CN113490477B - 移液装置 - Google Patents
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Abstract
描述了一种移液装置。所述装置包括：连接器主体，所述连接器主体包括限定突片的突出部分；以及IV端口，所述IV端口布置在所述连接器主体的第一端部处，所述IV端口包括从中突出并限定切口的细长的连接构件。所述突出部分被构造为由所述细长的连接构件接纳，并且所述突片被构造为与所述切口配合，以便相对于所述连接器主体可旋转地固定所述IV端口。
Description
发明背景
本发明涉及移液装置。
容纳要递送给患者的输注液的常规的输液容器一般采用输液袋、输液瓶等形式。一般利用预填充注射器或小瓶经由移液装置将液体药物添加到输液内容物，以形成含药输注液。然后，一般将包括IV刺针的输液器插入到移液装置的IV端口中，以用于向患者输注含药输液内容物。
典型地，IV端口经由粘合剂连接到移液装置的其余部分。必须移除覆盖的扭断构件才能接取IV端口，移除要求施加扭矩。使用者抓握移液装置以移除该扭断构件的方式可能会造成粘合剂暴露于扭矩。粘合剂的损坏会使移液装置受损。
因此，制造在IV端口与移液装置的其余部分之间具有被设计成承受这种扭矩而不对其造成损坏的可旋转地固定的机械连接的移液装置将是有利的。
附图说明
在结合附图阅读时将更好地理解以下对本发明的实施例的描述。然而，应当理解，本发明不限于所示的精确布置和手段。在附图中：
图1A是可与根据本发明的移液装置一起使用的输液袋的前正视图；
图1B是可与根据本发明的移液装置一起使用的IV瓶的前正视图；
图1C是可与根据本发明的移液装置一起使用的预填充无针注射器、公小瓶适配器和小瓶的前正视图；
图1D是可与根据本发明的移液装置一起使用的输液器的前正视图；
图2A是根据本发明的移液装置的第一构型的透视图；
图2B是沿着图2A的剖面线2b-2b截取的图2A的移液装置的横截面正视图；
图2C是沿着图2A的剖面线2c-2c截取的图2A的移液装置的横截面正视图；
图2D是图2A的移液装置的分解透视图；
图3A是根据本发明的移液装置的第二构型的局部前正视图；
图3B是沿着图3A的剖面线3-3截取的图3A的移液装置的自密封入口阀在其关闭位置的放大横截面正视图；
图3C是沿着图3A的剖面线3-3截取的自密封入口阀在其打开位置的放大横截面正视图；
图3D是自密封入口阀的顶平面图；并且
图4是沿着诸如图2A的线2b-2b的剖面线截取的根据本发明的移液装置的第三构型的局部横截面正视图。
具体实施方式
在以下描述中，仅为了方便而不是为了限制来使用某些术语。字词“下部”、“底部”、“上部”和“顶部”标示在所参考的附图中的方向。根据本公开，字词“向内”、“向外”、“向上”和“向下”是指分别朝向和远离移液装置及其标示部分的几何中心的方向。除非在本文中明确地阐述，否则术语“一个(a/an)”和“所述”不限于一个要素，而是应当被解读为意指“至少一个”。术语包括以上指出的字词、其衍生词，以及具有类似含义的字词。
还应理解，本文中在参考本发明的部件的尺寸或特性时使用的术语“约”、“近似”、“大体上”和“基本上”等术语指示所描述的尺寸/特性并不是严格边界或参数，并且不排除其功能上类似的微小变化。至少，包括数值参数的此类参考将包括使用本领域中接受的数学和工业原理(例如，舍入、测量结果或其他系统误差、制造公差等)的变化，这些变化将不使最低有效位变化。
详细地参考附图，其中相同的数字始终指示相同的要素，图2A-图4中示出了移液装置50、50'、50”的多种构型，其旨在与容纳输注液的输液容器和与附加剂转移装置一起使用。这种输液容器可采用输液袋10(图1A)、输液瓶18(图1B)等形式，并且这种附加剂转移装置可采用具有公连接器26(例如，公鲁尔连接器)的注射器24(图1C)、可连接到小瓶适配器30或62(如以下将进一步解释)的密封小瓶28(图1C)等形式。
