CN101443072A - 双侧肾神经调制的方法和装置 - Google Patents

双侧肾神经调制的方法和装置 Download PDF

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CN101443072A
CN101443072A CNA2007800150219A CN200780015021A CN101443072A CN 101443072 A CN101443072 A CN 101443072A CN A2007800150219 A CNA2007800150219 A CN A2007800150219A CN 200780015021 A CN200780015021 A CN 200780015021A CN 101443072 A CN101443072 A CN 101443072A
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CN101443072B (zh
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丹尼丝·德马瑞斯
汉森·Ⅲ·吉福德
马克·迪姆
道格拉斯·萨顿
霍华德·R·莱文
马克·盖尔芬德
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Medtronic Adian LLC
Medtronic Ardian Luxembourg SARL
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Abstract

本发明提供了用于双侧肾神经调制的方法和装置，例如，通过脉冲电场，通过刺激电场，通过局部化的药物递送，通过高频超声波，通过热技术等。这样的神经调制可以完成不可逆的电穿孔或电融合，坏死和/或程序性细胞死亡的诱导，基因表达的改变，动作电位衰减或阻滞，细胞因子上调的改变和靶点神经纤维中其它条件的改变。在一些实施方案中，神经调制应用到对肾功能有贡献的神经纤维上。在一些实施方案中，这样的神经调制以双侧方式进行。当与单侧进行的肾神经调制相比时，即，当与在神经支配单肾的神经组织上进行的肾神经调制相比时，双侧肾神经调制可以在一些患者中提供提高的治疗作用。

Description

双侧肾神经调制的方法和装置
相关申请的交叉参考
本申请是下列同时待审的美国专利申请的每一申请的部分继续：
(1)美国专利申请号10/408,665，其于2003年4月8日提交(于2003年11月20日作为美国专利公布2003/0216792公布)，其要求于2003年1月29日提交的美国临时专利申请号60/442,970；于2002年10月3日提交的60/415,575；和于2002年4月8日提交的60/370,190的利益。
(2)美国专利申请号11/133,925，其于2005年5月20日提交，其是于2004年7月28日提交的美国专利申请号10/900,199(现在是美国专利号6,978,174)的继续，美国专利申请号10/900,199是于2003年4月8日提交的美国专利申请号10/408,665的部分继续。
(3)美国专利申请号11/189,563，其于2005年7月25日提交，其是于2005年5月13日提交的美国专利申请号11/129,765的部分继续，美国专利申请号11/129,765要求于2004年10月5日提交的美国临时专利申请号60/616,254；和于2004年11月2日提交的60/624,793的利益。
(4)美国专利申请号11/266,933，其于2005年11月4日提交。
(5)美国专利申请号11/363,867，其于2006年2月27日提交，题目为通过血管内-到-外途径的脉冲电场神经调制的方法和装置(Methods andApparatus for Pulsed Electric Field Neuromodulation Via an Intra-To-Extravascular Approach)(律师记录号57856.8010US1)，其(a)要求于2005年12月29日提交的题目为通过血管内-到-外途径的脉冲电场神经调制的方法和装置(Methods and Apparatus for Pulsed Electric Field NeuromodulationVia an Intra-To-Extra vascular Approach)的美国临时申请号60/813,589(律师记录号57856.8010US，并且最初以美国申请号11/324,188提交)的利益，并且(b)是于2005年7月25日提交的美国专利申请号11/189,563，和于2005年11月4日提交的美国专利申请号11/266,933的每一申请的部分继续。
所有前述申请、公布和专利都通过引用完全结合于本申请。
通过引用结合
所有在本说明书中提及的公布和专利申请都如同单个公布或专利申请专门地或单独地指示通过引用结合一样通过引用同等程度地结合于此。
技术领域
本发明涉及神经调制的方法和装置。在一些实施方案中，本发明涉及实现双肾神经调制的方法和装置。
背景技术
充血性心力衰竭(“CHF”)是在心脏受到损伤并且减少流到机体器官中的血流时发生的病况。如果血流充分减少，那么肾功能将改变，这导致流体滞留，异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，并且进一步减少心脏泵血通过肾脏和循环系统的能力。
据信，肾脏的逐渐减少的灌注是使得CHF下行盘旋永续的主要非心脏因素。此外，流体负担和由这些生理变化导致的相关临床症状导致额外的的医院许可、很坏的生活质量和卫生保健系统的额外成本。
