CN111544704B - 自动注射器中的力牵制 - Google Patents
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Abstract
一种用于从药筒的存储器输送药物物质的自动注射器,所述药筒在其远端处连接到针并在其近端处机械地联接到柱塞驱动器,所述注射器包括:连接部,其在所述药筒上;接触表面,其用于接触注射部位;框架,其连接到所述接触表面,所述框架具有:干涉元件,其具有远端止动部,所述干涉元件的尺寸设计为适于可滑动地联结到所述连接部并允许所述药筒滑动直到所述远端止动部;卡合元件,其允许所述干涉元件接纳所述连接部,但约束所述药筒使其不脱离连接;所述框架还包括驱动器安装部,其用于固定地装容柱塞驱动器,所述驱动器用于驱动柱塞通过所述针清空所述药筒的所述存储器,以将流体从所述存储器注射到所述注射对象中。
Description
本申请是2016年12月22日提交的发明名称为“自动注射器中的力牵制”的中国专利申请NO.201680083812.4的分案申请,该中国专利申请NO.201680083812.4是PCT国际申请PCT/US2016/068371的进入中国国家阶段的申请。
相关申请
本申请要求2016年1月21日提交的美国临时专利申请No.62/281,536的根据35USC§119(e)的优先权权益,其内容全文通过引用并入本文。
技术领域
本发明在其一些实施例中涉及一种自动注射器,且更特别地但非排斥性地涉及自动注射器中的力牵制。
背景技术
美国专利6500150、美国专利6824529、美国专利6843782公开一种药品输送装置,其具有:限定皮肤接触表面的基底构件;用作药品存储器的注射筒;和用于将药品从注射筒排出的结构。注射筒连接到基底构件,使得注射筒的纵向轴线大致平行于皮肤表面。输送针与注射筒连通。针具有成角度的弯曲部,该弯曲部将针的尖端大致垂直于皮肤接触表面引导。在使用时,针的尖端适于穿透对象皮肤。
对于这种相对较慢的释放,自动排出装置也已被提出。美国专利5858001公开一种液体药品输送装置,其通过基底构件粘接到对象皮肤,基底构件限定具有粘接涂层的皮肤接触表面。柱状药筒用作药品存储器,并被包含在连接到基底构件的壳体中,使得在使用时,药筒纵向轴线设置为大致平行于皮肤接触表面。当壳体相对于基底构件向下卡合时,在使用时与药筒内部连通的输送针穿透对象皮肤。这种动作还引起柠檬酸/碳酸氢钠气体发生器的致动,该发生器产生气体以移动药筒内的柱塞,压缩药品腔室。这种压缩使止动部被与输送针连通的导管穿透,以允许药品从腔室通过针喷射到对象的皮下组织中。
另外的背景技术包括美国专利No.6189292、美国专利公开物No.20130253434、美国专利公开物No.2009/093,792、美国专利No.7967795。
发明内容
示例1:一种用于从药筒的存储器输送药物物质的自动注射器,所述药筒在其远端处连接到针并在其近端处机械联接到柱塞驱动器,所述注射器包括:连接部,其在所述药筒上;接触表面,其用于接触注射部位;框架,其连接到所述接触表面,所述框架具有:干涉元件,其具有远端止动部,所述干涉元件的尺寸设计为适于可滑动地联结到所述连接部并允许所述药筒滑动直到所述远端止动部;卡合元件,其允许所述干涉元件接纳所述连接部,但约束所述药筒使其不脱离连接;所述框架还包括驱动器安装部,用于固定地装容柱塞驱动器,所述驱动器用于驱动柱塞通过所述针清空所述药筒的所述存储器,以将流体从所述存储器注射到所述注射对象中。
示例2:如示例1所述的自动注射器,其中,所述框架是单件式的。
示例3:如示例1所述的自动注射器,其中,所述框架包括:马达安装部,其用于固定地装容与所述柱塞驱动器可操作连通的马达。
示例4:如示例3所述的自动注射器,其中,所述马达、所述驱动器和所述存储器具有位于相同平面上的纵向轴线。
示例5:如示例1所述的自动注射器,其中,所述框架位于所述壳体的近端部分中。
示例6:如示例1所述的自动注射器,其中,所述框架适合于减少所述药筒的平移运动。
示例7:如示例1所述的自动注射器,其中,所述框架适合于减少所述药筒的旋转运动。
示例8:如示例1所述的自动注射器,其中,所述驱动器安装部包括:具有顶部开口的壁式容器。
示例9:如示例8所述的自动注射器,还包括:顶盖,其具有与所述壁式容器中的至少一个间隙互补的至少一个延伸部。
示例10:如示例9所述的自动注射器,其中,所述顶盖包括延伸部,所述延伸部的尺寸设计为适于当所述柱塞驱动器沿远侧方向滑动时,装配到所述壁式容器的近端壁中的间隙与所述柱塞驱动器的近端部分之间。
示例11:一种用于使药筒固定的接纳框架,所述药筒具有连接到自动注射器壳体的连接部,所述药筒在其远端处具有针并且在其近端处机械联接到柱塞驱动器,所述接纳框架包括:腹侧,其用于装配到所述自动注射器的基底部分中;和背侧,其具有:药筒安装部,用于从上方接纳所述药筒,所述药筒安装部包括:具有远端止动部的干涉元件,所述干涉元件的尺寸设计为适于可滑动地联结到所述连接部并允许所述药筒滑动直到所述远端止动部;和卡合元件,其允许所述干涉元件接纳所述连接部,但约束所述药筒使其不脱离连接;和驱动器安装部,其用于固定地装容柱塞驱动器,所述驱动器安装部包括壁式容器,其尺寸设计为适于至少部分地包围所述柱塞驱动器并具有开口顶部以用于从上方接纳所述柱塞驱动器;其中,所述药筒和所述驱动器通过所述柱塞机械联接。
示例12:如示例11所述的接纳框架,还包括马达安装部,其用于固定地装容与所述柱塞驱动器可操作连通的马达,所述马达安装部包括壁式容器,其尺寸设计为适于至少部分地包围所述马达并具有开口顶部以用于从上方接纳所述马达。
示例13:如示例11所述的接纳框架,其中,所述药筒安装部、所述驱动器安装部和所述马达安装部通过单件制成。
示例14:如示例11所述的接纳框架,其中,所述药筒、所述柱塞驱动器和所述马达的纵向轴线位于相同平面上。
示例15:如示例11所述的接纳框架,其中,所述驱动器安装部牵制至少20Kg*cm的力。
示例16:如示例11所述的接纳框架,其中,所述干涉装配部成形为从所述药筒部分的背侧、远侧和腹侧包围所述药筒的一部分。
示例17:一种用于将具有连接部的药筒连接到具有马达的自动注射器的方法,所述药筒在其远端处连接到针并在其近端处机械联接到柱塞驱动器,所述方法包括:将所述药筒在被机械联接到所述柱塞驱动器时降低到所述自动注射器的接纳框架中,所述接纳框架具有开口顶部;使所述药筒沿所述远端的方向滑动,直到到达远端止动部;将所述连接部联结到所述接纳框架的干涉元件;卡合所述连接部,以约束所述药筒使其不脱离连接;和通过所述接纳框架牵制由所述柱塞驱动器产生作用于所述药筒的力,由此使所述药筒相对于所述自动注射器固定。
示例18:如示例17所述的方法,其中,所述牵制力包括:机械干涉所述药筒的轴向平移。
示例19:如示例17所述的方法,其中,所述牵制力包括:机械干涉所述药筒的旋转平移。
