CN115721558A - 包括具有自动密封的入口阀的药瓶转接器的双瓶转接器组件 - Google Patents

包括具有自动密封的入口阀的药瓶转接器的双瓶转接器组件 Download PDF

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CN115721558A
CN115721558A CN202211280101.XA CN202211280101A CN115721558A CN 115721558 A CN115721558 A CN 115721558A CN 202211280101 A CN202211280101 A CN 202211280101A CN 115721558 A CN115721558 A CN 115721558A
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乌瑞·大卫
伊格·德仁伯格
艾丽沙娃·法布里坎特
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Abstract

改进的双瓶转接器组件，包括药瓶转接器、具有公连接头的液体瓶转接器和手动可操作的流体控制装置，所述药瓶转接器具有适合正常关闭的无针可擦拭的自动密封的入口阀的母连接头。该流体控制装置具有三个可操作的位置，包括初始扩展安装位置、中间压紧流体连通位置和用于分离药瓶转接器和液体瓶转接器的最后拆开位置。在初始扩展安装位置和中间压紧流体连通位置液体瓶转接器和药瓶转接器啮合。该自动密封的入口阀在初始扩展安装位置是关闭的并且在中间压紧流体连通位置被按压打开。

Description

包括具有自动密封的入口阀的药瓶转接器的双瓶转接器组件
技术领域
本发明涉及与无针注射器、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件。
背景技术
共同拥有的美国专利号6,558,365(Zinger et al.，发明名称：流体转移装置)公开了与无针注射器、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件。药瓶是处于负压下。无针注射器优选与公鲁尔锁接头一起形成。该药剂可以呈粉末状、固体或液体的形式。该液体内含物可以仅仅呈稀释剂的形式或包括活性成分。根据美国专利号6,558,365构造和操作的双瓶转接器组件从West Pharmaceutical Services,Inc.,Exton,USA市售获得，注册商标是MIX2VIAL。
美国专利号6,558,365中公开的双瓶转接器组件包括用于伸缩地安装在药瓶上的药瓶转接器和用于伸缩地安装在液体瓶上并且与该药瓶转接器初始可释放啮合的液体瓶转接器。该液体瓶转接器包括与液体瓶瓶塞刺穿套管流体连通的公连接头，该液体瓶瓶塞刺穿套管用于当伸缩地安装液体瓶转接器在液体瓶上时刺穿液体瓶瓶塞。该公连接头优选地是公鲁尔锁接头(male Luer lock connector)。药瓶转接器包括与药瓶瓶塞刺穿套管流体连通的母连接头，该药瓶瓶塞刺穿套管用于当伸缩地安装药瓶转接器在药瓶上时刺穿药瓶瓶塞。该母连接头优选地是母鲁尔连接头(female Luer connector)，该母鲁尔连接头具有螺纹用于螺纹连接在其上的公鲁尔锁接头。
美国专利号6,558,365中公开的双瓶转接器组件的使用如下所示：双瓶转接器组件被设置在初始的流体连通位置，其中液体瓶转接器螺纹安装在药瓶转接器上使得液体瓶转接器的公连接头与药瓶转接器的母连接头流体连通。液体瓶转接器伸缩地安装在被放置在水平的工作台上的液体瓶上。双瓶转接器组件被颠倒准备用于伸缩地安装药瓶转接器在放置在水平的工作台上的药瓶上，液体瓶转接器在药瓶转接器上方。在将药瓶转接器伸缩地安装在药瓶上时，负压将液体内含物从液体瓶向下抽吸到药瓶中用于在药瓶中形成液体药物。从药瓶转接器旋开液体瓶转接器并且无针注射器被连接到它的母连接头准备用于抽取药瓶中的液体药物到无针注射器。全部的液体药物内含物可通过一次抽取或两次或接二连三地多次抽取从药瓶中被抽取。在液体瓶转接器从药瓶转接器长时间分离之后的随后抽取通常由于担心没有灭菌被限制。
