CN1213974A - 吸入器具 - Google Patents
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Abstract
一种粉末吸入器具,它包括其内含有一种药理上有效的混合物或药物的壳体、一延伸到壳体内并带有一出口的通道(8)、一向通道分配化合物剂量的计量单元(6、7)以及设置在所述通道内帮助破碎夹带在气流中的粉末团的阻流板(9),使用者通过通道吸药物,以形成通过通道的气流,阻流板(9)包括多个交错排列的板,这些板从通道的两相对侧延伸到通道内,它们与通道侧的夹角小于90°,并朝向出口倾斜,在通道内形成多个收缩,并使通过通道的所述空气流的方向多次改变。
Description
本发明涉及一种吸入器具，借助于这种吸入器具可以将以粉状形式的计量药剂分配给使用者。
已知吸入器具是用于病人呼吸道或肺的药物局部服用的。在英国专利文件GB2178965中描述了这样一种称之为DISKHALER吸入器的器具，这种器具与泡状包结合使用，粉末状药物保持在泡状包中。在使用时，将新的泡状包对准使用部位，然后用一刺穿件通过两个特殊的动作刺破泡状包，使药物能从泡状包中被吸入。
另一种吸入器具在英国专利文件GB2242134中予以描述，这种吸入器具结合可剥离的药包使用，该药包中有几个容纳药物的容器，该吸入器具包括一用于剥开药包的器件，当各容器对正使用部位时剥离件依次打开各容器。这种器具多少有些复杂，并且包含很多部件。
通过吸入服用的药物应该具有控制的粒度，以便获得最大的穿入肺部的效果，优选的粒径为1至10微米，更优选为1至5微米。不幸的是，在这样的粒度范围内的粉末(后面称之为细粉末)，例如微粒化的粉末的流动特性通常非常差，这是因为各颗粒之间具有粘合力，该力使得它们很容易结团架桥，而这些桥不易破开形成自由流动。这些特性造成了处理和计量的困难，而处理和测量的困难又反过来影响粉末剂量的精确分送。然而，共同未决的PCT专利文件EP96.03274描述了如果通过仔细选定细小结团颗粒的尺寸，能够利用颗粒之间的粘合力形成自由流动的粉末团。这些粉末团很容易处理，并且可以很便利地用来将这些粉末团充填于器具。
然而，为了向肺中有效的发送，必须在粉末团离开器具之前将其破碎成一种控制的尺寸。
已经发现，如果在粉末吸入器具的嘴部装有一系列阻流板，当使用者吸入时就能将粉末团在汽流中破碎。专利文件EP0237507描述了包括有螺旋通道部分的阻流板，这种阻流板使气流具有旋转螺旋的运动方式。
然而，专利文件EP0237507中的一个缺点是阻流板包括多个部件，这就使得器具制造过程相对复杂和昂贵。
专利文件GB2191718涉及用于分发尼古丁的烟雾器。尼古丁分发器有一设计成分离喷雾的冲击件，使较小的颗粒和蒸汽相围绕阻流板流动，而将较大的颗粒去除。
专利文件PCT/EP93/00582也描述了一种包括阻流板的器具，阻流板用作分离器，如果烟雾中含有较大的颗粒，这些颗粒呈较松散的团的形式，则当它们以足够高的速度冲击阻流板时，这些颗粒团的尺寸就能减小。
在专利文件GB2191718和PCT/EP93/00582中描述的这两组阻流板的缺点是存在大量的粉末沉积，由于阻流板以与气流的流向成90°的方向从器具的壁延伸出，所以这种情况是有可能发生的。这可能会导致更大的粉末团沉积的发生，这种团在后面的吸入中会变松，从而导致剂量的变化。
本发明的一个目的是提供一种刚刚描述过的器具，它易于使用者操作，并且组装起来不过分复杂。本发明的进一步的目的是提供一种器具，它可以充以粉末团，但是发送的却是适合于通过吸入服用的粉末。
按照本发明提供一种吸入器具，它包括一壳体；一出口，使用者可以通过该出口吸入药物；一限定至少一个窝腔的药物容纳器，该窝腔容纳一次剂量的粉末状药物；一封闭件，其具有至少一个由弹性力压迫与药物容纳器接触以封闭至少一个所述窝腔的封闭垫；用于将窝腔移动到与出口对正的位置的装置；以及用于当窝腔与出口对正时提升封闭垫，使其离开药物容纳器，以便打开窝腔的装置。
这种器具易于操作，只需一个特殊的动作就可从中吸入药物。这种器具还可以包括较少的部件。
按照本发明，还提供一种粉末吸入器具，它包括其内含有一种药理上有效的混合物或药物的壳体、一延伸到壳体内并带有一出口的通道、一向通道分配化合物剂量的计量单元以及设置在所述通道内帮助破碎夹带在空气流中的粉末团的阻流板，使用者通过通道吸药物，以产生通过通道的气流，其特征在于：阻流板包括多个交错排列的板，这些板从通道的两相对侧延伸到通道内，与通道侧的夹角小于90°，并朝向出口倾斜，以在通道内形成若干收缩，并使通过通道的所述气流的方向发生多次改变。
