CN110505900A - 用于通过改善患者的射血分数来治疗心力衰竭的方法 - Google Patents

用于通过改善患者的射血分数来治疗心力衰竭的方法 Download PDF

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Publication number
CN110505900A
CN110505900A CN201880023847.8A CN201880023847A CN110505900A CN 110505900 A CN110505900 A CN 110505900A CN 201880023847 A CN201880023847 A CN 201880023847A CN 110505900 A CN110505900 A CN 110505900A
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China
Prior art keywords
patient
ejection fraction
pulmonary
nerve
blood
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CN201880023847.8A
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Inventor
欧尔·沙比泰
达利特·沙夫
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Sony Weiye Co Ltd
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Sony Weiye Co Ltd
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Priority to CN202310609278.8A priority Critical patent/CN116570847A/zh
Publication of CN110505900A publication Critical patent/CN110505900A/zh
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Abstract

一种用于改善有此需要的患者的射血分数的方法，所述方法包括：将肺动脉操纵装置定位在所述患者的肺脉管系统内的目标血管中；和使用所述肺动脉操纵装置削弱至少一个交感神经、神经纤维或神经元的活动以将所述目标血管去神经支配，从而改善所述患者的射血分数。

Description

用于通过改善患者的射血分数来治疗心力衰竭的方法
技术领域
本公开内容总体上涉及肺动脉去神经支配以改善患者的射血分数的领域。
背景技术
射血分数是指每次心跳从充盈的心室中泵出的血液的百分比。左心室射血分数是对泵入体循环的效率的度量，而右心室射血分数是对泵入肺循环的效率的度量。左心室是心脏的主要泵送腔，其将富含氧的血液通过升主动脉(向上)泵送到身体的其余部分，因此通常在左心室(LV)中测量射血分数。其通过将每搏输出量除以舒张末期容量来计算，并且是心脏泵送效率的固有度量。忙碌跳动但不能成功排出许多血液的心脏被认为处于心力衰竭。
射血分数降低可能有多种原因，包括心肌病、心脏病发作所致的心脏损害、心瓣膜功能失常、长期的不受控制的高血压、高肺心室阻力、动脉的低扩张性等等。
射血分数通常通过超声心动图测量，并用作人心脏功能的一般量度。其它较不常见的方法包括心脏导管插入术、MRI、CT和核方法，例如PET、SPECT和MUGA，其中将微量的放射性物质(例如铊)注入血流中，并且当其流过心脏和肺部时用专用摄像头检测血液中的放射性物质。
