CN104135958A - 用有聚合物消融元件的新消融导管调变神经的装置和方法 - Google Patents
用有聚合物消融元件的新消融导管调变神经的装置和方法 Download PDFInfo
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Abstract
本公开涉及用于神经调变的血管内导管,其包括:具有近侧端和远侧端的伸长部件;具有内腔和囊壁的囊,囊壁包括RF可穿透区段和不导电区段;设置在囊内且向远侧延伸到最远侧的RF可穿透区段的电极。RF可穿透区段可包括多个RF可穿透窗,各个窗具有的周向尺寸比轴向尺寸更大。血管内系统适于对肾神经进行调变。
Description
与相关申请的交叉引用
本申请在35 U.S.C§119下要求2011年12月28日提交的美国临时申请No.61/580,972、2012年10月3月1日提交的美国临时申请No.61/605,615和2012年10月3月1日提交的美国临时申请No.61/605,624的优先权,它们通过引用而结合在本文中。
技术领域
本发明大体涉及用于进行神经调变(modulation)和/或消融的经皮和血管内装置。
背景技术
某些处理需要临时或永久地中断或修改选定的神经功能。一个示例处理为肾神经消融,其有时用来处理与充血性心脏故障相关的状况。肾会对充血性心脏故障产生交感响应,除了其它作用之外,这会提高水和/或钠的不合需要的滞留。消融一些延伸到肾的神经可减少或消除这个交感功能,这可对应地减少相关联的不合需要的症状。
许多身体组织,诸如神经(包括肾神经)、脑组织、心脏组织和其它身体器官的组织紧邻血管或其它身体腔体,并且因而可通过血管的壁经皮或在血管内接近。在一些情况下,可为合乎需要的是使用射频(RF)电极来消融血管周神经。在其它情况下,周血管神经可通过其它手段消融,包括对血管壁施加热、超声、激光、微波和其它相关能量源。
在涉及诸如肾神经的血管周神经的处理中,采用这样的能量源的处理方法往往将能量施加为大体周向环,以确保神经得到调变。但是,这种处理可导致电极附近的血管壁有热损伤,以及导致其它不合需要的副作用,诸如(但不限于),血损害、凝结、血管壁被消弱和/或电极的蛋白质结垢。
发明内容
因此合乎需要的是提供一种备选系统和方法,用于进行沿着和围绕血管或其它身体腔体分配消融或调变位点的组织处理,诸如血管内神经调变处理。
本发明的一些实施例涉及一种囊导管,其构造成进行组织调变,诸如神经调变和/或消融。囊导管包括在装置的远侧端处或附近的可膨胀的囊。囊的壁构造成允许诸如RF能量的电在某些位置处通过以及阻止RF能量或电在其它位置处穿过。电极延伸通过囊的内腔,以供应电或RF能量。在使用中,用传导性流体诸如盐水使囊膨胀,并且囊定位在用于处理的期望的位置处。在一些实施例中,囊可在处理位置处沿周向接触壁,诸如血管壁。电极被激活,并且RF能量传递通过传导性流体且通过RF可穿透的位置离开囊,以对组织进行调变或消融。
囊可为多层囊,其具有由RF可穿透材料制成的第一层和由电绝缘材料制成的第二层。RF可穿透材料可例如亲水性聚氨酯,而电绝缘材料可例如为(非亲水性)聚氨酯。允许RF能量透过的位置或窗不包括电绝缘材料。这些RF可穿透材料制成的这些囊壁可由单层RF可穿透材料形成,而囊的其余部分可具有两个层,一个为RF可穿透材料制成,而一个为电绝缘材料制成。
囊导管可包括其它元件,诸如多内腔导管轴。多内腔导管轴可包括引导线内腔和一个或两个流体内腔,以及传导性部件,传导性部件将电极和一个或多个传感器连接到功率和控制系统上。对于包括两个流体内腔的实施例,一个流体内腔可用来将传导性流体引入囊中,而另一个流体内腔可用来从囊排空传导性流体。以这个方式,传导性流体可在囊内循环。在一些实施例中,流体吸入内腔具有流体入口,其在远侧位置处流体地连接到囊中的囊内腔上,并且流体出口内腔具有流体出口,流体出口在较近侧位置处流体地连接到囊中的囊内腔上。
电极可为任何适当的电极部件,并且可例如为带状电极,带状电极螺旋地缠绕在囊内腔内的导管轴周围,并且可由任何适当的材料制成,诸如铂。
一个说明性实施例具有囊,其具有通过囊壁的三个、四个或更多个RF可穿透窗。窗可为圆形、矩圆形、钻石形、蝶形领结形或另一个适当的形状,并且沿纵向和沿周向间隔开。优选地,窗布置成使得接收组织调变或消融处理的处理区域提供期望的覆盖范围。例如,在一些实施例中,窗布置成使得沿纵向沿着囊壁画出的任何线穿过至少一个窗。这种窗布置允许覆盖血管的周边周围,同时仍然容许窗沿纵向间隔开。在其它实施例中,一个或多个窗布置成使得沿纵向沿着囊壁画出的线穿过两个窗的一部分。在其它实施例中,窗的数量和布置使得沿纵向沿着囊壁画出的任何线穿过至少两个窗。
另一个说明性实施例包括沿着囊的长度或沿着囊的长度的一部分的一个或多个螺旋形窗。另一个说明性实施例包括沿周向围绕囊延伸的一个或多个窗。
另一个说明性实施例包括螺旋形囊,其中,囊内腔为螺旋形且包绕在导管轴周围。在这个实施例中,一个或多个窗可定位在囊导管的外直径上且布置成使得沿纵向(即平行于导管轴)沿着囊壁的外直径画出的任何线穿过至少一个窗。在一个说明性实施例中,螺旋形窗沿着螺旋形囊的外直径延伸。
在另一个说明性实施例中,囊的RF可穿透部分比电绝缘部分的柔性更高,并且传导性流体所提供的压力可使窗突出。囊的不同的部分在相对柔性方面的这样的差异可通过材料的选择、硬度的选择、通过改变层的厚度或层的一部分的厚度或通过其它适当的方法来实现。
在另一个说明性实施例中,窗模制成延伸出囊壁超过电绝缘材料。
