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CN103522693A - 柔韧层压制品和用于其制造的方法 - Google Patents

柔韧层压制品和用于其制造的方法 Download PDF

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CN103522693A
CN103522693A CN201310336411.3A CN201310336411A CN103522693A CN 103522693 A CN103522693 A CN 103522693A CN 201310336411 A CN201310336411 A CN 201310336411A CN 103522693 A CN103522693 A CN 103522693A
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layer
parylene
elastomer
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flexible laminate
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CN103522693B (zh
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D·多尼登
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Otto Bock Healthcare GmbH
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Abstract

一种柔韧层压制品，由第一柔韧弹性体的至少一个第一层(4)和由第二柔韧弹性体制成的一个第二层(5)形成，所述至少一个第一层和所述第二层利用一中间层彼此连接，为了制造该柔韧层压制品而将一帕利灵层这样地施加到所述第一层(4)上：使得所述帕利灵层具有由不规则表面引起的表面粗糙度；将所述第二弹性体或者与所述第二层(5)结合的胶粘剂以液态形式这样地施加到所述帕利灵层上，使得至少部分地填充所述帕利灵层的表面的不规则处。

Description

柔韧层压制品和用于其制造的方法
技术领域
本发明涉及一种柔韧层压制品，它由第一柔韧弹性体的至少一个第一层和由第二柔韧弹性体制成的一个第二层形成，所述至少一个第一层利所述第二层利用施加到所述第一层上的中间层彼此连接。
本发明另外还涉及一种用于制造柔韧层压制品的方法，该柔韧层压制品由第一柔韧弹性体的至少一个第一层和由第二柔韧弹性体制成的一个第二层形成，所述至少一个第一层和所述第二层利用施加到所述第一层上的中间层彼此连接。
背景技术
已公知的是，一定的弹性塑料材料不能彼此顺利连接。因此例如不可行的是，一硅酮层和一聚氨酯层相互之间直接或者利用粘接物质连接。因此，硅酮的覆层始终有问题。
热塑性弹性体的覆层也有类似的问题，比如当该热塑性弹性体例如在苯乙烯-异戊二烯-丁二烯-嵌段共聚物(Styrol-Isopren-Butadicn-Blockcopolymere)或者苯乙烯-乙烯/丁烯共聚物(Styrol-Ethylen/Butylen-copolymer)的基础上形成时。这些热塑性弹性体(TPE)可以具有高的油含量，与其它材料的面式连接由于该油含量而变得有问题。
由US2009/0240344A1公开了利用织物中间层来连接材料，所述织物中间层能与两种材料连接。不过由此，所形成的层压制品会失去柔韧性。此外增加了层厚度。另外从该文件中还公开了：多个层中的一个层设有例如大量钩子形式的经纹理化的表面，以便由此获得由另一塑料材料制成的、然后被注塑的层的机械式钩挂。这类方法是费事的。
由DE2617678A1公开了一种由两种聚合组份来制造聚合物连接材料，其中一种聚合组份是硫化橡胶，而另一种则是另一不同的硫化橡胶或塑料。所述聚合组份的连接通过如下方式建立：在这些组份的分界面上设置微粒形的结合层，该结合层主要包含碳和/或硅化合物的微粒。该层由两种组份渗透。
由DE102008063818A1公开了：一种矫形外科的垫由经流体填充的弹性体、弹性体凝胶、软化的热塑性塑料或聚氨酯制成，该矫形外科的垫设有减少摩擦的层，其方式是，经聚合的垫至少经受一个预处理步骤，在该预处理步骤中将挥发性的组成部分从表面除去并且接着将所述垫以一无极性的、提升滑移性的聚合物覆层来覆层。所述聚合的覆层材料可以在此是聚对二甲苯(常见的俗称：帕利灵(Parylen))。
发明内容
本发明的任务在于可以实现使第一柔韧弹性体与第二柔韧弹性体面式地连接成一柔韧层压制品，其中，柔韧性不由于所述中间层而受到明显影响并且通过所述中间层不需要显著增大所述层压制品的厚度。
