CN101217989A - 注射装置 - Google Patents

注射装置 Download PDF

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CN101217989A
CN101217989A CN200680024971.3A CN200680024971A CN101217989A CN 101217989 A CN101217989 A CN 101217989A CN 200680024971 A CN200680024971 A CN 200680024971A CN 101217989 A CN101217989 A CN 101217989A
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piston rod
slide block
drive sleeve
latch elements
shell
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CN101217989B (zh
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L·U·尼尔森
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Novo Nordisk AS
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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
    • 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
    • A61M5/315—Pistons; Piston-rods; Guiding, blocking or restricting the movement of the rod or piston; Appliances on the rod for facilitating dosing ; Dosing mechanisms
    • A61M5/31533—Dosing mechanisms, i.e. setting a dose
    • A61M5/31545—Setting modes for dosing
    • A61M5/31548—Mechanically operated dose setting member
    • A61M5/3155—Mechanically operated dose setting member by rotational movement of dose setting member, e.g. during setting or filling of a syringe
    • 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
    • A61M5/178—Syringes
    • A61M5/24—Ampoule syringes, i.e. syringes with needle for use in combination with replaceable ampoules or carpules, e.g. automatic
    • 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
    • A61M5/178—Syringes
    • A61M5/31—Details
    • 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
    • A61M5/31576—Constructional features or modes of drive mechanisms for piston rods
    • A61M5/31583—Constructional 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
    • 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
    • A61M5/178—Syringes
    • A61M5/31—Details
    • 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
    • A61M5/31511—Piston or piston-rod constructions, e.g. connection of piston with piston-rod
    • 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
    • A61M5/178—Syringes
    • A61M5/31—Details
    • 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
    • A61M5/31533—Dosing mechanisms, i.e. setting a dose
    • A61M5/31535—Means improving security or handling thereof, e.g. blocking means, means preventing insufficient dosing, means allowing correction of overset dose
    • A61M5/31541—Means preventing setting of a dose beyond the amount remaining in the cartridge
    • 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
    • A61M5/178—Syringes
    • A61M5/31—Details
    • 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
    • A61M5/31533—Dosing mechanisms, i.e. setting a dose
    • A61M5/31545—Setting modes for dosing
    • A61M5/31548—Mechanically operated dose setting member
    • A61M5/3155—Mechanically operated dose setting member by rotational movement of dose setting member, e.g. during setting or filling of a syringe
    • A61M5/31551—Mechanically operated dose setting member by rotational movement of dose setting member, e.g. during setting or filling of a syringe including axial movement of dose setting member
    • 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
    • A61M5/178—Syringes
    • A61M5/31—Details
    • 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
    • A61M5/31576—Constructional features or modes of drive mechanisms for piston rods
    • A61M5/31583—Constructional 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
    • A61M5/31585—Constructional 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 performed by axially moving actuator, e.g. an injection button
    • 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
    • A61M5/178—Syringes
    • A61M5/31—Details
    • 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

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  • Infusion, Injection, And Reservoir Apparatuses (AREA)
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Abstract

一种具有行进离合器的注射装置，该行进离合器可通过注射按钮的驱动在两个不同位置之间切换。在第一位置中，注射按钮和驱动件(70)允许相对于活塞杆(60)旋转，该活塞杆由卡锁元件(80)阻挡而不旋转。在第二位置中，驱动套筒(70)和注射按钮可轴向移动而活塞杆(60)允许旋转。

