CN103751892B - 用于对吸入工作进行实时描绘的交互式设备和方法 - Google Patents

用于对吸入工作进行实时描绘的交互式设备和方法 Download PDF

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CN103751892B
CN103751892B CN201310625447.3A CN201310625447A CN103751892B CN 103751892 B CN103751892 B CN 103751892B CN 201310625447 A CN201310625447 A CN 201310625447A CN 103751892 B CN103751892 B CN 103751892B
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diskuses
signal
sensor
inhaler
sensing system
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丹尼斯·欧文菲尔德
卡尔·R·萨伊
班诺特·阿达莫
P·斯般瑟儿·堪赛
斯考特·麦克林
约翰·M·波利多洛
查得·C·斯穆尼
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Mannkind Corp
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Abstract

本发明涉及用于对吸入工作进行实时描绘的交互式设备和方法，公开了用于对对象使用干粉吸入系统的实时特性模式进行感知和测量的交互式设备和方法。这些装置可以以有线或无线通信模式使用来与显示器通信，以评估对象对吸入系统的使用、评价吸入系统的性能和/或检测从使用中的吸入系统发射的干粉配方的特性曲线。

Description

用于对吸入工作进行实时描绘的交互式设备和方法
本申请是申请号为200980123369.9、申请日为2009年06月19日，发明名称为“用于对吸入工作进行实时描绘的交互式设备和方法”的发明专利申请的分案申请。
相关申请的交叉引用
本申请要求2008年6月20日提交的美国临时专利申请No.61/074,487和2009年3月10日提交的美国临时专利申请No.61/159,052的优先权，这些申请的全部公开内容通过引用方式结合于此。
技术领域
本申请中描述了用于实时地对关键实体测量结果进行记录、转移和显示的交互式设备和方法，这些测量结果是在吸入(inhalation)过程中由对象基于生理条件而产生的。
背景技术
现在可以买到吸入器(inhaler)装置，这些装置用于通过呼吸道而分配治疗物质，尤其是在对局部的或全身的疾病进行的治疗中用于肺部递送。例如，喷雾器、包含压缩气体(propellant)的装置、以及干粉吸入器已经被用来治疗疾病，例如哮喘、呼吸道感染以及全身疾病(例如糖尿病)。
在疾病治疗中向病人递送所需剂量的治疗物质的效率取决于该装置的效率，可以通过在使用该器件的过程中给病人提供合适的反馈机构来改善总体上的递送，该机构例如将合适的吸入技术教导给病人。对这些装置的不当使用以及不佳的吸入技术可能造成疾病治疗缺乏效率，例如，通过给予比所需剂量更低剂量的治疗物质或更高剂量的治疗物质可能给病人造成伤害。为了有效地向呼吸道递送治疗物质，可能需要对病人或用户进行以恰当方式使用该装置的训练或指导。
用来向肺部递送药剂的干粉吸入器包含粉末配方的药剂系统，该配方通常是块状供给物形式或被定量成储存在单位剂量隔间中的单独药剂，这些隔间就像硬胶囊、药筒(cartridge)或起泡包装一样。剂量再现性要求药物配方是均匀的，并且可以以结果一致且可再现的方式向病人递送该药剂。因此，可以通过对配方的排放进行优化来改善定量给药(dosing)，所述排放例如是通过使病人执行合适的吸入过程来实现的。
例如在美国专利No.5,333,106中描述了用于训练病人通过呼吸道合适地递送治疗物质的装置，该专利公开了一种基于使用合适的吸入步骤时空气流与体积数据之间的关系在气溶胶吸入器的使用中对病人进行交互式训练的设备，该设备包括反馈显示器。美国专利申请No.10/759,859(公开号为US2004/0187869)公开了一种用于药剂吸入器(例如干粉吸入器)的训练装置，该装置基于对压力差异进行测量并显示既对应于吸入速度又对应于吸入流速峰值的一个值，该装置包括干粉吸入器模拟器。
在通过对吸入器和胶囊或药筒内的粉末配方进行解聚集(deagglomerate)而进行吸气过程期间，干粉吸入器和药筒系统可以产生主要药物颗粒或合适的吸入烟流(plume)，这些干粉吸入器和药筒系统例如美国专利No.7,305,986和No.7,464,706中描述的那些，对于这些专利所教导的与干粉吸入器有关的全部内容，通过引用方式全文结合于此。经过肺部循环递送药物具有多种优点，包括迅速进入动脉循环、避免了由肝脏代谢造成药物首次通过时的降解、容易使用(例如，与诸如注射之类的其他给药途径相比，不适感较少)。这些装置已被用在临床环境中，病人已被合适地训练使用这样的吸入器。
