CN1420794A - 注射器的自动操作安全护套*** - Google Patents
注射器的自动操作安全护套*** Download PDFInfo
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Abstract
一种供注射器(60)用的自动操作安全护套***(10),其包括注射器(60)可***其中的内夹持器(20);从内夹持器(20)向外安装的外护套(30),它在缩回位置和伸展位置之间可轴向移动;定位在内夹持器(20)和外护套(30)之间的弹簧,该弹簧推动外护套(30)到它的伸展位置;内夹持器(20)有至少一个第一开口(130),在其远处有至少一个第一缺口(170),和外护套(30)有至少一个第一止动件(300),当外护套(30)处在缩回位置时第一止动件与开口(130)接合,当外护套(30)处在伸展位置时第一止动件与第一缺口(170)接合;通过定位在内夹持器中的触发器的动作或通过该注射器柱塞上的凸出部可以从外护套的缩回位置释放它。
Description
本发明涉及供注射器使用的自动操作安全护套***,以及自动操作安全护套***包括防止针头伤害的注射器。
针头伤害对健康有严重的威胁,因为这样的伤害常导致疾病从一个人传给另一个人。一旦发生针头伤害,通常需要将受伤的人隔离相当长的一段时间观察是否感染如HIV或肝炎,也可能需要限制他们从事工作的类型,或与他们一起工作的人。整个经历,即使伤员没有感染,对医疗提供者来说也是有高度的损害和沉重的经济负担。感染是完全不能接受的,如果针头伤害在最初的地方就能防止的话。针头伤害与频繁暴露于可能污染的环境以及经常与受感染病人接触的医疗职业者非常有关联。对针头伤害危险性的重视已经导致公众希望防止伤害的发生,并可得到各种类型的安全***,在使用之后或者收回针或者遮罩住它以便使针头伤害的可能性减至最小。在美国通过几项“清晰”的立法,以及医疗保险公司和医疗服务机构都鼓励和强制执行使用这样的安全***。
先有技术安全***的例子包括EP0966983,它的整个内容结合于此作为参考。EP0966983公开了一种预充填注射器的护套***,该***包括外注射器夹持器和内护套。使用中,包括有近处突缘、远端针头和包含柱塞的针筒的预充填注射器被***到由外夹持器和内护套限定的封闭体内,并由外封闭体夹持。当通过注射器针筒(例如在注射器针筒的内容物已经完全注射之后通过加在柱塞上的压力)对夹持器施加足够的压力使护套松脱并通过处在针筒和护套之间的弹簧将护套朝远端方向推动,将护套推到伸展位置并覆盖住针头。
但是,包括EP0966983的先有技术装置在它们的设计和结构中有许多缺点和潜在的问题。例如,EP0966983的装置有护套机构事故性触发的倾向,因为足够的力(如由于事故性跌落造成的)施加到注射器针筒上将随之把足够的力施加到外夹持器上而触发护套机构。还有,会出现这种情况,当用足够的力将注射器***到外夹持器/内护套结构中以便通过夹持器保持注射器时,也可能触发护套机构。另一种情况是,在护套与夹持器接合之前将注射器放入由夹持器限定的封闭体内,可以避免这种触发的可能性。但是,这样制造该装置的方法就有点复杂和繁琐,将会阻碍独立于供任何注射器使用的夹持器/护套结构的销售和分配。此外,实际触发护套机构需要分立的步骤,在柱塞杆上施加上比注射时更大的力,这要在从病人身上拔出针头之后进行(段落号27)。这意味着存在潜在的不可接受的时间段,在该阶段可能发生针刺,这要求在注射器使用中附加一个步骤。遇到的另一个缺点是弹簧伸展盖住注射器针筒。当给病人注射时这可能特别成问题,因为注射器针筒的内容物当弹簧伸展时不再能全部看见,尽管为了保证给病人注射合适剂量的药物可能必须要看到它们。类似地,伸展的弹簧使得很难看清注射器针筒上的任何标签,为了确认给病人注射的是正确的药物,这可能是必须的。
护套机构,包括护套、弹簧、触发机构和夹持器必须全都组装在一起(例如见EP0966983的图5),这个事实意味着安全护套结构可以是不希望的那么大。
常常需要使用注射器以特定的锐角***针(例如可能是必须在皮下很浅的深度内注射长效固体药物配方)以便避免“成核”,从而由针头开凿到组织的中心,依次这造成组织皮下出血和损伤并可能影响注射药物的效力。大体积的安全护套不能有手指夹(突缘),或围绕它们的整个外周边不能有至少一个有用的尺寸,来帮助获得在针头和病人的皮肤之间足够小(即浅的)角度,所以代替的措施是一般设有侧向伸展的径向彼此相对的突缘。一般这样操作它们,当针头进入皮肤时使突缘定位成不会接触皮肤(即:它们平行皮肤的表面的平面)。但是,压下柱塞(在注射如整个药物配方时可能需要以仔细和受控的方式施加相当大的力)可能证明是很困难的,因为突缘处在不方便的位置。使用者有时为了克服这个困难和获得良好的抓握突缘在针头已经进入皮肤之后将注射器转动90度(即:使突缘垂直于皮肤表面的平面)。但是针尖的大孔径和尖锐的边缘可能使转动从病人组织中切出一“核”,就象球场管理员在高尔夫路径的绿地上挖孔一样。这样,很自然是个问题并希望避免它。
