CN1374876A - 剂量设定限制器 - Google Patents

剂量设定限制器 Download PDF

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CN1374876A
CN1374876A CN00812954A CN00812954A CN1374876A CN 1374876 A CN1374876 A CN 1374876A CN 00812954 A CN00812954 A CN 00812954A CN 00812954 A CN00812954 A CN 00812954A CN 1374876 A CN1374876 A CN 1374876A
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driver
track
dosage
dosage setting
dose
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CN1183975C (zh
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彼得·克里斯蒂安·克利特伽德
斯特芬·汉森
伯·拉德默
克洛斯·施密特·默勒
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Novo Nordisk AS
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Abstract

一种防止设定超过注射装置的针筒内残留液体量的剂量的限制机构。该注射装置是由剂量设定部件相对于驱动器并远离注射装置内固定的止动件旋转而设定剂量的类型。剂量设定部件与驱动器相接,从而不用旋转驱动器而可以在一个方向旋转剂量设定部件。通过将剂量设定部件旋回而注射剂量,该剂量设定部件在向后旋转过程中带着驱动器。驱动器旋转导致活塞杆在针筒内向前移动,射出在针筒内的某些液体。驱动器设有其长度与针筒内的液体总量相关的轨道,该轨道被与剂量设定部件连接的轨道随动件啮合,以跟踪剂量设定部件的旋转。每次设定和注射剂量时,轨道随动件再移动进入轨道。当轨道随动件达到轨道的末端时,剂量设定部件再不能旋转,不能设定大于针筒内残留液体的剂量。

