CN102711712A - 具有通风布置的流体转移组合件 - Google Patents
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Abstract
一种流体转移组合件,其包含通风的母小瓶适配器以及公小瓶适配器,所述小瓶适配器与一对小瓶一起使用以进行液态药品的重组和给药,其中所述一对小瓶中的一个小瓶在负压下具有内含物。所述通风的母小瓶适配器包含通风布置,而所述公小瓶适配器包含用于选择性地密封所述通风布置的密封布置。所述流体转移组合件如此设计以致在重组液态药品内含物后在负压下仅吸入过滤过的空气至所述小瓶中,从而确保无菌条件。
Description
技术领域
本发明涉及用于液态药品重组和给药的流体转移组合件。
背景技术
意格(Zinger)等人共同拥有的第6,558,365号美国专利说明及描述了一种流体转移组合件,所述组合件包括用来与用于液态药品重组和给药的一对小瓶一同使用的一对起初相互啮合的小瓶适配器。此种流体转移(输送)组合件是以注册商标商购自本审请人在以色列让纳纳(Ra’anana,Israel)的麦迪麦珀医疗工程有限公司(Medimop Medical Projects Ltd.)。所述一对小瓶适配器中的一个小瓶适配器包含母连接器,在下文中称为“母小瓶适配器(female vial adapter)”,而另一个小瓶适配器包含公连接器,在下文中称为“公小瓶适配器(male vial adapter)”。所述公和母连接器是鲁尔(Luer)连接器,并且优选为鲁尔锁合连接器(Luer lock connectors)。通常情况下,所述小瓶中的一个小瓶容纳稀释剂,而另一个小瓶在真空下容纳粉末状药品药剂。典型的小瓶大小包含13mm的颈直径和20mm的颈直径。
从流体转移组合件的起初装配好的配置开始的液态药品重组和给药包含以下步骤:
(a)将稀释剂容纳小瓶固持在平坦表面上并且将公小瓶适配器向下搭扣配合到所述小瓶上;
(b)翻转流体转移组合件来保持流体转移组合件直立,并且公小瓶适配器及其连接的稀释剂容纳小瓶在母小瓶适配器之上;
(c)将药剂容纳小瓶固持在平坦表面上并且将母小瓶适配器向下搭扣配合到所述小瓶上,于是在药剂容纳小瓶中盛行的真空将稀释剂从稀释剂容纳小瓶快速地吸到其中,从而在流体转移组合件以及两个连接的小瓶的密封组合体中形成重组的液态药品并且将剩余真空遗留在其中;
(d)轻轻地晃动流体转移组合件以及两个连接的小瓶的密封组合体,从而在连接到母小瓶适配器的小瓶中完全重组液态药品药剂;
(e)通过从母鲁尔连接器拧松公鲁尔锁合连接器,将公小瓶适配器与母小瓶适配器分离;
(f)将具有公鲁尔锁合连接器的注射器旋紧至母小瓶适配器上;
(g)翻转母小瓶适配器及其连接的小瓶,从而将重组的液态药品吸至注射器中;以及
(h)从母小瓶适配器拧松注射器,附接一根针并且将重组的液态药品给药。
步骤(a)至(d)是在无菌条件下执行,但步骤(e)通过母小瓶适配器的母连接器吸入周围的空气至连接到母小瓶适配器的小瓶中,从而均衡其中的负压。周围空气,尤其是在门诊诊所、医院以及同类地方,可能是腐败性的,因此污染重组的液态药品内含物。此外,在某些情况下,母小瓶适配器是在开始使用之前准备好并且为随后的使用保持直立状态,因此使得重组的液态药品内含物暴露在周围空气中。
发明内容
本发明针对在构造和操作上类似于迄今描述的流体转移组合件的流体转移组合件,并且所述流体转移组合件另外能阻止在将公小瓶适配器与母小瓶适配器分离时将可能为腐败性的空气不良地吸入到连接至母小瓶适配器的小瓶中,从而维持重组液态药品的无菌状态。这通过以下两个方面来实现:用通风(通气)的母小瓶适配器替代迄今使用的不通风的母小瓶适配器,所述通风的母小瓶适配器包含具有一个空气过滤器以及一个或多个通风口(通气口)的通风布置;以及提供具有密封布置的别样的传统公小瓶适配器,所述密封布置具有用于密封所述通风口的一个或多个口密封构件。
