CN109310574B - 用于用液体药物内含物填充药泵筒的流体转移装置 - Google Patents

用于用液体药物内含物填充药泵筒的流体转移装置 Download PDF

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CN109310574B
CN109310574B CN201780034925.XA CN201780034925A CN109310574B CN 109310574 B CN109310574 B CN 109310574B CN 201780034925 A CN201780034925 A CN 201780034925A CN 109310574 B CN109310574 B CN 109310574B
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伊格·德仁伯格
乌瑞·大卫
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West Pharma Services IL Ltd
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Abstract

流体转移装置，该流体转移装置用于用液体药物内含物填充药泵筒用于给药目的。流体转移装置包括双末端开口的圆筒，该双末端开口的圆筒被横向的分割物分割为用于伸缩地安装在药瓶上的药瓶端口和用于滑动地接收活塞头的末端开口的活塞筒，包括药泵筒端口，用于伸缩地安装在药泵筒的前导的筒端上。滑动插入活塞头进入该活塞筒中以邻接靠在横向的分割物上推动被保留在压缩室中的空气进入该药瓶中，这反过来推动它的液体药物内含物进入通气式药泵筒中。

Description

用于用液体药物内含物填充药泵筒的流体转移装置
技术领域
本发明涉及用于用液体药物内含物填充药泵筒的流体转移装置。
背景技术
用于自身给与液体药物的药泵通常利用所谓的药泵腕或药泵筒(drug pumpcarpules or cartridges)，该药泵腕或药泵筒包括在前导的筒端由筒膜气密封的末端开口的筒管和在相反的尾随的筒端的可滑动的驱动泵塞。药泵筒不是预先填充有准备用于直接给药的液体药物内含物而是被提供是空的或预填充有用于重构或稀释目的的稀释剂。因此，药泵筒被要求在插入到药泵中之前被填充液体药物内含物。
药泵必须被校准以考虑药泵筒的可滑动的驱动泵塞的静摩擦性能和动摩擦性能。但是在用来用液体药物内含物填充药泵筒的液体药物填充过程期间移动可滑动的驱动泵塞很大程度地改变它的静摩擦性能和动力摩擦性能。再者，在移动它们的可滑动的驱动泵塞之后药泵筒具有相对大的它们的摩擦性能的改变。因此，药泵筒优选被设置有它的可滑动的驱动泵塞，该药泵筒密封地包围最大的剂量体积，该最大的剂量体积等于或大于需要的用于给药目的的液体药物内含物的剂量体积，而不需要移动它的可滑动的驱动泵塞从而提供可靠的经校准的操作药泵。
共同拥有的PCT国际申请号PCT/IL2007/000343(发明名称：与筒一起使用的流体转移装置，以PCT国际公开号WO 2007/105221公布)公开了流体转移装置，该流体转移装置需要使用无针注射器用来填充药泵筒，而不需要移动它的可滑动的驱动泵塞，从而提供了药泵的可靠校准操作。
共同拥有的PCT国际申请号PCT/IL2011/000530(发明名称：用来用液体药物剂量填充筒的流体转移装置，以PCT国际公开号WO 2011/004360公布)公开了流体转移装置，该流体转移装置不需要使用注射器填充药泵筒，而是移动它的可滑动的驱动泵塞，从而排除了药泵的可靠校准操作。
