CN1086145A - 一种防倒退的皮下注射器 - Google Patents

一种防倒退的皮下注射器 Download PDF

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CN1086145A
CN1086145A CN93119148A CN93119148A CN1086145A CN 1086145 A CN1086145 A CN 1086145A CN 93119148 A CN93119148 A CN 93119148A CN 93119148 A CN93119148 A CN 93119148A CN 1086145 A CN1086145 A CN 1086145A
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D·C·哈里斯
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Eli Lilly and Co
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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
    • A61M5/48Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests having means for varying, regulating, indicating or limiting injection pressure
    • 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
    • A61M5/315Pistons; Piston-rods; Guiding, blocking or restricting the movement of the rod or piston; Appliances on the rod for facilitating dosing ; Dosing mechanisms
    • A61M5/31533Dosing mechanisms, i.e. setting a dose
    • A61M5/31545Setting modes for dosing
    • A61M5/31548Mechanically operated dose setting member
    • A61M5/3155Mechanically operated dose setting member by rotational movement of dose setting member, e.g. during setting or filling of a syringe
    • A61M5/31551Mechanically operated dose setting member by rotational movement of dose setting member, e.g. during setting or filling of a syringe including axial movement of dose setting member
    • 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
    • A61M5/50Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests having means for preventing re-use, or for indicating if defective, used, tampered with or unsterile
    • 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
    • A61M5/315Pistons; Piston-rods; Guiding, blocking or restricting the movement of the rod or piston; Appliances on the rod for facilitating dosing ; Dosing mechanisms
    • A61M5/31501Means for blocking or restricting the movement of the rod or piston
    • A61M2005/3151Means for blocking or restricting the movement of the rod or piston by friction
    • 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
    • A61M5/24Ampoule syringes, i.e. syringes with needle for use in combination with replaceable ampoules or carpules, e.g. automatic
    • 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
    • A61M5/315Pistons; Piston-rods; Guiding, blocking or restricting the movement of the rod or piston; Appliances on the rod for facilitating dosing ; Dosing mechanisms
    • A61M5/31533Dosing mechanisms, i.e. setting a dose
    • A61M5/31545Setting modes for dosing
    • A61M5/31548Mechanically operated dose setting member
    • A61M5/31563Mechanically operated dose setting member interacting with a displaceable stop member
    • 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
    • A61M5/315Pistons; Piston-rods; Guiding, blocking or restricting the movement of the rod or piston; Appliances on the rod for facilitating dosing ; Dosing mechanisms
    • A61M5/31565Administration mechanisms, i.e. constructional features, modes of administering a dose
    • A61M5/31576Constructional features or modes of drive mechanisms for piston rods
    • A61M5/31578Constructional features or modes of drive mechanisms for piston rods based on axial translation, i.e. components directly operatively associated and axially moved with plunger rod
    • A61M5/3158Constructional features or modes of drive mechanisms for piston rods based on axial translation, i.e. components directly operatively associated and axially moved with plunger rod performed by axially moving actuator operated by user, e.g. an injection button
    • 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
    • A61M5/315Pistons; Piston-rods; Guiding, blocking or restricting the movement of the rod or piston; Appliances on the rod for facilitating dosing ; Dosing mechanisms
    • A61M5/31565Administration mechanisms, i.e. constructional features, modes of administering a dose
    • A61M5/3159Dose expelling manners
    • A61M5/31593Multi-dose, i.e. individually set dose repeatedly administered from the same medicament reservoir

Abstract

一种防倒退装置,其可阻止螺帽在剂量结束的位 置处旋转剂量调节钮向设定剂量的方向相反的方向 转动。该装置包括一个装在螺帽的挠性臂的端部的 棘爪,它与注射器圆筒内的槽相配合。螺帽也包括在 端部设有一个与圆筒内的一个倾斜面紧密配合的倾 斜面,且两个斜面的紧密配合在剂量结束的位置处把 棘爪推入一个槽中,并阻止螺帽按错误的方向转动。

