CN1102373C - 通过经皮导管定向的收缩阻塞装置 - Google Patents
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Abstract
一种用于阻塞身体器官中不正常的开口的可萎陷的医疗装置(10),其由一种形状记忆金属纤维定形。装置最好由一种连续的管状金属纤维制成并包括两个外阻塞部分(12),(14)和一个弹性中央、弹簧状互连结元件(16)。装置(10)包括一个用于连结到导线端部或输送导管的紧固件(30),(32)。
Description
发明领域
本发明涉及一种治疗某些心脏缺陷的装置和非手术的方法。尤其涉及一种用于对患有卵圆孔未闭(PFO)和大脑栓塞的患者实施非手术治疗的低位外形阻塞装置。根据本发明制造的装置能够自动调节具有偏心开口的瓣膜缺陷并尤其适合经导管等向患者心脏中的或患者体内的类似血管或器官中的远处位置的输送。
背景技术
有多种心内装置用于各种医疗过程中。某些血管内的装置如导管和导线可以用于把液体或其它医疗装置输送到患者心脏内的特定位置。例如导管可用于到达选择的血管系统内的冠状动脉,或/和导线可以用于把装置输送到患者心脏的内腔中。可以输送并用于治疗特殊的异常状态的复杂装置,如用于除去血管阻塞的装置或用于治疗瓣膜缺陷等的装置。
相似于在Landymore等的美国专利第4,836,204号和Linden等的美国专利第5,634,936号中描述的气囊式导管和可收缩的聚合物装置分别用于阻塞瓣膜缺陷。当利用相似于美国专利第4,836,204号中公开的气囊式导管时,可膨胀的气囊载于导管的远端。当导管被导向预定的位置时,液体填充气囊直到它充满血管并阻塞。将固化在气囊中的树脂如丙烯腈可以用于永久地固定气囊的大小和形状。然后可以从导管的一端卸下气囊并适当保留。美国专利第5,634,936号中描述的装置可以通过调节装置的pH值和亲水性的三元系统进行扩展和硬化(见第5,634,936号专利的第6栏,第40-45行)。如果这些装置不能完全地扩展,则它们将不能稳固地堵在瓣膜缺陷处,并可能会转动和从瓣膜壁松脱,从而释放到血流中。给第4,836,204号专利的装置加注过满同样会出现不希望的现象,它会导致气囊的破裂和树脂向患者血流中的释放。
过去已经提出了用于阻塞患者血管系统中缺陷的机械性栓塞装置。这些装置一般包括一对隔开的均具有可内部收缩框架(类似于雨伞的框架和外层)的补片,其中相对的补片和框架通过连结元件内连结。补片一般被对准并连结到连结元件的公共轴。连结元件可以是刚性或半刚性衬套,它可以使补片在横向及前后最小限度移动,从而将补片稳固地保持在靠近缺陷的瓣膜壁上。当阻塞的瓣膜缺陷有偏心开口时,贴附在衬套公共轴的补片会出现问题。因为补片贴附到公共刚性轴,所以至少其中有一个偏心开口不能被各自的补片完全覆盖。刚性或半刚性的衬套妨碍调节补片去补偿偏心开口。
这种机械装置的代表性的实例公开在King等人的美国专利第3,874,388号(‘388专利),Das的美国专利第5,334,217号(‘217专利),欧洲申请第0541,063A2号(‘063申请),Sideris的美国专利第4,917,089号(‘089专利)和Marks的美国专利第5,108,420号(‘420专利)。这些装置一般在移植过程之前被预先装入导引器或输送导管,并且在治疗过程中通常不由医生输入。在使用这种装置期间,如果可能,重新收复到输送导管中也是很困难的,因而限制了这些装置的效果。
在这些装置移植之前,必须判断接近缺陷的瓣膜壁厚度和缺陷的大致宽度,以便能够提供大小合适的装置。在初步荧光检查之前医生可以利用气囊导管和具有已知长度的不透射线的校准过的导线估算缺陷的大小、接近缺陷的瓣膜壁的形状和厚度。这样做虽然有用,但不能确定缺陷的精确大小和形状,因而增加了阻塞装置周围泄漏的可能性。因此,理想的装置是能够固有地调节缺陷的厚度和形状的装置。
明显地,现有装置的大小固有地受装置的结构和形状的影响。另外,当采用如‘089、‘388、‘217或‘420等专利中公开的阻塞装置阻塞瓣膜缺陷时,随着缺陷大小的增加,装置的压力及因而装置的移动机会均增加。因此,现有装置需要在缺陷每侧的位置上有过大的固位裙边。通常,瓣膜缺陷的位置表示固位裙边的大小。在膜片型瓣膜缺陷中,如果可能,有效定位‘388、‘217、‘089或‘420等中的装置而不局部地封闭主动脉也是很困难的。另外,所述的这些装置价格偏于昂贵并且制造耗时。
