CN110290820A - 注射器组件 - Google Patents

注射器组件 Download PDF

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CN110290820A
CN110290820A CN201780048976.8A CN201780048976A CN110290820A CN 110290820 A CN110290820 A CN 110290820A CN 201780048976 A CN201780048976 A CN 201780048976A CN 110290820 A CN110290820 A CN 110290820A
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bottle
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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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    • A61M5/3295—Multiple needle devices, e.g. a plurality of needles arranged coaxially or in parallel
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    • A61J1/00—Containers specially adapted for medical or pharmaceutical purposes
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    • A61J1/00—Containers specially adapted for medical or pharmaceutical purposes
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    • 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
    • A61J1/2048—Connecting means
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    • A61M5/00—Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
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    • A61M5/00—Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
    • A61M5/178—Syringes
    • A61M5/31—Details
    • A61M2005/3117—Means preventing contamination of the medicament compartment of a syringe
    • A61M2005/3118—Means preventing contamination of the medicament compartment of a syringe via the distal end of a syringe, i.e. syringe end for mounting a needle cannula
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Abstract

注射器组件，该注射器组件包括注射器，该注射器预先装配有一体的液体药物施用装置和药瓶转接器，该一体的液体药物施用装置用于实现液体药物内含物的施用，该药瓶转接器用于伸缩地安装在包含液体药物内含物的药瓶上。该药瓶转接器初始地安装在注射器上并且被用于手动地从该注射器拆除以暴露该一体的液体药物施用装置。该注射器包括具有初始流程位置和最后流程位置的流体控制部件，该初始流程位置用于实现用来自该药瓶的液体药物内含物填充该注射器，该最后流程位置用于实现液体药物内含物的施用。药瓶转接器从注射器的拆除将该流体控制部件从它的初始流程位置推动到它的最后流程位置。

Description

注射器组件
技术领域
本发明涉及注射器组件。
背景技术
