CN102438685A - 用于干粉吸入器的旋转盒系统 - Google Patents
用于干粉吸入器的旋转盒系统 Download PDFInfo
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Abstract
本发明提供一种吸入器,其具有用于雾化包含在泡罩包装内的药物的振动元件,其中在旋转盒内设置多个单独的泡罩包装,所述旋转盒装配于壳体内的,并且,其中牵引多个单独的泡罩包装至位于振动元件和穿孔元件之间的钳夹位置。泡罩包装的移动由壳体内的旋转盘控制,更进一步地,所述旋转盘还分别调整用于穿孔和分散多个单独的泡罩包装的穿孔元件和振动元件的移动。
Description
技术领域
本发明主要涉及吸入装置领域。本发明具有相关于递送药物粉末给患者的特别应用,并且将相关于所述应用进行描述,但是其他应用也是可预期的。
技术背景
已知呼吸道的某些疾病是响应于通过直接应用治疗剂的治疗。由于这些治疗剂最容易以干粉的形式被利用,所以通过鼻子或嘴吸入粉末材料的形式能最方便的完成其应用。该粉末形式使得药物能被更好地利用,因为药物被精确地置于所需的位置以及需要其效用的位置;因此,非常小剂量的药物也能同样起到通过其他方法施用更大剂量的药物的效力,从而相应地显著降低不希望的副作用的发生率和药物花费。可选择地,这种形式的药物可以用于治疗除了呼吸系统的疾病之外的其他疾病。当药物被置于肺部的非常大的表面积上时,其可以非常快速地被吸收至血流内;因此,这种治疗方法的应用可以代替注射、药片或者其他常规方法的给药。
这是制药工业的一个观点,即当递送至呼吸道的药物颗粒的大小在1至5微米之间时,药物的生物利用度最优。当药物颗粒需要在这个大小范围内时,干粉递送系统需要解决许多问题:
(1)小尺寸的颗粒可能在制造和储存的过程中会在其上产生静电电荷。这可能使得颗粒结块或者聚集,形成实际尺寸大于5微米的颗粒团簇。使这些大的团簇进入肺的深部的可能性降低。相应地,这导致低百分比的包装药物提供给患者来吸收。
(2)需要被递送至患者的有效药物的量可以是10s微克的倍数。例如,在沙丁胺醇(一种用于哮喘的药物)的情况下,这个通常是25-50微克。当前的制造装置可以有效地以可接受的精度递送在毫克剂量范围内的药物等份。因此,标准的操作是将有效药物与填充剂或者膨胀剂相混合,比如乳糖。该添加剂也使得药物“易于流动”。该填充剂也被称为载体,因为药物颗粒通过静电或者化学键也粘附于这些颗粒。这些载体颗粒比药物颗粒在尺寸上要大很多。在设计的效果方面,干粉吸入器将药物与载体分离的能力是一个重要的性能参数。
(3)尺寸大于5微米的有效药物颗粒将被置于口中或者喉咙中。这个就引入了另外程度的不确定性,因为药物在这些位置的生物利用度和吸收率与肺部的是不同的。干粉吸入器需要将放置在这些位置的药物减少到最小从而减少与药物的生物利用度相关的不确定性。
现有技术中的干粉吸入器(DPIs)通常具有用于将药物(有效药物加上载体)引至高速气流的装置。使用高速气流作为用于破碎微粉化的颗粒的团簇或者将药物颗粒从载体中分离出来的主要机制。已知在现有技术中有多个对分配这种粉末形式的药物有效果的吸入设备。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,公开了多个具有用于将含有粉末药物的胶囊穿孔的装置的吸入设备,在吸入时,粉末药物从穿孔的胶囊中抽出并且进入使用者的口中。这些专利中好几个公开了推进装置,在吸入时,其能帮助粉末分配出胶囊外,所以,单独地依赖吸入的空气以从胶囊中吸入粉末并不是必须的。例如,在美国专利2,517,482中,公开了一种装置,在吸入之前其具有设置在较低的腔室内的含有粉末的胶囊,在那里,其由使用者手动地压低穿孔针而被穿孔。穿孔后,吸入开始并且胶囊被拖拽至装置的较高的腔室内,在那里,其在所有方向上移动以导致粉末通过穿孔进行分散并且进入到吸入的气流内。美国专利号3,831,606公开了一种吸入设备,其具有多个穿孔针、推进装置以及独立的粉末源,通过外部手动操作用于操作推进装置,因此,当吸入时,推进装置帮助粉末分散进入吸入的气流。同样地也可以参考美国专利号3,948,264和5,458,135。
