CN112041009A - 用于可伸缩针头注射器的安全和填充系统 - Google Patents

用于可伸缩针头注射器的安全和填充系统 Download PDF

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CN112041009A
CN112041009A CN201980028208.5A CN201980028208A CN112041009A CN 112041009 A CN112041009 A CN 112041009A CN 201980028208 A CN201980028208 A CN 201980028208A CN 112041009 A CN112041009 A CN 112041009A
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piston
safety
retractable needle
filling system
piercing head
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C·R·卡蒂埃
G·普罗菲蒂
R·瓦莱斯
P·毛罗
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P & P Patent & Technology Co ltd
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    • 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
    • A61M5/31—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
    • A61M5/3205—Apparatus for removing or disposing of used needles or syringes, e.g. containers; Means for protection against accidental injuries from used 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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    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
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    • 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
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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
    • A61M5/31565—Administration mechanisms, i.e. constructional features, modes of administering a dose
    • A61M5/3159—Dose expelling manners
    • A61M5/31593—Multi-dose, i.e. individually set dose repeatedly administered from the same medicament reservoir
    • A61M5/31595—Pre-defined multi-dose administration by repeated overcoming of means blocking the free advancing movement of piston rod, e.g. by tearing or de-blocking
    • 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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    • 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
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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
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    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
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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
    • A61M5/5013—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
    • A61M2005/5026—Means for blocking the piston or the fluid passageway to prevent illegal refilling of a syringe for blocking the piston allowing single filling of syringe
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    • A61M2205/27—General characteristics of the apparatus preventing use
    • A61M2205/273—General characteristics of the apparatus preventing use preventing reuse, e.g. of disposables

Abstract

本发明涉及一种创新系统，该系统切实地防止了带有可伸缩针头的注射器的重复使用，同时允许借助于安装在活塞内的机械系统来填充储箱。旨在防止装置再次使用的操作是通过机械系统进行的，该机械系统防止活塞向着抽吸的初始位置返回并因此将其活动限制在单个方向上，并且防止活塞返回到注射的初始位置并因此将其活动限制在单个方向上。此外，旋转机械过渡系统防止活塞重新定位在先前使用的位置。相反，容器的填充是通过使用系统、经由放置于活塞内部的挠性套管进行的。

