CN101400403A - 利用电调制来治疗过敏反应的方法和装置 - Google Patents
利用电调制来治疗过敏反应的方法和装置 Download PDFInfo
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- A61N1/36—Applying electric currents by contact electrodes alternating or intermittent currents for stimulation
- A61N1/3605—Implantable neurostimulators for stimulating central or peripheral nerve system
- A61N1/36128—Control systems
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Abstract
用于治疗过敏反应、过敏性休克、支气管收缩和/或哮喘的方法和装置,包括向经受过敏反应的病人的迷走神经的选择区域提供电脉冲,以阻断和/或调节神经信号,所述神经信号是调节,例如心肌组织、血管扩张/收缩和/或肺组织的功能。
Description
发明领域
本发明涉及用于治疗目地的向身体组织输出电脉冲的领域,和更特别涉及通过阻断和/或调节迷走神经中的信号来治疗与休克,例如过敏反应相关的身体状况的装置和方法。
背景技术
对于各种疾病的治疗,有许多需要破坏其他健康组织以便产生有益效果。机能紊乱组织被识别,然后被损坏或用别的方式危害,以便产生有益的结果,而不是企图修复这些组织到它们正常的功能。虽然有各种不同的设计成直接集中破坏靶神经组织的技术和机制,但附带损害是不可避免的。
其他对于机能紊乱组织的治疗可以是自然医学,在多数情况下是使病人变得依赖人工合成的化学药品。其实例有抗哮喘药例如沙丁胺醇,质子泵抑制剂例如奥美拉唑(Prilosec),膀胱痉挛缓解剂例如奥昔布宁和降低胆固醇药如立普妥和辛戈他丁。在多数情况下,这些医疗途径具有或未知或相当显著的副作用,例如,至少20世纪90年代晚期的一种常用的减肥丸被后来发现导致心脏病发作和中风。
因此,不幸地是,外科和医学的有益结果经常是以其他组织的功能损坏或副作用的风险为代价来实现的。
近2000年来,电刺激用于医学健康状况治疗的用途已经被本领域所熟知。已经认识到对脑和/或周围神经系统和/或直接刺激故障组织的电刺激对于许多疾病的治疗具有显著的作用,所述刺激通常是一种整体可逆的和无损的治疗。
用埋藏电极对脑的电刺激已经被批准用于各种健康状况的治疗,包括疼痛和运动障碍,所述运动障碍包括原发性震颤和帕金森氏病。在这些途径背后的原理包括瓦解和调节在脑中特定位置的活动亢进的神经元的回路传递。与非常危险的物理清除显示病态的脑部分的破坏步骤相比,电刺激通过在这些位点植入电极达到首先感知异常电信号,然后输送电脉冲以局部瓦解病态神经元传递,驱使其恢复正常活性范围。这些电刺激步骤虽然有侵入,但通常是在患者有意识和外科参与下进行的。
脑刺激,和特别是深部脑刺激,并非没有一些缺点。步骤需要穿透颅骨、和利用导管形的导线将电极插入到脑物质中等等。当监视病人的健康状况(例如震颤活动等等)时,电极的位置被调节到能获得显著的治疗电位。下一步,再对电刺激信号作出调整,例如频率、周期、电压、电流等等,以实现治疗结果。随后,电极被永久的植入,和导线被从电极引到外科埋入起搏器的位置。所述起搏器向电极提供电刺激信号以维持治疗作用。实现深部脑刺激的治疗结果的同时,存在有由植入步骤引起的显著的并发症,包括由对周围组织和神经血管系统损害所诱导的中风。
肌肉和神经之间关系的这种基本理解的一个最成功的现代应用是心脏起搏器。虽然其起源延伸至19世纪,但直到1950年其才第一次实施,而且开发的是体外的笨重的起搏器。Dr.Rune Elqvist在1957年开发了第一个真正起作用的,可佩戴的起搏器。之后不久,在1960年,开发了第一个完全植入式的起搏器。
在这个时间附近,还发现可以通过静脉将电导线连接到心脏,其取消了打开胸腔和连接导线到心壁的需要。在1975年锂碘电池的引入将起搏器的电池寿命从几个月延长到了超过10年。现代起搏器可以治疗心肌中各种不同信号的病变,和也可以作为心脏除颤器(见授权给Deno等的美国专利6,738,667,其公开在此引入作为参考)。
过敏反应是一种严重的变态反应,当躯体暴露于一种先前被致敏的物质时发生。这种反应导致来自躯体组织内细胞的化学物质,包括组胺的急剧释放。这些化学物质扩张血管、降低血压,并导致血管漏液。这些化学物质还作用于肺,导致导气管收缩,所述收缩使呼吸非常困难。
有时候,过敏反应是温和的,仅导致荨麻疹和痒;然而,过敏反应也可以是致命的。在过敏性休克中,其为最严重类型的过敏反应,血压严重的下降和支气管组织剧烈地肿胀。这导致人窒息和虚脱。如不及时治疗,过敏性休克是致命的,并仅在美国每年就导致超过八千例死亡。对于这种致命反应的触发物覆盖到了暴露于坚果、昆虫刺螫、药物等等的范围。然而,这些触发物是由一系列超敏反应介导的,所述超敏反应导致无法控制的血压下降和由平滑肌收缩驱动的导气管闭塞。