在先的美国专利号7,318,434和7,334,577通过引用纳入本文,并且专利权转让于共同的专利受让人MicroDose Technologies,Inc.,这里提供了一种对现有技术中的利用振动以促进悬浮的粉末进入吸入的气流中的吸入器的改进,并且该改进利用合成喷射以雾化来自泡罩包装或者类似物中的药物粉末。如前述美国专利号7,318,434和7,334,577中所启示的,提供一种干粉吸入器,其具有第一腔室比如泡罩包装或者其他包装物,用于容纳干粉,和第二腔室,其通过通道与第一腔室连接,用于接收来自第一腔室的雾化形式的干粉并用于将雾化的干粉递送给使用者。振动器连接至第一腔室内的干粉。振动器被通电并且连接至第一腔室并且通过合成喷射驱动来自腔室的粉末。
正如通过引用纳入本文,并且专利权转让于共同的专利受让人MicroDose Technologies,Inc.的美国专利7,080,644中所述,药物或药品的控制的等份或者剂量都预先包装在泡罩包装内,其包括可以是锥形、具有圆点的锥形、圆形或者其他凸起的形状结构的易碎的凸起顶部元件,以及底部元件,其可以是平板或薄膜,或者其自身可以是有形状结构的部分,比如,锥形、圆形、盘形等,用于严密地接合在下面的振动元件,所选择的形状和大小用于最好地控制给定的药物或药品的递送。泡罩包装的顶部元件由穿孔元件,比如尖针,穿孔以形成一个或多个用于递送容纳在泡罩内的药物或者药品的孔。选择孔的形状和孔的大小以提供包装在其内的特别药物或药品的递送的最优化。
发明内容
本发明提供一种现有技术中的装置的改进的技术方案,比如上述讨论的提供具有用于雾化容纳在泡罩包装内药物的振动元件的吸入器,其中,吸入器适合容纳多个单独的泡罩包装,所述泡罩包装可以是分别地被接近并且移动至在振动元件和穿孔元件之间的操作或分配位置。这种结构的优点包括;更简单,更加紧凑地装配用于包括多个泡罩包装的吸入器;并且能够隔离并且保护单独的泡罩包装在使用之前远离穿孔元件。
附图说明
在参照附图的之后详细的说明中可以看到本发明的更多特征和优点,其中,
图1A和1B是根据本发明的吸入器的俯视图,显示了在不同位置的杠杆臂;
图2A、2B和2C是根据本发明的具有由杠杆臂致动的旋转盒的吸入器的剖视图;
图3是根据本发明的匣壳(cartridge)组件的分解图;
图4是根据本发明的匣壳组件被置于吸入器的壳体内的示意图;
图5示出了根据本发明的吸入器的底部;
图6A示出了根据本发明的泡罩包装;
图6B是示出了根据本发明的泡罩包装运载器的操作的图解;
图7是根据本发明的干粉吸入器的内部元件的局部视图;
图8a和8b是根据本发明的泡罩包装运载器和穿孔装置的细节剖视图;
图9A和9B是根据本发明的流动通道以及振动和穿孔元件的细节剖视图;
图10是显示与本发明的干粉吸入器相关的电子操作的方框图;
图11是根据本发明的印刷电路运载器的示意图;
图12是根据本发明的干粉吸入器的截面侧视图;以及
图13是根据本发明的干粉吸入器的分解图。
具体实施方式
以下说明将参照附图,附图是说明书的一部分,并且在附图中通过图示的方式示出了本发明的多种实施例。可以理解的是其他实施例也是可以被使用的并且在不偏离本发明的范围的情况下可以做出多种改变。
本发明提供一种用于向使用者的气管递送药物的装置,其中该装置通常包括具有附着的管嘴的壳体和用于管嘴的盖。壳体适于容纳多个含有比如粉末药物的单独的泡罩包装。然而,药物也可以是液体形式的药物。这样设置泡罩从而使得单独的泡罩可以装载在夹钳位置内,然后泡罩被穿孔并且使用振动装置聚集泡罩的内容物,其随后将被使用者吸入。优选地,泡罩放置在匣壳内,在优选的形式中,匣壳包括其内包含多个单独的可设定位置的泡罩包装的旋转盒。该装置也包括用于在装载位置和操作位置之间移动选定的泡罩包装的机构。该机构也可以用于启动穿孔和振动元件。
参照图1A和1B,本发明所公开的吸入器包括具有管嘴2的壳体1和可收缩的盖3。该装置也可以包括杠杆臂11,其运动能开启可收缩盖并且启动装置的其他元件,这将在下文进行详细的描述说明。也可以手动地开启可收缩的盖,比如,当使用者需要清洗管嘴时,但是当杠杆臂11已经移动至开启位置时,不能被关闭。