另外,现有装置的形状(如正方形、三角形、五角形、六角形和八角形)需要很大的接触面积并有延伸到心房自由壁的角。心房每次收缩(每天大约100,000次),延伸至心房壁的角弯曲,产生结构上大约30%的疲劳断裂。另外,现有的装置需要一种4.67~5.33mm的导管,不可能用这种装置治疗患有先天性缺陷的儿童。因此,提供一种可靠的栓塞装置是非常有益的,这种装置易于使用2~2.3mm导管,并自动调节缺陷的形状和厚度。本发明考虑到了现有技术中的种种不足。
发明概述
因此,本发明的主要目的在于提供一种可靠的、低位外形(low-profile)的心脏内阻塞装置,能够在具有偏心开口的瓣膜缺陷内自动地调节校准,其中该装置适于治疗包括卵圆孔未闭(PFO)的瓣膜缺陷。PFO实质上是一种存在于心脏两心房之间瓣膜中的异常的、较宽的开口。血液可直接在这两心房之间流动,兼顾血液的正常流动和患者心脏的效率。异常的开口或瓣膜缺陷不能垂直延伸瓣膜壁。相反,左心房瓣膜壁中开口的中心可以与右心房瓣膜壁中开口的中心偏离,因而需要偏离放置的“补片”有效地阻塞缺陷。另外,瓣膜壁可以非常薄,在两个阻塞补片之间分隔最小的距离。本发明的装置最好由一种连续的管状金属纤维形成,并包括两个相对隔开的“盘”、补片、或由挠性或弹性中心元件互连结的固位裙边。中心元件在两横向及前后方向屈曲,同时对每个盘提供向内的弹力。
当用弹性金属纤维形成这些血管内的装置时,给多根弹性绞合线配置通过编织弹性绞合线而形成的金属纤维以产生弹性材料。然后,这些绞合纤维变形,一般与模制元件的模制表面一致,并在升高的温度下与模制元件的表面接触地对绞合纤维进行热处理。热处理的时间和温度基本上选择为将绞合纤维置为变形态。热处理之后,纤维离开与模制元件的接触并基本上将其保持在变形状态。如此处理的绞合纤维确定医疗装置的松弛态,可以延伸或扩展该装置,并将导管穿入患者体内的通道中。本领域的技术人员会理解模具的腔体必须反映所需的装置形状,在1996年5月14日提交的已转让给作为本发明的同一受让人,名称为通过经皮导管定向的血管内阻塞装置的共同待定申请08/647/712中描述了另外的模制元件,该申请的整个内容在此引为参考。
本发明的装置具有特别适于阻塞PFO的特定装置。该装置具有松弛的低位外形结构并包括使得装置连结到输送装置或导线一端的夹具(能使装置在移位之后恢复)。在使用中,导管提前放置于患者体内,使得导管的远端邻近待治疗部位以处理生理状态。然后拉紧本发明具有预定形状的医疗装置并插入导管的管腔内。该装置被推进导管并从远端出来,因此,由于形状记忆特性,它将基本上回到邻近治疗位置的松弛态。然后从夹具中释放导线或输送导管并移开。
发明目的
本发明的一个主要目的在于提供一种适于阻塞瓣膜缺陷的装置,能够自动地调节瓣膜缺陷的偏心开口、同时在装置的阻塞部位上提供向内的弹力。
本发明的另一个目的在于提供一种适于阻塞具有偏心开口的瓣膜缺陷的装置,其中该装置特别适于经导管等向患者心脏中的远处位置或相似血管或器官输运。
本发明的另一个目的在于提供具有外阻塞部位和挠性弹性中心部位的阻塞装置,能够把外阻塞部位阻塞到一起。
附图详细说明
图1是根据本发明的卵圆孔未闭阻塞装置透视图;
图2是图1所示类型的医疗装置侧视图;
图3是图2所示类型的医疗装置局部侧视图,表示沿其纵向轴的局部延伸;
图4是图3所示类型的医疗装置侧视图,表示沿其纵向轴的稍长于图3的局部延伸;
图5是图4所示类型的医疗装置侧视图,表示沿其纵向轴的稍长于图4的局部延伸;
图6是图1所示类型的医疗装置局部延伸的侧视图,其中相隔盘的外周边偏移;
图7是图1所示类型的医疗装置局部侧视图,表示沿其纵向轴的局部延伸;
图8是本发明另一实施例的侧视图,表示沿其纵向轴的局部延伸;
图9是本发明另一实施例的侧视图,表示沿其纵向轴的局部延伸;
图10是本发明另一实施例的侧视图,表示沿其纵向轴的局部延伸;
图11是图8实施例的局部侧视图,表示阻塞瓣膜壁的PFO;
图12是图8实施例的局部侧视图,表示阻塞瓣膜壁的PFO;和
图13是图1实施例的局部侧视图,表示阻塞瓣膜缺陷。
