CN109310573B - 包括通气式药瓶转接器和通气式液体瓶转接器的双瓶转接器组合件 - Google Patents

包括通气式药瓶转接器和通气式液体瓶转接器的双瓶转接器组合件 Download PDF

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CN109310573B
CN109310573B CN201780032222.3A CN201780032222A CN109310573B CN 109310573 B CN109310573 B CN 109310573B CN 201780032222 A CN201780032222 A CN 201780032222A CN 109310573 B CN109310573 B CN 109310573B
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vial adapter
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伊格·德仁伯格
阿米尔·列弗
乌瑞·大卫
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West Pharma Services IL Ltd
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    • AHUMAN NECESSITIES
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    • A61J1/14Details; Accessories therefor
    • A61J1/20Arrangements for transferring or mixing fluids, e.g. from vial to syringe
    • A61J1/2089Containers or vials which are to be joined to each other in order to mix their contents
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61JCONTAINERS SPECIALLY ADAPTED FOR MEDICAL OR PHARMACEUTICAL PURPOSES; DEVICES OR METHODS SPECIALLY ADAPTED FOR BRINGING PHARMACEUTICAL PRODUCTS INTO PARTICULAR PHYSICAL OR ADMINISTERING FORMS; DEVICES FOR ADMINISTERING FOOD OR MEDICINES ORALLY; BABY COMFORTERS; DEVICES FOR RECEIVING SPITTLE
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    • A61JCONTAINERS SPECIALLY ADAPTED FOR MEDICAL OR PHARMACEUTICAL PURPOSES; DEVICES OR METHODS SPECIALLY ADAPTED FOR BRINGING PHARMACEUTICAL PRODUCTS INTO PARTICULAR PHYSICAL OR ADMINISTERING FORMS; DEVICES FOR ADMINISTERING FOOD OR MEDICINES ORALLY; BABY COMFORTERS; DEVICES FOR RECEIVING SPITTLE
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    • A61J1/14Details; Accessories therefor
    • A61J1/20Arrangements for transferring or mixing fluids, e.g. from vial to syringe
    • A61J1/2003Accessories used in combination with means for transfer or mixing of fluids, e.g. for activating fluid flow, separating fluids, filtering fluid or venting
