CN1852688A - 组织扩张装置及用于治疗介入的相关方法 - Google Patents
组织扩张装置及用于治疗介入的相关方法 Download PDFInfo
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Abstract
一种可以定位在弹性膜中的开口中或具有弹性侧壁的脉管的内腔中的装置。该装置在装置的平面内向外扩张或偏压限定开口或形成脉管侧壁的相对部分。向外的偏压沿着垂直于装置平面的方向向内拉动开口或侧壁的相对部分,并且并置或接触。
Description
本申请是基于美国临时专利No.60/471,555并要求其优先权,其全部公开内容在此作为参照引入。
技术领域
本发明涉及一种可以定位于弹性膜或具有弹性侧壁的脉管的内腔中的开口中的装置。该装置沿装置的平面向外扩张或偏压限定开口或形成脉管侧壁的相对部分。向外偏压沿垂直于装置平面的方向向内托拽开口或侧壁的相对部分,并达到并置或相接触。
背景技术
弹性膜,特别是诸如肌肉组织的活组织会经历缺损、失调或疾病,其中通过或在组织中形成不期望的开口或腔。具有弹性侧壁的弹性脉管可以在人体各处广泛地发现,并执行各种重要功能,例如,载运和分配血液到组织和运输来自消化和泌尿系统的废物。脉管可以使用括约肌来控制通过脉管物质的流量或者其可以采用单向瓣膜来防止流体倒流。瓣膜以及甚至是脉管本身会遭受抑制其正常发挥功能的能力的缺损、失调或异常的危害。重要肌肉组以及血管的各种失调的示例在下面以具体示例的方式介绍。
二尖瓣关闭不全
如图1所示,左房室或二尖瓣2为位于心脏10的左心房6与左心室8之间的孔4中的二尖齿(两小叶)瓣膜。富氧血液12从肺经肺静脉14流向左心房6,通过二尖瓣2并进入左心室8,在那里其泵送至主动脉16,用于进一步分配至身体。二尖瓣2具有彼此并置的小叶18和20,平行于并在小叶之间限定出瓣膜平面22。二尖瓣2为单向瓣膜,其小叶18和20垂直于瓣膜面22彼此分开地运动,从而允许流体进入左心室8,并响应在左心室8收缩从而同过主动脉16泵送血液时增大的压强彼此关闭(也称作接合)。对于健康的瓣膜,小叶18和20正常地彼此密合(接合),从而防止血液通过左心房6向肺倒流。然而,对于患病的二尖瓣,小叶会脱垂到左心房中,并允许血液倒流。
在心脏中的各个瓣膜中,二尖瓣最易受疾病攻击,并受房室瓣膜关闭不全的危害,由此二尖瓣密闭不完全。这允许血液在左心室的收缩下涌回到左心房中。患病的瓣膜小叶承受创伤和缩短,这是瓣膜关闭不全的一个原因。其它原因包括腱索(连接于小叶自由边防止脱垂的腱索)的不正常延长,以及与风湿性心脏病相关的小叶的僵化、变形或收缩。
由于二尖瓣更换的成功率很低,房室瓣膜关闭不全优选通过需要开心外科手术的二尖瓣修复来处理。这种处理极具侵入性,要求心脏停止,且患者靠心肺旁路维持生命并经常导致术后并发症。
静脉瓣关闭不全
如图2所示,人体循环系统的静脉24具有诸如也由两个小叶30和32构成的26和28的单向瓣膜系统,其工作从而通过防止心脏跳动期间血液倒退到末端而促进血流从末端回到心脏。静脉瓣26和28还配合允许肌肉运动帮助泵送血液从循环系统的静脉侧回到心脏。各个肌肉34的收缩使得静脉24收缩,迫使血液流出静脉,而静脉瓣26和28配合,其中瓣膜28打开的同时瓣膜26保持关闭,从而仅允许单向回流到心脏。
静脉受到与其瓣膜结构和功能缺陷相关的各种失调,诸如静脉瓣关闭不全。瓣膜关闭不全会导致静脉曲张,以及慢性静脉不足,其中瓣膜小叶变厚且收缩,使得其变得无法防止血液回流。这两种条件都会引起明显的不适,并会导致诸如水肿、红斑、皮炎、皮肤溃疡和蜂窝织炎的进一步的并发症。
动脉囊状动脉瘤
如图3所示,囊状动脉瘤36发生在身体中动脉40的分支38处,并且包括从动脉分支40之间的分叉点44向外延伸的袋状形式的动脉壁42。动脉瘤36具有直径较小的颈,其形成了与动脉40的接合点并由圆顶48盖住。在动脉瘤36的形成期间,动脉内弹性粘膜在颈46处消失,壁42减薄且削弱,而结缔组织取代了平滑肌细胞。动脉瘤易于在圆顶48处破裂并伴随出血。
脑血管囊状动脉瘤的破裂由于相关的高死亡率(破裂当天内10%,三个月内25%)和从最初的出血中幸存的人遭受的主要神经功能缺损而特别严重。
卵圆孔未闭
如图1所示,孔3为左右心房(分别为6和7)之间心脏的肌肉组织中的开口。此开口在出生前存在从而允许血液在母亲与胎儿之间引导。出生后,孔正常闭合从而分开心房,并允许血液通过婴儿的心脏泵送。卵圆孔未闭是一种心脏缺损,其中孔在出生后未能闭合,并允许血液在心房之间泄漏。这种缺损导致肺栓塞和中风的较大的风险。
心耳
图1B为沿图1中的线1B至1B截取的局部截面图,并示出了从左心房6邻近肺动脉9延伸的心耳5。心耳5近似于人拇指的尺寸并且未执行任何已知的有效功能。然而,它是血凝块的形成的原因,且被认为是90%与非风湿性心房纤维性颤动相关的中风或心律不齐的原因。中风的风险通过从左心房6隔开心耳5而极大的降低。
心房和心室间隔缺损
如图1C所示,心房间隔缺损是一种心脏缺损,其特征在于分别分开左右心房6和7的隔膜或壁15中的开口13。类似地,心室间隔缺损的特征在于分别分开左右心室8和11的隔膜19中的开口17。这种开口允许血液在心房或心室之间流动。
若未处理,心房间隔缺损在右心室上产生压力,而右心室相应地会扩大并弱化。肺会充血,且会导致肺动脉高压,而心律不齐和血凝块导致了中风。心室间隔缺损也在右心室上产生较大的压力,同样导致充血、肺动脉高压、血凝块、中风和心律不齐。
因此,需要一种装置和方法,其可以用于校正与肌肉组织以及具有可弯曲、弹性壁的脉管中开口相关的失调和异常,且其可以按照安全和最小侵入的方式应用,从而减小对患者的损伤并最小化术后并发症。
发明内容
