CN1269707A - 预制导管导引的闭塞器械 - Google Patents
预制导管导引的闭塞器械 Download PDFInfo
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Abstract
一种可收紧的医疗器械10和相关的用于闭塞异常开口的方法,其中医疗器械10的形状由可热处理的金属编织品确定。金属编织品由若干金属线股构成并且在模具30中进行热处理以便基本上固定器械10的所需形状。医疗器械10包含固紧器22,用于附着到一导引金属线或输送导管上,其中医疗器械10的构成使得固紧器22附着到一形成在医疗器械10中的凹槽内部。
Description
本申请是1996年5月14日申请的申请号为第08/647,712号,题目为“预制导管导引的血管内用闭塞器械”的同在审理中的申请的部分继续,该申请又是1994年7月8日申请的申请号为第08/272,335号,题目为“医疗器械的形成方法;血管内用闭塞器械”的同在审理中的申请的部分继续。
发明背景
I.发明领域
本发明一般涉及用于治疗某些病症的血管内用器械,更确切地说,涉及用于治疗先天缺陷,如心房和心室隔膜缺陷(分别为ASD和VSD)以及动脉导管未闭(PDA)的小型血管内用闭塞器械。根据本发明制造的器械特别适用于通过一导管或类似物输送到远在病人心脏中的部位或者在病人体内的类似的脉管(Vessels)或器官。
II.相关技术的说明
在不同的医疗手术中使用各种各样的心脏内用器械。例如,通常使用某些血管内用器械,例如导管和导引金属线,只不过是为了输送液体或者其它医疗器械到在病人心脏内规定的位置,例如在血管系统中的选择的冠状动脉。在治疗特种病症时,例如在消除血管闭塞或用于治疗隔膜缺陷,通常使用其它更复杂的器械。
在某些情况下,可能需要闭塞病人的脉管,例如终止血液通过动脉流动到肿瘤或其它创伤部位(Iesion)。目前,普遍简单地通过例如加进Ivalon颗粒(一种血管闭塞颗粒的商标)和短截的螺旋弹簧到脉管中的所需位置。这些“栓塞介质”(“embolization agents”)最终将聚集堵塞(Iodged)在脉管中,经常浮动在该部位的下游,在该处在封闭脉管之前它们是松脱的。这种手术在利用该颗粒时经常受到限制,部分地是由于不能精确地定位该栓塞介质。这些栓塞介质通常不能用作心脏内用闭塞器械。
外科医生已使用与由Landymore等人在第4,836,204号美国专利中公开的相类似的囊(balloon)-导管,可暂时闭塞隔膜缺陷,使病人足以稳定直到打开心脏进行手术。当利用这种导管时,在导管的远端带有一可膨胀的囊。当将导管导向所需位置时,囊内充有液体,直到基本上充满脉管并聚集堵塞在其中。采用可固化在囊内侧的树脂例如丙烯腈(acrylonitrile),以便永久性地固定囊的尺寸和形状。然后可将囊由导管的端部脱开留在就地。如果囊没有足够充满,它将不能牢靠地聚集堵塞在隔膜缺陷处,并且可能旋转和从隔膜壁松脱,并到由右或左心室流出的血液中。过满的囊同样是不希望发生的,其可能导致囊的破裂并将树脂释放到病人的血液系统中。
对过去已提出的机械栓塞器械、过滤器、收集器(traps),它们的代表性的实例公开在King等人的第3,874,388号的美国专利(‘388专利)、Das的第5,334,217号的美国专利(‘217专利)、Sideris的第4,917,089号的美国专利(‘089专利)、Marks的第5,108,420号的美国专利(‘420专利)。‘388、‘217、‘089和‘420器械通常预装入到导引器(introducer)或输送导管,并且通常在医疗手术的过程中不由外科医生装入。在使用这种器械的过程中,如果不是不可能的话,也是难于再恢复(recapture)到该输送导管中,因此,限制了这些器械的有效性。
显然,这些器械的尺寸固有地受器械的结构和形状的限制。当利用例如为‘089、‘388、‘217和‘420的闭塞器械来闭塞隔膜缺陷时,器械的压力以及因此移位(dislodgment)的机会随缺陷的尺寸的增加而增加。因此,这些器械必须具有位于缺陷的每一侧的很大的固位裙边(retention skirt)。隔膜缺陷的位置经常决定了固位裙边的尺寸。在假膜(membranous)型隔膜缺陷中,如果不是不可能的话,在至少不局部闭塞主动脉的情况下,也是难于有效地将‘388、‘217、‘089和‘420器械定位。此外这些公开的器械往往相当贵并且制造耗时。因此,希望提供一种小型器械,其是可复原的和可收回的送入到输送系统中,不增加器械的总厚度,可以在假膜型隔膜缺陷中形成有相对小的可定位的固位裙边,且不用关闭主动脉。
此外,过去的器械的形状(例如方形、三角形、五角形、六角形和八角形)需要大的接触面积,具有的棱角延伸到心房的游离壁。每次心房收缩(每天接近100,000次)时,在器械内部的内装金属线被弯曲,形成结构疲劳折断,其占所有案例的近30%。此外,先前的器械需要French14-16导引用导管,故不可能利用这些器械治疗患有先天缺陷的儿童。
因此,最好提供一种可靠的栓塞器械,其易于通过6-7 French导管展开,又可精确地定位在脉管或器官内部。还希望提供一种小型的可复原的器械,用以在病人身体的器官中使用。
发明概述
本发明的主要目的是提供一种可靠的、小型的心脏内用闭塞器械,其可以治疗例如心室隔膜缺陷(VSD)、心房隔膜缺陷(下文称ASD)以及动脉导管未闭(下文称PDA)。当由弹性金属编织品形成这些血管内用器械时,提供若干弹性线股(strands),利用通过编织形成的金属线,以构成一种弹性材料。然后使这种编织品变形以便与一造型元件的模具表面形状总体一致,以及对与造型元件的表面相接触的该编织品在升高的温度下进行热处理。选择热处理的时间和温度,以便基本上将编织品固定在其变形状态。在热处理后,将编织品取下与造型元件脱离接触,基本上保留在其变形状态下的形状。这样处理的编织品限定了医疗器械的扩展状态,该器械可被使用通过一导管进入到病人体内的(液流)管(channel)。
