CN86103457A - 辐射灭菌的封装式医疗装置 - Google Patents
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Abstract
一种封装式医疗装置,其中包括一个医疗器械,一个其中盛装有该医疗器械的透气性无菌袋,一个由氧不能透过的材料制成的外封包件,其中封装有预先经过辐射灭菌的盛装有医疗器械的袋子,以及与该盛装有医疗器械的袋子一起装入外封包件中的除氧剂。这种封装的医疗器械在开封时不放出臭味,而且其塑料部件的强度也不会降低。
Description
本发明是关于辐射灭菌的医疗装置。更具体地讲,本发明是关于装设有除臭装置的封装式医疗装置,该除臭装置用来防止从无菌盛装袋中取出辐射灭菌的医疗器械时发出臭味。
近年来,尤其在用后即丢的医疗器械领域中,广泛使用γ-射线灭菌法作为医疗器械的灭菌方法。为了使这种用后即丢的医疗器械在使用之前一直保持无菌,通常将其封装在一个无菌袋中,然后在预先包装在此袋中的情况下用γ-射线加以灭菌。但是,由于袋中存在氧,当使用γ-射线或其它射线照射时,氧被激发生成臭氧〔氧的同素异形体〕,因此产生据认为与臭氧有关的所谓γ-臭味。当将此无菌袋开封,从中取出医疗器械时发出这种臭味,给器械的使用者以不舒适的感觉。
而且,用后即丢的医疗器械通常是用某些塑料或其它材料制成的,由于依时氧化作用可以使之强度降低。尤其是于气体气氛中进行干燥辐射灭菌时,塑料表面曝露于空气之中,存在有辐射激发的氧,在较高的温度下进一步促进了塑料的依时氧化作用,从而导致强度降低。
鉴于上面提到的问题,本发明人进行深入研究之后发现,这些问题均来源于氧的存在。因此,本发明人寻找了消除氧的方法。
本发明的目的在于提供一种干燥辐射灭菌的医疗装置,这种装置在开封时不放出臭味,而且其塑料部件的强度也不减弱。
本发明的这个目的和其它目的,经过以下描述之后会显得更清
本发明提供了一种封装式的医疗装置,其中包括一个医疗器械;一个其中装有该医疗器械的透气性无菌袋;一个由氧不能透过的材料制成的外封包件而且其中封装有预先经过辐射灭菌的、装有医疗器械的上述袋子;以及与装有医疗器械的袋子一起盛装在上述外封包件中的除氧剂。
图1是表明本发明的一种封装式医疗装置的示意说明图。
在本发明中,所说的辐射灭菌最好是使用γ-射线辐射灭菌,所说的除氧剂最好是以活化的氧化铁为基质的除氧剂。本发明可以有效适用的医疗器械包括:空心纤维血液处理器,尤其是使用醋酸纤维素空心纤维膜的血液处理器,一般认为这种处理器与干燥辐射灭菌作用是互不相容的。所说的氧不能透过的材料最好是叠层的聚酯-铝-聚乙烯薄片。
本发明是把封装在无菌袋中的医疗器械经过辐射灭菌之后,与除氧剂一起密封在氧不能透过材料的外封包件中。因此,从外部环境基本上没有氧渗入,而且既使在包装步骤期间封入的氧也被共存的除氧剂所吸附。从而,可以使外封包件内部保持缺氧的状态,以成功地防止发生臭味以及医疗器械强度的老化作用。
此外,由于所说的无菌袋是透气性无菌袋,所以袋中存在的氧和臭氧以及从医疗器械上逐渐释放出的氧,也立刻被吸附掉。
加之由于外封包件是由氧不能透过的材料制成的,所以几乎完全阻止了氧自外部环境进入,因而可以在长时间之内保持外封包件内部处于无氧状态下。
现在参照附图说明本发明的优选实施方案。
参照图1,本发明的封装式医疗装置包括一个医疗器械1,例如空心纤维血液处理器,此器械被封装在一个无菌袋2中并且与除氧剂3一起被密封在一个外封包件4之中。也就是说,此医疗器械1本身首先被封装在无菌袋2之中,用γ-射线灭菌之后再与除氧剂3一起密封在外封包件4之中。
无菌袋2是透气性无菌袋,而外封包件4是由氧不能透过的材料制成的。使用这种透气性袋作为无菌袋的理由是,如果使用的是气体不能透过的无菌袋,那么即使在无氧条件下封装,医疗器械本身原有的氧逐渐放出并且积聚在该无菌袋中,如经验所证明,那样会在较高的温度下加速该医疗器械强度的降低。
