CN1230293C - 用于可流动物质容器的端口管及密封件构成、结构和组件 - Google Patents

用于可流动物质容器的端口管及密封件构成、结构和组件 Download PDF

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CN1230293C
CN1230293C CNB028035313A CN02803531A CN1230293C CN 1230293 C CN1230293 C CN 1230293C CN B028035313 A CNB028035313 A CN B028035313A CN 02803531 A CN02803531 A CN 02803531A CN 1230293 C CN1230293 C CN 1230293C
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copolymer
styrene
pipe
ethylene
weight
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CN1486243A (zh
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林忠建
威廉·S·赫斯特
吴力弓
阿尔吉尔达斯·宾多卡斯
帕特里克·T·瑞安
斯各特·D·艾德华兹
汉克·P·布洛姆
阿图尔·R·哈列
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Baxter International Inc
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Abstract

本发明提供了一个具有端口管和膜管的可流动物质容器密封件组件。所述端口管有第一层和第二层，第一层是共混聚合物，第二层共轴心配置在第一层内；膜管共轴心配置在端口管内，膜管具有外层、中间层和内层。

Description

用于可流动物质容器的端口管及密封件构成、结构和组件
技术领域
本发明主要涉及用于可流动物质容器的密封件，特别是医疗液体容器的端口管组件。
本发明背景
通过静脉或者肠道向病人输入液体作为不同医疗状况下病人治疗的方法，是一种普通的医疗实践。向病人输入的液体通常装在柔性容器内。制作柔性容器的方法之一是将柔性材料的两张片材在片材外围附近密封，形成密封不透水的器室。为了使液体腔和容器外部形成连通，以向容器输入或从容器向外配送液体提供途径，端口管组件通常在密封时安装在片材之间。端口管组件一般包括一个固定在容器的侧壁上的外端口管，和与端口管共轴心配置的第二种管，称为膜管。膜管中有一个膜或隔膜片对端口管组件密封。通常用输液设备的针头刺破膜，使容器内的物质与病人流体连通。
端口管和膜管由单层或多层材料组成。端口管通常有一聚氯乙烯内层，膜管有一PVC外层。为了安装端口管组件，膜管浸渍于环己酮或其它合适的溶剂中，然后将其以可伸缩的方式插入到端口管中。溶剂会将端口管和膜管的PVC熔融，从而使膜管密封到端口管上。