在一个说明性使用方法中,使用引导线、引导导管或其它传统的手段将根据本发明的实施例的囊导管经皮和/或在血管内插入到处理位置。利用传导性流体来使囊膨胀,并且传导性流体在囊内循环。电极被激活且RF能量从电极传递通过传导性流体和RF可穿透窗而进入期望的处理区域的组织。处理可在预先确定的时间之后或在满足预先确定的条件之后结束。例如,可通过电极测量阻抗,并且处理可在测量到的阻抗有预先确定的变化之后结束。
一些示例实施例的上面的概述不意图描述本发明的各个公开的实施例或每一个实现。
附图说明
在结合附图来考虑各种实施例的以下详细描述时,可更完整地理解本发明,其中:
图1是示出在现场的肾神经调变系统的示意图。
图2是示出肾神经调变系统的远侧端的示意图。
图3是图2的肾神经调变系统的横截面图。
图4是图2的肾神经调变系统的另一个横截面图。
图5是示出在现场的图2的肾神经调变系统的示意图。
图6是肾神经调变系统的示意图。
图7是肾神经调变系统的示意图。
图8是肾神经调变系统的示意图。
图9是肾神经调变系统的示意图。
图10a是肾神经调变系统的示意图。
图10b是图10a的肾神经调变系统的示意图。
图11a-11d是肾神经调变系统的示例囊的外表面的透视图。
虽然本发明可修改成有各种修改和备选形式,但是它们的细节已经以示例的方式显示在图中且将详细描述。但是,应当理解,不意图将本发明的各方面限于描述的特定实施例。相反,意图覆盖落在本发明的精神和范围内的所有修改、等效方案和备选方案。
具体实施方式
以下描述应当参照附图来阅读,其中,相同参考标号在所有图中表示相同的元件。图未必按比例绘制,图不意图限制要求保护的发明的范围。详细描述和图示出要求保护的发明的示例实施例。
所有数量在本文假设为由用语“大约”修饰。由端点所阐述的数字范围包括包含在那个范围内的所有数量(例如、1至5包括1、1.5、2、2.75、3、3.80、4和5)。
如这个说明书和所附权利要求中使用,单数形式“一个”、“一种”和“该”包括复数个参考对象,除非内容清楚地有其它规定。如这个说明书和所附权利要求中使用,用语“或”大体在其包括“和/或”的意义上使用,除非内容清楚地有其它规定。
注意,说明书中对“实施例”、“一些实施例”、“其它实施例”等的参照表示描述的实施例可包括特定特征、结构或特性,但是每个实施例可能不必包括特定特征、结构或特性。此外,这样的短语不必参照同一实施例。另外,当结合实施例描述特定特征、结构或特性时,结合其它实施例来实现这种特征、结构或特性将在本领域技术人员的知识范围内,而不管是否清楚地描述,除非清楚地有相反的陈述。
虽然本文描述的装置和方法关于通过血管壁的肾神经调变来论述,但是构想到是,装置和方法可用于其中期望进行神经调变和/或消融的其它应用中。用语调变表示可改变被影响的神经和其它组织(诸如脑组织或心脏组织)的功能的消融和其它技术。当期望多次消融时,它们可由单个消融装置连续执行。
图1是在现场的说明性肾神经调变系统的示意图。系统10可包括一个或多个传导性元件16,以对肾消融系统提供功率,肾消融系统包括设置在输送鞘14内的肾神经调变装置12,当伸长部件的沿径向扩张的区域(未显示)处于非扩张构造时,输送鞘14可适于可滑动地容纳肾神经调变装置12,其细节可更好地在后续的图中看到。传导性元件16的近侧端可连接到控制和功率元件18上,控制和功率元件18供应必要的电能,以激活一个或多个电极, 线材16的远侧端在肾神经调变装置12的远侧端处或附近附连到电极上。当适当地激活时,电极能够消融组织,如下面所描述。在后面的公开中,用语电极可看作等效于能够消融相邻组织的元件。用于输送鞘14、伸长部件12和能够消融相邻组织的元件的适当的材料在本领域中是已知的,并且在一些实施例中,可包括内润滑材料层和/或外润滑材料层。在一些情况下,返回电极贴片20可设置在腿上,或在患者的身体上的另一个传统的位置处,以完成电路。还可包括近侧毂(未示出),其具有用于引导线的端口、膨胀内腔和返回内腔。
控制和功率元件18可包括监测元件,其利用沿着肾神经调变装置12安装的传感器以及用于执行期望的过程适当的控制器来监测参数,诸如功率、温度、电压、脉冲大小、阻抗和/或形状和其它适当的参数。在一些实施例中,功率元件18可控制射频(RF)电极。电极可构造成在大约460kHz的频率下运行。构想到时,可使用在例如450-500kHz 的RF范围中的任何期望的频率。另外构想到的是,可如期望的那样使用其它消融装置,例如(但不限于)电阻加热、超声、微波和激光装置,并且这些装置可能需要功率元件18以不同的形式供应功率。
图2示出肾神经调变装置12的远侧部分。肾神经调变装置12包括囊22和电极24。当在使用中,优选对囊填充传导性流体26,诸如盐水,以允许消融能量从电极24传递通过RF辐射可穿透的窗28。其它适当的传导性流体包括高渗溶液、对比溶液和盐水或高渗盐溶液与对比溶液的混合物。传导性流体可通过中心轴34中的流体入口30引入和通过中心轴34中的流体出口32排出。可包括一个或多个传感器50,诸如热电偶,并且其可设置在轴34上、在囊22上或在另一个适当的位置处。
