CN105939697A - 用于可流体化物质的容器的进入装置 - Google Patents
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Abstract
用于可流体化物质的容器的进入装置包括:主体(1),其设有中空尖状物(4),该中空尖状物被设计成插入到待流体化的物质的容器(F)中并具有轴向流体通道(5)和用于对容器(F)进行通气的轴向通道(6);能扩展室(14),其通过主体(1)的横向通道(7)连接到尖状物(4)的通气通道(6);第一止回阀(24),其实现从横向通道(7)到能扩展室(14)的单向连通;第二止回阀(23),其实现从通气开口(25)到尖状物(4)的通气通道(6)的单向连通。双层不能渗透过滤膜(22a、22b)被插入在第一止回阀(24)和第二止回阀(23)之间。
Description
技术领域
本发明涉及一种用于待流体化的物质的容器的进入装置,所述容器例如容纳粉末状药物(诸如,在化疗等等期间给予的类型的抗生素和毒性药品)的小瓶。
背景技术
在专利US-7,743,799(申请人为该专利的所有者)中,已知一种进入装置,其包括主体,所述主体设有中空尖状物,所述中空尖状物被设计成插入到可流体化物质的容器中并具有轴向流体通道和用于对容器进行通气的轴向通道。能扩展室通过主体的横向通道连接到尖状物的通气通道,并且该装置还包括:第一止回阀,其实现从横向通道到能扩展室的单向连通;以及第二止回阀,其实现从通气开口到尖状物的通气通道的单向连通。
此类装置被用来(例如)向小瓶中所容纳的干性药用物质添加稀释液体,以允许例如借助于输液袋将因此流体化的药用物质从小瓶随后转移到患者。
在通过尖状物(通常以可密封方式被插入通过小瓶的可刺破弹性帽)的流体通道将液体引入到小瓶中期间,由药用物质在其被稀释后产生的气相在压力下通过主体的横向通道和第一单向止回阀被输送到能扩展室中并被捕获于其中。以此方式,这些气相并未污染周围空气,因此防止吸入及在对他/她的健康有相关风险的情况下防止与操纵进入装置的操作者接触。
当通过尖状物的流体通道抽吸从小瓶提取药用物质(已照此稀释的)时,第二单向止回阀使得能够重新平衡小瓶内的压力。
在根据文献US-7,743,799的进入装置的第一实施例中,相应的过滤器被布置在两个止回阀中的每个的上游。在文献US-7,743,799中示例性的其它实施例中,替代地设置由液体不能渗透材料形成的单个过滤膜。这个不能渗透过滤膜被布置成与尖状物同轴并形成有以可密封方式由尖状物自身越过的中心孔。第一和第二止回阀相对于这个不能渗透过滤膜位于同一侧上,所述不能渗透过滤膜实施双重功能: 其过滤通过第二止回阀引入到小瓶中的空气,并构成屏障,其防止液体(更确切地说,稀释的药用物质)通过第一止回阀进入能扩展室内。
文献US-8,523,838中描述了类似的解决方案,其中,两个单向止回阀均布置在主体的横向通道中,在这种情况下也是相对于不能渗透过滤膜位于同一侧上,所述不能渗透过滤膜直接被应用在能扩展室的入口处。在稀释的药用物质的提取步骤期间对小瓶进行通气因此使用了能扩展室内所容纳的受污染大气,这可能导致诸多问题。此外,虽然此文献包括两个单向阀的特定打开压力,但可能已经穿透到能扩展室中的雾化药物的颗粒仍能够阻塞过滤膜,并阻止或至少不可接受地减少小瓶的通气流动,由此难以从小瓶提取药用物质。
在文献WO-2013/025946的情况下,同样设有两个止回阀,且过滤器定位在两个止回阀和尖状物的通气通道之间。
发明内容
本发明旨在消除上述缺陷并完善上文所引用的文献US-7,743,799中描述并说明的进入装置,并且还涉及改进安全性,以防在使用所述装置期间从小瓶提取的药用物质发生环境散布的风险。
根据本发明,这个目标主要借助于如权利要求1的预特征部分中所限定的进入装置来实现,所述进入装置的特征在于:所述不能渗透过滤膜器件被插入在所述第一和第二止回阀之间。
