CN102125430A - 选择性地治疗目标组织的内腔电组织表征和调谐射频能量 - Google Patents
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Abstract
一种导管和导管系统可以使用被专门设计来用于重塑和/或去除沿着身体内腔的目标物质的能量，所述物质经常是病人的血管的动脉粥样硬化物质。具有径向可扩展的结构的细长柔性导管体可以具有多个电极或者其他电外科能量提供表面，以当所述结构扩展时径向接合动脉粥样硬化物质。动脉粥样硬化物质检测器系统可选地使用阻抗监控来测量和/或表征动脉粥样硬化物质及其位置。
Description
本申请是申请日为2006年3月28日、申请号为200680016424.0、发明名称为“用于选择性地治疗动脉粥样硬化和其他目标组织的内腔电组织表征和调谐射频能量”的中国专利申请的分案申请。
相关申请的交叉引用
本申请要求2005年3月28日提交的、名称为“动脉粥样硬化和其他目标组织和/或结构的选择性治疗的调谐射频能量”的美国临时申请第60/666,766号的优先权的权益，并且与2004年9月10日提交的、名称为“动脉粥样硬化物质的可选择的偏心重塑和/或消融”的美国专利申请第10/938,138号相关联，这些申请的全部公开内容通过引用被包含在此。
技术领域
本发明总地涉及医疗装置、系统和方法。在示例实施例中，本发明向内腔疾病(luminal disease)，特别是动脉粥样硬化斑块(plaque)和易损或者“热”斑块等提供了基于导管(catheter)的诊断和/或治疗。本发明的结构允许进行受引导的偏心(eccontric)动脉粥样硬化物质分析、重塑和/或去除，经常使用电气诊断信号和电外科能量这两者。
背景技术
医生使用导管来访问和修复身体的内部组织，特别是在诸如血管之类的身体内腔内的内部组织。例如，经常使用球囊血管成形术(balloon angioplasty)和其他导管来打开由于动脉粥样硬化疾病而变窄的动脉。
球囊血管成形术在打开闭塞的血管时经常是有效的，但是与球囊扩张(dilation)相关联的创伤会带来很大的损伤，因此球囊扩张的益处可能在时间上受限。通常使用支架(stent)来延长血管的有益打开。
与球囊扩张相结合建立支架经常是对于动脉粥样硬化的优选治疗。在建立支架时，在向身体中引入的球囊导管上安装折叠(collapsed)的金属框架。支架被操作到阻塞的位置，并且通过下部的球囊的扩张而原地扩展。支架已经获得了广泛的接受，并且在许多情况下产生一般可接受的结果。伴随着血管(特别是冠状动脉)的治疗，支架也可以用于治疗身体内的许多其他的管道堵塞，诸如用于治疗再生的、肠胃的和肺的堵塞。
在大量的情况下，在建立支架后发生身体内腔的再狭窄(restnosis)或者随后的变窄。最近，涂有药的支架(诸如Johnson和Johnson的CypherTM支架、相关联的药包含SirolimusTM)已经显示出显著降低的再狭窄率，并且其他人正在开发和商业化替代的药物洗脱支架。另外，也已经启动了全身性药物提供(静脉内的或者口服的)的工作，其也可以改善程序上的血管成形术成功率。
虽然药物洗脱支架在许多病人身上看起来提供了治疗动脉粥样硬化的很大希望，但是仍然存在支架不能被使用或者显示出较大缺点的许多情况。一般，建立支架在身体中留下植入体内的物体。这样的植入体内的物体带来风险，包括机械疲劳或者腐蚀等，特别是当植入体内的物体的取出困难并且涉及侵入性的手术时。建立支架可能在治疗扩散的动脉疾病、治疗双叉、治疗易于受到挤压影响的身体区域和用于治疗被扭转、延长和缩短的动脉方面具有另外的缺点。
