CN101888868B - 用于治疗睡眠呼吸暂停的方法和设备 - Google Patents
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Abstract
一种用于治疗睡眠呼吸暂停的通气设备被提供。由控制***控制的呼吸机可以经过通气气体传输管路传输通气气体至通气导管和通气导管的远侧末端部。一或多个传感器可以检测呼吸周期,并且控制***能以与呼吸周期同步的方式操作呼吸机。远侧末端部可以从经气管通气导管向上朝向上呼吸道、从经气管通气导管向下朝向肺或以二者的组合传输通气气体。通气导管可以是经气管导管、经口腔导管或经鼻导管。
Description
相关申请的交叉引用
本申请要求2007年9月26日提交的美国临时专利申请No.60/960,362的优先权,其内容整体上以引用方式并入本申请。本申请以引用方式并入了2004年6月17日提交的美国非临时专利申请No.10/870,849和2004年2月4日提交的美国非临时专利申请No.10/771,803,它们的内容都整体上以引用方式并入本申请。
技术领域
本发明涉及对遭受呼吸病变例如阻塞性睡眠呼吸暂停和中枢性睡眠呼吸暂停的人进行通气治疗。更具体地讲,本发明涉及利用通气导管恢复、增强或提供肺通气的方法和设备。
背景技术
本领域已知两种形式的睡眠呼吸暂停。中枢性睡眠呼吸暂停(CSA)是指呼吸的神经学动力损失。阻塞性睡眠呼吸暂停(OSA)症,是这两种形式中更常见的一种,其为上呼吸道的口咽区域物理阻塞。从形态学和神经肌肉学的角度看,组织结构可能会在睡眠中关闭并且保持关闭长时间段。这些呼吸暂停事件之后是突然的试图呼吸,这可能引起局部苏醒而达到浅睡眠状态。其结果是断续睡眠,以及更重要的,心血管疾病和其它疾病。传统OSA治疗方式是从压力发生单元传输连续的正呼吸道压力(CPAP),经过面部佩戴的面罩进行传输,由此传输正压力至呼吸道以保持呼吸道强制打开。
OSA治疗与其它所有形式的通气治疗相区别的独特之处是患者只能在睡眠中经受治疗。在睡眠中经受治疗要求治疗和所用设备舒适并且无阻碍以实现成功的治疗。CPAP需要亟待解决的问题是高阻碍性和不舒适,这使得大部分OSA患者不能得到治疗。
为了解决CPAP的局限性,尝试过其它治疗和干预措施。少量传统OSA治疗措施包括组织烧蚀,组织切断,下颌前伸器具,植入物,磁体,和组织抽吸装置。这些措施都旨在防止口咽呼吸道阻塞,然而,都存在缺陷。烧蚀和切断不实用,因为呼吸道的大部分需要被去除或缩小,因而影响其它呼吸道功能,例如吞咽和讲话。植入物和磁体不实用,因为手术过程和设备要么不足以获得防止阻塞的解剖学效果,要么解剖学效果太大而负面影响其它呼吸道功能。抽吸装置和口腔器具不实用,因为它们不是使用者友好型的。
需要有安全且有效的方式来防止阻塞,与此同时保留口-咽呼吸道的功能并且避免任何负面作用。还需要使得所用方法和设备是低阻塞且更舒适的。
其它使用导管或套管的基于通气的治疗途径也在现有技术中描述过。Jacobs(″Transtracheal Catheter Ventilation:Clinical Experience in 36Patients″;Chest 1974;65;36-40)描述了利用经气管导管为非自发呼吸患者通气。McGinley(″A nasal cannula can be used to treat obstructivesleep apnea″;Am J Respir Crit Care Med.2007 Jul 15;176(2):194-200)描述了利用改进的氧气治疗鼻叉件经鼻传输氧气来实现夜间治疗OSA。Christopher(″Oxygen Therapy Using Pulse and Continuous FlowWith a Transtracheal Catheter and a Nasal Cannula″;Chest 1994;106:854-860)描述了利用经气管导管治疗依赖氧气的患者以使得氧气传输治疗与保存氧气同步化。Breitenbucher(″Transtracheal oxygentherapy in obstructive sleep apnea syndrome″;Schweiz Med Wochenschr.1989 Nov 18;119(46):1638-41)描述了利用经气管套管实现气体连续流动而进行夜间治疗OSA。Christopher(美国专利公开文献No.2005/0121038)描述了将鼻导管朝向咽进给以直接向咽通气。Christopher(美国专利No.5,954,050)描述了经气管诊断导管,其配备有呼吸传感器,用于诊断睡眠呼吸暂停同时提供连续流氧气治疗。
尽管这些基于导管的措施取得了一些临床成功,但它们不足以在主流治疗中采用。基于鼻套管的措施趋向于有效治疗打鼾和轻度OSA,但对于中度和重度OSA是无效的,因为其在口咽处产生的压力是有限的。经气管措施趋向于利用精度和控制***智能来使得治疗对于一定范围的患者和临床条件有效,但也不能以最优的方式引导通气气体。
需要有一些有效的途径来利用基于导管通气的***和方法防止或治愈睡眠呼吸暂停,以克服前述缺点。
发明内容
本发明对现有的睡眠呼吸暂停通气治疗进行了改进。本发明利用基于导管的***防止呼吸道阻塞,或是在阻塞期间为肺通气,该***的阻力低于CPAP,从而可提高治疗中的顺应性和效率。
此外,本发明提供了改进的呼吸暂停症状发作的预见性,从而使得治疗能够以更精确、智能和更大患者适应性的方式实现干预。本发明的实施方式可以包括一或多个下述特征:(1)基于导管的同步化肺和/或口咽呼吸道通气;(2)基于导管的口咽呼吸道增压以防止或逆转呼吸道阻塞;(3)口咽呼吸道逆行通气;(4)利用呼吸动作和呼吸传感器进行呼吸暂停预测和检测,并且调节治疗参数。
本发明的实施方式可以包括用于治疗睡眠呼吸暂停的设备,其具有用于传输通气气体的呼吸机;用于呼吸机的控制***;用于***气管中的经气管通气导管;所述经气管通气导管上的远侧末端部;用于检测呼吸周期的一或多个传感器;将呼吸机连接至经气管通气导管的通气气体传输管路;其中,控制***操作呼吸机以使得通气气体以与呼吸周期同步的方式传输;并且,远侧末端部沿着选自下面一组的方向传输通气气体:从经气管通气导管向上朝向上呼吸道,从经气管通气导管向下朝向肺,以及它们的组合。
控制***可以操作呼吸机,以使得通气气体以选自下面一组的方式传输:在呼吸周期的吸气相态中,在呼吸周期的呼气相态中,在呼吸周期的吸气相态和呼气相态二者中,在呼吸周期中连续地,在呼吸周期中循环地,流量幅值随时间增加,控制***响应于来自所述一或多个传感器的测量值调节流率,以及它们的组合。通气气体能以低流率和高压力传输,或以高频率传输。通气气体能以喷流的形式传输。通气气体能以选自下面一组的方式传输:抢先进行以防止或最小化阻塞或呼吸暂停事件,在阻塞或呼吸暂停事件发展的过程中,对阻塞或呼吸暂停事件作出反应而进行,以及它们的组合。
一或多个传感器可以连接至经气管通气导管,或位于气管外面。一或多个传感器可以是气管中的一或多个气流传感器和气管中的一或多个压力传感器。来自所述一或多个气流传感器的信号和来自所述一或多个压力传感器的信号可以被控制***组合以启动呼吸机。一或多个传感器可以是第一传感器,用于测量实际呼吸空气动作和第二传感器,用于测量直接或间接呼吸肌肉作用,并且,控制***处理来自第一传感器和第二传感器的信号以区分选自下面一组的状况:轻呼吸,阻塞,减弱呼吸动力,以及它们的组合;其中,如果第一传感器测量到某一信号的幅值异常低且第二传感器同时测量到某一信号的幅值异常高,控制***启动呼吸机以便传输通气气体。
所述设备可以包括加湿器。通气导管可以穿过造口导向件。远侧末端部可以在气管中朝向上呼吸道向上弯曲。经气管通气导管包括具有选自下面一组的功能的多重管腔:朝向肺传输气体,朝向上呼吸道并且背离肺传输气体,监视气管压力,容置呼吸传感器配线,或它们的组合。远侧末端部可以包括两个通气气体排出端口,其中,第一气体排出端口朝向肺引导通气气体,第二气体排出端口背离肺朝向上呼吸道向上引导气体。远侧末端部可以包括双分支,其中,双分支的第一部分向下朝向肺弯曲或弯折,双分支的第二部分向上背离肺朝向上呼吸道弯曲或弯折。通气设备可以在日间利用第一组参数以第一模式操作,用于呼吸功能不全,而在夜间在睡眠过程中利用第二组参数以第二模式操作。