Description

注射装置
技术领域
本发明涉及用于优选地以皮下方式传送液体药品到人体中的诸如注射笔的设备，并且尤其涉及具有活塞杆的注射装置，该活塞杆具有双螺纹。
背景技术
在本发明的公开中，主要对通过注射胰岛素治疗糖尿病进行参考；但是这仅仅是本发明的示例用途。
注射笔主要为不得不频繁为自己注射的用户而制造，例如患糖尿病的人群。对这样的注射笔设定了许多要求。剂量的设定必须容易而且明确，并且必须易于读取设定的剂量。必须可以以最小的麻烦取消或者改变错误设定的剂量，并且当剂量被注射时剂量设定必须返回零。当预填充的注射笔在考虑中时，即当贮存器变空时被抛弃的注射笔，该注射笔还必须便宜并且由适于再生的材料制成。
大多数剂量设定装置通过带螺纹的活塞杆与螺母协作来工作，其中螺母和活塞杆可以相对于彼此旋转。通过旋拧螺母离开止动件获得剂量设定，在注射期间通过向前按压活塞杆直到螺母元件靠在止动件上而使得螺母返回止动件。通过其他剂量设定装置，这些元件之一(螺母或者活塞杆)被保持不可旋转，并且另一个元件根据设定的剂量被允许转动设定角度，由此活塞杆通过螺母元件向前旋拧一定距离。
满足上述要求的现有技术传送设备在US6,004,297中公开。在其图6至10中描述的实施例中公开的设备包括活塞杆，该活塞具有近端螺纹和远端螺纹。近端螺纹由驱动件接合，而远端螺纹由外壳部分中的螺纹接合，该外壳部分将剂量设定和注射部分与筒握持部分相桥接。
通过在活塞杆的近端螺纹向上旋转驱动件来设定剂量并且通过轴向返回驱动件来注射剂量。为了确保剂量的设定数被实际排出，重要的是驱动件仅仅在轴向上返回，即重要的是防止在注射期间驱动件在近端螺纹向下旋转。
为了确保当注射时驱动件不旋转，在驱动件上设置多个凹槽，这些凹槽由外壳内表面上的一个或多个突起所接合。
在WO04/078239中公开了类似的注射笔。此注射笔也包括具有两个不同螺纹的螺纹活塞杆。此处驱动件通过使用卡锁元件接合离合器以在注射期间轴向锁定驱动件。
发明内容
考虑到上述现有技术装置，本发明的目的是提供一种药品传送装置，其消除了现有技术样品传送装置的缺点并且提供在注射期间对驱动件的改进锁定。
位于活塞杆驱动套筒和注射按钮之间的连接件或者行进离合器被设计为使得当设定剂量时允许驱动套筒和注射按钮相对于活塞杆旋转，该活塞杆由卡锁元件阻止进行旋转。
在注射期间，驱动套筒和注射按钮轴向移动返回同时促使活塞杆旋转。
连接件或离合器包括滑块元件，其固定在外壳中使得滑块仅可以相对于外壳轴向移动。
此外设置有卡锁元件，其连接到滑块以跟随滑块的轴向运动，但是卡锁元件可以相对于滑块旋转。卡锁元件的可动元件被滑块接合，使得卡锁元件可以相对于滑块在两个不同位置之间移位：卡锁元件在轴向和旋向上锁定到滑块的第一位置，和卡锁元件仅轴向锁定到滑块但相对于滑块自由旋转的第二位置。
为了将卡锁元件和滑块的接合从第一位置移位到第二位置，注射按钮被使用，优选地使得注射按钮的轴向移动实现该移位。
定义：
“注射笔”通常是机械的即用户促动的注射设备，具有长椭圆形或者细长形状，有些类似用于书写的笔。虽然这样的笔通常具有圆形横截面，它们可以容易地具有不同的横截面，例如三角形、矩形或者正方形。
当在此使用时，术语“药品”是指包括能够以受控方式传递通过传送装置(例如中空针)的任何含药品的可流动药物，例如液体、溶液、凝胶或者细悬浮物。代表性药品包括诸如肽、蛋白质(例如胰岛素、胰岛素类似物和C-肽)和激素的药物、可生物地获得或活性剂、激素性和基于基因的药剂、营养配方和其他固态(分散)或液体形式的物质。
相应地，术语“皮下”注射是指包括到目标的皮下传送的任何方法。
此外术语“注射针”定义适于穿透目标的皮肤以达到传送或者去除液体目的的刺穿元件。
此处引用的所有文献，包括出版物、专利申请和专利，都通过引用而整体包含于此，并且达到如同每个对比文件被单独并且具体地指明通过引用被包括以及在本文中被整体陈述的相同程度。
此处所用的所有标题和小标题仅仅是为了方便起见并且不应当被解释为以任何方式限制本发明。
此处提供的任何和全部示例或者示例性预言(例如“例如”)仅仅意在更好阐明本发明，并且不对本发明施加任何限制，除非另外声明。说明书中的语言不应当解释为指示任何未要求保护的元素对本发明的实施必不可少。专利文献的引用和包括此处仅仅是为了方便起见，并且不反映这些专利文献的任何有效性、专利性和/或强制性的观点。
本发明包括可适用法律所允许的所附权利要求中记载的主题的所有修改和等价方案。
附图说明
以下将结合优选实施例并参照附图更全面解释本发明，附图中：
图1示出根据本发明的注射装置的剖视图。
图2示出图1中一部分的剖视图。
