CN109069790A - 导管轴及相关装置、系统和方法 - Google Patents

导管轴及相关装置、系统和方法 Download PDF

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CN109069790A
CN109069790A CN201680081225.1A CN201680081225A CN109069790A CN 109069790 A CN109069790 A CN 109069790A CN 201680081225 A CN201680081225 A CN 201680081225A CN 109069790 A CN109069790 A CN 109069790A
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理查德·奎克
布莱恩·J·科克斯
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Inari Medical Inc
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    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M25/00—Catheters; Hollow probes
    • A61M25/0043—Catheters; Hollow probes characterised by structural features
    • A61M25/0045—Catheters; Hollow probes characterised by structural features multi-layered, e.g. coated
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M25/00—Catheters; Hollow probes
    • A61M25/0021—Catheters; Hollow probes characterised by the form of the tubing
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M25/00—Catheters; Hollow probes
    • A61M25/0043—Catheters; Hollow probes characterised by structural features
    • A61M2025/0059—Catheters; Hollow probes characterised by structural features having means for preventing the catheter, sheath or lumens from collapsing due to outer forces, e.g. compressing forces, or caused by twisting or kinking
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M25/00—Catheters; Hollow probes
    • A61M25/0043—Catheters; Hollow probes characterised by structural features
    • A61M25/0054—Catheters; Hollow probes characterised by structural features with regions for increasing flexibility

Abstract

本文公开了导管轴和相关装置，系统和方法。根据本公开的实施例的代表性导管包括大致管状的外部结构和由外部结构围绕的内部结构。内部结构围绕导管内腔。内部结构包括重叠边缘，使得当导管沿其纵向轴线弯曲时，重叠边缘相对于彼此移动。

Description

导管轴及相关装置、系统和方法
相关申请交叉引用
本申请要求于2015年12月18日提交的标题为“CATHETER SHAFT AND ASSOCIATEDDEVICES，SYSTEMS，AND METHODS”的美国临时申请号62/269,372的优先权，其内容通过引用整体并入本文。
