CN104254291A - 重建身体通道的组织或身体通路附近的组织的方法及设备 - Google Patents
重建身体通道的组织或身体通路附近的组织的方法及设备 Download PDFInfo
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Abstract
本发明公开了医疗装置及用于制作和使用其的方法。示例性方法可包括肾去神经治疗方法。该方法可包括使用肾去神经导管系统的导管组件将RF能量治疗输送至肾动脉近侧的组织。去神经系统可包括RF能量发生器,该RF能量发生器由控制器与导管组件联接。该方法还可包括使用导管组件将神经活动刺激施加于肾动脉近侧的组织、使用导管组件评估组织的刺激神经活动反应,以及基于评估的神经活动确定RF能量治疗的参数。
Description
相关申请的交叉引用
本申请基于35U.S.C.§119请求享有以下的优先权:2011年12月23日提交的美国临时申请序列第61/580,141号、2012年1月27日提交的美国临时申请序列第61/632,624号、2012年2月6日提交的美国临时申请序列第61/633,154号、2012年8月29日提交的美国临时申请序列第61/743,238号、2012年8月29日提交的美国临时申请序列第61/743,225号,以及2012年8月29日提交的美国临时申请序列第61/743,237号,这些申请的全部公开通过引用并入本文中。
背景技术
已经开发出各种体内医疗装置来用于医疗使用,例如,血管内使用。这些装置中的一些包括导线、导管等。这些装置由多种不同制造方法中的任一种制造,并且可根据多种方法中的任一种使用。已知的医疗装置和方法中的各个具有某些优点和缺点。不断需要提供备选的医疗装置以及制造和使用医疗装置的备选方法。
发明内容
本公开提供了用于医疗装置的设计、材料、制造方法和使用的备选方案。示例性方法可包括一种用于治疗患有高血压的患者的方法。该方法可包括提供装置。装置可包括沿纵轴线延伸的导管。具有未扩张状态和扩张状态的球囊可联接于导管的端部。球囊可在扩张状态中具有沿纵轴线延伸的多个圆筒形治疗区。多个电极极板组件可安装于球囊。各个电极极板组件可包括支承第一电极极板和第二电极极板的基底,其中各个电极极板具有一对长形的双极电极。各个电极极板组件的电极极板均可沿纵向和沿周向偏离彼此。该方法还可包括使球囊在肾动脉中扩张,以便使电极与肾动脉壁电性联接,并且在各双极对的电极之间驱动双极能量,以便以疗法改变肾动脉周围的神经,使得患者的高血压被缓解。
各个电极极板可包括设置在成对电极之间的温度传感器。使球囊热扩张可使温度传感器与肾动脉壁联接。在一些实施例中,该方法还可包括响应于来自温度传感器的温度信号将能量引导至双极对,以便近似一致地加热壁。
电极极板组件可布置在球囊上,以使电极极板中的至少一些与沿周向相邻的电极极板沿纵向分开。在一些实施例中,该方法还可包括通过使球囊在沿纵向分开的电极极板之间挠曲来使球囊前移到肾动脉中。
另一种示例性方法可包括一种用于治疗身体通路的方法。该方法可包括提供装置。该装置可包括沿纵轴线延伸的导管。具有未扩张状态和扩张状态的球囊可联接于导管的端部。球囊可在扩张状态中具有沿纵轴线延伸的多个圆筒形治疗区。多个电极组件可联接于球囊。各个电极组件可包括远侧电极极板和近侧电极极板。远侧电极极板可通过中间尾部沿纵向与近侧电极极板分开。各个电极极板可包括双极电极对。远侧电极极板和近侧电极极板可在球囊的扩张状态中沿周向偏离彼此。多个电极极板可均沿纵向布置,使得各个圆筒形治疗区包括多个电极极板组件中的至少一个的远侧电极极板和近侧电极极板中的至少一个。各个电极组件的中间尾部可沿纵向方向延伸,使得任何特定电极极板组件的远侧电极极板和近侧电极极板占据球囊上的非相邻的治疗区。该方法还可包括使球囊在身体通路的区段中扩张。区段可沿轴线伸长。该方法还可包括触动电极极板,同时球囊扩张来输送能量至身体通路的区段,使得身体通路的区段接受沿纵轴线的多个非邻接治疗。
对于球囊的各个治疗区,触动电极极板可在身体通路的区段上产生至少一个损伤。损伤可不接触彼此。例如,各个治疗区的至少一个损伤可不与相邻治疗区的至少一个损伤沿轴向重叠。
该方法可包括监测电极组件中的各个处的温度。监测温度可包括使用电极组件中的至少一个来监测使用热感测装置的其双极电极对中的一个的温度,并且/或者监测温度可包括使用电极组件中的至少一个来监测使用另一双极电极对的热感测装置的其双极电极对中的一个的温度。
各个双极电极对可包括多个接地电极和多个有效电极。多个接地电极和有效电极中的各个可沿轴线伸长,并且/或者多个接地电极和有效电极中的各个可横穿轴线伸长。
球囊可具有四个圆筒形治疗区。两个电极组件可联接于球囊,使得各个区包括一个远侧电极极板或一个近侧电极极板。在一些实施例中,三电极组件可联接于球囊,使得两个非相邻圆筒形治疗区中的各个包括两个远侧电极极板或两个近侧电极极板,并且其它两个非相邻圆筒形治疗区中的各个包括一个远侧电极极板或一个近侧电极极板。在一些实施例中,一个特定的圆筒形治疗区可包括一个电极组件的一个近侧电极极板和另外两个电极组件的两个中间尾部。在一些实施例中,一个特定圆筒形治疗区可包括两个不同电极组件的两个远侧电极极板,以及其余电极组件的一个中间尾部。
球囊可具有四个圆筒形治疗区,并且四个电极组件可联接于球囊,使得两个非相邻圆筒形治疗区中的各个包括两个远侧电极极板或两个近侧电极极板,并且另外两个非相邻圆筒形治疗区中的各个包括一个远侧电极极板或一个近侧电极极板。两个不同电极组件的两个远侧电极极板可占据特定的圆筒形治疗区,其中这两个远侧电极极板中的各个由另外两个电极组件中的一个的中间尾部沿周向分开。两个不同电极组件的两个近侧电极极板可占据特定的圆筒形治疗区,其中这两个近侧电极极板中的各个由另外两个电极组件中的一个的中间尾部沿周向分开。
一种示例性装置可包括沿纵轴线延伸的导管。球囊可联接于导管的端部。多个电极组件可安装于球囊。各个电极组件可包括沿纵向分开的第一电极极板和第二电极极板。各个电极组件的电极极板可在球囊的扩张状态中沿周向偏离彼此。多个电极组件可沿纵向布置成使得多个电极组件中的一个的电极极板中的一个沿纵向设置在电极组件中的另一个的电极极板之间。
另一种示例性装置可包括沿纵轴线延伸的导管。球囊可联接于导管的端部。球囊可在扩张状态中具有沿纵轴线延伸的多个圆筒形治疗区。多个电极组件可于球囊。各个电极组件可包括远侧电极极板和近侧电极极板。远侧电极极板可通过中间尾部沿纵向与近侧电极极板分开。各个电极组件可包括双极电极对。远侧电极极板和近侧电极极板可在球囊的扩张状态中沿周向偏离彼此。多个电极极板可均沿纵向布置成使得各个圆筒形治疗区包括多个电极组件中的至少一个的远侧电极极板和近侧电极极板中的至少一个。各个电极极板装置的中间尾部可沿纵向方向延伸,使得任何特定电极组件的远侧电极极板和近侧电极极板占据球囊上的非相邻的治疗区。
球囊可具有四个圆筒形治疗区,并且两个电极组件可联接于球囊,使得各个区包括一个远侧电极极板或一个近侧电极极板。
球囊具有四个圆筒形治疗区,并且三个电极组件可联接于球囊,使得两个非相邻圆筒形治疗区中的各个包括两个远侧电极极板或两个近侧电极极板,并且另外两个非相邻圆筒形治疗区中的各个包括一个远侧电极极板或一个近侧电极极板。
一个特定圆筒形治疗区可包括一个电极组件的一个近侧电极极板和其它两个电极组件的两个中间尾部。
一个特定圆筒形治疗区可包括两个不同电极组件的两个远侧电极极板,以及其余电极组件的一个中间尾部。
球囊可具有四个圆筒形治疗区,并且四个电极组件可联接于球囊,使得两个非相邻圆筒形治疗区中的各个包括两个远侧电极极板或两个近侧电极极板,并且另外两个非相邻圆筒形治疗区中的各个包括一个远侧电极极板或一个近侧电极极板。
两个不同电极组件的两个远侧电极极板可占据特定圆筒形治疗区,其中这两个近侧电极极板中的各个由另外两个电极组件中的一个的中间尾部沿周向分开。
两个不同电极组件的两个近侧电极极板可占据特定圆筒形治疗区,其中这两个近侧电极极板中的各个由另外两个电极组件中的一个的中间尾部沿周向分开。
各个电极极板可包括接地电极和有效电极。
各个电极极板可包括热感测装置。
各个电极组件还可包括从近侧电极极板延伸的近侧尾部。
对于各个电极组件,中间尾部包括中间接地线、中间有效电极线,以及中间热传感器线,并且近侧尾部包括中间有效电极线、中间热传感器线、近侧接地线、近侧有效电极线,以及近侧热感测线。
近侧尾部的宽度可为中间尾部的宽度的近似150%。
中间接地线可在与近侧接地线共用的轴线上延伸。
远侧电极极板的远侧接地电极和近侧电极极板的近侧接地电极可两者都沿与中间接地线和近侧接地线共用的轴线延伸,使得远侧接地电极、中间接地线、近侧接地电极和近侧接地线所有都沿轴线延伸。
另一种示例性装置可包括:包括外表面的可扩张球囊,以及沿可扩张球囊的外表面延伸的多个离散的柔性电路。柔性电路中的至少一些均可包括两个或更多个能量治疗部位。柔性电路中的一些的至少一些部分可定形为至少近似键合于至少一个相邻柔性电路的形状。
柔性电路中的至少一些可均包括远侧电极极板、近侧电极极板、在远侧电极极板与近侧电极极板之间延伸的中间尾部,以及远离近侧电极极板向近侧延伸的近侧尾部。
远侧电极极板中的至少一些可定位成邻近中间尾部,并且其中近侧电极极板中的至少一些可定位成邻近中间尾部。
柔性电路中的一些的至少一些部分可定形成不键合于至少一个相邻柔性电路的形状。
柔性电路中的至少一些的能量治疗部位可关于彼此沿纵向和沿周向偏离。
能量治疗部位可均包括一对相邻的双极电极。
能量治疗部位还可均包括定位在成对相邻双极电极之间的温度传感器。
另一种示例性装置可包括长形导管、与导管相关联的可扩张球囊,以及沿可扩张球囊的表面沿纵向延伸的多个沿周向间隔开的柔性电路。各个柔性电路可包括至少一个电极。电极可关于彼此沿轴向和沿周向间隔开。柔性电路可粘合地装固于可扩张球囊,并且包括延伸穿过柔性电路的多个开口。开口可构造成增大柔性电路的柔性。
电极可为单极电极。
各个柔性电路可包括第一单极电极和第二单极电极。第一单极电极和第二单极电极可沿周向偏离。第一柔性电路的单极电极可关于相邻柔性电路的单极电极沿纵向偏离。
装置还可包括公用电极。公用电极可定位在可扩张球囊的表面上。
柔性电路的至少一些转角可为圆转角。
各个柔性电路可包括沿柔性电路纵向地延伸的至少一个导体迹线。
各个柔性电路可包括沿柔性电路纵向地延伸的两个离散的导体迹线。
另一种示例性装置可包括可扩张球囊,其包括外表面。多个离散柔性电路可沿可扩张球囊的外表面延伸。柔性电路中的至少一些可均包括两个或更多个单极电极。柔性电路中的一些的至少一些部分可定形为至少近似键合于至少一个相邻柔性电路的形状。
柔性电路可粘合地联结于球囊的外表面。
柔性电路可包括构造成增大电路的柔性的开口。
另一种示例性装置可包括可扩张球囊,其包括外表面。至少一个柔性电路可安装在可扩张球囊的外表面上。至少一个柔性电路可包括第一绝缘层。至少一个热感测装置可至少部分地定位在第一绝缘层内。传导层可设置在第一绝缘层上方,该第一绝缘层的至少一部分可电性地联接于热感测装置。第二绝缘层可设置在传导层之上。至少一个单极电极可与传导层相关联。
至少一个电极可定位在第二绝缘层之上,并且可通过第二绝缘层联接于传导层。
热感测装置可具有小于近似0.15mm的厚度。
至少一个单极电极可包括至少两个单极电极极板,并且其中热感测装置可定位在成对的单极电极极板之间。
热感测装置可关于单极电极定位,使得热感测装置构造成在装置与组织接触时测量代表单极电极和组织两者的温度。
热感测装置可或可不电性地联接于单极电极。
装置可构造成在10个大气压或更低的充胀压力下或在6个大气压或更低的充胀压力下完全充胀。
另一种示例性装置可包括可扩张的非顺应性球囊,其包括外表面。可扩张球囊可构造成在10个大气压或更低的充胀压力下完全充胀。多个薄膜柔性电路可沿球囊的外表面沿纵向延伸。柔性电路中的至少一个可包括面对球囊的外表面的第一绝缘层、至少一个热感测装置、第一绝缘层之上的传导层、传导层之上的第二绝缘层,以及与传导层相关联的至少一个电极。柔性电路的最大厚度可小于0.2mm。
柔性电路的最大厚度可等于第一绝缘层、热感测装置、传导层、第二绝缘层和电极的厚度的和。
至少一个电极可为单极电极。
热感测装置可至少部分地定位在第一绝缘层内。
热感测装置的厚度可小于0.15mm。
球囊可构造成在6个大气压或更低的充胀压力下完全充胀。
一种示例性电极极板可包括具有底座开口的底座绝缘层。热感测构件可定位在底座开口内,并且可具有第一极和第二极。传导层可在底座绝缘层的顶部上。传导层可包括连接于第一极的第一迹线、连接于第二极的第二迹线,以及第三迹线。顶部绝缘层可层合在传导层的顶部上。顶部绝缘层可具有第一迹线之上的多个第一开口和第二迹线之上的多个第二开口。多个第一电极可层合在顶部绝缘层的顶部上,并且可经由顶部绝缘层中的多个第一开口传导地联接于第一迹线。多个第二电极可层合在顶部绝缘层的顶部上,并且可经由多个第二开口传导地联接于第二迹线。
底座绝缘层可具有沿侧向方向和纵向方向延伸的矩形形状。矩形形状可过渡至沿纵向方向延伸的窄延伸部。
第一迹线可包括沿纵向方向延伸的第一长形电极迹线。
第一迹线还可包括从第一长形迹线沿侧向移位的第一接地极板。接地极板可电子地联接于热感测构件。
第三迹线可包括联接于热感测构件的功率极板。
第一长形电极迹线和接地极板中的各个的远侧部分可由桥接部分连接。
多个第一电极中的各个可沿纵向方向伸长。
第二迹线可包括沿纵向方向延伸的第二长形电极迹线。
第二长形电极迹线可大致平行于第一长形电极迹线。
底座绝缘层和顶部绝缘层可均包括柔性聚合物。柔性聚合物可包括聚酰亚胺。聚酰亚胺可为近似0.0013mm厚。
顶部绝缘层可相对于传导层的上表面离散地定形。
顶部绝缘层可在形状上大致匹配底部绝缘层。
热感测元件可包括热敏电阻。热敏电阻可为近似0.10mm厚。
多个第一电极的表面面积可大致等于多个第二电极的表面面积。
多个第一电极和多个第二电极可包括金。
一种示例性电极组件可包括底座绝缘层,其包括远侧电极极板、中间尾部、近侧电极极板。底座绝缘层可具有热敏电阻开口。底座层可为矩形,并且沿纵向方向和侧向方向延伸。热敏电阻可定位在热敏电阻开口内,并且可具有接地极和功率极。传导层可层合在底座绝缘层的顶部上。传导层可包括连接于第一极的接地迹线、连接于第二极的第二迹线,以及第三迹线。顶部绝缘层可层合在传导层的顶部上。顶部绝缘层可具有第一迹线之上的多个第一开口和第二迹线之上的多个第二开口。多个第一电极可层合在顶部绝缘层的顶部上,并且可经由顶部绝缘层中的多个第一开口传导地联接于第一迹线。多个第二电极可层合在顶部绝缘层的顶部上,并且可经由多个第二开口传导地联接于第二迹线。
一种示例性柔性电路组件可包括远侧电极极板。远侧电极极板可包括具有远侧热敏电阻开口的远侧底座绝缘层、定位在远侧热敏电阻开口内并且具有第一远侧极和第二远侧极的远侧热敏电阻、层合在远侧底座绝缘层的顶部上的远侧传导层,远侧传导层包括沿接地轴线线性地延伸并且联接于第一远侧传感器极的远侧接地迹线、连接于第二远侧极的远侧传感器迹线,以及远侧有效电极迹线、层合在远侧传导层的顶部上的远侧顶部绝缘层,远侧顶部绝缘层具有第一远侧迹线之上的多个第一远侧开口和第二远侧迹线之上的多个第二远侧开口、多个第一远侧电极,其沿接地轴线延伸并且层合在远侧顶部绝缘层上,并且经由远侧顶部绝缘层中的多个第一远侧开口传导地联接于远侧接地迹线,以及多个第二远侧电极,其层合在远侧顶部绝缘层的顶部上并且在接地轴线的第一侧向侧上从多个第一远侧电极沿侧向移位,并且经由多个第二远侧开口传导地联接于远侧有效电极迹线。中间尾部可从远侧电极极板向近侧延伸。中间尾部可包括从远侧底座绝缘层延伸的中间底座绝缘层,以及层合在中间绝缘层的顶部上的中间传导层。中间传导层可包括从远侧接地迹线沿接地轴线延伸的中间接地线、联接于远侧有效电极迹线并且在接地轴线的第一侧向侧上沿平行于接地轴线的第一外轴线延伸的中间有效电极线,以及联接于远侧传感器迹线并且在接地轴线的第一侧向侧上沿平行于接地轴线且在接地轴线与第一外轴线之间的第一内轴线延伸的中间传感器线。中间顶部绝缘层可层合在中间传导层的顶部上。近侧电极极板可联接于中间延伸部件。近侧电极极板可包括具有近侧热敏电阻开口的近侧底座绝缘层、定位在近侧热敏电阻开口内并且具有第一近侧极和第二近侧极的近侧热敏电阻,以及层合在远侧底座绝缘层的顶部上的近侧传导层。近侧传导层可包括沿接地轴线线性地延伸并且联接于第一近侧传感器极的近侧接地迹线、联接于第二远侧极的远侧传感器迹线,以及近侧有效电极迹线。近侧顶部绝缘层可层合在近侧传导层的顶部上。近侧顶部绝缘层可具有第一近侧远侧迹线之上的多个第一近侧开口,以及第二近侧迹线之上的多个第二近侧开口。多个近侧远侧电极可沿接地轴线延伸,并且层合在近侧顶部绝缘层的顶部上,并且经由近侧顶部绝缘层中的多个第一近侧开口传导地联接于近侧接地迹线。多个第二近侧电极可层合在近侧顶部绝缘层的顶部上,并且在接地轴线的第二侧向侧上从多个第一近侧电极沿侧向移位,并且经由多个第二近侧开口传导地联接于近侧有效电极迹线。近侧腿部可从近侧电极极板向近侧延伸。近侧尾部可包括从近侧底座绝缘层延伸的近侧绝缘层,以及层合在近侧绝缘层的顶部上的近侧传导层。近侧传导层可包括从近侧接地迹线沿接地轴线延伸的近侧接地线、联接于远侧有效电极迹线并且在接地轴线的第二侧向侧上沿平行于接地轴线的第二外轴线延伸的近侧有效电极线、联接于近侧传感器迹线并且在接地轴线的第二侧向侧上沿平行于接地轴线且在接地轴线与第二外轴线之间的第二内轴线延伸的近侧传感器线、中间有效电极线,以及中间传感器线。近侧顶部绝缘层可层合在近侧传导层的顶部上。
