CN111295171A - 包括双排气母瓶适配器的双瓶适配器组件 - Google Patents

包括双排气母瓶适配器的双瓶适配器组件 Download PDF

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CN111295171A
CN111295171A CN201880070911.8A CN201880070911A CN111295171A CN 111295171 A CN111295171 A CN 111295171A CN 201880070911 A CN201880070911 A CN 201880070911A CN 111295171 A CN111295171 A CN 111295171A
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伊戈尔·登堡
阿米尔·列夫
乌里·大卫
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Abstract

双瓶适配器组件，具有如下三组件结构：用于在药瓶上伸缩安装的第一排气母瓶适配器，用于在液体瓶上伸缩安装的第二排气母瓶适配器，以及用于耦合第一排气母瓶适配器和第二排气母瓶适配器的管状液体传输耦合器，以在两者之间建立双密封腔设置。双密封腔设置包括中心密封液腔和密封气腔，中心密封液腔用于将液态成分从液体瓶重力流至药瓶，密封气腔从中心密封液腔径向向外，以将气体从药瓶排出至液体瓶，从而通过在液体瓶和药瓶之间建立封闭系统来协助液态成分的重力流动。

Description

包括双排气母瓶适配器的双瓶适配器组件
技术领域
本发明涉及用于含有药物的药瓶和含有液态成分的液体瓶的双瓶适配器组件。
背景技术
双瓶适配器组件用于与包含药物的药瓶和包含液态成分的液体瓶仪器一起使用，以与药瓶中的药物混合或重组以形成液体药物，双瓶适配器组件包括药瓶适配器和液体瓶适配器，药瓶适配器用于在药瓶上伸缩安装以穿刺药瓶，液体瓶适配器用于伸缩安装在液体瓶上用于穿刺液体瓶。双瓶适配器组件能够大致分为如下两大类：负压型，与药瓶在负压下一起使用，以将液体瓶中的液态成分正吸入药瓶中。重力流动型，采用排气装置，以将液态成分通过重力流动从液体瓶流至药瓶。前一类型需要先在液体瓶上进行套管式装配，随后在药瓶上进行套管式装配，并且通常用于制备小剂量液体药物。后一类型不需要在液体瓶和药瓶上按特定顺序进行套管式装配，通常用于制备适合吸入多种液体药物剂量的大量液体药物或与静脉输液器(IV set for infusion)使用。
Denenburg所拥有的题发明名称为“液体药物转移装置”的美国专利8,952,598公开了一种重力型示范性双瓶适配器组合。该美国专利598图9示出了用于穿刺液体瓶塞和药瓶塞的双瓶适配器装置，其包括具有母连接件(female connector)的药瓶适配器和具有双腔双端液体输送钉(dual lumen dual ended liquid transfer spike)的液体适配器。用户必须正确区分药瓶适配器和液体瓶适配器，以便于能够在药瓶中形成液体药物，从而能够将无针注射器连接到药瓶适配器，以便从中抽吸液体药物。但是，药瓶适配器和液体瓶适配器高度相似，这可能导致两者之间混淆，从而导致液体药物在液体瓶中形成，进而不能将无针注射器连接到具有双腔双端液体输送钉的药瓶适配器。
