CN104394785B - 可转向的腔内穿孔器 - Google Patents
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Abstract
本发明涉及一种可转向的经中隔穿孔器。
Description
技术领域
本发明涉及经中隔穿孔器。
背景技术
左心房中的缺陷是常见的,并且引起了多种疾病,包括心房纤颤、二尖瓣脱垂和心耳血栓。所述缺陷可以通过利用插入心房的导管的侵入方法微创地治疗。必须利用穿过腔静脉并穿过卵圆窝操纵的导管使左心房接近右心房,该卵圆窝是左心房与右心房之间的薄壁。必须刺穿卵圆窝以允许提供导管进入左心房的通道。为了刺穿卵圆窝,外科医生使用一种经中隔穿孔器,该经中隔穿孔器也被称为布罗肯布鲁格(Brockenbrough)针。布罗肯布鲁格针是一种在其端部弯曲的很长的、非常细的穿孔器。该弯曲是重要的,因为其便于穿孔器的操作。
在其中经中隔地穿过右心房获得通向左心房的通路的一般方法中,外科医生将马林斯(Mullins)导引导管传送到右心房中,并且然后穿过马林斯导引导管将经中隔穿孔器传送到右心房中。利用设置在穿孔器内的管心针通过导引导管来操纵经中隔穿孔器(和通常的整体式充填器或者扩张器)。在此刻,经中隔穿孔器的远侧末端设置在导引导管的远端内。在确认穿孔器被正确地定位和定向之后,外科医生然后完全撤回管心针并且将马林斯导引导管撤回一短距离以露出经中隔针的末端,并且然后推动经中隔穿孔器穿过卵圆窝。在经中隔穿孔器已经刺穿卵圆窝并且进入左心房之后,外科医生在穿孔器上推动马林斯导引导管以使马林斯导引导管的远侧末端驻留在左心房中。外科医生然后从马林斯导引导管中完全移除穿孔器。在将马林斯导引导管的末端设置在左心房内之后,外科医生可以通过马林斯导引导管将任何期望的导管或者装置传送到左心房中。
将弯曲的经中隔穿孔器推过大致直的马林斯导引导管。这可能导致从马林斯导管内侧削掉或者切掉小塑料碎片。从导管刮下的任何塑料碎片可能沉积在右心房或者左心房中,并随后对患者引起伤害。
发明内容
如下所述的装置和方法为可转向布罗肯布鲁格针或者经中隔穿孔器提供了一种坚固的转向机构。经中隔穿孔器包括一个设置在另一个内的两个管。内管伸出外管的远侧末端外一短距离以提供穿孔器的穿刺末端。外管在其远端处具有增大柔性的部位,该部位形成了可偏转或者“可转向”段。内管仅在该可偏转段远侧的点处固定到外管上。内管在与可偏转段对应的部位中被纵向地延伸的槽分开。可以相对于外管向近侧拉拔内管(或者相对于内管推动外管)来迫使所述可偏转段弯曲。在内管中纵向地定向的槽提供了偏转所需的柔性,而同时防止外管塌缩。固定至内管和外管两者的近侧套节(hub)可操作来相对于外管向远侧拉拔内管(或者相对于内管推动外管)。所述可转向经中隔穿孔器的使用避免了现有技术的经中隔穿孔器的刮削问题。
附图说明
图1图解了经中隔穿孔器的侧视图,其组装成内管被沿与外管相反180度的方向弯曲,结果形成了基本上直的穿孔器结构。
图2图解了包括接近远端以形成增大柔性部位的多个槽的铰接式经中隔穿孔器的外管的部分分离的侧视图。
图3图解了包括将管分成两个轴向定向部分的纵向槽的铰接式经中隔穿孔器的内管的部分分离的侧视图,所述轴向定向部分在内管的远端处相连。
图4图解了包括同心地设置并周向地定向的外管和内管的铰接式经中隔穿孔器的远端的部分分离图。
图5图解了包括剖开式内管和T形槽外管的铰接式经中隔穿孔器的远端的侧视图,具有相对于外管向近侧拉拔的内管以促使外管变形成具有非常硬或者刚性的机械性能的弯曲件。
图6图解了几乎前进至充填器或者扩张器远端的铰接式隔膜穿孔器的远端,所述充填器或者扩张器同轴地、可移除地组装到导引导管护套的中央管腔中。
图7图解了还包括具有可塌缩远侧护套的可移除充填器的铰接式经中隔穿孔器的远端。
图8图解了包括旋塞和弯曲调整机构的铰接式经中隔穿孔器的近端的截面图。
图9图解了铰接式经中隔穿孔器的近端的斜视图。
图10图解了在其柔性部位切出有更短的横向槽并且减少或者完全消除了柔性部位近端附近的一些T形槽以提高该部位中的抗弯能力的外管。
图11图解了其中已经移除了断开侧、仅留下连接侧和远端的一内管。
图12图解了在柔性部位内可转向经中隔穿孔器中的管状结构的截面图,其中内管中的分开槽基本上处于内部管的中点或者中心处。
图13图解了柔性远侧部位内的可转向经中隔穿孔器的管状结构的横截面图,具有偏心的分开槽。
图14图解了包括楔形榫头或者联锁凹槽以增大对转矩或者侧向移动的抗扭阻力的外管的远侧柔性部位的一部分的顶视图。
图15图解了包括楔形榫头或者锁定凹槽以减小扭转弯曲或者侧向移动的外管的远侧柔性部位的一部分的侧视图。
图16到20图解了可转向经中隔穿孔器在形成从心脏的右心房至左心房的通路中的用途。
具体实施方式
图1图解了一种穿孔器、针或者导管组件1的侧视图,具有起到弯曲穿孔器的远端作用的整体式铰接或弯曲机构。穿孔器组件1包括内管2、外管3、管心针或充填器线4、充填器握持拉环5、旋塞6、内管指示器7、外管指示器8、内管套节9和外管套节10。内管2的远端削尖成适合穿刺卵圆窝的针或者穿孔器。管心针或者充填器线4附接到充填器握持拉环5上。管心针或者充填器线4穿过内管2的中央管腔插入并且可滑动地设置在其中。