通过使用这种结构，可以提供易于制造的阻流板，并使粉末在板上的沉积少，这种隔板在将结团破碎成不连续构成的颗粒以形成可吸入大小的粉末方面具有良好的效果。
这种器具优选具有至少两块板，更优选具有四块板。
优选使所述板相对于通道的纵轴线在空气流方向的倾角小于70°，更优选使该倾角在15°至50°之间。
倒数第二块阻流板取如下形状是适合的，该板沿其上某些点划分成至少两面，第一面连续延伸到通道内，而第二面基本上平行于通道的纵轴线向着出口延伸。这使得空气流能够平行于所述轴线排出，将药物直接喷入使用者的呼吸道，而不是进入其面颊腔。
下面参考附图进一步描述本发明的一实施例，其中：
图1是按照本发明的一组装的装置的透视图；
图2是图1所示装置的一分解透视图，图中示出主体部件和基本组件；
图3是一分解透视图，以拆开的形式示出各部件；
图4是一部分剖开的平面视图，示出通过本发明的一优选实施例的空气流；
图5是一透视图，示出通过图4所示装置的空气流；和
图6是一剖视图，示出窝封闭垫处于提起的位置。
图1至3所示的装置包括一主体1，它由一主体基部2和一主体顶部3构成，二者都可由一种比如丙烯酰丁基丙乙烯(acryl-butylstyrene)(ABS)的塑料材料模塑而成。主体顶部3上形成有一窗口4，其目的下面将要描述。主体1限定一适合于容纳一基本组件的主壳体部分和一嘴部8，基本组件包括一剂量环6和辐射架形式的封闭件7；嘴部8形成一从主壳体部分径向延伸出的出口，使用者可以通过该出口吸入药物。从图2中可以看出，主体基部2的嘴部8上形成有多个阻流板9，后面将对此作出解释。
一以盘或剂量环6形式的药物保持器包括一上表面，其上形成若干腔室或窝腔10，用于容纳需要从器具中分发的可吸入粉末状药物。每个窝腔10由一凸唇(未示出)所围绕。所示的剂量环上设有十个窝腔10，这十个窝腔可能适合于容纳十天的药量，也可能容纳足够一个疗程的药量。应当理解，剂量环可能带有多一些或少一些的窝腔，这取决于需容纳的药物量。适用的粉末状药物为，例如用于治疗气喘的药，包括舒喘灵、二丙酸氯地米松、沙美特罗、氟替卡松、福莫特罗、叔丁喘宁、丁地去炎松和9-去氟肤轻松，以及生理上可接受的盐、溶剂化物和酯或其任何组合。优选的药物为舒喘灵、硫酸舒喘灵、沙美特罗、克赛纳弗盐沙美米特罗(xinafoate salmeterol)、丙酸氟替卡松(fluticasonepropionate)、丙酸盐二丙酸氯地米松或其溶剂化物和硫酸盐叔丁喘宁。其它适用的粉末状药物包括抗病毒药物，例如匝纳米维亚(zanamivir)(4-胍-Neu-5-Ac-2-en)。熟悉本领域的技术人员可以理解，如果需要的话，粉末状药物可以是两种或多种有效成分的组合。一次的剂量可以包含一个或多个腔室的含量，腔室的大小取决于需分发的剂量。应该理解药物粉末可以纯粹由一种或多种有效成分构成，也可以有附加载体，例如乳糖粉。
按照在共同未决的PCT专利申请EP96.03274中描述的方法和装置，剂量环6中可以充以成团状的粉末。
剂量环6具有一阶梯状的周边，其目的将在后面予以描述，其中心具有一花键孔，用于与辐射架7接合。剂量环也可以由一种塑料，例如ABS模塑而成。
辐射架7包括一中心环形部分11，多个弹性径向臂12从该部分伸出，弹性径向臂的数量对应于剂量环6中的窝腔10的数量。各径向臂12的端部是一窝腔封闭垫13。多个短弹性钩状薄片14从中心环形部分11沿轴向伸出，并适合于通过与剂量环6中心的花键孔相接合形成一种与剂量环6的咬合连接。辐射架7可以由一种塑料材料模塑而成，例如聚碳酸酯或其它具有所需弹性特征的工程塑料。当辐射架7与剂量环6组装成一剂量元件或基本组件时，钩状薄片14与剂量环6上的花键孔紧密接合，弹性径向臂12的弹性力迫使各窝腔封闭垫13与剂量环6的上表面上的相应的凸起接触，盖住并密封相应的窝腔10，以防止药物从窝腔中逸出以及湿气浸入窝腔。窝腔封闭垫上可以模塑出一直接密封在剂量环6或凸唇28上的光滑平接触面(见图6)，也可以设置一种在接触面上形成的热塑弹性体一类的软的密封材料，例如SANTOPRENE(拜尔)，来改善密封特性。为了制造窝腔封闭垫上带有不同的密封材料的辐射架，在辐射架上可以模塑出一通道15，该通道形成于中心环形部分11的上表面和各径向臂12内，并模塑出一小孔(未示出)，该孔从各径向臂12内的通道15的端部通向窝腔封闭垫13的下侧。然后可以使一种熔融状态的密封材料环通道15流动，并通过孔流到各窝封闭垫13的下侧，以便在冷却后在各垫上形成一种整体垫密封。
