CN1294997C - 安全针组件 - Google Patents

安全针组件 Download PDF

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CN1294997C
CN1294997C CN 02823742 CN02823742A CN1294997C CN 1294997 C CN1294997 C CN 1294997C CN 02823742 CN02823742 CN 02823742 CN 02823742 A CN02823742 A CN 02823742A CN 1294997 C CN1294997 C CN 1294997C
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safety
needle
assembly
safety needle
needle assembly
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CN 02823742
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CN1596138A (zh )
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卡尔斯滕·詹森
尼尔斯·尼马克
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诺沃挪第克公司
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    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES 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
    • A61M5/00Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
    • A61M5/178Syringes
    • A61M5/31Details
    • A61M5/32Needles; 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
    • A61M5/3205Apparatus for removing or disposing of used needles or syringes, e.g. containers; Means for protection against accidental injuries from used needles
    • A61M5/321Means for protection against accidental injuries by used needles
    • A61M5/3243Means for protection against accidental injuries by used needles being axially-extensible, e.g. protective sleeves coaxially slidable on the syringe barrel
    • A61M5/3245Constructional features thereof, e.g. to improve manipulation or functioning
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES 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
    • A61M5/00Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
    • A61M5/178Syringes
    • A61M5/31Details
    • A61M5/32Needles; 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
    • A61M5/3205Apparatus for removing or disposing of used needles or syringes, e.g. containers; Means for protection against accidental injuries from used needles
    • A61M5/321Means for protection against accidental injuries by used needles
    • A61M5/3243Means for protection against accidental injuries by used needles being axially-extensible, e.g. protective sleeves coaxially slidable on the syringe barrel
    • A61M5/3257Semi-automatic sleeve extension, i.e. in which the triggering of the sleeve extension requires a deliberate action by the user, e.g. manual release of spring-biased extension means
    • A61M5/326Fully automatic, i.e. in which the triggering does not require a deliberate action by the user
    • BPERFORMING OPERATIONS; TRANSPORTING
    • B42BOOKBINDING; ALBUMS; FILES; SPECIAL PRINTED MATTER
    • B42DBOOKS; BOOK COVERS; LOOSE LEAVES; PRINTED MATTER CHARACTERISED BY IDENTIFICATION OR SECURITY FEATURES; PRINTED MATTER OF SPECIAL FORMAT OR STYLE NOT OTHERWISE PROVIDED FOR; DEVICES FOR USE THEREWITH AND NOT OTHERWISE PROVIDED FOR; MOVABLE-STRIP WRITING OR READING APPARATUS
    • B42D15/00Printed matter of special format or style not otherwise provided for
    • GPHYSICS
    • G09EDUCATION; CRYPTOGRAPHY; DISPLAY; ADVERTISING; SEALS
    • G09FDISPLAYING; ADVERTISING; SIGNS; LABELS OR NAME-PLATES; SEALS
    • G09F1/00Cardboard or like show-cards of foldable or flexible material
    • G09F1/04Folded cards
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES 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
    • A61M5/00Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
    • A61M5/178Syringes
    • A61M5/31Details
    • A61M5/32Needles; 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
    • A61M5/3205Apparatus for removing or disposing of used needles or syringes, e.g. containers; Means for protection against accidental injuries from used needles
    • A61M5/321Means for protection against accidental injuries by used needles
    • A61M5/3243Means for protection against accidental injuries by used needles being axially-extensible, e.g. protective sleeves coaxially slidable on the syringe barrel
    • A61M5/3245Constructional features thereof, e.g. to improve manipulation or functioning
    • A61M2005/3247Means to impede repositioning of protection sleeve from needle covering to needle uncovering position
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES 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
    • A61M5/00Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
    • A61M5/178Syringes
    • A61M5/31Details
    • A61M5/32Needles; 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
    • A61M5/3205Apparatus for removing or disposing of used needles or syringes, e.g. containers; Means for protection against accidental injuries from used needles
    • A61M5/321Means for protection against accidental injuries by used needles
    • A61M5/3243Means for protection against accidental injuries by used needles being axially-extensible, e.g. protective sleeves coaxially slidable on the syringe barrel
    • A61M5/3257Semi-automatic sleeve extension, i.e. in which the triggering of the sleeve extension requires a deliberate action by the user, e.g. manual release of spring-biased extension means
    • A61M5/326Fully automatic, i.e. in which the triggering does not require a deliberate action by the user
    • A61M2005/3267Biased sleeves where the needle is uncovered by insertion of the needle into a patient's body
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES 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
    • A61M2205/00General characteristics of the apparatus
    • A61M2205/60General characteristics of the apparatus with identification means
    • A61M2205/6063Optical identification systems
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES 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
    • A61M5/00Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
    • A61M5/002Packages specially adapted therefor, e.g. for syringes or needles, kits for diabetics
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES 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
    • A61M5/00Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
    • A61M5/178Syringes
    • A61M5/31Details
    • A61M5/32Needles; 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
    • A61M5/3205Apparatus for removing or disposing of used needles or syringes, e.g. containers; Means for protection against accidental injuries from used needles
    • A61M5/321Means for protection against accidental injuries by used needles
    • A61M5/3243Means for protection against accidental injuries by used needles being axially-extensible, e.g. protective sleeves coaxially slidable on the syringe barrel
    • A61M5/3271Means for protection against accidental injuries by used needles being axially-extensible, e.g. protective sleeves coaxially slidable on the syringe barrel with guiding tracks for controlled sliding of needle protective sleeve from needle exposing to needle covering position

