CN109641083A - 分层膜 - Google Patents

分层膜 Download PDF

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Publication number
CN109641083A
CN109641083A CN201780053648.7A CN201780053648A CN109641083A CN 109641083 A CN109641083 A CN 109641083A CN 201780053648 A CN201780053648 A CN 201780053648A CN 109641083 A CN109641083 A CN 109641083A
Authority
CN
China
Prior art keywords
film
layer
product component
coating
barrier layer
Prior art date
Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
Pending
Application number
CN201780053648.7A
Other languages
English (en)
Inventor
H·L·尼尔森
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
Coloplast AS
Original Assignee
Coloplast AS
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Application filed by Coloplast AS filed Critical Coloplast AS
Publication of CN109641083A publication Critical patent/CN109641083A/zh
Pending legal-status Critical Current

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Classifications

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    • A61L28/00Materials for colostomy devices
    • A61L28/0003Materials for colostomy devices containing inorganic materials
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    • A61L28/0026Mixtures of macromolecular compounds
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    • A61F5/44Devices worn by the patient for reception of urine, faeces, catamenial or other discharge; Portable urination aids; Colostomy devices
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Abstract

披露了一种分层阻挡膜,所述分层阻挡膜具有第一产品部件和第二可拆卸的载体部件。所述第一产品部件包括选自下组的材料的层以及由至少部分无机材料制成的第二层,该组包括聚乙烯、聚乙烯共聚物、聚丙烯共聚物、热塑性聚氨酯、热塑性聚酯弹性体、热塑性聚酰胺弹性体、热塑性弹性体化合物、和/或它们的共混物。所述第一产品部件具有高阻挡特性并且是非常柔软的。所述第二可拆卸的载体部件是选自包括以下各项的组的材料的层:聚乙烯、聚丙烯、聚酯、聚酰胺、和/或它们的共混物。