给予哮喘和过敏性支气管收缩两者的通用介质,不令人惊讶的是,哮喘患者具有过敏反应的特定风险。而且,估计对这种反应敏感的人数仅在美国就超过4000万。悲剧性地,这些病人中的许多完全了解他们健康状况的严重性,并在控制疾病发作的徒劳努力中死亡。这些事件中的许多都发生在医院或在救护车中,当着高度训练的医务人员的面,这些医护人员无力中止影响他们患者的血压过低和支气管收缩循环。典型的,过敏反应的严重性和发病快不允许疾病接受缓慢的治疗,而是需要更快速的进行治疗。最常规的用于治疗过敏反应的药物疗法是肾上腺素,通常市售名称为“Epi-pen”的制剂和给药装置,潜在的患者一直携带它。除了作为极度的支气管扩张药之外,肾上腺素还剧烈的升高患者的心率,和可能导致心动过速和心脏病发作。
衬于支气管通道的平滑肌受迷走和交感神经纤维丛的混合控制。在哮喘发作和过敏性休克期间的支气管痉挛通常能直接联系到这些丛内的病态信号。过敏性休克和哮喘是主要的健康问题。
哮喘,及炎症反应产生的其他导气管闭合紊乱和炎症介导的支气管收缩,在美国影响估计八百万至一千三百万成人和儿童。哮喘的重要子类是患有严重哮喘病。在美国每年有估计5000人死于哮喘发作。某些国家高达百分之二十的人口受哮喘的影响,全世界估计有超过一亿人。尽管抗哮喘药的使用在增加,但在大多数国家中哮喘相关疾病和死亡率仍在上升。
哮喘的特征为导气管的慢性炎症状况。典型的症状是咳嗽、哮鸣、胸部紧缩感和气促。哮喘是对体外物质,例如花粉、尘螨和香烟烟雾的敏感性增加的结果。躯体对导气管中这些体外物质的存在事实上作出了过度的反应。作为哮喘反应的一部分,粘液产生的增加经常被触发,加剧了导气管的阻塞。围绕导气管的平滑肌开始痉挛、导致导气管收缩。导气管也发生炎症随着时间的过去,这种炎症可以产生导气管的瘢痕,并进一步减少气流。这种炎症导致导气管更易被激惹,其可以导致咳嗽的增加和哮喘急性发作敏感性的增加。
存在两种医学策略用来治疗哮喘患者的这个问题。通过在症状发作后使用吸入药物,或通过长期使用注射和/或口服治疗来典型的控制状况。药物被典型的分成两类;治疗炎症的,和治疗平滑肌收缩的。首先是给予抗炎药物,象类固醇,以治疗导气管组织,减少其向外过度释放调节炎性过程的分子的倾向。第二策略是给予平滑肌弛缓药(抗胆碱能的和/或抗肾上腺素的药物)以降低平滑肌收缩的能力。
非常优选,患者依赖于避免触发和抗炎药物,而不是用支气管扩张药作为他们的一线治疗。然而,对于某些患者,这些药物,甚至支气管扩张药也不能胜任阻止他们支气管通道的收缩,并且每年超过五千人由于哮喘发作而窒息和死亡。
心肌的机能障碍包括整体心肌性能的下降。心肌性能的决定因素是心率、前负荷、后负荷和收缩性。心率是一种用来描述心动周期频率的术语,通常是每分钟心脏收缩(心搏)的次数。心脏包含两个天然的心脏起搏器,所述心脏起搏器自发地引起心脏搏动。这可以受植物神经系统和循环中的肾上腺素控制。
身体可以增加心率以响应多种需要增加心输出量(单位时间心脏射出的血液量)的状况。锻炼、环境应激和心理应力可能导致心率在静息心率的基础上增加。脉搏是最简单的测量心率的方法,但当某些搏动没有产生大的心输出量时,其可能是靠不住的。在这些情况下(如同在某些心律不齐中发生的),心率可能是显著的高于脉搏。
前负荷在理论上最精确的描述了在收缩之前心肌细胞的初始伸张。前负荷是在被动充盈和心房收缩之后存在于心室中的血液量。前负荷受静脉血压和静脉血回流率的影响。而这些受静脉紧张性和循环血液量的影响。
后负荷是心室为了收缩产生的心室张力。后负荷还可以被描述为,心室为了从室内射出血液所不得不产生的压力。就左心室来说,后负荷是血压的结果,因为为了打开主动脉瓣心室中的压力必须要大于血压。例如,高血压(增加的血压)增加了左心室的后负荷,因为左心室不得不更强烈的工作以将血液射入主动脉中。这是因为直到左心室内产生的压力高于被升高的血压时主动脉瓣才会打开。
收缩性是心肌纤维的固有能力,可在任意给定的纤维长度收缩。如果当前负荷、后负荷和心率全部不变时心肌性能改变,那么性能的改变必然是由于收缩性的改变。影响收缩性的化学物质被称为影响肌收缩力的药剂。例如增加收缩性的药物例如儿茶酚胺类(去甲肾上腺素和肾上腺素),被认为具有正的影响肌收缩力作用。所有引起收缩性增加的因素都是通过引起收缩期内细胞内钙浓度[Ca++]的增加来工作的。
收缩性的概念对解释为什么即使前负荷、后负荷和心率全部保持不变,某些介入(例如肾上腺素输注)还是可以引起心肌性能的增加(如在实验室中显示的)是非常必要的,如试验中所示的。控制其他因素的实验工作是必须的,因为收缩性的改变通常不是一种孤立的作用。例如,交感神经对心脏刺激的增加升高了收缩性和心率。收缩性的升高趋于增加每搏出量,和因此前负荷继发性的降低。
血压是血液施加到血管壁上的压力。除非另外指示,血压是指全身性动脉血压,即,向除肺之外的身体部位输送血液的大动脉中的血压,例如肱动脉(在手臂内)。在其他血管中的血液压力均低于动脉压。血压值通常用毫米汞柱(mmHg)表述,和总是以与大气压力相关给出。例如,动脉中血液的绝对压力用平均动脉压表述为100mmHg,在一个有760mmHg大气压力的日子,血压值是860mmHg。
