CN104703574A - 利用用于双流体连通步骤致动的手动旋转的液体药物转移装置 - Google Patents

利用用于双流体连通步骤致动的手动旋转的液体药物转移装置 Download PDF

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CN104703574A
CN104703574A CN201380044528.2A CN201380044528A CN104703574A CN 104703574 A CN104703574 A CN 104703574A CN 201380044528 A CN201380044528 A CN 201380044528A CN 104703574 A CN104703574 A CN 104703574A
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尼姆罗德·列费
尼温·本·肖隆
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Abstract

液体药物转移装置，该液体药物转移装置利用用于双流体连通步骤致动的相对于液体容器转接器的药瓶转接器的手动旋转建立含有液体内含物的液体容器与初始未开启的(即未被穿刺的)药瓶之间的流体连通。沿纵向装置轴手动旋转按压液体药物转移装置用于在药瓶流体连通步骤期间推动刺穿尖端通过药瓶塞子以与药瓶内部流体连通。手动旋转还执行液体容器流体连通步骤以与液体容器流体连通，因此建立药瓶与液体容器之间的流体连通。

Description

利用用于双流体连通步骤致动的手动旋转的液体药物转移装置
技术领域
本发明涉及用于混合、重构以及给药目的的液体药物转移装置。
背景技术
发明名称为与液体容器和小瓶一起使用的阀门组件，并且以PCT国际公开号WO2013/054323公开的共同拥有的PCT国际申请号PCT/IL2012/000354公开了与输液液体容器和药瓶一起使用的阀门组件。该阀门组件包括传统的公药瓶转接器，该公药瓶转接器具有与用于刺穿药瓶塞子的穿刺部件流体连通的公接头。该阀门组件还包括用于连接到输液液体容器的进入口的进入口转接器和用于密封地安装在公接头上的母接头。该阀门组件的使用包括几个用户操作，该用户操作尤其包括将阀门组件连接到进入口，将阀门组件伸缩地夹在药瓶上，和打开阀门组件用于使输液液体能够流入到药瓶中用于混合或重构目的和随后的从药瓶到输液液体容器的液体内含物的转移用于随后的给药。
Zinger等共同拥有的发明名称为流体转移装置的美国专利号6,558,365公开了用于无菌重构药物药剂以实现给药目的的液体药物转移装置。该液体药物转移装置包括所谓的母药瓶转接器和预安装在母药瓶转接器上的所谓的公液体瓶转接器。该母药瓶转接器被打算通常在负压下伸缩地夹在含有药物药剂的药瓶上。该公液体瓶转接器被打算伸缩地夹在仅仅含有稀释剂或含有将要通过其负压被吸入到药瓶中的活性液体成分的液体瓶上。该液体药物转移装置的使用涉及几个用户操作，该用户操作尤其包括用户将液体瓶转接器伸缩地夹在液体瓶上，将液体药物转移装置和液体瓶倒置，和将药瓶转接器伸缩地夹在药瓶上。
上述液体药物转移装置需要几个用户操作，该用户操作可能是耗时的并且易于出错，例如不准确地将药瓶转接器伸缩地夹在药瓶上会导致药瓶不能使用。需要改进的液体药物转移装置，其要求较少的用于致动目的用户操作，从而方便用户并且减少药瓶的损耗。
发明内容
本发明针对的是液体药物转移装置，该液体药物转移装置利用用于双流体连通步骤致动的手动旋转建立含有液体内含物的液体容器与含有药物药剂的初始地未开启(即没有被穿刺)的药瓶之间的流体连通。该液体容器可以是输液液体容器或液体瓶。输液液体容器尤其包括瓶子、静脉注射袋等。液体瓶可仅仅含有稀释剂或活性液体成分。药瓶包含粉末状的药物药剂或液体药物药剂。一些药瓶是负压的。
该液体药物转移装置具有纵向的装置轴，并且包括用于连接到液体容器上的液体容器转接器、双末端液体转移部件和用于伸缩地夹在药瓶上的药瓶转接器。该双末端液体转移部件具有终止在穿刺尖端的后液体转移部件末端，该穿刺尖端与纵向的装置轴同方向，并且初始地与初始未开启的药瓶的最上药瓶表面间隔一定距离。该液体药物转移装置被设计使得围绕纵向装置轴的手动旋转线性地沿该装置轴按压液体药物转移装置，用于在药瓶流体连通步骤期间沿线性位移推动穿刺尖以刺穿通过药瓶塞子用于与药瓶内部流体连通。
液体药物转移装置可被设计使得根据手边的临床应用，药瓶流体连通步骤是两个流体连通步骤致动的第一流体连通步骤或第二流体连通步骤。包括初始药瓶流体连通步骤和随后液体容器流体连通步骤的两个流体连通步骤致动提供液体内含物可直接从液体容器流向药瓶的优势。在药瓶负压被用于将液体内含物从液体瓶抽吸到药瓶中用于混合或重构目的(类似于Zinger等的美国专利号6,558,365所提到的方式)的情况下，包括初始液体容器流体连通步骤和随后药瓶流体连通步骤的两个流体连通步骤致动是必需的。
液体药物转移装置可利用不同的机械布置将手动转动转换成线性位移用于药瓶穿刺目的。合适的机械布置尤其包括螺纹布置、销和轨道布置(pin and track arrangement)等。一些液体药物转移装置利用相同的机械布置用于它们的药瓶流体连通步骤和它们的液体容器流体连通步骤。其它的液体药物装置利用一个机械布置用于它们的药瓶流体连通步骤，并且利用另一个机械配置用于它们的液体容器流体连通步骤。机械布置的选择是不同设计特征的函数以平衡要求的旋转数目和用户使用的转矩以影响手动旋转。旋转的数目越多，要求的转矩越小，反之亦然。
依据想要的液体容器，本发明的液体药物转移装置可被划分为如下两种类型中的一种：输液液体容器类型和液体瓶类型。
