CN101484198A - 尾部装有固定针的注射器和具有该注射器的自动注射装置 - Google Patents

尾部装有固定针的注射器和具有该注射器的自动注射装置 Download PDF

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CN101484198A
CN101484198A CNA2005800467361A CN200580046736A CN101484198A CN 101484198 A CN101484198 A CN 101484198A CN A2005800467361 A CNA2005800467361 A CN A2005800467361A CN 200580046736 A CN200580046736 A CN 200580046736A CN 101484198 A CN101484198 A CN 101484198A
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piston
syringe
plunger
fixed needle
needle syringe
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理查德·大卫三世·吉莱斯皮
道格·欧文·克罗
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West Pharmaceutical Services Inc
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Abstract

一种具有药物室的固定针注射器，该固定针注射器设有皮下注射针、活塞和柱塞。皮下注射针与药物室流动连通。活塞可滑动地设置在药物室中。柱塞与活塞固定。柱塞具有经由其中限定的孔，该孔允许通过柱塞通向活塞。

Description

尾部装有固定针的注射器和具有该注射器的自动注射装置
对相关申请的交叉引用
本申请要求2004年12月9日提交的美国临时申请60/634,486的优先权，并涉及2003年6月20日提交的、共同拥有和转让的美国申请10/601,212，这两个申请的内容都通过引用并入本申请。
技术领域
本申请公开的内容涉及固定针注射器。更具体而言，本申请公开的内容涉及尾部装有固定针的注射器和具有该注射器的自动注射装置。
背景技术
固定针注射器通常包括固定至药物室并与其流动连通的针。通常作用于在药物室中的弹性活塞的柱塞，被用于从诸如药瓶或安瓿瓶的另一容器中通过吸入或抽吸(下文称为“抽吸”)药品溶液而填充药物室，从药物室中排出空气，及在注射部位将药物从药物室中释入组织。
在抽吸过程中，注射器的针通过药瓶的隔膜插入。然后，拉动活塞以将药物从药瓶中吸入注射器的药物室中。因此，此种固定针注射器的针设计成可以承受在通过隔膜插入过程中所施予的压力，并且在抽吸过程中允许足够的流体流动。
药物注射产生的疼痛和/或不舒适的程度，至少部分地，取决于针的尺寸或规格(“规格”)。遗憾的是，针规格越大，对注射部位组织的损伤越大，从而造成接受注射的人的疼痛感越强。
在使用时填充的注射器的针规格通常受限于将针从药瓶插入和抽出时针的针管强度。长、细的针在试图刺穿药瓶的隔膜时更易于弯曲。因此，通过抽吸填充的固定针注射器具有比所需规格更大规格的针，以避免针弯曲。
此外，针规格在从另一容器中抽吸药物溶液时也是一个限制因素，这是因为流体从药瓶进入注射器的流动部分地是由针的内径和长度、药物溶液的粘度、以及引起流体流动的、可利用的压差所决定；在抽吸过程中最大的压力为大气压。与低粘度的药物相比，高粘度的药物需要更大内径的针，从而需要更大规格的针，以在合理长的时间内从药瓶中抽吸药物溶液进入注射器。再次，通过抽吸填充的固定针注射器通常具有比所需规格更大规格的针，以避免填充延迟。
许多药物可使用其中具有固定针注射器的自动注射装置进行注射。通常的自动注射装置允许未经过医学培训的使用者通过手动触发自动注射装置而自动注射药物。一些现有的自动注射装置还可在注射后自动缩回针。
