CN101500630B - 用于注射装置的联结器 - Google Patents

用于注射装置的联结器 Download PDF

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CN101500630B
CN101500630B CN2007800252161A CN200780025216A CN101500630B CN 101500630 B CN101500630 B CN 101500630B CN 2007800252161 A CN2007800252161 A CN 2007800252161A CN 200780025216 A CN200780025216 A CN 200780025216A CN 101500630 B CN101500630 B CN 101500630B
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M·范巴洛
L·U·尼尔森
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Novo Nordisk AS
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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
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    • 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
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    • 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
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    • A61M5/24—Ampoule syringes, i.e. syringes with needle for use in combination with replaceable ampoules or carpules, e.g. automatic
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    • A61M2005/2485—Ampoule holder connected to rest of syringe
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    • A61M2205/00—General characteristics of the apparatus
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    • 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
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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
    • A61M5/178—Syringes
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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
    • A61M5/31533—Dosing mechanisms, i.e. setting a dose
    • A61M5/31545—Setting modes for dosing
    • A61M5/31548—Mechanically operated dose setting member
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    • 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
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Abstract

本发明涉及具有封装在外壳内的容器和剂量设定机构的预填充注射装置。外壳由通过卡口式联结器锁定在一起的两个部件构成。除了卡口式联结器之外，该两个部件还设有将这两个部件永久锁定在一起的不可逆锁定装置。

