CN102029006B - 具有偏置的平面偏转特性的导管 - Google Patents
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Abstract
本发明涉及改良的可操纵导管,所述可操纵导管可进行被偏置的面内双向偏转,并且具有细长导管主体、包括管材的可偏转中间节段、以及位于所述导管主体近端上的控制手柄,所述管材具有用于牵拉线的至少第一和第二相对的轴外腔,所述管腔限定偏转平面。所述可偏转中间节段包括至少两个细长偏置构件,所述偏置构件沿着长度延伸且位于垂直于所述偏转平面的平面上,以抵抗所述偏转平面外的弯曲。在一个更详细的实施例中,所述可偏转中间节段具有一体化的管状构造,所述管状构造包括内层、围绕所述内层的编制网以及外层,其中所述偏置构件可设置在所述内层和所述编织网之间,或者设置在所述编织网和所述外层之间。
Description
技术领域
本发明涉及改良的可操纵导管,特别是可双向偏转以操纵顶端节段的导管。
背景技术
电极导管已普遍用于医疗实践多年。它们被用于刺激和标测心脏中的电活动,以及用于消融异常电活动的部位。
使用时,将电极导管插入主要的静脉或动脉(例如股动脉),然后导入所关注的心室。在心脏内,控制导管顶端的精确位置和取向的能力是至关重要的,这种能力在很大程度上决定该导管的可用性。
可操纵(或可偏转)导管是众所周知的。例如,美国专利No.Re34,502描述了具有控制手柄的导管,该控制手柄包括壳体,该壳体在其远端具有活塞室。在该活塞室中装有活塞,该活塞可进行纵向运动。导管主体的近端与该活塞附接。牵拉线附接到壳体并延伸穿过活塞和导管主体。牵拉线的远端锚定在导管的顶端节段中。以这种布置方式,活塞相对于壳体的纵向运动可导致导管顶端节段的偏转。
通常希望具有双向可操纵的导管,即能在两个方向(通常为相反方向)偏转的导管。例如,美国专利No.6,210,407公开了具有延伸穿过导管的两根牵拉线的双向可操纵导管。牵拉线的远端锚定在导管顶端节段的相对的两侧。提供合适的双向控制手柄,使每根牵拉线可以纵向移动,从而使得导管能在两个相反的方向上偏转。
另外还知道,具有顶端节段偏转机构的可操纵导管在提交于2005年2月14日,标题为STEERABLECATHETERWITHIN-PLANEDEFLECTION(具有面内偏转的可操纵导管)的美国专利申请No.11/058,102中有所描述,其全文特此以引用方式并入本文。然而,该偏转机构可被改进以用于增强管,包括通过五月柱(Maypole)或曲折的方式制成的编织管。
导管轴通常包括细长管状结构,该管状结构具有单一的、轴线或中央内腔。它们是柔性的(即可弯曲),但是沿其长度基本上不可压缩。导管轴通常具有由聚氨酯或PEBAX制成的外壁,该外壁具有不锈钢等的嵌入式编织网以增大导管轴的扭转刚度,使得一端旋转时(例如通过旋转控制手柄),轴会以相应的方式旋转,直至另一端。
编织网通常由至少两股线构成,其以相反指向的螺旋路径缠绕,这些螺旋路径以(例如)由一种细长或曲折编织的机器规定的连续间隔彼此上下交替。用于加固软管和其他管状产品以及制造绳、缆等的五月柱型编织机是已知的并已申请专利。所述专利包括美国专利No.3371573、3783736和5257571,其全文特此以引用方式并入本文。更多现代的编织机具有一种用于以交叉螺线路径引导供线载体轴(strandsupplycarrierspindles)围绕编织点的机构。该机构包括一圈载体轴驱动器,其中每个载体轴的旋转不受对其进行驱动的驱动器限制,从而使得其从以某个方向旋转的转子转移到以相反方向旋转的转子时不发生方向的突变。此外,该编织机构造使得当载体轴在其螺线路径上围绕编织点行进时,每个载体的股线放线点被基本保持在通过轴的中心和编织点画出的直线上。制造增强管的合适编织机器可购自SteegerUSA(Inman,SouthCarolina,USA)。
