CN1320050A - 用于药物注射器装置的充药机构 - Google Patents

用于药物注射器装置的充药机构 Download PDF

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CN1320050A
CN1320050A CN99811343A CN99811343A CN1320050A CN 1320050 A CN1320050 A CN 1320050A CN 99811343 A CN99811343 A CN 99811343A CN 99811343 A CN99811343 A CN 99811343A CN 1320050 A CN1320050 A CN 1320050A
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injection device
cartridge case
medicinal liquid
plunger
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D·M·德贝尔
小P·R·莱施
S·J·尼斯隆
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Mei Di Jecht Co
Antares Pharma Inc
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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
    • A61M5/1782Devices aiding filling of syringes in situ
    • 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
    • A61M5/30Syringes for injection by jet action, without needle, e.g. for use with replaceable ampoules or carpules
    • 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
    • A61M5/30Syringes for injection by jet action, without needle, e.g. for use with replaceable ampoules or carpules
    • A61M5/3007Syringes for injection by jet action, without needle, e.g. for use with replaceable ampoules or carpules with specially designed jet passages at the injector's distal end
    • 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
    • A61M5/31511Piston or piston-rod constructions, e.g. connection of piston with piston-rod
    • 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
    • A61M5/46Devices 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 controlling depth of insertion
    • 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
    • A61M5/482Varying injection pressure, e.g. by varying speed of injection

Abstract

本发明公开了一种用于药物注射器装置的充药机构。本发明所述的充药机构包括一与第一、第二外壳部(12、14)滑动连接的药筒(16),该药筒在第一端设有挡块(66),并把第一或第二外壳部中的其中之一与一第二端连接;充药机构还包括与第一或第二外壳部中的其中另一个连接的药筒止动件(68),该药筒止动件与药筒挡块(66)在啮合点啮合,在注射器的柱塞(30)位于注射器药液腔室(28)的后部时可阻止药筒(16)的移动。从第二外壳部移开第一外壳部可在一第二方向上移动柱塞,把药液充入药液腔室,而向第二外壳部移动第一外壳部可在一第一方向上移动柱塞,从药液腔室排出药液。所公开的充药机构便于把药液注入注射器装置,并准备好注射器装置以备用。

