CN1878581B - 用于心脏辅助装置的致动器 - Google Patents
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Abstract
一种用于心脏辅助装置的致动器(10)。所述致动器(10)包括可充气的气球(12)和覆盖物或包裹物(14)。可充气的气球(12)具有第一主体部分(22),第二主体部分(26)和连接第一主体部分(22)和第二主体部分(26)的挠性区域(24)。邻接第一主体部分(24)设置并且具有外围延伸的覆盖物或包裹物(14)。所述外围延伸至少等于气球挠性区域(24)的外围延伸。所述气球(12)和所述覆盖物或包裹物(14)被成形为使得覆盖物或包裹物(14)针对朝向所述覆盖物或包裹物超过预定的限度的位移,在挠性区域(24)处或附近限制气球第一主体部分(22)的一部分,但是允许不限制远离所述覆盖物或包裹物的位移。
Description
技术领域
本发明一般涉及心脏辅助装置、系统和方法,并且更特别地涉及用于一种用于反博心脏辅助装置的致动器。
背景技术
美国专利No.4630597和国际PCT专利申请No.PCT/US00/22992(WO01/13974)都公开了利用可膨胀气球的心脏辅助装置,该气球定位于患者的动脉血管中。所述气球代替血管的切除部分并且可以被循环膨胀和收缩从而扩张进入血管并且因此在心脏舒张过程中辅助血液移动以及在心脏收缩过程中从血管中收回。
上述两个文件都公开了具有包括了入口/出口的相对硬质外壳的装置,所述出口/入口连接到流体泵。所述挠性气球围绕外壳的外围密封并且向后延伸在所述外壳外部的部分或全部之上。另一层材料随后设置在所述气球外表之上,邻近所述外壳,从而将气球紧固于外壳。
申请人的国际PCT专利申请No.PCT/AU00/00654,PCT/AU01/01187以及PCT/AU02/00974都公开某种致动器,发现该致动器都因在与大动脉连接的气球中的疲劳而产生了失效。
本发明的目的在于提供一种经过改进的致动器。
发明内容
因此,在第一方面,本发明提供一种用于心脏辅助装置的致动器,所述致动器包括:
具有第一主体部分、第二主体部分的可膨胀气球以及连接第一和第二主体部分的挠性区域;以及
邻接第一主体部分并且具有至少等于所述气球挠性区域外围延伸的外围延伸的覆盖物或包裹物;
其中所述气球和覆盖物或包裹物被成形为使得所述覆盖物或包裹物针对朝向覆盖物或包裹物的超过预定限度的移动(向外位移),在挠性区域处或附近限制气球第一主体部分的一部分,但是允许远离覆盖物或包裹物的不受限移动(向内位移)。
所述气球和覆盖物优选地成形为使得所述覆盖物,在气球膨胀过程中在挠性区域处或附近限制气球第一主体部分的所述部分向外位移,但是在收缩过程中允许不受限的向内位移。
优选地,在向内位移过程中,气球第二主体部分的内表面的至少一部分可以被拉回紧靠气球第一主体部分的内表面的至少一部分。
所述覆盖物优选地通常向内凹入,最优选地呈细长和椭圆形。
第一主体部分,第二主体部分以及挠性区域优选地是整体形成的,最优选地是通过浸渍模塑形成的。
所述致动器优选地还包括适于连接到动力源的套管。
所述气球优选地还包括连接到第一部分的颈部,所述颈部适于与所述套管的密封连接。
所述覆盖物还优选地包括适于与气球颈部密封连接的颈部。
在第二方面,本发明提供一种用于心脏辅助装置的致动器,所述致动器包括:
适于连接到液压或气动动力源的套管;以及
具有适于与所述套管外部密封连接的较窄颈部、较宽的第一和第二主体部分以及连接第一和第二主体部分的弧形的挠性区域的可膨胀气球,第一主体部分具有邻近颈部的第一端以及邻近第二主体部分的第二端并且通常向内凹,当气球膨胀时第二主体部分向内凹而在气球收缩时其通常会向外凹。
所述装置优选地还包括具有外围延伸的主体部分的覆盖物或包裹物,该外围延伸至少等于或气球第一和第二主体部分的外围延伸。
所述气球和覆盖物或包裹物优选地成形为使得由覆盖物或包裹物针对超过预定限度的向外位移,在挠性区域或附近对气球第一主体的一部分进行限制,但是不限制向内位移。
优选地,在向内位移过程中,所述气球第二主体部分的至少部分内表面可以被拉回直接地抵靠气球第一主体部分的至少一部分内表面。
在第三方向,本发明提供一种心脏辅助装置,包括:
液压或气动动力源;以及
一种致动器,其包括:
适于操作连接到动力源的套管;
