CN105120826B - 用于安装到顶部开口的药物容器以形成药物重构组件用于与无针注射器一起使用的药物容器密封件 - Google Patents

用于安装到顶部开口的药物容器以形成药物重构组件用于与无针注射器一起使用的药物容器密封件 Download PDF

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CN105120826B
CN105120826B CN201480021147.7A CN201480021147A CN105120826B CN 105120826 B CN105120826 B CN 105120826B CN 201480021147 A CN201480021147 A CN 201480021147A CN 105120826 B CN105120826 B CN 105120826B
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尼姆罗德·列弗
莫迪凯·布赫曼
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Abstract

药物容器密封，所述药物容器密封用于安装到顶部开口的药物容器上以形成准备使用的药物重构组件用于与无针注射器一起使用。该药物容器密封包括用于密封药物容器的药物容器瓶塞和具有一体的无针注射器连接头和穿刺套管的流体转移部件。该流体转移部件沿着正好相反的颠倒的L形轨道对从初始的非穿刺位置到穿刺位置被手动地设置。该颠倒的L形轨道对包括单路卡扣部件以阻止使用者将流体转移部件返回到早先的位置，指示用户发动的进程。

Description

用于安装到顶部开口的药物容器以形成药物重构组件用于与无针注射器一起使用的 药物容器密封件
技术领域
本发明涉及用于安装到顶部开口的药物容器以形成所谓的准备使用(ready-to-use)的药物重构组件用于与无针注射器一起使用的药物容器密封件。该药物容器密封件包括用于密封顶部开口的药物容器的药物容器瓶塞和流体转移部件，该流体转移部件具有一体的无针注射器连接头和穿刺套管。
背景技术
包括顶部开口的药物容器和药物容器密封件的准备使用的药物重构组件在现有技术中是已知的，该药物容器密封件具有带有一体的无针注射器连接头和穿刺套管的流体转移部件。典型的现有技术尤其包括：
美国专利号4,576,211(Valentini等)，发明名称：用于连接注射器和含有药物的瓶或用于注射器输送的药物的小管的嘴或开口的安全设备
美国专利号5,429,614(Fowles等)，发明名称：药物输送系统
美国专利号5,776,116(Lopez等)，发明名称：医疗连接头
美国专利号5,902,280(Powles等)，发明名称：包含真空的吸入式针头仪器(Aspiration needle apparatus)和方法以及与其一起使用的转接器
美国专利号6,070,623(Aneas等)，发明名称：尤其在具有能够打孔的瓶塞的接收器(receptacle)和注射器之间的连接设备
美国专利号6,382,442(Thibault等)，发明名称：用于小瓶和其它医疗容器的塑料密封
美国专利号6,478,788(Aneas)，发明名称：用于在接受体(recipient)和容器(container)之间连接的设备和包括此类设备的准备使用的组件
美国专利号6,706,031(Manera)，发明名称：无针进入仪器和系统
美国专利号7,074,216(Fowles等)，发明名称：用于稀释剂容器的滑动重构设备
美国专利号7,195,623(Burroughs等)，发明名称：包括用于在注射笔套筒中配制药物的侧面注射的注射器针头的试剂盒
美国专利号7,615,041(Sullivan等)，发明名称：小瓶转接器
美国专利号8,225,949(Aneas)，发明名称：用于容器的塞子设备和配备有一个此类设备的容器
美国专利号8,480,646(Nord等)，发明名称：医疗设备连接头
美国专利号8,562,582(Tuckwell等)，发明名称：重构设备
美国专利申请公开号2012/0310203，发明名称：仪器和方法
