CN102883759B - 药物泵注射针组件 - Google Patents

药物泵注射针组件 Download PDF

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CN102883759B
CN102883759B CN201180006567.4A CN201180006567A CN102883759B CN 102883759 B CN102883759 B CN 102883759B CN 201180006567 A CN201180006567 A CN 201180006567A CN 102883759 B CN102883759 B CN 102883759B
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奥兹·卡比里
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Medimop Medical Projects Ltd
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    • A61M5/14—Infusion devices, e.g. infusing by gravity; Blood infusion; Accessories therefor
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Abstract

一种注射针组件，适于与容纳有待输送给对象的物质的药筒流体连通，该注射针组件的特征在于，偏压装置（70），布置为在注射针（28、116）上施加偏压力以使注射针（28、116）从壳体（30、112）向外伸出以刺穿对象；以及偏压装置释放器（60），包括在初始阻挡偏压装置（70）移动的偏压装置制动器（62），当安全闩锁（32、122）移动至允许移动针保持器（26、118）以使注射针（26、118）从壳体（30、112）向外伸出的位置处时，偏压装置释放器释放偏压装置（70）。

Description

药物泵注射针组件
技术领域
本发明总体上涉及一种外用药物泵，具体涉及一种特别适用于年老、有病或残疾人士的用于药物泵的注射针组件。
背景技术
外用药物泵通常用于向患者输送包含口服不能消化的大分子的物质，比如胰岛素。通常，泵附着至患者腹部并通过插入患者皮肤的插管或注射针向患者输送物质。
同一发明人于2008年12月30日提交的美国专利申请12/345818和2009年12月27日提交的PCT专利申请PCT/US09/69552描述了一种从药瓶施用药物的注射针组件。（在整个说明书和权利要求中，术语“药物”和“物质”可交换使用，并且包含向对象施用的任何物质。在整个说明书和权利要求书中，术语“药筒”包含用于药物的任何容器，诸如但不限于，药筒、药瓶、注射器、瓶、安瓿和众多类似容器，并且其尺寸和形状不限。注射针组件包括保持在针保持器内的注射针、以及用于启动物质穿过注射针的输送的启动机构，诸如使物质输送开始的按钮。启动机构包括防止注射针意外刺痛患者并且防止意外施用药物的安全闩锁（latch）。安全闩锁在初始阻碍针保持器的移动，当安全闩锁置于对象上时，安全闩锁移至允许移动针保持器的位置，以使针从壳体向外伸出以刺穿对象，从而允许向对象施用物质。
现有技术的注射针组件的问题在于，对于年老、有病或残疾人士来说按下按钮来启动物质的输送可能存在困难。
发明内容
本发明致力于提供一种特别适用于年老、有病或残疾人士的用于药物泵的注射针组件，从而解决现有技术中存在的问题，下文将对此进行更详细的说明。
因此，根据本发明一个实施方式，提供了一种适用于与容纳有待输送给对象的物质的药筒流体连通的注射针组件，该注射针组件包括：保持在针保持器内的注射针，针保持器限于在壳体内移动；以及用于启动物质通过注射针的输送的启动机构，该启动机构包括在初始阻碍针保持器移动的安全闩锁，其中，当安全闩锁置于对象上时，安全闩锁移至允许移动针保持器的位置，以使注射针从壳体向外伸出以刺穿对象，从而允许向对象施用物质。
根据本发明的一个实施方式，安全闩锁绕枢轴枢转地安装在底座上。安全闩锁可以布置为选择性地旋转进入或退出形成于底座内的形状互补的槽。
