CN1292807C - 用于注射装置的驱动机构 - Google Patents

用于注射装置的驱动机构 Download PDF

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CN1292807C
CN1292807C CNB018211666A CN01821166A CN1292807C CN 1292807 C CN1292807 C CN 1292807C CN B018211666 A CNB018211666 A CN B018211666A CN 01821166 A CN01821166 A CN 01821166A CN 1292807 C CN1292807 C CN 1292807C
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geared system
housing
driving mechanism
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syringe
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克里斯托弗·N·兰利
沙恩·A·戴
罗伯特·F·维齐
罗伯特·伍斯顿
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Sanofi Aventis Deutschland GmbH
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    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES 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
    • A61M5/00Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
    • A61M5/14Infusion devices, e.g. infusing by gravity; Blood infusion; Accessories therefor
    • A61M5/142Pressure infusion, e.g. using pumps
    • A61M5/14244Pressure infusion, e.g. using pumps adapted to be carried by the patient, e.g. portable on the body
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES 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
    • A61M5/00Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
    • A61M5/178Syringes
    • A61M5/24Ampoule syringes, i.e. syringes with needle for use in combination with replaceable ampoules or carpules, e.g. automatic
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES 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
    • A61M5/00Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
    • A61M5/14Infusion devices, e.g. infusing by gravity; Blood infusion; Accessories therefor
    • A61M5/142Pressure infusion, e.g. using pumps
    • A61M5/145Pressure infusion, e.g. using pumps using pressurised reservoirs, e.g. pressurised by means of pistons
    • A61M5/1452Pressure infusion, e.g. using pumps using pressurised reservoirs, e.g. pressurised by means of pistons pressurised by means of pistons
    • A61M5/14566Pressure infusion, e.g. using pumps using pressurised reservoirs, e.g. pressurised by means of pistons pressurised by means of pistons with a replaceable reservoir for receiving a piston rod of the pump
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES 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
    • A61M5/00Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
    • A61M5/178Syringes
    • A61M5/20Automatic syringes, e.g. with automatically actuated piston rod, with automatic needle injection, filling automatically
    • GPHYSICS
    • G16INFORMATION AND COMMUNICATION TECHNOLOGY [ICT] SPECIALLY ADAPTED FOR SPECIFIC APPLICATION FIELDS
    • G16HHEALTHCARE INFORMATICS, i.e. INFORMATION AND COMMUNICATION TECHNOLOGY [ICT] SPECIALLY ADAPTED FOR THE HANDLING OR PROCESSING OF MEDICAL OR HEALTHCARE DATA
    • G16H20/00ICT specially adapted for therapies or health-improving plans, e.g. for handling prescriptions, for steering therapy or for monitoring patient compliance
    • G16H20/10ICT specially adapted for therapies or health-improving plans, e.g. for handling prescriptions, for steering therapy or for monitoring patient compliance relating to drugs or medications, e.g. for ensuring correct administration to patients
    • G16H20/17ICT specially adapted for therapies or health-improving plans, e.g. for handling prescriptions, for steering therapy or for monitoring patient compliance relating to drugs or medications, e.g. for ensuring correct administration to patients delivered via infusion or injection
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES 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
    • A61M5/00Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
    • A61M5/178Syringes
    • A61M5/31Details
    • A61M5/315Pistons; Piston-rods; Guiding, blocking or restricting the movement of the rod or piston; Appliances on the rod for facilitating dosing ; Dosing mechanisms
    • A61M5/31565Administration mechanisms, i.e. constructional features, modes of administering a dose
    • A61M5/31576Constructional features or modes of drive mechanisms for piston rods
    • A61M2005/31588Constructional features or modes of drive mechanisms for piston rods electrically driven
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES 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
    • A61M2205/00General characteristics of the apparatus
    • A61M2205/21General characteristics of the apparatus insensitive to tilting or inclination, e.g. spill-over prevention
    • A61M2205/215Tilt detection, e.g. for warning or shut-off
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES 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
    • A61M2205/00General characteristics of the apparatus
    • A61M2205/50General characteristics of the apparatus with microprocessors or computers
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES 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
    • A61M2205/00General characteristics of the apparatus
    • A61M2205/60General characteristics of the apparatus with identification means
    • A61M2205/6018General characteristics of the apparatus with identification means providing set-up signals for the apparatus configuration
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES 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
    • A61M2205/00General characteristics of the apparatus
    • A61M2205/82Internal energy supply devices
    • A61M2205/8206Internal energy supply devices battery-operated
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES 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
    • A61M5/00Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
    • A61M5/178Syringes
    • A61M5/31Details
    • A61M5/315Pistons; Piston-rods; Guiding, blocking or restricting the movement of the rod or piston; Appliances on the rod for facilitating dosing ; Dosing mechanisms
    • A61M5/31525Dosing
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES 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
    • A61M5/00Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
    • A61M5/178Syringes
    • A61M5/31Details
    • A61M5/315Pistons; Piston-rods; Guiding, blocking or restricting the movement of the rod or piston; Appliances on the rod for facilitating dosing ; Dosing mechanisms
    • A61M5/31533Dosing mechanisms, i.e. setting a dose
    • A61M5/31545Setting modes for dosing
    • A61M5/31546Electrically operated dose setting, e.g. input via touch screen or plus/minus buttons
    • YGENERAL TAGGING OF NEW TECHNOLOGICAL DEVELOPMENTS; GENERAL TAGGING OF CROSS-SECTIONAL TECHNOLOGIES SPANNING OVER SEVERAL SECTIONS OF THE IPC; TECHNICAL SUBJECTS COVERED BY FORMER USPC CROSS-REFERENCE ART COLLECTIONS [XRACs] AND DIGESTS
    • Y10TECHNICAL SUBJECTS COVERED BY FORMER USPC
    • Y10STECHNICAL SUBJECTS COVERED BY FORMER USPC CROSS-REFERENCE ART COLLECTIONS [XRACs] AND DIGESTS
    • Y10S128/00Surgery
    • Y10S128/01Motorized syringe

