CN115025374A - 带接缝的柔性导管轴框架 - Google Patents
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Abstract
本发明题为“带接缝的柔性导管轴框架”。本文的设计可以用于具有支撑管的柔性和防扭结导管,该支撑管可以径向膨胀以使它能够在组装期间在位于心轴上的内衬之上滑动。这些设计足够柔性以允许导管进入远程血管阻塞,但也受益于良好的压缩和拉伸刚度。这些设计可以具有激光切割的框架,其具有周向不连续肋撑条的互锁结构。可以将不连续部分对准以形成至少一个连续轴向接缝,该连续轴向接缝能够分离以允许在制造期间进行径向膨胀。一系列聚合物外护套可以涂覆或封装框架的撑条,从而提供可变刚度并防止互锁结构的脱离接合,同时导管被推动穿过弯弯曲曲的解剖结构。
Description
技术领域
本公开整体涉及用于在血管内医学治疗期间进入血管的装置和方法。更具体地,本公开涉及一种导管,该导管能够径向膨胀以促进导管的制造和组装。
背景技术
导管在血管内医学治疗中提供广泛的功能。它们通常是由医用级材料制成的细小管,该细小管可插入体内并且可用于递送药物或其他装置、执行外科手术、从血管中移除堵塞以及各种其他目的。
存在许多进入挑战,这可使得进入靶部位变得困难。远处区域(诸如神经血管床)使用常规技术是具有挑战性的,因为靶脉管直径小、相对于插入部位较远并且高度迂回。用于去除这些区域中的血管阻塞的抽吸和/或通路导管需要能够承受高挠曲应变而不会扭结和前进穿过套环和越来越小的血管尺寸,而不会造成创伤,以便进入靶部位。导管将必须用多个套环在卷绕路径中导航的情况并不少见,其中血管段可在仅几厘米的行进范围内快速连续地具有若干个极端弯曲。
导管还必须具有良好的压缩刚度(为了可推动性,以及当凝块取回装置被撤回到导管中时的稳定性和完整性)和良好的拉伸刚度(以避免当被置于张力下时,诸如在被撤回到外护套中同时保持大的凝块时的拉伸和变形)。管理从近侧节段到远侧节段的刚度过渡以避免扭结对于这些装置至关重要。导管还必须允许其他装置容易地传递穿过内腔。出于这些原因,可跟踪性、柔韧性、抗扭结性和内部润滑性通常是与这些手术中使用的导管相关的关键设计参数。然而,传统导管的设计者在不进行较大取舍的情况下有效组合这些特性一直都是很棘手的。
通过改变材料或调整制造导管的方式,可以针对特定应用定制导管的不同节段的刚度。许多当前的导管通过利用定制加工的金属支撑框架骨干改变编织构件骨干的构型(改变编织物PIC计数或线圈节距)和/或通过改变周围聚合物材料的计示硬度而从较刚性材料过渡为较软材料。用于增强导管轴的编织线的线圈通常是连续的金属超弹性或尺寸非常细的不锈钢,其可能易于扭结并且难以用均匀产品所需的一致性制造。这些材料还可增加了相当高的成本和复杂性。
必须考虑到辅助装置(诸如导丝、微导管、凝块取回/支架装置等)容易递送穿过内腔,而没有过多的因粘合产生的摩擦。许多现代装置试图利用内部低摩擦衬里来大大增强导管内腔的润滑性。此类装置可以是制造复杂的,因为编织物或金属支撑框架骨干的内径必须与构造期间心轴上的内衬的外径大致相同或略微小于该内衬的外径。当前的骨干设计无法实现在组装期间在没有过度摩擦的情况下在衬里上滑动所需的径向膨胀。
本设计旨在提供改进的导管支撑框架和制造方法以解决上述缺陷。
发明内容
本公开的创新涉及控制沿着导管轴的长度的轴向刚度和横向刚度,并且允许轴的下面的支撑管能够径向膨胀,以在制造期间组装在心轴上的衬里上。导管轴管可以例如从海波管切割成轴向系列的周向不连续肋。肋可以形成互锁结构,以提供对拉伸伸长和压缩缩短两者的轴良好阻力,同时保持出色的横向柔韧性。肋的周向不连续部分的对准可以形成纵向接缝,这些纵向接缝允许轴的框架膨胀以便于与低摩擦内衬组装。这些设计可以通过改变在轴的不同轴向段上切割成支撑管的特征部的配置来管理沿轴的长度的刚度过渡,以避免扭结。
该导管可具有轴,该轴包括支撑管、近侧端部和远侧端部。支撑管可具有围绕纵向轴线设置的内衬。支撑管可具有由多个周向不连续肋撑条形成的轴向系列的互锁段。这种结构可以沿着纵向轴线形成基本上管状的轮廓并且限定穿过延伸穿过这种结构的内衬的内腔。在一些示例中,脊可以连接多个肋中的每个肋,其中由于肋中的周向不连续部分,脊遵循围绕并沿着支撑管的轴线的非线性轮廓。
由于轴向分离在互锁段的肋中的相对纵向对准,支撑管的周向不连续肋可以在支撑管中形成一个或多个轴向接缝。以此方式,支撑管可以类似于翻盖一样沿接缝径向开口。在组装之前,支撑管可以具有等于或略微小于内衬的外径的标称未膨胀内径。当膨胀时,支撑管可具有略微大于内衬的外径的膨胀内径。