因此，本申请认为，人们一直需要克服或减轻现有装置的前述和其他缺陷的固定针注射器和自动注射装置。
发明内容
本申请公开内容的一个目的在于提供一种具有小规格针的、使用者填充的(user-filled)固定针注射器。
本申请公开内容的另一目的在于提供一种固定针注射器，该固定针注射器可以装载流体药物而不需要通过与后来用于刺入组织并为进入注射部位的流动提供导管的同一针抽吸药物。
本申请公开内容的另一目的在于提供一种固定针注射器，该固定针注射器消除了现有技术中双用皮下注射针有关的对皮下注射针尺寸的限制，即现有技术要求同一针既用作从原始药瓶进入固定针注射器的导管，也用作从固定注射器进入注射受试者的导管。
本申请公开内容的又一目的在于是提供一种尾部可装载的药物室，该药物室具有带螺纹的内部区和可刺穿膜的可动活塞。
本申请公开内容的又一目的在于提供一种具有带自密封、可刺穿膜的可动活塞的固定针注射器。
本申请公开内容的又一目的在于提供一种具有与可动活塞可移动地连接的注射器导向装置的药物室，该注射器导向装置具有容纳皮下注射针的内径，该皮下注射针用于刺穿活塞膜以及通过刺穿膜刺穿填充药物室。
通过一种具有药物室、皮下注射针、柱塞和活塞的固定针注射器实现本申请公开内容的这些目的和其它目的。皮下注射针与药物室流动连通。活塞可滑动地设置在药物室中。柱塞与活塞可移动地固定。柱塞具有经由其中限定的孔，所述孔允许通过柱塞通向活塞。
还提供了一种注射药物的方法，所述方法包括通过固定针注射器的中空柱塞和活塞元件将药物从药物输送针推入固定针注射器的药物室中；从活塞取去中空柱塞；在第一组件中插入固定针注射器以使皮下注射针紧接第一组件的下密封体；固定第二组件与第一组件以使第二组件的从动杆紧接活塞元件。
还提供了一种注射成套工具。该注射成套工具包括注射组件、缩回组件和尾部可装载的固定针注射器。
根据随后的详细描述、附图和所附权利要求，本领域技术人员可以理解和获知本申请公开内容的上述及其他特征和优点。
附图说明
图1是根据本申请公开内容的固定针注射器的示例性实施方案的剖视图；
图2是图1的固定针注射器与自动注射装置一起使用的部分分解的立体图；以及
图3是图2的完整装配的自动注射装置的剖视图。
具体实施方式
参照附图，特别是参照图1，示出了根据本申请公开内容的固定针注射器10的一个示例性实施方案。注射器10包括与药物室14流动连通的皮下注射针12。在一些实施方案中，注射器10可以包括可拆卸的、设置在皮下注射针12上的保护套16。
注射器10还包括可滑动地设置在药物室14中的活塞18。优选地，注射器10包括在药物室14的尾端22处的注射器端帽20以防止活塞18从药物室中意外退出。
有利地，注射器10设置成使室14可以通过活塞18填充药物。
本申请的公开内容已经确定：皮下注射针的尺寸受限于在抽吸过程中施加在皮下注射针12上的力。有利地，注射器10使在抽吸过程中施加在皮下注射针12上的力与在注射过程中施加在皮下注射针12上的力分离。这样，可以减少皮下注射针的尺寸。
因此，皮下注射针12不需要做成具有足以承受将皮下注射针插入药瓶所产生的压力的针管强度的尺寸。此外，皮下注射针12的尖端也不会存在由于插入药瓶导致其变钝的风险。鉴于上述结果，可以减少皮下注射针12的尺寸，而在向患者注射的过程中仍然保持足够的流动性。
注射器10具有小内径和外径的皮下注射针12，该皮下注射针12可减少使用者在针插入和注射过程中的不适感。优选地，皮下注射针12的内径和外径与注射药物的粘度和在注射过程中施加在皮下注射针上的针管力-而不是在抽吸过程中施加在皮下注射针针管上的力相匹配。
在一些实施方案中，皮下注射针12的长度直径比最大程度地减少针插入使用者所产生的不适感。此处使用的长度直径比定义为由英寸表示的皮下注射针的长度除以以英寸表示的皮下注射针的外径的值。此处，皮下注射针12的长度直径比仅受限于在注射部位穿透组织所需要的强度。皮下注射针12可以具有至少约60的长度直径比。在一些实施方案中，皮下注射针12的长度直径比可达约120。优选地，皮下注射针12的长度直径比约为85。因此，皮下注射针12的长度直径比可在约60至约120之间，以及其间的任何子范围。
