CN105381524A - 吸入设备和方法 - Google Patents
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Abstract
本发明提供了将药物输送到人或者动物病患的气道的方法和设备。一方面,该设备包括形成为圆柱体的剂量圆筒,并包括用于容纳单独的剂量的多个剂量隔室。另一方面,该设备可以包括容纳团块形式的药物材料的储存器,和用于计量药物材料以形成药物剂量的计量凹座。再一方面提供了具有组合的储存器和剂量室的吸入器,其配置为容纳药物材料的多个剂量。
Description
技术领域
本发明通常涉及吸入设备领域。本发明具有特别是与使用干粉吸入器将粉末状药物输送给患者有关的应用,并且本发明之后将通过此类应用进行描述,不过也可考虑其他的应用。
背景技术
已知某些呼吸道疾病通过直接施加治疗剂来治疗。由于这些药剂最容易以干粉形式获得,所以通过鼻或口吸入这些粉末状材料来完成其应用是最方便的。粉末形式使得药剂得到更好的利用,因为药物被准确放置在期望的并且需要它起作用的位置。因此,非常小剂量的药物常常与采用其他方式给药的大剂量的药物同样有效,同时显著减少了不希望有的副作用的发生率和药物成本。可选地,这种形式的药物还可以用于治疗除了呼吸系统疾病之外的其他疾病。当药物被放置在肺的很大的表面区域上时,它可以快速地被吸收到血流中。因此,这种应用方法可以替代通过注射、药片或其他的传统方法的给药。
制药工业的意见是,当被传送到呼吸道的药物颗粒的尺寸在1至5微米时,药物的生物利用度是最佳的。当药物颗粒需要在该尺寸范围时,干粉输送系统必须解决大量问题:
(1)小尺寸的颗粒可能在制造和贮存时在其上产生静电电荷。这可能导致颗粒成团或聚集,产生有效尺寸大于5微米的颗粒簇。这些较大的颗粒簇深入到肺里的可能性减小。这就相应导致患者可吸收的包装药物的百分比下降。
(2)需要输送给患者的活性药物量可能大约为数十微克。例如,就用于哮喘的药物舒喘宁而言,其通常是25到50微克。现在的制造设备可以在毫克剂量范围内以可接受的精度有效地输送药物的等分部分。因此,常规作法是将活性药物与填料或填充剂例如乳糖混合。该添加剂还使得药物"易于流动"。这些填料还被称为载体,因为药物颗粒还可以通过静电或化学连接粘接到这些颗粒上。这些载体颗粒在尺寸上比药物颗粒大很多。干粉吸入器从载体中分离药物的能力在设计功效中是重要的性能参数。
(3)具有大于5微米的尺寸的活性药物颗粒将很可能被放置在口中或者咽喉中。这引入了另一个不确定的标准,因为药物在这些位置的生物利用度和吸收不同于肺。干粉吸入器需要最小化在这些位置沉积的药物以降低与药物的生物利用度相关的不确定性。
现有的干粉吸入器(DPI)通常具有用于将药物(活性药物加载体)引入到高速气流中的装置。高速气流作为用于破碎微粉化颗粒簇或从载体分离药物颗粒的主要机制。在现有技术中已知有几种用于分配该粉末形式的药剂的吸入设备,例如,在美国专利号3,507,277;3,518,992;3,635,219;3,795,244;以及3,807,400中,公开了吸入设备具有用于刺穿包含粉末状药剂的胶囊的装置,当吸入时,粉末状的药剂从刺穿的胶囊出来并且进入到用户的口里。这些专利中的几篇专利公开了推进装置,其在吸入时有助于从胶囊中分配粉末,因此它不必仅依赖吸入空气以从胶囊中吸取粉末。