CN103874478A - 用于与液体容器和药瓶一起使用的阀门组件 - Google Patents
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Abstract
阀门组件，用于与液体容器和包含药瓶的药剂一起使用，以便实现以液体药品形成为目的的液体内含物从液体容器到药瓶的初始转移，以及以给药为目的的液体药品内含物从药瓶到液体容器的随后转移。液体药品转移装置可以包括预先连接到液体容器的阀门组件。或者，液体药品转移装置可以包括封装在无菌罩包装中的阀门组件，准备在使用前连接到液体容器。
Description
技术领域
本发明涉及用于与液体容器和药瓶一起使用的阀门组件。
背景技术
Aalto等的美国发明专利号4,607,671示出并说明了一种重构设备，用于以在诸如注射用溶液容器的第二容器中的液体来构成标准药瓶中的药品。重构设备包括外壳和安装在外壳内的中空、双端针。该外壳包括具有基本上圆形底座的护套和从底座下垂的外裙。该外裙包括自由端、基本上圆柱形的内表面和外表面。多个向内突出的凸块在内表面周围间隔地隔开。在距离底座基本上相等的距离上布置凸块，该距离基本上等于可锻环带的宽度。
Bonnici等的美国专利号5,304,163示出并说明了一种完整的重构设备，它包括具有给药端口的软质容器和从其延伸的软管。该给药端口包括入口膜，通过它可以插入尖套管，从而进入到所述软质容器的内部。该软管在其中包含易碎的或易破裂的阀门。永久固定到软管末端的是具有基本上圆形底座的护套和末端开口的外裙，其包括从底座下垂的内表面。该外裙包括多个向内突出的凸块，其围绕内表面间隔地隔开，以便密封地接合标准药瓶。将尖套管安装在外裙内，以便刺穿标准药瓶的瓶塞，建立在套管与药瓶内部之间的流体连通。提供可剥离的盖子，在使用前覆盖外裙开口，用以保持设备的无菌条件。在外壳中提供内腔，以建立套管与易碎的或易破裂的阀门之间的流体连通。
Capitaine等的美国专利号8,025,653示出并说明了一种螺旋接头（luer connector）、用于容器的医用接头，该容器具有可刺穿的瓶塞，和包括这个螺旋接头的转移装置。这个螺旋接头包括用于流体通过的内导管、连接到第二螺旋接头的元件，该第二螺旋接头具有穿孔器，这些连接元件放置在其一个末端。这个末端还包括在导管中形成突起的连续的边缘，以便以耦合这些接头为目的的在将穿孔器引入导管中时在其上提供密封。易破的膜也放置在导管中，以便在所述第二螺旋接头耦合到这个螺旋接头时被分割开。
发明内容
本发明针对阀门组件，用于与液体容器和包含药瓶的药剂一起使用，以便实现以液体药品形成为目的的液体内含物从液体容器到药瓶的初始转移，以及以给药为目的的液体药品内含物从药瓶到液体容器的随后转移。液体容器可以是瓶子、IV包等。该液体容器通常包括双进入端口。液体内含物重构粉末药剂，或者稀释包含在药瓶中的液体药剂。
阀门组件包括具有套管和外螺纹接头的传统药瓶转接器，以及进入端口转接器，其具有用于密封插入到双进入端口中一个的进入端口接头，和用于密封安装到外螺纹接头上的内螺纹接头。将药瓶转接器在关闭位置与打开位置之间相对于进入端口转接器手动地往复运动，该关闭位置用于阻止液体容器内含物与药瓶之间的流体连通，该打开位置用于实现液体容器内含物与药瓶之间的流体连通。
除其他的之外，手动往复运动装置（manual reciprocal arrangement）可以包括螺纹装置、推拉装置等。该往复运动装置实现了液体内含物从药瓶转移到液体容器后阀门组件的密封，以避免从液体容器到药瓶的漏滴或泄漏。该往复运动装置还阻止了密封的破裂，由此确保了在转移液体内含物时，没有密封碎片或颗粒与药瓶内含物混合。