许多医疗物品生产厂在用不含PVC的材料取代PVC材料方面已经做了大量的努力。柔性PVC容器中含有已知为增塑剂的低分子量添加剂，它可以渗出进入到容器所装的液体中。美国专利No.5,998,019和5,849,843公开了用不含PVC的材料取代医疗液体容器中的PVC材料。这些专利引入本文作为参考并作为本发明的一部分。
美国专利No.5,356,709公开了用非PVC材料共挤塑制备的医疗等级的端口管，这种管具有一聚丙烯和SEBS共混物外层，一粘结层和一聚酰胺和EVA共混物中间层。该专利已转让给与本发明相同的受让人。
美国专利No.5,533,992公开了一种非PVC材料，用于制备医疗管材和医疗容器,该专利已转让给与本发明相同的受让人。992号专利中公开的用于制造医疗管材的共混聚合物包括与下面一种或几种共混的聚氨酯：EVA、SEBS、PCCE和热塑性共聚酯弹性体。
本发明概要
该发明提供了非PVC端口管、非PVC膜管和非PVC端口管组件，用于可流动物质容器，如医疗和食物容器。
多层的不含PVC的管子，它包括：
第一层，它是以下物质形成的共混聚合物：(a)按重量计占第一层25％至50％的第一聚烯烃，所述聚烯烃选自聚丙烯和聚丙烯共聚物，(b)按重量计占第一层1％至50％的第二聚烯烃，所述聚烯烃选自乙烯共聚物、聚丁烯、聚丁二烯和；(c)按重量计占第一层1％到40％的射频敏感聚合物，其选自聚酰胺、乙烯丙烯酸共聚物、乙烯甲基丙烯酸共聚物、聚酰亚胺、聚氨酯、聚酯、聚脲、其乙酸乙烯酯共聚单体含量按重量计占共聚物12％-50％的乙烯乙酸乙烯酯共聚物、其丙烯酸甲酯共聚单体含量按重量计占共聚物12％-40％的乙烯丙烯酸甲酯共聚物、其乙烯醇共聚单体含量按摩尔百分比计占共聚物12％-70％的乙烯乙烯醇；(d)占1％至40％的第一热塑弹性体；和
在第一层内共轴心配置的第二层，它是仅由苯乙烯和二烯类共聚物组成的第二热塑弹性体。
密封件组件包括一端口管和与其共轴心安装的膜管。端口管有第一层和第二层。第一层是多组分共混聚合物，其中第一种组分的量按重量计占第一层的约25％到约50％。第一组分是第一聚烯烃，选自聚丙烯和聚丙烯共聚物。第二组分是第二聚烯烃，其存在的量按重量计占第一层的约0％到约50％。第二聚烯烃选自乙烯共聚物、超低密度聚乙烯、聚丁烯、聚丁二烯和丁烯乙烯共聚物。第三组分存在的量按重量计为第一层的约0％到约40％，是一种射频(“RF”)敏感聚合物。这种RF聚合物选自聚酰胺、乙烯丙烯酸共聚物、乙烯甲基丙烯酸共聚物、聚酰亚胺、聚氨酯、聚酯、聚脲、乙烯乙酸乙烯酯共聚物(其乙酸乙烯酯共聚单体的含量按重量计占共聚物的12％-50％)、乙烯丙烯酸甲酯共聚物(其丙烯酸甲酯共聚单体的含量按重量计占共聚物的12％-40％)、乙烯乙烯醇(其乙烯醇共聚单体的含量按摩尔百分比计占共聚物的12％-70％)。第四组分存在的量占约0％到约40％，它是第一热塑弹性体。
端口管的第二层共轴心配置在第一层内。在本发明的一个优选方式中，这一层是对溶剂粘结敏感的聚合材料，更优选的是含有第二热塑弹性体。任选，第二层可以包含按重量计占约0％到约20％的添加剂聚丙烯、高密度聚乙烯、二氧化硅、增滑剂、脂肪酰胺、阿克蜡(acrawax)及其它类似物质。
膜管有外层、中间层和内层。膜管的外层能够被溶剂粘结到端口管的第二层。本发明的优选实施方式中，膜管的外层(A)是(1)按重量计占外层约0％到约60％的第一聚烯烃和(2)按重量计占外层约40％到约100％的第一热塑弹性体第二组分的共混聚合物。中间层(B)粘附到外层上。在本发明优选的实施方式中，中间层是(1)按重量计占中间层约35％到约100％的第二热塑弹性体和(2)按重量计占中间层约0％到约65％的第二聚烯烃的共混聚合物。