图2图解了轴向伸长外管3的远端的部分分离的侧视图,其具有远侧的柔性部分11和近侧的较小柔性部分12。远侧的柔性部分是由蛇形切口部分13形成的,其具有多个切入管的横向或径向槽14和在外管的任一侧上与每个径向槽相交的多个纵向槽15。所述多个径向槽14用来使得外管3中设置径向槽14的部位比没有槽的近侧部位12更柔性。(所述柔性部分可能相对于较小柔性部分提供了柔性,但是无论如何,其削弱了管中可能包括许多纵向槽、穿孔、较薄壁厚等以及所描绘的蛇形切口的节段。)多个纵向“T”形切口用来进一步使得外管3中存在“T”形切口的部位比管中不存在所述“T”形切口的部位更柔性。纵向“T”切口15是可选的但是在所选的弯曲部位中增大外管3的柔性是有益的。径向槽14可以优选大约0.1英寸到大约0.8英寸的范围且更优选大约0.15英寸到大约0.5英寸的范围间隔开大约0.02到大约1.0英寸。部分横向槽14之间的间距可以改变。朝向外管3的近端的径向槽之间的间距可能为大约0.3英寸,而更靠近外管3的远端的径向槽14可能间隔开大约0.15英寸。所述间距可以按阶跃函数变化,其可以从外管3的一端移动至另一端逐渐地变化,或者其可以增大并减小一次或多次以产生某一特定的柔性特性。增大的间距增大了通过压缩径向槽14可达到弯曲的最小半径,而减小的间距允许弯曲的更小最小半径。
径向槽14的数量,或者选择性地,具有纵向T形切口15的径向槽14的数量可能总计在大约4到大约50之间,优选总计在大约6到大约25之间,且更优选在大约8到大约15之间。如图2中所示,存在12个径向槽14,每个以“T”形槽15来改造。径向槽14可能不同地成形。例如,径向槽14可能对于纵轴线成除90度以外的角度、弯曲、V形、Z形、W形等。在其他实施例中,“T”形槽15可能例如具有沿“T”形切口15的任一部分大致横向于纵轴线的切口。在又一其他实施例中,远侧的柔性部分11可能包括线圈、螺旋线或者弹簧的部位,该部位可能进一步在一侧上包括支柱(backbone)。
外管3可能具有大约0.020到大约0.1英寸的外径,优选外径大约0.040到大约0.060英寸,且更优选直径大约0.045英寸到大约0.055英寸。在所示实施例中,外径为大约0.048英寸,而内径为大约0.036英寸。外管3的内径可能介于大约0.0.010英寸到大约0.090英寸的范围。
图3图解了轴向伸长内管2的远端。内管具有从管的近端至管的远端的管腔,并且包括近侧未切部分16p(当组装到外管内时其将驻留在外管的近侧未切部位12内)和由纵向槽17形成的柔性部位及开槽部分16d。所述开槽部位的特征为,成角度的导入槽18、悬伸式部分圆柱19、部分圆柱20和内管21的远侧未切末端21。远侧末端21使自由侧的部分圆柱19与部分圆柱20互连,从而部分圆柱19在其远端处附接至内管的其余部分。连接侧是跨越整个近侧部分和远侧末端的整个管的一半圆柱20。自由侧是从远侧末端的整个管处悬伸的(尽管其可以从近侧部分的整个管处悬伸)、与部分圆柱20径向地并列的一部分圆柱。如下所述,所述悬伸的部分圆柱用来在组装穿孔器的弯曲期间限制外管柔性部分的塌缩,而长槽提供了允许外管的偏转所需的柔性。部分圆柱19和部分圆柱20大部分是由在内管中切出的槽方便地形成的,但是也可以通过焊接、粘合剂、紧固件等相互附接到一起。
至纵向槽17的引入端18是有利地成角度的以防止通过中央管腔插入的引导线、管心针或者其他导管被卡住或者碰到边缘。成角度的引入端18作为导引件以协助使管心针、充填器或者导引线穿过引入端18并进入可转向经中隔针的远侧部位。引入端18与纵轴线(完全横向的)成大约-80度(所述角度可能是倒转的)到大约+2度之间的角度,并且优选大约+5度到大约+20度,且最佳角度为大约+8度到大约+15度。在所示实施例中,引入槽18与纵轴线的角度为大约10度。引入端18的第二特征是,当两个管3、2相互附接时其定位或者设置在邻近外管3中最近侧的“T”形槽15处(见图4)。引入端18可能设置在邻近最近侧的“T”形槽15的至少1-cm处,并且优选邻近最近侧的“T”槽15至少2-cm处,以便远侧部位中的弯曲不会扭曲引入端18并且不会引起内部管腔的扭结、未对准或者狭缩。
内管2可能具有稍微小于外管3的内径的外径以便可以施加比较小的力迫使内管2按平滑方式在外管3内纵向地或者轴向地移动。在所示实施例中,内管2的外径为大约0.033英寸以在两个管3与2之间赋予了大约0.0015英寸的径向间隙。内管2的内径可能比内管2的外径小大约0.002到大约0.015英寸的范围。在所示实施例中,内管的壁厚为大约0.006英寸,所以内管的内径为大约0.021英寸。内管2的管腔可以被定尺寸成可滑动地接收管心针或者充填器,如图1中所示。一般的管心针线的直径范围可能介于大约0.01到大约0.23英寸的范围,优选的直径范围介于大约0.012到大约0.021英寸。在另一实施例中,外管3具有大约0.050英寸的外径和大约0.038英寸的内径。在该实施例中,内管2具有大约0.036英寸的外径和大约0.023英寸的内径。内管3与外管2之间的径向壁间隙为大约0.001英寸,并且直径间隙为大约0.002英寸。