同样，美国专利号6,752,180(Delay，发明名称：用于在小瓶和卡普耳之间双向转移液体的装置)公开了流体转移装置，该流体转移装置还移动药泵筒的可滑动的驱动泵塞，从而排除了药泵的可靠校准操作。
需要流体转移装置，该流体转移装置用于填充药泵筒，而不移动它的可滑动的驱动泵塞用于药泵的可靠校准操作。
发明内容
一般来说，本发明针对的是流体转移装置，该流体转移装置用于用液体药物内含物填充药泵筒用于给药目的。液体药物内含物的剂量体积在填充药泵之前是已知的，因此，药泵筒可被设置有它的可滑动的驱动泵塞，它的可滑动的驱动泵塞密封地包围等于或大于液体药物内含物的剂量体积的最大剂量体积使得它可被填充，而没有移动它的可滑动的驱动泵塞，从而保证药泵的可靠校准操作。本发明的流体转移装置可被分为以下两种类型：第一，从药瓶转移准备用于给药的液体药物内含物以填充初始空的药泵筒。以及第二，从初始地预先填充的药泵筒转移液体内含物到药瓶中用于在药瓶中形成液体药物内含物并且在这之后从该药瓶转移液体药物内含物到该药泵筒。后者类型必然与负压下的药瓶一起使用用于实现从初始地预先填充的药泵筒正压抽取液体内含物到药瓶中用于重构或稀释目的。
第一类型的流体转移装置具有纵向的流体转移装置中心线并且包括双末端开口的圆筒，该双末端开口的圆筒由横向的分割物(transverse partition)分割为用于伸缩地安装在药瓶上的药瓶端口和用于滑动地接收活塞头的末端开口的活塞筒，其包括用于伸缩地安装在药泵筒的前导的筒端上的药泵筒端口。在组装时，该药瓶与该药泵筒连续的液体流体连通。该药泵筒是通气的。该活塞头与横向的分割物初始地间隔开以密封压缩室。该活塞头到活塞筒中的滑动插入用以邻接靠在横向的分割物上，推动被保留在压缩室的空气进入该药瓶中，这反过来推动它的液体药物内含物进入通气式药泵筒中。
第二类型的流体转移装置与第一类型相似并且还包括手动操作的流体控制装置用于选择性地打开或关闭药瓶和压缩室之间的流体连通用来实现从初始地预先填充的药泵筒正压抽取液体内含物到药瓶中。
附图的简要说明
为了理解本发明并且明白如何在实践中实施它，仅仅借助非限制性实例，参照附图，其中类似的部件被做了同样标记，现在描述优选的实施例，其中：
图1是根据本发明的第一优选实施方案，包括药泵筒、药瓶和流体转移装置的成套装置的示图；
图2是药泵筒的纵向截面图；
图3是图1的流体转移装置的底部透视图；
图4是图1的流体转移装置在它的初始安装位置沿着图1中的线4-4的纵向截面图；
图5是图1的流体转移装置在它的初始安装位置沿着图1中的线5-5的纵向截面图；
图6是活塞头的前面的透视图；
图7是活塞头的正视图；
图8是沿着图7中的线8-8的活塞头的纵向截面图；
图9A是流体转移组合件的纵向截面图，该流体转移组合件包括图1流体转移装置、药瓶和将液体药物内含物转移到药泵筒之前的药泵筒；
图9B是流体转移组合件的纵向截面图，该流体转移组合件包括图1流体转移装置、药瓶和将液体药物内含物转移到药泵筒之后的药泵筒；
图10A到图10D显示了用来用液体药物内含物填充药泵筒准备用于向患者给药的图1成套装置的使用；
图11是根据本发明的第二优选实施方案，包括药泵筒、药瓶和包括手动操作的流体控制装置的流体转移装置的成套装置的示图；
图12是图11流体转移装置的分解图；
图13是手动操作的流体控制装置(manual operated flow controlarrangement)的L形流体控制部件的正视图；
图14是沿着图13中的线14-14的L形流体控制部件的截面图；
图15A是流体转移组合件的侧视图，该流体转移组合件包括图11流体转移装置，药瓶和用于从药泵筒抽取液体内含物到药瓶的药泵筒，流体控制装置处于初始闭合状态、；
