CN1119182C - 计量剂量吸入器及使用该吸入器排放雾滴液体的方法 - Google Patents
计量剂量吸入器及使用该吸入器排放雾滴液体的方法 Download PDFInfo
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Abstract
一种计量剂量吸入器,包括一个安装在器械主体内腔(2)中的活塞(3),该活塞被一予加载弹簧(6)推进一截面较细的压力腔(4)中。该话塞可以用有把手(32)的启动棒(31)来加载,还可以通过闩锁装置(33)锁在承载的位置上。液体药物(例如在水溶液中)盛在胶囊袋(10)中。一定计量的药物量被逐渐吸入压力腔(4)中。然后通过释放弹簧承载活塞(3)压力突然急剧增大,通过雾化头(22)喷射液体药物使它成为细小的颗粒(例如小于30微米)的精细雾化喷剂。
Description
本发明涉及雾化机械和方法,特别是(尽管不是专门地)与雾化喷敷药物的应用有关。
雾化器使用范围很广,有各种不同用途的多种不同型式的雾化器。例如,所谓“扳机式雾化器”在家庭中,广泛地被用于喷洒清洗剂和磨光剂。所谓“垂直轴泵压雾化器”,广泛地用于喷洒护发药品和用作鲜气喷筒等等的应用中。
为了将喷洒的液体加压喷出,这两种雾化器都依赖于一操纵器运作时的泵浦作用。
在家庭应用中,通常不看重雾化器每次动作在喷洒量和/或喷雾产生的颗粒的大小是否完全相同。的确,在一般情况中,喷雾量和颗粒大小,非常依赖于操纵器运作行程的长度和/或强度。
通过装有降压阀或类似物,以改进雾化器的目的在于给出一定程度的“快动作”机制。当施加一最小压力时喷雾动作就开始。然而这样做远非准确,因为(a)这个最小压力值会被强有力的操作者不同程度地超过,(b)如果操作者操作行程不完全,喷雾动作就会过早地终止。
在WO 87/04373中,给出了一个适合于喷洒护发剂的改进的“快动作”垂直轴泵式雾化器的例子。尽管在此例中无须准确度,但因为这个最小压力可能被超过,喷雾动作依然依赖于操作者。在操作时如果手指压力消失,操作行程就会不完整,和/或手指的压力变化也会导致喷洒性能的变化。
在医疗应用中,能够准确并可重复地配给一定剂量的药物,就变得十分重要。
目前许多药物是通过“计量剂量吸入器”(MDI)用药的。这些器械产生药物的精细雾粒,然后被用药者吸入。现在,除了少数换鲜器和非救急药品外,大多数MDI要么是使用CFC(氟氯化碳)推动剂的气雾剂器械,要么是干燥粉末器械。
由于大部分药物是不溶于CFC的,通常药物是处于微粒化状态,即变成其颗粒平均直径为5微米的精细干燥粉末或晶粒。这些颗粒都在一定压力下,通常是在压力金属瓶中贮存,它们悬浮在CFC的液化气相中。在用药时操作放气阀,将一内部计量室与外部大气连通,一定计量的液化气和药粒迅速沸腾和膨胀,载着药物颗粒喷出阀门外。
如CFC之类的气雾剂有许多优点。其液化气能在小的体积中贮存大量的能量。因此,很容易地生产出便携式,袖珍型的气雾剂,这已足以在可重复的情况下供给充足的药量。
然而,CFC的另一个潜在的优点,它的惰性,已是目前关于臭氧层问题争论的中心。由于CFC被认为会耗尽臭氧层,1987年大部分发达国家都在蒙特利尔协定上签字,拟逐步取消CFC的使用。
尽管有完全取消使用CFC的巨大压力,但由于替代的配药方法或推进剂尚不适用或没有找到,医用推进剂依然被允许使用CFC。
事实上,在最近,即1990年3月,在美国科罗拉多州吉斯通、有250名第一流的世界专家出席的“呼吸药物传送II”会议上,除了CFC一型液化气推进剂(包括新引入的HFC-和HCFC-推进剂)或干燥粉末器械之外,他们甚至没有认真考虑任何其他种形式的MDI传送。干燥器产生干粉颗粒的雾或云状体,但由于它们既不是气雾剂,也不是喷雾器械,所以与本发明并不太相关。然而,尽管大部分使用者都感到,碰在咽喉后面的干颗粒有撩痒的感觉令人十分不愉快,但这些干粉末器械中较好的几种都在商业上获得了成功,这有趣地反映出对于改进传送器械的实质的需要。
尽管大部分药物不溶于CFC,某些处方还是使用了共溶剂和表面活性剂。对于精细的气雾剂,这些通常是不适宜的,因为在气雾剂活性作用之后,随着CFC的蒸发,液滴的平均直径马上开始变化,速度下降,使用者吸入的是经常改变大小和速度的颗粒。所以很难预料药效。
为了达到最大的药效,药物的平均直径在某一预定范围,例如1到8微米或1到5微米是非常重要的,这样当药物被吸入后就可能到达肺中的肺泡小囊中。较大的颗粒会被上呼吸道吸收并引起不良付作用。较小的颗粒则会被呼出。
使用CFC推进剂的气雾剂,能以较确定的大小传送药物,这是由于CFC迅速蒸发,留下的成核颗粒化药物具有预定的大小。然而,它们具有上面所述的对周围环境有害的影响。同时,它们还有一个缺陷,由于蒸发而冷却使得在吸气时感觉CFC是冷的气体。这会引起支气管收缩,因而降低喷药效率。还有,因为CFC比空气重得多,所以要将肺中的CFC全部呼出需要一个长时间,而这会减小氧的传送,又降低了药效。