为了解决该任务，开头提及类型的柔韧层压制品的特征在于：所述中间层是一具有不规则表面的帕利灵层；所述第二弹性体或者与所述第二层结合的胶粘剂至少部分地填充所述帕利灵层的表面的不规则处。
另外，该任务利用一种开头提及类型的方法通过如下方式来解决：一帕利灵层施加到所述第一层上，从而使得所述帕利灵层通过化学气相沉积法(CVD)这样地施加，使得所述帕利灵层具有由不规则表面引起的表面粗糙度；将所述第二弹性体或者与所述第二层结合的胶粘剂以液态形式这样地施加到所述帕利灵层上，使得至少部分地填充所述帕利灵层的表面的不规则处。
因此，根据本发明应用了一种起到附着中介作用的帕利灵层。这是令人吃惊的，因为帕利灵公知为减少摩擦的材料，该材料由此在它的表面上允许仅很少的附着。
但是本发明基于这样的认识：所述帕利灵层、尤其是当其以化学气相沉积法(Chemical Vapor Deposition)被施加时可构造一不规则的表面。这样形成的表面不会妨碍摩擦系数由于帕利灵面的减小，但是可以为液态弹性体实现不规则处的填充，从而使得以液态形式的第二弹性体或者与所述第二弹性体的第二层结合的、以液态形式的胶粘剂能够与所述帕利灵层的表面钩挂并且因此造成所述第二层与所述第一层的主要以机械方式的连接。所述不规则处可具有侧凹部，这些侧凹部支持材料彼此的钩挂。这些侧凹部在此也可以通过那些从表面向材料内部去增大的微孔形成。此外，在以化学气相沉积法施加所述帕利灵层时形成这样的表面，该表面具有由彼此交错的沟槽所形成的、不规则的、类似格栅的结构，所述沟槽同样造成或至少支持所述层与层彼此的机械连接。
已证明的是，很难去覆层的第一弹性体可以稳定地利用帕利灵来覆层，特别是如果所述帕利灵层通过化学气相沉积法被施加到所述第一层上的话。因此，硅酮和热塑性弹性体尤其能够直接覆层一帕利灵层，其中，当第二弹性体或所述胶粘剂渗入到所述帕利灵层的不规则处中时，所述帕利灵层基于其不规则处至少也建立了与第二弹性体或与该第二弹性体结合的胶粘剂的机械连接。
因此需要将第二弹性体或者建立与该第二弹性体的结合的胶粘剂以液态形式施加到覆层有帕利灵层的第一弹性体上，从而使得到不规则处中的渗入可以实现并且所述第二弹性体或所述胶粘剂至少部分地填充所述不规则处。当所述不规则处具有例如以呈微孔状的间隙形式的侧凹部时，在此尤其会形成钩挂式连接。
第一弹性体优选是硅酮或热塑性弹性体。该第一弹性体优选通过化学气相沉积法以所述帕利灵层来覆层。由此，该第一弹性体能与第二弹性体连接。
作为第二弹性体尤其考虑聚氨酯或热塑性弹性体，为此，热塑性弹性体作为第二弹性体，尤其硅酮作为第一弹性体的应用是优选的。尤其是对于作为第二弹性体的热塑性弹性体可以是有意义的是：第二弹性体同样以一帕利灵层优选通过化学气相沉积法来覆层；然后将被覆层的第一弹性体和被覆层的第二弹性体以一适当的胶粘剂、尤其是聚氨酯胶粘剂来连接。
施加到所述第一层上的帕利灵层优选具有在0.4和5μm之间、进一步优选在0.7和4μm之间、尤其在0.7和2μm之间的厚度。在此，所述帕利灵层可以在其薄的情况下在一次性的施加中借助于化学气相沉积法来施加，而对于较大的层厚度两次或者三次的覆层是有意义的。对于0.7μm的小的层厚度，在一实施例中达到了Rz值11.4和对于平均粗糙度Ra的1.49的值。在三次覆层的情况下得到1.56μm的层厚度，该层厚度导致Rz值为30.9和Ra值为3.67。
在所述优选的层厚度区域中，两个由弹性体制成的层的弹性没有由于中间层而被显著减小。当为了与所述第二弹性体、与通过所述帕利灵层覆层的第一弹性体的连接而应用优选基于聚氨酯而制造的胶粘剂时，这也是适用的。
作为帕利灵(聚对二甲苯)尤其可以考虑帕利灵N作为根据本发明的附着中介。实验表明，变型方案帕利灵F和帕利灵C能够几乎相同地使用。
根据本发明的柔韧层压制品可用作扁平材料或预成型材料。两种弹性体彼此连接成柔韧层压制品提供了如下优点：能够将两种弹性体的不同优点应用在一层压制品中。因此，聚氨酯层的良好适配性可以与硅酮层的良好复位性能(Rückstelleigenschaft)和相对不灵敏性(Unempfindlichkeit)组合。类似地，可以将具有很高白油含量的热塑性弹性体的良好的皮肤亲和性与硅酮层的机械稳定性及抗断强度结合。因此，优选的组合是用硅酮作第一弹性体而聚氨酯作第二弹性体和TPE作第一弹性体而硅酮作第二弹性体。