Description

用于可伸缩针头注射器的安全和填充系统
本发明涉及一种创新系统，该系统切实地防止了带有可伸缩针头的注射器的重复使用，同时允许借助于安装在活塞内部的机械系统来填充储箱。
健康护理专业人员，例如护士、医生、兽医、牙医以及废物处理人员，每天都遭受着已与可能携带可传染的传染病的生物的生物流体直接接触的先前用于医学治疗或其他方面的接种系统造成的意外刺伤的危险。
由先前使用的接种系统所造成的意外刺伤是接触传染病的最常见和最危险的方式。实际上，在意外刺伤后，有40多种可通过血液或生物液体传播的病原体。其中包括：人类免疫缺陷病毒(HIV)、乙型肝炎病毒(HBV)和丙型肝炎病毒(HCV)。从遭受意外刺伤的身体伤害的人们的经济学和心理学的角度来看，与公共和私人卫生系统生物风险管理有关的问题带来了非常高昂且无法维持的成本。
但是，用于以非天然方式引入或提取药用物质的容器必须不仅保证安全性，避免意外刺伤的危险，而且还不能重复使用。
实际上，在注射疫苗或其他药物后，重新使用容器以重新引入药理学物质是一个普遍的习惯，尤其是在经济状况不佳的国家。
在市场上，有不同类型的可伸缩针头注射器，其中一些也获得了特殊专利，其安全系统可以通过不完成容器内的活塞行程而被绕开(这经常发生)，从而允许重复使用装置。
还应强调在疫苗接种活动和抗血栓药物的施用中使用药用物质的容器的情况，其中容器本身被提供到预先装有药物的医疗设施中。
药物的填充是由制药公司进行的，容器在完全未组装的情况下提供给制药公司。此后，制药公司在填充药物后的不同阶段对这些容器进行组装。
这种方法通过显著增加操作员的操作而增加了在许多准备阶段中的污染风险。
尽管已尝试以各种方式限制这些问题，其中一些方式也出现在一些专利中，包括专利EP2445554B1、US3998224A、US4252118A、US4391273A、US4687467A、US5062833A、US5205825A以及RU2236873和WO1998001174A1，但它们不能完全阻止注射器的重复使用，也不能提供不使用针头即可填充注射器的简单而有效的方法。
通过本发明，克服了前述的关键性问题，本发明允许从人体或动物体引入和提取物质，通过实际上不可违反的手段防止装置的重复使用，并且还指定了一种单独的方式来为容器填充即用型药物。
旨在防止装置重复使用的操作是通过机械系统进行的：
a)一旦装置中的药用物质的抽吸动作开始，它就会防止活塞向着抽吸的初始位置返回并因此将其动作限制在单个方向上；
b)一旦在装置中开始药用物质的注射，它就会防止活塞返回到注射的初始位置并因此将其动作限制在单个方向上；同样，置于抽吸操作和注射操作之间的旋转机械过渡系统(由引导活塞的滑块组成)防止活塞重新定位在先前使用的位置。
相反，容器的填充是通过使用系统、经由放置于活塞内部的挠性套管进行的，期望的物质通过该套管被输送，从而被倒入容器内，然后准备被注射。
为了说明的目的，现在将根据本发明的优选实施例尤其是参考图片和附图来描述本发明，而不以任何限制的方式来理解本发明，同时牢记，在不影响其功能的情况下，所使用的所有实施例可以在尺寸、数量和形状上变化，而这并不限制本发明：
图1示出了容器，重点在于从上方观察的、在框中的翅片和棘齿；
图2示出了带有翅片和棘齿的容器的一部分；
图3示出了带有翅片和棘轮的容器的另一视图；
图4示出了活塞上的“U”形通道系统以及齿条系统；
图5示出了活塞上的“U”形通道系统以及齿条系统的另一视图；
图6示出了位于活塞中的腔体；
图7示出了容纳在活塞内部的机械系统；
图8示出了容纳在活塞内部的机械系统的细节；以及
图9示出了容纳在活塞内部的机械系统被压缩时的细节。
参照所示的附图，系统的基本元件是显而易见的，由容器(101)形成。容器(101)在其顶端部配设有齿(102)和两个带凹口的翅片(104和105)。齿(102)以及翅片(104和105)分别允许活塞(106)的滑动和锁定，因此活塞(106)的外表面的特征在于具有“U”形通道系统(107)和双齿条系统(108-103)。
更准确地，在容器(101)内部安置有齿(102)，其使活塞在容器中沿着凹槽状通道(107)滑动。沿齿(102)滑动的凹槽状导向件(107)使活塞(106)能够首先从底部向上移动以允许抽吸药用物质，然后在旋转后从顶部向底部移动以便注射药用物质。
活塞(106)的抽吸和注射运动由于锁定系统而变得不可逆，该锁定系统通过位于容器(101)中的两个带凹口的翅片(104和105)和位于活塞(106)上的两个齿条系统(108和103)的重叠来实现，它们通过彼此相互作用而不允许活塞(106)返回。
这样，一旦装置中的药用物质抽吸动作开始，齿条系统(103)与带凹口的翅片(105)的重叠就防止了活塞(106)向着初始抽吸位置返回，从而使它只沿一个方向滑动。同样，一旦将药用物质注入装置的动作开始，齿条系统(108)与带凹口的翅片(104)的重叠就防止了活塞返回到初始注射位置。
在预填充的可伸缩针头装置的情况下，上述系统还避免了意外释放药用物质。
活塞(106)还具有一个特殊的腔体(117)，在腔体(117)的底部有一互锁壳体(109)，一旦注射阶段结束，该互锁壳体(109)就会钩住针头(114)并使针头(114)从衬垫(110)缩回，该衬垫(110)引导药用物质的抽吸和注射阶段。
在活塞(106)的腔体(117)内部安装有一机械系统，该机械系统的上部由穿孔头(111)组成，该穿孔头(111)允许整个系统被固定在活塞(106)内，其中穿孔头(111)允许将药用物质注射到注射器中，并在其上端具有阀(112)，该阀(112)防止位于容器中的药物向外部回流。
穿孔头(111)连接到由任何生物相容性材料制成的可折叠套管(113)，然后可折叠套管(113)在下部连接到互锁壳体(109)，互锁壳体(109)允许在注射结束时与针头(114)的联接并因此允许针头(114)缩回。
穿孔头(111)和互锁壳体(109)通过弹簧(116)相互连接，该弹簧(116)容纳可折叠套管(113)，并控制在药用物质的接种和抽吸操作期间其如何伸展和收缩。
操作者或专用机器在将活塞(106)插入容器之后，通过位于活塞(106)中的可折叠套管(113)，可以通过穿孔头(111)将药用物质注射到容器中，然后用保护盖(115)关闭活塞(106)。
为了说明性而非限制性的目的，已经关于本发明的功能对其进行了描述，因此，应当理解，也可以在不脱离相关保护范围的情况下，对本发明的形状、大小和尺寸以及构成本发明的部件的布置和材料进行改变和/或修改。

