CN1146449C - 导管的包装 - Google Patents
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
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Abstract
一种导管包装(10;110;210),它包括放置在可渗透消毒剂如环氧乙烷气体的内容器(2;102;202)中的导管(1;101;201)。有一能防止湿气渗入其内部的外容器(3;103;203)包封住内容器和导管组件。在外容器内可储存两条或两条以上的导管,它们分别装在各自的内容器中。
Description
技术领域
本发明涉及导管的包装以及将导管装入包装的方法。
背景技术
具有外表面涂层的导管面世已有多年。典型的情况是,涂层为亲水层,是设计来减小湿润条件下的摩擦系数的,目的是使导管能相对无痛苦地插入病人尿道,并在需要时相对无痛苦地拔出。
这类导管的典型实例已由欧洲专利说明书EP-B-0093093(Astra Meditec AB)和EP-B-0217771(Astra Meditec AB)公诸于世。EP-B-0093093公开了给例如胶乳导尿管这样的聚合物表面制作涂层的工艺,它的第一涂层包括有异氰酸酯化合物,第二涂层包括有聚乙烯吡咯烷酮。EP-B-0217771公开了一种制作改进的亲水涂层的方法,目的是在例如PVC导尿管这样的基底上保持较长的时间的滑溜性,方法是加进一种溶液,该溶液中含有一种溶剂,该溶剂中具有能增大渗透压的化合物如氯化钠。
通常导管都是包装在纸制包装中,以使它能在使用前进行消毒。这样的消毒典型地是在生产时运用本领域众所周知的技术如伽马射线辐照或环氧乙烷气体熏蒸来进行。如果是使用环氧乙烷,那就必须让它能接触到导管的表面,纸包装就可做到这一点。惯用的方法是用环氧乙烷能透过的纸,在其上网格状涂上聚乙烯,并将它沿边熔接在例如聚乙烯-聚丙烯、聚乙烯-聚对苯二甲酸乙二醇酯、或者也可能是聚乙烯-尼龙的层压在材料上。
本申请人曾观察到带涂层的导管所遇到的一个问题,就是导管的表面会变粘而粘结到包装的纸上而使导管的涂层受损、破坏或残缺。
有人曾建议在纸的内表面中夹入一层塑料材料,做成一个只在周边上封住的松松的纸-塑料层压材料,使导管不会直接与纸接触。但是,这种办法的缺点是,它给环氧乙烷渗入包装内部与导管的表面接触制造了障碍。这样的包装只能用辐照的方法来有效地消毒,虽然如此,但也可有变通的办法,那就是在塑料材料上开出多个裂缝,它要足够地细,能防止导管表面直接接触到纸,它在需要时又要能开到足够地宽,能让环氧乙烷进入包装。
这显然意味着生产过程变得不必要的复杂。特别是,这些塑料材料上的裂缝不得不进行细心的调整,以使它们不让导管表面接触到纸,同时又不以任何方式妨碍用环氧乙烷消毒。
发明内容
因此,需要有一种改进的导管包装,而本发明就提供了一种导管包装,它包括具有表面涂层、例如亲水外表面涂层的导管,以及包封导管并能让导管消毒剂、例如环氧乙烷通过的容器,其特征在于该容器是内容器,而该导管包装还包括有外容器,外容器包封着内容器并能防止或基本上防止湿气进入外容器内部。
这样的包装能克服现有技术所固有的缺点,而同时制作仍很简便。因此看来,导管表面发粘是由于在储存中湿气逐渐进入包装而引起的。
包装的外容器可用单层的塑料材料、例如聚乙烯或聚偏二氯乙烯(PVDC)来制作。但是,使用包括有金属层例如铝层的层压材料可制成更好的防潮隔离层。典型地可使用铝和聚乙烯的层压材料,将聚乙烯放在外容器的内侧。这样的材料可能是十分脆弱的,但可用加一层塑料材料的强化外层来补偿,这种塑料材料例如可用聚酯或取向聚丙烯如双轴取向聚丙烯。
本申请人还发现,防潮隔离层还可在外容器结构中使用氧化硅如二氧化硅来制得。氧化硅可被支撑在母体材料如聚酯、聚对苯二甲酸乙二醇酯(PET)、尼龙或聚丙烯中,或者被支撑在三菱公司销售的商品名为Techbarrier-S的材料中,并可被进一步用作制造外容器的层压材料中的一层。如果需要的话,还可在外容器的结构中再用一层塑料材料的强化外层。
另一种方法是,可使用镀金属膜,例如PET与氧化铝的镀金属膜。镀金属膜中的金属含量很小,这对环境有利,而且本申请人发现它是很好的防潮隔离层。在镀金属膜中可用尼龙和聚丙烯伯为聚对苯二甲酸乙二醇酯的替代物。
还可提到的是,聚三氟氯乙烯(PCTFE)也可作为外容器结构中的隔潮材料。
一条导管可储存在一个包装中。但是,由于导管只使用一次或很少次就要更换,因此可把两个或两个以上的导管分开储存在各个内容器中,而所有内容器都罩在一个外容器内。
在这种情况下,如果在从一个内容器中取出导管后能将外容器再次封住,那将是有利的。这一点可借助于提供一种能重新关闭外容器的装置、如拉链或多次使用的密封带(resealing tape)就可做到。
