CN101991478B - 无展伸件的支撑构件 - Google Patents
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Abstract
本发明涉及无展伸件的支撑构件。具体而言,披露了一种至少部分地就地装配的无展伸件的支撑构件,过支撑构件包括非常柔韧的编织的管,当伸长时,该管变得非常长且直径非常小,从而能置于小直径导管内。支撑构件优选地由一个或多个超弹性材料或形状记忆材料如镍钛诺的细股线构成。当从导管释放时,支撑构件本身折叠成纵向紧凑的构形,这样,随着折叠的数量增加,支撑构件获得相当大的强度,该径向强度消除了对支撑展伸件的需要。支撑构件可以包括人工瓣膜的安装点。
Description
技术领域
本申请涉及和要求由Wilson等人于2005年5月27日提交的、名称为“无展伸件的支撑构件”、序列号为60/685349的美国临时专利申请以及由Wilson等人于2005年8月18日提交的、名称为“无展伸件的支撑构件”、序列号为60/709595的美国临时专利申请的优先权,这些申请也在此并入作为参考。本申请还并入由申请人在与本申请同一日期提交的、名称为“血管内的环带”、序列号为_____的美国专利申请和2005年5月27日提交的、名称为“血管内的环带”、序列号为60/685433的美国临时专利申请作为参考。
背景技术
使用一种经由皮肤的方法来改进和实行心血管外科手术一直存在着相当大的倾向。通过使用一个或多个引导通过例如股动脉的导管,能将工具和器械输送到心血管***中的所希望的区域,以执行大量的复杂疗法(或复杂的程序),这些复杂疗法本来通常需要侵入式外科手术疗法来完成。这种方法极大地减轻了病人所经受的创伤并能相当大地缩短恢复周期。作为实行心内直视手术的替代方案,这种经由皮肤的方法是特别有吸引力的。
瓣膜替换手术提供了正在发展中的经由皮肤的解决方案领域的一个示例。许多疾病导致心脏瓣膜小叶的变厚、和随后的不活动性或活动性降低。这种不活动性还可能导致通过瓣膜的通道变窄或狭窄。变窄的瓣膜所呈现的对血流增大的阻力最终可能导致心力衰竭并且最后死亡。
迄今,治疗瓣膜狭窄或心脏瓣口血液反流已包括通过心内直视疗法完全除去现有的原生(或天生)瓣膜,然后植入人工瓣膜。自然地,这是严重侵入式的疗法并且对身体造成很大的创伤,通常导致很大的不适和相当长的恢复时间。它也是一个需要很多专门技能和执行才能的复杂的治疗。
在历史上,用传统的心内直视手术实行这种瓣膜替换手术,在心内直视手术中,胸腔被打开,心脏停止,对病人应用心肺分流术,切除原生瓣膜并安装替换瓣膜。另一方面,在授予Andersen等人的美国专利6168614中披露了一种建议的经由皮肤的瓣膜替换备选方法,其全部内容在此并入作为参考。在该专利中,将人工瓣膜安装在一展伸件上,该展伸件被折叠成一个配装在导管内的尺寸,然后将导管***病人的脉管***中并移动导管,以便将折叠的展伸件置于原生瓣膜的位置处。启动展开机构,个展开机构使包含替换瓣膜的展伸件扩大紧靠在瓣尖上。该扩大的构件(或结构)包括一展伸件,该展伸件构形成具有带瓣膜小叶支撑件的瓣膜形状,扩大的构件开始担负原生瓣膜的作用,结果,完成了全部的瓣膜替换,相当大地减小了对病人的身体的影响。
然而,该方法具有一些缺点。在Andersen的6168614号专利中披露的经由皮肤的方法所带有的一个特别的缺陷是难以防止植入之后在新瓣膜周边附近的泄露。由于原生瓣膜的组织残留在管腔内,所以存在有很大的可能性,即瓣膜组织的缝合接合点和熔合点(由于被展伸件推开和固定)将造成在人工瓣膜周围的密封困难。实际上,这常常导致血液在展伸件设备周围的严重泄露。