也可以改变相邻互锁段之间的间隔,以调整支撑管的不同轴向节段中的导管刚度。在一个示例中,在第一对相邻互锁段之间测量的第一段节距可以与在第二对相邻互锁段之间测量的第二段节距相同。在另一个示例中,在第一对相邻互锁段之间测量的第一段节距可以与在第二对相邻互锁段之间测量的第二段节距不同。
互锁段围绕一个或多个轴向接缝装配在一起的方式可以采取多种形式。在一个示例中,轴向系列的互锁段中的每个互锁段可以具有顶半部,该顶半部可以具有从相应的肋撑条延伸的一对内凹齿。与之相反,互锁段可以具有底半部,其中一对外凸齿从相应的肋撑条延伸,这可以限定和结合它们之间的接收空间。在一些情况下,互锁段的内凹齿和外凸齿可以具有三角形、四边形或其他多边形形状。在其他示例中,齿可以形成基本上L形的突出部。
底半部的接收空间与顶半部的内凹齿之间的并置可以被配置成使得各半部彼此互补接合。当支撑管被组装时,这种接合产生一个或多个轴向接缝的对准间隙。该间隙可以由底半部的接收空间与顶半部的内凹齿之间的交接部的周边限定,使得一个或多个接缝沿支撑管的长轴连续。当接缝遵循围绕沿轴线的齿的突出部的周边时,它可以具有周向和轴向非线性轮廓。脊也可以遵循非线性路径,沿着肋在顶半部和底半部之间交替。
根据给定手术的目的,支撑管的远侧端部可以被构造成具有多个不同的末端或口中的任一者。在一种情况下,远侧端部可以具有大致垂直于纵向轴线的面。该面可以是最远侧的肋,或更具体的环形托架。这种面可允许附接治疗末端、可膨胀的口或其他类似的装置。
在其他情况下,用于导管轴主体的柔性支撑管可以具有激光切割的撑条框架,从而形成沿着支撑管的纵向轴线分布的基本上圆形的肋。肋可以围绕支撑管的圆周具有一个或多个周向不连续部分。为了连接各个肋,脊可以延伸支撑管的长轴的长度,从而围绕管的圆周和由肋中的不连续部分产生的间隙导航。支撑管的远侧端部可以具有面,该面被构造用于连接导管末端或口以进行血管内手术。
肋中的周向不连续部分可以产生间隙,这些间隙可以对准以形成一个或多个轴向接缝。一个或多个接缝的连续性可以为支撑管提供一些径向膨胀能力。这种膨胀可以使支撑管的尺寸被设定为标称内径小于内部低摩擦衬里的外径。当导管在制造期间组装时,然后可以使支撑管膨胀以在心轴上的衬里之上滑动。
撑条框架的肋可以被分组以形成沿纵向轴线具有基本上管状的轮廓的轴向系列的互锁段。互锁段可各自具有顶半部和底半部。在一些示例中,各半部可以被穿过纵向轴线的平面和平行于轴线的一个或多个接缝中的一个接缝的至少一部分划分。在一些示例中,一对内凹齿可以从顶半部上的互锁段的相应肋撑条延伸。以类似的方式,相同互锁段的对应的底半部可以具有从相应的肋撑条延伸并界定接收空间的一对外凸齿。
互锁段可以对准,使得顶半部的每对内凹齿和底半部的每对外凸齿均彼此并置,但是当支撑管被组装时,通过一个或多个轴向接缝彼此周向分离。结果,齿可以像拉链一样装配在一起,但不能彼此固定连接。顶半部的内凹齿可以驻留在由底半部的外凸齿形成的接收空间中。如果齿被成形为使得存在对于膨胀的物理止动件,则内凹齿与外凸齿的接收空间的这种重叠接合也可以限制支撑管的轴向膨胀。
互锁段的每个顶半部的内凹齿和每个底半部的外凸齿可以具有垂直于支撑管的纵向轴线的突出部。在其他示例中,齿可以具有平行于纵向轴线的突出部或平行且垂直于轴线的突出部。这些形状与齿在接收空间中的重叠相结合,可以意味着一个或多个轴向接缝是由互锁段的底半部的外凸齿与顶半部的内凹齿的交接部的周边限定的连续间隙。该周边可以赋予一个或多个轴向接缝周向和轴向非线性轮廓。接缝允许支撑管径向膨胀,同时由于齿的接合而限制总体膨胀。齿的接合也可以限制支撑管的任何轴向膨胀。
也可以改变支撑管结构的尺寸以改变导管的不同部分中的刚度分布。例如,肋撑条的第一肋宽度可以与另一肋撑条的第二肋宽度相同或不同。类似地,在第一对相邻互锁段之间测量的第一段节距可以与在第二对相邻互锁段之间测量的第二段节距相同或不同。
也可使用除尺寸方面之外的其他加工来调整导管的刚度和弯曲柔韧性。例如,一系列聚合物护套可以在支撑管上回熔焊接以粘结下面的结构并形成导管主体的外表面。这些外护套可具有不同的计示硬度以形成具有更大柱刚度的近侧部分和并过渡到具有更大横向柔韧性的远侧部分。
还可包括用于制造导管的方法。该方法可以包括将低摩擦内衬定位在第一施加心轴上的步骤。衬里可以是PTFE或类似聚合物。
另一步骤可涉及形成具有轴向接缝的支撑管,该轴向接缝允许支撑管的径向膨胀。在一些示例中,支撑管可以由形状记忆超弹性合金(例如镍钛诺(NiTi))的海波管加工而成,以具有等于或略微小于施加心轴上的内衬的外径的未膨胀内径。
支撑管可以被激光切割以具有沿纵向轴线设置在近侧端部与远侧端部之间的多个周向不连续肋。可以通过沿着轴线对准肋的周向不连续部分来形成接缝。肋因此也可以形成沿着圆周和轴向非线性轮廓在顶半部和底半部之间交替的脊,其连接每个肋。
