个实施方案;
图13是透视图,示出图12的稳定装置的起动;
图14是固着器施放器的一个实施方案;
图15是图14的固着器施放器置于图6所示的引导装置内的透视图;
图16是图14的固着器施放器一个实施方案的放大的截面图;
图17是附着施放器放大的截面图,示出螺旋形固着器的近端和驱动机构的一个实施方案;
图18是图16所示的螺旋形固着器的一个实施方案的放大的透视图;
图19是附着施放器的放大视图,示出致动固着器施放器的控制组件的一个实施方案;
图20是用植入进移植物和血管壁的固着器致动施加的附着的放大图;
图21示出完成了的图3的近端移植物用固着器附着于血管壁的放大图;
图22是完全地附着于血管的图4所示的移植物的透视图。
具体实施方式
图1描述了在引导线12置于腹主动脉血管瘤11内的血管内移植物发放导管10。图2描述在血管内布设移植物的初始阶段。发放导管10具有在移植物上的可移动的罩13。当近端地拉所述罩时,移植物14膨胀以接触血管的内壁。移植物可以构想是自行膨胀的或者使用膨胀构件,譬如气囊或者机械的膨胀体。继续移植物布设过程直到移植物完全地被布设到血管内。移植物可以构想是直的也可以是分杈形状的。图3示出完全布设了的直的移植物14,而图4描述完全布设了的分杈的移植物15。引导线11用于发放和定位移植物,保留在血管内以通达固着器附着系统。移植物支架16(斯腃氏支架)的一个实施方案以图4的局部剖视的方式示出。所述的支架是以简单的之字形图案的形式,然而支架的设计可以构想涉及如图5中所示的更加复杂的图案17。尽管在图4和5中只示出移植物内的一个支架结构,在移植物中可以构想加入多个独立的支架结构。
图6描述了引导装置18的一个实施方案,带有置于引导装置的空腔内并且伸过引导装置的远端尖端的闭塞件19。所述的闭塞件具有一个空腔使之可以通过引导线发放。图7示出引导装置经引导线12在布设了的血管内移植物内部被定位。引导装置有合并的稳定装置20以帮助保持引导装置在血管内的位置。在一个实施方案中,稳定装置20是弹簧加载的并且被定位用在取走引导装置中的闭塞件时,参阅图8。引导装置通过如图8所示的控制组件21致动。在一个实施方案中,控制组件21以可移动轮或者杠杆22为特征,所述的可移动轮或者杠杆22把引导装置18的远端尖端23偏转到所希望的位置,如图9中所示。本发明设想引导装置的控制组件可以被机械地、电气地、液压地或者气动地致动。所述的控制组件具有穿通的空腔以让闭塞件和固着器施放器能够通过。图10描述了作为可移动的支柱组件24的稳定装置的另一个实施方案。可移动的支柱组件经图11所示的控制组件上的杠杆25致动。在两个实施方案(图7和10)中,稳定装置都在引导装置的远端。在另一个实施方案中,稳定装置可以是邻近于引导装置的远端尖端的可膨胀的构件的形式,参阅图12。在一个实施方案中,可膨胀的构件26示出经控制组件上的杠杆25致动,参阅图13。然而,还可以构想这种稳定装置感觉可以是被充胀的。在所有的实施方案中,稳定装置都可以用于稳定引导构件,在血管内不论是同心还是偏心。
在本发明的另一个实施方案中,可以使用分开的管状装置与引导装置配合以通达血管。这种分开的管状装置可以合并用在引导装置上方的稳定装置。
图14描述出固着器施放器27的一个实施方案。图14A是固着器施放器的远端的详图。图15描述出固着器施放器经引导装置的空腔被定位在将安装固着器的地方。
图16示出固着器施放器27和引导装置18的放大的截面图。在固着器施放器的一个实施方案中,螺旋形固着器28通过连接到控制组件31的驱动杆30经固着器驱动器29被转动。驱动杆30可以用使之既能弯曲也能够转动的任何材料制造。驱动杆连接在固着器驱动器29上,后者接合螺旋的固着器并且向之传递力矩。图16示出与固着器施放器内的内沟槽32接合的螺旋形固着器28的线圈。可以构想,所述的沟槽沿固着器的整个长度或者在其长度的部分之内被定位。图17是固着器施放器27的放大的截面图,以固着器驱动器29的截面示出固着器驱动器和螺旋的固着器28之间接合的一个实施方案。在该实施方案中,形成螺旋形固着器的近端线圈以产生跨越螺旋形固着器的直径的对角构件33。类似的螺旋形固着器说明于美国专利5,964,772;5,824,008;5,582,616和6,296,656中,其公开内容全部引作参照。
