CN106232043A - 具有编织轴的神经调节导管以及相关的系统和方法 - Google Patents

具有编织轴的神经调节导管以及相关的系统和方法 Download PDF

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CN106232043A
CN106232043A CN201580021124.0A CN201580021124A CN106232043A CN 106232043 A CN106232043 A CN 106232043A CN 201580021124 A CN201580021124 A CN 201580021124A CN 106232043 A CN106232043 A CN 106232043A
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CN106232043B (zh
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B·凯利
M·莫里亚蒂
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Medtronic Ardian Luxembourg SARL
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Abstract

在此披露了使用治疗性肾神经调节对患者进行治疗的方法以及相关的装置、系统和方法。本技术的一个方面例如涉及一种导管设备，所述导管设备包括由嵌在聚合物内的编织件所限定的细长轴。所述编织件可以包括与编织元件交织的一个或多个热电偶组件。这些热电偶组件可以在所述轴的远侧部分处联接到一个或多个电极上。

Description

具有编织轴的神经调节导管以及相关的系统和方法
相关申请的交叉引用
本申请要求于2014年4月24日提交的序列号为61/983,812的美国临时申请的权益，所述临时申请通过援引以其全部内容并入本文。
技术领域
本技术总体上涉及神经调节装置以及展开方法。一些实施例例如涉及神经调节导管(例如具有编织轴)以及相关的使用和制造方法。
背景技术
交感神经系统(SNS)是通常与应激反应相关的主要是非自主的身体控制系统。支配组织的SNS纤维存在于人体的几乎每个器官系统中，并且可以影响诸如瞳孔直径、肠道运动性和尿排出等特性。这种调节可以在维持体内平衡或使身体准备对环境因素做出快速反应方面具有适应性效用。然而，SNS的慢性激活是可以驱动许多疾病状态的进展的常见适应不良反应。尤其是已经在实验上和在人体中鉴别出，肾性SNS的过度激活是造成高血压、容量负荷过重(如心力衰竭)状态以及进行性肾病的复杂的病理生理学的可能因素。
支配肾脏的交感神经终止在血管、肾小球旁器和肾小管中。刺激肾交感神经可引起例如肾素释放增加、钠重吸收增加以及肾血流减少。肾功能的这些和其他受神经调节的组成部分在以增加的交感神经紧张为特征的疾病状态下受到极大刺激，并且可能促成高血压患者的血压升高。例如，由肾交感神经传出刺激引起的肾血流量和肾小球滤过率的降低可能是心肾综合征(即作为慢性心力衰竭的进行性并发症的肾功能障碍)的肾功能丧失的基础。阻断肾传出交感神经刺激的后果的药理学策略包括中枢作用的交感神经阻滞药物、β阻断剂(旨在减少肾素释放)、血管紧张素转换酶抑制剂和受体阻断剂(旨在阻断血管紧张素II以及肾素释放后的醛甾酮激活的作用)以及利尿剂(旨在抵抗肾交感神经介导的钠和水滞留)。然而，这些药理学策略具有显著的限制，包括有限的功效、顺应性问题、副作用等。
最近，已经开发了神经调节装置，其可以通过对肾血管中的靶位点施加能量场(例如经由射频消融)来减少交感神经活性，并且可以由此降低患有难治性高血压的患者的血压。许多神经调节装置利用一个或多个热电偶(“TC”)来测量电极处或电极附近的温度。在导管轴内，尤其是在具有两个或更多个电极的神经调节装置中，存在TC线可以使得所述轴体积庞大、僵硬和/或制造相对昂贵。
附图说明
参考以下附图可以更好地理解本技术的许多方面。此外，在某些视图中部件可以显示为透明的，仅仅是为了说明清楚，而不是表明所示的部件一定是透明的。附图中的部件不一定是按比例的。相反，重点在于清楚地说明本技术的原理。
图1A是根据本技术的实施例构造的神经调节系统的部分示意性图示。
图1B是沿着线1B-1B截取的图1A的导管轴的横截面端视图。
图1C是沿着线1C-1C截取的图1A的导管轴的横截面端视图。
图2A是根据本技术的处于低剖面构型的图1A所示的导管的侧视图。
图2B和图2C是图2A所示的导管的一部分轴的放大视图。
图3是具有TC组件和在相同方向上包覆的一个或多个编织元件的轴的一部分的放大侧视图，所述轴根据本技术的若干实施例进行构造。
图4是具有只包括TC组件(而不包括编织元件)的编织件的轴的一部分的放大侧视图，所述轴根据本技术的若干实施例进行构造。
图5A是处于扩张构型的轴的远侧部分的侧视图，所述轴根据本技术的实施例进行构造。
图5B是沿着图5A中的线5B-5B截取的所述轴的远侧部分的横截面端视图。
图6是在根据本技术的实施例的制造阶段中所述轴在心轴上的远侧部分的侧视图。
图7-8是示出了各种编织件构造的轴的横截面端视图，所述编织件是根据本技术进行构造的。
图9是示出了处于扩张构型的轴的轴向轮廓的端视图，所述轴根据本技术进行构造。
图10-12是示出了轴的各种轴向轮廓的示意性端视图，每个轴处于扩张构型并根据本技术进行构造。
图13是沿着线13-13截取的图2C所示的轴的横截面端视图。
图14是图2B所示的轴的放大透视侧视图，为了说明的目的移除了电极。
图15是描绘根据本技术的实施例将电极焊接到TC组件的示意性表示。
图16是根据本技术的实施例构造的具有横截面积变化的编织元件的轴的横截面端视图。
图17是示出了电极间距的处于低剖面或输送构型的轴的远侧部分的侧视图，所述轴根据本技术进行构造。
图18是图17中示出的轴的一部分的电极安放模式的示意性表示。
图19是示出了根据本技术的实施例构造的ABCD模式化的电极间距安排的表格。
图20是示出了根据本技术的实施例构造的ADCB模式化的电极间距安排的表格。
图21是示出了每英寸圈数(“PPI”)对电极间距7.5mm的电极定位误差的图。
图22-23是在根据本技术的实施例构造的快速交换端口的不同制造阶段所示的轴的侧视图。
图24是根据本技术的一个实施例构造的具有端口段的轴的横截面端视图。
图25是轴的侧视图，为了说明的目的移除编织件的一部分，所述轴示出为在制造阶段中并根据本技术的实施例构造。
图26是轴的侧视图，为了说明的目的移除编织件的一部分，所述轴示出为在制造阶段中并根据本技术的实施例构造。
图27是轴的侧视图，为了说明的目的移除编织件的一部分，所述轴示出为在制造阶段中并根据本技术的实施例构造。
图28是轴的侧视图，为了说明的目的移除编织件的一部分，所述轴示出为在制造阶段中并根据本技术的实施例构造。
图29是轴的侧视图，为了说明的目的移除编织件的一部分，所述轴示出为在制造阶段中并根据本技术的实施例构造。
图30A是在根据本技术的实施例的制造阶段中示出的轴的侧视图。
图30B是图30A所示的轴的侧视图，为了说明的目的移除编织件的一部分。
图31是具有根据本技术的一个实施例构造的快速交换端口的轴的侧视图。
图32是具有线上(over-the-wire)构型的轴的侧视图，所述轴根据本技术的实施例进行构造。
图33A是图32所示的轴的第一细长构件的放大的分隔侧视图。
图33B-33D是分别沿着图33A中的线33B-33B、33C-33C和33D-33D截取的横截面端视图。
图34是根据本技术的另一个实施例构造的具有线上构型的轴的侧视图。
