CN102271603A - 得知或未得知组织形态的选择性能量积累 - Google Patents

得知或未得知组织形态的选择性能量积累 Download PDF

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CN102271603A
CN102271603A CN2009801530341A CN200980153034A CN102271603A CN 102271603 A CN102271603 A CN 102271603A CN 2009801530341 A CN2009801530341 A CN 2009801530341A CN 200980153034 A CN200980153034 A CN 200980153034A CN 102271603 A CN102271603 A CN 102271603A
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R·T·古斯特斯
L·孔斯特马纳斯
A·G·布兰克
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Vessix Vascular Inc
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Minnow Medical Inc
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    • A61B18/18—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body by applying electromagnetic radiation, e.g. microwaves
    • A61B18/20—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body by applying electromagnetic radiation, e.g. microwaves using laser
    • A61B18/22—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body by applying electromagnetic radiation, e.g. microwaves using laser the beam being directed along or through a flexible conduit, e.g. an optical fibre; Couplings or hand-pieces therefor
    • A61B18/24—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body by applying electromagnetic radiation, e.g. microwaves using laser the beam being directed along or through a flexible conduit, e.g. an optical fibre; Couplings or hand-pieces therefor with a catheter
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Abstract

在知道或不知道组织形态的情况下，使用能量在动脉组织中的选择性积累，用来加热与体腔相邻的身体组织区域的方法和系统，该区域具有病变和健康部分。方法包括：将导管本体的能量输送部分定位在与待被加热的身体组织区域相邻的腔内；响应第一组织类型的热性质，确定脉冲特性；及从能量输送部分施加具有脉冲特性的脉动能量，从而在第二组织类型中积累热量的同时，通过按避免对于第一组织类型的显著热损害的速率，从第一组织类型中抽取热量，用疗法处理在身体组织区域内的第二组织类型。

Description

得知或未得知组织形态的选择性能量积累
对于相关申请的交叉参考
本申请在35 USC 119(c)下要求在2008年11月17日提交的美国临时申请No.61/115,344的权益；该临时申请的全部公开内容通过参引全部并入本文。