本发明的实施例为医疗器械提供了特定的形状,该医疗器械可以根据本发明来制造以便满足医疗需要和手术。该器械具有一可扩展的小型的结构形状,可以包含凹式夹具(recessed clamps),其附着到一输送器械的一端或导引金属丝上,使得器械在就位之后能复原。在使用中,将一导引用导管就位并在病人体内移动,使导管的远端邻近所需治疗的部位,用以治疗生理病症。然后将本发明预选的具有预定形状的医疗器械收紧(collapsed)并插入到导管的内腔。将该器械推动通过导管并推出远端,据此,由于它的记忆特性,邻近治疗部位处往往基本上返回到它的扩展状态。导引金属丝或输送导管由夹具松开并取出。
根据第一实施例,一通常细长的医疗器械具有管状中间部分和一对扩展直径部分,每个扩展直径部分位于在中间部分的各一端。中间部位的长度接近于所要闭塞的器官的壁厚,例如隔膜(septum)的厚度尺寸。至少二扩展直径部分的其中之一的中心可以相对中间部分的中心偏移,由此能闭塞该假膜类型的心室隔膜缺陷,同时提供一具有足够尺寸的固位裙边,能可靠地封闭隔膜的异常开口。该器械的每一编织端都和一夹具结合在一起。该夹具凹入到该器械的扩展直径部分,因此,降低了器械的总长度尺寸,形成小型的闭塞物。
在另一实施例中,医疗器械通常为球形,具有一细长主体、带锥度的第一端和较大的第二端。第二端具有一编织盘,当盘在其中展开时,通常其方位垂直于(液流)管的轴线。将与编织端部连接在一起的夹具朝“钟”的中心凹入,形成一可降低高度尺寸的小型的器械。
附图简要说明
图1是本发明的医疗器械的透视图;
图2是图1所示的医疗器械的侧视图;
图3是图1所示的医疗器械的俯视图;
图4是适用于形成图1中所示的医疗器械的造型元件的局部剖开的侧视图;
图5是病人心脏的局部剖开的示意图,其中图1所示的医疗器械正使用在病人的血管系统中;
图6是适用于闭塞PDA医疗器械的放大的主视图;
图7是图6中的PDA医疗器械的局部剖开的侧视图;
图8是图6中的PDA医疗器械的俯视图;
图9是图6中的PDA医疗器械的仰视图;
图10是适用于闭塞ASD的医疗器械的放大的局部断面图,表示由输送导管的内腔被拉伸和局部伸出的状态;
图11是适用于闭塞PDA的医疗器械的放大的局部断面图,表示由输送导管的内腔被拉伸和局部伸出的状态;
图12是按预成形的外形表示图10中所示的ASD器械的放大的主视图;
图13是图12中所示的ASD器械的侧视图,表示稍微被拉伸和填有聚酯纤维的状态;
图14是图12中所示的ASD器械的侧视图,表示被拉伸和填有聚酯纤维的状态;
图15是按预成形的结构形状表示另一种ASD器械的放大的主视图;
图16是图15中所示的ASD器械的侧视图,表示被拉伸和填有聚酯纤维的状态;
图17是按预成形的结构形状表示另一种ASD器械的放大的主视图;
图18是图17中所示的ASD器械的局部断开的侧视图;
图19是图17中所示的ASD器械的局部断开的俯视图;
图20是图17中所示的ASD器械的局部断开的仰视图;
图21是图17中所示的ASD器械的局部断开的侧视图,表示位于病人心脏的ASD的状态;
图22是按预成形的外形表示适用于闭塞VSD的器械的放大的主视图;
图23是图22中所示的VSD器械的侧视图;
图24是图22中所示的VSD器械的局部断开的主视图;
图25是图22中所示的VSD器械的俯视图;
图26是图22中所示的VSD器械的仰视图;
图27是按预成形的结构形状表示的另一种VSD器械的放大的主视图;
图28是图27中所示的VSD器械的局部断开的侧视图;
图29是按预成形的结构形状表示的另一种VSD器械的放大的主视图;
图30是图29中所示的VSD器械的局部断开的侧视图;
图31是按预成形的外形表示的另一种VSD或PDA器械的放大的主视图;以及
图32是图31中的VSD或PDA器械的局部断开的侧视图。
优选实施例的详细说明
本发明提供一种预制(Percutaneous)导管导引的闭塞器械,用于闭塞病人体内的异常开口,例如心房隔膜缺陷(ASD)、心室隔膜缺陷(VSD)、动脉导管未闭(PDA)之类。在利用本发明的方法形成该医疗器械时提供平面或管形金属编织品。
该平面或管形编织品是由在各线股之间具有预定相互取向的若干金属线股形成的。管形编织品具有的金属线股形成两组基本平行的通常为螺旋形的线股,一组线股具“按手定则”(having a“hand”),即旋转方向与另一组线股相反。这种管状编织品在编织品业通常称作为编织物(管状编织物)。
金属线股的斜角(pitch)(即在各圈金属线和编织物的轴线之间限定的角度)以及编织品的纬密(pick)(即单位长度的圈数)及某些其它参数,例如在管状编织物中使用的金属线数量在确定该器械很多特性方面是重要的。例如,编织品的纬密和斜角越大,在编织品中的金属线股的密度就越大,该器械将越有刚性。金属线的密度越大,还能提供具有更大金属线表面面积的器械,通常这将增强(在血管中展开的)该器械闭塞的趋势。例如通过涂敷一种血栓溶解剂可以增强这种血栓形成作用;或者可消除这种血栓形成作用,例如通过涂敷一种光滑的、防形成血栓的化合物。当使用管状编织物来形成本发明的器械时,约50°的斜角和约74的纬密(每线性英寸)且大约直径为4毫米的管状编织物看来适用于编织该能够闭塞内径约2~4毫米的异常开口的器械。
金属平面编织品是一种更通用的编织品,可以构成单层纺织(woven)层、针织层之类。在纺织编织品中,通常有两组一般金属线股,一组线股是按一定角度取向的,例如通常垂直于另一组(具有约90°的斜角)。正如上面所指出的,可以选择编织品(或者在针织编织品的情况下,针织的纬密和图案,如平针或双面针织物)的纬密和斜角,以便优化最终形成的医疗器械的所需特性。
