CN101282751B - 具有通气装置的自动注射注射器 - Google Patents

具有通气装置的自动注射注射器 Download PDF

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CN101282751B
CN101282751B CN200680026185.7A CN200680026185A CN101282751B CN 101282751 B CN101282751 B CN 101282751B CN 200680026185 A CN200680026185 A CN 200680026185A CN 101282751 B CN101282751 B CN 101282751B
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retraction assemblies
sealing
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CN101282751A (zh
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理查德·戴维·吉莱斯皮三世
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West Pharmaceutical Services Inc
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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
    • A61M5/20—Automatic syringes, e.g. with automatically actuated piston rod, with automatic needle injection, filling automatically
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    • A61M5/20—Automatic syringes, e.g. with automatically actuated piston rod, with automatic needle injection, filling automatically
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    • A61M5/178—Syringes
    • A61M5/24—Ampoule syringes, i.e. syringes with needle for use in combination with replaceable ampoules or carpules, e.g. automatic
    • A61M5/2455—Ampoule syringes, i.e. syringes with needle for use in combination with replaceable ampoules or carpules, e.g. automatic with sealing means to be broken or opened
    • A61M5/2466—Ampoule syringes, i.e. syringes with needle for use in combination with replaceable ampoules or carpules, e.g. automatic with sealing means to be broken or opened by piercing without internal pressure increase
    • A61M2005/247—Ampoule syringes, i.e. syringes with needle for use in combination with replaceable ampoules or carpules, e.g. automatic with sealing means to be broken or opened by piercing without internal pressure increase with fixed or steady piercing means, e.g. piercing under movement of ampoule
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    • A61M5/31—Details
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    • A61M5/2459—Ampoule syringes, i.e. syringes with needle for use in combination with replaceable ampoules or carpules, e.g. automatic with sealing means to be broken or opened upon internal pressure increase, e.g. pierced or burst
