CN109310507B - 编织型支撑结构 - Google Patents

编织型支撑结构 Download PDF

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CN109310507B
CN109310507B CN201780034804.5A CN201780034804A CN109310507B CN 109310507 B CN109310507 B CN 109310507B CN 201780034804 A CN201780034804 A CN 201780034804A CN 109310507 B CN109310507 B CN 109310507B
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CN109310507A (zh
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卢卡斯·哈德
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Edwards Lifesciences Corp
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HLT Inc
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Abstract

一种编织型支撑结构，其在从递送装置释放时折叠，其中所述折叠至少部分地通过在期望折叠的位置处改变编织物的图像角来实现。

Description

编织型支撑结构
背景技术
心血管植入物优选经皮递送，以减少患者创伤、减少患者承受的创伤且显著缩短恢复期。通过使用通过例如股动脉引入的一个或多个导管，可以将工具和装置递送到心血管系统中的期望区域以执行许多通常需要侵入性外科手术的复杂手术。作为进行心内直视手术的替代方案，经皮方法特别有吸引力。
瓣膜置换手术提供了在开发经皮解决方案的领域中的一个示例。许多疾病导致心脏瓣膜小叶增厚，且伴随着不移动或移动性降低。这种不移动也可能导致通过瓣膜的通道变窄或狭窄。狭窄瓣膜所呈现的血流阻力增加最终可导致心力衰竭并终将导致死亡。
在主动脉瓣膜置换的情况下，将导管插入股动脉并在有或没有导丝的情况下导行通过动脉、围绕主动脉弓并且在主动脉瓣的位置处导入心脏。随着导管尺寸的减小，导管导行的容易程度大大增加。然而，为了减小导管尺寸，需要具有小输送轮廓的植入物。这些植入物必须能够扩展到原生解剖学特征(例如主动脉瓣)的大小以便有效作用。
已经开发的一种解决方案是附接到编织型支撑结构的假体瓣膜。该装置在几个专利和公开申请中示出和描述，包括于2015年3月10日授权的Thill等人的美国专利号8,974,523，在此引入作为参考。编织型支撑结构是管状网，其能够通过非常小直径的输送导管输送。管状网由一根或多根细股线编织或编织在一起成为细长管而形成。股线可以是纤维状、非纤维状、复丝或单丝。股线表现出形状记忆，使得细长管可以形成所需的折叠形状，然后伸展成非常小直径的细长构型。小直径细长构造使得直径非常小的输送导管成为可能。
在展开后，将细长管缓慢地推出输送导管，在那里它逐渐恢复其折叠的构造构型。该管符合目标血管的内部几何形状。此外，编织物有效地捕获可能从血管壁释放的所有栓子。
随着管继续从输送导管推动，当它重新获得其构造的构型时，它开始在其自身上折叠。当它折叠在自身上时，每层施加的力加在一起，使结构逐渐变强。因此，可以在不改变装置的细长直径的情况下实现不同水平的强度。
使用该折叠管，可以连接瓣膜，使得在输送导管内处于其细长构型的瓣膜或其他结构(例如过滤器)不驻留于细长管内，但是在展开时可以定位在管子中、在管子的上方或下方。
为了使该装置在退出导管时折叠，在制造期间将预成型的折叠热定形到编织管中。然后在装载过程中展开这些折叠。当在导管中时，由于导管对装置的限制，预成型的折叠不能再折叠。
装置在离开导管时倾向于呈现折叠构型的程度是装置递送容易性的一个因素。如果装置在递送时没有完全折叠，则可以执行在推动装置的近端的同时拉动装置的远端的附加步骤，以便实现折叠。但是，如果不需要这个附加的步骤，那将是理想的。
此外，完成对装置的热定形以产生折叠的退火构造。然而，已经确定线的图像角决定了折叠趋势的强度。考虑到这一点，期望开发一种方法来改善装置可以展开的容易性，同时保持在递送时折叠倾向的强度。
发明内容
本文描述的发明涉及提供编织型管状支撑结构，其具有不同径向和轴向顺应性的区域或领域。通过改变导线彼此相交的角度(这里也称为图像角(pic angle))来创建这些领域。按照惯例，这里提到的图像角将相对于管状装置的纵轴测量。
更具体地，已经发现，增加图像角，使得编织物的线更倾向在圆周方向而不是纵向方向上被引导，增加了径向刚性和轴向顺应性，导致更容易折叠。相反，减小图像角，使得编织物的线更倾向在纵向方向上被引导，增加了径向顺应性和轴向刚性。
