CN107007921B - 导管的贯通顶端 - Google Patents
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Abstract
导管(110)具有细长管状轴(111),细长管状轴(111)包括限定在其中的膨胀腔(112)和导丝腔(113),导丝腔(113)至少沿细长管状轴的内管状构件(118)的远侧长度延伸。导管包括具有近端和远端的远端构件(127),其中,远端构件是整体的并且远端构件的近端被固定到内管状构件的远端。导管包括具有近侧部分和远侧部分的球囊(114),球囊的近侧部分密封地联接到细长管状轴的远侧部分。球囊的远侧部分密封地联接到远端构件并且球囊限定与膨胀腔连通的内室(141),其中,远端构件的近端被设置在内室中。
Description
相关申请的交叉引用
本申请要求于2011年5月26日提交的名称为“Through Tip For A Catheter”的美国临时专利申请序列号61/490,444的权益,该临时专利申请的全部内容以参考的方式并入本文中。
技术领域
本文中公开的主题一般地涉及医疗装置,并且具体地涉及一种用于治疗或诊断用途的体内装置(例如球囊导管)的远端构造。
背景技术
在经皮冠状动脉血管成形术(PTCA)中,使导向导管在患者的脉管***中行进,直到导向导管的远端固定在期望的冠状动脉中。使导丝从导向导管的远端行进入冠状动脉中,直到导丝的远端穿过被扩张的病变部位。在其远侧部分具有可膨胀球囊的扩张导管在以前所导入的导丝上行进到冠状动脉解剖结构中,直到将扩张导管的球囊定位在病变部位。一旦定位,则用膨胀流体在适当的压力下使扩张球囊一次或多次膨胀使其达到预定的尺寸,以挤压动脉壁的狭窄部位从而打开血管通道。通常,球囊的扩张直径是与被扩张体腔的原来直径大致相同的直径,从而完成扩张但不过分扩张动脉壁。在使球囊萎陷之后,血液恢复流经扩张的动脉并且可以从动脉中去除扩张导管和导丝。
在这种血管成形术中,可能会存在动脉的再狭窄,即动脉阻塞的再形成,因此必须执行另一次血管成形术、或者用于修复或加强扩张区域的一些其它方法。为了降低再狭窄的发生率并且加强扩张区域,医生此外或可替代地会在病变部位将血管内假体植入动脉内部。这种支架可以是裸露的金属、聚合材料,或者用药物或其它治疗剂涂覆。还可利用支架来修复具有内膜拍动或剥离的血管或者通常强化血管的弱化的部分。通常在收缩状态下将位于导管球囊上的支架传递至管状动脉内的期望位置,这在许多方面类似于球囊血管成形术导管,并且利用球囊的扩张使支架扩张到较大直径。通过使球囊萎陷而去除在扩张的病变部位植入动脉中的带支架的导管。支架的内或外表面上的覆盖物已被应用于例如假性动脉瘤和动脉穿孔的治疗,并且用于防止斑块脱垂。类似地,包括由组织或合成材料(例如聚酯、膨体聚四氟乙烯和涤纶织物(DACRON))所制成的圆柱形管的血管移植物可以被植入血管以加强或修复血管、或者用于吻合术以便将各血管段连接到一起。为获得示例性支架的详细情况,可参见例如美国专利第5,507,768号(Lau等人)和美国专利第5,458,615号(Klemm等人),这些专利文件的内容以参考的方式并入本文中。
除了PTA、PTCA和斑块旋切术之外,球囊导管还可应用于外周***(例如静脉***等)中。例如,最初使球囊导管在导丝上行进以便将球囊定位在与狭窄病变部位相邻的位置。一旦固定就位,则使球囊膨胀,并且打开对血管的限制。同样地,球囊导管也可用于对体内的其它内腔***的治疗。
通常,球囊导管包括具有固定在远端的球囊的空心导管轴。球囊的内部与沿导管轴的长度延伸的膨胀腔处于流体流动的关系。由此,可以在压力下将流体经过膨胀腔提供至球囊的内部。为了将球囊定位在变窄区域,而将导管轴设计成具有适当的推送性(即,沿导管的长度传递力的能力)、可跟踪性和柔性,以便可容易地在脉管***的曲折解剖结构内行进。用于血管内手术(例如血管成形术和支架传递)的常规球囊导管常常具有相对较硬的近侧轴部(以便于导管在体腔内的行进)和相对较柔性的远侧轴部(以便于在不对血管壁造成损伤的情况下通过曲折的解剖结构(例如远侧冠状动脉和神经动脉))。
传统的导管轴通常具有内和外构件管,在内和外构件管之间具有用于球囊膨胀的环形空间。在导管轴的设计中,理想的是预先确定或控制其特性(例如导管轴各种部分的强度、刚度和柔性)从而提供期望的导管性能。这通常是通过将不同材料和/或尺寸的单独长度的管状构件加以组合然后将单独的构件组装成单个轴长度。然而,在不同刚度或材料的部分之间的过渡可以是沿导管长度的不良扭折的一个原因。这种扭折在快速交换(RX)型导管中特别明显,其中远侧轴部不包括其它结构的导丝腔管。例如,常规的RX导管通常由近侧海波管和远端部处的双腔或同轴管构造构成,海波管具有穿过其中的单个膨胀腔,双腔或同轴管构造在其内具有导丝腔和膨胀腔。使在更刚性近侧部分和更柔性远侧部分之间的过渡处的扭折最小化的已知技术包括:将不同柔性的两个以上段结合到一起而形成轴。这种过渡结合需足够地牢固,以承受使用期间作用于轴的推力和拉力。