本申请涉及在2007年10月18日提交的、标题为“InducingDesirable Temperature Effects on Body Tissue”的美国申请No.11/975,474；在2007年10月18日提交的、并且标题为“System forInducing Desirable Temperature Effects on Body Tissue”的美国申请No.11/975,383；在2005年5月3日提交的、标题为“Imaging andEccentric Atherosclerotic Material Laser remodeling and/or AblationCatheter”的美国申请No.11/122,263；及在2008年9月22日提交的、标题为“Inducing Desirable Temperature Effects on Body TissueUsing Alternate Energy Sources”的美国临时申请No.61/099,155，这些申请的全部公开内容通过参引并入本文。
关于对在联邦主办研究和开发下进行的发明的权利的声明
不适用
技术领域
总体而言，本发明涉及用来加热身体组织的医疗器械、系统、及方法。在典型实施例中，本发明提供用来用能量加热身体组织的导管基治疗，能量在事前得知或未得知组织形态的情况下，选择性地积累在所期望类型的组织中，特别是在病变组织中。
背景技术
球囊血管成形术和其它导管常常用来打开由于动脉粥样硬化疾病已经变窄的动脉。与球囊膨胀(dilation)相关的损伤会造成显著的伤害，从而球囊膨胀的益处在时间方面受限制。支架通常用来扩展血管的有益打开。对于显著数量的病例，在放支架之后，体腔已经发生再狭窄或以后变窄。
最近，药物涂敷支架(如Johnson and Johnson的CypherTM支架，包括SirolimusTM的相关药物)已经显示出显著降低的再狭窄速率，并且其它人正在对可选择的药物洗脱支架进行开发和商业化。另外，也已经开始关于系统药物输送(静脉内或口服)的工作，这也可以改进程序血管成形术成功率。
尽管药物洗脱支架对于许多病人显示出为动脉粥样硬化的治疗提供了有意义的前景，但支架仍然存在着或者不能使用或者呈现显著缺点的许多情形。一般而言，放支架将植入物留在身体中。这样的植入物会呈现危险，包括机械疲劳、腐蚀等，特别是当植入物的除去困难并且涉及侵入式手术时。放支架对于治疗弥漫性动脉疾病、对于治疗分叉、对于治疗易压垮的身体区域、及对于治疗经受扭曲、延长、及缩短的动脉，存在着另外的缺点。
也已经提出各种改进的再狭窄治疗或再狭窄-阻止治疗形式，包括血管内辐射、冷冻治疗、超声波能量法等，常常与球囊血管成形术和/或放支架相结合。尽管这些和不同的手段对于减小在血管成形术和放支架之后血液流动的随后退化而言表现出不同程度的前景，但由血管成形术初始施加在组织上的损伤仍然是成问题的。
已经提出对于放支架和球囊血管成形术的多种替代方法，以便打开狭窄动脉。例如，已经提出和尝试各种各样的动脉粥样硬化斑切除器械和技术。尽管血管成形术和放支架存在着缺点和限制，但动脉粥样硬化斑切除术没有获得基于膨胀的手段的广泛使用和成功率。最近，膨胀的更进一步缺点已经显露。这些缺点包括易损斑块的存在，该易损斑块会破裂，并且释放可能引起心肌梗死或心脏病发作的材料。
鉴于上述，将会有利的是，提供用来在动脉组织中引起血管舒张和体腔重新塑造的方法和系统。进一步希望的是，在提供可重新塑造体腔的结构的同时避免显著成本或复杂性，而不必借助于极端扩张的损伤，并且允许不适于放支架的血管和其它体腔被打开。
发明内容
在第一方面，本发明的实施例提供一种用来加热与体腔相邻的身体组织区域的方法，该区域既具有第一组织类型又具有第二组织类型。所述方法包括：将导管本体的能量输送部分定位在与待被加热的身体组织区域相邻的腔内；响应第一组织类型的热性质，确定脉冲特性；以及从能量输送部分施加具有脉冲特性的脉动能量，从而在第二组织类型中积累热量的同时，通过按避免对于第一组织类型的显著热损害的速率，从第一组织类型中抽取热量，用疗法处理在身体组织区域内的第二组织类型。
在另一个方面，本发明的实施例提供一种用来加热与体腔相邻的身体组织区域的导管系统，该区域既具有第一组织类型又具有第二组织类型。所述系统包括：细长柔性导管本体，具有近侧端部和远侧端部，在近侧端部和远侧端部之间具有轴线；能量输送部分，靠近远侧端部；能量源，联接到能量输送部分上；及处理器，联接到能量源上，处理器构造用于控制从能量源到能量输送部分传输的脉动能量的脉冲特性，从而在第二组织类型中积累热量的同时，通过按避免对于第一组织类型的显著热损害的速率，从第一组织类型中抽取热量，用疗法处理在身体组织区域内的第二组织类型。
在多个实施例中，脉动能量优先地加热第二组织类型多于对第一组织类型的加热，优先加热至少部分地由第二组织类型的如下特性组的一种或多种引起：比第一组织类型的热传导低的热传导、比第一组织类型的比热低的比热、比第一组织类型的先天血液灌注少的先天血液灌注、及/或比在良好灌注区域与第一组织类型之间的距离大的远离良好灌注区域的距离。