CFC的另一个缺点在于:室温下CFC的蒸发率太大以至于一定剂量的药物的合速度很高。因此,药物通常以一个很显著的速度撞击咽喉后部,使人有些不舒服。况且,对于药物来说,其最佳路径是沿咽喉而下进入支气管的一条弯曲路径,到咽喉后部的高速路径是偏离这个最佳路径的。
CFC的另一个缺点是它不能与水混合,对于最大量的生理治疗,许多药物应该是溶于水的。
泵浦式喷雾器已被用于医疗。例如参看US-3838686,US-4694977和GB 1481199。然而它们都没能成功地解决重复性问题,也就是说,在一定的和可重复的颗粒大小,形状和压力下,重复传送一定剂量的药物。相反却总是依赖于操作者。GB-1481199权利要求提出了预定的可重复产生的喷雾液滴大小的谱,但事实上只是提出了最小操作力。强的和/或突然的操作力将给出不同的结果。
也应认识到,用垂直轴手指泵,是不可能产生医疗吸入应用所需的足够压力,它需要极小的颗粒大小。
有趣的是,US-4892232,其目的也是在一预定压力下,喷出定量的液体,它使用的是封在液化瓶中的弹性胶套中积蓄的能量。然而,其说明书十分清楚地表明,在使用中,压力实际上发生显著的变化,参看3栏28行~36行。
US-4147476,4693675和4842495号专利的目的在于提供利用使用者手指压力压缩的一弹簧的能量来雾化液体的装置。然而,这动作分为两阶段,液体首先被压缩,然后由于密封体的变形受压液体被喷出。由于密封体必须强到足以抵抗变形之前液体的压力,而耐高压的密封材料很难得到和/或很昂贵。所以这类装置不适于高压液体的应用,由于压力是直接由使用者手指施加的,缺乏机械上的优点,所以该装置又不能很好地适于高压应用。
尽管美国专利US-4842495,例如,声称提供了喷放剂量不依赖于手指压力。然而,如果使用者手指压力过量地减释,那么仍有可能使药剂在喷放时突然中止。在上面所叙述的所有三个专利中(以及许多其它专利),在喷放的瞬时,喷嘴必须移动,这是由于喷放喷嘴本身构成致动器按钮的一部分,而该按钮是被使用者按压以启动喷雾。如果使用者企图使用该装置作为吸入器,那么上述状况,使其难于导引喷嘴正确地进入咽喉。
美国专利GB-405458公开了消毒剂自动喷洒到使用后的电话送话口的器械,在这方面,所希望的喷雾或喷射的准确性,不高于目前一般家用的器械,如清洗器、抛光器等。其实,在图1到图13所示的主要实施例中,其运作将依赖于将电话听筒放回原处有多么平稳。在图14至图18的实施例中,则似乎给出其运作至少在某种程度上是可重复的。这似乎不是这个实施例的目的,而其直正相关的是仅在电话听筒放回原处预定多的次数之后,才引起液体被喷进话筒送话口。该专利说明书并没有讲授关于喷雾或喷射的准确性和重复性。并且其设计清楚地表明不适用于精细地雾化喷敷药物的应用,如用于计量剂量吸入器。
本发明最佳实施例的目的在于,改善这样的在先申请的缺点。
本发明的最佳实施例目的在于提供不依赖于CFC的使用或类似的推进剂的使用的计量剂量吸入器,而且还是在可重复的压力及平均颗粒大小条件下以相同的剂量重复地供给药物。最好药物以水溶液形式贮存和喷雾。
尽管本发明,主要应用在计量剂量吸入器上,然而,它还可以更为普遍地应用于广泛的领域。
根据本发明的第一个方面,提供了一种雾化器械用于以喷雾形式传送一定计量的液体。该器械包括:
增压装置,用于把予定的能量加到一定计量的液体上,以使它的压力增加到予定值。
雾化装置,用于雾化已加压的液体。
最好,雾化器械还包括计量装置,用于计量所说的液体。
最好,由所说的增压装置,施加到一定计量的液体上的所说压力增加使得加压的液体通过所说的雾化装置,由此雾化。
雾化装置还可以包括:
压力腔;
输送液体并与所说压力腔相连的入口,以及从所说压力腔接受加压液体并与之相连的出口,并且
所说雾化装置装在所说的出口上或其附近处。
所说增压装置包括用于产生脉冲的脉中产生装置,和响应所说的脉冲并改变所说压力腔的体积以增减压力腔中压力的启动装置。
雾化器械还可以包括控制装置,用于控制在所说的压力腔、所说的入口和所说的出口之间液体的流动。
最好所说的压力腔由一个园柱缸体构成。
所说的启动装置可以包括一个活塞,
最好,所说的脉冲产生装置包括一个能量贮存装置和从该能量贮存装置释放能量的释放装置,由此产生至少一个脉冲。
雾化器械还可以包括向能量贮存装置加载的加载装置,锁定该能量贮存装置于负载状态的锁定装置,以及释放该锁定装置的释放装置从而释放能量贮存装置。
所说能量贮存装置;还可以包括一个弹簧。
雾化器械进一步还包括一个液体容器,所说的计量装置从该容器中吸出液体并予以计量。
最好,所说容器盛有一种药品或其它药物。
雾化器械包括至少一部分可从该器械上拆卸下来的部件,作为可替换部件。
最好,所说容器是可拆卸部件。
至少所说控制装置的部分是可替换部件。
所说的活塞可以是可替换部件。
雾化器械可以设计成将液体雾化到平均颗粒大小为100微米或更小,30微米或更小,20微米或更小,或10微米或更小。