例如,在美国专利号2,517,482中,公开的设备具有在吸入之前放置到下部腔中的包含粉末的胶囊,用户通过手动压下刺穿销刺穿来刺穿胶囊。在刺穿之后,开始吸入并且胶囊被吸取到该设备的上部腔中,其中胶囊在各个方向上移动以促使粉末通过刺穿的孔进入到吸入气流中进行分配。美国专利号3,831,606公开的吸入设备具有多个刺穿销、推进装置和独立电源,用于通过外部手动操纵来操作推进装置,因此在吸入时推进装置有助于将粉末分配到吸入空气流中。也可参见美国专利号3,948,264和5,458,135。
在转让给共同的受让人MicroDoseTechnologies,Inc.的通过引用而结合到本文中的之前的美国专利7,318,434、7,334,577和7,779,837中,提供了对现有技术吸入器的改进,其利用振动以促进粉末悬浮物进入到吸入气流中的,并利用合成喷射流从泡罩包装等中雾化药物粉末。如上述的美国专利7,318,434、7,334,577和7,779,837所教导的,提供了一种干粉吸入器,其具有用于容纳干粉的例如为泡罩包装或其他的容器的第一腔,以及通过通道与第一腔连接的用于接收来自第一腔的雾化形式的干粉并且将雾化状干粉传送给使用者的第二腔。振动器在第一腔中与干粉连接。振动器通电并与第一腔连接,通过合成喷射流驱动来自腔中的粉末。
如同样转让给共同的受让人MicroDoseTechnologies,Inc.的通过引用而结合到本文中的的美国专利7,080,644所述,受控的药物或药品的等分部分或剂量预封装在泡罩包装中,其包括易碎的冠状顶部元件和底部元件,该冠状顶部元件可以是圆锥形、带有圆点的圆锥形、圆形或其他的凸起形状的结构,该底部元件可以是平面网或薄膜,或者其本身可以是具有特定形状的结构,例如圆锥形、圆形和盘状等,用于紧密地啮合在下的振动元件,选择其形状和尺寸以提供给定药物或药品的最佳的受控输送。泡罩包装的顶部元件利用穿刺设备例如锋利的针刺穿以形成一个或多个孔,用于输送包含在泡罩包装内的药物或药品。孔的图案和孔的尺寸是经过挑选的以使封装在其中的药物或药品的输送最优化。
发明内容
本发明一方面提供了对现有技术设备例如上述讨论的设备的改进,通过提供紧凑尺寸的药物输送包装,将药物输送到人或动物病患的气道,包括多个单独剂量的药物。输送包装包括圆柱体形式的剂量圆筒,该剂量圆筒包括用于容纳单独剂量药物的多个剂量隔室,输送包装还包括用于围绕剂量圆筒的护套,因此在剂量隔室中容纳和隔离多个单独剂量的药物。药物输送包装可以形成为围绕剂量圆筒的外表面紧密配合,其中护套具有至少两个孔,包括用于利用药物填充剂量隔室的第一孔和用于允许输送所述多个单独剂量的药物中的一个的第二孔。可替换地,护套可以由带或薄片形成,该带或薄片是可剥离或刺穿的,以获取容纳在其中的药物剂量。
另一方面,本发明提供了一种将药物输送到人或动物病患的气道的吸入器。该吸入器包括形成为圆柱体的剂量圆筒,该剂量圆筒包括多个剂量隔室以容纳单独剂量的药物;围绕剂量圆筒的护套;剂量室;和流道,由此单独的剂量输送到病患的气道。剂量室可以是与振动设备例如压电器件连接的谐振腔。吸入器还可以包括用于推进剂量圆筒的驱动器,因此单独的剂量可以装载到剂量室中。
另一方面,本发明提供了一种将药物材料输送到人或动物病患的气道的方法,该方法包括将药物材料提供到与计量装置连接的储存器中的步骤。利用计量装置计量药物材料以形成单个药物剂量;将单个药物剂量移动到剂量室中;分离单个药物剂量的药物材料;从剂量室将单个药物剂量通过流道输送到病患的气道。