收缩压被定义为心动周期中动脉内的峰值压力;舒张压是最低压力(在心动周期的静息期)。平均动脉压和脉压是另外的重要参数。对于静息的、健康成年人的典型数值是收缩压约120mmHg和舒张压约80mmHg(写为120/80mmHg),但有很大的个体差异。这些血压的测量值不是静态的,而是从一个心跳到另一个心跳或者整天(昼夜节律)内都经历有正常的变化;它们还可以响应刺激、营养要素、药物或疾病来改变。
迷走神经与血压调节之间关系的实例可以发现于授权给Terry等的、名称为“Treating refractory hypertension by nervestimulation”的美国专利5,707,400("′400")中,其在此全部引入作为参考。高血压(高于正常血压)和它的反面,低血压(低于正常血压),主要地代表了涉及血压的问题的正反两个方面。涉及低血压的主题、其原因和作用,也在Daum等的名称为“Systems and methodsfor hypotension”的美国专利申请20050283197A1中进行了讨论,其在此以全部引入作为参考。
超过正常值的血压被称为高动脉压。其本身很少是急性问题,仅有很少地例外的高血压危象,例如有器官系统(尤其是中枢神经系统、心血管系统和/或肾系统)急性损伤和不可逆器官损害可能性的严重高血压。然而,由于其长期的间接效应(以及作为其他问题的指示),诊断医师对其有严重的担忧。持续的高血压对中风、心脏病发作、心力衰竭、动脉的动脉瘤来说是一个危险因素,和是糖尿病之后慢性肾衰竭的次主要原因。
所有水平的血压都在动脉壁上给予机械应力。更高的血压增加心脏的工作负荷和增加在动脉壁内产生的非健康组织生长(动脉粥样化)的进展。压力越大,存在的应激越大和更趋于产生动脉粥样化,和心肌更趋于变厚、变大和随着时间的过去变得更虚弱。
血压过低被称为低血压。低血压是严重疾病的信号,和需要更紧急的医学保养。当血压和血流非常低时,脑灌流被严重减少(即,血液供给不充分),导致头昏眼花、眩晕、虚弱和晕厥。
当病人从坐位站立起来时,有时血压显著的下降。这被称为体位性低血压;重力减少了从低于心脏的身体静脉流回心脏的血液的比率,从而降低了每搏量和心输出量。当人们健康时,他们很快收缩低于心脏的静脉和增加他们的心率,以最小化和补偿重力影响。这是通过植物神经系统在潜意识水平进行的。这个系统通常需要几秒钟以完全调节好,和如果补偿太缓慢或不充分,个体将经受流向大脑的血量降低、眩晕和潜在的一时性黑蒙。重力载荷的增加,例如超音速喷气机飞行员"pulling Gs"通常的感受到的,大大的加强了这种作用。与重力垂直的躯体复位极大的消除了这个问题。
低血压经常伴随有许多其他全身性健康问题和使许多其他全身性健康问题变得复杂,例如过敏反应和败血症,导致过敏性休克和脓毒性休克,使处理进展中的健康问题更加困难。例如,Ben Ezra等的名称为"Applications of vagal stimulation"的美国专利申请20050065553,其在此全文引入作为参考,给出了一种通过向迷走神经施用合适的配置电流来治疗病人败血症的方法。然而,当合并有难治的低动脉压时,败血症变成了了脓毒性休克。
脓毒性休克是一种严重的医学状况,导致例如与感染和败血症相关的多器官衰竭和死亡作用。最常见的受害者是孩子和老人,因为他们的免疫系统不能克服感染,以及也是这种状况的发育完全的成年人,以及免疫能力受损伤的个体。脓毒性休克的死亡率约是50%。其他各种休克状况包括:全身性的炎症反应综合症、中毒性休克综合症、肾上腺机能不全和过敏反应。
休克的一个子集,分布性休克是特别指降低的组织灌流导致的末端器官机能障碍。在大规模炎症反应中释放的细胞因子TNFα、IL-1β、IL-6可以引起大量的血管舒张,增加毛管渗透性、减少体循环血管阻力和低血压。低血压减少组织灌流压力,和因此结果产生组织缺氧。最后,为了补偿降低的血压,将产生心室扩张和心肌机能障碍。
因此,在本领域有对治疗过敏反应、过敏性休克、支气管收缩、哮喘等等的紧急症状的新产品和方法的需求。
发明内容
本发明包括利用电信号来治疗过敏反应的产品和方法,所述电信号可以被应用到迷走神经以暂时阻断和/或调整迷走神经的信号。本发明还包含过敏反应、过敏性休克、支气管收缩、哮喘等等的治疗。
在一个或多个具体方案中,本发明聚焦于向迷走神经的至少一个选择区域传递一个或多个电脉冲的方法和装置,以阻断和/或调节信号,所述信号是至心肌纤维促进收缩性的、至围绕心脏组织的纤维促进心脏功能增加的(从而升高血压)、和/或至围绕支气管的肌纤维(促进导气管开放的)。
可以理解,这些脉冲可以由经受过敏反应的病人直接手动来激活。
在本发明的一个或多个具体方案中,脉冲的施用方式为,松驰心肌以降低紧张性收缩的基线水平、影响血管收缩(或扩张)、和某些休克情况下,松弛沿支气管通道排列的平滑肌以减轻痉挛的发生,例如在过敏性休克期间。所述脉冲可以通过固定导线在分别控制心搏动和/或支气管活动的神经上来施用,例如迷走神经的右和/或左支的上和/或下心脏支、和/或前和/或后支气管支,其与来自交感神经链的纤维一起形成前和后冠状动脉和肺丛。导线可以被固定在迷走神经的心和肺支的两个或一个上,以包含对两个器官的阻断和/或调节。还可以理解也可以使用本领域所示的无导线脉冲用于向目标区域施用脉冲。