Abstract

本发明涉及对人体注射液体的安全针组件,该组件包括:圆筒形壳体,具有支撑针管的底面;和保护套,可以相对于壳体伸缩运动。设置在壳体内的弹簧迫使保护套处于远端针覆盖方向,锁定元件也设置在壳体内,在注射过程中与保护套同时运动,并自动将保护套锁定在使针管的尖端被隐蔽的位置,从而不可逆转地使安全针组件固定不动。

Description

安全针组件

发明领域本发明涉及安全针组件,该针组件减少意外针头阻塞伤害的风险,特别涉及针管安装在套内的安全针组件。

相关技术说明针组件通常或是用于注射物质进入人或动物的身体,或是用于从其身体内抽出物质。这些针组件一般是可以随意使用的,而且只使用一次后就废弃。针组件的随意使用所存在的问题,以及确实由针组件的任何处理所存在的问题在于,由针管锋利尖端引起伤害的潜在风险。在穿刺患者皮肤之后接着使用是特别危险的,因为针管可能被污染,因此可能传播诸如肝炎和艾滋病病毒。

已经开发出大量的安全针组件,其中,在注射过程中,针管被一种可以伸缩运动的保护套隐藏起来。

WO 01.76665公开了现有技术中的这样一种针保护系统。这种安全针包括一种套,该套具有设置在中央的针管。一种可伸缩的保护套设置在套的外表面。保护套可以在第一位置与第二位置之间伸缩运动,在第一位置时,保护套完全覆盖针管,在第二位置时,针管或针管的一部分不被覆盖以进行一次注射。一种可以旋转地安装在套上的凸轮元件,设置了至少一个凸轮,此凸轮由设置在保护套内表面的凸轮曲面所引导。保护套被设置在套与保护套之间的弹簧迫使其趋向远端方向。当已经执行完一次注射后,保护套返回第一位置时,凸轮曲面适于将凸轮阻挡在阻挡位置。但是,WO 01.76665所公开的安全针组件是笨重的,而且包含大量的零件,这些零件必须模制而成,然后极其精密地装配在一起,以便获得凸轮随动件的正确运动。

一个装配结构中的不同塑料零件,在该结构用蒸汽或气体消毒时,具有改变相对尺寸的趋势,这也是事实。在容许误差不得不极小时,就像WO 01.76665所公开的安全针组件那样,这一点特别严重。