在图3中示出肾神经调变装置12的轴34在囊的近侧的横截面图。轴34可包括引导线内腔36、连接到流体出口30上的内腔38,以及连接到流体入口32上的内腔40。电极24或将功率供应到电极的传导性元件可沿着轴的外表面延伸或可嵌在轴内。电极24在囊的近侧优选是电绝缘的且用来将功率传递到电极的设置在囊中的部分。在图3中示出两个导体42,其可用来供应功率和允许信息从一个或多个传感器50返回。在一些实施例中,可省略引导线内腔和/或一个流体内腔38、40。在一些实施例中,引导线内腔从装置的远侧端延伸到近侧毂。在其它实施例中,引导线内腔可具有近侧开口,其在系统的近侧部分的远侧。在一些实施例中,流体内腔38、40可连接到使流体循环通过囊22的系统上或供应新的流体且收集排出的流体的系统上。可理解,实施例可仅靠单个流体入口内腔和进入囊的单个流体出口起作用。还可理解的是,构想到其它内腔构造。例如,三个内腔可设置在彼此内或可同心。引导线内腔可为最内部内腔且可由流体入口内腔包围,流体入口内腔又可被流体出口内腔包围。在另一个构想到的实施例中,流体入口和流体出口内腔中的仅一个围绕引导线内腔而设置,并且流体入口和流体出口内腔中的另一个与引导线内腔平行地延伸且与引导线内腔间隔开。另一个构想到的实施例缺乏流体出口内腔,并且流体入口内腔围绕引导线内腔或同心地围绕引导线内腔而设置。在另一个构想到的实施例中,引导线内腔被省略,并且系统包括仅流体入口内腔或仅流体入口和出口内腔。
图4中示出轴34在流体出口32的远侧的横截面图。存在引导线内腔36和流体入口内腔36,以及电极24。在当前示出的实施例中,连接到一个或多个传感器50上的导体42不存在于这个横截面图中。可理解到,在具有一个或多个远侧传感器的实施例中,可存在一个或多个导体42,以与它们连接。
在横截面中显示囊22具有第一层44和第二层46。窗28形成于囊22中,由于缺乏第二层46。第一层44优选由RF可穿透材料制成。一种适当的材料为亲水性聚氨酯。其它适当的材料包括其它亲水性聚合物,诸如亲水性皮巴克斯(Pebax)、亲水性尼龙、亲水性聚酯或具有亲水性嵌段的嵌段共聚物。适当的亲水性皮巴克斯级可包括皮巴克斯 MV1074、皮巴克斯 MV 1041、皮巴克斯 MP 1878、皮巴克斯 MV-3000和皮巴克斯 MH-1657。在一些实施例中,一种或多种亲水性聚合物(诸如亲水性皮巴克斯)与用于囊中的其它聚合物混合使用,诸如皮巴克斯 6333、皮巴克斯 7033、皮巴克斯 7233、尼龙 12、维斯塔米德(Vestamid) L2101F、格里拉米德(Grilamid) L20和格里拉米德 L25。适当的亲水性聚合物可展现6%至120%的亲水性(或水吸收量百分比)、20%至50%的亲水性或其它适当的范围。第二层46优选由不导电聚合物制成,诸如非亲水性聚氨酯、皮巴克斯、尼龙、聚酯或嵌段聚合物。其它适当的材料包括一定范围的不导电聚合物中的任一种。第一层和第二层的材料可选择成在两个层之间具有良好的粘结特性。例如,囊22可由亲水性皮巴克斯制成的第一层44和常规或非亲水性皮巴克斯制成的第二层46形成。在其它实施例中,适当的粘结层(未示出)可设置在两个层之间。
图5示出在现场的装置12的远侧端。优选地,可获得各种尺寸的装置12,并且选择的尺寸将允许囊22的窗28接触血管48的壁。囊优选略微有柔性,使得具有标称直径4mm的囊可扩张成配合3.5mm和5mm之间的血管。
图5中示出的特定囊可适于用于肾神经调变应用中。肾神经大体沿纵向围绕肾动脉的外部延伸。这表示人们可改变任何特定周向处理的纵向位置,以及实现相同的神经调变作用。因而窗28布置成实现血管的完全周向覆盖,同时沿纵向间隔开。在这个特定情况下,四个窗28各自覆盖血管的不同的90度弧。各个窗可覆盖不止90度弧。例如,窗28可覆盖100或110度弧,以允许窗28有一些交迭覆盖。这个实施例的窗28的数量为四个且形状为大体圆形。可理解,构想到窗的数量和窗的形状的变化。例如,构想到这样的实施例,其包括1、2、3、4、5、6、7、8、9、10个或更多个窗,并且包括圆形、矩圆形、长方形或多边形的窗。此外,具有不同的长度和宽度的窗可定向成使得最大的尺寸平行于纵向轴线,垂直于纵向轴线或相对于纵向轴线处于另一个角度,诸如45度角度。在一些实施例中,各个窗可具有为2:1、3:1或4:1的纵横比,其中主尺寸垂直于囊的纵向轴线。在一些实施例中,窗可具有定制型式,以提供特定处理型式。
电极24可为扁平的带状电极,其由铂、金、不锈钢、钴合金或其它非氧化材料制成。在一些情况下,可使用钛、钽或钨。电极24可沿着囊22的基本整个长度延伸或可仅延伸到最远侧窗28的远侧边缘。电极24可具有大体螺旋形状且可包绕在轴34周围。在一些情况下,电极24可粘结到轴34上。电极24和窗28可布置成使得电极直接在窗28下面延伸。在一些实施例中,电极24可为线材或可为围绕轴34而设置的管状部件。在一些实施例中,可使用多个电极24,并且多个中的各个可在窗28下面固定到轴34上,并且可共用连接到传导性元件16上的公共件。在包括不止一个电极的其它实施例,可单独地控制各个电极。在这样的实施例中,囊可分成不止一个室,并且各个室可包括一个或多个电极。电极可选择成对囊提供特定柔性水平,以增强系统的可操纵性。可理解的是,对于电极24构想到许多变型。
图6示出另一个肾神经调变装置12的远侧部分,除了这里所描述,该肾神经调变装置12类似于图2的装置12。图6的肾神经调变装置12包括之前描述的元件,诸如轴34、多层囊22和电极24。代替图2的实施例中示出的多个窗28,这个实施例具有单个螺旋窗28。螺旋窗28可包绕在囊22周围达至少一个整圈,或2、3、4、5或更多圈,如示出的那样。一些实施例包括两个或更多个螺旋窗28,它们彼此间隔开且以相同的节距绕在囊22周围。
另一个变型示出在图7中,其中,代替图2的实施例中示出的多个囊28,这个实施例具有单个囊28,其沿周向围绕囊22的中间部分延伸。在这个实施例的其它构想到的变型中可包括两个、三个或更多个相同窗28。在一个构想到的变型中,整个囊壁对于RF能量是可穿透。这种实施例可具有包括层44而不具有层46的囊。
