CN102985047B - 带密封结构的流体转移装置 - Google Patents
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61J—CONTAINERS SPECIALLY ADAPTED FOR MEDICAL OR PHARMACEUTICAL PURPOSES; DEVICES OR METHODS SPECIALLY ADAPTED FOR BRINGING PHARMACEUTICAL PRODUCTS INTO PARTICULAR PHYSICAL OR ADMINISTERING FORMS; DEVICES FOR ADMINISTERING FOOD OR MEDICINES ORALLY; BABY COMFORTERS; DEVICES FOR RECEIVING SPITTLE
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61J—CONTAINERS SPECIALLY ADAPTED FOR MEDICAL OR PHARMACEUTICAL PURPOSES; DEVICES OR METHODS SPECIALLY ADAPTED FOR BRINGING PHARMACEUTICAL PRODUCTS INTO PARTICULAR PHYSICAL OR ADMINISTERING FORMS; DEVICES FOR ADMINISTERING FOOD OR MEDICINES ORALLY; BABY COMFORTERS; DEVICES FOR RECEIVING SPITTLE
- A61J1/00—Containers specially adapted for medical or pharmaceutical purposes
- A61J1/14—Details; Accessories therefor
- A61J1/20—Arrangements for transferring or mixing fluids, e.g. from vial to syringe
- A61J1/2003—Accessories used in combination with means for transfer or mixing of fluids, e.g. for activating fluid flow, separating fluids, filtering fluid or venting
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Abstract
本发明的目的在于流体转移装置,它包括一个具有顶壁和带插管尖的插管的小瓶衔接器,以及像弹性O型圈那样的密封元件,密封元件密封地围绕着插管且初始时布置成朝着插管尖并留出一段距离离开顶壁,当插管尖在穿刺点接触到小瓶塞后封闭元件初次接触小瓶塞,随后,在将小瓶衔接器锁扣式密接安装到小瓶上去的过程中,密封元件被滑动推向顶壁并继续将穿刺点封闭住。
Description
技术领域
本发明涉及供药用容器应用的流体转移装置,该容器利用有弹性的瓶塞进行气密封,容器装有液体或者粉末的药剂。
背景技术
用于在前述的药用容器或者小瓶上锁扣式密接的流体转移装置现普遍用于液体药物的重构和治疗目的,该装置包括带有尖的插管的小瓶衔接器。这样的装置尤其包括小瓶内衔接器,小瓶外衔接器,申请者的流体转移装置,申请者的流体转移总成等。在流体转移装置锁扣式密接到小瓶塞上的过程中,小瓶塞上会产生裂缝,导致将液体内容物注射到小瓶中或者从小瓶中吸出来时液体的泄露。裂缝还给在流体转移总成,例如前述的流体转移总成中的液体药物重构造成麻烦,它是借助于装有粉末的小瓶的负压来操作的。
裂缝的产生往往起因于流体转移装置和小瓶最初没对准,因为当小瓶与流体转移装置锁扣式密接时小瓶要对准流体转移装置的中心,这样,流体转移装置就同轴地与小瓶锁扣式密接。最初没对准的形式可能是流体转移装置与小瓶之间对歪斜了或者是偏心了,尤其是小瓶衔接器带有能辅助小瓶衔接器引向小瓶的喇叭口外撑裙时。但即使流体转移装置和小瓶最初对准了,由于有弹性的瓶塞的结构,裂缝还是会产生。
题为”流体转移装置”的美国专利公开US Publication No.2004/0236305图解和描述了一种装在药用容器上的流体转移装置。该流体转移装置包括一个接收盖和一根刺穿弹性瓶塞的穿孔心棒。对应着它的穿孔方向,该穿孔心棒有前穿孔部分和直径大些以封闭瓶塞裂缝的后密封部分。另外一个实施例包括设置有带固定住的弹性O形圈的后密封部分以增加密封能力。
