CN105517607A - 吹入设备和方法 - Google Patents

吹入设备和方法 Download PDF

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CN105517607A
CN105517607A CN201480048716.7A CN201480048716A CN105517607A CN 105517607 A CN105517607 A CN 105517607A CN 201480048716 A CN201480048716 A CN 201480048716A CN 105517607 A CN105517607 A CN 105517607A
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animal
sensor
breath
equipment
signal
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班诺特·阿达莫
布伦丹·F·劳伦茨
查得·C·斯穆尼
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Mannkind Corp
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    • A61M2016/0018—Accessories therefor, e.g. sensors, vibrators, negative pressure inhalation detectors electrical
    • A61M2016/0024—Accessories therefor, e.g. sensors, vibrators, negative pressure inhalation detectors electrical with an on-off output signal, e.g. from a switch
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Abstract

公开了一种吹入设备和使用该吹入设备的方法。该设备配备有用于以一致的自动化的方式给予可再现管内气雾剂的交互式系统。该吹入系统是有用的，特别用于与包括小鼠和大鼠在内的实验动物一起使用，并且在兽医实践中还用于经由肺部途径对小动物进行治疗。

Description

吹入设备和方法
相关申请的交叉引用
本申请要求于2013年8月5日提交的美国临时专利申请No.61/862,484的优先权，该临时专利申请的全部内容通过引用方式结合于此。
技术领域
本发明涉及包括吹入(insufflation)设备的药物递送系统以及用于在吸入周期期间将一致的粉末递送到动物的肺部的方法。具体地，该设备配置有自动计算机化系统，该系统能够通过吹入将药物递送到例如实验动物以用于局部和/或全身给药研究。该设备实现了一致的和可再现的药物递送。
本说明书中引用的所有参考文献以及它们的参考文献的全部内容通过引用方式结合于此，这些参考文献适于教导附加的或替代的细节、特征和/或技术背景。
背景技术
肺部途径给药用于将药品递送至肺部内以治疗局部疾病或者实现全身性吸收。对于局部治疗而言，药物可以直接递送到化合物能够发挥作用的需要的部位。递送至肺部的最新药物被设计为对肺组织有效果。用于肺部递送的药物的示例包括血管扩张剂、表面活性剂、化疗剂或者用于流感或其它呼吸道疾病的流感疫苗，以用于治疗包括哮喘、COPD、囊性纤维化和肺部感染的疾病。肺部给药使得能够快速治疗这些慢性疾病和急性疾病。用于治疗诸如哮喘的肺部疾病的药物制剂可以通过若干方法提供，这些方法包括使用喷雾器(诸如使用治疗)，使用计量吸入器(诸如)和干粉吸入器(诸如ADVAIRPULMICORT)。包括诸如基因治疗中的核苷酸药物的生物制品在内的其它类型的治疗也已经提供给肺部，以例如用于囊性纤维化的基因治疗，其中，表达有效腺苷脱氨酶的逆转录病毒载体给予至肺部。
目前，用于利用生物制品治疗全身性疾病的制剂主要通过可注射组合物得到。已经使用了用于胰岛素的肺吸入和全身递送的干粉组合物(包括和)。