包含准备用于直接施用的液体药物剂量的预先填充的注射器装配有一体的标准的肌内注射针用于肌内注射到大约1cm的深度或一体的肤内的微针用于肤内注射到大约2-3mm的深度。或者，预先填充的注射器具有加宽的远侧的注射器尖端，防止标准的鲁尔接头的针头接口(standard Luer connector needle hub)的拆除并且预期用于经口施用液体药物剂量。预先填充的装配有针的注射器具有比约0.03ml到0.05m1的标准的鲁尔接头死体积小得多的死体积，对于某种疫苗来说，其比得上疫苗剂量，这可导致相当大的疫苗浪费。
预先填充的注射器用液体药物剂量填充，这作为制造预先填充的注射器的制造过程的一部分。具有一体的针或加宽的远侧的注射器尖端的注射器在使用前由临床执业医生用液体药物剂量填充，但是这样手动的填充过程通常被认为是耗费时间的并且是有问题的。PCT国际申请号PCT/GB2014/051256(发明名称：注射器，以PCT国际公开号WO 2014/174278公布)公开了用于帮助用来自包含液体药物剂量的药瓶的液体药物剂量填充初始空的注射器的注射器组件。
需要注射器组件，该注射器组件包括具有一体的液体药物施用装置的注射器，该一体的液体药物施用装置在使用之前很容易直接用液体药物内含物填充。
发明内容
本发明针对的是注射器组件，该注射器组件包括预先装配有一体的液体药物施用装置的注射器和药瓶转接器。该一体的液体药物施用装置可以是标准的肌内注射针(intramuscular needle)、标准的皮内微针(intradermal micro-needle)、加宽的远侧的注射器尖端(widened distal syringe tip)等。该药瓶转接器初始地被安装在注射器上并且被用于手动地从注射器拆除以暴露该一体的液体药物施用装置用于实现液体药物内含物的施用。该注射器包括流体控制部件，该流体控制部件具有初始流程位置(initial flowpath position)和最后流程位置(final flow path position)，该初始流程位置用于实现用来自药瓶的液体药物内含物手动填充该注射器，该最后流程位置用于实现手动施用液体药物内含物。该药瓶转接器从该注射器的拆除将该流体控制部件从它的初始流程位置推动到它的最后流程位置。该药瓶转接器从注射器的拆除可以通过该药瓶转接器相对于该注射器的手动旋转或线性拆除。
本发明的注射器组件优选地被提供有空的注射器。注射器组件可以与包含液体药物内含物的药瓶一起使用，该液体药物内含物准备用于直接抽取到空的注射器。对于包含粉末药剂的药瓶，注射器组件优选地额外地包括液体瓶转接器，该液体瓶转接器用于伸缩地安装在包含用于与该粉末药剂混合的液体内含物的液体瓶上。该液体内含物可以仅仅是用于重构的稀释剂或可以包括活性成分。此类注射器组件利用它的初始流程位置用于如下的三个液体转移：用于将液体内含物从该液体瓶抽取到该空的注射器的第一液体转移。该液体瓶转接器和它的空的液体瓶在该第一次液体转移之后必须从该注射器组件拆除以实现伸缩地安装在包含该粉末药剂的药瓶上。用于将来自注射器的液体内含物注射到药瓶中以形成液体药物内含物的第二液体转移。和用于将液体药物内含物从该药瓶抽取到该空的注射器中的第三液体转移。
附图说明
为了理解本发明并且明白如何在实践中实施它，仅仅通过非限制性实例，参照附图，其中类似的部件被做了同样标记，现在优选的实施例被描述，并且其中：
图1是在初始的安装位置用来与包含液体药物内含物的药瓶一起使用的注射器组件的透视图；
图2是准备用于施用液体药物内含物的注射器组件的透视图；
图3是注射器组件的分解图；
图4是沿着图1中的线A-A的注射器组件的纵向截面图和圆形区域A的放大；
图5是沿着图2中的线B-B的注射器组件的纵向截面图和圆形区域B的放大；
图6A到图6C显示了注射器组件用于施用液体药物内含物的使用；
图7是具有用于经口施用液体药物内含物的加宽的远侧的注射器尖端(wideneddistal syringe tip)的注射器的透视图和圆形区域C的放大；
图8是替代的注射器组件的分解图；
图9是图8的注射器组件的流体控制部件的后视图；
图10是具有它的流体控制部件在初始流程位置的图8的注射器组件的纵向截面图和圆形区域D的放大；
图11是具有它的流体控制部件在最后流程位置的图8的注射器组件的纵向截面图和圆形区域E的放大；
图12是图8的注射器组件的纵向截面图，该注射器组件经更改用来与包含粉末药剂的药瓶和包含液体内含物的液体瓶一起使用；以及
图13A到图13G显示了用于重构和施用液体药物内含物的图12注射器组件的使用。
本发明的优选实施方案的详述
图1到图5显示了用来与药瓶10一起使用的注射器组件100A。药瓶10具有纵向的药瓶中心线11并且包括药瓶瓶管12、具有药瓶瓶冠开口14的管状的药瓶瓶冠13和在药瓶瓶管12和药瓶瓶冠13中间的窄直径药瓶瓶颈16。药瓶10包括在药瓶管12和药瓶瓶颈16中间的药瓶瓶肩17。药瓶10包括用于塞住药瓶瓶冠开口14的药瓶瓶塞18。药瓶10包含液体药物内含物19。药瓶10预先填充有液体药物内含物或在它与注射器组件100A一起使用之前液体药物内含物在其中重构。
