CN102762250B - 用于包括具有夹带端口和/或压力特征的非密封通气界面的无创通气的方法、系统和装置 - Google Patents
用于包括具有夹带端口和/或压力特征的非密封通气界面的无创通气的方法、系统和装置 Download PDFInfo
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Abstract
本发明提出了的系统和方法可以包括气体源、气体传输回路和允许经过鼻界面呼吸环境空气的鼻界面。穿过鼻界面的气体流动路径可以具有远端气体流动路径开孔。喷嘴可以与远端气体流动路径开孔相距一定距离处的鼻界面的近端相连。至少一部分夹带端口可以在喷嘴与远端气流开孔之间。喷嘴可以将气体传输到鼻界面内以在夹带端口处的气体流动路径中生成负压区域。鼻界面和喷嘴可以在夹带端口与远端气体流动路径开孔之间生成正压区域。来自气体传输源的气体和通过夹带端口夹带的空气可以增大气道压力或肺压或提供通气支持。
Description
相关申请的交叉引用
本申请要求2009年9月3日提交的美国临时专利申请No.61/239,728、2009年10月28日提交的美国临时专利申请No.61/255,760、2010年1月12日提交的美国临时专利申请No.61/294,363和2010年2月19日提交的美国临时专利申请No.61/306,370的优先权;其内容整体通过引用包含在此。本申请宁还要求2010年4月2日提交的美国非临时专利申请No.12/753,846、2010年4月2日提交的PCT专利申请No.PCT/US2010/029871、2010年4月2日提交的美国非临时专利申请No.12/753,851、2010年4月2日提交的PCT专利申请No.PCT/US2010/029873、2010年4月2日提交的美国非临时专利申请No.12/753,853、2010年4月2日提交的美国非临时专利申请No.12/753,854、2010年4月2日提交的PCT专利申请No.PCT/US2010/029874、2010年4月2日提交的美国非临时专利申请No.12/753,856和2010年4月2日提交的PCT专利申请No.PCT/US2010/029875的优先权;其内容整体通过引用包含在此。该申请通过引用包含2010年9月3日提交的名称为“METHODS,SYSTEMS AND DEVICES FOR NON-INVASIVE VENTILATION INCLUDING A NON-SEALING VENTILATION INTERFACE WITH AFREE SPACE NOZZLE FEATURE”的美国非临时专利申请No.______和2010年9月3日提交的名称为“METHODS,SYSTEMS AND DEVICES FOR NONINVAS IVE VENTILATION INCLUDING ANON-SEALING VENTILATION INTERFACE WITH A FREE SPACE NOZZLE FEATURE”的PCT专利申请No.______。
技术领域
本发明涉及用于遭受呼吸和通气失调例如呼吸机能不全和睡眠呼吸暂停的人的通气疗法领域。更具体地,本发明涉及利用使用非密封无创鼻通气病人界面的方法和装置提供开放式气道通气。
背景技术
对于传输机械通气支持或正气道压力和不会妨碍病人的最低程度地突出的鼻罩和通气系统存在需要。存在一系列需要将会受益于这种面罩和系统的通气疗法的临床综合症,例如呼吸机能不全、气道或睡眠失调、充血性心力衰竭、神经肌肉病,和一系列将会受益的情况,例如慢性、急性、紧急、重大伤亡和流行情况。
利用不会妨碍病人的装置有利于氧气疗法。然而,与通气疗法相比,氧气疗法用于远不那么严重的形式的临床综合症。例如,为了通过夹带空气到面罩中传输空气和氧气的混合物,已经开发了一些鼻罩氧气疗法系统,然而这些不是经过深思熟虑的通气疗法或呼吸支持,因为它们并不机械地有助于呼吸功。近年来,已经应用了被称为高流量氧气疗法(HFOT)的氧气疗法的变体。在这种情形下,氧气流速增大超过标准长期氧气疗法(LTOT),例如高15LPM。因为高流速,氧气必须被加湿以防止使病人的气道干燥。它已经报告,HFOT可以略微降低自主呼吸期间病人的绝对胸膜压力,因此对呼吸功具有轻微的影响。因为它们消耗的大量的氧气,使它们成为非活动系统并且妨碍病人,因此这些系统是无效的。
存在向病人提供机械通气(MV)并且机械地有助于呼吸功的呼吸支持和通气疗法。MV疗法通过使用翻边的或未折边的气管导管或密封面或鼻罩或密封鼻套管插入病人来连接至病人。虽然有助于支持呼吸功,但是用于MV的病人界面对于使用者是突出的和/或创伤性的,并且MV不便于移动性或日常生活活动,因此妨碍了病人并且对于许多潜在的使用者而言是一个缺点。存在使用脸或鼻罩而不需要插管来使病人通气的无创通气(NIV),它在许多情况下是一个优点。然而,病人不能使用他们的上气道,因为界面会在鼻子和/或嘴上形成外部密封,并且此外系统不是活动的,其组合不能够进行日常生活活动。
为了治疗阻塞性睡眠呼吸暂停(OSA),黄金标准通气疗法是持续性正气道压力(CPAP)或双水平气道正压(BiPAP),它是NIV的变体,其中病人通过面罩中的排气口部分地呼气并且回到大的气体传输管件中,而不是如MV中那样通过呼气回路。由通气机通过密封在鼻子或脸上的鼻罩或面罩向病人施加的持续性正压可以防止上气道阻塞。虽然有效,但是该疗法具有差的病人顺应性,因为病人界面对于病人是突出的,并且因为病人通过面罩和气体传输回路不自然地呼吸。
总之,现有的疗法和现有技术具有下列缺点:它们不以不会妨碍病人的方式提供呼吸支持或气道支持并且(1)是无创的,并且非突出的,这样它就允许移动性和日常生活活动,(2)允许从周围环境正常地呼吸的感觉,并且(3)提供在很容易便携的系统或可以由病人很容易地承受或佩戴的系统中。
发明内容
本发明可以使用无创开放式气道通气(NIOV)和具有不会完全地覆盖或密封病人的嘴或鼻子的开孔的文丘里配置的非密封鼻罩界面向病人提供通气。无创开放气道非密封罩优选地配设有文丘里配置以在罩内部生成从负压到正压的变化。
本发明的实施例可以包括一种用于提供通气支持的系统,该系统包括:气体源;气体传输回路;鼻界面,允许病人通过鼻界面呼吸环境空气;穿过鼻界面的气体流动路径,其中该气体流动路径包括远端气体流动路径开孔;在与远端气体流动路径开孔相距一定距离处与鼻界面的近端相连的喷嘴;和与鼻界面相连的夹带端口,其中至少一部分夹带端口在喷嘴与远端气流开孔之间,其中喷嘴与气体传输回路和气体源流体连通,其中喷嘴将气体传输到鼻界面内以在夹带端口处的气体流动路径中生成负压区域,其中鼻界面和喷嘴可以在夹带端口与远端气体流动路径之间生成正压区域,并且其中来自气体源的气体和通过夹带端口夹带的空气的组合提供通气支持。
本发明的实施例可以包括一种用于增大气道压力的方法,该方法包括:提供鼻界面,允许病人通过鼻界面呼吸环境空气,其中鼻界面包括气体流动路径,其中该气体流动路径包括远端气体流动路径开孔和近端气体流动路径开孔;在与鼻子相距一定距离处提供与鼻界面的近端相连的喷嘴;提供基本上在喷嘴与鼻界面的远端之间与鼻界面相连的夹带端口,其中至少一部分夹带端口在喷嘴与远端气流开孔之间;并且使喷嘴与气体传输回路和气体源流体连通,其中喷嘴能够将气体传输到鼻界面内以在夹带端口处的气体流动路径中生成负压区域,其中鼻界面和喷嘴可以在夹带端口与鼻界面的远端之间生成正压区域,并且其中来自气体源的气体和通过夹带端口夹带的空气的组合增大气道压力。
本发明的系统和方法还可以包括鼻界面,该鼻界面包括声音降低特征。声音降低特征可以是使喷嘴与歧管气体流动路径中心线轴倾斜大约1-30度的角度。声音降低特征可以是离开歧管气体流动路径中心线5-25%放置的偏心的喷嘴。声音降低特征可以包括与夹带端口分离的辅助气流出口。由鼻界面生成的声音在1米处可以<50分贝。气体流动路径可以包括基本上横向于中线部分的第一部分和在第一部分远端的基本上为下到上部分的第二部分,以及在这两个部分之间的蛙鸣去,且正压区域基本上邻近该弯曲生成。压力检测端口可以终止于气体流动路径中的正压区域内。气体流动路径可以包括左气体流动路径和单独的右气体流动路径。左气体流动路径和右气体流动路径可以与互连通道气动地互连。可以包括歧管,其中该歧管在中线的每侧上弯曲有侧-后-下弯曲以将歧管置于对使用者最舒服处。可以包括歧管,其中该歧管包括至少一个弯曲接头,并且该至少一个弯曲接头位于歧管的中线上。歧管可以由柔性材料构成。可以包括歧管,并且其中该歧管由成形为使用者的脸形的韧性材料构成。可以包括歧管,和歧管的中心处的间隔调节。一个或多个鼻垫可以连接至远端气流开孔,该一个或多个鼻垫包括在枕?上的扣环和围绕远端气流开孔的配合环,枕包含硬质材料。一个或多个鼻垫连接至远端气流开孔,该一个或多个鼻垫包括到鼻界面的旋转连接。气体流动路径的横截面面积从夹带端口到远端气流开孔并不减小。气体流动路径的横截面面积从夹带端口到远端气流开孔是一致的。气体流动路径的横截面面积从夹带端口到远端气流开孔可以增大。来自气体源的气体的传输可以与吸气阶段同步。来自气体源的气体的传输时间使用呼吸速率调节以基于病人的自主呼吸速率在不同的时间和压力幅度下传输设定容积。来自气体传输源的气体可以由可佩戴的通气机控制。通气支持可以包括减少呼吸功以治疗呼吸机能不全。通气支持可以包括提高气道压力以治疗睡眠呼吸暂停。喷嘴和气体传输管件可以仅仅连接至鼻界面的一侧。气体流动路径可能不包括陡角。陡角可以基本上是90度。相对于来自气体源的气体和通过夹带端口夹带的空气的组合中的来自气体源的气体,病人可以接收大约20-200%的夹带的空气。喷嘴可以包括尖端,其中至少一部分夹带端口在喷嘴的尖端与远端气流开孔之间。喷嘴的尖端可以位于夹带端口的中点处。喷嘴的尖端可以在距中心线大约5-60毫米处。夹带端口可以完全地位于喷嘴远端。夹带端口可以具有大约0.035-0.095平方英寸的平均横截面面积。负压区域可以在气体流动路径内部。负压区域可以从夹带端口延伸到邻近鼻界面的远端的位置。负压可以小于环境压力。负压可以为大约-5至-40cm H2O。正压区域可以在气体流动路径内部。正压区域可以在气体流动路径内部从夹带端口远端的位置延伸至鼻界面的远端。正压可以大于环境压力。正压可以为大约0.01至0.50psi。来自气体源的气体和通过夹带端口夹带的空气的组合可以使上气道压力增加大约2-35cwp。来自气体源的气体和通过夹带端口夹带的空气的组合可以作为层流离开鼻界面。鼻界面可以具有大约-0.75-2.0英寸的喉管长度。气体传输回路可以具有小于大约4毫米的内径。至少一个传感器可以测量呼吸阶段。可以提供通气机,其中该通气机包括控制单元,并且其中控制单元基于来自至少一个传感器的信息调节通气机的输出以匹配病人的通气需要。
