CN101227942B - 具有剂量限制机构和另外的安全机构的注射器设备 - Google Patents

具有剂量限制机构和另外的安全机构的注射器设备 Download PDF

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CN101227942B
CN101227942B CN2006800271153A CN200680027115A CN101227942B CN 101227942 B CN101227942 B CN 101227942B CN 2006800271153 A CN2006800271153 A CN 2006800271153A CN 200680027115 A CN200680027115 A CN 200680027115A CN 101227942 B CN101227942 B CN 101227942B
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J·埃兰德
C·P·恩加尔德
C·S·莫勒
T·H·马库森
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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
    • A61M5/178Syringes
    • 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
    • A61M5/31583Constructional features or modes of drive mechanisms for piston rods based on rotational translation, i.e. movement of piston rod is caused by relative rotation between the user activated actuator and the piston rod
    • AHUMAN NECESSITIES
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    • 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
    • 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
    • A61M5/31548Mechanically operated dose setting member
    • A61M5/3155Mechanically operated dose setting member by rotational movement of dose setting member, e.g. during setting or filling of a syringe
    • A61M5/31553Mechanically operated dose setting member by rotational movement of dose setting member, e.g. during setting or filling of a syringe without axial movement of dose setting member
    • 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
    • A61M5/31535Means improving security or handling thereof, e.g. blocking means, means preventing insufficient dosing, means allowing correction of overset dose
    • A61M5/31541Means preventing setting of a dose beyond the amount remaining in the cartridge
    • 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
    • A61M5/31548Mechanically operated dose setting member
    • A61M5/31556Accuracy improving means
    • A61M5/31558Accuracy improving means using scaling up or down transmissions, e.g. gearbox
    • 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
    • A61M5/31548Mechanically operated dose setting member
    • A61M5/31561Mechanically operated dose setting member using freely adjustable volume steps
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
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    • 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
    • A61M5/31566Means improving security or handling thereof
    • A61M5/31573Accuracy improving means
    • 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
    • A61M5/3159Dose expelling manners
    • A61M5/31593Multi-dose, i.e. individually set dose repeatedly administered from the same medicament reservoir

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Abstract

一种用于排出一定剂量的药品的注射器设备,该注射器设备包括:剂量限制机构,其布置为与剂量排出机构相互作用,以防止排出超过设定剂量的剂量;和安全机构,其相对于剂量排出机构布置为使得如果剂量限制机构失效,则安全机构防止排出超过设定剂量的剂量。