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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
    • A61M5/24—Ampoule syringes, i.e. syringes with needle for use in combination with replaceable ampoules or carpules, e.g. automatic
    • A61M5/2455—Ampoule syringes, i.e. syringes with needle for use in combination with replaceable ampoules or carpules, e.g. automatic with sealing means to be broken or opened
    • A61M5/2466—Ampoule syringes, i.e. syringes with needle for use in combination with replaceable ampoules or carpules, e.g. automatic with sealing means to be broken or opened by piercing without internal pressure increase
    • A—HUMAN NECESSITIES
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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
    • 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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    • 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
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    • A61M5/326—Fully automatic sleeve extension, i.e. in which triggering of the sleeve does not require a deliberate action by the user

Abstract

一种自动注射注射器，该注射器包括注射组件和可操作地固定于注射组件的收缩组件。收缩组件包括：具有针头接口的皮下注射针头；具有下密封的端帽，皮下注射针头的一部分可以穿过该下密封；收缩弹簧，该收缩弹簧被置于针头接口和端帽之间，并且在其间保持在部分压缩的状态；上密封，该上密封通过在针头接口上的收缩弹簧的弹力被推向收缩组件的正面密封表面，从而在上密封和下密封之间定义密封区域；和通气装置，该通气装置与密封区域以流体方式相连通，从而平衡密封区域与收缩组件外部之间的压力。

Description

具有通气装置的自动注射注射器 
技术领域
本发明涉及自动注射注射器。更确切的，涉及具有通气装置的自动注射注射器。 
背景技术
诸如艾滋病(AIDS)，肝炎及其它的疾病正在普通人群中增长。这导致了使用可防止意外针刺伤危险的专门产品的持续趋势。本领域内的许多现有装置包括有自收缩(self-retracting)针头以便减轻意外针刺伤。 
在许多威胁生命的状况下，诸如过敏性休克，以及暴露于化学的、放射性的和生物学的武器时，需要使用自动注射注射器。典型的自动注射注射器允许未经过医务训练的用户通过人工触发自动注射功能而自动注射药物。一些现有的自动注射注射器也包括自收缩针头。 
这种装置在使用前对液体通路部分的消毒及无菌化维护被证明比现有的装置更困难。而且，这种装置的装配已被证明既耗时又昂贵。 
因此，对改进的自动注射注射器存在持续的需求，从而克服、减少或减轻一个或更多上述现有装置的缺点或不足。 
发明内容
本发明的一个目的是提供一种具有通气装置的自动注射注射器。 
本发明的另一个目的是提供一种易于装配的自动注射注射器，其中，在把药剂盒(medicine cartridge)装进注射器之前，针头保持在通气性的消过毒和/或无菌的区域内。 
本发明的另一个目的是提供一种具有注射组件和收缩组件的自动注射注射器。注射和收缩组件可以被用户操作性的彼此连接。收缩组件包括一个在安装注射和收缩组件前被保持在通气性的消过毒和/或无菌的 区域内的针头。 
本发明的另一个目的是提供一种具有注射组件和收缩组件的自动注射注射器。注射和收缩组件可以被用户可操作地彼此连接。收缩组件包括上密封和下密封，从而限定了位于它们之间的消过毒和/或无菌的区域。为了便于安装，上密封在使用前被收缩组件的部分偏移收缩弹簧维持在原地。收缩组件包括用于平衡消过毒和/或无菌的区域与弹簧的外部之间的压力的通气装置。在一些优选实施例中，通气装置为收缩组件的多孔塑料端帽。 