图8示出另一个肾神经调变装置12的远侧部分,除了本文所描述,该肾神经调变装置12类似于图2的装置12。图7的肾神经调变装置12包括之前描述的元件,诸如轴34、多层囊22和电极24(未示出)。这个实施例的囊22为螺旋形且包绕在轴34周围。窗28为螺旋形且遵从螺旋的外直径。这个实施例的变型示出在图9中,其中,窗28周期性地沿着螺旋囊22的外直径设置。窗优选布置成提供完全周向覆盖,同时沿纵向间隔开。可如期望的那样改变窗28的数量和形状。
图10a和10b示出另一个肾神经调变装置12的远侧部分,除了本文所描述,该肾神经调变装置12类似于图2的装置12。图10a示出在标称压力下扩张的装置12,并且图10b示出在较高压力下扩张的装置12。较高压力允许窗28扩张超过囊的第二层46的外表面。以这个方式,图10a和10b的装置12的特定尺寸可适于更宽范围的尺寸的血管。可以各种方式制成装置12。参照图4可理解,窗28可比囊22的其它部分更薄。较薄的柔性聚合物(诸如亲水性聚氨酯)层可比囊的其余部分中存在的双层材料更容易扩张。可通过对囊22的第二层46使用柔性较低的材料或通过增加第二层46的厚度来增强这个作用。适当的材料可包括柔性较低的聚氨酯(不同的硬度85A至55D)、尼龙或聚对苯二甲酸乙二醇酯(PET)或任何适当的不导电聚合物。
在图10b的实施例的变型中,囊可模制或热处理成使得窗28成形为在标称压力下为凹形,如这个图中示出。在这种实施例中,窗可在较低的压力下接触血管壁,并且通过应用不同的量的压力,囊将可扩张到不同的直径。
图11a-11d示出囊壁的圆柱形中心部分的透视图(即图示出被切开和摊平的囊壁的圆柱形中心部分,)。这些图的囊壁可容易地结合到本文描述的任何神经调变系统中。囊22包括由于缺乏电绝缘层44而限定的多个窗28。窗布置在囊上,使得它们的最大尺寸沿周向(即沿着圆柱形囊壁的周边)延伸,而它们的最窄尺寸沿轴向(即沿囊22的中心纵向轴线的方向)延伸。窗28布置成使得从圆柱形囊壁的近侧端到圆柱形囊壁的远侧端画出的任何线穿过至少一个囊。
窗可沿周向交迭,同时沿轴向间隔开。如果从圆柱形囊壁的近侧端到圆柱形囊壁的远侧端画出的线穿过两个囊,那两个囊称为沿周向交迭。
周向交迭的程度可根据窗28的周向尺寸、根据囊的周长或根据绝对尺寸表示。例如,两个相邻的窗展示的周向交迭可例如介于0.2和0.8mm之间、介于0.3和0.7mm之间、介于0.4和0.6mm之间、为至少0.3mm、为至少0.4mm或为至少0.5mm,或为两个窗中的一个的周向尺寸的20%至30%、为两个窗中的一个的周向尺寸的24%至26%、为圆柱形囊壁的周向尺寸的5%至15%、为圆柱形囊壁的周向尺寸的6%至7%,或为圆柱形囊壁的周向尺寸的10%至14%。
窗28优选具有比轴向尺寸更大的周向尺寸。例如,窗的轴向尺寸与周向尺寸的比率可大于1.5:1、大于2:1、大于3:1或为一些其它适当的数字。窗具有的轴向尺寸可为1mm、1.25mm、1.5mm、1.75mm、2mm、2.25mm、2.5mm或其它适当的尺寸,并且周向尺寸大于3mm,诸如为3mm、3.5mm、4mm、4.5mm或5mm。窗28的周向尺寸可为圆柱形部分囊壁的周长的20%、25%、30%或其它适当的百分比。
图11a和11b的窗28显示为以大体螺旋方式布置,其中各个相邻的窗沿轴向和沿周向(同时沿周向交迭)相对于之前的窗偏移。可使用足以提供完全的周向覆盖范围的任何数量的窗。在图11a的实施例中,示出了五个窗28。一些实施例可包括3、4、5、6、7、8、9、10个或更多个窗,并且如果如图6中示出的那样螺旋地布置,窗可围绕囊壁延伸不止一圈。将理解,螺旋构造对于提供完全的周向覆盖不是必须的。完全周向覆盖表示窗布置成使得从圆柱形囊壁的近侧端到圆柱形囊壁的远侧端画出的任何线穿过至少一个囊。
图11a的窗示出为椭圆形。图11b-11d示出其它适当的窗形状,诸如矩圆形(图11b)、蝶形领结形(图11c)和钻石(图11d)。
图11c和11d示出其中不止一个窗28沿着同一周边定位成使得窗处于网格型式的囊型式。可想到使窗位于假想网格的各个相交部上,其中网格的线为在圆柱形囊壁上的周向线和从圆柱形囊壁的近侧端延伸到远侧端的螺旋线。网格线可以规则间距或以不规则间距间隔开。网格可包括两根周向线和两根螺旋线,并且因而提供窗所处的四个相交部。网格可包括三根周向线和两根螺旋线,并且因而提供窗所处的六个相交部。网格可包括四根周向线和两根螺旋线,并且因而提供窗所处的八个相交部。网格可包括五根周向线和两根螺旋线,并且因而提供窗所处的十个相交部(如图11c和11d中示出)。网格可包括两根周向线和三根螺旋线,并且因而提供窗所处的六个相交部。网格可包括三根周向线和三根螺旋线,并且因而提供窗所处的九个相交部。网格可包括四根周向线和三根螺旋线,并且因而提供窗所处的十二个相交部。或者网格可包括呈任何规则或不规则型式的任何期望的数量的周向线和螺旋线,只要窗提供完全周向覆盖。可理解的是,通过这种网格型式的窗产生显著周向交迭。因为在窗对应于血管壁上的提供消融处理的位点,所以这种周向交迭有助于确保血管壁的完全周向处理。
具有窗28的多层囊22可根据本文描述的一个方法或另一种适当的方法制造。在一个方法中,使用吹塑技术或其它适当的方法分开来制造囊的第一层44和第二层46。通过激光、冲孔、机械或液压切割元件或其它适当的技术使孔形成于第二层46中。第一层44定位在第二层46的内侧,并且使用热、化学溶剂、粘合剂或其它适当的技术使两个层44、46熔融在一起。在一些情况下,两个层可定位在模具的内侧,以及/或者可在层44的内侧施加压力,以使用热、溶剂或粘合剂来熔融处于扩张位置的两个层。在一些情况下,两个层不直接连结,而是单独地附连到轴34上。