本发明的实施例可以包括一种用于增大气道压力的系统,该系统包括:气体源;气体传输回路;鼻界面,允许病人通过鼻界面呼吸环境空气;穿过鼻界面的气体流动路径,其中该气体流动路径包括远端气体流动路径开孔;在与远端气体流动路径开孔相距一定距离处与鼻界面的近端相连的喷嘴;并且其中喷嘴与气体传输回路和气体源流体连通,其中喷嘴将气体传输到鼻界面内以在鼻界面的近端附近的气体流动路径中生成负压区域,其中鼻界面和喷嘴在气体流动路径内部负压区域的远端生成正压区域,并且其中来自气体源的气体和在气体流动路径内夹带的空气的组合增大气道压力。
本发明的系统和方法还可以包括与鼻界面相连的夹带端口,其中至少一部分夹带端口在喷嘴与远端气流开孔之间。负压区域可以从夹带端口延伸到邻近鼻界面的远端的位置。负压可以小于环境压力。负压可以为大约-10至-50cmH2O。正压可以大于环境压力。正压可以为大约2-30cmH2O。
本发明的实施例可以包括一种用于向病人传输治疗级别的气体的方法,其中气体的量增大口咽气道的压力至能够减少阻塞性睡眠呼吸暂停气道阻塞的压力级别,该方法包括:将鼻界面连接到病人上,其中该界面不会妨碍病人直接地通过界面呼吸环境空气;将喷嘴置于鼻子侧向的界面的近端处的鼻界面中,并且将夹带端口置于鼻界面中在喷嘴与鼻界面的远端之间;将通气机连接至气体传输回路并且将气体传输回路连接至喷嘴并且从通气机向鼻界面传输气体;在与界面远端一定距离处在孔的位置上以在界面内部生成负压的速度从喷嘴向鼻界面内传输气体;和在鼻界面中的负压区域与界面远端之间生成正压区域的界面,其中基本上病人的所有呼出气体流经环境空气夹带孔并且实际上不会流经气体传输回路,并且其中气体的治疗级别需要(a)气体来自通气机和(b)由通气气体传输生成的在鼻界面中的速度通过孔夹带环境空气。
本发明的系统和方法也可以包括在界面的夹带区域远端的界面中的正压区域中使用置于夹带孔与病人的鼻子之间的开放式气道压力检测端口监视病人的呼吸压力。可以在鼻界面中提供声音降低特征,且声音降低特征从下列组中选取:(i)与在喷嘴与鼻子之间的气体流动路径的轴线偏移轴线地对准喷嘴,(ii)与在喷嘴与鼻子之间的气体流动路径的中心线轴偏移喷嘴,(iii)除了用于气体的脱离期间的界面中的孔之外包括辅助端口,(iv)上述的组合。通气机可以设置有断开-开启模式,包括第一通电/气体传输断开状态,和第二通电/气体传输开启状态、在开启状态之前并且提供零气体传输的断开状态,和提供治疗气体传输的开启状态,并且在气体传输断开和开启状态之间提供延迟,其中气体传输断开状态最初是在通气机通电并且界面连接至病人之后启动,并且其中在气体传输断开状态期间,病人通过界面自由地呼吸环境空气,并且在延迟之后,启动气体传输开启状态,其中启动激活是从下列的组中选取的:(i)预定时间,(ii)呼吸速率的减小,(iii)呼吸压力信号的减小,(iv)减呼吸压力级别的减小,(V)上述的组合。可以提供防止响应语音的气体的无意的传输至病人的语音检测过滤算法。多个波幅的气体可以传输至病人,其中不同的波幅与病人的自主呼吸模式同步,其中第一波幅是与吸气阶段同步传输的气体的治疗等级,并且第二波幅与呼气阶段同步传输,其中从呼气阶段波幅向吸气阶段波幅的过渡始于呼气阶段中吸气阶段开始之前。大于1/3的传输至病人的气体可以来自通气机,并且大于1/5的传输至病人的气体可以来自通过夹带孔夹带的环境空气。来自通气机的气体传输压力输出可以大于10psi,其中来自通气机的流速输出可以小于25lpm,其中气体传输回路气体传输通道内径可以小于3毫米,并且其中离开喷嘴的气体速度可以大于100米/秒。可以使用与通气机气体传输回路平行的传输电路向病人传输潮湿气体并且其中潮湿气体加至负压夹带区域处的界面。单独的左和右呼吸传感器可以用于分别地测量、监视、处理和跟踪左鼻孔和右鼻孔呼吸压力。在通过传输气体进入鼻子时,气体可以是分层的,这样它就在大于100m/s的最高速度下离开喷嘴进入界面,并且与在小于50m/sec的低速下的夹带的空气进入病人的鼻子。
本发明的实施例可以包括一种用于治疗睡眠呼吸暂停的通气机,该通气机包括:当能够传输治疗级别时,气体传输输出包括>15psi的输出压力和<25lpm的输出流速;可连接至气体传输回路的小于3毫米内径的气体传输输出端口;用于并未与通气机气体流线串联的气道压力检测信号的输入;控制系统,包括:用于气道压力检测信号的输入;设计成防止语音被分类为呼吸的语音过滤模式;和基于气道压力检测信号传输所需量的气流以生成邻近病人的气道的气道压力的期望值的算法。
本发明的系统和方法也可以包括包括循环模式的通气机,该循环模式包括向病人传输多个波幅的气体,其中不同的波幅与病人的自主呼吸模式同步,其中第一波幅是与吸气阶段同步传输的气体的治疗等级,并且第二波幅与呼气阶段同步传输,其中从呼气阶段波幅向吸气阶段波幅的过渡始于呼气阶段中吸气阶段开始之前。该通气机还包括开关算法,该开关算法包括通电和气流断开状态和通电和气流开启状态,并且包括气流断开和开启状态之间的延迟,其中气流断开最初是在通气机通电并且界面连接至病人之后启动的,并且其中在气体传输断开期间,当病人通过界面自由地呼吸环境空气时,控制系统从病人接收呼吸压力信号,并且在延迟之后,气流开启状态启动,其中启动激活是从下面的组中选取的:(i)预定时间,(ii)呼吸速率的减小,(iii)呼吸压力信号的减小,(iv)减呼吸压力级别的减小,(V)上述的组合。通气机控制系统可以适于接收对应于左和右鼻孔的专用输入的多个呼吸压力输入,并且另外其中该控制系统包括适于基于两个信号的比较调节气体输出参数的算法。
本发明的实施例可以包括一种用于治疗睡眠呼吸暂停的鼻界面,包括具有远端和近端和从远端延伸至近端的气体流动路径的管状主体,其中该管状主体包括:设计成与鼻孔气道紧密接触的远端;设计成从鼻孔远端向近端侧向地弯曲的管状主体;在管状主体中位于近端与远端之间的环境空气夹带孔,适于允许直接地通过孔自主呼吸环境空气而不会妨碍使用者的呼吸;喷嘴端口,邻近管状主体的近端处的孔放置并且适于将空气导引到气体流动路径中并且从夹带孔夹带空气;和压力检测端口,其中气体从喷嘴和通过该孔夹带的空气的组合传输至病人气道,并且其中基本上离开病人的所有的气体从该孔中离开。
本发明的系统和方法也可以包括,气体流动路径包括喷嘴与远端之间的长度,允许离开喷嘴的速度型廓与气体流动路径的壁结合,并且在邻近远端并且鼻子外部的位置处形成正压。气体流动路径的最小横截面可以大于或等于夹带孔的横截面面积。夹带孔可以置于管状主体中管状主体的前侧以从脸的前面将气流夹带到孔中,并且导引呼出气体远离脸流出孔。管状主体可以包括从下组中选取的声音降低特征:在远端附近的辅助端口、从管状主体的中心线轴偏心的喷嘴位置、导引气体进入管状主体的壁中的喷嘴角度。管状主体可以包括小于0.40立方英寸的内部容积。管状主体在60lpm下可以包括小于4cmH2O压力的气流阻力。压力检测端口可以置于管状主体的正压区域中。可以设置左和右管状主体,其中每个管状主体均包括一个压力检测端口。夹带压力检测端口可以位于夹带孔附近,并且压力检测端口可以位于远端附近。
本发明的实施例可以包括一种用于向病人传输治疗级别的气体的方法,其中气体的传输量增大口咽气道的压力至能够减少阻塞性睡眠呼吸暂停气道阻塞的压力级别,该方法包括:提供鼻界面,该鼻界面不会阻止病人通过鼻界面直接地呼吸环境空气,其中鼻界面包括:在基本上横向于鼻子在鼻界面的近端处的鼻界面内的喷嘴;和基本上在喷嘴与鼻界面的远端之间的鼻界面中的夹带端口;通气机和气体传输回路,其中通气机经由气体传输回路与喷嘴流体连通;和在与鼻界面的远端相距一个距离处在夹带端口的位置以在鼻界面内部生成负压区域的速度将气体从喷嘴传输到鼻界面内,其中鼻界面适于在负压区域与鼻界面的远端之间生成正压区域,并且其中基本上所有呼出气体流经夹带端口并且几乎没有呼出气体流经气体传输回路。气体的传输可以与病人的呼吸同步。
通过考虑下列详细说明、附图和权利要求,附加的特征、优点和本发明的实施例就被阐明或显而易见。此外,应当理解,前述发明内容和下列详细说明是示例性的并且预期提供进一步的解释而没有限制所要求保护的本发明的范围。
附图说明
附图显示了本发明的优选实施例并且与详细说明一起用来解释本发明的原理,其中,附图被包括以提供本发明的进一步理解,并且附图包含在该说明书中并构成该说明书的一部分。
图1显示了用于实施氧气疗法的现有技术的传统氧气传输套管。
图2显示了使用鼻罩并且使用CPAP或BiPAP通气模式的现有技术的传统无创通气。
图3显示了使用本发明的实施例来在走动时接收呼吸功支持的不受妨碍的病人。
图4是描述本发明的示例性系统的示意图。
图5显示了鼻界面的示例性实施例,其中一个开放的、非密封的鼻罩可以弯曲并且设计成置于使用者的鼻子下方,并且可以从脸的中线双向地延伸到鼻子的侧面。
图6显示了图5的罩的顶视图。
图7显示了沿着图6的线A-A处的罩的气体流动路径的部分的正视剖面图。
图8A显示了图5的罩的等角侧视图。
图8B显示了在图8A的线B-B处穿过罩的气体流动路径的剖视图,显示了气体传输喷嘴。
图9显示了本发明的鼻罩的一个可选实施例的视图。
图10显示了在图9的线C-C处穿过罩的气体流动路径的部分的后视剖面图。
图11显示了沿着线D-D的图9的罩的视剖图。
图12是图9的罩的前视图。
图13是罩在图12中定向时的隐线试图,显示了气体流动路径和排气流动路径。
图14是图12的罩的底视图。
图15是罩在图14中定向时的隐线视图,显示了气体流动路径和检测路径。
图16显示了由病人携带的鼻罩的替代实施例的前视图,其中罩被优化以用于最小尺寸、人机工程学、形式、装配和功能。
图17是图16中所示罩的顶视-后视图。
图18显示了穿过线E-E的穿过图16的罩的气体流动路径、检测线路和呼气路径的前剖视图。
图19A显示了图16的罩的顶视图。
图19B显示了穿过线F-F的穿过图19A的罩的气体流动路径、检测线路和呼气路径的前剖视图。
图19C显示了穿过线G-G的穿过图19A的气体流动路径的剖视图。
图20显示了没有鼻垫的图16的罩的顶视图。
图21显示了图16的罩的气体流动路径的隐线视图,显示了气体流动路径。
图22显示了图16的罩的前-底视图。
图23显示了在图22中定向时罩的隐线视图,显示了气体流动路径。
图24显示了图16的罩的替代实施例,其中罩可以在其中心部分处弯曲。
图25显示了鼻垫可以是可拆卸的。
图26是本发明的文丘里系统实施例的示意剖视图,其中气体传输喷嘴从夹带窗口的近端略微向远侧地伸出。
图27是本发明的文丘里系统实施例的示意剖视图,其中气体传输喷嘴邻近夹带窗口。
图28A是气体传输阶段期间显示的罩和文丘里系统实施例的示意剖视图,具有用于附加的声音降低、压力平衡、流量测量、气体采样、压力失真抑制和加湿传输的附加特征。
图28B显示了在呼气阶段当气体传输断开时显示的图28A的罩。
图29是图16的鼻罩组件的透视图,但是包括如图24中所示的柔性中心部分。
图30是图16的罩的顶视-后视图,该罩具有可选的后侧皮肤定位垫。