膜管的内层在与外层相反一侧粘附到中间层上。内层是含多组分的共混聚合物，一种优选的方式中含有(1)按重量计占内层约25％到约55％的第三聚烯烃；(2)按重量计占内层约0％到约50％的第四聚烯烃，其选自乙烯共聚物、超低密度的聚乙烯、聚丁烯和丁烯乙烯共聚物；(3)按重量计占内层约0％到约40％的射频敏感聚合物，其选自聚酰胺、乙烯丙烯酸共聚物、乙烯甲基丙烯酸共聚物、聚酰亚胺、聚氨酯、聚酯、聚脲、乙烯乙酸乙烯酯共聚物(其乙酸乙烯酯共聚单体的含量按重量计占共聚物的12％-50％)、乙烯丙烯酸甲酯共聚物(其丙烯酸甲酯共聚单体的含量按重量计占共聚物的12％-40％)、乙烯乙烯醇(其乙烯醇共聚单体的含量按摩尔百分比占共聚物的12％-70％)；和(4)按重量计占内层的约0％到约40％的第三热塑弹性体。
本发明的这些及其它方面和特性将根据下面的附图和说明书进行讨论。
附图的简单描述
图1是带有端口密封件组件的可流动物质容器俯视图。
图2是本发明端口管的剖面图。
本发明的详细描述
本发明允许有多种不同的实施方式。公开了本发明优选的实施方式，要知道本公开仅看作为本发明原理的实施范例，而无意将本发明的众多方面限制到所例举的实施方式中。
图1展示了可流动物质容器10，它的侧壁12沿着外围边缘被密封，在中间形成了器室14。端口管密封件组件16为容器内物质提供了通路。容器10优选是由不含PVC的材料制备。在本发明的一个优选方式中，侧壁12由多种组分的聚合物合金如美国专利No.5,686,527中详细公布的物质构成，此专利引入本文作为参考并作为本发明的一部分。一种特别适合的聚合物合金是聚丙烯、超低密度聚乙烯、聚酰胺及苯乙烯和烃类嵌段共聚物的共混物。图1所示容器10特别适用于医疗应用，仅举几例，如存储和输送I.V.液、腹膜透析液、医疗药物、血液及血液组分。这种容器还可以考虑用于储存食品，用作腹膜透析的排放袋或储存其它消费品。
“可流动物质”的意思是可以靠重力流动的物质。因此可流动物质既包括液体物质，也包括粉末和颗粒物质和其它类似物质。
图2展示的是端口管组件16。端口管组件16包括端口管18和在其内共轴心配置的膜管20。膜管20的流体通道22被位于膜管20的中部的膜23密封。对于医疗应用，膜23能够被输液器的针尖刺破，使容器内物质处于与例如所治病人的血管系统流体连通的状态。
在本发明的一种优选方式中，端口管18具有多层结构，更优选具有第一层22和第二层24。第一层22应该由不含PVC的材料构成，该材料能够被密封到容器10的侧壁12上，优选是采用射频热合技术进行密封。在该发明的一个优选方式中，第一层22是如下物质形成的共混聚合物：(a)按重量计占第一层约25％到约50％，更优选是占约30％到约40％的第一聚烯烃，其选自聚丙烯及聚丙烯的共聚物；(b)按重量计占第一层约0％到约50％，更优选是占约5％到约40％的第二聚烯烃，为含α-烯烃的聚合物或共聚物，更优选是乙烯和α-烯烃的共聚物；(c)按重量计占第一层约0％到约40％，更优选是占约10％到约40％的射频敏感聚合物，其选自聚酰胺、乙烯丙烯酸共聚物、乙烯甲基丙烯酸共聚物、聚酰亚胺、聚氨酯、聚酯、聚脲、乙烯乙酸乙烯酯共聚物(其乙酸乙烯酯共聚单体的含量按重量计占共聚物的12％-50％)、乙烯丙烯酸甲酯共聚物(其丙烯酸甲酯共聚单体的含量按重量计占共聚物的12％-40％)、乙烯乙烯醇(其乙烯醇共聚单体的含量按摩尔百分比计占共聚物的12％-70％)；和(d)按重量计占第一层约0％到约40％，更优选是占约10％到约40％的热塑弹性体。