此外，发明名称为“包括排气药瓶适配器和排气液体瓶适配器的双瓶适配器组件”、PCT国际申请号为PCT/IL2017/050527、公开号为WO2017/203512公开了另一种双瓶适配器组件，如下：图1至图5公开了排气母药瓶适配器(vented female drug vial adapter)和排气公液体瓶适配器(vented male liquid vial adapter)；图6至图8公开了相同的双排气母瓶适配器和过渡双端液体传输耦合器，该耦合器具有一对相对的公连接件。图9至图11公开了相同的双排气公瓶适配器和过渡双端液体传输耦合器，该耦合器具有一对相对的母连接件。双瓶适配器组件具有相同的双排气瓶适配器，具有以下优点，排气瓶适配器能够相等地可伸缩地安装于药瓶或液体瓶，从而不需要用户区分药瓶适配器和液体瓶适配器。排气瓶适配器优选地设计为从瓶中快速释放，如发明名称为“瓶适配器”的PCT国际申请WO2012/150587中所公开的。因此，可以容易地从含有液体药物的药瓶移除排气药瓶适配器，从而暴露其药瓶塞以插入用于向患者输注液体药物的静脉注射器。
需要双瓶适配器组件以改善从液体瓶至药瓶的重力流动，以在药瓶中形成液体药物成分。
发明内容
本发明涉及有以下三组件结构的双瓶适配器组件：用于在药瓶上伸缩安装的第一排气母瓶适配器，用于在液体瓶上伸缩安装的第二排气母瓶适配器，以及用于耦合第一排气母瓶适配器和第二排气母瓶适配器的管状液体传输耦合器，以在两者之间建立双密封腔设置。双密封腔设置包括中心密封液腔和至少一个密封气腔，中心密封液腔用于当将液体瓶放置高于药瓶时，将液态成分从液态瓶重力流至药瓶，密封气腔从中心密封液腔径向向外，以将气体从药瓶排至液体瓶，从而通过在液体瓶和药瓶之间建立密闭系统来协助液态成分的重力流动。液体传输耦合器优选地设计为使密封气腔优选地围绕中心密封液腔，并且与之同心。本发明的双瓶适配器组件优选地设置在开始位置，以便从合适的无菌包装中取出后立即使用。或者，双瓶适配器组件可在使用前要求用户进行组装。
附图说明
为了理解本发明，并且了解如何在实践中实施本发明，现将参考附图用来描述优选实施例，附图中类似部分的编号相同，并且其中：
图1为根据本发明第一优选实施例的给药装置示意图，该给药装置包括：无针注射器、药瓶、液体瓶、输液装置和双瓶适配器组件；
图2为图1中双瓶适配器组件的爆炸图；
图3为图1双瓶适配器组件沿图1中A-A线的纵截面图；
图4为图1双瓶适配器组件沿图1中A-A线的纵截面图，其示出了液态成分从液体瓶输送至药瓶，以及气从药瓶传排出液体瓶；
图5A至图5F示出给药装置的使用；
图6为根据本发明第二优选实施例的双瓶适配器组件的透视图；
图7为图6双瓶适配器组件的爆炸图；
图8A为图6双瓶适配器组件的液体传输耦合器的俯视图；
图8B为图6液体传输耦合器沿图8A中C-C线的纵截面图；
图8C为图6液体传输耦合器沿图8A中D-D线的纵截面图；以及
图9为图6双瓶适配器组件沿图8A中D-D线的纵截面图。
具体实施方式
图1示出了给药装置5，其包括最初为空的无针注射器10、药瓶20、液体瓶30、输液装置40(以缩小的比例示出)以及双瓶适配器组件100。无针注射器10包括桶11、柱塞12和公鲁尔锁连接件(male Luer lock connector)13。注射器10能够与其他类型的母连接件成型。药瓶20具有纵向药瓶轴20A且包括开盖药瓶体(open topped drug vial bottle)21，该药瓶体具有药瓶冠(drug vial crown)22和窄径药瓶颈23。药瓶冠22由药瓶塞24密封。