本发明的实施方式可以包括治疗睡眠呼吸暂停的方法,其包括借助于远侧末端部将经气管通气导管***气管中;利用一或多个传感器测量呼吸周期;利用控制***基于来自所述一或多个传感器的信号控制呼吸机;以与呼吸周期同步的方式经过通气气体传输管路从呼吸机传输通气气体至经气管通气导管;并且,所述经气管通气导管的远侧末端部沿着选自下面一组的方向引导通气气体:从经气管通气导管向上朝向上呼吸道,从经气管通气导管向下朝向肺,以及它们的组合。
本发明的实施方式可以包括用于治疗睡眠呼吸暂停的通气设备,其包括:用于传输通气气体的呼吸机;用于呼吸机的控制***;用于***口腔中的经口腔通气导管;经口腔通气导管上的远侧末端部;一或多个第一传感器;一或多个第二传感器;其中,来自所述一或多个第一传感器的信号和来自所述一或多个第二传感器的信号被组合以确定呼吸周期;通气气体传输管路将呼吸机连接至经口腔通气导管;其中,控制***操作呼吸机以使得通气气体以与呼吸周期同步的方式传输;并且,远侧末端部从经口腔通气导管沿着向下方向朝向肺传输通气气体。
本发明的实施方式可以包括治疗睡眠呼吸暂停的方法,其包括借助于远侧末端部将经口腔通气导管***口腔;利用一或多个第一传感器和一或多个第二传感器测量呼吸周期;利用控制***基于来自所述一或多个第一传感器的信号和来自所述一或多个第二传感器的信号控制呼吸机;以与呼吸周期同步的方式经过通气气体传输管路从呼吸机传输通气气体至经口腔通气导管;并且,经口腔通气导管的远侧末端部从经口腔通气导管朝向肺沿着向下方向引导通气气体。
本发明的实施方式可以包括用于治疗睡眠呼吸暂停的通气设备,其包括:用于传输通气气体的呼吸机;用于呼吸机的控制***;用于***鼻腔中的经鼻通气导管;所述鼻-口通气导管上的远侧末端部;一或多个第一传感器;一或多个第二传感器;其中,来自所述一或多个第一传感器的信号和来自所述一或多个第二传感器的信号被组合以确定呼吸周期;利用通气气体传输管路将呼吸机连接至经鼻通气导管;其中,控制***操作呼吸机以使得通气气体以与呼吸周期同步的方式传输;并且,远侧末端部沿着向下方向从经鼻通气导管朝向肺传输通气气体。
本发明的实施方式可以包括治疗睡眠呼吸暂停的方法,其包括借助于远侧末端部将经鼻通气导管***鼻腔中;利用一或多个第一传感器和一或多个第二传感器测量呼吸周期;基于来自所述一或多个第一传感器的信号和来自所述一或多个第二传感器的信号利用控制***控制呼吸机;以与呼吸周期同步的方式经过通气气体传输管路从呼吸机传输通气气体至经鼻通气导管;并且,经鼻通气导管的远侧末端部从经口腔通气导管朝向肺沿着向下方向引导通气气体。
本发明的其它特征、优点和实施方式可从下面的详细描述、附图和权利要求书中清楚地体现出来。此外,可以理解,前面的发明内容和下面的具体实施方式都是示例性的,旨在提供进一步的解释,而不对请求保护的本发明构成限制。
附图说明
为了进一步理解本发明而提供并且结合于此构成本说明书一部分的附图示出了本发明的优选实施方式,并且与下面的具体实施方式部分一起用来解释本发明的原理。在附图中:
图1是示意图,示出了现有技术利用CPAP治疗措施来治疗OSA。
图2a是示意图,示出了用于治疗OSA的经气管通气方法和设备,该设备包括经气管通气导管、气体传输管路、呼吸检测元件、呼吸机和通气控制***。
图2b描绘了图2a中的通气导管和气体传输管路的进一步细节,其中呼吸检测是通过压力检测管腔实施的。
图2c描绘了图2b的替代性方案,其中检测是利用有源呼吸管内传感器实施的。
图2d描绘了图2c的替代性方案,其中检测是利用有源呼吸管内传感器和压力检测管腔实施的。
图3是曲线图,示出了经气管通气被启动以对阻塞或呼吸暂停事件作出反应而进行。
图4是曲线图,示出了在预期出现阻塞或呼吸暂停事件之前经气管通气被启动。
图5是曲线图,示出了经气管通气被抢先启动以防止阻塞或呼吸暂停事件。
图6是曲线图,示出了经气管通气被启动以减轻阻塞或呼吸暂停事件,其中通气气体被与呼吸周期的吸气相态同步化。
图7是曲线图,示出了经气管通气被启动以减轻阻塞或呼吸暂停事件,其中通气气体被以连续流的形式传输。
图8是曲线图,示出了经气管通气被启动以减轻阻塞或呼吸暂停事件,其中通气气体被定期传输,传输期可从患者的呼吸率的过去历史预测出来,或是以预定流率传输并且可能与患者的呼吸动作不同步。
图9是曲线图,示出了经气管通气被启动以减轻阻塞或呼吸暂停事件,其中通气气体被与呼吸周期的吸气相态同步化,并且通气气体传输具有可变的逐渐增大的强度,例如体积、速度或压力,直至阻塞的减轻被检测到,此时通气气体传输强度减弱。
图10是曲线图,示出了经气管体积传输被抢先启动以有助于防止阻塞或呼吸暂停事件,其中当阻塞或呼吸暂停事件出现时,经气管通气气体流在吸气相态中的体积传输与体积传输之间的连续流之间交替进行。
图11是曲线图,示出了经气管通气被利用连续流抢先启动,以有助于防止阻塞或呼吸暂停事件或有助于防止淡化,并且当阻塞或呼吸暂停事件出现时,经气管通气气体流在吸气相态中的体积传输与体积传输之间的连续流之间交替进行。
图12是曲线图,示出了经气管通气被以连续流抢先启动,以有助于防止阻塞或呼吸暂停事件或有助于防止淡化,并且,在阻塞或呼吸暂停事件被检测到后连续流的幅值增加,并且在呼吸暂停事件被纠正后减弱。
图13是曲线图,示出了经气管通气被启动以减轻阻塞或呼吸暂停事件,其中,通气气体以与患者的呼气相态同步的方式传输,并且通气气体被沿逆行方向传输,即背离肺且朝向口咽呼吸道。
图14a是曲线图,示出了经气管通气被同步化以便在吸气相态中的向肺传输增强作用,并且在呼气过程中沿逆行方向朝向口咽呼吸道传输增强作用。
图14b是曲线图,示出了经气管通气被同步化以便在吸气相态中且在呼气相态中向肺传输增强作用。
图15a是曲线图,示出了经气管通气被同步化以便在呼气相态中向肺传输增强作用,并且在吸气相态中沿逆行方向朝向口咽呼吸道传输增强作用。
图15b是曲线图,示出了经气管通气被同步化以便在吸气相态中沿逆行方向朝向口咽呼吸道传输增强作用并且在呼气相态中传输增强作用。
图16a是示意图,示出了逆行经气管通气方法和设备,用于治疗阻塞性睡眠呼吸暂停,其中通气气体被以逆行方式朝向口咽呼吸道传输。
图16b描绘了图16a中的逆行导管。
图17a是示意图,示出了经气管通气设备和方法,用于治疗阻塞性睡眠呼吸暂停,其中呼吸机和双向经气管导管被构造成沿肺和口咽呼吸道二者的方向传输气体。
图17b描绘了图16a中的呼吸机,其中远侧末端部向上弯曲。
图18a和18b是示意图,示出了双向通气导管,其中导管远侧末端部沿逆行流方向朝向图17a中的口咽呼吸道弯曲,具有两个管腔被用于双向流。
图19a和19b是示意图,示出了图17a中的双向通气导管,具有两个管腔和双向末端。
图19c是示意图,示出了图17a中的双向通气导管,其中远侧末端部弯曲向下。
图19d是示意图,示出了17a中的双向通气导管图,其中远侧末端部弯曲大于210度。
图20是曲线图,示出了经气管通气被启动以减轻阻塞或呼吸暂停事件,其中指向肺的增强流被与患者的吸气周期同步化,而逆行流被与患者的呼气周期同步化。
图21是曲线图,示出了经气管通气被启动以减轻阻塞或呼吸暂停事件,其中指向肺的增强流和指向口咽呼吸道的逆行流二者被与患者的吸气周期同步化。
图22是曲线图,示出了经气管通气被启动以减轻阻塞或呼吸暂停事件,其中指向肺的增强流被与患者的吸气周期同步化,而朝向口咽呼吸道的逆行流被以高频率体积震荡的形式传输。
图23是曲线图,示出了经气管通气被启动以减轻潜在的阻塞或呼吸暂停事件,其中指向肺的增强流被与患者的无阻呼吸中的吸气周期同步化,并且逆行连续增加的气流被朝向口咽呼吸道传输。
图24a和24b是示意图,示出了用于治疗睡眠呼吸暂停的经口腔通气方法、呼吸机和导管。
图25a和25b是示意图,示出了用于治疗睡眠呼吸暂停的经鼻通气方法、呼吸机和导管。
图26是示意图,示出了用于治疗OSA的经气管通气方法、呼吸机和导管,包括外部呼吸传感器以检测呼吸以及阻塞或呼吸暂停事件。
图27是曲线图,示出了在一段时间内施加经气管通气方法。
附图中的附图标记列表
L 肺
T 气管
V 呼吸机
VO 呼吸机气体出口
OA 口咽呼吸道
UA 上呼吸道
IQ 吸气流
EQ 呼气流
IP 吸气压力
EP 呼气压力
A 通气流
R 逆行气体流
T 时间
Q 呼吸道气流信号
P 呼吸道压力信号
I 下侧
S 上侧
5 通气导管颈凸缘
7 连接件
8口咽阻塞部
10经气管导管
10′具有逆行流的经气管导管
10″具有正常和逆行流的经气管导管