为了解决上述问题,已开发出了具有变化的柔性和/或刚度的导管,该导管具有特别定制以提供期望的导管性能的各种部分的导管轴。例如,授予Maguire的美国专利第4,782,834号和授予Burns的美国专利第5,370,655号公开了一种具有沿其长度的由具有不同刚度的材料形成的各段的导管;授予Solar的美国专利第4,976,690号公开了一种具有中间腰部的导管,该中间腰部提供沿导管轴的增加的柔性;授予Cornelius的美国专利第5,423,754号公开了一种由于导管轴中的材料和尺寸过渡因而在其远侧部分具有更大柔性的导管;授予Cornelius的美国专利第5,649,909号公开了一种具有近侧部分的导管,该导管由于涂覆有聚合物涂层因而具有更大刚度;和授予Haslinger美国专利公开第2010/0130925号公开了一种采用减小扭折的高邵氏D硬度值材料与较低邵氏D硬度值材料的组合的多层导管轴。
特别令人感兴趣的是医疗装置或导管的远侧段或顶端的构造和结合。经常理想的是为远端提供减小的剖面轮廓以及通常为非创伤性或柔软的构造,同时仍然维持在远端构件(远侧顶端构件)与远端构件所附接的球囊和/或内管状构件之间的结合的充分强度。
因此,对于包括具有改善的特性组合(例如强度、弹性和制造的容易性)的导管轴的导管存在着需求。本文中公开的主题满足了这些需要和其它需要。
发明内容
基于下面的描述,本文中所公开主题的目的和优点将得以陈述和理解,并且将通过对所公开主题的实施而得以认知。通过在书面描述及其权利要求以及附图中所特别指出的方法和***,将认识和获得本文所公开主题的其它优点。
为了实现上述优点和其它的优点并且根据所公开主题的目的,正如实施例中的广泛描述,根据一个实施例,所公开的主题包括导管,该导管包括具有近侧部分和远侧部分的细长管状轴,该细长管状轴包括内管状构件,内管状构件具有从管状轴的远侧部分向远侧延伸的远侧长度。细长管状轴具有限定在其中的膨胀腔和导丝腔,导丝腔至少沿内管状构件的远侧长度延伸。导管还包括具有近端和远端的远端构件,其中远端构件是整体的并且远端构件的近端被固定到内管状构件的远端,远端构件具有与内管状构件的导丝腔相连通的导丝腔。该导管还包括具有近侧部分、远侧部分和在其间的工作长度的球囊,球囊的近侧部分密封地联接到细长管状轴的远侧部分。球囊的远侧部分密封地联接到远端构件并且球囊限定与膨胀腔流体连通的内室,其中远端构件的近端被设置在内室中。
根据所公开主题的另一方面,公开了一种制作球囊导管的方法。该方法包括:提供一种具有近侧部分和远侧部分的细长管状轴,该细长管状轴包括内管状构件,内管状构件具有从细长管状轴的远侧部分向远侧延伸的远侧长度,细长管状轴具有限定在其中的膨胀腔和导丝腔,导丝腔至少沿内管状构件的远侧长度延伸。该方法还包括:提供远端构件,其中远端构件是整体的并且包括近端和远端,远端构件具有限定成穿过其中的导丝腔。远端构件被固定到内管状构件的远端,使得远端构件的导丝腔与内管状构件的导丝腔连通。提供一种具有近侧部分、远侧部分和在其间的工作长度的球囊,球囊在其中限定内室。该方法还包括:将球囊的近侧部分联接到细长管状轴的远侧部分,使得球囊的内室与膨胀腔流体连通;以及将球囊的远侧部分联接到远端构件,使得远端构件的近端设置在球囊的内部。
在所公开主题的另一个实施例中,公开了一种部署球囊导管的方法。该方法包括提供导管,该导管包括具有近侧部分和远侧部分的细长管状轴,细长管状轴包括内管状构件,内管状构件具有从细长管状轴的远侧部分向远侧延伸的远侧长度。细长管状轴具有限定在其中的膨胀腔和导丝腔,该导丝腔至少沿内管状构件的远侧长度延伸。导管还包括具有近端和远端的远端构件,其中远端构件是整体的并且远端构件的近端被固定到内管状构件的远端。远端构件具有与内管状构件的导丝腔连通的导丝腔,并且球囊具有近侧部分、远侧部分以及在其间的工作长度。球囊的近侧部分密封地联接到细长管状轴的远侧部分,球囊的远侧部分密封地联接到远端构件。球囊限定与膨胀腔流体连通的内室,其中将远端构件的近端设置在内室中。该方法还包括:将导管的球囊定位在体腔内部;以及通过经过细长管状轴的膨胀腔导入加压流体而使球囊膨胀。
应该理解的是,前面的概述和下面的详细说明均为实施例,并且意图是提供对要求专利保护的本公开主题的进一步解释。包括在本说明书中且构成其一部分的附图,是用来说明并提供对所公开主题的***和方法的进一步理解。连同说明,这些附图的目的是用来解释所公开主题的原理。
附图说明
从下面的详细说明并结合附图将更容易地理解本申请的主题,在附图中:
图1是使所公开主题的特征具体化的球囊导管的局部剖切示意性侧视图,该球囊导管具有连接到位于球囊内部的内管状构件的远端构件和单个中心标志带。
图2A是使所公开主题的特征具体化的球囊导管的局部剖切示意性侧视图,该球囊导管具有远端构件,该远端构件从远端构件的近端到远端构件的远端形成锥形。
图2B是使所公开主题的特征具体化的球囊导管的局部剖切示意性侧视图,该球囊导管具有远端构件,该远端构件向球囊的远端的远侧形成锥形。
图3是沿线3-3所截取的图1的导管的横向剖视图。
图4是沿线4-4所截取的图1的导管的横向剖视图。
图5A和图5B分别是以在根据所公开主题的一个实施例的导管的示意图与常规导管进行比较为目的的视图。