轴向接缝可以通过使支撑管在基本上管状的第二超大号心轴上膨胀来拉伸。超大号心轴的外径可以略微大于施加心轴上的内衬的外径。然后,该方法可以具有将超大号心轴上的激光切割的支撑管冷却到至少低于合金的奥氏体结束(Af)温度,并且理想地处于或低于马氏体结束(Mf)温度的步骤。作为替代方案,在超大号心轴之上膨胀之前,可以将支撑管冷却到所需的温度。然后可以移除第二超大号心轴,并且将径向膨胀的支撑管围绕第一施加心轴上的内衬定位。
可以将多个外部聚合物护套回熔焊接或层压到支撑管。护套可以呈轴向系列并且具有不同的计示硬度。在替代示例中,护套可以以径向系列施加,或者是材料的共混物。回熔焊接工艺可以通过流过肋之间的间隙来粘附衬里和支撑管。然后,一旦结构已粘结,就可以移除第一施加心轴。
在结合附图查看以下具体描述之后,本公开的其它方面和特征对于本领域普通技术人员将变得显而易见。
附图说明
参考下面的描述并结合附图进一步讨论本发明的上述方面和另外方面。附图未必按比例绘制,而是重点举例说明本发明的原理。附图仅以举例方式而非限制方式描绘了本发明装置的一种或多种具体实施。
图1是根据本发明的各方面的位于心轴上的可膨胀导管支撑管的视图;
图2是图1的平面图案的表示,示出了根据本发明的各方面的互锁段的顶半部和底半部;
图3示出了根据本发明的各方面的用于支撑管的另一示例性平面图案;
图4是根据本发明的各方面的另选可膨胀导管支撑管的视图;
图5示出了根据本发明的各方面的具有施加的外部聚合物层的柔性导管支撑管;
图6示出了根据本发明的各方面的图5的横截面,示出了示例性外部聚合物层构型;
图7是根据本发明的各方面的另选外部聚合物层构型的视图;
图8是根据本发明的各方面的具有附接的可膨胀远侧末端的可膨胀导管支撑管的视图;
图9示出了根据本发明的各方面的具有附接的可膨胀远侧末端的可膨胀导管支撑管的另一示例;
图10a-图10e是根据本发明的各方面的用于可膨胀导管支撑管的可能制造方法的图示;并且
图11是根据本发明的各方面的用于图10a-图10e所示的制造方法的过程流程图。
具体实施方式
本文提出的设计的目的可以是用于血管应用的具有可变柔性且抗扭结的细长导管。这些设计足够灵活以进入远程血管闭塞,但也受益于良好的压缩和拉伸刚度。这些设计可以具有近侧端部和远侧端部以及在近侧端部和远侧端部之间延伸的激光切割的支撑管框架。该支撑管框架可以具有肋撑条的互锁结构,这些肋撑条具有至少一个连续分离接缝,以允许在制造过程期间的一些径向膨胀,同时维持纵向刚度。低摩擦内衬可以设置在框架节段的内表面上。外部聚合物层或层压护套可以涂覆或封装框架的撑条,从而防止当导管被推动穿过弯弯曲曲的解剖结构时互锁结构的脱离接合。远侧面可以允许连接多个导管末端中的任一者,例如用于抽吸和凝块取出的可膨胀漏斗。
该导管还可与相对低轮廓的进入护套和外部导管兼容,使得患者腹股沟中的穿刺伤口(在股骨进入的情况下)可容易和可靠地闭合。虽然以下描述在许多情况下是以神经血管床中的机械取栓凝块取出或其他治疗为背景的,但所述装置和方法可容易地适用于其他手术以及其他身体通道中。
现在参考附图详细描述本发明的具体示例,其中相同的参考标号指示功能性相似或相同的元件。接近血管内的各种血管(无论是冠状血管、肺血管还是脑血管)涉及熟知的手术步骤和许多常规的可商购获得的附件产品的使用。这些产品可涉及广泛用于实验室和医学规程中的血管造影材料、旋转止血阀、鲁尔接口和导丝。尽管没有特别按名称提及,但是当这些产品或类似产品不可避免地与以下描述中的本发明的装置和方法结合使用时,其功能和确切构造未进行详细描述。
转到附图,图1中示出了用于患者的血管中的血管内手术的导管轴支撑管框架100的视图。支撑管示出为围绕位于心轴10上的低摩擦内衬160安置。支撑管100通常可以是在近侧端部112和远侧端部114之间的管状撑条框架,并且具有内腔119。多个肋撑条118可以围绕纵向轴线111形成延伸的轴向系列。撑条可以例如由海波管激光切割而成。在另一示例中,支撑管可以是注射模制的聚合物支撑结构。还可以将特征部结合到撑条框架中,这使围绕某些平面的弯曲偏置或鼓励扭转以减少所施加的应变。以这种方式,导管可保持出色的横向柔韧性,但不会在受拉时膨胀或在受压时扭结。
肋撑条118可以是周向不连续的,使得纵向接缝116分离支撑管100的结构以允许一些径向膨胀。例如,在制造期间,当激光切割的支撑管结构可以膨胀以装配在位于支撑心轴10上的内衬160或其他层之上时,径向膨胀可以是有益的,如本文所示。在没有这种在衬里之上膨胀的能力的情况下,在组装过程中会有太多的摩擦而无法使框架在衬里/心轴对上有效地滑动。此外,如果支撑管的尺寸从一开始就大于衬里的直径,则它不会同心地位于衬里上,并且所得导管的壁厚将太大。
然后,支撑管100可以具有比心轴上的衬里160的外径162更大的膨胀内径108。在这种不受约束的状态下,膨胀的ID 108只能比衬里的OD稍大(0.001英寸,或至多0.002英寸–0.003英寸)。