虽然编织且增强的管材以及用其构造的导管轴具有较好的扭转特性,其可尽量减少轴的扭结和扭曲,但仍然需要将各个层和增强构件与偏置机构相结合的管构造以促成面内偏转,即其中轴的至少一部分偏转的平面与一对牵拉线跨越的平面相同。此种导管会具有更大的对于面外偏转的抵抗力,因此能够更好地预测并更加精准地操纵导管顶端。因此,需要这样一种导管,该导管具有为面内双向偏转而偏置的一体化的管构造。
发明内容
本发明涉及改良的可操纵导管,该导管为面内双向偏转而被偏置。在一个实施例中,该导管具有细长的导管主体,可偏转的中间节段(具有至少两个通常在直径上相对的管腔,各有一根牵拉线),以及位于导管主体近端的控制手柄。根据本发明的特征,该中间节段具有包括至少两个偏置构件的一体化的管构造,所述偏置构件以大致相对的位置沿着中间节段的长度延伸,在二者之间限定跨越中间节段的横向轴线(或直径)。有利地是,在这两个偏置构件的作用下,中间节段呈现相对于一对牵拉线的更加平面的偏转,其中中间节段通过控制手柄经牵拉线而发生偏转。因此,在组织标测和消融期间,能够对位于中间节段远侧并承载顶端消融电极和/或感测环电极的顶端节段进行更加精确的控制和操纵。
在一个更详细的实施例中,一体化的管状构造包括内层、围绕内层的编织网以及外层,其中偏置构件一体化于内层和编织网之间或编织网和外层之间。在另一个更详细的实施例中,偏置构件为由金属、合金、不锈钢、镍钛诺、陶瓷、碳、塑料和/或它们的组合构造成的线材。
在另一个实施例中,导管包括具有适于组织消融的顶端电极的远端节段。所述导管也可包括用于标测的环电极、用于顶端节段定位的电磁定位传感器和/或用于感测顶端温度的热电偶线。顶端节段还可适于用流体冲洗,流体通过沿着导管延伸的冲洗管将流体递送到顶端电极。
附图说明
通过参考以下与附图结合考虑的详细说明,将更好地理解本发明的这些和其他特征以及优点,其中:
图1为根据本发明的导管实施例的侧视图。
图2A为沿图1所示导管的第一直径截取的导管主体与可偏转中间节段的接合处的侧向剖面图。
图2B为沿大致垂直于第一直径的第二直径截取的图2A所示接合处的侧向剖面图。
图3A为一体化的管状构造的实施例的部分剖切等轴视图,该构造为面内双向偏转而被偏置。
图3B为一体化的管状构造的替代实施例的部分剖切等轴视图,该构造为面内双向偏转而被偏置。
图4为沿着线4--4截取的图2A和2B所示可偏转的中间节段的纵向剖面图。
图5为与偏转的管节段有关的牵拉线的取向的示意性等轴视图,示出根据本发明特征的面内偏转。
图6A为沿图1所示导管的第一直径截取的可偏转中间节段与连接管的接合处的侧向剖面图。
图6B为沿第二直径截取的图5A所示接合处的侧向剖面图。
图7为沿第二直径截取的图1所示的导管顶端节段的侧向剖面图。
具体实施方式
根据本发明的特征,提供具有标测和/或消融功能的可控电极导管,其中所述导管的至少一个节段为面内双向偏转而被偏置。如图1的实施例所示,导管10包括细长导管主体12、从导管主体12的远端伸出的可偏转的中间节段14以及从中间节段14的远端延伸的顶端节段18。在导管主体12的近端设有控制手柄16。适用于本发明的控制手柄的实例描述于美国专利No.5897529、6913594和7377906,其全文以引用方式并入本文。在示例性实施例中,控制手柄16具有偏转旋钮17,操作者可用该旋钮通过中间节段14的双向面内偏转来操纵顶端节段18。
参照图2A和2B,导管主体12包括具有单个中央腔或轴上腔19的细长管状构造。导管主体12是柔性的(即可弯曲),但沿其长度基本上是不可压缩的。导管主体12可为任何合适的结构,并且可由任何合适的材料制成。目前优选的结构包括由聚氨酯或尼龙制成的外壁22。外壁22包括由不锈钢或类似材料(未示出)制成的嵌入式编织网,以增大导管主体12的扭转刚度,使得当旋转控制手柄16时导管10的顶端节段会以相应的方式旋转。