在输液液体容器类型中，液体容器转接器由通常呈注入口转接器形式的进入口转接器构成。双末端液体容器转移部件可终止在进入口流体部件，该进入口流体部件与纵向的装置轴同方向，并且初始地与输液液体容器的进入口分开一定距离用于在液体容器流体连通步骤期间沿纵向装置轴的随后推动以滑动插入到进入口中。或者，进入口转接器可包括进入口流体部件用于当将进入口转接器连接到输液液体容器上时插入到进入口中，双末端液体转移装置可终止在输液液体容器活塞布置用于选择性地打开和关闭与进入口流体部件的流体连通。
在液体瓶类型中，液体容器转接器是由类似于药瓶转接器的液体瓶转接器构成。前液体转移部件末端也终止在穿刺尖端，该穿刺尖端与纵向的装置轴同方向，并且初始地与初始未开启的液体瓶的最上液体瓶表面分开一定距离用于在液体瓶连通步骤期间沿纵向装置轴的随后推动以刺穿液体瓶塞子用于与液体瓶内部流体连通。而且，该双末端液体转移部件优选地具有包括药瓶构件(drug vial component)和液体瓶构件(liquid vial component)的双构件结构(dual component construction)。该药瓶构件优选终止在用于随后从药瓶抽吸液药物内含物的接头中。该接头优选地是母接头。根据液体瓶和药瓶之间的流体连通，液体转移部件的液体瓶构件被打算从其对应的药瓶构件上拆除使得该两个构件保持连接到它们各自的小瓶转接器。
假如它们至少配备有预连接的未开启的药瓶，该液体药物转移装置优选地提供为所谓的“马上可以使用的”医疗装置。该液体药物转移装置还另外配备有预连接的液体容器，该液体容器是预连接的输液液体容器或预连接的未开启的液体瓶。每个预连接代替用户连接，因此利于用户方便，尤其是排除不正确地将小瓶转接器伸缩地夹在药瓶上。此外，马上可以使用的医疗装置减少药物浪费，因为它们方便了使用之前的在患者床边的准备工作，这与远离患者床边在药物配药室(compound pharmacy)中的远程准备工作不同，远程准备工作可能造成不使用的药物。
预连接的未开启的药瓶可被夹在用于在它们的未开启状态能够通过释放工具拆除的药瓶转接器中，例如在患者不再需要药物药剂的情况下。该释放的未开启的药瓶被放在可控的环境中用于储存目的以及重新连接到液体药物转移装置用于随后的给予。或者，预连接的药瓶可被夹在防止它们拆除的药瓶转接器中。再次，液体药物转移装置可不配备预连接的药瓶和/或预连接的液体容器，从而要求用户将液体药物转移装置连接到药瓶和液体容器上。
一些液体药物转移装置可包括用于伸缩地夹在单一尺寸的药瓶(即小药瓶或大药瓶)上的常规药瓶转接器。或者，液体药物转移装置可视需要包括通用药瓶转接器，其被设计用于同样地伸缩地夹在小药瓶和大药瓶的药瓶上。2013年8月25日提交的发明名称为液体药物转移装置的共同拥有的PCT国际申请号PCT/IL2013/050706阐明和记载了合适的通用药瓶转接器。该液体药物转移装置同样地包括用于伸缩地夹在单一尺寸的液体瓶上的常规液体瓶转接器或通用液体瓶转接器。
一些液体药物转移装置可优选地配备有用户指示用于指示液体容器与药瓶之间的流体连通的建立。用户指示可呈视觉指示和/或声音指示的形式，例如滴答声。
附图说明
为了理解本发明且看清楚如何在实践中实施它，仅仅借助非限制性实施例，参照附图描述优选的实施例，附图中相同的部分采用了同样的编号，并且其中：
图1是根据本发明的第一优选实施例的液体药物转移装置在初始预致动状态、小药瓶、大药瓶以及静脉注射袋的前透视图；
图2是图1的液体药物转移装置的分解图；
图3A是图1的液体药物转移装置在手动旋转之前，在预致动状态的正视图；
图3B是图1的液体药物转移装置沿图3A中的A-A线的纵向截面图；
图4A是图1的液体药物转移装置，根据手动旋转执行药瓶流体连通步骤，在中间的致动状态的正视图；
图4B是图1的液体药物转移装置沿图4A中的B-B线的纵向截面图；
图5A是图1的液体药物转移装置，根据手动旋转随后执行它的液体容器流体连通步骤，在它的致动后的状态的正视图；
图5B是液体药物转移装置沿图5A中C-C线的纵向截面图；
图6A到6E显示带有预连接小药瓶的图1的液体药物转移装置用于将药瓶药剂引到静脉注射袋中以及给予输液液体内含物；
图6C是图6B沿其上D-D线的纵向截面图；
图7A是根据本发明的第二优选实施例的液体药物转移装置在预致动状态的前透视图；
图7B是图7A的液体药物转移装置沿其上E-E线的纵向截面图；
图8是根据本发明的第三优选实施例的液体药物转移装置在预致动状态的前透视图；
图9是图8的液体药物转移装置的分解图；
图10A是图8的液体药物转移装置在它的预致动状态包括关闭的活塞位置的右侧正视图；
图10B是图8的液体药物转移装置沿图10A中的F-F线的纵向截面图；
图11A是图8的液体药物转移装置，根据手动旋转执行液体容器流体连通步骤，在中间的致动状态包括敞开的活塞位置的正视图；
图11B是图8的液体药物转移装置沿图11A中的G-G线的纵向截面图；
图12A是根据手动旋转执行药瓶流体连通步骤，图8的液体药物转移装置在其致动后的状态的正视图；
图12B是图8的液体药物转移装置沿图12A中的H-H线的纵向截面图；
图13A是图8的液体药物转移装置在手动旋转的上锁步骤中的正视图；
图13B是图8的液体药物转移装置沿图13A中的I-I线的纵向截面图；
图14A是根据手动相反旋转图8的液体药物转移装置在关闭的活塞位置的正视图；
图14B是图8的液体药物转移装置沿图14A中的J-J线的纵向截面图；
图15是根据本发明的第四优选实施例的液体药物转移装置在预致动状态的前透视图；
图16是图15的液体药物转移装置包括其双末端液体转移部件的分解图；
图17是图15的液体药物转移装置沿其上的K2-K2线的纵向截面图；
图18是图16的液体转移部件的特写图；
图19A是沿图15中K1-K1线的特写横截面图，显示带有一对较小止动元件(stop)的药瓶转接器杆(drug vial adapter stem)，用于保持液体转移部件在其预致动状态；
图19B是沿图15中K2-K2线的特写横截面图，显示带有一对较大的止动部件(stop)的药瓶转接器杆(drug vial adapter stem)，用于保持液体转移部件在其预致动状态；