示例20:如示例17所述的方法,其中,所述互锁包括从背侧、腹侧、近侧和远侧的至少四个方向包围所述药筒的一部分。
除非另行限定,否则在此使用的所有技术和/或科学用词具有与本发明所属技术领域的普通技术人员通常理解相同的含义。虽然与在此所述相似或等同的方法和材料可用于实践中或本发明的实施例的检测中,不过示例性的方法和/或材料描述如下。在冲突情况下,将以专利申请文件(包括限定)为准。此外,材料、方法和示例仅为例示性的,并非意在必要性限制。
附图说明
本发明的一些实施例在此仅示例性地参照附图描述。现在具体详细地参照附图,应注意,所示细节通过示例示出并用于例示性论述本发明的实施例。对此,通过附图进行的描述对于本领域技术人员如何可实践本发明的实施例是显见的。
在附图中:
图1是方框示意图,示意性表现出根据本发明一些实施例的与药筒装配的自动注射器接纳框架和药筒的驱动系统;
图2是根据本发明一些实施例的用于使药筒相对于自动注射器组件运动固定的方法的高度概览;
图3A是根据本发明一些实施例的示例性单件式接纳框架,例示出用于与自动注射器的部件装配且固定该部件的近端和远端几何形状;
图3B是根据本发明一些实施例的示例性单件式接纳框架,其与自动注射器的各个部件装配;
图4是根据本发明一些实施例的示例性药筒,其具有远端、近端安装销,用于连接到接纳框架;
图5是根据本发明一些实施例的自动注射器的分解图,自动注射器加载有药筒并由盖覆盖;
图6是根据本发明一些实施例的单件式接纳框架的近端部分与药筒的近端部分的示例性几何形状和干涉连接部的放大截面图;
图7是根据本发明一些实施例的药筒和药筒驱动系统的示例性并排构造的立体俯视图;
图8A和8B例示出根据本发明的一些实施例的药筒的卡合装配和固定的侧视图,其中,图8A例示出截面图,图8B例示出局部立体图;
图9是根据本发明的一些实施例的自动注射器的截面侧视图,例示出在固定系统中包括盖延伸部;
图10例示出根据本发明的一些实施例的示例性单件式接纳框架的仰视立体图,其中显示出与药筒的远端装配。
具体实施方式
本发明在其一些实施例中涉及一种自动注射器,且更特别地但非排斥性地涉及自动注射器中的力牵制。
概述
本发明的多个实施例的方案涉及:使药筒相对于自动注射器安装板固定,安装板用于安装在注射对象上。在一些实施例中,固定包括:减小药筒的轴向平移,例如,药筒朝向安装板远端(被限定为包括注射针的端)的轴向平移,和/或药筒朝向安装板近端(被限定为包括柱塞的端)的轴向平移。可替代地或另外地,固定包括:约束药筒的旋转运动,例如采用围绕药筒纵向轴线旋转的形式的运动。
在一些实施例中,希望药筒在注射器中充分固定而使得操作柱塞机构排出内容物不会使药筒运动。如果药筒将要运动,则针可能使患者的在针周围皮肤不适。这特别相关于具有弯曲流体路径的药筒,该弯曲流体路径将药筒的任何旋转运动转变为针的伸长轴线的轴向平移运动。
为了提供这样的固定,在一些实施例中,接纳框架设置在注射器安装板内以接纳药筒。可选地,药筒被固定接纳,即,当药筒被接纳时,其还固定到接纳框架。例如,固定包括:使多于0.1mm和/或多于0.5mm和/或多于1mm和/或多于2mm和/或多于4mm的运动固定。在一些实施例中,接纳框架接合药筒而使得:作用于药筒的力、可能使其平移和/或旋转的力被充分减小。可替代地或另外地,接纳框架被设置为牵制由机械联接到药筒的部件产生的力。在一些实施例中,药筒机械联接到柱塞驱动器,可选地通过与药筒的存储器内停置的柱塞机械联接的驱动系统实现。在一些实施例中,柱塞驱动器设置为可选地通过传动系统与马达机械可操作连通。可选地,由马达和/或由柱塞驱动器产生的力被牵制在接纳框架内。在一些实施例中,单个框架用于固定地接纳药筒及其相关联的柱塞驱动器和/或马达。
可选地,接纳框架被形成为单件式框架。如在此所用,单件式包括:形成和/或模制为单个单元,而没有多于一个部件。应注意,使多个部件互锁以形成单个单元,不包括在此处用词“单件式”的范围内。为了避免药筒的远端部分(针位于此处)运动,优选的是,在力的源的近处(例如包括马达和驱动系统的近端部分)使力消散。可替代地或另外地,有用的是利用具有尽可能少的不同部件的接纳框架,例如不多于三个、或不多于两个、或不多于一个的单件式框架。
在一些实施例中,接纳框架包括:用于固定接纳至少药筒的背侧,和用于安置到安装板上的腹侧。可选地,接纳框架可选地在其一侧处铰接连接到安装板。在一些实施例中,希望注射器壳体将会具有小的高度,可能能够实现更容易的抓握。在一些实施例中,高度可通过以下方式减小:将药筒、驱动器安装板和马达以并排布置方式定位,例如将药筒、柱塞驱动器和马达中的每个的纵向轴线定位在相同平面上,该平面可选地平行于由壳体基底限定的平面和/或用于安装到注射对象上的平面。
在一些实施例中,接纳框架包括至少一个干涉元件,其具有用于固持药筒的几何形状。在一些实施例中,干涉元件接合于药筒中所包括的连接部,例如互补几何形状。例如,干涉元件可包括固持体,药筒主体上的采用延伸部形式的互补几何形状可滑入到固持体中。在一些实施例中,药筒及其互补几何形状朝向壳体远端滑动,直到远端止动部。可选地,互补几何形状于是通过位于后面的闭锁件而锁到最终停置位置,使得药筒可通过向下滑动按击操作被插入。如在此所用,干涉元件包括约束几何形状,用于例如通过从三个方向包封连接部或者通过沿三个方向被连接部包封来接合药筒的连接部。
可替代地或另外地,药筒可包括互补几何形状,采用凸缘和/或切除部和/或斜部和/或凹陷和/或突起和/或销和/或稳定部和/或孔和/或卡合配件和/或钩和/或销的形式,被设计成配合于接纳框架的干涉元件的配件。可选地,干涉元件包括凸缘和/或切除部和/或斜部和/或凹陷和/或突起和/或销和/或稳定部和/或孔和/或卡合配件和/或钩和/或销。
在一些实施例中,设置非对称的药筒。可选地,将非对称的注射筒以正确取向加载到装置中需要基准部位和/或连接部。在一些实施例中,干涉元件的与药筒的互补几何形状配合的几何形状用作基准部位。
在一些实施例中,干涉元件的尺寸和形状设计成适应于互补几何形状的三侧,可选地为背侧、腹侧和远侧,形成沿三个方向固持互补几何形状的固持体。可替代地,互补几何形状可选地在背侧、腹侧和近侧上包围干涉元件。在一些实施例中,在互补元件的背部分和腹部分上的机械干涉机械地阻止它们的运动。在一些实施例中,至少两个干涉元件设置在沿药筒纵向轴线的相对位置,每个位于横跨药筒存储器的相对位置。可能地,在横跨药筒圆形直径定位的至少两个位置提供机械干涉减小旋转运动。
在一些实施例中,在药筒滑动以接合于干涉元件直到远端止动部之后,弹性元件闭合药筒的第四侧。例如,当药筒降低到接纳框架中时,卡合件可被弹性地向下推动,并且一旦药筒朝向远端滑动,弹性元件释放并从第四侧(例如近侧)紧固药筒。可选地,弹性元件是卡合件。在一些实施例中,设置至少两个卡合件,每个卡合件使至少两个干涉元件与互补几何形状接合紧固。在一些实施例中,例如通过远端止动部从远端和例如通过弹性元件从近端紧固药筒的互补几何形状减小沿侧向、轴向的移位的运动。