导管主体12的外径不是决定性的,但优选不大于约8弗伦奇(French)。同样,外壁22的厚度也不是决定性的。外壁22的内表面衬有加劲管20,其可由任何合适的材料(优选聚酰亚胺)制成。加劲管连同编织外壁22能提供改善的扭转稳定性,同时使导管的壁厚最小化,因而使该单管腔的直径最大化。加劲管20的外径与外壁22的内径相比大致相同或稍小。聚酰亚胺管为优选材料,因为它可以制成非常薄的壁而仍然达到很好的刚度。这使中央腔19的直径最大化而不伤及强度和刚度。聚酰亚胺材料通常不用于加劲管,因为其在弯曲时有扭结的趋势。然而,已经发现,与聚氨酯、尼龙或其他类似材料的外壁22(特别是具有不锈钢编织网)相结合,就所述导管所用的应用而言,聚酰亚胺加劲管20在弯曲时扭结的趋势基本得到消除。
在一个实施例中,导管外壁22的外径为约0.092英寸、内径为约0.063英寸,聚酰亚胺加劲管的外径为约0.0615英寸、内径为约0.052英寸。
在一个实施例中,通过速干胶(如氰基丙烯酸酯)在加劲管20和外壁22之间形成第一胶接处23。其后用较慢干燥但较强力的胶(如聚氨酯)在加劲管20的近端和外壁22之间形成第二胶接处26。
如图2A和2B所示,可偏转的中间节段14从导管主体12的远端伸出。中间节段14构造为具有多个轴外腔30、31、32和33(如下详细描述),用来承载各种部件(包括两根牵拉线42)以实现偏转。其他部件包括引线40、热电偶线41和45、传感器电缆36和冲洗管37。
另外参考图3A,中间节段14的一个实施例具有一体化的管构造51,该管构造具有内层50、强化或编织网52、一对偏置构件54和外壁56。在一个详细的实施例中,内层50包括可熔融挤出的聚合物材料(如尼龙或聚酰亚胺),并且外壁56包括可熔融挤出的聚合物材料(如尼龙、聚氨酯或PEBAX)。两种材料都优选使用已知的熔融或浆料挤压技术挤出。内层50的壁厚介于约0.001和0.080英寸之间,优选介于约0.003和0.040英寸之间,更优选介于约0.006和0.022英寸之间。外壁56的壁厚介于约0.001和0.050英寸之间,优选介于约0.003和0.035英寸之间,更优选介于约0.005和0.015英寸之间。
通过使用本领域熟知的编织机可以将编织网52施加在内层50上。编织机包括多个线轴,线轴上装载被织造或编织的股线或纤维。纤维通过编织机送入编织区,在该区域中将纤维编织或缠绕在内层50周围。作为另外一种选择,编织网52也可构造成预制的、类似袜子的样式,然后安装到内层50上。编织网的股线或纤维可以是由金属、塑料、陶瓷或玻璃制成的扁平线或片状线,这些材料是柔性的,并且即便不具有形状记忆性和/或超弹性特性,但也至少具有高弹性模量。在一个详细的实施例中,该材料在屈服之前应具有高百分比的应变。一些合适的材料包括不锈钢、镍钛诺和亚稳态钛钼基合金,以及它们的组合。其他合适的材料包括硼陶瓷纤维、碳纤维和玻璃纤维。合适的塑料包括芳纶纤维、聚酯纤维、液晶聚合物纤维,例如KEVLAR、NOMEX、DACRON、SPECTRA和VECTRAN。
在一个实施例中,编织网52包括交织螺线构件,通常为12、16或24个交织螺线构件,其一半以一个方向延伸而另一半以相反方向延伸。与导管的轴线平行并与螺旋构件交叉的线相对于螺旋构件的紧密度或编织角不是决定性的,但该角度优选约45度。