11向下气体排出端口
12造口
15向上气体排出端口
20通气气体传输管路
20′气体传输管路
20″气体传输管路
32正常气流信号
34减弱的气流信号
38增强的呼吸动作信号
40呼吸机流量/体积与吸气同步
42连续流
43增大的呼吸机连续气流信号
44基于以往呼吸率历史的呼吸机流量/体积速度
45沿逆行方向的呼吸机体积
46以与呼气同步的方式呼吸机流量/体积
47循环体积传输
48受阻呼吸信号
49逆行高频率体积传输
50逆行斜坡连续增加的气流传输
60近端连接器
61气体传输通道连接器
62呼吸传感器连接器压力
63监视管腔连接器
64主通道
65副管腔
66传输管路气动检测管腔
67组合连接器
68可拆卸连接器
70CPAP通气罩
72CPAP呼吸机
74CPAP单管式呼吸管路
75罩通气口
76气流发生器
77压力传感器
78控制***
79控制阀
80气管内气流传感器
82传感器配线
84传感器配线管腔
86管压力检测口
88压力检测管腔
90导管远侧末端节流器
92导管远侧末端段
100逆行导管
120组合逆行和正常方向通气导管
121气体传输通道
123气体传输通道
125组合逆行和正常方向气体传输管腔
130造口导向件
131造口导向件颈凸缘
133造口导向件护板
135造口导向件系带
136造口导向件键槽
160气体传输压力传感器
161气体传输机构
162压力监视管线
163气体传输控制***
165气体传输控制阀
168加湿器
169患者自发呼吸传感器
170双路控制阀
171肺指向阀气体出口
172逆行指向阀气体出口
180双路连接器
181肺指向气体流连接器
182逆行指向气体流连接器
200经鼻导管
220经口腔导管
222舌凸缘
224颊凸缘
225通气管路颈部系带
230口呼吸传感器
232口内呼吸传感器
234鼻呼吸传感器
235凸缘
236鼻内呼吸传感器
300外部气流传感器
302外部气流传感器紧固带或头部系带
304外部气流传感器无线传送信号
306外部气流传感器信号线
308呼吸机气流传感器信号接收器
310无线外部呼吸动作传感器
312外部呼吸动作传感器
314外部呼吸动作传感器配线
具体实施方式
图1示出了一种连续正呼吸道压力(CPAP)***,其为用于治疗阻塞性睡眠呼吸暂停(OSA)的现有技术治疗方式。当口咽阻塞部8出现后,患者就不能通过他们的口或鼻自发呼吸了。口咽阻塞部8可以出现在气管(T)和上呼吸道(UA)上方。为了治疗,CPAP被利用CPAP呼吸机72、CPAP单管式呼吸管路74和具有一或多个罩通气口75的CPAP通气罩70传输。压力气体被传输至上呼吸道(UA)以防止口咽呼吸道(OA)被阻塞。被患者的肺接收的所有气体都来自CPAP呼吸机72,因为CPAP***是封闭***。压力气体由CPAP呼吸机72中的压力或气流发生器76(典型地吹风机)产生。在呼气过程中,患者排气通过所述一或多个罩通气口75,并且通过CPAP单管式呼吸管路74返回。CPAP呼吸机72还包括压力传感器77、控制***78和控制阀79,用于控制CPAP呼吸机72。CPAP治疗不受欢迎,这是由于封闭***的侵袭性,佩戴面罩带来的阻塞,正压力传输和呼气的非自然感受,和额外的人工加热加湿措施(未示出)。
图2-27示出了本发明的各种实施方式。
图2示出了本发明的一种实施方式,其中最小侵袭性开放式呼吸道经气管通气***可以被使用,以防止、最小化或逆转上呼吸道阻塞,或在阻塞时提供通气。本发明可以包括呼吸机(V),其具有气体传输机构161、气体传输控制***163、气体传输控制阀165、气体传输压力传感器160和患者自发呼吸传感器169。
气体传输机构161可包括活塞、吹风机、泵、气体蓄积器、压力气体源或液态氧气源,或者可以简单地是来自外部气体源的输出件。气体传输机构161的输出可以由气体传输控制阀165或比例阀控制。气体传输控制***163可以从位于呼吸机内部的呼吸传感器和位于呼吸机外部的呼吸传感器之一或二者接收信息,例如,气管内呼吸道传感器80,如图所示,或是压力检测管腔,如后文所述。气体传输控制***163可以接收来自气体传输压力传感器160和/或呼吸传感器或其它传感器的输入。气体传输控制***163可以控制通气气体传输机构161和气体传输控制阀165以向患者提供期望的治疗输出和作用。
本发明还包括通气气体传输管路20和经气管导管10,经气管导管可以包括呼吸传感器,例如,气管内气流传感器80。通气气体可以是空气、氧气或混合的空气和氧气。湿气可从可选的加湿器168供应至气体传输管路中。
诸如气管内气流传感器80的一或多个呼吸传感器以及气体传输控制***165对于下述功能可能是非常重要的:监视患者的呼吸,预测或检测阻塞或呼吸暂停事件的存在,和将呼吸机(V)输出与患者的呼吸同步化。一或多个呼吸传感器可测量气管(T)中的空气流量,测量气管的压力,或二者。当测量空气流量时,气流信号在上呼吸道出现阻塞时减小,因为阻塞会减少通过气管的实际气流。当测量压力,气管压力信号可在出现阻塞时增加,因为气管中会出现压降增大。如本申请通篇描述,双重检测措施可能是优选的,因为一个传感器被用于测量实际呼吸,而另一传感器被用于测量呼吸动作。这两个测量值的组合可允许***区分呼吸暂停和轻呼吸,区分OSA和CSA。两个测量***可以比单一传感器提供更多的预测信息。例如,实际呼吸可通过检测气管中的气流而被检测,而呼吸动作可通过测量气管的压力或胸部运动而被检测。
一或多个气管内气流传感器80可以是,例如,一或多个热传感器,其检测气管T中的气流方向,压力传感器,例如应变传感器,压力监视管腔,其终止于压力监视端口,气流传感器,例如热线式风速计,加速度传感器,或气体成分传感器例如CO2传感器。一或多个气管内气流传感器80可以可选地与组织接触。如果所述一或多个气管内气流传感器80与组织接触,它们可以是,例如,脉搏血氧饱和度传感器,应变传感器,肌肉活动传感器,或神经传感器。一或多个气管内气流传感器80还可以可选地位于经气管导管外部(参看,例如,图26中的元件300)。在这种情况下,一或多个气管内气流传感器80可以是鼻或口热传感器或气流传感器,或胸阻抗传感器,例如RespiTrace传感器。
经气管导管10可以通过造口12安放到患者颈中并且进入气管(T)。可选地,造口导向件130可以被置入造口12中,且经气管导管10被置入造口导向件130中以允许更容易根据需要拆除和重新***经气管导管10。造口导向件130可以典型地包括位于外侧近端的一或多个凸缘或护板,以及可选地位于内侧远端的一或多个凸缘或护板,以将造口导向件130紧固就位于颈和造口12中。经气管导管10可以典型地包括颈凸缘5以将经气管导管10紧固至造口导向件130或颈,和将连接件7紧固至气体传输管路20。通气流可以在远侧末端部气体排出端口11处离开经气管导管10。气体排出端口11可以朝向肺(L)引导通气流(A)。
患者可以大致具有吸气流(IQ)和呼气流(EQ)。除了吸气流(IQ)和呼气流(EQ),本发明的通气流(A)可以描述为增强气流或增强通气;然而,这仅仅是示例性的,并且通气可以包括更高级别的体积,并且可以简单地认为仅仅是通气。通气气体传输可是:(1)可增强患者的自发潮气量(tidal volume)的体积级别,例如50ml至200ml;(2)足够量的患者所需的休息状态潮气量,例如150ml至300ml;(3)全部休息状态潮气量,例如350ml至600ml;(4)超出患者正常休息状态潮气量的体积,例如400ml至800ml;或(5)其它适宜体积。
经气管导管10和通气气体传输管路20被进一步详细描述于图2b-2d。在图2b中,通气气体传输管路20可以包括近端连接器60,其进一步包括气体传输通道连接器61和呼吸传感器连接器62。通气气体传输管路20可以包括用于气体传输的主通道64和用于传送呼吸传感器信号的副管腔65。压力监视管腔连接器63可以安置在组合连接器67中并且与传输管路气动检测管腔67连通。通气气体传输管路20可以利用靠近患者的可拆卸连接器68或备选地永久性附连于经气管导管10的连接器连接至经气管导管10。如果经气管导管10直接***患者的造口12,经气管导管10可以包括通气导管颈凸缘5。然而,利用经气管导管10和造口12之间的造口导向件130,也是可行的,如后面所解释。