端口管18的第二层24由不含PVC的材料构成，它能够被溶剂粘合到膜管20上。本发明的一种优选方式中，第二层24是热塑弹性体，或按重量计占第二层约80％到约100％的热塑弹性体与约0％到约20％含丙烯聚合物的共混物。最好第二层24在高压灭菌温度下会轻微变软，使得端口管和膜管组件在蒸汽灭菌时，端口管会更加牢固地粘附到膜管上，但这是任选的。
如图所示，第一层的厚度要大于第二层。在本发明的一种优选方式中，第一层的厚度约0.381毫米(密耳)到约1.016毫米(密耳)，更优选是在约0.508毫米(密耳)到约0.762毫米(密耳)。第二层的厚度约0.0508毫米(密耳)到约0.254毫米(密耳)，更优选是在约0.0762毫米(密耳)到约0.1778毫米(密耳)。
膜管20应由不含PVC的材料制备，能够被粘结到端口管18上，更优选是采用溶剂粘结技术进行粘结。溶剂粘结在本领域中众所周知。溶剂粘结通常包括对聚合材料施加溶剂以使聚合物部分溶解。在溶解状态下，溶解的聚合材料与该聚合材料想要粘结的材料接触，如另外一种聚合物。本发明中用于材料溶剂粘结的合适的溶剂至少包括下面芳香族溶剂：环己烷、环己酮、甲苯、四氢呋喃、异丙苯、二甲苯、二乙苯、萘烷、四氢化萘和戊基苯，仅举几个例子。
因此，为了将膜管溶剂粘结到端口管上，使膜管欲与端口管接触的部分接触到溶剂，通常是通过将膜管相应部分浸渍到溶剂中。然后将膜管以可伸缩的方式插入到膜管中，在此形成强的粘结。
在本发明的一个优选方式中，膜管20是多层结构，有外层30、中间层32和内层34。在本发明的一个优选方式中，外层30是下述物质形成的共混聚合物：(a)占外层约0重量％到约60重量％，更优选是占约20重量％到约55重量％，最优选是占约30重量％到约50重量％的聚烯烃和(b)占外层约40重量％到约100重量％，更优选是占约45重量％到约80重量％，最优选是占约50重量％到约70重量％的热塑弹性体。
同样，在本发明的一个优选方式中，中间层32是下述物质形成的共混聚合物：(a)占中间层约35重量％到约100重量％，更优选是占约50重量％到约90％重量，最优选是占约70重量％至约90重量％的热塑弹性体和(b)占中间层约0重量％至约65重量％，更优选是占约10重量％至约50重量％，最优选是占约10重量％到约30重量％的聚烯烃。
同样，在本发明的一个优选方式中，内层34是以下物质形成的共混聚合物：(a)占内层约25重量％至约55重量％，更优选是占约25重量％至约40重量％的聚烯烃；(b)占内层约0重量％至约50重量％，更优选是占约0重量％到约40重量％，最优选是占约0重量％至约20重量％的聚烯烃，其选自含α-烯烃的聚合物或共聚物，更优选是乙烯和α-烯烃的共聚物；(c)占内层约重量0％至约40重量％，更优选是占约重量15％至约40重量％的射频敏感聚合物，其选自聚酰胺、乙烯丙烯酸共聚物、乙烯甲基丙烯酸共聚物、聚酰亚胺、聚氨酯、聚酯、聚脲、乙烯乙酸乙烯酯共聚物(其乙酸乙烯酯共聚单体的含量按重量计占共聚物的12％-50％)、乙烯丙烯酸甲酯共聚物(其丙烯酸甲酯共聚单体的含量按重量计占共聚物的12％-40％)、乙烯乙烯醇(其乙烯醇共聚单体的含量按摩尔百分比计占共聚物的12％-70％)；和(d)按重量计占内层约0％到约40％，更优选是占约15％至约40％的热塑弹性体。