在一些实施例中,接纳框架被构造成将药筒的近侧与柱塞驱动器固持到一起。在一些实施例中,壁式驱动器安装部平衡柱塞驱动器的向后力,同时干涉元件平衡柱塞驱动器与药筒之间的纵向力。在一些实施例中,传动结构、柱塞驱动器和药筒之间形成的扭矩被引导到接纳框架的近端部分。在一些实施例中,干涉元件和壁式牵制结构防止沿远侧方向运动、沿向上方向运动、或沿围绕药筒轴线旋转运动。在一些实施例中,近端弹性元件防止药筒向近侧运动,还防止药筒从接纳框架脱离连接。
在一些实施例中,接纳框架包括远端互补元件,用于接合和稳定药筒的接近于针的远端部分。在一些实施例中,药筒包括弯曲流体路径,从背出口延伸并朝向药筒腹侧弯曲。在一些实施例中,远端互补元件位于药筒的自由腹侧上。在一些实施例中,当远端互补元件接合于接纳框架时,从针发出的力(例如由于使用针或者由于输送冲击所致)消散。例如,药筒的远端部分可具有伸长的突起,其延伸超出药筒边缘,且为互补的以滑动到接纳框架中设置的孔中。在一些实施例中,远连接器针对针插入的竖直力或针对针的侧向力保持针稳固。在一些实施例中,配合的几何形状还防止沿轴向方向向前运动。在一些实施例中,远端销处于药筒的截面内,不会干涉填充药筒的过程。
在一些实施例中,药筒自身包括互补几何形状元件以与接纳框架中的几何形状元件装配。在一些实施例中,药筒的存储器上的截面没有轴向对称性,例如不是圆形。可替代地或另外地,药筒的存储器上的截面例如通过使在存储器的任一侧上具有几何形状元件而具有中心对称性。在一些实施例中,药筒通过模制而制成,可选地通过Crystal Zenith实现。模制的可能的优点是:可以构建成药筒几何形状特征,其使注射筒更易于安装到注射装置中。可替代地或另外地,注射筒可包括模制部件。可选地,模制部件包括延伸部。例如,模制部件可由Daikyo Resin CZ(Crystal Zenith)或者其它环烯烃聚合物(COP)或者适用于药品产品的任何可模制材料制成。可替代地或另外地,模制部件可例如由聚碳酸酯和/或聚丙烯和/或其它聚合物制成。
本发明的一些实施例的方案涉及一种接纳框架,以装配到自动注射器内,可选地在近端部分内,并用于牵制在马达、柱塞驱动器和药筒(包括柱塞)之间产生的力。在一些实施例中,设置单件式框架,其具有至少两个安装牵制结构,为柱塞驱动器和药筒中的每个设置一个。在一些实施例中,单件式框架为马达进一步设置有第三安装牵制结构。可选地,单件式框架包括壁,用于牵制和消散从马达和/或柱塞驱动器中的每个发出的力。
在一些实施例中,接纳框架被构造成从上方接纳药筒,其机械联接到柱塞驱动器。可选地,药筒通过柱塞机械联接到柱塞驱动器,柱塞停置在药筒存储器内并机械地连接到柱塞驱动器的至少一个臂。在一些实施例中,柱塞驱动器包括驱动组件,可选地为可伸缩系统。例如,柱塞驱动器可包括螺纹伸缩棒,使得当传动结构(例如通过马达)旋转时,伸缩棒使柱塞伸到存储器中,可能使得药物物质排放到药筒流体路径之外。
可替代地,接纳框架被构造以从上方接纳药筒,该药筒例如通过机械联接于马达与柱塞驱动器之间的操作性连通结构的传动结构而机械联接到柱塞驱动器和马达。
在一些实施例中,接纳框架的安装牵制结构包括开口顶部,允许药筒及其相关联部件从上方降低到接纳框架中。在一些实施例中,接纳框架的几何形状被构造成允许药筒与柱塞驱动器沿侧向滑动,例如朝向接纳框架远端滑动。
为了自动操作,在一些实施例中,设置电动马达以操作柱塞。为降低装置轮廓而使其易于针对皮肤保持平坦和静止,马达在一些实施例中沿与药筒的轴线在相同平面上的轴线安置。可选地,马达和药筒/柱塞轴线相互平行。进一步可选地,二者均大致垂直于向皮肤中注射的轴线,例如此时药筒包括弯曲流体路径。
在一些实施例中,药筒安装部设置在接纳框架中以从上方接纳药筒。可选地,药筒在其降低到接纳框架中之后固定到接纳框架。可替代地,药筒当其正降低到接纳框架中时固定到接纳框架。如在此所用,固定到接纳框架涉及:将药筒约束就位,例如,对多于0.1mm、和/或多于0.5mm、和/或多于1mm、和/或多于2mm、和/或多于4mm的运动进行约束。在一些实施例中,药筒安装部包括具有远端止动部的干涉元件,干涉元件的尺寸设计为适于可滑动地接纳药筒,并允许药筒滑动直到远端止动部。
在一些实施例中,驱动器安装部设置在接纳框架中以固定地装容驱动器安装部。在一些实施例中,驱动器安装部包括壁式腔室,至少部分地包围柱塞驱动器。在一些实施例中,腔室壁与柱塞驱动器的紧密接近使柱塞驱动器中产生的力消散,使得可能到达药筒的力减小。
在一些实施例中,驱动器安装部的壁式牵制结构在其近端处包括间隙,该间隙的尺寸设计成适于容纳驱动器柱塞的近端部分。可选地,当药筒以及驱动器柱塞降低到接纳框架中时,所述间隙有助于消除机械干涉。在一些实施例中,一旦药筒及其相关联的驱动器柱塞朝向壳体的远侧移动,则间隙不再容纳驱动器柱塞。可选地,壳体顶盖包括延伸部,延伸部的尺寸和/或形状设计成适于装配在所述间隙与柱塞驱动器的近端部分之间。可选地,盖延伸部用作额外的支撑臂,辅助驱动器安装部的力消散。
在一些实施例中,马达安装部设置在接纳框架中以装容马达并消散由马达产生的力。在一些实施例中,马达安装部包括开口顶部用于从上方接纳马达。可选地,马达安装部包括可选地相对定位的至少两个壁,所述壁的尺寸设计成适于装配到马达侧上,可选地到其纵向侧。在一些实施例中,所述壁包括轨道,用于可滑动地引导和紧固马达的接纳。
可选地,接纳框架设置有传动安装部。在一些实施例中,传动安装部位于马达安装部与柱塞驱动器安装部之间。在一些实施例中,传动安装部包括细长棒,所述细长棒被构造成装配于轮式传动系统的中心。
在一些实施例中,驱动器安装部和/或马达安装部适合牵制至少10Kg*cm或至少15Kg*cm、或至少20Kg*cm、或至少25Kg*cm的力。
本发明的一些实施例的方案涉及:在具有弯曲流体路径的药筒与自动注射器设备之间的力牵制。在一些实施例中,力牵制包括:例如当驱动流体流出药筒时,减少药筒的针相对于注射器基底的运动,这可能源自于作用于药筒上的力。在一些实施例中,注射器基底设置有单件式安装框架,其具有干涉几何形状以与药筒装配,可选地至少与药筒的远端部分和药筒的近端部分装配。
在一些实施例中,单件式框架被构造成牵制沿药筒纵向轴线的力。特别地,在一些实施例中,在柱塞驱动器系统与柱塞之间的强力被消散。典型地,相对较强的力可通过柱塞驱动系统作用于药筒上,例如约3-4Kg。强力可导致药筒不稳定,这可导致药筒运动和/或破裂。
可替代地或另外地,单件式框架被构造成牵制旋转力。在一些实施例中,药筒以一角度连接到针,形成对药筒的侧向和旋转运动均敏感的构造,其中,注射筒的小的运动(旋转和/或平移)可导致用户疼痛或者装置失效。这不同于具有直针的注射筒,其通常对旋转位移不敏感。
