CN1596087A - 腔内假体附着系统和方法 - Google Patents
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Abstract
本发明公开在体内植入假体的方法和系统。所述的系统和方法提供假体在身体内的永久性附着。所述的假体例如可以含有血管内移植物,它可以布设在动脉或静脉系统中而不损伤天然血管。所述的血管内移植物可以包含例如径向膨胀的血管支架和/或支架移植物。所述的移植物可以被置于维管系统中,例如排除或者搭桥血管瘤,例如腹主动脉血管瘤。移植物有利地适应于血管瘤形态改变并且修复血管内血管瘤。固着系统和方法可以经维管系统布设并且在体外操纵,以发放固着器而把移植物附着在血管壁上。
Description
本申请要求2002年10月15日提交的在审美国专利申请号10/271,334的优先权。本申请还要求2001年11月28日提交的在审美国临时申请号60/333,937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。
发明内容
本发明提供在体内植入假体的系统和方法,所述的系统和方法提供永久性地在体内附着假体。所述的假体可含有,例如,血管内移植物,所述的血管内移植物可以不损伤天然血管地布设在不论是动脉还是静脉系统内。所述的血管内移植物可以含有,例如,可径向膨胀的血管支架和/或支架移植物。所述的移植物可以置于维管系统内,以例如排挤或者搭桥动脉血管瘤,如腹动脉血管瘤。移植物有利地适应于动脉瘤形态的改变并且修复血管内血管瘤。所述的固着系统和方法经维管系统被布设并由体外加以操作,以发放固着器把移植物附着在血管壁上。
本发明的一个方面提供假体的固着器施放器。所述的施放器含有其尺寸和构做成可释放地连接到固着器上以向假体内布设固着器的驱动机构。所述的施放器还包括驱动机构的致动器,所述的驱动机构包括传感器,它使驱动机构的操作能够响应下列至少之一:(i)在固着器处或附近检测的力,和(iii)检测到的在固着器体的远端处或者附近与表面的接触。
本发明的另一个方面提供尺寸和构形做成用于在组织中布设的固着器。所述的固着器包括有用于响应一个力而穿透组织的远端的固着器体部。所述的固着器体还具有用于可释放地把固着器体连接到力施加器上的近端。固着器包括一个与所述近端关联的止挡结构用于防止固着器体过度地穿透进组织。在一个实施方案中,所述的止挡结构把固着器体连接到力施加器,例如通过磁性的或者机械的连接。在一个实施方案中,固着器体可以含有,例如螺旋线圈。
本发明的另一个方面提供尺寸和构形做成用于在组织中布设的固着器。所述的固着器包括有用于响应一个力而穿透组织的远端的固着器体。所述的固着器体还具有用于可释放地把固着器体连接到力施加器上的近端。一条跟踪线连接到所述近端以将力施加器引导成与固着器操作地接触。
本发明的另一个方面提供含有假体体部和由假体体部整体地承载的固着器组件的假体。所述的固着器组件包括至少一个可响应由力施加器施加的力布设进组织中的固着器。一条跟踪线连接到固着器上以把力施加器引导得与固着器操作接触。
本发明的另一个方面提供含有假体体部和由假体体部整体地承载的固着器组件的假体。所述的组件包括至少一个可响应由力施加器施加的非旋转力布设进组织中的固着器。
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14A是图14中所示的固着器施放器远端的放大图,示出固着器驱动机构的细节;
图14B是图14所示的固着器施放器的手柄的内部截面图;
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;
图23是图14所示的固着器施放器的驱动机构的放大的截面图,示出接触/力传感组件,所述的接触/力传感组件在固着器与目标组织之间没有所希望的接触时使所述施放器失灵;
图24是图14所示的固着器施放器的驱动机构的放大的截面图,示出接触/力传感组件,所述的接触/力传感组件使得能够响应所希望的固着器与目标组织之间接触使用所述施放器;
图25A和25B是固着器施放器远端的放大图,示出固着器驱动机构的一个替代的实施方案的细节;
图26A是图25A和25B中所示的固着器施放器的驱动机构的放大的截面图,示出接触/力传感组件,所述的接触/力传感组件在固着器与目标组织区域之间没有所希望的接触时使所述施放器失灵;
图26B和26C是图25A和25B中所示的固着器施放器的驱动机构的放大的截面图,示出接触/力传感组件,所述的接触/力传感组件使得能够响应所希望的固着器与目标组织区域之间接触使用所述施放器;
图27是可以与图14、23和24中所示的固着器施放器联合使用的螺旋形固着器的透视图;
图28A是可以与图25A和25B中所示的固着器施放器联合使用的螺旋形固着器的透视图;
图28B是可以与图26A至26C中所示的固着器施放器联合使用的螺旋形固着器的透视图;
图29是具有成角的施加器末端的固着器施放器的局部剖视的放大的侧视图,所述的固着器施放器可以用于布设图27所示的螺旋形固着器而不使用分开的引导装置;
图30是具有成角的固着器施放器的一个替代实施方案的局部剖视的放大的侧视图,所述的固着器施放器可以用于布设图27所示的螺旋形固着器而不使用分开的引导装置;
图31是具有成角的固着器施放器的另一个替代实施方案的局部剖视的放大的侧视图,所述的固着器施放器可以用于布设图27所示的螺旋形固着器而不使用分开的引导装置,固着器施放器具有铰接的施加器末端;