Description

本发明涉及一种注射剂量经严格度量的药剂的装置。更具体地说本发明是涉及一种具有一般外形与笔或机械铅笔相同的皮下注射器,它特别适用于提供多个剂量定量的药剂,比如胰岛素或人体生长荷尔蒙。
糖尿病患者或其他人常常发现自己处于没有保健专业人员可以提供帮助来进行数量定量的液体药剂的皮下或肌肉内注射的境况。而处在这种情况下,这些人就需要有一种成本低的注射器,这种注射器不需要保健专业人员的帮助就能得到所要求的定量精度。常常有这样的情况,即这些人每天需要注射多于一次剂量的药剂,每次剂量的体积或多或少有些不同。已经知道有这样一种一般类型的药剂分配器,它具有笔或机械钢笔的一般外形。这种药剂分配器通常大到足以储存几次这样的剂量,但它又很小,小到足以方便地适于放在人们的衣袋或钱袋中。这些装置的例子可在美国专利4,973,318;4,413,760;4,498,904;3,613,952;4,475,905;4,883,472;以及4,592,745号中找到。另外的例子可见PCT国际出版物WO87/02895;WO88/07874;WO82/02662;PCTCH86/00151;PCT        DK88/0064。
在这类装置中,液体的容器一般有一封闭的第一端部,该端适于由一个针头组件穿透,以使容器中的液体能够排出注射。容器的第二端部通常由一个活塞封闭。为了防止液体容器的滥用或再用。通常都把活塞设计成可以对活塞施加一个推力来减少容器所保存的液体体积,但不适于拉活塞而使容器中所保存的液体体积增加。
一个具有柱塞杆性质的细长件放在壳套内,用来对封闭容器的第二端部的活塞施力。一装置提供了一个测量柱塞杆的移动距离以确定液体容器体积的减少,这种减少形成容器内液体的剂量的分配。通常认为剂量分配器应该具有某种特点:即只允许柱塞杆按一个方向朝着活塞运动而阻止在柱塞杆上的任何作用力可能会使液体容器的体积增大。装在容器封闭端上的针头组件通常有一个保险盖。
尽管先有技术的笔型注射器获得了某种成功,但也观察到了一些缺点。在某些先有技术的注射器中,难以保证在一次剂量被注射后不出现倒退,这种倒退非故意地改变了用于下一次剂量的活塞行程的长度。
本发明提供了一种防倒退装置,该装置可防止螺帽在剂量结束的位置处由于沿与把螺帽向上移动用来设定一下个剂量的方向相反的方向转动,而向带螺纹的活塞的上部移动。以这样的方式可确保螺帽向带螺纹活塞上部的移动是由于按适当的方向旋转了剂量调节钮而实现的。
本发明提供了一种改进的装置,该装置用以防止在皮下注射器的园筒内的带螺纹的活塞杆上的螺帽在剂量结束的位置处发生倒退;它包括有:一个在螺帽上的与园筒内的一个棘轮相配合的棘爪和一个在螺帽上的装置,该装置与园筒中的一个用以在剂量结束的位置处把棘爪推入棘轮中,用来防止螺帽按与设定剂量的方向相反的方向转动的装置相配合。
本发明包括一种改进的装置,该装置用以防止在皮下注射器的园筒内的带螺纹的活塞杆上的螺帽在剂量结束的位置处发生倒退;它包括有:一个在螺帽端部的棘爪,该棘爪与皮下注射器的注射器园筒内壁上的槽相配合,允许螺帽向带螺纹的活塞杆的上部移动,用以设定剂量,和设在螺帽端部的第一表面,该表面在剂量结束的位置处与园筒内的第二表面相配合,用来把棘爪推入到园筒内的一个槽中,并阻止螺帽按与设定剂量的方向相反的方向转动。
最好选择把棘爪装在一个整体注塑在螺帽的端部的挠性臂上,并且在螺帽端部的第一表面是一个倾斜面,而园筒内的第二表面是一个与第一斜表面紧密配合的倾斜面,其中此二倾斜面在剂量结束的位置处的紧密配合阻止挠性棘爪臂向里面移动,并把棘爪保持在园筒的一个槽中,从而防止按错误的方向转动。
本发明的结构、特点以及其他目的,将通过下面的附图以及实施例予以详细描述,其中:
图1是使用中的注射器的顶视图;
图2是防倒退机构的局部剖面图;
图3是防倒退机械内部结构的局部透视示意图;
图4是沿图2中4-4线截取的部分剖面图;和