最好由所谓的形状记忆合金制造由金属线股构成的平面或管状编织品。这种合金往往具有一引起相变的温度,通过对该材料在某一临界转换温度之上加热引起材料的相变,可以使金属具有的优选形状固定。当该合金冷却下来时,合金将“记住”在热处理过程中曾有的形状并且将往往呈现这一形状,除非加以限制。
由如下的组合中可以不加任何限制地对适宜的金属线股材料进行选择,该组合组成:以钴为基料的低热膨胀合金(在本技术领域称为ELGELOY)、以镍为基料的高温高强度“超级合金”(由HaynesInternational按商标HASTELLOY销售)、以镍为基料的可热处理的合金(由International Nickel按商标INCOLOY销售)以及很多不同标号的不锈钢。在选择适用于金属线股的材料时,重要的因素是,当对金属线进行了预定的热处理时,该金属线会保留适当数量的由模具表面引起的变形(下文将介绍)。
在该优选实施例中,由一种形状记忆合金NiTi(称为镍钛诺)制造金属线股,其是一种镍和钛的接近理想配比的合金,并且还可以包含少量的其它金属以便得到所需的特性。NiTi合金成份的加工要求和变化在本技术领域中是公知的,因此,对这种合金这里无需详细讨论。这里引用Lind的第5,067,489号美国专利和Amplatz等的第4,991,602号美国专利可供参考,仅讨论形状记忆NiTi合金在导引金属丝中的应用。这种NiTi合金是优选的,因为它们是市售的,并且关于加工这种合金比其它已知的形状记忆合金了解得更多。NiTi合金还是弹性的,并且被称为“超弹性”或“假弹性”。这种弹性使得本发明的器械使用时能返回到预置的扩展形状。
当形成本发明的医疗器械时,将适合尺寸的一个平面或管状金属编织品插入到模具中,因此该编织品变形,通常与模具内腔的形状相一致。该内腔的形状是这样的,即使得金属编织品基本上变形为所需医疗器械的形状。平面或管状编织品中的金属线股的端部应是牢固的以防止金属编织品松散。正如下面所介绍的可以采用夹具或焊接固定金属线股的端部。
在管状编织物的情况下,可以将造型元件插入到模具中之前先就位在编织物的内腔内,以进一步限定该造型表面。如果管状金属编织品的端部已经利用夹具或焊接被固定,通过用手将编织品中的金属线股分开(moving apart),可以将造型元件插入管状编织品内腔。通过利用这样一种造型元件,可以充分精确地控制最终形成的医疗器械的尺寸和形状,并且保证编织品的形状与模具内腔相一致。
造型元件可以由经选择的材料构成,以便使造型元件能由金属编织品的内部破碎或取出。例如该造型元件可以由脆性或易碎的材料构成。一旦该材料与模具内腔和造型元件相接触且经过热处理,就可以将造型元件破碎为更小的块,使之可以易于由金属编织品的内部取出。如果这种材料是玻璃,造型元件和金属编织品可以对一硬的表面撞击以使玻璃破碎。然后可以将玻璃碎片由金属编织品的内部取出。
另外,造型元件可通过一种化学制剂而被一种可被化学地溶解或分解的材料形成,该化学制剂基本上不对金属线股的特性产生有害的影响。例如可以由利用适当的有机溶剂能够溶解的耐高温塑料树脂形成该造型元件。在这一实例中,可以对编织物和造型元件进行热处理,以使固定编织物的形状与模具内腔和造型元件的形状基本上一致,这时可以将造型元件和金属编织品浸入在溶剂中。一旦造型元件基本上溶解,可以将金属编织品由溶剂中取出。
应当小心选择以保证所选择的用以形成造型元件的材料能够经得住热处理,至少在编织品的形状已固定之前不会失去其形状。例如造型元件可以由一种熔点高于固定金属线股的形状所需的温度,但是低于形成线股的金属的熔点的材料构成。然后,可以对造型元件和金属编织品进行热处理以便固定金属编织品的形状,其时温度可以提高,以便基本上完全熔化造型元件,并由金属编织品内部取出造型元件。本技术领域的技术人员会认识到,模具内腔和造型元件的形状可以改变,以便制造出具有预选尺寸和形状的医疗器械。
应当理解,特定造型元件形成一特定形状,如果需要可以利用具有不同形状的其它造型元件。如果需要更复杂的形状,造型元件和模具可以包含有附加的部件,但是如果形成较简单的形状,模具可以具有较少部件。在一指定的模具中的部件的数量和这些部件的形状几乎完全由所需医疗器械的形状确定。
当管状编织物处于放松状态的形状时,形成管状编织物的金属线股将彼此相对具有第一预定的相关的取向。当管状编织物沿其轴线受到压迫时,该编织品往往由该轴线端部向外张开与模具的形状一致。当编织品这样变形时,金属编织品中的金属线股的相互取向将改变。当装配该模具时,金属编织品通常与内腔的模具表面相一致。医疗器械具有预固定的扩展外形以及收紧的外形,这就使得该器械能通过导管或者其它类似的输送器械。该扩展的外形通常是由当编织品变形时的形状确定的,与模具中的造型表面相一致。
一旦平面或管状编织品适当地定位在预选的模具内部,金属编织品通常与模具内腔的造型表面相一致,在维持与造型表面接触的同时可对编织品进行热处理。当编织品与造型表面相一致时,对金属编织品的热处理基本上按照一定取向的相对位置固定了金属线股的形状。当将金属编织品由模具中取出时,编织品保留模具内腔的造型表面的形状,因此,确定了具有所需形状的医疗器械。这种热处理大部分取决于金属编织品中的金属线股的构成材料,不过热处理的时间和温度应加以选择,以便基本上将编织品固定在其变形的状态,即在其中金属线股处在它们的相互取向的形状,编织品通常与造型表面相一致。
在热处理之后,将编织品取出与造型元件脱离接触,基本上使其形状保留在变形的状态。如果使用造型元件,如上所述可以取出造型元件。