在其它实施方案中，皮下注射针12的流量比低于在一定的操作时间内药物室14经由抽吸、通过针管可被填满的水平。此处使用的流量比定义为在抽吸过程中通过皮下注射针的、以每分钟立方厘米(cc/分钟)表示的最大流量除以与以英寸表示的皮下注射针的长度的值。在常压下，抽吸过程中的最大压差为海平面上约14.7磅每平方英寸。此处使用的，一定的操作时间小于约30秒。因此，如果经由抽吸填满药物室14所花的时间长于30秒，那么可以认为，其对本申请的目的而言是不实用的。
皮下注射针12的流量比可小于约2.0。在一些实施方案中，皮下注射针12的流量比可小于约1.8。优选地，皮下注射针12的流量比小于约1.5。由于经由抽吸通过皮下注射针12不填满药物室14，注射器10有利地不受限于高的流量比，而是可以具有小于约2.0的流量比。
例如，在流量比小于约2及针长度约为1英寸时，皮下注射针12在抽吸过程中的最大流量小于约2cc/分钟。
注射器10包括通过注射器端帽20中的通过开口26可动地设置的柱塞24。在一些实施方案中，柱塞24与活塞18可拆卸地固定。例如，活塞18可包括内螺纹28，而柱塞24可以包括相应的外螺纹38。通过这种方式，螺纹28、38可用于选择性地固定和/或不固定柱塞24和活塞18。
柱塞24包括经由其中限定的中空孔或孔30。有利地，孔30允许通过杆体24(rod)通向柱塞18。优选地，孔30包括限定在其中的一个或多个针导向面32。在使用中，用于代替注射的皮下注射针12以从供给容器中抽取药物溶液的输送针(未示出)插入孔30中，通过活塞18而进入药物室14。活塞18由自密封、可刺穿的材料制成，例如那些通常用作药瓶间隔膜的材料，以及可包括但不限于诸如硅树脂或丁基橡胶的材料。
通过这种方式，可通过活塞18在尾端20填充室14。导向面32，如果存在，可以协助将输送针导入活塞18中。
一旦填满药物室14，输送针(未示出)可以从孔30中、通过活塞18从药物室14退出。通过简单地转动注射器10以使空气紧接皮下注射针12(例如，皮下注射针12为垂直定向)，并且压下柱塞24以通过皮下注射针12排除空气，可除去药物室14内的任何空气或其它气体。在使用中，使用者简单移除保护套16，如果存在，将皮下注射针12插入体内，下压柱塞24以从室14中注入所需剂量的药物。
在一些实施方案中，柱塞24可以包括一个或多个把手部34。把手部34可用于在填充和/或使用注射器10的过程中稳固柱塞24。
除了上述的、在手动注射过程中有用外，通过本申请公开的内容可以预期注射器10可与自动注射装置和缩回装置40一起使用，例如图2和图3所示。
一些自动注射装置具有产生比在活塞上通常由手施加的力更大的力的能力，这使得与人手可以实现的注射流量相比，可使用更小的皮下注射针而实现相同的注射流量。本申请公开的内容已经确定：如果排除与通过小规格皮下注射针抽吸药物有关的上述限制，本申请的设计特征更易于发挥注射容易接受的优点。
如图2和3所示，装置40包括力量注射组件42和力量缩回组件44。通过使用具有上述关于注射器的具有较小外径的皮下注射针12的注射器10，装置40减少了注射产生的组织损害和不适感。
当需要使用装置40时，注射器10可以上述的方式填充。接下来，可以从注射器10移除柱塞24，并且一旦移除护套16，注射器就可以可操作地设置在装置40中。
优选地，装置40为一种自动注射装置，该自动注射装置从该装置内伸出皮下注射针12，从室14中将单一的、预定剂量的药物注射入使用者体内并且在完成注射后自动缩回皮下注射针至组件中。
注射组件42可以基本上如2003年6月20日提交的、申请号为10/601,212的、共同所有且受让的美国申请所公开的内容操作，该申请的内容通过引用并入本申请。
可选地，注射组件42可如图2和图3所示出的那样。此处，注射组件42包括注射弹簧46、从动杆48、启动钮50、分离装置52和联结器54。
注射弹簧46在弹簧座49和联结器54之间绕从动杆48设置，联结器选择性地使注射弹簧与从动杆48接合。
启动钮50设置成选择性地将注射弹簧46中的能量释放至从动杆48。在所图示的实施方案中，从动杆48包括锁定端56和驱动端58。驱动端58设置成作用于活塞18以从室14中推动药物，这将在下面详细描述。
