CN105793015A - 渐缩的可植入装置以及制造这种装置的方法 - Google Patents

渐缩的可植入装置以及制造这种装置的方法 Download PDF

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CN105793015A
CN105793015A CN201480065614.6A CN201480065614A CN105793015A CN 105793015 A CN105793015 A CN 105793015A CN 201480065614 A CN201480065614 A CN 201480065614A CN 105793015 A CN105793015 A CN 105793015A
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CN105793015B (zh
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E·H·库利
J·B·邓肯
M·A·施劳德
A·R·斯图德雷四世
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WL Gore and Associates Inc
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    • B29C57/00—Shaping of tube ends, e.g. flanging, belling or closing; Apparatus therefor, e.g. collapsible mandrels
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    • A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/02—Prostheses implantable into the body
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    • A—HUMAN NECESSITIES
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    • A61F2240/00—Manufacturing or designing of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2240/00—Manufacturing or designing of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof
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    • A61F2250/00—Special features of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof
    • A61F2250/0014—Special features of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof having different values of a given property or geometrical feature, e.g. mechanical property or material property, at different locations within the same prosthesis
    • A61F2250/0039—Special features of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof having different values of a given property or geometrical feature, e.g. mechanical property or material property, at different locations within the same prosthesis differing in diameter
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    • B29K2027/00—Use of polyvinylhalogenides or derivatives thereof as moulding material