在多个实施例中，特性组的大部分使得按避免对于第一组织类型的显著热损害的速率从第一组织类型中抽取热量，同时允许在第二组织类型中积累热量。
在多个实施例中，脉动能量按0.25至5瓦特的平均速率输送到身体组织区域。
在多个实施例中，脉动能量的每个脉冲在4至45焦尔之间提供给身体组织区域。
在多个实施例中，其中，输送到身体组织区域的脉动能量的平均速率，在通过第一组织类型的能量消散速率的约0.1与10.0倍之间。
在多个实施例中，在各脉冲之间的时间段允许第一组织类型适当地消散其热量，以避免由脉动能量对于第一组织类型的热损害。
在多个实施例中，在能量脉冲之间的时间段在0.1至180秒之间。
在多个实施例中，用于第一组织类型的热时间常数，是该给定组织的分立体积在经历指数衰减的同时失去其热量的63％将需要的近似时长。
在多个实施例中，脉动能量在至少几个第一组织类型时间常数的持续时间上输送到身体组织区域，其中，第一组织的热时间常数与第一组织类型的导热率成比例。
在多个实施例中，第二组织类型的导热率是第一组织类型的导热率的两倍。
在多个实施例中，能量源包括射频(RF)能量源。
在多个实施例中，能量输送部分包括可沿径向扩张的结构，该可沿径向扩张的结构接合抵靠体腔的多个电极表面，其中，抵靠体腔的多个电极表面完成多个回路，这些回路包括第一组织类型和第二组织类型，并且脉动能量被输送到多个回路。
在多个实施例中，能量源包括激光能量源。
在多个实施例中，能量输送部分包括至少一个沿径向定向的窗口，该沿径向定向的窗口联接到至少一个光导管上，该光导管在导管本体的近侧端部与至少一个窗口之间延伸，用于将脉动激光能量传输到身体组织区域。
在多个实施例中，能量源包括超声波发射器，该超声波发射器构造用于将脉动超声波能量输送到身体组织区域。
在多个实施例中，能量源包括微波能量源，该微波能量源包括至少一根微波天线，该微波天线构造用于将脉动微波能量输送到身体组织区域。
附图说明
图1示意地示出用来加热动脉组织的导管系统的一个实施例。
图2示出用在图1的导管系统中的球囊的一个实施例。
图3表示用来按热量或能量的恒定脉动速率加热健康组织和病变组织的温度相对于时间的分布。
图4表示对于组织的温度相对于时间的分布，该组织具有健康组织和病变组织，其中，热量或能量按不同速率施加。
图5表示相对于温度的热量消散影响。
图6示意地示出为在腿部中的组织的双极治疗使用的球囊导管系统的一个实施例。
图7示意地示出为在腿部中的组织的单极治疗使用的球囊导管系统的一个实施例。
图8A-8C示出使用治疗动脉组织的球囊导管系统的方法。
具体实施方式
已经开发了多种疗法，以替换或改进传统的球囊血管成形术和支架。在本发明的背景技术部分中描述的器械的多种或者切割、烧蚀、或气化在动脉中的病变组织。例如，激光器械气化斑块，并且将它冲洗到下游。动脉粥样硬化斑切除器械切去斑块，并且将它吸到体外。切割球囊切入动脉壁，对组织造成损害。
有利的是，提供不切割、烧蚀、或气化的系统和器械。三种治疗形式避免这些缺陷，它们包括：冷却组织；非烧蚀形式的直接分子变性；及非烧蚀性加热。冷却已经使用诸如Boston Scientific’s Cryo-cath之类的器械实施。直接分子变性可借助于辐射-诸如伽马射线-而实现。本发明涉及最后一种形式——非烧蚀性加热。
本发明的一些实施例一般提供下面更详细论述的器械、系统、及方法，这些器械、系统、及方法在知道或不知道组织形态的情况下，使用在动脉组织中能量的选择性积累，来加热具有疾病部分的动脉组织。本发明对于下述用途特别有用：沿部分闭塞动脉重新塑造材料，以便打开动脉腔和增大血液流动。这里公开的器械、系统、及方法可以用在任何动脉中，例如用在股动脉、腘动脉、冠状动脉、及/或颈动脉中。用来加热动脉组织的器械已经公开在共同待决美国专利申请No.11/975,474、No.11/975,383、No.11/122,263及美国临时申请No.61/099,155中，这些申请的全部公开内容通过参引并入本文。
尽管本发明将技术使用的焦点集中在脉管系统中，但该技术对于任何腔道阻塞也是有用的。本发明可以用在其中的其它解剖结构是食管、口腔、鼻腔、咽鼓管和鼓室、脑窦、动脉系统、静脉系统、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、及子宫颈。