本领域需要对装置(该装置用于将对象训练为合适地使用吸入系统)的设计和制造进行改进、在吸入系统的使用过程中对病人进行监视、以及对吸入系统的性能(例如泄漏或缺陷的存在情况)进行监视。本发明提出了一些设备和方法来实现这些目的。
发明内容
本申请中描述了用于在吸入系统的使用期间对关键的吸气特征参数进行测量的设备。该设备和使用该设备的方法可以有利于例如对需要使用吸入器(例如高阻干粉吸入器系统)向肺部和肺循环递送药物、活性成分或药剂的对象进行训练和/或监视。本申请中公开的吸入系统的示例性实施例包括用于视觉提示的显示装置，以便于训练和/或监视对象对于通过吸气系统进行有效的治疗递送获得最佳的或合适的吸气过程。该系统便于训练这些对象合适地使用吸入装置，以对于该个人获得优选的流动分布，从而可以获得对于药剂的最大递送。这些装置和方法还可以用来对吸入系统的性能(例如，对于递送的剂量、所递送的药品的量、递送的药剂的排放时间、给予对象的药剂数目进行检测)进行监视，并对吸入系统的机械完整性进行监视。
在一种示例性实施例中，可以使该装置以交互方式工作，例如，该装置可以包括无线通信接口，以允许从远程获取数据，所述数据可以被发送到基于计算机/微处理器的系统，该系统提供了数据的交互式显示、数据的储存和/或基于网络的信息传输。或者，其他示例性实施例可以包括有线通信接口。
在一种示例性实施例中，该设备或装置可以例如适配到高阻干粉吸入系统，例如美国专利No.7,305,986和No.7,464,706、美国专利申请No.12/413,405和No.12/484,125中公开的那些系统，所有这些文献公开的与干粉吸入器有关的全部内容而通过引用方式全文结合于此。该装置可以包括:带有或不带容纳了药物配方的药筒的干粉吸入器;一个或多个换能器，包括电的、电子的、机电的、电磁的、光子的或光伏的换能器，例如压力传感器、温度传感器、声音传感器和光学传感器;信号调节电路和/或软件系统、用于电子信号通信的装置和输出显示器。在这样的示例性实施例中，该设备可以与模拟式或数字式传感器、合适的信号调节器(例如放大、信号滤波、模拟-数字转换)、用于板上处理的微处理器、与用于随后的信号处理和/或实时输出显示的远程计算机或个人数据助理(PDA)通信的无线通信器一起使用。该装置可以用来递送预先测定的单位剂量药筒中容纳的药物组分，所述药筒容纳了用于递送到肺循环的活性成分。在可替换的示例性实施例中，感知和监视装置可以被适配到吸入系统上或吸入系统内，该系统包括带有药筒的干粉吸入器，药筒可以是空的，也可以容纳有适于肺部递送的干粉。
干粉包括适于肺部递送的微粒，是本领域熟知的，例如包括美国专利No.6,428,771和No.6,071,497中公开的那些，这些专利的公开内容公开的与微粒有关的全部内容通过引用方式全部结合于此。在各种示例性实施例中，干粉、活性成分可以是蛋白质、肽、多肽或它们的组合，例如内分泌激素，例如胰岛素、胰高血糖素样肽-1(GLP-1)、甲状旁腺激素或其类似物(analog)。
在某些实施例中，用于递送到肺部循环的干粉配方包括活性成分或活性剂，包括肽、蛋白质、激素、其类似物或其组合，其中，活性成分是胰岛素、降钙素、生长激素、促红细胞生成素、粒细胞集落刺激生物因子(GM-CSF)、绒毛膜促性腺激素释放因子、黄体激素释放激素、促卵泡激素(FSH)、血管活性肠肽、甲状旁腺激素(包括黑熊PTH)、甲状旁腺激素相关的蛋白质、胰高血糖素样肽-1(GLP-1)、exendin、调酸素(oxyntomodulin)、多肽YY、白细胞介素2-诱导的酪氨酸酶(interleukin2-inducible tyrosine kinase)、Bruton酪氨酸激酶(BTK)、肌醇需求激酶1(IRE1)或类似物、活性片段、PC-DAC改性衍生物或其O端糖基化形式。在特定的实施例中，干粉配方的药物组分包括富马酰二酮哌嗪(fumaryldiketopiperazine)，活性成分是从下列项中选择的一项或多项:胰岛素、甲状旁腺激素1-34、GLP-1、调酸素、多肽YY、肝素、PTHrP以及它们的类似物。
在本申请中描述的一种示例性实施例中，干粉吸入器包括与干粉吸入器通信的传感器，其中，该传感器能够对至少一个信号类型进行检测并能够将信号发送到至少一个装置以进行分析、储存、打印或显示，该信号类型包括从干粉吸入系统产生的压力、温度和声音信号。在这样的示例性实施例中，传感器被构造在干粉吸入器内，或者适配到干粉吸入器，该传感器可以是话筒。
在一种示例性实施例中，吸入系统包括具有高流阻的干粉吸入器，阻值在大约每分钟0.065(√kPa)/升到大约每分钟0.200(√kPa)/升之间。高阻吸入系统可以设有感知和监视设备。在一种实施例中，传感器可以对吸入系统使用中产生的固有特征信号进行检测。在另一种示例性实施例中，传感器是声音传感器，其包括声音检测装置(或话筒)，该装置被构造成通过有线通信模式或无线通信模式将声音信号传送到系统中的至少一个其他装置。用于本申请中所述干粉吸入器的感知和监视装置还可以与模拟-数字转换器相关联，该转换器将至少一个信号(例如声音信号)传递给微处理器，微处理器构造成对该信号进行分析和处理。在另一种示例性实施例中，至少一个装置是模拟-数字转换器。
