CN1441684A - 具有齿轮箱的注射装置 - Google Patents
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- A61M5/315—Pistons; Piston-rods; Guiding, blocking or restricting the movement of the rod or piston; Appliances on the rod for facilitating dosing ; Dosing mechanisms
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Abstract
一种注射装置，用于从筒中注射设定剂量的药剂，在该注射器中，剂量通过使螺母沿有螺纹的活塞杆向上拧而设定，而剂量设定鼓在它的柱形表面上有沿螺旋形的刻度，与设定剂量相对应的刻度数字显示在注射器的壳体的窗口中，从注射器端头升高的注射按钮沿轴向运动的距离大于螺母的轴向运动距离。在螺母和注射按钮之间形成齿轮传动。
Description
本发明涉及注射器，通过该注射器，能够通过旋转剂量设定件来设定剂量，且注射按钮能够从注射器的端头升高一定距离，该距离与该设定剂量成比例，且通过将注射器按钮压回其没有升高的位置处，可以注射该设定剂量。
在EP327910中介绍了一种几乎经典的该类型笔式注射器。
对该笔式注射器设定剂量时，形成注射按钮的管状件沿螺纹活塞杆向上拧一定距离，该距离与所述活塞杆在注射该设定剂量时必须移动的距离相同。该管状件只形成有螺母，该螺母在剂量设定过程中旋转离开止动器，且它在注射过程中压回成与所述止动器相抵，且施加在该按钮上的力直接传递给封闭注射器的安瓿的一端的活塞，该安瓿装有将注射的药剂。当活塞压入安瓿中时，药剂通过针头压出，该针头通过密封件安装在该安瓿的另一端处。
有时希望在该安瓿中能储存更大量，通常为3ml，而不是1.5ml。因为使该注射器更长并不合适，因此使该安瓿有更大的直径，即活塞对着安瓿中的药剂的面积将增大一倍，因此，为了在该安瓿内提供与以前相同的压力，施加在该活塞上的力将增大一倍。而且，活塞在注射一个单位的药剂时必须移动的距离减半。
该发展形式并不很有利，尤其是，手指力量较小的用户将很难压动注射按钮，当用更细的针以减小注射的疼痛时，还会增加问题。由于按钮的移动非常小，根本很难感觉该按钮是否移动，且当从3ml安瓿中注射一个单位时，活塞只需要移动大约0.1mm。
因此，希望在注射按钮和活塞之间有齿轮装置，这样，该按钮的冲程大于该活塞的冲程。通过该齿轮装置，注射按钮的移动量更大，需要施加在注射按钮上的力相应减小。
在EP608343中，通过使剂量设定元件沿具有较高节距螺纹的心轴向上拧，从而获得传动。当所述剂量设定元件沿其轴向压回时，该螺纹将使所述剂量设定元件旋转，该旋转通过联接器传递给具有细小节距的驱动器螺母，该驱动器螺母将驱使有螺纹但不可旋转的活塞杆向前运动。
在WO99/38554中提供了一种类似的传动，其中，在剂量设定鼓的外表面上切成具有较高节距的螺纹，该螺纹与在柱形壳体内侧上的匹配螺纹啮合。不过，对于该类型的齿轮装置，相互滑动的面积相对较大，这样，大部分的传动力由于滑动表面之间的摩擦而损失。因此，优选是采用齿轮和齿条相互啮合的传统齿轮装置。