在一些实施例中,单件式框架结构被设计成在易受冲击的药筒位置处形成局部力平衡,例如在包括针的药筒远端处,在此处,当针被推入用户身体中时被施加力;和/或在包括柱塞驱动组件的近端处,在此处,力被施加到柱塞上以驱动流体流出药筒。使用单件式框架用于牵制沿轴线的纵向力的可能的优点是:框架具有耐久性以承受由于注射器操作而施加的力,可能会减少破裂和/或可能在多个相互连接部件中出现的解体。通常纵向力在注射筒的不同部件上和/或在不同端处被平衡。例如,近端柱塞驱动力可由近端处的通口吸收,而针对药筒的远端力可由注射器的前部处的注射器壳体吸收。这可导致注射器不稳定和/或导致在各部件之间的接合部上的强力。
本发明的一些实施例的方案涉及低剖面贴片自动注射器。在一些实施例中,低剖面贴片式自动注射器可包括框架,框架被装配以装容药筒。在一些实施例中,框架是壁式的。在一些实施例中,框架在注射器的前部远端(针端)处被枢转地连接到基底。在一些实施例中,注射器包括盖。在一些实施例中,药筒中的注射筒是对称的。在一些实施例中,药筒中的注射筒是非对称的。在一些实施例中,框架包括支撑药筒的接纳框架。
在一些实施例中,壁式框架至少一部分具有底板。在一些实施例中,框架壁的高度在不同位置是不同的。在一些实施例中,壁在其周边上是连续的。在一些实施例中,壁在其周边的一部分上是不连续的。在一些实施例中,盖装配于框架壁上。在一些实施例中,盖壁顺应并平行于框架壁。在一些实施例中,盖壁覆盖框架壁的缺失部分。在一些实施例中,盖包括可移除的中心区部。在一些实施例中,盖中心区部包括平行于盖壁的一部分的壁,从而在此位置形成双壁。
本发明的一些实施例的方案涉及支撑药筒的接纳框架。在一些实施例中,接纳框架包括应力牵制封闭体。在一些实施例中,应力牵制封闭体以机械方式调和由注射筒作用在框架上的应力,反之亦然。在一些实施例中,所述封闭体包括注射器盖的一部分。在一些实施例中,应力牵制封闭体稳固和稳定药筒。在一些实施例中,接纳框架包括用于支撑药筒的结构。在一些实施例中,接纳框架包括联接机构以将药筒附接至其。在一些实施例中,联接机构包括注射器盖。在一些实施例中,药筒包括抓握构件。在一些实施例中,接纳框架-药筒联接机构用作引导部,并引导药筒安装到其在接纳框架上的正确最终位置。在一些实施例中,接纳框架支撑注射器注射筒柱塞驱动动力机构。
在一些实施例中,接纳框架支撑印刷电路板(PCB)。在一些实施例中,接纳框架支撑盖锁定/解锁机构。在一些实施例中,接纳框架为框架提供结构支撑。
药筒可在无菌消毒环境中使用标准设备预填充,以在插入注射器中之前填充注射筒。注射器本身不需要无菌。由于针被模制到药筒中,因而希望药筒充分固定在注射器中,使得柱塞机构操作以排出内容物不会使药筒运动。如果药筒运动,则针可导致患者的在针周围皮肤的不适。为了提供这样的固定,可提供装配到注射器内的夹,所述夹具有闭锁机构以固持药筒。闭锁机构可包括桥式固持器,药筒主体上的延伸部可滑动到所述桥式固持器中并且然后通过位于后面的闭锁件被锁定到最终停置位置,使得药筒可通过向下滑动按击操作被插入。
当注射器位于皮肤上时,注射器可通过无论是患者或是医务人员的用户简单的按压动作实现针插入。针盖被移除,注射器安置在皮肤上,并且钮被按压。
在详细解释本发明的至少一个实施例之前,应理解,本发明不必使其应用局限于在以下描述中提出和/或在图和/或示例中例示的部件的结构和布置和/或方法的细节。本发明能够能够以各种方式实践和执行其它实施例。
药筒固定方框示意图
现在参见附图,图1所示方框示意图展现出根据本发明一些实施例的用于与药筒装配的自动注射器安装框架和药筒的驱动系统。
在一些实施例中,自动贴片式注射器安装到注射对象上。在一些实施例中,自动注射器包括安装板101。在一些实施例中,安装板101用于固持装置,并用于装容注射器的内部部件,例如在其远端104具有针116并在其近端106具有柱塞141的药筒120。在一些实施例中,药筒120包括可选地被填充以药物物质的存储器。如在此所用,药物物质包括:用于注射到注射对象中的任意流体,例如药品、安慰剂、营养物,等等。
在一些实施例中,安装板101包括:接纳框架110,用于固定地装容自动注射器的至少一些内部部件。可选地,接纳框架110是单件式的,即,通过单个材料件制成。在一些实施例中,接纳框架110包括:腹侧,用于与安装板101和/或注射器基底部分固定;背侧,其具有用于装容内部注射器部件的几何形状。
在一些实施例中,力由马达170产生,并可选地通过传动系统被传送到柱塞驱动器140。在一些实施例中,当驱动药筒120内的柱塞141时,由柱塞驱动器140产生大的力(例如3-5kg)。为了消除药筒纵向轴线上的力(可能会屈服和断裂),在一些实施例中,力通过其产生部位的近处的接纳框架110被消散。
在一些实施例中,接纳框架110包括用于固定地牵制力生成部件和/或力影响部件的几何形状。例如,接纳框架110可包括:注射器的驱动系统,其至少包括用于固定地接纳药筒120的药筒安装部、用于装容柱塞驱动器140的驱动器安装部、和用于装容马达170的马达安装部。在一些实施例中,力被局部平衡。在一些实施例中,接纳框架110包括的几何形状装容注射器驱动系统的相互接近的各部件,例如在近端106。牵制接近的力施加和被施加部件的可能的优点可为:力可在其产生和/或发生影响的近处消散,而不会延展到注射器的其它区域。用于牵制力的有限空间的另一可能的优点为:接纳框架110中的力牵制结构被设置在有限区域处,减少结构冗余性。
在一些实施例中,接纳框架110包括平台,例如平整结构。在一些实施例中,驱动系统的各部件、至少为药筒120、柱塞驱动器140、马达170在平台上并排装容,可选地每个部件沿其纵向轴线安置。在一些实施例中,药筒120、柱塞驱动器140、马达170的纵向轴线位于相同平面上,和/或在平行平面上,可选地另外还平行于注射器基底平面。将纵向轴线沿侧向安置在大致相同平面上的可能的优点是:限制壳体和注射器装置的高度,可能使得更易于手持且更易于运输。
药筒固定的高度概述
现在参见图2,其显示出根据本发明一些实施例的用于固定药筒相对于自动注射器壳体运动的方法的高度概览。
在一些实施例中,设置壳体202,壳体内具有接纳框架。在一些实施例中,接纳框架用作底盘,装容注射器内部部件。在一些实施例中,药筒从上方降低204至装配于壳体内的接纳框架中。可选地,药筒在机械联接到柱塞驱动器时降低。在一些实施例中,药筒与柱塞驱动器之间的机械联接包括可选地伸缩式延伸的臂,所述臂机械地连接到停置于药筒存储器内的柱塞。可替代地或另外地,药筒可在机械联接到马达时降低至接纳框架中,马达可选地通过传动系统与柱塞驱动器可操作地机械连通。
在一些实施例中,药筒可选地及其相关联部件通过朝向接纳框架的远端滑动沿侧向运动206,所述远端被限定为与药筒远端部分(其包括针出口)装配的端。在一些实施例中,通过在206中滑动药筒,药筒可选地通过与接纳框架中设置的几何形状接合(例如干涉元件和/或卡合销锁)与接纳框架互锁208。通过位置移位到装配几何形状而启动接合的可能的优点是:其能够实现精巧的互锁机构,即,需要施加少量力的机构,这不同于基于首先推离干涉元件、而非滑入其中而操作的弹性装配机构。