外螺纹接头优选地是外螺旋锁接头（male Luer lock connector）。可以从West Pharmaceutical Services,Inc.Lionville,PA19341,USAwww.westpharma.com商业购买到具有外螺旋锁接头的适合的药瓶转接器。该药瓶转接器可以实现为不排气和可排气形式。该阀门组件优选地预先连接到液体容器，以形成液体药品转移装置，该液体药品转移装置具有安装在其套管上的可移除的密封件，用于确保直到使用时的无菌条件。或者，液体药品转移装置可以包括封装在无菌罩包装中的阀门组件，准备在使用前连接到液体容器。
附图说明
为了理解本发明，并了解它在实际中如何实施，现在将参考附图来说明优选实施例，其仅是作为非限制性实例，在附图中，为相似的部件给与类似的编号，其中：
图1是液体药品转移装置的图示，包括预先连接到IV包以便与药瓶一起使用的本发明的阀门组件的第一优选实施例；
图2是包括药瓶转接器、进入端口和密封件的阀门组件的分解图；
图3是沿图2中的线B-B阀门组件的纵截面图，显示了按扣装配在药瓶上的药瓶转接器；
图4是沿图2中的线C-C进入端口转接器的纵截面图；
图5是沿图2中的线D-D进入端口转接器的横截面图；
图6A是沿图1中的线A-A在其关闭位置的阀门组件的纵截面图；
图6B是沿图1中的线A-A在其打开位置的阀门组件的纵截面图；
图7A-7F是显示图1的液体药品转移装置的使用的图示；
图8是用于在使用前连接到IV包的本发明的阀门组件的第二优选实施例的图示；
图9是用于在使用前连接到IV包的本发明的阀门组件的第三优选实施例的图示；
图10是沿图9中的线E-E图9的阀门组件的纵截面图；
图11A是用于连接到具有双进入端口的液体容器的本发明的阀门组件的第四优选实施例的图示；及
图11B是图11A的液体容器的俯视图。
具体实施方式
图1显示了液体药品转移装置100，用于与药瓶10一起使用。液体药品转移装置100包括由IV包构成的液体容器20和预先连接到IV包20的阀门组件30A。药瓶10具有药瓶纵轴10A，包括药瓶体11，具有药瓶边缘12，窄直径瓶颈13位于药瓶体11与药瓶边缘12之间。药瓶边缘12限定了药瓶开口14，其由药瓶瓶塞16气密密封，并由环带17覆盖。药瓶体11限定了药瓶内部18，包含粉末或者液体药品内含物19。IV包20包括第一进入端口21、第二进入端口22和液体内含物23。进入端口21和22是塑料管道的形式。进入端口21通常装配了自密封塞子24（显示为移除了），设计用于将注射器内含物针头注射到IV包20中。进入端口22通常由旋摘帽26密封，用于给药目的的IV尖端的插入。
图2到6显示了阀门组件30A，包括药瓶转接器40、预先连接到第一进入端口21的进入端口转接器60和密封件90。药瓶转接器40可以相对于进入端口转接器60在关闭位置（见图6A）和打开位置（见图6B）之间手动旋转。提供在关闭位置的阀门组件30A以避免液体内含物23从IV包20滴漏。暂时打开阀门组件30A，以实现液体内含物从IV包20到药瓶10的初始转移，以及在重新关闭前的液体药品内含物从药瓶10到IV包20的随后转移。在液体药品内含物经由给药端口22到病人的给药过程中，空药瓶10优选地保留安装在药瓶转接器40中，但也可任选地从其断开连接。
药瓶转接器40具有药瓶转接器纵轴40A，且包括具有横切药瓶转接器纵轴40A的上壁42的药瓶转接器体41，具有多个弯曲件44的下垂喇叭形外裙43，用于按扣装配到药瓶10上，具有套管尖端47的尖的管形套管46，用于刺穿药瓶塞子16，和与套管46流体连通的流体连通腔48。相对套管46，流体连通腔48在安装在上壁42上的垂直的外螺纹接头49中终止。外螺纹接头49具有环形外螺纹接头边缘51。外螺纹接头49与锁环52一起构成，锁环52具有内螺纹53和一对相反的外围槽54。外围槽54每一个都具有在约45°与约90°之间的扇形角，用以界定在药瓶转接器40与进入端口转接器60之间的旋转。
进入端口转接器60具有进入端口转接器纵轴60A，旨在与药瓶转接器纵轴40A同向，且优选地与其同轴。进入端口转接器60包括具有内腔62的管形主体61，用于密封插入到进入端口21中的进入端口接头63和用于密封安装到外螺纹接头49上的内螺纹接头64。内螺纹接头64具有外螺纹66的远端64A，用于与内螺纹53螺纹接合。内腔62包括在进入端口接头63与内螺纹接头64之间的中间位置的横档67。横档67具有朝向进入端口接头63的横档上侧67A和朝向内螺纹接头64的横档下侧67B，。横档67包括四个等间距的纵向贯穿膛孔68，在邻近主体61的周边布置。横档下侧67B与密封突起69一起构成，用于在外螺纹接头49处选择性密封插入到流体连通腔48中。