由WO96/26754可知一种注射装置，其中，两个成一体的齿轮分别与固定在壳体中的齿条以及在柱塞内部的齿条啮合。当柱塞在壳体中轴向运动时，该柱塞内部的齿条能够驱动第一齿轮，以便使另一个成一体的齿轮沿壳体中的固定齿条运动。因此，齿轮沿柱塞运动方向运动，但是距离比该柱塞短，且该成一体的齿轮的轴向运动通过包围所述齿轮的壳体而传递给活塞杆，该活塞杆将安瓿的活塞进一步压入该安瓿中。不过，在柱塞内的齿条是在所述柱塞内部的多个轴向齿条。这些齿条与无齿的凹口交替，该凹口使得柱塞可以在第一齿轮不与该柱塞中的齿条啮合的情况下轴向运动，该结构使得柱塞能够在设定剂量时可以沿向壳体外的方向运动。当柱塞旋转以设定剂量时，在部件旋转的过程中，当第一齿轮经过没有齿的凹口时，它向外运动对应于一个单位的距离，然后，该第一齿轮与一个齿条啮合，从而能够注射设定单位的剂量，或者可以继续旋转，使得第一齿轮经过下一个凹口，在经过该凹口的过程中，设定剂量再增加一个单位，一直这样，直到设定了所希望的单位数目的剂量。
该结构的缺点是齿条和齿轮的齿必须交替继续彼此啮合和脱开，这必然有碰撞的危险。因为有间断的无齿凹口分开的几个齿条沿柱塞的内表面布置，在旋转360°时，只能有很小的增量。
本发明的一个目的是：提供一种注射装置，该注射装置有现有技术装置的优点，但是没有它们的缺点；以及提供一种装置，该装置中形成直接齿轮装置，即通过该齿轮装置，在注射按钮和活塞杆之间更多的是将旋转运动转变成线性运动，而避免将线性运动转变成旋转运动。
这可以通过一种注射装置实现，该注射装置包括：壳体，具有第一节距螺纹的活塞杆以不可旋转，但可纵向移动的方式在该壳体中进行引导；螺母，该螺母与该活塞杆的螺纹啮合，该螺母能够在该壳体中沿该有螺纹的活塞杆拧转离开确定位置，以便设定剂量，并且当注射该设定剂量时，能够带着该活塞杆一起按压返回所述确定位置；剂量设定鼓，该剂量设定鼓可以在壳体中沿第二节距的螺纹向外拧，以便使注射按钮与它一起从壳体的近端向上升高，本发明的注射装置的特征在于：提供有齿轮箱，该齿轮箱提供了在注射按钮和螺母相对于壳体的轴向运动之间的传动，该传动的传动比等于所述第二和第一节距比。
在一个优选实施例中，在注射按钮和螺母的运动之间的齿轮装置通过齿轮箱获得，该齿轮箱包括：至少一个齿轮，该齿轮安装在连接器上，该连接器可从该齿轮箱上进行纵向移动，但不能相对于所述齿轮箱旋转，且该连接器与螺母形成一体；第一齿条，该第一齿条与齿轮箱的第一元件形成一体，该元件可相对于壳体旋转，当不能相对于壳体纵向移动；以及第二元件，该第二元件装有第二齿条，该第二齿条可从所述齿轮箱上进行纵向移动，但不能相对于所述第一元件旋转，且该第二齿条与注射按钮联接，以便随所述按钮的纵向运动而运动，至少一个齿轮分别与该第一和第二齿条啮合，且该齿轮的尺寸为提供了这样的传动，即通过该传动，根据第二齿条和连接器相对于壳体的所述纵向运动的传动比，第二齿条的纵向运动转变成连接器的纵向运动，该传动比等于所述第二节距与所述第一节距之比。
在该装置中，驱动剂量设定鼓所需的力通过具有较高节距的螺纹转变，而使活塞运动进行注射所需的力通过普通齿轮传递给所述活塞，该齿轮有恒定啮合的齿轮和齿条。
活塞杆有止动器，用于螺母沿所述活塞杆的螺纹的运动。这样，以传统方式提供了剂量设定限制器，它不需要附加部件来防止设定的剂量超过能装在安瓿中的液体的量。
下面将参考附图更详细地介绍本发明，附图中：
图1是示意表示本发明的注射装置的剖视图；
图2是示意表示齿轮箱沿图1中的线I-I的剖视图；图3是表示本发明注射装置的另一实施例的剂量设定部分的纵剖图；
图4是垂直于图3的纵剖图；以及
图5表示了图3和4中所示装置的放大图。
在图1所示的装置中，细长的柱形壳体1有分隔壁2，该分隔壁2将壳体分成装有剂量设定机构的隔腔和设计成容纳未示出的安瓿的隔腔3。有螺纹的活塞杆4具有非圆形截面，因此，它穿过壁2中的中心孔2安装，这样，活塞杆4能够通过壁2中的中心开口纵向移动，但不能相对于该壁旋转。