向迷走神经选定区域施用合适的脉冲的机制可以包括将电导线的末端固定在控制心肌、心脏的血管(例如,去影响血管收缩/扩张)和/或肺肌肉的神经组织附近,其中导线与可植入的或外部的电脉冲发生装置连接在一起。在导线的末端产生的电场创造了透入靶神经纤维的作用场,并引起至目标肌肉的信号的阻断和/或调节。
参考本文的附图和权利要求书,在下面的发明详述部分将更加完整的描述电脉冲的应用,所述电脉冲的应用为向迷走神经或者向到心肌和/或支气管肌肉的迷走神经纤维分支施用电脉冲以调节副交感神经的张力用于松弛身体对过敏的反应。
当联合附图和这里的发明内容时,其他目地、特征、优点等等将对本领域技术人员来说变得显而易见。
附图说明
为了说明本发明的各个方面,用图的形式显示了目前优选的方案,然而可以理解,本发明不被限制到显示的这些精确的数据、方法、布置和工具,而是仅被限制到授权的有效的权利要求。
图1是一个交感和副交感神经系统的示意图;
图2是一个颈、胸和腹部选择部位的截面解剖图。
图3图解了显示于图1和2中的迷走神经的简单视图;
图4根据本发明的一个具体方案,图解了一个典型的用于阻断和/或调节脉冲的电压/电流分布图,所述脉冲被应用到迷走神经的一个或多个部分;和
图5-7图解了根据本发明的多个具体方案获得的典型实验数据。
最佳实施方式
可以理解,此处公开的具体方案代表了本发明优选的方式和因此作为本发明的实施例提供。然而,本发明的范围将不限于这些公开,也不受临时权利要求的限制。
在过敏反应(例如,包括支气管收缩和/或低血压)的准确生理学原因还没有被确定的情况下,本发明假定对平滑肌收缩的直接介导是迷走神经过度活性的结果,其是前炎症介质流与在神经纤维自身上受体相互作用的反应。
现有文献中已经观察到神经系统会维持信号的平衡,所述信号是由交感神经和副交感神经传递的。迷走神经,作为向收缩支气管平滑肌和/或心肌提供信号的源头,其被认为提供在心肌和围绕支气管通道平滑肌内的张力基线水平,用于:(i)阻止沿导气管排列的组织塌陷关闭;和/或(ii)阻止组织过度扩张和抑制血压。
特别地,本发明的一个或多个具体方案认为由迷走(副交感)神经传递的信号引起:(i)围绕支气管通道的平滑肌收缩,和/或(ii)减慢心率。交感神经纤维传递相反的信号,趋于打开支气管通道和加速心率。可以认为,迷走神经的信号调节类似于组胺的反应,而交感神经信号产生类似于肾上腺素的作用。考虑到在副交感神经和交感神经信号之间的假定平衡,移除副交感神经信号将建立一种加强了交感神经信号的不平衡。按此方式,科学文献还表明切断狗的迷走神经将升高动物的心率和打开支气管通道,与肾上腺素的作用方式基本相同。
现在参考图1和2,更详细的显示了迷走神经。迷走神经由运动和感觉纤维组成。迷走神经离开头部,并与副神经包含于相同的硬膜鞘中。迷走神经在颈动脉鞘内沿颈向下传到颈根部。迷走神经分布的分支包括,尤其是上心支、下心支、前支气管支和后支气管支。在右侧,迷走神经沿气管下降到肺根后部,在这里其散布到后肺丛中。在左侧,迷走神经进入胸部,穿过主动脉弓的左侧,并在左肺根的后面下降,形成后肺丛。
在哺乳动物中,在脑干中已经进化出两个迷走神经部分以控制周围副交感神经的功能。背迷走神经复合体(DVC),由背运动核(DMNX)和其连接物组成,控制低于膈膜水平的副交感神经的功能,而腹迷走神经复合体(VVC),由疑核和面神经后核组成,控制膈膜上器官内的功能,例如心脏、胸腺和肺,以及颈和上胸部的其他腺体和组织,和特定的肌肉例如食管复合体的那些。
迷走神经的副交感神经部分支配节神经元,所述节神经元位于或邻近于各个靶器官。所述腹迷走神经复合体看来仅存在于哺乳动物中,并联系到与兴奋状态相关的正向以及负向调节心率、支气管收缩、发声和面部肌肉的收缩。一般而言,所述迷走神经部分控制副交感神经的状态。在警惕状态,所述腹迷走神经复合体的抑制被解除(关闭)。这依次导致心脏迷走紧张度的减少和导气管的打开,以支持对环境挑战的反应。
部分的副交感神经张力被交感神经支配来平衡,其一般而言提供趋于扩张心肌、影响血管收缩和/或松驰支气管肌肉的信号,因此不分别发生过度收缩和过度压抑。整体上,心肌张力、血管舒张和/或导气管平滑肌紧张度取决于几个因素,包括副交感神经的输入、循环中肾上腺素的抑制作用、非肾上腺素能非胆碱能抑制神经和副交感神经节的交感神经支配。迷走神经的兴奋(张力的上调),例如在休克中发生的,导致心率下降和导气管收缩。在本文中,上调是特定作用被增加的过程,而下调包括作用的降低。通常,休克的病理看起来是通过炎性细胞因子介导的,所述炎性细胞因子压制在神经细胞上的受体,并导致细胞整体上调副交感神经的张力。在细胞水平上,上调是细胞增加其对给定激素或神经递质受体的数目来改善其对这些分子敏感性的过程。受体的减少被称为下调。
过敏反应看起来主要由对变态反应原的超敏反应来介导,导致大量胆碱能受体活化细胞因子的生产过剩,所述细胞因子过度驱使本应正常操作的迷走神经发出大量的导气管收缩信号。