具有适于密封连接套管外表的较窄颈部、较宽第一和第二主体部分以及连接第一和第二主体部分的挠性区域的可膨胀气球,第一主体部分具有邻近颈部的第一端以及邻近第二主体部分的第二端并且通常向内凹,当气球膨胀时第二主体部分通常向内凹,而在气球收缩时其通常会向外凹;以及
具有外围延伸的主体部分的覆盖物或包裹物,所述外围延伸至少等于气球第一和第二主体部分的外围延伸,
其中气球和覆盖物成形为使得在挠性区域或附近由覆盖物针对超过预定限制的向外位移限制气球第一主体部分的一部分,但是不限制向内位移。
优选地,在向内位移过程中,气球第二主体部分的至少一部分内表面可以被拉回抵靠着气球第一主体部分的内表面的至少一部分。
优选地,气球和覆盖物成形为使得基本上所有的气球第一主体部分受到覆盖物针对向外位移的限制,并且不限制向内位移。
在其优选形式中,心脏辅助装置被配置成用于外动脉反博装置。在这种形式中,气球被定位在动脉血管的外部。
在另外一种形式中,心脏辅助装置被配置用作搭桥或动脉补片,在搭桥中所述装置代替动脉的完全被切除部分,在动脉补片中孔形成在动脉中,所述装置填充在动脉中。
当气球膨胀时,挠性区域优选地具有至少0.1mm的曲率半径,更优选地是具有大约1.0mm的曲率半径,并且最优选地具有大约3.0mm的曲率半径。
气球颈部与气球挠性区域的直径比率优选的是不超过大约4∶1,而且更优选的大约为3∶1并且更优选的是大约2∶1。
所述套管优选地具有入口/出口孔。所述孔优选地还包括一个或多个适于防止气球被吸入所述孔的内部限制部分。
所述气球优选地由硅树脂、聚氨酯或聚氨酯-聚硅氧烷块嵌段共聚合物形成。所述气球优选地通过轴浸形成。所述气球优选地通过将适合形状的心轴浸入聚合物并且允许聚合物薄涂层固化在所述心轴上而形成。所述气球优选地有2至4层涂层,总厚度为150-300微米。所述气球随后可以从所述心轴移走。
气球颈部优选地紧密地密封配合在套管外部上。覆盖物或包裹物优选地具有颈部,其紧密地密封配合在所述气球颈部上。
所述套管优选地具有适于和气球颈部配合的稍稍呈锥度的颈部。所述套管颈部优选地具有在气球方向上收敛的锥度。
所述气球优选地在动脉上由挠性包裹物被保持到位,所述挠性包裹物围绕所述大动脉延伸并且支撑抵靠气球的第一主体部分或安装在其上的覆盖物。所述挠性包裹物优选地成形为配合气球的第二主体部分,并且如果希望的话也配合所述颈部。所述挠性包裹物优选地是非弹性的或稍稍具有弹性,从而使得它的延伸和挠性特性基本上与原来的动脉匹配。
在第四方面,本发明提供一种用于血液移动心脏辅助装置的挠性可膨胀气球,所述气球被整体地形成为单一件并包括:
具有第一和第二端的颈部;基本上环形的第一主体部分,其在内部外围连接到颈部第二端;以及基本上椭圆形或圆形的第二主体部分,
环形内凹的挠性部分,其将第一和第二主体部分的外部外围连接到一起,并且当第二主体部分在当气球收缩且第二主体部分的内表面抵靠到气球的第一主体部分内表面的至少一部分时的凹入形状和当气球膨胀时的凸出形状之间运动时,该环形内凹的挠性部分适于在第二主体部分的运动过程中保持曲率半径。
所述气球优选地形成为单独一件。这避免了如在美国专利说明书4630597或国际专利说明书WO 01/13974中所公开的接合线。本发明人已经发现这种接合线会提高气球中的应力等级并且减少气球的运行寿命。
可在气球的环形第一主体部分附近和其上设置覆盖物。所述覆盖物优选地成形,从而使得在气球膨胀过程中,所述覆盖物针对向外位移,在所述挠性区域处或附近限制气球的所述部分,但是在收缩过程中允许不受限的向内位移。所述覆盖物优选地通常内凹,最优选地呈细长并且呈椭圆形。所述覆盖物优选地还包括适于与气球颈部密封连接的颈部。所述覆盖物可以用来将包裹物粘接于气球的第一主体部分。
所述气球优选地还包括适于连接到液压或气动动力源的套管。所述套管还用来防止在收缩过程中气球颈部的向内凹塌陷。如果希望的话,所述套管可以形成有诸如凹槽、肋或第二内腔的内部限制物,从而在气球收缩过程中防止气球被吸入套管。所述气球的颈部优选地适用于与套管的密封连接。所述套管优选地具有使气球颈部的相对较大直径适配于将气球连接到动力源的液压或气动流体管线的相对较小的直径的锥度。这个锥度优选地是细长的,从而沿中心轴线增强所述套管的挠性。
在第五方面,本发明提供一种用于心脏辅助装置的致动器,所述致动器包括:
挠性可膨胀的气球,其具有在一端连接到球状的主体部分的颈部,所述球状的主体部分具有第一侧和第二侧;以及
基本上非弹性的覆盖物或包裹物,其具有延伸在气球球状的部分的邻接第一侧之上的向外伸展部分,
