CN113101461A - 用于封闭注射系统的端帽组件 - Google Patents
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Abstract
本发明涉及一种用于关闭注射器系统(10)远端伸出头部(13)的流体通道(14)的端帽组件(30),所述端帽组件(30)包括:‑弹性内帽(50),具有向近端延伸的截头锥形突出部(54),所述截头锥形突出部具有近端面(55),以及‑刚性外帽(40),其牢固地或可牢固地布置在所述弹性内帽(50)的周围;截头锥形突出部和的近端面(55)的直径至少大于注射器系统(10)流体通道(14)的直径。本发明进一步涉及包括这种端帽组件的注射系统。
Description
本发明专利申请是申请日为2014年10月15日、申请号为
201410857906.5、发明名称为“用于封闭注射系统的端帽组件”的发明专利申请的分案申请。
技术领域
本发明一般涉及一种例如注射器的注射系统,以及紧密封闭注射系统远端头部的端帽组件。
背景技术
在本申请中,关于将与组件或装置一起使用的注射系统,所述组件或装置的远端必须理解为离用户的手最远的一端,近端必须理解为离用户的手最近的一端。这样,在本申请中,远端方向必须理解为注射系统的注射方向,而近端方向是相反的方向,即朝向用户手的方向。
现代医学使用各种各样的注射系统来将流体输送到病人体内。例如,这些注射系统可以包括自动注射器、医疗笔或注射器。传统的注射器由于其普遍性、使用简单及成本低而广泛使用。它们通常包括一个纵向的筒,具有开放的近端和包含远端伸出头部的基本封闭的远端。将被注射的流体可以储存在注射筒中,在这种情况下,开放的近端通过塞子封闭,所述塞子在筒内液密地滑动配合,并由柱塞杆驱动。头部具有贯穿其中延伸的流体通道,从而当远端压力施加到柱塞上时允许注射流体。头部可以具有附接的针头或者是鲁尔型的,也就是没有针头的。注射筒通常由玻璃或塑料制成。玻璃由于其化学中性并且低透气性而优选,而塑料由于其抗震动而优选。
几乎所有的液体都可以使用注射器注射。例如,液体可以是药物溶液,例如药物、疫苗、维生素或饮用矿物质。注射器也用于注射诊断溶液、美容液体,包括例如透明质酸或硅树脂成分的凝胶。注射根据应用可以在人体的各个部位进行,包括皮肤、真皮、肌肉和静脉。
通常,提供的注射器是空的,在注射之前立刻充满液体,但是现在越来越多的注射器预充装有要注射的液体以便随时使用,具有多个优点。首先,预充装的注射器减少了需要执行注射的步骤的数量,这在急诊中是尤其宝贵的。其次,预充装的注射器降低了在要注射的液体的数量或质量上人为错误造成的风险。确实,服用错误剂量或不需要的药物可能会妨碍医疗效果甚至导致受治疗患者的死亡或严重伤害。再次,预充装的注射器降低了将液体从多剂量药剂瓶输送到空的注射器导致的污染的风险,这种污染也会导致妨碍医疗效果。最后,预充装的注射器尤其适用于储存难以运输的流体。例如,使用粘性液体或凝胶用于美容用途,或使用药物成分用于麻醉用途,这种注射器是合适的。
在充装注射器及使用过程中,没有针头的注射器配备有端帽来封闭向远端延伸的尖端。事实上,由于流体在预充装注射器中长时间储存,通常在注射前6到18个月,在这个时期内注射器系统必须保持完全密封。端帽和注射器之间的密封质量是非常重要的,因为一个有缺陷的密封会损害流体的性质或纯度,根据储存在注射器中的药物成分的性质会导致有价值液体的浪费、对病人潜在的不可接受的风险以及对医护人员潜在的不可接受的风险。
此外,注射器应当在需要时能容易打开并且无需过度费力即可移除端帽。但众所周知当端帽插入注射器头部时会发生粘滞现象。确实已经观察到当两种材料挤压到一起一段时间后,会发生这种粘滞现象,阻止快速简单地打开预充装注射器。结果,难以打开的端帽会导致预充装的注射器在使用前废弃,并构成不可接受的经济损失。这也可能会导致需要即刻注射的病人死亡或严重损害。
最后,注射器头部的外表面需要远离污染物,例如灰尘或微生物,其可以从头部迁移到流体通道内。确实,如果这些污染物随药物流体注射到病人体内,会触发不适宜的免疫反应,降低治疗效果并削弱病人对治疗的信任。
