CN1243578C - 注射器 - Google Patents
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- CN1243578C CN1243578C CNB998014478A CN99801447A CN1243578C CN 1243578 C CN1243578 C CN 1243578C CN B998014478 A CNB998014478 A CN B998014478A CN 99801447 A CN99801447 A CN 99801447A CN 1243578 C CN1243578 C CN 1243578C
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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
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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
- 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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- 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
- A61M5/31553—Mechanically 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
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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
- A61M5/31565—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
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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
- A61M5/24—Ampoule syringes, i.e. syringes with needle for use in combination with replaceable ampoules or carpules, e.g. automatic
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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
- A61M5/3129—Syringe barrels
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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
- A61M5/31556—Accuracy improving means
- A61M5/31558—Accuracy improving means using scaling up or down transmissions, e.g. gearbox
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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
- A61M5/31565—Administration mechanisms, i.e. constructional features, modes of administering a dose
- A61M5/31566—Means improving security or handling thereof
- A61M5/31573—Accuracy improving means
- A61M5/31575—Accuracy improving means using scaling up or down transmissions, e.g. gearbox
Abstract
一种注射器包括:一个外壳(1),一个具有非圆截面和外螺纹(7)的活塞杆(6),一个活塞杆驱动件,它包括一个与活塞杆(6)截面配合的活塞杆导向件(85)和一个螺母件(4),螺母件(4)不可沿轴向移动并与活塞杆(6)螺纹(7)配合而形成自锁的螺纹连接,以及一个剂量设定机构,它包括一个不自锁的螺纹连接,由于转动一个剂量设定件(81),一个注射钮(88)沿着上述螺纹连接被拧出,从外壳(1)突出,由于注射钮(88)沿轴向退回,上述螺纹连接把该轴向运动转换成活塞杆驱动件之一(85)相对于另一个(4)的转动。在螺母件(4)和活塞杆导向件(85)之间的单向联接件容许沿着一个使活塞杆(6)朝远端移动的方向作转动。单向联接件具有在产生转动之前必须克服的初始阻力,上述阻力大到足以抵抗在设定剂量时施加的扭矩。
Description
本发明涉及了一种注射器,用于从一个针剂筒分配药物的设定剂量,针剂筒包含着足以预备多份治疗剂量的药物量。
这种注射器主要用于要经常对自己进行注射的使用者,如糖尿病患者。对这种注射器规定了许多要求。剂量的设定必须明确无疑,必须易于读出设定的剂量。应该可以很不费劲地取消和改变错误设定的剂量,并且当注射剂量时剂量设定必须回到零。如果考虑一次性的注射器,即在针剂筒变空时就被丢掉的注射器,注射器还必须便宜,并且采用适于再生和烧毁而不产生有害气体的材料制成。为了这些目的,构成注射器的零件数目和用于注射器的不同材料数量应尽量少。
大多数剂量设定装置采用一个与螺母配合的带螺纹活塞杆,其中螺母和活塞杆可相互转动。把螺母从一个止动件位置拧出,可以达到剂量的设定,在螺母件靠到止动件之前一直压下活塞杆,使螺母在注射时回到止动件位置。对于其它的剂量设定装置,螺母或活塞杆之一的零件保持不转,而容许另一个零件根据设定的剂量转动一个设定的角度,由此把活塞杆通过螺母拧动一定的距离。
在分配设定剂量的大多数注射器中,在注射时活塞杆最好支承着受活塞杆作用的活塞。为此要采取措施防止活塞杆朝近端方向移动。
EP 327 910的注射器是属于从止动件位置拧出螺母的类型。在设定剂量时,沿两个方向均可拧动,从而只要沿反方向转动螺母,就可降低太大的设定剂量。设置了防止设定负剂量的装置。相对于笔形外壳转动一个帽盖,可达到活塞杆与螺母之间的相互转动,并可依靠刻度和指针读出设定的剂量,刻度和指针设在外壳和帽盖的相邻侧面上,这些侧面形状作成当指针指到零刻度时,帽盖只可能牢固地装在外壳上。可以看出一个缺点:对于比转动各零件360°所得还要大的剂量,必须把刻度上指示数和印在螺母管状延伸区侧面上的数相加后才能算出。螺母的管状延伸区与设定剂量成比例地从外壳近端移出,并且其近端被封闭形成一个注射钮。
在EP 450 905中克服了上述缺点,它沿着在螺母管状延伸区上的螺旋线写下数字,从而这些数字可以顺序地在封闭上述管状延伸区的外壳中的一个窗口内看到。由此明确无疑地指示了剂量的大小,但使用者必须记住在进行下一次剂量设定之前把剂量设定装置设为零。如果忘记,则会设定错误的剂量,并且在窗口内不能清楚地看出数字。
在EP 608 343中,说明了一种具有剂量设定机构的笔,其中,相对于外壳转动一个钮来设定剂量。由于转动,钮沿着一条螺线从外壳端拧出,螺线的螺距大到使螺纹连接为不自锁,也就是说,如果把钮压回到外壳端,则它将沿螺线转动退回。钮通过一个棘爪与一个驱动件联接,棘爪形成了一个单向联接件,在钮沿着一个方向转动来设定剂量时,它跨过或滑过棘轮的齿。钮的圆柱侧面上带着数字,当钮拧出时在窗口内显示了设定剂量的大小。当钮拧回时,单向联接件把转动传到驱动件上,驱动件具有一个螺母,螺母与在外壳中作成不转动的带螺纹活塞杆配合。该螺纹连接的螺距使螺母在活塞杆上自锁。克服弹簧力使棘齿的接合零件脱离接合,使得钮的转动不传到驱动件上,然后把钮压回到外壳,就可取消已设定的剂量。这种笔满足了上述所有目的,仅设定剂量的取消过程有点麻烦,因为如果设定的剂量太大,则由于拧动太容易,钮不能正好拧回。同时,克服弹簧力迫使联接的零件分开,以及钮的压下或拧回可能有点困难,弹簧的要求需要在注射器中采用金属零件。