在一实施方案中，锁定端56包括两个或多个尖齿60，所述齿尖60弹性地偏向外侧，以使尖齿相互远离。当相互偏置时，尖齿60与弹簧座49上的锁定表面62接合。启动钮50包括一释放表面64。沿注射方向66施加在启动钮50上的作用力使释放表面64相对地压缩齿尖60，以使从动杆48脱离锁定表面62。
注射弹簧46在通常压缩或受压的条件下保持在弹簧座49和联结器54之间。一旦释放齿尖60，弹簧46中存储的能量作用于弹簧座49和联结器54上，以沿注射方向66驱动从动杆48。
注射弹簧46沿注射方向66驱动从动杆48，直至联结器54与分离装置52邻接。分离装置52作用于联结器54上的作用力使联结器脱离从动杆48。联结器54从从动杆48的脱离使从动杆不受注射弹簧46的作用力的约束，从而允许从动杆通过力量缩回组件44在与注射方向66相反的方向移动。
装置40可以设置成从室14中，肌内地、眼间地(interoccularly)、皮下和/或皮层内地注射药物。例如，分离装置52可固定在注射组件42内以沿注射方向66移动。通过改变分离装置从从动杆48解开注射弹簧46的点而沿注射方向66改变分离装置52的位置可以改变注射组件42的冲程。
在图示的实施方案中，注射组件42包括设置在启动钮50上的帽68。帽68可以减缓启动钮50的意外下压，从而防止注射组件42的过早启动。
在一优选的实施方案中，注射组件42和缩回组件44以扣合的方式相互固定以使组件在装配后不能相互移动。例如，注射组件42可以包括一个或多个向外支持的突出体68，所述突出体68容纳于限定在缩回组件44中的相应数量的开口70中。当注射组件42插入缩回组件44中时，突出体68作用于缩回组件，以使管的内部尺寸发生弹性形变。一旦开口70容纳突出体68，缩回组件44的内部尺寸恢复至其原始的尺寸以在开口中固定突出体。
在装配状态下，注射组件42和缩回组件44优选地保持室14在其间密封。例如，注射组件42可以包括密封件72，例如但不限于0型环。一旦注射组件42和缩回组件44固定在一起，密封件72就与缩回组件的内部配合以形成径向密封。在图示的实施方案中，密封件72设置在开口70下方，以在突出体68和开口70之间的扣合连接下方提供密封。
力量缩回组件44包括第二或缩回弹簧74和下密封体76。缩回弹簧74大大弱于注射弹簧46。当装配时，针12与下密封体76紧接设置。在使用过程中，注射弹簧46克服缩回弹簧74的力以沿注射方向66压缩缩回弹簧和移动室14，以使针12刺穿下密封体76和注射部位的组织。此外，注射弹簧46沿注射方向66推动从动杆48的驱动端58以通过针12将药物从室14中排出。
在活塞18已经运动至完成从室14中注射药物的位置，从动杆48沿注射方向66已经移动了足够的距离以使联结器54与分离装置52接触，这使联结器与从动杆脱离，并且终止了注射弹簧46对从动杆的影响。一旦注射弹簧46脱离，此时压缩的缩回弹簧74沿与注射方向66相反的方向推动针12、室14和从动杆48直至针退回下密封体76后。
在所述实施方案中，当注射组件42和缩回组件44不变地相互固定时，针12缩回至缩回组件使装置40避免引起针12造成的意外损伤，从而使装置40安全地被处理。
在本申请公开内容的一个实施方案中，装置40和注射器10可以用于装配和使用的最终灭菌的成套工具(未示出)的未装配的状态提供。此处，所述成套工具可以包括注射组件42和缩回组件44以及注射器10。此外，为方便使用者，所述成套工具可以包括一个或多个注射部位清洁药签，例如预包的酒精药签。例如，注射组件42、缩回组件44，注射器10可以包含在一密封的包中，例如一塑料或TYVEC包。在一些实施方案中，所述包可最后灭菌。
还应该指出，此处使用的术语“第一”、“第二”、“第三”、“上”、“下”以及类似的术语用于修饰各种元件。除非特别指出，这些修饰语不意味修饰元件的空间的、顺序的或等级的顺序。
尽管参照一个或多个示例性的实施方案已经描述了本申请公开的内容，但是本领域技术人员可以理解，对其元件可以进行各种变化，以及以等同物进行替换，而不偏离本申请公开内容的范围。此外，根据公开内容的教导，为适应特定的情形或材料可以做出许多修改而不偏离本申请公开内容的范围。因此，本申请公开内容并不意欲受限于作为预期最佳实施方式的具体实施方案，而是将包括落入所附权利要求范围内的所有实施方案。