美国专利申请公开号2013/0053814，发明名称：设备
需要包括顶部开口的药物容器和在其上安装的药物容器密封件的改进的准备使用的药物重构组件。
发明内容
本发明针对的是药物容器密封件，其用于安装到顶部开口的药物容器上以形成所谓的准备使用的药物重构组件用于与无针注射器一起使用。
该药物容器密封件包括以下三个主要的组件：用于稳固地安装在顶部开口的药物容器上的密封外壳，稳固地安装在密封外壳上用于密封药物容器的药物容器瓶塞，和滑动地安装在密封外壳上的流体转移部件。该流体转移部件包括与穿刺套管一体成形的无针注射器连接头，该穿刺套管用于穿刺药物容器瓶塞且与无针注射器连接头流体连通。
该密封外壳优选地包括正好相反的颠倒的L形轨道对，用于导向流体转移部件从最初的非穿刺位置到最终的穿刺位置的向下移动。或者，密封外壳可被设计具有单个颠倒的L形轨道或3个或更多个颠倒的L形轨道。
该颠倒的L形轨道被配置以要求使用者为了使流体转移部件从其最初的非穿刺位置导向到其最终的穿刺位置执行以下两个操作：初始小幅度顺时针旋转(Aninitial minor clockwise rotation)，用于启动药物重构组件用来发动，和随后的大幅度发动位移(a subsequent major activation displacement)，用于穿刺药物容器瓶塞。颠倒的L形轨道保证了排除不经意的预穿刺的安全通路并且包括单路卡扣部件以防止使用者将流体转移部件返回到早先的位置，从而提供了改动迹象(tamperevidence)。该单路卡扣部件还提供了听得见的用户指示用于指示继续下一个用户操作。
该药物容器密封件可具有带有打开或关闭的颠倒的L形轨道的密封外壳。前者要求额外的护套用于封闭地密封向下悬挂的穿刺套管。后者要求外部的安装在密封外壳上的额外的套筒用来密封开口的轨道，从而排除了额外的护套的需要。
该流体转移部件可以通气形式或非通气形式被设置。无针注射器连接头可作为母鲁尔锁接头形成。无针注射器连接头可作为可洗(swabbable)自密封端口形成用于多重吸入液体药物内含物。
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，附图中相同的部分被同样地编号，并且其中：
图1根据本发明的药物重构组件在初始的非穿刺位置与无针注射器一起使用的第一实施例的图形表明；
图2是图1的药物重构组件的分解正视图；
图3是图1的药物重构组件的顶视图；
图4是图1的药物重构组件沿图3中A-A线的纵向截面图；
图5是图1的药物重构组件沿图3中B-B线的纵向截面图；
图6是图1的药物重构组件的分解正视图；
图7是图1的药物重构组件沿图6中C-C线的纵向截面图；
图8是具有一体的无针注射器连接头和穿刺套管的图6的流体转移部件的正视图；
图9是图8的流体转移部件沿其上的D-D线的纵向截面图；
图10是图1的药物容器密封件的密封外壳和药物容器瓶塞的纵向截面图；
图11是图1的药物容器密封件在初始的非穿刺位置的纵向截面图；
图12是图1的药物容器密封件被推到待发位置准备发动的纵向截面图；
图13是图1的药物容器密封件在最终的穿刺位置的纵向截面图；
图14A到14C显示图1的药物重构组件的使用；
图15是根据本发明的药物重构组件在初始的非穿刺位置的第二实施例的正视图；以及
图16是图15的药物重构组件沿其上的E-E线的纵向截面图。
本发明优选实施例的详细描述
图1显示了与构成生理液体源的无针注射器10一起使用的准备使用的药物重构组件100。药物重构组件100包括由顶部开口的药瓶构成的顶部开口的药物容器20和在其上稳固地安装的药物容器密封件30。顶部开口的药物容器20或者由用于存储粉末或液体药物的其它医疗容器和接受器构成。
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可与其它类型的公连接头一起形成。注射器10填充有液体组分14。该液体组分可仅仅是稀释剂。或者，该液体组分14可包括活性组分。
图2显示顶部开口的药瓶20具有纵轴21并且包括药瓶肩22、药瓶边缘23和中间窄的药瓶颈24。药瓶边缘23限定药瓶开口26。药瓶20含有粉末或液体药物27。