在期望全身性吸收的情况下，肺部的大的表面积、其薄的壁结构并且其局部靠近全身循环是有利的。由于活性剂在肠道中易于酶失活或者酶降解，所以将药物递送至肺部比口服活性剂(诸如蛋白质和肽)更具优势。此外，通过肺部吸收而进入全身循环更有效地绕过肝脏、到达靶组织，其中，肝脏是通过注射和其它给药途径递送的大多数药物的代谢作用部位。用于通过肺部递送许多其它组合物(从肽和蛋白质到小分子)以用于全身性给药的能力往往需要根据所使用的递送系统进行大量的研究和方法。
对于肺部递送而言，药品通常配制成液体或干粉形式，使得它们可以被雾化并被患者吸入。通过递送装置(诸如吸入器、喷雾器和雾化器等，其将有效载荷量的液体或干粉制剂转换成可吸入分散体)来实现雾化。该分散体由用于穿过呼吸道并沉积在肺部中的适当的小颗粒组成。太大的颗粒带来过大的惯性、冲击喉咙的后部并且被吞咽。太小的颗粒能够被呼出并且不会在肺中沉积。
对药物制剂的早期开发工作往往需要非临床试验。这可能涉及到小动物(包括小鼠、大鼠和其它啮齿动物)，其中，在发展成对大动物和人类给药研究之前，可以对药物递送、暴露和所取得的效果进行研究。可以使用动物模型来评估药动学和伴随有不良反应的药效学效果，以帮助发展或制止候选药物制剂的开发。因此，当评估潜在药物时，所试验的制剂的递送的一致性是极为重要的，以更精确地确保在人类中所预想的递送。例如，如果意图使用吸入器连同干粉制剂在单次吸入中递送药物，那么小动物试验将近似于在人类中预想的方法。
用于评估用于肺部递送的药物的递送和疗效的当前模型方法包括液体滴注或干粉吹入。这些方法已被研究人员开发，以使得候选药物制剂能够直接放置到肺部内。所述方法涉及诸如PennCenturyDP-4等的注射器状系统，其中使用细长钝头插管、干粉腔室和注射器将腔室中的内容物散布至动物的肺部中。为了进行吹入，将动物轻度麻醉并且对动物进行插管，以使得装置插管经过声带插入恰好在隆突之前的气管中，其中，气管分支通向支气管。通常情况下，喉镜用于在插入步骤期间帮助研究人员引导插管。然后压下注射筒以迫使内容物(液体、悬浮液或粉末)排出腔室、排到插管下方并且进入到动物的肺部内。根据动物的种类将粉末从吹入器排出的空气量通常在1.0ml至5.0ml之间。使用这种装备，粉末腔室内的阀特征防止空气流动和相继雾化直至达到最小阈值压力。因此，研究人员在启动期间施加显著的手动力压迫注射器筒，从而使用最小的空气体积来雾化腔室中的内容物。
上述技术遇到两个主要的挑战。第一个挑战是在呼吸循环期间定时递送药物。在呼出期间将粉末排放到动物中导致次优递送，这是由于内容物能被吹回并且不递送给试验受试者。随着粉末递送，粉末吹回情况导致呼出药物，这使得不能评估药物递送的数量并且混淆由药物产生的任何可测量的效果。在呼吸速率高和/或肺活量小的动物中(例如，在每分钟通常呼吸90次的小鼠中)，难以通过人工排出粉末或液体来避免吹回。第二个挑战是重复性和/或一致性。当前技术需要最小压力来分散药物制剂。装置允许影响分散的质量和一致性的最小压力以上的压力范围。使用最小所需压力产生的气流可能会产生具有大粒径的、不能被深度吸入到肺部中的气雾排放。由于惯性力变得太大，大尺寸防止深度前进至肺部中，从而迫使载药颗粒进入到肺部的上气道分支中。相反，使用较大施加压力产生的气流可以产生具有更高质量的气雾排放。这些喷出的气雾剂内的粒径可能会减小，并且因此将更加可能更深地沉积在肺部中。也难以克服一致性对所施加的注射器柱塞压力的依赖性。滴注和/或吹入研究通常涉及多个动物，如果手动执行这些步骤，这可能导致不同动物之间的药物递送发生变化。药物递送中变化的来源使得更难以解释药物效果的评估。
在实验期间，配药的可再现性要求递送给对象的药物制剂具有一致性和可再现性的结果。因此，本发明人认为有必要设计和制造设备、系统和方法来克服目前使用的标准设备和步骤中所遇到的问题。
发明内容
本发明提供了一种包括设备的药物输送系统，并且公开了用于将包括雾化颗粒的药物组合物递送至肺部的方法。
该设备包括以下构造的装置：该装置构造成用于测量和记录动物的呼吸循环，确定呼吸循环的区间，并且在与动物呼吸相关的预定区间(具体地，在吸入期间)递送气雾剂(aerosol)。该设备可以包括选自多种传感器的一个或多个传感器，包括但不限于加速度计、麦克风、应变仪和换能器。