在一种示例性实施例中，描述了用于干粉吸入器的监视系统，包括:包括至少一个传感器的监视装置;模拟-数字转换器;数据储存介质，其中，该数据储存介质包括一组机器可读指令，这些指令可由处理装置执行以实现算法，其中，该算法包括用于对数据进行操纵的指令，所述操纵包括下列步骤:从至少一个传感器接收数据;对数据进行过滤;对数据进行变形;对数据进行分析;用该数据监视病人。
在一种示例性实施例中，至少一个传感器是话筒，该监视装置被设置在吸入器内的任何地方，例如在吸入器的壁内的空气导管内，或者在吸入器的外部作为单独的一件。在另一种示例性实施例中，监视装置还可以是可拆卸装置，其能够安装在干粉吸入器上或连接到干粉吸入器上。在另一种示例性实施例中，监视装置提供了图形显示，图形显示是吸入情况的实时图形表现形式。
在另一种示例性实施例中，声音信号是声音信号的幅度、声音信号的频率或它们的组合。在其他的示例性实施例中，传感器还在不同频率处对至少一个声音信号进行测量。在另一个示例性实施例中，干粉吸入器还包括药筒，该药筒可以包括用于肺部递送的干粉。而且，干粉还可以包括二酮哌嗪微粒和至少一种活性成分。在另一种实施例中，至少一种药剂包括胰岛素、GLP-1、甲状旁腺激素、降钙素、其类似物或其组合物。
在另一种实施例中，感知和/或监视装置被构造成从正被递送的剂量检测信号。在这种实施例中，感测和监视系统可以对粉末颗粒在使用中的吸入器和药筒系统内的、自粉末开始从药筒递送直到粉末颗粒递送结束的运动进行检测，其中，传感器对从吸入系统发出的吸入器声音和粉末颗粒声音的固有特性的变动进行检测。从检测记录所获得的数据可以被分析并关联到所发射或递送到吸入系统外的药剂量、药剂递送所经过的时间、以及吸入系统的性能。
在另一种示例性实施例中，感知和监视设备可以作为可适配、可拆卸的装置(例如护套或鞍状结构)而提供给干粉吸入器。在这种实施例中，可拆卸的装置便于对吸入系统的使用，因为干粉吸入器的结构或构造不用改变。因此，一旦已经确定了吸入器的特征性能并且对象能够合适地使用它，同一吸入器就可以在没有护套的情况下使用。在本申请中的实施例中，传感器(例如小的话筒)可以有利地置于套筒的任何区域，例如包括嵌入到套筒或适配器的壁中，或者从套筒的壁延伸。在这种实施例中，感知和监视设备对于从使用中的干粉吸入器和药筒系统发出的声音特性提供了更高的分辨率。
在一种示例性实施例中，描述了用于在吸入过程中对压力差异进行测量的方法，这些方法包括:给对象提供吸入器，其中，该吸入器包括传感器，该传感器被构造成对从吸入器产生的声音信号的至少一个幅度、声音信号的至少一个频率或它们的组合进行检测;使对象进行至少一秒钟的吸入;用计算机系统中的微处理器提供的算法对声音信号的所述至少一个幅度、声音信号的所述至少一个频率或它们的组合进行分析以产生数据集;以时间和压力的函数的形式显示、打印或储存该数据集。
本申请中描述的更多实施例是用于干粉吸入器的监视系统，这些系统包括:监视装置，包括至少一个传感器;模拟-数字转换器;数据储存介质，该数据储存介质包括一组机器可读指令，这些指令可由处理装置执行以实现算法，该算法包括用于对数据进行操纵的指令，所述操纵包括下列步骤:从所述至少一个传感器接收数据;对数据进行过滤;对数据进行变形;对数据进行分析;用该数据对病人进行监视。
本申请中描述的一种实施例中还有用于在吸入过程中测量压力差异的方法，这些方法包括:给对象提供吸入器，其中，该吸入器包括传感器，该传感器被构造成对从吸入器产生的声音信号的至少一个幅度、声音信号的至少一个频率或它们的组合进行检测，使对象进行至少一秒钟的吸入;用计算机系统提供的算法对声音信号的所述至少一个幅度、声音信号的所述至少一个频率或它们的组合进行分析以产生数据集;以时间和压力的函数的形式显示、打印或储存该数据集。
本申请中描述的其他实施例有用于对用户的吸入进行监视的交互式干粉吸入系统，这些系统包括:干粉吸入器，其包括药筒并具有每分钟0.065(√kPa)/升到每分钟0.200(√kPa)/升之间的流阻值;换能器，其构造成对吸入器在使用中产生的信号进行检测;显示装置，其构造成实时地显示由用户进行的吸入过程。在另一种实施例中，换能器感知和测量吸入器内的压力差异。此外，换能器还可以是流量计，其构造成对经过干粉吸入器的空气导管的流速进行感知和测量。换能器例如可以是话筒，其构造成对吸入器内产生的声音信号进行感知和测量。
本申请中描述的另外实施例是用于适配到干粉吸入器的感知和监视装置，这些装置包括可拆卸装置，可拆卸装置在结构上构造成适配到干粉吸入器;所述可拆卸装置包括用于对所述干粉吸入器中产生的声音进行检测的话筒;其中，干粉吸入器具有每分钟0.065(√kPa)/升到每分钟0.200(√kPa)/升之间的流阻值。
此外，在一种实施例中，描述了用于干粉吸入系统的感知和监视装置，其中，干粉吸入系统包括干粉吸入器和药筒，感知和监视装置包括话筒，该话筒被构造成对从干粉吸入系统发射的干粉配方所产生的声音信号进行检测。
附图说明
图1图示了干粉吸入器训练设备的一种实施例的右侧立体图。
图2图示了图1的实施例的左侧立体图，其中，壳体的一部分已被除去，以示出干粉吸入器训练装置的内部组件。
