CN101299983B - 无针式附加剂控制阀 - Google Patents

无针式附加剂控制阀 Download PDF

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CN101299983B
CN101299983B CN2006800404672A CN200680040467A CN101299983B CN 101299983 B CN101299983 B CN 101299983B CN 2006800404672 A CN2006800404672 A CN 2006800404672A CN 200680040467 A CN200680040467 A CN 200680040467A CN 101299983 B CN101299983 B CN 101299983B
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弗莱迪·辛格
伊高·丹那贝尔格
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West Pharma Services IL Ltd
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Abstract

一用于流体容器、含有输液液体的输液器和并有一管理输入液体的无针附加剂控制阀，以及一包含液体附加剂和有一管理液体附加剂***连接器的附加剂传输装置。附加剂控制阀有一个三叉形连接体，该连接体包括一个用于密闭式***输液器静脉输液口或给药口的静脉输液穿刺器，一个用于密闭地接受附加剂传输装置的静脉穿刺器的替代静脉输液口，和一个用于密封第接受附加剂传输装置的***连接器的接受连接器的通常是关闭的(NC)无针附加剂端口。静脉输液穿刺器、替代静脉输液口、以及通常是关闭的无针附加剂端口是三通的且具有连续式流体连通，这样，附加剂传输装置的液体附加剂既能与输入液体混合又能直接被给病人。

Description

无针式附加剂控制阀
技术领域
本发明涉及与含一输液液体且具有一个用于输液给药的静脉输液口或给药口(intravenous(IV)or administration port)的输液器(fluid container)一同使用的附加剂(添加剂)控制阀。 
背景技术
常规的输液袋具有一个用于与输液器(infusion set)，滴注器(drip Chamber)和穿刺器(spike)互连的静脉输液口或给药口，和一个用于以针注射方式注入液体附加剂的自闭式给药口。然而，注射针***输液袋的给药口时会无意中将给药口的刮擦物混入输液袋的注射剂中。此外，一些注射针备有管套用以防止***(needle sticks)，但这也阻止了注射针***给药口，因此限制了某些具有保护套的注射针和具有特殊加药口的输液袋的配合使用，增加了给患者用药的复杂性。 
被授予米尔德等人(Millerd et al.)的美国专利第4,581,014号展示和描述了一种输液***，该***可中断给患者的第一种输液液体以让第二种输液液体输入，然后再继续第一种输液液体的流入。该输液***包括一个选择阀(12)，阀上有一个用来刺穿输液袋静脉输液口(25)的直立的第一穿刺器(36)，一个用于刺穿小药瓶自封闭橡胶塞的通常是直立的双路径第二穿刺器(44)，和一个用于连接到滴注器上方末端的出口接头(54)。 
被授予黑博等人(Haber et al.)的美国专利第5,647,845号展示和描述了一种通用静脉输液***，该***能将定制的或普通的液态或粉末状药物与输液袋中的流动内容物混和，而混合剂可依具患者的需要控制。该通用静脉输液***含有一个具有给药口管套(14)的药液控制阀(2)，一个药瓶回收与安置容器(20)，一个用于配接常规静脉注射液管的、有一注射液端口(19)的静脉滴注器输液管(18)。 
发明内容
本发明的目的是提供一种与一含由输液液体的输液器和一含有液体附加剂的附加剂传输装置一起使用的无针附加剂控制阀，它用于将液体附加剂与输液液体混合或直接给患者用药。上述附加剂控制阀有一个三叉形连接体，该连接体包括一个用于密闭式***输液器静脉输液口或给药口的静脉输液穿刺器(IV spike)，一个用于密闭地接受静脉穿刺器的替代静脉输液口(substitute IV port)，和一个用于与附加剂传输装置选择性液体连接的、通常是关闭的无针附加剂端口(needleless additive port)。静脉输液穿刺器、替代静脉输液口、以及通常是关闭的无针附加剂端口是三通的且具有连续式流体连通。本发明的 无针式附加剂控制阀提供了一种可用于具有***连接器(male connector)的常规附加剂传输装置的简单且低成本的装置，并可通过静脉输液装置、滴注器、穿刺器和类似装置连通到输液器。理想的***连接器为滑动形或锁定形的***式露尔连接器(male Luerconnectors)。 
附图说明
为了更好的理解本发明并领会如何实施本发明，现将结合附图说明理想的实施方案，但本发明并不局限于这些例案；在附图中，同类部件被给与相同的编号。 
图1为输液袋，无针式附加剂控制阀，注射器，药瓶接头和药瓶的示意图； 
图2A为带有自闭性通路阀的无针式附加剂控制阀的前视图； 
图2B为自闭式通路阀的前视图； 
图3A为沿图2A中的剖线A-A的自闭性通路阀在关闭状态时的剖面图； 
图3B为沿图2A中的剖线A-A的自闭性通路阀在开放状态时的剖面图； 
图4A与图4B展示了与包含液体附加剂的注射器同用的无针式附加剂控制阀的使用； 
图5A与图5B展示了与安装在含有液体附加剂的药瓶上的药瓶接头同用的无针式附加剂控制阀的使用。 
具体实施方式
图1显示了一个含输液液体并且具有一静脉输液口或给药口(intravenous(IV)oradministration port)11和一附加剂端口(additive port)12的常规输液袋10，一个无针式附加剂控制阀13，以及一个具有***式露尔锁定形连接器(male Luer lockconnector)16的附加剂传输装置14。附加剂传输装置14可由注射器17，以扣合式套入固定于药瓶19上的药瓶接头18，及类似的装置组成。具有与之整体成型用于刺穿药瓶橡皮塞的刺穿部件的适宜药瓶接头18，可从以色列若纳纳的美迪摩普药品公司(Medimop MedicalProjects Ltd.，Ra’anana，Israel)(www.medimop.com)购买。药瓶19可装有液体附加剂或是在给药前需与稀释液重构的冻干的粉末状药品。 
图2显示了有一三叉形连接体21的无针式附加剂控制阀13。该三叉形连接体21有一个可密封***静脉输液口11的静脉输液穿刺器(IV spike)22。该静脉输液穿刺器22由合适的硬塑料材料制成，如聚碳酸酯及类似物。静脉输液穿刺器22包括一个成锥形的顶端23，其上有排列于外周的孔洞24；一个内腔26；和一个出口孔(outlet aperture)27。该静脉输液穿刺器22是作为一个注塑成型的单块集成结构，与用于限制***静脉输液口11的圆形凸缘28和朝向出口孔27、通常是关闭的无针附加剂端口(needleless additive port)29一起整体成型的。 
无针附加剂端口29有一内腔31并配置有一个用于以螺纹扣纹式接受***式露尔连接器16的自闭性通路阀32。自闭性通路阀32通常由硬透明塑料材料制成，如聚碳酸酯及类似物，它具有包括邻近表面34和轮缘36的阶梯状外表面33。自封闭通路阀32内有硅橡胶自闭式阀部件37，该部件具有管状主要部件38和圆柱形无针入口部件39。无针入口部件39具有外露的入口表面41和从其延伸的预制缝42。自闭式阀部件37有一自然长度L1，它被制成入口表面41是与邻近的轮缘36齐平这样的长度，这样入口表面41可以容易地实施灭菌目的的拭抹(请参阅图3A)。***式露尔连接器16以螺纹旋于通路阀32上，其前进直致紧靠邻近表面34。在前进的过程中，***式露尔连接器16将阀部件37压缩致受压长度L2＜L1，这使得入口部件39沿预制缝42分开，从而实现附加剂传输装置与内腔31之间的流体连通(请参阅图3B)。
三叉形连接体21包括一个连接到出口孔27、有内腔44和密封膜46的替代静脉输液口43。替代静脉输液口43是由诸如PVC等合适的软塑料材料制成的常规静脉输液口，它用于密封地接入直径为5mm到6mm的静脉输液穿刺器(未显示)。 
图4A与图4B显示了与输液袋10和注射器17同用的无针式附加剂控制阀13的使用。注射器17可事先充入液体附加剂。或者，注射器17也可充入由药瓶中的冻干粉状药品重构的液态药物。重构的液态药物也可以是与从输液袋吸入的液态内容物重构成的。注射器17可用于在给患者输液前将液体附加剂注入输液袋10，或在输液过程中将液体附加剂输入患者。 
图5A与图5B显示了与输液袋10和安装在药瓶19上的药瓶接头18同用的无针式附加剂控制阀13的使用。如果药瓶19含有液体附加剂，药瓶19中的药品可在给患者输液前混入注射液，或在输液过程中给患者用药。如果在药瓶19包含冻干粉末状药品，可通过挤压输液袋10使液体从输液袋10进入药瓶19来重构粉状药品。药瓶19中全部药物的重构过程可能需要多次稀释液的对冲。 
虽然我们已通过有限的实施例对本发明进行了描述，必须认识到在附加的权利要求书的范围内，还可对本发明作出许多变型、改造和其它的应用。例如，所述自闭性控制阀可由诸如手动操作的活栓之类的部件替代。 
虽然我们已通过有限的实施例对本发明进行了描述，必须认识到在附加的权利要求书的范围内，还可对本发明作出许多变型、改造和其它的应用。例如，所述自闭性控制阀可由诸如手动操作的活栓之类的部件替代。 