即使这样,在长期储存中仍有可能有少量的湿气会通过外容器渗透入内外容器之间的空腔内,或者当取出导管时也会进入,即使有重新关闭外容器的装置也不例外。本申请人发现,特别是当外容器为单层聚合物如聚乙烯时最易发生湿气渗透。这个问题可借助于在空腔内放置干燥剂来避免。典型的干燥剂可包括一小袋硅胶,或者分子筛或氯化钙。
本申请人发现,有时在生产导管或外容器时使用增塑剂或胶溶剂(solvents in glue)会在长期储存中在内外容器之间的空腔内积聚起恶臭气味。这个问题可借助于在空腔内放置除臭剂来解决。典型的除臭材料可包括一小袋活性炭。
这种包装特别适用于(虽然不仅仅适用于)与具有亲水涂层的导管结合使用。亲水涂层通常是或多或少对水敏感的,湿敏涂层的例子有:聚环氧乙烷、聚乙烯吡咯烷酮(PVP)和纤维素聚合物如羟乙基纤维素或羟丙基纤维素。涂层中可包括有增大渗透压的化合物如蔗糖、尿素或无机盐。典型地,这样的化合物是晶状的并很容易溶于水。适用的无机盐包括钠和钾的氯化物、碘化物、硝酸盐、柠檬酸盐和苯甲酸盐。
本发明还提供出一种制造导管包装的方法,它包括下列步骤:将具有表面涂层的导管封入内容器中,该内容器能让消毒剂通过并接触包封在其中的导管;将内容器和导管组件暴露在足以使导管消毒的消毒剂中;作为本发明的特征还包括如下步骤:即将内容器和导管组件包封在外容器内,该外容器能防止或基本上防止湿气进入其内部。
附图说明
现将以实施例、参照附图对本发明的实施方案进行描述,附图有:
图1为本发明第一实施方案的导管包装图,其中包括有包封着导管的内容器,以及包封着内容器的外容器;
图2A为图1中导管包装的横截面图;
图2B为图1中内容器器壁结构的横截面图;
图2C为图1中导管包装外容器器壁结构的横截面图;
图3为本发明第二实施方案的导管包装横截面图,它包括有多条各自装入内容器的导管,所有内容器都包封在一个外容器内;
图4为图3所示导管包装的另一视图;
图5为本发明第三实施方案的导管包装的横截面图,它包括有多条各自装入内容器的导管,所有内容器都包封在一个外容器内。
具体实施方式
请参看图1和图2A至2C,本发明第一实施方案的导管包装10,它包括有放置在内囊2中的导管1,内囊本身则放置在外囊3内。导管1例如可以是PVC导尿管,它涂有亲水涂层,该涂层中包括有增大渗透压的化合物如氯化钠,这是EP-B-0217771所公开的。
内囊2的结构是设计成能渗透环氧乙烷气体。从图2B中可以看出,内囊2是由第一种器壁部分和第二种器壁部分组成的,其中第一种器壁部分中包括有一层纸10’,其上成网格状涂有一层聚乙烯9;第二种器壁部分中包括有例如由一层聚乙烯8和一层聚丙烯7构成的层压材料,它被熔接在第一种器壁部分的边部上。第二种器壁部分也可使用聚乙烯-聚对苯二甲酸乙二醇酯层压材料,或者也可使用聚乙烯-尼龙层压材料,而边部也可采用卷边或折叠的方法来密封。如果不用纸的话,也可在第一种器壁部分中使用TyvekTM,它是杜邦公司销售的聚乙烯纤维的无纺材料。在此情况下,由于无纺材料本身能熔接成很好的封口,因此附加的聚乙烯层9就可以不要了。
另一方面,外囊3的结构则是要防止湿气与内囊2接触。如图2C所示,外囊3是用一种层压材料制成的,该层压材料由一层铝5和一层聚乙烯6组成,聚乙烯层6在外囊3的内层。在铝层5的外面复有一层聚酯外层4。外囊3各层的边用熔接法密封在一起。典型的厚度:聚乙烯层6为30~50μm,铝层5为8~10μm,聚酯层4为10~20μm。
另一种办法是,铝层5可用含有氧化硅的薄层来代替,例如用一层三菱公司销售的商品名为Techbarrier-S的氧化硅隔潮材料。也可用氧化铝或PCTFE来做隔潮层。
导管包装10的组装方法是,首先将导管1包封到内囊2中,然后将内囊2暴露在环氧乙烷气体中,直到导管1被消毒完毕为止。然后把内囊2包封在外囊3中。
已经查明,这种导管包装10的货架寿命至少可有一年,在此期间导管1的表面不会发粘。因此,导管1由于粘结在内囊2纸层10而发生的涂层损坏问题也就减轻了。
图3和4示出本发明第二实施方案的导管包装110。在该例中,在一个外囊103内部有多条导管101被储存在各自的内囊102内。内囊102和外囊103的结构与上述第一方案参照图1和图2A-2C所描述的相同。但是,这里在外囊3上装有一个拉链111,用它来打开或关闭外囊103,以使在某个时候取出一个内囊102的同时能保证其余的内囊102与外界空气接触的机会最少。
在外囊103与内囊102之间的空腔113内还放有一小袋硅胶112作干燥剂。在该空腔113内还放有一小袋活性炭114作除臭剂。
导管包装110的货架寿命也至少有一年,在此期间导管101的表面不会发粘。而且,用户在开启外囊103时不会面临有害气味。
导管包装110在生产时是先做好每个内囊102,把它围绕住内装的导管101,然后把内囊102的边熔接在一起而密封起来。理想的是一定数量的内囊102可做成一个单元,边的连接处应做成在需要时可把它们分开。然后把内囊102暴露在环氧乙烷气体中进行消毒,并吹风除去多余的环氧乙烷。也可有任选地包括辐照的步骤。