雾化器械可以设计成将液体雾化到平均颗粒大小为0.1微米或稍大,或1微米或稍大。
雾化器械可以设计成将液体雾化到平均颗粒大小在1-12微米范围。
雾化装置可以包含一个雾化孔,该孔具有直径100微米或更小,50微米或更小,30微米或更小,20微米或更小或10微米或更小。
雾化装置可以包含一个雾化孔,该孔具有直径1微米或稍大,或5微米或稍大。
雾化装置可以包含一个雾化孔,该孔具有直径在3到60微米范围,或直径在2-12微米范围。
增压装置可以设计成巴一定计量的液体的绝对压力,提高到500巴或稍低,300巴或稍低,或200巴或稍低。
增压装置可以设计成把一定计量的液体的绝对压力,提高到50巴或更高,100巴或更高,或150巴或更高。
增压装置可以设计成把一定计量的液体的绝对压力,提高到压力为50到250巴范围。
增压装置可以设计成把一定计量的液体的绝对压力,提高到压力为200到350巴范围。
所说液体可以是水溶液或悬浮液。
雾化器械可以装有调节装置,用以调节所说能量的予定量值。
雾化器械可以装有调节装置,用以调节由所说计量装置计量的液量。
最好,所说雾化装置包含一个安装在该器械主体内或表面上的出口孔,并且该器械还包括一个相对于所说的器械主体是可动的构件,以启动所说的雾化装置工作,该设计使得所说构件的移动不引起所说孔的移动。
在第二方面,本发明提供由如上述所述的并根据本发明的第一方面作出的雾化器械构成的计量剂量吸入器。
最好,该计量剂量吸入器还包含一个接管,使用时,雾化装置在其内部传送雾化喷敷药物。
第三方面,本发明所提出一种以喷雾方式传送一定计量的液体的方法,包括下列步骤:把予定量的能量加到一定计量的液体上;使其压力增加到予定的压力;使加压的液体通过雾化装置,并将液体雾化。
最好,所说的液体是一种药剂或其他药物
最好,用如上所述并根据本发明的第一方面所作出的器械,把液体加压和雾化,或者用如上所述并根据本发明的第二方面所作出的计量剂量吸入器,把液体加压和雾化。
为了更好地理解本发明,并表明发明如何实现其效果,下面将结合实施例,参照附图,予以说明。
图1是一种计量剂量吸入器的剖视图,它带有装在软袋中的待用药物。
图2是类似于图1的视图,但是带有装在加压容器中的待用药物。
图3是另外一种计量剂量吸入器局部剖视图,其中待用药剂盛在软管中,软管有作为活塞的喷嘴。
图4是类似于图3的视图,表示了另一种加压设计。
图5是一种雾化孔系统实施例放大的详图。
图6是机制的断开孔的一种实施例放大的详图。
图7粗略地描绘了另一种雾化装置;以及
图8粗略地描绘了又一种雾化装置。
在图中,同样的标号表示相同或相应部分。
下面的叙述将参照附图,给出若干实施例。
如图1所示的MDI,包括一个主体1,它是一个具有一环形截面的圆柱缸体2,其中安装一个活塞3可作往复运动。圆柱缸体2与一个截面缩小了的压力腔4连通。该活塞3有一个较细直径部分5,它在压力腔4内密封啮合,使用的是装在活塞部分5的塑料密封套或环(例如聚四氟乙烯或尼龙)。可以与活塞较细直径部分5整体构成密封,例如装一个套,肋或垫圈。
预负载压缩弹簧6装于圆柱缸体2之内,即在活塞较粗的头部3和相对的圆柱缸体2端壁之间。一个操作棒31连接到活塞3上并通过弹簧6和主体1内通道34,从主体1中伸出。在棒31的端部或靠近该端部处,装有把手装置32,以便移动棒31和活塞3。一个安装在主体1上的闩锁装置33与棒31啮合,在负载位置,闩锁棒31,如图1所示。还装有一个启动按钮35,以便释放闩锁装置33。
同时,在主体1内还有一个空腔15,在其中装有软袋10,该袋装有待用药物(如液体药剂)。为了更换软袋10,在主体1的侧边有一个可打开的门16。用连接器12,把袋10的内部与入口通道11接通。该通道则通过一个不可逆阀门13与压力腔4连通。
同时,与压力腔4连通的是一个出口通道21,它通过一个不可逆阀门23和一个压力释放阀25,从压力腔4延伸到雾化头22。
此外,主体1上装有一个喷嘴罩40,它围绕着雾化头22形成一个雾化室。
在如图1的MDI使用中,在活塞3处于如图1所示的负载位置时,压力腔4充满由袋10通过通道11和不可逆阀门13所供给的液体。如前所述的压缩弹簧,当它安装在圆柱缸体2中时,已经处于预负载。通过拉动棒31,从而拉动活塞3到图1所示负载位置,更增加了弹簧的负载。
用闩锁装置33,把棒31闩锁在它的负截位置,如图1所示。按压启动按钮35,释放闩锁装置33,在压缩弹簧6的弹力力的作用下,活塞3突然向前移动,把一个突然的压力脉冲加到压力腔4内的液体中。
所以,压力腔4中的液体压力,很快地上升直到超过压力释放阀25的极限值。然后在高压作用下,压力腔4中的液体,通过出口通道21,经过单向阀23,喷射到雾化头22。当活塞3向前穿行时不可逆阀13阻止液体通过入口通道11,返回到袋10。当液体通过雾化头22喷射时,它被雾化成精细的液雾,而后被吸入。附加的喷嘴罩40提供了一个雾化室,将喷射的细雾围住并促进了喷雾的吸收。