系统的一些实施例将能够通过柔和加热与动脉的扩张相结合处理组织。脉管壁的加热可以在借助于球囊的扩张之前、期间、及/或之后进行，具有处于标准、未加热血管成形术扩张压力的或比其显著低的扩张压力。例如，在10-16个大气压的球囊充胀压力对于特定损伤的标准血管成形术扩张可能是适当的场合，这里描述的与柔和加热相结合的改进扩张治疗可以采用10-16个大气压，或者可以借助于6个大气压或更低的大气压而实现，并且有可能低到1至2个大气压。在动脉斑块发生钙化的情况下，可能更难以重新塑造和打开疾病动脉，所以导管可以使用标准血管成形术球囊与超声波能量相结合，以打碎钙并且重新塑造和打开腔道。
在血管的扩张之前、期间、及/或之后添加的柔和加热能量可以增加扩展有效性，同时降低复杂性。在一些实施例中，借助于球囊扩张的这样的受控加热可以呈现弹回的减少，提供支架状膨胀的各种益处的至少一些，而没有植入物的缺点。柔和加热的益处可以通过将外膜层的加热限制到有害响应阈值以下而得以增强(并且/或者阻止复杂性)。在多种情况下，内膜和/或中膜的这样的加热可以使用小于约10秒，常常小于3(或甚至2)秒，的加热时间而提供。在其它情况下，非常低的功率可以使用较长持续时间。
身体组织的加热涉及能量的施加，该能量呈射频(RF)、微波及/或超声波能量等的形式。这种能量将被控制，以便限制身体组织的温度。在一些实施例中，身体组织温度范围依据施加的能量和组织类型，从约50℃至约90℃。
尽管这里描述的方法和器械在血管的组织处理方面不是选择性的，但器械可用于同心和偏心动脉粥样硬化两者的处理。这种非选择性处理特别有利，因为动脉粥样硬化相对于血管轴线超过50％的时间可能是偏心的，有可能高达病例的75％(或甚至更多)。
尽管本发明可以与放支架相结合地使用，但本发明特别良好地适于增大血管的敞开直径，在这些血管中放支架不是可行的选项。潜在用途包括弥漫性疾病的治疗，在该弥漫性疾病中，动脉粥样硬化沿动脉的可观长度扩展，而不是局限在一个区域中。本发明也对于曲折、急弯脉管的处理获得有利使用，因为不必将支架行进到多个血管的急弯中或者在其内扩张。更进一步有利的应用包括沿分叉(在该处，侧支堵塞可能是问题)和在诸如腿、脚、及臂之类的边缘末端(在该处，压碎和/或支架破裂失效可能是成问题的)中的处理。
所公开的系统至少包括能量源和导管，该导管具有能量输送部分，该能量输送部分构造成用来加热与体腔相邻的身体组织区域，区域既具有第一组织类型，如健康组织，又具有第二组织类型，如病变组织。导管可以与当今通常用来治疗动脉疾病的球囊导管相似，不同之处在于添加了用于加热的电极。其它实施例可以使用：换能器，布置在球囊上，以将超声波加热施加到脉管壁上；或微波天线，布置在球囊上，以将微波加热施加到脉管壁上。能量源可以联接到处理器，以控制从能量源到能量输送部分传输的脉动能量的脉冲特性，从而用疗法处理在身体治疗区域内的组织，而不引起对于身体治疗区域的显著热损害，从而产生长期留藏响应(occlusive response)。
在使用中，导管本体的能量输送部分定位在与待被加热的身体组织区域相邻的腔内。响应第一组织类型的热性质确定脉冲特性，并且从能量输送部分施加具有脉冲特性的脉动能量，从而用疗法处理身体组织区域。
图1表示用来加热动脉组织的导管系统10的一个实施例。导管系统10包括球囊导管12，该球囊导管12具有导管本体14，该导管本体14具有近侧端部16和远侧端部18。导管本体14是柔性的，并且限定导管轴线15，并且可以包括一个或多个孔腔，如导丝孔腔22和充胀孔腔24(见图2)。如果对于其它治疗或用途是希望的，如对于灌注、流体输送、成像等，则可以提供更多的孔腔。导管12包括与远侧端部18相邻的可充胀球囊20、和与近侧端部16相邻的外壳29。外壳29包括与导丝孔腔22连通的第一连接器26、和与充胀孔腔24连通的第二连接器28。充胀孔腔24在球囊20与第二连接器28之间延伸。第一和第二连接器26、28都可以选择性地包括标准连接器，如Luer-LocTM连接器。远侧末端可以包括整体末端阀，以允许导丝等的通过。
外壳29也容纳电气连接器38。连接器38包括多个电气连接件，每个经导体36电气联接到电极34上。这允许电极34容易被激励，电极常常由控制器40和能量源42激励，如由双极或单极RF能、微波能、超声波能、或其它适当能量源激励。在一个实施例中，电气连接器38经控制器40联接到RF发生器上，使控制器40允许能量选择性地导向电极38。当采用单极RF能量时，病人接地可以(例如)由外部电极或在导管本体14上的电极提供。