药瓶塞24通过铝带26密封。药瓶20包含药物27，药物为粉末、固体或液体形式。液体瓶30具有纵向液体瓶轴30A并且包括开盖液体瓶体31，该瓶体具有液体瓶冠32和窄颈药瓶颈33。液体瓶冠32由液体瓶塞34密封，液体瓶塞34由铝带36密封。液体瓶30包括仅以稀释剂或活性成分形式存在的液态成分37。静脉注射器40包括静脉钉(IV spike)41、第一管42、卡箍43、滴注室44、第二管46、滚柱卡箍47、公鲁尔连接件48和鲁尔护罩49。第一管42的尺寸通常为4.1mm×200mm，第二管46的尺寸通常为4.1mm×500mm。
图2至图4示出了双瓶适配组件100具有纵向双瓶适配器组件中心线101，并且包括三部分结构，其包括用于伸缩安装在药瓶20上的第一排气母瓶适配器110，用于伸缩安装在液体瓶30上的第二排气母瓶适配器120，以及用于与第一排气母瓶适配器110和第二排气母瓶适配器120耦合的管状液体传输耦合器130。
第一排气母瓶适配器110具有纵向第一排气母瓶适配器中心线111，并且包括横向第一排气母瓶适配器上壁112，该横向第一排气母瓶适配器上壁112具有竖直第一排气母瓶适配器母连接件113和第一排气母瓶适配器上壁排气口112A的直径对第一排气母瓶适配器上壁排气口112A的直径对从竖直第一排气母瓶适配器母连接件113相对于纵向第一排气母瓶适配器中心线111径向向外。竖直第一排气母瓶适配器母连接件113优选地由母鲁尔连接件构成，该连接件包括用于螺纹连接公鲁尔锁连接件的外螺纹。第一排气母瓶适配器110包括第一排气母瓶适配器裙板114，其用于伸缩安装于药瓶20上，以及设置在横向第一排气母瓶适配器上壁112和第一排气母瓶适配器裙板114之间的环形气体过滤腔116。环形气体过滤腔116包括环形气体过滤器116A。
第一排气母瓶适配器上壁112包括内部环形围绕物117，该环形围绕物从第一排气母瓶适配器上壁排气口112A的直径对相对于纵向第一排气母瓶适配器中心线111径向向外。第一排气母瓶适配器上壁112包括围绕内部环形围绕物117的外部环形围绕物118，并且在其附近用于限定其中的环形槽。内部环形围绕物117具有面向外部环形围绕物118的外周密封面117A。外部环形围绕物118包括相对的一对用于接合的接合槽118A。内部围绕物117和外部围绕物118不一定是环形的，但一定是相对于纵向第一排气母瓶适配器中心线111从第一排气母瓶适配器上壁通风口112A径向向外。
第一排气母瓶适配器裙板114包括第一双腔瓶塞穿刺套管119，用于在将第一排气管母瓶适配器110伸缩地安装在药瓶20上时刺穿药瓶塞24。第一双腔瓶塞穿刺套管119包括与第一排气母瓶适配器连接件113流动连通的液腔119A和与排气母瓶适配器上壁通风口112A的直径对流动连通的气腔119B。
第二排气母瓶适配器120具有纵向第二排气母瓶适配器中心线121，并且包括横向第二排气母瓶适配器上壁122，横向第二排气母瓶适配器上壁122具有竖直第二排气母瓶适配器母连接件123和第二排气母瓶适配器上壁排气口122A的直径对，第二排气母瓶适配器上壁排气口122A的直径对从竖直第二排气母瓶适配器母连接件123相对于纵向第二排气母瓶适配器中心线121径向向外竖直第二排气母瓶适配器母连接件123优选地由母鲁尔连接件构成，该母鲁尔连接件包括用于由公鲁尔锁连接件螺纹接合的外螺纹。第二排气母瓶适配器120包括用于液体瓶30上伸缩安装的第二排气母瓶适配器裙板124和设置在横向第二排气母瓶适配器上壁122和第二排气母瓶适配器裙板124之间的环形气体过滤腔126。环形气体过滤腔126包括环形气体过滤器126A。