Description

分层膜
本披露涉及一种具有高阻挡特性和柔软度的分层膜。
背景技术
已经发现当前可获得的具有所希望的高阻挡特性的膜对于某些用途如医疗装置具有低劣的柔性或柔软度特性。
发明内容
披露了一种分层膜,所述分层膜包括第一产品部件和第二可拆卸的载体部件。所述第一产品部件包括第一基本层和第二阻挡层。所述分层膜被配置成具有高阻挡和柔软度特征并且适于在最终产品如医疗装置中的生产、处理、储存、运输和/或应用的过程中忍受物理影响如应力和应变。
附图说明
将附图包括在内以提供对实施例的进一步理解,并且其被结合在本说明书内并且是本说明书的一部分。附图展示了实施例并且与本说明书一起用于解释实施例的原理。将容易领会其他实施例和实施例的预期优点中的许多优点,因为通过参考以下详细说明它们将变得更好理解。附图的元件不一定相对于彼此成比例。相同的参考数字表示对应的类似部分。
图1-5是分层膜的实施例的示意性截面视图,
图6是结合分层膜的实施例的用于间歇性导尿管的套管的示意性视图,
图7是结合分层膜的实施例的用于间歇性导尿管的外壳包装的局部截面俯视图,
图8是结合分层膜的实施例的用于造口术器具的基板的示意性俯视图,
图9是结合分层膜的实施例的用于造口术器具的基板的示意性截面视图,
图10是结合分层膜的实施例的用于收集身体废液的袋的示意性平面视图,并且
图11是结合分层膜的实施例的图10的造口术器具的示意性截面视图。
具体实施方式
实施例提供一种分层膜,所述分层膜包括第一产品部件和第二可拆卸的载体部件。本披露的分层膜的实施例具有高阻挡和柔软度特征,而同时足够强以维持在生产设置中被处理和使用的物理效果。本披露的第一产品部件的实施例具有高阻挡和柔软度特征,而同时足够强以维持在生产设置中被处理和使用的物理效果。本披露的分层膜的实施例特别地,但非排他性地适合结合于医疗装置中。实施例提供了一种分层膜,所述分层膜具有对气体(如氧气、二氧化碳、水蒸气和其他气体,特别是在肠胃气胀中发现的气体)的高阻挡特性。实施例提供了一种分层膜,所述分层膜具有对液体和半固体(如水、盐水和人体分泌物(包括不同水含量的粪便))的高阻挡特性。实施例提供了一种分层膜,所述分层膜具有如此高阻挡特性或特征,而同时是非常柔软或柔性的。
图1是分层膜20的一个实施例的示意性截面视图。分层膜20包括第一产品部件22和第二可拆卸的载体部件24。第一产品部件22包括第一基本层26和第二阻挡层28。
在实施例中,第一基本层26包含选自由以下各项组成的组的材料:聚乙烯、聚乙烯共聚物、聚丙烯共聚物、热塑性聚氨酯、热塑性聚酯弹性体、热塑性聚酰胺弹性体、热塑性弹性体化合物、和/或它们的共混物。
在实施例中,第二阻挡层28包含至少部分无机材料。在实施例中,第二阻挡层28的至少部分无机材料选自由金属、纳米涂层、玻璃涂层、固化的聚硅氮烷和石墨烯构成的组。这些无机材料具有所希望的高阻挡特性。
第一产品部件22适于具有如根据美国标准ASTM D882测量的低于500MPa(N/mm2)的E-模量(杨氏模量)。第一产品部件22适于具有如根据ASTM F1249测量的低于3g/m2/24h(三克/平方米/24小时周期)的水蒸气透过率(WVTR)。
图2是分层膜20的一个实施例的示意性截面视图,其中第一基本层26包括多个单独的层26a、26b、26c。单独的层26a、26b、26c中的每一个包含一种或多种选自由以下各项构成的组的材料:聚乙烯、聚乙烯共聚物、聚丙烯共聚物、热塑性聚氨酯、热塑性聚酯弹性体、热塑性聚酰胺弹性体、热塑性弹性体化合物、和/或它们的共混物。
在实施例中,第二可拆卸的载体部件24包含选自由以下各项组成的组的材料:聚乙烯、聚丙烯、聚酯、聚酰胺、和/或它们的共混物。
在实施例中,第二可拆卸的载体部件24的第二E-模量大于第一产品部件22的第一E-模量。