在一些实施例中,药筒在机械联接于注射器驱动系统(例如柱塞驱动器和/或马达)时从上方下降。在一些实施例中,接纳框架包含壁式腔室以接纳药筒的联接部件。在一些实施例中,壁式腔室在壁高度上不一致,例如具有间隙,并能够使驱动系统的一些部分延伸超出壁式腔室的边界。可选地,通过使药筒滑动206至其互锁位置,延伸超出边界的驱动系统部件被移动而作为整体位于壁式腔室的边界内。在一些实施例中,具有间隙的壁与驱动系统部件之间形成空间。
可选地,接纳框架被覆盖210以壳体盖。在一些实施例中,壳体盖与接纳框架的壁式腔室中的间隙区域互补。在一些实施例中,壳体盖包括延伸部,该延伸部在尺寸和/或形状上适于装配于壁与移动部件之间的空间中。在一些实施例中,延伸部的填充物为部件提供机械支撑,有助于使从部件发出的力消散。例如,在机械地连接到柱塞时,柱塞驱动器可设置在相对于药筒的近端位置。装容柱塞驱动器的壁式腔室中的间隙能够使柱塞驱动器的近端部分延伸超出壁边界。当药筒通过滑动向远侧移动时,所联接的柱塞驱动器亦是如此。通过向远侧移动,柱塞驱动器可现在完全被装容在腔室内。
然而,剩余的间隙可能导致力牵制不足,这导致柱塞驱动器朝向近侧方向移动。用盖填充此空间可提供平衡这些力的支撑壁,从而减少柱塞驱动器的运动。在一些实施例中,柱塞驱动器通过使螺纹伸缩式延伸部朝向远侧方向分别延伸来输送212流体,其中柱塞相对于柱塞驱动器设置在远侧方向。柱塞于是被推向包括针的远侧定位的出口,以驱动流体流出药筒。设置壁式腔室形式的近端支撑部提供锚定部位,使延伸臂能够克服流体压力向远侧推动柱塞,而非向近侧推动柱塞驱动器。
示例性的单件式安装框架
现在参见图3A,其例示出根据本发明一些实施例的示例性单件式安装框架,例示出近端和远端几何形状,用于装配于且固定注射器部件。
在一些实施例中,接纳框架110包括两个几何形状装配区域,近端区域和远端区域。在一些实施例中,远端区域通过远端安装部325紧固药筒120的远端部分,例如图4和图10中示例和图示的,图4显示出药筒120的远端安装销422,图10显示出接合于药筒120的远安装销422的远端安装部。在一些实施例中,接纳框架110的近端区域包括注射器的近端力生成部件。在一些实施例中,这两个区域位于接纳框架的底板111上,底板111可选地在各区域之间不连续,如图10中示例和所示。在一些实施例中,底板111大致平坦并用作其上设置接纳框架110的互补几何形状的基底。
在一些实施例中,接纳框架的近端部分包括:药筒安装部327、柱塞驱动器安装部315、马达安装部317。可选地,所有安装部设置为相互接近,消散在力生成部位的近处的力并减少传播到紧固较弱的部件和区域的力。在一些实施例中,每个安装部包含在尺寸和形状上牵制注射器部件的几何形状特征。可选地,接纳框架及其几何形状特征是单件式的,例如通过在模制过程中产生其几何形状特征。在一些实施例中,安装部包括接合壁和/或几何形状以牵制来自安装部的两侧的力。
在一些实施例中,药筒安装部327包括互补几何形状以与药筒120的近端中的几何形状结构装配。例如,干涉元件332、远端止动部333和卡合件334进一步例示和图示在图6、8A、8B、9、10中。
在一些实施例中,驱动器安装部315包括限定装容腔室的壁316,其可选地覆盖柱塞驱动器的三侧的至少一部分。在一些实施例中,柱塞驱动器的第四侧通过机械联接到药筒120而紧固。可能地,所述壁使由柱塞驱动器140所产生的力稳定,并沿至少三个方向防止其运动。可能有利的是,当柱塞驱动器机械联接到药筒时使柱塞驱动器固定,以减少将导致药筒运动的运动。此外,消散在力生成部位近处的力,减少这些力在其它部位的影响。
在一些实施例中,驱动器安装部317是开放顶部,允许柱塞驱动器从上方加载。在一些实施例中,由于其联接到药筒120而且由于药筒120向远侧移动,因而例如通过提供大于柱塞驱动器140的远-近轴线的壁式腔室,驱动器安装部317的几何形状允许柱塞驱动器140的远侧移位。在一些实施例中,形成在近端壁与驱动器140近端之间的空间由壳体盖的延伸部填充,该延伸部可选地在尺寸和/或形状上适于装配于所形成的空间中。在一些实施例中,设置间隙320以允许驱动器140的更近端的定位,而没有近端壁的机械干涉。间隙320进一步显示和图示在图3B和图9中。
在一些实施例中,设置马达安装部317,其可选地接近于相对紧固的药筒近端。在一些实施例中,马达安装部相对于驱动器安装部315沿侧向定位。在一些实施例中,马达安装部包括:壁318,其匹配于马达170的宽度。可选地,壁318包括:引导轨319,引导马达170插入其安装部317中。在一些实施例中,壁318是不连续的,并且提供访问通路以用于传动系统连接马达170与柱塞驱动器140。
与自动注射器各个部件装配的示例性单件式安装框架
现在参见图3B,显示出根据本发明一些实施例的与自动注射器的一些部件装配的示例性单件式安装框架
在一些实施例中,自动注射器装置包括:致动器,例如马达170,可选地为直流(DC)马达。在一些实施例中,自动注射器装置包括传动结构302,其例如机械联接到柱塞驱动器140。在一些实施例中,自动注射器装置包括电源。当电源电连接到马达170时,马达170可选地使附接到驱动柱塞141的传动结构302的齿轮旋转以排放药品。
可选地,药筒120可安装到所述装置中(例如由用户预安装和/或安装)。在一些实施例中,药筒可包括:存储器410,其可选地装容药品和/或在近端位置以柱塞密封体140堵塞和/或具有延伸部305和/或针116,针116可选地由针帽(未示出)保护。可选地,柱塞驱动器140也可为药筒120的一部分。可替代地或另外地,柱塞驱动器140可为注射器装置的一部分。
在一些实施例中,接纳框架110进一步包括电动马达170,用于操作柱塞141清空存储器410至针116中,可选地将流体从存储器410注射到注射对象中。在一些实施例中,马达和存储器具有平行的纵向轴线,可选地典型地垂直于注射部位处的针的轴线。在一些实施例中,马达170通过安装部318被固持到接纳框架110,并操作可选地具有一系列齿轮的传动结构302以推进柱塞141。
示例性药筒
现在参见图4,例示出根据本发明一些实施例的示例性药筒,其具有远、近安装销,用于与接纳框架连接。
在一些实施例中,自动注射器药筒包括互补几何形状用于与接纳框架110中设置的几何形状装配。例如,药筒120的近端包括安装销425,安装销425可与接纳框架110中的腔332接合。在一些实施例中,安装销425延伸超出存储器410的主体的边界。可选地,安装销425通过销连接部427连接,销连接部427可例如为延伸棒,其连接各销之间且可能提供比彼此不相关的销更大的稳定性和强度。在一些实施例中,安装销425以及可选地和连接部427与接纳框架中其互补几何形状一起,确定药筒120插入注射器中的方向性。可能有利的是,当使用偏心流体出口时和/或当使用弯曲流体路径时提供方向性指示物,例如销425,这两种情况均限定相对于注射对象的优选取向。
