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CN108211084A - 用于改善抗扭结性的分层管 - Google Patents

用于改善抗扭结性的分层管 Download PDF

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CN108211084A
CN108211084A CN201711394822.2A CN201711394822A CN108211084A CN 108211084 A CN108211084 A CN 108211084A CN 201711394822 A CN201711394822 A CN 201711394822A CN 108211084 A CN108211084 A CN 108211084A
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polymer layer
cured
layer
method described
catheter shaft
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CN108211084B (zh
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C.T.比克勒
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Biosense Webster Israel Ltd
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Biosense Webster Israel Ltd
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    • B29—WORKING OF PLASTICS; WORKING OF SUBSTANCES IN A PLASTIC STATE IN GENERAL
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    • A61L—METHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
    • A61L2420/00—Materials or methods for coatings medical devices
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    • A61M25/00—Catheters; Hollow probes
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Abstract

本发明题为“用于改善抗扭结性的分层管”。导管杆通过将第一聚合物层形成到柔性内部线上同时维持内部芯为固态以及固化该第一聚合物层来制造，其中经固化的第一聚合物层不与内部芯粘合并且在杆屈曲时可在该内部芯上滑动。可将第二聚合物层形成到第一聚合物层之上，并且当杆弯曲时可在该第一聚合物层上滑动。