表现出良好的心室收缩性的正常射血分数为50％至75％。射血分数降低(小于50％)表示降低的心脏泵送效率，在这种情况下，心脏无法将足够的血液泵送到身体的其它余部位，因而无法满足身体的需求。射血分数降低的患者通常患有呼吸急促、无法运动、下肢肿胀、疲劳和虚弱、精神错乱和心律不齐。35％或更低的射血分数表明心力衰竭、肺充血、心脏肥大或心脏肿大以及肝或肾功能不全的风险增加。
发明内容
在本公开内容的一些实施例中，本公开内容的方面涉及用于改善有此需要的患者的射血分数的方法。
可以通过所谓的生活方式改变(包括低盐饮食、流体管理和运动)来改善适度降低的射血分数。但是，这样的生活方式改变往往是不够的。某些药物可以帮助减轻心脏的负担，增加血液流量，扩大血管或消除体内多余的水分，所有这些都可有助于治疗低射血分数。常用的处方药包括：正性肌力药物(Inotrope)(例如地高辛)、血管紧张素II受体阻滞剂和β阻滞剂。但是，一些患者对这些药物没有响应，而将心脏除颤器植入作为替代方案。因此，仍然需要用于改善患者的射血分数的微创方法。
有利地，本文所述的方法通过使肺脉管系统去神经支配并调节或降低交感神经张力，能够改善患者的射血分数。在其方面，所述方法涉及将动脉操纵装置定位在例如射血分数降低的患者的肺脉管系统内的目标血管内或附近，和使用动脉操纵装置削弱至少一个交感神经、神经纤维或神经元的活动。神经、神经纤维或神经元的削弱导致目标血管的去神经支配，并因此导致射血分数的改善。
许多患有射血分数降低的患者对大多数常规治疗有抗性。本文公开的方法有利地为通常没有实际的治疗选择可用的患有射血分数降低的患者提供治疗。因此，该方法为当前没有有效治疗可用的患者提供了有效的治疗解决方案。
根据一些实施例，提供了一种用于改善有此需要的患者的射血分数的方法，所述方法包括：将肺动脉操纵装置定位在患者的肺脉管系统内的目标血管中；和使用肺动脉操纵装置削弱至少一个交感神经、神经纤维或神经元的活动以将目标血管去神经支配，从而改善患者的射血分数。
根据一些实施例，射血分数是左心室射血分数。
根据一些实施例，射血分数是右心室射血分数。
根据一些实施例，治疗装置包括能量传输装置，所述能量传输装置发射选自由以下组成的组的能量：单极射频、双极射频、超声、微波、光、热、冷辐射、光疗、磁、电、电磁、冷疗、等离子体、机械、化学、动力学、势、核、弹性和流体动力能量，并且其中使用所述治疗装置包括从导管中发射能量。
根据一些实施例，治疗装置包括超声传输装置。根据一些实施例，以1-20MHz的频率发射超声束。根据一些实施例，以8-12MHz的频率发射超声束。
根据一些实施例，改善患者的射血分数包括降低肺血管阻力(PVR)。根据一些实施例，患者具有至少3个伍德单位的肺血管阻力(PVR)。
根据一些实施例，当降低患者的肺毛细血管楔压(pulmonary capillary wedgepressure，PCWP)时，PVR保持基本不变。
根据一些实施例，当用利尿剂、血管扩张剂、抗高血压药物、氧气或其任意组合治疗患者时，PVR保持基本不变。
根据一些实施例，使目标血管去神经支配包括降低目标血管壁内的平滑肌的张力。
根据一些实施例，削弱至少一个交感神经、神经纤维或神经元的活动包括从肺动脉操纵装置发射超声束。根据一些实施例，超声束是未聚焦的超声束。
根据一些实施例，改善患者的射血分数包括提高患者的肺血管扩张性。
根据一些实施例，改善患者的射血分数包括提高患者的肺血管顺应性。
根据一些实施例，改善患者的射血分数包括降低患者的肺血管刚度。
根据一些实施例，改善患者的射血分数包括降低患者的肺血管收缩压。
根据一些实施例，改善患者的射血分数包括降低患者的右心房压力。根据一些实施例，改善患者的射血分数包括增加患者的心输出量。
根据一些实施例，改善患者的射血分数包括增加患者的心脏指数(cardiacindex)。根据一些实施例，改善患者的射血分数包括增加患者的右心房压力。根据一些实施例，改善患者的射血分数导致生活质量(quality of life，QoL)参数的改善。根据一些实施例，本文公开的去神经支配治疗可以改善近端肺动脉的顺应性，这继而可以减少右心室后负荷。