另一方面,本发明提供了一种将药剂输送到人或动物病患的气道的吸入器。吸入器包括容纳块状的药物材料的储存器,用于计量药物材料以形成药物剂量的计量凹座;剂量室和连接到剂量室的流道,药剂从剂量室通过流道输送到病患的气道。计量凹座可以设置在计量圆筒的外表面,计量圆筒旋转以加载计量凹座并将药物剂量加载到剂量室中,计量圆筒由护套围绕。可替换地,计量凹座可以封闭在第一计量门和第二计量门之间。储存器可以是圆柱体的形状,储存器具有用于将药物加载到凹座中的压缩弹簧和活塞。
另一方面,本发明提供了一种将药物材料输送到人或动物病患的气道的吸入器,该吸入器包括带有室密封和流道的剂量室。剂量室的尺寸可以容纳多个剂量的药物材料。剂量室可以是与振动设备连接的谐振腔。室密封可以连接到加压源,例如氮室或真空。可替换地,室密封可以连接到干燥源。
再一方面,本发明提供了一种将单个剂量的药物材料输送到人或者动物病患的气道的方法。多个剂量的药物材料容纳在谐振腔中。药物材料利用与谐振腔连接的振动设备分解,从而促使合成喷射流排出一些药物材料。药物材料的输送是通过控制振动设备的持续运行时间计量的,也可以通过最优化振动设备的振动频率控制。
再一方面,本发明提供一种可重复使用的药筒形式的药物输送包装。药筒包括形成在基底材料上的气泡带,其中形成一系列的凹陷或孔穴以容纳单独剂量的药物。薄片放置在基底之上以密封用于形成单个气泡的单个凹陷。药筒还包括用于分离单独剂量的药物的气雾室和相对于气雾室用于推进气泡带的设备。用于推进气泡带的设备包括一个或多个臂、弹簧、凸轮、齿轮或轮子。气泡检测开关帮助控制气泡带的推进,以不断地相对于气雾室定位单独的气泡。药筒还包括用于在气泡带相对于气雾室移动时将薄片从气泡带移除的设备。药筒还包括接口和流道,流道连接气雾室和接口。
另一方面,本发明提供了一种将药物输送到人或动物病患的气道的吸入器,其利用如上所述的药筒。吸入器包括用于振动设备和电机的壳体。药筒应当形成环形,气泡带容纳在环中。壳体包括进气口和压力传感器,进气口连接或配合药筒的流道。O型环等可用于密封进气口和流道之间的连接。振动设备,其可以是压电器件,与药筒的气雾室连接。气雾室可以形成谐振腔。电机还与药筒连接,提供能量以驱动用于推进气泡带的设备和用于移除薄片的设备。
再一方面,本发明提供了一种自动地将药物输送到人或动物病患的气道的吸入器。该吸入器包括容纳至少一个剂量的药物、压力传感器、振动设备和气雾室的壳体。壳体连接到用于将药物输送给病患的接口,病患通过它呼吸。
附图说明
结合附图,可以从下列详细说明中看出本发明其他的特征和优点,其中:
图1A-D是显示了本发明的药物输送包装和吸入器的视图;
图2是根据本发明的一个实施例的剂量圆筒的视图;和
图3A-C是在本发明的可替换的实施例中的药物输送包装和吸入器的视图;
图4是根据本发明的另一个实施例的药物输送包装和输送装置的视图;
图5是根据图4中所示实施例的气泡带;
图6A、6B和6C是图4所示的药物输送包装的剖面图;
图7A、7B、7C和7D;8A、8B和8C;9A和9B;以及10A、10B和10C是装配在一起的图4的药物输送包装和设备的剖面图;
图11A和11B显示了根据本发明的吸入设备的不同视图;
图12A和12B显示了根据本发明的另一吸入设备的不同视图;
图13是根据本发明的另一个实施例的药物材料输送包装和吸入器的视图.