如本领域普通技术人员所应当理解，常规的输液袋10(图1A)包括容纳输注液的储液器12，其与静脉注射(IV)或给药端口14和附加剂端口16。输液袋10在从中施用输注液时可塌缩。常规的输液瓶18(图1B)也包括容纳输注液的储液器20，并且由塞22密封地封闭(以本领域普通技术人员所熟知的方式)。输液瓶18可由旨在在从中施用输注液时塌缩的可塌缩材料构成，或者替代地，由不可塌缩材料构成，例如聚合物或塑料材料(下文称为“塑料”)、玻璃等。
注射器24一般预填充有药剂液体，该药剂液体用于注射到输液袋10或瓶18中，以与在其中的输注液混合来形成含药输注液，以用于向患者给药或直接地向患者给药。类似地，小瓶28一般容纳在给药之前要求重构的药剂液体附加剂或冻干粉药物。小瓶28的内容物被引入到输液袋10或瓶18中，以与输注液混合来形成含药输注液以用于向患者给药(如以下将进一步详细地描述)。
转向图2A-图4，移液装置50、50'、50”包括三叉式连接器主体52。三叉式连接器主体52在其第一端部处包括IV端口54(图2A-图4)。在一种构型中，如图2A-图2D所示，三叉式连接器主体52包括在其第二端部处的小瓶适配器56。替代地，在另一种构型中，如图3A和图4所示，三叉式连接器主体52可在其第二端部处包括IV刺针58。在一种构型中，如图2A、图2B、图2D和图3A-图3D所示，三叉式连接器主体52还在其第三端部处包括常闭(NC)无针附加剂端口60。替代地，在另一种构型中，如图4所示，三叉式连接器主体52可包括在其第三端部处的小瓶适配器162。即，在示例性构型中，移液装置50可包括在其第一端部处的IV端口54、在其第二端部处的小瓶适配器56或IV刺针58、和在其第三端部处的无针附加剂端口60或小瓶适配器162，但是本公开不限于此。
转向图2A-图2D，三叉式连接器主体52可包括在其第二端部处的小瓶适配器56，以用于将移液装置50与输液瓶18一起使用。小瓶适配器56由合适的刚性塑料材料构成，诸如例如聚碳酸酯等。小瓶适配器56包括在连接器主体52的第二端部处的横向地延伸的顶表面64和从顶表面64向下地悬垂的裙部66，其被构造为(例如，大小和尺寸设定为)用于可伸缩地卡扣配合安装到IV瓶18上(以本领域普通技术人员所熟知的方式)。穿刺套管68(具有在其刺针端部附近具有在周边设置的孔隙69a的液体内腔69)从横向小瓶适配器顶表面64向下地突出，以用于在将小瓶适配器56可伸缩地卡扣配合安装在IV瓶18上时刺穿IV瓶塞22。小瓶适配器裙部66包括至少两个向内地定向的突起70(图2C)，以用于卡扣配合在IV瓶18的处于塞22下方的凸缘21下方。在一个实施例中，穿刺套管68可具有约3mm的外径。
连接器主体52限定内腔72，该内腔与小瓶适配器56的穿刺套管68的内腔69连续流体连通，并且在与穿刺套管68相反的方向上从小瓶适配器56的顶表面64突出。内腔72分叉为第一内腔72a(在短节部分88内)，以及第二内腔72b。在所示的实施例中，第一内腔72a与内腔69同向，但是本公开不限于此。第二内腔72b相对于第一内腔72a和内腔69成角度，即，从第一内腔72a和内腔69分支。如图2B、2C所示，第一内腔72a可包括直列式微粒过滤器73，以防止固体颗粒在内腔69与内腔72a、72b之间传递。
如图3A和图4所示，移液装置50'、50”的三叉式连接器主体52的另一种构型包括在其第二端部处的IV刺针58，以用于将移液装置50与输液袋10一起使用，即，用于将IV刺针58密封地插入到袋10的IV端口14中。IV刺针58也由合适的刚性塑料材料构成，诸如例如聚碳酸酯等。IV刺针58包括在其刺针端部附近具有在周边设置的孔隙58b的内部液体内腔58a(与内腔72a同向并且与内腔72a、72b连续流体连通)。凸缘74在其相对端部附近从IV刺针58侧向地延伸，以用于限制插入到袋10的IV端口14中的插入深度。在一个实施例中，IV刺针58与凸缘74一体地形成为注塑成型整体结构，但是本公开不限于此。当不使用时，刺针帽盖75(图4)可可移除地覆盖刺针58。