根据一些实施例，所述方法还包括在方法的说明书上指示一种或多种副作用。
根据一些实施例，一种或多种副作用选自由以下组成的组：心律紊乱、心动过缓；血凝块形成、栓塞、局部缺血、局部缺血事件、心肌梗死、卒中、咯血、血肿、挫伤、出血、血管并发症、动脉痉挛、动脉狭窄、动脉剥离、穿孔、肺穿孔、假性动脉瘤、AV瘘；过敏反应、肾功能下降、疼痛、感染、恶心、呕吐、发热、死亡、心肺骤停，抗焦虑药、止痛药成瘾，与手术过程中使用的止痛药相关的副作用、手术过程中使用的抗血管痉挛药相关的副作用、与感染、毒性、不利血液学、出血、咯血、热原性、血管壁或其它身体结构的损伤、肺动脉狭窄、神经损伤、痉挛、动脉瘤形成、动脉瘤破裂、局部解剖结构损伤、心脏神经丛损伤、食道损伤、气管损伤、肺损伤、迷走神经损伤、心动过缓、心动过速、部分声带麻痹、咳血、肺功能下降、高血压、灌注不足或其任意组合相关的副作用。
本公开内容的某些实施例可以包括以上优点中的一些、全部或不包括。根据本文所包括的附图、说明书和权利要求书，一种或多种技术优点对于本领域技术人员而言是明显的。此外，尽管上面已经列举了具体的优点，但是各种实施例可以包括所列举的优点中的全部、一些或不包括。
附图说明
这里参考附图描述了本公开内容的一些实施例。该描述与附图一起使得可以如何实践本公开内容的一些实施例对本领域普通技术人员变得明显。这些图仅用于说明目的。
图1是根据一些实施例的用于改善患者的射血分数的方法的说明性流程图；和
图2是本文实例1中描述的TROPHY 1研究的说明性流程图；
图3A显示了去神经支配手术后4个月的平均肺动脉压(mPAP)的平均变化(平均值/标准误差；Wilcoxon检验4M vs基线；n＝11(不包括患者001-004))；
图3B显示了去神经支配手术后4个月的心脏指数的平均变化(平均值/标准误差；Wilcoxon检验4M vs基线；n＝11(不包括患者001-004))；
图3C显示了去神经支配手术后4个月的肺血管阻力(PVR)的平均变化(平均值/标准误差；Wilcoxon检验4M vs基线；n＝11(不包括患者001-004))；
图3D显示了去神经支配手术后4个月的右动脉压(RAP)的平均变化(平均值/标准误差；Wilcoxon检验4M vs基线；n＝11(不包括患者001-004))；
图4A显示了去神经支配手术后4个月的生活质量(QoL)评分的平均变化(平均值/标准误差；Wilcoxon检验4M vs基线；n＝11(不包括患者001-004))；
图4B显示了去神经支配手术后4个月的6分钟行走距离(6MWD)的平均变化(平均值/标准误差；Wilcoxon检验4M vs基线；n＝11(不包括患者001-004))；和
图4C显示了去神经支配手术后4个月的每日活动(活动度测定(actimetry))的平均变化(平均值/标准误差；Wilcoxon检验4M vs基线；n＝11(不包括患者001-004))。
具体实施方式
在以下描述中，将描述本公开内容的多个方面。为了说明目的，阐述了特定的配置和细节，以便提供对本公开内容的不同方面的透彻理解。然而，对于本领域的技术人员来说明显的是，可以在没有本文给出的具体细节情况下实践本公开内容。此外，可以省略或简化公知的特征，以免使本公开内容变得模糊。
本公开内容总体上涉及肺动脉去神经支配以用于改善有此需要的患者的射血分数，特别是左心室射血分数的领域。
根据一些实施例，所述方法涉及将动脉操纵装置定位在例如射血分数降低的患者的肺脉管系统内的目标血管内或附近，和使用动脉操纵装置削弱至少一个交感神经、神经纤维或神经元的活动。神经、神经纤维或神经元的削弱导致目标血管的去神经支配，并因此导致射血分数的改善。
根据一些实施例，可以处理交感神经和副交感神经，在另一些替代实施例中，可以仅处理副交感神经。根据一些实施例，可以在神经元-神经元水平上处理神经。根据一些实施例，可以处理整个神经。为了本公开内容的目的，短语“神经或神经元”可以用于处理一个或多个完整的神经、一个或多个神经纤维和/或一个或多个神经元。