在一些实施例中，控制器40可以包括处理器，或者联接到处理器上，以对治疗加以控制或记录。处理器将典型地包括计算机硬件和/或软件，常常包括一个或多个可编程处理器单元，该可编程处理器单元运行机器可读程序指令或代码，该机器可读程序指令或代码用来实施这里描述的方法的一种或多种的一些或全部。代码将常常嵌在有形介质中，如嵌在存储器(选择性地只读存储器、随机存取存储器、非易失存储器等)和/或记录介质(如软盘、硬盘、CD、DVD、非易失固状存储卡等)中。代码和/或相关数据和信号也可以经网络连接(如无线网络、以太网、互联网、内部网络等)传输到处理器或从处理器传输，并且代码的一些或全部也可以在导管系统10的各元件之间和在处理器内经一根或多根总线传输，并且适当标准或专有通信卡、连接器、电缆等将常常包括在处理器中。处理器将常常构造成，至少部分地通过用软件代码编程处理器完成这里描述的计算和信号传输步骤，该软件代码可以写成单个程序、一系列分离的子例行程序或相关程序等。处理器可以包括标准或专有数字和/或模拟信号处理硬件、软件、及/或固件，并且将典型地具有足够的处理能力，以在病人的治疗期间完成这里描述的计算，处理器选择性地包括个人计算机、笔记本电脑、图形板计算机、专有处理单元、或其组合。也可以包括与现代计算机系统相关的标准或专有输入装置(如鼠标、键盘、触摸屏、操纵杆、等等)和输出装置(如打印机、扬声器、显示器、等等)，并且具有多个处理单元(或甚至分离计算机)的处理器可以用在宽广范围的集中的或分布的数据处理体系结构中。
在图2中示出更详细地球囊20。球囊20一般包括联接到充胀孔腔24上的近侧部分30、和联接到导丝孔腔22上的远侧部分32。球囊20当用流体或气体充胀时，沿径向扩张。在一些实施例中，流体或气体可以是非传导性的，并且/被冷却。在一些实施例中，球囊20可以是被加压以接触动脉组织的低压球囊。在其它实施例中，球囊20是血管成形术球囊，该血管成形术球囊能够具有既加热动脉组织又使动脉腔扩张的较高压力。球囊20可以包括柔顺或非柔顺球囊，该柔顺或非柔顺球囊具有螺旋折叠，以促进将球囊从径向扩张、充胀构造重新构造到小截面构造，特别是为了在使用后被除去。
电极34安装在球囊20的表面上，使相关导体36从电极向近侧延伸。电极34可以按多种不同图案或阵列布置在球囊20上。系统可以用于单极或双极能量施加。对于单极能量的输送，或者在导管轴上、或者在病人皮肤上使用接地电极，例如使用接地电极垫。对于双极能量的输送，相邻电极轴向偏移，以允许双极能量被导向在相邻的圆周(沿轴向错开的)电极之间。在其它实施例中，电极可以布置在绕球囊的带条中，以允许双极能量被导向在相邻的远侧和近侧电极之间。在一些实施例中，电极34可以定位在球囊20的内部。电极34可以按多种不同的图案或阵列布置在球囊20上。如以前提到的那样，其它实施例可以包括超声波换能器或微波天线，该超声波换能器或微波天线安装在球囊20的表面上。
这里公开的实施例在知道或不知道组织形状的情况下围绕在动脉组织中能量的选择性积累的概念而布置。这通过利用在健康组织与病变组织之间的组织性质差别而完成。具有不同性质的组织的优先加热可在不知道不同组织的位置或类型的情况下完成。如果第一组织类型具有比第二组织类型好的导热率(k)，则它将更迅速地传导走热量。如果第二组织类型具有比第一组织类型低的比热(cp)，则给定施加到相同质量(和体积，假定比较相似的组织密度)上的相同量的能量，其温度将升高得更多。如果第一组织类型具有较致密的脉管系统，或者可靠地较靠近良好灌注区域，则它将比第二组织类型更迅速地传导走热量。
本发明允许具有如下特性的一种或多种的组织类型的优先加热：
●较差(低)热传导，
●较低比热，
●较少先天血液灌注，及/或
●离良好灌注区域的比较大距离。
在病变组织的情况下，以上特性的全部适用。疾病一般包括脂肪状病变组织和/或纤维胶原状组织。这些组织的两者都具有比健康血管组织-特别是中膜(media)，低的比热和低的导热率。健康血管组织也具有更微小的脉管系统，并且更靠近良好灌注组织，因此健康组织可更有效地消耗掉热量，而没有像交通堵塞那样的热流“逆行”。
利用组织性质的这种差异的关键在于如下：热量按与涉及的组织的热时间常数成比例的速率施加或产生在组织内，可能使用脉冲宽度调制(PWM)手段。在每个“脉冲”期间，相同量的能量输送或产生，而与组织类型无关。组织形态可以是未知的，因此相同的“治疗”施加到每一处。然而，在病变组织中的各处的温度分布将较高，因为它具有较低比热。病变组织也将保持其热量较长，因为它具有较低导热率并因此具有较长热时间常数。因而，健康组织将热得较慢且冷得较快，这对于这种具体用途正是希望的。目标是加热病变组织，而不加热健康组织。在脉冲之间的时间量然后可修整，以允许健康组织适当地冷却和消散其热量，从而不超过对于健康组织造成热损害的特定量。
图3表示用来按热量或能量的恒定脉动速率加热健康组织110和病变组织120的温度相对于时间的分布。病变组织的温度将比健康组织升得较快且冷得慢，因此比健康组织更有效地积累热量和接受治疗。
图4表示对于组织的温度相对于时间的分布，该组织具有健康组织和病变组织，其中，热量或能量按不同速率施加。该图表示可以初始较快地施加或产生热量(在治疗的开始处)，以便更迅速地斜升组织温度。这可借助于功率调制或具有可变脉冲宽度的PWM进行。这样的目的是，迅速加热组织并且然后允许健康组织在各脉冲之间消散热量，这将减少实现(和可能地吸收)一定温度需要的总处理时间。