在另一种制造方法中,内层44形成于柔性心轴上。柔性心轴具有与处于扩张位置的内层44的形状相同的形状,但是由不会很好地粘附到内层44的材料上的材料制成,诸如硅。可通过浸渍涂覆、喷涂、吹塑或其它适当的技术使内层44形成在柔性心轴上。在期望有一个或多个窗28的位置将掩模材料应用在内层上。可使用可移除或临时粘合剂来将掩模材料固定到内层上。然后使用非传导性聚合物再次对其上具有内层和掩模材料的柔性心轴进行浸渍涂覆,以形成外层46。在掩模材料的边缘处切割外层,并且移除掩模材料以及在掩模材料上的外层材料,因而形成囊22。最终,从囊22内移除柔性心轴。
图8和图9的实施例的螺旋囊可由囊前体形成,囊前体具有并排的两个内腔。第一内腔为囊内腔而第二内腔配合在轴34上。这个囊前体形成具有上面所论述的窗28的双层囊。然后将笔直的心轴插入第二内腔中,并且使囊前体围绕笔直的心轴扭转,以使第一内腔形成为螺旋形状。第二内腔可碰撞,并且扭转的囊前体热定形成螺旋形状。在一些变型中,扭转的囊前体插入螺旋模具中,并且在螺旋模具中进行热定形,以帮助形成螺旋囊形状。然后从第一内腔移除笔直的心轴,并且然后使螺旋囊22连结到轴上。
在使用中,提供了诸如系统12的肾消融系统。系统可与标准引导导管一起使用,诸如6 弗伦奇(French)引导导管。作为预备步骤的一部分,可对囊且具体而言亲水性或亲和性(techophilic)材料进行水合。可通过将囊浸泡在盐溶液中来实现水合。可进行一分钟、五分钟或其它适当的浸泡。然后,通过使用引导导管和/或引导线,可经皮引入系统12,如在血管内医疗装置领域中传统上进行的那样。例如,可经皮通过股骨动脉引入诸如0.014″直径引导线的引导线,并且使用标准的射线照相技术来将其操纵到肾动脉。在一些实施例中,输送鞘14可在引导线上引入,并且可抽出引导线,并且系统12然后可通过输送鞘引入。在其它实施例中,可在引导线上引入系统12,或可在引导线上引入包括输送鞘14的系统。在涉及输送鞘14的实施例中,系统12可从输送鞘14的远侧端向远侧输送就位,或可向近侧抽出输送鞘,以暴露系统12。传导性流体26通过流体入口内腔40和流体入口30引入囊中。传导性流体使囊扩张到期望的尺寸。可通过监测引入到系统中的传导性流体的体积间接地监测囊的扩张,或可通过射线照相或其它传统的手段来监测囊的扩张。可选地,一旦囊扩张成期望的尺寸,就可通过持续通过流体入口30引入流体,同时通过流体出口32从囊抽出流体来使流体在囊内循环。流体的循环数率可在2和20毫升/分钟之间、在3和15毫升/分钟之间、在5和10毫升/分钟之间或为其它期望的循环速率。囊可保持在期望的压力下或附近,诸如在1和6个大气压之间的压力、在1.5和4个大气压之间的压力、在2.5和3.5个大气压之间的压力或处于其它期望的压力。然后通过将能量供应到电极来激活电极24。可在400-500Hz下且在0.5和1安培之间供应能量。能量通过传导性流体的介质且通过窗28传递到血管壁,以对组织进行调变或消融。囊的第二层46阻止能量在窗28(其缺乏第二层46)处以外传送通过囊壁。可借助于通过电极监测阻抗的变化来监测处理的过程。如期望的那样,可在该过程期间进行其它测量,诸如压力和/或温度测量。传导性流体26的循环可缓解血管48的接触窗28的组织的温度的升高。电极24优选激活达有效的时间长度,诸如1分钟或2分钟。一旦过程在特定位置处完成,可部分地或完全地缩小囊22,并且使其移动到不同的位置,诸如其它肾动脉,并且如期望的那样,可使用传统的输送和重新定位技术在另一个位置处重复该过程。
示例
虽然已经参照附图描述神经调变系统的各种实施例,但是现在将使用权利要求的语言来描述若干实施例。但是,以下示例不意图包括本文描述的特征的每个实施例或组合。
1. 一种血管内导管,包括:
伸长部件,其具有近侧端和远侧端;
囊,其具有内表面和外表面、内腔,内腔由内表面限定且包括至少一个RF辐射可穿透的区段,该至少一个区段从囊的内表面延伸到囊的外表面;以及
设置在囊中的电极。
2. 根据示例1的血管内导管,其中,囊进一步包括至少一个不导电的区段。
3. 根据示例1-2中的任一个的血管内导管,其中,囊包括三个或更多个RF辐射可穿透的区段。
4. 根据示例3的血管内导管,其中,三个或更多个区段沿周向和纵向彼此间隔开。
5. 根据示例3至4中的任一个的血管内导管,其中,囊包括四个RF辐射可穿透的区段。
6. 根据示例1的血管内导管,其中,至少一个区段为螺旋形区段。
7. 根据示例1的血管内导管,其中,至少一个区段为围绕囊的周边延伸的圆柱形区段。
8. 根据示例7的血管内导管,其中,至少一个区段在囊上居中地定位在囊的近侧端和囊的远侧端之间。
9. 根据示例1至2中的任一个的血管内导管,其中,囊具有螺旋形内腔。
10. 根据示例9的血管内导管,其中,至少一个区段为螺旋形且沿着囊的外直径延伸。
11. 根据示例9的血管内系统,其中,囊包括三个或更多个RF辐射可穿透的区段。
12. 根据示例11的血管内系统,其中,三个或更多个区段沿周向和纵向彼此间隔开。
13. 根据示例11至12中的任一个的血管内系统,其中,囊包括四个RF辐射可穿透的区段。
14. 根据示例9至13中的任一个的血管内导管,其中,区段位于螺旋的外直径上。
15. 根据示例2至14中的任一个的血管内导管,其中,至少一个RF可穿透区段包含柔性聚合材料。
