CN101873875A - 用于在通气治疗中提供吸气和呼气流释放的方法和装置 - Google Patents
用于在通气治疗中提供吸气和呼气流释放的方法和装置 Download PDFInfo
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Abstract
提供了患者的呼吸支持和/或控制机械通气。通气设备可以包括呼吸机、经气管壁假体和呼吸释放装置。经气管壁假体和通气导管可以安置成使得患者能够通过上呼吸道和/或气管假体自由地呼吸。呼吸传感器可以测量呼吸率、肺压力、气道压力或它们的组合。在吸气过程中气体脉冲可以通过通气导管提供给患者。脉冲可以具有患者呼吸正常时的第一气量和当传感器检测到呼吸停止或呼吸量减小时的第二气量。第二气量可以以正常呼吸率的1-5倍的频率提供,或气量为第一气量的25-500%倍,或同时以这两种方式提供。
Description
本申请要求2007年9月26提交的美国临时申请No.60/960,370的权益,该申请整体上以引用方式并入本申请。
技术领域
本发明涉及为遭受呼吸障碍和呼吸疾病例如慢性阻塞性肺病(COPD)、肺纤维化、急性呼吸窘迫综合征(ARDS)、神经肌肉障碍和睡眠呼吸暂停的人进行通气治疗。
本发明尤其涉及提供用于在发生阻塞的事件中通过通气管件进行呼出和吸入的装置,否则的话患者不能通过它们的正常上呼吸道通气路径正确地吸气或呼气。
背景技术
现有技术中已知两种普通类型的呼吸机或通气控制系统。第一种类型的通气控制系统基于由临床医生选择并且独立于患者活动的频率输送气体至患者。当患者需要利用呼吸机使其呼吸时,这种类型的通气,称作″控制机械通气″(CMV)被使用。患者需要CMV时的非限定性例子包括当患者不清醒、服用了镇静剂、没有反应或瘫痪时。第二种类型的通气控制系统响应于由患者产生的吸气动作输送气体至患者。这种类型的通气,包括″辅助通气″或″增强通气″并且可以称作″呼吸支持″,可辅助患者进行呼吸。需要或可受益于这种类型通气的患者的非限定性例子包括患者遭受呼吸不足、呼吸障碍或呼吸疾病,例如患者遭受COPD、肺纤维化、急性呼吸窘迫综合征(ARDS)、神经肌肉障碍或睡眠呼吸暂停。还有的呼吸机和通气模式组合了上面描述的两种类型的呼吸机。
所有呼吸机都包括通气接口,其将呼吸机连接着患者。这些接口可以是无创或有创的。无创接口非限定性例子包括覆盖鼻和/或口的面罩。有创接口非限定性例子包括气管内管件、气管造口管件和经气管壁导管,其被置入患者气道中。
在通气中可能会遇到多种问题。本发明解决了吸气或呼气气流物理阻塞的问题,这是在通气中可能会遇到的问题之一。在机械通气的情况下,阻塞可能发生在气体传输管路或呼吸管路中的任何位置。典型地,机械通气系统中这样的阻塞要通过警报来报告并且要求值班临床医生来纠正这一问题,因为患者可能不能够这样做。在呼吸支持通气的情况下,阻塞同样可能出现在气体传输管路或呼吸管路中的任何位置。在呼吸支持通气的情况下,需要有阀布置在气体传输管路或呼吸管路中的某个位置,其可以是向大气打开的或可被打开,从而患者能够通过该阀呼吸外界空气以防止窒息。此外,如果阻塞产生过压状态,该阀或不同的阀必须自动启动或被启动以向大气打开气体传输管路,从而允许肺压力降低以防止肺气压性创伤。
在一种更为具体类型的呼吸支持通气中,患者从气体传输管路中的呼吸机接收气体,这种管路称作″开放式″系统,指的是患者的肺通过他们正常的上呼吸道呼吸路径(气管,口和鼻)向大气开通。在这种情况下,在整个本申请文件中称作″开放式通气″,患者通过他们的上呼吸道″自主地″或自然地呼吸,但他们的呼吸由于通过″开放式″气体传输管路从呼吸机接收附加气体而被增强。典型地,患者通过他们的气道直接向外界呼气并且不通过气体传输管路。然而,在一些系统或一些状况下,患者可能通过气体传输管路呼气。开放式通气系统被详细描述于美国专利申请No.2005/003472(Freitag)和美国专利申请No.2005/0005936(Wondka),每个上述申请整体上以引用方式并入本申请。开放式系统中的通气接口典型地是经气管壁导管,其通过患者的颈经皮进入气管管腔。或者,通气导管被置入不带套箍的气管造口管件、带有已放泄套箍的气管造口管件、支架或造口导向件例如MontgomeryT形管件、或气道假体例如美国专利申请No.2005/003472(Freitag)中所描述的。
在″开放式″系统通气中,需要考虑的阻塞情况是阻塞上呼吸道。可能发生的阻塞上呼吸道的非限定性例子包括口咽组织发炎;口咽组织闭合,例如这可能发生在阻塞性睡眠呼吸暂停症中;气道狭窄,例如,由气管软化引起;气道组织极性发炎;或气管造口管件上的套箍无意中充胀。如果发生任何上述事件,或其它气道阻塞时间,患者受阻或受限而不能自主地呼吸,并且通过开放式气体传输管路从呼吸机接收的气体量可能不足以维持呼吸。因此,吸气和呼气压力或气流释放机构确保在这些情况下为患者提供附加自主呼吸路径。通过标识和警告,患者可以避免任何实际安全隐患;然而,提供释放机构可为使用者提供一些显著的益处和便利,并且显著提高治疗效率,或者可以在制品误用时或在不期而至的临床事件中提供显著益处。
发明内容
本发明对现有的通气接口和通气模式作出了改进。本发明可以包括带有自主呼吸流路的通气接口,以使得如果需要的话患者能够通过接口自由地呼吸外界空气,并且在阻塞的事件中,患者被提供吸气和/或呼气的备选通路。本发明还可以包括提供在通气接口中的压力和气流释放机构,以避免不理想的肺压力,或维持期望的肺压力。
在一个实施方式中,本发明提供了一种通气设备,包括:呼吸机,气体传输管路,经气管壁假体或导管,呼吸释放装置,和至少一个呼吸传感器;其中一或多个呼吸传感器被配置成检测气道的阻塞,或被配置成在阻塞形成过程中预测气道的阻塞;并且,呼吸释放装置被配置成在检测到或预测到阻塞时打开。
在另一实施方式中,本发明提供了一种通气设备,包括:(a)呼吸机;(b)经气管壁假体,其可操作地连接着呼吸机,并且被安置成使得使用通气设备的患者能够通过患者上呼吸道自由地呼吸;以及(c)呼吸释放装置;其中呼吸释放装置安置在患者近侧并且被配置成允许使用通气设备的患者通过气管假体向外界呼气,从外界吸气,或进行这二者。
在另一实施方式中,本发明提供了一种通气设备,包括:(a)呼吸机;(b)气体传输管路,其可操作地连接着呼吸机;(c)通气导管,其可操作地连接着气体传输管路;(d)所述呼吸机被配置成在患者进行的吸气过程中通过通气导管向患者提供气体脉冲;(e)经气管壁假体,其中通气导管同轴安置在经气管壁假体中;其中经气管壁假体和通气导管被安置成使得使用通气设备的患者能够通过患者上呼吸道自由地呼吸;(f)一或多个呼吸传感器,其被配置成测量患者的呼吸率、肺压力、气道压力或它们的组合,并且确定何时患者进行吸气;(g)呼吸释放装置;其中呼吸释放装置被安置在患者近侧,并且被配置成允许使用通气设备的患者通过气管假体向外界呼气,从外界吸气,或进行这二者;其中呼吸释放装置具有打开状态和关闭状态;(h)所述一或多个呼吸传感器被配置成计算患者的正常呼吸率,患者的正常肺压力,患者的正常气道压力,或它们的组合;(i)呼吸释放装置被配置成当一或多个呼吸传感器检测出患者呼吸具有正常呼吸率、正常肺压力、正常气道压力或它们的组合时被设置在关闭状态;(j)所述一或多个呼吸传感器被配置成检测患者的呼吸率偏离正常呼吸率,患者的肺压力偏离正常肺压力,患者的气道压力偏离正常气道压力,或它们的组合;(k)呼吸释放装置被配置成响应于检测到所述偏离而自行打开或被打开。
在另一实施方式中,本发明提供了一种通气设备,包括:(a)呼吸机;(b)气体传输管路,其可操作地连接着呼吸机;(c)经气管壁假体,其可操作地连接着气体传输管路;其中经气管壁假体被安置成使得使用通气设备的患者能够通过患者上呼吸道自由地呼吸;(d)所述呼吸机被构造成在患者进行的吸气过程中通过经气管壁假体向患者提供气体脉冲;(e)一或多个呼吸传感器,其被配置成测量患者的呼吸率,肺压力,气道压力,或它们的组合,并且确定何时患者进行吸气;(f)呼吸释放装置;其中呼吸释放装置被安置在患者近侧,并且被构造成允许使用通气设备的患者通过气管假体向外界呼气,从外界吸气,或进行这二者;(g)呼吸释放装置具有打开状态和关闭状态;(h)所述一或多个呼吸传感器被配置成计算患者的正常呼吸率,患者的正常肺压力,患者的正常气道压力,或它们的组合;(i)呼吸释放装置被配置成当所述一或多个呼吸传感器检测出患者呼吸处在正常呼吸率、正常肺压力、正常气道压力或它们的组合时被置于关闭状态;(j)所述一或多个呼吸传感器被配置成检测患者的呼吸率偏离正常呼吸率,患者的肺压力偏离正常肺压力,患者的气道压力偏离正常气道压力,或它们的组合;以及(k)呼吸释放装置被配置成响应于检测到所述偏离而自行打开或被打开。
在另一实施方式中,本发明提供了一种通气设备,包括:(a)呼吸机,其被配置成:(i)在患者进行的吸气过程中向患者提供气体脉冲,其中脉冲具有第一气量;以及(ii)在检测到患者的呼吸停止或呼吸量减小后向患者提供气体脉冲,其中每个脉冲具有第二气量,其中(1)所述脉冲以正常呼吸率的1-5倍的频率提供,或(2)第二气量为第一气量的25-500%倍,或(3)所述脉冲以正常呼吸率的1-5倍的频率提供且第二气量为第一气量的25-500%倍;(b)气体传输管路,其可操作地连接着呼吸机;(c)一或多个呼吸传感器,其被配置成确定何时患者进行吸气,计算患者的正常呼吸量,检测患者的呼吸停止或呼吸量减小;以及(d)呼吸释放装置,其中呼吸释放装置被构造成允许患者向大气呼气。
在另一实施方式中,本发明提供了一种提供通气给患者的方法,包括:提供通气,所述通气提供了经气管壁、开放式、吸气同步、增强通气;进一步包括在气道阻塞的事件中,通过在通气设备中在通气接口处提供至少一个通向外界空气的开口,以提供压力或气流释放;以及进一步包括允许患者通过通气设备的经气管壁元件进行自主地呼吸。
在另一实施方式中,本发明提供了一种提供通气给患者的方法,包括(a)提供通气设备,其包括:(i)呼吸机;(ii)气体传输管路,其可操作地连接着呼吸机;(iii)通气导管,其可操作地连接着气体传输管路;(iv)经气管壁假体,其在患者的气管中,其中通气导管通过经气管壁假体进入患者的气管;其中经气管壁假体和通气导管被安置成使得患者能够通过患者上呼吸道自由地呼吸;(v)一或多个呼吸传感器,其被配置成测量患者的呼吸率,肺压力,气道压力,或它们的组合;以及(vi)呼吸释放装置;其中呼吸释放装置被安置在患者近侧,并且被构造成允许患者通过气管假体向外界呼气,从外界吸气,或进行这二者;其中呼吸释放装置具有打开状态和关闭状态;(b)使用一或多个呼吸传感器确定何时患者进行吸气;(c)在患者进行的吸气过程中通过通气导管提供气体脉冲给患者;(d)使用一或多个呼吸传感器来测量患者的呼吸率,肺压力,气道压力,或它们的组合;(e)使用一或多个呼吸传感器来计算患者的正常呼吸率,患者的正常肺压力,患者的正常气道压力,或它们的组合;(f)当一或多个呼吸传感器检测出患者呼吸具有正常呼吸率、正常肺压力、正常气道压力或它们的组合时将所述呼吸释放装置置于关闭状态;(g)使用一或多个呼吸传感器来检测患者的呼吸率偏离正常呼吸率,患者的肺压力偏离正常肺压力,患者的气道压力偏离正常气道压力,或它们的组合;以及(h)响应于检测到所述偏离打开所述呼吸释放装置。
