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CN105816942A - 具有剂末视觉指示器的自我注射器 - Google Patents

具有剂末视觉指示器的自我注射器 Download PDF

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CN105816942A
CN105816942A CN201610045119.XA CN201610045119A CN105816942A CN 105816942 A CN105816942 A CN 105816942A CN 201610045119 A CN201610045119 A CN 201610045119A CN 105816942 A CN105816942 A CN 105816942A
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autoinjector
drug container
injection
visual detector
circular cylinder
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CN105816942B (zh
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保罗·班森
理查德·D·吉莱斯皮·Iii
汤米·G·大卫
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West Pharmaceutical Services Inc
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    • A61M5/00—Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
    • A61M5/50—Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests having means for preventing re-use, or for indicating if defective, used, tampered with or unsterile
    • A61M5/5086—Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests having means for preventing re-use, or for indicating if defective, used, tampered with or unsterile for indicating if defective, used, tampered with or unsterile
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    • A61M5/3243—Means for protection against accidental injuries by used needles being axially-extensible, e.g. protective sleeves coaxially slidable on the syringe barrel
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    • A61M5/00—Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
    • A61M5/50—Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests having means for preventing re-use, or for indicating if defective, used, tampered with or unsterile
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • 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
    • A61M5/00—Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
    • A61M5/178—Syringes
    • A61M5/20—Automatic syringes, e.g. with automatically actuated piston rod, with automatic needle injection, filling automatically
