CN1867299B - 动脉粥样硬化物的可选择偏心重塑和/或消融 - Google Patents

动脉粥样硬化物的可选择偏心重塑和/或消融 Download PDF

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CN1867299B
CN1867299B CN2004800301639A CN200480030163A CN1867299B CN 1867299 B CN1867299 B CN 1867299B CN 2004800301639 A CN2004800301639 A CN 2004800301639A CN 200480030163 A CN200480030163 A CN 200480030163A CN 1867299 B CN1867299 B CN 1867299B
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T·A·斯坦克
C·W·斯通
S·O·罗斯
B·S·凯莱赫
R·M·米歇尔
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Abstract

一种用于偏心重塑和/或清除患者血管内动脉粥样硬化物的导管和导管系统，包括具有径向可扩张结构的细长柔性导管体。当该结构扩张时，多个电极或其它电外科能量传递面能够径向接合动脉粥样硬化物。位于导管体远端附近的动脉粥样硬化物检测器可以测量环状动脉粥样硬化物的分布，并且能量源可以有选择地为电极供能，从而偏心重塑测量到的动脉粥样硬化物。

Description

动脉粥样硬化物的可选择偏心重塑和/或消融
本发明是正规的非临时专利申请，其根据USC 119(e)第35条要求了2003年9月12日申请的美国临时申请No.60/502,515的优先权，该申请的全部内容包括在这里作为参考。
技术领域
本发明通常涉及医疗装置、系统和方法。在典型实施方案中，本发明提供一种基于导管的对动脉内堆积的动脉粥样硬化斑块进行重塑和/或清除的方法，用以改善血流，并且这种重塑和/或清除通常不使用球囊血管形成术、支架置入术和/或扩张术。本发明的结构允许图像引导的偏心动脉粥样硬化物的重塑和/或清除，并且理论上允许使用具有协同定位的血管内成像能力，其中上述重塑和/或清除经常在血管内部的受控环境带使用电外科能量，可选地使用电外科消融术。相关实施方案可以应用在各种体腔中，包括泌尿、生殖、胃肠和肺梗阻物质的清除，也可以用于清除或缩小肿瘤、囊肿、息肉和类似物。
背景技术
临床医生可以使用导管获得通向身体内部组织的通道并修复体内组织，尤其是对于那些位于体腔内部(诸如血管)的体内组织。例如，球囊血管形成术和其它导管通常被用于开通那些由于动脉粥样硬化疾病已经变窄的动脉。
球囊血管形成术在开通闭塞血管上通常是有效的，但是和球囊扩张术相关的损伤能够造成明显的伤害，这样球囊扩张术的益处可能会在时间上受到限制。支架通常是用于扩大血管的有用开口。
结合球囊扩张术的支架置入术通常是动脉粥样硬化的优选疗法。在支架置入术中，折叠金属框架被安装在插入体内的球囊导管上。支架被操控进入到闭塞部位，并且通过隐伏(underlying)球囊的扩张，支架在适当位置被扩张。支架置入术已经得到了广泛的认同，并且在许多情况下产生令人满意的结果。除血管(尤其是冠状动脉)治疗以外，支架还可以用于治疗体内的许多其它管状梗阻，诸如用于治疗生殖、肠胃和肺梗阻。
支架置入术后的体腔再狭窄或继发狭窄已经在大量案例中出现。最近，药物涂层支架(诸如Johnson&Johnson的CypherTM支架，包括SirolimusTM的相关药物)已经显现出了明显减少的再狭窄率，并且其它公司也正在开发和销售可选择的药物涂层支架。此外，使用全身药物输送(静脉内或口服)的工作也已经被启动，这种全身药物输送有可能改善常规血管形成术的成功率。
尽管药物涂层支架看起来像是为许多患者的动脉粥样硬化治疗提供了可靠的保证，但是仍然存在许多不能使用支架或支架表现出明显缺点的情况。通常，支架置入术在体内留下了植入物。这种植入物可能表现出包括机械疲劳、腐蚀和类似情况在内的风险，尤其是当植入物难以去除、需要进行有创外科手术时会存在风险。在治疗弥漫性动脉疾病、治疗分叉、治疗易碎身体区域和治疗经受扭曲、拉伸以及缩短的动脉时，支架置入术可能存在其它的缺点。
通常和球囊血管形成术和/或支架置入术一起使用的各种经过修改的再狭窄治疗或抑制闭塞的再狭窄治疗方式也已经被提出，它们包括血管内放射疗法、低温治疗、超声波能量和其它类似方法。尽管这些治疗方式和其它不同的实现方式可以在不同程度上保证在血管形成术和支架置入术后的血流中减少继发降解，但是最初由血管形成术施加在组织上损伤仍然难以解决。
许多替代支架置入术和球囊血管形成术用于开通已狭窄动脉的方法也已经被提出。例如，各种斑块清除术装置和技术已经被公开并被尝试。尽管球囊血管形成术和支架置入术存在缺点和局限性，但是斑块清除术没有得到广泛使用，而且也没有获得基于扩张术的方法的成功率。扩张术的其它缺点已经为人所知。这些缺点包括存在易损斑块，上述易损斑决能够破裂并且释放可以导致心肌梗死或心脏病的物质。
鉴于上述原因，因此应当提出新装置、新系统和新方法用于动脉粥样硬化物和其它体腔闭塞(尤其是血管闭塞)的重塑和/或清除。此外，应当在没有造成扩张损伤的情况下清除这些闭塞物，并允许开通不适合支架置入的血管和其它体腔。
发明内容
在第一个方面，本发明提供一种导管系统，用于患者血管动脉粥样硬化物的偏心重塑。该系统包括一个细长柔软的导管体，该导管体具有远端和近端以及位于远近端之间的轴线。径向可扩张结构被设置在导管体末端附近，当可扩张结构扩张时，多个能量传递面均沿径向定向，从而提供绕血管轴线沿圆周分布的能量传递面阵列。动脉粥样硬化物检测器被设置用于沿着血管的圆周动脉粥样硬化物的检测。能量源被电连接到能量传递面上。将所述能量源连接到所述阵列的控制器，用于响应检测到的动脉粥样硬化物有选择地为能量传递面的偏心子集提供能量，能量源向能量传递面提供能量，以便通过对血管进行温和加热而将血管外层的温度限制到不超过63℃，来沿着血管偏心地重塑检测到的动脉粥样硬化物。
本发明还提供了一种对患者血管中动脉粥样硬化物进行偏心重塑的系统，该系统包括：具有近端和远端以及位于其间的轴线的细长体；位于导管体远端附近的径向可扩张结构；当可扩张结构在所述血管内扩张时定向成沿着血管在径向对抗所述动脉粥样硬化物的多个电极，从而限定出轴对称的电极阵列；与所述细长体相连的用于对所述动脉粥样硬化物进行圆周测量的动脉粥样硬化物检测器；和与电极电连接的能量源，该能量源有选择地为电极的偏心子集供电，以便通过温和加热到在50℃到60℃范围内的温度来偏心重塑所测量到的动脉粥样硬化物。
能量源经常有选择地对一部分能量传递面提供能量，以便实现偏心重塑。导管体可以具有在远近端之间延伸的管腔，并且抽吸连接器可以在导管体的近端和管腔流体连通。近端和远端阻隔件可以分别设置在能量传递面的近端和远端，并且抽吸端口可以被设置在近端和远端阻隔件之间，用于在动脉粥样硬化物重塑期间清除碎片。
动脉粥样硬化物检测器可以包括设置在导管体管腔中的血管内超声导管、设置在管腔中的血管内光学相干断层成像导管、设置在管腔中的带有MRI天线的血管内导管或其它类似导管。可选择的检测器可以使用各种无创成像方式中的任何一种，包括使用X线的外部系统、CT系统、无创MRI或NMR系统或类似系统，这样检测器就可以不用设置在血管中。在一些实施方案中，近距治疗导管或其它再狭窄抑制器可以在管腔内被向远端推进。
径向扩张体可以包括多个柔性支撑件，并且能量传递面可以限定一个环状定向阵列，其中上述能量传递面通常包括电极或微波天线。径向可扩张结构的支撑件可以具有位于其间的穿孔，以便限定一个可扩张篮。篮可以具有其间设置有中间部分的近端和远端部分。电极阵列可以沿着中间部分受到支撑，以便当篮在血管内被扩张时能够接合相邻的动脉粥样硬化物。电极可以包括被安装到独立成形篮状支撑件上的电极结构的导电面。在其它实施方案中，电极表面可以作为可扩张结构的一部分被成形加工。例如，电极可以包括通常位于支撑件中点附近的相关支撑件的局部加宽。可扩张结构可以包括NitinolTM，并且Nitinol支撑件的其余表面可以被绝缘。例如，表面可以用高温聚合物(诸如聚酰亚胺或类似物)覆盖。作为另一种选择，也可使用包括聚氨酯在内的其它涂层。这些支撑件可以彼此电气绝缘，这样每一个支撑件均能够用于将能量从支撑件近端延伸出来的导体中传递到和支撑件相关的电极表面上，以便将每一个电极表面独立连接到控制器上。
