CN1266720A - 用量设定设备 - Google Patents

用量设定设备 Download PDF

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CN1266720A
CN1266720A CN00106456A CN00106456A CN1266720A CN 1266720 A CN1266720 A CN 1266720A CN 00106456 A CN00106456 A CN 00106456A CN 00106456 A CN00106456 A CN 00106456A CN 1266720 A CN1266720 A CN 1266720A
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piston rod
axostylus axostyle
nut piece
consumption
mentioned
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拉尔斯·P·克里特姆斯
亨里克·安诺生
普雷本·B·尼尔森
约翰·T·汉森
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Novo Nordisk AS
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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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    • A61M5/3155—Mechanically operated dose setting member by rotational movement of dose setting member, e.g. during setting or filling of a syringe
    • A61M5/31553—Mechanically operated dose setting member by rotational movement of dose setting member, e.g. during setting or filling of a syringe without axial movement of dose setting member
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    • A61M5/31578—Constructional 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
    • A61M5/3158—Constructional 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
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    • A—HUMAN NECESSITIES
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    • A61M5/31535—Means improving security or handling thereof, e.g. blocking means, means preventing insufficient dosing, means allowing correction of overset dose
    • A61M5/31543—Means improving security or handling thereof, e.g. blocking means, means preventing insufficient dosing, means allowing correction of overset dose piston rod reset means, i.e. means for causing or facilitating retraction of piston rod to its starting position during cartridge change
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    • B—PERFORMING OPERATIONS; TRANSPORTING
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Abstract

采用一个用于供药系统的用量设定设备,其中一个活塞杆(6,9)连续把活塞(2)压入圆柱形的针剂瓶(1)中,相对于第一部分(6)转动活塞杆(6,9)的第二部分(9)来设定用量,这些部分用配合的螺纹来连接,使得活塞杆(6,9)的总长度随转动成比例地增加,以及在第二部分上的一个点(18)从相对于外壳(5)固定的停止位置上移开。当上述点(18)移回到停止位置时供给所设定的用量。第一部分(6)可以沿轴向移动但不能在外壳(5)中转动,第二部分(9)在轴向移动时也可以转动。把第一部分(6)保持成靠在活塞(2)上,把第二部分(9)连接成可被用量设定轮(20)转动。一个注射按钮(10)可在突出位置和压到底位置之间移动,并具有一个作用在第二部分(9)上的构件(13),把这个部分压到其停止位置上。

Description

用量设定设备
本发明涉及了一种用于供药系统之类的用量设定设备，其中，把一个包括第一和第二部分的活塞杆的端部连续压入含有药物的柱形针剂瓶的第一端中，把封闭上述针剂瓶第一端的活塞压入针剂瓶，从而通过装在针剂瓶第二端上的供药件把药压出，相对于上述活塞杆的第一部分转动活塞杆的第二部分来提供用量的设定，配合相关部分上的内外螺纹来连接上述两个部分，使得活塞杆的总长度增加一个距离，这个距离与相对于第一部分的第二部分转动程度成正比，并且依靠上述第二部分的转动，该第二部分上的一个点从相对于外壳固定的停止位置上移出，从而当上述点移回到停止位置时供给了所设定的用量，活塞杆的第一部分在外壳内被导向，使它可沿轴向移动但不能转动，远离活塞的活塞杆第二部分被安装成它在轴向移动时也可转动。
从EP 327 910已知一种设备，依靠增加包括活塞杆和活塞杆延伸区的活塞杆总长度，可用这个设备来设定用量，这里活塞杆靠在设备中针剂瓶的活塞上，而活塞杆延伸区通过螺纹连接与活塞杆结合。转动一个用量设定件来相对于活塞杆转动活塞杆延伸区，由此得到长度的增加，用量设定件可相对于外壳、从而也相对于活塞杆作转动。用量设定件和活塞杆延伸区之间的连接使活塞杆延伸区跟随着用量设定件的转动。由于活塞杆及其延伸区的总长度的增加，原先与外壳端对齐的活塞杆延伸区的外端通到外壳端之外。采用活塞杆延伸区的突出端作为注射按钮，可把它压到重新与外壳对齐为止。由此把活塞压入针剂瓶一个距离，该距离相应于活塞杆和活塞杆延伸区总长度的设定增加值。可重复这个设定和注射过程直到针剂瓶变空，以及活塞杆及其延伸区达到最大长度为止，此时整个设备被丢弃。
相似的用量设定设备可用作永久性的设备，其中，只是针剂瓶变空时用新瓶来置换。在可把新针剂瓶装入设备之前，需要把活塞杆的两部分拧在一起，以便把上述包括其延伸区的活塞杆总长度降低到因重复用量设定使长度被增加之前的原始长度。如上所述，必须用手把两个部分拧在一起，或者把螺纹作成具有超过活塞杆材料摩擦角的螺距，从而如果容许的话，在把两个部分相互沿轴向对压时，两个部分将相互作相对转动而拧在一起。也可把螺纹作成当把它们相互对压时，它们可脱开它们的相互配合。为了获得对存放针剂瓶空间的入口而移动设备外壳的一部分，由此可产生这种轴向对压。
对于EP 327 910中所述的设备，活塞杆端伸出注射器端之外一段与设定用量相应的距离。对于小用量这个距离可能非常小，小于1mm。希望注射按钮必须移动同样的距离而与将注射的用量无关。