为了重新给MDI加载,用手柄32抗住弹簧6的弹性作用,把棒31拉回,在它行程的末端,闩锁装置自动地把棒31锁定在锁端位置。在活塞3作上述穿行期间,液体被从软袋10中吸出,通过入口通道11和单向阀门13,进入压力腔4中,于此同时,单向阀门23则防止空气被通过出口通道21吸入压力腔4中。
所以,该MDI又处在负载位置,如图1所示,准备使用。
可以看到,在如图1所示的MDI使用中,经计量的一定剂量的液体,被以高度准确和可重复的方式加压和雾化。当棒31和活塞3被拉到它们的负载位置时,精确计量的液体被吸入压力腔4中。在释放闩锁装置33时,活塞3疾速地向前把予定量的能量加到液体上,由此,把其压力增加到一个预定量。所以,当加压液体,通过有预定雾化特征的雾化头22喷射时,液体被雾化成有预定平均颗粒大小的精细液雾。
为了把液体雾化成很精细的液雾,例如,具有平均颗粒大小在1到12微米范围,必须给压力腔4中的液体加上很高的压力。举例说,压力腔4的容积可以是20微升,活塞3的小端直径可以是2毫米,圆柱体2的直径可以是15毫米,弹簧6的力可以是100牛顿;以及雾化头22可以有一个直径在3到15微米量级的出口孔,在这样的设计中,在压力腔4中的液体中,可以产生300巴量级的压力。
空腔15可以向大气开放并处于大气压下。在另一个实施例中,腔15可以加压到大气压之上,这有助于迫使软袋里面的东西进入压力腔4,而无须在压力腔4中低于大气压的压力。这样的设计可以避免在吸入压力腔4中的液体内形成气泡。
可以附加压力释放阀门25,如果希望的话它也可以被省略。压力释放阀25和不可逆阀23可结合成单一体(没有示出)。可以认为,图1的图示实质上是概略图。实际的实施例可以有不同的结构。例如,可以使用一个杠杆或其它齿轮机构,以帮助活塞3抵抗弹簧6而加载。
在一个实施例中,MDI可以安装一个盖,当盖打开时,它自动地加载活塞3并且闩锁该闩锁装置33,使得MDI就处于待启动状态。当盖打开时,MDI将被启动按钮35启动。在另外的实施例中,活塞3可以在MDI的盖被盖上的同时,抵抗弹簧6而加载,并且闩锁闩锁装置33。所以,该器械已被预加载了,并且当打开盖时,可以立即启动。在另一种改进中,打开该器械的盖时可以自动地抵抗弹簧6对活塞3加载,闩锁该闩锁装置,然后在开盖动作终结时,自动地释放该闩锁装置。
图1的MDI,最好是小巧、袖珍型的,因为相对于已知的MDI,它不须要提供相当大的体积,以盛装在一定压力下的液体气体推进剂。所以,它能容易地制成小巧的尺寸。除此之外,如软袋10形式的药剂容器,能盛装比通常的MDI更多的药物。例如,通常的MDI可以装载仅200到400剂量,而按照图1所示构造的MDI,在软袋中很容易盛装1000或更多的剂量。还可以看到,装在袋10中的东西能被保护以免于大气的沾污。
当袋10空了时,它可以简单地由空腔15中取下来,并用一个新袋替换。最好,袋10有密封以阻止药剂从袋10中逸出,直到袋10被连接到连接器如12之后。
在另一个实施例中,活塞和/或阀门的一部分,可以和药剂容器如软袋10一起,设计成可拆卸的。
可以看到,在图示的MDI使用中,一旦按压启动按钮35,释放闩锁装置33,从而释放弹簧6,就不会有任何事情能阻止压力腔4中所含有的东西被释放并雾化后喷洒出来。因此,弹簧6加到压力腔4中一定计量的液体上的能量是绝对地被预定的,使得一定计量的液体的压力增加也同样是绝对被预定的。在以下描述的所有本发明的实施例中,实现了上述的目的。
图1中MDI的另外特征在于:只当按压启动按钮35以释放闩锁装置33并由此释放弹簧6时,压力腔4中一定计量的液体才被施加压力。其优越性在于:无须密封或其它装置,在雾化过程之前,来约束高压液体。被弹簧6和活塞3施加到压力腔4中一定计量的液体的压力,导致受压液体通过雾化头22并由此雾化。在以下描述的所有其它的实施例中,也实现了上述目的。
图1中MDI另外的重要优点在于:按压启动按钮35以释放闩锁装置33和弹簧6时,在主体1内的雾化头不动,而只有按钮35动。这样相对于通常的垂直轴手指泵的设计、就容易正确地定向喷雾,而后者在使用时,雾化喷嘴本身被按压以启动雾化过程。在医疗吸入器中,这是不方便的,因为它难于正确地定向喷雾。在以下描述的所有其它实施例中,又实现了这个目的。
如图2所示的MDI,基本上类似于图1的MDI。然而,在图2中,没有安装压力释放阀25。同时,药剂容器包含长管16,液体制品17在一定压力下贮存在其中。该压力是由贮存在液体制口17之后的气体容器中的气体18所产生的。当活塞3拉回到承载位置时,在气体18压力作用下液体制品17被迫经过入口通道11和不可逆阀门13,进入压力腔4中。当使用液体制品17时,气体18膨胀进入管16,推动液体制品17向前并损耗一些压力。气体18的初始压力,应该充分保持在大气压之上,直到所有液体制品17被用掉。
压力管16可以制成可替换的,当液体制品17被用完后,以便更换MDI。此外,由于整个MDI主要是塑料部件所以造价可以十分低廉。这样可以用后即弃。如果管16至少有一部分从MDI的外边是可见的,那么根据其中剩余制品的液位,就可看出是否已用完。