窝腔封闭垫13的上表面可以模塑出或印上一数字17或其它指示装置，指示在器具中有多少剂量的药，这在下面将更详细地解释。
在各窝腔封闭垫13的边缘上形成一适合于与主体顶部3整体形成的一斜面20(见图4和5)接合的突舌16，以影响窝腔的开启，这在后面将予以解释。
基本组件安装在主体1的主壳体部分内，如图2和3所示，使主体基部2的轴21位于基本组件的孔内，剂量环的阶梯周边穿入主壳体部分的相对侧上的两隔开部分内。主体基部2上的爪24与剂量环6的下侧上的齿(未示出)接合，以形成一种只允许剂量环在一个方向上运动的棘轮机构。
窝腔10中可以充填在PCT专利申请PCT EP96.03274中描述的成团状粉末。当这样充填时，对于吸入治疗，基本上是最大可能的吸入基本颗粒量处在可吸入的范围内，该范围小于5微米。为了帮助破碎夹带在空气流中的任何粉末团，在嘴部8中装有一系列阻流板9。后面将要解释，阻流板的位置是很重要的。阻流板可以与主体模塑成一整体，从而能够承受一致的、受控的和可重复的容许极限。可以理解，阻流板的数量和精确尺寸取决于所用的粉末和将粉末团保持在一起的力的大小。例如，已经发现，四个阻流板达到所需的匝纳米维亚(zanamivir)粉末团的破碎。对于熟悉本领域的技术人员来说，很容易对阻流板的尺寸进行实验，以对特定粉末获得所需的流动阻力。
图4和5示出一种阻流板9的优选结构，这种阻流板包括多个交错排列的平板，它们以相对于通道的纵轴线成30°的角度从壳体的相对侧延伸到通道内。多数阻流板超过通道的纵轴线，而最后的阻流板25在空气流动方向上终止于不到轴线处。倒数第二个阻流板26在空气流动方向上具有一平行于通道的纵轴线向着出口延伸的平面27。这使得气流平行于所述轴线流出，直接将药粉发送到使用者的呼吸道内，而不是使用者的面颊腔部。
一嘴盖22适用于当器具不使用时盖住嘴部8，以防止嘴部被灰尘污染。嘴盖带有两个销钉30，它们适合于通过两个槽23穿入主壳体1上的嘴部8的两侧与剂量环的阶梯状周边接合，并从而锁定基本组件，防止器具不使用时的意外移动。要使用器具时，适用者首先要去掉嘴盖22，从而将基本组件解锁。然后使用者通过使剂量环上凸出于主壳体部分上的切开部分之外的阶梯状周边相对于主体1转动剂量环6找到一个窝腔，将其与嘴对正。上面描述的棘轮机构使基本组件只能在一个方向上转动。当基本组件旋转时，下一个窝腔封闭垫13上的突舌16与斜面20接合，当突舌跨在斜面上时，将窝腔封闭垫13提升，使其离开剂量环6的上表面。当窝腔与嘴对正时，围绕着窝腔10的凸唇28(见图6)与出口通道29的侧壁接合，形成对剂量环的运动的增大的阻力，从而清楚地告诉使用者，剂量环已经处于准备发送药物的位置。
当围绕着窝腔10的凸唇28与出口通道29接合时，窝腔封闭垫13处于离开剂量环6的上表面的一升高的位置，如图6所示。在该位置，窝腔封闭垫13直接位于主体顶部3中的窗口4的下面，因此模塑或印在窝腔封闭垫13的上表面上的数字17或其它剂量指示装置可以在窗口4上清楚地看出。这使得使用者看到在器具内还有多少剂药。
现已经准备好发送在窝腔10中所含的药物。使用者通过嘴8吸入。空气通过槽3吸入器具并被引导到窝腔10的上方，如图4和5所示。当空气流过窝腔10时，窝腔中的药粉被空气流中的旋涡夹带，通过嘴部8吸走，并被使用者吸入。
从图5中看出，设置阻流板9是为了破坏空气穿过嘴部的光滑流动，以形成附加的旋涡，使得空气流几次变化方向，从而引起任何粉末团冲击阻流板、壁和其它团，并使空气流收缩，以提高流速。空气循环产生阻流板回流中的涡流，引起进一步的碰撞，帮助粉末团的破碎。图5中表示空气流动的箭头示出这种情况。所有这些作用都促进了空气流中夹带的粉末团的破碎，使粉末具有适合于吸入治疗的形式。平行于通道的纵轴线在空气流动方向上延伸并连接于导数第二阻流板的平面27使空气流能够平行于所述轴线离开嘴部，直接将粉末发送到使用者的呼吸道中，而不是使用者的面颊腔中。
吸入以后，使用者重新盖上嘴盖22，保护并锁闭器具，直到需要吸入下一剂药。
应该理解，本公开只是为了说明的目的，本发明延伸到对其作出的改善、变化和改进。
Claims (27)