    • B29K2027/12—Use of polyvinylhalogenides or derivatives thereof as moulding material containing fluorine
    • B29K2027/18—PTFE, i.e. polytetrafluorethene, e.g. ePTFE, i.e. expanded polytetrafluorethene
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Abstract

渐缩可植入装置包括具有渐缩长度部的ePTFE管状构件。渐缩长度部提供快速回复特性。渐缩长度部可以包括多个弯曲原纤维的微观结构为特征。

Description

渐缩的可植入装置以及制造这种装置的方法
技术领域
本文档涉及渐缩的可植入装置以及制造这种装置的方法，这种装置可用于为病人体内的体腔、器官和脉管内的流体流提供内腔。
背景技术
医疗装置频繁地用于治疗病人的解剖结构。这种装置可永久或半永久地植入解剖结构以向病人提供治疗。通常，包括支架、移植物、支架移植物、过滤器、瓣膜、封堵器、标记物、标测装置、治疗剂输送装置、假体、泵、绷带和其它腔内的可植入装置的这些装置在插入位点处插入体内并输送到治疗部位。
诸如支架和支架移植物这样的装置用于人体体内的各种位置，以修复、支承和/或代替解剖的内腔，诸如血管、呼吸管道、胃肠管道等。这样的装置可例如提供用于流体流的内腔。在这种配置中，需要柔性且耐用的装置。
在各种应用中，例如具体的脉管应用中，所期望的是利用具有渐缩长度部的移植物或人造内腔。渐缩长度部和/或移植物也可用于连接分离的移植物或不同直径的管件。这样，对提供诸如移植物或支架移植物的渐缩可植入装置有持续的需要，该可植入装置具有改善的柔性和/或快速回复特性。这样的装置可改善病人的血流特性并减少血栓。
发明内容
在第一总体方面，用于修复或代替病人体内的内腔的渐缩可植入装置包括具有渐缩部的诸如ePTFE管状构件之类的管状构件。
渐缩部包括多个基本弯曲原纤维，从而提供具有快速回复特性的区域。
在各种实施例中，根据本发明的渐缩可植入装置通过如下方式来形成：在第一心轴上伸展较小直径的聚合物管状构件，第一心轴具有较大和较小的相对端部以及中间的渐缩长度段，以在聚合物管状心轴上产生第一渐缩长度部。管状构件接着在第二心轴上被纵向压缩，以通过将第一渐缩长度部变为具有多个弯曲原纤维的第二渐缩长度部从而形成渐缩可植入装置。渐缩的可植入装置接着从第二心轴移除并被准备植入病人的解剖结构内。
一个或更多的实施例的细节由下文的附图和说明书阐述。从说明书、附图和权利要求中，其它特征、目标和优势将变得明显。
附图说明
图1是根据本发明的渐缩的可植入装置的一部分的侧视图；
图2是根据本发明的ePTFE材料的微观结构的示意图；
图3A是第一渐缩心轴的侧视图，图3B是在形成阶段的渐缩的可植入装置的侧视图；以及
图4A是第二渐缩心轴的侧视图，图4B是在另一形成阶段的渐缩的可植入装置的侧视图，图4C是第二渐缩心轴和互补的阴模的侧视图。
各附图中的相同附图标记标示相同的元件。还应注意此处参考的附图并非都按比例绘制，而是可扩大来说明本发明的各方面，且在这方面，附图不应被解释为限制性的。
具体实施方式
本文档描述了用于修复、支承和/或代替解剖的内腔的装置、系统和方法。此处描述了多个可植入的医疗装置，总的来说，任何针对具体装置所描述的特征也可用于此处描述的任何其它装置。在某些示例中，针对具体装置的一个或更多特征可加入到或包括有另一装置。此外，此处所描述的特征的各种组合或子组合可大体用于此处描述的任何装置。
总的来说，此处描述的任何可植入装置可利用各种最小侵入外科技术输送至病人身体中的体内展开部位并在该处展开。同样地，这些装置也可通过脉管手术技术以手术植入。
此外，此处描述的任何可植入医疗装置可利用各种最小侵入导管部署技术输送至病人身体的体内展开部位并在该处展开。
此处描述的任何可植入医疗装置可用于修复、代替和/或支承体内腔。在各种实施例中，本发明的可植入医疗装置可用于体腔，体腔包括那些循环系统内和胃肠系统内的内腔。
如此处所用的，“可植入”意味着植入病人体内超过29天。
如此处所用的，“渐缩”或“渐缩的”总的指从装置的一部分至该装置的另一部分的过渡区域。最通常地，渐缩部将管状装置中具有内径较大的圆形横截面的一部分过渡至该装置中具有内径较小的圆形横截面的另一部分。该区域可为对称或非对称的锥形，或可为包括突起、颠倒部或扩口的形状。
为了一致性和清楚性，术语“部”用于标示例如管状构件的一段(长度)。术语“段”用于标示例如第一心轴或第二心轴的一段(长度)。这些术语不意在限制，主要是为了辅助理解各种管状构件和心轴的附图标记而选定的。