美国专利5163918号公开一种一次性使用的安全注射器,它有可伸开的安全护套。但是,它的结构显然不同于本发明并有许多被本发明克服的明显缺陷。特别是,这些缺陷是由注射器针筒组成安全护套机构的一部分、由使用和定位露出的弹簧、由用注射器柱塞可以达到的有限的移动和由注射器采用的安全夹所造成的。
当保护套管不在缩回位置时还露出弹簧。当移动到伸展位置时,由弹簧夹住如使用者的手或绊住衣服等可以很容易阻碍其运动。在本发明各种实施例的装置中弹簧已经被封闭所以不会影响。
美国专利5163918号的保护套管还设有使用者可以抓住的手指夹。它们的使用意味着保护套管不能伸展到针头之上直到使用者在套管或者在活塞上的抓握或夹持之后。当针头在病人身上时这样做可能导致针头的突然移动和组织损害。因此,在针头已经从病人身上拔出之后才能安全地覆盖针头,并且在使用者有意识地让保护套管或柱塞移动之前做不到这一点,这就可能造成针头被不必要的暴露。本发明提供自动操作的护套***(即:它的操作是柱塞杆被全部压下的结果且无需使用者另外的干预),当针头从病人身上拔出时该***就覆盖住针头,保证针头不会暴露。本发明的自动操作***允许在一次流体运动中(压下柱塞杆)进行对病人给药和操作安全护套***两项任务。特别是,用来使保护套管伸展到针头之上的弹簧伸展到注射器针筒之上。如上所述,这是一个缺点,因为这可能损伤针筒,并可能妨碍对注射器针筒的内容物的观察,因此可能很难或不可能提供精确的药物剂量的计量。在给病人施加固体长效药剂时,医疗要求一般需要在注射之前和之后都可用目视很容易确定注射器针筒内长效药剂的存在(或已注射)。弹簧遮蔽注射器针筒将基本上阻碍这样做。
为了防止不希望的触发松脱机构,美国专利5163918号的柱塞设有可拆卸的安全装置,该装置包括可撕掉的带或可拆下的的帽,通过安全装置柱塞可自由移动但不会触发松脱机构。这可能造成给病人注射时,只有医师才能发现安全装置还没有拆下,这时必须缩回活塞以便允许拆下安全装置。这可能造成病人不舒服和受到伤害。本发明的实施例提供另一种安全装置,它必须在移动活塞之前拆下,从而避免了上述的问题。
还有,本发明的锁定机构利用(见下面)外护套止动件,它将琐定机构锁定在缩回的位置既防止该机构进一步伸展和缩回。相反美国专利5163918号要求附加的突片来达到相似的目的,很清楚给装置增加了不必要的复杂性。虽然本发明并不需要,在某些实施例中也装设附加的接合装置以便防止不希望的外护套进一步的伸展,这样使本发明在机械上更有弹性。
此外,美国专利5163918号的注射器的设计不可避免地使它比本发明的更大(更长)。当美国专利5163918号的保护套管移动到它的伸展位置时,它覆盖注射器针筒的主要部分。这意味着为了覆盖大的针头,需要长的保护套管和长的注射器针筒。这可能使整个注射器有点不必要的大而笨重,以它的尺寸会引起病人的忧虑。相反,在伸展位置,本发明的外护套覆盖注射器针筒相对不大的部分。这意味着本发明的装置可以更小和更方便。
在制造方面,美国专利5163918号的注射器必须作为完整的器件制造和销售。而本发明允许注射器的制造,可选地含有药物,与安全护套结构的制造分离,随后将两者组合起来。这意味着可以制备一批安全护套而无需承担制造整个装置的成本。类似地,可以保持预充填药物注射器的范围很宽,当需要时与安全护套组合。整体来说,这可以允许保持较小批量的部件(因而节省制造商的钱)和使制造工艺能迅速响应对任何特殊产品的需求。
本发明还提供比美国专利5163918号好的优点,当医师充装注射器然后使用它时,因先有技术的装置仅允许柱塞部分移动,这意味着在充装注射器时将不可避免地最终含有空气,而空气随之是必须除去的。这种除去空气可能会极其困难,如果不是不可能的话,将空气注射到病人体内通常会造成组织损害。本发明允许柱塞在注射器针筒内整个移动,所以在将药物抽入到注射器之前可以排出空气。然后可以将充满的注射器与安全护套结构和给病人注射的药物组合。
其他安全护套结构包括US5201720、US5271744、US5855839、US4850968和EP0966983参考的那些。
因此,本发明克服了先有技术的缺点和提供注射器用的另一种和改进的安全护套***。本发明特别的优点是,它比先有技术体积小,安全护套机构基本上较少地倾向被事故性地触发和,例如通过在注射器针筒上施加力企图迫使夹持器和护套分离时能恢复原状,安全护套机构是由柱塞杆的运动而不是施加在注射器针筒的压力致动,可以达到作为注射过程的一整体部分而不是附加的分立步骤,和在各种实施例中它的弹簧基本上不会伸展到注射器针筒上面。
按照本发明提供一种供注射器用的自动操作安全护套***,所述安全护套***包括:
内夹持器,其有近端和远端部分并限定所述注射器可以***的封闭体;
外护套,其有近端和远端部分,从所述内夹持器向外安装并相对所述内夹持器在缩回和伸展位置之间可以轴向移动;
弹簧,其定位在所述内夹持器上的第一锁销和所述外护套上的第二锁销之间,和迫使所述外护套到它的伸展位置,所述弹簧最好定位在所述内夹持器上的第一远的锁销和所述外护套上的第二远的锁销之间;
所述内夹持器有至少一个第一开口而所述外护套有至少一个第一止动件,当所述外护套处在所述缩回位置时所述第一止动件与所述第一开口接合;
所述内夹持器有与所述第一开口较远的至少一个第一缺口,当所述外护套处在所述伸展位置时所述第一止动件与所述第一缺口接合;和
