CN103200893A - 用于肾去神经的自供电消融导管 - Google Patents
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Abstract
一种消融导管包括具有足以接近病人的肾动脉的长度的柔性轴。在轴的远端处提供了电极布置。把手单元包括被配置成用于手持式操纵且被耦合到导管的外壳。在外壳中提供了电池和高频AC发生器和超声波发生器中的一者或两者。电池充当用于发生器的唯一功率源。该发生器被配置成使用存储在电池中的能量来产生足以消融血管周围肾神经组织的能量。导管可以是一次性的,并且外壳是可再使用的。导管和外壳两者可以都是一次性。
Description
发明内容
本公开的设备、***和方法针对使用自供电消融导管来消融人体的目标组织。本公开的设备、***和方法针对使用由自供电消融导管输送的高频AC能量将对肾交感神经活动有所贡献的组织去神经。本公开的设备、***和方法针对使用由自供电消融导管输送的超声波能量将对肾交感神经活动有所贡献的组织去神经。
本公开的各种实施例针对消融装置和消融的方法,其包括或使用优选地被配置成用于手持式操纵的自供电消融导管。各种实施例针对消融装置和消融的方法,其包括或使用自供电消融导管,该自供电消融导管使用标准电池或多个标准电池作为用于消融能量源的惟一功率源,所述能量源诸如高频AC和/或超声波发生器。各种实施例针对消融装置和消融的方法,其包括或与外部病人监视器相组合地使用自供电消融导管。
根据各种实施例,一种装置包括导管和被耦合到导管的把手单元。该导管包括在长度方面足以接近病人身体的目标组织的柔性轴。在轴的远端处提供了电极布置。把手单元包括被配置成用于手持式操纵的外壳。在外壳中提供了电池。在外壳中提供了高频AC发生器和/或超声波发生器且其被耦合到电池。该电池优选地充当用于发生器的唯一功率源。发生器被配置成产生使用储存在电池中的能量来足以消融目标组织的能量。
根据一些实施例,一种装置包括具有在长度方面足以接近病人的肾动脉的柔性轴的导管。在轴的远端处提供了电极布置。该装置还包括把手单元,该把手单元包括用于手持式操纵且被耦合到导管的外壳。在外壳中提供了电池。在外壳中提供了高频AC发生器且被耦合到电池。该发生器被配置成使用储存在电池中的能量来产生足以消融血管周围肾神经组织的能量。该电池优选地充当用于发生器的唯一功率源。该发生器被配置成产生足以消融病人的肾动脉中的至少一个且优选地两个的血管周围肾神经组织的能量。
在其他实施例中,一种装置包括导管,该导管具有在长度方面足以接近病人的心脏的目标心脏组织的轴。在轴的远端处提供了电极布置。把手单元包括被配置成用于手持式操纵且被耦合到导管的外壳。在外壳中提供了电池。在外壳中提供了高频AC发生器且其被耦合到电池,其中,电池充当用于发生器的唯一功率源。发生器被配置成产生足以使用储存在电池中的能量来消融目标心脏组织的能量。
实施例针对各种方法,包括一种方法,该方法涉及使用在消融导管设备的手持式自供电把手单元中提供的电池,并由在把手单元内提供的发生器使用由电池供应的功率来产生高频AC能量,其中,该电池充当用于发生器的唯一功率源。该方法还包括向在邻近于病人的目标组织定位的导管的远端处提供的至少一个电极传送高频AC能量,并使用被传送至所述至少一个电极的高频AC能量来消融目标组织。
其他方法实施例涉及使用在消融导管设备的手持式自供电把手单元中提供的电池来供应功率,并由在把手单元内提供的发生器使用由电池供应的功率来产生高频AC能量,其中,所述电池充当用于发生器的唯一功率源。此类方法还涉及向在位于病人肾动脉内的导管的远端处提供的至少一个电极传送高频AC能量,并使用传送至所述至少一个电极的高频AC能量来消融血管周围肾神经组织。
其他方法实施例涉及使用在消融导管设备的手持式自供电把手单元中提供的电池来供应功率,并由在把手单元内提供的发生器使用由电池供应的功率来产生高频AC能量,其中,所述电池充当用于发生器的唯一功率源。这样的方法还涉及向在邻近于病人心脏的心脏组织定位的导管的远端处提供的至少一个电极传送高频AC能量,并使用被传送至所述至少一个电极的高频AC能量来消融心脏组织。
在一些实施例中,在外壳上提供了耦合器且其适合于将导管轴的近端连接到外壳和将该近端从外壳分离,使得可以分别地将一次性导管连接到可再用把手单元和从该把手单元分离。在其他实施例中,该外壳包括电池隔室,该电池隔室具有被配置成促进由用户进行的电池去除和替换的检查口(access
panel)。在其他实施例中,导管和把手单元被配置为一次性单元。
根据各种实施例,一种装置包括导管,该导管包括柔性轴和在轴的远端处提供的超声波换能器。把手单元包括被配置成用于手持式操纵且被耦合到导管的外壳。在外壳中分别提供了控制电路、电池和发生器。电池和控制电路被耦合到发生器。发生器被耦合到超声波换能器,并被配置成产生足以用于超声波换能器使用储存在电池中的能量消融人体的目标组织的能量。电池充当用于发生器的唯一功率源。
根据一些实施例,一种装置包括导管,该导管包括具有近端、远端、长度以及在近端与远端之间延伸的内腔布置的柔性轴。轴的长度足以相对于经皮接近位置而接近病人的肾动脉。在轴的远端处提供了超声波换能器。把手单元被配置成用于手持式操纵且被耦合到导管。在外壳中分别提供了控制电路、电池和发生器。发生器被耦合到超声波换能器且被耦合到电池和控制电路。该发生器被配置成产生足以用于超声波换能器使用储存在电池中的能量来消融血管周围肾神经组织,该电池充当用于发生器的唯一功率源。
根据各种实施例,一种方法涉及使用在手持式消融导管的外壳中提供的电池在手持式消融导管内产生超声波能量。该电池充当用于在手持式消融导管的外壳中提供的超声波发生器的唯一功率源。该方法还涉及沿着被耦合到把手单元和在导管的远端处提供的超声波换能器并位于身体的目标组织内或接近于身体的目标组织定位的导管传送由超声波发生器产生的声能。该方法还涉及使用由超声波换能器产生的超声波能量来消融目标组织。根据一些方法,该发生器向超声波换能器供应足以消融邻近于病人肾神经的血管周围肾组织的功率。
根据其他实施例,一种自供电消融导管包括RF消融布置和超声波布置。在一些实施例中,该超声波布置在扫描或成像模式下操作,并且RF消融布置***作以消融目标组织。超声波布置例如可以用来对目标组织进行定位、通过在过程期间扫描目标组织来监视消融的进展和/或随后扫描被消融组织以检验消融的效果。在其他实施例中,可以将自供电消融导管的RF消融布置和超声波消融布置用于消融目标组织,并且还可以将超声波布置用于扫描或成像。例如,可以根据目标组织的类型和使用环境串联地或单独地使用不同的消融布置。
在一些实施例中,可以将单个换能器配置成用于RF消融和超声波消融两者和/或扫描或成像。包括导电涂层或元件(例如,在超声波换能器处或接近于超声波换能器的连接器或环状结构)的超声波换能器可以充当组合RF消融和超声波换能器。可以将单独的发生器容纳在自供电消融导管的把手单元中。替换地,可以使用在适合于驱动RF消融元件和超声波换能器的频率范围内产生能量的单个发生器。
鉴于以下详细讨论和附图,可以理解这些及其他特征。
附图说明
图1是包括从腹主动脉横向地分支的肾动脉的右肾和肾脉管***的图示;
图2A和2B图示出肾动脉的交感神经支配;