本发明提供经皮导管导向的阻塞装置,用于阻塞患者体内的非正常开口,尤其适于阻塞PFO(见图11-13)。阻塞装置包括两个由挠性弹性中心部分互连结的相隔的阻塞元件。夹具连结到每个阻塞元件的外端部,其中夹具适于耦接到导线或导管的端部向患者体内的预定位置输送。在优选实施例中,阻塞装置由单个连续管状金属纤维构成。
管状纤维由多根在绞合线中有预定相对取向的股线形成。本领域的技术人员将会理解编织线的投梭和间距可依据纤维的期望密度改变。管状纤维有确定两组基本上平行的螺旋和重叠式绞合线的金属绞合线,其中一组绞合线具有一种“方位”,即旋转方向,与另一组相对。此管状纤维在纤维行业被认做一种管状编织。
绞合线的间距(即绞合线的指向和编织轴之间的夹角)和纤维的投梭以及其它因素,如管状编织中使用的股线数量、编织中每股股线的大小或直径和编织的直径等在决定装置的多个重要特性方面都很重要。例如,纤维的投梭和间距越大,纤维中绞合线的密度越大,装置就越坚固。另外,绞合线的每股直径越大,装置就越坚固。较大的股线密度将提供给装置较大的股线表面积,这将总的增强装置阻塞应用区域面积趋势。这种血栓形成性即可以通过涂敷血栓溶解剂提高,也可以通过涂敷润滑的、抗血栓形成混合物减弱。当利用管状编织形成本发明的装置时,适于用大约有72股编织线的4mm直径的管状编织制作能够阻塞非正常开口和/或瓣膜缺陷的装置。
管状金属纤维的绞合线最好由所谓的形状记忆合金制成。这种合金易于具有引发相位改变的温度,将会导致材料具有优选的结构,该结构可通过把材料加热到特定的临界温度以引发材料相位改变来固定。当合金被冷却时,将“记忆”其在热处理时所具有的形状并趋于保证该结构,除非限制这样做。
如果没有任何有意的限制,可以从ELGELOY领域被称作包括钴基的低热膨胀合金、镍基高温高强度“超合金”(镍钛金属互化物)、International Nickel出售的商标名为INCOLOY的镍基可热处理合金和多种不同等级的不锈钢中选择适当的绞合线材料,其中镍基高温高强度“超合金”可从市场上得到商标为HASTELLOY的Haynes International的产品。选择适合的绞合线材料的重要因素在于股线保持适当量的变形,该变形产生于经受预定热处理时模制表面(如下所述)。
在优选实施例中,绞合线由形状记忆合金NiTi制成,并且还可包括其它微量的金属以实现理想的特性,其中NiTi(镍钛金属互化物)是镍钛的大约理想配比的合金。NiTi合金成份的加工要求和变化是公知技术,因此这种合金不需要在此详细讨论。美国专利第5,067,489号(Lind)和第4,991,602号(Amplatz等人)讨论了导线中形状记忆合金NiTi的使用,其内容在此引为参考。此NiTi合金至少部分需要,因为它们可从市场上获得并关于其加工比其它的形状记忆合金更为熟悉。NiTi合金也非常具有弹性并且是“超弹性”或“伪弹性”。此弹性能使得本发明的装置在应用后返回到预置的结构。
当形成根据本发明的医疗装置时,把大小适当的管状金属纤维件插入到模具中,纤维由此变形成总体上与模具中的腔体形状一致。腔体的形状使得金属纤维实际上变形成所需的医疗装置的形状。腔体内的芯还用于形成腔体内的纤维形状。应固定管状金属纤维的绞合线端部以防止金属纤维解开。可以采用如下所述的夹角或焊接来固定绞合线的端部。
在模制过程中,模制元件可以在插入到模具中之前放置在管状编织的腔内,以便进一步确定模制表面。如果管状金属的端部已经通过夹角或焊接固定,则可以通过手工移开纤维的绞合线并把模制元件插入到管状纤维腔内而把模制元件插入腔内。通过利用这种模制元件,可以稳定准确地控制医疗装置成品的形状并确保纤维与模具腔一致。
模制元件可以由选择的材料形成,使得模制元件能够被打破并从金属纤维中移去。例如,模制元件可以由易碎或易脆的材料形成。一旦该材料接触模具腔和模制元件进行热处理,模制元件即可破碎成很容易从金属纤维中除去的小片。例如此材料是玻璃,则模制元件和金属纤维可以与硬表面相撞,使玻璃散落。然后可以从金属纤维的外罩中除去玻璃碎片。
另外,也可以由能够被化学试剂溶解或通过破坏的材料形成,但这些化学试剂实际上不影响金属绞合线的特性。例如,模制元件可以由能溶于适当的有机溶剂的耐温塑料树脂形成。在此例中,金属纤维和模制元件可以经过热处理以制成与模具腔和模制元件一致的纤维形状,因此,模制元件和金属纤维可以伸出溶剂。一旦模制元件溶解,就可以从溶剂中除去金属纤维。
