CN101489624A - 用于多脉管肾神经调制的方法和装置 - Google Patents

用于多脉管肾神经调制的方法和装置 Download PDF

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CN101489624A
CN101489624A CNA2007800271980A CN200780027198A CN101489624A CN 101489624 A CN101489624 A CN 101489624A CN A2007800271980 A CNA2007800271980 A CN A2007800271980A CN 200780027198 A CN200780027198 A CN 200780027198A CN 101489624 A CN101489624 A CN 101489624A
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electrode
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kidney
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丹尼丝·德马雷
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Medtronic Ardian Luxembourg SARL
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Ardian Inc
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Abstract

本发明提供例如经由脉冲电场进行多脉管神经调制的方法和装置。这样的多脉管神经调制可以实现不可逆的电穿孔或电融合，坏死和/或细胞凋亡的诱导，基因表达的改变，动作电位衰减或阻断，细胞因子上调及在目标神经纤维中的其它条件的改变。在一些实施方案中，将所述多脉管神经调制施用到促进肾功能的神经纤维。这样的多脉管神经调制任选地可以双侧进行。

Description

用于多脉管肾神经调制的方法和装置
相关申请参考
[0001]本申请是共同未决的2005年5月13日提交的美国专利申请号11/129,765的部分继续申请，所述美国专利申请号11/129,765要求2004年10月5日提交的美国临时申请号(a)60/616,254和2004年11月2日提交的美国临时申请号(b)60/624,793的权益。
[0002]全部这些申请通过参考全部结合于此。
通过参考的结合
[0003]本说明书中提到的全部出版物和专利申请通过参考结合于此，达到好像每个单独的出版物或专利申请具体地并独立地表明是通过参考结合的程度。
技术领域
[0004]本发明涉及用于神经调制的方法和装置。在一些实施方案中，本发明涉及用于实现肾神经调制的方法和装置。
背景技术
[0005]充血性心力衰竭(＂CHF＂)是一种病症，在当心脏被损伤并且到达身体器官的血流量减少时发生所述病症。如果血流量充分降低，则肾功能被改变，其导致流体潴留、失常的激素分泌和增加的血管收缩。这些结果增加心脏的工作负荷并且进一步降低心脏泵送血液经过肾和循环系统的能力。
[0006]相信渐进性减少肾的灌注是维持CHF螺旋向下的主要非心脏原因。而且，由这些生理性改变产生的流体超载和有关的临床症状导致另外的住院、差的生活品质和对于健康护理系统的额外成本。
[0007]除它们在CHF的进行中的作用外，肾在慢性肾衰竭(“CRF”)、晚期肾病(“ESRD”)、高血压(病理性高血压)及其它心肾病的进行中起显著的作用。肾的功能可以概述在三个广泛的类别下：过滤血液和排泄由身体的代谢产生的废产物；调节盐、水、电解质和酸-碱平衡；和分泌激素以保持重要器官的血流量。在不适当行使肾功能的情况下，患者将遭受水潴留、减少的尿流量和废物毒素在血液和身体中的积累。这些病症是由于降低的肾功能或肾衰竭(肾衰竭)引起的并且被认为增加心脏的工作负荷。在CHF患者中，肾衰竭将引起心脏进一步恶化，因为不良运行肾而引起流体被潴留并且血液毒素积累。
[0008]已经在动物模型中确定了心力衰竭病症导致异常高的肾交感神经激活。这样高水平的肾交感神经活性导致从身体除去的水和钠减少，以及肾素分泌增加。增加的肾素分泌导致供应肾的血管的血管收缩，其引起肾血流量降低。例如，通过去神经，降低交感肾神经活性，可以逆转这些过程。