参照图2A-2C,杠杆臂11连接至容纳在壳体内的凸轮盘10,凸轮盘10将杠杆臂的旋转运动转变为装置的其他内在元件的平移运动动或旋转运动。如图所示,装置设置成允许杠杆臂旋转120°,这是用一只手操作装置的通常的运动范围,但是其他的范围也是可以的。当杠杆臂从一个位置行进至另外一个位置时(参见图2A-2C),凸轮盘10被转动并且可收缩的盖3不覆盖管嘴2。凸轮盘的旋转如参照线110所示。
杠杆臂的远端(相对于凸轮盘)设置有按钮区域11A,其设置用于使使用者易于抓握并且移动杠杆臂。例如,按钮的表面积应当足够大以使得易于拉伸杠杆臂并且按钮的表面也可以由能增强使用者的抓握的材料组成。在杠杆臂的运动的任一端,装置可以包括程序列锁,其能使得杠杆臂和凸轮盘能保持在固定位置,直到使用者再次移动杠杆臂。
可选择地,也可以使用其他运动以启动装置。例如,装置的盖可以通过联动装置连接至凸轮盘,当盖开启时,联动装置转动凸轮盘。
参照图1A和1B和2A-2C,装置也包括将信息传达给使用者的指示器70,其可以包括,例如,当施用新的剂量时的提示信号,当使用者应当吸入时的指示信号,当使用者应当完成吸入时的指示信号以及例如当设备是空的,药物过期,或者装置经受环境极端时,比如加热或者冷却,超出其设计范围时的报警信号。当泡罩包装已经被打开并且将不再被储存时,装置应当将吸入信号显示给使用者。齿合特征也可以被整合到凸轮盘10中以防止装置的部分或者意外启动。
图3示出了本发明的匣壳组件的不同部件。包括旋转盒的匣壳20通常这样设置,以使得多个单独的泡罩包装21相对于旋转盒的平面以径向方式展开。图3示出了一个包括上部壳体23和下部壳体24的匣壳。匣壳包括泡罩传送带22,其使每个泡罩包装21都分隔开。匣壳也包括泡罩运载器27,其用于每次将一个泡罩沿着径向通道移动至操作位置。匣壳可以被设置用于运载很多的泡罩。
如图4所示,匣壳可以被移除和再装载或者被置换,以使装置可以继续被使用。图5示出了匣壳也可以包括剂量计算器25,用于追踪剂量的数量,以及释放键26,以便于匣壳的拆卸。
图6A示出了典型的泡罩包装,其他泡罩包装设计也是可以的。例如,可以与本发明的装置相配的其他泡罩包装设计参见,美国申请公开号2006/0174869A1、2008/0202514A1以及2009/0314288A1,全部转让给共同的受让人并且通过引用纳入本文。可选择地,泡罩包装可以包括分开的包装或者泡罩包装,其含有两种或多种药物或药品,例如,可以是相同或者不同的颗粒大小,一起递送给使用者,例如,如美国申请公开号2005/0147566A1中所述,其也转让给共同的受让人。
如上所述,通过使用泡罩运载器27推动新鲜的泡罩包装21至一位置,容纳在泡罩包装内的药物或者药品被递送至患者。如图6B中的箭头所示,泡罩运载器的运动是径向方向的。
泡罩运载器以及可收缩的盖的运动,都是通过杠杆臂11的移动来启动的,杠杆臂的旋转运动使用凸轮盘10传递至其他相应的元件,其包括一系列的槽、凸轮和/或尖针,控制连接至装置的其他元件的联动装置的移动。这些连接由图7示意性示出,其示出了与匣壳组件20、振动组件40、以及穿孔组件50相连接的各种联动装置的配置。(在这个视图中未示出凸轮盘)。凸轮盘连接至匣壳量度联动装置13,其转动匣壳使得每次装置被使用时下一个泡罩是可用的;泡罩运输联动装置18连接至泡罩运输撬28,泡罩运输撬依次连接至泡罩运载器27;以及振动器联动装置14;穿孔联动装置15。匣壳组件还包括多个棘轮齿12,能够量度部件。这里所示的联动装置仅作为示例。一些其他的结构也同样是可以的。例如,联动装置的长度和数量也可以改变,但是仍然能获得相似的结果。
在多个凸轮、槽以及从动针、旋转针或者其他彼此相抵触的部件存在的地方,凸轮盘10可以包括两个平的连接在一起的内部和外部盘,比如,在中心连接。以这种方式,盘可以包括多个重叠的槽或者凸轮。