图15B是图15A流体转移组合件沿着图15A中线15B-15B的纵向截面图；
图16A是流体转移组合件的侧视图，该流体转移组合件包括图11流体转移装置，药瓶和准备用于从药瓶转移液体药物内含物到药泵筒的药泵筒，流体控制布置处于最终开放状态；
图16B是沿着图16A中线16B-16B的图16A流体转移组合件的纵向截面图；以及
图17A到图17E显示了用于用液体药物内含物填充药泵筒准备用于向患者给药的图11成套装置的使用。
本发明的优选实施方案的详细描述
液体药物内含物从药瓶到初始空的药泵筒的转移
图1显示了成套装置100，成套装置100包括初始空的药泵筒(drug pumpcartridge)10A、包含液体药物内含物的药瓶30A和流体转移装置40A，流体转移装置40A用于从药瓶30A转移液体药物内含物到药泵筒10A。流体转移装置40A具有纵向的流体转移装置中心线41并且包括双末端开口的圆筒42。
图2显示了药泵筒10A具有纵向的药泵筒中心线11并且包括末端开口的筒管12、小直径的前导的筒端13、中间颈14和宽直径的尾随的筒端16。前导的筒端13由筒膜(cartridge septum)17气密封，筒膜17由金属带18盖住。前导的筒端13具有暴露的2mm到3mm直径的圆形的膜表面19。尾随的筒端16是由可滑动的驱动泵塞21气密封用于限定筒室22，筒室22的体积可从零变化到最大剂量体积V1，当可滑动的驱动泵塞21被完全插入并且邻接靠在前导的筒端13时该体积为零。
图1显示了药瓶30A具有纵向的药瓶中心线31并且包括由药瓶瓶塞33初始地气密封的顶部开口的小瓶瓶体32，药瓶瓶塞33由金属带34盖住。药瓶30A包含已知剂量体积V2的液体药物内含物36，用于给药目的。液体药物内含物36可以借助常规的母药瓶转接器和包含稀释剂或活性液体化合物的无针注射器准备。
现在转到图3到图8，双末端开口的圆筒(dual open ended barrel)42包括横向的分割物(transverse partition)43，横向的分割物43将双末端开口的圆筒42分割成用于伸缩地安装在药瓶30A上的药瓶端口44和末端开口的活塞筒46。药瓶端口44包括弹性部件47，弹性部件47具有向内指向的突出物48用于常规地卡扣配合在药瓶30A上。横向的分割物43与纵向的中心的双腔穿刺套管49一起形成，纵向的中心的双腔穿刺套管49在伸缩地安装流体转移装置40A在药瓶30A上时延伸到药瓶端口44中用于刺穿药瓶瓶塞33。双腔穿刺套管49包括液体腔51和空气腔52。液体腔51具有比空气腔52大的腔直径。
流体转移装置40A包括活塞头53，活塞头53具有前导的活塞头端53A和尾随的活塞头端53B。活塞头53滑动地插入到活塞筒46中使得前导的活塞头端53A与横向的分割物43一起限定压缩室(compression chamber)54。活塞头53与纵向的转移管56一起形成用于延伸通过压缩室54并且经设计形状和尺寸用于密封滑动插入在液体腔51中。转移管56包括在流体转移装置40A的初始安装位置被插到液体腔51中的转移管尖端56A。
活塞头53与药泵筒端口57一起形成，药泵筒端口57远离横向的分割物43用于紧贴地安装在前导的筒端13上。药泵筒端口57与径向的指向的叶片58一起形成用于稳定活塞头53在活塞筒46中的移动。药泵筒端口57与穿刺套管59一起形成用于在其中滑动插入前导的筒端13时刺穿筒膜17。穿刺套管59与转移管56流体连通使得穿刺套管59与液体腔51流体连通。药泵筒端口57与通气式穿刺套管61一起形成用于在其中滑动插入前导的筒端13时刺穿筒膜17。通气式穿刺套管61在相邻的叶片58之间通气。
流体转移装置40A经设计使得在伸缩地安装流体转移装置40A在药泵筒10A上时，药泵筒端口57在活塞头53在活塞筒46中开始滑动之前刺穿筒膜17。