内管2沿着其近侧未开槽部位12将力从内管2的近端传递至引入端18,在该引入端18,力继续沿着连接侧20被传送至远端21。外管3沿着其近侧未开槽部位12传递力。施加至远侧的、具有槽14的柔性部分的轴向拉力以不对称方式引起外管变形,则使外管3中包括部分横向槽14的那侧如果槽14被扩大则形成外弯曲部,并且如果槽14被压缩则形成内弯曲部。优选如此施加引起弯曲的力,即将部分横向槽14压缩至其中间隙闭合的点处,并且不再继续压缩,然而还可以施加力来扩大槽14,然而对弯曲的限制是不适当的,因为除了外管3的材料性能之外,横向槽14可以按无限制方式打开。
通过纵向槽17和引入端18与连接侧20分开的内管2的分离侧19用来维持不变形的管几何形状并且提供变形抗力而同时有助于维持内部管腔的圆形结构,并且提供鞋拔或者漏斗作用以当导引线或者管心针向远侧前进时引导其通过。与力传递构件12分开的分离侧19不能提供任何实质的纵向负载支承结构,虽然在其远端处,其集成或者附接到远端21上,存在一些拉伸负载承载能力。内管2可以被称为剖开式管并且基本上沿悬伸侧19的整个长度不承载压缩载荷或者张力。
可以通过诸如但不限于电子放电加工(EDM)、线EDM、光刻、蚀刻、激光切割、逆铣等方法来制造外管3中的径向槽14和T形槽15以及内管2中的纵向槽17和引入端槽18。还可以应用不同的槽结构,诸如弯曲槽、合成槽、之字形槽等。部分横向槽14可以配置有槽舌榫或者楔形榫头设计以防止或者最小化柔性部位中外管3的横向移动或者扭转。例如,槽舌榫或者楔形榫头(未显示)可能大致在两个“T”形槽之间居中。所述部分可能是成组的,以便可以例如使用线EDM来切割多个管以降低制造成本。可以通过上述方法夹紧、固定和蚀刻多达20到30个管。
图4图解了铰接式经中隔穿孔器的远端22的侧视图。远端22包括外管3和内管2,外管3进一步包括径向槽14,内管2进一步包括纵向缝17和远侧末端21。焊接部23在外管3中外管的柔性部位远端近侧的点处将外管3的远端附接至内管的连接侧20。该焊接部优选是基本上限定内管的整个周边的环形焊接部。外管3和内管2如此围绕纵轴线可旋转地定向,即内管2的连接侧20大致与外管3在包含部分横向缝14的那侧上对齐并附接或在焊接部23处焊接至其上。换句话说,槽和连接侧是沿周向对齐的,意味着其定位在沿管周边的同一线上或者其附近。焊接部23可能是点焊接部,其仅将外管的一小部分周边固定到内管的对应一小部分周边上。在该情况中,槽和外管与内管之间的固定点周向地对齐,意味着其定位在沿管周边的相同点或其附近。部分横向槽14、T形槽15和纵向槽17的宽度可能介于大约0.001到大约0.050英寸的范围,优选范围介于大约0.005到大约0.020英寸。在图4中所示的装置中,适合用作被用于马林斯导管内的经中隔穿孔器,槽14、15和17为大约0.010英寸。外管3上的部分横向槽14的宽度在受压中可用于为外管3沿着包含部分横向槽14的那侧在受压中可弯曲到什么程度提供至少一些限制。注意到,内管2的远端延伸到外管3的远端以外。内管2延伸到外管3的远端以外大约10mm到大约20mm或更多。远端22可能还包括一个或多个独立的不透射线的标记24。该结构保证减小装置的复杂性、增大运行的可靠性并且相对于其他可转向装置降低了制造成本。所述系统还当远端22是如所图解的直的、如图5中的弯曲形或者在直的与最大弯曲形之间任何结构中的弯曲形、转弯、偏转、转向或其他变形时保证高刚度。铰接式经中隔穿孔器必须是坚硬的,具有高裂断强度并对来自外部源的弯曲具有显著抵抗力,因为其必须在非常小直径的穿孔器管的非常长、2到4英尺长的端部处推动切口穿过组织。因此,全金属管的穿孔器可以将力从其近端传递至其远端,这是基本上聚合物导管差不多不能胜任的。对于经中隔刺穿的特定目的,携带所述穿孔器的导管比铰接式经中隔针的效率低。
铰接式经中隔穿孔器的远端22通常是由具有足够的射线不透性或者射线密实度的金属制成,其在荧光检查法或者X射线成像下是清晰可见。然而,如果情况不是这样,则可以将辅助的不透射线的标记24附接到外管3、内管2或者两者上。所述不透射线的标记可能包括诸如但不限于钽、金、铂、铂铱矿、钡或者铋化合物等的材料。
取决于直径,介于大约0.0005英寸到大约0.008英寸之间的径向间隙的外管3的内径与内管2的外径之间的紧公差促使两个管3和2一起工作以维持横截面的基本上圆形而不呈椭圆形、弯曲、扭结、或者变形。两个管3和2可以由相同材料制成,或者用于每个管3、2的材料可以不同。适用于管构造的材料包括但不限于,不锈钢、镍钛合金、钴镍合金、钛等。某些非常硬的聚合物可能也适用于制造管3、2,包括但不限于,聚酯、聚酰亚胺、聚酰胺、聚醚酮醚(PEEK)等。内管2、外管3与槽14、15、17、18之间的关系用来在诸如以上列举的高模量材料中提供柔性和成形,所述材料通常不适用于柔性。所述管3、2的内部和外部的表面光洁度优选被磨光或者非常平滑的以减小两个管3、2之间因其非常小的横截面和其较长的长度的滑动摩擦。可以将诸如但不限于,硅油、亲水性水凝胶、亲水性聚氨酯材料、PFA、FEP或者聚四氟乙烯(PTFE)涂层的润滑剂应用到外管3的内径、内管2的外径或者两者上来减小滑动摩擦以促进两个管之间的纵向相对移动,这对于铰接靠近铰接式经中隔护套的远端22的柔性的开槽部位是必需的。外管3的外表面可以以聚合物层包覆,每一个基本上是弹性材料或者不是,其可以覆盖住槽14、15等并且对外部环境提供平滑的外表面。外表面可以附接至外管3的外部或者配置成在其上滑动。