触发器,其定位在所述内夹持器中并相对于所述内夹持器可轴向移动,从而当它与所述第一开口接合时它可以接触所述第一止动件,并使所述第一止动件与所述第一开口脱离接合,允许所述弹簧移动所述外护套到所述伸展位置。
普通注射器包括称为针筒的通常圆筒形部分,固定到针筒的一端的针头或其他刺穿或连接元件,可滑动地定位在针筒内的活塞或止挡件。柱塞杆一般这样与活塞接合,柱塞杆的运动引起活塞的运动。针头是可拆卸地固定到针筒上,或者它可以永久性地固定到针筒上。柱塞杆在向后拉出的伸展(最近)位置到最远(最前)位置之间可以滑动,在伸展位置针筒可以包含药物和在最远位置在针筒内排出任何药物。
自动操作安全护套***可以另外包括含有针筒、针头、活塞和在所述针筒内可移动的柱塞杆的注射器,所述柱塞杆有凸出部,所述注射器是这样可操作地连接到所述触发器上,使所述柱塞杆凸出部的移动接触所述触发器使所述第一止动件与所述第一开口脱离接合,从而允许所述弹簧将所述外护套移动到所述伸展位置。
可以按照需要将第一和第二锁销定位在内夹持器和外护套上,例如在它们的近端和远端。但是,将第一和第二锁销定位在内夹持器和外护套的远端部分是最优选的,因为这允许在所有时间内保持由外护套覆盖住弹簧,和使弹簧即使当外护套处在它的伸展位置时也不会伸展到注射器针筒之上。
在本发明的***中使用的弹簧一般是(不是必须是)螺旋弹簧,本技术领域的普通技术人员将知道本发明中可以使用的替代弹簧。普通技术人员还将知道各种螺旋弹簧,如锥形螺旋弹簧和沿着它们的长度有变化螺旋的螺旋弹簧,它们都可用于本发明中。
按照本发明提供的是一种自动操作安全护套***,其包括:
注射器,其包含针筒、针头、活塞和在所述针筒内可移动的柱塞杆,所述柱塞杆有凸出部;内夹持器,其具有近端和远端部分并限定所述注射器可***其中的封闭体;
外护套,其具有近端和远端部分,从所述内夹持器向外安装并相对所述内夹持器在缩回和伸展位置之间可以轴向移动;
弹簧,其定位在所述内夹持器上的第一远锁销和所述外护套上的第二远锁销之间,和迫使所述外护套到所述伸展位置;
所述内夹持器具有至少一个第一开口而所述外护套有至少一个第一止动件,当所述外护套处在所述缩回位置时所述第一止动件与所述第一开口接合;
所述内夹持器有与所述第一开口较远的至少一个第一缺口,当所述外护套处在所述伸展位置时所述第一止动件与所述第一缺口接合;和
所述注射器是这样可操作地连接到所述内夹持器和外护套上,所述柱塞杆凸出部相对所述内夹持器的轴向移动引起所述柱塞杆凸出部,在第一止动件与所述第一开口接合时接触所述第一止动件并使所述第一止动件与所述第一开口脱离接合,从而允许所述弹簧将所述外护套移动到所述伸展位置。
为了防止注射器柱塞杆不希望的移动,注射器可以设置固定在所述柱塞杆的从所述针筒暴露出的部分上的可拆卸的安全夹,从而当所述安全夹固定在所述柱塞杆时防止所述柱塞杆的移动。
所述外护套和内夹持器可以分别有互相成相反关系的近端和远端紧靠表面,它们可以互相接合以防止所述外护套超过它伸展位置的移动。
内夹持器和外护套可以是任何所需的形状。例如,它们可以是大体圆筒形的。圆筒的一个例子是有圆形的横截面(一般称为正圆的圆筒)。另一种是可以有椭圆的横截面。这在保证内夹持器和外护套不能在不正确的结构中放在一起,或在使用中不能互相相对转动,是特别有用的。圆筒包括那些略有锥度的,例如至少0.5度。
内夹持器和外护套也可以这样构造,提供引导装置用于它们的轴向移动以避免它们相对的转动。引导装置可以采用在内夹持器和/或外护套中的凹槽的形式。例如,第一止动件可以沿着内夹持器上的凹槽滑动。类似地,通过外护套上的凹槽可以引导外护套近端紧靠表面朝向内夹持器远端紧靠表面。
内夹持器和/或外护套每个可作为单件构成,或者可由多件构成。这样的结构对本技术领域的普通技术人员来说,将很容易明白。
本发明的所有实施例提供比先有技术好的特殊优点是,柱塞杆移动而不是如注射器针筒移动,能使弹簧将护套移动到伸展位置。一般这是柱塞杆全部被按压下和注射器的内容物已经排出如注射到病人体内的位置。或者通过柱塞杆凸出部与第一止动件直接接触,或者通过柱塞杆凸出部与第一止动件间接耦合可以达到第一止动件与第一开口脱离接合。
可以这样获得直接接触,即为柱塞杆设置拇指制动,它有轴向伸展,当压下柱塞杆时它与第一止动件接触。另一种是,柱塞杆例如可以设置拇指制动和附加的凸出部,当压下柱塞杆时凸出部与第一止动件接触。
通过可以将柱塞杆(或柱塞杆凸出部)引起的运动传递给第一止动件的任何结构,可以获得不直接的接触。该结构的精确特性将取决于柱塞杆的结构。例如,柱塞杆可以有拇指制动部,当压下柱塞杆时拇指制动部接触位于内夹持器内的一部件(如所述触发器),内夹持器依次接触第一止动件和引起它与第一开口脱离接合。第一止动件可以是可锁定地与第一锁销接合。它可以这样接合第一锁销,即防止外护套相对内夹持器的近端和远端两者的轴向运动。可以由任何其他结构或装置代替内夹持器第一锁销,例如截头圆锥体部分的陡斜面那样的凸出部件,它阻止内夹持器和外护套之间的相对运动,尽管优选的是防止任何轴向移动。
第一远的锁销可从内夹持器向外凸出,而第二远的锁销可从外护套向内凸出。