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    • A61J1/14Details; Accessories therefor
    • A61J1/20Arrangements for transferring or mixing fluids, e.g. from vial to syringe
    • A61J1/2003Accessories used in combination with means for transfer or mixing of fluids, e.g. for activating fluid flow, separating fluids, filtering fluid or venting
    • A61J1/202Separating means
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    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61JCONTAINERS SPECIALLY ADAPTED FOR MEDICAL OR PHARMACEUTICAL PURPOSES; DEVICES OR METHODS SPECIALLY ADAPTED FOR BRINGING PHARMACEUTICAL PRODUCTS INTO PARTICULAR PHYSICAL OR ADMINISTERING FORMS; DEVICES FOR ADMINISTERING FOOD OR MEDICINES ORALLY; BABY COMFORTERS; DEVICES FOR RECEIVING SPITTLE
    • A61J1/00Containers specially adapted for medical or pharmaceutical purposes
    • A61J1/14Details; Accessories therefor
    • A61J1/20Arrangements for transferring or mixing fluids, e.g. from vial to syringe
    • A61J1/2003Accessories used in combination with means for transfer or mixing of fluids, e.g. for activating fluid flow, separating fluids, filtering fluid or venting
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    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
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    • A61J1/20Arrangements for transferring or mixing fluids, e.g. from vial to syringe
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    • A61J1/2068Venting means
    • A61J1/2075Venting means for external venting
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61JCONTAINERS SPECIALLY ADAPTED FOR MEDICAL OR PHARMACEUTICAL PURPOSES; DEVICES OR METHODS SPECIALLY ADAPTED FOR BRINGING PHARMACEUTICAL PRODUCTS INTO PARTICULAR PHYSICAL OR ADMINISTERING FORMS; DEVICES FOR ADMINISTERING FOOD OR MEDICINES ORALLY; BABY COMFORTERS; DEVICES FOR RECEIVING SPITTLE
    • A61J1/00Containers specially adapted for medical or pharmaceutical purposes