在EP 245 312中描述了满足这个希望的设备。在此设备中，带有推杆的注射按钮在两个固定位置之间往复运动。当把注射按钮压到底时，推杆的长度使得推杆正好靠在针剂瓶的活塞上。如果在推杆处于其后退位置时把推杆的长度增加到与所设定用量相应的距离，则在下一次把注射按钮压到底时，将把活塞压入针剂瓶内一个与设定用量所提供的伸长相应的距离。在注射之后，推杆再次从活塞上后退。当针剂瓶变空时，推杆已被伸长到约为其原始长度的两倍，在把新针剂瓶装入设备之前，必须把推杆拧回到其原始长度。这种设备的缺点是：当完成注射和不再按压注射按钮时，要把推杆从活塞上脱开，因为由于活塞的弹性和由于针剂瓶内的压力，活塞可在针剂瓶内向后移动，由此使得刚注射的用量和下一次用量都不精确。
尽管至今给出的注射设备为自来水笔形状，但现在的趋势是指向较短的设备，宁可是大而较轻或小烟盒的形状。这种发展趋势的一个原因可能是针剂瓶具有较大的含量，用3毫升替代了以前的1.5毫升，它要求的笔直径已不可能再保持自来水笔形状。
尽管EP 327 910的设备上可设置柔性活塞杆来把它修改成短的设备，但EP 245 312的设备不适于这种修改，因为整个活塞杆及其延伸区必须在引导柔性杆的导向中作往复运动。尽管抵制柔性活塞杆通过活塞杆导向的阻力可作为防止活塞杆后退运动的障碍，但如果活塞杆要往复运动则这是不可取的，因为要依靠可克服上述阻力的复位弹簧来控制往复运动。当注射时，必须用一个力来按压注射按钮，这个力可同时克服导向中的阻力、弹簧力、以及把液体压出针剂瓶并注射它所需的力。
本发明的目的是提供一种适于短设备的用量设定设备。
这可由本申请说明中描述的设备来达到，本发明设备的特征在于：把活塞杆的第一部分保持靠在针剂瓶中的活塞上，活塞杆的第二部分连接到一个齿轮上，该齿轮与用量设定筒上的齿配合，当上述用量设定筒转动时转动活塞杆的第二部分，以及注射机构上设有一个注射按钮，它可在突出位置和压到底位置之间移动，该注射机构具有作用在活塞杆第二部分上的构件，当把注射按钮压到底时把第二部分上的点移到其停止位置上。
在本发明设备的一个实施例中，螺纹可以是不自锁的，可以锁定与用量设定筒齿配合的齿轮来制止相对于外壳的无意识转动，可用作为注射机构一部分的提升件表面的一个极限位置来确定停止位置，该提升件可在两个固定的极限位置之间作往复运动，可把活塞杆第二部分的上述点确定为该活塞杆第二部分一端的端点，该端点靠在上述表面上形成一个转动支点，活塞杆的第二部分可绕着它作转动，如果对该转动不锁定的话。
当连接两个活塞杆部分的螺纹不自锁时，如果容许它们相互作相对转动，则可把两部分压在一起。但是，第一部分不能相对于外壳作转动，并且因为第二部分带着一个齿轮，齿轮与带齿的用量设定筒的齿配合，而用量设定筒又被锁定成制止相对于外壳的无意识转动。因此除非采取专门的措施，两个部分不能作相对转动。采取一个能在两个固定极限位置之间往复运动的注射件，来保证每次按压注射按钮时注射件移动一个不变的距离。当该注射件处于注射按钮压到底时所确定的极限位置时，注射件的表面确定了停止位置，当注射按钮压到底时把活塞杆第二部分的一个点移到该停止位置上。上述点是活塞杆第二部分外端上的端点，该端点靠在上述表面上形成了一个转动支点，活塞杆第二部分可绕着它作转动，如果该转动不被锁定的话，由此保证了活塞杆或者把轴向力从活塞杆的一端传到另一端，或者它的两部分将转动，从而把两部分拧在一起并缩短了活塞杆的工作长度。如果自动地转动用量设定筒来设定用量，则活塞杆的第二部分相对于第一部分作转动，根据相对转动来改变活塞杆的长度，因为可通过齿轮把用量设定筒的转动传到活塞杆第二部分上。
按照本发明设备的一个实施例，一个来自盖住针剂瓶盖子的连接件可迫使活塞杆离开活塞，松开用量设定筒的转动，以及朝着上述提升件的表面移动活塞杆第二部分，使得在打开盖子时该第二部分的上述端点靠在上述表面上。当活塞杆的第一部分从活塞离开时，将把螺母件压向上述提升件的表面，并且由于螺纹不是自锁和由于活塞杆的第二部分可自由地转动，螺母件将引起上述活塞杆第二部分的转动，由此螺母件被移到上述活塞杆第二部分的另一端，准备新一轮的用量设定和注射。