壁2在其远离隔腔3的一侧延伸出一个与壳体1同心的管状元件5，该管状元件5在其邻近壁2的部分处有外螺纹6，且它的自由端处有一周向凹口7。齿轮箱9上的环形联接器元件8与该凹口7啮合。通过该联接器，齿轮箱9以使它能够在壳体内旋转，但不能相对于所述壳体轴向移动的方式固定在壳体1上。
在齿轮箱9中，包括两个成一体的齿轮的齿轮组件轴颈支承在轴11上，该轴11垂直于装置的纵向轴而在两轴向连接杆12之间延伸。该连接杆12从齿轮箱向分隔壁2伸出，并与螺母13相连，该螺母13邻近壁2，并与活塞杆4的螺纹啮合。齿轮组件包括：具有较大直径的齿轮14，该齿轮14与齿条15的齿啮合，该齿条15在齿轮箱中进行引导，以便沿装置的纵向方向移动；以及具有较小直径的齿轮16，该齿轮16与图2中的齿条10啮合，该齿条10沿装置的纵向方向在齿轮箱9的内壁上延伸。具有较小直径的齿轮16可以分成装于齿轮14的两侧的两个齿轮，在齿轮箱9的内壁上的齿条可以有纵向凹口，但没有齿，以便为齿轮14让出空间。
安装在壳体2中的管状剂量设定鼓17在一端处有与管状元件5的外螺纹6匹配啮合的内螺纹，且在它的另一端有具有放大直径的部分，该部分形成剂量设定按钮18。由于与螺纹6啮合，该剂量设定鼓17可以拧入壳体内和从该壳体中拧出，以便在该壳体1的未示出的窗口中显示在该剂量设定鼓17的外表面上的未示出螺旋刻度上的一个数字。
底部19成很深杯子形状的元件形成注射按钮，该元件有装入剂量设定鼓17中并包围齿轮箱9的管状部分20，且该元件形成注射按钮。在剂量设定鼓17和杯形元件之间的联接装置保证该剂量设定鼓20的旋转将传递给杯形元件。而且，管状部分20的内壁有纵向凹口22，该纵向凹口22与齿轮箱9上的凸起23啮合，因此，该剂量设定鼓17的旋转通过该杯形元件传递给齿轮箱9。
在该杯形元件的开口端的边缘处有瓣状V形齿，它的齿与在环25上的相应瓣状V形齿啮合，该环25通过弹簧26压靠在该杯形元件的边缘上，而该弹簧26在该环25的无齿侧和剂量设定鼓17的内壁上的圆形延伸肩部27之间压缩，该肩部27在该鼓的内螺纹的内端处。该环有内部耦合，该内部凹口与管状元件5上的纵向肋28啮合，这样，该环25可以沿装置的纵向方向移动，但不能相对于该壳体1旋转。因此，形成棘爪联接，当通过杯形元件旋转而使该杯形元件边缘处的V形齿越过环25的V形齿时将发出卡嗒声。
齿条15的凸出端的头部29在有一定游隙的情况下固定在该杯形元件的底部处，并在形成注射按钮的该底部19和靠近该底部19的内壁30之间。通过使该齿条的头部通过在底部19和头部29之间的弹簧31而压靠在壁30上，从而使该齿条固定就位。
为了设定剂量，剂量设定按钮18旋转，以便使剂量设定鼓17沿螺纹6向上拧。由于联接器21，杯形元件将随该剂量设定鼓17的旋转而旋转，并将与该鼓一起从壳体1的端部升高。通过杯形元件的旋转，在其开口端边缘处的V形齿24将越过不可旋转的环25的V形齿，以便在每单位剂量变化时发出卡嗒声。通过使剂量设定按钮18沿与增加剂量的方向相反的方向旋转，可以减少太高的设定剂量。当剂量设定鼓沿管状元件5的螺纹6向上拧时，环25将随着该剂量设定鼓的轴向运动而运动，因为弹簧26支承在肩部27上。弹簧将使环25和杯形元件的V形齿啮合，并保持联接器21的啮合，该联接器21可以包括Δ在杯形元件上的凸起32，该凸起32与剂量设定按钮18的内环33中的Λ形凹口啮合。
剂量设定按钮18和杯形元件的旋转通过在齿轮箱上的、与所述杯形元件的管状部分20的内壁中的纵向凹口啮合的凸起23而进一步传递给齿轮箱9。当设定剂量时，该齿轮箱25的旋转通过连接杆12传递给螺母13，这样，该螺母沿活塞杆4的螺纹向上拧，并升高离开它与壁2相抵的位置。当通过使螺母在活塞杆上运动而设定剂量时，该活塞杆操作在隔腔3中的未示出的安瓿中的活塞，通过使活塞杆4有一个限制螺母13沿该活塞杆4向上运动止动器35，能够很容易地形成剂量设定限制器，该限制器保证所设定的剂量大小不会超过能够装在该安瓿内的药剂的量。