除了它们在CHF进展中的作用之外，肾脏在慢性肾衰竭(“CRF”)、晚期肾病(“ESRD”)、高血压(病理性高血压)和其它心-肾疾病的发展中起重要作用。肾脏的功能可以在3个主要方面进行总结：过滤血液和排泄由机体代谢产生的废物；调节盐、水、电解质和酸-碱平衡；并且分泌激素以维持重要器官的血流。在没有正确功能的肾脏情况下，患者将患有水分滞留、减少的尿流和废物毒素在血液和机体中的累积。这些病症由减少的肾功能或肾衰竭(renal failure)导致，并且据信这些病症增加心脏工作负担。在CHF患者中，当由于弱功能性肾脏引起流体滞留和血液毒素积累时，肾衰竭将使得心脏进一步恶化。
已经在动物模型中确定，心脏衰竭病况导致肾脏的异常高的交感神经激活。肾脏交感神经活性的增加导致水分和钠从机体的去除减少，以及增加的肾素分泌。增加的肾素分泌导致供应肾脏的血管的血管收缩，这引起减少的肾血流。交感肾神经活性的减小，例如，通过去神经作用，可能逆转这些过程。
申请人先前已经描述了通过对肾功能有贡献的神经纤维施加脉冲电场而治疗肾紊乱的方法和装置。参见，例如，申请人于2005年5月13日提交的同时待审的美国专利申请系列号11/129,765，和于2005年7月25日提交的系列号11/189,563，二者都通过引用完全结合于此。脉冲电场(“PEF”)可以发动肾神经调制，例如，去神经作用，例如，通过不可逆的电穿孔或通过电融合进行。PEF可以由放置在血管内、血管外、血管内-到-外或它们的组合的装置中输送。描述了用于实现肾神经调制的其它的方法和装置，例如，通过局部化的药物递送(诸如通过药物泵或输注导管)或通过使用刺激电场等，例如，在于2003年4月8日共同所有的和同时待审的美国专利申请系列号10/408,665中，和美国专利号6,978,174中描述，二者通过引用完全结合于此。
当用于本文时，电融合包括通过暴露于电场诱导的相邻细胞的融合。用于电融合目的的靶点相邻细胞之间的接触可以以各种方式实现，包括，例如，通过介电电泳。在组织中，所述靶点细胞可以是已经接触的，由此促进电融合。
当用于本文时，电穿孔和电渗透是操作细胞膜或细胞内装置的方法。例如，细胞膜的多孔性可以通过，例如，短的、高压脉冲跨越细胞膜诱导足够的电压而增加。细胞膜中多孔性的程度(例如，孔的尺寸和数量)和作用的持续时间(例如，暂时的或持久的)是多种变量的函数，诸如场强、脉冲宽度、工作周期(duty cycle)、电场方向、细胞类型或尺寸、和/或其它参数。
当相对低强度的电场或相对短的脉冲宽度的终止时，细胞膜孔通常是自发关闭的(本文定义为“可逆的电穿孔”)。然而，每种细胞或细胞类型具有临界阈值，高于该临界阈值孔不会关闭，以致孔的形成不再是可逆的；这一结果定义为“不可逆的电穿孔”，“不可逆的击穿”或“不可逆的损伤”。在这一点上，细胞膜破裂，和/或发生由高多孔性引起的不可逆的化学不平衡。这样高的多孔性可能是单个大孔和/或多个更小的孔的结果。
使用血管内PEF系统治疗肾病症的潜在的挑战是选择性电穿孔靶点细胞而不影响其它细胞。例如，可以理想地不可逆地电穿孔沿着或接近肾血管的肾神经细胞，但是可能不理想地损伤组成血管的平滑肌细胞。结果，过于激进的PEF治疗疗程可能持久地损伤肾血管，但是过于保守的PEF治疗疗程可能不会获得需要的肾神经调制。
申请人先前描述了用于下列的方法和装置：监测组织阻抗或传导率以确定脉冲电场治疗的作用，例如，确定电穿孔的程度和/或其不可逆性的程度。参见，例如，申请人于2005年9月23日提交的同时待审的美国专利申请系列号11/233,814，其通过引用完全结合于此。组织的脉冲电场电穿孔引起组织阻抗的减少和组织传导率的增加。如果诱导的电穿孔是可逆的，那么在停止所述脉冲电场时，组织阻抗和传导率应该接近基线水平。然而，如果电穿孔是不可逆的，在终止脉冲电场后，阻抗和传导率变化应该持续。因此，监测靶点和/或非靶点组织的阻抗和传导率可以用来确定电穿孔的发作和确定电穿孔的类型或程度。此外，监测数据可以用于一个或多个手工的或自动的反馈环来控制电穿孔。
本发明将理想地提供实现双肾神经调制的方法和装置。
概述
本发明提供神经调制的方法和装置，例如，通过脉冲电场(“PEF”)，通过刺激电场，通过局部化药物递送，通过高频超声波，通过热技术，它们的组合等。这样的神经调制可以，例如，实现不可逆的电穿孔或电融合，坏死和/或程序性细胞死亡的诱导，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以及靶点神经纤维中其它条件的改变。在一些患者中，当将本发明的神经调制方法和装置用于肾神经和/或其它对肾神经功能有贡献的神经纤维时，申请人相信由神经调制诱导的神经调制作用可能导致增加的尿输出，减少的血浆肾素水平，减少的组织(例如，肾)和/或尿儿茶酚胺(例如，去甲肾上腺素)，增加的尿钠排泄，和/或受到控制的血压。此外，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、急性心肌梗死、晚期肾病、造影剂肾病(contrast nephropathy)、其它肾脏系统疾病、和/或其它肾或心-肾异常。本文所述的方法和装置可以用来调制传出或传入神经信号，以及传出和传入神经信号的组合。
肾神经调制优选地以双侧的形式进行，以便调制对右肾和左肾的肾功能有贡献的神经纤维。当与单侧进行的肾神经调制相比时，即，当与在神经支配单一肾的神经组织上进行的肾神经调制相比时，双侧肾神经调制可以在一些患者中提供提高的治疗作用。在一些实施方案中，可以实现对右肾和左肾功能都有贡献的神经纤维的同时调制。在另外的或备选的实施方案中，这样的右和左神经纤维的调制可以是顺序的。当需要时，双侧肾神经调制可以是连续的或间歇的。
当使用电场时，当需要时，电场参数可以改变或以任何组合而组合。这样的参数可以包括，但不限于，电压、场强、脉冲宽度、脉冲持续时间、脉冲的形状、脉冲的数目和/或脉冲之间的时间间隔(例如，工作周期)等。例如，当使用脉冲电场时，适宜的场强可以高达约10,000V/cm，并且适宜的脉冲宽度可以高达约1秒。例如，适宜的脉冲波形形状包括AC波形、正弦曲线波、余弦波、正弦和余弦波的组合、DC波形、DC-偏移AC波形、RF波形、方波、梯形波、指数衰减波、或它们的组合等。场包括至少一个脉冲，并且在许多应用中，场包括多个脉冲。例如，适宜的脉冲时间间隔包括小于约10秒的间隔。这些参数作为适当的实例提供，决不应该认为是限制。
附图简述
