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CN101454041A - 对患者进行呼吸支持的系统、方法和装置 - Google Patents

对患者进行呼吸支持的系统、方法和装置 Download PDF

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CN101454041A
CN101454041A CNA2006800432988A CN200680043298A CN101454041A CN 101454041 A CN101454041 A CN 101454041A CN A2006800432988 A CNA2006800432988 A CN A2006800432988A CN 200680043298 A CN200680043298 A CN 200680043298A CN 101454041 A CN101454041 A CN 101454041A
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L·弗赖塔格
G·卡普斯特
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Abstract

用传感器检测自主呼吸。在吸气过程结束时经喷射气流给肺部施用附加量的氧气。提高了呼吸容积、吸气期间的氧气吸收、以及呼气期间的二氧化碳清除。如果需要，可以暂停或者用逆流减慢患者的呼气过程，以避免呼吸道的塌陷。包括氧泵的装置可以与氧源相连，并包括经导管相连的气管假体。呼吸检测传感器可以与控制单元相连，以启动氧泵。气管假体包括具有导管连接物的管状支持体，以及传感器与支持体相连。气管假体和喷射导管都是合适的尺寸，使得患者可以自由的呼吸和不受限地说话。

Description

对患者进行呼吸支持的系统、方法和装置
优先权要求
本专利申请要求2005年9月20日提交的系列号为No.60/718,318、发明名称为“对患者进行呼吸支持的系统、方法和装置”的美国专利申请的优先权，在此通过引用将其并入本申请。
技术领域
本发明总体上涉及呼吸系统，更具体地涉及用于强化患者通气的专用系统、方法、和装置。
背景技术
如果机体要摄取氧气并排出二氧化碳，那么呼吸气管系统中的两个组分都必须要发挥作用：作为气体交换器官的肺和作为通气器官的呼吸泵，所述呼吸泵将空气转运到肺内，再排出气体。脑部呼吸中枢、中枢神经和外周神经、骨性胸腔和呼吸肌以及通畅稳定的呼吸道对于呼吸泵发挥正确功能都是必需的。
在某些疾病中，存在着呼吸泵的持续超负荷或呼吸泵耗竭。常见的综合征是有着平坦位膈肌(flat-standing diaphragms)的肺气肿。平坦位膈肌没有收缩的能力。在肺气肿中，呼吸道是极为松弛的并有塌陷的倾向。平坦的、过度拉长的膈肌使得患者不能深吸气。另外，塌陷的呼吸道也使得患者不能有效地呼气。这就造成了呼吸功能不全、血液中氧气不足和二氧化碳增多，即通气功能不全。
吸气困难的治疗常常需要呼吸装置。家用呼吸机是一种用于支持或完全代替呼吸泵的人工呼吸器。可以经鼻或口面罩无创性地应用人工呼吸器，患者可以按需佩戴或摘除面罩。但是，鼻或口面罩使得患者不能自由地呼吸和说话，并且是非常有创的。
另一个治疗策略是有创通气。通常经带套囊的气管内插管应用有创通气，所述气管内插管通过口和喉部进入到气管内，或者经气管造口术应用气管内插管。气管造口术包括经手术置入的气管开口。经所述开口将约手指直径的带封闭气囊或套囊的导管插入到气管内，并将其与应用循环正压的呼吸机相连接。该方法使得能够进行有效的深呼吸，但是患者不能说话。
除了经面罩的家用通气和有创通气外，也有通过更细的导管经气管内施用氧气。美国专利No.5,181,509或5,279,288阐述了相应的实施方式。在这种方法中，按经常调节的频率以持续气流的形式给患者施用高剂量的氧气。操作者人工地调节氧气的流速。但是，没有实现对患者的天然呼吸过程的刺激，因为没有增加呼吸深度。与这些经气管导管相关的一些常见问题是对气管敏感内皮(气管黏膜)的激惹和创伤。常见的现象是呼吸运动会造成小导管的尖端碰撞到气管的内壁。除了这种机械性创伤外，高流速的氧气流也会使得周围组织过分干燥。
此外，可以将所谓的“蒙哥马利T管(Montgomery T-tubes)”插入到气管内，患者可以通过其体外的T型管柄获得氧气。如果需要，患者利用吸引管和真空泵可以排出分泌物。当关闭前面的柄部时，患者可以自由地呼吸和说话；但是，通过蒙哥马利T管不可能实现正常的人工正压通气，因为所引入的空气向上逃逸到了口腔或咽部内。上面所提到的治疗的其他局限性是患者活动受限，这是因为通气不足或者是因为装置容积不足。
喷射性呼吸机是现有技术，但是这些装置不能与患者的呼吸同步。另一方面，带套管的有创呼吸机是同步的，因为被动膨胀的肺内压力对呼吸机内的传感器有直接反馈。但是，还没有利用来自机体内的传感器的反馈来正确地同步并控制呼吸机的呼吸系统。
