CN103118619A - 用于肾神经消融的多个柔性线丝上的rf电极 - Google Patents
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Abstract
一种导管包括具有远端的柔性轴,其长度被设置成用于在病人肾动脉内的展开。许多细长弹性构件被沿着轴的远端的纵向长度安装,并且能够在限定于纵向间隔的接合位置之间的区域处从轴径向地延伸。一个或多个电极在径向可延伸区域处被安装在弹性构件的每一个上。许多导体被电耦接到电极并沿着导管的轴延伸。细长弹性构件当被包围在外护套的腔内时是可收缩的,并且当导管和弹性构件轴向地延伸超过护套的远侧尖端时能够在限定于纵向间隔的接合位置之间的区域处从轴径向地向外延伸。RF能量被输送至电极以便消融血管周围肾神经。
Description
发明内容
本公开的实施例一般地涉及用于从脉管(vessel)内消融人体的目标组织的设备和方法。实施例涉及高频AC(例如,射频(RF))消融导管、系统以及方法,其采用多个柔性线丝上的电极以用于电极在目标脉管内的增强并置,特别是针对沿着脉管的内壁的不规则性而言。本公开的各种实施例涉及用于消融血管周围肾神经(诸如用于高血压治疗)的设备和方法。
根据各种实施例,一种用于输送消融治疗的设备包括护套,护套具有腔和相对于经皮进入位置足以进入病人体内的目标脉管的一段轴。导管包括具有近端、远端以及长度的柔性轴,轴的长度足以相对于经皮进入位置进入目标脉管。该轴的尺寸被设置成用于在护套的腔中移位并且可延伸超过护套的远侧尖端。
所述设备包括多个细长弹性构件,每个细长弹性构件沿着轴的远端的纵向长度安装。弹性构件在许多纵向间隔的位置接合轴,并且能够在限定于纵向间隔的接合位置之间的区域处从轴径向地延伸。一个或多个电极在径向可延伸区域处被安装在弹性构件的每一个上。许多导体被电耦接到电极并沿着导管的轴延伸。细长弹性构件当被包围在护套的腔内时是可皱缩的,并且当导管和弹性构件轴向地延伸超过护套的远侧尖端时能够在限定于纵向间隔的接合位置之间的区域处从轴径向地向外延伸。
根据某些实施例,一种设备包括护套,护套具有腔和足以相对于经皮进入位置进入病人的肾动脉的长度。导管包括具有近端、远端以及长度的柔性轴,轴的长度足以相对于经皮进入位置进入病人的肾动脉。轴的尺寸设置成用于在护套的腔内移位并且可延伸超过护套的远侧尖端。
所述设备包括许多细长弹性构件,每个细长弹性构件沿着轴的远端的纵向长度安装。弹性构件在许多纵向间隔的位置接合轴,并且能够在限定于纵向间隔的接合位置之间的区域处从轴径向地延伸。一个或多个电极在径向可延伸区域处被安装在弹性构件的每一个上。许多导体被电耦接到电极并沿着导管的轴延伸。细长弹性构件当被包围在护套的腔内时是可皱缩的,并且当导管和弹性构件轴向地延伸超过护套的远侧尖端时能够在限定于纵向间隔的接合位置之间的区域处从轴径向地向外延伸。
鉴于以下详细讨论和附图,可以理解这些以及其他特征。
附图说明
图1是右肾和包括从腹主动脉横向地分支的肾动脉的肾脉管系统的图示;
图2A和2B示出肾动脉的交感神经支配;
图3A示出肾动脉的壁的各种组织层;
图3B和3C示出肾神经的一部分;
图4A示出根据各种实施例的用于消融人体脉管的目标组织的设备;
图4B示出根据各种实施例的用于消融人体脉管的目标组织的设备;
图4C示出了当被包围在护套或目标脉管的腔内时的处于皱缩构造的消融治疗元件的细长弹性构件;
图5和6示出根据本公开的低断面实施例的支撑线丝段装置和缩回机构的导管轴的远端;
图7和8示出根据各种实施例的导管,其包括由线丝段装置支撑且具有组织移位特征的多个电极;
图9和10示出根据各种实施例的促进线丝段装置的可控扩张和缩回的布置;
图11示出根据各种实施例的具有绝缘套管或涂层的弹性构件;
图12-15示出消融治疗元件的各种实施例,其包括相对于彼此以结构协作构造安装的多个弹性构件;以及
图16示出根据各种实施例的代表性RF肾治疗设备。
具体实施方式
本公开的实施例涉及用于从脉管内消融目标组织的设备和方法。本公开的实施例涉及用于从肾动脉内消融血管周围肾神经以便治疗高血压的设备和方法。本公开的实施例包括支撑多个电极以便输送肾神经消融的线丝段结构。
在血管周围肾神经消融期间获得与动脉壁的良好接触是困难的。如果接触是可变的,则组织温度未受到很好的控制,并且可能不会在目标组织中实现消融温度,同时在诸如动脉壁各部分的其他区域中的温度可能偏离到足以引起不想要的动脉组织损伤。针对理想的解剖结构,可以更容易地实现良好的脉管壁贴合,但是尤其是在扭曲或患病肾动脉的情况下,可能存在非常差的接触而不能有效地且可预测地从消融设备向组织传输电流。可能期望多个离散区域处的受控消融以减少动脉损伤,而不要求多个重复定位和消融循环。存在对用于神经消融及其他治疗的改进的脉管壁接触和多点消融的持续需要。
本公开的实施例涉及用于血管周围肾神经的多点RF消融以用于高血压治疗的设备和方法。根据各种实施例,血管内导管设备在远端附近具有多个线丝段,其在低断面引入构造与大直径展开构造之间移动。一个或多个RF电极被安装在单独的线丝段上。线丝段可包括可扩张曲线、环路、网、篮或其他结构以将RF电极放置在单独的位置上。
当线丝段结构展开时,其弯曲以适应变化的脉管解剖结构。线丝段展开可以如在固定篮构造中被耦接,或者是独立的,使得每个线丝段扩张解剖结构要求的那么多。线丝段的展开将RF电极置于与脉管壁的良好接触。