图5是混合的剖面和顶视图,其示出有拆开的部件。
图1示出注射器组件1。注射器组件1包括有一连接于注射管3的远端上的针头组件2,而注射管3内设有一个装着被注射液体的容器4。一个设有螺纹的活塞杆5与柱塞6的接触而使得活塞杆5能让柱塞6移动,并且向下的运动迫使液体由针头排出。上帽盖7可滑动地装在注射器壳套(或管)3的近端上。衣袋夹8作为上帽盖7的一部分整体注塑而成。将一个剂量调节钮15装入到位于上帽盖7的近端上的一个开口11中。转动剂量调节钮15可使与剂量调节钮相连的一个内部螺帽向上拉活塞杆5并使活塞杆有效地伸长,从而使剂量调节钮达到位置15b,这个位置相应于一个精确定量的剂量,该剂量可以通过窗口12在一个刻度标尺上观察到。由位置15b把剂量调节钮推至位置15a可使数量定量精确的液体经针头射出。
对图1装置的准确表述(以上只作了一般性的解释)可参见已公开的欧洲专利申请496,141号(公开于1992年7月29日),其说明书在这里被用作参考。
现在参看图2-5,这些图描述了本发明的优选实施例的细节。
图2表示按顺时针方向旋转剂量调节钮15来设定剂量。这样可使剂量调节钮能由位置15a移至位置15b,并使螺帽10在带螺纹的活塞杆5上沿剂量调节钮的方向移动用来设定剂量。在这一操作过程中,带螺纹的活塞杆被推进螺帽20和此推进螺帽的叉齿21定位,此叉齿使得带螺纹的活塞杆5保持不能转动,也不能向剂量调节钮移动。还有,当剂量调节钮按顺时针方向转动时,螺帽10上的棘爪25越过园筒27上的槽26。
当推动剂量调节钮15以排出剂量时,螺帽的被加工有斜面的端部28达到位置30以至螺帽的这一端在注射剂量结束的位置处与园筒27内部的环形倾斜面29的被加工成的斜面相啮合。企图按逆时针方向旋转剂量调节钮15就会造成螺帽斜表面28对园筒斜表面29的施以压力。这时螺帽10上的棘爪25移动到环形倾斜面29的上面并进入园筒槽26中,进而限制螺帽10的倒退。推进螺帽20上的凸缘(或叉齿)21阻止带螺纹的活塞杆在剂量调节钮的方向上移动。因此,当企图将螺帽逆时针旋转时,螺帽端部上与园筒内的两个斜表面的紧密配合阻止装有棘爪25的挠性臂32向里面弯曲,并把棘爪推入槽中。
图3示出了一改进的防倒退结构的部分剖面透视图。此图表示带有两个沟槽35的带螺纹的活塞杆5和阻止此带螺纹的活塞杆转动或向剂量调节钮移动的推进螺帽20上的凸缘(或叉齿)21。图3也示出了分别在螺帽上和园筒内的倾斜表面28与29之间的紧密配合。还示出了棘爪25和在园筒27内表面上的多个槽26。螺帽10带螺纹的活塞杆间的关系也被示出。
图4给出图2中沿平面4-4剖开的部分剖面图。图4表示棘爪25是如何装在挠性臂32上的,以至当转动螺帽来设定剂量时棘爪在园筒27的槽26中弹入、弹出。图2箭头示出将螺帽向带螺纹的活塞上部移动来设定剂量时的转动方向。当推动剂量调节钮15时,调节钮15将朝着上帽盖前进来排出剂量,在剂量结束的位置处倾斜面28与29的相互作用把棘爪25推入槽26中,以防止螺帽倒退。
图5示出拆卸下来的零件,其包括:带螺纹的活塞杆5,螺帽10,开有槽的园筒27,推进螺帽20,剂量调节钮15和帽盖7。剂量调节钮的园柱16紧紧地配合装进螺帽10的开口16中而使之有效地成为一个整体,这样一来,当转动剂量调节钮时螺帽也转动。将螺帽10用螺纹拧到带螺纹的活塞杆5上。把螺帽10的棘爪段插入开有槽的园筒18中。带螺纹的活塞杆的端部被置放在位于园筒中位置19处的推进螺帽20中。上帽盖7有一开口11用来接受园柱16。
推进螺帽20用金属如铜或不锈钢制成。其它部份为注塑件,这比如剂量调节钮、带螺纹的活塞杆、开有槽的园筒和上帽盖。本技术领域中的技术人员能在形状和尺寸以及在剂量结束的位置处使棘爪推入槽中的螺帽上和园筒中的两个表面的位置得以理解;类似地,本领域技术人员能认识到各种棘爪与棘轮的配合和定位,就可以实现本发明的目的。
以上所述的本发明的实施例是力图说明本发明,而并不是在创作精神或范围上限制本发明。