本发明如此设计以致于将公小瓶适配器与母小瓶适配器分离的前述步骤e)有效地划分成用户辨别不出的两步骤过程,如下所述:第一,初始轴向位移致使密封布置打开母小瓶适配器的通风口,从而通过其空气过滤器吸入周围空气至其连接的容纳重组的液态药品的小瓶中,以便在公连接器不密封母连接器之前用周围压力均衡其剩余的真空。空气过滤器阻止腐败性空气被吸入到重组的液态药品容纳小瓶中,从而维持其内含物的无菌性。第二,继续轴向位移会完成公小瓶适配器与母小瓶适配器的机械分离。
本发明的流体转移组合件优选用泡壳包装,并且其公小瓶适配器预先装配在其母小瓶适配器上,从而促进其在重组和给药方面的使用。或者,公小瓶适配器和母小瓶适配器可作为离散(分离)组件来供应,这样就要求用户在进行重组和给药之前将公小瓶适配器装配在母小瓶适配器之上。流体转移组合件可预先装配成重组就绪状态,即,其公连接器密封其母连接器并且其密封布置密封其通风布置。或者,流体转移组合件可预先装配成重组未就绪状态,其中其密封布置从其通风口发生轴向位移,因此不密封其通风布置。此种流体转移组合件要求其公小瓶适配器向其母小瓶适配器发生轴向位移,从而推动其公连接器密封其母连接器以及其密封布置密封其通风布置,从而使流体转移组合件从其重组未就绪状态转变到其重组就绪状态。此轴向位移优选地在流体转移组合件的小瓶上进行搭扣配合期间自动发生以进行重组。由于密封布置仅密封通风布置(如进行重组所要求的)且从而阻止其间无意的粘着,可设想后面的重组未就绪状态比前面的重组就绪状态提供更长的闲置寿命(Shelf life)。
本发明可很容易地实施成用于许多不同的小瓶,所述小瓶包含颈直径为13mm的小瓶,颈直径为20mm的小瓶以及所谓的大直径小瓶--颈直径通常为28mm、32mm以及更大。所述一或多个口密封构件优选设计成在通风的母小瓶适配器上另外稳定公小瓶适配器,并且密封所述通风的母小瓶适配器的一或多个通风口。既定用于大直径的大小瓶的流体转移组合件优选包含通风的母小瓶适配器,其具有适于接收IV道钉的母连接器。流体转移组合件可包含替代的与旋紧布置相互啮合的布置,其中包含摩擦配合布置以及同类物。
母小瓶适配器可任选地具备盖子,所述盖子用于密封其母连接器,从而在公小瓶适配器与母小瓶适配器机械分离后为所述母连接器重组的液态药品内含物维持无菌环境。所述盖子可呈手动放置的顶盖、预先分离的隔膜以及同类物的形式。
附图说明
为了理解本发明并且明白它如何能在实际中实施,现在将仅通过非限制性实例,参看附图,描述优选实施例,在附图中相似的部分同样地编号,并且其中:
图1是根据本发明的第一实施例的在初始重组就绪状态下的流体转移组合件、注射器以及成对的小瓶的图示,所述流体转移组合件包含通风的母小瓶适配器以及公小瓶适配器;
图2是图1的通风的母小瓶适配器沿着图1中的线A-A的俯视透视剖视图;
图3是图1的通风的母小瓶适配器的仰视透视剖视图;
图4是图1的公小瓶适配器的纵向横截面;
图5是图1的通风的母小瓶适配器的仰视透视剖视图;
图6是图1的流体转移组合件以及用于液态药品内含物重组的两个连接的小瓶的前视透视图;
图7是图6的组合体沿着图6中的线B-B的纵向横截面;
图8是公小瓶适配器起初从通风的母小瓶适配器发生轴向位移之后,图6的组合体沿着图6中的线B-B的纵向横截面;
图9是公小瓶适配器与通风的母小瓶适配器完全机械分离之后,图6的组合体的前视透视图;
图10是根据本发明的第二实施例的在初始重组就绪状态下的流体转移组合件的图示;
图11是图10的通风的母小瓶适配器和公小瓶适配器的图示;
图12是根据本发明的第三实施例的在初始重组就绪状态下的流体转移组合件的图示;
图13是图12的通风的母小瓶适配器和公小瓶适配器的图示;
图14是根据本发明的第四实施例的使用大直径小瓶以及IV道钉的流体转移组合件的图示;
图15是图14的通风的母小瓶连接器沿着图14中的线C-C的纵向横截面;