本发明涉及一种可以定位在诸如肉组织的薄膜中的开口中或具有弹性侧壁的脉管的内腔内的偏压装置。该装置在装置的平面内向外彼此分开地偏压第一侧壁相对部分,同时沿着基本垂直于装置平面的方向彼此相向拉动第二相对侧壁部分。偏压装置通过导管插在开口或内腔内。在一个优选实施例中,该装置包括从公共端点延伸的一对弹性可弯曲的腿。腿可以在其中其彼此靠近从而滑动配合在导管内的第一构形与其中其彼此相对隔开的第二构形之间弹性形变。
第一和第二固定基础优选沿着每个腿远离公共端点沿长度方向定位。固定基础从多个连接于腿的丝状构件形成。固定基础限定出丝状构件之间的多个间隙。每个腿的固定基础在腿在脉管内处于第二构形时结合于第一相对侧壁部分,腿向外偏压第一相对侧壁部分并由此向内拉动第二相对侧壁部分。
在另一实施例中,本发明包括具有在第一和第二公共端点彼此连接的相对端点的一对弹性可弯曲腿,由此形成封闭的环。腿在其中腿彼此靠近从而滑动配合在导管内的第一构形与其中腿彼此相对隔开的第二构形之间弹性形变。
第一和第二固定基础优选在沿着腿的长度方向的环上彼此相对。固定基础也是由连接于腿的多个丝状构件形成,丝状构件限定出多个间隙。每个腿上的固定基础在腿在脉管内处于第二构形时结合于第一相对侧壁部分。腿向外偏压第一相对侧壁部分,并由此向内拉动第二相对侧壁部分。
根据本发明的装置还包括覆盖腿节并且也可以提供跨过腿节之间间隔的中心层的护罩。护罩优选由交织的丝状构件形成并提供促进活组织向内生长的母体,从而将装置固定于组织以及提供用于结缔组织与组织的基础从而永久地封闭脉管或开口。
本发明还包括通过使用根据本发明的偏压装置处理包括卵圆孔未闭、心耳、心房和心室间隔缺损、回流二尖瓣、静脉瓣泄漏、囊状动脉瘤或任何包括具有弹性侧壁的脉管的失调在内的缺损和失调的方法。该方法的步骤包括:
(A)在脉管或开口内定位偏压装置的腿,例如,在瓣膜的开口平面中,在囊状动脉瘤的颈部或在左右心房之间的开口中;以及
(B)偏压腿至彼此相对隔开,腿向外偏压脉管或开口的第一相对部分并由此彼此朝向地拉动地相对侧壁部分至并置,例如,瓣膜的小叶、动脉瘤的颈部或限定开口的相对侧部。
在处理瓣膜时,腿与瓣膜平面共面。在存在固定基础时,该方法还包括结合固定基础与开口或脉管的第一相对部分的进一步步骤,该装置位于瓣膜的开口平面内或囊状动脉瘤的颈部。
在一个方面中,本发明提供了一种用于偏压开口或脉管的相对壁部分至并置的装置。
在另一方面中,本发明提供了一种用于控制通过脉管的流体或其它物质的流量的装置。
在又一方面中,本发明提供了一种用于阻断通过脉管或开口的流体流量的装置。
在又一方面中,本发明提供了一种用于通过促进脉管的各部分或限定开口的壁部分之间的愈合反应而封闭开口或脉管的装置。
在又一方面中,本发明提供了一种可以通过侵入性最小的技术植入人体的装置。
在又一方面中,本发明提供了一种可以用于校正二尖瓣闭合不全的装置。
在又一方面中,本发明提供了一种可以用于校正静脉瓣闭合不全的装置。
在又一方面中,本发明提供了一种可以用于处理囊状动脉瘤的装置。
在又一方面中,本发明提供了一种可以用于校正卵圆孔未闭的装置。
在又一方面中,本发明提供了一种可以用于校正心房和心室间隔缺损的装置。
在另一方面中,本发明提供了一种可以用于闭合心耳的装置。
在又一方面中,本发明提供了一种偏压脉管或开口的相对壁部分至并置的方法。
在又一方面中,本发明提供了一种控制通过脉管的流体的流量的方法。
通过考察附图和对优选实施例的详细介绍,将使本发明的这些和其它目的及优点变得明显易懂。
附图说明
图1为透过人心脏的局部截面图,其强调出了左心房、左心室和控制血液在其间流动的二尖瓣;
图1A为沿图1的线1A-1A截取的截面图,并示出了位于二尖瓣平面内的根据本发明的偏压装置;
图1B为沿图1的线1B-1B截取的局部截面图,并示出了心耳;
图1C为人心脏的局部截面后视图,其显示出左右心室和心房;
图2为循环系统静脉的局部截面图;
图2A为沿图2的线2A-2A截取的截面图,并示出了位于静脉瓣内的根据本发明的偏压装置;
图3为具有囊状动脉瘤的分叉动脉的截面图;
图3A为沿图3的线3A-3A截取的截面图,并示出了位于囊状动脉瘤颈内的根据本发明的偏压装置;
图4至9为根据本发明的偏压装置的各个实施例的平面图;
图4A和5A分别为沿图4和5的断线圆圈4A和5A截取的放大尺寸的平面图,示出了该些装置的设计细节;
图10、12和14为根据本发明的偏压装置的各个实施例的平面图;
图11、13和15分别为沿图10、12和14的线11-11、13-13和15-15截取的偏压装置各个实施例的截面图;
图16为显示位于用于送入身体内脉管中的导管内的根据本发明的偏压装置的局部切开透视图;
图17为位于瓣膜内的根据本发明的偏压装置的透视截面图;
图18为位于心耳内的偏压装置的局部截面图;
图19为适用于通过导索传送的偏压装置的透视图;
图20为适用于通过导索传送的偏压装置的其它实施例的透视图;
图21和22为根据本发明的偏压装置的可去除的实施例的平面图;
图23和24示出了从韧性组织中取出的图21的装置;
图25和26为从管制备的偏压装置的其它实施例的透视图;
图27和28为从管制备的偏压装置的另一实施例的透视图;
图29为沿图28的线29-29截取的端面图;以及
图30为偏压装置另一实施例框架的透视图。
具体实施方式
图4示出了根据本发明的偏压装置50的实施例。偏压装置50包括从公共端点56延伸的一对弹性、可弯曲的腿52和54。腿52和54优选由不与活组织相排斥并具有相对高的屈服应力的金属形成,诸如镍钛诺,从而提供用于如下所述的该装置正常发挥功能的弹性偏压特性。诸如不锈钢、钛和埃尔吉洛伊非磁性合金的其它金属也是可行的。诸如聚酯、聚丙烯、以及聚四氟乙烯的的聚合物也可以用于形成腿。