图35A是根据本技术构造的导管手柄和轴的实施例的透视分解视图。
图35B是图35A所示的导管手柄的近侧部分的透视放大视图。
图36A是根据本技术的另一个实施例构造的导管的一部分的透视图。
图36B是图36A所示的导管的近侧部分的透视放大视图。
图36C是具有图36A所示的导管的连接器的透视图。
图36D是图36A所示的导管的近侧部分的透视放大视图。
图37A是根据本技术构造的细长轴的实施例的侧视图。
图37B是图37A所示的轴的近侧部分的透视放大视图。
具体实施方式
本技术涉及用于神经调节装置的展开和定位的装置和方法。本技术的一些实施例例如涉及具有编织轴的神经调节导管以及相关的系统和方法。在某些实施例中，这些神经调节导管可具有编织轴。以下参照图1A-37B描述了本技术的若干实施例的特定细节。尽管以下描述了与肾神经调节相关的系统、装置和方法的许多实施例，其他应用(例如其他非肾神经的神经调节、神经调节以外的治疗等)以及除在此描述的以外的其他实施例也在本技术的范围内。另外，本技术的若干其他实施例可以具有与在此描述的那些实施例不同的构造、部件或过程。例如，尽管关于四电极导管示出和解释了本技术，但是具有多于或少于四个电极的导管也在本技术的范围内(例如一个、两个、三个、五个等)。因此，本领域普通技术人员将相应地理解，本技术可以具有带有附加元件的其他实施例，或者本技术可以具有没有以下参照图1A-37B示出和描述的特征中的某几个特征的其他实施例。
如在此使用的，术语“远侧的”和“近侧的”限定了相对于治疗临床医师或临床医师的控制装置(例如手柄组件)的位置或方向。“远侧的”或“向远侧地”可以指远离临床医师或临床医师的控制装置的位置或在远离临床医师或临床医师的控制装置的方向上的位置。“近侧的”和“向近侧地”可以指靠近临床医师或临床医师的控制装置的位置或在朝向临床医师或临床医师的控制装置的方向上的位置。
I.系统概述
图1A是根据本技术的一个实施例构造的神经调节系统100(“系统100”)的部分示意性透视图。系统100包括经由连接器130(例如线缆)可操作地联接到能量源或能量发生器132的血管内导管110。导管110可以包括细长轴116，所述细长轴具有近侧部分114和远侧部分118、载有一个或多个电极106。导管110在近侧部分114还包括手柄组件112。细长轴116被构造成使远侧部分118血管内地定位在人类患者的肾血管内的治疗位置处或另一个合适的体腔内(例如在输尿管内)。如在图1B和图1C中的轴116的横截面端视图所示的，轴116可以是由聚合物护套202与至少部分地嵌在聚合物护套202内的多个TC组件204组成的柔性管状结构。每个TC组件204的远侧部分可以电联接到对应的电极106上。如此，TC组件204可以沿着轴116的长度延伸，并且在轴116的远侧部分118处在手柄组件112与电极106之间提供电连接。以下参照图2A-37D更详细地讨论轴116的结构和组成。
轴116还可以包括被构造成用于接纳穿过其中的导丝(未示出)的快速交换(“RX”)端口104(“端口104”)。如图1A所示，轴116可以包括从手柄112延伸至端口104的第一段216、以及从端口104向远侧地延伸至轴116的远端220的第二段218。如图1B所示，第一段216在其整个横截面中可以是基本上实心的(例如没有中心腔)。例如，第一段216可以包括大体上圆柱形的细长构件208，如心轴，其包括第一段216的中心部分。TC组件204可包覆在细长构件208的周围。细长构件208可以从轴116的近侧部分114延伸到端口104。如图1B所示，细长构件208的外部圆周217可以邻接聚合物护套202的内表面。这种构造可减小轴116的轮廓，当(例如通过手柄112)向所述轴的近侧部分114施加旋转力时改善沿着轴116的旋转力的传递，和/或改善轴116的轴向强度。在一些实施例中，第一段216可以包括具有其他形状和构造的细长构件和/或可以用一种或多种材料(例如聚合物填充物)填充。在某些实施例中，例如在包括被构造成经由线上(“OTW”)方式接纳导丝的导管110的实施例中，第一段216可以具有代替细长构件或附加于细长构件的至少一个内腔。以下参照图22-34讨论关于容纳RX和OTW构造的导管设计的进一步细节。
如图1C所示，第二段218可具有从轴116的端口104延伸至远端220的内腔206。内腔206可以被构造成在其中接纳导丝。在一些实施例中，可以在聚合物护套202的内表面上形成衬层(例如聚合物衬层)(未示出)，用以限制导丝(未示出)穿透聚合物护套202并破坏TC组件204的可能性。
在一些实施例中，第二段218的外直径可以大于第一段216的外直径(例如用以容纳导丝)。在这类实施例中，细长轴116可以在近侧方向上具有锥形的形状和/或包括第一段和第二段216、218之间的外直径逐渐升高或突然升高的台阶。在其他实施例中，第二段218可以具有的外直径小于或等于第一段216的外直径。
返回参照图1A，能量发生器132可以被构造成产生选定的形式和/或量级的能量，用于经由电极106向治疗部位输送能量。例如，在特定实施例中，能量产生器132可以包括可操作地联接到一个或多个电极106上且被构造成产生射频(RF)能量(单极或双极)的能量源(未示出)。在一些实施例中，RF能量可以是脉冲RF能量。然而，在其他实施例中，能量发生器132可被构造成产生微波能量、光能、超声能量(例如血管内递送超声、高强度聚焦超声(HIFU))、直接热能、辐射(例如红外辐射、可见辐射、伽玛辐射)或另一种合适类型的能量。
能量发生器132还可被构造成控制、监测、供应或以其他方式支持导管110的操作。例如，如踏板144等控制机构可以连接(例如气动连接或电连接)到能量发生器132上，用以允许操作者启动、终止和/或调节能量发生器的各种操作特性，例如动力输送。在一些实施例中，例如，能量发生器132可被构造成经由一个或多个电极106提供单极电场的输送。在这类实施例中，中性电极或分散电极142可以电连接到能量发生器132上，并附接到患者的外部(未示出)。在一些实施例中，代替或附加于电极106，细长轴116的远侧部分118可具有端口或其他物质递送特征，用以通过递送一种或多种化学物质来产生基于化学的神经调节。例如，合适的化学物质包括胍乙啶、乙醇、苯酚、神经毒素(例如长春新碱)或被选择用于改变、损伤或破坏神经的其他合适的试剂。在某些实施例中，可以使用化学物质的组合。
在一些实施例中，系统100包括遥控装置(未示出)，所述遥控装置被构造成是无菌的以利于其在无菌区域内的使用。所述遥控装置可被构造成控制电极106、能量发生器132和/或系统100的其他合适部件的操作。例如，所述遥控装置可以被构造成允许电极106的选择性激活。在其他实施例中，可以省略所述遥控装置，并且其功能可以结合到手柄112或能量发生器132中。
如图1A所示，能量发生器132还可以包括指示器或显示屏136。能量发生器132可以包括其他指示器，包括一个或多个LED、被构造成产生可听到的指示的装置和/或其他合适的通信装置。在图1A所示的实施例中，例如，显示器136包括被构造成从用户接收信息或指令和/或向用户提供反馈的用户接口。例如，能量发生器132可以被构造成在治疗过程之前、期间和/或之后经由显示器136向操作者提供反馈。反馈可以基于来自与细长轴116的远侧部分118相关联的一个或多个传感器(未示出)的输出，例如一个或多个温度传感器、一个或多个阻抗传感器、一个或多个电流传感器、一个或多个电压传感器、一个或多个流量传感器、一个或多个化学传感器、一个或多个超声传感器、一个或多个光学传感器、一个或多个压力传感器和/或其他感测装置。