本发明的目的是提供一种注射器,它具有上述优点而没有现有注射器的已知缺点。
这可由一种注射器来达到,用于从一个针剂筒分配药物的设定剂量,针剂筒包含着足以预备多份医疗剂量的药物量,注射器包括:
一个外壳
一个具有非圆截面和外螺纹的活塞杆
一个活塞杆驱动件,它包括两个零件:
a)一个活塞杆导向件,活塞杆相对于它作轴向移动,但不可转动,以及
b)一个螺母件,它在外壳内可转动,但不可沿轴向移动,并且具有与活塞杆螺纹配合的内螺纹,以形成自锁的螺纹连接,
一个剂量设定机构,它包括一个不自锁的螺纹连接,由于相对于上述外壳转动一个剂量设定件,一个注射钮沿着上述螺纹连接从外壳的近端拧出,从该近端突出了一个由上述转动角度决定的距离,以及由于注射钮沿轴向退回,上述螺纹连接把该轴向运动转换成活塞杆驱动件之一相对于另一个的转动,
本发明注射器的特征在于:
在螺母件和活塞杆导向件之间设置了一个单向联接件,容许这些零件可沿一个方向而不可沿相反方向相互作相对转动,容许的转动方向是把活塞杆在注射器内朝远端移动的转动方向,单向联接件被设计成在产生转动之前必须克服设定的初始阻力。
在设定剂量时,沿着一个方向对单向联接件施加一个力矩,在克服设定的初始阻力之后才容许该单向联接件沿着该方向作转动。因为上述力矩是一个弱力矩,它是在不自锁螺纹连接的公母件相互作相对转动时产生,所以可把初始阻力作得足够大,使得该转动不会引起单向联接件中各零件的任何相对转动。
当压下注射钮时,该钮的运动转换成活塞杆(或螺母件)相对于螺母件(或活塞杆)的转动。当使劲按压下注射钮时,初始阻力被克服,从而活塞杆和螺母件这两个零件可相互作相对转动。
按照本发明,在外壳和相对于外壳作转动用于设定剂量的零件之间建立了一个上扣联接,该联接提供了一个抵抗转动的中等阻力。由此保证了相应于设定剂量的位置得到保持,并且不会因疏忽而被改变。可以把上扣的卡搭声作为指示设定剂量大小的听觉信号。
单向联接件可以是这样的联接件:它包括一个可滑过棘轮的棘爪,棘轮的齿具有陡峭的前侧面和斜坡形的后侧面,由于棘轮齿的后侧面具有一个与棘爪上相配突起接合的凹陷,可以产生初始的阻力。
一个剂量刻度转筒可以与注射钮连接而与该钮一起沿轴向移动,剂量刻度转筒的表面上有一条螺旋道,与外壳内侧面上的一条螺旋肋接合,在外壳和转筒之间形成了不自锁的螺纹连接。这样,当剂量刻度转筒与注射钮一起在上述外壳中沿轴向移动时,它将相对于外壳作转动。
在设定剂量时从外壳拧出注射钮的螺纹连接可以是剂量刻度转筒和外壳之间的螺纹连接。此时,剂量刻度转筒必须与驱动件连接,在压下注射钮时,驱动件使活塞杆(或螺母件)相对于螺母件(或活塞杆)作转动。
相对于外壳转动一个零件来设定剂量,该零件可以是一个带着螺母件和单向联接件的零件,从而通过上述单向联接件把转动传到剂量刻度转筒上。所传递的转动沿着这样的方向:当初始阻力被克服时联接件可以沿这个方向自由运动。但是,把剂量刻度转筒沿其螺纹朝上拧出所需的力不足以大到克服上述阻力,因此可通过联接件来传递转动。
在本发明注射器的一个实施例中,相对于外壳转动的零件可以是一个带着螺母件和单向联接件的零件,通过单向联接件把转动传到剂量刻度转筒上。
在本发明注射器的另一个实施例中,相对于外壳转动的零件可以是注射钮,决定注射钮升高的不自锁螺纹连接可以是注射钮孔中的内螺纹,它与活塞杆增大区上的外螺纹接合。当注射钮沿着活塞杆朝上拧出而从外壳突出时,一个扭矩施加在活塞杆上,试图沿着使活塞杆在注射器中朝远端移动的方向转动该活塞杆。这种转动正好是单向联接件所容许的转动,单向联接件阻止沿相反方向的转动。由于抵抗单向联接零件之间相互转动的初始阻力,当注射钮在注射器中朝近端方向沿着活塞杆拧出时,活塞杆将不转动。如果沿相反方向拧动注射钮,则单向联接件将肯定阻止活塞杆和螺母件沿着会朝近端拉出活塞杆的方向作相对转动。
在上面提到的后一个注射器实施例中,剂量刻度转筒装在注射钮上可以转动,但不可以沿轴向移动。当剂量刻度转筒与注射钮一起沿着注射器的轴向移动时,由于在上述转筒和外壳之间的不自锁螺纹连接,转筒将作转动,从而转筒上相应于设定剂量的数字可在外壳壁中设置的窗口内看到。在该实施例中,剂量刻度转筒的螺距不需要完全相同于拧动注射钮来设定剂量所沿着的螺距,这两个螺纹连接仅必须均具有大螺距,大到足以使螺纹连接成为不自锁类型,也就是说,成为轴向移动可转换成转动的类型。