尽管接缝116可以沿着支撑管100的整个长度连续,但是脊126可以通过肋撑条118在接缝的径向相对侧上的周向连续延伸而存在。脊126纵向连接该结构,但可以实现比例如使用平行于纵向轴线111的支撑管100的长度延伸的连续和线性脊构件存在的柔韧性更大的柔韧性。
在一些情况下,支撑管100可以与可膨胀末端节段310一体形成,当从护套或外导管的远侧端部展开时,该可膨胀末端节段可以膨胀到更大的径向尺寸。扩大的末端可以提供改善的抽吸效率,并且还可以实现在捕获的凝块从血管中移出并被摄取后逐渐压缩。
图2中示出了来自图1的支撑管100的平坦切割图案的示例。肋撑条118的图案可以形成一系列互锁段120、130、140。如图所示,互锁段可以彼此轴向对称,或者图案可以被切割,因此存在不规则性并且区段不对称。纵向轴线111可以将互锁段120、130、140的图案划分为顶半部102和底半部104。两个半部都可以具有构造成当组装管时与另一半部互锁的特征部,从而形成接缝116,同时抵抗轴向膨胀并改进导管的后备支撑。轴向刚度可以通过连接肋118并遵循在支撑管100的顶半部102和底半部104之间交替的非线性路径的脊部126来辅助。
例如,互锁段的顶半部102可以具有一对内凹齿103,其切割成如图所示的主要为方形的形状。类似地,各段的底半部104可以具有一对外凸齿105。外凸齿可以为每个互锁段界定接收空间106,内凹齿103可以接合在该接收空间处。在其他示例中,齿可具有三角形、四边形或其他多边形形状,其可以互锁并且还改善导管的扭矩响应。
可以理解,用于联接顶半部102的内凹齿103和底半部104的外凸齿105的接收空间106的尺寸可以针对不同的互锁段120、130、140而不同地设定,使得由内凹齿和接收空间形成的间隙的尺寸以根据支撑管100的不同节段的设计参数而变化。当固定在一起时,互锁段可以因此影响组件沿某些平面的柔韧性和/或偏置弯曲。
支撑管100的弯曲刚度也可以通过改变切割宽度和肋宽度的组合来调整。在切割宽度保持恒定的情况下(例如激光器束的宽度)可改变肋宽度以调整弯曲刚度。在切割宽度变化的情况下,肋宽度可保持恒定或变化,并且可使用激光器移除材料。应当理解,通过使用与激光器束的切割宽度相等的切割宽度,没有材料片被移除,并且制造成本大大降低。另一方面,通过使用激光移除材料片,可实现轴设计的更大变化。还应当理解,可使用两种方法的组合,因此轴在近侧端部处结合了更具成本效益的切割/处理,并且在远侧保留了更昂贵的方法,其中可能需要更复杂的切割来实现所需的柔韧性性能。例如,轴的近侧节段可以从SS切割并且连接到从诸如NiTi的超弹性合金切割的远侧节段。这种构造可以降低总体成本,同时提供为装置的远侧端部提供NiTi的益处,在这种情况下需要增强的紧密弯曲曲线的弹性并且还提供一些膨胀和恢复特性。对于这种装置,SS和NiTi节段可通过焊接直接接合、通过焊接到可焊接性更强的中间金属诸如铂标志带上接合。作为另外一种选择,激光切割的互锁特征部可沿纵向方向将两个切割管节段保持在一起。外膜盖或护套可以将管沿径向方向固定在一起。
在一些示例中,互锁段的齿之间的小尺寸的轴向间隙和径向间隙可以提供对支撑管的伸长和/或压缩的阻力,同时维持导航穿过脉管系统所需的横向柔韧性。当支撑管被撤回到外导管中时,支撑管可以防止被拉伸,并在通过管腔撤回支架或另一装置时保持稳定性以防止聚拢。
图3示出了另选平面图案示例。所示图案具有内凹齿103和外凸齿105,其为基本上L形的突出部121或其变型,其可以将互锁齿在周向方向和纵向方向两者上取向。与使用连续和刚性脊构件连接肋的情况相比,接缝的不连续部分允许导管具有更大的挠曲自由度。与图2所示的图案相比,这种齿取向可以帮助防止当导管导航穿过身体通道中的紧密弯曲时的齿103、105的铰链,但代价是限制支撑管100的一些径向膨胀能力。在层压外护套(未示出)之后,这种结构可以在拉伸和压缩两者中提供高有效模量,并在抵抗阻力恢复时提供良好的完整性。
还可以调整支撑管100的激光切割框架的各种尺寸参数以调整导管轴以用于所需的柔韧性性能,如图4所示。互锁段之间的节距可以被设计成使得支撑管100结构在更近侧的区域中更硬且更密集并且在远侧区域中更柔韧。一种用于测量互锁段节距的方法可以是一个互锁段130的最远侧肋124与相邻互锁段140的最远侧肋134之间测量的纵向距离。因此,节距可以改变给定互锁段的分离接缝116的中间长度,而不影响互锁能力。
例如,互锁段130的第一段节距122可变窄或缩短,以在支撑管的近侧端部112附近提供更好的可追踪性和扭矩响应。类似地,在横向柔韧性更受关注的远侧端部114附近,支撑管100可以过渡到互锁段140的大于第一段节距122的第二段节距132,以更好地优化那些物理能力。节距的变化还改变了在相邻接收空间106中互锁的齿延伸部117之间的间隔。
