CN1094767C - 带上盖的塑料注射器 - Google Patents
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Abstract
本发明涉及一种塑料预灌装注射器,特别适用于使用不带注射针头的预灌装针筒如将药液由针筒导入静脉滴注的情况。该注射器包括:一在一端通过一可移动塞头密封而另一端通过一与所述注射器脆弱连接的尾塞密封的开端圆筒;以及一上盖;所述上盖包括适于至少固定和保持所述尾塞端部的尾塞保持装置;所述上盖可以从一第一位置移动至一第二位置,当在第一位置上时,将所述上盖从第一位置去除不会导致所述尾塞与所述注射器之间的脆弱连接部断裂,当在第二位置时,尾塞由尾塞保持装置固定和保持,并且将上盖从第二位置去除会导致尾塞与注射器的其余部分分开,从而显露注射液供注射用。
Description
本发明涉及一种注射器,特别涉及一种适于用作一预灌装产品的塑料注射器。
背景技术
近年来,由于对于特别是在处理大量病人时各种传染病毒如艾滋-人免疫缺陷病毒(AIDS-HIV)和肝炎的转移风险了解增多,在医学实践中已出现一些重大变化。特别是医务人员对因外科器械和其他医用器械的重复使用带来的病毒转移的风险提高了警惕。由于这个和其他一些原因,安全、方便地使用一次性使用的外科器械和其他医用器械的要求更为增加。而在皮下注射器方面则尤为如此。由于皮下注射针头与体液接触,因此,如果同一针筒使用一次以上,则就存在交叉感染的风险,即使注射针头每次使用后实际上是处理掉的。正是由于这一理由及其他一些理由而需要预灌装一次性注射器。一种已精确灌装并贴上注射液名称标签的单剂量产品由于可降低用法方面不正确剂量的风险,故对使用来说不仅方便,而且更为安全。它用过一次即丢弃。无需对设备进行重新消毒,也无需从分离的针剂瓶中对注射液进行仔细转移。
申请人在澳大利亚专利595096中描述了一预灌装注射器的一个例子。该专利中所描述的注射器是一端通过一塞头密封而另一端则通过一与注射器一体的尾塞密封。该尾塞适于被卸下以便卸下后可将一皮下注射针头固定到针筒端部进行注射。尾塞被描述为可通过用一适当形状的工具扭转或通过扣闩动作卸下。
申请人在澳大利亚专利635631中描述了一预灌装注射器的一个进一步的例子,其中所描述的针筒也装有一体式尾塞。在将注射针头装到针筒上的针头连接装置上时尾塞从针筒端部破裂。尾塞进入针筒并保持在针筒针头端的室内。
尽管前述两种产品相对于其它现有技术的预灌装针筒作了重要改进,本发明涉及针筒设计的一种变型,它在一些应用中相对于前述两种产品具有某些优点,这从以下的具体描述中将显而易见。
发明概述
本发明涉及使用一种可用来卸下一预灌装针筒上的一体尾塞的保护性上盖。本发明特别用于与澳大利亚专利635631中描述和限定的那种类型的针筒,但不限于那种针筒。它特别适用于使用不带注射针头的预灌装针筒如将药液由针筒导入静脉滴注的情况。
因此,本发明提供一种塑料预灌装注射器,包括:(a)一在一端通过一可移动塞头密封而另一端通过一与所述注射器脆弱连接的尾塞密封的开端圆筒;以及(b)一上盖,所述上盖包括适于至少固定和保持所述尾塞端部的尾塞保持装置;其中,所述上盖可以从一第一位置移动至一第二位置,当在第一位置上时,将所述上盖从第一位置去除不会导致所述尾塞与所述注射器之间的脆弱连接部断裂,当在第二位置时,尾塞由尾塞保持装置固定和保持,并且将上盖从第二位置去除会导致尾塞与注射器的其余部分分开,从而显露注射液供注射用。
所述尾塞的形状较佳地为一从所述针筒端远离塞头端向外延伸的杆,而所述尾塞保持装置为其内可插入所述杆的上盖中的一中空沟槽。在本实施例中,能以许多方式将所述尾塞固定和保持在所述尾塞保持装置内,这对熟悉本领域的人员来说是显而易见的。例如,所述杆或小孔可包括与另一方的凹槽相配合的凸条之类,使当所述杆被推到进入沟槽足够远时将“锁”入所述上盖。一个施加在上盖上的适当的卸下力将引起尾塞对于针筒密封的破裂,使得上盖和尾塞会以一个动作予以卸下。最佳是中空沟槽包括一略带内锥度的部分,从而在直径方面逐步变窄。