在本发明注射器的一个适当的实施例中,剂量刻度转筒装在注射钮上可以转动,但不可以沿轴向移动。
在注射时,注射钮必须保持不可转动,但可以沿着在设定剂量时注射钮转到的角度位置,相对于外壳作轴向移动。这可以这样来达到:使外壳和注射钮之间的上扣联接包括了在一个零件上的突起,突起与另一个零件上的轴向凹槽相接合。当把注射钮朝外壳压到底时,该钮的孔中内螺纹将作用到活塞杆端增大区上的相配外螺纹上,把注射钮的轴向运动转换成活塞杆的转动运动,转动沿着使活塞杆通过螺母件朝注射器远端拧动的方向。当沿联接件容许方向作转动的阻力被克服时,与单向联接件中一个零件连接的活塞杆导向件被容许作转动。此外,由于注射钮的轴向运动引起剂量刻度转筒的转动运动,从而当把钮压到底时,刻度回到其零位置。当由于注射钮的轴向运动引起剂量刻度转筒和活塞杆转动时,该钮受到一个扭矩的反作用,这个扭矩必须被注射钮和外壳之间的上扣连接所吸收,因此这个连接必须强到足以吸收这个力而不产生转动。
以下参照附图更详细地描述本发明,其中
图1表示了本发明注射器一个实施例的正视图,
图2表示了沿图1中II-II线的剖视图,
图3表示了图1注射器的缩小比例的分解视图,
图4表示了沿图1中IV-IV线的剖视图,
图5表示了沿图1中V-V线的剖视图,
图6表示了本发明注射器另一个实施例的正视图,
图7表示了沿图6中VII-VII线的剖视图,
图8表示了图6注射器的缩小比例的分解视图,
图9表示了沿图6中IX-IX线的剖视图,
图10表示了沿图6中X-X线的剖视图,
图11表示了本发明注射器另一个实施例的侧剖视图,
图12表示了与图11视图垂直的侧剖视图,
图13表示了图11和12中注射器的缩小比例的分解视图,
图14表示了本发明注射器另一个实施例的剂量设定部分的侧剖视图,
图15表示了本发明注射器又一个实施例的侧剖视图,
图16表示了与图15视图垂直的侧剖视图,
图17表示了图15和16中注射器的缩小比例的分解视图。
首先作出下列规定是方便的,即在本申请中总是从注射器近端来观察转动方向,沿该方向观察来设定顺时针或逆时针的转动方向。
图1表示了一种注射器,由此可把针剂筒中的液体分配成许多单独设定的剂量。图3表示了该注射器的分解视图,图2、4和5表示了沿图1中不同线所取的剖视图。
注射器包括一个管状外壳1,外壳被隔壁15分成第一区和第二区,一个卡紧锁扣把一个针剂筒套管2卡在外壳的第一区中,卡紧锁扣包括了在针剂筒套管2上的环形凸圆边3,该凸圆边在外壳开口端附近,卡在外壳1内壁中相应的周向槽内。采用这种卡紧连接,把针剂筒套管2固紧在外壳1中,使得它可以相对于外壳转动,但不能沿轴向移动。
在准备使用注射器时,把一个针剂筒装在针剂筒套管内,然后在其远端被一个设有针座容纳部分的端壁所封闭,在针座容纳部分上可安装一个针座,针座有一个针,一端与针剂筒内的液体连通,另一端可自由地插入患者体内。但在图示的注射器中,针剂筒、端壁或针座均未表示。
针剂筒套管2插入外壳1的一端被壁4所封闭,壁4具有一个带内螺纹5的中心孔。一个活塞杆6延伸通过上述孔,活塞杆6具有与上述孔内螺纹5配合的外螺纹7。把螺纹设计成使得顺时针转动活塞杆将驱动该活塞杆进入外壳1第一区中的针剂筒容纳室8。在突入室8的端部上,活塞杆6设有一个压脚9,它被设计成靠在一个活塞上,活塞封闭了容纳在针剂筒套管2内的针剂筒后侧。
在端壁4的近端面上孔被扩大,扩大区的内侧面上设置了棘轮齿10,齿具有面对着顺时针方向的陡峭前侧面11,以及面对着逆时针方向的斜坡形后侧面12。至少有一个棘爪13装在活塞杆导向件14上,棘爪与棘齿10配合,使得上述活塞杆导向件14只能在针剂筒套管2内作顺时针方向转动。
在外壳1第二区的内壁上设置了一条螺旋形的突起肋16,规定为大螺距的内螺纹。一个剂量刻度转筒17的外壁上设置了一条螺旋形槽,规定为与上述内螺纹配合的相应外螺纹。螺纹的螺距角超过了形成螺纹连接零件材料的摩擦角,因此螺纹连接是不自锁类型,当这些零件沿轴向相互移动时,可引起各连接零件的相对转动。
指示设定剂量的数字印在剂量刻度转筒17的外壁上,与所设定剂量相应的数字显示在外壳1侧壁中的窗口18内。