远端膜可以在电极远端的血管内展开，以便抑制碎片的远端运动。近端膜可以在电极近端展开，以便抑制碎片的近端运动。例如，在动脉粥样硬化物的消融期间，膜可以阻止血液和重塑过程的相互作用。在其它实施方案中，提供给能量传递面的能量可以被限制，以便抑制碎片的产生，例如，通过改变动脉粥样硬化物的性质，通过融化动脉层内部的动脉粥样硬化物，(在治疗期间和/或在组织愈合反应中)通过收缩动脉层内部的动脉粥样硬化物和通过类似方式。在一些实施方案中，远端膜可以由篮的远端部分支撑，以便随其径向扩张。近端膜可以由篮的近端部分支撑，以便随其径向扩张。近端和远端膜中至少有一个包括轴向偏离所述篮的管腔。
尽管一些实施方案可以只具有一个单极电极、或两个或更多个单极或双极电极，但是电极可以包括一个电极阵列，该阵列通常包括6个或更多个电极，至少有3个可供选择的可选择电极围绕轴线圆周分布。控制器可以将能量源连接到电极阵列上，以便根据检测到的动脉粥样硬化物有选择地为电极阵列的偏心子集提供能量。控制器通过将RF能量和/或微波能量指向该处，可以有选择地为能量定向面的子集提供能量。动脉粥样硬化检测器可以包括超声换能器或光学相干反射器(reflectrometer)。这些检测器除了可以具有能够插入到导管管腔中的独立结构以外，还可以被整合到导管结构中。显示装置可以被连接到动脉粥样硬化物检测器上，用于显示围绕导管轴线分布的圆周状的动脉粥样硬化物厚度的图像。
在另一个方面中，本发明提供一种导管系统，用于从患者血管中偏心重塑和/或清除动脉粥样硬化物。上述系统能够包括一个细长柔软的导管体，该导管体具有远端和近端以及位于远近端之间的轴线。径向可扩张结构被设置在导管体的近端附近。当可扩张结构扩张时，多个电极用于和动脉粥样硬化物径向接合。动脉粥样硬化物检测器或成像传感器被设置在导管体的近端附近，用于动脉粥样硬化物的圆周识别和测量。能量源为电极提供能量，以便电学清除和/或消融测量到的动脉粥样硬化物。
导管体通常具有在近端和远端之间延伸的管腔。例如，通过使用在导管体的近端和管腔流体连通的抽吸源，管腔可以用作抽吸管腔。近端和远端消融碎片阻隔件可以分别设置在电极的近端和远端，并且设置在近端和远端阻隔件之间的抽吸端口可以在动脉粥样硬化物消融期间清除消融碎片。动脉粥样硬化物检测器可以包括血管内超声导管的超声换能器，其中血管内超声导管被设置在管腔中。作为另一种选择，包括血管内光学相干断层成像在内的其它成像方式也可以被使用。在一些实施方案中，针对圆周动脉粥样硬化厚度经常被测量的情况，成像或动脉粥样硬化物检测能力也可以被整合到导管体中。冲洗管腔可以在导管体近端和导管体远端之间延伸，这样有助于在电极附近获得增强的局部消融环境。再狭窄抑制器可以在管腔内被推进，再狭窄抑制器可选地包括血管内辐射导管、再狭窄抑制药物或类似物。
径向扩张体可以包括多个柔性部件或支撑件，并且电极可选地限定一个环状电极阵列。支撑件可以具有位于其间的穿孔或开口，以便限定一个可扩张篮。电极阵列沿篮的中间部分受到支撑，并且被径向定向，以便当篮在血管内被扩张时能够接合相邻的动脉粥样硬化物。和篮内部流体连通的抽吸端口可以帮助清除任何消融碎片和组织汽化气体，并且抽吸端口可以阻止这些消融副产物在血管内的释放，在篮中流动的流体可以用作冷却流用于限制继发组织损伤。能够在电极远端的血管内展开的远端膜或阻隔件可以阻止任何消融碎片的远端运动，同时能够在电极近端展开的近端膜或阻隔件可以阻止任何消融碎片的近端运动。上述部件也可以减少或阻止位于局部重塑和/或消融环境内的血流。远端膜可以由篮的远端部分支撑以便随其沿径向扩张，和/或近端膜可以由篮的近端部分支撑以便随其沿径向扩张。例如，合适的膜包括一个或多个在血管内轴向偏离篮的球囊，或经过编织的超弹性材料，诸如浸入硅酮的NitinolTM、聚氨酯、PTFE或其它弹性材料。在一些实施方案中，膜至少可以和篮部分整合。
电极通常包括一个电极阵列，该阵列至少有3个、通常包括至少6个围绕导管体的轴线圆周分布的可供选择的可选择电极。电极阵列可以是轴对称的，通过有选择地对阵列中的电极进行配对，可以在没有物理旋转阵列的情况下选择偏心治疗方向。控制器将能量源连接到电极阵列上，用于根据测量到的动脉粥样硬化物有选择地为电极阵列的偏心子集提供能量。典型电极可以包括焊接到铜导线上的不锈钢，其中铜导线和相关可扩张篮元件的支撑元件绝缘。可选择电极可以包括铂(它也允许电极用作射线不透标记)。例如，电极/篮组件可以用高温聚合物覆盖，诸如聚酰亚胺。典型电极阵列包括交替轴向偏移电极，而且控制器通常在电极的供能子集对之间指引RF双极能量，上述子集对可选地包括圆周偏移电极、相邻轴向对齐电极、或在轴向和圆周偏移之间交替的电极。在一些实施方案中，单极能量可以被指向被选电极，其中电回路通过患者地完成。更一般而言，每一个电极通常包括一个通过聚合物固定到可扩张结构相邻支撑件上的金属体，并且包括一个从电极近端伸出的相关导体，以便将电极表面电连接到控制器上。
典型的动脉粥样硬化物检测器包括血管内超声导管的超声换能器、血管内光学相干断层成像导管的传感器或类似传感器。显示装置可以被提供用于显示围绕导管轴线的圆周硬化物厚度的图像，显示和/或成像导管信号可选地包括用于将被选电极和测量旋转配准的方向标记。合适的标记可以包括至少一个扩张部件或标记的“关键部位(key)”或可辨识图像。
在另一个方面中，本发明提供一种用于从患者血管中清除动脉粥样硬化物的导管。该导管包括一个细长柔软的导管体，该导管体具有近端和远端以及位于远近端之间的轴向抽吸管腔。位于导管体远端附近的径向扩张篮具有近端部分和远端部分以及设置在其间的中间部分。环状电极阵列围绕径向扩张篮的中间部分分布，以便当篮在血管内扩张时消融相邻的动脉粥样硬化物。抽吸端口提供位于抽吸管腔和篮内部之间的流体连通。当篮在血管内被扩张时，由篮的远端部分支撑的远端膜可以阻止消融碎片的远端运动。当篮在血管内被扩张时，由篮的近端部分支撑的近端膜可以阻止消融碎片的近端运动。
在根据第一个方法的方面中，本发明提供一种用于重塑患者血管内偏心动脉粥样硬化物的方法。该方法包括确定在血管内与动脉粥样硬化物相邻的导管工作端的位置，导管限定了轴线。导管被径向扩张，以便使导管的至少一个能量传递面和动脉粥样硬化物接合。动脉粥样硬化物围绕导管轴线的圆周分布被确定。根据已确定的动脉粥样硬化物分布，电外科能量相对于导管轴线从至少一个能量传递面被偏心指引。
动脉粥样硬化物的重塑可以包括消融、清除、收缩、融化、变性和/或动脉粥样硬化物的类似变化。例如，功率相对较低的RF能量可以被用于加热动脉粥样硬化物直至其融化，上述物质可选地沿动脉壁、脉管层内部或类似位置被重新分布。可选地，动脉粥样硬化物可以包括易损斑块。易损斑块(和/或易损斑块所涉及的血管)可以使用RF能量治疗，以便将易损斑块帽和易损斑块下面的高脂池温和(mildly)加热到属于大约50到大约60℃范围内的一个温度。这可以被执行，以便产生通常由加热的免疫反应形成的帽增厚。上述增厚有可能导致再狭窄，通过RF能量的准确控制、抗再狭窄药物(诸如RapamycinTM或类似药物)的使用，帽增厚和/或再狭窄可以被限制。除了稳定易损斑块外，本发明还可以用于消除易损斑块，例如可选地通过将高脂池加热到至少大约90℃。优选地，血管加热将被执行，以便将血管外膜或外层温度限制到小于大约63℃，以便阻止胶原收缩和脉管塌陷。相反，适度的RF能量可以被应用到动脉粥样硬化物上，以便改变物质性质并导致物质在治疗期间或治疗后的收缩。动脉粥样硬化物的收缩可以导致更大开通的脉管管腔，并改善血流。
当动脉粥样硬化斑块的重塑包括动脉粥样硬化物的消融时，任何已生成的溶栓(thrombolitic)碎片可以被抑制和/或排出。在消融产生非溶栓碎片的地方，或重塑被执行以便阻止碎片产生的地方，则不需要碎片抑制和排出。
由一个或多个能量传递面指引的电外科能量通常包括RF和/或微波电能。动脉粥样硬化物的圆周分布可以使用血管内或无创技术确定。通过为电极的子集提供能量，电外科能量可以在绕导管轴线旋转能量传递面的情况下被偏心指引。可以根据已确定的动脉粥样硬化物分布选择电极的子集。被选电极可以使用动脉粥样硬化物的分布被旋转配准，例如参考具有可辨识图像的扩张篮的一个或多个结构。例如，被任意确定为电极1的电极支撑件可以具有一个射线不透标记或其它可辨识图像特征，并且作为电极2引用的电极支撑件可以具有两个射线不透标记或两个可辨识图像特征。这能够帮助识别全部电极，因为电极1是可辨识的，而且从电极1到电极2的方向指示环状电极计数方向。各种可选择的可辨识特征也可以被使用。在一些实施方案中，配准可以根据电信号被自动执行。