热处理的时间和温度很大程度上取决于构成金属线股的材料。正如上面所指出的,一种优选类别的用于构成金属线股的材料是形状记忆合金,镍钛诺、镍钛合金是特别优选的。如果在制造编织品的金属线股时使用镍钛诺,当金属处在奥氏体相态时,金属线股将往往具有很强的弹性,这种很强的弹性的相态经常称之为超弹性或伪弹性相态。通过在某一相态转换温度之上加热镍钛诺,镍钛诺金属的结晶结构将往往“固定”编织品的形状和在热处理过程中它们所保持的位置上的金属线股的相关形状。
对镍钛诺金属线的适当热处理以便固定所需的形状,这在本技术领域中是公知的。在很多的医疗器械中使用按螺旋卷绕的镍钛诺线圈,例如在形成围绕一般导引金属线的远端连接部带有的线圈时。关于形成在这类器械中的镍钛诺有范围很宽的资料,使得这里无需对在本发明中优选使用的镍钛诺编织品热处理的参数进行更详细地介绍。简要地说,虽然已经发现,根据待制造的器械的软度或硬度,将镍钛诺编织品保持在约500~550℃持续大约1~30分,往往将编织品固定在其变形的状态,即它与模具内腔的造型表面相一致。在较低的温度下,热处理的时间将往往变长(例如在约350℃下约1小时),以及在较高的温度下,热处理的时间将往往变短(例如在约900℃下约30秒)。在对镍钛诺热处理之前,这些参数可按照在最终的制品中的镍钛诺所需特性和其它因素的需要而变化,以便适应镍钛诺的严格成份的变化,上述特性和因素对于本领域中的技术人员来说是公知的。
取代依靠常规的加热等方式,向镍钛诺提供电流以便将其加热,在本技术领域中是公知的。在本发明中,例如通过将电极连接到金属编织品的端部可以实现这一点。利用金属线的电阻加热则可以对金属线加热,以便实现所需的热处理,这往往会不需要加热整个模具到所需的热处理温度,只将金属编织品加热到所需的温度。这种材料、造型元件和模制该医疗器械的方法还进一步介绍在1996年5月14日申请的第08/647,712号的同在审查中的美国专利申请中(转让给本发明的同一受让人),这里引用它的全部公开可供参考。
一旦已经形成具有预选形状的器械,就可以将该器械用于治疗病人的生理病状。可以基本上按照下面概括介绍的其中一个实施例,选择一种适用于治疗该病状的医疗器械。一旦选中适当的医疗器械,可以将一导管或其它适当的输送器械就位在病人体内的一(液流)管内,使输送器械的远端接近需更治疗的部位,例如直接邻近病人器官内的异常开口(或者就在其中)。
该输送器械(未表示)可采用任何适宜的形状,不过最好包含一细长挠性远端带螺纹的金属柱身。输送器械可用于推动医疗器械通过导管的内腔,该医疗器械用于在病人体内的一(液流)管内展开。当该器械在导管远端以外展开时,由输送器械约束限制。一旦医疗器械适当地就位在异常开口的分路部位(shunt),输送器械的柱身可以围绕其轴线旋转,以便将医疗器械由输送器械旋下。
如果确定医疗器械未适当地就位在分路部位,通过使医疗器械保持附着在输送器械,手术人员可以收回该器械,用以相对于异常开口重新就位。一附着在医疗器械上的带螺纹的夹具使得手术人员可以控制医疗器械展开在导管远端之外的方式。当医疗器械穿出导管时,往往因弹性返回到一优选的扩展形状,该形状是当编织品热处理时固定的。当该器械弹性返回到这一形状时,其往往可以相对导管的远端动作有效地使本身朝导管端外侧推动。可以设想到如果该器械在(液流)管中的位置是临界例如就位在两个脉管之间的分路部位,这种回弹动作导致该器械不适当地就位。由于带螺纹的夹具能够使手术人员在展开的过程中握住该器械,由手术人员可以控制该器械的回弹动作,以保证展开的过程中正确地就位。
可以将医疗器械收紧并按其收紧的外形插入到导管的内腔。器械收紧的外形可以是任何适合易于通过导管内腔的形状,并适当地展开在导管的远端。例如一ASD闭塞器械可以具有相对细长的收紧外形,在其中该器械沿其轴线被拉伸(见图10)。通常通过沿其轴线拉伸该器械,例如用手握住夹具并将其拉开,其往往会使该器械中扩展直径的部分向内朝向器械的轴线收紧,可以实现这种收紧的外形。PDA闭塞器械也按非常相似的方式操作并通常可以通过沿器械的轴线施加拉力收紧,按其收紧的外形插入到导管的内腔,如图11所示。就此而言,这些器械不同于“中国式手铐(handcuffs)”,其在沿轴线拉力之下往往沿直径方向受限制。
假如该器械被用于永久性地闭塞在人体中的(液流)管,可以简单地收回导管并由病人的体内取出。这样就将展开的医疗器械留在病人的血管系统中,使得其可以闭塞血管或在病人体内的其它(液流)管。在某些情况下,医疗器械可按照这样一种方式附着到输送系统中,以便将该器械固定到输送器械的端部。在取出处于此系统中的导管之前,可能需要在取出导管和输送器械之前将医疗器械与输送器械拆开。
虽然该器械往往因弹性返回到其起始扩展的外形(即它为通过导管在被收紧之前的形状),应当理解不是总是能完全返回到该形状。例如可希望该器械在其扩展的外形下具有最大的外径,至少象要在其中展开的异常开口内腔的内径一样大,最好大于内腔的内径。假如这种器械在脉管或具有小的内腔的异常开口内展开,与内腔的贴合将防碍该器械完全返回到其扩展的外形。不过,因为贴合内腔的内壁安置在其中,该器械将适当地展开。
当该器械在病人体内展开时血栓(thrombi)将往往会聚集在金属线的表面上。通过形成更大的金属线密度,金属线的总表面面积将增加,可增加血栓活性并使该器械能相对快地闭塞(该器械在其中展开的)脉管。可以确信,由4毫米直径的管状编织物形成的纬密至少约为40、斜角至少约为30°的闭塞器械将形成充分的表面面积,在适当的一段时间内基本上完全闭塞2~约4毫米内径的异常开口或血管。若希望增加该器械的闭塞速度,可将各种公知的凝血剂涂敷在该器械上。