如图2A-图3D所示，三叉式连接器主体52可包括一体地形成在其第三端部处的无针附加剂端口60，以用于将移液装置50与具有公连接器的任何附加剂转移装置(例如，注射器24或安装到小瓶适配器30的小瓶28)一起使用。无针附加剂端口60定位在第二内腔72b的周边端部处，并且装配有自密封入口阀76以用于螺纹地接纳公连接器。入口阀76典型地由刚性透明塑料材料构成，诸如例如聚碳酸酯等。入口阀76具有阶梯状外表面77，包括邻接表面78和边缘79。入口阀76容纳具有管状主要部分81和圆柱形无针进入部分82的硅树脂自密封阀构件80(图3B、图3C)。无针进入部分82具有暴露的进入表面83和沿着其延伸的预成型狭缝83a(图3B-图3D)。自密封阀构件80具有固有长度L1，并且尺寸设定为使得进入表面83与边缘79齐平，从而使得入口表面83能够出于消毒目的被容易地擦拭(参见图3B)。
如图3B和图3C最佳地示出的，公连接器、例如注射器24的公鲁尔连接器26可螺纹地连接到有针附加剂端口60上，并且被推进直到连接器26抵靠邻接表面78。在推进期间，公鲁尔连接器26将阀构件80压缩至压缩长度L2＜L1，这使进入表面83沿着其预成型狭缝83a分开，以使得在注射器24与内腔72b之间能够流体连通(参见图3C))。如本领域普通技术人员所应当理解，注射器24可预填充有液体附加剂。替代地，注射器24可填充有由冻干粉药物小瓶重构的液体药物。所重构的液体药物可能已经用从输液袋10、输液瓶18等抽吸的液体内容物重构。还应理解，小瓶适配器30的公鲁尔连接器30a可以相同的方式螺纹地连接到无针附加剂端口60上。小瓶适配器30以本领域普通技术人员所熟知的方式可伸缩地卡扣配合安装到小瓶28上，以使得装置50能够与呈小瓶28的形式的附加剂转移装置一起使用。小瓶28可容纳在向患者施用输注液之前可与输注液混合或在输注过程期间向患者施用的液体附加剂。在小瓶28容纳冻干粉药物的情况下，可通过挤压输液袋10或输液瓶18以迫使液体从输液袋10或瓶18进入小瓶28中来重构药物。因此，如本领域普通技术人员所应当理解，在将移液装置50联接在输液袋10或输液瓶18上(如前所述)，并且将移液装置50与注射器24或小瓶28联接(如前所述)时，输液袋10或输液瓶18内的内容物经由连接器主体52的流体连接的内腔72a、72b与注射器24或小瓶28内的内容物流体连接并可混合/组合。
替代地，移液装置50可专用于与呈小瓶28的形式的附加剂转移装置一起使用。即，在替代构型中，并且如图4所示，移液装置50”的小瓶适配器162可一体地形成在三叉式连接器主体52的第三端部处。一体式小瓶适配器162包括用于可伸缩地卡扣配合安装到小瓶28上的裙部162a(以标准的方式)、和用于例如经由其塞刺穿小瓶28来与其流体连通的套管162b。穿刺套管162b包括与第二内腔72b并进而与第一内腔72a流体连通的内腔162c。添加/混合小瓶28内的内容物可如前所述那样执行。
不管移液装置50相对于三叉式连接器主体52的第二端部或第三端部的构型如何，主体52都在其第一端部处包括IV端口54。如图2A-图2D所示，IV端口54包括靠近端口54的周边自由端部的扭断构件54a、和从中突出的细长的连接构件86，该细长的连接构件具有从中延伸穿过并终止于敞开端部86a(与扭断构件54a相对)的内部内腔54b。组装好的移液装置50的内部内腔54b与三叉式连接器主体52的第一内腔72a同向地延伸。在一个实施例中，IV端口54可由合适的柔性塑料材料构成，诸如例如PVC等。
IV端口54包括密封膜84，该密封膜大体上横向地定位在细长的连接构件86内(参见图2B、图2C)，延伸穿过内部内腔54b。因此，可移除扭断构件54a而不导致超出密封膜84的流动连通。仅在刺穿密封膜84时才实现超出密封膜84的流动连通(如以下进一步详细地讨论)。因此，扭断构件54a保持密封膜84无菌，直至其被使用。
如在图2A-图2D中最佳地示出的，连接器主体52包括从横向小瓶适配器顶表面64(或从IV刺针58(未示出))向上地突出、即远离小瓶适配器56或IV刺针58并限定在其中的第一内腔72a的短节部分88。短节部分88终止于具有敞开端部90a的带倒钩的装配构件90中，使得第一内腔72a(以及因此第二内腔72b)与细长的连接构件86的内部内腔54b流体连通。带倒钩的装配构件90相对于细长的连接构件86的内径和材料来构造(即，设定大小、尺寸、材料)，以通过敞开端部86a推进到内部内腔54b中，并且在两者间形成带倒钩的、摩擦(即，干涉)配合。如本领域普通技术人员所应当理解，带倒钩的装配构件90准许其推进到内部内腔54b中，以将IV端口54同向地密封地且牢固地安装在连接器主体52的短节部分88上，并且还在不损坏细长的连接构件86和带倒钩的装配构件90中的至少一者的情况下基本上防止短节部分88抽回。