段节距122、132可另选地沿着支撑管100的纵向长度连续变化。因此,管的相邻互锁段120、130、140可以随着每个连续段以小的但递增恒定的百分比逐渐变得更靠近或进一步分开。连续变化的节距将导致沿支撑管100的长度更渐进的刚度过渡并且提供扭转刚性,同时防止扭结点的形成,扭结点原本可能在具有较高刚度梯度的过渡处形成。这种构型还可有助于通过支撑管100的长度递送平衡且一致的推动力或推进力,并且确保操作者在手术期间由操纵导管接收到良好的触觉反馈。
可以改变以优化支撑管100的刚度和柔韧性的另一设计变量是形成肋118的撑条的宽度或横截面形状。例如,较小的肋横截面可以通过在肋之间提供更大的空间而允许支撑管更容易地挠曲。如图4所示,更近侧的互锁段120的撑条的肋宽度141可以大于另一互锁段140的第二更远侧的肋宽度142。
如图5所示,切割的支撑管100可以具有围绕互锁段的肋118的外部聚合物层180或护套。外部聚合物层180或护套可由各种医用级聚合物制成,诸如PTFE、聚醚嵌段酰胺或尼龙。可对材料进行选择,例如,使得随着接近近侧端部112,较近侧区段通常更硬并且柔韧性更差(通过硬度计硬度、挠曲模量等表示),以增加导管的柱强度和可推动性。类似地,可以在远侧使用更软、更柔性的材料段。
在一个示例中,外护套180可以在激光切割的海波管上回熔焊接并进入肋118之间的空间。在这样的过程之后,有时在激光切割的肋撑条118的位置处可能有径向突出的材料。在这种情况下,可以将组件拉伸穿过定型模具以去除撑条上的任何多余材料,使得支撑管100的轴的总外径对于所需的递送轮廓是一致的。另选地,可能需要不均匀或带肋的轮廓以减少导管的外表面与外护套或血管之间的摩擦。
在另一个示例中,外部聚合物层180可以在制造期间被注塑模制到支撑管100的空间中。在另一个示例中,层或护套180可以使用具有用于粘合的底漆成分的粘合剂粘合到支撑管100的撑条118。
图6中显示了穿过图5的导管主体的壁的横截面图。内衬160诸如PTFE可提供减少与被推进穿过导管的腔119的辅助装置的摩擦的优点。如所提到的,外部聚合物层或护套180可以被回熔焊接、注塑模制或以其他方式粘附到激光切割的支撑管结构。
内部和外部聚合物涂层的使用,其可以通过激光切割的支撑管100中的空间延伸到彼此中、相互交接或共混,有助于允许互锁段的齿在没有塑性变形的情况下挠曲和互锁。因此,肋118可以具有一些独立的挠曲能力,同时具有由一个或多个外护套施加的有限约束。
内衬160和外护套180的布局和构造可以变化。例如,外护套180的材料可以径向向内延伸到或超出支撑管100的内表面,或者延伸到支撑管的内径和外径内肋撑条118间隙的中间位置。另选地,外护套180可以仅粘结到支撑管的外径的表面。具有仅粘结到外径的护套180将允许支撑管的肋撑条118更自由地弯曲,因为相对于支撑管的壁厚更径向向内延伸的护套可使导管变硬。支撑管肋118之间的未填充的间隙使肋自由轴向移动。刚度的其他变化可以通过具有由复合系列的径向护套182组成的外护套180来实现,每个径向护套具有不同的厚度和/或由不同的材料制成。还可以理解,径向系列的护套182可以以不同方式布置用于导管的各个轴向段。
如前所述,外部聚合物层也可以是由轴向系列的聚合物护套形成的。不同的护套或护套组183、184、185可以沿着支撑管100的轴线以离散的长度围绕肋118设置,以便给导管的管状部分的不同节段提供不同的可推动性和柔韧性特性,如图7所示。所示的取向仅用于演示而非限制。图7展示了具有三个聚合物外部护套层,分别为183、184和185的支撑管100的横截面。可以改变各因素,诸如各个层的壁厚和长度,以赋予支撑管100的各部分刚度或柔韧性。还必须选择尺寸,以使导管满足针对应用而确定的临界弯曲标准。
在许多示例中,可以选择材料使得护套层183、184、185的硬度在远侧降低。通过将护套配置成轴向系列,并使用具有不同计示硬度的聚合物,可以使导管的总体刚度从较硬的且可推动的近侧端部向极具柔性的远侧端部过渡。外护套层的一般选择可以是PTFE和但可将更专用的材料或共混物掺入到支撑管100的特定轴向节段中。在导管的更近侧节段(其中轴向刚度、抗塌缩性很重要)中,护套区段220、230可由合适的坚韧聚合物诸如聚酰亚胺、尼龙、聚丙烯或具有较高密度的其他材料制成。对于需要柔韧性的更远侧节段,各护套段可为例如聚氨酯、PVC、低密度聚乙烯(LDPE)或具有合适模量和柔软度的其他聚合物。这些材料和其它材料的共混物、共挤出物和/或混合物也可用于获得特定节段的合适材料特性。
护套之间的过渡可以是渐缩的或开槽的,以在纵向系列的邻接护套之间提供更渐进的刚度过渡。当通过回熔焊接或层压工艺应用护套时,它们可以将底层结构粘合在一起并提供光滑的外部饰面。然后可以通过机加工或成型模具添加狭槽或其他特征部。
