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CN103533969A - 高阻隔性弹性体粪便导管或造口袋 - Google Patents

高阻隔性弹性体粪便导管或造口袋 Download PDF

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CN103533969A
CN103533969A CN201280021995.9A CN201280021995A CN103533969A CN 103533969 A CN103533969 A CN 103533969A CN 201280021995 A CN201280021995 A CN 201280021995A CN 103533969 A CN103533969 A CN 103533969A
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conduit
feces
elastomer
stink
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M.L.蔡
T.阮-德玛丽
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Convatec Technologies Inc
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Abstract

粪便导管或造口袋，由臭味阻隔性材料制成，包括热塑性弹性体、臭味阻隔性改良剂和防粘连剂。

Description

高阻隔性弹性体粪便导管或造口袋
技术领域
本发明涉及用于粪便导管、粪便袋或造口袋的臭味阻隔性材料。
背景技术
粪便导管有时候由于粪便臭味透过管壁而遭受诟病。
臭味阻隔性差的可能原因是这些器件由硅酮材料组成。硅酮的臭味阻隔性已知在聚合物材料中是最差的之一。例如，硅酮的氧透过率据报道是775,000 cc mil/m2/天。因此，20 mil厚的硅酮导管比通常使用的透过率为50cc mil/m2/天或更低的造口薄膜差大约3个数量级。
对于硅酮粪便导管具有不好的臭味阻隔性的另一可能的解释是该类器件中使用的挤出硅酮相对粗糙并因此会存蓄粪便组分。存蓄了粪便的斑点轮廓提供了相当大的表面积，臭味通过该面积进行传递。
高的臭味透过率和大的表面积结合成为了粪便导管中使用的硅酮臭味阻隔特性不好的原因之一。
希望的是开发一种用于粪便导管中的材料，该材料具有所需的硅酮特性同时提供了显著优于硅酮的臭味阻隔性。
本发明的目的是提供具有这些特性的臭味阻隔性聚合物。
发明内容
热塑性弹性体(TPE)或可固化的弹性体在医疗器件中的应用是众所周知的。然而，这些弹性体不为人知的是显示高的臭味阻隔性能。本发明是改性弹性体以实现高的臭味阻隔性同时保持其柔软性、后挤出转化(焊接和粘结)的能力以及不粘连的特征。
本发明的一个实施方案涉及由高阻隔性弹性体制成的单层导管，从而根据ASTM D3985通过氧透过率而测量的臭味阻隔性在23℃不大于50,000 cc mil/m2/天，或更优选不大于 5,000 cc mil/m2/天。这样的导管在臭味阻隔性上比硅酮导管好至少10倍。
