CN101208121B - 注射装置(可适配装置) - Google Patents

注射装置(可适配装置) Download PDF

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CN101208121B
CN101208121B CN2006800144069A CN200680014406A CN101208121B CN 101208121 B CN101208121 B CN 101208121B CN 2006800144069 A CN2006800144069 A CN 2006800144069A CN 200680014406 A CN200680014406 A CN 200680014406A CN 101208121 B CN101208121 B CN 101208121B
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CN101208121A (zh
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T·D·巴罗-威廉斯
D·埃丁顿
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Cilag GmbH International
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    • 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
    • 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
    • A61M5/20Automatic syringes, e.g. with automatically actuated piston rod, with automatic needle injection, filling automatically
    • 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
    • A61M5/20Automatic syringes, e.g. with automatically actuated piston rod, with automatic needle injection, filling automatically
    • A61M5/2033Spring-loaded one-shot injectors with or without automatic needle 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
    • A61M5/178Syringes
    • 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
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
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    • 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
    • A61M5/20Automatic syringes, e.g. with automatically actuated piston rod, with automatic needle injection, filling automatically
    • A61M2005/206With automatic needle 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
    • A61M5/178Syringes
    • A61M5/20Automatic syringes, e.g. with automatically actuated piston rod, with automatic needle injection, filling automatically
    • A61M2005/2073Automatic syringes, e.g. with automatically actuated piston rod, with automatic needle injection, filling automatically preventing premature release, e.g. by making use of a safety lock
