CN105246540A - 用于除去左心耳的装置和方法 - Google Patents

用于除去左心耳的装置和方法 Download PDF

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CN105246540A
CN105246540A CN201480014583.1A CN201480014583A CN105246540A CN 105246540 A CN105246540 A CN 105246540A CN 201480014583 A CN201480014583 A CN 201480014583A CN 105246540 A CN105246540 A CN 105246540A
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atrial appendage
foamed materials
left atrial
appendage occlusion
far
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阿龙·V·卡普兰
戴维·梅兰松
卡罗尔·德韦利安
安迪·H·莱文
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Abstract

用于闭塞左心耳(LAA)的装置和方法,以防止血液在LAA内凝固并且然后成为栓塞,尤其在患有心房颤动的患者体内。用牢固的抗血栓膜封装的泡沫材料植入物通过经血管方式放入LAA内并用粘合剂/和或机械锚状物锚定。优化组织增生和内生,以将植入物锚定到位并提供永久性闭塞。

Description

用于除去左心耳的装置和方法
相关申请的交叉引用
根据美国法典第35篇第119条(e)款,本申请要求2013年3月13日提交的美国临时申请第61/779,802号的优先权,将该申请整体结合到本文中以作参考。
本发明的技术领域
在本文中公开的实施方式涉及用于闭塞左心耳(LAA)的装置和方法,以防止血液在LAA内凝固并且然后成为栓塞,尤其在患有心房颤动的患者体内。
本发明的背景技术
心房颤动(Afib)是一种左心房(LA)的正常跳动混乱并且无效的疾病。左心耳(LAA)是LA的盲袋。在患有Afib的患者体内,血液在LAA内停滞,促使凝块形成。这些凝块(或凝块碎片)具有成为栓塞或离开LAA并且进入体循环的趋势。在凝块/凝块碎片成为栓塞并闭塞灌注大脑的一个动脉时,发生中风。抗凝血剂(例如,香豆素)已表现出显著降低Afib患者中风的风险。这些药物减少凝块形成,但是也增加了出血性并发症,包括出血性中风、硬脑膜下血肿以及胃肠道出血。
在美国和欧洲,大约有800万人患有Afib。这些患者中有大约460万人发生中风的风险很高,并且将受益于抗凝作用。这些患者中的大部分不能采用抗凝剂,这是因为增加了出血危险,留下他们的中风危险未解决。Afib的患病率随着年龄增加。
在现有技术中描述了用于闭塞LAA的几种装置,并且每个装置都具有局限性,本发明对此加以改进。现有技术装置是金属结构,这些结构的横截面是圆形并且制造成膨胀以填充LAA孔。这些装置以多种尺寸提供并且必须与非常多变的LAA解剖密切匹配。使用荧光检查难以做到这一点,并且通常需要经食管超声心动图、心脏CT以及MRI形式的辅助成像,所有这些都使用三维重建。如果装置明显尺寸过大,那么LAA孔可能变得过度拉伸,导致撕裂,造成心包腔内出血。如果装置太小,那么它将不能充分地密封孔并且可易于成为栓塞。即使尺寸正确,装置也促使椭圆形LAA孔采用圆形装置,不良密封往往导致在边缘具有残余漏。
在主要使用一系列径向设置的倒钩或挂钩的现有技术装置中描述了将这些植入物锚定在合适位置中,在装置膨胀之后,这些倒钩或挂钩接合到周围的心脏组织内。因此,装置必须具有足够的弹簧力或刚度以用于倒钩与周围的组织接合。这些倒钩可导致血液通过组织泄漏到心包腔内,这可造成心脏压塞。而且,一旦植入物完全膨胀,这些倒钩和挂钩的几何图形阻止额外定位。
