CN101600411B - 用于一容纳药液用的容器的封闭盖和用于容纳药液的容器 - Google Patents
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Abstract
本发明涉及一种用于一容纳药液用的容器、特别是按照吹-灌-封工艺制造的BFS瓶的封闭盖以及一种具有这种封闭盖的BFS容器。本发明的封闭盖(1)具有盖部(2)和边缘部(3),其中在盖部中设置有注射部(A)。该注射部(A)具有指向外部的连接部(6)和指向内部的封闭部(14),所述连接部(6)具有用于密封地接纳无针注射器的锥形杆的锥形凹部(7),所述封闭部(14)具有用于封闭所述连接部的所述凹部(7)的自密封膜片(16),该自密封膜片开有狭缝。本发明的封闭盖使得能够不使用注射针地注射液体。
Description
技术领域
本发明涉及一种用于一容纳药液用的容器、特别是输液容器或点滴容器的封闭盖,该封闭盖具有盖部和边缘部。此外,本发明还涉及一种具有这种封闭盖的用于容纳药液的容器、特别是BFS容器。
背景技术
已知一种吹-灌-封工艺(BFS工艺),其中,将容器——例如由挤出的PE或PP制成的瓶子——在单个工作过程中消过毒地且无热原地吹制成希望的形状,并直接在冷却后用消过毒的灌装物无菌地灌装,然后密封地封闭。所述按照吹-灌-封工艺制造的容器、特别是瓶子也被称作BFS容器。
当已知的BFS容器用于容纳消过毒的药液、例如输注液时,该容器需要允许输注液借助输注器具输送给患者的封闭盖系统。同样也应该能实现将药物添加到该输注液中。
由WO 96/23545中已知一种具有注射部和取出部的输注袋。取出部用于借助针尖取出输注液,注射部用于借助具有细针的注射器输入药物。注射部包括管状的连接部,该连接部由构造成断折部的保护盖封闭。在连接部中设置有由注射器的针刺穿的自密封膜片(隔膜)。连接部中的一可刺穿膜片防止在注射袋被使用之前所述隔膜与注射液相接触。取出部不具有自密封隔膜。由WO 96/23545已知的注射部和取出部用于焊接在注射袋内。
在实践中,已知的注射部已被证实是令人满意的。然而,在使用注射针来注射活性剂时出现缺点。一方面,存在注射针和隔膜之间的连接由于无意地拉拔注射器或由于注射袋内部的过压而松脱的风险。另一方面,注射针增加了医护人员受伤的风险。在操作不熟练时,其内焊接有注射部的注射袋也可能由于针而被损坏。此外,由于针的横截面积小,粘稠的活性剂的输入也较困难。另外,由于针的横截面积小,稀薄的活性剂的输入也需要较多的时间。
为了连接医疗仪器,在医药工程技术中已知具有锥形杆和锥形套的锥形连接件,其锥面是标准化的。具有标准化锥面的不可锁定的锥形连接器被称作鲁尔型连接器,可锁定的锥形连接器被称作鲁尔锁定型连接器。具有锥形杆的鲁尔型连接器或鲁尔锁定型连接器被称作雄连接器,具有锥形套的连接器被称作雌连接器。
DE 103 48 016 A1描述了一种焊接在注射袋内的连接器,该连接器使得能够借助常规的不具有注射针的鲁尔锁定型注射器注射活性剂。已知的连接器具有连接部,该连接部具有通道形式的凹部,在该凹部中设置有自密封膜片。所述通道形式的凹部由与所述连接部相连接的断折部封闭。在膜片上方,连接部构造成带有内锥面和外螺纹的连接件,其中,膜片开有狭缝以密封地接纳注射器的锥形杆。所述连接器由上部件和下部件组成,所述自密封膜片被夹紧地保持在上部件和下部件之间。
由DE 20 2004 003 267 U1中已知一种用于BFS容器的封闭盖,该封闭盖具有盖部和边缘部,其中在盖部中插有开有狭缝的膜片,该膜片使得输注器具的针尖能够插入。开有狭缝的膜片坐靠在封闭盖的盖部中并与之齐平。
发明内容
本发明的目的在于,提供一种用于一容纳药液用的容器、特别是BFS容器的封闭盖,该封闭盖使得能够不使用注射针地注射液体。此外,本发明的目的还在于,提供一种用于容纳药液的容器、特别是BFS容器,该容器使得能够不使用注射针地注射液体。
