CN111032323B - 用于密封医疗器械的方法 - Google Patents

用于密封医疗器械的方法 Download PDF

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CN111032323B
CN111032323B CN201880051835.6A CN201880051835A CN111032323B CN 111032323 B CN111032323 B CN 111032323B CN 201880051835 A CN201880051835 A CN 201880051835A CN 111032323 B CN111032323 B CN 111032323B
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C·阿斯曼
拉尔夫·弗利格
沃尔夫冈·弗罗伊登曼
托斯坦·克内尔
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Gambro Lundia AB
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Abstract

本公开涉及密封医疗器械(例如，过滤和/或扩散器械，如超滤器和毛细管透析器)的端口的方法。

Description

用于密封医疗器械的方法
技术领域
本公开涉及密封医疗器械(例如，过滤和/或扩散器械，如超滤器和毛细管透析器)的端口的方法。
发明背景
在一些医疗器械(例如，过滤和/或扩散器械)的生产过程中，器械端口可能必须被永久密封。例如，用于在装配过程中向器械中引入液体或固体的端口可能必须被永久密封以防止内容物从器械中泄露。另外，在成品器械中多余的端口需要被永久密封，以防止任何液体或固体通过各自的端口逸出以及对器械内部空间的任何污染。
这样的端口通常通过诸如摩擦焊接、超声焊接或镜面焊接的焊接技术或通过使用粘合剂将塞头粘在端口中来密封。然而，在某些情况下，无法使用这些密封技术，因为它们可能会损坏产品或无法有效密封端口。特别是在器械内部包含液体或具有易碎结构的情况下，施加超声波或过多的热量可能会损坏器械的内容物。另一方面，粘合剂可能会污染器械的内容物或由于与器械的内容物相互作用而无法提供永久密封。
期望有一种替代的密封方法，其可靠地为医疗器械的端口提供永久密封；不损害器械的内容物；并可用于密封包含液体或固体的器械的端口。
发明概述
本公开提供了一种用于永久密封医疗器械的端口的方法。该方法使用收缩管来密封端口与封闭端口开口的塞子或盖的接合处。
详细描述
本公开提供了一种用于密封医疗器械的端口的方法。该方法包括用盖或塞子封闭端口的开口；用收缩管至少覆盖端口与塞子或盖的接合处；和使收缩管收缩以密封端口。
在一个实施方案中，医疗器械是过滤和/或扩散器械。在另一个实施方案中，医疗器械是用于容纳液体(例如溶液、分散液或凝胶)和/或颗粒状材料(例如粉末或颗粒)的容器，特别是袋或小袋。在一个实施方案中，医疗器械是透析器、超滤器或血浆过滤器。在一个实施方案中，医疗器械包含中空纤维膜。在另一个实施方案中，医疗器械包含至少一个平板膜。在另一个实施方案中，医疗器械包含液体。在另一个实施方案中，医疗器械包含颗粒状材料，例如聚合物珠或碳颗粒。在一个特定实施方案中，医疗器械是包含中空纤维膜并填充有液体的过滤和/或扩散器械。在另一个特定实施方案中，医疗器械是包含中空纤维膜、颗粒状材料和液体的过滤和/或扩散器械。在一个实施方案中，颗粒状材料位于围绕中空纤维膜的空间中。
在一个实施方案中，端口由玻璃、金属或陶瓷构成。在另一个实施方案中，端口由聚合物材料构成。实例包括聚碳酸酯(PC)、聚丙烯(PP)、聚甲基丙烯酸甲酯(PMMA)和环烯烃共聚物(COC)。
在一个实施方案中，端口是过滤和/或扩散器械的壳体的组成部分。在一个实施方案中，壳体由聚合物材料构成。合适的聚合物材料包括聚碳酸酯(PC)、聚丙烯(PP)、聚甲基丙烯酸甲酯(PMMA)和环烯烃共聚物(COC)。在一个实施方案中，端口是管状的。在一个实施方案中，端口是如DIN EN ISO 8637(2014)所述的用于血液过滤、血液透析过滤或血液透析的过滤和/或扩散器械的连接器。在一个特定实施方案中，端口是鲁尔接头。在另一个特定实施方案中，端口是汉森连接器。
在本公开的方法的第一步中，用盖或塞子封闭要密封的医疗器械的端口的开口。在一个实施方案中，通过将盖放置在端口的开口上来封闭端口的开口。盖在端口的孔口和端口的外部的一部分上延伸。盖的内径与端口的外径匹配，使得端口的外部与盖的内壁之间的间隙很小，例如0.05至小于1mm。在另一个实施方案中，端口的外部具有螺纹，并且盖的内部具有匹配的螺纹并且将盖拧到端口上。在另一个实施方案中，通过将塞子或塞头插入到端口的开口中来封闭端口的开口。在一个实施方案中，塞子为圆锥形，其最小直径小于端口的开口的直径，并且其最大直径大于端口的开口的直径。在插入后，塞子的一部分从端口的开口中突出。在另一个实施方案中，塞子具有圆柱形或圆锥形的部分，该部分的最大直径小于端口的内径；以及头部，该头部具有与端口的外径匹配的直径。在插入后，塞子的头部覆盖端口的开口和边缘。端口的边缘与塞子的头部之间的间隙优选很小，例如0.05至小于1mm。
在一个实施方案中，塞子由玻璃构成。在另一个实施方案中，塞子由聚合物材料构成。实例包括聚碳酸酯(PC)、聚丙烯(PP)、聚甲基丙烯酸甲酯(PMMA)和环烯烃共聚物(COC)。