可通过任何合适的装置将注射器保持在内夹持器中。例如,为了保证注射器相对内夹持器精确的定位,注射器可以紧靠在内夹持器锁销上,例如内夹持器第一远端的突缘的上表面。为内夹持器提供注射器接合装置用于与注射器接合和保持该注射器可能也是有利的。例如,可以这样设计内夹持器和注射器,使它们成为过盈配合,一旦将注射器***到内夹持器中,只有施加很大的力,例如50N(牛顿),更特殊的至少70-80N或100N才能拆卸下来。
这样,注射器相对内夹持器是不能轴向移动的。
使用过盈配合(也称作摩擦配合)避免了需要注射器的其他保持机构,例如在内夹持器上形成截头圆锥体部分,以便将注射器保持在一定区域之内。这又意味着注射器不需任何突缘,如通常以手指夹形式设置的突缘,这允许注射器比在先有技术装置中所用的那些注射器有更小的尺寸,因此安全护套结构也更小些。当然,可能希望保留至少小的突缘,只是为了帮助在制造注射器时注射器针筒的操作,特别是在预充填注射器的情况。
本技术领域的普通技术人员将熟悉许多适合构造装置的内夹持器和外护套的材料。优选的材料是足够透明的,以便能观察***到内夹持器中的注射器的内容物或标签。合适的材料包括:聚苯乙烯、改性聚苯乙烯和聚苯乙烯共聚物、聚碳酸酯、聚醚砜、聚丙烯、环烯共聚物树脂、共聚多酯如Eastar(RTM)(树脂传递模塑)共聚多酯DN003[由对苯二酸(或对苯二酸二甲酯)、乙二醇和1,4环己基二甲醇制成的共聚多酯],和丙烯腈丁二烯苯乙烯共聚物(ABS)。特别优选的材料是Eastar(RTM)共聚多酯DN003(由Eastman Chemical Company制造)。同样有用的是MABS(异丁烯酸甲酯/丙烯腈/丁二烯/苯乙烯共聚物,牌号Terlux 2812 TR(RTM))。聚碳酸酯包括热塑聚碳酸酯(RTM)GR1210和热塑聚碳酸酯124 R-112。环烯树脂共聚物包括Topas(RTM)6013 X5。
对某些应用,可以要求在消毒状态下供应本发明的装置。本技术领域的普通技术人员将熟悉医药装置的消毒和这样装置的消毒方法如用加热、气相技术或伽玛辐射。使用在本发明的装置的结构中的材料的物理特性,在消毒时要求基本上不受消毒的影响。例如,在某些材料中消毒过程可以引入应力裂缝或材料由透明变成不透明。本发明装置消毒的优选方法是伽玛辐射。但是,伽玛辐射可能引起塑料颜色的改变以及还可能造成塑料中的应力裂缝。我们已经发现Eastar(RTM)共聚多酯DN003的伽玛辐射基本上不会产生颜色改变和基本上不会影响材料的物理特性。因此,本发明装置适合伽玛辐射消毒的优选材料是Eastar(RTM)共聚多酯DN003。
注射器针筒可以由聚丙烯构造。另一种是,注射器针筒可以分成几部段。例如它可以包括由高密度聚乙烯接合和保持透明的部段制成上和下两部分,例如包括玻璃或聚苯乙烯。下部分可与内夹持器接合。透明部段可以装有透镜以便能放大观察注射器针筒的内容。
在注射器针筒没有突缘或突缘尺寸减小的情况下,可以这样布置内夹持器,使得***的注射器针筒的作用使第一止动件和第一开口因如手指或其他小的物体***到内夹持器中造成事故性脱离接合的可能性最小,和注射器柱塞杆可以有带凸出的突缘,例如轴向凸出的环,当压下柱塞杆时该环围绕注射器针筒的外侧通过,并直接或间接地接触第一止动件使它脱离接合。
内夹持器和外护套尺寸减小(相对先有技术的护套和夹持器结构)允许装设至少一个轴向伸展的凸出部可用作手指夹,例如可用尺寸的突缘,例如围绕内夹持器的近端的整个周缘伸展至少2mm、3mm、4mm或5mm。这还允许在不会造成成核的角度下在病人身上可以***甚至大孔的针头。这是特别有用的,因为能使使用者在各种不同的位置很容易拿住内夹持器并允许手的位置改变而不会松开满意的注射所需的抓握,或者没有注射器需要的转动和由转动造成的成核。
外护套(而不是内护套)在它的近端可以没有径向伸展的凸出物,如可用作手指夹的突片或突缘。
本发明用的注射器可以供皮下注射液体、悬浮液、如微粒配方或固体药物配方(也称为长效配方)使用。这样的长效药剂注射要求注射器活塞伸展通过注射器的针孔,以确保固体药物配方已经全部排出注射器。凸出的活塞的作用可以减小针尖伤害的机会,如果由于某种理由露出针,这样通过保证压下的柱塞杆不能被拉回,使活塞保持在它的伸展位置从而可以提供有用的附加安全特性。本发明可以使用的微粒配方的例子包括醋酸亮丙瑞林微粒配方Lupron(RTM)。本发明可以使用的固体药物包括醋酸性瑞林长效配方Zoladex(RTM)。
内体可以附加地包括柱塞杆保持装置,它至少防止柱塞杆几乎在它的最前位置时所述柱塞杆的向后运动。如上所述,柱塞杆在伸展位置和最前位置之间是可滑动的。在它的最前位置柱塞杆使第一止动件与第一缺口脱离接合,通常在这个最前位置希望保持住柱塞杆,虽然也可以要求几乎到最前的某一位置保持住柱塞杆。例如,柱塞杆保持装置可以包括在内夹持器上能偏转的一个或几个部件,如截头圆锥体结构或陡斜面或所谓的防止后滑的齿,它允许压下的柱塞杆通过上(即近端)倾斜表面(通常通过使其弹性变形),但它提供的下(即远端)紧靠表面防止柱塞杆离开。
这也为本发明提供许多附加的优点。首先在本发明的各种实施例中,特别是使用如触发器将柱塞杆的运动传递到第一止动件的那些实施例,柱塞杆保持部件可以使它更加困难事故性地(或有意地)迫使第一止动件与第一缺口脱离接合,即在柱塞杆和内体之间形成的间隙中挤入手指从而击发触发器,这可以简单地通过减小间隙的尺寸获得解决。其次,如果不知为什么,在已经启用本发明的设备之后外护套是在伸展位置,对设备造成足够的机械损伤,那么尽管外护套能向后移动到它的缩进位置,第一止动件也将不能与第一缺口重新接合,因此弹簧将总是迫使外护套向后到它的伸展位置。