应该特别小心地确保选取的用于形成模制元件的材料能够经受热处理而不丧失其形状,至少直到设置了纤维的形状时材料能够如此。例如,模制元件可以由熔点在设置绞合线形状所必须的温度以上、但低于形成绞合线的金属熔点的材料形成。然后可以对模制元件和金属纤维热处理以设置金属纤维的形状,因此可以把温度升高到实质上完全熔化模制元件,从而从金属纤维中除去模制元件。
本领域的技术人员可以理解模制元件的特定形状产生被模制装置的特定形状。如果希望更复杂的形状,则模制元件和模具可有附加的部分,包括一个凸轮系统配置,但如果要形成一种较简单的形状,则模具可以有不多的部件。给定模具的部件数和那些部件的形状几乎将通过所需医疗装置的形状完全地确定,金属纤维将与医疗装置的所需形状一致。
例如,当管状编织处于其预制的松弛结构时,形成管状编织的绞合线将有相对于另一个的第一预定取向。当沿管状编织的轴向将其压缩时,纤维将被拉直离开与模具的形状一致的轴。当纤维如此变形时,金属纤维绞合线的相对取向将改变。当组装模具时,金属纤维总的将与内腔的模制表面一致。经历形状记忆过程之后,所成的医疗装置具有一种预置的松弛结构和萎陷的或拉长的结构,使得该装置能够通过导管或其它类似的输送装置。当发生形变以与模具的模制表面一致时,松弛的结构通常由纤维的形状确定。
一旦管状或平面金属纤维恰当地位于预选的模具中并且金属纤维总的与模具内腔体的模制表面一致时,纤维可以经受热处理,同时保持与模制表面接触。对镍钛金属互化物的线进行热处理以设置预定的形状是公知的现有技术。例如,在大量的医疗装置中采用螺旋式缠绕镍钛金属线圈,如形成通常导线远端环绕的线圈。在这种装置中形成镍钛金属互化物已有广泛的认识,因此在此不需要对用于本发明的优选镍钛金属纤维热处理的参数做详细的描述。简言之,已经发现根据要制成的装置的软度和硬度把镍钛金属纤维保持在摄氏500度至摄氏550度的温度下约1~30分钟而把纤维置于变形态,即其中与模具腔的模制表面一致。在低温下,热处理时间将变得较长(如在350℃下大约为1小时),在高温下热处理时间将变得较短(如在900℃大约为30秒钟)。这些参数可以按需要改变,从而适应镍钛金属互化物的精确成份、镍钛金属互化物的在先热处理、成品中镍钛金属互化物的期望特性和本领域技术人员公知的其它因素等方面的变化。
不依靠热传递,现有技术中还获知将电流应用于对镍钛金属互化物的加热。例如在本发明中,可以通过将电极连结到金属纤维的每一端来实现。然后,为了实现期望的热处理,可以通过导线的电阻加热而对导线加热,这将消除对加热整个模具到期望的热处理温度的需要,以便把金属纤维加热到期望的温度。于1996年5月14日提交的属于本发明同一申请人的待定美国专利申请08/647,712进一步阐述了由管状或平面金属纤维制造医疗装置的材料、模制元件及模制的方法,其内容在此引为参考。
在500~550℃的温度范围内热处理金属纤维实际上在重新取向的相对位置设置绞合线的形状,使纤维的形状与模制表面一致。当从模具中移去金属纤维时,该纤维保持模具腔的模制表面的形状,从而使医疗装置确定成一种理想的形状。热处理之后,移开与模制腔接触的纤维,实质上将其形状保持在变形状态。如果采用模制元件,可以如上所述地除去模制元件。
热处理过程所需的时间将依据形成金属纤维绞合线和模具总体的材料,但热处理的时间和温度应选成实际上将纤维置于变形态,即绞合线处于重新取向的相对形状并且纤维一般与模制表面一致。热处理所需的时间和温度可以很大程度地依据形成绞合线所采用的材料而改变。如上所述,形成绞合线的一类优选材料是形状记忆合金,尤其是镍钛金属互化物、镍钛合金。如果镍钛金属互化物用于制作纤维的绞合线,则当金属处于奥氏体相时绞合线将会变得弹性非常强;这种弹性非常强的相态通常被称作超弹性相或伪弹性相。通过把镍钛金属互化物加热到特定的相变温度以上,镍钛金属的晶体结构将趋于在热处理期间保持的位置处设置纤维的形状和绞合线的相对形状。
一旦形成具有预定形状的装置,该装置即可用于治疗患者的生理状况。选择一种适于治疗患者状况的医疗装置。当选定了合适的医疗装置后,把导管或其它合适的输送装置定位到患者体内的通道中,从而把输送装置的远端放置到邻近的期望治疗的部位,如患者器官中不正常开口的旁路近旁(甚至其内)。