另一种示例性装置可包括可扩张球囊,其包括外表面,以及安装在可扩张球囊的外表面上的至少一个柔性电路。至少一个柔性电路可包括第一绝缘层、至少部分地定位在第一绝缘层内的至少一个热感测装置、第一绝缘层之上的传导层,其至少一部分电性地联接于热感测装置、传导层之上的第二绝缘层,以及与传导层相关联的至少一个电极。
至少一个电极可定位在第二绝缘层之上,并且可通过第二绝缘层联接于传导层。
热感测装置可具有小于近似0.15mm的厚度。例如,热感测装置可具有近似0.1mm的厚度。
至少一个电极可为一对双极电极。
热感测装置可定位在成对双极电极之间。
热感测装置可关于成对的双极电极定位,使得热感测装置构造成在装置与组织接触时测量代表双极电极和组织两者的温度。
热感测装置可电性地联接于成对双极电极中的一个。
成对双极电极可包括多个有效电极和多个接地电极。
多个有效电极可沿第一纵轴线布置,并且多个接地电极沿第二纵轴线布置,该第二纵轴线偏离并且大致平行于第一纵轴线。
热感测装置可关于至少一个电极定位,使得热感测装置可构造成在装置与组织接触时测量代表至少一个电极和组织两者的温度。
另一种示例性方法可包括一种用于治疗患有高血压的患者的方法。该方法可包括提供装置。装置可包括导管、联接于导管并且包括外表面的可扩张球囊,以及安装在可扩张球囊的外表面上的至少一个柔性电路。至少一个柔性电路可包括第一绝缘层、至少部分地定位在第一绝缘层内的至少一个热感测装置、第一绝缘层之上的传导层,其至少一部分电性地联接于热感测装置、传导层之上的第二绝缘层,以及与传导层相关联的至少一个电极。该方法还可包括使球囊在患者的肾动脉中扩张和驱动能量穿过至少一个电极,以便以疗法改变肾动脉近侧的至少一条神经,使得患者的高血压被缓解。
提供装置可包括提供具有至少一对双极电极和定位在一对双极电极之间的热感测装置的装置。
该方法还可包括使用热感测装置来测量代表至少一个电极和肾动脉壁两者的温度。
另一种示例性装置可包括导管、联接于导管并且包括外表面的可扩张球囊,以及安装在可扩张球囊的外表面上的至少一个柔性电路。至少一个柔性电路可包括第一绝缘层、至少部分地定位在第一绝缘层内的至少一个热感测装置、第一绝缘层之上的传导层,其至少一部分电性地联接于热感测装置、传导层之上的第二绝缘层,以及与传导层相关联的至少一个电极。
一种示例性导管可包括长形柔性导管本体。可扩张结构可与导管本体相关联,并且可包括可沿径向扩张的球囊和沿球囊的外表面延伸的多个柔性电路,各个柔性电路包括至少一个电极和至少一个温度传感器。可扩张结构可在处于扩张构造时具有小于4mm的外径。
可扩张结构的外径可在近似1mm到3mm之间。
球囊可为非插管的。
球囊的外表面的至少一部分可为柔性聚酰亚胺膜。柔性聚酰亚胺膜可限定多个柔性电路的底座绝缘层。
球囊的底座绝缘层的上表面可直接地接触柔性电路中的至少一个的传导层。
各个柔性电路可包括球囊的外表面附近的底座绝缘层。
一种用于具有在主动脉与肾脏之间延伸的主肾动脉和在主动脉与肾脏之间延伸的副肾动脉的患者的肾去神经的示例性系统可包括第一球囊导管和第二球囊导管,各个具有带小轮廓构造和大轮廓构造的球囊,其中多个柔性电路沿各个球囊的外表面延伸,各个柔性电路包括至少一个电极。球囊中的至少一个可具有外径小于4mm的大轮廓构造。电源可电性地联接于第一球囊导管和第二球囊导管的电极,并且可构造成以肾去神经能量来激励电极。
球囊中的一个可具有外径等于或大于4mm的大轮廓构造。
第一球囊和第二球囊可具有为不同外径尺寸的大轮廓构造。
系统可用于还具有在主动脉与第二肾脏之间延伸的第二肾动脉的患者的肾去神经。系统还可包括具有小轮廓构造和大轮廓构造的第三球囊导管,其中多个柔性电路沿第三球囊的外表面延伸,各个柔性电路包括至少一个电极;并且其中第三球囊导管的电极电性地联接于电源。
在处于大轮廓构造时,第一球囊、第二球囊和第三球囊可限定彼此不同的外径。在处于大轮廓构造时,第三球囊的外径可大于或等于4mm。
一种示例性肾去神经方法可包括将长形柔性导管本体的可沿径向扩张的结构定位在将主动脉连接于肾脏的副肾动脉中的位置处,主动脉和肾脏还由主肾动脉连接,可沿径向扩张结构包括多个电极;使可沿径向扩张结构扩张使得电极的至少一个子集接合副肾动脉壁;以及使用电性地联接于电极的电源激励多个电极的至少一个子集来将能量输送至副肾动脉近侧的组织。
该方法还可包括将可沿径向扩张结构定位在主肾动脉中的位置处、使沿径向结构扩张使得电极中的至少一些接合主肾动脉壁,以及激励电极中的至少一些以将能量输送至主肾动脉近侧的组织。
该方法还可包括将第二长形柔性导管本体的第二可沿径向扩张结构定位在主肾动脉中的位置处、使第二可沿径向扩张结构扩张使得第二可沿径向扩张结构的多个电极的至少一个子集接合主肾动脉壁,以及激励第二可沿径向扩张结构的电极的至少一个子集来将能量输送至主肾动脉近侧的组织。
激励电极可包括多个激励循环。激励电极的子集中的电极可在激励循环中的至少一些之间变化。电源的能量输出设置可在激励循环中的至少一些之间变化。
另一种示例性肾去神经方法可包括将长形柔性导管本体的可沿径向扩张结构定位在将主动脉连接于肾脏的肾动脉中。可沿径向扩张结构可包括多个电极。该方法还可包括使可沿径向扩张结构扩张使得电极的子集接合肾动脉壁。电极的另一个子集可在主动脉中。该方法还可包括使用电性地联接于电极的电源,激励与肾动脉壁接合的电极的子集中的至少一些。
另一种示例性肾去神经方法可包括将长形柔性导管本体的可沿径向扩张结构定位在将主动脉连接于肾脏的肾动脉中。可沿径向扩张结构可包括多个电极。该方法还可包括使可沿径向扩张结构扩张使得电极的至少一个子集接合肾动脉壁、使用电性地联接于电极的电源、激励与肾动脉壁接合的电极的子集中的至少一些、将可沿径向扩张结构重新定位于肾动脉中的第二位置、在第二位置处使可沿径向扩张结构扩张使得电极的子集接合肾动脉壁并且电极的不同子集在主动脉中,以及在第二位置处激励与肾动脉壁接合的电极的子集中的至少一些。
肾动脉可包括副肾动脉。主肾动脉也可将主动脉连接于肾脏。
一种用于可具有在主动脉与肾脏之间延伸的主肾动脉和在主动脉与肾脏之间延伸的副肾动脉的患者的肾去神经的示例性系统可包括第一球囊导管和第二球囊导管,各个具有带小轮廓构造和大轮廓构造的球囊,其中多个柔性电路沿各个球囊的外表面延伸,各个柔性电路包括至少一个电极。球囊中的至少一个可具有外径小于4mm的大轮廓构造。系统还可包括电源,其构造成电性地联接于第一球囊导管和第二球囊导管的柔性电路,并且构造成在不同时间以肾去神经能量激励第一球囊导管和第二球囊导管的电极。
球囊中的一个可具有外径等于或大于4mm的大轮廓构造。
第一球囊和第二球囊可具有为不同外径尺寸的大轮廓构造。
系统可用于还具有在主动脉与第二肾脏之间延伸的第二肾动脉的患者的肾去神经。系统还可包括具有小轮廓构造和大轮廓构造的第三球囊导管,其中多个柔性电路沿第三球囊的外表面延伸,各个柔性电路包括至少一个电极。第三球囊导管的电极可构造用于电性地联接于电源。
在处于大轮廓构造时,第一球囊、第二球囊和第三球囊可限定彼此不同的外径。
在处于大轮廓构造时,第三球囊的外径可大于或等于4mm。
一种示例性导管可包括长形柔性导管本体。可扩张结构可与导管本体相关联,并且包括可沿径向扩张的球囊和沿球囊的外表面延伸的多个柔性电路,各个柔性电路包括至少一个电极和至少一个温度传感器。可扩张结构可在处于扩张构造时具有小于4mm的外径。
可扩张结构的外径可在近似1mm到3mm之间。
球囊可为非插管的。
球囊的外表面的至少一部分可为柔性聚酰亚胺膜。
柔性聚酰亚胺膜可限定多个柔性电路的底座绝缘层。
球囊的底座绝缘层的上表面可直接地接触柔性电路中的至少一个的传导层。
各个柔性电路可包括球囊的外表面附近的底座绝缘层。
还公开了一种用于患者的肾去神经的示例性系统,该患者具有在主动脉与肾脏之间延伸的主肾动脉,以及在主动脉与肾脏之间延伸的副肾动脉。系统可包括第一球囊导管和第二球囊导管,各个具有带小轮廓构造和大轮廓构造的球囊,其中多个柔性电路沿各个球囊的外表面延伸,各个柔性电路包括至少一个电极,其中球囊中的至少一个具有外径小于4mm的大轮廓构造。电源可电性地联接于第一球囊导管和第二球囊导管的电极,并且可构造成以肾去神经能量来激励电极。
球囊中的一个可具有外径等于或大于4mm的大轮廓构造。
第一球囊和第二球囊可具有为不同外径尺寸的大轮廓构造。
系统可用于还具有在主动脉与第二肾脏之间延伸的第二肾动脉的患者的肾去神经。系统还可包括具有小轮廓构造和大轮廓构造的第三球囊导管,其中多个柔性电路沿第三球囊的外表面延伸,各个柔性电路包括至少一个电极;并且其中第三球囊导管的电极电性地联接于电源。
在处于大轮廓构造时,第一球囊、第二球囊和第三球囊可限定彼此不同的外径。
在处于大轮廓构造时,第三球囊的外径可大于或等于4mm。
一种示例性肾去神经方法可包括将长形柔性导管本体的可沿径向扩张结构定位在将主动脉连接于肾脏的副肾动脉中的位置处,主动脉和肾脏还由主肾动脉连接。可沿径向扩张结构可包括多个电极。该方法还可包括使可沿径向扩张结构扩张,使得电极的至少一个子集接合副肾动脉壁,并且使用电性地联接于电极的电源,激励多个电极的至少一个子集以将能量输送至副肾动脉近侧的组织。
该方法还可包括将可沿径向扩张结构定位在主肾动脉中的位置处、使沿径向结构扩张使得电极中的至少一些接合主肾动脉壁,并且激励电极中的至少一些以将能量输送至主肾动脉近侧的组织。
该方法还可将第二长形柔性导管本体的第二可沿径向扩张结构定位在主肾动脉中的位置处;使第二可沿径向扩张结构扩张,使得第二可沿径向扩张结构的多个电极的至少一个子集接合主肾动脉壁;并且激励第二可沿径向扩张结构的电极的至少一个子集以将能量输送至主肾动脉近侧的组织。
激励电极可包括多个激励循环。激励电极的子集中的电极可在激励循环中的至少一些之间变化。
电源的能量输出设置可在激励循环中的至少一些之间变化。
另一种示例性肾去神经方法可包括将长形柔性导管本体的沿径向扩张结构定位在将主动脉连接于肾脏的肾动脉中。可沿径向扩张结构可包括多个电极。该方法还可包括使可沿径向扩张结构扩张使得电极的子集接合肾动脉壁,其中电极的另一个子集在主动脉中,并且使用电性地联接于电极的电源,激励与肾动脉壁接合的电极的子集中的至少一些。
另一种示例性肾去神经方法可包括将长形柔性导管本体的可沿径向扩张结构定位在将主动脉连接于肾脏的肾动脉中。可沿径向扩张结构可包括多个电极。该方法还可包括使可沿径向扩张结构扩张使得电极的至少一个子集接合肾动脉壁,使用电性地联接于电极的电源,激励与肾动脉壁接合的电极的子集中的至少一些,将可沿径向扩张结构重新定位于肾动脉中的第二位置,在第二位置处使可沿径向扩张结构扩张使得电极的子集接合肾动脉壁,并且电极的不同子集在主动脉中,以及在第二位置处激励与肾动脉壁接合的电极的子集中的至少一些。
肾动脉可包括副肾动脉。主肾动脉也可将主动脉连接于肾脏。
还公开了另一种用于患者的肾去神经的示例性系统,该患者具有在主动脉与肾脏之间延伸的主肾动脉,以及在主动脉与肾脏之间延伸的副肾动脉。系统可包括第一球囊导管和第二球囊导管,各个具有带小轮廓构造和大轮廓构造的球囊,其中多个柔性电路沿各个球囊的外表面延伸,各个柔性电路包括至少一个电极。球囊中的至少一个可具有外径小于4mm的大轮廓构造。该系统还可包括电源,其构造成电性地联接于第一球囊导管和第二球囊导管的柔性电路,并且构造成在不同时间以肾去神经能量激励第一球囊导管和第二球囊导管的电极。
球囊中的一个可具有外径等于或大于4mm的大轮廓构造。
第一球囊和第二球囊可具有为不同外径尺寸的大轮廓构造。
系统可用于还具有在主动脉与第二肾脏之间延伸的第二肾动脉的患者的肾去神经。系统还可包括具有小轮廓构造和大轮廓构造的第三球囊导管,其中多个柔性电路沿第三球囊的外表面延伸,各个柔性电路包括至少一个电极。第三球囊导管的电极可构造用于电性地联接于电源。
在处于大轮廓构造时,第一球囊、第二球囊和第三球囊可限定彼此不同的外径。
在处于大轮廓构造时,第三球囊的外径可大于或等于4mm。
还公开了一种用于使用设备治疗身体通路附近的组织的示例性方法,该设备包括具有多个电极的导管、射频能量发生器,以及将能量发生器联接于多个电极并且构造成有选择地激励电极的控制器。该方法可包括使用设备来使身体通路附近的组织经受多个能量治疗循环。治疗循环可包括确定电极的至少一个子集的期望电压用于保持电极子集近侧的预定目标温度曲线、将能量发生器的输出电压设置成对应于确定用于电极中的一个的期望电极,以及在输出电压下激励电极中的至少一些以将能量输送至身体通路。用于设置输出电压的电极可在至少一些情况下在随后的处理循环中变化。
治疗循环还可包括识别第一电极。如果第一电极的确定的电压要求大于零,则第一电极可用于设置输出电压。
第一电极的识别可通过多个电极从治疗循环到治疗循环来循环。
治疗循环还可包括识别在第一电极近侧引起泄漏的至少一个电极。在第一电极近侧引起泄漏的至少一个电极可在治疗循环不受激励。
多个电极可包括多个双极电极,并且其中识别在第一电极近侧引起泄漏的至少一个电极可包括识别具有在第一电极的阳极近侧引起泄漏的阴极的至少一个电极。
确定电极子集中的电极的期望电压可基于施加于电极子集中的电极的之前的输出电压。
确定电极子集中的电极的期望电压还可基于电极子集中的电极近侧的测量温度与目标温度之间的差异。
确定电极子集中的电极的期望电压可基于电极子集中的电极的当前温度误差以及在一定时间内的平均温度误差。
期望电压可等于:
其中V为期望电压,VL为之前计算的输出电压,Te为电极子集中的电极的温度误差,KL、KP和KI为常数,并且n为范围从0到t秒的时间值。
期望电压可等于:
其中V为期望电压,VL为之前计算的输出电压,Te为电极子集中的电极的温度误差,并且KP和KI为常数。
还公开了一种用于使用设备治疗身体通路的示例性方法,该设备包括具有多个离散的能量输送部位的能量输送装置、能量发生器,以及将能量输送部位联接于能量发生器并且构造成有选择地激励多个能量输送部位的控制器。该方法可包括使用设备来使身体通路经受多个治疗循环。治疗循环中的至少一些可包括确定能量输送部位的至少一个子集的多个可能的输出水平用于保持治疗的预定参数、将能量发生器的实际输出水平设置成对应于确定用于能量输送部位中的一个的可能输出水平,以及在实际输出水平下激励能量输送部位中的至少一些以将能量输送至身体通路。能量输送部位可用于在至少一些情况下设置从治疗循环到治疗循环的实际输出水平变化。
确定多个可能的输出水平可包括确定多个可能的激励时间。
确定多个可能的输出水平可包括确定多个可能的输出电压。
在实际输出水平下激励能量输送部位中的至少一些可包括激励与可能的输出水平相关联的能量输送部位中的至少一些,该可能的输出水平等于或大于在治疗循环期间设置的实际输出水平。
确定能量输送部位中的一个的可能输出水平可基于在紧接之前的治疗循环中施加在能量输送部位处的输出水平。
确定能量输送部位中的一个的可能输出水平还可基于能量输送部位近侧的实际状态与预定参数之间的误差的特性。
治疗循环中的至少一些还可包括从多个能量输送部位识别第一能量输送部位。
识别第一能量输送部位可通过多个能量输送部位从治疗循环到治疗循环来循环。
如果确定用于第一能量输送部位的可能输出水平大于零,则确定用于第一能量输送部位的可能的输出水平可用于设置实际输出水平。
第一能量输送部位近侧的能量输送部位中的至少一些可在治疗循环期间不受激励。
