CN1399531A - 左心房附件口的阻挡装置 - Google Patents
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Abstract
本发明涉及一种用于心房附件口、阻挡血液进入心房附件而可能在其中形成血块的隔膜。隔膜还防止心房附件中的血块离开并进入血流而可能导致血管阻塞和心脏病发作。隔膜经由皮肤安装在患有心房纤维性颤动以及心房附件中可能形成血栓的其它心脏疾患的患者体内。本发明涉及各种使隔膜固定就位的装置。隔膜可以固定在心房附件口上,或者填充心房附件内部。使隔膜固定在心房附件口上的装置包括插脚、移植片固定物、具有系绳或弹簧的锚固件、具有系绳或弹簧的盘形件、伞形件、填充心房附件的螺旋弹簧、以及粘合剂。隔膜固定就位后,一种填料物质可以注入到心房附件内以缩小其空间,有助于隔膜密封在附件口上或使心房附件中的血液凝结。隔膜可以具有抗血凝剂以防血栓形成。隔膜可以具有气孔,使内皮细胞覆盖隔膜而成为一种“活”隔膜壁,以防血栓形成。隔膜可以具有使隔膜对中定位在附件口上的装置。传感器可以固定在隔膜上,以提供关于患者的信息。
Description
技术领域
本发明涉及一种应用于心房附件口的隔膜或插塞装置,这种装置用于防止在一个心房和相连的心房附件之间的血液流动和生理连接,以隔开一个心房附件,防止血栓离开该心房附件。
背景技术
有许多心脏病(例如冠状动脉病、二尖瓣病)对心脏具有各种各样的有害作用。某些心脏病例如二尖瓣病的一个有害作用是心房纤维性颤动。心房纤维性颤动可以在左心房附件中造成淤血。淤血也可以是自发的。当血液淤积在心房附件中时,血块可以在其中形成、积累、增大并从心房附件散布到心房中。这些血块如果从心房附件转移,在血流中自由流动,从末端进入动脉系统,则可以进入体循环或肺循环,导致严重疾患。当一个从一个心房附件延伸到一个心房的血块断开并进入血液供给系统时,也会发生类似的疾患。由于来自左心房和心室的血液供给心脏和脑,因此,来自心房附件的血块可以阻止血液流入而导致心脏病发作或其它器官局部缺血。因此,必须研究出一种装置防止血块在心房附件中形成,防止形成后的血块离开心房附件进入患者的心脏、肺、脑或其它循环而导致心脏病发作或其它器官局部缺血。
专利5865791涉及缩小血液郁滞区域并最终减少在这些区域尤其是在患有心房纤维性颤动的患者的心房附件中形成血栓。更具体地说,该发明涉及沿着一个防止随后形成血栓的方向固定心房附件的方法和装置。该发明提出从心房摘除附件,其方法是,拉住心房附件,围绕它放置一个环形件,形成一堆心房附件,然后从心脏的其余部分上将其切除。
专利5306234涉及一种通过外科手术封闭心房和心房附件之间的通道或者切除心房附件的方法。
其它治疗方法包括通过外科手术摘除心房附件,以防血液郁滞在心房附件中。
发明内容
本发明提出一种隔膜或插塞装置,这种装置防止血液进入心房附件形成血块以及防止在心房附件中形成的血块离开心房附件而导致心脏病发作或其它栓塞疾患。隔膜覆盖心房附件口,使之与心房有效隔离。隔膜可以大于心房附件口,在大于附件口的一个区域上延伸。隔膜由一个导管经由皮肤输送到心房附件口,然后膨胀以覆盖附件口,有一个装置使隔膜固定在附件口上。隔膜本身可以是气孔式或非气孔式的。如果是一种气孔隔膜,则细胞可以通过,因此成为一个“活”装置,可以形成一种内皮/心内膜衬料使之再成为一个不形成血栓的表面。有许多固定隔膜使之覆盖附件口的装置。隔膜固定装置具有一个使隔膜自对中定位在附件口上的装置。隔膜可以粘接,或者具有通过附件口延伸到心房附件中的一个移植片固定物(stent)或插脚。另一方面,心房附件壁上的一个锚固件可以系到隔膜上,使隔膜固定就位。弹簧也可以延伸在锚固件和隔膜之间,使隔膜固定到附件口上。隔膜也可以与一根系绳、弹性系绳或弹簧相连接并通过心房附件壁加以布置,使隔膜固定到附件口上,而且可以拉住心房附件,使其空间缩小或消除,密封和隔离其中的血块。凝血酶、活性血纤维蛋白原或其它生物填料可以在心房附件被密封后置于心房附件中,其特殊目的是为了使血液在心房附件中凝结,此外还防止血块离开心房附件。
装置的一部分可以包括一个去除已形成血块的吸取装置。隔膜的布置可能需要封闭由于布置这种心房闭合装置而造成的心房中隔缺陷。
另一方面,隔膜可以由一个填充心房附件空间的盘簧固定就位。隔膜也可以填充心房附件本身,以防止血液进入,或防止血块离开。
隔膜本身可以是气孔式或非气孔式的。如果是一种气孔隔膜,则细胞可以渗入,因此成为一个“活”装置,可以形成一种内皮/心内膜衬料使之再成为一个不形成血栓的表面。因此,可以形成一种内皮,随着时间的推移,具有高度生物兼容性。隔膜布置后可以立即涂覆肝素,以防在隔膜表面形成血栓,直至细胞渗入和/或形成一层内皮覆盖层。
装置植入心房附件时,也可以对心脏进行电监测。两个或多个电触点分开布置在装置上,并且同信号调节电路相连接,测定心脏特征例如心房或心室的节律。装置上的另一个传感器可以测定心房、心房附件或心室的压力以及通过开放的二尖瓣或三尖瓣的舒张压(左或右)。使用一个适当的遥测系统在患者体外无损害地遥测该重要的血压电信息。装置上可以配置存储器,记录信息,以便以后通过无损害遥测技术进行收集。
该装置也可以用于封闭体内其它部位例如结肠系统或者支气管肺系统的瘘或联系。该装置的另一个用途是将隔膜固定到左心室的假动脉瘤上使之密封和强化。凡是隔膜固定到瘘或假动脉瘤上,都采用相同的原理,隔膜由弹簧或插脚机构加以固定就位。