其中,在收缩过程中,球状的主体部分的第二侧可以被缩回抵靠所述球状的主体部分的第一侧。
所述覆盖物或包裹物优选地支持气球球状的部分的第一侧抵抗在气球球状的部分的第二侧于膨胀和收缩过程中自由移动时的显著移动。
在第六方面,本发明提供一种方法,该方法提供了使用根据第一或第二或第五方面的致动器的外动脉心脏辅助,或者根据第三方面的心脏辅助装置或第四方面的气球,所述方法包括邻接动脉血管的外部安装气球第二主体部分。
在第七方面,本发明提供一种方法,该方法提供了使用根据第一或第二或第五方面的致动器的内动脉心脏辅助,或者根据第三方面的心脏辅助装置,所述方法包括切除部分的动脉血管并且安装带有密封替换所述被切除部分的气球第二主体部分的气球。
附图说明
通过结合附图以示例的方法对本发明的优选实施例进行说明,其中:
图1是根据本发明的致动器的第一实施例的分解透视图;
图2是图1所示致动器的组装、局部剖面的透视图;
图3是图1所示致动器的沿线3-3的组装、剖面图;
图4是图1所示致动器的沿线4-4的组装、剖面图;
图5是根据本发明的致动器的第二实施例的沿线5-5的剖视图;
图6是用于图5所示致动器的套管的仰视图;
图7是用于根据本发明的致动器的第三实施例的气球的剖面透视图;
图8是图7所示气球的俯视图;
图9是根据本发明的致动器的第四实施例的剖面侧视图;
图10是图9所示致动器的透视图;以及
图11是图9所示致动器的正视图。
具体实施方式
图1示出根据本发明第一实施例的致动器10的分解透视图,其大小用于儿科用途。所述致动器10具有挠性、可膨胀气球12,非弹性的覆盖物14,以及相对硬制的套管16。
气球12是由聚氨酯或类似的生物适应性和生物稳定性材料通过轴浸形成的。气球12具有较窄的颈部18,该颈部通过向外展开的部分20连接到较宽的第一主体部分22。大致围绕气球12的外部延伸的挠性区域24在其最宽部分将第二主体部分26(见图2至4)连接到第一主体部分22。
当在平面图中观察时,第一和第二主体部分在形状上大致呈椭圆形并且分别具有用于成人尺寸气球的大约20-35mm的最大宽度和大约50-90mm的最大长度。所述气球12的气球颈部在其远端18a具有大约10-14mm的直径,在其近端18b呈椭圆形,具有大约30-50mm的长轴和15-30mm的短轴,在远端和近端之间具有收敛的锥度。儿科用气球也被考虑用于相同的用途,但是在尺寸上适当地减小。
所述覆盖物14是由基本上等同于用于所述气球的材料,诸如聚氨酯或聚氨酯-聚硅氧烷嵌段共聚合物通过轴浸形成的。所述覆盖物14具有较窄的颈部28,其由向外展开的部分32连接到较宽的主体部分30。所述覆盖物主体部分30从平面图进行观察时在形状上也呈大致的椭圆形并且具有大于气球主体部分22和26以及挠性区域24的外部延伸(即在所有方向上的进一步延伸)。更特别地,所述覆盖物主体部分30具有60-100mm的长度(气球12的长轴)以及20mm的最小宽度(横跨气球12的短轴)。所述覆盖物颈部28的大小可以紧密地密封配合在气球颈部18的外部上。
所述套管16是由诸如聚氨酯或类似材料的挠性塑料通过注射成型而形成的。所述套管16具有中空孔36,其适于与来自于诸如流体泵(未示出)的动力源的流体管线密封连接。适合的泵被公开在申请人的国际PCT专利申请No.PCT/AU02/00974中,题目为“流体压力发生装置”,该申请的全部内容结合于此进行参考。所述套管16还具有相对较多锥度的远端部分38和相对较少锥度的近端部分40。所述近端部分40的大小可以紧密地密封配合在气球颈部18的内部。
图2示出组装之后的装置10。所述组件包括最初伸展的气球12的颈部18,从而使得套管16的近端部分40可以插入其中。气球12由覆盖物14限制成紧邻套管16,所述覆盖物14受迫穿过套管16的远端部分38直至其如图所示紧密地密封配合在气球颈部18的外部之上。所述套管的近端部分40,气球颈部18,以及覆盖物颈部28都具有相同的锥形角度。所述部件也通过适当的粘合剂粘合在一起从而确保它们之间的有效密封。
将会参考图3和图4对所述装置10的操作进行说明。图3是沿大动脉纵向的剖视图(正视图)。图4是从图3所示转过90度的局部剖视图。
对于外大动脉心脏辅助,装置10设置有紧邻动脉血管外部的气球第二部分26,最优选的是紧邻上升动脉(未示出)的外部。挠性的、相对没有弹性的包裹物被设置在覆盖物30之上并且围绕所述动脉从而将装置10保持到位。在现有技术中包裹物是公知的并且因此不做进一步详细的说明。所述包裹物也可以被用来代替所述覆盖物。
