CN204307160U - 单次使用式注射器械 - Google Patents

单次使用式注射器械 Download PDF

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Publication number
CN204307160U
CN204307160U CN201420463591.1U CN201420463591U CN204307160U CN 204307160 U CN204307160 U CN 204307160U CN 201420463591 U CN201420463591 U CN 201420463591U CN 204307160 U CN204307160 U CN 204307160U
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China
Prior art keywords
thumb button
pin
inspirator
storage chamber
shield
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CN201420463591.1U
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English (en)
Inventor
J·赫尔
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Becton Dickinson and Co
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Becton Dickinson and Co
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    • A61M5/178—Syringes
    • A61M5/31—Details
    • 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
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    • 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
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    • A61M5/285—Syringe ampoules or carpules, i.e. ampoules or carpules provided with a needle with sealing means to be broken or opened
    • A61M5/288—Syringe ampoules or carpules, i.e. ampoules or carpules provided with a needle with sealing means to be broken or opened by piercing without internal pressure increase
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    • A61M5/3158—Constructional features or modes of drive mechanisms for piston rods based on axial translation, i.e. components directly operatively associated and axially moved with plunger rod performed by axially moving actuator operated by user, e.g. an injection button
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    • 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
    • A61M5/50—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
    • A61M5/5013—Means for blocking the piston or the fluid passageway to prevent illegal refilling of a syringe
    • A61M5/502—Means for blocking the piston or the fluid passageway to prevent illegal refilling of a syringe for blocking the piston

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Abstract

本实用新型公开了一种预填充的单次使用式注射器械，在针的患者端部上包括被动式双屏蔽件。该器械是自足型的，从而在使用之后屏蔽整个针，而没有用于非患者端部的分立式被动屏蔽系统。

Description

单次使用式注射器械
技术领域
本实用新型属于用来输送药剂的注射器械的领域，具体地说，本实用新型涉及一种预填充式单次使用式器械，这种器械保护使用者或健康护理提供者，使得他们免受意外针刺扎。
背景技术
现有技术讲授了各种安全屏蔽系统，这些安全屏蔽系统适于供医用笔使用。被动屏蔽系统的例子包括在美国专利申请公开文本No.2011/0288491和No.2011/0257603中公开的那些，这两个专利申请公开文本通过参考而包括。在这些公开文本中公开的针组件适于连结到笔本体上，并且包括近侧或非患者侧针，该近侧或非患者侧针延伸到笔的药剂腔室中。除屏蔽患者侧针之外，这样的屏蔽系统可以包括用来覆盖近侧针的手动或被动致动屏蔽件，以防止当从笔本体除去屏蔽组件时的意外针刺扎。
随着填充的笔式器械和获准自行注射的其它组成的增长，对于单次使用式注射器械的需要相应地增加。本实用新型的目的是，将被动屏蔽保护的知识应用于可弃置的、单次使用式注射器械，该注射器械具有自足型(self-contained)构造，从而在使用之前和之后将针的患者端部被动地屏蔽，并且将针的非患者端部包含在器械内，以保护使用者或健康护理提供者，使他们免受针刺扎，而不需要在非患者端部上的被动屏蔽系统。
实用新型内容
在一个方面，本实用新型提供一种注射器械，这种注射器械包括承载针的毂座。毂座具有用来接合拇指按钮的近侧沟槽、和用来接合 屏蔽组件的远侧表面。屏蔽组件包括在针的径向外部的内部屏蔽件，该内部屏蔽件具有接合毂座的特征部。屏蔽组件还包括在内部屏蔽件的径向外部的外部屏蔽件，该外部屏蔽件用于将内部屏蔽件保持在初始位置中和将内部屏蔽件释放到覆盖着针的第二位置。屏蔽组件也包括在外部屏蔽件的径向外部的外部套筒。在使用之后，第一弹簧在覆盖针的远侧方向上偏压内部屏蔽件。包含药剂的小体积储腔设置在器械中，适于由针插管的近侧端部刺穿，以提供在储腔与针插管之间的流体连接。拇指按钮具有突起部，与在毂座上的近侧沟槽接合，并且将储腔包围在拇指按钮与毂座之间。拇指按钮在其近侧面上具有柱塞，该柱塞接合储腔，以从针的远侧端部分配药剂。
在另一个方面，本实用新型提供一种使用器械的方法，以通过注射而施用单次剂量的药剂，并且在使用之后被动地包含针的远侧和近侧端部。该方法包括：提供单次使用式注射器械，该单次使用式注射器械具有承载针的毂座，毂座具有用来接合拇指按钮的近侧沟槽、和用来接合被动屏蔽组件的远侧表面；包含药剂的小体积储腔，适于由针的近侧端部刺穿，以提供在储腔与针插管之间的流体连接；以及拇指按钮，具有突起部，与在毂座上的近侧沟槽接合，并且将储腔包围在拇指按钮与毂座之间，拇指按钮在其近侧面上具有柱塞，该柱塞接合储腔，以从针的远侧端部分配药剂。为了执行注射，患者或健康护理专业人员将单次使用式器械抵靠注射部位定位，并且按压拇指按钮，以通过注射而输送单次剂量。针的远侧端部在使用之后使用任何装置被动地屏蔽，这些装置包括以上描述的使用内部和外部屏蔽件的双屏蔽件实施例，该内部和外部屏蔽件绕毂座和针的远侧端部布置。因而，针插管的两个端部受到保护，在注射之前和之后将远侧端部被动地屏蔽，以防止来自针的远侧端部的意外针刺扎，并且在使用之后将针的近侧端部包含在拇指按钮与毂座之间，以保护使用者，使他们免受针的近侧端部的意外针刺扎。作为另外的益处，单次使用式器械能够防止交叉污染——该交叉污染可能由笔(该笔具有不同的笔针)的再次使用而引起。