图9A和图9A显示了流体转移装置40A的两个操作位置，如下：
图9A显示了初始的安装位置，其中药瓶端口44伸缩地被安装在初始满的药瓶30A上，药泵筒端口57伸缩地被安装在初始空的药泵筒10A上并且活塞头53与横向的分割物43间隔开。转移管尖端56A在液体腔51中。压缩室54包含被保留的空气。
图9B显示了最终的填充位置，其中活塞头53邻接靠在横向的分割物43上并且转移管56几乎完全被插到液体腔51中。活塞头53到活塞桶46中的滑动插入推动压缩室54中的被保留的空气进入药瓶30A(如图9A中的箭头A所示)。推动被保留的空气进入药瓶30A中反过来推动液体药物内含物36从药瓶30A进入到药泵筒10A中，如箭头B所示。推动液体药物内含物36进入药泵筒10A中通过通气式穿刺套管61排出空气，如箭头C所示。在填充过程中，可滑动的驱动泵塞21保持在离筒膜17的相同位移处。
图10A到图10D显示了成套装置100用于从药瓶30A转移液体药物内含物36到初始空的药泵筒10A中的使用。药泵筒10A被设置有它的可滑动的驱动泵塞21，它的可滑动的驱动泵塞21初始地与筒膜17间隔开用于密封筒室22，筒室22具有等于或大于已知剂量体积V2的最大剂量体积V1，为了在填充药泵筒10A期间从它的初始位置不移动可滑动的驱动泵塞21。在V1＝V2的情况下，筒室22完全地是由液体药物内含物36填充使得在操作药泵时液体药物内含物直接从药泵筒10A被泵出。在V1>V2的情况下，套筒室22部分地由液体药物内含物36填充使得在从药泵筒10A泵出液体药物内含物之前药泵初始地排出药泵筒10A中的空气。图10A到图10D显示了在最大剂量体积V1和剂量体积V2相同的情况下成套装置100用于转移液体药物内含物的使用。
图10A显示了伸缩地安装流体转移装置40A在药瓶30A上用于刺穿药瓶30A。液体腔51和空气腔52与药瓶瓶体32流体连通。
图10B和图10C显示了倒置流体转移装置40A和药瓶30A以及单个连续的插入冲程(single continuous insertion stroke)用于安装流体转移装置40A在药泵筒10A上以从药瓶30A转移液体药物内含物36到药泵筒10A中。该单个连续的插入冲程有效地进行了两个连续动作，如下：
图10B显示了将药泵筒端口57伸缩地安装在前导的筒端13上以形成流体转移组合件101。穿刺套管59和通气式穿刺套管61刺穿筒膜17以与套筒室22流体连通。流体转移组合件101具有初始的安装高度H1。
图10C显示了活塞头53完全插入到活塞筒46中用于邻接靠在横向的分割物43上用来从药瓶30A转移液体药物内含物36到药泵筒10A，而不需要移动可滑动的驱动泵塞21。流体转移组合件101被插入冲程的长度压紧到最终的填充高度H2，其中H1>H2。
图10D显示了目前填充的药泵筒10A从流体转移装置40A的拆除用于插入到药泵中用于向患者投与液体药物内含物36。流体转移装置40A和现在空的药瓶30A可被丢弃。
从预先填充的药泵筒转移液体内含物到药瓶用于在药瓶中形成液体药物内含物 并且随后从药瓶转移液体药物内含物到药泵筒
图11显示了成套装置200，成套装置200包括预先填充的药泵筒10B、药瓶30B和流体转移装置40B，流体转移装置40B用于用液体药物内含物填充药泵筒10B。药泵筒10B预先填充有呈稀释剂形式或呈活性液体成分形式的液体内含物23。药瓶30B必然处在负压下并且包含呈粉末或液体形式的药剂37。流体转移装置40B与流体转移装置40A类似并且在以下两个方面不同：第一，流体转移装置40B包括手动操作的流体控制装置62，手动操作的流体控制装置62用来初始地关闭空气腔52并且选择性地打开空气腔52用于相应地实现从药泵筒10B初始地正压抽取液体内含物到药瓶30B中用于初始在药瓶30B中准备液体药物内含物36并且随后从药瓶30B转移液体药物内含物36到药泵筒10B。以及第二，流体转移装置40B优选地防止活塞头53的疏忽地插入冲程直至从药泵筒10B正压抽取液体内含物到药瓶30B中之后。