根据本发明,所述目的通过权利要求1和16中所述的特征来实现。本发明的优选实施例形成从属权利要求的主题。
根据本发明的用于一容纳药液用的容器、特别是一容纳输注液用的BFS容器的封闭盖具有盖部和边缘部,其中,在盖部中设置有用于注射药液的注射部。
所述注射部具有指向外部的连接部和指向内部的封闭部,所述连接部具有用于密封地接纳无针注射器的锥形杆的锥形凹部,所述封闭部具有用于封闭所述连接部的所述凹部的自密封膜片。所述自密封膜片开有狭缝,从而能够容易地插入注射器的锥形杆。
优点在于,除自密封膜片外,本发明的封闭盖设计成一件式的。由此能以低成本大批量地制造所述封闭盖。
在封闭盖的一个优选实施例中,注射部的封闭部具有一凹部,所述自密封膜片卡扣地插在所述凹部中。所述自密封膜片优选由封闭部的向内突出的边缘夹紧地固定在该凹部中。但是,除了在封闭部的整个周向边缘上延伸的、向内突出的边缘外,封闭部也可具有沿周向边缘分布地设置的钩状物,以夹紧地固定自密封膜片。
在本发明的更优选的实施例中,封闭部的凹部具有连接着盖部的第一柱形段和连接着该第一柱形段的第二柱形段,其中,第一柱形段具有比第二柱形段小的内径。
根据封闭盖的一个优选实施例,自密封膜片具有一环形段和一通过中间桥接段连接在该环形段上的碟形段,该环形段布置在凹部的具有较大内径的第二柱形段中,该碟形段布置在具有较小内径的第一柱形段中。由此自密封膜片能够可靠地保持在封闭部的凹部中。
自密封膜片的碟形段优选具有一碗形凹陷部。该碗形凹陷部一方面保证注射器的锥形杆被可靠地引导,另一方面确保膜片在抽出锥形杆后被可靠地密封。试验发现,膜片的特殊构型对于立即再封闭很关键,随着容器中的内压增加,膜片的密封还会增强。
在一个特别优选的实施例中,注射部的具有自密封膜片的封闭部设计成:当插入注射器的锥形杆时,膜片在凹部中被沿轴向压紧。由此,在插入锥形杆时,膜片打开。自密封膜片一方面充分地固定在封闭部的凹部中,而另一方面可自由移动,以便膜片在插入锥形杆时能沿轴向被压紧。在发生这种情况时,膜片的高度减小,即膜片的上侧不再与封闭部的凹部的贴合面相接触。
注射部的封闭部可设计成用于鲁尔型注射器或者用于鲁尔锁定型注射器。注射部的连接部优选具有外螺纹,从而能实现与注射器的鲁尔锁定型连接。
为了无菌地封闭自密封膜片,连接部优选由断折部封闭,该断折部通过环形断裂区连接在该连接部的上端部上。在断折部折断后,自密封膜片被暴露出来,从而能够插入注射器的锥形杆。
为了改善操作,断折部优选具有一侧向抓取翼,该抓取翼延伸到封闭盖的盖部的边缘部分。
除注射部以外,根据本发明的封闭盖还可具有用于通过尖状物取出药液的取出部。取出部优选也具有指向外部的连接部和指向内部的封闭部,该连接部具有凹部,尖状物被插入该凹部中,该封闭部由一可刺穿膜片封闭。
所述可刺穿膜片卡扣地插在取出部的封闭部的一凹部中。该膜片优选由封闭部的向内突出的边缘夹紧地固定。取出部的连接部也优选由一断折部封闭,该断折部通过环形断裂区连接在连接部的上端部上。取出部的断折部也优选具有侧向抓取翼,该抓取翼延伸到盖部的边缘部分。
根据本发明的容器、特别是优选构造成瓶子的输注容器或点滴容器由上述封闭盖封闭。
附图说明
下面参照附图详细阐述本发明的实施例。在附图中:
图1示出根据本发明的封闭盖的实施例;
图2是图1的封闭盖的侧视图;
图3是图1所示的封闭盖沿线III-III的剖面放大图;
图4a和图4b示出插入注射器的锥形杆之前和之后的封闭盖;
图4c是图4b的局部放大图;
图5是图1所示的封闭盖的剖视图;以及
图6示出具有本发明封闭盖的本发明容器的实施例。
具体实施方式
图1和图2是根据本发明的封闭盖的正投影视图,该封闭盖具有一注射部A和一取出部B。除自密封的或者说可刺穿的膜片外,封闭盖是一件式的塑料件,该塑料件可大批量地经济地制造。