图3图示了图1的实施例的后视图。
图4图示了图1的实施例在除去装置罩子情况下的右侧立体图，示出了该装置内部的更多组件。
图5图示了本申请中公开的总体训练系统的框图。
图6以图形方式图示了由未受过训练的对象所进行的吸入过程。
图7以图形方式图示了只被训练进行深呼吸的对象所进行的吸入过程。
图8以图形方式图示了由对象进行的吸入过程，该对象用训练装置受到了使用干粉吸入器的合适训练。
图9A和图9B图示了吸入器在带有集成的感知和监视装置的情况下(图9B)和不带集成的感知和监视装置的情况下(图9A)的替换实施例的立体图。
图10图示了感知和/或监视装置的另一种可替换实施例的立体图，该装置作为被适配到干粉吸入器的套筒的一部分。
图11图示了图10所示感知和/或监视装置的立体图，其中，干粉吸入器系统被图示为处于开启构造。
图12图示了所示的感知和/或监视装置被安装到图10和图11所示干粉吸入器上的后视图。
图13图示了图12所示感知和/或监视装置的仰视图。
图14以经过其中心纵轴的剖面方式图示了在药筒就位、且装有感知和/或监视装置的情况下的干粉吸入器的侧视图。
图15图示了装有感知和/或监视装置的干粉吸入器的接近视图。
图16图示了图10-15所示感知和/或监视装置的实施例的立体图。
图17图示了用于适配到干粉吸入器的感知和/或监视装置的可替换实施例的立体图。
图18图示了本申请中所公开的总体示例性感知和/或监视系统的框图。
图19以图形方式图示了在相同的压力差异情况下测试的、由受到进行深呼吸训练的对象进行的吸入过程，并图示了带有干粉药剂和不带干粉药剂的曲线。
具体实施方式
本申请中公开了具有交互式系统的设备和/或装置以及方法，用于在吸入过程中对来自对象的压力或压降和/或流动中的实时改变进行测量或监视。这些装置可以用来训练对象，以结合吸入装置使它们的呼吸过程的效率尽可能高，还可以用来在递送药剂的过程中对吸气进行监视，从而对药剂是否被合适地递送、药剂递送的时刻以及所用吸入系统的性能是否合适进行检测。在一种示例性实施例中，可以与高阻吸入器相结合而应用感知和监视设备。
该设备包括换能器或传感器，能够将至少一个被测量转换成电信号，所述被测量包括压力、空气流、空气体积、湿度和温度。该装置还包括合适的信号调节电路(例如信号滤波、放大以及模拟-数字转换)、处理电路(例如微处理器)、有线的或无线的通信接口等，以实时地将所产生的信号传送到用于显示该信号的接收计算机或个人数据助理(PDA)。在一种实施例中，输出显示器可以是交互式显示器，使得该显示装置可以提供可视帮助，以实时地教导对象执行可重复的吸入过程，从而便于合适地对药剂进行吸入递送。在另一种示例性实施例中，数据可以被储存以在随后进行分析。
图1至图4图示了示例性的干粉吸入器训练装置。本申请中描述的训练装置交互式系统适用于高阻干粉吸入器，例如美国专利No.7,305,986和No.7,464,706、美国专利申请No.11/934,643(US2008/0053437)、No.11/949,707(US2008/0127970)、No.12/102,625中所公开的那些吸入器;美国专利申请No.12/413,405和No.12/484,125中公开了其他的高阻干粉吸入器，对于这些文献所公开的与干粉吸入器有关的全部内容，通过引用方式结合于此。
训练装置100包括执行器(activator)按钮102、壳体104、管嘴(mouthpiece)106、混合部108、混合部108上的帽或盖子110、空气入口112和空气出口114。空气入口112与空气出口114之间建立了空气导管。图2图示了将壳体104的左侧面板(未示出)除去的情况下的训练装置100，示出了壳体104内部的信号处理/接口板116和传感器118的位置。图3图示了训练装置100的后视图，示出了具有隔间的壳体104，该隔间用于容纳电源，并在右侧带有罩子120。
在一种示例性实施例中，模拟形式的传感器118被置于壳体104内，并在通过将执行器按钮102压下而开启训练装置100时检测来自训练装置100的压力差异，所述执行器按钮102连接到给系统供电的电源(例如图4所示的电池122)。传感器118可以被置于训练装置100的空气导管内的任意位置。在一些示例性实施例中，传感器118可以被置于壳体104内的空气导管中。在其他示例性实施例中，传感器118可以被置于混合室(未示出)内或管嘴106的空气导管内。