由于这个解决方案构想,使得不能渗透过滤膜器件不仅实施过滤小瓶的排出空气并阻隔在稀释的药用物质的能扩展室内的入口的功能,而且还能够在第一止回阀以及可能地第二止回阀也发生故障或无效关闭的情况下针对药用物质的逃逸的雾化颗粒(其也许可能已经进入到能扩展室中)提供更有效的屏障。实际上,在此类可能发生的事中,不能渗透过滤膜器件有利地使得能够阻止雾化颗粒从能扩展室的回流,在第一止回阀的下游及第二止回阀的上游两者,因此将这些颗粒安全地隔离在能扩展室内。
根据本发明的优选实施例,设置彼此平行且邻近的两个不能渗透过滤膜,以便界定与中空尖状物的所述通气通道连通的中间室。
能扩展室以已知方式包括容纳壳体,在所述容纳壳体内柔性膜的周边边缘被固定:根据本发明的另外的有利特征,这个柔性膜在容纳壳体内重叠注塑。相比于在上述文献US-7,743,799中所描述的,其中,单独地生产柔性膜且然后通过胶合或焊接将柔性膜接合到容纳壳体,这允许简化进入装置的制造方法。
附图说明
现将参考纯粹通过非限制性示例提供的附图来详细描述本发明,在附图中:
-图1是表示处于第一操作状态的根据本发明的实施例的进入装置的示意性透视图,
-图2是示出装置处于第二操作状态的与图1类似的视图,以及
-图3是图1的垂直横截面局部视图。
具体实施方式
参考图,根据本发明的用于药用物质的容器的进入装置包括:模制塑料材料的主体(一般由1指示),该主体包括凸缘2,在该凸缘的顶部上伸出例如鲁尔接头或鲁尔接头锁类型的管状连接器3,且在该凸缘下面中空尖状物4与管状连接器3同轴延伸。
如图3中可见,中空尖状物4具有两个并排的轴向通道:流体通道5,其在顶部与管状连接器3连通;以及通气通道6,其与横向通道7连通。
具有弹性可变形部分的环形裙状物8在凸缘2下面延伸,所述环形裙状物被构造成用于接合小瓶F(例如,容纳意欲以下文所解释的方式被流体化并被给予的干性粉末(例如,药物))的形状互补的颈部。当环形裙状物8装配在小瓶F的颈部上时,如图1和图2中所示,小瓶F以常规方式借助于可由尖状物4刺破的弹性材料的帽T被密封住。
管状连接器3进而被构造成与例如阀类型的连接器C联接,所述连接器C由申请人按名称“B-Site”来制造和销售。
横向通道7能够与主体1整体形成,或如在所说明的示例的情况下,其能够为横向地固定到主体1的独立中间元件(由12指示)的一部分。中间元件12形成有外部径向凸缘9且在内部形成有环形壁10。
凸缘9固定到能扩展室的互补凸缘13,能扩展室整体上由14指示且包括杯状半壳15,其周边边缘在与凸缘13相对的侧部处固定到与半壳15共模制的柔性膜19的周边边缘18的保持环16并就此界定能扩展室14的容积。图1和图3示出最小体积的状态,其中,柔性膜19缩在半壳15内;同时图2示出最大体积的状态,其中,膜19在半壳15的外部延伸。应注意,具有相关凸缘13的能扩展室14可应用于不同形式的主体1。
从半壳15朝中间元件12轴向地伸出的凸缘13在内部由曲径壁20形成,所述曲径壁具有用于与能扩展室14的内部连通的中心通孔21。由液体不能渗透材料的盘状物形成的第一过滤膜22a被固定到该壁20,并使涂覆有热塑性材料的面焊接到壁20。
类似地由液体不能渗透材料的盘状物形成的第二过滤膜22b使涂覆有热塑性材料的面焊接到环形壁10。
两个膜22a和22b彼此平行且稍微隔开,以便界定中间室26,所述中间室通过受限制通道27和中间元件12的横向通道7与尖状物4的通气通道6连通。
数字23和24分别指示两个单向止回阀,一个与居中地形成在中间元件12中的通气开口25操作性地相关联,且另一个与壁20的通孔21相关联。
止回阀24(在下文中将其指示为第一止回阀)使得通过横向通道7、受限制通道27、室26、过滤膜22a和孔21实现从尖状物4的轴向通气通道6到能扩展室14的单向连通。
止回阀23(在下文中将其指示为第二止回阀)使得通过第二过滤膜22b、室26、受限制通道27和横向通道7实现通气开口25和尖状物4的通气通道6之间的单向连通。
就上述的独特布置而言,双层不能渗透过滤膜22a、22b因此插入在止回阀23和24之间,从而允许保证改进根据本发明的进入装置的操作安全性,所述进入装置的操作如下。