在本发明的一种优选方式中，外层30的厚度约0.0762毫米(密耳)至约0.381毫米(密耳)，更优选是约0.0762毫米(密耳)至约0.254毫米(密耳)。中间层32的厚度约0.254毫米(密耳)至约0.889毫米(密耳)，更优选是约0.254毫米(密耳)至约0.762毫米(密耳)。内层34的厚度在约0.0762毫米(密耳)到约0.381毫米(密耳)，更优选是在约0.127毫米(密耳)至约0.254毫米(密耳)。
热塑弹性体包括苯乙烯和烃类的共聚物、EPDM和二元乙丙橡胶。苯乙烯可以是取代或未被取代的苯乙烯。苯乙烯和烃类的共聚物可以是嵌段共聚物，包括二嵌段、三嵌段和星形嵌段。也可以是无规共聚物和本领域技术人员所熟知的其它类型的苯乙烯和烃类的共聚物。因此，苯乙烯和烃类的共聚物包括但不限于如苯乙烯-丁烯-苯乙烯嵌段共聚物、苯乙烯-乙烯-丁烯-苯乙烯嵌段共聚物、苯乙烯-异丁烯-苯乙烯及本领域中所熟知的大量其它类型的苯乙烯和烃类的共聚物。苯乙烯和烃类的共聚物还包括上面所确定的不同类型的苯乙烯和烃类共聚物的共混物。
苯乙烯和烃类的共聚物可以改性或加上羧基、羧酸酐、羧酸酯、环氧基和一氧化碳官能团。在本发明的一个优选方式中，端口管18的第一层22和膜管20的内层34的热塑弹性体为SEBS共聚物，所述共聚物按重量计其马来酸酐基团含量约2％或小于2％。这种共聚物在Shell Chemical Company有售，商品名为KRATONFG1924X和FG1901X。
端口管18的第二层24和膜管20的外层30中的热塑弹性体优选是苯乙烯和二烯类共聚物，更优选是选自苯乙烯-乙烯-丁烯-苯乙烯共聚物和苯乙烯-异戊二烯-苯乙烯共聚物。第二层热塑弹性体更优选是乙烯丁烯共聚物和苯乙烯-乙烯-丁烯-苯乙烯共聚物。已经发现这种共聚物很适合溶剂粘结。合适的SEBS共聚物在Shell Chemical Company有售，商品名为KRATONKG1657。
膜管中间层的热塑弹性体是三嵌段含量高的SEBS共聚物。合适的聚合物在Shell Chemical Company有售，商品名为KRATONKG1660、KG1652和KG1650。
本发明的适宜的聚烯烃包括含2-17个碳的α-烯烃的均聚物和共聚物。适宜的聚丙烯聚合物包括均聚物和共聚物。适宜的共聚单体是含有2至17个碳的α-烯烃，最优选是乙烯，其量按重量计占共聚物约1％至约8％。
适宜的含α-烯烃聚合物包括含有2至7个碳的α-烯烃的均聚物、共聚物和互聚物。端口管18的第一层22和膜管20的内层34中，适宜的乙烯α-烯烃共聚物的密度由ASTM D-792测定应小于约0.915g/cm3(g/cc)，更优选是小于约0.905g/cm3(g/cc)，通常被称为极低密度聚乙烯(VLDPE)、超低密度聚乙烯(ULDPE)和类似其它叫法。在本发明的一个优选方式中，乙烯和α-烯烃共聚物是采用单点催化剂如茂金属催化剂、钒催化剂和其它类似催化剂得到的。其它合适的催化剂系统在美国专利No.5,783,638和5,272,236中有公布。合适的乙烯和α-烯烃共聚物包括Dow Chemical Company以AFFINITY商品名、Dupont-Dow以ENGAGE商品名、Exxon以EXACT商品名和PhillipsChemical Company以MARLEX商品名出售的那些产品。