还公开了一种用于使用电外科系统引起组织中的期望疗法变化的示例性方法。该方法可包括将系统的多个电极电性地联接于组织的多个区,以及以多个加热循环来加热组织。各个加热循环可具有相关联的选择区,并且可包括响应于期望特性确定选择区的期望电势、确定适于施加期望电势的一组电极,以及以期望电势激励选择的一组电极。该方法还可包括监测来自区的温度信号,并且同时通过交换区之间的选择区和通过响应于温度信号识别期望变化和一组电极来引起区的组织中的期望疗法变化。
组织可设置在身体通路附近。多个电极可通过使可扩张本体在通路内扩张来与区联接。电极可包括由可扩张本体支承的双极电极。期望的电势可包括双极电势。
一种用于治疗身体通路附近的组织的示例性系统可包括具有多个电极的导管、射频能量发生器,以及将能量发生器联接于多个电极并且构造成在多个能量治疗循环期间有选择地激励电极的控制器。在治疗循环期间,系统可构造成确定电极的至少一个子集的期望电压用于保持电极子集近侧的预定目标温度、将能量发生器的输出电压设置成对应于确定用于电极中的一个的期望电压,以及在输出电压下激励电极中的至少一些以将能量输送至身体通路近侧;并且其中系统构造成在至少一些情况下从治疗循环到治疗循环改变用于设置输出电压的电极。
一种示例性能量发生设备可包括射频能量发生器和控制器。控制器可构造成将能量发生器联接于具有多个电极的导管。控制器可构造成在多个能量治疗循环期间有选择地激励电极,包括确定电极的至少一个子集的期望电压用于保持电极子集近侧的预定目标温度、将能量发生器的输出电压设置成对应于确定用于电极中的一个的期望电压,以及在设置的输出电压下激励电极中的至少一些以将能量输送至身体通路。控制器可构造成在至少一些情况下从治疗循环到治疗循环改变用于设置输出电压的电极。
还公开了一种用于使用设备治疗身体通路的示例性方法,该设备包括具有多个离散的能量输送部位的能量输送装置、能量发生器,以及将能量输送部位联接于能量发生器并且构造成有选择地激励多个能量输送部位的控制器。该方法可包括使用设备来使身体通路经受多个治疗循环。治疗循环中的至少一些可包括选择能量输送部位中的一个作为主能量输送部位、识别不在主能量输送部位近侧引起能量泄漏的能量输送部位的至少一个子集,以及激励能量输送部位的子集中的至少一些。在主能量输送部位在至少一些情况下从治疗循环到治疗循环变化时,可选择能量输送部位。
还公开了一种用于使用设备治疗身体通路附近的组织的示例性方法,该设备具有多个电极、能量发生器,以及将能量发生器联接于多个电极并且构造成有选择地激励电极的控制器。该方法可包括使用设备来使身体通路附近的组织经受多个能量治疗循环。治疗循环可包括确定电极的至少一个子集的期望功率设置用于保持电极子集近侧的预定目标温度曲线、将能量发生器的实际功率设置设置成对应于确定用于电极中的一个的期望功率设置,以及在实际功率设置下激励电极中的至少一些以将能量输送至身体通路。电极可用于在至少一些情况下设置随后的治疗循环中的实际功率设置变化。
还公开了一种用于将基于能量的治疗输送至血管近侧的组织的示例性方法。该方法可包括将长形柔性导管本体的可沿径向扩张结构定位在血管中的位置处,多个电极定位在可沿径向扩张结构上;使可沿径向扩张结构扩张使得电极的至少一个子集接合血管壁,以便建立多个电路,各个电路包括电极中的一个和治疗区内的组织的一部分;使用电源以时间顺序激励多个电路;以及使用与电源联接的处理器控制能量输送,此类控制包括验证电路的存在,在该顺序期间有选择地激励电极,以及调节电路的一个或更多个参数,使得输送到治疗区的能量将其中的组织加热至目标温度范围中的温度,从而引起组织重建反应。
电极可通过识别适合的电极组并且同时在该顺序期间激励电极组,以及通过经由该顺序重复地循环来有选择地激励。组可响应于与治疗区内的组织部分相关联的多个温度信号来确定,以使组随循环变化。
电极可包括定位在球囊上并且包括在多个柔性电路中的单极电极,各个柔性电路均包括单极电极中的至少一个。
多个柔性电路还可包括邻近单极电极中的至少一个的温度感测结构,温度感测结构电性地联接于处理器以便提供反馈。
球囊可利用大约5个大气压或更低的充胀压力充胀。
可扩张结构的扩张直径可为大约2mm到大约10mm。例如,可扩张结构的扩张直径可为大约3mm或更小。
还公开了一种用于将基于能量的治疗输送至血管近侧的组织的示例性方法。该方法可包括将长形导管的可扩张结构定位在血管中的位置处,可扩张结构包括多个电极,其中至少一些沿可扩张结构沿纵向间隔,多个电极电性地联接于电源;使可扩张结构扩张使得多个电极中的至少一些接触组织;使用与电源联接的处理器,验证多个电极中的哪个与组织接触;有选择地激励与组织接触的电极中的至少一个;以及使用处理器控制能量输送以基于来自与电极中的至少一些相关联的电路的监测反馈调节能量治疗的一个或更多个参数,使得输送至治疗区的能量加热其中的组织。
验证电极中的一个是否与组织接触可包括测量与电极相关联的电路的特性和确定测量的特性是否满足标准。
有选择地激励至少一个电极可包括激励满足标准的电极并且不激励不满足标准的电极。
测量电路的特性可包括测量与电路相关联的电阻。
有选择地激励至少一个电极可包括仅激励与在预定范围内的测量电阻相关联的电极。
定位包括多个电极的可扩张结构可包括定位包括多个单极电极的可扩张结构。
定位可扩张结构包括定位包括多个单极电极和公用电极的可扩张结构。
确定测量特性是否满足标准可包括确定与第一单极电极相关联的测量特性是否满足第一标准,以及确定与第二单极电极相关联的测量特性是否满足第二标准。第一标准和第二标准可不同。
确定测量特性是否满足标准可包括确定与第一单极电极相关联的测量特性和与第二单极电极相关联的测量特性是否满足单个标准。
还公开了一种用于将基于能量的治疗输送至血管近侧的组织的示例性系统。系统可包括长形导管,其包括导管的远端处或附近的可扩张结构。可扩张结构可包括多个电极,其中至少一些沿可扩张结构纵向地间隔开。系统还可包括电性地联接于多个电极的电源,以及处理器,该处理器构造成通过测量与多个电极中的至少一些相关联的电路的特性和确定测量特性是否满足标准来验证多个电极中的至少一些是否与组织接触。如果多个电极中的至少一个验证为与组织接触,则处理器可构造成激励多个电极中的至少一个。处理器可构造成控制能量输送以基于来自电路中的至少一些的监测反馈来调节能量治疗的一个或更多个参数,使得输送至治疗区的能量将其中的组织加热至大约55℃到大约75℃的温度,同时附属于治疗区的组织加热至小于大约45℃。
可扩张结构的多个电极可为多个单极电极。
可扩张结构还可包括至少一个公用电极。
长形导管还可包括至少一个公用电极。
系统还可包括至少一个公用电极极板。
还公开了一种用于将基于能量的治疗输送至血管近侧的组织的示例性方法。该方法可包括使用长形导管将基于能量的治疗系统的可扩张结构定位在血管中的位置处,可扩张结构定位在导管的远端处或附近,并且包括多个单极电极。基于能量的治疗系统还可包括公用电极和电源,电源电性地联接于多个单极电极。该方法还可包括使可扩张结构扩张,使得多个电极中的至少一些接触组织;使用处理器测量多个电路的特性,各个电路与多个单极电极中的一个和公用电极相关联;使用处理器识别单极电极的子集用于激励,识别的电极子集具有在期望范围内的测量特性;以及同时激励识别用于激励的单极电极中的一个或更多个。
公用电极可与可扩张结构相关联。
另一种用于将基于能量的治疗输送至血管近侧的组织的示例性方法可包括将长形导管的可扩张结构定位在血管中的位置处,可扩张结构定位在导管的远端处或附近并且包括多个单极电极,其中至少一些沿可扩张结构纵向地间隔,多个电极电性地联接于电源;使可扩张结构扩张使得多个电极中的至少一些接触组织;有选择地激励多个电极的子集;以及使用处理器控制能量输送以基于来自与电极中的至少一些相关联的电路的监测反馈来调节能量治疗的一个或更多个参数,使得输送至治疗区的能量将其中的组织加热至期望范围中的温度。
该方法还可包括在有选择地激励多个电极的子集之前使用处理器识别用于激励的电极的子集。
识别电极的子集可包括测量与多个电极中的各个相关联的电路的特性。
识别电极的子集还可包括使用处理器比较测量的特性以识别用于激励的子集。
识别用于激励的子集可包括识别具有大致类似的测量特性的电极组。
识别电极的子集还可包括确定与多个电极中的各个相关联的测量特性是否满足预定要求。
确定与多个电极中的各个相关联的测量特性是否满足预定要求可包括确定与多个电极中的各个相关联的测量特性是否在预定范围内。
确定与多个电极中的各个相关联的测量特性是否在预定范围内可包括使用相同预定范围来用于电极中的各个。
确定与多个电极中的各个相关联的测量特性是否在预定范围内可包括使用不同预定范围来用于电极中的至少一些。
还公开了一种用于使用设备治疗身体通路附近的组织的示例性方法,该设备包括具有多个单极电极的导管、射频能量发生器,以及将能量发生器联接于单极电极并且构造成有选择地激励单极电极的控制器。该方法可包括使用设备来使身体通路附近的组织经受多个能量治疗循环。治疗循环可包括确定单极电极的至少一个子集的期望电压用于确定单极电极的子集近侧的预定目标温度曲线;将能量发生器的输出电压设置成对应于确定用于单极电极中的一个的期望电压;以及在输出电压下激励单极电极中的至少一个以将能量输送至身体通路。单极电极可用于在至少一些情况下在随后的治疗循环中设置输出电压变化。
治疗循环还可包括识别第一单极电极;其中如果用于第一单极电极的确定电压要求大于零,则第一单极电极用于设置输出电压。
第一单极电极的识别可通过多个单极电极从治疗循环到治疗循环来循环。
治疗循环还可包括识别与电路特性相关联的至少一个单极电极,该电路特性大致不同于与第一单极电极相关联的电路特性。与大致不同的电路特性相关联的至少一个单极电极可在治疗循环期间不被激励。
用于识别的电路特性可为阻抗测量。
还公开了一种用于使用设备治疗身体通路的示例性方法,该设备包括具有多个离散单极能量输送部位、公用电极的能量输送装置、能量发生器,以及将单极能量输送部位联接于能量发生器并且构造成有选择地激励多个单极能量输送部位的控制器。该方法可包括使用设备来使身体通路经受多个治疗循环。治疗循环中的至少一些可包括确定单极能量输送部位的至少一个子集的多个可能的输出水平用于保持治疗的预定参数;将能量发生器的实际输出水平设置成对应于确定用于单极能量输送部位中的一个的可能的输出水平;以及在实际输出水平下激励单极能量输送部位中的至少一些以将能量输送至身体通路。用于设置实际输出水平的单极能量输送部位可在至少一些情况下从治疗循环到治疗循环变化。
还公开了一种用于治疗患有充血性心力衰竭的患者的方法。该方法可包括将可扩张球囊定位在患者的肾动脉中,可扩张球囊包括多个电极组件,电极组件中的至少一些均包括至少两个双极电极对,两个双极电极对沿纵向和沿周向偏离彼此;使球囊在肾动脉中扩张使得双极电极对中的至少一些电性地联接于肾动脉壁;以及激励双极电极对中的至少一些以便以疗法改变肾动脉近侧的至少一条神经来治疗患者的充血性心力衰竭。
激励双极电极对中的至少一些可包括使用多个温度传感器来调整双极电极对的能量输出,各个传感器定位在双极电极对中的一个之间。
将可扩张球囊定位在患者的肾动脉中可包括定位可扩张球囊,其中电极组件的双极电极对沿纵向偏离沿周向相邻的双极电极对。
另一种用于治疗患有充血性心力衰竭的患者的示例性方法可包括将包括能量输送结构阵列的可扩张装置定位在患者的肾动脉中;使可扩张装置扩张使得能量输送结构中的至少一些邻近肾动脉壁;以及激励能量输送结构中的至少一些以便以疗法改变肾动脉近侧的至少一条神经来治疗患者的充血性心力衰竭。
能量输送结构可在治疗期间被激励小于十分钟,或者能量输送结构可在治疗期间被激励小于五分钟,或者能量输送结构可在治疗期间被激励小于一分钟。
能量输送结构可被激励,其中,可扩张装置在治疗期间在患者的肾动脉中的仅一个位置处。
一种治疗充血性心力衰竭的示例性方法可包括使患者的肾组织经受射频能量小于十分钟,使得治疗将患者中的降肾上腺素浓度有效地减小超过50%,以便治疗患者的充血性心力衰竭。
治疗可将肾组织近侧的降肾上腺素浓度有效降低超过50%。
使肾组织经受射频能量小于十分钟可包括使肾组织经受射频能量小于五分钟。
使肾组织经受射频能量小于五分钟包括使肾组织经受射频能量小于一分钟。
使肾组织经受射频能量可包括将肾组织近侧的温度升高至近似在50℃到80℃的范围内的温度。
将温度升高至近似在50℃到80℃的范围中的温度可包括将温度升高至近似在55℃到75℃的范围中的温度。将温度升高至近似在55℃到75℃的范围中的温度可包括将温度升高至近似68℃的目标温度。
将温度升高至68℃的目标温度还可包括升高温度使得温度变化速率随着温度接近目标温度而逐渐减小。
升高温度使得温度变化速率随着温度接近目标温度而逐渐减小可包括升高温度使得温度变化速率随着温度接近目标温度而线性地减小。
使肾组织经受射频能量可包括将包括多个电极的导管插入到肾动脉中,使得电极定位在肾组织近侧,以及有选择地激励多个电极。
充血性心力衰竭可为心脏收缩充血性心力衰竭。
充血性心力衰竭可为心脏舒张充血性心力衰竭。
一种示例性肾去神经治疗方法可包括使用肾去神经导管系统的导管组件将RF能量治疗输送至肾动脉近侧的组织。去神经系统可包括由控制器与导管组件联接的RF能量发生器。该方法还可包括使用导管组件将肾活动刺激施加于肾动脉近侧的组织;使用导管组件评估组织的刺激神经活动反应;以及基于评估的神经活动来确定RF能量治疗的参数。
该方法还可包括输出关于评估的神经活动的数据。
输出数据可包括输出神经活动的充分减少是否发生。
评估神经活动可包括进行至少第一神经活动测量和第二神经活动测量。
进行第一神经活动测量可包括在开始RF能量治疗的输送之前进行第一神经活动测量以形成基准神经活动测量。进行第二神经活动测量可包括在开始RF能量治疗的输送之后进行第二神经活动测量。该方法还可包括确定神经活动是否从基准变化。
确定神经活动是否从基准变化可包括确定神经活动的变化是否处于、高于或低于阈值。
该方法还可包括一旦神经活动的变化处于或高于阈值,则终止RF能量治疗。
感测刺激神经活动反应可包括在RF能量治疗期间周期地测量刺激神经活动反应。
施加神经活动刺激可包括激励导管组件的至少一个电极。评估刺激神经活动反应可包括使用导管组件的第二电极来监测神经响应信号。
输送RF能量治疗可包括使用至少一个电极和第二电极来将RF能量输送至组织。
输送RF能量治疗可包括使用导管组件,该导管组件具有在可扩张装置的近端处的至少一个电极和在装置的远端处的第二电极。
输送RF能量治疗可包括使用导管组件,该导管组件具有为关于彼此沿侧向和沿周向偏离中的至少一个的至少一个电极和第二电极。
输送RF能量治疗可包括使用除至少一个电极和第二电极之外的多个电极。
监测神经响应信号可包括测量神经响应信号的振幅、测量神经刺激信号与神经响应信号之间的时间延迟,以及测量神经响应信号的分级振幅中的至少一个。
该方法还可包括测量神经响应信号的振幅、神经响应信号的脉宽、神经响应信号的斜率或斜率变化、神经响应信号的速度或神经响应信号的时间延迟中的至少一个。
该方法还可包括将测量结果与早先的神经响应信号的基准测量结果相比较。
确定RF能量治疗的至少一个参数可包括基于评估的神经活动调整至少一个参数。
调整至少一个参数可包括调整RF能量治疗的温度曲线。
调整至少一个参数可包括调整目标温度曲线的目标温度下的时间长度。
调整至少一个参数可包括调整RF能量发生器的电压设置。
调整至少一个参数可包括调整电压设置同时保持目标温度恒定。
该方法还可包括如果评估的神经活动不低于阈值水平,则在预定时间段之后终止RF能量治疗。
该方法还可包括重新定位导管组件和将第二RF能量治疗输送至肾动脉近侧的第二组织部分。
确定RF能量治疗的参数还可包括基于评估的神经活动和组织的温度测量来确定RF能量治疗的参数。
另一种示例性肾去神经方法可包括将第一神经活动刺激施加于肾去神经系统的导管组件近侧的组织;使用导管组件测量组织的第一刺激神经活动反应;使用导管组件将能量治疗输送至肾动脉近侧的组织;使用导管组件测量神经组织的第二神经活动反应;以及通过比较第一测量神经活动和第二测量神经活动来确定能量治疗的参数。
比较第一测量神经活动和第二测量神经活动可包括比较第一神经活动和第二神经活动的信号振幅中的至少一个、与第一神经活动和第二神经活动相关联的时间延迟、第一神经活动和第二神经活动的脉宽、第一神经活动和第二神经活动的速度,以及第一神经活动和第二神经活动的斜率或斜率变化。
另一种示例性去神经方法可包括使用植入装置将能量治疗输送至身体管腔近侧的组织;使用植入装置评估组织的神经活动;以及使用评估的神经活动至少部分地确定能量治疗的至少一个参数。