    • A61J1/14Details; Accessories therefor
    • A61J1/20Arrangements for transferring or mixing fluids, e.g. from vial to syringe
    • A61J1/2003Accessories used in combination with means for transfer or mixing of fluids, e.g. for activating fluid flow, separating fluids, filtering fluid or venting
    • A61J1/2079Filtering means
    • A61J1/2082Filtering means for gas filtration
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
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    • A61J1/00Containers specially adapted for medical or pharmaceutical purposes
    • A61J1/14Details; Accessories therefor
    • A61J1/20Arrangements for transferring or mixing fluids, e.g. from vial to syringe
    • A61J1/2096Combination of a vial and a syringe for transferring or mixing their contents

Abstract

与药瓶和液体瓶一起使用的双瓶转接器组合件,该双瓶转接器组合件包括通气式药瓶转接器和通气式液体瓶转接器使得液体瓶和药瓶的同时通气帮助液体内含物从液体瓶重力流动到药瓶中用于在药瓶中形成液体药物。

Description

包括通气式药瓶转接器和通气式液体瓶转接器的双瓶转接器 组合件
技术领域
本发明涉及与包含药剂的药瓶和包含液体内含物的液体瓶一起使用的双瓶转接器组合件。
技术背景
双瓶转接器组合件包括用于伸缩地安装在液体瓶上的液体瓶转接器和用于伸缩地安装在药瓶上的药瓶转接器,该双瓶转接器组合件用来与包含药剂的药瓶和包含液体内含物的液体瓶一起使用,该液体内含物用来与药瓶中的药剂混合或重构药瓶中的药物以形成液体药物。双瓶转接器组合件通常被分为以下两类型:负压类型、重力流动类型,该负压类型目的是与负压下的药瓶一起使用用来从液体瓶中正压抽取液体内含物到该药瓶中。该重力流动类型利用液体内含物从液体瓶重力流动到药瓶。前一类型通常被用于准备小的液体药物剂量,后一类型通常被用于准备大的液体药物体积,该大的液体药物体积适合用来投予几个小的液体药物剂量或用来与IV输液器一起使用。
一个典型的负压类型的双瓶转接器组合件被公开在共同拥有的美国专利号6,558,365 (Zinger等,发明名称:液体转移装置)中,其包括具有公连接头的液体瓶转接器和具有母连接头的药瓶转接器。该公连接头优选地是公鲁尔锁接头并且该母连接头优选地是母鲁尔锁接头,该母鲁尔锁接头具有用于在其上螺纹连接母鲁尔锁接头的螺纹。这样的双瓶转接器组合件从West Pharmaceutical Services,Inc.,Exton,USA可市售购得,注册商标是MIX2VIAL。
另一个典型的负压类型的双瓶转接器组合件被公开在共同拥有的美国专利号 8,684,994(Lev等人,发明名称:具有通气式装置的流体转移组合件(Fluid TransferAssembly with Venting Arrangement))中。该双瓶转接器组合件包括通气式母小瓶转接器(vented female vial adapter)和公小瓶转接器。该通气式母小瓶转接器包括通气装置,该公小瓶转接器包括用于选择性密该通气式装置的密封装置。该双瓶转接器组合件经设计使得在重构液体药剂内含物之后在负压下仅仅过滤的空气被抽到药瓶中以保证无菌条件。
具体地,该负压类型的双瓶转接器组合件要求用户将液体瓶转接器初始地伸缩地安装在液体瓶上,并且就在此之后,将药瓶转接器伸缩地安装在药瓶上,否则负压损失,从而使得该双瓶转接器组合件不可操作。负压泄漏或负压不足可能导致液体内含物从液体瓶到药瓶抽取不充分。
