CN102470030A - 包含静电纺纤维层的假体装置及其制备方法 - Google Patents

包含静电纺纤维层的假体装置及其制备方法 Download PDF

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Publication number
CN102470030A
CN102470030A CN2010800348927A CN201080034892A CN102470030A CN 102470030 A CN102470030 A CN 102470030A CN 2010800348927 A CN2010800348927 A CN 2010800348927A CN 201080034892 A CN201080034892 A CN 201080034892A CN 102470030 A CN102470030 A CN 102470030A
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Prior art keywords
dispersion
described method
static
nanofiber
eptfe
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B·L·阿诺
R·L·巴拉德
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Zeus Inc
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Zeus Inc
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Abstract

依照本发明公开内容的某些实施方案，提供了形成假体装置的方法。所述方法包括形成聚合纳米纤维、纤维化聚合物和溶剂的分散体，所述分散体具有至少约50,000cPs的粘度。将管状框架定位于管状聚合结构上。将所述分散体中的纳米纤维静电纺至管状框架上以形成假体装置。加热该假体装置。

Description

包含静电纺纤维层的假体装置及其制备方法
相关申请的交叉参考
本申请基于并要求享有提交日为2009年8月7日的美国临时申请61/232,252的优先权，该申请通过引用并入本文。
背景技术
膨胀性聚四氟乙烯(ePTFE)挤塑管作为人造可移植的人工血管或管状移植物(具体的是为人造的人工血管或管状移植物的应用而设计的)的成功应用是为人们所熟知并记载的。通过有效的临床研究所验证的ePTFE，尤为适宜作为人工血管或管状移植物，因为它显示出优良的生物相容性，并且可机械操控以形成明确定义的多孔微细构造(已知促进内皮化)。已证实在血管应用中PTFE显示出低的血栓形成反应。当埋入(seeded)或注入心脏保护剂时，由结点和原纤维形成的微孔结构在植入血管系统时能够使天然组织向内生长并且使细胞内皮化。这有助于该管状移植物的长期愈合和开放。
在现有技术(美国专利6,436,135Goldfarb)中，由ePTFE形成的人造人工血管或管状移植物的微细构造由纤维状态来进行分类，该纤维状态进一步通过不规则隔开的结点定义，所述的结点通过细长的原纤维或微纤维交互连接。用于制备这种结构的方法和技术在30多年前就已经知道了并且实际上对于本领域技术人员来说是相当简单的。原纤维所跨的结点表面之间的距离定义为结间距(IND)。具有特定范围IND的管状移植物增强了组织向内生长和细胞内皮化，因为该管状移植物本身是多孔的。所述IND范围也是小到足以防止透壁血流和血栓症，而不是小于平均红血细胞的最大尺寸(6μ至80μ)。
现有技术全部是微孔ePTFE管状人工血管或管状移植物的实例。ePTFE人工血管或管状移植物的孔隙率由IND的机械结构或管的微孔结构控制。IND和提及的限定结构产生了组织向内生长以及细胞沿着人工血管或管状移植物的内外表面内皮化的结果。
同样地，支架通常用于修复和维持身体通道，例如血管。通常，可以在支架的内或外表面提供生物相容性材料(包括移植物)，以减少支架和身体接触有关的反应。
但是，难以用这类常规装置操控机械性能、细胞增殖、细胞通透性、流体通透性、附着结构框架、和/或向其中加入活性治疗成分。而且，这类常规装置并没有考虑另外不能单独用ePTFE或其它材料包覆的复杂几何体的涂料。
因此，需要解决上文所述不足的方法。由这类方法制备的假体装置也将尤为有利。
发明概述