在结合附图考虑下述详述时，本发明的一些实施方案将是显而易见的，在附图中相同的参照字母始终指相同的部分，并且，在附图中：
图1是说明人肾解剖的示意图。
图2是显示相对于肾动脉的肾神经的位置的示意性等比例详图。
图3A和3B是分别说明用于选择性影响肾神经的电场的取向的示意性等比例图和端视图。
图4是说明肾神经调制的血管外方法和装置的实施例的部分剖面地示意性侧视图。
图5A和5B是分别说明用于肾神经调制的血管内和血管内-到-外的方法和装置的部分剖面地示意性侧视图。
图6A-6H是说明使用本发明的装置，说明使用图5A的装置实现双侧肾神经调制的方法的部分剖面地示意性侧视图。
图7A和7B是说明使用图5A装置的实施方案实现同时的双侧肾神经调制的方法的部分剖面地示意性侧视图。
图8是说明使用图4装置的备选实施方案实现同时的双侧肾神经调制的方法的部分剖面地示意性侧视图。
图9是说明通过局部化药物递送实现双侧肾神经调制的方法和装置的实施例的示意图。
详述
A.概述
本发明涉及神经调制的方法和装置，例如，去神经作用。在一些实施方案中，本发明提供实现双侧肾神经调制的方法和装置。当与单侧进行的肾神经调制相比时，即，当与在神经支配单一肾的神经组织上进行的肾神经调制相比时，双侧肾神经调制可以在一些患者中提供提高的治疗作用。在一些实施方案中，可以实现对右肾和左肾功能两者都有贡献的神经纤维的同时调制。在另外的或备选的实施方案中，这样的右和左神经纤维的调制可以是顺序的。当需要时，双侧肾神经调制可以是连续的或间歇的。
本发明的方法和装置可以用来调制对肾功能有贡献的神经纤维，并且可以利用实现需要的神经调制的任何适当的神经调制技术。例如，可以使用任何适当的电信号或场参数，例如，实现需要的神经调制(例如，电穿孔作用)的任何电场。备选地或另外地，神经调制可以通过局部化递送神经调制剂或药物实现。为了更好地理解本发明的装置的结构和使用这样的装置进行双侧肾神经调制的方法，检验人体肾脏解剖是指导性的。
B.神经调制方法的选择实施方案
现在参考图1，人肾脏解剖包括通过肾动脉RA供应有氧血的肾脏K，肾动脉RA通过腹部主动脉AA连接到心脏。去氧血液通过肾静脉RV和下腔静脉IVC从肾脏流到心脏。图2更详细地图示肾脏解剖的部分。更具体地，肾脏解剖还包括沿着通常在动脉外膜内的肾动脉RA的纵向维度L而纵向延伸的肾神经RN。肾动脉RA具有平滑肌细胞SMC，其环绕动脉圆周并且围绕动脉的角轴θ盘旋。因此，肾动脉的平滑肌细胞具有横断肾动脉的纵向维度(即不平行)延伸的纵向或较长维度。肾神经和平滑肌细胞的纵向维度的不重合(misalignment)定义为“细胞不重合”。
参考图3A和3B，肾神经和平滑肌细胞的细胞不重合可以用来选择性地影响肾神经细胞，所述受影响的肾神经细胞对平滑肌细胞具有减小的作用。更具体地，由于更大的细胞需要更低的电场强度来超过细胞膜不可逆的阈值电压或用于不可逆电穿孔的能量，所以，本发明的电极的实施方案可以设置成将由所述电极产生的至少部分电场沿着或者靠近要影响的细胞的较长维度排列。在具体的实施方案中，所述装置具有这样的电极，即，所述电极被设置成产生沿着或者靠近肾动脉RA的纵向维度L排列的电场，以影响肾神经RN。通过排列电场，以便所述场优先沿着细胞的纵向方面，而不是细胞的直径或径向方面排列，可以使用更低的场强来影响靶点神经细胞，例如，使靶点细胞坏死或融合，以诱导程序性细胞死亡，以改变基因表达，以衰减或阻断动作电位，以改变细胞因子上调和/或以诱导其它适当的过程。预计这减少输送到系统的总能量，并且减轻对电场中非靶点细胞的作用。
类似地，关于神经细胞的较长维度，在靶点神经之上或之下的组织的纵向或较长的维度是垂直的或另外离轴的(off-axis)(例如，横截的)。因此，除了沿着靶点细胞的纵向或较长维度排列脉冲电场(“PEF”)之外，PEF可以沿着非靶点细胞的横向或较短维度传播(即，以致PEF至少部分沿着非靶点平滑肌细胞SMC排列之外传播)。因此，如在图3A和3B中所示，施加具有通常沿着肾动脉RA的纵向维度L排列的传播线Li的PEF，预计优先在靶点肾神经RN细胞中引起电穿孔(例如，不可逆的电穿孔)、电融合、或其它神经调制，而不会过度影响非靶点动脉平滑肌细胞SMC。脉冲电场可以以沿着肾动脉纵轴的单个平面传播，或者可以以沿着从0°-360°范围的任何角度的扇形(segment)θ的纵向方向传播。
位于肾动脉壁内和/或接近肾动脉壁的PEF系统可以传播具有纵向部分的电场，所述纵向部分沿着在肾神经RN和血管壁平滑肌细胞SMC区域的动脉的纵向维度排列，以致动脉壁保持至少基本上是完好的，而外部的神经细胞被破坏、融合或另外影响。监测元件可以用来评估在肾神经和/或在平滑肌细胞中诱导的例如电穿孔的程度，以及调整PEF参数以获得需要的作用。
C.神经调制的系统和另外方法的示例性实施方案
参考图4和5，描述了PEF系统和方法的实施例。图4显示一个血管外脉冲电场装置200的实施方案，该装置包括一个或多个设置成将脉冲电场输送到肾神经纤维以实现肾神经调制作用的电极。图4的装置被设置成临时的血管外放置；然而，应该理解，可以另外或备选地使用部分或完全可植入的血管外装置。申请人先前已经描述了血管外PEF系统，例如，在于2005年6月25日提交的同时待审的美国专利申请系列号11/189,563中，其通过引用完全结合于此。
在图4中，装置200包括具有探针210的腹腔镜或经皮PEF系统，例如在CT或射线成像的引导下，设置所述探针210插入在沿着肾动脉或静脉或肾门和/或Gerota筋膜内的肾神经供应的轨道的邻近处。设置至少一个电极212用于通过探针210输送到治疗位点，用以输送脉冲电场治疗。例如，电极212可以安装在导管上，并且通过电线211电耦合到脉冲发生器50。在一个备选的实施方案中，探针210的远端部分具有一个电极212，并且所述探针可以具有电连接器，以将所述探针耦合到脉冲发生器50，用于将PEF输送至一个或多个电极212。
脉冲电场发生器50位于患者的外部。发生器、以及本文描述的任何PEF-输送电极实施方案，可以与本发明的任何实施方案一起使用，用以输送具有需要的场参数的PEF。应该理解，即使每个实施方案没有清楚地显示或描述发生器，下文所述实施方案的PEF-输送电极可以电连接至发生器。