为了在已经注射后保护帽运动返回其初始位置时,保证WO01.76665的凸轮元件事实上移动到锁定位置,需要更强力的弹簧。这对于使用人是麻烦事,因为在进行注射时,使用人不得不真正用他或她的皮肤向近端方向推压保护帽。

对发明的说明本发明的目的之一在于提供一种安全针组件,该装置克服了现有技术中安全针组件的麻烦,并特别提供一种安全针组件,该装置由更少的零件构成,而且这些零件不要求具有极严的容许误差。

本发明的又一个目的在于提供一种具有弹簧的安全针组件,该弹簧只需要有限的力,从而给予使用人极大的舒适性。

为了克服现有技术中的缺点,根据本发明的技术方案,建议为安全针组件提供一种单独的锁定元件,设置在弹簧与保护套之间。

本发明的技术方案如下:根据本发明,提供一种安全针组件,该组件包括:圆筒形壳体,其具有顶表面和底表面,所述壳体具有将所述壳体安装在医学注射装置上的元件;针管,该针管安装在底面,所述针管具有设置在底面远侧的远端;保护套,其可以相对于壳体伸缩运动,以在远端位置和近端位置之间运动,在其远端位置时,保护套覆盖针管的远端,在其近端位置时,针管的远端的至少一部分是暴露在外的;弹簧,其设置在所述壳体内,迫使保护套趋向远端;锁定元件,其设置在壳体内,并具有至少一个指向外的锁定突出部;其特征在于,所述锁定元件是一个独立的部分,其设置在弹簧与保护套之间,在使用过程中,与保护套同时相对于壳体纵向运动,因此,设置在锁定元件上的锁定突出部被引导,从保护套处于远端位置的第一位置,经过保护套处于近端的第二位置,到达保护套处于远端位置的第三位置,而在第三位置,至少锁定突出部其中之一被设置在壳体内表面的阻挡表面所阻挡,因此,保护套的进一步运动被不可逆转地阻止了。

当锁定元件作为单独元件设置在弹簧与保护套之间,并与保护套同时运动,在锁定元件纵向运动的过程中,锁定突出部可以被引导,从而取消了轨道或凸轮的必要,于是除套以外只需要三个塑料制件,就可以构成安全针组件。

由于没有轨道或者凸轮,因此内部构件的公差并不那么重要,而摩擦可以保持得相当低,这就使得可以使用稍软的弹簧,从而提高使用人的舒适性。

根据本发明的优选的方案:在第一位置的锁定元件的锁定突出部,贴靠设置在保护套上的突键和设置在壳体内表面上的鳍片。通过设置在壳体内表面的鳍片,阻挡锁定突出部的旋转运动,当锁定突出部的可旋转运动将要开始时,可以简单地通过规定鳍片的特定长度予以限定。

本发明另一个优选方案为:当突键的一个成角度的表面对准鳍片的一个成角度的表面时,锁定元件和锁定突出部相对于壳体和保护套转动。

一旦锁定元件上的锁定突出部已经越过该优选方案中所述的鳍片端部,就将不可能使锁定突出部向后运动。鳍片的长度可以制成这样,使保护套一旦已经被致动,而针管已经从保护套内的开口显现出来,就不可能停止注射而将针保存起来供以后使用。

根据另一个优选方案:在第二位置的锁定元件的锁定突出部,贴靠设置在保护套近端的齿圈。锁定突出部与保护套的齿圈接合时,保护套可以向近端方向沿路运动返回,从而解除对针管的覆盖。