依照本发明公开内容的某些实施方案，提供了形成假体装置的方法。所述方法包括形成聚合纳米纤维、纤维化聚合物和溶剂的分散体，所述分散体具有至少约50,000cPs的粘度。将管状框架(例如支架)定位于管状聚合结构上。将分散体中的纳米纤维静电纺至该管状框架上以形成假体装置。加热该假体装置。
在本发明公开内容的其它实施方案中，用于形成假体装置的方法包括形成聚合纳米纤维、纤维化聚合物和溶剂的分散体，所述的分散体具有至少约50,000cPs的粘度。将分散体中的纳米纤维静电纺至管状聚合结构上。将聚合材料层包裹纳米纤维并包裹管状聚合结构以形成假体装置。加热所述的组合结构。
在本发明公开内容的其他实施方案中，公开了形成假体装置的方法。所述方法包括形成聚合纳米纤维、纤维化聚合物和溶剂的分散体，所述分散体具有至少约50,000cPs的粘度。将管状框架定位于管状聚合结构之上。将分散体中的纳米纤维静电纺至该管状框架上。将聚合材料层包裹纳米纤维并包裹管状框架和管状聚合结构以形成假体装置。加热该假体装置。
本发明公开内容的其它特征和方面更详细地讨论于下文。
附图简述
完整和可授权的公开内容(包括其针对本领域普通技术人员的最佳方式)在本说明书剩余部分中更具体地列出，本说明书剩余部分提及附图，其中：
图1-4显示依照本发明公开内容的不同假体装置的横断面图。
发明详述
现在将详细参照本发明公开内容的多种实施方案，将其一个或多个实施例列于下文。各实施例通过本发明公开内容的示例而提供，并不限制本发明的公开内容。实际上，本领域的技术人员显然可以在不脱离本发明公开内容范围或精神的前提下进行在本发明公开内容中的多种修饰和变化。例如，作为一个实施方案的部分显示或描述的特征，可以用于另一个实施方案以得到又一个实施方案。因此，本发明公开内容意欲涵盖所附权利要求和它们等同物的范围内所引起的这类修饰和变化。
本发明涉及管状假体装置(在本文中还涉及“管状人工血管”和/或“管状移植物”和/或“管状框架”)，该管状假体装置包括了在这类装置中央腔周围环绕的静电纺(在本文中还指“espin”和/或“espun”和/或“espinning”)纤维。在某些实施方案中，所述的中央腔可以包含膨胀性聚四氟乙烯(在本文中还指“ePTFE”)。在某些实施方案中，所述的静电纺(espin)纤维可以包含聚四氟乙烯(在本文中还指“静电纺PTFE”)，但是，除了这类静电纺PTFE之外或与这类静电纺PTFE组合可以静电纺以及使用的有很多其它适宜的材料。例如，依照本发明公开内容可以静电纺的其它适宜的材料包括聚酰胺、聚氨酯(PU)、聚酯、氟化乙丙烯(FEP)等。可以置于溶液中的聚合物就有可能被静电纺。可以制成分散体的聚合物颗粒(例如，PTFE、FEP等)也有可能被静电纺。所述分散体(静电纺PTFE)必须烧结以产生所需的性能，但是从溶液中静电纺出的很多聚合物在纺织和干燥期间发展了它们的性质。静电纺层的附着可能会发生在烧结期间。
在本发明公开内容的某些实施方案中，描述了可移植的微孔管状人工血管或管状移植物，其含有的主要是微米和亚微米大小的静电纺PTFE纤维，该PTFE纤维随机取向地环绕着中央腔。所述的管状人工血管或管状移植物可以包括一层或多层，所述层形成静电纺PTFE纤维环绕管状结构(例如管状人工血管、管状移植物、管状框架或其组合)的组合结构。
本发明公开内容与常规方法和装置相比具有许多优势，包括：1)并入具有极大差异孔结构和孔径的层的能力，这些不同的结构层可以用以操控机械性能、细胞增殖、细胞通透性、流体通透性、附着结构框架、和/或加入活性治疗成分；2)制备具有极大差异部件(满足更广泛的治疗用途和结构)的复合构造的能力；3)改善PTFE层对结构框架以及该构造的其它层的结合；4)加入静电纺层的能力，该静电纺层酷似提供细胞反应更强控制的细胞外基质的层；以及5)实现了不能通过其他形式单独用ePTFE或其它材料包覆的复杂几何体的涂料。
所述的管状结构可以包含如上所述的自封式热塑性或弹性组件，以及选择的生物活性剂。可以与本发明公开内容所述的装置结合使用的这类生物活性剂的实例包括但不限于：抗生素、抗真菌剂和抗病毒剂，例如红霉素、四环素、氨基糖苷类、头孢菌素类、喹诺酮类、青霉素类、磺胺类、酮康唑、咪康唑、阿昔洛韦、更昔洛韦、齐多夫定、维生素类、干扰素；例如苯妥英和丙戊酸的抗惊厥药；例如阿米替林和曲唑酮的抗抑郁药；抗帕金森综合征药；例如钙通道阻断剂、抗心律不齐药、β阻断剂的心血管药剂；例如顺铂和甲氨蝶呤的抗肿瘤药，例如地塞米松、氢化可的松、泼尼松龙和曲安西龙的皮质类固醇；例如布洛芬、水杨酸盐类吲哚美辛、吡罗昔康的非类固醇抗炎药(NSAIDs)；例如黄体酮、雌激素、睾酮的激素类；生长因子类；例如乙酰唑胺的碳酸酐酶抑制剂；前列腺素类；抗血管生成因子剂；神经保护剂；神经营养蛋白；生长因子类；细胞因子；趋化因子；例如干细胞、原代细胞和基因工程细胞的细胞；组织；以及本领域的技术人员已知的其它药剂。