Description

具有剂量限制机构和另外的安全机构的注射器设备
技术领域
本发明涉及包括用于防止排出超过设定剂量的剂量的机构的注射器设备。特别地,本发明涉及包括用于防止排出超过设定剂量的剂量的两个独立的机构的注射器设备。
背景技术
当药物注射到人体内时,如果注射的剂量超过设定剂量,则可能具有严重的或甚至致命的结果。因此,重要的是,注射器设备包括用于限制排出到设定剂量的装置。
本发明的目的是提供包括用于防止排出超过设定剂量的剂量的装置的注射器设备。而且,因为这样的装置可能失效,本发明的目的是提供包括安全机构的注射器设备,该安全机构适合于如果用于防止的装置失效则防止排出超过设定剂量的剂量。
发明内容
本发明涉及用于排出一定剂量的药品的注射器设备,该注射器设备包括:
-壳体,
-剂量排出机构,其包括:
-相对于壳体可旋转的剂量设定构件,以设定要排出的剂量,
-活塞杆,其相对于壳体布置为使得活塞杆在远端方向上的平移导致该剂量被排出,
-用于将剂量设定构件的平移转化为活塞杆的平移的装置,
-剂量限制机构,其布置为与剂量排出机构相互作用,以防止排出超过设定剂量的剂量,和
-安全机构,其相对于剂量排出机构布置为使得如果剂量限制机构失效,则安全机构防止排出超过设定剂量的剂量。
本发明的优点在于,如果剂量限制机构未能限制排出的剂量,则触发安全机构,且因此提供对于病人的额外安全性。
在一个实施例中,剂量限制机构和安全机构是彼此独立工作的两个独立的机构。
在一个实施例中,两个机构适合于同时防止排出超过设定剂量的剂量。在另一个实施例中,安全机构仅如果剂量限制机构未能防止排出超过设定剂量的剂量时被触发。在一个实施例中,两个机构布置为使得如果剂量限制机构失效,安全机构即刻被触发,使得排出的剂量不超过设定剂量。在另一个实施例中,如果剂量限制机构失效且安全机构被触发,则排出的剂量无关紧要地大于设定剂量。无关紧要地大于意味着剂量的改变太小而没有严重或者致命的结果。
壳体可以限定用于活塞杆的通道,通道具有带螺纹的内表面,以与活塞杆的带螺纹的外表面接合,活塞杆相对于壳体布置为使得活塞杆相对于壳体的旋转导致活塞杆相对于壳体平移位移。
在一个实施例中,剂量限制机构和安全机构中的至少一个适合于将活塞杆和壳体之间的相对旋转移动限制到对应于设定剂量的排出的旋转。当活塞杆包括适合于接合壳体的带螺纹的内表面的带螺纹的外表面时,就是这样的情况。因此,活塞杆(相对于壳体)的旋转锁定导致活塞杆相对于壳体的平移锁定。
剂量限制机构可以包括至少一个第一停止表面,其适合于接合壳体的至少一个相应的第二停止表面。而且,剂量设定构件在剂量设定期间的旋转可以导致第一停止表面从第二停止表面移开,且在排出剂量期间的旋转可以导致第一停止表面和第二停止表面相向移动。而且,当第一停止表面邻接第二停止表面时,防止排出剂量。剂量设定构件可以包括该至少一个第一停止表面。替代地或作为补充,剂量设定构件可以联接到包括第一停止表面的圆筒,且所述圆筒适合于指示设定剂量。第一停止表面和第二停止表面可以为大致平面表面,其可以在平行于注射器设备的轴向方向的方向上延伸。替代地,停止表面可以在横向于轴向方向的平面,诸如正交于轴向方向的平面中延伸。
在一个实施例中,安全机构包括:限定了用于活塞杆的通道的限制器,限制器的通道限定带螺纹的内表面以与活塞杆的带螺纹的外表面接合,和限定了用于限制器的通道的驱动件,驱动件旋转地相对于限制器保持,驱动件联接到剂量设定构件,使得剂量设定构件在剂量设定期间的旋转导致驱动件旋转,其中在剂量设定期间驱动件和活塞杆之间的相对旋转导致限制器离开停止位置移动,其中,限制器防止排出剂量。
在一个实施例中,注射器设备适合于防止设定超过注射设备的存储器内的药品量的剂量。在这样的实施例中,活塞杆包括剂量终止停止表面,其适合于当设定剂量对应于设备的存储器内的药品的量时接合限制器的对应表面。因此,在这样的实施例中,限制器用作两种功能,第一功能为防止设定超过存储器内留下的药品量的剂量,且第二功能为安全功能,适合于防止排出超过设定剂量的剂量。
而且,注射器设备可以包括排出辅助系统,以提供排出力用于辅助设备的操作者在所述远端方向推动活塞,使得排出设定剂量。当使用者开始排出时,排出辅助系统适合于在没有使用者的帮助下在远端方向上推动活塞,以排出剂量。
排出辅助系统可以包括弹簧,诸如扭转弹簧,其布置为相对于壳体旋转驱动件。当限制器处于停止位置时,弹簧可以预先应变。特别地,当弹簧预先应变时,本发明的冗余的安全系统是有利的,因为预先应变的弹簧的意外去除应变可能导致活塞杆旋转(且因此平移)相应于致命的剂量,诸如100IU的胰岛素。
附图说明
现在将参考图1进一步详细描述本发明,图1披露了根据本发明的注射器设备。
具体实施方式
图1示出了注射器设备2,注射器设备包括壳体4和活塞杆6。注射器设备2还包括剂量设定构件8和驱动件10,它们在图中结合为一个单一的单元。注射器设备进一步包括刻度筒12,以通过窗14指示设定剂量。刻度筒12具有带螺纹的外表面15,外表面15适合于接合壳体的相应的带螺纹的内表面16。刻度筒12通过沟槽-舌部接合18相对于驱动件10可旋转地保持。刻度筒12包括第一停止表面17,第一停止表面17适合于接合壳体的第二停止表面19。第一停止表面17和第二停止表面19组成了剂量限制机构21。第一停止表面在剂量设定期间从第二停止表面19移开,且在排出剂量期间二者相向移动。当两个表面相互邻接时,防止设备排出药品。
注射器设备包括具有在驱动件10和壳体的近端部分20之间延伸的预先应变的扭转弹簧23形式的排出辅助系统。因此,当剂量设定构件8被旋转以设定剂量时,弹簧进一步应变。
活塞杆6包括带螺纹的外表面22,外表面22适合于接合壳体24的相应的带螺纹的内表面,且因此活塞杆相对于壳体的旋转导致活塞杆相对于壳体平移。活塞杆的带螺纹的外表面22也接合限制器28的带螺纹的内表面26,限制器在图1中定位在停止位置,其中限制器的底表面30接合活塞杆导向件34的上表面32。底表面30和上表面32形成了安全机构31。气隙可以提供在底表面30和上表面32之间,这在剂量注射期间如果剂量限制机构21失效,则允许限制器和活塞杆旋转对应于注射的剂量的无关紧要的增加,例如3IU的胰岛素的角度。
此外,限制器28的上容量终止表面36适合于接合活塞杆的T形端部部分40的下容量终止表面38。容量终止表面适合于当设定剂量对应于设备的存储器(未示出)内剩余的药品量时接合。因此,容量终止表面的接合防止了设定超过存储器内剩余的药品量的剂量。将认识到的是,容量终止表面之间的距离因此对应于存储器内剩余的药品量。
此外,筒12的上表面11可以适合于当设定最大剂量时接合壳体的下表面13。最大剂量是可以为每个排出(假定注射器设备包括要求的药品量)设定的最大剂量。最大剂量不对应于涉及设备内的剩余药品量的容量终止剂量。因此,只要设备内剩余的药品量大于最大剂量,则容量终止表面在剂量设定期间不相互邻接,而当设备内剩余的药品量低于最大剂量时,最大剂量表面不会在剂量设定期间相互邻接,因为容量终止表面防止了进一步的旋转。
限制器28和驱动件10通过沟槽-舌部接合42锁定相对旋转。因此,当活塞杆相对于壳体锁定旋转时,驱动件8和活塞杆6之间的相对旋转导致限制器从停止位置移开且向T形端部部分40移动(即在图中向上移动)。当活塞杆导向件34相对于壳体(未示出)锁定旋转时,活塞杆相对于壳体锁定旋转,因为活塞杆导向件34和活塞杆由于沟槽-舌部接合44而锁定相对旋转。
驱动件12和活塞杆导向件34通过双向棘齿机构46相互连接,棘齿机构46包括至少一个由驱动件12限定的第一保持构件48和至少一个由活塞杆导向件34限定的第二保持构件50。双向棘齿机构适合于在剂量设定期间允许驱动件12和活塞杆导向件34之间的相对旋转移动,且保证在剂量排出期间驱动件的旋转移动传递到活塞杆导向件34。
设备的使用如下。最初,活塞杆导向件相对于壳体锁定旋转。然后,使剂量设定构件旋转,这导致驱动件和刻度筒旋转且预先应变的弹簧更进一步应变。同时,限制器向T形端部部分移动。如果使用者试图设定超过设备内药品量的剂量,则限制器邻接T形端部部分,以此不能设定更大的剂量。通过移除活塞杆导向件34和壳体之间的旋转锁定排出剂量,以此应变的弹簧促使驱动件旋转。旋转的驱动件促使活塞杆导向件旋转,这又促使活塞杆旋转。由于沟槽-舌部接合44和活塞杆和壳体之间的螺纹相互连接,促使旋转的活塞杆向前移动且因此从设备排出药品。