在另一实施方式中,本发明提供了一种提供通气给患者的方法,包括(a)提供通气设备,其包括:(i)呼吸机;(ii)气体传输管路,其可操作地连接着呼吸机;(iii)经气管壁假体,其可操作地连接着气体传输管路;其中经气管壁假体安置在患者的气管内;其中经气管壁假体和通气导管被安置成使得患者能够通过患者上呼吸道自由地呼吸;(v)一或多个呼吸传感器,其被配置成测量患者的呼吸率,肺压力,气道压力,或它们的组合;以及(vi)呼吸释放装置;其中呼吸释放装置被安置在患者近侧,并且被构造成允许患者通过气管假体向外界呼气,从外界吸气,或进行这二者;(b)使用一或多个呼吸传感器来确定何时患者进行吸气;(c)在患者进行的吸气过程中通过通气导管提供气体脉冲给患者;(d)提供根据权利要求所述的呼吸释放装置,此外,其中呼吸释放装置具有打开状态和关闭状态;(e)使用一或多个呼吸传感器来测量患者的呼吸率,肺压力,气道压力,或它们的组合;(f)使用一或多个呼吸传感器来计算患者的正常呼吸率,患者的正常肺压力,患者的正常气道压力,或它们的组合;(g)当一或多个呼吸传感器检测出患者呼吸具有正常呼吸率、正常肺压力、正常气道压力或它们的组合时将所述呼吸释放装置置于关闭状态;(h)使用一或多个呼吸传感器来检测患者的呼吸率偏离正常呼吸率,患者的肺压力偏离正常肺压力,患者的气道压力偏离正常气道压力,或它们的组合;以及(i)响应于检测到所述偏离打开所述呼吸释放装置。
在另一实施方式中,本发明提供了一种提供通气给患者的方法,包括(a)使用呼吸传感器确定何时患者进行吸气;(b)在患者进行的吸气过程中提供气体脉冲给患者,其中脉冲具有第一气量;(c)使用呼吸传感器来计算患者的正常呼吸量;(d)提供呼吸释放装置,其中呼吸释放装置被构造成允许患者向大气呼气;(e)检测患者的呼吸停止或呼吸量减小;(f)在检测到患者的呼吸停止或呼吸量减小后,提供气体脉冲给患者,其中每个脉冲具有第二气量,其中(i)脉冲以正常呼吸率的1-5倍的频率提供,(ii)第二气量为第一气量的25-500%倍,或(iii)脉冲以正常呼吸率的1-5倍的频率提供且第二气量为第一气量的25-500%倍。
气体传输管路的非限定性例子包括双支呼吸管路,单支呼吸管路,单支通气气体传输管路,和小剂量通气气体传输管路。
经气管壁假体的非限定性例子包括气管管件,气管造口管件,气道导向件,导管导向件,气管假体,造口导向件,造口支架,支架,外套管,气道假体,气管支架,气管T形管件,环甲膜切开管件,和其它导向结构。
呼吸释放装置的非限定性例子包括呼吸管路外界气流端口,外界吸气释放阀,外界呼气释放阀,吸气释放阀,呼气释放阀,外界气流端口,辅助外界气流端口,主动阀,被动阀,吸气释放隔膜,呼气释放隔膜,可充胀阀,可放泄阀,可充胀/可放泄阀,弹簧加载阀,带机电作动器的阀,电磁阀,及其组合。呼吸释放装置可以总是打开的,或按要求打开和关闭或响应于一定条件打开和关闭。
当描述呼吸释放装置的部位时,″患者近侧″可以包括气管假体和通气导管之间的部位,气管假体内的部位,形成气管假体或通气导管的一部分或与其一体的部位,和形成导管连接器的一部分或与其一体的部位。
呼吸传感器的非限定性例子包括气管内传感器,例如热传感器,气道压力传感器,阻抗传感器,气流传感器,神经或肌肉活动传感器,呼吸气体传感器,血氧传感器,呼吸传感器,及其组合。作为非限定性例子,呼吸传感器可以安置在气管中(气管内),安置在经气管壁假体中,安置在患者外侧且连接着气体传输管路管腔中的气流通道,或安置在患者外侧且连接着与气体传输管路分开的气流通道。
在本发明的实施方式中,通过使用一或多个呼吸传感器,气体输送可以可选地与患者的呼吸周期同步化。优选地,呼吸机可以在患者的吸气呼吸状态中向患者提供增强气量。在本发明的实施方式中,气体输送可以可选地包括喷流动力学器件,例如使得从导管的排出速度为150米/秒以上。
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示出了一种现有技术的传统CMV闭式通气系统,典型地用于全呼吸支持。
图2示出了一种现有技术的传统CPAP闭式通气系统,典型地用于部分呼吸支持。
图3示出了一种开放式通气系统,典型地用于利用来自呼吸机的气体增强患者的自主呼吸。
图4A示出了一种开放式通气系统的一部分,其中阻塞是由意外充胀的气管造口管件套箍引起的。
图4B示出了一种开放式通气系统的一部分,其中阻塞是由气管或喉部气盗中的结构狭窄或缩窄引起的。
图4C示出了一种开放式通气系统的一部分,其中阻塞是由口咽气道中的组织发炎或坍缩引起的。
图5示出了一种开放式通气系统的一部分,其中单支呼吸管路包括外界呼吸气流端口。
图6示出了一种开放式通气系统的一部分,其中具有单支呼吸管路和显示在其打开位置的呼气释放阀。
图7示出了一种开放式通气系统的一部分,其中具有单支呼吸管路和显示在其打开位置的吸气释放阀。
图8示出了一种开放式通气系统的一部分,其中具有单支呼吸管路和组合吸气/呼气释放阀,所述阀具有显示于关闭位置的呼气部分、显示于关闭位置的吸气部分。
图9A示出了一种开放式通气系统的一部分的局部剖切侧视图,其中具有通气气体输送导管和总是打开的外界气流端口。
图9B示出了图9A中沿着线F-F所作的剖切端视图。
图10A示出了一种开放式通气系统的一部分的局部剖切侧视图,带有通气气体输送导管和被动呼出压力释放阀。
图10B示出了图10A中沿着线H-H所作的剖切端视图。
图11示出了一种开放式通气系统的一部分的局部剖切侧视图,其中带有被动外界呼气压力释放阀。
图12示出了一种开放式通气系统的一部分的局部剖切侧视图,其中带有被动外界呼气压力释放阀。
图13示出了一种开放式通气系统的一部分的局部剖切侧视图,其中带有被动外界吸气释放阀。
图14示出了一种开放式通气系统的一部分的局部剖切侧视图,其中带有被动外界吸气释放阀。
图15A示出了一种开放式通气系统的一部分的局部剖切侧视图,其中带有被动组合外界吸气和呼气释放阀。
图15B示出了图15A中沿着线P-P所作的剖视图。
图16A示出了一种开放式通气系统的一部分的局部剖切侧视图,其中带有被动组合吸气和呼气释放阀和外界气流端口,显示为吸气释放阀打开和呼气释放阀关闭。
图16B示出了一种开放式通气系统的一部分的局部剖切侧视图,其中带有被动组合吸气和呼气释放阀和外界气流端口,如图16A那样显示为呼气释放阀打开和吸气释放阀关闭。
图16C示出了图16B中沿着线N-N所作的剖切端视图,显示了阀的外界气流端口几何结构。
图16D示出了图16C所示的阀的可选的替代性外界气流端口几何结构。
图16E示出了图16C所示的阀的可选的替代性外界气流端口几何结构。
图17A示出了一种开放式通气系统的一部分的局部剖切侧视图,带有组合被动吸气和呼气释放阀,其中阀隔膜与阀座重叠。
图17B示出了图17A中沿着线R-R所作的剖切端视图。
图18A示出了一种开放式通气系统的一部分,带有用于主动吸气和呼气释放阀的充胀和放泄控制系统。
图18B示出了一种通过充胀和放泄而起作用的主动吸气和呼气释放阀的一部分的局部剖切侧视图。
图18C示出了一种用于控制可充胀主动吸气和呼气释放阀的活塞机构的侧向剖视图。
图19示出了一种开放式通气系统的一部分的局部剖切侧视图,其中主动吸气和呼气释放阀通过阀元件充胀和放泄而起作用。
图20示出了一种开放式通气系统的局部剖切侧视图,其中主动吸气和呼气释放阀通过阀元件充胀和放泄而起作用。
图21示出了一种开放式通气系统的一部分的局部剖切侧视图,其中带有主动可充胀吸气和呼气释放阀和单独的肺压力监视线。
图22A以曲线图示出了开放式通气系统中在阻塞之前和之后呼吸信号呈现的状况。
图22B以曲线图示出了开放式通气系统中在阻塞之前和之后肺压力信号呈现的状况。
图22C以曲线图示出了开放式通气系统中在阻塞之前和之后肺压力信号呈现的状况。
图22D以曲线图示出了开放式通气系统中在阻塞之前和之后肺压力信号呈现的状况。
图23示出了一种开放式通气系统的一部分的侧向剖视图,其中主动吸气和呼气释放阀带有机电式阀作动器。
图24示出了一种开放式通气系统的一部分的侧向剖视图,其中主动吸气和呼气释放阀具有先导信号控制压力释放件。
图25A示出了一种开放式通气系统的一部分的局部剖切侧视图,其中通气气体输送导管占据气管管件中的最小空间。
图25B示出了图25A中的导管的替代方案,其中导管利用线圈被稳定在中气管管件。
图25C示出了图25A中的导管的替代方案,其中导管通过被弯曲强迫抵靠在气管管件的上方内侧壁上而被稳定在气管管件中。
图25D示出了图25A中的导管的替代方案,其中导管通过被弯曲强迫抵靠在气管管件的下方内侧壁上而被稳定在气管管件中。
图25E示出了图25A中的导管的替代方案,其中导管通过被多次弯曲强迫抵靠在气管管件内侧壁上而被稳定在气管管件中。
图26A示出了一种开放式通气系统的一部分的局部剖切侧视图,其中释放阀安置在气管管件的近端。
图26B示出了一种开放式通气系统的一部分的局部剖切侧视图,其中释放阀安置在气管管件的中段。
图26C示出了一种开放式通气系统的一部分的局部剖切侧视图,其中释放阀安置成靠近气管管件的远端。
图26D示出了一种开放式通气系统的一部分的局部剖切侧视图,其中多个释放阀安置在气管管件中段和近端。
图27示出了一种带有主动套箍放泄系统的开放式通气系统的各部分。
图28示出了一种开放式通气系统的一部分的局部剖切侧视图,带有被动呼气释放阀,其中气体输送导管被置入造口导向件或支架中。
图29A示出了一种开放式通气系统的一部分的局部剖切侧视图,带有主动吸气和呼气释放阀,其中气体输送导管被置入造口支架中。
图29B示出了一种开放式通气系统的一部分的局部剖切侧视图,带有被动吸气和呼气释放阀,其中气体输送导管被置入造口导向件中。
图29C示出了一种开放式通气系统的一部分的局部剖切侧视图,带有被动呼气释放阀,其中气体输送导管被安置成穿过阀并且进入造口导向件中。
图30A示出了一种替代性释放阀的局部剖切侧视图,其中机构为叶片阀。
图30B示出了一种替代性释放阀的局部剖切侧视图,其中机构为隔膜阀。
图30C示出了一种替代性释放阀的局部剖切侧视图,其中机构为波纹隔膜阀。
图30D示出了一种替代性释放阀的局部剖切侧视图,其中机构为提升阀。
图30E示出了一种替代性释放阀的局部剖切侧视图,其中机构为鸭嘴阀。
图30F示出了一种替代性释放阀的局部剖切侧视图,其中机构为弹簧元件阀。