进入端口转接器60包括一对纵向定向腿71，每一个都具有向内定向的朝向外螺纹66的突起72，用于插入到外围槽54中。进入端口转接器60包括一对相反的径向定向翼73，用于帮助药瓶转接器40相对于进入端口转接器60的手动旋转。翼73具有最上方的翼面73A。内螺纹接头64的一对纵向定向腿71与其相应的向内定向的突起72可在锁环52的一对外围槽54中，在第一极限位置与第二相反极限位置之间旋转，第一极限位置对应于阀门组件30A的关闭位置（见图6A），第二相反极限位置对应于阀门组件30A的打开位置（见图6B）。
在关闭位置中，环形外螺纹接头边缘51抵靠在横档下侧67B上，用以密封周边贯穿膛孔68，以便密封内腔62，用于阻止在IV包20与药瓶10之间的流体连通。密封突起69在关闭位置中，在外螺纹接头49处密封插入到流体连通腔48中，以确保没有液体通过内腔62泄漏。最上方翼面73A限定了关闭位置中的相对于参考面S的高度H1。由向内定向的突起72在外围槽54内的移动来界定的药瓶转接器40相对于进入端口转接器60的手动松开旋转使得环形外螺纹接头边缘51从横档下侧67B移位，用以在打开位置开启周边贯穿膛孔68，以便开启内腔62，用于实现在进入端口接头63与内螺纹接头64之间的流体连通（见图6B）。最上方翼面73A限定了打开位置中的相对于参考面S的高度H2，在此H2 > H1。高度差H2 – H1通常在约1mm的范围中，并且取决于药瓶转接器40与进入端口转接器60的螺纹螺距和外围槽54的扇形角。
密封件90包括横跨外裙43延伸的固定件91和垂直安装在固定件91上的套筒92，用于在套管46上的密封安装。固定件91包括用于装配到相对的弯曲件远端的狭缝93。密封件90包括防篡改证据箔（tamper proofevidence foil）94，用于指示使用前阀门组件30A的完整性。
图7A到7F显示了液体药品转移装置100的使用如下：
图7A显示了阀门组件30A在其关闭位置中，并以安装在药瓶转接器40上的其密封件90来装配。图7A还显示了按箭头A所示地去除密封件90，以在按箭头C所示地将药瓶10按扣装配插入到药品转接器40之前露出套管46（见图7B）。去除密封件90使得证据箔94从药瓶转接器40断开连接，如箭头B所示的。
图7C显示了药瓶转接器40与其安装的药瓶10一起按箭头D所示地相对于进入端口转接器60的手动松开旋转，用于推进阀门组件30A从其关闭位置到达其打开位置，以便实现从IV包20到药瓶10的流体连通，用于从前者到后者的液体内含物的转移。
图7D显示了在液体药品转移装置100的搅动之前，挤压IV包20以便如箭头E所示，将液体内含物转移到药瓶10中，以在药瓶10中形成液体药品内含物。
图7E显示了液体药品转移装置100的倒置，用于在药品转接器40及其安装的药瓶按箭头G所示地相对于进入端口转接器60的手动紧固旋转，以便关闭阀门组件30A之前，将液体药品内含物如箭头F所示从药瓶10转移到IV包20。
图7F显示了在打开旋摘帽26，以便将液体药瓶内含物给与病人之后，液体药品转移装置100的倒置，和输液装置插入到第二进入端口22中。
图8到11显示了三个阀门组件30B、30C和30D，在结构和操作上与阀门组件30A类似，因此类似地标号了相似部分。
阀门组件30B和30C显示为与IV包20一起使用，IV包20具有装配有自密封塞子24的第一进入端口21和装配有旋摘帽26的第二进入端口22，。阀门组件30B、30C和30D旨在作为无菌泡罩包装31中的分立项来提供，因此无需密封件90。
图8显示了阀门组件30B，包括用于在进入端口21上贴合地滑动的护罩32和用于刺穿自密封塞子24的针33。局部破裂地显示了护罩32，以显示针33。
