CN102596320B - 通过经皮超声波去肾神经治疗高血压的方法和装置 - Google Patents

通过经皮超声波去肾神经治疗高血压的方法和装置 Download PDF

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CN102596320B
CN102596320B CN201080049201.0A CN201080049201A CN102596320B CN 102596320 B CN102596320 B CN 102596320B CN 201080049201 A CN201080049201 A CN 201080049201A CN 102596320 B CN102596320 B CN 102596320B
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R·J·华金
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Abstract

本发明公开了用于阻断沿哺乳动物受试者的肾动脉延伸的肾神经以治疗高血压和相关疾病的装置和方法。例如通过将承载换能器的导管(18)的末梢端推进到肾动脉中而将超声波换能器(30)插入肾动脉(10)中。超声波换能器发射未聚焦超声波以在覆盖肾动脉的至少约0.5cm3的整个相对较大的碰撞体积(11)内将组织加热到足以阻断神经传导但不足以导致组织的快速切除或坏死的温度。可在不定位或聚焦个体肾神经的情况下执行治疗。

Description

通过经皮超声波去肾神经治疗高血压的方法和装置
相关申请的交叉引用
本申请案要求2009年10月30日申请的美国临时专利申请案61/256,429和2010年1月6日申请的美国临时专利申请案61/292,618的申请日权利，该案的公开内容以引用的方式并入本文中。
背景技术
由于种种理由高血压的成功治疗很重要。例如，高血压的成功治疗在防止或限制高血压所导致或加剧的症状(例如，肾病、心率不齐及充血性心力衰竭等)方面具有重大的临床意义。虽然药物疗法可用于治疗高血压，但是不一定成功。一些人对药物疗法治疗具有耐药性或经受来自药物疗法治疗的严重副作用。
可通过阻断围绕肾动脉的肾神经传导来治疗高血压。肾交感神经活性对高血压的发生和持续具有重大影响。当大脑感知肾神经活性增大(表明低血量或血压下降)时，其通过向心脏、肝脏和肾脏增大交感神经活性(其导致心排血量增大；胰岛素抵抗；和最重要的肾脏的肾素产量增大)来进行补偿。肾素刺激血管紧张素的分泌，血管紧张素导致血管收缩，导致血压升高；并且刺激醛甾酮的分泌。醛甾酮导致肾脏增加血液对钠和水的再吸收，增大血量，从而进一步使血压升高。
多年来已证实手术切除肾神经使血压和水潴留降至正常水平；从而使病人的心脏、肝脏和肾脏也能恢复更健康的机能。也证实中断肾神经无严重的有害作用。但是，手术切除肾神经需要大的外科手术，具有非所要的副作用风险。希望的是在无需进行大手术的情况下获得相同的效果。
为了说明与在不引发其它损伤的情况下完成此项任务相关的难处，现将描述肾动脉和肾神经的构造。图1所示的是围绕连接到肾脏6的肾动脉10的肾神经8图。肾交感神经8包括从肾脏6到大脑的肾传入感觉神经和从大脑到肾脏6的肾传出交感神经。此外，图2示出肾动脉10的横截面。肾动脉壁包括下列层：内膜3，其包括内部的单层内皮细胞；中膜5，其是动脉壁的中心；和外膜4，其是外层。还示出了位于外膜4内、肾动脉10的表面上和邻近肾动脉10的肾神经8。从这两个图中可见，肾神经8围绕肾动脉10。不同个体在肾动脉周围的不同位置上具有肾神经8。所以，肾神经可能与肾动脉的中心轴A相距不同径向距离R并且还可能位于围绕肾动脉周围C的不同位置上。通过采用解剖标记来确定肾神经的位置不切实际。此外，难以或无法使用常见的活体内成像技术定位个体肾神经。