在使用中,流体经由套管孔36到气球12以及从气球12被循环驱动,从而循环膨胀和收缩气球12。所述膨胀气球12以实线示出在图3中。所述膨胀气球12压缩动脉并且因此在心脏舒张期间辅助血液移动。当气球12被收缩时,其回到由虚线所示的位置,这就允许在心脏收缩期间动脉回到它的自然形状。
正如图3和图4所示,当气球12膨胀时,覆盖物14针对超过预定限度的向外位移,限制气球的第一部分22直至并且包括紧邻挠性区域24的部分。该限度是由覆盖物主体部分30的形状限定的。但是,在收缩过程中,覆盖物14不限制气球第一部分22的向内位移,特别是处于或靠近挠性区域24的部分。这就允许气球12总是保持邻接挠性区域24的相对较大的曲率半径(即1.0mm),所述挠性区域是气球12经受最大的变形的部分。这有效地减小了集中在挠性区域24中的应力和应变,导致了更可靠和更长寿命的气球18。
这一点不同于先前提及的两篇对比文件中示出的气球,在这两篇对比文件中,气球在等同于所述挠性区域的区域上在向外和向内的位移上受到限制。这些气球在它们的自由边缘经历了类似于枢转或弯曲的运动。这导致了在那些气球中的较高程度的应力集中,以及伴随较高的失效风险。
此外,在等同于两年没有任何失效的循环之后,用于和羊一起使用的(并且相应于上述致动器10)一组致动器的循环测试终止了。另外,用于和人一起使用的类似的致动器的循环测试已经获得了等同于18个月没有任何失效的结果。
所述致动器10也是简单的,并且因此相对于现有技术的装置,其组装和制造便宜,这是因为套管16仅与气球12在它们相应的颈部40,18的区域中配合,不同于将所述套管(或壳体)更完全地定位在气球的主体部分中。
还应注意到的是,致动器10被设计成应用于血管的外侧,并且因此与在背景技术中所讨论的定位在血管壁内的现有技术的装置相比其优势是非血液接触的。
还应注意到的是,气球的向内凹度(收缩时)被特别设计成配合于弓形的上升动脉,以允许围绕上升动脉的组装好致动器的适度包裹。通过气球膨胀,动脉壁以“拇指按压”方式位移,这已经通过有限元分析示出,从而在动脉壁中导致最小的应力集中,并且还提供了最大的血液体积位移。
在更优选的实施中,气球在其纵向平面中具有半径等级为150-300mm的舒缓弧形,从而容纳上升动脉的轻微螺旋的特性,以允许组装好装置的更为适度的配合。
图5和图6示出根据本发明的致动器50的第二实施例。装置50类似于第一实施例,并且相同的附图标记被用于指示相同的特征。
两个实施例之间的主要区别在于,装置50中的套管16包括一系列的内部突起52,它们用于在大量的吸气/放气过程中阻止气球18被吸入套管的孔36中。这种大量的吸气/放气可能发生在适合与血液移动装置50一起使用的某些泵的校准循环过程中。
图7和图8示出用于根据本发明的致动器的第三实施例的气球60。所述气球60的大小适用于成人,除此之外类似于第一实施例,相同的附图标记被用于指示相同的特征。当在平面图中观察时,第一和第二主体部分24和26在形状上大致呈椭圆形,并且分别具有35mm的最大宽度和80mm的最大长度。所述气球颈部在其远端18a具有大约10mm的直径以及在其近端18b(在剖面上呈椭圆形)具有大约26-44mm的直径,并且在远端和近端之间具有锥形收敛的锥度。
图8至图10示出根据本发明的致动器70的第四实施例。相同的附图标记被用于指示与前述实施例相同的特征。致动器70使用示出在图7和8中的气球60。致动器70的套管16与先前实施例的不同之处在于其基本上是中空的,带有在一端连接到外部伸展锥形部分16b的中心圆柱形部分16a。一系列径向板16c设置在中心圆柱形部分16a和伸展锥形部分16b之间。挠性的、相对非弹性的包裹物72设置在气球60上,该气球具有套管16穿过的开口72a。
本领域技术人员应该认识到,在不背离广泛限定的本发明的精神和范围的前提下,可以对示出在特定实施例中的本发明进行各种变化和/或修改。例如,虽然已经在上面结合外动脉反博装置对所述血液移动装置进行了说明,但其也适用于内动脉反博装置。在后者中,气球的第二部分代替了动脉血管的切除部分,形成在被切除的动脉血管中的开口被密封连接到紧邻挠性区域的气球。
Claims (7)
1.一种用于血液移动心脏辅助装置的挠性可膨胀气球,所述气球被整体地形成为单一件并包括:
具有第一和第二端的颈部;