固定基础58和60沿长度方向位于每个腿52和54远离公共端点56的部分。如图4A中详细示出,诸如58(以及60,未详细示出)的固定基础由丝状构件62形成,优选通过编织而相交织从而形成丝状构件62之间的空隙64。控制丝状构件62的细度和交织密度从而产生尺寸能够促进活组织交互生长到固定基础58和60中的间隙64,由此有机地连接装置50至其中插入该装置的脉管的侧壁。目前,60丹尼尔并以每英寸120根纬线编织的聚酯单丝是优选的,产生了0.004英寸量级尺寸横跨的间隙。也可以使用60丹尼尔的多丝聚酯形成更加柔顺的覆盖层。这在空间有限,诸如输送该装置期间,是有益的。
为进一步促进细胞生长,丝状构件可以涂以凝血酶、胶原质、透明质或者诸如促进血液凝固或惰性材料与活组织一体化的VEGf的生长因子宿主。另外,该装置的其余部分可涂以抗增殖药物,诸如Taxol、Rapamycin、Rapamume,从而起阻碍所有的增殖和在不期望的地方抑制活组织附着的作用。
从其长期有效用于人体植入物中的角度出发,聚酯对于丝状构件62而言是优选的。也可行的其它聚合物材料包括聚丙烯、聚四氟乙烯和尼龙。金属也可用于形成丝状构件,特别是由于其与人体组织的相容性和其高度的射线不透性,金是优选的。金丝,无论是构成丝状构件还是间隔在其间,起到了阻挡射线的标记的作用,便于使用荧光和X射线技术观察植入期间和植入后装置50的位置和取向。也可以向丝状构件62或以预定的图案选择性地向腿52和54施用金涂层66,便于明确和迅速地确定装置50的取向和位置。
丝状构件62可以焊接、粘结或编织于腿52和54,从而将固定基础58和60连接于腿。固定基础可以具有任何可行的形状,诸如图4中所示的扁平形状,或圆柱形,如图5和6中所示同心位于腿52和54周围的管状或套状形式。
为帮助装置50初始固定于活组织,钩子68可以位于腿52和54远离公共端点56的位置。优选地,钩子68与固定基础58和60共同位于每个腿52和54上,并且包括从腿向外延伸用于与其中植入装置50的脉管的侧壁接合的突出。与侧壁接合的钩子68将装置50固定原位,并允许其发挥作用并为固定基础58和60与脉管的活组织结合一体提供时间。
偏压装置50可以在其中腿52和54彼此位置靠近允许装置滑行通过导管内腔的第一构形与图4所示其中腿彼此相对隔开的第二构形之间弹性形变。优选地,腿52和54弹性偏压,从而在缺少外部施加的,诸如装置50在导管内时出现的限制时,确保间隔开的构型。这允许装置在弹性偏压力下张开并接合于脉管的侧壁,其中其在如下所述从导管上释放而定位。
图5示出了根据本发明的偏压装置的其它实施例70。装置70具有每个都由两节形成的腿52和54。在公共端点56连接在一起并彼此相对成角度取向的节72和74构成了腿52和54的各自的第一节。分别连接于节72和74的节76和78构成第二节。节76和78基本平行延伸,在腿处于所示的隔开的构型下时彼此隔开。如图5A所详细示出,装置70具有钩子68和诸如58的固定基础,其由丝状构件62形成,编或织成管状套并形成间隙64从而促进活细胞生长从而将装置70固定于活组织中。固定基础60类似并且不再详细示出。再参照图5,腿节72和74通过位于公共端点56的应力释放环80彼此连接。应力释放环80具有预定的曲率半径82,其利用其形状在腿节72和74变形为其中腿彼此靠近的构型时降低其中的应力。
图6示出了根据本发明的偏压装置的又一实施例84。取代在公共点56彼此一体地连接,腿52和54通过焊件86彼此焊接。
图7至9示出了根据本发明的装置的其它实施例88、90和92。图7所示的实施例88具有每个都分为三节的腿52和54。第一节94和96在第一公共端点98处彼此一体地连接。第二节100和102分别连接于第一节94和96的端部并彼此相对平行分开地取向。固定基础58和60以及钩子68优选位于第二腿节100和102上。第三腿节104和106分别连接于第二腿节100和102并在第二公共端点108处彼此一体地连接。借94、96、100、102、104和106共同形成封闭的环110。
图8所示的实施例90具有成角度取向的腿节112和114,彼此连接于公共端点116。具有预定半径120的应力释放环118位于公共端点116并连接腿节112和114。平行取向的腿节122和124分别连接于成角度取向的腿节112和114的端部。固定基础126和128分别位于平行取向的腿节122和124上,而钩子130与固定基础位置相同。另一对成角度取向的腿节132和134分别从平行取向的节122和124延伸,成角度取向的腿节132和134通过例如焊接在另一公共端136彼此连接从而形成封闭的环138。
图9示出了根据本发明的装置的另一实施例92。实施例90包括成角度取向的腿节140和142,其通过例如焊接在公共端点144彼此连接。平行取向的腿节146和148分别从成角度的腿节140和142延伸。固定基础150和152位于平行取向的腿节146和148上,连同处于相同位置的钩子154。第二成角度取向的腿节156和158分别从平行取向的腿节146和148延伸并在第二公共端点160彼此连接,形成封闭的环162。
如图10至15所示,将各个实施例188、190和192所示的护罩设置于偏压装置周围是有益的,具体形式,护罩的构造和形状依赖于偏压装置要起的具体作用。举例而言,偏压装置实施例88、90和92分别示为具有护罩实施例188、190和192,应理解,可以将任意护罩实施例用于任意装置实施例,包括实施例50、70和84(见图4至6),以及未具体示出的任何装置实施例。
护罩188、190和192优选包括交织而成的丝状构件194,其围绕在偏压装置周围。丝状构件的交织可以通过织、结或编。丝状构件也可以包括无纺构造,诸如毡。大范围多孔的连续弹性膜也可用于形成护罩。
在要植入活组织中时,丝状构件包括生物相容的材料,诸如聚酯、聚四氟乙烯、尼龙、聚丙烯、聚乙烯,并且也可以包括金属,诸如不锈钢,以及形状记忆金属,诸如镍钛诺、钛和不锈钢合金,诸如chronochrome、埃尔吉洛伊非磁性合金(eligiloy)和MP35N,其在体内加热时可以膨胀为预定形状。诸如聚乳酸、聚羟基乙酸和HCA的生物吸收材料也可作为构成护罩的丝状构件。类似地,用于连续薄膜护罩备选材料包括泡沫聚四氟乙烯,以及硅树脂薄膜、聚氨酯和激光槽管(如下所述)。