图32是一个血管内假体的透视图,示出定位在腹主动脉血管瘤中,所述的假体包括一个整体的固着器组件;
图33是图32中所示的血管内假体的透视图,带有用于操作地与整体的固着器组件互动的腔内工具,以暂时地或者永久地把假体锚着在血管壁上;
图34是形成图33中所示的整体的固着器组件的一部件的固着器的侧视图,该固着器具有一个图示为在其与整体的固着器组件结合前一般分开的情形的柄;
图35是图34中所示的固着器的侧视图,此图中该固着器柄以关闭的情形示出并且装在形成整体的固着器组件的一部分的环管内;
图36和37是侧视图,示出图33中所示的腔内工具的使用,以从其在图35所示的位置并且经过血管壁施加力驱动固着器。
图38是在布设把假体锚着在血管壁上以后的整体的固着器组件;
图39是侧视图,示出跟踪线的使用,以把腔内工具引导成与固着器接触,从而可以经血管壁施加力驱动固着器;
图40是假体发放导管的一个实施方案,用于其中支架结构只覆盖假体一部分的假体,所述的导管包括一个稳定柱阵列,用于辅助对抗血液流动把假体保持在位;
图41是假体发放导管的另一个实施方案,用于其中支架结构只覆盖假体一部分的假体,所述的导管包括一个反向的稳定柱阵列,用于辅助对抗血液流动把假体保持在位;以及
图42是假体发放导管的另一个实施方案,用于其中支架结构只覆盖假体一部分的假体,所述的导管包括一个稳定篮筐,用于辅助对抗血液流动把假体保持在位。
发明详述
I.发放假体
图1描述了通过引导线12置于体腔内的血管内移植物发放导管10。导管10承载假体14(参阅图2),所述的假体14安置在目标位置,例如通过假体14的径向膨胀(参阅图3)。在假体14膨胀后,一或多个固着器28(参阅15和16)通过固着器附着组件引入以把假体14锚着在位。
为了展示的目的,图1示出目标位置在腹主动脉血管瘤11内。目标位置可以是体内的任何位置。在所述的安排中,假体14取血管内移植物的形式。
图2描述在目标位置布设移植物的初始阶段。尽管布设的方法可以改变,在所示的实施方案中,发放导管10具有覆盖在移植物14上的可移动的罩13。当近端地拉所述罩13时,移植物14自由地径向膨胀,从而扩张以接触血管的内壁。图示的移植物14是自行膨胀的。此外,移植物14可以使用膨胀构件,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。移植物的大小和构形可以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。
A.假体
移植物14有利地并入支持框,或者说支架16。支架16可以是弹性的,例如含有形状记忆性合金弹性不锈钢,或者类似物。对于弹性支架,膨胀典型地包含从约束释放支架以让支架能够在植入位置自行膨胀。在图示的安排中,罩13起径向约束的作用。或者,管状导管的安放,发放鞘,或者在支架16上的类似物可以起保持支架于径向缩小的构形。在此安排中,支架16的自行膨胀通过在径向约束构件上回拉达到,以让支架16能够采取其较大直径的构形。
此外,支架16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。这保持支架16于伸长的直径缩小的构形。支架16然后可以从这样的轴向约束被释放以能够自行膨胀。
此外,支架16可以形成自有展性的材料,譬如有展性的不锈钢或者其它金属。这样膨胀可以含有在支架内施加径向膨胀力以引起膨胀,例如在支架内充胀支架发放导管以进行膨胀。在此安排中,内移植物的定位和布设可以使用或分开的或合并在布设导管中的膨胀器件完成。这将使得内移植物安置在血管中并部分布设,同时妨碍在血管中的相对位置。此膨胀或经气囊或经机械膨胀装置得以完成。另外,该膨胀通过对抗血液作用在内移植物上的力直至可以完全地布设内移植物而稳定动脉中内移植物的位置。
血管假体14可以有各种各样的常规构形。假体14典型地可以含有由支架16支持的纤维或者某些其它的血液半透的挠性屏障,所述支架可以采取斯滕氏支架(stent)结构的形状。所述斯滕氏支架结构可以有任何常规的支架构形,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,并在一些情况下可以较移植物的纤维成分长。或者,支架结构将只覆盖假体的一小部分,例如出现在末端。在构形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,支架结构可有三个或者更多的末端。在某些情况下,支架结构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。
移植物支架16或者说斯腃氏支架结构的一个示例性实施方案以图4的局部剖视的方式示出。在此,所述的斯腃氏支架结构是以简单的之字形图案的形式,然而可以构想支架的设计可以涉及如图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斯腃氏支架结构,但如前所述,在移植物中可以构想加入多个独立的斯腃氏支架结构。
图40示出假体发放导管600的一个实施方案,用于其中支架结构16只覆盖假体一部分,例如只出现在末端的假体14。如图40中所示,所述的假体发放导管600(图示它通过引导线610被布设)包括一个稳定柱612的阵列,所述的稳定柱612例如通过缝合线在假体14的末端可释放地连接支架结构16,所述的缝合线可以通过拉穿过导管600中的空腔的索引线(未示)被松开。在布设(通过回撤发放鞘614)假体14的其余部分的同时,所述的稳定柱612相对血管壁34保持自行膨胀的支架结构16在位。柱612支持支架结构16(并且从而支持整个假体14)在假体布设时对抗流经血管的血液流动力。导管600还可以包括在其远端的头锥体618以扩散流向血管壁的血液,从而在布设假体14时辅助地支持假体14。在布设假体14以后,可以通过拉索引线松开缝合线从支架结构14上拆下柱612,并且经发放鞘614通过引导线610撤出导管600(从支架结构16上松开以后,柱612在通经发放鞘614的过程中折回在导管600上)