Andersen的6168614号专利方法的其他缺陷与其对作为人工瓣膜支撑台架的展伸件的依赖有关。首先,展伸件能在它们扩大时产生栓塞物。其次,在展开过程中或在展开之后,展伸件通常不会有效地收集它们移走的栓塞物。第三,展伸件通常不会与它们被置于其中的原生管腔的特征相符,使得装放在展伸件内的人工瓣膜遭受瓣膜周围的泄露。第四,展伸件经受强度和可压缩性之间的折衷。第五,一旦展开,展伸件就不能恢复。第六,展伸件内包含瓣膜必然会增加展伸件-瓣膜的复合体的折叠直径,并且增加了必须输送到脉管***中的材料的口径。
关于第一个缺陷,展伸件通常属于两个种类中的一种:自扩大展伸件和可扩大展伸件。自扩大展伸件在装入导管中时被压缩,并且在从导管释放时扩大到它们最初的、非压缩的尺寸。自扩大展伸件通常由镍钛诺制成。充气囊式可扩大展伸件以压缩状态而非放松状态装入导管内。可扩大展伸件通常由不锈钢或其他可锻的金属制成。充气囊被置于展伸件内。在展开时,导管缩回并且充气囊膨胀,从而使展伸件扩大到所希望的尺寸。这两种展伸件类型都在扩大时表现出相当大的力。所述力通常强得足以使血栓裂开或爆裂,从而使动脉粥样硬化斑的碎片移走并变成栓塞物。如果正在植入展伸件以治疗变窄的脉管,则某种程度的这种扩大是所希望的。然而,如果植入展伸件仅仅是为了使原生瓣膜移位,则可能希望较小的力以减少产生栓塞物的机会。
关于第二个缺陷,如果产生了栓塞物,则扩大的展伸件通常具有间隔得非常开以有效收集任何被移走的物质的部件,常常必须采取二级预防措施,其包括网状物和冲洗口的使用。
第三个缺陷要归因于展伸件的相对的不弯曲性。展伸件通常依赖配合在展伸件周围的原生脉管的弹性特性。用来使受限脉管张开的展伸件不需要在脉管和展伸件之间的密封。然而,当用展伸件使原生瓣膜移位并装放人工瓣膜时,为了防止瓣膜周围的泄露,展伸件和脉管之间的密封是必需的。由于展伸件的非相配性的特性,该密封难以获得,特别是在使变窄的瓣膜小叶移位时。
第四个缺陷是可压缩性和强度之间的折衷。通过用较厚的部件制造展伸件来将展伸件造得较强或较大。因而,较强的展伸件不象较弱的展伸件那样可压缩。适合于在瓣膜中使用的大多数展伸件不可被压缩到足以置于小直径的导管中,例如20Fr、16Fr或甚至14Fr导管。较大的输送导管更难移动到目标区域,并且还给病人造成更多的创伤。
展伸件的第五个缺陷是它们不易于恢复。由于非弹性变形(不锈钢)或将展伸件保持在合适位置中所需的径向力(镍钛诺),所以一旦展开,展伸件就不能被再压缩和收回到导管中以便重新定位。因而,如果医生对展伸件的展开位置或方位不满意,他或她也几乎不能纠正该问题。
上面列出的第六个缺陷是瓣膜在展伸件内的结合极大地增加了输送假体器械所需的***的尺寸。结果,进入脉管***的进入孔的尺寸很大并且常常妨碍治疗,特别是对儿童、个子较小的成人或先前存在血管病的病人而言更是如此。
因而,本发明的一个目的是解决这些缺陷。具体地说,本发明的目的是提供一种支撑构件(或支承结构),其通过渐进的作用力逐渐扩大,从而将栓塞物的产生减到最少。
本发明进一步的目的是提供一种支撑构件,其收集任何所产生的栓塞物,从而防止栓塞物在下游引起伤害。
本发明的再一个目的是提供一种支撑构件,该支撑构件与它正在其中展开的管腔的特征相符,从而防止瓣膜周围的泄露。
本发明的又一个目的是提供一种能从直径非常小的导管展开的强的支撑构件。
本发明进一步的目的是提供一种支撑构件,其能缩回到输送导管中并在其中重新展开。
本发明的又一个目的是提供一种器械,其输送有与支撑构件的最终构形的内径明显分开的瓣膜,以便减小在病人的脉管***内输送器械所需的空间的量。
发明内容
通过提供一种用于原生管腔的管状网状物支撑构件,该支撑构件能经由直径非常小的输送导管输送,本发明实现了上述目的。管状网状物由一个或多个细股线形成,所述细股线一起编织成细长管。股线可以是含纤维的、无纤维的、多丝或单丝。股线表现出形状记忆以使得细长管可以形成所希望的折叠形状,然后伸展开形成直径非常小的、伸长的构形。直径小的伸长的构形使得直径非常小的输送导管变得可能。