图30G示出了一种替代性释放阀的局部剖切侧视图,其中机构为伞形阀。
图30H示出了一种替代性释放阀的端视图,其中机构为铰接叶片阀。
图30I示出了图30H中的阀的局部剖切侧视图。
图31以曲线图示出了在窒息事件或阻塞之前和之后的潮气量和肺压力,采用了呼吸暂停或后备频率模式和主动或被动呼气释放阀。
图32以曲线图示出了在窒息事件或阻塞之前和之后的潮气量和肺压力,采用了呼吸暂停或后备频率模式,带有和不带释放阀。
附图中所用附图标记列表:
A 呼吸机气体输出
V 呼吸机
P 患者
T 气管
IL 吸气支管
EL 呼气支管
ETT 气管内管件
UA 上呼吸道
TT 气管管件或气管造口管件
I 吸气流
E 呼气流
IP 吸气压力
EP 呼气压力
t 时间轴
2 支呼吸管路
4 气管管件套箍
5 气管管件凸缘/连接器
8 吸气释放阀
10 呼气释放阀
12 单支呼吸管路
14 NIV面罩端口
16 NIV面罩
19 单支通气气体传输管路
20 小剂量通气气体传输管路
22 呼气阀
30 UA阻塞/节流部
32 OA阻塞/节流部
36 呼吸管路外界气流端口
38 外界呼气释放阀
40 外界吸气释放阀
42 外界吸气/呼气释放阀
46 外界气流端口
46A 外界气流端口
46B 外界气流端口
46C 外界气流端口
46D 外界气流端口
46E 外界气流端口
46F 外界气流端口
48 呼气释放隔膜
49 吸气释放阀
50 呼气释放阀
51 吸气/呼气释放阀
52 导管连接器
53 导管连接器
54 吸气释放隔膜
56 辅助外界气流端口
60 经气管壁通气导管
61 导管连接器
62 呼气隔膜座
64 吸气隔膜座
72 座
73 座
80 可充胀阀元件
82 阀充胀/放泄通道
84 阀座
86 可充胀/可放泄阀
88 可充胀/可放泄阀
90 压力传感器
92 充胀/放泄机构
94 气体输送机构
98 活塞机构
99 活塞
100 释放阀
102 真空源
103 密封连接器
104 密封连接器
105 密封连接器
106 导管连接器
107 导管连接器
110 感测通道
114 吹送气流
120 正常自主呼吸压力
122 减小的自主呼吸压力
124 增大的自主呼气压力
126 增大的自主吸气真空
130 阀作动器
132 滑动阀隔膜
134 主动吸气和呼气释放阀
136 阀座
140 波纹隔膜
142 先导压力信号线
143 气道压力信号线
147 阀室
152 套箍充胀管线
153 充胀管线插头
154 套箍真空管线
160 复位弹簧
161 活塞凸缘
162 活塞止挡
163 缸室
164 缸壳体
170 处理器
180 造口支架
181 造口导向件
182 气管壁
200 气管内呼吸传感器
210 盘形阀
212 隔膜阀
214 波纹隔膜
216 提升阀
218 鸭嘴阀
220 弹簧
222 弹簧阀
224 伞形隔膜阀
226 叶片阀铰链
228 阀叶片
230 叶片阀密封件
500 阻塞发生时间
502 后备频率开始时间
504 主动释放阀打开时间
506 被动释放阀打开时间
508 导管对中件
具体实施方式
图1示出了一种现有技术传统通气系统,通常称作连续机械通气(CMV)系统,其中呼吸机(V)利用双支呼吸管路(2)连接着患者(P)并且通过吸气支管(IL)输送气体至患者,且气体通过呼气阀(22)从肺排回呼气支管(EL)。典型患者通气接口为带有气管管件套箍(4)的气管内管件(ETT),以使得患者的肺相对于外界空气关闭并且只通过呼吸机呼吸管路连接着空气源。CMV系统中的呼吸机典型地包括一或多个环境释放阀以防止在阻塞或高压力事件发生时肺过压,并且使得在呼吸机发生故障时能够接通外界空气。呼吸机可包括吸气释放阀(8),从而患者,如果具有任何呼吸动作能力的话,能够打开吸气释放阀(8)并且通过其吸入外界空气。呼吸机可包括呼气释放阀(10),从而如果由于阻塞或故障而在肺中产生危险高压力,则呼气释放阀(10)能够打开并将气体排放至环境。
图2示出了一种包括呼吸机(V)的现有技术传统通气系统,典型地称作连续正气道压力(CPAP)系统。在所示出的CPAP系统中设有单支呼吸管路(12),通过其患者吸气和呼气。患者接收的所有气体是由CPAP呼吸机输送的。该系统也是闭式通气系统。患者通气接口典型地为通气面罩,通常称作无创通气(NIV)面罩(16),其抵靠着患者的面部密封,从而呼吸系统被相对于外界空气关闭。典型地,当患者至少还有一定的呼吸动作能力时,采用NIV面罩(16)的CPAP通气被使用,但仍取决于人工呼吸支持。在这个系统种,患者接收由CPAP呼吸机供应的气体;即,患者不自主地呼吸外界空气。CPAP系统包括下述中的任一:(i)位于NIV面罩上的面罩呼出端口(NIV面罩端口(14)),从而通过呼吸管路可进行呼出,或(ii)位于呼吸管路或呼吸机中的阀,其允许呼出。这些端口或阀还在通气系统故障的事件中用作释放端口。
图3示出了开放式通气系统,其中患者P通过他们的上呼吸道(UA)自然地相对于外界空气吸气I和呼气E。患者通气接口可以是气管造口管件(TT)或经气管壁导管,其典型地通过单支通气气体传输管路(19)和气体输送机构(94)连接着呼吸机(V)。气体输送机构的非限定性例子包括阀、泵、蓄积器或压缩气体供应源。在这种情况下呼吸机通过导管(未示出)向患者提供了通气辅助或增强通气,如呼吸机气体输出(A)所表示。如果气体传输管路中的位于气管造口管件(TT)和呼吸机的呼气阀(22)之间的部件的内部尺寸足够大到有效直径,典型地对于成年患者的8mm有效直径,患者可以至少部分地通过呼吸管路呼气。如果气体传输管路部件的内部尺寸小于该直径,患者主要或完全通过他们的上呼吸道呼气。示例性开放式通气系统由Freitag描述于美国专利申请No.2005/0034721、Wondka描述于在美国专利申请No.2005/0005936。出于对使用者无阻和方便的原因,或由于其他性能因素例如呼吸机气体输送动力学器件,在描述于这些申请中的开放式通气系统中,气体传输管路部件在一些情况下内径可小于4mm,在这种情况下,希望患者主要通过他们本来的呼吸路径(上呼吸道)来呼气,而不通过气体传输管路。
图4A-4C示出了可能发生并且可能损害通气系统的功能和安全的阻塞。在下面的实施方式中,阻塞和本发明揭示的用于减轻阻力的方案将结合开放式通气系统来描述;然而,应认识到,许多实施方式同样良好地应用于闭式通气系统,并且本领域技术人员能够理解如何将这些实施方式应用于这样的系统。气管管件(TT)或经气管壁通气导管(60)通过颈(184)和气管壁(182)被置入气管(T)中,并且典型地通过气管管件凸缘(5)紧固就位。
图4A示出了一种开放式通气系统的一部分,其中患者通气接口是带套箍的气管管件(TT)。需要由患者或临床医生将气管管件套箍(4)放泄以便施予开放式通气,并且需要在施予开放式通气时将套箍保持放泄状态。如果希望切换到施予封闭通气,则气管管件套箍(4)由患者或临床医生充胀。然而,如示于图4A,当开放式通气被施予时,气管管件套箍(4)可以偶然或意外充胀,因而堵塞患者的气道。
图4B示出了一种开放式通气系统的一部分,其中患者接口为例如经气管壁通气导管(60),如图所示,或是气管管件(TT)。如示于图4B,气管上呼吸道(UA)可以产生阻塞或节流部(30),由于例如声带痉挛或发炎,或气道狭窄、肿或缩窄,气道的上述变化可能由于例如、气管软化、气道支架故障、肿瘤成长、受伤或急性痉挛或肿胀而引起。
图4C示出了一种开放式通气系统的一部分,其中患者接口为例如经气管壁通气导管(60),如图所示,或是气管管件(TT)。如示于图4C,上呼吸道(UA)可以在口咽区产生节流或阻塞部(32),这种情况可能产生于例如在阻塞性睡眠呼吸暂停症中。
在施予开放式通气中可能出现在气管或上呼吸道中的阻塞事件中,例如那些示于图4A-4C的,患者不再能通过他们的上呼吸道恰当地呼吸,并且因此而依赖于呼吸机来获取空气和获取呼气途径。在呼吸机不能供应足够气量以维持呼吸和/或呼吸机不能允许患者通过通气气体传输管路呼气的事件中,需要提供一或多个机构以允许患者从环境吸入足够空气,和/或从而允许患者呼出空气至环境。
图5示出了一种开放式通气系统的一部分,该系统包括单支呼吸管路(12)和呼吸管路外界气流端口(36)。呼吸管路外界气流端口(36)在示于图5的实施方式中总是打开的,并且如果通过上呼吸道(UA)的空气流受到的阻力大于通过端口的空气流的话,患者能够通过这些端口吸气和呼气。当上呼吸道无障碍时,只有小量的空气被通过端口呼吸,因为这些端口被选择为对气流的阻力大于正常或典型患者上呼吸道中的压力,例如具有2-5倍的阻力,从而通过正常通过的呼吸占据优势,以便维持各种功能,例如说话,闻味道,吞咽,等等。端口可以优选地被构造成使得它们的阻力为3-50cmH2O/L/sec。更优选地,端口可以被构造成使得它们的阻力为8-15cmH2O/L/sec。端口可以是气体传输管路的一部分,气管管件的一部分,或用于将连接气体传输管路和气管管件互连的单独元件的一部分。端口流动阻力取决于端口的尺寸,并且端口的尺寸优选能够提供期望的阻力。气管管件可优选地为具有4-16mm内径(″ID″)和6-18mm外径(″OD″)的管件,或更优选地为适用于成人的4-8mm ID、6-12mm OD管件。管件可优选地被模制或挤出,并且由热塑性材料例如PVC形成或制出,或者可以由弹性体材料例如硅酮制成。
图6示出了一种开放式通气系统的一部分,该系统包括单支呼吸管路(12)和显示于打开位置的外界呼气释放阀(38)。显示于图6中的外界呼气释放阀(38)典型地在通气系统的正常操作中被关闭;然而,当患者不容易通过他们的上呼吸道呼气,且呼出压力超过期望的级别时,例如压力高于10-40cmH2O,外界呼气释放阀(38)打开,且肺可以通过该阀呼气至外界。外界呼气释放阀(38)可包括一或多个隔膜,一或多个叶片,或一或多个阀瓣,其抵靠着座围绕端口密封。一或多个隔膜、一或多个叶片或一或多个阀瓣可以被偏压或预加载趋向于将其保持在在关闭位置的力。一或多个隔膜、一或多个叶片或一或多个阀瓣因此具有突破压力,并且当突破压力被超过时,总是从座打开以张开或打开端口。用于本发明的实施方式中的呼气阀或隔膜的突破压力可优选地为1至50cmH2O压力,更优选地5至50cmH2O,进一步优选地10至40cmH2O,进一步优选地5至30cmH2O,进一步优选地20至25cmH2O,最优选地8至12cmH2O。突破压力也可以是可调的,例如将阀抵靠着座撑紧。在阀中,例如显示于图5,患者的呼吸状况例如患者是否在他们的上呼吸道出现节流部,将控制阀的状态,即打开或关闭。阀的状态不是由外部机械系统控制的。这种类型的阀可以称作″被动阀″。