由于头部29限制在杯形元件的底部19和壁30之间的空间内，齿条15与注射按钮一起向外拉。还有，螺母13相对于壳体1的轴向运动将通过连接杆12传递给齿轮组件，且它的运动将通过齿轮箱引起齿条15的向外运动。这样引起的向外运动必须与由注射按钮的向外运动引起的向外运动相同。这可以通过确定齿轮箱9的齿轮的尺寸而获得，这样，使连接杆12和齿条15相对于壳体的运动的传动比等于在活塞杆上的螺纹节距和使剂量设定鼓17纵向运动的螺纹6的节距之间的比。
为了注射设定剂量的药剂，通过按压按钮19而按压注射按钮。在按压的初始阶段，弹簧31被压紧，然后压力直接传递给齿条15的头部29，并同样传递给齿条15自身。该力通过齿轮箱9传递，并通过连接杆12传递给螺母13，该螺母13将使活塞杆4压入隔腔3中，直到剂量设定鼓17抵靠壁2。
在注射按钮运动的初始阶段中，杯形元件上的Δ形凸起32将脱开它与环33中的Λ形凹口的啮合。这时，该剂量设定鼓17再相对于注射按钮旋转，且当Δ形凸起32压靠在剂量设定按钮18的底部处的肩部34时也使该剂量设定鼓17相对于注射按钮旋转。只需要足以使剂量设定鼓旋转，以便使它自身沿螺纹6向下拧的力，因为进行注射所需的力通过齿轮箱9传递给活塞杆4。与剂量设定鼓同心的螺旋复位弹簧36可以安装在该鼓的底端，且该弹簧36的一端能固定在剂量设定鼓17上，另一端固定在壁2上。在设定剂量时，该弹簧可以卷得更紧，这样，它施加在剂量设定鼓上的扭矩近似等于克服在该剂量设定鼓沿螺纹6运动时的摩擦力所需的扭矩，这样，用户需要施加在注射按钮上的力只是驱动活塞杆进入安瓿以注射该设定剂量药剂所需的力。
应当知道，当只使用一个尺寸的齿轮时，该齿轮既与可相对于齿轮箱9运动的齿条15啮合，也与不能相对于齿轮箱9运动的齿条10啮合，这时对于活动齿条15和连接器12相对于注射器壳体1的纵向运动，可以提供2∶1的传动比，该连接器12装有齿轮的轴11。
图3和4表示了只用一个尺寸的齿轮的优选实施例，其中，与图1和2中的元件相对应的元件给出相同的参考标号，并加上前缀“1”。
为了制造原因，进行了很小的变化。因此，分隔壁102和管状元件105制成为两个部件，这两个部件通过装置的装配而彼此连接，以便使装配成的部件作为一个整体部件。同样，剂量设定鼓117和剂量设定按钮118制成为两个部件，它们牢固地固定在一起。
在管状部件105的自由端提供有作为外部凹口的周向凹口107，在齿轮箱元件109上提供有作为内部凸缘108的环形连接器元件，该内部凸缘与凹口107啮合，以便使该管状部件105和齿轮箱之间形成可旋转但不能轴向移动的连接。
有与齿轮箱上的凹口123啮合的脊122的管状元件120在其上端由按钮119封闭，通过按压该按钮提供的力通过该按钮传递给管状元件120。
齿轮箱由两个壳体形成，这两个壳体一起形成安装在管状元件中的柱体，其中，该壳体通过脊122和凹口123之间的啮合而进行引导。沿彼此相对的壳体的边缘提供有齿条110和115。形成齿轮箱部件109的一个壳体有与在中心管状部件105的端头处的周向凹口107啮合的内部凸缘108，并装有齿条110。另一外壳可在管状元件120中轴向移动，并形成齿条115。装有齿条115的壳体在它从齿轮箱中凸出的外端处有凸缘140，该凸缘140置于在装有按钮119的管状元件120的端头处的切口141中，该按钮和管状元件120能够向装置内部运动，这样，在按钮119抵靠凸缘140之前，能使齿132和133的啮合脱开。