适宜的聚酰胺选自：由碳数范围为2-13的二胺经缩合反应生成的脂肪族聚酰胺、由碳数范围为2-13的二酸经缩合反应生成的脂肪族聚酰胺、由二聚脂肪酸经缩合反应生成的聚酰胺和含酰胺的共聚物。
在本发明的一个优选方式中，端口管组件要满足如下物理特性：(1)针头插入的力要平均小于约155.75N(lbs)，(2)针头撤出的力平均要大于约22.25N(lbs)。将膜管从端口管分离的拉力要大于针头撤出的力。
下面为本发明的一个非限制性的实施例。
实施例：
具有内层和外层的两层端口管由共挤塑形成。内层的厚度为0.01524厘米(英寸)，由SEBS制备。外层的厚度为0.06604厘米(英寸)，由共混聚合物制备，所述共混物为按重量计占外层35％聚丙烯/5％超低密度聚乙烯/30％二聚脂肪酸多酰胺/30％带马来酸酐官能团的SEBS。
具有内层、中间层和外层的三层膜管由共挤塑形成。内层是共混聚合物，按重量计为30％聚丙烯/35％二聚脂肪酸多酰胺/35％SEBS。中间层是85％SEBS和15％聚丙烯的共混物。外层是45％SEBS和55％聚丙烯。内层厚度是0.00762厘米(英寸)，中间层0.05842厘米(英寸)，外层是0.01524厘米(英寸)。
聚合物片材由含按重量计10％二聚脂肪酸多酰胺、35％超低密度的聚乙烯、45％聚丙烯和10％带马来酸酐官能团的SEBS的共混物挤塑形成。
将两张聚合片材的长方形板片重合到一起，并沿3个周边将其密封形成一个囊腔。将端口管管段插入到囊腔的开口端，在对最后的周边密封时将该管段热密封到此处，形成容器。将膜管管段浸渍于环己酮中，然后以可伸缩方式插入到所述端口管管段。
将容器固定在一机械检测器附近。端口管与固定在机械检测器十字头上的针头相连。检测器十字头的速度设置为0.85cm/sec(in/min)。十字头的设定要使针头在端口管内达到所期望插入深度。使用该检测器测定针头插入力和针头拔出力。50次实验后平均针头插入值为59.23N(lbf)。50次实验的平均针头拔出力为46.15N(lbf)。这些测定是在针头在膜管停留24小时后进行的。
还采用该检测器对从容器中去除端口管或以其它方式破坏容器或端口管所需的拉力进行了测定。端口管插入到固定有容器的检测器上。28次试验平均拉力为133.68N(lbf)。该测定是在对容器进行蒸汽灭菌前进行。容器经过蒸汽灭菌后，30次试验的值为1 89.93N(lbf)。
根据上面所述，可能产生许多变化和改进的形式，这并没有脱离本发明的核心和范围。但应该明确，无意将本发明的范围限制为此处说明的特定装置，也不应由此推断出对本发明的限制。当然，所附权利要求意图覆盖所有这些落在权利要求范围内的改进。

Claims (40)

1.多层的不含PVC的管子，它包括：