附图是示意性的并且被简化以便于清楚，并且它们仅示出对于本发明的理解必不可少的细节，而其他细节未示出。在整个附图中，相同标号用于相同或者相应的部件。
具体实施方式
当在以下使用“上”、“下”、“右”、“左”、“水平”和“垂直”、“顺时针”和“逆时针”或者类似相对表达的术语时，这些仅指附图，而不指使用的实际情形。示出的附图是示意性表示，由于这个原因不同结构的配置以及这些相对尺寸意在仅仅用作举例说明目的。
在该情形下，可以方便的定义附图中的术语“远端”意在指注射装置承载注射针的端部，而术语“近端”意在指离开注射针定向的相反端部。
图1公开了笔形注射装置1，包括在其近端的近端外壳10和在其远端的远端筒保持器20，近端外壳10保持剂量设定和注射机构，远端筒保持器20保持容纳液体药品的筒21。外壳10设置有内螺纹11和开口12，用户可以通过该开口12观察剂量设定，优选地通过放大镜。
在外壳10的最近端，支持有注射按钮30。此注射按钮30具有纵向形状并且通过可旋转连接31/41与剂量标度套筒40相接。剂量标度套筒40在其远端42处在外壳10的内螺纹11中被引导。剂量标度套筒40被透明护罩50覆盖，该透明护罩50不可旋转地连接到注射按钮30或者模制为注射按钮30的一部分。
在注射装置1中央设置活塞杆60。优选具有非圆形横截面的此活塞杆60具有近端螺纹61和远端螺纹62，这些螺纹优选地具有不同节距。远端螺纹62被外壳10的部分15内的螺纹16接合，该部分15将外壳10桥接到筒保持器20，使得活塞杆60可以通过旋转旋拧出此螺纹16并且进入筒保持器20。桥接外壳10到筒保持器20的外壳10的部分15可以被设置为单独的部分15，其以使得其不可轴向移动的方式连接到外壳10或者筒保持器20。近端螺纹61被驱动件70接合，该驱动件70具有接合近端螺纹61的内螺纹71。此外驱动件70通过连接32/72连接到注射按钮30，使得驱动件70可以与注射按钮30一起旋转但轴向可移动。
通过连接件64/84不可旋转地固定到活塞杆60的卡锁元件80在外壳10中位于远端。卡锁元件80包括远端环元件81和近端环元件82。远端环元件81以使得卡锁元件80可相对于滑块90旋转但轴向连接到滑块90的方式固定在滑块90中。
近端环元件82接合滑块90使得卡锁元件80锁定到滑块90，滑块90再通过轴向可移动的连接14/94锁定到外壳10，但是因为近端环元件82是挠性的，其可以通过在近端环元件82上提供轴向力而被推出与滑块90的接合。
卡锁元件80还设置有圆形轨83，该圆形轨由驱动件70上的类似突起73接合使得卡锁元件80和驱动件70可相对旋转但是在轴向上连接。
注射按钮30在远端设置有端部结束(End-of-Content，EoC)螺纹34，由可在外壳10中的纵向轨14中滑动的EoC螺母元件100接合。类似EoC机构的描述在EP1,250,167中提供。
当用户希望设定剂量时，注射按钮30被旋转，并由于连接32/72而促使驱动件70在活塞杆60上的近端螺纹61向上旋转。在剂量设定期间，活塞杆60通过与卡锁元件80的连接64/84而被固定不能旋转，该卡锁元件80通过近端环元件82和滑块90之间的接合而被锁定到外壳10。
当驱动件70在近端螺纹61向上旋转时，剂量标度套筒40通过接合31/41被向回拉出外壳10而不会旋转，但是因为剂量标度套筒40在外壳10的内螺纹11中被引导，所以它旋转。环绕剂量标度套筒40的护罩50也与注射按钮30一起旋转。
由于与滑块90的接合，可旋转安装到驱动件70的卡锁元件80在近端方向上轴向移动而不会旋转，该滑块90在外壳10的内表面上的轨14中滑动。
为了注射设定剂量，用户将手指放置在注射按钮30上并且施加轴向力。这将首先使注射按钮30相对于驱动件70移动几毫米，并且轴向力将施加在卡锁元件80的近端环元件82上，这将使卡锁元件80从滑块90松开。同时注射按钮30上的远端突起33将接合滑块90，从而促使注射按钮30轴向移动而不会旋转。
在驱动件70通过连接32/72在旋向上锁定到注射按钮30并且注射按钮30持续轴向运动的情况下，活塞杆60被促使旋转。因为连接件80在旋向上锁定到活塞杆60，连接件80也将旋转。因为卡锁元件80不再锁定到滑块90，此旋转是允许的。
注射按钮30和驱动件70的连续轴向向前运动将促使活塞杆60旋转并且在螺纹16中向前旋拧。活塞杆60的向前运动将促使橡胶活塞22在筒21内向前移动并且通过安装到筒21远端的未示出导管(例如注射针)将筒21内的一定量液体药品排出。
以上已经示出部分优选实施例，但应当强调的是本发明不限于这些实施例，而是可以在所附权利要求限定的主题内以其他方式实施。