需要一种双瓶转接器组件，便于在液体瓶转接器从药瓶转接器长时间分离之后在无菌条件下从药瓶中多次抽取液体药物剂量。
发明内容
本发明针对的是类似于上述共同拥有的美国专利号6,558,365的双瓶转接器组件。本发明不同于前者的之处在于本发明包括药瓶转接器和手动可操作的流体控制装置，该药瓶转接器具有适合正常关闭的无针可擦拭的自动密封的入口阀，该正常关闭的无针可擦拭的自动密封的入口阀在其中***母连接头时可选择性地打开到流体连通状态。此类正常关闭的无针可擦拭的自动密封的入口阀尤其可从Halkey Roberts等http://www.halkeyroberts.com/products/medical/general.aspx商业上获得。
该流体控制装置具有以下3个操作位置：第一，初始扩展安装位置，其中该液体瓶转接器啮合该药瓶转接器，该液体瓶转接器的母连接头没有***到该药瓶转接器的公连接头中使得它的自动密封的入口阀保持关闭。第二，中间压紧流体连通位置，用于将该液体瓶转接器的公连接头推入到该母连接头中用于按压自动密封的入口阀到流体连通状态，用来实现该药瓶和该液体瓶之间的流体连通，进而能够在该药瓶中形成液体药物内含物。以及第三，最后拆开位置，用于实现该液体瓶转接器从该药瓶转接器分离从而提供通向自动密封的入口阀的入口，用于重复抽取药瓶中的液体药物内含物。
该扩展安装位置使得该双瓶转接器组件能够在它预期的适用期内存放，而无需担忧正常关闭的自动密封的入口阀由于在它的按压的流体连通状态(该状态可使得它的自动密封能力变差)的长时间存放变得不适合使用。在该双瓶转接器组件的初始扩展安装位置，该液体瓶转接器的公连接头优选地接触该自动密封的入口阀从而在存放期间保持它的无菌。因此，该双瓶转接器组件从它的无菌包装取出即可使用，而无需在第一次抽取液体药物内含物之前擦拭该自动密封的入口阀。或者，在初始扩展安装位置，该公连接头可与该自动密封的入口阀在空间上分隔。因此，该自动密封的入口阀通过手动可移除的标签盖住保持无菌，该手动可移除的标签在使用该双瓶转接器组件之前移除。
本发明的双瓶转接器组件的使用是从美国专利号6,558,365中公开的双瓶转接器组件改动得到的，改进之处在于在药瓶中形成液体药物内含物之前用户需要初始地设置该双瓶转接器组件，从它的初始扩展安装位置到它的中间压紧流体连通位置。本发明的双瓶转接器组件可被实施使得该流体控制装置需要朝向药瓶转接器手动线性压紧液体瓶转接器或需要相对于药瓶转接器手动转动压紧液体瓶转接器用于推动该流体控制装置从它的初始扩展安装位置到它的中间压紧流体连通位置。该流体控制装置可通过不同类型的机械装置(包括包括至少一个钩状部件的钩状部件装置，包括至少一个销和销槽对的卡销装置(bayonet arrangement)，螺纹装置等)实施。
在涉及朝向药瓶转接器线性压紧液体瓶转接器的流体控制装置中，双瓶转接器组件优选地可被包裹在吸塑装置中用于帮助用户按照一套规定的说明使用。吸塑装置包括在它的吸塑装置容器的开放端的内部刚性限制装置，用于防止在将液体瓶转接器伸缩地安装在液体瓶上时液体瓶转接器立即卡扣在液体瓶上。该内部刚性限制装置可被设置为用于安装在吸塑装置容器的开放端内部的分离的限制环或替代地是整体设计特征。合适的安装尤其包括卡扣配合、粘合等。
附图说明
为了理解本发明并且明白在实践中如何实施它，仅仅借助非限制性实例，参照附图(其中类似的部分被做了同样编号)，现在优选的实施方案被描述，并且其中：
图1是根据本发明的第一实施方案，包括无针注射器、药瓶、液体瓶和包括双瓶转接器组件在它的初始扩展安装位置的吸塑装置的给药装置的示图；
图2是吸塑装置和双瓶转接器组件的第一分解透视图；
图3是吸塑装置和双瓶转接器组件的第二分解透视图；