在这一实施例中,可对上盖施加一向下力使上盖向下移动并在施加将上盖(和尾塞)从注射器端部卸下的卸下力前迫使尾塞端紧密地进入所述沟槽。这里所述尾塞保持装置为中空沟槽而所述尾塞为一外伸杆,所述杆的最大横截面较佳地在1.5毫米至2.3毫米之间。其最佳的最大横截面在1.8毫米至2.1毫米之间。所述沟槽较佳为包括一其最大横截面至少比所述杆小0.1毫米的保持部。在此实施例中,可取的是所述沟槽的入口比所述杆至少宽0.1毫米,且所述沟槽包括一锥度在1-3°之间(最佳为1.5°)的纵向圆锥部分。另一方法是,所述沟槽的横截面直径可以基本一致而所述杆可为圆锥形。
在这些配置中,尾塞的端部可包括多个纵向沟槽或凹槽并由一可压缩而有弹性的塑料制成。由于这种形式,故尾塞包括多个在受迫进入上盖中沟槽时更易于压缩的翅片。这提高了尾塞在沟槽中用以从所述注射器端部卸下保持性。
在本发明的一个实施例中,注射器的尾塞端包括一简单的出口小孔,一旦尾塞卸下,注射器的药液即可通过该小孔被挤出。在另一实施例中,注射器的尾塞端包括一适于容置支承在一塑料支架上的注射针头的连接装置。例如,注射器端部处的连接装置可以采取由一外周壁围绕并与之间隔的一中空圆锥部。该外周壁的内表面可以包括一例如在一标准的“路厄锁紧”针头连接装置中那样的螺纹。在此实施例中,尾塞密封地连接到针头连接装置的圆锥部并凸出在该连接装置外面。较佳为该尾塞也向内延伸到中空圆锥部并在一与尾塞内壁一定距离位置处脆弱地连接到圆锥部内壁。
如果上盖已被去除,较佳地是,尾塞对注射端部的连接应有足够的强度以承受注射器的意外碰撞或跌落,但一旦尾塞的远端仍保留在上盖上的尾塞保持装置中时,又脆弱到由于去除上盖而产生的去除力而破裂的程度。在挤压上盖沟槽中尾塞的较佳实施例中,沟槽中的杆的摩擦力应大于使尾塞与注射器端部之间的脆弱连接破裂所需的力。
尾塞与注射器端部的连接装置较佳为通过一塑料过桥部提供,该过桥部从注射器端部处的一出口小孔的内壁向尾塞的外壁延伸。最佳为该过桥部包括一最小横截面部分和一另一离开最小横截面部分厚度均匀增加的部分。较理想的是最小横截面部分即为最靠近尾塞外壁的过桥部。
上盖的尺寸和形状应覆盖和保护尾塞不受意外滥用。理想的是该上盖在其端部应包括一抓取部以便于去除,例如一摄手或向外延伸的凸缘。较佳为将上盖固定到尾塞上方的位置。这通过将上盖点焊在注射器端部可以很容易地予以实现。在注射器端部包括一“路厄锁紧”或类似形式的针头连接装置的本发明实施例中,上盖较佳为具有一相应的裙边,其直径和厚度可配装在中空圆锥部与针头连接装置的外周壁之间。另外可行的是,在认为需保护外周壁的外表面不被污染的情况下,该上盖可包括一相应的裙边,其直径可套在外周壁的外表面上。如果需要更高的操作精度,则上盖可有两个相隔稍大于外周壁厚度的距离的并定位以装在外周壁的任一侧的相应裙边部。较佳是通过将裙边的外表面点焊在外周壁内表面而将上盖固定在位置上。
较佳是将上盖固定到罩住尾塞的位置且使尾塞端部在入口处但不在尾塞保持装置中接合。在本发明的一个实施例中,上盖有一个相应的裙边,该裙边设置成装在圆锥部与路厄锁紧连接装置的外周壁之间并包括一脆弱地连接到相应裙边上端的外环。当上盖位于盖住尾塞而尾塞端部在入口处但不在尾塞保持装置内接合的位置时,外环位于靠在外周壁顶部处。通过这种方式,可以用容易的两步动作来打开注射器,首先将上盖推入(从上盖折断脆弱环并使尾塞的端部接合入尾塞保持装置中)并拉出(去除上盖和尾塞并显露注射器药液供注射)。
在采用一路厄锁紧但相应的裙边与外周壁点焊的另一实施例中,可以采用一三步动作打开注射器,首先将上盖扭转(折断与注射器端部的密封),推入(使尾塞的端部接合入尾塞保持装置中)并拉出(去除上盖和尾塞并显露注射器药液供注射)。
在这个实施例中,注射器体和上盖可有用地含有一种在上盖与外周壁焊接处相互偏置的相互协同的齿和凹槽结构。例如可将一对齿模制到外周壁的相对两侧而上盖可装设相配的凹槽,当上盖被焊接到位时该凹槽与外周壁上的相应齿偏置。如果将齿成形至在位于该位置时紧靠在外周壁的底端,则由于上盖不能被推入,故这种相互作用可防止尾塞在上盖中意外接合。然而,当操作者想打开注射器使用时,可扭转上盖以折断与注射器端部的密封,然后可对准联动齿和凹槽使操作者可将上盖推入而与尾塞保持装置中尾塞的端部接合。