[0009]申请人以前已经描述了通过将脉冲电场施加到促进肾功能的神经纤维而用于治疗肾脏病症的方法和装置。见，例如，申请人于2005年5月13日提交的共同未决的美国专利申请序号11/129,765和2005年7月25日提交的共同未决的美国专利申请序号11/189,563，将其二者都通过参考全部结合于此。脉冲电场(＂PEF＂)可以经由不可逆电穿孔、电融合或其它过程引发去神经化或其它的肾神经调制。PEF可以从定位在血管内的、血管外的、血管内到外的、或其组合的装置递送。例如，在2003年4月8日提交的共同所有和共同未决美国专利申请序号10/408,665和美国专利号6,978,174中描述了经由局部药物递送(比如通过药物泵或输液导管)，刺激电场，或其它形式用于实现肾神经调制的另外的方法和装置，将这二者参考文献通过参考全部结合于此。
[0010]电融合一般指的是通过暴露到电场而诱导相邻细胞的融合。用于电融合目的的目标相邻细胞之间的接触可以以多种方式实现，包括，例如，经由介电电泳。在组织中，所述目标细胞可以已经是在接触状态，因而有利于电融合。
[0011]电穿孔和电渗透一般指的是操作细胞膜或细胞内装置的方法。例如，细胞膜的孔隙率可以通过经由短的高压脉冲跨越细胞膜诱导足够的电压而增加。细胞膜中孔隙率的程度(例如，孔隙的尺寸和数量)和作用的持续时间(例如，暂时的或永久的)是多种变量的函数，例如场强、脉冲宽度、工作循环、电场取向、细胞类型或尺寸和/或其它参数。
[0012]在相对较低强度的电场或相对较短的脉搏宽度终止时，细胞膜孔隙一般将自发地关闭(这里称为“可逆的电穿孔”)。然而，每个细胞或细胞类型具有临界阈值，超过所述临界阈值孔隙不关闭以致孔形成不再是可逆性的；将该结果定义为“不可逆的电穿孔”，“不可逆的击穿”或“不可逆的损伤”。此时，发生由高孔隙率所引起的细胞膜破裂和/或不可逆的化学不平衡。这样的高孔隙率可以是单个大孔和/或多个较小孔的结果。
[0013]使用血管内PEF体系用于治疗肾脏病症的潜在挑战是在不影响其它细胞的情况下选择性电穿孔目标细胞。例如，合乎需要的是不可逆电穿孔沿着或接近于肾脉管系统行进的肾神经细胞，但是不合需要的是损伤其中构成脉管系统的平滑肌细胞。结果，过度激进的PEF治疗过程可能永久性地损害肾脉管系统，但是过度保守的PEF治疗过程可能不能实现所需的肾神经调制。
[0014]申请人已经在前描述了用于监视组织阻抗或电导率以确定脉冲电场治疗效果的方法和装置，例如，确定电穿孔的程度和/或它的不可逆程度。见，例如，申请人于2005年9月23日的共同未决美国专利申请序号11/233,814，将其通过参考全部结合于此。组织的脉冲电场电穿孔引起组织阻抗减小和组织电导率增加。如果引起的电穿孔是可逆性的，则在中止脉冲电场时，组织阻抗和电导率应当接近基线水平。然而，如果电穿孔是不可逆的，则在终止脉冲电场以后，阻抗和电导率改变应当持续。因而，监视目标和/或非目标组织的阻抗或电导率可以用于确定电穿孔的起始并且确定电穿孔的类型或程度。而且，监视数据可以用在一个或多个手动或自动反馈回路中以控制所述电穿孔。
[0015]鉴于上述，合乎需要的是提供另外的用于实现肾神经调制的方法和装置。
附图简述
[0016]在考虑下列详细说明连同附图时，本发明的数个实施方案将是显而易见的，其中相同的附图标记始终表示相同的部分，并且其中：
[0017]图1是图解人肾解剖学的示意图。
[0018]图2是显示肾神经相对于肾动脉的位置的示意性等比例的详细视图。
[0019]图3A和3B分别是示意性等比例视图和端视图，图解用于选择性影响肾神经的电场取向。
[0020]图4是示意性侧视图，部分以截面形式，图解了用于肾神经调制的多脉管方法和装置的实例。
[0021]图5A和5B是示意性侧视图，部分以截面形式，图解用于肾神经调制的多脉管方法和装置的其它实例。
[0022]图6是示意性侧视图，部分以截面形式，图解使用用于多脉管肾神经调制的图5A的装置的另一种方法。
[0023]图7A和7B是示意性顶视图，部分以横截面形式，图解用于肾神经调制的多脉管方法和装置的另外的实例。
[0024]图8是示意性顶视图，部分以横截面形式，图解用于评价肾儿茶酚胺溢出的图7的装置的实施方案。
[0025]图9是示意性顶视图，部分以横截面形式，图解包括重叠双极电场的肾神经调制用的多脉管方法和装置的实例。
发明详述
A.综述