第一层，它是以下物质形成的共混聚合物：(a)按重量计占第一层25％至50％的第一聚烯烃，所述聚烯烃选自聚丙烯和聚丙烯共聚物，(b)按重量计占第一层1％至50％的第二聚烯烃，所述聚烯烃选自乙烯共聚物、聚丁烯、聚丁二烯和；(c)按重量计占第一层1％到40％的射频敏感聚合物，其选自聚酰胺、乙烯丙烯酸共聚物、乙烯甲基丙烯酸共聚物、聚酰亚胺、聚氨酯、聚酯、聚脲、其乙酸乙烯酯共聚单体含量按重量计占共聚物12％-50％的乙烯乙酸乙烯酯共聚物、其丙烯酸甲酯共聚单体含量按重量计占共聚物12％-40％的乙烯丙烯酸甲酯共聚物、其乙烯醇共聚单体含量按摩尔百分比计占共聚物12％-70％的乙烯乙烯醇；(d)占1％至40％的第一热塑弹性体；和
在第一层内共轴心配置的第二层，它是仅由苯乙烯和二烯类共聚物组成的第二热塑弹性体。
2.权利要求1中的管子，其中聚酰胺选自：由碳数范围为2-13的二胺经缩合反应生成的脂肪族聚酰胺、由碳数范围为2-13的二酸经缩合反应生成的脂肪族聚酰胺、由二聚脂肪酸经缩合反应生成的聚酰胺和含酰胺的共聚物。
3.权利要求1的管子，其中聚酰胺是二聚脂肪酸多酰胺。
4.权利要求1的管子，其中第一聚烯烃是丙烯与选自含2-17个碳的α-烯烃的单体形成的共聚物。
5.权利要求4的管子，其中第一聚烯烃是丙烯和乙烯的共聚物，其乙烯含量按重量计占第一聚烯烃的1％到8％。
6.权利要求1的管子，其中第一热塑弹性体选自第一苯乙烯和烃类的共聚物。
7.权利要求6的管子，其中第一苯乙烯和烃类的共聚物选自具有二嵌段、三嵌段、辐射形嵌段和星形嵌段结构的聚合物。
8.权利要求7的管子，其中第一热塑弹性体是苯乙烯-乙烯-丁烯-苯乙烯嵌段共聚物。
9.权利要求7的管子，其中第一热塑弹性体带有官能团，所述官能团选自羧酸、羧酸酯、羧酸酐、环氧化物和一氧化碳。
10.权利要求9的管子，其中第一热塑弹性体带马来酸酐官能团。
11.权利要求1的管子，其中苯乙烯和二烯类共聚物是苯乙烯和烃类的共聚物。
12.权利要求11的管子，其中苯乙烯和烃类的共聚物选自具有二嵌段、三嵌段、辐射形嵌段和星形嵌段结构的聚合物。
13.权利要求11的管子，其中苯乙烯和烃类的共聚物选自苯乙烯-乙烯-丁烯-苯乙烯共聚物、苯乙烯-异戊二烯-苯乙烯共聚物和苯乙烯-乙烯-丙烯-苯乙烯共聚物。
14.权利要求11的管子，其中苯乙烯和烃类的共聚物选自苯乙烯-乙烯-丁烯-苯乙烯二嵌段共聚物和苯乙烯-乙烯-丁烯-苯乙烯三嵌段共聚物。
15.权利要求1的管子，其中第二聚烯烃是乙烯与选自α-烯烃的单体形成的共聚物。
16.权利要求15的管子，其中乙烯和α-烯烃的共聚物通过采用单点催化剂获得。
17.权利要求1的管子，其中第二层还包含添加剂，其选自高密度聚乙烯、二氧化硅、增滑剂、脂肪酰胺和阿克蜡。
18.权利要求17的管子，其中添加剂的含量按重量计占第二层0％到20％。
19.多层的不含PVC的管子，它包括：
外层，它由以下物质形成：(a)按重量计占外层0％到60％的第一聚烯烃和(b)按重量计占外层40％到100％的第一热塑弹性体；
粘附到外层上的中间层，它是以下物质形成的共混聚合物：(a)按重量计占中间层35％到100％的第二热塑弹性体和(b)按重量计占中间层0％到65％的第二聚烯烃；和
在外层相反一侧粘附到中间层上的内层，它是以下物质的共混聚合物(a)按重量计占内层25％到55％的第三聚烯烃，(b)按重量计占内层0％到50％的第四聚烯烃，其选自乙烯共聚物、聚丁烯；(c)按重量计占内层0％到40％的射频敏感聚合物，其选自聚酰胺、乙烯丙烯酸共聚物、乙烯甲基丙烯酸共聚物、聚酰亚胺、聚氨酯、聚酯、聚脲、其乙酸乙烯酯共聚单体含量按重量计占共聚物12％-50％的乙烯乙酸乙烯酯共聚物、其丙烯酸甲酯共聚单体含量按重量计占共聚物12％-40％的乙烯丙烯酸甲酯共聚物、其乙烯醇共聚单体含量按摩尔百分比计占共聚物12％-70％的乙烯乙烯醇；和(d)按重量计占内层0％到40％的第三热塑弹性体。