1．一种吸入器具，它包括一壳体；一出口，使用者可以通过该出口吸入药物；一限定至少一个窝腔的药物容纳器，该窝腔容纳一次剂量的粉末状药物；一封闭件，其具有至少一个由弹性力压迫与药物容纳器接触以封闭至少一个所述窝腔的封闭垫；用于将窝腔移动到与出口对正的位置的装置；以及用于当窝腔与出口对正时提升封闭垫，使其离开药物容纳器，以便打开窝腔的装置。
2．一种如权利要求1所述的器具，其特征在于：所述药物容纳器包括一可旋转地安装在器具内的盘，至少一个窝腔设置在所述盘的一面上。
3．一种如权利要求1或2所述的器具，其特征在于：各所述封闭垫受到一相应的弹性臂的弹性压迫与药物容纳器接触。
4．一种如权利要求3所述的器具，其特征在于：其包括若干封闭垫，封闭件包括多个弹性臂，它们以辐射架的形状连接在一起。
5．一种如权利要求4所述的器具，其特征在于：所述辐射架由聚碳酸酯制成。
6．一种如前述任一权利要求所述的器具，其特征在于：所述封闭垫包括一种热塑弹性体。
7．一种如权利要求2至6中任一项所述的器具，其特征在于：所述盘从器具的主体中凸出，以提供用于移动至少一个窝腔，使其与出口对正的装置。
8．一种如权利要求7所述的器具，其特征在于：所述盘的周边上带有抓手。
9．一种如权利要求7或8中任一项所述的器具，其特征在于：其还包括一棘轮机构以便只允许盘沿一个方向运动。
10．一种如前述任一权利要求所述的器具，其特征在于：窝腔封闭垫通过与一斜面接合而提高，离开所述盘的表面。
11．一种如前述任一权利要求所述的器具，其特征在于：其还包括一可卸下的嘴盖，当它盖住时与药物容纳器接合，以防止其运动。
12．一种如前述任一权利要求所述的器具，其特征在于：出口包括一通道，其内设置多个交错排列的板，这些板以相对于通道侧小于90°的倾角从通道的两相对侧伸入通道内，并且这些板向出口倾斜，以在通道内形成多个收缩，并多次改变通过通道的气流的方向。
13．一种如权利要求12所述的器具，其特征在于：包括至少两个板。
14．一种如权利要求13所述的器具，其特征在于：包括四个板。
15．一种如权利要求12至14中任一项所述的器具，其特征在于：所述板在气流的方向上相对于通道的纵轴线的倾角小于70°。
16．一种如权利要求15所述的器具，其特征在于：所述板以15至50°的角度倾斜。
17．一种如权利要求16所述的器具，其特征在于：所述板以30°角倾斜。
18．一种如权利要求12至17中任一项所述的器具，其特征在于：倒数第二个板取这样的形状，在沿板的某些点上它划分成至少两个面，第一面连续延伸到通道内，而第二面基本上平行于通道的纵轴线向出口延伸。
19．一种如前述任一权利要求所述的器具，其特征在于：所述窝腔中充以药物。
20．一种粉末吸入器，它包括其内含有一种药物的壳体、一延伸到壳体内并带有一出口的通道、一向通道分配化合物剂量的计量单元以及设置在所述通道内帮助破碎夹带在气流中的粉末团的阻流板，使用者通过通道吸药物，以产生通过通道的气流其特征在于：阻流板包括多个交错排列的板，这些板从通道的两相对侧延伸到通道内，其与通道侧的夹角小于90°，并朝向出口倾斜，在通道内形成多个收缩，并使通过通道的所述气流的方向多次改变。
21．一种如权利要求20所述的器具，其特征在于：包括至少两个板。
22．一种如权利要求21所述的器具，其特征在于：包括四个板。
23．一种如权利要求20至22中任一项所述的器具，其特征在于：所述板在气流的方向上以相对于通道的纵轴线小于70°的倾角倾斜。
24．一种如权利要求23所述的器具，其特征在于：所述板以15至50°的倾角倾斜。
25．一种如权利要求24所述的器具，其特征在于：所述板以30°倾角倾斜。
26．一种如权利要求20至25中任一项所述的器具，其特征在于：倒数第二个板取这样的形状，在沿板的某些点上它划分成至少两个面，第一面连续延伸到通道内，而第二面基本上平行于通道的纵轴线向出口延伸。
27．一种如前述任一权利要求所述的器具，其特征在于：其中的药物为匝纳米维亚(zanamivir)。
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| GB9600044.3 | 1996-01-03 | ||
| GBGB9600044.3A GB9600044D0 (en) | 1996-01-03 | 1996-01-03 | Inhalatiion device |
| GBGB9625134.3A GB9625134D0 (en) | 1996-12-03 | 1996-12-03 | Powder inhalation device |
| GB9625134.3 | 1996-12-03 |