多种修改的再狭窄治疗或者防止再狭窄的堵塞治疗形态也已经被提出，包括血管内的辐射、低温治疗和超声波治疗等，它们经常与球囊血管成形和/或建立支架相组合。虽然这些不同的手段带来了降低在球囊血管成形和建立支架后在血流中的随后变差的不同程度的希望，但是由血管成形初始施加在组织上的创伤仍然是问题。
也已经提出了对于建立支架和球囊血管成形的多种替代，以便打 开变狭窄的动脉。例如，已经公开和尝试了多种动脉粥样硬化切除装置和技术。虽然血管成形和建立支架存在缺点和限制，但是动脉粥样硬化切除术还没有获得广泛的使用和基于扩张的手段的成功率。近来，扩张的其他缺点已经显现。这些缺点包括存在易损(vulnerable)的斑块，其会破裂和释放可能引起心肌梗塞形成或者心脏病发作的物质。
根据上述内容，提供用于诊断、表征、重塑和/或去除动脉粥样硬化物质和身体内腔(特别是血管)的阻塞的新的装置、系统和方法是有益的。在提供下述结构的同时，进一步期望避免大成本和复杂性：所述结构可以表征和重塑或者去除斑块和其他阻塞物质而不会有扩张的创伤，并且进一步期望允许打开不适合于建立支架的血管和其他身体内腔。如果诊断和治疗系统可以提供关于治疗的进展的反馈，则也是有益的。
发明内容
本发明总地来说提供用于治疗身体内腔的疾病的改进的装置、系统和方法。本发明的实施例允许分析和/或治疗沿这些身体内腔的物质，可选地允许使用可变频率电功率或者信号源来表征斑块和其他病变。通过在(例如)血管内径向扩展支撑电极阵列的篮(basket)，并且通过监控利用所述阵列的所选择的电极形成的电路的电气特征(具体地是频率、阻抗相角和阻抗数值)，可以局部分析沿着血管的斑块、纤维状的易损或者“热”斑块、健康组织、经治疗的组织等等。可选地，可以使用相同的电极来按照所述分析的结果而选择性地(并且经常是偏心地)治疗这些组织。
本发明的实施例可以使用电能来选择性地加热目标组织和/或其他结构。例如，可以专门设计(tailor)电能波形、施加周期、电势和提供(delivery)系统等以帮助在禁止对于旁边的组织结构的伤害的同时将治疗能量引导到脉管系统的动脉粥样硬化和其他疾病组织。因为至少一些有疾病的组织的电气特征(特别是它们相对于周围组织的 阻抗的阻抗)可能趋向于将已知的电外科治疗能量推动到健康的相邻组织，因此这样的专门设计可以改善内腔治疗的功效，并且/或者减少对旁边组织的伤害。用于物理目标定位(targeting)(例如从血管内轴向和/或径向地对阻塞组织进行目标定位)和/或频率目标定位的示例治疗系统和方法可以使用疾病定位(locatization)信息(例如通过血管内成像或阻抗测量等)，并且可选地使用冷却来保护沿着内腔壁的至少一些组织。
在第一方面，本发明提供了一种导管系统，用于重塑和/或减少病人的身体内腔的物质或者与所述身体内腔相邻的物质。所述系统包括细长的柔性导管体，其具有近端和远端，其间有轴。在远端附近布置了至少一个能量提供(delivery)表面。电源电耦合到所述能量提供表面。所述电源以帮助能量加热所述物质并且禁止旁边组织伤害的电能形式来对于所述能量提供表面供电。
在另一个方面，本发明提供了一种用于分析血管的管壁的方法。所述方法包括：将所述管壁与探针的电极接合，并且使用可变频率的电源来对于所述电极供电。电源的频率可以改变，并且通过监控电路的频率相关特性来表征所述管壁的目标斑块。所述电路包括所述电源、所述电极和所述被接合的管壁。