经气管导管10可以包括气体传输通道123、压力检测管腔88和压力检测口86。经气管导管可以弯曲从而使得导管远侧末端段92平行于气管(T)的轴线,典型地以90-110度弯角弯曲。如果希望具有文丘里效应,导管远侧末端段92可以包括位于排出点的导管远侧末端节流器90以增大通气流(A)的排出速度。压力检测管腔88可选地可以利用典型地包含在呼吸机(V)中的冲洗机构来冲洗以维持敞开。其它类型的传感器设计将在后面进行描述并且可以用在本发明的任何实施方式中。压力检测口86可以平行于气管的纵向轴线定位以减少与方向性相关的人为因素。压力检测口86的其它可行位置和定向将在下面描述。
可选地,压力检测口86可被定位成正交于气管的纵向轴线,例如位于经气管导管10的顶表面或上表面(S)。向上定向可以提供对吸入气流的敏感读取和对于呼出气流的较不敏感读取,这可能是由于文丘里效应。如果认为吸气过程中的精度更为重要,则压力检测口86可定位在上表面上。然而,如果认为在呼气过程中的精度更为重要,则压力检测口86可定位在经气管导管10的下表面(I)上。备选地,经气管导管10可配备有两个压力检测口86,其连接至压力检测管腔88,因而这两个压力检测口86得到的信号可以组合成一个平均信号。备选地,经气管导管10可配备有两个压力检测口86,一个位于下表面(I)上,另一个位于上表面(S)上,其中每个压力检测口86连接至专用压力检测管腔88,这两个压力检测管腔连接至呼吸机(V)中的两个专用压力换能器。这种配置可以为呼气(下侧检测口)和吸气(上侧检测口)二者提供高精度。这种配置还可被用以确定流量。
图2c示出了替代性的具有逆行流的经气管导管10′和气体传输管路20′。在本例中,具有逆行流的经气管导管10′可以包括气管内气流传感器80。气管内气流传感器80通过安置在具有逆行流的经气管导管10′内的传感器配线管腔84中的一或多个传感器配线82和气体传输管路20′中的管件85而与呼吸机(V)连通。在图2c中,气管内气流传感器80可以包括有源元件例如,但不局限于,热学、机械、电学、化学或光学元件。还是在图2c中,造口导向件130可以安置在具有逆行流的经气管导管10′和造口12之间。造口导向件130可以包括位于颈部表面上的造口导向件颈凸缘131或护板和将造口导向件130紧固就位的造口导向件系带135。造口导向件130可以可选地包括位于气管(T)内侧的凸缘或一或多个造口导向件护板133以防止脱开。造口导向件130可包括造口导向件键槽136,其与具有逆行流的经气管导管10′上的配合特征相配合,以将替换的具有逆行流的经气管导管10′可旋转地正确定向。替换的具有逆行流的经气管导管10′可以通过通气导管颈凸缘5连接至造口导向件130。
图2d示出了替代性导管设计,其中具有正常和逆行流的经气管导管10″包括带压力检测口86的有源气管内气流传感器80和压力检测管腔88。在这种情况下,例如,气管内气流传感器80可被用于测量一个呼吸参数,例如空气流量或气体成分,而压力检测口86可被用于测量不同的呼吸参数,例如气管压力或呼吸动作。气体传输管路20″可以具有所需的连接件用于连接至呼吸机(V)。连接件可以包括气体传输通道连接器61、气动压力检测连接器63和呼吸传感器连接器62。
图2a-2d中的经气管导管10、10′、10″可以包括一或多个弯曲部以将远侧末端部以无刺激方式定位在气管管腔中。通过减少或消除经气管导管与气管壁的接触,刺激可以最小化。备选地,通过经气管导管与气管壁接触但减少或消除抵靠着气管壁的移动,刺激可以最小化。如果经气管导管和气管壁之间没有移动接触,并且最优选地,如果经气管导管和气管壁特别是后气管壁之间没有接触,降低刺激可以最佳地实现。理想地,经气管导管被设计成在***部分带有大约90度-120度的弯曲段,以使得导管远侧末端段弯曲成与气管(T)的轴线对正,并且朝向主支气管引导导管末端。
经气管导管10、10′、10″的长度可以朝向皮肤远侧延伸一段大约10-200mm、优选大约20-100mm的距离;并且通气导管的外径(OD)可以为大约3-10mm,优选大约4-6mm 而通气导管10的内径(ID)可以为大约0.75-3mm,优选大约1-2mm。
经气管导管10、10′、10″可以具有一个气体传输通道123。经气管导管可以具有用于传感器配线82和/或用于压力检测管腔88的副管腔84。经气管导管10、10′、10″可以由热塑性材料例如PVC、基于尼龙的材料或PVC-聚氨酯混合物模制、挤出或成形出来,或者备选地,可以利用弹性体材料例如硅酮或聚氨酯模制。经气管导管材料可以典型地具有大约30-90邵氏(Shore)A硬度。经气管导管末端可以倒圆以提供防损伤表面。远侧末端部的ID可选地缩减至大约10-75%,优选40-60%,以增大气体流排出速度,这在需要文丘里效应时是理想的。
气体传输管路20、20′、20″的长度可以为大约20-100英寸,优选大约30-40英寸,OD为大约6-16mm,优选大约6-10mm,而ID为大约2-10mm,优选大约3-5mm。气体传输管路20、20′、20″可以是非常轻质的挤出热塑性材料例如聚丙烯或聚乙烯。
图3-5和27利用曲线图示出了示于图2a的实施方式的呼吸检测元件、通气控制和气体传输等方面。这一系列曲线图显示了本发明的各种备选气体传输方法:图3示出了经气管通气响应于呼吸暂停事件;图4示出了经气管通气响应于呼吸暂停事件的开始或前兆,以防止呼吸暂停事件加重;图5示出了经气管通气抢先进行以预先应对呼吸暂停事件;而图27示出了在呼吸暂停或呼吸道阻塞期间启动经气管通气,然后在呼吸恢复后结束经气管通气。在这一系列曲线图中,t为时间轴,Q为呼吸道气流信号,IQ为吸气流信号,EQ为呼气流信号,VO为呼吸机输出,32为正常呼吸流量曲线,34为当呼吸道出现局部阻塞时的呼吸流量曲线,而48为有阻塞的气流信号。
图3利用曲线图示出了经气管通气启动以对阻塞或呼吸暂停事件作出反应而进行。一或多个气管内气流传感器80可以检测出气管气流从正常气流信号32漂移至减弱的气流信号34。如标以″有干预″的曲线所示,在减弱的气流信号34由呼吸传感器检测到之后马上或是在经历了一段预期的延迟之后,气体传输控制***163可以命令呼吸机(V)以基于以往呼吸率历史的流量44传输通气流/体积。通气流A会打开阻塞并且恢复呼吸,如标以″有干预″的曲线所示,并且恢复通气至肺(L)和肺中。作为对比,标以″无干预″的曲线示出了呼吸信号最终达到无气流信号48,从而表示基本上完全阻塞。在所示例子中,在局部或完全阻塞期间,气管(T)中的气流信号的强度不足以导致所述一或多个气管内气流传感器80检测到呼吸,并且通气流A被从呼吸机(V)以基于患者先前自发呼吸率历史的流率44传输。备选地,通气流(A)能以预定的备份流率从呼吸机(V)传输。
在对图3所示经气管通气基于检测到阻塞被启动的方案的改型中,图4利用曲线图示出了在预期或预测出会出现阻塞或呼吸暂停事件时经气管通气启动。一或多个气管内气流传感器80可以检测到气管气流从正常气流信号32漂移到减弱的气流信号34。立即或在经历了一段预期的延迟之后,控制单元159可以命令呼吸机(V)与吸气同步的方式40传输通气流(A)。备选地,通气流(A)能以预定的备份流率传输。
图5利用曲线图示出了经气管通气抢先启动,以防止阻塞或呼吸暂停事件。一或多个气管内气流传感器80可以检测出气管气流从正常气流信号32漂移至减弱的气流信号34。控制单元159可以命令呼吸机V与吸气同步的方式40传输通气流(A)。备选地,通气流(A)能以预定的备份流率传输。
在图3-5中的实施方式中,先于阻塞启动经气管通气可能导致不希望有的负面影响,即由于气体排出导管时的文丘里效应而在上呼吸道中产生额外负压力。这种增大的负压力可导致呼吸道收缩。为防止或最小化这种负面效应,通气气体参数可以随时调节至适宜的压力、速度和体积。在抢先经气管通气中,如果呼吸传感器检测到发生上呼吸道闭合,通气参数可以被调节。然而,如果由于抢先经气管通气而导致局部阻塞,则图3中描述的动作机构可以起压倒作用,这样治疗就会成功。额外的实施方式被提供以避免不得不补偿不希望有的负面效应。
可选地,高频率小体积通气可被呼吸机(V)和经气管导管10、10′、10″传输,其中非常小体积的气体被以非常快速的频率传输,例如大约5-100ml、每分钟大约12-120周期,或优选大约10-20ml、每分钟大约30-60周期。以这种方式,实质上微小体积可被传输至肺(L),而不会在口咽呼吸道(OA)产生明显的负压力。