电极212可以是彼此电独立的单个电极，具有共同连接的触点的节段电极，或者连续电极。例如，节段电极可以通过提供配合到电极上的开槽导管而形成，或者通过电连接一系列的单个电极而形成。单个电极或电极212的组可以设置成提供双极信号。电极212可以动态指定成促进任何电极之间和/或任何电极与外部接地垫板(ground pad)之间的单极和/或双极能量输送。这样一种接地垫板可以，例如，在外部附着到患者皮肤上，例如，患者的腿或胁腹上。在图4中，电极212包括双极电极对。探针210和电极212可以与临床上用于脉冲的RF神经阻滞的标准针或套管针型相似。备选地，装置200可以包括柔软的和/或用户定制设计的探针，以用于本文所述的肾应用。
在图4中，经皮探针210已经通过经皮通路位点P推进到患者肾动脉RA的邻近处中。该探针穿过患者的Gerota筋膜F，并且电极212通过探针推进到位置并且沿着患者动脉和筋膜之间的环形空间。一旦准确地定位，脉冲电场治疗可以穿过双极电极212而应用到靶点神经纤维。这样的PEF治疗可以，例如，通过靶点神经纤维细胞的不可逆电穿孔至少部分将由该靶点神经纤维神经支配的肾脏去神经。电极212任选地还可以用来监测PEF治疗的电穿孔作用。治疗后，装置200可以从患者移除以终止程序。
现在参考图5A，描述了血管内PEF系统的实施方案。申请人先前已经描述了血管内PEF系统，例如，在于2005年5月13日提交的同时待审的美国专利申请系列号11/129,765中，其通过引用完全结合于此。图5A的实施方案包括装置300，该装置300包括具有定心元件304(例如，气球、可扩张的金属丝篮、其它机械扩张器，等)的导管302、沿着导管的轴放置的轴电极306a和306b、和任选地在所述定心元件304区域沿着导管轴放置的辐射透不过的标记308。电极306a-b，例如，可以这样排列，以致电极306a接近定心元件304的近端，并且电极306b接近定心元件304的远端。电极306电耦合到脉冲发生器50(参见图4)，所述脉冲发生器50放置在患者外部，用于输送PEF治疗。
定心元件304可以包括阻抗改变的元件，其在PEF治疗过程中改变电极306a和306b之间的阻抗，例如，以更好地引导PEF治疗穿过血管壁。这可以减小获得需要的肾神经调制的应用电压。申请人先前已经描述了阻抗改变元件的应用，例如，在于2005年11月4日提交的同时待审的美国专利申请系列号11/266,993中，其通过引用完全结合于此。当定心元件304包括可膨胀的气球时，该气球可以作为电极306的定心元件和作为阻抗改变的电绝缘体，以引导所输送的电场穿过电极，例如，以引导电场进入或穿过血管壁，从而调制靶点神经纤维。由元件304提供的电绝缘可以减少应用电压或在靶点纤维获得需要的场强所必需的脉冲电场的其它参数的大小。
电极306可以是单个电极(即，独立的触点)、具有共同连接的接触器的节段电极、或单一的连续电极。此外，电极306可以设置成提供双极信号，或电极306可以一起使用或单独地与单独的患者接地垫板联合一起用于单极应用。作为备选方案，或者除了将电极306沿着导管302的中轴放置以外，如在图5A中，电极306可以附着到定心元件304上，以便它们接触肾动脉RA的壁。在这样的改变中，电极可以，例如，固定在内表面上、外表面或至少部分包埋在所述定心元件的壁内。所述电极任选地可以用来检测PEF治疗的作用，如下文所述。由于可以理想地减少或最小化在输送PEF治疗过程中的PEF输送电极和血管壁之间的物理接触，例如，减少损伤壁的电势，电极306可以，例如，包括附着到导管轴上的第一套电极，用于输送PEF治疗，并且所述装置还可以包括第二套电极，其附着到定心元件304上，用于监测通过电极306输送的PEF治疗的作用。
在使用中，以低档输送构型，例如，通过引导导管，可以将导管302输送至肾动脉RA，如所示，或者可以将其输送至肾静脉，或输送至邻近对肾功能有贡献的肾组织的任何其它血管中。一旦放置在肾血管内部，任选的定心元件304可以扩张成与血管内壁接触。然后可以通过PEF发生器50产生脉冲电场，通过导管302转移到电极306，并且通过电极306穿过动脉壁输送。PEF治疗调制对肾功能有贡献的神经纤维的活性，例如，将由所述神经纤维神经支配的肾脏至少部分去神经。例如，这可以通过在神经细胞中不可逆的电穿孔、电融合和/或程序性细胞死亡的诱导作用而获得。在许多应用中，电极这样排列，以便脉冲电场沿着肾动脉的纵向维度排列，从而促进对肾神经的调制，而对非靶点平滑肌细胞或其它细胞几乎没有作用。
除了血管外和血管内PEF系统之外，可以提供血管内-到-外的PEF系统，其具有这样的电极，该电极被输送到血管内位置，然后在输送PEF治疗之前至少部分通过/穿过血管壁到血管外位置。与完全血管内放置电极相比较，血管内-到-外放置电极可以在PEF治疗过程中将电极放置在更接近靶点神经纤维处。申请人先前已经描述了血管内-到-外PEF系统，例如，在于2005年12月29日提交的同时待审的美国专利申请系列号11/324,188(以下“‘188申请”)中，其通过引用完全结合于此。
参考图5B，显示了先前在‘188申请中描述的血管内-到-外(“ITEV”)PEF系统的一个实施方案。ITEV PEF系统320包括导管322，其具有(a)在近侧端口324终止的多个近端电极腔(lumen)，(b)在远侧端口326终止的多个远端电极腔，和(c)导线腔323。导管322优选地包括等数目的近端和远端电极腔和侧端口。系统320还包括可以穿过近端电极腔推进的近端针电极328，和远侧端口324，以及可以穿过远端电极腔推进的远端针电极329，和远侧端口326。
导管322包括任选的可扩张的定心元件330，其可以包括膨胀的气球或可扩张的篮或笼。在使用时，定心元件330可以在展开针电极328和329之前扩张，以便将导管322放置在患者血管内(例如，在肾动脉RA内)的中央。将导管322放置在中央预计促进将所有针电极输送至患者血管内部/外部的需要的深度(例如，将所有针电极输送至大约相同的深度)。在图5B中，举例说明的定心元件330放置在近侧端口324和远侧端口326之间，即，在近端和远端电极的输送位置之间。然而，应该理解，另外或备选地，定心元件330可以放置在不同位置或沿着导管长度的多个位置(例如，在邻近侧端口324的位置和/或在远离侧端口326的位置)。