如对于本领域的技术人员由如下详细描述将显然的那样，上述单次使用式器械及其使用方法的变化方式可以被适应和实践，而不脱离本实用新型的范围。
附图说明
图1描绘的是本实用新型的单次使用式注射器械的立体图。
图2是图1的器械的分解图。
具体实施方式
这里使用的“远侧”方向是在注射部位的方向上，并且“近侧”方向是相反方向。“轴向”方向是沿注射器械的纵向轴线。针插管一般轴向布置在器械中。“径向”是与轴向方向相垂直的方向。因而，“径向向内”一般是指离针较近。“整体”是指在由使用者通常遇到的状态下的单件，该单件被设计为不能被容易地拆开。
根据本实用新型的一个实施例的单次使用式器械100在图1中示出，在由使用者见到的状态下。针承载毂座10完全包含在屏蔽组件20内，从而屏蔽组件20本身的外部套筒28成为器械的本体。只有毂座10的唇边16坐在屏蔽组件外面，以便使用干涉配合、热焊接、粘合剂、它们的组合、或在业内已知的其它技术而连结。类似于诸如Autoshield DUOTM之类的现有屏蔽系统，屏蔽组件20可以包括外部屏蔽件26和内部屏蔽件24，该外部屏蔽件26覆盖在初始状态下的针，针在初始状态下从该内部屏蔽件24伸出。(针56在图1中未示出)。外部屏蔽件26在初始状态下保持内部屏蔽件24，并且能向近侧运动，以从初始状态释放内部屏蔽件24。各种可释放保持装置可以用来保持和释放内部屏蔽件24，如下文所述的那样。一旦被释放，内部屏蔽件24就由弹簧偏压到覆盖针的第二位置。内部屏蔽件优选地锁定在第二、使用后位置中的针外部上。两个屏蔽件都至少部分地由外部套筒28围绕。翼部22可以形成在外部套筒28的外表面上，以便为输送注射的使用者或健康护理提供者提供手指握持部。一般而言，内部屏蔽 件24、外部屏蔽件26及外部套筒28由注射模制塑料制成，如由聚丙烯制成。可以适用来自医用笔现有技术的制造材料和方法。
在图2的分解图中看到组件的更详细视图。代之以如在现有技术中那样的适应用于连结到笔本体上的毂座10，根据本实用新型的毂座10通过如下设计而适于单次使用操作：在毂座10上提供近侧开口12，以接纳拇指按钮30；和在拇指按钮30与毂座10之间提供预填充式小体积储腔40，该小体积储腔40包含药剂。根据一些优选实施例，在毂座中的开口12适于基本上接纳储腔的全部。
拇指按钮由突起部32导向，这些突起部32与在毂座的内表面上的沟槽34对接。在一些实施例中，突起部32和沿轴向定向的沟槽34配合，以当在注射期间按压拇指按钮时，使拇指按钮30轴向行进，而没有转动。在另一些实施例中，在毂座的内表面上的沟槽34沿周向定向，从而拇指按钮可在毂座的近侧开口12内转动。当然，轴向和周向凹槽都可以设置在毂座上，以引导拇指按钮在毂座中的运动。例如，在一个实施例中，拇指按钮30在第一位置中不能沿轴向运动，并且必须转动到这样的位置中：突起部32为了沿轴向运动而接合沿轴向定向的沟槽。因而，拇指按钮可以从不能注射的安全位置转动到能够注射的位置。尽管拇指按钮30可以在毂座10内运动，但拇指按钮在正常使用期间不能由使用者除去。单次使用式器械的一个优点是其总体紧凑性：在各实施例中，器械从拇指按钮的近侧端部到外部屏蔽件的远侧端部的长度可以小于60mm，容纳标准的4mm、5mm或8mm注射深度针。单次使用式屏蔽器械也可以供较长或较短的针使用，这些针包括真皮内注射深度针。
拇指按钮30直接与毂座10的对接，使得单次使用式注射器械具有对使用者友好的适应特性。例如，预填充储腔40可以接合至拇指按钮30，从而储腔40随拇指按钮在毂座中的开口12内转动。在毂座中的沟槽34可以构造成，将拇指按钮30在毂座10中转动允许储腔40从第一轴向位置运动到注射准备位置，在该第一轴向位置中，针插管的近侧端部不能刺穿储腔的隔膜44，在该注射-准备位置中，隔膜可 由拇指按钮刺穿。
在另一个实施例中，拇指按钮30和毂座10的对接允许使用者或健康护理提供者从多个剂量水平中选择。在这个实施例中，多个沿轴向定向的沟槽使得拇指按钮能够在毂座10内的以较长或较短距离沿轴向运动。依据拇指按钮的轴向位置的不同，在拇指按钮30上的柱塞36将塞子42接合到储腔上的不同轴向位置，从针56中排出对应剂量的药剂。