本发明进一步优选的方案为:在第三位置的锁定元件的锁定突出部,被阻止在一个纵向肋条的开口中,该肋条设置在壳体的内表面,此开口限定了阻挡表面。

当注射结束,锁定突出部如该优选方案所述被阻止在纵向肋条的开口中时,事实上不可能通过将保护套压回近端方向而使针管再次前进。

本发明又一优选方案如下:用以引导锁定元件上锁定突出部的引导装置,包括设置在壳体内表面的肋条和鳍片,此肋条和鳍片只沿水平方向延伸。

引导锁定突出的引导装置,只包括如该优选方案所规定的水平限定的肋条和鳍片,这就使零件的模制和零件的装配两者均很简单。

本发明的再一优选方案为:保护套安装在壳体内,并经过设置在壳体顶表面的一个开口穿出。

借助于如该优选方案所述方式在壳体内部安装保护套,保证了保护套不会从壳体分离。

本发明进一步优选的方案为:弹簧使锁定元件与壳体的底面相联系。

如该优选方案所表明,当竖起设置(cocked)在锁定元件和套之间的弹簧,使锁定元件与壳体的底面相联系时,保证了弹簧用极简单的方式加入到装配体中。

借助于在壳体上设置窗口,当锁定突出部处于被阻止位置时,通过此窗口可以观察到锁定突出部,这就保证了使用人可以用视觉检测安全针组件在此前是已经使用过还是未曾使用。

通过窗口可以观察到的保护套和/或锁定元件的部分,当安全针组件处于未使用状态时,也可以着以颜色,以表明安全针组件准备就绪待用。

窗口既可以是透明的,也可以是壳体侧壁上一种简单的开口。

在本说明中,用于描述保护套与锁定元件之间运动关系的术语“同时运动”,并不是指保护套与锁定突出部必须以相同的速度运动。运动的相对速度由各种成角度表面所限定,因此是变化的。术语“同时运动”仅仅意味着保护套与锁定突出部同时运动。

对附图的简要说明对本发明将结合推荐实施例并参考附图更全面地说明如下,其中:图1示出了根据本发明的安全针组件的透视图;图2示出了根据本发明的安全针组件的分解图;图3示出了针保护套的透视图;图4示出了锁定元件的透视图;

图5示出了壳体本体的透视图;图6示出了壳体本体的示意图;图7示出了根据本发明的安全针组件的示意图;图8示出了根据本发明的安全针组件的示意图,其中壳体的一部分被切除;图9示出了锁定突出部处于其第一位置;图10示出了锁定突出部处于其第二位置或向其第二位置运动;图11示出了从第二位置向第三位置运动的锁定突出部的运动;图12示出了在第三位置的锁定突出部;图13示出了根据本发明的安全针组件的一个实施例的透视图;图14示出了根据本发明的安全针组件的一个实施例的壳体的一部分;图15示出了根据本发明的安全针组件的分解图;图16示出了存储在一个容器中的安全针组件的透视图。

附图均为原理图,并为清楚起见进行了简化,而且这些图仅仅示出了对于理解本发明必不可少的那些细节,而其它的细节均予省略。在各图中,相同的字符用以表示相同或相对应的部分。

对实施例的详细说明一开始就对术语进行定义是合适的,术语“远端”的含义指的是安全针组件插入患者的端部,而术语“近端”的含义指的是与注射装置连接的端部。

图1示出了一种安全针组件,该组件包括壳体1和保护套2,壳体1由套3和本体4组成。套3和本体4通常是粘结或焊接在一起。

套3与本体4之间的连接表面,在图中所示是处于特定的位置,不过当然可以根据需要设置。套3和本体4甚至可以模制成一件,该件在顶表面6由唇缘(lit)封闭。顶表面6设置了开口8,保护套2从该开口显现。

保护套2设置了针的通路孔7,针管30可以穿过该通路孔。保护套2的近端,如图所示,设置了八个向外突起的突键10,该突键10的前端11为平面,而后端12为成角度的表面。

壳体1具有底面9,在其中央安装了针管30。针管30既可以安装成使针管30的一部分从底面9沿近端方向突出,这推荐与针筒一起使用,或者,也可以将其安装成没有这种所谓的背针(back needle),这推荐用于皮下注射。邻近底面9,在壳体1的近端,设置了将安全针组件安装在注射装置上的装置。这些装置通常是螺纹35,于是可以将安全针组件拧入一种笔式注射器。

图3示出了从近端观察的保护套2。八个突键10以八个尺寸相等的空间间距26彼此分离。突键10成角度的后面12与保护套2一起构成一个齿圈13,其中,突键10的中心构成顶部,而在空间间距26内的保护套10构成谷底。