流体转移装置40B包括在横向的分割物43中的用来横断空气腔52的横向的指向的盲孔63。盲孔63具有垂直于流体转移装置中心线41的盲孔中心线64。流体控制装置62包括手动旋转的L形流体控制部件66，手动旋转的L形流体控制部件66具有流体控制部件腿(flow control member shank)67和流体控制部件柄68。流体控制部件腿67延伸到盲孔63中并且围绕旋转轴69是可旋转的，旋转轴69与盲孔中心线64重合。流体控制部件柄68与双末端开口的圆筒42齐平。流体控制部件腿67具有前导的流体控制部件腿端(leading flowcontrol member shank end)67A，前导的流体控制部件腿端67A横断空气腔52。前导的流体控制部件腿端67A与偏离旋转轴69的贯穿孔71一起形成。
尾随的活塞头端(trailing piston head end)53B与L形停止部件72一起形成，L形限位部件72包括横向的小的L形限位部件腿(transverse minor L-shaped stop memberleg)73和纵向的大的L形限位部件腿(longitudinal major L-shaped stop member leg)74，纵向的大的L形限位部件腿74朝向前导的活塞头端53A指向。活塞筒46形成有纵向的指向的缝隙76，纵向的指向的缝隙76延伸活塞头53进入活塞筒46的插入冲程的长度。
图15A和图15B显示了在初始闭合状态用于关闭空气腔52的流体控制装置62。流体转移装置40B被设计使得大的L形限位部件74和流体控制部件柄68在初始闭合位置邻接用于在从药泵筒10B转移液体内含物23到药瓶30B中用于在药瓶30B中形成液体药物内含物36之前防止活塞头53进入活塞筒46中的疏忽的插入冲程。
图16A和图16B显示了在最终的开放状态用于通过半转动旋转流体控制部件柄68打开空气腔52的流体控制装置62，其还实现了活塞头53到活塞筒46中的插入冲程。
图17A到图17E显示了，针对最大剂量体积V1和用于给药目的的液体药物内含物36的剂量体积V2是相同的情况，成套装置200的使用。流体转移装置40B处于它的初始安装状态，流体控制部件66关闭空气腔52并且活塞头53与横向的分割物43间隔开准备用于它的朝向横向的分割物43的插入冲程。
图17A显示了将流体转移装置40B伸缩地安装在药泵筒10B用于刺穿药泵筒10B。
图17B显示了倒置流体转移装置40B和药泵筒10B用于伸缩地安装在药瓶30B上以将液体内含物23从药泵筒10B转移到药瓶30B，这由药泵筒10B的通气来促进的。液体内含物23重构粉末药剂37以形成剂量体积V2的液体药物内含物36。药泵筒10B、药瓶30B和流体转移装置40B形成具有初始安装高度H1的流体转移组合件201。
图17C显示了倒置流体转移组合件201并且半转动旋转(half turn rotation)流体控制部件柄68用于打开空气腔52。
图17D显示了在活塞头53到活塞筒46中的插入冲程用于从药瓶30B转移液体药物内含物36到药泵筒10B之后的流体转移组合件201，没有以类似流体转移组合件101的方式移动可滑动的驱动泵塞21。流体转移组合件201被压紧到最终的填充高度H2，其中H1>H2。
图17E显示了现在填充的药泵筒10B从流体转移装置40B拆除用于插入到药泵中用于向患者投与液体药物内含物36。流体转移装置40B和现在空的药瓶30B可被丢弃。