技术领域
本技术总体上涉及导管。更具体地说，本技术涉及导管轴结构。
背景技术
已经开发了各种各样的用于血管内使用的医疗装置。例如，导管通常用于帮助在患者的解剖结构内导航和/或治疗。由于导管性能的机械、生物和化学要求之间的妥协，许多现有的导管是由两种或更多种不同材料组成的复合材料，以便利用不同材料的独特性质。例如，常见的复合导管结构包括(1)由提供纵向刚性以抵抗扭结的材料制成的外护套和(2)具有低摩擦系数的化学惰性内表面衬垫(通常为氟聚合物)以易于通过轴腔输送一个或多个组件。然而，内衬材料比用于外护套的材料柔性明显较低，因此极大地影响复合导管轴的柔性。例如，通常用作内表面衬垫的材料的弹性模量约为70,000psi，而普通外套材料的弹性模量约为2,900psi。尽管一些传统的导管由低硬度聚合物制成(例如非常软的)，但是这种导管通常几乎没有抗扭结性。因此，需要一种具有改进的柔性的抗扭结导管轴。
附图说明
图1A是根据本技术配置的导管轴的一部分的侧视图，以未受应力状态示出。
图1B是沿着线1B-1B截取的图1A中所示的导管轴的横截面图。
图1C是根据本技术配置的图1A-1B所示的导管轴的内部结构的分离立体图。
图1D是图1B中所示的横截面导管轴的一部分的放大图。
图2A是图1A-1C中所示的导管轴的等轴视图，其显示为沿着弯曲轴弯曲。
图2B是图2A中所示的导管轴的侧视图。
图2C是图2A和2B中所示的导管轴的等轴前视图。
图2D是沿着图2C中所示的视图的线2D-2D截取的图2A-2C中所示的导管轴的横截面图。
图2E是图2D中所示的横截面导管轴的一部分的放大图。
图2F是图2D中所示的横截面导管轴的一部分的放大图。
图3A是根据本技术的另一实施例配置的导管轴的等轴视图，示出了沿其轴线弯曲的导管轴。
图3B是图3A中所示的导管轴的侧视图。
图4A是根据本技术配置的图3A-3B所示的导管轴的内部结构的分离等轴视图，以未受应力状态示出。
图4B是图4A中所示的内部结构的分离侧视图。
图4C是根据本技术配置的图4A-4B中所示的内部结构的隔离区段。
具体实施例
本技术涉及导管和相关联的制造方法。下面参照图1A-4C描述根据本技术的导管装置、系统和方法的几个实施例的具体细节。在一个实施例中，本技术包括由管状外部结构和由外部结构围绕的螺旋内部结构组成的导管轴。内部结构可由围绕中心纵向轴线缠绕的材料条带形成，使得条带的边缘重叠以形成连续的管状壁。在一些实施例中，仅条带的暴露部分限定了连续管状壁的外表面。暴露部分可以结合到外部结构，而条带的剩余部分保持相对于暴露部分自由滑动。因此，本技术的导管轴比利用由连续管制成的内部结构的可比的轴具有更显著的柔性。
I.导管轴的选定实施例
图1A和1B分别是根据本技术配置的复合导管轴100(在本文中也称为“轴100”)的一部分的侧视图和横截面图，该复合导管轴100以未受应力状态示出。一起参考图1A-1B，导管轴100包括大体管状的侧壁102，该侧壁102限定穿过其中的内腔104。内腔104构造成可滑动地容纳并促进一个或多个医疗装置穿过其中，例如导管、套管、接入端口、导丝、植入物、输注装置、支架和/或支架移植物、血管内堵塞装置、凝块回收器、支架回收器、植入式心脏瓣膜以及其他合适的医疗装置和/或相关联的输送系统。另外，内腔104可以被配置为接收穿过其中的一种或多种流体，例如不透射线染料、盐水、药物等。
内腔104的尺寸可以根据轴100的期望特性而变化。例如，在一些实施例中，轴100可具有在约0.01英寸与约0.5英寸之间的内径(例如内腔直径)，而在一些实施例中介于约0.2英寸至约0.4英寸之间。虽然图1A-1B所示的轴100具有大致圆形(例如圆形)的横截面形状，但应该理解，轴100可以包括其他横截面形状或形状组合。例如，轴100的横截面形状可以是椭圆形、长圆形(oblong)、矩形、正方形、三角形、多边形和/或任何其它合适的形状和/或形状的组合。
如图1A-1B所示，轴100的侧壁102包括外部结构114和由外部结构114围绕的内部结构112。外部结构114的端部已经在图1A-1B移除以更好地示出内部结构112的结构特征；通常，外部结构114沿内部结构112的整个长度围绕内部结构112。在一些实施例中，外部结构114可以是细长的聚合物管。用于外部结构114的合适材料包括(聚醚嵌段酰胺)、聚甲醛(POM)、聚对苯二甲酸丁二醇酯(PBT)、聚醚嵌段酯、聚醚嵌段酰胺(PEBA)、氟化乙烯丙烯(FEP)、聚乙烯(PE)、聚丙烯(PP)，聚氯乙烯(PVC)、聚氨酯、聚四氟乙烯(PTFE)、聚醚醚酮(PEEK)、聚酰亚胺、聚酰胺、聚苯硫醚(PPS)、聚苯醚(PP0)、聚砜、尼龙、全氟(丙基乙烯醚)(PFA)、聚醚酯、铂、聚合物/金属复合材料等，或其混合、混合物或组合。