图6A和图6B分别是图5A和图5B的导管的远侧视图。
图7是部分地在使所公开主题的特征具体化的穿丝(over the wire)型球囊导管的剖面中的示意性侧视图;该穿丝型球囊导管具有连接到位于球囊内部的内管状构件的远端构件和两个标志带。
具体实施方式
现在将详细地参考所公开主题的实施例、在附图中图解说明的实例。这些实例并非意图以任何方式限制所公开主题的范围。将结合对本发明***的详细说明来描述本文中公开的主题。
根据所公开的主题,提供一种包括具有近侧部分和远侧部分的细长管状轴的导管;细长管状轴包括内管状构件,内管状构件具有从细长管状轴的远侧部分向远侧延伸的远侧长度。细长管状轴具有限定在其中的膨胀腔和导丝腔,导丝腔至少沿内管状构件的远侧长度延伸。该导管还包括具有近端和远端的远端构件,其中远端构件是整体的并且远端构件的近端被固定到内管状构件的远端,该远端构件具有与内管状构件的导丝腔相连通的导丝腔。导管还包括具有近侧部分、远侧部分和在其间的工作长度的球囊,球囊的近侧部分被密封地联接到细长管状轴的远侧部分。球囊的远侧部分被密封地联接到远端构件并且球囊限定与膨胀腔流体相连通的内室,其中远端构件的近端被设置在内室中。
根据所公开主题的另一方面,公开了一种制作球囊导管的方法。该方法包括提供一种具有近侧部分和远侧部分的细长管状轴;细长管状轴包括内管状构件,内管状构件具有从细长管状轴的远侧部分向远侧延伸的远侧长度,细长管状轴具有限定在其中的膨胀腔和导丝腔,导丝腔至少沿内管状构件的远侧长度延伸。该方法还包括提供一种远端构件,其中远端构件是整体的并且包括近端和远端,远端构件具有限定成穿过其中的导丝腔。将远端构件固定到内管状构件的远端,其中远端构件的导丝腔与内管状构件的导丝腔相连通。提供一种具有近侧部分、远侧部分和在其间的工作长度的球囊;该球囊在其中限定内室。该方法还包括:将球囊的近侧部分联接到管状轴的远侧部分,使得球囊的内室与膨胀腔流体连通,以及将球囊的远侧部分联接到远端构件,使得远端构件的近端设置在球囊内部。
在所公开主题的另一个实施例中,公开了一种部署球囊导管的方法。该方法包括提供导管,该导管包括具有近侧部分和远侧部分的细长管状轴;细长管状轴包括内管状构件,内管状构件具有从细长管状轴的远侧部分向远侧延伸的远侧长度。细长管状轴具有限定在其中的膨胀腔和导丝腔,该导丝腔至少沿内管状构件的远侧长度延伸。该导管还包括具有近端和远端的远端构件,其中远端构件是整体的并且远端构件的近端被固定到内管状构件的远端。远端构件具有与内管状构件的导丝腔连通的导丝腔,并且球囊具有近侧部分、远侧部分以及在其间的工作长度。球囊的近侧部分被密封地联接到细长管状轴的远侧部分,球囊的远侧部分密封地联接到远端构件。球囊限定与膨胀腔流体连通的内室,其中,远端构件的近端被设置在内室中。该方法还包括将导管的球囊定位在体腔内部;以及通过经过细长管状轴的膨胀腔导入加压流体而使球囊膨胀。
为了说明的目的而并非为了限制的目的,现在将详细地参照具体实施例,附图中图解说明了实施例的实例。为了本公开的目的,除非另有说明,在附图中相似的附图标记应指代相似的特征。另外,为了理解的目的,接合导管和相关特征来描述所公开的主题的方法。
图1示出了使所公开主题的特征具体化的球囊导管110的局部剖切侧视图,球囊导管110通常包括具有近侧部分和远侧部分的细长管状轴111、膨胀腔112和至少沿细长管状轴的长度的一部分延伸的导丝腔113。
导管的细长管状轴可以由多种构造制成。例如,细长管状轴可以提供穿丝型(OTW)构造,其中导丝腔通常在细长管状轴的整个长度上延伸。在本实施例中,细长管状轴可以是单件多腔构件,或者可以包括同轴布置,如图1中示意性地示出。因此,细长管状轴可以包括同轴的构造,其中,内管状构件118被设置在外管状构件117的至少一段内,使得外管状构件117和内管状构件118在两者之间限定细长管状轴的膨胀腔112。亦即,该同轴布置包括外管状构件117和内管状构件118,其中膨胀腔112被限定在两者之间。在任一种布置中,即多腔或同轴的内管状构件118延伸超过外管状构件117的远端并且进一步限定导丝腔113,如图1中详细地图示。
作为替代,导管可以是快速交换型(RX)构造,如本领域中所知,并且导管的近侧部包括近侧海波管等。快速交换型导管的远侧剖面可以是如上所述的同轴构造或者多腔构造。在多腔构造中,导管的远侧部包括具有沿其长度延伸的膨胀腔112的细长管状轴,并且还包括至少沿细长管状轴构件的长度的一部分延伸的导丝腔113。膨胀腔112和导丝腔113被设置成彼此相邻。细长管状轴包括内管状构件118,内管状构件118具有从细长管状轴远侧部分的向远侧延伸的远侧长度并且导丝腔至少沿内管状构件118的远侧长度延伸。因此,细长管状轴可以包括多腔构造,并且内管状构件118限定与膨胀腔相邻的导丝腔。为了描述本文但不是为了限制的目的,图1-7中示出了OTW构造。
如本文中所述,内管状构件118可以比外管状轴构件117更具柔性,尽管内管状构件118不必比外管状轴构件117更具柔性。例如,根据另一个实施例,向外管状构件的远侧延伸的内管状构件中的仅一部分可以具有比外管状构件更大的弹性。而且,内构件可以具有多种合适构造,包括单个整体的管,或者利用端到端接头、对接接头或者搭接接头而连接的多个管。