就哮喘(其可能会涉及过敏反应)来说,看来好像导气管组织兼备(i)对导致过量生产细胞因子的变态反应原的超敏反应,所述细胞因子刺激神经的胆碱能受体,和/或(ii)当碰到任意水平的胆碱能细胞因子时,有高基线的副交感神经张力或高增幅至强副交感神经张力。这种组合可以是致命的。
败血症由严重的感染介导,并可以引起大规模的炎症反应、增加毛细血管渗透性、降低体循环血管阻力和低血压,所述炎症反应释放细胞因子TNFα、IL-1β、IL-6介导的血管剧烈舒张。比较起来,过敏反应看起来主要由对变态反应原的超敏反应来介导,导致大量胆碱能受体活化细胞因子的生产过剩,所述细胞因子过度驱使本应正常操作的迷走神经发出大量的导气管收缩信号。药物例如肾上腺素驱使心率上升,同时还松弛支气管肌肉,用于暂时减轻这些状况下的症状。
药物例如肾上腺素驱使心率上升,同时还松弛支气管肌肉,用于暂时减轻这些状况下的症状。如上所述,经验显示切断迷走神经(减少副交感神经张力的极端方案)具有类似于肾上腺素对心率和支气管直径的作用,即心脏开始疾弛(心动过速)和支气管通道扩张。
根据本发明的至少一个方面,在患有过敏反应、过敏性休克、支气管收缩、哮喘等等的病人中,沿迷走神经给予足够阻断和/或调节信号传送的电脉冲将导致支气管平滑肌的松弛、扩张导气管、提升心脏功能(和从而血压)、和/或抵消过敏反应和/或组胺在迷走神经上的作用。取决于脉冲的位置,阻断和/或调节信号还可以提升心脏功能。
根据本发明的至少一个方面,阻断和/或调节迷走神经中的信号,和/或阻断和/或影响迷走神经的过敏反应或组胺反应,以减少副交感神经张力提供直接的紧急反应,非常象心脏除颤器,在过敏反应、过敏性休克、支气管收缩、哮喘等等的状况中,提供直接临时的导气管扩张和/或心脏功能增加直至可以使用后续的措施,例如给予药物、人工呼吸和插管。此外,本发明的教导给予了快速的导气管扩张和/或心脏功能提升以使后续的救生方法成为可能,否则由于严重的收缩或其他生理作用后续的救生方法将是无效的或不可能的。根据本发明的治疗提供了足够长时间的支气管扩张和/或心脏功能增加,以便在病人窒息前,有时间使给予的药物(例如肾上腺素)治疗起效。
这里描述的向迷走神经的选择区域施用电脉冲的方法可以进一步细化,即至少一个区域可以包含至少一个源于病人第十对脑神经(迷走神经)的神经纤维(迷走神经),和特别是,至少一个其支气管前支、至少一个其支气管后支、至少一个其心上支、和/或至少一个其心下支。优选,沿肺的外部定位,脉冲被提供到至少一个前肺丛或后肺丛。根据需要,脉冲可以被导向仅支配支气管树和肺组织本身的神经。另外,脉冲可以被导向迷走神经的区域以阻断和/或调节心脏和支气管支的一个或两个。如同本领域技术人员所认识的,在已知具有心脏问题的病人中使用这个具体方案前将被仔细的评估。
对于心脏支,心丛位于心脏的基底部,和被分为表面部分和深位部分,所述表面部分位于主动脉弓的凹处,所述深位部分在主动脉弓和气管之间。然而,这两个部分是非常紧密连接的。心丛的表面部分位于主动脉弓之下,在右肺动脉之前。其由左交感神经的心上支和左迷走神经的颈心上支的下部形成。心丛的表面部分发出分支(a)至丛的深位部分;(b)至前冠状动脉丛;和(c)至左前肺丛。心丛的深位部位位于气管分叉的前面,在肺动脉的分支点之前和主动脉弓之后。其由源自交感神经颈神经节的心神经、和迷走神经和回归神经的心脏支形成。唯一没有参加形成心丛深位部位的心神经是左侧交感神经的心上神经、和来自左侧迷走神经的两个颈上心支的下部,其传到丛的表面部分。
进一步参考图3,其图解了显示于图2中的迷走神经和其心脏和肺支的简单视图。还显示了迷走神经刺激(VNS)装置300,用于刺激迷走神经。迷走神经刺激装置300计划用于过敏反应、过敏性休克、支气管收缩、哮喘、低血压等等的治疗。迷走神经刺激装置300可以包括电脉冲发生器310;与电脉冲发生器310连接在一起的电源320;与电脉冲发生器310相联系并与电源320连接在一起的控制单元330;和与电脉冲发生器310连接在一起的电极340,用于通过导线350附着到哺乳动物的迷走神经200的一个或多个选择区域200A、200B。所述控制单元330可以控制电脉冲发生器310,用于产生适合改善,例如,支气管收缩或血压过低的信号,这时是将信号通过电极340向迷走神经200应用。应注意到,通过其作用,迷走神经刺激装置300可以被指为脉冲发生器。
根据一个具体方案,一个或多个电脉冲被导向位点A,所述位点A在心脏支上面的迷走神经之上或附近。在这个具体方案中,一个或多个电脉冲被引入位点A以阻断和/或调节和/或抑制副交感神经张力的上调,并影响导气管的扩张及增加心脏功能。
根据另一个具体方案,一个或多个电脉冲被导向位点B,所述位点B在临近肺支的心脏支下方的迷走神经之上或附近。在这个具体方案中,一个或多个电脉冲被引入位点B以阻断和/或调节和/或抑制副交感神经张力的上调,来仅作用于导气管的扩张。
在已知患有过敏性休克或严重哮喘发作的病人中,一个或多个电脉冲发生装置300可以被植入迷走神经200的一个或多个选择的区域200A、200B。装置300可以经皮用于紧急应用,其中装置300可以包含由外部电源320供电的电极340。