无法定位和标定肾神经8使得难以使用非手术技术在不对肾动脉10造成损伤或导致其它副作用的情况下切断肾交感神经活性。例如，向肾神经施加能量的行为可能导致例如狭窄、内膜增生和坏死的结果。其它副作用可能包括血栓症、血小板聚集、纤维蛋白凝块和血管收缩。此外，无法标定和定位肾神经8使得难以确保肾交感神经活性被中断足以实现满意的治疗。
美国专利7,617,005建议使用连接到插入肾动脉中的导管的射频(“RF”)发射器。抵着内膜放置RF发射器并且发射RF能以将肾神经加热到降低碰巧位于发射器紧邻附近的肾神经的活性的温度。为了处理围绕肾动脉的所有肾神经，必须围绕每个肾动脉的内侧重新定位RF发射器源数次。发射器可能漏掉一些肾神经，导致治疗不完全。此外，RF能量源必须接触内膜从而能够加热肾神经，其可能造成单层内皮和内膜损伤或坏死，可能导致内膜增生、肾动脉狭窄和肾动脉剥离。
′005专利还建议使用高强度聚焦超声波来阻断肾神经。据称，所述高强度聚焦超声波能量源围绕肾动脉的轴的360°形式发射超声波能量并且无需接触内膜3。但是，高强度聚焦超声波源以围绕动脉的薄聚焦环形式施加聚焦能量。因为肾神经难以或无法用当前技术可视化和标定以及因为肾神经可能位于与肾动脉的中心轴相距不同径向距离的位置上，所以难以或无法将此薄环与肾神经对齐。对于肾动脉形状或厚度变化较大的病人而言，后一问题更严重。此外，沿神经和动脉的长度方向，薄聚焦环仅可能覆盖每个肾神经的一小部分。由于神经很容易再生长，所以小的治疗区使神经可以在较短时间周期内再接合。
多年来，超声波已被用于提高细胞修复、刺激骨细胞的生长、提高药物至特定组织的输送和使体内组织成像。此外，高强度聚焦超声波已被用于加热和切除体内的肿瘤和组织。组织切除已几乎唯一地通过高强度聚焦超声波执行，因为所发射的超声波能聚焦在特定位置上以允许精确、深入的组织坏死而不影响超声波能必须穿透的周围组织和介入结构。
授予Diederich的美国专利6,117,101论述将高度准直的超声波能而非高强度聚焦超声波用于切除组织以在肺静脉内形成疤环用于阻挡电信号至心脏的传导。
公开内容以引用的方式并入本文中的美国专利公开案20100179424(申请号12/684,067)使用未聚焦超声波治疗二尖瓣反流。在′474公开案中，用未聚焦超声波能加热和缩小与二尖瓣环相关的胶原。这种装置使用可充气气囊以将超声波换能器放置到正确位置，从而标定二尖瓣环。在这种装置中，气囊的一部分接触待加热的组织。
发明内容
本发明的一个方面提供用于阻断人类或非人类哺乳动物受试者体内的肾神经传导的装置。根据本发明的这个方面的装置宜包括被调适来插入哺乳动物受试者的肾动脉中的超声波换能器。超声波换能器需被配置来发射未聚焦超声波能。根据本发明的这个方面的装置还需包括电连接到换能器的启动器。启动器最好被调适来控制超声波换能器以发射未聚焦超声波能到覆盖肾动脉的至少0.5cm3的碰撞体积中从而以足以阻断整个碰撞体积内的肾神经传导的治疗强度施加未聚焦超声波能。如下文进一步所述，这个治疗强度低于组织切割所需的强度。
装置还可以包括具有末梢端和近端的导管，换能器安装到导管邻近末梢端的位置，导管和换能器被构造和配置来在超声波换能器定位在肾动脉内时允许大血流穿过肾动脉。导管可被构造和配置来使换能器保持不与肾动脉壁接触。导管可具有安装在邻近末梢端的位置的可伸展元件(例如气囊、网篮或类似物)。例如，换能器可被调适来以围绕换能器轴的360°圆柱形式发射超声波能，而导管可被构造和配置来使换能器轴与肾动脉轴保持大致平行。
本发明的另一个方面提供用于阻断哺乳动物受试者体内的肾神经传导的方法。根据本发明的这个方面的方法需包括将超声波换能器插入到受试者的肾动脉和启动换能器以将有治疗效力的未聚焦超声波能发射到覆盖肾动脉的至少约0.5cm3的碰撞体积中。需施加超声波能使得有治疗效力的未聚焦超声波能阻断碰撞体积中所有肾神经的传导。例如，启动换能器的步骤可为如此以在将碰撞体积内的实体组织(包括碰撞体积中的肾神经)加热到高于42℃的同时维持肾动脉壁的温度低于65℃。