内囊102与硅胶小袋112和活性炭小袋114一道被聚集在一起。然后围绕它们做成外囊103。做到这一点的最便利的方法是利用预制的外囊103,它的四条边中的三条已被熔接密封在一起。然后把内装物品插入,再用熔接法照样密封外囊103的第四条边。
现请参阅图5,本发明第三实施方案的导管包装210中包括有数条导管201,分别储存在各自的内囊202中,内囊的结构与上述参照图1和图2A至2C所描述的第一方案的相同,这些内囊本身则储存在单个外囊203中。外囊203包括有一个真空成形的浅盘215,其上带有平的顶盖216。浅盘215和顶盖216都是用能防止湿气接触内囊202的隔潮材料制成的,并且可用相同的或不同的材料来制造。当然使用同样的材料方便。可提及的适宜材料有:聚丙烯、聚偏二氯乙烯(PVDC)、镀金属膜、以及铝与聚乙烯、聚酯、聚苯乙烯、聚丙烯或尼龙的层压材料。浅盘215有必要用真空成形法制造意味对它的厚度加有限制,但是顶盖216可使用任何合理的材料厚度。浅盘215的典型厚度可以是400~600μm,不过如使用刚性较大的材料时,厚度降为100或200μm也是可能的。浅盘215也可用泡沫材料如发泡聚苯乙烯来制造。
在外囊203的顶盖216上有做成一体的可多次使用的密封带211,用以开闭外囊203。因此,内囊202接触外界空气的机会被减到了最少。
这种导管包装210在生产时,是先把内囊202聚集在一起,在将其暴露在杀菌剂如环氧乙烷气体中以后,再围绕它们组装外囊203。做到这一点的最便利的方法是,把内囊202放到外囊203真空成形的浅盘215的凹下部分中,然后用熔接法把外囊203的顶盖216的边密封到浅盘215上。浅盘215的深度,如图所示,要选择得能插入一层以上的导管排201。
Claims (15)
1.一种导管包装,它包括具有表面涂层的导管和能包封导管并能让导管消毒剂通过的容器,其特征在于,该容器是内容器,而导管包装还有外容器,该外容器能包封内容器并能防止湿气进入其内。
2.权利要求1的包装,其特征在于,外容器的结构包括带有金属层的层压材料。
3.权利要求1的包装,其特征在于,外容器的结构包括含有氧化硅的材料层。
4.权利要求2或3的包装,其特征在于,外容器包括一层塑料材料的强化外层。
5.权利要求1的包装,其特征在于,导管和内容器形成导管包装亚组件,而该导管包装在外容器内部包括一个或一个以上的导管包装亚组件。
6.权利要求5的包装,其特征在于,它备有可重复开闭外容器的装置。
7.权利要求1的包装,其特征在于,在内外容器之间放有干燥剂。
8.权利要求1的包装,其特征在于,在内外容器之间放有除臭剂。
9.权利要求1的包装,其特征在于,导管外表面涂层是亲水性的。
10.权利要求1的包装,其特征在于,消毒剂是环氧乙烷气体。
11.权利要求9的包装,其特征在于,亲水外表面涂层中包括增大渗透压的化合物。
12.权利要求9的包装,其特征在于,亲水外表面涂层包括选自钠和钾的氯化物、碘化物、硝酸盐、柠檬酸盐和苯甲酸盐的无机盐。
13.一种制造导管包装的方法,它包括下列步骤:将具有表面涂层的导管封入内容器中,该内容器能让消毒剂通过并接触包封在其中的导管;将内容器和导管暴露在足以使导管消毒的消毒剂中;其特征还包括进一步的步骤:即将内容器和导管包封在外容器内,该外容器能防止湿气进入其内部。
14.权利要求13的方法,其特征在于,该导管外表面涂层是亲水性的。
15.权利要求13或14的方法,其特征在于,消毒剂是环氧乙烷气体。
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Application Number | Priority Date | Filing Date | Title |
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SE9602352A SE9602352D0 (sv) | 1996-06-14 | 1996-06-14 | Catheter package |
SE96023528 | 1996-06-14 |
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CN1222091A CN1222091A (zh) | 1999-07-07 |
CN1146449C true CN1146449C (zh) | 2004-04-21 |
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CNB971954925A Expired - Lifetime CN1146449C (zh) | 1996-06-14 | 1997-06-12 | 导管的包装 |
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RU210621U1 (ru) * | 2022-02-09 | 2022-04-22 | Частное учреждение образовательная организация высшего образования "Медицинский университет "Реавиз" | Устройство для хранения и использования сосудистых зондов |