注射器组件100A具有纵向的注射器组件中心线101并且包括具有近侧注射器端(proximal syringe end)103和远侧注射器尖端(distal syringe tip)104的注射器102和药瓶转接器106。注射器102包括末端开口的注射器筒107，末端开口的注射器筒107具有近侧注射器筒端107A、远侧注射器筒端107B和注射器筒内部108。注射器102包括具有拇指限位部件(thumb stop)111的活塞109。近侧注射器端103具有一对正好相反的手指握持物(fingers grips)112。远侧注射器尖端104与横向于纵向的注射器组件中心线101的环形凸缘113一起形成。环形凸缘113与外部螺纹114一起形成。远侧注射器尖端104与横向指向的腔116一起形成，横向指向的腔116在远侧注射器筒端107B和孔117之间延伸，相对近侧注射器端103A，孔117在环形凸缘113的远侧形成。
远侧注射器尖端104具有与纵向的注射器组件中心线101同轴的液体药物分配腔119。液体药物分配腔119与由标准的皮内注射针构成的一体的液体药物施用装置121配合。远侧注射器尖端104具有从远侧注射器筒端107B朝向皮内注射针121逐渐变细的锥形的外围的注射器尖端表面122。远侧注射器尖端104具有与横向指向的腔116间隔开的横向指向的腔123。横向指向的腔123在液体药物分配腔119和外围远侧注射器尖端表面122中的孔124之间延伸。两个横向指向的腔116和123位于穿过纵向的注射器组件中心线101的纵向的平面上。
注射器102包括流体控制部件126，流体控制部件126具有用于紧贴地嵌套在远侧注射器尖端104和药瓶转接器106之间的管状的构造。流体控制部件126具有近的顶侧127和远的底侧128。流体控制部件126具有锥形的贯穿孔129，贯穿孔129具有与外围远侧注射器尖端面122密封接触的内部的流体控制部件表面131。底侧128与一对正好相反的凹槽132A和132B一起形成。流体控制部件126具有一对正好相反的流道用于与横向指向的腔116流体连通用于在两个流程位置的相应使用，如下：纵向的指向的腔133偏离纵向的注射器组件中心线101用在初始流程位置。腔133延伸于在内部的流体控制部件表面131中形成的孔134和凹处132A之间。并且在内部的流体控制部件表面131中形成的凹槽136用于在最后流程位置的两个横向指向的腔116和123之间的流体连通。凹槽136具有近侧凹槽端137和远侧凹槽端138。孔134和近侧凹槽端137在横向于纵向的注射器组件中心线101的同一平面上是正好相反的。
药瓶转接器106具有管状的构造并且包括近侧直立的杆(stem)139，用于伸缩地安装在药瓶10上的远侧向下垂悬的裙141和在直立的杆139和向下悬垂的裙141之间的中间颈142。直立的杆139具有一对正好相反的向内指向的螺纹突出物143用于螺纹安装在外部螺纹114上。药瓶转接器106需要半转以从远侧注射器尖端104拆除并且同时转动流体控制部件126从它的初始流程位置到它的最后流程位置。直立的杆139和中间颈142包围远侧注射器尖端104和流体控制部件126。裙141包括一对正好相反的纵向的指向的孔144和穿刺套管147，纵向的指向的孔144具有向内指向的突出物146用于卡扣安装在药瓶瓶冠13上，穿刺套管147具有穿刺套管端147A用于在卡扣安装在药瓶10上时刺穿药瓶瓶塞18。颈142包括一对正好相反的突出物148A和148B用于相应地紧贴地插入到该对正好相反的凹处132A和132B中。刺穿套管147包括延伸于突出物148A中的孔151和位于穿刺套管端147A的孔152之间的腔149。
图4显示了注射器组件100A具有在注射器筒内部108和穿刺套管147之间通过腔116、腔133和腔149的初始流程。图5显示了注射器组件100A具有在注射器筒内部108和皮内注射针121之间通过腔116、凹槽136和液体药物分配腔119的最后流程。
图6A到图6C显示了注射器组件100A的使用，如下：图6A显示了在初始安装位置的注射器组件100A，其中药瓶转接器106可拆除地安装在远侧注射器尖端104上。活塞109在完全插入位置并且流体控制部件126在它的初始流体控制位置，如图4所示。临床执业医生将药瓶转接器106伸缩地安装在药瓶10上用于刺穿药瓶10。图6B显示了临床执业医生将注射器组件100A和穿刺药瓶10倒置以将液体药物内含物从药瓶10抽取到注射器102中，如箭头A所示。图6C显示了临床执业医生将注射器组件100A和现在空的药瓶10倒置到它的直立位置。临床执业医生通过半旋转转动药瓶转接器106以将它连同空药瓶10从远侧注射器尖端104拆除以暴露皮内注射针121并且将流体控制部件126推动到它的最后流程位置。注射器102准备用于施用液体药物内含物19。