图41是假体发放导管700的另一个实施方案,用于其中支架结构16只覆盖假体一部分,例如只出现在末端的假体14。如图40中所示,假体发放导管700(它在图示中通过引导线710布设)包括一个反向的稳定柱712阵列,所述的反向的稳定柱712例如通过缝合线在假体14的末端可释放地连接支架结构16,所述的缝合线通过拉穿经导管700中的空腔的索引线(未示)被松开。类似于图40中所示,在假体14的其余部分被布设(通过撤回发放鞘714)时,反向的稳定柱712相对血管壁34保持自行膨胀的支架结构16在位。类似于图40中的鞘600,导管700还可以包括在其远端的头锥体718以扩散流向血管壁的血液。在布设假体14以后,可以通过拉索引线(未示)从支架结构14拆下柱712,并且经发放鞘714通过引导线710撤出导管700(从支架结构16上松开以后,柱712在通经发放鞘614的过程中折回在导管600上)。
图42是假体发放导管800的另一个实施方案,用于其中支架结构16只覆盖假体一部分,例如只出现在末端的假体14。如图42中所示,假体发放导管800(它也在图示中通过引导线810布设)包括一个自行膨胀的稳定篮筐812。在假体14的其余部分被布设(通过撤回发放鞘814)时,稳定篮筐812相对血管壁保持自行膨胀的支架结构16在位。类似于图40和41中的鞘600和700,导管800还可以包括在其远端的头锥体818以扩散流向血管壁的血液。在布设假体14以后,可以通过发放鞘814把稳定篮筐812置于松塌的状态,正如通过引导线810撤出导管800。
在所有刚刚说明了的实施方案中,引导线610、710、810可以相继地被用于布设假体14的固着器附着组件,如下文将更加详细说明地那样。
II.固着假体
在一个所需的实施方案中,设有使之可能进行腔内固着器附着的固着器附着组件。可以不同地构成所述的附着组件。
A.两部件固着器引导和附着组件
在一个安排中,固着器附着组件包含固着器引导件或者说引导部件18和固着器施放部件27。引导部件18有利地具有可操纵或者可偏转的远端尖端,所述的远端尖端初始地通过引导线12布设。在使用中,用于发放和定位假体14的引导线12有利地保留在血管内用于随后布设固着器引导部件18。
可选择地,引导部件18包括稳定器,用于在取走引导线12以后,把偏转了的尖端保持在假体14中要施放假体14的固着器28的位置上。
在此安排中,所述的施放部件27有利地通过引导部件18布设。固着器施放器27承载至少一个固着器28和用于推进固着器28的固着器驱动机构100,以使它穿透假体14和下面血管壁,从而牢靠地把假体14锚着在位。
1.固着器引导部件
图6描述了引导装置18的一个实施方案,所述引导装置18形成固着器附着组件的一个部分。部件18采取引导装置18的形式。装置18带有置于引导装置18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19具有一个空腔使得可以通过引导线12发放引导装置18,如图7中所示。
引导装置18有利地包括合并的稳定装置20,以在取走引导线12以后帮助保持引导装置18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闭塞件19和引导线12时进行布设(参阅图8)。
在所示的实施方案(参见图8),引导装置18包括控制组件21。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以常规的方式操作内操纵线,以把引导装置18的远端尖端23偏转到所希望的位置,如图9中所示。可以设想引导装置18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21具有穿通的空腔以让闭塞件19和施放器部件27能够通过。
图10描述了另一实施方案,其中稳定装置20采取可移动的支柱组件24的形式。可移动的支柱组件24可以例如经控制组件上的杠杆25致动(参见图11)。在两个实施方案(图7和10)中,稳定装置20都在引导装置的远端。
在另一个替代的实施方案中(参阅图12),稳定装置20采取邻近于引导装置的远端尖端的可膨胀构件26的形式。如图13中所示,可膨胀构件26例如可以经控制组件21上的杠杆25致动。然而,这类稳定装置20还可以构想是被充胀的。在所有的实施方案中稳定装置都可以用于稳定引导装置18,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,可以使用分开的稳定装置与引导装置18配合以通达血管。这种分开的稳定装置可以体现上述稳定装置的形式,也可以是某些其它的稳定机构的形式。
2.固着器施放器部件
图14描述固着器施放器27的一个实施方案,所述固着器施放器27形成固着器附着组件的一部分。部件27采取固着器施放器27的形式。图15描述固着器施放器27经引导装置18的空腔被布设在将安装固着器28的位置。