图5图示了吸入器训练装置(例如训练装置100)的框图，示出了其各个操作组件。在图5中，系统500包括两个组件，即吸入器训练装置502和处理系统504。处理系统504可以包括PDA或计算机506、显示器508、无线通信器510和输出端512，输出端可以是数字式储存装置、网络接口、打印输出装置等形式。在这种示例性实施例中，用户可以通过将电源按钮(例如训练装置100上的按钮102)压下而激活吸入器训练装置502，而处理系统504也被激活。当与计算机506一体的软件程序就绪时，启动信号出现在显示器508上。在系统被激活的情况下，吸入514在吸入器训练装置502中产生了压降，该压降由传感器118转化成电信号。在这种实施例中，传感器118可以是压力、流动、声音、光学、气体、湿度或温度换能器，可以是模拟式也可以是数字式。来自传感器118的电信号516然后被传送到信号调节器518以除去不需要的信号(例如信号噪声)。经过调节的电信号520然后被传送到信号放大器522，经过调节的电信号520可以在其中被放大到预定的电压范围，并作为经过放大的信号524而传送。经过放大的信号524然后经过模拟-数字转换器528而被转换成数字式信号526。数字式信号526然后经过微处理器530并通过连接设施534进入第二无线通信器532以传送到计算机506，计算机506具有无线通信器510以接收无线信号536。被内建/编程到微处理器530或计算机506中的软件程序将电信号516转换成能够以图形方式显示的压力值。在某些实施例中，提供了针对吸入器训练装置502的基线(baseline)曲线，作为参考标准来对用户的吸入过程进行引导。因此，在吸入期间，用户可以以可视方式将其吸入过程与该基线标准进行比较。这样，用户能够变更其吸入工作以符合该标准的要求。对于由对象执行的每次吸入所显示的数据可以经过第二连接设施538而保存到输出端512，数据可以在其中相应地储存或传输。例如，输出端512可以是闪存驱动器或打印机的形式，或者通过电子邮件而传送给医师以进行审阅或根据需要进一步训练。在一种实施例中，来自该吸入训练装置的信号可以被传送给该计算机/PDA，而来自该计算机/PDA的信号也可以由该吸入训练装置接收，从而在这两个组件之间建立双向通信。
此外，其他板上装置540可以经过一个或多个电缆542向微处理器530发送数据或从其接收数据。例如，其他板上装置可以包括数字式输出传感器、温度传感器、发光二极管(LED)、声音告警装置以及其他板上传感器。
也可以构建框图500的其他构造，例如，在信号放大之后，经过放大的信号524可以经过第二无线通信器532而直接发送给计算机506，计算机可以进行模拟-数字转换和其他所需的分析步骤。
图6至图8图示了对于对象的训练进程的示例性数据。每个图图示了在吸入过程之后，由本申请中描述的训练系统所显示的数据的曲线图(600、700、800)。这些曲线图是以kPa为单位的压力作为y轴、以毫秒为单位的时间作为x轴而绘制的。对于训练装置100的基线吸入性能标准如区域602所示，其边界是警告区域604以及可接受区域或优选区域606。区域602、604和606可以用不同的色彩来提供，以便于在吸入期间对个体的性能进行监视时识别这些区域。区域602例如可以由红色示出，表明吸入过程没有满足基线要求;因此，递送系统并未优化到有效地递送药剂。警告区域604可以由黄色示出，以表明对吸入过程接近不可接受的性能的警告。优选区域606可以由绿色示出，表明吸入性能处于有效递送药剂的可接受情形。
图6以图形方式图示了由对象执行的吸入过程的示例，该对象尚未接受过训练，并且在吸入过程中不被允许看到计算机的屏幕显示。这种吸入的结果如曲线608所示。如图6以图示方式所示，在整个吸入进程中，该对象的吸入过程落在不可接受区域602中。
图7以图形方式图示了由对象执行的吸入过程的结果，该对象接受了对于装置的使用的一些指导，并且在吸入过程中被允许观看显示了吸入过程的计算机屏幕。在该过程中，如曲线610所示，该对象的吸入进行了可接受的时间长度(如落在优选区域606内的端点612所示)，但是没有足够快地吸入，或没有进行足够的努力以获得可接受的值(如落在区域602内的区域614和616所示)。
图8以图形方式图示了由对象执行的吸入过程的示例，该对象已经接受了完整的训练，并且被允许在执行吸入的同时观看计算机上的显示屏幕。由曲线618可见，该对象的行为完全处于区域606内的可接受的值的范围内。
图6-9和图19所示的曲线图可以被包含到计算机程序中，并从其作为屏幕快照而捕获。可以使用计算机或微处理器来对本申请中所述装置和系统的其他特征进行控制并通过屏幕上的显示来使这些特征可视化。
在本申请中所述的一些示例性实施例中，一个或多个关键参数可以定义可接受的吸入过程，这些参数包括:总的吸入时间、峰值吸气压力、到达峰值吸气压力的时间、以及从峰值到总吸入时间的约75％期间的平均压力。在某些实施例中，总的吸入时间可以大于5秒，峰值吸气压力可以大于约6kPa，到达峰值吸气压力的时间可以小于约1.1秒，从峰值吸入到总吸入时间的75％期间的平均压力约4kPa。这些值是用于训练装置100的值的代表，对于其他的吸入器训练装置可以取决于性能参数而进行更改，所述性能参数是为了优化吸入器的药剂递送所需的，包括阻力。
在图9A和图9B所示的另一种示例性实施例中，干粉吸入器900可以设有感知和/或监视装置902，在病人进行的吸入过程中，该装置可以监视和/或感知由干粉吸入器900产生的或在干粉吸入器900内产生的信号。图9A图示了干粉吸入器900，其中，传感器装置没有被集成到该装置或连接到该装置。替代地，在图9B所示的示例性实施例中，监视装置902可以作为干粉吸入器900的一体部分而根据需要设置在管嘴904上或壳体906上。如图9B所示，干粉吸入器900具有适于装到吸入器内的监视装置902，该吸入器包括管嘴904和壳体906。在一种实施例中，该传感器可以被集成到吸入器900的组件壁(包括管嘴、壳体、滑轨)中，或突起到吸入器的流路之一中。干粉吸入器900包括空气导管，该空气导管具有空气入口908、空气出口910以及可选的管嘴罩912(图10)。监视装置902包括小型或微型的话筒，并被设在具有管嘴904的干粉吸入器900内，并设有引线914(图13)，引线可以连接到模拟-数字转换器、显示装置和/或计算机。