在一个实施例中，特定于传感器的计算机算法继而可以对动物呼吸模式进行表征和定量，并且判定何时触发吹入以便与自然吸入动作同步地进行递送。在一个实施例中，剂量组合物的递送还可以与呼吸循环的吸入之前或者吸入期间的不同部分相同步。还可以检查吸入的持续时间，并可以评估吸入的持续时间以确定相对于吸入开始和结束的递送范围。在一个实施例中，主动监测动物呼吸还生成关于吸气/呼气的持续时间、呼吸的规律性和呼吸循环的其它特征的数据。在该实施例和其它实施例中，该设备设置有自动驱动机构，其通过调整机电装置来置换通过吹入装置的空气。在一个实施例中，线性螺线管可用于置换驱动泵的活塞，这种做法能够确保可重复的驱动力并且导致可重复的排放流速。
在一个实施例中，提供了一种设备，该设备包括：
第一装置，其包括用于将动物定位并构造成保持动物就位的区域，并且包括与至少一个传感器相适应的可调拉带和安装机构，其中至少一个传感器检测因呼吸所产生的动物胸部和/或腹部的扩张运动，所述传感器生成信号并将信号传递到微处理器以进行分析，并且安装机构包括用于固定到所述平台的支架；
第二装置，其包括螺线管、注射泵和粉末贮存器；其中，所述螺线管由板载中继输出系统致动以对注射泵进行加压；所述第二装置还包括具有可编程算法的计算机接口，该可编程算法检测动物呼吸模式并且致动所述螺线管以便在吸入期间的预定区间对注射泵进行加压，从而从粉末贮存器中释放粉烟(powderplume)。
在一个实施例中，第一装置还可以包括第二传感器，该第二传感器能够检测从动物呼吸循环中产生的声音。在该实施例和其它的实施例中，该设备还可以包括一个或多个模块，该一个或多个模块包括中继板和数据采集板的，其中，中继板(诸如自动关闭开关)用于中继输出信号。在该实施例中，第一组输入信号被第一传感器传送到构造有数据采集板的第一微处理器，其中该数据采集板捕捉来自传感器的输入信号、处理并分析第一装置中的第一组信号，并且使其连续流向计算机并与中继板通信，以致动螺线管并对注射器加压，从而自预定区间排出容纳在粉末贮存器中的粉末。
在一个实施例中，第一装置包括可调悬臂，换能器被安装在可调悬臂上并且被定位在动物上的期望位置处，以最好地测量与呼吸相关的生理变化，诸如隔膜扩张。
在具体的实施例中，提供了一种药物递送系统，该药物递送系统包括：气泵，其与螺线管相适应；吹入或滴注装置，其适用于气泵并且包括插管和用于容纳药物组合物的腔室；一个或多个传感器，其能够检测来自动物呼吸循环的信号；以及数据采集板，其包括用于分析和传输来自一个或多个传感器的信号的可执行算法，其中，可执行算法包括用于在呼吸循环的预定区间致动螺线管的指令。在示例性实施例中，采集板可以在计算机内处理来自传感器的信号(这使得系统模块化)或者可以为内置有螺线管的微处理器的一部分。在一个实施例中，动物被麻醉并且系统可具有包括加速度计和麦克风的至少两个传感器。
在又一个实施例中，公开了一种用于吹入动物(例如包括狗、猫、猴和啮齿动物(诸如小鼠或大鼠))的方法。在具体的实施例中，该方法包括以下步骤：将动物麻醉；在吸入设备中，将一个或多个传感器定位在动物上或者动物附近；检测并分析动物呼吸循环并且在所述动物的吸入区间给予试验组合物的剂量。在替代的实施例中，该方法也可用于向动物滴注溶液、悬浮液和/或蒸汽。
在具体的实施例中，检测和分析动物的呼吸循环包括将一个或多个传感器(诸如加速度计、麦克风或换能器)定位在动物上或者动物附近，该一个(或多个)传感器能够检测来自动物的信号并且将信号传输给数据采集板，通过该数据采集板、利用能够由例如板载微处理器、计算机或可编程逻辑控制器(PLC)执行的算法分析并评估信号。
在一个实施例中，来自一个或多个传感器(包括但不限于麦克风、热敏电阻、应变仪、加速度计等)的信号用于更好地使一个(或多个)传感器相对于动物定位。在该实施例中，经由计算机接口中继位置信息，在该计算机接口中，算法检测传感器输出。算法利用传感器特定标准(例如，信噪比、峰值检测、斜率检测、基线噪声等的有效性)判定位置是否可接受。传感器可以由操作员手动定位或者利用受控计算机(包括马达和气动机)和传感器反馈自动定位。
在一个实施例中，方法包括以下步骤：将待试验的动物定位到可进入区域，例如将动物捆绑到包括可调带的平台上，其中，可调带包括加速度计、换能器和/或麦克风的一个或多个传感器；定位一个或多个传感器，以检测由动物呼吸循环所产生的一个或多个信号；致动动力源并且设定加速度计，以检测预定数量的输入信号来表征动物的呼吸模式；以及在吸入期间将雾化粉烟递送给动物。在具体的实施例中，该方法包括以下步骤：确定动物呼吸频率和吸入区间；以及在吸入区间递送雾化组合物的剂量。在一些实施例中，动物可以任选地被捆绑到具有限制区域的平台上。在一些实施例中，可调带可以包括弹性材料。