图27利用曲线图示出了经气管通气可在呼吸暂停或呼吸道阻塞期间启动,其中通气流(A)被启动,然后在呼吸恢复后关闭。在启动后通气流(A)可以循环地传输。一或多个气管内气流传感器80可以检测出气管气流从正常气流信号32漂移至减弱的气流信号34。控制单元159可以在受阻呼吸信号48期间命令呼吸机(V)以基于以往呼吸率历史的流率44传输增强气流(A)。备选地,通气增强(A)能以预定的备份流率传输。
一或多个气管内气流传感器80可以操作根据下述原理。在局部阻塞期间,气管(T)中的气体流因阻塞而减少。由于将空气移动经过局部阻塞部所需的增大的压降,气管压力信号典型地会增加。在完全阻塞期间,气管中的气体流由气管(T)和肺(L)已有的空气来回移动形成,并且由于气管(T)和肺(L)相对于外界关闭,因而气管压力信号表现为高幅值。虽然气管气流在图中被显示,但这只是示例性的,并且通过前面的解释,本发明还包括使用气管压力来控制***输入以及气管气流,或压力和气流二者。因此,在局部或完全阻塞期间,基于压力的呼吸传感器可以特别有效地检测到阻塞,这是因为在阻塞的或阻力更大的呼吸道中压力幅值增加,因而可测量到更高压降。
同时利用压力和气流传感器可能是理想的,因为信息可以彼此参照对方来互相检验,例如,减弱的气流信号加上增大的压力信号可以对应于阻塞事件。此外,前面描述的其它呼吸传感器类型以及它们响应于阻塞或呼吸暂停事件的相应信号,也包含在本发明中。应当指出,在CSA中,肺不呼吸,因此在呼吸暂停事件期间没有气流或压力信号。压力传感器或流量传感器或它们的组合可为OSA、CSA患者以及同时患有OSA和CSA的患者区分正常呼吸和呼吸暂停事件。
下面将描述治疗的动作机构。在上呼吸道局部或完全阻塞期间,在经气管导管的远侧末端部的气体传输排出点的上方或上面会有呼吸道阻力增加。因此,呼吸***不再是开式呼吸道呼吸***;其现在是封闭***,或局部开式***。因此,由呼吸机和导管传输的气体有很大的倾向进入和充胀肺,而非通过口排出。假定为正常成人和健康的肺,例如,肺具有大约50ml/cm H2O的顺应性和5cm H2O/L/秒的较低呼吸道阻力,那么,在上呼吸道阻塞之前,30-70%的离开导管的通气气体流可以进入肺,余量可以从口或鼻泄露。相反,在呼吸道阻塞后,50-100%的离开导管的通气气体流可以进入肺,取决于阻塞程度。因此,在局部或完全上呼吸道阻塞中,本发明可特别有效地为肺换气,这对于必须进行肺通气的症状来说更是如此。
应指出,因为气体流从导管传输,瞬间负压力区可以在导管上方产生,这会导致上呼吸道组织进一步收缩,因而增加阻塞。瞬间负压力应当过渡到正压力,因为由呼吸机添加了气体体积的肺和气管是封闭或几乎封闭的***。尽管如此,上呼吸道中的潜在的负压力具有不理想的负面效应。然而,这种负面效应在临床学上是可接受的,因为主要目的,即肺通气,被实现了。此外,在患者的自发呼气期间,呼吸道中的气体由于肺和胸收缩而受压,因此呼吸道压力会打开阻塞以允许呼气排出上呼吸道和口或鼻。尽管如此,为了有助于解决通气引起的上呼吸道收缩问题,呼气也可以通过本发明而得到增强,如后面的实施方式所描述。
除了各种文献中描述的治疗参数,还有一些参数如下所述:体积传输可为每呼吸机周期大约10ml至200ml,取决于患者的呼吸状况。如果完全呼吸暂停出现,体积传输增加至每周期大约200ml至500ml,速率为每分钟大约6-20周期。被传输的气体的流率在实际传输气体期间典型地为大约6-50LPM,优选大约10-20LPM。呼吸机循环操作的定时可以与患者的呼吸率同步,例如,大约6-30BPM,或者如果不同步化或如果患者呼吸暂停,循环操作可以是每分钟大约8-20周期,除非高频率小体积通气被使用,如后面所描述。在呼吸机输出端用于通气的驱动压力典型地为大约5-60psi,优选大约8-40,最优选大约10-15psi,以在正常无阻塞下在吸气期间产生理想的气管压力大约0-5cm H2O,以及在有阻塞期间高达大约20cm H2O的气管压力。
应当指出,在给出的曲线图的例子中,呼吸传感器波形仅仅是示例性的,而实际波形可采用其它特性,例如不同的I∶E比、呼吸率、随机行为、吸气和呼气弯曲的上升和下降形状、交变的幅值等。
还应指出,虽然通气流(A)常被显示为与呼吸周期同步,但由于局部阻塞或呼吸暂停事件,呼吸周期可能是不可检测的,因此通气流(A)可被以预定的流率或预期的流率简单地供应。还应理解,取决于所用的传感器,有时尽管从外界吸入的气流或排放到外界的气流非常微弱,但呼吸动作仍可以被检测到。然而,在某些情况下,取决于所采用的传感器技术,响应于呼吸动作导致的空气在气管(T)中的移动可能足以被传感器检测为吸气作用和呼气作用。事实上,在一些情况下,取决于所用的传感器,阻塞可能在吸气期间伴随着增大的负压力,并且,尽管因为阻塞导致气管T中的气流减小,但呼吸信号可能更强。因此,在本发明中,气体传输控制***163和气体传输控制***163中的算法在处理传感器信息和判断任何给定时间下是正常呼吸或发生减弱的呼吸时,考虑到了所有这些因素。
还应指出,通气气体传输在被启动后,可能逐渐加强,从而使得幅值不会突然增加,因而不会弄醒患者。
通过传输通气流(A)而在上呼吸道中实现的通气压力可以在大约1-20cm H2O的范围内,优选在传输抢先进行时为大约2-5cm H2O,在响应于检测到的阻塞事件进行传输时为大约5-10cm H2O。下呼吸道和肺中实现的通气压力可以类似于上呼吸道中通过通气气体传输所实现的压力。
如后文所述,通气可被与吸气同步、或与呼气同步、或与二者同步地传输,或者,可被以高频率、恒定流率、沿逆行方向、以及所有上述方式的可行组合传输。当与患者的吸气或呼气相态同步化时,呼吸机(V)能以每周期大约40-700ml范围的体积传输,优选大约75-200ml,传输时间为大约0.2至1.2秒,优选大约0.35-0.75秒,且导管排出速度为大约50-300m/秒,优选大约150-250m/秒。
当以高频率传输时,呼吸机(V)可以传输气体体积的频率为大约0.25周期每秒至大约4周期每秒,优选频率为大约0.5至2周期每秒,传输量为每周期大约10ml至100ml,优选每周期大约25-75ml。
当以恒定流率传输时,呼吸机V可以传输气流的流率为大约0.5LPM至10LPM,优选大约2-6LPM,而导管排出速度为大约50m/秒至250m/秒,优选大约100-200m/秒。
图6-15利用曲线图描绘了本发明所用各种经气管通气参数,包括定时、同步化、波形和幅值的各种方案。在这一系列曲线图中,t为时间轴,P为呼吸道压力信号,Q为呼吸道气流信号,IP为吸气压力,EP为呼气压力,IQ为吸气流信号,EQ为呼气流信号,VO为呼吸机输出,32为正常呼吸流量曲线,而34为当呼吸道出现局部阻塞时的呼吸流量曲线。
图6利用曲线图描绘了本发明的实施方式,其中经气管通气被启动以减轻阻塞或呼吸暂停事件,并且通气气体(A)流量/体积可以与呼吸周期的吸气同步的方式40。减弱的气流信号34被所述一或多个气管内气流传感器80检测到,然而,也可以利用冗余压力信号检测到增强的呼吸动作信号38,该冗余压力信号通过基于导管末端的传感器或位于经气管导管10中并且通过典型地连接着气体传输管路的通道连接至呼吸机(V)的压力检测管腔88而监视。
图7利用曲线图描绘了本发明的实施方式,其中通气流(A)被启动以减轻阻塞或呼吸暂停事件,其中通气气体被以连续流42的形式传输。
图8利用曲线图描绘了本发明的实施方式,其中经气管通气被启动以减轻由受阻呼吸信号48表示的阻塞或呼吸暂停事件。通气流(A)能以基于以往呼吸率历史的流率44传输呼吸机流量/体积。备选地,通气流(A)能以预定的流率传输,并且可能与患者的呼吸动作不同步。
图9利用曲线图描绘了本发明的实施方式,其中通气流(A)被启动以减轻阻塞或呼吸暂停事件。通气流(A)流量/体积可以与呼吸周期的吸气同步的方式40传输,并且通气流(A)能以可变的逐渐增强的强度例如体积、速度或压力传输,直至检测到阻塞被减轻,此时通气流(A)传输强度可以降低。
图10利用曲线图描绘了本发明的实施方式,其中通气流(A)流量/体积可以与呼吸周期的吸气同步的方式40传输,并且被抢先启动以有助于防止阻塞或呼吸暂停事件。当阻塞或呼吸暂停事件出现时,通气流(A)的流量可以在与吸气相态同步化的循环体积传输方式47与体积传输间的连续流之间交替地变化。
图11利用曲线图描绘了本发明的实施方式,其中通气流(A)被以连续流42的方式抢先启动以有助于防止阻塞或呼吸暂停事件或有助于防止淡化。当阻塞或呼吸暂停事件出现时,通气流(A)的流量可以在与吸气相态同步化的周期性体积传输方式47与体积传输间的连续流之间交替地变化。