U.S.专利No. 6,946,522、7,056,971和7,060,753公开了使用液体聚异丁烯油增塑剂提高TPE的气体阻隔性。然而，这些配制剂，尤其是当目的在于软质弹性体(即肖氏A小于60)时，产生粘连问题，其中TPE导管的表面在折叠和包装时相互密封。使用更大量的油增塑剂允许产生更软的TPE，但是伴随着在油性表面中的不利效应，导致后挤出转化(焊接和粘结)不好。另外，没有公开基于烯烃嵌段共聚物(OBC，如Dow公司制备的InfuseTM)的TPE。 尽管存在使粘连最小化的普通方法，包括添加矿物油或滑润添加剂。然而，这些方法具有的缺点在于由于它们对于表面粘结的不利效应所以阻止了各部分进一步转化成粪便导管。U.S.专利No. 7,629,406公开了以小于4%的浓度使用有机粘土以提高高密度聚乙烯(HDPE)的阻隔性能。然而，没有提到在TPE中使用有机粘土，其中肖氏A硬度不大于60，或者优选不大于50。
本发明的另一实施方案涉及一种粪便导管，其肖氏A硬度不大于60和氧透过率不大于2,500 cc/m2/天或优选不大于1,000 cc/m2/天，包含(1)热塑性弹性体、(2)臭味阻隔性改良剂和(3)至少0.1%的防粘连剂，其中热塑性弹性体选自苯乙烯嵌段共聚物、热塑性硫化橡胶或聚烯烃弹性体，并且其中臭味阻隔性改良剂选自聚异丁烯、聚丁烯或有机粘土，而其中防粘连剂主要选自无机填料，如硅石、滑石、粘土、云母等以及它们的共混物。要注意的是在一个实施方案中有机粘土既可以用作臭味阻隔性改良剂又可以用作防粘连剂。有机粘土包括蒙脱石粘土、蒙皂石粘土、嵌入粘土（intercalated clay）、纳米粘土或上述粘土的混合物。本发明中描述的有机粘土包括Nanocor公司制造的蒙脱石粘土，这是蒙皂石粘土族中最普通的一种。有机粘土可以由具有独特形态的纳米粘土组成，由此一维是在纳米范围内。另外，有机粘土优选使用有机嵌入物嵌入从而形成粘土-化学品络合物，其中粘土通道间隔由于表面改性过程而增加。在适当的温度和剪切条件下，嵌入体能够在树脂基质中脱落。任选地，可以使用下面的添加剂以便于导管挤出物的制造，包括熔体粘度改性剂、增粘剂、防粘剂、增塑剂等。
基于热塑性弹性体的苯乙烯嵌段共聚物(SBC)包括苯乙烯-异戊二烯-苯乙烯(SIS)、苯乙烯-丁二烯-苯乙烯(SBS)、苯乙烯-乙烯/丁烯-苯乙烯(SEBS)、苯乙烯-乙烯/丙烯-苯乙烯(SEPS)和它们的共混物。热塑性硫化橡胶 (TPV)包括可固化橡胶和聚烯烃(即PP或PE的均聚物和共聚物)的共混物。可固化橡胶包括 EPDM、EP橡胶、山都平（santoprene）等。聚烯烃弹性体包括烯烃嵌段共聚物(OBC)，如Dow公司制备的Infuse，其中在相同的聚合物基质中烯烃嵌段共聚物的晶相充当硬嵌段，而无定形嵌段共聚物充当软嵌段。下面是根据ASTM D3985由在23℃的氧透过率测量的臭味阻隔性的概述：
表1-不含有机粘土或沸石的各种弹性体的臭味阻隔性比较
  硅酮 SBC TPV OBC SBC w/聚异丁烯 SBC w/聚异丁烯和有机粘土
OTR，cc/m2/天，20mil 壁厚，ASTM D3985 37,500 2,500-4,500 2,500 2,500 1,000 250
洋葱阻隔性，ISO 8670-3 非常差，在10分钟可检测 差，在60分钟可检测 差，在60分钟可检测 差，在60分钟可检测 较好，在120分钟可检测 好，持续8小时不可检测