图7示出了一种开放式通气系统的一部分,该系统包括单支呼吸管路(12)和显示于打开位置的外界吸气释放阀(40)。在示于图7的例子中,外界吸气释放阀(40)在通气系统的正常操作中典型地被关闭;然而,当患者不能通过他们的上呼吸道恰当地吸气,且由于患者吸入时的动作加大导致患者的肺压力变得更低于负值预定压力时,例如比-6至-20cmH2O更低,外界吸气释放阀(40)打开,并且患者能够通过该阀吸入外界空气。外界吸气释放阀(40)的组成部件和操作可以类似于显示于图6的外界呼气释放阀(38)的组成部件和操作。
图8示出了一种开放式通气系统的一部分,该系统包括单支呼吸管路(12)和外界吸气/呼气释放阀(42),该阀组合了示于图6和7的吸气和呼气释放功能。在图8中,外界吸气/呼气释放阀(42)的呼气部分被安置在阀的呼吸机端上,并且被显示为打开,而外界吸气/呼气释放阀(42)的吸气部分被安置在阀的患者端上,并且被显示为关闭。吸气和呼气部分的定向是示例性的,并且外界吸气/呼气释放阀(42)可以被构造成使得阀的吸气部分被安置在阀的呼吸机端上,而阀的呼气部分被安置在阀的患者端上。阀机构的每个吸气和呼气部分的组成部件和操作可以类似于显示于图6中的外界呼气释放阀(38)和显示于图7中的外界吸气释放阀(40)的组成部件和操作。
图9A示出了一种开放式通气系统的一部分,该系统包括小剂量通气气体传输管路(20)和经气管壁通气导管(60),二者均以侧视图显示,以及气管管件(TT),其以剖视图显示。小剂量通气气体传输管路(20)可以具有例如2-15mm内径的通道用于气体输送。小剂量通气气体传输管路(20)可以优选地具有3-5mm内径的通道用于气体输送。小剂量通气气体传输管路(20)的长度可以优选地为20-100英寸,更优选地30-40英寸。小剂量通气气体传输管路(20)可以具有外径(″OD″)优选为6-16mm,更优选地6-10mm;以及可以具有内径(″ID″)优选为2-10mm,更优选地3-5mm。经气管壁通气导管(60)可以是小剂量通气气体传输管路(20)的一端;或者,经气管壁通气导管(60)可以是与小剂量通气气体传输管路(20)分设的部件,并且这两个可以操作性地连接,借助于任何现有技术的适宜方法,例如通过导管连接器。经气管壁通气导管(60)可以具有例如1-5mm直径的管腔用于气体输送。经气管壁通气导管(60)可以优选地具有外径(″OD″)为6-16mm,更优选地3-10mm,更优选地8-10mm,最优选地4-6mm;以及可以优选地具有内径(″ID″)或管腔直径为0.75-3mm,更优选地1.5-2.5mm,最优选地1-2mm。经气管壁通气导管(60)可以具有相对于患者外侧与皮肤分开的长度,其优选为10-200mm,更优选地20-100mm。经气管壁通气导管(60)和气管管件(TT)之间的环形间隙优选为每侧1-5mm,更优选地每侧2-4mm,进一步优选地每侧2.5-3.5mm。外界气流端口(46)优选地具有累计横截面面积8-20mm2,更优选地10-12mm2。通过经气管壁通气导管(60)和气管管件(TT)之间环形间隙和外界气流端口(46)的气流阻力典型地为2-20cmH2O/L/sec,优选地5-15cmH2O/L/sec。气管管件(TT)可以具有相对于患者外侧与皮肤分开的长度,其优选为10-200mm,更优选地20-100mm。经气管壁通气导管(60)优选地被模制或挤出,且典型地由热塑性材料例如PVC、PVC聚氨酯混合物、或尼龙或尼龙混合物形成,或利用弹性体材料例如硅酮模制。经气管壁通气导管(60)材料优选地具有60-90肖氏硬度,从而其抵抗皱曲和弯曲。在示于图9A的实施方式中,经气管壁通气导管(60)被置入气管管件(TT)中。然而,该实施方式的经气管壁通气导管(60)可以安置在其它类型的经气管壁插管或提供通向气管的入口的假体中。经气管壁假体(transtrachealprosthesis)的非限定性例子包括气管管件,气管造口管件,气道导向件,导管导向件,气管假体,造口导向件,造口支架,支架,外套管,气道假体,气管支架,气管T形管件,环甲膜切开管件,和其它导向结构。示于图9A的实施方式包括位于导管连接器(61)中的外界气流端口(46),其将经气管壁通气导管(60)连接至气管管件。端口向着外界和气管管件敞开,并且如果通过上呼吸道的空气流受到的阻力大于通过端口的空气流,则患者能够通过气管管件经这些端口呼吸。吸气空气流和呼气释放空气流发生在经气管壁通气导管(60)和气管管件(TT)之间的环形间隙中并且通过作为导管连接器(61)的一部分的外界气流端口(46)。当上呼吸道无障碍时,只有小量的空气被通过端口呼吸,因为它们的阻力大于上呼吸道,例如具有2-5倍的阻力,如前面所解释。气管内呼吸传感器(200)被显示为与经气管壁通气导管(60)形成一体。根据需要,来自传感器的信号将呼吸机输出与患者的自主呼吸同步化;例如,用于在吸气周期中的特定点触发呼吸机以便向患者提供气体脉冲。传感器信号还提供了患者的气管和肺中的压力或流率的指示,这可以用于向使用者或呼吸机控制系统提供有关阻塞的信息,例如,减弱的气流信号可表示阻塞,或者有时增强的压力信号也可能表示阻塞。图9B描绘了小剂量通气气体传输管路(20)、外界气流端口(46A)、导管连接器(61)、外界气流端口(46)和气管管件凸缘(5)的剖切端视图。外界气流端口(46A),以及外界气流端口(46B),(46C),(46D),(46E)和(46F)(分别显示于图10B、15B、16C、16D和16E),是外界气流端口(46)的各种可行类型;每个所述类型的外界气流端口,以及其它适宜形状和构造,及其组合,可以用于本发明的任何实施方式。
呼吸(或呼吸)传感器的非限定性例子包括气管内传感器,例如热传感器,气道压力传感器,阻抗传感器,气流传感器,神经或肌肉活动传感器,呼吸气体传感器,血氧传感器,呼吸传感器,及其组合。作为非限定性例子,呼吸传感器可以安置在气管中(气管内),安置在经气管壁假体中,安置在患者外侧且连接着气流通道中的气体传输管路管腔,或安置在患者外侧且连接着与气体传输管路分开的气流通道。更具体地讲,非限定性例子包括安置在气管管腔中的热传感器,和安置在气管管腔中或安置在经气管壁假体中的气道压力传感器。
图10A示出了一种开放式通气系统的一部分,该系统包括小剂量通气气体传输管路(20)和经气管壁通气导管(60)。在该实施方式中,作为示例,经气管壁通气导管(60)被置入气管管件(TT)中。与图9A-9B中的实施方式一样,该实施方式的经气管壁通气导管(60)可以安置在其它类型的经气管壁插管或提供通向气管的入口的假体中。经气管壁通气导管(60)包括呼气释放阀(50),其包括呼气释放隔膜(48),该呼气释放隔膜在吸气过程中关闭外界气流端口(46),但在呼气过程中如果所需的条件被满足能够打开外界气流端口(46)。如果患者在呼气过程中由于阻塞或故障而经历困难,导致肺压力超过期望的级别,例如10-40cmH2O以上,压力导致呼气释放隔膜(48)弯曲,以使得隔膜移离用作呼气隔膜座(62)的导管连接器61,从而移动或弯曲离开外界气流端口(46),从而打开外界气流端口(46)并允许患者通过端口向外界呼气。图10B示出了图10A中的剖视图,显示了外界气流端口(46),呼气隔膜座(62)和气管管件凸缘(5)。呼气释放隔膜(48)可以由例如能够响应于期望的压力弯曲离开呼气隔膜座(62)的弹性膜形成。呼气释放隔膜(48)可以在自由状态中抵靠着呼气隔膜座(62)预加载,从而其抵靠着座施加轻压缩力,以使得不会在接近其突破压力时意外泄露,或者可以以下述方式成形,即在自由状态中将其抵靠着座撑紧。呼气释放阀(50)的座部通过摩擦配合连接着气管管件凸缘(5)。呼气释放隔膜(48)优选地由弹性体材料制成,例如橡胶,硅酮,或其它合成橡胶型材料,并且典型地具有0.005-0.020英寸的厚度。隔膜适宜材料的非限定性例子有热塑性硫化橡胶(TPV),例如市场上称作Santropene的材料。呼气释放隔膜(48)也可以是热塑性材料的,例如增塑PVC,或PVC-聚氨酯混合物。呼气释放隔膜(48)可以被挤出为片材,然后模切成期望的最终尺寸。优选地,呼气释放隔膜(48)是模制的。优选地,呼气释放隔膜(48)包括略微弯曲表面,其可用于在关闭状态预加载隔膜。呼气释放隔膜(48)优选地与呼气隔膜座(62)重叠。优选地,重叠量为0.5-3mm,更优选地1.0-2.0mm。一般而言,用于本发明实施方式的隔膜支靠于另一结构上。被隔膜支靠的结构可以在这里称作″呼气隔膜座(62)″或″吸气隔膜座(64)″。在某些情况下,单一结构的一部分可以用作呼气隔膜座(62),而另一部分用作吸气隔膜座(64)。
图11示出了开放式通气系统的一部分的轴向剖视图,该系统包括经气管壁通气导管(60)、气管管件(TT)和呼气释放阀,该呼气释放阀包括附连于经气管壁通气导管(60)的呼气释放隔膜(48)和气管管件(TT)的内壁上的座(72),其用作呼气隔膜座(62)。呼气释放隔膜(48)包括,例如,附连于经气管壁通气导管(60)的壁上的弹性膜。经气管壁通气导管(60)包括将其连接至气管管件(TT)的导管连接器(52)。导管连接器(52)具有穿通其中的外界气流端口(46)。在示于图11的实施方式中,阀要求经气管壁通气导管(60)和气管管件(TT)之间特征的配合。经气管壁通气导管(60)、导管连接器(52)和呼气释放隔膜(48)的尺寸协同作用而定位呼气释放隔膜(48),以使得其施加轻压力或张力于呼气隔膜座(62)。轻压力或张力可以为例如0.05-0.1磅每平方英寸,限定了阀的开启压力。如果作用于阀的压力超过其开启压力,呼气释放隔膜(48)将沿着呼气方向打开,例如如果10-40cmH2O压力施加于阀。当阀打开时,呼气释放空气流发生在经气管壁通气导管(60)和气管管件(TT)之间的环形间隙中并通过外界气流端口(46)。
重要的是需要指出,本发明包括:阀,其仅完全集成于经气管壁通气导管(60);阀,其仅完全集成于气管管件(TT);阀,其为导管和气管管件二者的一部分;和阀,其与导管和气管管件二者分开。例如,图12示出了另一开放式通气系统的一部分的轴向剖视图。在该实施方式中,呼气释放隔膜(48)附连于经气管壁通气导管(60),并且该隔膜支靠于导管连接器(52)。导管连接器(52)包括外界气流端口(46)。导管连接器(52)支靠在气管管件(TT)内侧,并且支靠于用作呼气隔膜座(62)的座(72)。当阀的开启压力达到时,隔膜移动或导致弯曲离开阀座,并且空气通过外界释放气流端口从患者流动。