    • A61M2005/208Release is possible only when device is pushed against the skin, e.g. using a trigger which is blocked or inactive when the device is not pushed against the skin
    • AHUMAN NECESSITIES
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    • 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
    • A61M5/32Needles; 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
    • A61M5/326Fully automatic sleeve extension, i.e. in which triggering of the sleeve does not require a deliberate action by the user
    • YGENERAL TAGGING OF NEW TECHNOLOGICAL DEVELOPMENTS; GENERAL TAGGING OF CROSS-SECTIONAL TECHNOLOGIES SPANNING OVER SEVERAL SECTIONS OF THE IPC; TECHNICAL SUBJECTS COVERED BY FORMER USPC CROSS-REFERENCE ART COLLECTIONS [XRACs] AND DIGESTS
    • Y10TECHNICAL SUBJECTS COVERED BY FORMER USPC
    • Y10TTECHNICAL SUBJECTS COVERED BY FORMER US CLASSIFICATION
    • Y10T29/00Metal working
    • Y10T29/49Method of mechanical manufacture
    • Y10T29/49826Assembling or joining
    • Y10T29/49904Assembling a subassembly, then assembling with a second subassembly

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Abstract

本发明公开了一种注射装置(110),包括外壳(112)和分配活塞(114),外壳适于容纳具有排放喷嘴(118)的注射器(116),分配活塞可在注射器中移动以将注射器的内容物通过排放喷嘴排出。还具有驱动器(130),适于作用在注射器上以将注射器从回缩位置推进到伸出位置,在回缩位置,排放喷嘴容纳在外壳中,在伸出位置,排放喷嘴从外壳中伸出。驱动联接器(134)从驱动器延伸至注射器的分配活塞,以将驱动器的移动传递到活塞上。驱动联接器包括定长驱动联接器和可更换驱动联接器。还公开了通过装配第一子组件(210)和第二子组件(220)制造注射装置的方法。

Description

注射装置(可适配装置)
技术领域
本发明涉及一种注射装置,这种类型的注射装置容纳注射器、使其伸出、排放其内容物并且之后使其自动回缩。
背景技术
如WO 95/35126和EP-A-0 516473所示的已知注射装置,倾向于使用驱动弹簧和一些类型的释放机构,该释放机构在注射器的内容物已经排出后,使注射器不再受驱动弹簧的影响,从而允许注射器通过复位弹簧回缩。
一般来说,这种注射装置需要强力驱动弹簧以便在注射器回缩之前可靠地排空注射器。当首先释放驱动弹簧时,弹簧先占据注射器中的空隙,然后使注射器和针头伸出,接着输送药物。弹簧弹力明显大于这些初始步骤所需要的力,并且多余的能量以由弹簧弹回产生的噪声和振动的形式放出。
一般而言,注射装置能够操作具有一定范围填充容量的注射器。当填充容量较低时,能够被占据的空隙较大,因此在致动时会有较大的噪声和较强的反冲。
因此,对于一定范围内的注射器填充容积,希望将噪声和反冲最小化以避免使病人受惊。
发明内容
设计本发明的注射装置以解决前述问题和其它事项。
考虑前述并根据本发明的第一方面,提供了一种注射装置,包括:
外壳,其适于容纳具有排放喷嘴和分配活塞的注射器,所述分配活塞在注射器中可动以将注射器的内容物通过所述排放喷嘴排出;
驱动器,其适于在致动时作用于所述注射器上,以将所述注射器从回缩位置推进到伸出位置,在所述回缩位置,所述排放喷嘴容纳在所述外壳中,在所述伸出位置,所述排放喷嘴从外壳中伸出;