装置也可以用于使用化学制剂烧蚀心房附件中的心肌组织,以便限制或消除心房纤维性颤动的电传播。
本发明旨在缩小心房附件的空间,缩小血淤形成的潜在区域,从而缩小有疾患的心房的有效空间。
本发明旨在测定心脏的血压(或血流量)或者电信号,在体外对它们进行遥测,以供诊断或监测。
本发明旨在封闭体内其它部位例如结肠系统或者支气管肺系统的瘘或联系。
本发明旨在将隔膜置于一个假动脉瘤上使之强化,以避免外科手术。
本发明旨在缩小心房附件中血液郁滞区域,从而减小心房中形成血栓的可能性。
本发明旨在防止血块在心房附件中形成。
本发明旨在用一个不形成血栓的生物兼容表面置于心房附件口上,该表面防止血块形成。
本发明旨在提出一种衬有内皮或内心膜细胞的气孔隔膜表面。
本发明旨在使心房附件与心房本身隔离,防止连通而可能转移血栓。
本发明旨在尽量无损害地防止血块在心房附件中形成并离开心房附件。
本发明旨在提出一种置于心房和心房附件之间的过滤器,防止血块在两者之间流动。
本发明旨在用一种材料填充心房附件,防止血块离开心房附件。
本发明旨在通过吸取或其它方法从心房去除血栓。
本发明旨在提出一种使移植有细胞的一个隔膜紧固到心房附件口上,并提出一种包括但不限于内皮化的高度生物兼容表面。
本发明旨在通过将肝素或其它抗血栓形成物质使用到隔膜上或者从隔膜洗脱,防止血栓。
本发明旨在用一种注入到心房附件中的物质密封隔膜。
本发明旨在在隔膜固定就位之后,用一种注入到心房附件中的物质使心房附件中的血液凝结。
本发明旨在将一种物质注入到密封的心房附件中,烧蚀心房附件的心肌细胞,以限制心房纤维性颤动的传播。
本发明旨在确保隔膜对中定位在心房附件口上。
本发明旨在精确地将隔膜置于心房附件口上。
附图说明
参照附图和非限制实施例,本发明的其它目的、优越性和特征将得到更好地理解。
图1是心脏的局部剖面图,示出一个导管采用逆行法从主动脉进入左心房附件。
图2是心脏的局部剖面图,示出一个导管采用穿过中隔法从股静脉或上腔静脉进入左心房附件。
图3是心脏的局部剖面图,示出一个导管从颈静脉或者可选地从股静脉进入右心房附件。
图4是一部分心脏的局部剖面图,示出一个心房及其相连的心房附件。
图5是一部分心脏的局部剖面图,示出一个心房及其相连的心房附件,一个气孔隔膜具有使隔膜固定就位的挠性金属线插脚,插脚具有无损伤球形件,电子元件安装在隔膜上。
图6类似于图5,挠性金属线插脚没有无损伤球形件,因此可以刺穿心房壁,确保隔膜固定在心房附件上,隔膜还配有一个对中定位凸缘。
图7是图5所示一部分心脏的局部剖面图,隔膜和插脚之间具有一个移植片固定物。
图8与图7相同,挠性金属线插脚没有无损伤球形件,因此可以刺穿心房壁,确保隔膜固定在心房附件上。
图9是一部分心脏的局部剖面图,示出一个心房及其相连的心房附件,一个气孔隔膜具有一个大的使隔膜固定就位的可膨胀移植片固定物。
图10是一部分心脏的局部剖面图,示出一个心房及其相连的心房附件,一个锚固件和一根系绳将隔膜固定就位。
图11是一部分心脏的局部剖面图,示出一个心房及其相连的心房附件,一个锚固件和一个弹簧将隔膜固定就位,隔膜上配有一个对中定位凸缘,还配有一个对中定位索。
图12与图11相同,填充心房的弹簧有助于使隔膜固定就位。
图13是一部分心脏的局部剖面图,示出一个心房及其相连的心房附件,隔膜以粘接方式固定就位。
图14是一个输送导管的局部剖面图,导管中装有一个盘形件、一个弹簧和一个隔膜。
图15是从图14所示导管中输出的膨胀后的盘形件、弹簧和隔膜的示意图。
图16是一部分心脏的局部剖面图,示出一个心房及其相连的心房附件,其间具有一个盘形件、一个隔膜和一个弹簧。
图17是一部分心脏的局部剖面图,示出处于压缩位置的一个心房及其相连的心房附件。
图18是一部分心脏的局部剖面图,示出一个心房及其相连的心房附件,其中具有一个盘形件、一个弹簧、一个隔膜以及导管所配有的真空装置。
图19是一部分心脏的局部剖面图,示出一个心房及其相连的心房附件,一种隔膜材料填充心房附件。
图20是一部分心脏的局部剖面图,示出一个心房及其相连的心房附件,并示出一个用于进入心房附件的折叠的伞形件。
图21是一部分心脏的局部剖面图,示出一个心房及其相连的心房附件,伞形件在心房附件中打开,确保伞形件固定在心房附件壁上。
图22是一部分心脏的局部剖面图,示出一个心房及其相连的心房附件,伞形件和隔膜已密封心房附件口。
图23是一部分心脏的局部剖面图,示出一个心房及其相连的心房附件,一个移植片固定物具有一个阻挡心房附件口的隔膜。
图24是一部分心脏的局部剖面图,示出一个心房及其相连的心房附件,由于一个盘形件和弹簧将心房附件挤压在一个隔膜上,因此,心房附件被压缩到最小空间。
具体实施方式
虽然心房纤维性颤动导致左心房淤血,本发明在多数情况下用于左心房附件,但是,本发明也可以用于右心房附件,一般来说,用于体内任何需要阻塞以防血液从那里流通或流出的孔口。
如图4所示,当患者患有心房纤维性颤动时,由于血液流通不畅,在左心房附件13中可能出现淤血而形成一个血栓30。为了防止血栓30在左心房附件13中形成,或者防止在那里形成的血栓离开而进入血流从而可能导致心脏病发作或局部缺血,一个隔膜40置于心房附件13的口20上。隔膜40可以用特氟隆、毛毡、涤纶、硅氧烷聚氨酯、Gortex、金属纤维或生物兼容聚合物制成。