基本上环形的第一主体部分,其在内部外围连接到颈部第二端;以及
基本上椭圆形或圆形的第二主体部分,
环形内凹的挠性部分,其将第一和第二主体部分的外部外围连接到一起,并且当第二主体部分在当气球收缩且第二主体部分的内表面抵靠到气球的第一主体部分内表面的至少一部分时的凹入形状和当气球膨胀时的凸出形状之间运动时,该环形内凹的挠性部分适于在第二主体部分的运动过程中保持曲率半径。
2.根据权利要求1所述的挠性可膨胀气球,还包括覆盖物,其被定位为抵靠所述第一主体部分的外表面,从而在气球收缩时限制第一主体部分远离第二主体部分的位移。
3.根据权利要求2所述的挠性可膨胀气球,其中所述覆盖物向内凹。
4.根据权利要求2或3所述的挠性可膨胀气球,其中所述气球在动脉上由挠性包裹物保持到位,所述挠性包裹物围绕所述动脉延伸并且支撑抵靠所述气球的第一主体部分或所述覆盖物。
5.根据权利要求1所述的挠性可膨胀气球,其中所述气球通过浸渍模塑形成。
6.根据权利要求1所述的挠性可膨胀气球,还包括适于连接到液压或气动动力源的套管。
7.根据权利要求6所述的挠性可膨胀气球,其中所述颈部适于与套管密封连接。
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- 2004-10-28 AU AU2004286722A patent/AU2004286722B2/en not_active Ceased
- 2004-10-28 EP EP04789625A patent/EP1682200A4/en not_active Withdrawn
- 2004-10-28 US US10/595,605 patent/US7955248B2/en not_active Expired - Fee Related
- 2004-10-28 CN CN200480033211XA patent/CN1878581B/zh not_active Expired - Fee Related
- 2004-10-28 JP JP2006538594A patent/JP5063112B2/ja not_active Expired - Fee Related
- 2004-10-28 WO PCT/AU2004/001487 patent/WO2005044338A1/en active Application Filing
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2011
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2012
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Also Published As
Publication number | Publication date |
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JP2012130725A (ja) | 2012-07-12 |
JP2007510474A (ja) | 2007-04-26 |
WO2005044338A1 (en) | 2005-05-19 |
EP1682200A4 (en) | 2009-12-16 |
EP1682200A1 (en) | 2006-07-26 |
US20110288367A1 (en) | 2011-11-24 |
AU2004286722A1 (en) | 2005-05-19 |
AU2004286722B2 (en) | 2011-03-03 |
US7955248B2 (en) | 2011-06-07 |
US8702583B2 (en) | 2014-04-22 |
JP5274682B2 (ja) | 2013-08-28 |
CN1878581A (zh) | 2006-12-13 |
JP5063112B2 (ja) | 2012-10-31 |
EP2574352A1 (en) | 2013-04-03 |
WO2005044338A8 (en) | 2005-07-28 |
US20070129796A1 (en) | 2007-06-07 |
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