下面返回到附图,讨论将要提出的本发明的医疗器械的一些实施例。首先参照图1~图3,该图总体表示一适用于闭塞动脉导管未闭(PDA)的器械10。PDA基本上是这样一种病症,其中两个血管,最一般为主动脉和邻近心脏的肺动脉(pulmonary artery)具有在它们的内腔之间的分路。血液可以直接在这两个血管之间通过分路部位流动,损害了血液通过病人的血管中的正常流动。PDA器械10具有一通常为钟形的主体12和向外扩展的前端14。钟形的主体12适合于在脉管之间的分路部位的内部展开,而前端14适合于定位在主动脉内部,以有助于该器械的主体安置在分路部位中。主体12和前端14的尺寸可以按照对于不同尺寸的分路部位的需要变化。例如该主体12可以具有沿其通常为细长的中部的直径约10毫米和沿其轴线方向的长度约25毫米。在这种器械10中,该主体的底部通常可以沿径向向外张开,直到外径达到等于前端14的外径,其直径的量级可约为20毫米。
希望主体12的底部相当快地向外张开,以便限定一由主体12的中部向外快速渐缩的台肩16。当器械10在脉管中展开时,台肩16将按较高的压力贴住被治疗的内腔的周边。前端14约束在脉管内部并推动主体12底部张开,保证台肩16结合脉管的壁,以防止该器械在分路部位内部移位。
本发明的这一实施例的PDA闭塞器械10最好可以按上面概括介绍的方法制造,即,使管状金属编织品变形总体上与模具中的造型表面相一致,并对编织品进行热处理以便基本上将编织品固定在其变形的状态。正如上面指出的,管状编织物中的端部18和20应当是牢固的以便防止编织物松散。在该优选实施例中,使用夹具22以使在管状编织物的端部18和20处的金属线股的各个端部束缚在一起。应当理解,可以将其它适宜的固紧器械按其它方式例如通过焊接、软焊、铜焊、利用可适应生物的粘接材料或者按其它适合的方式附着到该端部。每个夹具22可以包含螺纹24,用以将该器械10连接到输送系统(未表示)。在所示实施例中,夹具22通常是圆柱形的,并具有卷边(crimping)的凹槽用于容纳各金属线股的端部以防止金属线彼此相对移动。
当使用未经处理的NiTi编织品时,各线股将往往返回到它们的未编织时的外形,并且该编织物可以相当快地松散,除非将编织物的端部的长度截短,以便使该器械彼此相对约束。使用该夹具22可防止编织物在其端部松散,因此,可有效地限定在沿长度密闭的编织品内部的空闲空间。这种夹具将被切断的编织物端部固定在一起,并防止编织物松散。虽然对NiTi合金的焊接和铜焊已证明是相当困难的,各端部可以焊接到一起,例如用激光焊接器进行点焊。当切断该编织品达到所需尺寸时,应小心操作以保证编织品不会松散。在例如利用NiTi合金形成管状编织物的情况下,除非加以限制,否则各个线股往往会返回其热固定的外形。如果对编织物进行热处理,以便将线股固定在经编织的外形,它们往往会保留编织物的形状,并且仅端部被磨损。然而,不对编织物进行热处理而简单地形成编织物,可能是更经济的,由于编织品将在形成医疗器械时再次进行热处理。
图4中表示的模具30通常分别包含上模板32和下模板34。在每个模板32和下模板34的内部形成有对应的内腔36和38,因此限定了上模板和下模板中的造型表面。上模板32中的内腔36适合于形成PDA器械10中的主体部分12,而下模板34中的内腔38适合于形成PDA器械10中的台肩16和前端14。上模板32通常包含细长的管状中心部分40,其尺寸适合于形成PDA器械10中的主体部分12。上模板32的内腔36中的一部分最好具有一内径稍小于该器械中的管状编织物的自然放松时的外径。压迫编织物有助于形成可重现其尺寸的主体12。模具30中的下模板34具有一通常圆盘形的内腔38,希望内腔38约在其中心的具有一卡口42,用于容纳该附着到管状金属编织品的一端上的夹具22。
在使用中,将金属编织品置于在上模板32中的内腔36中的圆柱形部分40。然后使上模板32和下模板34合在一起,这样的下模板34的内腔38贴住编织品并且在压力下往往将编织品沿径向向外推进。于是编织品总体上被封闭在模板的内腔36和38之内,并与内腔的表面相一致。如果要防止整个夹具22通过卡口42,编织品将与该表面中的内表面稍微分开,在该器械的前端形成稍微的穹形。虽然所示实施例包含这样的穹形的前端16,但应当理解,台肩16和前端14可以基本上是平的,通过使夹具22整体容纳在下模板中的卡口42中可以实现这一点。
一旦编织品受到压迫,就可以对编织品进行热处理,如在上面概括介绍的。当通过移动上模板32和下模板34使之彼此分开而再次打开模具30时,该编织品将保留其受压迫变形的外形。可以将形成的器械收紧,例如通常通过沿轴向推动夹具22使得彼此分开,且往往会朝器械的轴向收紧器械10。于是被收紧的器械附着到输送器械28并通过用于在病人体内的预选位置展开的导管26。
图5表示位于病人心脏中的PDA器械10,用于闭塞PDA。所示器械10处于分路部位的位置,而扩展在病人的主动脉“A”和肺动脉“P”之间。该器械通过PDA,例如通过使器械10收紧在导管内部,以及可以使器械10中的台肩16因弹性扩展基本复原到其热固定的形状,通过热处理过程“记忆的”形状,例如通过向远端推动该器械以便扩展到导管的远端之外。台肩16应当大于PDA的分路部位的内腔。
然后可以将该器械收回,使得台肩16与肺动脉“P”的壁贴合。如果持续地收回该导管,该器械与肺动脉“P”的壁的贴合将往往自然地将该器械中的主体部分12由导管拉出,这样就使主体部分12返回到其扩展状态下的外形。应确定主体部分12的尺寸,以便使其与PDA的内腔分路部位摩擦贴合。然后通过在主体部分12和内腔分路部位之间的摩擦与对该器械的台肩16的主动脉血液压力的结合,使该器械保持就位。在相对短的一段时间内,在该器械内或器械上将形成血栓,该血栓将闭塞PDA。本领域的技术人员将会认识到,为了加速本发明的器械的闭塞作用,可以将该器械涂敷凝血剂,填有聚酯纤维(见图12~图16)、填有尼龙片(见图17~图20)或者增加了金属线股的数量的编织物。