根据一些实施例，神经元或神经将被简单地下调。或者，在另一些实施例中，通过神经支配肺脉管系统来降低交感神经张力可涉及部分或完全破坏一个或多个交感神经。这种部分或完全神经破坏的过程在本文中可以被称为“去神经支配”或“使结构去神经支配”。例如，在一些实施例中，治疗可以涉及使供应肺的一个或多个动脉(例如但不限于肺动脉干、左肺动脉和/或右肺动脉)去神经支配。根据一些实施例，可以将使血液从肺返回心脏的一个或多个静脉去神经支配。这种通过使肺脉管系统去神经支配来调节或降低胸交感神经张力的方法是一种治疗射血分数受损的独特方法。
如本文所用，术语“动脉操纵装置”可以指被配置为改善患者的射血分数的任何装置。根据一些实施例，动脉操纵装置可以包括或可以是血管内治疗装置。根据一些实施例，操纵装置可以包括被配置为引起肺动脉去神经支配的装置。
根据一些实施例，操纵装置可以包括射频发射器。根据一些实施例，肺动脉操纵装置可包括改良的射频发射器。根据一些实施例，肺动脉操纵装置可包括激光器。
根据一些实施例，操纵装置可以包括导管和安装在导管上的超声发射器。根据一些实施例，超声束可以是未聚焦的超声束。根据一些实施例，超声束可以是高强度聚焦超声束。根据一些实施例，超声束可以是低频超声束。根据一些实施例，可以以1-50Mhz、5-15Mhz、8-12Mhz或任何其它合适的频率发射超声束。每种可能性都是单独的实施例。
根据一些实施例，导管的长度可以为100-150cm，例如但不限于约120cm。
在一些实施例中，在每个部位的治疗持续时间在例如10-80秒的范围内，例如20秒、40秒、70秒或中间的、较短或较长的时间段。
在一些实施例中，所施加的超声强度在例如30-70W/cm^2的范围内，例如40W/cm^2、50W/cm^2、60W/cm^2或中间的、较高或较低的强度。
根据一些实施例，所述方法包括将肺动脉操纵装置定位在目标血管内或附近。
如本文所使用的，术语“附近”可以指的是操纵装置接触目标血管或与目标血管的壁相距1mm、2mm、5mm、1cm或更多。每种可能性都是单独的实施例。
根据一些实施例，将治疗装置定位在目标血管内或附近可以削弱至少一个交感神经、神经纤维或神经元的活动。根据一些实施例，削弱至少一个交感神经、神经纤维或神经元的活动可以使目标血管去神经支配，从而改善患者的射血分数。
在一些实施例中，在治疗之前、之后和/或期间采取以下一种或多种安全措施：在一些实施例中，导管仅用于治疗单个患者；在一些实施例中，避免导管的再次消毒和/或重复使用；在一些实施例中，导管仅与其兼容控制台(console)一起使用；在一些实施例中，在避免在制备过程中将直接压力施加到间隔装置(distancing device)和/或装置的超声换能器上的同时执行该方法；在一些实施例中，在治疗期间，如果间隔装置打开，则避免导管的操纵和/或缩回；在一些实施例中，在能量输送过程中，不移动导管；在一些实施例中，例如在手术期间除了导管之外还使用其它电气装置的情况下，通过拔下电源电缆和/或撤回导管来断开系统；在一些实施例中，在间隔装置发生故障的情况下，间隔装置可以与导管和/或与引导护套一起缩回；在进行X线透视检查的某些情况下，应注意避免使患者过度暴露于造影剂；在一些实施例中，在治疗之前，为患者提供全身性抗凝剂。任选地，在治疗过程中监测激活凝血时间(activated clotting time，ACT)。在某些情况下，应保持至少250秒的ACT。