CN101801329A - 适用于带有加宽端部接头的注射器的液体药物输送装置 - Google Patents
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Abstract
液体药物输送装置,包括一具有一用于密封接受一注射器的注射器通道的壳体,所述注射器具有一在末端具有一加宽端部接头的注射器端部,和一具有一用于卡合接受一小瓶的小瓶适配器的小瓶接受器通道,和一用于施用液体药物的药物给药通道。所述小瓶适配器是用来在混合步骤后被旋转脱离以与用完的小瓶一起被丢弃。所述注射器通道还包括一用于在正常使用包括为重新溶解而振摇的情况下固定所述注射器以预防由于疏忽的注射器脱离的一次性锁紧机构。所述药物给药通道具有一端部接头,所述端部接头优选地与注射器的加宽端部接头相似并具有相同的预防具有母螺旋接头的常规针头在其上滑动安装的作用。
Description
发明领域
本发明涉及一适用于具有加宽端部接头(distal tip)的注射器的液体药物输送装置,用于防止带有母螺旋接头(female Luer connector)的常规针头在其上滑动安装。
发明背景
共同拥有的PCT国际申请号No.PCT/IL2005/000376,标题为液体药物输送装置和针头套移除装置,并以PCT国际公布号No.WO2005/105014公布的国际申请,图解并描述了一包括一具有弹性管的小瓶转接器(vial adapter)的液体药物输送装置,用于制备一装有重新溶解配制的液体药物的带有加宽端部接头的注射器,以用于对患者立即给药(参见WO2005/105014的图8至11)。该加宽端部接头被加工成需要的尺寸以防止常规针头在其上滑动安装。该弹性体管的自由端是用于被封密地延展覆盖在注射器的加宽端部接头上,以实现注射器和装有需要重新溶解的药剂的药品瓶之间的流体连接。重新溶解配制通常需要摇动所述液体药物输送装置、小瓶和注射器的组装件,这可能会导致因不注意而使注射器脱离,内容物泄露。
发明内容
本发明主要提供液体药物输送装置,以安全/稳固地制备一装有重新溶解配制的液体药物的带有加宽端部接头的注射器,用来对患者立即给药。本发明是以具有可旋转拆卸的小瓶转接器的流体调节装置(如属于同一受让人Zinger等的序列号为No.6,238,372的美国专利的图11至15中图示说明和描述)为依据,并包括如下两个改进之处:第一,本发明所述液体药物输送装置包括一具有一弹性密封元件的注射器通道(syringe port),用于与具有加宽端部接头的注射器的流体密封地连接,以及一一次性使用的锁紧机构(single use lockingmechanism),以便与在包括重新溶解配制溶液所需的摇动下的正常使用下保证其防止由于疏忽的注射器脱离,以及第二,本发明所述液体药物输送装置包括一具有一加宽端部接头的给药通道,所述加宽端部接头优选与注射器加宽端部接头相似,也具有相同的目的:预防具有母螺旋接头的常规针头在其上滑动安装。
注射器通道可包括任意合适的用于实现与注射器加宽端部接头的密封流体连接的密封机构。合适的密封机构包括尤其是(inter alia)与WO2005/105014的液体药物输送装置相似的弹性管,用于紧密地伸展覆盖在注射器的加宽端部接头上,一与注射器加宽端部接头被密封地强迫接触的弹性垫圈等等。所述一次性使用的锁紧机构优选地通过提供一个或多个制动元件(stopping members)用以卡住注射器加宽端部接头的后面以环绕(encircle)其注射器端,从而阻止由于疏忽的注射器脱离。当注射器滑动插入注射器通道时所述一次性使用锁紧机构最好被自动地推动(actuated)。或者,一次性使用锁紧机构可以由使用者推动。
附图简要说明
为了理解本发明,并理解其实际上是如何实施的,现将结合附图说明优选的实施方案,但本发明并不局限于此,在附图中,相同部件被给予相同的编号,其中:
图1A对应于前述共同拥有的WO 2005/105014的图8,显示了一包括一具有弹性管的小瓶转接器的液体药物输送装置,用于制备一装有重新溶解配制的液体药物的注射器,以用于对患者立即给药;
图1B对应于前述共同拥有的WO 2005/105014的图9,显示了图1A的液体药物输送装置沿图1A中的A-A线的纵向横截面示意图;
图2为如前述属于同一受让人的申请号为No.6,238,372的美国专利的图11至15中所述注射器、小瓶和流体调节装置的图片描述;
图3是图2的流体调节装置的分解图;
图4是图2的流体调节装置在重新溶解配制的流量控制位置,沿图2中的B-B线的纵向横截面示意图;