图2到图13显示药物容器密封件30包括纵向中心线31和密封外壳32，密封外壳32用于稳固地卡扣配合安装到药瓶20和用于密封药瓶开口26的药物容器瓶塞33上。密封外壳32容纳流体转移部件34，流体转移部件34从初始的非穿刺位置滑动位移到最终的穿刺位置用来穿刺药物容器瓶塞33。流体转移部件34包括一体的无针注射器连接头36和与注射器连接头36流体连通的穿刺套管37。无针注射器连接头36作为可洗母鲁尔锁接头形成用来在其上螺纹安装母连接头13。药物容器密封件30包括用于密封无针注射器连接头36的密封帽38。
密封外壳32由合适的塑料材料制成并且包括正好相反的颠倒的L形轨道对(track pair)39，该L形轨道对39用于导向流体转移部件34从其初始的非穿刺位置到其最终的穿刺位置的发动位移。药物容器密封件30包括在密封外壳32外部的套管41，密封外壳32用来密封正好相反的颠倒的L形轨道对(track pair)39以保证穿刺套管37的无菌。套管41包括卡扣配合部件42，卡扣配合部件42用来在组装准备使用的药物重构组件100期间向下按压药物容器密封件30到药瓶20上时卡扣配合到药瓶边缘23上。
流体转移部件34包括与无针注射器连接头36一起形成的环形基底部件43和穿刺套管37。基底部件43包括径向的向外定向的销钉对44，销钉对44用来沿着正好相反的颠倒的L形轨道对39行进用于流体转移部件34的导向发动位移。流体转移部件34可选择地包括通气式装置(venting arrangement)46，如共同拥有的WIPO国际公开号WO 2011/104712(发明名称：具有通气式小瓶转接器的液体药物转移装置)中所公开的。
密封外壳32包括横向构件47，横向构件47具有横向构件上侧47A和横向构件下侧47B并且与中心孔48一起形成，中心孔48用于穿刺套管37从中穿过。横向外壳下侧47B与药物容器瓶塞33一体成形。横向部件47与药物容器瓶塞33可被叠加注塑在一起。或者，横向部件47可被机械地连接、锻造、粘附等到药物容器瓶塞33上。
颠倒的L形轨道39各自包括与纵向的中心线31同向的末端开口的直立的进入腿49、横向于纵向的中心线31的水平的启动腿(priming leg)51和与纵向的中心线31平行的直立的发动腿(activation leg)52。主直立的发动腿52具有相应地邻近和远离启动腿51的近端的发动腿末端52A和远端的发动腿末端54B。
颠倒的L形轨道39还各自包括以下的三个单路卡扣部件(one-way snapmember)：
在开口的直立的进入腿49和水平的启动腿51之间的结合点54处的单路保持卡扣部件53。单路保持卡扣部件53使流体转移部件34在使用之前保持在密封外壳32中。
在水平的启动腿51和近端的发动腿末端52A之间的结合点57处的单路待发的卡扣部件(one-way primed snap member)56。
在远端的发动腿末端52B处的单路经发动的卡扣部件(one-way activated snapmember)58。
图11显示使用之前在其初始安装位置的流体转移部件34。向外定向的销钉对44沿着水平的启动腿对(horizontal priming leg pair)51定位，越过单路保持卡扣部件对53且在单路待发的卡扣部件对56前面。穿刺套管36被配置在中心孔48以上的位置以穿刺药物容器瓶塞33。
图12显示流体转移部件34被推动越过单路待发的卡扣部件对(one-wayprimed snap member pair)56到达在近端的发动腿末端对52A处的它的待发位置准备用于发动。达到这种位置是通过使用者螺纹安装无针注射器10到药物重构组件100上并且继续在顺时针拧紧方向上旋转无针注射器10直到向外定向的销钉对44卡扣越过单路待发的卡扣部件对56。随着向外定向的销钉对44卡扣越过单路待发的卡扣部件对56，使用者听到咔嚓声，表明他能继续发动。穿刺套管36保持被配置在中心孔48以上的位置以穿刺药物容器瓶塞33。单路待发的卡扣部件对56阻止流体转移部件34返回到水平的启动腿对51。