图9和10显示了阀门组件30C，包括推拉式往复运动装置，用于实现药瓶转接器40相对于进入端口转接器60的手动线性往复运动，以便在关闭位置与打开位置之间布置阀门组件30C。阀门组件30C包括双组件进入端口转接器80，具有带有进入端口接头63的前导进入端口转接器组件81，用于密封插入到进入端口中，和拖尾进入端口转接器组件82，其具有内螺纹接头64，用于在外螺纹接头49上的密封安装。拖尾进入端口转接器组件82与药瓶转接器40整体成形。除了其他的以外，用于将拖尾进入端口转接器组件82整体安装到药瓶转接器40上的合适的结合手段包括胶粘、超声等。
前导进入端口转接器组件81包括横切密封突起84的一对纵向内腔83。拖尾进入端口转接器组件82包括与内腔62流体连通的纵向内腔86。在阀门组件30C的关闭位置中，密封突起84密封内腔86，用于阻止IV包与药瓶之间的流体连通。在阀门组件30C的打开位置中，密封突起84布置在内腔86上，用于实现内腔83与内腔86之间，以及因此IV包与药瓶之间的流体连通。
图11A和11B显示了与液体容器20一起使用的阀门组件30D，液体容器20由瓶子组成且具有双进入端口21和22。阀门组件30D类似于阀门组件30A，但包括进入端口尖端34，用于密封滑动插入到一个端口21和22中。
尽管相对于有限数量的实施例说明了本发明，但会意识到，可以在所附权利要求书的范围内，做出本发明的许多变化、修改及其他应用。
Claims (9)
1.一种阀门组件，用于与液体容器和药瓶一起使用，所述液体容器包括双进入端口，并包含液体内含物，所述药瓶具有药瓶瓶塞和包含药剂的药瓶内部，所述阀门组件包括：
(a)药瓶转接器，该药瓶转接器具有药瓶转接器纵轴，且包括药瓶转接器体，该药瓶转接器体具有横切所述药瓶转接器纵轴的上壁，具有套管尖端的尖的管形套管，用于刺穿所述药瓶瓶塞，以便在将所述药瓶转接器安装到所述药瓶上时，建立与所述药瓶内部的流体连通，及相对所述套管，安装在所述上壁上的垂直的外螺纹接头，并与之流体连通，所述外螺纹接头具有最上方环形外螺纹接头边缘；以及
(b)进入端口转接器，该进入端口转接器具有与所述药瓶转接器纵轴同向的进入端口转接器纵轴，且包括进入端口接头和内螺纹接头，该进入端口接头用于密封插入到一个进入端口中，该内螺纹接头用于密封安装到所述外螺纹接头上，
所述药瓶转接器相对于所述进入端口转接器在关闭位置与打开位置之间手动地往复运动，所述关闭位置用于阻止所述液体容器与所述药瓶之间的流体连通，所述打开位置用于实现所述液体容器与所述药瓶之间的流体连通。
2.根据权利要求1所述的组件，其中，所述药瓶转接器包括在所述外螺纹接头的外围的锁环，所述锁环具有至少两个外围槽，
所述进入端口转接器包括相应数量的纵向定向腿，每一个都具有向内定向的突起，用于插入到所述至少两个外围槽中，以使得所述药瓶转接器在所述关闭位置与所述打开位置之间相对于所述进入端口转接器手动旋转地往复运动，
所述进入端口转接器进一步包括内腔，用于在所述进入端口接头与所述内螺纹接头之间的流体连通，所述内腔具有横档，其具有至少一个周边贯通膛孔，用于实现所述进入端口接头与所述内螺纹接头之间的所述流体连通，
所述药瓶转接器推进所述环形外螺纹接头边缘靠在所述横档上，以密封所述至少一个周边贯通膛孔，用于在所述关闭位置中密封所述内腔，在所述打开位置中，将所述环形外螺纹接头边缘从所述横档移位，以开启所述至少一个周边贯通膛孔。
3.根据权利要求2所述的组件，其中，所述进入端口转接器包括密封突起，用于在所述关闭位置中，在所述外螺纹接头处密封插入到所述流体连通内腔中。
4.根据权利要求2所述的组件，其中，所述进入端口转接器包括至少一个径向定向的翼，用于帮助所述药瓶转接器相对于所述进入端口转接器的所述手动旋转。
5.根据权利要求1所述的组件，其中，所述进入端口转接器具有双部件结构，该双部件结构包括具有所述进入端口接头的前导进入端口转接器组件和拖尾进入端口转接器组件，其具有所述内螺纹接头，用于在所述外螺纹接头上的密封安装，所述拖尾进入端口转接器组件与所述药瓶转接器整体成形，