图20A是图15的液体药物转移装置在预致动状态连接到注入口和大药瓶的正视图；
图20B是图20A的液体药物转移装置沿其上的L-L线的纵向截面图；
图21A是根据液体容器流体连通步骤，图20A的组合件在中间致动状态的正视图；
图21B是图21A的组合件沿其上的M-M线的纵向截面图；
图22A是图20A的组合件在致动后的状态的正视图；
图22B是图22A的组合件沿其上N-N线的纵向截面图；
图23是根据本发明的第五优选实施例的液体药物转移装置在预致动状态、大药瓶和无针注射器的前透视图；
图24是图23的液体药物转移装置沿其上P-P线的纵向截面图；
图25是图23的液体药物转移装置的分解图；
图26A是连接到大药瓶在预致动状态的图23的液体药物转移装置和大药瓶的正视图；
图26是图26A的组合件沿其上的Q-Q线的纵向截面图；
图27A是根据液体容器流体连通步骤，图26A的组合件在中间的致动状态的正视图；
图27B是图27A的液体药物转移装置沿其上R-R线的纵向截面图；
图28A是根据药瓶流体连通步骤，图26A的组合件在致动后的状态的正视图；
图28B是图28A的组合合件沿其上S-S线的纵向截面图；
图29A是显示液体瓶转接器和药瓶转接器分离的正视图；
图29B是图29A的液体瓶转接器和药瓶转接器沿其上T-T线的纵向截面图；
图30A是从药瓶中注射器抽吸液体药物内含物的正视图；以及
图30B是图30A的组合件沿其上U-U线的纵向截面图；
本发明优选实施例的详细描述
图1到图14显示与小药瓶20A和大药瓶20B的药瓶20和由被描述成静脉注射(IV)袋40的输液液体容器构成的液体容器一起使用的三个液体药物转移装置100,200和300。该液体药物转移装置100,200和300相似之处在于它们的每一个都具有纵向的器械轴101并且包括由进入口转接器构成的液体容器转接器102，液体转移部件103和由通用药瓶转接器构成的药瓶转接器104。它们的进入口转接器102的每一个都具有前进入口转接器末端102A和后进入口转接器末端102B。它们的液体转移部件103的每一个都具有前液体转移部件末端103A和后液体转移部件末端103B，该前液体转移部件末端103A朝向用于啮合它的进入口转接器102设置，该后液体转移部件末端103B朝向用于啮合它的药瓶转接器104设置。
药瓶20具有纵向的药瓶轴21并且包括具有药瓶底部23的药瓶瓶体22，限定药瓶开口26的药瓶头部24，和在药瓶瓶体22与药瓶头部24之间的窄直径药瓶颈部27。药瓶20具有用于储存粉末状或液体药剂29的药瓶内部28。药瓶20由插到药瓶开口26中的药瓶塞子31密封。药瓶20具有最上药瓶表面32。药瓶头部24通常由药瓶封闭物33(例如，铝带等)密封。
大药瓶具有与小药瓶同样的形状但是，具有成比例的较大规格。尤其是，大药瓶比它们对应的小药瓶具有更宽直径的药瓶封闭物和药瓶颈部。市场上广泛销售的小药瓶20A具有外径D1在13mm和14mm之间的药瓶封闭物33，市场上广泛销售的大药瓶20B具有外径D2通常在20mm和21mm之间的药瓶封闭物33，D2>D1。本发明同样适用于较大的所谓的小药瓶和含有较大液体容量的所谓的大药瓶，例如分别为直径是28mm的药瓶封闭物和直径是32mm的药瓶封闭物。
静脉注射袋40包括两种类型的进入口，即注入口(injection port)41和给药口(administration port)42，并且含有液体内含物43。静脉注射袋开口41和42呈塑料管形式。注入口41终止在含有自密封塞(plug)46的注入口小端(injection port tip)44中，该密封塞46带有准备用于注射器内含物针头注入到静脉注射袋40中的暴露的塞表面47。该注入口小端44具有后注入口小端边缘48。给药口42通常由拧开帽(twist offcap)49密封，用于插入静脉注射尖状物以实现给药目的。
液体药物转移装置100、200和300被阐明和描述了用于连接到注入口41上，并且可同样地被实施用于连接到给药口42上。
更具体的是，图1到图7显示液体药物转移装置100包括注入口转接器102，该注入口转接器102借助螺纹机械布置啮合前液体转移部件末端103A，后液体转移部件末端103B借助销钉和轨道机械布置啮合通用药瓶转接器104。液体药物转移装置100利用手动旋转执行用于建立液体转移部件103和药瓶20之间的流体连通的初始药瓶流体连通步骤，和用于以建立液体转移部件103和静脉注射袋40之间的流体连通，从而建立药瓶20和静脉注射袋40之间的流体连通的随后液体容器流体连通步骤。
注入口转接器102具有与前注入口凹槽(leading injection port recess)107一起成形的管状外壳106，该前注入口凹槽107带有横向的注入口凹槽壁108，该横向的注入口凹槽壁108带有限定贯穿注入口凹槽壁孔109的内部注入口凹槽壁边缘108A。优选地，前注入口凹槽107设置有用于连接到注入口41上的通用注入口连接头111，这在2013年8月20日提交的发明名称为液体药物转移装置的共同拥有的PCT国际申请号PCT/IL2013/050706中也有所阐明和记载。
外壳106具有内表面112，该内表面112配备有前横向的向内指向的环形桥礅肋(leading transverse inward directed annular abutment rib)113A和后横向的向内定向的环形桥礅肋113B，用于控制液体转移部件103的位移。内表面112与导向肋114一起形成，该导向肋114朝向后注入口转接器末端102B，用于朝向注入口转接器102线性按压通用药瓶转接器104期间的导向目的。外壳106与贯穿狭缝(throughgoing slot)116一起形成，该贯穿狭缝116朝向前注入口转接器末端102A以能够可视化用户指示静脉注射袋和药瓶之间的流体连通的建立。