图5是图2的流体调节装置在小瓶转接器脱离后的给药流量控制位置,沿图2中的B-B线的纵向横截面示意图;
图6是本发明的包括一具有弹性管的注射器通道和一自动一次性使用锁紧机构的液体药物输送装置的第一优选实施例的侧视图,输送装置是与一具有加宽端部接头的注射器一起使用,以安全稳固地制备所述装有重新溶解配制成原来浓度的液体药物的注射器;
图7是图6的注射器通道的分解图;
图8是图6的液体药物输送装置和一具有加宽端部接头的注射器的组装的侧视图;
图9是图6的液体药物输送装置的立体图,该液体药物输送装置具有一密封垫圈,而不是所述弹性管;
图10是图9的液体药物输送装置和一具有加宽端部接头的注射器的组装的侧视图;
图11是本发明的包括一具有弹性管的注射器通道和一手动一次性使用锁紧机构的液体药物输送装置的第二优选实施例的透视图;
图12是显示图11的手动一次性使用锁紧机构的手动引动的透视图;
图13是本发明的包括一具有弹性管的注射器通道和一可选择的一次性使用锁紧机构的液体药物输送装置的第三优选实施例的透视图。
本发明优选的实施例的具体说明
图1A显示了注射器10、小瓶16和用于液体药物重新溶解配制的液体药物输送装置20。所述注射器10包括一具有一柱塞12的筒11和一注射器端部13,所述注射器端部13的末梢具有一加宽端部接头14,用于防止一具有母螺旋接头的常规针头在其上滑动安装。所述端部接头14具有一外径D1、长度L1和一环形后表面15(annular trailing surface)。所述注射器10典型地包括一稀释剂,用于重新溶解一装在小瓶16中的粉末状药物或混合稀释一装在小瓶16中的液体药物。所述小瓶16包括一顶部开口的瓶子17,该瓶子17采用一由一金属带19盖封的橡皮塞18来密封。
图1A和1B显示了该液体药物输送装置20包括一小瓶转接器21,该小瓶转接器21具有一顶壁22、一用于与所述小瓶16卡合的弹性可变形的开裂的裙部23(slitted skirt)和一用于穿刺所述小瓶的橡皮塞18的空心穿刺元件24,以及一与所述穿刺元件24流体连接的弹性管26。所述弹性管26具有一用于密封地安装在所述端部接头14上以实现所述注射器10和所述小瓶16之间的流体连接的端部27(distal end)。所述弹性管26具有一内径D2,其中D2>D1,和一以其与所述小瓶转接器21的连接点为起始的任意长度L2,其中L2>L1,以便在没有撕裂、破裂等情况下能优选地被密封地延伸覆盖整个所述端部接头14。所述弹性管26优选地由以下材料中的一种构成:PVC、硅酮、橡胶等。
图2至5显示一适用于一常规的具有一公螺旋锁紧接头29的注射器28和一小瓶16的常规的流体调节装置30,以实现液体药物重新溶解然后给药的目的。所述流体调节装置30包括一壳体31,所述壳体31具有一纵轴32、一注射器通道33和一与所述纵轴32同方向的药物给药通道34以及一位于所述注射器通道33和药物给药通道34中间的管状小瓶转接器通道36。所述注射器通道33包括一与所述小瓶转接器通道36流体连接的管状内腔37(1umen),并可滑动地接纳所述注射器28。所述药物给药通道34包括一与所述小瓶转接器通道36流体连接的管状内腔38,目的是用于液体药物给药。
所述小瓶转接器通道36具有一外圆柱面39,该外圆柱面39具有一带有一对相对的四分之一圈(quarter turn)的螺纹42的最下方的部分41。所述小瓶转接器通道36支撑一流量调节元件43,所述流体调节元件可绕通常垂直于所述纵轴32的自转轴44旋转。所述流量调节元件43具有一L型混合流动通道46(mixing flow channel),所述混合流动通道46包括一用于在混合流动调节位置对准所述注射器通道的管状内腔37的径向部分47(radial section),和一末端具有一直径方向的插槽49的轴向部分48(axial section)。所述流量调节元件43具有一末端为半圆形圆周面的给药流动通道51,用于在相对于其混合流动调节位置的转动四分之一圈后的给药流量调节位置时对准所述注射器通道的管状内腔37和所述药物给药通道的管状内腔38。
