CN104147664B - 注射设备 - Google Patents

注射设备 Download PDF

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CN104147664B
CN104147664B CN201410424341.1A CN201410424341A CN104147664B CN 104147664 B CN104147664 B CN 104147664B CN 201410424341 A CN201410424341 A CN 201410424341A CN 104147664 B CN104147664 B CN 104147664B
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injection device
dose
dosage
tamper resistant
housing
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CN104147664A (zh
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克莱夫·尼科尔斯
罗伯特·迈克尔·伍森科洛夫
杰里米·马歇尔
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Owen Mumford Ltd
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    • A61M5/2448—Ampoule syringes, i.e. syringes with needle for use in combination with replaceable ampoules or carpules, e.g. automatic comprising means for injection of two or more media, e.g. by mixing
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    • A61M—DEVICES 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
    • A61M2205/00—General characteristics of the apparatus
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    • A61M2205/583—Means for facilitating use, e.g. by people with impaired vision by visual feedback
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    • A61M5/31525—Dosing
    • A61M5/31528—Dosing by means of rotational movements, e.g. screw-thread mechanisms
    • A—HUMAN NECESSITIES
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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

本发明公开了一种注射设备，所述注射设备包括计数轮(54)，所述计数轮在每次装置被启动时由剂量释放机构提供增量。该设备包括最终剂量禁止机构，其防止在最终剂量已经被释放时装置被进一步使用。提供防篡改装置以防止该设备的不利的或过早的初始化。

Description

注射设备
本申请是2012年6月4日进入中国国家阶段(国家申请号为201080054918.4)的国际申请日为2010年12月6日、发明名称为“注射设备”的国际申请PCT/GB2010/052033的分案申请。