换言之，如图所示，带倒钩的装配构件90为截锥形的，沿着远离敞开端部90a的方向具有逐渐地增大的直径。带倒钩的装配构件90的相对端部从下面的短节部分88限定了更大的直径，从而在试图将带倒钩的装配构件90从细长的连接构件86抽出时，产生咬入到细长的连接构件86的内部侧壁的环形肋92。因此，带倒钩的装配构件90在组装期间可推进到细长的连接构件86的内部内腔54b中，并且之后，不太容易能够在不造成损坏的情况下被抽出。
如在图2D中最佳地示出的，细长的连接构件86的限定其敞开端部86a的边缘包括至少一个切口94a，并且短节部分88包括被构造成与该切口配合的对应的至少一个径向突片94b。在所示的实施例中，细长的连接构件86包括成角度地间隔开的多个切口94a，并且短节部分88包括对应的成角度地间隔开的多个突片94b。在将IV端口54安装在连接器主体52的带倒钩的装配构件90上期间，突片94b与切口94a配合，以相对于移液装置50的其余部分可旋转地固定IV端口54。因此，有利地，IV端口54以机械的方式与连接器主体52密封地组装，以及以机械的方式充分地与连接器主体52可旋转地固定，从而最小化在扭断扭断构件54a时施加扭矩期间对在两者间的连接的损坏。
在使用中，在将移液装置50连接在输液袋10或输液瓶18上(如前所述)，将移液装置50与注射器24或小瓶28联接(如前所述)，并且将液体袋10或输液瓶18内的内容物与注射器24或小瓶28内的内容物混合和/或向其添加(以产生含药输注液)之后，移除扭断构件54a，从而提供接取内部内腔54b的通路。然后，输液器95(图1D)的IV刺针96密封地插入到内部内腔54b中并刺穿密封膜84，从而超出该密封膜将IV刺针96与内部内腔54b的任何其余部分以及进而第一内腔72a和第二内腔72b流体连接84，以用于向患者施用含药输注液。常规地，输液器95附加地包括第一管件97a、夹具97b、滴注器97c、第二管件97d、辊夹97e和公鲁尔连接器97f以用于控制对患者的流体给药。
如在图2D中最佳地示出的，切口94a中的每者可等距地径向地间隔开。同样，突片94b中的每者可等距地径向地间隔开。然而，可设想用于切口94a和突片94b的其他间距。另外，突片94b中的每者可具有矩形横截面，并且切口94a可限定与突片94b互补的形状。然而，可设想切口94a和突片94b的其他形状。
本领域技术人员将了解，在不脱离上述实施例的广泛的发明构思的情况下，可对上述实施例做出改变。作为一个非限制性示例，无针附加剂端口60可由手动地操作的旋塞等代替。因此，应当理解，本发明不限于所公开的特定实施例，而是旨在涵盖在本发明的精神和范围内的修改。
Claims (13)
1.一种移液装置，包括：
连接器主体，所述连接器主体包括限定突片的突出部分；以及
IV端口，所述IV端口包括细长的连接构件和扭断构件，所述IV端口布置在所述连接器主体的第一端部处，所述细长的连接构件从所述IV端口中突出并限定切口，并且所述扭断构件被布置成在通过施加扭矩而被移除时提供进入所述IV端口的通路，
其中所述突出部分被构造为由所述细长的连接构件接纳，并且所述突片被构造为与所述切口配合，以便相对于所述连接器主体可旋转地固定所述IV端口。
2.如权利要求1所述的移液装置，其中所述切口包括成角度地间隔开的多个切口，并且所述突片包括对应的成角度地间隔开的多个突片。
3.如权利要求2所述的移液装置，其中所述突片中的每者具有基本上矩形的横截面。
4.如权利要求2或权利要求3所述的移液装置，其中所述突出部分包括用于将所述IV端口密封地安装到所述突出部分的装配构件。
5.如权利要求4所述的移液装置，其中所述装配构件包括敞开端部，并且被成形为截锥形的，沿着远离所述敞开端部的方向具有逐渐增大的直径。