图16是图14的通风的母小瓶连接器的纵向横截面,其中所述母小瓶连接器具有用于液态药品给药的IV道钉;
图17是图1的通风的母小瓶适配器的图示,所述母小瓶适配器包含用于密封其母连接器的手动放置的顶盖;
图18是图1的通风的母小瓶适配器沿着图1中的线A-A的俯视透视剖视图,所述母小瓶适配器包含用于密封其母连接器的预先分离的隔膜;
图19是在初始重组未就绪状态下的流体转移组合件的图示,所述流体转移组合件包含通风的母小瓶适配器和公小瓶适配器;
图20是图19的公小瓶适配器的图示;以及
图21是在重组就绪状态下的图19的流体转移组合件的图示。
具体实施方式
图1图示在初始重组就绪状态下的流体转移组合件100,其与空注射器10以及构成药用容器的一对小瓶20A和20B一起使用。流体转移组合件100具有纵轴101并且包含通风的母小瓶适配器110,所述母小瓶适配器具有通风布置110A并且起初是旋紧至公小瓶适配器130上,所述公小瓶适配器具有用于选择性密封通风布置110A的密封布置130A。注射器10包含具有柱塞12以及公鲁尔锁合连接器13的圆筒11。注射器10可由其他类型的公连接器形成。小瓶20包含顶端打开的瓶21,其由小瓶塞22密封,所述小瓶塞由金属条带23包覆顶端。小瓶20A具有小瓶内部24,其在负压下容纳粉末或液态药剂26。小瓶20B具有小瓶内部24,其容纳液态药剂27,用于重组小瓶内含物26以形成重组的液态药品内含物28。液态药剂27可以是稀释剂或包含活性药品成分。
图2和图3图示通风的母小瓶适配器110,其包含:横向顶壁111;向下依赖(悬垂)的套筒(裙缘)112,其具有用于搭扣配合至小瓶20A的挠曲构件113;以及向下依赖的尖锐插管114,其具有用于刺穿小瓶20A的小瓶塞22的液体转移管腔116;以及与液体转移管腔116流体连通的相反定向的母连接器117。母连接器117优选为在自由端处包含外螺纹117A的母鲁尔连接器。
通风布置110A包含安置在顶壁111之下的环形空气过滤器118,在顶壁111中形成的四个等距间隔的圆形通风口119以及在尖锐插管114中形成的通风管腔121,用于在将母小瓶适配器110搭扣配合至小瓶20A时在通风口119和小瓶20A的小瓶内部之间建立流体连通。通风口119与顶壁111齐平,并且每个通风口包含通风孔122以及环形弹性体轮缘123,所述轮缘安置在顶壁111上用于在对其施加轴向力时密封通风口119。图4和图5图示公小瓶适配器130,其包含;横向顶壁131;向下依赖的套筒132,其具有用于搭扣配合至小瓶20B的挠曲构件133;向下依赖的尖锐插管134,其具有用于刺穿小瓶20B的小瓶塞22的液体转移管腔136;以及与液体转移管腔136流体连通的相反定向的公连接器137。公连接器137优选为用于与母鲁尔连接器117旋紧啮合的公鲁尔锁合连接器。
密封布置130A包含一对相对的轴向定向的口密封构件138,其用于支撑环形口密封构件139,所述口密封构件在流体转移组合件100的初始重组就绪状态下,对弹性体轮缘123施加轴向力来密封通风口119。密封布置130A也在流体转移组合件100的初始重组就绪状态下,在通风的母小瓶适配器110上稳定公小瓶适配器130。
图6至图9图示流体转移组合件100在重组和给药方面的使用。
图6和图7图示流体转移组合件100搭扣配合至两个小瓶20A和20B的组合体140,所述组合体按照上述步骤(a)至(d)在小瓶20A中形成重组的液态药品内含物28。组合体140包含与公连接器137密封啮合的母连接器117以及密封布置130A,所述密封布置在将流体转移组合件100搭扣配合至小瓶20A和20B之前密封通风口119。相对的顶壁111和131之间的轴向间隔由高H1表示。箭头P表示为形成重组的液态药品内含物28而将液态药剂27从小瓶20B吸入到小瓶20A中。