如在图5B中所举例说明，导管322可以通过腔323经由导线(未显示)推进到患者血管内的治疗位点(例如，患者肾动脉RA内的治疗位点)。在血管内输送过程中，电极328和329可以这样放置，以便它们非绝缘的和尖锐的远端区域分别放置在近端和远端腔内。一旦放置在治疗位点，医学执业者可以通过它们位于患者外部的近端区域推进电极。这样的推进引起电极328和329的远端区域分别离开侧端口324和326，并且穿透患者血管壁，以致电极通过ITEV途径在血管外放置。
近端电极328可以与PEF发生器50连接作为活性电极，并且远端电极329可以作为返回电极(return electrode)。以这种方式，近端和远端电极形成双极电极对，其将PEF治疗沿着患者血管的纵轴或纵向方向排列。显而易见地，远端电极329备选地可以包括活性电极，并且近端电极328可以包括返回电极。此外，近端和/或远端电极可以包括活性电极和返回电极二者。当需要时，可以使用活性电极和远端电极的任何组合。
当电极328和329与PEF发生器50连接并且血管外放置时，并且在定心元件330任选地扩张的情况下，PEF治疗可以继续进行获得需要的神经调制。在完成PEF治疗后，电极可以缩回到近端和远端腔内，并且定心元件330可以折叠以取回。然后，ITEV PEF系统320可以从患者移出以结束程序。另外地或者备选地，所述系统可以重新放置，以在另一个治疗位点提供PEF治疗，例如，提供双侧肾神经调制。
预计本发明用于神经调制的PEF治疗，以及其它方法和装置(例如，刺激电场、局部化药物递送、高频超声波、热技术等)，不管血管外、血管内、血管内-到-外递送或它们的组合，例如，可以实现不可逆的电穿孔或电融合、坏死和/或诱导程序性细胞死亡、改变基因表达、动作电位阻滞或衰减、细胞因子上调和靶点神经纤维中其它条件的改变。在一些患者中，当将这样的神经调制方法和装置用于肾神经和/或对肾神经功能有贡献的其它神经纤维时，申请人相信由所述神经调制诱导的神经调制作用可能导致增加的尿输出、减少的血浆肾素水平、减少的组织(例如，肾)和/或尿儿茶酚胺(例如，去甲肾上腺素)、增加的尿钠排泄、和/或得到控制的血压。此外，申请人相信这些或其它改变可以在数月的期间，有力地多达6个月或以上，预防或治疗充血性心脏衰竭、高血压、急性心肌梗死、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。该时间期间可以足以允许机体痊愈；例如，该期间可以减少在急性心肌梗死后CHF发作的危险，由此减少对随后的再治疗的需要。备选地，当症状再发生时，或以有规则预定的时间间隔，患者可以回到医师那里进行重复治疗。本文所述的方法和装置可以用来调制传出或传入神经信号，以及传出和传入神经信号的组合。优选地实现按照本发明的神经调制，而没有完全物理切断，即，没有完全切断靶点神经纤维。然而，应该理解，这样的神经调制可以功能性切断神经纤维，即使所述纤维可以不是完全物理切断的。本文示例性所述的装置和方法设置成经皮使用。这样的经皮使用可以是腔内的、腹腔镜的、它们的组合等。
参考图4和5的上述装置另外可以用于定量PEF治疗的功效、程度或细胞选择性，以监测和/或控制该治疗。当脉冲电场开始电穿孔时，被电穿孔组织的阻抗开始减小，并且该组织的传导率开始增加。如果电穿孔是可逆的，那么在终止PEF时，组织电参数将恢复或近似于基线值。然而，如果电穿孔是不可逆的，那么在终止PEF后，组织参数的变化将持续。这些现象可以用来监测PEF治疗的开始和效果。例如，可以使用，例如，传导率测量或阻抗测量，诸如电阻抗X线断层摄影(“EIT”)和/或其它电阻抗/传导率测量，如电阻抗或传导率指数，直接监测电穿孔。这样的电穿孔检测数据任选地可以用在一个或多个反馈环中，以控制PEF治疗的输送。
为了收集需要的监测数据，另外的监测电极任选地可以邻近被监测组织提供。在这样的监测电极之间的距离优选地将在治疗输送之前确定，并且用来从阻抗或电导测量确定传导率。对于本发明的目的，阻抗的虚部可以被忽略，以便阻抗可以定义为电压除以电流，而电导可以定义为阻抗的倒数(即，电流除以电压)，并且传导率可以定义为每单位距离的电导。申请人先前已经在于2005年9月23日提交的同时待审的美国专利申请系列号11/233,814中描述了监测PEF治疗的方法和装置，以及示例性的PEF波形，该申请通过引用完全结合于此。
尽管图4和5的实施方案示例性地包括双极装置，但是应该理解，备选地可以使用单极装置。例如，可以将活性单极电极血管内、血管外或血管内-到-外地放置在对肾功能有贡献的靶点神经纤维附近。返回电极接地垫板可以附着到患者的外部。最后，PEF治疗可以在体内单极电极和接地垫板之间输送，以实现需要的肾神经调制。单极装置另外可以用于双侧肾神经调制。
可以理想地实现双侧肾神经调制。当与单侧进行的肾神经调制相比时，即，与在神经支配单一肾脏的神经组织上进行的肾神经调制相比较时，双侧神经调制可以在一些患者中提高治疗作用。例如，双侧肾神经调制可以进一步减少CHF、高血压、急性心肌梗死、造影剂肾病、肾病和/或其它心-肾疾病的临床症状。图6A-6H举例说明使用图5A的血管内装置进行双侧肾神经调制的方法的阶段。然而，应该理解，这样的双侧神经调制备选地可以使用图4的血管外装置、使用图5B的血管内-到-外装置而实现，或使用任何备选的血管内装置、血管外装置、血管内-到-外装置(包括单极装置)或它们的组合而实现。
如在图6A和6E中所示，引导导管GC和导线G可以推进到患者左肾动脉LRA或右肾动脉RRA内部或附近。在图6A中，导线示例性地放置在右肾动脉RRA内，但是应该理解，在图6A-6H中举例说明的双侧肾神经调制的顺序可以备选地颠倒。另外或备选地，双侧肾神经调制可以同时在对肾功能有贡献的右和左神经纤维上进行，如在图7-9中，而不是顺序地进行，如在图6中。