在一些实施例中，仅允许训练有素的合格医疗人员(例如，右心导管插入术专家)使用导管和/或控制台；在一些实施例中，在手术期间，应可用超声心动图以及用于心包填塞(pericardial tamponade)的诊断和即时治疗措施的装置；在一些实施例中，应注意避免在闭路式环境中在不受控制的易燃洗涤剂、麻醉剂、一氧化二氮(N2O)或氧气的存在下使用电子医疗能源；在一些实施例中，仅在培训完成之后才允许使用系统；在发生肺动脉组织切开或穿孔的某些情况下，插入导管时应格外小心；在一些实施例中，导管和/或其它附件(例如，间隔装置)将根据已建立的生物危害性废物处置的医院规程进行处置；在一些实施例中，仅处理预定的预期目标区域；在一些实施例中，可以在手术之前和/或过程中使用电动和/或自动造影剂注射装置；任选地，考虑用于流动注射和/或造影剂递送的指定设置；在一些实施例中，应避免水进入控制台；在某些情况下，如果患者在治疗期间遭受过度疼痛，则应考虑镇痛和/或镇静；在某些情况下，如果使用射线照相，则应处理辐射危害。
根据一些实施例，该方法还包括在使用说明书上指示一种或多种副作用。根据一些实施例，副作用可以选自由以下组成的组：心律失常，包括心动过缓；血凝块形成和/或栓塞，可能导致局部缺血事件，例如心肌梗塞、卒中、咯血(hemoptysis)；血肿、挫伤、出血；血管并发症，包括动脉痉挛、动脉狭窄、动脉剥离(arterial dissection)、穿孔、肺穿孔、假性动脉瘤、AV瘘；与手术过程中使用的造影剂相关的并发症，例如严重的过敏反应或肾功能下降；疼痛；感染；恶心或呕吐；发热；死亡；心肺骤停；与手术过程中使用的造影剂、麻醉药、抗焦虑药、其它止痛药和抗血管痉挛药相关的风险；生物危害：感染、毒性、不利血液学、过敏、出血、咯血、疼痛和热原性的风险；能量传输对血管壁或其它身体结构的损害，例如肺动脉狭窄、神经损伤、痉挛、动脉瘤形成或破裂；对局部解剖结构例如心脏神经丛、食道、气管、肺或迷走神经的意外/未预料的损伤，导致心动过缓、心动过速、部分声带麻痹或咳血(Haemoptysis)；肺功能下降；高血压；灌注不足，或其任意组合。每种可能性都是单独的实施例。
如本文所指，术语“患者”和“受试者”可以互换使用，并且可以涉及射血分数降低的受试者。
如本文所用，术语“射血分数”是指随着每次心跳从充盈的心室中泵出的血液的百分比。根据一些实施例，射血分数可以是左心室射血分数。根据一些实施例，射血分数可以是右心室射血分数。
根据一些实施例，射血分数降低可以被定义为低于55％、低于50％或低于35％的射血分数。每种可能性都是单独的实施例。
根据一些实施例，射血分数降低的患者可以包括跨肺梯度(trans-pulmonarygradient，TPG)增加和/或肺血管阻力(pulmonary vascular resistance，PVR)升高的患者。如本文所用，术语“跨肺梯度”可以指平均肺动脉压(mPAP)与左心房压(PLA；通常通过肺毛细血管楔压PCWP估计)之间的差。根据一些实施例，TPG增加可以指mPAP-PCWP超过12至15mmHg。根据一些实施例，PVR升高可以指高于2伍德单位(Wood unit)、高于2.5伍德单位、高于3伍德单位或高于3.5伍德单位的PVR。
根据一些实施例，改善射血分数可以包括使射血分数增加百分之五或百分之十。
根据一些实施例，改善射血分数可包括降低肺脉管系统的至少一条动脉中的肺血管阻力(PVR)。
根据一些实施例，患者的PVR为至少2.5伍德单位。根据一些实施例，当降低患者的肺毛细血管楔压(PCWP)时，患者的PVR保持基本变。根据一些实施例，当用利尿剂和/或血管扩张药治疗患者时，患者的PVR保持基本不变。
根据一些实施例，削弱至少一个神经、神经纤维或神经元的活动可以包括提供单极射频、双极射频、超声、光、热、冷辐射、微波辐射、光疗、磁疗、电磁辐射、电疗、冷疗、等离子体疗法、机械操纵、动力学疗法、核疗法、弹性和流体动力能量。
根据一些实施例，削弱至少一个神经、神经纤维或神经元的活动可以包括从肺动脉操纵装置发射超声束。
根据一些实施例，改善患者的射血分数包括增加患者的心脏指数。如本文所用，术语“心脏指数(cardiac index)”和“CI”是可互换的，并且是指将在一分钟内来自左心室的心输出量(cardiac output，CO)与体表面积(body surface area，BSA)相关联的血液动力学参数，从而使心脏功能与个体的尺寸相关联。测量单位是升每分钟每平方米(L/min/m2)。休息(rest)时心脏指数的正常范围是2.6-4.2L/min/m2。