图8图示通过从母鲁尔连接器117初始拧松公鲁尔锁合连接器137(由箭头Q表示),公小瓶适配器130从通风的母小瓶适配器110发生的初始轴向位移。初始轴向位移由轴向间隔H2表示,其中H2稍高于H1且设计成使得密封布置130A能够在公鲁尔锁合连接器137不密封母鲁尔连接器117之前打开通风口119。初始轴向位移通常大约是公鲁尔锁合连接器137和母锁合连接器117之间的鲁尔锁合相互啮合的齿距。正如箭头R表示的,通风布置110A的开口通过空气过滤器118吸引过滤过的空气至小瓶20A中,以便用周围的压力均衡小瓶的剩余负压。
图9图示通过继续从母鲁尔连接器117拧松公鲁尔锁合连接器137使公小瓶适配器130从通风的母小瓶适配器110继续发生轴向位移,直到完全机械分离,从而露出母鲁尔连接器117来附接注射器10,以便将重组的液态药品内含物27给药。
图10和图11图示流体转移组合件150,其在构造和操作上类似于流体转移组合件100,因此,相似的部分同样编号。流体转移组合件150包含通风的母小瓶适配器110,其具有相对于通风布置110A改进的通风布置151。通风布置151包含顶端打开的通风口119,其相对于顶壁111凸起,并且每个口具有向纵轴101倾斜的通风孔122。通风口119具备环形弹性体轮缘123,其用于在流体转移组合件150的初始重组就绪状态下被环形口密封构件139压低而密封通风口119。
图12和图13图示流体转移组合件160,其在构造和操作上类似于流体转移组合件100,因此,相似的部分同样编号。流体转移组合件160包含通风的母小瓶适配器110,其具有相对于通风布置110A改进的通风布置161。通风布置161包含四分之一球体形状的通风口119,其相对于顶壁111凸起并且每个口具有通风孔122,所述通风孔相对于纵轴101辐射状面向外部并且配有半圆形弹性体轮缘123。公小瓶适配器130具有三个细长的口密封构件139,其用于在流体转移组合件160的初始重组就绪状态下密封通风口119。
图14图示用于一对大直径小瓶(例如,颈直径为32mm)以及IV装置30(包含IV道钉(IV spike)31、腔室32以及IV管33)的流体转移组合件170。流体转移组合件170具有与流体转移组合件100相似的构造,因此,相似的部分同样编号。流体转移组合件170包含具有通风布置110A的通风的母小瓶适配器171以及具有密封布置130A的公小瓶适配器172。流体转移组合件170具有初始重组就绪状态,其中公小瓶适配器172旋紧啮合至母小瓶适配器171上。
就母连接器117改变以接纳IV道钉31来说,通风的母小瓶适配器171不同于通风的母小瓶适配器110。母小瓶适配器171包含母连接器117,所述母连接器相对于其顶壁111的高度比母小瓶适配器110的母连接器117高,以便密封地容纳IV道钉31。公小瓶适配器172包含口密封构件139,所述密封构件相对于其顶壁131的高度比公小瓶适配器130的口密封构件139高,以便补偿母小瓶适配器171的母连接器117。图15和图16图示母连接器117,其包含环形密封件173,用于在流体转移组合件170的初始重组就绪状态下密封公连接器137并且在液态药品给药期间密封IV道钉31。
图17图示图1的通风的母小瓶适配器110,其包含手动放置的顶盖124来在液态药品内含物重组之后密封其母连接器117,从而维持无菌条件,而母小瓶适配器110保持直立以备随后使用。或者,图18图示图1的通风的母小瓶适配器110,其具有用于同样目的的预先分离的隔膜126。
图19图示流体转移组合件180,其在构造上类似于流体转移组合件100,但就流体转移组合件180具有与初始重组就绪状态相反的初始重组未就绪状态来说,流体转移组合件180不同于流体转移组合件100。流体转移组合件180包含:母小瓶适配器181,其具有通风布置110A和母连接器117;以及公小瓶适配器182,其具有密封布置130A和公连接器137。母小瓶适配器181可由与注射器10一起使用以进行给药的母小瓶适配器110或与IV装置30一起使用以进行给药的母小瓶适配器171构成。公小瓶适配器182对应地包含形状和尺寸适合的公连接器137。重组未就绪状态和重组就绪状态之间的区别是在前一种状态下公小瓶适配器182从母小瓶适配器181发生轴向移动,从而公连接器137不密封母连接器117并且密封布置130A不密封通风布置110A。