根据所公开的主题,图1中示出了远端构件127。该远端构件是整体的构件并且具有近端127P和远端127D。远端构件127的近端127P被固定到内管状构件118的远端127D。本文中所具体实现的远端构件具有限定成穿过其中并且与内管状构件118的导丝腔113连通联接的导丝腔213。
远端构件127可以具有多种合适的构造。在一个实施例中,如图1中所示,远端构件可以具有通常具有均匀直径和壁厚的圆柱形构造。可替代地并且如图2A中所示,远端构件可以具有向远侧减小的剖面尺寸,例如从远端构件的近端到远端构件的远端的锥度。在本实施例中,远端构件从近端到远端具有基本恒定的锥度。
例如并且参照冠状动脉扩张导管,远端构件也可以沿远端构件的长度具有均匀的或变化的轮廓。远端构件的外剖面尺寸可以在近端和远端之间在远侧方向上减小。例如,在紧挨着球囊远端的远侧位置在位置L处,远端构件的外剖面尺寸或轮廓可以在大约0.018英寸至大约0.028英寸之间的范围内。在一个实例中,在紧挨着球囊的远端的远侧位置,远端构件的剖面轮廓约为0.023英寸。相反,远端构件的远端在位置E的剖面尺寸或轮廓是在大约0.012英寸至大约0.028英寸之间。在一个实例中,在3.0×20 mm球囊的远端构件的远端,远端的剖面轮廓约为0.017英寸。
在如图2B中所示的另一个实施例中,远端构件可以仅在位置L处向球囊114的远端的远侧形成锥形。例如并且仅仅为了说明的目的,图2B示出了在远端构件的近端到位置L之间具有均匀轮廓然后向远侧减小轮廓的远端构件。亦即从远端构件的近端到位置L(其在紧挨着球囊的远端的远侧),远端构件包括大致均匀的剖面轮廓。然而,从位置L到在位置E的远端构件的远端,远端构件127超过球囊的远端形成锥形。在用于冠状动脉扩张的3.0 mm膨胀球囊的一个实例中,在位置L的远端构件127的外剖面尺寸或轮廓可以为大约0.021"并且对于3×20 mm的球囊远端构件127在位置E的进入轮廓可以为大约0.017"。远端构件的横切轮廓测量在远侧球囊密封部的远侧边缘进行。
远端构件可以具有多种合适的剖面形状和构造。在图2A和图2B的实施例中,远端构件包括大致为圆形的剖面构造。例如并且参照冠状动脉扩张导管,远端构件的内直径可以在大约0.008英寸至大约0.038英寸的范围内并且远端构件的外直径可以在从大约0.014英寸至大约0.045英寸的范围内。
在本实施例中,远端构件可以具有小于或等于大约0.006英寸的壁厚。在如图2B中所示的实施例中,远端构件还包括在远侧方向上减小的壁厚。
为了说明的目的并非为了限制的目的,再次参照冠状动脉扩张导管,远端构件可以包括至多大约5 mm的长度。在一个实施例中,远端构件的长度约为3 mm。远端构件可以向球囊的远端的远侧延伸合适长度。例如,远端构件从球囊的远端向远侧延伸至多大约2 mm。
远端构件127的远端可以包括滚圆构造或者钝形构造,以便增加腔的剖面尺寸。可以利用激光、研磨或者其它合适的技术形成该滚圆顶端构造。可以采用的合适的顶端构造的其它实施例,例如,本文中描述的构造还描述于美国申请第11/958,106号、美国专利第7,862,541号、美国申请第12/983,504号、美国专利第7,549,975号、美国专利申请第12/468,745号、美国专利第6,964,750号和美国专利申请第11/241,936号,它们的全部内容以参考的方式并入本文中。
远端构件可以通过多种合适的方式联接到细长管状轴。以举例为目的,可以通过对接接头126或者搭接接头128将远端构件联接到内管状构件,分别如关于图2A和图2B所示。同样地可以使用其它合适的结合部和接头。如图2B中所示,远端构件与内管状构件彼此是同延的。远端构件通常构造成提供弹性并且通常由比内管状构件的相邻剖面更软的聚合材料形成。这样,较软的远端构件可以与内管状构件的外表面重叠并且结合到该外表面,或者远端构件可以重叠内管状构件的外表面并且结合到该外表面。
远端构件可以包括多种合适材料。例如,远端构件可以由多种合适的聚合材料形成。例如,理想的是顶端构件的表面适于与球囊和/或内管状构件的材料熔接或热粘接,如这里进一步的描述,在一个实施例中,远端构件由聚醚嵌段酰胺(PEBAX)或嵌段共聚物或者热塑性材料制成。柔软的远端材料的相对较低的邵氏硬度可以在从大约55D至72D的范围内。在一个实施例中,远端构件至少部分地由比内管状构件的远侧部分更软的聚合材料形成,在近侧方向上与远端构件相邻。远端构件比作为整体的内管状构件更加柔软且更具柔性。这样,远端构件127可以由相对较软的聚合材料形成从而为导管提供非创伤性远侧前端。
在一些实施例中,远端构件是单个的层管状构件,例如能够与内管状构件118和/或球囊的相邻层熔接的聚合物。可替代地,多层构造可以应用于适于与被接合材料(例如内管状构件和/或球囊)熔接或热粘接的暴露层。如果远端构件的材料不适于熔接或热粘接,那么可以采用其它常规的结合或连接技术,例如胶粘剂等。