在导线和引导导管放置在右肾动脉中的情况下，装置300的导管302可以经由导线并且通过引导导管推进到动脉内的位置。如在图6B中所示，导管302的任选定心元件304在将导管输送到肾动脉的过程中处于减小的输送构型。在图6C中，当导管正确放置用于PEF治疗时，元件304任选地可以扩张成与血管壁接触，并且导线G可以从治疗区缩回，例如，可以从患者中移出，或者可以更近地放置在患者的大动脉内。
元件304的扩张可以使电极306位于血管内的中央和/或可以改变电极之间的阻抗。在将装置300按需要放置和展开时，PEF治疗可以以双极方式穿过电极306输送，以实现在对右肾功能有贡献的神经纤维中的肾神经调制，例如，至少部分实现右肾的肾去神经作用。如由传播线Li所示，脉冲电场可以沿着肾动脉RA的纵向维度排列，并且可以穿过血管壁。预测脉冲电场的排列和传播路径优先调制靶点肾神经的细胞，而不会不适当地影响非靶点动脉平滑肌细胞。
如在图6D中所示，在完成PEF治疗后，元件304可以折叠回到缩小的输送模式，并且导管302可以从右肾动脉RRA缩回，例如，缩回到在患者腹部大动脉内的引导导管GC内的位置。类似地，引导导管GC可以缩回到患者大动脉内的位置。缩回的引导导管可以重新放置，例如，旋转，以便其远端出口通常沿着左肾动脉LRA排列。然后导线G可以通过导管302和引导导管GC重新推进到左肾动脉LRA内的位置，如在图6E中所示(显而易见地，当接近任一个肾动脉时，任选地可以颠倒导线和引导导管的推进顺序)。
接着，导管302可以经由导线并且通过引导导管重新推进到左肾动脉内的位置中，如在图6F中所示。在图6G中，当导管正确放置用于PEF治疗时，元件304任选地可以扩张成与血管壁接触，并且导线G可以缩回到接近治疗位点的位置。然后可以以双极方式穿过电极306输送PEF治疗，例如，沿着传播线Li，以在对左肾功能有贡献的神经纤维中实现肾神经调制，例如，至少部分实现左肾的肾去神经。如在图6H中所示，在完成双侧PEF治疗后，元件304可以折叠回到缩小的输送模式，并且导管302，以及导线G和引导导管GC，可以从患者移出，以完成双侧肾神经调制程序。
如先前讨论，双侧肾神经调制任选地可以在对右肾和左肾功能有贡献的纤维上同时进行。图7A和7B举例说明用于进行同时的双侧肾神经调制的装置300的实施方案。在图7A的实施方案中，装置300包括双PEF治疗导管302，以及双导线G和引导导管GC。一个导管302放置在右肾动脉RRA内部，并且另一个导管302放置在左肾动脉LRA内部。在导管302放置在右肾和左肾动脉中的情况下，可以通过导管302同时输送PEF治疗，以获得同时的双侧肾神经调制，示例性地通过血管内途径进行。
在一个实施例中，可以在患者的右和左股动脉上产生分开的动脉解剖位点，用于经皮输送两个导管302。备选地，两个导管302可以通过单一的股动脉入口位点输送，通过双引导导管或通过单引导导管。图7B举例说明使用单个动脉解剖入口位点进行同时双侧肾神经调制的装置300的实施例。在图7B的实例中，两个导管302通过常规分成两部分的引导导管GC’进行输送，所述引导导管GC’具有分成两部分的远端区域，用于将导管302同时输送到右肾和左肾动脉。然后可以进行同时(或顺序)的双侧PEF治疗。
图8举例说明用于同时双侧肾神经调制的其它方法和装置。在图8中，血管外装置200的实施方案包括双探针210和电极212。所述电极放置在左肾动脉LRA和右肾动脉RRA的附近。PEF治疗可以通过电极212同时输送，以实现同时的双侧肾神经调制，通过血管外途径举例说明。
显而易见地，血管内-到-外装置备选地可以用于双侧肾神经调制。这样的双侧肾神经调制可以顺序地、同时地或它们的组合地进行。例如，图5B的ITEV PEF系统320可以用于双侧肾神经调制。
还可以使用用于实现肾神经调制的其它方法和装置，例如，通过局部化的药物递送(诸如通过药物泵或输注导管)或通过使用刺激电场，等。这样的方法和装置的实例先前已经，例如，描述在于2003年4月8日提交的共同所有的和同时待审的美国专利申请系列号10/408,665中，和在美国专利号6,978,174中，这两个专利都通过引用全部结合于此。
图9显示用于通过局部化药物递送实现双侧肾神经调制的方法和装置的一个实施例。在图9中，药物储器400，示意性地是可植入的药物泵，已经植入在患者内。药物递送导管402a和402b与所述药物储器连接，并且分别延伸到右肾动脉RRA和左肾动脉LRA的附近，用于递送能够调制对肾功能有贡献的神经纤维的一种或多种神经调制剂或药物。通过导管402a和402b递送药剂可以获得双侧肾神经调制。当需要时，通过导管402a和402b的这样的药物递送可以同时或顺序地进行，以及连续或间歇地进行，以分别提供同时的或顺序的，连续的或间歇的肾神经调制。
在图9装置的备选实施方案中，导管402a和402b可以仅仅临时放置在需要的位置，例如，用于从外部药物储器如注射器紧急递送一种或多种神经调制剂。这样的临时放置可以包括，例如，导管的血管内、血管外和/或血管内-到-外放置。在另一个备选的实施方案中，药物储器400可以用可植入的神经刺激器或起搏器型装置放置，并且导管402可以用耦合到神经刺激器的电导线代替，用于向靶点肾纤维输送电场，诸如脉冲电场或刺激电场。在另一个备选实施方案中，电技术可以与一种或多种神经调制剂的递送组合，以实现所需要的双侧肾神经调制。
尽管上文描述了本发明的优选的示例性变体，但是对于本领域的技术人员显而易见地可以对其进行各种改变和改进，而不背离本发明。例如，尽管主要描述了变体与脉冲电场组合使用，但是应该理解，当需要时可以输送任何其它电场，包括刺激电场或神经阻滞电场，并且可以使用任何其它备选的神经调制技术，诸如神经调制剂或药物的局部化递送。在附上的权利要求中意欲覆盖落入本发明真正的精神和范围内的所有这样的改变和改进。

Claims (60)

1.用于双侧肾神经调制的方法，所述方法包括：
调制对患者的第一个肾的肾功能有贡献的至少第一神经纤维；和
调制对患者的第二个肾的肾功能有贡献的至少第二神经纤维，由此实现双侧肾神经调制。
2.权利要求1的方法，其中调制对患者的第一个肾的肾功能有贡献的第一神经纤维还包括调制对右肾功能有贡献的右神经纤维，和