图31是一个可选实施例的示意图,其中通气气体输出至罩的一侧,且具有包括垫之间罩中卡扣装配鼻垫和柔性接头的其他特征。
图32图形地显示了当本发明用于肺疾病或神经肌肉疾病应用时本发明可以如何有利地影响病人的呼吸功。
图33在x轴上图形地显示了肺容量并且在y轴上图形地显示了肺压以显示与传统通气相比如何使用NIOV在肺模拟器台模型上实现肺容量
图34图形地显示了与氧气疗法相比使用NIOV实现的肺容量,其中使用了肺模拟器台模型。
图35A图形地显示了依照一个实施例的正方形波形气体传输压力。
图35B图形地显示了图35A的容积传输。
图35C图形地显示了图35A中生成的肺压。
图35D图形地显示了依照一个实施例的正弦波形气体传输压力。
图35E图形地显示了图35D的容积传输。
图35F图形地显示了图35D中生成的肺压。
图35G图形地显示了依照一个实施例的用于一部分吸气阶段的正方形波形气体传输压力。
图35H图形地显示了图35G的容积传输。
图35I图形地显示了图35G中生成的肺压。
图35J图形地显示了依照一个实施例的多级波形气体传输压力。
图35K图形地显示了图35J的容积传输。
图35L图形地显示了图35J中生成的肺压。
图36A图形地显示了依照一个实施例的上升波形气体传输压力。
图36B图形地显示了图36A的容积传输。
图36C图形地显示了图36A中生成的肺压。
图36D图形地显示了依照一个实施例的下降波形气体传输压力。
图36E图形地显示了图36D的容积传输。
图36F图形地显示了图36D中生成的肺压。
图36G图形地显示了依照一个实施例的用于一部分吸气阶段的两级波幅波形气体传输压力。
图36H图形地显示了图36G的容积传输。
图36I图形地显示了图36G中生成的肺压。
图36J图形地显示了依照一个实施例的振荡波形气体传输压力。
图36K图形地显示了图36J的容积传输。
图36L图形地显示了图36J中生成的肺压。
图37图形地显示了依照一个实施例的呼吸频率调节的气流波幅传输的定时和波幅。
图38描述了当本发明用于治疗睡眠呼吸暂停时系统示意图。
图39是显示当用于治疗睡眠呼吸暂停时本发明的实施例的定时和操作的图形,其中包括慢加速和生物反馈算法。
具体实施方式
图1显示了用于实施氧气疗法的现有技术的传统氧气传输套管101。套管101上的伸出部105配置成进入鼻孔103。套管101的近端(未显示)可以连接至一旦检测到吸气努力就在1-6LPM下向使用者的鼻子传输连续流氧气或者传输一团氧气的氧气传输装置。图1的系统不会机械地支持病人的呼吸功,但是并不被相信可以有效防止中等到严重形式的OSA。图1的套管也用于另一种氧气传输疗法即高流量氧气疗法(HFOT),其中大于15LPM的潮湿氧气以连续流速输出至使用者的鼻子。由于HFOT所需的高流量,系统是非便携式的并且氧气必须是潮湿的。
图2显示了用于无创通气(NIV)的现有技术的呼吸支持疗法,该疗法以双水平气道正压(BiPAP)通气模式使用鼻罩201。NIV用于使病人呼吸,或者可以用于帮助病人的呼吸,在该情形中病人的自主呼吸努力触发通气机以传输基于压力或容积的机械通气(MV)。往返于肺部传输的所有容积可以传输并且从通气回路203和鼻罩201除去。
与图2相似的系统可以用于OSA,其中罩密封到脸上,这样通气气体由通气机提供并且一部分呼出的气体就穿过通过排气孔205呼出。NIV、持续性正气道压力(CPAP)和BiPAP被认为是对自主呼吸病人在临床上有效的模式和疗法。然而,这些模式和疗法不便于日常生活活动(ADL)。例如,通气机不能由病人携带,病人由于密封的罩而不能自然和自由地呼吸室内空气,并且病人的上气道不能正常和自然地作用,因为它被外罩密封密封起来,并且此外气体传输管件过于庞大而不能实际地支持移动性和ADL。
现在将参照剩余的图描述本发明的实施例。呼吸支持或气道支持是以病人不受妨碍的方式和方法提供的。无创、非密封和不阻碍的系统和方法可以允许移动性和日常生活活动。系统和方法允许从周围环境正常呼吸的感觉。系统和方法提供可以由病人很容易地承受或佩戴的、很容易地便携的系统和不会妨碍病人的气体传输管件。
系统和方法可以包括气体传输源、气体传输回路和允许经过鼻界面呼吸环境空气的鼻界面。穿过鼻界面的气体流动路径可以具有远端气体流动路径开孔。喷嘴可以与远端气体流动路径开孔相距一定距离处的鼻界面的近端相连。在特定实施例中,至少一部分夹带端口可以在喷嘴与远端气流开孔之间。喷嘴可以将气体传输到鼻界面内以在夹带端口处的气体流动路径中生成负压区域。鼻界面和喷嘴可以在夹带端口与鼻界面的远端之间生成正压区域。来自气体传输源的气体和经过夹带端口夹带的空气可以增大气道压力。
图3显示了在活动时使用本发明的实施例提供机械通气支持或呼吸功支持的病人301。
传统的通气机需要病人在接收通气支持时不动,或者使用轮椅搬运传统的通气机所需的庞大而沉重的设备。传统的通气机还需要妨碍性的密封罩和大孔气体传输管件。病人也可以佩戴通气机模块307,它可以是超小的,能够在本发明被用于呼吸机能不全时提供移动性。通气机可以由管件或其它设施309连接至空气和或氧气供给311。通气机模块307可以包括显示器313和/或输入装置。
本发明可以包括以小孔气体传输管件连接至通气机的非密封鼻罩病人界面。鼻罩可以是独特地非密封的,这样病人就可以在接收通气支持时直接地通过罩吸入和呼出环境空气,其中在罩中有可以忽略的死腔容积。罩可以包括独特的文丘里系统,该系统可以使通气机传输相对少量的气体以实现相对高级的通气支持或气道压力。文丘里罩更详细地描述在图6-31中。
在下列披露中详细描述了鼻界面303的各种实施例。与标准面罩相比,鼻界面303可以最低程度地突出,这样病人就可以在接受治疗时正常地感觉和行动。例如,使用鼻界面和疗法,病人可以说话、吞咽、吃饭或饮水并且感觉他们像是正常地呼吸。与标准通气机管件相比,所需的气体传输管件可以非常小,这更容易允许病人带着系统四处走动,并且隐藏疗法所需的设备和管件。在使用低水平的气体容积实现治疗级的肺或气道压力的文丘里系统的效率允许气体供应相对较小,还可以实现病人的移动性和或通气设备的小型化。
虽然图3显示了病人使用本发明用于移动性,但是本发明也可以应用于睡眠呼吸障碍。在后一种情形中,本发明的优点是罩和管件小于标准的睡眠呼吸暂停疗法的罩和管件。此外,病人可以具有更直接地呼吸环境空气的感觉,这使病人更容易容忍该疗法,而不是通过机器呼吸,这是在使用标准的睡眠呼吸暂停通气装置时的感觉。
图4是描述本发明的示例性系统的框图。图4的示例性系统可以是具有如图3所示的便携式气体源的可佩戴通气机,或者可以是另一种通气机和/或气体源。示意性地显示了与系统相关的通气机和病人界面特征。图4显示了无创开放式鼻界面400。将在在此所述的各个实施例中描述无创开放式鼻界面,例如在图5-8B(弯曲的鼻罩)、图9-15(柔性接头)和图16-25及29-31(人机工程学配置)中。
通气机模块401可以包括几个其它功能附件或者与几个其它功能附件连通。图3中的通气机和病人的内部解剖学结构在图4中以图解格式显示。通常会包括鼻气流或鼻压力传感器429。可以包括发射器403以向远程位置传递关于病人、病人的疗法和通气机性能的信息用于检查、分析、远程干预、双向通信和归档。例如,可与监视和评价病人对疗法的顺应性或疗法的利用。重要信息可以是趋势化的,例如病人的呼吸速率、I∶E比、氧气使用、活动级别或呼吸深度。而且信息可以发送至通气机433,例如,发送程序指令用于针对通气机输出设置滴定选项以满足病人的需要或者像病人发送指令。病人也可以通过通气机和发射器403向远程临床医生发送信息或问题。
氧气源407和/或压缩空气源409通常包括在通气机模块401的外部。然而,在特定实施例中,如果该疗法被用于不动的使用例如在家里,则氧气源407和/或压缩空气源409可以在通气机模块401内部。可以包括混合器411以控制在气体传输回路413中部分传输的O2。脉动血氧计415可以被用于通气机模块401的滴定设定以满足病人的生理需要,例如设置正确的氧气混合器设定或通气机容积输出。除了氧气和空气的压缩供应之外,通气机模块401可以包括内部或外部空气和氧气生成系统417,例如压缩机、泵或鼓风机来生成压缩空气,氧气发生器和/或泵来生成增压氧气,和/或压缩气体蓄积器。氧气源也可以是液体氧气或液体氧气生成系统。可以包括内部或外部加湿器405用于疗法的延伸使用,或者用于干燥气候中。
因为该疗法频繁地用于助于ADL并且用于促进活动,所以可以在通气机模块401内部或外部包括计步器419和/或腕动计传感器421。可选的传感器可以包括CO2传感器425,和/或外部呼吸传感器单元437。也可以存在CO2检测管路439和/或气道压力检测管路441。可以包括一个或多个其它外部传感器。例如,其它外部传感器可以包括外部呼吸传感器或呼吸努力传感器427,例如呼吸肌肉努力传感器、胸部阻抗传感器435或其它类型的传感器例如气管或其它传声器或振动传感器443或声学或超声波传感器。一个或多个外部传感器可以用作鼻气流或鼻压力传感器429的冗余传感器,或者补充从鼻气流或鼻压力传感器429获得的信息,或是代替鼻气流或鼻压力传感器429。也可以使用口腔气流呼吸传感器,例如鼻气流或鼻压力传感器429或者可以是口腔气流传感器。
可以在通气机模块401内部或外部包含药物传输模块431。因为面对当前雾化的药物传输吸入器的挑战,药物传输模块431可以用于将药物颗粒推动和沉积到呼吸系统的深处而不使用载体推进剂。因为使用该疗法的病人通常需要处方药物,所以这是便利和高效的施用药物的方式。
当该疗法用于呼吸支持时,使用者可以具有两个选项:(1)穿着或携带通气机模块401,这样使用者就可以走动或是享受日常生活活动,或者(2)固定使用,如果病人打算不动或者不具有走动的能力的话。对于后者,可选地以25-100英尺的长度提供传输回路,这样气体源和通气机模块401就可以在病人的家里不动,而病人仍然可以在佩戴界面并且接受治疗时在他们的家里来回移动。或者气体源可以是不动的,并且使用25-100英尺的软管连接至通气机模块401,这样病人可以佩戴或携带通气机模块401并且在软管的范围内活动。
通气机模块401可以包括一个或多个处理器445和一个或多个存储器447以分析信息并且输出疗法。
通气气体449可以在夹带环境空气451的速度下离开,这样如果病人自主地呼吸,通气气体449、夹带的环境空气451和自主地吸入的空气的组合就在功率下传输至病人的气道例如鼻腔455、口咽气道457、气管459、肺461和其它以在肺和气道上生成临床地有效的效果。病人可以通过鼻子或嘴呼气463。还包括各种气道,例如鼻孔气道473、鼻腔导气管475、口腔气道481、上气道477和下气道479。