参见图1，显示依照本发明公开内容的结构的横断面图。该结构包含ePTFE层1和静电纺层2。根据所需的几何形状和性能，这种结构可以加工为用于构造移植物或支架-移植物部件的组件。该结构还可以用作其它医疗装置的覆盖物，所述的医疗装置包括但不限于阻塞装置、缺损闭合装置、细胞包囊装置、再生医学支架、整容移植物、心血管补片和腹部补片为例。但是，这份清单并非包括所有，而且很多其它的应用都依照本发明公开内容被构思。
本发明公开内容的内(血液接触)层和外(组织接触)层可以具有不同的孔隙率以分别增强或抑制细胞向内生长或附着。所述可移植的静电纺人工血管的应用将会包括而不限于人造旁路移植物、冠状动脉旁路移植物、旁路分流器、血液透析、动静脉移植物、同种移植物、肺部异体移植物或肺部分流器。这种管状结构的特性可以包括增强的径向拉伸强度、缝合孔抗扯性和增强的轴向抗扯性。
参见图2，显示依照本发明公开内容的装置的横断面图。所述的装置包括ePTFE层1，框架3(例如支架框架)和静电纺层2。这种结构可以用在意欲结合ePTFE至形成的结构(例如支架、阻塞装置或其它框架)的应用中。所述的静电纺层提供附着同时也根据应用在腔或近腔表面上提供基本不同的孔径和结构。作为烧结或固化工序的一部分，在这类结构中，该静电纺层可以直接施用于所述框架的表面或作为与ePTFE和框架组合的预成形的薄板来添加。通常，这类结构可以用在意欲包裹支撑架的任何应用中。例如，这类结构可以与常规支架连接使用。
多种支架类型和支架构造都可以用于本发明公开容。在多种适用的支架之中包括，不限于，自展式支架和气囊可扩展支架(balloonexpandable extents)。所述的支架还能够径向收缩。自展式支架包括具有弹簧样作用(其导致支架径向扩展)的支架，或由于在某种温度下用于特定结构的支架材料的记忆性而扩展的支架。镍钛诺(Nitinol)是一种在弹簧样模式中以及在基于温度的记忆模式中能够表现良好的材料。本发明公开内容构思的其它材料包括但不限于，不锈钢、铂、金、钛和其它生物相容的金属以及聚合物支架。
所述支架的结构也可以选自本领域应已知的任何适宜的几何形状。例如，金属丝支架可以扎成连续螺旋图案，无论金属丝中有没有波状或之字形，以致形成径向可变形的支架。单独的环或环状构件可以连接到一起例如通过支柱、缝线、将环焊接或交织或闭合以形成管状支架。适用于本发明的管状支架还包括通过由管刻蚀或切割出图案而形成的管状支架。这种支架通常称为开槽支架(slotted stent)。此外，可以通过在材料或模子中蚀刻图案和在图案中沉积支架材料(例如通过化学气相沉积等)来形成支架。
至于图3，显示了另一个结构的横断面图。该结构包括ePTFE层1、静电纺层2，以及另一个ePTFE层1，这样使得静电纺层2夹在ePTFE层1之间。这种构造使使用者能够按所需操控复合材料的机械性，例如在压缩后改善材料复原。可以调整所述静电纺材料的选择以改善层间的结合性并且所述的静电纺层可以用于抑制在该构造上细胞穿过中间增殖。在此情况下，它可能有利于使细胞从两侧(就移植物而言为腔及近腔)迁移和增殖，而可能并不期望两者间沟通。这种中间静电纺层可以设计为具有抑制该细胞沟通的孔隙率。
至于图4，显示依照本发明公开内容的又一种结构的横断面。该装置包括ePTFE层1、静电纺层2、框架3和另一个ePTFE层1。这样，在该构造展开期间所述框架增强了整个构造的径向强度并且也促进了复原。例如，在本发明公开内容的某些实施方案中，所述框架是支架。所述支架框架在该结构内提供了结构骨干，其防止了缝合壁撕开。
所述的静电纺层优选通过本领域技术人员所理解的静电纺丝法直接施用于所述框架；但是，它也同样可以通过层压施用。该技术涉及将静电纺层压制至第二层材料层上并加热至补合温度。在所有的结构中，该设计可以包含或不包含结构框架。这些框架可采用的形式为：支架、阻塞线圈或框架、再生医学支架、结构加强物、起搏或监测导联、组织锚或平头钉、生物刺激装置、仿生移植物、信号接收器或传送器、矫形外科固定装置或任何其他金属的、聚合的、陶瓷的或其他治疗的装置。
该复合材料的性能和特性是框架层、静电纺层和ePTFE薄膜层的综合。该复合材料可以用受控纤维、结点和原纤维浆(fibril sizes)制备，并且可以在最终复合材料中在机械性方面被操控，以例如改善结合强度、延伸性和拉伸强度。