系统100还可以包括具有例如存储器(未示出)和处理电路(未示出)的控制器146。存储器和存储装置是可以用诸如一种或多种诊断算法133、一种或多种评估/反馈算法138和/或一种或多种控制算法140等非瞬态计算机可执行指令编码的计算机可读存储介质。控制算法140可以在系统100的处理器(未示出)上执行，用以控制到所述一个或多个电极106的能量传递。在一些实施例中，针对特定患者的自动控制算法140的一个或多个参数的选择可以由在能量递送之前测量和评估一个或多个操作参数的一种或多种诊断算法133引导。所述一种或多种诊断算法133在激活所述一个或多个电极106之前向临床医生提供针对患者的反馈，其可以用于选择适当的控制算法140和/或修改控制算法140以增加有效的神经调节的可能性。
虽然控制器146结合到图1A所示的实施例中的能量发生器132中，但是在其他实施例中，控制器146可以是与能量发生器132不同的实体。例如，另外地或可替代地，控制器146可以是一个或多个个人计算机、一个或多个服务器计算机、一个或多个手持或膝上型设备、一个或多个多处理器系统、一个或多个基于微处理器的系统、一个或多个可编程消费电子设备、一个或多个数字相机、一个或多个网络PC、一个或多个微型计算机、一个或多个大型主机和/或任何合适的计算环境。
II.导管装置的选择实施例
A.细长轴的组成和结构
图2A是导管110的侧视图，其轴116的远侧部分118处于低剖面状态或输送状态，并且图2B和图2C是图2A所示的细长轴116的不同部分的放大视图。一起参照图2A-2C，轴116可以是由至少部分地嵌在聚合物护套202内的编织件205形成的细长的管状构件。编织件205例如可以包括与编织元件214交织的四个TC组件204(分别标记为TC组件204a-d)。虽然编织件205在图2A-2C中具有五个部件(四个TC组件204以及一个编织元件214)，但是在一些实施例中，编织件205可以具有多于或少于五个部件。每个TC组件204a-d的近侧部分电连接到手柄112上(以下参照图35A-37B进行更详细的描述)，并且每个TC组件204a-d的远侧部分电连接到由轴116携带的对应的电极106a-d上(以下参照图13-21进行更详细的描述)。如此，TC组件204a-d单独地被构造成测量其对应的电极106a-d处或附近的温度。
每个TC组件204a-d可以包括第一线210(单独标记为210a-d)，以及由不同金属制成的第二线212(单独标记为212a-d)。如最佳地在图2B中所见，第一线和第二线210a-d、212a-d可以包覆轴116的圆周，并且可以大体上彼此平行地安排。每个TC组件204a-d可以沿着细长轴116在近侧部分与远侧部分之间跟其他TC组件204a-d彼此物理隔离且电气隔离。在一些实施例中，第一线210a-d可以由康铜制成，并且第二线212a-d可以由铜制成(反之亦然)，使得每个TC组件204都被构造成形成T型热电偶。然而，在其他实施例中，可以使用其他类型的热电偶，和/或第一线和/或第二线210、212可以由其他材料组成。尽管显示编织件205具有四个TC组件204a-d，在其他实施例中编织件205可以包括多于或少于四个TC组件(例如一个、两个、三个、五个等)。
尽管显示编织件205具有单一的编织元件214，在其他实施例中编织件205可以包括一个以上(例如两个、三个、五个等)具有相同或不同的大小和/或结构和/或由相同的或不同的材料制成的编织元件。在一些实施例中，编织件205可以不包括任何编织元件。编织元件214可以包括聚合物材料，如单丝聚合物股线或多丝聚合物股线。另外，编织元件214可包括金属。例如，编织元件214可以是具有与温度阈值对应的形状记忆性质的金属或其他材料(例如聚对苯二甲酸乙二醇酯(PET)、聚萘二甲酸乙二醇酯(PEN)、PEN-PET等)。如以下参照图5-8进一步详细讨论的，编织元件214的全部或一部分可以被热定形为所希望的形状(例如螺旋状/螺旋形构造)，使得编织元件被构造成在细长轴116上形成所希望的扩张构型和/或增强所述轴的螺旋状/螺旋形记忆。
如图2B所示的，编织元件214和TC组件204a-d可以沿着轴116的长度交织和/或编织在一起。编织元件214可以在TC线210/212与编织元件214之间的交替相交处位于相邻TC线210/212之上230和之下232。例如，编织元件214和第一线210d可以具有“2下2上”的构造，其中编织元件214在两个连续的交叉处在第一线210的径向内侧(“下”)上与第一线210d交叉，在后续两个连续的交叉处在第二线的径向外侧(“上方”)交叉，并且在轴116的全部或一部分长度上继续这种模式。在其他实施例中，编织元件214可以安排成在一根或两根线210、212上交叉，在一根或两根线210、212下交叉，和/或根据其他模式交叉(例如“1上1下”、“3上3下”等)。另外，编织元件214和TC组件204a-d可以在相反方向(图2B)或相同方向(例如参见图3)上包覆在轴116的周围。在一些实施例中，TC组件204a-d和编织元件214包覆在轴116的周围，但是不跨越彼此的纵轴(例如参见图3)。在又其他实施例中，轴116不包括任何编织元件，并且轴116仅包括聚合物护套202和TC组件204(例如参见图4)。本领域普通技术人员将理解，轴116可以具有其他构造和/或可以包括额外的或更少的编织件205部件。
仍然参照图2B，编织件205可以具有沿着轴116的长度大体上恒定的节距P(即给定TC组件204a-d旋转一圈所需的纵向距离)。在其他实施例中，节距P可以沿着轴116的长度变化。例如，编织件205可以在轴116的远侧区域处具有更紧密的节距P而用于增加柔性，并且在近侧区域处具有更宽的节距P而用于增加刚性。同样地，可以类似地选择轴116的PPI(即连续线之间的纵向距离)，以便沿着轴116的至少一部分形成所希望的柔性和/或刚度。如以下参照图17-22更详细地讨论的，可以选择编织件节距P，以便沿着轴116实现相邻电极之间的所希望的间距。
图5A是处于扩张或展开构型的轴116的远侧部分118的侧视图，并且图5B是沿着图5A中的线5B-5B截取的横截面端视图。一起参照图5A-5B，在扩张或展开构型中，轴116的远侧部分118可以具有大体上螺旋状的/螺旋形的形状。轴116的远侧部分118可以包括放置在聚合物护套202的内腔206内的管状的、细长的形状记忆芯(例如镍钛诺)502。在制造期间，芯502可以在组装到轴116中之后在心轴602上热定形，或者在其他实施例(未示出)中，所述芯可以在安放在内腔206内之前进行热定形。
代替或附加于芯502，编织件205可以包括一个或多个编织元件214，编织元件214由形状记忆材料(例如镍钛诺)、玻璃化转变温度大于约60℃的聚合物股线等构成。可以操控任何或所有编织件205部件的定位、横截面面积和/或组成，以便在扩张的远侧段118上形成所希望的螺旋状/螺旋形的形状。例如，在一些实施例中轴116可以包括大编织元件和小编织元件214的混合物。如图7所示，轴116可包括多个大编织元件904，其具有位于轴116的一侧上的第一分组以及位于轴116的相反侧上的第二分组。较小的编织元件902可以定位在这两个分组之间。如图8所示，在一些实施例中，轴116可以包括定位在轴116的一侧上的大编织元件904的分组以及定位在轴116的相反侧上的小编织元件902的分组。在其他实施例中，轴116可以包括编织元件214的其他模式和/或构造。同样地，轴116可以包括由相同的或不同的材料制成的多个编织元件214。
图9是处于扩张构型的轴116的示意性轴向视图，示出了在电极与血管壁(未示出)之间的所希望的接触模式(由触点c表示)。在经由电极的能量递送期间，有利的是可以使电极定位在轴116上，使得当远侧部分118处于螺旋状/螺旋形扩张构型时，电极围绕螺旋状/螺旋形的圆周均匀地分布并因此围绕容器的圆周均匀地分布。在一些实施例中，有利的是可以使每个电极106位于分开的象限中。而且，如图10-11所示的，在一些实施例中轴116可以包括从轴116的圆周径向向外突出的一个或多个凸块1000。凸块1000可以对应于触点c并且增加电极与血管壁之间的接触力。