美国专利申请公开2005/0075701和2005/0075702,两者都是Shafer的,两者都在此引入作为参考,涉及刺激交感神经系统的神经元以弱化免疫反应,包括了可能适用于本发明的脉冲发生器的描述。
图4图解了根据本发明的一个具体方案,一个典型的用于阻断和/或调节脉冲的电压/电流分布图,所述脉冲被应用到迷走神经的一个或多个部分。可以利用脉冲发生器310实现一个合适的用于阻断和/或调节脉冲410的电压/电流分布图400,所述脉冲410被应用到迷走神经200的一个或多个部分200A、200B。在一个优选的具体方案中,可以使用电源320和控制单元330来运行脉冲发生器310,所述控制单元330具有,例如,处理器、时钟、存贮器等等,向电极340产生脉冲串420,所述电极340经由导线350向神经200传递阻断和/或调节脉冲410。对于经皮的应用,迷走神经刺激装置300可以让外科医生作为外部应急装置。对于皮下应用,迷走神经刺激装置300可以是外科植入的,例如在腹部的皮下袋中。迷走神经刺激装置300可以是从身体外部供电和/或充电或者可以具有自身的电源320。举例来说,迷走神经刺激装置300可以通过商业上购买。优选,迷走神经刺激装置300由医生程序员来编程,例如可以从Medtronic,Inc.获得的型号7432。
调节信号400的参数优选是可编程的,例如频率、振幅、作业周期、脉冲宽度、脉冲波形等等。就植入脉冲发生器来说,可以在植入之前或之后编程。例如,植入脉冲发生器可以具有一种用于与发生器的设定相沟通的外部设备。外部通信装置可以改变脉冲发生器的编程以改善治疗。
优选,选择电导线350和电极340以达到各自的容许脉冲峰值电压的阻抗,所述脉冲峰值电压在约0.2伏特到约20伏特的范围内。
所述阻断和/或调节脉冲信号410优选具有被选择的影响治疗结果的,即阻断和/或调节部分或全部迷走神经传输的,频率、振幅、作业周期、脉冲宽度、脉冲波形等等。例如,频率可以是约1Hz或更大,例如在约25Hz到3000Hz之间,或在约1000Hz到约2500Hz之间。(与典型的神经刺激或调节频率相比,这是显著的更高的频率。)调节信号可以具有被选择的影响治疗结果的脉冲宽度,例如约20μS或更大,例如约20μS至约1000μS。调节信号可以具有选择的影响治疗结果的峰值电压振幅,例如约0.2伏特或更大,例如约0.2伏特至约20伏特。
根据优选的具体方案,根据本发明的迷走神经刺激装置300以经皮方式或可以被个体再次使用的皮下植入方式来提供。
根据另一个具体方案,根据本发明的装置以“起搏器”的类型形式提供,其中通过迷走神经刺激装置300对迷走神经200的选择区域200A、200B在周期性的基线上产生电脉冲410,以在病人中对上调信号创建迷走神经200的低反应性。
根据另一个具体方案,根据本发明的装置300被合并入一种气管内导管装置中以在外科手术期间改善支气管痉挛。在一个优选的具体方案中,一个或多个装置300位于气管内导管的远侧部以与迷走神经200的选择区域200A、200B相接触,来给予适当的电脉冲以缓和迷走神经200对刺激的反应。然而,对永久植入的所有情况来说,植入外科医生应当改变由控制单元330调节的信号和导线350的特定定位,直到实现期望的结果,并应当监视这个作用的长期维持状况,以确保病人身体的适应机制不会取消预期的效果。
另外,或者作为对执行调节单元功能装置的替代,所述调节单元用于向电极产生阻断和/或调节脉冲的电压/电流分布图,在美国专利公开号:2005/0216062(其全部公开内容在此全文引入作为参考)公开的装置可以被使用。美国专利公开号:2005/0216062公开了一种多功能电刺激(ES)系统,适合产生用于影响感应电流、电磁或其他形式用于许多不同生物学和生物医学应用的电刺激的输出信号。系统包括一个具有选择器的电刺激信号平台,所述选择器与大量不同信号发生器连接在一起,所述信号发生器每个都产生具有不同形状的信号,例如正弦、方形、锯齿波或简单的或复合的脉冲,其参数按照振幅、持续时间、重复率及其他变量来调节。来自于电刺激平台中的选择发生器的信号被供应给至少一个输出平台,所述输出平台处理信号以产生具有期望极性的高或低的电压或电流,借此输出平台能够产生适合于其目标应用的电刺激信号。还包括在系统中的有测量平台,其测量和显示运行在受治疗实体上的电刺激信号以及各种传感器的输出值,所述传感器感知在这个实体中优势的状况,借此系统的使用者可以手动的调整系统或让系统通过反馈自动调整,以提供他希望的任何类型的电刺激信号,并且使用者能因此观察到信号在被治疗的实体上的作用。
在讨论实验结果之前,根据本发明的一个或多个具体方案,治疗过敏反应、过敏性休克、支气管收缩、哮喘、低血压等等的一般方法可以包括向需要减轻过敏反应的哺乳动物的迷走神经的一个或多个选择区域施用至少一个电脉冲。
所述方法可以包括:向迷走神经的选择区域植入一个或多个电极;和向电极施用一个或多个电刺激以产生至少一个电脉冲,其中所述一个或多个电刺激信号具有在约1Hz到3000Hz之间的频率和在约1-6伏特之间的振幅。