输送装置(未示出)可以采取任何适当的形状,但最好包括一个具有螺栓远端的伸长的挠性金属轴。输送装置可用于推动医疗装置穿过在患者体内通道中应用的导管腔。当装置用于张开导管的远端时,装置将仍通过输送装置保持。一旦医疗装置恰当地定位于不正常开口的旁路中时,可以把导管的远端压向医疗装置,并且金属轴或导线可以绕其轴转动,以便从轴的螺栓远端旋出医疗装置。然后抽出导管和导线。
如果确定了装置没有正确地定位到旁路中,则通过保持医疗装置连结到输送装置,操作者可以抽出装置,重新相对于不正常开口定位。连结到医疗装置的螺栓夹角使得操作者可以控制医疗装置张开导管远端的方式。当装置从导管中出来时,趋向于弹性恢复到优选的松弛形状。当装置弹性回复到此种形状时,趋向于反作用到导管的远端,将其本身有效地向前推向导管的端部以外。如果装置在通道中的位置处于临界位置,如位于两脉管之间的旁路,则此弹性作用可想象地导致装置不正确地定位。因为螺栓夹角能使操作者在应用期间保持拉住装置,所以操作者可以控制装置的弹性作用以确保应用期间的正确定位。
医疗装置可被萎陷成凹瘪的形状并插入到导管的腔内。装置的凹瘪形状可以是任何一种适于容易地穿过导管腔并正确地张开导管的远端的形状。例如,PFO阻塞装置可有较长的凹瘪形状,其中装置被沿其纵向拉伸(见图5)。此凹瘪形状可通过沿其轴拉伸装置、如手工抓住夹角并将其拉开而很容易地实现,这将会使装置的松弛态直径向内趋向装置轴。可以在植入时把装置载入导管内,不需要预先装载导引器或导管。
如果本装置用于永久地阻塞患者体内的通道,则可以从患者体内简单地抽出导管并移去。这样留下应用在患者血管系统中的医疗装置,使得装置可以阻塞患者体内血管或其它通道。在有些情况下,医疗装置可以保证连结到输送装置端部的方式连结到输送系统。在此系统中移去导管之前,需要在移去导管和输送装置之前拆下医疗装置。
当本装置用在患者体内时,血栓趋于汇集在股线的表面。由于有更大的股线密度,所以股线的表面积将增大,装置的血栓活动性提高并允许相对迅速地阻塞应用该装置的血管的阻塞。相信由至少40的投梭和至少30的间距的4mm直径的管状编织形成阻塞装置将提供充分的表面积以基本上完全阻塞瓣膜壁中的不正常开口。如果需要增加装置阻塞的速度,可以对装置应用任何已知的血栓形成剂。本领域的技术人员将会理解,可以在其中任何一个或两个盘12和14中定位阻塞膜、纤维或格网来进一步增强每个盘的阻塞构造(见图3)。
以上对本发明做了详细描述,下面将对附图做具体地描述。这些附图举例说明了本发明的机构实施例,其中中央部分是弹性部分并把外盘拉向彼此。首先参见图1和图2,图中表示一种适于阻塞卵圆孔未闭(PFO)的装置10。在松弛的未拉伸状态(见图2)中,装置10一般包括由弹性中央部分16连结的两个准直盘12和14。多个编织线形成每个盘的外表面18和内表面20。每个盘的内表面20可以是凹形或杯状(也见图7),以便确保每个盘12和14的周边22和24分别接触瓣膜壁40。
当装置10处于松弛态时,盘12和14趋于叠盖并且中央部分16延伸到盘12和14的内表面形成的凹陷中。以此方式拉开盘12和14时,中央部分16的类似弹簧作用将导致相应盘的周边22和24完全与瓣膜的侧壁衔接(见图11和12)。图3~5顺序地表示完全的中央部分16的拉伸、类似弹簧作用。在装置10的形成中,没有任何有意的限定,管状编织(在形成中央部分16的区域)局部地变平坦,从而增强了中央部分16的类似弹簧作用。图6表示盘12和14可以通过拉伸中央部分16而横向偏移。
管状编织的金属纤维装置10的端部26和28与对应的夹具30和32焊接或夹在一起以避免擦伤。当然也可以通过本领域技术人员熟知的其它装置保持在一起。另外,应理解可以用其它合适的固定装置以其它的方式连结到端部26和28,如通过熔结、焊接、铜焊、使用生物相容的胶结材料或任何其它合适的形式。系结到绞合线相应端部26和28的夹具30和32也用于把装置连结到输送系统。在所示的实施例中,夹具30和32一般为圆柱形并有一个用于接收金属纤维端部26和28的螺栓芯34(见图7),从而避免股线彼此相对移动。螺栓芯34用于接收输送装置的螺栓远端并与其衔接。