[0026]本发明的方法和装置可以用于调制促进肾功能的神经纤维，并且可以开发将实现所需神经调制的任何适合的神经调制技术。本发明的数个实施方案是通过下列各项用于神经调制的方法和装置：脉冲电场(＂PEF＂)，刺激电场，局部药物递送，高频率超声，热技术，无热技术，它们的组合，和/或其它技术。例如，神经调制可以实现不可逆的电穿孔或电融合，坏死和/或诱导细胞凋亡，改变基因表达，动作电位阻断或衰减，细胞因子上调及目标神经纤维中的其它条件的改变。在数个实施方案中，神经调制通过具有神经调制元件的多脉管方法和装置来实现，所述神经调制元件定位在多个脉管之内和/或单个脉管的多个分支之内。
[0027]在一些患者中，当本发明的多脉管神经调制方法和装置应用于促进肾神经功能的肾神经和/或其它神经纤维时，申请人相信神经调制可以直接或间接增加尿输出，降低血浆肾素水平，减少组织(例如，肾)和/或尿儿茶酚胺，引起肾儿茶酚胺(例如，去甲肾上腺素)溢出，增加泌尿系统的钠分泌，和/或控制血压。而且，申请人相信这些或其它改变可以预防或治疗充血性心力衰竭、高血压、急性心肌梗塞、晚期肾病、造影剂肾病、其它肾脏系统疾病，和/或其它肾或心-肾异常。这里所描述的方法和装置可以用于调制传出的和/或传入的神经信号。
[0028]肾神经调制优选地以双侧方式进行，以便对右肾和左肾的肾功能起作用的神经纤维都被调制。与单侧进行的肾神经调制相比，即，与在支配单个肾神经的神经组织上进行的肾神经调制相比，双侧肾神经调制可以在一些患者中提供增强的治疗效果。在一些实施方案中，可以实现促进右肾和左肾功能的神经纤维的同时调制；而在其它实施方案中，右神经纤维和左神经纤维的调制可以是顺序的。依照要求，双侧肾神经调制可以是连续的或间歇的。
[0029]当使用电场实现所需的肾神经调制时，可以以任何适合的组合改变和组合电场参数。这样的参数可以包括，但不限于，电压，场强，频率，脉冲宽度，脉冲持续时间，脉冲形状，脉冲数量和/或脉冲之间的时间间隔(例如，工作循环)，等。例如，当使用脉冲电场时，适合的场强可以高达约10,000V/cm并且适合的脉冲宽度可以高达约1秒。适合的脉冲波形形状包括，例如，AC波形、正弦波形、余弦波形、正弦和余弦波的组合、DC波形、DC-变换的AC波形、RF波形、直角波、梯形波、指数衰减波、或组合。所述场包括至少一个脉冲，并且在许多应用中所述场包括多个脉冲。适合的脉冲间隔包括，例如，小于约10秒的间隔。将这些参数提供为适合的实例并且决不应该认为是限制性的。
[0030]为了更好理解本发明的装置的结构和使用这样的装置用于肾神经调制的方法，有益的是检验在人中的肾脏解剖学。
B.用于神经调制方法所选择的实施方案
[0031]现在参考图1，人肾脏解剖学包括通过肾动脉RA提供充氧血液的肾K，将其通过腹主动脉AA连接到心脏。去氧的血液通过肾静脉RV和下腔静脉IVC从肾流到心脏。图2以更具体地图解了肾解剖学的一部分。更具体而言，肾解剖学还包括肾神经RN，所述肾神经RN一般沿着肾动脉RA的纵向尺寸L纵向延伸，一般在动脉的外膜内。肾动脉RA具有一般围绕动脉周围并且围绕动脉的倾斜的轴θ螺旋的平滑肌细胞SMC。肾动脉的平滑肌细胞因此具有纵长的或更长的尺寸，其相对横向(即，非平行)于肾动脉的纵向尺寸延伸。肾神经和平滑肌细胞的纵向尺寸的未对准规定为“细胞未对准”。
[0032]参考图3A和3B，肾神经和平滑肌细胞的细胞未对准任选可以被利用以选择性地影响肾神经细胞，对于平滑肌细胞具有减小的作用。更具体而言，因为较大的细胞需要较低的电场强度以超过对于不可逆电穿孔的细胞膜不可逆性阈值电压或能量，所以本发明的实施方案任选可以配置成将至少一部分电场与要影响的细胞的较长尺寸对准或接近。在具体的实施方案中，所述装置具有定位在不同脉管中并且配置成产生电场的双极电极对，所述电场与肾动脉RA的纵向尺寸L对准或接近，以优先影响肾神经RN。通过对准电场以便所述场优先与细胞的纵向方面对准而不是与细胞的直径或径向方面对准，可以将较低的场强用于影响目标神经细胞，例如，用于使所述目标细胞坏死或融合，用于诱导细胞凋亡，用于改变基因表达，用于消弱或阻滞动作电位，用于改变细胞因子上调和/或用于诱导其它的适合过程。预期这将减少递送到所述系统的总能量，并且减轻电场中对于非目标细胞的影响。
[0033]类似地，在所述目标神经上或下的组织的纵向尺寸或较长的尺寸相对于神经细胞的较长尺寸是正交的或以另外方式离轴的(例如，横切)。因而，除了将脉冲电场(“PEF”)与目标细胞的纵向或较长的尺寸对准之外，PEF可以沿着非目标细胞的横向或较短的尺寸传播(即，因此PEF至少部分地不与非目标平滑肌细胞SMC对准传播)。因此，如图3A和3B中所示，应用具有传播线Li的PEF，预期将优先引起目标肾神经RN的细胞中的电穿孔(例如，不可逆电穿孔)，电融合或其它神经调制，而不过度影响非目标动脉平滑肌细胞SMC，所述传播线Li一般与肾动脉RA的纵向尺寸L对准。脉冲电场可以沿着肾动脉的纵轴在单个平面中传播，或可以沿着0°-360°范围内的任何角度(angular segment)θ在纵向上传播。