发明内容
因此,本发明的一个目的就是提供一种确保对注射器头部改善性且长久性密封的端帽。本发明的还一个目的是提供一种能够容易从注射器头部脱开的端帽。本发明的另一个目的是在储存过程中保持注射器头部无菌。
本发明的第一个方面是用于关闭注射器系统远端伸出头部的流体通道的端帽组件,所述端帽组件包括:
-弹性内帽,具有近端延伸的截头锥形突出部,所述截头锥形突出部具有近端面,以及
-刚性外帽,其位于或可以牢固布置在所述弹性内帽的周围,截头锥形突出部的近端面的直径至少大于注射器系统流体通道的直径。
由于弹性内帽的截头锥形突出,所述弹性内帽和远端伸出头部的接触被限定到所述头部的小的远端表面上。确实,弹性内帽的近端面基本垂直于截头锥形突出衍生出的锥形的旋转轴。近端面的表面可以是平坦的也可以显示轻微的曲率半径,其中心位于所述旋转轴线。而且弹性内帽的截头锥形突出的近端面的直径至少大于流体通道的直径,不允许截头锥形突出穿过远端伸出头部的流体通道。这极大减少或避免了长时间储存后可能发生的粘滞现象,因此能够快速简单地将端帽组件从注射系统移除。截头锥形突出的近端面可以是弹性内帽的最近端面。
例如,弹性内帽整体上是圆柱形的,刚性外帽整体上是管形的,在其远端具有横向壁。例如,弹性内帽收纳在刚性外帽中使得弹性内帽的外壁与刚性外帽的内壁至少局部接触,尤其是与刚性外帽的管状部分的内壁相接触。弹性内帽可以通过摩擦收纳在刚性外帽内。
由于它的弹性性质,弹性内帽具有在承受压力时变形的能力,例如当施加远端压力时。例如,弹性内帽整体上是圆柱形时,它在例如远端压力或近端压力的纵向压力的影响下,会发生径向向外的变形。
在本发明的实施方式中,端帽组件具有应力限制机构,当组件关闭所述通道时,例如当远端压力通过注射器头部施加到弹性内帽时,允许弹性内帽大致变形。尤其是,即使弹性内帽收纳于刚性外帽中,应力限制机构允许弹性内帽的至少一部分径向向外变形。弹性内帽的变形确保流体通道和注射器头部的最佳密封。然而,经过长时间保存后,刚性外帽由于弹性内帽转移的应力也会变形,这种变形的刚性帽会导致密封不足。应力限制机构通过限制弹性内帽关闭所述通道时而发生变形转移到刚性外帽的应力的大小,例如施加到弹性内帽的远端压力,来避免刚性外帽不需要的变形,有利于维持长时间内的有效密封。
在本发明的实施方式中,这些应力限制机构包括至少一个窗口,更优选是在所述刚性外帽上的两个径向相对的纵向窗口。例如,窗口设置在刚性外帽的管状壁上。这些窗口适应于弹性内帽的弹性材料,导致通过关闭流体通道和将弹性帽插入刚性外帽产生的变形,例如当弹性帽的直径大于刚性帽的内径时导致变形。尤其是,窗口允许弹性内帽径向向外变形。尤其是,当位于刚性外帽的管状壁时,窗口收纳径向向外变形的弹性内帽的一些部分。
在实施方式中,这些应力限制机构还包括设置在所述刚性外帽的远端开口,来适应当端帽组件关闭所述流体通道时弹性内帽的远端变形,例如当弹性内帽承受远端压力时。远端开口可以设置在刚性外帽的远端横向壁中。
在本发明的实施方式中,弹性帽和刚性外帽包括将所述弹性内帽固定在刚性外帽的保持机构。
在本发明的实施方式中,所述保持机构包括设置在刚性外帽内的肩部和弹性内帽上的径向边缘,弹性内帽通过远端边缘与所述肩部接触而在近端被阻断。因此肩部和径向边缘形成近端阻断机构用来阻断弹性内帽相对于刚性外帽在近端的移动。
在本发明的实施方式中,所述保持机构进一步包括设置在刚性外帽内的至少一个抵接表面,和弹性内帽上的远端面,所述弹性内帽通过抵接表面与远端面接触而在远端被阻断。因此抵接表面与远端面形成远端阻断机构用来阻断弹性内帽相对于刚性外帽在远端的移动。
肩部、径向边缘、抵接表面和远端面一起形成弹性内帽相对于刚性外帽在近端和远端转移的阻断机构。
在本发明的实施方式中,刚性外帽的抵接表面和肩部之间限定的长度L1大于所述弹性内帽的远端面和径向外缘之间限定的长度L2,L1和L2沿端帽组件的纵向轴线测量。因此在刚性外帽和弹性内帽之间留有间隙:该间隙的存在简化了端帽组件的组装,并允许有效持久的密封,即使是用非标准注射器时。