附图说明
图1绘示了药物递送系统或设备的实施例的示意图。
图2A绘示了图1的设备实施例的示意图，示出了与包含加速度计的拉带相适应的、用于对动物定位的平台实施例的细节。图2B绘示了示出适应于进行离体试验研究的设备的气囊小鼠模拟器。
图3绘示了示出螺线管和注射泵系统的图1的设备的实施例装置部件的示意图。
图4绘示了本文的实施例的示意图，绘示了图示出与图1的设备相关的功能系统的流程图。
图5绘示了适应于图1中所示的设备的、包含药物腔室或贮存器的并且示出用于插进动物内并递送粉末剂量的插管的吹入装置的实施例。
图6A是图1中所示的实施例的平台部的、示出了平台部的组成部分的照片，并且图6B中示出附装的气囊模拟适配器来代表小动物。
图7是示出来自实施例设备的、使用气囊获得的输出信号的计算机屏幕截图，该气囊连接到泵以通过模仿诸如小啮齿动物的呼吸循环期间的充气和放气来模拟呼吸，并且该气囊组装到装置中。
图8是图1的设备实施例的替代平台的示意图，绘示了包含线性定位传感器的、用于与小实验动物一起使用的可动悬臂。
图9是图8中的平台实施例的修改顶视图的示意图，示出在高台上可移动的悬臂的定位。
图10是药物递送设备的操作系统的功能部件的示意图。
图11是本文所述的设备的实施例的硬件通信系统的示意图。
图12是利用与实验动物一起使用的示例性实施例设备的吹入顺序的示意图。
图13是示出由吸入研究获得的数据所产生的输出信号的计算机屏幕截图，该吸入研究在斯普拉格-杜勒鼠(SpragueDawleyrat)的吹入期间使用如图8和图9中所例示的实施例设备。
具体实施方式
在本文所公开的实施例中，公开了用于通过吹入将药物递送给动物的设备、系统和方法。
在图1-7所示的示例性实施例中，公开了具有交互系统的吹入装置以及用于向包括小鼠和大鼠的小动物给予管内气雾剂(aerosol)的方法。设备10能够用于递送干粉、悬浮液或液体形式的气雾剂。在一个实施例中，设备10可用于将干粉气雾剂吹入例如小鼠或斯普拉格-杜勒鼠中，以用于在研究和开发中递送试验药物制剂，并且在兽医学中用于小动物(包括狗、猫、豚鼠、仓鼠、猴子等)的诊治。
在该实施例中并且如图1所示，吹入设备10包括支架、用于对包括小鼠或大鼠的动物进行定位的平台14(图2A和图2B)、可动调节保持器9、数据采集系统(未示出)、包括诸如加速度计和/或麦克风的传感器15的拉带13、适用于小体积气泵16(图3)的螺线管17、以及单位剂量的可重复使用的吹入设备(图5)，其用于使来自与套管28相适应的粉末贮存器的预定剂量的粉末分散。在该实施例中，设备包括诸如麦克风和加速度计19的传感器18，以监测呼吸信号(包括声音信号、气流、胸部或隔膜扩张信号等)。在一些实施例中，设备可包括单个传感器或多个传感器，这些传感器可用于检测来自动物的不同类型的信号并且包括但不限于换能器(transducer)、应变计、压力表或热敏电阻。
图4是本文的实施例的示意图，并且示出了设备10的不同部件之间的物理性和/或电子性的相互作用的示例，其中，设备10包括两个传感器，第一传感器可以为用于检测腹部扩张的加速度计19，并且第二传感器例如可以为用于检测由动物呼吸循环所产生的呼吸声的微型麦克风19。在该实施例中，由第一传感器18和第二传感器19所生成的两种类型的信号被中继到数据采集板22，其中，该数据采集板接收不同类型的信号并且使它们流向包括动物呼吸循环的实时呼吸监测分析和处理能力的软件接口。设备10用软件算法来控制，以使来自传感器的特征电信号与动物的呼吸相关联。图4还示出来自数据采集板22的输出信号被发送到自动泵控制器26，以对适用于注射泵16的螺线管17进行致动，从而当在试验或治疗过程期间需要吹入操作给予剂量时使螺线管自动致动。
在该实施例和其它实施例中，还能够基于硬件和软件算法特征的选择来控制螺线管17对气泵16的致动，以施加恒定力水平或可变力水平。在一个实施例中，自动气泵16的触发由可执行算法来控制，并且然后可以在呼吸循环的任何点处被致动。这将允许泵的触发从呼吸循环内的特征偏离，或者以预测吸入、呼出或呼吸循环中的其它标记的方式。在该实施例中，最佳致动预计是在动物的吸入期刚开始时。在一个实施例中，气雾剂递送根据剂量和动物将以单脉冲或多个短脉冲的方式并且在单次或多次连续或非连续吸入期间进行。