图3A图示出肾动脉的壁的各种组织层;
图3B和3C图示出肾神经的一部分;
图4示出了根据各种实施例的包括手持式自供电RF消融导管和病人监视器的***;
图5示出了根据各种实施例的结合了冷却特征的自供电RF消融导管;
图6示出了根据各种实施例的自供电消融导管的用户接口;
图7示出了根据各种实施例的自供电消融导管;
图8示出了根据各种实施例的容纳引导线的自供电消融导管;
图9示出了根据各种实施例的适合于向自供电消融导管的电极布置供应RF能量的消融电路的典型示意图;
图10示出了根据各种实施例的结合了超声波换能器的自供电消融导管;
图11示出了根据其他实施例的结合了超声波换能器的自供电消融导管;以及
图12示出了根据各种实施例的结合了超声波换能器和柔性系链的自供电消融导管。
具体实施方式
本公开的实施例针对用于消融人体的目标组织的装置和方法,诸如神经支配组织、心脏组织、器官组织、血管、肿瘤以及患病组织(内部和外部)。本公开的实施例针对用于消融血管周围肾神经以用于高血压治疗的装置和方法。装置和方法针对自供电消融导管及其用于向人体内的目标组织输送消融治疗的使用。
本公开的各种实施例针对消融装置和消融的方法,其包括或使用优选地被配置成用于手持式操纵的自供电消融导管。各种实施例针对消融装置和消融的方法,其包括或使用自供电消融导管,该自供电消融导管使用标准电池或多个标准电池作为用于超声波能量源的唯一功率源。各种实施例针对消融装置和消融的方法,其包括或与外部病人监视器相组合地使用自供电消融导管。根据一些实施例,一种自供电消融导管包括RF消融布置。在其他实施例中,一种自供电消融导管包括超声波消融布置。
邻近于肾动脉的肾神经的射频消融是正在出现的用于顽固性高血压的疗法。常规RF消融***使用被连接至相对大的病人外部RF发生器控制台的消融导管,该病人外部RF发生器控制台是类似于传统RF消融***的控制台。此类常规RF消融***是大的、昂贵的并且维修和供应起来费用大。
本发明人已经确定,相对于诸如用于心律不齐治疗的心脏组织的消融的常规RF消融应用,使用高频AC能量(例如,RF或微波能)的肾去神经具有小得多的能量要求。根据本公开的实施例,用于每个肾神经消融的功率要求通常不超过8瓦(按尖端温度用滴定法测量),其一般被施加最多两分钟。在过程中要求的损伤的数目通常不超过八个,在每个肾动脉中为四个。八次消融所需的总能量明显小于心脏心律不齐的消融所需的典型能量。即使在较高功率消融过程中,诸如涉及针对每个肾动脉达到最多四分钟的30瓦的最大功率的那些,两个常规AA锂电池通常提供用于此类过程的足够能量。本发明人进行的实验和分析已显示用于使用高频AC能量的肾去神经的能量要求小到足以考虑包含在消融导管的把手中的电池操作发生器。各种实施例针对用完全包含在消融导管的把手内的相对低成本电子装置(其可以是一次性的)来替换相对昂贵的高频AC发生器资本设备。
自供电消融导管的各种实施例可以提供消除了对跨越无菌场的电引线的需要、无维护以及无服务合同中的一个或多个。自供电消融导管的各种实施例可以提供单操作员使用(不需要技术人员)、减少的导管实验室库存和储存空间以及减少的行政工作中的一个或多个。本公开阐述了根据各种实施例的用于自供电肾神经消融的能量要求的计算,并且证明了常规电池能够为RF消融布置和超声波消融布置供应此能量。
根据结合了RF消融布置的各种实施例,一种高效的开关电源被配置成作为典型RF发生器进行操作。可以针对根据其他实施例的采用微波发生器的自供电肾神经消融设备实现类似电路。
在各种实施例中,一种冷却装置或机构被用来冷却消融尖端以使邻近于尖端的组织免于受到过热的伤害,并且使热量更深地投射到动脉壁中至肾神经的部位。应注意的是结合了超声波消融布置的各种实施例由于在没有热损害中间组织的情况下使超声波能量聚焦于目标组织处的提高的能力而可以不需要冷却机构。例如,可以通过循环气体或流体和/或通过尖端处的气相变化或焦耳-汤姆逊效应冷却来在导管内提供冷却。可以在导管的消融区域处结合热电偶或其他传感器。可以利用单极或双极电极布置。可以使用通过导线、固定导线或无导线***,根据需要具有引导护套或导管以适当地对消融导管进行定位。
本公开的各种实施例针对用于治疗高血压的用于肾去神经支配的装置和方法。高血压是其中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***的亢进与高血压及其进展相关联。经由肾去神经支配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。
肾有助于许多人体过程,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。肾通过从腹主动脉左右分支、在肾的凹面、肾门处进入每个肾的肾动脉接收心输出量的约20—25%。
血液通过肾动脉和输入小动脉流入肾,进入肾的过滤部分,肾小球。肾小球由血管小球、称为肾小囊的被充满体液的杯形囊围绕的毛细管丛组成。由于存在于毛细血管中的血压与肾小囊中的流体之间的的压力梯度,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流体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,诸如钠和氯化物的营养素、水和电解液被再吸收到血液中。
肾是是受肾丛神经支配的,该肾丛主要源自于主动脉神经节。肾神经节随着神经遵循肾动脉的路线并进入肾而由肾丛的神经形成。肾神经是自主神经***的一部分,其包括交感和副交感分量。交感神经***被称为提供人体“战斗或逃走”响应的***,而副交感神经***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。此过程称为肾素血管紧张素醛固酮***(RAAS)响应以增加肾交感神经活动。
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,并且还刺激激素醛固酮从肾上腺皮质的分泌。醛固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***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***的***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,身体不堪重负,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是包括从腹主动脉20横向地分支的肾动脉12的右肾10和肾脉管***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右肾及关联肾脉管***和神经***结构两者进行参考,其在本公开的实施例的背景下全部被设想到。肾动脉12被有目的地证明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。