出于所有这些原因,将期望具有这样一种装置,该装置不需要要求大量术前成像的过量尺寸,在完全膨胀和固定时能复位,无需一系列挂钩或倒钩。
本发明的概要
在本文中公开了用于闭塞左心耳(LAA)的装置和方法,以防止血液在LAA内凝固并且然后成为栓塞。这些构思包括通过导管输送装置的能力,通过血管系统经由导丝(guidewire)跟踪该导管。描述了泡沫材料(foam),这些泡沫材料塌陷以用于输送,并且然后在LAA内膨胀到位。这些塞子的锚定通过组织从LAA内生到泡沫材料、粘合剂、倒钩或远端锚定元件内来进行。描述了泡沫材料塞子,这些泡沫材料塞子用外壳(jacket)封装,这些外壳足够牢固,以能够在不撕裂的情况下处理塞子,并且还促使至少在近端的LA面向侧上形成新生内膜。
根据本发明的一个方面,提供了一种左心耳闭塞装置。该装置包括可膨胀的开孔泡沫材料本体,该泡沫材料本体具有近端、远端以及侧壁。外皮覆盖至少泡沫材料本体的近(心房)端,并且可膨胀的内腔延伸穿过泡沫材料本体。内腔可支撑输送导管和/或导丝的一部分,但是在去除这种部件时塌陷至接近零的横截面面积。这个特征降低了在中心内腔内形成栓塞并移动到血流内的可能性。泡沫材料本体能压缩在具有不超过大约20F的内径的输送导管内,并且在从输送导管释放时可自膨胀至至少大约25mm的直径。
在本发明的一个实现方式中,外皮(skin)包括ePTFE。外皮可遍及导丝内腔的长度延伸,并且可另外覆盖远端的至少一部分以及泡沫材料本体的近端。在一个实施方式中,外皮包括管状的ePTFE封套,该封套在开孔泡沫材料本体内延伸穿过导丝内腔,并且往回翻转到泡沫材料本体的外部之上,以用于连接至其本身,以包围开孔泡沫材料本体并装衬导丝内腔。
优选地,至少一个组织内生表面设置在泡沫材料本体的侧壁上,例如,通过穿过外皮设置至少一个孔,以将开孔泡沫材料本体放置成与相邻组织直接接触。组织内生表面可包括泡沫材料本体的侧壁的表面面积的至少大约20%、40%、60%、80%或更多。
可设置至少一个不透射线的标记(例如,不透射线的线或线状物(thread)),和/或泡沫材料和/或外皮可装有或浸有不透射线的填料(例如,硫酸钡、碱式碳酸铋或钨),以允许荧光检查可视化。可设置至少两个或更多个组织穿刺元件或其他锚状物。
根据本发明的另一个方面,提供了一种左心耳封闭系统。该系统包括输送导管,该输送导管包括细长的柔性管状本体,该管状本体具有近端和远端以及延伸穿过其中的至少一个内腔。被压缩在输送导管的远端内的自膨胀式开孔泡沫材料本体承载覆盖泡沫材料本体的至少一部分的外皮以及延伸穿过泡沫材料本体的导丝。轴向可移动的展开控制器(例如,推丝(pushwire))延伸穿过内腔,以用于从封闭系统的远端展开泡沫材料本体。
该系统可另外包括导丝,在该导丝上具有充气气囊。优选地,至少一个组织内生区设置在泡沫材料体上,例如,通过经由外皮内的至少一个窗口露出开孔泡沫材料本体。
附图的简要说明
将参照附图进一步解释目前公开的实施方式,其中,在这几幅图中,相似的结构由相似的数字指代。所示的示图不必按比例绘制,反而通常将重点放在说明目前公开的实施方式的原理上。
图1示出了左心房和左心耳的解剖图;
图2示出了使用粘合剂的将一个泡沫材料塞子实施方式设置到位的左心耳;
图3示出了泡沫材料塞子的x射线图像;
图4示出了将泡沫材料实施方式和远端锚状物设置到位的左心耳;
图5示出了螺旋锚;
图6示出了泡沫材料塞子实施方式的纵向横截面;
图7示出了LAA横截面;
图8是接近左心耳的孔的导向导管的示意图;
图9是与在图8中一样的示图,并且将导丝放置在左心耳内;
图10是与在图9中一样的示图,并且将位于导丝的远端区域的充气气囊定位在左心耳内;
图11是与在图10中一样的示图,并且导向导管沿着导丝向远端前进并进入左心耳内;
图12是与在图11中一样的示图,示出了定位在导向导管内的闭塞装置和推动器;
图13是与在图12中一样的示图,示出了部分展开而离开导向导管的闭塞装置;
图14是与在图13中一样的示图,示出了完全展开在左心耳内的闭塞装置;
图15是与在图14中一样的示图,示出了粘合剂或其他锚定结构的展开以将闭塞装置保持在左心耳内;
图16以纵向横截面示出了使用金属和泡沫材料的塞子闭塞装置;