剂量刻度转筒17上设有管状延伸区21,其一端靠近注射器的近端。上述延伸区端部被具有中心朝外突起20的端壁19所封闭。在靠近端壁19的壁区中,延伸区21上设有几条狭槽22。上述延伸区端部被形成注射钮的杯形帽盖23罩住。该帽盖开口端上的内钩24卡住了延伸区21上的周向外凸圆边25,在端壁19上的突起20靠在帽盖23底部的内侧,形成了一个枢轴,注射钮可绕着它相对于延伸区21作转动,但不能相对于该延伸区作轴向移动。
一个与活塞杆导向件14作成整体的驱动管26从该活塞杆导向件延伸到剂量刻度转筒延伸区21的端壁19,并且在其近端被分成几个舌片27,舌片端上设有与延伸区21中狭槽22接合的外钩28。这样,剂量刻度转筒17必然与驱动管26一起作转动,但可相对于该驱动管作轴向移动。
为了设定剂量,针剂筒套管2在外壳1第一区内沿逆时针方向作转动。该转动是在克服一个阻力下完成的,该阻力由于以下事实所产生:在针剂筒套管外壁上的一个突起30留在沿周向设在上述外壳第一区内壁上的许多凹陷31之一中,如图5的截面视图所示。适当地作出各凹陷之间的角度间隔,使得当突起从一个凹陷移到相邻凹陷时设定了一个剂量单位,从而在设定剂量的转动时,听到和感觉到的上扣卡搭声数目相应于设定剂量的大小。
由于相接合螺纹5和7中的摩擦,把针剂筒套管的转动传到活塞杆6,并且还通过单向联接件把转动传到活塞杆导向件14,虽然所传递的扭矩是沿着棘爪会滑过棘轮齿10的方向。但是,在实现这个松扣功能之前,必须克服一个阻力。这个阻力的产生是由于:在与棘轮齿10接合的端部上,棘爪13有一个突起29,以及在棘轮齿的斜坡形侧面12内设有凹陷32,棘爪13上的突起29将留在凹陷内。在使单向联接件松扣之前,必须提供一个足以从斜坡形侧面12凹陷32中提起棘爪13突起29的扭矩。总之,可把一个中等的扭矩从转动的针剂筒套管2传到驱动管26。因为在驱动管26近端上的钩28与剂量刻度转筒延伸区21中的狭槽22接合,剂量刻度转筒将被转动,并且在外壳1的第二区中朝上拧出,注射钮23将被升高而从外壳1的近端突出。因为朝上拧动剂量刻度转筒仅需要小的扭矩,因此可以达到这一点而不会使单向联接件释放成为松扣功能方式。现在可在窗口18中出现的剂量刻度转筒部分上,看到所设定剂量的大小。如果所设定的剂量太大,可沿着顺时针方向转动针剂筒套管,直到与所需剂量大小相应的数字出现在窗口18中为止。
为了注射所设定的剂量,把注射钮23朝着外壳1内的方向压到底。由此朝远端方向压下剂量刻度转筒17,由于在上述转筒和外壳1之间的螺纹连接,有一个扭矩施加在转筒上,使这个转筒沿顺时针方向转动。通过转筒延伸区21中的狭槽22和驱动管26端上的钩28,以及驱动管本身,把上述扭矩传到活塞杆导向件14。当扭矩强到足以克服棘爪突起29与棘轮齿斜坡形侧面中凹陷32接合造成的阻力时,容许活塞杆导向件上的棘爪13沿顺时针方向转动。
只要使劲压下注射钮23,就可以提供这种强扭矩。现在活塞杆导向件14与处于松扣方式的单向联接件一起作顺时针方向转动,活塞杆也作顺时针方向转动,由此通过壁4进一步拧入针剂筒容纳室8内。单向联接件永远不容许活塞杆导向件和活塞作逆时针方向转动,这样,它保证了在室8中图中未示的针剂筒内,压脚9永远不会被拉开而脱离与活塞的贴合。
在所示的实施例中,具有螺纹孔的端壁4形成了一个螺母件,由活塞杆导向件14和驱动管26使活塞杆相对于螺母件作转动。可以把实施例设想成:其中把活塞杆导向件设在壁4中,以及由驱动管使螺母件作转动,这种实施例不超出本发明的范围。
参照图6-10来描述另一个实施例。与图1-5所述实施例中零件相应的零件具有相同的编号。与图1-5实施例不同之处是:在注射钮23上,而不是剂量刻度转筒17上设有延伸区33,以及省去了驱动管26。另外,注射钮23上设有凸缘32,当把注射钮压到底时凸缘靠在外壳端边上。延伸区33作为剂量刻度转筒17的枢轴,剂量刻度转筒17在该枢轴上自由转动,但由于在延伸区33一端的钩34,它必然随着注射钮23作轴向运动。在注射钮及其延伸区33中的纵向孔35中设有内螺旋肋36,它与活塞杆近端上增大区37的螺旋槽接合,在上述钮23和上述活塞杆6之间形成了螺纹连接。该螺纹连接的螺距作成不自锁的螺纹连接。