[0034]放置在肾动脉的壁之内和/或接近肾动脉的壁的PEF系统可以传播具有纵向部分的电场，将所述纵向部分对准以随着肾神经RN和血管壁的平滑肌细胞SMC的区域中动脉的纵向尺寸运行，以便在外部神经细胞被破坏、融合或以另外方式被影响时所述动脉的壁至少基本上保持完好。监视元件任选可以用于评估在肾神经和/或平滑肌细胞中引起的例如电穿孔的程度，以及调节PEF参数至实现预期效果。
[0035]C.用于多脉管神经调制的系统和方法的实施方案
[0036]参考图4-7，描述多脉管PEF系统和方法的实例。图4显示多脉管脉冲电场装置100的实施方案，其包括配置成将脉冲电场递送到肾神经纤维以实现肾神经调制的多个电极110。电极110血管内地定位在多个脉管之内，所述脉管从主肾动脉RA分支。装置100还可以包括导管102，经由所述导管102可以将电极110递送到脉管分支。所述导管还可以包括定位元件104，如在下文中所描述。例如，在2005年5月13日提交的共同未决美国专利申请序号11/129,765中，申请人已经在前描述了血管内的PEF系统，已经将其通过参考全部结合于此。
[0037]装置100的近端部分一般具有一个或多个电连接器以将电极110耦合到脉冲发生器101。所述脉冲发生器位于所述患者以外。发生器以及这里所描述的电极实施方案的任一项可以供描述在下文中的本发明任何实施方案所用，用于递送具有所需场参数的PEF。应该理解，在下文中描述的实施方案的电极可以电耦合到所述发生器，即使所述发生器没有在每个实施方案中明确显示或描述。
[0038]如图4中所示，电极110定位在多个脉管中，所述脉管在肾K附近从肾动脉RA分支。所述电信号可以独立和/或动态地施加到每一个电极110以促进任一个电极和/或外部接地垫(未显示)之间/之中的单极和/或双极能量递送。例如，当一个或多个电极递送单极能量时，接地垫可以外部附着到患者的皮肤(例如，连接到患者的腿、侧腹、背部或侧面)。另外地或备选地，任选的接地垫可以邻近于目标肾而外部附着到患者以在单极电场中诱导所需的方向性。对于一些患者或对于一些适应证，双极和单极PEF治疗的组合可以比独立的双极和/或独立的单极治疗更有效。
[0039]预期在定位在不同脉管中的所需电极对110之间施加双极场，例如，在电极110a和电极110b之间，可以以将患者肾至少部分去神经的方式调制目标神经纤维的功能。电极110a和110b(以及电极110b和110c)任选可以沿着肾动脉RA的纵向尺寸相互侧面间隔，预期优先将电极之间递送的电场与目标神经纤维对准。神经调制可以以热或基本上无热的方式实现。这样的PEF治疗可以缓和CHF、高血压、肾病、心肌梗死、造影剂肾病和/或其它的肾或心-肾病的临床症状达数月的时期(例如，可能高达六个月或更多)。该时期可以足以容许身体痊愈以潜在地降低在急性心肌梗死以后CHF发作的风险并且减轻对随后的再治疗的需要。备选地，当症状复发时，或在规则预定间隔，患者可以返回医师以重复治疗。
[0040]初始治疗的效力，和由此的重复所述治疗的潜在需要可以通过监视数个不同的生理参数而评价。例如，血浆肾素水平，肾儿茶酚胺(例如，去甲肾上腺素)溢出，尿儿茶酚胺，或指示增加的交感神经活性的其它神经激素可以提供去神经程度的指标。另外地或备选地，核成像检测，例如利用131-碘间碘苄基胍(“MIBG”)，可以用于测量肾上腺素能神经支配的程度。作为另一个选择，可以用锝-99m巯基乙酰基甘氨酸(“Tc-99m MAG3”)进行成像以评价肾功能。备选地，可以进行已知的用于增加交感神经活性的刺激策略，例如头部在外的水浸没试验，以确定对重复治疗的需要。
[0041]PEF系统100的实施方案任选地可以包括一个或多个定位元件，用于将系统或部分系统定于患者的脉管系统中心或以其它方式定位在患者的脉管系统之内。例如，定位元件可以包括可臌胀的气囊和/或可扩展的金属线篮或笼。定位元件任选可以包括配置成在患者的脉管系统之内改变阻抗的阻抗改变元件，以更好地将施加的电场跨越血管壁定向到目标神经纤维。当所述定位元件是气囊时，它可以暂时阻塞血流并因此改变患者脉管内的阻抗。另外地或备选地，所述定位元件还可以包括一个或多个电极。在一个实施方案中，气囊定位元件具有导电的外部和/或是从导电聚合物制造的，其可以用作多脉管PEF系统中的电极。