隔膜40可以是一种气孔隔膜。气孔隔膜可以由一种有气孔的生物兼容聚合物所构成,气孔大小为20至100微米。气孔在很少情况下可以大一些或小一些。隔膜也可以是一种允许细胞在内生长并覆盖有内皮细胞的有气孔的金属或细纤维金属网。隔膜可以涂覆有抗血凝剂,或者洗脱抗血凝剂。
气孔隔膜从心脏移植细胞,从而形成壁以堵塞口20,这样,血液不能流入左心房附件13形成血栓30,更为重要的是,形成的血栓30不能离开左心房附件13而导致心脏病发作或局部缺血。
置于口20上的隔膜40应该抗血栓形成。为了使隔膜抗血栓形成,肝素或者其它抗血凝剂或抗血小板剂可以用于隔膜40。
使用气孔隔膜40时,具有在内生长的细胞以内皮细胞覆盖隔膜,内皮细胞具有光滑的细胞壁覆盖隔膜,在隔膜处防止血栓形成。
血液淤积在左心房附件13中时,血栓30(血块)可以在其中累积、增大,并从左心房附件13扩散到左心房11,进入血流,离开心脏,如果驻留在其动脉中,则可以阻挡血液流到心脏、脑、其它器官或周围的血管。
图1和2是一个人体心脏的剖面图,示出左心房附件13中的一个血栓30。图中还示出心房附件口20,一个隔膜40置于该附件口上,以防血栓30离开心房附件13,进入左心房11,从而进入血流,可能导致心脏病发作或局部缺血。隔膜40还防止血液进入左心房附件13,由于血流不畅而在那里淤积成为血栓。
图3是一个人体心脏的剖面图,示出右心房附件23中的一个血栓30。右心房附件23可以如同左心房附件13一样加以处理。
图4是左心房11、附件口20和左心房附件13的剖面图,左心房附件13中具有一个血栓30。
图5示出本发明第一实施例,其中,气孔隔膜40具有挠性插脚50,插脚50可以用一种形状记忆合金例如镍钛金属互化物制成,以保持一种预先处理的形状。插脚50可以是无损伤的,以致于不刺穿左心房附件13。插脚50可以在其端头具有无损伤球形件55,使得插脚50的端头不会刺穿左心房附件13。镍钛金属互化物具有能够在导管中处于紧密构形状态而当从导管松开时则膨胀到预定记忆形状的特性。所选形状可以使插脚50围绕附件口20的唇部弯曲,然后紧靠在左心房附件13的侧面上。这样,隔膜40会安全地阻挡附件口20,以防血液进入,尤其是防止血栓30离开左心房附件13。
隔膜40自对中定位在左心房附件13的口20上,由于插脚50围绕隔膜40布置成一个圆,因此,插脚50在附件口20的唇部或其内紧靠左心房附件13的壁,使隔膜40对中定位在附件口20上。隔膜40也可以通过一个对中定位凸缘65(见图6)进行对中定位,该定位凸缘固定到隔膜40的背面(附件)上,伸进附件口20以进行对中定位。对中定位凸缘65的直径小于隔膜40的直径。对中定位件也可以由一组对中定位锚固件66(见图11)构成,这些锚固件固定到来自对中定位凸缘65或隔膜40的一个弹簧90或一根系绳85上,确保对中定位。
可选的是,隔膜上装的电子元件例如传感器300和芯片310可以用于提供关于血液动压、血流速率、温度、心博率以及心脏电信号的数据。当隔膜置于左心房附件13中时,传感器300可以测定心房或心房附件中的压力。传感器也可以测定通过开放的二尖瓣的心室压力和舒张压。也可以收集其它关于心脏的信息例如加速计的噪音来测定漏出、瓣的效率、患者的活动程度以及其它与噪音有关的数据。传感器300也可以是血氧传感器。芯片310可以采用遥测技术将传感器300收集的由芯片310处理或存储的信息传送到接收装置,协助对患者的治疗。
如图6所示,保护性球形件55从图5所示的挠性插脚50去除,使挠性插脚50刺穿左心房附件13的壁,确保隔膜40固定就位。挠性插脚50可以进入心房附件壁或穿过心房附件壁进行延伸。插脚可以具有倒刺端部51,以防插脚脱离心房附件壁。
隔膜40具有附属的对中定位凸缘65,用于使隔膜对中定位在附件口20上,隔膜40上的指示器320用于插入隔膜时观察其位置。指示器可以用于进行X线或超声波观察。
虽然前面述及可以使用镍钛金属互化物作为一种形状记忆合金插脚材料,但是,可以采用任何类型的记忆合金。这些合金具有温度感应相变特性,当加热到一定的转变温度以上时,会使材料具有最佳构形。其它可以用作插脚的金属包括耐蚀弹簧金属例如埃尔基洛伊耐蚀游丝合金或者弹簧回火钢。
本发明另一个实施例示于图7。该实施例类似于图5所示的实施例。图7所示的实施例具有一个移植片固定物60,该固定物固定在隔膜40上,用于在附件口20中延伸,以确保隔膜40固定在附件口20上。插脚50如同图5所示的那样,紧靠在左心房附件13的内壁上,确保隔膜40覆盖附件口20。移植片固定物60也可以用镍钛金属互化物、埃尔基洛伊耐蚀游丝合金(Elgiloy)或者其它膨胀弹簧材料或轻型膨胀材料。
由于移植片固定物60插入到左心房附件13的口20中,而隔膜40对中定位在所述固定物上,因此,隔膜40可以自对中定位在所述附件口上。而且,插脚50在附件口20的唇部或其内紧靠左心房附件13的壁,使隔膜40对中定位在附件口20上。
在图8中,保护性球形件55从图7所示的挠性插脚50去除,使挠性插脚50刺穿左心房附件13的壁,确保隔膜40固定就位。挠性插脚50可以进入心房附件壁或穿过心房附件壁进行延伸。插脚可以具有倒刺端部51,以防插脚脱离心房附件壁。
在图9所示的实施例中,一个大的移植片固定物70用于既同附件口20的侧面相接合,又紧靠在左心房附件13的内壁上。同样,移植片固定物可以用镍钛金属互化物、埃尔基洛伊耐蚀游丝合金或其它可在导管中输送并膨胀到适当尺寸和形状的材料制成,安全可靠地使隔膜40保持在附件口20上,以防血液进入左心房附件13,并且防止血栓30形成。