本发明的另一个目的是提供一种用于自动注射注射器的收缩组件。该收缩组件包括上密封和端帽。使用前，上密封被部分偏移的收缩弹簧维持在原地。端帽由多孔塑料材料和可穿透的弹性密封制成，其中，多孔塑料材料允许通气从而防止压力差克服收缩弹簧的弹力，而在触发注射机构时针头元件穿过该可穿透弹性密封。 
从下面的详细描述和附图以及所附权利要求，本发明的上述特征和其它特征以及优点将被本领域技术人员认识和理解。 
附图说明
图1所示为根据本发明的自动注射注射器的例示性实施例的立体图； 
图2所示为图1所示注射器的横截面图； 
图3所示为图1所示注射器的局部分解图； 
图4所示为注射前本发明的收缩组件的例示性实施例的截面图； 
图5所示为在注射中和收缩前，图4所示的收缩组件的截面图。 
具体实施方式
参考附图，尤其是图1-3，示出了根据本发明的自动注射注射器10的例示性实施例。当触发时，注射器10适宜于使皮下注射针头从组件内自动延伸而在注射位置进入肌肉组织内，从而注射单一的、预测量的药品剂量，并且可以在注射完成后自动收缩皮下注射针头而使其回到组件内。 
有益地，注射器10包括一个或多个包括通气装置的密封区域，该通气装置允许这些区域在密封区域和注射器外部环境间平衡压力或通气，从而防止进入密封区域内的污染(例如，微粒，细菌，病毒等)。可以确定，当运输期间暴露于各种环境状况下，通常是当被用户所携带和储存时，本发明的通气装置允许密封区域通气。而且，有益地，通过使用诸如，但不限于，暴露于环氧乙烷(EtO)气体、伽玛射线、蒸汽、干热和其它方法，本发明的通气装置可以允许注射器被消毒。 
注射器10包括注射组件12、药剂盒14、和收缩组件16。因而，注射器10是多组件装置，在需要时用户或健康服务提供者(例如，药剂师、医生、护士等)可以快速和容易地组装。由于注射器10不需要在制造时组装，本发明有效地把药剂盒14的有效期和注射器10的有效期分离开。 
例如，典型的流感疫苗的有效期为一年。尽管相较于在诊所内排队以及在旅途上和去诊所看病的花费，为公众提供一种可以自我预防注射的装置的益处是不言自明的，但是在制造时难以精确预见流感季节的严重度，因而难以预测对装有疫苗的装置的预期需求，因此，如果整个装置是预先装好的，像通常需要其它装置一样包括有药剂盒，并且流感季节的严重度低于预期，则疫苗过期的代价是巨大的，因为整个装置将会报废。相反地，根据本发明，药剂盒14可以与注射器10保持独立直到需求得到确定。因此，用户或健康服务提供者可以保持注射和收缩组件12，16的供应，它们具有长得多的使用寿命，从而仅需替换已过期的药剂盒14。 
在所示的实施例中，注射组件12和收缩组件16可以用卡扣配合方式彼此固定，以便在注射后组件不会彼此分离。例如，注射组件12包括一个或多个径向凸出键(tab)18，其与定义在收缩组件16内的对应数量的开口20以过盈关系相配合。当注射组件12被插入收缩组件16时，键18作用于收缩组件而使管的内部尺寸变形。一旦键18被开口20所接收，收缩组件16的内部尺寸通过自身的回弹返回到其原始尺寸，从而永久地把键固定在开口内。 
当然，注射组件12和收缩组件16以任何其它需要的方式彼此固定 也符合本发明的主旨，并且，优选地，以便在注射后组件不会相互分离。 
在安装好的状态下，注射组件12和收缩组件16在其间定义了密封的或气密的密封。例如，注射组件12包括密封件22，诸如，但是不限于，O型圈。一旦注射组件12和收缩组件16被轴向安装并且固定在一起，密封件22与收缩组件的内部和注射组件的外部相配合，从而在彼其间形成气密的径向密封。在所示实施例中，密封件22被置于定义在收缩组件16内的开口20的内部，从而在键18和开口20之间的卡扣配合连接的下部提供气密封。因此，通过密封件22和收缩/注射组件16、18的相互作用，药剂盒14之外和注射器10之内的区域是彼此气密性密封的。 
通常，注射组件12包括注射弹簧。收缩组件16接收药剂盒14并且包括皮下注射针头和收缩弹簧。当触发注射组件12时，注射组件的弹簧力克服收缩弹簧的弹簧力而把针头在注射位置处插入肌肉组织，并使药筒与针头以流体方式连通，从而从药剂盒处分送药品。一旦药品被注射完毕，注射组件12自动断开与注射弹簧的连接，以便收缩弹簧可以把针头退回到收缩组件16内。 
为了清楚的目的，注射组件12详细的操作没有在这里描述。然而，如图2和图3所示，通过在注射方向26上驱动活塞杆24，注射组件12可以以任何已知的方式操作而从药剂盒14中肌肉、皮下和/或皮内注射药品。例如，注射组件12可以使用在共有的和被转让的第6,387,078号美国专利中所显示和描述的方式操作，并且通过引用将其内容整体并入此处。 
如上所述，注射器10不需要在制造时被安装。注射器10的安装将参考图3进行描述。药剂盒14包括药瓶30、可移动的塞子32、和盖帽(crimp cap)34。帽34包括可刺穿单元36。 
药剂盒14被插入收缩组件16中，以使可移动塞子32相对于注射组件12是最近的，同时盖帽34和可刺穿单元35与收缩组件16的下部相邻接。 
一旦药剂盒14被安装入收缩组件16中，注射和收缩组件能够被可操作地彼此固定。当装配时，活塞杆24位于与塞子32最近处，而帽34 位于与上密封44相接触处(如图4和图5所示)。在安装好的位置，触发注射组件12会促使活塞杆24首先移动药剂盒14，然后在注射方向26上移动塞子32，从而分别插入针头和在药剂盒处把所含的药品排出。 
参考图4和图5描述了收缩组件16。收缩组件16包括收缩弹簧40，双头针42，上密封44，端帽46和下密封48 