[0042]在图4中，所述PEF系统100包括可扩展的定位元件104，其耦合到所述导管102。将定位元件104配置成用于以缩小模式递送构型递送至治疗位点和从治疗位点取回，并且在治疗位点膨胀成图4的展开构型。随着定位元件充分扩展，图4的展开构型，肾动脉RA内的阻抗特征可以被改变，和/或可以促进电极110向多个脉管分支的递送和从中取回。
[0043]如前所述，预期多脉管PEF治疗可以实现下列的一种或多种：不可逆电穿孔或电融合；坏死和/或细胞凋亡的诱导；基因表达的改变；动作电位阻断或衰减；细胞因子上调的改变；和目标神经纤维中的其它条件。在一些患者中，当这样的神经调制方法和装置应用于肾神经和/或促进肾神经功能的其它神经纤维时，申请人相信所述神经调制可以将患者的肾至少部分去神经。这可以导致增加的尿输出，降低的血浆肾素水平，降低的组织(例如，肾)和/或尿儿茶酚胺，肾儿茶酚胺(例如，去甲肾上腺素)溢出，增加泌尿系统的钠分泌，和/或控制的血压。而且，申请人相信这些或其它的改变可以预防或治疗充血性心力衰竭、高血压、心肌梗死、肾病、造影剂肾病、其它的肾系统疾病，和/或其它的肾或心-肾异常达数月的时期(例如，潜在地高达六个月或更多)。
[0044]这里所描述的方法和装置可用于调制传出的或传入的神经信号，以及传出的和传入的神经信号的组合。在不完全物理切断，即，不完全切割目标神经纤维的情况下，可以实现依照本发明的数个实施方案的神经调制。然而，应该理解，这样的神经调制可以在功能上实现类似于物理切断神经纤维的结果，即使所述纤维可以不必完全物理切断。
[0045]这里所描述的装置另外可以用于量化PEF治疗的功效、程度或细胞选择性以监视和/或控制所述治疗。当脉冲电场引发电穿孔时，电穿孔的组织的阻抗开始减小并且所述组织的电导率开始增加。如果电穿孔是可逆性的，则在终止PEF以后所述组织的电参数将返回到基线值或接近基线值。然而，如果电穿孔是不可逆的，则在终止PEF以后所述组织的电参数的改变将继续存在。这些现象可以用于监视PEF治疗的开始和效果。例如，可以利用电导率测量或阻抗测量直接监视电穿孔，例如电阻抗层析成象(“EIT”)、电阻抗或电导率指标和/或其它的电阻抗/电导率测量。这样的电穿孔监视数据任选可以用在一个或多个反馈回路中以控制PEF治疗的递送。
[0046]为了收集所需的监视数据，任选地，可以接近于所监视的组织提供另外的监视电极。优选地，将这样的监视电极之间的距离在治疗递送之前指定并且用于确定来自阻抗或电导测量的电导率。为了本发明的目的，阻抗的虚部可以忽略，因此将阻抗规定为峰值电压除以峰值电流，而电导可以限定为阻抗的倒数(即，峰值电流除以峰值电压)，并且电导率可以限定为单位距离的电导。例如，在2005年9月23日提出的共同未决的美国专利申请序号11/233,814中，申请人已经在前描述了用于监视PEF治疗的方法和装置并且已经提供了说明性的PEF波形，将其通过参考全部结合于此。
[0047]现在参考图5A和5B，描述了另外的用于肾神经调制的多脉管方法并且装置的实施方案。图5A的PEF系统200包括引导导管210，通过所述引导导管可以推进具有第一电极222和任选的定位元件224的第一元件220以及具有第二电极232的第二元件230。第一电极222定位在从肾动脉RA分支的第一脉管中，并且第二电极232定位在第二脉管或脉管的分支之内。定位元件224在第一脉管分支之内膨胀以将第一电极222居中于脉管内或以其它方式定位在脉管内和/或在所述脉管之内改变阻抗。例如，第一电极222可以是有源电极并且第二电极232可以是返回电极，用于在所述电极之间产生双极电场以调节促进肾功能的目标神经纤维。图5B图解另一个实施方案，其中第一元件220包括具有包含侧孔226的腔的导管。如所示，第二元件230可以定位在腔中并且可以经过第一元件220的侧孔226而将第二电极232定位在肾动脉RA的脉管分支之内。对于图5B中所示的实施方案，虽然单独的引导导管不是必然需要的，但是图5B中的第一元件220任选地可以通过单独的引导导管、例如图5A的引导导管210推进到位。
[0048]现在参考图6，描述了使用图5A的装置用于肾神经调制的另一种多脉管方法。除了在多个肾动脉RA的分支内定位电极以外，多脉管肾神经调制还可以用定位在另外的或替代的脉管之内的电极实现。在图6中，已经将第一元件220通过引导导管210推进到肾动脉RA之内的位置。第二元件230已经推进到腹主动脉AA之内的位置。双极电场可以在第一电极222和第二电极232之间递送以实现肾神经调制。