当向含有SBC热塑性弹性体和液体聚异丁烯的高阻隔性弹性体配制剂加入至少0.1%或更优选大于0.5%的防粘连剂时，对于制造不粘连的粪便导管实现了大约1000cc/m2/天范围的臭味阻隔性。这种程度的臭味阻隔性提高由根据ISO 8670-3的洋葱测试得以确认，这时洋葱气味透出时间超过120分钟。另外的阻隔性提高在由含SBC热塑性弹性体、液体聚异丁烯、有机粘土的PTE制造的粪便导管中可见。在此实例中，洋葱气味透出时间超过8小时。氧阻隔性和洋葱阻隔性的结果都示于表1中。
本发明的另一实施方案是基于多层结构的粪便导管，其中至少一层选自不含任何防粘连剂的上述高阻隔性弹性体，和至少另一表皮层选自(1)具有至少0.1%的防粘连剂的上述相同的高阻隔性弹性体，或使用或不使用防粘连剂的弹性体合金。弹性体合金定义为在分子水平上不相容的两种聚合物基质的共混物。防粘连剂的优点是施加粗糙的表面使得导管不粘连。弹性体合金的优点在于分子水平的不相容性在导管表面产生粗糙度，产生不粘连的导管。另外，添加用于弹性体合金的普通材料包括但不限于热塑性聚氨酯(TPU)。由于TPU中极性更强的结构，随后的弹性体合金转化更容易。因为导管结构的大部分由高阻隔性弹性体提供，所以臭味阻隔性和柔软性基于上面的公开内容得以保持。因为中心层和表皮层都是基于弹性体，所以粪便导管各层之间的粘合足够好。
除了添加防粘连剂之外，还可以采用冷加工条件以增强导管壁的粗糙表面使得导管不粘连。防粘连剂和/或冷加工条件的作用是产生粗糙的表面，该表面可以通过用非接触的表面结构分析仪如扫描型白光干涉仪(Scanning White Light interferomtry)(SWLI)、原子力显微镜(AFM)等表征表面粗糙度。基于SWLI的非接触成像表面结构分析仪由Zygo NewView 7300制造。非接触的原子力显微镜可以由FEI公司制造。已经用来定量表面形貌质量的典型参数是表面粗糙度，其用算术平均值Ra表示。在本发明的公开内容中，当在使用或不使用冷加工温度的情况下使用防粘连剂时，Ra不小于0.1μm或优选不小于1μm的粗糙表面产生不粘连的粪便导管。
关于本发明中描述的配制剂的重要特征是其通过焊接和粘合剂粘结的后挤出转化的能力。达到了大于5N/in的粘合强度和热焊接强度。
本发明的另一实施方案涉及使用有机粘土和/或沸石提高弹性体导管的臭味阻隔性。例如，单层导管可以由含有机粘土的弹性体制造，所述含有机粘土的弹性体选自硅酮、聚氨酯、苯乙烯嵌段共聚物、热塑性硫化橡胶或聚烯烃弹性体，其中肖氏A硬度不大约60或更优选不大于50。
使用纳米复合材料(纳米粘土)填料提高臭味阻隔性并非新的。添加纳米复合材料填料产生对于引起臭味的化合物的弯曲路径；由此提高了基材的臭味阻隔性。有各公司如Nanocor、Nanoresin、Southern Clays、Nano-X、Inmat等销售的含有涂料、添加剂或聚合物的各种纳米复合材料。因为纳米复合材料大多是基于粘土的，所以是相对刚性的。因此，在FMS应用中使用纳米复合材料填料的挑战是双重的，(1)将纳米复合材料填料或涂料润湿和粘附在硅酮管上的困难，和(2)弯曲时的臭味阻隔性能。因此，本发明的独特性是用含完全覆盖的和/或相对均匀地分散的纳米复合材料的导管配制软管，所述软管在弯曲时不开裂。这种含纳米粘土的柔软导管特征在于肖氏A硬度不大于60或更优选不大于50。
本发明的另一实施方案涉及由含沸石的弹性体制造的单层导管，所述含沸石的弹性体选自硅酮、聚氨酯、苯乙烯嵌段共聚物、热塑性硫化橡胶或聚烯烃弹性体，其中肖氏A硬度不大于60或更优选不大于50。