左右肾被从左右肾动脉供应血液,左右肾动脉从腹主动脉20的相应左右横向表面分支。左右肾动脉中的每一个被指引跨越橫膈腳,从而与腹主动脉20几乎形成直角。左右肾动脉大体上从腹主动脉20延伸至接近于肾的肾门17的相应肾窦,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%,其对于正常人而言表示每分钟通过肾的约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***的激素的产生中起重要作用。
肾的重要辅助功能是控制人体的新陈代谢的体内平衡。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***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等离子体离子浓度(例如,钠、钾、氯化物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、通过防止有价值营养素的***来将其保留并帮助肝排毒来使血液pH稳定。
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类固醇和儿茶酚胺的合成来调节人体的应力响应,分别包括皮质醇和肾上腺素。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***衍生出的筋膜陷凹。
人体的自主神经***控制血管、消化***、心脏和腺中的平滑肌的不自主动作。自主神经***被划分成交感神经***和副交感神经***。一般而言,副交感神经***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***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***中,源自于中枢神经***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***的激活。肾上腺素的此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图示出肾脉管***的交感神经支配,主要是肾动脉12的神经支配。肾脉管***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***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***进行神经支配。腹腔神经节28被更大的胸内脏神经(更大TSN)所接合。主动脉神经节26被较小胸内脏神经(较小TSN)接合并对多半的肾丛进行神经支配。
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肾脉管***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。交感神经交通穿过交感干神经节,在那里,一些可以形成突触,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。突出前副交感信号在其在肾10上或附近形成突触之前行进至肾10附近的位置。
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内衬有控制肾动脉内腔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-收缩耦合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***收缩或松弛,但是还可以应来自相邻细胞的刺激和响应于激素和血液产生的电解液和媒介(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***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以大体上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中所描绘的。
肾动脉12的平滑肌34处于自主神经***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,这减小肾动脉内腔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内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,同时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,并且图示出肾动脉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是接触流过脉管内腔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,并且具有清楚的圆形或椭圆形核。在多血管功能中涉及内皮30的细胞,包括经由血管收缩和血管舒张、血液凝固的血压控制,并且充当内腔13内的内含物与周围组织之间的阻挡层,诸如将内膜32与介质34分离的内膜32以及外膜36的薄膜。内膜32的薄膜或离析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是介质33,其是肾动脉12的中间层。该介质由平滑肌34和弹性组织构成。通过其色彩及通过其纤维的横向布置,可以很容易地识别介质33。更特别地,介质33主要由以薄板状方式或薄片布置并循环地设置在动脉壁15周围的成束平滑肌纤维34组成。肾动脉壁15的最外层是外膜36,其由***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。
示出了邻近于肾动脉壁15的外膜36和在其***的血管周围区域37。示出了接近于外膜36且通过血管周围区域37的一部分的肾神经14。示出了沿着肾动脉12的外壁15基本上纵向地延伸的肾神经14。肾神经14的主干一般存在于肾动脉12的外膜36中或上,常常通过血管周围区域37,其中某些分支行进至介质33中而使肾动脉平滑肌34衰弱。
可以将本公开的实施例实现为向受神经支配的肾脉管***提供不同程度的去神经支配治疗。例如,本公开的实施例可以提供由使用本公开的治疗装置输送的去神经支配治疗实现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),其用于分离和支撑神经纤维14b和束14a。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***,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。轴突终末包含突触,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***的许多神经元的轴突被入鞘在髓鞘质中,其由称为Schwann细胞的一种胶质细胞形成。髓鞘雪旺细胞缠绕在轴突周围,使得轴膜在称为Ranvier的节点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。
