CN104703573A - 伸缩式母药瓶转接器 - Google Patents

伸缩式母药瓶转接器 Download PDF

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CN104703573A
CN104703573A CN201280075575.9A CN201280075575A CN104703573A CN 104703573 A CN104703573 A CN 104703573A CN 201280075575 A CN201280075575 A CN 201280075575A CN 104703573 A CN104703573 A CN 104703573A
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medicine bottle
vial adapter
skirt element
lower limb
spear component
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CN104703573B (zh
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尼姆罗德·列费
伊戈·德恩布鲁格
莫迪凯·布赫曼
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West Pharma Services IL Ltd
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Medimop Medical Projects Ltd
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    • A61J1/20—Arrangements for transferring or mixing fluids, e.g. from vial to syringe
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    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
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    • A61J1/14—Details; Accessories therefor
    • A61J1/20—Arrangements for transferring or mixing fluids, e.g. from vial to syringe
    • A61J1/2096—Combination of a vial and a syringe for transferring or mixing their contents
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61J—CONTAINERS 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
    • A61J1/00—Containers specially adapted for medical or pharmaceutical purposes
    • A61J1/14—Details; Accessories therefor
    • A61J1/20—Arrangements for transferring or mixing fluids, e.g. from vial to syringe
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    • A61J1/2006—Piercing means
    • A61J1/201—Piercing means having one piercing end
    • A—HUMAN NECESSITIES
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    • A61J1/00—Containers specially adapted for medical or pharmaceutical purposes
    • A61J1/14—Details; Accessories therefor
    • A61J1/20—Arrangements for transferring or mixing fluids, e.g. from vial to syringe
    • A61J1/2003—Accessories used in combination with means for transfer or mixing of fluids, e.g. for activating fluid flow, separating fluids, filtering fluid or venting
    • A61J1/2048—Connecting means
    • A61J1/2065—Connecting means having aligning and guiding means

Abstract

伸缩式母药瓶转接器包括伸缩地安装到裙边构件上的矛状物构件，该裙边构件用于在致动位置卡扣安装到药瓶上并且刺穿药瓶。该伸缩式母药瓶转接器尤其适合于通气模式下操作以避免在从药瓶抽吸液体内含物期间弄湿其空气过滤器。