在图3A和图4所示的实施例中,具有两个细长偏置构件或线材54,每个偏置构件置于中间节段14的相对侧并沿着内层50与编织网52之间的节段14的长度延伸。偏置构件54彼此相对地跨越管构造的直径,并限定沿中间节段14的纵向轴线布置的横向轴线或平面100,其重要性在下文中将详细讨论。偏置构件54可以为线材,该线材由具有或不具有形状记忆性(如镍钛诺)的不锈钢制成,并且也可以由任何其他合适的材料(例如用于编织网52的那些材料)制成。其他合适的材料包括陶瓷、碳纤维、金属元件、合金、塑料或它们的组合。
内层50上外壁56的挤出物、偏置构件54和编织网52将偏置构件54和编织网52一体化或以其他方式结合到内层50上。也就是说,当挤出时,挤出而形成外壁56的材料熔融并流入编织网52和偏置构件54的间隙或空隙中,并且使它们整体地形成在内层50上,以得到层状的但一体化的构造。因此,编织网52、偏置构件54和内层50之间的相对运动即使存在也是最小的,以提供沿着中间节段14的改良的弯曲和扭转稳定性。具体地讲,一体化的偏置构件54的大致正对的布置阻止管构造在平面100内弯曲,因而使管构造偏移成在与平面100垂直的平面内弯曲。
在本发明所公开的实施例中,成对偏置构件54中每个构件的横截面的形状和尺寸基本相同,以实现对称偏置。示出的横截面形状是圆形的,但是理应知道该形状可以为任何合适的形状,包括三角形、矩形或任何其他多边形。还应当理解,各对偏置构件的横截面并不需要具有彼此相同的尺寸或形状。此外,可使用两个以上的偏置构件并且其布置可以是非对称的,例如两个较弱的偏置构件位于一侧而一个较强的偏置构件位于另一侧,以致其整体效果或组合效果是平衡的或有意地成为非平衡。此外,偏置构件不需要沿着受影响导管的长度直线延伸,即偏置构件可以有起伏或具有钝角或锐角以使得导管具有非线性偏转特性。应当理解,根据导管轴的应用,偏置构件的数量、形状和/或尺寸可因不同的偏转特性而不同,包括螺线形或螺旋形偏转构造。
在图3A和图4所示的实施例中,内层50提供多个轴外腔,包括管腔30、31、32和33。如图4所示,第二管腔31分别带有引线40T和40R,分别用于顶端电极46和环电极48,电磁定位感应器38的热电偶线41和45以及电缆36置于顶端节段18中。第四管腔33带有冲洗管37以沿着导管输送流体,包括输送到顶端节段18中的流体。
根据本发明的特征,第一管腔30和第三管腔32专用于承载牵拉构件或线42,因为平面102(其中这些管腔有意地与横向平面100垂直)由偏置构件54限定。偏置构件54可以抵抗中间节段14在平面100内弯曲,当通过牵拉线42偏转时,中间节段14被偏置成可在平面102内展现更平的移动,从而促成“面内”偏转,即在由管腔30和32以及牵拉线42所限定的平面内偏转。
由于中间节段14被如此构造,操作者可操作控制手柄16使牵拉线42移动,这为中间节段14的更可预测的双向偏转以及进而在消融和/或标测期间更精确的地控制和操纵顶端节段18创造了条件。应当理解,管腔的精确尺寸不是决定性的,它取决于管腔所装载部件的尺寸。
图2A和图2B中示出了将导管主体12附接到中间节段14上的方式。中间节段14的近端包括接纳导管主体12的外壁22的内表面的外周凹口34,其位于内层50和外层56之间。该结合处可用胶或类似物35固定。
如果需要,可在导管主体内增强管22(如果提供)的远端与中间节段14的近端之间设置间隔区(未示出)。该间隔区使导管主体12和中间节段14的接合处形成柔韧过渡区,其使此接合处平滑地弯曲而不会折叠或扭结。具有此类间隔区的导管在美国专利No.5,964,757中有所描述,该专利的公开内容以引用方式并入本文。
在该中间节段14的远端为通过连接管43连接到中间节段的顶端节段18。在图6a和6b所示的实施例中,连接管43具有让引线40T和40R、热电偶线41和45、电磁感应电缆36以及中间节段14到顶端节段18的冲洗管37通过的单个管腔47。单个管腔47使这些部件能够从中间节段14中的各个管腔朝它们在顶端节段18中的位置重新定向。如图所示,各种部件可彼此交叉,以将它们适当对准而进入顶端节段18。