为了设定剂量,沿顺时针方向用手转动注射钮23。由此从外壳1朝外拧出该钮,因为通过活塞杆导向件14和单向联接件,活塞杆6将保持不转,虽然上述单向联接件受到沿其松扣方向的扭矩影响,但由于已提供的初始阻力,活塞杆导向件14不会立即转动。在朝外的运动中,注射钮23将随着它把剂量刻度转筒17拉出。当该转筒在外壳中沿轴向移动时,由于在上述转筒17和外壳1之间的不自锁连接,转筒将被转动。
对于这种构造,注射钮朝外拧出所沿着的螺纹和剂量刻度转筒在外壳中转动所沿着的螺纹可以不一样。
在图6的实施例中,在注射钮23和外壳1之间,设置了一种与图1实施例中针剂筒套管2和外壳1之间连接相当的上扣连接,其中设在外壳内壁上的一个或几个突起38与注射钮23圆柱形外壁上的槽39接合。由此在所有可能的角度位置上,容许注射钮作轴向运动。
当压下注射钮来注射设定的剂量时,上述钮在轴向运动时将保持不转,因为在外壳内壁上的上述突起和在钮外壁上的槽之间的锁定强到足以吸收施加在注射钮上的扭矩,此时,在克服了沿单向联接件松扣方向转动的阻力之后,注射钮驱动着活塞杆沿顺时针方向转动。
图11、12和13中所示的实施例具有带窗口18的外壳1。具有内螺纹5的端壁4设于装在外壳一端的单独构件40中,构件40具有与外壳中的狭槽42接合的突起41,把构件40锁定在外壳1上。另外,构件40的周边上具有纵向凹槽43,凹槽与外壳中图中未示的内肋接合,把构件40锁定成不能相对于外壳1作转动。另外,在针剂筒套管2上的突起44与狭槽42接合,把针剂筒套管2锁定在外壳1上。
活塞杆6以它的外螺纹7与端壁4的内螺纹接合,并且在针剂筒套管内的一端上设有一个压脚9,活塞杆6可相对于压脚作转动。驱动管45的一端设有棘爪13,它与构件40中的棘轮齿接合,并保持在外壳的环形壁46和构件40的壁4之间,限制了驱动管45的轴向运动,但容许它作转动。在驱动管45的内壁上具有一个键,它与活塞杆6中的纵向凹槽接合。由此把驱动管的转动传到活塞杆6,但活塞杆可以沿驱动管45的轴向自由移动。在驱动管45的外表面上具有一条外螺纹47,它与螺母件48中的内螺纹50接合,螺母件48的远端上具有一个凸缘49,近端上设有一个直径缩小的部分51,管状部分52的一端与部分51固定连接,管状部分52的另一端带着一个钮23。
在外壳1的近端,一个衬套53被固定成相对于上述外壳1不可转转动和移动,外壳1近端上的突出部分54与衬套53周边上的凹口55相接合而造成转动的锁定。一个导向件56可沿着衬套53作纵向移动,但不可相对于上述衬套作转动,因而也不可相对于外壳1作转动。导向件56的远端上具有一个环形端壁57。螺母件48的部分51通过上述端壁57的开口,并且具有一条凸圆边58,卡紧在通过上述端壁的环形开口中的周向内凹槽内,使衬套53固定到上述部分51上,从而该部分可相对于衬套53作转动,但不可沿轴向移动。剂量刻度转筒17以枢轴方式支承在螺母件48上,并且把凸缘90保持在导向件56的端壁57和由部分51与螺母件48连接处形成的肩部之间,使得剂量刻度转筒17保持在该螺母件上。
钮23可转动地保持在导向件56上,导向件56具有环形凸圆边59,它与钮23内壁中的周向凹槽60接合,凹槽60比凸圆边59宽一些,使得钮23除了可在上述衬套53上转动之外,还可以沿轴向移动一定距离,该距离由凹槽60相对于凸圆边59的宽度来确定。由于管状部分52中的内肋61与螺母件48部分51的近端区中的狭槽62接合,使钮23与螺母件48联接。该联接迫使钮23和螺母件48相互一起转动,但容许有少量的相对轴向移动。
导向件56的近端表面具有一个或几个沿轴向的突起63,它可与钮23底部中的径向凹槽64接合,但主要被偏置成使得这些凹槽和突起不接合。另外,导向件56近端上至少有一个径向突起65,它被偏置成与钮内壁中的轴向凹槽66接合,以便在钮23相对于衬套每次作转动而使突起从一个凹槽跳到相邻凹槽时,产生一个上扣的卡搭声。
为了设定剂量,沿顺时针方向转动钮23。由于肋61和狭槽62之间的联接,该转动传到螺母件48上,然后螺母件48沿着驱动管45朝近端拧动,由于棘爪13沿着构件40中棘轮齿运动的阻力,驱动管45在外壳1中保持不转。朝近端方向的螺母件运动使得剂量刻度转筒17、导向件56和管状部分52与钮一起朝近端方向移动,使得钮23高出外壳1的近端侧面。沿逆时针方向转动钮23可降低太大的设定剂量。