弹簧与内夹持器和外护套的第一及第二远锁销的结构意味着伸展的弹簧覆盖从内夹持器第一远锁销到外护套第二远锁销之间的区域,即弹簧不会伸展覆盖注射器针筒。因此,当内夹持器是由透明材料制成时,即使在外护套伸展之后仍可以察看内夹持器的内容物,这意味着在注射药物配方时在任何时候可以很容易地确认注射器的内容物是否完全排出。
弹簧不会伸展覆盖注射器针筒这一事实还提供有用的优点,即弹簧不会损伤注射器针筒,这样的损伤在先有技术中是已经认识到的一个问题,例如当使用有玻璃针筒的注射器时,常常需要使用附加的保护部件(见例如EP 0966983的第七栏19-21行)。
为了保证使用者对护套***的挤压不会阻止它工作,内夹持器可以设有手指夹区,该区包括突缘和内夹持器的刚性部段。这样的挤压将不会造成内夹持器的内部尺寸的减小,因此安全护套***将正常工作。
第一止动件可以与第一开口的紧靠表面接合。以弧形易变曲的部件从外护套伸展,即向外伸展然后伸向内的形式可以设置第一止动件。这样的结构可以允许第一止动件当与第一开口的紧靠表面接合时,它的枢转轴线的中心在接合点内部。这意味着如果某种企图无论是事故性的还是有意的想通过把它们拉开使第一止动件和第一开口脱离接合,事实上它们将互相接合得比以前更坚固,从而阻止将它们拉开。这是先有技术装置缺乏的特性,例如先有技术装置有易弯曲的止动件,它在施加足够的力之后脱开接合。
附图说明
通过下面的描述并结合附图一起将使本发明更加清楚,附图仅通过实例表示安全护套和注射器结构的一种形式。在附图中:
图1是本发明的安全护套和注射器结构的侧视图,一外护套在它的缩进位置;
图2是沿图1中的M-M线截取的剖面图;
图3是图1所示结构的侧视图,该结构已经轴向转过90°;
图4是沿图3中的N-N线截取的剖面图;
图5是内夹持器的侧视图;
图6是沿图5中的C-C线截取的剖面图;
图7是沿图5中的D-D线截取的剖面图;
图8是沿图5中的E-E线截取的剖面图;
图9是沿图5中的A-A线切开的剖视图;
图10是图5的内夹持器的侧视图,该内夹持器已经轴向转过90°;
图11是沿图10中的B-B线截取的剖面图;
图12是外护套的侧视图;
图13是沿图12中的K-K线截取的剖面图;
图14是沿图12中的H-H线切除的剖面图;
图15是图5的外护套的侧视图,该外护套已经轴向转过90°;
图15a是图15的圆形区域L的放大图;
图16是沿图15中的G-G线切除的剖视图;
图17是触发器的侧视图;
图18表沿图17中的F-F线截取的剖面图;
图19是图17所示的触发器的顶视图;
图20是安全护套和注射器结构的透视图,更详细地表示在图21、30和31中;
图21是本发明的安全护套和注射器结构部分切除的透视图,外护套在它的伸展位置;
图22是图1所示的结构在伸展位置的正视图;
图23是沿图22中的B-B线截取的剖面图;
图24是图1所示的结构在伸展位置的侧视图;
图25是沿图24中的C-C线截取的剖面图;
图26是第二安全护套和注射器结构在安全护套伸展之前的正视图;
图27是沿图26中的C-C线截取的剖面图;
图28是图26的结构的侧视图;
图29是沿图28中的B-B线截取的剖面图;
图30是通过本发明的另一实施例的剖面图,它基本等同于图25中表示的结构;和
图31是通过图30的结构的另一剖面图,基本等同于图4中所示的结构。
具体实施方式实例1
在第一实施例中,本发明的安全护套和注射器结构10包括内夹持器20、外护套30、金属螺旋弹簧40、触发器50和注射器60。
内夹持器20是由Eastar(RTM)共聚多酯DN003(EastmanChemical Company公司制造)构造,且是细长的一般圆柱形,限定封闭体70并具有内夹持器近端部分80和内夹持器远端部分90以及限定端部开口的端100、110。近端部分80朝端部100变宽形成嘴111,在使用中使用者的手夹住嘴111。嘴111基本上是刚性的,所以使用者所施加的压力不会减小它的直径和阻碍安全护套结构10的操作和外护套30的伸展。嘴111有径向朝外伸展的突缘120,在使用中它作为手指夹,允许使用者容易操作结构10。位于嘴111的远端的是两个互相径向相反的第一开口130,并有远端表面,该远端表面由提供上贴靠表面150和下倾斜表面160的两个第一截头圆锥体部分140限定。从第一截头圆锥体部分140轴向朝远端伸展的是第一凹槽145。位于远端部分90中的,在第一开口130的轴向远处是两个第一缺口170,它有两个可弯曲的舌部180,从近到远端方向伸展进入到缺口中。舌部180的远端181从近端182径向朝外伸展。
两个第二凹槽185从第一开口130、第一截头圆锥体部分140和第一缺口170轴向转动90°和向远处伸展。位于远端部分90中的是两个锁销,它们包括两个向外伸展的第二截头圆锥体部分190,有上紧靠表面200和下倾斜表面210。第二截头圆锥体部分190径向朝内的是径向朝内伸展的环220(见下面),它与注射器60接合。环220的轴向远端是径向朝内伸展的远端突缘230,它有上和下紧靠表面231、232。