B.电极
1.电极连接
图13是沿着线13-13截取的图2C中的轴116的横截面端视图。一起参照图2B和图13，电极106可以是沿着轴116的远侧部分118轴向间隔开的分开的带状电极(单独标记为电极106a-d)。每个电极106-d的主体围绕轴116，并且每个电极106a-d的内表面1304的至少一部分接触聚合物护套202。另外，每个电极106a-d的至少一部分接触其对应的TC组件204a-d(例如分别在210c和212c处)。例如，如果TC组件204a对应于电极106a，则电极106a的内表面1304接触第一线和第二线210a、212a中的每一个的至少一部分。因为第一线和第二线210、212彼此平行延伸并且沿着它们的长度以大致恒定的距离分开，所以第一线210与电极106接触的部分可以与第二线212的沿着电极106的内表面1304与电极106接触的部分分离。典型的热电偶需要在热电偶的测量端的两根线之间有一个结点。电极106(其可以包括一种或多种金属，例如金)可以用于在两个分离的线触点之间有效地传输电流。因此，线210、212之间的距离可以对测量温度的精度具有可忽略的影响。因此，第一线和第二线210、212可以被构造成测量电极106处或附近的温度。
图14示出了轴116的一部分，为了说明的目的移除了电极106。为了优化电极106与TC组件204之间的接触，轴116可以包括围绕其圆周延伸的凹槽702，其对应于电极106的安放。在制造期间，可以移除(例如经由激光消融或其他合适的方法)凹口702内的聚合物护套202的附加部分以形成凹进部分704。如图14所示，凹进部分704可在凹口702的一部分内形成菱形凹槽，所述部分使目标TC组件204a-d的第一线和第二线210、212的一部分暴露。因此，在凹进部分704内，聚合物护套202可以围绕线210、212的径向内部部分，使得聚合物护套202在暴露部分处与线210、212的主体相交。在图13和图14所示的实施例中，凹进部分704朝向聚合物护套202的内部延伸至其径向距离(从内腔206的中心进行测量)大致等于这些线210、212中一者或两者的中心与内腔206的中心之间的径向距离。
应当理解，凹口702和/或凹进部分704可以具有其他形状和/或构造。例如，在一些实施例中，凹口702可以仅围绕轴116的圆周的一部分延伸。在图14所示的实施例中，凹口702的周边706大体上是线性的。在其他实施例中，凹口702的周边706的至少一部分可以是非线性的(例如正弦形、之字形等)。在某些实施例中，轴116不具有任何凹口，并且凹进部分704形成在轴116的外表面上。此外，凹进部分704可以形成为任何合适的形状(例如圆形、正方形、星形等)。
为了将单独的电极106a-d电联接到它们各自的TC组件204a-d上，每个电极106a-d可以围绕轴116放置并且定位在其相应的凹口704内。然后可以模锻电极106的全部或一部分，使得电极106的内表面1304被推动得更靠近和/或被促使与第一线和第二线210、212的暴露部分接触。如图15中示意性地示出的，一旦正确定位和模锻，每个电极106可以在焊接点w处焊接到线210、212的对应的暴露部分上。然而，在其他实施例中，可以使用其他合适的技术将电极106联接到线210、212上。如以下更详细地讨论的，在一些实施例中，可能有利的是在电极106上的大致中心位置处进行焊接，用以避免外围处的电极材料的劣化。
可以利用几种技术来增强电极106和线210、212之间的电连接和/或机械连接。例如，为了增强电极106的内表面与第一线和第二线210、212之间的结合，替代或附加于焊接，可以将导电填料(未示出)注入凹进部分704中。还有，为了增加电极与第一线和第二线210、212之间的表面接触，可以操控任何或所有编织件205部件的定位、横截面积和/或组成，用以将线210、212选择性地定位得靠近聚合物护套202的外表面。例如，可以选择编织元件214的直径和编织元件214(相对于第一线和/或第二线210、212)的定位，用以影响第一线和/或第二线210、212的定位。如图16所示，例如，轴116可以包括至少一个编织元件214，所述编织元件具有在径向上定位在第一线210和/或第二线212下方的较大的横截面积904。预期较大的编织元件904有助于将第一和/或第二线210、212定位得更靠近聚合物护套202的外表面。以类似的方式，单丝或多丝编织元件的选择可以影响电极定位。同样地，具有圆形横截面区域的编织元件可以径向向外推动第一线和/或第二线210、212，而具有扁平横截面区域(例如矩形、椭圆形等)的编织元件可以在聚合物护套202中占据较小的径向空间。可以任何组合的方式利用任何或上述引用的技术。
2.电极间距的算法
为了有效的治疗，可能有利的是沿着目标血管的长度产生整个圆周的损伤部。例如，远侧部分118可以被构造成形成一个损伤部或一系列损伤部(例如螺旋状/螺旋形损伤或不连续损伤)，其整体为圆周、但在治疗位置的纵向段处通常是非圆周的。如以上参照图2A和图9所讨论的，电极106可以沿着轴116的远侧部分118定位，使得当轴116处于扩张构型时，电极围绕螺旋状的/螺旋形的形状圆周均匀地分布到四个象限中。如图17所证明的，可以选择沿着轴116的相邻电极之间的距离ES，以便实现处于扩张构型中的电极的这种圆周分布。例如，对于约3mm和约8mm之间的血管直径，沿着轴116的相邻电极之间的距离ES可以是约7.5mm。然而，在其他实施例中，电极间距ES可以变化。
由于沿着轴116的长度的线210、212的编织和/或包覆构造，必须考虑几个参数以便实现所希望的电极间距ES。例如，相邻线之间的距离d、带状电极的尺寸以及焊接参数可以影响电极间距ES。为了说明这个概念，图18示出了轴116的远侧部分118的一段，其包括围绕轴116包覆的第一TC组件、第二TC组件、第三TC组件和第四TC组件204a-d、以及分别在焊接点1202a和1202b处焊接到的第一TC组件和第二TC组件的第一电极和第二电极106a、106b(示意性地示出)。如果相邻线之间的距离d太小(即线非常紧密地缠绕在一起)，则特定电极的焊点将会太靠近在一起并且可能重叠。如果距离d太大(即线缠绕得分开太远)，则焊接点中的一个或两个可能太靠近电极的周边，这可能导致有缺陷的焊缝(例如没有足够的金属用于有效的焊缝)。因此，可能有利的是在电极的中心部分处具有间隔开的焊接点，如图18所示。另外，可能有利的是在单个平面中形成焊接点(例如为了易于制造)。
图19是示出了ABCD模式化的电极间距安排的表，图20是示出了ADCB模式化的电极间距安排的表。字母“A”、“B”、“C”和“D”各自代表图17和图18所示的相应的TC组件204a-d，并且每一行示出TC组件焊接点之间的不同间距。因为每个TC组件204a-d只能联接到单个电极上，在每一行中，“A”、“B”、“C”和“D”中仅有一个被框包围(表示联接到其对应的电极上的TC组件的部分)。例如，图19的第一行表示其中电极被焊接到TC组件204a-d的连续的紧邻部分的配置。在这种构造中，在焊接点(由最右列表示)之间存在“两步”。本文所使用的“两步”表示从具有焊点的TC组件到具有焊点的下一个TC组件的一次移动(“两步”是因为每个线计数为一步，并且每个TC组件可以包括两个线)。在图19的第二行中，焊接点跳过紧邻的TC组件，并且替代地位于下一个出现的TC组件上(10步)。在图19和图20的其余部分中继续这种模式。
基于图19和图20中的示例性ABCD和ADCB模式所示的步数，可以通过将电极之间的步数和所希望的距离d代入到以下等式中来确定所希望的编织密度PPI(“每英寸圈数”)：