技术领域
本发明涉及注射设备，尤其但不排他地涉及设计成允许经一段时间内将多种剂量从单个药筒或注射器释放的注射设备。
背景技术
在许多治疗中，药品需要每日地或以其它周期间隔来进行注射。这会存在潜在的问题，这是因为使用者可能不能清楚的记起他们是否已经接受了特定的剂量。因此在这种设备中需要提供增量计数器或一周中的日期的指示器，该指示器指示他们在特定时间段是否已经接受了该剂量。另外，在每次释放固定体积的剂量的情况下，非常期望能够在所有的可用剂量已经被从装置取走时给使用者发出信号，以防止使用者不利地接受零剂量或不足剂量。尽管可变剂量装置通常提供计数器显示以允许使用者拨入他们希望注射的药剂的单位数量，但是这些显示仅仅指示被释放的剂量的大小，并在完成注射时回零。所述显示没有指示剂量施加数量，即已经由装置进行的注射的累计数量。
在EP-A-1463550中，我们描述了用于具有剂量计数器构件的注射装置的剂量施加计数器，所述剂量计数器构件具有与剂量设定元件的空转连接(lost motionconnection)，以使得由于使用者在启动该装置之前设定了剂量体积的量，所以剂量施加计数器一个数一个数地被增加，而与构成该剂量的单位数量无关。虽然这是好的设计，但是其在设定剂量时而不是在剂量的实际释放时增加数字。因此，可能导致在使用者在设定剂量和释放该剂量之间分心的情况下剂量施加计数器表明该时间段的剂量已经被接受。另外，在该装置已经被启动以释放最终可用的剂量之后，剂量设定旋钮可能仍然被旋转而设定进一步的剂量，即使该装置的后续启动将不会释放适当的剂量也是如此。
发明内容
因而，我们已经设计了一种注射装置，其中计数构件响应于释放剂量的驱动构件的运动来提供增量，因此，该注射设备是通过剂量释放而不是通过剂量设定来提供增量。
在第一方面中，本发明提供了一种注射设备，所述注射设备包括：驱动装置，所述驱动装置能够致动以允许驱动构件运动，以便在每一次这种致动时释放剂量；和计数构件，所述计数构件驱动地连接至所述驱动构件，以通过每次剂量释放来提供增量。
在该结构中，累计剂量数可以通过由因使用而产生的不依赖于剂量大小的单一相同量来增加计数来保持。
虽然该运动可以是线性的，但是所述驱动构件优选安装用于旋转运动并旋转以释放剂量。于是，该驱动装置可以包括细长的驱动柱塞，所述细长的驱动柱塞与所述驱动构件螺纹接合并适于纵向前进以在所述驱动构件的相应的旋转运动时释放剂量。
存在多种方式以由合适的运动传递来使实际释放的剂量增量或行程或者对机构提供增量。例如，计数构件可以包括计数轮，所述计数轮具有与空转轮齿啮合的齿形面，所述驱动构件承载一个或多个轮齿以用于啮合空转轮齿，以在每次剂量释放期间为计数轮提供增量。虽然驱动构件轮齿可以与空转轮齿或计数轮自身连续地啮合，但是一旦每次剂量释放则所述驱动构件轮齿优选地与空转轮齿间歇地啮合。应当理解，在剂量释放周期过程中在任何时刻都可能出现增量，但是所述计数构件优选在该周期的部分获得增量。可选地，其它结构可以在剂量释放机构或其部件的运动用于在剂量释放过程中或结束时使计数器增加一个单位的情况下使用。这可以通过柱塞与计数器的相互作用或通过在剂量释放机构中的任意一个或多个部件之间的类似的相互作用来获得。
合适地，所述驱动机构包括：剂量设定元件，用于手动扭转以给与所述驱动构件相连的能量存储装置提供能量；和可释放触发器，用于将所述驱动构件保持在其被提供能量的状态和将所述驱动构件从其被提供能量的状态释放。
注射设备可以适合地包括最终剂量装置，所述最终剂量装置用于在所述驱动柱塞已经前进至最终剂量位置之后阻挡所述剂量设定元件的运动，因此防止进一步的剂量设定。
在所述驱动装置包括驱动传递元件，所述驱动传递元件与所述剂量设定元件一起旋转或与其一体形成，且所述驱动传递元件能够通过锁定装置连接至所述驱动构件的情况下，所述驱动传递元件和柱塞可以具有与其相连的相应邻接部，所述邻接部在驱动柱塞朝向其最终剂量位置前进时移动至阻挡结构，由此基本上防止剂量设定元件的旋转运动并因此防止进一步的剂量设定运动。
所述设备可以被设计成释放固定体积的剂量，或者其可以适于释放可调体积的剂量。