材料的选择通过护罩的功能决定。例如,若护罩用于促进活组织的愈合和向内生长,从而永久地封闭诸如心耳的腔、或诸如隔膜缺损的组织壁中的开口、或诸如动脉瘤基部的血管的脉管,则优选材料为聚酯,其促进积极愈合反应。丝状构件也可涂以化合物,诸如凝血酶、胶原质、透明质或上述促进凝结和细胞生长的增长因子。
然而,若护罩作为限制装置,控制通过例如脉管的流量,则诸如聚四氟乙烯的材料是优选的,因为其将不允许外来物质积累并形成脉管的阻碍。
图10示出了偏压装置88(也见图7)上护罩188的实施例。护罩188通过在腿节94至106周围环接丝状构件194连接。腿节也可以与丝状构件交编或交织。由图11可以最好地示出,单中心层196跨过由腿节94至106限定的环110。护罩188示范的单中心层实施例在要封闭开口或脉管时是优选的,因为单中心层196提供了在通过偏压装置88依靠单中心层196并置时促进将开口或脉管的侧面连接在一起的活组织相互生长的母体。
图12示出了位于偏压装置90(也见图8)上的另一护罩实施例190。护罩190优选由织、编或结成围绕腿节112、114、122、124、132和134的管状护套198的丝状构件194形成。图13所示的截面图最好地示出了护套198与腿节之间的关系。在矫正血管中关闭不全瓣膜时使用管状护套形式的护罩190是有利的。若偏压装置190是暴露的,则暴露于血流的腿节将成为血凝块形成的处所,其将脱离和会导致中风。护罩190提供了血细胞可以将自身附着其上的母体,并且最后将偏压装置封闭在活组织内。由此封闭,装置的腿不会再造成凝血反应,由此最小化或甚至是消除潜在的血凝块和中风。
图14示出了护罩192,包括形状基本配合的囊200,其中密封了偏压装置92(也见图9)。囊200跨过由形成偏压装置92的腿节限定的封闭的环162。由图15最好地示出,囊200呈现为两个中心层202和204,其相互隔开地位于装置92的相对侧面上。
使用中的该装置的示范介绍
下面将提供示出使用中根据本发明的装置的各个示例。应理解,所示的特定实施例或其采用的特定应用并未提出或意味着任何限制。
示例1
二尖瓣修复
图16示出了容纳在护套198形式的护罩190内的偏压装置90,其处于弹性形变构型,其中腿节112、122和132靠近腿节114、124和134,允许装置90配合在导管166的内腔164内并通过其中滑动。装置90弹性偏压从而呈现图8所示的构型,其中腿节112、114和132相对于腿节114、124和134隔开。从导管166释放后,装置90将呈现此隔开的构型,导管提供限制力从而保持腿节处于弹性形变、靠近的构型。装置的这些弹性特性允许其经导管通过脉管系统传输至其待植入的位置而无需创伤性、侵入式的外科手术。根据本发明的装置随后通过已知的方法从导管释放,例如,使用顶杆165,从而呈现其隔开的构型并偏压其位于其中的脉管的弹性侧壁。
图1、1A和17示出了位于心脏10内的装置90,从而修复回流二尖瓣2。装置90展开为其腿节112、114、122、124、132和134基本与瓣膜2的平面22共面。“瓣膜平面”的含义在图17中最好地示出,其示出小叶18和20并置的二尖齿二尖瓣2的透视图,虚线示出的平面22平行于小叶。
如图1A中最好地示出,装置90定位为使得固定基础126和128和钩子130结合于小叶18和20从其延伸的肌肉环带172的相对部分168和170。装置90的尺寸确定为并设置有弹性率(spring rate),使得其在瓣膜的平面22内向外偏压相对的环部168和170。因为二尖瓣2作用为具有弹性侧壁的脉管,相对环部168和170的向外偏压沿着垂直于图17所示瓣膜的平面22的方向朝向彼此向内拉小叶18和20。由于小叶18和20彼此紧密靠近,其将在施加来自左心室8的背压时有效密封。由此,血液将受迫通过主动脉16(见图1)并到身体的其余部分,而不会由于无法正常起效的二尖瓣2而通过左心房6回流到肺。对于二尖瓣修复,装置90的尺寸可以在约1至2英寸长的范围,并且具有30至40mm的扩展后的直径。描述装置将利用其拉伸二尖瓣的有效偏压力的弹性率范围在2至3lbs/英寸之间。弹性率通过构成装置的特定材料的弹性模量、以及通过其截面形状和面积确定的腿的截面惯性矩来确定。注意,护套200通过允许血细胞向内生长最终封闭装置90而防止装置成为凝块形成的处所。
示例2
静脉瓣修复
图2和2A示出了植入静脉24中的根据本发明的偏压装置90,从而实现失禁静脉瓣26的有效修复。类似于二尖瓣的修复,装置90从导管166(见图10)展开于静脉24内,其腿节与瓣膜26的平面22共面。如图2A所示,静脉24在瓣膜小叶30和32处的相对部分174和176通过固定基础126和128结合从而向外偏压相对的静脉部分,由此沿着垂直于瓣膜26的平面22的方向向内彼此朝向地拉动瓣膜小叶30和32。如图2所示,通过紧密靠近地定位小叶30和32,在通过肌肉34在静脉24内施加箭头175所指的背压时,其更可能有效地密封。通过修复否则失禁的瓣膜26,血液受迫沿箭头177所指的期望方向流经静脉24。
示例3
囊状动脉瘤的修复
图3和3A示出了位于囊状动脉瘤36中的装置90。装置90从导管展开至其固定基础126和128位于动脉瘤36的颈46的位置。固定基础126和128与颈46的相对部分178和180结合并将其向外偏压,由此垂直于装置90的平面彼此朝向地拉相对的颈部182和184。装置90在动脉瘤36的颈46上的偏压作用如图3所示地限制了颈并降低了进入动脉瘤中的血流,降低了圆顶48上压强并在颈46上提供了促进凝结并最终封闭动脉瘤的滞留区域,由此防止其破裂。优选地,装置90具有包括单中心层196的护罩实施例188。中心层196提供了来自相对颈部182,184的细胞可以生长从而永久封闭动脉瘤36并将其与循环系统隔离开的母体。