所述一个或多个电刺激信号可以具有在约750Hz到1250Hz之间的频率;或在约10Hz到35Hz之间的频率。所述一个或多个电刺激信号可以具有在约0.75到1.5伏特之间,例如约1.25伏特的振幅。所述一个或多个电刺激信号可以是一个或多个完整或部分的正弦曲线、方波、矩形波和/或三角形波。所述一个或多个电刺激信号可以具有在约50到500微秒之间的脉冲持续时间,例如约100、200或400微秒。
脉冲的极性可以保持在或者正或者负。可选择的,脉冲的极性可以是波的一段时间为正和波的另一段时间为负。举例来说,脉冲的基线可以约每隔一秒改变。
虽然上调由交感神经提供的信号可以完成期望的治疗效果,本发明建议立即阻断过敏反应、过敏性休克、支气管收缩、哮喘、低血压等等的循环的更直接的途径是经由迷走神经,因为对于超敏反应的作用方式是在迷走神经而非通过交感神经。因此,进行实验以识别怎样将电信号提供给周围神经纤维的典型方法,所述周围神经纤维支配和/或控制支气管平滑肌以(i)减少肌肉对收缩信号的敏感性,和(ii)一旦已经开始收缩则减弱收缩的强度或阻断收缩。另外,进行实验以识别怎样将电信号提供给周围神经纤维的典型方法,所述周围神经纤维支配和/或控制血管收缩/扩张,和/或支配和/或控制心肌以(i)减少肌肉对紧张性收缩信号的敏感性,和(ii)一旦已经开始则减弱其强度或阻断紧张性过度收缩。
特别是,选自已知神经信号范围内的特定信号被施用到豚鼠的迷走神经和/或交感神经,以产生对肺迷走神经活性的选择性阻断或减少,导致过敏反应诱导的支气管收缩和/或低血压的减弱。
实验
与用静脉注射组胺诱导的低血压和/或支气管收缩试验相反,下面的试验方法和试验数据是根据过敏反应获得的。十五只雄性豚鼠(400g)通过腹膜内注射卵清蛋白(每48小时10mg/kg腹膜注射,三次)来致敏。三星期后,动物被运输到实验室并立即用腹腔注射乌拉坦1.5g/kg麻醉。前颈上的皮肤被打开,并分别在颈动脉和两个颈静脉用PE50管插管,以允许血压/心率监测和给药。气管被插管,和通过正压、等容通气为动物换气,随后用琥珀胆碱(10ug/kg/min)麻痹以使胸壁肌肉系统麻痹来去除胸壁刚性对导气管压力测量的影响。两个迷走神经被分离和连接到保护电极,以允许按前述一个或多个具体方案中公开的方式来选择性的刺激这些神经。在稳定十五分钟后,在给予增加浓度的卵清蛋白(0.001-1.0mg/kg,静脉注射)之前和之后进行基线血液动力学和导气管压力的测量。在过敏反应伴随的导气管压力升高和低血压之后,在改变的频率、电压和脉冲持续时间来作出迷走神经的神经调节,以识别减弱低血压和支气管收缩反应的参数。用静脉注射氯化钾来完成安乐死。
对于图5,顶部的线(BP)显示血压、第二个线显示导气管压力(AP1)、第三个线显示在另一个传感器上的导气管压力(AP2),第四个线是来源于血压中脉冲的心率(HR)。作为在这个模型中获得的过敏反应的基线,没有施加任何电刺激的第一个豚鼠对卵清蛋白的反应被记录。图20显示了注射0.75mg卵清蛋白的作用。在注射之后大约五分钟,血压从125mmHg降低到50mmHg,而导气管压力从11增加到14cm H2O.这种作用维持超过六十(60)分钟,同时血压显示部分回复至90mmHg。
对于图6,另一个动物(豚鼠#2)被测试以确定信号的作用,所述信号在组胺诱导的哮喘模型中显示有效性(上述实验方法1)。图21表明了在致敏豚鼠#2被注射1.125mg卵清蛋白导致过敏反应后,同时向致敏豚鼠#2的左和右迷走神经两者应用25Hz、200μS、1.25V的矩形波信号的作用。更大的剂量被用于引起更严重的反应。从图的左侧开始,可见在电刺激之前,血压严重的下降到30mmHg而导气管压力几乎是22cm H2O(比基线增加9.5cm)。血压中的第一个峰与应用到迷走神经的电信号相符-血压增加到60mmHg(100%的增加),而导气管压力被降低6.5cm至约15.5cm H2O(68%的降低)。下一个峰显示了重复的作用。其他峰显示了改变的信号电压的作用-降低电压导致有效性的降低。
对于图7,显示了改变的信号频率和脉冲宽度在血压和导气管压力上的作用。血压中的第一个峰与应用到两侧迷走神经的15Hz、300μS、1.25V的电信号相符-血压增加到60mmHg(70%的增加),而导气管压力被降低减少了1.5cm至约17cm H2O(25%的降低)。下一个峰表明了10Hz的信号-与15Hz的相比有益作用被减少了。其他峰显示了改变的信号频率和脉冲宽度的作用-降低频率低于15Hz或降低脉冲宽度低于200μS导致了有效性的降低。在15-25Hz和200-300μS之间的信号在减少过敏反应的低血压和支气管收缩症状中维持大致一样的有效性。
可以从上述实验数据得出的结论包括:(1)在豚鼠中由过敏反应引起的导气管收缩和低血压,可以被显著的通过向迷走神经应用合适的电信号来降低。(2)从15Hz至25Hz、200μS至300μS和1.0V至1.5V的信号有相同的有效性。(3)向迷走神经应用25Hz、200μS、1.25V的信号,源于过敏反应的导气管收缩被降低直至68%。这种作用已经在几个动物上被重复。(4)在经历严重低血压的过敏性豚鼠内,向迷走神经应用的25Hz、200μS、1.25V的信号在血压中产生了直至100%的增加。这种作用已经在几个动物上被重复。这可以应用于其他低血压状况例如脓毒性休克的治疗。(5)这里有一些证据,向迷走神经应用信号可以有缩短过敏反应急性发作持续时间的能力。