径向顺应性导致更大的折叠难度，但允许容易地压缩到导管中。因此，通过局部改变丝编织物或织编物的编织角，可以在管的给定长度内改变管状结构的刚性。因此，在圆柱形编织图案中，径向刚性和轴向刚性之间的反比关系可以在特定区域中被利用，以促进植入物与其周围环境的运动或相互作用。另外，通过将增加和减小图像角的区域组合，可以创建管状编织装置，其结合了易于展开、折叠强度以及用于装载到输送导管中的可压缩性。
附图说明
参考附图，本发明的实施例的这些和其他方面、特征和优点将能够从本发明的实施例的以下描述中变得显而易见并得以阐明，其中：
图1A是具有大于45度的图像角的编织物；
图1B是具有小于45度的图像角的编织物；
图1C是图像角为45度的编织物；
图2是本发明折叠构型的实施例；
图3是离开输送装置的本发明的实施例；
图4是本发明编织物的两根长丝的交叉点的实施例的特写图；以及
图5是具有不同图像角区域的编织装置的平面图。
具体实施方式
现在将参考附图描述本发明的特定实施例。然而，本发明可以以许多不同的形式实施，并且不应该被解释为限于这里阐述的实施例；相反，提供这些实施例是为了使本公开彻底和完整，并且向本领域技术人员充分传达本发明的范围。在附图中示出的实施例的详细描述中使用的术语不旨在限制本发明。在附图中，相同的数字表示相同的元件。
图1A、图1B和图1C包括示出具有三种一般类别的图像角的编织物的图表，并且出于常规的目的示出。相对于编织装置的纵向轴线测量图像角，其在图1A、图1B和图1C中示为水平轴线。图1A中的图像角(“图像角A”)大于45度。具有图像角A的编织物表现出径向刚性和轴向顺应性。
图1B中所示的编织物具有小于45度的图像角。具有图像角B的编织物表现出径向顺应性和轴向刚性。由于线的周向间隔密度增加，轴向刚性导致抗折叠性。另外，随着图像角减小，折叠涉及弯曲线而不是在编织物中将线在彼此上揉搓。这可以容易地设想为，如果拍摄一组纵向对齐的线，则因此具有0°的图像角。为了折叠该管，每根线必须弯曲180度。相反，由几乎周向定向的线或具有接近90度的图像角的线形成的管将容易折叠，因为线必须非常小地弯曲。
图1C的编织物具有45度的图像角。它被提供作为轴向中性和径向中性的编织物的实例。
图2示出了处于折叠状态的本发明的装置1的实施例。装置1具有两个折叠，折叠10和折叠11。折叠由展开区域(例如区域12)分开。
在装入输送导管期间，装置1塌缩成未折叠的细长圆柱体。拉伸装置1拉伸编织物使得线相对于彼此移动并且图像角都倾向于更小的状态。这种图像角的变化在本文中称为“压缩变形”。在加载期间的压缩变形将导致图像角A趋向于中性图像角C，并且使图像角C趋向于图像角B。
例如，如果处于松弛状态，管状结构1具有45度的图像角C，则随着管状结构被压缩，图像角将减小到小于45度并且因此将属于图像角B的范畴。相反，如果管状结构扩展，则图像角将增加到大于45度，因此将落入图像角A的范畴。
如果没有发生这种压缩，则编织物内的结构线将经历大量弯曲以适应折叠过程，这将需要更多的力。因此，为了促进折叠过程，邻近折叠10和11的区域，例如图3中的区域13，优选具有图像角A。
在一旦展开时遇到轴向载荷的位置，例如通过血流放置在装置上的那些，或者在需要最小变形的区域中，使用小的图像角B来促进轴向刚性。例如，参考图2，位置12将受益于图像角B，使得来自血流的相互作用和压力不会引起层内的压缩运动。类似地，图3中的位置14将受益于图像角B，以便在植入物的折叠过程中促进脊状轴向参考。
出于折叠的目的，例如在图2的位置10和11处，已经发现约60度或更大的图像角将影响折叠。回想一下，如上所述，增加管状结构的半径将增加图像角。因此，当管状结构膨胀时，首先实现约60度的图像角的管状结构的区域将开始自身反转或折叠。
图像角的变化不仅仅是管状结构的选择性膨胀和压缩的结果。这些变化被具体编织在编织物中。通过在用于形成编织物的编织心轴上提供诸如销的特征，可以在编织过程期间应用尖锐的编织角度变化的工艺，编织的线可以围绕编织心轴弯曲以改变图像角。或者，可以通过在编织已经热定形之后手动移动编织物内的各个线来实现图像角的变化。
例如，热定形编织物导致线彼此相对变形，这形成在线中形成的峰和谷。换句话说，如果线材编织在一起并且之后被解开，则线材将保持相对笔直。然而，在热定形过程中，每根线相对于交叉线变形，以形成对应于交叉点的峰和谷。
参见图4，已经发现这些峰22和谷24可用于改变图像角。通过手动地将峰22a从相应的谷24a移动到相邻的谷24b，如箭头26所示，峰和谷之间的干涉将防止移位的峰22a返回到初始的谷24a。这导致图像角的变化。
图5示出了具有区域30，32和34的装置1，这些区域具有不同的图像角。这些区域可以通过在原始编织过程中在编织心轴中提供特征，或者通过使用上面讨论的峰谷位移方法来形成。
尽管已经根据特定实施例和应用描述了本发明，但是本领域普通技术人员根据该教导可以产生另外的实施例和修改例而不脱离本发明所要求保护的精神或超出所要求保护的范围。因此，应理解，本文中的附图和描述是作为示例提供的，以便于理解本发明，而不应解释为限制其范围。