第二排气母瓶适配器上壁122包括内部环形围绕物127，其相对于纵向第二排气母瓶适配器中心线121从第二排气母瓶适配器上壁排气口122A的直径对径向向外的，并围绕竖直的第二排气母瓶适配器母连接件123。第二排气母瓶适配器上壁122包括围绕内部环形围绕物127的外部环形围绕物128，并且在其附近用于限定其中的环形槽。内部环形围绕物127具有面向外部环形围绕物128的外周密封面127A。外部环形围绕物128包括一对相对的接合槽128A。内部环形127和外部环形128不一定是环形的，但一定是相对于纵向第一排气母瓶适配器中心线121从第一排气母瓶适配器上壁通风口122A径向向外。
第二排气母瓶适配器裙板124包括第二双腔瓶塞穿刺套管129，用于在将第二排气管母瓶适配器120伸缩地安装在液体瓶30上时刺穿液体瓶塞34。。第二双腔瓶塞穿刺套管129包括与第二排气母瓶适配器连接件123流动连通的液腔129A和与排气母瓶适配器上壁排气口112A直径对流动连通的气腔129B。
第一排气母瓶适配器110和第二排气母瓶适配器120优选为发明名称为“瓶适配器”、公开号为WO2012/150587的PCT国际申请中公开的快速释放型。
液体传输耦合器130具有纵向液体传输耦合器中心线131，并且包括第一液体传输耦合器端130A和第二液体传输耦合器端130B，在双瓶适配器组件100的开始位置，第一液体传输耦合器端130A用于接合第一排气母瓶适配器110，第二液体传输耦合器端130B用于接合第二排气母瓶适配器120。液体传输耦合器130包括气腔壁132和外壁133，液体传输耦合器130通过径向叶片134安装于外壁133上。外壁133在横向第一排气母瓶适配器112和横向第二排气母瓶适配器上壁122的周长之间延伸，以协助操作双瓶适配器组件100。气腔壁132包括内部环形横向法兰136，该法兰具有竖直第一公连接件137A以及相对定向的第二公连接件137B，第一公连接件137A用于密封插入竖直第一排气母瓶适配器母连接件113，，第二公连接件137B用于密封插入竖直第二排气母瓶适配器母连接件123。
气腔壁132具有相对的一对径向向外定向的接合突起132A及相对的一对径向向外定向的接合突起132B(未示出)，突起132A用于与接合槽118A接合，位于液体传输耦合器端130A处，突起132B用于在双瓶适配器组件100的开始位置与接合槽128A接合，位于液体传输耦合器端130B处。在双瓶适配器组件100的开始位置，气腔壁132用于在第一液体传输耦合器端130A滑动插入内部环形围绕物117和外部环形围绕物118之间，以及在第二液体传输耦合器端130B滑动插入内部环形围绕物127和外部环形围绕物128之间。气腔壁132密封位于第一液体传输耦合器端130A处的外周密封面117A和位于第二液体传输耦合器端130B处的外周密封面127A。
在双瓶适配器组件100的设置位置，液体传输耦合器130同时建立双密封腔排布138，双密封腔排布138包括中央密封液腔138A和围绕液体腔138A的密封气腔138B，中央密封液腔138A在第一排气母瓶适配器母连接件113和第二排气母瓶适配器母连接件123之间，密封气腔138B用于密封在第一排气母瓶适配器上壁排气孔112A的直径对和第二排气母瓶适配器上壁排气孔122A的直径对之间的流动连通。因此双瓶适配器组件100在液体瓶和药瓶之间建立密封系统，用以协助液态成分从液体瓶重力流动至药瓶。图4示出了液态成分通过密封液腔138A从液体瓶30至药瓶20的重力流动，以及气体通过气腔119B、密封气腔138B和气腔129B从药瓶20至液体瓶30的排出，用箭头A表示重力流动，用箭头B表示排气。