在实施例中,分层膜20包括一个或多个支撑材料的层,所述层具有合适的机械稳定性,为分层膜20提供额外的支撑。在实施例中,所述支撑材料在高于70℃的温度下具有机械稳定性。在实施例中,所述一个或多个支撑材料的层被包括在第一产品部件22中。在实施例中,所述一个或多个支撑材料的层被包括在第二可拆卸的载体部件24中。在实施例中,一个或多个支撑材料的层被包括在第一产品部件22和第二可拆卸的载体部件24中的每一个中。在实施例中,所述一个或多个支撑材料的层包含高密度聚乙烯(HDPE)、聚丙烯(PP)和聚酯(PET)。
所述一个或多个支撑材料的层辅助提供分层膜20,以在结合第一产品部件22的产品或装置中的生产、处理、储存、运输和/或应用的过程中更好地忍受应力和应变。特别地,但非排他性地,所述支撑材料在生产工艺期间提供了增加的支撑,其中第二阻挡层28被提供作为涂层。
根据以上的实施例提供了分层膜20,所述分层膜具有高水平的源于第二阻挡层28的材料的阻挡特性,而同时更适合于一般处理并且被包含在进一步的生产步骤中。这些改进特别地提供了具有高阻挡特性的薄的至少部分无机阻挡材料要与高柔性和柔软度特性且被处理和加工的材料层组合的结合。特别地,但非排他性地,这在医疗装置的生产中是有利的。
本披露的实施例的优点包括提供特别适用于医疗装置的膜材料,所述膜材料具有高阻挡特性并且在医疗装置的整个完整(完全)加工周期中是可加工的。
在当前可获得的膜下,包含高阻挡特性材料要求相对刚硬或刚性的基材,如取向的聚丙烯或聚酯,因为这些高阻挡特性材料典型地对伸长和/或弯曲非常敏感。
不同于这些当前可获得的具有高阻挡特性的膜材料,根据本披露的分层膜20的第一产品部件22可以被制成非常柔性的和/或柔软的,因为第二可拆卸的载体部件24为分层膜20提供了有利的鲁棒性用于进一步工艺步骤(如包括医疗装置的制造)。此外,在实施例中,一旦要求本申请中所披露的分层膜20的鲁棒性的产品的生产工艺中的一个或多个步骤完成,可以去除第二可拆卸的载体部件24。
因此,本披露的分层膜20提供了一种用于将具有非常高阻挡特性的材料与具有高柔性度和/或柔软度的材料组合的解决方案。这被发现是非常有利的用于生产各种产品(包括医疗装置)。
受制于对结合分层膜20的第一产品部件22的产品的生产工艺和/或类型的依赖性,在结合第一产品部件22的产品的生产工艺中的在制造产品的过程中、在分层膜20的储存之前或之后、在处理分层膜20之前或之后、或通过产品(如医疗装置)的使用者在当他或她准备使用医疗装置时的情况下,第二可拆卸的载体部件24可以被拆卸或被去除。
图1和图2进一步展示了实施例,其中第二阻挡层28被附接到第一基本层26的主表面32上。
图3是展示分层膜20的一个实施例的示意性截面视图,其中分层膜20包括在第一基本层26与第二阻挡层28之间提供的第三粘合剂层30。在实施例中,第三粘合剂层30有助于提供第二阻挡层28到第一基本层26的加强的附接。在实施例中,第三粘合剂层30包含选自由以下各项组成的组的材料:聚乙烯、聚乙烯共聚物、聚丙烯共聚物、热塑性聚氨酯、热塑性聚酯弹性体、热塑性聚酰胺弹性体、热塑性弹性体化合物和/或它们的共混物。
在其他实施例中,第三粘合剂层30包含选自包括具有一个或多个官能侧基的聚合物的组的材料。在实施例中,所述官能侧基包括腈、羧酸盐、酸酐、醛、酮、醇、胺、酯、酰胺、羧酸、卤代烷烃和醚。发现这些材料在提供第一基本层26与第二阻挡层28之间的附接中良好地起作用。
图3进一步展示了分层膜20的实施例,其中第三粘合剂层30被附接到第一基本层26的主表面32上,并且第二阻挡层28被附接到第三粘合剂层30上。
在其他实施例中,代替提供第三粘合剂层30,通过电晕处理、火焰处理或等离子体处理预处理第一基本层26的主表面32。所述预处理可以有利地在施用第二阻挡层28之前在分离工艺中进行。以此可替代的方式,第二阻挡层28可以被直接附接到主表面32上。在实施例中,这提供了简单的生产工艺和简单的中间产品。
在实施例中,分层膜20包含一种或多种选自包括以下各项的组的添加剂:抗氧化剂、着色剂、加工添加剂、释放添加剂以及防结块添加剂。在图3中,添加剂在36处表示为结合于第一基本层26中。然而,应理解的是一种或多种添加剂可以被结合于第一产品部件22的任一层中。在其他实施例中,一种或多种添加剂36被提供于一个或多个额外的添加剂层(未示出)中。