一个典型的重力流动类型的双瓶转接器组合件被公开在共同拥有的美国专利号8,752,598(Denenburg等人,发明名称:液体药物转移组合件)中。美国专利号8,752,598 图9显示了双瓶转接器组合件,该双瓶转接器组合件包括具有母连接头的药瓶转接器和具有用于穿刺液体瓶瓶塞和药瓶瓶塞的双腔双末端液体转移矛状物的液体瓶转接器。有利地是,该双瓶转接器组合件并不要求伸缩地安装在液体瓶和药瓶上的具体顺序,但是相比液体内含物的正压抽取,液体内含物通过双腔双末端液体转移矛状物从液体瓶到药瓶的基于重力的转移可能需要更长时间。再者,这样的双瓶转接器组合件可遭受液体内含物从液体瓶到药瓶的不完全转移。
需要双瓶转接器组合件,该双瓶转接器组合件用来促使全部液体内含物从液体瓶到药瓶的快速转移,不论药瓶是否是在负压下。
发明内容
本发明针对的是双瓶转接器组合件(Dual vial adapter assemblages),该双瓶转接器组合件包括a)通气式药瓶转接器(vented drug vial adapter)和b)通气式液体瓶转接器 (vented liquid vial adapter),该通气式药瓶转接器具有双腔药瓶瓶塞穿刺套管,该双腔药瓶瓶塞穿刺套管具有i)与药瓶转接器接头流体连通的液体腔和ii)通气式通气腔 (vented air lumen),该通气式液体瓶转接器具有双腔液体瓶瓶塞穿刺套管,该双腔液体瓶瓶塞穿刺套管具有i)与液体瓶转接器接头流体连通的液体腔和ii)通气式通气腔。在该双瓶转接器组合件的安装位置,该药瓶转接器接头与该液体瓶转接器接头流体连通,使得将该液体瓶转接器初始地伸缩地安装在该液体瓶上和将该药瓶转接器初始地伸缩地安装在该药瓶上时,随后在药瓶上方设置液体瓶导致该液体瓶通过该双腔液体瓶瓶塞穿刺套管的通气式通气腔和该药瓶通过该双腔药瓶瓶塞穿刺套管的通气式通气腔的同时通气用于帮助液体内含物从该液体瓶重力流动到该药瓶,用于在该药瓶中形成液体药物。提供通气式药瓶转接器和通气式液体瓶转接器保证了全部液体内含物从液体瓶到药瓶的快速转移,不论该药瓶是否处于负压下。
在本发明的双瓶转接器组合件的一个优选实施方案中,该药瓶转接器接头是母连接头,该液体瓶转接器接头是用来与母连接头密封配合的公连接头。因此,该双瓶转接器组合件具有与迄今提到的Zinger双瓶转接器组合件类似的构造,除了它的药瓶转接器和液体瓶转接器是通气的。该公连接头优选地是公鲁尔锁接头,该母连接头优选地是母鲁尔锁接头。
在本发明的双瓶转接器组合件的其它的优选实施方案中,该药瓶转接器和该液体瓶转接器均具有公连接头和母连接头。在这样的情况下,该双瓶转接器组合件包括中间的双末端液体转移连接器,该中间的双末端液体转移连接器具有呈母连接头或公连接头形式的一对相对的连接器端。因此,这样的双瓶转接器组合件提供了液体瓶转接器和药瓶转接器同样可被伸缩地安装在药瓶或液体瓶上的优势。
本发明的双瓶转接器组合件优选地被提供在安装位置,准备用于在从合适的无菌包装中移出时直接使用。或者,该双瓶转接器组合件可要求在使用之前由用户组装。
打算用于准备大体积的液体药物用于输液目的的本发明的双瓶转接器组合件优选地包括经设计用于从小瓶快速释放的小瓶转接器,如PCT国际公开号WO 2012/150587(发明名称:小瓶转接器)所公开的。因此,通气式药瓶转接器可很容易从包含液体药物的药瓶上移除,从而暴露它的药瓶瓶塞用于IV输液装置的插入,用来向患者输注液体药剂。
附图的简要说明
为了理解本发明并且明白如何在实践中实施它,仅仅通过非限制性实施方案,参照附图,现在描述优选实施方案,其中类似的部分被做了同样标记,并且其中:
图1是根据本发明的第一优选实施方案的给药装置的示图,该给药装置包括无针注射器、药瓶、液体瓶、IV输液器以及双瓶转接器组合件;
图2是图1的双瓶转接器组合件的分解图;
图3是图1的双瓶转接器组合件沿着图1中的线A-A的纵向截面图;
图4是图1中双瓶转接器组合件沿着图1中的线A-A的纵向截面图,显示了液体内含物从液体瓶到药瓶的转移;
图5A到图5F显示了给药装置的使用;
图6是根据本发明的第二优选实施方案的双瓶转接器组合件的透视图;
图7是图6的双瓶转接器组合件的分解图;
图8是图6双瓶转接器组合件沿着图6中的线B-B的纵向截面图;
图9是根据本发明的第三优选实施方案的双瓶转接器组合件的透视图;
图10是图9的双瓶转接器组合件的分解图;以及
图11是图9的双瓶转接器组合件沿着图9中的线C-C的纵向截面图。
本发明的优选实施方案的详细描述