所述流体调节装置30包括一具有一用于伸缩地接受小瓶的裙部54的小瓶适配器53。所述裙部54具有一顶部表面56,所述顶部表面56具有一对相对的螺纹元件57,用于螺纹连接所述螺纹42,从而将所述小瓶适配器53与所述壳体31连接。所述裙部54还具有六个向下的悬着的弯曲元件58(depending flex members),用于与所述小瓶16卡接。所述小瓶适配器53包括一直立的逐渐变细的空心插头59,用于密封地插入到所述流量调节元件的轴向部分48,以及一对楔61,用于插入所述流量调节元件的插槽49,以连接所述小瓶转接器53和所述流量调节元件43。所述小瓶转接器53包括一向下的悬着的空心插管62(downward dependinghollow cannula),用于穿刺所述小瓶的橡皮塞18并伸入小瓶内。所述插头59与所述插管62是流体连接。
图4和图5显示所述流体调节装置30的操作过程:
图4显示所述流体调节装置30与所述小瓶适配器53连接,且所述流量调节元件43处于其初始的混合流动调节位置,从而使得在插入所述注射器通道33的注射器与插入所述小瓶转接器53的小瓶之间实现流体连接。所述稀释剂被注入所述小瓶,与小瓶内的内含物混合,然后抽吸所述液体药物入所述注射器,准备给药。
图5显示在将所述小瓶适配器53相对于所述壳体31旋转四分之一圈后的所述流体调节装置30,以便分开带有用完的小瓶的所述小瓶转接器53以及同时将所述流量调节元件43从其初始混合流动调节位置旋转至其随后的给药流量调节位置,从而实现在所述注射器通道33和所述药物给药通道34之间的流体连接。
图6至8显示适用于一注射器10和一小瓶16的液体药物输送装置70A。所述液体药物输送装置70A在结构上与所述流体调节装置30相似,因此它们的相似部分采用相同编号。所述液体药物输送装置70A与所述流体调节装置30的两个主要不同之处如下:所述装置70A包括一注射器通道71,所述注射器通道71被设计来实现与一注射器10而不是注射器28进行密封的流体连接,以及,第二,所述装置70A包括一具有一加宽端部接头73的药物给药通道72,所述加宽端部接头73可以与所述注射器10类似的方法防止具有母螺旋接头的常规针头在其上滑动安装。
所述注射器通道71包括一入口通道74(inletport),所述入口通道74被配置有一弹性管状密封元件76,所述弹性管状密封元件76由具有一自由端78的弹性管77构成。所述弹性管状密封元件76与所述纵轴32共轴。所述管77优选地由选自下列材料中的一种构成:PVC、硅酮、橡皮等。所述管77具有一内径D3和一超出其与所述入口通道74的连接点的任意长度L3,其中D3<D1、L3>L1,以在所述注射器的端部接头14被迫滑动插入其中时密封地接受。所述入口通道74支撑(supports)一用于预防疏忽引起的注射器脱离的自动的一次性使用锁紧机构79。所述锁紧机构79包括一与所述纵轴32共轴的坚固的管状导向元件81,所述管状导向元件81用于协助使用者沿着所述纵轴32调准所述注射器10以插入所述注射器通道,但是所述管状导向元件81具有一内径D4,所述内径D4稍大于D1,以使所述端部接头14可自由地通过所述管状导向元件81。所述导向元件81在内部具有会聚地朝向所述小瓶转接器通道36的四个等间距的弹性可变形的制动元件82,所述制动元件82末端具有停止在所述自由端78前从而具有一间距S1并且限定一具有较所述直径D1小的直径的孔的制动元件尖端82A,以使所述注射器的端部接头14在被迫滑动插入所述制动元件82时,可弹性地径向向外推动卡合在所述注射器的端部接头14后而环绕所述注射器端部13的所述制动元件82。所述后表面15抵着所述制动元件尖端82A停止,从而防止由于疏忽导致的注射器从所述液体药物输送装置70A上脱离。所述间距S1小于所述长度L1,以确保当所述后表面15在相对于所述装置70A的所述注射器10最后方的(most rearward)位置紧靠在所述制动元件尖端82A上时,所述端部接头14保持着所述管77内。
所述液体药物输送装置70A用于安全地核稳固地制备一带有重新溶解配制的液体药物以对患者即时给药的使用与所述流体调节装置30的使用相似。
所述液体药物输送装置70A的使用步骤如下:使用者将一小瓶与所述装置的小瓶适配器连接。使用者将一注射器沿着所述装置的纵轴对准,接着将所述注射器插入该装置的注射器通道。在延伸到所述弹性管的自由端前所述注射器的加宽端部接头径向向外推动所述制动元件,所述导向元件支撑着所述注射器。使用者继续滑动地插入所述注射器直到所述制动元件尖端卡住所述注射器的端部接头的后面,以将所述注射器固定在其中并防止注射器向外移动。所述注射器被充分地插入到所述弹性管的自由端以使使密封的流体连接稳固。使用者将所述注射器的稀释剂注射入所述小瓶内,然后摇动所述组合装置使重新溶解所述小瓶内的药剂。使用者倒置该组合装置并抽吸所述重新溶解的液体药物到所述注射器内。使用者将所述小瓶旋转四分之一圈以拆去小瓶。现在所述装置可准备给患者即时施用该重新溶解的液体药物。