因为碰撞体积相对较大以及因为整个碰撞体积内的组织宜达到足以阻断神经传导的温度，所以可在不确定肾神经的实际位置和不标定或聚焦肾神经的情况下成功执行根据本发明的这个方面的优选方法。可在不测量组织温度的情况下执行治疗。此外，宜在不导致肾动脉狭窄、内膜增生或可能需要干涉的其它伤害的情况下执行治疗。优选方法和装置可阻断肾神经的相对较长区段以减小神经恢复(该神经恢复可沿阻断区段重新建立传导)的可能性。
本发明的其它方面提供可用于在上述方法和装置中的探针和并入用于执行上述方法的步骤的构件的装置。
附图说明
图1是典型肾动脉和相关结构的解剖图；
图2是描绘肾动脉和神经的一部分的图解横截面图；
图3是描绘根据本发明的一个实施方案的装置的组件的图解视图；
图4是描绘图3所示的装置的一部分的截取图解透视图；
图5是描绘与肾动脉结合的图3和图4的装置的一部分的图解视图；
图6是描绘图3和图4的装置中所使用的组件的部分的功能、块状图解视图；
图7是描绘根据本发明的一个实施方案的方法中所使用的步骤的流程图；
图8是描绘根据图7的方法的操作期间图3和图4的装置的部分的图解视图。
具体实施方式
根据本发明的一个实施方案的装置(图3)包括护套12。护套12通常可以是细长管形式，该细长管具有近端14、末梢端16和近端至末梢端的轴15。如本公开内容中参考用于插入体内的细长元件所使用，术语“末梢端”指的是首先插入体内的一端，即元件行进至体内的前端，而术语“近端”指的是相反的末端。护套12可以是可转向护套。所以，护套可包括已知元件，例如在护套的近端和末梢端之间延伸并且连接到转向控制装置17的一个或多个牵引线(未示出)，其经配置使得操作者启动转向控制装置使护套的末梢端16在横向于轴15的方向上弯曲。
装置还包括导管18，该导管18具有近端20、末梢端22和近端至末梢端的轴，在第3图所描绘的状态中该近端至末梢端的轴与护套的近端至末梢端的轴15重合。导管的近端20需相对坚硬使得其可传递扭矩。所以，通过转动导管18的近端20，导管18的末梢端22可以绕导管18的近端至末梢端的轴旋转。
导管18的末梢端22预成形使得当导管的末梢端在护套12外时，末梢端易于呈现如第3图中22′虚线所示的钩状构造。在此情况下，末梢端22′的旋转运动将绕近端至末梢端的轴摆动弯曲部分。所以，通过旋转导管18的近端，导管18的末梢端22′可以定位为任意径向方向。
导管18具有安装在末梢端22上的气囊24。在其充气状态(图4)下，气囊24具有部分非圆形剖面，其中气囊的一部分82的直径小于肾动脉，而气囊24的另一部分80的形状为非圆形。非圆形部分具有等于或仅稍微小于肾动脉的内径的大直径DMAJ并且具有小于大直径的小直径DMIN。
超声波换能器30(图3和图5)安装在气囊24内邻近导管18的末梢端22的位置。需由陶瓷压电材料形成的换能器30是管状并且具有绕换能器30的近端至末梢端的轴33旋转的圆柱表面形式的外发射表面31。换能器30通常沿轴31具有约2mm至10mm且宜为6mm的轴长。换能器30的外径直径约为1.5mm至3mm且宜为2mm。换能器的实体结构和其安装到导管可例如如公开内容以引用的方式并入本文中的美国专利7,540,846和6,763,722所述。换能器30还具有其内表面和外表面上的导电涂层(未示出)。所以，换能器可以实体安装在金属支撑管84(图5)上，该金属支撑管84接着安装到导管。涂层电接地并且电连接到信号线32。线32从换能器30延伸穿过管腔34。管腔34在导管18的近端与末梢端之间延伸，而线32从换能器30穿过管腔34延伸到导管18的近端14。
换能器30被配置使得换能器中所产生的超声波能主要从外发射表面发射。所以，换能器可包括被配置来将超声波能朝向换能器的内部反射使得所反射的能量加强外表面上的超声波振动的部件。例如，支撑管84和换能器30可被构造使得换能器30的内表面通过间隔(未示出)与由金属形成的支撑管的外表面分隔开。跨换能器的内表面与支撑管的外表面之间间隔的距离可为换能器所发射的超声波能的波长的一半以促进换能器30的高效运行。在本实施方案中，换能器30所产生的超声波能在水隙上反射以加强传播自换能器30的超声波能，从而确保超声波能从换能器30的外表面向外导向。