[0049]现在参考图7A和7B，除将电极放置在(a)肾动脉RA，(b)肾动脉的分支和/或(c)患者动脉脉管系统的另外的或备选的部分内以外，可以通过将一个或多个电极至少部分地定位在患者的静脉脉管系统内而实现多脉管肾神经调制。在图7中，电极定位在患者的肾动脉RA和肾静脉RV内。PEF系统300可以包括定位在肾动脉RA内的导管310和定位在肾静脉RV内的元件320。导管310包括第一电极312和任选的定位元件314。导管310可以推进到肾动脉内的位置中，例如，经过导线G，然后定位元件可以扩展到中心或另外将电极312定位在脉管内和/或改变脉管内的阻抗。元件320包括可以定位在肾静脉内的第二电极330，并且元件320可以任选包括定位元件。
[0050]双极电场可以在定位在肾动脉内的第一电极312和定位在肾静脉内的第二电极330之间递送，以通过多脉管方法调制促进肾功能的目标神经纤维。在图7A中，将电极312和330彼此相对侧面对准。在图7B中，将电极相互远离侧面隔开，其可以促进优先将跨越电极递送的双极电场与目标神经纤维对准。
[0051]如前所述，肾儿茶酚胺(例如，去甲肾上腺素)溢出可以表明通过依照本发明的方法实现的去神经或其它肾神经调制的程度。将肾儿茶酚胺溢出定义为：在通过肾动脉进入肾的肾儿茶酚胺的量和通过肾静脉离开肾的肾儿茶酚胺的量之间的不平衡。例如，神经调制可以诱导肾分泌比已经通过肾动脉进入肾的去甲肾上腺素更多的去甲肾上腺素进入肾静脉。肾儿茶酚胺溢出的基线测量可以在肾神经调制之前进行。然后可以将该基线与在肾神经调制以后获得的肾儿茶酚胺溢出的测量相比，并且该差异可以归结于肾神经调制。
[0052]为了测量肾儿茶酚胺溢出，可以从患者抽取血液。例如，可以从肾动脉和从肾静脉抽取血液，并且在动脉和静脉血液之间监视的肾儿茶酚胺的单位体积的差别可以用于量化肾儿茶酚胺溢出，并且由此估计肾神经调制的程度。例如，可以通过经由一个或多个用于将PEF系统递送到肾动脉和肾静脉的引导导管实现这样的血液抽取，所述PEF系统例如图7的PEF系统300。
[0053]另外地或备选地，可以通过整合到PEF系统中的一个或血液端口进行所述血液抽取。在图8的实施方案中，图7的PEF系统300的导管310包括用于抽取动脉血液的动脉血液端口316，并且元件320包括具有静脉血液端口322的导管，所述静脉血液端口322用于抽取静脉血液。另外的和备选的用于监视肾儿茶酚胺溢出的方法和装置对于本领域技术人员将是显而易见的。
[0054]除了在定位在第一脉管或脉管分支内的第一电极和定位在第二脉管或脉管分支之内的第二电极之间递送双极电场以外，可以在单独定位在单个脉管或脉管分支之内的第一和第二电极之间递送双极电场。如图9所示，第一双极电场可以在定位在第一脉管例如肾动脉RA之内的电极312a和312b之间递送，而第二双极电场可以在定位在第二脉管例如肾静脉RV之内的电极330a和330b之间递送。可以以在双极场之间产生重叠区域Z的方式递送第一和第二双极电场。
[0055]与定位在重叠区域Z之外的组织内的强度相比，定位在重叠区域Z之内的组织可以在组织之内显示局部增强强度的感应电场。当目标神经纤维例如目标肾神经纤维RN经过重叠区域Z时，目标神经纤维之内的局部增强强度的感应电场可以是足以理想地调制神经纤维的大小。而且，理想地，在重叠区域之外的感应电场的强度可以是不足以引起对于非目标组织损害的大小。因而，重叠电场可以降低不合需要的对于非目标组织的损害的风险，同时局部提供足够大小的感应电场以实现所需的肾神经调制。
[0056]导电组织的消融是另一种普遍使用的控制心脏动脉或室性心动过速的技术。消融可以如下进行：将导管引入到静脉系统中紧密接近肾脏交感神经，随后消融所述组织。通过用RF能量加热神经组织，基于导管的消融装置在以前用于终止神经的电刺激，所述RF能量可以通过电极系统递送。由此递送的RF能量终止神经传导。美国专利号6,292,695详细地描述了用神经刺激和消融用于跨脉管治疗心动过速和肌纤维震颤的方法和装置。类似的基于导管的装置可用于消融肾神经，目的在于治疗CRF。本发明中描述的方法适用于通过电能、冷却、或化学试剂例如酚或醇的不可逆的肾神经消融。
[0057]热方法可以用于冷却肾神经和相邻的组织以减少肾的交感神经刺激。具体而言，可以通过直接冷却肾神经或肾或通过冷却周围的组织而衰减肾神经信号，以降低它们的敏感性，代谢活性和功能。该方法的实例是使用Peltier装置的冷却效果。具体而言，传热接头可以临近脉管壁或肾动脉定位以提供冷却效果。冷却效果可以用于衰减由肾产生的信号。该方法的另一个实例是使用流体递送装置以递送凉的或冷的流体(例如盐水)。