Claims (10)

1.一种用于排出一定剂量的药品的注射器设备,该注射器设备包括:
-壳体;
-剂量排出机构,其包括:
-相对于壳体可旋转的剂量设定构件,以设定要排出的剂量,
-活塞杆,其相对于壳体布置为使得活塞杆沿远端方向的平移导致该剂量被排出,
-用于将剂量设定构件的旋转转化为活塞杆的平移的装置;
-剂量限制机构,其布置为与剂量排出机构相互作用,以防止排出超过设定剂量的剂量;和
-安全机构,其相对于剂量排出机构布置为使得如果剂量限制机构失效,则安全机构防止排出超过设定剂量的剂量。
2.根据权利要求1所述的注射器设备,其中,壳体限定用于活塞杆的通道,该通道具有带螺纹的内表面,以与活塞杆的带螺纹的外表面接合,活塞杆相对于壳体布置为使得活塞杆相对于壳体的旋转导致活塞杆相对于壳体平移移位。
3.根据权利要求1或2的任何项所述的注射器设备,其中,剂量限制机构和安全机构中的至少一个适合于将活塞杆和壳体之间的相对旋转移动限制到对应于设定剂量的排出的旋转。
4.根据权利要求1或2所述的注射器设备,其中,剂量限制机构包括第一停止表面,其适合于接合壳体的相应的第二停止表面,以及其中,剂量设定构件在剂量设定期间的旋转导致第一停止表面从第二停止表面移开,且其中,当第一停止表面邻接第二停止表面时,防止排出剂量。
5.根据权利要求4所述的注射器设备,其中剂量设定构件包括该第一停止表面。
6.根据权利要求4所述的注射器设备,其中剂量设定构件联接到包括该第一停止表面的圆筒,所述圆筒适合于指示设定剂量。
7.根据权利要求1-2或5-6的任何项所述的注射器设备,其中,安全机构包括:
限定了用于活塞杆的通道的限制器,限制器的通道限定带螺纹的内表面以与活塞杆的带螺纹的外表面接合,和
限定了用于限制器的通道的驱动件,驱动件旋转地相对于限制器保持,驱动件联接到剂量设定构件,使得剂量设定构件在剂量设定期间的旋转导致驱动件旋转;
其中,在剂量设定期间驱动件和活塞杆之间的相对旋转导致限制器离开停止位置移动,其中,限制器防止排出剂量。
8.根据权利要求7所述的注射器设备,进一步包括排出辅助系统,以提供排出力用于辅助设备的操作者沿所述远端方向推动活塞,使得排出设定剂量。
9.根据权利要求8所述的注射器设备,其中排出辅助系统包括弹簧,其布置为相对于壳体旋转驱动件。
10.根据权利要求9所述的注射器设备,其中,当限制器处于停止位置时,弹簧被预紧。
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