Description

用于注射装置的联结器
技术领域
本发明涉及用于注射装置的卡口式联结器，且优选地涉及与不可逆锁定装置结合的卡口式联结器。
背景技术
通常以每日注射多次的一种疗法对糖尿病患者进行治疗，该疗法包括每天注射一次或两次长效胰岛素以满足基础需求，且辅以静脉推注(bolus injection)短效或速效胰岛素以满足食物相关的需求。
一般而言，使用两种不同类型的笔式系统用于治疗糖尿病。第一类型是具有可更换药筒的注射装置，该药筒容纳待注射的胰岛素。这类药筒常常容纳3ml胰岛素，当已经注射了这一剂量时，将新药筒插入同一注射装置中，因此该注射装置常常使用数年。这类注射装置通常称为持久注射装置。
例如在WO 99/16487和EP 897,728中公开了这类持久注射装置的一个示例，其中药筒通过卡口式联结器连接到注射装置。
另一类型是容纳预定的且不可更换的剂量(常常也为3ml)的胰岛素的注射装置。胰岛素常常容纳在嵌入注射装置的药筒中。当已经注射了预定剂量时(这平均约需要几天到一个月)，丢弃整个注射装置并使用新注射装置用于后继的注射。这类注射装置常常称为一次性预填充注射笔。
从US 6,004,297公知这类预填充注射笔的一个示例，其中形成外壳的部件不可逆地卡接在一起。
在将部件卡接在一起时，必须计算公差来一直激活卡接或咬合功能，即，公差必须使得在组装期间总是会到达不可返临界点(point of noreturn)。然而这会导致在机械锁定元件时引入一些松弛。
发明内容
本发明的目的是提供一种不会在锁定在一起的部件之间引入松弛的不可逆机械锁定。
正如一种例如从WO 99/16487公知的卡口式联结器具有这样的优点：当两个元件由于突起和卡口式螺纹的角度而相对旋转时，将这两个部件压在一起。
将这类卡口式联结器与将部件锁定在一起的不可逆机械锁相组合，使得该解决方案对于预填充注射装置而言很有吸引力，因为两个元件的压配合可以减少由于制造各种部件所涉及的注射模制过程而引发的松弛。机械锁可形成为当两个元件通过卡口式联结器充分地压在一起时机械锁锁定在其锁定位置内。这样可减少或甚至避免机械松弛。
该卡口式联结器设有当该两个部件被轴向地压在一起时固定这两个部件的卡锁(click-lock)。该卡锁包括突起和凹穴。突起和凹穴二者都倾斜，使得该凹穴形成陡峭边缘且该突起形成陡峭前沿。当该两个部件被轴向压在一起时，倾斜的突起在轨中滑动，直到该突起落入该凹穴中，且此时该突起的陡峭前沿在该凹穴的陡峭边缘后方锁定，从而防止该两个部件分开。
当陡峭边缘和/或陡峭前沿成角度时，外壳的该两个部件在相对旋转时将被更紧密地拉到一起。
凹穴的周向延伸大于轨的宽度，一旦突起进入凹穴，该两个部件就能相对彼此旋转。
将部件不可逆地锁定在一起的装置与该卡口式联结器分开定位，并包括纵向成形的隆起，该隆起沿斜坡被向上引导并突然被带入锁定凹穴中。该斜坡沿着注射笔的周向延伸，使得当该两个部件旋转并且该突起被移入该凹穴的周向延伸时，将该纵向成形的隆起沿该斜坡向上移动，直到其落在突然中断的斜坡之上并进入锁定凹穴中。
一旦纵向隆起固定在该锁定凹穴中，该两个部件就不能相对彼此旋转，并且在该突起位于该凹穴的周向延伸中时，该突起被形成该凹穴的凸起壁轴向固定，因此该两个部件不能分开。
定义
“注射笔”通常是具有拉长的或细长形状的注射设备，有点类似用于书写的笔。虽然这类笔一般具有管状截面，但它们可容易地具有不同的截面，例如三角形、矩形或方形或围绕这些几何形状的任何变型。
在本文中使用时，术语“药物”指的是包括任何能够以受控方式传递经过诸如中空针之类输送装置的含药物的可流动药品，例如液体、溶液、凝胶或微细悬浮液。代表性的药物包括诸如缩氨酸、蛋白质(例如胰岛素、胰岛素类似物和C-缩氨酸)之类的药品、以及荷尔蒙、生物衍生试剂或活化剂、基于荷尔蒙和基因的试剂、营养配方和呈固体(配制的)或液体两者形式的其它物质。
另外，术语“注射针”限定了适于穿透对象皮肤以输送或取出液体的穿刺构件。
“药筒”是用于描述容纳胰岛素的容器的术语。药筒一般由玻璃制成，但也可由任何适当聚合物成型。药筒或安瓿优选在一端通过能被例如注射针刺穿的可刺穿膜密封。相反端通过由橡胶或适当聚合物制成的柱塞或活塞封闭。柱塞或活塞能在药筒内可滑动地移动。可刺穿膜与可移动柱塞之间的空间保存胰岛素，当柱塞减小了保存胰岛素的空间体积时，胰岛素被压出。
本文所引用的所有参考，包括出版物、专利申请和专利都通过整体援引而被合并入本文，该引用的程度就如同每个参考均个别地且特定地表示为通过援引而被合并、以及如同在本文中被整体阐明一样。本文使用的所有标题和副标题都只是为了方便起见，不应理解成以任何方式限制本发明。
本文提供的任意和所有实施例、或者示例性语言(例如，诸如)的用法仅仅旨在更好地说明本发明，而不是限制本发明的范围，除非另外要求。说明书中的语言都不应理解成将任何未要求的元素表示为实践发明所必需的。在本文中引用和并入专利文献只是为了方便起见，而未反映出任何关于这些专利文献的有效性、专利性和/或可执行性的观点。
本发明包括了正如可适用法律所允许的在所附权利要求中所引用主题的所有修改和等效物。
附图说明
下面结合优选实施方式并参考附图对本发明进行更加全面的说明，在附图中：
图1表示现有技术的注射笔的分解图。
图2表示图1的现有技术的注射笔的剖面图。
图3表示组合的卡口式联结器和永久锁的分解图。
图4表示可替代的注射笔的分解图。
这些附图是示意性的，并且为清楚起见而被简化，它们仅仅示出了理解本发明所必需的细节，而省去了其它细节。在所有附图中，相同或对应的部件使用类同的附图标记。
具体实施方式
当在下文使用诸如“上”和“下”、“右”和“左”、“水平”和“垂直”、“顺时针”和“逆时针”的术语或类似相关表达时，仅仅参考附图而未参考实际的使用情况。所示的附图是示意图，为此不同结构的配置以及它们的相关尺寸仅旨在用于例示的目的。
在上下文中，这样定义可能比较方便：附图中的术语“远端”指的是注射装置承载注射针的端部，而术语“近端”意在指代远离注射针的相反端部。