最终剂量禁止装置可以用在不具有剂量释放计数器的装置上。因此，本发明扩展到包括驱动装置的注射设备，所述驱动装置具有：
旋转驱动齿轮，所述旋转驱动齿轮与细长的带有螺纹的柱塞螺纹接合，以使所述细长柱塞前进以释放剂量；
旋转剂量设定元件，所述旋转剂量设定元件可对于从静止位置至被提供能量位置的偏置进行角运动，在所述被提供能量位置处，所述旋转剂量设定元件与所述旋转驱动齿轮锁定接合或与所述旋转驱动齿轮锁定在一起；和
触发装置，所述触发装置适于保持和释放驱动齿轮以用于旋转运动，
其中，与驱动柱塞和剂量设定元件相连的各个邻接部在所述细长的柱塞在连续的剂量之后前进至最终剂量位置时移动至阻挡结构，由此防止所述旋转剂量设定元件返回到其锁锁定的被提供能量状态。
邻接部可以包括在驱动柱塞上和在剂量设定元件上的相应的可配合的凸出部，所述凸出部协作以限制或抑制所述剂量设定元件的旋转。
在注射设备包括具有在致动以释放剂量之前在初始化步骤中相对于彼此移动所需的两个可相对运动的部分(例如，用于混合多成分药品或用于触发或预先准备装置)的壳体的情况下，注射设备可以包括防篡改装置以在释放防篡改结构之前防止所述相对运动。
所述防篡改装置通常可以包括可移去封装件，所述可移去封装件用于容纳所述设备的至少一部分并适于在除去所述封装件之前保持所述可移去部分抵抗初始化运动。
可选地，所述防篡改装置可以包括间隔元件，所述间隔元件被设置成防止所述初始化运动并可被从所述设备移除。
所述可移动的间隔元件可以包括撕扯带、撕扯标签，或可移动的间隔元件与所述壳体部分例如通过模制一体形成。
本发明还扩展至一种注射装置，所述注射装置包括具有在致动以释放剂量之前在初始化步骤中相对于彼此移动所需的两个可相对运动的部分的壳体，还包括防篡改装置以在释放防篡改装置之前防止所述相对运动。
本发明还扩展至一种注射装置，所述注射装置被设定或预先准备，且包括外部可视的指示器，所述外部可视的指示器显示在所述装置被设定或预先准备时颜色或其它可视特征的改变。
尽管上面已经对本发明进行了描述，但是本发明扩展至上面所列出的或在后续的说明书中、权利要求中或附图中的特征的任何创造性的组合。
附图说明
仅以示例的方式，本发明的多种实施例将在下文中参照附图详细描述，在附图中：
图1是根据本发明的实施例的注射装置在其作为供给形式、在壳体收缩以重构药品之前的立体图；
图2是类似于图1的视图，但是示出在重构药品之后且两种剂量被释放时的装置；
图3是图1和2的装置的前端上的细节视图，示出在前部位置处的套环；
图4是从装置的其余部分去除的驱动机构的视图，其中某些部分被去除；
图5(a)是驱动机构的分解图；
图5(b)和5(c)是驱动机构的细节视图；
图6是柱塞和棘轮驱动轴上的细节视图；
图7是柱塞的后端的细节视图；
图8是穿过棘轮驱动轴、驱动柱塞和驱动齿轮的剖视图；
图9至12是防篡改装置的多种实施例的视图，所述实施例需要在将壳体从如图1所示的其伸出位置移动至图2的位置之前被移动；
图13是另一种形式的抗篡改特征的细节视图；
图14是图13的装置的一部分的细节分解图；和
图15(a)至15(c)是细节视图，示出处在多个操作阶段的图13和14的防篡改特征。
具体实施方式
在附图中示出的注射装置的实施例被设计成与作为已知类型的双腔药筒中成未混合形式的两种成分供给的药剂一起使用，例如在申请人的在先申请WO2007/132191中所描述的。在供给时，药筒具有两个间隔开的塞子，所述两个间隔开的塞子限定两个独立的腔，且药品通过将后部的塞子向前驱动而被混合，以使得前部塞子向前移动以露出或打开旁通槽并此后迫使后腔中的流体进入前腔以与物质混合。在这种装置中，需要初始的纵向运动以重构药品，随后需要正常计量的剂量。在下面所述的实施例中，剂量全部是相同的体积，但是应当理解，装置可以容易地被修改成提供释放可变体积的剂量的能力。
