CN1648011A - 灭菌包装 - Google Patents

灭菌包装 Download PDF

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CN1648011A
CN1648011A CNA200410100523XA CN200410100523A CN1648011A CN 1648011 A CN1648011 A CN 1648011A CN A200410100523X A CNA200410100523X A CN A200410100523XA CN 200410100523 A CN200410100523 A CN 200410100523A CN 1648011 A CN1648011 A CN 1648011A
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sterilization packaging
barrier film
semi
friction
sterilization
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S·－S·吴
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Johnson and Johnson Medical SAS
Ethicon Inc
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    • B65B55/02—Sterilising, e.g. of complete packages
    • B65B55/12—Sterilising contents prior to, or during, packaging
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    • B65—CONVEYING; PACKING; STORING; HANDLING THIN OR FILAMENTARY MATERIAL
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    • B65D81/00—Containers, packaging elements, or packages, for contents presenting particular transport or storage problems, or adapted to be used for non-packaging purposes after removal of contents
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    • A61L2/00—Methods or apparatus for disinfecting or sterilising materials or objects other than foodstuffs or contact lenses; Accessories therefor
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    • A61L2202/20—Targets to be treated
    • A61L2202/24—Medical instruments, e.g. endoscopes, catheters, sharps

Abstract

灭菌包装在灭菌过程中将设备封闭起来，之后在无菌状态下贮藏该设备。该包装包括隔离膜，其限定了一个内部空间，并将内部空间密封起来，使之与污染微生物隔离。至少一部分隔离膜由半透材料构成，其能渗透灭菌气体而不能渗透污染微生物。至少隔离膜外表面的一部分上具有增加摩擦的物质。