题为”用于接种插孔的通用配件”的美国专利US Patent No.5,374,264图解和描述了一种装在药用容器上的流体转移装置。该流体转移装置包括一个小瓶衔接器,小瓶衔接器具有顶壁,外撑裙和尖的插管,并带一个外罩,当受到顶壁与药用容器的弹性瓶塞之间的挤压时会像手风琴那样地折叠起来。
发明详述
本发明以防止装有药剂的药用容器或者小瓶泄露的带密封结构的流体转移装置为目标。该流体转移装置包括一个小瓶衔接器,小瓶衔接器有顶壁,带有拐折部分的朝下垂悬的外撑裙,用以与带小瓶塞的小瓶锁扣式密接,尖的管式插管,用来将小瓶衔接器与小瓶锁扣式密接时刺穿该小瓶塞,以及一个流体通道与该插管保持流体连通,使外部与小瓶内部流体连通。该小瓶衔接器可以带有通常圆柱形的裙围或者是所谓的带喇叭口的外撑裙以辅助导引向小瓶。
每个流体转移装置都包括一个沿着插管布置的并且密封地围绕着插管的像弹性O形圈那样的密封元件。密封元件是用来当它接触到小瓶塞时将围绕着其插管穿刺点密接的周围密封开来,并且当流体转移装置锁扣式密接到小瓶上时,它被沿着插管滑动推向顶壁以保持与穿刺点的连续封闭(密封),由此封住任何因锁扣式密接安装产生的裂缝而不管裂缝形成的原因。当流体转移装置完整地锁扣式密接安装在小瓶上,该密封元件典型地在流体转移装置的顶壁和小瓶塞之间受到轴向的挤压,于是,该密封元件径向地朝外伸长以覆盖最上面的瓶塞表面的较大的面积。
密封元件沿着插管的最初位置取决于它是要用来防止负压泄露还是液体泄露。在前一种情形下,密封元件必须沿着插管靠近它的插管尖布置,这样,在小瓶塞穿孔之前它就接触到了小瓶塞。而在后一种情形下,密封元件可以布置得离开插管尖远一些。带有大小尺寸按比例的密封元件的流体转移装置可以被设计成用于不同标准大小的瓶子,例如,13mm,20mm,和更大的瓶子。本发明可以容易地被用于常规的流体转移装置,包括带尖的插管的小瓶衔接器。
附图的简要说明
为了理解本发明并且看到它如何付之实现,只是通过不限定的实例并参考附图来说明优选的实施例,附图中相同的部件标号相同:
图1显示了注射器,带小瓶塞的小瓶,和常规小瓶衔接器的示意图;
图2为图1中小瓶衔接器的底视图;
图3A至图3E显示了将图1中的小瓶衔接器锁扣式密接安装在小瓶上的过程,以及由于该小瓶衔接器与小瓶一开始对偏心了在小瓶塞上形成裂缝的过程;
图4为小瓶衔接器的正面图,它包括依照本发明的密封元件;
图5为图4中小瓶衔接器的底视图;
图6为图4中小瓶衔接器的A-A轴向截面图,显示出其密封元件的初始位置;
图7为图4中小瓶衔接器的密封元件的特写透视图;
图8A至图8E显示了将图4中的小瓶衔接器锁扣式密接安装在小瓶上的过程,其密封元件将裂缝都密封开来;
图9描画了申请者的流体转移装置的示意图,它包括锁扣式密接安装在小瓶上的小瓶衔接器;和
图10为申请者的流体转移总成的轴向截面图,它包括一个小瓶外衔接器,一个小瓶内衔接器,每个都装有一个密封元件。
本发明优选实施例的详细说明
图1显示了构成生理液来源的注射器10,构成药用容器的小瓶20以及由用于注射器10和小瓶20的小瓶内衔接器构成的流体转移装置30,这些都是本领域所熟知的。注射器10包括带有活塞12和鲁尔锁外(阳)连接器(male Luer lockconnector)13的空筒11。注射器10可以利用其它类型的外连接器来构成。小瓶20在长度方向上的小瓶轴为20A,并包括带有小瓶缘22的小瓶身21和介于小瓶身21和小瓶缘22之间的细径颈23。小瓶缘22限定了利用弹性小瓶塞26气密封的小瓶开口24,开口被金属带27盖住。小瓶塞26贴近小瓶轴20A的瓶塞厚度为T。小瓶身21限定了小瓶内部28,它包含粉末的或者液体的内容物29。小瓶塞26最上面的瓶塞表面为26A。典型地,注射器10装有稀释剂来重构小瓶中的内容物29。
流体转移装置30由小瓶内(阴)衔接器31构成,它的长度方向上的衔接器轴为31A,并包括顶壁32,带有用于与小瓶20锁扣式密接的多个拐折部分34的朝下垂悬的喇叭口外撑裙结构33,带有刺穿小瓶塞26的插管尖37的尖的管式插管36,以及与插管36流体连通的一个流体通道腔38。小瓶内衔接器31包括一个与鲁尔锁内连接器39端接的流体通道腔38,用以注射器10封闭螺纹安装在其上。拐折部分34具有贴近顶壁32的第一部分34A,它包括一个用以在小瓶缘22下面的锁扣式密接的向内指向的突起41和在顶壁32的远端的第二部分34B。相对于第一部分34A,第二部分34B对向一个外部钝角。喇叭口外撑裙33有助于将流体转移装置30装在小瓶20上,但是与通常圆柱形的裙围相比,可能导致较大的偏心不同轴。
图3A至图3E显示了以水平面S作为参照的将流体转移装置30锁扣式密接安装到小瓶20上的过程,以及在小瓶塞26上产生裂缝(刺穿)的过程。