可以使导管设备前进并在肾动脉中展开以消融肾神经。通过经由沿着导管的绝缘导体从外部能量源进行激励来激活某些RF电极或组合,提供多个离散的RF消融区域。展开可以利用自动扩张弹力、推/拉控制结构、外部保持和重新捕捉护套以及其他联动装置和结构。可以使用外护套在放置和收回期间在导管的远端处保护和约束线丝段。
根据各种实施例,血管内导管设备在远端附近具有多个线丝段,其在低断面引入构造与大直径展开构造之间移动。一个或多个RF电极被安装在单独的线丝段上。线丝段可包括可扩张曲线、环路、网、篮或其他结构以将RF电极放置在单独的位置上。当线丝段结构展开时,其弯曲以适应变化的脉管解剖结构。
在一个构造中,线丝段独立于其他线丝,使得每个线丝段扩张解剖结构要求的那么多。线丝段可以被绝缘并充当外部RF控制单元与电极之间的电导体。通过经由沿着导管的绝缘导体从外部能量源进行激励来激活某些RF电极或组合,提供多个离散的RF消融区域。展开可以利用自动扩张弹力、推/拉控制结构、外部保持和重新捕捉护套以及其他联动装置和结构。
线丝段的展开将RF电极置于与脉管壁的良好接触。可以使用外护套在放置和收回期间在导管的远端处保护和约束线丝段。可以使导管设备前进并在肾动脉中展开以消融肾神经。在将导管的远端定位于肾动脉内之后,可以使护套缩回以允许线丝段展开和扩张。
在其他实施例中,线丝段可以如在固定篮构造中被耦接,很像标测导管(mapping catheter)。可以同时地激励某些或所有电极,或者可以激励单独电极或电极的子集以消融血管周围神经的一个或多个区域。变化包括线丝段和电极的数目、周向位置和轴向位置。线丝段可以具有螺旋或其他弯曲。可以将线丝段构造为环路。
可以推动或拉动线丝的近端以帮助展开。可以将线丝段的远端附着于导管。可以提供腔段或滑动附着点以控制该线丝但允许展开移动。
可以用线丝段的推拉展开来将具有电极的多个线丝段结合到导管中。可以将电极成形为使内动脉壁的组织朝着外动脉壁移位,从而有效地缩短将电极和邻近于外动脉壁的神经支配目标组织分离的距离。根据各种实施例,电极包括组织移位尖端,其具有将内动脉壁强制地推入外动脉壁中(从而挤压中间的动脉壁组织)而不穿透内或外动脉壁的半径。在某些实施例中,可能期望允许电极尖端穿过内动脉壁,但是优选地不穿过外动脉壁。可以在前进和缩回期间使用外护套来覆盖线丝和电极。
可以在电极的位置处提供诸如热电偶的一个或多个温度传感器以测量电极的温度。在某些实施例中,温度传感器位于每个电极的位置处或附近,允许消融电极布置的单独电极位置处的精确温度测量。
本公开的各种实施例涉及用于治疗高血压的用于肾神经去除的设备和方法。高血压是血压升高的慢性医学疾病。持久性高血压是与多种负面医学疾病相关联的显著风险因素,包括心脏病发作、心力衰竭、动脉瘤以及中风。持久性高血压是慢性肾衰竭的主要原因。服务于肾的交感神经系统的亢进与高血压及其进展相关联。经由肾神经去除进行的肾中的神经去激活能够降低血压,并且可能是用于对常规药物没有反应的具有高血压的许多病人的可行治疗选择。
肾在许多人体过程中起作用,包括血液过滤、液体平衡的调节、血压控制、电解质平衡以及激素产生。肾的一个主要功能是从血液去除毒素、无机盐和水以形成尿。肾通过肾动脉接收心输出量的约20-25%,肾动脉从腹主动脉的左和右分支,在肾的凹面(即肾门)处进入每个肾。
血液通过肾动脉和输入小动脉流入肾,进入肾的过滤部分,即肾小球。肾小球由小球(即称为肾小囊的被充满体液的杯形囊围绕的毛细血管丛)组成。由于存在于毛细血管中的血压与肾小囊中的体液之间的压力梯度,血液中的溶解物通过小球的非常薄的毛细血管壁被过滤。由小动脉的收缩或扩张来控制压力梯度。在过滤发生之后,已过滤血液穿过输出小动脉和肾小管周围毛细血管,在小叶间静脉中汇合,并且最后通过肾静脉离开肾。
从血液过滤的颗粒和体液通过许多小管从肾小囊移动至集合管。尿在集合管中形成并随后通过输尿管和膀胱离开。小管被肾小管周围毛细血管(包含已过滤血液)围绕。随着滤液穿过小管并朝向集合管,营养素、水和电解液(诸如钠和氯化物)被再吸收到血液中。
肾是受肾丛神经支配的,肾丛主要源自于主动脉神经节。肾神经节由肾丛的神经在神经遵循肾动脉的路线并进入肾时形成。肾神经是自主神经系统的一部分,其包括交感和副交感组分。交感神经系统被称为提供人体“战斗或逃走”响应的系统,而副交感神经系统提供“休息与消化”响应。交感神经活动的刺激触发交感神经响应,其促使肾增加激素的产生,其增加血管收缩和体液潴留。此过程称为对于增加的肾交感神经活动的肾素-血管紧张素-醛甾酮-系统(RAAS)响应。
响应于血容量的减少,肾分泌肾素,这刺激了血管紧张素的产生。血管紧张素促使血管收缩,导致增加的血压,并且还刺激激素醛甾酮从肾上腺皮质的分泌。醛甾酮促使肾的小管增加钠和水的再吸收,这增加体内的液体量和血压。
充血性心力衰竭(CHF)是与肾功能有联系的疾病。当心脏不能遍及全身有效地泵送血液时发生CHF。当血流下降时,肾功能由于肾小球内的血液的不足灌注而下降。到肾的减少血流触发交感神经系统活动的增加(即,RAAS变得过于活动),这促使肾分泌增加体液潴留和血管收缩的激素。体液潴留和血管收缩又增加循环系统的外围阻力,对心脏施加甚至更大的负荷,这进一步减少血流。如果心脏和肾功能的退化继续,最后,身体垮掉,并且发生心力衰竭代偿失调的情况,常常导致病人的住院治疗。
图1是右肾10和包括从腹主动脉20横向地分支的肾动脉12的肾脉管系统的图示。在图1中,出于说明的简化目的,仅示出了右肾10,但是在本文中将对左肾和右肾两者以及相关联的肾脉管系统和神经系统结构进行参考,其在本公开的实施例的背景下全部被设想到。肾动脉12被有目的地示出为不成比例地大于右肾10和腹主动脉20,以便促进本公开的各种特征和实施例的讨论。