时间常数：
t = RC = ( l n k ) ( mc p ) , 其中健康的t≈7s，并且病变的t≈14s。
比热：
中膜cp≈3.9
外膜cp≈3.1
脂肪cp≈2.4
导热率：
中膜k≈.59
外膜k≈.49
脂肪k≈.20
以上的“时间常数”是热时间常数。该常数是该给定组织的分立体积在其热量(和因此温度)经历指数衰减的同时失去63％需要的近似时长。热时间常数与导热率成正比。因此，因为在脂肪病变组织和健康中膜组织的导热率之间近似有2∶1的比率，所以在它们的时间常数之间也有2∶1的比率。
基于32mm3的治疗体积、0.5W/m/K的导热率、32mm2的热前部横截面面积、及3.6J/g/K的比热，估计对于健康中膜组织的热时间常数是7秒。在这种情况下，人们想在至少几倍常数的持续时间上，例如35秒、70秒、等等，输送适当治疗剂量的能量。
图5表示关于温度对时间的热量消散效果。因为热消散将根据指数衰减而发生，所以冷却速率将相对于时间非线性地变化。所以，必须与功率和工作循环一道适当地选择周期。功率和比热——忽略热量消散，将确定在加热期间温度升高的速率。功率、工作循环、比热、及连续热量消散的速率，将确定温度变化的平均速率。病变组织210和健康组织220在没有热量消散的情况下，都具有比在有热量消散的情况下的病变组织215和健康组织225高的平均温度。
关于图5要注意的重要事情是，平均功率(按时间的平均能量)必须足够低，从而热量消散速率在比较中是有效的。换句话说，如果我们假定一定几何形状的健康血管可按2焦尔每秒(2瓦特)的速度有效地消散能量，那么能量施加的平均速率也需要在这个数量级上，以便使效果显著。
这是本发明的主要难点-按与涉及的热时间常数成比例的平均速率施加能量，从而在组织热性质之间的显著差别可被利用以实现我们的优点。
图6示意地示出借助于系统10的双极组织处理。具有电极对34A和34B的球囊20定位在动脉腔中，该动脉腔具有脂肪疾病/坏死芯48、纤维疾病/纤维帽44、健康组织45。由在电极对34A和34B之间的脉动能量对健康组织45和脂肪疾病/坏死芯48、纤维疾病/纤维帽44进行处理。电极对可以是在球囊上的任何电极对，例如，在一些实施例中，电极对可以是34A和34C、或34A和34D、或对于34A-34D中的任何组合。这种布置形成了穿过组织的能量路径50，该能量路径50将能量或热量(“组织重新塑造能量”)输送到在电极对之间的动脉组织(“重新塑造区”)。通过使用重叠对，使用电极对的不同组合可以减小或消除在重新塑造区之间的间隙。使用具有双极能量的电极对可以避免单极方式的某些潜在问题。病变动脉48具有比健康动脉组织45高的电阻。通过使用在双极系统中的电极对34A、34B，能量路径50将穿过在电极对之间的健康组织、病变组织、或健康和病变组织两者的组合。任何数量的电极对可以按不同图案或阵列使用。
图7示意地示出借助于系统10的双极组织处理。具有电极对34A和34B的球囊20定位在动脉腔中，该动脉腔具有脂肪疾病/坏死芯48、纤维疾病/纤维帽44、健康组织45，并且使用一个或多个电气接地(未示出)，如定位在病人皮肤上。当电力施加到绕动脉腔的圆周布置的多个单极电极34上时，能量54径向向外穿过动脉壁导向，并且处理病变的和健康的动脉组织两者。
用来通过脉动能量处理组织的导管系统10的使用可参照图8A-8C理解。如在图8A中看到的那样，对于处理部位的接近将常常涉及使导丝56在病变组织48的目标区域处的血管58内前进。可以由不透射线标记、或由不透射线结构(或放置在球囊20上或其附近的对应不透射线标记)、及/或通过不透射线电极34的使用而促进对球囊20的定位。导丝56可以在荧光(或其它)成像下定位。
导管12在导丝56上向远侧前进，并且定位成与动脉粥样硬化材料48相邻。球囊20在血管腔内沿径向扩张，从而电极34、或电极34A或34B沿径向接合动脉组织。由于病变组织48可能绕导管12偏心地分布，所以电极34可能接合病变组织48、健康组织60、或两种组织的组合。
如以上论述的那样，各电极34沿周向围绕球囊20定位。脉动能量被引导到电极34、或相邻电极对34A和34B，处理病变组织48和健康组织60两者。控制器40可以提供脉动能量，以便按约0.25至5瓦特平均功率将电极激励0.1至180秒，或者按约4至45焦尔。功率和持续时间被校准成比足以引起严重损害的量要小，并且特别是比足以烧蚀在血管内的组织要小。