图4A是双瓶转接器组件的分解正视图；
图4B是沿着图4A中的线4B-4B的双瓶转接器组件的纵向截面图；
图4C是沿着图4A中的线4B-4B的双瓶转接器组件在它的初始扩展安装位置的纵向截面图；
图4D是沿着图4A中的线4B-4B的双瓶转接器组件在它的中间压紧流体连通位置的纵向截面图；
图5A是在伸缩的安装双瓶转接器组件在液体瓶上之前，双瓶转接器组件在它的扩展安装位置在吸塑装置和液体瓶中的正视图；
图5B是沿着图5A中的线5B-5B的正视图的纵向截面图；
图6A是在吸塑装置中的双瓶转接器组件和接触液体瓶的液体瓶转接器的正视图；
图6B是沿着图6A中的线6B-6B的正视图的纵向截面图；
图7A是显示了在将双瓶转接器组件初始地伸缩地安装在液体瓶上时液体瓶推动手动可操作的流体控制装置进入到它的中间压紧流体连通位置的正视图；
图7B是沿着图7A中的线7B-7B的正视图的纵向截面图；
图8A是在吸塑装置中的双瓶转接器组件的正视图，其中液体瓶转接器刺穿液体瓶；
图8B是沿着图8A中线8B-8B的正视图的纵向截面图；
图9A是显示了双瓶转接器组件从吸塑装置取出并且颠倒双瓶转接器组件用于将药瓶转接器放置在药瓶上，而没有刺穿药瓶。
图9B是沿着图9A中线9B-9B的正视图的纵向截面图；
图10A是显示了药瓶转接器刺穿药瓶用于将稀释剂从液体瓶抽吸到药瓶用于在药瓶中形成液体药物内含物的正视图；
图10B是沿着图10A中线10B-10B的正视图的纵向截面图；
图11A是显示了连接注射器到药瓶转接器上用于抽取药瓶中的液体药物内含物的正视图；
图11B是沿着图11A中线11B-11B的正视图的纵向截面图；
图12是根据本发明的第二实施方案的双瓶转接器组件在它的初始扩展安装位置的透视图；
图13是图12的双瓶转接器组件在它的中间压紧流体连通位置的透视图；
图14是根据本发明的第三实施方案的双瓶转接器组件在它的初始扩展安装位置的透视图；
图15是图14的双瓶转接器组件的分解图；
图16A是图14的双瓶转接器组件在它的初始扩展安装位置的正视图；
图16B是沿着图16A中线16B-16B的图14的双瓶转接器组件的纵向截面图；
图17A是图14的双瓶转接器组件在它的中间压紧流体连通位置的正视图；
图17B是沿着图17A中线17B-17B的图14的双瓶转接器组件的纵向截面图；
图18A是根据本发明的第四实施方案的双瓶转接器组件在它的初始扩展安装位置的正视图；
图18B是沿着图18A中线18B-18B的双瓶转接器组件的纵向截面图；
图19A是图18A的双瓶转接器组件在它的中间压紧流体连通位置的正视图；以及
图19B是沿着图19A中线19B-19B的双瓶转接器组件的纵向截面图。
具体实施方式
图1显示了给药装置100，包括最初空的无针注射器10、药瓶20、液体瓶30和用于盛放双瓶转接器组件50A的吸塑装置(blister)40。无针注射器10包括具有活塞12和公鲁尔锁接头(male Luer lock connector)13的注射桶11。注射器10可以由其它形式的公连接头组成。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。药瓶冠22是由药瓶瓶塞24密封。药瓶瓶塞24是由铝带26密封。药瓶20包含呈粉末、固体或液体形式的药剂27。药瓶20可以是在负压下。液体瓶30具有纵向的液体瓶轴30A并且包括具有液体瓶瓶冠32和窄直径的液体瓶瓶颈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。液体瓶瓶塞34是由铝带36密封。液体瓶30包含仅仅呈稀释剂形式或呈活性成分形式的液体内含物37。