图5A至图5F示出了给药装置5在准备向患者给药的药瓶20中制备液体药物的用途。图5A了示出将第二排气母瓶适配器120伸缩安装在液体瓶30上以穿刺液体瓶30。图5B示出了将双瓶适配器组件100与所附液体瓶30倒置，并将第一排气母瓶适配器110伸缩安装在药瓶20上以便穿刺药瓶20，从而使液态成分从液体瓶30向药瓶20重力流动，以在其中形成液体药物，并将气体从药瓶20中排出至液体瓶30。图5C示出了从第一排气母瓶适配器110上拧下液体传输耦合器130。图5D示出了将注射器10拧至第一排气母瓶适配器110上，以从药瓶20中抽出液体药物剂量供给药物给患者。图5E示出了从药瓶20上移除第一排气母瓶适配器110。图5F示出了静脉输液器40与药瓶20的连接，用于向患者输注液体药物。
图6至图9所示为双瓶适配器组件200，其结构与操作与双瓶适配器组件100相似。双瓶适配器组件200与双瓶适配器组件100的不同之处在于，液体传输耦合器130与第一排气母瓶适配器110和第二排气母瓶适配器120的结合。与相对的一对接合槽118A和向外定向的结合突起132A和相对的一对结合槽128A和向外定向的结合突起132B的设置相反，气腔壁132包括内部第一螺纹139A以及内部第二螺纹139B，内部第一螺纹139A用于接合第一排气母瓶适配器母连接件113，内部第二螺纹139B用于接合第二排气母瓶适配器母连接件123。
尽管已说明和描述了本发明的特定实施例，但对于本领域技术人员来说，显而易见的是，可以在不脱离本发明精神和范围的情况下进行各种其他改变和修改。

Claims (6)

1.一种与药瓶和液体瓶一起使用的双瓶适配器组件，所述药瓶具有药瓶体和密封所述药瓶体的药瓶塞，所述药瓶包含药物，所述液体瓶具有液体瓶体以及密封所述液体瓶体的液体瓶塞，所述液体瓶包含液态成分，所述液态成分用以与所述药瓶中的药物混合或重组，以在所述药瓶中形成液体药物，所述双瓶适配器组件具有纵向双瓶适配器组件中心线，并且包括：
(a)第一排气母瓶适配器，用于在所述药瓶上伸缩安装，所述第一排气母瓶适配器具有纵向第一排气母瓶适配器中心线，并且包括：
(i)横向第一排气母瓶适配器上壁，具有竖直第一排气母瓶适配器母连接件和至少一个第一排气母瓶适配器上壁排气口，所述第一排气母瓶适配器上壁排气口从所述竖直第一排气母瓶适配器母连接件相对于所述纵向第一排气母瓶适配器中心线径向向外，
(ii)第一排气母瓶适配器裙板，用于在所述药瓶上伸缩安装，以及
(iii)第一双腔瓶塞穿刺套管，用于在所述药瓶上伸缩安装所述第一排气母瓶适配器时，穿刺所述药瓶塞，所述第一双腔瓶塞穿刺构件包括与所述竖直第一排气母瓶适配器母连接件流动连通的第一液腔，以及与所述至少一个第一排气母瓶适配器上壁排气口流动连通的第一气腔；
(b)第二排气母瓶适配器，用于在所述液体瓶上伸缩安装，第二排气母瓶适配器具有纵向第二排气母瓶适配器中心线，并且包括：
(i)横向第二排气母瓶适配器上壁，具有竖直第二排气母瓶适配器母连接件，以及至少一个第二排气母瓶适配器上壁排气口，所述第二排气母瓶适配器上壁排气口从所述竖直第二排气母瓶适配器母连接件相对于所述纵向第二排气母瓶适配器中心线径向向外，
(ii)第二排气母瓶适配器裙板，用于在所述液体瓶上伸缩安装，以及