本发明的第二个方面是包括纵向筒、远端伸出头部的注射系统,远端伸出头部具有贯穿其中的流体通道、远端表面和侧面,其中注射系统进一步包括根据本发明第一方面的端帽组件。
本发明的第三个方面是包括具有远端伸出头部的纵向筒和端帽组件的注射系统,所述远端伸出头部具有贯穿其中的流体通道、远端表面和侧面,所述端帽组件包括含有截头锥形突出的弹性内帽和可以牢固布置在所述弹性内帽的周围的刚性外帽,所述组件被配置为当所述端帽组件关闭所述通道时,所述截头锥形突出只有在远端表面接触所述远端伸出头部。
在本发明的实施方式中,刚性外帽具有无菌外罩,当所述组件关闭所述流体通道时用来在周边密封所述远端伸出头部的侧面。无菌外罩保持储存过程中注射器远端头部的无菌性,并由此保持注射器系统的成分的无菌性。
在本发明的实施方式中,无菌外罩进一步具有至少一个环形凸脊。例如,环形凸脊设置在无菌外罩的内壁上。该至少一个环形凸脊增强了无菌外罩和远端伸出头部的侧面之间的密封效果。
在本发明的实施方式中,注射系统具有牢固配合于所述远端头部周围的外缘,具有内螺纹和远端边缘,其中所述刚性外帽具有外螺纹,其能够与外缘的螺纹配合来关闭所述通道。
在本发明的实施方式中,刚性外帽具有当所述端帽组件关闭所述通道时与外缘的远端边缘接触的近端抵接表面。
本发明的第四个方面是用于关闭注射系统的远端伸出头部的流体通道的端帽组件。端帽组件包括具有远端部分和近端部分的弹性内帽和适合牢固布置在所述弹性内帽的周围的刚性外帽。弹性内帽的近端部分包括截头锥形突出和直径大于注射系统的流体通道的直径的近端面。
在本发明的实施方式中,端帽组件还包括应力限制机构,当组件关闭流体通道时,来适应弹性内帽的变形。应力限制机构可以包括刚性外帽中的至少一个窗口,优选是两个径向相对的纵向窗口。可替代的或附加地,应力限制机构可包括刚性外帽中的远端开口。
在本发明的实施方式中,弹性帽和刚性外帽每个均包含至少一个配合表面,其中弹性内帽的配合表面与刚性外帽的配合表面的接触确保弹性内帽固定于刚性外帽中。刚性外帽的配合表面可以包括肩部,弹性内帽的配合表面可以包括径向边缘,其中至少当一个近端压力施加于弹性内帽时,径向边缘接触肩部。可替代地或附加地,刚性外帽的配合表面可以包括至少一个抵接表面,弹性内帽的配合表面可以包括远端面,其中至少当一个远端压力施加于弹性内帽时,至少一个抵接表面与远端面接触。在一个实施方式中,其中刚性外帽包括含有肩部的第一配合表面和含有抵接表面的第二配合表面,以及弹性内帽包括含有径向边缘的第一配合表面和含有远端表面的第二配合表面,刚性外帽的抵接表面和肩部之间限定的长度L1可以大于所述弹性内帽的远端表面和径向边缘之间限定的长度L2。
在本发明的实施方式中,刚性外帽可以包括远端部分、中间部分和近端部分。至少一个应力限制机构,优选纵向窗口,可以位于刚性外帽的远端部分中,近端部分可以具有截头锥形。刚性外帽可进一步包括内部和/或外部增强机构。该增强机构可以是纵向肋或周围的肋。
在本发明的实施方式中,弹性内帽可以包括远端部分和近端部分。远端部分可以基本是圆柱形的,并具有平坦的远端面,近端部分可包括截头锥形突出。近端部分的直径可小于远端部分的直径。弹性内帽的近端部分也可以包括环形隆起。
在本发明的实施方式中,弹性帽可以采取三种不同的构造:一种不与刚性帽组装的自由构造,组装进刚性帽形成端帽组件的第一种加压构造以及当端帽组件关闭注射系统的流体通道时由远端伸出头部施加远端压力的第二种加压构造。
在第二种加压构造中,弹性内帽的远端收纳于刚性外帽的远端部分,弹性内帽的近端部分收纳于刚性外帽的中间部分。弹性内帽远端部分的外径可以大于刚性外帽远端部分的内径,和/或弹性内帽近端部分的外径可以大于刚性外帽中间部分的内径,以为增强刚性外帽和弹性内帽的配合表面的接触。
在第三种加压构造中,弹性内帽在刚性内帽和注射系统的远端伸出头部之间进一步挤压。
在第二种和第三种加压构造中,应力限制机构的作用为减少由于弹性内帽挤压造成的施加在刚性外帽上的应力。
本发明的第五个方面是包括纵向筒、远端伸出头部的注射系统,该远端伸出头部具有贯穿其中的流体通道、远端表面和侧面,其中注射系统进一步包括如上所述的端帽组件。