现在参照图8C，如以上描述的那样，球囊20可以是血管成形术球囊，该血管成形术球囊将加热与打开动脉腔相组合，从而热量优先输送到病变组织48，例如以便适中地加热帽结构(引起帽的加厚并且使斑块较不易破裂)并且/或者加热易损斑块的富脂池(从而重新塑造、变性、熔化、收缩、及/或重新分布富脂池)，而健康组织60消散热量而不受损害。
在一些实施例中，球囊20可以重复地收缩，导管12的轴向运动用来重新定位球囊20，使球囊20随后在沿病变组织的多个处理位置的每一个处发生扩张。
尽管本文总体上参照脉管系统进行了描述，但本文描述的导管器械、系统、及方法也可以用在具有组织类型的人类解剖学的其它脉管的腔道中，该组织类型具有不同的性质，如以上论述的那样。导管可以放置在其中的解剖结构是例如食管、口腔、鼻腔、咽鼓管和鼓室、脑窦、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、及子宫颈、以及动脉系统、静脉系统、及/或心脏。
尽管为了清楚理解的目的，已经以例示方式对于一些细节描述了一些例示性实施例，但本领域的技术人员将认识到，可以采用各种改进、修改、及变更。因此，本发明的范围应该仅由权利要求书限定。

Claims (35)

1.一种用来加热与体腔相邻的身体组织区域的方法，所述区域既具有第一组织类型又具有第二组织类型，所述方法包括：
将导管的能量输送部分定位在与待被加热的身体组织区域相邻的腔内；
响应所述第一组织类型的热性质，确定脉冲特性；及
从所述能量输送部分施加具有所述脉冲特性的脉动能量，从而在所述第二组织类型中积累热量的同时，通过按避免对于所述第一组织类型的显著热损害的速率，从所述第一组织类型中抽取热量，用疗法处理在所述身体组织区域内的所述第二组织类型。
2.根据权利要求1所述的方法，其中，所述脉动能量优先地加热所述第二组织类型多于对所述第一组织类型的加热，所述优先加热至少部分地由所述第二组织类型的如下特性组的一种或多种引起：比所述第一组织类型的热传导低的热传导、比所述第一组织类型的比热低的比热、比所述第一组织类型的先天血液灌注少的先天血液灌注、及/或比在良好灌注区域与所述第一组织类型之间的距离大的远离良好灌注区域的距离。
3.根据权利要求2所述的方法，其中，所述特性组的大部分使得按避免对于所述第一组织类型的显著热损害的速率从所述第一组织类型中抽取热量，同时允许在所述第二组织类型中积累热量。
4.根据权利要求1所述的方法，其中，所述脉动能量按0.25至5瓦特的平均速率输送到所述身体组织区域。
5.根据权利要求1所述的方法，其中，所述脉动能量的每个脉冲在4至45焦尔之间提供给所述身体组织区域。
6.根据权利要求1所述的方法，其中，输送到所述身体组织区域的脉动能量的平均速率，是在通过所述第一组织类型的能量消散速率的约0.1与10.0倍之间。
7.根据权利要求1所述的方法，其中，在脉冲之间的时间段允许所述第一组织类型适当地消散其热量，以避免由所述脉动能量对于所述第一组织类型的热损害。
8.根据权利要求1所述的方法，其中，在能量脉冲之间的所述时间段在0.1至180秒之间。
9.根据权利要求1所述的方法，其中，用于所述第一组织类型的热时间常数，是该给定组织的分立体积在经历指数衰减的同时失去其热量的63％将需要的近似时长。
10.根据权利要求1所述的方法，其中，所述脉动能量在至少几个第一组织类型时间常数的持续时间上输送到所述身体组织区域，其中，所述第一组织的热时间常数与所述第一组织类型的导热率成比例。
11.根据权利要求10所述的方法，其中，所述热时间常数与所述第一组织类型的导热率成比例。
12.根据权利要求11所述的方法，其中，所述第二组织类型的导热率是所述第一组织类型的导热率的两倍。
13.根据权利要求1所述的方法，其中，能量源包括射频(RF)能量源。
14.根据权利要求13所述的方法，其中，能量输送部分包括可沿径向扩张的结构，该可沿径向扩张的结构接合抵靠所述体腔的多个电极表面，其中，抵靠所述体腔的所述多个电极表面完成多个回路，这些回路包括第一组织类型和第二组织类型，并且脉动能量被输送到所述多个回路。
15.根据权利要求1所述的方法，其中，所述能量源包括激光能量源。
16.根据权利要求15所述的方法，其中，所述能量输送部分包括至少一个沿径向定向的窗口，该沿径向定向的窗口联接到至少一个光导管上，该光导管在所述导管本体的近侧端部与所述至少一个窗口之间延伸，用于将脉动激光能量传输到所述身体组织区域。
17.根据权利要求1所述的方法，其中，能量源包括超声波发射器，该超声波发射器构造用于将脉动超声波能量输送到所述身体组织区域。
18.根据权利要求1所述的方法，其中，能量源包括微波能量源，该微波能量源包括至少一根微波天线，该微波天线构造用于将脉动微波能量输送到所述身体组织区域。
19.一种用来加热与体腔相邻的身体组织区域的导管系统，所述区域既具有第一组织类型又具有第二组织类型，所述系统包括：
