CN104703640B - 笔型注射器装置 - Google Patents

笔型注射器装置 Download PDF

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Publication number
CN104703640B
CN104703640B CN201380052338.5A CN201380052338A CN104703640B CN 104703640 B CN104703640 B CN 104703640B CN 201380052338 A CN201380052338 A CN 201380052338A CN 104703640 B CN104703640 B CN 104703640B
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pen
cartridge case
type injector
conduit
injector device
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CN104703640A (zh
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托比·柯维
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Owen Mumford Ltd
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Owen Mumford Ltd
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    • A61M5/3129—Syringe barrels
    • A61M5/3134—Syringe barrels characterised by constructional features of the distal end, i.e. end closest to the tip of the needle cannula
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
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  • Health & Medical Sciences (AREA)
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  • Engineering & Computer Science (AREA)
  • Anesthesiology (AREA)
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  • Heart & Thoracic Surgery (AREA)
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  • Infusion, Injection, And Reservoir Apparatuses (AREA)

Abstract

公开了一种笔型注射器装置，该笔型注射器装置用于与药筒一起使用，以从药筒中输送多次单次计量剂量。所述注射器装置包括：主体，该主体设置为提供导管，在使用时，该导管提供在所述药筒与输送针之间的流体连通路径；以及设置为从所述药筒中排出治疗物质的机构。所述机构被设置为通过负压将治疗物质从所述药筒抽到所述导管中并且经由所述输送针从所述导管排出计量剂量。