在本发明的实施方式中,当端帽组件关闭流体通道时,截头锥形突出只接触远端伸出头部的远端表面。
在本发明的实施方式中,刚性外帽还可包括无菌外罩,当端帽组件关闭通道时在所述远端伸出头部的侧面和刚性外帽之间提供周向密封。无菌外罩可包括至少一个环形凸脊。
在本发明的实施方式中,注射系统可进一步包括牢固配合于所述远端头部周围的颈圈。颈圈可以具有内螺纹和远端边缘。在本实施方式中,刚性外帽包括外螺纹能够与颈圈的内螺纹配合来关闭所述通道。当所述端帽组件关闭所述通道时,刚性外帽还可包括与颈圈的远端边缘接触的近端抵接表面。近端抵接表面和颈圈的远端边缘的配合防止头部相对于注射系统旋转运动,避免损伤端帽组件,确保端帽相对于颈圈正确放置,提示用户已经密封好。
本发明的第六个方面是一种注射系统,其包括纵向筒、远端伸出头部和具有内螺纹的颈圈。颈圈牢固配合于远端伸出头部周围,远端伸出头部具有侧面和贯穿其中的流体通道。注射系统进一步包括含有弹性内帽和牢固地或可以牢固地布置在所述弹性内帽的周围的刚性外帽的端帽组件。端帽组件的刚性外帽包括将与颈圈的内螺纹一起拧紧的外螺纹、截头锥形延伸部以及外螺纹和截头锥形延伸部之间的径向凹槽。当端帽组件关闭伸出头部的通道时,截头锥形延伸部将确保远端伸出头部在侧面环状密封以充当无菌外罩。
在本发明的实施方式中,刚性外帽的截头锥形延伸部可以具有至少一个环形凸脊,优选是三个。
本发明的第七个方面是用于封闭注射系统的远端伸出头部的流体通道的端帽组件。端帽组件包括弹性内帽,其具有远端面、径向边缘和限定远端面和径向边缘之间距离的长度L2。端帽组件进一步包括刚性外帽,其牢固地或可以牢固地布置在所述弹性内帽的周围,具有肩部、至少一个抵接表面和限定至少一个抵接表面和肩部之间距离的长度L1。弹性内帽在远端由于远端面和至少一个抵接表面相接触而阻断,在近端由于径向边缘和肩部相接触而阻断。长度L1大于L2,以允许弹性内帽在刚性外帽内的有限移动。
附图说明
现在基于下述描述和附图来更详细阐述本发明,其中:
图1A、1B和1C分别是没有端帽的注射器的侧视图、透视图和截面图。
图2A、2B和2C分别是由本发明一个实施方式的端帽组件封闭的图1A,1B和1C中的注射器的侧视图、透视图和截面图。
图3A、3B、3C、3D和3E分别是图2A和2B中端帽组件的刚性外帽的侧视图、两个截面侧视图、透视图和截面透视图。
图4A和4B分别是图2A和2B中端帽组件的弹性内帽的侧视图和透视图。
图5是图3A、3B和3C的刚性外帽在图4A和4B的弹性内帽的理论叠置。
图6A和6B是根据本发明一个实施方式的端帽组件的横截面图。
图7是安装到图1A、1B和1C的注射器上的端帽组件的横截面图。
图8和9是由本发明另两个实施方式的端帽组件密闭的图1A-C中的注射器的透视图。
具体实施方式
为便于此后描述,术语“上”、“下”、“右”、“左”、“竖直”、“水平”、“顶”、“底”、“横向”、“纵向”及其派生应该按在附图中的朝向联系到本发明。
图1A-1C显示根据本发明一个实施方式的以鲁尔注射器形式的注射系统10。本发明可以与任何其他形式的注射系统一起使用,例如笔或输注系统,只要其具有远端伸出头部。为了清楚起见,本发明只描述鲁尔注射器10。注射器10包含具有纵轴A的纵向筒11、近端凸缘12和远端伸出头部13。远端伸出头部13包括贯穿其中延伸的流体通道14、远端表面15和基本为管状的侧面16(参见图1C)。颈圈(外缘)20例如通过夹持、旋拧或焊接牢固地连接于头部13周围。在另一个实施方式中(未显示),颈圈20与纵向筒模制在一起,与其形成单一部件。颈圈20具有内螺纹21和远端缘22。注射器10进一步包括塞子和柱塞杆,并未显示在图1A-1C中。
如图2A-2C中所示,注射器10可以由端帽组件30密封封闭。端帽组件30包括收纳弹性内帽50的刚性外帽40。
现在参照图3A-3E描述刚性外帽40。
刚性外帽40包括具有纵轴A’的基本管状的壁41,并限定远端和近端都开口的腔41a。管状壁41包括三个不同的部分:远端部分42、中间部分43和近端部分44。