在展开时,伸长的管被从输送导管慢慢地推出,其中它逐渐回到其折叠的、构造好的构形。管与目标脉管的内部几何形状相符。另外,编织物有效地收集可能从脉管壁释放的所有栓塞物。
当继续从输送导管推出管时,由于它回到其构造好的构形,所以它开始折叠到其本身上。由于它折叠到其本身上,所以每层施加的作用力加到一起,使得构件递增地变得更强。因而,可以在不改变器械的伸长的直径的情况下获得强度的变化水平。
利用该折叠的管,能装上瓣膜以使得瓣膜或输送导管内的在其伸长的构形中的其他构件(例如过滤器)不存在于伸长的管内,而是在展开时能位于管中、管上面或管下面。
附图说明
图1是处于细长构形中的本发明优选实施例的透视图;
图2是本发明优选实施例的侧视图;
图3-12是从输送导管中展开的本发明优选实施例的一系列透视图;
图13是本发明优选实施例的透视图;
图14是图13所示优选实施例的第一端视图;
图15是图13所示优选实施例的第二端视图;
图16是本发明优选实施例的侧视图;
图17是图16所示优选实施例的第二端视图;
图18是图16所示优选实施例的第一端视图;
图19是本发明优选实施例的侧视图;
图20是图19所示优选实施例的第一端视图;
图21是图19所示优选实施例的第二端视图;
图22是本发明优选实施例的局部透视图;
图23是本发明优选实施例的局部透视图;
图24是本发明优选实施例的透视图;
图25是图24所示实施例的侧视图;
图26是图24所示实施例的第二端视图;
图27-36是抵靠一畅通的塑料管从输送导管中展开的本发明优选实施例的一系列透视图,所述塑料管代表原生瓣膜;
图37是本发明优选实施例的侧视图;
图38是图37所示实施例的下游侧的端视图;以及
图39是图37所示实施例的上游侧的端视图。
具体实施方式
现在参考附图并首先参考图1,其示出有一个处于伸展构形中的本发明的无展伸件(或无支架)的支撑构件(或支承结构)10。瓣膜支撑件10包括第一端12、第二端14以及在第一端12和第二端14之间延伸的细长管状本体16。
细长管状本体16优选地由一个或多个编织的股线18形成。该编织的股线18是超弹性材料或形状记忆材料如镍钛诺制成的股线。编织股线以形成一个管,该管具有穿过其中的中央管腔20。
在一个实施例中,管状本体16成两半地(或以一半)折叠在其自身上以使得第二端14变成一折叠端,而第一端12包括多个未编织的股线。因而管状本体16是双层的。将第一端12的未编织的股线聚拢并结合到一起,以形成多个聚拢端22。可以将聚拢端22用作为用于将人工瓣膜安装到支撑构件10上的连合点(例如看图2)。作为选择,如图1中所示,可以将聚拢端22用作为限定多个连合点26的丝制件24的接附点。
值得注意的是,连合点26定位成使得当在展开的构形中将瓣膜装接到支撑构件上时,瓣膜与支撑构件纵向地并列而不是位于支撑构件内。该并列允许将支撑构件10和瓣膜封装到非常小的导管中而不会损坏脆弱的瓣膜。当支撑构件呈现折叠的或构造好的构形时(例如看图19)可以保持该纵向并列,或瓣膜可以在支撑构件内变成折叠的。
图3-6表示第二端14,其从导管28中显现出来以使第一层30暴露。在图7中,第一层30完全暴露并呈现其构造好的构形。值得注意的是,第一层30在完全展开时纵向地收缩。在图7中还示出了开始从导管28显现出来的第二层32。当第二层退出导管时,预先设置的超弹性折叠部使网状物内翻,以使得第二内部层形成在第一外部层内。作为选择,第一层能紧靠脉管结构(例如动脉、静脉、瓣膜或心肌)的壁展开。当第二层退出导管时,医生能通过使展开***前进来帮助网状物的内翻。在另一实施例中,在由于拉动或缩回展开***而发生网状物内翻的场合,能使网状物支撑构件在脉管***中前进以使得它沿相反方向展开(例如展开通过心室的尖或从静脉***展开)。