管状连接元件112使有螺纹的活塞杆104与齿轮箱连接。该连接元件在它与活塞杆104啮合的端头处有螺母113，该螺母113有与活塞杆的外螺纹匹配的内螺纹。该连接元件在它与齿轮箱啮合的端头处有两个销钉111，这两销钉111在连接元件的两侧垂直于该连接元件112的纵向轴伸出。各销钉111装有齿轮114，该齿轮114布置成在两齿条110和115之间，并与这两齿条啮合。这样，当齿条110和115彼此相对旋转时，连接元件112将与齿轮箱一起旋转，而且能够相对于所述齿轮箱轴向移动。实际上，相对于齿轮箱元件109和壳体运动的使齿条115，且所述结构导致连接元件112相对于壳体运动的距离是齿条115运动的距离的一半。环125在它的外周有瓣状齿124，且该环125有中心孔，该中心孔套装在壳体101中的中心管上，这样，该环125可以沿所述中心管105轴向移动，但是在该环125的中心孔中的内部脊128与中心管中的纵向凹口137啮合，以便使该环不能在壳体中旋转，这样，当所述管状元件与剂量设定鼓117一起旋转时，在管状元件120边缘处的瓣状齿可以封盖在环的齿124上。在该环125和剂量设定鼓117中的内部肩部127之间起作用的弹簧126使得该环在管状元件120与剂量设定鼓一起在壳体中纵向移动时随该管状元件而运动。为了使剂量设定鼓容易旋转，尤其是当所述剂量设定鼓向内按压在壳体中时，因此提供有滚珠轴承，该滚珠轴承的外环142由肩部127支承，内环143支承一压力衬套144，该压力衬套144支承弹簧126。通过提供该光滑运转支承，当注射完设定剂量的药剂时，将剂量设定鼓117转回其零点位置只需要非常小的轴向力。该方法将代替提供复位弹簧，例如图1中的弹簧36。图中所示轴承为径向轴承，但是也可以由轴向轴承代替。
Claims (4)
1.一种注射装置，包括：壳体，具有第一节距螺纹的活塞杆以不可旋转，但可纵向移动的方式在该壳体中进行引导；螺母，该螺母与该活塞杆的螺纹啮合，该螺母能够在该壳体中沿该有螺纹的活塞杆拧转离开确定位置，以便设定剂量，并且当注射该设定剂量时，能够带着该活塞杆一起按压返回所述确定位置；剂量设定鼓，该剂量设定鼓可以在壳体中沿第二节距的螺纹向外拧，以便使注射按钮与它一起从壳体的一端向上升高，其特征在于：提供有齿轮箱，该齿轮箱提供了在注射按钮和螺母相对于壳体的轴向运动之间的传动，该齿轮装置的传动比等于所述第二和第一节距比。
2.根据权利要求1所述的注射装置，其特征在于：在注射按钮和螺母的运动之间的传动通过齿轮箱获得，该齿轮箱包括：至少一个齿轮，该齿轮安装在连接器上，该连接器可从该齿轮箱上进行纵向移动，但不能相对于所述齿轮箱旋转，且该连接器与螺母形成一体；第一齿条，该第一齿条与齿轮箱的第一元件形成一体，该元件可相对于壳体旋转，当不能相对于壳体纵向移动；以及第二元件，该第二元件装有第二齿条，该第二齿条可从所述齿轮箱上进行纵向移动，但不能相对于所述第一元件旋转，且该第二齿条与注射按钮联接，以便随所述按钮的纵向运动而运动，该至少一个齿轮分别与该第一和第二齿条啮合，且该齿轮的尺寸为提供了这样的传动，即通过该传动，根据第二齿条和连接器相对于壳体的所述纵向运动的传动比，第二齿条的纵向运动转变成连接器的纵向运动，该传动比等于所述第二节距与所述第一节距之比。
3.根据权利要求2所述的注射装置，其特征在于：通过使同一个齿轮与第一和第二齿条都啮合，从而使在注射按钮和螺母的运动之间的传动的传动比为2∶1。
4.根据权利要求1、2或3中任意一个所述的装置，其特征在于：该活塞杆有止动器，用于螺母沿所述活塞杆的螺纹的运动。
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| US9533106B2 (en) | 2011-12-29 | 2017-01-03 | Novo Nordisk A/S | Torsion-spring based wind-up auto injector pen with dial-up/dial-down mechanism |