图17示出了使用金属箔和泡沫材料的塞子;
图18示出了使用单个金属箔的塞子;
图19示出了具有扩张的远端末端的塞子;
图20示出了具有近端和远端盖子的塞子;
图21示出了塞子粘合剂输送系统;
图22示出了发泡系统的输送;
图23示出了具有倒钩的塞子;
图24示出了具有取回缝合线附接的塞子;
图25A和25B示出了远端锚定系统;
图26示出了可替换的远端锚定系统。
虽然以上确定的附图阐述了目前公开的实施方式,但是还设想了其他实施方式,如在讨论中所提到的。本公开通过代表而非限制的方式呈现了说明性实施方式。本领域的技术人员可设计落在目前公开的实施方式的原理的范围和精神内的多个其他修改和实施方式。
优选实施方式的详细说明
在图1中示出了具有左心耳(LAA)102的心脏100,该左心耳是源自左心房(LA)104的空腔。LAA102的形状在所有维度上具有很大差异。如果心脏不正常跳动(被称为心房颤动的疾病),那么LAA内的血液变得停滞,这促使凝块形成。如果血液在LAA内凝固,那么凝块可从LAA102进入LA104,进入左心室106,并且从心脏100出来,进入主动脉。使血液进入大脑的血管与主动脉分开。如果凝块通过这些血管进入大脑,那么它可被卡住,并且阻塞大脑内的小血管,这于是造成缺血性中风。中风具有与此相关的严重并发症。
LAA102到LA104的开口被称为孔110。本发明的目标在于,闭塞孔110,从而从LAA102密封LA104。孔110是椭圆形的、非常多变的并且依赖于负载条件,例如,左心房压力。
在图2中示出了LAA闭塞装置的一个实施方式。闭塞装置或塞子204在其至LA202的开口处放置在LAA200内。塞子204包括可膨胀介质,例如,开孔泡沫材料,该开孔泡沫材料能够使塞子塌陷和膨胀并且还能够增强组织内生到泡沫材料内。泡沫材料塞子204至少部分地封装在牢固的薄层206(例如,ePTFE(膨体聚四氟乙烯)、聚烯烃或聚酯)内。可替代地,可使用生物可吸收材料,例如,PLA、PGA、PCL、PHA或胶原。这个封装薄层可定向或者另外修改为在至少一个方向上(例如,径向地)具有弹性。
塞子可由聚氨酯、聚烯烃、PVA、胶原泡沫材料或其混合物制成。一种合适的材料是具有100-250um的孔径和90-95%的空隙率的聚碳酸酯型聚氨酯脲泡沫材料。该泡沫材料可为不可降解的或使用可降解材料,例如PLA、PGA、PCL、PHA和/或胶原。如果可降解,那么来自LAA的组织随着时间将生长到泡沫材料塞子内并取代泡沫材料。在不受约束的膨胀中,塞子204的形状可为柱形,但也可为锥形,其远端小于近端或相反。其横截面还可为椭圆形,以更好匹配LAA的开口。
在不受约束的膨胀中,泡沫材料塞子204在径向上具有超大尺寸,以紧密配合到LAA内,并且根据目标LAA的直径,直径可为5-50mm。塞子的长度与其直径相似或者大于其直径,以使L/D比率是大约或大于约1.0或大于约1.5或大于约2.0,以使其稳定性达到最大。材料的柔性设计成使得其以足够大的力推动LAA的壁部,以将塞子保持在位,而不会过度拉伸LAA壁部。泡沫材料和/或外皮随着它膨胀也符合LAA的不规则表面,以给原生的LAA壁部提供互补的表面结构,以进一步增强锚定并促进密封。因此,虽然现有技术中的一些左心耳闭塞装置包括机械框架,该机械框架迫使左心耳的至少一些方面形成圆形构造,但是本发明的可膨胀泡沫材料植入物符合左心耳的原生构造。在一个实施方式中,泡沫材料的结构可制造成轴向地挤压泡沫材料的相反端部以促使泡沫材料的直径增大。
ePTFE或泡沫材料可设置有一个或两个或更多个不透射线的标记(例如,不透射线的线状物210)或者装有或浸有不透射线的填料(例如,硫酸钡、碱式碳酸铋或钨),这允许操作者在x射线下看到塞子,以用于在解剖时正确定位。在图3中示出了x射线图像,其中,人们不能看到泡沫材料塞子300,但是可清晰地看到线状物302和褶皱304(下文讨论)。这个线状物或带状物可由不透射线的金属线(例如,铂或钨)或具有不透射线的填料(例如,钡、铋、钽、钨、钛或铂)的聚合物制成。