远端部分42具有基本管状的形状,包括一个远端开口42a和两个纵向窗口42b(参见图3E,在图3A和3B中只有一个可见),如示例中所示,径向相对。每个窗口42b在外侧由两个纵向肋42c和一个远端径向肋42d围绕,在内侧由两个抵接表面42e和一个肩部42f围绕。在其它实施方式中(未显示),在刚性帽40中设置有一个、三个或四个抵接表面42e。在抵接表面42e和肩部42f之间限定沿轴A’测量的长度L1,构成纵向窗口42b的纵向尺寸。肩部42f位于远端部分42和中间部分43之间。在其它实施方式(未显示)中,远端部分42包括一个、三个或四个窗口42b。
中间部分43具有大体管状的形状,在内侧包括多个连接于一个肩部43b的纵向边缘43a。在外侧,包含近端抵接表面43d的环43c与两个纵向肋43e和纵向肋42c相连。纵向肋43e只沿着中间部分43的局部延伸,而围绕窗口42b的纵向肋42c,沿着远端部分42和中间部分43局部延伸。肩部43b位于中间部分43和近端部分44之间。
近端部分44具有截头圆锥形或截头锥形延伸部44a。截头锥形延伸部44a包括一个近端开口44b和三个环形凸脊44c。在外侧,外螺纹44d从中间部分43的环43c延伸,并通过径向凹槽44e与截头锥形延伸部44a分离。在另一实施方式(未显示)中,刚性端帽40不具有外螺纹44d,近段部分44只包含具有凸脊44c的截头锥形延伸部44a。这个实施方式可以与没有颈圈20的注射器10一起使用。
刚性外帽可以由刚性聚合物例如聚丙烯、聚乙烯、聚氯乙烯、聚苯乙烯、聚碳酸酯或共聚物例如丙烯腈丁二烯苯乙烯或苯乙烯丙烯腈制得。
现在参照图4A和4B描述弹性内帽50。它包括均具有纵向轴线A”的远端部分51和近端部分52。远端部分51具有基本为柱形的形状和平坦的远端面53。近端部分52包含具有截锥形形状的截头锥形突出部(突出)54、大体与轴线A”垂直的近端面55和环形隆起56。近端部分52的平均直径比远端部分51小,径向边缘57位于近端部分52和远端部分51的连接处。形成截头锥形突出部54的截锥形的锥角α相对于轴线A”优选为40°到60°,更优选为相对于轴线A”50°。沿轴线A”测量的远端部分51的长度L2由径向边缘57和平坦的远端表面53限定。在图4A和4B的实施方式中,近端面55基本是平坦的。在其它实施方式(未显示)中,近端面55具有曲率半径,其中心位于轴线A”处。近端面55的直径优选大于远端头部13的流体通道14的直径。从图4A和4B可以看出,近端面55是弹性内帽50的最近端面。
弹性帽50能够采取三种不同的构造:一种不与刚性帽40组装的自由构造,组装进刚性帽40形成端帽组件30的第一种加压构造以及当端帽组件30关闭注射系统10的流体通道14时由于远端伸出头部13施加远端压力的第二种加压构造,随后进行解释。
本发明弹性帽50的合适的材料包括天然橡胶、丙烯酸-丁二烯橡胶、顺式-聚丁二烯、氯或溴橡胶、聚氯乙烯弹性体、聚烷撑氧聚合物、乙烯基醋酸乙烯、氟化硅橡胶、十六氟苯乙烯-亚乙烯基氟-四氟乙烯四聚物、丁基橡胶、聚异丁烯、合成聚异戊二烯橡胶、硅胶、苯乙烯-丁二烯橡胶、四氟乙烯丙烯共聚物、热塑性-共聚酯、热塑性-弹性体等及其合成物。
弹性内帽50(图4A-4B)和刚性外帽40(图3A-3E)的横截面图的叠合体在图5中作为理论图示出,由于在本图中弹性内帽50的示意性形状是自由构造的,因此与刚性外帽40的形状重叠(在环状隆起56处)。弹性内帽50的远端部分51将收纳于刚性外帽40的远端部分42,弹性内帽50的近端部分52将收纳于刚性外帽40的中间部分43。在图5的理论图中,刚性外帽40的轴线A’与弹性内帽50的轴线A”重合,在抵接表面42e和肩部42f之间的长度L1略大于弹性内帽50远端部分51的长度L2。在另一实施方式中(图7所示),长度L1与远端部分51的长度L2相等。在最后一个实施方式(未示出)中,相比于长度L2,长度L1稍短。最后,弹性内帽50的环状隆起56的直径略大于刚性帽40中间部分43的内径。