电极定位误差E＝电极间距ES–(步数*d)；
相邻线之间的距离d(以mm计)＝25.4/PPI mm；以及
电极定位误差E＝电极间距ES–(步数*(25.4/PPI mm))。
图21是示出了对于电极间距ES是7.5mm的PPI对电极位置误差E的图。如本文中参照图21所使用的，“误差”是指实际电极间距与所希望的电极间距(例如7.5mm)之间的绝对差。在图21所示的图中，对于ABCD模式，电极定位误差E在34PPI和48PPI左右最低，而ADCB模式在61PPI和74PPI左右最低。然而，根据所需的电极间距ES和电极的尺寸，这些PPI值中的一个或多个可能仍然是不希望的。例如，34PPI仍然可能导致相邻线之间的距离太大，并且74PPI仍然可能导致相邻线之间的距离太小。因此，在其他实施例中，可以使用其他合适的安排和/或间距。
C.导丝容纳件的选择实施例
1.快速交换端口的实施例
如以上参照图1A-1C所讨论的，细长轴116可以包括端口104，端口104构造成以快速交换构型接纳导丝。现在参照图22，轴116的内腔206可以具有在远侧方向上朝向外轴116径向向外延伸的成角度部分。可以通过围绕心轴模制聚合物护套或通过其他合适的方法(例如飞秒激光、钻孔、消融等)形成所述成角度部分。可以通过在沿着轴116的与端口1604的所希望位置对应的位置处移除编织件205和/或聚合物护套202的一部分来制成轴116中的开口1604。如图23所示，可以加热聚合物护套202以软化聚合物202并回流聚合物材料，以便在端口1604与内腔206之间平滑过渡。另外，图24是具有保留用于形成快速交换端口的非编织部分1702的轴116的一个实施例的横截面端视图。
图25是根据本技术的实施例的在制造阶段期间的轴116的侧视图。如图25所示，轴116的近侧部分可以包括细长构件208，并且所述轴的远侧部分可以包括内腔206。细长构件208可以包括锥形的远侧部分1806。聚合物填充物1808可以邻接远侧部分1806的锥形表面并限定编织件/聚合物护套202、205、内腔206与远侧部分1806之间的区域。聚合物填充物1808可以由与用于聚合物护套202相同的聚合物和/或不同的聚合物制成。可以通过消融、钻孔或其他合适的方法移除锥形表面之间的编织件/聚合物护套205、202的一部分和聚合物填充物1808的一部分以形成端口(通常在位置1804处)。
图26是根据本技术的另一个实施例的制造阶段期间的轴116的侧视图。轴116可以大致类似于上面参照图25描述的轴116，只是替代于具有聚合物填充物1808，轴116可以包括在锥形表面与编织件/聚合物护套外部202、205之间的插塞1902。插塞1902可以由聚合物(不同于用于聚合物护套202的聚合物)或一旦聚合物护套202流过编织件205上并定形即可移除的金属制成。因此，插塞1902的移除形成了与轴116的远侧部分处的内腔206处于流体连通的新形成的开口(通常在位置1804处)。
图27是根据本技术的另一个实施例配置的在制造阶段期间的轴116的侧视图。如图27所示，轴116的近侧部分可以包括细长构件208，并且所述轴的远侧部分可以包括内腔206。细长构件208可以包括锥形远侧部分1806。如图27-28所示，可以移除与锥形远侧部分1806对准的编织件/聚合物护套202、205的一部分2002，在轴116中形成与内腔206处于流体连通的开口2104。如图29所示，在一些实施例中，还可以移除细长构件208的一部分2202以产生到内腔206的更平滑的过渡。
图30A是根据本技术配置的制造阶段期间的轴的侧视图，并且图30B是图30A所示的轴的相反侧视图，为了说明的目的编织件/聚合物护套205、202的一部分被移除。一起参照图30A-30B，在制造期间，可以围绕在远端具有成角度部分的细长管状构件2302(例如心轴、海波管(hypotube)等)形成轴116的编织部分。构件2302的大体上线性的部分可以用于在轴116的远侧部分118形成中心腔206(未示出)，并且所述成角度部分可以在轴116的外部形成在内腔206(未示出)与开口2304(图31)之间的连接。如图31所示，一旦编织完成并且聚合物定形，可以移除构件2302以形成被构造成用作快速交换端口的开口2304。
2.线上(“OTW”)实施例
图32示出了根据本技术构造的导管轴116，其被构造成接纳处于线上(“OTW”)构型的导丝。轴116可以包括围绕第一管状构件208的编织件/聚合物外部2504以及第二管状构件2502。如在图33A(以及相应的横截面端视图33B-33D)中的第一构件208的分离视图中最佳示出的，第一构件208可以具有远侧部分2508，其在近侧至远侧方向上逐渐变细以增加柔性以及在第一构件208与第二构件2502之间的更平滑的过渡。第二构件2502的近侧部分可以定位在至少第一构件208的远侧部分2508之上。因此，第一构件208的内腔(未示出)可以与第二构件2502的内腔(未示出)邻接。第一构件208和第二构件2502的组合内腔形成了被构造成接纳通过其中的导丝的轴腔。
图34示出了根据本技术构造的导管轴3416的另一个实施例，其被构造成接纳处于线上(“OTW”)构型的导丝。除了图34的轴3416包括定位在第一构件208的锥形远侧部分2508内的第三管状构件2506之外，轴3416大体上可以类似于以上参照图32-33D所述的轴3416。如此，第三构件2506的至少一部分夹在第一构件208与第二构件2502之间，从而在第一构件208与第二构件2502之间的过渡处提供增加的支撑。在一些实施例中，可以对第二构件和第三构件2502、2506施加热量以增加它们之间的结合。
D.手柄组件的选择实施例
图35A是图1A所示的导管110的分解透视图，而图35B是轴116的近侧部分114的放大视图。一起参照图35A和图35B，轴116的近侧部分114可以经由卡扣安排可操作地联接到手柄112上。轴116的近侧部分例如可包括定位在轴116的外部部分上且电联接到TC组件204a-d的第一线和第二线210、212上的多对导体(称为3104a-d)。例如，轴116的近侧部分114可以包括电联接到对应的第一线210上的四个第一导体2210(称为导体2210a-d)，以及电联接到对应的第二线212上的四个第二导体(称为导体2212a-d)。在其他实施例中，根据电极的数量，近侧部分115可以包括总数多于或少于八个的导体。此外，一个导体(而不是一对导体)可以对应于一对第一和第二线(例如210a和212b等)。虽然在所示的实施例中，导体以与电极对应的顺序示出(例如从远侧到近侧，“a”是最远，“d”是最近)，但是在其他实施例中，导体2210、2212可以具有任何顺序；导体3104a-d的顺序不一定对应于电极106a-d的顺序。
仍参照图35A-35B，手柄112包括壳体2202，其包括两个互补的半部2202a和2202b(为了便于描述，仅示出了2202a的内部)。每一半包括轴接纳区域2204、路由部分2240以及连接器附件2206。轴接纳区域2204可以包括纵向凹槽2226和多个导电销2220a-d和2222a-d(合称为2221)，每个导电销具有至少部分地位于凹槽2226内的马蹄铁形部分2228。凹槽2226可以被构造成接纳轴116的近侧部分114，并且销2221的马蹄铁形部分2228可以被构造成接合所接纳的轴116上的导体2220a、2210a的至少一部分。当轴116在接纳区域2204的凹槽2226内(在对准导体和销之后)被压入就位时，导体2220a、2210a接合相应的销2220a-d、2222a-d，从而将轴116电联接到手柄112上。马蹄铁形部分2228最初抵抗轴进入凹槽的运动；然而，经过某一阈值后，马蹄铁形部分2228被强制打开并允许所述导体坐落于所述马蹄铁形部分内以牢固地保持轴116(例如“卡扣配合”)。