    • A61M2005/206—With automatic needle insertion
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
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    • A61M2205/00—General characteristics of the apparatus
    • A61M2205/58—Means for facilitating use, e.g. by people with impaired vision
    • A61M2205/583—Means for facilitating use, e.g. by people with impaired vision by visual feedback
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • 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
    • A61M5/00—Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
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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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    • A—HUMAN NECESSITIES
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    • A61M5/00—Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
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    • A61M5/32—Needles; Details of needles pertaining to their connection with syringe or hub; Accessories for bringing the needle into, or holding the needle on, the body; Devices for protection of needles
    • A61M5/3205—Apparatus for removing or disposing of used needles or syringes, e.g. containers; Means for protection against accidental injuries from used needles
    • A61M5/321—Means for protection against accidental injuries by used needles
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    • A61M5/00—Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
    • A61M5/50—Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests having means for preventing re-use, or for indicating if defective, used, tampered with or unsterile
    • A61M5/508—Means for preventing re-use by disrupting the piston seal, e.g. by puncturing

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Abstract

本发明提供一种自我注射器，其自动地缩回容纳在其中的针，其包括具有柱塞和联接至柱塞的可移动活塞的注射组件、联接至注射组件的缩回组件和设置在缩回组件内的剂末视觉指示器。缩回组件包括不透明部分、联接至不透明部分的透明或半透明部分和具有注射针的药品容器。剂末视觉指示器被设置在缩回组件内使得在包含在药品容器内的药液或药物完全给予时，指示器从缩回组件的不透明部分向上移动至缩回组件的透明或半透明部分。剂末视觉指示器可根据许多优选的实施例进行配置，其中可以包括中空圆柱体、分离的指示器环、共挤环和多面多边形圆柱体。

Description

具有剂末视觉指示器的自我注射器
技术领域