Claims (22)

1.一种固定针注射器，所述固定针注射器包括：
药物室；
与所述药物室流动连通的皮下注射针；
可滑动地设置在所述药物室中的活塞；以及
与所述活塞固定的柱塞，所述柱塞具有经由其中限定的孔，所述孔允许通过所述柱塞通向所述活塞。
2.根据权利要求1所述的固定针注射器，其特征在于，所述固定针注射器还包括在所述药物室尾端的一端帽，所述端帽防止所述活塞从所述药物室退出。
3.根据权利要求1所述的固定针注射器，其特征在于，所述柱塞与所述活塞可移动地固定。
4.根据权利要求3所述的固定针注射器，其特征在于，所述柱塞与所述活塞通过螺纹连接可移动地固定。
5.根据权利要求1所述的固定针注射器，其特征在于，所述固定针注射器还包括一个或多个限定在所述柱塞的所述孔中的针引导表面。
6.根据权利要求1所述的固定针注射器，其特征在于，所述活塞为自密封、可刺穿的材料。
7.一种固定针注射器，所述固定针注射器包括：
药物室；
可滑动地设置在所述药物室中的自密封活塞；与所述药物室流动连通的皮下注射针；所述皮下注射针的长度直径比在约60至约120之间；以及
与所述自密封活塞固定的柱塞，所述柱塞具有经由其中限定的孔，所述孔允许通过所述柱塞通向所述自密封活塞。
8.根据权利要求7所述的固定针注射器，其特征在于，所述长度直径比为约85。
9.根据权利要求7所述的固定针注射器，其特征在于，所述皮下注射针的流量比小于约2。
10.一种固定针注射器，所述固定针注射器包括：
药物室；
可滑动地设置在所述药物室中的自密封活塞；与所述药物室流动连通的皮下注射针；所述皮下注射针的流量比小于约2的流速比；以及
与所述自密封活塞固定的柱塞，所述柱塞具有经由其中限定的孔，所述孔允许通过所述柱塞通向所述自密封活塞。
11.根据权利要求10所述的固定针注射器，其特征在于，所述流量比少于约1.8。
12.根据权利要求10所述的固定针注射器，其特征在于，所述流量比少于约1.5。
13.根据权利要求10所述的固定针注射器，其特征在于，所述皮下注射针的长度直径比在约60至约120之间。
14.一种注射药物的方法，所述方法包括：
通过所述固定针注射器的中空的柱塞和活塞将药物输送针导入固定针注射器的药物室中；以及
将药物从所述药物输送针推入所述药物室中。
15.根据权利要求14所述的方法，其特征在于，所述方法还包括：
从所述活塞移除所述中空柱塞；
在第一组件中插入所述注射器以使所述固定针注射器的皮下注射针紧接所述第一组件的下密封体；以及
将第二组件与所述第一组件固定，以使所述第二组件的杆体紧接所述活塞。
16.根据权利要求15所述的方法，其特征在于，所述方法还包括：
在注射部位上放置所述下密封体；以及
在所述第二组件中释放注射弹簧以沿注射方向驱动所述杆体，所述杆体推动所述皮下注射针穿过所述下密封体而进入所述注射部位，并且推动所述活塞以从所述药物室中通过所述皮下注射针排出所述药物。
17.根据权利要求16所述的方法，其特征在于，所述方法还包括当所述杆体沿所述注射方向移动时，推动所述第一组件的缩回弹簧至压缩状态。
18.根据权利要求17所述的方法，其特征在于，所述方法还包括：将所述注射弹簧从所述杆体脱离，以使所述缩回弹簧沿与所述注射方向相反的方向推动所述皮下注射针通过所述下密封体。
19.一种注射成套工具，所述注射成套工具包括：
尾部可装载的固定针注射器；
注射组件；以及
缩回组件，所述注射组件和缩回组件设置成与所述注射器可操作地固定。
20.根据权利要求19所述的注射成套工具，其特征在于，所述注射成套工具还包括一个或多个注射部位清洁药签。
21.根据权利要求19所述的注射成套工具，其特征在于，所述注射成套工具还包括包含所述注射器、所述注射组件和所述缩回组件的包。
22.根据权利要求21所述的注射成套工具，其特征在于，所述包是最终灭菌的。
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WO2020152192A1 (en) * 2019-01-24 2020-07-30 Sanofi Drug delivery device

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US7758548B2 (en) 2010-07-20
EP1819387A2 (en) 2007-08-22
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WO2006063172A3 (en) 2006-07-27
AU2005313993A1 (en) 2006-06-15
US7674246B2 (en) 2010-03-09
MX2007006974A (es) 2007-10-11
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EP1819380A4 (en) 2012-05-30
IL183767A0 (en) 2007-09-20
CN101180090A (zh) 2008-05-14
CA2591278A1 (en) 2006-06-15
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WO2006063123A3 (en) 2006-08-17

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