内管2可能在柔性部位被纵向地剖开,并且内管2的远端的一部分或者整体可以附接至外管3并被功能性地保持。在一些实施例中,内管2的远端21可以如此保持,即在内管2中形成圆柱形远侧部位21,并且该整个圆柱形远侧部位或者其未从外管3的远端向远侧伸出的那部分可以围绕外管3周边的一部分或者整体焊接到外管3上。如果仅内管2的一部分焊接到外管3上,则焊接部大致居中地设置在外管3中包含部分横向槽14的那侧上是有利的。圆柱形远侧部位21是有利结构,而不是在一侧上完全切掉内管2,因为远侧部位21从外管3的远端向远侧伸出以形成穿孔器的末端,所述末端进一步包括配置成刺穿心肌组织的削尖末端25(参见图11和13)。
图5图解了处于弯曲结构的铰接式经中隔针的远端22。该视图显示了远端22、外管3、内管2、外管管腔11、外管的近侧部位的远端12、内管2的远端21、削尖的远侧末端25、多个外管的纵向切口或槽15和多个外管的部分横向切口14。外管的部分横向切口14当管中设置横向切口14的那侧处于压缩时提供了靠拢的空间。这种压缩是通过操作近侧地设置的转移机构相对于内管2向远侧推动外管3,或者反之相对于外管向近侧拉拔内管所产生的。当部分横向切口14的间隙闭合时,进一步压缩是难得多的,因为当不存在用于压缩的进一步的间隙时外管3显著地变刚硬了。内管2同心地套设在外管3内的复合结构是比较刚硬的并且对扭结是有抗力的而无论产生的弯曲量。当使用铰接式经中隔针来使诸如马林斯引入器或者其他导引导管的另一导管偏转时,这种刚度是必要的。
对于远端的优选曲率半径可能介于大约1英寸到大约6英寸之间的范围,更优选范围介于大约2英寸到大约4英寸之间,且更优选的范围介于大约2.5到大约3.5英寸之间以为了刺穿心房间隔的目的。例如,在脑血管、心脏动脉等中甚至更小的曲率半径可能是合适的。曲率半径无须是恒定值。柔性部位的近端可能具有比柔性部位远端处的那些间隔开更宽的部分横向切口,使得柔性部位的远端比近端弯曲成更紧的半径。在其他实施例中,柔性区域的远侧部位可能比近端柔性小。
有利地使用蚀刻、电解抛光、钝化、喷砂、去毛刺、机械加工或者其他工艺来有利地处理外管3中的部分横向切口14和“T”形槽以倒圆部分横向切口14的外部边缘。因此,钝化或倒圆所述边缘以使其不尖锐到引起铰接式经中隔针从聚合物导引导管内部挖下、削下或者刮下材料的程度,因为这是使用铰接式经中隔针而不使用当穿过聚合物护套向远侧前进时可能从护套或者导引器内径上刮下或者削下材料的预弯曲、非铰接的经中隔针或其他穿孔器的好处。
远端25优选是尖锐的,但是其也可以被稍微或者完全钝化。在部分或者完全钝化的远侧结构的情况中,远端可操作地连接至电源或者射频(RF)能量源并且可以使用电能或者射频能量来形成刺穿孔。由内管2从套节49处输送能量,内管2优选与外管3电绝缘,在套节49中可将电能或者射频能量应用至远侧末端25。
图6和7图解了铰接式经中隔穿孔器通过扩张器或者充填器37的中央管腔36前进的远端22,所述扩张器或者充填器37进而设置在马林斯导引导管38内。远端22包括包含多个部分横向切口14的外管3和包含削尖的远侧末端25的内管2。削尖的远侧末端25包括坡口39、一个或多个小平面40、尖点41和倒圆或钝化的外边缘42。充填器37进一步包括中央管腔36。导引导管38也包括中央管腔43。导引导管38及其充填器37通常在远端附近弯曲。当经中隔穿孔器的远端22穿过充填器37的管腔36向远侧前进时,通过包含远端25的朝向弯曲部的外侧的倒圆边缘42来防止从充填器37的内壁上刮下碎片。远侧的尖端25包括坡口39以形成具有尖点41的削尖的组织穿孔器。如所图示的,坡口的尖点41与穿孔器中具有槽14和悬伸的部分圆柱19径向地对齐。小平面40是可选的,但是可设置1到大约10个的数量。坡口39可能以单一角度形成,或者具有复合弯曲部分。在一些实施例中,坡口39可以自管轴线的横向成大约20到大约80度的角度地形成,优选介于自横向大约30到大约60度的范围,并且最优选介于大约40到大约50度的范围。尖点41可能是三维或者二维点,例如本文所示的点41。
图7图解了还包括管心针4的铰接式经中隔穿孔器的远端22。管心针包括芯线或管44、近侧锁定及握持拉环5(图1中所示)、自扩张笼45和倒圆的远侧末端46。所述笼当撤回到内管2中时被约束成小直径结构,并且当被向远侧推动到内管外时弹性地或者假弹性地(pseudoelastically)扩张至大直径结构。大直径结构具有足够大的直径以阻挡内管锋利的远侧末端刮削充填器37或者导引导管38的内壁。具有形成于管心针的远端上的所述笼,管心针4作为护罩来协助使尖锐的远端变钝。可以使用诸如冷轧或者回火的方法由例如但不限于不锈钢、镍钛合金、钴镍合金、钛等材料制造管心针4以获得相当大的弹簧条件。其中芯线包括管,如图7中所示,通过弹簧不锈钢或者假弹性镍钛合金的剖开管来形成塌缩护罩特征45,包括由纵向地延伸的槽或者开口48限定出的多个纵向延伸的支柱47。支柱被向外偏置以在不受约束时形成径向鼓起的笼,其当被插入管腔中时可以轻易地变形成装配到内管的管腔内的小直径结构。开槽的管护罩45优选集成到芯线44上,但是可以作为独立结构设置在芯线上。