Description

笔型注射器装置
技术领域
本发明涉及一种笔型注射器装置，尤其但非排他性地涉及用于从药筒注射计量剂量的例如胰岛素的治疗物质的装置。
背景技术
在例如Owen Mumford的传统笔型注射器中，包含例如胰岛素的治疗物质的药筒被容纳在连接至笔型主体的药筒保持器中。针通常可移除地连接至药筒保持器，用于输送治疗物质。笔型主体设置有布置用以经由针从药筒连续地排出单独计量的剂量的治疗物质的机构。这样的机构一般包括柱塞，该柱塞设置为接合药筒的活塞并且响应使用者按压释放按钮而向前移动预定的增量。应认识到，笔型注射器被设置为使用多个可重复的单独计量的剂量，并且通常每一个单个的剂量的容积可以是变化的。因此，该机构一般还包括例如刻度盘的计量选择器，以调节柱塞的运动。
笔型注射器需要具有紧凑的形式，以使得其可以被随身携带并且被不唐突地使用。此外，紧凑注射器可以易于制造、组装和使用，因此节省制造和组装成本以及带来更小的环境冲击。
发明内容
根据本发明的第一方面，其提供了一种笔型注射器装置，该笔型注射器装置用于与药筒一起使用，以从药筒中输送多次单独计量的剂量，所述注射器装置包括：
主体，该主体设置为提供导管，该导管在使用时提供在所述药筒与输送针之间的流体连通路径；以及
设置为从所述药筒中排出治疗物质的机构；其中所述机构被设置为通过负压将治疗物质从所述药筒抽到所述导管中并且经由所述输送针从所述导管排出计量剂量。
应认识到，本文中使用的术语“药筒”意图指的是在笔型注射器中用于容纳治疗物质的任何合适的容器。例如，该药筒可以包括注射筒。在可替代的实施例中，药筒可以与笔型注射器于一体地形成或是笔型注射器的一部分(例如注射器主体或壳体)。
在优选实施例中，所述机构被设置为通过正压力从导管排放计量的剂量。
因此，根据本发明的实施例的笔型注射器组件不需要柱塞机构来将治疗物质从药筒排出(而是，当排出流体时，所述机构提供的负压作用以向前拉动活塞)。优选地，这消除了必须具有足够的长度以容纳给柱塞提供使药筒的全部容积能够被排出的冲程的机构的已知的笔型注射器的总体尺寸的限制。这样，应认识到，传统的笔型注射器的长度至少是本药筒的长度的两倍。
此外或可替代地，在本发明的实施例中，移除了柱塞，使得更大容量的药筒可以用在传统尺寸的笔型注射器中。
所述主体可以包括被设置为阻止流体从所述导管流至所述药筒的止回阀。所述主体还可以包括设置为阻止流体从所述针流至所述导管的止回阀。一个所述止回阀或每一个止回阀可以被偏压至关闭位置。这样，只需要最小的压力差克服阀，就能够使得流体流至导管或从导管流出。
主体的前部可以适于容纳一次性输送针(例如一次性无菌针)。例如，所述主体可以设置有用于容纳卡扣配合或螺纹配合的一次性针组件的互连特征件。所述主体可以在导管的前端上设置有隔膜(通常为橡胶隔膜)，并且输送针可以是双端针，其中面朝后的针尖被设置为在使用时刺穿隔膜。
所述主体可以在其后端上设置有药筒针，该药筒针被设置为在组装笔型注射器组件时刺穿药筒的隔膜。药筒针的直径可以大于输送针的直径。相对大直径的药筒针使得从药筒抽流体至腔的限制减小，并且提供了有利的流动设置方式。
所述主体可以包括用于容纳药筒的壳体。
所述机构可以包括正排量泵。正排量泵式为使用其泵抽元件的每一个动作排出已知量的流体的泵。
在一些实施例中，正排量泵可以是旋转式泵。例如导管可以包括柔性管，并且所述机构包括蠕动泵。
在其它实施例中，所述机构包括往复泵。例如，所述机构可以包括活塞泵或隔膜泵。在一些实施例中，所述机构可以是机电的泵，例如压电式泵。可替代地，所述机构可以是被使用者机械地致动的(并且例如可以被弹簧加载)。
所述机构还可以包括与导管流体连通的排量腔。该排量腔可以包括缸，并且所述机构还包括释放按钮，该释放按钮被设置为移动所述缸内的活塞或隔膜。所述释放按钮可以例如机械地连接(例如刚性地连接)至所述活塞或隔膜。
可替代地，所述机构可以与所述主体一体地形成。例如，所述机构可以包括导管的第一部分，该导管的第一部分可以移动进导管的第二部分中，以减小导管的体积。例如，所述第一部分可以可滑动地安装在所述第二部分内(即，所述导管的多个部分可以以伸缩形式布置)。所述导管的多个部分可以朝向其展开位置被偏压。
所述机构还可以包括偏压装置，该偏压装置被设置为使活塞或隔膜返回其待发位置。应认识到，待发位置通常是活塞或隔膜未被压缩的位置，这样，在待发位置中，计量的剂量的治疗物质将从药筒被抽至导管中。
所述腔可以被设置在壳体的外周上。所述腔可以是大致细长形的并且可以与笔型注射器的纵向轴线大致对齐。例如，所述腔可以是大致环形的并且可以基本围绕壳体。细长的腔一般会导致相对小的表面面积排量以及相对大的排量移动。因为活塞或隔膜运动的小增量对应的仅是小容积，所以这有利地提供致动方面的机械优势并且还允许实现更大的剂量精度。