左肾和右肾被从左肾动脉和右肾动脉供应血液,左肾动脉和右肾动脉从腹主动脉20的各自的左横向表面和右横向表面分支。左肾动脉和右肾动脉中的每一个被指引跨越橫膈脚,从而与腹主动脉20几乎形成直角。左肾动脉和右肾动脉大体上从腹主动脉20延伸至接近于肾的肾门17的各自肾窦,并分支到分段动脉且随后分成肾10内的小叶间动脉。小叶间动脉向外辐射,穿透肾小囊并延伸通过肾锥体之间的肾柱。通常,肾接收总心输出量的约20%,其对于正常人而言代表每分钟通过肾的约1200 mL的血流。
肾的主要功能是通过控制尿的产生和浓度来保持用于人体的水和电介质平衡。在产生尿时,肾分泌诸如尿素和铵的废物。肾还控制葡萄糖和氨基酸的再吸收,并且在包括维他命D、肾素和促红细胞生成素的激素的产生中是重要的。
肾的重要辅助功能是控制人体的新陈代谢的动态平衡。控制止血功能包括调节电解液、酸碱平衡和血压。例如,肾负责通过例如调整在尿中损失的水容量并释放促红细胞生成素和肾素来调节血容量和压力。肾还通过控制在尿中损失的量和骨化三醇的合成来调节血浆离子浓度(例如纳、钾、氯离子、以及钙离子水平)。由肾控制的其他止血功能包括通过控制尿中的氢和重碳酸盐离子的损失来使血液pH稳定,通过防止有价值营养素的分泌来将其保留,以及帮助肝排毒。
在图1中还示出了右肾上腺11,一般称为右肾上腺。肾上腺11是停靠在肾10的顶部上的星形内分泌腺。肾上腺(左和右)的主要功能是通过皮质甾和儿茶酚胺(分别包括皮质醇和肾上腺素)的合成来调节人体的压力响应。围绕肾10、肾上腺11、肾脉管12以及相邻周围脂肪的是肾筋膜,例如Gerota筋膜(未示出),其是从腹膜外结缔组织衍生出的筋膜袋。
人体的自主神经系统控制血管、消化系统、心脏和腺中的平滑肌的不自主动作。自主神经系统被划分成交感神经系统和副交感神经系统。一般而言,副交感神经系统通过降低心率、降低血压和刺激消化来使身体准备好休息。交感神经系统通过增加心率、增加血压和增加新陈代谢来实行人体的战斗或逃跑响应。
在自主神经系统中,源自于中枢神经系统并延伸至各种神经节的纤维称为节前纤维,而从神经节延伸至效应器官的那些称为节后纤维。通过从肾上腺11释放肾上腺素和较小程度的降肾上腺素来实现交感神经系统的激活。这种肾上腺素的释放是由从节前交感神经释放的神经递质乙酰胆碱触发的。
肾和输尿管(未示出)是受肾神经14神经支配的。图1和2A-2B示出肾脉管系统的交感神经支配,主要是肾动脉12的神经支配。肾脉管系统的交感神经支配的主要功能包括肾血流量和血压的调节、肾素释放的刺激以及水和钠离子再吸收的直接刺激。
对肾脉管系统进行神经支配的大部分神经是从肠系膜上神经节26出现的交感节后纤维。肾神经14大体上轴向地沿着肾动脉12延伸,在肾门17处进入肾10,跟随肾10内的肾动脉12的分支,并延伸至单独的肾元。诸如肾神经节24、肠系膜上神经节26、左右主动脉神经节22和腹腔神经节28的其他肾神经节也对肾脉管系统进行神经支配。腹腔神经节28被较大胸内脏神经(较大TSN)连结。主动脉神经节26被较小胸内脏神经(较小TSN)连结并对肾丛的较大部分进行神经支配。
到肾10的交感信号是经由主要在脊柱段T10-T12和LI处发起的受神经支配的肾脉管系统传送的。副交感信号主要在脊柱段S2-S4处且从低位脑的延髓发起。交感神经往来穿过交感干神经节,在那里,某些可以形成突触,而其他的在主动脉神经节22(经由较小胸内脏神经,即较小TSN)和肾神经节24(经由最小胸内脏神经,即最小TSN)处形成突触。突触后交感信号然后沿着肾动脉12的神经14行进至肾10。突出前副交感信号行进至肾10附近的位置,然后它们在肾10上或附近形成突触。
特别地参考图2A,如大多数动脉和小动脉的情况一样,肾动脉12内衬有控制肾动脉腔13的直径的平滑肌34。平滑肌一般地是在大和小动脉和静脉的中间层以及各种器官内找到的非自主平滑肌。肾的血管小球例如包含称为系膜细胞的平滑肌状细胞。平滑肌在结构、功能、兴奋-收缩耦接、以及收缩机制方面根本上不同于骨骼肌和心肌。
可以刺激平滑肌细胞以通过自主神经系统收缩或松弛,但是还可以应来自相邻细胞的刺激并响应于激素和血液产生的电解液和药剂(例如,血管扩张剂或血管收缩剂)而起反应。例如,肾10的肾小球旁器的输入小动脉内的专用平滑肌细胞产生激活血管紧张素II系统的肾素。
肾神经14对肾动脉壁15的平滑肌34进行神经支配,并沿着肾动脉壁15以大体轴向或纵向方式纵长地延伸。平滑肌34周向地围绕肾动脉,并且沿着大体上横穿肾神经14的纵向取向的方向纵长地延伸,如图2B所示。
肾动脉12的平滑肌34处于自主神经系统的非自主控制下。交感活动的增加例如趋向于使平滑肌34收缩,这减小肾动脉腔13的直径并减少血液灌流。交感活动的减少趋向于促使平滑肌34松弛,导致脉管扩张和肾动脉腔直径和血液灌流的增加。相反,增加的副交感活动趋向于使平滑肌34松弛,而减少的副交感活动趋向于引起平滑肌收缩。
图3A示出了通过肾动脉的纵向横截面的一段,并且示出肾动脉12的壁15的各种组织层。肾动脉12的最内层是内皮30,其为内膜32的最内层并且由内弹性膜支撑。内皮30是接触流过脉管腔13的血液的单层细胞。内皮细胞通常是多边形的、椭圆形的或纺锭形的,并且具有非常可分辨的圆形或椭圆形核。内皮30的细胞与多血管功能有关,包括经由血管收缩和血管舒张的血压控制、血液凝固,并且充当腔13内的内含物与周围组织之间的阻挡层,诸如将内膜32与中间层34分离的内膜32的膜、以及外膜36。内膜32的膜或浸渍是高度弹性且一般具有纵向褶皱状图案的细微、透明、无色结构。