可选地，所述探针在血管内径向扩展，以便将多个电极接合到管壁。被扩展的探针的所述多个电极总体上限定了周向分布的电极阵列，并且所述阵列的电极可以被所述探针的相关联的支柱(struct)支撑。所述支柱可以在所述血管内有弹性地和独立地扩展，以便将所述阵列耦合到非圆形的内腔内的管壁。与目标斑块相邻的所述阵列的偏心子集(可选地，单个电极或者相邻的一对电极)可以被供电以局部地表征组织，并且/或者使用重塑电势来偏心地重塑所表征的目标斑块。重塑的反馈可以通过下述方式被获得：通过在重塑期间或者通过至少暂时地中止重塑，在施加适当的可变频率信号的同时监控电路的特征。
在示例实施例中，所表征的目标斑块可以包括易损的斑块，并且 可以响应于电路的电气特征来中止重塑。例如，可以响应于组织特征(signature)信号(诸如在所选择的频率或者频率范围的阻抗相角和数值)的改变而中止重塑，特别是当所述改变与易损斑块的脂类加热到摄氏85度或者更高温度相关联时。更一般而言，可以使用组织特征和/或组织特征简档(profile)来表征目标斑块，所述特征简档包括曲线或者多组数据，其表示在一个频率范围内的不同频率的多个组织特征测量值。通过将测量的组织特征简档与至少一个其他的组织特征简档相比较来表征所述目标斑块，并且可以允许识别该测量的特征简档与健康组织、钙化斑块或者易损斑块中的至少一个相关联，示例实施例能够识别它们中的至少两个。有益的实施例可以通过下述方式允许在所述斑块和还没有治疗的、已经部分治疗的和已经被适当地治疗的其他组织之间进行区分：可选地，通过查看特征简档的组织特征测量值的子集的改变(例如在适当的频率等)。
许多实施例将适合于表征轴向和/或围绕血管偏心地分布的多个局部物质，并且可选地适合于使用电极通过不同的重塑治疗而选择性地处理不同的所表征的物质。所述组织特征简档可以相对于病人的已知组织(诸如使用血管内的超声波或者其他已知技术而识别的健康组织)而被归一化和/或基准化，并且可以使用组织特征简档的相对斜率或者在组织特征简档之间的偏差(最好是两者)来表征目标斑块。所述简档的频率范围经常在50KHz之下延伸，通常是从在大约50KHz之下延伸到超过1MHz，并且在一些实施例中，从大约4Hz延伸到大约2MHz。
在另一个方面，本发明提供了一种用于分析血管的管壁的系统。所述系统包括血管探针，其具有近端、远端和电极，所述电极被布置在所述远端附近，用于接合管壁。可变频率电源可以耦合到所述电极，以便当所述电极接合所述管壁时，可以建立电路(包括电源、电极和被接合的管壁)。处理器与所述可变频率电源耦合，所述处理器被配置来通过监控所述电路的频率相关特性而表征管壁的目标斑块。
附图说明
图1A图解了扩散动脉粥样硬化疾病，其中，多个血管的实质长度具有有限的有效直径。
图1B图解了血管内的易损斑块。
图1C图解了一些血管的锐弯或者弯曲。
图1D图解了在分叉处的动脉粥样硬化疾病。
图1E图解了与四肢的动脉粥样硬化疾病相关联的病变。
图1F是支架破裂或者腐蚀的图示。
图1G图解了血管内的剥离(dissection)。
图1H图解了在健康的动脉周围的动脉壁的圆周测量。
图1I图解了在再狭窄的动脉周围的动脉粥样硬化的圆周分布。
图2示意地图解了按照本发明的动脉粥样硬化物质导管系统。
图3示意地图解了用于重塑动脉粥样硬化物质的导管系统，所述系统包括图2的导管。
图4图解了图2的导管系统的可扩展篮和相关联的电极阵列。
图5和6图解了在圆周阵列中的具有交替的轴向偏差的电极的示例篮结构。
图7A-E图解了使用图2的导管系统的示例动脉粥样硬化物质重塑和/或去除方法。
图8-10示意地图解了用于在图2的系统中选择性地对电极供电的控制器。
图11图解了用于在图2的系统中选择性地对电极供电的另一个控制器。
图12A-12H图解了以独立的支柱形成的替代篮结构以及其部件，所述支柱具有用作电极表面的局部增大的宽度。
图13是示出通过不同的电极来施加不同的电源电平以便偏心地重塑动脉粥样硬化物质的示意横截面视图。