具体实施方式
在下面的说明书中,参照的附图构成了说明书的一部分的附图,其中示意性的示出了本发明的多个实施方式。可以理解的是,可利用其它实施方式并在不背离本发明的范围的情况下对其作出改变。
本发明提供了一种改进的吸入设备和方法,用于将药物输送到病患的气道。预计的病患可以是人或者动物,因此吸入设备应当相应设计。吸入器将结合干粉吸入器进行讨论,但是可预见的是本发明还可以应用于其他类型的吸入器。
第一方面,本发明提供了用于输送不连续剂量的药物的包装,其中单独的剂量被分隔到在圆柱形剂量圆筒上安置的单独隔室中。单独的剂量可以是储存在单独的气孔中,例如在共同拥有的美国申请11/425,097中所描述的,其通过引用结合到本文中。单独的剂量也可以封装在薄膜之间或者在薄膜和基底之间,其可以由或者不由预成型的微凹或其他的凹口形成,以形成隔室的一部分。
单独的隔室设置在圆柱形剂量圆筒上,该剂量圆筒包括圆柱形的基底,剂量圆筒具有内表面和外表面。容纳单独剂量的药物的隔室可以形成在基底的内表面上或者基底的外表面上。可替换地,形成的隔室可以从基底至少部分地在内表面和外表面上凸出。基底可以是由任何适当的材料制造,例如塑料,陶瓷,纸张或金属材料,外表上可以从透明到不透明。
在本发明所述方面的一个实施例中,剂量圆筒由配置成具有凹座设置的圆柱体的基底材料形成,各个凹座包括构造成从基底朝向剂量圆筒的中心凸出的凹陷。单独的剂量隔室由凹座形成并通过护套约束。参考图1A-D,形成的护套20可以根据紧密公差装配在剂量圆筒10上,以充分隔离单独的剂量隔室12。在这点上,护套可以包括围绕剂量圆筒的紧密配合套,用于在各自的剂量隔室中包括每个剂量,并且提供防潮层用于药品的保藏或稳定性。圆筒护套可以在其表面配置有填料存取孔口21,以允许利用选择的药物填充隔室,另配置有剂量孔口22,以将剂量隔室排空到剂量室30。
护套还可以由薄膜例如带、薄片或膜材料形成,其可以粘附在剂量圆筒以隔离单独的剂量。薄膜应当足够坚固以保持药物材料,但是当单独的剂量将加载到吸入器的剂量室中时,其也可以设计成相对于单个剂量隔室穿孔或者移除。这种可选的设计的实施例如图2所示,其中凹座(不可见)以螺旋状形成在剂量圆筒上,护套包括一条可剥离的薄膜、薄片或带15。
图3A-C显示了本发明的另一个实施例。在这个实施例中,形成剂量圆筒的圆柱体直径增大而高度减小,形成剂量环60。剂量环采用带有轴向设置的隔室的圆形带的形式,其将接收预先计量的药品重量和/或容积。剂量环可以与促使环在一个旋转方向前进的驱动器连接。鉴于图1A-D的剂量圆筒的高度大于单行剂量隔室,剂量环仅仅是单行剂量隔室的高度。
本发明的护套适于在所示实施例中形成环护套70,一个围绕剂量环的紧密配合套,用于将各个剂量容纳在各自的剂量容器中,并提供防潮层用于药物保藏。类似于上述的护套,环护套将具有填料存取孔口71和剂量孔口72,后者与剂量室连接。类似于上述的剂量圆筒,环护套可以替换为可剥离的薄膜、薄片或带,其可以恰好在暴露到剂量室之前从各个剂量容器移除。
本发明的剂量圆筒可以通过与包括所期望药物的料斗配合来加载单独的剂量,其中单独的剂量隔室的几何尺寸可以用于帮助计量药物。
剂量圆筒可以作为吸入器的可重复使用部件制造,或者作为一次性药物剂量容器制造。特别的设计可以教导关于什么材料适合在剂量圆筒的生产中使用。
本发明的另一方面提供了一种将药物利用如上所述的剂量圆筒输送到人或者动物病患的气道的吸入器。再次参考图1A-D,吸入器包括剂量圆筒10、剂量室30和流道40,剂量圆筒10具有其上配置了多个剂量隔室12的圆柱形基底,剂量室30用于在输送给病患之前从单独的剂量隔室中接收单独的药物剂量,流道40临近剂量室以将药物输送到病患的气道。
剂量室30可以包括谐振腔,其具有的容积和形状将在选择的频率产生声学共振。谐振腔可以依次与振动设备50例如压电传感器连接,以提供振动能量,用于利用谐振腔的声学特性产生合成喷射流,如共同拥有的美国专利7,318,434、7,334,577和7,779,837中所述,所述专利的内容通过引用而结合到本文中。谐振腔将通过剂量孔口22从剂量圆筒接收单独的剂量。其他合适的振动设备的实施例公开在共同拥有的美国专利申请11/060,267中,其通过引用而结合到本文中。