当使用本发明时,虽然通过界面接收了机械支持,但是病人可以通过他们的上气道并且通过他们的鼻子正常呼吸。在呼气期间,呼出的气体优选地不进入气体传输回路而是离开鼻子或嘴直接进入环境空气,或者通过或跨过或围绕鼻界面400进入环境空气。在使用过程中例如吸气过程中,病人可以闭上他们的嘴以助于将机械支持导向下气道并且经过口腔465、舌头467的根部、腭469和食管471,或者可以使用护口器或下颚带,如果有必要的话。病人在使用该疗法时可以通过他们的嘴呼气。
图5-8B描述了具有独特的文丘里配置的非密封开放式气道鼻罩的实施例。图5描述了佩戴在人的脸上的鼻罩,且示例性气体传输显示为围绕病人的耳朵路线。图6显示了图5的罩的顶视图。图7显示了沿着中线A-A的图6的罩的剖视图,显示了罩的内部特征。图8A显示了图5的罩的顶视-侧视图并且图8B显示沿着线B-B的图8A的罩的剖视图,显示了罩的内部特征。如图6-8B所示,罩可以包括歧管517,它在歧管517内可以包括一个或多个气体流动路径601(图7)、与气体流动路径连通的一个或多个气体传输喷嘴611(图7)和通常在歧管517的近端509处或附近(图6)并且与气体传输喷嘴611连通的气体传输管附件513(图6)。
气体流动路径601可以终止于歧管517的上或上后侧上的远端气体开孔603处的远端处,就在中线503的两侧上歧管517的中线503的侧面。歧管517的每侧可以包括单独的或互连的气体流动路径601。气体流动路径601可以将通气气体导入使用者的鼻腔导气管。远端气流开孔603可以包括鼻垫515和/或与鼻垫515流体连通,且鼻垫515可以与鼻孔接合和/或紧密接触鼻孔。气体流动路径601可以近端地结束于歧管517的下、前或下前侧上的夹带孔505处的气体流动路径601的近端处或附近。气体流动路径601可以远侧地终止于远端气流开孔603处或附近。
离开在气体流动路径601内的气体传输喷嘴611的气体可以在夹带孔505处和/或附近生成负压区域。负压可以将环境空气通过夹带孔505吸入气体流动路径601。优选地,至少一部分夹带孔505位于气体传输喷嘴611与远端气流开孔603之间。该独特的文丘里配置可以允许负压区域形成于气体流动路径601中就在夹带孔505内,而在夹带孔505与远端气体开孔603之间形成正压区域。当气体从气体传输喷嘴611射出时,该气体会生成锥体气流或速度型廓。通常,如随后更详细地所述,在该锥体内的区域是正压并且在该锥体外部的区域是负压。通常,当锥体与气体流动路径601的内壁相交时,在交插点远端的整个区域在正压下。
通常,鼻界面501允许使用者通过夹带孔505将环境空气自由地呼吸到歧管517内或离开歧管517。或者,使用者可以将环境空气至少部分地吸入和离开单独的自主呼吸端口,且自主呼吸端口可以与夹带孔505分开并且沿着歧管517的气体流动路径601置于别处,这将在后面进行更加详细描述。夹带孔505可以是单个孔或多个孔,并且如果存在并且与夹带孔分开的话,自主呼吸端口可以是单个端口或多个端口。在特定实施例中,自主呼吸端口可以是大体上或基本上与远端气流开孔603一致。或者,自主呼吸端口可以是位于歧管517的上、下或前表面或是这些表面的组合上。一般而言,自主呼吸端口优选被放置成病人呼出的气体以固有速度或方向导引,这样它就不会刺激使用者。
夹带孔505优选地位于气体传输喷嘴611的尖端613附近,但是也可以放在歧管517上的其它位置。在特定实施例中,气体传输喷嘴611的尖端613可以完全地邻近夹带孔505。在其它实施例中,尖端613可以与夹带孔505的近端615大致齐平、在夹带孔505的远端617与近端615之间或与夹带孔505的远端617大致齐平。
夹带孔505可以置于歧管517的横向近端509附近并且可以在歧管517的上表面、前表面、下表面或是其组合上。夹带孔505可以是可变地调节的。例如,夹带孔505可以在全开与全闭之间调节。调节可以将通气支持的级别调节为总系统针对流行情况提供的期望级别。调节可以是手动的,但是优选是自动的,使用阀例如由从通气机通过小孔管道向阀传输的压力信号控制的阀。或者,气体传输喷嘴611相对于夹带孔505的位置可以由滑动机构手动或自动地调节。支持的级别可以在从局部支持到完全通气机支持的范围内变化。
如图7中所示,本发明的特定实施例的气体传输喷嘴611可以邻近夹带孔505,或者如其他实施例中所示,气体传输喷嘴611可以邻近夹带孔505的至少一部分。
相反,典型的射流泵系统会将喷嘴置于夹带端口远端或者与夹带端口同心。在本发明中气体传输喷嘴611的近端定位优选地允许歧管517内部的气流在最短的可能长度或距离中发展成正压层流,这优选地使突出最小化,而这是一个显著的优点。在气体进入病人中之前,在歧管517内形成分层正压气流是一个显著的优点。进入鼻子的湍流对病人是不舒服的。典型的射流泵不关心在射流泵区域中生成正压层流,射流泵的目标是使离开射流泵区域的压力最大。如果进入病人,湍流会包括将生成会增大噪音的剪切效应和刺激鼻组织的边界效应的涡旋和速度。由本发明生成的层流可以平缓流量型廓,这样涡旋和速度型廓就更均匀,将噪音和刺激降低为应用可接受的级别。例如,湍流可以包括大于300lpm的局部速度流,而本发明的层流可以基于名义工况生成小于200lpm的最大局部速度流。
在本发明的特定实施例中,气体流动路径横截面面积可能不会在夹带孔505与气体流动路径601的远端之间减小,而典型的射流泵系统包括横截面的减小,这会增大压力输出但是会减小流速吞吐量,而这在医学通气应用中是不希望出现的。基本上一致或可选地增大气体流动路径601的近端与远端之间的横截面面积会使由系统传输到病人中的流速最大化,而且同时减少穿过歧管517的吸气和呼气阻力。在可选实施例中,气体传输喷嘴611可以置于歧管517中鼻垫515的底座附近、鼻垫515内或者歧管517中与鼻垫515相邻任意距离处。
可能希望测量传输给病人的压力,这可以通过终止于正压区域中的检测端口619处的压力检测管腔621检测正压区域中歧管517内的压力实现,如图7中所示。歧管517内部的压力可以由通气机中的传感器由连接压力分接头607到传感器上的管道连续地测量。理想地,压力分接头607可以终止于气体流动路径601中具有尽可能少的失真的点处,通常尽可能靠近远端气流开孔603。压力分接头607通常包括压力检测端口619和延伸回通气机并且与通气机控制系统连通的检测管腔621。
可以测量歧管517内部的压力以检测病人的呼吸、确定呼吸阶段、病人状态和通气气体的适当的传输时间以及出于报警和控制系统的目的监视病人和通气压力。
一个或多个其它呼吸传感器可以位于歧管517内部或歧管517的表面上,如图4中的鼻气流或鼻压力传感器429所示。一个或多个其它呼吸传感器可以置于由气体传输喷嘴611导致的失真例如真空信号最低程度地影响的位置中。一个或多个其它呼吸传感器可以是其它类型的传感器,例如热、声、振动、气体组成、湿度和力或其任意组合。一个或多个其它呼吸传感器可以用于测量呼吸压力,但是也可以用于测量呼吸气流或其它呼吸相关的参数例如声音或气体组成。在歧管517内部可以有呼吸传感器的组合和/或在歧管517外部有一个或多个呼吸传感器。呼吸传感器可以与歧管517形成一个整体,或者在通气机(未显示)内远离鼻界面501定位。可以有两个呼吸传感器,每个鼻孔一个,或者只有单个呼吸传感器。对于一个鼻孔可以有多个呼吸传感器,例如,一个吸气呼吸传感器和一个呼气呼吸传感器。传感器也可以用于测量气流和气体容积,例如通气机传输的气体和自主呼吸气体的吸入和呼出流速及吸入和呼出潮流气量。除呼吸检测之外,设备也可以包括气体组成传感器例如呼气末CO2传感器和氧传感器。CO2是一个进行测量和响应的有用的临床参数,并且也可以用作附加的呼吸检测器、呼吸暂停检测器、泄漏检测器和界面装配检测器(特定的特征CO2信号可以表示界面的适当或不适当的装配和布置)。氧气检测可以是进行测量的一个有用参数并且可以用于确定由系统向病人传输的FIO2并且因此可以用作测量参数并且进行通气机调节来实现期望的FIO2。
罩可以设计成从鼻子侧向地弯曲并且向后地远离鼻子,这会将罩的组件与鼻子横向地放置,这会使罩尽可能地不突出。罩因此不会阻碍说话或吃饭,并且远离视线。歧管517可以通常成形为复合弓形以匹配脸下方和鼻子侧面的轮廓。歧管517通常可以双向和向后地弯曲。歧管517也可以在侧向地和向后地弯曲时向上或向下地弯曲。罩可以是双侧组件,意味着气体传输管件507连接至左侧和右侧,或者它可以是单侧的,意味着气体传输管件507仅连接至一侧。后一种配置可用于侧睡或减少脸的一侧上的突出。
图5-8B描述了没有陡角的弯曲的流动路径和在歧管517并没有气动地互连的分开的左和右流动路径。陡角可以基本上是90度。陡角可以阻碍层流的形成并且因此是不希望的。气体传输管件507可以围绕着使用者的耳朵路线,或是不同地路线。气体传输管件507可以包括用于从通气机传输气体的通道和附加的管腔,例如可以在图28中发现的管腔,例如压力检测管腔、气体采样管腔或加湿传输管腔。
歧管517的总横截面几何形状为大致圆形或半圆形的,或者可以是D形、卵形或可变的从而优化性能和人机工程学。横截面面积可以是可变的、从邻近远端可变地增大和/或不变的。可以工效学地设计不会从使用者的皮肤伸出很远的较为扁平的横截面几何形状。歧管517的内部结构可以没有角落和急剧的弯曲和角度以便于高效的气流流体动力学和声音的产生。急剧的弯曲或角度可以是不同于大约90度、优选地大约120-150度的弯曲或角度。
歧管517可以由半刚性材料构成,可以为热塑性材料或弹性材料,在其中期望歧管517为柔性的应用中通常具有30-60的肖氏A硬度,并且在其中期望歧管517为刚性或半刚性的应用中具有60-90的肖氏A硬度。歧管517也可以由半刚性或刚性和柔性材料构成,例如刚性结构用于气体流动路径601和/或检测管腔621部分。软柔性材料可以在一个或多个拐点处发现,如针对图9-31在下文中所述,或是围绕气体流动路径601和/或检测管腔621部分。或者,歧管517的外皮或后侧可以是软和柔性的,而歧管517的前侧可以是刚性或半刚性的。
歧管517也可以构成为韧性的或可由使用者模制的供使用者进行小的调节以允许鼻界面501理想地适应个人。总鼻界面501是可拆卸的,这样使用者可以拆开该组件进行清洁,或者将正确尺寸的不同零件装配在一起以定制装配。歧管517和鼻垫515,如果包括的话,通常是半透明的,而且可以是透明或不透明的。气体流动路径601的几何形状的横截面可以是圆形的或者可以是非圆形的例如D形、卵形或椭圆形,从而优化流体动力学、声音和人机工程学。歧管517中的气体流动路径601可以尺寸设计成病人能够通过气体流动路径601自由地呼吸而不会感到受到限制。通常,气体流动路径601和文丘里设计成在气体流动路径601向上朝远端气流开孔603弯曲之前在气体流动路径601内形成正压。气体流动路径601可以是弯曲的并且没有陡角和角落以使用尽可能少的阻力和干扰引导气体,并且这样由气体传输喷嘴611传输的气体就以最小湍流的以有组织的流量型廓流动。