添加沸石产生弯曲的路径和位置以吸附引起臭味的化合物；由此提高基材的臭味阻隔性。有各公司销售的各种沸石，如UOP。因为沸石是硬质填料，所以使用时它们产生刚性。因此，在FMS应用中使用沸石的挑战是双重的，(1)将沸石涂料润湿和粘附在硅酮管上的困难，和(2)弯曲时的臭味阻隔性能。因此，本发明的独特性是用相对均匀地含沸石的弹性体导管配制软管，所述软管在弯曲时不开裂。这种含沸石的柔软导管特征在于肖氏A硬度不大于60或更优选不大于50。
本发明的另一实施方案涉及施加到弹性体基材上的含有机粘土的涂料，所述弹性体基材选自硅酮、聚氨酯、苯乙烯嵌段共聚物、热塑性硫化橡胶或聚烯烃弹性体，其中肖氏A硬度不大于60或更优选不大于50。
本发明的另一实施方案涉及施加到弹性体基材上的含沸石的涂料，所述弹性体基材选自硅酮、聚氨酯、苯乙烯嵌段共聚物、热塑性硫化橡胶或聚烯烃弹性体，其中肖氏A硬度不大于60或更优选不大于50。
如下面所述进行系列实验。对总计4种不同的纳米复合材料进行评价，两种来自Southern Clay公司，两种来自Nanocor公司。使用两种类型的涂覆基质，硅酮和聚氨酯。下面是对这些发现的概述。
实施例#1：由纳米复合材料组成的硅酮涂料：
将2.5%的下述纳米复合材料加入到双组分的由Nusil 6350制成的硅酮中，包括
(1) Southern Clay Cloisite Na+，水合硅酸铝，
(2) Southern Clay Cloisite 15A，含有膨润土的铵盐，
(3) Nanocor 1.30E (十八烷基铵表面相容的蒙脱石)，和
(4) Nanocor 1.34 TCN (甲基、双羟乙基十八烷基铵表面相容的蒙脱石)。
将所述双组分硅酮作为涂料施加到硅酮导管上，然后在130℃加热固化30分钟。然后将涂覆的导管根据ISO 8670-3:2000测试洋葱气味阻隔性。将大约5g洋葱剁碎并装进12cm长的涂覆的硅酮管(即导管)中。  
纳米复合材料 没有 Cloiste NA+ Cloiste 15A Nanocor 1.30E Nanocor 1.34TCN
涂覆基质     Nusil 6350 硅酮 硅酮 硅酮 硅酮 硅酮
基材，Dow Corning C6-135 硅酮 硅酮 硅酮 硅酮 硅酮
洋葱气味开始出现 5分钟 45分钟 45分钟 90分钟 60分钟
可以看出，在硅酮涂料中添加2.5%的纳米复合材料提高了硅酮管中的洋葱气味阻隔性。带有硅酮涂料的对比试验在大约5分钟时在封闭的硅酮管外部开始出现洋葱气味。这与没有任何涂料的硅酮管大致相同。在将含有2.5%的纳米复合材料的硅酮涂料施涂到硅酮管上之后，洋葱气味的出现延长到45-90分钟。
实施例#2：由纳米复合材料组成的聚氨酯涂料，无底漆：
将2.5%的下述纳米复合材料添加到双组分的由Smooth-On，Vytaflex 30制成的聚氨酯中，包括
(1)Southern Clay Cloisite Na+，水合硅酸铝，
(2) Southern Clay Cloisite 15A，含有膨润土的铵盐，
(3) Nanocor 1.30E (十八烷基铵表面相容的蒙脱石)，和
(4) Nanocor 1.34TCN (甲基、双羟乙基十八烷基铵表面相容的蒙脱石)。
将所述双组分聚氨酯作为涂料施加到硅酮导管上，然后室温固化6小时。然后将涂覆的导管根据ISO 8670-3:2000测试洋葱气味阻隔性。将大约5g洋葱剁碎并装进12cm长的涂覆的硅酮管(即导管)中。  
纳米复合材料 没有 Cloiste NA+ Cloiste 15A Nanocor 1.30E Nanocor 1.34TCN