Description

剂量设定限制器
本发明涉及一种注射装置，其中针筒的内容物以多次单独设定的剂量来注射。
这种设备具有剂量设定机构，通过该机构，在启动注射按钮时为随后的注射设定剂量。这可以通过沿着活塞杆将托架移动与所需剂量成比例的距离然后将托架移动返回它的初始位置而实现，从而托架携带着活塞杆，而不是沿着所述活塞杆移动。
从EP327910中知道这样一种注射装置，它通过将螺母沿着有螺纹的活塞杆向上拧离开壳体中的止动件而设定剂量。通过按压形成注射按钮的螺母的端部，由此使得螺母部件移回而再次与止动件邻接，来注射该设定的剂量。在螺母的后一次移动中，活塞杆由螺母携带，该螺母在注射中相对于该活塞杆不移动。
在剂量设定时，如果设有一个限制器而使得一个超出留在针筒中的药剂的剂量设定不可能，这是很方便的。在EP327910中，这是通过活塞杆的螺纹具有的长度使得当螺母拧在螺纹的端部时并且然后压回原位至它与止动件邻接位置时针筒恰好是空的来实现。通过设定剂量，螺母只能被拧至螺纹的端部，因此最后的剂量的大小就被限制为包括针筒内的剩余量。
注射按钮必须移动的距离与针筒中的活塞必须移动以注射设定剂量的距离相对应。特别是具有大横截面直径的大针筒，该距离能够是非常短的。为了获得注射按钮的较大移动，可以使用一种齿轮，从而注射按钮必须移动的距离与注射剂量成比例而不是与针筒中活塞移动的次数成比例。
EP608343中描述了这种齿轮传动的剂量设定和注射机构的实施例。在这种设备中，托架不直接与有螺纹的活塞杆共同操作，而是与注射设定剂量时能移动活塞杆的驱动元件共同操作。在这种设备中，驱动元件包括螺母部件，它被固定而抵抗在注射设备中的轴向位移。螺母部件的螺纹与活塞杆的外螺纹相配合，该活塞杆被固定以抵抗在注射设备中的旋转。通过设定剂量，托架旋转离开止动件，当注射按钮被启动之后，它再返回止动件。在它返回过程中，托架旋转驱动元件，该驱动元件将活塞杆进一步移动进入针筒以压该针筒的活塞，从而针筒内药剂的设定量被通过在所述针筒的远端处的注射针头而压出。因为在剂量设定过程中螺母部件相对于活塞杆不移动，因此不能设置如上所述的限制机构来限定所述剂量使其不会超过留在注射装置中的液体量。
本发明的一个目的是提供一种限制机构，它防止设定一个超过齿轮传动型注射设备的针筒内留有的液体量的剂量，其中剂量是通过相对于驱动器并远离注射装置中的固定止动件而旋转剂量设定部件来设定的，该剂量通过将剂量设定部件旋转回而注射，该剂量设定部件在这个旋转操作中携带着驱动元件与它在一起，以旋转该将活塞向前移动的驱动元件。
本发明的这种机构特征在于，该驱动元件设有轨道，其长度与针筒内总的药剂量相关，并且该轨道通过与剂量设定部件相耦合的轨道随动件而啮合，以跟随所述剂量设定部件的旋转。随着在剂量设定过程中剂量设定部件和驱动器彼此相对旋转。在剂量设定过程中，轨道随动件会根据设定剂量而在驱动器的轨道内前进至一个位置。因为在注射过程中，驱动器跟随剂量设定部件的旋转，因此当注射设定剂量时，剂量设定部件的销会保持它在驱动器的轨道内的位置。该轨道的长度被调整为使得销到达轨道的末端并且当设定对应于针筒内剩余液体量的剂量时使得设定剂量不能增加。
根据本发明，该驱动器可以是盘状的，并具有螺旋形轨道，该轨道被与剂量设定部件柔性连接的部件上的凸轮所啮合，从而当销跟随驱动器的轨道时，该销可以径向移动。
在本发明的另一个实施方案中，驱动器可以是圆筒状，并具有螺旋形轨道，该轨道被与驱动器圆筒状同心的剂量设定部件上的凸轮所啮合。
该轨道可以被设置为驱动器内的螺纹，并且轨道随动件可以是与剂量设定部件相耦合的螺母形部件，该轨道随动件设有与驱动器的螺纹相啮合的螺纹。当设定剂量时，该剂量设定部件被利用它的螺纹沿着驱动器的螺纹拧紧。设定剂量的限制是通过使螺纹具有适当的长度而实现的。
以下，参考附图更详细的解释本发明。
图1表示具有本发明的剂量限制器的注射装置的分解视图；
图2表示图1中的注射装置的剂量设定元件和驱动元件的放大视图；
图3表示注射装置的另一实施方案的剂量设定元件、驱动器和轨道随动件。
图1中的注射装置包括容纳针筒2的外壳1，内容物由活塞杆3从该针筒压出，所述活塞杆借助于齿轮4和5前进与经过剂量设定而设定的剂量相对应的距离而注射。剂量设定部件6设置有围绕着中心孔的齿轮7，驱动器9上的小齿轮8通过该孔伸出，如图2所示。剂量设定部件6通过操作元件10来操作，该操作元件10具有手指夹(finger grip)11、啮合剂量设定部件6的托架12以及在位于形成为外壳1的一部分的盖15上的标尺14上指示的箭头13。图1还显示了帽25，它可以盖上以保护可能安装在注射装置上的未显示的针头，并显示了注射按钮16，它滑动安装在外壳1内并具有一凹槽17，凹槽在设置了榫18的侧面之一上。
在组装的注射装置中，剂量设定部件6上的齿轮7啮合按钮元件16上的榫18，而驱动器9上的小齿轮8与齿轮5的大直径部分啮合，其小直径部分与另一齿轮4啮合，齿轮4还与活塞杆3上的榫19相啮合。
驱动器9设有棘爪26，它与外壳内未显示的齿形成单向连接，使得驱动器9只能沿活塞杆3前进进入针筒2的方向旋转。通过与驱动器9周边的锯齿状榫27啮合的剂量设定部件6上的锯齿状突起而设置棘轮，该棘轮的取向使得只有剂量设定部件6沿着驱动器9能移动的方向的旋转被从剂量设定部件6传递给驱动器9。通过剂量设定部件6沿着相反方向旋转，棘轮部件的齿会相互压制。
为了设定剂量，操作元件10的打捞工具11被抓紧，并且元件10被顺时针旋转直至标尺14上的箭头指在所需要的剂量上。如上所示，该旋转会使得剂量设定元件的棘轮部件以及驱动器彼此相互压制。如果剂量设定部件6在逆时针方向旋转以减少设定剂量，棘轮会导致旋转从剂量设定部件6传递给驱动器9，但是当该方向的扭矩被从操作元件经托架12传递给剂量设定部件6，该剂量设定部件变形，从而剂量设定部件6上的突起从它与驱动器9的齿27的啮合中脱出，不经旋转被传递给驱动器9，剂量设定部件6就可以逆时针旋转。
由于剂量设定部件6上的齿轮7与注射按钮16的榫18之间的啮合，当剂量被设定时该按钮会从外壳1的端部升起，而当剂量被减少时该按钮会降低。
当注射按钮16被压下以注射设定剂量，剂量设定部件6上的齿轮7与注射按钮16的榫18之间的啮合会使得剂量设定部件6逆时针方向旋转。因为扭矩没有由操作元件10传递给剂量设定部件6，剂量设定部件6和驱动器9之间连接的棘轮会被启动，并且驱动器9会在逆时针方向随剂量设定部件6旋转，并驱动活塞杆3进入针筒。
如图2所示，盘状驱动器9在其面对剂量设定部件6的侧面内具有螺旋状轨道20，该轨道被设置在臂22端部的凸轮21所啮合，臂22被弹性梁23紧固在剂量设定部件6上，从而臂22可以摆动以使得凸轮21沿驱动器9的径向移动。当在剂量设定过程中剂量设定部件6相对于驱动器9旋转时，凸轮沿着轨道20移动，而在注射过程中，由于剂量设定部件6和驱动器9的伴随转动，凸轮保持在它在剂量设定过程中在轨道20内的位置。这样凸轮在轨道中的位置反映了给药的总量。当凸轮21邻接轨道20的端壁24时，设定的剂量不能增加，并且通过将轨道的长度调整至针筒内药的总量，确保了不能设定大于在针筒内残留的药量的剂量。
图3表示剂量设定限制器的另一实施方案的围绕驱动器31的剂量设定部件30。剂量设定部件30是圆筒状，在其外壁上设有螺旋状轨道29，该轨道被设计为与外壳内未显示的螺旋内脊一同操作，从而当旋转以设定剂量时剂量设定部件30向外拧，当旋转以减小过大的设定剂量时，该剂量设定部件30在所述外壳内向内拧。在剂量设定旋转中，剂量设定部件30相对于它围绕的驱动器31自由旋转。在剂量设定部件30和驱动器31之间，连接有螺母部件32，当其相对于驱动器31旋转时它能够被沿着该驱动器向上拧，该驱动器在其外表面上设有螺旋轨道33。螺母部件32在其外壁沿轴向设有凹槽34，该凹槽被在剂量设定部件30的内侧上沿着轴向的脊35啮合。
在剂量设定过程中，由于脊35和凹槽34之间的啮合，螺母部件32随剂量设定部件30相对于驱动器31旋转，从而螺母部件32在该驱动器上的位置依赖于剂量设定。当该剂量通过按压置于剂量设定部件30的端部36内的未显示注射按钮而被注射时，该按钮将驱动器31端部的凸缘37压成与剂量设定部件30所述端部36的按钮处的连接齿38相连接。在其下部不可见的侧面，凸缘37设有与剂量设定部件30的连接齿38相对应的连接齿，当剂量设定部件30由于剂量设定部件30内的轨道29与外壳内的脊之间的啮合而被强迫以在它被压进所述外壳内时相对于外壳旋转时，该旋转被传递给驱动器31，该驱动器31由于啮合连接齿而被强迫随着剂量设定部件旋转，在该旋转过程中，螺母部件32会保持在它在驱动器31上的位置。这样螺母部件32在驱动器31上的位置会始终指示设定和注射剂量的总和。当驱动器31内的螺旋轨道33的长度被调整至针筒内的药剂总量时，螺母部件32会到达轨道33的端部，并停止设定比针筒内残留药量大的剂量。