也由Eastar共聚多酯DN003构造的外护套30,其形状与内夹持器20的形状相匹配,从而它在内夹持器20上轴向可滑动。外护套30有近端和远端部分240、250以及近和远端260、270。近端260设有两个径向相对的向内伸展的突缘,突缘提供紧靠表面280,该表面有轴向伸展的倾斜侧壁290。紧靠表面280和侧壁290的形状是这样,它们能紧配合覆盖第二截头圆锥体部分190。近端260还设有两个止动件300由紧靠表面280轴向转动90°。止动件300包括可弯曲的臂310,它通常有两侧对称的不规则四边形的外周边形状和头部320。臂310的远端向内伸展并可轴向移动,壁310向外伸展。臂310的近端的头部320向内伸展并提供近的紧靠表面330。远端270设有整体环形凸出部340,它提供倾斜的紧靠表面350,在其轴向远处伸展第二远的锁销370,该锁销有远的紧靠表面360。
触发器50大体上是圆筒形,其有近和远端380、390并设计成可装配到内夹持器20的嘴111中,因此它可在嘴111内轴向滑动。远端390有向内弯曲的颈400。
注射器60包括有固体药物配方(未表示)的大体圆筒形的针筒410,在它的近端有突缘420而在它的远端有针头430和可拆卸的针罩431。将活塞440可滑动地定位在针筒410中。柱塞杆450在一端与活塞440接合而在另一端有提供拇指压钮460的突缘。安全夹470可拆卸地固定在柱塞杆450的从针筒410暴露出的部分上,防止柱塞杆450的移动。
安全护套和注射器结构是首先将金属螺旋弹簧40放在外护套30中,使弹簧接触远端突缘370的紧靠表面360而开始构造。接着夹住内夹持器20的端部110并使它在外护套的近端260内滑动和滑向远端270。当止动件300的臂310和头部320在截头圆锥体部分140的倾斜表面160上通过时使它们向外偏转,直到它们已经滑过截头圆锥体部分140,在这一点它们向内卡住,使紧靠表面150、330彼此相对。接触外护套30的倾斜紧靠表面350的端部110防止内夹持器20的进一步滑动。内夹持器20在外护套30内的滑动将弹簧40被压缩在外护套30的紧靠表面360和内夹持器20的下紧靠表面232之间。松开对内夹持器20的抓握允许弹簧40略为弹起,推动分开内夹持器20和外护套30,并使相对的紧靠表面150、330互相接合和防止内夹持器20和外护套30进一步的相对运动。外护套现在接合在缩回位置。
止动件300的壁310和头部320的结构是这样,使臂310的框转轴线的中心在紧靠表面150、330的接触区的径向朝内处。与先有技术相反,可以通过加上足够大的力使先有技术的夹持器和护套部分脱离接合,而本装置企图将内夹持器20和外护套30拉开(即脱离接合)的努力将造成止动件300与内夹持器20接合得更紧。
然后将触发器50滑动进入内夹持器20的嘴111中使得颈400接触头部320。
接着***注射器60,首先是将针头430***到内夹持器20的嘴111中并朝端部110滑动使得针头430和针罩431从端部110突出。当针筒410接触远端突缘230的上紧靠表面231时停止***。注射器60的针筒410的近和远端由高密度聚乙烯制成并与环220形成过盈配合使得它在没有施加很大的力时不能从内夹持器20很容易地取下。突缘420防止触发器50从嘴111中移出,但也没有对触发器50施加任何的力和不会引起触发器50移动,而这种移动可能造成内夹持器20和外护套30脱离接合。
使用中,从柱塞杆450上除去安全夹470,还除去针罩431。将针头430***到病人(未表示)体内和压下拇指压钮460使活塞440滑动通过针筒410和以针头430中排出固体药物配方(未表示)和使活塞440从针头430伸展。同时(即不是分离的步骤部分),拇指压钮460进入到嘴111中和接触触发器50,使它轴向移动。头部320妨碍触发器50的这种轴向移动,但当触发器50轴向移动时弯曲的颈部400使头部320向外偏转。触发器50的足够的轴向移动和因此头部320的向外运动使相反的紧靠表面150、330脱离接合,允许外护套30的轴向移动。弹簧40推动内夹持器20和外护套30分离,当针头430从病人480身上拔出时使外护套30在内夹持器20上滑过,覆盖针头430和防止任何可能的针尖伤害。在滑动阶段,分别由凹槽145、185引导止动件300的头部320和第二截头圆锥体部分190,防止内夹持器20和外护套30互相之间的相对转动。当针头430完全从病人480身上拔出时,头部320在倾斜的舌部180上通过并快速卡合在第一缺口170中,防止内夹持器20和外护套30的进一步轴向移动。同时紧靠表面280和侧壁290以紧密配合在第二截头圆锥体部分190上滑动,紧靠表面280接触上紧靠表面200,并作为附加的安全措施防止任何进一步伸展。现在外护套锁定在伸展位置。本发明安全护套和注射器结构10的整个操作,一个人可用单手很容易地完成。实例2