Claims (7)

1.一种药品传送装置(1)，包括：
外壳(10)，
具有近端螺纹(61)和远端螺纹(62)的活塞杆(60)，
螺母元件(15)，其在外壳(10)中不可轴向移动并且具有与活塞杆(60)的远端螺纹(62)匹配的内螺纹(16)，使得活塞杆(60)在相对于螺母元件(15)旋转时在远端方向上被旋拧，
驱动套筒(70)，其具有与活塞杆(60)的近端螺纹(61)匹配的内螺纹(71)，使得当驱动套筒(70)相对于活塞杆(60)轴向移动时活塞杆(60)被旋转，
其中在活塞杆(60)和驱动套筒(70)之间设置可在第一位置和第二位置之间操作的可松开连接件(90、80、30)，该连接件(90、80、30)在第一位置中防止活塞杆(60)旋转同时允许驱动套筒(70)旋转，并且在第二位置中防止驱动套筒(70)旋转同时允许活塞杆(60)旋转。
2.根据权利要求1所述的药品传送装置(1)，其中该连接件(90、80、30)包括可滑动连接到外壳(10)的滑块(90)。
3.根据权利要求2所述的药品传送装置(1)，其中该连接件(90、80、30)包括连接到滑块(90)的卡锁元件(80)。
4.根据权利要求3所述的药品传送装置(1)，其中在第一位置该卡锁元件(80)在轴向上和旋向上锁定到滑块(90)。
5.根据权利要求3或4所述的药品传送装置(1)，其中在第二位置该卡锁元件(80)在旋向上从滑块(90)松开。
6.根据权利要求5所述的药品传送装置(1)，其中该卡锁元件(80)通过注射按钮(30)的轴向运动在其锁定和其松开位置之间切换。
7.根据权利要求6所述的药品传送装置(1)，其中该注射按钮(30)以使得注射按钮(30)可相对于驱动套筒(70)在轴向上移动的方式连接到驱动套筒(70)。
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