图10示出本发明另一个实施例,其中,隔膜40通过一个锚固件80紧固在附件口20上,所述锚固件进入或穿过左心房附件13的壁,通过锚固件的表面区域紧固在那里,使之不脱离左心房附件13的壁,以防在左心房附件13中形成栓塞。一根系绳85固定到锚固件80和隔膜40上,确保隔膜40恰好紧靠在附件口20上。一种物质270例如凝血酶、活性血纤维蛋白原或其它生物填料可以在隔膜40固定就位后通过一个导管注入左心房附件13中,使血液在心房附件中凝结而不能排出。装置输送导管本身可以具有一个进行这种注入的注入口。注入口也可以用于注入造影剂例如心脏回波检查造影剂,这种造影剂可以立即观测到,经分析可确定附件口和装置之间是否密封良好。注入心房附件的物质270也可以是一种使隔膜密封以防从心房附件漏出的密封剂或填料。本发明任何实施例均可使用密封剂材料、填料材料或血凝材料。
在其它实施例中,导管可以注入一种化学烧蚀剂例如乙醇,对密封的心房附件13中的心肌细胞进行烧蚀,从而由于限制或消除心房附件中的电传播而限制心房纤维性颤动。
图11示出本发明另一个实施例,其中,隔膜40除了锚固件80之外还具有一个螺旋弹簧90。螺旋弹簧90可以同系绳85一起使用或分开使用,将隔膜40牵拉在附件口20上。虽然图9已经示出一种螺旋弹簧90,但是,所采用的形状可以是椭圆形、圆柱形、长方形或其它形状,使锚固件80与隔膜40相连接。在图12所示的另一个实施例中,螺旋弹簧90可以填充左心房附件13的空间,确保隔膜40紧固在附件口20上。填充左心房附件13空间的螺旋弹簧90也可以具有一个锚固件80和一根系绳85,使隔膜40紧固在附件口20上。另一方面,如图11所示,可以采用对中定位凸缘65,使隔膜40对中定位在左心房附件13的口20上。可以使用同螺旋弹簧90以及同隔膜40或对中定位凸缘65相连接的对中定位锚固件66,使隔膜40对中定位在附件口20上。
图13示出隔膜40紧固到附件口20上的另一个方法。在该实施例中,隔膜40用一种粘合剂100直接粘合到附件口20上。
图14示出一个输送导管125,导管125内装一个压缩的气孔隔膜40和一个压缩的盘形件130,隔膜40和盘形件130在导管21上由一个螺旋弹簧90加以连接。盘形件130可以由一种挠性金属编织件或一种具有一薄层气孔聚合物内夹层的挠性金属编织件制成。盘形件130也可以是一种聚合物编织件。盘形件130呈挠性,可以压缩或折叠,因此适于装入输送导管125中,并且在从输送导管125中松开后膨胀到所需的形状。同样,隔膜40可以压缩或折叠,适于装入输送导管125中,并且在松开后膨胀到所需的形状。图15示出图14所示的在输送导管125之外处于膨胀构形的气孔隔膜40、盘形件130和弹簧90。
图15示出使气孔隔膜40与盘形件130相连接的弹簧90。在其它实施例中,也可以使用一根弹性系绳或一根在气孔隔膜40上具有齿和一个棘爪以形成一个棘轮机构的系绳,将气孔隔膜40和盘形件130牵拉在一起。
图16示出图15所示的装置应用于具有血栓30的左心房附件13。在装置装上之后,弹簧90将盘形件130拉向气孔隔膜40,压缩左心房附件13,将血栓30阻挡在其中,如图17所示。
图18示出图16和17所示装置的其它实施例,其中,导管21配有一个真空装置140,用于吸出在左心房附件13中发现的血液和血栓30。真空装置140有助于压缩左心房附件13,因此,弹簧90无需如同图16所示的那样大。
图19示出装置的其它实施例,其中,隔膜150插入并填充左心房附件13,使隔膜150紧固在其中。隔膜150可以作为一种压缩材料在一个导管中进行输送并且在心房附件13中膨胀,或者以一种液体方式进行输送,填充心房附件,再用另一种由导管输送的化学制剂进行固化,或者借助于通过导管21中的一根纤维光缆提供的紫外线进行固化,转变成一种隔膜。用一种隔膜材料150填充左心房附件13,血液就不能进入而淤积成为血栓30,也就不会形成血栓30而导致心脏病发作和局部缺血。
图20至22示出本发明另一个实施例,该实施例采用伞的原理使隔膜40紧固到附件口20上。图20示出闭合的伞撑160进入左心房附件13的口20中。隔膜40从伞撑160向后一定距离,在伞柱170上位于齿195分布区的底部。图21示出位于左心房附件13之内的伞撑,伞撑160呈打开状态。伞柱170上的伞开启件175将伞撑推出到伞打开位置。伞开启件175可以被推到打开位置,或者具有一个弹簧机构将伞撑160推到打开位置。伞撑160的端部围绕附件口20同左心房附件壁相接合,以防伞形件脱离左心房附件13。与心房附件壁相接合的伞撑160的端部可以钝化,或在端头具有球形件,或具有衬垫,因此不刺穿左心房附件13。图22示出通过棘轮机构使隔膜40沿着伞柱170移动到附件口20上。棘爪机构200在伞柱170上与齿195啮合,向前移动,使隔膜40恰好阻挡附件口20。
图23示出一个贴靠在左心房附件13的口20上的移植片固定物260。固定物260在离开输送导管之后进行膨胀,这样,固定物的壁使固定物密封地紧固在附件口20上。隔膜40折叠或压缩到输送导管中,随着固定物260膨胀而膨胀,并固定在左心房附件13的口20中。
图24示出心房附件被压缩到基本没有空间的左心房附件13。由于空间被缩小,心房附件就没有较大的可以形成血栓的血液空间。在所示的实施例中,盘形件130和弹簧90将左心房附件13拉向隔膜40。虽然图24示出使用盘形件130和弹簧90作用于左心房附件,但是,可以采用任何尽量缩小心房附件空间的方法。除了直接缩小空间外,也可以将一种物质270注入到心房附件中,进一步限制其空间,或者使已经存在在其中的血液凝结。