Description

用于药物注射器装置的充药机构
发明领域
本发明涉及药物注射器,特别是涉及用于把药液注入药物注射器装置中的充药机构。
发明背景
在诸如授予Lilley等人的美国专利US5599302、授予Dunlap的专利US5062830以及授予Morrow等人的专利US4790824中所述的无针式注射器必须以足够穿透皮肤的压力(P穿透)射出药液,使药液可输送到所需的部位,通常是皮下区域。一般情况下,P穿透大约为4000psi。出于实现这种高压的需要,结构设计不得不受到某些限制,这些限制会影响无针式注射器许多方面的操作。其中一个方面就是无针式注射器要注入药液。
对于常用的含有针头的注射器来说,向注射器灌注药液仅需要简单的“推-拉”动作。具体地说,在针头插入药瓶时,往回拉动注射器的柱塞,向注射器灌注所需量的药液。从药瓶拔出针头之后,向前推动柱塞,准备好注射器,即排出任何空气气泡。与此相反,把药液灌入无针式注射器却是一费劲的、漫长的多步骤过程。例如,利用从Medi-Ject Corporation of Minneapolis,Minnesota购买的Medi-Ject ChoiceTM注射器,要在一第一方向上反复扭转注射器本体,备好注射器以便输送药液。下一步,用户把注射器的喷嘴放置在药瓶上,并在第二方向上反复扭转该本体,直到喷嘴腔抽入所需量的药液。最后,用户在第一方向上扭转该本体,准备好注射器,即从喷嘴腔排出任何空气气泡。由于Medi-Ject ChoiceTM注射器使用了力量很大的储能结构(即螺旋弹簧),弯曲注射器本体是很困难的,任何常用的无针式注射器也与其类似。
目前已对无针式注射器进行了改进,即使用可行的小力量的储能机构。使用小力量的储能机构减少了对无针式注射器结构设计的限制。小力量的储能机构在诸如疫苗,特别是DNA疫苗之类的皮内应用中也很有用,因为力量大的储能机构可能破坏DNA疫苗中的分子结构。在“Intradermal DNA Immunization by Using Jet-Injectorsin Mice and Monkeys(在老鼠和瘊子体内使用喷射式注射器的皮下免疫),《疫苗》(Vaccine),17:628-38,1999年2月”一文中公开了这种应用。
因此,对于力量大的注射器和力量小的注射器来说,都需要在无针式注射器中使用改进的充药机构向注射器注药。
发明概述
根据本发明所述,设有一充药机构的注射器装置还具有一第一外壳部、一与第一外壳部滑动连接的第二外壳部、一限定一药液腔室的喷嘴组件、一在腔室近端部的第一位置和腔室远端部的第二位置之间的药液腔室内可移动的柱塞、一触发组件以及一能量产生源,该能量源可拆卸地与该触发组件连接,从而使触发组件的移动可触动能量源向近端部移动柱塞,并从药液腔室排出药液。该充药机构包括一可滑动地与第一和第二外壳部结合在一起的药筒,并在第一端部设有一挡块,并于第二端固定到第一或第二外壳部中的其中之一上。充药机构还包括一药筒止动件,该止动件与第一或第二外壳部中的其中另一个固定,并可与药筒的挡块在啮合点啮合,在柱塞移动到药液腔室的第二位置时可阻止药筒的移动。从第二外壳部移开第一外壳部可把柱塞移向远端部,使药液注入药液腔室,而向第二外壳部移动第一外壳部可把柱塞移向近端部,从药液腔室排出药液。
该注射器即可以是小力量的注射器,其操作压力大约小于4000psi,也可以是大力量的注射器,其操作压力大约大于4000psi。
在一实施例中,喷嘴组件与第一外壳部可移动地连接。能量产生源优选包括一螺旋弹簧。螺旋弹簧可设置在药筒内部。为了改变注入药液腔室的药液量,药筒止动件可包括一可改变啮合点的可调整圆环。
优选地,药筒与第二外壳部固定,而药筒止动件与第一外壳部固定。该注射装置还可包括一用于把药筒止动件固定到第一外壳部的螺钉、一位于第一外壳部的螺丝孔以及一位于药筒止动件内的螺丝孔。第一外壳部的螺丝孔与药筒止动件的螺丝孔对齐,与该螺钉螺接。
一推杆优选从柱塞延伸,并设于药筒内部。该推杆在第一端部还包括一惯性块,该惯性块与设于第一外壳部内的推杆止动件结合在一起,可阻止推杆从第一外壳部推出。
附图简要说明
图1是设有根据本发明所述充药机构的无针式注射器的横剖视图,其中注射器处于锁定状态;
图2是设有根据本发明所述充药机构的无针式注射器的横剖视图,其中注射器处于开锁状态;
图3A是一侧视图,表示设有根据本发明所述充药机构的无针式注射器,其中注射器处于锁定状态;
图3B是一侧视图,表示设有根据本发明所述充药机构的无针式注射器,其中注射器处于开锁状态;
图3C是一侧视图,表示设有根据本发明所述充药机构的无针式注射器,其中注射器与药瓶连接;
优选实施例说明
如图1和2所示,一无针式注射器10包括一第一外壳部12、一第二外壳部14以及连接第一和第二外壳部12和14的药筒16。在第一外壳部12的一端安装一喷嘴组件18。喷嘴组件18可用螺纹连接到第一外壳部12,使其可易于安装和拆卸。另一方面,也可使用其它用于安装或连接两个部件的公知结构,把喷嘴组件18可拆卸地装配到第一外壳部12上。在此结构中,可再次使用与各种喷嘴组件装配在一起的无针式注射器10。这种结构的一个优点是无针式注射器10可与可拆式喷嘴组件一起使用。在第二外壳部14上设有一触发组件20。触发组件20启动并触发一迫使药液喷出喷嘴组件18的能量源22。尽管图示能量源22是一螺旋弹簧,但也可使用诸如气压弹簧、气体推进器之类的其它产生力量的装置作为能量源22。