根据本发明的柔韧层压制品的特别优选的应用是用作针对假肢的衬管，所述假肢替代截去的肢体。所述假肢的联接在此通过一假肢杆(Prothesenschaft)来进行，该假肢杆例如在假腿情况下的小腿上或大腿上包围一截肢残端。所述衬管被安置、例如由于该衬管的弹性卷套到所述截肢残端上，以便稳固地贴靠在截肢残端上并适配所述截肢残端的不规则处。由此，所述衬管例如直接处在所述截肢残端的皮肤上并且因而应当具有良好的皮肤亲和内层。该内层例如可以由聚氨酯或TPE制成。如果所述衬管如其利用根据本发明的柔韧层压制品而可行的那样具有例如由硅酮制成的外层，则硅酮提供该衬管的力学上稳定的外层，该外层此外具有良好的复位能力，以便因此将由聚氨酯或TPE制成的缓冲(polsternde)的内层按压到所述截肢残端上，由此，所述内层适配所述截肢残端的表面的不规则处。
在某些情况中也可以是有意义的是，聚氨酯或TPE的缓冲特性利用硅酮的复位特性通过如下方式来充分使用：对皮肤友好的并易于清洁的硅酮形成所述衬管的内层并且由聚氨酯或TPE制成的缓冲的弹性体层形成外层。在该情况下接下来可以是有意义的是，所述外层例如通过织物层或帕利灵覆层而设有一滑动层，所述滑动层然后并不根据本发明起附着中介的作用，而是像现有技术中公知的那样起到滑动层的作用。通过该滑动层例如可以使得设有衬管的截肢残端到假肢杆中的引入或所述截肢残端由所述假肢杆的去除变得容易。
为了所述应用而优选如下热塑性弹性体，所述热塑性弹性体是一般基于SEBS(苯乙烯-乙烯/丁烯-苯乙烯(Styrol-Ethylen/Butylen-Styrol))或SIBS(苯乙烯-异戊二烯/丁二烯-苯乙烯(Styrol-Isopren/Butadien-Styrol))的热塑性弹性体，尤其是苯乙烯-异戊二烯-丁二烯-嵌段共聚物或者苯乙烯-乙基/丁基聚合物。这类可考虑的TPE例如是英国AlphaGery有限公司的Evopren-TPE复合物、德国KRATON Polymers公司的SEBS G系列的聚合物和德国Kuraray Europe公司的Septon4044。
附图说明
附图中示出了根据本发明的柔韧层压制品的以衬管形式的实施例。在附图中：
图1示出了由根据本发明的柔韧层压制品制成的衬管的纵剖图；
图2示出了根据图1的衬管的一种变型方案的放大纵剖截段；
图3示出了根据图2的衬管的纵剖图。
具体实施方式
图1中示出的衬管具有一敞开的近端端部1、一封闭的远端端部2以及一在端部1、2之间基本上呈圆柱体形或大致锥形走向的中间段3。
衬管包括由第一弹性体、例如硅酮制成的在外的第一层4和由对皮肤友好的第二弹性体、例如聚氨酯制成的在内的第二层5。可以看到，第二层5向远端端部2去地在厚度上增加，以便向远端部去地改善截肢残端的缓冲并且确保了较高的舒适性。
在衬管的整个长度上，第一层4和第二层5可以彼此面式连接。
该面式连接可以在此完全或仅部分包括第一层和第二层的彼此贴靠的面。因此而足够的是，第一层4和第二层5只部分地例如以条带形式或通过在所述面上分布的连接点来彼此连接。该变型方案尤其在使用胶粘剂的情况下显而易见。
该面式连接可以通过如下方式来实现：所述第一层4以未示出的具有不规则表面的、尤其是以化学气相沉积法制成的作为中间层的帕利灵层来覆层。当所述帕利灵层以化学气相沉积法来施加时，其具有类似烧结的结构，该结构带有微孔状的、向材料内部扩展的间隙，而这些间隙起到侧凹部的作用。当第二层在此以第一层的形式形成时，例如由聚氨酯制成的第二层5然后可以直接、即没有胶粘剂地被施加到经覆层的第一层上，从而使得第二层5的第二弹性体以液态形式与第一层4的由帕利灵层所形成的内侧面接触。由此，第二层5的第二弹性体的液态材料可以部分地渗入到被施加的帕利灵层的不规则处中并且因此引起在第二层5与第一层4之间的稳固连接。
但是也可行的是，第二层5以与第一层4相互补的形式预制造并在已成型的状态下被粘接到第一层4中。在此应用一种胶粘剂，该胶粘剂一方面与第二层5的第二弹性体形成稳固的连接并且另一方面在液态状态下渗入到第一层4的内侧面上的帕利灵层的微孔中。
尤其在第二层5与第一层4的所描述的粘接的情况下可以实现图2和图3中所示的变型方案，在这两个变型方案中，所述粘接面式地在远端端部2与外壳区域3的大部分上进行，但是向所述近端端部去地在图1中的区域A中终止，从而使得向近端端部去地，作为在外的层的第一层4与作为在内的层的第二层5相互之间不连接，如这可在图2的放大示图中通过在外的第一层4与在内的第二层5之间的间隙6所看到的那样。如图3示出的那样而可行的是，在外的第一层4在两个层4、5彼此没有面式连接的区域中，也就是在间隙6的区域中向外翻转，以便例如造成(未示出的)假肢杆的近端边缘的密封，如果应当在衬管与假肢杆之间产生负压的话，通过该负压将假肢杆保险地在设有所述衬管的截肢残端上在使用中保持。
图3示出，层4、5之间的连接可借助于胶粘剂7进行。
已证明的是，通过根据本发明的帕利灵中间层，彼此间本不能连接的弹性体也能相互稳固地连接而且经受在0.2与1.4N/mm之间的剪切力。该连接力已足以用于作为衬管的应用，该连接力但是在没有根据本发明的帕利灵中间层的情况下在如硅酮-聚氨酯、TPE-硅酮和TPE-聚氨酯那样的材料对的连接中不能实现，因为在这些材料对的情况下没有明显的附着作用被实现。