多层的典型构造可以制备出厚度为约0.0001英寸至约.25英寸总厚度，宽度约.032英寸至约80英寸。该单独的层的厚度可以为约0.0001英寸至约.25英寸。由于该复合材料可以制备为连续辊长度(roll length)的薄板或管，最终材料尺寸变化很大。所述复合材料结间距(IND)可以是约0.1至约200μm并且孔隙率为约20至90％。如ASTM F316(通过引用并入本文)所限定的孔结构可以为约0.05至约50μm。由于复合材料的构造，层与层的IND、孔径和孔隙率在所述的复合材料的横断面内可以根据所述的构造而变化。一个实例是不对称的构造，基于对贯穿中间的表面至表面间层的评估，该不对称构造中的孔径从大到小变化。
可以使用本文所描述的预制组件和/或材料，将如本文所描述的框架和移植物结构的构造中所用的材料制备成部件。该材料可以组装于单层中或双层中。可能有益的是将如图2中所示的构造制备为组件，以用于本文所述的另一个构造。对于图4中所示的实施方案，可以按所需将预制组件与最终的框架和ePTFE附加层连接而制备最终的部件。
例如，在其中静电纺层是管状结构的一部分的实施方案(如本文前述的)中，静电纺层中的纤维直径的尺寸可以为约10nm至2000nm，壁厚为约75μ至1.5mm，并且平均内径为约0.2mm至50mm。
本发明公开内容所述的装置可以用受控纤维、结点和原纤维浆(fibrilsizes)制备，并且可以操控机械性值例如结合强度、延伸性和拉伸强度。
膨胀性PTFE包含微细构造，该微细构造由细微的、高度取向的原纤维交互连接的实心结点组成。所述的膨胀性PTFE结点和原纤维提供了独特的生物相容的多孔结构。该材料的微细构造可以调整以提供用于细胞附着和向内生长的基质。所述的膨胀性PTFE和静电纺PTFE微细构造旨在增强抑制或阻止在愈合早期期间的内皮的转移。
例如，结点至原纤维距离为约10-20μm的ePTFE微细构造允许很小的透壁细胞向内生长。生长细胞的最佳孔隙率范围在20和80μm之间。研究已显示：基于较小的表面可用于细胞的附着和运动，孔隙＞120μm与生长降低和新内膜附着弱相关。
在本发明公开内容的某些实施方案中，所述的方法可以需要约10至85％重量的PTFE硬粒分散体或悬浮液，以助于将收集的纤维垫加工成具有足够初始强度(green strength)的形式。但是，如上所述，其它适宜的聚合物可以用于静电纺分散体。如果在分散体中的固体含量太低，所得材料将无机械完整性或机械完整性弱。其次，用于增加溶液、悬浮液或分散体粘度以供纺织的聚合物必须仔细地挑选。
此外，当烧结或结合静电纺层时，必需确保选择适宜烧结该材料的温度，以至于所得的产品具有良好的机械完整性。
为制备非编织静电纺PTFE材料，在水性分散体中提供了粒度分布狭窄的PTFE粉末。所述的粒度优选地是约0.05至0.8μ。将按重量计约1至10wt％的纤维化聚合物加入所述体积的PTFE水性分散体中。所述的纤维化聚合物应具有高的水中的溶解度并且大于约0.5wt％的溶解度是优选的。优选的是，当在约400℃下烧结时，纤维化聚合物的灰分含量小于约5wt％，甚至更低才是更优选的。特别优选的纤维化聚合物可以包括，但不限于右旋糖酐、海藻酸盐或酯、壳聚糖、瓜尔胶化合物、淀粉、聚乙烯基吡啶化合物、纤维质化合物、纤维素醚、水解聚丙烯酰胺、聚丙烯酸酯、聚羧酸酯、聚乙烯醇、聚环氧乙烷、聚乙二醇、聚乙烯亚胺、聚乙烯吡咯烷酮、聚乳酸、聚甲基丙烯酸、聚衣康酸、聚2-羟乙基丙烯酸酯、聚2-二甲基氨基乙基甲基丙烯酸酯-丙烯酰胺共聚物、聚n-异丙基丙烯酰胺、聚2-丙烯酰氨基-2-甲基-1-丙烷磺酸、聚(甲氧基乙烯)、聚(乙烯醇)、聚(乙烯醇)12％乙酰基、聚(2，4-二甲基-6-三嗪基乙烯)、聚(3-吗啉基乙烯)、聚(N-1，2，4-三唑基乙烯)、聚(乙烯基亚砜)、聚(乙烯胺)、聚(N-乙烯基吡咯烷酮-乙酸乙烯酯共聚物)、聚(g-谷氨酸)、聚(N-丙酰亚氨基乙烯)、聚(4-氨基-磺基-苯胺)、聚[N-(对磺基苯基)氨基-3-羟甲基-1，4-亚苯基亚氨基-1，4-亚苯基)]、异丙基纤维素、羟基乙基、羟丙基纤维素、醋酸纤维素、硝酸纤维素、海藻酸铵盐、i-角叉菜胶、N-[(3′-羟基-2′，3′-二羧基)乙基]壳聚糖、魔芋葡甘露聚糖(konjac