图13示出了开放式通气系统的一部分的轴向剖视图,该系统包括吸气释放阀。系统包括经气管壁通气导管(60),气管管件(TT),吸气释放隔膜(54),其附连于经气管壁通气导管(60)并且抵靠着气管管件(TT)的内壁上的座(72)密封;座(72)用作吸气隔膜座(64)。导管连接器(52)附连于气管管件凸缘(5),以在尺寸上将经气管壁通气导管(60)和吸气释放隔膜(54)相对于吸气隔膜座(64)定位在正确位置。导管连接器包括外界气流端口(46)。如果突破压力阀的被超过,吸气释放隔膜(54)将沿吸气方向弯曲离开吸气隔膜座(64),例如在-6至-20cmH2O以下,这在患者经历吸气困难因而增大气道中的负压时可能发生。用于本发明实施方式的吸气阀或隔膜的突破压力可优选地为-5至-50cmH2O,更优选地-10至-40cmH2O,更优选地-10至-20cmH2O,最优选地-6至-15cmH2O。在该实施方式中,阀要求经气管壁通气导管(60)和气管造口管件(TT)之间特征的配合;然而重要的是需要指出,本发明包括:阀,其仅完全集成于通气导管;阀,其仅完全集成于气管造口管件;和阀,其为导管和外管二者的一部分。例如,图14示出了另一开放式通气系统的一部分的轴向剖视图,该系统包括吸气压力释放阀,其中吸气释放隔膜(54)、用作吸气隔膜座(64)的座(72)和外界气流端口(46)为经气管壁通气导管(60)的结构的一部分。导管连接器(52)包括外界气流端口(46),并且支靠于用作吸气隔膜座(64)的座(72)。吸气释放隔膜(54)被安置在导管连接器(52)和外界气流端口(46)的患者侧,以使得当阀的开启压力达到时,隔膜移动或导致弯曲沿吸气方向,因而允许患者通过端口和气管管件和导管之间的环形空间吸入外界空气。
图15A示出了开放式通气系统的一部分的轴向剖视图,该系统包括组合吸气和呼气释放阀。在该实施方式中,系统包括经气管壁通气导管(60)通过包括外界气流端口(46)的导管连接器(53)连接着气管管件(TT)。导管连接器(53)同时用作吸气隔膜座(64)和呼气隔膜座(62)。吸气释放隔膜(54)被安置成抵靠于吸气隔膜座(64),呼气释放隔膜(48)安置成抵靠于呼气隔膜座(62)。吸气隔膜座(64)和呼气隔膜座(62)集成于导管连接器(53)。如果其它吸入路径不可用或堵塞,吸气释放隔膜(54)打开从而允许患者吸入外界空气;如果气道或肺压力达到不理想的级别,呼气释放隔膜(48)打开从而允许从患者呼出气体。打开阀所需的患者状况和阀的开启压力如前面所描述的。图15B示出了描述于图15A的导管和气管管件的端视图。
图16A-16E示出了用于开放式通气系统的组合吸气和呼气释放阀的功能和结构。图16A示出了开放式通气系统的一部分的轴向剖视图,该系统包括组合吸气和呼气释放阀,显示了吸气释放阀处在打开位置,呼气释放阀处在关闭位置。经气管壁通气导管(60)包括导管连接器(52),其带有外界气流端口(46),并且吸气隔膜座(64)和呼气隔膜座(62)与外界气流端口(46)同轴。吸气释放隔膜(54)被显示为在其中心连接着导管,并且弯曲打开而离开中心,以允许患者通过阀和相关的外界气流端口(46)吸入外界空气;呼气释放隔膜(48)被显示于关闭位置抵靠着阀座,防止任何呼出气流流经阀和相关的外界气流端口(46)。图16B示出了开放式通气系统的一部分的轴向剖视图,该系统包括示于图16A的组合吸气和呼气释放阀,但显示出吸气释放阀和吸气释放隔膜(54)处在关闭位置,且呼气释放阀和呼气释放隔膜(48)处在打开位置。图16C-E示出了组合吸气和呼气释放阀的替代性示例性实施方式的端视图。图16C示出了外界气流端口(46D)构造为四分区,四分区中的两个与阀和吸气隔膜座(64)的吸气侧相关联,另两个四分区与阀和呼气隔膜座(62)的呼气侧相关联。图16D示出了单一外界气流端口(46E)用于吸气流,单一外界气流端口(未示出,位于呼气释放隔膜(48)后面,但具有与外界气流端口46E相同或相似的尺寸和形状)用于呼气流,其中吸气释放隔膜(54)和吸气隔膜座(64)以及呼气释放隔膜(48)和呼气隔膜座(62)被表示。图16E示出了管或孔形式的多外界气流端口(46F),其中较多孔与阀的吸气侧相关联,较少孔与阀的呼气侧相关联,以便在吸气方向产生的空气流阻力小于呼气方向。后一特征在各种应用中可能是理想的,因为吸气流释放通常比呼气流释放更紧迫,或是因为略微的正压力在肺中有时是理想的。
图17A示出了开放式通气系统的一部分的轴向剖视图,该系统包括组合吸气和呼气释放阀。经气管壁通气导管(60)安置在气管管件(TT)内。释放阀包括呼气释放隔膜(48)和吸气释放隔膜(54),它们每个包括台阶,从而与呼气和吸气隔膜座(62,64)重叠以便于有效密封并将隔膜偏压在它们的关闭位置。吸气释放隔膜(54)与吸气隔膜座(64)重叠,呼气释放隔膜(48)与呼气隔膜座(62)重叠。如图所示,吸气和呼气隔膜座(64,62)集成于气管管件(TT)结构中;或者,它们可以经气管壁通气导管(60)结构的一部分或分开的组件。图17B示出了经气管壁通气导管(60)和气管管件组件的剖切端视图,包括呼气释放隔膜(48)和吸气隔膜座(64)以及气管管件凸缘(5)或连接器。
图18A和18B示出了开放式通气系统的各部分,系统包括主动释放阀,其由患者外部的机械源打开,而非前面实施例中那样由患者的吸气或呼气动作或肺压力状况打开。在主动阀的情况下,不同于非主动或被动阀,来自控制系统的信号关闭或打开阀,基于从患者接收并且由控制系统处理的测量值。因此,主动阀的突破或开启压力不是重要设计特征。不是基于患者的吸气动作或肺压力当突破压力达到时打开,主动阀由外界力打开。控制系统基于预定判断标准和基于患者的呼吸和气道压力的实时测量值判断何时打开或关闭阀,所述实时测量值可以使用适宜的已知方法被确定。示于图18A和18B的实施方式包括小剂量通气气体传输管路(20),安置在气管造口管件(TT)内的经气管壁通气导管(60),和压力或流量释放阀。压力或流量释放阀包括阀座(84),可充胀阀元件(80),带有外界气流端口(46)的导管连接器(52),阀充胀/放泄通道(82),和呼吸机(V)内的充胀/放泄机构(92)。在示于图18B的实施方式中,释放阀是可充胀阀元件(80);然而,该可充胀阀只是示例性的,其它形式的主动阀也可以用于本发明。其它主动阀的非限定性例子包括弹簧加载阀,带机电作动器的阀,和电磁阀。在可充胀释放阀的情况下,例如示于图18B,经气管壁通气导管(60)和小剂量通气气体传输管路(20)包括管腔或阀充胀/放泄通道(82)以操作阀。可充胀阀优选地由弹性体材料例如硅酮制成,并且壁厚为0.002-0.010英寸。可充胀阀优选地要求1/4-5psi以将其充胀并抵靠着阀座密封。阀的待用状态形状接近于放泄状态形状,因而要求将材料加压和伸长以充胀到其使用尺寸。在通气系统的正常操作中,阀被充胀。在阻塞事件或过压状态发生后,阀被放泄,并且患者可借助气管造口管件通过外界气流端口(46)吸入和呼出外界空气。在所示出的实施方式中,呼吸机(V)包括充胀和放泄可充胀释放阀的机构;测量肺中的压力和/或检测肺中的过压的装置,典型地包括压力传感器(90);以及优选的处理器(170),用于接收和处理关于系统和患者状态的信号并且向控制呼吸机和释放阀发出指令。阀放泄机构可以是例如充胀/放泄机构(92),例如真空泵,其在处理器接收到来自压力测量或检测装置的信号表示肺压力已经超出期望的正或负极限后可以基于来自处理器(170)的指令被启动以放泄阀。真空泵可以用于通过将泵的入口侧和出口侧连接至阀并且相应地控制阀,从而进行可充胀阀的放泄(抽真空)和充胀(加压)这二者。或者泵可以切换,从而基于来自控制系统的信号,附连于充胀/放泄通道的输出端可从抽真空切换至加压。充胀可充胀隔膜所需的气体量优选为在受压状态下0.2-5ml,更优选在受压状态下1-3ml。
真空泵的替代物可以用作充胀/放泄机构(92),用于充胀和放泄释放阀。例如,该机构可以是机械设备,例如弹簧加载活塞机构(98),例如在图18C以剖视图表示的。该机构包括活塞(99),其移动进出缸壳体(164),以使得缸室(163)中的空气压缩或解压缩阀充胀/放泄通道(82)中的空气,这导致可充胀阀元件(80)充胀或放泄阀。弹簧加载活塞机构(98)包括活塞凸缘(161)和活塞止挡(162)以及复位弹簧(160)。为了充胀可充胀阀元件(80),作动器(未示出)推动活塞(99)沿着进入缸壳体(164)的方向离开活塞止挡(162)以便对缸室(163)和阀充胀/放泄通道(82)加压,并且因而充胀可充胀阀元件(80)。释放阀可以优选在开放式通气系统的正常操作中被充胀,从而患者主要通过他们本来的上呼吸道呼吸。然而,如果阻塞或高压力状态通过监视气道压力或呼吸而被检测到,活塞作动器接到命令以允许活塞沿着移出缸壳体(164)的方向移动以便对缸室(163)和阀充胀/放泄通道(82)解压,并且因而放泄可充胀阀元件(80),从而允许患者通过气管管件(TT)向外界空气吸气和呼气。在图18C中的系统中,活塞(99)原位位于移出缸壳体(164)的方向上,并且活塞(99)只在接收到信号表示呼吸机系统正常操作和/或患者正常呼吸时移入缸壳体(164)。这样,图18C中的系统的可以具有下述优点,即在呼吸机故障的情况下,活塞总是运行到其返回原位,因而允许患者与外界空气相通;因此,如果呼吸机有故障,患者将能与外界空气通气。
来自肺的压力信号可以通过经气管壁通气导管(60)的主气体输送管腔和小剂量通气气体传输管路(20)由呼吸机接收,或通过专用压力监视通道(未示出)。作为替代或附加,呼吸机可以使用来自另一呼吸传感器例如安置在导管上的一或多个气管内呼吸传感器的呼吸信号来测量肺压力。在呼吸被检测到时,在处理器接收到信号表示患者的呼吸已经实质上减慢或停止后,充胀/放泄机构(92)可以启动以基于来自处理器(170)的指令放泄阀。
应当指出,虽然用于充胀和放泄可充胀释放阀的机构优选地被呼吸机和传感器自动控制,但通气系统也可以包括机构,通过该机构,可充胀释放阀的充胀、放泄或充胀和放泄这二者可以由患者或临床医生手工控制。例如,系统可提供手工充胀和自动放泄,自动放泄和手工充胀,手工充胀和手工放泄,或自动放泄和自动充胀。或者,系统可以同时提供手工或自动放泄和/或充胀的选项。手工充胀和放泄可以通过下述元件实现:例如,可在呼吸机上按压的按钮,可由使用者启动的注射筒,或可由使用者挤压并实现加压和/或向外界打开的充胀和放泄囊和阀。同样的控制选项可用于其它类型的主动释放阀。
图19和20分别示出了开放式通气系统的替代性实施方式的一部分,该系统包括可充胀/可放泄主动释放阀。在图19中,局部剖视图被显示,其中可充胀/可放泄阀(86)是气管造口管件(TT)的结构的一部分,并且附连于气管造口管件(TT)的内侧壁。当放泄后,可充胀/可放泄阀(86)允许气体流动通过经气管壁通气导管(60)和气管管件(TT)之间和通过导管连接器(52)中的外界气流端口(46)。然而,当充胀(如图所示)后,可充胀/可放泄阀(86)防止气体通过气管管件(TT),并且因而患者通过他们的上呼吸道呼吸环境气体。在这种情况下,阀充胀/放泄通道(82)的一部分还是气管管件(TT)的结构的一部分。该通道可通过一段长度的管与气管管件外部的充胀/放泄机构(未示出)相连,该一段长度的管可以是:(a)气管管件(TT)的一部分,(b)经气管壁通气导管(60)的一部分,或(c)与气管管件和导管分开的管件。在图20中,显示了开放式通气系统的一部分局部剖视图,该系统包括替代性的可充胀主动释放阀。在该实施方式中,可充胀/可放泄阀(88)是导管连接器(52)的结构的一部分,并且附连于导管连接器(52)内径上的壁。当充胀后,可充胀/可放泄阀(88)向内扩张以密封抵靠于经气管壁通气导管(60)的外侧,从而关闭或堵塞外界气流端口(46)而不能气体流动。当放泄后,可充胀/可放泄阀(88)抵靠于连接器的内径,因而打开外界气流端口(46)以实现气体流动。阀充胀/放泄通道(82)与可充胀/可放泄阀(88)连通,以充胀或放泄阀。