图6A和6B示出了准备使用的端帽组件30,其中弹性内帽50已组装在刚性帽40中。弹性内帽50保持在刚性帽40内部,并处于第一种加压构造:它的远端部分51围绕在刚性帽40的抵接表面42e和肩部42f之间,并且它的纵向轴线A”和刚性帽40的纵向轴线A’重合。弹性内帽50在远端由于远端表面53和刚性帽40的抵接表面42e相接触而阻断,在近端由于径向边缘57和刚性帽40的肩部42f相接触而阻断。在图6A和6B的实施方式中,长度L1大于长度L2,在刚性帽40和弹性帽50之间存在间隙G,其允许弹性帽50在刚性帽40内的有限移动。在L1等于或小于L2的实施方式中,刚性帽40的抵接表面42e与弹性内帽50的远端表面53直接接触,同时刚性帽40的肩部42f与弹性帽50的径向边缘57接触。结果,至少当一个近端压力施加于弹性内帽50时,径向边缘57与肩部42f接触,至少当一个远端压力施加于弹性内帽50时,抵接表面42e与远端表面53接触。因此,刚性帽40的抵接表面42e和肩部42f和远端表面53及径向边缘57一起构成将弹性内帽50牢固地固定于刚性帽40的保持装置。
进一步,弹性内帽50的远端部分51的平均直径选择为稍大于刚性帽40远端部分42的内径。这样,在组装后弹性内帽50在直径上紧固,轻微变形,弹性内帽50的一部分甚至穿过刚性帽40的窗口42b(如图7中所示)。这种变形因此增大了抵接表面42e和弹性内帽50的远端面53的接触面积。同样地,如图5所示,近端部分52的环形隆起56具有比刚性帽40的中间部分43的内径稍大的直径。结果,近端部分52在整个直径上紧固,截头锥形突出54在其长度上发生变形,因此进一步朝向刚性帽40的近端部分44延伸。这些变形进一步有利于使弹性内帽50保持在刚性帽40中。在L1小于L2的实施方式(未显示)中,弹性帽50的远端部分51在其长度上紧固并轻微变形。
由于刚性帽40和弹性内帽50的特殊形状,端帽组件30可以通过将刚性帽40的轴A’和弹性内帽50的轴A”相对齐、使弹性内帽50的近端部分52面对刚性帽40的远端开口42a来获得。施加在弹性内帽50上的近端压力或施加在刚性帽40的远端压力允许弹性内帽50进入刚性帽40并轻微变形。这操作可以通过润滑弹性内帽50、润滑刚性帽40的腔41a、或两者来进行辅助。在L1大于L2的实施方式中,间隙G允许弹性帽50更大的变形,且允许更大的制造公差范围,从而使得组装更简单。因此本实施方式的端帽组件30能够较快组装,并且错误组装的概率也有限。
如图7所示,端帽组件30已经准备和注射器10相连。端帽组件的轴A’、A”和注射器10的轴A对齐,端帽组件30的近端开口44b正对注射器10的远端伸出头部13。当端帽组件30具有外螺纹44d时,需要旋转动作将外螺纹44d拧到注射器10的外缘20的内螺纹21上。在旋转结束前,伸出头部13与弹性内帽50的近端面55相接触。在L1大于L2的实施方式中,弹性帽50被推向刚性帽40的抵接表面42e并进一步挤压。在L1等于或小于L2的实施方式中,弹性帽50已经固定于刚性帽40内,并由伸出头部13直接挤压。此后,伸出头部13的侧面16与截头锥形延伸部44a接触,其进一步在径向上向外变形。在旋转结束时,端帽组件30的近端抵接表面43d与外缘20的远端缘22相接触。因此,如图2A、2B和7所示端帽组件30固定于外缘20,并固定于远端伸出头部13。刚性帽40的近端抵接表面43d与外缘20的远端缘22共同合作阻止任何可能会损害端帽组件30的进一步的旋转动作。这种合作也确保端帽30相对于外缘20正确放置,并提供给用户一种触觉提示-注射器10已密封。在另一个实施方式(未显示)中,近端抵接表面43d并不在环43c上,但集成在刚性帽40的外表面上。
在一个实施方式中,注射器10不具有外缘20,并且端帽组件30相应地不具有外螺纹44d或环43c(未显示),端帽组件30仅通过近端移动安装到远端伸出头部13上。