邻近于内膜32的是中间层33,其是肾动脉12的中间层。该中间层由平滑肌34和弹性组织构成。通过其色彩及通过其纤维的横向布置,可以很容易地识别中间层33。更特别地,中间层33主要由以薄板状方式或薄片布置并圆形地设置在动脉壁15周围的成束的平滑肌纤维34组成。肾动脉壁15的最外层是外膜36,其由结缔组织组成。外膜36包括在伤口愈合中起到重要作用的成纤维细胞38。
血管周围区域37被示出邻近于肾动脉壁15的外膜36并在其外围。肾神经14被示出接近于外膜36且穿过血管周围区域37的一部分。肾神经14被示出沿着肾动脉12的外壁15基本上纵向地延伸。肾神经14的主干一般存在于肾动脉12的外膜36中或上,常常穿过血管周围区域37,某些分支行进到中间层33中而使肾动脉平滑肌34无力。
可以将本公开的实施例实现为向受神经支配的肾脉管系统提供不同程度的去神经治疗。例如,本公开的实施例可以提供由使用本公开的治疗设备输送的去神经治疗是吸纳的肾神经脉冲传输中断的程度和相对持久性的控制。可以修整肾神经损伤的程序和相对持久性以实现期望的交感神经活动的减少(包括部分和完整块),并实现期望程度的持久性(包括暂时性或不可逆的损伤)。
返回图3B和3C,图3B和3C中所示的肾神经14的一部分包括神经纤维14b的束14a,每个包括轴突或树突,其在位于神经节中或脊髓上或脑中的细胞体或神经元上起源或终止。神经14的支撑组织结构14c包括神经内膜(围绕神经轴突纤维)、神经束膜(围绕纤维群以形成簇)以及神经外膜(将簇束缚于神经中),其用于分离和支撑神经纤维14b和束14a。特别地,特别地,也称为神经内膜管或小管的神经内膜是一层纤弱的结缔组织,其围绕簇内的神经纤维14b的髓鞘。
神经的主要组成部分包括作为包括核子的神经元的中心部分的体细胞、称为树突的细胞扩展部分以及作为载送神经信号的电缆状突出体的轴突。轴突终端包含突触,其是其中释放神经递质化学品以便与目标组织通信的专用结构。周围神经系统的许多神经元的轴突被覆盖在髓鞘质中,其由称为神经膜细胞的一种胶质细胞形成。髓鞘神经膜细胞缠绕在轴突周围,使得轴膜在称为郎飞结的规则间隔节点处相对未被覆盖。轴突的髓鞘化使得能够实现称为突变的电脉冲传播的特别快速模式。
在某些实施例中,可以将本公开的治疗设备实施为输送去神经治疗,其对肾神经纤维14b造成瞬时和可逆损伤。在其他实施例中,可以将本公开的治疗设备实施为输送去神经治疗,其对神神经纤维14b造成更严重损伤,其在治疗以及时的方式终止的情况下可以是可逆的。在优选实施例中,可以将本公开的治疗设备实施为输送去神经治疗,其对肾神经纤维14b造成严重且不可逆的损伤,导致肾交感神经活动的永久停止。例如,可以将治疗设备实施为输送去神经治疗,其使神经纤维形态中断至足以在物理上分离神经纤维14b的神经内膜管的程度,这能够防止再生和重新神经支配过程。
举例来说,并且根据在本领域中已知的Seddon分类,可以将本公开的治疗设备实施为通过按照机能性麻痹对肾神经纤维14b给予破坏来中断神经脉冲沿着肾神经纤维14b的传导。机能性麻痹描述了不存在神经纤维14b或其鞘的中断的神经损伤。在这种情况下,存在神经脉冲沿神经纤维的传导的中断,在没有实际再生的情况下在几小时至几个月内发生恢复,因为未发生沃勒变性。沃勒变性指的是与神经元的细胞核分离的轴突的一部分变性的过程。此过程也称为顺行性变性。机能性麻痹是最轻度的神经损伤,可以通过使用根据本公开的实施例的治疗设备来将其赋予到肾神经纤维14b。
可以将治疗设备实施为通过按照轴突断伤对肾神经纤维给予损伤来中断神经脉冲沿着肾神经纤维的传导。轴突断伤涉及神经纤维的轴突的相对连续性的损失及其髓鞘质的覆盖,但保留了神经纤维的结缔组织框架。在这种情况下,保留了神经纤维14b的包封支撑组织14c。由于失去了轴突连续性,所以发生沃勒变性。从轴突断伤的恢复仅通过轴突的再生而发生,该再生是要求约几个星期或几个月的时间的过程。在电学上,神经纤维14b显示出快速且完全的变性。只要神经内管是完好无损的,再生和重新神经支配就可以发生。
可以将治疗设备实施为通过按照神经断伤对肾神经纤维给予损伤来中断神经脉冲沿着肾神经纤维14b的传导。根据Seddon分类的神经断伤是方案中最严重的神经损伤。在此类损伤中,神经纤维14b和神经鞘两者被中断。虽然可以发生部分恢复,但完全恢复是不可能的。神经断伤涉及轴突和包封结缔组织14c的连续性的损失,在肾神经纤维14b的情况下,导致自主机能的完全丧失。如果神经纤维14b已被完全分开,则轴突再生促使在近侧残端中形成神经瘤。
通过参考如在本领域中已知的Sunderland系统,可以找到神经断伤神经损伤的更多层次的分类。Sunderland系统定义了五个程度的神经损伤,其中的前两个与Seddon分类的机能性麻痹和轴突断伤紧密地相对应。后三个Sunderland系统分类描述不同水平的神经断伤神经损伤。
Sunderland系统中的第一和第二程度的神经损伤分别类似于Seddon的机能性麻痹和轴突断伤。根据Sunderland系统,第三程度神经损伤涉及神经内膜的中断,神经外膜和神经束膜保持完好无损。根据束内纤维化,恢复可以在从很差至完全的范围内。第四程度神经损伤涉及所有神经和支撑元件的中断,神经外膜保持完好无损。神经通常扩大。第五程度的神经损伤涉及具有连续性损失的神经纤维14b的完全横断。
现在转到图4A,示出根据各种实施例的用于消融人体脉管的目标组织的设备。根据某些实施例,并且如图4A中所示,该设备包括护套119,护套119具有腔和相对于经皮进入位置足以进入病人的目标脉管(诸如病人的肾动脉)的长度。该设备还包括导管100,其包括具有近端、远端和长度的柔性轴104。轴104的长度相对于经皮进入位置足以进入目标脉管,诸如病人的肾动脉12。导管100的轴104的尺寸被设置成用于在护套119的腔内的移位,并且可延伸超过护套119的远侧尖端。