根据一些实施例，改善患者的射血分数包括增加患者的右心房压力。如本文所用，术语“右心房压力”、“RA压力”和“RAP”可互换地是指心脏右心房中的血压。RAP反映了返回心脏的血液量和心脏将血液泵入动脉系统的能力。RAP的正常范围是2-6mmHg或低于8mmHg。
根据一些实施例，改善患者的射血分数导致生活质量(quality of life，QoL)参数的改善。合适的QoL参数的非限制性实例包括：生活质量(QoL)评分(患者对其生活质量的主观评估)；6分钟行走距离(6MWD)，活动度测定(actimetry)(每日活动)。
根据一些实施例，本文公开的去神经支配治疗可以改善近端肺动脉的顺应性，这继而可以减少右心室后负荷。
现在参考图1，其是根据一些实施例的用于改善患者的射血分数的方法100的说明性流程图。在步骤110中，将肺动脉操纵装置定位在射血分数降低的患者的肺脉管系统内的目标血管中。根据一些实施例，肺动脉操纵装置可以是超声传输装置，如本文基本上描述的。在步骤120中，削弱至少一个交感神经的活动，以使目标血管去神经支配，从而改善患者的射血分数。
实例
实例1-在人类研究(TROPHY 1)中，肺动脉去神经支配改善射血分数
TROPHY 1研究是用于在射血分数降低的患者中进行肺动脉去神经支配的治疗性血管内超声(TIVUSTM)系统的临床评估。研究的概要在图2的流程图中示出。15名患者登记在研究中，并且从三名患者获得了初步结果。该研究旨在直接和通过评估心功能、运动耐力(6分钟行走距离)和生活质量问卷评估肺去神经支配对射血分数的安全性、性能和初始有效性。根据制造商的说明，在右、左和主肺动脉进行(在符合研究标准的患者中)肺去神经支配。去神经支配手术的平均时间为20-30分钟，并且操作员的可用性反馈优异。根据特定患者的解剖结构，每个患者的去神经支配部位的数量在6到16之间变化。手术后，根据研究方案在手术后1、4、8和12个月对患者进行评估。术前以及术后1和12个月使用MRI测量患者的射血分数。来自1个月随访的最初的结果(n＝3)表明在肺去神经支配后左、右心室的射血分数平均增加28％，如下表1所示。
表1-肺去神经支配之前的和之后一个月的基于MRI的射血分数
在4个月的随访中，所有主观和客观的可测量参数均得到改善。图3A至图3D显示了去神经支配手术后4个月的血液动力学参数的平均变化(平均值/标准误差；Wilcoxon检验4M vs基线；n＝11(不包括患者001-004))。
有利地，平均肺动脉压(mPAP)降低了13.5％(平均值±sd＝-7.2±6.6,p＝0.010)，如图3A所示；心脏指数增加了2％(平均值±sd＝0.15±0.52,p＝0.695)，如图3B所示；肺血管阻力(PVR)降低了15.0％(平均值±sd＝-1.32±0.98,p＝0.003)，如图3C所示；并且右动脉压降低了20.5％(平均值±sd＝-2.45±3.5,p＝0.053)，如图3D所示。这些结果表明，治疗性血管内超声治疗可改善近端肺动脉顺应性，从而减少右心室后负荷。
图4A至图4C显示了去神经支配手术后4个月的生活质量(QoL)参数的平均变化(平均值/标准误差；Wilcoxon检验4M vs基线；n＝11(不包括患者001-004))。
有利地，观察到由EmpHasis-10降低21％指示的生活质量评分(QoL)的正变化(平均值±sd＝-6.9±14,p＝0.275)，如图4A所示。而且，同样观察到6分钟行走距离(6MWD)提高了40米(21％)(平均值±sd＝45.5±64.6,p＝0.065)，如图4B所示，以及每日活动量(活动度测定)提高了12％(平均值±sd＝584±883,p＝0.141)，如图4C所示。
上述实例是非限制性实例，而并非旨在限制本公开内容的范围。所描述的实例可以包括不同的特征，并非所有特征在本公开内容的所有实施例中都是必需的。