在图2中所见的锁定元件16,在其近端的外表面设置了四个锁定突出部17。如图4所示,这些突出部17具有成角度的前端18和成平面的后端面19。

壳体1的本体4在图5中示出其透视图,在图6中示出其剖视图。本体4设有四个窗口20,并为每一个窗口设置一个纵向肋条21。肋条21设置在本体4的内表面。这些纵向肋条21沿本体4的整个长度延伸,不过被窗口20为两部分(21a,21b)。肋条21的远端均匀模制出环圈24,设置在本体4的远端,并在窗口20远端的平直表面14处终结。肋条21的近端部在窗口近端阻挡表面15处终结,其用途将在后面说明。在本体4的远端设有四个鳍片22。这些鳍片22与在本体4远端的环圈24均匀模制在一起,并在鳍片的近端具有成角度的表面23,该成角度的表面大约在邻近窗20中间的位置终止。

尽管在此所述实施例具有八个突键10、四个具有锁定突出部17和四个窗口20,这些部分可以设置成不同的数目,如图15所示。

当对图2所示的安全针组件进行装配时,弹簧25设置在壳体1的底面9与锁定元件16之间,迫使锁定元件16和保护套2趋向远端。突键10上平直的前端11贴靠环圈24,这样,保护套2与壳体1的本体4连接。

装配成的安全针组件在图7和8中示出。图8示出了安全针组件的内部,其中,本体4被切除。

保护套2在壳体1的本体4内的设置,是使每一个肋条21和每一个鳍片22处于两个突键10之间的空间间距26内。不过,肋条21的上部21a在图8中未示出,这是由于上肋条21a不是整个必须的。此后,安装锁定元件16,使其在每一个锁定突出部17的成角度的前面18,贴靠保护套2的突键10上四个成角度的后表面12,因此,锁定突出部17的侧面与突键10的侧表面形成一条直线,此直线贴靠壳体1的本体4的鳍片22的侧表面。

一旦将保护套2和锁定元件16正确地安装在壳体1的本体4内,弹簧25则环绕针管30设置,本体4和套3被密封在一起,正式宣布使用准备就绪。

锁定突出部17的运动在图9-12示出其示意图,该图示出了在锁定元件16上的锁定突出部17其中之一、保护套2上突键10中的两个突键、壳体1的本体4内表面上的鳍片22其中之一,以及也设置在壳体1的本体4内表面上的肋条其中之一之间的相对位置。

图9示出了安全针组件处于其初始位置,如图8所示,保护套2处于其远端位置,在该位置,保护套2覆盖针管30。当保护套2被推向使用人的皮肤,保护套2和与之在一起的突键10沿箭头27所示向近端方向运动。此运动也使锁定元件16上的锁定突出部17反抗弹簧25的力F向近端方向运动。

锁定突出部17一旦运动到脱离鳍片22,如图10所示,锁定突出部17的成角度的前面18,将沿突键10的成角度的后面12和鳍片22的成角度的前面23滑动,如箭头28所示。此运动将使锁定突出部17运动进入与齿圈13的谷底部接触。保护套2的进一步运动,从而突键10在箭头27方向的运动,将只使锁定突出部17进一步向近端方向运动。于是,随着保护套2处于其最近端位置,注射得以进行。鳍片22和肋条21的位置,使突键10总是或者被鳍片22所引导,或者被肋条21所引导。

当注射完成后,针管30从使用人的皮肤缩回,这将使具有突键10的保护套2和具有锁定突出部17的锁定元件16,在弹簧25所施加的力F的作用下向远端方向运动。图11中的箭头29指示了这一运动。

图12示出了弹簧25的力F是如何迫使具有锁定突出部17的锁定元件16和具有突键10的保护套2向远端方向运动。当鳍片22上的成角度的前面23对准突键10的成角度的后面12时,使两个成角度的前面23、12形成一条斜线,锁定突出部17的成角度的前面18将沿此斜线滑动进入这样的位置,在该位置,锁定突出部17处于肋条21的上部21a与下部21b之间,即处于肋条21的上部21a的平直表面14与肋条21的下部21b的阻挡表面15之间。在此位置,锁定突出部17从而锁定元件16和保护套2被不可逆转地锁定。