封闭盖1具有一盖部2和一边缘部3。盖部2具有外部段4和向外突出的内部段(中间段)5。用于插入无针注射器的锥形杆的连接部6(图3)从该向外突出的内部段5指向外部。连接部6具有锥形凹部7和外螺纹8,所述锥形凹部7用于密封地接纳注射器的锥形杆。锥形凹部7和外螺纹8设计成使得一标准的商用鲁尔锁定型注射器可连接在该连接部上。
连接部6由一断折部9封闭,该断折部通过一环形断裂区10连接在该连接部的上端部上。断折部9具有一圆形的盖帽11,在该盖帽上通过窄的桥接部12连接有侧向抓取翼13,该抓取翼向下延伸到盖部的边缘部分。抓取翼13设计成其在侧向不延伸超过封闭盖。
具有一凹部15的封闭部14从盖部2的中间段5指向内部。在封闭部14的凹部15中插有自密封膜片16,该膜片卡扣地坐靠在所述凹部中。
封闭部14的凹部15具有连接在盖部2的中间段5上的上柱形段17。该上柱形段17连接着下柱形段18,该下柱形段18具有比上柱形段17大的内径。自密封膜片16相应地具有一具有较大外径的下部环形段19,该下部环形段19坐靠在凹部15的下柱形段18中。膜片16的下部环形段19通过中间桥接段20连接着具有较小外径的上部碟形段21,该上部碟形段21配合地坐靠在凹部15的上柱形段17中。封闭部具有向内突出的边缘35,该边缘夹紧地固定膜片16。膜片16的碟形段21具有一碗形的凹陷部22,该凹陷部22设有一个或多个狭缝23,例如十字形地裂开。
封闭盖1的边缘部3在其下部具有一隆起状边缘24,该边缘24在其下侧具有一环绕的凹槽25。封闭盖能套装在瓶子上,在这种情况下,瓶颈的上边缘接合在封闭盖的隆起状边缘24的凹槽25中。
下面参照图4a、4b和4c说明封闭盖的注射部A的工作方式。
为了用无针注射器注射液体例如药物,首先通过向侧面枢转抓取翼13使断折部9从连接部6断开。由此暴露出自密封膜片16。此后将无针注射器的锥形杆36插入连接部6的锥形凹部7中。之后将锥形杆36压到自密封膜片16的碟形段22上,由此使膜片被压紧(图4c)。由此膜片16的中间桥接段20被向内压,碟形段22在狭缝23的区域处被打开。现在就能注射药物了。
除注射部A之外,封闭盖还具有取出部B。注射部A和取出部B在封闭盖轴线的侧向并排地布置在封闭盖的盖部2的中间段5中。取出部B具有与注射部A相同的结构(图5)。
取出部B具有从盖部2的中间段5指向外部的连接部27,该连接部27具有用于插入输注器具的尖状物的凹部28。连接部27的凹部28由一断折部29封闭,该断折部29通过环形断裂区30连接在连接部的上端部上。断折部30也具有侧向抓取翼31,该抓取翼具有与注射部的断折部的抓取翼相同的结构。封闭部32从盖部2的中间段5向下指,在该封闭部32中夹紧地固定有由尖状物刺穿的膜片33。膜片33由封闭部32的向内突出的边缘34保持。在断折部29被折断后,膜片33被暴露出来并且被尖状物刺穿。利用所述尖状物就能取出液体了。
图6示出本发明的封闭盖和本发明的容器,该容器在本实施例中是BFS瓶子。
封闭盖1牢固地坐靠在瓶子38的瓶颈37上,该瓶子例如灌装有输注液。由于瓶颈在头部区域内未封闭,而是敞开的,因此液体直接与封闭盖相接触。因此可以用无针注射器注射药物。封闭盖优选构造成被旋到瓶颈37上的螺旋盖。但是,封闭盖也可以与瓶颈焊接在一起。
Claims (13)
1.一种用于一容纳药液用的容器的封闭盖,所述封闭盖具有盖部(2)和边缘部(3),其特征在于,在所述盖部(2)中设置有用于注射药液的注射部(A)和用于通过尖状物取出药液的取出部(B),其特征在于:
所述注射部(A)具有指向外部的连接部(6)和指向内部的封闭部(14),所述注射部(A)的所述连接部(6)具有用于密封地接纳无针注射器的锥形杆的锥形凹部(7),所述注射部(A)的所述封闭部(14)具有用于封闭所述注射部(A)的所述连接部的所述锥形凹部的自密封膜片(16),所述自密封膜片(16)开有狭缝;
所述注射部(A)的所述连接部(6)由一断折部(9)封闭,所述注射部(A)的所述断折部(9)通过一环形断裂区(10)连接在所述注射部(A)的所述连接部(6)的上端部上;