可以采用澳大利亚专利635631中描述和限定的注射器与前述具有所需特点的上盖相结合产生一种本发明的合成产品。在该种注射器方面用户有两种选择,即通过上盖去除尾塞或一旦上盖已被去除则通过装设一注射器折断尾塞连接(如果上盖尚未用来去除尾塞的话)。由于可容易地将同一产品与静脉滴注装置(不带注射器)的一部分相连接或作为以两种方式之一简单有效注射器开口的注射器,这样就在使用方面给予用户以灵活性。
本发明的注射器较佳为由一弹性材料如聚丙烯、聚乙烯或聚乙烯对酞酸盐制成。最佳为由聚乙烯经注塑模制成。
本发明的任何前述实施例均可部分或全部在无菌环境下制作以保证注射器药液无菌。
注射器圆筒和上盖较佳为在无菌环境下分开进行注塑模。然后在注射器中灌装预先消毒的注射液。一旦灌装完毕即在预先消毒条件下将一塞头送至无菌环境并插入该注射器圆筒的打开端。
将盖插在尾塞端部上方,并且较佳为与圆筒的尾塞端焊接(例如通过超声波焊接)。所有这些步骤较佳为均在无菌环境下进行。在一较佳工艺过程中,其后离开消毒区域的注射器被加载后卸载以供最终消毒。然后较佳为将注射器送至一柱塞杆和插入机。在此阶段,如果希望的话,可移去完成的预灌装注射器并放在一最终消毒装置上。该工艺过程可进一步扩展,以使柱塞杆插入、标签和检查也在消毒区域进行。
因此,按照本发明的另一个方面,提供一种塑料预灌装注射器,包括:(a)一在一端通过一可移动塞头密封而另一端通过一与所述注射器脆弱连接的尾塞密封的开端圆筒;以及(b)一上盖;所述上盖包括适于至少固定和保持所述尾塞端部的尾塞保持装置;所述上盖可以从一第一位置移动至一第二位置,当在第一位置上时,将所述上盖去除不会导致所述尾塞与所述注射器之间的脆弱连接部断裂,当在第二位置时,尾塞由尾塞保持装置固定和保持,并且将上盖从第二位置去除会导致尾塞与注射器的其余部分分开,从而显露注射液供注射用。
以下参照附图说明本发明的较佳实施例,其中:
图1为带有上盖的本发明注射器的横剖面图,上盖在与尾塞接合之前与注射器端部连接;
图2为图1所示注射器的横剖面图,带有被压入的上盖和被保持在上盖内的尾塞;
图3为上盖的一放大横剖面图;
图4为图3所示上盖的一横剖面图,该上盖刚从其内保持有尾塞的注射器其余部分移去;
图5为注射器针头连接装置的一放大剖面图,表示尾塞移去前的连接情况;
图6为本发明又一实施例的一横剖面图,表示一具有模制齿的注射器,该模制齿被成形和定位至与形成在上盖中的凹槽协同。本图示出了尾塞在上盖中接合并保持前的上盖位置;以及
图7为图8所示注射器的一横剖面图,其中上盖转动并压入使注射器上的齿和上盖上的凹槽接合,而尾塞则保持在上盖中。
如图1所示,注射器1包括一具有开口端的圆筒2。该圆筒2由一可移动塞头3在一端密封并通过一尾塞4在另一端密封。该尾塞4实际上是一连接到注射器1的针头连接装置5的杆。一上盖6盖住尾塞4并连在注射器的针头连接装置5上。上盖6包括一防止上盖6朝下运动的脆弱连接环6a。连接环6a通过脆弱过桥6b与上盖6的外壁连接并紧靠在注射器的针头连接装置5的端部。上盖6也包括一中空沟槽7。
上盖6用点焊与注射器端部连接。
针头连接装置5实际上是一个路厄锁紧装置,其具体结构如图5所示。针头连接装置5具体包括一由一外周壁9围绕的中空圆锥部8。尾塞4通过一脆弱过桥部10连在圆锥部8中。过桥部10包括一最小截面部11和一与圆锥部8的内壁相连的增厚部12。申请人发现如果过桥部设计成这种形式,则当尾塞4移去时会促进干净而一致的折断。尾塞4较佳地包括圆锥形的端部13。圆锥部8的内壁也包括制成一定尺寸的止挡部14以便如果通过将尾塞沿箭头15方向向下推以可打开注射器时防止尾塞4落入注射器体内。
由图4可见,尾塞4包括由各翅片17分隔的槽16。
图1表示上盖6,该上盖6盖住尾塞4并通过将上盖6的外壁18与外周壁9的内表面19点焊而与针头连接装置5连接。尾塞4的端部位于邻近沟槽7的开口处。