本文所使用的术语仅出于描述特定实施例的目的，而并非旨在进行限制。如本文所用，未用数量词限定的名词也意图包括复数形式，除非上下文另外明确指出。将进一步理解的是，当在本说明书中使用术语“包括”或“包含”时，其指定存在指出的特征、整数、步骤、操作、元件或组件，但是不阻止或排除一个或多个其它特征、整数、步骤、操作、元件、组件或其组的存在或添加。
在本申请的说明书和权利要求书中，词语“包括”、“包含”和“具有”中的每一个及其形式不必限于列表中与该词语可能关联的成员。
尽管上面已经讨论了许多示例性方面和实施例，但是本领域技术人员将认识到其某些修改、置换、添加和子组合。因此，旨在将后附权利要求书和此后引入的权利要求书解释为包括在其真实精神和范围内的所有这样的修改、置换、添加和子组合。

Claims (16)

1.一种用于改善有此需要的患者的射血分数的方法，所述方法包括：
将肺动脉操纵装置定位在所述患者的肺脉管系统内的目标血管中；和
使用所述肺动脉操纵装置削弱至少一个交感神经、神经纤维或神经元的活动以将所述目标血管去神经支配，从而改善所述患者的所述射血分数。
2.根据权利要求1所述的方法，其中所述射血分数是左心室射血分数。
3.根据权利要求1所述的方法，其中所述射血分数是右心室射血分数。
4.根据权利要求1至3中任一项所述的方法，其中该治疗装置包括能量传输装置，所述能量传输装置发射选自由以下组成的组的能量：单极射频、双极射频、超声、微波、光、热、冷辐射、光疗、磁、电、电磁、冷疗、等离子体、机械、化学、动力学、势、核、弹性和流体动力能量，并且其中使用所述治疗装置包括从导管中发射能量。
5.根据权利要求1至4中任一项所述的方法，其中所述治疗装置包括超声传输装置。
6.根据权利要求5所述的方法，其中以1-20MHz的频率发射超声束。
7.根据权利要求6所述的方法，其中以8-12MHz的频率发射超声束。
8.根据权利要求1至7中任一项所述的方法，其中改善所述患者的射血分数包括降低所述肺脉管系统的至少一条动脉中的肺血管阻力(PVR)。
9.根据权利要求1至8中任一项所述的方法，其中所述患者具有至少3个伍德单位的肺血管阻力(PVR)。
10.根据权利要求9所述的方法，其中当降低所述患者的肺毛细血管楔压(PCWP)时，所述PVR保持基本不变。
11.根据权利要求1至10中任一项所述的方法，其中当用利尿剂、血管扩张剂、抗高血压药物、氧气或其任意组合治疗所述患者时，所述PVR保持基本不变。
12.根据权利要求1至11中任一项所述的方法，其中使所述目标血管去神经支配包括降低所述目标血管的壁内的平滑肌的张力。
13.根据权利要求1至12中任一项所述的方法，其中削弱至少一个交感神经、神经纤维或神经元的活动包括从所述肺动脉操纵装置发射超声束。
14.根据权利要求13所述的方法，其中所述超声束是未聚焦的超声束。
15.根据权利要求1所述的方法，还包括在所述方法的说明书上指示一种或多种副作用。
16.根据权利要求15所述的方法，其中所述一种或多种副作用选自由以下组成的组：心律紊乱、心动过缓；血凝块形成、栓塞、局部缺血、局部缺血事件、心肌梗死、卒中、咯血、血肿、挫伤、出血、血管并发症、动脉痉挛、动脉狭窄、动脉剥离、穿孔、肺穿孔、假性动脉瘤、AV瘘；过敏反应、肾功能下降、疼痛、感染、恶心、呕吐、发热、死亡、心肺骤停，抗焦虑药、止痛药成瘾，与手术过程中使用的止痛药相关的副作用、与手术过程中使用的抗血管痉挛药相关的副作用、与感染、毒性、不利血液学、出血、咯血、热原性、血管壁或其它身体结构的损伤、肺动脉狭窄、神经损伤、痉挛、动脉瘤形成、动脉瘤破裂、局部解剖结构损伤、心脏神经丛损伤、食道损伤、气管损伤、肺损伤、迷走神经损伤、心动过缓、心动过速、部分声带麻痹、咳血、肺功能下降、高血压、灌注不足或其任意组合相关的副作用。
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