[0058]在相对于目标神经元的所需位置将导管定位在脉管内以后，它可以稳定在所述脉管内(例如，靠着血管壁支撑)并且将能量递送到目标神经或神经元。在一个变体中，将RF能量递送到所述目标以发生非热的神经阻断，减少神经信号发生，或以其它方式调制神经活性。备选地或另外地，冷却，冷冻，热RF，热或非热的微波，聚焦的或非聚焦的超声，热或非热的DC，以及它们的任何组合，可以应用于减少或以其它方式控制神经发信号。
[0059]其它的脉冲电场系统的实施方案包括不物理接触血管壁的电极。RF能量、传统的热能和相对非热的脉冲RF，是可以从远离组织本身的短距离传导到要治疗的组织中的电场的实例。其它类型的电场还可以用于其中电极不物理接触所述血管壁的情形。因而，可以将电场通过电极接头和血管壁或其它组织之间的物理接触直接施加到神经，或在电极接头不物理接触血管壁的情况下所述电场可以间接施加到神经。因此，术语“神经接触”包括系统元件与神经和/或接近神经的组织的物理接触，以及在没有物理接触所述神经或组织情况下的单独电接触。为了间接施加所述电场，所述装置具有配置成将电极定位在脉管的中心区域或以其它方式将电极与血管壁隔开的定中心元件。所述定中心元件可以包括，例如，气囊或可膨胀的篮。一个或多个电极可以定位在定中心元件的中心轴上—或者与所述元件纵向对准或者定位在所述元件的两边。当利用气囊导管时，膨胀气囊可以作为具有增加的阻抗的绝缘体用于将脉冲电场沿着所需的电流途径取向或定向。显而易见的是，可以使用备选的绝缘体。
[0060]可以将热电偶整合到每个电极中或接近每个电极提供热电偶，并且可以接近一个或多个热电偶灌注冷却的(即，低于体温)流体或盐水。在热电偶之间探测的温度降低的时间延迟可以用于量化流动特性。可以在刺激肾神经之前确定所考虑的流动特性的基线估计值，并且可以将其与刺激以后确定的第二特性估计值相比较。
[0061]虽然在上面描述了本发明的优选的举例说明性的变体，但是对本领域技术人员显而易见的是，在不背离本发明的情况下可以对其进行多种改变和修改。例如，一个或多个电极可以定位在患者静脉脉管系统的其它部分中，例如在患者的下腔静脉之内或在患者的肾静脉的脉管分支之内。在后附的权利要求中意欲包括属于本发明的真实实质和范围内的全部这样的改变和修改。

Claims (33)

1.一种用于患者的多脉管肾神经调制的方法，所述方法包括：
接近促进患者的肾功能的神经纤维，将第一电极放在所述患者的第一脉管中；
将第二电极放在所述患者的第二脉管中，其中所述第二脉管是不同于所述第一脉管的脉管；和
使电流通过所述第一电极和所述第二电极，以调制所述神经纤维的功能。
2.权利要求1的方法，其中使电流通过所述第一和第二电极包括：在所述第一和第二电极之间产生电场。
3.权利要求1的方法，其中使电流通过所述第一和第二电极包括：在所述第一电极和远处电极之间产生第一电场，和在所述第二电极和所述远处电极之间产生第二电场。
4.权利要求3的方法，其中所述第一和第二电场是同时产生的。
5.权利要求3的方法，其中所述第一和第二电场是顺序产生的。
6.权利要求1的方法，其中使电流通过所述第一和第二电极包括：在所述第一脉管中在所述第一电极和第一远处电极之间产生第一电场，和在所述第二脉管中在所述第二电极和第二远处电极之间产生第二电场。
7.权利要求6的方法，其中所述第一和第二电场是同时产生的。
8.权利要求6的方法，其中所述第一和第二电场是顺序产生的。
9.权利要求1的方法，其中通过电流还包括通过脉冲电流。
10.权利要求1的方法，其中调制所述神经纤维的功能还包括：将所述肾至少部分地去神经。
11.权利要求1的方法，其中调制所述神经纤维的功能还包括：在所述神经纤维中诱导选自由下列组成的组的一种作用：不可逆的电穿孔，电融合，坏死，细胞凋亡，基因表达改变，细胞因子上调改变，和它们的组合。
12.权利要求1的方法，其中调制所述神经纤维的功能还包括：热调制所述神经纤维的功能。
13.权利要求1的方法，其中调制所述神经纤维的功能还包括：平均在所述电流通过期间，基本上无热地调制所述神经纤维的功能。
14.权利要求1的方法，其中调制所述神经纤维的功能还包括：治疗使所述患者痛苦的医学病症。
15.权利要求14的方法，其中治疗使所述患者痛苦的医学病症还包括：治疗选自由下列组成的组的一种医学病症：心力衰竭，高血压，心肌梗死，肾病，造影剂肾病，和它们的组合。.