护罩45的向外鼓起的量(大直径的、未约束构造中的外径)不必很大,但必须足以妨碍内管锋利的远侧末端与周围导管部件的内壁之间的接触。处于大直径结构的笼仅必须比内管的内径大,而且优选等于或超过内管的内径。可以具有如其他附图中所描绘的可转向布罗肯布鲁格结构或者没有该结构地获得管心针和笼与中空布罗肯布鲁格针相结合的优点。另外,管心针可以替换为导引线、设置在导引线的远端上的自扩张笼,如关于管心针所描绘的。管心针的可扩张远端是有益的,因为内管相对于ID(大约0.013到0.023英寸)的较大壁厚(大约0.004到0.009英寸)可能不能充分地防止内管的锋利远端不破坏导管的内部和从该处向远侧伸出,即使具有安装好的不可扩张的管心针。如果是由非弹性的或者非超弹性材料而不是自扩张材料构成的,则可以强迫打开和关闭管心针的可扩张远端。
外管3可以被改造以调整刚度。增加从远侧向近侧移动时外管3上的抗弯能力可能是优先的。抗弯力中的该增大同外管在柔性部位的近端比远侧部位弯曲更严重的趋向相抵触。有可能配置所述弯曲以使弯曲半径是大致恒定值或者以便朝向可弯部位的远端移动时产生更大弯度(更小的弯曲半径)。可以在更近侧切出具有减小深度的部分横向槽14以增大由外管3赋予的抗弯能力。在更近侧部位可将部分横向槽14切得更窄以减小可以闭合的槽14的距离。在外管3的柔性部位的更近侧部位可以减小T形槽15的长度或者取消T形槽15。可以给一些部分横向槽14加入弹性材料的缓冲器或者充填器以减小部分横向槽14可以压缩的量。一旦与T形槽15对应的部分横向槽14在外管3的弯曲下已经闭合,则抵抗并基本上停止进一步的弯曲。通过定制部分横向槽14的宽度2和间距,对于给定导管可以定制具体的最终弯度。
图8图解了铰接式隔膜穿孔器的套节49的侧部截面图。套节的部件,包括顶丝机构,提供了用于相对于外管拉紧内管的器件。设置在外管2和内管2的近端处的套节49包括套节本体50、顶丝手压开关51、鲁尔锁定接头54、箭头指示器55、带键管腔56、定位螺钉或销57、顶丝本体58、控制旋钮61、外管焊接部66、定向标记67和内管焊接部68,所述顶丝手压开关51还包括手压开关把手52和手压开关穿过孔53,所述顶丝本体58还包括多个螺纹和中央管腔60,所述控制旋钮61还包括多个螺纹62、中央管腔63、突起64和周向凹进部65。套节本体50可能还包括多个凹进部或者互补结构69。手压开关51通过焊接、集成制造、紧固件、粘合剂等附接到手压开关把手52上。利用“C”形锁定垫片、紧固件、螺钉、销等(未显示)将手压开关51保持在套节本体50中的横穿孔内,该横穿孔在所示实施例中是锥形的。手压开关51可以围绕其纵轴线转动来以套节本体50的轴线和中央管腔对准穿过孔53,或者其可以侧向地转动以迎着流体流关掉并密封管腔。鲁尔锁54可以附接至套节本体50或者与其整体地制造。旋钮61被诸如销的定位螺钉57的固定元件保持在套节本体50内,当被驻留在周向凹进部65内的定位螺钉、突起或者销57受约束时其阻止轴向移动但允许旋转运动,所述周向凹进部65集成地形成或附接到旋钮61上。顶丝本体58能够在套节本体50内轴向移动,但是被顶丝本体58外部上的平面或特征阻止围绕长轴的转动,所述顶丝本体58由带键管腔56中的平面或特征约束。旋钮61包括位于其内部管腔上的、与顶丝本体58上的外螺纹62接合的螺纹。因此,旋钮61的转动以机械增益地促使顶丝本体58轴向地向近侧或者向远侧移动。可以使用手动动作或者使用电动机或其他机构(未显示)来迫使旋钮61转动。外管3通过外管焊接部66附接到顶丝本体58上。内管2通过内管焊接部68附接到套节本体50上。内管2的中央管腔可操作地连接至套节本体50的中央管腔、手压开关穿过孔53和鲁尔接头54的管腔。
旋钮61可能包括标记67以允许使用者看到其相对于套节本体50的旋转或周向位置。所述标记67可能包括例如但不限于印刷的字母数字(未显示)、诸如点、正方形等多个几何形状的结构,或者标记可能包括如对于印刷标记所述的相似构造的隆起或凹入(压花)特征。在一实施例中,旋钮61可能包括位于每一个小平面上的数字以便在所示实施例中可以从1到6地计数所述小平面。旋钮的标记67可能还包括如图所示的隆起结构,为了容易看到可以对比色进一步增强所述标记。
旋钮61可能还包括附接至其上或者与其集成的一个或多个互补结构,例如配合到附接或集成至套节本体50的近端的定位槽65中的多个突起64。伸入到套节本体50的定位槽中的所述突起一旦转动到正确位置则可以提供棘爪效应或者咔哒音以及提供对旋钮61无意中运动的阻力。在一些实施例中,可以朝套节本体50偏置旋钮61以确保例如突起和定位槽的互补结构进入正确接触。在其他实施例中,旋钮61可能包括棘爪系统以进一步控制其相对于套节本体50的转动。在其他实施例中,旋钮61可能包括一个或多个定位槽(未显示),而套节本体50可能包括一个或多个互补的突起(未显示)。仅当使用者要求而非意外时或者不是当维持其旋转位置并因此维持管远端处弯度所需时移动旋钮61是有益的。棘爪位置或低能量位置或设定点的的数量可能介于每360度大约2到大约20个的范围,优选棘爪位置的数量介于大约4到大约12个。