接着参阅图6~图9,该图表示另一个PDA器械50。该PDA器械50包含带锥度的圆柱主体部分52和由主体部分沿径向向外扩展的台肩54。该编织品的每一端部56和58朝主体部分52的内腔的中心凹陷。按照这种方式,夹具60附着到管状编织品的端部被隐藏在器械50内,因此,降低了PDA器械总长度并且进一步使该器械的外形变得更小。
图12~图14和图17~图20表示本发明的医疗器械100的另一个优选的实施例,该器械100用于校正心房隔膜缺陷(ASD)。参阅图12和图17~图20,处在放松的未拉伸状态的器械100具有两个对正的盘102和104,通过一短的中间圆柱形部分106连接在一起。这种器械100也可以很适于闭塞在本技术领域称之为卵圆孔未闭(PFO)的缺陷。本技术领域的技术人员将会认识到,这种结构的器械还可适用于在有孔缺陷方丹(Fenestrated Fontan)手术中的穿导管封闭。ASD是一种房隔先天性异常,其特征在于房隔的结构性缺陷。可以在房隔中设一分路,以便在左和右心房之间流通。在一些具有明显由左通过缺陷部位向右分流的大的缺陷中,右心房和右心室体积量(volume)过载以及增加的体积量排出进入低阻力的肺血管床。
肺血管闭塞性病症和肺动脉高血压在成年人中发展。对患有ASD明显分流(按照肺部血液流到全身系统的血流比大于1.5)的病人做手术,理想是在5岁或者在若干年之后进行诊断时进行手术。随着二维回波心动描记法和多普勒彩色血流测绘图(color flow mapping)的出现,可以观察到该缺陷的精确的构造。所选择的ASD器械100的尺寸对应于缺陷的尺寸。
在图12和图17~图20中表示处于非约束或放松状态的器械100,其适合于在该包含ASD或PFO的分路中展开(见图21)。为了示范的目的,下面将介绍在ASD封闭手术中使用器械100。首先转向器械100的结构特征,该ASD(闭塞)器械100的尺寸与要闭塞的分路的尺寸成比例。按放松状态时的取向,金属编织品的形状是这样的,即两个盘状元件102和104轴向上对正并且通过该短的圆柱形部分106连接在一起。圆柱形部分106的长度最好接近于房隔的厚度,其范围在2~20毫米之间。近侧盘102和远侧盘104的外径最好充分大于分路尺寸,以防止器械的移位。近侧盘102具有相对平的外形,而远侧盘104朝向该近端成杯形稍微重叠近侧盘102。按照这种方式,器械100的回弹动作将使远侧盘的周边边沿108完全贴合隔膜的侧壁以及按相似方式使近侧盘102的外沿完全贴合隔膜的侧壁。
可将管状编织的金属编织品器械100的端部焊接或者利用夹具112夹在一起,与上面介绍的相似,以避免破损。当然,该端部可以利用在本技术领域中的技术人员公知的其它方式另外保持在一起。夹具112将在一端的金属线股束缚在一起,其还将该器械连接到输送系统(见图10)。在所示实施例中,夹具112通常是圆柱形的,并具有凹槽以便容纳金属编织品的端部,基本上防止纺织的编织品包含的金属线彼此相对移动。夹具112在凹槽内部具有螺纹表面。这种带螺纹的表面适合于容纳和连接输送器械28带螺纹的远端。
本发明的这一实施例的ASD闭塞器械100最好根据上面概括的方法制造。该器械最好由0.005英寸的镍钛诺金属线网构成。金属线网的编织可以利用具有72线传导部件(carriers)的Maypole编织机按照每英寸28的纬密以及按照约64°的屏蔽(shield)角实施。ASD器械100的刚度通过改变金属线尺寸、屏蔽角、纬密的尺寸、金属线传导部件的数量或者热处理的过程可以增加或者降低。图12~图14表示填有公知的具有适宜结构的闭塞纤维的ASD器械100的内腔。图17~图20表示在器械内部填有公知的具有适宜结构的闭塞编织品114的ASD器械100。
本技术领域中的技术人员根据前面的讨论会认识到,模具的内腔必须与ASD器械的所需形状相一致。且某些所需的外形可能需要内腔的各部分仿形(cammed)。图15和图16表示另一种ASD器械120,具有一种改进的结构并稍微被拉伸。近侧盘122是远侧盘124的镜像,两者都呈杯状。每一端都利用夹具128固定。近侧盘122与远侧盘124的间隔距离最好等于或者稍小于圆柱形部分126的长度。近侧盘122与远侧盘124呈杯状保证了在它们的外沿和房隔之间的完全接触。通过适当就位,在闭塞器械的范围内形成内皮(endothelial)的新的心内膜层,因此降低了细菌心内膜炎的机会。
器械120中的近侧盘122与远侧盘124的间隔距离可以增加,以便提供一种适用于在闭塞病人体内的(液流)管时使用的闭塞器械,其作为脉管闭塞器械使用具有特殊的优点。图15和图16中所示的器械包含一般为管状的中间部分126和一对扩展直径的部分122和124。扩展直径的部分位于在一般为管状的中间部分的各一端。管状中间部分126和扩展直径的部分122和124的相对尺寸可以根据需要变化。在这一特定实施例中,该医疗器械意在用作脉管闭塞器械,以基本终止通过病人体内的脉管血液的流动。当器械120在病人体内的脉管内部展开时,其使其轴线与脉管的轴线一致位于在脉管内部。其哑铃的形状意在限制脉管闭塞器械相对于血管轴线转一角度的能力,以保证其维持在由手术人员将其展开在脉管内部的基本相同的位置。
为了相对强地贴合血管的内腔,应当选择该扩展直径的部分122和124的最大直径,使其至少与要在其中展开的脉管的内腔的直径一样大,最好比该直径稍大一些。当在病人的脉管中展开时,该脉管闭塞器械在两个隔开的部位将贴合该内腔。最好该器械沿其轴线的长度大于该最大直径的尺寸。这样将基本防止脉管闭塞器械120在该内腔内部相对其轴线转动,基本上防止该器械移位以及在通过脉管流动的血液内部沿脉管翻滚。