本发明中所用的术语“无菌袋”是指在其中盛装有某医疗器械的状态下经过灭菌处理的而且细菌不能通过其壁的一种袋子。此无菌袋既可以是全部表面均能透气,也可以是部分表面透气。
这种无菌袋的实例包括:(1)两侧均是用叠层的聚酯-聚乙烯膜制造的袋子,在该叠层膜上有一个或多个透气部分,这是在叠层膜上有例如狭长切口之类的一个或多个开孔,在这些开孔部位覆盖有某种聚乙烯非机织织物(non-woven fabric)或不含磨木浆纸(wood-free paper);(2)一侧是由不含磨木浆纸或聚乙烯非机织织物制成,另一侧是由叠层的聚酯-聚乙烯膜制成的袋子;(3)两侧均是用不含磨木浆纸或聚乙烯非机织织物制成的袋子。
使用由氧不能透过的材料制造外封包件的目的在于防止氧从外部环境渗入,从而确保除氧剂具有长的有效期。本发明所使用外封包件的实例包括:由外层聚酯膜、中间层铝箔(或铝沉积层)和内层聚乙烯膜构成的叠层薄片,由外层聚酯膜、中间层聚乙烯膜、中间层铝箔(或铝沉积层)和内层聚乙烯膜构成的叠层薄片,由外层双轴取向的聚丙烯膜、中间层乙烯-乙烯醇共聚物膜和内层聚乙烯膜构成的叠层薄片,由外层聚乙烯醇纤维膜(其两侧均涂有聚偏二氯乙烯)和内层聚乙烯膜构成的叠层薄片,由外层双轴向取向的聚乙烯醇膜和内层聚乙烯膜构成的叠层薄片,由外层涂有聚偏二氯乙烯的取向的聚丙烯膜和内层聚乙烯膜构成的叠层薄片,由外层涂有聚偏二氯乙烯的聚酯膜和内层聚乙烯膜构成的叠层薄片,由外层涂有聚偏二氯乙烯的取向的尼龙膜和内层聚乙烯膜构成的叠层薄片,由外层涂有聚偏二氯乙烯的赛璐玢和内层聚乙烯膜构成的叠层薄片,以及由多层的耐冲聚苯乙烯-聚偏二氯乙烯-聚乙烯叠层膜和内层未取向的聚丙烯膜构成的叠层薄片。从成本和效率的观点来看,最好的氧不能透过材料的实例是由外层聚酯膜、中间层铝箔(或铝沉积层)和内层聚乙烯膜构成的叠层薄片,和由外层聚酯膜、中间层聚乙烯膜、中间层铝箔(或铝沉积层)及内层聚乙烯膜构成的叠层薄片。
灭菌的方法可以是任何辐射灭菌法,其中包括γ-射线灭菌法和电子束灭菌法。但是,在采用对医疗器械强度有较大影响的γ-射线灭菌法时,本发明更为有效,因为本发明把医疗器械和除氧剂一起封装在氧不能透过的外封包件中,其效果在采用γ-射线灭菌法时显著地表现出来,尤其是考虑到由于受辐射激发的氧造成医疗器械强度降低的问题时更是如此。
辐射灭菌时所用的吸附剂量,视医疗器械的种类和射线的种类而定。用γ-射线对空心纤维血液处理器灭菌时,通常采用的吸附剂量为1.8-2.5毫拉德。
因为除氧剂是与盛装在一个透气性无菌袋中的医疗器械封装在一起,所以除氧剂必须无毒。而且除氧剂最好是那种在吸附氧之后不产生气体(氢气、二氧化碳气等)的物质。基于这些原因,除氧剂最好以活性金属或活性金属化合物为基质,而且其反应速率等受催化剂的控制。所说的活性金属或活性金属化合物,例如可以是铁、锌、铜、或锡,或者是上述金属的氧化物,但在目前可以买到的除氧剂中,以活性氧化铁为基质的除氧剂最好。Ageless(三菱气体化学公司的商品名)是市场供应的这类除氧剂之一。这种除氧剂盛装在一个透气性袋或容器之中。
按照本发明,必须把装有医疗器械的袋子事先灭菌,然后与除氧剂一起封装在氧不能透过的外封包件中。也就是说,一定不能把医疗器械与除氧剂一起封装在某种气体不能透过的袋子中,也不能在袋子中已有除氧剂的情况下进行辐射灭菌处理。其理由是,如果于除氧剂在袋子中存在的情况下对装有医疗器械的袋子进行辐射灭菌,就会导致D值(是指与辐照之前相比,细菌数目减小到1/10时所需的吸附剂量)增加。对于使用醋酸纤维素空心纤维的医疗器械来说,这种趋势显得特别明显,实施例4说明了这一点。对于使用硅橡胶空心纤维的医疗器械,也观察到这个趋势。
作为除去无菌袋中所产生的臭味的方法,可以考虑把活性炭作为除臭剂与医疗器械一起封装,但是鉴于活性炭所占的体积比典型除氧剂大十倍这个事实,以及在较高的温度下其除臭效率差和不能阻止强度依时降低的事实,使用活性炭不适于本发明的目的。