图1显示了输液装置5,输液装置5包括初始空的无针注射器10、药瓶20、液体瓶30、输液器40(按减小比例显示的)和药瓶转接器组合件100。无针注射器10包括具有活塞12 和公鲁尔锁接头13的针筒11。注射器10可以与其它类型的公连接头一起形成。药瓶20具有纵向的药瓶轴20A并且包括具有药瓶瓶冠22和窄直径的药瓶瓶颈23的顶部开口的药瓶瓶体21。药瓶瓶冠22是由药瓶瓶塞24密封的。药瓶瓶塞24是由铝带26密封的。药瓶20 包含呈粉末、固体或液体形式的药剂27。液体瓶30具有纵向的药瓶轴30A并且包括具有液体瓶瓶冠32和窄直径药瓶瓶颈33的顶部开口的液体瓶瓶体31。液体瓶瓶冠32是由液体瓶瓶塞34密封的。液体瓶塞34是由铝带36密封的。液体瓶30包括仅仅呈稀释剂形式或呈活性成分形式的液体内含物37。IV输液器40包括IV矛状物41、第一管子42、夹钳43、滴注室44、第二管子46、滚动夹子(roller clamp)47、公鲁尔锁接头(male Luer connector) 48和鲁尔防护物(Luer shield)49。第一管子42通常具有4.1mm x 200mm的大小,并且第二管子46通常具有4.1mm和500mm的大小。
图2和图3显示了双瓶转接器组合件100,其具有纵向的双瓶转接器组合件中心线101 并且包括通气式药瓶转接器110和通气式液体瓶转接器120。
通气式药瓶转接器110具有纵向的药瓶转接器中心线111并且包括横向的药瓶转接器顶壁112。药瓶转接器顶壁112具有直立的药瓶转接器接头113,直立的药瓶转接器接头113 优选地是由母鲁尔锁接头(female Luer connector)构成,该母鲁尔锁接头包括用于被公鲁尔锁接头螺纹配合的外部螺纹。药瓶转接器顶壁112具有相反指向的药瓶转接器裙114 用于在药瓶20上的伸缩安装。药瓶转接器顶壁112包括双腔药瓶瓶塞穿刺套管116,用于将通气式药瓶转接器110伸缩地安装在药瓶20上时穿刺药瓶瓶塞24。双腔药瓶瓶塞穿刺套管116包括与药瓶转接器接头113流体连通的液体腔117和具有在药瓶转接器顶壁112中形成的贯穿孔119的通气式通气腔118。液体腔117通常具有比通气式通气腔118宽的直径。通气式液体瓶转接器120具有纵向的液体瓶转接器中心线121并且包括横向的液体瓶转接器顶壁122。液体瓶转接器顶壁122具有直立的液体瓶转接器接头123,直立的液体瓶转接器接头123优选地是由公鲁尔锁接头(female Luer connector)构成的,用于螺纹配合在母鲁尔锁接头113上。液体瓶转接器顶壁122具有相反指向的液体瓶转接器裙124用于在液体瓶30上的伸缩安装。液体瓶转接器顶壁122包括双腔液体瓶瓶塞穿刺套管126,用于将通气式液体瓶转接器120伸缩地安装在液体瓶30上时穿刺液体瓶瓶塞34。双腔液体瓶瓶塞穿刺套管126包括与液体瓶转接器接头123流体连通的液体腔127和具有在液体瓶转接器顶壁122形成的贯穿孔129的通气式通气腔128。液体腔127通常具有比通气式通气腔 128宽的直径。液体瓶转接器120可任选地包括用于过滤进入的空气的空气过滤器。
图4显示了液体内含物从液体瓶30通过液体腔127、液体瓶转接器接头123、药瓶转接器113和液体腔117的重力流动到药瓶20,如箭头A所示。图4显示了通过经由通气式通气腔128空气被抽取到液体瓶30中(如箭头B所示)和经由通气式通气腔118空气从药瓶20中被排出(如箭头C所示)来促进的重力流动。
图5A到图5F显示了给药装置5用于在药瓶20中准备液体药物准备向患者投予的使用。图5A显示了在液体瓶30上伸缩安装通气式液体瓶转接器120,用来穿刺液体瓶30。图5B显示了连同连接的液体瓶30一起倒置双瓶转接器组合件100并且将通气式药瓶转接器110伸缩地安装在药瓶20上用来穿刺药瓶20,从而导致液体内含物从液体瓶30重力流动到药瓶20以在其中形成液体药物。图5C显示了从通气式药瓶转接器110上拧下通气式药瓶转接器120。图5D显示了将注射器10拧紧在通气式药瓶转接器110上用于从药瓶20中抽吸液体药物剂量用于向患者投予。图5E显示了通气式药瓶转接器110从药瓶20移除。图5F 显示了IV输液器40与药瓶20的连接用于向患者输送液体药物。
图6到图8显示了在结构和操作上类似双瓶转接器100的双瓶转接器200。后者200与前者100不同之处在于后者200具有与双重组件构造(dual component construction)不同的三重组件构造。后者200包括通气式小瓶转接器130、通气式小瓶转接器140和在通气式小瓶转接器130和通气式小瓶转接器140中间的双末端液体转移连接器(dual endedliquid transfer coupler)150。通气式小瓶转接器130和通气式小瓶转接器140与通气式药瓶转接器110相同并且相应地包括母鲁尔锁接头131和母鲁尔锁接头141。双末端液体转移连接器150与双重的相对的公鲁尔锁接头151和152一起形成,用于与母鲁尔接头131 和母鲁尔接头141相应的密封的互相配合。