图7显示了注射器组件100B，注射器组件100B包括具有加宽的远侧注射器尖端104的注射器102，加宽的远侧注射器尖端104由一体的液体药物施用装置构成用于经口施用液体药物内含物。
图8到图11显示了在构造和使用上类似注射器组件100A的注射器组件100C，因此，类似的部件被做了同样编号。后者100C不同于前者100A之处在于它的流体控制装置用于从药瓶抽取液体药物内含物且施用液体药物内含物。
远侧注射器尖端104与横向于纵向的注射器组件中心线101的横向的贯穿孔161一起形成。远侧注射器尖端104包括腔162，腔162与纵向的注射器组件中心线101同轴并且与横向的贯穿孔161的近侧流体连通。远侧注射器尖端104包括液体药物分配腔163，液体药物分配腔163与纵向的注射器组件中心线101同轴并且与横向的贯穿孔161的远侧流体连通。液体药物分配腔163与皮内注射针121配合。
注射器102包括具有密封端166的总体上管状的流体控制部件164。流体控制部件164包括外围的流体控制部件表面167，外围的流体控制部件表面167具有横向的浅的豁槽(transverse flat cutout)168和外围的凹槽169。浅的豁槽168具有第一豁槽端171和第二豁槽端172。外围的凹槽169与第二豁槽端172流体连通。
药瓶转接器106包括与密封端166接触的内部半圆形凸轮表面173。凸轮表面173具有开始凸轮表面端(start cam surface end)174和最后凸轮表面端(final cam surfaceend)176。开始凸轮表面端174具有距离纵向的注射器组件中心线101的间隔S1。最后凸轮表面端176具有距离纵向的注射器组件中心线101的间隔S2。间隔S1比间隔S2大使得药瓶转接器106的旋转将流体控制部件164从初始流程位置推动到最后流程位置。
图10显示了在它的初始流程位置的注射器组件100C，其中开始凸轮表面端174接触密封端166。图10显示了注射器组件100C具有在注射器筒内部108和穿刺套管147之间的通过腔162、浅的豁槽168(在它的第一豁槽端171)、外围的凹槽169和液体药物分配腔163的初始流程。
图11显示了在药瓶转接器106拆除之后，凸轮表面166已经推动流体控制部件164横向地穿过纵向的注射器组件中心线101，注射器组件100C位于它的最后流程位置。图11显示了注射器组件100C具有在注射器筒内部108和皮内注射针121之间的通过腔162、浅的豁槽168(在它的第二豁槽端172)、外围的凹槽169和液体药物分配腔163的最后流程。
图12显示了用来与药瓶20和液体瓶30一起使用的注射器组件100D。药瓶20与药瓶10不同之处在于它包括粉末药剂21。液体瓶30具有纵向的液体瓶中心线31并且包括液体瓶瓶管32、具有液体瓶瓶冠开口34的管状的液体瓶瓶冠33和在液体瓶瓶管32和液体瓶瓶冠33中间的窄直径的液体瓶瓶颈36。液体瓶30包括在液体瓶瓶管32和液体瓶瓶颈36中间的液体瓶瓶肩37。液体瓶30包括用于塞住液体瓶瓶冠开口34的液体瓶瓶塞38。液体瓶30包含用来与粉末药剂21混合以形成液体药物内含物19的液体内含物39。液体内含物39可以是仅仅用于重构目的的稀释剂或包括活性成分。
注射器组件100D还包括用于伸缩地安装在液体瓶30上的液体瓶转接器180。液体瓶转接器180具有横向的液体瓶转接器顶壁181，横向的液体瓶转接器顶壁181与向下垂悬的裙182一起形成用于伸缩地安装在液体瓶30上。液体瓶转接器180与一对正好相反的夹子183一起形成，用于从内侧夹住该对正好相反的纵向的指向的孔144，用来将液体瓶转接器180安装在药瓶转接器106上。夹子183具有向下垂悬的手指操作释放部件(downwarddepending finger operated release members)184，用于当朝向纵向的注射器组件中心线101在手指操作释放部件184上施加按压力时从药瓶转接器106释放液体瓶转接器180。液体瓶转接器顶壁181与直立的锥形端口(upright conical shaped port)186一起形成用于接收穿刺套管147。液体瓶转接器顶壁181与向下垂悬的穿刺套管187一起形成用于当在液体瓶30上伸缩地安装液体瓶转接器180时穿刺液体瓶30。端口186与穿刺套管187持续的流体连通，从而在流体控制部件164的初始流程位置提供注射器102和穿刺套管187之间的流体连通。