Description

用于改善抗扭结性的分层管
版权声明
本专利文献的公开内容的一部分包括受版权保护的材料。版权所有者不反对任何人照专利和商标办公室专利文件或记录原样复制本专利文件或专利公开内容，但除此之外版权所有者保留所有相关的版权。
背景技术
1.技术领域
本发明涉及用于执行身体的腔或管的内部的医学检查的器械。更具体地，本发明涉及通过将流体材料施加到表面或表面的一部分的过程来构造医疗导管。
2.相关领域的描述
绘制并且消融具有电传导异常的受检者中的心内膜组织是常见的。用细长导管执行规程，该导管具有纵向延伸穿过该导管的管腔。在美国专利No.5,993,462中所述的一种技术涉及经由管腔将芯线插入到导管中。芯线包括预成型区域。此类导管包括近侧节段，该近侧节段足够刚性以在将芯线设置在近侧节段内时将芯线拉直。导管的远侧节段比近侧节段显著更具柔性。
可偏转导管广泛用于多种应用。在电生理学领域。然而，由于其固有的柔性和有限的抗扭结性，导管可能难以按所期望的一样精确控制。增加抗扭结性的常规方法包括：增加壁厚、用线圈加固壁、用多管腔布置替换大开口管腔或改变材料，使得其可更容易拉伸和弯曲。
发明内容
根据本发明的公开实施方案，导管杆使用未化学粘合在一起的材料的多个膜铸塑层、挤出层或共挤出层来构造。虽然多个层的机械接触极好，但是当该构造弯曲时，它们能够相对于彼此滑动，这使得管更抗扭结。
根据本发明的实施方案提供了制造导管杆的方法，该方法通过将第一聚合物层形成到柔性内部芯上同时维持内部芯处于固态以及固化该第一聚合物层来实施，其中经固化的第一聚合物层不与内部芯粘合并且在内部芯屈曲时可在该内部芯上滑动。
根据本发明的一个方面，其中形成第一聚合物层是挤出的。
根据该方法的又一方面，第一聚合物层是膜铸塑的。
该方法的另外的方面通过将第二聚合物层形成到经固化的聚合物第一层上以及固化该第二聚合物层来实施，其中经固化的第二聚合物层不与经固化的第一聚合物层粘合并且在内部芯屈曲时可在该第一聚合物层上滑动。
根据该方法的附加方面，第二聚合物层是挤出的。
根据该方法还有的另一方面，第二聚合物层是膜铸塑的。
根据该方法的又一方面，经固化的第一聚合物层与经固化的第二聚合物层之间的动摩擦系数不超过0.5。
根据该方法还有的另一方面，经固化的第一聚合物层和经固化的第二聚合物层由相同材料组成。
根据该方法的附加方面，经固化的第一聚合物层和经固化的第二聚合物层由聚酰亚胺组成。
根据该方法的另外的方面，经固化的第一聚合物层和经固化的第二聚合物层由不同材料组成。
根据该方法的另一方面，经固化的第一聚合物层和经固化的第二聚合物层中的一种为超高分子量聚乙烯，并且经固化的第一聚合物层和经固化的第二聚合物层中的另一种为聚醚嵌段酰胺。
根据该方法的一个方面，内部芯包含金属编织物。
另外根据本发明的实施方案提供了导管杆，该导管杆具有柔性内部芯、形成到柔性内部芯上的第一聚合物层以及形成到第一聚合物层上的第二聚合物层，其中当柔性内部芯屈曲时第一聚合物层可在柔性内部芯上滑动并且可在第二聚合物层上滑动。
附图说明
为更好地理解本发明，就本发明的详细说明以举例的方式做出参考，该详细说明应结合以下附图来阅读，其中类似的元件用类似的附图标号来表示，并且其中：
图1是根据本发明的实施方案的医疗导管的示意图；
图2是根据本发明的实施方案的图1中示出的导管的杆的剖视图；以及
图3是根据本发明的实施方案的图1中示出的导管的杆的部分的两个示意性纵向节段的组。
具体实施方式
为了提供对本发明的各种原理的全面理解，在下文的描述中列出了许多具体细节。然而，对于本领域的技术人员而言将显而易见的是，并非所有这些细节都是实践本发明所必需的。在这种情况下，未详细示出熟知的电路、控制逻辑部件以及用于常规算法和过程的计算机程序指令的细节，以免不必要地使一般概念模糊不清。
以引用方式并入本文的文献将被视作本申请的整体部分，不同的是，就任何术语在这些并入文件中以与本说明书中明确或隐含地作出的定义矛盾的方式定义而言，应仅考虑本说明书中的定义。
现在转向附图，首先参见图1，其为根据本发明的实施方案的医疗导管10的示意图。导管10包括细长杆12，该杆具有相对刚硬的近侧节段14、相对于近侧节段14相对柔性的远侧节段16以及中间节段18。为了执行绘制、消融或其它期望功能，将一个或多个电极或其它装置安装在远侧节段16上，并且控制手柄20位于杆12的近侧节段14处。提供输注管22以通过杆12的管腔(未示出)注入流体。鲁尔(luer)针座24安装在输注管22的近侧端部，以便于将流体注入到导管10中。
现在参见图2，其为根据本发明的实施方案的杆12(图1)的剖视图。如下面的详细描述中所述，杆通过挤出或共挤出热塑性材料来构造。在所描绘的实施方案中，杆12包括被相对柔软的内部挤出物34(其通过金属编织物36被抽拉)围绕的管腔26、管腔28、管腔30、管腔32。虽然示出了4个管腔，但是取决于预期的应用，导管可包括更多或更少的管腔。
内部挤出物34和编织物36被一系列层围绕。图2的实施例中示出相应的外层38、中间层40和内层42；然而，杆12可用更多或更少个层来构造。这些层使用常规的螺杆挤出机(优选地具有筒冷却系统)以连续的挤出操作来施加，以获得良好的混合效率和熔融均匀性以及避免浪涌效应。处理这些问题是挤出领域所熟知的，并且本文不另外处理这些问题。另选地，这些层可与内部挤出物34共挤出。
重要的是，层38、层40、层42以及内部挤出物34不彼此粘合，但它们在物理上紧密接近；实际上彼此接触。该要求使层38、层40、层42以及内部挤出物34能够在杆屈曲时在彼此上滑动。层38、层40、层42可由相同的材料(例如，聚酰亚胺或热塑性塑料，诸如聚对苯二甲酸乙二酯(PET)、聚氨酯或尼龙TM)构成。如果使用热塑性塑料，则可通过保持每个连续的内层低于当前挤出的外层的熔点来防止层彼此粘合。当使用相同材料时，如果内层是冷的并且外部挤出物在刚好能够使材料流动的温度下放置，则可避免粘合。在那种情况下，外部挤出物一接触内层就立即冷却，并且不会熔融到内部芯中并形成粘合。当膜铸塑与聚酰亚胺一起使用时，如果内层是经固化的，则其不与外层产生粘合。
另选地，杆12可通过不彼此粘合的不同材料(例如，超高分子量聚乙烯(UHMWPE)和聚醚嵌段酰胺，诸如Pebax)的交替层来构建建立。
不管所选择的材料如何，可期望在相邻的层38、层40、层42之间以及在层38与内部挤出物34之间存在低的动摩擦系数。0.5的摩擦系数是令人满意的。
现在参见图3，其为根据本发明的实施方案的杆12的部分的示意性纵向节段。在附图的上部部分中，杆12被延长。在杆12的一侧，外层38中的标记物44、中间层40中的标记物46和内层42中的标记物48彼此对齐，并且与内部挤出物34中的参考标记物50对齐。在杆12的相对侧，外层38中的标记物52、中间层40中的标记物54和内层42中的标记物56也与参考标记物50对齐。
在附图的下部部分中，杆12处于围绕枢转点58以将近90度的角度屈曲的状态。标记物44、标记物46、标记物48以及标记物52、标记物54、标记物56不再彼此对齐，也不再与参考标记物50对齐，因为层38、层40、层42在彼此上发生滑动，并且就内层42而言，其在内部挤出物34上发生滑动。在杆12的右侧处，标记物44、标记物46、标记物48现在相对于标记物50(大体在箭头60所指示的方向上朝枢转点58)发生轴向位移。外层38中的标记物44距参考标记物50具有最大位移，其中标记物46、标记物48的位移依次减小。在杆12的相对侧上，如箭头62所指示，标记物52、标记物54、标记物56也相对于标记物50大体远离枢转点58发生位移，但是在相反方向上。外层38中的标记物52具有距参考标记物50最大位移，其中标记物54、标记物56的位移依次减小。
三个层层38、层40、层42中，层38处于最大压缩。层相对于彼此的移动防止了杆12紧紧地扭结，即使在屈曲的情况下。
另选实施方案。
继续参见图2和图3，在该实施方案中，层38、层40、层42通过本领域中已知的聚合物溶液铸塑或膜铸塑的过程形成到内部挤出物34上，该内部挤出物现在用作芯轴。第一实施方案中使用的相同材料是合适的，因为它们具有期望的润滑性和硬度特性。此外，通过将外层膜铸塑到经固化的内层上来防止层彼此粘合。
本领域技术人员应当理解，本发明不限于上文具体示出和描述的内容。相反，本发明的范围包括上文所述各种特征的组合与子组合两者，以及本领域的技术人员在阅读上述描述时可想到的未在现有技术范围内的上述各种特征的变型和修改。