外部ePTFE层可由管状物形成,该管状物的直径与泡沫材料塞子的直径大致相同并且壁厚在大约0.0001”到大约0.001”厚之间,并且该外部ePTFE层用于允许在不撕裂泡沫材料的情况下使塞子塌陷和拉动塞子。ePTFE材料还用作面对左心房202的血液接触表面并且具有孔隙或节点,以使血液成分凝固在表面上,并且组织的内膜或新生内膜覆盖物穿过其中,并且牢固地锚定至该材料。在大约4μ到大约110μ的范围内(理想地,5-35μ)的孔径可用于新生内膜的形成和粘附。
外部覆盖物206可由除了ePTFE以外的材料构成,例如,由FEP、聚丙烯、聚乙烯、聚酯或尼龙制成的织物、网状物或穿孔膜。覆盖物应具有低柔量(非弹性),至少在纵向上足够牢固,以允许去除塞子,具有低摩擦系数,并且抗血栓(thromboresistant)。由于大部分泡沫材料没有牢固到足以在拉动时抵抗撕裂,所以该外部覆盖物用作基体,以允许去除塞子。塞子还涂有或含有材料,以提高其超声波回声分布、抗血栓性、润滑性,和/或促进超声心动图可视化,促进细胞内生和覆盖。
外部覆盖物在其中具有孔,以允许LAA组织与泡沫材料塞子接触,以促使组织内生到泡沫材料塞子孔内。这些孔的直径可为1到5mm,或者还可为椭圆形,其长轴与泡沫材料塞子的轴线对准,其长度可为泡沫材料塞子的长度的80%并且宽度可为1-5mm。孔可尽可能大,以使外部覆盖物保持足够的强度,以传输用于去除所需要的张力。孔可优先地沿着装置设置。在一个实施方式中,将孔设置在远端,以增强组织从LAA壁部内生。
在一个实现方式中,植入物设置有ePTFE的远端和近端盖子,该远端和近端盖子由ePTFE的两个或三个或四个或更多个轴向延伸的条带连接在一起。轴向延伸的条带彼此周向隔开,以提供至少两个或三个或四个或更多个面向侧面的窗口,通过这些窗口,开孔泡沫材料本体将与左心耳的组织壁部直接接触。这个外部覆盖物还可为网状物或织网。如图20中所示,覆盖物2004仅仅位于塞子2000的近端和远端表面上。该近端和远端表面可粘合至泡沫材料塞子,并且然后卷曲到中心管2002。
在LAA内将泡沫材料塞子粘附到位的一种方式是使用粘合剂,例如,低粘度氰基丙烯酸盐粘合剂(1-200cps)。粘合剂在泡沫材料塞子208的远端附近沿着侧壁注入到位。ePTFE覆盖物内的孔允许粘合剂在泡沫材料塞子204与LAA壁部200之间相互作用。粘合剂的注入可通过几种方式实现,一种方式是通过导管注入中心内腔212内。通道214用于将粘合剂引入正确的位置。此时必须限制泡沫材料塞子的远端,以防止粘合剂离开远端褶皱216。可替代地,图21示出了管子2104,这些管子通过导向导管2102、通过塞子2106的中心内腔预先放置,并且在LAA中向后弯曲至塞子2100的远端。这些管子2104一直通向导向导管2102的近端,在此附接有配件,以允许注入粘合剂,该粘合剂然后在塞子的期望位置离开小管子2104。这些管子由聚乙烯、聚丙烯或FEP制成,以使粘合剂将没有粘附至管子。在通过导向导管注入之后,从患者身上抽出这些管子2104。
可使用其他单一粘合剂,包括水性交联粘合剂、聚氨酯、PEG、PGA、PLA、聚己酸内酯或甜菜碱衍生的聚氨脂。此外,这些粘合剂可由两种成分构成,以使一种成分粘附至泡沫材料,并且第二种成分注入到活的有机体内。而且,这两种成分粘合剂可同时注入,以在活的有机体内混合,以防止污染注入管。
用于塞子400的可替代的锚定装置是在一个或两个或更多个远端锚状物,如图4中所示。导丝404穿过中心内腔410进入LAA内,并且粘附至LAA的远端壁部。在这种情况下,螺旋线408穿入LAA406的壁部内。在图5中示出了更紧密的细节,例如螺旋体502被示出为嵌入LAA壁部504内,而非一直通过心外膜表面506。
额外的锚定装置包括使用多个挂钩或倒钩或抓紧件,以抓住远端壁部和篮状物、马勒科(mallecot)、远端泡沫材料塞子以及镍钛诺线鸟巢,它们在LAA内敞开并向外推动壁部或者与LAA的突出部分接合。可期望设置塞子,然后作为第二步骤,与锚状物接合。一个这样的实施方式可包括大量的镍钛诺线,球状物或把手紧邻锚状物末端焊接。这些可与输送导管聚集在一起,然后在已确认理想的塞子位置时释放。