Description

伸缩式母药瓶转接器
技术领域
概括地说，本发明涉及药瓶转接器，具体地说，涉及母(阴)药瓶转接器(femaledrug vial adapters)。
背景技术
共同拥有的发明名称为用于保守正确地卡扣安装到药用药瓶上的液体药物转移装置并且在PCT国际公开号WO 2007/017868下公布的PCT国际申请号PCT/IL2006/000912阐明和描述了液体药物转移装置，该液体药物转移装置包括经设计用于与药瓶，在其上卡扣安装并且刺穿之前，导向对齐以确保与药瓶内部的流体连通的药瓶转接器。WO 2007/017868中的图4说明了与无针注射器一起使用的通气式母药瓶转接器。
WO 2007/017868中公开的药瓶转接器包括具有向下垂穿刺部件和与该穿刺部件流体连通的相对直立的进入口的顶壁。该顶壁还与围绕该穿刺部件的向下垂大体上圆柱形裙边一起形成。该大体上圆柱形裙边包括比该穿刺部件长的至少四个轴向指向的可弯曲部件以避免在药瓶转接器与药瓶对齐之前穿刺部件接触到药瓶的药瓶瓶塞。该轴向指向的可弯曲部件包括两个非邻近的药瓶固定可弯曲部件和至少两个非邻近的药瓶导向可弯曲部件，该两个非邻近的药瓶固定可弯曲部件用于卡扣安装到药瓶开口上方用于药瓶固定目的，该至少两个非邻近的药瓶导向可弯曲部件比它们对应的药瓶固定可弯曲部件长用于相对于药瓶在其上卡扣安装之前导向药瓶转接器。
WO 2007/017868中公开的通气式母药瓶转接器包括具有液体转移腔和通气腔的双腔刺穿部件。该液体转移腔与母连接头流体连通用于密封地接收无针注射器。通气腔与形成于该顶壁上的大体上圆形空气过滤器流体连通。倒置通气式母药瓶转接器用于抽吸其液体药物内含物导致液体药物内含物不想要地进入通气腔和弄湿空气过滤器，因此较大程度地降低其在抽吸期间使得已过滤的空气从中穿过用于压力均衡化目的的能力。
用于相对于药瓶，在其上安装并且穿刺之前，导向对齐的但具有较长的穿刺部件的母药瓶转接器是非常有必要。
发明内容
本发明针对的是包括双组件构造(dual component construction)的母药瓶转接器，该双组件构造具有伸缩地安装在裙边构件上的矛状物构件，该矛状物构件用于从安装位置手动移动到致动位置用于紧固地在药瓶上安装并且刺穿药瓶。该矛状物构件朝向该裙边构件的手动移动提供相对于药瓶，在其上紧固地安装并且刺穿之前，的药瓶转接器的初始导向对齐。
本发明的通气式母药瓶转接器尤其有优势，该通气式母药瓶转接器可设置有长刺穿部件，该长刺穿部件具有带有在其刺穿尖端的通气式腔孔的通气腔。该通气式母药瓶转接器准备与无针注射器一起使用，该无针注射器填充有预定体积的液体内含物使得，当倒置安装在具有液体药物内含物的药瓶上的通气式母药瓶转接器用于抽吸目的时，该通气腔孔以类似于游泳用的通气管的方式在液体药物内含物的液体水平面之上。由于这种配置，液体药物内含物不会进入通气孔并且弄湿该空气过滤器。
附图说明
为了理解本发明并且理解在实践中如何实施它，参考附图，仅仅借助于非限制性实施例，优选的实施例将被描述，其中相同的部分做了同样的编号，其中：
图1是注射器，包括纵向横截面的药瓶和具有纵向药瓶转接器轴在安装位置的通气伸缩式母药瓶转接器的图示；
图2是通气伸缩式母药瓶转接器的分解图；
图3是通气伸缩式母药瓶转接器沿纵向药瓶转接器的俯视图；
图4是通气伸缩式母药瓶转接器沿图3中A-A线在安装位置的纵向截面图；
图5是通气伸缩式母药瓶转接器沿图3中B-B线在其安装位置的纵向截面图；
图6是通气伸缩式母药瓶转接器沿图3中A-A线在致动位置的纵向截面图；
图7是通气伸缩式母药瓶转接器沿图3中B-B线在其致动位置的纵向截面图；
图8A是通气伸缩式母药瓶转接器和药瓶沿图3中A-A线在使用前的纵向截面图；
图8B是通气伸缩式母药瓶转接器和药瓶沿图3中A-A线的纵向截面图，根据朝向后者初始向下按压前者；
图8C是通气伸缩式母药瓶转接器和药瓶沿图3中A-A线的纵向截面图，根据朝向后者继续向下按压前者；
图8D是通气伸缩式母药瓶转接器完全安装在药瓶上并且刺穿药瓶沿图3中A-A线的纵向截面图；
图8E是通气伸缩式母药瓶转接器完全安装在药瓶上并且刺穿药瓶沿图3中B-B线的纵向截面图；
图8F是通气伸缩式母药瓶转接器和药瓶沿图3中A-A线的纵向截面图，此时无针注射器螺纹安装在前者上用于注射目的；以及
图8G是倒置用于抽吸目的后，通气伸缩式母药瓶转接器和药瓶沿图3中A-A线的纵向截面图。
本发明优选实施例的详细描述
图1显示构成生理液体源的注射器10，药用药瓶20和用于和注射器10以及药瓶20一起使用的通气伸缩式母药瓶转接器30。注射器10包括具有活塞12的套筒11和公鲁尔锁接头13。注射器10可与其他类型的公连接头一起形成。注射器10填充有液体组分14。液体组分14可仅仅是稀释剂。或者，液体组分14可包括活性成分。
药瓶20具有纵向的药瓶轴20A并且包括药瓶瓶体21，该药瓶瓶体21具有药瓶肩22，药瓶边缘23和中间的窄药瓶颈24。药瓶边缘23限定药瓶开口26，药瓶开口26由被带子28包覆的药瓶瓶塞27密封。药瓶20含有负压下的粉末状药物29或液体药物29。