在一个实施方案中，要封闭的端口和塞子或盖由相同的材料构成。在另一个实施方案中，要封闭的端口和塞子或盖由具有相似的热膨胀系数的材料构成。端口和塞子或盖使用相同的材料或具有相似的热膨胀系数的材料可防止在端口密封期间和之后形成应力裂纹。
在用塞子或盖封闭端口的开口之后，至少将端口与塞子或盖的接合处分别用收缩管覆盖。收缩管的内径分别略大于端口的外径和塞子或盖的外径。在一个实施方案中，收缩管的内径比端口的外径大1至10mm。收缩管至少分别覆盖端口与塞子或盖的接合处。在一个实施方案中，长度为5至30mm的收缩管的一部分用于覆盖端口与塞子或盖的接合处和相邻部分。在另一个实施方案中，使用收缩盖(即，在一端封闭的收缩管)来覆盖端口和塞子或盖在接合处上延伸的部分。在一个实施方案中，收缩帽在接合处上扩展并延伸超过接合处，例如，超过的长度在5至30mm的范围内。在一个实施方案中，收缩管在收缩后具有0.2至2.5mm的壁强度。
在本公开的方法的一个实施方案中，收缩管由至少一种弹性体(例如
Figure BDA0002381418160000031
)构成。在一个实施方案中，收缩管由至少一种聚烯烃、硅酮、聚氯乙烯(PVC)或含氟聚合物构成。合适的含氟聚合物的实例包括聚偏二氟乙烯(PVDF)、聚四氟乙烯(PTFE)、氟化乙烯丙烯(FEP)和全氟烷氧基烷烃(PFA)。
在一个实施方案中，收缩管的内腔涂覆有粘合剂。合适的粘合剂的例子包括聚酰胺热熔粘合剂、聚烯烃热熔粘合剂、氟化乙烯丙烯(FEP)和全氟烷氧基烷烃(PFA)。在收缩步骤过程中，粘合剂在管和端口之间形成额外的粘结，固定该管并防止管从端口滑落。这对于锥形端口特别有用。
随后使收缩管收缩以密封端口。在一个实施方案中，通过加热收缩管来实现收缩过程。根据所使用的收缩管的类型，收缩温度在80至330℃的范围内，例如在90至175℃或90至120℃的范围内。
可以在医疗器械的灭菌之前或期间执行收缩步骤。在该方法的一个实施方案中，通过用蒸汽对医疗器械进行灭菌来执行收缩管的收缩。在蒸汽灭菌过程中，将医疗器械加热到115至121℃的温度范围。
收缩管的收缩率(即，收缩步骤之前的直径与收缩步骤之后的直径之比)通常在1.3:1至5:1的范围内，尤其是在2:1至4:1或3:1至4:1的范围内。
本公开还涉及收缩管用于密封医疗器械的端口的用途。在一个实施方案中，收缩管的内腔涂覆有粘合剂。
实施例
除非另外说明，否则在每个实施例中，用由聚碳酸酯构成的塞子来封闭由聚碳酸酯构成的血液透析器壳体的透析液端口。塞子头部的直径约为15mm，因此，在插入到端口中之后，其轮廓与透析液端口的外径齐平。
实施例1
使30mm的内部涂覆有聚酰胺热熔粘合剂且内径为16mm的柔性的辐射交联的聚烯烃管(
Figure BDA0002381418160000041
FT800E-HT-16/4；GREMCO GmbH，D-86165 Augsburg)在塞子和端口上滑动，使管的末端超出塞子的头部5mm。材料的收缩温度为110℃，收缩比为4:1。
将该器械在高压釜中于116℃蒸汽灭菌2小时。在高压釜中的总时间为4小时。在设备上执行的泄漏测试确认密封在器械中在1.6bar压力下是紧密的。
实施例2
a)使30mm的内部涂覆有基于聚酰胺的热熔粘合剂且内径为19mm的柔性的辐射交联的管(
Figure BDA0002381418160000042
FT881-1900；GREMCO GmbH，D-86165Augsburg)在塞子和端口上滑动，使管的末端延伸超出塞子的头部5mm。材料的收缩温度为120℃，收缩比为2:1。
将若干器械在烘箱中加热至120℃，并在120℃下保持2小时。对器械进行了泄漏测试，以确定在器械中压力为1.6bar时密封是否紧密。随后将器械在116℃下用蒸汽灭菌2小时，然后重复泄漏测试。第二次泄漏测试证实通过了第一次泄漏测试的那些器械的密封仍然完好无损。此外，即使那些未通过第一次泄漏测试的器械也已通过蒸汽灭菌过程而被密封并通过了第二次泄漏测试。
b)使30mm的内部涂覆有基于聚酰胺的热熔粘合剂且内径为19mm的柔性的辐射交联管(
Figure BDA0002381418160000051
FT888-19/6透明；GREMCO GmbH，D-86165Augsburg)在塞子和端口上滑动，使管的末端延伸超出塞子的头部5mm。材料的收缩温度为120℃，收缩比为3:1。
将该器械在烘箱中加热至120℃，并在120℃下保持2小时。在器械上执行的泄漏测试确认密封在器械中在1.6bar压力下是紧密的。随后将该器械在121℃下用蒸汽灭菌21分钟，并重复泄漏测试。泄漏测试证实密封仍完好无损。
实施例3
在该实施例中，使用外径为18.4mm的螺口式聚丙烯盖代替聚碳酸酯塞子来封闭透析液端口。
使30mm的内部涂覆有基于聚酰胺的热熔粘合剂且内径为25.4mm的柔性的辐射交联管(
Figure BDA0002381418160000052
FT881-2540；GREMCO GmbH，D-86165Augsburg)在盖子和端口上滑动，使管的末端延伸超出盖子的头部5mm。材料的收缩温度为120℃，收缩比为2:1。
将该器械在烘箱中加热至120℃，持续2小时。在器械上执行的泄漏测试确认了密封在器械中在1.6bar压力下是紧密的。随后将该器械在高压釜中在116℃下用蒸汽灭菌2小时，并重复泄漏测试。泄漏测试确认了密封仍然完好无损。