图2到4显示了吸塑装置40，吸塑装置40包括具有吸塑容器闭合端(blistercontainer closed end)42和吸塑容器开放端(blister container open end)43的末端开口的吸塑容器(open ended blister container)41。吸塑装置40包括用于密封开放端43的密封物44。吸塑容器闭合端42包括保持缺口(retainer indentations)46用于在保持缺口46处保持药瓶转接器80。末端开口的吸塑容器41包括位于它的开放端43的内部刚性限制装置(internal rigid restrainer arrangement)47用于防止在将液体瓶转接器60初始伸缩安装在液体瓶30上时液体瓶转接器60立即卡扣在液体瓶30上。内部刚性限制装置47被实施为分离的限制环48，限制环48通过缺口49卡扣到合适的位置。
双瓶转接器组件(dual vial adapter assemblage)50A具有纵向的双瓶转接器组件中心线51并且包括液体瓶转接器60和与液体瓶转接器60初始相互啮合的药瓶转接器80。双瓶转接器组件50A具有手动可操作的流体控制装置52A，其具有如下所示的3个操作位置：初始扩展安装位置、中间压紧流体连通位置和最后拆开位置。替代的药瓶转接器组件能够与不同的流体控制装置一起操作，该流体控制装置能够呈现如下文描述的预期的3个操作位置。
液体瓶转接器60包括横向的液体瓶转接器顶壁61，液体瓶转接器顶壁61具有直立的公连接头62和用于伸缩地安装在液体瓶30上的相反导向的液体瓶转接器裙63。公连接头62优选地是公鲁尔锁接头。液体瓶转接器60进一步包括液体瓶瓶塞刺穿套管64用于当将液体瓶转接器60伸缩地安装在液体瓶30上时刺穿液体瓶瓶塞34。直立的公连接头62与液体瓶瓶塞刺穿套管64流体连通。限制环48具有一内径，该内径经设计用以紧紧地接收液体瓶转接器裙63(在其非弯曲位置)并且防止液体瓶转接器裙63打开卡扣在液体瓶30上。
液体瓶转接器60进一步包括安装在横向的液体瓶转接器顶壁61上且包围直立的公连接头62的直立的圆柱形套筒66。直立的圆柱形套筒66具有面向药瓶转接器80的前套筒边缘(leading sleeve rim)67。圆柱形套筒66是薄壁的使得它可弹性地伸缩自如地从未弯曲的圆柱形横截面变形到稍微变形的椭圆形横截面。圆柱形套筒66具有正好相反的一对纵向导向的一端闭合的瘦长的细缝(diametric pair of longitudinal directed closedend elongated slits)68，细缝68从横向的液体瓶转接器顶壁61延伸到前套筒边缘67。前套筒边缘67具有正好相反的一对向内导向的钩状部件(diametric pair of inwarddirected hook members)69，向内导向的钩状部件69与该正好相反的一对纵向导向的一端闭合的瘦长的细缝68对齐。
药瓶转接器80包括横向的药瓶转接器顶壁81，药瓶转接器顶壁81具有直立的母连接头82和用于伸缩的安装在药瓶20上的相反导向的药瓶转接器裙83。母连接头82优选地是母鲁尔接头(female Luer connector)。药瓶转接器80进一步包括药瓶瓶塞刺穿套管84用于当将药瓶转接器80伸缩地安装在药瓶20上时刺穿药瓶瓶塞24。直立的母连接头82与药瓶瓶塞刺穿套管84流体连通。直立的母连接头82适合无针可擦拭的自动密封的入口阀(needle free swabable self-closing access valve)86，在无针可擦拭的自动密封的入口阀86中密封***公连接头时，无针可擦拭的自动密封的入口阀86从未按压的正常的闭合状态到按压的流体连通状态选择性地可按压。无针可擦拭的自动密封的入口阀86包括可擦拭的预撕裂的进入面(swabable pre-slit access surface)87。