Claims (5)

1.一种无针式附加剂控制阀，该控制阀是与一含输液液体且具有用于输液给药的静脉输液口的输液容器，及一含液体附加剂且具有用于液体附加剂投药的***连接器的附加剂传输装置一同使用的；该无针式附加剂控制阀包括一三叉形连接体，该三叉连接体含有：一用于密封***静脉输液口的静脉输液穿刺器，一用于密封接入静脉输液穿刺器的替代静脉输液口，和一通常是关闭的无针附加剂端口，该端口有一用于密封接受在附加剂传输装置上的***连接器的无针入口部件；
一在所述静脉输液穿刺器内的第一内腔，以及
一在所述无针附加剂端口内的第二内腔，由此保持液体流通，使得上述静脉输液穿刺器，替代静脉输液口以及通常是关闭的无针附加剂端口是三通的且具有连续式流体连通，由此可将附加剂传输装置中的液体附加剂与输液液体混合或直接输入患者体内。
2.如权利要求1所述的阀，其特征在于：上述的无针附加剂端***一外露的无针通路表面，在该表面可实施为***连接器的多次无菌封闭***而做的消毒。
3.如权利要求2所述的阀，其特征在于：上述的无针附加剂端***一自闭性通路阀，密封式***连接器可促使该自闭性通路阀从关闭状态转为开放状态。
4.如权利要求1到权利要求3中任一条中所述的阀，其特征在于：上述的***连接器是以螺纹旋转固定于上述无针附加剂端口上的。
5.如权利要求1所述的阀，其特征在于：上述的静脉输液穿刺器与上述的无针附加剂端口为一注塑成型的塑料单块集成结构。
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WO2007052252A1 (en) 2007-05-10
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CA2625824A1 (en) 2007-05-10
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