虽然本发明已经描述了有限数目的实施方案，应理解，本发明的许多变化、修改和其它应用可在所附的权利要求书的范围内做出。

Claims (5)

1.流体转移装置，所述流体转移装置用于与药瓶和药泵筒一起使用用来从药瓶转移液体药物内含物到药泵筒中，
所述药瓶具有由药瓶瓶塞密封的顶部开口的药瓶瓶体并且包含剂量体积的液体药物内含物用于给药目的，
所述药泵筒具有末端开口的筒管，所述筒管具有前导的筒端，密封所述前导的筒端的筒膜，可滑动的驱动泵塞，所述可滑动的驱动泵塞距离筒膜一定距离用于密封最大剂量体积，所述最大剂量体积等于或大于液体药物内含物的剂量体积，
所述流体转移装置包括：
(a)双末端开口的圆筒，所述双末端开口的圆筒具有纵向的圆筒中心线和横向的分割物，所述横向的分割物将所述双末端开口的圆筒分割为用于伸缩地安装在所述药瓶上的药瓶端口和末端开口的活塞筒，
所述分割物具有双腔药瓶瓶塞穿刺套管，所述双腔药瓶瓶塞穿刺套管延伸到所述药瓶端口中用于在所述伸缩地安装所述药瓶端口在所述药瓶上时刺穿所述药瓶瓶塞，
所述双腔药瓶瓶塞穿刺部件包括液体腔和空气腔；以及
(b)活塞头，所述活塞头滑动地安装在所述末端开口的活塞筒中以与所述横向的分割物一起密封压缩室，
所述压缩室与所述空气腔流体连通，
所述活塞头具有药泵筒端口，用于伸缩地安装在所述前导的筒端上，
所述药泵筒端口包括大的筒膜刺穿套管和小的筒膜刺穿套管用于在所述伸缩地安装所述药泵筒端口在所述前导的筒端上时刺穿所述筒膜，
所述大的筒膜刺穿套管与所述液体腔密封地流体连通用于在所述药瓶和所述药泵筒之间液体转移，
所述小的筒膜刺穿套管在所述伸缩地安装所述药泵筒端口在所述前导的筒端上时与所述药泵筒通气，
所述流体转移装置具有初始的安装位置和最终的填充位置，在所述初始的安装位置，所述活塞头与所述横向的分割物间隔开用于将空气保留在所述压缩室中，在所述最终的填充位置，所述活塞头沿着插入冲程朝向所述横向的分割物滑动地插入用来推动被保留的空气进入所述药瓶中用于推动所述药瓶的剂量体积的液体药物内含物进入所述药泵筒中，没有移动可滑动的驱动泵塞。
2.根据权利要求1所述的装置，其用来与负压的药瓶和包含液体内含物的预先填充的药泵筒一起使用并且进一步包括手动操作的流体控制装置用于选择性地打开和关闭所述空气腔，
所述流体控制装置具有初始的闭合状态用于在所述初始的安装位置关闭所述空气腔用于实现在初始地伸缩地安装所述药泵筒端口在所述前导的筒端上并且随后伸缩地安装所述药瓶端口在所述药瓶上时从所述药泵筒正压抽取液体内含物到所述药瓶中用于在所述药瓶中形成液体药物内含物，以及
所述流体控制装置具有随后的打开状态用于打开所述空气腔，用于实现当将所述活塞筒中的所述活塞头从所述初始的安装位置滑动插入到所述最终的填充位置时推动所述被保留的空气从所述压缩室进入所述药瓶中用于从所述药瓶转移液体药物内含物到通气式药泵筒。
3.根据权利要求2所述的装置，其中所述流体控制装置包括手动可旋转的流体控制部件，所述手动可旋转的流体控制部件具有横断所述空气腔的流体控制部件腿和用于旋转所述流体控制部件的流体控制部件柄。
4.根据权利要求3所述的装置，其中所述活塞头包括限位部件，所述限位部件用于在所述初始的闭合状态邻接靠在所述流体控制部件柄上，用于防止在所述初始的安装位置将所述活塞头滑动插入所述末端开口的活塞筒中。
5.根据权利要求1到4任一项所述的装置，其中所述横向的分割物包括从所述药泵筒端口相反指向的转移管，所述转移管用于从所述初始的安装位置的初始部分插入，滑动插入在所述液体腔中。
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