在图1和图2的实施例中,喷雾动作是通过启动按钮35启动的。在另一种设计中,闩锁机构33,可以响应靠近雾化头22的使用者的吸入动作而自动释放。例如在喷嘴罩40上可连接一个叶片,使用者吸者时,叶片两边的压差会引起叶片移动,由此释放闩锁机构33启动喷雾动作。在已有的MDI中,这样自动启动机构本身是已知的。
在图1和图2的实施例中,活塞3的行程是固定的,如果希望的话,可以提供用于变化活塞行程的装置。最好,这样的装置被刻度,使得使用者可以随意地调节MDI,以确定喷洒不同的药量。然而,将看到:在每一种情况下,一旦调节装置取定一个特定值之后,MDI就可以提供高度重复地,相同剂量的喷洒剂量,恰如活塞的行程被固定一样。
如图3所示的实施例中,液体制品50被盛在软管51内,该软管51和一个延伸出来的喷嘴52整体地成形,该延伸喷嘴52则作为一个活塞。喷嘴/活塞52可以圆柱体53之内作往复运动。在喷嘴/活塞52的端部,加一个简单的不可逆阀门54。压力腔55限定在圆柱体53的端部,并通过简单的不可逆阀门56,与雾化头57连通。圆柱体53,不可逆阀门56以及雾化头57,所有的都装在壳体58之内,壳58带有一将其定位在第一主体部件60之内的环形肋59。
制品软管51的顶部,带有一将软管51定位在第二主体部件62之内的环形肋61。弹性位移装置,促使两个主体部件60和62相互靠近。闩锁装置,在有承载条件下,闩锁两个主体部件60,62分开予定距离;启动装置用于释放闩锁装置。为了清楚起见,弹性位移装置,闩锁装置和启动装置,没有表示在图3中,但是这些部分的例子已表示在图1和图2中。
图3实施例运作方式如下所述。
如图3所示,该MDI是处在没承载或“已喷完”状态。用适当机构,把主体部件60和62相互移开,导致喷嘴/活塞52相对圆柱体53拉出。在压力腔55中,降低的压力,引起液体制品50被从管51中吸出,经过不可逆阀门54,充满压力腔55,在上述动作期间,不可逆阀门56,阻止空气由雾化头57进入压力腔55中。
在加载行程结束时,闩锁装置把主体部件分开并固定在预定的相对位置上。用启动装置释放闩锁装置时,喷嘴/活塞52,以基本类似于图1和图2实施例中的方式,在弹性位移装置作用下,突然急促进入圆柱体53中,对在压力腔55中的液体制品50突然加压,受压液体制品就在压力下,通过不可逆阀门56,射入雾化头57,然后通过雾化头57雾化成精细液雾。
随后,用各自的杠杆机构,抵抗弹性位移装置产生的力,再把两个主体部件60,62分开重新给MDI加载。
所以,可以看到,图3实施例,运作方式基本上类似于图1和图2实施例的方式。然而在图3中,以特别方便的方式提供了盛在软管51中的制品50,软管51可以和喷嘴/活塞52以及一简单的不可逆阀门54,制成一体,用后弃掉。还可以看到,软管50和与它成一体的喷嘴52以及不可逆阀门54,可采用塑料材料这种相对经济的方式很容易地制造。除了当MDI在已启动时,使用者避免和液体制品50接触。适当地结合图3实施例的特征,可以给出图1和图2实施例的特征,包括以上讨论的种种变化。
在图3实施例中,部件60,62的任一个可以相对于MDI主体而固定,而部件60,62中的另一个相对于固定部件是可动的。此外两个部件60,62都可以相对于MDI主体运动。
在图4的实施例中,液体制品70被盛装在软管71内。软管71的喷嘴72与装有不可逆阀门74的入口通道73相连。不可逆阀门74与变形管75相通,变形管75可以在“满”位置(实线表示)和“空”位置75a(破折线表示)之间变化。变形管75与另一个不可逆阀门76连通,该阀门76则与雾化头(没有画出)连通。变形管75装在压力腔77内,该压力腔装满了辅助液体78。该辅助液体78,经过通道79与压力脉冲产生器(没有示出)连通。
图4实施例运作方式如下。
当变形管75在它的“满”位置时,它充满了由软袋71吸取的液体制品70。在把压力脉冲加到辅助液体78上时,在压力腔77中的压力突然增加,这引起变形管75急剧地进入“空”位75a。当其动作时,在高压下管75中的液体制品,被排出不可逆阀门76到雾化头(没有示出),致使雾化头将液体制品雾化成精细液雾,基本与前面实施例一样。
在压力脉冲终止时,变形管75恢复它的初始“满”位置并且在这个动作期间,液体制品70由软管71被吸上,通过不可逆阀门74,进入变形管75内的空间。变形管75在其自身的自然反弹下,可以回到它的“满”位置。另外地或附加地,通过把负的或减压脉冲加到压力腔77中的辅助液体78上,有助于其返回“满”位置。
通过任何适当的装置,可以在辅助液体78中产生压力脉冲。然而,重要的是,压力脉冲要有预定幅度和持续时间,以保证一定计量的液体,重复地吸入变形管75,并且随后,在预定的压力下,从其中被排出,从而通过雾化头产生可重复的喷雾量。
举例来说,压力脉冲产生器,可以包括活塞和圆柱体,以及闩锁装置,启动装置,即基本类似于图1和图2所示类型。