使用时,转动上盖6以折断与针头连接装置5的连接。然后沿箭头21方向推入,使环6a与上盖6分离而尾塞4则被推入并保持在沟槽7内。由于沟槽7从开口20起呈约1.5度的内锥度,直径逐步减小,故尾塞4被紧密固定在沟槽中。
一旦尾塞4已随同上盖6被保持,即沿箭头22的方向向外拉带着尾塞的上盖,如图4所示。通过过桥部10的最小横截面部的折断尾塞脱离针头连接装置5的圆锥部8。移去尾塞有效地打开了注射器,从而容置在圆筒中的注射液可供注射用。可在针头连接装置5上装设一注射针头(未示)或将注射器连在一适当的通道用来将注射液导入滴注管或类似用途。
图6所示为本发明的又一实施例。注射器的针头连接装置5与图1所示的相似。相似的特征与图1和2所示实施例的叙述采用同样的标号。在此注射器中,上盖较宽,其外壁18则被配置为位于外周壁9的外侧。上盖6的外壁18设有两条凹槽23、24,如图7所示。针头连接装置5含有两个齿25、26,当上盖6处在尾塞4邻近沟槽7的入口的位置上时齿25、26具有靠在或邻近外壁18的端壁27所需的长度。在图6所示的结构中,凹槽23、24与齿25、26偏置。在图6所示的实施例中,上盖6采用点焊以在图6所示的方向上与注射器1连接。使用时,操作者扭转上盖6以折断点焊而使上盖6能被移动。将上盖6转动到凹槽23、24与齿25、26对准的位置。然后在该位置上沿箭头21方向将上盖6推到如图7所示的位置。正如图1和2所示的实施例一样,沿箭头22方向的移去力将导致尾塞4被移去,从而显露注射器的注射液供注射用。在图6和7所示的实施例中,注射器1的相对端被设计成可减少未经批准的乱搞和药液从注射器移出的可能性。塞头3连于柱塞杆28而柱塞组件则穿过开端29延伸。在所示的配置中,开端由一包含一从圆筒2的内壁向内延伸的自由端31的颈环30限定。与腔孔相比开口29以这种方式收缩。柱塞组件则穿过开口29延伸。一支撑盘32从邻近塞头3的柱塞杆28向外延伸。与盘32间隔又设有一盘33。盘32、33和环30相结合进行工作以防止注射液从注射器体未经批准的渗出。
应当理解,本发明各较佳实施例的前述各实例为用户提供了显著的灵活性。通过上盖中的保持装置或一旦在移出上盖后将一注射针头设置到针头连接装置上,可以将尾塞移出。注射器可以预先灌装被标志和已知数量的特定的注射液,这为医务工作者提供了方便和使用上的舒适。
应当理解,对于前述各较佳实施例可以进行增补和/或变更,但均不脱离由下述权利要求消毒的本发明的范围内。
Claims (17)
1.一种塑料预灌装注射器(1),包括:
(a)一在一端通过一可移动塞头(3)密封而另一端通过一与所述注射器脆弱连接的尾塞(4)密封的开端圆筒(2);以及
(b)一上盖(6),所述上盖包括适于至少固定和保持所述尾塞(4)端部的尾塞保持装置(7);
其特征在于,所述上盖(6)可以从一第一位置移动至一第二位置,当在第一位置上时,将所述上盖(6)从第一位置去除不会导致所述尾塞(4)与所述注射器之间的脆弱连接部(10)断裂,当在第二位置时,尾塞(4)由尾塞保持装置(7)固定和保持,并且将上盖(6)从第二位置去除会导致尾塞(4)与注射器的其余部分分开,从而显露注射液供注射用。
2.如权利要求1所述的塑料注射器,其特征在于,所述尾塞(4)为一从所述注射器(1)的远离塞头(3)端向外延伸的杆的形式。
3.如权利要求2所述的塑料注射器,其特征在于,所述尾塞保持装置为上盖(6)中一个其内可插入所述杆的中空沟槽(7)。
4.如权利要求3所述的塑料注射器,其特征在于,所述中空沟槽(7)包括一内部锥度部分,使得它在直径方面逐步变窄。
5.如权利要求3或4所述的塑料注射器,其特征在于,所述杆(4)的最大横截面为1.5毫米至2.3毫米,所述上盖(6)中的中空沟槽(7)包括一最大横截面至少比所述杆(6)小0.1毫米的部分。
6.如权利要求5所述的塑料注射器,其特征在于,所述杆(4)的最大横截面为1.8毫米至2.1毫米。
7.如权利要求1-4中任一项所述的塑料注射器,其特征在于,所述尾塞包括多个纵向沟槽(16),每个纵向沟槽由一可压缩翅片(17)分开。
8.如权利要求1-4中任一项所述的塑料注射器,其特征在于,所述注射器的尾塞端包括一适于容置一注射针头的连接装置(5)。