喷嘴组件18包括一具有一适当直径的开孔26的喷嘴本体24,该开孔在给定的理想压力范围和注射深度下产生药液的喷射流束。开孔26可以是任何形状的开孔,包括直线的、会聚性的、散开的、会聚-散开的等等。喷嘴组件18也设有一圆筒形腔室28,该腔室的终端为指向开孔26的锥体。如下面更详细说明的那样,使用注射器10时,药液装入到腔室28中,并从腔室28中注射出来。所述锥体可以是凸形的锥体(如图所示)、一正园形锥体,或者是任何其它合适的形状。一其压力壁与腔室28的锥体轮廓相符的柱塞30可滑动地设置在腔室28内部。例如,如美国专利US5062830所述(其公开的内容在此参照引用),柱塞30可包括诸如一O-形圈或者环绕其外部周边形成的类似结构的密封件32,以便进行密封,或者柱塞本身可以是一密封件。柱塞30还包括设于空隙间隔处的辅助密封件,以便进行更好地密封。
柱塞30与同能量源22连接的推杆34连接。或者如果需要的话,可使推杆34与储能结构形成为一整体。一惯性块36与最靠近柱塞30的推杆34端部附近的推杆连接,或者与其形成为一整体。惯性块36可以可移动地与推杆34连接,从而可调节该惯性块,以适应不同形式的注射,例如,考虑到药液的粘度、所需形成的初步压力、能量源22的强度以及注射穿透的深度等等。惯性块36与推杆止动器38共同限定推杆34可能向喷嘴组件18移动的距离。该特征的重要性在于其安全方面,即在没有喷嘴组件18时,如果注射器10还要注射,不会有抛射推杆34的危险。
触发组件20包括一设有一触发啮合凹槽42的触发伸缩件40。触发伸缩件40例如通过螺纹连接安装在推杆34的端部。触发组件40还包括一固定安装在药筒16上的碰锁套筒44。碰锁套筒44设有一加工而成的贯穿孔,以使伸缩件40穿过。碰锁套筒44进一步设有加工而成的多个侧壁孔46,以使滚珠或滚珠轴承48穿过。如图所示,一设有一开口端和一封闭端的管状按钮50镶入式地与碰锁套筒44设置在一起。按钮50具有一在其内壁54上形成的环状或环形凹槽52,使触发组件20在其图2中所示的注射位置时,可使滚珠48的一部分与凹槽52啮合。如图2所示,滚珠48的这种设置,即使其与碰锁套筒44的内侧壁表面56基本上平齐,从而使触发伸缩件40穿过碰锁套筒44。一碰锁滚珠保持杯58镶入式地设置在按钮50内。在杯58和按钮50之间设有一压缩弹簧60,使按钮50和杯体58在轴向方向上彼此偏离。
图2和3A表示处于解除或开锁状态的注射器10,即第一外壳部12和第二外壳部14处于在操作上彼此无关联的状态,从而可触发能量源22,迫使药液射出喷嘴组件18。图1和3B表示处于备用或上锁状态的注射器,即第一外壳部12和第二外壳部14处于在操作上彼此关联的状态,从而可触发能量源22,迫使药液射出喷嘴组件18。
通过简单地移动第一和第二外壳部12和14,使其靠在一起,可使注射器10从图2和图3A所示的开锁状态形成图1和图3B所示的上锁状态。具体说来,在第二外壳部14移向触发伸缩件40时,就向外推动碰锁保持杯58,使滚珠48与设置在触发伸缩件40上的触发啮合碰锁42啮合。压缩弹簧60向外推动按钮50。滚珠58被锁定在碰锁42和按钮50内侧壁54之间,把推杆34锁定到触发组件20上。一旦触发伸缩件40锁定到碰锁套筒44上,第一外壳部12移动靠近第二外壳部14,进一步压缩能量源22。
尽管把触发伸缩件40锁定到了碰锁套筒44,第一外壳部12仍可沿药筒16的长度方向自由滑动。在第一外壳部12沿药筒16移动时,柱塞30相对于圆筒形腔室28移动。如果在注射器10处于图3C所示的上锁状态时,把喷嘴组件18连接到装有药液的药瓶62上,则朝第二外壳部14的方向抽动柱塞30,把药液抽入腔室28。图3C表示喷嘴组件18通过接合装置64连接到药瓶62上。可使用任何与喷嘴组件18匹配的结构作为接合装置64。例如,Lilley等人的美国专利US5599302、Sadowski等人的专利US5769138以及Dunlap的专利US4507113中公开的接合装置就是可接受的结构实例,上述专利文献的内容在本文中参考引用。为了排除腔室28内的任何空气气泡,可向第一外壳部12移动第二外壳部14。在从喷嘴组件18拆下接合装置64之前或之后都可以这样做。
在药筒16最靠近第一外壳部12的端部设有挡块66。挡块66与药筒止动件68结合,一起防止第一外壳部12完全滑出药筒16。定位螺钉70把药筒止动件固定到第一外壳部12上。由于挡块66和药筒止动件68限定了柱塞30相对于腔室28的移动量,挡块66和止动件68因而也限定了注入腔室28的药液量。因此,如果药筒止动件68是一可调整的圆环,就可调整第二外壳部14在药筒16上的移动量,进而可计量药液的变化量。
如果注射器10使用力量很大的能量机构,那么人们需使用一般的力量才可压住能量机构,并推动第一外壳部12靠近第二外壳部14。对于具有最小力量的人来说,可使用备用位置来锁定注射器10,该位置包括两个接收开锁注射器10并在马达供电时可移动的彼此间隔开的表面。如果注射器10使用力量很低的能量机构,即便是那些最小力量的人也能推动第一外壳部12靠近第二外壳部14。
虽然本文公开的发明所说明的实施例很显然可实现上述目的,但可以理解,对于本领域的技术人员来说可以设计出多种改进和其它实施例。因此可以明白,附属的权利要求书在本发明的精神实质和保护范围内,意在涵盖所有的这些改进和实施例。