远端构件127提供柔性的超低断面以获得极好的传递性。该低横切轮廓允许更容易地进入复杂的病变部位。这样,可以使导管在脉管***内行进从而将球囊定位在期望的位置。
根据所公开主题的实施例的导管还可以包括涂层,例如亲水性涂层。例如,在一个实施例中,至少远端构件的外部包括涂层。这种亲水性涂层描述于美国专利公开2010/0285085和美国专利公开2010/0189876,它们的全部内容以参考的方式并入本文中。
如上所述,导管还包括具有萎陷状态和膨胀状态的球囊。该球囊通常包括近侧部分、远侧部分以及在其间的工作长度。该球囊的近侧部分密封地联接到细长管状轴的远侧部分并且球囊的远侧部分被密封地联接到远端构件使得远端构件的近端被设置在内室中。该球囊限定与膨胀腔流体连通的内室。
例如并且参照图1,近侧球囊114包括近侧裙部116p、近侧锥体部115p、远侧锥体部115d和远侧裙部116d。球囊114包括在近侧锥体部115p和远侧锥体部115d之间的工作长度。如本文中的图解说明,近侧裙部被密封地固定到细长管状轴构件。在图1的实施例中,近侧裙部116p联接到外管状构件117。远侧裙部116d被密封地固定到远端构件127。球囊的内室141被限定在球囊的近侧裙部116p和远侧裙部116d之间。内室联接到细长管状轴,与膨胀腔112流体连通。如图1中所示,内室中的远端构件的近端127P与内管状构件118联接。因此,远侧裙部116d被设置在远端构件127的近端127P的远侧。
图3是沿线3-3截取的图1的导管110的剖面。在图3中,远端构件127限定导丝腔213,导丝120延伸穿过导丝腔213。球囊114处于膨胀状态,并且远侧锥体115d从远端构件127向外径向延伸。
图4是沿线4-4所截取的图1的导管110的剖面。在图4中,远侧裙部116d被密封地固定到远端构件127。远端构件127还限定导丝腔213,导丝120延伸穿过导丝腔213。
需要时,可以将远端构件的近端127P设置在球囊内室中的合适位置。例如,在一个实施例中,近端127P可以位于最接近远侧裙部116d的位置,例如用于支架传递***等。在另一个实施例中,近端127P从球囊的远端向近侧隔开,如图2A和图2B中所示,例如用于扩张球囊导管。通常,在内管状构件和远端构件的近端之间的接头或结合部位于球囊内部的中心处或中心的远侧。近端127P在球囊114内部的位置允许导管110与常规导管相比更平稳的逐渐过渡。
图5A示出了根据所公开主题一个实施例的导管,而图5B示出了已知导管。在图5A中,导管包括在内管状构件118的远侧部分和远端构件127的近侧部分之间的逐渐过渡区。图5A示出了联接到球囊114(导丝120设置在其中)内室中的远端构件127的内管状构件118。不透射线标志140被设置在顶端构件127上。球囊的远侧裙部116d被设置在远端构件127的近端的远侧的远端构件上。此逐渐过渡是通过一个或多个同延长度的内管状构件和远端构件而完成,球囊内室中的结合部的位置、远端构件的锥形形状、远端构件使用比内管状构件更软的材料、和/或远端构件的增加长度而实现。相反,图5B示出了内构件到顶端的突然转变。这种已知的构造增加了当移动经过弯曲路径时在导管远侧部分和导管扭折处的硬度。
图6A和图6B分别示出了图5A和图5B的导管的远侧视图,参照根据本文中所公开主题的导管。在图6A中,内管状构件118与远端构件127的结合部被设置在球囊114的内室中并且从远侧裙部116d处的远端构件127与球囊114远侧部分的结合部向近侧隔开。此近侧隔开允许导管的逐渐过渡以便增加弹性并且防止扭折。在图6A中,不透射线标志140被设置在远端构件127上。相反,参照如图6B中所示的常规导管,内构件与顶端的结合部位于球囊远端与内构件的结合部处。如图5B和图6B中所示的这种构造形成突然的和较小柔性的过渡。
如图1和图7中进一步的示出,并且根据所公开主题的另一方面,导管可以包括至少一个不透射线标志。该不透射线标志可以联接到内管状构件。该标志可以由不透射线的材料制成,例如金属或者不透射线加载的聚合物,例如公开于美国专利序列号11/455,382中,该专利的全部内容以参考的方式并入本文中。
标志的位置可以取决于球囊的尺寸。例如,在具有较小球囊的实施例中,可以使用一个不透射线标志,如图1中所示。在使用一个不透射线标志的实施例中,该标志可以位于可膨胀工作长度114w的中央。然而,取决于球囊尺寸,可以在在多种位置设置不透射线标志,包括工作长度段的端部。
图7示出了联接到导管的内管状构件的至少一个标志的另一种布置。导管110具有两个不透射线标志140,标志140位于球囊114的内室141中的内管状构件118上以及沿着球囊114的工作长度114w。在本实施例中,标志140与近侧和远侧锥体部114c大致对准以便将球囊的工作长度114w限定在这两者之间。