在一些实施例中,远端互补几何形状设置在药筒120的远端。例如,远安装销422可选地居中地设置为从药筒远端边界突出的延伸部。在一些实施例中,销422在尺寸上适于在接纳框架110的近端上的配合几何形状。
在一些实施例中,两个销425和销422在形状上设计为接合于位于销远侧的腔。这种方向性通过使药筒朝向远腔滑动直到到达机械止动部而使药筒能够加载。例如,直到销425运行到远端止动部333、和/或直到销422完全插入腔325中且药筒远端壁在机械上约束不进一步运动。可选地,安装销425通过卡合件在近端紧固,所述卡合件弹性地偏斜以允许降低药筒,并且当安装销425向远侧滑动时向回卡合就位。
加载到注射器中并与单件式安装框架装配的示例性药筒
现在参见图5,其例示出根据本发明一些实施例的自动注射器的分解图,自动注射器加载有药筒并以盖覆盖。
在一些实施例中,注射器具有基底部分520,基底部分520被安置成接触待接受注射的对象的皮肤。在一些实施例中,接纳框架110将药筒120接纳和固定到安装板101内。安装板101被枢转地安装到基底520上。
在一些实施例中,接纳框架110包括:干涉元件332,其具有远端止动部333和可选的卡合件,例如弹性卡合锁334。药筒被竖直地降低至滑动连接器中,下推卡合件334。药筒然后向前滑动到远端止动部,而当到达远端止动部时,销锁释放以将药筒从后方抵靠远端止动部锁定就位。将药筒插入到接纳框架110中的向下滑动按击运动通过箭头A和B例示,分别例示出向下加载和朝向远端的侧向滑动。
在一些实施例中,当药筒安置就位之后,盖510装配到安装板101上覆盖药筒120的存储器部分,盖510可选地具有延伸部,例如延伸部512,用于填充在柱塞驱动器140与接纳框架110之间形成的空间中。
示例性几何形状和干涉连接部
现在参见图6,其例示出根据本发明一些实施例的单件式接纳框架的近端部分与药筒的近端部分的示例性几何形状和干涉连接部的放大截面图。
所示为示例性近端连接器结构的立体图,显示出干涉元件和用于将药筒安装到接纳框架的卡合件。可选地,卡合件和/或装配件和/或销可以模制到药筒中。例如,装配件可包括塑料卡合件、铆钉、销、切除部、凹陷、隆起、卡合夹、闭锁件、球配件、销锁、钩,等等。
在一些实施例中,设置两个干涉元件,例如干涉元件332。应注意,图6中所示视图显示出仅一个干涉元件332,但是另一干涉元件设置在此图中未示出的相反侧上。这可应用于所有包括两个构件但是仅显示出一个的其它在此提及的部件,除非另行说明。
在一些实施例中,干涉元件332被成形为通过覆盖销425的三侧而具有腔形状。例如,底侧通过接纳框架底板111覆盖,可选地处于错开位置以从其它方向装配,如在一些实施例中所述,安装销425通过连接部427沿药筒近端的整个长度延伸,如图4中所示。顶侧例如被干涉元件332的悬置于安装销425的悬置部分覆盖。安装销425的远侧例如以远端止动部333覆盖,远端止动部333在一些实施例中包括远机械干涉壁,可选地为干涉元件332的一部分。
在一些实施例中,例如,两个卡合件334销锁到销524以将药筒120的近端固持到接纳框架110。可选地,销锁334是柔性的塑料。药筒120降低到接纳框架110上,销425(例如参见图5)将销锁334向下推,例如通过弹性弯曲塑料销锁334。一旦药筒120就位,则销锁334向回卡合以从其近端紧固销425。可替代地或另外地,销锁334可由弹簧钢制成,和/或可为刚性的且由枢轴和/或弹簧等等固持。
图6中例示出示例性的伸缩式柱塞驱动器140。例如,柱塞驱动器可包括螺纹伸缩棒,使得当传动结构(例如通过马达)旋转时,伸缩棒使驱动柱塞密封体141伸展到存储器410中和/或将药物物质排放到流体路径305外。
图6中还例示出驱动器安装部315,其具有装容壁用于装容柱塞驱动器140,并具有间隙320和空间620,空间620在一些实施例中形成在柱塞驱动器140与驱动器安装部315的近端壁之间并可选地被盖延伸部512填充。
示例性平整构造
现在参见图7,例示出根据本发明一些实施例的药筒和药筒驱动系统的示例性并排构造的立体俯视图
在一些实施例中,药筒120、柱塞驱动器140、马达170并排设置在接纳框架110上方,可减小注射器高度,可使得注射器更易于由注射对象和/或看护者固持。在一些实施例中,部件布置为相互接近,可通过接纳框架110的牵制结构消散在力生成部位的近处的牵制力。
示例性药筒近端装配
现在参见图8A和8B,其例示出根据本发明一些实施例的药筒的卡合装配和固定的侧视图,其中,图8A例示出截面图,图8B例示出局部立体图。
图8A例示出安装有药筒120的接纳框架110的侧视截面的宽范围视图。所示为远端安装部325和包括干涉元件332和卡合件334的近端安装组件。在一些实施例中,柱塞驱动器的装容腔室315位于药筒120的近端的近处。
图8B例示出具有柱塞驱动器140的药筒120的近机械,此时,它们通过停置于存储器410中的柱塞141机械联接。图8B中还显示出具有接纳框架110的药筒120的近端装配组件的近端部,其例如包括由干涉元件332、远端止动部333、卡合件334包围的安装销425。在柱塞驱动器近端处提供紧固组件(例如近端装配组件)的可能的优点是:消散在力生成部位近处(其影响最大之处)的力,并可减少力传播到药筒的紧固或坚固性较弱区域中。
盖延伸部的示例性并入
现在参见图9,例示出根据本发明一些实施例的自动注射器的截面侧视图,例示出在固定系统中包括盖延伸部。
在一些实施例中,间隙320用于接纳柱塞驱动器140的近端,然后该近端通过滑动向远侧移动,柱塞驱动器140通过柱塞141机械联接到药筒120。图9中显示出通过盖510的延伸部512填充的间隙。在一些实施例中,延伸部512对于由柱塞驱动器140的近端部分施加的力(这源自于柱塞驱动器140的螺纹伸缩棒系统的伸长)提供机械抵制。在一些实施例中,延伸部512防止柱塞驱动器140沿近侧方向移动,并能够沿远侧方向推动柱塞141。
示例性药筒远端装配
现在参见图10,其例示出根据本发明一些实施例的示例性单件式安装框架的仰视立体图,其中显示出与药筒的远端装配。
在一些实施例中,框架底板111用作接纳框架110的基底结构,并对接纳框架110的互补和/或牵制几何形状给予机械支撑,而且连接各几何形状特征。图10显示出位于底板111上的几何形状特征的仰视图。
图10中例如显示出,远端安装销422与远端安装部325装配。在一些实施例中,远端安装部325包括在尺寸上适于销422插入的腔。可选地,远端安装部325覆盖销422的至少顶部分,可平衡由于针116插入注射对象中而从腹侧方向到达的机械力。在一些实施例中,远端安装部325还通过以下方式紧固药筒120:机械上约束药筒不相对于接纳框架110进一步运动。