典型地,压力脉冲实质上可以是矩形波形式。然而,如果希望的话,压力脉冲可以是任意预定的形状,但要慎重地选择时间变化的喷雾谱。重要的是,不管脉中形状怎样,它们能正确地重复。这可以适于所有的实施例。
图5表示一个雾化头系统80的一个实施例的放大详图。一个在主体82中的入口通道81,接通到入口室83。在入口室83接口截面之间,插入一个过滤器84。入口室83的最后一节接到旋流室85,旋流室再接到喷嘴86。
过滤器84的目的是阻止颗粒阻塞最末的出孔。例如,过滤器84可由不锈钢网眼制成,网眼大小在1至10微米范围,最好是3微米。
图6所示为雾化孔90的一个实施例。孔90就成形在板91上,板91可以被定位,例如定位在图5所示系统中雾化喷嘴86的下游,如图中点划线所示。
由图6可见,最后出口孔90直径为6微米,全长30微米,包括一向内张开的,与垂直面成30°角的锥形咽道92,和一个向外张开的嘴93。孔板91厚度为1毫米量级,并且锥形入口通道长度约为1毫米,从70微米大小的初级进入孔,成20°锥角张开。我们惊奇地发现,使用约6微米的最末雾化孔,再加上施加到被雾化的液体的高压(通过能量存贮装置,如压缩弹簧6等),能得到很有效和均匀的平均颗粒大小的液雾。测试表明,用一个6微米量级的出口孔,如图6所示,与300巴量级的液压,产生了平均颗粒大小5-8微米量级的均匀的液雾。最好,出口孔90的直径小于100微米。直径最好是在1-20微米范围,而最佳的范围是3-10微米。
通过在板91上钻孔,可以构成出口孔90,例如,用碳化钨针(例如:类似于在纺织工业中用于构成纺织狭孔那样)。
尽管雾化孔被优选,然而可能使用别的雾化装置。
例如,如图7所示,通过出口孔104,可以产生液体射流102,以高速度射到物体上,例如金属球,然后,使液体雾化。
另一种设计如图8所示,两条液体射流110,以高速度和高压相撞,使得在它们相撞点该液体雾化。
用在这里描述的实施例的,至少是其中一部分的构造的MDI所作的实验证明有令人惊奇的效果,它们可以很容易地提供能重复的,平均颗粒大小小于30微米的药物液雾剂量,典型地是3-10微米量级。平均颗粒大小在2至8微米,或小于5微米,是最佳的。本发明这些实施例特别重要的方面是,药物可以在水溶液形式下被即刻使用。目前使用的许多药物,有两种配方-一种用于MDI中,而另一种用于医院里通常使用的喷雾器中;后一种配方,几乎永远是药物的水溶液。所以,它们可马上使用本发明的实施例。
实施本发明的MDI,药物能够应用于水溶液,这可能会加速新药物的发展。这是因为目前许多长期试验是为了确保推进剂(典型的,如CFC)不降级或影响药物和它的效果。当然,在描述的实施例中,没有需要别的推进剂。
目前,通过MDI用药的许多药物,涉及支气管扩张器,及类似的用于处理哮喘,过敏以及充血机能失调的药物。然而通过吸入疗法,还能治疗其它病症(例如肺细胞隆凸)使其重要性日益增长。其理由在于:通过胃用药经常被胃分泌破坏,或者药物进入血流被肝吸收,(首先通过新陈代谢)另一方面,副作用可能是严重的。这些新药中的某些,是很难微粒化的,直到现在,只有在医院通过雾化作用,它们才被服用。因为便携式药物传送方法,以前还没有使用。医院的雾化器典型的包括气喷器,其中,少量的液体制品,在高压下被加到大量的喷气中,这样的设备需要大的气缸。所以,这肯定不是便携式的。(当然,是在袖珍大小或类似器件的意义上来讲)。本发明的实施例,可以很容易地把这样的药,应用于容易便携的器械,并且一个重要的优点在于,这样的实施例马上可以用于喷敷已经检验过并且对于雾化器的使用是可用的药物。
所描述的实施例,它们特别有用的优点在于,它们可在任何方位上,十分满意地使用。与此对照,已有的喷雾器--推进剂型(例如CFC)和泵作用型-两种型式都只工作在一种方位,(通常是竖直)然而不可能希望病人总是处于直立位置。
正如在前面描述中所建议的,本发明实施例可以包括至少部分是透明的制品容器,使得其含量可直观地检验。
本发明描述的实施例又一优点在于:无须使用任何弹性密封部件,可以制造得十分满意,而对照我们知道的所有已知的MDI,它们是使用弹性密封部件的,而弹性密封部件与被喷洒的制品接触时,有可能降低弹性,和/或由弹性体(例如橡皮)中提取药物,其成分可能会浸入将被喷洒的制品中。
本发明最佳实施例不需要弹性密封而有很好的功能的理由在于,制品不须在高压下贮存。在雾化循环周期中,高压只出现很短的时间。所以,例如在图1和图2的实施例中,只需要在活塞端部分上有密封套或密封环就行了。如上所述,它们可以是聚四氟乙烯或尼龙材料制成。其实,完全由不锈钢和检验过的塑料材料(例如聚丙烯,聚四氟乙烯或尼龙)来制造图1和图2的实施例,是既有可能又有希望的。上述的检验过的塑料是完全安全的,并且与被喷洒的制品不起反应。
如果,在连接器12处有密封需要,可以装个塑料制的(如四氟乙烯)的密封环或垫圈。另外地或附加地,该连接器12可以包含螺旋啮合部分,并且,至少其一部分是由检验过的塑料制作的。