在另一个方面，本发明提供一种用于从患者血管中偏心清除动脉粥样硬化物的方法。该方法包括确定在血管内与动脉粥样硬化物相邻的导管工作端的位置。导管限定了轴线。导管被径向扩张，以便将导管的多个电极和动脉粥样硬化物接合。围绕导管轴线，动脉粥样硬化物的圆周分布被测量。根据测量到的动脉粥样硬化物的分布，RF能量相对于导管轴线从电极中被偏心指引。
附图说明
图1A说明了弥漫性动脉粥样硬化疾病，其中多条血管的实际长度已经限制了有效直径。
图1B说明了血管内的易损斑块。
图1C说明了一些血管的突然弯曲或扭曲。
图1D说明了位于分叉(bifurcation)处的动脉粥样硬化疾病。
图1E说明了和肢体(extremity)动脉粥样硬化疾病有关的病变。
图1F说明了支架断裂或腐蚀。
图1G说明了血管内的夹层。
图1H说明了围绕健康动脉的动脉壁圆周测量。
图1I说明了围绕再狭窄动脉的粥样斑的圆周分布。
图2示意性地说明了根据本发明的动脉粥样硬化物导管系统。
图2A示意性地说明了用于重塑动脉粥样硬化物的导管系统，其中该系统包括图2中的导管。
图3说明了图2所示导管系统的可扩张篮及相关电极阵列。
图4和5说明了和图2所示导管系统一起使用的可选择篮状结构。
图6A和6B说明了在环状阵列(circumferential array)中具有交替轴向偏移电极的典型篮状结构。
图7A和7B说明了和篮一起使用的典型消融碎片阻隔件。
图7C说明了可供选择的篮和碎片阻隔件。
图8说明了具有专用导体的电极，其中上述专用导体被安装到超弹性金属篮的相关元件上。
图9说明了包括聚酰亚胺的篮，聚酰亚胺用于支撑电极的环状阵列。
图10A-10E说明了使用图2所示导管系统重塑和/或清除动脉粥样硬化物的典型方法。
图11-21示意性地说明了在本发明描述的方法中使用的可选择导管和导管系统。
图22-25示意性地说明了在图2所示系统中有选择地为电极提供能量的控制器。
图26和27示意性地说明了在动脉粥样硬化物重塑导管中使用的可选择流体通道。
图28A-28D说明了在图2所示系统中有选择地为电极提供能量的可选择控制器。
图29A-29H说明了使用独立支撑件构成的可选择篮，其中上述独立支撑件除了它的部件以外，还具有用作电极表面的局部增大宽度。
图30A和30B示意性地说明了允许热电偶和其它温度传感器既用于测量温度又用作电极的电路。
图31示意性地说明了在本发明描述的方法中使用的可选择导管结构。
图32A-32D示意性地说明了在本发明描述的方法中使用的可选择篮和导管结构。
图33示意性地说明了使用微波能量重塑动脉粥样硬化物的可选择导管结构。
图34示意性地说明了另一种可选择导管结构，在本发明描述的方法中该导管结构具有向电极延伸的管腔，以便提供定向冲洗流。
图35示意性地说明了在本发明描述的方法中使用的另一种可选择导管篮状结构，该导管篮状结构具有将冲洗流指向微波天线的管腔。
图36是一个横截面示意图，它显示了通过不同电极提供不同功率电平以便电学重塑动脉粥样硬化物的应用。
图37A-37C说明了另一种可选择导管篮状结构，其中上述篮包括用于支撑电极环状阵列并促进血管内成像的聚酰亚胺。
图38A-38E是经过体腔的横截面侧视图，显示了本发明描述的治疗方法和装置的另一个方面。
图38F-38H是横跨体腔和治疗装置的横截面视图，用于显示偏心治疗方法和装置的另一个方面。
图39A和39B说明了凝胶动脉模型中的偏心治疗装置和方法。
图40是典型导管组件的透视图。
具体实施方式
本发明提供了用于重塑部分闭塞的动脉、从而开通动脉管腔并增加血流量的装置、系统和方法。重塑可以包括电外科能量的应用，上述电外科能量通常是以RF和/或微波电势的形式为电极、天线和类似物这样的能量传递面提供能量。这种能量通常会受到控制，以便限制目标和/或附属(collateral)组织的温度，例如，限制易损斑块纤维帽或动脉结构的内膜层加热到最大结构，使温度处于从大约50到大约60℃的范围内；通过限制外层或血管外膜的最大温度使其不超过大约63℃，从而限制易损斑块高脂池的加热使其足以引起脂质池的融化，同时限制其它组织(诸如内膜层或纤维帽)的加热，使温度小于从大约50到大约60℃范围内的一个温度，以便抑制可能导致再狭窄的免疫反应；或是进行类似的温度限制。相对适度的热能足以使动脉粥样硬化物在治疗期间、治疗后立即发生变性和收缩，和/或在治疗后的一个小时以后、一天以后、一星期以后、甚至一个月以后通过组织对治疗的愈合反应使动脉粥样硬化物变性和收缩，以便提供更大的脉管管腔并改善血流。
在一些实施方案中，动脉粥样硬化斑块的重塑可以包括使用更高的能量用于消融和清除体腔内的闭塞物，尤其是用于清除血管中的动脉粥样硬化物以便改善血流。消融碎片可以由上述消融产生，并且消融碎片可以是溶栓的或非溶栓的。在由消融产生溶栓碎片的地方，上述碎片可以被抑制、捕获和/或从治疗部位排除。由消融产生的非溶栓碎片则不能被抑制和/或从脉管中排出。本发明的技术通常提供电外科能力，适于测量粥样斑和/或血管壁的检测或成像，和/或栓子抑制器。因为在50％的时间内且大概在75％(甚至是更高)的情况中动脉粥样硬化相对于血管轴线是偏心的，所以根据环状动脉粥样硬化物的检测或成像，本发明的装置和方法通常尤其适合用于偏心定向治疗。尽管本发明描述的方法和装置允许上述偏心治疗，但是通过在径向对称的模型中围绕导管轴线或类似轴线有选择地指引能量，上述装置也能够用于治疗径向对称的动脉粥样硬化。
因此，动脉粥样硬化物的重塑可以包括动脉粥样硬化斑和其它斑块的消融、清除、收缩、融化和类似处置。可选地，位于动脉各层内部的动脉粥样硬化物可以被变性以改善血流，这样便不会产生碎片。同样，在不产生治疗碎片的情况下，位于动脉层内的动脉粥样硬化物可以被融化，和/或治疗可以包括位于动脉层内的动脉粥样硬化物的收缩。本发明也对易损斑块或易损斑块所涉及血管的治疗特别有利。上述易损斑块可以包括偏心病变，并且本发明可以尤其适合用于识别易损斑块结构的方向(和轴向位置)。本发明也将找到以帽状结构的适度加热(以导致帽的增厚并使斑块不易破裂)和/或易损斑块高脂池的加热(以便重塑、变性、融化、收缩和/或重新分布高脂池)为目标的应用。
尽管本发明可以和支架置入术和/或球囊扩张术一起使用，但是本发明尤其适合用于在不能实行支架置入术和球囊血管成形术的血管中增大血管的开通直径。潜在的应用包括弥漫性疾病的治疗，在弥漫性疾病中动脉粥样硬化沿动脉相当长的一段长度蔓延，而不是被局限在某一个区域中。通过利用与所述易损斑块分开的所选定的偏心和/或轴向的治疗来潜在地识别和避免对所述易损斑块的治疗，并通过在血管管腔内的受控环境带或区域中有意地消融和抽吸易损斑决的帽和高脂池，本发明也可以对易损斑块或易损斑决所涉及的血管的治疗有利。因为支架不需要被推进到许多血管的急弯中或是不需要在许多血管的急弯内被扩张，所以本发明也发现了针对扭曲、急剧弯曲血管的有利用途。另一种有利应用包括沿分叉(在这里侧枝闭塞可能是问题)和在腿、足和臂这样的外周肢体中(在这里破碎和/或支架断裂故障可能是问题)的治疗。
图1A和1B分别说明了弥漫性疾病和易损斑块。图1C说明了血管扭曲。图1D说明了分叉处的动脉粥样硬化物，而图1E则说明了由肢体动脉粥样硬化疾病引起的病变。
图1F说明了可能由腐蚀和/或疲劳导致的支架结构部件断裂。例如，支架可以被设计成具有10年的植入寿命。当支架接受者的群体存活更长时间的话，就越有可能在这些支架中至少有一部分支架的植入时间要大于它们的设计寿命。和腐蚀身体环境中的任何金属一样，材料降解可能会发生。当金属受到腐蚀变得脆弱时，支架可能断裂。当金属支架受到腐蚀时，它们也可能产生排异反应和可能产生刺激相邻身体组织的副产物。例如，上述疤痕组织可能导致动脉最终的再闭塞或再狭窄。
参考图1G到1I，图中说明了动脉夹层(dissection)和再狭窄。动脉包括3层，分别是内皮细胞层、中间层和外膜层。在血管成形术期间，内侧层可能从血管壁上部分剥离或脱落，以致形成了图1G所示的夹层。上述夹层使血流转向，并且可能阻塞血流。从图1H和1I的比较可以看到血管成形术是可能损伤血管组织的具有较大侵入性的手术。由于存在上述损伤，由于置入了支架，和/或在原先动脉粥样硬化疾病的后续发展中，如图1I所示已开通的动脉可能在直径上再狭窄或此后减少。尽管药物涂层支架已经显示出可以减少再狭窄，但是这些新结构在植入若干年后的功效还没有被充分研究，而且上述药物涂层支架在许多血管中不能使用。
