CN101820939A - 吸入装置 - Google Patents
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Abstract
干粉吸入***包括震动机制。干粉供应器操作上耦接震动机制。功率源连通震动机制。传感器连通震动机制。反馈控制器连通传感器和功率源。反馈控制器可依传感器提供的震动机制性能相关信息来控制传送给震动机制的功率。
Description
技术领域
本发明大体上是关于吸入装置,且特别是关于利用震动来协助粉末(如粉状药物)悬浮于吸入气流(如吸入空气)的吸入装置。
背景技术
某些呼吸道疾病可直接投予治疗剂进行治疗。这些药剂最常以干粉状形式存在,最方便的使用方式则是经由鼻或口吸入这些粉状材料。粉末形式可提高药剂效用,因为药物可正确沉积在其期望的位置以及其需要产生作用处;故很微量的药物效果常和利用其它手段给予大剂量的药效一样,因此可大幅减少不当的副作用和药剂费用。或者,此形式的药物可用来治疗呼吸***以外的疾病。当药物用在相当大面积的肺脏时,其可快速吸收进入血流;故此给药方式可代替注射、服用药片或其它传统手段。
制药业认为,输送到呼吸道的药粒大小为1-5微米时有最佳的药物生物利用度。要将药粒制作成此尺寸,干粉输送***需解决一些问题:
(1)在制造及储存时,小粒子本身会产生静电电荷。此将导致粒子结块或聚集,使得粒子簇(cluster)的有效尺寸大于5微米。这些大粒子簇可能会进入肺脏深处而减少。因而造成可供病患吸收的包装药物百分比减低。
(2)需输送给病患的速效药用量可能为数十微克。以气喘用药albuterol为例,其通常使用25-50微克。目前制造设备在可接受的精确度内可有效输送毫克范围的药量。故标准作法为混合速效药与填料或增体剂,例如乳糖。添加剂亦能让药物「更易流动」。填料也称为载体,因药粒会透过静电或化学键黏在这些填料粒子上。载体粒子远比药粒大。干粉吸入器分离药物与载体的能力是设计的要素。
(3)大于5微米的速效药粒子会沉积在口中或喉咙。此将引起另一不确定性,即该位置的药物生物利用度和吸收效果不同于肺脏。干粉吸入器需减少药物沉积在这些位置,以降低药物生物利用度的不确定性。
先前技术之干粉吸入器(DPI)通常具有将药物(速效药和载体)引至高速气流的装置。高速气流做为散开微米级粒子簇或分离药粒与载体的主要机制。先前技术已知数种用来分配粉状药剂的吸入装置。例如,美国专利证书号3,507,277、3,518,992、3,635,219、3,795,244和3,807,400揭露的吸入装置具有刺穿含粉状药剂之胶囊的装置,且吸入剂是从刺穿之胶囊释出及进入使用者口中。其中数个专利揭露推进装置,此有助于吸入时将粉末分配出胶囊,因而不需只仰赖吸入空气来抽吸胶囊内的粉末。例如,美国专利证书号2,517,482提出之装置具有含粉末之胶囊放在下腔室,吸入前,由使用者压下刺针而刺穿。刺穿后,开始吸入,胶囊则被引到装置的上腔室,在此朝各方向四处移动,以分配粉末通过穿孔及进入吸入气流。美国专利证书号3,831,606披露之吸入装置具有多个刺针、推进装置和透过外在手动操作控制推进装置的自给功率源,故吸入时,推进装置有助于将粉末分配至吸入气流。
这些先前技术装置呈现的数个问题和缺点可由本发明之吸入装置解决。例如,先前技术装置需要使用者赋予相当大的吸入效果才能将刺穿胶囊的粉末分配或吸引至吸入气流。利用先前技术装置,藉由吸入使粉末穿过胶囊穿孔的方式通常无法吸引胶囊内全部或大部分的粉末,以致浪费药剂。又,先前技术装置会产生不受控制的粉状材料量或团块吸入使用者口中,而非固定、细致散布的粉末吸入控制量。