图14A-14E是通过人体内腔的截面侧视图，示出在此所述的治疗方法和装置的附加方面。
图14F-14H是通过人体内腔和治疗装置而剖取的截面视图，用于示出偏心治疗方法和装置的附加方面。
图15A和15B图解了在明胶动脉模型中的偏心治疗装置和方法。
图16是示例导管组件的透视图。
图17A图解了通过纵向移动的血管内物理目标定位。
图17B图解了通过径向电极激活的血管内物理目标定位。
图17C图解了通过径向和纵向电极组合的激活的物理目标定位。
图18图解了有疾病和无疾病组织的电阻抗对频率特性。
图19图解了通过包围低阻抗组织而使高阻抗组织屏蔽电流。
图20图解了使用多个径向相间隔的电极的电阻抗测量。
图21图解了多个频率治疗的变化。
图22图解了与电阻抗测量相结合使用来自外部来源的物理组织特性来确定期望的或者最佳的能量设置。
图23图解了在多个电极上分布的四电极测量系统，用于测量接触和组织阻抗。
图24图解了非离子流充溢管道，以将能量引导到管壁和周围的组织，减少了在原始流中的损失。
图25图解了闭环控制系统的一个实施例，使用来自例如IVUS的外部来源的组织信息来自动诊断和治疗血管内的病变。
图26A图解了在外部控制箱中的开关机构。
图26B图解了在导管的远端的开关机构。
图26C图解了在导管的近端的开关机构。
图27图解了斑块的选择性治疗。
图27A-27C图解了组织的光谱相关，可以用于分析或者表征斑块。
图28A-28D图解了使用以所述导管系统的一个示例实施例治疗的动物脂肪模型的组织的台顶部(bench top)重塑。
图29A-29B图解了使用导管系统的一个示例实施例的血管内成像和偏心重塑。
图30是图解可以用于内腔内组织和其他物质分析和表征的图2的系统的部件的简化示意图。
图31A-31J图示了在一个频率范围内的相角和阻抗之间的关系，其可以用于电分析和表征与图2的系统的电极接合并位于所述电极之间的物质。
图32图解了用于通过图2的系统的表征和选择性治疗的多种组织。
图32A-32C图解了在与组织的治疗相关联的频率范围内的相角和阻抗之间的关系中的变化以及在治疗前后的组织的组织学图像。
具体实施方式
本发明提供了用于分析和/或治疗内腔组织的装置、系统和方法。本发明对于表征和重塑沿着部分阻塞的动脉的物质以便打开动脉内腔并且提高血流量将特别有用。重塑可以包含向诸如电极和天线等的能量提供表面施加电外科能量(通常是以射频和/或微波电势的形式)。可选地，这个能量被控制以便限制目标和/或旁边组织的温度，例如将易损斑块的纤维状帽或者动脉结构的内膜层的加热限制到在从大约50到大约60摄氏度的范围内的最大温度。在许多实施例中，将所述能量控制为将血管的外层或者外膜(adventitia)的最大温度限制到不超过大约摄氏63摄氏度。将足以引发脂类池的融化并且同时禁止加热其他组织(诸如内膜层或者纤维状帽)的对易损斑块的脂类池的加热限制到小于在从大约50到大约60摄氏度的范围内的温度可以禁止否则可能导致再狭窄的免疫响应，等等。多个实施例可以施加足够的热能，以将脂类加热到大约85摄氏度或者更高，同时通过选择性地施加加热能量而禁止旁边的伤害。较为温和的加热能量可以足够来通过组织对于所述治疗的治愈响应来在治疗期间、在治疗后立即和/或在治疗后多于一个小时、多于一天、多于一周或者甚至多于一个月期间使得动脉粥样硬化物质变性(denature)和收缩，以便提供更大的血管内腔和改善的血流。