图1到图7显示通气伸缩式母药瓶转接器30具有纵向的药瓶转接器轴31并且包括通气矛状物构件32，裙边构件33和固定配置(securing arrangement)34，该固定配置34用于在致动位置在裙边构件33上固定矛状物构件32，如图6和7中所示。
通气矛状物构件32包括横向指向的矛状物构件顶壁36，该矛状物构件顶壁36具有圆形空气过滤器37和一对通气孔38。通气矛状物构件32优选地包括保护罩38，如共同拥有的在PCT国际公开号WO 2011/104712下公布的发明名称为具有通气小瓶转接器的液体药物转移装置的PCT国际申请号PCT/2011/000187中所说明和描述的。
矛状物顶壁36包括向下垂双腔刺穿部件39和相对的直立母连接头42，该向下垂双腔刺穿部件39具有用于刺穿药瓶瓶塞的刺穿尖端41。母连接头42优选是具有外螺纹43的母鲁尔连接头。双腔刺穿部件39包括与相对的直立母连接头42流体连通的液体转移腔44。双腔刺穿部件39包括通气腔46，该通气腔46具有与刺穿尖端41邻近的并且与该对通气孔38流体连通的通气腔孔47。
矛状物构件顶壁36包括朝向直立的母连接头42的最上矛状物构件顶壁表面36A和朝向双腔刺穿部件39的最低矛状物构件顶壁表面36B。刺穿部件39具有限定在最低矛状物构件顶壁表面36B和穿刺尖端41之间的长度L1。
矛状物构件顶壁36还包括位于刺穿部件39外侧的一对相对的空间上分隔的向下垂的矛状物构件腿48。该矛状物构件腿48终止在朝向刺穿尖端41向内突出的腿尖端49。
裙边构件33包括具有中心孔52的横向指向的裙边构件顶壁51和向下垂的大体上圆柱形裙边53。裙边53包括多个药瓶可弯曲部件54和远离裙边构件顶壁51的裙边构件边缘57，该药瓶可弯曲部件54限定药瓶边缘腔56用于在其中紧密地接收药瓶边缘23。药瓶可弯曲部件54优选地包括向内指向的突起58用于卡扣安装到药瓶边缘23上。
裙边构件顶壁51包括朝向矛状物构件32的最上裙边构件顶壁表面51A和朝向裙边53的最低裙边构件顶壁表面51B。裙边53具有限定在最上裙边构件顶壁表面51A和裙边构件边缘(skirt component margin)57的长度L2。
两个相对的药瓶可弯曲部件54A具有腿尖端孔59，该腿尖端孔59用于初始地接收腿尖端49以初始地将矛状物构件顶壁36与裙边构件顶壁51分开，同时伴随穿刺部件39在伸缩式母药瓶转接器30的安装位置中伸出通过中心孔52。药瓶可弯曲部件54A优选地与位于腿尖端孔59下面的平滑的外部表面61一起形成以实现腿尖端49朝向裙边构件边缘57的平滑滑动移动。
在安装位置中，最低矛状物构件顶壁表面36B和最上裙边构件顶壁表面51A由长度L3分隔。在安装位置中，L1<L2+L3使得穿刺尖端41没有伸出超过裙边构件边缘57，这导致在调整通气伸缩式母药瓶转接器30和药瓶20的对齐之前，刺穿尖端41接触药瓶瓶塞27。刺穿部件39和裙边53优选地被设计尺寸使得L1＞L2使得通气尖端孔47在致动位置伸出超过裙边构件边缘57，其中矛状物构件32充分地紧靠裙边组件33。
固定配置34包括一对与该对相对的矛状物构件腿48垂直的相对的扣合夹子(snap fit clip)62。
图8A到图8G显示无针注射器10，药瓶20和通气伸缩式母药瓶转接器30的使用。无针注射器10填充有预定体积的液体内含物29以保证通气管样的效果使得液体内含物不会弄湿圆形空气过滤器37，正如以下图8G中所描述的。
图8A显示在母药瓶转接器30其安装位置中，且与药瓶20同轴对齐准备用于在其上卡扣安装和刺穿药瓶20。
图8B显示如箭头A所示朝向药瓶20初始向下按压母药瓶转接器30。腿尖端49向裙边构件33施加向下的力。可弯曲部件54保证在刺穿部件41开始刺穿药瓶瓶塞27之前不对齐的情况下，矛状物构件32与裙边构件33对齐。
图8C显示如箭头B所示朝向药瓶20继续向下按压药瓶转接器30引起刺穿部件39刺穿药瓶瓶塞27。药瓶20从腿尖端孔59径向向外推动腿尖端49。在负压药瓶20的情况下，空气经由液体转移腔44和通气腔46进入药瓶20。
图8D和图8E显示如箭头C所示完全向下压药瓶转接器30朝向药瓶20直到前者30卡扣安装到药瓶瓶塞27并且刺穿药瓶瓶塞27。矛状物构件32停止靠到裙边构件33。腿尖端49沿着平滑的外部表面61朝向裙边构件边缘57滑动。固定配置34被啮合以固定药瓶转接器30和药瓶20。
图8F显示注射器10准备用于螺纹安装到母药瓶转接器30上用于注射其液体内含物29。注射器10，药瓶20和母药瓶转接器30的组合件被缓慢地推动以确保完全地重构粉末状内含物。当注射液体内含物时，空气通过通气腔46和通气孔38从药瓶20排除。
图8G显示如箭头D所示倒置图8F的组件用于从药瓶20抽吸液体内含物到注射器10用于给药目的。通气腔孔47在药物液体内含物的液体水平面之上以类似于游泳用的通气管使得空气过滤器37没有被弄湿。空气通过通气孔38，空气过滤器37和通气腔46被吸入到药瓶20中。
虽然本发明已经描述了有限数目的实施例，本发明的许多变化，修改以及其它应用能在本申请权利要求书的范围内被做出。