根据本发明一个实施方式，安全闩锁包括位于其远端的第一制动器以及靠近第一制动器并与第一制动器间隔开的第二制动器，所述第一和第二制动器布置为选择性地阻止针保持器的运动。
根据本发明一个实施方式，安全闩锁通过处于第一制动器抵靠从针保持器底部突出的耳把的位置中来在初始阻碍针保持器的移动，从而阻止针保持器移动。
根据本发明的一个实施方式，当安全闩锁置于对象上时，安全闩锁移动至一个位置以便第一制动器从针保持器的耳把移开，从而允许针保持器移动。
根据本发明一个实施方式，控制按钮设置为具有轴。倾斜舌片在轴的下端处从轴的外围突出。当安全闩锁被放置在对象上且控制按钮移动时，倾斜舌片对形成于针保持器上的斜坡施力，从而使针保持器移动并随着针从壳体向外移动而旋转。针保持器能够充分旋转以便耳把可以被第二制动器阻止。将安全闩锁从对象移开使得第二制动器从耳把移开并且使得针保持器继续旋转，这是由于倾斜舌片仍然对斜坡施力。针保持器旋转直到倾斜舌片从斜坡移开，于是针保持器移动以使耳把钩挂至形成于壳体上的台肩，从而将注射针收存（trap）在壳体内。
根据本发明一个实施方式，当控制按钮移动以使倾斜舌片向斜坡施力时，控制按钮被锁定在壳体内。
附图说明
从下文结合附图的详细说明中将会更充分地理解本发明，附图中：
图1是现有技术（美国专利申请12/345818或PCT专利申请PCT/US09/69552）中用于给对象施用物质的器械的简化图；
图2是现有技术器械中安全闩锁处于向下位置的简化图，该向下位置是器械还未被放置在用户身体上并且针保持器不能被推下时的标定（起始）位置；
图3是现有技术安全闩锁处于向上位置的简化图，该向上位置是器械已经被放置在用户皮肤上时的位置；
图4是药物施用完成后将现有技术器械从患者身体提起的简化图，这使得安全闩锁移回到向下位置；
图5是现有技术针保持器向上移回并停止在向上位置中的简化图，其中注射针缩回到器械的壳体内；
图6是根据本发明一个实施方式构造和操作的、用于将物质施用给对象的偏压装置释放器的简化图；
图7是图6的偏压装置释放器的安全闩锁处于向上位置中的简化图，该向上位置是所述器械已经被放置在用户皮肤上时的位置；
图8是根据本发明一个实施方式的、将偏压装置制动器移出壳体以便不阻碍偏压装置的致动器的简化图，所述偏压装置能促使所述器械的注射针刺穿患者皮肤；
图9是根据本发明一个实施方式的、促使注射针到达刺穿位置的偏压装置的简化图；以及
图10是药物施用完成后从患者身体提起离开的偏压装置释放器的简化图，这使得安全闩锁移回到向下位置并且注射针缩回到壳体内。
图11A和图11B是根据本发明一个实施方式构造和操作的、在用于向对象至施用物质的另一器械（药物泵）中采用的偏压装置释放器的简化透视图。
图12是处于图11A–图11B中的位置时所述器械内部的简化图；
图13A和图13B是根据本发明一个实施方式的、处于第二阶段中、在将所述器械应用到患者身体后，图11A–图11B的器械的简化透视图；
图14是处于图13A–图13B的位置中时所述器械内部的简化图；
图15是根据本发明一个实施方式的、处于第三阶段中（其中注射针从泵伸出并插入体内）的图11A–图11B的器械的简化透视图；
图16是处于图15的位置中时所述器械的内部的简化图；
图17A和图17B是根据本发明一个实施方式的、处于第四最后阶段中、将器械从患者身体移除后（其中保护器在注射针使用后阻挡注射针），图11A–图11B的器械的简化透视图；以及
图18是处于图17A–图17B的位置中时所述器械内部的简化图。
具体实施方式
现在参考图1，图中示出了现有技术（美国专利申请12/345818或PCT专利申请PCT/US09/69552）中的用于将物质（例如，胰岛素）施用给对象的器械10。
药筒12（也称作药瓶，术语可互相交换使用）安装在壳体底座14上。在某些申请中，药筒穿刺机构18可移动地（例如，可旋转地）耦接至壳体底座14并刺穿药筒12的远端。待施用物质通过管（未示出）从药筒12流至启动机构20。启动机构20具有控制按钮22并且通常耦接至壳体底座14。启动机构20配置为将插管和/或注射针穿过对象皮肤插入并通过该插管和/或注射针输送物质。本发明的实施方式仅参考注射针进行说明，但是也适用于设置在插管或任何其他输送装置内的注射针。在整个说明书和权利要求中使用的术语“注射针”包括所有这些输送装置。