在图1至图5中所公开的示例性实施例中，图1示出动物支架12、14和螺线管17驱动的手动泵16。图2提供图1所描绘的动物支架的特写，其包括平台14、动物保持可调杆设备9以及包括传感器19的动物拉带13。在该特定的实施例中，动物支架14包括麦克风滑板20、麦克风支架21、麦克风18、吊线和颈部支撑柱9、可调拉带13底座以及安装到可调拉带的加速度计19。在该实施例中，打算用大鼠的门牙将大鼠挂在线9上，并且颈部支柱为动物颈部的后部提供支撑和校准。拉带13和加速度计19被设计成定位在胸腹区域上的隔膜上方，以检测动物的呼吸循环。麦克风18定位于动物鼻子附近，以能够监测其呼吸循环。通过数据采集板22上的模拟端口收集来自麦克风18和加速度计19的数据，并且运行将加速度计和麦克风两者的信号转换成描述动物呼吸模式的信息的可执行算法。
图2B是图2A的实施例，该实施例包括用于对吹入设备进行离体研究的适配器，并且包括位于适配器的中心并连接到气泵的气囊，其中，气泵以预定的时间间隔对气囊进行充气以模拟小动物的呼吸模式。在一个实施例中，由计算机程序自动控制气泵。
图3是实施例的示图，其为图1中的自动泵实施例提供特写或者更详细的视图。自动气泵组件16包括可调节弹簧复位手动泵、螺线管安装筒17和螺线管24。在一个实施例中，手动泵16的排气量可以调整为小于动物的常规呼吸量或潮气呼吸量，以在吹入过程期间减小对动物的肺过度加压。对于小动物而言，气泵可以基于经历吹入的动物排出小于5ml、小于3ml、小于2ml或者小于1ml的量。在一个实施例中，由注射泵16所递送的加压空气的量为从约0.25ml至约1.5ml，或者从约1ml至1.5ml。在一些实施例中，能够根据动物和给予的剂量大小递送大于3ml的较大量的空气。在一个实施例中，注射泵由螺线管组件驱动，由于力以一致的方式被施加，所以注射泵生成可重复的结果和一致的力分布。自动气泵组件在使用时减少了典型吹入器中所需的空气量，以递送来自吹入装置的剂量的内容物，从而限制剂量内容物在吹入后被吹回。
图4具体绘示了示出自动化所需的顺序的方框图。在该实施例中，能够通过按压软件界面上的运行按钮来激活设备10。设备10的致动触发使得开始收集来自加速度计19和麦克风18两者的信号。在数据采集板22之前处理来自加速度计19的模拟信号。来自每个传感器18、19的模拟信号传输给数据采集板22，然后数据采集板22将信号传输给计算机或PLC中的软件以进行额外处理和实时分析。通过使用该软件的指令集，来自每个传感器18和19的信号被转换成用相关参数(例如，吸入的持续时间、呼出的持续时间、每分钟的呼吸次数、呼吸频率的变化、潮气量等)描述动物呼吸模式的信号。计算机软件29指令使得能够快速识别动物吸入动作的开始，并且从而允许在单次吸入结束之前致动泵并排出药物液体、悬浮液或粉末。在一些实施例中，如果药物量超出一次吸入中所能给予的量，可以通过预定数量的连续吸入或者以能够跳过一次或多次吸入的预定时间间隔来给药。
如前所述，吹入系统可用于通过气管内吹入来给予液体、悬浮液和干粉。图5绘示了单次剂量的可重复使用的吹入装置30的实施例，该装置能够适应于设备10，该设备10与气泵16相连，以用于与小动物(诸如啮齿动物)吹入系统一起使用。在该实施例中，吹入装置30可以被设计成给予不同类型的组合物(包括干粉)并且包括注射器30形式的大致圆柱形的主体。在一个实施例中，吹入装置30可以由短管17a连接到自动气泵16。该装置可以由包括金属的材料制成，以减轻对被吹入的药物组合物的静态效应。吹入装置30还包括用于容纳粉末组合物的具有一个或多个阀的腔室15。在替代实施例中，腔室15可以包括用于液体或悬浮液的贮存器以在吹入时使用。吹入装置30的末端包括用于直接对麻醉动物进行插管的钝头插管28。一旦动物被插管，插管的钝端用于通过动物的嘴放置，直到它到达呼吸道的气管区域的隆突附近，以确保被吹入的药物组合物的肺沉积。图5还示出吹入装置30还包括空气入口32和一个或多个阀(未示出)装置，其中，空气入口允许空气在注射泵16的活塞返回时进入泵中，并且一个或多个阀用于在递送前调节腔室15中的进气和粉末容量。此外，腔室15可以连同或不连同插管28从短管17a上移除，以更换各个剂量单元(dosingunit)。