另一种示例性肾去神经治疗方法可包括将基于导管的组件定位在身体组织近侧的肾动脉中;使用基于导管的组件将能量治疗输送至身体组织;在能量治疗期间或之后,评估身体组织的神经活动水平是否降低;以及在神经活动水平充分下降之后从肾动脉除去基于导管的组件。
治疗可将患者中的降肾上腺素浓度有效地降低超过50%。
治疗可将肾动脉近侧的身体组织中的降肾上腺素浓度有效地降低超过50%。
治疗可将患者的心脏收缩血压有效地降低至少5%,或至少10%,或至少20%。
治疗可将患者的心脏舒张血压有效地降低至少5%,或至少10%,或至少20%。
一种示例性肾去神经治疗系统可包括长形导管,其包括在导管远端处或附近的可扩张结构。可扩张结构可包括多个电极。电源可电性地联接于多个电极。系统还可包括处理器,其构造成在肾去神经能量水平下激励电极的至少一个子集、在神经活动刺激水平下激励电极中的一个或更多个,以及使用电极中的一个或更多个监测神经活动反应。
神经活动刺激水平可为在大约0.1V到大约5V的范围中的电压施加大约1秒或更短。例如,神经活动刺激水平可为大约0.5V施加大约0.5毫秒。
一些实施例的以上概述并不旨在描述本公开的各个公开的实施例或每个实施方式。附图和之后的详细描述更具体地例示了这些实施例。
附图说明
图1A示出了用于重建组织的示例性系统的简化示意图。
图1B为导管的示例性可扩张装置的透视图。
图1C为处于展开构造的图1B的可扩张装置的俯视图。
图1D和图1E为示例性可扩张装置的透视图。
图1F为示例性可扩张装置的透视图。
图2A为示例性电极组件的俯视图。
图2B为图2A的局部截面视图A-A。
图2C为图2A的局部截面视图B-B。
图3A-3D为具有多个电极极板的各种示例性电极组件的俯视图。
图4A-4C为具有单个远侧电极极板的各种示例性电极组件的俯视图。
图5A-5F为具有单个近侧电极极板的各种示例性电极组件的俯视图。
图5G-I为各种示例性单极电极组件的俯视图。
图6为用于重建身体通路的图1A的系统的截面图。
图7-10示出了温度曲线的各种非限制性实例。
图11和图12通过比较温度曲线的某些非限制性实例示出了实验结果。
图13和图14示出了控制环的一个实施例。
图13A示出了控制环的另一个实施例。
图15示出了电极在一定时间内的温度变化的一个非限制性实例。
图16-23示出了在治疗期间与八个电极相关联的各种性质的一个非限制性实例。
图24A-24F为从治疗的一个实施例的示例性屏幕截图。
图25-30示出了评估用于肾去神经的示例性系统的效力和安全性的一个实验。
图31和图32示意性地示出了与两个电极相关联的示例性治疗区。
图33示出了包括定位在身体通路中的电极阵列的可扩张球囊。
图34-38示出了尤其评估在肾动脉近侧的组织中由电外科程序产生的治疗区的范围的实验。
图39-41示出了RF治疗的过程期间的重叠治疗区的实例。
图42和图43示意性地示出了包括用于刺激和测量神经信号的电极的导管的(多个)可扩张装置。
图44和图45分别示出了治疗之前和接受至少一些治疗之后的神经响应信号。
图46示出了可扩张球囊的实施例。
图47-50B示出了肾去神经治疗的方法的实施例。
具体实施方式
对于以下限定的用语,将应用这些定义,除非不同的定义在权利要求中或在本说明书的别处给出。
所有数值在本文中假定为通过用语"大约"修饰,而不论是否明确地指示。用语"大约"大体上表示本领域的技术人员将认为等同于叙述的值(即,具有相同功能或结果)的数字范围。在许多情况下,用语"大约"可包括四舍五入至最接近的有效数的数字。
由端点的数字范围的叙述包括在该范围内的所有数字(例如,1到5包括1、1.5、2、2.75、3、3.80、4和5)。
如本说明书和所附权利要求中使用的,单数形式"一"、"一个"和"该"包括复数对象,除非内容另外清楚地指示。如本说明书和所附权利要求中使用的,用语"或"大体上以其包括"和/或"的意义使用,除非内容另外清楚地指示。
注意的是,说明书中提到"实施例"、"一些实施例"、"其它实施例"等指示了所述实施例可包括一个或更多个特定特征、结构和/或特性。然而,此类叙述不一定意指所有实施例包括特定特征、结构和/或特性。此外,当特定特征、结构和/或特性结合一个实施描述时,应当理解的是,此类特征、结构和/或特性还可结合其它实施例使用,而不论是否明确地描述,除非清楚地相反陈述。
以下详细描述应当参照附图来阅读,其中不同图中的相似元件相同地标记。不必按比例的附图绘出了示范性实施例,并且不旨在限制本发明的范围。
医生使用导管来进入并且通过改进身体的内部组织来影响疗法,特别是在身体管腔(诸如血管)内或周围。例如,球囊血管成形术和其它导管通常用于开启已经由于动脉粥样硬化疾病而变窄的动脉。
导管可用于通过RF能量治疗来在患有难治疗的高血压的患者中执行肾去神经。这是相对新的程序,已经发现其在治疗高血压时临床有效。在该程序中,RF能量施加于肾动脉的壁,以减小肾动脉附近的交感神经系统的超活化(其通常是慢性高血压的原因)。已经发现该程序在一些情况下为成功的,但也与显著量的疼痛相关联,并且现有的治疗可为既对于医生准确执行相对困难,并且又相当耗时。
影响许多患者的另一个情况为充血性心力衰竭("CHF")。CHF是在心脏变得受损并且至身体器官的血流减小时出现的情况。如果血流充分减小,则肾功能变得改变,这导致流体潴留、异常激素分泌和增加的血管收缩。这些结果增加了心脏工作量,并且还降低了心脏经由肾和循环系统泵送血的能力。
相信,逐渐地减小的肾的灌注是维持CHF的向下螺旋的主要非心脏原因。例如,当心脏努力泵送血液时,心输出得到保持或减小,并且肾保存流体和电介质来保持心脏的心搏量。所得的压力增大使心肌进一步过载,使得心肌必须更努力地工作来克服较高压力泵送。已经受损的心肌接着进一步受压,并且由增大的压力破坏。除加剧心力衰竭之外,肾脏衰竭可导致向下螺旋,并且使肾功能进一步恶化。例如,在上文所述的顺流心力衰竭(心脏收缩心力衰竭)中,肾变得局部缺血。在向后心力衰竭(心脏舒张心力衰竭)中,肾变得相对于肾静脉高血压充血。因此,肾可有助于其自身恶化的衰竭。
肾功能可归类为三个大类:过滤血液和排泄由身体的新陈代谢生成的废物;调节盐、水、电介质和酸碱平衡;以及分泌激素来保持生命器官血流。在肾未适当起作用的情况下,患者将经受水潴留、减少的尿流,以及废物毒素累积在血液和身体中。这些情况由降低的肾功能或肾衰竭(肾脏衰竭)引起,并且被认为增大了心脏的工作量。在CHF患者中,在流体潴留并且血液毒素由于欠佳地起作用的肾而累积时,肾衰竭将引起心脏进一步变差。引起的高血压还对脑血管疾病和中风的发展具有显著影响。
自主神经系统为以可变程度影响几乎每个器官和生理系统的神经网络。大体上,系统由交感神经和副交感神经构成。例如,至肾的交感神经沿脊柱和交感神经链的神经节内或腹腔神经节内的神经键横穿交感神经链,接着经由"肾神经"内的神经节后纤维前进来刺激肾。在肾神经内,沿着肾门(动脉以及在某种程度上静脉)行进的是后神经节交感神经和来自肾脏的传入神经。来自肾脏的传入神经在后根内行进(如果它们是疼痛纤维)并且进入前根中(如果它们是感觉纤维),接着进入脊髓中并最终到达脑部的特定区域。传入神经、压力感受器和化学感受器将信息从肾脏经由脑部递送返回到交感神经系统;它们的消融或抑制至少部分地是在肾脏神经消融、或去神经支配、或部分中断之后所见到的血压改进的原因。还已经暗示和部分通过试验证明了在颈动脉窦水平下的压力感受器响应由肾动脉传入神经进行调节,使得肾动脉传入神经响应的损失减弱颈动脉压力感受器的响应以改变动脉血压(American J.Physioogy and Renal Physilolgy 279:F491-F501,2000,其公开通过引用并入本文中)。
已经证实在动物模型中心力衰竭的状态导致肾脏的交感神经活化异常高。肾交感神经活动的增加导致从体内排出的水和钠减少,以及肾素分泌增加,其刺激从肾上腺分泌醛固酮。肾素分泌的增加可导致血管紧缩素II水平的增加,其导致供应肾脏的血管收缩以及全身血管收缩,所有的这些导致了肾血流的减少和高血压。例如经由去神经支配减少交感肾脏神经活动可反转这些过程并且事实上已经在临床中显现。
正如高血压一样,交感神经过载有助于CHF的形成和发展。降肾上腺素从肾脏和心脏溢流至静脉血浆甚至在CHF患者中相比于患有原发性高血压的那些更高。慢性交感神经刺激使心脏过度工作,既直接地在心脏增大其输出时并且又间接地在收缩脉管系统向心脏泵送呈现了较高的阻力时。当心脏张紧来泵送更多血液时,左心室质量增大并且心脏重建发生。心脏重建导致了心脏的错杂的交感活化,这还破坏了心脏收缩的同步性。因此,重建最初有助于增加心脏的泵送,但最终减小了心脏的效率。左心室的功能降低进一步触动了交感神经系统和肾素血管紧张素醛固酮系统,驱动了从高血压导致CHF的恶性循环。
本公开的实施例涉及功率生成和控制设备,其通常用于目标组织的治疗以便实现疗法效果。在一些实施例中,目标组织为含有或邻近神经的组织,包括肾动脉和相关联的肾神经。在其它实施例中,目标组织为管腔组织,其还可包括患病组织,诸如在动脉疾病中发现的那些。
在本公开的又一个示例性实施例中,以目标剂量输送能量的能力可用于神经组织,以便实现有益的生物反应。例如,慢性疼痛、泌尿机能障碍、高血压和各种其它持续的病症已知通过神经组织的手术来影响。例如,已知的是,可不响应于药物疗法的慢性高血压可通过停止肾动脉近侧的过度神经活动来改进或消除。还已知的是,神经组织不会自然就拥有再生特性。因此,有可能通过破坏神经组织的传导通径来有益地影响过度神经活动。当破坏神经传导通径时,特别有利的是避免对相邻神经或器官组织的损害。引导和控制能量剂量的能力较好适于治疗神经组织。以加热或消融能量剂量,如本文所述和公开的能量输送的精确控制可针对神经组织。此外,引导的能量施加可足以瞄准神经,而不需要如在使用典型的消融探头时将需要的确切接触。例如,偏心加热可在足够高的温度下施加于变性的神经组织,而不引起消融并且不需要刺穿管腔组织。然而,还可合乎需要的是将本公开的能量输送表面构造成类似于消融探头,以由功率控制和生成设备控制的精确能量剂量来刺穿组织和输送消融能量。
在一些实施例中,去神经治疗的效力可通过在治疗之前、期间和/或之后的测量来评估,以定制对特定患者的治疗的一个或更多个参数,或识别附加治疗的需要。例如,去神经系统可包括用于评估治疗是否已经引起或正在引起目标或近侧组织中的神经活动的减少的功能,这可提供用于调整治疗参数的反馈或者指示需要附加治疗。
尽管本公开集中于在脉管系统中使用该技术,但该技术也将用于其它管腔组织。本公开可用于其中的其它解剖结构为食管、口腔、鼻腔、咽鼓管和鼓室、大脑静脉窦、动脉系统、经脉系统、心脏、喉、气管、支气管、胃、十二指肠、回肠、结肠、直肠、膀胱、输尿管、射精管、输精管、尿道、子宫腔、阴道腔以及子宫颈管道。
系统概述
图1A示出了用于在身体通路内执行治疗的系统100。系统100包括控制单元110。控制单元110可包括用于将RF能量输送至导管装置120的RF发生器。可与本文公开的实施例一起使用的示例性控制单元和相关联的能量输送方法在通过引用并入本文中的共同转让的美国专利申请公告第US 2012/0095461号中公开。可与本文公开的实施例一起使用的另外实例在标题为"Tuned
RF Energy for Selective Treatment of Atheroma and Other Target Tissues and/or
Structures"的共同转让的美国专利第7,742,795号、标题为"Selectable Eccentric Remodeling and/or Ablation of
Atherosclerotic Material"的美国专利第7,291,146号,以及标题为"System for Inducing Desirable Temperature Effects on Body
Tissue"的美国公告第2008/0188912号中公开,这些专利的全部公开通过引用并入本文中。在一些实施例中,特别是在使用单极能量输送的一些实施例中,系统还可包括可与导管装置相关联的接地/公用电极、电性地联接于控制单元110的单独的极板,或与系统100相关联的其它物件。
在一些实施例中,控制单元110可包括处理器或联接于处理器以控制或记录治疗的其它物件。处理器典型地将包括计算机硬件和/或软件,通常包括一个或更多个可编程处理器单元,其运行机器可读的程序指令或代码用于实施本文所述的实施例和方法中的一个或更多个中的一些或所有。代码通常将体现为有形的介质诸如存储器(可选为只读存储器、随机存取存储器、非易失性存储器等)和/或记录介质(诸如,软盘、硬盘驱动器、CD、DVD、非易失性的固态存储卡等)。代码和/或相关联的数据和信号还可经由网络连接(诸如,无线网络、以太网、因特网、内部网等)传送至处理器或从处理器传输,并且代码中的一些或所有还可在导管系统的构件之间传输,并且经由一个或更多个总线在处理器内传输,并且适合标准或专有通信卡、连接器、线缆等通常将包括在处理器中。处理器通常可构造成通过以软件代码对处理器编程来至少部分地执行本文所述的计算和信号传输步骤,该软件代码可写为单个程序、一系列单独的子例行程序或相关的程序等。处理器可包括标准或专有数字和/或模拟信号处理硬件、软件和/或固件,并且可合乎需要地具有足够的处理能力来在患者治疗期间执行本文所述的计算,处理器可选地包括个人计算机、笔记本计算机、平板计算机、专有处理单元或它们的组合。与现代计算机系统相关联的标准或专用输入装置(诸如,鼠标、键盘、触摸屏、操纵杆等)和输出装置(诸如,打印机、扬声器、显示器等)还可被包括,并且具有多个处理单元(或甚至单独的计算机)的处理器可在较宽范围的集中或分布式数据处理构架中使用。
在一些实施例中,用于系统100的控制软件可使用客户端-服务器方案来进一步提高系统的易用性,灵活性和可靠性。"客户端"是系统控制逻辑;"服务器"是控制硬件。通信管理器将系统状态的变化输送至预订的客户端和服务器。客户端"知道"当前系统状态是什么,并且基于状态的特定变化执行什么命令或决定。服务器基于客户端命令来执行系统功能。由于通信管理器为集中式信息管理器,故新系统硬件可不需要对之前现有的客户端服务器关系进行改变;新系统硬件和其相关控制逻辑接着可仅变为通过通信管理器管理的信息的附加"预订者"。该控制方案可提供具有固定的基本例行程序的稳健的中央操作程序;不需要基本例行程序改变以便操作设计成与系统一起操作的新电路构件。
可扩张装置和电极组件
回到图1A,导管装置120可包括可扩张装置130,其可为顺应性的、非顺应性的或半顺应性的球囊。可扩张装置130包括电性地联接于控制单元110的多个电极组件。此类电极组件可电性地构造成单极或双极的,并且还具有热感测能力。
如图1B中所示,根据多个圆筒形治疗区A-D,电极组件可布置在可扩张装置130上,这里示为在扩张状态。在其它实施例中,其中一些在下文中进一步描述,可扩张装置130或治疗系统的其它构件可包括附加电极组件,其不在治疗区中,或另外未使用,或构造成输送治疗能量。
治疗区A-D和相关联的电极组件140a-d在图1C中进一步示出,图1C为图1B的可扩张装置130的"展开"图示。在一些实施例中,可扩张装置为具有4mm直径和两个电极组件140a-b的球囊。在其它实施例中,可扩张装置为具有5mm直径和三个电极组件140a-c的球囊。在一些实施例中,如图1B中所绘,可扩张装置为具有6、7或8mm直径和四个电极组件140a-d的球囊。具有两个电极组件140a,b的4mm球囊在图1D中示出,而具有三个电极组件140a-c的5mm球囊在图1E中示出。对于这些构造中的任一个,可扩张装置可具有大约10mm到大约100mm或大约18mm到大约25mm的工作长度,其为图1B和图1C中所示的所有治疗区A-D的近似纵向跨距。电极组件140a-d可使用粘合剂附接于球囊。
图1F示意性地示出了可扩张装置的实施例,其包括单极电极190阵列(尽管电极阵列在图1B至1E中示出,但其它图也可使用单极构造)。在一些情况下,可扩张装置上的单极电极190中的一个可构造成用作其它电极的公用或接地电极。作为备选,可扩张装置上的单独的或不同地定形和构造的电极(诸如以图1F中的虚线示出的环形电极192)或其它可扩张装置上的电极(例如,图1G中的194)或与导管相关联的其它物件可构造为公用电极。在又一些情况下,接地极板可装固于患者的皮肤以用作公用电极。尽管图1G中未明确示出,但单极电极可均定位在温度感测装置近侧或温度感测装置上,类似于本文所述的其它实施例。
a.