换能器30还被配置来将撞击外表面31的超声波转化成线32上的电信号。换句话说，换能器30可以充当超声波发射器或超声波接收器。
换能器30被设计来例如在约1MHz至约数十MHz以及通常在约9MHz的频率下运行。换能器30的实际频率通常取决于制造公差而稍作变化。换能器的最佳启动频率可编码在机器可读元件或人可读元件(未示出)，例如附着到导管的数字存储器、条形码或类似组件。或者，可读元件可将识别个体导管的序列号或其它信息编码从而可从可通过通信链路(例如因特网)存取的中心数据库中检索最佳启动频率。
超声波系统20(本文中也被称作启动器)通过插塞接头88(图3)可释放地连接到导管18和换能器30。如图6所见，超声波系统20可包括用户界面40、并入可编程控制装置(例如可编程微处理器(未示出))的控制板42、超声波激发源44和循环装置48。用户界面40与控制板42相互作用，该控制板42与激发源44相互作用以导致按换能器的最佳启动频率经由线32发射电信号到换能器30。控制板42和超声波源44被配置来控制电信号的振幅和定时以控制换能器30所发射的超声波信号的功率级和持续时间。激发源44还被配置来检测换能器30所产生并且出现在线32上的电信号以及将此信号传达到控制板42。
循环装置48连接到导管18内的管腔(未示出)，该管腔接着连接到气囊24。循环装置被配置来使液体(宜为水性液体)穿过导管18循环到气囊24中的换能器30。循环装置48可包括例如用于在受控温度(需为体温或低于体温)下供应液体到气囊24的内部空间的用来装循环冷却剂35的储罐、泵37、冷却管(未示出)或类似物的元件。控制板42与循环装置48介接以控制进出气囊24的液体流动。例如，控制板42可包括电机控制装置，该电机控制装置连接到与泵相关的、用于控制泵37的运行速度的驱动电机。这种电机控制装置可用于例如泵37是容积式泵(例如蠕动泵)的情况。或者或此外，控制电路可包括例如连接在液压管路中用于改变管路对流体流(未示出)的阻力的可控制阀门的结构。超声波系统20还可以包括两个压力传感器38以监控穿过导管18的液体流。一个压力传感器监控液体至末梢导管18的流动以确定是否存在阻塞而另一个压力传感器监控导管18中的泄漏。当气囊处于充气状态时，压力传感器38宜在气囊中维持约3磅/平方英寸(20KPa)的所要压力。
超声波系统20并入读取器46，该读取器46用于读取导管18上的机器可读元件并且将来自此元件的信息传输到控制板46。如上所述，导管上的机器可读元件可包括例如换能器30在特定导管18中的运行频率的信息，以及控制板42可使用此信息设置合适的频率以激发换能器。或者，控制板可被配置来启动激发源44以通过在低功率级下给换能器通电同时在预定频率范围内扫描激发频率(例如8.5Mhz至9.5Mhz)以及监控换能器对此激发的回应来测量换能器运行频率。
超声波系统20可以类似于2009年10月29日申请的、名为“METHOD AND APPARATUSFOR PERCUTANEOUS TREATMENT OF MITRAL VALVE REGURGITATION(PMVR)”的美国临时专利申请案61/256,002(其公开内容以引用的方式并入本文中)中所公开的超声波系统。
图7的流程表中描绘根据本发明的一个实施方案的方法。在人类或非人类哺乳动物受试者(例如病人)准备好(步骤50)、动脉穿刺点(例如股动脉上的位置)准备好(步骤52)以及将导管18连接到超声波系统20(步骤54)后，通过将护套12的末梢端穿过穿刺点插入主动脉来将超声波换能器30插入肾动脉(步骤56)。如图8示意地描绘，当护套的末梢端定位在主动脉内时，在护套内推进导管18直到导管的末梢端从护套中突出。因为导管18的末梢端22预成形成钩状物，所以当尖端在主动脉内被朝向肾动脉10分支旋转且随后被稍微向前推或向后拉时，导管18的末梢端22可以滑入肾动脉10中。通过肾动脉/主动脉分叉的典型角度来促进此动作。基于末梢端22的钩状形状，当导管18的末梢端22在主动脉内被往回拉时容易钩住肾动脉10的分支血管。导管上的气囊24需维持未充气状态直到导管的末梢端设置在肾动脉内的所要位置上。在导管18和换能器30插入期间(步骤56)，医生可以核实换能器30被放置在肾动脉10内，但是在肾脏6或可能存在的肾动脉10的任意分支之前。可使用X射线技术(例如荧光透视法)获得此核实。