参照图8A、8B、9A和9B,泡罩运载器27将选定的泡罩包装21移动至在穿孔组件50和振动组件40之间的位置。泡罩的顶部延伸穿过开口31进入连接至管嘴2的流动通道30。泡罩包装由振动组件40固定在合适的位置,振动组件40包括用于使压电式换能器41抵靠泡罩包装放置并且将泡罩包装保持在合适的位置的弹簧42。可以设置支柱45以保证在振动元件和泡罩包装之间保持适当的接触。可选择地,在流动通道30内的开口31可以开的足够大以使得泡罩包装进一步延伸至流动通道,其中泡罩包装21的边缘区域被固定在压电式换能器和流动通道之间。槽43与突出部44成一直线,限制弹簧42的弹簧的运动范围。
当用于刺穿泡罩包装时,穿孔组件与位于流动通道的相反侧的泡罩包装成一直线并且具有延伸穿过孔32的穿孔器51。穿孔器可以包括一个或多个针以充分地刺穿泡罩包装。
振动组件40可以包括压电式换能器41作为振动元件,但是其他振动元件也包括在本发明的保护范围内,比如,如提供声波振动的麦克风。振动元件导致在泡罩包装内的粉末药物在周围的空气中被雾化并且可以产生合成喷射,将药物分散到流动通道30内。然后药物被运输至抽吸穿过管嘴2的患者的吸入气流内。
振动元件可以由流量传感器60启动,正如美国专利号6,152,130以及正在申请的美国申请号11/064201所述,流量传感器60感应患者的呼吸,上述两个专利都为本申请人拥有并且通过引用纳入本文。参照附图10-12,流量元件60包括流量传感器61,其信号被调节201并且发送至微处理器203。在与系统时钟电路202相连接的微处理器内的控制逻辑内,通过驱动电路206控制振动元件,比如说压电式换能器41。由电池81提供振动元件的电量,电池81由线路205进行调节。当吸入完成后,微处理器也发送信号至使用者界面70的发光二级管(LEDs)71。如上所述,当自从上次剂量之后的预定时间已经过去时,微处理器也可以发送信号至使用者的界面70。
一旦泡罩包装变空,可以这样处理即将空的泡罩通过接近管嘴2的壳体的顶部提取出来。可选择地,其也可以被储存在匣壳内或者其他不碍事的地方直到用完所有的泡罩包装,这时,移除空的盒后,可以在吸入器内装载新的盒。
图13示出了本发明的元件的分解示意图。壳体1可由多个部件组成,包括装置盖4和底盘5。包括微处理器和多种电路的印刷电路板组件82,通过弯曲的电线62连接至流量传感器。在图13中所示的组件可以被改变但是却不脱离本发明的精神。例如,凸轮盘可以在尺寸上减小并且以不同于平盘的其他形式,但是却仍然提供同样的功能。
应当强调的是,上述的本发明的装置和方法的具体实施例,特别地,并且“优选的”实施例,仅仅是技术方案的可能的实施例并且仅仅是为了更清楚地理解本发明的原理。很多不同与用于这里提到的干粉吸入器的旋转盒系统的实施例可以被设计和/或被构造,但是却没有脱离本发明的精神和范围。例如,药物的有效递送可以通过操纵压电振动器的波形而最佳化。所有这些以及其他这样的调整和改变都是可预期地包含在本发明的范围内和之后的权利要求的保护范围内。因此,本发明的范围除了显示附属的权利要求中不能被限制。
Claims (22)
1.一种药物吸入器,包括
壳体;
固定于壳体的管嘴;
包含在壳体内的振动元件和穿孔元件;
装载在壳体内的多个单独的可设定位置的泡罩包装,其中多个单独的可设定位置的泡罩包装的每一个都含有特定数量的药物;以及
用于将选定的泡罩包装在装载位置和分配位置之间移动的装置。
2.如权利要求1所述的吸入器,其中,所述多个泡罩包装装载在盒上。
3.如权利要求2所述的吸入器,其中,所述盒可旋转地安装在壳体内。
4.如权利要求1-3中任一项所述的吸入器,其中,还包括可旋转地安装的盘,其调整所述多个单独的泡罩包装中的一个的移动,使其进入分配位置,在那里单独的泡罩包装在振动元件和穿孔元件之间被夹住。
5.如权利要求4所述的吸入器,其中,旋转盘还调整穿孔元件的移动,由此穿孔元件刺穿在分配位置的泡罩包装。
6.如权利要求4所述的吸入器,其中,旋转盘还调整振动元件的移动,因此,振动元件与泡罩包装在分配位置相接触。
7.如权利要求4所述的吸入器,其中,使用者通过使用突出于壳体的杠杆臂控制盘的旋转。
8.如权利要求1-7中任一项所述的吸入器,还包括用于盖住枢轴地连接于壳体上的管嘴的盖。
9.如权利要求8所述的吸入器,其中,还包括将盖与旋转盘连接的联动装置,其中盘的枢轴运动转换成盖的缩回。
