CN102264419B - 注射器和针头去盖器 - Google Patents
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
- 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
- A61M5/32—Needles; Details of needles pertaining to their connection with syringe or hub; Accessories for bringing the needle into, or holding the needle on, the body; Devices for protection of needles
- A61M5/3202—Devices for protection of the needle before use, e.g. caps
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
- 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
- A61M5/32—Needles; Details of needles pertaining to their connection with syringe or hub; Accessories for bringing the needle into, or holding the needle on, the body; Devices for protection of needles
- A61M5/3205—Apparatus for removing or disposing of used needles or syringes, e.g. containers; Means for protection against accidental injuries from used needles
- A61M5/321—Means for protection against accidental injuries by used needles
- A61M5/3213—Caps placed axially onto the needle, e.g. equipped with finger protection guards
- A61M2005/3215—Tools enabling the cap placement
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
- 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
- A61M5/32—Needles; Details of needles pertaining to their connection with syringe or hub; Accessories for bringing the needle into, or holding the needle on, the body; Devices for protection of needles
- A61M5/3202—Devices for protection of the needle before use, e.g. caps
- A61M5/3204—Needle cap remover, i.e. devices to dislodge protection cover from needle or needle hub, e.g. deshielding devices
Abstract
一种用于加载到注射装置的设备,其包括注射器和罩移除器。注射器具有注射器主体、针头和为针头提供无菌盖的罩。罩移除器具有大体上封闭罩和唇或多个唇的主体,该唇向内突出以接合罩和注射器主体之间的接合部。罩移除器在其最宽点具有与注射器主体大体上相同或小于注射器主体的外尺寸。设备可通过装置远端处的开口被加载到注射器装置,以便在加载时,罩移除器的一部分突出通过装置的近端以便于用户移除罩移除器和罩。该布置允许用户通过抓住和拉所述把手而从注射器移除罩。