已知先前技术包括用来协助吸入粉状药剂的装置,其包括设有主要与次要空气入口信道和出口信道的主体部分。次要入口通道围住含粉状药剂之胶囊,出口通道形成伸出主体的口。胶囊刺穿结构乃设置于旋转时形成一或多个孔洞于胶囊中,故当电机震动器震动胶囊时,胶囊可释出粉状药物。Wilke等人提出之刺穿装置包括三个放射配置且装在摆线式腔室的弹簧偏压刺针。用手转动腔室后,刺针同时朝内径向移动而刺穿胶囊。进一步转动腔室,可利用弹簧底座让刺针缩回到原位而将刺针抽出胶囊。
电机震动器的最内端包括震动活塞杆,其伸进入口信道与出口信道的交叉点。机械螺线管蜂音器连接活塞杆,用以赋能杆子以震动。蜂音器由高能量电池提供动力且由外部按钮开关启动。一旦经由出口通道吸入并同时压下开关启动电机震动装置,空气被抽吸通过入口信道,通过次要入口信道的气流则抵着震动活塞杆抬起胶囊。胶囊因此快速震动而流体化粉末及从穿孔分配粉末。此技术常用于制造分配通过送料斗的粉末,其震动送料斗以流体化粉末及移送粉末通过送料斗出口。胶囊的穿孔代表送料斗出口。通过入口通道的气流有助于抽出胶囊内的粉末及经由出口通道将粉末送到使用者口中。电机震动装置可设置垂直入口腔室,震动幅度和频率可经改变来调整吸入器的分配特性。
故如上述,震动器的吸入器为电机装置,设有由螺线管蜂音器驱动的杆子。电机装置可为驱动凸轮的马达。使用此吸入器的缺点在于,杆子有效震动胶囊所需的机械动作很大。因胶囊壳的弹性和药物与胶囊的惯性所致,杆子的移动范围通常需为约数百微米。
再者,螺线管蜂音器的操作频率一般小于5仟赫(kHz)。此操作频率易产生噪音,从病患的观点看来并不适合用于干粉吸入器。电化学致动器的另一缺点为需使用高能源,因此需要大量的电池,或者常需更换携带型单元的电池组。从病患的安全性和「方便使用」的方面考虑皆不期望有上述特征。
与专利提及的其它吸入器相比,此吸入器主要用来减少留在胶囊的粉末。然上述装置无法将粉末分散成小于6微米的粒子或团簇,以符合有效输送药剂至肺脏的需求;反而像先前技术之吸入器一样,仍继续仰赖气流速度将喷入气流中的粉末分散成适合输送至肺脏的粒子大小。
在先前技术之另一吸入装置中,液态药剂经超音波装置雾化,例如压力组件。气流(通常呈高速)或推进物接着将雾状粒子输送给病患。喷雾器雾化液态药剂所需的能量很高,故此输送药物至肺脏的方式只适合桌上型单元。驱动偏压组件及形成必要的机械位移所需的高电压亦对装置重量和尺寸的影响甚大。喷雾器操作原理显然也不能应用到输送粉状药物给肺脏的干粉吸入器。
先前技术装置具有一些缺点,故不适合用来输送干粉至肺脏。部分缺点为:
先前技术之吸入器性能与使用者产生的流率有关。流率太低无法完全分散粉末,因此会影响输送至病患的剂量。
因缺乏一致的分散过程,故各剂间的药物生物利用度不一致。
驱动电机型吸入器需要高能量,如此会增加装置体积,故不利于携带使用。
又一先前技术装置包括一吸入器,其利用震动促使粉末悬浮于气体中,藉以克服上述和其它的先前技术缺点。更特别地,吸入器包括压电震动器,用以震动粉末。控制器设置来控制供应震动器震动粉末的致动电力(即振幅及/或频率),使得至少一部分的粉末悬浮于气体中。控制器包括使用者启动控制,供使用者选择最适合目前用于吸入器之粉末悬浮于气体中的震动频率及/或振幅。控制器可预先校正使用者启动控制,让控制器调整供给震动器的致动电力的频率及/或振幅,使之符合震动使用者启动控制选择之粉末类型所需的频率及/或振幅,使至少一部分的粉末悬浮于气体中。就待悬浮于气体中的平均粉粒大小及/或预定之震动频率和振幅而论,使用者启动控制可包括选择变化层次。震动频率一般宜调整成至少为约12kHz,以将常用的粉状药物悬浮于气体中。震动频率和振幅可经调整以有效地让待使用之特定粉状药物悬浮。
发明内容