在图4实施例中,如果希望的话,有可能在压力脉冲产生器(没有表示出)内使用弹性密封。这是因为制品70,通过变形管75和辅助液体78,与这样的密封完全隔离。变形管75是由检验过的塑料制成的例如,聚丙烯,聚四氟乙烯,尼龙)。
在图1和图2的实施例中,被强弹簧推动的机械活塞,用于产生施加到压力室4中的液体上的压力脉冲。别的装置也可以用来产生这样的压力脉冲。例如,气体弹簧5,电马达,螺线管;或其它可以使用的装置。
尽管以上描述的本发明实施例,使用液体制品,典型地其可以包括药物水溶液,然而,其它液体制品也可以使用。例如,可以使用悬浮液或溶于水,乙醇或其它种液体中的液体。
如上所述,本发明上述实施例,可以在比通常的MDI低得多的速度下,喷射液雾。例如,在通常的CFC推进剂MDI中,发射的液雾云团或气泡,可能达到每秒30米量级的速度。本发明最佳实施例,可以只以四分之一的该速度释放等量的液雾量。其实,有可能设计本发明实施例,与使用者每分钟60立升量级的最佳吸入率相匹配。
已描述的本发明实施例,包括用于计量被雾化液体量的装置。在另外的实施例中,雾化器械,可以带有预计量的被雾化液体。例如,一种箔带或塑料材料(或其它种材料),可以装有预计量的一个剂量的液体制品。而且,该箔带材料能预先或作为加压操作的一部分,局部穿孔;随后液体被雾化成精细液雾。最后,箔带材料在预定位置,可以预软化,当需要时,促使箔带材料恰当地破裂。另外,预计量的液体制品剂量,可以盛在单个胶囊中,顺序地被送到压力室,或其它加压位置,然后在那儿胶囊破裂。这些带材或胶囊可以设计成,在雾化器械所加的预定压力下破裂。这样在破裂时,在液体制品中,产生了压力释放效应。
读者应注意到,与本说明书同时或在先申请和已用说明书对公众公开的所有这样的文章和文献,所有这些文章和文献的公开内容都通过引用结合在本说明书中。
所有公开在说明书中(包括任何同时提出的权利要求,摘要和附图)的特征,和/或同样公开的任何方法或过程的所有步骤,除了组合后使至少某些这样特征和/或步骤相互抵触的之外,可以任意组合。
公开的说明书中(包括任何同时提出的权利要求,摘要和附图)的每一个特征,除非另外明确地表明之外,都可以用另外的、严格相同的,等同或同样目的的特征代替。所以除非另外明确地表明之外,公开的每一个特征,只是一系列等同或同样特征的一个实施例。
本发明不限于上述实施例的细节。本发明扩展到说明书中(包括任何同时提出的权利要求,摘要和附图)所公开的特征的任何一个新的特征,或任何新的组合,或者扩展到,同样公开的任何方法或过程的步骤的任何新的一个步骤或其任何新的组合。
Claims (23)
1.一种散布一定计量的雾滴液体的计量剂量吸入器,它是通过在压力下通过一个雾化装置(22;57;80)排放一定计量的液体的方式散布的,其中该计量剂量吸入器包括:
一个用于容纳一定计量的液体的腔室(4;55;75);
一个能量储存装置(6),该能量储存装置(6)用于保持预定量的能量并将该预定量的能量施加到该腔室(4;55;75)内,以便使所述一定计量的液体的压力从低压增加预定的压力达到50巴或者更高的较高压力,从而可使所述一定计量的液体从该腔室(4;55;75)内以该较高的压力排出,其中在此预定量的能量储存过程中所述能量储存装置(6)可使所述腔室(4;55;75)内的压力降低到能使所述一定计量的液体进入到所示腔室(4;55;75)内;和
一个雾化装置(22;57;80),用于接纳从该腔室(4;55;75)中排出经过加压的所述一定计量的液体并且借助该较高的压力雾化所述一定计量的液体以产生雾滴液体,所述雾滴液体的尺寸大小可使其适合于吸入肺中;
该计量剂量吸入器的特征在于,它还包括:
用于将预定量的能量施加到所述能量储存装置(6)上的装置(30,31,32);和
用于将所述预定量的能量从所述能量储存装置(6)释放到所述腔室(4;55;75)内的装置(33,35),以便使所述一定计量的液体的压力从较低的压力增加预定的量达到较高的压力,从而使所述一定计量的液体开始从所述腔室(4;55;75)中排放出。
2.如权利要求1所述的计量剂量吸入器,其特征在于:所述雾化装置包括一个具有100微米或者更小的直径的出口孔(90;104)。
3.如权利要求2所述的计量剂量吸入器,其特征在于:所述能量储存装置设计成在将所述预定量的能量施加到所述一定计量的液体上时可使所述较高的压力达到100至500巴。
4.如权利要求1所述的计量剂量吸入器,其特征在于:该出口孔(90;104)具有1至20微米的直径。
5.如权利要求4所述的计量剂量吸入器,其特征在于:该出口孔(90;104)具有2至12微米的直径。
6.如权利要求1-5中任一项所述的计量剂量吸入器,其特征在于:该计量剂量吸入器包括一个用于将所述腔室(4;55;75)和所述雾化装置(22;57;80)连接起来的通道(21),该通道(21)结合有一个用来调节所述腔室(4;55;75)和所述雾化装置(22;57;80)之间的液体流的压力释放阀(25)。