图9至10显示一液体药物输送装置70B,除了所述弹性管状密封元件76是由一环状密封垫圈83而不是所述管77构成之外,所述液体药物输送装置70B与所述液体药物输送装置70A相似。所述密封垫圈83具有一外露的前表面83A和一轴向贯通的孔84,所述轴向贯通的孔84具有一内径D5,其中D5<D1。所述制动元件尖端82A停止在所述密封垫圈的前表面83A前从而具有一小于所述长度L1的间距,以便所述制动元件尖端82A连续地确实地将所述后表面15推向所述小瓶适配器通道36,从而在所述注射器10被迫滑动插入到所述注射器通道71内以实现密封流体连接时,所述端部接头14连续地轻度挤压所述密封垫圈83以实现密封流体连接。
图11至12显示了一液体药物输送装置70C,除了所述入口通道74包括一手动操作一次性使用锁紧机构86而不是所述自动一次性使用锁紧机构79之外,所述液体药物输送装置70C与所述液体药物输送装置70A相似。所述手动操作一次性使用锁紧机构86包括关键的安装的公锁紧元件87A和母锁紧元件87B,用于在施加一直接指向所述纵轴32的手动操作压力F时,卡合到一注射器端部接头14后面的注射器端部13上。
图13显示另一液体药物输送装置70D,其与所述液体药物输送装置70A相似,除了其入口通道74包括一修改过的自动一次性使用锁紧机构88,所述锁紧机构88包括一对开的环形管状导向元件89,所述对开的(split)环形管状导向元件89与所述纵轴32共轴,并包括弹性可变形地连接所述入口通道74的相对的导向元件单元89A和89B。所述导向元件89具有一大于所述直径D1的内径,以使得所述端部接头14可自由地通过它。所述导向元件89在内部具有一对会聚地朝向所述小瓶适配器通道36的相对的制动元件91,所述制动元件91末端具有停止在所述自由端78前并限定一具有较所述端部接头14的直径D1小的直径的孔的制动元件尖端91A,以使所述注射器的端部接头14在被迫插入所述制动元件91时,可弹性地向外推动卡合在所述注射器的端部接头14后而环绕所述注射器端部13的所述制动元件91。所述后表面15抵着所述制动元件尖端91A而停止,从而防止由于疏忽的注射器从所述液体药物输送装置70D上脱离。当所述后表面15在相对于所述装置70D的所述注射器10最后方的(most rearward)位置紧靠在所述制动元件尖端91A上时,所述端部接头14保持在所述管77内。
虽然本发明已描述了有关的有限数量的具体实施例,应了解的是对本发明所作的许多变化、调整和其他应用均是落在本发明所附的权利要求书的范围内。
Claims (7)
1.一种适用于具有一注射器端部的注射器和一带有橡皮塞的药用小瓶的液体药物输送装置,所述注射器端部的末端具有一加宽端部接头,所述加宽端部接头具有一外径D1和长度L1,所述装置包括:
(a)一壳体,所述壳体具有一纵轴、对应地用于接受所述注射器和施用所述液体药物的一注射器通道和一与所述纵轴同方向的药物给药通道,以及一位于所述注射器通道和所述药物给药通道中间的管状小瓶转接器通道;
(b)一流体调节元件,所述流体调节元件被支撑在所述小瓶转接器通道内,并可绕一通常垂直于所述纵轴的旋转轴旋转,所述流体调节元件包括一L型混合流动通道,所述L型混合流动通道包括一用于在混合流动调节位置与所述注射器通道流体连接的径向部分和一轴向部分,所述流体调节元件包括一用于在随后的给药流量调节位置实现所述注射器通道和所述药物给药通道之间的流体连接的末端为半圆形表面的给药流动通道,
(c)一用于伸缩地接受小瓶的小瓶适配器,包括一直立的管状公插头和一用于伸入到所述小瓶内并与所述插头是流体连接的向下的悬着的管状插管,
所述小瓶适配器初始被连接到所述壳体以将所述插头密封插入到所述轴向部分并被旋转与所述壳体分开,随后相对于所述壳体旋转所述小瓶转接器同时旋转所述流体调节元件从所述混合流动调节位置到所述给药流量调节位置,
其特征在于,
所述注射器通道包括一入口通道和一一次性使用的锁紧机构,所述入口通道具有一用于与所述注射器密封流体连接的弹性管状密封元件,所述一次性使用锁紧机构具有至少两个用于在所述注射器插入所述注射器通道时在所述注射器的端部接头后面散开从而预防由于疏忽导致的注射器从所述注射器通道上脱离的相对的制动元件,以及
所述药物给药通道具有一用于预防常规针头在所述加宽端部接头上滑动安装的加宽端部接头。
2.根据权利要求1所述的装置,其中,所述密封机构是由弹性管构成,所述弹性管具有一内径D3和一超出其与所述入口通道的连接点的任意长度L3,其中D3<D1、L3>L1,以在所述注射器被迫滑动插入所述注射器通道时密封地接受所述加宽端部接头。