图10中还显示出卡合件334的仰视图。在一些实施例中,接纳框架110的底板111至少在驱动系统近端与药筒远端之间是连续的,用作宽的机械平台基底。可替代地且如图10中所例示,底板111不连续且包括孔。可选地,至少近端和/或至少远端包括底板111的连续区域。连续区域分离的可能的优点是,每个区域将会牵制其近处生成的力,并且所述力将更少地传播到其它区域。
药品输送装置的示例性尺度
在一些实施例中,存储器(例如注射筒)的有效载荷可包括例如0.5~2ml之间和/或2~4ml之间和/或4~6ml之间和/或4~10ml之间和/或更多的药品。在一些实施例中,注射器可排放整个有效载荷作为单一剂量。药物输送装置例如可包括贴片式注射器和/或内置动力驱动器以驱动柱塞和/或排放有效载荷。为了此应用起见,内置动力注射器驱动器可被限定为:通过至少临时储存在注射器内的能量提供动力的驱动机构。动力可被储存在动力供应器中,例如作为化学势能(例如产生膨胀气体的化学物和/或电池)和/或机械势能(例如储存在弹性构件和/或弹簧和/或受压气体中)。例如,驱动器可被设计为在某一时段排放有效载荷,所述时段的范围是20~120秒之间和/或120~600秒之间和/或600秒至1小时之间和/或1小时至1天之间和/或更长。
通常,排放可由驱动器驱动。内置动力驱动器可通过各种机构提供动力,所述机构例如包括:如前所述的马达(例如包括DC马达、致动器、无刷马达)、和/或传动结构(例如包括伸缩式组件)、和/或螺纹元件、和/或齿轮、和/或联接器、和/或弹性机构(例如弹簧和/或橡胶带)、和/或膨胀气体、和/或液压致动器。
根据本发明一些实施例的药品输送装置可包括如前所述的存储器部分。例如,存储器可包括药剂容器和/或注射筒。可选地,注射筒可使用标准设备和/或在无菌室中预加载药剂。预加载的注射筒可选地可包括近端开口。柱塞可选地可密封近端开口和/或保护注射筒内容物的无菌性。无菌针(典型地中空)可选地可连接到注射筒筒。例如,针的中空部可与筒内部流体连通。
针可选地可刚性附接到筒远端处的延伸部。针的全部和/或部分的无菌性可例如通过无菌盖保护。当注射筒被供应和/或安装到注射器中时,无菌盖可保持在针上。例如,药剂容器可选地可包括刚性附接到针的圆柱形筒。在一些实施例中,柱塞可沿筒内侧沿轴向滑动以排放药剂有效载荷。例如,药剂可通过中空针排放。针的突出尖端可以相对于筒轴线的角度取向。
基底的长宽比可被限定为基底最长轴线与最短轴线的长度比。可选地,此轴线比的范围可为1~1.5之间和/或1.5~2之间和/或2~3之间和/或大于3。在一些实施例中,注射器高度的范围可在基底短轴线长度的一半至基底短轴线长度之间和/或基底短轴线长度至基底短轴线长度的两倍之间和/或大于基底短轴线长度的两倍。注射器的高度可提供杠杆作用以在使用后使粘接体枢转离开患者皮肤。
在一些实施例中,针插入到患者皮肤的力的范围可例如为0.02~0.2N之间和/或0.2~0.5N之间和/或0.5~5N之间。可选地,注射药品所需的力(例如施加于注射筒柱塞上的力)的范围可例如为5~60N之间。例如,注射药品所需的力可取决于注射速率和/或药品粘度和/或注射筒几何形状和/或针尺度。
在一些实施例中,针保护机构可通过大于例如10~60N的线性力触发。
例如,药品输送装置可包括自动注射器。自动注射器可通过以足够力人工推动而启动以将针插入。所述装置然后可施加注射力以注射药品。一旦全部药品被注射和/或当存在阻碍和/或阻塞时,注射力可升高直到其超过触发针防护和/或结束注射的阈值。
例如,在阻塞情况下和/或在输送结束时,由所述装置产生的线性力可增大到高至60N的水平。针防护机构(例如针缩回机构)可对力敏感。例如,所述机构可包括:卡合件,其在40N失去控制而使针返回到缩回位置。
在一些实施例中,注射药剂和/或触发针防护的应力可以包括扭矩。例如,药剂注射可由柱塞驱动。柱塞可选地可由螺纹组件,例如螺纹螺丝和/或齿和/或伸缩组件驱动。可选地,齿和/或相关联螺丝的螺距的范围可例如为0.5~2mm之间。螺丝的直径的范围可例如为2.5~15mm之间。动力注射的扭矩的范围可例如为0.2~1.0N*cm。触发扭矩(触发针防护的扭矩)的范围可例如为0.5~2N*cm之间和/或2~4N*cm和/或4~10N*cm。
在注射过程中,柱塞的直线运动的范围可例如为10~50mm之间。柱塞的运动长度可例如随待注射药剂的量(其范围可例如为0.5~3ml)而变化。
在一些实施例中,防护机构可对扭矩敏感。例如,针可当所述机构暴露于扭转力矩时缩回。可选地,排放可通过扭矩驱动。例如,驱动器可施加扭矩到螺纹元件以推动柱塞。当驱动器上的扭矩达到阈值时,针可释放和/或缩回和/或可采用针罩。可替代地或另外地,触发机构可同时需要扭矩和线性力。例如,同时需要扭矩和线性应力可防止由于瞬时摩擦所致的过早启动。
在一些实施例中,存储器可具有的长度的范围例如为20~42mm和/或42~48mm和/或48~80mm和/或80~200mm之间。在一些实施例中,存储器的内圆柱形空间可具有范围例如为1~3mm和/或3~10mm和/或10~15mm和/或15~25mm和/或25~50mm之间的平均宽度。可选地,存储器可以具有圆形截面,使得宽度是圆形直径。在一些实施例中,延伸部可具有直线形端部分,其具有的长度的范围例如为1~3mm或3~7mm或7~8mm或8~10mm或10~15mm或15~50mm之间。在一些实施例中,针的露出的直线形部分具有范围可例如为1~5mm或5~7mm或7~10mm或10~20mm之间的长度。
对于非均匀截面而言,平均外宽度可被限定为:可封闭颈部的最小椭圆形的宽度在颈部长度上的平均值。在一些实施例中,延伸部与存储器腔之间的流体路径可包括27号针或者范围在25~30号之间的针或者范围在20~25号之间的针或者范围在30~32号之间的针。在一些实施例中,从延伸部突出的针可包括27号针或者范围在25~30号之间的针或者范围在20~25号之间的针或者范围在30~32号之间的针。
通用内容
如在此所用,用词“约”是指±25%。
用词“包括(comprises)”及其变体(comprising)、“包含(includes)”及其变体(including)、“具有”及它们的同源词意味着:“包括但不限于”。
用词“构成”意味着“包括且限于”。
用词“主要构成”意味着:组分、方法或结构可包括另外的成分、步骤和/或部件,但仅当所述另外的成分、步骤和/或部件不实质改变所请求保护的组分、方法或结构的基本和新颖特性时如此。
如在此所用,单数形式“一”、“一个”、“所述”包括表示多个,除非上下文中另外明确指明。
在本申请全文中,本发明的各个实施例可按照范围形式呈现。应理解,按范围形式的描述仅为了方便和简要,不应被认为是在本发明范围内的严格限制。相应地,范围描述应被认为已具体公开所有可能的子范围以及此范围内的个体数值。例如,如1至6的范围描述应被认为已具体公开各子范围(例如,1至3、1至4、1至5、2至4、2至6、3至6,等等)、以及此范围内的个体数(例如,1、2、3、4、5、6)。这适用于任意范围宽度。