通常，本发明提供一种能够被临床医生较快掌握且易于使用的导管。本发明的导管系统可以允许动脉被开通到至少是它们标称或原有动脉直径的85％。在一些实施方案中，动脉可以被开通到大约85％，和/或急性开通可以小于85％。通过使用充足的能量将组织局部加热到大于大约100℃使组织汽化，快速的闭塞物清除可以被实现，或者更为温和的重塑也可以被使用。
在一些实施方案中，所需的开通直径可以通过导管系统在治疗后被立即实现。作为另一种选择，更为温和的消融可以被执行，例如，在治疗完成时所提供的开通直径不超过原有直径的50％，但是在继发治愈过程被完成以后，仍然可以提供等于80％、甚至85％，或是更大的原有血管开通直径，这应当归因于和心律失常的左心室消融、经尿道前列腺清除术(TURP)治疗类似的受损管腔组织吸收。上述实施方案可以将一些闭塞组织至少加热到在大约55℃到大约80℃范围内的一个温度。在一些实施方案中，闭塞组织可以被加热到在大约93到95℃之间的最大温度。在本发明的其它实施方案中，加热可以被控制，以便提供在大约50到60℃之间的组织温度，其中一些实施方案可以从大约63℃的最大组织温度中受益。还有其它治疗可以从大约90℃的治疗温度中受益。有利地，本发明的导管系统和方法可以在没有使用球囊血管成形术的情况下使用，因此不仅避免了夹层，而且有可能限制再狭窄。
图2和2A示意性地说明了典型的导管系统10。重塑和/或消融导管12包括具有近端16和远端18的导管体14。导管体14柔软易弯曲，并限定了导管轴线20，导管体14包括抽吸管腔22和冲洗管腔24(参见图3)。此外，其它导管可以提供导丝、成像系统或下面描述的功能。管腔22可以用于粥样斑的检测和/或成像以及抽吸。
导管12包括和远端18相邻的径向可扩张结构26以及和近端16相邻的壳体28。远端末端30可以包括一个一体式末端阀用于密封抽吸管腔22，并允许导丝、成像和/或再狭窄抑制导管和类似物通过。
近端壳体28包括和抽吸管腔22流体连通的第一连接器32。抽吸管腔22可以具有位于可扩张结构26内部的抽吸端口，以便允许抽吸或从可扩张结构内部抽吸碎片和气体。抽吸管腔22也可以用作导丝、血管内成像导管和/或向远端推进的血管内放射治疗导管或再狭窄抑制药物的通道管腔。因此，连接器32可以有选择地容纳一个成像导管34，该成像导管具有能够邻近远端18和/或超出远端18地在导管体14内部向前推进的动脉粥样硬化物检测器36，而上述检测器通常包括血管内超声换能器、光学相干断层成像传感器、MRI天线或类似装置。成像导管34的成像连接器38将图像信号传递到显示装置39，通过这些图像信号允许进行围绕轴线20的动脉粥样硬化厚度的圆周测量。
连接器32还可以容纳一个再狭窄抑制治疗导管40，在这里治疗导管包括血管内放射导管。上述放射导管可以包括放射源42，其中放射源42在导管体14内部能够被再次向远端推进到可扩张结构26内或超出可扩张结构。
近端壳体28的第二连接器44和冲洗管腔24流体连通(参见图3)。第二连接器44可以被连接到冲洗流体源，用于引入导电或不导电流体、气体或类似物，理论上第二连接器44用于引入气体或肝素化盐水。第一和第二连接器32和44均可以可选地包括标准连接器，诸如Luer-LocTM连接器。在图2A中，示意性地说明了连接器44如何与真空抽吸源/灌注流体源45连接。
现在参考图2、2A和3，近端壳体28还容纳一个电连接器46。连接器46包括多个电连接，这些电连接均通过专用连接器52被电连接到电极50上。这就可以很容易地为电极50中的子集提供能量，通常是使用双极或单极RF能量为这些电极提供能量。因此，电连接器46通常通过连接器47被连接到RF发生器上，其中控制器允许能量被有选择地指向被接合管腔壁的偏心位置。当单极RF能量被使用时，患者接地(例如)可以由外部电极或导管体14上的电极提供。处理器49可以处理来自成像导管34的信号以产生显示装置39上的图像，处理器还可以协调抽吸、冲洗和/或治疗，而且处理器可以用图像自动记录治疗。
图3对可扩张结构26进行了详细说明。当可扩张结构26从限制护套中释放时，可扩张结构26可以弹性扩张；或是可选地使用牵引线、内导管体58或类似物，通过向远端18牵拉末端30(参见图2)，可扩张结构26也可以扩张。在这里可扩张结构26包括穿孔结构或篮，这种穿孔结构或篮具有一组其间带有开口或穿孔56的结构支撑件或元件54。例如，可以通过在柔软的管状材料上切割出细长的切口形成穿孔56，或是通过编织细长导线或带状物或类似物形成篮。
可扩张结构26通常包括近端部分60、远端部分62和位于其间的中间部分64。每一个电极50沿着中间部分64被安装在相关篮状元件54上，并且相关导体52从电极附近伸出。在阵列中，电极50围绕轴线20被环状分布，相邻电极优选被轴向偏移，理论上在近端和远端轴向位置之间被交错或交替。这就允许双极能量被指向位于相邻的圆周(轴向偏移)电极之间、相邻的远端电极之间、相邻的近端电极之间或类似位置。
在典型实施方案中，近端和远端阻隔件66、68随可扩张结构26的近端和远端部分60、62一起径向扩张。阻隔件66、68能够阻止相邻电极50产生的任何消融碎片和气体进入导管12以外的体腔。阻隔件66、68也允许在体腔内部建立至少是被部分隔离的消融环境，例如，用更有利的流体环境替代血管内的血液以限制电极和类似物的炭化。可选择的阻隔件可以被提供，用于替代阻隔件66、68(或与其一起使用)，这些阻隔件包括一个或多个轴向偏离该扩张部件26的球囊、如图11-13所示的弹性唇缘(lip)或类似物。在其它实施方案中，重塑可以在没有产生明显热消融碎片的情况下实现，和/或通过使用局部冲洗和/或抽吸流提供理想的治疗环境，这样一些系统就可以不再使用阻隔件。
现在参考图4和6A，可选择的实施方案可以在不同篮中使用不同的可扩张结构。在图4中，编织篮70包括安装在编织结构72上的电极50。尽管在一些实施方案中在注意电极电绝缘的情况下可以使用金属编织结构，但是在交叉金属编织结构变短时就可能存在问题。因此，编织部件72可以包括高温聚合物或不导电材料，诸如聚酰亚胺。例如，细长电极篮76可以包括沿篮状部件78的中心部分有选择地裸露金属表面形成的电极50，同时使用高温聚合物或类似材料使篮状元件的其余部分实现电绝缘，这样篮状支撑件就可以用作为电极提供能量的导体。篮76的径向扩张也可以用内部导管体58相对于体14的运动71示出。通过从篮上收回套管、牵引线或类似物，扩张也可以被实现。图5示出了成像导管34中位于可扩张结构76远端的血管内超声图像传感器36，并且为了清晰起见图中省略了成像导管的近端部分。还有其它可选择的可扩张结构可以被使用，包括电极阵列围绕球囊被环状安装的系统，上述系统可以减少消融区域中的血液污染。作为另一种选择，借助于轴向偏移球囊，受控消融环境可以利用位于扩张部件近端和/或远端的阻隔件维持，同时可选抽吸端口被再次设置在上述近端和远端阻隔件之间。
通过在超弹性合金管(诸如镍钛合金或NitinolTM管)上切割狭缝，典型可扩张结构26可以被形成。如图6B所示，可扩张结构54可以在电极和/或电极安装位置82附近具有被加宽的圆周宽度80。如图6A所示，如上所述，宽度80在电极安装垫(pad)82附近的局部加宽可以被轴向偏移。形成扩张部件54的狭缝和由此形成的扩张部件自身例如可以是0.8英寸长，同时扩张部件具有大约0.25英寸的圆周宽度。
现在参考图7A和7B，图中显示了具有折叠锥形式的可扩张阻隔件的侧视图和端视图。在这里阻隔件66包括用硅酮涂敷的编织NitinolTM线84，例如，通过将超弹性合金的编织物(诸如NitinolTM编织物)浸入液体硅酮并允许其变硬。然后，上述锥体可以被安装在可扩张结构的近端和远端部分。如上所述，各种可选择的阻隔膜可以被使用。图7C说明了具有内装式阻隔件77的篮75，其中阻隔件77被直接覆盖在篮上。阻隔件77包括聚氨酯，它可以具有相等高的抗撕裂强度。可选择的阻隔膜可以包括其它材料，诸如PTFE或类似材料。
现在参考图8和9，由聚酰亚胺合金扩张部件54支撑的典型电极50可以用高温聚合物覆盖。如上所述，导体52从电极50的近端伸出。高对比度的射线不透标记(诸如金、铂、铂/铱合金和类似物)可以被粘贴到这些支撑件上或附近。这些标记也可以用作电极。