图21示出了开放式通气系统的另一替代性实施方式的一部分的剖视图,该系统包括可充胀/可放泄阀(88)。阀是导管连接器(106)的结构的一部分。当充胀后,阀关闭外界释放端口(46);以及,当放泄后,阀打开外界释放端口(46)。阀充胀/放泄通道(82)充胀或放泄阀。与呼吸机中的压力传感器连通的感测通道(HO)可以布置成穿过导管连接器(106),并且终止于位于感测通道(110)远端的感测端口,以利用压力传感器测量压力,,该压力传感器位于气管管件(TT)和经气管壁通气导管(60)之间的环形空间中,以检测气道和肺中的过压或欠压状况。如果过压或欠压状况被检测到,则处理器向放泄机构发出信号以放泄阀,从而患者可以通过外界气流端口(46)呼气或吸气。或者,气道压力监视可以如下实现:通过测量经气管壁通气导管(60)的气体输送通道中的压力;通过测量经气管壁通气导管(60)中的辅助通道内的压力,通过使得辅助通道进一步延伸到气管管件(TT)中,该辅助通道延伸超出导管气体排出端口;或利用气管内传感器,包括集成于经气管壁通气导管(60)结构的有源感测元件。如果使用压力感测管腔,例如当测量导管气体输送通道中的压力或测量导管内的压力辅助通道中的压力时,吹送气流(114)优选地由呼吸机中的气流源产生,并且吹送气流(114)优选地维持感测管腔的开放性。
图22A-22D提供了示例性曲线图,示出了气道和肺中的状况,该状况可触发根据本发明的释放阀的操作。曲线显示了代表肺、气道和/或气管中压力的呼吸传感器信号。吸气(IP)压力在x轴下方表示,呼气(EP)压力在x轴上方表示。x轴代表时间。图22A示出了正常自主呼吸压力曲线(120)在阻塞之前可见,阻塞发生在时刻(500)。在阻塞发生于时刻(500)之后,即患者遭受阻塞时,图22A示出了自主呼吸压力曲线(122)具有减小的吸气量值。气流或压力的损失或减小可以源于减弱的呼吸动力,或者可以源于阻塞,因而阻滞气流。在根据本发明的通气系统中,当阻塞或减小呼吸动力发生后或如果存在一段时间后,一或多个释放阀被打开。或者,如显示于图22B,阻塞可引起增大的负压,如见于增大的自主吸气真空曲线(126),这可能由于增大的吸气动作以吸入空气而引起。接下来,随着压力在肺中积累,产生呼气压力升高,如见于增大的自主呼气压力曲线(124)。或者,如显示于图22C,阻塞(发生在时刻500)可引起增大的吸气动作,如增大的自主吸气真空曲线(126)所表示。或者,如显示于图22D,由于气体在肺中俘获,阻塞(发生在时刻500)可引起增加肺压力,如增大的自主呼气压力曲线(124)所表示。在任何情况下,由于穿过阻塞吸气时增强的动作或由于阻塞不允许完全呼出导致的呼吸气体俘获引起的呼吸信号中的漂移和斜度变化或呼吸信号的量值摆动,都表明开放式通气系统中有某种故障,并且需要干预~吸气压力/气流释放,或呼气压力/气流释放,或进行这二者。在图22A-22D中,压力被用作呼吸信号;然而将压力用作呼吸信号仅仅是示例性的,任何形式的能检测阻塞或减弱的呼吸动力的呼吸信号或测量值可以使用。作为非限定性例子,气管内气流传感器,胸阻抗传感器,流量传感器,气体成分传感器,脉冲血氧,呼吸神经动力信号,和肌肉活动传感器,可以用于监视呼吸。在任何情况下,一旦阻塞或减弱的呼吸动力被检测到,打开根据本发明的通气系统中的一或多个释放阀,从而将气道压力和表征信号恢复到更正常量值。
图23示出了部分轴向剖视图开放式通气系统的一部分,该系统包括主动吸气和呼气释放阀(134)。在前面描述的实施方式中,主动释放阀示出位可充胀阀;然而,根据本发明,其它类型的主动阀可以使用。图23示出了主动阀机构包括滑动阀隔膜(132),其滑动离开座(73)以便打开阀并允许气体流经设置在座(73)中的外界气流端口(46)。当阀被关闭时,滑动阀隔膜(132)被按压抵靠着座(73)。阀隔膜被控制和接受命令而由阀作动器(130)滑动至关闭或打开位置,在本例中阀作动器被描绘为电磁作动器。作动器,可选地被容纳在导管连接器(52)中,导管连接器还包括辅助外界气流端口(56)用于被空气流过。作动器可以是电动、机械、机电或电磁的。例如线圈可以用于产生磁场以移动阀隔膜,实际磁体可以用于移动隔膜,或机械衔铁可以用于物理接触和移动隔膜。阀隔膜可以由例如轻质合金制成,例如铝,其具有2-10%铁含量-如果机构是电磁的。或者,阀隔膜可以由工程塑料制成,例如聚酰亚胺热塑性树脂,例如商标名为ULTEM的商品,其中铁颗粒被混杂在该材料中。阀座优选为软质塑料,例如硅酮,以使得阀隔膜更有效地密封。
图24示出了开放式通气系统的一部分的部分轴向剖视图,该系统包括主动释放阀,其接收来自先导压力信号线(142)的先导压力的信号,以将波纹隔膜(140)支靠于阀座(136)而将阀关闭密封。先导压力信号可以是从呼吸机传输至阀的压力。作为替代或附加,如显示于图24,气道压力信号线(143)可以将气道压力施加至隔膜。当来自气道压力信号线(143)的压力信号异常时,阀室(147)变为不平衡,并且隔膜移离阀座,从而空气可在座和隔膜之间流动至环境。或者,如果先导压力信号线(142)检测到由于压力从气道压力信号线(143)施加在波纹隔膜(140)上而导致阀室压力异常,测量先导压力信号线中压力的传感器将向控制系统发送信号,以从阀室(147)排出空气,因此移动隔膜离开座和将阀向环境打开。通过必要的改造,这一原理可以应用于吸气压力释放阀或呼气压力释放阀或这二者,这些改造对于阅读了本申请文件的本领域技术人员而言是可清楚理解的。
图25A-25E示出了开放式通气系统的一部分中的通气导管的不同构造部分轴向剖视图,通气导管被安置在气管管件、外插管或导向件中。优选地,为了最大化导管与气管造口管件、外插管或导向件之间的环形横截面空间,导管直径被最小化。最大化的环形空间使得通过该空间的呼吸阻力最小化。例如,导管的外径为2mm至6mm是优选的;并且,当安置在气管管件的内径为6-10mm时,导管外径为理想的3mm-4mm是更优选的。最大化的环形空间是期望的,以使得在需要通过这个间隙进行呼吸的事件中,患者可更容易通过该环形间隙呼吸。然而,在环形空间较大的情况下,希望将导管稳定在气管造口管件中,以防止其甩动,维持其正确定向,并且如果呼吸传感器是与导管相关联的话,以防止呼吸传感器与导管一起移动至气管管件内不理想的位置。经气管壁通气导管(60)被安置在气管管件中,即利用导管连接器(61)将其连接至气管管件(TT),导管连接器典型地包括释放阀,尽管释放阀未被描绘于图25A-25E中。在图25A中,由于导管自身的刚度,导管是自稳定型的,该刚度是这样实现的,例如,利用具有60-90肖氏硬度的材料制成导管,或导管壁中包含加固线材或条,从而导管在暴露于最高达5psi的压力时可抵抗偏转。在图25B中,导管是利用无障碍低阻力导管对中件(508)稳定的。无障碍低阻力对中件的非限定性例子包括线材笼、丝状结构、辐条或线圈,由不锈钢、镍钛诺合金或热塑性材料制成。对中件引入的阻力应小于10cmH2O/L/sec,优选小于3cmH2O/L/sec。在图25C中,通过导管自身几何结构,导管被稳定下来。在该实施方式中,导管所具有的半径Rc大于气管造口管件半径Rt,从而导管在插入后沿着气管造口管件的内部上壁或后壁延伸,并且因此而稳定于此。在图25D中,通过导管自身几何结构,导管被稳定下来。在该实施方式中,导管所具有的半径Rc小于气管造口管件半径Rt,从而导管在插入后沿着气管造口管件的内部下壁或前壁延伸,并且因此而稳定于此。图25E示出了通气导管沿着其长度的至少一部分具有大致正弦曲线或螺旋结构,其中导管中曲线的最顶侧和最底侧部分接触气管造口管件的内壁,并且从而稳定导管。
图26A-26D是开放式通气系统的各部分的部分轴向剖视图。图26A-26D示出了开放式通气系统中的环境释放阀的替代性位置,该系统包括经气管壁通气导管(60)、气管管件(TT)和释放阀。前面的图中已经显示了释放阀位于通气导的近端管或气管造口管件的近端,如图26A中由吸气/呼气释放阀(51)所示;然而,释放阀可以安置在其它部位,例如在气管管件的中段,例如显示于图26B,或在气管管件的远侧部分,例如显示于图26C。在一个以上的释放阀被使用的情况下,例如分开的吸气释放阀(49)和呼气释放阀(50)被使用,阀可以安置在彼此不同的部位,例如显示于图26D。
图27示出了开放式通气系统的各部分,其中经气管壁通气导管(60)插入气管管件(TT)的管腔中,在本例中气管管件为带套箍的气管管件,用于通过经气管壁通气导管(60)施予开放式通气。如果气管管件套箍(4)被意外充胀,上呼吸道被堵塞并且患者不能通过上呼吸道自然地吸气或呼气,患者也不能通过气管管件(TT)呼吸,因为气管管件的近端被导管连接器(52)堵塞。为了防止无意中充胀气管管件套箍(4),套箍充胀管线(152)被充胀管线插头(153)堵塞,该插头可以是通气导管的构成部件,通气气体传输管路的构成部件,或单独的部件。该插头可以是″智能″插头,其发送信号例如气压信号或电接触信号至呼吸机,以使得呼吸机能够检测插头是否意外地未被连接或意外地脱离套箍充胀管线,并且因而在感测到没有连接在其中时启动警报或其它信号。因此,可利用插头来防止无意中充胀套箍或检测到这种情况。或者,套箍真空管线(154)可以附连于套箍充胀管线,在此真空管线与呼吸机中的真空源(102)连通,优选地通过集成于气体传输管路组件中的通道。这确保了套箍在施予开放式通气中处在放泄状态,从而确保患者能够通过上呼吸道进行自主呼吸,除非存在其它形式的阻塞,在这种情况下,前面描述的释放阀就有用了。尽管释放阀未被示于图27,这里描述的释放阀可以被用于该实施方式。真空可以恒定地或间歇地启动,可以在由前面描述的装置检测到阻塞后启动,或可以连续或间歇地施加。可选地,作为真空源的替代或与其组合,可以利用一个机构来调节和控制套箍的充胀和放泄,以便在封闭通气(完全充胀套箍)和开放式通气(完全放泄套箍)和/或部分开放式或封闭通气(部分地充胀套箍)之间进行切换。肺压力因此可以在施予通气治疗中进行调节。