参照要按本发明加以封装的医疗器械,按照本发明的抑制强度降低的方法,即包括将盛装在一个透气性无菌袋中的医疗器械,在辐射灭菌之后与除氧剂一起封在一个氧不能透过的外封包件中,这个方法可以用于任何基本上由塑料制成的医疗器械的辐射灭菌。例如,本发明对于那些即使不采取任何防止强度降低的专门措施,其强度损失也在允许范围内的医疗器械来说,当然也是有效的。但是,如果从成本和效率的观点来看,本发明最好用在空心纤维血液处理器上,尤其是采用醋酸纤维素空心纤维膜的血液处理器上。空心纤维血液处理器的典型实例包括人工肾的渗析器。也可优先把本发明用于使用硅橡胶空心纤维膜和硅橡胶制导管的人工肺上。
通过下列实施例对本发明作更详细的描述和说明。应当知道,本发明并不受这些实施例的限制。在不背离本发明精神实质和范围的前提下,可以按照本发明做出各种改变和修改。
实施例1
在一个两侧均是由聚酯-聚乙烯叠层膜制成的、而且其一侧有被聚乙烯非机织织物覆盖的狭长切口部分的透气性无菌袋中,放入一个渗析器,然后将此袋子密封。该渗析器含有一束醋酸纤维素空心纤维,该束纤维有8800根,每根的有效长度为20厘米,外径为230微米,内径为200微米。通过2.5毫拉德剂量的γ-射线照射,使盛装渗析器的袋子灭菌。将经过灭菌的袋子,与作为除氧剂的10克Ageless一起放入袋形外封包件中,此外封包件由叠层薄片制成,而且是热密封的。叠层薄片是由厚度为12微米的聚酯膜、厚度为9微米的铝箔和厚度为40微米的聚乙烯膜构成的,上述三层材料按上述顺序叠在一起。
每经过适当时间间隔测定除臭效果,结果列于表1之中。表1中,1W、2W和4W分别代表一周、两周和四周的存贮时间。表1中的符号含义如下:
O:未检测出臭味。
×:检测出臭味。
实施例2
除了使用另外一种叠层薄片作为外封包件之外,其余按照与实施例1相同的操作步骤进行试验。所用的叠层薄片是由厚度为12微米的聚酯膜、厚度为15微米的聚乙烯膜、厚度为9微米的铝箔和厚度为40微米的聚乙烯膜按上顺序叠成的。
试验结果列于表1之中。
比较例1和2
除了使用50克活性炭代替Ageless(比较例1)以及既不使Ageless也不使用活性炭(比较例2)之外,其余按照与实施例1相同的操作步骤试验。
试验结果列于表1之中。
表1的试验结果表明,使用除氧剂产生了显著的除臭效果。
实施例3
把与在实施例1中所用的相同的空心纤维,按照与实施例1相同的方式进行灭菌和包装。测定了该空心纤维强度的老化情况,所得试验结果列于表2之中。表2中的每个强度值均用十根空心纤维的平均值±标准偏差来表示。
比较例3
除了未用除氧剂之外,其余按照实施例3的操作步骤进行试验。试验结果列于表2之中。
表2的试验结果表明,使用除氧剂明显地有助于阻止因空心纤维的老化作用引起的强度降低。
实施例4
将与实施例1中所使用的相同的渗析器放在与实施例1中所使用的相同的无菌袋中,然后用γ-射线照射。相对于短小芽胞杆菌(Bacillus pumilus)ATCC 27142测定了D值。试验结果列于表3之中。
按照上述同样操作步骤,使用聚丙烯空心纤维渗析器或硅橡胶空心纤维人工肺进行试验。试验结果也列于表3之中。
比较例4
除了将每个医疗器械与Ageless一起放入与实施例1所用相同的氧不能透过的外封包件中,然后进行γ-射线照射之外,其余按照与实施例4相同的操作步骤试验。试验结果列于表3之中。
表3的结果表明,在除氧剂存在下进行γ-射线照射,特别是使用醋酸纤维素空心纤维时,使D值增加很大。因此,最好在无除氧剂存在下进行γ-射线照射。
除了在这些实施例中所使用的元件和成分之外,在这些实施例中也可以使用在说明书中说明的其它元件和成分来获得基本上相同的效果。
由上述说明可以明显地看出,由于本发明包括把盛装在一个透气性无菌袋中的医疗器械,与除氧剂一起进一步封装在一个氧不能透过的外封包件中这样一个步骤,所以可以除去外封包件中的氧和无菌袋中的氧,而且甚至于也可处理由所说医疗器械中逐渐放出的氧。
此外,由于外封包件是由氧不能透过的材料制做的,所以也基本上阻止了外部的氧进入,以致使除氧剂可以在很长时间内保持其功能。