其中调制对患者的第二个肾的肾功能有贡献的第二神经纤维还包括调制对左肾功能有贡献的左神经纤维。
3.权利要求1的方法，其中调制对患者的第一个肾的肾功能有贡献的第一神经纤维还包括调制对左肾功能有贡献的左神经纤维，和
其中调制对患者的第二个肾的肾功能有贡献的第二神经纤维还包括调制对右肾功能有贡献的右神经纤维。
4.权利要求1的方法，其中调制所述第一神经纤维和调制所述第二神经纤维还包括同时调制所述第一和第二神经纤维。
5.权利要求1的方法，其中调制所述第一神经纤维和调制所述第二神经纤维还包括顺序地调制所述第一和第二神经纤维。
6.权利要求1的方法，其中调制所述第一神经纤维和调制所述第二神经纤维还包括通过放置在患者的肾血管系统内部的装置来调制所述第一神经纤维和调制所述第二神经纤维。
7.权利要求1的方法，其中调制所述第一神经纤维和调制所述第二神经纤维还包括通过放置在患者的肾血管系统外部的装置来调制所述第一神经纤维和调制所述第二神经纤维。
8.权利要求1的方法，其中调制所述第一神经纤维和调制所述第二神经纤维还包括通过放置在邻近患者的肾血管系统处的装置来调制所述第一神经纤维和调制所述第二神经纤维。
9.权利要求1的方法，其中调制所述第一神经纤维和调制所述第二神经纤维还包括通过放置在患者的肾血管系统内部并且具有从血管外传递的神经调制元件的装置来调制所述第一神经纤维和调制所述第二神经纤维。
10.权利要求1的方法，其中调制所述第一神经纤维和调制所述第二神经纤维还包括通过电场来调制所述第一和第二神经纤维。
11.权利要求10的方法，其中通过电场调制所述第一和第二神经纤维还包括将所述第一和第二神经纤维暴露于脉冲电场。
12.权利要求10的方法，其中通过电场调制所述第一和第二神经纤维还包括将所述第一和第二神经纤维暴露于刺激电场。
13.权利要求1的方法，其中调制所述第一神经纤维和调制所述第二神经纤维还包括将神经调制剂递送到所述第一和第二神经纤维。
14.权利要求1的方法，其中调制所述第一神经纤维和调制所述第二神经纤维还包括将所述第一和第二肾至少部分去神经。
15.权利要求1的方法，其中调制所述第一神经纤维和调制所述第二神经纤维还包括在所述第一和第二神经纤维中诱导选自由下列各项组成的组中的一种作用：不可逆的电穿孔、电融合、坏死、程序性细胞死亡、基因表达改变、动作电位衰减、动作电位阻滞、细胞因子上调改变、以及它们的组合。
16.权利要求1的方法，其中调制所述第一神经纤维和调制所述第二神经纤维还包括连续地调制所述第一和第二神经纤维。
17.权利要求1的方法，其中调制所述第一神经纤维和调制所述第二神经纤维还包括间歇地调制所述第一和第二神经纤维。
18.用于双侧肾神经调制的装置，所述装置包括：
第一场施加器，所述第一场施加器设置成放置在邻近对右肾功能有贡献的至少第一神经纤维处；
第二场施加器，所述第二场施加器设置成放置在邻近对左肾功能有贡献的至少第二神经纤维处；和
场发生器，所述场发生器耦合到所述第一和第二场施加器，
其中所述场发生器设置成为所述第一场施加器提供第一信号和为所述第二场施加器提供第二信号。
19.权利要求18的装置，其中所述第一场施加器和所述第二场施加器包括血管内场施加器，其设置成放置在患者的肾血管系统内部。
20.权利要求18的装置，其中所述第一场施加器和所述第二场施加器包括血管外场施加器，所述血管外场施加器设置成放置在邻近患者的肾血管系统处的外部。
21.权利要求18的装置，其中所述第一场施加器和所述第二场施加器包括血管内-到-外场施加器，所述血管内-到-外场施加器设置成通过血管内-到-外途径的血管外放置。
22.权利要求18的装置，其中所述第一场施加器和所述第二场施加器包括这样的场施加器，所述场施加器设置成下列放置的组合：在患者肾血管系统内部的放置，在邻近患者的肾血管系统外部的放置或通过血管内-到-外途径的血管外放置。
23.权利要求18的装置，其中所述场发生器还包括脉冲电场发生器。
24.权利要求18的装置，其中所述第一场施加器和所述第二场施加器包括设置成放置在邻近所述第一和第二神经纤维处的电极，并且其中所述电极耦合到所述场发生器，用于将电场输送到所述第一和第二神经纤维。
25.权利要求24的装置，其中所述第一场施加器和所述第二场施加器包括第一双极电极对和第二双极电极对。
26.权利要求24的装置，其中所述第一场施加器和所述第二场施加器包括第一单极单极和第二单极电极，所述装置还包括至少一个接地垫板，所述接地垫板设置成外部附着到所述患者。
27.权利要求24的装置，其中所述第一场施加器包括双极电极对，并且所述第二场施加器包括单极电极，所述装置还包括接地垫板，所述接地垫板设置成外部附着到所述患者。
28.权利要求24的装置，其中所述第一场施加器包括单极电极，并且所述第二场施加器包括双极电极对，所述装置还包括接地垫板，所述接地垫板设置成外部附着到所述患者。
29.权利要求18的装置，其中所述场发生器设置成同时对所述第一场施加器提供第一信号和对所述第二场施加器提供第二信号。
30.权利要求18的装置，其中所述场发生器设置成顺序地为所述第一场施加器提供第一信号和为所述第二场施加器提供第二信号。
31.权利要求18的装置，其中所述场发生器设置成连续地为所述第一场施加器提供第一信号和为所述第二场施加器提供第二信号。
32.权利要求18的装置，其中所述场发生器设置成间歇地为所述第一场施加器提供第一信号和为所述第二场施加器提供第二信号。
33.一种用于双侧肾神经调制的方法，所述方法包括：
调制对患者的右肾功能有贡献的神经纤维；和
调制对所述患者的左肾功能有贡献的神经纤维。
34.权利要求33的方法，其中调制对右肾和左肾功能有贡献的神经纤维还包括将所述患者的右肾和左肾去神经。
35.权利要求33的方法，其中调制对右肾和左肾功能有贡献的神经纤维还包括在所述神经纤维中诱导选自由下列各项组成的组的作用：不可逆的电穿孔、电融合、坏死、程序性细胞死亡、基因表达改变、动作电位衰减、动作电位阻滞、细胞因子上调改变、以及它们的组合。
36.权利要求33的方法，其中调制对右肾和左肾功能有贡献的神经纤维还包括：