直立的母连接头82由正好相反的一对纵向导向的轨道88组成，每个具有较高的轨道边缘89和较低的轨道边缘91。纵向导向的轨道88比限制环48的高度稍微长。纵向导向的轨道88从它们较高的轨道边缘89到它们较低的轨道边缘91偏离使得较低的轨道边缘91相比较高的轨道边缘89进一步远离纵向的双瓶转接器组件中心线51。直立的母连接头82由在邻近横向的药瓶转接器顶壁81的较低的轨道边缘91的下方的正好相反的一对水平销槽(horizontal recesses)92组成。直立的母连接头82由在水平销槽92每一侧的倾斜的逃逸坡道(sloping escape ramps)93组成使得液体瓶转接器60相对于药瓶转接器80的手动旋转从水平销槽92释放向内导向的钩状部件69并且使得它们骑在一个倾斜的逃逸坡道93上以使前者60与后者80分开一定距离。
图4C显示了流体控制装置52A在它的扩展安装位置，具有部署在较高的轨道边缘89的正好相反的一对向内导向的钩状部件69用于使药瓶转接器80与液体瓶转接器60分开一定距离使得自动密封的入口阀86在它的正常关闭状态适合长期储存。公连接头62接触可擦拭的预撕裂的进入面87，但是没有打开自动密封的入口阀86。双瓶转接器组件50A具有初始扩展安装位置高度H1。
图4D显示了在朝向药瓶转接器80线性压紧液体瓶转接器60之后，流体控制装置52A在它的中间压紧流体连通位置。向内导向的钩状部件88沿着纵向导向的轨道88被向下推动，并且越过较低的轨道边缘91卡扣进入水平销槽92，从而保证液体瓶转接器60与药瓶转接器80安全啮合。同时，公连接头62被***到母连接头82中以打开自动密封的入口阀86用于使液体能够从液体瓶30流到药瓶20用于液体药物形成的目的。双瓶转接器组件50A具有中间压紧流体连通位置高度H2，其中H2<H1。
流体控制装置52A具有最后拆开位置用于在液体瓶转接器60相对于药瓶转接器80顺时针或逆时针旋转时实现液体瓶转接器60从药瓶转接器80的拆开，从而暴露自动密封的入口阀86。液体瓶转接器60从药瓶转接器80的此类释放涉及薄壁的圆柱形套筒66从它的未弯曲的圆柱形横截面到它的弯曲的椭圆形横截面的轻微的弹性变形。液体瓶转接器60相对于药瓶转接器80的手动旋转从水平销槽92释放向内导向的钩状部件69并且使得它们骑在一个倾斜的逃逸坡度93上以使前者60与后者80分开一定距离。自动密封的入口阀86恢复到它的正常闭合状态，呈现了可擦拭的预撕裂的进入面87。
图5到图11显示了吸塑装置40，双瓶转接器组件50A和在负压下的药瓶20的使用。双瓶转接器组件50A可以在没有吸塑装置40和药瓶20不在负压下的情况下同样使用。
图5A和图5B显示了包含在吸塑装置40中的双瓶转接器组件50A和液体瓶30。双瓶转接器组件50A在它的初始扩展安装位置，具有初始扩展安装位置高度H1。
图6A和图6B显示了接触液体瓶30的液体瓶转接器60。
图7A和图7B显示了由箭头A所示的作用于吸塑装置40的手动的线性的按压力(compaction force)用于将液体瓶转接器60推向在液体瓶30，但是刚性的限制环48阻止液体瓶转接器裙63打开。手动的线性的按压力沿着正好相反的一对纵向的轨道88推动向内导向的钩状部件69当薄壁的圆柱形套筒66发生弹性形变时，越过较低的轨道边缘91进入正好相反的一对水平销槽92中。公连接头62被***到母连接头82中以充分地纵向地按压自动密封的进入阀86到它的流体连通状态用于实现液体瓶瓶塞刺穿套管64和药瓶瓶塞刺穿套管84之间的流体连通。液体瓶转接器60通过限制环48。双瓶转接器组件50A具有中间压紧流体连通位置高度H2，其中H2<H1。
图8A和图8B显示了连续的线性的手动的按压力进一步将液体瓶转接器60推向液瓶30使得液体瓶转接器60卡扣在液瓶30上，从而刺穿它的液体瓶瓶塞34。
图9A和图9B显示了双瓶转接器组件50A从吸塑装置40中取出并且颠倒双瓶转接器组件50A用于将药瓶转接器80放置在药瓶20上，而不刺穿药瓶20。
图10A和图10B显示了由箭头B所示在作用液体瓶30上的手动的线性的按压力用于将药瓶转接器80推向药瓶20用于刺穿药瓶20。在负压下的药瓶20将液体瓶30中的液体内含物抽取到药瓶20中用于在药瓶20中形成液体药物内含物95。现在，液体瓶30是空的并且现在药瓶20包含液体药物内含物95。