图9是图8的近侧转向机构的透视图,显示了可转向经中隔针的操纵套节49,包括用于使针转向的部件。近侧套节包括旋钮61、套节本体50、进一步包括指示器70的箭头指示器、旋塞本体71、手压开关51、手压开关的把手52和鲁尔接头54。尖端72与针的坡口的尖点(和针的弯曲方向)对准,并且提供了陆标,通过该陆标,外科医生可以确定坡口的尖点在马林斯导管内的定向。
图10和11图解了用于外管和内管的备选实施例。图10图解了外管3,其包括管腔11、近侧管壁12、多个部分横向槽14、多个T形槽15、短的部分横向槽73、稍长的部分横向槽74和标准长度但具有缩短T形槽75的横向槽14。最近侧的部分横向槽73穿入小于标准的部分横向槽14的。第二(向远侧移动)部分横向槽74比槽73稍长,并因此在所述部位中更柔性并且需要更少力以产生弯曲。第三部分横向槽包括缩短的T形槽75,所述缩短的T形槽75减小了管在给定的恒定弯曲力下弯曲的能力。
图11图解了内管2,其包括管腔、近侧部位12、连接侧20、远端21、削尖末端25和远端21的近端处的斜面导引处76。延长的半管部位77基本上在外管的蛇形切口部位的整个长度上延伸,并且可能沿着装置的长度至少延伸与蛇形切口部位一样长。如所示,半管部位刚好从外管的蛇形切口部位近侧开始,并且向远侧刚好在蛇形切口部位的远侧且刚好在将内管附接至外管的焊接部近侧的一点处终止。半管部位的开口侧在装置中与蛇形切口部位的T形槽相同的侧上(也就是说,半管部位的开口侧是周向地与T形槽对齐的)。断开部位的近端可能向远侧移动以增大特定部位(通常是该远侧的最近侧部分、柔性部位)中内管2的刚度,
因为,在使用可转向经中隔针期间,使针向远侧前进穿过已经放置好的马林斯导引导管,直的可转向经中隔针能够向前穿过已经放置好的引入器、护套或者导引导管中的任何弯曲部分是有利的。因此,在某些实施例中,坡口如此定向,即削尖末端25的尖点朝向弯曲方向定向。如此,可转向的经中隔针当处于其直的构造时可被推入到引入器、护套或者导引导管的弯曲部位中并且不使尖点钻入引入器、护套或者导引导管中。削尖末端25中远离所述尖点的那侧可能还包括被稍微倒圆以使其甚至更防止损伤并且平滑以便其可以在不从引入器、护套或者导引导管的壁上掘下任何材料的情况下沿着引入器、护套或者导引导管的弯曲部分滑过或者滑动。
内管2可以维持压缩以在被弯曲之后使外管3在远端处的弯曲返回直的并且甚至沿另一(或者相反)方向弯曲至直线的以外是有利的。为了维持压缩,断开侧19在套管的中心或中点处或者大体上附近与连接侧20分开是有利的。取决于将断开侧19与连接侧20分开的槽17的宽度,槽的位置可以偏离中点,但是这取决于内管2的壁厚和槽的角度。在一优选实施例中,断开侧19与连接侧20之间存在干涉,以使有断开侧和力传递构件可能基本上不能内向移动的情况,所述情况将具有阻塞管腔、限制流体流过其中、卡住必须在其中纵向地移动的管心针或其他导管或者翘曲到足以阻止在连接侧20上施加纵向的压缩力。
图12和13是内管在分割部位中的横截面。图12是套设在外管3内并且在铰接式隔膜穿孔器的柔性部位中与外管2分开环形径向缝隙78的内管2的径向截面图,其中内管2被大致(或者基本上)在横截面的中线或者中心线处的裂口或者间隙17分成两个大致或者基本上相等部分,连接侧20和断开侧19。
图13是套设在外管3内并且在穿孔器的柔性部位中与外管22分开环形间隙78的内管2的径向截面图,其中内管2被显著偏离横截面的中线或者中心线的裂口或者间隙17分成两个显著不相等部分,连接侧20和断开侧19。
断开侧19因其刚度和其不变形能力保持非常接近于外管3,以便断开侧19的边缘可以超越连接侧20的边缘并从而两侧20和19自中心线径向平移地保持。如果间隙17太大或者两侧20、19足够小至装配在另一侧的边缘内,则一侧朝向中心线的位移和连接侧20或者19的偏心定向将使得连接侧20受压翘曲并且不能弄直弯曲的经中隔针。另一问题可能是损失了弯曲方向的可扭转性和可预测性。图12和13中所示实施例两者都维持内管的连接侧20相对于断开侧19的周向和径向定向并且促进远侧末端的高精度偏转。
在优选实施例中,当针的外径为大约0.050时,环形间隙78被最小化并且维持在大约0.0005到0.002英寸之间。此外,裂口或者间隙17应当尽可能最小并且在优选实施例中可能介于大约0.002英寸到大约0.015英寸的范围,具有大约0.004到0.010英寸的间隙是最优选的。
图14和15图解了外管3的备选实施例。在图14中,外管3在远侧柔性段的部位中包括通过楔形接头80联接的多个短的纵向节段79,所述楔形接头80包括宽松地装配到楔形间隙82中的楔形榫头81。
在图15中,其是从图14偏离90°地观察的图14中所示的同一外管3,外管3在楔形接头的部位中包括径向地偏离楔形榫头和楔形榫头接收器90°地设置的部分横向槽83,所述楔形榫头接收器通过周向槽14与楔形榫头联接。纵向T形槽15是可选的或者其可以不同地配置。
图16到20图解了可转向经中隔穿孔器在形成从心脏的右心房至左心房的通路中的用途。图16图解了患者的心脏的一部分,包括右心房91和左心房92及将两者分隔开的卵圆窝93,以及下腔静脉94和起初在右心房中的导引导管38与充填器37远端处的上腔静脉95。导引导管的远端当设置在右心房内时被弯曲至某一程度,并且可以在腔静脉和右心房内被稍微弄直。