16. 根据示例15的血管内导管,其中,不导电区段包含非柔性聚合材料。
17. 根据示例1至16中的任一个的血管内导管,其中,至少一个RF可穿透区段包含亲水性聚合物。
18. 根据示例17的血管内导管,其中,至少一个RF可穿透区段包含亲水性聚氨酯。
19. 根据示例1至18中的任一个的导管,其中,至少一个RF可穿透区段包含选自下者组成的组的亲水性聚合物:亲水性皮巴克斯、亲水性尼龙、亲水性聚酯或具有亲水性嵌段的嵌段共聚物、皮巴克斯 MV1074、皮巴克斯 MV 1041、皮巴克斯 MP 1878、皮巴克斯 MV-3000、皮巴克斯 MH-1657。
20. 根据示例17至19中的任一个的导管,其中,至少一个RF可穿透区段包含混合有第二聚合物的亲水性聚合物。
21. 根据示例20的导管,其中,第二聚合物选自下者组成的组:皮巴克斯 6333、皮巴克斯 7033、皮巴克斯 7233、尼龙 12、维斯塔米德 L2101F、格里拉米德 L20和格里拉米德 L25。
22. 根据示例17至21中的任一个的导管,其中,亲水性聚合物具有20%至50%的亲水性。
23. 根据示例2至22中的任一个的导管,其中,不导电区段包含非亲水性聚合物。
24. 根据示例2至23中的任一个的血管内导管,其中,不导电区段包含非亲水性聚氨酯。
25. 根据示例1至24中的任一个的血管内导管,其中,囊包括第一层和第二层。
26. 根据示例25的血管内导管,其中,第一层对于RF辐射是可穿透的,而第二层为不导电的。
27. 根据示例25至26中的任一个的血管内导管,其中,第一层在第二层的内侧。
28. 根据示例25至27中的任一个的血管内导管,其中,至少一个RF辐射可穿透的区段不包括第二层。
29. 根据示例25至28中的任一个的血管内导管,其中,至少一个RF辐射可穿透的区段基本由第一层构成。
30. 根据示例25至29中的任一个的血管内导管,其中,在至少一个RF辐射可穿透的区段处,第一层限定囊的外表面。
31. 根据示例25的血管内导管,其中,第一层对于RF辐射是可穿透的而第二层不导电,其中,第一层大体在第二层的内侧,其中,在至少一个RF辐射可穿透的区段处,第一层限定囊的外表面,并且其中,在至少一个RF辐射可穿透的区段处,第一层沿径向延伸超过第二层。
32. 根据示例31的血管内导管,其中,至少一个RF辐射可穿透的区段包括多个凸形窗。
33. 根据示例1至32中的任一个的血管内导管,其中,电极在至少一个可穿透RF的区段下面延伸。
34. 根据示例1至32中的任一个的血管内导管,其中,电极延伸囊的长度的至少80%。
35. 根据示例1至34中的任一个的血管内导管,其中,电极为螺旋形。
36. 根据示例1至35中的任一个的血管内导管,其中,伸长部件延伸囊的长度。
37. 根据示例36的血管内导管,其中,电极设置在伸长部件的外表面上。
38. 根据示例36至37中的任一个的血管内导管,其中,伸长部件包括具有开口远侧端的引导线内腔。
39. 根据示例36至38中的任一个的血管内导管,其中,伸长部件进一步包括流体供应内腔,其具有流体地连接到囊内腔的开口。
40. 根据示例39的血管内导管,其中,伸长部件进一步包括流体返回内腔,其具有流体地连接到轴的开口。
41. 根据示例40的血管内导管,其中,流体供应内腔的开口在流体返回内腔的开口的远侧。
42. 根据示例41的血管内导管,其中,流体供应内腔的开口在囊的远侧腰部中。
43. 根据示例42的血管内导管,其中,流体返回内腔的开口在囊的近侧腰部中。
44. 根据示例1至43中的任一个的血管内导管,进一步包括温度传感器。
45. 根据示例44的血管内导管,其中,温度传感器设置在伸长部件上。
46. 根据示例44的血管内导管,其中,温度传感器设置在囊上。
47. 一种血管内导管,包括:
伸长部件,其具有近侧端和远侧端;
囊,其具有内腔和囊壁,囊壁包括通过不导电囊壁的一个或多个RF可穿透窗,一个或多个RF可穿透窗不透流体流;
电极,其设置在囊内且向远侧延伸到最远侧的RF可穿透区段。
48. 根据示例47的血管内导管,其中,电极为螺旋形。
49. 根据示例47至48中的任一个的血管内导管,其中,伸长部件延伸通过囊。
50. 根据示例49的血管内导管,进一步包括流体地连接到囊内腔的流体供应内腔和流体返回内腔。
51. 一种血管内导管,包括:
伸长部件,其具有近侧端和远侧端;
囊,其具有内表面、外表面、由内表面限定的内腔和在内表面和外表面之间延伸的圆柱形壁,圆柱形壁具有近侧端和远侧端,囊具有多个导电窗,其设置在壁中且能够在内表面和外表面之间传送电流,多个窗布置成使得沿着壁从壁的近侧端到壁的远侧端延伸最短距离的每根线穿过至少一个窗,其中,除了沿轴向方向之外,多个窗中的至少一个进一步沿周向方向延伸,并且其中,囊壁在别处是电绝缘的;以及
设置在囊中的电极。
52. 根据示例51的导管,其中,多个窗中的至少一个为矩圆形。
53. 根据示例51的导管,其中,多个窗中的至少一个为椭圆形。
54. 根据示例51的导管,其中,多个窗中的至少一个为钻石形。
55. 根据示例51的导管,其中,多个窗中的至少一个为蝶形领结形。
56. 根据示例51至55中的任一个的导管,其中,多个窗沿轴向彼此间隔开。
57. 根据示例51至56中的任一个的导管,其中,多个窗以螺旋形状布置在囊壁上。
58. 根据示例51至57中的任一个的导管,其中,任何两个相邻的窗沿周向交迭,使得沿着壁从壁的近侧端到壁的远侧端延伸最短距离的线穿过两个相邻的窗。
59. 根据示例58的导管,其中,任何两个相邻的窗具有至少0.3mm的周向交迭。