图3A显示了将流体转移装置30锁扣式密接安装到小瓶20上的第一步,开始时的最初偏心不同轴现象由小瓶轴20A与衔接器轴31A之间的最初不同轴距离MD1所表示。在穿刺点PS处插管尖37接触到小瓶塞26。
图3B显示了将流体转移装置30锁扣式密接安装到小瓶20上的第二步。箭头A指出了小瓶衔接器31对于小瓶20的挤压,它造成其插管尖37开始在穿刺点PS刺穿小瓶塞26,最左边的拐折部分34稍微向外挠曲。不同轴距离MD维持不变。
图3C显示了将流体转移装置30锁扣式密接安装到小瓶20上的第三步。箭头B表示了流体转移装置30对于小瓶20进一步的挤压,它造成外撑裙33将流体转移装置30对准小瓶20以减少不同轴距离至较短的距离MD2,其中MD2<MD1。这样的对准把插管36朝小瓶轴20A推动,接着,它造成插管尖37在最上面的瓶塞表面26A上开始裂缝42。
图3D显示了将流体转移装置30锁扣式密接安装到小瓶20上的第四步,其中,流体转移装置30完全与小瓶20同轴,插管尖37已经完全穿透了小瓶塞26,在流体转移装置30锁扣式密接到小瓶20上之前建立起与小瓶内部28的流体连通。裂缝42可能会扩展穿过小瓶塞26,因而形成一个泄露的途径。最终的不同轴距离MD为零。
图3E显示了将流体转移装置30锁扣式密接安装到小瓶20上的最后一步,其中,拐折部分34锁扣式密接到小瓶缘22上。
图4至图7显示了由小瓶内衔接器31构成的流体转移装置50,所以采用了相同的编号。流体转移装置50还包括了一个像弹性O形圈那样的密封元件51。密封元件51由较软的弹性材料制成,例如硅,或者其它的比小瓶塞26要软得多的弹性材料。通常O形圈的肖氏A级(Shore A)硬度等级为60-90,肖氏A级硬度70为标准。密封元件51由较软的弹性材料制成,优选肖氏A级硬度低于50,范围在5-35之间。手动地在密封元件51上施加一个轴向的压力F使得该密封元件在与轴向压力F横向的径向方向E上朝外扩张,呈现出扁平的圆环形状(见图8E)。
密封元件51具有管式主体52和渐缩形的管式导向段53,它具有导向表面54。密封元件51可滑动地装配在插管36上,并沿着插管36、朝着顶壁32、离开插管尖37布置,使得导向表面54与插管尖37之间留有暴露的插管长度L。暴露的插管长度L小于瓶塞厚度T,这样,在插管36刺穿了小瓶塞26之前,密封元件51就接触到了小瓶塞26。密封元件51紧密地围绕着插管36形成气密封,与朝着顶壁转动(在肖氏A级硬度较硬时会发生)相反,在将密封元件51滑动推向顶壁32时,气密封得以连续地维持。
图8A至图8E显示了如图3A至图3E所示的将流体转移装置50锁扣式密接安装到小瓶20上来密封裂缝42的同样步骤。图8A显示出插管尖37在穿刺点接触到了瓶塞表面26A,密封元件51一开始被布置在瓶塞表面26A的上方。图8B显示了当插管尖37从穿刺点PS开始来刺破小瓶塞26时,密封元件51接近瓶塞表面26A。图8C显示了流体转移装置50开始锁扣式密接到小瓶20上,密封装置51封住了穿刺点PS,因而密封了裂缝42。图8D显示了当流体转移装置50被进一步压到小瓶20上时,密封元件51正被滑动推向顶壁32。密封元件51继续维持围绕着插管36的密封,封住了穿刺点PS。图8E显示了在流体转移装置50完全锁扣式密接安装在小瓶20上时,密封元件51在顶壁32与瓶塞表面26A之间轴向地受到挤压。密封元件51变形成为受挤压的圆环形状,并继续将裂缝密封。
图9显示了流体转移控制装置60的示意图,它包括锁扣式密接在小瓶20上的小瓶衔接器61。该小瓶衔接器61可以装有密封元件51。图10显示了流体转移总成70的轴向截面图,它包括一个小瓶外衔接器71以及一个与小瓶内衔接器31类似的小瓶内衔接器72。小瓶衔接器71和72可以各自装有密封元件51。
尽管已经根据有限数量的实施例描述了本发明,应该理解到,在所附权利要求的范围内可以对本发明进行许多改变,修饰和其他的应用。
Claims (5)
1.供药用小瓶应用的流体转移装置,药用小瓶具有长度方向上的小瓶轴,且包括有储存药剂的小瓶内部的小瓶身,限定小瓶开口的小瓶缘,介于小瓶身和小瓶缘之间的细颈,封住小瓶开口的小瓶塞,靠近小瓶轴的小瓶塞厚度为T,小瓶塞有最上面的瓶塞表面,该流体转移装置包含:
a)小瓶衔接器,它具有长度方向上的衔接器轴,并包括与所述衔接器轴横向的顶壁,用以锁扣式密接在小瓶缘上来将所述的小瓶衔接器同轴安装在小瓶上的具有带拐折部分的朝下垂悬的外撑裙,用以在锁扣式密接安装时、穿刺点最初接触小瓶塞以及穿透小瓶塞以形成与小瓶内部的流体连通的尖的管式插管,以及与所述插管流体连通的流体通道腔;和
b)像弹性O形圈那样的密封元件紧密地环绕着所述插管,所述密封元件一开始时沿着所述插管布置并且离开所述顶壁和插管尖,使所述密封元件与所述插管尖之间留有暴露的插管长度L,在所述插管尖在所述穿刺点接触到小瓶塞之后所述密封元件起始与小瓶塞接触,随后,所述密封元件被滑动推向所述顶壁并且在将所述小瓶衔接器锁扣式密接安装到小瓶上的过程中继续封住所述的穿刺点;