16.权利要求1的方法，其中将所述第一电极放在所述第一脉管中还包括：将所述第一电极放在所述患者的肾脉管系统的第一脉管中。
17.权利要求16的方法，其中将所述第二电极放在所述第二脉管中还包括：将所述第二电极放在所述患者的所述肾脉管系统的第二脉管中，所述第二脉管是不同于所述第一脉管的所述肾脉管系统的脉管。
18.权利要求17的方法，其中将所述第二电极放在所述患者的所述肾脉管系统的所述第二脉管中还包括：将所述第二电极放在所述肾脉管系统的第二脉管分支中。
19.权利要求1的方法，其中将所述第一电极放在所述第一脉管中和将所述第二电极放在所述第二脉管中还包括：将所述第一电极和所述第二电极放在所述患者的不同脉管中，所述脉管选自由下列组成的组：肾动脉，肾动脉分支，肾静脉，肾静脉分支，下腔静脉，腹主动脉，肾脉管系统，静脉脉管系统，动脉脉管系统，和它们的组合。
20.权利要求1的方法，所述方法还包括：在所述电流通过以前，在所述第一脉管或所述第二脉管中改变阻抗。
21.权利要求20的方法，其中改变阻抗还包括：暂时改变所述第一脉管或所述第二脉管之内的血流量。
22.权利要求1的方法，其中通过所述电流还包括：优先地使所述电流与所述神经纤维的纵向尺寸对准。
23.权利要求22的方法，其中对准所述电流还包括：放置所述第一电极和放置所述第二电极，以使所述第一电极和所述第二电极相互间隔开大约所述神经纤维的纵向尺寸。
24.权利要求1的方法，所述方法还包括：监视响应于所述电流通过的肾儿茶酚胺溢出的改变。
25.一种用于患者的肾神经调制的方法，所述方法包括：
将第一电极放在患者的第一脉管之内，至少基本上接近于促进所述患者的肾功能的神经纤维；
将第二电极放在所述患者的第二脉管之内，其中所述第二脉管是不同于所述第一脉管的脉管；和
在所述第一电极和所述第二电极之间传送电场，以使得到的电场一般地与肾动脉的纵轴对准，由此调制所述神经纤维的功能，所述肾动脉与肾相关联。
26.权利要求25的方法，其中将所述第一电极放在所述第一脉管内和将所述第二电极放在所述第二脉管内还包括：将所述第一电极和所述第二电极放在所述患者的不同脉管中，所述脉管选自由下列组成的组：肾动脉，肾动脉分支，肾静脉，肾静脉分支，下腔静脉，腹主动脉，肾脉管系统，静脉脉管系统，动脉脉管系统，和它们的组合。
27.权利要求25的方法，所述方法还包括：监视响应于所述电场的传送的肾儿茶酚胺溢出的改变。
28.用于实施患者的肾神经调制的装置，所述装置包括：
电场发生器；
用于放置在所述患者的第一脉管之内而配置的第一元件，所述第一元件包括电耦合至所述电场发生器的第一电极；和
用于放置在所述患者的不同于所述第一脉管的第二脉管之内而配置的第二元件，所述第二元件包括电耦合至所述电场发生器的第二电极，
其中配置所述装置以在所述第一电极和所述第二电极之间传送电场以调制促进肾功能的神经纤维，同时将所述第一装置定位在所述第一脉管之内并且将所述第二装置定位在所述第二脉管之内。
29.权利要求28的装置，其中所述第一元件或所述第二元件包括定位元件。
30.权利要求29的装置，其中所述定位元件配置成在所述患者的脉管之内改变阻抗。
31.权利要求28的装置，其中配置所述装置以在所述第一电极或所述第二电极和定位在所述患者以外的接地垫之间单极传送所述电场。
32.权利要求28的装置，所述装置还包括一种元件，所述元件用于监视响应于所述电场的传送的肾儿茶酚胺溢出的改变。
33.权利要求28的装置，其中所述电场是脉冲电场。
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US20180021574A1 (en) 2018-01-25
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US9950161B2 (en) 2018-04-24
US9108040B2 (en) 2015-08-18
US20150025603A1 (en) 2015-01-22
US9402992B2 (en) 2016-08-02
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US20060235474A1 (en) 2006-10-19
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US20170021170A1 (en) 2017-01-26
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