图1C是没有外部结构114的内部结构112的分离的等轴视图。如图1A-1C所示，内部结构112可以是围绕中心纵向轴线A缠绕的材料的单个条带113，从而条带113的边缘重叠以形成在纵向方向上具有不连续外表面125的连续/邻接(例如，无间隙)管状壁。内部结构112和/或条带113可以由具有低摩擦系数的材料制成，例如含氟聚合物和/或润滑聚合物(例如高密度聚乙烯(HDPE)，聚四氟乙烯(PTFE))，和/或四氟乙烯与全氟烷基醚如全氟烷氧基(PFA)、全氟丙基乙烯基醚和/或全氟甲基乙烯基醚的共聚物。其他合适的材料可以包括PEEK、PE、PP或四氟乙烯、FEP等的共聚物等。在本技术的许多实施例中，内部结构材料具有比外部结构材料更高的熔点。
如图1D中轴100的放大截面图所示，缠绕条带113具有限定俯冲带(subductionzone)的重叠区域122和非重叠区域140。在图1A-1D所示的实施例中，重叠区域122的宽度沿轴100的长度大致相同。在其他实施例中，重叠区域122的宽度可沿轴100的长度变化。在代表性实施例中，当轴100处于无应力状态，条带113的约50％或更少被覆盖。这种构造避免了在给定的纵向上逐渐增加内部结构112的厚度。在其他实施例中，重叠的百分比可以大于50％。重叠量(或者螺旋条带的间距)可以沿着轴的长度变化以产生不同和/或变化刚度的区域。
如图1D所示，重叠区域122包括条带113的外部部分124和条带113的内部部分126，其位于外部部分124的径向内侧。外部部分124、内部部分126和非重叠区域140一起限定了条带113的宽度w。另外，内部结构112的厚度可以是外部部分124和内部部分126的厚度的总和(分别标记为t0和t1)，或两倍于条带113的厚度。
外部部分124可以具有径向向外面向的外表面124a和与外表面124a相对并且面向内腔104的内表面124b。内部部分126具有径向向外面向的外表面126a和与外表面126a相对并且面向内腔104的内表面126b。在图1A-1D所示的实施例中，外部部分124的外表面124a沿外部部分124的全部或部分长度被结合或以其他方式固定到外部结构114。轴100可包括在外部部分124和外部结构114的相邻匝之间的间隙118。外部部分124的内表面124b沿其全部或部分相应长度邻接内部部分126的外表面126a。因为条带113由具有低摩擦系数的材料制成，外部部分124的内表面124b可接触内部部分126的外表面126a，但在轴100沿着它的轴线A弯曲时，仍保持相对于外表面126a滑动的能力(反之亦然)。另外，如图1D所示，内部部分126的内表面126b可限定轴内腔104。
图2A-2C分别是根据本技术的导管轴100的等轴视图、侧视图和等轴前视图，其示出了沿着轴线A弯曲(例如弯曲时的弯曲轴线)。图2D是沿着图2C所示的视图的线2D-2D截取的图2A-2C中所示的导管轴的横截面图，以及图2E和2F是图2D中所示的横截面导管轴100的一部分的放大图。一起参照图2A-2F，当轴100弯曲或变形时，外部结构114弹性变形并且迫使固定的外部部分124随其移动和弯曲。随着外部部分124移动，内部部分126沿着外部部分124的内表面124b滑动。沿着经受张力的轴100的部分，重叠区域122的宽度减小，如图2E所示。沿着轴100的经受压缩力的部分，当外部部分124相对于内部部分126消失时，重叠区域122的宽度增加，如图2F所示。
本技术的导管轴100提供了优于现有导管的几个优点。例如，与由相同材料制成并具有相同的厚度的连续管相比，内部结构112的螺旋或螺旋形几何形状以及内部结构112与外部结构114的中断结合大大增加了内部结构112的总体柔性。如此，本技术的导管轴100比传统导管轴明显更灵活。例如，在一些实施例中，轴100的弯曲刚度可以比可比的复合导管轴的弯曲刚度小25％(例如，具有相同外部结构和由相同材料制成的连续管所制成的内部结构的轴，具有相同的厚度和相同的内径的轴)。在一些实施例中，弯曲刚度可以比可比的复合导管的弯曲刚度小约30％至约60％。在一些实施例中，内部结构可以提供小于约50％的复合导管的总弯曲刚度，并且在其他实施例中小于约25％的复合导管的总弯曲刚度。这种改进的灵活性对于较大直径的导管(假设壁厚不因直径而变化)如引导导管是最引人注目的。对于给定的弯曲半径和壁厚，具有较大ID导管的壁比小ID导管的壁受到更大的应变。