图13A到图13G显示了注射器组件100D用于施用液体药物内含物19的使用。图13A显示了在它的初始流程位置的注射器组件100D和具有完全插入的活塞109的空注射器102。临床执业医生将液体瓶转接器180伸缩地安装在液体瓶30上用于刺穿液体瓶30。图13B显示了临床执业医生将注射器组件100D和穿刺的液体瓶30倒置以将液体内含物39从液体瓶30抽取到注射器102中，如箭头B所示。图13C显示了临床执业医生倒置注射器组件100D并且拆除液体瓶转接器180和现在空的液体瓶30。图13D显示了临床执业医生将具有液体内含物39的注射器组件100D伸缩地安装在药瓶20上用于刺穿药瓶20。图13E显示了临床执业医生将液体内含物39注射到药瓶20中(如箭头C所示)以将粉末药剂21重构到液体药物内含物19。图13F显示了临床执业医生将注射器组件100D和被穿刺的药瓶20倒置以将液体药物内含物19从药瓶20抽取到注射器102中，如箭头D所示。图13G显示了临床执业医生将注射器组件100D和现在空的药瓶20倒置到它的竖直位置。临床执业医生通过半转转动药瓶转接器106以将它连同空药瓶20从远侧注射器尖端104拆除以暴露皮内注射针121并且将流体控制部件164推动到它的最后流程位置。注射器102准备用于施用液体药物内含物19。
虽然本发明已经描述了有限数量的实施方案，会理解，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.注射器组件，所述注射器组件用来与药瓶一起使用，所述药瓶具有末端闭合的药瓶瓶管，具有药瓶瓶冠开口的管状的药瓶瓶冠和用于塞住所述药瓶瓶冠开口的药瓶瓶塞，所述药瓶包含液体药物内含物，所述注射器组件具有纵向的注射器组件中心线并且包括：
(a)注射器，所述注射器包括近侧注射器端和远侧注射器尖端，
所述注射器包括末端开口的注射器筒和流体控制部件，所述末端开口的注射器筒具有近侧注射器筒端和远侧注射器筒端，所述流体控制部件从初始流程位置可移动到最后流程位置，
所述远侧注射器尖端具有用于施用液体药物内含物的一体的液体药物施用装置；和
(b)药瓶转接器，所述药瓶转接器包括手动地可拆除地安装在所述远侧注射器尖端的近侧管状的杆、用于伸缩地安装在所述药瓶上的远侧向下垂悬的裙和用于在所述伸缩地安装所述药瓶转接器在所述药瓶上时刺穿所述药瓶瓶塞的穿刺套管，
所述穿刺套管在所述注射器组件的初始安装位置的所述流体控制部件的所述初始流程位置与所述注射器筒流体连通，其中所述药瓶转接器初始地可拆除地安装在所述远侧注射器尖端上，
所述注射器组件是使得在从所述远侧注射器尖端手动拆除所述药瓶转接器时，所述药瓶转接器将所述流体控制部件从所述初始流程位置移动到所述最后流程位置，用于实现所述注射器筒和所述一体的液体药物施用装置之间的流体连通，用于实现施用液体药物内含物。
2.根据权利要求1所述的组件，其中所述手动拆除包括相对所述注射器围绕纵向的注射器组件中心线手动旋转所述药瓶转接器。
3.根据权利要求2所述的组件，其中所述流体控制部件围绕所述纵向的注射器组件中心线是可旋转的并且包括初始流程腔和最后流程腔，所述初始流程腔用于所述初始流程位置中的所述注射器筒和所述穿刺套管之间的流体连通，所述最后流程腔用于所述最后流程位置中的所述注射器筒和所述一体的液体药物施用装置之间的流体连通，以及所述药瓶转接器的所述手动旋转在所述药瓶转接器从所述远侧注射器尖端的拆除期间同时将所述流体控制部件从所述初始流程位置转动到所述最后流程位置。
4.根据权利要求2所述的组件，其中所述流体控制部件相对所述纵向的注射器组件中心线从初始流程位置横向地可移动到最后流程位置，所述初始流程位置用于所述注射器筒和所述穿刺套管之间的流体连通，所述最后流程位置用于所述注射器筒和所述一体的液体药物施用装置之间的流体连通，以及所述药瓶转接器包括内部凸轮表面，所述内部凸轮表面用于在所述手动旋转所述药瓶转接器用于从所述远侧注射器尖端拆除期间横向地将所述流体控制部件从所述初始流程位置移动到所述最后流程位置。
5.根据权利要求1-4中任一项所述的组件，其用来与包含药物内含物的药瓶和液体瓶一起使用，所述液体瓶包括液体瓶瓶管、具有液体瓶瓶冠开口的管状的液体瓶瓶冠和用于塞住所述液体瓶瓶冠开口的液体瓶瓶塞，所述液体瓶包含用于在药瓶中形成液体药物内含物的液体内含物，
所述组件进一步包括液体瓶转接器，所述液体瓶转接器包括可拆除安装装置、向下垂悬的裙、穿刺套管和锥形形状的端口，所述可拆除安装装置用于手动地可拆除地安装从所述药瓶转接器向下垂悬的所述液体瓶转接器，所述向下垂悬的裙用于伸缩地安装在所述液体瓶上，所述穿刺套管用于在所述伸缩地安装所述液体瓶转接器在液体瓶上时刺穿液体瓶瓶塞，所述锥形形状的端口用于在所述安装所述液体瓶转接器在所述药瓶转接器上时接收所述药瓶转接器的穿刺套管。
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