图6A和图6B中示出了将中间节段14附接到连接管43上的方式。连接管43的近端包括接纳管构造51的内表面的外周凹口90,其位于外层56和内层50之间。该结合处可用胶或类似物92固定。
如图7所示的顶端电极46具有远端57,其构造为无损伤样式,以便与组织接触并根据需要用于组织消融。连接管43的远端接纳的顶端电极的环状近端59具有近侧表面,该近侧表面中的盲孔60、62和64构造成分别接纳使顶端电极带电的引线40T的远端、用于感测顶端电极处的温度的热电偶线41和45的远端、以及电磁感应器38的远端。如本领域周知,这些远端锚定在盲孔中。流体通道70形成于顶端电极中,沿其纵向轴线延伸。流体通道的近端接纳适于将流体输送到流体通道70中的冲洗管37的远端。设有横向分支72以让流体经过端口74流出顶端电极,以(例如)冲洗并冷却顶端电极46和/或消融组织位点。在接近顶端电极46处,一个或多个环电极48(用于标测的单极或双极)安装到连接管43上,每个电极具有各自的引线40R。
环电极48连接到引线40R上,并且顶端电极46连接到引线40T上。引线40从邻近顶端节段18延伸穿过连接管43的管腔47、中间节段14的管腔31、导管主体12的中央腔19和控制手柄16,并在其位于连接器90中的近端终止,以将信号传送到合适的信号处理单元(未示出)并且电极可连接到消融能量源(未示出),包括射频。延伸穿过导管主体12的中央腔19和第二管腔31的近端的引线部分可封装在保护鞘管(未示出)内,该保护鞘管可用任何合适的材料(优选聚酰亚胺)制成。用聚氨酯胶等材料将保护鞘管粘附在管腔31中,保护鞘管的远端固定于中间节段14的近端。
可以用任何合适的方法将每条引线40R连接到其对应的环电极上。将引线连接到环电极48上的优选方法需要首先开出一个穿过连接管43的管壁的小孔。例如,可通过将足以形成永久性孔的针头穿过不导电包覆层来形成这样的孔。然后使用微型钩或类似物拉动引线穿过此孔。剥去导线末端的任何涂层并将末端焊接在环电极的下侧,然后将环电极滑动到孔上方并用聚氨酯胶等将其固定到位。或者,可通过在不导电包覆层周围多次缠绕导线并且剥去导线外表层的自身绝缘层来形成每个环电极。或者,也可用导电材料(如铂、金和/或铱)涂覆管材来形成环电极。可采用溅射、离子束淀积或等同技术来涂敷涂层。
热电偶线41和45从锚定在顶端电极46中的其远端延伸,并穿过连接管43的单个管腔47,穿过中间节段14的第二管腔31,穿过导管主体12的中央腔19,并进入控制手柄16,然后其近端在连接器90中的控制手柄16的近端处终止。
电磁定位传感器38的电缆36向近侧延伸穿过连接管43的管腔47,穿过中间节段14的第二管腔31,穿过导管主体12的中央腔19,并进入控制手柄16中。电磁传感器电缆36具有包裹在塑料覆盖外皮中的多条导线。在控制手柄16中,传感器电缆36连接到电路板(未示出)。电路板将从电磁传感器接收到的信号放大,并将它以计算机能可识别的形式传送到计算机。用于本发明的合适的电磁传感器在以下专利中有所描述:例如美国专利申请序列号09/160,063(标题为“MiniaturizedPositionSensor”(微型定位传感器))以及美国专利No.5,558,091、5,443,489、5,480,422、5,546,951、5,568,809和5,391,199,这些专利的公开内容以引用方式并入本文。
冲洗管37从顶端电极46穿过连接管43的管腔47、穿过中间节段14的第四管腔33、穿过导管主体12的中央腔19并穿过控制手柄16向近侧延伸。生理盐水或其他合适的流体可通过位于控制手柄16的近端处的鲁尔接头21等注入冲洗管37中。鲁尔接头21连接于柔性塑料管24,例如用聚酰亚胺制成的塑料管。如图1所示,塑料管24附接在冲洗管的近端,优选位于手柄16内。作为另外一种选择,塑料管24可连接到吸引源(未示出),以从被消融的区域中抽吸流体。