如图24所示,隔膜40比附件口20大得多。在所有实施例中,均可使用大尺寸的隔膜40,以确保附件口20完全被阻挡。
上述一些装置可以经由皮肤分别输送到左右心房附件13、23。这些装置中可以具有一些增强通过超声波、X线或其它方法进行造影或成象效果的材料,使装置更容易植入并精确地对中定位在心房附件13的口20上。可以在隔膜上、在连接件上或者在锚固件上在关键部位布置一些小珠。由图1可见,导管21经主动脉12到左心室16进入心脏,通过二尖瓣17,然后进入左心房附件13放置上述实施例之一中所述的气孔隔膜40。在图2中,导管21从股静脉进入心脏,通过下腔静脉18到右心房,然后通过卵圆窝19或通过中隔29进入左心房11,然后接近左心房附件13放置气孔隔膜40。图3示出导管21进入右心房附件23的情况。导管21可以通过颈静脉28或股静脉到下腔静脉18进入心脏。
显然,本发明可以采用许多固定方法使隔膜40覆盖心房附件13和23的口20。使用粘合剂、插脚、移植片固定物、锚固件、盘形件、系绳或弹簧的固定方法可以进行任意组合。隔膜也可以置于心房附件13和23之内,或者可以填充心房附件,并配置一种确保隔膜锁紧就位的装置。也可以采用其它未列出的装置使隔膜阻挡血液流入心房附件和阻挡血块离开心房附件。可以将一种物质注入心房附件,以限制其空间,或者使已经存在的血液凝结。
在上述所有实施例中,可以促使心房附件的血液凝结以形成一个固定的大血块。另一方面,心房附件可以填充任何占据空间的物质,例如血纤维蛋白、辅基聚合物(PLLA)、硅氧烷聚合物或者一种输送就位并长时间保持就位的轻型材料。
所有上述用于左心房附件13的实施例也可以用于右心房附件23。另外,本发明可以用于封闭体内其它部位例如结肠系统或支气管肺系统的瘘或联系。本发明也可以用于密封假动脉瘤。当隔膜用于密封假动脉瘤时,将使之强化,并可避免外科手术。
显然,可以根据上述一些技术对本发明进行许多改进并提出其它一些实施例。因此,在所附权利要求书的范围内,除了以上所述之外,还可以在其它情况下实施本发明。
Claims (82)
1.一种防止心房附件血栓进入血流的方法,它包括:用一个隔膜阻挡一个心房附件口,防止血液进入心房附件而在其中形成血栓,并且防止在其中形成的血栓离开。
2.根据权利要求1所述的防止心房附件血栓进入血流的方法,其特征在于,它还包括:使插脚从隔膜穿过附件口延伸进心房附件,将隔膜固定在心房附件口上。
3.根据权利要求2所述的防止心房附件血栓进入血流的方法,其特征在于,它还包括:用延伸进心房附件的插脚刺穿心房附件壁,使隔膜固定就位。
4.根据权利要求2所述的防止心房附件血栓进入血流的方法,其特征在于,它还包括:将球形件固定在插脚的端部上,以防刺伤心房附件内部而导致栓塞。
5.根据权利要求2所述的防止心房附件血栓进入血流的方法,其特征在于,它还包括:通过呈一个圆固定在隔膜上的插脚将隔膜对中定位在附件口上,因此,插脚使隔膜定位在附件口上而在附件口和隔膜之间不留间隙。
6.根据权利要求2所述的防止心房附件血栓进入血流的方法,其特征在于,它还包括:使一个移植片固定物延伸在隔膜和插脚之间,与心房附件口相接合,以便将隔膜固定在附件口上。
7.根据权利要求6所述的防止心房附件血栓进入血流的方法,其特征在于,它还包括:用延伸进心房附件的插脚刺穿心房附件壁,使隔膜固定就位。
8.根据权利要求1所述的防止心房附件血栓进入血流的方法,其特征在于,它还包括:使移植片固定物的插脚穿过心房附件口延伸进心房附件,使隔膜恰好抵住心房附件口,从而将隔膜固定在心房附件口上。
9.根据权利要求1所述的防止心房附件血栓进入血流的方法,其特征在于,它还包括:使一个锚固件延伸进或穿过心房附件壁,在心房附件和隔膜之间固定一根系绳,使隔膜恰好抵住心房附件口,从而将隔膜固定在心房附件口上。
10.根据权利要求9所述的防止心房附件血栓进入血流的方法,其特征在于,它还包括:使用一根弹性系绳将隔膜密封在心房附件口上。
11.根据权利要求1所述的防止心房附件血栓进入血流的方法,其特征在于,它还包括:将一个锚固件插入心房附件壁,在锚固件和心房附件之间固定一个弹簧,使隔膜抵住心房附件口,从而将隔膜固定在心房附件口上。
12.根据权利要求1所述的防止心房附件血栓进入血流的方法,其特征在于,它还包括:使用一个同隔膜相连接的螺旋弹簧恰好填充心房附件,将隔膜密封在心房附件口上。
13.根据权利要求1所述的防止心房附件血栓进入血流的方法,其特征在于,它还包括:将隔膜粘接在心房附件口上。
14.根据权利要求1所述的防止心房附件血栓进入血流的方法,其特征在于,它还包括:使一个盘形件延伸穿过心房附件壁,在心房附件和隔膜之间固定一根系绳,使隔膜恰好抵住心房附件口,从而将隔膜固定在心房附件口上。
15.根据权利要求14所述的防止心房附件血栓进入血流的方法,其特征在于,它还包括:使用一根弹性系绳,使隔膜恰好抵住心房附件口。
16.根据权利要求1所述的防止心房附件血栓进入血流的方法,其特征在于,它还包括:使一个盘形件延伸穿过心房附件壁,在心房附件和隔膜之间固定一个弹簧,使隔膜恰好抵住心房附件口,从而将隔膜固定在心房附件口上。
17.根据权利要求1所述的防止心房附件血栓进入血流的方法,其特征在于,它还包括:用真空装置排空心房附件,从中去除血栓,并且压缩心房附件。