图13显示了流体转移部件34在远端的发动腿末端对52B处的它的经发动的位置。达到这种位置是通过使用者朝向药瓶20按压无针注射器10直到向外定向的销钉对44卡扣越过单路经发动的卡扣部件对(one-way activated snap memberpair)58。随着向外定向的销钉对44卡扣越过单路经发动的卡扣部件对58，使用者听到咔嚓声，表明他能继续药物重构和投予。单路经发动的卡扣部件对58阻止流体转移部件34返回到早先的位置。
现在参考附图14A到14C，药物重构组件100的使用被描述如下：
图14A显示了在使用之前在其安装位置的药物重构组件100，如图11所示。使用者从药物重构组件100移走密封帽38以暴露无针注射器连接头36。
图14B显示使用者如箭头A所示在顺时针方向螺纹安装无针注射器10到无针注射器连接头36上以在其上初始地密封注射器10并且随后推动流体转移部件34以停止在近端的发动腿末端对52A处，如图12所示。随着流体转移部件34越过单路待发的卡扣部件对56，使用者听到咔嚓声，表明药物重构组件100准备用于发动。
图14C显示使用者如箭头B所示沿着发动腿52向下推动流体转移部件34以停止在远端的发动腿对末端52B处，如图13所示。该位移引起穿刺套管37穿刺通过药物容器瓶塞33。随着流体转移部件34越过单路经发动的卡扣部件对58，使用者听到咔嚓声以表明他能继续药物重构和投予。
图15到图16显示准备使用的药物重构组件200，其在结构和操作上类似于准备使用的药物重构组件100，因此，相同的部件被同样地编号。后者200不同于前者100之处在于后者200没有套筒41，因此，其密封外壳32与卡扣配合部件42一起形成并且具有相反开口的颠倒的L形轨道对39。后者200包括放置在穿刺套管37上的护套61用于保证无菌。当向下移动流体转移部件34到其最终的穿刺位置时，护套61破裂且被推动向上靠着横向部件下侧48B。
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 (4)

1.药物容器密封件，所述药物容器密封件用于安装到顶部开口的药物容器以形成准备使用的药物重构组件，用于与无针注射器一起使用，所述顶部开口的药物容器具有限定药物容器开口的药物容器边缘，所述药物容器密封件具有纵向的中心线并且包括：
(a)管状的密封外壳，所述管状的密封外壳用于稳固地安装在药物容器边缘上，所述密封外壳包括至少一个颠倒的L形轨道，所述颠倒的L形轨道具有末端开口的直立的进入腿、水平的启动腿和直立的发动腿，所述发动腿具有相应地接近和远离所述启动腿的近端的发动腿末端和远端的发动腿末端，每个所述颠倒的L形轨道具有：
i)在所述末端开口的直立的进入腿和所述水平的启动腿之间的单路保持卡扣部件，
ii)在所述水平的启动腿和所述近端的发动腿末端之间的单路待发的卡扣部件，以及
iii)朝向所述远端的发动腿末端的单路经发动的卡扣部件；
(b)药物容器瓶塞，所述药物容器瓶塞稳固地安装在所述密封外壳上用于当稳固地安装所述密封外壳到药物容器边缘上时密封所述药物容器开口；以及
(c)流体转移部件，所述流体转移部件具有一体的无针注射器连接头和与其流体连通的穿刺套管，所述无针注射器连接头用于在其上连接无针注射器，所述穿刺套管用于穿刺所述药物容器瓶塞，
当相对于所述纵向的中心线手动旋转所述流体转移部件时，所述流体转移部件届时沿着每个所述水平的启动腿初始地被设置，所述流体转移部件在被手动地推动越过每个所述单路经发动的卡扣部件到达每个所述远端的发动腿末端用于穿刺所述药物容器瓶塞用于与药物容器流体连通之前，它被推动越过每个所述单路待发的卡扣部件到达每个所述的近端的发动腿末端。
2.根据权利要求1所述的密封件，所述密封件进一步包括在所述密封外壳外部的套筒，该套筒用于密封每个所述颠倒的L形轨道以保证所述穿刺套管的无菌。
3.根据权利要求1所述的密封件，所述密封件进一步包括在所述穿刺套管上的护套。
4.准备使用的药物重构组件，所述药物重构组件包括顶部开口的药物容器和在其上安装的根据权利要求1-3任一项所述的药物容器密封件。
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US9801786B2 (en) 2017-10-31
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