6.如权利要求1或2所述的移液装置，包括：
小瓶适配器，所述小瓶适配器被构造为安装在IV瓶上，并且布置在所述连接器主体的第二端部处；以及
附加剂端口，所述附加剂端口布置在所述连接器主体的第三端部处；
其中所述连接器主体提供在所述IV端口、所述小瓶适配器和所述附加剂端口之间的流体连通。
7.如权利要求6所述的移液装置，其中所述小瓶适配器包括用于刺穿IV瓶塞的穿刺套管。
8.如权利要求6所述的移液装置，其中所述连接器主体限定与所述小瓶适配器的穿刺套管的内腔连续流体连通的内腔，其中所述内腔分叉为在所述突出部分内的第一内腔、以及第二内腔，所述附加剂端口定位在所述第二内腔的周边端部处。
9.如权利要求1或2所述的移液装置，其进一步包括：
IV刺针，所述IV刺针布置在所述连接器主体的第二端部处；以及
附加剂端口，所述附加剂端口布置在所述连接器主体的第三端部处，
其中所述连接器主体提供在所述IV端口、所述IV刺针和所述附加剂端口之间的流体连通。
10.如权利要求9所述的移液装置，其中所述连接器主体限定与所述IV刺针的穿刺套管的内腔连续流体连通的内腔，其中所述内腔分叉为在所述突出部分内的第一内腔、以及第二内腔，所述附加剂端口定位在所述第二内腔的周边端部处。
11.如权利要求6所述的移液装置，其中所述附加剂端口包括自密封阀。
12.如权利要求1所述的移液装置，其中所述扭断构件包括可断裂区段，所述可断裂区段被构造为在向第一扭断构件施加扭矩时断裂。
13.如权利要求1或2所述的移液装置，其中所述连接器主体是三叉式连接器主体。
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| PCT/IB2020/050790 WO2020157719A1 (en) | 2019-01-31 | 2020-01-31 | Liquid transfer device |
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- 2020-01-31 US US17/427,155 patent/US11918542B2/en active Active
- 2020-01-31 IL IL285038A patent/IL285038B/en unknown
- 2020-01-31 JP JP2021544627A patent/JP7101900B2/ja active Active
- 2020-01-31 EP EP20704599.8A patent/EP3917486B1/en active Active
- 2020-01-31 PT PT207045998T patent/PT3917486T/pt unknown
- 2020-01-31 ES ES20704599T patent/ES2946032T3/es active Active
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| EP3917486A1 (en) | 2021-12-08 |
| PT3917486T (pt) | 2023-05-08 |
| ES2946032T3 (es) | 2023-07-12 |
| IL285038B (en) | 2022-09-01 |
| IL285038A (en) | 2021-09-30 |
| JP7101900B2 (ja) | 2022-07-15 |
| CN113490477A (zh) | 2021-10-08 |
| JP2022508665A (ja) | 2022-01-19 |
| WO2020157719A1 (en) | 2020-08-06 |
| EP3917486B1 (en) | 2023-03-08 |
| US20220125680A1 (en) | 2022-04-28 |
| US11918542B2 (en) | 2024-03-05 |
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