一旦导管的末梢端位于肾动脉内的适当位置，泵37即将气囊24带至如图4和图5所描绘的充气状态。在此情况下，气囊的非圆形部分80接合动脉壁，且因此位于肾动脉内的换能器30的中心，换能器的轴33(图5)大致与肾动脉的轴A同轴。但是，气囊不阻挡血流穿过肾动脉。在此情况下，循环装置48维持经冷却的水性液体流动进出气囊24以冷却换能器30。经冷却的气囊还易于冷却肾动脉的内表面。此外，血流持续穿过肾动脉帮助冷却肾动脉的内表面。气囊内的液体流动可包括X射线造影剂以协助气囊的可视化和适当放置的核实。
在下一步骤58中，超声波系统20使用换能器30测量肾动脉10的大小。控制板42和超声波源44启动换能器30以用低功率超声波脉冲“冲击”肾动脉10。此脉冲中的超声波被动脉壁反射到换能器30上作为回波。换能器30将回波转化为线32上的回波信号。超声波系统20随后通过分析回波信号确定动脉10的大小。例如，超声波系统20可以确定换能器启动之间的延时以产生回波信号的“冲击”和返回。在步骤60中，超声波系统20使用测量到的动脉大小来设置将由换能器30在后续步骤中施加治疗超声波能期间所传递的声功率。例如，控制板42可使用将特定回波延迟(以及因此动脉直径)与特定功率级相关联的查找表。通常，动脉直径越大，应当使用的功率越大。肾动脉10的形状或换能器30的居中的变化可能在回波信号中导致一系列延时。超声波系统20可取该范围的平均值以确定肾动脉10的平均大小并且基于平均大小对功率级进行调整。
医生随后通过用户界面40启动治疗(步骤60)。在处理时(步骤64)，超声波系统或启动器20和特别是控制板42和超声波源44启动换能器30以传递有治疗效力的超声波到碰撞体积11(图5)。换能器30所发射的超声波能大致从换能器30向外或远离换能器30径向传播，覆盖绕换能器30的近端至末梢端的轴33和肾动脉的轴A整圈或360°弧度。
超声波换能器30的所选择的运行频率、未聚焦特性、放置、大小和形状允许整个肾动脉10和肾神经位于换能器30的“近场”区域内。在此区域内，由换能器30产生的、向外展开、未聚焦全向(360°)圆柱形波束的超声波易于保持准直并且具有大致等于换能器30的轴长的轴长。对于圆柱形换能器，近场区域的径向范围由表达式L2/λ界定，其中L是换能器30的轴长，而λ是超声波的波长。在与换能器30表面的距离大于L2/λ的位置上，波束开始轴向展开至大的范围。但是，对于小于L2/λ的距离，波束未轴向展开至任何大的范围。所以，在近场区域内，在小于L2/λ的距离处，当未聚焦波束径向展开时，超声波能的强度与相距换能器30表面的距离成比例地线性减小。如本公开内容中所使用，术语“未聚焦”指的是强度未在波束远离换能器30的传播方向上减小的波束。
碰撞体积11大致是圆柱形并且与肾动脉同轴。其从换能器表面延伸到碰撞半径39，其中超声波能的强度太小而无法将组织加热到导致肾神经8阻断的温度范围。碰撞半径39由从换能器30发射的超声波能的剂量确定。碰撞体积11的体积V由下列等式确定：
V＝πr2 2h-πr1 2h
其中
r1＝换能器30的半径
r2＝碰撞区11的半径
h＝换能器30的长度
如上所述，换能器30的长度可在2mm与10mm之间变化，但是宜为6mm以提供宽的肾神经阻断区。换能器30的直径可在1.5mm至3.0mm之间变化，且宜为2.0mm。不仅针对其治疗效果，而且以允许碰撞体积11的半径39宜在5mm至7mm之间以覆盖肾动脉10和邻近肾神经(其都位于3mm到4mm的平均半径内)而不发射破坏性超声波能到超过肾动脉10的结构为目的选择剂量。这将导致至少0.5cm3的碰撞体积11，肾神经阻断的长度精确对应于换能器32的长度。