在替代实施例中，吹入设备包括用于与无需被捆绑或约束的动物一起使用的平台40。在图8和图9中所示的该实施例中，平台40被安装在支架42上，该支架包括底座44、适用于转轴48的支撑柱46、46’和轴45，其中转轴48构造成保持平台40，轴保持并支撑气泵、螺线管和吹入装置。在该实施例中，平台40由构造在底座44上的支架43支撑，并且平台被设计为包括具有悬臂52的可调高台组件50，其中悬臂能够根据经受吹入的动物的大小移动到不同的位置。在一个实施例中，臂状结构52通过接头连接到平台40以枢转、旋转和/或延伸，并且能被放置在动物的腹部上。图9是与图8和图9中所示的平台相适应的图1中所示的设备的一部分的变形顶部视图。如图8和图9中所示，传感器54包括换能器(特别是包括销56的线性传感器销54)、接线柱58、58’、用于例如通过大鼠的门牙保持大鼠的线60以及用于将高台调节或移动到位并调节动物上的传感器的螺杆62。在该实施例中，螺杆62使悬臂在垂直面上上下移动。在一些实施例中，平台40可以与包括多个传感器(其包括传感器54、麦克风、热敏电阻、换能器或加速度计)的机器人臂相适应。
在一些实施例中，平台40还可以包括能够可拆卸地连接到平台的顶端的鼻锥体57。鼻锥体57可以作为允许管道经过的托架，以保持动物麻醉。
在替代实施例中，悬臂上的传感器可以包括加速度计或其它类型的感测装置。传感器54可以被放置在臂的远端以用于监测来自动物的呼吸信号。图8绘示了吹入设备的旋转臂状部件的实施例。在替代实施例中，平台40包括具有加速度计的机器人臂。
图10是药物递送设备的一个操作系统的功能部件的示意图。如图10所示，一旦程序启动，由传感器检测74由动物产生的输入信号70以定位传感器72。该信号从传感器传输到数据采集板并由计算机进行处理。如果判定传感器具有适当的位置76，则信号被处理并且为作为基线呼吸数据的输出78。如果传感器没有适当地放置在动物上，则调整传感器79，直到获得可接受的基线信号。当正确地检测到基线呼吸信号，则可以开始施药80。由板载系统检测传感器输出81并确定该信号是否指示吸入开始82。如果信号不是来自于吸入，则系统继续监测直到检测到吸入，此时，系统能够触发螺线管的致动以激活气泵84。在一个实施例中，吹入系统可设置为用于单剂量递送86。如果多次给药或要给予重复的剂量，那么系统查询是否是最后触发86。如果不是最后触发86，系统将继续检测吸入信号直到所有剂量被递送，并且输出数据显示在屏幕上、被打印或保存在微处理器或计算机系统中88。
图11是所要求保护的设备的实施例的硬件通信系统的示意图。可以是麦克风、加速计、热敏电阻或换能器的传感器90将信号发送到可以是微处理器或计算机模块的一部分的数据采集板91。通过使用处理算法92处理并分析来自数据采集板91的信号，该处理算法检测传感器的定位和/或配药，并且还将关于动物呼吸模式和有关传感器的适当定位的输出传送给计算机95。处理算法92还对来自动物的吸入信息94进行分析，并且如果检测到吸入，则将信息送往数据采集板96以用于进一步动作。数据采集板判定是否需要触发吹入，并且若需要，则指示中继板97致动螺线管98并激活气泵，以在动物开始吸入时开始吹入。
图12是总结利用与实验小动物(例如，大鼠或小鼠)一起使用的示例实施例设备进行吹入研究所需的步骤顺序的示意图。
前面的公开内容是说明性实施例。本领域的技术人员应当理解本文所公开的技术阐明能良好地实施本发明的代表性技术。然而，本领域的技术人员考虑到本文的公开内容应当理解，在不脱离本发明的精神和范围的情况下，可以在所公开的具体实施例中进行许多改变，并且这些改变仍然能够获得相同或类似的效果。
示例1
监测并递送测定剂量的粉末组合物：
图6A和图6B中的照片绘示了旨在与小动物一起使用的组装实际设备，在该示例中，该设备设计为与啮齿动物(例如，大鼠或小鼠)一起使用。图6A绘示了由有机玻璃和金属支架以及平台组成的吹入系统原型。如图6A和图6B中所示，支架的一部分是可见的，由附装到安装机构的有机玻璃平台组成，其中该安装机构包括用于保持平台的支撑物。为了试验的目的，使用安装在加速度计带的下方以模仿大鼠或小鼠的腹部/胸部在呼吸期间的位移运动的气囊来说明本文的吹入设备。气囊固定到平台并且用于经历模拟吹入过程。气囊定位在与将处于吹入过程中的动物的腹部相同的位置处。该构造是作为允许评估由安装在拉带中心的加速度计捕捉到的信号的测试。气囊被连接到加压空气源和三通阀，并且因此能够被周期性地充气和放气以模仿小动物的呼吸模式。