在转动钮23时,导向件56的径向突起65从一个轴向凹槽66上扣到另一个凹槽。可适当选择凹槽之间的距离,使得一个上扣卡搭声相应于设定剂量改变一个国际单位左右。由于剂量刻度转筒圆柱形壁上螺旋槽和外壳内壁上螺旋肋之间的接合,剂量刻度转筒17的运动将使上述转筒作转动和移动,从而把设定的剂量显示在窗口18中。
当剂量刻度转筒在外壳中朝外移动时,剂量刻度转筒17近端上锯齿91的陡峭前侧面将靠在衬套53上相似齿92的陡峭前侧面上,由此剂量刻度转筒的转动被停止,指示出已设定了最大的剂量。
为了注射设定的剂量,压下钮23。由此克服了使突起63和凹槽64不接合的偏置,并建立了上述接合。现在钮23相对于导向件56被锁定,导向件56相对于衬套53,因而相对于外壳1的转动也被锁定。管状部分52和螺母件48之间的联接使得该螺母件相对于外壳不转动,因此,由于该螺母件和驱动管45之间的不自锁联接,上述螺母件朝远端方向的轴向运动将使该驱动管45沿顺时针方向转动,并且由于在驱动管45和活塞杆6之间的键/槽联接,上述活塞杆将通过端壁4进一步拧入针剂筒套管的室内。在注射时对钮23转动的锁定保证了在注射时不会疏忽地改变设定的剂量。
在图14所示实施例中,提供了两个分开的钮来作剂量的设定和注射。相应于上述各个实施例,该实施例具有外壳1和驱动管67,由于棘爪与固定在外壳远端中一个零件上棘轮齿相接合,驱动管67仅可沿一个方向转动。棘爪夹在构件40和环形壁46之间,限制了驱动管的轴向运动。在驱动管67的外壁上设有轴向肋68,该肋与管状注射件70中轴向凹口槽69接合,把上述注射件的转动传到驱动管67上。
在外壳1的近端上安装了一个剂量设定钮71,使得该钮可相对于外壳1作转动,但不可作轴向移动。达到这一点是由于以下事实:在剂量设定钮71与外壳相配的部分上具有一条环形凸圆边72,它与外壳内壁中的周向凹槽73接合。在外壳之外的剂量设定钮部分具有与上述外壳直径相应或稍大的直径,该部分上设有许多轴向肋74,以保证在设定剂量时可用手指夹牢。剂量设定钮71具有一个中心孔,其内壁具有一条螺旋凹槽75,与注射件70近端区外壁上设置的螺旋肋76接合,注射件70通过剂量设定钮71的孔。注射件70的远端区外壁成为剂量刻度转筒17的枢轴,剂量刻度转筒17通过一条与外壳中内螺旋肋16接合的外螺旋凹槽而被转动,当剂量刻度转筒在外壳中沿轴向移动时,在窗口18内显示出设定的剂量。在注射件的近端上设有端壁77,它带着一个注射钮78,注射钮78依靠销轴79可转动地支承在上述端壁77的中心孔中。
为了设定剂量,沿顺时针方向转动剂量设定钮71。因为注射件70与驱动管67联接而保持不转动,在剂量设定钮71内壁上螺旋凹槽75和注射件70外壁上螺旋肋76的共同作用下,使注射件70通过剂量设定钮71拧出,从而注射钮78高出外壳的近端。虽然带棘爪的驱动管67可以沿顺时针方向转动,但需要有一个大于从剂量设定钮到注射件传递扭矩的初始扭矩才行。
为了注射设定的剂量,压下注射钮78,注射件70回到外壳中。在剂量设定钮71内壁上螺旋凹槽75和注射件70外壁上螺旋肋76的共同作用下,现在使注射件70沿顺时针方向转动,仅当使劲压下注射钮时,才可产生一个扭矩,大到足以克服棘爪机构沿上述顺时针方向转动的初始阻力。
把剂量设定钮71和注射钮78分开,可以使得在注射时不太容易误用了剂量设定钮。
图15、16和17说明了又一个实施例。为了保持顺时针转动剂量设定钮来增加设定的剂量,在驱动管和外壳之间工作的棘爪机构改成这样:它阻止驱动管的顺时针转动,并且有阻力地容许驱动管的逆时针转动。另外,活塞杆的螺纹和外壳端壁中的螺纹被设计成这样:活塞的逆时针转动将拧动活塞杆通过上述端壁并进入针剂筒套管的室内。活塞杆具有非圆截面,贴合地通过具有相应非圆截面的驱动管孔。这样,可传递转动,同时容许活塞杆沿纵向通过驱动管。
剂量刻度转筒80外壁上设有一条螺旋道,它与沿外壳1内壁的一条螺旋肋16接合。剂量刻度转筒80近端的直径超过外壳的内径,以形成一个剂量设定钮81,剂量设定钮81的圆柱形外壁上滚花,以保证可用手指夹牢。
一个衬套82在其近端上具有凸缘83,并且通过其侧壁具有相对着的一对纵向狭槽84,衬套82配装在剂量设定转筒80之内,并配装在驱动管85之外,驱动管85的外壁上具有钩86,它与衬套82的狭槽84相接合,由此衬套82和驱动管85相互联接,使得在上述两个零件之间可传递转动,但不可传递纵向移动。