所述机构还可以包括剂量调节器，该剂量调节器被设置为使得使用者能够设置计量剂量的体积。所述剂量调节器可以被设置为调节泵的排量，例如所述剂量调节器可以设置泵的冲程。
可替代地，剂量调节器可以响应使用者按压释放按钮而调节泵的致动数量。例如，剂量调节器可以设置例如蠕动泵的旋转泵的旋转数。因此，应认识到，如本文中所谓的单独计量的剂量可包括所述机构的多个致动(因此，可以一定程度，由一系列连续的分离的排放组成)，但是，其是由使用者作出的笔型注射器的单次致动的结果。
本发明如上所述，同时它还扩展至上文或在下面的说明书或附图中提出的特征的任何发明组合。
附图说明
现在将参照附图并且仅通过示例详细描述本发明的具体实施例，其中：
图1是根据本发明的第一实施例的笔型注射器的三维的示意剖面图；
图2是根据本发明的第二实施例的笔型注射器的示意剖面图；以及
图3是根据本发明的第三实施例的笔型注射器的示意剖面图。
具体实施方式
本文中所使用的前部将被理解为指的是使用时最接近笔型注射器的输送针的输送端的笔型注射器组件(或其部件)的一端(即指向皮肤的一端)。本文中所使用的后部将被理解为指的是使用时最远离笔型注射器的输送针的输送端的笔型注射器组件(或其部件)的一端(即背离皮肤的一端)。同样，向前和向后将被理解为指的是朝向笔型注射器组件的前部和后部定向的方向。
图1示出了根据本发明的实施例的笔型注射器10的示意剖面图。笔型注射器10适于与例如胰岛素的治疗物质的药筒或注射筒20一起使用。笔型注射器包括壳体40，该壳体40容纳并支撑药筒20，并且限定导管42以在药筒20和输送针30之间提供流体连通路径。机构40被设置以响应使用者按压释放按钮60而从药筒20排出计量的剂量的治疗物质或药剂。
壳体40包括基本圆柱形的细长主体，该主体可以由注塑材料制成。壳体40从设置有外螺纹41以接收一次性针组件30的前部延伸至后端，后端被可移除端盖49封闭以允许药筒被插入或移除。在壳体40的药筒容纳部的前部上设置有支座47，该支座47将药筒20的头部24支撑并且对准在适当的位置，以使得药筒针48可以刺穿位于药筒20的前端24上的隔膜26。壳体40中的导管42自药筒针48延伸至输送针32。第一止回阀44设置在导管42的后部，以阻止从导管42进入药筒20中的反向流体流。第二止回阀46设置在导管42的前部，以阻止从针32至导管42的反向流体流。每一个止回阀44、46都可以由诸如乙缩醛(POM)的弹性材料制成，并且可以设置有压缩板簧或板形压簧形式的一体偏压装置，压缩板簧具有比导管42的直径更小的直径，从而不会阻碍流动。O形圈44a、46a设置为每一个阀44、46的支座以提供良好的密封接合。然而，应认识到的是，该阀可以设置有诸如直立(upstanding)构件或环的一体密封特征(可以例如使用具有带有热塑性弹性体密封构件的注塑偏压装置的两件式结构来提供一体密封构件)。
针组件30包括针保持器36，具有用于在壳体40的前部接合螺纹41的内螺纹37。所述针是双端的，提供朝向前的输送针32和朝向后的针34，该朝向后的针34被布置以刺穿导管42前部的隔膜(未示出)。
机构50包括排量腔(displacement chamber)52，该排量腔52限定在壳体的侧壁中并且与导管42流体连通。活塞54设置在排量腔52中并且与排量腔52的壁(经由围绕其圆周的O形圈)密封地接合。活塞54的活塞杆55延伸到腔52之外并且连接至释放按钮60(其基本上为杯形以配合在腔52的外部上并且封住活塞杆55)。例如不锈钢盘簧的复位弹簧56设置在按钮60与腔52之间，以朝向如图1a所示的活塞的待发位置偏压活塞(下文将更详细地说明)。由于与塑料弹簧相比不锈钢弹簧一般可以设定更高的阻力，所以不锈钢弹簧可以选优用于复位弹簧。
现在将具体参照图1a、1b和1c描述根据本发明的实施例的笔型注射器10的操作。在使用之前，必须通过移除端盖49将药筒20插进壳体40的后部中。当完全插入时，药筒的头部24坐落于支座47内并且药筒针48将刺穿药筒的隔膜26。无菌的针组件30被螺纹旋进笔型注射器10的前部上的螺纹41上的位置，以使得朝向后的针刺穿壳体前部上的隔膜。因此，导管42在药筒20与针30之间提供流体路径。图1a中示出了笔型注射器机构50的空闲位置，在该空闲位置，活塞54在排量腔52内位于其最高位置。在该位置，止回阀44、46都被其一体偏压装置保持关闭。
应认识到的是，当新的药筒20或针30被插入笔型注射器10中时，一般需要通过操作机构50(以如下所述的方式)来装填笔型注射器10，直至从导管40、针30和/或机构50中排出所有的空气。