参照图1，注射装置包括由后部10和前部12构成的壳体，所述前部12可伸缩地安装在后部的直径变小的位置上。驱动单元14被固定于壳体后部10的后端，并在其后端具有可旋转拨盘16，所述拨盘16被扭动以触发(cock)所述装置，致动按钮18向前滑动以启动所述装置。可旋转拨盘具有前部凸缘11，该前部凸缘位于驱动主体的外壳15的后缘13之下。该后缘除去三个透明的窗口17之外是不透明的。拨盘的凸缘11具有带颜色的块11’，带颜色的块11’设置成使得当拨盘16处在被触发位置时，带颜色的块11’与窗口17对准以显现颜色改变来方便表示。
在前部壳体12的前端处存在弹簧加载的套环20，所述套环20具有卡口互锁部，所述卡口互锁部允许所述套环被扭转和在弹簧21的作用下向前释放以露出检查窗口，通过所述检查窗口，药筒19的容纳物可以被观察到。套环20还在连接至药筒的前端处的螺纹部22时覆盖针头接口(未示出)。
在此，参照图4至图8，驱动机构将被更详细地描述。拨盘16固定于棘轮驱动轴24的后端以随之旋转。棘轮驱动轴在其前向端承载棘齿26(见图5(a)、5(c)和图6)，所述棘齿26与对应的、面向内的、在驱动齿轮32上的锁定齿或凹槽30配合(见图8)。扭簧34以其后端固定于拨盘16，并以其前端固定于固定的支撑套环36，所述支撑套环36固定于装置的壳体。棘轮驱动轴24在该固定的支撑套环36中自由旋转，但是被由棘轮驱动轴24所承载的外肋部37和承载于支撑套环36内的内肋部39的相互作用限制成旋转小于一圈。主体10具有一对内向花键(未示出)，所述内向花键与形成在柱塞44的螺纹部42中的对应的纵向沟槽40配合以保持柱塞不旋转，但是允许柱塞纵向移动。
驱动齿轮32围绕其表面以120°间隔承载有三对齿46，用于累加如下所述的剂量计数机构。在齿46的前方，驱动齿轮具有多个锁定凹槽48，所述锁定凹槽48与致动按钮18的前端上的锁定花键50配合。致动按钮18相对于壳体角度固定，而可在后部位置和前部位置之间轴向移动，在后部位置中，花键50与锁定凹槽48啮合以防止驱动齿轮旋转，在前部位置中，驱动齿轮被释放。
驱动齿轮承载螺纹孔52，所述螺纹孔52与柱塞44的螺纹部42螺纹啮合，并因此驱动齿轮的旋转以预设量推动柱塞前进。在柱塞上的螺纹和该螺纹孔是多线螺纹，例如4线螺纹。
在使用中，所述装置通过以下方式被触发或提供能量：将拨盘16扭转过三分之一圈以卷紧扭簧34和旋转棘轮驱动轴24，直至棘齿26锁定在驱动齿轮46上的相应锁定凹槽30中。在该位置处，驱动齿轮32被致动按钮上的花键50保持以防止旋转。在该条件下，状态的改变通过邻近拨盘16的窗口17中的颜色变化来表示。向前推动致动按钮18释放驱动齿轮32，以使得所述驱动齿轮在扭簧34的作用下与棘轮驱动轴24一起旋转以使柱塞44前进。
计数轮54借助于间隔开的安装板56与驱动齿轮32同心地安装，间隔开的安装板56也安装空转齿轮58，空转齿轮58与计数轮54的内部上的内齿条60啮合。板56相对于壳体角度固定，且随着驱动齿轮32旋转，齿46使空转轮齿58移动，所述空转轮齿58接着使所述计数轮以相同的增量旋转以记录剂量的释放和保持累计数。
如图7所示，柱塞后端形成有两个凸出部60，当柱塞到达其完全伸出位置时，两个凸出部60在棘轮驱动轴24的内侧上的凸出部62之间接合或移动，由此限制或防止棘轮驱动轴相对于柱塞进一步旋转。这不仅阻挡柱塞的进一步的向前运动，而且防止棘轮驱动轴相对于壳体旋转。这意味着拨盘16被锁定以防止在受到少量后冲时旋转运动。
如图1和2所示，为了使装置准备用于注射，壳体前部12需要向后滑动以被锁扣至后壳体10。为此，这使得柱塞作用于双腔药筒21中的后塞子(未示出)以进行药剂的混合。为了提供篡改显见特征(tamper evident feature)和防止不利的或过早的混合或重建，图1至图8的装置可以设置有防篡改结构。于是，在图9中，注射装置被包封在塑料或类似的可移除的半壳体72、74中，所述半壳体72、74提供凹槽76，凹槽76的相对的边缘可防止壳体前部和壳体后部的伸缩运动。
在图10中，独立的塑料部件76被围绕后壳体部分10被热熔，防止壳体部分的伸缩运动直至塑料部件移除为止。
在图11中，可剥离的粘接标签78被缠绕该装置以防止伸缩运动。
在图12中，端部模制的撕扯部80与前壳体12一体模制并被设计成被撕开。在前壳体的撕开部之间的邻接区域可以具有凹槽82以防止锋利的边缘被暴露。