上密封44被构造为接收药剂盒14的帽34。上密封44被构造为抵向定义在收缩组件16内的正面密封表面50和/或径向密封表面60形成气密性密封。 
在注射器10被触发之前，收缩弹簧40被维持在针头接口66和端帽46之间的部分压缩位置。在这一位置，收缩弹簧40在与注射方向26相对的方向推进针头接口66而维持上密封44与密封表面50相接触，并因而抵向密封表面50而密封。有益地，收缩组件16可以在制造过程中的一定时间消毒，以便在上密封44和下密封48之间定义消过毒的或无菌的(在下文中称作“消过毒的”)内部区域52。以这种方式，在注射器被触发之前，内部区域52维持针头42处于消过毒的或无菌的状态下。 
可以确定，如果不能调整内部区域52和外部区域54之间的压力差，在某些场合下，压力差可以克服弹簧40的弹力从而使上密封44和密封表面50之间的接触被断开。破坏上密封44和密封表面50之间的接触会危及内部区域52的已消毒或无菌状态。 
例如，收缩组件16(在与注射组件装配之前)在制造、运输或存储期间可被暴露于温度和/或压力变化的环境下。这些环境状况的变化足以导致内部区域52内的压力低于收缩组件的外部区域54的压力。或者，这些环境状况的变化足以导致外部区域54的压力高于内部区域52的压力。内部区域52和外部区域54之间的压力差足以克服弹簧40的弹力，从而断开上密封44和密封表面50之间的接触，和/或导致上密封在注射方向26上的偏移，潜在地可能被针头42的药品入口尖端所刺穿。 
为了克服由于内部区域52和外部区域54之间压力差的变化所带来的不利后果，收缩组件16有益地包括通气装置56。通气装置56使内部区域52与外部区域54以流体方式连通，以便使内部区域可以与外部区 域交换气体。优选地，通气装置56是微生物过滤器，以便内部区域52可以与外部区域54交换气体，同时防止微生物、颗粒、细菌、病毒以及类似物进入而潜在地污染内部区域。通过允许内部区域52和外部区域54之间交换气体，通气装置56确保上密封44与密封表面50保持连接。 
在一个实施例中，端帽46被构造为通气装置56。例如，端帽46可以由热塑性材料制成，该材料具有足够保持内部区域52的压力均衡(下文中称作“通气性”)的多孔性，同时防止污染物(例如，微生物，颗粒，细菌，病毒等)进入内部区域。具有上述通气性和消毒/无菌屏障能力的热塑性材料在乔治亚州Porex Technologies Corporation of Fairburn公司的第6,551,608号美国专利中被公开并描述。 
在这一实施例中，端帽46具有通气装置56的功能。这里，端帽46优选是塑模出或其它方法形成的所需形状的刚性热塑性材料。端帽46把下密封48维持在相对针头42的所要求位置上。例如，端帽46可以与下密封48共同铸模而形成一个整体单元。 
应该理解通过示例的方式描述了注射器在端帽46处具有通气装置。当然，本发明的主旨也包括：与收缩组件的内部区域52和外部区域54以流体方式相连通的收缩组件16的任何部分可以以流体的方式与收缩部件的内部区域52和外部区域54相连通而包括通气装置56。 
有益地，自动注射注射器10包括有透气通气装置56有助于在制造、运输和存储期间维持内部区域52的已消毒和/或无菌状态。 
再次参考图4和图5，针头42是双头皮下注射针头，其包括药品入口尖端62、组织穿透尖头和药品出口尖端64。如图4所示，入口尖端62被置于最接近上密封44处，而出口尖端64被置于最接近下密封48处。 
在使用注射器10期间，活塞杆24的运动推动药剂盒14沿注射方向26向上密封44运动，以便入口尖端62刺穿上密封和药剂盒的可刺穿单元36从而使针头与药剂盒14流体连通。因为药剂盒14内的药物是不可压缩的液体，所以通过抵消收缩弹簧40的弹力，活塞杆24的进一步运动还会通过克服收缩弹簧40的弹力而在注射方向26上推动针头42。因此，出口尖端64刺穿下密封48并被插入注射位置处的肌肉组织。最后， 如图5所示，活塞杆24的运动在注射方向26上推动塞子32，以便药剂盒14内的药品通过出口尖端64被注入用户体内。 
一旦注射组件12完成活塞杆24的运动，活塞杆被注射组件的注射弹簧(未示出)释放，以便收缩弹簧40可以在与注射方向26相反的方向上推动针头42、药剂盒14和活塞杆，直到出口尖端64被缩回收缩组件16的内部区域52内。 
在此实施例中，注射组件12被永久固定于收缩组件16，针头42缩回收缩组件使得注射器10能够防止被针头意外刺伤，因此，可以获得使用的安全性。 
有益地，收缩组件16定义了内部区域52，双头针42被密封在其中。这里，不管环境状况如何变化，双头针42可以通过通气装置56被维持在已消毒或无菌的状态下。 
注射器10可以在定期消毒的工具包(未示出)中处于未组装状态而用于装配和使用。这里，该工具包包括在消毒袋内的注射组件12和收缩组件16。因此，该工具允许用户或医务提供者通过简单打开包、将独立供应的药剂盒14放置在收缩组件16中、并且将注射组件和收缩组件彼此固定而准备好注射器10用于使用。在一些实施例中，该工具包在消毒袋包内包括一个或多个注射位置清洁药签(cleaning swabs)，诸如预先包装好的酒精棉签。在另一些实施例中，该工具包在消毒袋内包括药剂盒14。 
应该注意到，第一、第二、第三、上、下等词在这里被用于修饰各种元件。除非特别说明，这些修饰词并不意味着对修饰元件的空间、先后或内外关系的次序。 