本发明的领域涉及自动注射装置，即自我注射器(autoinjector)，且尤其涉及包括一个或多个剂末视觉指示器(end-of-dosevisualindicator)的自我注射器。
背景技术
也被称为“自我注射器”的自动注射针筒包括提供可注射的药液或药物的易用且自动给药的特征。自我注射器通常被设计为具有推笔(push-pen)设计。推笔设计允许个人在按下按钮或在激活启动自我注射的类似的触发部时正确地启动自我注射。这样，自我注射器相当容易地使用，尤其是在个人可能正在经历会使利用传统针筒的自我注射困难的紧张、疼痛和/或其它医学疾病的时候。
一些类型的自我注射器设置有预先装载在诸如针筒或药筒的药品容器中的药液或药物。当药液或药物被预先装载时，具有预定的标准化的单位剂量的自我注射器通常被售出。在没有标志完整剂量已被给予的明显可视的、可听的和/或可触的指示的情况下，使用者可能变得困惑或不耐烦并且过早地将自我注射器从注射位置移除，损失一部分药物。为了解决这个问题，在现有技术中描述的一些自我注射器，尤其是不缩回的自我注射器，具有使用者保持注射器对着使用者的注射位置比完成注射实际需要的时间更长的时间的用法说明。为了遵守这些用法说明，使用者必须因此常规地经历比实际需要更长时间的驻留在注射位置内的注射针的不适和疼痛。
因此，其中，存在对允许使用者清楚地确定什么时候药物的剂量已经被完全地输送的改进的自我注射器的需求。本发明的实施例满足该需求并且提供进一步相关的优势，如本文中所述。
发明内容
根据本文中描述的优选实施例，自我注射器包括具有柱塞和联接至柱塞的可移动活塞的注射组件、联接至注射组件的缩回组件和具有近端和远端且远端被配置为容纳剂末视觉指示器的可注射药品容器。优选地，缩回组件包括不透明部分和联接至不透明部分的透明或半透明部分。剂末视觉指示器被设置在缩回组件内并被配置为与药品容器的远端配合并且在包含在药品容器内的药液或药物的给予和药品容器的缩回完成时，与药品容器一致地从缩回组件的不透明部分内移动进入缩回组件的透明或半透明部分。所述剂末视觉指示器可以大量的实施方式来配置；其中优选的实施方式为中空圆柱体、分离的中空圆柱体、具有至少两种不同材料组分的共挤环和多面多边形圆柱体。
附图说明
当结合附图阅读时，前述概要与下面本发明的详细描述将被更好地理解。为了说明本发明的目的，在附图中示出目前优选的实施例。然而，应该理解的是，本发明并不限于所示的精确的配置和手段。
在附图中：
图1是根据本发明的优选实施例在注射前的自我注射器的正视透视图；
图2是图1中所示的自我注射器在注射期间的正视透视图；
图3是图1中所示的自我注射器在注射后和药液或药物的完全给予后的正视透视图；
图4是剂末视觉指示器的第一实施例的正视透视图；
图5是剂末视觉指示器的第二实施例的正视透视图；
图6是剂末视觉指示器的第三实施例的正视透视图；
图7是图1中所示的自我注射器的局部稍微放大正视图；
图8是图7中所示的自我注射器沿图7的线8-8的剖面图；
图9是图2中所示的自我注射器的局部稍微放大正视图；
图10是图9中所示的自我注射器沿图9的线10-10的剖面图；
图11是图3中所示的自我注射器的局部稍微放大正视图；以及
图12是图11中所示的自我注射器沿图11的线12-12的剖面图。
具体实施方式
现在将详细地参照附图中所示的本发明的实施例。在任何可能的情况下，相同或相似的参考数字在整个附图中将被用于指相同或相似的特征。应该注意的是，附图是以简化的形式绘制而并未被绘制为精确的比例。
关于本文中的公开，只为了便利和清楚的目的，结合以下附图的描述所使用的方位术语不应被理解为以未明确提出的任何方式限制本发明的范围。除非在本文中明确地提出，否则术语“一”、“一个”和“所述”并不限于一个元件而是应被解读为意为“至少一个”。术语包括以上提到的词语，其衍生物和相似含义的词语。还应注意的是，术语“第一”、“第二”、“第三”、“上方”、“下方”等在本文中可被用于修饰各种元件。这些修饰并不意味对修饰元件的空间的、顺序的、或分层的次序，除非明确阐明。
参照附图且尤其参照图1-3和图8，示出优选地能够通过具有附着的针30的药品容器40的自动注射药液或药物2和在完成注射后自动缩回药品容器40/针30的类型的自我注射器10。其它优选的自我注射器实施例被考虑，如专利号为8,123,724的美国专利中的说明性示例所描述的实施例，其中描述了具有分离的针的药品药筒，而不是具有附着的针的针筒。除其它元件外，自我注射器10包括的盖11、注射组件12、缩回组件16、包括药品容器40的药品容器组件17、注射针30和可移动活塞14。药品容器组件17为药物或药液2提供外壳。自我注射器10还限定用于对使用者的注射位置的落点的注射端或远端20和用于在一些优选的实施例中使用驱动按钮26驱动注射组件12的驱动端或近端22。为了解释的目的，示出不包括通常包含在含有药液或药物2的自我注射器中的所有特征(例如药筒和弹簧)的自我注射器10。