图18描述螺旋形固着器28的一个实施方案,示出对角构件33。图19描述固着器施放器27的一个实施方案在固着器施放器控制组件的致动过程中。所述控制组件的致动转动驱动杆、固着器驱动器和螺旋形固着器。该旋转引起螺旋形固着器28在固着器施放器的内沟槽32中移行并且进入移植物14和血管壁34中,参阅图20。固着器施放器的控制组件可以构想被机械地、电气地、液压地或者气动地致动。
图21示出完成了的螺旋形固着器28把移植物14附着在血管壁34上。可以构想,需要提供一或多个固着器把移植物牢靠地附着在血管壁上。
图22示出近端和远端都附着在血管壁上的移植物假体的透视图。本发明可以构想用于在主动脉和其它的分枝血管内进行直的和分杈的移植物15的移植物附着。
可以理解本文说明的优选实施方案的成分和/或特征可以一起地或者分开地使用,同时所描述的方法和装置可以整体或者部分地被组合或修改。可以构想,引导装置、固着器施放器和螺旋形固着器可以交替地相互相对取向,例如偏移、双轴等等。而且,应当理解可以使用本文没有说明的其他过程之外的各种实施方案,譬如血管创伤、动脉切开、人工心脏瓣膜附着和在血管系统内和一般地说在体内其它假体的附着。
以上详细描述了本发明的实施方案,以提出完整的公开内容并且为了解释和阐明的缘故。本领域内普通技术人员可设想其它在本公开内容的范畴和精神内的其它修改。
Claims (19)
1.在体腔内植入可径向膨胀的假体的方法,所述的方法含有:
在体腔内的植入部位膨胀至少一个假体的支架;和
经假体向支架的区域内引入多个固着器以把支架锚着在位。
2.如权利要求1所述的方法,其中所述支架是弹性的,并且膨胀包含从约束释放支架以让支架能够在植入部位自行膨胀。
3.如权利要求1所述的方法,其中支架是有展性的,并且膨胀包含在支架内施加径向膨胀力以引起膨胀。
4.如权利要求1所述的方法,其中膨胀包含在假体上间隔开的位置至少膨胀至支架。
5.如权利要求1所述的方法,其中膨胀包含在假体上膨胀至少三个间隔开的假体。
6.如权利要求1所述的方法,其中膨胀包含膨胀跨越在假体的整个长度上的支架结构。
7.如权利要求1所述的方法,其中假体含有覆盖至少一部分支架的纤维,其中引入包含经纤维而不是经支架引入至少一些固着器。
8.如权利要求1所述的方法,其中假体含有覆盖至少一部分支架的纤维,其中引入含有在支架的元件上方引入至少一些固着器。
9.如权利要求1所述的方法,其中固着器是螺旋形穿透固着器。
10.如权利要求9所述的方法,其中引入步骤包含在假体内壁上的圆周间隔开的柱中引入单个固着器。
11.如权利要求10所述的方法,其中引入包含在安置固着器的每个区域引入2至12个螺旋形固着器。
12.腔内固着器施放器,含有:
带有可偏转的远端尖端的管状体;
构形做成接合血管壁以保持所述管状体的远端在位的稳定器;
在所述管状体的近端的控制手柄,其具有控制件以分开地偏转远端,并且布设保持被偏转的远端在位的稳定器;
和用于把固着器从远端推进到由远端接合的血管壁内的器件。
13.如权利要求12所述的腔内固着器施放器,其中固着器推进器件含有固着器发放装置,所述的固着器发放装置可以经管状体引入并且承载至少一个固着器。
14.如权利要求13所述的腔内固着器施放器,其中所述固着器发放装置含有挠性杆,所述的挠性杆在其远端承载单个螺旋形固着器,以及含有用于旋转和推进螺旋形固着器穿透组织的器件。
15.如权利要求14所述的腔内固着器,其中所述的挠性杆具有螺旋形轨迹,所述螺旋形轨迹承载螺旋形固着器,和具有接合并且转动螺旋形固着器以引起从身体远端推进的旋转器线。
16.在体腔内目标部位植入可径向膨胀的假体的方法,所述的方法含有:
从远端的入口部位向目标部位推进引导线;
通过引导线向目标部位引入假体布设导管;
在目标部位从布设导管布设假体;
通过引导线把布设导管交换成腔内固着器施放器;和
从腔内固着器施放器经假体引入多个固着器以锚着假体。
17.如权利要求16所述的方法,其中假体是自行膨胀的,并且布设包含从约束释放假体以让假体能够在目标部位自行膨胀。
18.如权利要求16所述的方法,其中假体是有展性的,并且膨胀含有在假体内施加径向膨胀力以引起膨胀。
19.如权利要求16所述的方法,其中单个固着器从腔内固着器施放器施放,然后从维管系统中撤出施放器,以及在将所述施放器返回目标位置前在导管上加载新的固着器。
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