如图35B最佳所示，一旦轴的近侧部分114在接纳区域2204内就位，则所述轴的近侧尖端2225可以焊接到安装在壳体2202内的板2224上。例如，可以从轴116的近侧尖端(未示出)上移除编织件205和聚合物护套202，从而暴露心轴2225，所述心轴然后可以被焊接到板2224上。如此，心轴2225的近侧部分可以固定到手柄112的内部部分上，以便改善轴116的扭矩响应(例如通过减小和/或防止轴116相对于手柄112的轴向和旋转运动)。
导电销2220a-d、2222a-d可以电联接到路由部分2240上(图35A)，所述路由部分包括分别对应于导电销2220a-d、2222a-2222d的多条路由线2230a-d、2232a-d。路由线2230a-d、2232a-d联接到位于手柄112的近侧部分处的连接器附件2206上，如图35A所示。连接器附件2206被构造成与连接器130可操作地连接(参见图1A)，用以将手柄112电连接到能量发生器132或系统的其他部件上。
图36A是根据本技术构造的导管2310的另一个实施例的侧视图，而图36B是图36A所示的手柄2300的近侧部分114的放大横截面视图。除以下描述的内容以外，导管2310可以大体上与以上参照图1A-1C和图35A-35C描述的导管110相似。一起参照图36A和图36B，导管2310可以包括手柄2300，其具有将印刷电路板(“PCB”)直接印刷在其上的内表面。多条路由线2318可以从PCB延伸到在手柄2300的远端处的凹进的接纳区域2320。路由线2318可以独立地对应于第一线210、第二线212和/或TC组件204(图1B)。连接器2330(图36C)可以联接到PCB板的近侧部分，从而提供手柄2300与能量发生器132之间的电连接。如图36D所示，可以移除聚合物护套2302的近侧段的一部分，用以暴露TC组件204的近端。因此，轴2316的近侧部分处的暴露的线2304可以被压入接纳区域中的适当位置，从而将轴116电联接到手柄112上。此外，心轴2326的近端(在图36B中示意性地示出)可以固定到手柄112上的板2322上，以改进轴2316的扭矩响应。在这些和其他实施例中，手柄112的远侧部分2324可以在远侧方向上延长，以改进轴2316的扭矩响应，并且增加使用者可抓握的和控制手柄112的表面积。
图37A是根据本技术构造的导管3600的另一个实施例的侧视图，图37B是图37A的导管3600的导管轴116的近端的放大视图。一起参照图37A-37B，除了导管3600具有联接到轴116的近端上的盘形连接器3652以外，导管3600可以大致类似于以上参照图1A-1C、图35A-35C和图36A-36C描述的导管110和2310。连接器3652可以电联接到TC组件(未示出)上，并且在盘3652的外部部分处提供对应于TC组件的一个或多个连接点3650。连接器(未示出)可以联接到盘3652，并且在轴116与手柄112(图1A)和/或能量发生器132(图1A)之间延伸。
III.神经调节
神经调节是例如支配器官的神经的部分或完全失能或其他有效破坏。作为示例，肾神经调节是支配肾脏的神经的部分或完全失能或其他有效破坏。具体地，肾神经调制包括抑制、减少和/或阻断沿支配肾脏的神经纤维(即传出和/或传入神经纤维)的神经沟通。这种失能可以是长期的(例如永久的或持续数月、数年或数十年)或是短期的(例如持续数分钟、数小时、数天或数周)。预期肾神经调节可对特征在于总体交感神经活性增加的几种临床病症进行有效治疗，特别是与中枢交感神经过度刺激相关的病症，例如高血压、心力衰竭、急性心肌梗死、代谢综合征、胰岛素抵抗、糖尿病、左心室肥大、慢性和终末期肾病、心力衰竭中的不适当的液体潴留、心肾综合征、骨质疏松症和猝死等。传入神经信号的减少通常有助于交感神经张力/驱动的系统性减少，并且预期肾神经调制可用于治疗与全身性交感神经过度活动或过度活跃相关的几种病症。肾神经调节可能潜在地有益于交感神经支配的各种器官和身体结构。
热效应可以包括热消融和非消融性热变或损伤(例如经由持续加热和/或电阻加热)，以部分或完全破坏神经传输信号的能力。例如，期望的热学加热效应可包括将目标神经纤维的温度升高到期望阈值以上以实现非消融性热变，或者高于更高温度以实现消融性热变。例如，对于非消融性热变，目标温度可以高于体温(例如约37℃)，但是低于约45℃，或者对于消融性热变，目标温度可以为约45℃或更高。更具体地，暴露于超过约37℃的体温但低于约45℃的温度的热能可经由对目标神经纤维或灌注目标纤维的血管结构进行适度加热而诱发热变。在血管结构受到影响的情况下，目标神经纤维可能被拒绝灌注，导致神经组织坏死。例如，这可能引起纤维或结构中的非消融性热变。暴露于高于约45℃或高于约60℃的温度下的热量可经由对纤维或结构的大幅加热而诱发热变。例如，这种较高的温度可以对目标神经纤维或灌注目标纤维的血管结构进行热消融。在一些患者中，可能希望达到对目标神经纤维或血管结构进行热消融但是低于约90℃、或低于约85℃、或低于约80℃和/或低于约75℃的温度。其他实施例可以包括将组织加热到各种其他合适的温度。不管用于诱导热神经调节的热暴露的类型如何，预期肾交感神经活性(RSNA)减少。
可以使用各种技术用以使神经通路(例如支配肾脏的神经通路)部分或完全丧失能力。向组织有目的地施加能量(例如RF能、机械能、声能、电能、热能等)和/或从组织有目的地去除能量(例如热能)可以诱导对组织的局部区域的一个或多个所希望的热学加热和/或冷却效果。所述组织，例如可以是肾动脉组织以及肾丛相邻区域(紧密地位于肾动脉的外膜内或邻近肾动脉的外膜)的组织。例如，有目的地施加和/或移除能量可以用于沿着全部或部分肾丛实现治疗有效的神经调节。
许多当前的螺旋状或螺旋形神经调节系统主要是从远侧到近侧方向展开。通常，电极阵列的远端在近侧和远侧方向上是可移动的，但是电极阵列的近端相对于导管轴是固定的。因此，在血管中或在具有锥形直径的血管部分(例如肾动脉)中，许多装置首先向血管直径较小之处的远侧展开，这可以防止在螺旋状结构的近端处的电极与内血管壁接触。同样地，沿着螺旋状或螺旋形装置的实质性长度实现与血管壁的接触在具有曲折的或不可预测的形态的血管中可能是困难的。为了满足这种需要，本技术提供了装置、系统和方法的若干实施例，提供螺旋状或螺旋形装置的双向展开以更好地将电极定位成与血管壁并置。
IV.示例
以下示例是本技术的若干实施例的说明：
1.一种导管设备，包括：
细长管状轴，所述细长管状轴具有近侧部分和远侧部分，其中，所述细长管状轴包括-
聚合物材料；
第一热电偶组件，所述第一热电偶组件包覆在所述轴的所述聚合物材料周围和/或嵌在所述轴的所述聚合物材料内，其中，所述第一热电偶组件包括由不同金属组成的第一对线；
第二热电偶组件，所述第二热电偶组件包覆在所述轴的所述聚合物材料周围和/或嵌在所述轴的所述聚合物材料内，其中，所述第二热电偶组件包括由不同金属组成的第二对线，并且其中，所述第二对线沿着所述细长轴在所述近侧部分与所述远侧部分之间与所述第一对线物理隔离且电气隔离；
第一电极，所述第一电极位于所述细长轴的所述远侧部分处并电联接至所述第一热电偶组件；
第二电极，所述第二电极位于所述细长轴的所述远侧部分处并电联接至所述第二热电偶组件，
其中，所述轴的所述远侧部分与所述第一电极和第二电极一起限定治疗组件，所述治疗组件被适配为位于病人血管内的目标位置处，
其中，所述细长轴与所述治疗组件一起穿过其中限定被构造成可滑动地接纳医用导丝的导丝腔，
其中，所述导丝相对于所述治疗组件的轴向运动使所述治疗组件在(a)低剖面输送构型与(b)具有螺旋形状的展开构型之间变换。
2.如示例1所述的导管设备，进一步包括：