图1和2公开了在US 6,004,297和US 6,235,004中公开并由NovoNordisk A/S公司以商标名FlexPen出售的注射装置。该注射装置包括剂量设定和注射机构以及容纳液体药剂的呈玻璃药筒形式的容器20。剂量设定和注射机构和容器20永久地嵌入外壳中。外壳包括两个部件：封装剂量设定和注射机构的第一近端部件1和称为药筒支架的第二远端部件10，该药筒保持件环绕容器20。
第一部件1和第二部件10优选地在制造注射装置期间以使得普通使用者几乎不可能将两个部件1、10分开的方式卡接在一起。这通过第二部件10上的边缘11与位于第一部件1的内表面上的槽2的接合而实现。容纳液体药物的药筒20以这种方式永久地嵌入第一部件1与第二部件10之间的连接部中。
剂量设定和注射机构从外壳开始包括：刻度筒30、连接管40、活塞杆引导件60和螺纹活塞杆80。螺纹活塞杆80在螺母构件70中向前旋拧将活塞底部75向前推入到容器20中。外壳的近端由固定在卡接元件95中的注射按钮90封闭。注射针15固定在外壳的远端。注射笔的远端优选由帽5覆盖。
此外，剂末(End-of-Dose)机构设置成被引导的内容物终端环50的形式。该机构在EP 1.250.167中加以详细描述。
图3公开了固定第一部件101和第二部件110的可替代方式。
第一部件101设有多个具备倾斜形状的突起102。在突起102的远端，顶面103与第一部件101的内侧面104齐平，而突起102沿近侧方向向内倾斜以形成斜坡。突起102的近端形成陡峭前沿105，陡峭前沿105相对于注射装置的垂直方向倾斜少许角度。
第二部件110设有多个开口轨111，如图4所示，在组装注射装置期间，引导螺母构件90的支脚91、92进入该开口轨111中。除了用于固定螺母构件90的这些开口轨111之外，还设置了多个第二轨112。当螺母构件90的支脚91、92位于开口轨111中时，这些支脚91、92还形成第二轨112的底面的一部分。第二轨112通向凹穴113中，凹穴113具有位于近侧的陡峭边缘115和向上通向第二部件110的内表面116的高度的倾斜底面114。凹穴113优选地与突起102形状相同，使得在组装注射装置时突起102能适配到凹穴113中。
陡峭前沿115相对于注射装置的垂直方向倾斜少许角度。
当第一部件101和第二部件110被推到一起时，突起102将在第二轨112中滑动并被引入凹穴113中。陡峭前沿105将落在陡峭边缘115之上，由此第一部件101和第二部件110卡接在一起。凹穴113的侧向尺寸大于突起102的侧向延伸，使得一旦突起102进入凹穴113中，第一部件101和第二部件110就能相对彼此旋转。由此，突起102从第二轨112移动并侧向进入至凹穴113中，由此突起102被轴向锁定在内表面116的升高至第二轨道112上方的部分的后方。
一旦陡峭前沿105被陡峭边缘115锁定，第一部件101和第二部件110用格外大的力才能拉开。
陡峭前沿105和陡峭边缘115一起形成在组装期间将两个部件101、110锁定在一起的卡锁105、115。然而，为了完全防止使用者拆开注射笔并可以接触到容纳液体药物的药筒20，除了卡锁105、115之外，还设置不可逆锁106、117。
通过使第一部件101上的纵向隆起106与位于外壳第二部件110的近端处的锁定凹穴117接合，形成了介于外壳的第一部件101与第二部件110之间的永久锁106、117。
锁定凹穴117形成在突然中断的斜坡118的端部处。斜坡118从较低高度处起始并向上倾斜，直到其被形成锁定凹穴117的陡峭锁定边缘119突然中断。斜坡118沿着第二部件110的周边倾斜。
为了锁定第一部件101和第二部件110，引导突起102通过第一轨道112并进入凹穴113中。一旦突起102卡入凹穴113中，纵向隆起106就在斜坡118的低高度之上运动。当第一部件101和第二部件110相对旋转时，随着纵向隆起106被推升上斜坡118直至该纵向隆起106从形成锁定凹穴117的陡峭锁定边缘119下落，突起102在凹穴113中侧向运动。由于纵向隆起106位于锁定凹穴117中，所以第一部件101和第二部件110不能相对彼此旋转，且由于突起102锚固在凹穴113中，所以两个部件101、110不能分开从而永久且不可逆地彼此固定。
由于陡峭前沿105和陡峭边缘115相对于注射装置的垂直方向倾斜少许角度，所以当两个部件101、110相对旋转时，随着突起102沿着注射装置的周边在凹穴113中侧向旋转，第一部件101和第二部件110彼此拉紧。
图4中公开的注射笔与PCT/EP2006/050800中描述的注射笔非常相似。
该注射笔包括由第一部件101和第二部件110构成的外壳，第二部件110在不使用时由帽25覆盖。帽25可设有辅助使用者操作注射针的装置，例如具有一孔，该孔可在进行注射的同时固定注射针的内帽。外壳的两部件中任一个均可在外表面上设有防止注射笔在一表面上滚动的球形突出120。容纳药物的药筒20位于第二部件110中，且螺杆(thread tower)30固定至第一部件101。
另外，剂量设定和注射机构从外壳开始包括：护罩40、刻度筒50、连接管60、活塞杆引导件70和活塞杆80。
护罩40连接至按钮45，按钮45可在外表面上设有柔软抓握纹路(grip texture)。具有支脚91、92的螺母构件90通过与第二部件110的开口轨111接合的支脚91、92而固定至外壳的第二部件110。螺母构件90还具有与活塞杆80的键状部81匹配的键状开口93，使得活塞杆80能在螺母构件90中轴向滑动。螺母构件90还具有多个与设置在活塞杆引导件70中的齿环71接合的棘齿臂94，使得活塞杆引导件70相对于螺母构件90只能在一个方向上旋转。
活塞杆引导件70设有与活塞杆80上的外螺纹81接合的内螺纹72，使得当活塞杆引导件70旋转时，活塞杆80在螺母构件90中向前移动。棘齿接合93、71使得活塞杆80只能向前，即，沿远侧方向移动。
在PCT/EP2006/050800中关于图8和9描述了注射笔的作业。
以上已经示出了一些优选实施方式，但要强调的是，本发明不限于这些实施方式，而是能在所附权利要求中限定的主题内以其它方式表现出来。例如附图公开了本发明的呈拉长笔状物体形式的注射装置，然而该具体形状绝不像权利要求限定的那样限制本发明。