具有标志的导管构造的其它实施例描述于美国专利申请第11/775,480号、美国专利申请第12/945,566号、美国专利第7,862,541号、美国专利申请第12/983,504号、美国专利第7,549,975号、美国专利申请第12/468,745号、美国专利第6,964,750号、美国专利申请第11/455,382号、美国专利第7,833,597号、美国专利第7,322,959号、美国专利第7,303,798号、美国专利申请第11/775,480号、美国专利申请第12/945,566号、美国专利公开2010/0285085、美国专利公开2010/0189876和美国专利申请第11/241,936号,上述文件的全部内容以参考的方式并入本文中。
导管可以还包括一种联接到球囊的医疗装置。医疗装置的实例包括支架以及类似地利用所述导管和方法而传递的其它合适装置和植入物。为获得关于示例性支架的细节,例如可参见美国专利第5,507,768号(Lau等人)和美国专利第5,458,615号(Klemm等人),这些文件的内容以参考的方式并入本文中。
包括外管状构件和内管状构件的细长管状轴构件可以具有多层构造,其具有一层可容易结合的材料。例如,内管状构件可以具有便于结合到相邻部件的材料(例如聚酰胺)的外层以及光滑/低摩擦材料(例如HDPE)的内层。
在另一个实施例中,内管状构件是三层管状构件,其具有通常由光滑材料(例如HDPE)形成的内层、例如官能化的聚烯烃胶粘剂聚合物的中间连接层以及可容易结合的外层(例如聚酰胺,例如尼龙,或者聚醚嵌段酰胺(PEBAX))。
在如图1中所示的实施例中,将球囊114描绘成单层球囊。然而,本文也设想了多层球囊。用于导管的多层球囊的一例描述于美国专利第7,828,766号和美国专利申请第12/897,202号中,这些文件的全部内容以参考的方式并入本文中。此外,具有其它球囊构造的导管的各种实施例描述于美国专利第6,923,822号、美国专利申请第11/189,536、美国专利公开第2009/0036829号和第2007/0021772号,这些文件的全部内容以参考的方式并入本文中。
所公开主题的导管尺寸主要决定于所使用球囊和导丝的尺寸、导管类型和动脉或导管必须经过的其它体腔的尺寸、或者被传递支架的尺寸。例如,外管状构件117可以具有大约0.025至大约0.04英寸(0.064至0.10 cm)的外直径,在一些实施例中为大约0.037英寸(0.094 cm),并且外管状构件117的壁厚可以从大约0.002变化至大约0.008英寸(0.0051至0.02 cm),在一些实施例中大约0.003至0.005英寸(0.0076至0.013 cm)。内管状构件118通常具有大约0.01至大约0.018英寸(0.025至0.046 cm)的内直径,在一些实施例中为大约0.016英寸(0.04 cm),并且具有大约0.004至大约0.008英寸(0.01至0.02 cm)的壁厚。导管110的总长度可以在从大约100至大约150 cm的范围内,并且在一些实施例中约为143 cm。球囊114可以具有大约0.8 cm至大约6 cm(0.315英寸至2.362英寸)的长度以及大约0.5至大约10 mm(0.0197至0.3937英寸)的膨胀后的工作直径。远端构件127的长度可以在从1 mm至35 mm的范围内并且内直径为大约0.010至大约0.035英寸(0.025至0.046 cm),在一些实施例中为大约0.016英寸(0.04 cm),并且壁厚为大约0.004至大约0.008英寸(0.01至0.02cm)。本文也设想了其它尺寸,并且上述尺寸只是作为例子而提供。
尽管细长管状轴111的管状构件被图示为具有均匀的内直径和外直径以及壁厚,但这些构件可以各自或者同时在沿细长管状轴长度的各种位置具有锥形的内直径和/或外直径。内管状构件118可以具有锥形的远端(即,通过在管状构件的整个圆周形成均匀的锥形而减小管状构件的外直径),并且软的顶端构件的近端可以重叠在锥形的远端上以便结合到该远端。此外并且例如,顶端构件127可以具有比将要被结合到其上的内管状构件的端部更薄的壁厚,在这种情况下,在结合期间,可以对准内表面并且导致内构件的外表面向远侧流动,以使结合部处的外表面平滑。
根据所公开主题的另一方面,公开了一种制作球囊导管的方法。该方法包括提供一种具有近侧部分和远侧部分的细长管状轴,该细长管状轴包括内管状构件,内管状构件具有从细长管状轴的远侧部分向远侧延伸的远侧长度,该细长管状轴具有限定在其中的膨胀腔和导丝腔,导丝腔至少沿内管状构件的远侧长度延伸。该方法还包括提供一种远端构件,其中远端构件是整体的并且包括近端和远端,该远端构件具有限定成穿过其中的导丝腔。远端构件被固定到内管状构件的远端,其中远端构件的导丝腔与内管状构件的导丝腔相连通。提供一种具有近侧部分、远侧部分和在其间的工作长度的球囊,该球囊在其中限定内室。该方法还包括将球囊的近侧部分联接到细长管状轴的远侧部分,使得球囊的内室与膨胀腔流体连通,以及将球囊的远侧部分联接到远端构件,使得远端构件的近端设置在球囊的内部。
可以利用多种技术可以来联接或以其他方式形成本文中所公开导管的结合部或结合部。例如,参考在球囊和远端构件之间的结合部。为了将球囊的远侧部分联接到远端构件,收缩包覆物可以提供在远端构件和球囊的远侧部分的至少一部分上。利用激光等将球囊的远侧部分的至少该部分热熔接到远端构件。例如,激光可以以螺旋状的方式相对于远端构件的外表面沿其纵向轴线移动。这样,球囊的远侧部分和远端构件的材料将***和熔融。当激光以螺旋状的方式在顶端构件的纵向轴线周围向远侧移动时移动,将在远侧方向上推进较软的和/或熔融的材料从而在收缩包覆物的下面形成锥形形状。一旦完成,则可除去收缩包覆物。远端构件的远端可以是滚圆的,或者利用激光、研磨或其它方法将形状调整为形成创伤性较小的端部。