Claims (10)

1.柔韧层压制品，其由第一柔韧弹性体的至少一个第一层(4)和由第二柔韧弹性体制成的一个第二层(5)形成，所述至少一个第一层和所述第二层利用施加到所述第一层(4)上的中间层彼此连接，其特征在于，所述中间层是一具有不规则表面的帕利灵层；所述第二弹性体或者与所述第二层(5)结合的胶粘剂至少部分地填充所述帕利灵层的表面的不规则处。
2.根据权利要求1所述的柔韧层压制品，其特征在于，所述帕利灵层通过化学气相沉积法施加到所述第一层(4)上。
3.根据权利要求1或2所述的柔韧层压制品，其特征在于，所述第一层(4)由硅酮或热塑性弹性体(TPE)制成。
4.根据权利要求1至3之一所述的柔韧层压制品，其特征在于，所述第二层(5)由聚氨酯或TPE制成。
5.根据权利要求1至4之一所述的柔韧层压制品，其特征在于，所述柔韧层压制品构造成用于假肢的衬管。
6.根据权利要求5所述的柔韧层压制品，其特征在于，所述第二层(5)形成内层，所述内层由所述第一层(4)从外部覆盖。
7.用于制造柔韧层压制品的方法，所述柔韧层压制品由第一柔韧弹性体的至少一个第一层(4)和由第二柔韧弹性体制成的一个第二层(5)形成，所述至少一个第一层和所述第二层利用一中间层彼此连接，其特征在于，将一帕利灵层这样地施加到所述第一层(4)上，使得所述帕利灵层具有由不规则表面引起的表面粗糙度；将所述第二弹性体或者与所述第二层(5)结合的胶粘剂以液态形式这样地施加到所述帕利灵层上，使得至少部分地填充所述帕利灵层的表面的不规则处。
8.根据权利要求7所述的方法，其特征在于将硅酮或TPE应用于所述第一层(4)。
9.根据权利要求7或8所述的方法，其特征在于将TPE或聚氨酯应用于所述第二层(5)。
10.根据权利要求7至9之一所述的、用于制造柔韧层压制品的方法，所述柔韧层压制品的形式是用于假肢的衬管。
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