18.根据权利要求1所述的防止心房附件血栓进入血流的方法,其特征在于,它还包括:用一种隔膜材料填充心房附件,阻挡心房附件口。
19.根据权利要求1所述的防止心房附件血栓进入血流的方法,其特征在于,它还包括:使一个伞柱上的伞撑在处于闭合位置时延伸进心房附件,在心房附件中打开这些伞撑,这样,伞撑与心房附件壁相接合而不能从附件口抽出,然后使隔膜在伞柱上移动,在附件口对面固定就位,将附件口壁保持在隔膜和伞撑之间,从而将隔膜固定在心房附件口上。
20.根据权利要求1所述的防止心房附件血栓进入血流的方法,其特征在于,它还包括:使一个可折叠的移植片固定物延伸进附件口,这样,固定物膨胀并与附件口的周边相接合,将一个可折叠的隔膜固定在固定物的管腔上,这样,打开固定物,使隔膜在固定物的管腔上展开,阻挡附件口,从而将隔膜固定在心房附件口上。
21.根据权利要求1所述的防止心房附件血栓进入血流的方法,其特征在于,它还包括:用一种抗血凝药物涂覆隔膜,以防血栓形成。
22.根据权利要求1所述的防止心房附件血栓进入血流的方法,其特征在于,它还包括:使用一个促使内皮细胞在隔膜上生长的气孔隔膜,从而在隔膜上形成一个防止血栓形成的细胞壁。
23.根据权利要求1所述的防止心房附件血栓进入血流的方法,其特征在于,它还包括:将一种密封材料注入心房附件,使隔膜密封在附件口上,以防漏出。
24.根据权利要求1所述的防止心房附件血栓进入血流的方法,其特征在于,它还包括:将一种填料注入心房附件,缩小心房附件的空间。
25.根据权利要求1所述的防止心房附件血栓进入血流的方法,其特征在于,它还包括:将一种血凝物质注入心房附件,使血液在其中凝结,以防流出心房附件。
26.根据权利要求1所述的防止心房附件血栓进入血流的方法,其特征在于,它还包括:将一种化学烧蚀剂注入心房附件,烧蚀心肌组织,从而防止心房纤维性颤动的电传播。
27.根据权利要求1所述的防止心房附件血栓进入血流的方法,其特征在于,它还包括:使用一个对中定位装置,将隔膜对中定位在心房附件口上,以形成良好密封。
28.根据权利要求27所述的防止心房附件血栓进入血流的方法,其特征在于,使隔膜对中定位在附件口上的对中定位装置包括:将一个对中定位凸缘固定在隔膜上,用于插入到心房附件口中。
29.根据权利要求27所述的防止心房附件血栓进入血流的方法,其特征在于,使隔膜对中定位在附件口上的对中定位装置包括:
将一个对中定位凸缘固定在隔膜上,用于插入到心房附件口中,
将一个定位件固定到心房附件壁上,使定位件与一个位于定位件和隔膜之间的弹簧相连接,使隔膜抵住心房附件口,
将定位索从弹簧系到隔膜上,使隔膜对中定位在心房附件口上。
30.根据权利要求27所述的防止心房附件血栓进入血流的方法,其特征在于,使隔膜对中定位在附件口上的对中定位装置包括:
将一个对中定位凸缘固定在隔膜上,用于插入到心房附件口中,
将一个定位件固定到心房附件壁上,使定位件与一个位于定位件和隔膜之间的弹簧相连接,使隔膜抵住心房附件口,
将定位索从弹簧系到隔膜的对中定位凸缘上,使隔膜对中定位在心房附件口上。
31.根据权利要求27所述的防止心房附件血栓进入血流的方法,其特征在于,使隔膜对中定位在附件口上的对中定位装置包括:
将一个定位件固定到心房附件壁上,使定位件与一个位于定位件和隔膜之间的弹簧相连接,使隔膜抵住心房附件口,
将定位索从弹簧系到隔膜上,使隔膜对中定位在心房附件口上。
32.根据权利要求27所述的防止心房附件血栓进入血流的方法,其特征在于,使隔膜对中定位在附件口上的对中定位装置包括:
将一个对中定位凸缘固定在隔膜上,用于插入到心房附件口中,
将一个定位件固定到心房附件壁上,使定位件与一个位于定位件和隔膜之间的系绳相连接,使隔膜抵住心房附件口,
将定位索从系绳系到隔膜的对中定位凸缘上,使隔膜对中定位在心房附件口上。
33.根据权利要求27所述的防止心房附件血栓进入血流的方法,其特征在于,使隔膜对中定位在附件口上的对中定位装置包括:
将一个定位件固定到心房附件壁上,使定位件与一个位于定位件和隔膜之间的系绳相连接,使隔膜抵住心房附件口,
将定位索从系绳系到隔膜上,使隔膜对中定位在心房附件口上。
34.根据权利要求27所述的防止心房附件血栓进入血流的方法,其特征在于,使隔膜对中定位在附件口上的对中定位装置包括:
将一个对中定位凸缘固定在隔膜上,用于插入到心房附件口中,
将一个定位件固定到心房附件壁上,使定位件与一个位于定位件和隔膜之间的系绳相连接,使隔膜抵住心房附件口,
将定位索从系绳系到隔膜上,使隔膜对中定位在心房附件口上。
35.根据权利要求1所述的防止心房附件血栓进入血流的方法,其特征在于,它还包括:将标示件固定在隔膜上,用于在隔膜置于心房附件口上时观察隔膜的位置。
36.根据权利要求1所述的防止心房附件血栓进入血流的方法,其特征在于,它还包括:将传感器固定在隔膜上,用于提供关于患者的信息。
37.一种阻挡一个心房附件口的隔膜,它包括:
一个隔膜,
一个用隔膜阻挡心房附件口的装置,使血液不进入心房附件形成血栓,并且使血栓不离开心房附件。
38.根据权利要求37所述的阻挡一个心房附件口的隔膜,其特征在于,阻挡心房附件口的装置包括一个置于附件口上的隔膜,隔膜具有插脚,这些插脚延伸穿过附件口,紧靠在心房附件壁上,使隔膜牢牢固定在附件口上。
39.根据权利要求38所述的阻挡一个心房附件口的隔膜,其特征在于,记忆合金插脚用于在心房附件之内膨胀到所需形状,使隔膜牢牢固定在附件口上。