II.选定的制造方法
在根据本技术制造导管轴的一个实施例中，提供了材料条带。在一些实施例中，条带可以由期望的内部结构材料例如PTFE制成。条带可以是PTFE带，纵向切割的PTFE管(下面更详细地描述)，或者带状的其他聚合物结构。例如，在一些实施例中，条带通过沿着围绕管的纵向轴线的螺旋路径分裂聚合物管的壁来构造。在任何前述实施例中，材料条带可以围绕芯轴缠绕。在代表性实施例中，条带从近端缠绕到远端，使得条带的自由边缘或台阶在内腔内面向远侧。条带可以以这种方式缠绕，以为通过其中输送的一个或多个装置提供通过内腔的更光滑的路径。在其他实施例中，条带可以从其远端缠绕到其近端。
条带可以缠绕成具有期望的螺距角(例如，条带的连续匝之间的距离)。螺距角影响所得缠绕结构的柔性，因为螺距角影响轴的每单位长度的重叠区域的量，这又影响(最终)经受弯曲应力的结合条带的宽度。在一些实施例中，实现50％覆盖的最大螺距角可以由方程式最大螺距角＝tan-1(2πD/w)来控制，并且实现不重叠的最小螺距角可以由方程式最小螺距角＝tan-1(πD/w)来控制，其中D是轴的期望内径，w是材料条带的宽度。
一旦条带根据需要围绕芯轴缠绕，则将材料管(例如，通常用于外部结构的聚合物)置于缠绕条带上方。接下来，可将热收缩管(例如含氟聚合物)置于管上。然后将该组件(例如芯轴、缠绕条带、管和热收缩管)从其远端逐渐加热到其近端(或反之亦然)以使管与条带融合。组件吸收的卡路里量和卡路里转移到芯轴的速度将取决于组件的几何形状(例如，组件的长度、组件的直径、使用的材料的厚度等)。温度可以足够高以收缩热收缩管并且将管材的温度提高到高于其玻璃化转变温度(例如，在约380°F和约440°F之间)，但仍足够低以致不影响管材的硬度并影响其所得的分子量(从而改变所得外部结构的机械性能)。而且，可以监测热施加的持续时间，以避免太长时间或施加太高的温度，这可能导致管材在条带的重叠部分之间流动并进入内腔，由此提高在导管内腔内部的摩擦系数。另外，可以选择芯轴材料以提供散热器以快速从熔化的管中移除热量并在管材在重叠之间流动之前将其冻结。例如，在一些实施例中，芯轴是钢管，并且管的壁厚可以改变以增加或减少传热速率。一旦组件冷却后，热收缩管可以被移除并且新形成的复合轴可被从芯轴移除。
在本文公开的任何装置和方法中，内部结构由聚合物管(例如，PTFE管)形成，该聚合物管在平行于管的纵向轴线的方向上被切成条带。那么条带的宽度是(πD)，其中D是管直径。条带的厚度是管的壁厚。另一种从管道生成条带的方法是螺旋切割管道。那么条带的最大宽度是(πD)/(tanθ)，其中θ是螺旋线与管轴的角度。
在切割管之前，管可以仅在其外表面上蚀刻以增加管的外表面和可以粘合到管的外表面的其他聚合物(即，外部结构材料)之间的摩擦系数。通过在挤压期间将管浸入液态蚀刻剂中作为在线工艺，或者在挤压后作为分批工艺，可用强碱(例如氢氧化钠，氢氧化钾，钠/氨等)蚀刻管。后一种方法包括在浸入之前堵塞PTFE管的端部，或者将开口端保持在液体蚀刻剂外面。这样，聚合物管道材料的只有一个表面被蚀刻，而另一个表面未被蚀刻。
III.附加实施例
图3A和3B分别是根据本技术的另一实施例配置的导管轴300(在本文中也称为“轴300”)的等轴视图和侧视图，示出了沿其轴A弯曲的导管轴300。如图3A和3B所示，轴300可以包括外部结构314和由外部结构314围绕的内部结构312。图4A和图4B是与轴300隔开的内部结构312的侧视图和等轴视图。在图3A-4B所示的实施例中，内部结构312由多个重叠片段315例如环形成。图4C中示出了分离的片段315。片段315可以具有大致圆柱形或圆锥形的形状。另外，参照图4B，各个片段315可以具有具有内径的外部326和具有适配在外部326的内径内的外径的内部326。片段315可以如图4B所示布置，使得一个片段315的内部分326被接收在直接相邻的片段315的外部324内。内部326因此以与上面关于图1A-2F所述的实施例类似的方式与外部324重叠。外部326固定到外部结构314，但是内部326可以在外部326的内表面上滑动。结果，轴300可被预期为具有与上面关于轴100所讨论的类似的优点。
IV.例子
以下实例说明本技术的若干实施例：
1.一种导管，包括：
大致管状的外部结构；和
由外部结构围绕且围绕导管内腔的内部结构。
2.实例1的导管，其中内部结构包括重叠边缘。
3.实例1或实例2的导管，其中内部结构在纵向上不连续。
4.实例1-3中任一项所述的导管，其中该内部结构具有与其自身的自由滑动接口。