护罩的优选材料包括聚酯的单丝和多丝纱,其将促进积极愈合效果,以及聚丙烯、聚四氟乙烯和泡沫聚四氟乙烯。由钛、镍钛诺、不锈钢、铂和埃尔吉洛伊非磁性合金构成的金属丝也是可用的。由硅树脂和聚氨酯制成的无纺薄膜,特别是槽管形式的,对于本发明也是可以的。根据需要,护罩可以涂以诸如凝血酶、胶原质、透明质和增长因子的化合物,从而促进组织向内生长或血液凝固,或诸如Taxol、Rapamycin和Rapamune的抗增殖药物从而防止组织向内生长或抑制组织附着。
示例4
心耳闭合
图1B示出了邻近肺动脉9的位于左心房6中的心耳5。为实现此心耳5的闭合,可以在心耳5内插入偏压装置,例如88,如图18所示,从而使心耳5塌缩到心房6内并消除其作为导致中风的血块的潜在来源。偏压装置88可以经导管插入,由此提供一种用于校正此心脏缺损的侵入性最小的技术。
示例5
卵圆孔未闭和间隔缺损的处理
允许异常血流的包括心脏肌肉组织中的开口在内的缺损诸如卵圆孔未闭(见图1中的3)和心房及心室间隔缺损(图1C中的13和17),其可以通过向开口中插入根据本发明的偏压装置来处理。利用导管插入,偏压装置在从其中释放后展开,或者通过腿节的弹性偏压或者通过在加热的基础上展开成预定形状的形状记忆金属的特定性质。偏压装置拉伸肌肉组织,使相对的部分并置从而彼此接触,或接触组织可以向其中生长的护罩层的相对侧面从而永久地封闭开口。
示例6
流体流动控制
传导血液以外的流体的脉管,诸如食道、尿道等也会经历失调。例如,胃食管反流的一个原因在于食管与胃之间的下食管括约肌的闲置伸缩性的下降。下食管括约肌允许胃酸流入并损伤食管,导致熟知的“烧心”的不适。渗漏的食管可以通过在其直径内设置根据本发明的偏压装置来绷紧,从而将其拉伸并减小闲置开口的尺寸从而防止酸回流。
膀胱失禁可以通过在尿道括约肌内设置偏压装置来处理。装置的刚性将调校从而允许尿液按照受控的方式流动而防止不期望的泄漏。
节育法也可以使用根据本发明的偏压装置。对于女性,偏压装置可以植入在输卵管内从而将其闭合并由此防止卵子通过到达子宫。植入物将比输卵管结扎更小侵入性并且由于认为在一定的条件下可以取出偏压装置还是可逆的。
类似地,在输精管中设置偏压装置将有效阻挡来自男性睾丸的精子通道。
上述和在附图中示出的偏压装置的各个实施例在便利时可以通过导线传送。图19和20示出了用于在导线206上传送的实施例90的示例。如图19所示,实施例90具有凸耳208,偏离装置的中线安装从而与导线206结合并允许装置在其上滑动,用于精确和方便地定位。在图20中,装置90具有孔210,在此示例中,其沿着装置的中线定位,孔210容纳导线20并允许装置沿着由导线限定的路线做精确的滑动运动。
根据本发明的装置还可以用于可拆装地定位在弹性侧壁脉管内或软组织中的开口内。图21和22示出了根据本发明的可拆卸装置的实施例212。装置212优选包括两个独立的部件,其可以例如由上部214和下部216成形。上部214具有带对应的孔220的节218,孔220用于容纳从下部216延伸的中间件节222。节222可以通过摩擦或粘合,或通过互锁或棘爪装置固定在孔220内,从而保持上下部分214和216在一起,如图21所示,但允许其通过施加足够的预定力而彼此分开,如图22所示。装置212优选在每个上下节214和216上具有倒钩224。对于可拆卸实施例,倒钩224彼此朝向相对于装置212向内指向。如图23所示,这种倒钩取向防止了装置212在脉管226或其它软组织内活动,只要上部214和下部216两者保持在一起且两部分沿相同的方向运动。然而,如图24所示,若上下部分214和216沿相反方向彼此分开地运动,如箭头228所示,其将导致彼此分开,则倒钩224不再提供对于运动的阻力,但因为其向内成角度的取向,将避开软组织并允许上下部分彼此分开,并从其最初植入的脉管或组织中取出。
或者,根据本发明的偏压装置可以有薄壁管制成。优选地,该管包括形状记忆金属,诸如镍钛诺和埃尔吉洛伊非磁性合金,而其它具有较大弹性和高屈服力的金属,诸如不锈钢和钛也是可行的。
图25和26示出了从薄壁管232制备的偏压装置的实施例230。如图25所示,槽234形成在管壁236中,彼此相对。槽可以通过激光切割,以及通过使用锯或刀片形成。还透过管壁236形成了彼此相对并沿着管周围的圆周距槽234的90度处的V形切口238。图26所示的装置230通过向外延展管232从而开槽234而形成,槽间的管壁236形成用于结合和偏压或扩张其植入其中的脉管或组织的节240。管232的延展优选通过施加热量从而偏压装置至图26所示的延展形状而在心轴上进行。由于形成管的材料的柔韧性、弹性属性,装置可以充分形变回到管状形状,从而在导管内滑动并随后在从导管中释放后扩展成图26所示的形状。或者,装置可以具有图25的管状形状作为其名义上的形状,且在通过充气囊植入后屈服地向外展开。V形切口238形成从节240向外延伸的钩子242,钩子可以与软组织结合从而将装置固定在前面实施例所述的位置。利用由管壁236限定的孔244,管可以方便地通过导线206引导用于精确定位。
图27和28示出了从管248形成的装置246的另一实施例。管248具有多个槽250,优选不对称地形成在管壁252的相对侧面上,即,槽不会在管周围沿圆周分布。槽的不对称分布迫使管展开成平坦形状,如图29中最好地示出,而管的相对带槽侧面252a在靠近带槽区域的区域252b拉开时拉到一起。在管248展开时,槽250可以排列、相互连接和成形从而形成特定的复杂图案254(图28所示)。图案可以形成促进细胞向内生长的母体,或者可以设置提供用于偏压脉管壁或向外开口的组织的刚性和强度的栅格结构。