图11A和图11B显示了在通过液体瓶转接器60相对于液体瓶30的顺时针或逆时针旋转(如图10A中箭头C所示)从药瓶转接器80拆开液体瓶转接器60和空的液体瓶30之后，药瓶转接器80准备用于注射器抽取药瓶20中的液体药物95。
图12和图13显示了双瓶转接器组件50B，其具有类似于双瓶转接器组件50A的构造和操作，因此，类似的部件做了同样编号。后者50B不同前者50A之处在于后者50B具有手动可操作的流体控制装置52B，手动可操作的流体控制装置52B具有四个等间隔的纵向地导向的弹性地挠性支撑物(equispaced longitudinally directed resiliently flexiblesupports)71，每个具有向内导向的钩状部件69。因此，手动可操作的流体控制装置52B具有相应数目的纵向导向的轨道82，每个具有它的较高的轨道边缘89、较低的轨道边缘91和水平销槽92。
图14到图17显示了双瓶转接器组件50C，其具有类似于双瓶转接器组件50A的构造和操作，因此，类似的部件做了同样编号。后者50C不同前者50A之处在于后者50C具有呈卡销装置形式的手动可操作的流体控制装置52C，手动可操作的流体控制装置52C包括至少一个销和销槽对并且优选正好相反的一对销和销槽对。在经受与线性压紧相反的转动压紧时，流体控制装置52C从初始扩展安装位置被推到中间压紧流体连通位置。
液体瓶转接器60是由具有正好相反的一对Y形销槽72的直立的圆柱形套筒66组成。每个大致的Y形的销槽72包括第一闭合端73、与第一闭合端73相反的第二闭合端74和与闭合端73相邻的开放端76。药瓶转接器80是由包围母连接头82的直立的圆柱形套筒96组成。直立的圆柱形套筒96被设计形状和尺寸用以当将双瓶转接器组件50C从它的初始扩展安装位置配置到它的中间压紧流体连通位置时伸缩地被接收在直立的圆柱形套筒66中。直立的圆柱形套筒96是由正好相反的一对向外导向的销97组成用于沿着Y形销槽72滑动。销97在初始扩展安装位置位于第一闭合端73，在中间压紧流体连通位置，位于第二闭合端74，在拆开位置，位于开放端76。
流体控制装置52C具有以下3个位置：
图16A和图16B显示了初始扩展安装位置，其中双瓶转接器组件50C具有初始扩展安装位置高度H1。液体瓶转接器60啮合药瓶转接器80，公连接头62没有被***到母连接头82中使得自动密封的入口阀86保持关闭。销97位于第一闭合端73。
图17A和图17B显示了中间压紧流体连通位置，其中双瓶转接器组件50C具有中间压紧流体连通位置高度H2。液体瓶转接器60啮合药瓶转接器80用于将公连接头62推入到母连接头82中以纵向地按压自动密封的入口阀86以打开入口阀86。在围绕纵向的双瓶转接器组件中心线51相对于固定的药瓶转接器80顺时针旋转(如图14中的箭头D所示)液体瓶转接器60之后，销97位于第二闭合端74。
最后拆开位置用于实现在围绕纵向的双瓶转接器组件中心线51相对于药瓶转接器80逆时针旋转(如图17A中的箭头E所示)液体瓶转接器60时液体瓶转接器60从药瓶转接器80的拆开。销97位于开放端76用于拆开目的。
图18和图19显示了在构造和操作上类似于双瓶转接器组件50C的双瓶转接器组件50D，因此，类似的部件做了同样编号。流体控制装置52D在经受与线性压紧相反的转动压紧时还从初始扩展安装位置被推到中间压紧流体连通位置。双瓶转接器组件50D具有手动可操作的流体控制装置52D，其不同于手动可操作的流体控制装置52C之处在于后者50D包括正好相反的一对反向的倾斜的大致U形销槽77，而不是正好相反的一对Y形销槽72。每个反向的倾斜的大致U形销槽77包括闭合端78、开放端79和在闭合端78和开放端79之间的弯曲的尖端81。销97在初始扩展安装位置位于闭合端78，在中间压紧流体连通位置，位于弯曲的尖端81以及在最后拆开位置，位于开口端79。
虽然本发明的详细实施方案被说明了且被描述了，对于本领域技术人员来说，在不脱离本发明的精神和范围的前提下，可以做出各种其它的变化和修改是显而易见的。