在一些实施例中,可以将本公开的治疗装置实现成的输送去神经支配治疗,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装置实现成输送去神经支配治疗,其对肾神经纤维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装置实现成的输送去神经支配治疗,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,可以将治疗装置实现成输送去神经支配治疗,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装置实现成通过对符合神经失用症(neruapraxia)的肾神经纤维14b给予损伤来中断神经脉冲沿着肾神经纤维14b的传导。神经失用症描述了其中不存在神经纤维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的情况,在没有实际再生的情况下恢复在几小时至几个月内发生,因为未发生华勒氏变性。华勒氏变性指的是其中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。神经失用症是轻度的神经损伤,其可以通过使用根据本公开的实施例的治疗装置来给予肾神经纤维14b。
可以将治疗装置实现成通过对符合轴突断伤的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。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覆盖,但保留了神经纤维的***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,发生华勒氏变性。从轴突断伤的恢复仅通过轴突的再生的发生,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。
可以将治疗装置实现成通过对符合神经断伤的肾神经纤维14b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,使神经纤维14b和神经鞘两者中断。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***14c的连续性的损失,在肾神经纤维14b的情况下,导致植物神经机能的完全丧失。如果神经纤维14b已被完全划分,则轴突再生促使神经瘤在最近的残端中形成。
通过参考如在本领域中已知的Sunderland***,可以找到神经断伤神经损伤的更多层的分类。Sunderland***定义了五个程度的神经损伤,其中的前两个与Seddon分类的神经失用症和轴突断伤紧密地相对应。后三个Sunderland***分类描述不同水平的神经断伤神经损伤。
Sunderland***中的第一和第二程度的神经损伤分别类似于Seddon的神经失用症和轴突断伤。根据Sunderland***,第三程度神经损伤涉及神经内膜的中断,其中神经外膜和神经束膜保持完好无损。根据束内纤维化程度,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,其中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。
参考图4,示出了根据各种实施例的包括自供电消融导管200和病人监视器110的医学***100。自供电消融导管200包括外壳201,其被配置为用于由临床医生进行手持式操纵的把手单元220。外壳201包括许多部件,该许多部件包括被耦合到电池208的RF发生器204。RF发生器204被配置成使用储存在电池208中的能量来产生足以实现肾去神经的能量。如在本文中更详细地讨论的,电池208优选地包括一个或许多常规的容易获得的电池。电池优选地是一次性的。电池208优选地充当用于至少RF发生器204的唯一功率源。优选的是电池208充当用于消融导管200的所有部件的唯一功率源。
外壳201支撑用户接口206,其包括许多开关和促进由临床医生进行的自供电消融导管200的控制的一个或多个显示器。根据图4中所示的实施例,在外壳201中或上还包括导向控制机构215。导向控制机构215意图表示允许临床医生将导管218的近端230指引至诸如病人肾动脉的目标位置的各种已知导向机构。
在一些实施例中,外壳201可以包括被配置成实现与病人监视器110或其他设备的通信电路122的通信的通信电路210。图4中所示的病人监视器110包括显示器112和包括多种控制机构和开关的控制面板114。虽然病人监视器110是可选设备,但显示器112、存储器(未示出)以及病人监视器110的其他特征可以提供对临床医生有用的加强反馈和信息。应理解的是自供电消融导管200可以用来在不需要病人监视器110或其他设备的情况下执行消融过程。
存储在消融导管200内和/或从消融导管200传送的数据优选地包括消融开始和停止时间、执行消融的次数、电池剩余寿命、温度、消融期间的阻抗和功率对比时间等中的一个或多个。此数据还可以包括消融期间的RF电压和电流振幅(和温度)。在一些实施例中,可以将通信电路210配置成用于双向通信。在其他实施例中,可以将通信电路210配置成用于单向通信。
可以经由通信接口120将病人监视器110通信地耦合到病人信息管理***,并且可以将从消融导管200接收到的数据传输至病人的医学记录中。还可以经由显示器112在病人监视器110上显示该数据,例如作为温度和功率对比时间。可以显示本文所述的其他参数和病人相关信息。
如图4中进一步示出的,导管218被耦合到把手单元202。导管218包括具有近端、远端230以及在近端和远端之间延伸的内腔布置222的柔性轴220。轴220的长度足以从经皮位置接近病人的肾动脉。一个或多个电导体224优选地在内腔布置222内沿着轴220延伸。在轴220的远端230处提供了电极布置233且其被耦合到电导体布置224。
在一些实施例中,导管218经由耦合器被可拆卸地耦合到把手单元202,允许消融过程之后的导管218的替换和把手单元202的再使用。耦合器促进导管轴220、内腔布置222以及电导体224之间的机械、射流(可选)和电耦合两者。在其他实施例中,导管218被永久性地连接到把手单元202,使得整个消融导管200是一次性的。
在一些实施例中,电极布置233包括至少两个电极234、238,其在双极模式下操作。在双极配置中,优选的是返回电极235在表面面积方面明显大于消融尖端电极234以便防止或减少邻近于返回电极的加热。在其他实施例中,可以将单个消融电极234与外部电极一起使用以便在单极模式下操作。自供电消融导管200在双极模式下操作、使得不需要外部返回电极可能是优选的。
在图4中,轴220的远端230处的电极布置233包括以间隔开的关系布置的一对电极234、236。电极对的消融电极234优选地位于轴220的尖端238附近。此返回电极236优选地与远侧电极234在约30 mm和300 mm之间间隔开。电极234和236优选地具有在约1mm和2mm之间的直径。消融电极234优选地具有在约1mm和4mm之间的长度且返回电极236优选地具有在约4mm和50mm之间的长度。导管轴220的尖端238优选地被构造为柔性防损伤尖端。