位于固着器施放器27的远端的是固着器驱动机构100(参见图14)。在所示的实施方案(参见图14A),驱动机构100包括连接在载体102上的驱动器29。在驱动器29与载体102之间的连接可以采取不同的形式,例如磁性体、抓握器,或者其它适当的机械连接。在图14A所示的实施方案中,驱动器29和载体102整合地连接成单个元件。
载体102尺寸和构形做成接合选取的固着器28。在图14A中,固着器采取图18和27中所示的螺旋形固着器的形式。如图27中最清楚地所示,下文将更加详细地说明,图26中的螺旋形固着器28是带有尖锐的前导尖端142的开放线圈148。固着器28的近端144包括L型的支脚146。该L型的支脚146有利地二等分线圈148的整个内径,即L型支脚146完全地越过线圈148的内径延伸,如图27所示。L型的支脚146起转动螺旋形固着器达到植入的固着器施放器27的载体102的作用。L型的支脚146还起止挡的作用防止螺旋形固着器过深地穿透进组织。
图14A中所示的载体102包括槽180,所述的槽180容纳L型支脚146以连接固着器28用于与载体102一起旋转。线圈148的圈数取决于在包围载体102的互补内沟槽32。沟槽32可以沿固着器28的整个长度或者其长度的一部分被定位。
驱动机构100的致动当然可以以各种方式完成,例如,机械的(即手工或者手动)、电气的、液压的或者气动的。在图示的实施方案(见图14B)中,驱动缆30把固着器驱动器29连接到支承在施放器手柄108中的电动马达106上。驱动缆30有利地由既允许弯曲也允许旋转的适当材料制造。受马达106的驱动(该马达转而受马达控制单元31的控制,下文将说明)。驱动缆30转动驱动器29,并且继而转动载体102。载体102向螺旋形固着器28传递旋转和力矩以植入在组织中。
图16是固着器施放器27和引导装置18的放大的截面图。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29和螺旋形固着器28之间的接合。图19描述固着器施放器27在固着器驱动机构100的动作过程中。驱动机构100的起动,作为一个单元转动驱动杆30、驱动器29、载体102和螺旋形固着器28。该旋转导致旋转形固着器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)。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。
在使用中,施放器27经引导装置18推进并与假体接触。操作者通过接触控制开关110致动控制元件31(参见图14和14B)。这个动作引导螺旋形固着器28被转动离开载体102并且穿过假体14然后进入血管壁14。马达控制单元31有利地转动驱动缆30,根据每个致动指令转动一定的转数。这可以通过合并一个机械的或者电气的计数器来完成。
固着器28的布设以后,经引导装置18收回施放器27,并且在载体102内加载另一个固着器28。重新定位和稳定引导装置18,并且重新经引导装置18推进施放器27并且进入与假体14接触。操作人员再次通过接触控制开关100致动控制单元31以布设另一个固着器28。这个过程在假体14的近端和/或远端都重复地进行直到假体14适当地附着和密封到血管壁34。可以构想在假体14的每个末端都可以施放大约二至大约十二个固着器28以进行锚着。固着器28可以以单个圆周间隔开的行施放,或者也可以以一个以上的行施放,同时单独固着器被轴向地对齐或者圆周地交错开。
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附着。
驱动机构100的一个替代的实施方案示于图25A和25B中。在此实施方案中,驱动器29被连接到形成螺旋形固着器28本身的一部分的载体150上,如还在图28A中所示那样。如图28A所示,与图27所示固着器相似,螺旋形固着器28是带有尖锐的前导尖端142的开放线圈148。固着器28的近端144包括载体150。
载体150包括槽182。槽182接合驱动器29上的驱动凸缘184(参见图25A)以在植入的过程中传递驱动器29的旋转使螺旋形固着器28转动。类似于图27所示的L型的支脚,载体150也起止挡的作用防止螺旋形固着器过深地穿透进组织。
载体150与驱动器29之间的接合连接可以以各种方式完成,例如通过分开的抓握器或者夹头、磁性连接,或者任何其它的机械连接手段。在所述的实施方案中,驱动器29用磁性材料制造,而载体150是用被磁性吸引向磁化材料的材料制造。当然,也可以使用磁化的和受磁性吸引的材料的相反的安排。
在此安排中,驱动缆30与马达106之间的马达连接132适应马达缆线30的轴向位移(图25A和25B的左和右),而不中断与马达106的驱动连接。在施放装置27的远端尖端与假体14接触后(参见图25A),操作人员通过接触控制开关110操纵控制单元31。控制单元31命令马达106转动驱动缆30以向驱动器29和磁性地附着的螺旋形固着器28传递旋转。这个动作引起磁性附着的螺旋形固着器28被旋进假体14和血管壁14(参见图25B)。由于磁性连接,随着固着器28向图25B的左方被布设,驱动器29运动与载体150串联(也是向图25B的左方被布设)。由于载体150与驱动器29之间的磁性连接,操作人员必须施加审慎的分离力才把载体150从驱动器29(并且与之一起把固着器28)脱开连接。该安排防止不利地松开固着器28。
如前所述,布设固着器28以后,经引导装置18收回施放器27,并且把另一个固着器28磁性地连接到驱动器29上。重新定位和稳定引导装置18,并且再次经引导装置18推进施放器27并且进入与假体14接触。操作人员再次通过接触控制开关110致动控制单元31以布设另一个固着器28。这个过程在假体14的近端和/或远端都重复地进行直到假体14适当地附着和密封到血管壁34。