气体传输喷嘴611的尖端613的内径的直径或有效直径可以在大约0.010″到大约0.080″之间,并且直径或有效直径优选地在大约0.020″到大约0.060″之间。取决于特定使用,其它尺寸也是可能的。气体传输喷嘴611在歧管517内部并且相对于夹带孔505的位置可以调节,这样调节就可以改变提供的通气支持的级别。通常地,气体传输喷嘴611是双侧放置的;然而,单个气体传输喷嘴也是可以预期的。
来自通气机的补充的通气气体可以从通气机经由气体传输管件507传输至歧管517,而气体传输管件507可以联接到歧管517的横向近端509。气体传输管件507可以包括通气机气体传输通道和压力检测管道以及其它通道比如CO2采样通道或加湿传输通道,如图4中所述。气体传输管件507通常围绕耳朵延伸以将鼻界面501固定到病人上,或者可以在使用者的脸上的其他位置线路,例如围绕嘴角到脖子的前面,在此情形中可以包括带以将歧管517捆在脸和头部上。
鼻垫515可以与远端气流开孔603联接并且从它向上地延伸。鼻垫515可以紧密接触鼻孔边缘、密封在鼻孔边缘上、密封在鼻孔内部、紧密接触鼻子下面的组织或是上述的各种组合。鼻垫515通常是软的和顺应性的以允许与鼻孔的舒适的接触,并且如果希望存在密封,就以舒适的方式压在鼻孔上。鼻垫515通常包括卷绕,其形状允许伸出部在多个平面中弯曲,并且沿着中心线轴压缩以符合使用者的鼻子。鼻垫515可以密封在鼻孔边缘或鼻孔的其他部分上,这样在鼻垫515与鼻子之间就不会有无意的泄露并且这样大部分的呼吸气体就会流经鼻垫515。然而,该密封并不需要是不漏的,并且在一些实施例中在鼻垫515与鼻孔之间可以有期望的气流。鼻垫515可以是永久地附着到鼻界面501上或可以可移除地装接。鼻垫515可以以不同的尺寸可用,这样使用者就可以选择匹配他们的解剖学结构的尺寸。
图9-15描述了歧管901的一个可选实施例。图9显示了歧管901的顶视图。图10显示了图9远端气流开孔线C-C处的歧管901的剖视图,显示了内部特征,包括气体流动路径903、互连通道905、气体传输喷嘴907、压力检测管腔909、压力检测端口911、夹带孔913、气体采样通道/自主呼吸孔915、排气流动路径917和远端气流开孔919。在本实施例中,自主呼吸是通过夹带孔913和排气流动路径917实现的。图11显示了在图9的线D-D处的横截面端视图,显示了内部特征,包括气体传输喷嘴907、气体流动路径903、呼吸和歧管压力检测管腔909、气体采样通道/自主呼吸孔915和排气流动路径917。歧管901可以沿着中心线925弯曲。
如图10中所示,左和右气体流动路径903可选地与互连通道905气动地连接在一起。通道905可以用于在一个鼻通道堵塞时均衡向每个鼻孔的气流传输。提供互连通道905可以允许左和右气体流动路径903中的正压均衡。互连通道905可以是固定的不变的通道,或者可以是具有可以按需改变流量特性的阀的通道。互连通道905的横截面面积通常大于气体流动路径903的横截面面积的一半。在一个可选实施例中,歧管901和气体流动路径903还可包括辅助通道、排气流动路径917,用于将离开病人的呼出的气体和由罩传输给病人的气体的气流分开。将这些路径分开可以显著地减少当这些气流分享共同的路径时在气体同时离开和传输至病人时发生的剪切。剪切的减少导致由系统产生的声音的降低,这在本发明的预期应用例如移动通气支持和睡眠呼吸障碍中是一个显著的优点。当包括排气流动路径917时,排气流动路径917可以允许病人除了通过夹带孔913吸气之外还通过排气流动路径917吸气。由病人吸入的总气体可以是下列的组合:(1)经过气体传输喷嘴907从通气机传输的补充的通气气体,(2)由离开气体传输喷嘴907的通气气体经过夹带孔913抽吸的夹带的空气,和(3)由使用者自己的自主呼吸努力经过夹带孔913或自主呼吸端口抽吸的空气。呼出的气体可以通过夹带孔913、通过歧管901内的其它端口、通过病人的嘴或其任意组合完全地呼出。
在其中压力产生比使声音最小化更重要的应用中,气体传输喷嘴907的定向对准可以与歧管901的内部气体流动路径903的几何形状的平均中心线弧对齐。在如图所示的一个实施例中,然而当使声音产生减小到最低更重要时,气体传输喷嘴907可以远离中心线倾斜并且可以是偏心的,这会减少声音产生但是减小压力输出的产生。在可移动的通气应用中,由装置产生的声音和压力的平衡是通过将气体传输喷嘴907与中心线大致成10-30度的角度并且大约偏心5-25%放置气体传输喷嘴907而实现的,这会生成大约40-60dbs的声音和大约12-35cmH2O的最大压力输出。
在歧管901的近端921处的气体传输喷嘴907也可以略微地伸入歧管气体流动路径903以减少声音产生,但是不是在夹带孔913的远端,如图所示。歧管517也可以在气流开孔603的远端气流开孔919处包括鼻垫连接元件923,软垫装接到它上,且软垫与鼻孔紧密接触或接合。
图12-15更详细地描述了气体流动路径903、排气流动路径917、压力检测管腔909和压力检测端口911、气体传输喷嘴907和气体采样通道/自主呼吸孔915及夹带孔913。图13是图12中所示罩歧管前视图的隐线视图,并且图15是图14中所示罩歧管底视图的隐线视图。
图16-23描述了一个可选实施例,其中鼻罩1601包括歧管1603,歧管1603被优化用于最小的尺寸、最小的突出、人机工程学、形式和装配中的最大舒适性及最全面的功能。鼻罩1601可以包括气体传输管件1605、夹带孔1607和/或鼻垫1609。图16显示了由人佩戴的鼻罩1601的前视图。图17是图16中所示罩的顶视-后视图。
在特定实施例中,气体传输管件1605与歧管1603之间的旋转接头1631可以包括棘爪设置。这些棘爪设置接头可以用于调节歧管1603的角度以调节气体传输喷嘴的角度与病人的鼻孔气道对齐。或者,气体传输管件1605可以以不同的旋转定向连接至歧管1603以同样使气体传输喷嘴与病人的鼻孔气道对齐。
图18是图17的鼻罩1601在线E-E处的前剖视图,其中没有鼻垫。图18显示了内部歧管特征,包括互连通道1611、呼出气体排气路径1613、气体流动路径1615、压力检测管腔1617和终止于气体流动路径1615的远端1621附近的端口1619、夹带孔1607、邻近夹带孔1607的一部分放置的气体传输喷嘴1623和用于鼻垫1609的连接的杆1625。杆1625可以置于歧管1603的上表面或上-后表面上。鼻垫1609可以使用弯曲接头装接至歧管或包括拐点或波纹管以允许鼻垫1609在微小压力下屈曲、弯曲或具棱角,这样它们就与鼻孔开孔自动对准。鼻垫1609也可以向内朝歧管1603压缩,这样鼻垫1609与鼻孔之间的接触点处的接触力就被抑制和吸收。鼻垫1609可以具有从近端底座偏离中心的远端圆形或卵形开孔。例如,远端开孔可以偏向鼻垫1609的内边缘和后边缘。这些特征可以是鼻垫1609为鼻孔的柔性密封或柔性准密封并且可以使组件更容许与不同的面部结构和在被佩戴时鼻罩1601的无意的运动配合。鼻垫1609通常为顺应性材料例如肖氏硬度10-60A的硅酮或弹性或热塑材料,但是也可以使用其他材料。
图19A显示了图16的罩的顶视图。图19B显示了穿过线F-F的穿过图19A的罩的气体流动路径1615、压力检测管腔1617和排气路径1613的剖视图。图19C显示了穿过线G-G的穿过图19A的气体流动路径1615的剖视图。图20显示了没有鼻垫1609的图16的鼻罩1601的顶视图。可以包括柔性接头1627。图21显示了图16的鼻罩1601的气体流动路径1615的隐线。图22描述了图16的鼻罩1601的前视-底视图。图23显示了图22的鼻罩1601的气体流动路径1615的隐线视图。
图24是具有柔性歧管2401的装置的前视图,依照一个实施例,其中歧管2401的中心部分2403弯曲以允许对使用者的更舒适和或可靠的配合。鼻界面2405可以包括鼻垫2407、夹带孔2409和气体管件2411。图25显示了鼻垫2407可以从杆2413上拆卸下来。可拆卸的鼻垫2407允许通过替换为更适当尺寸的鼻垫2407而清洁或定制的配合。
图26是鼻罩歧管2601的剖面的示意图,描述了基本的尺寸关系。显示了一半的鼻界面,例如左侧或右侧。气体传输喷嘴2603置于歧管2601的近端2605的附近并且邻近夹带孔2607的远端2609。气体传输喷嘴2603显示为与夹带孔2607平行而不是串联或同轴放置。对于该披露,平行是指气流方向。同样地,图26的平行位置是指从气体传输喷嘴2603传输的通气气体流与经过夹带孔2607夹带的环境空气流平行。
图26的文丘里配置可以允许装置实现几件重要的事情。首先,它允许鼻界面尽可能地小,因为气体传输喷嘴2603并没有阻塞自主呼吸路径。如果气体传输喷嘴2603在自主呼吸路径中,围绕气体传输喷嘴2603的区域可能就必须更大以补偿由气体传输喷嘴2603占用的空间,这样流动路径就形成得太有抵抗力。此外,平行夹带孔2607可以允许远离嘴引导气流。而且,平行于气体传输喷嘴2603定位的夹带孔2607可能会降低由气体传输喷嘴2603生成的声音。外管2611可以是鼻垫或者可以是歧管2601。在图中外管2611显示为从近端2605扩展到远端2613,但是它可以具有不变的横截面。此外,外管2611可以是直的或弯曲的。包括在由锥体2615显示的从喷嘴发射的气体传输路径内部的区域即在锥体2615的内部以及向左的区域可以具有正压,并且锥体2615的向右和外部的区域可以具有负压。
尺寸“A”是从气体传输喷嘴2603的尖端2617到夹带孔2607的远端2609的距离。尺寸“B”是装置的喉管区域的长度。A+B应该保持为最小长度,而仍(1)生成期望的夹带,(2)生成期望的正压,并且(3)使总尺寸减小到最低用于用户接受。优化尺寸、声音和输出压力和气流要求A+B的理想尺寸。将气体传输喷嘴2603移动至夹带孔2607的远端2609可以使尺寸A为负,这需要B的匹配的增大,而这是不希望的。增大A会向远侧地移动气体传输喷嘴2603,并且导致噪音增大,而这是不希望的。将气体传输喷嘴2603的尖端2617置于夹带孔2607的中间可以优化压力和气流性能而又使尺寸和噪音减小到最低。
图27显示了图26的一个可选实施例,其中增大的声级是可接受的,并且其中气体传输喷嘴2603置于歧管2601的近端2605处并且邻近夹带孔2607。在本实施例中,图27的A1+B1等于图26的A+B,因此导致相同的长度但是增大的声音。
图28A是依照一个实施例的鼻界面2801的剖面示意图。可以使用多个压力检测端口,例如使用第一端口2803和第二压力检测端口2805来给予鼻界面2801能力以担当呼吸速度传感器并且确定在包括来自气体传输喷嘴2807的气体加上夹带的空气加上自主呼吸的空气的吸气期间和呼气期间穿过鼻界面2801的流速和容积流量。可选地,通过测量一个理想位置中的吸气阶段信号和另一个理想位置中的呼气阶段信号,可以使用多个压力检测端口位置。或者,一个理想位置可以用于测量自主呼吸压力而第二位置可以用于测量通气气体传输压力。可以在压力检测端口附近包括抑制特征(未显示)以消除失真,例如包括屏以在检测端口附近生成涡流或流抑制。