在导管的轴104的远端处提供了多个细长弹性构件131。在图4A中所示的代表性实施例中,在导管的轴104的远端处提供四个细长弹性构件131a-131d。细长弹性构件131a-131d中的每一个沿着轴104的远端的纵向长度安装,并且在两个或更多个纵向间隔的位置处接合轴104。细长弹性构件131a-131d被安装在轴104上,使得每个能够在限定于纵向间隔接合位置之间的区域处从轴104径向地延伸。细长弹性构件131a-131d由在弹性构件131a-131d中产生弹力的材料形成,该弹力在导管100和弹性构件131a-131d轴向地延伸超过轴104的远侧尖端时足以引起弹性构件131a-131d的自动扩张。例如,弹性构件131a-131d可以由柔性导电材料形成,其促进弹性构件131a-131d的弯曲以适应肾动脉解剖结构的变化。
一个或多个电极120在径向可延伸区域处被安装在每个弹性构件131a-131d上。在图4A中所示的代表性实施例中,示出了在轴104的纵向间隔接合位置之间的顶点位置处安装在四个弹性构件131a-131d中的每一个上的一个电极120-120d。导体装置电耦接到安装在每个弹性构件131a-131d上的一个或多个电极120并沿着轴104延伸至导管100的近端。
在某些实施例中,每个弹性构件131a-131d限定导体,其沿着轴104延伸并提供与导管100的近端处的电极120a-120d的电连接。可以用沿着轴104的长度延伸的区域上的绝缘套管或涂层来覆盖弹性构件131a-131。在其他实施例中,可以将轴104的单独腔的尺寸设置为接收弹性构件131a-131d中的一个,其可以包括弹性构件构造(其不包括绝缘套管或涂层)中的绝缘材料的内壁。在其他实施例中,可以将每个弹性构件131a-131d耦接到导管100的远端附近的各自电导体,并且该电导体可以沿着轴延伸并且可在导管100的近端处接近。
细长弹性构件131a-131d优选地由具有形状记忆的弹性导电合金构成。如在图4C中最好地看到的,细长弹性构件131a-131d当被包围在护套119的腔内或目标脉管(诸如病人肾动脉12)的腔内时是可皱缩的。当轴向地延伸超过护套119的远侧尖端时,弹性构件131a-131d在限定于纵向间隔的接合位置之间的区域处从轴104径向地向外扩张。安装在弹性构件131a-131d的顶点位置处或附近的电极120a-120d通过向外扩张的弹性构件131a-131d而向外移动并形成与目标脉管的内壁的被迫接合。在展开构造中,多个弹性构件131a-131d提供电极120a-120d在目标脉管内的增强并置,特别是针对沿着脉管内壁的不规则性而言。
根据各种实施例,弹性构件131a-131d被绕着导管的轴104的周界布置,使得电极120a-120d位于目标脉管(诸如肾动脉)的壁的互异位置处。例如,弹性构件131a-131d被绕着导管的轴104的周界布置,使得电极120a-120d形成大体上螺旋形状,以在导管100和弹性构件131a-1313d轴向地延伸超过护套119的远侧尖端时促进肾动脉壁中的螺旋损害的形成。
在某些实施例中,弹性构件131a-131d被沿着轴104的远端的纵向长度在结构上相互独立地安装。优选地选择弹性构件131a-131d的形状记忆,使得弹性构件131a-131d在处于其扩张展开构造时保持间隔开的关系。在此类构造中,不需要用绝缘套管或涂层来覆盖弹性构件131a-131d,不过如果期望的话,可以包括此类套管或涂层。根据利用紧密间隔的弹性构件131a-131d的其他实施例,可能期望用绝缘套管或涂层来覆盖(一个或多个)电极120a-120d近侧和远侧的弹性构件131a-131d。图11示出具有绝缘套管或涂层137的弹性构件131,绝缘套管或涂层137覆盖在由弹性构件131支撑的电极120近侧和远侧的弹性构件131的一些部分。
根据各种实施例,多个弹性构件131被沿着轴104的远端的纵向长度相对于彼此以结构协作构造安装。在图12-15中示出了此类实施例的说明性示例。图12例如示出了由许多弹性构件131形成且具有篮或网构造的线丝段装置127。篮或网的每个弹性构件131具有大体上弓形的形状,其相对的端部在公共的远侧和近侧周向安装区域处接合轴104。
图12中的每个弹性构件131被示为支撑多个电极120(例如,6个电极120)。在某些实施例中,将由单独弹性构件131支撑的电极120串联连接。在其他实施例中,经由单独导体来连接由单独弹性构件131支撑的电极120中的全部或至少某些。在此类实施例中,由单独弹性构件131支撑的所有或至少某些电极120是单独可控的,允许篮或网装置127的电极120的选择性激活和去激活。
可以将线丝段装置127的弹性构件131布置成形成可扩张曲线或环。在图13-15中示出了其他线丝段装置构造127的说明性示例。可设想这些及其他线丝段装置127,其可以在线丝段和电极的数目、周向位置和轴向位置方面改变。
可以同时地激励线丝段装置127的某些或所有电极120,或者可以激励单独电极120或电极120的子集以消融血管周围神经的一个或多个区域。例如,电极120可以是可单独激励的,以产生肾动脉的多个离散消融区域。线丝段装置127的一个或多个弹性构件131的电极120的选择性激活和去激活有利地提供具有多种形状(例如,螺旋的、周向的、斑点)和尺寸(例如,诸如通过在产生损害时增加或减少被激活电极120的数目)的损害的形成。本公开的这些及其他实施例促进在目标脉管中的具有期望形状和尺寸(例如,目标脉管壁的完整的一圈)的损害的形成,而不必在消融程序期间将导管轴104重新定位。