前液体转移部件末端103A配备有带有进入口流体部件118的液体转移部件头部117，该进入口流体部件118由用于针头插入到注入口41中的针头构成。液体转移部件头部117在液体药物转移装置100的预致动状态中被布置在桥礅肋113A上。液体转移部件103包括套管118A，该套管118A用于初始地覆盖针118以保证针头118保持无菌直到它刺穿注入口41。液体转移部件头部117具有外部鲜亮地着色的表面用于提供在执行手动旋转以建立静脉注射袋40和药瓶20之间的流通连通时通过贯穿狭缝116的可视化用户指示。
后液体转移部件末端103B终止在用于刺穿药瓶塞子31的刺穿尖端(puncturing tip)119。液体转移部件103包括套管121，该套管121用于初始地覆盖刺穿尖端119以保证刺穿尖端119保持无菌直到它刺穿药瓶塞子31。套管121包括具有形状和规格用于放置在最上药瓶表面32上的圆形底部122。液体转移部件103与用于针头118和刺穿尖端119之间的流通连通的轴向的内腔123一起形成。
前液体转移部件末端103A具有液体转移部件头部钻头样部分124用于在顺时针拧紧方向围绕纵向的装置轴101手动旋转药瓶转接器104时螺纹啮合桥墩肋113A以使针头118针头插入到注入口41中。钻头样部分124包括后止动部件(trailing stop member)126，该后止动部件126用于紧靠桥墩肋113B停止以使液体转移部件103朝向注入口转接器102的线性位移停止。后液体转移部件末端103B与一对向外指向的径向的插销128一起形成，插销128用于使液体转移部件103借助通用药瓶转接器104能够相对于注入口转接器102旋转。
通用药瓶转接器104包括带有内部的顶壁边缘129A的横向的小瓶转接器顶壁129，顶壁边缘129A沿纵向的装置轴101限定贯穿顶壁孔130。通用药瓶转接器104包括用于伸缩地夹在药瓶封闭物33上的向下垂的小瓶转接器裙边131，使得贯穿顶壁孔130覆在最上药瓶表面32上面。小瓶转接器裙边131包括支撑后圆形部件133的四个平均间隔的向下垂的支持物132。圆形部件133与弹性地可弯曲的向上垂的抓柄部件(resilientlyflexible upward depending grip members)134一起形成，该抓柄部件134被划分成第一对相对的抓柄部件134A和134B，和正交的第二对相对的抓柄部件134C和134D。抓柄部件134的每一个与用于抓住药瓶封闭物33的向部指向的抓柄(gripper)136一起形成。
小瓶转接器顶壁129与绕贯穿顶壁孔130的轴向指向的直立管状药瓶转接器杆137和相对的向下垂的小瓶转接器裙边131一起形成。药瓶转接器杆137具有一对相对的大体上螺旋形的轨道138，该轨道138用于由一对向外指向的径向插销128相应啮合。轨道138的每一个具有远离小瓶转接器顶壁129的开始轨道末端139A和邻近小瓶转接器顶壁129的最终轨道末端139B。
液体转移部件103放置在药瓶转接器杆137中使得在液体药物转移装置100的预穿刺状态，它的穿刺尖端119与夹在向下垂的药瓶裙边131中的最初地原封未动的未穿刺的药瓶20的最上药瓶表面32分开。该对向外指向的径向销钉128通常部署在开始轨道末端139A处。在从开始轨道末端139A到最终轨道末端139B移位液体转移部件103时，穿刺尖端119穿过贯穿顶壁孔130用于穿刺通过药瓶塞子31以建立与药瓶内部28的流体连通。
图3A和3B显示液体药物转移装置100在它的预致动状态带有药瓶转接器104，在距注入口转接器102的它的最远的位置。液体药物转移装置100具有预致动高度H1。液体转移部件103被部署在桥墩肋113A处，针头118被部署在贯穿注入口凹槽壁孔109处，准备被推入到前注入口凹槽107中。向外指向的径向销钉128被部署在开始轨道末端139A处，穿刺尖端119被部署在向下垂的小瓶转接器裙边131之上，并且优选地在贯穿顶壁孔130之上。
图4A和4B显示根据相对注入口转接器102围绕纵向的装置轴101在顺时针拧紧方向上手动旋转通用药瓶转接器104执行药瓶流体连通步骤的液体药物转移装置100。手动旋转推动通用药瓶转接器104移向最终轨道末端139B，同时液体转移部件103相对于注入口转接器102保持固定。注入口转接器102与通用药瓶转接器104之间的这种相对线性位移导致穿刺尖端119穿刺药瓶塞子31以建立液体转移部件103与药瓶20之间的流体连通。液体药物转移装置100具有中间致动高度H3，其中H3<H1。
图5A和5B显示根据相对于注入口转接器102继续手动旋转通用药瓶转接器104执行液体容器流体连通步骤的液体药物转移装置100。液体药物转移装置100具有致动后的高度H2，其中H2<H3，因此H2<H1。继续的手动旋转推动液体转移部件103沿桥墩肋113A移动直到后止动部件126紧靠桥墩肋113B停止，使得通用药瓶转接器104邻近注入口转接器102。针头118被推入前注入口凹槽107中用于针头插入注入口41中以建立液体转移部件103与静脉注射袋40，因此与药瓶20之间的流体连通。通过贯穿狭缝116液体转移部件头部117是可视的使得用户意识到液体药物转移装置100现在是处于它的致动状态。
图6A到6E显示带有预连接的药瓶20A的液体药物转移装置100的使用。带有预连接的药瓶20B的液体药物转移装置100的使用和带有预连接的药瓶20A的液体药物转移装置100的使用是一样的。
图6A显示如箭头A所示将液体药物转移装置100连接到静脉注射袋40上用于将注入口41插入到前注入口凹槽以连接到注入口接头上。
图6B显示如箭头B所示，相对注入口转接器102在顺时针拧紧方向上围绕纵向的装置轴101手动旋转通用药瓶转接器104以推动液体药物转移装置100以建立静脉注射袋40与药瓶20A之间的流体连通。通过狭缝116液体转移部件头部117是可视的以指示流体连通。用户如箭头C所述挤压静脉注射袋40用于将液体内含物从静脉注射袋40转移到药瓶20A中用于重构或稀释目的。用户可轻轻地摇动该组合件以保证粉末状内含物完全重构。