重叠和非重叠治疗区
转到图1B,治疗区A-D沿纵轴线L-L纵向地邻近彼此,并且可构造成使得由电极组件施加的能量产生不重叠的治疗。由沿纵向相邻的双极电极组件140a-d施加的治疗为沿纵轴线L-L的周向非连续的。例如,参照图1C,在治疗区A中产生的损伤可在一些实施例中最小化关于周边(相对于该视图中的L-L沿侧向)与治疗区B中产生的损伤的重叠。
然而,在其它实施例中,由电极组件(诸如图1C中所示的电极组件)施加的能量可沿纵向、沿周向和/或另外至少一定程度地重叠。图31和图32示意性地示出了电极3102和3104可如何激励成产生重叠的治疗区的非限制性实例。尽管图31和图32中未明确示出,但电极3102和3104可均为双极电极对(或可为单个单极电极),并且可定位在导管球囊或其它可扩张装置的外表面上,使得它们沿纵向和沿周向偏离彼此(例如,如在图1C中)。如图31中所示,电极3102和3104中的各个可与治疗区相关联(或可构造成在与电极并列的组织中产生此类治疗区),该治疗区包括目标温度区(其外边界标为"TT")和热卷流区(其外边界标为"TP")。在一些实施例中,目标温度区代表处于或高于期望的目标治疗温度或在期望目标温度范围内的组织区域。在一些实施例中,目标卷流区代表不一定在目标温度处或在目标温度范围内,但呈现温度关于热卷流区外的未治疗区升高的组织区域。
不论电极/电极对之间的治疗区是否将重叠,都可被各种因素影响,该各种因素包括但不限于电极几何形状、电极放置密度、电极定位、(多个)接地/公用电极放置和几何形状(在单极实施例中)、能量发生器输出设置、输出电压、输出功率、工作循环、输出频率、组织特性、组织类型等。
在一些实施例中,双极电极对的独立电极可均限定其自身的治疗区,并且此类治疗区可部分地或完全地重叠。
在图31中,治疗区的热卷流区重叠,但目标温度区不重叠。在图32中,目标温度区和热卷流区两者重叠。在一些实施例中,治疗区的重叠可围绕装置的周边和/或围绕包绕身体通路的组织中的周边大致连续地延伸。在其它实施例中,治疗区中可存在重叠,然而重叠将不围绕周边大致连续,并且可存在治疗区中的显著间断。
已经从经验上确定的是,使用球囊安装电极的阵列的至少一些电外科系统可产生相邻电极极板之间的重叠治疗区,并且在至少一些情况下,产生围绕身体通路的周边有效地大致连续的治疗区。在一个实验中,导管和可扩张球囊类似于美国公告第2008/0188912(通过该引用整体并入)中示出和描述的,特别是在图9C处(如这里在图33中复制),用于生成相邻电极对之间的重叠治疗区,使得治疗区围绕周边大致连续地有效地延伸。如图33中所示,可扩张球囊20包括围绕球囊的周边定位的、沿纵向延伸的若干系列双极电极对34。不同于例如图1C中所示的电极阵列,图33中所示的电极阵列对称地布置在可扩张球囊20上。
在使用类似于图33的基于导管的球囊电极阵列的一个实验中,以各种功率和射频疗法持续时间(大约60℃到大约75℃达大约5秒到大约120秒)治疗或未治疗的十四个肾血管的局部反应在第28±1天和第84天评估。此外,来自总共7个动物的肾脏经由光学显微镜来评估。
肾脏和肾动脉与下方肌肉一起无损地移植,并且固定在10%中性缓冲福尔马林中。固定组织接着提交用于组织病理学处理和评估。各个脉管以近似每3到4mm修剪,直到组织被耗尽、处理、嵌入石蜡,以~5微米分成两段,并且以苏木精和曙红(H+E)和弹性蛋白三色(ET)来着色。肾脏在三个水平(头侧、中心和尾侧)处修剪、处理、嵌入石蜡、分段并且以H+E着色。所有所得的载玻片经由光学显微镜检查。
步骤的评估从在各种功率和射频疗法的持续时间下治疗或未治疗的六个急性动脉分段,并且从属的肾脏的评估示出了特征为介质和血管周组织中的凝固性坏死和胶原透明样变化的急性热变化。图34示出了以六对电极在75℃规定下治疗十秒的左肾动脉(标为A)和周围组织的截面。在图34中,轴向热损害在虚线的边界内观察到,包括对若干神经分支(如由箭头指示)、神经节(短箭头)和相邻淋巴结(LN)的一部分的损害。图35示出了以六对电极在75℃规定下治疗五秒的右肾动脉和周围组织的截面。在图35中,周向损害在虚线的边界内观察到,并且包括若干神经分支(如由箭头指示)。参照图34和图35,热损害在左动脉中治疗的最中间节段中和在右动脉的介质中是沿周向的。示出的肾脏没有治疗相关的变化。周向治疗有效到达,并且以高达10mm深的径向到达在外在肾神经分布中产生损害。存在大小可能触发显著的再狭窄反应的球囊治疗引起的最小到显著的程序损害。
图36和图37示出了在治疗后第27天的图34的左肾动脉的附加截面。图38为75℃的RF治疗的另一个代表性低等放大图像。图38中的治疗区由剩余的坏死中膜证实,并且由于较早的平滑肌细胞增生、纤维素增生和炎症渗透(例如支架)而外膜变厚。图38还示出了治疗区延伸到相邻的外膜中(如由虚线所示)。
图39-41还示出了在一些实施例中治疗区如何可在RF能量治疗过程内重叠。图39-41示出了Vessix V2导管,其在三十秒治疗的过程内定位在填充有热敏凝胶的圆筒中。图39示出了刚好在治疗开始之后的热敏凝胶,其中凝胶中的正方形斑点指示了局部电极加热。如图40中所示,当治疗进行时,凝胶中的斑点由于热传导增大尺寸并且接触。图41示出了30秒治疗完成时的凝胶,示出了斑点中的显著重叠。
b.
电极组件结构
回到图1C,各个电极极板组件包括四个主要元件,其为远侧电极极板150a-d、中间尾部160a-d、近侧电极极板170a-d,以及近侧尾部180b,d(对于电极极板组件140b和140c未示出)。参照图2A-C示出和描述了电极组件140a-d的构造细节。
图2A示出了在图1C中识别为电极组件140的电极组件200的俯视图。电极组件200构造为具有多个层的柔性电路。此类层可为连续的或非连续的,即,由离散部分构成。图2B和图2C中示出了绝缘的底座层202向电极组件200提供基础。底座层202可由柔性聚合物(诸如聚酰亚胺)构成。在一些实施例中,底座层202为近似0.5密耳(0.0127mm)厚。由多个离散迹线构成的传导层204层合在底座层202的顶部上。传导层204可为例如电沉积铜层。在一些实施例中,传导层204为近似0.018mm厚。绝缘层206离散地或连续地层合在传导层204的顶部上,使得传导层204流体地密封在底座层202与绝缘层206之间。类似于底座层202,绝缘层206可由柔性聚合物(诸如聚酰亚胺)构成。在一些实施例中,绝缘层206为近似0.5密耳(0.0127mm)厚。在其它实施例中,绝缘层206为完整或部分的聚合物涂层,诸如PTFE或硅树脂。
图2A中所示的电极组件200包括远侧电极极板208。在该区域中,底座层202形成矩形形状。如所示,电极组件200可包括提供附加柔性的多个开口,并且极板和组件的其它部分可包括圆形或弯曲转角、过渡部和其它部分。在一些情况下,开口和圆形/弯曲特征可提高对从其可扩张装置分层的组件阻力,如可在一些情况下发生的,在可扩张装置反复扩张和塌缩(这也可伴有从保护护套配置和取回到保护护套中)时,诸如可在多个部位在程序期间治疗时需要的。
远侧电极极板208包括层合在底座层202的顶部上的多个离散迹线。这些迹线包括接地迹线210、有效电极迹线212和传感器迹线214。接地迹线210包括长形电极支承件216,其沿侧向偏离传感器接地极板218。传感器接地极板218电性地联接于接地迹线210的长形支承件216,并且位于远侧电极极板208的中心。桥接件220将传感器接地极板218的最远侧部分连接于接地迹线210的长形电极支承件216的远侧部分。桥接件220随其行进至传感器接地极板218而宽度渐缩。在一些实施例中,桥接件220具有相对一致且较薄的宽度,以实现期望量的柔性。长形电极支承件216在其近端处宽度渐缩,然而,这不是必需的。在一些实施例中,长形电极支承件216可突然过渡至其近侧部分处的更薄的迹线,以实现期望量的柔性。大体上,其中示出颈缩的迹线的曲率优化以减小球囊取回力和较尖锐的轮廓可存在的任何粗加工的可能。迹线的形状和位置也优化,以向作为整体的电极组件200提供大小稳定性,以便在配置和使用期间防止变形。
图2A的接地迹线210和有效电极迹线212共用类似的构造。有效电极迹线212也包括长形电极支承件216。
图2B示出了远侧电极极板208的局部截面A-A。电极222示为层合在绝缘层206的一部分上面,该部分具有多个通道(例如,孔)以使电极222能够联接于接地迹线210的长形电极支承件216(传导层204)。
如图2A中所示,接地电极迹线210和有效电极迹线212可包括多个电极。三个电极222提供用于各个电极迹线,然而可使用更多或更少的。此外,各个电极222可具有辐射式转角以减小抓到其它装置和/或组织上的趋势。尽管电极222和与它们相关联的迹线的以上描述已经在双极电极组件的背景下描述,但本领域的技术人员将认识到相同的电极组件也可在单极模式中起作用。例如,作为一个非限制性实例,与有效电极迹线212和242相关联的电极可用作单极电极,其中接地迹线210在那些电极的激励期间断开。
已经按经验确定了,具有多个电极中每个4mm的适当纵向长度,包括电极222之间的纵向间距的肾高血压指示的示例性实施例相对于最佳损伤尺寸和深度提供了有效的组织重建结果,同时避免了狭窄反应。通过平衡热渗透的深度并且避免对与治疗区并行的组织的热伤害,同时试图最小化电极对的数量来优化最终装置上的柔性和轮廓而达到所示的构造。然而,所示构造不是所需的要求,这是因为电极尺寸和放置几何形状可根据期望的疗法效果变化。
三十三头约克夏猪通过Vessix Vascular的肾去神经射频(RF)球囊导管经受肾去神经(RDN)。通过Vessix Vascular的电极设计的假定的肾去神经通过一连串设置(电极长度、温度和持续时间的函数)完成,以比较Vessix 16 mm周向电极对具有偏离设计的2mm和4mm电极之间的、在程序后的7天和28天的安全性。检查肾动脉的组织切片来评估组织反应,包括但不限于:在7天和28天处的损害、发炎、纤维化和矿化。
利用Vessix Vascular RDN RF球囊导管治疗肾动脉导致动脉壁和相邻的外膜的一连串变化,其代表从急性的"有害"阶段到慢性的"反应/修复"阶段的动脉/外膜反应的发展。由于存在动脉壁中的这些变化和其延伸到相邻的外膜组织(理解为"治疗区")中,故肾动脉内的治疗区域为清楚的。
在第7天,所有电极不管长度、治疗温度和持续时间都与主要有害反应相关联。然而,2mm和4mm电极也与早期的反应/修复反应相关联,而不管治疗持续时间,这未在第7天在16mmRF治疗中观察到。以16mm电极影响的动脉周边的总体程度关于较短电极(2mm和4mm)增大(中度/适中到明显,分别为大约>75%到100%的被覆盖的周边),而不管温度,在该较短电极中,影响典型地为最小到中度/适中(分别为~<25%到~25%到75%的被影响的周边),而不管治疗持续时间。
在第28天,在除较短的4mm电极之外的所有治疗组中观察到频繁的最小新生内膜形成,而不管时间点。中度/适中的新生内膜形成在第28天仅较少观察到,而不管治疗组;然而,16mm电极与中度/适中新生内膜的出现关于较短的2mm和4mm电极中度且相当地增大相关联。
内皮细胞的剥蚀(即,损失)是任何介入性装置的经过的常见后遗症,以及利用Vessix 脉管 RDN RF球囊导管治疗的预计后遗症。由于内皮在防止血栓形成时的重要性,故监测其在剥蚀区域中的恢复。就此而言,管腔表面的再内皮化的大小/程度关于被影响的动脉的近似周边来解释。
在第7天,2mm和4mm的电极具有更多动脉区段完全内皮化;完全内皮化存在于2mm和4mm电极的所有动脉区段中。没有观察到以16mm电极治疗的动脉区段在第7天具有完全内皮化,而不管剂量。
在第7天,发炎总体上典型地最小,而不管治疗;然而,不管剂量,两个16mm电极都具有关于2mm和4mm电极增大的总发炎。中度/适中的发炎渗透在2mm和4mm电极中很少观察到,但在16mm电极中很常见。
在图2A的实施例中,各个电极222均为近似1.14mm乘0.38mm,其中近似0.31mm的间隙存在于电极222之间。接地迹线210和有效电极迹线212的电极222沿侧向间隔开近似1.85mm。在一些实施例中,诸如图2B中所示的实施例,电极222为从传导层204近似0.038mm厚的金极板,并且在绝缘层206上方突出0.025mm。在不限制其它此类适当材料的情况下,金为良好的电极材料,因为其非常生物相容、不透辐射并且导电和导热。在其它实施例中,传导层204的电极厚度可在从大约0.030mm到大约0.051mm的范围内。在此类厚度下,电极222的相对刚度相比于例如铜传导层204可较高。由于这一切,故使用多个电极可提高柔性(与单个电极相反)。在其它实施例中,对于电极222,电极可小到0.5mm乘0.2mm,或大到2.2mm乘0.6mm。
尽管平衡绝缘层206上方的金的厚度以便实现良好的柔性同时保持足够高度以便提供良好组织接触是重要的设计优化考虑,但这以避免可在球囊的配置或塌缩期间抓住的表面高度的目标来抗衡。这些问题根据特定程序的其它元素变化,诸如,球囊压力。对于许多实施例,已经确定了在绝缘层206上方突出近似0.025mm的电极将在低于10atm和低到2atm的球囊充胀压力下具有良好的组织接触。这些压力远低于血管形成术球囊的典型充胀压力。
传感器迹线214位于远侧电极极板208的中心,并且包括面对传感器接地极板218的传感器功率极板224。这些极板可连接于热感测装置226(诸如热电偶(例如,T型构造:铜/或康铜)或热敏电阻)的功率极和接地极,如图2C中绘出的局部截面所示。
热感测装置226沿近侧连接于传感器功率极板224,并且沿远侧连接于传感器接地极板218。为了有助于减小总体厚度,热感测装置226定位在底座层202的开口内。在一些实施例中,热感测装置226为具有0.1mm厚度的热敏电阻,其通常较薄—近似为行业标准的三分之二。如所示,热感测装置226在远侧电极极板208的非组织接触侧上。因此,热感测装置226在并入到最终装置(诸如导管120)中时捕集在电极结构与球囊之间。这是有利的,因为表面安装的电气构件(如热敏电阻)典型地具有尖锐边缘和转角,其可卡在组织上,并且可能在球囊配置和/或收缩中引起问题。该布置还保持软钎焊接头免于与血液接触,因为软钎焊典型地是非生物相容的。此外,由于热感测装置的放置,故其可测量代表组织和电极222的温度。现有技术中的设计典型地采用两个途径中的一个—接触组织或接触电极。这里,不使用这些现有途径中的任一个。
从矩形远侧电极极板208,组合的底座层202、传导层204和绝缘层206的侧向宽度减小至中间尾部228。这里,传导层204形成为包括中间接地线230、中间有效电极线232和中间传感器线234,它们分别为远侧电极极板208的接地迹线210、有效电极迹线212和传感器迹线214的共同延伸的迹线。
从中间尾部228,组合的底座层202、传导层204和绝缘层206的侧向宽度增大以形成近侧电极极板236。近侧电极极板236与远侧电极极板208类似地构造,其中电极几何形状和热感测装置布置基本上相同,但可存在各种差异。然而,如所示,近侧电极极板236相对于沿中间接地线230延伸的中心轴线G-G沿侧向偏离远侧电极极板208。中间有效电极线232和中间传感器线234与相对于中心轴线G-G在平行的相应轴线上的近侧电极极板236沿侧向共同延伸。
从近侧电极极板236,组合底座层202、传导层204和绝缘层206的侧向宽度减小以形成近侧尾部238。近侧尾部238包括近侧接地线240、近侧有效电极线242和近侧传感器线244,以及中间有效电极线232和中间传感器线234。近侧尾部238包括连接器(未示出),以使得能够联接于一个或更多个子线束和/或连接器,并且最终连接于控制单元110。这些线中的各个沿相对于中心轴线G-G平行的相应轴线延伸。
如所示,电极组件200具有围绕轴线G-G的远侧电极极板208和近侧电极极板236的非对称布置。此外,两个电极极板的接地电极连同中间接地线230和近侧接地线240大致沿轴线G-G对准。已经发现该布置存在许多优点。例如,通过基本上共用相同的接地迹线,近侧尾部的宽度仅为中间尾部228的大约一点五倍,而非在各个电极极板具有独立接地线的情况下为近似两倍宽。因此,近侧尾部238比中间尾部228中的两个更窄。
此外,布置电极极板来共用接地地线允许了对电极将与彼此相互作用的控制。这在查看单个电极组件时不是立即清楚的,而是在一个以上的电极组件200组装到球囊上(例如,如图1C中所示)时变得明显。各种电极极板可使用固态继电器和多路复用来激发和控制,其中激发时间的范围从大约100微秒到大约200微秒,或大约10毫秒到大约50毫秒。为了实用的目的,电极极板似乎是同时激发,但不同电极组件200的相邻电极极板之间的杂散电流通过电极以微爆发来快速激发而防止。这可执行成使得不同电极极板组件200的相邻电极极板与彼此异相激发。因此,电极组件的电极极板布置允许短治疗时间,10分钟或更短的总电极激发时间,其中一些近似治疗时间短到10秒,其中并且示例性实施例为大约30秒。短治疗时间的益处包括在神经组织经受能量治疗时引起的手术后疼痛的最小化、缩短脉管闭塞时间、减小闭塞副作用,以及由于至管腔组织的相对较小的热输入而通过血液灌注快速冷却并行组织。
在一些实施例中,公共接地典型地承载来自电极阴极的500kHz下的200VAC,以及来自热感测装置226(在热敏电阻的情况下)的1V信号,其需要RF电路滤波使得热敏电阻信号可被感测到并且用于发生器控制。在一些实施例中,由于公共接地,故相邻电极对的热敏电阻可用于监测温度,甚至在没有激发相邻电极对的情况下。这提供了感测远侧电极极板208和近侧电极极板236两者近侧的温度同时仅激发它们中的一个的可能性。
再次参照图1C,各个电极组件140a-d的电极极板布置还实现了在球囊130上的有效放置。如所示,电极组件140a-d"键"入彼此中,以实现球囊表面面积的最大使用。这部分地通过经由设置各个中间尾部的纵向长度而间隔开电极极板来实现。例如,电极组件140a的中间尾部长度设置成一距离,该距离分开其远侧电极极板150a和近侧电极极板170a,使得侧向相邻的电极组件140b的侧向相邻的近侧电极极板170b键合到电极组件140a的中间尾部160a旁边。此外,电极组件140a的远侧电极极板150a键合在电极组件140b的中间尾部160b与电极组件140d的中间尾部160d之间。因此,各个中间尾部160a-d的长度还需要任一个电极组件的各个电极极板位于非相邻的治疗区中。
还通过使各个电极组件140a-d的两个电极极板沿侧向偏离而部分地实现了球囊表面面积的最大化。例如,各个远侧电极极板150a-d的向右的侧向偏离和近侧电极极板170a-d的向左的侧向偏离允许相邻电极极板组件键合到彼此中,使得电极极板中的一些沿侧向彼此重叠。例如,电极组件140a的远侧电极极板150a与电极组件140b的近侧电极极板170b沿侧向重叠。此外,电极组件140b的远侧电极极板150b与电极组件140c的近侧电极极板170c沿侧向重叠。然而,各个中间尾部的长度防止电极极板的周向重叠(在该视图中是纵向重叠),因此保持治疗区沿纵向方向L-L的非邻接性质。
电极极板的布置和几何形状以及柔性电路的尾部的布置和几何形状还可便于使球囊折叠或另外塌缩至相对紧凑的非扩张状态。例如,在具有高达10mm的扩张直径的实施例中,非扩张状态中的装置可具有小到近似1mm的直径。
一些实施例使用具有相等的大小和构造的标准电极组件,其中球囊的外表面上的电极组件的数量和相对位置变为球囊直径和/或长度的函数,同时电极组件几何形状在各种球囊尺寸之间仍不变。电极组件关于球囊直径和/或长度的相对定位接着可通过给定尺寸的球囊上的邻近电极组件的相邻电极极板的周向和/或轴向重叠的期望程度或避免来确定。然而,在其它实施例中,球囊上的所有电极组件将不一定相同。
图3A-3D示出了可与图1A的系统100一起使用的备选电极极板构造。图3A示出了电极组件300,其类似于电极组件200构造,但具有直接地邻近彼此的两个电极极板302。
图3B示出了电极极板组件304,其类似于电极组件200构造,但具有直接地邻近彼此的两个电极极板306。此外,电极极板306具有布置成相对于图1C的纵轴线L-L和图2A的G-G横穿的电极。
图3C示出了电极组件310,其类似于电极组件304构造,但具有三个交错且分开的电极极板312。类似于图3B的电极组件304,电极极板312的特征在于横穿地布置的电极。
图3D示出了电极组件314,其类似于电极组件310构造,但具有带较大电极表面面积的电极极板312。类似于图3B的电极组件304,电极极板316的特征在于横穿地布置的电极。
图4A-4C示出了可与图1A的系统100一起使用的备选电极极板构造。图4A示出了电极组件400,其类似于电极组件200构造,但具有仅单个远侧电极极板402。
图4B示出了电极组件404,其类似于电极组件400构造,但具有单个远侧电极极板407,其具有大于接地表面面积410的有效电极408表面面积。
图4C示出了电极组件412,其类似于电极组件404构造,但具有单个远侧电极极板414,其具有非常多孔的构造以实现更大的柔性。
图5A-5F示出了可与图1A的系统100一起使用的备选电极构造。在一些实施例中,所示的电极构造可与图4A-4C的构造一起使用。图5A示出了电极组件500,其类似于电极组件400构造,但布置成仅包括单个近侧电极极板502。电极组件500还包括用于附接于球囊的长形远侧部分504。
图5B示出了电极组件506,其类似于电极组件500构造,但具有电极极板508上的相比较大的电极表面面积。
图5C示出了电极组件510,其类似于电极组件500构造,但具有电极极板512上相比较大的电极表面面积和较大数量的电极。
图5D示出了电极组件514,其类似于电极组件510构造,但具有电极极板512上非一致的电极构造。
图5E示出了电极组件514,其类似于电极组件500构造,但具有电极极板516上的相比较小的电极表面面积,以及较少数量的电极518。电极极板516还结合安装在同一侧上的两个热感测装置520作为电极。
图5F示出了电极组件522,其类似于电极组件514构造,但具有横向布置的电极524和单个热感测装置526。
图2至5F的电极组件可以以双极或单极构造使用。图5G至5I示出了单极电极构造的附加实例。在图5G中,两个平行阵列的单极电极530在温度传感器532的任一侧上。在图5G中,各个阵列的单极电极530具有其自身的离散迹线,其中温度传感器532还具有其自身的离散迹线。然而,在其它实施例中,特定柔性电路组件上的所有单级电极530可共用单个有效迹线,并且温度传感器的两个迹线中的一个也可共用,但在其它实施例中,用于温度传感器的功率迹线和接地迹线可与(多个)单极迹线分开。
图5H示出了单极电极极板的另一个布置,其中所有单极电极536联接于单个迹线。图5I示出了单极电极和温度传感器的另一个备选布置。单极电极极板可围绕可扩张装置以沿纵向和沿周向偏离的布置(诸如图1C中所示)来布置,并且可具有类似于图3A至5F中所示的那些的几何形状和布置。
治疗方法和控制系统
a.