本发明提出改良先前技术之吸入器,包括如上述之压电震动器(piezoelectric vibrators)。更特别地,申请人已发现过度位移恰与压电换能器(piezoelectric transducers)的过早失效有关。故操作干粉吸入装置期间获得换能器位移相关的反馈是有益的。压电陶瓷具有机械力与电压的双向关系,而可同时做为驱动与反馈装置。然就小巧、低成本的装置而言,辅助反馈***的体积太大又昂贵。本发明则可提供此反馈。
本发明之实施例提供干粉吸入器的***和方法。简言之,一***实施例的构造如下。***包括震动机制。干粉供应器在操作上耦接震动机制。功率源连通震动机制。传感器连通震动机制。反馈控制器连通传感器和功率源。反馈控制器依传感器提供的震动机制性能相关信息,控制传送给震动机制的功率。
本发明尚提出提供干粉吸入器反馈控制的方法。在此,一方法实施例可总结成以下步骤:利用第一功率输入,驱动震动机制达到趋近稳态;移除第一功率输入,其中至少一部分的震动机制继续震动;移除电压输入后,感应震动机制的震动;以多个不同功率输入来重复进行驱动、移除及感应之步骤;决定何种电压输入可产生最大感应震动;以及放置震动机制,藉以分散干粉。
熟谙此技艺者在检阅以下图式和详细说明后,将更清楚本发明之其它***、方法、特征和优点。说明书中提及的所有附加***、方法、特征和优点皆落在本发明之范围内,本发明之保护范围当视后附之申请专利范围所界定者为准。
附图简单说明
本发明之许多态样在参照所附图式后将变得更易了解。为清楚说明本发明之原理,图中的组件不一定按比例绘制。再者,各图中相同的组件符号代表相应的部件。
第1图为根据本发明第一实施例之吸入器的剖面侧视图;
第2图为根据本发明第一实施例,用于第1图吸入器之震动控制***的方块示意图;以及
第3图为根据本发明第一实施例,提供上述干粉吸入器的方法流程图。
实施方式
第1图为根据本发明第一实施例之吸入器2的剖面侧视图。如第1图所示,空气10或其它流体流入气流通道12。透过病患吸入装置2的呼吸动作可引发空气10流动。空气10从吸入器2的远程14经由通道12流向吸入器2的近端46。吹口设于吸入器2的近端46供病患吸入之用。
震动机制28设置在邻近吸入器2的第三开口16处。震动机制28可包括压电组件、超音波声学换能器、或任何其它电子/机械震动机制,但不以此为限。容器20设置邻近震动机制28。容器20和震动机制28至少够接近让震动机制28震动容器20。容器20可为泡壳胶囊,例如授予MicroDose Technologies公司之美国专利证书号7,318,434所述的泡壳胶囊,其一并附上供作参考。容器20容纳待震动机制28分散的粉末50。吸入器2的结构可设计成在每次用完吸入器2后,丢弃及更换容器20。
吸入器2内含控制电路48。控制电路可以一应用特定功能集成电路芯片及/或其它集成电路芯片实施。控制电路48可采用微处理器或单独的电气与电子组件形式,且可包括一或多个间接连通吸入器2的组件。控制电路48决定功率源26供给震动机制28的功率。控制电路可控制功率源26供给震动机制28的致动功率振幅及/或频率,此将影响震动机制28震动的程度。震动机制28与功率源26间的电性连接22提供致动功率,控制电路48则至少部分控制电性连接22。电性连接22包括电路装置,用以将功率源26供应的直流(DC)功率源转换成交流(AC)功率源给震动机制28使用,电路装置为电路设计领域的一般技艺人士所熟知。
震动机制28可包括压电组件28,其由具高频之材料组成,较佳为具超音波共振频率(如约15-100MHz),且按特定频率和振幅震动,此视施加的激电频率及/或振幅而定。用来制造压电组件的材料例子包括石英和多晶陶瓷材料(如钛酸钡和锆钛酸铅)。有利地,以超音波频率震动压电组件可减少以较低频率(即小于超音波)震动压电组件伴随的噪音。