Claims (12)

1.与无针注射器、药瓶和液体瓶一起使用的双瓶转接器组件，所述无针注射器包括公连接头，所述药瓶包括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，所述液体瓶包括液体瓶瓶体和配置为密封所述液体瓶瓶体的液体瓶瓶塞，所述液体瓶包含液体内含物用于在所述药瓶中混合或重构所述药剂以在其中形成液体药物内含物，所述双瓶转接器组件具有纵向的双瓶转接器组件中心线并且包括：
(a)药瓶转接器，所述药瓶转接器设置有横向的药瓶转接器顶壁，直立的母连接头，用于伸缩的安装在所述药瓶上的相反的导向的药瓶转接器裙，药瓶瓶塞刺穿套管，所述药瓶瓶塞刺穿套管配置为当将所述药瓶转接器所述伸缩地安装在所述药瓶上时刺穿药瓶瓶塞，以及较高的轨道边缘，所述直立的母连接头与所述药瓶瓶塞刺穿套管流体连通，所述直立的母连接头包括无针可擦拭的自动密封的入口阀，当将公连接头密封地***所述入口阀时所述无针可擦拭的自动密封的入口阀从未按压的正常的关闭状态到经按压的开放的流体连通状态选择性地纵向可按压；和
(b)液体瓶转接器，所述液体瓶转接器设置有横向的液体瓶转接器顶壁、直立的公连接头，用于伸缩的安装在所述液体瓶上的相反导向的液体瓶转接器裙，液体瓶瓶塞刺穿套管，所述液体瓶瓶塞刺穿套管用于当将所述液体瓶转接器所述伸缩地安装在所述液体瓶上时刺穿所述液体瓶瓶塞，以及正好相反的一对向内导向的钩状部件，所述直立的公连接头与所述液体瓶瓶塞刺穿套管流体连通；其特征在于，
所述药瓶转接器和所述液体瓶转接器在手动可操作的流体控制装置中在操作位置是可组合的，所述操作位置包括：
i)压紧流体连通位置，其中所述液体瓶转接器啮合所述药瓶转接器，其中所述公连接头被推入到所述直立的母连接头中以纵向地按压所述无针可擦拭的自动密封的入口阀到所述按压的开放的流体连通状态，用于实现所述药瓶瓶塞刺穿套管和所述液体瓶瓶塞刺穿套管之间的流体连通，用来能够在所述药瓶中形成液体药物内含物，以及其中，所述双瓶转接器组件具有压紧流体连通位置高度H2，
ii)最后拆开位置，用于实现所述液体瓶转接器从所述药瓶转接器的拆开，从而提供到所述无针可擦拭的自动密封的入口阀的可重复的进入，用于抽取所述药瓶中的液体药物内含物，以及
iii)初始扩展安装位置，其中所述液体瓶转接器啮合所述药瓶转接器，所述公连接头没有***到所述直立的母连接头中，从而所述无针可擦拭的自动密封的入口阀被关闭，并且，其中所述双瓶转接器组件具有初始扩展安装位置高度H1，其中H2<H1，从而所述压紧流体连通位置是在所述初始扩展安装位置和所述最后拆开位置之间的中间压紧流体连通位置，以及其中，在初始扩展安装位置，所述正好相反的一对向内导向的钩状部件被固定在所述横向的药瓶转接器顶壁和所述较高的轨道边缘之间的所述较高的轨道边缘，以使所述液体瓶转接器与药瓶转接器保持距离，从而使所述公连接头与无针可擦拭的自动密封的入口阀接触，无需对其进行纵向按压。
2.根据权利要求1所述的双瓶转接器组件，其中所述手动可操作的流体控制装置经受从所述初始扩展安装位置到所述压紧流体连通位置的线性按压用于将所述公连接头推入到所述直立的母连接头中。
3.根据权利要求2所述的双瓶转接器组件，其中所述液体瓶转接器包括至少一个向内导向的钩状部件用于在所述线性压紧期间沿着所述药瓶转接器上的相关的纵向的轨道向下滑动。
4.根据权利要求3所述的双瓶转接器组件，其中所述液体瓶转接器包括围绕所述公连接头的直立的圆柱形套筒并且所述直立的圆柱形套筒形成为具有所述至少一个向内导向的钩状部件。
5.根据权利要求2到4任一项所述的双瓶转接器组件，并且进一步包括用于盛放所述双瓶转接器组件的吸塑装置，所述吸塑装置包括顶部开口的吸塑装置包装，所述顶部开口的吸塑装置包装包括吸塑容器闭合端和吸塑容器开放端，所述吸塑容器开放端具有内部刚性限制装置用于防止在将所述液体瓶转接器所述伸缩地安装在所述液体瓶上时所述液体瓶转接器立即卡扣在所述液体瓶上使得所述伸缩地安装初始地推动所述流体控制装置从所述初始扩展安装位置到所述中间压紧流体连通位置。