所述注射部(A)的所述断折部(9)具有一延伸到所述封闭盖的所述边缘部(3)的侧向抓取翼(13);
所述取出部(B)具有指向外部的连接部(27)和指向内部的封闭部(32),所述取出部(B)的所述连接部(27)具有用于接纳尖状物的凹部(28),所述取出部(B)的所述封闭部(32)具有用于封闭所述取出部(B)的所述连接部的所述凹部的可刺穿膜片(33);所述取出部(B)的所述连接部(27)由一断折部(29)封闭,所述取出部(B)的所述断折部(29)通过一环形断裂区(30)连接在所述取出部(B)的所述连接部的上端部上;所述取出部(B)的所述断折部(29)具有一延伸到所述封闭盖的所述边缘部(3)的侧向抓取翼(31)。
2.根据权利要求1所述的封闭盖,其特征在于,所述注射部(A)的所述封闭部(14)具有一凹部(15),所述自密封膜片(16)卡扣地插在所述注射部(A)的所述封闭部(14)的所述凹部(15)中。
3.根据权利要求1或2所述的封闭盖,其特征在于,所述注射部(A)的所述封闭部(14)具有向内突出的边缘(35),所述注射部(A)的所述封闭部(14)的所述边缘(35)将所述自密封膜片(16)夹紧地固定在所述注射部(A)的所述封闭部(14)的凹部(15)中。
4.根据权利要求1或2所述的封闭盖,其特征在于,所述注射部(A)的具有所述自密封膜片(16)的所述封闭部(14)设计成:当插入注射器的锥形杆时,所述自密封膜片在所述注射部(A)的所述封闭部(14)的凹部(15)中被沿轴向压紧,从而使得所述自密封膜片打开。
5.根据权利要求1或2所述的封闭盖,其特征在于,所述注射部(A)的所述封闭部(14)的凹部(15)具有连接着所述盖部(2)的第一柱形段(17)和连接着所述第一柱形段的第二柱形段(18),所述第二柱形段具有比所述第一柱形段大的内径。
6.根据权利要求5所述的封闭盖,其特征在于,所述自密封膜片(16)具有一环形段(19)和一通过中间桥接段(20)连接在所述环形段(19)上的碟形段(21),所述环形段(19)布置在所述第二柱形段(18)中,所述碟形段(21)布置在所述第一柱形段(17)中。
7.根据权利要求6所述的封闭盖,其特征在于,所述自密封膜片(16)的所述碟形段(21)具有一碗形凹陷部(22)。
8.根据权利要求1或2所述的封闭盖,其特征在于,所述注射部(A)的所述连接部(6)具有外螺纹(8)。
9.根据权利要求1或2所述的封闭盖,其特征在于,所述取出部(B)的所述可刺穿膜片(33)卡扣地插在所述取出部(B)的所述连接部(27)的所述凹部(28)中。
10.根据权利要求9所述的封闭盖,其特征在于,所述取出部(B)的所述封闭部(32)具有向内突出的边缘(34),所述取出部(B)的所述封闭部(32)的所述边缘(34)将所述可刺穿膜片(33)夹紧地固定在所述取出部(B)的所述连接部(27)的所述凹部(28)中。
11.根据权利要求1或2所述的封闭盖,其特征在于,所述容器是BFS容器。
12.一种具有根据权利要求1至11中任一项所述的封闭盖(1)的容器。
13.根据权利要求12所述的容器,其特征在于,所述容器是BFS瓶。
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- 2008-02-04 EP EP08707528.9A patent/EP2114345B1/de active Active
- 2008-02-04 AU AU2008213344A patent/AU2008213344B2/en active Active
- 2008-02-04 CA CA2677286A patent/CA2677286C/en active Active
- 2008-02-04 KR KR1020097016106A patent/KR101462198B1/ko active IP Right Grant