第二实施例同实例1,除了注射器针筒410没有突缘420,和触发器50不是保持在嘴111中,相反由拇指压钮460的轴向延伸部600代替。这种结构使得在将注射器60放在内夹持器20中时造成相对的紧靠表面150、330的事故性脱离接合,或其他靠成相对的紧靠表面150、330脱离接合的可能性减至最小。没有突缘420,还可以减小嘴111的直径,从而或者减小内夹持器20的整个尺寸或者到伸展突缘120的尺寸,以便允许进一步改进使用者的抓握。实例3
第三实施例与实例1相同,除了嘴111设有可弯曲的截头圆锥体部分500(未表示),它有上(近)倾斜表面501(未表示)和基本与内夹持器的轴线垂直的下(远)紧靠表面502(未表示)。使用中,当拇指压钮460进入嘴111时(从针430排出固体药物处方和活塞440从针头430伸展),它使截头圆锥部分500偏转并通过超出它们,在这一点它们回复到它们原来的形状和呈现出与拇指压钮460相反的紧靠表面502,防止它离开嘴111。这意味着活塞440锁定在从针430伸展的位置,从而即使外护套30被除去或损坏而暴露出针头430,针尖仍基本上受到保护。实例4
有改变尺寸(通常比其他图中表示的要窄)的另一个实施例表示在图30、31、20和21中。特别是,内夹持器20的长度为约为68mm,它被外护套30覆盖的近端部分的直径约为10mm,并有变窄的突缘120。值得注意的是,外护套30是两部件结构。
触发器50还设有围绕它的整个周缘径向朝外伸展的第一和第二弧形的凸出部600、610,触发器50(和/或嘴111)是有足够弹性变形的,以便可迫使它们通过相应的第三弧形的凸出部620,该第三凸出部是围绕嘴111的整个周缘径向朝内伸展。当构造本发明的装置时,将触发器50***到内夹持器20的嘴111中和使第一弧形凸出部600紧靠第三弧形凸部620。对触发器50可很容易地施加足够的向下力使它弹性变形,以便允许第一弧形凸出部600在第三弧形凸出部620上通过。当将触发器50继续向下压时,第二弧形凸出部610紧靠第三弧形凸出部620。接着对触发器50施加足够的向下力使它弹性变形,以便允许第二弧形凸出部610在第三弧形凸出部620上通过。如图30和31所示将触发器50全部***。虽然可以很容易对触发器50施加向下的力将它***到嘴111中,但一旦***由人施加足够的向上力要将触发器50从嘴50中取出就会极其困难,因此可以认为触发器将永久地位于嘴111之中。
用这种触发器50的两级***,本发明的装置可在这样的状态下储存和装运,即将内夹持器20、外护套30和弹簧40互相接合在一起和将触发器50***到内夹持器20的嘴111中,使第三弧形凸出部位于第一和第二弧形凸出部600和610之间。可以将注射器60***到嘴111中并与内夹持器20接合而不与触发器50接触。既使在***注射器60时事故性地接触触发器50,由于第二弧形凸出部阻碍它移动超过第三弧形凸出部620,从而防止止动件300与第一开口130脱离接合。当注射器60已经全部***时,接着对触发器50可以施加足够的力推动第二弧形凸出部610通过第三弧形凸出部620。现在注射器装置10已作好使用的准备。
取决于嘴111和拇指压钮460的结构和可变形性,以及拇指压钮460的尺寸,可以使用围绕嘴111的整个周缘径向朝内伸展的凸出部,以便防止拇指压钮460从嘴111脱离。
Claims (18)
1.一种注射器用的自动操作安全护套***,所述安全护套***包括:
内夹持器,它有近端和远端部分并限定所述注射器可以***的封闭体;
外护套,它有近端和远端部分,从所述内夹持器向外安装并相对所述内夹持器在缩回和伸展位置之间可以轴向移动;
弹簧,它定位在所述内夹持器上的第一锁销和所述外护套上的第二锁销之间,和迫使所述外护套到它们伸展位置;
所述内夹持器具有至少一个第一开口而所述外护套具有至少一个第一止动件,当所述外护套处在所述缩回位置时所述第一止动件与所述第一开口接合;
所述内夹持器有与所述第一开口较远的至少一个第一缺口,当所述外护套处在所述伸展位置时所述第一止动件与所述第一缺口接合;和
触发器,它定位在所述内夹持器中并相对所述内夹持器可轴向移动,从而当它与所述第一开口接合时它可以接触所述第一止动件,并使所述第一止动件与所述第一开口脱离接合,允许所述弹簧移动所述外护套到所述伸展位置。
2.如权利要求1所述的自动操作安全护套***,所述第一和第二锁销分别定位在所述内夹持器和外护套的所述远端部分上。
3.如权利要求1或2所述的自动操作安全护套***,其另外包括有针筒、针头、活塞和在所述针筒内可移动的柱塞杆的注射器,所述柱塞杆有凸出部,所述注射器是这样可操作地连接到所述触发器,使所述柱塞杆凸出部的移动接触所述触发器,造成所述第一止动件与所述第一开口脱离接合,从而允许所述弹簧将所述外护套移动到所述伸展位置。
4.一种自动操作安全护套***,其包括:
注射器,它包含有针筒、针头、活塞和在所述针筒内可移动的柱塞杆,所述柱塞杆有凸出部;
内夹持器,它有近端和远端部分并限定所述注射器可***其中的封闭体;
外护套,它有近端和远端部分,从所述内夹持器向外安装并相对所述内夹持器在缩回和伸展位置之间可以轴向移动;
弹簧,它定位在所述内夹持器上的第一远锁销和所述外护套上的第二远锁销之间,和迫使所述外护套到所述伸展位置;
所述内夹持器有至少一个第一开口而所述外护套有至少一个第一止动件,当所述外护套处在所述缩回位置时所述第一止动件与所述第一开口接合;