Claims (12)

1、一种设有一充药机构的注射器装置,其中所述注射器装置具有一第一外壳部、一与第一外壳部滑动连接的第二外壳部、一限定一药液腔室的喷嘴组件、一在腔室近端部的第一位置和腔室远端部的第二位置之间的药液腔室内可移动的柱塞、一触发组件以及一产生能量的能量源,该能量源可拆卸地与该触发组件连接,从而使触发组件的移动可触动能量源向近端部移动柱塞并从药液腔室排出药液,所述充药机构包括:
一可滑动地与第一和第二外壳部结合在一起的药筒,所述药筒在第一端部设有挡块,并于第二端固定在第一或第二外壳部中的其中之一上;
一药筒止动件,该止动件与第一或第二外壳部中的其中另一个固定,并可与药筒的挡块在啮合点啮合,在柱塞移动到药液腔室的第二位置时可防止药筒的移动,
从第二外壳部移开第一外壳部可把柱塞移向远端部,使药液充入药液腔室,而向第二外壳部移动第一外壳部可把柱塞移向近端部,从药液腔室排出药液。
2、如权利要求1所述的注射器装置,其特征在于喷嘴组件与第一外壳部可移动地连接。
3、如权利要求1所述的注射器装载,其特征在于能量产生源包括一螺旋弹簧。
4、如权利要求3所述的注射器装置,其特征在于螺旋弹簧设于药筒内。
5、如权利要求1所述的注射器装置,其特征在于药筒止动件包括一可改变啮合点的可调整圆环,从而可改变灌入药液腔室的药液量。
6、如权利要求1所述的注射器装置,其特征在于药筒与第二外壳部固定,而药筒止动件与第一外壳部固定。
7、如权利要求6所述的注射器装置,其特征在于还包括一用于把药筒止动件固定到第一外壳部的螺钉、一位于第一外壳部的螺纹孔以及一位于药筒止动件内的螺纹孔,该第一外壳部的螺纹孔与药筒止动件的螺纹孔对齐,以可螺接地接纳该螺钉。
8、如权利要求1所述的注射器装置,其特征在于一推杆从柱塞延伸,并设于药筒内部。
9、如权利要求1所述的注射器装置,其特征在于推杆在第一端部还包括一惯性块。
10、如权利要求10所述的注射器装置,其特征在于该注射器还包括设于第一外壳部内的推杆止动件,用于防止推杆从第一外壳部推出。
11、如权利要求1所述的注射器装置,其特征在于注射装置的操作压力大约小于4000psi。
12、如权利要求1所述的注射器装置,其特征在于注射装置的操作压力大约大于4000psi。
CN99811343A 1998-07-27 1999-07-26 用于药物注射器装置的充药机构 Pending CN1320050A (zh)

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