RU210756U1 (ru) * | 2022-02-09 | 2022-04-29 | Частное учреждение образовательная организация высшего образования "Медицинский университет "Реавиз" | Устройство для интраоперационного хранения и использования сосудистых зондов |
WO2024073419A1 (en) * | 2022-09-27 | 2024-04-04 | Hollister Incorporated | In-package aroma compound for medical device |
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GB2131384B (en) * | 1982-12-03 | 1986-01-15 | Smiths Industries Plc | Packaging for surgical apparatus |
JPH039741Y2 (zh) * | 1986-03-17 | 1991-03-11 | ||
DK530787D0 (da) * | 1987-10-09 | 1987-10-09 | Bukh Meditec | Indretning til indfoering i en legemshulhed |
US4779727A (en) * | 1987-11-25 | 1988-10-25 | Mallinckrodt, Inc. | Catheter packaging system |
JPH0329779A (ja) * | 1989-06-26 | 1991-02-07 | Kawasaki Steel Corp | 金属粉末の梱包体 |
JPH03162253A (ja) * | 1989-11-14 | 1991-07-12 | Baxter Internatl Inc | 引き剥がし調節手段を備える蓋付き容器 |
JP2526764Y2 (ja) * | 1991-03-26 | 1997-02-19 | 川澄化学工業株式会社 | カテ−テル包装容器 |
US5226530A (en) * | 1992-03-23 | 1993-07-13 | Golden John H | Prelubricated urinary catheter and package assembly |
JP3277943B2 (ja) * | 1992-05-21 | 2002-04-22 | 三菱瓦斯化学株式会社 | 二重包装体 |
DK0629415T3 (da) * | 1993-06-18 | 1999-10-11 | Schneider Europ Gmbh | Emballage, der under opbevaring og transport holder et medicinsk instrument under kontrollerede miljøforhold |
JP3534800B2 (ja) * | 1993-12-09 | 2004-06-07 | 大日本印刷株式会社 | 蒸着フィルムおよびその包装体 |
DE4412754C2 (de) * | 1994-04-13 | 1999-09-30 | Via Log Medikalprodukte Gmbh K | Verpackung eines medizinischen Instruments |
JPH08230952A (ja) * | 1995-02-28 | 1996-09-10 | Takiron Co Ltd | 包装体 |
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1996
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- 1997-06-12 RU RU99100641/14A patent/RU2184573C2/ru active
- 1997-06-12 HU HU9902841A patent/HU222366B1/hu active IP Right Grant
- 1997-06-12 DK DK97927576T patent/DK0910425T3/da active
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