之后药物材料解聚并由剂量孔32通过合成喷射排入流道40中。剂量孔促进合成喷射流的形成并有助于将药物从剂量室传送到流道中。孔的尺寸会影响合成喷射流速度,并最终影响微粒分配。
振动设备50与电源52连接。为了最佳性能,振动设备可以进一步与频率发生器连接,例如在共同拥有的共同未决美国申请12/392,686中所描述的,该申请通过引用而结合到本文。
吸入器可以利用放置设备来推进剂量圆筒并使特别的剂量隔室与具有护套的剂量孔口对齐。放置设备可以是例如螺旋传动设备。放置设备可以影响绕剂量圆筒的表面的剂量隔室的几何配置的选择,例如如图2所示。
本发明的吸入器还可以包括室密封。室密封可以以塞子的形式在设备空转时防止通道的空气进入剂量室中。包括这可以进一步地避免单独的剂量意料外地暴露于水分、氧或其他污染物。室腔密封将在吸入器的授权信号发出后开启,从而当吸入器感受到患者吸气时(例如参见美国专利6,152,130和美国公开的申请2005/0183725,这两者都指定共同的受让人),并且在剂量完成之后关闭。
室密封可以进一步地通过氮气线路连接到加压的氮气室,这将用剂量之间的氮气充满剂量室。它还可以连接到真空源以排空剂量之间的空气和水分。这可以通过利用同一氮气线路的至少一部分完成。室密封还可以连接到干燥室以吸收在配量过程中从空气传递来的湿气。
本发明公开的设备可容易地改进。例如,剂量室可以连接到多个剂量圆筒以输送组合的药物产品。
参考图4-11,本发明的另一个方面提供了利用药筒120形式的药物输送包装的吸入器101,该药筒是可重复使用的或一次性的。该设备的工作原理与上述设备的类似,并在上述共有专利中有进一步的描述。特别地,公开号为2010/0294278的美国专利,其通过参考并入本文,描述了紧凑的吸入器,其中多个单独的药物剂量容纳在旋转的盒子中。盒子包含径向配置的单独的气孔。在此描述的吸入器在许多方面与本发明的当前方面类似,除了旋转的盒子由包括气孔带130的药筒120替代。其他的差异通过下面的讨论变得明显。
如图4-10所示,吸入器通常包括壳体110和药筒120。如同上述公开的内容,吸入器包括接口125和振动设备111。接口连接流道123,其与气雾室121连接,位于振动设备附近。然而,与上述实施例不同的是,接口、流道和气雾室结合到药筒120中。这种设置优势在于,减小了吸入器的尺寸,保护了药品和保持了性能。
药筒120包括气孔带130,其包括基底133,例如低温形成的塑料,其中形成有一系列的凹陷134或孔穴以容纳单独的剂量105。薄片、薄膜或带子135放置在基底上以密封单独的凹陷,其形成填充有药物的单独的气孔131。药筒还包括气雾室121,其中单独的剂量根据上述的和以上参考的申请中的方法解聚。如在本文中所述,气雾室优选为谐振腔,并且通过在装配时与振动设备111接触的薄膜122限界。
在所示实施例中,药筒还包括推进设备140,用于相对于气雾室121推进气孔带130。用于推进气孔带的设备包括臂、弹簧、凸轮、齿轮、轮子或它们的任意的组合。例如,图5显示了引导环148,其接合气孔带,类似于弹簧和臂的组合,以推进气孔带。气孔检测开关142感知气孔带的推进,并有助于控制气孔带的推进,以不断地相对于气雾室121定位单独的气孔。
药筒还包括薄片、薄膜或带子去除设备141,用于在其相对于气雾室推进时,从气孔带移除薄片、薄膜或带子。薄片、薄膜或带子去除设备包括卷带轴145。当薄片、薄膜或带子移除时,单独的剂量105注入气雾室121以输送至病患。
在气孔带130上的气孔131的设置有助于或者要求药筒120形成环,即,在中心具有开放区域150。壳体包括互补的凸起151。在凸起中,壳体包括电池112和电机113。电机转动齿轮143,144,从而驱动卷带轴145和薄片去除设备141。电池还提供能量给振动设备111,振动设备111可以是压电设备。电池也可以携带于药筒上,并可替换药筒。可选择地,气孔带可通过例如手拧螺丝、杠杆或钟表机构推进。