glocomannan)、支链淀粉、黄原胶、聚(烯丙基氯化铵)、聚(烯丙基磷酸铵)、聚(二烯丙基二甲基氯化铵)、聚(苄基三甲基氯化铵)、聚(二甲基十二烷基(2-丙烯基酰氨基乙基)溴化铵)、聚(4-N-丁基吡啶鎓乙烯碘)、聚(2-N-甲基吡啶鎓亚甲基碘)、聚(N甲基吡啶鎓-2，5-二基亚乙烯基)、聚乙二醇聚合物和共聚物、纤维素乙醚、纤维素乙基羟基乙基醚、纤维素甲基羟基乙基醚、聚(1-丙三醇甲基丙烯酸酯)、聚(2-乙基-2-噁唑啉)、聚(2-羟乙基甲基丙烯酸酯/甲基丙烯酸)90∶10、聚(2-羟丙基甲基丙烯酸酯)、聚(2-甲基丙烯酰氧基乙基三甲基溴化铵)、聚(2-乙烯基-1-甲基吡啶鎓溴化物)、聚(2-乙烯基吡啶N-氧化物)、聚(2-乙烯基吡啶)、聚(3-氯-2-羟基丙基-2-甲基丙烯酰氧基乙基二甲基氯化铵)、聚(4-乙烯基吡啶N-氧化物)、聚(4-乙烯基吡啶)、聚(丙烯酰胺/2-甲基丙烯酰氧基乙基三甲基溴化铵)80∶20、聚(丙烯酰胺/丙烯酸)、聚(烯丙胺盐酸盐)、聚(丁二烯/马来酸)、聚(二烯丙基二甲基氯化铵)、聚(乙基丙烯酸酯/丙烯酸)、聚(乙二醇)双(2-氨基乙基)、聚(乙二醇)单甲醚、聚(乙二醇)-双酚A二缩水甘油醚加合物、聚(环氧乙烷-b-环氧丙烷)、聚(乙烯/丙烯酸)92∶8、聚(1-赖氨酸氢溴酸盐)、聚(1-赖氨酸氢溴酸盐)、聚(马来酸)、聚(正-丁基丙烯酸酯/2-甲基丙烯酰氧基乙基三甲基基溴化铵)、聚(N-异-丙基丙烯酰胺)、聚(N-乙烯基吡咯烷酮/2-二甲基氨基乙基甲基丙烯酸酯)硫酸二甲酯季铵盐(poly(N-vinylpyrrolidone/2-dimethylaminoethyl methacrylate)，dimethyl sulfatequaternary)、聚(N-乙烯基吡咯烷酮/乙酸乙烯酯)、聚(氧乙烯)脱水山梨醇单月桂酸酯(吐温
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)、聚(苯乙烯磺酸)、聚(乙烯醇)、N-甲基-4(4′-甲酰基苯乙烯基)吡啶、甲基硫酸酯缩醛、聚(乙烯基甲基醚)、聚(乙烯胺)盐酸盐、聚(乙烯基膦酸)、聚(乙烯基磺酸)钠盐、聚苯胺，及其组合。此外，但是，也考虑将这类纤维化聚合物与其它聚合物静电纺分散体一同使用。
特别优选的纤维化聚合物是聚环氧乙烷，具有分子量为约50,000至4,000,000amu的聚环氧乙烷。在混合之后，优选使PTFE和纤维化聚合物分散体均质化。在特别优选的方法中，使所述的聚合物溶液在不搅动的前提下慢慢地形成，接着转移至罐滚筒，从而将使它恒速转动另外几天。本发明的公开内容构思了将大于50,000cPs分散体用于提供更均匀一致纤维成型以及更快构造。优选在所得的高度粘稠混合物中制备几乎没有空气残留的均匀溶液。一旦分散体为均匀稠度，优选过滤移除任何团块或凝胶。随后将具有所需粘度的过滤分散体装入具有固定传导元件充当电荷源的受控泵送装置中。
特别优选的传导元件是具有一个或多个喷嘴的元件。所述喷嘴的尺寸优选(但不限于)直径约0.01至3.0mm。将从泵送装置喷出的体积设为预定的速度，该速度取决于制备的形式和所需的纤维直径。所述电荷源优选连接到精密DC电源的正极。所述电源的负极优选连接到收集表面或靶点。所述的极可以颠倒但这不是优选的。
所述的表面可以为圆筒、装置或薄板。所述表面可以是金属的、陶瓷的或聚合的材料，特别优选的材料选自不锈钢、钴铬、镍钛(镍钛诺)和镁合金。所述电源的电压增加至所需的电压以均匀拉出聚合物/PTFE溶液。
所述的施用电压典型地是约2,000至80,000伏。由连接电源诱发的电荷排斥荷电的聚合物远离电荷源并将它们吸引至收集表面。
所述的收集靶点优选垂直泵和喷嘴系统放置并且在至少一个方向上移动以至均匀覆盖整个表面，纤维被拉向靶点。一旦收集表面被充分地盖住，优选如下将材料固化、烧结及干燥(其可以同时或以一系列的步骤进行)：或者在适当的位置，将整个收集表面放置在烘炉中，或者将薄板管或其它形式从所述的收集表面移出并将它在烘炉中烧结。
本领域的技术人员熟知的是，静电纺织物在烧结时会皱缩。然而并不限于任何理论，所述的皱缩被认为会在两个步骤中出现。首先，纺织的纤维和织物含有如前所述的水和纤维化聚合物。一旦纺织完成，样品干燥并发生低度纤维重排。随后，通过将所述的纤维和织物暴露于温度约35℃至约485℃一段时间来加热该样品。
为了适应皱缩，纤维和织物可以纺织至膨胀性结构上。然后可以将所述的结构移去或收缩。在静电纺层烧结期间，所述的织物皱缩至较小尺寸而不破裂。另一个方法涉及在烧结之前或在烧结期间将纤维和织物纺织至随后可以扩展和/或收缩的结构上。收缩或扩展和收缩的幅度是约3至100％数量级并且取决于电沉积织物的厚度和尺寸。或者可以将所述静电纺层置于在烧结期间也会收缩的表面上。