60. 根据示例58的导管,其中,任何两个相邻的窗具有至少0.4mm的周向交迭。
61. 根据示例58的导管,其中,任何两个相邻的窗具有至少0.5mm的周向交迭。
62. 根据示例58至61中的任一个的导管,其中,任何两个相邻的窗具有两个相邻的窗中的一个的周向尺寸的20%至30%的周向交迭。
63. 根据示例58至62中的任一个的导管,其中,任何两个相邻的窗具有两个相邻的窗中的一个的周向尺寸的24%至26%的周向交迭。
64. 根据示例58至63中的任一个的导管,其中,任何两个相邻的窗具有圆柱形囊壁的周向尺寸的6%至7%的周向交迭。
65. 根据示例58至63中的任一个的导管,其中,任何两个相邻的窗具有圆柱形囊壁的周向尺寸的10%至14%的周向交迭。
66. 根据示例51至65中的任一个的导管,其中,多个窗中的至少一个的周向尺寸与轴向尺寸的比率介于1.5:1和4:1之间。
67. 根据示例51至65中的任一个的导管,其中,多个窗中的至少一个的周向尺寸与轴向尺寸的比率为1.5:1。
68. 根据示例1至65中的任一个的导管,其中,多个窗中的至少一个的周向尺寸与轴向尺寸的比率为大约2:1和4:1。
69. 根据示例1至65中的任一个的导管,其中,多个窗中的至少一个的周向尺寸与轴向尺寸的比率为大约3:1。
70. 根据示例1至69中的任一个的导管,其中,多个窗中的各个的周向尺寸与轴向尺寸的比率相同。
71. 根据示例1至70中的任一个的导管,其中,多个窗中的各个为相同形状。
72. 根据示例1至71中的任一个的导管,其中,多个窗包括四个窗。
73. 根据示例1至72中的任一个的导管,其中,多个窗包括六个窗。
74. 根据示例1至73中的任一个的导管,其中,多个窗包括八个窗。
75. 根据示例1至74中的任一个的导管,其中,多个囊布置在网格的相交部上,其中,网格线为囊壁的多根周向线,并且多根螺旋线从囊壁的近侧端延伸到囊壁的远侧端。
76. 根据示例75的导管,其中,多根螺旋线围绕囊壁均等地间隔开。
77. 根据示例75至76中的任一个的导管,其中,多根螺旋线由两根螺旋线构成。
78. 根据示例75至76中的任一个的导管,其中,多根螺旋线由三根螺旋线构成。
79. 根据示例75至76中的任一个的导管,其中,多根螺旋线由四根螺旋线构成。
80. 根据示例75至79中的任一个的导管,其中,多根周向线以规则的间距间隔开。
81. 根据示例75至80中的任一个的导管,其中,多根周向线由两根周向线构成。
82. 根据示例75至80中的任一个的导管,其中,多根周向线由三根周向线构成。
83. 根据示例75至80中的任一个的导管,其中,多根周向线由四根周向线构成。
84. 根据示例51至83中的任一个的导管,其中,多个囊中的至少一个的周向尺寸为圆柱形囊壁的周长的20%至30%。
85. 根据示例51至84中的任一个的导管,其中,多个囊中的至少一个的周向尺寸为圆柱形囊壁的周长的22%至28%。
86. 根据示例51至85中的任一个的导管,其中,多个囊中的至少一个的周向尺寸为圆柱形囊壁的周长的24%至26%。
87. 根据示例51至86中的任一个的导管,其中,多个窗包含亲水性聚合物。
88. 根据示例51至87中的任一个的导管,其中,多个窗包括选自下者组成的组的亲水性聚合物:亲水性皮巴克斯、亲水性尼龙、亲水性聚酯,或具有亲水性嵌段的嵌段共聚物、皮巴克斯 MV1074、皮巴克斯 MV 1041、皮巴克斯 MP 1878、皮巴克斯 MV-3000、皮巴克斯 MH-1657。
89. 根据示例87至88中的任一个的导管,其中,多个窗包含与第二聚合物混合的亲水性聚合物。
90. 根据示例89的导管,其中,第二聚合物选自下者组成的组:皮巴克斯 6333、皮巴克斯 7033、皮巴克斯 7233、尼龙 12、维斯塔米德 L2101F、格里拉米德 L20和格里拉米德 L25。
91. 根据示例87至90中的任一个的导管,其中,亲水性聚合物具有20%至50%的亲水性。
92. 根据示例51至91中的任一个的导管,其中,囊壁包含非亲水性聚合物。
93. 根据示例51至92中的任一个的导管,其中,囊包括第一层和第二层。
94. 根据示例70的血管内导管,其中,第一层为导电的而第二层为不导电的。
95. 根据示例93至94中的任一个的血管内导管,其中,第一层在第二层的内侧。
96. 根据示例93至95中的任一个的血管内导管,其中,多个窗不包括第二层。
97. 根据示例93至96中的任一个的血管内导管,其中,多个窗基本由第一层构成。
98. 根据示例51至97中的任一个的血管内导管,其中,电极延伸囊的长度的至少50%。
99. 根据示例51至97中的任一个的血管内导管,其中,电极延伸囊的长度的至少80%。
100. 根据示例51至99中的任一个的血管内导管,其中,电极延伸囊的长度。
101. 根据示例51至99中的任一个的血管内导管,其中,电极为螺旋形。
102. 根据示例51至101中的任一个的血管内导管,其中,伸长部件延伸囊的长度。
103. 根据示例102的血管内导管,其中,电极设置在伸长部件的外表面上。
104. 根据示例102至103中的任一个的血管内导管,其中,伸长部件包括具有开口远侧端的引导线内腔。
105. 根据示例102至104中的任一个的血管内导管,其中,伸长部件进一步包括流体供应内腔,其具有流体地连接到囊内腔的开口。
106. 根据示例105的血管内导管,其中,伸长部件进一步包括流体返回内腔,其具有流体地连接到轴的开口。