在所示实施例中,壳体还包括进气口116,其与药筒的流道124连接。O型环119可以设置来促进在流道和进气口之间的接口的密封。通过电池供电的压力传感器117位于靠近进气口的压力传感器口118内,以感知病患通过吸入器的呼吸。
现有的方面可以根据本文中包括的和通过参考并入的共有专利包括的其他实施例进行修改。例如,吸入器可以构造有接口125,流道123,气雾室121,或者它们的组合,形成主壳体110的一部分以替代药筒120。
本发明还提供一种方法和装置,用于计量药物材料的剂量值,并且将该剂量输送到病患的气道。
例如,本发明的一个方面提供了用于将药物剂量输送到病患的气道的吸入器。预计的病患可以是人或者动物,因此吸入设备应当相应设计。吸入器将结合干粉吸入器来讨论,但是可预见的是本发明还可以应用于改进其他类型的吸入器的设计。
吸入器包括储存器,其容纳团块形式的药物材料。参考图11A-B和图12A-B,储存器的一个有利的形状可以是圆柱体,其中储存器包括活塞211和压缩弹簧212以帮助排空储存器。其他的形状,例如球形、圆锥体等,也是可利用的,附图并不意味着将本发明限制于使用圆柱体储存器。其他形式的背压也可以使用以代替活塞和压缩弹簧。类似地,除了所示螺旋弹簧外,多种类型的弹簧也适于应用在本发明的吸入设备中。本发明显著的优点是储存器可以再次装载团块材料,该设备也可以重复利用。
本实施例的吸入设备还包括计量装置,用于测量团块药物材料,形成单个药物剂量。计量装置应当具有用于接收来自储存器的药物材料的计量凹座,该计量凹座具有适合接收需要剂量的尺寸。
参考图11A和11B,计量装置可以包括计量圆筒220和护套230。在这个实施例中,计量凹座形成为计量圆筒外表面上的计量凹限222。该凹陷可以是与计量圆筒整体地形成,并且应当以精确的容积制造,以计量药物剂量。
护套230形成为围绕计量圆筒的外表面紧密配合,但不会紧到限制计量圆筒绕其轴线旋转。吸入设备可以包括用于旋转计量圆筒的驱动器。计量圆筒的旋转将使得计量凹座222对齐在护套中的两个孔231,232中至少一个。填料存取孔口231设置在护套30上与储存器10的接口,允许向计量凹座222填充药物材料201。剂量孔口232,允许计量的药物剂量被输送到剂量室240。
剂量室构造为接收单个药物剂量,解聚药物材料,并且将材料输送到流道250。剂量室将基于多种可用于将药物输送给病患的方法构造。
如同上述的实施例,剂量室包括谐振腔,其具有的容积和形状将在所选频率产生声学共振。这个特征的优点已经在上文中描述过了。
参考图12A和12B,本发明的计量装置可以包括计量凹座或由至少两个计量门225,226封闭的计量隔室。第一计量门225在计量隔室和剂量室240之间。第二计量门226在计量隔室和储存器210之间。这样,当第二计量门打开(第一计量门保持关闭),计量隔室可以加载药物材料201。然后,当第一计量门开启(第二计量门保持关闭),计量的药物材料剂量可以放置在剂量室中。
本发明还提供了一种用于将药物材料输送到可以是人或者动物的病患的气道的方法,通过提供与计量装置连接的储存器中的药物材料;利用计量装置计量药物材料以形成单个药物剂量;将单个药物剂量移动到剂量室中;解聚在单个药物剂量中的药物材料;通过流道将单个药物剂量从剂量室输送到病患的气道。
本发明的方法可以使用例如本发明中描述的包括计量圆筒和护套的计量装置。可替换地,计量装置可以包括封闭在第一计量门和第二计量门之间的计量隔室,其中第二计量门在计量药物材料的步骤中开启,第一计量门在将单个药物计量移动到剂量室的步骤中开启。
剂量室可以用作与振动设备连接的谐振腔,其中解聚药物材料的步骤包括激活振动设备以产生合成喷射流,从而将单个药物剂量从剂量室通过流道输送到病患的气道。
本发明的另一方面提供了一种设备,其用于将药物材料计量到选择的剂量值并且将该剂量输送到病患的气道。本发明的设备是吸入器,其包括容纳药物材料的室和用于将药物材料输送给病患的流道。这些元件的每一个的基本功能已在上述共有专利公开的内容中描述。