对于一张织物，如果指定沉积方向为垂直于所述织物平面，那么收缩或扩展/收缩必定存在于织物平面中至少一个或多个方向。对于沉积在圆柱表面的织物，所述的织物必定会径向和/或纵向收缩或收缩/扩展。对于球面，所述织物必定径向收缩或收缩/扩展。收缩和/或扩展/收缩的这些基本概念可以用于任何静电纺织物，而与它纺织至的表面形状无关。因此，基于静电纺织物的很复杂织物的形状成为可能。
所述的静电纺层优选是纤维的。特别优选的静电纺纤维具有至少0.1μ的直径。在一个特别优选的实施方案中，烧结后的产品具有沉积了一定密度的纤维，所述浓度使接触点的间距为0.1至50μ。
本发明的公开内容可以参考下列实施例来更好的理解。
具体实施方式
下列一般指导原则用于本文所描述的多种ePTFE和静电纺复合构造的加工实施例。
1.在静电纺PTFE的实施方案中，可以通过加入水或从分散体中移除水而不改变PEO与PTFE之比来改变分散体的粘度。
2.将径向扩展的ePTFE管或双轴取向薄板放置在圆形或平底板上以形成所需的几何形状。
3.将静电纺聚合物层以所需的厚度(典型地约0.5至1000μm)施用在ePTFE上或应用在随后被配合至ePTFE膜的表面上，得到了组合结构。
4.如果静电纺涂料湿用于ePTFE，那么在进入下一步工序前要将它干燥。但是，如果将它加工为单个静电纺薄板并且已经干燥，那么它将被配合至取向的多孔ePTFE层。材料间的配合工序可以重复多次，直到制备出所需的多层组合结构。
5.然后将所述的ePTFE/静电纺复合材料用不粘的释放箔(releasefoil)覆盖。
6.一旦所述的复合材料抵在底部器械上，压力就会施加于箔表面，从而有助于结合工序。
7.将所述的复合构造放入温度为约35℃至约485℃的烘炉中以使所有的材料结合到一起。所述结合温度基于材料的选择而选择。
8.一旦将该部分从烘炉中移出并且以每分钟约15至25度的速度冷却，它将被显露并检测到特定的性能。
实施例1：
I型构造：ePTFE/静电纺PTFE：
将具有结间距(IND)为20μ、内径(ID)为4mm、壁厚(WT)为0.1mm和孔隙率为77.27％的双轴(Biax)扩展约10cm长的ePTFE管放置并且定位于外径(OD)为4mm的35cm长的不锈钢(SS)管的中央。将所述管组件置于转动的卡盘中，以使它处于能够沿该旋转的管组件全长进行静电纺的位置。
将基于4.2％(PEO/PTFE)、300,000amu聚环氧乙烷和Daikin D21060％PTFE分散体(已被均质化、然后旋转和过滤以得到平滑的稠度)的混合物的约85,900cPs的静电纺分散体置于配有22计量注射针的10ml塑料注射器中。将所述注射器置于Harvard Model 702100注射泵中并且设定泵出速度为2.0ml/小时。所述的针尖位于距离所述旋转的管组件约9.5cm的位置。所述管组件以约60rpm旋转。使用横移平台(traverse)沿该管的长度以3.2mm/秒的移行速度移动静电纺针。将该横移平台的返点设定在Biax管末端。采用9.2kV电压。在这些条件下将PTFE静电纺至所述管上持续30分钟以得到约25μ(如烧结后所沉积)厚的PTFE纤维覆盖物。
在使Biax管/静电纺PTFE组件过度干燥后，将静电纺PTFE移出并将该复合移植物在SS管上385℃烧结10分钟。在冷却之后，使用异丙醇便于从该管移出复合移植物。
实施例2：
I型构造：ePTFE/静电纺PTFE：
与实施例1相同，除了：在干燥和移出过量PTFE后，随后将该管组件包裹在80μ不锈钢(SS)箔中，接着再用未烧结的25μ厚的ePTFE膜包裹，该ePTFE膜施用在整个组件的周围。然后将所述的管组件置于烘炉中385℃下预热15.0分钟。从烘炉中移出并冷却后，该SS箔和25μ厚的膜被移除以显示出复合移植物。使用异丙醇便于从该管移除出植物。
实施例3：
II型构造：ePTFE/支架/静电纺PTFE：
将具有结间距(IND)为20μ、内径(ID)为4mm、壁厚(WT)为0.1mm和孔隙率为77.27％的双轴(Biax)扩展约6cm长的ePTFE管置于外径(OD)为4mm的35cm长的不锈钢管的末端。然后将长5.2cm、ID为4.25mm并且WT为0.125mm的普通支架轻微地展开、放置并定位在ePTFE管中央。然后将所述ePTFE管组件置于SS管的中点并置于转动的卡盘中，以使它处于能够沿该旋转的管组件全长进行静电纺的位置。