在一些实施例中，动脉粥样硬化斑块的重塑可以包括使用更大的能量来从身体的内腔内消融和去除阻塞的物质，特别是从血管去除动脉粥样硬化物质，以便改善血流。这样的消融可能产生消融碎屑，并且所述消融碎屑可能是溶解血栓的或者非溶解血栓的。当通过消融产生溶解血栓的碎屑时，可以从治疗位置抑制、捕获和/或排出所述碎屑。可以不必从血管抑制和/或排出通过消融而产生的非溶解血栓的碎屑。身体内腔的分析和/或治疗区域可以至少部分地(或者实际上全部地)被隔离以用于消融或者其他重塑治疗，以便允许修改治疗环境(例如通过冷却内腔和/或使用冷却的流体冲洗和/或非等渗流体冲洗等改变在内腔内的流体的电特性)以限制任何重塑碎屑的释放等。本发明的技术经常提供电外科能力、适合于测量动脉粥样硬化和/或血管壁的感测或者成像和/或栓子抑制(emboli inhibitor)。因为动脉粥样硬化可能在50％的时间相对于血管的轴偏心，因此有可能在75％(或者更多)的情况下，本发明的装置和方法经常特别适合于偏心地引导治疗，经常是响应于圆周的动脉粥样硬化物质检测或者成像。虽然在此所述的方法和装置允许这样的偏心治疗，但是所述装置也可以用于通过选择性地围绕导管等的轴以径向对称模式引导能量而治疗径向对称的动脉粥样硬化。
因此，动脉粥样硬化物质的重塑可以包括动脉粥样硬化和其他斑块的消融、去除、收缩、融化等。可选地，动脉的层内的动脉粥样硬化物质可以被变性以便改善血流，从而不一定产生碎屑。类似地，动脉层内的动脉粥样硬化物质可以被融化，并且/或者治疗可以包含动脉层中的动脉粥样硬化物质的收缩，而同样不一定产生治疗碎屑。本发明也可以提供治疗易损斑块或者其中易损斑块是所关心问题的血管的特定优点。这样的易损斑块可能包括偏心的病变，并且本发明可以特别适合于识别易损斑块结构的方位(以及轴向位置)。本发明也可应用于对帽结构进行目标定位以便温和加热(以引发所述帽的加厚，并且使得所述斑块不易于破裂)和/或加热易损斑块的高脂池(以便重塑、变性、融化、收缩和/或者重新分布高脂池)。
虽然可以与建立支架和/或球囊扩张相结合地使用本发明，但是本发明特别适合于提高其中建立支架和球囊血管成形不是可行选择的血管的打开直径。可能的应用包括治疗扩散的疾病，其中，动脉粥样硬化沿着动脉的实质长度分布，而不是被集中在一个区域中。本发明也可以通过下述方式在治疗易损斑块或者其中易损斑块是所关心问题的血管的治疗中提供优点：通过可能识别和避免以与易损斑块分离的、所选择的偏心和/或轴向治疗来治疗易损斑块，并且通过有意消融和吸出在受控环境区域内的或血管内腔内的区域内的易损斑块的帽和脂类池。本发明也可有益地用于治疗曲折的、锐弯的血管，因为支架不需要伸到许多血管的锐弯内或者在许多血管的锐弯内扩展。另外的有益应用包括沿着分叉(其中侧分支阻塞可能是问题)和在诸如腿、脚和手臂的外部四肢(其中挤压和/或支架破裂故障可能产生问题)中的治疗。
本发明的实施例可以测量电路的阻抗，特别是包括与内腔壁或者其他组织耦合的电极的电路的阻抗。交流(AC)电路的这样的阻抗测量经常包括测量阻抗的实数部分或者数值与阻抗的虚数部分或者相角。由耦合到所述电极的组织在适当的频率产生的阻抗数值和相角可以提供组织特征。为了增强组织特征测量的精度，可以进行多个独立的测量(经常是三个或者更多)并进行平均。通过在一个频率范围内的多个不同的频率(例如大约100个不同的频率)测量组织特征，可以产生组织的特征简档，所述特征简档可选地包括在整个频率范围内的相角和幅值的曲线或者曲线拟合。在一些实施例中，可以比较信号组织特征测量值，并且/或者，可以在组织特征简档中包括较小数量(2-10或者5-50)的这样的测量值。组织特征测量值可以依赖于测量条件(包括电极/组织耦合的配置)，特别是当通过在由柔性和/或径向可扩展的支撑结构支撑的两个电极之间发送双极组织感测电流而执行所述测量时。尽管如此，不同病人的不同组织的相对组织特征和/或特征简档(特别是特征简档之间的相对偏差和特征简档的相对斜率等)经常足够一致，以允许组织特征和特征简档用于在健康的组织、 钙化的斑块、纤维状的斑块、高脂斑块、未治疗的组织、部分治疗的组织和完全治疗的组织等之间进行区分。