首先,容纳有干性物质(例如,药粉或颗粒)的小瓶F通过接合凸缘8联接到主体2,以便由尖状物4刺破帽T。接着,由于与管状连接器C相联接,所以液体被引入到小瓶F内以实现药用物质的稀释和流体化。液体(例如)借助于联接到管状连接器C的注射器被引入,并通过尖状物4的流体通道5穿透到小瓶F内。由药用物质在其稀释期间产生的气相被送入到尖状物4的通气通道6中,并穿过横向通道7、受限制通道27、室26、过滤膜22a和孔21。第一止回阀24打开,因此允许这些气相进入能扩展室14内。在这个步骤结束时,已越过过滤膜22a并且也可能已越过过滤膜22b的药用物质的任何雾化液滴由于止回阀23的关闭而被保留。
接着将进入装置倒置,以借助于通过尖状物4的流体通道5的抽吸来从小瓶F提取流体化的药用物质。如果在这个步骤错误地代替抽出,操作者将处于压力下的空气推入小瓶F中,那么通过尖状物4的通气通道6被推向能扩展室14的液体将遇到通过两个过滤膜22a、22b操作的屏障,而不能够到达能扩展室14,更不用说到达外部环境了。
当液体被正确抽出时,通过通气开口25和打开的止回阀23将补偿空气引入到小瓶F中。在这个步骤期间,来自通气开口25的空气通过膜22a被过滤,同时通过能扩展室14内的压力使阀24保持关闭。因此经过滤的空气接着通过室26、受限制通道27、横向通道7和尖状物4的通气通道6到达小瓶F的内部。因此,显然,将过滤膜22a放置在阀23和24之间允许获得对引入到小瓶F中的补偿空气的最佳过滤。
另外,根据本发明的不能渗透过滤膜22a、22b的独特布置还允许关于在止回阀24以及可能地止回阀23也发生故障的情况下由从小瓶F提取的流体化药用物质引起环境污染的风险的影响,进一步改进装置的操作安全性。事实上,在这种情况下,药用物质的雾化颗粒(可能已被捕获于能扩展室14内)将仍被过滤膜22a、22b阻止和保留,而不能够到达通气开口25。
另外的优点在于在使用不当从而导致在小瓶F内产生过压的情况下该装置的改进的操作安全性。事实上,在错误地迫使液体进入到小瓶F中同时保持该装置倒置(更确切地说,尖状物4面向上)的情况下,这种液体将通过通道6和受限制通道27到达室26,但在这种情况下将被过滤膜22b被阻止,而不能够到达通气开口25。
当然,在不脱离如由下述权利要求限定的本发明的范围的情况下,实施例的构造和形式的细节可关于所描述和说明的那些广泛地加以改变。
Claims (3)
1.一种用于可流体化物质的容器的进入装置,其包括:主体(1),所述主体设有中空尖状物(4),所述中空尖状物被设计成插入到待流体化的物质的容器(F)中并具有轴向流体通道(5)和用于对所述容器(F)进行通气的轴向通道(6);能扩展室(14),所述能扩展室通过所述主体(1)的横向通道(7)连接到所述尖状物(4)的所述通气通道(6);第一止回阀(24),所述第一止回阀实现从所述横向通道(7)到所述能扩展室(14)的单向连通;第二止回阀(23),所述第二止回阀实现从通气开口(25)到所述尖状物(4)的所述通气通道(6)的单向连通,并且其中,设有不能渗透过滤膜器件(22a、22b),所述不能渗透过滤膜器件防碍液体到所述能扩展室(14)中的入口并且防止从所述通气开口(25)损失液体,其特征在于:所述不能渗透过滤膜器件(22a、22b)被插入在所述第一止回阀(24)和所述第二止回阀(23)之间。
2.根据权利要求1所述的进入装置,其特征在于:所述装置包括彼此平行且邻近的两个不能渗透过滤膜(22a、22b),以便界定与所述尖状物(4)的所述通气通道(6)连通的中间室(26)。
3.根据权利要求1或2中的任一项所述的进入装置,其中,所述能扩展室(14)包括半壳壳体(15)和固定到所述壳体(15)的柔性膜(19),其特征在于:所述柔性膜(19)被共模制到所述壳体(15)。
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CN105939697B (zh) | 2019-07-16 |
HRP20180140T1 (hr) | 2018-03-09 |
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