在图6中示出了一个实施方式的横截面,具有泡沫材料塞子600和左心房表面602和LAA表面610。ePTFE材料604封装泡沫材料塞子600,并且其开口端与附接结构(例如,在内管608之上的线、缝合物或管状褶皱606)连接。内管608可由植入级不锈钢(例如,304或316级)或钴-铬合金(例如,MP35n)制成,并且褶皱606可由退火的304或316不锈钢或钴-铬合金(例如,MP35n)制成。如果需要去除装置,那么这个褶皱也用作可捕捉的元件。
参照图6,管状ePTFE层604沿着装衬导丝内腔的内层612延伸,并且围绕左心房表面602向外翻转,以形成外层614。内层612的第一端616同心地设置在外层614的第二端618内。第一端616和第二端618夹在内管608与外部褶皱606之间。通过这种方式,可以这样的方式封装植入物,,即,呈现无缝左心房表面602并且保留导丝内腔与内管608的完整性。
在图7到图15中示出了装置的设置。为了封闭左心耳,必须首先从静脉系统进入左心房(LA)。一种方法是使用Brockenbrough型针来刺穿房间隔,以从右心房(RA)进入LA。执行基本的针穿刺技术,获得通常经由右股静脉的静脉通路。然后,经由预先放置在上腔静脉(SVC)内的0.025”或0.032”导丝跟踪Mullins护套和扩张器。通常使用荧光检查和超声心动图成像,例如,经食管超声心动图(TEE)或心脏内回声(ICE)。如果不使用回声,那么通常还将猪尾状导管放置在主动脉根部内,以限定主动脉瓣的位置,在使用回声时,不需要这个步骤。
一旦Mullins护套和扩张器位于SVC内,就去除导丝并且通过扩张器放置经房间隔针。该针包含管心针(stylette),以防止针在横穿末端时从扩张器内腔割下聚合物材料。一旦针接近扩张器末端,就去除管心针,并且针连接至支管并对齐。Mullins护套/扩张器组和针(定位在扩张器末端内)作为一个单元朝着RA缩回到SVC内。在系统沿着SVC的壁部向下撤回到RA内并定位在卵圆窝内时为优选的穿刺部位。
一旦观察到在卵圆窝内的合适位置,针就横穿卵圆窝前进到LA内。成功的经房间隔穿刺可通过回声、压力测量、O2饱和以及造影剂注射来确认。一旦确认针位置定位在LA内,护套和扩张器就可在其上前进到LA内。在一些情况下,用户将首先使导丝通过针进入LA内并在横穿之前进入上肺静脉(通常是左侧的)内。可替代的选择包括使用对于横穿非常厚的或肥厚性隔膜有用的射频经房间隔针,或者使用通过针放置的并用于初始穿刺的保险丝。
参照图8到15,导向导管802通过股静脉放置在心脏的右心房内并横穿心房内间隔进入左心房内,如上所述,并且定位在LAA孔804附近。通常具有0.035”直径的导丝902通过导向导管900放置并进入LAA904内。该导丝1002可具有附接在其远端的气囊1006,该气囊在LAA内充气并用作缓冲器以防止导向导管1100穿过LAA的壁部。然后,导向导管1100在导丝1108之外前进到LAA1104内。不透射线的标记1102用于荧光检查下的导向导管放置。然后,用推动器1202推动泡沫材料塞子1204通过导向导管1200,并且在图13中,该泡沫材料塞子被示出为缓慢离开导向导管1300,直到其完全展开,如图14中所示。然后,可使用远端气囊1408和导向导管1400,通过经由轴1412拉动气囊1408而使泡沫材料塞子向近端滑动,或者通过向远端推动导向导管1400而使泡沫材料塞子向远端滑动,将泡沫材料塞子1404位置调整到位。导丝还可在其中包含压力传感器,以监控LAA的密封并作出充分密封的确认。一旦用户对放置满意,就可注入粘合剂1514和/或展开机械锚状物,将塞子锚定至壁部。将导丝气囊1508放气,然后是导丝。在一可替代的实施方式中,可使用二元粘合系统,其中,该二元系统的一种成分粘合至覆盖泡沫材料塞子的外皮的外表面。第二种成分可注入到泡沫材料塞子与LAA的壁部之间的界面上,以使粘合仅仅发生在该界面上,使粘合剂成为栓塞的风险最小化。
推动塞子通过导向导管的整个长度的一可替代方案在于,塞子1204可最初放置在导向导管1200的远端,如图12中所示。导丝1210穿过塞子1204的中心,并且在这个模式中,推动器1202仅仅需要将塞子推动短距离,以使其展开到LAA内。