参考图10A到10E，图中说明了导管系统10用于从血管内重塑和/或清除偏心粥样斑的使用。如图10A所示，进入治疗部位通常包括在血管V内将导丝GW推进到动脉粥样硬化物AM的靶区(target region)，而更为常见的是将导丝GW向远端推进超出动脉粥样硬化物AM的靶区。有多种导丝可以被使用。为了进入已经完全闭塞的脉管，导丝GW可以包括能够从任意商业途径获得的适合穿过这种完全闭塞的导丝，包括具有前视光学相干反射测量术(reflectrometry)和RF消融的Safe-CrossTM RF系统导丝。在动脉粥样硬化物AM没有导致管腔完全闭塞的地方，即使有其它的有利特征可以被提供，也不需要在导丝GW中提供上述功能。例如，导丝GW可以包括远端球囊，用于将导丝固定在恰当位置并且进一步阻止消融碎片和类似物的运动。导丝GW可以在荧光检查(或其它)成像下被定位。
如图10A和10B所示，导管12通常是朝着闭塞的远端部分在导丝GW上被向远端推进，并且被定位在动脉粥样硬化物AM附近。可扩张结构26在血管的管腔内部径向扩张，使得电极50径向接合动脉粥样硬化物AM。例如，通过牵拉穿过导管体14延伸以和扩张体26的远端部分62(直接或间接)连接的牵引线(参见图3)，可扩张结构26可以被扩张。作为另一种选择，内导管体58可以相对于外导管体14向近端移动，同时内导管被再次连接到扩张体的远端部分。此外还存在其它的可选方式，包括从扩张体周围收回护套并允许扩张体向外侧径向伸展。至少在一些实施方案中，不管是从导管12的近端激励，还是简单地通过释放扩张体，限定扩张体的结构部件均可以包括用于向外侧径向扩张的弹性或超弹性材料，诸如通过热定形的超弹性NitinolTM金属、聚酰亚胺或类似物。在一些实施方案中，在消融导管被定位和/或篮被扩张后，导丝GW可以被收回。如图10B和10C所示，由于动脉粥样硬化物AM围绕导管12偏心分布，所以电极50中的一些电极可以和管腔壁W直接接合。
成像导管34被设置在导管12的管腔中，这样检测器42可以延伸到动脉粥样硬化物AM附近。成像导管在导管12内和/或经由导管12工作，以便如图10C所示测量和导管12共轴的动脉粥样硬化物的厚度，而且测量通常在多个轴向位置上执行以便测量血管内动脉粥样硬化物AM的轴向变化，上述多点测量通常在近端进行。如图10C所示，在许多情况下动脉粥样硬化物AM在脉管壁内是偏心分布的。应当理解当测量分布指示闭塞是偏心时，没有任何一部分血管壁需要完全不被动脉粥样硬化物覆盖，这是因为沿一段血管或一侧血管的粥样斑相对较薄层的厚度与血管V对侧的动脉粥样硬化物较厚层的厚度相差很大。在一些方法中，只是在治疗开始后，沿一侧所有粥样斑的重塑和/或消融才可以导致电极/脉管壁的接合。
在一些情况下，成像导管34可以允许对血管内的动脉粥样硬化物、斑块、组织、病变和类似物进行识别和/或特征描述。例如，成像导管34可以确定用于治疗的目标斑块的轴向和/或圆周位置。在针对动脉粥样硬化斑块进行治疗以便增大管腔血流量的地方，治疗可以被修改以提供管腔直径和血流量上的短期和/或长期增加。在导管34识别出圆周和/或轴向局部易损斑块的地方，可以对易损斑块采取恰当的治疗以阻止溶栓物质的有害释放，通常是通过加厚易损斑块的纤维帽使斑块变得不容易破碎、减少从易损斑块高脂池中释放的危险物和释放量或采取类似措施。因此，导管34可以用于提供和组织学信息类似的信息，以便指示粥样斑的组成(例如，通过识别和定位纤维帽、平滑肌细胞、脂质池、钙化和类似物)。血管内超声导管现在能够进行上述粥样斑的特征描述，并且这些特征描述也可以由光学相干断层成像血管内导管、血管内MRI天线和其它基于导管的成像系统提供，或由MRI系统这样的无创成像方式提供。
适合在本导管系统中使用的成像导管可以从众多生产厂商那里购买。例如，合适的技术和/或导管可以从SciMed Life Systems and Jomed-Volcano Therapeutics(血管内超声导管的提供商)、Light LabTM Imaging(开发和生产用于血管内成像的光学相干断层成像导管)、Medtronic CardioRhythm和其它厂商那里购买。此外，其它可选择的技术也可以被使用，包括超高速磁共振成像(MRI)、电阻抗粥样斑深度测量、光学相干反射测量术和类似技术。
本发明的系统、装置和方法可以有选择地使用成像技术和/或动脉粥样硬化物检测器装置，其中上述动脉粥样硬化物检测器装置至少被部分(或可选地被完全)设置在体腔外面，可选地被设置在患者体外。可以使用的无创成像方式包括X线或荧光检查系统、MRI系统、外部超声换能器和类似系统。可选地，外部和/或血管内动脉粥样硬化物检测器也可以用于提供温度信息。例如，具有MRI天线的系统可以检测组织温度，这样治疗穿透度的图像指示可以被显示在系统显示器上。组织温度信息也可以从超声和/或光学相干断层成像系统中获得，并且温度信息可以用作指导后续治疗、选择治疗组织(例如，通过识别热或易损斑块)和类似情况的反馈。
和导丝GW的定位以及导管12的推进一样，通过荧光检查或其它成像方式，成像导管34的传感器30的定位可以更便利，通过与传感器36相邻的导管34的射线不透标记，并且通过可扩张结构26的射线不透结构(或相应的射线不透标记设置在可扩张结构26上或附近)，和/或通过使用射线不透的电极，传感器36相对于可扩张结构26的定位可以被简化。
通过扩张血管V内的可扩张结构26，可选的近端和远端阻隔件66、68(参见图3)可以形成血管内至少被部分隔离、优选被基本隔离的环境。如上所述，通过从设置在近端和远端阻隔件66、68之间的抽吸管22的一个端口抽吸血液，并用理想流体冲洗隔离环境，上述环境可以被改变以改善随后的重塑和/或消融。当抽吸和/或冲洗被提供时，抽吸和/或冲洗可以被执行，可选地被同时执行，以便在受控环境内产生用于清除任何汽化气体、消融碎片和类似物的流。
现在参考图10C和10D，圆周成像通常表明重塑和/或消融应当以脉管壁W的偏心部分或区域R为目标。为了帮助电极和环状粥样斑分布的配准，可扩张结构26的一个支撑件应具有可辨识图像，允许支撑件用作旋转对齐的关键部位。通过使用血管内成像，诸如血管内超声(IVUS)、光学相干断层成像(“OCT”)、血管内MRI和/或类似方式，可选地通过使用外部成像，诸如荧光检查法、磁共振成像(“MRI”)或类似方式，对电极进行的配准可以被完成。电子配准也可以被使用。根据上述信息，RF能量被指向位于区域R内部的电极。这些主动供能的电极限定了整个电极阵列中的一个子集，并且通过使用下文描述的控制器，上述电极子集的选择可以被实现。
在血管内消融动脉粥样硬化物的机理已经被很好地阐述，这包括Slager等人1985年6月在J.of Amer.Cardiol.杂志第1382-6页发表的文章“Vaporization of Atherosclerotic Plaque by Spark Erosion”；和Strategic Business Development公司1990年出版的Stephen M.Fry编写的书籍“Thermal and Disruptive Angioplasty：a Physician’s Guide；”，在此全部引入并作为参考。在本发明的系统中修改和/或使用的适当汽化方法和装置在美国专利Nos.5098431、5749914、5454809、4682596和6582423以及其它引用中得到了描述。这些引用中的每一个引用的全部公开在此引入并作为参考。
如图10所示，对被选电极50的供能可以导致动脉粥样硬化物AM的汽化，这样动脉粥样硬化物随流经导管12管腔的抽吸流F从血管中被清除。同时存在的冲洗流可以帮助维持导管近端和远端阻隔件之间的环境，并且这两个流允许气体G和消融碎片被带走，并阻止上述栓子在血管V内的释放。流体也可以用作冷却流，用于限制对其它组织的加热和继发伤害，循环流通常应该至少低于体温，可选地可以等于或低于室温。
现在参考图10E，如上所述，不需要从血管内彻底清除所有的粥样斑或动脉粥样硬化物。提供有效直径至少是原有标称管腔直径80％或85％的开通管腔可以满足需求。重塑治疗可以提供在大约30％到大约50％范围变化内的急性有效开通直径。在一些实施方案中，由供能电极或其它能量定向表面对动脉粥样硬化物造成的损伤可以引起受损组织病变的继发吸收，以便将治疗结束后脉管的进一步开通当作治愈过程的一部分。