示出了位于或接近于消融电极234处的温度传感器235。温度传感器235被用来测量邻近于消融电极234的动脉壁处的温度。如果需要的话,可以包括一个或多个附加温度传感器235,诸如在返回电极236处或接近于返回电极236的近侧温度传感器235。由一个或多个温度传感器235提供的温度信号优选地被传送至设置在自供电消融导管200的外壳201中的处理器。该温度传感器信息可以用来自动地调整由RF发生器204产生的能量以在消融期间保持适当的组织温度。
参考图5,示出了结合了冷却特征的自供电消融导管200的实施例。根据图5,自供电消融导管200的外壳201包括冷却剂控制机构310,其提供临床医生对冷却剂305从外部冷却剂源300至轴220的远端230的远端230输送的控制。根据一些实施方式,把手单元202包括被流体地耦合到导管轴220的内腔布置222的冷却剂内腔和被流体地耦合到冷却剂源300的供应管303。冷却剂控制机构310包括允许冷却剂分配速率和冷却剂温度的临床医生调整的一个或多个控制机构。冷却剂源300通常包括被流体地耦合到泵的储器。在储器内包含冷却剂305。在简单实施例中,冷却剂是被提起的一袋无菌盐水,并且泵送手段是重力。室温下的盐水相对于体温而言是冷的。
在一些实施例中,自供电消融导管200的冷却布置是闭合***,其中,用过的冷却剂305被从轴220的远端230返回至冷却剂源300。例如,在闭合冷却布置中可以采用多种冷却剂,包括冷盐水或冷盐水和乙醇混合物、氟利昂或者其他碳氟化合物冷冻剂、氧化亚氮、液氮以及液态二氧化碳。在一些实施例中,当冷却剂305在导管轴220的远端230处的冷却室内部被释放时经历相变,该相变诸如通过焦耳-汤姆逊效应将导管轴220的远端230冷却。
在其他实施例中,使用生物相容冷却剂作为冷却剂305,允许将用过的冷却剂305通过排出孔布置从导管轴220的远端230排出。用于开放冷却布置的适当冷却剂包括冷无菌盐水、Ringer溶液或其他血液相容流体。在图5中所示的实施例中的电极234和236中的一者或两者处或其附近的一个或多个温度传感器235的包合允许肾去神经期间的RF能量和冷却剂的自动输送和调整。
图6示出了根据本公开的实施例的手持式自供电消融导管200的用户接口206。用户接口206包括功率部410、温度部420、可选冷却部430、导向控制部215以及可选音频输出部450。功率部410被示为包括功率控制机构414、通电开关416、断电开关418以及显示器412。还可以提供阻抗显示器402以指示实际阻抗值或者组织阻抗在预定义阻抗范围内或外面的指示(例如,色彩)。
温度控制部420被示为包括温度控制机构424和温度显示器422。冷却部430被示为包括ON开关436、OFF开关430以及冷却剂供应控制机构432。音频输出部450包括扬声器455,并且可以另外包括麦克风。该麦克风可以用来记录在消融过程期间由临床医生进行的评论。麦克风还可以用来实现由临床医生发出的语音激活命令,诸如功率、温度、冷却剂输送以及导向命令中的一个或多个。其他显示特征可以包括用于通电和断电或故障条件的一个或多个指示灯。定时器可以显示所经历的消融时间,并且可以对预置消融持续时间进行倒计时。
图7示出了根据本公开的各种实施例的手持式自供电消融导管200。在图7中所示的实施例中,在消融导管200的外壳201上提供了许多开关和显示器。优选地由把手外壳201上的软键来控制控制ON/OFF和UP/DOWN(以瓦特为单位)的功率状态,并且在被结合到把手外壳201中的一个或多个显示屏上显示。例如,并且如图7中所示,功率部410包括功率增加开关413(UP增加开关)、功率减少开关415(DOWN增加开关)、ON开关416以及OFF开关418。功率部410还包括功率显示器412,其在图7的典型图示中示出5.6W。
温度部420同样地包括温度增加开关421(UP增加开关)和温度下降开关423(DOWN增加开关)。温度部420包括温度显示器422a和422b。温度显示器422a示出了由临床医生设定的温度,其在本说明性实施例中被示为55℃。在温度显示器422b中示出了由轴220的电极布置233处的温度传感器235感测的实际温度,其在本说明性实施例中示出了51℃的温度。本实施例中的阻抗显示器402包括阻抗指示器403。阻抗指示器403优选地指示阻抗为绿色的“在范围内”和红色的“在范围之外”。应理解的是其他色彩和指示可以用来指示组织阻抗的状态。
把手单元202还包括允许临床医生操纵导管218的轴220的导向控制机构215。可以例如使用可操纵导管机构、诸如与在电生理学(EP)导管中使用的那些类似的结构来控制导管轴220的尖端238的偏转。
图8示出了根据本公开的各种实施例的自供电消融导管200。在图8中所示的实施例中,出于使导管轴220前进至目标位置、诸如病人的肾动脉的目的采用引导线502。在本实施例中,把手202包括被耦合到导管轴220的内腔布置222的引导内腔的引导线内腔或通道。可以将引导管503连接到把手202的近端以促进引导线502到和从把手202的容易的前进和收回。可以使用各种已知的通过导线技术来使导管轴222前进至病人的肾动脉。应注意的是内腔布置222可以包括用于在肾动脉壁处提供冷却的开放和闭合冷却剂分配/循环装置。
根据各种实施例,诸如在图4—8中示出的那些,自供电消融导管200的所有或特定部件优选地被实现成是一次性的。在一些实施例中,整个消融导管设备200被实现成是一次性的。在其他实施例中,把手单元202被实现成是可再使用的,而导管部220被实现成是一次性的。
在其实验/分析中,发明人考虑使用达到2分钟的最长时间的8瓦的最大功率来在两个肾动脉中的每一个中的四个点处进行消融所需的能量。单个消融所需的能量是8瓦乘以120秒或960焦耳。在最大功率和时间设置下产生八个损伤所需的总能量则是7,680焦耳。
自供电消融导管200(图9)的消融电子装置所消耗的能量将可能超过此值,但是调制解调器开关电源是非常高效的,并且使用此能量的一小部分,并且很重要的是不将把手单元202加热。测量和显示电子装置使用最小功率。保守地说,针对约15,000焦耳的功率要求,消融能量要求被乘以二。
单个AA碱性电池能够供应超过12,000焦耳,而锂AA能够供应此能量的两倍(约24,000焦耳)。因此,根据本公开的装置和方法,两个碱性或一个锂AA电池能够供应肾去神经治疗程序所需的能量。
根据一些实施例,较高功率肾动脉去神经过程可以涉及在每个肾动脉中执行约4至5次消融(每次将RF电极重新定位)。假设单次消融所需的能量是8瓦乘以120秒(2分钟)或者960焦耳,在约7,680至约11,520焦耳之间的最大功率和时间设置范围下的产生在八个和十二个损伤之间所需的总能量。保守地说,针对在约15,000和23,000焦耳之间范围内的功率要求,可以将用于此典型示例的消融能量要求乘以二。一个AA锂电池或两个AA碱性电池的容量可以供应此较高功率过程所需的能量。