第三热电偶组件，所述第三热电偶组件螺旋状地包覆在所述轴的所述聚合物材料周围和/或嵌在所述轴的所述聚合物材料内，其中，所述第三热电偶组件包括第三对线；
第四热电偶组件，所述第四热电偶组件螺旋状地包覆在所述轴的所述聚合物材料周围和/或嵌在所述轴的所述聚合物材料内，其中，所述第四热电偶组件包括第四对线；
第三电极，所述第三电极位于所述细长轴的所述远侧部分处并电联接至所述第三热电偶组件；以及
第四电极，所述第四电极位于所述细长轴的所述远侧部分处并电联接至所述第四热电偶组件，
其中，所述第一对线、第二对线、第三对线和第四对线都沿着所述细长轴在所述近侧部分与所述远侧部分之间彼此物理隔离且电气隔离。
3.如示例1或示例2所述的导管设备，其中，所述第一电极、第二电极、第三电极和第四电极包括金带电极。
4.如示例1-3中任一项所述的导管设备，其中，各个电极沿着所述细长轴彼此间隔开7.5mm。
5.如示例1-4中任一项所述的导管设备，进一步包括手柄，所述手柄经由卡扣配合安排而联接至所述细长轴的近侧部分。
6.如示例5所述的导管设备，其中，所述手柄的所述近侧部分包括安排在其上并与所述第一热电偶组件和第二热电偶组件的相应的各个线电接触的四个触点，并且其中，所述触点被定位成当所述轴的所述近侧部分与所述手柄以卡扣配合安排来联接时与由所述手柄携带的相应的多个销配对(mate)。
7.如示例6所述的导管设备，其中，所述触点是金触点。
8.如示例1-7中任一项所述的导管设备，进一步包括快速交换端口，所述快速交换端口沿着所述轴位于所述轴的所述近侧部分与所述远侧部分之间并与所述导丝腔连通，其中，所述轴的在所述快速交换端口与所述轴的近侧部分之间的部分是实心的。
9.如示例1-8中任一项所述的导管设备，其中：
在所述快速交换端口与所述轴的所述远侧部分之间，所述轴具有第一外直径；以及
在所述快速交换端口与所述轴的所述近侧部分之间，所述轴具有小于第一外直径的第二外直径。
10.如示例1-9中任一项所述的导管设备，其中，所述细长轴进一步包括与所述第一热电偶组件和第二热电偶组件的线穿插散布的单丝。
11.如示例1-10中任一项所述的导管设备，其中，所述第一热电偶组件和/或第二热电偶组件在所述轴的所述近侧部分处具有第一节距，并且在所述轴的所述远侧部分处具有第二节距，其中，所述第一节距小于所述第二节距。
12.如示例1-11中任一项所述的导管设备，其中，轴进一步包括包覆在所述轴周围的编织元件。
13.如示例12所述的导管设备，其中，所述编织元件与所述第一热电偶组件和/或第二热电偶组件交织。
14.一种神经调节导管，包括：
细长的聚合物轴，所述聚合物轴包括在其周围安排的多个热电偶丝；以及
多个神经调节元件，所述神经调节元件在所述聚合物轴的远侧部分可操作地联接至所述聚合物轴，其中，各个神经调节元件电联接至相应的热电偶丝对，
其中-
每个热电偶丝沿着围绕所述聚合物轴的纵轴延伸的螺旋状路径分布，并且其中，沿着所述聚合物轴延伸的热电偶丝大体上彼此平行地安排，以及
所述聚合物轴的至少一部分包括穿过其中的内腔，其大小和形状被设定成可滑动地接纳医用导丝。
15.如示例14所述的神经调节导管，其中，所述聚合物轴包括在其周围安排的四对热电偶丝，并且其中，所述多个神经调节元件包括电联接至相应的热电偶丝对的四个金电极。
16.如示例14或示例15所述的神经调节导管，其中，所述聚合物轴包括沿着所述轴的第一区域和第二区域，并且其中，所述螺旋状路径包括贯穿所述第一区域的第一节距以及贯穿所述第二区域的与所述第一节距不同的第二节距。
17.如示例14-16中任一项所述的神经调节导管，其中，所述聚合物轴的所述远侧部分能够在低剖面输送状态与具有大体上螺旋状/螺旋形构造的扩张的展开状态之间变换。
18.一种制造医用装置的方法，所述方法包括：
将第一热电偶组件和第二热电偶组件定位在中心心轴的周围，其中，所述第一热电偶组件包括第一对线，并且所述第二热电偶组件包括第二对线；
沿着所述心轴编织所述第一热电偶组件的第一线以及所述第二热电偶组件的第二线，其中，第一线和第二线彼此间隔开并以螺旋样式沿着所述心轴安排；
将聚合物材料放置在经编织的第一线和第二线上，以在所述心轴周围形成细长管状轴；
选择性地移除所述细长轴的远侧区域处的所述聚合物材料的多个部分，以接近所述第一热电偶组件的所述第一线和所述第二热电偶组件的所述第二线；
将第一电极电联接至所述第一热电偶组件的所述第一线的暴露部分；
将第二电极电联接至所述第二热电偶组件的所述第二线的暴露部分；以及
从至少所述细长轴的所述远侧区域中移除所述心轴。
19.如示例18所述的方法，进一步包括：在从至少所述远侧区域中移除所述心轴之后，将所述细长轴的所述远侧区域以螺旋构造定位在心轴的周围，并且其中，所述方法进一步包括将所述远侧区域热定形成螺旋形状。
20.如示例18或示例19所述的方法，其中：
将第一电极电联接至所述第一线的暴露部分包括：将所述第一电极激光焊接至所述各个第一线；以及
将第二电极电联接至所述第二线的暴露部分包括：将所述第二电极激光焊接至所述各个第二线。
21.如示例18-20中任一项所述的方法，其中，所述细长轴的所述远侧区域包括穿过其中的导丝腔，并且其中，所述方法进一步包括形成沿着所述细长轴并与所述导丝腔连通的快速交换接入端口，其中，所述快速交换接入端口和所述导丝腔的大小和形状被设定成可滑动地接纳医用导丝。
22.如示例18-21中任一项所述的方法，其中，从至少所述细长轴的远侧区域中移除所述心轴包括：只从所述轴的在所述快速交换接入端口远侧的部分中移除所述心轴，使得所述轴的在所述快速交换接入端口近侧的部分穿过其中是实心的。
VI.结论
本技术的实施例的上述详细描述仅仅是为了说明的目的，并不旨在是详尽无遗的或将本技术限于以上披露的一种或多种精确形式。如相关领域的技术人员将认识到的，在本技术的范围内的各种等效修改都是可能的。例如，虽然可能以给定的顺序呈现步骤，但是替代实施例可以用不同的顺序执行步骤。本文描述的各种实施例及其元件也可以组合以提供另外的实施例。在一些情况下，没有详细示出或描述公知的结构和功能，以避免不必要地模糊本技术的实施例的描述。
从上述内容可以理解，为了说明的目的，本文已经描述了本技术的具体实施例，但是没有详细示出或描述公知的结构和功能，以避免不必要地模糊本技术的实施例的描述。在上下文允许的情况下，单数或复数术语还可以分别包括复数或单数术语。
本技术的某些方面可以采取计算机可执行指令的形式，包括由控制器或其他数据处理器执行的例程。在一些实施例中，控制器或其他数据处理器被具体地编程、配置和/或构建成执行这些计算机可执行指令中的一个或多个。此外，本技术的一些方面可以采取存储或分布在计算机可读介质上的数据(例如非瞬态数据)的形式，包括磁性或光学可读和/或可移动计算机磁盘以及在网络上电子分布的媒体。因此，本技术的特定方面的数据结构和数据传输被包含在本技术的范围内。本技术还包含对计算机可读介质进行编程以进行特定步骤的方法以及执行这些步骤的方法。
而且，除非词语“或”明确限于在参考两个或更多个项目的列表的情况下仅指代单一项目而排除其他项目，则在这样的列表中使用“或”将被解释为包括(a)所述列表中的任何单个项目、(b)所述列表中的所有项目或(c)所述列表中的项目的任何组合。另外，在全文中术语“包括”用于表示至少包括一个或多个引用的特征，由此不排除任何更大数量的相同特征和/或另外类型的其他特征。还应当理解，为了说明的目的，在此已经描述了具体实施例，但是可以进行各种修改而不偏离本技术。另外，虽然已经在某些实施方案的上下文中说明了与那些实施方案相关联的优点，但是其他实施方案也可以展现出这类优点并且并非所有的实施方案都必需展现出这样优点才落入本技术的范围之内。因此，本披露和相关技术可以涵盖本文中未明确示出或描述的其他实施例。

Claims (22)