在使用期间，自我注射器10经过至少三个阶段：(1)预注射阶段(图1)；(2)注射阶段(图2)；以及(3)注射后的针缩回阶段(图3)。在第一、预注射阶段(图1)期间，盖11首先被从注射端20移除。参照图1、图7和图8，驱动按钮26还未被推动并且剂末视觉指示器18和针30被容纳在缩回组件16的不透明部分16a内。在图8中，示出包含药液或药物2的药品容器40的局部视图。
在第二、注射阶段期间，如图2、图9和图10中所示，盖11已经被移除，注射端20与使用者的皮肤接合(未示出)，驱动按钮26已经被推动，并且药品容器40向远端移动以与剂末视觉指示器22接合。在针30被永久地附着到药品容器40的实施例中，当药品容器40向前移动时，针30的一部分伸出缩回组件16的不透明部分16a的远端20并且进入到注射位置(未示出)即注射的接受者的组织中。一旦药品容器40向前延伸至完全地远端的位置，于是针30从缩回组件16向外突出至自我注射器10的物理约束可允许的最大程度，药物或药液2被迫通过针30从药品容器40离开并且进入使用者的注射位置。在注射阶段期间，剂末视觉指示器18保持被缩回组件16的不透明部分16a隐藏(如图10中所具体示出的)；然而，剂末视觉指示器18和药品容器40之间的接合已经被建立。
图3、图11和图12示出在第三、注射后且缩回阶段期间的自我注射器10。在该最后阶段，现在物理地与药品容器40接合的剂末视觉指示器18已经和药品容器40一致地向近端移动至完全缩回的位置。一旦缩回，剂末视觉指示器18在缩回组件16的透明或半透明部分16b中变得可见。与此同时，被永久地附着到药品容器40的针30从缩回组件16的不透明部分16a的外部的伸出位置缩回到不透明部分16a的内部的缩回位置。在第三阶段期间，剂末视觉指示器18(图3)在自我注射器10的透明或半透透明部分16b中被可视地显示，告知使用者注射完成，针30被缩回并且药液或药物2的完全剂量被给予。
注射组件12包括被配置以作用于缩回组件16的各种元件。为了简洁的目的，在考虑到与在本文中限定的本发明相关的自我注射器机构的优选实施例中所描述的这些元件、它们的配合相互关系和一般效用尤其在专利号为6,387,078、7,674,246、7,988,675、8,048,029和8,123,724的美国专利中被描述。上述专利中的每个的公开在此通过引用并入本文。
在上述专利中所描述的类型的注射组件除了其它元件外通常包括注射弹簧(未示出)、可移动活塞14、联接至可移动活塞14的柱塞24和被配置为作用于柱塞24的驱动按钮26。在一些注射组件中，在预注射阶段期间，注射组件12的元件的一部分被容纳在上部壳体38内。柱塞24还可包括连接柱塞24和可移动活塞14的集成联接器28。驱动按钮26可进一步被限定在激活端22处且包括上端32和下端34。在一些注射组件中，上端32可从注射组件12向外突出，同时下端34可从远端向内伸入注射组件14中。下端34也被联接至所述柱塞24以释放存储在注射弹簧中的能量并在注射方向36上推动柱塞24。柱塞24的驱动端36(图9和图11)也可被配置以作用于缩回组件16。例如，当柱塞24和可移动活塞14在注射弹簧的影响下向注射方向36移动时，缩回组件16可被激励。
在本文公开的注射组件中，缩回装置16包括不透明部分16a、具有设置在不透明部分16a内的一部分的透明或半透明观察部分16b、针30、具有保持针30的针座42的透明或半透明药品容器40、缩回弹簧(未示出)和拱壁44。可选地，拱壁可被合并为在拱壁44的近端设置的表面的轴向位置上的缩回组件16的最内部孔中的扩孔肩。拱壁44的功能是提供对剂末视觉指示器18的远端的轴向支撑。针30优选为包括入口部分46和组织穿透出口尖端48的注射针。诸如透明或半透明部分16b和透明或半透明药品容器40的缩回组件16的透明或半透明元件允许使用者可视地评估剂量给予的进度和当剂量已经被完全给予时观察剂末视觉指示器18。透明或半透明元件16b、40也可允许医疗提供者核实正确的剂量容量、核实药液还没有降低以及确定完整的剂量被给予。
在本文中所公开的注射组件12和缩回组件16优选地以滑入配合方式相互固定。这样，每个组件可包括相应的凸片和槽或提供滑入配合连接的其它结构。
图4至图6示出剂末视觉指示器18的示例性实施例。优选地，剂末视觉指示器18由提供与自我注射器10的总体颜色方案形成对比的例如橙色或绿色的明亮且明显的颜色的一种或多种材料制成。剂末视觉指示器18还可包括通过透明或半透明元件16b、40增加指示器18的可见性并提供美观价值的表面处理和/或图形或其它标记。
在图4中所示的第一实施例中，剂末视觉指示器18被配置为中空圆柱体18a。中空圆柱体18a优选地具有至少略微小于药品容器40的外径ODSB的内径IDVI。中空圆柱体18a的内径IDVI和药品容器40的外径ODSB之间的配合使得在自我注射器10的常规操作期间(即激活注射组件之前)防止圆柱体18a移动进入缩回组件16的透明或半透明部分16b中，如图7中所示。中空圆柱体18a的内径IDVI和药品容器40的外径ODSB之间的配合也不太紧以在注射阶段期间当注射组件12作用于药品容器40时防止药品容器40进入到中空圆柱体18a的内径IDVI，具体地如图9中所示。