不论呼吸疾病是COPD/肺气肿、纤维化、睡眠障碍等，困难呼吸都是一种严重的、常常致命的问题。因此，存在着对能够提供更为有效的用于支持患者呼吸的方法的呼吸系统的需要，所述呼吸系统可以用于治疗多种疾病，它们是最小有创的、可与患者一起移动和携带的、和/或具有可靠使用性的呼吸系统。此外，需要能刺激患者的自主呼吸且不会不利地影响患者的说话能力的呼吸支持系统。另外，还需要能够利用来自机体内的压力或气流信号来正确地同步并控制呼吸机的呼吸支持系统。
发明内容
本发明包括提高需要呼吸支持的患者的生活质量的系统、方法、和装置。本发明的这些系统、方法、和装置能够通过按需提供额外的氧气来提供更为有效的支持患者呼吸的途径。
在一个实施方式中，本发明的气管假体和导管能够提供可以与患者的自主呼吸同步并仍容许患者说话的呼吸支持。
通过阅读下面的详细描述、附图和权利要求书，本发明的其他特点、优点和实施方式将得到说明或者是显然的。此外，要明白前述的发明内容和下面的具体实施方式都只是举例说明的，以及用于提供更多的解释，并不限定本发明范围。
附图说明
所附附图属于本说明书并构成了本说明书的一部分，用于提供对发明的更多理解，其阐述了本发明的优选的实施方式，并且与具体实施方式一起用于解释本发明的原理。
在附图中：
图1显示了携带有本发明的用于呼吸支持的系统的实施方式的患者的上半身。
图2显示了没有呼吸支持和有本发明的呼吸支持的肺气肿患者的呼吸气流的图解。
图3显示了本发明的气管假体的实施方式的技术简化图。
图4显示了本发明的气管假体的另一个实施方式。
图5显示了本发明的携氧气箱和显示传送气体的泵和控制单元的实施方式的示意图。
图6显示了本发明的导管末端部分的实施方式。
图7显示了被插入到本发明的支持体中的图6的导管。
图8A和8B显示了来自本发明的实验台模型测试的呼吸数据图。
图9显示了本发明的导管和传感器的实施方式。
图10显示了本发明的电路的实施方式的示意图。
图11显示了本发明的导管和传感器的另一个实施方式。
图12显示了本发明的另一个电路的示意图。
图13显示了本发明实施方式的一个系统，其中泵和控制单元与氧气罐整合在一起。
图14显示了本发明的导管远端的实施方式。
图15显示了本发明的导管远端的另一个实施方式。
图16A-16E显示了本发明的导管的实施方式。
图17显示了本发明的双腔导管的实施方式。
图18显示了本发明的在吸气期间流经图17的导管的气流的实施方式。
图19显示了本发明的在呼气期间流经图17的导管的气流的实施方式。
图20显示了本发明的具有可滑动壁的双腔导管的实施方式。
图21显示了不同位置的带可滑动壁的图20的导管。
图22显示了图20的导管的空气出口的放大图。
图23显示了图21的导管的空气出口的放大图。
图24显示了举例说明本发明的实施方式的操作的流程图。
图25是整个系统的示意图。
具体实施方式
在优选的实施方式中，本发明提供了用于支持患者的呼吸的系统、方法和装置。通过提供可控的同步通气以及携氧气体的定向气流可以实现这一点。携氧气体可以是基本上纯的氧气、氧气和氮气的混合物、氧气和惰性气体的混合物、环境空气、或它们的各种组合。另外，携氧气体可以包括香味、雾化药物、或水。优选地根据对患者的自主呼吸的感受，在吸气和/或呼气之后按需提供携氧气体。
如果需要，通过在吸气时提供喷射推进的携氧气体患者可以吸入更多的氧气。优选地，在吸气末特别是在检测到吸气气流的高峰之后施用附加氧气。附加氧气的施用可以提高吸气期间的通气深度。但是，可以在吸气期的任何时间点施用附加氧气。另外，在呼气期间可以传递逆流或逆向脉冲，这就在气道内产生了与物理治疗师采用的缩唇呼吸策略相似的回压，以避免呼吸道的塌陷。通过在呼气末经逆向脉冲提供携氧气体(例如与呼气期气流方向相反的定向携氧气体的脉冲群或脉冲)，可以最小化或避免气道的显著塌陷，可以最小化肺的过度膨胀，以及可以提高肺部二氧化碳的清除。因此，无论本发明是用于吸气和/或呼气，呼吸都只需要更少的耗能并缓解患者的疼痛、呼吸困难和衰竭。此外，本发明的系统和方法可以被用于治疗多种呼吸疾病，包括但不限于COPD、肺气肿、纤维化和睡眠障碍。
参照图1，在本发明的一个实施方式中，患者P代表患有具有呼吸肌过度负荷和衰竭的呼吸疾病例如肺气肿的患者。由于患者的肺是失代偿的，因此患者不能吸入足够多的氧气。另外，患者不能呼出足够多的二氧化碳，因为患者有着松弛和塌陷的呼吸道。图1的系统通常包括检测患者的自主呼吸的能力以及在自主的吸气和/或呼气期间给患者的肺提供氧气的能力。
如图所示，本发明的患者P的呼吸支持可以被应用于本发明的系统、方法、或紧凑的和/或可移动的装置中。也包括其他系统，只要它们能与如图13所示的呼吸机或氧源一起使用。图25描述了本发明的整个系统，包括氧源O2、泵装置1和控制系统12、导管5和内传感器8、9和患者P。氧源O2、泵装置1和控制系统12可以是分离的或整合的系统组分。控制单元12可以与内传感器8、9和/或外传感器13、14相连。
在图1的实施方式中，可以通过传感器的方式检测到患者P的自主呼吸。可以按需用导管5将氧气引入到肺内。可以用多种方式将传感器和导管与患者相连接。如图1所示，将导管5引入到气管内。也可以在其他部位将导管5引入到患者体内，包括通过患者的口部或鼻部，或者通过在人体其他部分人工生成的入口点进入到气管内以及经内在通道进入到气管内。可以通过多种方式将导管5固定在气管上。在一个实施方式中，导管可以与后面所讨论的气管假体相连或者也如后面所讨论的使用定向导管，例如参照图3和4。