为了加强远期效果并阻止血管V治疗区域的再狭窄，再狭窄抑制导管40可以经过导管12的管腔被推进，这样放射源42可以照射血管的治疗区域。合适的血管内辐射导管可以从NovosteTM、Guidant、Johnson&Johnson及其它公司购买。和目前那些在药物涂层支架中使用的药物类似的再狭窄抑制药物也可以经过导管12的管腔被推进，可选地同时近端和远端阻隔件再次帮助维持血管内的受控环境带，这样全身药物输送可以被限制或被避免。除了在药物涂层支架上使用的已知再狭窄抑制药物以外，引起血管舒张的药物可以被使用。已知的再狭窄抑制药物也可以被使用，诸如RapamycinTM(雷帕霉素)。
在一些实施方案中，当导管12在血管内移动时，可扩张结构26可以保持紧靠血管壁W和/或动脉粥样硬化物AM的扩张状态，其中导管12通常是在消融治疗期间或间期被向近端牵拉。例如，在测量血管温度以便检测系统内的易损斑块时，径向扩张穿孔篮的类似运动可以被使用，其中上述系统现在由Volcano Therapeutics开发和/或销售。作为另一种选择，篮可以被反复收缩，导管12的轴向运动可以用于改变篮的位置，并且篮可以沿着动脉粥样硬化物AM在多个治疗位置的每一个位置上连续扩张。围绕导管12圆周重复执行的血管内成像或其它动脉粥样硬化物厚度测量可以被使用，并且重塑和/或消融通常会被暂时中止以便允许在消融期间对图像进行间歇性采集。最终图像可以用于确认重塑和/或消融已经成功。
现在参考图11到21，各种可选导管结构被示意性地说明，在这些结构中有许多结构为重塑和/或消融提供了已经被加强的血管内微环境或受控环境带。各种栓子抑制阻隔件也被描述和/或说明，包括可以轴向偏离消融电极的硅橡胶球囊、柔性唇缘或可扩张圆锥。例如，参考图11和12，和图2所示系统类似的系统可以使用重塑和/或消融套管102，该套管具有近端轮毂104并在护套的轴向管腔中容纳图像导管和导丝GW。微环境由微腔唇缘106提供，上述微腔唇缘可以包括硅或类似材料。双极电极50(尽管不需要但)可以产生气体和/或其它消融碎片，这些气体或碎片由硅唇缘帮助容纳。轮毂104的真空端口108和真空端口110流体连通，同时含盐流体注入端口112和盐水注射通道114可以一起用于控制和/或改变用于重塑和/或消融的微环境。如图13所示，通过使用将导管护套102、双球囊或类似物完全包围起来的类硅唇缘116，替代的微腔被形成。如图14所示，这种结构可以和支撑RF电极的篮118结合，以便在微腔内提供电极接触。篮可以可选地包括NitinolTM形状记忆合金。
现在参考图15，更一般而言，重塑/消融套管102可以支撑提供射频能量的电极50，并且可以提供一个或多个管腔用于共轴和/或双轴插入成像导管34(诸如IVUS导管)和/或导丝GW。成像导管34可以拥有具有阵列120形式的换能器。
现在参考图16，和图11和12所示套管类似的重塑/消融套管102(这里是在横截面上)具有电极导线管腔122、盐水注射管腔124和真空端口110的开口，其中真空端口110的开口通向护套102的工作管腔，成像或IVUS导管34和导丝GW被设置在护套102的工作管腔中。硅唇缘或阀126允许将真空传递给微环境。
其它可选择排列在图17和17A中得到说明。在图17的实施方案中，除了外电极50以外，和组织接触进行治疗的内电极128被用在双极系统中。图17A示意性地说明了具有球囊132(诸如乳胶球囊)的球囊导管130的使用。电极50被安装在乳胶球囊的表面上，供被选电极对使用。因此，球囊(而不是篮状结构)可以用作携带电极或其它能量传递表面的径向可扩张结构。
图18示意性地说明了从大外形结构被压缩到小外形结构的可扩张篮134。通过提供合适的边缘，篮可以可选地被用作切割篮，和/或篮可以捕获其中的栓子。图19说明了重塑/消融套管102，在该套管中成像导管34可以来回移动用于成像，并且在该导管中硅橡胶球囊135被设置在治疗碎片的远端用于实现栓子捕获。图20说明了和图17A所示球囊132类似的另一种电极传递球囊138，并且电极50具有从其中向近端延伸的柔性管腔延伸。图21示意性地说明了位于微腔内部的RF电极，其中上述微腔由护套102的近端和远端阻隔件140、142提供，其中电极50的位置在微腔中被激励。
现在参考图22和23，可选择控制器92a、92b使用由RF发生器94供应的RF能量有选择地为导管12的电极供能。有多种RF能量类型可以被使用，包括500kHz的短脉冲群(burst)、不同种类的波形和类似能量。在控制器92a中，简单刻度盘96被转动用于指向待供能的预定电极对。或是通过电学方式，或是通过提供在血管内成像显示器上呈现清晰图像的电极、电极支撑部件或附加标记，“基准(key)”电极可以和血管内成像系统配准。这就简化了沿粥样斑的一个和多个偏心电极对的选择。有利地，导管12不需要被旋转到正确方位，以便准确重塑和/或消融预定的偏心动脉粥样硬化物。控制器92b包括类似功能，但是它允许操作人员选择多个电极用于驱动其间的双极RF能量，并且在允许多个电极被同时供能的问题上提供了更大的灵活性。图23和24分别说明了与图21和22所示配置类似的单极控制配置。患者地可以通过患者接地金属板、距离篮26近端2至5cm的环状电极或类似物实现。需要再次重申，不需要对导管进行旋转以使其有效侧与目标粥样斑邻接，这是因为可以通过电极选择控制器选择各种偏心消融方位。
图26和27示意性地说明了在本发明所述导管和方法中使用的可选择流体流动配置。在图26的实施方案中，从可扩张体26近端延伸出来的管状体150包括一个或多个冲洗端口152，这些冲洗端口在这里被设置在可扩张体的近端。抽吸端口154包括限定导丝和/或成像导管管腔156的管状体。冲洗流可以向远端流动，其流动方向也可以是体腔内血液流动的方向。冲洗流可以通过抽吸端口被抽走。在图27的实施方案中，管腔154用于抽吸，并且用作导丝和/或成像导管。
图28A-D对可选择控制器进行了说明。上述控制器允许操作人员为每一个电极选择是否继续维持电极的不工作状态，还是将电极电连接到能量源(诸如RF发生器或类似装置)的第一极(pole)(有时被称为极A)，或是将电极电连接到能量源的第二极或极B。上述控制器允许多种供能电极结构，包括假单极模式，即除一个电极外其它所有电极均被连接到能量源的一个极(极A)而剩下的那一个电极则被连接到另一极(极B)。如图28A所示，控制器160允许测试用于RF重塑和/或消融的许多电极结构，尤其是那些包括两个或多个电极的电极结构。图28B详细示出了开关面板162。每一个电极(在该实施方案中，高达8个电极)被电连接到从1到8进行编号的3路开关，拨动到中间位置的开关表示电极未和任何一极发生连接，同时拨向+号的开关表示相关电极通过控制器被连接到红色RF连接器。同样，拨向-号的开关表示相关电极被电连接到控制器箱的黑色RF连接器。
如图28C所示，和开关3-8有关的电极未和任何一极发生连接，电极1被连接到红色RF连接器，电极2被连接到黑色RF连接器。在RF发生器的激励下，电极1和2之间将循环双极RF能量。在图28D中，电极5-8未被供能，同时电极1和3被连接到红色RF连接器。电极2和4被连接到黑色RF连接器，这样在RF发生器的激励下，将在电极1和3之间以及电极2和4之间循环双极RF能量。
图29A-29H说明了典型的自膨胀篮。如这些附图所示，电极可以作为制成篮的支撑件172的一部分被制造，例如，如图29B和29E所示，可以将在支撑件轴向中间位置设置的每一个支撑件的局部加宽部分174的径向朝外面用作电极。每一个臂可以由单片材料构成，可选地包括NitinolTM镍钛成形记忆合金，并且这些支撑件可以可选地从NitinolTM管中激光切割而来。例如，电极/篮可以用诸如聚酰亚胺这样的高温聚合物涂敷。可以通过在相关支撑件172的所需部分禁止涂敷或清除涂层(如图29E所示)形成电极174，这样电极表面被暴露用于接触动脉粥样硬化物。这些支撑件可以彼此独立并利用绝缘材料进行结构支撑以形成篮170，其中上述绝缘材料可以是紫外线(UV)固化或热缩套管、聚乙烯、NylonTM(尼龙)或类似材料。
每一个支撑件172均可以用于在电极表面174和从支撑件近端向控制器伸出的电导体之间传递能量。图29C示出了用于连接上述导体的近端极板(pad)，同时图29D对远端结构极板178进行了图示。如图29F所示，相邻电极174可以被轴向偏移或交错排列。沿每一个支撑件172的绝缘涂层可以被禁止或是从近端极板176的内表面上被清除，这样可以通过点焊或类似方式帮助进行相关导线的连接。包括聚对二甲苯基涂层在内的可选择绝缘材料也可以被使用，同时用于将支撑件172附着在导管体上的可选择方法可以被使用，其中这些方法包括使用绝缘UV固化的粘合、在聚乙烯中嵌入极板结构和其它类似方法。
图29G说明了用于将篮170的支撑件172固定在导管体180上的典型结构。