类似地,当使远端构件的近端结合到内管状构件时,可以在管状构件118、127内部设置芯棒以支撑内腔形状。可以在管状构件118、127上在配对的或联接的表面的位置处设置热缩管(未图示)等,以便于在结合期间形成沿结合部的平滑过渡。在结合形成之后,去除收缩管和芯棒。
可利用常规技术来形成细长管状轴外和内管状构件以及顶端构件,例如通过将已发现可用于血管内导管的材料(例如聚乙烯、聚氯乙烯、聚酯类、聚酰胺类、聚酰亚胺类、聚氨酯类和复合材料)进行挤出和颈缩。可利用常规的结合方法(例如但不限于熔接或者使用胶粘剂)将各种构件加以连接。内管状构件和外管状构件可以是多层管,或者端到端连接的管段,如对于球囊导管轴所通常知道的。尽管细长管状轴被图示为具有内和外管状构件,但可以采用多种合适的轴构造,包括具有在其内挤出的并列腔的多腔挤出轴。对于快速交换型构造而言,在快速交换型实施例(未图示)中,外管状构件还可以包括具有高强度构件(例如在近侧轴部和/或经过导丝近侧端口的海波管)的支撑构件。示例性的构造公开于美国专利第7,906,066号中,该专利的全部内容以参考的方式并入本文中。
在制造期间,可以利用常规技术形成球囊并且利用激光熔合或者热熔合中的至少一种将球囊结合到远端构件。在球囊远侧裙部的热熔合期间,可以将球囊的远侧锥体冷却到远端构件的基本剖面例如通过在远侧锥体处引导冷却流体(例如,空气流)。在结合之前,球囊的远侧裙部116可以具有与远端构件127外直径紧密配合的内直径,使得所形成远侧裙部密封件具有低断面。在组装期间,将远端构件127设置在远侧裙部116d内。因此,在远端构件127位于远侧裙部116d下方的适当位置的情况下,在远侧裙部116d和远端127之间形成结合,如本文中所描述。具有其它球囊构造的导管的各种实施例描述于美国专利第6,923,822号、美国专利申请第11/189,536号、美国专利公开第2009/0036829号和第2007/0021772号,这些文件的全部内容以参考的方式并入本文中。用于导管的多层球囊的一例描述于美国专利第7,828,766号和美国专利申请第12/897,202号中,这些文件的全部内容以参考的方式并入本文中。
在所公开主题的另一个实施例中,公开了一种部署球囊导管的方法。该方法包括提供导管,该导管包括具有近侧部分和远侧部分的细长管状轴,该细长管状轴包括内管状构件,内管状构件具有从细长管状轴的远侧部分向远侧延伸的远侧长度。细长管状轴具有膨胀腔和导丝腔限定在其中的,该导丝腔至少沿内管状构件的远侧长度延伸。该导管还包括具有近端和远端的远端构件,其中远端构件是整体的并且远端构件的近端被固定到内管状构件的远端。远端构件具有与内管状构件的导丝腔连通的导丝腔,并且球囊具有近侧部分、远侧部分和在其间的工作长度。球囊的近侧部分密封地联接到细长管状轴的远侧部分,球囊的远侧部分密封地联接到远端构件。球囊限定与膨胀腔流体连通的内室,其中,远端构件的近端被设置在内室质中。该方法还包括将导管的球囊定位在体腔内部以及通过经过细长管状轴的膨胀腔导入加压流体而使球囊膨胀。
虽然本文中利用某些实施例描述了公开的主题,但本领域技术人员将认识到在不背离其范围的前提下,可对所公开主题做出各种修改和改进。此外,尽管本文中描述了所公开主题的一个实施例的独立特征,或者在一个实施例但不在其它实施例的图示中示出了独立特征,但应当理解的是一个实施例的独立特征可与另一个实施例的一个或多个特征或者多个实施例的特征相结合。
应当理解的是,可以对本公开的主题的以上描述作出各种修改、变化和调整,并且这些修改、变化和调整意图被包括在所附权利要求及其等同物的含义和范围内。
Claims (24)
1.一种导管,包括:
具有近侧部分和远侧部分的细长管状轴,所述细长管状轴包括内管状构件,所述内管状构件具有从所述细长管状轴的远侧部分向远侧延伸的远侧长度,所述细长管状轴具有限定在其中的膨胀腔和导丝腔,所述导丝腔至少沿所述内管状构件的远侧长度延伸;
具有近端和远端的远端构件,其中,所述远端构件是整体的并且所述远端构件的近端被固定到所述内管状构件的远端,所述远端构件具有与所述内管状构件的导丝腔连通的导丝腔;以及
具有近侧部分、远侧部分和在其间的工作长度的球囊,所述球囊的近侧部分密封地联接到所述细长管状轴的远侧部分,所述球囊的远侧部分密封地联接到所述远端构件,所述球囊限定与所述膨胀腔流体连通的内室;
其中,所述远端构件的近端以及所述内管状构件的远端沿所述球囊的工作长度被设置在所述内室中,所述远端构件在所述远端构件固定到所述内管状构件的远端所在的位置与紧挨着所述球囊远端的远侧的位置之间具有均匀的剖面轮廓,并且在紧挨着所述球囊远端的远侧位置的远侧具有减小的剖面轮廓。
2.如权利要求1所述的导管,其中,所述远端构件具有从在紧挨着所述球囊远端的远侧到所述远端构件的所述远端的基本恒定的锥度。