驱动联接器,其从所述驱动器延伸至所述注射器的分配活塞,以便将驱动器的运动传递到活塞上,
其特征在于,所述驱动联接器包括定长驱动联接器和可更换驱动联接器。
对于注射器中给定容积的内容物,通过改变可更换驱动联接器的长度能够将由装置的致动所产生的噪声和振动最小化。
优选地,可更换驱动联接器包括刚性构件,该刚性构件被构造成与分配活塞以及定长驱动联接器相连接。
该刚性构件具有纵向轴线。
有利地,通过注射器在使用中排出的内容物的量来确定可更换驱动联接器沿其纵向轴线的长度。
通常,可更换驱动联接器的长度与注射器内容物的量成反比例。
在本发明的一种实施方式中,提供了一种可更换释放元件,其适于在活塞移动预定量之后从定长驱动联接器释放驱动器。
优选地,可更换释放元件是紧缩件(constriction),其适于作用在将定长驱动联接器连接到驱动器的至少一个臂上,由此从定长驱动联接器释放驱动器。
有利地,通过紧缩件的长度来确定活塞的预定移动量。
通常,紧缩件的长度与注射器内容物的量成反比例。
根据本发明的第二方面,提供了一种制造注射装置的方法,包括:
将具有活塞的注射器插入到第一子组件中;
将可更换驱动联接器插入到注射器中以接触所述活塞;
提供包括驱动器和定长驱动联接器的第二子组件;以及
将所述第一子组件和第二子组件装配在一起,
其中,在装配时,所述定长驱动联接器和可更换驱动联接器在使用中连通以将所述驱动器的移动传递到所述活塞上。
优选地,所述可更换部件具有纵向轴线且包括刚性构件,所述刚性构件被构造成与所述活塞和驱动联接器相连接。
在本发明的一种实施方式中,具有另外一个步骤,即,根据由注射器内容物的量确定的可更换驱动联接器的长度来选择可更换驱动联接器。
在本发明的另一种实施方式中,还具有下述步骤,在装配步骤之前将可更换释放元件连接到所述第一子组件上,其中,所述可更换释放元件适于在所述活塞移动预定量之后致动作用在定长驱动联接器上的驱动器中的延时机构。
优选地,根据由所述注射器内容物的量确定的可更换释放元件的长度来选择可更换释放元件。
附图说明
现在将参考附图示例性地描述本发明,其中:
图1示出根据本发明的注射装置的剖视图;和
图2示出图1中注射装置的局部放大图;
图3示出根据本发明的注射装置的部件分解图;以及
图4示出根据本发明的注射装置的子组件透视图。
具体实施方式
图1至4示出了注射装置110,其具有注射装置外壳112。外壳112的端部具有出口孔128,套筒119的端部能够从出口孔128中伸出。
外壳112容纳普通型皮下注射器114,该注射器114包括注射器主体116,该主体116限定储液器且一端终止于皮下注射针头118,另一端终止于凸缘120。注射器主体116沿着储液器长度的直径基本上是恒定的,而在接近注射器的终止于皮下注射针头的端部处直径明显较小。驱动联接器134通过注射器的塞子作用以将注射器114的内容物通过针头118排出。该驱动联接器134将待施用的药物124限制在由注射器主体116限定的储液器内。尽管图示的注射器是皮下注射型的,但这不是必需的。经皮的或冲击皮肤的以及皮下注射器也可以用于本发明的注射装置。
如图所示,注射器被容纳在注射器承载件150内。该注射器承载件150具有近端151,注射器的针头118穿过该近端151伸出。针头118通过针头子组件172连接到注射器的注射器主体116上,其中,该针头子组件172的直径逐渐减小。在注射器承载件150的近端151处,存在直径逐渐减小的部分173,该部分173将注射器114的端部支撑在注射器主体116上。注射器承载件150还包括一对挠性凸出部152。这对挠性凸出部152与复位弹簧支架160上对应的一对锁孔连通,使得注射器承载件150不能相对于复位弹簧支架160移动。注射器承载件150还包括接近其第二端的支承面153,复位弹簧支架160的对应支承面通过复位弹簧126偏压抵靠支承面153。通过复位弹簧支架160和注射器承载件150,复位弹簧126将注射器114从伸出位置偏压至回缩位置,在伸出位置,针头118从外壳112的孔128中伸出,在回缩位置,针头118容纳在外壳112内。
注射器承载件150包括护套154,注射器114能够从远端170插入到护套154中。注射器114设置有套管(未示出)。如果注射器出现故障或破裂,那么沿着注射器114的长度围绕注射器114的护套154将容纳注射器的碎片,并且降低这些碎片从注射装置110中漏出的可能性。
所述外壳还设有弹性闩锁构件161,其被偏压在与复位弹簧支架160上的锁定表面163接合的位置上。在与锁定表面163接合之前,闩锁构件161还穿过闩锁开口165伸入套筒119中。所述闩锁构件161包括倾斜面167,闩锁开口165的边缘以凸轮作用于凸轮随动件的方式作用抵靠在倾斜面167上。