Claims (10)

1.一种用于密封为过滤和/或扩散器械的壳体的组成部分的端口的方法，其包括：
用盖或塞子封闭端口的开口；
用收缩管至少覆盖端口与塞子或盖的接合处，其中所述收缩管的内腔涂覆有粘合剂；和
使收缩管收缩以密封端口，其中通过在115℃至121℃的温度下用蒸汽对过滤和/或扩散器械进行灭菌来执行所述收缩管的收缩。
2.如权利要求1所述的方法，其中所述过滤和/或扩散器械是透析器。
3.如权利要求1或2所述的方法，其中所述过滤和/或扩散器械包含液体。
4.如权利要求1所述的方法，其中所述过滤和/或扩散器械包含颗粒状材料。
5.如权利要求1所述的方法，其中过滤和/或扩散器械的壳体由聚合物材料构成，所述聚合物材料选自聚碳酸酯、聚丙烯、聚甲基丙烯酸甲酯和环烯烃共聚物。
6.如权利要求1所述的方法，其中所述端口和所述塞子由相同的材料构成。
7.如权利要求1所述的方法，其中所述粘合剂选自聚酰胺热熔粘合剂、聚烯烃热熔粘合剂、氟化乙烯丙烯和全氟烷氧基烷烃。
8.收缩管用于密封为过滤和/或扩散器械的壳体的组成部分的端口的用途，所述端口的开口用盖或塞子封闭，其中所述收缩管的内腔涂覆有粘合剂，所述粘合剂选自聚酰胺热熔粘合剂、聚烯烃热熔粘合剂、氟化乙烯丙烯和全氟烷氧基烷烃，且其中通过在115℃至121℃的温度下用蒸汽对过滤和/或扩散器械进行灭菌使收缩管收缩。
9.如权利要求8所述的用途，其中所述过滤和/或扩散器械包含中空纤维膜且填充有液体。
10.如权利要求9所述的用途，其中所述过滤和/或扩散器械包含位于围绕中空纤维膜的空间中的颗粒状材料。
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