图4B示出根据各种实施例的用于消融人体脉管的目标组织的设备。在图4B中所示的实施例中,导管100包括安装在导管的轴104的远端处的多个细长弹性构件131,并且类似于图4A中所示的导管实施例。每个细长弹性构件131a-131d被沿着轴104的远端的纵向长度安装,在两个或更多纵向间隔位置处接合轴104,并且当被包围在护套119的腔内时是可皱缩的。当轴向地延伸超过护套119的远侧尖端时,弹性构件131a-131d从轴104径向地向外扩张,促使安装在弹性构件131a-131d的顶点位置处或附近的电极120a-120d向外移动并形成与目标脉管的内壁的被迫接合。
图4B中所示的实施例包括在导管100的远端处的线丝段装置处提供的温度传感器123。如图4B中所示,细长弹性构件131a-131d中的每一个支撑在细长弹性构件131a-131d的电极120a-120d处或附近提供的温度传感器123a-123d,诸如热电偶。每个温度传感器123a-123d被耦接到各自的传感器线丝,其沿着导管100的轴104的长度延伸并且可在导管100的近端处接近。
传感器线丝可以是以理发店旋转圆筒(barber pole)方式缠绕在弹性构件131周围的柔软的被绝缘的线丝。在其他构造中,传感器线丝可以平行于弹性构件131a-131d行进并且被结合到弹性构件131a-131d。在其他实施例中,可以用电绝缘套管或涂层来覆盖弹性构件131a-131d,在这种情况下,传感器线丝不需要具有电绝缘套管或涂层。
图5和6分别示出根据各种实施例的导管100,其包括以展开和缩回构造被线丝段装置支撑的多个电极。图5和6示出根据本公开的低断面实施例的导管轴104的远端,导管轴104支撑线丝段装置和缩回机构。在图5中所示的实施例中,导管100包括线丝段装置,其包括纵向地和周向地相互间隔的四个细长弹性构件131a-131d。四个细长弹性构件131a-131d中的每一个支撑电极120a-120d。弹性构件131a-131d和电极120a-120d被布置成使得可以消融目标脉管的至少一个整圈,而不必在消融程序期间将导管100重新定位。
导管轴104包括腔,一对控制线丝133a、133b延伸通过该腔。控制线丝133a、133b可以位于轴104的公共腔中或位于单独的腔中。控制线丝133a、133b的远端被耦接到弹性构件131a-131d的近端,其经由穿过轴壁的小孔或裂缝进入控制线丝腔。可以将密封装置在线丝段装置近侧定位于控制线丝腔中,以防止血液在密封装置近侧进入轴104。
在各种实施例中,控制线丝133a、133b被耦接到弹性构件131a-131d以由临床医生来提供弹性构件131a-131d的推拉展开和缩回。在某些构造中,两个最远侧弹性构件131a和131b的远端被耦接到控制线丝133a,并且两个最近侧弹性构件131c和131d的远端被耦接到控制线丝133b。当弹性构件131a和131b处于缩回构造(参见图6)时推控制线丝133a,促使弹性构件131a和131b从轴104向外移动成展开构造(参见图5)。当弹性构件131a和131b处于展开构造时拉控制线丝133a,促使弹性构件131a和131b向内移动至轴104的控制线丝腔中(如图6的缩回构造中所示)。可以通过以与上文关于控制线丝133a所述的相同方式来操纵控制线丝133b来使弹性构件131c和131d移动成展开和缩回构造。
在其他实施例中,弹性构件131a-131d中的每一个被耦接到单个控制线丝133。在此构造中,沿远侧方向推控制线丝133促使弹性构件131a-131d移动至展开构造。沿近侧方向拉控制线丝133促使弹性构件131a-131d移动至缩回构造。在其他实施例中,可以将每个弹性构件131a-131d耦接到单独的控制线丝131。在此构造中,可以通过推和拉被耦接到单独弹性构件131a-131d的各自控制线丝131来使单独弹性构件131a-131d移动至展开和缩回构造。可以使用护套(未示出)在导管100前进到目标脉管和从目标脉管缩回期间覆盖线丝段装置131a-131d和电极120a-120d。
图7和8示出根据各种实施例的导管100,其包括由线丝段装置支撑且具有组织移位特征的多个电极。出于清楚解释的目的,仅示出了支撑单个电极的一个线丝段装置。图7中所示的电极包括从电极主体120伸出的组织移位尖端125。组织移位尖端125的长度被选择为限制组织移位尖端125进入目标脉管壁的移位深度。例如,并且如图8中所示,电极120的组织移位尖端125所具有的长度和半径允许组织移位尖端125强制地使肾动脉壁12的壁的组织移位至规定深度但至少不刺穿肾动脉12的外壁。用于图8所示应用的组织移位电极120和尖端125通常具有不长于约2.5mm的长度。
将图7和8中所示的电极120构造成包括组织移位尖端125通过挤压内和外动脉壁之间的动脉组织来有效地减小电极120与目标组织(诸如血管周围肾神经)之间的距离。减小电极120与目标组织之间的距离有利地减少对相邻非目标组织的热损伤的程度,并且可以减小消融血管周围肾神经所需的电流密度。
图9和10示出根据各种实施例的促进线丝段装置的可控扩张和缩回的布置。在图9中所示的实施例中,支撑电极120的细长弹性构件131具有固定地位于轴104的外壁处的远端143。优选地经由进入孔口141将弹性构件131的远端1434结合或以其他方式附接到轴104的内壁安装位置。在图9中,以扩张展开构造示出了弹性构件131,其中,电极120被支撑在相对于轴104的外壁的横向高度h1处。在各种实施例中,横向高度h1可以相对于轴104的外壁在约1mm与约4.5mm之间的范围。