将调制装置放置在所述患者的右肾和左肾血管系统内，和
用所述调制装置调制所述神经纤维。
37.权利要求33的方法，其中调制对右肾和左肾功能有贡献的神经纤维还包括：
将调制装置放置在所述患者的右肾和左肾血管系统附近，和
用所述调制装置调制所述神经纤维。
38.权利要求37的方法，其中将调制装置放置在患者的右肾和左肾血管系统附近还包括将在患者内部的所述调制装置放置在所述肾血管系统外部。
39.权利要求38的方法，其中将在所述患者内部的所述调制装置放置在肾血管系统外部还包括将在患者内部的所述调制装置通过血管内-到-外途径放置在肾血管系统外部。
40.权利要求33的方法，其中调制对右肾和左肾功能有贡献的神经纤维还包括对所述右和左神经纤维施加电场。
41.权利要求40的方法，其中对所述右和左神经纤维施加电场还包括对所述右和左神经纤维施加脉冲电场。
42.权利要求40的方法，其中对所述右和左神经纤维施加电场还包括对所述右和左神经纤维施加刺激电场。
43.权利要求33的方法，其中调制对右肾和左肾功能有贡献的神经纤维还包括将神经调制剂递送到所述右和左神经纤维。
44.权利要求33的方法，其中调制对右肾和左肾功能有贡献的神经纤维还包括同时调制对右肾和左肾功有贡献的神经纤维。
45.权利要求33的方法，其中调制对右肾和左肾功能有贡献的神经纤维还包括顺序地调制对右肾和左肾功有贡献的神经纤维。
46.权利要求33的方法，其中调制对右肾和左肾功能有贡献的神经纤维还包括连续地调制对右肾和左肾功有贡献的神经纤维。
47.权利要求33的方法，其中调制对右肾和左肾功能有贡献的神经纤维还包括间歇地调制对右肾和左肾功有贡献的神经纤维。
48.用于双侧肾神经调制的装置，所述装置包括：
第一药物递送元件，所述第一药物递送元件设置成放置在邻近对右肾功能有贡献的第一神经纤维处；
第二药物递送元件，所述第二药物递送元件设置成放置在邻近对左肾功能有贡献的第二神经纤维处；和
包括神经调制剂的药物储器，所述药物储器耦合到所述第一和第二药物递送元件，
其中所述药物储器设置成将所述神经调制剂递送到所述第一药物递送元件和所述第二药物递送元件。
49.权利要求48的装置，其中所述药物储器包括可植入的药物泵。
50.权利要求48的装置，其中所述药物储器包括外部药物储器。
51.权利要求48的装置，其中所述药物储器设置成将所述神经调制剂同时递送至所述第一药物递送元件和所述第二药物递送元件。
52.权利要求48的装置，其中所述药物储器设置成将所述神经调制剂顺序地递送至所述第一药物递送元件和所述第二药物递送元件。
53.权利要求48的装置，其中所述药物储器设置成将所述神经调制剂连续地递送至所述第一药物递送元件和所述第二药物递送元件。
54.权利要求48的装置，其中所述药物储器设置成将所述神经调制剂间歇地递送至所述第一药物递送元件和所述第二药物递送元件。
55.一种用于同时双侧肾神经调制的装置，所述装置包括：
第一刺激导管，所述第一刺激导管设置成放置在至少邻近与第一肾脏相关的第一肾动脉处，所述第一刺激导管具有至少一个第一电极；
第二刺激导管，所述第二刺激导管设置成放置在至少邻近与第二肾脏相关的第二肾动脉处，所述第二刺激导管具有至少一个第二电极；和
场发生器，所述场发生器连接到所述第一电极和所述第二电极。
56.权利要求55的装置，所述装置还包括具有腔和分为两部分的远端区域的引导导管，所述引导导管设置成放置在血管内，并且其中所述第一刺激导管在所述腔内并且设置成将所述分成两部分的远端区域的一侧突出到所述第一肾动脉中，并且所述第二刺激导管在所述腔内并且设置成将所述分成两部分的远端区域的相对一侧突出到所述第二肾动脉内。
57.权利要求55的装置，所述装置还包括设置成放置在血管内的双引导导管，所述双引导导管包括第一引导导管和第二引导导管，并且其中所述第一刺激导管是在所述第一引导导管内，并且所述第二刺激导管是在所述第二引导导管内。
58.权利要求55的装置，其中所述第一导管设置成放置在所述第一肾动脉的外部，并且所述第二导管设置成放置在所述第二肾动脉的外部。
59.权利要求55的装置，其中所述第一电极设置成接触所述第一肾动脉的内壁，并且所述第二电极设置成接触所述第二肾动脉的内壁。
60.权利要求55的装置，其中所述第一电极设置成通过所述第一肾动脉壁，并且所述第二电极设置成通过所述第二肾动脉壁。
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US20120197198A1 (en) 2012-08-02
US20140288531A1 (en) 2014-09-25
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US9486270B2 (en) 2016-11-08
US10850091B2 (en) 2020-12-01
US10179235B2 (en) 2019-01-15
US20190175903A1 (en) 2019-06-13
CN101443072B (zh) 2013-01-16
US9320561B2 (en) 2016-04-26
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US20150080885A1 (en) 2015-03-19
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US20160030736A1 (en) 2016-02-04
US9265558B2 (en) 2016-02-23
US9131978B2 (en) 2015-09-15
US20180078758A1 (en) 2018-03-22
US20140288545A1 (en) 2014-09-25
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US20160192984A1 (en) 2016-07-07

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