在剂量设定钮81中设置了一个室,它具有一个沿周向设置了纵向凹槽的圆柱形侧壁,以及一个具有以三角形截面齿组成的齿花簇的底。衬套82的凸缘83容纳在上述室中,在其周边上具有一个径向突起87,它被偏压到室的侧壁上。在凸缘83的远端侧面上具有齿花簇93,它与室底的齿花簇接合。
衬套82装在剂量刻度转筒80中,在衬套82外壁上的突起与剂量刻度转筒80内壁上的凹槽接合,从而容许衬套在剂量刻度转筒中作受限制的运动,使得衬套可沿纵向相对于剂量刻度转筒作移动,造成或不造成上述齿花簇的相互接合。一个带有销轴94的注射钮88可转动地装在衬套82的端壁中。
在顺时针方向转动剂量设定钮81来设定剂量时,剂量刻度转筒被拧出外壳,剂量设定钮高出外壳的近端。由于衬套与顺时针转动被锁住的驱动管相联接,衬套保持不转,如果沿逆时针方向转动剂量设定钮81来降低设定的剂量,则在驱动管和外壳之间工作的棘爪机构足以抵抗沿其非锁定方向的转动,以防止衬套82跟随着这个逆时针转动。因此,对于剂量设定钮81在任何方向的转动,衬套82凸缘83上的径向突起87将从剂量设定钮81内壁的一个轴向凹槽上扣到另一个凹槽,各凹槽隔开成使得上扣一次相应于选定的剂量改变,如一个或半个剂量单位。在设定剂量时,剂量设定钮中的齿花簇迫使衬套82凸缘83上的齿花簇93脱离接合。
当压下注射钮88来注射设定的剂量时,上述两个齿花簇被压成接合,从而衬套82可跟随着剂量设定钮81的逆时针转动,这个逆时针转动是由于在剂量刻度转筒80被压回上述外壳时,剂量刻度转筒80螺旋道和外壳中肋16之间的螺纹接合所引起。衬套82使驱动管85沿逆时针方向转动,由此使得棘爪机构有阻力地容许活塞杆进一步拧入针剂筒套管2中的针剂筒89内。
采用这种装置,可以消除在注射时误操作剂量设定钮81的风险性。另外,装置由最少零件组成,因而易于制造。
Claims (8)
1.一种注射器,用于从一个针剂筒分配药物的设定剂量,针剂筒包含着足以预备多份治疗剂量的药物量,注射器包括:
一个外壳,
一个具有外螺纹的活塞杆,
一个活塞杆驱动件,它包括两个零件:
a)一个活塞杆导向件,它与活塞杆配合,以容许活塞杆相对于上述活塞杆导向件作轴向移动,但不可转动,以及
b)一个螺母件,它在外壳内不可沿轴向移动,并且具有与活塞杆螺纹配合的内螺纹,以形成螺纹连接,
一个剂量设定机构,它包括一个不自锁的螺纹连接,由于相对于上述外壳转动一个剂量设定件,一个注射钮沿着上述螺纹连接从外壳的近端拧出,从该近端突出了一个由上述转动角度决定的距离,以及由于注射钮沿轴向退回,上述螺纹连接把该轴向运动转换成活塞杆驱动件之一相对于另一个的转动,
注射器的特征在于:
在螺母件和活塞杆导向件之间设置了一个单向联接件,容许这些零件可沿一个方向而不可沿相反方向相互作相对转动,容许的转动方向是把活塞杆在注射器内朝远端移动的转动方向,单向联接件被设计成在产生转动之前必须克服初始阻力,该初始阻力被设置成大到足以抵抗在设定剂量时施加在单向联接件上的扭矩。
2.按照权利要求1的一种注射器,其特征在于:在外壳和相对于该外壳作转动用于设定剂量的零件之间建立了提供一个上扣联接,联接提供了一个抵抗任一转动的中等阻力。
3.按照权利要求1或2的一种注射器,其特征在于:单向联接件包括一个可滑过棘轮的棘爪,棘轮的齿具有陡峭的前侧面和斜坡形的后侧面。
4.按照权利要求3的一种注射器,其特征在于:棘轮齿的后侧面具有一个与棘爪上相配突起接合的凹陷。
5.按照权利要求4的一种注射器,其特征在于:剂量刻度转筒的表面上有一条螺旋道,它与外壳内侧面上的一条螺旋肋接合,在外壳和剂量刻度转筒之间形成了不自锁的螺纹连接,剂量刻度转筒与注射钮连接而与该钮一起沿轴向移动。
6.按照权利要求5的一种注射器,其特征在于:由于设定剂量而升高注射钮的螺纹连接是剂量刻度转筒和外壳之间的螺纹连接。
7.按照权利要求1或2的一种注射器,其特征在于:相对于外壳转动的零件是注射钮,决定注射钮升高的不自锁螺纹连接是注射钮孔中的内螺纹,它与活塞杆大直径区的外螺纹接合。
8.按照权利要求1或2的一种注射器,其特征在于:活塞杆导向件装在驱动管内,活塞杆可在驱动管内沿轴向移动,但与上述驱动管一起转动,在驱动管和可与注射钮一起沿轴向移动的零件之间,设置了决定注射钮升高的不自锁螺纹连接。
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