在支撑管100的远侧端部114处,在最远侧互锁段之后,激光切割的结构可以具有大致垂直于纵向轴线111的面115。这种面可以是另一个圆形肋、套环或其他合适的锚固结构。这种面可允许附接治疗末端、可膨胀的口或其他类似的装置。
图8示出了平坦面115作为最终独立的圆形肋出现的示例。平坦面的肋可以具有与最远侧互锁段的单个连接。在另一变型中,多个连接点可以设置在围绕轴的不同时钟位置处。
图8中所示的示例性可膨胀末端310是撑条框架,其可以具有连接到四个支撑臂316的四个远侧箍315。每个支撑臂可以在支撑管100的远侧端部114处具有到远侧面115的单个附接点,或者可以共享连接。在一个实例中,一对箍315可以逐渐变细成单个支撑臂316,使得存在相隔180度的两个连接。然后末端310可以沿着由这些连接形成的平面铰接和弯曲。
末端310可以由形状记忆允许和热定型构造,使得当从外护套或导管的远侧端部展开时它能够自膨胀。支撑臂316可具有扩大的单元开口317,这些孔开口可允许臂在围绕末端框架的纵向轴线111的相对侧上缩短和伸长,使得装置可容易地跟踪穿过弯弯曲曲的血管路径中的外部护套或导管。与没有单元317的单个撑条直接将远侧箍315与远侧面115连接的情况相比,支撑臂316撑条的分支还可以允许臂更自由地扭转和弯曲。
在许多示例中,由末端310形成的漏斗形状可以覆盖有另一个无损伤聚合物护套或膜(未示出)。末端的扩大口可改善抽吸效率、阻止不需要的流动并减小血管创伤钩在血管开口上的风险。当展开时,末端310可以匹配血管直径并且具有足够的径向力以与血管密封,或者产生足够的流动限制,使得使得大部分抽吸将应用于血液和口远侧的凝块而不是末端近侧的流体。
在另一个示例中,支撑管100可以具有与可膨胀口末端410连接的远侧面115,该可膨胀口末端可以具有组织成闭孔编织物的撑条或股线的径向阵列,如图9所示。编织物可以连接到支撑管100的平坦面115并且通向远侧端部414,如图所示,当不受约束并允许在离开外护套或导管时扩张时,形成围绕纵向轴线111的大致圆锥形或漏斗状形状。
编织物阵列可由线材制成或从形状记忆合金切割下来,使得管头可被热定形以从塌缩递送构型自膨胀至扩大的展开构型。口末端410可以粘附或以其他方式粘结在支撑管100的远侧端部114处。在一个示例中,编织末端410可以被制造成具有单个圆周接头或环形套环,以用于附接支撑管100。另选地,编织物的单独股线可以直接粘结到管的远侧面115或嵌入聚合物护套内。
在另一个示例中,可膨胀末端410可以是具有由三角形或四边形单元孔415制成的连续多边形图案的封闭单元网格阵列,这些单元孔通过网格的相邻单元的顶点互锁。该图案可以是在支架应用中常见的图案之一,其中使用微创网格来支撑和保持开放的血管通道。在一种情况下,细长四边形图案形成单元孔415,其中局部阵列峰标记共享顶点。该图案可以轴向和径向方式重复,并且相邻孔415的最远侧阵列峰可以通过无损伤弯曲远侧箍或冠412接合以标记可膨胀末端410的远侧端部414。
图10a-图10e中图解说明了利用所公开的可膨胀激光切割的支撑管100制造导管的方法,并进一步显示在图11中的流程图中。图10a示出了定位在支撑心轴10上的低摩擦衬里160。心轴通常可以是这些应用中常用的镀银铜(SPC)。另选地,可以使用特别是延展性材料(例如PEEK),其在直径上拉伸到颈缩,以便在导管组装完成后可以移除心轴。另外的心轴材料可以是尼龙涂层铜或尼龙涂层钢。
在图10b中形成激光切割的支撑管框架100,其具有连续纵向分离接缝116,从而允许支撑管的框架以弹性方式径向膨胀。在一些示例中,支撑管框架100可以由NiTi或另一种形状记忆超弹性合金切割而成,使得可以设计固态相转变来规定框架的受约束和不受约束的直径。这种膨胀允许支撑管100具有与衬里160的外径162大致相同尺寸的内径。肋118可以沿着纵向轴线111布置和变化,使得支撑管100在近侧端部112附近具有良好的可推动性和柱强度,并且在远侧端部114附近具有出色的横向柔韧性。在一些示例中,可膨胀末端310可以形成或附接在支撑管100的远侧端部114处。
在图10c中,支撑管框架100在接缝处径向膨胀并在超大号心轴20之上滑动。超大号心轴20可以是例如大于位于施加心轴10上的内衬160的外径162的至少0.005英寸。然后可以将支撑管100冷却到较低温度(理想地接近或低于马氏体结束(Mf)温度)以将支撑管材料转变到马氏体相。在另一示例中,支撑管100可以首先冷却,然后在超大号心轴20之上膨胀。如果保持冷却,马氏体的可逆固态转变可以允许支撑管100在从超大号心轴20移除时维持其膨胀形状。