图1的系统一般包括携氧气源(未显示)、气泵1、可移动的呼吸装置4、一组外传感器13、14、和一组安置于患者P的气管内的内传感器(未显示)。携氧气泵1可以与气源(见图5)和导管5相连接，以便通过气管向患者的肺部引入携氧气体，不过也可以使用如上讨论的本发明的其他入口点。如图1所示，携氧气泵1是紧凑的、容易移动的呼吸装置4的一个组分。如图13所示，装置4还可以与气箱或携氧气源安置于一个组分上。通过本发明的传感器可以检测到患者的自主呼吸。来自传感器的信息通常可以被传送到气泵1。但是，来自传感器的信息也可以被传送到手机或其他无线系统中，所述无线系统可以将信息传送到医疗保健人员/医院等并接受来自医疗保健人员/医院的应答，以便进行24小时监测。然后患者可以按需接受到本发明的携氧气体的压力推进。图2描述了患者P在没有本发明的呼吸支持(右侧)和有本发明的呼吸支持(左侧)时的自主呼吸。该图中的x轴代表时间，y轴代表携氧气体的流量(容积随时间的变化)，所述流量可以是升/秒或任何其他合适的检测单位。图2的左半部分显示了患者P在没有呼吸支持时的包括吸气流量和呼气流量的自主呼吸过程。吸气曲线用E1表示，呼气曲线用A1表示。如曲线E1所示，在吸气期间吸入的潮气量要比正常患者的潮气量小。例如，患有平坦膈肌的肺气肿患者或患有纤维化的硬肺患者都不能在一次呼吸中呼吸足够多的空气(氧气)。两种患者通常都进行浅呼吸。因此，患者需要更多的呼吸周期，以便获得所需量的氧气并清除二氧化碳。如曲线A1所示，在呼气期间，肺气肿患者的呼气流量是减少的，因为呼吸道是松弛的，并且呼吸道会在能够从肺部排出足够量的二氧化碳之前发生塌陷。
传感器容许连续地监测患者P的呼吸，使得可以在需要深呼吸时应用本发明的携氧气体的喷射气流。具体地，在肺的吸气过程结束时，可以给患者P施用附加容积的气体(氧气)，下面将会有更详细的谈论。图2的右半部分描述了这个呼吸气流。如图所示，提供给患者P的附加量的携氧气体增加了患者在曲线E2所示的吸气期间的呼吸容积，容积差异用上方曲线中加深颜色部分表示，并称作E3。附加量的携氧气体可以具有额外量的潮气量，在25和150ml之间。
另外，可以用逆流使得患者的呼气过程制动或减慢。因此，呼气期间的呼吸气流沿着用A2表示的曲线移动。这种作用于呼气相反方向的有目的的阻力避免了呼吸道在呼气期间的塌陷。因此，也可以增加呼气容积，所述容积也用加深的颜色部分表示，并被称作A3。可以增加呼出的二氧化碳的量，所述量是有统计学显著差异的量。呼出的二氧化碳的量至少可以增加5％。优选地，呼出的二氧化碳的量增加了5％到30％。更优选地，呼出的二氧化碳的量增加了约20％到30％。
因此，本发明可以避免无效呼吸造成的供氧不足和血液中二氧化碳的增加。患者P明显可以面临更少的应激并可进行更多的活动，以及可以更少有气短或没有气短的感觉。
现在将更详细地讨论用于检测和监测呼吸的传感器。为了检测到患者P的自主呼吸，传感器可以与位于患者P的气管内的导管末端相连接。在一个实施方式中，本发明可以包括导管和气管假体的连接(见图3、4和7)或者可以包括导管定位装置(例如图14、15和16A-16E)，以便更可靠地和更准确地将氧气流导入到患者的气道内并远离气管壁。优选地，在本发明中，按照患者可以自由呼吸和不受限的说话的方式将氧气引入到患者P体内。
在一个实施方式中，如图3和4所示，传感器可以位于气管假体2、3上。显示了每个假体2、3，其具有管状支持体6和与导管5的接头7。如图所示，两个传感器8、9检测患者P的自主呼吸，以及可以与支持体6相连。传感器8、9可以是热敏电阻器即温度依赖性电阻器。传感器8、9可以检测出患者的气管气流，因为吸入的空气和呼出的空气具有不同的温度。热敏电阻器8、9可以被一起连接到装置上的桥式电路上，以补偿环境空气温度的变化。本发明也可以使用其他类型的传感器，包括例如如后面讨论的压力传感器。两个传感器8、9都可以位于支持体6的内壁10上(图3)或者一个传感器8可以固定于支持体6的内壁10上，另一个传感器9可以位于支持体6的外壁11上(图4)。传感器8、9与控制单位12相联通，用于启动氧气喷射泵1。可以通过有线或无线通讯连接传感器8、9。控制单位12可以是任何类型的能够处理本发明所收集到的数据的微处理器。图5概括地显示了控制单元12，其具有输入端(I)和输出端(O)。输入端(I)代表来自传感器的信息。输出端(O)代表用于控制泵1的信息。
在图3的气管假体2中，通过接头7可以将喷射导管5插入到支持体6内。位于支持体6内的喷射导管5的末端15优选地被导向或偏向为接近平行于支持体纵轴L的方向。从传感器8、9到控制单元12的数据线位于导管5内。本发明并不限于数据线；来自传感器的传输可以是任何类型的传输包括无线传输。在排出口侧，喷射导管5的末端15优选地被设计成喷射喷口25。喷射喷口25增加了从导管5内排出的氧气流的流速，并且沿着气道的方向运行氧气流。支持体6的直径被设计成具有足够游离的管腔的尺寸，使得患者P可以自由呼吸和说话，甚至当整合有导管5时也是如此。
在另一个实施方式中，如图4所示，在气管假体3的接头7上提供了一个分离的连接器18。导管5可以通过分离的连接器18与气管假体3相连。在这种情况中，与纵轴L平行对齐的固定的纵切面19可以作为支持体6内的导管末端，以及通过喷射喷口26实现气道方向上的氧气流。