Abstract

本发明公开了一种用于注射装置的驱动机构,其中,活塞装置可选择地驱动,以便从药筒内排出药剂。该驱动机构包括:驱动装置(270);第一齿轮装置(278),该第一齿轮装置与驱动装置相连;第二齿轮装置(274),该第二齿轮装置可在第一位置和第二位置之间运动,在该第一位置,该第二齿轮装置只能沿它的纵向轴线运动,而在该第二位置,第二齿轮装置(274)绕纵向轴线自由旋转,活塞装置与第二齿轮装置(274)相连;壳体(276),第一齿轮装置(278)和第二齿轮装置(274)限制在该壳体内运动;以及偏压装置(282),该偏压装置位于壳体(276)和第二齿轮装置(274)之间,以便将该第二齿轮装置(274)压向第一位置。

Description

用于注射装置的驱动机构
本发明涉及对注射装置的改进,尤其是涉及对用于分配受控量的药剂的注射装置的改进。
通常,这样的注射装置由患有糖尿病的人使用,以便给自己用一定剂量的胰岛素或胰岛素类型的药。还应当知道,这样的注射装置也适于注射其它药剂。
以前,该药剂通过使用一次性针筒来进行给药,该针筒首先从单独的药瓶或其它容器中装满药剂,然后用于注射该药剂。不过,这样的装置中有多个问题。特别是,该装置不适于体弱者。另外,由于这些针筒的社会名声而使它们的公众使用有问题。
为了克服这些困难,开发了多种所谓的钢笔型注射器。这些装置较小,能够装入上衣兜等类似部位,且首先从容纳于该注射器内的药筒或安瓿中获得多个剂量。本发明特别用于这样的钢笔型注射器。尽管这样的钢笔型注射器与一次性皮下注射针筒相比进行了较大改进,但是仍然有一些问题。
特别是,当考虑到钢笔型注射器的驱动系统的设计时,有时会有很多相互冲突的技术要求。该驱动系统必须准确可靠,同时紧凑和高效。该驱动系统必须可靠和坚固,能够在产品的整个使用寿命中起作用。该驱动系统还必须有内在的防故障性。
本发明的优点是它消除或至少基本减小了该问题。本发明用于提高使用的方便性,并改进与用户的相互作用。
下面将仅仅通过举例方式并参考附图来介绍本发明,附图中:
图1表示了本发明的钢笔型注射器的平面图;
图2表示了与图1类似的视图,其中省略了注射器的端帽;
图3表示了图1和2的注射器的剖视图;以及
图4至6表示了还一驱动机构部分通过三个操作阶段时的平面图。
下面参考图1至3,图中可以看到本发明的钢笔型注射器2,该注射器2包括主壳体4,端帽或盖体6可拆卸地安装在该主壳体4上。
在主壳体4的第一端处提供有控制面板区域8。该区域包括:显示面板10,通常为LCD显示器;以及第一剂量按钮12和第二剂量按钮14,该第一和第二剂量按钮可以进行操作,以便增加或减小将释放的药剂的剂量。在所示实施例中的控制面板区域10还包括供给按钮16。
在主壳体的第一端还提供有分配按钮18,优选是,当未压低时,该分配按钮18与主壳体4平齐。
沿注射器2的纵向轴线,控制面板区域10的每一侧都提供有多个槽或凹口20。这帮助用户握住该注射器2。
在主壳体4的第二端,针单元22可释放地安装在主壳体上。主壳体4的第二端还提供有成形(shaped)部分24。
在使用时,药筒40或药剂安瓿装在壳体4中,并在该成形部分24后面。优选是,成形部分为透明,以便使用户能够看见药筒40。
起动按钮26也布置在壳体4的第二端。应当知道,当端帽6布置在壳体的第二端上时,将不会由于疏忽而压低起动按钮26或被针单元22刺伤。在主壳体4的第二端也可以包括盖体检测开关28,以便检测端帽或盖体6是否布置就位。
在图3中,还可以看见与各按钮相对应的起动触点30、供给触点32、第一剂量触点34和第二剂量触点36。还表示了与分配按钮18相对应的分配触点19。
参考图3,可以看见,还提供了用于电源38例如电池的合适位置。还有布置药筒40或药剂安瓿的合适区域。该区域可经过主壳体4的可拆卸成形部分24而接近,以便使用户能够根据需要来更换药筒40或安瓿。
在主壳体4的第三区域还提供有驱动机构42,该驱动机构42通过电源38操作,并作用在药筒40或药剂安瓿上。
药筒40或安瓿包括容器44或套筒,该容器44或套筒的一端由在它头端的盖体46封闭,在另一端由活动塞头48或塞子密封。当就位时,针单元22刺穿盖体46,塞子48朝着盖体46的运动将使得装于药筒40或安瓿内的药剂排出。根据ISO/FDIS 11608 Part 3,该药筒可以是3ml的药筒,或者是其它任何适于该注射器的药筒。