器械10通常包括电机、电池和控制单元（都未示出）。在注射针已经刺穿患者皮肤后，控制单元控制电机的操作以将可控量的物质以受控的输送速率施用给患者。当然，本发明注射针组件可用于其他应用并且不一定与受控机动输送系统一起使用。
现在参考图2和图3，图中示出了现有技术的安全闩锁。控制按钮22具有布置为对着保持注射针28的针保持器26（见图3）运动（就附图而言为竖直向下运动）的轴24。轴24和针保持器26都限于为在（例如，管状）壳体30内移动，但是轴与针保持器的移动存在差异。轴24限于在壳体30内向下平移而不会旋转。相对地，针保持器26不仅能平移还能在壳体30内旋转（下文将会更详细地进行说明）。
针保持器26的移动选择性地被安全闩锁32阻碍，所述安全闩锁绕枢轴34枢转地安装在壳体底座14上。安全闩锁32布置为选择性地枢转进入或退出形成于壳体底座14内的形状互补的槽37（见图1）。安全闩锁32包括位于安全闩锁远端的第一制动器36以及靠近第一制动器36并与该第一制动器间隔开的第二制动器38。制动器的形状可以构造为突耳（lug）或其他突出部或适用于阻止针保持器26的运动的任何其他结构（下文将进行说明）。
图2示出了处于向下位置中的安全闩锁32，该向下位置为器械10还未置于用户身体上时所述安全闩锁的标定（起始）位置。在该位置处，第一制动器36抵靠从针保持器26的底部突出的耳把40。应注意，对着第一制动器36的表面42推动耳把40不会使针保持器26向下运动，因为这仅会使第一制动器36围绕枢轴34枢转，从而使第一制动器36的另一表面44抵靠壳体30底表面。因此，当安全闩锁32处于向下位置中时，不能向下推动针保持器（当然是就附图而言）。
图3示出了安全闩锁32处于向上位置中时（即，安全闩锁绕枢轴34向上旋转）的视图，该向上位置是器械10已经被置于患者皮肤上时的位置。第一制动器36已经被移出针保持器26的耳把40的路径，以便此刻可以按下控制按钮22以向下移动针保持器26，从而刺穿患者皮肤。在药物施用期间，注射针28仍保持插在患者体内。向下按控制按钮22使得轴24锁定在壳体30内的向下位置中，比如通过将从轴24向外径向突出的一个或多个花键（此处未示出）滑过安装在壳体30内的一个或多个斜切弹性舌片（此处未示出）来实现。在花键滑过舌片后，花键锁定在位，这通过舌片弹性地回弹至适当位置而卡扣在花键上的操作来实现。
在药物施用完成后，器械10被提起而离开患者身体。这使得安全闩锁32移回到如图4中所示的向下位置，从而将第二制动器38从耳把40移开。偏压装置47（比如偏压在第一制动器36与壳体底座14之间的板簧）可以用于在安全闩锁32上施加回复力，以使安全闩锁移回到向下位置。倾斜舌片50在斜坡52上施加向下的力，从而允许针保持器26逆时针旋转直至倾斜舌片50滑离斜坡52。此时，针保持器26向上跳回，并且耳把40钩挂在形成于壳体30上的轴肩54上，如图5所示。在该位置处，由于耳把40止动于台肩54，因此针保持器26不能向下移回。因此，注射针28被收存在器械10内的安全位置中，并且器械10可以安全丢弃。
现在参考图6，图中示出了根据本发明一个实施方式构造和操作的、用于给对象施用物质的偏压装置释放器60。与上面针对现有技术描述的元件相同或等同的本发明的元件以相同的参考标号表示。
如先前所述，在现有技术的器械中，在药物施用后，针保持器26通过逆时针旋转动作缩回到壳体30内，并且耳把40钩挂在形成于壳体30上的台肩54上。在本发明中，可以使用相同的布置方式。替换地或附加地，比如螺旋弹簧的偏压装置59可用于在施用药物后将针保持器26缩回到壳体30内。偏压装置59布置为在箭头57的方向（就附图而言的为向上方向）上在注射针28上施加驱动力。
利用偏压装置释放器60，用户不一定需要施力才能机械地操作所述装置。事实上，可以没有用以按下的控制按钮，或者替换地，控制按钮可以为触敏的或用轻微压力即可操作，诸如螺旋弹簧的偏压装置70被释放以按下注射针（如下文所述）。偏压装置70比偏压装置59更强劲。偏压装置70布置为在箭头71的方向（附图中的向下方向）上在注射针28上施加驱动力。