脉管闭塞器械120中的管状中间部分126和扩展直径的部分122和124的相对尺寸可以对特定的应用场合按需要变化。例如,中间部分126的外径范围可以在扩展直径的部分的最大直径的约1/4~1/3以及中间部分126的尺寸可以约为器械120的总体长度的20%~50%。虽然这些尺寸是适宜的,应当理解,如果该器械仅用于闭塞血管,如果该器械用于其它场合,例如要将该器械用于血管过滤器而不是用于基本上闭塞整个脉管,或者将器械120展开闭塞在器官壁中的异常开口,这些尺寸可以变化。
在这一实施例中所述的器械120的形状比(即器械的长度与它的最大直径或宽度的比)希望至少为约1.0,范围为约1.0~3.0是优选的,形状比为约2.0则是更为优选的。采用较大的形状比能防止器械120通常沿与其轴线垂直的方向旋转(这种旋转称之为翻滚)。只要器械120中的扩展直径的部分122和124的外径足够大,使该器械相对(要在其中展开的)(液流)管的内腔充分牢靠地安置,该器械就不能翻滚有助于该器械保持精确展开,在定位在其病人的脉管系统或者在病人体内的其它(液流)管内部的情况下。另外,扩展直径的部分122和124自然放松时的直径明显大于其中展开该器械的脉管的内腔,应当足以楔入该器械就位在脉管中,不会过分相关于该器械的形状比。
下面参阅图22~图26,所示的器械140优选用于闭塞假膜型心室隔膜缺陷(VSD)。该具有扩展的预设的外形器械140包含两个扩展直径的部分142和144以及一配置在两个扩展直径的部分142和144之间的降低直径的部分146。两个扩展直径的部分142和144各自具有凹槽148和150,其由扩展直径的部分142和144的外表面向内延伸。附着在管状金属编织品每个端部的夹具152包含在对应的凹槽148和150的内部(见图24)。降低直径的部分146的长度尺寸接近于在隔膜的异常开口的厚度。器械140具有扩展的预设的外形是可变形的,形成较小的断面尺寸用以输送通过在病人体内的(液流)管。扩展直径的部分的内表面可以是凹形或杯形的(与在图15~图16中所示的相似),以保证每个扩展直径的部分的外周边接触隔膜壁。此外,扩展直径的部分142和144的至少其中之一相对于降低直径的部分146是偏移的。扩展直径的部分142和144的其中之一的中心不与降低直径的部分146的中心对正。按照这种方式,当该异常开口处在主动脉附近时,该偏移固位裙边或扩展直径的部分142和144在就位时将不会封闭主动脉。
图27和图28表示另一种优选的VSD器械160,其中两个扩展直径的部分162和164的中心和降低直径的部分166的中心是对正的。夹具168附着在金属编织品的端部并向内凹陷,以便提供一小外形的闭塞器械。夹具168可以具有内螺纹或外螺纹,用于附着到一输送器械或导引金属线。这种形状的器械160最好用在闭塞肌肉型的心室隔膜缺陷VSD。VSD器械的输送与上面介绍的相似。
图29和图30表示适用于闭塞肌肉型VSD的另一实施例。图29和图30所示的器械与在图27和图28所示的VSD器械相似,不过包含一些改进,其中降低直径的部分166的长度降低,两个扩展直径的部分162和164已受压因此降低了每个扩展直径的部分的厚度尺寸。图31和图32表示与图29和图30所示的器械相似的另一实施例。图31和图32所示的器械适用于闭塞PDA,其中病人患有肺部高血压(pulmonary hyper tension)。两个扩展直径的部分162和164经模压具有细的断面,因此避免影响流体通过肺部静脉或主动脉的流动。此外,降低直径的部分166是带锥度的,以便增加与围绕该缺陷的组织相接触的表面面积。
再次参照图21,下面更详细地讨论将本发明的器械用于闭塞隔膜缺陷的情况。例如利用二维回波心动描记法和多普勒彩色血流测绘图可以输送该器械120和使之适当就位。正如前面所指出的,输送器械28可以取任何适宜的形状,最好包含与常规的相似的细长的挠性金属柱身。输送器械28用于推进ASD闭塞器械120通过小直径的圆柱形管26的内腔,例如一输送导管用以展开。通过拉伸该器械120使之成细长形,将ASD闭塞器械120装入小直径的圆柱形管26。该器械可以在手术过程中或者在制造设备中预组装时插入到管26的内腔中,当维持在受压的状态时,本发明的器械不永久性的安置。
根据股骨(femoral)静脉入口方案,该输送导管或管26横穿通过ASD。器械通过该输送导管行进直到在导管的输出端,其远端不受限制,在左心房中其为盘状。然后将输送导管26沿接近方向拉回经过ASD以及输送器械28以同样方式沿接近方向拉回,相对隔膜170推进该远侧盘。然后将输送导管26进一步由隔膜170拉开,以使近侧盘由输送导管26中脱出扩展,在这种情况下,其因弹性返回其预定的扩展的盘形状。按照这种方式,将ASD闭塞器械120定位,使远侧盘压迫隔膜170的一侧,而近侧盘压迫隔膜170的另一侧。为了提高其闭塞能力,该器械可以包含聚酯纤维(见图13和图14)或者尼龙纤维(见图17~图20)。在第一次尝试不适当地展开该器械的情况下,通过将输送器械28拉近,器械120可以复原,以此使器械120退回到输送导管26中在第二次尝试之前,在将器械120相对该缺陷定位时。
当ASD闭塞器械120适当就位时,外科医生旋转输送器械28,由闭塞器械120中的夹具128旋下输送器械28。在夹具128上的螺纹是这样的,即旋转输送器械28由闭塞器械120中的夹具128旋下输送器械,而不是仅旋转闭塞器械120。正如在另一实施例中所指出的,带螺纹的夹具128使手术人员能够在展开的过程中掌握该器械,或者使手术人员能够在该器械展开的过程中控制该回弹动作,以保证适当的就位。
这里已相当详细地介绍了本发明提供给本技术领域的技术人员关于应用新颖的原理和构成作为按照需要的各实施例所需的信息。然而,应当理解,可以利用各种不同的器械实施本发明,在不脱离本发明的范围的情况下可以实现各种改进。
Claims (18)