将基于4.2％(PEO/PTFE)、300,000amu聚环氧乙烷和Daikin D21060％PTFE分散体(已被均质化、然后旋转和过滤以得到平滑的稠度)的混合物的约85,900cPs的静电纺分散体置于配有22计量注射针的10ml塑料注射器中。将所述注射器置于Harvard Model 702100注射泵中并且设定泵出速度为2.0ml/小时。所述的针尖位于距离所述旋转支架/管组件约9.5cm。所述支架/管组件以约60rpm旋转。使用横移平台沿SS管的长度以3.2mm/秒的移行速度移动静电纺针。将该横移平台的返点设定在Biax管末端。采用9.2kV电压。在这些条件下将PTFE静电纺至所述管上持续60分钟以得到约50μ(如烧结后所沉积)厚的PTFE纤维覆盖物。
在使该管组件干燥后，将该复合支架-移植物在SS管上385℃烧结15分钟。在冷却之后，使用异丙醇以便于从该管移出所述的支架-移植物。
实施例4：
II型构造：ePTFE/支架/静电纺PTFE：
与实施例3相同，除了：在使所述的支架-管组件干燥后，随后将它包裹在80μ不锈钢(SS)箔中，接着再用未烧结的25μ厚的ePTFE膜包裹，该ePTFE膜施用在整个组件的周围。然后将所述的支架-管组件置于烘炉中385℃下预热15.0分钟。冷却后，该SS箔和25μ厚的膜被移除以显示出所述的支架-移植物。使用异丙醇便于从该管移除出植物。
实施例5：
III型构造：ePTFE/静电纺PTFE/ePTFE：
将具有结间距(IND)为20μ、内径(ID)为4mm、壁厚(WT)为0.1mm和孔隙率为77.27％的双轴(Biax)扩展约10cm长的ePTFE管放置并且定位于外径(OD)为4mm的35cm长的不锈钢的中央。将所述管组件置于转动的卡盘中，以使它处于能够沿该旋转的管组件全长进行静电纺的位置。
将基于4.2％(PEO/PTFE)、300,000amu聚环氧乙烷和Daikin D21060％PTFE分散体(已被均质化、然后旋转和过滤以得到平滑的稠度)的混合物的约85,900cPs的静电纺分散体置于配有22计量注射针的10ml塑料注射器中。将所述注射器置于Harvard Model 702100注射泵中并且设定泵出速度为2.0ml/小时。所述的针尖位于距离所述旋转的管组件约9.5cm的位置。所述管组件以约60rpm旋转。使用横移平台沿所述管的长度以3.2mm/秒的移行速度移动静电纺针。将该横移平台的返点设定在Biax管末端。采用9.2kV电压。在这些条件下将PTFE静电纺至所述管上持续60分钟以得到约50μ(如烧结后所沉积的)厚的PTFE纤维覆盖物。
在使管组件在50℃下干燥1小时后，用基重9.955gsm和厚度为28μ的ePTFE膜将所述管组件裹4次。然后将该管组件用未烧结的25μ厚的ePTFE膜包裹，该ePTFE膜紧紧施用在整个组件的周围。然后将所述的管组件置于烘炉中385℃下预热15.0分钟。冷却后，将该25μ厚的膜移除以显示出所述的移植物。使用异丙醇便于从该管移除该移植物。
实施例6：
III型构造：ePTFE/静电纺PTFE/ePTFE：
与实施例5相同，除了：在使管组件干燥后，用基重(basis weight)9.955gsm和厚度为28μ的ePTFE膜将所述管组件裹4次。然后将该管组件包裹在80μ不锈钢(SS)箔中，接着再用未烧结的25μ厚的ePTFE膜包裹，该ePTFE膜施用在整个组件的周围。然后将所述的管组件置于烘炉中385℃下预热15.0分钟。冷却后，该SS箔和25μ厚的膜被移除以显示出所述的移植物。使用异丙醇便于从该管移除该移植物。
实施例7：
IV型构造：ePTFE/支架/静电纺PTFE/ePTFE：
将具有结间距(IND)为20μ、内径(ID)为4mm、壁厚(WT)为0.1mm和孔隙率为77.27％的双轴(Biax)扩展约6cm长的ePTFE管置于外径(OD)为4mm的35cm长的不锈钢的末端。然后将长为5.2cm、ID为4.25mm并且WT为0.125mm的普通支架(generic stent)轻微地展开、放置并定位在ePTFE管中央。然后将所述ePTFE管组件置于SS管的中点并置于转动的卡盘中，以使它处于能够沿旋转的管组件全长进行静电纺的位置。
将基于4.2％(PEO/PTFE)、300,000amu聚环氧乙烷和Daikin D21060％PTFE分散体(已被均质化、然后旋转和过滤以得到平滑的稠度)的混合物的约85,900cPs的静电纺分散体置于配有22计量注射针的10ml塑料注射器中。将所述注射器置于Harvard Model 702100注射泵中并且设定泵出速度为2.0ml/小时。所述的针尖位于距离所述旋转的支架/管组件约9.5cm的位置。所述支架/管组件以约60rpm旋转。使用横移平台沿杆的长度以3.2mm/秒的移行速度移动静电纺针。将该横移平台的返点设定在该支架的末端。采用9.2kV电压。在这些条件下将PTFE静电纺至所述管上持续60分钟以得到约50μ(如烧结后所沉积)厚的PTFE纤维覆盖物。