Description
技术领域
本发明涉及具有注射器针头去盖器的注射器,以及包括该注射器的注射装置。
背景技术
不同类型的注射装置可用来辅助药剂注射入病人(人或动物),并且可配置成接收标准的、预装填的在顶端装有注射针头的玻璃或塑料注射器。这些装置可具有剂量设定机构以及用来将柱塞驱入注射器的主驱动弹簧,以便通过针头将药剂驱除出。注射装置可包括进一步的弹簧,以便在激活主驱动弹簧以排出药剂之前用于将针头推出装置外壳以进入病人皮肤内。
为了在使用之前维持无菌状态,并且避免“针刺”意外,预填充的注射器被提供到具有橡胶或塑料壳或“罩”覆盖针头的注射装置组件。罩具有容纳针头的内空间、邻接注射器主体的相邻端以密封内空间的密封端。在立即使用之前,用户(比如,医疗专业人员或病人)必须移除罩以揭开针头的盖。这通常通过使用罩移除工具(其被用户插入装置的注射端)获得。该工具包括一组簧载指状物,该指状物在工具被推入装置时压制及依靠在罩上。指状物然后咬合注射器和罩之间的连接处。用户可拉出工具,并用它取出盖。
尤其是在昂贵药剂的情况下,使组装注射装置的失效率最小化是特别重要的。考虑到在前述段落中略述的罩移除方案,在指状物中可能难于精确地获得恰当的弹性度,以确保在提供足够的力以在罩的后端封盖接合部的同时可压制住罩。
WO2007/036676(Cilag GmbH International)公开了一种自动注射装置,该装置包括:外壳和在装置的注射端的螺纹的、可移除的防护帽。在恰当位置,帽包围和封闭装置外壳,以及防止装置上的输送锁定机构被松开。帽与罩接合使得帽的移除也可用来移除罩,从而暴露针头,同时释放装置的锁定机构。装置通过将帽置于装置外壳的注射端然后将注射器和罩插入装置而被组装成。帽具有比装置外壳更大的直径,以便能使它包围装置的注射端。
WO2007/047200(EIi Lilly&Co.)提供了一种包括外壳和向外展开的针帽的注射装置。针帽与注射器针头的针套或罩接合,紧抓罩并允许其被移除。帽具有平的底部,允许组装装置直立地支撑在例如工作台上。为了辅助这,帽自装置外壳的平面向外地展开,以提供更大的稳定性。
进一步的包括外壳和罩移除器的注射装置被公开在WO2007/132353(Becton Dickinson France)和GB2437922(Owen Mumford Ltd)中。这些罩移除器也具有向外展开的底部或圈。
发明内容
本发明的目标是提供包括罩式注射器和罩移除机构的装置,该罩移除机构易于使用并是可靠的,减少组装注射装置的失效率并有利于维持无菌状态。
根据本发明的第一方面,提供一种用于加载到注射装置的设备,其包括:注射器,其具有注射器主体、针头和为针头提供无菌盖得罩;罩移除器,该罩移除器具有大体上封闭罩和唇或多个唇的主体,该唇向内突出以接合罩和注射器主体之间的接合部;该罩移除器在其最宽点具有与注射器主体大体上相同或小于注射器主体的外尺寸,其中,设备可通过装置远端处的开口被加载到注射器装置,以便在加载时,罩移除器的一部分突出通过装置的近端以便于用户移除罩移除器和罩。
优选地,罩移除器的突出部具有抓紧构造,以用于帮助用户移除罩移除器和罩。所述的抓紧构造可以是腰部或底割以辅助用户抓紧和/或允许把手被用户所抓住的第二罩移除工具所接合。
在本发明的一个实施例中,罩移除器可被形成为两个大体上相同的具有互补互锁特征的部分,使得相同的部分可置于罩周围并咬合在一起以使唇或多个唇接合所述接合部。
两个大体上相同的部分可铰接地连接在一起。
在本发明的第二实施例中,罩移除器可包括单铸造部件,该铸造部件具有在轴向方向沿所述主体自唇或多个唇延伸的槽,槽按需要尺寸形成以允许罩在横向方向被加载到主体内的开口,使得所述唇或多个唇接合罩和注射器主体之间的接合部。
罩移除器可具有大体上坚硬的材料,例如坚硬的塑性材料。
罩移除器优选地按需要尺寸形成以允许注射器和罩移除器通过注射装置的外壳部分,优选地由远端或非注射端被插入。优选地,注射器是被预填充的。
根据本发明的第二方面,提供一种包括前述权利要求中任一项所述的设备的注射装置,其中,装置进一步包括用于辅助从注射器注射药剂的构件。
罩移除器按需要尺寸制作以具有与注射器主体大约相同的宽度。注射器主体通常是圆柱形的。唇可从所述中空主体的开口端向内地突出,并优选地配置成与接合部接合。抓紧构造或把手可从所述主体轴向地延伸,并可配置成通过注射装置的开口端向外地突出。