Description

灭菌包装
技术领域
本申请涉及灭菌过程中对货物的包装，更具体涉及带有摩擦增强物的包装。
背景技术
典型地，在灭菌前，将医疗器械或其它待灭菌设备放进包装中，其在灭菌后保护设备的无菌性，使灭菌过程对设备的灭菌产生影响。
一种流行的包装系统采用了两层薄膜，一层薄膜由透明的聚烯烃和聚酯的层压片形成，另一层由如TYVEKTM(纺粘聚乙烯)或者医用纸的半透膜形成。外周密封，例如采用粘合剂或熔化结合，将两层膜连结在一起，在它们之间限定一内部空间，其容纳要消毒的设备。TYVEKTM层对灭菌气体是可渗透的，灭菌气体为例如气相过氧化氢、臭氧、环氧乙烷以及蒸汽，然而不能渗透潜在的污染微生物。相似的，医用纸层对灭菌气体，例如环氧乙烷、臭氧以及蒸汽是可渗透的，然而不能渗透潜在的污染微生物。这种包装便宜且使设备灭菌效率高，并且在完成灭菌过程后保护这些设备的无菌。
这些和相似的包装很难堆叠，因为形成它们的材料具有相当低的摩擦系数。本发明克服了这种限制，而没有影响其用于很多种灭菌过程中的包装能力(即蒸汽，气相过氧化氢以及环氧乙烷)，没有对灭菌气体渗透包装的能力产生不利影响以及影响设备的灭菌。
发明内容
根据本发明的灭菌包装，用于在灭菌过程中封闭设备以及其后在无菌状态下贮藏设备。该包装包括隔离膜，其限定了一个内部空间，并密封该内部空间以隔离污染微生物。至少一部分隔离膜由半透材料构成，其对灭菌气体是可渗透的而对污染微生物是不能渗透的。至少该包装外表面的一部分上具有增加摩擦的物质。
优选的，隔离膜是柔软的。在灭菌包装的一种优选实施方案中，隔离膜由两个单独的薄膜板密封在一起形成。优选的，两个薄膜板上都具有增加摩擦的物质。优选的，薄膜板中的至少一个由半透材料组成，其一部分上具有增加摩擦的物质。该包装主要用于容纳医疗器械。
优选的，增加摩擦的物质包含弹性体，例如硅氧烷。
半透材料的一部分上可以具有增加摩擦的物质。优选将它以一种使部分半透材料未被增加摩擦的物质所覆盖的方式来使用。更优选的，该方式是均匀地分布在半透材料上，或者更优选地分布在整个隔离膜上，因此使其表面具有良好的防滑性，而没有阻碍灭菌气体从中透过。优选的，没有被增加摩擦的物质覆盖的半透材料部分超过25％。隔离膜的一部分可以由不透性材料形成，其不能渗透灭菌气体以及污染微生物，并且增加摩擦的物质可以位于不透性材料上。
特别地，当隔离膜包含CSR包装纸(wrap)时，通过折叠隔离膜而限定内部空间。
附图说明
图1是根据本发明的灭菌包装的透视图；
图2是在图1中包装表面上的增加摩擦的物质的详细图；
图3显示了根据本发明的一种可供选择的灭菌包装在折叠前的顶视图；以及
图4显示了图3中的包装在折叠后的顶视图。
具体实施方式
图1显示了根据本发明的袋10。该袋包含由TYVEKTM、纺粘聚乙烯、或者医用纸形成的第一半透层12，由层压透明的聚烯烃和聚酯14形成的第二层。半透膜12和透明膜14沿着由粘合剂形成的外周密封16结合在一起。可选择地，密封可以由熔化结合或者任何其它适当的密封方法形成。器械18被容纳在半透层12和透明层14之间形成的内部空间20内。
也转到图2，可以看到，透明层14的外表面23上具有增加摩擦的物质22。相似图样(pattern)的增加摩擦的物质22被置于例如由TyvekTM或者医用纸12形成的半透膜的外表面上(没有显示)。增加摩擦的物质以一种不干涉半透层12对灭菌气体的渗透性的图样被放置，同时也不过度消弱通过透明层14对器械18的可见性。尽管显示了一种特定图样，也可以使用其它图样，规则的或者不规则的。
增加摩擦的物质22比下面的透明层14和半透层12具有大得多的静摩擦系数。优选的静摩擦系数至少为0.2，更优选的为0.3或更大。适合的材料包括热塑或热固型的聚合弹性体，塑料以及潜在的陶瓷或者金属。应该基于与传统灭菌技术的相容性及静摩擦系数来选择材料。通过印刷，例如丝网遮蔽法，凹版印刷或者苯胺印刷方法涂覆物质22，以致能监测和控制沉积物的厚度和印刷图样。只要以特定图样施用涂层，也可以使用其它传统的涂布方法，例如喷涂法或者流延法。在印刷前，将增加摩擦的物质22溶解或混悬在水或溶剂中。
增加摩擦的物质22的一种特别有用的形式是硅氧烷，例如聚二甲基硅氧烷或聚二苯基甲基硅氧烷及其衍生物，其能悬浮在溶剂或水溶液中，并被印刷到半透膜12和/或透明层14上。特别优选硅氧烷，因为它耐蒸汽热，大多数级别不产生干扰并且过氧化氢或环氧乙烷对其不产生不利的化学影响。也可以选择具有相当大的静摩擦系数的硅氧烷。
本发明不局限于特定的袋结构。例如，两层可以由一种半透材料制成，诸如TYVEKTM，医用纸或具有过滤细菌特性的非织造材料，例如CSR包装纸。典型地，CSR包装纸由单层或层压的非织造聚丙烯形成，如SMS(纺粘—熔喷—纺粘)，其可渗透灭菌蒸汽，而不能渗透潜在的污染微生物。可供选择地，两层都可由非渗透材料构成，具有一个或多个半透材料形成的窗口，以供消毒气体透过。使用封闭16前，各层可以是分开的，或者可以将一片材料自身折叠并密封在一起。此外，摩擦增强的物质22可以仅应用到一侧如透明层一测，但优选应用到袋10的两侧。如果制成的袋10具有半透材料形成的窗口，摩擦增加的物质22可应用到包装的其它部分，而不应用到窗口部分。
图3和图4说明了一种可供选择的包装形式。将设备18包裹在一片或多片CSR(中心供应空间)包装纸24内。图4所示的折叠构型30由胶带或粘合剂26粘结在一起。胶带或粘合剂26可以印有化学指示剂油墨，在暴露于消毒气体时，该油墨改变颜色。采用使CSR包装纸24可透过消毒气体并使裹起来的包装30摩擦增大的方式，将摩擦增强的物质28涂敷到CSR包装纸24上。
典型地，CSR包装纸由单层或层压的非织造聚丙烯制成，如SMS(纺粘—熔喷—纺粘)，并且可透过消毒蒸汽，不透过潜在的污染微生物。在灭菌过程中，使用它包装灭菌盘，也可以包装用于灭菌的单个器械。本发明的CSR包装纸24具有增加摩擦的物质28，以致围绕器械18包裹而形成包装30，包装30由于增加摩擦的物质28而具有防滑性。增加摩擦的物质仅仅需要应用到CSR包装纸24的一个侧面，其位于已完成的包装30的外侧面上。可以采用任何图样，不需要是规则的，但是应以这样的方式应用，即不阻碍CSR包装纸24对灭菌气体的渗透性，并且不干扰胶带或胶粘物26的粘附。
现在，已经对本发明进行了详细描述，作出多种改装和变换对本领域普通技术人员来说是显而易见的，没有偏离由下面的权利要求所限定的本发明的主题或范围。