根据其他实施例,可能期望在较高功率下且在较长持续时间内但在不需要每个肾动脉中的多次消融的情况下执行血管周围肾神经组织的RF消融。此类较高功率肾动脉去神经过程可能要求对于每个动脉而言达到约4分钟的在约12至24瓦之间(且可能高达约30瓦)的容量。此典型较高功率肾动脉去神经过程所需的总能量(即,对每个动脉使用12至30瓦多达4分钟)在约5,760至约14,400焦耳之间的范围。保守地说,针对在约11,500和29,000焦耳之间范围内的功率要求,可以将用于此典型示例的消融能量要求乘以二。两个AA锂电池的容量(约48,000焦耳)可以供应此较高功率过程所需的能量。
应理解的是可以将自供电消融导管的一些实施例实现成容纳更大的电池(例如,大于AA电池,诸如C或D电池)和/或多于两个电池(例如,3或4个AA电池),取决于特定消融导管设计的功率要求。在此类实施例中,可以使得自供电消融导管的外壳更大以容纳更大和/或更多的电池。然而,自供电消融导管的把手单元应仍是经济上高效的,从而避免过度地限制临床医生在执行病人两个肾动脉中的每一个中的消融所需的时间段期间操纵消融导管的能力。
可以根据组织电阻的典型值来估计在8瓦的平均功率下进行消融所需的RF电压振幅。在组织中产生的欧姆热量是由V2/2R给定的。将其设置成等于8瓦且使用100欧姆的典型组织电阻产生40伏的电压振幅。当前振幅等于V/R或0.4安培。
在各种实施例中,可以由两个40伏电池(+/-40伏)对开关电源进行供电,其可以由例如串联的四个A23 12伏电池组成,产生48伏电池。并联的这些纽扣电池的三个堆叠大致上是AA电池的体积。此电池组将容易地供应所需的0.4 安培振幅或280 mA RMS电流。
参考图9,示出了根据各种实施例的自供电消融导管200的消融电路600的典型示意图。消融电路600包括适合于向消融电极234和236供应消融功率的开关电源。图9中所示的电路600小到足以安装在消融导管200的把手单元202内。电池612通过将开关610开启和关断来供应被转换成脉冲DC电压的DC电压。电容器616阻断来自电极234和236的DC电压,并且用LC部件的平滑化动作,将脉冲DC电压转换成具有电池612的振幅的一半的正弦波电压。根据典型示例,电池612可以由串联连接的两个40伏电池,或者一个80伏电池组成。可以采用其他电路,其在40伏电池之间切换以产生+/-
40伏正弦波。
在典型操作模式下,微处理器604以期望的RF消融频率、例如480 kHz开启和关断。LC电路618、616将开/关方波转换成被输送到组织电极234和236以用于消融的正弦波。消融仅在尖端电极236周围发生,因为其具有足够小的面积以产生达到足以提高组织温度的电流密度。在一些实施例中通过输送RF功率的突发并调整突发之间的关闭时间(占空因数调制)来控制输送到组织的功率。占空因数可以是单独480 kHz循环的关闭时间或由许多480 kHz循环组成的突发的关闭时间。
来自消融尖端温度计235的反馈被反馈至微处理器604以自动地控制尖端温度。来自导管电极620和622的反馈测量被用来例如在感测到相对于(例如且不超过)阈值的阻抗上升的情况下关断功率的组织阻抗。电极620和622中的一者或两者可以与电极234和236相同。还测量组织电压且乘以测量的RF电流且求平均以计算被输送到组织的RF功率,其被调整直至达到设定温度或设定功率为止。
图9中所示的电源612(例如,串联的2个40伏电池或一个80伏电池)可以供应约+/-40伏的峰值RF电压,或者升压调节器(VREG)606可以使电池电压升压,例如从约3至约80伏。电容器614在开关610打开时被充电,并且在开关610被闭合时提供快速电流流动,从而防止电池电压612中的跌落或下降。微处理器604控制高效开关610,例如FET,以向组织电极234和236输送开和关电压脉冲。电感器618和电容器616形成被调谐至开关频率的储能电路,并且对方波进行滤波以形成在电极234和236处输出的正弦波。
典型RF消融频率是480 kHz。例如通过调整被输送至电极234和236的RF能量的占空因数来控制组织功率。来自尖端温度计235的信号和在电极620和622处测量的组织阻抗被反馈至微处理器604以自动地控制例如占空因数的功率,以保持恒定的尖端温度,并在阻抗上升至设定极限以上的情况下关断功率。
在各种实施例中,例如,作为图4中所示的导管承载返回电极的替代,可以使用常规返回电极。衬垫将在无菌场中被打开,附着于病人,并用插头***消融导管200的把手单元202中。
一般地,当肾动脉组织温度上升至约113°F(50℃)以上时,蛋白质被永久性地破坏(包括肾神经纤维的那些)。如果加热至约65℃以上,则胶原变性且组织皱缩。如果加热至约65℃以上且高达100℃,则细胞壁破裂且油与水分离。在约100℃以上,组织脱水。根据一些实施例,消融电路600被配置成将消融电极234处的电流密度保持在足以促使目标组织优选地加热到至少55℃的温度的水平。
优选消融导管实施例将使邻近于消融电极的动脉平滑肌组织免受伤害,同时消融邻近于动脉壁外面的肾神经(即,血管周围肾神经和神经节)。这可以通过以前述方式冷却消融尖端、同时穿透超过冷却区的电流仍能够将神经加热和消融来实现。在一些实施例中,可以采用冷却或低温导管***(例如,气囊导管)的小型化型式,具有明显减小的冷却体积。可以采用其他冷却装置和机构,包括使被冷却液体或气体循环、在消融尖端处将流体转换成气体和/或使气体通过尖端内的喷嘴以经由焦耳-汤姆逊效应进行冷却。在一些实施例中,可以向尖端电极234中结合小型珀尔帖效应固态冷却器。
如先前所讨论的,消融导管200的把手单元202可以包括通信设施。在图9的示意图中,例如,示出了由调压器606供电并由微处理器604控制的通信设备608,虽然可预期其他配置。可以将通信设备608配置成用于与病人监视器或其他外部***的双向或单向无线和/或有线通信。
例如,通信设备608可以实现无线通信协议,例如,诸如蓝牙或紫峰(Zigbee)。除了别的之外,其他适当的无线协议包括医学植入通信服务(MICS)、工业、科学及医学(ISM)以及近程设备(SRD)协议。在一些实施例中,可以使用自供电消融导管200与病人监视器110(或其他设备或***)之间的有线连接作为主通信链路或辅助/备用通信链路(例如主无线链路的辅助/备用)。除了别的之外,适当的有线通信协议包括有线以太网(IEEE 802.3)、Fire
Wire™和USB协议。在一些混合实施例中,可以使用来自USB电缆的功率以及电池208(或者将其排除在外)。在一些实施例中,例如,可以使用USB电缆来对自供电消融导管200的标准可再充电电池208(例如,锂离子电池)再充电。可以在自供电消融导管200的使用之前去除USB电缆。
现在参考图10—12,图示出了自供电消融导管1000、1100、1200的各种实施例,其包括根据本公开的各种实施例的超声波消融布置。虽然RF肾神经消融看起来是可行的方法,但超声波肾神经消融以较少的动脉壁损伤提供更有效的消融。作为示例,位于肾动脉的中心处的圆柱形超声波换能器产生被消融组织的周向环。动脉壁通过血流冷却而免受消融的损伤。导管尖端可以包含定中心装置,诸如球囊或一个或多个定中心篮状物。周向超声波消融所需的能量小到足以允许标准电池功率的使用。根据本公开的实施例的超声波消融***与RF方法相比时更快且更容易供临床医生使用。