需选择功率级使得在整个碰撞体积内，实体组织被加热到约42℃或更高达数秒或更长时间，但所有实体组织(包括肾动脉的内膜)需保持低于65℃。所以，在整个碰撞区域内，实体组织(包括所有肾神经)被带至足以阻断神经传导但低于导致组织快速坏死的温度。
研究表明神经损伤在低得多的温度下发生且发生的速度比组织坏死快得多。见以引用的方式并入本文中的Bunch、Jared.T等人的“Mechanisms of Phrenic Nerve Injury DuringRadiofrequency AblaT.ion aT.T.he Pulmonary Vein Orifice”，Journal of CardiovascularElecT.rophysiology，第16卷，第12期，第1318至1325页(2005年12月8日)。由于组织坏死通常在处于65℃或更高的温度下达约10秒或更长时间时发生而肾神经8的阻断通常在肾神经8处于42℃或更高的温度下达数秒或更长时间时发生，所以选择超声波能的剂量以将影响体积11中的温度保持在这些温度之间达数秒或更长时间。超声波能的剂量还需低于在碰撞体积中导致胶原显著收缩所需的剂量。换能器的操作因此提供治疗剂量，其阻断肾神经8而不对肾动脉10造成损伤，例如狭窄、内膜增生、内膜坏死或可能需要干涉的其它伤害。跨肾动脉10的内壁的持续血流确保肾动脉的内膜层3(图2)被冷却。这允许按治疗剂量发射的超声波能主要在肾动脉10的外层而非内膜层3上消散并且转化为热。此外，经冷却的液体循环穿过含有换能器30的气囊24也可以帮助减小从换能器30转移到内膜层3及流经换能器的血液的热。所以，所发射的治疗未聚焦超声波能不损伤内膜且不引发血栓形成，提供更安全的治疗。
为了产生治疗剂量的超声波能，换能器30的声功率输出通常为约10瓦至约100瓦，更常见从约20瓦至约30瓦。功率施加的持续时间通常为约2秒至约一分钟或更长时间，更常见从约10秒到约20秒。可通过数学建模或动物试验确定与特定系统一起使用以实现的所要温度水平的最佳剂量。
未聚焦超声波能的碰撞体积11覆盖整个肾动脉10，包括外膜和紧密围绕的组织，并且因此覆盖围绕肾动脉的所有肾神经。所以可以不加区别地将换能器30放置在肾动脉10中以阻断围绕受试者体内的肾动脉10的所有肾神经8的传导。如本公开内容中所使用，“不加区别”和“不加区别地”指的是未标定、定位或聚焦任何特定肾神经。
根据需要，医生随后可将导管18和换能器30沿肾动脉重新定位(步骤66)并且重新启动治疗68以重新发射有治疗效力的未聚焦超声波能(步骤70)。这在沿肾动脉的长度的额外位置上阻断肾神经并且因此提供更安全和更可靠的治疗。重新定位和重新发射步骤根据需要可执行数次。接下来，医生用换能器30将导管18移动到另一个肾动脉10并且再次针对该动脉10执行整个治疗(步骤72)。在治疗完成后，将导管18从受试者身体内抽出(步骤74)。
可利用上述特征的多种变型和组合。例如，在施加治疗超声波能期间超声波系统20可控制换能器30从而以脉冲函数发射超声波能。脉冲函数导致超声波换能器30按例如50％的工作循环发射超声波能。超声波能的脉冲调制可帮助在增加治疗次数的同时限制组织温度。
在另一个变型中，可省略测量肾动脉大小和调整剂量的步骤(步骤58和72)。在此情况下，换能器仅在对于一般受试者的肾动脉足够的预设功率级下运行。在另一个变型中，可通过除启动换能器30以外的技术，例如通过使用引入肾动脉的造影剂的X射线成像或磁共振成像或使用单独的超声波测量导管测量肾动脉直径。在此情况下，来自单独的测量的数据可用于设置剂量。