40.根据权利要求37所述的阻挡一个心房附件口的隔膜,其特征在于,布置在每个插脚端头上的一个球形件防止插脚刺穿心房附件壁而形成栓塞。
41.根据权利要求37所述的阻挡一个心房附件口的隔膜,其特征在于,插脚刺穿心房附件壁,使隔膜固定就位。
42.根据权利要求37所述的阻挡一个心房附件口的隔膜,其特征在于,插脚呈一个圆固定在隔膜上,这样,插脚就会使隔膜对中定位在附件口上。
43.根据权利要求37所述的阻挡一个心房附件口的隔膜,其特征在于,隔膜和插脚之间的一个移植片固定物嵌入在心房附件口的口径中,使隔膜在附件口上牢固地固定就位。
44.根据权利要求43所述的阻挡一个心房附件口的隔膜,其特征在于,插脚刺穿心房附件壁,使隔膜固定就位。
45.根据权利要求37所述的阻挡一个心房附件口的隔膜,其特征在于,阻挡附件口的装置包括移植片固定物插脚,固定物的这些插脚固定在隔膜上,并且穿过心房附件口延伸到心房附件内。
46.根据权利要求45所述的阻挡一个心房附件口的隔膜,其特征在于,记忆合金的移植片固定物插脚用于在心房附件之内膨胀到所需形状,使隔膜牢牢固定在附件口上。
47.根据权利要求37所述的阻挡一个心房附件口的隔膜,其特征在于,阻挡附件口的装置包括一个进入或穿过心房附件壁的锚固件以及一根连接锚固件和隔膜的系绳,使隔膜牢固地固定在心房附件口上。
48.根据权利要求47所述的阻挡一个心房附件口的隔膜,其特征在于,系绳是弹性的,用于牵拉隔膜使之紧靠在心房附件口上。
49.根据权利要求37所述的阻挡一个心房附件口的隔膜,其特征在于,阻挡附件口的装置包括一个进入或穿过心房附件壁的锚固件以及一根连接锚固件和隔膜的弹簧,使隔膜牢固地固定在心房附件口上。
50.根据权利要求37所述的阻挡一个心房附件口的隔膜,其特征在于,阻挡附件口的装置包括一个填充心房附件并与隔膜相连接的螺旋弹簧,使隔膜牢固地固定在心房附件口上。
51.根据权利要求37所述的阻挡一个心房附件口的隔膜,其特征在于,阻挡附件口的装置在隔膜上具有一种粘合剂,使隔膜固定在心房附件口上。
52.根据权利要求37所述的阻挡一个心房附件口的隔膜,其特征在于,一个真空装置采用吸出术从心房附件去除血栓并缩小心房附件的空间。
53.根据权利要求37所述的阻挡一个心房附件口的隔膜,其特征在于,阻挡附件口的装置包括一个布置在心房附件壁相反侧面上的盘形件以及一个连接盘形件和隔膜的弹簧,使隔膜牢固地固定在心房附件口上。
54.根据权利要求37所述的阻挡一个心房附件口的隔膜,其特征在于,阻挡附件口的装置包括一个布置在心房附件壁相反侧面上的盘形件以及一个连接盘形件和隔膜的系绳,使隔膜牢固地固定在心房附件口上。
55.根据权利要求37所述的阻挡一个心房附件口的隔膜,其特征在于,阻挡附件口的装置包括一种填充心房附件的隔膜材料。
56.根据权利要求37所述的阻挡一个心房附件口的隔膜,其特征在于,阻挡附件口的装置包括一个伞柱,在伞柱的一端具有伞撑,
一个伞撑打开机构用于使伞撑从伞撑靠近伞柱的闭合位置展开到伞撑从伞柱径向张开的打开位置,这样,伞撑可以在闭合位置通过一个心房附件口插入,然后打开,使伞撑与心房附件壁接合,而不能从附件口抽出,
伞柱具有齿,
隔膜中的一个棘爪用于形成一个与齿相配合的棘轮机构,使隔膜沿伞柱的长度移动进入锁定位置,确保隔膜固定在与伞撑相对的心房附件口上。
57.根据权利要求37所述的阻挡一个心房附件口的隔膜,其特征在于,阻挡附件口的装置包括一个用于插入到附件口中的可折叠移植片固定物,固定物膨胀并与附件口的周边相接合,将一个可折叠隔膜固定在固定物的管腔上,这样,打开固定物,使隔膜展开在固定物的管腔上,从而阻挡附件口。
58.根据权利要求37所述的阻挡一个心房附件口的隔膜,其特征在于,隔膜上的一种防血凝药物防止血栓形成。
59.根据权利要求37所述的阻挡一个心房附件口的隔膜,其特征在于,一种注入心房附件中的化学烧蚀剂烧蚀心肌组织,从而防止心房纤维性颤动的电传播。
60.根据权利要求37所述的阻挡一个心房附件口的隔膜,其特征在于,隔膜是一个促使内皮细胞在隔膜的孔中生长的气孔隔膜,因此在隔膜上形成一个防止血栓形成的细胞壁。
61.根据权利要求37所述的阻挡一个心房附件口的隔膜,其特征在于,隔膜是一个促使内皮细胞在隔膜的孔中生长的金属网,因此在隔膜上形成一个防止血栓形成的细胞壁。
62.根据权利要求37所述的阻挡一个心房附件口的隔膜,其特征在于,一种物质注入心房附件中,使隔膜密封以防漏出。
63.根据权利要求37所述的阻挡一个心房附件口的隔膜,其特征在于,一种物质注入心房附件中,填充心房附件并缩小其空间。
64.根据权利要求37所述的阻挡一个心房附件口的隔膜,其特征在于,一种血凝剂注入心房附件中,使血液在其中凝结,使之不能流出心房附件。
65.根据权利要求37所述的阻挡一个心房附件口的隔膜,其特征在于,隔膜具有一个使隔膜对中定位在心房附件口上的装置。
66.根据权利要求65所述的阻挡一个心房附件口的隔膜,其特征在于,使隔膜对中定位在心房附件口上的装置包括:一个位于隔膜上、用于布置在附件口中的对中定位凸缘。
67.根据权利要求65所述的阻挡一个心房附件口的隔膜,其特征在于,使隔膜对中定位在心房附件口上的装置包括:
一个用于使一个弹簧固定到心房附件的一个壁上并且使弹簧的另一端固定在隔膜上的装置,
系在弹簧上并与隔膜相连接的、用于使隔膜对中定位在附件口上的定位索。