另选地,可以通过在超大号心轴20周围设置一薄的外部金属套管(未显示)来消除冷却步骤。支撑管100可以在套管/超大号心轴组件上弹性膨胀,并且移除超大号心轴。套管径向地约束支撑管,使得其然后可以在位于施加心轴10上的内衬160之上滑动。当套管支撑被移除时,支撑框架100可以向下收缩到内衬160上。
如图10d所示,膨胀的支撑管100可以在位于SPC施加心轴10上的内衬160之上滑动。在不使支撑管膨胀的情况下,此步骤将产生太多摩擦而无法在支撑管和衬里之间产生可靠且可重复的交接部。一旦处于适当位置并与衬里160同心,就可以将外部聚合物层180施加在支撑管100之上(图10e)。层180可以是轴向系列的单独聚合物挤出物,其可以回熔焊接或层压在适当位置作为外护套183、184、185。施加的热可以允许外部聚合物填充支撑管的肋撑条之间的间隙部位。
图11中的方法流程图概述了类似的过程。方法步骤可通过示例性装置中的任一种或通过本文所述和本领域普通技术人员已知的合适另选形式来实现。该方法可具有所述步骤中的一些或全部,并且在许多情况下,步骤可以与下文所公开的顺序不同的顺序执行。
参考图11,方法11000可以具有将内衬围绕第一施加心轴布置的步骤11010。衬里可以是PTFE或类似的低摩擦材料。心轴的尺寸可以大约等于完成导管的所需内径。然后,步骤11020可涉及形成如本文先前所述的激光切割的支撑管结构。支撑管可以由单个连续的海波管切割而成,其可以是但不限于镍钛诺或其他形状记忆超弹性合金。切口可以形成一系列周向不连续的肋,这些不连续部分对准以形成沿支撑管的长度延伸的一个或多个纵向连续接缝,如图10a和步骤11030所示。肋可以通过在接缝的交替侧上以非线性方式围绕支撑管的肋轴向延伸并且遵循电路路线的脊连接。这种结构可以允许支撑管在一定程度上径向膨胀,同时对拉伸和压缩荷载提供良好的轴向阻力。支撑管的内径可等于或略小于低摩擦内衬的外径,因此当组装导管时,组件同心地放置。
在步骤11040中,支撑管可以通过拉伸轴向接缝而弹性膨胀,使得支撑管可以放置在第二超大号心轴上。在一些示例中,尺寸超大号心轴的尺寸可以使得支撑管框架的膨胀内径略微大于施加心轴上的内衬的外径。在一些示例中,ID可以为大于衬里的外径大约0.003英寸-0.005英寸。一旦支撑管在超大号心轴上膨胀,其就可以冷却到至少低于Af的温度,并且理想地接近或低于材料的Mf温度以引起马氏体相变。马氏体相是热力学稳定的,因此当在步骤11060中移除第二超大号心轴时,支撑管可以保持冷却并且将保持其膨胀状态。
然后,在步骤11070中,膨胀的支撑管可以在位于第一施加心轴上的之内衬上滑动并定位在其周围。然后可以将一系列不同计示硬度的外部聚合物护套回熔焊接到支撑管(步骤11080)。护套可以呈轴向系列、径向系列或某种组合。护套材料的流动可以允许它们封装支撑管的肋撑条并与内衬粘结。一旦组装完成,就可以在步骤11090中去除第一施加心轴。
本发明不必限于所描述的示例,这些示例的构型和细节可变化。术语“远侧”和“近侧”在整个前述描述中使用,并且是指相对于治疗医师的位置和方向。同样,“远侧”或“朝远侧”是指远离医师的位置或在远离医师的方向上。类似地,“近侧”或“朝近侧”是指靠近医师的位置或在朝向医师的方向上。此外,除非上下文另有明确说明,否则单数形式“一个”、“一种”和“该/所述”包括复数指代。
如本文所用,针对任何数值或范围的术语“约”或“大约”指示允许部件或元件的集合实现如本文所述的其预期要达到的目的的合适的尺寸公差。更具体地,“约”或“大约”可指列举值的值±20%的范围,例如“约90%”可指71%至99%的值范围。
在描述示例实施方案时,为了清楚起见,采用了术语。因此,并未列出所有可能的组合,并且此类变型形式对于本领域技术人员而言通常是显而易见的,并且旨在落入以下权利要求书的范围内。在不脱离本发明的范围和精神的情况下,旨在使每个术语设想其本领域技术人员理解的最广泛的含义,并且包括以类似方式操作以实现类似目的的所有技术等同物。还应当理解,提到方法的一个或多个步骤不排除存在附加的方法步骤或在那些明确标识的步骤之间的中间方法步骤。类似地,在不脱离所公开技术的范围的情况下,可按照与本文所述的顺序不同的顺序执行方法的一些步骤。
Claims (20)
1.一种柔性导管,包括支撑管、近侧端部和远侧端部,所述支撑管包括:
内衬,所述内衬围绕所述支撑管的纵向轴线设置;
轴向系列的互锁段,所述轴向系列的互锁段沿着纵向轴线形成基本上管状的轮廓,所述轴向系列的互锁段包括多个周向不连续肋;以及
一个或多个轴向接缝,所述一个或多个轴向接缝通过所述互锁段的所述周向不连续肋的对准而形成;
所述一个或多个轴向接缝允许所述支撑管径向膨胀到大于所述内衬的外径的膨胀内径。
2. 根据权利要求1所述的导管,所述互锁段各自包括:
顶半部,所述顶半部包括从相应的肋撑条延伸的一对内凹齿;和