优选地,罩移除器按需要尺寸制作以允许注射器和罩移除器通过注射装置的外壳部分的远端(即,非注射)的开口被插入。
将要理解的是,罩移除器便于使罩自注射器移除。设备可配置成装载到注射装置。接合部可以处于注射器主体的近端。外部尺寸优选地是圆柱形主体的直径。用户可通过抓住和拉所述把手从注射器移除罩。
罩移除器的主体优选地是中空的,并且优选地也是圆柱形。如此一来,将要理解的是,相应宽度或直径将转换到相应圆周。因而,罩移除器的中空主体按比例形成以紧贴地装配到罩,并具有与注射器主体大体上相同的直径或圆周。
因此,覆盖罩的中空主体的外表面处于与注射器主体大体上相同的平面。罩移除器可延伸越过接合部(罩和注射器主体的近端之间),使得中空主体和注射器主体大体上平齐。
罩移除器的圆周可沿其长度变化,尤其是在把手处,其在横截面甚至更平或者是椭圆形。然而,罩移除器的外圆周在其最宽的点,与注射器主体的外圆周大体上是相同的。从而它符合最大的外直径,发现沿其(轴向)长度罩移除器大体上与注射器主体的外直径是相同的。
因而优选地是,罩移除器的最大外尺寸或直径是罩和注射器主体的近端之间的接合部处的中空主体的尺寸。
罩移除器在其外尺寸或周长的最宽的点处优选为大于注射器主体的外直径或周长的不大于20%,优选地为不大于15%,优选地为不大于10%,优选地为不大于8%,优选地为不大于6%,优选地为不大于4%,或者甚至为不大于2%。
可被选地,罩移除器在其外尺寸或周长的最宽的点处优选地为小于注射器主体的外直径或周长的不大于20%,优选地为不大于15%,优选地为不大于10%,优选地为不大于8%,优选地为不大于6%,优选地为不大于4%,或者甚至为不大于2%。
对于罩移除器在其尺寸或周长的最宽点处而言,注射器主体的外尺寸或周长的95%-105%的范围尤其是优选的。
将要理解的是,上述讨论的外尺寸或周长也应用到所述部分的相应直径。
优选地,中空主体的最宽点具有与把手相同的外直径,即是共面的。
在另一个方面,本发明提供设备,其包括:预充填注射器,其具有注射器主体、针头和为针头提供无菌盖的罩;罩移除器,其便于罩从注射器的移除;该设备被配置成加载到注射装置,并且罩移除构件包括:用于大体上封闭罩的中空圆柱体;自所述中空主体的开口端向内地突出的唇或多个唇,并且其配置成与罩和注射器主体的近端之间的接合部接合;自所述中空主体轴向地延伸的把手,并且其可配置成向外地突出通过注射装置的开口端;罩移除构件在其最宽点处具有与注射器主体相同的外直径,其中,用户可通过抓住和拉所述把手而从注射器移除罩。
在在一个方面,本发明提供便于从预填充注射器移除罩的设备,罩为注射器的针头提供无菌盖,并且注射器可配置成加载到注射装置,该设备包括:用于大体上封闭罩的中空圆柱形主体;自所述主体的开口端向内地突出的唇或多个唇,并且其配置成与罩和注射器主体的近端之间的接合部接合,该唇或多个唇相对于所述主体实质上是坚硬的;自所述主体轴向地延伸的把手,并且其可配置成向外地突出通过注射装置的开口端;其中,用户可通过抓住和拉所述把手而从注射器移除罩。
附图说明
图1图示了根据本发明第一实施例的设备,该设备在预充填注射器的罩的周围被组装并包括罩移除器;
图2图示了包括图1的设备的注射装置的组装中的中间阶段;
图3图示了图2的注射装置的组装后状态;
图4图示了移除罩移除器的步骤,以及从图3的组装装置捕获罩的步骤;
图5图示了根据本发明第二实施例的设备,该设备在预充填注射器的罩的周围被组装并包括罩移除器;
图6图示了加载预充填注射器之后的图5的设备;以及
图7图示了罩移除器的进一步的实施例。
具体实施方式
WO2007/036676(supra)允许罩和注射器插入到装置的远端或非注射端。然而,它不允许罩移除器在将罩(与注射器和罩移除器)插入到注射装置外壳之前首选与罩接合。这种布置的不足是,在装置开始使用之前,用户不能确定罩移除器是否已经适当地与装置接合。然而,本发明允许罩移除器,例如通过供给者,与罩接合,然后提供给用户。这确保安心和减少所需的组装步骤数。这也具有助于维持设备的无菌状态的优点。