涂覆基质，Vytaflex 30 聚氨酯 聚氨酯 聚氨酯 聚氨酯 聚氨酯
底漆，Dow Corning 1200 无 无 无 无 无
基材，Dow Corning C6-135 硅酮 硅酮 硅酮 硅酮 硅酮
洋葱气味开始出现 30分钟 6小时 6小时 ＞12小时 ＞12小时
可以看出，添加2.5%的纳米复合材料显著提高了洋葱气味阻隔性。带有聚氨酯涂料但不含任何纳米复合材料的对比试验能够将封闭的硅酮管外部开始出现洋葱气味的时间从5分钟延长至30分钟。在将含有2.5%的纳米复合材料的聚氨酯涂料施涂到硅酮管上之后，洋葱气味开始出现的时间被延长到6-12小时。尽管臭味阻隔性提高,但是涂料粘附性不好。
实施例#3：由纳米复合材料组成的聚氨酯涂料，有底漆：
使用硅烷底漆（Dow Corning 1200）重复与实施例2同样的一套实验。观察到了相同程度的洋葱气味改善。就是说，在将含2.5%的纳米复合材料的聚氨酯涂料施涂到用硅烷涂底漆的硅酮管上之后，洋葱气味开始出现的时间从在不含任何纳米复合材料的对比试验中的30分钟延长到了6-12小时。聚氨酯涂料很好地粘附在硅酮管上，并且能够耐弯曲。  
纳米复合材料 没有 Cloiste NA+ Cloiste 15A Nanocor 1.30E Nanocor 1.34TCN
涂覆基质，Vytaflex 30 聚氨酯 聚氨酯 聚氨酯 聚氨酯 聚氨酯
底漆，Dow Corning 1200 有 有 有 有 有
基材，Dow Corning C6-135 硅酮 硅酮 硅酮 硅酮 硅酮
洋葱气味开始出现 30分钟 6.5小时 6小时 ＞12小时 ＞12小时
实施例#4：硅酮板中的纳米复合材料：
加入2%的Nanocor 1.30E制成1mm厚(即40mil)的硅胶板，Nusil 6350。根据ISO 8670-3:2000在硅酮板上比较在含有或不含有纳米复合材料的情况下的洋葱阻隔性。  
  不含纳米复合材料的1mm厚的硅酮板（对比试验） 含有2%的Nanocor 1.30E的1mm厚的硅酮板
洋葱气味开始出现 5-10分钟 60分钟
结果，加入2%的Nanocor 1.30E将硅酮板的洋葱气味阻隔性从5分钟提高到大约60分钟。
本发明的另一实施方案是臭味阻隔性改善的粪便导管，其具有小于60的肖氏A硬度，包含至少(a)一层硅烷偶联剂，和(b)至少一层纳米复合材料涂层。当施涂到硅酮粪便导管上时，此配制剂将产生不大于20,000cc/m2/天、或优选不大于10,000cc/m2/天、或更优选不大于5,000cc/m2/天的氧透过率。不使用硅烷偶联剂和没有纳米复合材料涂层的硅酮管具有大约37,500cc/m2/天的氧渗透速率。带有纳米复合材料涂层但不含硅烷偶联剂的硅酮管由于缺乏粘结而仅具有接近30,000-35,000cc/m2/天的氧渗透速率。或者，可将相同的配制剂施加到肖氏A硬度小于60的热塑性弹性体(TPE)或聚氨酯管(PU)上，从而将气体阻隔性提高到不大于25,000cc/m2/天、或优选不大于10,000cc/m2/天、或更优选不大于5,000cc/m2/天。
本发明所述的材料可以用作粪便导管。在使用中粪便袋一般连接到粪便导管。使用对于粪便导管所述的相同材料制造粪便袋。在实验室中得到了表1所示的对氧透过性和洋葱气味类似的臭味阻隔特性。这样，除了粪便导管之外，相同的材料构造可以用于造口袋。

Claims (20)

1.粪便导管，由臭味阻隔性材料制成，包含：