Claims (4)

1.一种限制机构，它防止设定超过注射装置的针筒内剩余液体量的剂量，其中通过相对于驱动器并远离注射装置内的固定止动件而旋转剂量设定部件来设定剂量，该剂量通过将该驱动器旋转返回而注射，在这种旋转过程中，该剂量设定部件带着驱动器一起旋转以旋转该将活塞杆向前移动的驱动器，其特征在于驱动器设有其长度与针筒内的药剂总量相关的轨道，该轨道被与剂量设定部件连接的轨道随动件啮合，以跟随该剂量设定部件的旋转。
2.如权利要求1所述的限制机构，其特征在于，驱动器为圆盘形，具有螺旋状轨道，该轨道被与剂量设定元件柔性连接的凸轮啮合，从而所述凸轮能够在它跟随驱动元件的轨道时径向移动。
3.如权利要求1的限制机构，其特征在于驱动器是圆筒状，具有螺旋状轨道，该轨道被与剂量设定部件连接的凸轮啮合，剂量设定部件是与驱动器同心的圆筒状。
4.如权利要求3的限制机构，其特征在于轨道设置成驱动器内的螺纹，轨道随动件是与剂量设定部件连接的螺母状部件并设有与驱动器的螺纹相啮合的螺纹。
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CN104470558A (zh) * 2012-04-10 2015-03-25 卡贝欧洲有限公司 注入装置
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CN104955505A (zh) * 2013-02-01 2015-09-30 诺和诺德股份有限公司 非轴向工作内含物排空机构和包括该非轴向工作内含物排空机构的注射装置
CN105102031A (zh) * 2013-04-10 2015-11-25 赛诺菲 用于药物输送装置的驱动机构
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CN105102031B (zh) * 2013-04-10 2019-01-18 赛诺菲 用于药物输送装置的驱动机构
US10478562B2 (en) 2013-04-10 2019-11-19 Sanofi Drive mechanism of a drug delivery device
CN105682709A (zh) * 2013-09-03 2016-06-15 赛诺菲 用于药物输送装置的驱动组件和包括驱动组件的药物输送装置
CN107106773B (zh) * 2014-12-08 2020-10-30 赛诺菲 驱动机构和具有该驱动机构的药物输送装置
CN107106773A (zh) * 2014-12-08 2017-08-29 赛诺菲 驱动机构和具有该驱动机构的药物输送装置
CN111295213A (zh) * 2017-11-07 2020-06-16 赛诺菲-安万特德国有限公司 具有剂量限制器的注射装置
CN112584884A (zh) * 2018-08-15 2021-03-30 赛诺菲 用于附接至注射装置的数据收集设备
CN113164688A (zh) * 2018-12-04 2021-07-23 赛诺菲 用于药物递送装置的组件、药物递送装置和用于生产药物递送装置的方法
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