图10-图16图示了可替换的实施例，其中，干粉吸入器900包括以护套(jacket)或帽的形式呈现的、可拆卸的感知和监视装置1000，其中，可拆卸的感知和监视装置1000可以作为能够装到干粉吸入器的可拆卸零件而设置。在这种实施例中，护套被制造成单独的可拆卸装置，该装置包括传感器，这些传感器例如话筒，该话筒能够检测信号并能够储存、传递或显示这些信号。在一种实施例中，该传感器被置于护套的底部部分，如图12所示，使得该传感器被置于吸入器的空气导管中。在其他示例性实施例中，还可以设置与该传感器关联的无线装置。从使用中的有干粉或没有干粉的吸入器所发出的声波由该话筒检测，这些信号可以受到分析并取决于所用的传感器类型而关联到有干粉的情况下的粉末排放时间、空气流速、吸入过程中粉末排放的结束、吸入器路径内的温度等。例如，声音增大可以被关联到流经该装置的流速增大，和/或递送过程中空气流中的粉末颗粒碰撞。
传感器(例如话筒，因为其尺寸小)可以被置于吸入器中的任何地方。在以压力换能器作为传感器的实施例中，传感器可以被置于经过吸入器隔间之一的空气导管内。这些传感器例如可以被设置在吸入器上或吸入器内的空气导管中，或者以附件形式作为单独的可拆卸部件而设置到吸入器，该附件具有可以适于所要应用到的吸入器的形状或构造，并可以包括适配到或安装到吸入器的帽、护套、套筒或鞍状构造。对于这些可拆卸的实施例，感知和监视设备的制造是容易和便宜的，该设备可以由塑料制造，并很好地与高阻干粉吸入器一起工作。例如，在图10所示的实施例中，图12所示的传感器1202被设置在管嘴904的空气导管内。该传感器可以是任何传感器，例如热电偶丝、压力换能器、模拟传感器、话筒、光学传感器、气体传感器、或者能够对吸入器内产生的信号进行检测的任何传感器。传感器1202例如是话筒。本申请中描述的传感器可以适于用无线装置通信和传送信号，或者，这些信号也可以用有线连接设施916传送或储存到模拟-数字转换器。
或者，吸入器装置内设有模拟-数字转换器，所得的数字式数据被直接传送到该装置外部。由本申请中描述的传感器所提供的信号可以是吸入器内因为流经空气导管的空气流和/或空气流路中发生的粉末颗粒碰撞而产生的声音的形式。从吸入器产生的信号可以由这些传感器检测，并可以被储存、传送或显示。可以从这些信号产生数据，并可以对该数据进行定性和/或定量的分析。这样可以进行测量，这些测量包括剂量释放时间。
图11图示了图10所示感知和/或监视装置的立体图，其中，干粉吸入器900被图示为处于开启构造。干粉吸入器900包括管嘴904、壳体906以及用于将干粉吸入器900开启和关闭的铰链机构，该机构包括齿轮。管嘴904如图11所示移动到开启构造允许安装用于定量给药的药筒1102。管嘴904如图9所示移动到壳体906上进入干粉吸入器900的关闭位置或给药位置使药筒1102被重新配置到定量给药位置，形成了经过药筒1102和管嘴904的空气流路，其中，干粉吸入器900包括安装到该铰链机构的滑动托盘。
在一种示例性实施例中，在训练中或从病人的吸入过程收集信息时，可以由病人或医者根据需要来使用可拆卸的感知和监视装置1000(图12、13和16)，然后从干粉吸入器900拆卸该装置，而此时干粉吸入器900仍然可工作。图11图示了一种示例性实施例，其中，可拆卸的感知和监视装置1000被适配到管嘴904，使其稳固地装配，并在反复使用时不会在装在或卸载药筒1102的过程中移动。可拆卸的感知和监视装置1000可以在使用后被拆下，并可以根据需要而再次安装到另一吸入器上。在这种实施例中，可拆卸的系统提供了不会对吸入系统的特征阻值造成干扰和不利影响的简单装置。
图12图示了被从吸入器拆下的可拆卸的感知和监视装置1000的后视图，该装置在图10和图11中被示为安装到干粉吸入器900上。如图12所示，可拆卸的感知和监视装置1000被构造成具有第一凸缘1204和第二凸缘1206，二者都能够与管嘴904啮合，使得能够获得稳固的装配并且能够在处于关闭位置时通过留在干粉吸入器900上相应的第一槽918和第二槽920内而穿过壳体906。在这样的示例性实施例中，干粉吸入器900可以包括电线连接设施916或至少一个引线，该引线能够连接到模拟-数字转换器，使由可拆卸的感知和监视装置1000的横贯部1208上的传感器1202所检测的信号能够变换成数据。在可替换的示例性实施例中，可拆卸的感知和监视装置1000可以适配到无线发送器，以向收发器发送测得的信号。