图30A至B示出了特别适于处理卵圆孔未闭的优选装置300。如图30A所示,装置300包括由多个腿节构成的框架305。第一组成角度取向的腿节310和312弹性连接于第一轴环部件314。第二组腿节316和318连接于腿节310和312的端部并由其向外成一定角度。腿节310和312连接于第三组腿节320和322,其从与腿节316和318的连接点成一定角度并弹性连接于第二轴环部件324。设置延伸超出框架305的左心房锚326和右心房锚328从而固定装置在由卵圆孔限定的开口内。在优选实施例中,如图30A所示,左心房锚326分别连接于腿节316和318并与其共同延伸,沿着第一轴环部件314的方向,并包括形成在其靠近第一轴环部件314的端部的钩部317。右心房锚连接于腿节320和322远离第二轴环部件324的端部并与其共同延伸。左心房锚326和右心房锚328两者都延伸超出框架305。在镍钛诺线(未示出)上,左心房锚优选由钽线圈329覆盖,如图31A至31B所示,从而改善射线可见度。另外,第一轴环部件314和第二轴环部件324优选包括钽标记或钽涂层从而改善射线可见度。
在其它实施例中,如图30B所示,腿节310和312连接于距离带钩端部较远的左心房锚326的一部分,其又通过例如焊接连接至腿节320和322,靠近右心房锚328向外延伸的端部。
在一个实施例中,偏压装置的框架305覆盖有护罩332,如图30C所示,其可能的制造和构造在上面介绍。护罩应促进或组织的愈合和向内生长从而永久密封腔。优选材料为聚酯,其促进积极愈合反应。如上所述,丝状构件也可涂以诸如凝血酶、胶原质、透明质或前述生长因子的化合物,其促进凝固和细胞生长。
偏压装置300可以弹性形变从而允许该装置通过导管的内腔滑动。在例如腿节316和318彼此朝向偏压时,随着框架305的宽度变窄,第一轴环部件314和第二轴环部件324沿着相反的方向受迫。随着偏压装置300从导管中移出,框架305扩展至其预定的宽度。为便于装置300的放置,导线330可以通过第一轴环部件314和第二轴环部件324的中心送入。
在处理例如卵圆孔未闭时,其中插入装置300的导管的远端从右心房和左心房的方向延伸,通过由卵圆孔限定的开口,使得导管的远端延伸得稍微进入左心房。使用例如顶管,将装置300推出导管的远端,并控制使得心房锚314的钩部317与围绕开口的左心房的组织结合,并使得右锚324受迫靠近邻近开口的右心室组织。随着装置300从开口中移出,框架305的宽度将扩展从而扩张围绕该开口的组织。
根据本发明的偏压装置提供了一种通用制品,用于以侵入性最小的外科技术修复组织中开口、具有弹性侧壁的脉管中的异常、以及控制通过该脉管的流体的流量,并且可以用于治疗或修复循环系统以及身体中其它系统的失调,由此避免对患者的不必要的损伤。
Claims (86)
1.一种偏压装置,可以定位在由弹性侧壁限定的身体开口内,所述偏压装置具有第一折叠构型,从而便于通过导管插入并可以在从所述导管中释放出来时朝向第二构形自动扩展,所述偏压装置包括:
至少第一和第二侧壁结合部件,用于在所述偏压装置展开期间分别结合并向外扩展所述开口相对侧面的所述侧壁的相对部分;以及
至少一个可扩展并且可缩小的连接部件,连接在所述第一与第二侧壁结合部件之间,所述连接部件形成为收缩而彼此靠近地定位所述侧壁结合部件,用于插入导管,并在从所述导管释放所述偏压装置后扩展从而分离地移动所述侧壁结合部件并沿着基本与所述开口相对侧面上所述侧壁的所述相对部分相同的平面接触并随后扩展所述相对的侧壁。
2.如权利要求1所述的偏压装置,其中所述侧壁结合部件设置有固定机构从而结合侧壁和连接侧壁结合部件至侧壁。
3.如权利要求2所述的偏压装置,其中所述固定机构为通过交织多个丝状构件形成的固定基础从而在所述丝状构件之间限定多个间隙。
4.如权利要求3所述的偏压装置,其中所述多个间隙的尺寸确定为促进活组织向固定基础上交互生长。
5.如权利要求3所述的偏压装置,其中所述丝状构件涂以凝血酶、胶原质、透明质和宿主增长因子中的至少一种。
6.如权利要求2所述的偏压装置,其中该装置固定机构以外的部分涂以抗增殖药。
7.如权利要求6所述的偏压装置,其中所述抗增殖药为Taxol、Rapamycin、以及Rapamune中的至少一种。
8.如权利要求3所述的偏压装置,其中丝状构件包括聚合物。
9.如权利要求3所述的偏压装置,其中丝状构件包括金属。
10.如权利要求8所述的偏压装置,其中所述聚合物为聚酯、聚丙烯、聚四氟乙烯和尼龙中的至少一种。
11.如权利要求9所述的偏压装置,其中所述金属为金。
12.如权利要求2所述的偏压装置,其中固定机构通过至少一个或更多个从每个侧壁结合部件向外延伸的钩子形成。
13.如权利要求1所述的偏压装置,其中所述第一和第二侧壁结合部件每个包括用于结合所述侧壁的伸长的腿节,所述至少一个连接部件保持第一和第二侧壁部件处于基本共面的关系。
14.如权利要求1所述的偏压装置,其中护罩围绕第一和第二侧壁结合部件以及连接部件的至少一个的至少一部分。
15.如权利要求1所述的偏压装置,其中护罩包括其中密封偏压装置的形状基本配合的囊。
16.如权利要求14所述的偏压装置,其中所述护罩由聚合物形成。
17.如权利要求14所述的偏压装置,其中所述护罩由金属形成。
18.如权利要求16所述的偏压装置,其中所述聚合物为聚酯、聚四氟乙烯、尼龙、聚丙烯、聚乙烯和硅树脂中的至少一种。
19.如权利要求17所述的偏压装置,其中所述金属为形状记忆金属或不锈钢合金中的至少一种。
20.如权利要求14所述的偏压装置,其中护罩涂以凝血酶、胶原质、透明质或宿主增长因子中的至少一种。
21.如权利要求1所述的偏压装置,其中所述第一和第二侧壁结合部件共面。
22.如权利要求1所述的偏压装置,其中所述连接部件为应力释放环。
23.如权利要求22所述的偏压装置,其中所述应力释放环具有预定的曲率半径。
24.如权利要求3所述的偏压装置,其中所述丝状构件包括射线不透明的材料。
25.如权利要求24所述的偏压装置,其中所述射线不透明的材料从金、钡和钛构成的组中选取。
26.如权利要求3所述的偏压装置,其中所述丝状构件具有射线不透明的涂层。
27.如权利要求3所述的偏压装置,其中每个固定基础的所述丝状构件编在一起从而形成与所述第一和第二侧壁结合部件共轴定位的管。