图8~10表示装置10的附加实施例,其中弹性中央部分16的形状改变。中央部分16在其两侧及前后方向可弯曲。这种可弯曲性提供了装置的自为中心的特点,其中盘12和14趋于自动地以自身为中心环绕缺陷的邻近开口(见图11和12),同时趋于把盘拉向彼此。中央部分16可包括螺旋弹簧形状(见图9)、线圈形状(见图10)或弯曲的形状(见图2)。
本领域的技术人员将可理解,装置10的大小做成与待阻塞的旁路成比例。每个盘12和14的直径可依瓣膜壁中不同大小开口的需要而改变。另外,弹性中央部分的长度可根据瓣膜壁的厚度改变,变化范围在4~40mm之间。
PFO阻塞装置10可根据上述方法制造。该装置最好有0.005英寸的镍钛合金线网格制造。股线格网的编织可按每英寸28投梭、以大约64°的屏蔽角利用72个导线导轮的Maypole编织机执行。PFO装置10的硬度可通过改变股线的大小、屏蔽角、投梭大小、编织直径、导线导轮的数量或热处理过程而增大或减小。本领域的技术人员将从前述讨论中认识到模具腔的形状必须做成与PFO装置的理想形状一致。
当采用未处理的NiTi纤维时,绞合线将趋于恢复到未编织的结构,并且可以非常迅速地解开编织,除非相对于另一端束缚编织的长度端部。夹具30和32用于防止解开编织的任一端,由此有效地确定纤维密封长度以内的空间。这些夹具30和32将切削过的编织端部保持在一起并防止编织松解开。虽然已经证明NiTi合金的焊接和铜焊是非常困难的,但端部仍可以熔结到一起,如通过激光焊枪点焊。当切削纤维到理想的尺寸时,应特别小心确保纤维不松解开。例如,在NiTi合金形成管状编织的情况下,各个绞合线将趋于回复到它们的热置结构,除非受到约束限制。如果对编织热处理,将绞合线设置到编织的结构,则将趋于保持在编织形式,并且只有端部变得磨损。但可以更经济的简单地形成编织而不对编织热处理,因为在形成医疗装置时纤维还要经过热处理。
下面将关于阻塞PFO对本发明装置10的利用做更详细的描述。可以利用二维超声波心动描记法和多普勒彩色超声波来输送并确定适当装置。如上所述,输送装置可以取任何适当的形状,最好包括一个类似于传统导线的延长的挠性金属轴。输送装置用于经小直径的柱形管的腔向前输送PFO阻塞装置,如输送导管。利用加载护套把PFO装置10载入小直径的柱形管,以拉伸装置并将装置置于拉伸的或伸长的状态。在制造装置的过程或预组装期间可以把装置插入管腔中,当保持在压缩态时,本发明的装置不会采取永久的设置。
在股静脉方法中,输送导管或管通过PFO。装置10通过输送导管直到远端变成在导管端部的出口不受限制,因此假设左心房为盘状(见图13)。然后在穿过PFO的近端方向上拉回输送导管,并在近端的方向同样拉输送装置,使远盘顶着瓣膜。然后再从瓣膜拉开输送导管,使得近端盘能延伸出输送导管,在那儿弹性地回复到其预定的松弛的盘状。以这种方式定位PFO,使得远端盘压到瓣膜的一侧,而近端盘压到瓣膜的另一侧。欲增强其阻塞能量,装置可包含聚酯纤维或尼龙纤维(见图3)。例如,在装置不正确地应用在初次尝试时,可以通过近端拉输送装置而使装置回复,由此在第二次尝试把装置相对于缺陷定位之前把装置10抽回到输送导管中。
当PFO阻塞装置正确地放置时,医生转动导线,从阻塞装置10的夹角30或32中卸下导线远端的螺栓。夹角上的螺栓使得导线的转动从阻塞装置10的夹角卸下导线,而非仅仅转动阻塞装置。如上所述,螺栓夹角也能使操作者保持装置应用期间的固定,或能使操作者在装置的应用期间控制弹簧作用以确保正确地定位。
在此已对本发明做了详尽的描述以符合专利法的章程,并给本领域的技术人员提供应用新颖的原理所需要的信息,并按需要创建和利用实施例。但应理解本发明也可以通过具体的不同装置进行实施,并在不背离本发明范围的前提下实现各种改型。
Claims (9)
1.一种通过经皮导管定向的收缩阻塞装置,包括两个直径扩大部分和一个互连结两个直径扩大部分的弹性中央部分,所述装置有一个近端和一个远端,其中远端和近端中的至少一个包括把所述装置固定到输送系统的机构,所述装置还具有一种萎陷形状以使所述装置可经患者体内通道输送;所述弹性中央部分具有可弯曲性,通过弯曲该弹性中央部分就可使两个直径扩大部分彼此拉近,也可使一个直径扩大部分的中心轴偏离另一直径扩大部分的中心轴。
2.根据权利要求1所述的装置,其特征在于所述装置由一种多股编织的金属绞合线组成的连续管状金属纤维构成。