在本发明设备的一个优选实施例中，螺纹可以是自锁的，由固定在外壳上的梁来确定停止位置，固定在活塞杆第二部分上的一个构件可以靠在该梁上，可把螺母件设计成其螺纹能脱开与活塞杆第二部分螺纹的配合。
自锁螺纹可具有比不自锁螺纹小的螺距，较小螺距的螺纹给出更精确的用量设定。采用自锁螺纹，在螺母件沿着活塞杆第二部分移动时不可能依靠该部分的转动，螺母件必须脱开与活塞杆第二部分螺纹的配合，使它沿着上述第二部分移动而不使该部分转动。来自盖住针剂瓶盖子的一个连接件在打开上述盖子来置换空针剂瓶时，就适当地引进了这个动作。
为了得到上述连接的脱开，该螺母件可具有两个相交的孔，其中一个孔具有与活塞杆第二部分外螺纹配合的内螺纹，另一个孔是光孔，滑动地与活塞杆第二部分的螺纹相配，螺母件可倾斜地装在活塞杆的第一部分上，使得在用量设定和注射期间，带螺纹的孔与活塞杆第二部分同心，在活塞杆后退期间，带螺纹的孔被上述连接件所倾斜，连接件作用在螺母件上，使光孔处于与上述活塞杆第二部分同心的位置上。
以下参照附图来更详细地描述本发明。其中：
图1示意地表示了一个带有本发明用量设定机构的注射器，它处于准备用量设定的状态，
图2表示了图1的注射器，它处于一次注射结束的状态，
图3表示了图1的注射器，它处于针剂瓶刚变空的状态，
图4表示了图1的注射器，它处于被打开来置换空针剂瓶的状态，
图5示意地表示了用量设定机构的另一个实施例的细节，
图6表示了沿图5中VI-VI线的剖视图，
图7表示了一个带着两个孔的可倾斜螺母件的剖视图，它处于带螺纹的孔与带螺纹的轴杆为同心的位置，
图8表示了图7中的螺母件，螺母件被倾斜到其光孔与轴杆同心的位置上。
在图1中，一个针剂瓶1被包含在注射设备的外壳5中，外壳5用虚线框表示，针剂瓶1的一端被活塞2封闭，另一端被图中未示的橡皮膜封闭，以容纳带有注射针4的针套3。
由柔性活塞杆来启动活塞，活塞杆包括了第一柔性部分6，它可作成弹性钢的紧密缠绕螺旋管。柔性部分6的一端通过活塞杆端头7作用在活塞2上，而另一端被图中未示的导向装置从第一端转了180°方向，并设有一个具有内螺纹开口的螺母件8。把一个有外螺纹的轴杆9引入该开口中，其螺纹与螺母件8开口中的内螺纹配合。该轴杆形成了活塞杆的第二部分。在螺母件8中转动轴杆9，由于改变了位于第一部分6延伸区上的活塞杆第二部分的部分位置，可改变活塞杆的总长度。
注射机构包括一个在带齿杆11一端的注射按钮10，一个齿轮12，以及一个具有带齿臂的提升件13，杆11的带齿区和提升件13臂的带齿区在沿直径对着的两侧被齿轮12所配合，齿轮12可绕着固定在外壳上的销作转动，由此把注射按钮10和杆11的向下运动转换成提升件13的向上运动，提升件13可压住轴杆9的外端，由此沿轴向压住活塞杆，使得该活塞杆迫使活塞2继续进入针剂瓶1中。当设备准备注射时，一个图中未示的弹簧将迫使注射按钮移到相对于外壳的图示突出位置上，而提升件移到最下端的位置。在注射时，可把注射按钮10压到底，与外壳5靠在表示为支撑件14的地方。图中未示的各个挡块确定了注射机构各零件的极限位置。这些极限位置用线15和16表示，分别表示了提升件13表面17的最下端和最上端的位置。线15和16之间的距离被标注为D。
在图1中，轴杆9的外端点18位于线16上，在上一次把注射按钮10压到底与外壳相靠时端点18被压到这个位置。现在可在螺母件8中向外拧轴杆9来设定用量，使得其端点16位于线15和16之间。由端点18和线16之间的距离来确定用量的大小，因为把注射按钮10压到底时端点18将移回到这条线上。轴杆上设有一个与用量设定筒20的内齿配合的齿轮19。筒有一个底21，它带着与盘22上径向压纹相应的径向压纹，由弹簧23把盘22压在筒20的底21上，压纹被设计成这样：当筒20转动一定的角度，例如相应于以一个单位改变一次用量设定时，各压纹相互超越而可听到咔嗒一声。可依靠筒的转动来设定用量。把该转动传到轴杆上，轴杆在螺母件8中向上拧动一个与用量设定筒20转动相应的距离。应注意到，在相反方向转动筒20可以减少过大的用量。
用电的方法来感应用量设定筒20的转动，并把它传到显示窗口，由此在显示窗口上的数字大小与用量设定筒20的实际大小无关，并可得到电子设定和显示的所有其它优点。