细长柔性导管本体，其具有近侧端部和远侧端部，在近侧端部和远侧端部之间具有轴线；
能量输送部分，其靠近所述远侧端部；
能量源，其联接到所述能量输送部分上；及
处理器，其联接到所述能量源上，所述处理器构造用于控制从所述能量源传输到所述能量输送部分的脉动能量的脉冲特性，从而在所述第二组织类型中积累热量的同时，通过按避免对于所述第一组织类型的显著热损害的速率，从所述第一组织类型中抽取热量，用疗法处理在所述身体组织区域内的所述第二组织类型。
20.根据权利要求19所述的系统，其中，所述脉动能量优先地加热所述第二组织类型多于对所述第一组织类型的加热，所述优先加热至少部分地由所述第二组织类型的如下特性组的一种或多种引起：比所述第一组织类型的热传导低的热传导、比所述第一组织类型的比热低的比热、比所述第一组织类型的先天血液灌注少的先天血液灌注、及/或比在良好灌注区域与所述第一组织类型之间的距离大的远离良好灌注区域的距离。
21.根据权利要求20所述的系统，其中，所述特性组的大部分使得按避免对于所述第一组织类型的显著热损害的速率从所述第一组织类型中抽取热量，同时允许在所述第二组织类型中积累热量。
22.根据权利要求19所述的系统，其中，所述脉动能量按0.25至5瓦特的平均速率输送到所述身体组织区域。
23.根据权利要求19所述的系统，其中，所述脉动能量的每个脉冲在4至45焦尔之间提供给所述身体组织区域。
24.根据权利要求19所述的系统，其中，输送到所述身体组织区域的脉动能量的平均速率，在通过所述第一组织类型的能量消散速率的约0.1与10.0倍之间。
25.根据权利要求19所述的系统，其中，在脉冲之间的时间段允许所述第一组织类型适当地消散其热量，以避免由所述脉动能量对于所述第一组织类型的热损害。
26.根据权利要求19所述的系统，其中，在脉动能量的脉冲之间的时间段在0.1至180秒之间。
27.根据权利要求19所述的系统，其中，用于所述第一组织类型的热时间常数，是该给定组织的分立体积在经历指数衰减的同时失去其热量的63％将需要的近似时长。
28.根据权利要求19所述的系统，其中，所述脉动能量在至少几个第一组织类型时间常数的持续时间上输送到所述身体组织区域，其中，所述第一组织的热时间常数与所述第一组织类型的导热率成比例。
29.根据权利要求28所述的系统，其中，所述第二组织类型的导热率是所述第一组织类型的导热率的两倍。
30.根据权利要求25所述的系统，其中，所述能量源包括射频(RF)能量源。
31.根据权利要求30所述的方法，其中，所述能量输送部分包括可沿径向扩张的结构，该可沿径向扩张的结构接合抵靠所述体腔的多个电极表面，其中，抵靠所述体腔的所述多个电极表面完成多个回路，这些回路包括第一组织类型和第二组织类型，并且脉动能量被输送到所述多个回路。
32.根据权利要求19所述的系统，其中，所述能量源包括激光能量源。
33.根据权利要求32所述的系统，其中，所述能量输送部分包括至少一个沿径向定向的窗口，该沿径向定向的窗口联接到至少一个光导管上，该光导管在所述导管本体的近侧端部与所述至少一个窗口之间延伸，用于将脉动激光能量传输到所述身体组织区域。
34.根据权利要求19所述的方法，其中，所述能量源包括超声波发射器，该超声波发射器构造用于将脉动超声波能量输送到所述身体组织区域。
35.根据权利要求19所述的方法，其中，所述能量源包括微波能量源，该微波能量源包括至少一根微波天线，该微波天线构造用于将脉动微波能量输送到所述身体组织区域。
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CN111629682A (zh) * 2018-01-10 2020-09-04 美敦力公司 定向聚焦的消融设备
CN112168474A (zh) * 2020-10-30 2021-01-05 广州市中崎商业机器股份有限公司 一种具有诊断功能的电子降温仪及其控制方法
CN112168474B (zh) * 2020-10-30 2022-07-05 广州市中崎商业机器股份有限公司 一种具有诊断功能的电子降温仪

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AU2009314133B2 (en) 2015-12-10
AU2016201555A1 (en) 2016-03-31
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EP2355737A1 (en) 2011-08-17
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