Lee等(US 2007/0167916A1)涉及一种用于安全注射器的外园筒。圆筒由两个半份组成并在无罩存在时用来保护针头。圆筒不能用来移除罩自身。用来防止针头刺痛的安全装置被公开在JP 2000116777A(MitsubishiPencil Co.)中,其包括一块具有适宜凹槽的底板,使得底板能对半折叠以便封闭暴露的针头。GB2414401A(Cilag AG International)提供一种包括外壳的注射装置,该外壳沿一侧敞开。装置试图解决注射装置驱动弹簧对注射器主体上的凸缘引起的损害。
WO2007/047200、WO2007/132353或GB2437922(supra)都不允许罩移除器与罩接合,然后插入到注射装置。这是因为它们的罩移除器在注射装置外壳的直径外向外地伸展。Lee等(US 2007/0167916A1)、JP2000116777A和GB2414401A根本未公开罩移除器。
现在将描述罩移除器,该罩移除器能使覆盖预填充注射器的针头的罩或套可以容易地和可靠地移除。如果上述所概述的那样,注射装置的组装者(例如,自动注射器和类似物)将从供应商获得预填充注射器。应当理解的是,任何注射器可用于当前设备,使得罩移除器因而按规定尺寸制作。
典型的注射器包括容纳药剂的主体、位于主体内并自主体向外延伸的柱塞以及联接到主体的对立端的皮下注射针头。橡胶或塑料罩覆盖针头并密封主体的台肩周围。图1图示了这种具有主体2和罩3的注射器1。在罩3和主体2的远端之间的接合部,存在小的轴向间隙4。
图1也示出了两个大体上相同的罩移除器“半份”5a和5b。每一个半份被铸造成由坚硬塑料材料制成的单片。图1示出了置于注射器罩2的下侧周围的下半份5b。半份的每一个近端具有向内突出的唇6,其延伸在端部的圆周周围。在图1的组装状态,下半份5b的唇6与形成在罩3和注射器末端之间的间隙4接合。在组装期间,上半份5a向下挤压在下半份5b之上,使得一系列凹陷和配合的突出7(沿半份的长度形成)咬合在一起,使罩移除器完全地围绕在罩周围。
图2图示了插入到具有外壳10的注射装置9的外罩8内的注射器1。接合有罩移除器的注射器经由开口12被插入到装置9的非注射端11。应当理解的是,装置13的注射端在组装装置时最接近于针头,设备(罩移除器和罩式注射器)被完成并准备使用。因而,远端/非注射端11是装置的近端/注射端13的对立端。注射装置未以任何详细的细节示出,除了内部机构12。注射器1的罩3的外直径,使得注射器可从套内的开口12插入套内,直到注射器到达某个更低的停止位置。该位置在图3中示出。从图形中能看到,形成在罩3的末端处的把手或把柄14突出通过套的注射端13处的开口15。把手14被底切以助于用户抓紧把手。尽管在图形中未示出,供注射器插入的套的末端11随后被关闭以将注射器紧固在适当位置。
图4图示了在被用户移除盖之后的注射装置,即通过抓紧和拉把手14。针头16然后在此阶段被暴露,即使在激活装置之前,它保持在套内。
图5图示了备选的罩移除器100。注射器1完全等同于上文描述的注射器,并且相同的参考数字被用来识别不同的部件。罩移除器100被形成为单一的模压塑料元件。主体部101通常是圆柱形的,具有中空内空间102。主体的近端103具有开口104。唇105延伸在开口104的圆周周围,其略微地向内延伸。槽106自开口105延伸到大概罩移除器100的中间长度处的一点。在此点,主体101延伸入可能是中空或实心的把手107。把手107轻微地收窄成腰部段108。腰部的外表面具有脊部109以改善用户的抓紧。
应当从图5理解到的是,倘若槽的宽度大于注射器末端和罩之间的接合部的狭窄直径,注射器1的罩3可被挤压通过设定在主体内的槽106,以进入内空间102。在一些情况下,槽的宽度可以略微地小于该直径,以便一旦压入主体,罩(和注射器)被保持在适当位置。然而,一旦注射器和罩移除器被安装在注射装置中,这可能不是必需的,因为注射装置的内部配置防止罩跌出罩移除器外。图6图示了在将罩压入罩移除器之后的注射器。
至于参考图1至图4所描述的设备,通过从装置的非注射端内的装载开口的插入,随后将注射器和罩移除器装载到注射装置。一旦被安装,把手107突出通过装置的注射端开口,允许用户通过抓紧和拉把手107而除去移除器。
图7图示了罩移除器200的进一步的实施例。这类似于图1的设备,除了装置的两个半份201a、201b沿一侧通过一对铰链202可铰接地联接在一起。在组装期间,第一个半份201a布置在注射器主体下方,之后,第二半份201b折叠在第一半份之上,并且咬合在适当位置。突出部7也被示出。