Claims (16)

1.一种灭菌包装，用于在灭菌过程中封闭设备且之后在无菌状态下贮藏该设备，该包装包括：
限定内部空间的隔离膜；
该隔离膜将内部空间封闭起来，使之与污染微生物隔开；
至少一部分隔离膜由半透材料构成，其能渗透灭菌气体，而不能渗透污染微生物；以及
至少一部分包装外表面上有增加摩擦的物质。
2.根据权利要求1的灭菌包装，其中，隔离膜是柔软的。
3.根据权利要求2的灭菌包装，其中，隔离膜由经外周密封而密封在一起的两个单独膜板构成。
4.根据权利要求3的灭菌包装，其中，两个膜板上有增加摩擦的物质。
5.根据权利要求3的灭菌包装，其中，至少一个膜板由半透材料构成，其一部分上有增加摩擦的物质。
6.根据权利要求1的灭菌包装，其容纳有医疗器械。
7.根据权利要求1的灭菌包装，其中，增加摩擦的物质包含弹性体。
8.根据权利要求7的灭菌包装，其中，该弹性体包含硅氧烷。
9.根据权利要求1的灭菌包装，其中半透材料的一部分上具有增加摩擦的物质。
10.根据权利要求1的灭菌包装，其中，增加摩擦的物质以使部分半透材料未被该增加摩擦的物质覆盖的图样位于半透材料上。
11.根据权利要求10的灭菌包装，其中，该图样是均匀分布于半透材料上。
12.根据权利要求11的灭菌包装，其中该图样是均匀分布于隔离膜上。
13.根据权利要求10的灭菌包装，其中半透材料没有被增加摩擦的物质所覆盖的部分超过25％。
14.根据权利要求1的灭菌包装，其中内部空间通过折叠隔离膜进行限定。
15.根据权利要求14的灭菌包装，其中，隔离膜包含CSR包装纸。
16.根据权利要求1的灭菌包装，其中，隔离膜的一部分由不透性材料构成，其不能渗透灭菌气体和污染微生物，并且增加摩擦的物质位于不能渗透的材料上。
CNA200410100523XA 2003-10-31 2004-10-29 灭菌包装 Pending CN1648011A (zh)

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