i) 热塑性弹性体，选自苯乙烯嵌段共聚物、热塑性硫化橡胶或聚烯烃弹性体；
ii) 臭味阻隔性改良剂，选自聚异丁烯、聚丁烯或有机粘土；和
iii) 防粘连剂，主要选自无机填料，包括硅石、滑石、粘土和云母。
2.权利要求1的粪便导管，其中所述苯乙烯嵌段共聚物包括苯乙烯-异戊二烯-苯乙烯(SIS)、苯乙烯-丁二烯-苯乙烯(SBS)、苯乙烯-乙烯/丁烯-苯乙烯(SEBS)、苯乙烯-乙烯/丙烯-苯乙烯(SEPS)或上述共聚物的共混物。
3.权利要求1的粪便导管，其中所述热塑性硫化橡胶包含可固化的橡胶与聚烯烃的共混物。
4.权利要求3的粪便导管，其中所述聚烯烃是聚乙烯和聚丙烯，包括它们的均聚物和共聚物。
5.权利要求3的粪便导管，其中可固化的橡胶选自乙烯丙烯二烯单体(EPDM)、乙烯丙烯橡胶和山都平以及它们的共混物。
6.权利要求1的粪便导管，其中所述聚烯烃弹性体包括烯烃嵌段共聚物，其中烯烃嵌段共聚物的晶相充当硬嵌段而无定形嵌段共聚物充当软嵌段。
7.权利要求1的粪便导管，其中所述有机粘土包括蒙脱石粘土、蒙皂石粘土、嵌入粘土、纳米粘土或上述粘土的混合物。
8.权利要求1的粪便导管，其中根据ASTM D3985的氧阻隔性透过率在23℃为1000cc/m2/天或更低。
9.权利要求1的粪便导管，具有的肖氏A硬度为60或更低。
10.权利要求1的粪便导管，具有的算术平均表面粗糙度Ra不小于0.1μm或优选不小于1μm。
11.权利要求1的粪便导管，其中粪便导管的表面可以用粘合强度大于5N/in的粘合剂粘结。
12.权利要求1的粪便导管，其中粪便导管的表面可以用焊接强度大于5N/in热焊接。
13.粪便导管，由臭味阻隔性材料制成，包含：
i) 热塑性弹性体，选自苯乙烯嵌段共聚物、热塑性硫化橡胶或聚烯烃弹性体；
ii) 臭味阻隔性改良剂，选自聚异丁烯、聚丁烯或有机粘土；和
iii) 防粘连剂，主要选自无机填料，包括硅石、滑石、粘土和云母，
所述臭味阻隔性材料具有60或更小的肖氏A硬度和不小于0.1μm或优选不小于1μm的算术平均表面粗糙度Ra。
14.权利要求13的粪便导管，其中根据ASTM D3985的氧阻隔性透过率在23℃为1000cc/m2/天或更低。
15.造口袋，由臭味阻隔性材料制成，包含：
i) 热塑性弹性体，选自苯乙烯嵌段共聚物、热塑性硫化橡胶或聚烯烃弹性体；
ii) 臭味阻隔性改良剂，选自聚异丁烯、聚丁烯或有机粘土；和
iii) 防粘连剂，主要选自无机填料，包括硅石、滑石、粘土和云母。
16.粪便导管，具有臭味阻隔性材料，包含：
弹性体，选自硅酮、聚氨酯、苯乙烯嵌段共聚物、热塑性硫化橡胶或聚烯烃弹性体；
纳米复合材料填料，其涂覆在所述弹性体上或存在于所述弹性体中以提供臭味阻隔性；
所述弹性体和纳米复合材料形成肖氏A硬度不大于60的软质导管用管。
17.权利要求16的粪便导管，其中所述导管用管在弯曲时不开裂。
18.权利要求16的粪便导管，其中所述用管是挤出的并且可以通过焊接和粘结而转化成。
19.粪便导管，含有臭味阻隔性材料，包含：
弹性体基材，在所述弹性体基材上包含含沸石的涂层；
所述弹性体和沸石形成肖氏A硬度不大于60的软质导管用管。
20.粪便导管，含有臭味阻隔性材料，包含：
硅酮管；
在所述管上的至少一层纳米复合材料涂层；和
至少一层硅烷偶联剂；
所述涂覆的管具有不大于20,000cc/m2/天的氧透过率。
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