如以上所说明,施放器部件27的外径的尺寸和构形有利地能够通经引导部件18的空腔,所述的引导部件18采取适当的可操纵的引导导管的形式,以引导施放器部件27到所希望的位置。还如上所述,施放器部件27有利地构形为每次植入一个固着器28(所谓的“单发”方法)。据认为这是有利的,因为它降低了设计的复杂性并且适应施放器27经过弯曲的解剖结构的通道。承载单个固着器的固着器施放器27可以比承载多个固着器的固着器施放器有较低的轮廓,并且可能更有效和较少创伤性。然而,在替代的实施方案中,施放器部件27,如果希望,也可以构形为承载多个固着器。而且,固着器施放器27可以如上所述以优选地圆周间隔开的图案同时布设多个固着器。
a.假体/组织接触传感
固着器施放器27有利地并入一功能,其防止施放器27在以所希望的程度接触假体或者组织表面之前致动马达106。这防止不利地排出固着器28和/或分离固着器28。这个功能例如可以使用在设计或是机械的或是电气的接触传感器或力传感器而得以实施。
当固着器施放器27是图14A、14B和14C所示类型时(参见图23和24),所述的接触传感或力传感功能可以例如利用载体102的远端尖端120传递接触力。该力可以被传递到例如位于固着器施放器手柄108内的力或传感开关112。在此安排中,开关112可以是致动器开关110和控制单元31之间的电路的一部分。
在所示的实施方案中,开关122包括静止的开关元件128(连接在手柄108的内部上)和可移动的开关元件130(由驱动缆31承载)。在此安排中,驱动缆30与马达106之间的马达连接132适应马达缆线30的轴向位移(图23和24的左和右方)而不中断与马达106的驱动连接。驱动缆30可移动的开关元件130,通过支座134连接到使开关元件130响应驱动缆30的运动而运动。静止的开关元件128不连接在滑动地通经开关元件130的可移动的驱动缆30上。
由于此安排,驱动缆30的轴向位移相对于开关元件128移动开关元件130。更加具体地,驱动缆30向图23中左方的位移使得开关元件130向左方移动,远离开关元件128。反之,驱动缆30向图23中右方的位移使得开关元件130,朝开关元件128向右移动。
弹簧126正常地偏置开关元件128和130,含有电气开路的状态。在此状态下,致动开关110的操作不起致动控制单元31的作用,因为电气开路的开关122中断了向马达控制单元31传输致动信号。当开关元件128和130在电气开路的状态时,驱动缆30向左被位移以把载体尖端120定位得越过固着器施放器27的远端尖端124。载体尖端120因此造成在施放器尖端124前面与假体14或者组织接触。
当载体尖端120以足以压缩弹簧126的力接触假体或组织表面时,驱动缆30对抗弹簧的偏置力向图23的右方被位移。这使得开关元件130向右移动。最终会发生开关元件128与130之间的接触,如图24中所示。这种接触建立了电气闭路的状态。在此状态下,操作致动开关110起致动控制单元31的作用。如图23和24所示,可以提供接触螺丝136以调节闭合开关元件128和130所需的位移量。
在取消了接触力后,或者没有充分的接触力时,弹簧126把开关元件128和130迫向电气开路的状态。载体102的远尖端远端地越过施放器27的远尖端而定位。
应当理解,载体尖端120的移动向开关122的转移不需要沿驱动缆30的整个长度发生。例如,开关122可以位于载体102与驱动器29之间的转移空间中。在此安排中,连接到驱动缆30的驱动器29不需要适应轴向位移。相反,响应与假体14接触的载体102向驱动器29的相对移动将机械地把载体10与驱动器29连接(例如,通过与图25A和25B类似的槽和凸缘连接),同时还闭合开关122以向致动器开关10与马达控制元件31之间的电路供电。
当固着器施放器27是图25A和25B所示的类型时(参见图26A、26B和26C),接触或者力传感功能例如可以利用可滑动地通经载体150`(载体150`示于图28B中)的中央通道192、驱动器29和驱动缆30。杆190连接到可移动的开关元件130。在此实施方案中,开关元件130在驱动缆30上左右转移,所述的驱动缆30在开关元件130内的支座134上转动。
如在上个实施方案中,弹簧126正常地偏置开关元件128和130,含有电气开路的状态。当开关元件128和130在此电气开路状态下时,力传感杆190被向左位移超过固着器施放器27的远端尖端124。从而力传感杆190使得在施放器尖端124前面接触假体14或支架结构16。
当杆190以足以压缩弹簧126的力接触假体或支架结构的表面时,杆190对抗弹簧126的偏转力向图26A的右方位移。这使得开关元件130向右移动。最终会发生开关元件128与130之间的接触,如图26B所示。这种接触建立了电气闭路的状态。在此状态下,操作致动开关110起致动控制单元31的作用。这个动作引起螺旋形的固着器28被转动进入支架结构16并且进入血管壁34(参见图26C)。由于驱动器29与载体150`之间的磁性连接,随着固着器28被布设,驱动器29被移向图26B中的左向与附着的载体150`串联。同样,由于驱动器29与载体150`之间的磁性连接,操作人员必须施加分离力以把载体150(并且,与它一起把固着器28)从驱动器29脱开连接。如前所述,此安排防止固着器28的无意释放。可以提供接触螺丝136调节闭合开关元件128和130所需的位移量。