7.如权利要求1-5中任一项所述的计量剂量吸入器,其特征在于:设置一个装置(33)将所述能量储存装置(6)保持在保持着所述预定量的能量的状态,以及设置致动装置(35)用来将所述预定量的能量从所述能量储存装置(6)上释放出来。
8.如权利要求1-5中任一项所述的计量剂量吸入器,其特征在于:所述能量储存装置(6)操作一个活塞(3;52),该活塞(3;52)被安置来对该腔室(4)作用以便对所计量的液体进行加压。
9.如权利要求8所述的计量剂量吸入器,其特征在于:所述能量储存装置(6)是由一个弹簧加载泵机构(3,4,13,23;52,55,54,56)构成的,而所述腔室(4;55)提供来作为该泵机构内超出该泵活塞(3;52)之外的气缸空间。
10.如权利要求9所述的计量剂量吸入器,其特征在于:该泵机构(3,4,13,23)设置有一个机构(33),借此,在将所述预定的能量从弹簧(6)上释放出来之前将该泵保持在击发状态。
11.如权利要求8所述的计量剂量吸入器,其特征在于:所述活塞(52)是空心的,从而提供了一个用于使液体进入该腔室(55)内的通道。
12.如权利要求11所述的计量剂量吸入器,其特征在于:该通道设置有一个用于该腔室(55)的不可逆输入阀装置(54)。
13.如权利要求11所述的计量剂量吸入器,其特征在于:该活塞(52)从液体蓄积器(51)延伸出。
14.如权利要求1-5中任一项所述的计量剂量吸入器,其特征在于:该计量剂量吸入器包括一个液体蓄积器(10;16;51),所述腔室(4,55)可从该液体蓄积器中装入液体。
15.如权利要求13所述的计量剂量吸入器,其特征在于:所述蓄积器(10;51)是可替换的。
16.如权利要求13所述的计量剂量吸入器,其特征在于:所述蓄积器(10;51)是可压扁的。
17.如权利要求1-5中任一项所述的计量剂量吸入器,其特征在于:所述腔室是一个容积可变的腔空(4;55;75),其带有不可逆输入阀装置(13,54;74)和不可逆输出阀装置(23,56;76),以便能将液体重复加入所述腔室(4;55;75)以及将液体从所述腔室(4;55;75)中排出。
18.如权利要求1-5中任一项所述的计量剂量吸入器,其特征在于:所述雾化装置(22;57;80)包括一个出口孔(104)和一个撞击体(106),该出口孔(104)安排来形成液体的喷流(102),而该撞击体(106)位于液体喷流(102)的轨道线上并安排来将液体喷流(102)撞碎成雾滴。
19.如权利要求1-5中任一项所述的计量剂量吸入器,其特征在于:所述雾化装置(22;57;80)设计成能提供互相撞击的液体喷流(110)以形成雾滴。
20.一种采用如权利要求1中所述计量剂量吸入器来排放一定计量的雾滴液体的方法,该方法包括下列步骤:
在一个能量储存装置(6)上施加预定量的能量并且保持该能量,在将此预定量的能量施加到所述能量储存装置上的过程中可使一个腔室(4;55;75)内的压力降低到能使一定计量的液体进入到所述腔室(4;55;75)内;
在散布雾滴液体时,将储存在所述能量储存装置(6)上的预定量的能量施加到所述腔室(4;55;75)中使得所述一定计量的液体可从低压增加预定的压力达到50巴或者更高的较高压力,从而使所述一定计量的液体从所述腔室(4;55;75)以所述较高的压力排放出来。
使以所述较高的压力排放出来的所述一定计量的液体通过一个雾化装置(22;57;80)以雾滴液体的形式散布出来,其中所述雾滴液体的尺寸大小使得其适合于吸入肺中。
21.如权利要求20所述的方法,其特征在于:所述较高的压力是100巴或者更高。
22.如权利要求20或21所述的方法,其特征在于:所述雾滴具有100微米或更小的平均颗粒尺寸。
23.如权利要求20所述的方法,其特征在于:该方法还包括下列步骤:
用能量施加装置(3,31,32,34)将预定量的能量施加到所述能量储存装置(6)上;和
用能量释放装置(33,35)将所述预定量的能量从所述能量储存装置(6)释放到所述腔室(4;55;75)内,以便使液体压力从较低的压力增加预定的量达到较高的压力,从而使所述一定计量的液体开始从所述腔室(4;55;75)中排放出。
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GB9006340.5 | 1990-03-21 | ||
GB909006340A GB9006340D0 (en) | 1990-03-21 | 1990-03-21 | Metered dose aerosol delivery system |
GB909023767A GB9023767D0 (en) | 1990-11-01 | 1990-11-01 | Atomising devices and methods |
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