塞子48或塞头的运动由活塞或柱塞50引起,该活塞或柱塞50形成驱动机构42的一部分。该活塞或柱塞50可在第一完全退回位置(未示出)和第二完全伸出位置之间运动,该第一完全退回位置允许更换药筒40或安瓿,而在该第二完全伸出位置,药剂尽可能地从药筒40或安瓿中排出。在主壳体4上可以提供有端部止动开关52,以便检测活塞50在什么时候处于完全退回位置。端部止动开关52的松开可以释放卡子或其它固定装置,以便能进入主壳体4来更换药筒40。
在电子控制单元(未示出)的控制下可通过马达54操作驱动机构42。马达54应当可反转,以便使活塞50能够在第一和第二位置之间运动。在图3中,可以看见马达54通过齿轮组42驱动活塞50,这样,第三转子58的旋转使得活塞50随第三转子58运动。
优选是,在操作时,用户可以感觉到马达54和相应驱动机构42的振动和/或听到它们。这样,增加用户对注射器2的操作的相信程度。
下面将特别参考图1、2和3介绍本发明的钢笔型注射器的功能。
注射器2有电子控制单元。该电子控制单元与驱动机构和用户界面都相连。用户界面包括显示面板10以及用户可操作的按钮(以及相应触点)。该电子控制单元基于微处理器。易失性或永久性存储器可以用于储存“剂量历史”和病人的专门信息。
电子控制单元优选是由注射器电源38供电。
注射器2优选是还包括用于在电子控制单元和外部装置例如个人计算机之间进行连通的口。
注射器2还有起动检测装置(例如倾斜开关或加速计),以便当注射器2翻转时进行识别。通过检测翻转位置(针向上),注射器2将自动改变状态,以便准备起动。起动可以通过按压起动按钮26而开始,以便进行固定小剂量的分配动作。当按下起动按钮26时,电子控制单元可以使喇叭发出声音。
起动按钮26在其它时间都不驱动。当驱动起动按钮时,在控制面板区域的所有其它按钮都失效,这些按钮是用于设置或分配剂量的按钮。
当供给按钮16按下足够时间时,电子控制单元可以使喇叭发出声音,以便向用户提供声音反馈。
供给按钮16的功能是使分配按钮18起动。优选是,在注射器2开始供给时,该供给按钮16保持按下预定时间。供给状态可以在显示面板10上另外表示。优选是,供给按钮的功能与盖体检测开关28相连,这样,该供给按钮16只有在没有盖体6时才起到使注射器2进行供给的功能。
另外,在优选实施例中,电子控制单元内的时钟将检测在注射器2进行供给后的给定时间间隔内是否压低分配按钮18。当在该给定时间间隔内没有压低分配按钮18时,电子控制单元将使注射器2无效。也可选择,当用户在预定时间内第二次按下供给按钮时,该注射器将无效。
在可选实施例中,分配按钮18可以起到起动按钮和剂量按钮的功能。当启动起动检测器时,通过使注射器2定向成针朝上,分配按钮18的功能将变成前述实施例的起动按钮的功能。
优选是,注射器2的按钮有触觉特性,以便向用户提供感觉反馈。
显示面板10通常为LCD显示器,并将提供关于装置操作的文字信息和图形信息。
由于使用了机电驱动,分配动作通过用户操作开关而起动。这意味着操作分配按钮所需的力优化成使用户舒服和符合人机工程要求。
在图4、5和6中表示了成单分度齿轮装置形式的驱动机构。所示的推拉螺线管270有输出轴272。该输出轴与驱动齿轮278相连。驱动齿轮278在齿轮壳体276内被纵向驱动。丝杠的轴280与从动齿轮274相连。应当知道,丝杠包括用于使塞子48在药筒40(本说明书中所述)中前进的活塞。从动齿轮布置成在齿轮壳体276内纵向运动。弹簧偏压装置(通常为螺旋弹簧282)布置在从动齿轮274的后面和齿轮壳体276之间,以便将从动齿轮274压向驱动齿轮278。从动齿轮274和驱动齿轮278分别有角度分布的齿,这样,从动齿轮274的齿可以与驱动齿轮278的齿啮合。
从动齿轮274通过在它的外径上有键槽(未示出)而帮助旋转,该键槽将与在壳体276的内表面上的一组花键(未示出)啮合。该花键防止从动齿轮274完全与驱动齿轮278啮合。当驱动齿轮通过螺线管270的推动冲程而前进时,从动齿轮274沿花键推向弹簧偏压装置282,直到它到达可以使该从动齿轮274与花键脱开的点。在该点处,从动齿轮274在弹簧偏压装置的推力和螺线管的推力的组合作用下而旋转,直到从动齿轮274和驱动齿轮278的齿啮合(图5)。
在返回冲程中,从动齿轮274在弹簧偏压装置282的作用下返回。不过,由于旋转,这时键槽获得下一个花键位置,从而使从动齿轮274返回到与起始位置相同的纵向位置,但是角度位置偏离在前起始位置。
该驱动机构有多个优点。尤其是,它没有可能导致驱动机构堵塞的不确定位置。还有,驱动机构锁定在各冲程的端头,从而不可能进行偶然分配。