图1示出了渐缩的可植入装置100的示例，渐缩的可植入装置100包括聚合物管状构件102，聚合物管状构件102具有第一较小直径长度部104、第二较大直径长度部106以及渐缩长度部108。聚合物管状构件102可例如包括轴向可压缩的聚合材料，诸如纵向挤出并膨胀的聚合物，包括膨胀型聚四氟乙烯(“ePTFE”)、膨胀型改性PTEE、膨胀型PTEE共聚物、尼龙、聚碳酸酯、聚乙烯、聚丙烯、聚氨酯和类似物。在各种实施例中，聚合物管状构件102包括挤出的ePTFE管道，诸如在美国专利3,953,566和4,187,390号中描述的管道。在其它实施例中，聚合物管状构件102包括缠绕的ePTFE膜管。例如，构件102可包括由ePTFE膜制成的管件，ePTFE膜卷烟形缠绕在心轴的表面上，或替代地螺旋形缠绕在心轴的表面上。这种类型的ePTFE膜大体可由如美国专利第3,953,566和4,187,390号所教导的那样被制成。在其它实施例中，构件102可包括聚合物开孔材料。然而，任何适合的聚合物管状构件都在本发明的范围内。
在各种实施例中，聚合物管状构件102包括ePTFE管件，该ePTFE管件具有由原纤维互连的节点的微观结构。聚合物管状构件102的微观结构可包括多个具有平均原纤维长度的原纤维。例如，通过检查聚合物管状构件102表面的显微镜照片，并通过取在原纤维的主要方向上由原纤维连接的节点之间所进行的十次测量值的平均，确定平均原纤维长度。首先，显微镜照片由样品表面的代表性区域制成，并做了足够的放大以显示在显微镜照片的长度内的至少五个顺序的原纤维。在显微镜照片的表面沿原纤维的主要方向上所画的直线上取一系列五个测量值后，沿与第一线平行地画的第二线得到第二系列五个测量值。测量值构成相邻节点之间的距离，这些相邻节点由至少一个原纤维连接。通过该方法得到的十个测量值取平均后得到区域的平均原纤维长度。
例如，如图2所示，长度部102、108和106中任何或所有的长度部可具有多个弯曲的原纤维214。
渐缩的长度部108可例如具有快速回复特性，即类弹簧特性。如美国专利第5,026,513号大体描述的，此处的快速回复定义为，材料的伸长长度与回复长度之差相对于回复长度。伸长长度为材料在拉伸负荷下的长度，且回复长度为材料的长度。在各种实施例中，快速回复可有下列等式量化：
R R % = ( l t - l r ) ( l r ) × 100 %
其中，lt为渐缩长度部108在1％最大拉伸力下轴向伸长时的长度，且lr为在拉伸力释放五秒后的渐缩部的长度。渐缩长度部108具有快速回复特性，可例如展现出改善的弯曲特性和改善的抵抗弯曲时的弯折、收缩和/或塌缩的性能。
在各种实施例中，渐缩长度部108可包括均匀截头锥形段。在这样的实施例中，渐缩长度部108以均匀截头锥形段的方式从第一较小直径长度部104扩张至第二较大直径长度部106。
在各种实施例中，渐缩长度部108包括不均匀形状。例如，渐缩长度部108可以诸如弯曲的、非直线的形状之类的不均匀的方式从第一较小直径长度部104扩张至第二较大直径长度部106。渐缩长度部108的任何形状都在本发明的范围内。
制造本发明的渐缩可植入装置的方法描述如下。将聚合物管状构件装在具有第一较长的渐缩长度段的第一心轴上，以形成沿聚合物管状构件的一部分长度的第一渐缩长度部。聚合物管状构件从第一心轴移除，且装到并轴向压至具有第二较短的渐缩长度段的第二心轴上，以将第一渐缩长度部形成为第二渐缩长度部。阴模可选地可被用于辅助将聚合物管状构件、特别是在第二渐缩长度部上、压缩到第二心轴上。聚合物管状构件接着可从第二心轴移除。
图3A和3B示出了方法中用于形成渐缩可植入植入件的示例性步骤。聚合物管状构件102装于第一心轴330上。如图3A所示，第一心轴330包括较小直径长度段334、较大直径长度段336以及第一较长渐缩长度段338。第一较长渐缩长度段338通常位于较小直径长度段334与较大直径长度段336之间。
在各种实施例中，聚合物管状构件102初始地包括与较小直径长度段334的直径相等或稍小的直径(沿聚合物管状构件102的长度为一致)。聚合物管状构件102围绕第一心轴330的外表面放置，并沿第一较大直径长度段336的方向被拉至心轴上。在各种实施例中，当将聚合物管状构件102装于第一心轴330上时，聚合物管状构件102在第一较长渐缩长度段338上被拉伸至较大直径长度段336，从而形成第二较大直径长度部106以及具有第一较长长度的渐缩部318。