对于可替代的锚状物,可展开这些锚状物,断开并去除轴。断开机构可为几种类型中的任一种,例如,螺纹的、电解的分离或者本领域中已知的其他类型。
可替代的塞子构思包括泡沫材料和金属植入物的组合,如图16中所示。泡沫材料1600被设计为提供组织的内生并还提供金属支架1602在LAA的组织上的缓冲垫。塞子的近端表面被覆盖在ePTFE、聚酯或另一个抗血栓组织支架材料内,以促进以期望的孔径进行密封,从而促进增生。支架1602可由镍钛诺制成,以能够将其包装到10、12、14、16、18或20F输送导管内且膨胀至其期望的直径。可为编织、激光切割或线形成。根据期望的性能,可使用各种支架壁部模式中的任一种。如在本领域中所理解的,支架可为气囊可膨胀的支架或自膨胀式支架。在所示出的实施方式中,自膨胀式支架1602包括通过多个之字形支柱1612连接的多个近端顶点1608和远端顶点1610。孔1606允许导丝通过以用于输送。这个设计的有利之处在于,由塞子在LAA上施加的膨胀力可与泡沫材料特征分开控制。而且,可更容易将这个构思装在更小的几何结构内。
可替代地,泡沫材料塞子可由2个泡沫材料构成。一个较密实的中心部分用于提供力,并且外部较柔软的泡沫材料用于与组织不规则性接合。较柔软的泡沫材料还可位于近端和/或远端上,以促进取回。
在图17中示出了给泡沫材料塞子增加刚度的另一种方式,其中,在泡沫材料塞子1700内构成空腔1704,并且线圈1702可在近端1706从导向导管前进到空腔1704内。在线进入空腔内时,其膨胀至它的预定尺寸,并且在泡沫材料上径向向外地施加力。可在活的有机体内使用x射线引导来确定导丝的类型和数量,以检查泡沫材料在LAA内的径向膨胀。
代替在图17中示出的导丝,气囊可进入泡沫材料内并充气以提供径向力,而外部泡沫材料用于与组织不规则性和组织内生接合。在充气之后,气囊可与展开导管分离,并且抽出展开导管。气囊优选地设置有阀,以防止充气介质的逸出。充气可是各种介质中的任一种,该介质在第一可流动状态与第二硬化状态之间可转换,例如,通过在原地交联或聚合。
另一个LAA塞子在图18中被示出为弹簧状植入线1800,该植入线用泡沫材料1802覆盖以促进内生。植入物的近端表面用ePTFE或其他组织支架材料的薄片覆盖。这个植入物可伸展开以用于输送和释放到位。
代替使用泡沫材料,可将没有穿孔的低孔隙度外袋放置在LAA内,并且然后装有物质以提供径向膨胀。这个物质可为水凝胶、纤维素或聚醋酸乙烯酯。
代替需要使用单独的扩张装置以横跨隔膜,远端褶皱元件1902可以锥形的方式形成,以使其从导管1200的远端延伸并用作扩张末端,以在导管前进时扩张隔膜内的开口。参见图19。
一种可替代的塞子设计使用泡沫材料,例如,纤维素海绵材料,该泡沫材料被压紧并脱水,以使其可包装到导向导管内。这个泡沫材料2202可包装到导向导管内,如图22中所示。然后,泡沫材料塞子2202通过活塞2206从导向导管2204的远端前进到LAA内。塞子离开导向导管并打开成盘状2210。由于泡沫材料吸收血液内的液体,所以其长度膨胀,以形成填充LAA的柱体2220。压缩的纤维素材料的膨胀率可高达17:1,膨胀至压缩长度。
可有利的是,使用图23中的小倒钩2302,以进一步将塞子2204接合到LAA内。倒钩可为单向或双向,以抵抗近端或远端方向上的运动。这些倒钩嵌入泡沫材料塞子内,并且高度可为.1到1mm。可期望放置塞子,然后作为第二步骤,与倒钩接合。一个这样的实施方式可包括大量的镍钛诺倒钩线,球状物或把手紧邻倒钩末端焊接。这些可与输送导管一起聚集在封套内或缝合,然后在已确认理想的塞子位置时释放。
用于去除不适当工作的装置的一种方式是将取回缝合线2400可释放地附接至植入物,例如,附接至近端盖子2402,在图24中,该近端盖子也从近端穿过导向导管2404的整个长度。如果需去除装置,那么拉动缝合线2400的两端将外部覆盖物拉动到导向导管2404内,然后可从患者身上去除该装置。如果适当地放置装置,那么可切割并去除缝合线2400,将塞子留在原位。