1.一种导管设备，包括：
细长管状轴，所述细长管状轴具有近侧部分和远侧部分，其中，所述细长管状轴包括-
聚合物材料；
第一热电偶组件，所述第一热电偶组件包覆在所述轴的所述聚合物材料周围和/或嵌在所述轴的所述聚合物材料内，其中，所述第一热电偶组件包括由不同金属组成的第一对线；
第二热电偶组件，所述第二热电偶组件包覆在所述轴的所述聚合物材料周围和/或嵌在所述轴的所述聚合物材料内，其中，所述第二热电偶组件包括由不同金属组成的第二对线，并且其中，所述第二对线沿着所述细长轴在所述近侧部分与所述远侧部分之间与所述第一对线物理隔离且电气隔离；
第一电极，所述第一电极位于所述细长轴的所述远侧部分处并电联接至所述第一热电偶组件；
第二电极，所述第二电极位于所述细长轴的所述远侧部分处并电联接至所述第二热电偶组件，
其中，所述轴的所述远侧部分与所述第一电极和第二电极一起限定治疗组件，所述治疗组件被适配为位于病人血管内的目标位置处，
其中，所述细长轴与所述治疗组件一起穿过其中限定被构造成可滑动地接纳医用导丝的导丝腔，
其中，所述导丝相对于所述治疗组件的轴向运动使所述治疗组件在(a)低剖面输送构型与(b)具有螺旋形状的展开构型之间变换。
2.如权利要求1所述的导管设备，进一步包括：
第三热电偶组件，所述第三热电偶组件螺旋状地包覆在所述轴的所述聚合物材料周围和/或嵌在所述轴的所述聚合物材料内，其中，所述第三热电偶组件包括第三对线；
第四热电偶组件，所述第四热电偶组件螺旋状地包覆在所述轴的所述聚合物材料周围和/或嵌在所述轴的所述聚合物材料内，其中，所述第四热电偶组件包括第四对线；
第三电极，所述第三电极位于所述细长轴的所述远侧部分处并电联接至所述第三热电偶组件；以及
第四电极，所述第四电极位于所述细长轴的所述远侧部分处并电联接至所述第四热电偶组件，
其中，所述第一对线、第二对线、第三对线和第四对线都沿着所述细长轴在所述近侧部分与所述远侧部分之间彼此物理隔离且电气隔离。
3.如权利要求2所述的导管设备，其中，所述第一电极、第二电极、第三电极和第四电极包括金带电极。
4.如权利要求2所述的导管设备，其中，各个电极沿着所述细长轴彼此间隔开7.5mm。
5.如权利要求1所述的导管设备，进一步包括手柄，所述手柄经由卡扣配合安排而联接至所述细长轴的所述近侧部分。
6.如权利要求5所述的导管设备，其中，所述手柄的近侧部分包括安排在其上并与所述第一热电偶组件和第二热电偶组件的相应的各个线电接触的四个触点，并且其中，所述触点被定位成当所述轴的所述近侧部分与所述手柄以卡扣配合安排来联接时与由所述手柄携带的相应的多个销配对。
7.如权利要求6所述的导管设备，其中，所述触点是金触点。
8.如权利要求1所述的导管设备，进一步包括快速交换端口，所述快速交换端口沿着所述轴位于所述轴的所述近侧部分与所述远侧部分之间并与所述导丝腔连通，其中，所述轴的在所述快速交换端口与所述轴的所述近侧部分之间的部分是实心的。
9.如权利要求1所述的导管设备，其中：
在所述快速交换端口与所述轴的所述远侧部分之间，所述轴具有第一外直径；以及
在所述快速交换端口与所述轴的所述近侧部分之间，所述轴具有小于第一外直径的第二外直径。
10.如权利要求1所述的导管设备，其中，所述细长轴进一步包括与所述第一热电偶组件和第二热电偶组件的线穿插散布的单丝。
11.如权利要求1所述的导管设备，其中，所述第一热电偶组件和/或第二热电偶组件在所述轴的所述近侧部分处具有第一节距，并且在所述轴的所述远侧部分处具有第二节距，其中，所述第一节距小于所述第二节距。
12.如权利要求1所述的导管设备，其中，轴进一步包括包覆在所述轴周围的编织元件。
13.如权利要求12所述的导管设备，其中，所述编织元件与所述第一热电偶组件和/或第二热电偶组件交织。
14.一种神经调节导管，包括：
细长的聚合物轴，所述聚合物轴包括在其周围安排的多个热电偶丝；以及
多个神经调节元件，所述神经调节元件在所述聚合物轴的远侧部分处可操作地联接至所述聚合物轴，其中，各个神经调节元件电联接至相应的热电偶丝对，
其中-
每个热电偶丝沿着围绕所述聚合物轴的纵轴延伸的螺旋状路径分布，并且其中，沿着所述聚合物轴延伸的热电偶丝大体上彼此平行地安排，以及
所述聚合物轴的至少一部分包括穿过其中的内腔，其大小和形状被设定成可滑动地接纳医用导丝。
15.如权利要求14所述的神经调节导管，其中，所述聚合物轴包括在其周围安排的四对热电偶丝，并且其中，所述多个神经调节元件包括电联接至相应的热电偶丝对的四个金电极。
16.如权利要求14所述的神经调节导管，其中，所述聚合物轴包括沿着所述轴的第一区域和第二区域，并且其中，所述螺旋状路径包括贯穿所述第一区域的第一节距以及贯穿所述第二区域的与所述第一节距不同的第二节距。
17.如权利要求14所述的神经调节导管，其中，所述聚合物轴的所述远侧部分能够在低剖面输送状态与具有大体上螺旋状/螺旋形构造的扩张的展开状态之间变换。
18.一种制造医用装置的方法，所述方法包括：
将第一热电偶组件和第二热电偶组件定位在中心心轴的周围，其中，所述第一热电偶组件包括第一对线，并且所述第二热电偶组件包括第二对线；
沿着所述心轴编织所述第一热电偶组件的第一线以及所述第二热电偶组件的第二线，其中，第一线和第二线彼此间隔开并以螺旋样式沿着所述心轴安排；
将聚合物材料放置在经编织的第一线和第二线上，以在所述心轴周围形成细长管状轴；
选择性地移除所述细长轴的远侧区域处的所述聚合物材料的多个部分，以接近所述第一热电偶组件的所述第一线和所述第二热电偶组件的所述第二线；
将第一电极电联接至所述第一热电偶组件的所述第一线的暴露部分；
将第二电极电联接至所述第二热电偶组件的所述第二线的暴露部分；以及
从至少所述细长轴的所述远侧区域中移除所述心轴。
19.如权利要求18所述的方法，进一步包括：在从至少所述远侧区域中移除所述心轴之后，将所述细长轴的所述远侧区域以螺旋构造定位在心轴的周围，并且其中，所述方法进一步包括将所述远侧区域热定形成螺旋形状。
20.如权利要求18所述的方法，其中：
将第一电极电联接至所述第一线的暴露部分包括：将所述第一电极激光焊接至各个第一线；以及
将第二电极电联接至所述第二线的暴露部分包括：将所述第二电极激光焊接至各个第二线。
21.如权利要求18所述的方法，其中，所述细长轴的所述远侧区域包括穿过其中的导丝腔，并且其中，所述方法进一步包括形成沿着所述细长轴并与所述导丝腔连通的快速交换接入端口，其中，所述快速交换接入端口和所述导丝腔的大小和形状被设定成可滑动地接纳医用导丝。
22.如权利要求18所述的方法，其中，从至少所述细长轴的所述远侧区域中移除所述心轴包括：只从所述轴的在所述快速交换接入端口远侧的部分中移除所述心轴，使得所述轴的在所述快速交换接入端口近侧的部分穿过其中是实心的。
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EP4371512A2 (en) 2024-05-22
CN106232043B (zh) 2019-07-23
US20150305807A1 (en) 2015-10-29
EP3134018B1 (en) 2024-05-29
WO2015164280A1 (en) 2015-10-29
US20200360083A1 (en) 2020-11-19
US11464563B2 (en) 2022-10-11
EP4371512A3 (en) 2024-08-14
EP3134018A1 (en) 2017-03-01
JP2017513600A (ja) 2017-06-01
US20230010636A1 (en) 2023-01-12

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