Claims (9)
1、一种封装式医疗装置,其中包括:
--一个医疗器械,
--一个其中盛装该医疗器械的透气性无菌袋,
--一个由氧不能透过材料制成的外封包件而且其中封装有预先
经过辐射灭菌的、盛装有医疗器械的所说袋子,以及
--与盛装有医疗器械的袋子一起装入外封包件中的脱氧剂。
2、按照权利要求1所述的封装式医疗装置,其中所说的辐射灭菌是在气体气氛中的干燥辐射灭菌。
3、按照权利要求2所述的封装式医疗装置,其中所说的干燥辐射灭菌是用γ-射线灭菌。
4、按照权利要求1所述的封装式医疗装置,其中所说的除氧剂是以活性氧化铁为基质。
5、按照权利要求1所述的封装式医疗装置,其中所说的医疗器械是空心纤维血液处理器。
6、按照权利要求5所述的封装式医疗装置,其中所说的空心纤维血液处理器是使用醋酸纤维素空心纤维膜的渗析器。
7、按照权利要求5所述的封装式医疗装置,其中所说的空心纤维血液处理器是使用硅橡胶空心纤维膜的人工肺。
8、按照权利要求1所述的封装式医疗装置,其中所说的氧不能透过的外封包件是聚酯-铝-聚乙烯叠层薄片。
9、按照权利要求1所述的封装式医疗装置,其中所说的氧不能透过的外封包件是聚酯-聚乙烯-铝-聚乙烯叠层薄片。
Applications Claiming Priority (2)
Application Number | Priority Date | Filing Date | Title |
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JP60214350A JPS6274364A (ja) | 1985-09-27 | 1985-09-27 | 医療用具 |
JP214350/85 | 1985-09-27 |
Publications (2)
Publication Number | Publication Date |
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CN86103457A true CN86103457A (zh) | 1987-03-25 |
CN1014863B CN1014863B (zh) | 1991-11-27 |
Family
ID=16654312
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Application Number | Title | Priority Date | Filing Date |
---|---|---|---|
CN86103457A Expired CN1014863B (zh) | 1985-09-27 | 1986-05-21 | 辐射灭菌的封装式医疗装置的制造方法 |
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US (1) | US4813210A (zh) |
EP (1) | EP0218003B1 (zh) |
JP (1) | JPS6274364A (zh) |
CN (1) | CN1014863B (zh) |
DE (1) | DE3675490D1 (zh) |
DK (1) | DK164584C (zh) |
ES (1) | ES8900091A1 (zh) |
FR (1) | FR2587977B1 (zh) |
GB (1) | GB2180815B (zh) |
IT (1) | IT1204329B (zh) |
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-
1985
- 1985-09-27 JP JP60214350A patent/JPS6274364A/ja active Granted
-
1986