所用的气管假体可以包括不同的构型、形状和尺寸。例如，管子可以是T型或L型等。尺寸、形状、和/或横截面可以有所不同，以便用于拔除或定位导管。器官假体可以是具有例如半圆型横截面的管子的一部分。此外，可以在气管开口处使用可膨胀的和可自膨胀的叉状物(prongs)或翼瓣(petals)，以便将假体固定在其位置上。在一个实施方式中，假体可以包括具有气管侧开口的管状部件，其包括整个或部分围绕在入口的叉状物或翼瓣。叉状物或翼瓣可以像铆钉一样在颈部开口处发挥作用。气管假体也可以具有涂层，以避免粘液滞留，防止肉芽组织的形成，或者可以作用为药物释放装置。气管假体也可以包括其他的涂层例如光滑涂层和水凝胶麻醉剂。因此，气管假体可以作为导管的导向物，作用于把持感受装置，作用为药物转运装置，和/或使得可以在导管尖端形成的粘液栓最小化。
除了内传感器外，可以提供外传感器。图1也显示了呼吸传感器13、14，优选地是阻抗电极或Respiband。来自传感器13、14的信号也可以用于检测患者P的自主呼吸作用。通过处理经传感器8、9和13、14接受到的测量值可以获得患者P的呼吸过程的准确图像。另外，由于传感器的冗余，可能增加安全性以消除传感器8、9和/或13、14其中之一的假性测量值或测量失败所带来的影响。尽管显示出传感器位于患者P的特定部位，但是可以使用容许传感器直接或间接地感受到患者的呼吸的其他部位。例如，如下文讨论的那样，可以提供位于导管上的传感器。同样，可以使用和/或植入弹丸型传感器或纳米装置，其与控制单元无线传输通讯，以便操纵流经本发明的导管的氧气流。
图6显示了其中提供了位于导管上的传感器的实施方式。图6显示了导管28，其具有长的、可曲的管子29和以一定曲率30弯曲的排出口侧的末端31。导管28可以被预先制备成能够提供所需的曲率30。提供合适的曲率30，导管28可以进入到有或没有使用假体的气管内。在这个实施方式中，用于检测患者P的自主呼吸的两个传感器32、33可以被固定在导管28的末端。传感器32、33优选地是热敏电阻器，但是在此的所有实施方式中，其都可以是其他类型的传感器。此外，在本发明的其他实施方式中，可以使用附加传感器。仍在本发明的其他实施方式中，可以使用更少的传感器。为了简单性的原因，在图中没有显示出数据线，可以包括任何形式的数据传输。在硬线的实施方式中，数据线可以铺设在导管28内。导管边缘34设计出了用于支持体36的挡块，如图7所示。这也可以见于提供有喷射喷口35的导管28的末端31。在喷射喷口35中，气流的横截面要小于导管28的横截面，使得增加了所供应的氧气的排出速度。
如图7所示，导管28可以被引入到支持体36内。支持体36位于患者P的气管内。通过接口37实现与外界的连接。在这个支持体中，导管28的尖端或喷射喷口末端35可以位于气管内。优选地，导管28的尖端不会碰到气管壁。支持体36可以是常用的蒙哥马利T支架。
图8A和8B显示出了模拟呼吸疾病的肺部模型中的测量值。图8A和8B图解说明了本发明增加的潮气量。图8A显示了呼吸容积的条线图，其比较了肺气肿患者病理性低呼吸的容积约为90ml；吸气时使用本发明的喷射氧气时的容积约为260ml；而吸气时使用本发明的喷射氧气和呼气时使用气流制动(氧气喷射)时的容积约为300ml。图8B显示了关于肺气肿患者的呼吸气流(升/秒)随时间变化的图；吸气时使用本发明的喷射氧气时的气流；和吸气时使用本发明的喷射氧气和呼气时使用气流制动(氧气喷射)时的气流。
在如图9和10所示的另一个实施方式中，热敏电阻器81和82可以位于气管内的导管尖端上。热敏电阻器81比热敏电阻器82更多地暴露于气流，由于其位于导管壁的内部(或在保护膜下面)，这就保护其避免快速的温度变化。同样，可以使用具有不同应答时间的多个热敏电阻器。在更长的时间内(例如10秒钟)，两个平均温度是相同的(平衡的)，并且可以重新调整桥接(图10)。这就补偿了环境温度的变化、发热等。热敏电阻器81可以检测出基于吸入更冷的空气和呼出更暖的空气的快速变化。通过微分电路发出输出信号。热敏电阻器信号的高峰对应于最高流速。可区分信号中的最小值对应于吸气气流峰值和呼气气流峰值。将不可区分和可区分的信号都输入到微处理器内。确定吸气气流峰值(开始引入氧气的触发点)的一个方法是寻找绝对温度的最低值(吸入冷空气)和温度的零变化(微分信号为0)。使用上面的多个热敏电阻器方法的有点是来自两个热敏电阻器的信号之间的差异抵偿了在所测定到的呼吸气流模式中发现的例如由振动或其他预期事件引起的气流假象，以及补偿了例如由改变外面的或内在的温度或湿度条件引起的热敏电阻器信号的漂移。
在如图11和12所示的另一个实施方式中，图11显示了压力传感器，其是一个经改良的硅胶线应变仪(silicone wire strain gauge)元件90。用导管壁取代了常用的硅酮膜。如果在气管内的压力冲击(呼吸运动)下造成了导管壁变形，那么来自桥式放大器的电信号就被输入到微处理器内。该实施方式同样可以用于热敏电阻器，作为冗余信号或储存信号。其他传感器可以是半导体气流传感器或压力传感器。图12显示了桥式放大器的电路图。