常规超声波控制台要求单独的超声波功率发生器,并且对于临床医生而言是麻烦的,要求到导管的系链连接和到壁电插件的连接。由于系链连接,适当地保持无菌场也不必要地复杂。耐用的超声波控制台通常是客户的显著资本购买品,具有附加成本和批准。在不使用时必须将控制台储存,并且维护和校准可能是个问题。根据各种实施例,导管把手中的自备功率发生器消除了与常规RF方法相关联的对系链连接、功率插件、资本购买品、维护以及储存困难的需要。
根据一些实施例,期望的是图可以将图10—12中所示的自供电消融导管1000、1100、1200实现为相对低成本的设备,其中至少设备的导管部分是一次性的。在一些实施例中,期望的是将整个自供电消融导管1000、1100、1200实现为低成本和一次性设备。如下面将描述的,诸如自供电消融导管1000、1100、1200的低成本和一次性的属性大体上是通过实现具有能够使用标准常规或家用电池能够容易地满足的功率要求的设计而实现的。
图10—12中所示的实施例包括导管1003和被耦合到导管1003的把手单元1001。导管1003包括柔性轴1004,其在长度方面足以接近病人身体的目标组织,诸如病人的肾动脉或身体的其他组织。在轴1004的远端处提供了超声波换能器1006且其被耦合到沿着轴1004延伸的一个或多个电导体。
把手单元1001包括被配置成用于手持式操纵的外壳1002。在外壳1002中提供了电池1010和功率发生器1015中的每一个。电池1010经由可以配置为ON/OFF开关的电源开关1012被耦合到功率发生器1015。可以将ON/OFF开关1012或第二ON/OFF开关实现成将功率发生器1015激活和去激活。控制电路1018被耦合到电池1010和从把手单元1002、沿着导管轴1004延伸且被耦合到超声波换能器1006的一个或多个电导体。控制电路1018包括控制器和存储器,其进行配合以控制自供电消融导管1000、1100、1200的各种功能。可以将控制电路1018配置成允许临床医生调整有限数目的操作参数,例如,诸如选择循环持续时间和占空因数。用户接口1020/1022可以包括促进与消融导管1000、1100、1200的临床医生交互的各种指示器和开关。
自供电消融导管1000、1100、1200可以包括一个和多个传感器,诸如用以检测超声波换能器1006的过热的温度传感器。可以在外壳1001上提供各种显示器1020/1022以向临床医生指示各种类型的信息。可以在外壳1001上包括传感器指示符显示器1020并实现成指示各种类型的信息和警告,例如,诸如温度过高指示、故障状况、ON-OFF状态以及适当的操作指示符。可以提供定时器显示器1022以示出用于消融过程的消融持续时间或剩余时间。
可以将自供电超声波消融导管1000、1100、1200的各种实施例配置成供前述类型的外部病人监视器使用,诸如图4中所示的病人监视器110。可以在外壳1002、1210的把手电子装置中包括通信设备,诸如图9中所示的通信设备608。可以在包括本公开的自供电超声波消融导管1000、1100、1200的各种实施例的背景中结合上文所讨论的病人监视器110的自供电RF消融导管的所选部件、特征和功能。
电池1010优选地充当功率发生器1015的唯一功率源。更优选地,电池1010充当用于要求功率的自供电消融导管1000、1100、1200的所有部件的唯一功率源。功率发生器1015和超声波换能器1006被配置成使用储存在电池1010中的能量来产生足以消融人体的目标组织的超声波能量。
本发明人所执行的计算机模拟指示能够由小的常规电池来容易地供应双侧肾神经消融所需的能量。例如,已确定双侧肾神经消融所需的能量要求约2,000焦耳。常规锂AA电池能够提供约24,000焦耳,这很容易满足用于根据各种实施例实现的自供电超声波消融导管1000、1100、1200的双侧肾神经消融的功率要求。有利地,不需要接地衬垫和到控制台的连接以便执行根据本公开的实施例的超声波消融。
假设电池能量的约一半作为换能器热量被浪费,可以使用约6瓦来实现由超声波进行的周向消融。如果要求2分钟的消融持续时间,每个肾动脉约720焦耳,则双侧肾神经消融将花费小于约1,400焦耳。2,000焦耳的电池容量将允许有额外的容量。标准碱性AA电池例如保持约12,000焦耳,并且锂AA电池保持约24,000焦耳,如前所述。由于自供电超声波消融导管1000、1100、1200的功率要求是如此低,所以可以将多种串联和并联电池布置与廉价且容易获得的电池一起使用以实现期望的能量容量、电压、电流消耗以及储存寿命,具有小的重量和体积。
在图10中所示的实施例中,功率发生器1015包括递升DC至DC转换器1014,其能够用来将低电池电压变换成较高电压以对超声波换能器1016进行供电。简单振荡器电路1016提供所需频率。替换地,并且参考图11,提供了振荡器电路1114以将DC电池功率转换成AC功率。可以使用常规AC变换器1116来使电压递升以对超声波换能器1006供电。可以使用其他振荡器/变压器/转换器布置。还可以使用各种混合布置。
在图12中所示的实施例中,可以经由柔性系链1205将小导管把手1210系链连接至放置在附近工作台上的控制单元1220几英寸。优选地将整个***1200永久地连接在一起并配置成用于一次性使用(一次性)。可以使用与控制单元1220类似的电池供电系链连接控制单元,但是具有可再充电或可替换电池。虽然图12中所示的配置消除了用于连接到壁装电源的要求,但需要用于系链1205的连接器,其引入无菌、储存和维护问题。因此,完全一次性的方法是优选的。
根据一些实施例,超声波消融导管布置可以包括电动机驱动换能器旋转机构以促进多点或周向消融。例如,根据各种实施例,可以在外壳1002、1210中结合已知微型电动机机构,并耦合到超声波换能器1006。适当的微型电动机机构包括能够用在把手单元1002、1210中提供的电池1010来满足的小的能量要求的那些,具有附加的小控制电路。还可以使用电动化超声波消融方法来结合超声波成像以对消融进行引导和评定。在这种情况下,如果需要直观图像,则可能要求到单独显示器的附加信号连接,其可以是有线或无线连接。替换地,可以在没有实际直观图像显示的情况下使用超声波信号来表征组织变化,例如其中组织变化被检测到且把手单元1002、1210上的简单指示灯用以指示“成功消融”。
可以使用多种技术将自供电消融导管1000、1100、1200输送到人体的目标组织。根据一些实施例,可以使用单独的引导导管来通过人体的各种血管进行导航以接近目标组织,诸如经由上或下主动脉接近目标组织诸如肾动脉。超声波换能器1006和轴1004前进通过引导导管并进入动脉中。如果适用的话,定中心装置被激活,并且执行消融。替换地,可以使自供电消融导管1000、1100、1200的可操纵型式前进通过过程导引器护套(穿透皮肤且提供到动脉***中的进入的短护套),并且前进通过动脉***并转向至肾动脉中且定位于肾动脉内以用于消融。可以在有或没有引导导管的情况下使用通过导线技术,其中,消融导管1000、1100、1200被实现成包括从导管1003的至少近端延伸至超声波换能器1006的引导线内腔,其可以是具有中心空隙的圆柱形状,引导线能够通过该中心空隙。举例来说,引导线通过过程导引器护套前进至目标动脉,并且导管1000、1100、1200通过引导导线前进至目标动脉。可以使用套管针来接近皮下或腹部目标组织,并且可以使超声波换能器1006和消融导管1000、1100、1200的轴104前进至目标组织。可预期其他接近方法。