在锁定突出部17的近端,平直的后面19将贴靠或者至少被壳体1的本体4的肋条21上的阻挡表面15所阻挡,因此使保护套2不可能向近端运动。在远端,锁定突出部17的成角度的前面18将贴靠保护套2的齿圈13,且由于保护套2上突键10的平直的前面11贴靠壳体1的本体4的环圈24,不可能使保护套2向远端方向运动。保护套2的突键10侧面将被抑制在肋条21的上部21a与鳍片22之间。这样的结果,保护套2将不可能在任何方向运动。

当注射结束时,取代使锁定突出部17的成角度的前面18与保护套的齿圈13接触,可以设计成一旦锁定突出部17处于锁定位置时,锁定元件16的前端36贴靠保护套2的内顶端37。这将使得通过向近端方向推动保护套2而挤压锁定突出部17的成角度的前面18事实上不可能。

壳体1的本体4设置了四个窗口20,此窗口20将四条肋条21的每一条分为上部21a和下部21b。当安全针组件已经使用过时,锁定元件16上的锁定突出部17将处于肋条21的上部21a和下部21b之间,于是可以通过窗口20观察到。锁定突出部17或者锁定突出部的一部分,可以着色为火红的(flammatory)颜色,或者设置另外的指示物,这些指示物对于使用人可以很容易地由视觉检测,仅需通过扫视窗口20就可以判明安全针组件已经用过或者没有用过,窗口20例如可以是在本体4的壁上的开口。

在使用前,安全针组件是经过杀菌消毒并封装成图7所示状态传送到使用人处。容器31在远端表面32处封闭,而在近端面33处打开。近端表面33用未示出的可去除的密封件密封。容器31在未示出的内表面具有肋条,该肋条与设置在壳体1外表面上,推荐设置在套3外表面上的肋条34匹配,这样,使安全针组件可以通过螺纹拧上或者螺纹拧下注射针,而不必从安全针组件上去除容器32。此外,容器可以在内表面设置许多未示出的凸起点,以某种程度的浮置位置支撑安全针组件,在这种形式的杀菌消毒进行过程中,使蒸汽或气体更容易充分环绕安全针组件。

迫使阻挡元件16和保护套2向远端运动的弹簧30,推荐用耐腐蚀的不锈钢制成,这样,弹簧30在蒸汽杀菌消毒过程中将不致损坏。特别适合此目的的弹簧30是一种1.4462/SAF2205弹簧。

根据本发明的安全针组件的另一个实施例公开在图13和图14中。

图13示出了壳体40,该壳体包括套41和本体42。壳体40内安装了保护套43和锁定元件44。保护套43从设置在壳体40远端的开口45穿出壳体40之外。

保护套43设有四个突键46,并在近端齿圈38处终结。

齿圈38与设置在锁定元件44上的第二齿圈39接合。锁定元件44还在其近端设有锁定突出部49。

在图13中,针管30安装在底面50内,此底面50设置在壳体40内,推荐设置在套41内。

图13示出了具有在锁定位置的保护套43的安全针组件,而图14示出了壳体40的内表面,这是通过切除图13中从后面观察到的本体40的一部分实现的。

保护套43上的四个突键46,由设置在壳体40内表面上的第一水平轨道51引导。锁定元件44上的锁定突出部49,在其初始位置贴靠平直表面48,当保护套43向近端运动时,该锁定突出部由第二水平轨道52引导。保护套43一旦已经沿路运动返回至其最近端位置,并进行注射,设置在底面50与锁定元件44之间的未示出的弹簧,将迫使锁定元件44,从而也迫使保护套43向远端运动。在此运动过程中,锁定突出部49的成角度的前面47,将与也设置在壳体40内表面内的一个倾斜轨道53结合。当保护套43运动返回其初始位置,锁定元件44,从而锁定突出部49将在倾斜轨道53内转动大约180度,并与设置在倾斜轨道53远端的锁定腔54接合,此锁定腔54具有一个阻挡表面55,锁定突出部49的平直后面56将与其贴靠,表明保护套43不可能进一步运动。保护套43的第一齿圈38和锁定元件44的第二齿圈39,由于其两个齿圈38、39的成角度表面的相互配合而保障(support)此运动。