图17图解了开始插入可转向经中隔穿孔器1。将穿孔器推过导引导管38或者充填器37的管腔直到其远侧末端设置在导引导管38或者充填器37的远端内。在插入期间,当将穿孔器推过导引导管38或者充填器37时,通过相对于外管3拉拔内管2(或者反过来,相对于外管推动内管,反之亦然)来使穿孔器的远端转向以避免或者减少锋利的末端抵靠导引导管38或者充填器37的内壁刮下碎片。图18图解了弯曲导引导管38、充填器37和经中隔穿孔器1的结合组件的远端的步骤。这通过弯曲经中隔穿孔器1的末端,再相对于外管3拉拔内管2,转动近侧套节上的旋钮以在内管2上向远侧推动外管3来完成。经中隔穿孔器1的偏转同时将迫使导引导管38(和充填器37)偏转。如所示,弯曲组件的远侧末端,并转动组件,以将所述末端与导引导管38管腔的出口并列地放置到卵圆窝处。在此刻,如图19中所示,相对于导引导管38向远侧推动经中隔穿孔器以将所述锋利末端推出导引导管38和/或充填器37的远端并穿过卵圆窝。最后,如图20中所示,将导引导管38和/或充填器37推过由穿孔器2所形成的穿孔,以便将导引导管38的远侧末端设置到左心房92内。现在可以向近侧撤回经中隔穿孔器1(和充填器37,如果仍在原地)并从导引导管38中取出。现在可以利用导引导管38的空管腔将任何期望的工作导管穿入到左心房中。
因此,图16到20中所描绘的方法需要在身体的管腔或者中空的器官壁中穿出孔,需要外科医生(或者心脏病专家)执行以下准备步骤,(1)将导引线插入患者身体的管腔中并且布置至靠近靶位的位置处,所述靶位是器官或者身体管腔壁(例如,卵圆窝),并且(2)在导引线上将导引导管推进到靶位处,其中导引导管是具有近端、远端和经由其延伸的管腔的轴向伸长结构,并且(3)从导引导管中取出导引线。紧接着,外科医生,(4)使用一种如图1到15中所描绘的轴向伸长穿孔器,将穿孔器插入导引导管的管腔中并将穿孔器布置至靶位处,其中所述穿孔器包括整体式转向机构和用于相对于外管张紧或压缩内管的器件,所述转向机构包括位于穿孔器远端处的可转向部位,穿孔器自身包括具有纵向槽的内管和具有设置在所述纵向槽上方的蛇形切口部位的外管,其中所述穿孔器是基本上直的并且未被弯曲,并且依照要求选择性地使所述可转向部位转向以越过导引导管中的任何弯曲部分。随着将可转向部位设置到导引导管的远端内,外科医生利用整体式转向机构使靠近穿孔器远端的可转向部位转向,以便在远端处显著地弯曲穿孔器和围绕的导引导管并且朝向并抵靠靶位定向。在完成将轴向伸长穿孔器插入导引导管中并且将穿孔器布置到靶位的步骤之后执行该步骤。紧接着,外科医生或者心脏病专家从导引导管的远端处前推穿孔器的末端并且利用穿孔器在身体管腔或者中空器官壁中穿出孔并推进穿孔器穿过身体管腔或者中空器官壁。最后,外科医生或者心脏病专家从导引导管中取出穿孔器和整体式转向机构。
本文所公开的转向机构可以非常薄的壁和较大的内径(ID)与外径(OD)比的构造来提供较高的精度、可重复性、力、裂断强度、扭转控制等,所述转向机构包括相互之间仅沿纵轴线移动的两个或更多个套设的轴向伸长圆筒形管。管中的一个包括部分横向切口或者复合横向间隙,并且另一管包括基本上沿柔性部位的长度延伸的裂口。所述带缝管的断开侧可以被移除以便仅保持一部分成形的连接侧。然而,在优选实施例中,实际上保持在远端处的断开侧未被移除而是用来填充外管3的管腔内的空间以防止扭结、增大裂断强度、防止管腔塌缩并且考虑到用于引导中心的管心针或者导管。现有技术的拉线式转向装置需要更大的壁厚,该更大壁厚针对给定的外径减小了内部管腔的尺寸,或者其受控下在装置的远侧末端处不具有与装置近端精确相同的运动。
然而,以上公开的具有带缝内管和蛇形切口外管的经中隔穿孔器受压时可以维持其结构并提供精确的控制,并且维持大于任何其他种类的可转向经中隔穿孔器的中央管腔。甚至当内管被纵向地开槽时出现对翘曲的阻力,因为利用不会让内管(甚至在压缩下)弯曲到其笔直定向外的非常紧容差将内管约束在外管内。
所述穿孔器可用于在身体上的不同结构中形成孔。其主要配置成作为供刺穿卵圆窝以获得从右心房到左心房的通路中使用的一种铰接式或者可变偏转的布罗肯布鲁格针。然而,所述可转向穿孔器可用于例如,经腔血管吻合术、活体解剖弥补或者中空器官或管腔壁中成孔的应用。穿孔器可用于心血管系统、肺系统、胃肠系统或者包括管状管腔的任何其他系统中,其中最低限度侵入地出入是有利的。穿孔器在操作中可配置成带芯或者不带芯的,取决于远端的形状并无论穿孔器的充填器或者圆形中空端是用于执行穿孔操作的。穿孔器促进经中隔过程的完成、简化导管的布置、使插子碎片脱落到患者中的机会最小并且提供了心脏病专家定向穿孔器以用于完成过程的能力。
当用于经中隔穿孔器的说明中时,术语近侧和远侧与其用于医疗装置技术中一样使用。术语近侧是指沿着装置的长轴靠近使用者、把手和装置的插入点的位置。术语远侧是指远离使用者、把手和插入点的点。导管的远侧端和近侧端可能或可能不与患者脉管系统的远侧部分和近侧部分一致,例如,其中经中隔穿孔器被插入其远侧为心脏的(为脉管系统的起点的心脏是脉管系统的其余部分的近侧)腿上的静脉中。
虽然已经根据其发展的环境描述了装置和方法的优选实施例,但是其仅说明了本发明的原理。不同实施例的元件可结合到每一个其他类型中以获得与所述其他类型结合的那些元件的优点,并且不同的有益特征可以应用在单一实施例中或者相互结合。在不脱离本发明精神和所附权利要求的范围的情况下可以设计出其他实施例和构造。