第2图为根据本发明第一实施例,用于第1图吸入器之震动控制***的方块示意图。如同熟谙此技艺者所理解,第1图绘示之功能组件是针对本发明的可行实施例之一。在不脱离本发明之范围内当可修改、更动及/或重新配置第1图组件,且其它吸入器构造亦受益于在此所述之震动控制***。
控制电路48包括启动控制器70和控制子***72。启动控制器70包括开关机制,其依气流传感器40提供的信号来启动功率源26供电给控制子***72。气流传感器40会限制震动机制28在有人呼吸吸入器2的近端46时才启动。控制电路48上也可设置有肘节开关32,以确保功率源26因周遭气流而耗尽。换言之,当肘节开关32设定为「开」位置、及气流传感器40提供启动控制器70信号并指示气流信道12发生吸入时,控制器70允许功率源26供应控制子***72致动功率。然当肘节开关32设定为「关」位置、或气流传感器40提供给控制器70的信号指示气流信道12未发生吸入时,启动控制器70不许功率源26供应***72致动功率。
若启动控制器70先让功率源26供应控制子***72致动功率,则可使控制子***72进入初始化状态,引发提供预定致动功率频率和振幅的可控制电路74产生控制信号。控制信号使泵电路80依据储存于初始化内存82的储存值,传送最初期望的致动功率频率和振幅。可控制电路74包括频率扫描产生器76和频率产生器78。可控制电路74产生的信号可用来指示泵电路80,让泵电路80供应控制信号明定的致动功率给震动机制28。
较佳地,供给震动机制28的最初致动电力频率和振幅乃预先校正来驱使震动机制28达稳态条件。如同熟谙此技艺者所理解,以趋近稳态驱动压电组件90震动时,实质上可从震动机制28传送最大的震动功率至容器20内的粉末50。此结果已发现可有效分散及悬浮容器20内的粉末50于使用者吸入的空气中。然若容器20或粉末50放置在震动机制28上,则容器20的重量与体积和待分散之粉末50的重量、体积与特殊尺寸会改变震动机制28的震动特性,导致震动机制28以共振频率以外的频率震动。该所造成的频率将引发震动机制28传送至粉末50的震动能量减低,因而降低震动机制28将粉末50分散及悬浮于使用者吸入空气的效率。
在控制电路48中,一旦达到稳态,即停止泵电路80的供应信号。震动机制28因其动量而继续震动。若震动机制28包括压电组件,则在停止泵电路80之供应信号后的最早几个循环,因压电作用,持续震动将感生电压,此可由传感器88(如伏特计)测量。测得电压恰与压电组件90的位移呈正比关系。
频率扫描产生器76和频率产生器78有***地产生控制信号来指示泵电路80供给至震动机制28之许多不同的电力振幅和频率。当震动机制28「循环完」不同频率和振幅时,立即停止泵电路80供应的信号,同时传感器88侦测震动机制28在各频率和振幅下的持续震动特性,且传送此信息至尖峰功率侦测器86。尖峰功率侦测器86分析传感器88的输出,并于功率传送特性呈侦测局部最大值时,发信号通知取样保持反馈控制器84。取样保持反馈控制器84使局部最大值关联于可控制电路74控制供给震动机制28的频率和振幅。取样保持反馈控制器84可将信息储存在连通取样保持反馈控制器84的内存500。
频率扫描产生器76和频率产生器78扫描完供给震动机制28的功率频率和振幅后,取样保持反馈控制器84促使可控制电路74循环完产生局部最大值的功率频率和振幅,及决定何种频率和振幅可产生整个震动机制28的侦测最佳功率传送特性。