由于突键46与第一水平轨道51接合,保护套43不可能相对于壳体40转动。既然保护套43的转动被约束住,就不可能使锁定元件44的锁定突出部49沿倾斜轨道53向后转动,锁定突出部49因此将保持在锁定腔54内,从而表明安全针组件是可靠的。

可以在壳体40设置一个窗口,通过该窗口可以观察到锁定腔54,这样,无论安全针组件已经用过或者没有用过,使用人都可以获得一种可视的指示。

在图1-12中所公开的安全针组件的经过改进的实施例,在图15和图16中示出。

在以下的说明中,所指元件与前面各图中元件相同时,其数字代号用前面所用数字代号加一百表示。

图15中所示安全针组件包括壳体,该壳体包括针套103和本体104,此两者均推荐用PP喷塑模制而成。针套103本身和针套103的柱(tower)两者,比图2所示的略微高些,而本体104略微短些。针管130插入针套103的柱,并通过胶水滴160粘结在针套103上。

在本实施例中的本体104设有三个窗口120,锁定元件116也设有三个锁定突出部117。当锁定元件116锁定安全针组件使其不能重复使用时,正如前面所述,三个锁定突出部117可以在三个窗口120中观察到。

保护套104推荐用TPX制成,该保护套可以是透明的,这样,针管130的尖部在使用人注射前检查时可以看见,保护套的近端具有六个突键110。因此,本实施例中,在这些突键110之间形成的齿圈113只具有六个凹部。

锁定元件116推荐用POM或PP制成,在锁定元件的远端表面设置了锯齿状圈161,该锯齿状圈是在制造过程中使用。当安全针组件装配时,可以使一种工具穿过保护套102中的针头通路孔107,进入安全针组件,并使其与锯齿状圈161接合,以便在保护套102和锁定元件116永久地封装在壳体内之前,将锁定元件116转动到正确位置。为此目的,针通路孔107需要足够大,以便让该工具(toll)通过针通路孔107。

在图10所示实施例中,当突键10沿纵向处于鳍片22与肋条21的下部21b之间时,略微存在保护套2转动的可能性。为了避免这种意外的转动,图15所示实施例的突键110,设有附加引导肋条162,此附加肋条由许多未示出的导轨所引导,该导轨设置在壳体的本体104内表面。由于这样,保护套104和本体104之间不可能存在转动。

当安全针组件装配完成,整个装置封装在容器131中,此容器131用可去除的密封163封装,并进行灭菌消毒。可去除的密封163推荐用纸制造。

容器131的远端部,可以制成如图16所示拥有预定容积的杯形物164。与安全针组件一起配合使用的注射装置的配药剂量,于是可以通过向杯164内排出预定数量的剂量进行控制,并校验排出量。这或者可以通过充满整个杯完成,或者可以通过在杯164上印制的指示物完成。

一些推荐实施例已经在前面示出,不过应当强调的是,本发明并不局限于这些,在下述权利要求所限定主题范围内,可以用其它的方式实施。

零件表1.壳体2.保护套3.套4.本体5.连接表面6.顶表面7.针头通路孔8.开口9.底面10.突键11.突键的前端平面12.突键成角度的后面13.齿圈14.平直表面15.阻挡表面16.锁定元件17.锁定突出部18.锁定突出部成角度的前面19.锁定突出部的平直后面20.窗口21.肋条21a.肋条上部21b.肋条下部22.鳍片23.成角度的表面24.环圈25.弹簧26.保护套上的空间间距