图2表示了注射一次用量之后设备呈现的状态，注射按钮10被压到底与外壳相靠。提供一个图中未示的锁定件把注射按钮10保持在这个位置上，直到它被再次释放为止，例如在用量设定筒20被使用时为止。另外在下一次注射之前设备被贮存起来时，也把注射按钮保持在这个压到底的位置上。
图3表示了与图2处于同样状态的设备，但在图3中，针剂瓶已变空，并且表示了一个新的构件24。该构件是活塞杆后退构件，它与托住针剂瓶的抽出件相连接。图4表示了当抽出针剂瓶作置换时，构件24如何朝着提升件的表面17移动螺母件。因为注射按钮被锁定在压到底的位置上，轴杆的尖端18靠在提升件的表面17上，因而提升件锁定在其图示的位置上。表面17和尖端18形成了一个转动支点，如果容许，轴杆可绕着它作转动。当针剂瓶抽出件被打开时，先把盘22从用量设定筒20的底21上脱开，由此用量设定筒20被设置成可自由转动。必须满足的一个条件是：轴杆9和螺母件8的配合螺纹是不自锁的，也就是说，螺纹的倾斜角大于带螺纹材料的摩擦角。
图5表示了本发明用量设定机构另一个实施例的细节。在该实施例中，形成活塞杆第二部分的轴杆25具有一个轴向孔，在孔的内壁上设有许多纵向槽26。把轴杆25拧入在活塞杆的柔性第一部分6端上的螺母件27中，由此把轴杆25分成一个形成活塞杆第一部分6延伸区的突出部分和一个位于螺母件27之后的部分。把上述位于螺母件27之后的部分可转动和可轴向移动地引导到一个开口中，开口在固定于外壳上的E形结构的梁29中。在轴杆25一端的法兰28限制了上述轴杆的轴向运动，从而也限制了它的可转动性，因为当轴杆25转动时，通过它与螺母件27的配合将沿纵向移动，直到法兰28或者靠在E形结构的中梁30上或者靠在该结构的下梁29上为止。
把一个大致呈圆柱形的转接件31插入突出上述轴杆端的端部。在转接件的外圆柱壁上有许多纵向键条37，它与轴杆25孔内壁中的纵向槽26配合，如图6所示，从而把转接件31的转动运动传到轴杆25上，而转接件31可在轴杆25内沿轴向移动。在转接件31的外端面上刻有压纹，与一个齿轮件32上相应的压纹配合，齿轮件32具有与用量设定筒20中内齿缘33配合的齿。一个销杆35从头到尾通过齿轮件32和转接件31中的轴向孔，在它突出齿轮件32的一端，以固定在上述销杆上的盘36来收尾。销杆通过轴杆25的孔和通过计数件38中的孔作延伸，计数件38装在大致呈圆柱形的套39上，套39插入带有法兰28的轴杆25端。套的外圆柱壁上设有许多键条40，与轴杆25中的槽26配合，从而上述套可沿轴向移动，但必须跟随着轴杆25的转动。计数件放在E形结构的中梁30和上梁41之间，并在其外壁上具有一个图中未示的装置，用于启动固定在外壳上的图中未示的触点或敏感元件，来监测计数件38的转动程度，因而也监测上述计数件必须跟随的轴杆25转动程度。销杆通过套39、计数件38和E形结构的上梁41作延伸，并在其上端作成齿形，与相应于图1-4中12的齿轮配合，使得销杆起着一个提升件的作用。依靠位于轴杆25孔中的弹簧42，把插入轴杆25相关端的构件，即转接件31和套39相互压开。由此把转接件31的压纹与齿轮件32的压纹相压配合，以及把计数件的端壁压到与E形结构的上梁41表面靠在一起。上述上梁41表面上设有突起43，它与计数件端壁中的相应凹陷44配合。当转动用量设定筒20来设定用量时，该筒的带齿内缘33将转动地驱动齿轮件32，由此通过转接件31把转动传到轴杆25上，除非轴杆处于其法兰28分别靠在下梁29或中梁30上并且转动沿着使法兰朝上述梁进一步移动的方向，此时由齿轮件32和转接件压纹表面形成的连接将因各压纹相互滑过而被释放，因为可克服弹簧42的力把转接件31压得离开齿轮件。由此避免了可能损害设备的转动力的传递。由于注射，将把法兰移动到靠在E形结构的中梁30上。从这个位置开始，拧动法兰离开上述中梁30来设定用量。法兰28和中梁30之间建立的距离决定了用量的大小，使法兰靠在上述E形结构下梁29上所需的转动决定了可设定用量的极限。