图28示出了开放式通气系统的一部分的部分轴向剖视图,其中经气管壁通气导管(60)插入造口支架(180)的管腔中,如图所示,或插入造口导向件中。造口支架(180)安置在造口中,造口是穿过颈(184)皮肤和气管壁(182)的经皮孔。造口支架(180)包括抵靠于颈(184)外侧和抵靠于气管壁(182)前壁内侧的凸缘或翻边,以将造口支架(180)正确定位在造口中。用于将经气管壁通气导管(60)定位并连接至造口支架(180)的导管连接器(52)包括外界气流端口(46);并且导管包括呼气释放隔膜(48),其在正常操作中密封外界气流端口(46)和造口支架(180)。在该实施方式中,释放阀只是呼气释放阀;然而,通过必要的改造,释放阀可以是吸气释放阀,或组合呼气和吸气释放阀,并且能以前面所描述的方式发挥功能。
图29A-29C示出了一种开放式通气系统的一部分,显示了安置在经气管壁通气导管(60)和造口导向件(181)之间的释放阀的替代性构造。造口导向件(181)不同于图28中的造口支架(180)之处在于,造口导向件(181)突伸到患者的气管管腔中一段距离,而前述造口支架(180)与气管壁平齐。造口导向件(181)优选地突伸至大约气管管腔的中心;然而,造口导向件(181)可以突伸至任何距离。造口导向件(181)优选被弯曲以便朝向肺引导导管。图29A示出了经气管壁通气导管(60)借助于密封连接器(103)和可充胀阀元件(80)插入造口导向件(181)。图29B示出了经气管壁通气导管(60)和造口导向件(181)之间的密封连接器(104)。在图29A和29B中,密封连接器(103,104)密封造口导向件和导管之间的环形空间,从而患者不能通过造口导向件(181)呼吸;然而,密封连接器(103,104)可以在患者遭受阻塞时由患者或临床医生手工去除,或者可以构造和布置成使其在过压状态的情况下自动崩开。在图29B的实施方式中,经气管壁通气导管(60)还包括导管连接器(52),其具有穿通其中的外界气流端口(46)。当密封连接器(104)被拆下或崩开后,导管连接器(52)中的外界气流端口(46)向大气打开,并且患者就能通过造口导向件呼吸外界空气了。在图29A中的实施方式中,主动阀,例如可充胀阀元件(80),然后就能与主动释放阀一起执行前面描述的压力和气流释放的功能了。图29C示出了密封连接器(105),其包括穿通其中的外界气流端口46和呼气释放隔膜(48)。密封连接器(105)被可拆除地附连于造口导向件(181)。在该实施方式中,经气管壁通气导管(60)被布置成穿过密封连接器(105)和呼气释放隔膜(48),例如穿过密封连接器(105)中的空和呼气释放隔膜(48)中的狭缝。图29C示出了呼气释放阀;然而,穿过阀和密封连接器的插入式导管的实施方式也可结合呼气阀或组合吸气/呼气阀和结合被动阀以及主动阀。描述于图29B和29C的实施方式允许使用者从气道拆下整个经气管壁通气导管(60)和中断开放式通气治疗,在这一时间中,使用者可以选择利用密封连接器(104,105)密封造口导向件(181),或打开造口导向件(181),取决于喜好和和临床状况。
图30A-30I分别示出了释放阀开放式通气系统的一部分。这些图中显示了可以根据本发明被使用的释放阀类型的附加非限定性例子。图30A示出了盘形阀(210);图30B示出了隔膜阀(212);图30C示出了波纹隔膜(214),通过设计出可放大施加至隔膜的力的翻卷部,波纹隔膜在受到偏压时更容易在期望的方向打开。与显示于图30C的实施方式一样,波纹隔膜可以具有复合翻转部,其在一个方向翻转以便在一个方向打开而实现吸气压力释放,并且还在相反方向翻转以便在在相反方向打开而实现呼气压力释放。图30D示出了提升阀(216),图30E示出了鸭嘴阀(218),图30F示出了弹簧加载截止阀,包括弹簧(220)和弹簧加载阀(222),图30G示出了伞形隔膜阀(224)。图30H和30I描绘了带有铰链的摆动阀,其中图30I以局部剖视图描绘了摆动阀,该阀包括阀叶片(228)、叶片阀密封件(230)和外界气流端口(46)。图30H描绘了阀的端视图,显示了用于阀叶片(228)的叶片阀铰链(226)。每个这些类型的阀,以及其它适宜已知阀,及其组合,可以用于本发明的任何实施方式。可以与本发明一起使用的其它非限定性类型的阀包括薄膜截止阀,提升截止阀,鸭嘴截止阀,伞形截止阀,摆动截止阀,弹簧截止阀,隔膜截止阀,磁体截止阀,滑动衔铁截止阀,可充胀阀,可放泄释放阀,可充张/可放泄阀,弹簧加载阀,带机电作动器的阀,电磁阀,及其组合。可用于本发明实施方式中的阀包括单通阀,例如阀为沿吸气方向单通的阀,以及在呼气方向单通的阀;二通阀,例如沿吸气方向和呼气方向打开的阀;以及上述各种阀的组合。
用于本发明实施方式的呼气释放阀或隔膜的突破压力可优选地为1-50cmH2O压力,更优选地5至50cmH2O,进一步优选地10至40cmH2O,进一步优选地5至30cmH2O,进一步优选地20至25cmH2O,最优选地8至12cmH2O。用于本发明实施方式的吸气阀或隔膜的突破压力可优选地为-5至-50cmH2O,更优选地-10至-40cmH2O,更优选地-10至-20cmH2O,最优选地-6至-15cmH2O。突破压力还可由临床医生或患者调节,例如通过将阀抵靠着座撑紧。呼吸机还可以被配置成响应于一或多个传感器获得的呼吸动作或呼吸压力信息自动调节阀和隔膜的突破压力。
此外,主动和被动阀与吸气释放阀和呼气释放阀的各种组合可以根据本发明被使用。作为非限定性例子,主动吸气释放阀可以与被动呼气释放阀一起使用;被动吸气释放阀可以与主动呼气释放阀一起使用;主动吸气释放阀可以与被动吸气释放阀一起使用;呼气释放阀可以与被动呼气释放阀一起使用;并且其它组合也可以使用,包括组合使用三个或更多阀。阀的组合也可以称作″阀″或称作″呼吸释放装置(respiratory relief device)″或″多个呼吸释放装置″。一或多个阀还可以与外界气流端口和/或呼吸管路外界气流端口组合使用。一或多个阀与外界气流端口和/或呼吸管路外界气流端口的组合可以被称作″呼吸释放装置″或″呼吸释放装置″。阀还可以被构造成使得它们可以被患者或临床医生手工打开和关闭。本发明包含了其操作方法仅包括手工打开和关闭的阀;还包含下述阀,其可被动地或响应于所选择的条件或状况而主动地打开和关闭,但它们也可以被手工打开和关闭。
图31以曲线图示出了本发明的附加实施方式尤其是开放式通气系统的操作,该系统类似于前面的实施方式,然而包括呼吸暂停模式(apnea mode)或后备频率模式(back up rate mode)和主动释放阀。为了实现这一点,呼吸机包括控制系统,其从呼吸传感器接收信息并且控制后备频率模式和主动释放阀。呼吸传感器被用于测量气道和肺中的自主呼吸和压力并将该信息提供至呼吸机控制系统。呼吸机的呼吸暂停或后备频率模式被用于在当患者的自主通气由于阻塞或减弱的呼吸动力而被减弱后辅助或代替患者的自主通气,从而患者接收足够通气。至少一个释放阀被用于在后备模式操作时防止肺被呼吸机过压,否则的话会由于呼吸累加和气体排出不当导致肺压力升高。呼吸机的呼吸暂停模式,并且打开释放阀,是在呼吸传感器检测到下述情况后启动的:呼吸丧失或减小,气管气流丧失或减小,或代表患者气道的阻塞或节流的肺压力漂移。来自呼吸传感器的信号被呼吸机处理单元或控制系统接收,并且基于预定判断标准或算法,或通过实时决定性判断标准,控制系统将启动后备模式和/或打开释放阀。后备频率模式和主动释放阀可以在阻塞或窒息事件中基于已知的患者状况使用来自一或多个呼吸传感器的信息进行调节,从而通过后备频率和释放阀实现正确的肺和通气状况。当期望的状况被恢复后,基于预设的判断标准和算法,后备模式被停用且释放阀被关闭。
参看图31中的曲线图,其中x轴代表时间,阻塞发生在时刻(500),呼吸机呼吸暂停后备频率(或″呼吸暂停模式″或″后备频率模式″)开始于时刻(502),并且释放阀在时刻(504)打开,然而,在其它例子中,释放阀打开可发生在呼吸机呼吸暂停后备频率开始之前。在阻塞(发生在时刻500)之前的时间内,释放阀被关闭,呼吸传感器信号表示用于自主吸入和呼出的正常量值,在这种情况下图示为每次呼吸的潮气量(tidal volume),呼吸机输出信号表示呼吸机正在传输预先规定的每次呼吸气量或压力输送值,并且肺压力表示开放式通气系统中期望的正常吸气和呼气肺压力。在阻塞(发生在时刻500)之后的时间段中,以曲线表示呼吸暂停模式的响应,释放阀,以及这些干预对潮气量和肺压力的影响。当处在呼吸暂停模式(开始于时刻502)时,呼吸机以后备通气率操作,其中呼吸机开放式以自动频率传输通气气量,而非响应于患者吸气动作。在呼吸暂停模式中气体输送频率优选为正常自主呼吸率的1-5倍,正常自主呼吸率是由患者的历史走势或由临床正常值确定的,从而传送足够的气量以补偿患者的减小自主呼吸。作为高频率气体输送的替代或附加,增强气量可以在呼吸暂停模式中自动增大以传送足够气量,从而对患者的自主呼吸不足作出补偿。作为后备频率的附加,当肺压力达到预定阈值后,主动呼出释放阀可以根据信号打开,从而后备增强频率和气量输送不会引起危险的高肺压力。具体地讲,如果呼吸减弱由阻塞引起或部分地由阻塞引起,后备频率可能将肺压力升高至不理想的级别,因此释放阀将提供所需的安全性。或者,后备频率可能未提供足以在呼吸机周期之间呼气的时间,这会导致肺压力爬升,在这种情况下,释放阀将提供所需的安全性。
图32示出了一种实施方式,其类似于图31中的实施方式,然而不同之处在于,释放阀是被动释放阀在图31,而非主动释放阀。呼气释放阀在图31是被动释放阀,具有一定的突破压力。在图32中,阻塞发生在某个时刻(发生在时刻500),呼吸机呼吸暂停后备频率开始于时刻(502),并且被动释放阀在时刻(506)被打开。在阻塞(发生在时刻500)前的时间中,曲线表示正常潮气量和正常肺压力。阻塞之后的时间表示由于俘获气体和不完全呼出导致呼吸潮气量减小和爬升肺压力。释放阀打开表示可防止肺持续升高压力。此外假定没有释放阀的情况时的肺压力曲线也被显示在曲线图中,用于比较和参考的目的。在这种情况下,肺压力持续增加,潜在地达到不安全级别,尤其是在呼吸机后备频率被启用期间。
尽管前面的描述针对的是本发明的优选实施方式,应当指出,其它改型和改造容易被本领域技术人员理解,并且可以在不脱离本发明的精神和范围的前提下作出。另外,针对本发明的一个实施方式描述的特征可以与其它实施方式结合使用,即使前面没有专门提及。