图12利用曲线图描绘了本发明的实施方式,其中通气流(A)被以连续流42的方式抢先启动以有助于防止阻塞或呼吸暂停事件或有助于防止淡化。当阻塞或呼吸暂停事件被检测到时,利用增大的呼吸机连续气流信号43,连续流42的幅值可以如图所示地增加,然后在呼吸暂停事件被纠正后可以降低。
图13利用曲线图描绘了本发明的实施方式,其中通气流(A)被启动以减轻阻塞或呼吸暂停事件。通气流(A)可以与患者的呼气相态同步化地传输,并且,通气气体(A)体积可以沿逆行方向45传输,即背离肺且朝向口咽呼吸道。
图14a利用曲线图描绘了本发明的实施方式,其中通气流(A)被同步化而以与吸气同步的方式40朝向肺传输通气以及在呼气过程中沿逆行方向45朝向口咽呼吸道传输通气。
图14b利用曲线图描绘了本发明的实施方式,其中通气流(A)被同步化而以与吸气同步的方式40和在呼气相态中朝向肺传输通气。
图15a利用曲线图描绘了本发明的实施方式,其中通气流(A)被同步化而以与呼气同步的方式46朝向肺传输通气以及在吸气相态中沿逆行方向45朝向口咽呼吸道传输通气。
图15b利用曲线图描绘了本发明的实施方式,其中通气流(A)被同步化以便在吸气相态中和在呼气相态中沿逆行方向45朝向口咽呼吸道传输通气。
图16a描绘了本发明的另一实施方式,具有逆行通气和逆行经气管导管的。具体地讲,该实施方式描述了用于治疗OSA的经气管通气方法和设备,其中通气气体利用导管被沿逆行方向或向上朝向口咽呼吸道传输,导管具有背离肺朝向上呼吸道指向的气体排出端口。这一点在此可称作逆行通气或″逆行经气管通气″(RTV)。其它名称也可使用,例如″逆行CPAP″,″逆行PAP″,″逆行AP″,″逆行同步化通气″,″逆行喷流通气″,和/或″逆行同步化经气管喷流通气″。在RTV中,除了一些例外之处,呼吸机、气体传输管路、导管和呼吸传感器可享受在图2a-2d中描述的经气管通气方法和设备。
逆行导管100可以被构造成沿上侧方向从气管(T)朝向口咽呼吸道(OA)传输逆行气体流R。前面描述过的气体传输参数和前面描述过的气体传输定时功能也可应用于RTV。例如,RTV可被施加为连续流,与呼吸周期的吸气相态同步,与呼吸周期的呼气相态同步,以预定的备份流率,以基于先前呼吸率历史的流率,以相对高频率,以及它们的组合。此外,RTV可以恒定地、间歇地、抢先于阻塞、在阻塞发生时或在阻塞或呼吸暂停事件发生后进行。呼吸传感器能以前面描述过的实施方式实施,例如示于图2a中的。
RTV的机构动作可以是抢先的、基于预测的和/或基于反应的。
抢先型RTV:如果RTV在正常呼吸中在上呼吸道阻塞发生之前抢先实施,则RTV可在吸气周期期间被传输。传输的RTV流率是患者的吸入流率的一个比例,例如,大约5-75%,或优选大约10-25%,或大约为4-10LPM的流率。因此,患者的吸气可以压倒逆行流并且基本上充胀肺,尽管一些吸入流被逆行流抵消。然而,因为逆行流在患者的呼吸道中在口和导管之间产生逆阻力,因此口咽呼吸道被这种逆阻力强制打开,并且可以防止该区域的人体结构收缩。
基于预测的RTV:如果RTV是在局部阻塞出现是启用的,可采用相同的原理。RTV可以在口咽呼吸道产生逆阻力和轻微的正压力,因此促进该区域的人体结构打开。
基于反应的RTV:如果RTV是在基本上完全阻塞出现时启用的,则RTV可以在导管和封闭部位之间压缩封闭的呼吸道,并且可以打开封闭的人体结构并恢复用于呼吸来自外界的吸入空气的流路。
呼吸机输出端的用于RTV的驱动压力典型地为大约5-60psi,优选大约15-30psi,这会在正常状况下产生气管压力大约1-10cm H2O,并且可以在出现局部阻塞的状况下实现气管压力高达大约15cm H2O和在出现完全阻塞的状况下实现气管压力高达大约20cm H2O。RTV传输的体积、压力和循环操作速率和模式可采用前面借助图2a以及相关曲线图和描述中揭示的任何实施方式。在前面描述的RTV中,通气气体可以在吸气相态中传输;然而,气体能以前面的曲线图和描述中提到的各种选择方式被传输。传输的定时对于RTV的效率来说可能是重要的。例如,传输可在吸气周期开始时进行,以防止出现收缩,或者可略微在吸气开始之前被传输,以便先于随后的吸气周期的开始而建立促进人体结构打开所需的气流动力学。RTV可潜在地具有负面效应,即在肺中产生负压力和导致肺不张(atelectasis),这是因为在气管(T)中的气体排出端口内产生了文丘里效应。然而,通过正确地监视气管气流和压力,并且利用这个信息来改变RTV参数,可以消除对负肺压力和肺不张的担心。前面描述的双重检测实施方式也可以应用于这个实施方式。
图16b示出了图2a中的逆行导管的进一步细节。在本例中,造口导向件130被使用。然而,这仅仅是示例性的,其它结构也可以使用。逆行导管100可以包括压力检测管腔88和压力检测口86。可选地,有源气管内呼吸传感器80、传感器配线82和传感器配线管腔84可以使用。逆行导管100可以安置在造口导向件130中,以实现逆行导管100的定位和旋转定向的固定。如果造口导向件130被使用的话,通气导管颈凸缘5可被紧固至造口导向件130;或者,如果造口导向件130不被使用的话,可直接紧固至颈部。如果造口导向件130被使用,其可利用造口导向件系带135直接紧固至颈部。如果希望有文丘里效应,导管远侧末端段92可以在其排出点包括导管远侧末端节流器90,以增大气体排出时的速度。造口导向件键槽136和通气气体传输管路20可以提供。
图17a描绘了本发明的另一实施方式,其为描述于图2和16的实施方式的组合,具体地讲,从气管(T)朝向肺(L)引导的经气管通气与RTV相组合。在这种情况下,组合的逆行和正常方向通气导管120(其为带有双向嘴的导管)和呼吸机(V)可同时具有下述传输通气气体的能力:(1)通过向下气体排出端口11从气管(T)朝向肺(L)传输,(2)通过向上气体排出端口15从气管(T)朝向口咽呼吸道(OA)传输。这可以如图19a和19b所示地进行,其中组合的逆行和正常方向通气导管120具有组合的逆行和正常方向气体传输管腔125。
组合的逆行和正常方向气体传输管腔125可以在向下气体排出端口11仅有分支,从而使得气体流分离为朝向肺(A)的气流和逆行流(R)。在这种情况下,导管远侧末端部的材料可以特别是柔韧性的,例如具有大约10-40的邵氏A硬度,以压缩组合的逆行和正常方向通气导管120的末端,从而可以防损伤地***。或者,优选地,如示于图18,组合的逆行和正常方向通气导管120可以分隔为两个气体传输管腔,一个为气体传输通道121,另一个为朝向肺(L)的气体传输通道123。两个管腔121、123被显示为并排分布,然而,两个管腔121、123也可以同轴分布。
其它末端形状和管腔配置也可使用。例如在图19c中,远侧末端段被显示为向下弯曲,而非示于图18a和18b的向上弯曲,其中用于肺(L)的通气流的第一孔口11位于导管的端部,用于口咽呼吸道(OA)气流的第二孔口15靠近导管的弯曲部的中央。或者,如示于图19d,导管的远侧末端段可以弯曲大于大约210度,优选大约250-270度,其中第一孔口11靠近大约80-90度区域形成,第二孔口15靠近末端形成。因此,排出第一孔口11的气体被朝向肺(L)引导,排出第二孔口15的气体被朝向口咽呼吸道(OA)引导。
与全部其它实施方式一样,导管可具有单一的气体传输管腔,并且气体可以交替地或同时传输通过两个管腔,或者导管可以具有多重气体传输管腔,以便专用与朝向肺和口咽引导气流。通气气体传输特性、呼吸检测和气体传输定时与描述与其它实施方式中的一样。前面描述的双重呼吸检测元件的实施方式也可应用于本实施方式。
图17b与图17a相关地描绘了呼吸机的进一步细节。呼吸机(V)可以包括带两个输出端的双路控制阀170、肺指向阀的气体出口171,和逆行指向阀的气体出口172。呼吸机(V)的用于气体传输管路的双路连接器180也可以包括两个气体出口连接件:肺指向气体流连接器181和逆行指向气体流连接器182。如果单一气体传输管腔被用于肺气流(A)和逆行流(R)这二者,如示于图19a,则在呼吸机和气体传输管路之间可能只要求有一个气体出口连接件。压力监视管线162可以与患者自发呼吸传感器169连通。
可选地,两个管腔可提供在导管中,一个管腔用于朝向肺的气流,另一个管腔用于逆行流,并且呼吸机气体输出和气管压力监视可在两个管腔之间交替地进行;例如,气体传输在逆行管腔中,而气管压力检测在另一管腔中,接下来,气管压力检测在逆行管腔中,而气体传输在另一管腔中。