图6C显示经由针头118、轴向内腔123和穿刺尖端119的静脉注射袋40与药瓶20A之间的流体连通。
图6D显示将静脉注射袋40、液体药物转移装置100和药瓶20A倒置，并且如箭头D所示将空气从静脉注射袋40中挤压到药瓶20A中用于将液体药物内含物从药瓶20A排入到静脉注射袋40中。
图6E显示将静脉注射袋40、液体药物转移装置100和现在排空的药瓶20A倒置准备用于静脉注射袋液体内含物经由输液器(未显示)的给药。
图7A和7B显示液体药物转移装置200在结构和操作上与液体药物转移装置100相似，因此相似的部分被同样地编号。前者200与后者100的不同之处在于前者200包括带有预连接的不可拆除的药瓶20A的药瓶转接器104。
图8到14显示与液体药物转移装置100相似的液体药物转接装置300用于与药瓶20A和药瓶20B的药瓶20和静脉注射袋40一起使用。前者300与后者100具有大体相似的结构，因此相似部分被同样地编号如下：液体药物转接装置300具有纵向的装置轴101，并且包括注入口转接器102，液体转移部件103和通用药瓶转接器104。
前者300与后者100的不同之处在于前者300利用手动旋转执行用于建立液体转移装置103与输液液体容器之间的流体连通的初始液体容器流体连通步骤和用于建立液体转移装置103与药瓶之间的流体连通，由此建立输液液体容器与药瓶之间的流体连通的随后药瓶流体连通步骤。此外，前者300与后者100的不同之处在于前者300利用手动旋转执行朝向注入口转接器102线性按压药瓶转接器104用于药瓶穿刺，和利用输液液体容器活塞布置(infusion liquid container stopcock arrangement)140的操作选择流体连通注入口转接器102与输液液体容器。
液体药物转接装置300与液体药物转接装置100在如下三个主要方面具有不同的结构：
首先，输液液体容器活塞布置140包括注入口转接器102的前注入口凹槽107，该前注入口凹槽107配备有针头118，而不是流体转移部件103。针头118安装在形成在注入口凹槽壁108中的轴向内腔141中。液体转移部件103和药瓶转接器104具有从纵向的装置轴101偏移的旋转轴142。前液体转移部件末端103A终止在与开口144一起形成的前锥体143中，该开口144与轴向内腔123流体连通。锥体143包括用于沿形成在锥体凹槽149的内侧表面148上的键槽147旋转运动的键146，该锥体凹槽149形成注入口凹槽壁108的一部分用于开口144与轴向内腔141的选择性对齐以能够与针头118流体连通。
输液液体容器活塞布置140具有关闭的流体位置，在该位置中，键146在沿键槽147的第一极限位置处用于使开口144和内腔141不对齐，由此，不能够实现针头118与液体转移部件103的流体连通。输液液体容器活塞布置140具有打开的流体位置，在该位置中，键146在沿键槽147的与第一极限位置相反的第二极限位置用于使开口144与轴向内腔141对齐，用于建立针头118与液体转移部件103的轴向内腔123之间的流体连通。
第二，后液体转移部件末端103B与相对的成对反向大体上L形轨道151，而不是螺旋形轨道138一起形成。轨道151的每一个都具有包括在接合点154汇合的直立的螺旋腿(spiral legs)152和水平腿153。螺旋腿152的每一个都具有与它们的相应接合点154相反的密封的腿末端156。水平腿153的每一个都具有与它们的相应接合点154相反的密封的腿末端157。每个密封的腿末端157与锁定部件(lock features)158一起形成用于锁定它们相应的向外的径向插销128。
为了执行药瓶穿刺目的的药瓶流体连通步骤，密封的腿末端156与开始轨道末端139A相对应，接合点154与最终轨道末端139B相对应。
第三，通用药瓶转接器104具有用于伸缩地夹在药瓶20上的向下垂的裙边131。药瓶转接器裙边131包括用于卡扣在小药瓶20A上的内部小瓶抓柄161和用于卡扣在大药瓶20B上的外部小瓶抓柄162。内部小瓶抓柄161包括两个相对的可弯曲部件(flexmembers)163，每个可弯曲部件与用于卡扣在小药瓶20的药瓶封闭物33上的内部指向的边缘164一起形成。外部小瓶抓柄162围绕内部小瓶抓柄161，并且包括第一对邻近的可弯曲部件166A和166B和与第一对邻近的较大可弯曲部件166A和166B相对的第二对邻近的较大可弯曲部件167A和167B。较大可弯曲部件166和167的每一个都与用于卡扣在的药瓶20B的药瓶封闭物33上的内部指向的边缘168一起形成。
可弯曲部件166A和166B是邻近的。可弯曲部件167A和167B是邻近的。可弯曲部件166A和167A是分开的留有它们之间的间距169A。可弯曲部件166B和167B是分开的留有它们之间的间距169B。可弯曲部件163A和163B相应地与间距169A和169B对齐，由此在将通用药瓶转接器104卡扣在药瓶20A上时，它们的向外弯曲不受可弯曲部件166和167的妨碍。
图10到14显示液体药物转移装置300的使用如下：
图10A和10B显示液体药物转移装置300在它的预致动状态具有预致动高度H1。输液液体容器活塞布置140在关闭的流体位置带有部署在沿键槽147的它的第一极限位置的键146，使得开口144不与轴向内腔141流体连通。向外指向的径向销钉128部署在密封的腿末端156处，使得穿刺尖端119布置成与夹在向下垂的裙边131中的药瓶20的最上药瓶表面32分开。
图11A和11B显示根据由箭头E所示相对注入口转接器102在顺时针拧紧方向上围绕旋转轴142的手动旋转通用药瓶转接器104的液体容器流体连通步骤，液体药物转移装置300与它的输液液体容器活塞布置140在它的打开的流体位置。液体容器流体连通步骤导致液体转移部件103与通用药瓶转接器104相对于注入口转接器102共同旋转直到键146停止在键槽147的相反最末端。在这个位置，开口144与轴向内腔141对齐以建立针头118与轴向内腔123之间的流体连通。插销128在密封的腿末端156处保持在它们的初始位置。液体药物转移装置300保持它的预致动高度H1。