Claims (4)

1.一种用于注射装置的驱动机构,其中,活塞装置可选择地受到驱动,以便从药筒内排出药剂,该驱动机构包括:驱动装置(270);第一齿轮装置(278),该第一齿轮装置与驱动装置相连;第二齿轮装置(274),该第二齿轮装置可在第一位置和第二位置之间运动,在该第一位置,该第二齿轮装置(274)只能沿它的纵向轴线运动,而在该第二位置,第二齿轮装置(274)绕纵向轴线自由旋转,活塞装置与第二齿轮装置(274)相连;壳体(276),第一齿轮装置(278)和第二齿轮装置(274)限制在该壳体内运动;以及偏压装置(282),该偏压装置位于壳体(276)和第二齿轮装置(274)之间,以便将该第二齿轮装置(274)压向第一位置;
其中:第二齿轮装置(274)和壳体(276)中的一个设有多个花键,而第二齿轮装置(274)和壳体(276)中的另一个设有键槽,当第二齿轮装置(274)处于第一位置时,该花键位于该键槽内;
驱动装置(270)的第一运动使得第一齿轮装置(278)从初始位置向第二齿轮装置(274)前进,从而使第二齿轮装置(274)从第一位置运动到第二位置;驱动装置(270)的第二运动使得第一齿轮装置(278)返回初始位置,第二齿轮装置(274)在返回时键槽获得下一花键的位置,从而使第二齿轮装置(274)能够旋转,并在偏压装置(282)的作用下返回第一位置。
2.根据权利要求1所述的驱动机构,其特征在于:该驱动装置(270)包括推拉螺线管。
3.根据权利要求1或2所述的驱动机构,其特征在于:该偏压装置(282)包括螺旋弹簧。
4.根据权利要求1或2所述的驱动机构,其特征在于:该活塞装置包括丝杠。
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IL156238A (en) 2009-02-11
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IL156245A (en) 2007-12-03
KR100826220B1 (ko) 2008-04-30
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BR0116277A (pt) 2003-12-30
DE60112472T2 (de) 2006-08-17
BR0116296B1 (pt) 2009-12-01
ES2240341T3 (es) 2005-10-16
BR0116278B1 (pt) 2010-09-21
CN1290589C (zh) 2006-12-20
PT1353715E (pt) 2005-08-31
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EP1353715B1 (en) 2005-05-04

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