当轴杆25转动时，带着计数件38的套39将跟随着这个转动，在上梁41上的突起43将克服弹簧42的力从压住计数件38的凹陷44上滑出，直到突起遇到新凹陷作配合为止。突起和凹陷的周向间隔可使得连续配合产生的咔嗒声数目指示出所设定用量的大小。
当设定用量并且由此把法兰从E形结构的中梁30上离开时，按压设备的注射按钮朝着活塞杆端来拉动提升件，由此可进行注射。把齿轮件上的肩部45靠在轴杆25的端面46上，可启动形成活塞杆第二部分的轴杆25。在肩部45和端面46之间的间隙保证了在注射前或开始注射期间齿轮件32与带齿内缘33的配合被脱开。由此把用量设定筒设置成自由状态，从而在注射期间不会影响到用量大小。必须注意到，注射按钮必须具有这样的行程，它足以使得提升件把齿轮件32提升到脱离带齿内缘33，以及把轴杆移动到与可设定最大用量相应的距离。
螺母件27和轴杆25的配合螺纹是自锁的。这容许了较小的螺距和保证了更精确的用量设定。但是，必须采取措施来保证螺母件27的螺纹可与上述轴杆的螺纹脱开，从而在抽出空针剂瓶作置换期间抽回活塞杆来为新的满针剂瓶留出空间时，可从该轴杆的一端到另一端移动螺母件而不会使轴杆转动。
图7和8表示了具有第一和第二孔的螺母件27，孔的轴线相交成形成一个锐角，第一孔具有与带螺纹活塞杆25外径相应的直径，而仅在不为第一孔包括的第二孔的部位上，第二孔具有与上述活塞杆外螺纹47配合的内螺纹。
在用量设定和注射时，螺母件27处于图7所示的位置，其第二孔与轴杆25同轴，并且该孔中的螺纹48与上述轴杆25的螺纹47配合。如在螺母件27中向下拧动轴杆来设定用量，或者向上提升轴杆来注射已设定的用量时，则将力图绕着在活塞杆第一部分端部的图中未示的枢销，沿箭头49方向转动螺母件，该枢销与设在螺母件27上的轴颈50配合。如在与枢销沿直径对着的边上活塞杆后退件作用在螺母件上时，如箭头51所示，则螺母件将绕着支轴销倾斜，使第一孔处于与轴杆25同轴的位置。因为由于活塞杆抵制后退的阻力，活塞杆沿箭头52的方向作用在螺母件27上，使得螺母件27保持着倾斜的位置，从而在活塞杆后退期间可以滑过轴杆25上螺纹47的顶部。在图7和8中，虚线表示了不与轴杆同轴的孔。

Claims (3)

1.一种注射器，具有一个外壳，外壳包括一个针管架和设定用量的用量设定机构，由活塞杆将活塞逐步压入针管进行注射，上述用量设定机构包括带螺纹的轴杆和螺母件，螺母件与轴杆配合来设定用量，轴杆和螺母件的相对转动使螺母件沿轴杆移动，螺母件在轴杆上的位置确定注射时活塞杆前进的距离，其特征在于：螺母具有两个相互形成一角度的相交的孔，其中第一孔具有与轴杆外螺纹配合的内螺纹，第二孔是光孔并滑动配合在轴杆的螺纹上，螺母件在第一和第二位置之间可倾斜地安装到活塞杆上，在第一位置使螺纹孔在用量设定和注射时与轴杆同轴，当螺母受作用而倾斜到第二位置时，活塞杆后退、上述螺母件沿轴杆移动，光孔与轴杆同轴。
2.按照权利要求1的注射器，其特征在于：螺母件的第一侧铰接到活塞杆上，这样在螺母的一个方向上加一个力使活塞杆压到进行注射的方向，该加上的力使上述螺母件倾斜到它的第一位置。
3.按照权利要求2的注射器，其特征在于：活塞后退件作用在螺母件的与上述第一侧径向相对的第二侧上，在活塞杆后退力加到上述螺母件上时使螺母件倾斜到其第二位置。
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CA2294638C (en) 2007-08-14
BR9810039A (pt) 2000-09-05
WO1998057688A1 (en) 1998-12-23
DK0991442T3 (da) 2004-01-26
CN1165350C (zh) 2004-09-08
IL133250A (en) 2004-03-28
US6796970B1 (en) 2004-09-28
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ATE251925T1 (de) 2003-11-15

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