图12A和12B显示液体药物转移装置300与输液液体容器活塞布置140保持在它的打开的流体位置，并且继由箭头F所示在顺时针拧紧方向上围绕旋转轴142相对注入口转接器102继续手动旋转通用药瓶转接器104的药瓶流体连通步骤之后。由于进一步旋转液体转移部件103被键槽147停止，继续手动旋转推动通用药瓶转接器104沿直立的螺旋腿152朝向注入口转接器102。该相对运动导致穿刺尖端119横向通过贯穿顶壁口孔130进入向下垂的裙边131中。当该对向外指向的径向销钉128到达接合点154处时，继续手动旋转停止。开口144保持与轴向内腔141对齐由此建立针头118与穿刺尖端119之间的流体连通。液体药物转移装置300在它的致动后高度H2，其中H2<H1。
图13A和13B显示继由箭头G所示相对注入口转接器102在逆时针松开方向上围绕旋转轴142手动旋转通用药瓶转接器104之后的液体药物转移装置300。手动旋转当销钉128到达腿末端157时停止，并且由锁定部件158锁定。输液液体容器活塞布置140保持在其打开的流体位置，并且开口144与轴向内腔141对齐用于针头118与穿刺尖端119的流体连通。
图14A和14B显示继由箭头H所示相对注入口转接器101在逆时针松开方向上围绕旋转轴142继续手动旋转通用药瓶转接器103之后的液体药物转移装置300在致动状态。由于相对于液体转移部件103进一步旋转通用药瓶转接器104被锁定部件158停止，继续手动旋转推动流体转移部件103与通用药瓶转接器104相对于注入口转接器102共同旋转以使键146返回到键槽147的它的初始第一最末端以关闭输液液体容器活塞布置140。在这个位置，开口144不与轴向内腔141对齐，由此使针头118与液体转移部件103之间不能够流体连通。
图15到22显示液体药物转移装置400，图23到30显示液体药物转移装置500。它和液体药物转移装置100,200和300的相似之处在于前者400和500的每一个都具有纵向的装置轴101，液体容器转接器102，液体转移部件103和药瓶转接器104，因此相似的部分被同样地编号。前者400和500和后者100,200和300的不同之处在于前者400和500具有液体容器转接器102，该液体容器转接器102带有用于直接啮合轴向指向的直立管状药瓶转接器杆137的轴向指向的直立管状液体容器转接器杆171。并且，它们的液体转移部件103被滑动地布置在它们的药瓶转接器杆137中用于在相对于液体容器转接器102手动旋转药瓶转接器104期间被推动用于穿刺药瓶塞子31以与药瓶内部28流体连通。
液体药物转移装置400和500与液体药物转移装置100和200的相似之处在于前者400和500包括沿纵向的装置轴101的第二直线位移，用于执行液体容器流体连通步骤。
液体药物转移装置400和500与液体药物转移装置300的相似之处在于前者400和500执行初始液体容器流体连通步骤和随后药瓶流体连通步骤。
液体药物转移装置400与液体药物转移装置100,200和300的相似之处在于前者400被打算与药瓶20和输液液体容器40一起使用。因此，液体药物转移装置400可被选择地实施使得手动旋转执行初始药瓶流体连通步骤和随后液体容器流体连通步骤，这与液体药物转移装置100和200相似。另外，液体药物转移装置400可被选择地实施带有与输液液体容器活塞布置140相似的输液液体容器活塞布置。
液体药物转移装置500与液体药物转移装置100,200，300和400的不同之处在于前者500被打算使用药瓶50A和液体瓶50B利用如图23所示的液体药物内含物填充初始地空的注射器10用于给患者给药。液体瓶50B通常填充有稀释剂。或者，液体瓶50B可包括活性液体成分。注射器10包括带有活塞杆12和公接头13的管11。公接头13优选地是公鲁尔锁接头。注射器10可与其它类型的公接头，例如滑动式鲁尔接头等，一起形成。
更具体地，图15和19显示液体药物转移装置400包括由注入口转接器构成的液体容器转接器102，该注入口转接器具有通用注入口接头111和液体容器转接器杆171。液体容器转接器杆171包括一对相对的杆部件172，该对相对的杆部件172包括一对向内指向的径向销钉173，其用于沿一对相对的大体上螺旋形轨道174的滑动啮合，该轨道174以与该对轨道138相似的方式在药瓶转接器杆137中形成。轨道174的每一个都具有远离小瓶转接器顶壁129的开始轨道末端176A和邻近小瓶转接器顶壁129的最终轨道末端176B。
液体转移部件103具有前液体转移部件末端103A和后液体转移部件103B中间的中心液体转移部件主体103C。液体转移部件103包括在它的前液体转移部件末端103A处用于针头插入到注入口41的针头118和在它的后液体转移部件末端103B处用于穿刺药瓶塞子31的穿刺尖端119。套筒118A和121相应地保护针头118和穿刺尖端119。
液体转移部件主体103C与一套四个弹性地安装的轴向指向的固定部件(retainingmembers)178一起形成，该固定部件178朝向针头118延伸用于在手动旋转液体药物转移装置400的液体容器流体连通步骤期间卡扣在注入口转接器102上。固定部件178具有固定部件小端178A，该固定部件小端178A带有倾斜的前固定部件小端表面178B的和径向指向的后固定部件小端表面178C。当它们的倾斜的前固定部件小端表面178B，随着针头118被推动通过孔109，沿着限定贯穿注入口凹槽壁孔109的内部注入口凹槽壁边缘108A滑动时，固定部件小端178A在中心液体转移部件主体103C处朝向纵向的装置轴101是向内地径向弯曲的。随着它们的固定部件小端178A穿过贯穿注入口凹槽壁孔109，固定部件178恢复到它们的未弯曲状态，此时，径向指向的后固定部件小端表面178C毗邻注入口凹槽壁108。