本领域技术人员应当理解的是,在不脱离本发明范围的情况下,可对上文所描述的实施例做出不同的修改。
Claims (7)
1.一种用于加载到注射装置的设备,其包括:
注射器,其具有注射器主体、针头和为针头提供无菌盖的罩;
罩移除器,该罩移除器包括主体以及单个或多个唇,所述罩移除器的主体大体上封闭所述罩,所述单个或多个唇向内突出以接合所述罩和所述注射器主体之间的接合部;该罩移除器在其最宽点具有与注射器主体大体上相同或小于注射器主体的外尺寸,其中,设备可通过注射装置远端处的开口被加载到注射装置,以便在加载时,罩移除器的一部分突出通过注射装置的近端以便于用户移除罩移除器和罩。
2.根据权利要求1所述的设备,其特征在于,罩移除器的突出部具有抓紧构造,以用于帮助用户移除罩移除器和罩。
3.根据权利要求2所述的设备,其特征在于,所述抓紧构造是腰部或底割,所述腰部或底割用于辅助用户抓紧和/或允许把手被用户所抓住的辅助罩移除工具接合。
4.根据前述权利要求中任一项所述的设备,其特征在于,所述罩移除器可被形成为两个大体上相同的具有互补互锁特征的部分,使得相同的部分可置于罩周围并咬合在一起以使单个或多个唇接合所述接合部。
5.根据权利要求4所述的设备,其特征在于,所述两个大体上相同的具有互补互锁特征的部分可铰接地连接在一起。
6.根据前述权利要求1至3中任一项所述的设备,其特征在于,所述罩移除器包括单一的塑料模压元件,该单一的塑料模压元件具有在轴向方向沿所述罩移除器的主体从所述单个或多个唇延伸的槽,所述槽按需要尺寸形成以允许罩在横向方向被加载到所述罩移除器的主体内的开口,使得所述单个或多个唇接合罩和注射器主体之间的接合部。
7.根据权利要求1所述的设备,其特征在于,所述注射装置进一步包括用于辅助药剂从注射器注射的构件。
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2009
- 2009-11-17 WO PCT/GB2009/051557 patent/WO2010055357A1/en active Application Filing
- 2009-11-17 EP EP09756554.3A patent/EP2355874B1/en not_active Not-in-force
- 2009-11-17 CN CN200980152099.4A patent/CN102264419B/zh not_active Expired - Fee Related
- 2009-11-17 JP JP2011543821A patent/JP5559198B2/ja not_active Expired - Fee Related
- 2009-11-17 US US13/129,418 patent/US8998855B2/en not_active Expired - Fee Related
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CN101252962A (zh) * | 2005-09-01 | 2008-08-27 | 欧文蒙福德有限公司 | 针罩组件 |
Also Published As
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EP2355874A1 (en) | 2011-08-17 |
CN102264419A (zh) | 2011-11-30 |
GB2465390A (en) | 2010-05-19 |
GB0820967D0 (en) | 2008-12-24 |
JP2012508634A (ja) | 2012-04-12 |
EP2355874B1 (en) | 2014-10-08 |
US8998855B2 (en) | 2015-04-07 |
WO2010055357A1 (en) | 2010-05-20 |
JP5559198B2 (ja) | 2014-07-23 |
US20120029439A1 (en) | 2012-02-02 |
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