在本发明以一个或多个示例性实施例的方式被描述的同时，本领域内的技术人员应该理解根据本发明所作的各种变化形式以及等同替换也不脱离本发明的的保护范围。而且，在本发明的启发下，以适应于特殊的环境和材料而进行的许多修改也不脱离本发明的的保护范围。因此，本发明并不局限于被作为最佳模式的特殊实施例，本发明包括落入所附权利要求内的所有具体实施方式。 

Claims (20)

1.一种自动注射注射器，包括：
收缩组件，所述收缩组件具有：
被维持在所述收缩组件内的密封区域内的皮下注射针头，和
上密封和下密封，所述上密封和下密封定义了处于其间的所述密封区域，所述上密封通过部分偏移的收缩弹簧与所述收缩组件的一部分维持密封关系；和
通气装置，所述通气装置与所述密封区域流体连通，用于平衡所述密封区域和所述收缩组件的外部之间的压力，其中所述通气装置是微生物过滤器。
2.根据权利要求1所述的注射器，其特征在于，所述注射器还包括与所述收缩组件可操作地连接的注射组件。
3.根据权利要求2所述的注射器，其特征在于，所述注射器还包括被可操作地插入所述收缩组件内的药剂盒。
4.根据权利要求1所述的注射器，其特征在于，所述密封区域是消过毒的。
5.根据权利要求1所述的注射器，其特征在于，所述下密封包括可穿透弹性密封，所述皮下注射针头的一部分可以穿过所述可穿透弹性密封。
6.一种自动注射注射器，包括：
收缩组件，所述收缩组件具有被维持在所述收缩组件内的密封区域内的皮下注射针头；和
通气装置，所述通气装置与所述密封区域流体连通，用于平衡所述密封区域和所述收缩组件的外部之间的压力，其中所述通气装置是微生物过滤器，其中所述通气装置包括多孔塑料端帽。
7.根据权利要求6所述的注射器，其特征在于，所述多孔塑料端帽还包括可穿透弹性密封，所述皮下注射针头的一部分可以穿过所述可穿透弹性密封。
8.根据权利要求6所述的注射器，其特征在于，所述密封区域是消过毒的。
9.根据权利要求6所述的注射器，其特征在于，所述收缩组件包括上密封和下密封，所述上密封和下密封定义了处于其间的所述密封区域，所述上密封通过部分偏移的收缩弹簧与所述收缩组件的一部分维持密封关系。
10.一种自动注射注射器，包括：
注射组件；和
收缩组件，所述收缩组件可操作地固定于所述注射组件，所述收缩组件包括：
皮下注射针头，所述针头具有针头接口；
端帽，所述端帽具有下密封，所述皮下注射针头的一部分可以穿过所述下密封；
收缩弹簧，所述收缩弹簧被布置于所述针头接口和所述端帽之间，并且在所述针头接口和所述端帽之间维持在部分压缩的状态；
上密封，所述上密封通过在所述针头接口上的所述收缩弹簧被推向所述收缩组件的正面密封表面，从而在所述上密封和下密封之间定义密封区域，所述皮下注射针头被置于所述密封区域内；和
通气装置，所述通气装置与所述密封区域以流体方式相连通，用于平衡所述密封区域和所述收缩组件的外部之间的压力，其中所述通气装置是微生物过滤器。
11.根据权利要求10所述的注射器，其特征在于，所述注射器还包括药剂盒，当所述注射和收缩组件彼此固定时，所述药剂盒被收纳在所述注射和收缩组件内。
12.根据权利要求10所述的注射器，其特征在于，所述注射器还包括O型圈构件，当所述收缩组件可操作地固定于所述注射组件时，所述O型圈构件在所述收缩组件和所述注射组件之间形成气密性密封。
13.根据权利要求10所述的注射器，其特征在于，所述端帽包括热塑性材料，所述热塑性材料具有足够的多孔性以满足所述压力平衡，从而使所述端帽为所述通气装置。
14.根据权利要求10所述的注射器，其特征在于，所述密封区域是消过毒的。
15.一种注射工具包，包括：
注射组件；
收缩组件，所述收缩组件与所述注射组件可操作地彼此连接，所述收缩部件组件具有：
被维持在所述收缩组件内的密封区域内的皮下注射针头，
针头接口，所述针头接口固定于所述皮下针头，
端帽，所述端帽具有下密封，所述皮下注射针头的一部分可以穿过所述下密封，
收缩弹簧，所述收缩弹簧被置于所述针头接口和所述端帽之间，并且在所述针头接口和所述端帽之间维持在部分压缩的状态，和
上密封，所述上密封通过在所述针头接口上的所述收缩弹簧的弹力被推向所述收缩组件的正面密封表面，从而在所述上密封和下密封之间定义所述密封区域；和
通气装置，所述通气装置与所述密封区域以流体方式相连通，用于平衡所述密封区域与所述收缩组件外部之间的压力，其中所述通气装置是微生物过滤器。
16.根据权利要求15所述的注射工具包，其特征在于，所述注射工具包还包括药剂盒，当所述注射和收缩组件彼此固定时，所述药剂盒被收纳在所述注射和收缩组件内。
17.根据权利要求15所述的注射工具包，其特征在于，所述注射工具包还包括至少一个注射位置清洁药签。
18.根据权利要求15所述的注射工具包，其特征在于，所述注射工具包还包括橡胶绷带。
19.根据权利要求16所述的注射工具包，其特征在于，所述注射工具包还包括包含有所述注射和收缩组件的袋。
20.根据权利要求19所述的注射工具包，其特征在于，所述袋是定期消毒的。
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US20070078394A1 (en) 2007-04-05
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EP1904125B1 (en) 2018-10-17
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