根据本发明,多个药物材料剂量储藏在组合的储存器和剂量室内,该剂量室设计成存储多个药物材料剂量,并且在预定剂量计量出药物材料。
参照图13,图示的吸入器包括组合的储存器和剂量室,其构造成接受药物材料的供给,解聚药物材料和输送材料到流道340。组合储存器和剂量室330包括谐振腔,其具有的容积和形状将在所选频率产生声学共振。谐振腔及其优点已经在上文中详细地描述。
本发明的吸入器可选地包括室密封336。室密封可以是塞子的形式以防止通道的空气在设备空转时进入到组合的储存器和剂量室中。这包括进一步避免药物材料不必要的暴露于水分、氧或其他污染物。室密封将在例如当吸入器感测到病患吸气时根据吸入器的授权信号开启(参见之前参考的共有专利和申请),并且在剂量已经输送之后关闭。
室密封336可选地进一步与加压氮气室通过氮气线路360连接,这将在剂量之间用氮气填充组合的储存器和剂量室。室密封336也可以连接真空源以排空剂量之间的空气和水分。这可以通过利用相同的氮气线路360的至少一部分完成。室密封还可以连接到干燥室以吸收在配量过程中从大气传递来的湿气。
本发明允许组合的储存器和剂量室保持多个剂量,以通过合成喷射流排出。剂量尺寸可以通过控制频率和各个活化的持续时间来电子控制。因为声谐振受保留的药品负荷的影响,每个剂量的活化优选是电子定制的,以提供对于每个剂量的持续的药品排出,例如通过感测电源和振动设备的运动,以及输送给振动设备的功率的反馈控制,根据共有的美国专利申请12/246,208的教导,
其通过引用并入本文。
本发明的实施例是经过测试的,利用建立的气孔作为谐振腔用于排出多个剂量。4毫克气孔载入到测试设备中,设定参数以允许从大约1毫克的药物在各个剂量排出。这样重复用于其他的剂量。气孔在致动之间移除和称量。在下列的表1和表2中,通过改变"工作时间"或振动设备的活化持续时间,可以看出,
即使在振动频率和模式没有最佳化的情况下,剂量仍然可以以足够的可预计性输送。
表1150毫秒工作时间
表格2.125毫秒工作时间
本发明公开的设备可容易地改进。两个或更多组合的储存器和剂量室可以并入单个吸入器以输送组合的药物产品。
本发明的又一个方面提供了一种将药物材料输送到人或者动物病患的气道的方法。该方法提供容纳在组合的储存器和剂量室内的药物材料,剂量室也充当谐振腔。然后药物材料在组合的储存器和剂量室内振动解聚,然后药物材料在组合的储存器和剂量室内振动分解,允许单个剂量通过合成喷射流输送给病患。由此解聚药物材料的步骤可以通过控制持续时间实现,从而产生合成喷射流,其中通过电源352提供功率给振动设备344,如上所述。电源也可以是频率控制源,用于进一步控制合成喷射流的效果。
组合的储存器和剂量室也用作与振动设备连接的谐振腔,其中解聚药物材料的步骤包括激活振动设备以产生合成喷射流,从而将单个药物剂量从组合的储存器和剂量室通过流道输送到病患的气道。
本发明提供独特的、节省空间的设计,其允许创造较小输送装置、储藏材料和药物包装,以在单个包装中包括更多数量的计量的剂量,并且提供一种机制以将干粉吸入剂输送给当前未使用商用干粉吸入器的病患。
在本文中使用的术语"药物"包括适合于通过吸入器输送的所有形式的药品。例如,虽然本发明特别地适用于干粉吸入器(DPI),该技术也可以用于改善其他实施方式的吸入器。因此,在本发明中涉及的药物必然包括液态形式的药物以及干粉药物。
此外,术语药物不应当严格地解释为排除其他可用的物质,例如植物药物,维生素类,激素,类固醇及其他生物活性小分子,缩胺酸,蛋白质等等。
需要强调的是,上述的本发明的实施例,尤其是"优选的"实施方式,仅是实施中可能的例子,并且仅是为了清楚理解本发明的原理而提出的。在不脱离本发明的精神和范围的情况下,可以设计和/或制造多个与本文中描述的用于吸入器的药物包装的不同的实施方式。所有这些和其他这样的修改和变化包括在本发明的范围之内,并且受下列权利要求的保护。因此本发明公开的范围仅由附带的权利要求限定。