图20-23利用曲线图描绘了组合的肺和逆行通气的一些例子。在这一系列曲线图中,t为时间轴,Q为呼吸道气流信号,IQ为吸气流信号,EQ为呼气流信号,VO为呼吸机输出,A表示朝向肺引导的通气气体,R表示朝向口咽逆行引导的通气气体,32为正常呼吸流量曲线,而34为当呼吸道出现局部阻塞时的呼吸流量曲线。
图20利用曲线图描绘了本发明的实施方式,其中经气管通气被启动以减轻阻塞或呼吸暂停事件,其中,朝向肺(L)的通气流(A)以与患者的吸气同步的方式40传输,而逆行流(R)以与患者的呼气同步的方式46传输。
图21利用曲线图描绘了本发明的实施方式,其中经气管通气被启动以减轻阻塞或呼吸暂停事件,其中,与患者的吸气同步的方式40朝向肺(L)传输的通气流(A)和朝向口咽呼吸道(OA)传输的逆行流45二者都与患者的吸气周期同步化。
图22利用曲线图描绘了当经气管通气被启动以减轻阻塞或呼吸暂停事件时的本发明的实施方式,其中,朝向肺(L)的通气流(A)与患者的吸气同步的方式40传输,而朝向口咽呼吸道(OA)的逆行流(R)被以逆行高频率体积传输的方式49传输。
图23利用曲线图描绘了当经气管通气被启动以减轻潜在的阻塞或呼吸暂停事件时的本发明的实施方式,其中,朝向肺(L)的通气流(A)在无阻呼吸期间以与患者的吸气同步的方式40传输,并且,在减弱的气流信号34期间逆行斜坡连续增加的气流传输50被朝向口咽呼吸道(OA)引导。
需要再次指出,在这些肺通气和逆行通气被组合的实施方式中,可以应用全部前面描述的用于气体传输的可行方案。例如,逆行流可以是连续流,而肺通气可可在呼吸暂停期间被间歇地传输。或者,例如,逆行气体传输可以提供为喷流,而肺通气可以提供为非喷流,反之亦然。一般来说,前面在图2和16以及相关的曲线图中描述过的气体传输参数和气体传输定时功能以及所述设备特性都可应用于本组合实施方式。
图24a和24b描述了本发明的另一实施方式,其中经口腔通气方法和设备被用于治疗睡眠呼吸暂停。在图2中描述的呼吸机(V)、经气管导管10、呼吸管路特性、气体传输和定时特性可以应用于本实施方式。
经口腔导管220可以包括口内呼吸传感器232,以及位于牙齿的舌侧的舌凸缘222。可选的元件可以包括位于牙齿的颊侧的颊凸缘224,和外部口呼吸传感器230。此外,外部呼吸动作传感器可以与本实施方式组合。因此,在局部或完全阻塞期间,口内或口外呼吸传感器信号的幅值减小,而呼吸动作传感器信号不明显减小。外部呼吸动作传感器可以是胸传感器测量胸部的尺寸偏移,或另一类型的神经肌肉学传感器,或食道传感器或另一类型的呼吸道内传感器或植入式传感器。在口腔内侧,经口腔导管220可以定形为延伸经过口的顶面,或位于舌头的顶表面上,和/或沿着牙齿的舌侧/中间侧或牙齿的颊侧/横向侧,或上述方式的组合。经口腔导管220可以***口腔到达大约硬腭远端的深度。可选地,经口腔导管220可以***口咽腔到达软腭起始点与小舌之间的深度。该深度足以引导气体流阻塞部位并且防止或减轻阻塞部的收缩。经口腔导管220可选地可以借助于非常小且无阻碍的口腔器具(未示出)紧固就位于口腔中。在口的外侧,经口腔导管220可以传统方式定位在使用者的头部或面部,从而使得其同CPAP相比是无阻碍的,并且可选地利用通气管路颈部系带225紧固就位。
图25a和25b描述了本发明的另一实施方式,其中经鼻通气方法和设备被用于治疗睡眠呼吸暂停。在图2中描述的呼吸机(V)、经气管导管10和呼吸管路特性、气体传输和定时特性可以应用于本实施方式。
经鼻导管200可以包括鼻内呼吸传感器236。可选的元件可以包括靠近鼻孔隔膜的凸缘235,并且可选地还包括外部鼻呼吸传感器234。此外,外部呼吸动作传感器可与本实施方式组合。因此,在局部或完全阻塞期间,鼻内或鼻外呼吸传感器信号的幅值会减小,而呼吸动作传感器信号不会明显减小。外部呼吸动作传感器可以是尺寸偏移胸部的胸传感器测量,或另一类型的神经肌肉学传感器,或食道传感器或另一类型的呼吸道传感器内或植入式传感器。
在鼻腔内侧,经鼻导管200可以沿着鼻腔的顶面安置,或沿着鼻腔的底部安置,安置在中线处或沿着侧面,或以上述方式的组合。经鼻导管200还可以是半植入式的,以使得其被附连于或是局部或整体植入鼻腔内侧组织中,优选沿着腭顶部。在任一上述情况下,经鼻导管200的***深度可以是大约从腭的中点到达腭的端部,或延伸超出腭深度大约1cm。该***深度适合于引导通气气体至口咽呼吸道(OA)。可选地,经鼻导管200可以在靠近气体排出端口的点具有加大的直径,以增大通过鼻孔的气流的阻力。优选地,加大直径部分是围绕经鼻导管200靠近鼻的部位的直径的凸缘或翻边,位于鼻内侧或靠近鼻孔。该特征还可以是凸缘或罩,其定位在鼻孔外侧,以便将导管紧固就位兵密封鼻孔,从而使得通气气体不会从鼻泄露。可选地,这个特征提供了局部或不完全密封,以使得在患者不排气或不能通过口排气的情况下仍存在向鼻外的自然呼气路径。
在鼻外侧,经鼻导管200能以传统方式定位在使用者的头部或面部,从而使得起同CPAP相比始无阻碍的,并且可选地利用通气管路颈部系带225紧固就位。导管构造可以具有描述于图24a和24b中的类似特性。
用于图25a和25b中的经鼻通气实施方式的通气参数可以类似于前面借助图2以及相关曲线图和描述中揭示的实施方式中的参数,包括定时、同步化、体积、压力、气体成分、幅值和波形参数。
应指出,在这些曲线图中,呼吸机输出波形典型地显示为方形,然而,其它波形也可以用于本发明,例如正弦波形,加速度波形,减速度波形,以及它们的组合。
图26示出了本发明的另一实施方式,其中外部呼吸传感器300被与描述于图2A、16A和17A的实施方式结合使用。描述于图26的通气传输措施是经气管通气,然而经口腔和经鼻通气也可应用于本实施方式。在所示例子中,外部气流传感器300为气流传感器,其定位在鼻下面并且利用外部气流传感器紧固带或头部系带302或束带被紧固就位。外部气流传感器300可以通过外部气流传感器无线传送信号304传送信息至呼吸机控制***。外部气流传感器无线传送信号304可以被通气气流传感器信号接收器308接收,或通过外部气流传感器信号线306接收。来自外部气流传感器300的信息可以在呼吸暂停、局部阻塞或先前实施方式中的其它组合状态期间为呼吸机(V)提供信号,以便根据希望提供通气。本实施方式在一些状况下可能是有利的,例如轻呼吸或在慢性支气管炎的状况下当呼吸道分泌物过量时,此时气管内气流传感器80的可靠性可能低于外部传感器。此外,包含在本实施方式中的是双重传感器措施,其中经气管导管10可以包括呼吸传感器,特别适用于测量呼吸动作。***可以额外包括外部呼吸传感器,特别适用于测量呼吸气流,以向整个***提供冗余度,并且能够区分呼吸动作和实际呼吸。外部气流传感器可以是热传感器,压电传感器,超声传感器,呼吸速度传感器,热线式风速计,以及其它类型的检测元件。虽然外部传感器被显示为鼻或口气流传感器,但这仅仅是示例性的,外部传感器可以是任何类型的能测量实际呼吸的传感器,例如气体成分传感器,pH传感器,和/或血氧传感器。
除了图26中的例子,外部呼吸传感器还可以是呼吸动作传感器,而非实际呼吸传感器。在这种情况下,呼吸道内传感器是实际呼吸传感器,例如流量传感器或气体成分传感器。外部呼吸动作传感器的例子包括前面描述过的那些。
如果患者还遭受呼吸功能不全的病痛,本发明的另一优点可以实现。在这种情况下,通气设备可以被构造成双模式的:在日间患者可以利用实质上相同的通气设备和导管接受经气管增强通气,或经口腔或经鼻增强通气。然后在夜间,所述设备可以用于治疗OSA,或用于治疗OSA和呼吸功能不全这二者。在这种情况下,呼吸机的治疗输出参数很可能不同于OSA和呼吸功能不全的情况。因此,呼吸机(V)可以具有方便的措施使得使用者从日间模式切换到OSA模式。例如,开关可被用于启动RTV。例如,经气管导管可以是双重气体传输管腔,即肺通气管腔和逆行管腔。在日间,逆行管腔关闭,而在睡眠之前,呼吸机上的逆行管腔和气体传输控制部被接通。呼吸功能不全者以第一模式日间使用可以采用第一组参数,包括氧气浓度、体积和压力,以及定时输出,和气流方向(向下或向上)。在睡眠中以第二模式夜间使用可以采用第二组参数,包括氧气浓度、体积和压力,以及定时输出,和气流方向(向下或向上)。这种双模式实施例仅仅是示例性的,并且前面描述过的气体传输管腔、同步化、逆行引导气流和肺引导气流的全部可行组合可以用于本发明的这个方面。从日间模式切换到OSA模式还可以由呼吸机中的可编程内部时钟自动控制,以及由外部输入例如从呼吸传感器输入来控制。