3.根据权利要求1所述的装置,其特征在于每一个直径扩大部分有一个内壁和外壁,以致至少一个直径扩大部分的内壁至少有局部地凹陷。
4.根据权利要求1所述的装置,其特征在于两个直径扩大部分之间的间隔小于患者心房瓣膜的厚度。
5.根据权利要求1所述的装置,其特征在于第一直径扩大部分的内表面至少部分地凹陷,并且弹性中央部分的长度大小使得第一直径扩大部分的周边叠盖第二直径扩大部分的周边。
6.根据权利要求1所述的装置,其特征在于用于固定的机构包括连结到输送装置的机构。
7.根据权利要求1所述的装置,其特征在于弹性中央部分的形状为螺旋形,由此把两个直径扩大部分拉向彼此。
8.根据权利要求1所述的装置,其特征在于弹性中央部分可以被弯曲,由此把两个直径扩大部分拉向彼此。
9.根据权利要求1所述的装置,其特征在于两个直径扩大部分由局部凹陷的第一直径扩大部分和局部凹陷的第二直径扩大部分构成。
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US09/019,620 US5944738A (en) | 1998-02-06 | 1998-02-06 | Percutaneous catheter directed constricting occlusion device |
US09/019,620 | 1998-02-06 |
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CN1283973A CN1283973A (zh) | 2001-02-14 |
CN1102373C true CN1102373C (zh) | 2003-03-05 |
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CN98813470A Expired - Lifetime CN1102373C (zh) | 1998-02-06 | 1998-10-12 | 通过经皮导管定向的收缩阻塞装置 |
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US (1) | US5944738A (zh) |
EP (3) | EP2263569A1 (zh) |
JP (1) | JP3524494B2 (zh) |
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CN (1) | CN1102373C (zh) |
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CA (1) | CA2319521C (zh) |
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ES (2) | ES2294820T3 (zh) |
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- 1998-02-06 US US09/019,620 patent/US5944738A/en not_active Expired - Lifetime
- 1998-10-12 CA CA002319521A patent/CA2319521C/en not_active Expired - Lifetime
- 1998-10-12 EA EA200000739A patent/EA002106B1/ru not_active IP Right Cessation
- 1998-10-12 AT AT98953347T patent/ATE372727T1/de active
- 1998-10-12 EP EP10075489A patent/EP2263569A1/en not_active Withdrawn
- 1998-10-12 JP JP2000530153A patent/JP3524494B2/ja not_active Expired - Lifetime
- 1998-10-12 PT PT98953347T patent/PT1052944E/pt unknown