装置定位
图6示出了图1A的系统100,其用于执行根据本公开的一个非限制性实施例的治疗方法600。这里,控制单元110示为操作地联接于导管装置,其置于身体通路中,使得可扩张装置(具有多个电极组件)置于需要疗法的身体通路的区段S1附近。将导管装置置于区段SI处可根据常规方法执行,例如,在荧光检查引导下在导线之上。
一旦置于S1中,则可扩张装置可例如通过在球囊的情况下将流体从2atm加压至10atm来产生扩张。这引起可扩张装置的电极与身体通路接触。
在一些实施例中,控制单元110可测量电阻组件处的阻抗,以确认电极与身体通路的并列。在这些实施例中的至少一些中,即使对于所有电极并未感测到并列,也可进行治疗。例如,在一些实施例中,如果对于50%或以上的电极感测到并列,则可进行治疗,并且可允许沿周向和/或沿轴向的并列的低于完全的一致。例如,在一些情况下,导管可定位成使得近侧电极中的一个或更多个在主动脉中并且暴露于血液,并且对于此类电极感测到的阻抗可不落入预先指定的范围(诸如,例如,500到1600欧姆)内,指示了对于那些电极没有组织并列。在一些情况下,即使存在低于一致的电极/组织并列,系统仍可允许使用者授权进行治疗。随后,如黑色正方形指示,控制单元110可触动电极来产生对应数量的损伤L。在电极触动期间,控制单元使用电极极板的热感测装置,以由于热感测装置的独特布置而监测电极和组织两者的热,该热感测装置不接触组织或电极。以该方式,更多或更少的功率可在治疗期间按需要供应至各个电极极板。
在一些实施例中,控制单元110可应用一致的标准来确定与装置的所有电极的并列。例如,控制单元可使用对所有电极预先指定的相同电阻测量范围。然而,在其它情况下,包括一些但不是所有单极应用,不同标准可应用于不同单极电极用于确定并列。例如,在一些单极实施例中,各个单极电极可限定穿过组织至公用/无关电极(或多个电极)的离散电路,并且那些电路的特性(例如,电阻)可基于单极电极和公用电极之间的距离、其间的组织特性,以及装置和周围组织的其它几何形状和特性显著地变化。因此,在至少一些实施例中,可合乎需要的是应用标准来确定并列,其取决于例如单极电极与公用电极之间的距离变化(例如,两个电极之间的距离越大,则确定良好并列所需的阻抗测量结果越高)。然而,在其它实施例中,由于距离和其它几何形状中的这些差异而引起的变化将最小或并非相当大,并且可应用一致的标准。
图24A-F示出了在治疗过程期间由控制单元显示的一系列屏幕截图的一个非限制性实例。在图24A中,系统提示使用者连接导管。在图24B中,系统确认导管已经连接,以及关于连接的导管的其它信息(例如,尺寸/直径)。在图24C和D处,如上文所述,系统可检查电极并列,指示了哪个或多少电极并列,并且请求授权来进行。在图24C中,三个电极(例如,头三个或"近侧"电极)示为并列,而在图24D中,所有电极示为并列。在图24E和F中,系统可显示在治疗期间和在治疗之后两者的治疗的某些参数(例如,功率、温度、时间和有效/激活电极的数量)。关于治疗的信息(诸如,前述参数和/或其它信息)可由系统获取并且储存至存储器。
回到图6,在区段S1中的规定疗法完成之后,可扩张装置接着可泄放并且移动至未治疗区段S2来重复在区段S1中施加的疗法,并且类似地在区段S3和按需要的任何其它区段上重复。区段示为直接地相邻,但可由一些距离分开。
在一些情况下,将使用除图6中所示的那些之外的备选方法。例如,在其它实施例中,治疗将仅在通路中的单个位置处执行,但将不需要使可扩张装置移动至通路中的多个位置。
再次参照涉及过渡神经活动降低的肾高血压的实例,系统可用于实现非刺穿非消融的方式以引导能量以影响神经活动。因此,所示的身体通道可为由区段S1-S3中的神经组织N包绕的肾动脉。可扩张装置上的电极可被供能以沿待影响的神经N的已知方向输送能量,能量穿透的深度为能量剂量、电极类型(例如,单极对双极)和电极几何形状的函数。其全部公开通过引用并入本文中的标题为"System
for Inducing Desirable Temperature Effects on Body Tissue"的美国公告第2008/0188912描述了可在一些但不一定是所有实施例中考虑的电极几何形状和组织治疗区体积的一些考虑因素。在一些情况下,实验分析可用于确定神经组织N的阻抗特性,使得导管装置可用于首先特征化,并且接着以如本文公开和描述的目标方式治疗组织。能量的输送和管控还可进一步涉及累积的伤害模拟。
如所述,各个损伤L以可扩张装置130的对应的治疗区A-D产生。因此,以一个特定治疗A-D区得到的任何损伤L将不在沿操作轴线O-O的任何点处与相邻治疗区A-D的损伤沿周向重叠。在一些实施例中,可扩张装置130的治疗区可具有一个以上的电极极板,并且因此在此类情况下,由那些电极极板产生的损伤L可沿周向重叠。在那些情况下,对于特定组织结构可需要更多损伤L,或者需要一对电极极板来在施加疗法之前执行诊断例行程序。不管怎样,相邻治疗区的电极的周向重叠将不存在。
b.
能量输送
取决于所需的特定重建效果,控制单元可以以大约0.25到5瓦的平均功率激励电极1到180秒,或以大约0.25到900焦耳。较高能量的治疗可在较低功率下并且以较长持续时间完成,诸如0.5瓦90秒,或0.25瓦180秒。在单极实施例中,控制单元可以以高达30瓦激励电极高达5分钟,这取决于电极构造和电极与公共接地之间的距离。较短距离可提供较低能量较短时间段,因为能量以较少传导损失在更局部的区域之上行进。在用于肾去神经的示例性实施例中,能量在大约5瓦的治疗设置下输送大约30秒,使得治疗区在治疗期间加热至大约68℃。如上文所述,功率需求可极大地取决于电极类型和构造。大体上,在较宽电极间距的情况下,需要更多功率,在该情况下,平均功率可高于5瓦,并且总能量可超过45焦耳。同样,使用较短或较小的电极对将需要按比例缩小平均功率,并且总能量可小于4焦耳。在一些情况下,功率和持续时间可校准至不足以引起严重伤害,特别是不足以消融血管内的患病组织。已经充分地描述消融血管内的动脉粥样硬化材料的机构,包括Slager等人在J. of Amer Cardiol(1985年6月)1382-6页的标题为"Vaporization of Atherosclerotic Plaque by Spark Erosion"的论文中,以及Stephen M. Fry在Strategic Business Development
Inc.(1990)的"Thermal and Disruptive Angioplasty: a Physician' s Guide"中,其全部公开通过引用并入本文中。
在一些实施例中,应用于肾动脉中的一条或两条的能量治疗可在高于在其它身体通路中将可能的水平下施加,而没有有害效应。例如,如果经受高于一定热反应极限的加热,则身体的外周和冠状动脉可对于有害的长期闭塞反应敏感。已经发现,然而,肾动脉可经受高于此类热反应极限的加热,而没有有害效应。
在一些实施例中,能量治疗可施加于患者肾动脉中的一条或两条来影响肾脏中的交感神经活动,以便缓解CHF的心脏收缩和心脏舒张形式两者。将疗法热能施加于肾动脉近侧的组织可有效减小交感神经活动,以便缓解生物过程和所得的CHF效应。在一些实施例中,在快速程序(例如,每个肾脏10分钟或更短的疗法时间)中的受控剂量的热能的适中施加用于以便向临床人员提供简单的程序,同时提供最小化患者感觉到的疼痛同时最大化程序的效力的程序。本公开的球囊安装的电极和能量输送方法可特别良好地适用于施加能量来减少与心脏收缩和心脏舒张CHF结合或分开的慢性高血压相关的交感神经活动。
在一些实施例中,本文所述的电极极板可被激励来评估并且接着有选择地治疗目标组织来通过重建治疗的组织而实现期望的疗法结果。例如,组织特性可用于借助于阻抗测量来识别组织治疗区域。使用身体通道内沿周向间隔开的电极的阻抗测量可用于分析组织。例如,当电路路径穿过患病组织时,以及当其穿过管腔壁的健康组织时,成对的相邻电极之间的阻抗测量可不同。因此,患病组织的任一侧上的电极之间的阻抗测量可指示损伤或其它类型的目标组织,而其它成对相邻电极之间的测量可指示健康组织。其它特征化(诸如血管内超声波、光学相干断层成像等)可用于连同阻抗测量或作为阻抗测量的备选方案来识别待治疗的区域。在一些情况下,可合乎需要的是获得待治疗的组织的基准测量结果以有助于区分相邻组织,因为组织特性和/或特性轮廓可在人与人中不同。此外,组织特性和/或特性轮廓曲线可标准化,以便于识别不同组织之间的相关的斜率、偏离等。阻抗测量可在一个或更多个频率下完成,理想的是在两个不同频率(低和高)下。低频测量可在大约1到10kHz或大约4到5kHz的范围中完成,并且高频测量可在大约300kHz到1MHz的范围中或在大约750kHz到1MHz之间完成。较低频率的测量主要代表阻抗的电阻分量,并且与组织温度接近地相关,其中较高频测量代表阻抗的电容分量,并且与细胞成分中的破坏和变化相关。
由于阻抗的电容变化和电阻变化引起电流与电压之间的峰值变化,故阻抗的电阻分量与电容分量之间的相角转移也出现。还可监测相角转移来作为评估RF去神经期间的组织接触和损伤形成的手段。
在一些实施例中,身体管腔的重建可通过与缓和或标准的扩大组合的缓和加热来执行。例如,具有设置在其上的电极的血管成形术球囊导管结构可在扩大之前、期间和/或之后将电势施加于血管壁,该电势可选为与处于或显著低于标准未加热血管形成术扩大压力的扩大压力组合。在10到16个大气压的球囊充胀压力例如可适于特定损伤的标准血管形成术扩大的情况下,与本文所述的适当的电势(通过球囊上的柔性电路电极,直接沉淀在球囊结构上的电极等)组合的改变的扩大治疗可使用10到16个大气压,或者可以以6个大气压或更小(并且可能低到1到2个大气压)的压力实现。此类中等扩大压力可(或可不)与组织特征化、调节的能量、偏心治疗和本文对于身体管腔、循环系统和外周脉管系统疾病的治疗所描述的其它治疗方面中的一个或更多个方面组合。
在许多实施例中,在身体管腔的扩大之前、期间和/或之后添加的缓和的加热能量可增大扩大有效性,同时减少并发症。在一些实施例中,以球囊的此类受控加热可呈现出反冲的减小,提供了支架状扩张的益处中的至少一些,而没有植入物的缺点。加热的益处可通过将外膜层的加热限制在有害响应阈值以下来提高(并且/或者抑制并发症)。在许多情况下,内膜和/或介质的此类加热可使用小于大约10秒的加热时间来提供,通常小于3(或甚至2)秒。在其它情况下,非常低的功率可用于较长的持续时间。通过将电路的驱动势与目标组织的相角相匹配而将能量有效耦合至目标组织可提高合乎需要的加热效率,有效地使电功率曲线下方的区域最大化。相角的匹配不必是绝对的,并且同时与特征目标组织的完全相匹配可具有益处,备选的系统可预设适合的电势来大致匹配典型的目标组织;但实际相角可不精确地匹配,目标组织内的加热定位可显著好于使用标准功率形式。
在一些实施例中,如上文所述,单极(单极性)RF能量施加可在球囊上的电极中的任一个与定位在外皮或装置自身上的返回电极之间输送。单极RF可在需要较深损伤的区域中是合乎需要的。例如,在单极应用中,各个电极对可以以阳极供能,而非每对具有一个阳极和一个阴极。在一些实施例中,单极和双极RF能量施加的组合可在各种深度/尺寸的损伤可通过改变成对电极的极性来有选择地实现的情况下完成。
c.