其他的传感器也可以用于本发明。例如传感器和/或次级控制传感器可以是：Respiband(胸壁牵拉测量仪)、Respitrace信号(气传导容积描记图)、机体内或外的压力传感器、经胸腔的电阻抗测定装置、口腔或鼻部的气流传感器(呼吸速率仪)和/或二氧化碳监测仪(二氧化碳传感器)。此外，本发明的传感器可以通过任一装置、机制或方法将数据或信息传输到控制单元。例如，通过有线、无线或遥控传送都可以实现传输。利用非热敏电阻器传感器的优点是热敏电阻器可能具有在其头部聚集气道粘液的缺点，多种方法例如清洗可以纠正这个缺点。但是，其他非热敏电阻器传感器可能不容易遇到例如粘液聚集这样的烦扰。此外，对于热敏电阻器传感器而言，虽然在热敏电阻器信号处理算法中进行了补偿，但是环境温度不可避免的变化对于系统可靠性都是潜在的问题。因此，上面给出的其他类型的传感器可能优于热敏电阻器传感器或者可以是除热敏电阻器传感器外的其他有用的传感器。
除了测定呼吸模式外，因为安全的因素常常还需要测定气道压力，热敏电阻器传感器对此可能不是最好的方法。因此，上面提及的一些传感器也可以用作安全控制装置。例如，可以用压力传感器感知患者的吸气(和热敏电阻器一样)，但是它们也可以用于感知气管内的高压力并关闭喷射机器，以避免气压伤(高压引起的损伤)。
按需用气泵1提供携氧气体。图5图解显示了气泵1。气泵1可以是具有位于气缸27内的双向作用活塞20的活塞泵。本实施方式的活塞泵包括4个阀门V1到V4。其他活塞泵(未显示)可能具有超过或不足4个阀门。经过连接物21从外在氧气箱中提供氧气供应。用字母a到g表示阀门V1到V4的开关状态和供应管路和排出管路。本发明可以使用其他类型的泵。
在呼吸支持过程中，气泵如下所示在装置中发挥作用。当阀门V1从c到a开放(b到c关闭)以及阀门V2从b到e开放(e到d关闭)时，活塞20移动到图面的左侧，氧气经出口22和喷射导管5流入到患者P体内。在患者P的吸气过程中施用了附加量的氧气E3。
当阀门V1从b到c开放(c到a关闭)以及阀门V2从e到d开放(b到e关闭)时，活塞20移动到图面的右侧，在阀门V3的方向上形成氧气流。阀门V3经出口23与周围空气相通。在其中阀门从d到g开放的情况中，氧气流关闭且没有呼气制动。这意味着逆流没有制动住呼气过程。
如果阀门V3从d到g关闭以及从d到f开放时，氧气流经出口22和导管5方向上的流入通路24，以便在呼气过程中被施用到患者P体内以及制动呼气气流。逆流避免了呼吸道的塌陷并保持呼吸道开放，使得更深的呼气成为可能。
此外，阀门V4位于装置的流入通路24上，可以可变地调节流经通路24的气流(f到a)。这优选地是具有脉冲宽度调制的定量阀。
如上讨论的一样，导管优选地包括喷射喷口。可以用任何类型的喷射喷口实现必需的喷射气流。本发明的喷射气流速度可以显著地高于100m/s。而通过传统呼吸机管路或面罩的气流速度要明显小于100m/s。当喷射流速足够高时，足够高的速度使得能够实现定向气流，密封的管路袖套可能不是必需的。在正常通气中，经容积测定到的吸气流速范围是从2秒内约500m3到1000cm3。峰值吸气流速的最大值可以是1000cm3/秒。在正常的侵入性通气中，1000cm3/秒(峰值)的气流流经约8mm直径的管路。通过用经容积测定的吸气流速除以管道的横截面面积所测定到的该气流流速是1000cm3/(0.4)2cm2*Pi＝2000cm/s＝20m/s。在喷射通气期间，该气流的近一半气流流经1.5mm直径的喷射套管。当流速图形为矩形时，峰值流速为500cm3/s。因此，喷射气流的速度为500cm3/(0.075)2cm2*Pi＝28313cm/s＝283m/s。根据本发明优选的实施方式，另一半气流约100ml(cm3)经加压流经约1.5mm直径的导管。该实施方式中的峰流速优选地是0.25秒内100cm3＝400cm3/s。该气流的速度为400cm3/(0.075)2cm2*Pi＝22650cm/s＝226m/s。在其他优选的实施方式中，气流速度是从近100m/s到近300m/s。优选地，气流速度是从近200m/s到近300m/s。优选地，气流速度是从近250m/s到近300m/s。
当导管尖端触及气管壁时，就存在组织损伤的潜在危险。导管尖端或高流速气流都会损伤粘膜。为了在机体内有效地和有力地定向气流，导管可以被配置成能够提供定向的氧气流。具体地，优选地配置导管，使得可以从导管输出端排出空气以及指导空气沿着导管中心下行，以避免氧气喷射气流直接地冲击气管壁。也优选地配置导管尖端，使得文丘里管(venturi)和导管外壁上的接近文丘里管处的粘液形成最小化。可以用上面所述的带防护的蒙哥马利T管来克服这个问题。在图14和15中，导管被配置成导管尖端或喷射喷口不与气道壁接触，尖端基本上都在气管的中央。通过配置导管可以使得导管在多个位置与气管壁接触，以便分散局部压力，其中尖端排出氧气的喷射气流的导管基本上都在气管的中央。因此，并不必须要使用气管假体。避免尖端(喷射喷口)和气道壁之间的接触的一个方法是在两个平面上将导管弯曲成Z字形，如图14所示。另一个实施方式是如图15所示的螺旋形。
图16A-16E显示了用于将导管定位于中心的实施方式，其中用球囊(图16A和16B)或夹子(图16C到16E)将导管尖端定位于中心。图16A显示了用于将导管尖端定位于中心的球囊，其中球囊具有经线路J-J的大致圆形的横截面。球囊开口可以位于导管的纵轴方向。图16B显示了用于将导管尖端定位于中心的球囊，其中球囊可以具有多个延伸物。延伸物可以表现为沿导管纵轴方向上的横截面为K-K的锥形突起。图16C显示了从导管放射性延伸出去的夹子。该实施方式中的夹子是相当平坦的，以及相对成对的延伸出去。图16D显示了在夹子末端具有延伸物的夹子的另一个实施方式。夹子和延伸物可以在相对于导管的多个方向上延伸开，用于将导管尖端定位于气管中央。图16E显示了具有沿导管长径上的多个位置上的成型突起的夹子的另一个实施方式。突起可以具有扁平顶部和圆形边缘及底切。优选地，各种实施方式的夹子是由弹性材料制成的。