在取消了接触力后,或者没有充分的接触力时,弹簧126把开关元件128和130迫向电气开路的状态,使得移动杆190的尖端越过施放器27的远端尖端124移动。
刚才说明的接触或力传感安排还可以向操作人员产生听觉和/或视觉输出,以指示在施放装置27与假体或组织之间存在足够的接触力。
B.成角的部件固着器引导和附着组件
在另一个安排(参见图29)中,固着器附着组件包含单元的成角的固着器引导和施放器部件160。在此安排中,部件160包括固着器驱动机构162,所述的固着器驱动机构162布置保持固着器28在对假体或者组织垂直或者近于垂直位置的载体164。该构形消除了以前所述的对固着器部件27的分开的可操纵的引导部件18的需要。
驱动机构18可以不同。在所示实施方案(示于图29中),所述的机构162包括连接在驱动缆30上的伞齿驱动齿轮168。驱动齿轮168运行地与连接在载体164上的变速齿轮或者说小齿轮179相啮合。驱动齿轮168和小齿轮170的旋转轴偏移约九十度,从而驱动缆30沿血管轴线的旋转被转换成载体164一般地垂直于血管壁的旋转。固着器引导和施放器部件160可以以各种方式定位和稳定在血管内,例如通过使用外部弹簧加载的柱或者类似物(如与上述的引导部件18相结合),或者通过使用可膨胀的构件166(如图29所示)。膨胀构件166可以含有气囊也可以含有机械的膨胀装置。膨胀构件166通过对抗血液的力直到可以锚着假体,在血管内稳定假体和固着器引导和施放器部件160的位置。
如图30所示,如果希望,固着器引导和施放器部件160可以提供在驱动缆30与载体164之间成角的布设,所述钩稍小于九十度,以辅助腔内操作载体成为对血管壁垂直接触的位置。如图31所示,如果希望,固着器引导和施放器部件160可以在驱动缆30与载体164之间被铰接。在此安排中,有利地提供遥控机构以把载体164从第一的用于布设到目标位置(在图31中用实线示出)的一般地径直的位置,移动到第二的用于把载体164对准与血管壁接触的被铰接的位置。
III.固着器
如前文图示和说明,引入固着器28典型地是在已经初始地安置了假体14以后进行。就是说,假体14的初始安置将通过自行膨胀或者气囊膨胀达到,此后通过引入多个单独的固着器把假体14固定或者说锚着在位。固着器28可以只经假体14的纤维布置,即避开支架结构。或者,固着器28可以被引入和通过支架结构本身的部分。假体14可以包括构型专门用于容纳固着器的预形成的插口,缝隙或环管。固着器28既可以经纤维也可以经支架结构引入。固着器28可以被单个地,即一次一个地,在假体14的内壁上以圆周间隔开的图案引入。
在示例性的实施方案中,固着器28是螺旋形固着器,从而它们可以被旋转和“螺丝拧入”假体14和血管壁内。螺旋形固着器28的一个有利的构形(参见图27、28A,和28B)是开放线圈148,很像盘簧。这种构形让固着器28能够捉住大面积的组织,产生较常规的卡钉大得多的保持力,而不必施加会造成组织坏死的组织压迫。
如图27、28A和28B所示,螺旋形固着器28的前导尖端142有利地是尖锐的,以使之能够穿透动脉壁和/或硬化的组织。远端尖端142可以是锋利的,以经组织切割出螺旋的路径,或者可以尖锐至一点以穿透组织而不进行切割。
固着器的近端144起两个设计功能的作用。第一功能是接合在植入过程中转动螺旋形固着器的固着器施放器27的载体102。第二功能是起止挡的作用防止螺旋形固着器过深地穿透进组织。
在一个实施方案(参见图27)中,螺旋形固着器28的近端144包括二等分固着器直径的线圈148的L型支脚。线圈148的L型支脚完全地跨过直径以防止固着器成为开放线圈并且控制穿透进组织的深度。另外,线圈148的支脚146可以被附着在前述的线圈上以强化整个结构和为固着器施放器提供更加稳定的驱动附着点。这种附着可以通过焊接、胶合或者任何其它适当的手段进行。
或者(如图28A和28B所示),固着器28的近端144可以合并分开的罩或者说载体150或150`,它起与图27中的线圈148的支脚146相同的作用。载体150或150`可以以若干个附着到固着器施放器驱动机构100的方法为特征。这些方法包括分开的抓握器、夹头、磁性连接(如前所述),或者任何其它适当的机械连接手段。在图28A和28B中,载体150和150′包括槽180和180′以匹配驱动凸缘(如前所述)。还是如前所述,可以在载体150和150`与相应的驱动构件之间实施磁性连接以防止在使用过程中无意地分开。
在图28B中,载体150`还包括用于固定图26A、26B和26C中所示的接触/力传感杆190的通道152。
图27、28A和28B中所示的固着器28可以用不锈钢或者其它类型的可植入的金属制造,然而,还可以设想以上说明的固着器可以用可植入的聚合物或者生物可降解的聚合物或者所有这些材料的组合制造。有利地,固着器28将有2至10圈并且将有1mm至10mm长。各个线圈之间的间隔将会是0.25mm至3mm。固着器28的直径会是1mm-6mm。
IV.带有整体的固着器组件的假体
图32示出包括至少包括一个整体的固着器组件502的假体500。图32示出假体500被布设在目标内腔区域中,特别是,在腹主动脉血管瘤504中。假体500可以被布设在身体内任何其它处。
假体500有利地包括由支持框或者支架504承载的纤维材料或者类似物,如前文所述。支架504可以用在布设过程中自行从鞘中径向膨胀的弹性材料制造,或者用响应通过气囊或者机械的膨胀装置在支架内施加的径向膨胀力而径向膨胀的有展性材料制造。
在目标区域中布设假体500以后,操纵在假体500上的整体的固着器组件502以把假体500锚着在血管壁上。在所示的实施方案中,假体500承载两个整体的固着器组件502上,在假体500的每个末端区中各一个。