目标温度
RF能量的施加可受控,以便限制目标和/或附属组织的温度,例如限制目标组织的加热使得目标组织或附属组织都不维持可逆的热伤害。在一些实施例中,表面温度范围从大约50℃到大约90℃。对于缓和的加热,表面温度的范围可从大约50℃到大约70℃,而对于更强的加热,表面温度的范围可从大约70℃到大约90℃。限制加热以便阻止附属组织加热至小于范围从50℃到大约70℃的表面温度,使得大块组织温度仍大部分低于50℃到55℃可阻止免疫反应,该免疫反应否则可导致狭窄、热伤害等。在50℃到70℃之间的相对适中的表面温度可足以在治疗期间、治疗之后不久和/或治疗之后超过一小时、超过一天、超过一星期,或甚至超过一个月通过组织对治疗的愈合反应来使蛋白质键变性和断开以便提供较大的脉管管腔和改进的血流。
在一些实施例中,目标温度可在治疗期间变化,并且例如可为治疗时间的函数。图7示出了具有30秒持续时间和从标称体温缓升到大约68℃的最大目标温度的十二秒的治疗的一个可能的目标温度曲线。在图7中所示的实施例中,在十二秒缓升阶段期间的目标温度曲线由二次方程限定,在该二次方程中,目标温度(T)为时间(t)的函数。方程的系数设置成使得从标称体温到68℃的缓升遵循类似于抛射体达到重力影响下其行进弧线的最大高度的轨迹的路径。换言之,缓升可设置成使得在达到12秒和68℃时,存在温度缓升的恒定减速度(d2T/dt2),以及温度升高的线性减小的斜率(dT/dt)。具有在其接近68℃时在斜率上的其逐渐减小的此类曲线可便于最小化治疗的其余部分的设置目标温度的超过目标和/或未达目标。在一些实施例中,图7的目标温度曲线将同样适用于双极或单极治疗,但在至少一些单极实施例中,治疗时间可增加。
图8、9和10示出了用于在本公开的各种实施例中使用的附加目标温度曲线。图8示出了具有变化的升高时间和设置目标温度的曲线(例如,一条曲线具有近似3秒升高时间和55℃的设置温度,一条具有5秒的升高时间和60℃的设置温度,一条具有8秒的升高和65℃的设置温度,一条具有12秒升高和70℃设置温度,并且一条具有17秒升高和75℃设置温度)。
图9和10示出了使用不同升高曲线的温度曲线,其中一些相对积极地接近设置目标温度(例如,"快速升高"曲线),其中另一些较不积极地接近设置目标温度(例如,"缓慢升高"曲线)。已经在实验中确定了图10中所示的"中等加强升高"温度曲线向至少一些治疗协议提供了最佳结果,但不是本公开的所有实施例都限于该温度曲线,并且不同治疗和不同环境可有利地使用其它曲线。中等加强升高可为示例性实施例,其中其将目标组织有效地加热至目标温度,同时避免了更积极的加热曲线可引起的有害的微观热伤害,同时还提供了最佳的总体治疗时间。对于所示的目标温度曲线中的各条,可使用体现或接近二次方程的温度缓升,然而可使用有效地加热组织、优化治疗时间和避免对目标组织的热伤害的任何函数或其它曲线。然而,在又一些实施例中,将不需要使用实现所有这些目标的温度曲线。例如而不限制,在至少一些实施例中,治疗时间的优化可不为必需的。
进行了台上实验和动物实验两者来优化和检验Vessix系统的去神经实施例中使用的目标温度曲线。下文总结了作为示例性实施例的支持选择中等加强升高温度曲线的台上实验和分析。
执行了测试来确定哪种升高时间算法将提供最佳水平的有效性和安全性。一些之前的升高时间算法已经尽可能快地简单地到达设置温度,并且相信这不一定是至少一些情形中的最佳动作过程。利用三个无维参数来定性地评估效力。目标在于确定算法,该算法将在治疗区处产生基于目视检查的组织的最少量的烧焦、变性和脱水,同时还提供了良好的效力。
使水浴高达37℃以模拟体温,并且肝脏样本置于浴中来模拟体内条件。装置的良好并列通过注意与组织接触的各个双极电极对的电极组织界面的阻抗值来检验。较高的阻抗(>500欧姆)用作良好并列的基准点。
在图9和10中的温度曲线运行之后,肝脏标本在各个治疗部位处测量表面处的损伤的长度和宽度、穿透深度,以及2mm深处的损伤的长度和宽度。分析人员不知道以什么顺序完成了哪个治疗以便减小报告的偏差。任何观察到的显著组织伤害也被记录。
图11和12以表格形式示出了对于其它效力度量的相关穿透深度产生的效力量度。第一是穿透深度除以表面处的损伤面积的平方根。该量度使表面上的损伤伤害的深度与表面损伤的面积以无维形式相关。100%的值意味着穿透深度等于表面损伤的平均尺寸。下一个量度为2mm处的面积除以表面处的面积。该量度显示出热穿透组织有多良好。100%的值意味着在2mm深的面积和表面面积相同。最后一个量度为穿透深度乘2mm处的损伤宽度除以表面处的面积。该数字提供了关于损伤的大体形状的信息,以及能量是否趋于从电极部分地传播或刺穿组织。100%的值意味着损伤尺寸的截面面积等于损伤的表面的尺寸。
在仔细回顾所有实验数据之后,决定中等加强升高曲线是最佳温度升高算法以用于某些实施例,但再次,其它目标温度曲线还可适当地连同本公开的公开实施例使用。
d.
控制算法
图13和14示出了用于基于目标温度曲线(诸如上文所述和图7-10中所示的那些)或其它曲线控制电外科装置(诸如上文所述和图1-6中所示的那些)或其它装置的能量施加的方法的一个实施例。控制方法可使用图1的控制单元110和/或上文更详细描述的控制软件的处理功能来执行,或另外执行。在至少一些情况下,控制方法提供了装置的各种治疗部位处的温度或(多个)其它治疗参数的微调,同时使用相对简单且稳健的能量发生器来同时在单个输出设置(例如,电压)下激励电极中的若干个或其它输送部位,这可最小化系统的成本、尺寸和复杂性。控制方法可最小化与目标温度或(多个)其它治疗参数的偏差,并且因此最小化在治疗的任何时间段期间对能量发生器的需要(例如,电压需要)的变化。
在一些实施例中,将合乎需要的是基于目标温度曲线(诸如上文所述的那些)来调节RF或其它能量的施加,以提供缓和的、受控的加热,这避免了施加高瞬时功率和微观水平下的相关联的组织烧焦或其它伤害,其可非合乎需要地导致热阻挡或另外引起装置/组织界面处的导热热传递的净减小。换言之,通过避免较高的温度摆动和所得的较大瞬时能量施加来重新建立目标温度附近的温度,可保存紧接对接位置处的组织完整性。装置干燥可导致导热性的净损失,导致缓和的疗法能量输送有效传递至超过电极/组织界面的目标组织的减少。
本领域的技术人员将认识到,尽管图13和14的特定控制方法出于图示目的在上文已经描述的特定电外科装置的背景下提出,但这些控制方法和类似方法可有益地应用于其它电外科装置。
大体上,图13和14的控制方法实施例试图将各种治疗部位保持在预先限定的目标温度处,诸如在图7-10的目标温度曲线中的一条处。在该实施例中,主要通过调节RF发生器的输出电压和确定哪个电极将在给定时间段被激励来完成(例如,通过对于该循环,将特定开关切换成开启/关闭)。
发生器的输出设置和电极的切换可通过反馈环来确定,该反馈环考虑了测量温度以及前述期望输出设置。在特定治疗循环(例如,治疗的25毫秒的时段)期间,电极中的各个可识别用于三个状态中的一个:关闭、激励或测量。在一些实施例中,如果在默认电极状态为关闭的情况下,它们满足一定标准,则电极将仅处于激励和/或测量状态(受激励的电极也可测量)。已经识别为激励或测量电极的电极可具有施加的电压,或检测循环的一部分或整个循环的温度信号。
图13和14的控制环实施例设计成保持尽可能与候选电极一样多,尽可能接近目标温度,同时最小化温度变化,并且因此最小化治疗循环到治疗循环的电压需求的变化。图15示出了电极的四个治疗循环内的示例性时间/温度图,示出了控制算法的一个实施例如何保持目标温度。
现在将详细描述图13和14的控制环实施例。
如步骤1300处指示,各个电极开始设置成关闭。在步骤1302处,电极中的一个指定为治疗循环的主电极。如下文进一步详细论述,在治疗期间,指定的主电极将从治疗循环到治疗循环(例如,通过所有可用电极的循环)变化。确定哪个电极将指定为主电极可通过访问查找表或使用任何其它适合的功能来完成,用于识别主电极,并且改变从治疗循环到治疗循环的主电极的选择。
在步骤1302处,附加电极还可指定为候选电极用于在该治疗循环期间激励和/或测量。指定的附加电极可依靠处于关于该治疗循环的指定主电极的某些关系或缺少该某些关系而为候选的。
例如,在一些双极电极实施例中,电外科装置上的电极中的一些可以以如下方式布置,使得如果主电极和那些附加电极在治疗循环中同时激励,则可存在主电极与那些其它电极之间的电流泄漏的可能性,这可非合乎需要地引起相关联的热感测装置对温度测量的干扰、在各个电极处输送的能量的量的不准确,或其它非合乎需要的结果。例如,在图1C中所示的实施例中,如果电极极板150c指定为主电极,具有紧邻或邻近电极极板150c的阳极的阴极的电极极板150d和170d可认作不是用于特定治疗循环的测量和/或激励的候选,因为它们在指定的主电极近侧引起泄漏。此外,在该实施例中,具有紧邻或邻近电极极板150c的阴极的阳极的电极极板150b可认作不是候选,因为其也在指定主电极近侧引起泄漏。此外,在该特定实施例中,电极极板170b也将认作是非候选的,因为其在与引起泄漏的近侧电极极板150b相同的挠曲结构上。最后,在该特定实施例中,电极极板150a和170a将认作是候选,因为它们邻近非候选。
作为另一个非限制性实例,在一些单极电极实施例中,候选电极为单极电极,其具有与同主电极相关联的电路的一个或更多个测量或估计的性质相似的测量或估计的电路性质。换言之,在一些单极系统中,可合乎需要的是仅同时激励单极电极,该单极电极限定大致类似于由主单极电极限定的电路的电路(例如,由单极电极、公用电极和穿过患者组织的通径限定的电路)。在一些情况下,这可便于激励期间电流流动的一致性。在其它实施例中,预先限定的表格或其它清单或相关性将基于当前主电极来确定哪个电极是候选电极。
在至少一些实施例中,与非候选相关联的开关将断开以使非候选与系统的其余电路隔离开。在至少一些实施例中,该切换还可或作为备选用于另外使可用于激励的可用电极对的数量最大化,假设对之间的公共接地不被切断影响。
在其它实施例中,电外科装置可构造成避免泄漏的可能性或另外考虑此类泄漏,并且因此,装置的所有电极都可为治疗循环期间用于激励和/或测量的候选。
在一些实施例中,作为主电极、候选或非候选的电极的指定可由阵列中的序列矩阵或查找表来确定,其识别电极中的各个的状态,以及指定主电极的顺序。在一个非限制性实施例中,主电极指定循环沿周向穿过近侧电极,并且接着沿周向穿过远侧电极(例如,在图1C中,序列可为170a,b,c,d,150a,b,c,d)。然而,可使用任何图案或其它方法,包括优化序列中的下一个之间的距离、序列中的下一个的接近性,或分布的均匀性的图案或方法。
在一些实施例中,附加条件可导致对于特定治疗循环和/或对于治疗的其余部分,特定电极设置成关闭。例如,如下文所述,在治疗过程期间,可允许差不多4℃的温度超过目标(例如,即使此类超过导致电极未受到激励,其也将不一定设置成关闭,并且仍可用于测量);然而,在至少一些实施例中,如果八个连贯的治疗循环测量到特定电极的温度超过,则电极对于其余的治疗将设置成关闭,其中治疗另外继续,并且不另外改变下文所述的控制环过程。
在步骤1304处,确定主电极和其它候选电极中的各个的目标电压。在该特定实施例中,特定电极的目标电压可基于与该电极的治疗部位相关联的温度误差以及该电极的上个计算的目标电压(但不一定应用)来确定。温度误差可通过测量治疗部位处的当前温度(例如,使用与治疗部位近侧的电极相关联的热感测装置)和确定治疗中的瞬时时间的测量温度与目标温度之间的差异来计算。
本领域的技术人员将认识到,尽管该特定实施例描述为使用电压作为控制变量,但功率可用作电压的备选物来基于例如功率与电压之间的已知关系(即,功率等于电压乘电流或阻抗)用于控制变量。
图14示出了用于确定电极的目标电压的子例行程序的一个实施例。在1402处,与目标的温度误差(Te)通过从实际温度(T)(例如,如由与电极相关联的热敏电阻测量)减去此时的目标温度(Tg)来计算。在1404处,确定1402处计算的温度误差是否大于4℃(即,如果目标温度为68℃,则确定由热敏电阻测量的温度是否高于72℃)。如果温度误差大于4℃,则子例行程序向该电极分配零目标电压用于1406处的该治疗循环。如果温度误差不大于4℃,则子例行程序前进到1408,并且确定温度误差是否大于2℃。如果温度误差大于2℃,则在1410处,子例行程序向该电极分配该电极的上个指定目标电压的75%(或另一百分比)的目标电压。如果温度误差不大于2℃,则在1412处,子例行程序可基于方程来向该电极分配目标电压:
其中:
V为目标电压;
Te为与目标的温度误差;
VL为上个分配的目标电压;
KL,KP和KI为常数;并且
n为范围从0到t秒的时间值。
在一些实施例(包括图14的实施例)中,使用的方程可为:
其中:
V为目标电压;
Te为与目标的温度误差;
VL为上个分配的目标电压;
KP为来自比例控制的常数;以及
KI为来自积分控制的常数。
在一些实施例中,其可有益于仅使用上个分配的电极电压来用于确定目标电压,而非使用来自早期治疗循环的电压或多个电压的平均值,因为在一些情况下,早期电压的使用可为集中于目标温度的精密控制的实施例中的计算误差的来源。
回到图13,一旦确定主电极和其它候选电极的目标电压,则在步骤1306处,确定主电极的目标电压是否大于零。如果不是,则在1308处,RF发生器的输出电压对于该治疗循环设置成在1304处确定的最低目标电压,用于其它候选电极。如果在1304处对主电极确定的目标电压大于零,则在1310处,RF发生器的输出电压对于该治疗循环设置成主电极的目标电压。
在步骤1312处,具有大于零的目标电压的主电极和其它候选电极识别为待激励的电极。在备选实施例中,如果对那些电极确定的目标电压比设置电压大6V,则将仅激励除主电极之外的候选电极。
在又一些实施例中,如果对这些电极确定的目标电压比设置电压大1V、5V或10V,则将仅激励除主电极之外的目标电极。
在步骤1314处,确定待激励的电极目前是否处于大于68℃的温度。处于大于68℃的温度的那些电极切断或另外防止在该治疗循环中被激励,并且在步骤1316处在设置电压下激励另外满足以上标准的那些电极。随后,另一个治疗循环开始,并且图13的控制环重复,直到治疗完成。在一些实施例中,各个治疗循环将不与之前和下一个循环重叠(例如,图13的步骤将在下一个循环步骤开始之前完全执行),但在其它实施例中,循环可至少在一定程度上重叠。
图16-23为使用用于肾去神经的Vessix系统的治疗的在一定时间内的温度(目标和实际)和目标电压的图表,该治疗使用图13的控制环来将装置的八个电极处的实际温度调节至目标温度曲线。应当理解,这些图中标出的目标电压与施加至电极的实际电压不同,因为如上文所述,电极中的仅一个的目标电压用于设置各个治疗循环中施加的实际电压。如图16-23中所示,图13的控制环作用为将装置的各个电极处的实际温度精确地保持在目标温度下。还如图16-23中所示,测量的阻抗可在一些情况下在治疗过程中(特别是在治疗开始时)下降,反映了组织中的离子响应于高频RF能量的机动性提高。
已经以实验确定了上文所述的温度控制方法的示例性实施例在用作肾去神经的Vessix系统的一部分时,提供降肾上腺素(NEPI)浓度的有效降低。在一个实验中,用于肾去神经的Vessix系统的效力和安全性在健康的约克夏幼猪中在治疗后的第7天和第28天评估,包括评估治疗后第7天的肾脏NEPI浓度水平。图25为归纳该特定实验的研究设计的表格。组1和2的效力测量为第7天的各个动物中的治疗的动脉对未治疗的对侧控制肾脏中的NEPI水平的百分比减小。图26示出了两组(作为平均值+/-SD)的NEPI百分比减小。在研究过程内,在任何动物中,身体重量、身体状态分数或临床病理学参数没有显著变化。总体上,平均基准脉管直径在穿过所有时间点的组之间类似。在相比于未治疗的动物的脉管时,管腔获得或损失计算(平均尸体剖验前,平均基准直径)和呈现为类似于治疗的脉管的管腔获得。图27-30中示出了RF治疗后的第7天和第28天的肾动脉预治疗的代表性血管造影图像。经由血管造影分析,没有检测到急性的或慢性的穿孔、切口、血栓或栓塞。
e.