在各种实施例中，较大直径长度部104和较小直径长度部106的各自的长度可选成将具有第一较长长度的渐缩部318定位于聚合物管状构件102上期望的位置。例如，可期望具有特定长度的较大直径和特定长度的较小直径的渐缩的可植入装置。还应理解渐缩的可植入装置可在装置的相对的端部之间连续渐缩。通过提供将具有多个弯曲原纤维的渐缩部放置在较小直径长度部104与较大直径长度部106之间的方法，可形成具有至少足够长度的较小直径长度部104和较大直径长度部106的渐缩的可植入装置100。在这样的实施例中，渐缩可植入装置100可通过下述定尺寸，例如，切下聚合物管状构件102的一端或两端从而提供至少足够长度的较小直径长度部104和较大直径长度部106。
在从第一心轴330移除聚合物管状构件102之前，构件102可暴露于进一步的加工步骤。例如，聚合物管状构件102可由诸如ePTFE膜之类的生物相容加强膜缠绕。然而，任何能够用于聚合物管状构件102的生物相容材料都在本发明的范围内。
例如，聚合物管状构件102的长度部、诸如具有第一较长长度的渐缩长度部318可被加热。进一步，热量可施加于整个第一心轴330和聚合物管状构件102。对包括具有第一较长长度的渐缩长度部318的聚合物管状构件102的任何处理都在本发明的范围内。
在各种实施例中，多孔管状构件102的外表面可涂覆有弹性体。例如，如在美国专利8,029,563号中引用的，可将诸如诺稀尔技术公司(卡平特里亚，加利福尼亚州)(NuSilSiliconeTechnology(Carpenteria,Calif.))的MED-1137硅酮粘合剂A型之类的硅酮组合物施加至多孔管状构件102的外表面。在各种实施例中，在多孔管状构件102被加热后，施加弹性件。任何将弹性件施加至多孔管状构件102的做法都在本发明的范围内。
此外，在从第一心轴330移除之前，多孔管状构件102可被可选的第二多孔管状构件包围。在各种实施例中，可选的第二多孔管状构件包括比多孔管状构件102的外径更大的内径。可选的第二多孔管状构件可同心地围绕心轴330上的第一管状构件102定位。
如图4A所示，第二心轴440可包括较大直径长度段446、较小直径长度段444以及第二较短渐缩长度段448。第二较短渐缩长度段448通常位于较小直径长度段444与较大直径长度段446之间。
参考图4B，聚合物管状构件102具有第一较长长度的渐缩部318，聚合物管状构件102可装于第二管状心轴上，使得渐缩长度部318位于或靠近第二较短渐缩长度段448。聚合物管状构件102接着可沿第二心轴440向较大直径长度段446的方向纵向压缩，这使得具有第一较长长度的渐缩部318变为具有第二较短长度的渐缩部108。在这样的实施例中，聚合物管状构件102的较小直径长度部104和较大直径长度部106不经历显著的长度变化，因为仅具有第一较长长度的渐缩部318被压向第二心轴440的外表面。这样，如前所述，渐缩可植入装置100的期望的尺寸可在形成具有第二较短长度的渐缩部108之前选定。
压缩比可用于描述施加于具有第一较长长度的渐缩部318的纵向压缩量。例如，压缩比可包括具有第二较短长度的渐缩部108的长度与具有第一较长长度的渐缩部318的长度之比。在各种实施例中，压缩比可在约75％至95％之间。在其它实施例中，压缩比可在约50％至75％之间。在又一些其它实施例中，压缩比可在约25％至50％之间。压缩比的范围可低至约15％，且很大程度取决于所选多孔前体材料的体积密度。
在各种实施例中，压缩比可关联于具有第二较短长度的渐缩部108与具有第一较长长度的渐缩部318的对应各长度。例如，心轴比可包括第二较短长度的渐缩段448的长度与第一较长长度的渐缩段338的长度之比。优选地，压缩比和心轴比基本相同。在其它实施例中，心轴比在压缩比的10％以内(心轴比距压缩比在其10％以内)。在又一些其它实施例中，心轴比在压缩比的33％以内(心轴比距压缩比在其33％以内)。压缩比与心轴比之间的任何关联性都在本发明的范围内。
在各种实施例中，如图4C所示，阴模450可用于辅助形成具有第二较短长度的渐缩部108。例如，阴模450可以在第二较短渐缩长度段448处或附近将纵向压缩力施加至聚合物管状构件102，从而导致具有第一较长长度的渐缩部318压向第二心轴440的第二较短渐缩长度段448。阴模450可包括例如与第二心轴440的第二较短渐缩长度段448互补的形状。在其它实施例中，阴模450包括与第二较短渐缩长度段448不同的形状。在这样的实施例中，阴模450可辅助提供聚合物管状构件102的外表面上的期望的形状，包括具有第二较短长度的渐缩部108。
此外，阴模450可辅助提供聚合物管状构件102在较小直径区域104和/或具有第二较短长度的渐缩部108处的一致的厚度。辅助在多孔管状部件中形成具有第二较短长度的渐缩部108的阴模450的任何配置都在本发明的范围内。