在所述的实施方案中,每个固着器组件502都被嵌入在相应端区中的加强的凸缘区506中。每个固着器组件502含有一个圆周绕凸缘506间隔开的固着器508的阵列。在所述的阵列中固着器508的数量可以不同,例如在每个凸缘区506上各有大约二至大约十二个固着器。阵列的构形也可以不同,例如在圆周的阵列中,固着器508也可以是轴向地间隔开的。
固着器508可以用金属材料或者塑料制造,并且可以是不同的构造。在所述实施方案中,每个固着器508包括一个盘形的头部512和一个分杈成两个翼片516和518的柄514,所述的两个翼片516和518通过塑料或者记忆性材料铰接区520连接。铰接区520的材料用把两个翼片516和518偏置至展开状态的弹性记忆材料形成(如图34所示)。
每个固着器508都被承载在凸缘区506上的环管510内(参见图35)。当铰接区520被限于环管510内时(如图35所示),两个翼片516和518对抗弹性记忆被滞留于相邻的封闭的状态。响应于在头部512(参见图35)上所施加的推力或者冲击力,两个翼片516和518以封闭的状态被推出环管510,并且进入和穿过相邻的血管壁(参见图36)。在连续推进后,铰接区520从环管510的约束中脱开(参见图37)。结果,两个翼片516和518弹性地跳回其通常的展开状态。
在此安排中,在假体500内布设腔内工具522(参见图33),以在给定的固着器508的头部512上施加推力或者冲击力。在所述的实施方案中,工具522含有在其远端上承载冲击构件526的导管524。在一个所希望的安排中,导管524的远端是可操纵的,以辅助建立在冲击构件526与给定固着器508的头部512之间的点接触。头部512可以包括凹陷528以在使用过程中容纳和稳定相对头部512的冲击构件526的尖端。
在使用中,操纵冲击构件526以在选取的固着器头部512上施加推力或者冲击力。如图35和36所示,由冲击构件526施加推力迫使两个翼片516和518顶在血管壁34的近侧。两个翼片516和518还是在其封闭的状态,因为铰接区520仍受限于环管510中。封闭的两个翼片516和518随着向血管的远侧推进形成穿透组织的闭塞器。随着铰接区510脱离环管510(图37),两个翼片516和518对血管壁的远侧弹性地恢复至其展开的状态。在取走冲击构件526以后(参见图38),头部512和展开的翼片516和518以其互相对置的状态保留在血管壁中,以确保假体500对着血管壁。在使用时,医生相继地对每个固着器508定位和操纵冲击构件526,以完成假体500到血管壁的锚着。
在一个实施方案(参见图39)中,每个固着器508可以包括一条可释放地连接到头部512上的跟踪线530。所述的跟踪线530从头部512伸出体外以通达血管外部。在此安排中,冲击构件526包括一个空腔以适应跟踪线530的通过。跟踪线530在内腔途径引导冲击构件526至各自固着器5时。在操纵冲击构件526驱动固着器508进入血管壁以后,可以通过跟踪线530撤回冲击构件526。例如可以通过在跟踪线530上施加适度的拉力,跟踪线530可以从新固定的头部512上松开。然后可撤走跟踪线530。接着通过另一条跟踪线530引导冲击构件528以与另一个固着器508互动,直到达到所希望程度的锚着。
在一个替代的实施方案中,可以使用整合在假体500上的固着器组件502以在进行永久性的锚着技术时,临时地跟踪假体500到位。例如,在此安排中,在使用整体的固着器组件502 临时地保持假体500在所希望的位置后,以前述方式布设分开的螺旋形固着器28,以对血管壁永久性地锚着假体500
可以理解,本文说明的优选实施方案的组件和/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组合或者整体或者部分地修改。可以构想,引导装置、固着器施放器和螺旋形固着器的组件可以交替地彼此相对取向,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方法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附着其它的假体装置。
以上详细描述了本发明的实施方案,目的在于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在本公开内容范畴和精神内的其它修改。
Claims (46)
1.假体的固着器施放器,包含:
尺寸和构形做成可释放地连接到固着器上以向假体内布设固着器的驱动机构,和
驱动机构的致动器,所述的致动器包括传感机构,它使驱动机构的操作能够响应在固着器处或其附近所检测的力。
2.如权利要求1所述的固着器施放器,
其中当检测的力小于预定的量时传感机构使得驱动机构的操作失灵。
3.如权利要求1所述的固着器施放器,
其中传感机构包括响应在固着器处或者其附近所检测的力而被致动的开关组件。
4.假体的固着器施放器,包含:
尺寸和构形做成可释放地连接到固着器上以向假体内布设固着器的驱动机构,和
驱动机构的致动器,所述的致动器包括传感机构,它使驱动机构的操作能够响应在固着器处或其附近与表面所检测的接触。
5.如权利要求4所述的固着器施放器,
其中当没有检测到接触时传感机构使得驱动机构的操作失灵。
6.如权利要求4所述的固着器施放器,
其中传感机构包括响应在固着器处或者其附近所检测的接触而被致动的开关组件。
7.如权利要求1或4所述的固着器施放器,