27.方向箭头28.方向箭头29.方向箭头30.针管31.容器32.容器的远端表面33.容器的近端表面34.壳体外表面上的肋条35.螺纹36.锁定突出部的前端37.保护套的内顶端38.保护套的齿圈39.锁定元件的第二齿圈40.壳体41.套42.本体43.保护套44.锁定元件45.开口46.突键47.锁定突出部成角度的前面48.平直表面49.锁定突出部50.底面51.第一水平轨道52.第二水平轨道53.倾斜轨道54.锁定腔55.阻挡表面

56.平直后面102.保护套103.套104.本体107.针通路孔110.突键113.齿圈116.锁定元件117.锁定突出部120.窗口125.弹簧130.针管131.容器160.粘结剂161.锯齿状环162.引导肋条163.密封164.杯

Claims (9)

1.一种安全针组件,该组件包括:圆筒形壳体(1,40),其具有顶表面(6)和底表面(9,50),所述壳体(1,40)具有将所述壳体(1,40)安装在医学注射装置上的元件;针管(30),该针管安装在底面(9,50),所述针管(30)具有设置在底面(9,50)远侧的远端;保护套(2,43),其可以相对于壳体(1,40)伸缩运动,以在远端位置和近端位置之间运动,在其远端位置时,保护套(2,43)覆盖针管(30)的远端,在其近端位置时,针管(30)的远端的至少一部分是暴露在外的;弹簧(25),其设置在所述壳体(1,40)内,迫使保护套(2,43)趋向远端;锁定元件(16,44),其设置在壳体(1,40)内,并具有至少一个指向外的锁定突出部(17,49);其特征在于,所述锁定元件(16,44)是一个独立的部分,其设置在弹簧(25)与保护套(2,43)之间,在使用过程中,与保护套(2,43)同时相对于壳体(1,40)纵向运动,因此,设置在锁定元件(16)上的锁定突出部(17,49)被引导,从保护套(2,43)处于远端位置的第一位置,经过保护套(2,43)处于近端的第二位置,到达保护套(2,43)处于远端位置的第三位置,而在第三位置,至少锁定突出部(17,49)其中之一被设置在壳体(1,40)内表面的阻挡表面(15,55)所阻挡,因此,保护套的进一步运动被不可逆转地阻止了。
2.如权利要求1所述的安全针组件,其特征在于,在第一位置的锁定元件(16)的锁定突出部(17),贴靠设置在保护套(1)上的突键(10)和设置在壳体(1)内表面上的鳍片(22)。
3.如权利要求2所述的安全针组件,其特征在于,当突键(10)的一个成角度的表面对准鳍片(22)的一个成角度的表面时,锁定元件(16)和锁定突出部(17)相对于壳体(1)和保护套(2)转动。
4.如权利要求3所述的安全针组件,其特征在于,在第二位置的锁定元件(16)的锁定突出部(17),贴靠设置在保护套(2)近端的齿圈(13)。
5.如权利要求4所述的安全针组件,其特征在于,在第三位置的锁定元件(16)的锁定突出部(17),被阻止在一个纵向肋条(21)的开口中,该肋条设置在壳体(1)的内表面,此开口限定了阻挡表面(15)。
6.如权利要求5所述的安全针组件,其特征在于,用以引导锁定元件(16)上锁定突出部(17)的引导装置,包括设置在壳体(1)内表面的肋条(21)和鳍片(22),此肋条(21)和鳍片(22)只沿水平方向延伸。
7.如权利要求1至6其中之一所述的安全针组件,其特征在于,保护套(2,43)安装在壳体(1,40)内,并经过设置在壳体(1,40)顶表面的一个开口(8,45)穿出。
8.如权利要求7所述的安全针组件,其特征在于,弹簧使锁定元件(16,44)与壳体(1,40)的底面(9,50)相联系。
9.如权利要求8所述的安全针组件,其特征在于,壳体(1,40)设有窗口(20),当锁定突出部(17,49)处于其第三位置时,通过此窗口(20)可以观察到锁定突出部(17,49)。
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