如图1b所示，使用者朝笔型注射器10的主体按压释放按钮60沿箭头A的方向运动活塞54，以致动笔型注射器10。活塞使流体从腔52流至导管42中。导管42中产生的正压力使阀46沿箭头B的方向移离其支座，由此使计量的剂量(具有与排量腔的容积相对应的体积)经由针30排出。还应注意的是，导管中增加的压力作用在止回阀44的前表面上，由此有助于确保维持良好的密封(密封O形圈44a)，以阻止流体流回药筒20中。一旦剂量被输送，那么导管42中的压力将降低并且止回阀46由于一体的偏压装置的原因将返回其关闭位置(向后移动，沿图1c中示出的箭头E的方向)并且密封O形圈46a。
当使用者从释放按钮60抬起手指时，复位弹簧56使释放按钮60在箭头C的方向上远离笔型注射器10移动。结果，活塞54移出排量腔52。因此，活塞54在导管42中产生负压，该负压用作以使得阀44沿箭头D的方向远离其支座移动，由此使计量的剂量(具有与排量腔的容积相对应的体积)被从药筒20中抽到导管42中。还应注意的是，导管中压力的下降作用在止回阀46的后表面上(在箭头E的方向上推动止回阀46)，由此有助于确保较好地密封O形圈46a。随着流体被从药筒20中抽出，药筒活塞22在箭头F的方向上被向前拉动。一旦计量的剂量被抽到导管42(和与导管42流体连通的排量腔52)中，那么负压将降低，使得止回阀44由于一体的偏压装置的作用将(沿与箭头D相反的方向向后移动)返回其关闭位置并且将密封O形圈46a。
图2示出了根据本发明的另一实施例的笔型注射器210。该实施例利用了与图1的实施例相同的原理，但是其设置有与笔型注射器210的纵向轴线大致对齐的机构250。该机构包括排量腔252，该排量腔252具有环形的截面并且围绕壳体240的外周设置。至少一个流体连通端口设置在腔与导管242之间。活塞254具有与排量腔252互补的环形轮廓并且能够平行于(而不是如图1的实施例中所示的垂直)笔型注射器10的纵向轴线移动。
应注意的是，图2的实施例的止回阀246、244具有与图1的实施例的止回阀不同的截面。在该实施例中，每一个阀244、246都包括基本半球形的密封构件，该密封构件布置为密封锥形密封支座。这样的设置方式提供了对阀的任何倾斜低敏感度的密封接合方式(以及可以有效地自动对中)。
在需要输送可变剂量的治疗药剂的情况下，在前述实施例中的任一个中的活塞54、254的动作可以被改变，以改变机构50、250的单次致动往复带来的排量。例如，可以设置调节活塞54、254的冲程的剂量选择器。在最简单的剂量中，可以通过释放按钮60与活塞54之间的螺纹接合以使得可以通过旋转释放按钮来设定活塞54的返回位置提供剂量选择器。可替代地，可以提供如下的剂量选择器：该剂量选择器设置机械止动件的位置，以限制活塞54、254可以移动进入排量腔52、252中的程度。
图3示出了根据本发明的实施例的另一笔型注射器310。在该实施例中，导管342包括柔性管，并且机构350包括蠕动泵。蠕动泵350包括排量构件354，该排量构件354被设置为在导管342上移动并且压缩柔性管的一部分。该排量构件通常是连接至穿过管道旋转的旋转致动器355的辊，该管道被保持在限定在注射器笔310的壳体340内的大致圆形泵壳体中。随着辊354转动，在压缩下的管道342的一部分被挤压关闭，因此使压缩点前面的流体被推动通过导管并且从针330排出。此外，随着在辊354通过后管道342朝其自然状态展开，使得在管道中产生负压，该负压作用以将流体从药筒320抽进导管中。计量剂量的体积可以由辊354的旋转数和管道342的尺寸限定。
虽然已经参照一个或多个优选实施例描述了本发明，但是应认识到的是，可以在不脱离如附属的权利要求中所限定的本发明的范围的情况下作出各种变型或修改。
例如，本领域技术人员将认识到，虽然上述实施例涉及一种耐用(或可再填充)的笔型注射器，其中治疗药物的药筒(或注射筒)被设置为可更换(并且药筒本身不是本发明的必要特征)，但是其它笔型注射器也可以是一次性的(或预填装的)。例如一次性笔可以设置有位于笔内的药筒(或注射筒)并且是不可移除的，从而在全部治疗物质或药物已经从笔中被排出之后该笔被丢弃。
此外，本领域技术人员将认识到，上述实施例的笔型注射器装置接合药筒的特定设置方式不是必要的，其它设置方式可以落入本发明的范围内。通过示例，根据本发明的实施例的装置可以设置为多次或单次使用的附件的形式，该附件被附接至药筒(或注射筒)或包含药筒(或注射筒)的壳体。例如，该装置可以与针组件一体设置(例如，其中设置有导管的装置主体可以是针组件的主体)。