在从第二心轴440移除聚合物管状构件102之前，构件102可暴露于进一步的加工步骤。例如，聚合物管状构件102的一部分、诸如具有第二较短长度的渐缩部108可被加热。进一步，热量可施加于整个第二心轴440和聚合物管状构件102。对包括具有第二较短长度的渐缩部108的聚合物管状构件102的任何处理都在本发明的范围内。
在形成具有第二较短长度的渐缩部108后，渐缩的可植入装置100可从第二心轴440中移除并被准备用于病人的解剖结构。在各种实施例中，渐缩的可植入装置100可与诸如例如支架之类的医疗装置相结合。在其它实施例中，渐缩可植入装置100可不与另一医疗装置结合使用。在这样的实施例中，渐缩可植入装置100可包括移植物。尽管对具体实施例进行了描述，但渐缩可植入装置100可单独使用或与任何合适的医疗装置结合使用，从而植入病人的解剖结构内。
前面的描述已经给出了许多特征和优点，包括各种替代的实施方式，以及装置和方法的结构和功能的细节。本文的意图是示例性的，并不是穷尽性的或限制性的。对于本领域的技术人员来说显然可对由所附权利要求所表达的术语的宽泛上位含义所指示的全部范围内做出各种改型，尤其是在结构、材料、元素、部件、形状、尺寸和部件的布置方面，包括这些方面在此处所描述的原理范围内的结合。在这些各种改型未偏离所附权利要求的精神和范围的程度内，意味着它们也包含于此。

Claims (17)

1.一种用于制造渐缩的可植入物件的方法，包括：
使用具有第一较长渐缩长度段的第一心轴，在ePTFE管状构件中形成具有第一较长长度的渐缩部；
将所述ePTFE管状构件从所述第一心轴移除；
在具有第二较短渐缩长度段的第二心轴上，将所述ePTFE管状构件的所述具有第一较长长度的渐缩部纵向压缩成具有第二较短长度的渐缩部；以及
将所述ePTFE管状构件从所述第二心轴移除。
2.如权利要求1所述的方法，其特征在于，压缩比包括所述具有第一较长长度的渐缩部与所述具有第二较短长度的渐缩部之比，且心轴比包括所述第一较长渐缩长度段的长度与所述第二较短渐缩长度段的长度之比，其中所述心轴比在所述压缩比的33％以内。
3.如权利要求2所述的方法，其特征在于，所述心轴比距所述压缩比在其10％以内。
4.如权利要求2所述的方法，其特征在于，所述压缩比和所述心轴比基本相同。
5.如权利要求1所述的方法，其特征在于，在ePTFE管状构件中形成具有第一较长长度的渐缩部的步骤包括将挤出的ePTFE管件拉至所述第一心轴上。
6.如权利要求1所述的方法，其特征在于，所述ePTFE管状构件包括多个原纤维，其中多数所述原纤维是弯曲的。
7.如权利要求1所述的方法，其特征在于，所述具有第一较长长度的渐缩部和所述具有第二较短长度的渐缩部包括等直径的横截面形状。
8.如权利要求1所述的方法，其特征在于，所述具有第二较短长度的渐缩部包括均匀的截头锥形。
9.如权利要求1所述的方法，其特征在于，所述具有第二较短长度的渐缩部包括不均匀形状。
10.如权利要求1所述的方法，其特征在于，所述方法还包括在所述第二心轴上纵向压缩所述ePTFE管状构件的所述渐缩部之后，加热所述ePTFE管状构件的步骤。
11.如权利要求1所述的方法，其特征在于，在所述第二心轴上纵向压缩所述具有第一较长长度的压缩部的步骤还包括：通过具有与所述第二较短长度段的形状所互补的形状的阴模来压缩所述ePTFE管状构件。
12.如权利要求1所述的方法，其特征在于，所述方法还包括如下步骤：在所述ePTFE管状构件的渐缩部为第一较长长度时，围绕所述ePTFE管状构件的至少一部分的腔外表面缠绕膜。
13.一种可植入物品，包括：
ePTFE管件，所述ePTFE管件包括具有第一直径的第一长度部和具有第二直径的第二长度部；以及
在所述第一长度部与所述第二长度部之间的渐缩长度部，其中，所述渐缩长度部包括多个基本弯曲的原纤维。
14.如权利要求13所述的可植入物品，其特征在于，所述ePTFE管件包括多个弯曲的原纤维。
15.如权利要求13所述的可植入物品，其特征在于，所述渐缩长度部包括不均匀形状。
16.如权利要求13所述的可植入物品，其特征在于，所述渐缩长度部包括均匀的截头锥形。
17.一种可植入物品，包括：
ePTFE管件，所述ePTFE管件包括具有较小直径的第一端部和具有较大直径的第二端部；以及
在所述第一端部与所述第二端部之间的渐缩长度部，所述渐缩长度部包括多个基本弯曲的原纤维。
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CN105793015B (zh) 2018-11-16
CN108992203A (zh) 2018-12-14
US9814560B2 (en) 2017-11-14
JP6530400B2 (ja) 2019-06-12
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