| MX2014013842A (es) | 2012-05-31 | 2015-02-18 | Novo Nordisk As | Mecanismo de seleccion descendente para pluma giratoria ascendente. |
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| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| US9517311B2 (en) | 2004-10-04 | 2016-12-13 | Sanofi-Aventis Deutschland Gmbh | Drive mechanism for a drug delivery device |
| US9597460B2 (en) | 2004-10-04 | 2017-03-21 | Sanofi-Aventis Deutschland Gmbh | Drive mechanism for a drug delivery device |
| US10058659B2 (en) | 2004-10-04 | 2018-08-28 | Terumo Corporation | Drive mechanism for a drug delivery device |
| US10682468B2 (en) | 2004-10-04 | 2020-06-16 | Terumo Corporation | Drive mechanism for a drug delivery device |
| US11344678B2 (en) | 2004-10-04 | 2022-05-31 | Sanofi-Aventis Deutschland Gmbh | Drive mechanism for a drug delivery device |
| US11672915B2 (en) | 2004-10-04 | 2023-06-13 | Terumo Corporation | Drive mechanism for a drug delivery device |
| CN101115520B (zh) * | 2005-02-11 | 2010-04-21 | 诺和诺德公司 | 注射装置 |
| WO2013185379A1 (zh) * | 2012-06-14 | 2013-12-19 | 甘肃成纪生物药业有限公司 | 可调式注射笔 |
| CN105025957A (zh) * | 2013-03-14 | 2015-11-04 | 伊莱利利公司 | 用于自动注射装置的触发器组件 |
| CN105102018A (zh) * | 2013-04-10 | 2015-11-25 | 赛诺菲 | 药物输送装置的驱动机构 |
| US11554215B2 (en) | 2017-06-08 | 2023-01-17 | Novartis Ag | Injection device and injection solution transferring system |
| CN108404258A (zh) * | 2018-03-07 | 2018-08-17 | 梁楠 | 一种注射速度稳定的注射器 |
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