如图2A和图6A所示,每根牵拉线42从控制手柄16延伸穿过导管主体12中的中央腔19,并进入中间节段14中内层50的第一管腔30和第三管腔32中的不同管腔。牵拉线42用任何合适的材料(例如不锈钢或镍钛诺)制成。优选的是,每根牵拉线具有涂层,例如Teflon.RTM.或类似材料的涂层。每根牵拉线的直径优选在约0.006英寸至约0.0010英寸的范围内。两根牵拉线具有相同的直径。
每根牵拉线42的近端锚定在控制手柄16中,以便操作控制器(例如偏转旋钮17)来移动牵拉线,从而使中间节段14偏转。就此而言,每根牵拉线的远端通过T型杆锚锚定在位于或接近中间节段14的远端的侧壁中,该T型杆锚由金属管80构成,例如皮下管的一小段,其通过(例如)卷边固定地附接到牵拉线的远端,并且横挡81以横向布置方式焊接或熔接到管80的扁平远端。T型杆锚描述于美国专利No.6,267,746和6,064,908中,其全文特此以引用方式并入本文。其他在中间节段14中锚定牵拉线42的方法当为本领域技术人员所明白,并涵盖在本发明范围之内,其中包括将远端锚定在顶端电极46的近端上的盲孔中。
如图2A和图2B所示,所公开的导管10的实施例还包括两个压缩线圈49,每个线圈围绕导管主体12中对应的牵拉线42。在图示实施例中,每个压缩线圈都由任何合适的金属(例如不锈钢)制成,并且其自身紧密缠绕以提供柔韧性即弯曲性,但抗压缩。每个压缩线圈的内径略大于与其相关的牵拉线42的直径。例如,当牵拉线42的直径为约0.007英寸时,对应的压缩线圈49优选具有约0.008英寸的内径。牵拉线42上的涂层使得它们能在压缩线圈49内自由滑动。每个压缩线圈49的外表面用柔韧的非导电外皮61沿其大部分长度覆盖,以防压缩线圈49与中央腔19中的引线40接触。在一个实施例中,非导电外皮61由薄壁聚酰亚胺管制成。
压缩线圈49用聚氨酯胶或类似物固定于导管主体12内。每个压缩线圈49的近端通过胶接(未示出)锚定于导管主体12中的加劲管22的近端。在图2A示出的实施例中,压缩线圈49的远端伸入中间节段14的管腔30和32内,并且其远端通过胶接处51锚定于中间节段的近端。作为另外一种选择,在不使用加劲管22的情况下,每个压缩线圈的近端和远端可直接锚定于导管主体12的外壁20上。
图2A和6A的实施例中,在轴外腔30和32中,每根牵拉线42被塑料外皮82围绕,所述外皮优选由Teflon.RTM.制成。偏转时,塑料外皮82防止牵拉线切入中间节段14的内层50。每个外皮82的全长通常为中间节段14的长度。作为另外一种选择,每根牵拉线42可用其中各圈在纵向扩张的压缩线圈围绕,与穿过导管主体延伸的上述压缩线圈相比,这种围绕的压缩线圈既可以弯曲,也可以压缩。
在一详述的实施例中,牵拉线42相对于导管主体12的纵向移动可通过控制手柄16的适当操纵来实现,从而使顶端节段14在该牵拉线延伸所至的中间节段的侧边方向上偏转。用于本发明的其他合适的双向控制手柄在以下专利中有所描述:2001年3月30日提交的标题为“SteerableCatheterwithaControlHahdleHavingaPulleyStructure”(带具有滑轮结构的控制手柄的可操纵导管)的专利申请SerialNo.09/822,087,以及美国专利No.6123699、6171277、6198974和7377906,其全文以引用方式并入本文。
如图4的实施例所示,带有牵拉线42的管腔30和32置于平面102上,该平面基本垂直于两个偏置构件54所在的横向平面100。因此,通过牵拉线42的纵向移动所实现的中间节段14的偏转大致为平面的,因为中间节段14(以及顶端18)基本都处于平面102中。