107. 根据示例106的血管内导管,其中,流体供应内腔的开口在流体返回内腔的开口的远侧。
108. 根据示例107的血管内导管,其中,流体供应内腔的开口在囊的远侧腰部中。
109. 根据示例108的血管内导管,其中,流体返回内腔的开口在囊的近侧腰部中。
110. 根据示例51至109中的任一个的血管内导管,进一步包括温度传感器。
111. 根据示例110的血管内导管,其中,温度传感器设置在伸长部件上。
112. 根据示例110的血管内导管,其中,温度传感器设置在囊上。
113. 一种对神经进行调变的方法,包括:
提供根据示例1至112中的任一个的导管;
使囊移动到关注区域;
利用导电流体使囊膨胀;以及
激活电极。
114. 根据示例113的方法,其中,使囊移动到关注区域的步骤包括使导管在血管内前进的步骤。
115. 根据示例113至114中的任一个的方法,其中,使囊移动到关注区域的步骤包括使导管沿着引导线前进的步骤。
116. 根据示例113至115中的任一个的方法,其中,使囊膨胀的步骤包括使囊的外部壁接触关注区域的步骤。
117. 根据示例116的方法,进一步包括使流体以5毫升/分钟至10毫升/分钟的速率循环通过囊的步骤。
118. 根据示例114至117中的任一个的方法,其中,导电流体包括盐水。
119. 根据示例114至118中的任一个的方法,其中,导电流体包括高渗溶液。
120. 根据示例114至119中的任一个的方法,其中,导电流体包括对比溶液。
121. 根据示例113至120中的任一个的方法,进一步包括在使囊移动到关注区域之前使囊进行水合的步骤。
122. 根据示例121的方法,其中,使囊进行水合的步骤包括在盐溶液中浸泡囊的步骤。
123. 根据示例72的方法,其中,在盐溶液中浸泡囊的步骤包括在盐溶液中浸泡囊达至少一分钟。
124. 根据示例72的方法,其中,在盐溶液中浸泡囊的步骤包括在盐溶液中浸泡囊达至少五分钟。
在不脱离本发明的范围和原理的情况下,本发明的各种修改和变化对于本领域技术人员将变得显而易见,并且应当理解,本发明不应当不适当地限于本文在上面阐述的说明性实施例。所有出版物和专利通过引用而结合在本文中,达各个单独的出版物或专利特别和单独地被指示要通过引用而结合的程度。
Claims (15)
1. 一种血管内导管,包括:
伸长部件,其具有近侧端和远侧端;
囊,其具有内表面和外表面、内腔,所述内腔由所述内表面限定且包括三个或更多个RF辐射可穿透的、从所述囊的内表面延伸到所述囊的外表面的区段,以及至少一个不导电区段;以及
设置在所述囊中的电极。
2. 根据权利要求1所述的血管内导管,其特征在于,所述三个或更多个RF辐射可穿透的区段沿周向和纵向彼此间隔开。
3. 根据权利要求1或2中的任一项所述的血管内导管,其特征在于,所述三个或更多个RF辐射可穿透的区段各自包含亲水性聚合物。
4. 根据权利要求3所述的血管内导管,其特征在于,所述亲水性聚合物为亲水性聚氨酯。
5. 根据权利要求1至4中的任一项所述的导管,其特征在于,所述三个或更多个RF辐射可穿透的区段各种包含混合有第二聚合物的亲水性聚合物。
6. 根据权利要求5所述的导管,其特征在于,所述第二聚合物选自下者组成的组:皮巴克斯 6333、皮巴克斯 7033、皮巴克斯 7233、尼龙 12、维斯塔米德 L2101F、格里拉米德 L20和格里拉米德 L25。
7. 根据权利要求3至6中的任一项所述的导管,其特征在于,所述亲水性聚合物具有20%至50%的亲水性。
8. 根据权利要求1至7中的任一项所述的导管,其特征在于,所述不导电区段包含非亲水性聚合物。
9. 根据权利要求1所述的血管内导管,其特征在于,所述囊包括第一层和第二层,其中,所述第一层对于RF辐射是可穿透的而所述第二层为不导电的,并且可选地其中,所述第一层在所述第二层的内侧。
10. 根据权利要求9所述的血管内导管,其特征在于,所述三个或更多个RF辐射可穿透的区段不包括所述第二层,而是可选地基本由所述第一层构成。
11. 根据权利要求1至10中的任一项所述的血管内导管,其特征在于,所述电极在三个或更多个RF可穿透的区段下面延伸。
12. 根据权利要求1至11中的任一项所述的血管内导管,其特征在于,所述电极为螺旋形。
13. 根据权利要求1至12中的任一项所述的血管内导管,其特征在于,所述伸长部件包括具有开口远侧端的引导线内腔。
14. 根据权利要求1至13中的任一项所述的血管内导管,其特征在于,所述伸长部件进一步包括:流体供应内腔,其具有流体地连接到所述囊内腔的开口;以及流体返回内腔,其具有流体地连接到所述轴的开口。
15. 根据权利要求14所述的血管内导管,其特征在于,所述流体供应内腔的开口在所述三个或更多个RF辐射可穿透的区段的远侧。
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CN104135958B (zh) | 2017-05-03 |
WO2013101452A1 (en) | 2013-07-04 |
US9757177B2 (en) | 2017-09-12 |
US20160331432A1 (en) | 2016-11-17 |
EP2797534A1 (en) | 2014-11-05 |
US20130172872A1 (en) | 2013-07-04 |
US9433760B2 (en) | 2016-09-06 |
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