所述药瓶转接器沿所述药瓶转接器纵轴，在所述关闭位置与所述打开位置之间向所述前导进入端口转接器组件手动地线性往复运动，所述关闭位置用于阻止所述外螺纹接头与所述进入端口接头之间的流体连通，所述打开位置用于实现所述液体容器与所述药瓶之间流体连通。
6.根据权利要求1至5任意一项所述的组件，用于到所述液体容器的预先连接，并进一步包括用于可移除的安装在所述套管上的密封件。
7.根据权利要求6所述的组件，其中，所述密封件包括横跨所述外裙延伸的固定件，和垂直安装在所述固定件上的套筒，用于在所述套管上的密封安装。
8.根据权利要求6所述的组件，其中，所述密封件包括在所述密封件与所述药瓶转接器之间延伸的防篡改证据箔，用于指示所述密封件从所述药瓶转接器的去除。
9.一种液体药品转移装置，包括液体容器，其具有预先连接的根据权利要求1到8任意一项所述的阀门组件。
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- 2012-10-10 BR BR112014008551-0A patent/BR112014008551B1/pt active IP Right Grant
- 2012-10-10 CN CN201280048616.5A patent/CN103874478B/zh active Active
- 2012-10-10 US US14/345,094 patent/US8905994B1/en active Active
- 2012-10-10 EP EP12781466.3A patent/EP2736478B1/en active Active
- 2012-10-10 DK DK12781466.3T patent/DK2736478T3/da active
- 2012-10-10 JP JP2014535227A patent/JP5635219B2/ja active Active
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| CN109475467A (zh) * | 2016-09-26 | 2019-03-15 | 泰尔茂株式会社 | 药液填充装置以及药液填充方法 |
| CN113301882A (zh) * | 2019-01-22 | 2021-08-24 | 巴克斯特国际公司 | 利用集成的通气导管经由高真空小瓶给药药物的重构系统 |
Also Published As
| Publication number | Publication date |
|---|---|
| DK2736478T3 (da) | 2016-02-15 |
| WO2013054323A1 (en) | 2013-04-18 |
| BR112014008551B1 (pt) | 2021-02-23 |
| JP5635219B2 (ja) | 2014-12-03 |
| BR112014008551A2 (pt) | 2017-04-18 |
| US8905994B1 (en) | 2014-12-09 |
| US20140352845A1 (en) | 2014-12-04 |
| IL231307A0 (en) | 2014-04-30 |
| IL215699A0 (en) | 2011-12-29 |
| JP2014528345A (ja) | 2014-10-27 |
| IL231307A (en) | 2017-05-29 |
| EP2736478B1 (en) | 2015-12-30 |
| EP2736478A1 (en) | 2014-06-04 |
| CN103874478B (zh) | 2015-04-22 |
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