参照图3B,在一体化的管构造51的替代实施例中,偏置构件54可位于编织网52之外,以使得偏置构件一体化于外壁56和编织网52之间。由于外壁56被挤出,形成外壁的材料熔融并流入编织网52和偏置构件54的间隙或空隙中,并且将它们一体地形成到内层50上。
如另一个替代实施例所示,内层50不必提供多个管腔,但可以根据需要仅形成有中央腔,如图3B所示,例如对于导管主体或导管10的任何节段而言,包括可偏转中间节段,其中部件延伸穿过中间节段,或者可经过用胶等可靠固定在中央腔中的独立管材63,所述部件包括浮置在中央腔中的牵拉线42。
编织网52、偏置构件54和内层50之间的相对移动即使存在也是最小的,以使得管构造具有更平面的偏转特性,还具有弯曲和扭转稳定性的所有有益效果。还应该知道,大多数导管管材可与本发明的偏置构件一起改进。外层在偏置构件上的挤出充分地将偏置构件一体化到已存在的导管管材中,以达成偏置的面内双向偏转。
已结合本发明的当前的优选实施例进行了以上描述。本发明所属技术领域内的技术人员将会知道,在不有意背离本发明的原则、精神和范围的前提下,可对所述结构作出更改和修改。本领域内的普通技术人员将了解,附图未必按比例绘制。因此,以上描述不应视为仅与所描述的和附图所示的精确结构有关,而应视为符合所附的具有最全面和合理范围的权利要求书,并作为权利要求书的支持。
Claims (24)
1.一种可操纵导管,所述可操纵导管包括:
细长导管主体;
可偏转中间节段,所述中间节段包括具有至少两个轴外管腔的一体化的管构造,所述轴外管腔限定偏转平面,所述可偏转中间节段还包括至少两个偏置构件,所述偏置构件在相对位置上沿所述中间节段纵向地且非直线地延伸,限定大致垂直于所述偏转平面的横向轴线,
第一牵拉线和第二牵拉线,所述第一牵拉线延伸穿过所述至少两个轴外管腔的第一管腔,并且所述第二牵拉线延伸穿过所述至少两个轴外管腔的第二管腔,
控制手柄,所述控制手柄位于所述导管主体的近端,适于操作者操纵牵拉线的移动,以将所述中间节段偏转,
其中所述中间节段由所述偏置构件偏置,以大致保持在所述偏转平面内。
2.根据权利要求1所述的导管,其中所述可偏转中间节段还包括管状构造,所述管状构造包括内层、围绕所述内层的编织网以及外层,其中所述偏置构件一体化于所述内层和所述编织网之间。
3.根据权利要求1所述的导管,其中所述可偏转中间节段还包括管状构造,所述管状构造包括内层、围绕所述内层的编织网以及外层,其中所述偏置构件一体化于所述编织网和所述外层之间。
4.根据权利要求2所述的导管,其中所述内层形成为具有所述至少两个轴外管腔。
5.根据权利要求4所述的导管,其中所述内层形成为具有至少三个管腔。
6.根据权利要求3所述的导管,其中所述内层形成为具有所述至少两个轴外管腔。
7.根据权利要求3所述的导管,其中所述内层形成为具有至少三个管腔。
8.根据权利要求1所述的导管,还包括位于所述中间节段远侧的顶端节段。
9.根据权利要求1所述的导管,其中所述偏置构件由选自以下各项的材料制成:金属、陶瓷、碳、塑料、以及它们的组合。
10.根据权利要求9所述的导管,其中所述金属包括合金。
11.根据权利要求10所述的导管,其中所述合金包括不锈钢、镍钛诺。
12.一种导管,所述导管包括:
细长的柔性管状导管主体,所述导管主体具有近端和远端以及延伸穿过其中的管腔;
可偏转中间节段,所述可偏转中间节段位于所述导管主体的远端,并且包括柔性的一体化管构造,所述管构造具有至少一对在直径上相对的管腔,所述管腔限定第一平面;
顶端节段,所述顶端节段位于所述中间节段的远端;
控制手柄,所述控制手柄位于所述导管主体的近端;