Claims (16)

1.一种笔型注射器装置，该笔型注射器装置用于与药筒一起使用以从药筒中输送多次单独计量的剂量，所述注射器装置包括：
主体，该主体容纳并支撑治疗物质的药筒，并在前端具有或容纳输送针，该主体限定导管和支座，该导管在使用时在与所述药筒相关联的药筒针和输送针之间提供流体连通路径，该支座用于容纳药筒的头部和布置以在所述药筒坐落于支座内时刺穿药筒的隔膜的药筒针；以及
与导管流体连通并布置为从所述药筒中排出治疗物质的机构；其中所述机构被设置为通过负压将治疗物质从所述药筒抽到所述导管中并且经由所述输送针从所述导管排出计量的剂量。
2.如权利要求1所述的笔型注射器装置，其中所述主体包括第一止回阀，该第一止回阀被设置为阻止流体从所述导管流至所述药筒，和设置为阻止流体从所述针流至所述导管的第二止回阀。
3.如权利要求1或2所述的笔型注射器装置，其中所述主体适于容纳一次性的输送针。
4.如权利要求1或2所述的笔型注射器装置，其中所述药筒针的直径大于所述输送针的直径。
5.如权利要求1或2所述的笔型注射器装置，其中所述主体包括用于容纳所述药筒的基本圆柱形的细长的壳体。
6.如权利要求5所述的笔型注射器装置，其中所述机构包括正排量泵。
7.如权利要求6所述的笔型注射器装置，其中所述导管包括柔性管，并且所述机构包括蠕动泵。
8.如权利要求6所述的笔型注射器装置，其中所述机构包括往复泵。
9.如权利要求8所述的笔型注射器装置，其中所述机构还包括与所述导管流体连通的排量腔。
10.如权利要求9所述的笔型注射器装置，其中所述排量腔包括缸，并且所述机构还包括释放按钮，该释放按钮被设置为移动所述缸内的活塞或隔膜。
11.如权利要求10所述的笔型注射器装置，其中所述机构还包括偏压装置，该偏压装置被设置为使所述活塞或隔膜返回其待发位置。
12.如权利要求9至11中任一项所述的笔型注射器装置，其中所述排量腔设置在所述壳体的外周上。
13.如权利要求9至11中任一项所述的笔型注射器装置，其中所述排量腔为大致环形的并且基本上围绕所述壳体。
14.如权利要求10或11所述的笔型注射器装置，其中所述机构包括导管的第一部分，其相对于所述导管的第二部分能够滑动地安装使得其能够位移进入导管的第二部分中以便减小导管的体积。
15.如权利要求8至11中任一项所述的笔型注射器装置，其中所述机构还包括剂量调节器，该剂量调节器被设置为使得使用者能够设置所述计量的剂量的体积，以及其中所述剂量调节器被设置为调节所述泵的冲程。
16.如权利要求1或2所述的笔型注射器装置，其中所述机构还包括剂量调节器，该剂量调节器被设置为响应于使用者按压释放按钮而调节所述机构的致动数。
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WO2014053849A2 (en) 2014-04-10
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EP2903667A1 (en) 2015-08-12
CN104703639B (zh) 2018-05-22
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US10159807B2 (en) 2018-12-25
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GB2510093A (en) 2014-07-30
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CN104703640A (zh) 2015-06-10
US20150265775A1 (en) 2015-09-24
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US20150273158A1 (en) 2015-10-01
WO2014053849A3 (en) 2014-08-07

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