作为本发明的一部分,传输至肺的通气气体或沿逆行方向传输的气体可选地可以利用喷流气体传输动力学器件传输。这些动力学器件可以夹带气流以放大来自通气气体本身的作用。排出速度可为大约25-300m/s,优选大约100-200m/秒。如前面所描述,气体传输可是间歇传输的具有治疗作用的离散体积,或者能以高频率产生具有治疗作用的动态压力,或在呼吸道组织和人体结构上产生抗阻塞或抗收缩作用,例如以低负压力和正压力振荡变化的方式实现高度微小体积传输。虽然在大多数情况下希望调节通气参数来维持或恢复上呼吸道敞开,但在一些情况下可能希望利用导管气体排出时产生的文丘里效应关闭上呼吸道,以便于利用呼吸机气体流充胀肺。非喷流传输也包含在本发明中,例如排出速度低于大约50m/秒。
由呼吸机传输的气体成分典型地为常规空气,因为患者可能不需要额外氧气来维持适宜的血液气体级别;然而,气体可利用从氧气源例如液态氧气源,压缩氧气气体源或氧气浓缩器释放的氧气而具有更高浓度的氧气。优选地,响应于预测或检测呼吸暂停事件或阻塞,利用由呼吸机控制的控制***,使得更多氧气释放到气体传输管路种,从而氧气浓度可以增加。因此,***可以在不需要时储存氧气,并且需要时使用氧气。理想地,***控制装置被构造成当没有发生呼吸暂停或阻塞时传输大约21-35%的氧气,当呼吸暂停或阻塞发生时传输大约35-75%的氧气。
在考察本发明是,应当指出,本发明解决了两个方面治疗OSA的问题。本发明既提供了从呼吸机至肺的通气,还提供了传输气体至阻塞部,以防止、最小化或逆转阻塞,从而恢复从外界空气的自发呼吸。这一点同传统CPAP相比具有额外优点,即在CPAP中,CPAP通气气体同时用作打开阻塞部的气体和为肺通气的气体。在本发明中,经气管通气可以用于增强肺的通气,并且还可以用于打开阻塞部从而使得患者可自发呼吸外界空气。这可避免需要使用CPAP中所需的加热型加湿器,在CPAP中这种加湿器被需要,以防止上呼吸道因为CPAP传输的过量气体导致的干燥。此外,本发明要求的气体传输量可以远低于CPAP,因此整个治疗可以更安静,设备可以包装成更小的体积,这更适合于旅行。此外,患者界面,包括气体传输管路和导管,可以比CPAP治疗中使用的对应部件更小、更轻质,使得利用本发明进行治疗对于使用者而言侵袭性更小、更易忍受。
虽然本发明在描述时大部分的例子支队的是治疗阻塞性睡眠呼吸暂停(OSA),单通过适宜的修改,本发明可以应用于之列中枢性睡眠呼吸暂停(CSA),组合的OSA和CSA,和其它呼吸道病变或呼吸疾病。此外,本发明还可以应用于其它通气治疗或介入式治疗,举几个例子,麻醉传输,撤除机械通气,紧急通气,氧气治疗,治疗性气体传输,或药物传输。此外,包含在本发明中的经气管导管除了可以***造口导向件外,还可以***气管造口管,或直接***气管。此外,药物传输可与治疗相组合,即包括与呼吸机控制***和气体传输管路连通的药物传输模块。例如当呼吸暂停事件被预测或检测出来时,有助于恢复组织刚性以防止组织收缩的药物可利用通气气体被传输至口咽呼吸道。
尽管前面的描述面向本发明的优选实施方式,但应指出,本领域技术人员容易做出其它修改和改造,而不脱离本发明的精神和范围。另外,结合本发明的一个实施方式描述的特征可以与其它实施方式组合使用,即使前面没有明确提出。本发明还能以其它特定形式实现,而不脱离其精神和基本特性。所描述的实施方式被认为在全部意义上都是解释性的,而非限制性的。
Claims (18)
1.一种用于治疗睡眠呼吸暂停的通气设备,所述设备包括:
用于传输通气气体的呼吸机;
用于呼吸机的控制***;
用于***气管中的经气管通气导管;
所述经气管通气导管的远侧末端部;
一或多个第一传感器,来自所述一或多个第一传感器的信号测量实际的呼吸;
一或多个第二传感器,来自所述一或多个第二传感器的信号测量呼吸动作;
将呼吸机连接至经气管通气导管的通气气体传输管路;
其中,远侧末端部沿着选自下面一组的方向传输通气气体:在呼吸周期的呼气相态期间从经气管通气导管向上朝向上呼吸道,在呼吸周期的吸气相态期间从经气管通气导管向下朝向肺,以及它们的组合;并且
当通过所述一或多个第一传感器测量到异常低的信号同时所述一或多个第二传感器测量到异常高的信号而检测到呼吸暂停时,所述控制***与呼吸周期同步地启动呼吸机以传递增大体积的通气气体。
2.如权利要求1所述的设备,其中,控制***操作呼吸机以使得通气气体以选自下面一组的方式传输:在通过所述一或多个传感器检测的呼吸周期的吸气相态中,在通过所述一或多个传感器检测的呼吸周期的呼气相态中,在通过所述一或多个传感器检测的呼吸周期的吸气相态和呼气相态二者中,在通过所述一或多个传感器检测的呼吸周期中连续地,在通过所述一或多个传感器检测的呼吸周期中循环地,流量幅值随时间增加,控制***响应于来自所述一或多个传感器的测量值调节流率,以及它们的组合。
3.如权利要求1所述的设备,其中,通气气体被以低流率和高压力传输。
4.如权利要求1所述的设备,其中,通气气体被以高频率传输。
5.如权利要求1所述的设备,其中,通气气体被以喷流的形式传输。
6.如权利要求1所述的设备,其中,通气气体以选自下面一组的方式传输:抢先进行以防止或最小化阻塞或呼吸暂停事件,在阻塞或呼吸暂停事件发展的过程中进行,对阻塞或呼吸暂停事件作出反应而进行,以及它们的组合。
7.如权利要求1所述的设备,其中,所述一或多个第一传感器和所述一或多个第二传感器中的一或多个被连接至经气管通气导管。
8.如权利要求1所述的设备,其中,所述一或多个第一传感器和所述一或多个第二传感器中的一或多个位于气管外部。
9.如权利要求1所述的设备,其中,所述一或多个第一传感器是气管中的一或多个气流传感器,并且所述一或多个第二传感器是气管中的压力传感器。
10.如权利要求9所述的设备,其中,来自所述一或多个气流传感器的信号和来自所述一或多个压力传感器的信号被控制***组合以启动呼吸机。
11.如权利要求1所述的设备,其中,所述一或多个第一传感器测量实际呼吸空气动作并且所述一或多个第二传感器测量直接或间接呼吸肌肉作用,并且,控制***处理来自第一传感器和第二传感器的信号以区分选自下面一组的状况:轻呼吸,阻塞,减弱呼吸动力,以及它们的组合。
12.如权利要求1所述的设备,进一步包括加湿器。
13.如权利要求1所述的设备,其中,通气导管穿过造口导向件。
14.如权利要求1所述的设备,其中,远侧末端部在气管中朝向上呼吸道向上弯曲。
15.如权利要求1所述的设备,其中,经气管通气导管包括具有选自下面一组的功能的多重管腔:朝向肺传输气体,朝向上呼吸道并且背离肺传输气体,监视气管压力,容置呼吸传感器配线,或它们的组合。
16.如权利要求1所述的设备,其中,远侧末端部包括两个通气气体排出端口,其中,第一气体排出端口朝向肺引导通气气体,第二气体排出端口背离肺朝向上呼吸道向上引导气体。
17.如权利要求1所述的设备,其中,远侧末端部包括双分支,其中,双分支的第一部分朝向肺向下弯曲或弯折,双分支的第二部分背离肺朝向上呼吸道向上弯曲或弯折。
18.如权利要求1所述的设备,其中,通气设备在日间利用第一组参数以第一模式操作,用于呼吸功能不全的状况;并且在夜间在睡眠过程中利用第二组参数以第二模式操作。
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WO2009042973A1 (en) | 2009-04-02 |
AU2008304203B2 (en) | 2013-05-30 |
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AU2008304203A2 (en) | 2010-05-27 |
CA2700869C (en) | 2018-10-30 |
CA2700869A1 (en) | 2009-04-02 |
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CN101888868A (zh) | 2010-11-17 |
EP2203206A1 (en) | 2010-07-07 |
US8925545B2 (en) | 2015-01-06 |
AU2008304203B9 (en) | 2014-02-27 |
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