神经信号刺激和监测
在上述实施例中的至少一些中或在备选实施例中,肾去神经治疗方法和系统可提供神经信号的刺激和对治疗的肾动脉近侧的组织中的神经信号反应的监测。在一些情况下,神经活动的该电记录图可提供去神经治疗的效力的评估并且/或者提供调节治疗的反馈。在至少一些实施例中,此类电记录图提供了神经活动是否存在和/或关于测量基准转移(例如,减小)的评估,并且不涉及肾动脉近侧的神经组织的存在的映射或量化。
在一个实施例中,用于输送去神经治疗的相同电极组件(诸如图1C中所示的近侧电极极板150a-d和远侧电极极板170a-d上的双极电极对)还可构造用于刺激神经信号和监测神经信号反应。例如,近侧电极极板150a-d中的一个上的近侧双极电极对中的一个可用于刺激神经信号,而远侧电极极板170a-d中的一个上的远侧双极电极对中的一个可用于监测神经信号反应。作为备选,远侧双极电极可用于刺激,并且近侧双极电极可用于监测。在这些或其它实施例中,刺激和感测可通过轴向或周向相邻的电极对执行。
具有上文在图2A的背景下描述的尺寸、间距、其它几何形状和其它特性的电极222可足以刺激和监测神经信号,但在备选实施例中,电极还可进一步减小尺寸,并且/或者其它特性可改变成提供较高的信号分辨率。本文所述的系统和装置的其它改型还可制作成最小化神经信号的刺激和(特别是)监测的干扰。例如,在一些实施例中,系统的电路(诸如,RF发生器的内部电路)的布局和/或与导管/柔性电路相关联的布线的配对、扭曲和其它特性可优化来减小电路的内部电容,以提供减小的电磁通量。
在备选实施例中,用于刺激和/或监测神经信号的电极可不同于用于输送能量治疗的电极。刺激/监测电极可具有优化用于刺激/监测的位置、几何形状和其它特性,并且能量输送电极可具有优化用于输送能量治疗的位置、几何形状和其它特性。图42示出了包括用于输送能量治疗的电极(类似于图10中的电极)和用于神经信号的刺激和监测的单独的电极(这里,呈可扩张装置的远端和近端上的周向环形电极的形式)的导管的实例。图43示出了包括承载用于刺激和监测神经信号的环形电极的单独的近侧和远侧可扩张装置的导管的实例。图42和43的电极均可为双极电极、单极电极,或者可构成近侧电极环与远侧电极环之间的双极电极。如图24D中所示,电极的简化示意图可在用户界面上示出,以识别可用于激励的电极区域,并且还可包括通过阻抗的测量来对充分组织并列指示。由于用户界面可以以示意性形式示出电极构造,故应当理解,示意性图像不应当限于存在于可扩张结构上的电极构造的类型。电极可为环、双极对、点电极、轴向长形电极等中的任一个或更多个。
在单极实施例中,电极用作用于在治疗期间刺激和感测的阳极,而单独的阴极用作接地。阴极可位于可扩张结构上,在导管本体上的一个或更多个点处,或以接地极板形式在患者外。在单极构造中,信号处理和滤波(如下文进一步所述)是合乎需要的选项,这是由于能量输送与神经反应检测之间的大小相对大的差异。
对于图1A所示和所述的控制单元110的RF发生器和其它电路可用于生成神经刺激信号并且监测反应,但在其它实施例中,单独的装置可与用于生成神经刺激和/或监测反应的系统相关联。
在一个实施例中,神经刺激可为在大约0.1V到大约5V或大约0.5V的范围内的电压,其由第一电极施加大约1秒或更短或大约0.5毫秒的周期,随后是脉宽调制,该电压可冲击神经组织来传播神经信号。脉冲信号可为任何形式,其中方波为一个示例性形式,因为波形的快速开/关性质有效地刺激了没有缓升或从峰值电压的神经反应。
神经活动可通过测量响应于刺激的神经信号的振幅、响应于刺激的神经信号的速度和/或神经信号的分级振幅中的一个或更多个来评估。这里,分级振幅是指相比于治疗前的基准的、神经传导信号的净减小和变化。治疗前的信号可预计为具有相对较大的振幅和较平滑斜率过渡,而来自接受至少一些治疗的神经的信号将预计具有相对较低的振幅和指示由于治疗而引起的中断神经传导的在斜率上的较不平滑的、突然的或中断的过渡。这些测量结果可通过测量第二电极处的电压变化和/或刺激与反应之间的测量时间来确定,并且在至少一些实施例中,可使用高通和/或低通滤波来将神经信号与背景噪音区分开。
目前,介入性能量输送疗法(诸如肾去神经)基于解剖学标记来执行。在肾去神经的实例中,已知的是大部分神经沿肾动脉的长度定位。治疗后评估基于次级效应(诸如NEPI和血压降低),其典型地不是立即的指示物,并且不指示神经生活力。
在当前技术水平下,不存在可用于在肾去神经程序期间直接实时评估肾神经的功能行为的手段。该问题的解决方案为使用交流电流或直流电流来在肾动脉内的肾神经附近输送子阈值或低刺激信号,以存取它们在肾去神经治疗之前和之后的活动。
高分辨率快速神经生活力测量可经由多个局部电极(诸如图1B和1C中所示的那些)来完成,然而,应当注意,实施例不限于球囊上的双极柔性电路电极。可使用适于安装于基于导管的可扩张结构的任何电极构造(单极或双极);环形电极、线性或螺旋电极、点电极等可安装于笼、球囊,或用于导管系统中的任何其它此类类型的结构。
测量技术使用来自神经路径之上的至少一个电极的电刺激来引起动作电势的生成,该动作电势沿兴奋的神经纤维传播。该动作电势接着记录在另一个点上。该技术可用于确定神经脉动的传导的充分性,因为其路线沿神经,从而检测神经损害的迹象。电极之间的距离和电脉动在电极之间行进所花费的时间用于计算脉动传输的速度(神经传导速度)。传输速度下降指示神经伤害。
在肾神经的电刺激之后的反应的速度、振幅和形状将经由球囊导管上的多个电极测量。异常发现包括传导缓慢、传导阻塞、缺少反应和/或低振幅反应。参照图44和45,电信号形态指示神经传导中的变化,如由与缓慢传导组合的分级程度中的变化证实。图44示出了治疗前或基准状态中的代表性神经信号4401。图45示出了在接受至少一些能量治疗之后的代表性神经信号4501。当将信号4401与信号4501相比较时,清楚的是,神经信号的振幅已经减小,同时脉宽增大。还清楚的是,信号4501的斜率和斜率变化比信号4401的斜率和斜率变化更平滑。这指示了神经如何响应于本公开的能量治疗;当输送能量时,神经传导性质降低或消除,从而引起神经信号减小、较不连续并且速度较慢。
神经信号测量可使用信号滤波来优化,使得心脏电信号、刺激信号和系统噪音的影响被滤出神经感测电路,以便优化电路的准确性和敏感性。信号滤波可通过诸如带通滤波器的器件来实现。例如,具有100Hz的示例性值的在大约1Hz到大约500Hz的范围内的低通滤波器和具有5kHz的示例性值的在大约1kHz到大约10kHz的范围内的高通滤波器可用于建立待由电路感测和测量的信号的频带。测量结果接着用作施加于能量控制算法的反馈,该能量控制算法用于调节疗法能量的输送。
在单极实施例中,感测来自组织的较宽的场,因为能量从电极的一个或更多个阳极流至公共接地路径的阴极或多个阴极。将该构想应用于图1B和1C的实施例,示例性极性将使用外部补片(未示出)作为阳极,而电极组件140a-d用作用于神经信号测量的公共接地电路的阴极。在能量的用于感测目的该表面上向后施加中,电极组件140a-d更邻近感兴趣的神经组织,并且因此可通过用作阴极来用于感测而提供改进的感测准确性。在治疗的能量输送模式期间,外部补片和电极组件140a-d的极性可切换,使得电极组件140a-d为阳极,而外部补片为阴极用于接地。
在双极实施例中,感测来自组织的局部场,因为电极组件140a-d的阳极和阴极紧邻,并且因此感测的组织体积比在单极构造中更加局部。双极布置中的电极的紧邻可为合乎需要的,因为极的接近允许固有较低量的能量输送来激励组织,以及由于极之间的较小组织体积而引起的固有较高程度的测量分辨率。此外,电极组件140a-d的构造提供近侧/远侧线性间距,这允许了神经信号沿路径的线性行进的感测和测量,如已在本文中描述的。
神经信号刺激和测量可在能量治疗之前、期间和/或之后发生。在一个实施例中,在治疗之前评估神经活动来建立神经活动的基准水平,并且接着在治疗之后再评估来确定肾活动中的阈值水平的变化是否得到。神经信号振幅中的百分比减小、信号斜率的分级程度、神经信号脉冲的持续时间的增大,以及神经信号脉冲之间的时间增加中的任一个或更多个可用于测量组织反应,其指示了目标组织中的去神经已发生或在发生的过程中。换言之,神经活动的全部中断可为去神经治疗的延迟反应,但神经活动的一些减少可在去神经治疗期间或之后不久发生,足以指示治疗的有效性。在备选实施例中,有效去神经的特征可为其中没有检测到响应于预定刺激的神经信号的有效去神经。
神经信号评估还可或作为备选在能量治疗期间传导。例如,图13中所示的控制算法可改变以允许各个电极激发循环之前或之后的刺激神经活动的时间规模测量结果(此类测量结果大约为毫秒、微秒、毫微秒、皮秒等中的任一个)。这些循环内测量结果可相比于治疗前基准、来自早期循环的测量结果或其它标准。
在一些实施例中,不管神经活动评估是否在治疗前和治疗后进行,在各个治疗循环之间定期进行,或在一定数量的治疗循环之后定期进行,来自神经活动评估的数据可用于建立或调整去神经治疗的参数。例如,在图13和图14所示的实施例中,尽管各个循环的设置电压可为应用和测量的前述电压和平均温度误差的函数,但治疗温度下的总时间可为测量的肾活动的函数,或与早期测量或预置的基准的测量神经活动的偏差的函数。在该类算法中可解决神经信号的测量振幅、神经信号的速度和/或分级振幅中的一个或更多个。因此,如果神经活动的显著减少在去神经治疗的早期测量到,则可缩短总治疗时间。相反,如果神经信号评估并未测量神经活动的减少,则可延长总治疗时间。当然,来自(多次)神经信号评估的反馈可用于改变去神经治疗的附加或备选参数。
测量神经信号可直接集成到本文所述的能量输送和控制方法中。当根据控制算法选择和激励候选电极时,神经信号测量的附加功能可集成到控制算法中,使得神经反应的附加控制因素提高输送能量的精度,并且实现疗法反应,同时避免输送过多能量,以便最大可能程度地保存治疗前问题细胞状态。如图13A中所示,附加控制环步骤1313可用于评价是否已经满足神经信号减小阈值。如果未满足神经信号减小阈值,则控制环接着前移到环步骤1314,以确定候选电极是否达到温度阈值。如果在环步骤1313处,确定神经达到信号减小阈值,则电极可取消作为待激励的候选电极。
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分支脉管及其它通路的治疗
本文所述的系统和装置可有利地用于其它基于能量的治疗系统和装置将不适合的情形中。例如,本文所述的系统和装置的实施例可用于太小而不能使用其它基于导管的能量治疗系统治疗的脉管和其它通路中。在一些情况下,本文所述的系统和装置可用于具有小于4mm的直径和/或小于20mm的长度的肾动脉或其它脉管中。其它因素(诸如脉管曲折和治疗部位邻近将不接受治疗的区域)可为使用早先的装置的治疗的相反指示,或另外不适用于使用早先的装置的治疗,而非目前描述的系统和装置的至少一些实施例。
图1D和E示出了各个具有三个电极组件的4mm和5mm的球囊。然而,这些电极组件的特定几何形状和之前段落中描述的其它特性便于它们用于较小直径的球囊上,诸如,1mm、2mm或3mm的球囊或其中间尺寸。在一些情况下(诸如,在一些1mm的实施例中),球囊可不包括导线管腔。图46示出了具有主体4601的球囊的一个实施例,其由DuPont™市售的Kapton®柔性聚酰亚胺膜制成,其中肩部4602由标准球囊材料制成。在一些情况下,图46的球囊的Kapton®本体可用于消除用在球囊上的柔性电路组件的单独层的需要,以便消除图2B中所示的底座层202,从而减小柔性电路组件的轮廓。
上文所述的系统和装置的其它特征还可便于它们在相对小的脉管中使用。例如,输送能量治疗至较小直径的脉管可需要对输送的能量和/或由治疗引起的温度升高的特别精密的控制。就此而言,上文所述的特定电极能量输送几何形状、控制算法和其它特征可使本系统和装置特别适于此类情形。
图47示意性地示出了从主动脉4702分叉至肾脏4703的典型主肾动脉4701。示出了本公开的实施例,其中导管的球囊和电极组件4704扩张并且定位用于治疗组织。施加能量剂量,并且球囊随后泄放并且除去或重新定位。
图48示意性地示出了从主动脉4803分叉的主肾动脉4801和副肾动脉4802,其中两者延伸至肾脏4804。副动脉的尺寸范围可从大约1mm直径至大约5mm直径。图48的肾动脉应当理解为其可从受验者到受验者在体内不同的简单简图。例如,动脉可在直径、长度、曲折性、位置和数量上变化。此外,这些变化可关于各个动脉以及关于各个受验者。图48示出了定位用于在较小副动脉中治疗的第一球囊导管A,以及定位用于在较大主肾动脉中治疗的第二球囊导管B。
实际上,如果两个动脉的直径足够接近以允许完全球囊扩张和与动脉管腔的组织接触,则有可能的是导管A和导管B为相同的一个。还有可能的是,导管A和导管B可取决于各个动脉的可治疗长度沿相应的动脉的长度重新定位。还有可能的是,主动脉和副动脉可同时治疗(如果医生这样期望)。
如申请人所知,在本公开之前,副肾动脉的治疗由于由小动脉的过热、在具有较小截面的管腔区域中操作时的空间约束,以及曲折通径的导航的难度引起的技术限制而为不可能的。由于本公开的实施例使用可扩张的基于导管的结构、球囊上的柔性电路电极,故"一个尺寸配合所有"的装置的限制被排除。本公开的球囊和电极组件尺寸渐增,并且布置成便于精确控制热能剂量用于管腔直径的渐增范围。换言之,球囊和电极组件尺寸渐增并且布置用于优化对应尺寸的管腔中的操作。电极的数量选择成避免组织的过热。基于球囊的可扩张结构能够在较小的未扩张直径下利用柔性导航至一位置。扩张球囊的较大表面接触允许组织接触的一致性,同时避免了单个点探头或其它此类类似设计的弯曲和/或紧密的空间约束。
副肾动脉存在于25%到30%的人类患者中;然而,这些患者已经从之前肾去神经研究中排除。在REDUCE-HTN临床研究(Vessix Vascular临床研究协议CRO
12-020的全部内容通过引用并入本文中)内,四个受验者的子集经受使用Vessix去神经系统(Vessix Vascular, Inc.; Laguna Hills, CA)的主肾动脉和至少一个副肾动脉的成功治疗,该Vessix去神经系统包括0.014英寸的线上经皮球囊导管,其具有以沿纵向和沿周向偏离的图案安装在球囊表面上的高达8个不透辐射的金电极。在示例性实施例中,导管连接于专有自动低功率RF双极发生器,其在大约68℃下输送温度受控的疗法剂量的RF能量大约30秒。该群的平均基准基于办公室的血压(OBP)为189/94mmHg。除各个主肾动脉的10.5次去神经的平均值外,该群以每个副肾动脉8次去神经的平均值治疗。
在该研究中,对于四个受验者,没有报告外周程序并发症,并且立即在程序后的血管造影指示了没有肾动脉痉挛或任何其它有害效应。这四个受验者证实在程序后两星期的改进,其中OBP的平均减小为-32/-16mmHg(190/97到167/91;175/92到129/70;192/94到179/91;183/87到138/55)。
图49和50示意性地示出了肾去神经治疗的非限制性实例,其中能量输送有选择地使用电极组件的电极的子集来输送。图49示意性地示出了肾动脉4901,其包括分支4902。在该情况下,球囊和电极组件4903定位在肾动脉中,使得电极中的一个4904邻近将分支连结于肾动脉的口,并且因此不与管壁并列。如上文在一些实施例中所述,根据本公开的系统和方法可构造成有选择地激励电极或与管壁并列的电极的子集(例如,图49中的电极4905和4906),而不激励并未与管壁并列的电极或电极子集(例如,电极4904)。本领域的技术人员将认识到,除图49的实例之外,多种其它因素可导致电极组件与管壁之间的低于完全的并列,包括而不限于脉管曲折、脉管直径变化、存在或没有管壁上的累积等。
图50A和B示意性地示出了肾去神经治疗的非限制性实例,其中利用在肾动脉5001中的两个位置处的电极组件和球囊来执行能量治疗。在图50A中,球囊定位成使得所有电极5002-5005位于肾动脉5001中,并且为用于激励的潜在候选。在图50B中,在图50A中所示的位置处执行能量治疗之后,球囊和电极组件被取回,使得其一部分仍在肾动脉5001中,并且其一部分在主动脉5006中。在图50B中所示的定位中,本公开的系统和方法的一些实施例将构造成仅选择电极5002和5005(和定位在肾动脉5001内且/或与肾动脉5001的壁并列的任何其它电极)作为用于激励的潜在候选,其中主动脉5006中的电极识别为用于激励的非候选。如图50A和B所示,本公开的某些实施例可便于将能量输送至将主动脉5006连结于肾动脉5001的口处或近侧的组织,其可在至少一些患者中是神经组织的相对高集中的区域。
尽管经由实例和为了理解的清楚而详细描述了示例性实施例,但本领域的技术人员将认识可使用多种改型、适应和变化。
Claims (12)
1. 一种肾去神经治疗系统,包括:
(a)包括所述导管的远端处或附近的可扩张结构的长形导管,所述可扩张结构包括多个电极;
(b)电性地联接于所述多个电极的电源;以及
(c)处理器,其构造成(1)在肾去神经能量水平下激励所述电极的至少一个子集;(2)在神经活动刺激水平下激励所述电极中的一个或更多个;并且(3)使用所述导管中的一个或更多个监测神经活动反应。
2. 根据权利要求1所述的系统,其特征在于,所述神经活动刺激水平为施加大约1秒或更短的在大约0.1V到大约0.5V的范围中的电压。
3. 根据权利要求2所述的方法,其特征在于,所述神经活动刺激水平为施加大约0.5毫秒的大约0.5V。
4. 一种医疗装置系统,包括:
医疗装置,其构造用于:
(a)将第一神经活动刺激施加于肾去神经系统的导管组件近侧的组织;
(b)使用所述导管组件测量所述组织的第一刺激神经活动反应;
(c)使用所述导管组件将能量治疗输送至所述肾动脉近侧的所述组织;
(d)使用所述导管组件测量所述肾组织的第二神经活动反应;以及
(e)通过比较所述第一测量神经活动和所述第二测量神经活动来确定所述能量治疗的参数。
5. 一种医疗装置系统,包括:
医疗装置,其构造用于:
使用所述导管组件将肾活动刺激施加于肾动脉近侧的目标组织;
使用所述导管组件评估所述组织的刺激神经活动反应;
其中评估所述神经活动包括至少进行第一神经活动测量和第二神经活动测量;
其中进行所述第一神经活动测量包括在开始将RF能量治疗输送至所述目标组织之前进行所述第一神经活动测量,形成基准神经活动测量结果;
其中进行所述第二神经活动测量包括在开始输送所述RF能量治疗之后进行所述第二神经活动测量;
确定神经活动是否从所述基准变化;
输出关于所述评估的神经活动的数据;并且
其中输出数据包括输出是否出现神经活动的充分减少。
6. 根据权利要求5所述的医疗装置,其特征在于,确定神经活动是否从所述基准变化包括确定神经活动中的所述变化是否处于、高于或低于阈值。
7. 根据权利要求6所述的医疗装置,其特征在于,还包括一旦神经活动的所述变化处于或高于所述阈值,则终止所述RF能量治疗。
8. 根据权利要求5至权利要求7中任一项所述的医疗装置,其特征在于,评估刺激神经活动反应包括在所述RF能量治疗期间周期地测量刺激神经活动反应。
9. 根据权利要求5至权利要求8中任一项所述的医疗装置,其特征在于,施加神经活动刺激包括激励所述导管组件的至少一个电极;并且其中评估刺激神经活动反应包括使用所述导管组件的第二电极来监测所述神经反应信号。
10. 根据权利要求5至权利要求9中任一项所述的医疗装置,其特征在于,确定所述RF能量治疗的至少一个参数包括基于所述评估的神经活动调整所述至少一个参数。
11. 根据权利要求10所述的医疗装置,其特征在于,调整所述至少一个参数包括调整所述RF能量治疗的温度曲线。
12. 根据权利要求10所述的医疗装置,其特征在于,调整所述至少一个参数包括调整所述目标温度曲线的目标温度下的时间长度。
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