68.根据权利要求65所述的阻挡一个心房附件口的隔膜,其特征在于,
一个位于隔膜上、用于布置在附件口中的对中定位凸缘,
一个用于使一个弹簧固定到心房附件的一个壁上并且使弹簧的另一端固定在隔膜上的装置,
系在弹簧上并与隔膜相连接的、用于使隔膜对中定位在附件口上的定位索。
69.根据权利要求65所述的阻挡一个心房附件口的隔膜,其特征在于,
一个位于隔膜上、用于布置在附件口中的对中定位凸缘,
一个用于使一个弹簧固定到心房附件的一个壁上并且使弹簧的另一端固定在隔膜上的装置,
系在弹簧上并与隔膜的对中定位凸缘相连接的、用于使隔膜对中定位在附件口上的定位索。
70.根据权利要求65所述的阻挡一个心房附件口的隔膜,其特征在于,使隔膜对中定位在心房附件口上的装置包括:
一个用于使一根系绳固定到心房附件的一个壁上并且使系绳的另一端固定在隔膜上的装置,
系在系绳上并与隔膜相连接的、用于使隔膜对中定位在附件口上的定位索。
71.根据权利要求65所述的阻挡一个心房附件口的隔膜,其特征在于,
一个位于隔膜上、用于布置在附件口中的对中定位凸缘,
一个用于使一个系绳固定到心房附件的一个壁上并且使系绳的另一端固定在隔膜上的装置,
系在系绳上并与隔膜相连接的、用于使隔膜对中定位在附件口上的定位索。
72.根据权利要求65所述的阻挡一个心房附件口的隔膜,其特征在于,
一个位于隔膜上、用于布置在附件口中的对中定位凸缘,
一个用于使一个系绳固定到心房附件的一个壁上并且使系绳的另一端固定在隔膜上的装置,
系在系绳上并与隔膜的对中定位凸缘相连接的、用于使隔膜对中定位在附件口上的定位索。
73.根据权利要求65所述的阻挡一个心房附件口的隔膜,其特征在于,使隔膜对中定位在心房附件口上的装置包括:固定在隔膜上的标示件,用于在隔膜置于心房附件口上时观察隔膜的位置。
74.根据权利要求37所述的阻挡一个心房附件口的隔膜,其特征在于,至少一个传感器固定在隔膜上,用于对患者进行监测。
75.一种阻塞患者体内孔口的方法,它包括:
用导管无损害地将隔膜插入孔口中以阻挡孔口,
使隔膜紧靠孔口,用一个装置将隔膜固定在孔口对面的体组织上,从而将隔膜固定就位。
76.根据权利要求75所述的阻塞患者体内孔口的方法,其特征在于,它还包括将隔膜固定在一个假动脉瘤上。
77.根据权利要求75所述的阻塞患者体内孔口的方法,其特征在于,它还包括将隔膜固定在一个瘘上。
78.根据权利要求75所述的阻塞患者体内孔口的方法,其特征在于,它还包括将隔膜固定在一个心房附件口上。
79.一种阻塞患者体内孔口的隔膜,它包括:
一个隔膜,
通过将隔膜置于孔口一侧而使隔膜固定在孔口上的装置,和使一个连接件在孔口的相对一侧固定到体组织上的装置。
80.根据权利要求79所述的阻塞患者体内孔口的隔膜,其特征在于,隔膜覆盖一个假动脉瘤。
81.根据权利要求79所述的阻塞患者体内孔口的隔膜,其特征在于,隔膜覆盖一个瘘。
82.根据权利要求79所述的阻塞患者体内孔口的隔膜,其特征在于,隔膜覆盖一个心房附件口。
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- 2000-10-23 IL IL14930000A patent/IL149300A0/xx unknown
- 2000-10-23 CN CN00816176A patent/CN1399531A/zh active Pending
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Also Published As
Publication number | Publication date |
---|---|
ATE288231T1 (de) | 2005-02-15 |
US20030120337A1 (en) | 2003-06-26 |
WO2001030268A1 (en) | 2001-05-03 |
JP2003512129A (ja) | 2003-04-02 |
ES2232516T3 (es) | 2005-06-01 |
US20120283773A1 (en) | 2012-11-08 |
US6551303B1 (en) | 2003-04-22 |
US20050049573A1 (en) | 2005-03-03 |
US8221445B2 (en) | 2012-07-17 |
IL149300A0 (en) | 2002-11-10 |
US6949113B2 (en) | 2005-09-27 |
CA2388603A1 (en) | 2001-05-03 |
EP1225843A1 (en) | 2002-07-31 |
AU779124B2 (en) | 2005-01-06 |
AU2299001A (en) | 2001-05-08 |
DE60017928D1 (de) | 2005-03-10 |
EP1579823A2 (en) | 2005-09-28 |
US20030191526A1 (en) | 2003-10-09 |
DE60017928T2 (de) | 2005-06-23 |
EP1225843B1 (en) | 2005-02-02 |
US6730108B2 (en) | 2004-05-04 |
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