所述内夹持器有与所述第一开口较远的至少一个第一缺口,当所述外护套处在所述伸展位置时所述第一止动件与所述第一缺口接合;和
所述注射器是这样可操作地连接到所述内夹持器和外护套上,使所述柱塞杆凸出部相对所述内夹持器的轴向移动引起所述柱塞杆凸出部在第一止动件与所述第一开口接合时接触所述第一止动件,并使所述第一止动件与所述第一开口脱离接合,从而允许所述弹簧将所述外护套移动到所述伸展位置。
5.如权利要求3或4任何一项所述的自动操作安全护套***,所述注射器设有安全夹,其可拆卸地固定在所述柱塞杆从所述针筒暴露出的部分上,从而当所述安全夹固定在所述柱塞杆上时防止所述柱塞杆移动。
6.如前述权利要求中任一项所述的自动操作安全护套***,所述外护套和内夹持器分别有彼此成相对关系的近端和远端紧靠表面,它们可以彼此接合以防止所述外护套移动超出它的伸展位置。
7.如前述权利要求中任一项所述的自动操作安全护套***,所述内夹持器和外护套总体上是圆筒形并有从包括圆形和椭圆形的一组图案中所选择的横截面。
8.如权利要求7所述的自动操作安全护套***,所述总体上的圆筒形是锥形的圆筒形。
9.如前述权利要求中任一项所述的自动操作安全护套***,所述内夹持器和外护套中的至少一个有轴向移动的引导装置,以防止所述内夹持器和外护套的相对转动。
10.如权利要求9所述的自动操作安全护套***,所述内夹持器有对应于所述第一止动件的凹槽,沿着该凹槽所述第一止动件可以滑动。
11.当根据权利要求6时按照权利要求9或10中任一项所述的自动操作安全护套***,所述外护套有对应于每个所述远端的紧靠表面的凹槽,沿着该凹槽所述远端的紧靠表面可以滑动。
12.如前述权利要求中任一项所述的自动操作安全护套***,所述内夹持器有内夹持器锁销,该锁销包括径向朝内伸展的远端突缘,该突缘有与所述注射器接触的上紧靠表面,防止所述注射器在所述内夹持器中进一步朝远处移动。
13.如前述权利要求中任一项所述的自动操作安全护套***,所述内夹持器有注射器接合装置,用于接合并保持所述注射器。
14.如前述权利要求中任一项所述的自动操作安全护套***,所述内夹持器在它的近端有至少一个径向伸展的凸出部,可用作手指夹。
15.如权利要求14所述的自动操作安全护套***,在所述内夹持器近端的所述至少一个径向伸展的凸出部是围绕所述内夹持器的整个周缘伸展的突缘。
16.如前述权利要求中任一项所述的自动操作安全护套***,所述外护套在它的近端没有可用作手指夹的任何径向伸展的凸出部。
17.如前述权利要求中任一项所述的自动操作安全护套***,所述内夹持器另外包括柱塞杆保持装置,当所述柱塞杆至少几乎在它的最前位置时防止它向后移动。
18.如前述权利要求中任一项所述的自动操作安全护套***,所述第一止动件首先从所述外护套向外接着向内伸展,使得所述第一止动件当与所述第一开口接合时,它的枢转轴线的中心在与所述第一开口接合点的内部。
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- 2001-02-13 MX MXPA02007974A patent/MXPA02007974A/es active IP Right Grant
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- 2001-02-13 CZ CZ20022829A patent/CZ302410B6/cs not_active IP Right Cessation
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- 2001-02-13 JP JP2001559529A patent/JP4208466B2/ja not_active Expired - Lifetime
- 2001-02-15 CO CO01012098A patent/CO5261569A1/es active IP Right Grant
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CN109689129A (zh) * | 2016-09-16 | 2019-04-26 | 拜耳医药保健有限公司 | 具有针筒保持元件的压力护套 |
CN113018589A (zh) * | 2021-02-06 | 2021-06-25 | 焦作市妇幼保健院(焦作市妇女儿童医院) | 一种防刺伤一次性注射器 |
CN113018589B (zh) * | 2021-02-06 | 2024-02-06 | 焦作市妇幼保健院(焦作市妇女儿童医院) | 一种防刺伤一次性注射器 |
CN117771475A (zh) * | 2024-02-27 | 2024-03-29 | 山东永聚医药科技股份有限公司 | 固体制剂用植入式预灌封注射器及其制备方法 |
CN117771475B (zh) * | 2024-02-27 | 2024-05-10 | 山东永聚医药科技股份有限公司 | 固体制剂用植入式预灌封注射器及其制备方法 |
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