- 2008-02-04 BR BRPI0807070A patent/BRPI0807070B8/pt active IP Right Grant
- 2008-02-04 US US12/523,971 patent/US9095500B2/en active Active
- 2008-02-04 WO PCT/EP2008/000851 patent/WO2008095665A1/de active Application Filing
- 2008-02-04 MX MX2009008272A patent/MX2009008272A/es active IP Right Grant
- 2008-02-04 JP JP2009547612A patent/JP5563310B2/ja active Active
- 2008-02-04 CN CN200880003894.2A patent/CN101600411B/zh active Active
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Patent Citations (2)
Publication number | Priority date | Publication date | Assignee | Title |
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GB2089332A (en) * | 1980-10-14 | 1982-06-23 | Travenol Europ Res & Dev | Flexible tubular boot member for connection between a port of a container and a spike |
US6681946B1 (en) * | 1998-02-26 | 2004-01-27 | Becton, Dickinson And Company | Resealable medical transfer set |
Also Published As
Publication number | Publication date |
---|---|
CA2677286C (en) | 2015-04-07 |
KR101462198B1 (ko) | 2014-11-17 |
CN101600411A (zh) | 2009-12-09 |
EP2114345A1 (de) | 2009-11-11 |
KR20090113278A (ko) | 2009-10-29 |
US9095500B2 (en) | 2015-08-04 |
ZA200904680B (en) | 2010-04-28 |
BRPI0807070B8 (pt) | 2021-06-22 |
AU2008213344B2 (en) | 2013-08-29 |
DE102007005407A1 (de) | 2008-08-07 |
CA2677286A1 (en) | 2008-08-14 |
WO2008095665A1 (de) | 2008-08-14 |
AU2008213344A1 (en) | 2008-08-14 |
EP2114345B1 (de) | 2016-12-07 |
BRPI0807070B1 (pt) | 2018-10-02 |
BRPI0807070A2 (pt) | 2014-04-08 |
JP5563310B2 (ja) | 2014-07-30 |
JP2010517607A (ja) | 2010-05-27 |
MX2009008272A (es) | 2009-08-12 |
US20100059474A1 (en) | 2010-03-11 |
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