Claims (4)

1.一种用于进行药品注射的设备，包括：
外壳(101，110)，其具有纵向轴线；
容纳液体药品的容器；
剂量设定和注射机构，
其中，容器与剂量设定和注射机构封装在外壳(101，110)中，外壳(101，110)包括通过卡口式联结器(102，112，113)锁定在一起的第一部件(101)和第二部件(110)，外壳(101，110)还包括用于将第一部件(101)和第二部件(110)永久锁定在一起的不可逆锁定装置(106，117)，其中，所述不可逆锁定装置(106，117)与卡口式联结器(102，112，113)分开，且所述不可逆锁定装置(106，117)包括位于第一部件(101)和第二部件(110)的一个中的隆起(106)，以及设置在第一部件(101)和第二部件(110)的另一个中的突然中断的斜坡(118)，且隆起(106)的纵向形状近似平行于所述纵向轴线。
2.根据权利要求1所述的用于进行药品注射的设备，其特征在于，第一部件(101)和第二部件(110)中的一个包括近似平行于所述外壳的纵向轴线的至少一个轨(112)，该至少一个轨(112)终止于凹穴(113)中，并且其中第一部件(101)和第二部件(110)中的另一个包括突起(102)。
3.根据权利要求2所述的用于进行药品注射的设备，其特征在于，凹穴(113)和突起(102)都倾斜，使得倾斜的凹穴(113)形成陡峭边缘(115)，且倾斜的突起(102)形成陡峭前沿(105)，且其中当第一部件(101)和第二部件(110)被轴向压在一起时，倾斜的突起(102)在所述至少一个轨(112)中滑动，直到该突起(102)落入该凹穴(113)中，且此时该突起(102)的陡峭前沿(105)在该凹穴(113)的陡峭边缘(115)后方锁定，从而防止所述第一部件(101)和第二部件(110)分开。
4.根据权利要求1-3中任一项所述的用于进行药品注射的设备，其特征在于，突然中断的斜坡(118)从较低高度处起始并向上倾斜，直到其被形成锁定凹穴(117)的陡峭锁定边缘(119)突然中断，所述隆起(106)适配到锁定凹穴(117)中，从而将第一部件(101)和第二部件(110)不可逆地锁定在一起。
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EP2040780A1 (en) 2009-04-01
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JP2009540986A (ja) 2009-11-26
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US20090254043A1 (en) 2009-10-08
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