同样地液体转移部件主体103C与一套四个弹性地安装的轴向指向的固定部件179一起形成，该固定部件179朝向穿刺尖端119延伸用于在手动旋转液体药物转移装置400的药瓶流体连通步骤期间卡扣在药瓶转接器104上。固定部件179具有固定部件小端179A，该固定部件小端179A带有倾斜的前固定部件小端表面179B和径向指向的后固定部件小端表面179C。当它们的倾斜的前固定部件小端表面179B，随着穿刺尖端119被推动通过孔130，沿着限定贯穿顶壁孔130的内部顶壁边缘129A滑动时，固定部件小端179A在中心液体转移部件主体103C处朝向纵向的装置轴101是向内地径向弯曲的。随着它们的固定部件小端179A穿过贯穿顶壁孔130，固定部件179恢复到它们的未弯曲状态，此时，径向指向的后固定部件小端表面179C卡扣在内部顶壁边缘129A上。
药瓶转接器杆137具有与药瓶转接器裙边131相对的前端面181。药瓶转接器杆137与一对邻近前端面181的向内指向的较小止动元件(stops)182和一对较大止动元件183一起形成，在液体药物转移装置400的预致动状态，该对较大止动元件183向内布置并且与该对较小止动元件182分开一定距离以紧密地接受它们之间的法兰177。该对较小止动元件182和该对较大止动元件183是彼此正交的，用来保证液体转移部件103在转移期间保持在适当位置，并且用来决定药瓶流体连通步骤与液体容器流体连通步骤之间的顺序。
该对较小止动元件182比该对较大止动元件183小使得在相对于注入口转接器102手动旋转药瓶转接器104时，液体转移部件法兰177朝向用于针头118针头插入到注入口41中的注入口转接器102初始地咬在该对较小止动元件182之上以执行液体容器流体连通步骤。当将前液体转移部件末端103A贴近注入口41时，液体转移部件法兰177朝向药瓶转接器104咬在该对较大止动元件183之上用于执行药瓶流体连通步骤。该对较小止动元件182和该对较大止动元件183可颠倒位置使得液体药物转移装置400初始执行药瓶流体连通步骤，随后执行液体容器流体连通步骤。
图20到22显示液体药物转移装置400的使用如下：
图20A和20B显示液体药物转移装置400在预致动状态具有预致动高度H1。该对较小止动元件182和该对较大止动元件183将液体转移部件103保持在药瓶转接器杆137中。该对向内执行的径向插销173部署在开始轨道末端176A处。
图21A和21B显示根据液体容器流体连通步骤，液体药物转移装置400在中间致动状态。液体药物转移装置400具有中间致动高度H3，其中H3<H1。该对向内指向的径向插销173在沿该对相对的轨道174的开始轨道末端176A和最终轨道末端176B中间。固定部件小端178A卡扣在注入口转接器102上，由此固定住在其上的液体转移部件103。
图22A和22B显示接着相对于输液液体转接器102完全手动旋转药瓶转接器104之后，沿纵向的装置轴101完全线性按压之后的液体药物转移装置400在致动后的状态。固定部件小端179A卡扣在内部顶壁边缘129A上由此将液体转移部件103固定到药瓶转接器104上。液体药物转移装置400具有致动后的高度H2，其中H2<H3。完全按压建立注入口41和药瓶20之间的流体连通，由此使液体能够从静脉注射袋流向药瓶20。
更具体地，图23到26显示液体药物转移装置500在结构上与液体药物转移装置400相似，因此相似的部分被同样地编号。前者500在以下三个方面不同于后者400：
首先，液体容器转接器102由与药瓶转接器104相似的液体瓶转接器184构成。液体瓶转接器184包括液体容器转接器杆171。
第二，药瓶转接器杆137配备有一对轴向指向的释放沟(release grooves)186。该轴向指向的释放沟186与螺旋形轨道174滑动连通用于使该对向内指向的径向插销173能够初始下滑螺旋形轨道174然后滑上释放沟186用于在液体药物转移装置500的致动后状态中使液体容器转接器杆171能够从药瓶转接器杆137上拆除。
第三，液体转移部件103具有包括液体瓶构件187和药瓶构件188的两用组件结构。液体瓶构件187包括针头118、与针头118流体连通的轴向指向的公接头189和四个轴向指向的固定部件178。药瓶构件188包括穿刺尖端119、与穿刺尖端119流体连通的轴向指向的母接头191和四个轴向指向的固定部件179。在液体药物转移装置500的预致动状态公接头189被插入母接头191中。公接头189和母接头191优选鲁尔接头。母接头191还打算用于接收注射器的公接头13用于从药瓶50A中注射器抽吸液体药物内含物。
图26到30显示液体药物转移装置500的使用如下：
图26A和26B显示在预致动状态的附接到大药瓶50A和大液体瓶50B上的液体药物转移装置500。该对较小止动元件182和该对较大止动元件183将液体转移部件103固定在药瓶转接器杆137中。该对向内指向的径向插销173部署在开始轨道端176A处。
图27A和27B显示根据液体容器流体连通步骤，液体药物转移装置500在中间致动状态。该液体药物转移装置500具有中间致动高度H3，其中H3<H1。该对向内指向的径向插销173在沿该对相对的轨道174的开始轨道末端176A和最终轨道末端176B的中间。固定部件小端178A卡扣在液体瓶转接器184上由此固定住其上的液体瓶构件187。
图28A和28B显示接着相对于液体瓶转接器184完全手动旋转药瓶转接器104之后，沿纵向的装置轴101完全线性按压之后的液体药物转移装置500在致动后的状态。液体药物转移装置500具有致动后高度H2，其中H2<H3。固定部件小端179A卡扣在药瓶转接器104上由此固定住其上的药瓶构件188。完全按压建立液体瓶50B和药瓶50A之间的流体连通，此时，药瓶50A中的负压从液体瓶50B中吸取其中的液体内含物用于混合和/或重构目的，由此留下空液体瓶50B。