在图10中,第二层32完全展开并且第三层34完全暴露,但还没有内翻。在使导管28相对于目标位置稍微前进时相对于器械10缩回导管28使得第三层34向内“突然伸出”,从而使其本身紧靠第二层32的内表面内翻,如图11中所示。
在图12中,从导管28中放出另外的材料以使得第三层34紧靠第二层完全扩大。本领域技术人员将会理解,能以这种方式获得许多另外的层,并且每个层都给最后所得到的支撑构件10增加了额外的径向强度。
在整个展开过程中,无展伸件的支撑构件10逐渐从输送导管28中显现出来。在希望重新定位支撑构件10的情况下,该特性也允许将构件10拉回到输送导管28中。这么做使得支撑构件10重新获得其展开的构形。
已经描述了就地建立支撑构件的技术性细节,现在能将注意力转向由于本发明而变成可能的不同实施例。图13-15表示具有许多层38和第一端12的支撑构件10,第一端12带有许多由未编织的股线形成的聚拢端22。聚拢端22中的一些装接到具有三个连合点26的丝制件24。所采集的或制造的人工瓣膜36装接到丝制件24上。图15表示支撑构件10的内部管腔20。
图16-18表示具有较少的层38和丝制件24的支撑构件10,人工瓣膜36装接在丝制件24上。丝制件24装接在第一端12上,第一端12(被隐藏)预先形成为在展开时向内折叠。因而,当支撑构件10处于构造好的构形中时,丝制件24和人工瓣膜36位于支撑构件10的内部管腔20中。
图19-21表示带有几个层38和第一端12以及折叠的第二端14的支撑构件10,第一端12预先形成为具有比其余的层小的直径。第一端12处的未编织的股线的末端没有形成聚拢端。相反,丝制件24装接在编织物上。人工瓣膜36装接在丝制件24上并且具有位于端部12外侧周围的裙部组织40。裙部组织40可以粘附到第一端12上。
图22表示无展伸件的支撑构件10和夹在两层折叠部之间的材料42,所述支撑构件10带有已向后折叠到其本身上的折叠端14。材料42用来进一步改进无展伸件的支撑构件10的脊椎旁泄露防止特性和栓塞物收集特性。材料42能由非织造材料、织造或编织织物、聚合物或其他材料构成。
图23表示包括纤维44的无展伸件的支撑构件10,纤维44大于包括支撑构件10的其余股线。因而,图23表明可以在编织的支撑构件10中使用不同尺寸的股线而不会显著影响器械的最小输送尺寸。可以使用尺寸不同的股线以便改进强度、提供刚度、产生瓣膜安装点、提供不透射线的标志等等。
图24-26表示具有第一端12的无展伸件的支撑构件10,第一端12具有未编织的股线,未编织的股线被修剪以使得它们不会延伸超过折叠的构件10的第一端12。该实施例可以用来创造、保持或扩大管腔。可以或不可以将人工瓣膜装接到该实施例上。
现在转向图27-36,其示出了无展伸件的支撑构件10的优选实施例的展开顺序,由此一段畅通的管道46用来表明原生脉管例如原生瓣膜的目标位置。在图27中,使输送导管28前进超过目标瓣膜46并且正在开始从导管28中放出无展伸件的支撑件10。
在图28中,已经放出了足够的无展伸件的支撑件10,使得第二折叠的端部14已经开始稍微向后卷曲到其本身上,形成袖口部48。在图29中,袖口部48更明显并且呈现其完全展开的形状。袖口部48充当医生能用来视觉地或触觉地定位目标瓣膜46并使无展伸件的支撑件10座靠在目标瓣膜46上的锁环(或捕捉件)。袖口部还起作用以确保通过目标瓣膜46的整个原生管腔现在正在被支撑件10透过(或过滤)。与充气囊式可扩大展伸件不同,无展伸件的支撑构件10的展开不会相当大地阻止血流。在图29中还示出了第一层30已经完全从导管28中放出,第二层32中的许多也从导管28中放出。第一层30能与目标脉管的任何形状相符,第一层30在被随后的层加强之前是非常柔韧的。第二层32还没有使其本身内翻到第一层30中。