现在参照图17到23来描述双腔导管。本发明也可以包括更好地分布定向气流(图17-19)和/或改变气流方向(图20-23)的能力。图17-19显示了双腔导管172。用170所示的导管尖端位于气管174内。导管172具有两个腔，是由内套管176和外套管178组成的。内套管176将气流定向到导管喷口180，如上讨论的那样。如图18所示，在吸气之后，通过来自流经内套管的喷射气流的空气夹带(air entrainment)加上附加的喷射气流本身176可以增强吸气气流。在呼气之后(图19)，通过来自通过推进呼吸道开口方式的经出口182的逆向气流的湍流可以增强呼气气流。出口182不必是任何特殊的形状，可以使例如圆形、六边形、椭圆形、或裂缝。尽管没有显示，根据所需的作用，也可以通过内套管176提供呼气期间的湍流。
参照图20-23显示了导管的另一个实施方式。显示了位于气管204内的具有远端尖端202的导管200。导管202包括具有内腔206、与内腔同中心的外腔208、和滑动鞘管210的套管构造。在这个实施方式中，滑动鞘管210相对于套管移动，以便容许出口210改变氧气气流的方向，如图20对图21和图22对图23中的特写所示。如图22所示，在呼气之后，通过滑动鞘管210的移动引起的气流制动湍流可以生成例如缩唇呼吸中的阻力，这可以支撑呼吸道开放，以便增加呼出气体的量。或者，如图23所示，向口部加入经滑动鞘管210的移动所引起的文丘里管气流可以产生呼出气流，以便增加总的呼气容积。虽然只显示出滑动鞘管是可移动的，但是多个部分或其他部分也可以被制成为可移动的，以便完成本实施方式的定向气流。例如，也可以用闸门、百叶、或挡板产生气流制动湍流或朝向口部的文丘里管气流。
无论如何，气流可以被按需定向到口部或者定向到肺内。用于患者呼气气流的气流制动可以从湍流(缩唇效应)调整到增益(Venturi原理)。整个导管的外径优选地不超过4cm，但是可以是非常多能的。与本发明的其他实施方式一样，本实施方式也可以用于将振动气流应用到呼吸道，以提高粘液的清除。
本发明的系统可以是可植入的。在一个实施方式中，包括喷射导管和系统传感器的系统可以被植入到体内。虽然可以植入泵，但是与泵相连的管子可以与保留在体外的连接器相连接。可以通过传统方式连接泵管和连接器，使得携氧气体流经所植入的喷射导管进入到本发明的患者体内。可以根据患者的需要定制系统。根据患者的呼吸条件和一般状况，可以按需地监测、控制和调整脉冲的喷射压力和时机及持续时间。如图1所示，导管可以沿体外延伸。或者，导管可以被植入到患者的体内。例如，导管可以具有一个用于连接泵的暴露末端以及导管剩余部分中的一部分或所有部分都可以被植入到患者体内和/或患者的皮肤下。暴露出导管的输出末端，用于连接气管假体或者定位于鼻或口。此外，可以处理位于患者体内的导管部分。例如，可以用抗菌素、药物、光滑涂层、预防粘液形成的处理等处理导管。
图24是说明发明方法的实施方式的流程图。根据发明的这个实施方式，给患者提供了本发明的系统。系统被用于检测患者的自主呼吸。在吸气气流的峰值处或附近，系统确定出患者是否需要附加的氧气。如果需要，系统给患者提供氧气的喷射推进。然后在呼气气流的峰值处或附近，系统确定出患者是否必须要呼出更多的二氧化碳。如果必须要呼出更多的二氧化碳，那么系统给患者提供逆流氧气。按需重复本过程。本实施方式的优点是容许治疗与患者的需求相匹配。而其他的呼吸机系统会给患者应用预先设定的治疗，不论患者的条件如何变化，除非临床医生改变了呼吸机的设置。其他的呼吸机系统对于多数患者状态而言都是治疗亚最佳的，常常造成过度治疗，使得患者过分依赖于人工通气，或者造成治疗不足，因此恶化了患者的临床状况。因此，本发明的呼吸机将根据患者的需求调整输出给患者的输出量。呼吸机可以通过使用经传感器已经获得的患者信息例如呼吸速度、呼吸深度、吸气或呼气长度、兴奋、或气体浓度水平进行判定。例如，如果患者正在运动，传感器检测到了非常低的呼气流速，这说明气道在呼气期间塌陷太多，那么就可以打开或增加呼气逆流，以便支持气道开放并增加呼气气流。或者，例如，如果经呼吸传感器测定到患者的呼吸变得非常的快，说明患者正在代偿呼吸急促，那么就可以打开或增加吸气增强脉冲，以便缓解患者的呼吸困难。或者在另一个实施例中，检测气道内CO2和O2水平的气体组分传感器可以确定出治疗是否是充分的，以及按需增加或减弱治疗。
如上提及的那样，可以用本发明的原理治疗和/或辅助治疗各种呼吸疾病和/或呼吸困难。在这些治疗中，本发明向患者的所有气道内都提供了携氧气体。在一个这种实施方式中，例如利用导管以及更具体地利用气管或涂层导管将携氧气体定向到上气道内，而不是将其定向到肺内。