在实施例中,第二可拆卸的载体部件24被可拆卸地附接到第一基本层26的次表面34上。在一种定义中,“可拆卸地附接到”旨在反映第二可拆卸的载体部件24可以以任何方式从第一基本层26的次表面34中去除,而不破坏或损坏第一产品部件22。此外,在额外的或可替代的定义中,可拆卸的附接意指仅需要相对小的力来分开部件。
在实施例中,第二可拆卸的载体部件24和第一基本层26被配置成彼此具有一些相容性或亲和力,意指它们之间的弱化学力倾向于使它们相互结合。在实施例中,在第二可拆卸的载体部件24与第一基本层26之间的附接度受控于生产工艺中,如通过选择材料的聚合物、加工参数和功能添加剂。在实施例中,配置第二可拆卸的载体部件24和第一基本层26的材料、和/或工艺参数,使得第二可拆卸的载体部件24和第一基本层26不能永久地相互附接。
在实施例中,用弱的胶粘剂附接第二可拆卸的载体部件24。在实施例中,第二可拆卸的载体部件24仅被附接到次表面34的一个或多个部分上,如在多个不同的区域中,每个区域提供相对小的表面之间的接触面积。可拆卸地或可释放地将第二可拆卸的载体部件24附接到第一基本层26的次表面34上的其他方式是可接受的,前提是它们符合以上陈述的定义。
在实施例中,第二阻挡层28被提供作为涂层。特别地,但非排他性地,这提供了第二阻挡层28,所述第二阻挡层是非常薄的、同时还是具有高或甚至极高的阻挡特性的材料,如在本披露中的其他地方提到的至少部分无机材料。在实施例中,可以通过以下技术将第二阻挡层28的涂层施用到第一基本层26的主表面32或第三粘合剂层30上:物理或化学气相沉积,喷涂,卷对卷涂覆或其他化学、电化学或机械技术,包括阻挡材料和基材材料的共挤出。
在实施例中,第一产品部件22的厚度t(图1)低于100μm。第一产品部件22的厚度t将自然地影响第一产品部件22的E-模量。多个不同的具有低于100μm的第一基本层26与第二阻挡层28的组合厚度t的实施例是通过改变第一基本层26和第二阻挡层28的单独厚度的分布来提供的。在实施例中,第一基本层26的厚度是在10-90μm,如20-80μm、如30-70μm、如40-60μm的范围内,如50μm。取决于第一产品部件22的所需特定特征,选择第一基本层26和第二阻挡层28的单独厚度如此以致也满足小于100μm的组合厚度的限制。换言之,在实施例中,第二阻挡层28的厚度可以变化,从而也为适合于进一步生产(如适合于医疗装置)的非常柔软、高阻挡特性膜提供阻挡特性选项的“子范围”。
在实施例中,如根据美国标准ASTM D3985测量的,第一产品部件22的氧气透过率OTR低于100cm3/m2/24h。特别地,但非排他性地,第二阻挡层28的厚度可适于使得第一产品部件22满足100cm3/m2/24h的OTR限制。假如具有此特征的第一产品部件22呈现出膜,则所述膜特别良好地适合于用于身体废液的收集袋(如用于收集粪便物或尿的袋)的壁的目的。
在实施例中,第一产品部件22的第一基本层26通过流延膜挤出工艺来制造。在其他实施例中,第一产品部件22的第一基本层26通过吹塑膜挤出工艺来制造。在将分层膜20的第一产品部件22施用于产品(如医疗装置)中的情况下,可以根据产品要求选择膜挤出工艺。吹塑膜典型地比流延膜更坚韧并且更耐穿刺。另一方面,流延膜典型地是澄清且透明的,允许它们用于封闭产品,其中视觉标识具有重要性。在实施例中,第一基本层26包括特别适合于用于身体废液的收集袋的吹塑膜。在另一个实施例中,第一基本层26包括特别适合于用于间歇性导尿管的套管的流延膜。在又其他实施例中,第一基本层26包括特别适合于用于间歇性导尿管的套管的吹塑膜。
在实施例中,第三粘合剂层30包含选自由以下各项组成的组的材料:聚乙烯、聚乙烯共聚物、聚丙烯共聚物、热塑性聚氨酯、热塑性聚酯弹性体、热塑性聚酰胺弹性体、热塑性弹性体化合物、和/或它们的共混物。发现这些材料在提供第一基本层26与第二阻挡层28之间的附接中良好地起作用。