图7中的从使用气囊的实验中获取的屏幕截图示出控制接口以及从加速度计中收集到的并显示在屏幕上的数据的曲线图。当气囊处于静止时信号的特征为基线。当气囊快速充气和放气时，加速度计测量快速变化的振荡信号。系统继而设置为致动第二装置中的螺线管，气泵(未示出)对注射泵进行加压从而在模拟吸入期间的预定区间从粉末贮存器中排出粉末。
示例2
使用大鼠进行吹入实验
在这些实验中，使用斯普拉格-杜勒鼠。使用图5和图8中所示的吹入组件、使用图12中所述的方法以及每千克重量的大鼠5mg的干粉组合物来对大鼠进行麻醉、插管和监测。在系统所检测到的自然吸入期间，由系统触发对每只大鼠的给药。从这些实验收集的数据显示，插管和吹入过程对于以一致的方式在吸入期间递送中子激活的二氧化铈(NM-212，比活度＝5.7μCi的141Ce/mgCeO2)的剂量是可实现的。表1图示出从这项研究中所获得的数据。
表1：吹入期间的吸入特性。
表1中的数据示出被本文的设备检测出的呼吸周期大于0.5秒。具体地，数据示出所检测的呼吸周期表明大鼠以0.68秒至1.52秒之间的时间区间进行呼吸，其中，吸入持续约62毫秒至约300毫秒。
图13是示出由吹入研究获得的数据所产生的输出信号的计算机屏幕截图，其中该吹入研究在斯普拉格-杜勒鼠的吹入期间使用本文所述的实施例设备。如图13中所示，以利用如图8和图9所述的线性位置传感器所收集的数据的实时曲线从波谷到波谷地示出了大鼠的每个呼吸循环。
前面的公开内容是示例性实施例。本领域技术人员应当理解，本申请中所公开的技术阐述了能良好地实施本发明的代表性技术。但是，本领域技术人员考虑到这里公开的内容应当理解，在不脱离本发明的精神和范围的情况下，可以在所公开的这些具体实施例中进行许多改变，这些改变仍然能够获得相同或类似的效果。
除非另有指明，说明书和权利要求书中所有表示成分数量的数字、特性(例如分子量)、反应条件等应当认为在任何情形下都由词语“大约”来修饰。因此，除非另有相反的表述，说明书和所附权利要求中阐述的数值参数是近似的，可以根据本发明所要获得的期望特性而改变。至少(但不应认为试图将等同原则的应用限制于权利要求的范围)，每个数值参数应当至少基于所记载的有效数字并且应用普通的四舍五入方法来解释。虽然阐述本发明广阔范围的数值范围和参数是近似值，但是具体示例中阐述的数值是尽可能精确地记载的。但是，任何数值都不可避免地包含有由于其相应的试验测量结果中的标准偏差而必然造成的某些误差。
描述本发明的上下文(尤其是所附权利要求的上下文)中所用的“一个”、“一”、“该”以及类似的标志词应当认为既覆盖了单数形式又覆盖了复数形式，除非本申请中有相反的表述或与上下文明确抵触。本申请中对于取值范围的引用只是作为对于落在该范围内的每个单独的值进行分别记载的速记方式。除非本申请中另有指明，每个单独的值都被包含在说明书中，就像被单独记载在本申请中一样。本申请中描述的所有方法都能够以任何合适的顺序来执行，除非本申请中另有指明或者以其他方式与上下文明确抵触。本申请中对于任何示例或示例性语言(如“例如”)的使用仅仅是为了更好地解释本发明，并非对于以其他方式要求保护的发明的范围施加限制。说明书中的语言不应认为表示任何未在权利要求中使用的要素对于实施本发明而言是必需的。
对本申请中所公开的发明的可替换要素或实施例进行的分组不应认为是限制。每组的成员可以被单独地引用和主张权利，或者与本申请中的其他组成员或其他要素相结合地引用和主张权利。已经预期到为了方便和/或专利性方面的原因，一组中的一个或多个成员可以被包括在组中或从该组删除。在发生了任何这种包含或删除情况时，说明书应当认为包含了这样修改过的组，从而满足了对于所附权利要求所用的全部马库什组的字面记载要求。
本申请中描述了本发明的某些实施例，包括对于发明人而言已知的执行本发明的最佳模式。当然，本领域技术人员在阅读前文的说明时会想到对于所描述的实施例的各种变更形式。发明人可以预料本领域技术人员在合适的情况下采用这些变更形式，发明人也预料到本发明会以与说明书中所具体描述的方式不同的方式来实施。因此，本发明包括了由可适用的法律所允许的、在此所附权利要求中记载的主题的全部修改和等同形式。此外，上述要素在其所有可能的变更形式中的任意组合都由本发明所涵盖，除非本申请中另有指明或以其他方式明显与上下文抵触。