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- 1986-04-17 DE DE8686105351T patent/DE3675490D1/de not_active Expired - Lifetime
- 1986-04-18 SE SE8601776A patent/SE500074C2/sv not_active IP Right Cessation
- 1986-04-22 FR FR8605811A patent/FR2587977B1/fr not_active Expired
- 1986-04-22 DK DK184286A patent/DK164584C/da not_active IP Right Cessation
- 1986-04-22 GB GB8609738A patent/GB2180815B/en not_active Expired
- 1986-04-23 ES ES554273A patent/ES8900091A1/es not_active Expired
- 1986-04-30 IT IT20275/86A patent/IT1204329B/it active
- 1986-05-21 CN CN86103457A patent/CN1014863B/zh not_active Expired
-
1987
- 1987-10-01 US US07/105,463 patent/US4813210A/en not_active Expired - Lifetime
Cited By (1)
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CN107921154A (zh) * | 2015-05-27 | 2018-04-17 | 贝克顿·迪金森公司 | 能使医疗装置再消毒的包装方法 |
Also Published As
Publication number | Publication date |
---|---|
DK164584B (da) | 1992-07-20 |
JPH0470023B2 (zh) | 1992-11-09 |
IT8620275A0 (it) | 1986-04-30 |
SE500074C2 (sv) | 1994-04-11 |
EP0218003B1 (en) | 1990-11-07 |
GB2180815B (en) | 1989-10-18 |
FR2587977A1 (fr) | 1987-04-03 |
DE3675490D1 (de) | 1990-12-13 |
ES8900091A1 (es) | 1988-12-01 |
ES554273A0 (es) | 1988-12-01 |
CN1014863B (zh) | 1991-11-27 |
SE8601776L (sv) | 1987-03-28 |
DK164584C (da) | 1992-12-14 |
US4813210A (en) | 1989-03-21 |
IT1204329B (it) | 1989-03-01 |
JPS6274364A (ja) | 1987-04-06 |
FR2587977B1 (fr) | 1988-12-02 |
GB2180815A (en) | 1987-04-08 |
GB8609738D0 (en) | 1986-05-29 |
SE8601776D0 (sv) | 1986-04-18 |
DK184286A (da) | 1987-03-28 |
EP0218003A1 (en) | 1987-04-15 |
DK184286D0 (da) | 1986-04-22 |
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