3.如权利要求1所述的导管,其中,所述远端构件向所述球囊的远端的远侧形成锥形。
4.如权利要求1所述的导管,其中,所述远端构件在紧挨着所述球囊的远端的远侧位置具有在0.018英寸至0.028英寸之间的外剖面尺寸,并且所述远端构件的远端包括在0.012英寸至0.022英寸之间的外剖面尺寸。
5.如权利要求1所述的导管,其中,所述远端构件具有在0.010英寸至0.035英寸之间的内直径。
6.如权利要求1所述的导管,其中,所述远端构件的壁厚在远侧方向上减小。
7.如权利要求1所述的导管,其中,所述远端构件具有小于或等于0.006英寸的壁厚。
8.如权利要求1所述的导管,其中,所述远端构件具有至多5 mm的长度。
9.如权利要求1所述的导管,其中,所述远端构件向所述球囊的远端的远侧延伸2 mm。
10.如权利要求1所述的导管,其中,所述远端构件的远端包括滚圆构造或者钝形构造中的至少一种。
11.如权利要求1所述的导管,其中,所述远端构件与所述内管状构件通过搭接接头或者对接接头中的至少一种而联接。
12.如权利要求1所述的导管,其中,所述远端构件包括具有在55D至72D之间的邵氏硬度的材料。
13.如权利要求1所述的导管,其中,所述远端构件包括嵌段共聚物或者热塑性材料中的至少一种。
14.如权利要求1所述的导管,其中,所述远端构件的外部包括涂层。
15.如权利要求1所述的导管,其中,所述球囊的远侧部分包括设置在所述远端构件的近端的远侧的远侧裙部。
16.如权利要求1所述的导管,还包括联接到所述内管状构件的至少一个不透射线标志。
17.如权利要求1所述的导管,还包括联接到所述球囊的医疗装置。
18.如权利要求1所述的导管,其中,所述细长管状轴包括同轴的构造,所述内管状构件设置在外管状构件的至少一段中,所述外管状构件和所述内管状构件在两者之间限定所述细长管状轴的膨胀腔。
19.如权利要求1所述的导管,其中,所述细长管状轴包括多腔构造,所述内管状构件限定与所述膨胀腔相邻的所述导丝腔。
20.一种制作球囊导管的方法,包括:
提供具有近侧部分和远侧部分的细长管状轴,所述细长管状轴包括内管状构件,所述内管状构件具有从所述细长管状轴的远侧部分向远侧延伸的远侧长度,所述细长管状轴具有限定在其中的膨胀腔和导丝腔,所述导丝腔至少沿内管状构件的远侧长度延伸;
提供远端构件,其中,所述远端构件是整体的并且包括近端和远端,所述远端构件具有限定成穿过其中的导丝腔;
将所述远端构件固定到所述内管状构件的远端,使得所述远端构件的导丝腔与所述内管状构件的导丝腔连通;
提供具有近侧部分、远侧部分和在其间的工作长度的球囊,所述球囊在其中限定内室;
将所述球囊的近侧部分联接到所述细长管状轴的远侧部分,使得球囊的内室与所述膨胀腔流体连通;以及
将所述球囊的远侧部分联接到所述远端构件,使得所述远端构件的近端以及所述内管状构件的远端沿所述球囊的工作长度设置在所述内室内,所述远端构件在所述远端构件固定到所述内管状构件的远端所在的位置与紧挨着所述球囊远端的远侧的位置之间具有均匀的剖面轮廓,并且在紧挨着所述球囊远端的远侧位置的远侧具有减小的剖面轮廓。
21.如权利要求20所述的方法,其中,将所述球囊的远侧部分联接到所述远端构件包括:
在所述球囊的远侧部分的至少一部分和所述远端构件上设置收缩包覆物;
将所述球囊的远侧部分的至少该部分热粘接到所述远端构件;以及
去除所述收缩包覆物。
22.如权利要求20所述的方法,还包括使所述远端构件的远端滚圆。
23.如权利要求20所述的方法,还包括使所述远端构件从紧挨着所述球囊远端的远侧到所述远端形成锥形。
24.如权利要求20所述的方法,其中,所述球囊至少通过激光熔合或者热熔合结合到所述远端构件。
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- 2012-05-25 WO PCT/US2012/039700 patent/WO2012162661A1/en active Application Filing
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CN103764217A (zh) | 2014-04-30 |
US20120302994A1 (en) | 2012-11-29 |
US11383070B2 (en) | 2022-07-12 |
CN107007921A (zh) | 2017-08-04 |
US20200069924A1 (en) | 2020-03-05 |
US20220370770A1 (en) | 2022-11-24 |
US10406329B2 (en) | 2019-09-10 |
CN103764217B (zh) | 2017-03-15 |
EP2714179A1 (en) | 2014-04-09 |
WO2012162661A1 (en) | 2012-11-29 |
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