Claims (5)

1.与药瓶一起使用的伸缩式母药瓶转接器，所述药瓶包括含有药剂的药瓶瓶体，限定药瓶开口的药瓶边缘，所述药瓶开口由药瓶瓶塞塞住，所述药瓶转接器具有纵向的药瓶转接器轴，并且包括：
(a)矛状物构件，所述矛状物构件包括横向指向的矛状物构件顶壁，所述矛状物构件顶壁具有
i)具有用于刺穿药瓶瓶塞的刺穿尖端的向下垂刺穿部件和与所述刺穿部件流体连通的相对的直立母连接头，以及
ii)位于所述刺穿部件外侧的至少两个分开的向下垂矛状物构件腿，所述至少两个矛状物构件腿终止在朝向所述刺穿尖端的向内伸出的腿尖端；以及
(b)裙边构件，所述裙边构件包括具有中心孔的横向指向的裙边构件顶壁，多个药瓶可弯曲部件的向下垂大体上圆柱形裙边和远离所述裙边构件顶壁的裙边构件边缘，
所述多个药瓶可弯曲部件限定药瓶边缘腔用于从中紧密地接收药瓶边缘，所述至少两个药瓶可弯曲部件具有腿尖端孔，所述腿尖端孔用于在伸缩式母药瓶转接器的安装位置中初始地接收所述腿尖端以实现随着所述刺穿部件伸出通过所述中心孔，将所述矛状物构件顶壁与所述裙边构件顶壁初始地分开，
该配置是使得当朝向所述裙边构件手动滑动移动所述矛状物构件用于在伸缩式母药瓶转接器的致动位置中靠在所述裙边构件上停止时，所述药瓶可弯曲部件紧密地接收所述药瓶边缘腔中的药瓶边缘，所述刺穿部件刺穿所述药瓶瓶塞，所述腿尖端从它们相应的腿尖端孔被径向向外推动以沿着它们对应的药瓶可弯曲部件朝向所述裙边构件边缘向下滑动。
2.根据权利要求1所述的转接器，所述转接器进一步包括用于在所述致动位置将所述矛状物构件固定在所述裙边构件上的固定配置。
3.根据权利要求2所述的转接器，其中所述矛状物构件包括一对相对的矛状物构件腿，所述固定配置包括一对与所述对相对的矛状物构件腿垂直的相对的卡扣安装夹子。
4.根据权利要求1到3中任一项所述的转接器，其中，所述刺穿部件在所述致动位置伸出超过所述裙边构件边缘。
5.根据权利要求1到4中任一项所述的转接器，其中所述矛状物构件是通气的，所述矛状物构件顶壁包括圆形的空气过滤器和至少一个通气孔，所述刺穿部件包括与所述相对的直立母连接头流体连通的液体转移腔和与所述空气过滤器流体连通的通气腔，所述通气腔包括与所述刺穿部件尖端邻近的通气腔孔。
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US20150231034A1 (en) 2015-08-20
IL237493A0 (en) 2015-04-30
EP2872100B1 (en) 2017-03-29
JP5868555B2 (ja) 2016-02-24
IN2015DN02677A (zh) 2015-09-04
BR112015005157B1 (pt) 2020-12-08
EP2872100A1 (en) 2015-05-20
BR112015005157A2 (pt) 2017-07-04
US9339438B2 (en) 2016-05-17
IL237493B (en) 2018-08-30
WO2014041529A1 (en) 2014-03-20

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