6.根据权利要求1所述的双瓶转接器组件，其中所述手动可操作的流体控制装置经受从所述初始扩展安装位置到所述压紧流体连通位置的转动的压紧，用于将所述公连接头推入到所述直立的母连接头中。
7.根据权利要求6所述的双瓶转接器组件，其中所述手动可操作的流体控制装置是卡销装置，所述卡销装置具有至少一个销销槽对，其中销沿着相关的大致的Y形销槽从在所述初始扩展安装位置的第一闭合端行进到在所述中间压紧流体连通位置的与所述第一闭合端相反的第二闭合端，并且从在所述中间压紧流体连通位置的所述第二闭合端行进到在所述最后拆开位置的开放端。
8.根据权利要求6所述的双瓶转接器组件，其中所述手动可操作的流体控制装置是卡销装置，所述卡销装置具有至少一个销销槽对，其中销沿着相关的反向的倾斜的大致U形销槽从在所述初始扩展安装位置的第一闭合端行进到在所述中间压紧流体连通位置的弯曲的尖端，并且从在所述中间压紧流体连通位置的所述弯曲的尖端行进到在所述最后拆开位置的开放端。
9.根据权利要求1-4和6-8任一项所述的双瓶转接器组件，其中所述手动可操作的流体控制装置利用所述液体瓶转接器相对于所述药瓶转接器的手动旋转用于在所述最终拆开位置分开所述液体瓶转接器与所述药瓶转接器。
10.根据权利要求1-4和6-8任一项所述的双瓶转接器组件，其中所述药瓶转接器进一步包括较低的轨道边缘和位于所述较低的轨道边缘和所述较高的轨道边缘之间的正好相反的一对纵向导向的轨道。
11.根据权利要求10所述的双瓶转接器组件，其中，所述正好相反的一对纵向导向的轨道从所述较高的轨道边缘到所述较低的轨道边缘偏离使得所述正好相反的一对纵向导向的轨道比所述较高的轨道边缘进一步远离所述纵向的双瓶转接器组件中心线。
12.根据权利要求11所述的双瓶转接器组件，其中，在所述初始扩展安装位置，所述正好相反的一对向内导向的钩状部件部署在所述较高的轨道边缘与所述纵向导向的轨道之间的连接点处的所述较高的轨道边缘以使所述液体瓶转接器无需纵向地按压就与所述药瓶转接器分开一定距离使得所述公连接头接触所述无针可擦拭的自动密封的入口阀。
CN202211280101.XA 2015-11-25 2016-11-24 包括具有自动密封的入口阀的药瓶转接器的双瓶转接器组件 Pending CN115721558A (zh)

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IL242776A IL242776A0 (en) 2015-11-25 2015-11-25 The device with two vial adapters includes a drug vial adapter with a self-sealing access valve
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IL245641 2016-05-15
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BR112018010435A2 (pt) 2018-11-21
WO2017090042A1 (en) 2017-06-01
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IL258920A (en) 2018-06-28
BR112018010435B1 (pt) 2022-06-28
EP3380058B1 (en) 2020-01-08
US10278897B2 (en) 2019-05-07
EP3380058A1 (en) 2018-10-03
CN108366905A (zh) 2018-08-03
IL258920B (en) 2021-06-30

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