28.一种偏压装置,可以定位在由弹性侧壁限定的身体开口内,所述偏压装置具有第一折叠构型,从而便于通过导管插入并可以在从所述导管中释放出来时朝向第二构形自动扩展,所述偏压装置包括:
至少一个连接于第一轴环的腿节;
至少一个连接于第二轴环的腿节;
第一固定部件;以及
第二固定部件。
29.如权利要求28所述的装置,其中导线可以通过所述第一和第二轴环插入。
30.如权利要求28所述的装置,其中所述第一和第二轴环的至少一个包括射线不透明的材料。
31.如权利要求30所述的装置,其中所述射线不透明的材料从金、钡和钛构成的组中选取。
32.如权利要求28所述的装置,其中所述第一固定部件和所述第二固定部件中的至少一个为通过交织多个丝状构件形成的固定基础从而在所述丝状构件之间形成多个间隙。
33.如权利要求32所述的装置,其中所述丝状构件涂以凝血酶、胶原质、透明质或宿主增长因子中的至少一种。
34.如权利要求28所述的装置,其中该装置的所述第一固定部件和第二固定部件以外的部分涂以抗增殖药。
35.如权利要求34所述的装置,其中所述抗增殖药为Taxol、Rapamycin、以及Rapamune中的至少一种。
36.如权利要求32所述的装置,其中丝状构件包括聚合物。
37.如权利要求32所述的装置,其中丝状构件包括金属。
38.如权利要求36所述的装置,其中所述聚合物为聚酯、聚丙烯、聚四氟乙烯和尼龙中的至少一种。
39.如权利要求37所述的装置,其中所述金属为金。
40.如权利要求28所述的装置,其中所述第一固定部件和第二固定部件中的至少一个的至少一部分包括组织结合钩。
41.如权利要求28所述的装置,其中所述第一固定部件结合于左心房。
42.如权利要求28所述的装置,其中所述第二固定部件结合于所述弹性侧壁。
43.如权利要求28所述的装置,还包括护罩。
44.如权利要求43所述的装置,其中所述护罩包围所述腿节的至少一部分。
45.如权利要求43所述的装置,其中所述护罩由聚合物形成。
46.如权利要求43所述的偏压装置,其中所述护罩由金属形成。
47.如权利要求45所述的偏压装置,其中所述聚合物为聚酯、聚四氟乙烯、尼龙、聚丙烯、聚乙烯和硅树脂中的至少一种。
48.如权利要求46所述的偏压装置,其中所述金属为形状记忆金属和不锈钢合金中的至少一种。
49.如权利要求43所述的偏压装置,其中护罩涂以凝血酶、胶原质、透明质或宿主增长因子中的至少一种。
50.如权利要求28所述的偏压装置,其中至少所述第一锚的至少一部分由钽线圈覆盖。
51.一种组织扩张方法,包括:
在由弹性侧壁限定的开口中定位偏压装置,其中偏压装置包括至少第一和第二侧壁结合部件,以及至少一个连接在第一和第二侧壁结合部件之间的可扩展且可收缩的连接部件;以及
在该装置的平面中彼此向外偏压第一相对侧壁部分,同时沿着基本垂直于装置平面的方向彼此朝向地拉动第二相对侧壁部分并且成并置或接触。
52.如权利要求51所述的方法,还包括在所述开口内固定所述偏压装置的步骤。
53.如权利要求51所述的方法,其中所述弹性侧壁为瓣膜的侧壁。
54.如权利要求53所述的方法,其中所述瓣膜为二尖瓣。
55.如权利要求53所述的方法,其中所述瓣膜为静脉瓣。
56.如权利要求51所述的方法,其中所述弹性侧壁为动脉瘤的侧壁。
57.如权利要求56所述的方法,其中所述动脉瘤为囊状动脉瘤。
58.如权利要求51所述的方法,其中所述弹性侧壁为心耳的侧壁。
59.如权利要求51所述的方法,其中所述弹性侧壁为卵圆孔的侧壁。
60.如权利要求51所述的方法,其中所述弹性侧壁为食管侧壁。
61.如权利要求51所述的方法,其中所述弹性侧壁为尿道的侧壁。
62.如权利要求51所述的方法,其中所述弹性侧壁为胃的侧壁。
63.如权利要求51所述的方法,其中所述弹性侧壁为输卵管的侧壁。
64.如权利要求51所述的方法,其中弹性侧壁为输精管的侧壁。
65.如权利要求51所述的方法,其中弹性侧壁包括肌肉组织、上皮组织、神经组织、以及结缔组织中的至少一种。
66.如权利要求51所述的方法,其中所述装置使用导管定位在所述开口内。
67.一种封闭由弹性侧壁限定的身体开口的方法,包括:
接触身体开口的相对侧面上的侧壁的第一和第二部分;
彼此远离地同时扩展所述侧壁所述第一和第二相对部分;
持续所述第一和第二侧壁部分的扩展从而拉动所述侧壁的所述第一和第二部分之间的侧壁的相对部分到一起从而封闭所述身体开口。
68.如权利要求67所述的方法,其包括在所述侧壁的所述第一和第二相对部分之间延伸的平面内跨过所述身体开口设置丝材料的网;以及
拉动所述侧壁的所述第一和第二相对部分之间的所述侧壁的所述相对部分到一起与所述丝材料的网相接触。
69.如权利要求67所述的方法,其中所述弹性侧壁为瓣膜的侧壁。
70.如权利要求69所述的方法,其中所述瓣膜为二尖瓣。
71.如权利要求69所述的方法,其中所述瓣膜为静脉瓣。
72.如权利要求67所述的方法,其中所述弹性侧壁为动脉瘤的侧壁。
73.如权利要求67所述的方法,其中所述动脉瘤为囊状动脉瘤。
74.如权利要求67所述的方法,其中所述弹性侧壁为心耳的侧壁。
75.如权利要求67所述的方法,其中所述弹性侧壁为卵圆孔的侧壁。
76.如权利要求67所述的方法,其中所述弹性侧壁为食管的侧壁。
77.如权利要求67所述的方法,其中所述弹性侧壁为尿道的侧壁。
78.如权利要求67所述的方法,其中所述弹性侧壁为胃的侧壁。
79.如权利要求67所述的方法,其中所述弹性侧壁为输卵管的侧壁。
80.如权利要求67所述的方法,其中弹性侧壁为输精管的侧壁。
81.如权利要求67所述的方法,其中弹性侧壁阿伯扩肌肉组织、上皮组织、神经组织、以及结缔组织中的至少一种。
82.如权利要求67所述的方法,其中所述装置使用导管定位在所述开口内。