3.根据权利要求1所述的装置,其中,所述密封机构时由一环状弹性垫圈构成,在所述注射器滑动插入所述注射器通道时被密封地压迫所述环状弹性垫圈。
4.根据权利要求1至3任一项所述的装置,其中,所述锁紧机构包括一与所述纵轴共轴的用于协助使用者沿着所述纵轴调准所述注射器以使所述注射器容易插入所述注射器通道的管状导向元件,
所述管状导向元件在内部具有会聚地朝向所述小瓶适配器通道并且终止在制动元件尖端部的至少两个相对的制动元件,所述制动元件尖端部停止在所述密封元件不远处并且限定一具有较所述直径D1小的直径的孔,以使所述注射器的加宽端部接头在被迫插入所述制动元件时可弹性地径向地向外推动所述至少两个制动元件。
5.根据权利要求4所述的装置,其中所述锁紧机构包括一具有至少两个弹性可变形的制动元件的固体管状导向元件。
6.根据权利要求4所述的装置,其中所述锁紧机构包括一可弹性、可变形地连接所述入口通道的对开的环形管状导向元件。
7.根据权利要求1至3任一项所述的装置,其中所述锁紧机构包括一用于在施加一直接指向所述纵轴的手动操作压力时卡合到一第二锁紧元件上以环绕所述注射器端部的第一锁紧元件。
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-
2007
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-
2008
- 2008-09-24 CN CN2008801082834A patent/CN101801329B/zh active Active
- 2008-09-24 ES ES08808079T patent/ES2370684T3/es active Active
- 2008-09-24 JP JP2010526421A patent/JP5680414B2/ja active Active
- 2008-09-24 DK DK08808079T patent/DK2180867T3/da active
- 2008-09-24 US US12/679,676 patent/US8016809B2/en active Active
- 2008-09-24 EP EP20080808079 patent/EP2180867B1/en not_active Not-in-force
- 2008-09-24 AT AT08808079T patent/ATE525055T1/de not_active IP Right Cessation
- 2008-09-24 WO PCT/IL2008/001278 patent/WO2009040804A2/en active Application Filing
- 2008-09-24 BR BRPI0817989A patent/BRPI0817989A2/pt not_active Application Discontinuation
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Also Published As
Publication number | Publication date |
---|---|
JP2010540066A (ja) | 2010-12-24 |
IL186290A0 (en) | 2008-01-20 |
JP5680414B2 (ja) | 2015-03-04 |
US8016809B2 (en) | 2011-09-13 |
WO2009040804A2 (en) | 2009-04-02 |
WO2009040804A3 (en) | 2009-05-14 |
EP2180867A2 (en) | 2010-05-05 |
ES2370684T3 (es) | 2011-12-21 |
CN101801329B (zh) | 2012-11-07 |
DK2180867T3 (da) | 2012-01-16 |
EP2180867B1 (en) | 2011-09-21 |
US20100198148A1 (en) | 2010-08-05 |
BRPI0817989A2 (pt) | 2015-09-15 |
ATE525055T1 (de) | 2011-10-15 |
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