在上述特定实施方案中，通过可伸展气囊24的非圆形元件80将换能器30放置在肾动脉的中心。可使用其它居中装置。例如，覆盖换能器的可伸展气囊可以是圆形横截面的直径稍微小于肾动脉10的气囊。这种气囊允许血液继续流动穿过肾动脉10，但是使换能器30大致维持在肾动脉10的中心。在本实施方案中，气囊24是动态的而非装配到肾动脉10，因为围绕气囊24的血液流动导致小的向后和向前移动。这种动态性质允许血液继续到达肾动脉10的所有部位，从而提供冷却以及使内膜3的损伤最小化。在其它实施方案中，导管的末梢端可以包括除气囊以外的可伸展结构，例如可选择性地例如通过在轴向方向上压缩结构而带至径向伸展状态的网篮或金属网结构。网篮可以对超声波无反射性或可以安装在导管上的轴向偏离换能器30的位置上。
在另一个变型中，气囊24可由多孔薄膜形成或包括孔使得在气囊24内循环的经冷却的液体可从气囊24中逸出或喷至肾动脉10内的血流中。进入血流的从气囊24中逸出或喷出的经过冷却的液体可支持与流动血液接触的肾动脉10的内膜的进一步冷却。
通常导管18是一次性、单次使用装置。导管18或超声波系统20可包含阻止在单次使用后再次使用导管18的安全装置。这类安全装置本身在本领域中已知。
在另一个变型中，导管18本身可包括允许医生直接控制导管的末梢端22方向的转向机构。护套可省略。
另一个变型可以是位于导管18的末梢端上、包括超声波换能器30的能量发射单元可以定位在肾静脉中，并且超声波换能器30可包含用于选择性地仅在有限的径向范围内将超声波能从换能器30中导出的反射或阻挡结构以提供超声波能需选择性地从肾静脉中的换能器30导向肾动脉10。当利用静脉方法时，超声波能被导向远离换能器30的外表面传播的区段或波束，通常称作侧发射换能器30配置。例如，超声波换能器30可具有一种构造并且可运行以发射类似于2009年10月29申请的、名为“METHOD AND APPARATUS FORPERCUTANEOUS TREATMENT OF MITRAL VALVE REGURGITATION(PMVR)”的美国临时申请案61/256002(其以引用的方式并入本文中)导向的超声波能5。在这个变型中，导管18引入身体及随后定位为靠近肾脏6的路径与上述动脉方法不同。可使用静脉方法以利用在导管18抽出后闭合组织较少的可能性。
虽然本文中以参考特定实施方案描述本发明，但是应了解这些实施方案只说明本发明的原理和应用。所以，应了解可在不脱离随附申请专利范围所界定的本发明的精神和范围的情况下对说明性实施方案进行多种修改以及设计其它配置。

Claims (22)

1.一种用于阻断哺乳动物受试者体内的肾神经传导的装置，其包括：
导管，其被调适来插入所述哺乳动物受试者的肾动脉中；
超声波换能器，其定位到邻近所述导管末梢端的位置，所述超声波换能器被调适来插入所述哺乳动物受试者的肾动脉中以及发射未聚焦超声波能；
启动器，其电连接到所述超声波换能器，所述启动器被调适来控制所述超声波换能器以发射治疗剂量的未聚焦超声波能到覆盖所述肾动脉的至少0.5cm3的碰撞体积中，以阻断整个所述碰撞体积内的肾神经的传导，而不对肾动脉的内膜造成损伤，其中所述启动器被调适来控制所述超声波换能器以发射所述未聚焦超声波能；以及
气囊，其安装到导管使得所述超声波换能器位于气囊内，其中所述气囊被调适来接合所述肾动脉的壁，其中，当充气时，所述气囊将所述超声波换能器放置在所述肾动脉的中心，以及液体被传递到所述气囊内以冷却所述肾动脉的内膜。
2.根据权利要求1所述的装置，其中所述启动器被调适来控制所述超声波换能器从而以不足以导致组织快速坏死的强度在整个所述碰撞体积内施加所述未聚焦超声波。
3.根据权利要求2所述的装置，其中所述碰撞体积覆盖围绕所述肾动脉的所有所述肾神经。
4.根据权利要求1所述的装置，其中所述启动器被调适来按10瓦至30瓦的声功率级发射未聚焦超声波能达10秒至30秒以在所述碰撞体积中提供100焦耳至900焦耳的吸收剂量。
5.根据权利要求1所述的装置，其中所述启动器被调适来控制所述超声波换能器以在整个所述碰撞体积内实现高于42℃的温度的同时维持所述肾动脉壁的温度低于65℃。
6.根据权利要求1所述的装置，其中所述启动器被调适来控制所述超声波换能器以按脉冲函数发射所述未聚焦超声波能。