再回到图13至图15，在该结构中，突出的腿状部84形成在后壳体部分10上并与壳体前部12的边缘中的成型槽86配合。在该结构中，槽86成型为具有凸轮表面88，腿状部84的前部在初始转动运动过程中骑在所述凸轮表面88上，以提供弹性定位动作(图15(a)至15(b))。在骑在凸轮表面88上之后，腿状部84的前部与槽86的主要部分对准，以使得壳体前部12可以伸缩地滑动回来以接触后壳体部分的相对的表面。腿状部84朝向其后端变宽，以使得在已经移动至如图2(图15(c))所示的伸缩位置之后，其不可逆地锁扣在槽中，因此其之后不能使壳体前部12向前滑动。

Claims (9)

1.一种包括驱动装置(14)的注射设备，所述驱动装置(14)具有：
旋转驱动齿轮(32)，所述旋转驱动齿轮与细长的带有螺纹(42)的柱塞(44)螺纹接合，以使所述细长柱塞前进以释放剂量；
旋转剂量设定元件(16、24)，所述旋转剂量设定元件对于从静止位置至被提供能量位置的偏置能够进行角运动，在所述被提供能量位置处，所述旋转剂量设定元件与所述旋转驱动齿轮(32)锁定在一起；和
触发装置(18)，所述触发装置适于保持和释放所述驱动齿轮以用于旋转运动，
其特征在于，与所述驱动柱塞(44)和所述剂量设定元件(16、24)相连的各个邻接部在所述细长的柱塞(44)在连续的剂量之后前进至最终剂量位置时移动至阻挡结构，由此防止所述旋转剂量设定元件返回到其锁定的被提供能量状态。
2.根据权利要求1所述的注射设备，其中，所述邻接部包括在所述细长柱塞(44)上和在所述剂量设定元件(16、24)上的相应的可配合凸出部(60、62)，所述凸出部协作以限制所述剂量设定元件旋转。
3.根据前述权利要求中任一项所述的注射设备，包括：
壳体，所述壳体具有在致动以释放剂量之前在初始化步骤中相对于彼此移动所需的两个可相对运动的部分(10、12)；和
防篡改装置(70、76等)，所述防篡改装置用于在释放所述防篡改装置之前防止所述相对运动。
4.根据权利要求3所述的注射设备，其中，所述防篡改装置包括可移去封装件(70、72)，所述可移去封装件用于容纳所述设备的至少一部分并适于在除去所述封装件之前保持所述可移去部分抵抗初始化运动。
5.根据权利要求4所述的注射设备，其中，所述防篡改装置包括间隔元件，所述间隔元件设置用于防止所述初始化运动并能够被从所述设备移除。
6.根据权利要求5所述的注射设备，其中，所述可移除的间隔元件包括撕扯带(76)。
7.根据权利要求5所述的注射设备，其中，所述可移除的间隔元件包括撕扯标签(78)。
8.根据权利要求5所述的注射设备，其中，所述可移除的间隔元件(80)与所述壳体的部分中的一个一体形成。
9.根据权利要求1所述的注射设备，还包括：
壳体，所述壳体具有在致动以释放剂量之前在初始化步骤中相对于彼此移动所需的两个可相对运动的部分(10、12)；和
防篡改装置(70、76等)，所述防篡改装置用于在释放防篡改装置之前防止所述相对运动。
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CN104147664A (zh) 2014-11-19
US8777899B2 (en) 2014-07-15
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JP2013512714A (ja) 2013-04-18
US9717856B2 (en) 2017-08-01
JP6148011B2 (ja) 2017-06-21
CN102648014A (zh) 2012-08-22
CN102648014B (zh) 2014-09-17
US20140228767A1 (en) 2014-08-14
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US20120296276A1 (en) 2012-11-22
EP2509664A2 (en) 2012-10-17

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