图12和图16图示了被构造成鞍状的可拆卸的感知和监视装置1000，以对应于不同的干粉吸入器构造。可拆卸的感知和监视装置1000具有顶面1210、底面1212和传感器1202，传感器1202被沿中心纵轴布置在可拆卸的感知和监视装置1000的底面1212上。除了第一凸缘1204和第二凸缘1206外，可拆卸的感知和监视装置1000还可以包括至少一个锁销(detent)和至少一个突起1214，以啮合和适配到干粉吸入器900。在一种示例性实施例中，可拆卸的感知和监视装置1000包括抬高区域1216，该区域具有中空的下表面，并被构造来保持传感器线1302，以免对干粉吸入器900的空气导管中的空气流造成任何障碍。图13图示了可拆卸的感知和监视装置100的仰视图，图示了连接到传感器线1302的传感器1202以及用于连接到数字-模拟转换器的电线连接设施916。
图14图示了装有图11所示可拆卸的感知和监视装置1000的干粉吸入器900的剖视图。该剖面是在药筒1102在位的情况下经过其中心纵轴线取得的，示出了传感器1202在护套内的位置。图14和图15还示出了传感器1202(例如话筒)在管嘴904的空气流路中的位置。在一些实施例中，在用于适配到吸入器的空气流路的护套内，传感器可以取决于吸入器而被配置在不同的位置。这样，护套可以被构造成使传感器被集成为下述情况:当被适配到吸入器时，其位于吸入器的空气导管的上游、下游和中间，使得能够穿过吸入器的壁或直接在空气流路上检测到声音信号或振动。
图17图示了另一种可拆卸的监视装置1700的立体图，该装置被构造成适配到干粉吸入器(例如干粉吸入器900)。在这种示例性实施例中，第一侧面板1702和第二侧面板1704可以适配到管嘴904的第一吸入器侧面板922和第二吸入器侧面板924，从而与干粉吸入器900形成紧密配合。这种可拆卸的监视装置1700还包括第一底部凸缘1706、第二底部凸缘1708、第一前部凸缘1710和第二前部凸缘1712，用于与干粉吸入器900啮合。第一底部凸缘1706和第二底部凸缘1708夹持第一吸入器侧面板922和第二吸入器侧面板924的底部，而第一前部凸缘1710和第二前部凸缘1712夹持管嘴904的侧面并配合在干粉吸入器900上的第一槽918和第二槽920内。这种可拆卸的监视装置1700还包括抬高区域1714，以将传感器和附带的电线(未示出)容纳在其下表面中。夹持区域1718便于握持护套。
图18图示了对于本申请中描述的总体感知和/或监视装置和系统的示例性构造的框图1800。在这种示例性实施例中，吸入器1802包括话筒1804，以对用户吸入(1806)进行检测并提供模拟信号1808。在用户吸入(1806)期间，空气流在进入吸入器1802的空气导管时产生的声波由话筒1804检测到。话筒1804可以检测由于使用中的吸入器的压力、应力、颗粒位移和颗粒速度的变动而产生的声音信号，范围从15到20,000赫兹。话筒1804使用由所用的带有和不带有粉末的吸入器所固有地产生的频率发射中的改变或变动所造成的信号模式，来确定装置内的流速或压力，该流速或压力可在受到分析时关联到用户和/或装置性能。话筒1804中的这些振动信号然后被转换成模拟信号1808(例如电压)并被传送到模拟-数字转换器1810。来自模拟/数字转换器1812的信号被传递到设有微处理器的计算机/PDA1814，该计算机/PDA使用算法来对从模拟/数字转换器1812接收的信号进行分析。经过处理的数据由频率、时间和幅度参数呈现，并在显示器1816上提供或被提供给输出装置1818，用于储存以便将来使用、传递到基于网络的数字式储存装置、和/或打印输出。在这样的示例性实施例中，通过对信号频率随时间的关系进行监视，模拟信号1808的幅度可以被确定。每个干粉吸入器型号可以具有典型声学模式(或指纹)，该模式对于使用中的吸入器显现出来，然后该模式可以被检测并转换成具体的信号，受到分析并储存或显示在显示装置(例如计算机监视器)上。
在一种示例性实施例中，用于吸入器的感知和监视系统包括:在结构上构造成适配到吸入器的感知和/或监视装置;模拟-数字转换器;数据储存介质。数据储存介质包括盘驱动器、CD-ROM、服务器、闪存卡或驱动器、存储卡等，并包括一组机器可读指令，这些指令可由微处理器或其他处理装置来执行以实现算法。该算法在运行时发起下列步骤:产生从所检测的信号得到的逻辑子系统发生数;将逻辑子系统发生数保存到逻辑子系统内的数据轨道中，其中，逻辑子系统发生数以及该处理装置中的簇(cluster)发生数被进行比较;储存和/或显示作为吸入过程的结果而来自该算法的信息。
图19图示了响应于压力差异而用干粉吸入器系统执行的吸入过程的示例性图形显示1900，其中，该干粉吸入器系统包括话筒传感器。与图6-图9类似，图形显示1900具有可接受区域1902和不可接受区域1904。这些区域可以由红色和绿色或有助于了解吸入过程的任何其他颜色组合来着色。对象受到教导通过该吸入器进行约4到5秒长度的深呼吸，并被允许正常地呼气。该曲线图图示了来自该对象的吸气曲线，示出了使用图10-图16描述的感知和监视装置的测量结果。图19图示的数据以时间作为x轴，以压力差异作为y轴。
吸入过程是用具有药筒的吸入器进行的，第一曲线1906示出了该药筒不带干粉配方，而第二曲线1908示出该药筒带有干粉配方。这些结果表明，感知和监视装置能够对从系统发射的粉末的存在情况、粉末发射时间以及从系统发射的粉末量进行检测。曲线1906是在系统中没有粉末的吸入过程中由话筒产生的信号，而曲线1908是在系统中具有粉末的相同吸入过程中由话筒产生的信号。曲线1908与1906的差别代表了从系统发射的粉末的存在情况和数量，以及发射的时间。图19中的数据表明感知和监视装置对于测量从吸入器药筒系统发射的药剂量是有效的。