操作时,以前述方法刺穿容器20及啮合震动机制28的表面。肘节开关32设定为「开」位置时,使用者由近端46吸入空气。气流传感器40感应到空气10的吸入,因此发信号通知启动控制器70,进而供电给控制子***72。控制子***72接着调整供给震动机制28的致动功率振幅和频率,直到能适当地将容器20内的粉末50分散及悬浮于气流中。
第3图为根据本发明第一实施例,提供上述干粉吸入器2的方法流程图200。应注意如同熟谙此技艺者所理解,流程图中的任一方法叙述或方块代表模块、片段、部分编码、或步骤,其包括一或多个指令来施行方法的特定逻辑功能,且交替实施亦落在本发明之范围内,其中功能可不按所示顺序执行,包括实质同时或反序,此视涉及的功能性而定。
如方块202所示,利用第一功率输入,驱动震动机制28达到趋近稳态。移除第一功率输入,其中至少一部分的震动机制28继续震动(方块204)。移除电压输入后,感应震动机制28的震动(方块206)。以多个不同功率输入来重复进行驱动、移除及感应之步骤(方块208)。决定可产生最大感应震动的电压输入(方块210)。放置震动机制28,藉以分散干燥粉末50(方块212)。
欲强调的是,上述的本发明之实施例(特别是任何「较佳」实施例)仅为可能之实施范例,仅为便于清楚理解本发明之原理。任在不脱离本发明之精神和范围内,当对上述之本发明实施例可作各种之更动与润饰,本发明之保护范围当视后附之权利要求书范围所界定者为准。
Claims (10)
1.一种干粉吸入器,其包含:
一震动机制;
一干粉之一供应器,系在操作上耦接至该震动机制;
一功率源,连通该震动机制;
一传感器,连通该震动机制;以及
一反馈控制器,连通该传感器和该功率源,藉此,该反馈控制器控制传送至该震动机制的功率。
2.如权利要求1所述之干粉吸入器,其中该震动机制更包含一压电换能器。
3.如权利要求1所述之干粉吸入器,其中该传感器更包含一伏特计。
4.如权利要求1所述之干粉吸入器,更包含一内存,连通该反馈控制器,藉此,该内存可储存从该传感器传送至该反馈控制器的至少一讯息,该讯息系与从该反馈控制器传送至该功率源的至少一讯息相关。
5.如权利要求1所述之干粉吸入器,其中该反馈控制器更包含一频率扫描产生器,连接在该功率源与该震动机制之间,用以控制传送到该震动机制的一功率特性。
6.如权利要求1所述之干粉吸入器,更包含一尖峰功率侦测器,其连通该传感器。
7.如权利要求1所述之干粉吸入器,其特征在于以下一或多个特征:
(a)其中该震动机制更包含一压电换能器,且该传感器可侦测该压电换能器的电压输出;以及
(b)其中该反馈控制器使传送到该震动机制的复数个功率形式关联于该传感器的复数个输出,其中该反馈控制器可视情况任选地识别一传送到该震动机制之该些功率形式的功率特性,且该功率特性与该传感器之该些输出的一最大输出有关联。
8.一种提供干粉吸入器反馈控制的方法,该方法包含以下步骤:
利用一第一功率输入,驱动一震动机制达到一趋近稳态;
移除该第一功率输入,其中至少一部分的该震动机制继续震动;
移除一电压输入后,感应该震动机制的震动;
以复数个不同的功率输入,重复进行驱动、移除及感应之多个步骤;
决定何种电压输入可产生一最大感应震动;以及
放置该震动机制,藉以分散一干粉。
9.如权利要求8所述之方法,其中该放置步骤系在该移除步骤之前进行。
10.如权利要求8所述之方法,其特征在于以下一或多个特征:
(a)其中该驱动该震动机制之步骤更包含驱使一压电换能器震动;
(b)其中该感应该震动之步骤更包含侦测该压电换能器的一输出电压;
(c)其中该些不同的功率输入依一频率变化;
(d)其中该些不同的功率输入依一强度变化;以及
(e)更包含将该些不同的功率输入关联于复数个不同的感应震动之步骤。
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