在一个实施方式中，携氧气体可以被定向到上气道内，以便治疗或辅助治疗睡眠呼吸暂停。睡眠呼吸暂停是一种严重的睡眠疾病，当患者的呼吸在其睡眠期间经常性地受到中断时就发生了睡眠呼吸暂停。未经治疗的睡眠呼吸暂停患者在其睡眠期间经常性地停止呼吸，有时候在夜间有数百次类似发作。一种类型的睡眠呼吸暂停被称作阻塞性睡眠呼吸暂停(OSA)。OSA是由气道阻塞引起的，常常是因为咽后壁上的软组织在睡眠期间塌陷。现在可以用持续气道正压通气(CPAP)治疗睡眠呼吸暂停，其中患者可以带上鼻部和/或口部的面罩。吹风机强迫空气流经上气道。调整气压，使得其足以克服上气道组织在睡眠期间发生塌陷。所述压力是恒定的和持续的，根据需要有时可以用双水平气道正压(BiPAP)机器调整流速。CPAP虽然在其应用时可以阻止气道关闭，但是当CPAP停止或者其被不正确使用时，呼吸暂停发作会重复出现。鼻面罩以及经口输送气体/氧气/环境空气的应用十分麻烦，并限制了患者的活动。相反地，在本发明中，可以通过导管包括气管导管的方式给患者提供携氧气体。可以依据本发明的传感器所监测到的呼吸给患者提供携氧气体。这包括放置于上气道组织内用于感受组织运动或塌陷的传感器。这些传感器可以通过无线或有线的方式与泵相沟通。传感器可以检测呼吸周期，并据此信息来控制氧流和容积。可以按需持续地、间断地或脉冲地提供携氧气体。或者，如上讨论的那样，可以提供喷射气流的携氧气体。此外，可以给移动式呼吸设备设定程序，使得可以传送持续的携氧气体气流，只在需要时才启动喷射推进。因此，可以依据患者的需要给予氧气。
本发明可以用于治疗各种肺泡通气和氧气摄取异常的疾病。这包括慢性阻塞性气道肺病包括肺气肿、以及限制性肺病例如肺间质纤维化、结节病、胸膜粘连、胸部疾病、神经肌肉疾病、和膈神经麻痹。基本上只要患者存在呼吸深度不足的问题，本发明就有帮助。
与本发明不同的是，常用的有创通气是以持续方式提供的，而患者根本不能活动(行走、提取物品等)。患者的咽腔有插管，并被固定到床上(一般都是在重症监护病房)。有时候提供带面罩的无创通气，以便有助于患者虚弱的呼吸肌恢复功能。例如，如果患者在夜间接受通气，那么膈肌和辅助肌肉都可以休息，患者可以在白天更好的工作。但是，每当患者需要最多帮助时(在运动期间)，患者必须要靠自己呼吸。利用来自本发明系统中的最小有创通气或经皮通气以及同步喷射可以按需给予支持(例如在运动期间)。
尽管上面的描述涉及的是本发明的优选的实施方式，要注意的是其他的变化和改进对于本领域熟练人员都是显然的，且没有脱离本发明的精神或范围。此外，结合本发明的一个实施方式描述的特性也可以联合用于其他实施方式，尽管上面没有明确的指出。可以用不脱离本发明的精神或基本特征的其他特殊方式阐述本发明。所述的实施方式在所有部分都只是描述性的而不是限制性的。本发明的范围因此是由附录的权利要求书规定的而不是前面的描述所规定的。在权利要求书的等效物的意义和范围内的所有变化都包含在其范围之内。

Claims (61)

1.用于支持患者呼吸的装置，包括：
与携氧气体源可操纵地连接的气泵；
用于启动气泵的控制单元；
受控制单元控制的用于检测患者的自主呼吸的传感器；和
用于插入到患者的呼吸系统内的导管，其与携氧气体输送装置以流体连通方式相连接。
2.权利要求1的装置，其中传感器包括热敏电阻器、压力传感器、硅胶线应变仪、Respiband、Respitrace、经胸电阻抗测定装置、口部或鼻部气流传感器、或二氧化碳监测仪。
3.权利要求1的装置，其中传感器与控制单元无线相连接。
4.权利要求1的装置，其中导管与气管内的气管假体相连接。
5.权利要求4的装置，其中气管假体还包括叉状物或翼瓣。
6.权利要求4的装置，其中气管假体还包括抗菌素、药物、光滑涂层、水凝胶麻醉剂、预防肉芽组织形成的处理、或预防粘液形成涂层的处理。
7.权利要求1的装置，其中导管还包括喷射喷口。
8.权利要求7的装置，其中通过使用导管中与气管壁相接触的螺旋或弯曲而使得导管的出口部分基本上位于气管的中央。
9.权利要求7的装置，其中导管还包括夹子或球囊。
10.权利要求9的装置，其中导管具有单个环状球囊或多个球囊。
11.权利要求9的装置，其中夹子由弹性材料制成。
12.权利要求1的装置，其中导管包括内腔和外腔。
13.权利要求12的装置，其中外腔壁包括多个孔。
14.权利要求13的装置，其中所述多个孔基本上都是圆形的、六边形的、卵圆形的、或裂口形的。
15.权利要求13的装置，其中导管还包括用于调节流经所述孔的携氧气体气流的气流调节器。
16.权利要求15的装置，其中气流调节器包括滑动鞘管、闸门、百叶、或挡板。
17.权利要求1的装置还包括呼吸机。
18.权利要求1的装置，其中至少一个纳米装置传感器被植入到患者的体内。
19.权利要求1的装置，其中来自携氧气源的携氧气体还包括香味、雾化药物、或水。
20.权利要求19的装置，其中携氧气体是经加热的。
21.权利要求1的装置，其中控制单位被程序化，使得呼吸装置可以施用来自携氧气源的持续的携氧气体气流，而只在需要时才启动喷射推进。
22.权利要求1的装置，其中传感器被放置于不同的位置。
23.权利要求22的装置，其中传感器的信号应答相对于附加传感器的信号应答而被衰减，其中比较所述传感器的信号应答和附加传感器的信号应答，以便校正信号漂移、瞬时信号和假象。
24.权利要求1的装置，其中气泵、携氧气源和控制单元被放置在一起。
25.用于支持患者呼吸的方法，包括以下步骤：
将导管插入到患者的呼吸系统内，且不妨碍患者的说话能力；
用传感器检测患者的自主呼吸；
鉴定出吸气过程的终点；