图4是分层膜20的一个实施例的示意性截面视图,其中第二阻挡层28包括一个或多个选自包括以下各项的组的保护层29:聚合物涂层、纳米涂层以及聚硅氮烷涂层。一个或多个保护层29在生产和使用的过程中针对第二阻挡层28的阻挡材料27的损坏提供了额外的安全性。
在实施例中,第二阻挡层28的涂层包括多个单独的阻挡层。图4进一步展示了实施例,其中多个单独的阻挡层27可交换地或交替性地安排有多个保护层29。在一个实施例中,第二阻挡层28被提供作为层压板,所述层压板由多个至少部分无机阻挡材料27以及一个或多个保护层29组成,所述无机阻挡材料选自由金属、陶瓷、纳米涂层、固化的聚硅氮烷和石墨烯构成的组,所述保护层选自包括聚合物涂层、纳米涂层以及固化的聚硅氮烷涂层的组。在实施例中,当第一基本层26的柔性没有受损时,在涂层表面中不可避免地形成针孔的不利影响被最小化。由此,发现第二阻挡层28的此层压板配置提供了特别稳健的第二阻挡层28,特别有利于生产具有高阻挡特性并且是非常薄且柔软的膜。
在实施例中,用于第二阻挡层28的合适的金属包括铝、铬、铜等。合适的陶瓷材料包括氧化物,如但不限于,氧化硅(SiOx)、氧化铝(AlOx)和氧化钛(TiOx)。合适的纳米涂层包括一类基于化学纳米技术的无机-有机杂化聚合物的材料,从德国弗劳恩霍夫公司(Fraunhofer)可获得的。其他合适的纳米涂层包括来自新加坡特拉阻挡膜公司(Tera Barrier Films,ltd.)的Tera-Barrier以及来自荷兰合适的聚硅氮烷包括通过用水(H2O)和热处理固化的、或通过紫外线(UV)辐射固化的全氢聚硅氮烷(无机的)和有机聚硅氮烷(有机的)两者。在实施例中,第二阻挡层28的涂层包括从澳大利亚安姆科公司(Amcor,ltd.)可获得的涂层。
在实施例中,第二阻挡层28包含纳米黏土。在实施例中,第二阻挡层28包含一种或多种板形填充剂材料。
图5是分层膜20的一个实施例的示意性截面视图,其中分层膜20的第一产品部件22包括交替性地安排的多个第一基本层26a、26b、26c,多个第二阻挡层28a、28b、28c以及任选地多个第三粘合剂层30(未示出)。这些实施例为高阻挡特性膜以及促进更稳健的产品提供了另外的选项。
图6是用于间歇性导尿管42的套管40的示意性视图,套管40包括本文所披露的分层膜20的第一产品部件22。在实施例中,套管40限定了用于储存导管42的可打开的隔室44的至少一部分。在实施例中,用亲水性涂层涂覆导管42。在实施例中,套管40被配置成还包含用于活化在导管42上的亲水性涂层的部件。在实施例中,用于活化在导管42上的亲水性涂层的部件是液体46。
图7是用于间歇性导尿管52的外壳包装50的局部截面俯视图,外壳包装50包括本文所披露的分层膜20的第一产品部件22。在实施例中,外壳包装50限定了用于储存导管52的可打开的隔室54的至少一部分。在实施例中,用亲水性涂层53涂覆导管52。在实施例中,外壳包装50被配置成还包含用于活化在导管52上的亲水性涂层53的部件55。在实施例中,用于活化在导管52上的亲水性涂层53的部件55包含液体56。
图8是用于造口术器具的基板62的示意性俯视图,并且图9是示意性截面视图,基板62包括一个或多个本文所披露的分层膜20的第一产品部件22的层60。在实施例中,基板62包含由层60支撑的并且在施用之前由释放衬层64保护的胶粘剂材料66。还展示了造口术接收开口68。
图10是用于收集身体废液的袋72的示意性平面视图,收集袋72包括一个或多个本文所披露的分层膜20的第一产品部件22的层70。在实施例中,收集袋72被附接到基板74上以形成造口术器具76。
图11是图10的造口术器具76的示意性截面视图,其包括形成用于收集离开造口S的造口废物的袋72的第一产品部件22的两层70a、70b。在实施例中,收集袋72的层70a被附接到基板74的顶部膜层75上。在实施例中,顶部膜层75包括分层膜20的第一产品部件22。
进一步披露的是一种用于创伤敷料的背衬部件,所述背衬部件包括分层膜20的第一产品部件22的一个或多个层。

Claims (23)

1.一种分层膜,其包括第一产品部件和第二可拆卸的载体部件,所述第一产品部件包括:
-第一基本层,所述第一基本层包含选自由以下各项组成的组的材料:聚乙烯、聚乙烯共聚物、聚丙烯共聚物、热塑性聚氨酯、热塑性聚酯弹性体、热塑性聚酰胺弹性体、热塑性弹性体化合物、和/或它们的共混物;和
-第二阻挡层,所述第二阻挡层包含至少部分无机材料,
其中所述第一产品部件的E-模量(ASTM D882)低于500MPa并且所述第一产品部件的水蒸气透过率WVTR(ASTM F1249)低于3g/m2/24h,并且
其中
-所述第二可拆卸的载体部件包含选自由以下各项组成的组的材料:聚乙烯、聚丙烯、聚酯、聚酰胺、和/或它们的共混物。
2.如权利要求1所述的膜,进一步包括在所述第一基本层与所述第二阻挡层之间提供的第三粘合剂层。
3.如权利要求1所述的膜,其中,所述第二阻挡层被附接到所述第一基本层的主表面上。
4.如权利要求2所述的膜,其中,所述第三粘合剂层被附接到所述第一基本层的主表面上,并且所述第二阻挡层被附接到所述第三粘合剂层上。
5.如权利要求1所述的膜,其中,所述第二可拆卸的载体部件被可拆卸地附接到所述第一基本层的次表面上。
6.如权利要求1所述的膜,其中,所述第二阻挡层的至少部分无机材料选自包括以下各项的组:金属、陶瓷、纳米涂层、玻璃涂层、固化的聚硅氮烷以及石墨烯。
7.如权利要求1所述的膜,其中,所述第二阻挡层被提供作为涂层。
8.如权利要求1所述的膜,其中,所述第一产品部件的厚度低于100μm。
9.如权利要求1所述的膜,其中,所述第一产品部件的氧气透过率OTR(ASTM D3985)低于100cm3/m2/24h。
10.如权利要求2所述的膜,其中,所述第三粘合剂层包含选自由以下各项组成的组的材料:聚乙烯、聚乙烯共聚物、聚丙烯共聚物、热塑性聚氨酯、热塑性聚酯弹性体、热塑性聚酰胺弹性体、热塑性弹性体化合物、和/或它们的共混物。
11.如权利要求2所述的膜,其中,所述第三粘合剂层包含选自包括具有一个或多个官能侧基的聚合物的组的材料。
12.如权利要求1所述的膜,其中,所述第二阻挡层进一步包括一个或多个选自包括以下各项的组的保护层:聚合物涂层、纳米涂层以及固化的聚硅氮烷涂层。
13.如权利要求1所述的膜,其中,所述第二阻挡层被提供作为层压板,所述层压板由其材料在至少部分无机阻挡材料之间交替的多个层以及一个或多个保护层组成,所述无机阻挡材料选自由金属、陶瓷、纳米涂层、固化的聚硅氮烷和石墨烯构成的组,所述保护层选自包括聚合物涂层、纳米涂层以及固化的聚硅氮烷涂层的组。
14.如权利要求1所述的膜,进一步包含一种或多种选自包括以下各项的组的添加剂:抗氧化剂、着色剂、加工添加剂、释放添加剂以及防结块添加剂。
15.如权利要求15所述的膜,其中,所述一种或多种添加剂被提供于一个或多个额外的层中。
16.如权利要求1或2中任一项所述的膜,其中,所述第一产品部件包括多个交替性地安排的第一基本层、第二阻挡层和任选地第三粘合剂层。
17.如权利要求1所述的膜,其中,所述可拆卸的载体部件的第一E-模量大于所述第一产品部件的第二E-模量。
18.如权利要求1所述的膜,进一步包含在高于70℃的温度下具有机械稳定性的支撑材料。
19.一种用于亲水性涂覆的间歇性导尿管的套管,所述套管包括如前述权利要求中任一项所述的分层膜的第一产品部件。
20.一种用于亲水性涂覆的间歇性导尿管的外壳包装,所述外壳包装包括如权利要求1-19中任一项所述的分层膜的第一产品部件。
21.一种用于收集身体废液的袋,所述收集袋包括一个或多个如权利要求1-19中任一项所述的分层膜的第一产品部件的层。
22.一种用于创伤敷料的背衬部件,所述背衬部件包括一个或多个如权利要求1-19中任一项所述的分层膜的第一产品部件的层。
23.一种用于造口术器具的基板,所述基板包括一个或多个如权利要求1-19中任一项所述的分层膜的第一产品部件的层。
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WO2018041320A3 (en) 2018-07-05
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