20.权利要求19的管子，其中聚酰胺选自：由碳数范围为2-13的二胺经缩合反应生成的脂肪族聚酰胺、由碳数范围为2-13的二酸经缩合反应形成的脂肪族聚酰胺、由二聚脂肪酸经缩合反应形成的聚酰胺和含酰胺的共聚物。
21.权利要求19的管子，其中聚酰胺是二聚脂肪酸多酰胺。
22.权利要求19的管子，其中第一聚烯烃选自聚丙烯均聚物、丙烯与选自含2-17个碳的α-烯烃的单体形成的共聚物、乙烯均聚物和乙烯与选自含2-17个碳的α-烯烃的单体形成的共聚物。
23.权利要求22的管子，其中第一聚烯烃是聚丙烯和乙烯共聚物，其中乙烯按重量计占第一聚烯烃的1％到8％。
24.权利要求19的管子，其中第二聚烯烃选自聚丙烯均聚物、丙烯与选自含2-17个碳的α-烯烃的单体形成的共聚物、乙烯均聚物和乙烯与选自含2-17个碳的α-烯烃的单体形成的共聚物。
25.权利要求19的管子，其中第三聚烯烃选自聚丙烯均聚物、丙烯与选自含2-17个碳的α-烯烃的单体形成的共聚物、乙烯均聚物和乙烯与选自含2-17个碳的α-烯烃的单体形成的共聚物。
26.权利要求19的管子，其中第一热塑弹性体选自第一苯乙烯和烃类的共聚物。
27.权利要求26的管子，其中第一苯乙烯和烃类的共聚物选自具有二嵌段、三嵌段、辐射形嵌段和星形嵌段结构的聚合物。
28.权利要求27的管子，其中第一热塑弹性体选自第一苯乙烯-乙烯-丁烯-苯乙烯共聚物、苯乙烯-异戊二烯-苯乙烯共聚物和苯乙烯-乙烯-丙烯-苯乙烯共聚物。
29.权利要求28的管子，其中第一热塑弹性体是苯乙烯-乙烯-丁烯-苯乙烯二嵌段共聚物和苯乙烯-乙烯-丁烯-苯乙烯三嵌段共聚物。
30.权利要求19的管子，其中第二热塑弹性体选自第二苯乙烯和烃类共聚物。
31.权利要求30的管子，其中第二苯乙烯和烃类共聚物选自带二嵌段结构、三嵌段结构的聚合物、共聚物、苯乙烯和烃类的星形嵌段共聚物和包含上述物质的共混物。
32.权利要求31的管子，其中第二热塑弹性体选自第二苯乙烯-乙烯-丁烯-苯乙烯共聚物、第二苯乙烯-异戊二烯-苯乙烯共聚物和第二苯乙烯-乙烯-丙烯-苯乙烯共聚物。
33.权利要求19的管子，其中第三热塑弹性体选自第三苯乙烯和烃类共聚物。
34.权利要求33的管子，其中第三苯乙烯和烃类的共聚物选自带二嵌段结构、三嵌段结构的聚合物、星形嵌段共聚物和包含上述物质的共混物。
35.权利要求34的管子，其中第三热塑弹性体是第三苯乙烯-乙烯-丁烯-苯乙烯嵌段共聚物。
36.权利要求34的管子，其中第三热塑弹性体带有官能团，所述官能团选自羧酸、羧酸酯、羧酸酐、环氧化物和一氧化碳。
37.权利要求36的管子，其中第三热塑弹性体带有马来酸酐官能团。
38.权利要求19的管子，其中第四聚烯烃是乙烯与选自α-烯烃的单体形成的共聚物。
39.权利要求38的管子，其中第四聚烯烃是乙烯与α-烯烃的共聚物。
40.权利要求39的管子，其中乙烯和α-烯烃的共聚物通过使用单点催化剂获得。
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