所述外壳还包括致动器和驱动器,该驱动器在这里为压缩驱动弹簧130。驱动弹簧130的驱动经由多部件驱动器传递到注射器114的活塞上,以将注射器从其回缩位置推进到伸出位置,并且通过针头118排放其内容物。驱动器通过直接作用于药物124和注射器114上来完成该任务。驱动联接器134和注射器主体116之间的静摩擦起初就确保它们一起推进,直到复位弹簧126被压缩到底或注射器主体116遇到一些其它的阻止其移动的障碍物(未示出)为止。
驱动弹簧130和注射器114之间的多部件驱动器包括三个主要部件。驱动套筒131从驱动弹簧130处获得驱动力,并将其传递到驱动元件132上。这又将驱动力传递到上述驱动联接器134上。
驱动元件132包括空心杆140,该空心杆140的内腔形成与出口144连通的收集室142,该出口144从收集室延伸穿过杆140的端部。驱动联接器134包括盲孔146,其在一端打开以容纳杆140而在另一端封闭。可以看出,孔146和杆140限定流体储液器148,其中减振液容纳在该储液器148内。
在外壳112上远离出口孔128处设有扳机214。扳机在操作时用以将驱动套筒131从外壳112分离,允许驱动套筒131在驱动弹簧130的作用下相对于外壳112移动。以下描述装置的操作步骤。
首先,通过弹性闩锁构件161来阻止复位弹簧承载件152、从而阻止注射器承载件150和注射器114移动。通过将套筒119移入外壳112中,  闩锁开口165的边缘与闩锁构件161的倾斜面167接触,导致闩锁构件161向外移动,并因此与复位弹簧支架160脱离接合。一旦闩锁构件161从锁定表面163处释放,则注射器可以自由移动。
然后,按压致动器并释放驱动弹簧130。驱动弹簧130移动驱动套筒131,驱动套筒131移动驱动元件132,驱动元件132移动驱动联接器134。驱动联接器134移动,并且依靠静摩擦和作用于待施用的药物124上的流体静压力,克服复位弹簧126的作用来移动注射器主体114。注射器主体114移动注射器承载件150,该注射器承载件150又移动复位弹簧支架160,并压缩复位弹簧126。皮下注射针头118从外壳112的出口孔128中伸出。这持续到复位弹簧126被压缩到底或注射器主体116遇到一些其它的阻止其移动的阻碍物(未示出)为止。因为驱动联接器134和注射器主体116之间的静摩擦以及作用于待施用的药物124上的流体静压力不足以抵抗由驱动弹簧130产生的全部驱动力,此时驱动联接器134开始在注射器主体116内移动并开始排放药物124。然而,驱动联接器134和注射器主体116之间的动摩擦以及此时作用于待施用的药物124上的流体静压力和流体动压力足以使复位弹簧126保持其压缩状态,因此皮下注射针头118保持伸出。
在驱动联接器134到达其在注射器主体116内移动的终点之前,即,在完全排放注射器的内容物之前,连接第一和第二驱动联接器132和134的挠性闩锁臂到达连接在注射器承载件150的远端上的可更换释放元件155。
可更换释放元件155基本上是紧缩件,其将挠性闩锁臂移动到使这些臂不再将驱动元件132连接到驱动联接器134上的位置上。一旦上述情况发生,驱动元件132不再作用于驱动联接器134上,允许驱动元件132相对于驱动联接器134移动。因为减振液被容纳在由驱动元件132的端部和驱动联接器134中的盲孔146之间所限定的储液器148中,随着驱动元件132在受到驱动弹簧130的作用时相对于驱动联接器134移动,储液器148的容积趋于减小。随着储液器148缩小,使得减振液通过出口144流入收集室142内。因此,一旦释放挠性闩锁臂,由驱动弹簧130施加的一些力会作用在减振液上,导致其流过由出口144形成的紧缩件;剩余物通过流体并通过在第一与第二驱动联接器132、134之间的摩擦、由此经由驱动联接器134进行流体静力学作用。结果,驱动联接器134持续在注射器主体116内移动,且持续排放药物124。与减振液的流动相关的损失不会在很大程度上减弱作用在注射器主体上的力。因此,复位弹簧126保持被压缩,并且皮下注射针头保持伸出。
一段时间后,驱动联接器134完成其在注射器主体116内的移动,并且无法再继续移动。此时,注射器114的内容物完全被排出,并且通过由驱动弹簧130施加的力将驱动联接器134保持在其最终位置,并且持续使减振液流过出口144,允许驱动元件132继续移动。
在将储液器148中的流体用尽之前,连接驱动套筒131和驱动元件132的挠性闩锁臂到达外壳112中的另一个紧缩件。该紧缩件移动挠性闩锁臂,使得这些臂不再将驱动套筒131连接到驱动元件132上。一旦上述情况发生,驱动套筒131不再作用于驱动元件132上,允许它们相对于彼此移动。此时,不再将由驱动弹簧130产生的力传递到注射器114上。作用在注射器上的唯一的力是来自复位弹簧126的回弹力,该复位弹簧126通过复位弹簧支架160和注射器承载件150作用于注射器114的最接近针头118的端部。结果,注射器返回到其回缩位置并完成注射循环。