给肺部施用附加量的携氧气体，且不妨碍患者的说话能力。
26.权利要求25的方法，其中连续地、间断地、或脉冲地施用携氧气体。
27.权利要求25的方法，其中传感器包括热敏电阻器、压力传感器、硅胶线应变仪、Respiband、Respitrace、经胸电阻抗测定装置、口部或鼻部气流传感器、或二氧化碳测定仪。
28.权利要求25的方法，其中导管与气管内的气管假体相连接。
29.权利要求28的方法，其中气管假体被叉状物或翼瓣将固定在气管内。
30.权利要求28的方法，还包括通过提供有涂层的气管假体而给患者应用抗菌素、药物、光滑涂层、水凝胶麻醉剂、预防肉芽组织形成的处理、或预防粘液形成的处理。
31.权利要求25的方法，其中导管包括出口，其中导管的出口基本上位于患者气管的中央。
32.权利要求31的方法，其中通过使用导管中与气管壁相接触的螺旋或弯曲而使得导管的出口基本上定位于气管的中央。
33.权利要求31的方法，其中通过使用与导管相连的夹子或球囊将导管的出口基本上定位于气管的中央。
34.权利要求33的方法，其中导管具有单个环状球囊或多个球囊。
35.权利要求33的方法，其中夹子由弹性材料制成。
36.权利要求25的方法，其中经口部或鼻部将导管引入到患者的呼吸系统内。
37.权利要求25的方法，其中导管包括外腔和内腔，且其中外腔的壁包括多个孔。
38.权利要求37的方法，还包括在吸气期间经内腔施用携氧气体以及在呼气期间经外腔使用携氧气体。
39.权利要求25的方法，还包括应用振动气流，以提高对粘液的清除。
40.权利要求25的方法，还包括感受气管内的高压并关闭携氧气体的施用。
41.权利要求25的方法，其中携氧气体基本上包括纯氧、氧气和氮气的混合物、氧气和惰性气体的混合物、环境空气以及其各种组合。
42.权利要求41的方法，其中携氧气体还包括香味、雾化药物、或水。
43.权利要求41的方法，其中携氧气体是经加热的。
44.权利要求25的方法，其中控制单元被程序化，使得携氧气体输送装置施用持续的携氧气体，而只在需要时才启动喷射推进。
45.气管假体，其包括：
管状支持体，
喷射导管的接头，
至少两个与管状支持体相连接的传感器，
其中传感器包括热敏电阻器、压力传感器、硅胶线应变仪、经胸电阻抗测定装置、气流传感器、或二氧化碳测定仪。
46.权利要求45的气管假体，其中通过将其中一个传感器包埋于管状支持体内或者包埋于保护膜下来补偿桥式电路。
47.权利要求46的气管假体，其中通过使用具有不同应答时间的传感器来补偿桥式电路。
48.权利要求45的气管假体，还包括导管，所述导管还包括内腔和外腔。
49.权利要求48的气管假体，其中导管外腔的壁包括多个孔。
50.权利要求49的气管假体，其中所述多个孔基本上是环状的、六边形的、卵圆形的、或裂孔形的。
51.权利要求50的气管假体，其中导管还包括用于调节流经所述孔的氧气气流的气流调节器。
52.权利要求51的气管假体，其中气流调节器包括滑动鞘管、闸门、百叶、或挡板。
53.用于呼吸支持的双腔导管，其包括：
内腔和外腔，
其中给内腔的末端具有喷射喷口以及外腔的壁包括多个孔。
54.权利要求53的双腔导管，其中所述多个孔基本上是环状的、六边形的、卵圆形的、或裂孔形的。
55.权利要求54的双腔导管，其中导管还包括用于调节流经所述孔的氧气气流的气流调节器。
56.权利要求55的双腔导管，其中气流调节器包括滑动鞘管、闸门、百叶、或挡板。
57.权利要求56的双腔导管，还包括至少第一个传感器。
58.权利要求57的双腔导管，还包括第二个传感器。
59.权利要求58的双腔导管，其中第一个和第二个传感器是热敏电阻器、压力传感器、硅胶线应变仪、经胸电阻抗测定装置、气流传感器、或二氧化碳测定仪。
60.用于支持患者呼吸的方法，包括以下步骤：
将携氧气体输送装置插入到患者的呼吸系统内，
用传感器检测患者的自主呼吸，
鉴定出吸气相和呼气相，
在吸气期间给肺部施用附加量的携氧气体以加强吸气和/或在呼气期间给肺部施用附加量的携氧气体以加强呼气，和
其中根据传感器的反馈来增加、降低、打开或关闭携氧气体的施用。
61.用于支持患者呼吸的装置，包括步骤：
用于检测患者的自主呼吸和鉴定吸气相和呼气相的传感器，
用于插入到患者的呼吸系统内的携氧气体输送装置，
与所述传感器相连的用于在吸气期间给肺部施用附加量的携氧气体以加强吸气和/或在呼气期间给肺部施用附加量的携氧气体以加强呼气的控制单元，和
其中根据传感器的反馈来增加、降低、打开或关闭携氧气体的施用。
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US20090255533A1 (en) 2009-10-15
WO2007035804A2 (en) 2007-03-29
US20100269834A1 (en) 2010-10-28
EP1926517A2 (en) 2008-06-04
CN101454041B (zh) 2012-12-12
US8418694B2 (en) 2013-04-16
CA2623756A1 (en) 2007-03-29
JP2009508645A (ja) 2009-03-05

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