Claims (21)

1.一种制造导管杆的方法，包括以下步骤：
将第一聚合物层形成到柔性内部芯上，同时维持所述内部芯处于固态；以及
固化所述第一聚合物层，其中所述经固化的第一聚合物层不与所述内部芯粘合，并且在所述内部芯屈曲时可在所述内部芯上滑动。
2.根据权利要求1所述的方法，其特征在于，形成第一聚合物层通过挤出来执行。
3.根据权利要求1所述的方法，其特征在于，形成第一聚合物层通过膜铸塑来执行。
4.根据权利要求1所述的方法，其特征在于，还包括以下步骤：
将第二聚合物层形成到所述经固化的聚合物第一层上；以及
固化所述第二聚合物层，其中所述经固化的第二聚合物层不与所述经固化的第一聚合物层粘合，并且在所述内部芯屈曲时可在所述内部芯上滑动。
5.根据权利要求4所述的方法，其特征在于，形成第二聚合物层通过挤出来执行。
6.根据权利要求4所述的方法，其特征在于，形成第二聚合物层通过膜铸塑来执行。
7.根据权利要求4所述的方法，其特征在于，所述经固化的第一聚合物层与所述经固化的第二聚合物层之间的动摩擦系数不超过0.5。
8.根据权利要求4所述的方法，其特征在于，所述经固化的第一聚合物层和所述经固化的第二聚合物层由相同材料组成。
9.根据权利要求8所述的方法，其特征在于，所述经固化的第一聚合物层和所述经固化的第二聚合物层由聚酰亚胺组成。
10.根据权利要求4所述的方法，其特征在于，所述经固化的第一聚合物层和所述经固化的第二聚合物层由不同材料组成。
11.根据权利要求10所述的方法，其特征在于，所述经固化的第一聚合物层和所述经固化的第二聚合物层中的一种为超高分子量聚乙烯，并且所述经固化的第一聚合物层和所述经固化的第二聚合物层中的另一种为聚醚嵌段酰胺。
12.根据权利要求1所述的方法，其特征在于，所述内部芯包含金属编织物。
13.一种导管杆，包括：
柔性内部芯；
第一聚合物层，所述第一聚合物层形成到所述柔性内部芯上；以及
第二聚合物层，所述第二聚合物层形成到所述第一聚合物层上，其中在所述柔性内部芯屈曲时，所述第一聚合物层可在所述柔性内部芯上滑动并且可在所述第二聚合物层上滑动。
14.根据权利要求13所述的导管杆，其特征在于，所述第一聚合物层和所述第二聚合物层通过挤出形成。
15.根据权利要求13所述的导管杆，其特征在于，所述第一聚合物层和所述第二聚合物层通过膜铸塑形成。
16.根据权利要求13所述的导管杆，其特征在于，所述第一聚合物层与所述第二聚合物层之间的动摩擦系数不超过0.5。
17.根据权利要求13所述的导管杆，其特征在于，所述第一聚合物层和所述第二聚合物层由相同材料组成。
18.根据权利要求17所述的导管杆，其特征在于，所述第一聚合物层和所述第二聚合物层由聚酰亚胺组成。
19.根据权利要求13所述的导管杆，其特征在于，所述第一聚合物层和所述第二聚合物层由不同材料组成。
20.根据权利要求19所述的导管杆，其特征在于，所述第一聚合物层和所述第二聚合物层中的一种为超高分子量聚乙烯，并且所述第一聚合物层和所述第二聚合物层中的另一种为聚醚嵌段酰胺。
21.根据权利要求13所述的方法，其特征在于，所述柔性内部芯包含金属编织物。
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