图28A描述了在通气气体传输期间且通常在病人的自主吸气阶段期间并且可选地在呼气阶段期间的系统。由通气机通过气体传输喷嘴2807传输的气体由箭头表示,夹带的环境空气由2829表示,传输至病人的气体由2827表示,并且由2831表示的剩余气体通过呼出气体排气口导出鼻界面2801以防止剩余气体2831与由喷嘴2807传输的气体和由传输的气体2829夹带的气体碰撞。在吸气已经完成之后向病人传输气体时,或者在病人的呼吸道内下游的当时条件生成足够的背压以导致气流至少部分地远离鼻子移动期间,会出现剩余气体2831。正压会生成在从气体传输喷嘴2807的气流2823的锥体的内部和远端,并且负压生成在气流2823的该锥体内部和附近。
图28B描述了通常在病人的自主呼气阶段当气体传输断开时图28A的鼻界面2801。由病人2851呼出的气体可以通过夹带孔2813离开(见2853)和/或通过呼出气体排气路径2811离开(见2855)。
倾斜的气体传输喷嘴2807可以进一步降低声音的产生。呼出气体排气路径2811或返回路径将传输的气流或排气气流分开以减少由剪切导致的声音的产生。夹带孔2813置于气体传输喷嘴2807的远端或是部分地置于其远端。一个或多个气体采样端口2815可以位于鼻界面2801内,例如用于ETCO2或FIO2采样。鼻垫2817可以位于气体流动路径远端2821处。气体流动路径远端2821可由通道2819连接或是不由通道2819连接。在气体流动路径开始朝气体流动路径远端2821向上地弯曲(见2827)之前,在气流2823的气体传输锥体内部生成的正压会在基本上恒定横截面面积喉管部分2825中生成。
可以通过主动加热增湿或通过喷洒液体粒子进入气体传输系统中,通常进入鼻界面2801,或通过向歧管气体出口路径添加热湿交换器(HME)或上述组合来向气体传输回路加湿。为了防止在鼻界面2801中发生雨水冲洗,鼻界面2801可以具有排水管线(未显示)以清除收集的所有湿气。加湿/气溶胶喷射端口2809优选地位于负压区域中,这样气溶胶就可以进入鼻界面2801。如果加湿/气溶胶喷射端口2809在正压区域内,压力就会阻止潮湿气体或气溶胶进入鼻界面2801。可选择的是,热湿交换器(HME)(未显示)可以与呼出气体排气路径2811或夹带孔2813结合。
图29是具有鼻罩2909的鼻罩组件2907夹带孔等角视图,其中鼻罩2909包括罩歧管2911、鼻垫2913、双侧气体传输管件2915、夹带孔2917、排气口2919、柔性连接器2921、Y型连接器2901、气体传输回路2903和通气机连接器2905。
图30是图29的装置与也可以用作角度调节垫的皮肤垫2923的可选实施例的顶视图。皮肤垫2923可以由符合使用者鼻子下方的脸的软弹性或粘弹性材料构成,并且可以用于缓冲和消散将鼻罩2909和歧管2911捆在使用者的脸上的所有力。皮肤垫2923可以被用于在适当的距离处使歧管2911与皮肤隔开,这样歧管2911内的远端气流开孔或鼻垫2913(如果包括的话)就会与矢平面中的鼻子入口和鼻孔适当地对齐。皮肤垫2923可以可移除地装接用于在弄脏时清洁或替换,并且可以以不同尺寸可用以设置正确的角度。皮肤垫2923的形状显示为在后侧处是凸的;然而,皮肤垫2923可以是凹的以匹配使用者的皮肤的曲率,或者可以是平的。或者,皮肤垫2923可以生成与皮肤的多个单独的接触点,例如,就在鼻子下方的点和在鼻子的每个侧向侧上的两个附加的点。皮肤垫2923的表面可以用特殊表面处理以防止它刺激使用者的皮肤或导致溃疡,例如使用润滑涂层,例如玻尿酸涂层或亲水涂层,并且可以制出凹痕这样就可以在皮肤垫2923与皮肤之间形成气阱以避免皮肤的干燥。
图31是穿过一个可选实施例的气体流动路径3101的横截面图,其中气体传输管件3103和气体传输喷嘴3105仅仅连接至歧管3107的罩的一侧以生成单侧设计。气体从歧管3107的一侧上的气体传输喷嘴3105进入歧管3107,在图31中为歧管3107左侧,不过侧面可以颠倒,并且可以在文丘里气流锥体3109的近侧上生成负压。空气可以通过歧管3107的左侧上的夹带端口3111夹带。正压可以生成在文丘里锥体3109右侧上的歧管3107内部。歧管内的正压可以由压力检测管腔3113和端口3115在歧管3107的左和右侧内测量。气体可以流出歧管远端气流开孔3117、3119。左远端气流开孔3119可以比右侧远端气流开孔3117更限制性的从而导引等量的气流到右侧远端气流开孔3117并且平衡左和右开孔之间的气体输出。歧管3107可以在歧管3107的左和右侧上或是仅在歧管3107的左侧或仅在右侧上包括用于排气3121的辅助气体流动路径。罩可以包括加湿传输端口,如图28中所示,或是气体检测组分端口、弯曲接头3123来弯曲左气体远端气流开孔3117与右气体远端气流开孔3119或鼻垫3125(如果包括的话)之间的夹角。如果包括的话,鼻垫3125可以由配合的连接特征3127可移除地装接用于清洁、替换或调节。鼻垫3125可以在其近端底座上或附近包括半或刚性环3129,在该近端底座上扣在歧管3107的配合的连接特征3127或凸台上。环形3129可以是完整的360度的环或部分的不完整的环。鼻垫3125可以在歧管3107上可旋转地调节,并且可选地具有棘爪设置用于便于正确的旋转设定。
关键功能特征的尺寸可以选择和改变以优化主要关键性能特征,例如声音、夹带气流和输出压力。功能特征可以包括但是并不限于:喉管长度和直径、气体传输喷嘴的输入压力、气体传输喷嘴的输入流速、喷嘴出口直径、喷嘴端部内径半径、从气体传输喷嘴的气体出口速度、罩的呼吸阻力、夹带孔尺寸、气体传输喷嘴到夹带孔的距离、到喉管入口的气体传输喷嘴距离、排气流动路径横截面面积、气体传输喷嘴和气体传输喷嘴同心度。
因为功能特征的尺寸可以以相反地影响性能特征的方式彼此竞争,所以优选地必须平衡这些变量以生成成功的装置。如果喉管直径减小,压力和气流可以增大,然而,呼吸阻力会增大,而这是不希望的。如果气体传输喷嘴进一步远离喉管移动,压力和夹带可能会增大,然而,噪音也可能增大,而这是不希望的。如果夹带孔横截面面积增大,夹带可以增大,然而,需要更大的总体装置以容纳更大的夹带孔。夹带孔的尺寸设计成它比喉管部分的最小横截面面积大大约0-50%并且优选地大大约10-20%以保证夹带孔不会限制呼吸阻力,并且优化夹带而又限制装置的总尺寸。如果夹带孔位置在装置的近端,则可以实现大约2-5X的夹带系数(比传输的气流多3至5倍的夹带气流)。如果夹带孔在装置的一侧上,则可以实现大约1-3X的夹带系数。可以选择侧配置以优化在输出与其中期望将呼出的气流沿自然的方向导引离开脸的预期应用之间的平衡。如果气体传输喷嘴直径减小,出口速度可以增大并且夹带可以增大,然而,该会减小输出压力,所以需要选择平衡。选择总长度,这样在流动路径转向鼻界面的鼻垫部分之前实现完全形成的正压,用于最佳的气流和压力性能。
使用下列配置变量,本发明的实施例可以实现多达35cmH2O的肺压(输出压力)并且多达150LPM的总流量(传输的流量加上夹带的流量)和大约30-60分贝的声级。表仅仅列出了示例性值并且并不解释为限制本公开。
表1:鼻罩示例性关键尺寸和值
表2:示例性通气支持参数
表3:睡眠呼吸暂停参数
注释:
*小儿和新生儿:压力和容积值低25-75%(小儿)和50-90%(新生儿)。
(1)正方形、圆形、下降、上升、正弦、振荡。
表4:附加的示例性尺寸、值和材料
所列的尺寸是示例性并且用于平均尺寸的成年人;小儿尺寸小20%,新生儿尺寸小50%。
所列的直径是有效直径(平均横截面尺寸)。
图32描述了本发明的作用机理,以及当本发明用于肺疾病或神经肌肉疾病应用时,本发明可以如何有利地影响病人的呼吸功。病人的肺容量可以曲线图示为肺压的函数,曲线内部的面积表示功,通常以焦耳每升(J/L)表示,并且对于正常呼吸的成年人可以为0.3-0.6J/L。对于呼吸受损病人,在休息期间需要4-10倍更多的功或者在努力期间需要更多功来克服组织的患病状态,例如在COPD的情形中克服静止和动态充气过度,或者在纤维化或ARDS的情况下克服高气道阻力。
在所示曲线图中,压力轴下曲线内的面积是吸气WOB,并且由压力轴上方曲线内的区域界定的面积是呼气WOB。箭头显示了单个呼吸随着时间的过去的进展,从RV开始到VT,然后从VT返回RV。RV1和VT1是不使用该疗法的残余容积和潮流气量。线3201表示自主呼吸而没有无创开放式鼻通气。线3203表示自主呼吸且具有无创开放式鼻通气,使用了吸气扩增和呼气末正压(PEEP)疗法。RV2和VT2是使用该疗法的残余容积和潮流气量。如可以看到的那样,RV随该疗法而增大,因为在该实例中,呼气流量提供为本疗法的一部分,这可以增大残余容积。重要的是,VT随着本疗法而增大并且比RV增大得更多,这表示更多容积由于该疗法而进入和离开肺。潮流气量的增大被认为是临床上有效的,然而在开放式通气、无创和最低程度突出的系统中实现在技术上存在挑战。如曲线图中所示,当本发明为打开(ON)时病人的吸气WOB可以比本发明为关闭(OFF)时病人的吸气WOB小大约25%。而且,吸气肺压增大(负值较小)并且潮流气量增大,并且可选地,如果在呼气期间提供该疗法,呼气压力会增大。虽然在所示实例中残余容积会因为通气机在此实例中呼气阶段期间提供气体而增大,但是通气参数可以滴定为不影响残余容积,并且因为当接受该疗法时病人锻炼他们的肺肌的能力,病人的肺机构可能在COPD的情形中重塑,实际上导致残余容积减小为更正常的值。在所示曲线图中,具有该疗法的波形对通气机吸气阶段疗法输出采取早期吸气触发时间,并且容积输出在病人的吸气时间内传输。然而,可选地,可以执行能够调节WOB曲线的不同的传输波形和传输同步。例如,通气机吸气阶段疗法可以在人的吸气循环中较晚传输,且传输在吸气结束时完成,且使用正方形或上升波形轮廓传输。在这种情形下,使用该疗法的WOB曲线将向曲线的右侧向上倾斜,这样吸气就在肺压零轴上方的点处结束并且过渡到呼气。
图33图形地显示了与传统的通气相比较在肺模拟器台模型上使用NIOV实现的肺容量。在所有波形中,模拟病人在造成245ml的潮流气量的相同吸气努力下自主地呼吸,并且临床目标是将病人的潮流气量从245ml(见3301)增大到380ml(见3303)。在曲线图中从左到右的第一波形中,病人的呼吸3305是未辅助的并且因此病人接受245ml的潮流气量。在下一个波形中,具有相同努力的模拟病人被辅助以传统的封闭系统通气机,例如使用密封的呼吸面罩或翻边的气道管。通气机输出3309设置为一个级别从而实现380ml的期望的“辅助”潮流气量。通气机设置为420ml以实现该目标,因为在由通气机传输至肺的气体与由通气机传输到时并未达到肺并且浪费到环境3307中的气体之间存在差异。在第三波形中,小泄漏导入传统的通气机系统中,例如在对病人切断通气机的情况下完成的那样。为了实现380ml的期望的“辅助”潮流气量,通气机显著必须设置在705ml处。在第二和第三波形中,还可以看到,由病人的肺接受的所有容积源于通气机,而它必须在这些传统系统中。在第四波形中,病人辅助以NIOV,并且可以看出,NIOV通气机输出仅仅必须设置在90ml处以实现380ml的期望的“辅助”级别。在这种情形下,380ml潮流气量中仅仅一些来自通气机,并且380ml中的相当部分来自夹带和自主吸入的环境空气,因此使NIOV系统比其他系统更加高效、舒适和健康。