器械60包括偏压装置制动器62，诸如安装在轴63上的舌片或卡爪（dog），并通过孔口64进入壳体30。制动器66设置为移动偏压装置制动器62。例如，致动器66可以为（不限于）步进电机、线性致动器、螺线管等。在非限制性的说明性实施方式中，致动器66是使与安装在轴63上的正齿轮72啮合的驱动齿轮68旋转的步进电机。偏压装置制动器62可以以螺纹安装在轴63的螺纹部74上。
安全闩锁位置传感器76设置为感应安全闩锁32何时移动至图7的向上位置。安全闩锁位置传感器76可以为（不限于）簧片开关、适用于感应安全闩锁32到向上位置的移动的其他种类的开关或传感器。安全闩锁位置传感器76与控制致动器66操作的控制器78通信。如上所述，现有技术器械10通常包括电机、电池和控制单元。致动器66可以是该相同的电机，控制器78可以是该相同的控制单元，或者致动器和控制器可以是独立的单元。
图6示出了处于向下位置中的安全闩锁32，该向下位置是药物施用器械还未置于用户身体上时的标定（起始）位置（对应于现有技术的图2）。如上所述，在该位置处，针保持器26不能向下推动（就附图而言）。在本发明中的该位置中，偏压装置制动器62位于壳体30内部并且阻挡偏压装置70，从而防止所述偏压装置向下推动到注射针28上。
图7示出了处于向上位置（对应于现有技术的图3）中的安全闩锁32，该向上位置为当药物施用器械已经置于用户皮肤上时的位置。安全闩锁位置传感器76感应安全闩锁32到向上位置的移动并给控制器78发信号告知安全闩锁32现在正处于向上位置中。控制器78随即开始操作致动器66。在一个优选实施方式中，控制器78在预定时延（例如，5–15秒）后开始致动器66的操作，以确保药物施用器械确实专门放置于患者上以便施用药物。
在操作时，致动器66将偏压装置制动器62移出孔口64（如图8所示）。在非限制的说明性实施方式中，致动器66旋转驱动齿轮68，所述驱动齿轮接着旋转正齿轮72以旋转轴63。轴63的旋转使得偏压装置制动器62沿着螺纹部74线性地移出孔口64。当偏压装置制动器62到达螺纹部74的端部时，所述偏压装置制动器在轴63上自由旋转并不再移动。
一旦偏压装置制动器62移出孔64，偏压装置70就不再被阻挡并且该偏压装置立即向下推动到注射针28上（克服了较弱的偏压装置59），如图9所示。注射针28立即刺穿患者皮肤并施用药物。如上文针对现有技术的器械描述的，轴24锁定在壳体30内的向下位置中。
在完成药物施用后，所述器械被提升离开患者身体。如针对现有技术器械所述的，这使得安全闩锁32移回向下位置（如图10所示），注射针28收存回到所述器械内部的安全位置中，并且所述器械得以安全丢弃。
参考图11A–图11B和图12，图中示出了根据本发明一个实施方式构造和操作的、在用于给对象施用药物的另一器械110（也称为药物泵110）中使用的偏压装置释放器60。偏压装置释放器60的元件以与上文相同的参考标号指示。
启动机构20也用于该实施方式中。然而，与前述实施方式相反的是，在器械110中，在药物施用完成后注射针不缩回到壳体内，而是存在一个保护器来阻挡使用后的注射针以防止意外针刺发生（下文将会详细说明）。
在器械110中，如图11A–图11B所示，药筒（未示出）安装在壳体底座112上（或只是安装在壳体112上）。空心注射针（未示出）设置在壳体112内以刺穿药筒远端处的隔膜。待施用的物质从药筒最终流动到保持在针保持器118（限于在壳体117内移动）内的注射针116，这通过偏压装置释放器60控制。如上所述，有了偏压装置释放器60，则没有用以推下的控制按钮。反而是偏压装置70被释放，以便以与上文所述相同的方式向下推动注射针116。
针保持器118的移动选择性地受到安全闩锁122阻碍，所述安全闩锁绕枢轴124枢转地安装在壳体底座112上。安全闩锁122布置为选择性地枢转进入或退出形成于壳体底座112内的形状互补的槽126。安全闩锁122可以由诸如螺旋弹簧的偏压装置28偏压。安全闩锁122形成有针孔129以便允许注射针116从中穿过。
在图11A、图11B和图12所示的第一阶段中，在操作前，安全闩锁122阻挡注射针116的路径以防止意外过早启动（例如，美国专利申请12/345818或PCT专利申请PCT/IJS09/69552中描述的阻挡机构）。
可以设置微传感器120（诸如光敏微型传感器）以便感应注射针的位置并与控制单元联合使用以控制泵操作的各个阶段。除了光敏微型传感器120之外，可以设置另一传感器130（见图12）以便感应安全闩锁122的位置和操作。例如，传感器130可以是磁体传感器130，该磁体传感器感应安装在安全闩锁122的远端上的磁体132是否在传感器130附近。