83.一种封闭位于由弹性侧壁限定的开口内的身体瓣膜的方法,其中瓣膜通过一对分别从所述侧壁的第一和第二相对部分延伸从而在其间限定开口平面的相对瓣膜小叶形成,包括:
在所述对相对的瓣膜小叶之间的所述开口平面中设置丝材料网;
在与所述开口平面基本共同延伸的平面内接触分别位于所述瓣膜小叶相对侧面上的所述侧壁的两个相对部分;
同时彼此分开地向外扩展所述侧壁的所述两个相对部分;以及
持续所述扩展从而朝向所述开口平面向内拉动所述侧壁的所述第一和第二相对部分,使所述相对的瓣膜小叶一同靠近所述丝网。
84.如权利要求83所述的方法,其中所述瓣膜为单向瓣膜。
85.如权利要求83所述的方法,其中所述瓣膜为二尖瓣。
86.如权利要求83所述的方法,其中所述瓣膜为静脉瓣。
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2004
- 2004-05-19 WO PCT/US2004/015734 patent/WO2004103209A2/en active Application Filing
- 2004-05-19 JP JP2006533224A patent/JP4547381B2/ja not_active Expired - Fee Related
- 2004-05-19 CN CNA2004800208930A patent/CN1852688A/zh active Pending
- 2004-05-19 EP EP04752709A patent/EP1648340B1/en not_active Expired - Fee Related
- 2004-05-19 EP EP10002127A patent/EP2191790A3/en not_active Withdrawn
- 2004-05-19 DE DE602004025814T patent/DE602004025814D1/de active Active
- 2004-05-19 US US10/847,909 patent/US7122043B2/en not_active Expired - Fee Related
-
2005
- 2005-07-19 US US11/184,069 patent/US8758395B2/en not_active Expired - Fee Related
-
2006
- 2006-01-03 US US11/323,640 patent/US7648532B2/en not_active Expired - Fee Related
-
2009
- 2009-05-08 US US12/463,296 patent/US20090275976A1/en not_active Abandoned
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2010
- 2010-03-10 JP JP2010052901A patent/JP4940318B2/ja not_active Expired - Fee Related
Cited By (3)
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WO2014127641A1 (zh) * | 2013-02-19 | 2014-08-28 | 湖南埃普特医疗器械有限公司 | 一种左心耳封堵装置以及一种输送系统 |
US9763666B2 (en) | 2013-02-19 | 2017-09-19 | Apt Medical Inc. | Left atrial appendage plugging device and delivery system |
CN113244031A (zh) * | 2021-07-15 | 2021-08-13 | 上海御瓣医疗科技有限公司 | 一种医用自锁结构 |
Also Published As
Publication number | Publication date |
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EP1648340A2 (en) | 2006-04-26 |
DE602004025814D1 (de) | 2010-04-15 |
EP1648340A4 (en) | 2007-12-19 |
EP2191790A3 (en) | 2012-10-17 |
JP4547381B2 (ja) | 2010-09-22 |
WO2004103209A2 (en) | 2004-12-02 |
US7122043B2 (en) | 2006-10-17 |
JP4940318B2 (ja) | 2012-05-30 |
EP2191790A2 (en) | 2010-06-02 |
US20060178694A1 (en) | 2006-08-10 |
US20060009799A1 (en) | 2006-01-12 |
US8758395B2 (en) | 2014-06-24 |
US20090275976A1 (en) | 2009-11-05 |
US20050049681A1 (en) | 2005-03-03 |
US7648532B2 (en) | 2010-01-19 |
WO2004103209A3 (en) | 2005-12-29 |
JP2007501093A (ja) | 2007-01-25 |
EP1648340B1 (en) | 2010-03-03 |
JP2010119888A (ja) | 2010-06-03 |
WO2004103209A9 (en) | 2005-01-13 |
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