在另一个实施例中，拇指按钮设有锁定使用后位置。为了这个目的，可以提供在拇指按钮上的突起部，以与在毂座上的对应部分按锁定关系匹配。这些对应部分适于在拇指按钮的最远侧位置处锁定或者靠近该位置而锁定，该最远侧位置在施用注射之后到达。在锁定使用后位置中，拇指按钮不能被除去，并且拇指按钮不能进行向近侧、向远侧运动及/或转动运动。为了这个目的在毂座和拇指按钮上的对应部分的准确布置、尺寸及数量可以交给本领域的技术人员去判断。作为“在拇指按钮上的突起部接合在毂座上的凹口”这种方式的替代方式，可以在毂座上设置突起部，使之与在拇指按钮上的凹口相匹配。在锁定使用后位置中的对应部分的接合可以伴随有可听辨的咔哒声，该咔哒声用以表示注射完成。
拇指按钮可以包括多个元件。在一些实施例中，螺纹界面可以设置在拇指按钮与毂座之间，从而拇指按钮的元件随着将它向下推压而转动，类似于一些现有医用笔。典型地，拇指按钮的转动元件是分立地模制的塑料件，该塑料件布置在由使用者接触的外表面的下面。
单次使用储腔40比医用笔筒仓简单，因为它适于对于使用者预填充而装运。因而，不要求使用者将笔针安装在笔本体上。然而，类似于医用笔筒仓，储腔典型地包括隔膜44，该隔膜44在注射期间由针56的近侧端部刺穿。塞子42隔离储腔，并且可被推动，以将储腔的内装物加压，而从针56的远侧端部排出药剂。然而，能够由针刺穿和压缩以排出药剂的任何药剂容器都可以用来代替具有隔膜和塞子的上述筒仓，而不脱离本实用新型的范围，该药剂容器例如包括柔性塑料 平衡器(ballast)。供皮下输送的任何药剂可用的、单次使用系统便利地适于供固定剂量药剂使用，这些固定剂量药剂非限制性地包括肾上腺素(和其它激素类治疗物质)、基础胰岛素、胰升糖素状肽(GLP-1)、白细胞生长因子、诸如之类的骨质疏松药剂、诸如 之类的基于激素的糖尿病治疗剂、等等。
不同机构可以用来防止隔膜44在注射之前由针56刺穿。在一个实施例中，在针承载毂座10与预填充储腔40之间利用弹簧54。在按压拇指按钮30时，弹簧54压缩，并且针56的近侧端部将储腔隔膜44刺穿，以形成用于药剂的敞开流体路径。进一步按压按钮将药剂输送到患者体中。
防止针56的近侧端部刺穿储腔隔膜的其它装置可以适于供本实用新型的预填充器械使用。例如，可断开塑料保持器可以用来将储腔保持在安全位置中，该可断开塑料保持器通过接合拇指按钮30而断开。可选择地，如以上描述的那样，储腔与拇指按钮相接合，并且沿轴向运动到一位置，在该位置处，隔膜可以简单地通过转动拇指按钮30而被刺穿。
可弃置器械消除对于近侧端部屏蔽件的需要，因为当弃置时，针的近侧端部包含在器械内。可以适应来自现有技术屏蔽系统的远侧端部屏蔽系统，这些现有技术屏蔽系统包括以上提到的美国专利申请公开文本No.2011/0257603，具有少量修改。
作为例子，根据本实用新型的一个优选实施例，在注射期间将外部屏蔽件26推到套筒28中，触发内部屏蔽件24的释放，并且在器械从患者的组织中退出时，内部屏蔽件24在弹簧52的偏压下，穿过在外部屏蔽件的远侧端部上的开口完全地延伸到锁定位置中。在使用后位置中，内部屏蔽件24延伸超出插管末端，保护已污染的末端，使之免于意外针刺扎，并且提供器械已被使用的指示。
通过将外部屏蔽件向近侧运动而自动地释放内部屏蔽件可以按各种方式完成。为了实现根据本实用新型的一个优选实施例的屏蔽操作，外部屏蔽件26接合在外部套筒28的内表面上的凹槽，以防止在外部 屏蔽件26的初始向近侧运动期间外部屏蔽件相对于屏蔽组件的转动。同时，在毂座上的突起嵌套在形成在内部屏蔽件上的一些凸起内，以防止内部屏蔽件24相对于屏蔽组件的转动。此外，内部和外部屏蔽件24、26构造有锥形表面，这些锥形表面布置成，当外部屏蔽件26在初始位置中在内部屏蔽件24上套叠时，各锥形表面彼此邻接。外部屏蔽件26到外部套筒28中的向近侧运动，在外部屏蔽件跃过在外部套筒上的凹槽之后，使各锥形表面抵靠彼此而滑动，以转动外部屏蔽件26。外部屏蔽件的这种转动释放内部屏蔽件，以在弹簧52的偏压下，向远侧运动到使得内部屏蔽件24覆盖住针的位置。内部屏蔽件可以接合在外部套筒或毂座中的凹口，以将内部屏蔽件锁定在这种使用后状态下。
在这个优选实施例中，外部屏蔽件26具有远侧开口，内部屏蔽件24的远侧端部当它偏置到覆盖针的使用后位置时穿过该远侧开口。外部屏蔽件26在远侧端部上具有锥形形状，并且在使用后位置中，内部屏蔽件24的对应台肩部分配合在外部屏蔽件的这个锥形部分内。
用根据本实用新型的单次使用式器械执行注射大体与用根据现有技术的医用笔执行注射相同。较小的单次使用式器械因为拇指按钮对于在外部屏蔽件上的手指握持部的接近性，可以用一只手更容易地操纵。然而，用于注射的器械的准备过程被显著地简化，因为使用者在进行注射之前无需将笔针连结到笔本体上、也无需在注射之后除去笔针。在固定剂量实施例的情况下，使用者无需设置剂量。