Claims (15)
1.一种经中隔穿孔器,包括:
外管(3),其特征为具有近端、远端和处于所述远端的柔性部位(11),所述柔性部位的特征为具有近端和远端;以及
内管(2),其特征为具有近端和远端,所述内管在其远端附近具有柔性部位(16d)和适于穿刺身体组织的远侧末端(21);
所述内管(2)设置在所述外管(3)内,从所述外管的近端延伸至所述外管的远端并且在所述外管的远端之外向远侧终止,所述内管在所述外管中接近所述外管的柔性部位的远端的连接点(23)处固定到所述外管上。
2.如权利要求1所述的经中隔穿孔器,还包括:
连接到所述外管与所述内管上的近侧套节(49),和位于所述近侧套节上的器件(50、58、59、61),以用于相对于所述外管向近侧张紧所述内管。
3.如权利要求1所述的经中隔穿孔器,其中:
所述外管(3)的柔性部位(11)包括所述外管的、在所述外管的壁中蛇形地切出多个径向定向槽的节段,所述径向定向槽(14)基本上沿所述外管的一侧径向地对齐;以及
所述内管的柔性部位(16d)包括所述内管的、具有纵向定向槽(17)的节段。
4.如权利要求3所述的经中隔穿孔器,其中:所述内管的纵向定向槽(17)在一端处以穿过所述内管的侧壁的开口(18)终止。
5.如权利要求4所述的经中隔穿孔器,其中所述内管(2)在与所述径向定向槽(14)径向对齐的点处固定到所述外管(3)上。
6.如权利要求4所述的经中隔穿孔器,其中所述内管的纵向定向槽(17)在其近端处以穿过所述内管的侧壁的所述开口(18)终止。
7.如权利要求4所述的经中隔穿孔器,其中:
所述内管(2)的纵向定向槽(17)具有近端和远端,所述纵向定向槽(17)的近端终止于穿过所述内管的侧壁的所述开口(18),所述纵向定向槽(17)的远端终止于所述内管(2)的远端(21)的近侧,限定了未与近侧内管分开的该内管的侧部(20);并且该经中隔穿孔器还包括:
所述内管与所述外管之间的连接点(23),从而所述内管的未与近侧内管分开的侧部(20)在所述外管的包含径向定向槽(14)的那侧上附接到所述外管(3)上;并且还包括:
连接到所述外管与所述内管上的近侧套节(49);
其中所述套节包括内部管腔(63),所述内部管腔能够接收顶丝本体元件(58)并且阻止所述顶丝本体元件(58)围绕所述套节的纵轴线转动,其中所述内管被约束以不相对于所述套节移动;
附接到轴向伸长外管的近端上的顶丝本体元件(58),其中所述顶丝本体元件(58)包括位于其外表面的至少一部分上的移动件螺纹,并且此外其中所述外管(3)可以响应于所述顶丝本体元件(58)的移动而轴向地移动;
附接到所述套节(49)上、能被使用者转动的旋钮(61),其中所述旋钮包括位于内部管腔上的旋钮螺纹,从而所述旋钮螺纹与所述移动件螺纹(62)接合;以及
固定元件(57),其配置成当所述旋钮被转动时阻止所述旋钮(61)相对于所述套节的纵向运动。
8.如权利要求7所述的经中隔穿孔器,其中所述外管(3)相对于所述内管(2)的纵向运动促使所述外管在所述外管的蛇形地切出多个径向定向槽的节段中偏转,并且结果在所述外管的蛇形地切出多个径向定向槽的节段中产生所述外管和所述内管的选择性弯曲。
9.如权利要求7所述的经中隔穿孔器,其中在一侧横穿所述内管外侧的所述内管中的纵向定向槽(17)成一定角度地成形,从而其大致不横向地成形。
10.如权利要求7所述的经中隔穿孔器,其中所述外管的远端可以响应于所述旋钮的转动而自所述纵轴线可控地弯曲0到90度。
11.如权利要求7所述的经中隔穿孔器,其中所述内管(2)相对于所述外管(3)的轴向前进弯曲所述外管的远端。
12.如权利要求4所述的经中隔穿孔器,还包括:
从所述内管(2)的近端延伸至远端的管腔,所述内管设置在所述外管的管腔内;以及
管心针(4),其特征为具有近端、远端和设置在所述管心针的远端上的可自扩张笼(45),所述可自扩张笼具有装配到所述内管的管腔内的小直径构造和当不受约束时采用的大直径构造,所述管心针可滑动地设置在所述内管的管腔内并且可操作来将所述可自扩张笼从所述管心针的近端撤回到所述内管的管腔中并且将所述可自扩张笼从所述内管的管腔中排出。
13.如权利要求12所述的经中隔穿孔器,其中所述管心针(4)还包括管,并且所述可自扩张笼(45)包括开槽管(44、47、48),所述开槽管包括被向外偏置的多个纵向延伸的支柱(47),以当不受约束时形成径向鼓起的笼结构。
14.如权利要求12所述的经中隔穿孔器,其中所述笼(45)的直径处于大直径构造时等于或者超过所述内管的内径。
15.如权利要求12所述的经中隔穿孔器,其中所述笼(45)的直径处于大直径构造时等于或者超过所述内管的外径。
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EP2838450A4 (en) | 2015-09-02 |
US9707007B2 (en) | 2017-07-18 |
US20130274784A1 (en) | 2013-10-17 |
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