已主要在经血管进入的背景下讨论了闭塞装置的展开。然而,本发明的植入物可通过直接外科进入或者各种微创进入路径(例如,颈静脉)可替代地展开。例如,可使用标准技术来准备和遮盖覆盖剑状软骨和相邻的肋软骨的区域。可给予局部麻醉剂,并且可形成皮肤切口,长度通常为大约2cm。经皮渗透在肋软骨下方经过,并且可将护套引入心包腔内。心包腔可用盐水冲洗,优选地用盐水-利多卡因溶液冲洗,以提供额外麻醉并降低刺激心脏的风险。之后,通过护套,并且通过穿过LAA的壁部形成的进入路径,可引入闭塞装置。之后,可使用本领域中理解的技术来实现壁部和进入路径的封闭。
根据期望的临床表现,本发明的任何LAA闭塞装置可提供有药物或生物活性剂,该药物或生物活性剂通过展开导管注入,或者浸渍在开孔泡沫材料内或涂覆在植入物上。如在本领域中所理解的,生物活性剂可在适合于特定制剂的输送时间段内洗脱或以其他方式从植入物释放到相邻组织内。
有用的生物活性剂可包括调节血栓形成的那些生物活性剂、促进细胞内生、穿生(throughgrowth)以及内皮化的那些生物活性剂,并且可能包括抵抗感染的那些生物活性剂。例如,可促进内皮细胞、平滑肌、纤维原细胞和/或其他细胞生长到植入物内的制剂包括胶原(I或II型)、肝素、胶原蛋白和肝素的组合、细胞外基质(ECM)、纤连蛋白、层粘连蛋白、玻连蛋白、多肽或其他生物分子,这些生物分子用作化学引诱物、分子MCP-1、VEGF、FGF-2和TGF-β、重组人类生长因子、和/或使用各种气体的等离子体处理。
抗血栓药通常可分成抗凝剂和抗血小板剂。抗凝剂包括凝血级联内的因子的抑制剂,并且包括肝素、肝素片段和部分、以及凝血酶抑制剂,包括水蛭素、水蛭素衍生物、达比加群、阿加曲班和比伐卢定以及X因子抑制剂,例如,低分子量肝素、利伐沙班、阿哌沙班。
抗血小板剂包括GP2b/3a抑制剂(例如,依替巴肽和阿昔单抗)、ADP受体激动剂(P2/Y12),包括噻吩并吡啶,例如,噻氯匹定、氯吡格雷、普拉格雷和替格瑞洛以及阿司匹林。其他制剂包括溶解剂,包括尿激酶和链激酶、它们的同系物、类似物、片段、其衍生物和药用盐以及前列腺素抑制剂。
抗生素剂可包括但不限于青霉素类、头孢菌素、万古霉素,氨基糖苷类、喹诺酮类、多粘菌素、红霉素、四环素、氯霉素、克林霉素、林可霉素、磺胺类、它们的同系物、类似物、衍生物、药用盐及其组合。
在图25A中示出了另一种锚定方式,其中,将泡沫材料塞子2500放入LAA内。远端螺旋引线(screwlead)2502前进并拧入LAA壁部内。导向件2506在近端拉动,如图25B中所示。在拉回这个导向件2506时,由镍钛诺制成的螺旋引线在泡沫材料塞子2500内部聚集成“鸟巢”2508或形成线圈。螺旋引线2502通过推动器2510远离导向导管2504推动,并且继续聚集成泡沫材料。然后去除导管系统2504、2506以及2510。
在图26中示出了将远端锚状物元件锚定至泡沫材料的另一种方式。两个倒钩引线2604附接至锚状物2602,以在泡沫材料塞子2600内前进到位时,倒钩2604插入泡沫材料塞子内。
可将如上所述的生物制剂加入植入物204内,并且可通过输送导管注入到近端盖子206与泡沫材料塞子204之间的空间内。这可用作储存器,以在初始植入期间使血栓形成减到最小,并且在装置植入之后减少对系统性抗凝血的需要。
电子压力传感器可嵌入泡沫材料塞子的近端内,该泡沫材料塞子可用于将LA压力传输至体外的远程接收器,以用于监控可用于监控心脏功能的LA压力。此外,心脏起搏器或自动减颤器可嵌入泡沫材料塞子内并电地附接至远端锚状物。药物输送储存器可嵌入为与LA连接,以用于如上所述的生物制剂的受控输送。
将在本文中引用的所有专利、专利申请以及公布的参考文献整体结合到本文中以作参考。应强调的是,本公开的上述实施方式仅仅是实现方式的可能实例,仅仅为了清楚地理解本公开的原理而阐述。在大体上不背离本公开的精神和原理的情况下,可对上述实施方式做出多种变化和修改。应理解的是,几个上面公开的以及其他特征和功能或其替代物可理想地组合成多个其他不同的系统或应用。与落在所附权利要求的范围内一样,旨在包含在本文中的所有这种修改和变化均在本公开的范围内。

Claims (28)

1.一种左心耳闭塞装置,包括:
能膨胀的开孔泡沫材料本体,具有:近端,用于在植入到所述左心耳内之后面向左心房;远端,用于在植入之后面向所述左心耳内部;以及侧壁;
外皮,覆盖至少所述本体的所述近端;以及
导丝内腔,延伸穿过所述本体;
其中,所述本体能压缩在具有不超过大约20F的内径的输送导管内,并且在从所述输送导管释放时能自膨胀至至少大约25mm的直径。
2.根据权利要求1所述的左心耳闭塞装置,其中,所述外皮包括ePTFE。
3.根据权利要求1所述的左心耳闭塞装置,其中,所述外皮遍及所述导丝内腔的长度延伸至所述远端。
4.根据权利要求3所述的左心耳闭塞装置,其中,所述外皮另外覆盖所述本体的所述远端的至少一部分。
5.根据权利要求1所述的左心耳闭塞装置,包括位于所述本体的所述侧壁上的至少一个组织内生表面。
6.根据权利要求5所述的左心耳闭塞装置,其中,所述组织内生表面包括所述泡沫材料的未由所述外皮覆盖的露出表面。
7.根据权利要求6所述的左心耳闭塞装置,其中,所述组织内生表面包括所述本体的所述侧壁的表面面积的至少大约20%。
8.根据权利要求1所述的左心耳闭塞装置,其中,所述外皮包括管状封套,所述管状封套具有第一端和第二端,并且所述封套延伸穿过所述导丝内腔并往回翻转到所述本体之上,以使所述第一端和所述第二端彼此连接,以封闭所述泡沫材料本体。
9.根据权利要求8所述的左心耳闭塞装置,其中,所述第一端和所述第二端通过褶皱彼此连接。
10.根据权利要求1所述的左心耳闭塞装置,进一步包括至少一个不透射线的标记。
11.根据权利要求10所述的左心耳闭塞装置,其中,所述不透射线的标记包括不透射线的线状物。
12.根据权利要求8所述的左心耳闭塞装置,包括位于所述外皮内的多个开口,以允许组织内生到所述泡沫材料内。
13.根据权利要求1所述的左心耳闭塞装置,其中,所述装置在不受约束的膨胀中包括大体上柱形的构造。
14.根据权利要求1所述的左心耳闭塞装置,进一步包括至少一个锚状物。
15.根据权利要求14所述的左心耳闭塞装置,其中,所述锚状物包括组织穿刺元件。
16.根据权利要求15所述的左心耳闭塞装置,其中,所述组织穿刺元件包括螺旋线。
17.一种左心耳封闭系统,包括:
输送导管,包括细长的柔性管状本体,所述管状本体具有近端和远端以及延伸穿过其中的至少一个内腔;
自膨胀式开孔泡沫材料本体,压缩在所述输送导管的所述远端内;所述本体包括覆盖所述本体的至少一部分的外皮以及延伸穿过所述本体的导丝;以及
轴向能移动的展开控制器,延伸穿过所述内腔,以用于从所述封闭系统的远端展开所述泡沫材料本体。
18.根据权利要求17所述的左心耳封闭系统,另外包括导丝,在所述导丝上具有充气气囊。
19.根据权利要求17所述的左心耳封闭系统,另外包括覆盖所述泡沫材料本体的至少一部分的外皮。
20.根据权利要求19所述的左心耳封闭系统,另外包括穿过所述外皮的至少一个开口,与允许组织内生到所述泡沫材料本体内。
21.根据权利要求17所述的左心耳封闭系统,另外包括延伸穿过所述管状本体的第二内腔。
22.根据权利要求21所述的左心耳封闭系统,其中,所述第二内腔被构造为将能流动介质输送至所述泡沫材料本体的表面。
23.根据权利要求22所述的左心耳封闭系统,其中,所述能流动介质包括粘合剂。
24.一种除去左心耳的方法,包括以下步骤:
提供具有细长的管状本体的输送导管,所述管状本体具有近端和远端;
使导丝前进到所述左心耳内;
使所述远端在所述导丝之外前进并进入所述左心耳内;
从所述远端展开植入物,
其中,所述植入物包括具有开孔泡沫材料和外层的自膨胀式本体,并且所述植入物符合所述左心耳的表面。
25.根据权利要求24所述的除去左心耳的方法,进一步包括在展开植入物的步骤之前为所述导丝上的气囊充气的步骤。
26.根据权利要求24所述的除去左心耳的方法,进一步包括将所述植入物锚定至相邻组织的步骤。
27.根据权利要求26所述的除去左心耳的方法,其中,所述锚定步骤包括使所述植入物粘附地结合至相邻组织。
28.根据权利要求26所述的除去左心耳的方法,其中,所述锚定步骤包括机械地接合所述相邻组织。
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