底半部,所述底半部包括从相应的肋撑条延伸并界定接收空间的一对外凸齿。
3.根据权利要求2所述的导管,所述底半部的所述接收空间被构造成与所述顶半部的所述内凹齿交接,使得所述顶半部和所述底半部彼此并置并且在所述支撑管被组装时能够通过所述一个或多个轴向接缝彼此径向分离。
4.根据权利要求2所述的导管,所述一个或多个轴向接缝是由所述底半部的所述接收空间与所述顶半部的所述内凹齿之间的交接部的周边限定的连续间隙。
5.根据权利要求2所述的导管,所述内凹齿和所述外凸齿包括三角形或四边形形状。
6.根据权利要求2所述的导管,所述内凹齿和所述外凸齿包括L形突出部。
7.根据权利要求1所述的导管,还包括轴向连接所述肋中的每个肋的脊,所述脊遵循非线性轮廓。
8.根据权利要求1所述的导管,所述远侧端部具有大致垂直于所述纵向轴线的面,所述面被构造用于连接到导管口,所述导管口被构造用于进行血管内手术。
9.根据权利要求1所述的导管,所述一个或多个轴向接缝的轮廓遵循非线性轮廓。
10.根据权利要求1所述的导管,在第一对相邻互锁段之间测量的第一段节距与在第二对相邻互锁段之间测量的第二段节距不同。
11. 一种用于导管轴的柔性支撑管,所述支撑管包括:
激光切割的撑条框架,所述撑条框架包括沿着所述支撑管的纵向轴线分布的基本上圆形的肋,所述肋包括围绕所述支撑管的圆周的一个或多个周向不连续部分;以及
一个或多个轴向接缝,所述一个或多个轴向接缝由所述肋中的所述周向不连续部分的对准形成,所述一个或多个轴向接缝被构造成允许所述支撑管的径向膨胀;
所述撑条框架的所述肋沿着纵向轴线形成具有基本上管状的轮廓的轴向系列的互锁段;
所述互锁段各自包括:
顶半部,所述顶半部包括从相应的肋撑条延伸的一对内凹齿;和
底半部,所述底半部包括从相应的肋撑条延伸并界定接收空间的一对外凸齿。
12.根据权利要求11所述的支撑管,所述互锁段被对准,使得所述顶半部的每对内凹齿和所述底半部的每对外凸齿均彼此并置,并且当所述支撑管被组装时能够通过所述一个或多个轴向接缝径向分离。
13.根据权利要求12所述的支撑管,所述一个或多个轴向接缝是由所述底半部的所述外凸齿与所述顶半部的所述内凹齿之间的交接部的周边限定的连续间隙。
14.根据权利要求12所述的支撑管,所述一个或多个轴向接缝具有非线性轮廓。
15.根据权利要求12所述的支撑管,每个顶半部的所述内凹齿和每个底半部(104)的所述外凸齿包括平行于所述支撑管的所述纵向轴线的突出部。
16.根据权利要求12所述的支撑管,所述内凹齿与所述外凸齿的接合限制所述支撑管的轴向膨胀。
17.根据权利要求11所述的支撑管,在第一对相邻互锁段之间测量的第一段节距与在第二对相邻互锁段之间测量的第二段节距不同。
18.根据权利要求11所述的支撑管,肋撑条的第一肋宽度不同于另一肋撑条的第二肋宽度。
19.一种用于制造导管的方法,所述方法包括以下步骤:
将内衬围绕第一施加心轴布置;
形成支撑管,所述支撑管包括轴向接缝,所述轴向接缝允许所述支撑管的径向膨胀;
通过将所述支撑管定位在基本上管状的第二超大号心轴上来使所述支撑管膨胀以拉伸所述轴向接缝,所述超大号心轴的尺寸被设定成具有的外径略微大于所述内衬的外径;
将所述支撑管冷却到低于奥氏体结束温度的温度;
从所述支撑管中移除所述第二超大号心轴;
将所径向膨胀的支撑管围绕所述内衬和所述第一施加心轴定位;
将多个外部聚合物护套回熔焊接或层压到所述支撑管;以及
当所述内衬和所述支撑管已被所述外部聚合物层粘结时,移除所述第一施加心轴。
20.根据权利要求19所述的方法,还包括激光切割所述支撑管以形成多个周向不连续肋并且对准所述周向不连续部分以形成所述轴向接缝的步骤。
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2021
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- 2022-02-22 JP JP2022025360A patent/JP2022129387A/ja active Pending
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US20240091492A1 (en) | 2024-03-21 |
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KR20220121197A (ko) | 2022-08-31 |
JP2022129387A (ja) | 2022-09-05 |
US20220265963A1 (en) | 2022-08-25 |
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