在图13A、图13B和图14所示的第二阶段中，器械10置于患者身体上（未示出），并且安全闩锁122已经枢转为与壳体底座112齐平。注射针116现在对准以前进穿过安全闩锁122的针孔129。磁体传感器130（或任何其他适合的感应机构）感应到磁体132在安全闩锁122上，则可以表明泵110置于身体上。（应注意的是，为了简单起见，偏压装置释放器60未在图14中示出。）
如上所述，偏压装置释放器60的偏压装置70随后释放以与上文相同的方式将注射针116推入患者体内。注射针116前进穿过安全闩锁122的针孔129而到达图15和图16中所示的位置（操作的第三阶段）。感应机构可以提供表明注射针116被插入的指示。注射针116保持锁定在插入位置中。
参考图17A、图17B和图18。在操作的第四阶段也即最后一个阶段，在施用物质后，将泵110从患者身体移除，从而释放安全闩锁122以枢转至向下位置。然而，由于注射针116已经从壳体伸出并保持锁定在伸出位置中，因此注射针116未与安全闩锁122的针孔129对准（在图18中可以最好地观察到）。因此，安全闩锁122用作保护器以在泵110使用后阻挡注射针116的尖端，从而防止意外的针刺。
本领域技术人员应理解的是，本发明不限于上文具体示出和说明的内容。相反地，本发明范围包括上文所述特征的组合和子组合以及本发明修改和变型，这些是本领域技术人员在阅读前述说明后即可想到的且不在现有技术中。

Claims (13)

1.一种注射针组件，所述注射针组件适于与容纳有待输送给对象的物质的药筒流体连通，所述注射针组件包括：
注射针(28、116)，所述注射针保持在针保持器(26、118)内，所述针保持器(26、118)限于在壳体(30、112)内移动；以及
启动机构(20)，所述启动机构用于启动所述物质通过所述注射针(28)的输送，所述启动机构(20)包括在初始阻碍所述针保持器(26、118)的移动的安全闩锁(32、122)，其中，当所述安全闩锁(32、122)置于所述对象上时，所述安全闩锁(32、122)移动至允许移动所述针保持器(26、118)以使所述注射针(28、116)从所述壳体(30、112)向外伸出的位置，以刺穿所述对象，从而允许对所述对象施用所述物质；
其特征在于，偏压装置(70)，布置为在所述注射针(28、116)上施加偏压力，以使所述注射针(28、116)从所述壳体(30、112)向外伸出以刺穿所述对象；以及偏压装置释放器(60)，包括偏压装置制动器(62)，所述偏压装置制动器在初始阻挡所述偏压装置(70)的运动并且当所述安全闩锁(32、122)移动至允许移动所述针保持器(26、118)以使所述注射针(28、116)从所述壳体(30、112)向外伸出的位置时所述偏压装置释放器释放所述偏压装置(70)。
2.根据权利要求1所述的注射针组件，还包括联接至所述偏压装置制动器(62)以便移动所述偏压装置制动器(62)的致动器(66)。
3.根据权利要求2所述的注射针组件，其中，所述偏压装置制动器(62)安装在轴(63)上，并且所述致动器(66)包括与安装在所述轴(63)上的正齿轮(72)啮合的驱动齿轮(68)。
4.根据权利要求3所述的注射针组件，其中，所述偏压装置制动器(62)以螺纹安装在所述轴(63)的螺纹部(74)上。
5.根据权利要求1所述的注射针组件，还包括安全闩锁位置传感器(76)，所述安全闩锁位置传感器用于感应所述安全闩锁(32、122)何时移动至允许移动所述针保持器(26、118)以使所述注射针(28、116)从所述壳体(30、117)伸出的位置。
6.根据权利要求5所述的注射针组件，还包括联接至所述偏压装置制动器(62)以便移动所述偏压装置制动器(62)的致动器(66)，并且其中，所述安全闩锁位置传感器(76)与控制所述致动器(66)的操作的控制器(78)通信。
7.根据权利要求6所述的注射针组件，其中，所述控制器(78)在预定延时之后开始所述致动器(66)的操作。
8.根据权利要求1所述的注射针组件，其中，所述偏压装置制动器(62)安装在轴(63)上并通过孔口(64)进入所述壳体(30)。