无论何时在此指出数字范围,则其是指:包括所指范围内的任意所述数字(分数或整数)。表述第一指示数字与第二指示数字“之间的范围”和“从”第一指示数字“到”第二指示数字的范围在此能够互换使用,并且是指包括第一指示数字和第二指示数字以及它们之间的所有分数和整数数字。
应认识到,本发明的特定特征(其为了清楚起见在其它实施例的上下文中描述)也可与单个实施例组合提供。相反地,本发明的各个特征(其为了简要起见在单个实施例的上下文中描述)也可单独地或以任意适合子组合方式提供,或者提供为适用于本发明的任意其它所述实施例。各个实施例的上下文中所述的特定特征被认为不是这些实施例的关键特征,除非该实施例在没有这些元件的情况下无法操作。
虽然本发明已经结合其特定实施例描述,但是显然多种可替代方案、修改方案和变化方案对于本领域技术人员而言将是显见的。因此,意在包含所有处于所附权利要求书的精神和广义范围内的这种可替代方案、修改方案和变化方案。
在此说明书中提及的所有公开物、专利和专利申请在此以全文通过引用并入本说明书中,其程度等同于每个独立公开物、专利或专利申请通过引用具体独立描述并入本文。此外,在此申请中任何文献的引用或识别应被理解为并不是承认这些文献可用作本发明的现有技术。对于所用的段落标题,其应被认为不作为必要限定。
Claims (10)
1.一种用于使药筒固定的接纳框架,所述药筒包括连接到自动注射器壳体的连接部,所述药筒在所述药筒的远端处具有针并且所述药筒在所述药筒的近端处机械地联接到柱塞驱动器,所述接纳框架包括:
腹侧,其构造为装配到所述自动注射器壳体的基底部分中;和
背侧,其包括:
药筒安装部,用于从上方接纳所述药筒,所述药筒安装部包括:具有远端止动部的干涉元件,所述干涉元件的尺寸设计为适于可滑动地联结到所述连接部并允许所述药筒滑动直到所述远端止动部;和卡合元件,其允许所述干涉元件接纳所述连接部,但约束所述药筒使其不脱离连接;和
驱动器安装部,其用于固定地装容柱塞驱动器,所述驱动器安装部包括壁式容器,其尺寸设计为适于至少部分地包围所述柱塞驱动器并限定开口顶部以用于从上方接纳所述柱塞驱动器;
其中,所述药筒和所述驱动器安装部通过所述柱塞驱动器机械地联接。
2.如权利要求1所述的接纳框架,还包括马达安装部以用于固定地装容与所述柱塞驱动器可操作连通的马达,所述马达安装部包括壁式容器,其尺寸设计为适于至少部分地包围所述马达并限定开口顶部以用于从上方接纳所述马达。
3.如权利要求2所述的接纳框架,其中,所述药筒安装部、所述驱动器安装部和所述马达安装部通过单件制成。
4.如权利要求2所述的接纳框架,其中,所述药筒、所述柱塞驱动器和所述马达的纵向轴线位于相同平面上。
5.如权利要求1所述的接纳框架,其中,所述驱动器安装部牵制至少20Kg*cm的力。
6.如权利要求1所述的接纳框架,其中,所述干涉元件成形为从所述药筒部分的背侧、远侧和腹侧包围所述药筒的一部分。
7.一种用于将包括连接部的药筒连接到包括马达的自动注射器的方法,所述药筒在所述药筒的远端处连接到针并在所述药筒的近端处机械地联接到柱塞驱动器,所述方法包括:
将所述药筒在所述药筒被机械联接到所述柱塞驱动器时降低到所述自动注射器的接纳框架中,所述接纳框架限定开口顶部;
使所述药筒沿所述远端的方向滑动,直到到达所述接纳框架的远端止动部;
将所述连接部联结到所述接纳框架的干涉元件;
卡合所述连接部,以约束所述药筒使其不脱离连接;和
通过所述接纳框架牵制由所述柱塞驱动器产生作用于所述药筒的力,由此使所述药筒相对于所述自动注射器固定。
8.如权利要求7所述的方法,其中,牵制所述力包括机械干涉所述药筒的轴向平移。
9.如权利要求7所述的方法,其中,牵制所述力包括机械干涉所述药筒的旋转平移。
10.如权利要求7所述的方法,其中,将所述连接部联结到所述干涉元件包括从至少四个方向包围所述药筒的一部分,至少四个方向是背侧、腹侧、近侧和远侧。
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PCT/US2016/068371 WO2017127216A1 (en) | 2016-01-21 | 2016-12-22 | Force containment in an automatic injector |
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2016
- 2016-12-22 JP JP2018538164A patent/JP6513297B2/ja active Active
- 2016-12-22 CN CN202010230499.0A patent/CN111544704B/zh active Active
- 2016-12-22 US US16/071,574 patent/US10610638B2/en active Active
- 2016-12-22 CN CN201680083812.4A patent/CN109219456B/zh active Active
- 2016-12-22 WO PCT/US2016/068371 patent/WO2017127216A1/en active Application Filing
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CN109219456B (zh) | 2020-05-15 |
US10610638B2 (en) | 2020-04-07 |
EP3405227B1 (en) | 2020-06-17 |
CN111544704A (zh) | 2020-08-18 |
US20190030241A1 (en) | 2019-01-31 |
EP3711793A1 (en) | 2020-09-23 |
JP2019502489A (ja) | 2019-01-31 |
JP6513297B2 (ja) | 2019-05-22 |
EP3405227A1 (en) | 2018-11-28 |
EP3711793B1 (en) | 2021-12-01 |
US20200009316A1 (en) | 2020-01-09 |
WO2017127216A1 (en) | 2017-07-27 |
CN109219456A (zh) | 2019-01-15 |
US11364337B2 (en) | 2022-06-21 |
US20220273866A1 (en) | 2022-09-01 |
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