双瓶转接器组合件200的使用与双瓶转接器组合件100相同,除了通气式小瓶转接器 130和通气式小瓶转接器140中的一个可初始地伸缩地安装在液体瓶30上并且通气式小瓶转接器130和通气式小瓶转接器140的其它可用小瓶转接器随后伸缩地安装在药瓶20上以在药瓶20中准备液体药物。在这之后,双末端液体转移连接器150和伸缩的安装在空的液体瓶30上的通气式小瓶转接器130或通气式小瓶转接器140被移除用于实现从图5C向前的使用。
图9到图11显示了在结构与操作方面类似双瓶转接器组合件200的双瓶转接器组合件 300。后者300不同前者200的区别在于后者300包括与通气式液体瓶转接器120相同的通气式小瓶转接器160和通气式小瓶转接器170,并且相应地包括公鲁尔锁接头161和公鲁尔锁接头171。相应地,后者300包括双末端液体转移连接器180,双末端液体转移连接器180与双重的相对的母鲁尔接头181和182一起形成用于与公鲁尔锁接头161和公鲁尔锁接头171相应的密封的互相配合。
双瓶转接器组合件300的使用与双瓶转接器组合件200相同,除了双末端液体转移连接器180被靠左连接到伸缩地安装在药瓶20上的通气式小瓶转接器160或通气式小瓶转接器170,药瓶20包含准备用于注射抽吸和/或输液的液体药物。
虽然本发明的具体实施方案被说明和描述了,对本领域技术人员来说,很明显,不同的其它变化和修改可以在不脱离本发明的精神和范围的情况下被做出。

Claims (4)

1.与药瓶、液体瓶和无针注射器一起使用的双瓶转接器组合件,所述药瓶具有药瓶瓶体和密封所述药瓶瓶体的药瓶瓶塞,所述药瓶包含药剂,所述液体瓶具有液体瓶瓶体和密封所述液体瓶瓶体的液体瓶瓶塞,所述液体瓶包含用来与所述药瓶中的药剂混合或重构所述药瓶中的药剂以在所述药瓶中形成液体药物的液体内含物,所述无针注射器是空的,所述双瓶转接器组合件具有纵向的双瓶转接器组合件中心线并且包括:
(a)通气式药瓶转接器,所述通气式药瓶转接器具有纵向的药瓶转接器中心线并且包括具有直立的药瓶转接器接头的横向的药瓶转接器顶壁、用于伸缩地安装在所述药瓶上的相反指向的药瓶转接器裙和用于在所述伸缩地安装所述通气式药瓶转接器在所述药瓶上时穿刺所述药瓶瓶塞的双腔药瓶瓶塞穿刺套管,所述双腔药瓶瓶塞穿刺套管具有i)与所述药瓶转接器接头流体连通的液体腔和ii)与周围环境敞开通气的通气式通气腔;和
(b)通气式液体瓶转接器,所述通气式液体瓶转接器具有纵向的液体瓶转接器中心线并且包括具有直立的液体瓶转接器接头的横向的液体瓶转接器顶壁、用于伸缩地安装在所述液体瓶上的相反指向的液体瓶转接器裙和用于在所述伸缩地安装所述通气式液体瓶转接器在所述液体瓶上时穿刺所述液体瓶瓶塞的双腔液体瓶瓶塞穿刺套管,所述双腔液体瓶瓶塞穿刺套管具有i)与所述液体瓶转接器接头流体连通的液体腔和ii)与周围环境敞开通气的通气式通气腔,
所述通气式药瓶转接器和所述通气式液体瓶转接器是作为分立的组件形成的,
组装是使得在双瓶转接器组合件的安装位置,其中所述药瓶转接器接头与所述液体瓶转接器接头连接并且与所述液体瓶转接器接头流体连通,在将所述通气式液体瓶转接器初始地伸缩地安装在所述液体瓶上和将所述通气式药瓶转接器初始地伸缩地安装在所述药瓶上时,随后的在药瓶上方设置液体瓶导致液体内含物通过所述液体瓶和所述药瓶的同时通气的帮助从所述液体瓶重力流动到所述药瓶,用于在所述药瓶中形成液体药物,所述液体瓶通过所述双腔液体瓶瓶塞穿刺套管的通气式通气腔将周围空气抽取到其中来通气,所述药瓶通过所述双腔药瓶瓶塞穿刺套管的通气式通气腔将空气从其中排到周围环境中来通气,
所述药瓶转接器从所述液体瓶转接器可拆除用于提供所述药瓶转接器接头的入口,用于实现空的无针注射器与所述药瓶转接器接头的连接,用于从所述药瓶中抽吸液体药物剂量,用于向病人给药。
2.根据权利要求1所述的组合件,其中所述液体瓶转接器接头是公连接头,并且所述药瓶转接器接头是用来与所述公连接头直接密封配合的母连接头。
3.根据权利要求1所述的组合件,所述液体瓶转接器接头和所述药瓶转接器接头中的每者都是母连接头并且所述双瓶转接器组合件进一步包括双末端液体转移连接器,所述双末端液体转移连接器具有一对呈公连接头形式的相对的连接器端用于在所述安装位置与所述液体瓶转接器接头和所述药瓶转接器接头密封地配合。
4.根据权利要求1所述的组合件,所述液体瓶转接器接头和所述药瓶转接器接头中的每者都是公连接头并且所述双瓶转接器组合件进一步包括双末端液体转移连接器,所述双末端液体转移连接器具有一对呈母连接头形式的相对的连接器端用于在所述安装位置与所述液体瓶转接器接头和所述药瓶转接器接头密封地配合。
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