如图3所示,驱动联接器134包括定长驱动联接器134a以及可更换驱动联接器134b。可更换驱动联接器134b的长度能够通过更换不同的可更换驱动联接器来改变。可更换驱动联接器134b在其端部包括杯形件234,该杯形件234邻近定长驱动联接器134a且用于容纳定长联结器134a上的凸出部235。
通过改变可更换驱动联接器134b的长度来改变驱动联接器134的总长,从而改变驱动联接器134的近端240(最接近注射器114的排放针头118的一端)的初始启动位置(在致动扳机之前)。因此,能够将近端240的初始启动位置设置得尽可能接近注射器的内容物,即,注射器114的初始容积基本上能够对应于注射器内容物的体积。这样,能够将在首先释放驱动器130时必须占据的空隙最小化,由此降低注射装置110中的噪声和振动。
因此,注射器中液体的体积越小所需的可更换驱动联接器134a的长度越长。
由于驱动联接器134的长度可变,因此需要改变挠性闩锁臂不再将驱动元件132连接到驱动联接器134上的时间点,以确保注射器的内容物能够完全被排出。这可以通过改变可更换释放元件155的长度来实现。
驱动联接器134越长,需要可更换释放元件155越长。
可更换释放元件155设有挠性臂271,其用于在注射器承载件150上的切口281处将可更换释放元件155连接到注射器承载件150上。
如图4所示,为了便于制造,可以将注射装置110装配成两个子组件。
第一子组件210包括插入注射器114、注射器承载件150、可更换驱动联接器134b和可更换释放元件155。
第二子组件220包括注射装置110的外壳112、驱动元件和致动器,且包括定长驱动联接器134a。
这样,由于能够紧接在通过将第一子组件210和第二子组件220结合得到完整的注射装置110的最后组装之前改变可更换驱动联接器134b和可更换释放元件155的长度,因此能够独立于驱动元件(其难以装配)的构造来确定待插入到注射器中的内容物的量。
当然,应当理解的是,以上仅以示例的方式对本发明进行了描述,但是可以在本发明范围内对细节部分进行修改。

Claims (12)

1.一种注射装置,包括:
外壳,其适于容纳具有排放喷嘴和分配活塞的注射器,所述分配活塞可在注射器中运动以将注射器的内容物通过所述排放喷嘴排出;
驱动器;
驱动联接器,其从所述驱动器延伸至所述注射器的分配活塞,以便将驱动器的运动传递到活塞上;
其中所述驱动联接器包括定长驱动联接器和可更换驱动联接器;
其特征在于,所述驱动器适于在致动时作用于所述注射器上,以将所述注射器从回缩位置推进到伸出位置,在所述回缩位置,所述排放喷嘴容纳在所述外壳中,在所述伸出位置,所述排放喷嘴从外壳伸出;以及
所述注射装置还包括可更换释放元件,其适于在所述分配活塞移动预定量之后致动延时机构,所述延时机构位于作用在所述定长驱动联接器上的驱动器中。
2.如权利要求1所述的注射装置,其中,可更换驱动联接器包括刚性构件,所述刚性构件被构造成与所述分配活塞以及所述定长驱动联接器相连接。
3.如权利要求2所述的注射装置,其中,所述刚性构件具有纵向轴线。
4.如权利要求3所述的注射装置,其中,通过在使用中排出的注射器内容物的量来确定所述可更换驱动联接器沿所述纵向轴线的长度。
5.如权利要求4所述的注射装置,其中,所述可更换驱动联接器的长度与注射器内容物的量成反比例。
6.如前述任一项权利要求所述的注射装置,其中,所述可更换释放元件是紧缩件,其适于作用在将所述定长驱动联接器连接到所述驱动器的至少一个臂上,由此从定长驱动联接器释放驱动器。
7.如权利要求6所述的注射装置,其中,通过所述紧缩件的长度来确定所述活塞的预定移动量。
8.如权利要求7所述的注射装置,其中,所述紧缩件的长度与所述注射器内容物的量成反比例。
9.一种制造注射装置的方法,包括:
将具有活塞的注射器插入到第一子组件中;
将可更换驱动联接器插入到注射器中以接触所述活塞;
提供包括驱动器和定长驱动联接器的第二子组件;以及
将所述第一子组件和第二子组件装配在一起,
在装配步骤之前,将可更换释放元件连接到所述第一子组件上,其中可更换释放元件适于在所述分配活塞移动预定量之后致动延时机构,所述延时机构位于作用在所述定长驱动联接器上的驱动器中;以及
其中,在装配时,所述定长驱动联接器和可更换驱动联接器在使用时连通以将所述驱动器的运动传递到所述活塞上。
10.如权利要求9所述的方法,其中,所述可更换驱动联接器具有纵向轴线且包括刚性构件,所述刚性构件被构造成与所述活塞和定长驱动联接器相连接。
11.如权利要求9或10所述的方法,还包括根据由注射器内容物的量确定的可更换驱动联接器的长度来选择可更换驱动联接器。
12.如权利要求9所述的方法,还包括根据由所述注射器内容物的量确定的可更换释放元件的长度来选择可更换释放元件。
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