示例1
使用集成训练装置
一位57岁的II型糖尿病患者受到指导，从干粉吸入系统接收吸入的胰岛素，因为她的血红蛋白A1c较高并被认为失去了控制。病人受到训练以使用带有集成传感器的、如图9B所示的装置来进行吸入。将该装置给予病人并要求其使用该训练装置进行快速的深呼吸。
数据被收集在计算机上，病人能够实时地观看显示屏幕上的数据。病人的第一次吸入尝试太慢，并且在屏幕上被显示为进入了红色的“不可接受区域”。病人受到指导以进行比第一次尝试略快的另一次快速呼吸。在完成吸入后，曲线图表明该病人的吸入过程是可接受的，完全处于曲线图的绿色区域中。病人在对训练感到轻松的同时，清楚了对于类似装置的使用。
对该病人的处方是与图9A所示类型类似的干粉吸入器以及填充有可吸入胰岛素的药筒，以治疗该病人的糖尿病。在给予吸入胰岛素的处方六个月之后，该病人的糖尿病被诊断为得到了控制。
示例2
使用可拆卸的训练装置
一位59岁的II型糖尿病患者受到指导，从干粉吸入系统接收吸入的胰岛素。病人出于方便原因而要求了吸入系统。病人受到训练以使用图9A所示的装置来进行吸入。将装有与图12所示类似的可拆卸传感器的装置给予病人并要求其使用该训练装置进行快速的深呼吸。
数据被收集在计算机上，病人能够实时地观看显示屏幕上的数据。病人的第一次尝试是可接受的，如软件所示。病人在对训练感到轻松的同时，清楚了对于类似装置的使用。
病人可拆卸的传感器被从干粉吸入器拆下。将干粉吸入器以及填充有可吸入胰岛素的药筒给予该病人以治疗病人的糖尿病。在给予吸入胰岛素的处方六个月之后，该病人的糖尿病被诊断为得到了控制，病人对于该装置给予了“非常方便”的评论。
前面的公开内容是示例性的实施例。本领域技术人员应当明白，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明白，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(但不应认为试图限制将等同原则应用于权利要求的范围)，每个数值参数应当至少考虑所记载的有效数字并应用普通的取舍技术来解释。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测试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。
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。
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。
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 (15)

1.一种用于训练患者恰当使用干粉吸入器的传感器系统，包括：
可拆卸装置，所述可拆卸装置被构造成连接到所述干粉吸入器，所述可拆卸装置包括至少一个传感器，所述至少一个传感器被构造成对在吸入过程中由所述干粉吸入器产生的至少一个信号进行检测，并且处理和实时地产生对所述至少一个信号的显示，其中所述显示提供视觉提示以便于训练患者恰当使用所述干粉吸入器。
2.根据权利要求1所述的传感器系统，其中，所述可拆卸装置还被构造成向至少一个装置发送所述至少一个信号以进行分析、储存、打印和/或显示。
3.根据权利要求1或2所述的传感器系统，其中，所述至少一个信号是声音信号。
4.根据权利要求1所述的传感器系统，其中，所述至少一个传感器被构造成还对所述至少一个信号进行测量。
5.根据权利要求1所述的传感器系统，其中，所述至少一个传感器是话筒。
6.根据权利要求1所述的传感器系统，其中，由模拟－数字转换器将所述至少一个信号传递到微处理器，所述微处理器被构造成对所述至少一个信号进行分析和处理。
7.根据权利要求2所述的传感器系统，其中，所述至少一个装置是模拟－数字转换器。
8.根据权利要求2所述的传感器系统，其中，所述至少一个装置是显示装置。
9.根据权利要求1所述的传感器系统，其中，所述可拆卸装置包括与所述干粉吸入器的至少一部分相对应的鞍状形状。
10.根据权利要求1所述的传感器系统，其中，所述可拆卸装置适配于所述干粉吸入器的至少一部分。
11.根据权利要求9所述的传感器系统，其中，所述鞍状形状包括底面、和被构造成与所述干粉吸入器的至少一部分啮合的第一凸缘和第二凸缘。
12.根据权利要求11所述的传感器系统，其中，所述至少一个传感器构造成在所述底面中或所述底面上。
13.根据权利要求9或10所述的传感器系统，其中，所述至少一部分包括第一侧面板和第二侧面板。
14.根据权利要求9或10所述的传感器系统，其中，所述至少一部分是管嘴。
15.根据权利要求1所述的传感器系统，其中，所述干粉吸入器包括在结构上被构造成与所述干粉吸入器一起使用的药筒。
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