虽然本发明参照特定的具体方案已经进来了描述,可以理解这些具体方案仅仅用于说明本发明的原则和应用。因此可以理解,在不偏离通过权利要求定义的本发明精神和范围时,可以对说明性的具体方案作许多修改和可以设计其他方案。
Claims (20)
1、一种治疗过敏反应的方法,包括向需要减轻过敏反应的哺乳动物的迷走神经的至少一个选择区域施用至少一个电脉冲,以此达到调节哺乳动物心脏组织肌纤维、血管收缩和哺乳动物支气管肌纤维中至少一个的作用。
2、如权利要求1所述的方法,其中至少一个选择区域包括邻近迷走神经心脏支和支气管支中至少一个的迷走神经区域。
3、如权利要求2所述的方法,其中作用包括至少一个:
改善心肌性能,包括增加心脏功能;
增加血压;
维持稳定的心率;
影响血管收缩/扩张;
增加开放支气管的导气管;和
减少支气管痉挛。
4、如权利要求3所述的方法,其中迷走神经的至少一个选择区域包括一个或多个:
迷走神经的心脏上和/或下支;
迷走神经的支气管前和/或后支;
迷走神经的右支,
迷走神经的左支;
在冠状动脉的前或后丛之上或附近;和
在肺的前或后丛之上或附近。
5、一种用于治疗过敏反应的装置,包括:
电脉冲发生器;
与电脉冲发生器连接在一起的电源;
与电脉冲发生器相通信和与电源连接在一起的控制单元;
与电脉冲发生器连接在一起的电极;和
与电极连接的用于附着在哺乳动物迷走神经的一个或多个选择区域的电极导线;
其中所述控制单元可操作地调节电脉冲发生器,用于产生当将信号通过电极导线向迷走神经应用时适于治疗过敏反应和/或相关并发症的信号。
6、如权利要求5所述的装置,其中电极导线具有宽的接触面积。
7、一种治疗过敏反应、过敏性休克、支气管收缩和/或哮喘的方法,包括向需要减轻的哺乳动物的迷走神经的一个或多个选择区域应用至少一个电脉冲。
8、如权利要求7所述的方法,进一步包括:
向迷走神经的选择区域植入一个或多个电极;和
向电极应用一个或多个电刺激信号,以产生至少一个电脉冲。
9、如权利要求8所述的方法,其中所述一个或多个电刺激信号具有在约1Hz至3000Hz之间频率,和在约1-6伏特之间的振幅。
10、如权利要求9所述的方法,其中所述一个或多个电刺激信号具有在约750Hz至1250Hz之间的频率。
11、如权利要求9所述的方法,其中所述一个或多个电刺激信号具有在约10Hz至35Hz之间的频率。
12、如权利要求9所述的方法,其中所述一个或多个电刺激信号具有在约0.75至1.5伏特之间的振幅。
13、如权利要求9所述的方法,其中所述一个或多个电刺激信号是一个或多个完整或部分的正弦波、方波、矩形波、三角形波。
14、如权利要求9所述的方法,其中所述一个或多个电刺激信号具有在约50至500微秒之间的脉冲工作时间。
15、如权利要求9所述的方法,其中所述一个或多个电刺激信号具有约25Hz的频率,约200-400微妙的脉冲工作时间和约1伏特的振幅。
16、如权利要求9所述的方法,其中所述一个或多个电刺激信号具有约25Hz的频率,在约100至400微妙之间的脉冲工作时间和约1伏特的振幅。
17、如权利要求16所述的方法,其中所述脉冲工作时间是:约400微秒、约200微秒和约100微秒之一。
18、如权利要求9所述的方法,进一步包括维持脉冲的极性为正或负。
19、如权利要求18所述的方法,进一步包括交变脉冲的极性为波的一段时间是正和波的另一段时间是负。
20、如权利要求18所述的方法,进一步包括约每隔一秒交变脉冲的极性。
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Cited By (3)
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CN111419179A (zh) * | 2013-11-07 | 2020-07-17 | 赛佛欧普手术有限公司 | 检测神经功能的系统 |
CN111419179B (zh) * | 2013-11-07 | 2023-04-07 | 赛佛欧普手术有限公司 | 检测神经功能的系统 |
CN106821357A (zh) * | 2016-11-18 | 2017-06-13 | 温州芳植生物科技有限公司 | 一种针对肌强直、肌痉挛病人的防摔装置 |
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US20070191902A1 (en) | 2007-08-16 |
US7869880B2 (en) | 2011-01-11 |
US7711430B2 (en) | 2010-05-04 |
WO2007092062A1 (en) | 2007-08-16 |
US8483835B2 (en) | 2013-07-09 |
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