9.一种用于将流体施用给对象的泵(110)，包括：
壳体(112)；
针保持器(118)，包括具有远端的注射针(116)，所述针保持器(118)能在所述壳体(118)内自第一位置和第二位置移动，在所述针保持器的第一位置中所述注射针(116)整体位于所述壳体(112)内，在所述针保持器的第二位置中所述注射针(116)的至少远端延伸到所述壳体(112)外部，以便接合所述对象的皮肤并将所述流体施用给所述对象；
启动机构(20)，所述启动机构用于启动所述流体通过所述注射针(116)的输送，所述启动机构(20)包括安全闩锁(122)，包括延伸穿过所述安全闩锁的针孔(129)，所述安全闩锁(122)能自第一位置和第二位置移动，在所述安全闩锁的第一位置中所述安全闩锁(122)与所述壳体(112)的表面齐平同时所述针孔(129)与所述注射针(116)的远端对准，以使得当所述针保持器(118)移动至所述针保持器的第二位置时所述注射针(116)延伸穿过所述针孔(129)、从所述壳体(112)延伸出进而与所述对象的皮肤接合，在所述安全闩锁的第二位置中所述安全闩锁(122)的至少部分与所述壳体表面分离，所述针孔(129)与所述针(116)的远端错开，且所述安全闩锁(122)的部分接合所述注射针(116)的远端并阻挡接触所述注射针的远端，
其特征在于，偏压装置(70)，布置为在所述注射针(116)上施加偏压力，以使所述注射针(116)从所述壳体(112)向外伸出以刺穿所述对象；以及偏压装置释放器(60)，包括偏压装置制动器(62)，所述偏压装置制动器在初始阻挡所述偏压装置(70)的运动，并且当所述安全闩锁(122)移动至允许移动所述针保持器(118)以使所述注射针(116)从所述壳体(112)向外伸出的位置时，所述偏压装置释放器释放所述偏压装置(70)。
10.根据权利要求9所述的泵(110)，其中，所述安全闩锁(122)绕枢轴(124)枢转地安装在所述壳体(112)上，且在所述安全闩锁的第二位置中所述安全闩锁(122)的所述部分枢转远离所述壳体(112)。
11.根据权利要求9所述的泵(110)，还包括感应所述针保持器(118)的位置的传感器(120)。
12.根据权利要求9所述的泵(110)，还包括感应所述安全闩锁(122)的位置的传感器(130)。
13.根据权利要求9所述的泵(110)，其中，所述安全闩锁(122)被偏压装置(128)偏压。
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EP2525845B1 (en) 2014-08-27
CN105251077A (zh) 2016-01-20
US9149575B2 (en) 2015-10-06
EP2525845A1 (en) 2012-11-28
US8915882B2 (en) 2014-12-23
US9492610B2 (en) 2016-11-15
US20130296785A1 (en) 2013-11-07
BR112012017833A2 (pt) 2016-04-19
US20110178472A1 (en) 2011-07-21
EP2732836A1 (en) 2014-05-21
JP5841544B2 (ja) 2016-01-13
BR112012017833B1 (pt) 2020-09-15
EP2732836B1 (en) 2015-05-20
US20160051756A1 (en) 2016-02-25
US20150088071A1 (en) 2015-03-26
US20140228780A1 (en) 2014-08-14
US9764092B2 (en) 2017-09-19
US20160228644A1 (en) 2016-08-11
WO2011090955A1 (en) 2011-07-28
CN105251077B (zh) 2017-10-27
US9522234B2 (en) 2016-12-20
US8348898B2 (en) 2013-01-08
JP2013517094A (ja) 2013-05-16

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