其中,所述密封元件在所述顶壁与瓶塞最上面的表面之间受到轴向挤压时在径向上发生变形。
2.根据权利要求1所述的装置,其特征在于,所述密封元件包括管式主体和面朝所述插管尖的渐缩形的管式导向段。
3.根据权利要求1或者2所述的装置,其特征在于,所述暴露的插管长度L比所述瓶塞厚度T短,这样使所述密封元件在所述插管刺穿小瓶塞之前就接触到了小瓶塞。
4.根据权利要求1所述的装置,其特征在于,所述密封元件的硬度等级低于肖氏A级硬度50。
5.根据权利要求1所述的装置,其特征在于,所述密封元件的硬度等级范围为肖氏A级硬度5-35。
Applications Claiming Priority (3)
Application Number | Priority Date | Filing Date | Title |
---|---|---|---|
IL202069 | 2009-11-12 | ||
IL202069A IL202069A0 (en) | 2009-11-12 | 2009-11-12 | Fluid transfer device with sealing arrangement |
PCT/IL2010/000854 WO2011058545A1 (en) | 2009-11-12 | 2010-10-19 | Fluid transfer devices with sealing arrangement |
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CN102985047A CN102985047A (zh) | 2013-03-20 |
CN102985047B true CN102985047B (zh) | 2015-07-01 |
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CN201080051201.4A Active CN102985047B (zh) | 2009-11-12 | 2010-10-19 | 带密封结构的流体转移装置 |
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US (1) | US8608723B2 (zh) |
EP (1) | EP2490647B1 (zh) |
JP (1) | JP5507700B2 (zh) |
CN (1) | CN102985047B (zh) |
BR (1) | BR112012011419B1 (zh) |
DK (1) | DK2490647T3 (zh) |
ES (1) | ES2446972T3 (zh) |
IL (2) | IL202069A0 (zh) |
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Also Published As
Publication number | Publication date |
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CN102985047A (zh) | 2013-03-20 |
WO2011058545A1 (en) | 2011-05-19 |
IL219570A (en) | 2017-02-28 |
US20120220978A1 (en) | 2012-08-30 |
EP2490647A1 (en) | 2012-08-29 |
US8608723B2 (en) | 2013-12-17 |
IN2012DN03351A (zh) | 2015-10-23 |
IL202069A0 (en) | 2010-06-16 |
EP2490647B1 (en) | 2013-12-18 |
JP2013510633A (ja) | 2013-03-28 |
IL219570A0 (en) | 2012-06-28 |
JP5507700B2 (ja) | 2014-05-28 |
BR112012011419A2 (pt) | 2016-05-03 |
ES2446972T3 (es) | 2014-03-11 |
DK2490647T3 (en) | 2014-03-10 |
BR112012011419B1 (pt) | 2020-01-07 |
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