在使管组件干燥后，用基重9.955gsm和厚度为28μ的ePTFE膜将所述支架/管组件裹4次。然后将该支架/管组件用未烧结的25μ厚的ePTFE膜包裹，该ePTFE膜紧紧施用在整个组件的周围。然后将所述的管组件置于烘炉中385℃下预热15.0分钟。冷却后，将该25μ厚的膜移除以显示出支架-移植物。使用异丙醇便于从该管移除该支架-移植物。
实施例8：
IV型构造：ePTFE/支架/静电纺PTFE/ePTFE：
与实施例7相同，除了：在使管组件干燥后，用基重9.955gsm和厚度为28μ的ePTFE膜将所述支架-管组件裹4次。然后将该支架-管组件包裹在80μ不锈钢(SS)箔中，接着再用未烧结的25μ厚的ePTFE膜包裹5次，该ePTFE膜施用在整个组件的周围。然后将所述的管组件置于烘炉中385℃下预热15.0分钟。冷却后，该SS箔和25μ厚的膜将被移除以显示出所述的支架-移植物。使用异丙醇便于使该移植物从该管移除。
为了简短而简洁，在本说明书中所列出值的任何范围将被解释为权利要求的书面描述支持，权利要求叙述了具有端点的任何子范围，该端点是在所讨论的指定范围内的所有数值。通过假设的示例性实施例，本说明书中公开内容的1-5的范围被认为支持保护下列子范围中的任何一个：1-4；1-3；1-2；2-5；2-4；2-3；3-5；3-4；和4-5。
本领域普通技术人员在不偏离本发明公开内容的精神和范围(在所附权利要求中更具体地列出)的前提下，可以实践本发明公开内容的这些和其它修饰和变体。此外，应当理解所述的多种实施方案的各方面可以在整体上或部分上进行互换。此外，本领域那些普通技术人员将理解之前的描述仅仅是为了举例说明，并无意限制本发明的公开内容。

Claims (20)

1.形成假体装置的方法，其包括：
形成聚合纳米纤维、纤维化聚合物和溶剂的分散体，所述的分散体具有至少约50,000cPs的粘度；
将管状框架定位于管状聚合结构上；
将纳米纤维从所述分散体静电纺至所述的管状框架上以形成假体装置；并且
加热所述的假体装置。
2.权利要求1所述的方法，其中所述的纳米纤维包含PTFE。
3.权利要求2所述的方法，其中所述的分散体含有约50-80重量百分比的PTFE。
4.权利要求1所述的方法，其还包括烧结。
5.权利要求1所述的方法，其中所述的溶剂包括水。
6.权利要求1所述的方法，其中所述的纤维化聚合物包括聚环氧乙烷。
7.权利要求1所述的方法，其中所述的管状聚合结构含有ePTFE。
8.用于形成假体装置的方法，其包括：
形成聚合纳米纤维、纤维化聚合物和溶剂的分散体，所述的分散体具有至少约50,000cPs的粘度；
将纳米纤维从所述分散体静电纺至管状聚合结构上；使聚合材料层包裹所述的纳米纤维并且包裹所述的管状聚合结构以形成假体装置；并且
加热所述的组合结构。
9.权利要求8所述的方法，其中所述的纳米纤维包含PTFE。
10.权利要求9所述的方法，其中所述的分散体含有约50-80重量百分比的PTFE。
11.权利要求8所述的方法，其还包括烧结。
12.权利要求8所述的方法，其中所述的溶剂包括水。
13.权利要求8所述的方法，其中所述的纤维化聚合物包括聚环氧乙烷。
14.权利要求8所述的方法，其中所述的管状聚合结构含有ePTFE。
15.权利要求8所述的方法，其中所述的聚合材料层含有ePTFE。
16.形成假体装置的方法，其包括：
形成聚合纳米纤维、纤维化聚合物和溶剂的分散体，所述的分散体具有至少约50,000cPs的粘度；
将管状框架定位于管状聚合结构上；
将纳米纤维从所述分散体静电纺至所述的管状框架上；
将聚合材料层包裹所述的纳米纤维并且包裹所述的管状框架和管状聚合结构以形成假体装置；并且
加热所述的假体装置。
17.权利要求16所述的方法，其中所述的纳米纤维包含PTFE。
18.权利要求16所述的方法，其中所述的管状聚合结构含有ePTFE。
19.权利要求16所述的方法，其中所述的聚合材料层含有ePTFE。
20.权利要求16所述的方法，其中所述的纤维化聚合物括聚丙烯酰胺、聚乙烯醇、聚乙烯吡咯烷酮、右旋糖酐、海藻酸盐或酯、壳聚糖、瓜尔胶化合物、淀粉、纤维质化合物、聚丙烯酸酯、聚羧酸酯、聚乳酸、聚甲基丙烯酸，或其组合。
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