图20图示公小瓶适配器182,其类似于公小瓶适配器130但与其在以下两个方面不同:密封布置130A另外包含一对相对的向内定向的啮合构件183,从而在初始重组未就绪状态下啮合母连接器117,从而将公小瓶适配器182装配在母小瓶适配器181上。此外,公小瓶适配器182包含3个等距间隔的轴向定向的夹持构件184,其在公连接器137的侧面,并且具有向内定向的突出物186,从而在公小瓶适配器向母小瓶适配器发生轴向位移时啮合母连接器的外螺纹117A。
图21图示在公小瓶适配器182搭扣配合至容纳液态药剂27的小瓶20B时的流体转移组合件180。用户施加向下的力F至母小瓶适配器181,致使母小瓶适配器181在轴向上移向公小瓶适配器182。轴向位移致使密封布置130A密封通风口119A以及公连接器137密封母连接器117,从而有效地使流体转移组合件180转变到其重组就绪状态。向内定向的突出物186以类似于公鲁尔锁合连接器的方式啮合外螺纹117A,从而用户从母小瓶适配器181拧松公小瓶适配器182而在最初打开通风配置110A,以便使得能够吸入过滤过的空气并且使公小瓶适配器182与母小瓶适配器181随后完全机械分离。
尽管本发明已相对于有限数量的实施例来加以描述,但应了解,在所附权利要求书的范围内可进行本发明的许多变动、修改以及其他应用。
Claims (10)
1.一种流体转移组合件,其与第一小瓶和第二小瓶一起用于液态药品重组和给药,所述第一小瓶具有小瓶开口和密封所述小瓶开口的小瓶塞以及容纳液态药剂的小瓶内部,所述第二小瓶具有小瓶开口和密封所述小瓶开口的小瓶塞以及在负压下容纳药剂的小瓶内部,所述液态药剂既定重组所述第二小瓶的药剂以形成重组的液态药品内含物,所述流体转移组合件具有纵轴并且包含:
(a)母小瓶适配器,其具有:顶壁;套筒,具有用于搭扣配合至所述第二小瓶的挠曲构件;尖锐插管,用于在将所述母小瓶适配器搭扣配合至所述第二小瓶上时刺穿所述第二小瓶的小瓶塞,所述尖锐插管包含液体转移管腔,所述液体转移管腔用于与所述第二小瓶的小瓶内部建立流体连通;以及与所述液体转移管腔流体连通的母连接器;以及
(b)公小瓶适配器,其具有:顶壁;套筒,具有用于搭扣配合至所述第一小瓶的挠曲构件;尖锐插管,用于在将所述公小瓶适配器搭扣配合至所述第一小瓶上时刺穿所述第一小瓶的小瓶塞,所述尖锐插管包含液体转移管腔,所述液体转移管腔用于与所述第一小瓶的小瓶内部建立流体连通;以及公连接器,其与所述液体转移管腔流体连通并且用于在将所述公小瓶适配器装配至所述母小瓶适配器上时密封所述母连接器以重组所述液态药品内含物,
其特征在于
所述母小瓶适配器具有通风布置,其包含i)在所述顶壁之下的空气过滤器,ii)在所述顶壁中形成的至少一个通风口以及iii)在所述尖锐插管中形成的通风管腔,所述通风管腔用于在将所述母小瓶适配器搭扣配合至所述第二小瓶时,在所述至少一个通风口和所述第二小瓶的小瓶内部之间建立流体连通,以及
所述公小瓶适配器具有密封布置,其用于在重组所述液态药品内含物时密封所述至少一个通风口,
所述布置如此以致在起初i)将所述公小瓶适配器搭扣配合在所述第一小瓶上,并且其后ii)将所述母小瓶适配器搭扣配合在所述第二小瓶上时,所述第二小瓶的负压往其中吸入所述第一小瓶的液态药剂以与其药剂重组以便重组所述重组的液态药品内含物,
所述公小瓶适配器从所述母小瓶适配器发生的随后的轴向位移起初使所述密封布置从所述至少一个通风口发生轴向位移以便打开所述通风布置,而所述公连接器继续密封所述母连接器,从而所述第二小瓶仅向其中吸入过滤过的空气以便均衡其负压,并且其后完成所述公小瓶适配器与所述母小瓶适配器的机械分离,从而使得能够将所述重组的液态药品内含物进行给药。