7.根据权利要求1所述的装置，其中所述超声波换能器被调适来以沿所述肾动脉的所述轴具有至少2mm的长度的形式发射所述超声波能。
8.根据权利要求1所述的装置，其中所述超声波换能器被调适来在沿着沿所述肾动脉的所述轴具有至少2mm的长度的整个碰撞体积内施加所述治疗剂量的未聚焦超声波能。
9.根据权利要求1所述的装置，其中所述导管和超声波换能器被构造和配置来在所述超声波换能器定位在所述肾动脉内的同时允许大的血流穿过所述肾动脉。
10.根据权利要求1所述的装置，其中所述导管被构造和配置来使所述超声波换能器保持不与所述肾动脉的所述壁接触。
11.根据权利要求1所述的装置，其中所述超声波换能器具有轴，所述导管被构造和配置来使所述超声波换能器的所述轴保持大致与所述肾动脉的所述轴平行，并且所述超声波换能器被调适来以围绕所述超声波换能器的所述轴的360°圆柱形式发射所述超声波能。
12.根据权利要求1所述的装置，其中所述气囊围绕所述超声波换能器。
13.根据权利要求1所述的装置，其中所述气囊被调适来接合所述肾动脉的所述壁而基本上不阻挡血流穿过所述肾动脉的可伸展元件。
14.根据权利要求1所述的装置，其中所述超声波换能器被进一步调适来接收超声波能并且产生代表所述所接收的超声波能的信号，且所述启动器被进一步调适来：
控制所述超声波换能器以按低于所述治疗剂量的强度发射测量超声波能，从所述超声波换能器中接收代表所反射的测量超声波能的回波信号；
分析所述所接收的回波信号；和
基于所述所接收的回波信号确定所述肾动脉的大小。
15.根据权利要求14所述的装置，其中所述启动器被调适来控制所述超声波换能器以取决于所述肾动脉的所述所决定的大小来改变用于发射所述有治疗效力的未聚焦超声波能的声功率。
16.一种用于肾神经阻断的探针，所述探针包括：
超声波换能器，其被调适来发射治疗剂量的未聚焦超声波能；和
导管，其具有末梢端和近端，所述超声波换能器安装到所述导管邻近所述末梢端的位置，所述导管和超声波换能器被构造和配置来允许将所述末梢端和超声波换能器定位在肾动脉内和在所述超声波换能器定位在所述肾动脉内的同时允许大的血流穿过所述肾动脉；以及
气囊，其安装到导管，使得所述超声波换能器位于气囊内，其中所述气囊被调适来接合所述肾动脉的壁，其中，当充气时，所述气囊将所述超声波换能器放置在所述肾动脉的中心，以及液体被传递到所述气囊内以冷却所述肾动脉的内膜。
17.根据权利要求16所述的探针，其中所述导管被构造和配置来使所述超声波换能器保持不与所述肾动脉的所述壁接触。
18.根据权利要求16所述的探针，其中所述超声波换能器具有轴，所述导管被构造和配置来使所述超声波换能器的所述轴保持大致与所述肾动脉的所述轴平行，以及所述超声波换能器被调适来以围绕所述超声波换能器的所述轴的360°圆柱形式发射所述超声波能。
19.根据权利要求16所述的探针，其中所述气囊被配置来使所述超声波换能器大致保持在所述肾动脉的中心。
20.根据权利要求16所述的探针，其中所述气囊围绕所述超声波换能器。
21.根据权利要求16所述的探针，所述气囊具有非圆形部分，该非圆形部分在充气状态下具有被调适来接触所述肾动脉的所述壁的大直径并且具有小于所述肾动脉的所述直径的小直径，所述导管具有与所述气囊连通的液体内腔，所述探针进一步包括通过所述内腔与所述气囊连通用于使液体循环穿过所述气囊的循环装置。
22.一种用于阻断哺乳动物受试者体内的肾神经传导的装置，其包括：
超声波换能器，其置于气囊内；
构件，其用于将超声波换能器定位在所述哺乳动物受试者的肾动脉中；和
构件，其用于启动所述超声波换能器以发射有治疗效力的未聚焦超声波能到覆盖所述肾动脉的至少0.5cm3的碰撞体积中，并且在维持所述肾动脉壁的温度低于65℃的同时在整个碰撞体积内实现高于42℃的温度达数秒或更长时间使得所述有治疗效力的超声波能阻断设置在所述碰撞体积中的所有所述肾神经的传导而不损伤所述肾动脉的内膜。
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