Claims (6)

1.一种编织型管状医用植入物，包括：
具有第一构型和第二构型的编织型管状结构，其中第一构型是细长的未折叠构型，第二构型是展开的折叠构型；
其中所述编织型管状结构包括：
至少一个圆周预成型折叠区域，其具有以相对于纵向轴线测量的第一编织角相交的线；
预成型圆周折叠位于所述圆周预成型折叠区域内；
所述圆周预成型折叠区域附近的至少一个主体区域，在该主体区域中线以相对于所述纵向轴线测量的第二编织角相交；
其中所述第一编织角不等于所述第二编织角；以及，
其中第一编织角不等于第二编织角至少部分地实现折叠所述编织型管状结构以形成所述第二构型。
2.如权利要求1所述的编织型管状医用植入物，其中，所述第二编织角大于所述第一编织角。
3.如权利要求1所述的编织型管状医用植入物，其中，所述第二编织角大于45度，所述第一编织角小于45度。
4.一种编织型管状支撑结构，包括：
第一端；
第二端；
第一部分，其具有以相对于纵向轴线测量的第一编织角相交的线；
第二部分，在第二部分中具有以相对于所述纵向轴线测量的第二编织角相交的线，所述第二编织角与所述第一编织角不同；
其中，选择所述第一部分和所述第二部分的位置以及第二编织角和第一编织角的不同，以在从输送导管释放时沿折叠线实现所述编织型管状支撑结构的折叠。
5.如权利要求4所述的编织型管状支撑结构，其中，所述第二编织角大于所述第一编织角。
6.如权利要求4所述的编织型管状支撑结构，其中，所述第二编织角大于45度，所述第一编织角小于45度。
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