Claims (6)
1.一种药物输送包装,该药物输送包装包括多个单独的药物剂量,并包括:
剂量圆筒,其由构造为伸长的圆柱体的基底材料形成,该剂量圆筒包括多个剂量隔室以直接容纳单独的药物剂量,其中多个剂量隔室的每一个均包括在圆柱体外表面上的凹陷的容积,该凹陷的容积朝向剂量圆筒的中心延伸;和
围绕剂量圆筒的并由可剥离的带、薄片或薄膜组成的护套,该护套在剂量隔室中容纳和隔离多个单独的药物剂量,
其中,护套形成为围绕剂量圆筒的外表面紧密配合,用于将各个剂量容纳在各自的剂量隔室中,并提供防潮层用于药物保藏;和
邻近剂量圆筒的剂量室,用于从剂量圆筒接受单独的药物剂量,其中所述剂量室是与振动设备连接的谐振腔。
2.根据权利要求1所述的药物输送包装,其中,药物为干粉形式。
3.根据权利要求1所述的药物输送包装,其中多个剂量隔室以多行的形式设置,围绕剂量圆筒的圆周延伸。
4.根据权利要求1所述的药物输送包装,其中多个剂量隔室以螺旋状模式设置。
5.根据权利要求1所述的药物输送包装,其中剂量圆筒形成为剂量环,多个剂量隔室以单行的形式围绕圆柱体的圆周设置。
6.根据权利要求1所述的药物输送包装,其中振动设备是压电设备。
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US20160220771A1 (en) | 2016-08-04 |
EP2521584A1 (en) | 2012-11-14 |
PH12014501462A1 (en) | 2014-10-20 |
PH12014501461A1 (en) | 2014-10-20 |
JP2016093525A (ja) | 2016-05-26 |
HK1221184A1 (zh) | 2017-05-26 |
WO2011085022A1 (en) | 2011-07-14 |
JP6017961B2 (ja) | 2016-11-02 |
CN104338219B (zh) | 2017-10-24 |
CA2784041C (en) | 2017-11-07 |
JP2013516283A (ja) | 2013-05-13 |
TW201143823A (en) | 2011-12-16 |
CN104338219A (zh) | 2015-02-11 |
EP2521584B1 (en) | 2018-10-17 |
US20140041659A1 (en) | 2014-02-13 |
US10434267B2 (en) | 2019-10-08 |
TWI589313B (zh) | 2017-07-01 |
CN102665807A (zh) | 2012-09-12 |
JP6087887B2 (ja) | 2017-03-01 |
CA2784041A1 (en) | 2011-07-14 |
JP6283344B2 (ja) | 2018-02-21 |
JP2015037588A (ja) | 2015-02-26 |
JP6469610B2 (ja) | 2019-02-13 |
MY187036A (en) | 2021-08-27 |
US8991390B2 (en) | 2015-03-31 |
ES2702753T3 (es) | 2019-03-05 |
EP2521584A4 (en) | 2015-04-01 |
JP2016165510A (ja) | 2016-09-15 |
US20110162642A1 (en) | 2011-07-07 |
EP3431128A1 (en) | 2019-01-23 |
PH12014501461B1 (en) | 2014-10-20 |
US9974909B2 (en) | 2018-05-22 |
PH12014501462B1 (en) | 2014-10-20 |
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