10.如权利要求1-9中任一项所述的吸入器,其中,振动元件是压电式换能器。
11.如权利要求1-10中任一项所述的吸入器,还包括电池和印刷电路板。
12.如权利要求1-11中任一项所述的吸入器,其中,多个单独的泡罩包装设置在圆形平面内,并且其中泡罩包装的平面与匣壳的平面大体上垂直。
13.如权利要求4所述的吸入器,其中,盘还调整旋转地安装的盒的运动。
14.如权利要求1-12中任一项所述的吸入器,其中,药物包括干粉。
15.如权利要求1-12中任一项所述的吸入器,其中,药物包括液体。
16.一种干粉吸入器,包括
振动元件;
穿孔元件;
包含多个单独的可设定位置的泡罩包装的匣壳附件,其中多个单独的可设定位置的泡罩包装中的每个都含有特定数量的粉末药物,泡罩包装被设置成圆形结构;以及
杠杆臂,其运动能使得选定的泡罩包装被牵引到振动元件和穿孔元件之间的位置以进行分散并且被使用者吸入。
17.如权利要求16所述的干粉吸入器,还包括盘,其能调整杠杆臂的运动与所述多个单独的泡罩包装中的一个的运动,使其到达操作的位置。
18.如权利要求16所述的干粉吸入器,还包括其一端与管嘴连接的流动通道,流动通道具有开口,选定的泡罩包装的顶部与所述开口相匹配,泡罩包装通过振动元件被保持在抵靠流体通道的合适的位置,其中穿孔元件位于流动通道的另一侧。
19.如权利要求18所述的干粉吸入器,还包括支撑振动元件抵靠选定的泡罩包装的弹簧。
20.如权利要求1-19中任一项所述的干粉吸入器,其中,选定的泡罩包装由泡罩运载器牵引,其使选定的泡罩包装沿径向移动。
21.如权利要求1-20中任一项所述的干粉吸入器,还包括感应使用者的呼吸的流量感应器。
22.如权利要求21所述的干粉吸入器,还包括电池和微处理器,其中微处理器接受来自流量传感器的信号并且控制振动元件的启动。
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CA2762819C (en) | 2016-12-20 |
JP2014193390A (ja) | 2014-10-09 |
CN102438685B (zh) | 2014-07-02 |
JP5804583B2 (ja) | 2015-11-04 |
CA2762819A1 (en) | 2010-11-25 |
ES2682996T3 (es) | 2018-09-24 |
JP2012527329A (ja) | 2012-11-08 |
CL2011002900A1 (es) | 2012-09-07 |
AU2010249402B2 (en) | 2014-08-21 |
AU2010249402A1 (en) | 2011-12-15 |
MX2011012265A (es) | 2012-04-11 |
BRPI1011194A2 (pt) | 2016-12-27 |
WO2010135672A1 (en) | 2010-11-25 |
NZ596564A (en) | 2012-11-30 |
US20100294278A1 (en) | 2010-11-25 |
EA201171452A1 (ru) | 2012-05-30 |
KR20120036873A (ko) | 2012-04-18 |
JP5752679B2 (ja) | 2015-07-22 |
MY159925A (en) | 2017-02-15 |
EP2432536B1 (en) | 2018-07-04 |
EA026215B1 (ru) | 2017-03-31 |
KR101585707B1 (ko) | 2016-01-14 |
US8763606B2 (en) | 2014-07-01 |
EP2432536A4 (en) | 2015-12-23 |
EP2432536A1 (en) | 2012-03-28 |
PE20121146A1 (es) | 2012-08-27 |
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