Claims (3)

1、一种用来在剂量结束的位置处防止放在皮下注射器的园筒中的带螺纹的活塞杆上的螺帽倒退的装置,其特征在于,其包括有:一个在螺帽上的与园筒中的棘轮相配合的棘爪和一个在螺帽上的装置,该装置与园筒内的一个用于在剂量结束的位置处把棘爪推入棘轮中,用以阻止螺帽按与设定剂量的方向相反的方向转动的装置相配合。
2、一种按照权利要求1所述的用来在剂量结束的位置处防止放在皮下注射器的园筒中的带螺纹的活塞杆上的螺帽倒退的装置,其特征在于,其包括有:在螺帽端部的一个棘爪,该棘爪与皮下注射器的注射器园筒内的槽相配合,以允许螺帽带螺纹的活塞杆的上部移动,用以设定剂量,和在螺帽端部的第一表面,该表面与园筒内的第二表面相配合在剂量结束的位置处把棘爪推入到园筒内的一个槽中,并阻止螺帽按与设定剂量的方向相反的方向转动。
3、一种按照权利要求2所述的防螺帽倒退的装置,其特征在于,棘爪被装在一个挠性臂上,并且在螺帽端部的第一表面是一个倾斜面,而园筒内的第二表面是一个与第一斜表面紧密配合的倾斜面,其中此二倾斜面的紧密配合阻止挠性棘爪臂向里面移动,并把棘爪保持在园筒的一个槽中。
CN93119148A 1992-10-20 1993-10-19 一种防倒退的皮下注射器 Pending CN1086145A (zh)

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CN104203312A (zh) * 2012-04-05 2014-12-10 赛诺菲-安万特德国有限公司 包括粘结剂以在装置寿命完结时阻挡驱动以防止再次使用的药物输送装置的驱动机构

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CN100435872C (zh) * 2001-07-30 2008-11-26 特克法马许可公司 包括旋转挡块的给药设备及用于给药设备的存储模块
CN102238974B (zh) * 2008-12-04 2014-09-03 赛诺菲-安万特德国有限公司 具有保持装置以防止活塞杆的不期望运动的注射装置
CN104203312A (zh) * 2012-04-05 2014-12-10 赛诺菲-安万特德国有限公司 包括粘结剂以在装置寿命完结时阻挡驱动以防止再次使用的药物输送装置的驱动机构

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HU215007B (hu) 1998-08-28
FI934606A0 (fi) 1993-10-19
BR9304291A (pt) 1994-04-26
AU673376B2 (en) 1996-11-07
MX9306462A (es) 1994-05-31
IL107290A0 (en) 1994-01-25
ES2118906T3 (es) 1998-10-01
PH31147A (en) 1998-03-20
DK0594349T3 (da) 1998-10-26
MY109584A (en) 1997-02-28
AU4902293A (en) 1994-05-05
US5545147A (en) 1996-08-13
IL107290A (en) 1998-07-15
PL172913B1 (pl) 1997-12-31
EP0594349A1 (en) 1994-04-27
CA2108588A1 (en) 1994-04-21
FI934606A (fi) 1994-04-21
CZ214793A3 (en) 1994-05-18
KR940008703A (ko) 1994-05-16
JPH06190040A (ja) 1994-07-12
DE69319687D1 (de) 1998-08-20
ZA937559B (en) 1995-04-12
EP0594349B1 (en) 1998-07-15
DE69319687T2 (de) 1998-12-24
HU9302944D0 (en) 1994-03-28
ATE168276T1 (de) 1998-08-15
NZ248921A (en) 1996-06-25
HUT67187A (en) 1995-02-28
NO933696D0 (no) 1993-10-14
NO933696L (no) 1994-04-21
YU65893A (sh) 1996-02-19
NO306810B1 (no) 1999-12-27

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