上述实施例与使用注射器或医用笔和笔针的当前医疗注射器械和做法相比，提供了很多优点。因为根据本实用新型的针组件是自足型的，所以器械与要求或者小瓶和注射器、或者医用笔和分立式笔针的当前做法相比，提供另外的方便性。此外，这种概念与笔或注射器相比，供给对于在机构设置(institutional settings)中的患者之间的交叉污染的危险的解决方案，因为单次使用式器械在从患者除去之后，被锁定的插管不会被再次使用，并且提供器械已被使用的指示。因为该器械比典型注射器或医用笔和笔针小得如此之多，所以它可以在单 次使用之后被容易地弃置。上述实施例不应该解释成限制本实用新型，本实用新型在所附的权利要求书中限定。

Claims (15)

1.一种单次使用式注射器械，其特征在于，其包括：
毂座，其承载针，并具有用来接合拇指按钮的近侧沟槽、和用来接合屏蔽组件的远侧表面；
所述屏蔽组件包括内部屏蔽件、外部屏蔽件以及外部套筒，该内部屏蔽件在所述针的径向外部，并且具有接合所述毂座的特征部；该外部屏蔽件在所述内部屏蔽件的径向外部，其用于将所述内部屏蔽件保持在初始位置中并且用于在注射之后将所述内部屏蔽件从所述初始位置释放到覆盖着所述针的第二位置，该外部套筒在所述外部屏蔽件的径向外部；
第一弹簧，其在覆盖所述针的远侧方向上偏压所述内部屏蔽件；
小体积储腔，其包含药剂，适于由所述针刺穿，以提供与针插管的流体连通；以及
拇指按钮，其具有突起部，与在所述毂座上的近侧沟槽接合、并且将所述储腔包围在所述拇指按钮与所述毂座之间，所述拇指按钮在其近侧面上具有柱塞，该柱塞接合所述储腔，以从所述针的远侧端部分配药剂。
2.根据权利要求1所述的单次使用式注射器械，其特征在于，所述储腔是筒仓，该筒仓在一侧上具有塞子，并且在与所述一侧相对的侧上具有隔膜，该塞子适于由所述拇指按钮压缩，该隔膜适于由所述针刺穿。
3.根据权利要求1所述的单次使用式注射器械，其特征在于，还包括用于防止所述针在使用之前将所述储腔隔膜刺穿的装置。
4.根据权利要求1所述的单次使用式注射器械，其特征在于，所述药剂是获准自行注射的单次剂量药剂。
5.根据权利要求1所述的单次使用式注射器械，其特征在于，所述药剂是单次剂量的基础胰岛素、胰升糖素状肽(GLP-1)、白细胞生长因子、骨质疏松药剂、或基于激素的糖尿病治疗剂。
6.根据权利要求1所述的单次使用式注射器械，其特征在于，所述外部套筒包括成形成便于手持的表面。
7.根据权利要求1所述的单次使用式注射器械，其特征在于，所述拇指按钮能够转动以便设置剂量水平。
8.根据权利要求1所述的单次使用式注射器械，其特征在于，所述拇指按钮与所述毂座一体地连结。
9.根据权利要求1所述的单次使用式注射器械，其特征在于，还包括在所述毂座和拇指按钮上的对应部分，当所述拇指按钮在所述拇指按钮相对于所述毂座的最远侧位置处或靠近该最远侧位置时，这些对应部分相匹配，其中，在所述毂座和所述拇指按钮上的对应部分的匹配防止所述拇指按钮向近侧、向远侧及/或转动运动。
10.根据权利要求1所述的单次使用式注射器械，其特征在于，其包括第二弹簧，该第二弹簧定位在所述毂座与预填充的所述储腔之间，在远离储腔的方向上偏压所述针，并且防止在使用之前所述针将储腔隔膜刺穿。
11.根据权利要求1所述的单次使用式注射器械，其特征在于，所述拇指按钮能够从安全位置转动到注射位置，在该注射装置中，能够通过按压所述拇指按钮而执行注射。
12.根据权利要求1所述的单次使用式注射器械，其特征在于，所述储腔能够从防止在使用之前所述针将所述储腔隔膜刺穿的位置转动到注射位置，在该注射装置中，能够通过按压所述拇指按钮而执行注射。
13.根据权利要求1所述的单次使用式注射器械，其特征在于，可断开部件将所述针保持在第一位置中，防止在使用之前所述针将储腔隔膜刺穿。
14.根据权利要求1所述的单次使用式注射器械，其特征在于，所述外部屏蔽件能够从初始位置转动到第二位置，在该初始位置中，所述内部屏蔽件被保持；在该第二位置中，所述内部屏蔽件能够在所述第一弹簧的偏压下自由地向远侧运动，以覆盖所述针。
15.根据权利要求1所述的单次使用式注射器械，其特征在于，所述器械从所述拇指按钮的近侧端部到所述外部屏蔽件的远侧端部的长度是60mm或更小，容纳标准的4mm、5mm或8mm注射深度针。
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