弹性构件131的近端被示为能够响应于施加到弹性构件131的近端或施加到被耦接到弹性构件131的近端的其他细长构件的指向近侧和远侧的力而移位。可以使弹性构件131的近端移位通过行进长度l1,其足以将弹性构件131相对于轴104的外壁的扩张和皱缩限制在横向高度尺寸h1内。当处于其缩回构造时,弹性构件131被抵靠着轴的外壁挤压,并且沿着轴104的外壁基本放平,将横向高度h1减小到比电极120和弹性构件131的组合厚度(例如,约0.2mm的组合厚度)多一小点。
当抵靠着轴的外壁挤压弹性构件131时,诸如当使输送护套在弹性构件131上前进时,迫使弹性构件131的近端向近侧进入轴104中的腔中或沿着轴104。弹性构件131的近端到其腔中的前进允许弹性构件131抵靠着轴104的外壁采取低断面。当去除输送护套时,自动扩张的弹性构件131扩张而采取其预成形形状,促使弹性构件131的近端向远侧移动一些而至少部分地从其腔出来。
在某些构造中,在弹性构件131的近端上施加指向远侧的力以实现弹性构件131的完全扩张。在其他构造中,形成弹性构件131的材料的弹力通过使弹性构件131上的张力放松来引起弹性构件131到其展开构造的自动扩张。在各种构造中,可以在弹性构件131的近端上施加一定程度的指向远侧的力以加强弹性构件131到其展开构造的自动扩张。
根据某些实施例,控制线丝133被附接到弹性构件131的远端,并且可由临床医生在导管100的近端处致动,例如以先前关于图5和6所述的方式。在其他实施例中,不使用控制线丝133,并且上文所讨论的缩回和扩张机制响应于在使用期间向弹性构件131施加挤压力和从弹性构件131去除挤压力而自动地操作。
在图10中所示的实施例中,示出了可滑动止动装置,该可滑动止动装置包括一对止动件151a、151b,其捕捉弹性构件131的至少一段。止动构件153被安装到弹性构件131。弹性构件131沿远侧方向的轴向移位的范围受到止动构件153与远侧止动件151a之间的接触的限制。弹性构件131沿近侧方向的轴向移位的范围受到止动构件153与近侧止动件151b之间的接触的限制。因此,弹性构件131的轴向移位的范围受到在一对止动件151a、151b之间所限定的行进距离l2的限制。此行进距离l2限制弹性构件131的横向高度h2在扩张和皱缩构造之间所能改变的程度。优选地将行进距离l2选择为允许弹性构件131在展开构造中的完全扩张以及弹性构件131的完全压缩以实现低断面缩回构造。
当沿着近侧方向拉弹性构件131(或被耦接到弹性构件131的控制线丝)使得止动构件153接触近侧止动件151b时,支撑电极的弹性构件131朝着轴104的外表面皱缩直至实现完全低断面缩回或皱缩构造。当释放弹性构件131上的张力和/或施加指向远侧的力时,止动构件153朝着远侧止动件151a前进,允许弹性构件131随着止动构件153朝着远侧止动件151a前进而自动扩张至其预成形展开形状。当止动构件153接触远侧止动件151a时,弹性构件131实现其展开构造。应注意的是,可以在轴104的腔内,在轴104的壁内或在至少部分地沿着轴104的外壁延伸的侧腔中实施图9和10所示的布置。
图16示出了根本公开的各种实施例的代表性RF肾治疗设备300。图16中所示的设备300包括外部电极激活电路320,其包括功率控制电路322和定时控制电路324。外部电极激活电路320(其包括RF发生器)被耦接到温度测量电路328,并且可以被耦接到任选的阻抗传感器326。导管100包括轴104,其包括被构造成根据需要或要求接收多种部件的腔装置105,所述多种部件诸如导体、药剂、致动器元件、闭塞物、传感器或其他部件。
外部电极激活电路320的RF发生器可以包括返回垫电极330,其被构造成在肾附近舒适地接合病人的后背或身体的其他部分。由RF发生器产生的射频能量被设置在导管轴104的腔中的导体装置110耦合到导管101的远端处的治疗元件101。
利用图16所示设备的肾去神经治疗通常通过使用由位于肾动脉12内的治疗元件101的线丝段装置支撑的电极120和位于病人后背上的返回垫电极330来执行,RF发生器以单极模式操作。在此实施方式中,电极120a-120d例如被构造成以单极构造操作。在其他实施方式中,由治疗元件101的线丝段装置支撑的电极120可以构造成以双极构造操作,在这种情况下,不需要返回电极垫330。
射频能量根据预定激活序列(例如顺续的或同时的)流过电极120,引起离子搅动并因此引起肾动脉的相邻组织中的摩擦。
一般地,当肾动脉组织温度上升至高于约113℉(50℃)时,蛋白质被永久性地破坏(包括肾神经纤维的那些)。如果加热至超过约65℃,则胶原变性且阻止萎缩。如果加热至超过约65℃且高达100℃,则细胞壁破裂且油与水分离。高于约100℃,组织脱水。
根据某些实施例,电极激活电路320被构造成根据预定能量输送协议且响应于从温度测量电路328接收到的信号来控制电极120的激活和去激活。电极激活电路320控制被输送到电极120的射频能量,从而将电流密度保持在足以将目标组织加热到至少约55℃的温度的水平。
在某些实施例中,温度传感器位于治疗元件101处并提供肾动脉组织温度的连续监测,并且RF发生器的功率被自动地调整,从而实现并保持目标温度。可以使用阻抗传感器装置326来测量和监测RF去神经治疗期间的电阻抗,并且可以基于阻抗测量或阻抗和温度测量的组合来调节RF发生器320的功率和定时。被消融区域的尺寸在很大程度上由治疗元件101的线丝段装置所支撑的电极120的尺寸、数目和形状、所施加的功率、施加能量的持续时间决定。