现在参考图29F和29H，为篮170的被选电极174和图像或其它动脉粥样硬化物测量的旋转配准提供可辨识图像的可选择标记能够被理解。在该实施方案中，作为电极1引用的电极174i可以具有设置在相关支撑件172i上的射线透不过的标记182。支撑相关第二电极174ii的支撑件172ii可以具有两个射线透不过的标记182，这两个标记提供了允许所有电极被确切定位(reference)的圆周不对称计数指示器。电极50的形状可以发生变化，例如，如图29A-29G所示电极174可以比支撑件172的其它部分宽。
如上所述，重塑通常通过使用冲洗和/或抽吸流而被执行。在许多实施方案中，冲洗端口指引流体(诸如盐溶液)从冲洗管腔进入篮的内部。抽吸端口可以提供抽吸管腔和篮内部之间的流体连通。这两个流体流中的一个或全部可以被连续驱动，或者在治疗之前、期间和/或之后可以可选地被脉动驱动。在一些实施方案中，抽吸和/或冲洗流可以急剧或同时出现，以便在冲洗端口和抽吸端口之间循环。可选地，流可以将消融碎片输送到抽吸端口，在这里碎片可以通过抽吸管腔排出。这里可以存在冲洗系统和抽吸系统之间的协同，这样冲洗流体可以继续被限制在和篮紧密相邻的区域中，以便当篮在血管内扩张时阻止消融碎片的栓塞。例如，这种协同可以阻止消融碎片的远端运动，和/或可以避免使用远端和/或近端阻隔件或膜。在一些实施方案中，冲洗端口和抽吸端口之间的流体循环可以在电极附近建立一个有效的无血环境，以便于进行重塑和/或消融、动脉粥样硬化组织的成像和类似方面。
现在参考图30A和30B，从本发明的导管系统和结构中被指引的能量的控制可以可选地使用热电偶和其它温度传感器结构。诸如K型热电偶(+CH/-AL)的热电偶可以被附着在可扩张结构的一个或多个支撑件上或附近，用于提供温度测量。例如，上述结构可以提供组织温度测量、血液温度测量、治疗温度测量和/或其它温度测量。
可选地，温度测量结构也可以用作RF电极，例如通过使用一个或多个如图30A和30B所示的结构。在图30A所示的实施方案中，热电偶182能够被连接到RF能量源184上，或是通过开关188被连接到温度计186上。图30B说明了一个与图30A类似的实施方案。
现在参考图31，可选择导管系统190包括由支撑件192支撑的多个电极50。当支撑件192穿过护套194被延伸到远端时，支撑件192径向扩张，这样电极的环状阵列是可折叠的。球形末端196包括朝向近端的高压喷管(jet)198，而且球形末端可以用作一极，而被选电极50则被用作另一极。可选的，双极能量可以在电极50等之间被驱动。可选地，诸如滤网这样的近端阻隔件200可以用于阻止任何碎片的运动和/或捕获这些碎片。
当RF电极被供能时，高压喷管也可以被激励，以便提供盐水冲洗。通常通过使用和护套194连接的抽吸源，文丘里效应可以经由导管管腔带动碎片向近端传送以便排出。碎片可以在阻隔件200中被捕集，其中上述阻隔件可以包括滤网、实心片材、网状物或类似物。在一些实施方案中，低压喷管可以从相邻球形末端196中获取，用于替代高压喷管。
现在参考图32A-32D，当可扩张结构轴向弯曲时，例如当其沿体腔内的弯曲被扩张时，可选择的可扩张结构可以避免可扩张结构的纽结或变平。在图32C的实施方案中，线圈或螺旋状可扩张结构202具有小轮廓结构204和大轮廓结构206，并且通过远端208和/或近端管状体210的相对彼此的扭转、通过牵拉/释放机构或类似方式，线圈或螺旋状可扩张结构202可以被展开和/或被收缩。如上所述，抽吸和/或冲洗可以经由近端管状部件210被提供，并且线圈结构可以包括一个环或多个环，以便当扩张到大轮廓结构206时提供电极50的一个或多个环状排列。在图32D的实施方案中，可膨胀的可扩张结构212包括构成管状膨胀球囊的轴向支撑件和/或环，以便允许可扩张结构从小轮廓结构扩张到所示的大轮廓结构。
在图33-35中示意性地说明了其它可选择的可扩张结构和能量传递面。在图33所示的微波治疗装置216中，篮的每一个支撑件可以包括螺旋状微波天线，并且天线的内表面被屏蔽以避免向导管轴线发射能量。可选择的微波天线也可以被使用，包括允许通过改变天线焦点进而改变能量传递面和目标组织之间深度的单向天线。上述聚焦微波装置可以包括能够绕导管轴线旋转、轴向移动和进行类似运动的天线。
在图34和35的实施方案中，导管体再次支撑一组支撑件218、220，并且导管体也具有多个冲洗或冲刷管腔。这些位于导管体内的冲洗管腔和沿支撑件延伸(在一些情况下被整合到支撑件中)的管状结构流体连通，这样流体冲洗端口222将盐水或其它流体指向电极50或微波天线224。能量传递面上的电外科能量可以使用支撑件结构传送，或者导线226可以沿支撑件延伸到能量传递面。在图35的实施方案中，显示了沿微波天线224内部的屏蔽层228，该屏蔽层可以限制被指向成像导管的微波能量。对于将微波天线用作能量传递面的实施方案，在某一个时刻，环状阵列中只有一个天线可以被供能，这样可以避免沿导管体的导体之间的相互干扰。
现在参考图36，这里描述的导管系统的控制器可以允许将不同的功率级分配给不同的电极对。例如，响应如图36所示的动脉粥样硬化物AM的圆周分布，控制器可以将50瓦的能量指向第一电极230，将30瓦的能量指向第二电极对232，并且将仅有10瓦的能量指向第三电极对234。如上所述，其它电极可以没有能量指向那里。在一些实施方案中，可以通过控制占空比提供指向不同电极的不同功率，例如，用50％的时间为一个或多个电极供能可以提供50瓦的能量，用30％的时间为电极供能可以提供30瓦的能量，其它类似情况不再一一列举。
现在参考图37A-37C，通过在金属结构(诸如NitinolTM构成的篮)的内部设置了图像检测结构，许多成像模式(包括血管内超声、光学相干断层成像、血管内MRI和类似方式)可以至少被部分遮挡或被削弱。因此，这对于生成可供选择可扩张结构是有利的，诸如包括塑料或聚合物的篮。考虑到由本发明所述系统的电极所产生的热量，它可能对上述聚合物篮状结构240包括高温聚合物(诸如聚酰亚胺)有利。可选择的篮状结构可以包括HDPE、PET、NylonTM、PEBAXTM和类似物。如图37B所示，篮状支撑件的近端可以在接头244处被粘合到杆242上。成像导管导向装置246可以经由篮状结构248的远端延伸，并且篮的远端能够自由地沿导向装置轴向滑动。牵拉线250可以被固定在远端248上，这样拉动牵拉线可以径向扩张篮240，同时牵拉线可以在近端杆242的内部运动。通过推动牵拉线，篮可以被收缩恢复到小轮廓结构，或者篮可以包括促使篮恢复到小轮廓结构的偏置装置。为了避免成像性能的退化，和钓鱼线类似的聚合物受拉部件可以用作牵拉线。在典型实施方案中，极线包括NitinolTM，NitinolTM具有足够的压缩刚度可以推动篮恢复到它的小轮廓结构。
篮240可以通过从聚合物材料上切割出支撑件而被形成，而且远端部分248优选保持未被切割状态。支撑件的近端可以在形成接头244之前被分开，而且环状RF电极可以沿每一个臂被滑动，并沿篮的中间部分被粘合到预定结构上。
图38A-38H说明了典型的治疗方法。在图38A中，导管系统260包括在动脉粥样硬化物检测和治疗导管264上覆盖护套262的篮。在该实施方案中，外部篮状护套262径向束缚篮266，如图38B所示，当篮从外部护套中被释放时篮被偏压以便径向扩张。在一些实施方案中，篮可以在外部套管被收回后被扩张，诸如通过拉动牵引线、将导管的一部分相对于另一部分进行旋转，或采用类似方式。不管怎样，当篮在脉管V内扩张时，篮的电极50均会和周围的脉管壁接合。在成像导管中位于篮266附近的成像换能器用于评价脉管V，而且检测/治疗导管系统264沿动脉或脉管V被向近端牵拉，其中上述成像导管设置在治疗导管的管腔中。
当成像导管如图38C所示检测动脉粥样硬化物AM时，合适的子集(可能只包括一个电极50)如图38D所示被激励用于重塑动脉粥样硬化物AM，而且被开通的脉管管腔尺寸会在治疗期间逐渐增加。导管向近端被牵拉到下一个粥样斑，粥样斑被再次检测并被治疗。图38F示意性地说明了治疗前的有限开通管腔的横截面，图38F也说明了导管264的盐水冲刷或冲洗管腔268。图38G示意性地说明了治疗能量和脉管V的开通管腔直径的逐渐增加。在愈合反应逐渐增大开通管腔直径以后，如图38H所示的长期开通管腔效果可以被提供。