本发明可以以其它具体形式实施,而不脱离其精神或基本特性。这样的附加实施方式和形式对于阅读了本申请后的本领域技术人员而言是清楚的。所描述的实施方式被认为在所有方面都是解释性的,而非限制性的。例如,在前面的描述中,导管常被描述为安置在气管造口管件或气管管件内,术语被可互换地使用。然而,导管可以安置在其它类型的经气管壁插管或提供通向气管的入口的假体内。这样的装置的非限定性例子包括例如气道导向件,导管导向件,气管假体,造口导向件,支架,外套管,气道假体,和其它导向结构。作为另一例子,通气输送系统典型地描述为包括经气管壁通气导管;然而,通气输送系统可包括其它类型的管件或插管,和/或除了经气管壁以外,可从其它部位/以其它方式进入气道。作为另一例子,不同的类型的阀的组合可以使用;作为非限定性例子,被动吸气阀可以与主动呼气释放阀组合使用;或者相反,主动吸气释放阀可以与被动呼气释放阀组合使用。作为另一例子,同时提供被动和主动吸气压力释放的阀可以使用。作为可以在不脱离本发明的倾天下作出各种修改的另一例子,一或多个释放阀在这里描述为经气管壁通气管件或导管的一部分,但应当理解,本发明可应用于在其它部位引入身体的患者接口,例如经环甲膜切开管件,上呼吸道管件,气管内管件和导管,和口-鼻通气管件和导管。为了简化,通气气体输送导管的各部分在各个图中常以侧视图显示仅仅导管外侧表面,而没有显示导管的气体输送管腔或壁。
还应指出,在所描述的实施方式中,释放阀被典型地描述为具有两种状态,打开状态和关闭状态。然而,其它状态也可存在,例如部分打开状态。释放阀在部分打开状态可以被用于例如将肺压力控制在期望的级别,例如在呼出相态维持5cmH2O肺压力。
尽管呼吸机(V)并不是与这里描述的所有实施方式相关地显示和描述,但本发明的实施方式一般而言可与呼吸机(V)结合使用。本发明的实施方式可以用于任何适宜的呼吸机,其非限定性例子包括固定呼吸机,适用于车辆的呼吸机,适用于家用的呼吸机,其尺寸适于被患者携带或其尺寸适于被带轮推车承载的呼吸机,可佩戴的呼吸机,和中心呼吸系统例如医疗场所使用的那些。
此外,虽然本发明被描述为用于治疗呼吸不足和气道或呼吸疾病,其还可以应用于任何通气治疗或干预,例如麻醉剂输送、药物输送等等。
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。
Claims (15)
1.一种通气设备,包括:呼吸机,气体传输管路,经气管壁假体或导管,呼吸释放装置,和至少一个呼吸传感器;其中一或多个呼吸传感器被配置成检测气道的阻塞,或被配置成在阻塞形成过程中预测气道的阻塞;并且,呼吸释放装置被配置成在检测到或预测到阻塞时打开。
2.一种通气设备,包括:
(a)呼吸机;
(b)经气管壁假体,其可操作地连接着呼吸机,并且被安置成使得使用通气设备的患者能够通过患者上呼吸道自由地呼吸;以及
(c)呼吸释放装置;其中呼吸释放装置安置在患者近侧并且被配置成允许使用通气设备的患者通过所述气管假体向外界呼气,从外界吸气,或进行这二者。
3.如权利要求2所述的通气设备,进一步包括压力传感器,用于测量肺中的压力,检测肺中的过压,或进行这二者;其中呼吸释放装置包括主动阀。
4.如权利要求2所述的通气设备,其中,呼吸释放装置包括座和隔膜;其中所述阀从肺或从呼吸机接收先导压力信号;并且,利用先导压力信号调节隔膜抵靠着座的位置。
5.一种通气设备,包括:
(a)呼吸机;
(b)气体传输管路,其可操作地连接着呼吸机;
(c)通气导管,其可操作地连接着气体传输管路;
(d)所述呼吸机被配置成在患者进行的吸气过程中通过通气导管向患者提供气体脉冲;
(e)经气管壁假体,其中通气导管同轴安置在经气管壁假体中;其中经气管壁假体和通气导管被安置成使得使用通气设备的患者能够通过患者上呼吸道自由地呼吸;
(f)一或多个呼吸传感器,其被配置成测量患者的呼吸率、肺压力、气道压力或它们的组合,并且确定何时患者进行吸气;以及
(g)呼吸释放装置;其中呼吸释放装置被安置在患者近侧,并且被配置成允许使用通气设备的患者通过所述气管假体向外界呼气,从外界吸气,或进行这二者;其中呼吸释放装置具有打开状态和关闭状态。
6.如权利要求5所述的通气设备,其中,
(h)所述一或多个呼吸传感器被配置成计算患者的正常呼吸率、患者的正常肺压力、患者的正常气道压力或它们的组合;
(i)所述呼吸释放装置被配置成当一或多个呼吸传感器检测出患者呼吸具有正常呼吸率、正常肺压力、正常气道压力或它们的组合时被设置在关闭状态;
(j)所述一或多个呼吸传感器被配置成检测患者的呼吸率偏离正常呼吸率、患者的肺压力偏离正常肺压力、患者的气道压力偏离正常气道压力或它们的组合;
(k)呼吸释放装置被配置成响应于检测到所述偏离而自行打开或被打开。
7.如权利要求5所述的通气设备,进一步包括压力传感器,用于测量肺中的压力,检测肺中的过压,或检测这二者;其中呼吸释放装置包括主动阀。
8.如权利要求5所述的通气设备,其中,呼吸释放装置包括座和隔膜;其中所述阀从肺或从呼吸机接收先导压力信号;并且,利用先导压力信号调节隔膜抵靠着座的位置。
9.一种通气设备,包括:
(a)呼吸机;
(b)气体传输管路,其可操作地连接着呼吸机;
(c)经气管壁假体,其可操作地连接着气体传输管路;其中经气管壁假体被安置成使得使用通气设备的患者能够通过患者上呼吸道自由地呼吸;
(d)所述呼吸机被构造成在患者进行的吸气过程中通过经气管壁假体向患者提供气体脉冲;
(e)一或多个呼吸传感器,其被配置成测量患者的呼吸率、肺压力、气道压力或它们的组合,并且确定何时患者进行吸气;以及
(f)呼吸释放装置;其中呼吸释放装置被安置在患者近侧,并且被构造成允许使用通气设备的患者通过所述气管假体向外界呼气,从外界吸气,或进行这二者。
10.如权利要求9所述的通气设备,其中,
(g)呼吸释放装置具有打开状态和关闭状态;
(h)所述一或多个呼吸传感器被配置成计算患者的正常呼吸率、患者的正常肺压力、患者的正常气道压力或它们的组合;
(i)呼吸释放装置被配置成当所述一或多个呼吸传感器检测出患者呼吸处在正常呼吸率、正常肺压力、正常气道压力或它们的组合时被置于关闭状态;
(j)所述一或多个呼吸传感器被配置成检测患者的呼吸率偏离正常呼吸率,患者的肺压力偏离正常肺压力,患者的气道压力偏离正常气道压力,或它们的组合;以及
(k)呼吸释放装置被配置成响应于检测到所述偏离而自行打开或被打开。
11.如权利要求9所述的通气设备,进一步包括压力传感器,用于测量肺中的压力,检测肺中的过压,或检测这二者;其中呼吸释放装置包括主动阀。
12.如权利要求9所述的通气设备,其中,呼吸释放装置包括座和隔膜;其中所述阀从肺或从呼吸机接收先导压力信号;并且,利用先导压力信号调节隔膜抵靠着座的位置。
13.一种通气设备,包括:
(a)呼吸机,其被配置成:
(i)在患者进行的吸气过程中向患者提供气体脉冲,其中脉冲具有第一气量;以及
(ii)在检测到患者的呼吸停止或呼吸量减小后向患者提供气体脉冲,每个脉冲具有第二气量,其中(1)所述脉冲以正常呼吸率的1-5倍的频率提供,或(2)第二气量为第一气量的25-500%倍,或(3)所述脉冲以正常呼吸率的1-5倍的频率提供且第二气量为第一气量的25-500%倍;
(b)气体传输管路,其可操作地连接着呼吸机;
(c)一或多个呼吸传感器,其被配置成确定何时患者进行吸气,计算患者的正常呼吸量,检测患者的呼吸停止或呼吸量减小;以及
(d)呼吸释放装置,其中呼吸释放装置被构造成允许患者向大气呼气。
14.如权利要求13所述的通气设备,进一步包括压力传感器,其测量肺中的压力,检测肺中的过压,或进行这二者;其中呼吸释放装置包括主动阀。
15.如权利要求13所述的通气设备,其中呼吸释放装置包括座和隔膜;其中所述阀从肺或从呼吸机接收先导压力信号;并且,利用先导压力信号调节隔膜抵靠着座的位置。
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- 2008-09-26 JP JP2010527225A patent/JP5519510B2/ja active Active
- 2008-09-26 CN CN200880117611.7A patent/CN101873875B/zh not_active Expired - Fee Related
- 2008-09-26 EP EP08833948.6A patent/EP2200686A4/en not_active Withdrawn
- 2008-09-26 CA CA2700878A patent/CA2700878C/en not_active Expired - Fee Related
Cited By (8)
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CN102266616A (zh) * | 2010-12-31 | 2011-12-07 | 北京谊安医疗系统股份有限公司 | 一种呼吸设备堵塞的监测方法及装置 |
WO2012089093A1 (zh) * | 2010-12-31 | 2012-07-05 | 北京谊安医疗系统股份有限公司 | 一种呼吸设备堵塞的监测方法及装置 |
CN102266616B (zh) * | 2010-12-31 | 2014-02-26 | 北京谊安医疗系统股份有限公司 | 一种呼吸设备堵塞的监测方法及装置 |
CN104780964A (zh) * | 2012-11-09 | 2015-07-15 | 皇家飞利浦有限公司 | 向对象的气道提供压力脉冲的系统 |
CN103106827A (zh) * | 2013-01-29 | 2013-05-15 | 营口巨成教学科技开发有限公司 | 人工呼吸装置 |
TWI579009B (zh) * | 2014-11-13 | 2017-04-21 | Tni 醫藥股份有限公司 | 用於移動使用的多功能治療器 |
CN109890445A (zh) * | 2016-06-20 | 2019-06-14 | 无限创新公司 | 医用导管安全设备 |
CN113521467A (zh) * | 2021-06-21 | 2021-10-22 | 南昌大学第二附属医院 | 一种具备检测患者苏醒状态的导气装置 |
Also Published As
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US20090151724A1 (en) | 2009-06-18 |
JP2010540119A (ja) | 2010-12-24 |
CA2700878A1 (en) | 2009-04-02 |
EP2200686A1 (en) | 2010-06-30 |
US8567399B2 (en) | 2013-10-29 |
EP2200686A4 (en) | 2017-11-01 |
WO2009042974A1 (en) | 2009-04-02 |
CN101873875B (zh) | 2014-11-12 |
JP5519510B2 (ja) | 2014-06-11 |
CA2700878C (en) | 2018-07-24 |
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