可以将标记带314放置在治疗元件101的一个或多个部分上以使得能够在手术期间实现可视化。导管101的其他部分,诸如轴104的一个或多个部分(例如,在铰链机构356处)可以包括标记带314。标记带314可以是例如铂或其他不透辐射金属的实心带或分裂带。不透辐射材料被理解成是这样的材料,其能够在医疗程序期间在荧光检查屏或其他成像技术上产生相对明亮的图像。此相对明亮的图像帮助用户确定导管100的特定部分,例如导管101的尖端、治疗元件101以及铰链356。根据某些实施例,导管100的辫子和/或电极可以是不透辐射的。
一般地,在用于控制高血压的血管周围肾神经消融术的背景下描述了本文公开的各种实施例。然而应理解的是本公开的实施例可在其他背景下应用,例如从身体的其他脉管(包括其他动脉、静脉和脉管系统,例如心脏和泌尿脉管系统和脉管)和身体的其他组织(包括各种器官)内执行消融。
应理解的是即使在前述说明中已经阐述了各种实施例的许多特性以及各种实施例的结构和功能的细节,但此详细说明仅仅是说明性的,并且可以在由用来表达所附权利要求的措辞的广泛一般意义所指示的完整程度上在细节方面进行修改,尤其是在由各种实施例说明的部分的结构和布置方面。
Claims (15)
1.一种设备,包括:
护套,所述护套具有腔和足以相对于经皮进入位置进入病人体内的目标脉管的一段所述轴;
导管,所述导管包括具有近端、远端和长度的柔性轴,所述轴的长度足以相对于所述经皮进入位置进入所述目标脉管,所述轴的尺寸被设置成用于在所述护套的腔内的移位并且能够延伸超过所述护套的远侧尖端;
多个细长弹性构件,每个沿着所述轴的远端的纵向长度安装,所述弹性构件在多个纵向间隔的位置处接合所述轴并且能够在限定于纵向间隔的接合位置之间的区域处从所述轴径向地延伸;
一个或多个消融电极,所述一个或多个消融电极在径向可延伸区域处被安装在所述弹性构件的每一个上;以及
多个导体,所述多个导体被电耦接到所述一个或多个电极并沿着所述导管的轴延伸;
所述细长弹性构件当被包围在所述护套的腔内时是可皱缩的,并且当所述导管和所述弹性构件轴向地延伸超过所述护套的远侧尖端时能够在限定于纵向间隔的接合位置之间的区域处从所述轴径向地向外延伸。
2.根据权利要求1所述的设备,其中,所述弹性构件被绕着导管轴的周界布置以将电极定位在所述目标脉管的壁的互异位置处。
3.根据权利要求1所述的设备,其中,所述弹性构件的每一个被沿着所述轴的远端的纵向长度在结构上相互独立地安装。
4.根据权利要求1所述的设备,其中,所述弹性构件被沿着所述轴的远端的纵向长度相对于彼此以结构协作构造安装。
5.根据权利要求1所述的设备,其中,所述弹性构件被以篮或网构造布置。
6.根据权利要求1所述的设备,其中,所述弹性构件被布置成形成可扩张曲线或环。
7.根据权利要求1所述的设备,其中,所述弹性构件由柔性导电材料形成,其促进所述弹性构件的弯曲以适应目标脉管解剖结构的变化。
8.根据权利要求1所述的设备,其中,所述电极的每一个包括组织移位尖端。
9.根据权利要求8所述的设备,其中,所述组织移位尖端被构造成相对于所述目标脉管的外壁将所述目标脉管的内壁的组织强制地移位至规定深度,但是至少不刺穿所述目标脉管的外壁。
10.根据权利要求1所述的设备,其中,所述电极能够单独地激励以产生所述目标脉管的多个离散的消融区域。
11.根据权利要求1所述的设备,其中,所述弹性构件由在所述弹性构件中产生弹力的材料形成,在所述导管和所述弹性构件轴向地延伸超过所述护套的远侧尖端时,所述弹力足以引起所述弹性构件的自动扩张。
12.根据权利要求1所述的设备,其中,所述弹性构件由柔性材料形成,其促进所述弹性构件响应于被施加到所述弹性构件的扩张和收缩控制力而扩张和收缩。
13.根据权利要求1所述的设备,其中,所述弹性构件在所述电极之间的一部分被电绝缘体覆盖。
14.根据权利要求1所述的设备,其中,所述电极绕着所述导管轴的周界分布,以在所述导管和所述弹性构件轴向地延伸超过所述护套的远侧尖端时促进所述目标脉管的壁中的螺旋损害的形成。
15.根据前述权利要求中的任一项所述的设备,其中,所述目标脉管包括肾动脉,并且所述一个或多个消融电极被构造成当所述导管和所述弹性构件轴向地延伸超过所述护套的远侧尖端时消融邻近于所述肾动脉的血管周围肾神经组织。
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Also Published As
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US9408661B2 (en) | 2016-08-09 |
WO2012015722A1 (en) | 2012-02-02 |
US20160317222A1 (en) | 2016-11-03 |
CN103118619B (zh) | 2016-09-07 |
JP5953302B2 (ja) | 2016-07-20 |
CA2806728A1 (en) | 2012-02-02 |
US10531913B2 (en) | 2020-01-14 |
EP2598069A1 (en) | 2013-06-05 |
US20120029510A1 (en) | 2012-02-02 |
JP2013532552A (ja) | 2013-08-19 |
AU2011282933A1 (en) | 2013-02-21 |
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