其中驱动机构包括固着器的载体。
8.如权利要求7所述的固着器施放器,
其中所述的载体每一次容纳单个固着器。
9.如权利要求1或4所述的固着器施放器,
其中所述的驱动机构磁性地连接在固着器上。
10.如权利要求9所述的固着器施放器,
其中驱动机构每一次磁性地连接在单个固着器上。
11.如权利要求1或4所述的固着器施放器,
其中驱动机构机械地连接在固着器上。
12.如权利要求11所述的固着器施放器,
其中驱动机构每一次机械地连接在单个固着器上。
13.如权利要求1或4所述的固着器施放器,
其中驱动机构转动固着器用于布设。
14.如权利要求1或4所述的固着器施放器,
还包括尺寸和构形做成用于布设在目标身体区域中的导管体,和
其中至少一部分驱动机构由导管体所承载。
15.如权利要求14所述的固着器施放器,
其中导管体包括一个远端,和
其中传感机构包括远端地伸过导管体的远端的部件。
16.如权利要求15所述的固着器施放器,
其中所述部件包括固着器的载体。
17.如权利要求15所述的固着器施放器,
其中所述的部件包括力传感探头。
18.如权利要求1或4所述的固着器施放器,
还包括尺寸和构形做成用于腔内通过的导管体,和
其中至少一部分驱动机构由导管体所承载用于布设在目标血管内区域。
19.如权利要求18所述的固着器施放器,
其中导管体包括一个远端,以及
其中传感机构包括远端地伸过导管体的远端的部件。
20.如权利要求19所述的固着器施放器,
其中所述部件包括固着器的载体。
21.如权利要求19所述的固着器施放器,
其中所述部件包括传感探头。
22.尺寸和构形做成用于单独布设在组织中的固着器,包含:
固着器体,其具有用于响应一个力而穿透组织的远端和用于可释放地把固着器体连接到力施加器上的近端,和
与所述近端关联的止挡结构,用于防止固着器体过度地穿透进组织。
23.如权利要求22所述的固着器,
其中固着器体含有具内径的螺旋线圈,以及
其中止挡结构含有基本上跨整个内径延伸的线圈的一个支脚。
24.如权利要求23所述的固着器,
其中所述支脚把固着器体机械地连接到力施加器。
25.如权利要求22所述的固着器,
其中固着器体含有具内径的螺旋线圈,以及
其中止挡结构含有基本上跨整个内径延伸的一个罩。
26.如权利要求25所述的固着器,
其中所述的罩包括接合力施放器用的配件。
27.如权利要求25所述的固着器,
其中所述的罩包括受到磁化的材料。
28.如权利要求25所述的固着器,
其中所述的罩包括被磁化材料吸引的材料。
29.如权利要求22所述的固着器,
其中所述的止挡结构把固着器体连接到力施放器上。
30.如权利要求29所述的固着器,
其中所述的止挡结构包括受到磁化的材料。
31.如权利要求29所述的固着器,
其中所述的止挡结构包括被磁化材料吸引的材料。
32.如权利要求29所述的固着器,
其中所述的止挡结构机械地把固着器体连接到力施放器上。
33.如权利要求22所述的固着器,
其中固着器体含有螺旋线圈。
34.用于向体内的假体施放固着器的系统,包含:
固着器,其包含具有用于响应一个力而穿透组织的远端和一个近端的体部,和
尺寸和构形做成可释放地连接到固定器体的近端以施加力的驱动机构,和
驱动机构的致动器,其包括传感机构,使得驱动机构的操作能够响应下列至少一个:在固定器体的远端处或其附近所检测的力或者(ii)在固定器体的远端处或其附近与表面所检测的接触。
35.如权利要求34所述的系统,
其中固着器包括与近端相关联的止挡结构,用于防止固着器体过深地穿透进组织中。
36.如权利要求34所述的系统,
其中驱动机构的尺寸和构形做成每一次可释放地连接到单个固着器上。
37.如权利要求34所述的系统,
还包括尺寸和构形做成用于布设在目标身体区域中的导管体,和
其中至少一部分驱动机构由导管体所承载。
38.如权利要求34所述的系统,
还包括尺寸和构形做成用于腔内通过的导管体,和
其中至少一部分驱动机构由导管体所承载,用于布设在目标的血管内区域。
39.用于向体内的假体施加固着器的系统,包含:
固着器,其包含体部,具有用于响应一个力而穿透组织的远端和包括止档结构用于防止固着器体过深地穿透进组织中的近端,和
尺寸和构形做成可释放地连接到止挡结构上以施加力的驱动机构。
40.如权利要求39所述的系统,
其中驱动机构的尺寸和构形做成每一次可释放地连接到单个固着器。
41.如权利要求39所述的系统,
还包括尺寸和构形做成用于布设在目标身体区域中的导管体,和
其中至少一部分驱动机构由导管体所承载。
42.如权利要求39所述的系统,
还包括尺寸和构形做成用于腔内通过的导管体,和
其中至少一部分驱动机构由导管体所承载,用于布设在目标的血管内区域。
43.假体,含有:
假体体部,
由假体体部整体上承载的固着器组件,所述的组件包括至少一个响应于力施加器所施加的力而可布设进组织的固着器,和
连接到固着器上的跟踪线,用于引导力施加器与固着器操作性接触。
44.假体,含有:
假体体部,和
由假体体部整体上承载的固着器组件,所述的组件包括至少一个响应于力施加器所施加的非旋转力而可布设进组织的固着器。
45.如权利要求44所述的假体,
还包括连接到固着器上的跟踪线,用于引导力施加器与固着器操作性接触。
46.尺寸和构形做成用于单独布设在组织中的固着器,包含:
固着其体部,其具有用于响应一个力而穿透组织的远端和用于可释放地把固着器体连接到力施加器上的近端,和
连接到近端的跟踪线,用于引导力施加器与固着器操作性接触。
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