- 1998-10-12 KR KR10-2000-7008508A patent/KR100400506B1/ko active IP Right Grant
- 1998-10-12 ES ES98953347T patent/ES2294820T3/es not_active Expired - Lifetime
- 1998-10-12 EP EP98953347A patent/EP1052944B1/en not_active Expired - Lifetime
- 1998-10-12 WO PCT/US1998/021342 patent/WO1999039646A1/en active IP Right Grant
- 1998-10-12 CN CN98813470A patent/CN1102373C/zh not_active Expired - Lifetime
- 1998-10-12 EP EP07014279.9A patent/EP1844717B1/en not_active Expired - Lifetime
- 1998-10-12 DE DE69838436T patent/DE69838436T2/de not_active Expired - Lifetime
- 1998-10-12 DK DK98953347T patent/DK1052944T3/da active
- 1998-10-12 ES ES07014279T patent/ES2431563T3/es not_active Expired - Lifetime
-
2001
- 2001-05-23 HK HK01103575A patent/HK1032892A1/xx not_active IP Right Cessation
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---|---|
EP1052944A1 (en) | 2000-11-22 |
KR20010040637A (ko) | 2001-05-15 |
DE69838436T2 (de) | 2008-06-12 |
JP3524494B2 (ja) | 2004-05-10 |
CA2319521A1 (en) | 1999-08-12 |
EA200000739A1 (ru) | 2001-04-23 |
EP2263569A1 (en) | 2010-12-22 |
CA2319521C (en) | 2004-05-04 |
EP1844717A3 (en) | 2008-09-24 |
EP1844717B1 (en) | 2013-08-28 |
EP1052944A4 (en) | 2006-06-14 |
AU737934B2 (en) | 2001-09-06 |
EP1052944B1 (en) | 2007-09-12 |
WO1999039646A1 (en) | 1999-08-12 |
EA002106B1 (ru) | 2001-12-24 |
PT1052944E (pt) | 2007-10-12 |
DK1052944T3 (da) | 2007-11-05 |
ES2431563T3 (es) | 2013-11-27 |
KR100400506B1 (ko) | 2003-10-08 |
ES2294820T3 (es) | 2008-04-01 |
JP2002502625A (ja) | 2002-01-29 |
HK1032892A1 (en) | 2001-08-10 |
AU1074899A (en) | 1999-08-23 |
CN1283973A (zh) | 2001-02-14 |
EP1844717A2 (en) | 2007-10-17 |
DE69838436D1 (de) | 2007-10-25 |
ATE372727T1 (de) | 2007-09-15 |
US5944738A (en) | 1999-08-31 |
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