如图7所示,由于近端面55的直径至少大于流体通道14的直径,弹性内帽50实质上并不穿过流体通道14。当端帽组件30插到头部时,弹性内帽50在远端伸出头部13和刚性帽40的抵接表面42e之间受到挤压,其使弹性内帽50的近端部分52发生严重变形以确保紧密密封流体通道14。该变形的一部分被弹性帽50的截头锥形突出54的特定形状所吸收,有利于限制转移到刚性帽40的轴向和径向的应力。如图7所示,弹性帽50的变形一部分也归因于刚性帽40的远端开口42a和纵向窗口42b,通过抵接表面42e进一步降低转移到刚性帽40的轴向应力的量。因此当端帽组件30关闭注射器10的通道14时,弹性内帽50的截头锥形突出54以及刚性帽40的远端开口42a和纵向窗口42b构成使得弹性帽50发生充分变形的应力限制机构。由于应力导致弹性帽50随着时间的压缩,因此避免了刚性帽40尤其是远端部分42发生不需要的变形:注射器在储存时期内完整密封保存。多亏端帽组件与伸出头部13的恰当连接,储存在注射器里的流体的性质或质量,例如纯度,都不会发生改变,甚至在贮存的延长期内也不会发生改变。因此可以避免浪费宝贵的流体以及对与流体接触的病人和医护人员的不可接受的风险。因此,刚性帽40尤其是远端开口42a、窗口42b、抵接表面42e的特殊几何形状,以及弹性内帽50尤其是截头锥形突出54的特殊几何形状使得注射器10的伸出头部13能够长久的密封。
刚性帽40在其外侧通过纵向肋43e、纵向肋42c和远端径向肋42d,在其内侧通过纵向边缘43a和肩部43b增强强度,以抵制当端帽组件30关闭流体通道14时弹性内帽50、或操作端帽组件时用户转移应力导致的任何变形。因此纵向肋43e、纵向肋42c、远端径向肋42d、纵向边缘43a和肩部43b构成增强机构。
在L1大于L2的实施方式中,刚性帽40和弹性帽50之间的间隙G也用于能够兼容不同类型的具有非传统长度的远端伸出头部13的注射器,例如没有按照通用标准设计的注射器。结果即使是在非标准注射器的情形下,根据该特定实施方式的端帽组件30也能够提供持久的最佳密封。
在图7所示的关闭位置下,径向凹槽44e使得截头锥形延伸部44a在径向上只能发生有限变形,由于其与远端伸出头部13的侧面16接触。结果,截头锥形延伸部44a环绕并密封远端伸出头部13,三个环形凸脊44c与侧面16紧密接触。这确保远端头部13的侧壁16圆周密封,能够保持端帽组件30的腔41a无菌,并进一步注射器10的伸出头部13无菌。除此之外,即使在远端头部13不是完美环形时,远端头部13的侧壁16也能圆周密封。当远端头部13不十分对称或具有椭圆部分导致制造公差时,不会损害端帽组件30的腔41a的无菌性。因此在预充装注射器的储存时期内,截头锥形延伸部44a充当无菌外罩,在给病人注射时或注射之前,极大限制或降低了污染物从注射头进入到流体。在其他实施方式(未显示)中,无菌外罩44a具有至少一个环形凸脊44c。
在储存结束时,在将储存的流体注射给病人之前,需要很小的力从外缘20拧开端帽组件30从而打开注射器10的流体通道14。确实,端帽组件30的截头锥形突出54的特定形状限制了弹性帽50和远端伸出头部13到远端表面15的接触面积,因此能够避免弹性内帽50和远端伸出头部13的侧面16或流体通道14的接触。这极大减少或避免了长时间储存后可能发生的粘滞现象,因此能够快速简单地移除端帽组件30。由于截头锥形突出54不直接接触流体通道14的内表面,流体通道14也能够保持颗粒清洁。在打开注射器10时,弹性内帽50的截头锥形突出54也对端帽组件30产生弹性效果,进一步有利于容易移除。最后增强机构43e、42c、42d、43a和43b也使得刚性帽40的管壁41更薄。因此在移除过程中可以限制刚性帽40的变形,又确保了容易移除。根据本发明的端帽组件通过防止预充装注射器使用前的废弃来降低经济损失。进一步,注射可以在紧急情况下实施,不需要很费力。这可以拯救需要即刻治疗的病人。
在图8所示的另一个实施方式中,端帽组件100具有椭圆圆柱的整体形状,刚性帽140的外表面上包括椭圆形增强凸脊141和142,刚性帽140的近端部分(不可见)基本是圆柱形的,与注射器外缘20相匹配,其他结构与之前描述的图1-7所示的端帽组件30的相似。相比于环形圆柱的端帽组件30,端帽组件100更容易旋拧或从注射器外缘20移除,因为椭圆形状提供了与用户手指更多的接触面积,导致更好的把持性。