此外，在说明书全文中还有对于专利和印刷公开文献的多处引用。上述引用内容中的每一者以及印刷公开文献分别通过引用方式全文结合在本申请中。
本申请中公开的具体实施例可以在权利要求中用“由……组成”或“主要由……组成”这样的语言来进一步限定。在用于权利要求中时，无论在提交时还是在进行修改时加入，连接词“由……组成”排除了该权利要求中未指出的任何要素、步骤或成分。连接词“主要由……组成”将权利要求的范围限制在所指出的材料或步骤，以及不会对基本的和新颖的(一个或多个)特性造成实质影响的材料或步骤。本申请中隐含或者明确地描述了所要求保护的本发明实施例，并使它们能够被实施。
最后，应当认为本申请中所公开的发明的这些实施例是对于本发明原理的举例说明。可以采用的其他修改形式也在本发明的范围内。因此，通过举例而非限制方式，根据本申请中的教导可以有本发明的替换性构造。因此，本发明不限于所具体示出和描述的内容。

Claims (18)

1.一种药物递送系统，其包括：
气泵，其与螺线管相适应；
药物递送装置，其适应于所述气泵并且包括插管和用于容纳药物组合物的腔室；
至少一个传感器，其用于检测被麻醉动物的呼吸循环；
数据采集板，其包括用于分析和传输来自一个或多个传感器的信号并判定和显示动物呼吸模式的可执行算法，其中，所述可执行算法包括用于在所述被麻醉动物的呼吸循环的预定区间致动所述螺线管的指令。
2.如权利要求1所述的系统，包括配置成检测动物呼吸的第二传感器。
3.如上述任一项权利要求所述的系统，其中，所述至少一个传感器为加速度计、麦克风、热敏电阻和/或换能器。
4.如上述任一项权利要求所述的系统，其中，所述至少一个传感器为麦克风。
5.一种设备，其包括：
第一装置，其包括平台，所述平台包括动物定位区，所述动物定位区包括可调拉带，所述可调拉带具有至少一个传感器，所述至少一个传感器检测因呼吸而产生的动物腹部和/或胸部的扩张，生成输入信号并将所述输入信号传送到微处理器以进行分析；
第二装置，其包括螺线管、注射泵和粉末贮存器；其中，所述螺线管由板载中继输出系统致动以对所述注射泵进行加压；并且其中，所述第二装置还包括计算机接口，所述计算机接口还包括可编程算法，所述可编程算法检测、分析和发送动物呼吸模式的指令，并致动所述螺线管从而在吸入期间的预定区间对所述注射泵进行加压。
6.如权利要求5所述的设备，还包括用于固定所述平台的安装机构。
7.如权利要求6所述的设备，其中，所述第一装置还包括第二传感器，所述第二传感器配置成检测动物呼吸。
8.如上述任一项权利要求所述的设备，其中，所述至少一个传感器为加速度计、麦克风、热敏电阻和/或换能器。
9.如上述任一项权利要求所述的设备，其中，所述至少一个传感器为麦克风。
10.一种吹入方法，其包括以下步骤：
将动物定位在吹入设备中，所述吹入设备包括与螺线管相适应的自动气泵注射器；
将一个或多个传感器放置在所述动物上或者所述动物附近以检测所述动物的呼吸信号，其中，所述传感器配置成检测和传输所述呼吸信号并且与数据采集板通信；
利用微处理器通过可执行算法实时分析来自动物呼吸循环的所述呼吸信号以判定和分析动物的呼吸速率和动物呼吸循环，以及
通过在所述动物呼吸循环的吸入的预定区间致动所述螺线管以产生预定力，在吸入区间给予测试组合物剂量。
11.如权利要求10所述的方法，其中，所述吹入设备还包括具有插管和容纳药物组合物的腔室的吹入装置。
12.如权利要求10所述的方法，其中，所述一个或多个传感器为加速度计、麦克风、热敏电阻或换能器。
13.如权利要求10所述的方法，其中，所述一个或多个传感器为麦克风。
14.如上述任一项权利要求所述的方法，其中，所述动物被麻醉。
15.如上述任一项权利要求所述的方法，其中，致动所述螺线管的步骤是根据来自包括可编程算法的计算机接口的信号来进行的。
16.如上述任一项权利要求所述的方法，其中，致动所述螺线管的步骤使得在所述气泵注射器中生成气压，其中所述气泵注射器排出所述试验组合物剂量。
17.如上述任一项权利要求所述的方法，还包括利用来自所述吹入装置的所述插管对所述动物进行插管。
18.如权利要求10-17所述的方法，其中，将所述一个或多个传感器放置在所述动物上或所述动物附近的步骤是自动的。
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