Claims (6)

1.一种用于可伸缩针头注射器的安全和填充系统，其特征在于具有针筒(101)，所述针筒(101)在其内顶端部设有小齿(102)和两个带凹口的翅片(104和105)并且设有活塞(106)，所述活塞(106)的外表面上具有呈“U”形的凹槽系统(107)和双齿条系统(108-103)，而所述活塞(106)的内部配设有腔体(117)，所述腔体(117)在其上部具有穿孔头(111)，阀门(112)位于所述穿孔头(111)上，并且所述腔体(117)的内部安装有机械系统，所述机械系统由互锁壳体(109)、弹簧(116)和可折叠套管(113)组成。
2.根据前述权利要求所述的用于可伸缩针头注射器的安全和填充系统，其中，位于所述活塞(106)外部的所述凹槽状导向件(107)沿位于所述针筒(101)内部的所述齿(102)滑动，使所述活塞(106)首先从底部向顶部移动，然后再从顶部向底部移动。
3.根据前述权利要求所述的用于可伸缩针头注射器的安全和填充系统，其中，所述活塞(106)上的所述齿条系统(103)重叠在位于所述针筒(101)中的所述带凹口的翅片(105)上，从而防止所述活塞(106)向着初始抽吸位置返回。
4.根据前述权利要求所述的用于可伸缩针头注射器的安全和填充系统，其中，所述活塞(106)上的所述齿条系统(108)重叠在位于所述针筒(101)中的所述带凹口的翅片(104)上，从而防止所述活塞(106)向着初始注射位置返回。
5.根据前述权利要求所述的用于可伸缩针头注射器的安全和填充系统，其中，由穿孔头(111)组成的机械系统安装在所述活塞(106)的所述凹部(117)内部，然后由被止挡件(115)覆盖的阀(112)关闭，其中，向所述穿孔头(111)注射药用物质，所述穿孔头(111)连接到可折叠套管(113)，所述可折叠套管(113)在下部连接到所述互锁壳体(109)，所述互锁壳体(109)允许在注射结束时与针头(114)的联接并因此允许所述针头(114)缩回。
6.根据权利要求1和5所述的用于可伸缩针头注射器的安全和填充系统，其中，所述可折叠套管(113)被封闭在弹簧(116)内，所述弹簧(116)连接到所述穿孔头(111)和所述互锁壳体(109)，所述弹簧(116))在药用物质的接种和抽吸过程中伸展或收缩。
CN201980028208.5A 2018-05-22 2019-05-16 用于可伸缩针头注射器的安全和填充系统 Pending CN112041009A (zh)

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