图29A和29B显示如由箭头I所示沿纵向的装置轴101从药瓶转接器104上纵向拆除液体瓶转接器184。将该对向内指向的径向销钉173与该对轴向指向的释放沟186对齐实现纵向的拆除。液体转移部件103分为它的液体瓶构件187和药瓶构件188使得液体瓶转接器184与它的现在空的液体瓶50B和液体瓶构件187一起拆除，药瓶转接器104与它的现在填充有液体药物内含物的药瓶50A和药瓶构件188一起拆除。
图30A和30B显示初始空的注射器10连接到母接头191上，倒置该组合件用于如箭头J所示从药瓶50A中注射器抽吸液体药物内含物以准备填充注射器10，如图23所示。
虽然本发明对有限数目的实施例进行了描述，应该认识到，许多变化、修改及本发明的其它应用都可在权利要求书的范围内做出。

Claims (11)

1.一种液体药物转移装置，其用于双流体连通步骤致动以建立液体容器与药瓶之间的流体连通，所述液体容器含有液体内含物，所述药瓶具有药瓶瓶体，含有药剂的药瓶内部，药瓶塞子，最上药瓶表面以及药瓶封闭物，
所述液体药物转移装置具有纵向的装置轴，并且包括：
(a)液体容器转接器，其用于连接到液体容器上；
(b)双末端液体转移部件，其具有前液体转移部件末端和后液体转移部件末端，所述前液体转移部件末端与所述液体容器流体连通，所述后液体转移部件末端与所述前液体转移部件末端流体连通并且终止在用于刺穿药瓶塞子以与药瓶内部流体连通的刺穿尖端；以及
(c)药瓶转接器，其具有横向的小瓶转接器顶壁、向下垂的小瓶转接器裙边和轴向指向的直立管状药瓶转接器杆，所述小瓶转接器顶壁带有限定沿纵向的装置轴的贯穿顶壁孔的内部顶壁边缘，所述小瓶转接器裙边用于伸缩地夹在药瓶封闭物上使得所述贯穿顶壁孔位于最上药瓶表面之上，所述药瓶转接器杆围绕所述贯穿顶壁孔，与所述向下垂的小瓶转接器裙边相对，并且啮合所述双末端液体转移部件，
布置为使得在预致动状态的液体药物转移装置具有预致动高度H1，所述液体转移部件布置在所述药瓶转接器杆中使得所述刺穿尖端位于所述最上药瓶表面之上，从而相对于所述液体容器转接器围绕所述纵向的装置轴的所述药瓶转接器的手动旋转沿所述装置轴按压液体药物转移装置到致动后的高度H2，其中H2<H1，并且执行下面两个流体连通步骤：
i)药瓶流体连通步骤，其用于沿线性位移推动所述穿刺尖端以穿刺通过药瓶塞子用于与药瓶内部流体连通，以及
ii)液体容器流体连通步骤，其用于建立所述前液体转移部件末端与所述液体容器之间的流体连通。
2.根据权利要求1所述的装置，其中所述液体容器是具有进入口的输液液体容器，所述液体容器转接器由用于连接到进入口上的进入口转接器构成，
所述前液体转移部件末端啮合所述进入口转接器，所述后液体转移部件末端啮合所述药瓶转接器，以及
所述前液体转移部件末端包括进入口流体部件，所述进入口流体部件用于在执行双流体连通步骤致动的所述手动旋转期间插入到进入口中。
3.根据权利要求1所述的装置，其中所述液体容器是具有进入口的输液液体容器，所述液体容器转接器由用于连接到进入口的进入口转接器构成，
所述前液体转移部件末端啮合所述进入口转接器，所述后液体转移部件末端啮合所述药瓶转接器，
所述进入口转接器包括进入口流体部件，该进入口流体部件用于当将进入口转接器连接到输液液体容器上时插入到进入口中，以及
所述前液体转移部件末端包括输液液体容器活塞布置，该输液液体容器活塞布置用于选择性地关闭和打开与所述进入口流体部件的流体连通。
4.根据权利要求1所述的装置，其中所述液体容器转接器包括用于啮合所述药瓶转接器杆的轴向指向的直立管状液体容器转接器杆，所述液体转移部件滑动地布置在所述药瓶转接器杆中。
5.根据权利要求4所述的装置，其中所述液体容器是具有进入口的输液液体容器，所述液体容器转接器由用于连接到进入口上的进入口转接器构成，
所述前液体转移部件末端包括用于在相对于所述液体容器转接器手动旋转所述药瓶转接器期间滑动插入到进入口中的进入口流体部件。
6.根据权利要求4所述的装置，其中所述液体容器是具有进入口的输液液体容器，所述液体容器转接器由用于连接到进入口上的进入口转接器构成，
所述进入口转接器包括进入口流体部件，所述进入口流体部件用于当将进入口转接器连接到输液液体容器上时插入到进入口中，以及
所述前液体转移部件末端包括输液液体容器活塞布置，所述输液液体容器活塞布置用于选择性地关闭和打开与所述进入口流体部件的流体连通。
7.根据权利要求4所述的装置，其中所述液体容器由含有液体内含物的液体瓶构成，所述液体瓶具有液体瓶瓶体，含有液体内含物的液体瓶内部，液体瓶塞子，最上液体瓶表面和液体瓶封闭物，
所述液体容器转接器由液体瓶转接器构成，所述液体瓶转接器具有横向的小瓶转接器顶壁、向下垂的小瓶转接器裙边和所述轴向指向的直立管状液体容器杆，所述小瓶转接器顶壁带有限定贯穿顶壁孔的内部顶壁边缘，所述小瓶转接器裙边用于伸缩地夹在液体瓶封闭物上使得所述贯穿顶壁孔位于所述最上液体瓶表面之上，所述液体容器杆围绕所述贯穿顶壁孔并且与所述向下垂的小瓶转接器裙边相对，
所述液体瓶转接器从所述药瓶转接器是可拆除的用来为注射器从药瓶中抽吸液体内含物提供通道。
8.根据权利要求7所述的装置，其中所述液体转移部件具有双构件结构，所述双构件结构包括药瓶构件和与在所述预致动状态的所述药瓶构件可拆除初始地密封连接的所述液体瓶构件，当将所述液体瓶转接器从所述药瓶转接器上拆除时，所述药瓶构件保持连接到所述药瓶转接器上，所述液体瓶构件保持连接到所述液体瓶转接器上，所述药瓶构件具有暴露的接头用于提供所述注射器从药瓶中抽吸液体药物内含物。
9.根据权利要求7所述的装置，其中所述药瓶处于负压下，所述手动旋转执行初始液体容器流体连通步骤和随后药瓶流体连通步骤，从而能够使所述负压从液体瓶中抽吸液体内含物到药瓶中。
10.根据权利要求1到9任一项所述装置，其用于提供用户指示用于指示液体容器与药瓶之间的流体连通的建立。
11.根据权利要求1到10任一项所述的装置，其包括预连接的初始未开启的药瓶。
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