5.实例1-4中任一项所述的导管，其中该内部结构提供小于50％的导管的总弯曲刚度。
6.实例1-5中任一项所述的导管，其中该内部结构具有在导管弯曲期间切向滑动的部分。
7.一种导管，包括
大致管状的外部结构，该外部结构具有外表面和内表面；和
由外部结构围绕的内部结构，内部结构具有松弛状态和应力状态，并且其中-
内部结构由围绕中心纵向轴线螺旋缠绕的材料条带构成，以形成限定内腔的大致管状构件，其中条带具有外表面和内表面，
条带的第一部分沿着条带的纵向轴线与条带的第二部分重叠，
外表面的仅一部分结合到外部结构的内表面，
当导管沿其纵向轴线弯曲时，第二部分构造成相对于第一部分滑动。
8.实例7的导管，其中内部结构包括重叠边缘。
9.实例7或实例8所述的导管，其中内部结构在纵向方向上不连续。
10.实例7至9中任一项所述的导管，其中内部结构提供小于50％的导管的总弯曲刚度。
11.实例7到10中任一项所述的导管，其中第一部分在导管弯曲期间相对于第二部分切向滑动。
12.实例7-11中任一项所述的导管，其中材料条带由已经在平行于管的纵向轴线的方向上切割的聚合物管形成。
13.实例7-11中任一项所述的导管，其中材料条带由已沿螺旋方向切割的聚合物管形成。
14.实例7-13中任一项所述的导管，其中聚合物管具有蚀刻的外表面和未被蚀刻的内表面。
14.实例7-13中任一项所述的导管，其中聚合物管是PTFE管。
V.结论
本技术的许多实施例可以用于访问或治疗位于曲折和狭窄血管中的目标，诸如神经血管系统、肺血管系统、冠状血管系统和/或外周血管系统中的某些位点。本技术的导管轴也可以适用于消化系统、软组织和/或任何其他用于医疗用途的生物体的插入。
应该理解，根据本技术的附加实施例，参照图1A-4C描述的实施例的具体元件、子结构、优点、用途和/或其他特征可以适当地相互交换、替换或以其他方式彼此配置。例如，单个导管轴可以包括具有螺旋部分(如图1A-2F所示)和片段部分(如图3A-4C所示)的内部结构。因此，本领域的普通技术人员将相应地理解，该技术可以具有带有附加元件的其他实施例，或者该技术可以具有其他实施例，而没有参考图1A-4C在上面示出和描述的几个特征。例如，本技术的导管可以与任何以下所公开的凝块治疗装置和相关装置、系统和方法一起使用：2014年6月9日提交的美国专利申请号14/299,933以及2013年3月15日提交的美国专利申请号13/843,742以及2015年6月9日提交的美国专利申请14/735,110，所有这些专利申请的全部内容通过引用并入本文。另外，在一些实施例中，本技术的导管轴可以包括附加的结构和/或层。例如，在特定实施例中，轴包括位于内部结构和外部结构之间的附加结构或材料。而且，在特定实施例中，轴包括多于一个的条带。

Claims (6)

1.一种导管，包括：
大致管状的外部结构；和
由所述外部结构围绕且围绕导管内腔的内部结构，其中所述内部结构包括重叠边缘。
2.一种导管，包括：
大致管状的外部结构；和
由所述外部结构围绕的内部结构，其中所述内部结构在纵向方向上不连续。
3.一种导管，包括：
大致管状的外部结构；和
由所述外部结构围绕的内部结构，其中所述内部结构具有与其自身的自由滑动接口。
4.一种导管，包括：
大致管状的外部结构；和
由所述外部结构围绕的最内部结构，其中所述最内部结构提供小于50％的所述导管的总弯曲刚度。
5.一种导管，包括
大致管状的外部结构；和
由所述外部结构围绕的内部结构，其中所述内部结构具有在弯曲所述导管期间切向滑动的部分。
6.一种导管，包括
大致管状的外部结构，所述外部结构具有外表面和内表面；和
由所述外部结构围绕的内部结构，所述内部结构具有松弛状态和应力状态，并且其中-
所述内部结构由围绕中心纵向轴线螺旋缠绕的材料条带构成，以形成限定内腔的大致管状构件，其中所述条带具有外表面和内表面，
所述条带的第一部分沿着所述条带的纵向轴线与所述条带的第二部分重叠，
仅所述外表面的一部分结合到所述外部结构的所述内表面，
当所述导管沿其纵向轴线弯曲时，所述第二部分构造成相对于所述第一部分滑动。
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US20180361116A1 (en) 2018-12-20
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WO2017106877A1 (en) 2017-06-22
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