现在参考图39A和39B，图中显示了凝胶动脉模型270中的偏心物质清除。在测试前，动脉模型包括如图39A所示的管腔272。测试用偏心治疗导管274具有支撑电极环状阵列的扩张篮，导管274被插入到管腔272中，同时扩张篮支撑电极与管腔壁接合。测试导管274的被选电极被供能，以便电学治疗凝胶动脉模型274，由此实现凝胶模型的偏心重塑，在这种情况下可以通过沿管腔272的一侧清除其中的偏心体积276，从而实现偏心重塑。通过有选择地为测试导管274的电极提供能量，可以控制被清除物的方向和数量。
现在参考图40，图中说明了典型的导管系统280。在该实施方案中，导管体282仅包括一个单独的管腔，该管腔足够大足以容纳成像导管而且可以被用作为冲洗端口284提供冲洗流体的冲洗管腔。管腔可以在冲洗端口284的远端减小直径，直径减小的部分286使管腔内只能容纳成像导管，这样可以通过多个冲洗端口向外侧径向指引冲洗流体。该实施方案在使用图38A-38H所示的方法重塑动脉粥样硬化物时尤其有用，在这些方法中适度加热可以在不需要抽吸的情况下改善脉管大小。
导管体282可以包括编织杆(braided shaft)，其中导线(例如，铜导线或铍铜导线)用诸如聚酰亚胺层或类似涂层的高温和/或高强度绝缘材料覆盖。编织导线可以被夹在构成导管体282的杆的各个材料层之间。例如，所述杆可以包括多个聚乙烯层、一个内部TeflonTM(特氟隆)PTFE层、一个外部尼龙层和类似层。
杆282的导线可以被编织，以便在电流通过导线时抑制导线间的电容性损耗。当一条导线将电流从能量源输送到导管系统的电极，一条导线将电流从电极输送回能量源时，如果这两条导线不平行，而是存在一个夹角，理论上是成直角，电容性损耗可以被降低。通过使用合适的间距或每英寸许多波峰来编织导线，上述情况可以被实现。导管系统280的篮状结构170可以被包括在内，并且篮状结构在图29A-29H中得到了详细描述。导丝286可以穿过篮170延伸，而且可以包括对成像导管透明的材料，可选地包括HDPE、PET或类似物。
此外，可以获得其它可供选择的实施方案。例如，使用RF能量重塑动脉粥样硬化物的另一种方式可以是使用不同的RF信号为多个相邻电极提供能量，以便将相邻电极用作相控阵。使用阵列相邻元件信号间的相长干涉和相消干涉，相控阵能够在预定方向上指引或控制电磁信号。通过控制相邻信号的相位，电极的相控阵可以提供聚焦和/或可控RF信号。
除了控制转向和方向性外，调整相邻RF电极的相位可以允许一部分或大部分RF能量聚焦在动脉粥样硬化物内部的所需深度D上，同时使用信号间的相长干涉和相消干涉，禁止电极表面和深度D之间的RF能量传递。例如，上述系统可以用于保护斑块帽，从而减少再狭窄。禁止帽的加热并将能量聚焦到斑块内部可以降低可能导致再狭窄的加热的免疫反应。因此，禁止帽的加热可以减少再狭窄。
通常，本发明可以使用高弹性的可扩张结构，尤其是使用由穿孔分开的结构部件构成的可扩张结构，以便限定“篮”。在动脉粥样硬化物清除之前、期间和/或之后，上述结构能够和动脉直径保持一致。这种扩张性允许电极直接接触粥样斑，尽管本发明的系统也可以使用传导流体环境以完成RF能量路径，或是相反可以使用非传导流体环境以增强指向组织的能量。多个电极能够围绕可扩张结构的中间部分被环状分布，而且这些电极的子集能够被激励以允许偏心的组织重塑和/或消融。
通过血管内成像，粥样斑可以被识别并被瞄准，而且这些能力可以被整合到重塑和/或消融导管中。优选地，血管内成像能力可以用在独立导管中，该独立导管可以在消融导管中推进并且可以从消融导管中撤出。通常，上述血管内成像能力允许对治疗过程进行监测，这样可以避免壁穿孔，同时理论上可以(在治疗完成时，或是在继发组织愈合之后)将闭塞减少到小于等于原有脉管总直径的15％。此外，消融导管还可以允许使用抗再狭窄治疗的局部放射疗法或药物输送。消融导管可以包括相对较大的管腔，该管腔允许有选择地使用血管内成像系统、辐射传递或其它治疗导管、碎片和汽化气体的抽吸，而且这些用途通常被顺序使用。导丝可以使用上述或独立管腔，而且导丝可以被撤出以允许再狭窄和/或成像导管进入。
为了起到说明作用和便于理解，已经较为详细地对典型实施方案进行了描述，但是本领域的技术人员应当理解各种修改、改进和变化可以被使用。因此，本发明的范围仅受后附权利要求的限制。

Claims (19)

1.一种对患者血管中动脉粥样硬化物进行偏心重塑的导管系统，该系统包括：
细长柔性导管体，该导管体具有近端和远端及位于其间的轴线；
位于导管体远端附近的径向可扩张结构；
多个能量传递面，当可扩张结构扩张时每一个能量传递面沿径向定向，从而提供绕血管轴线沿圆周分布的能量传递面阵列；
与导管体连接的动脉粥样硬化物检测器，用于沿着血管检测环状动脉粥样硬化物；
和能量传递面电连接的能量源；和
将所述能量源连接到所述阵列的控制器，用于响应检测到的动脉粥样硬化物有选择地为能量传递面的偏心子集提供能量，所述能量源为能量传递面提供能量，以便通过对血管进行温和加热而将血管外层的温度限制到不超过63℃，来沿着血管偏心重塑检测到的动脉粥样硬化物。
2.根据权利要求1所述的导管系统，其中导管体具有在所述近端和远端之间延伸的管腔。
3.根据权利要求2所述的导管系统，进一步包括在导管体近端处和管腔流体连通的抽吸连接器。
4.根据权利要求3所述的导管系统，进一步包括分别设置在能量传递面近端和远端的近端碎片阻隔件和远端碎片阻隔件以及在所述近端碎片阻隔件和远端碎片阻隔件之间设置的抽吸端口，该抽吸端口用于在动脉粥样硬化物重塑期间清除碎片。
5.根据权利要求2所述的导管系统，其中动脉粥样硬化物检测器至少包括下述装置中的一个：
设置在管腔中的血管内超声导管；
设置在管腔中的血管内光学相干断层成像导管；和
设置在管腔中的血管内磁共振成像导管。
6.根据权利要求2所述的导管系统，进一步包括在导管体近端和导管体远端之间延伸的冲洗管腔。
7.根据权利要求2所述的导管系统，进一步包括可以在管腔内向远端推进的再狭窄抑制器，以便抑制血管再狭窄。
8.根据权利要求7所述的导管系统，其中再狭窄抑制器包括具有放射源的近距治疗导管。
9.根据权利要求1所述的导管系统，其中径向扩张体包括多个柔性支撑件，并且其中能量传递面限定一圆周定向的阵列。
10.根据权利要求9所述的导管系统，其中径向可扩张结构的支撑件具有设置在其间的穿孔以便限定一可扩张篮，其中该可扩张篮具有近端部分和远端部分以及设置在其间的中间部分，所述电极阵列沿该中间部分受到支撑以便当所述篮在血管内被扩张时接合邻近的动脉粥样硬化物，并且进一步包括和篮内部流体连通的抽吸端口。
11.根据权利要求10所述的导管系统，进一步包括可以在血管内部在电极远端展开的远端膜，以便阻止碎片的远端运动，和可以在电极近端展开的近端膜，以便阻止碎片的近端运动，其中所述膜阻止血液和重塑过程的相互作用。
12.根据权利要求11所述的导管系统，其中远端膜由篮的远端部分支撑以便随其径向扩张，并且其中近端膜由篮的近端部分支撑以便随其径向扩张。
13.根据权利要求12所述的导管系统，其中近端膜和远端膜中的至少一个包括轴向偏离所述篮的球囊。
14.根据权利要求1所述导管系统，其中所述电极包括一个阵列，该阵列至少有3个绕轴线圆周分布的可选择电极，并且包括一控制器，将能量源连接到电极阵列，用于响应检测到的动脉粥样硬化物有选择地为电极阵列的偏心子集提供能量。
15.根据权利要求14所述的导管系统，其中每一个电极均包括一个由可扩张结构的相邻支撑件支撑的金属表面，同时相关导体向电极近端延伸，以便将电极表面电连接到控制器。
16.根据权利要求1所述的导管系统，其中控制器通过将RF能量和微波能量中的至少一个指向所述能量定向面的子集，有选择地为该能量定向面的子集提供能量。
17.根据权利要求1所述的导管系统，其中动脉粥样硬化物检测器包括超声换能器或光学相干反射器。
18.根据权利要求1所述的导管系统，进一步包括连接到动脉粥样硬化物检测器的显示装置，该显示装置显示围绕导管轴线分布的环状动脉粥样硬化物厚度的图像。
19.一种对患者血管中动脉粥样硬化物进行偏心重塑的系统，该系统包括：
具有近端和远端以及位于其间的轴线的细长体；
位于导管体远端附近的径向可扩张结构；
当可扩张结构在所述血管内扩张时定向成沿着血管在径向对抗所述动脉粥样硬化物的多个电极，从而限定出轴对称的电极阵列；
与所述细长体相连的用于对所述动脉粥样硬化物进行圆周测量的动脉粥样硬化物检测器；和
与电极电连接的能量源，该能量源有选择地为电极的偏心子集供电，以便通过温和加热到在50℃到60℃范围内的温度来偏心重塑所测量到的动脉粥样硬化物。
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