在图30中,第一层30被展开,袖口部48正在抵靠瓣膜46起作用,并且第二层32已经内翻。在图31中,从导管28中放出了形成第三层34的材料,但第三层34还没有内翻。
在图32-33中,正在使导管28前进以允许第三层34内翻到第二层32中。图32的角度示出了由第一和第二层30和32产生的较低的型面,和支撑构件10造成的对血流的阻力怎样的少。
在图34中,第一端12已从导管12显现出来,并且示出了聚拢端22。丝制件24装接在聚拢端22中的一些上并且几乎从输送导管28中完全展开。在图35-36中,支撑构件10已经被从导管28完全释放出来,图36示出了支撑构件10的管腔20的大小。
图37-39表示本发明的优选实施例100,其包括网状物支撑构件102、丝制件104和瓣膜106。支撑构件102与前述支撑构件10稍有不同,因为它由两个单独的金属线108构成。在编织过程完成时,金属线的两个自由端接合在一起。象这样,没有自由的金属线端,并且能在单层的状态(未示出)中将构件装入输送导管中。在图中所示的展开状态中,支撑构件102折叠一次以形成双层的器械。
支撑构件102优选地由记忆合金形成,例如镍钛诺。单金属线构造允许将器械压缩到非常小的导管中,例如尺寸为16Fr或更小的导管中。虽然支撑构件通过双层的展开构形获得刚性,但径向强度是几个因素的函数,因而能相差很大地改变。
首先,如同其他实施例一样,可以通过将更多的折叠部或层并入到支撑构件102的展开构形中来增加径向强度。图37-39中所示的三层构形是最优选的构形,因为它仅仅必需折叠在其本身上两次,使得展开的复杂性较小。
第二,可以通过使用较粗的金属线来增加强度。因为支撑构件102由单金属线制成,这样能在单层的构形中将其装入导管中,所以可以在保持小直径的细长外形的同时使用直径较大的金属线。根据本发明用单金属线构造支撑构件102,所述单金属线的直径在0.005和0.010英寸之间。优选地,金属线的直径在0.007和0.008英寸之间。
第三,可以通过增加编织物密度来增加强度。较紧密的编织物将导致较强的支撑。
第四,可以通过改变热定形参数来增加强度。超弹性和形状记忆合金例如镍钛诺通过热定形在脉管***内实现它们的展开形状。金属线被保持在所希望的构形中并被加热到预定温度一个预定时间段。在金属线冷却后,它们被定形成新的构形。如果随后破坏了金属线的外形,则在加热或仅仅释放金属线时,它们将恢复到定形构形。能通过改变使构形定形的温度或通过改变将合金保持在高定形温度的时间段来增加使超弹性或形状记忆合金恢复到定形构形的作用力。例如,将本发明的镍钛诺支撑构件定形在530℃7分钟已经获得了好的结果。通过将构件定形在与530℃不同的温度或通过将构件定形在530℃一个与7分钟不同的时间,或通过同时执行上述两种方法,能用相同的镍钛诺金属线制造较硬的支撑构件。
器械100包括丝制件104,瓣膜106安装到丝制件104上。丝制件104形成被弓形部分110分开的连合点109。弓形部分110装接到支撑构件102的内表面上。连合点109便于瓣膜106的自然且有效的打开和关闭。作为选择,能将瓣膜连合点安装到支撑构件的外表面上(未示出)。
瓣膜106可以是任何形式的人工或采集的生物瓣膜。优选地,如图中所示,瓣膜106是具有三个小叶的瓣膜。将瓣膜106缝合到丝制件104上或用不同的方法装接到丝制件104上。优选地,将瓣膜106切割或构造成包括裙部112,裙部112沿着处于其展开构形中的支撑构件102的长度延伸。
虽然已经根据特定的实施例和应用描述了本发明,但按照本发明的教导,在不背离所要求保护的发明的精神或超过所要求保护的发明的范围的情况下,本领域普通技术人员之一能作出另外的实施例和变型。因而,应当理解,本申请中附图和说明书是作为例子提供的以便于本发明的理解,其不应被解释成对本发明范围的限制。
Claims (14)