1.一种可收紧的医疗器械,包含一金属编织品,其具有预设扩展的外形,在该预设扩展的外形的每个近端和远端包含一凹槽,所述每个近端和远端具有一装置,其用于将附着到金属编织品上的每一端部固定和容纳在凹槽内部,其中所述医疗器械的形状能闭塞异常开口,因此所述预设扩展的外形可变形为较小断面形状,用以输送通过病人体内的液流管,该金属编织品具有记忆特性,使得当不加约束时医疗器械往往返回到所述预设扩展的外形。
2.如权利要求1所述的医疗器械,其中预设扩展的外形包含两个扩展直径的部分和一个位于在两个扩展直径的部分之间的降低直径的部分,所述降低直径的部分的长度尺寸接近于异常开口的厚度。
3.如权利要求2所述的医疗器械,其中至少一个扩展直径的部分的内表面是凹形的。
4.如权利要求2所述的医疗器械,其中第一扩展直径的部分的内表面是凹形的,降低直径的部分的长度尺寸使得第一扩展直径的部分的周边边沿与第二扩展直径的部分的周边边沿重叠。
5.如权利要求2所述的医疗器械,其中至少一个扩展直径的部分的中心相对降低直径的部分的中心是偏移的。
6.如权利要求1所述的医疗器械,其中降低直径的部分的长度接近病人心房隔膜的厚度。
7.如权利要求1所述的医疗器械,其中降低直径的部分的长度接近病人心室隔膜的厚度。
8.如权利要求1所述的医疗器械,其中所述预设扩展的外形是钟形的。
9.如权利要求1所述的医疗器械,其中所述预设扩展的外形是哑铃形的。
10.一种可收紧的医疗器械,包含一金属编织品,其具有预设扩展的钟形外形,在每个近端和远端包含一凹槽,所述的每个近端和远端具有一装置,其用于将附着到金属编织品上的每一端部固定和容纳在凹槽内部,其中所述医疗器械的形状能闭塞一种动脉导管未闭部分,因此所述预设扩展的外形可变形为较小断面形状,用以输送通过病人体内的液流管,该金属编织品具有记忆特性,使得当不加约束时医疗器械往往返回到所述预设扩展的外形。
11.一种可收紧的医疗器械,包含一金属编织品,其具有预设扩展的外形以及包含两个扩展直径的部分和一个位于在两个扩展直径的部分之间的降低直径的部分,每个扩展直径的部分具有一由扩展直径的部分的外表面向内延伸的凹槽,使得一用于将金属编织品上的外沿固定的装置附着到和容纳在凹槽内部,所述医疗器械的形状能闭塞异常开口,所述降低直径的部分的长度尺寸接近于异常开口的厚度,因此所述预设扩展的外形可变形为较小的断面形状,用以输送通过病人体内的液流管,该金属编织品具有记忆特性,使得当不加约束时医疗器械往往返回到所述预设扩展的外形。
12.如权利要求11所述的医疗器械,其中降低直径的部分的长度接近病人心房隔膜的厚度。
13.如权利要求11所述的医疗器械,其中降低直径的部分的长度接近病人心室隔膜的厚度。
14.如权利要求11所述的医疗器械,其中至少一个扩展直径的部分的内表面是凹形的。
15.如权利要求11所述的医疗器械,其中第一扩展直径的部分的内表面是凹形的,降低直径的部分的长度尺寸使得第一扩展直径的部分的周边边沿与第二扩展直径的部分的周边边沿重叠。
16.如权利要求11所述的医疗器械,其中至少一个扩展直径的部分的中心相对于降低直径的部分的中心是偏移的。
17.如权利要求11所述的医疗器械,其中所述用于固定的装置包含用于附着到输送装置上的内螺纹。
18.一种可收紧的医疗器械,包含一金属编织品,其具有预设扩展的外形以及在处于预设扩展的外形时的近端和远端,所述的每个近端和远端具有一装置,其用于将附着到金属编织品上的每一端部固定,其中预设扩展的外形包含两个扩展直径的部分和一个位于在两个扩展直径的部分之间的降低直径的部分,所述降低直径的部分具有在两个扩展直径的部分之间延伸的渐缩的断面,因此所述预设扩展的外形可变形为较小断面形状,用以输送通过病人体内的液流管,该金属编织品具有记忆特性,使得当不加约束时医疗器械往往返回到所述预设扩展的外形。
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US08/925,935 | 1997-09-08 | ||
US08/925,935 US5846261A (en) | 1994-07-08 | 1997-09-08 | Percutaneous catheter directed occlusion devices |
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---|---|
CA2302164A1 (en) | 1999-03-18 |
EP1862122A1 (en) | 2007-12-05 |
KR100393441B1 (ko) | 2003-08-06 |
CA2302164C (en) | 2004-03-02 |
EA200000206A1 (ru) | 2000-08-28 |
WO1999012478A1 (en) | 1999-03-18 |
AU727012B2 (en) | 2000-11-30 |
EP1011469A1 (en) | 2000-06-28 |
EP1011469A4 (en) | 2001-05-09 |
CN1091584C (zh) | 2002-10-02 |
US5846261A (en) | 1998-12-08 |
AU9374098A (en) | 1999-03-29 |
KR20010013991A (ko) | 2001-02-26 |
EP1011469B1 (en) | 2017-11-08 |
EA001447B1 (ru) | 2001-04-23 |
EP1862122B1 (en) | 2019-05-01 |
JP2001515748A (ja) | 2001-09-25 |
DE29825257U1 (de) | 2007-05-24 |
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