(iii)第二双腔瓶塞穿刺套管，用于在所述液体瓶上伸缩安装所述第二排气母瓶适配器时，穿刺所述液体瓶塞，所述第二双腔瓶塞穿刺构件包括与所述竖直第二排气母瓶适配器母连接件流动连通的第二液腔，以及与所述至少一个第二排气母瓶适配器上壁排气口流动连通的第二气腔；以及
(c)管状液体传输耦合器，具有纵向液体传输耦合器中心线，并包括第一液体传输耦合器端和第二液体传输耦合器端，所述第一液体传输耦合器端用于耦合至所述第一排气母瓶适配器，所述第二液体传输耦合器端用于耦合至所述第二排气母瓶适配器，以在所述第一排气母瓶适配器和所述第二排气母瓶适配器之间建立双密封腔设置，
所述液体传输耦合器包括纵向气腔壁，所述纵向气腔壁用以在所述至少一个第一排气母瓶适配器上壁排气口和所述至少一个第二排气母瓶适配器上壁排气口之间建立所述双密封腔设置的密封气腔，
所述气腔壁包括第一公连接件和相对定向的第二公连接件，所述第一公连接件用于密封插入所述竖直第一排气母瓶适配器母连接件，所述第二公连接件用于密封插入所述竖直第二排气母瓶适配器母连接件，以在所述第一排气母瓶适配器母连接件与所述第二排气母瓶适配器母连接件之间建立中心密封液腔，
所述密封气腔从所述中心密封液腔相对于所述纵向液体传输耦合器中心线径向向外，
所述双瓶适配器组件在使用中，将所述第一排气母瓶适配器伸缩安装于所述药瓶上，将所述第二排气母瓶适配器伸缩安装于所述液体瓶上，并且将所述液体瓶设置在所述药瓶之上，以使液态成分能够通过所述中心密封液腔从所述液体瓶重力流入所述药瓶，从而在所述药瓶中形成液体药物，并将气体通过所述密封气腔从所述药瓶排放至所述液体瓶，随后所述第一排气母瓶适配器从所述液体传输耦合器分离，以使无针注射器能够附接至所述竖直第一排气母瓶适配器母连接件，从而从所述竖直第一排气母瓶适配器母连接件吸入液态成分。
2.根据权利要求1所述的组件，其中
所述第一排气母瓶适配器上壁包括：(i)内部围绕物，所述内部围绕物关于所述至少一个第一排气母瓶适配器上壁排气口相对于所述纵向第一排气母瓶适配器中心线径向向外，并且围绕所述竖直第一排气母瓶适配器母连接件，和(ii)外部围绕物，所述外部围绕物围绕所述内部围绕物，
所述第二排气母瓶适配器上壁包括：(i)内部围绕物，所述内部围绕物关于所述至少一个第二排气母瓶适配器上壁排气口相对于所述纵向第一排气母瓶适配器中心线径向向外，并且围绕所述竖直第二排气母瓶适配器母连接件，和(ii)外部围绕物，所述外部围绕物围绕所述内部围绕物，以及
在所述第一液体传输耦合器端，所述气腔壁密封插入所述第一排气母瓶适配器上壁的内部围绕物和外部围绕物之间，在所述第二液体传输耦合器端，所述气腔壁密封插入所述第二排气母瓶适配器上壁的内部围绕物和外部围绕物之间。
3.根据权利要求1或2所述的组件，其中所述密封气腔围绕所述中央密封液腔。
4.根据权利要求1至3中任一项所述的组件，其中所述液体传输耦合器包括安装在所述气腔壁上的外壁，用于协助操作所述组件。
5.根据权利要求1至4中任一项所述的组件，其中在所述第一液体传输耦合器端，所述气腔壁与所述第一排气母瓶适配器上壁接合，在所述第二液体传输耦合器端，所述气腔壁与所述第二排气母瓶适配器上壁接合。
6.根据权利要求1至4中任一项所述组件，其中所述气腔壁包括内部第一螺纹和内部第二螺纹，所述内部第一螺纹与所述第一排气母瓶适配器母连接件接合，所述内部第二螺纹用于与所述第二排气母瓶适配器母连接件接合。
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