1.一种无展伸件的支撑构件,它包括:
至少一个股线,其被编织形成具有第一构形和第二构形的管状构件;
由此在所述第一构形中,所述管状构件包括:
第一端和第二端;
在所述第一端和所述第二端之间的细长本体;
由此在所述第二构形中,所述管状构件包括至少一个折叠部,所述折叠部产生所述本体的具有多于一层的部分;
装接在所述第一端和所述第二端之一上的丝制件;
形成于所述丝制件上的组织瓣膜。
2.如权利要求1所述的无展伸件的支撑构件,其特征在于,所述至少一个折叠部在所述第二构形中使所述本体纵向地缩短。
3.如权利要求1所述的无展伸件的支撑构件,其特征在于,所述管状构件包括在所述第一构形中的单层。
4.如权利要求1所述的无展伸件的支撑构件,其特征在于,所述管状构件在所述第二构形中包括多层的部分。
5.如权利要求1所述的无展伸件的支撑构件,其特征在于,在所述第一构形中,所述无展伸件的支撑构件能用20Fr导管的管腔装放。
6.如权利要求1所述的无展伸件的支撑构件,其特征在于,所述第一端包括未编织的端。
7.如权利要求1所述的无展伸件的支撑构件,其特征在于,所述第二端包括折叠端。
8.如权利要求1所述的无展伸件的支撑构件,其特征在于,所述第一端包括多个连合装接点。
9.如权利要求1所述的无展伸件的支撑构件,其特征在于,所述第一端包括多个未编织的股线,所述未编织的股线结合起来形成至少一个连合装接点。
10.如权利要求1所述的无展伸件的支撑构件,其特征在于,编织在一起形成管状构件的所述至少一个股线包括多个第一直径的股线和至少一个第二直径的纤维,所述第二直径大于所述第一直径。
11.如权利要求1所述的无展伸件的支撑构件,其特征在于,所述第一端包括具有多个连合装接点的丝制件。
12.如权利要求1所述的无展伸件的支撑构件,其特征在于,所述无展伸件的支撑构件还包括所述管状构件的内壁中的衬里。
13.如权利要求4所述的无展伸件的支撑构件,其特征在于,所述多层的部分包括第一层和第二层,其中,所述无展伸件的支撑构件还包括夹在所述第一层和所述第二层之间的衬里。
14.一种无展伸件的支撑构件,它包括:
股线,其被编织以形成具有第一构形和第二构形的管状构件;
由此在所述第一构形中,所述管状构件包括:
第一端和第二端;
在所述第一端和所述第二端之间的细长管状本体;
由此在所述第二构形中,所述管状构件包括:
至少一个折叠部,所述折叠部使所述本体缩短并产生所述本体的一个部分,所述部分具有的层数至少两倍于处于展开的构形中的所述本体的层数;
装接在所述第一端和所述第二端之一上的丝制件;
形成于所述丝制件上的组织瓣膜。
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CN2010105330688A Active CN101991478B (zh) | 2005-05-27 | 2006-05-30 | 无展伸件的支撑构件 |
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CN2006800275120A Active CN101247773B (zh) | 2005-05-27 | 2006-05-30 | 无展伸件的支撑构件 |
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EP (3) | EP3072475B1 (zh) |
JP (6) | JP5289049B2 (zh) |
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AU (1) | AU2006251938B2 (zh) |
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