第一牵拉线和第二牵拉线,每根牵拉线延伸穿过所述中间节段的不同管腔并穿过所述导管主体的所述管腔,每根牵拉线的近端锚定于所述控制手柄,而其远端锚定在位于或接近所述中间节段的远端的位置,从而所述第一牵拉线和第二牵拉线能够相对于所述导管主体发生纵向移动,致使所述中间节段偏转;以及
两个细长的偏置构件,每个偏置构件沿所述中间节段非直线地延伸,所述两个偏置构件限定与所述第一平面垂直的第二平面,
其中所述偏置构件将所述中间节段偏置,以在通过所述牵拉线进行偏转时保持所述第一平面和第二平面之间的垂直关系。
13.根据权利要求12所述的导管,其中所述一体化管构造包括内层、编织网和外层,其中所述偏置构件位于所述内层和所述编织网之间。
14.根据权利要求12所述的导管,其中所述一体化管构造包括内层、编织网和外层,其中所述偏置构件位于所述编织网和所述外层之间。
15.根据权利要求12所述的导管,其中所述偏置构件由选自以下各项的材料制成:金属、陶瓷、碳、塑料、以及它们的组合。
16.根据权利要求15所述的导管,其中所述金属包括合金。
17.根据权利要求16所述的导管,其中所述合金包括不锈钢、镍钛诺。
18.根据权利要求14所述的导管,其中所述外层是挤出的。
19.根据权利要求13所述的导管,其中所述外层是挤出的。
20.根据权利要求12所述的导管,其中所述顶端节段包括适于组织消融的顶端电极。
21.根据权利要求12所述的导管,其中所述顶端节段包括至少一个适于标测的环电极。
22.根据权利要求20所述的导管,其中所述顶端电极适于流体冲洗。
23.一种导管,所述导管包括:
细长导管主体,
可偏转节段,所述可偏转节段位于所述导管主体远侧,并且包括内层和外层,以及位于所述内层和所述外层之间的编织网,所述可偏转节段还具有至少两个一体化于所述内层和所述外层之间的细长偏置构件,所述偏置构件沿所述可偏转节段的相对位置非直线地延伸且位于一平面上;
至少一根牵拉线,所述牵拉线延伸穿过所述导管主体和所述可偏转节段;
位于所述导管主体远侧的顶端节段,所述顶端节段适于组织消融;以及
位于所述导管主体近端的控制手柄,所述控制手柄适于操作者通过所述牵拉线操纵所述可偏转节段的偏转,
其中当所述可偏转节段偏转时,所述偏置构件抵抗所述平面内的弯曲。
24.一种导管,所述导管包括:
细长导管主体,
可偏转节段,所述可偏转节段位于所述导管主体远侧,并且包括内层、外层和中央腔,以及位于所述内层和所述外层之间的编织网,所述可偏转节段还具有至少两个一体化于所述内层和所述外层之间的细长偏置构件,所述偏置构件沿所述可偏转节段的相对位置非直线地延伸且位于一平面上;
至少一个管材,所述管材延伸穿过所述可偏转节段的所述中央腔,所述管材固定地附接在限定所述中央腔的内壁上;
至少一个牵拉构件,所述牵拉构件延伸穿过所述管材;
位于所述导管主体远侧的顶端节段,所述顶端节段适于组织消融;以及
位于所述导管主体近端的控制手柄,所述控制手柄适于操作者通过所述牵拉构件操纵所述可偏转节段的偏转,
其中当所述可偏转节段被偏转时,所述偏置构件抵抗在其平面内的弯曲。
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US12/569,779 US9101733B2 (en) | 2009-09-29 | 2009-09-29 | Catheter with biased planar deflection |
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CN102029006A (zh) | 2011-04-27 |
AU2010219388B2 (en) | 2015-07-09 |
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