图34使用肺模拟器台模型图形地显示了与氧气疗法比较的NIOV。在左边的第一波形上,病人未被辅助并且在-0.8cmH2O的努力下呼吸,生成248ml的吸入潮流气量3401。在第二波形和第三波形中,病人分别经由鼻套管接收氧气的连续流3403和脉动流3405,而对于肺压和潮流气量没有或具有可忽略的效果。在第四波形中,使用了NIOV 3407,这显示出肺压和潮流气量的显著增加,因此表示NIOV有助于此前所述的呼吸功,尽管NIOV是开放式气道系统。
图35A-35L显示了本发明的示例性通气气体传输型廓和它们对肺容量和肺压各自的影响。
图35A、35D、35G和35J显示了由通气机传输的示例性压力和/或流量波形。图35A描述了在完全吸气循环期间的正方形波形3501;图35D描述了上升和下降波形3503;图35G描述了用于病人的自然吸气时间的第一部分传输的正方形波形3507;图35J显示了具有在吸气阶段期间传输的第一波幅3511和在呼气阶段传输的第二波幅3513的多级波幅波形3509,其中第二波幅3513例如被用于传输呼气末正压(PEEP),这在一些临床应用中是有效的。其它波形也包括在本发明中,例如下降梯形或上升梯形方波。从通气机进入气体传输管件的压力和流速输出通常在5-40psi和6-30lpm的范围内。
图35B、35E、35H和35K描述了由该疗法传输的肺容量,包括通气机输出3515和夹带的容积3517。
图35C、35F、35I和35L显示了没使用由虚线3519表示的疗法的肺压,和使用由实线3521表示的疗法的生成的肺压,在图35C中显示对于整个吸气阶段为正吸气压力,在图35F和35I中对于吸气阶段的一部分为正吸气压力,且疗法延伸到呼气3523中,并且在图35L中显示了提高的负吸气压力。
图36A-36L描述了本发明的附加的示例性通气气体传输型廓和它们对肺容量和肺压的各自的影响。
图36A描述了上升波形3601。图36D描述了下降波形3603。图36G描述了多级波形3605,它在吸气阶段的第一部分中具有较低的波幅,例如以在呼吸阶段中较早地向肺传输必需的氧气分子,并且在吸气阶段的第二部分中具有较高的波幅,例如以传输疗法的机械支持部分以助于呼吸功。图36J描述了振荡波形3607,它可以更高效地使用气体供应而又生成几乎相同的文丘里、夹带和治疗效果。
图36B、36E、36H和36K描述了由该疗法传输的肺容量,包括通气机输出3609和夹带的容积3611。
图36C、36F、36I和36L显示了没有使用由虚线3613表示的疗法的肺压,和使用由实线3615表示的疗法的生成的肺压。
由该疗法生成的肺压可以由下列因子的组合控制:气体传输回路压力、射流泵设计和配置、病人的肺顺应性和气道阻力、病人的呼吸努力、通气机输出相对于病人的吸气阶段的定时以及通气机输出波形。然而,通常,传输具有正方形波形的100ml的30psi的气体传输回路压力和在病人的吸气阶段开始时传输500msec可以增大肺压5-15cmH2O。并且,通常传输具有梯形波形的250ml的30psi的气体传输回路压力和在病人的大部分吸气阶段期间传输700msec可以使肺压增大10-25cmH2O。由通气机传输的气体可以是氧气、空气、氧气-空气混合物或治疗气体例如氦气。在本发明的主要作用机理中,病人的肺压和肺容量增大,这允许病人自己运用它们而不必受到疲劳和呼吸困难的限制。在本发明的另一个主要作用机理中,病人响应由疗法提供的压力和容积支持减小他们的呼吸努力,因此不会从该疗法导致总肺容量的变化,但是会生成减少的呼吸功。在本发明的另一个主要实施例中,可以出现上述两个作用机理的组合。
图37是依照一个实施例的定时和气流传输的图形。气流传输速度3701的波幅使用呼吸速率调节以影响气道压力3703。呼吸速率越快,波幅越高。除非由使用者改变,否则容积传输可以在宁静状态和施加状态之间维持在恒速下。然而,由系统传输的功率量可以在施加状态期间更高,因为流速越快,就会夹带更多气体,这会在吸气阶段期间生成更多功率和更高的肺压。另外,传输流量的传输时间可以由使用者调节为呼吸周期的百分比。例如,如果呼吸周期是3秒,25%的传输时间设定将等于0.75秒的传输流量脉冲宽度。传输流量脉冲宽度将随呼吸速率而改变;然而,它可以继续为呼吸周期的25%(除非由使用者改变)。设定可以在例如呼吸周期的15%至70%的范围内设置。设定可以不依赖于容积设定。例如,一个25%对40%的设定仍然可以传输相同的设定容积,并且可以仅仅以不同流速传输设定容积。用于调节传输流量脉冲时间的算法可以例如查看在前的3到5次呼吸以确定当前呼吸周期是什么,并且可以具有校正系数以排除异常的呼吸。
图38描述了当用于治疗睡眠呼吸暂停时,示例性总系统3801的示意图。在本实施例中,通气机3809从气体生成系统3825例如涡旋泵向鼻界面3805传输气体。
病人可以使用通气气体传输回路3803、气道压力检测管路3804和非密封鼻界面3805,用无创开放式通气(NIOV)通气。鼻界面3805优选地不密封在病人的鼻子上例如其它通气界面典型具有的,而是使鼻子敞开供使用者从周围环境正常和自由地呼吸。从通气机3809传输的通气气体3807可以移动通过通气气体传输回路3803并且到鼻界面3805中的一个或多个气体出口3811之外。通气气体3807可以在夹带环境空气3813的速度下离开,这样如果病人自主地呼吸,通气气体3807、夹带的环境空气3813和自主地吸入的空气3815的组合就在功率下传输至病人的气道例如鼻腔3817、口咽气道3819、气管3821、肺3823和其它以在肺和气道上生成临床有效的效果。病人可以通过鼻子或嘴呼气(见3816)。
鼻界面3805的几何形状和尺寸可以优化系统的物理和流体动力学以使性能和用户可接受度及容忍度最优化。系统的性能可以生成肺容量的增大或肺压的增大或使用者的呼吸功的减小或气道压力的增大。
NIOV通气系统也可以包括与气体供应或气体生成系统3825流体连通的通气机3809。通气机3809和/或气体供应或气体生成系统3825可以是单独的或在单个通气系统3827中。通气气体3807在呼吸机能不全应用的情形中可以是氧气,在睡眠呼吸暂停或神经肌肉应用中可以是空气,可以是其组合或是任何其它临床有益的气体。通气机3809可以具有控制单元或系统。在供应通气气体3807之前,通气机3809可以通电并且可以具有预定时间的延迟。在预定时间以后,通气机3809可以按需传输气体,例如与呼吸模式同步。
自主呼吸传感器3829也可以经由与通气系统3827的连通用于检测、确定和测量病人的自主呼吸模式和阶段以及呼吸暂停或呼吸不足事件,并且还确定和测量其他病人参数例如呼吸速率或活动级。使用该信息,通气机3809然后可以针对病人的需求同步和滴定疗法并且匹配气体传输与病人的呼吸用于最大的舒适性和治疗滴定。
附加的传感器3831可以用于检测呼吸努力。本发明可以用于支持病人的呼吸,包括通过增大肺中的压力和容积支持呼吸功,并且可以用于保持上气道例如口咽气道3819的气道开放。当使用本发明时,虽然通过界面接收了机械支持,但是病人可以通过他们的上气道并且通过他们的鼻子正常呼吸。在呼气期间,呼出的气体优选地不进入气体传输回路而是离开鼻子或嘴直接进入环境空气,或者通过或跨过或围绕鼻界面3805进入环境空气。在使用过程中例如吸气过程中,病人可以闭上他们的嘴以助于将机械支持导向下气道并且绕着口腔3833、舌头3835的根部、腭3837和食管3839,或者可以使用护口器或下颚带,如果有必要的话。气体传输可以与病人的呼吸阶段同步循环地或连续地或如在后续部分中所述的那样其组合的传输。病人可以在不动时、在输送时、在移动和活动时或在休息或睡眠时使用该疗法。该疗法具有家庭护理、医院、亚急性护理、紧急、军事、大流行和输送应用。
图39图形地描述了在用于治疗睡眠呼吸暂停时,本发明的定时和操作。顶部曲线图显示了基于测量呼吸努力例如胸部阻抗带、通过检测气管活动测量呼吸努力的颈传感器或其它传感器的病人的呼吸模式和努力3911,它被称作A。中曲线图表示由本发明的鼻罩和通气机测量的病人的气道压力信号3913,被称作B,并且下曲线图以在下曲线图下面的条3917中的不同睡眠阶段和由较低的条中表示的气道阻塞的不同阶段上指示通气机输出3915。偏流在时间3901处慢加速,通气机低输出触发在时间3903处响应信号B和可选地A被启动(波幅慢加速),通气机治疗输出触发在时间3905处响应由B和可选地A检测的减小的气流信号被启动,例如在减小的呼气气流之后的一次呼吸由B检测到,并且通气机输出触发响应呼吸暂停信号B而启动,例如在B之后的一次呼吸表示在期望呼吸时并没有呼吸,并且可选地A同时表示时间3907处的呼吸努力。
在清醒状态期间睡眠期间开始处,通气机气流输出断开,然而通气机监视功能例如气道压力监视是开启的。病人可以在该阶段中可以通过鼻罩中的自主呼吸孔自由地呼吸。在病人进入S1之前、之时或之后,当气道仍然可以开放时,通气机气体输出切换为开启状态并且在低于治疗等级的等级下不断地或间歇地传输气流和压力以使病人适应该疗法的感觉。在气道开始阻塞的一段时间之前或之后,例如当通常在S2中检测到减小的呼气气流时,通气机气流输出切换到循环输出并且慢加速至治疗输出,其中治疗输出能够防止或逆转气道阻塞并且与病人的呼吸努力同步。
理想地,因此可以防止睡眠期间的剩余部分发生气道阻塞,然而,如果检测到呼吸暂停,通气机输出可以增大,例如非同步连续流可以增大,直至再次检测到气流。另外,循环输出可以减小直到检测到减小的呼气气流,从而滴定该疗法为最低可能的级别。另外,在期间中较早地传输非治疗级别的气体也用来向系统提供关于鼻界面的装配和功能的信息。例如,呼吸压力信号可以用于确定界面是否正确地装接和对准。如果界面正确地装接,系统将检测这一点并且正常地进行,但是如果界面没有正确地装接或对准,系统将使用信号处理检测这一点,并且可以警告使用者在病人进入深睡眠阶段之前进行调整。或者,在鼻界面装接之后不久,系统就可以提供疗法的治疗级别,并且确定界面是否适当地连接,如果没有,则指导病人进行必要的调整。一旦由系统的信号处理确定了适当地装配,通气气体输出就关掉直至需要,如前面所述。
虽然前述说明指向本发明的优选实施例,但是应当指出,其他变型和修改对于本领域的技术人员将是显而易见的,并且可以做出而不脱离本发明的精神或范围。此外,结合本发明的一个实施例描述的特征可以与其它实施例一起使用,即使上文并未明示。
Claims (52)