在图5中所示的第二实施例中，剂末视觉指示器18被配置为分离的圆柱形指示器环18b，其包括在轴向方向在环18b的外边缘52a、52b之间完全延伸的槽或裂口50。这里，环18b具有也小于药品容器40的外径ODSB的IDVI。IDVI的范围提供更大的公差范围的变化，从而减小下列可能性：在注射阶段期间，指示器环18b会过早地进入透明或半透明部分16b，未能实现对指示器环18b的足够的干涉以固定到药品容器40，和/或防止药品容器40向前的移动。在注射阶段期间，槽间距SD的尺寸被设置为允许指示器环18b展开并容纳药品容器40的外径ODSB，具体地如图9中所示。在注射阶段期间由尺寸的干涉引起的指示器环18b的环向应力将压力施加在药品容器40的外径ODSB上以保证在缩回阶段期间药品容器将不滑出指示器环18b，如图11中所示。
在图6中所示的第三实施例中，剂末视觉指示器18被配置为共挤环18c。共挤环18c包括外部聚合物部分54和内部聚合物部分56。外部聚合物区54具有提供防止屈曲破坏并增加共挤环18c的环向应力的轴向刚度和弯曲模量的物料性质。内部聚合物部分56具有提供粘着性和附着力的物料性质。
在第四实施例(未示出)中，剂末视觉指示器18被配置为多面多边形圆柱体18d。多面多边形圆柱体18d包括多个片段19且每个片段19由弧长A和片段宽度W限定。多面多边形圆柱体18d具有最内部尺寸DVI，其在多边形的面上径向地被测量，其至少稍微小于药品容器40的外径ODSB。此外，片段的总弧长TA与药品容器40的外圆周长CDC大致相等。当药品容器40插入剂末视觉指示器中时，药品容器40将将引起容器40和圆柱体18d之间接触的力施加在多面多边形圆柱体18d上。该力将引起圆柱体18d变形并变得更圆，导致大约在每个片段19的中点处的径向向内设置的保持力。
如图1-2中所示的自我注射器10和自我注射器的其它变形可包括在本文中描述的剂末视觉指示器结构18a、18b、18c、18d中的任何一个。
尽管已经参照自我注射器和剂末视觉指示器的一个或多个示例性实施例描述了本公开，但本领域技术人员将理解的是，在没有脱离本公开的范围的情况下，可作出各种改变且等价物可代替用于其元件。此外，在没有脱离其范围的情况下，许多修改可被做出以使特定的情况或材料适应本公开的教导。因此，本公开并不旨在限于作为考虑的最佳模式所公开的具体实施例，而是本公开将包括落入权利要求的范围内的所有实施例。

Claims (11)

1.一种自我注射器，其包括：
注射组件，其包括柱塞和联接至所述柱塞的可移动活塞；
缩回组件，其被联接至所述注射组件，所述缩回组件包括不透明部分和联接至所述不透明部分的透明或半透明部分；
可注射药品容器，其具有近端和远端，所述远端被配置为容纳剂末视觉指示器；以及
剂末视觉指示器，其被设置在所述缩回组件内并被配置为与所述药品容器的远端配合和在包含在所述药品容器内的药液或药物的给予和所述药品容器的缩回完成时，与所述药品容器一致地从所述缩回组件的不透明部分内移动进入所述缩回组件的透明或半透明部分。
2.根据权利要求1所述的自我注射器，其中，所述自我注射器在预注射阶段、注射阶段和注射后的针缩回阶段中操作。
3.根据权利要求2所述的自我注射器，其中，所述剂末视觉指示器是中空圆柱体，所述中空圆柱体具有配合所述药品容器的外径的内径，并且所述中空圆柱体的内径与所述药品容器的外径之间的配合在所述预注射阶段大体上防止所述中空圆柱体移动进入所述缩回组件的透明或半透明部分。
4.根据权利要求2所述的自我注射器，其中，所述剂末视觉指示器是中空圆柱体，所述中空圆柱体具有配合所述药品容器的外径的内径，并且所述中空圆柱体的内径与所述药品容器的外径之间的配合在所述注射阶段允许所述药品容器的外径进入所述中空圆柱体的内径。
5.根据权利要求1所述的自我注射器，其中，所述剂末视觉指示器作为分离的指示器环，所述分离的指示器环具有在所述分离的指示器环的外边缘之间完全延伸的槽。
6.根据权利要求5所述的自我注射器，其中，所述槽限定槽间距的大小以允许所述指示器环展开并容纳所述药品容器的外径。
7.根据权利要求2所述的自我注射器，其中，所述剂末视觉指示器是共挤环。
8.根据权利要求7所述的自我注射器，所述共挤环包括外部聚合物部分和内部聚合物部分。
9.根据权利要求8所述的自我注射器，其中，所述外部聚合物部分具有轴向刚度和弯曲模量，当所述自我注射器从所述注射阶段进行至所述注射后的针缩回阶段时，所述轴向刚度和弯曲模量防止屈曲破坏并增加所述共挤环的环向应力。
10.根据权利要求8所述的自我注射器，其中，当所述自我注射器从所述注射阶段进行至所述注射后的针缩回阶段时，所述内部聚合物部分提供粘着性和附着力。
11.根据权利要求2所述的自我注射器，其中，当沿所述自我注射器的长轴观察时，所述剂末视觉指示器形状是多边形，所述多边形被限定使得径向向内设置的多边形面的总体长度略微小于所述药品容器的外圆周长。
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