2.根据权利要求1所述的组合件,其中所述密封布置包含至少一个轴向定向的口密封构件,用于在重组所述液态药品内含物时密封所述至少一个通风口。
3.根据权利要求2所述的组合件,其中所述至少一个轴向定向的口密封构件包含环形口密封构件,其用于在重组所述液态药品内含物时同时密封所述至少一个通风口的至少一个通风口。
4.根据权利要求1至3中任一权利要求所述的组合件,其中所述流体转移组合件是预先装配成初始重组就绪状态,其包含所述公小瓶适配器装配在所述母小瓶适配器之上,所述公连接器密封所述母连接器,并且所述密封布置密封所述至少一个通风口。
5.根据权利要求1至3中任一权利要求所述的组合件,其中所述流体转移组合件是预先装配成初始重组未就绪状态,其包含所述公小瓶适配器装配在所述母小瓶适配器之上,并且所述密封布置从所述至少一个通风口发生轴向位移从而不密封所述通风布置,
所述流体转移组合件要求所述公小瓶适配器向所述母小瓶适配器发生轴向位移,从而推动所述公连接器密封所述母连接器以及所述密封布置密封所述至少一个通风口,从而使所述流体转移组合件从所述初始重组未就绪状态转变到重组就绪状态。
6.根据权利要求5所述的组合件,其中所述密封布置包含至少一个向内定向的啮合构件,其用于在所述初始重组未就绪状态下啮合所述母连接器从而将所述公小瓶适配器装配在所述母小瓶适配器之上。
7.根据权利要求5所述的组合件,其中所述公小瓶适配器包含至少两个轴向定向的夹持构件,所述夹持构件在所述公连接器的侧面并且具有向内定向的突出物,从而在所述公小瓶适配器向所述母小瓶适配器发生所述轴向位移时,啮合所述母连接器的自由端。
8.根据权利要求1至7中任一权利要求所述的组合件,其中所述母连接器包含内部环形密封件,其用于与所述公连接器在重组液态药品内含物时密封啮合并且与IV道钉在液态药品给药时密封啮合。
9.根据权利要求1至8中任一权利要求所述的组合件,其中所述母连接器包含手动放置的顶盖,其用于在所述公小瓶适配器与所述母小瓶适配器的所述完全机械分离后密封所述母连接器。
10.根据权利要求1至9中任一权利要求所述的组合件,其中所述通风布置包含至少一个加罩的通风口,所述通风口具有相对于所述纵轴辐射状面向外部的通风孔。
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Also Published As
Publication number | Publication date |
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IL219792A0 (en) | 2012-07-31 |
EP2512399A1 (en) | 2012-10-24 |
EP2512399B1 (en) | 2015-04-08 |
DK2512399T3 (da) | 2015-06-22 |
US8684994B2 (en) | 2014-04-01 |
BR112012021134A2 (pt) | 2016-05-17 |
BR112012021134B1 (pt) | 2020-01-21 |
JP5416848B2 (ja) | 2014-02-12 |
WO2011104711A1 (en) | 2011-09-01 |
IL219792A (en) | 2015-01-29 |
CN102711712B (zh) | 2014-08-13 |
US20120323210A1 (en) | 2012-12-20 |
JP2013520272A (ja) | 2013-06-06 |
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