1.一种用于提供通气支持的系统,该系统包括:
气体源;
气体传输回路;
鼻界面,允许病人通过鼻界面呼吸环境空气;
穿过鼻界面的气体流动路径,其中该气体流动路径包括远端气体流动路径开孔和朝向所述远端气体流动路径开孔的弯曲;
在与远端气体流动路径开孔相距一定距离处位于鼻界面的近端上的喷嘴,其中所述喷嘴包括尖端;
与鼻界面相连的环境空气夹带端口,其中至少一部分环境空气夹带端口位于喷嘴的尖端与远端气流开孔之间;
位于所述弯曲并终止于呼出气体排出口的辅助通道,以及
排气流动路径,所述排气流动路径通过所述鼻界面远端到所述弯曲的一部分、通过辅助通道、和通过呼出气体排出口;
其中喷嘴与气体传输回路和气体源流体连通,
其中喷嘴将气体传输到鼻界面内,其中在气体流动路径中排出喷嘴的气体在环境空气夹带端口处生成负压区域,同时在环境空气夹带端口与远端气体流动路径之间生成正压区域,其中,辅助通道在所述弯曲的位置将病人呼出的排气的流动与输送给病人的气体分开,以及
其中来自气体源的气体和通过环境空气夹带端口夹带的空气的组合提供通气支持。
2.如权利要求1所述的系统,其特征在于,鼻界面包括声音降低特征。
3.如权利要求2所述的系统,其特征在于,声音降低特征是从歧管气体流动路径中心线轴倾斜喷嘴1-30度的角度。
4.如权利要求2所述的系统,其特征在于,声音降低特征是离开歧管气体流动路径中心线5-25%放置的偏心的喷嘴。
5.如权利要求1所述的系统,其特征在于,由鼻界面生成的声音在1米处<50分贝。
6.如权利要求1所述的系统,其特征在于,气体流动路径包括基本上为横向于中线部分的第一部分和在第一部分远端的并基本上为下到上部分的第二部分,以及在第一部分和第二部分之间的弯曲,且正压区域基本上邻近该弯曲生成。
7.如权利要求1所述的系统,其特征在于,还包括终止于气体流动路径内正压区域中的压力检测端口。
8.如权利要求1所述的系统,其特征在于,气体流动路径包括左气体流动路径和单独的右气体流动路径。
9.如权利要求1所述的系统,其特征在于,左气体流动路径和右气体流动路径与互连通道气动地互连。
10.如权利要求1所述的系统,其特征在于,还包括歧管,其中该歧管在歧管中线的每侧上弯曲有侧-后-下弯曲以将歧管置于对使用者最舒服处。
11.如权利要求1所述的系统,其特征在于,还包括歧管,其中该歧管包括至少一个弯曲接头,并且该至少一个弯曲接头位于歧管的中线上。
12.如权利要求11所述的系统,其特征在于,歧管由柔性材料构成。
13.如权利要求1所述的系统,其特征在于,还包括歧管,并且其中歧管由成形为使用者的脸形的韧性材料构成。
14.如权利要求1所述的系统,其特征在于,还包括歧管和在歧管的中心处的间隔调节。
15.如权利要求1所述的系统,其特征在于,还包括装接至远端气流开孔的一个或多个鼻垫,该一个或多个鼻垫包括在枕上的扣环和围绕远端气流开孔的配合环,所述枕包括硬质材料。
16.如权利要求1所述的系统,其特征在于,还包括装接至远端气流开孔的一个或多个鼻垫,该一个或多个鼻垫包括到鼻界面的旋转连接。
17.如权利要求1所述的系统,其特征在于,气体流动路径的横截面面积从夹带端口到远端气流开孔并不减小。
18.如权利要求1所述的系统,其特征在于,气体流动路径的横截面面积从夹带端口到远端气流开孔是一致的。
19.如权利要求1所述的系统,其特征在于,气体流动路径的横截面面积从夹带端口到远端气流开孔增大。
20.如权利要求1所述的系统,其特征在于,气体从气体源的传输与吸气阶段同步。
21.如权利要求1所述的系统,其特征在于,确定病人的自主呼吸速率,基于病人的自主呼吸速率调节气体从气体源的传输时间以在不同的时间和压力幅度下传输设定容积。
22.如权利要求1所述的系统,其特征在于,来自气体源的气体由可佩戴的通气机控制。
23.如权利要求1所述的系统,其特征在于,通气支持包括减小呼吸功以治疗呼吸机能不全。
24.如权利要求1所述的系统,其特征在于,通气支持包括提高气道压力以治疗睡眠呼吸暂停。
25.如权利要求1所述的系统,其特征在于,喷嘴和气体传输管件仅仅连接至鼻界面的一侧。
26.如权利要求1所述的系统,其特征在于,气体流动路径不包括陡角。
27.如权利要求26所述的系统,其特征在于,陡角基本上是90度。
28.如权利要求1所述的系统,其特征在于,在来自气体源的气体和通过夹带端口夹带的空气的组合中,相对于来自气体源的气体,病人接收20-200%的夹带的空气。
29.如权利要求1所述的系统,其特征在于,喷嘴的尖端位于夹带端口的中点处。
30.如权利要求1所述的系统,其特征在于,喷嘴的尖端距离中心线5-60毫米。
31.如权利要求1所述的系统,其特征在于,夹带端口完全地在喷嘴的远端。
32.如权利要求1所述的系统,其特征在于,夹带端口具有0.035-0.095平方英寸的平均横截面面积。
33.如权利要求1所述的系统,其特征在于,负压区域在气体流动路径内部。
34.如权利要求33所述的系统,其特征在于,负压区域从夹带端口延伸到邻近鼻界面的远端的位置。
35.如权利要求1所述的系统,其特征在于,负压小于环境压力。
36.如权利要求35所述的系统,其特征在于,负压为-5至-40cmH2O。
37.如权利要求1所述的系统,其特征在于,正压区域在气体流动路径内部。
38.如权利要求37所述的系统,其特征在于,正压区域在气体流动路径内部从夹带端口远端的位置延伸至鼻界面的远端。
39.如权利要求1所述的系统,其特征在于,正压大于环境压力。
40.如权利要求39所述的系统,其特征在于,正压为0.01至0.50psi。
41.如权利要求1所述的系统,其特征在于,来自气体源的气体和通过夹带端口夹带的空气的组合会增大上气道压力2-35cwp。
42.如权利要求1所述的系统,其特征在于,来自气体源的气体和通过夹带端口夹带的空气的组合作为层流离开鼻界面。
43.如权利要求1所述的系统,其特征在于,鼻界面具有-0.75英寸到2.0英寸的喉管长度。
44.如权利要求1所述的系统,其特征在于,气体传输回路具有小于大约4毫米的内径。
45.如权利要求1所述的系统,其特征在于,还包括用于测量呼吸阶段的至少一个传感器。
46.如权利要求1所述的系统,其特征在于,还包括通气机,其中该通气机包括控制单元,并且其中控制单元基于来自至少一个传感器的信息调节通气机的输出以匹配病人的通气需要。
47.一种用于增大气道压力的系统,该系统包括:
气体源;
气体传输回路;
鼻界面,允许病人通过鼻界面呼吸环境空气;
穿过鼻界面的气体流动路径,其中该气体流动路径包括远端气体流动路径开孔和朝向所述远端气体流动路径开孔的弯曲;
在与远端气体流动路径开孔相距一定距离处位于鼻界面的近端上的喷嘴,所述喷嘴包括尖端;
与鼻界面相连的环境空气夹带端口,其中至所述喷嘴的尖端位于所述夹带端口的中点处;
位于所述弯曲并终止于呼出气体排出口的辅助通道,以及
排气流动路径,所述排气流动路径通过所述鼻界面远端到所述弯曲的一部分、通过辅助通道、和通过呼出气体排出口;
其中喷嘴与气体传输回路和气体源流体连通,
其中喷嘴能够将气体传输到鼻界面内以在鼻界面的近端附近的气体流动路径中生成负压区域,同时在气体流动路径内部负压区域的远端生成正压区域,其中,辅助通道在所述弯曲的位置将病人呼出的排气的流动与输送给病人的气体分开,并且其中来自气体源的气体和在气体流动路径内夹带的空气的组合增大气道压力。
48.如权利要求47所述的系统,其特征在于,负压区域从夹带端口延伸到邻近鼻界面的远端的位置。
49.如权利要求47所述的系统,其特征在于,负压小于环境压力。
50.如权利要求49所述的系统,其特征在于,负压为-10至-50cmH2O。
51.如权利要求47所述的系统,其特征在于,正压大于环境压力。
52.如权利要求51所述的系统,其中正压为2至30cmH2O。
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PCT/US2010/029875 WO2010115170A2 (en) | 2009-04-02 | 2010-04-02 | Methods, systems and devices for non-invasive open ventilation for treating airway obstructions |
USPCT/US2010/029871 | 2010-04-02 | ||
US12/753,854 US10046133B2 (en) | 2009-04-02 | 2010-04-02 | Methods, systems and devices for non-invasive open ventilation for providing ventilation support |
US12/753,851 | 2010-04-02 | ||
USPCT/US2010/029873 | 2010-04-02 | ||
PCT/US2010/029874 WO2010115169A1 (en) | 2009-04-02 | 2010-04-02 | Methods, systems and devices for non-invasive open ventilation for providing ventilation support |
PCT/US2010/047921 WO2011029074A1 (en) | 2009-09-03 | 2010-09-03 | Methods, systems and devices for non-invasive ventilation including a non-sealing ventilation interface with an entrainment port and/or pressure feature |
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CA2774902C (en) | 2017-01-03 |
WO2011029074A1 (en) | 2011-03-10 |
US11154672B2 (en) | 2021-10-26 |
US20210353884A1 (en) | 2021-11-18 |
CA2774902A1 (en) | 2011-03-10 |
CN102762250A (zh) | 2012-10-31 |
EP2473221B1 (en) | 2020-11-11 |
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EP2473221A1 (en) | 2012-07-11 |
US20190232000A1 (en) | 2019-08-01 |
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