Publications (1)
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|---|---|
| CN1213974A true CN1213974A (zh) | 1999-04-14 |
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| CN96180172A Pending CN1213974A (zh) | 1996-01-03 | 1996-12-19 | 吸入器具 |
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| EP (2) | EP0938907B1 (zh) |
| JP (1) | JP2000503565A (zh) |
| KR (1) | KR19990077014A (zh) |
| CN (1) | CN1213974A (zh) |
| AP (1) | AP9801285A0 (zh) |
| AT (2) | ATE209939T1 (zh) |
| AU (1) | AU725348B2 (zh) |
| BR (1) | BR9612410A (zh) |
| CA (1) | CA2241880A1 (zh) |
| CZ (1) | CZ212598A3 (zh) |
| DE (2) | DE69618624T2 (zh) |
| EA (2) | EA001016B1 (zh) |
| ES (2) | ES2166473T3 (zh) |
| IL (1) | IL125183A0 (zh) |
| IS (1) | IS4787A (zh) |
| MX (1) | MX9805409A (zh) |
| NO (1) | NO983069L (zh) |
| NZ (1) | NZ324374A (zh) |
| PL (1) | PL327616A1 (zh) |
| TR (1) | TR199801265T2 (zh) |
| WO (1) | WO1997025086A2 (zh) |
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- 1996-12-19 AP APAP/P/1998/001285A patent/AP9801285A0/en unknown
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| Publication number | Priority date | Publication date | Assignee | Title |
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| CN103252007A (zh) * | 2008-06-13 | 2013-08-21 | 曼金德公司 | 干粉吸入器和用于药物输送的系统 |
| CN103252007B (zh) * | 2008-06-13 | 2016-06-22 | 曼金德公司 | 干粉吸入器和用于药物输送的系统 |
| CN103764210A (zh) * | 2011-08-19 | 2014-04-30 | 阿普塔尔法国简易股份公司 | 粉末吸入设备 |
| CN103764210B (zh) * | 2011-08-19 | 2016-07-06 | 阿普塔尔法国简易股份公司 | 粉末吸入设备 |
| CN109310834A (zh) * | 2016-04-18 | 2019-02-05 | 励志私人有限公司 | 用于吸入器的间隔装置 |
| CN106075677A (zh) * | 2016-08-08 | 2016-11-09 | 中山市美捷时包装制品有限公司 | 一种干粉吸入装置的促动机构 |
| CN110799230A (zh) * | 2017-06-27 | 2020-02-14 | 韩国联合制药株式会社 | 干燥粉末吸入器 |
| CN110799230B (zh) * | 2017-06-27 | 2022-04-05 | 韩国联合制药株式会社 | 干燥粉末吸入器 |
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