在图9所示的另一个实施方式中,端帽组件200整体上具有椭圆圆柱的形状,刚性帽240的外表面上具有围绕窗口242(在图9中只有一个可见)的纵向增强凸脊241,在窗口242之间有两个平坦表面243。刚性帽240的近端部分(不可见)基本是圆柱形的,与注射器外缘20相匹配,其他结构与之前描述的图1-7所示的端帽组件30的相似。相比于环形圆柱的端帽组件30,端帽组件200更容易旋拧或从注射器外缘20移除,因为椭圆形状提供了与用户手指更多的接触表面,导致更好的把持性。
在其他实施方式(未显示)中,端帽组件30可以具有篡改证据的结构,例如在外缘20和刚性帽40的环43c之间的可断凸起。在其他实施方式(未显示)中,篡改证据的结构也包括外缘20上的安全环。
由于它的独特结构,根据本发明的端帽组件使得能够长时间保持完美密封,在储存期间保护注射器头免受污染并用很小的力就能打开。
Claims (9)
1.一种端帽组件(30),其用于关闭注射系统(10)的远端伸出头部(13)的流体通道(14),所述端帽组件(30)包括:
-弹性内帽(50),该弹性内帽具有远端表面(53)、径向边缘(57)和限定作为所述远端表面(53)和所述径向边缘(57)之间距离的长度L2,
-刚性外帽(40),该刚性外帽牢固地或可牢固地布置在所述弹性内帽(50)的周围,所述刚性外帽(40)具有肩部(42f)、至少一个抵接表面(42e)和限定作为所述至少一个抵接表面(42e)和所述肩部(42f)之间距离的长度L1,
其中,弹性内帽(50)在远端由于所述远端表面(53)和所述至少一个抵接表面(42e)相接触而阻断,在近端由于所述径向边缘(57)和所述肩部(42f)相接触而阻断,并且其中长度L1大于长度L2,以允许所述弹性内帽(50)在所述刚性外帽(40)内进行有限移动。
2.如权利要求1所述的端帽组件(30),进一步具有应力限制机构(42a,42b,54),当所述端帽组件关闭所述流体通道(14)时,所述应力限制机构允许所述弹性内帽(50)明显变形。
3.如权利要求2所述的端帽组件(30),其中所述应力限制机构包括位于所述刚性外帽(40)上的至少一个窗口。
4.如权利要求3所述的端帽组件(30),其中所述应力限制机构包括位于所述刚性外帽(40)上的两个径向相对的纵向窗口(42b)。
5.如权利要求2所述的端帽组件(30),其中所述应力限制机构包括位于所述刚性外帽(40)中的远端开口(42a)。
6.如权利要求3所述的端帽组件(30),其中所述应力限制机构包括位于所述刚性外帽(40)中的远端开口(42a)。
7.如权利要求4所述的端帽组件(30),其中所述应力限制机构包括位于所述刚性外帽(40)中的远端开口(42a)。
8.如权利要求1到7中任一项所述的端帽组件(30),其中所述肩部(42f)位于所述刚性外帽(40)的远端部分(42)和中间部分(43)之间。
9.一种注射系统(10),其包括纵向筒(11)、具有贯穿其中的流体通道(14)的远端伸出头部(13)、远端表面(15)和侧面(16),其中所述注射系统(10)进一步包括根据权利要求1到8中任一项所述的端帽组件(30)。
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- 2014-10-15 CN CN201420874047.6U patent/CN204798514U/zh not_active Withdrawn - After Issue
- 2014-10-15 CN CN202111140079.4A patent/CN113842526A/zh active Pending
- 2014-10-15 CN CN202110422798.9A patent/CN113101464B/zh active Active
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2021
- 2021-04-26 US US17/240,484 patent/US20210244892A1/en active Pending
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