9.如权利要求8所述的塑料注射器,其特征在于,所述连接装置(5)为一路厄锁紧针头连接装置,它包括一中空圆锥部(8)和一外周壁(9)。
10.如权利要求1-4中任一项所述的塑料注射器,其特征在于,所述尾塞(4)通过一塑料过桥部(10)与注射器端部连接,所述过桥部从注射器端部处的一出口小孔的内壁向尾塞(4)的外壁延伸。
11.如权利要求10所述的塑料注射器,其特征在于,所述过桥部(10)包括一最小横截面部分(11)和一另一离开最小横截面部分厚度均匀增加的部分。
12.如权利要求1-4中任一项所述的塑料注射器,其特征在于,所述上盖(6)被固定到盖住尾塞(4)的位置。
13.如权利要求9所述的塑料注射器,其特征在于,所述上盖(6)包括一相应的裙边,其直径和厚度为可配装在中空圆锥部(8)与针头连接装置(5)的外周壁(9)之间。
14.如权利要求9所述的塑料注射器,其特征在于,所述上盖包括一相应的裙边(18),其直径为可套在针头连接装置的外周壁(9)的外侧。
15.如权利要求1-4中任一项所述的塑料注射器,其特征在于,所述注射器(1)仅由聚丙烯、聚乙烯或聚乙烯对酞酸盐制成。
16.一种制造塑料预灌装注射器的方法,包括:
i)在无菌环境下,对一打开端圆筒(2)进行注塑模制,所述圆筒通过一一体式尾塞(4)在一端加以密封,所述尾塞脆弱地与圆筒连接;
ii)在所述无菌环境中以一注射液介质对圆筒(2)进行无菌灌装;
iii)将一预先消毒塞头(3)引入无菌环境;
iv)将该预先消毒塞头(3)在无菌环境下装入圆筒打开端;
其特征在于,在圆筒灌装之前、之后或灌装过程中分开注塑模制一包括尾塞保持装置(7)的上盖(6),所述上盖装配在尾塞(4)上,当上盖处于一第一位置时连接于所述圆筒的封闭端,不会导致尾塞与注射器(1)的脆弱连接部断裂,但可以从该第一位置移动至一第二位置,在第二位置上,尾塞(4)由尾塞保持装置(7)固定和保持,将上盖(6)从第二位置去除会导致尾塞(4)与注射器的其余部分分开,从而显露注射液供注射用。
17.如权利要求16所述的方法,其特征在于,所述上盖(6)在与对打开端圆筒(2)进行注塑模制的环境相同的无菌环境中模制,且所述上盖(6)在所述无菌环境中与所述圆筒的尾塞端连接。
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AUPM9223A AUPM922394A0 (en) | 1994-11-03 | 1994-11-03 | Plastic syringe with overcap |
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- 1995-10-31 HU HU9701698A patent/HU218191B/hu not_active IP Right Cessation
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- 1995-10-31 BR BR9509431A patent/BR9509431A/pt not_active IP Right Cessation
- 1995-10-31 AU AU37664/95A patent/AU683591B2/en not_active Ceased
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- 1995-10-31 JP JP8514896A patent/JPH10508232A/ja not_active Ceased
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- 1995-10-31 PL PL95319941A patent/PL178752B1/pl not_active IP Right Cessation
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