可以将各种自供电超声波消融导管实施例构造成包括在2011年5月31日提交的共同所有美国临时专利申请序号为61/491,728中描述的任何特征,其被通过引用结合到本文中。可以将各种自供电超声波消融导管实施例构造成包括在2011年4月13日提交的共同所有美国临时专利申请序号为13/086,116中描述的任何特征,其被通过引用结合到本文中。
根据各种实施例,自供电消融导管可以包括RF消融布置和超声波布置。在一些实施例中,例如,使超声波布置在扫描或成像模式下操作,并且操作RF消融布置以消融目标组织。该超声波布置可以用来对适当的(例如无病)目标组织进行定位,通过在过程期间扫描目标组织来监视消融的进展和/或随后扫描被消融组织以检验消融的效果。在一些实施例中,可以将自供电消融导管的RF消融布置和超声波消融布置用于消融目标组织,并且还可以将超声波布置用于扫描或成像。根据目标组织的类型和使用环境,可以串联地或单独地使用RF和超声波消融布置。
鉴于常规RF组织消融发生器在接近500 kHz的频率下操作,并且超声波消融发生器在约1 MHz以上的频率下操作,可以将在500
kHz至10 MHz范围内的频率用于RF和超声波消融两者。根据一些实施例,使用单个消融发生器(例如,公共消融发生器)来串联地(例如,用于并发操作)或单独地(例如,用于可选独立操作)向超声波换能器和RF电极提供功率。
由于超声波换能器通常涂有良导体,诸如金,以实现到换能器的电连接,所以此类金属化表面(例如,圆柱形超声波换能器的外表面)可以与围绕换能器的血液进行接触以提供用于电流的单独RF消融路径。在此模式下,可以通过单个发生器和单个消融元件同时地提供RF和超声波能量以产生两个消融能量的期望组合。两个能量通常具有单独的返回电极。在其他模式下,超声波换能器的导电涂层充当RF电极且超声波换能器被配置成用于扫描或成像。在其他模式下,超声波换能器的导电涂层充当RF电极,并且超声波换能器被配置成用于消融和扫描或成像。
在用于控制高血压的血管周围肾神经消融术的背景下一般地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,诸如从身体的其他血管包括其他动脉、静脉和脉管***(例如心脏和泌尿脉管***和血管)和身体的其他组织(包括各种器官)内执行消融。还应理解的是可以针对皮肤或皮下应用而实现本文所述的类型的自供电RF或超声波消融导管,诸如用于消融病人皮肤上的不规则组织。并且,可以使用除RF发生器之外的高频能量源,诸如微波发生器。
应理解的是即使在前述描述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,但此详细描述仅仅是说明性的,并且可以在细节方面进行变化,尤其是在由各种实施例举例说明的部分的结构和布置方面,达到由用来表达所附权利要求的术语的广泛一般意义所指示的最大程度。
Claims (15)
1.一种装置,包括:
导管,包括:
柔性轴;以及
消融元件,在轴的远端处提供;
以及把手单元,包括:
外壳,其被配置成用于手持式操纵且被耦合到所述导管;
控制电路,在所述外壳中提供;
电池,在所述外壳中提供;以及
发生器,在所述外壳中提供并被耦合到所述电池和所述控制电路,所述发生器被配置成仅使用储存在电池中的能量来产生足以用于消融元件消融人体的目标组织的能量。
2.权利要求1的装置,其中:
所述发生器包括高频AC发生器且所述消融元件包括至少一个RF电极;或者
所述发生器包括超声波发生器且所述消融元件包括超声波换能器。
3.权利要求1的装置,其中:
所述消融元件包括至少一个RF电极;
在轴的远端处提供了超声波换能器;以及
RF电极和超声波换能器中的每一个被耦合到单个发生器或在外壳中提供的相应RF和超声波发生器。
4.权利要求1的装置,其中,在轴的远端处提供了包括导电涂层的超声波换能器且其可在消融模式和扫描或成像模式中的一者或两者下操作,导电涂层充当RF消融元件。
5.权利要求1的装置,其中,所述电池包括:
电池体积,不大于AA电池的体积;或者
不大于两个AA电池的电池体积。
6.权利要求1的装置,其中,由所述电池单独地供电的发生器被配置成:
针对病人的两个肾动脉中的每一个产生约8瓦达约2分钟和约30瓦达4分钟之间;或者
产生约7,700和约12,000焦耳之间;或者
产生约12,000和约30,000焦耳之间。
7.权利要求1的装置,其中,所述发生器位于与被配置成用于手持式操纵且被柔性系链与之耦合的外壳分开的辅助外壳中。
8.权利要求1的装置,包括被配置成向接近于消融元件的非目标组织提供冷却的冷却布置。
9.权利要求1的装置,包括分别由所述外壳支撑的可操纵开关布置和显示布置。
10.权利要求1的装置,其中,导管和把手单元中的一者或两者被配置为一次性单元。
11.权利要求1的装置,包括被至少部分地支撑在外壳中的无线通信设备,该无线通信设备被配置成用于实现所述消融装置与外部病人监视器之间的通信。
12.权利要求1的装置,其中:
所述轴具有足以相对于经皮接近位置接近病人的肾动脉的长度;
所述消融元件尺寸被确定为用于肾动脉内的部署;以及
所述发生器被配置成用于仅使用储存在电池中的能量来产生足以用于消融元件消融邻近于肾动脉的血管周围肾神经组织的能量。
13.一种方法,包括:
使用在消融导管设备的手持式自供电把手单元中提供的电池来供应功率;
由在把手单元内提供的发生器使用由所述电池供应的功率来产生能量,所述电池充当用于所述发生器的唯一功率源;
将所述能量传送至在接近于病人的目标组织定位的导管的远端处提供的消融元件;以及
使用被激励消融元件来消融所述目标组织。
14.权利要求13的方法,其中:
所述能量是由高频AC发生器产生的且所述消融元件包括至少一个RF电极;和/或
所述能量是由超声波发生器产生的,并且所述消融元件包括超声波换能器。
15.权利要求13的方法,其中,针对RF消融元件和超声波换能器产生所述能量,针对所述超声波换能器产生的所述能量可被所述超声波换能器在消融模式和扫描或成像模式中的一者或两者下使用。
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CN110623723A (zh) * | 2019-09-04 | 2019-12-31 | 南京桑迪医疗科技有限公司 | 射频等离子体针刀电极化、热凝、切割手术消炎装置 |
CN113768612A (zh) * | 2021-07-30 | 2021-12-10 | 苏州艾科脉医疗技术有限公司 | 用于导管的高压发射电路及消融工具 |
CN113768612B (zh) * | 2021-07-30 | 2023-12-22 | 苏州艾科脉医疗技术有限公司 | 用于导管的高压发射电路及消融工具 |
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US20120059286A1 (en) | 2012-03-08 |
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