可选地，可以进行组织的基准(baseline)测量(其可以经由血管内超声波或者光相干层析X射线照相等被表征)来帮助区分不同的相邻组织，因为组织特征和/或特征简档可能因人而异。另外，组织特征和/或者特征简档曲线可以被归一化以便利识别不同组织之间的相关斜率和偏差等。一旦已经在多个病人的不同组织的组织特征(包括阻抗数值、相角和频率)和特征简档与测量条件之间建立了足够的相关，则可以提供至少一些病人的组织表征，而不必依赖于其他基准组织表征方法。
在图1A和1B中分别图解了扩散疾病和易损斑块。图1C图解了血管弯曲。图1D图解了在分叉处的动脉粥样硬化物质，图1E图解了可能从四肢的动脉粥样硬化疾病产生的病变。
图1F图解了可能从腐蚀和/或疲劳产生的支架结构构件破裂。支架可以例如被设计10年的植入寿命。随着支架接受者的人群活得更长，越来越可能这些支架中的至少一些保持植入的时间长于它们的设计寿命。如同在腐蚀的身体环境中的任何金属那样，可能发生材料变差。当金属由于腐蚀而弱化时，支架可能破裂。当金属支架腐蚀时，它们也可能产生外来身体反应和副产品，其可能刺激邻接的身体组织。这样的疤组织可能例如导致动脉的最后再次关闭或者再狭窄。
可以参考图1G-1I来理解动脉剥离和再狭窄。动脉包括三层：内皮层、中层和外膜层。在血管成形期间，内层可以分层或者部分地从壁分离，以便形成图1G中所示的剥离。这样的剥离转向并且可能阻挡血流。通过比较图1H和1I可以理解，血管成形是较为侵入性的过程，其可能伤害血管的组织。响应于这个伤害，响应于支架的存在，并且/或者在原始动脉粥样硬化疾病的持续发展中，被打开的动脉可能再狭窄或者随后在直径上减少，如图1I中所示。虽然药物洗脱支架已经呈现出减少了再狭窄，但是还没有充分研究在植入几年后这些新结构的功效，并且这样的药物洗脱支架不适应于许多血管。
总地来说，本发明提供了一种导管，其较快和容易被医生使用。本发明的导管系统可以允许动脉被打开到它们的标称或者原始动脉直径的至少85％。在一些实施例中，动脉可以被打开到大约85％，并且/或者，尖锐的开口可能小于85％。可以使用足够的功率将组织局部加热到超过大约100摄氏度以便蒸发组织来进行快速的堵塞物质去除，或者可以使用更温和的重塑。
在一些实施例中，可以在通过导管系统的治疗后，立即获得期望的开口直径。或者，可以实现更温和的消融，例如，当治疗完成时提供不超过50％的原始直径，但是，由于以类似于心律不齐和经尿道的前列腺治疗的左心室消融的方式的被伤害内腔组织的再吸收，可以在随后的治愈处理完成后仍然提供80％或者甚至85％或更多的原始血管打开直径。这样的实施例可以将至少一些阻塞组织加热到在从大约55摄氏度到大约80摄氏度的范围内的温度。在一些实施例中，阻塞组织可以被加热到在大约93和95摄氏度之间的范围中的最大温度。在此处描述的其他实施例中，可以控制加热以便提供在大约50和60摄氏度之间的范围中的组织温度，一些实施例受益于大约63摄氏度的最大组织温度。更进一步的治疗可以受益于大约90摄氏度的治疗温度。有益的是，可以使用本发明的导管系统和方法，而不用使用球囊血管成形，由此避免剥离并且可能限制再狭窄。可选地，如果适当的话，可以在单个外科手术期间或者在一个月或更长的时间之后(甚至在一年或更长时间之后)重复在此所述的组织的治疗来提供内腔的期望开口。
在图2和3中示意地图解了一种示例导管系统10。重塑和/或消融导管12包括导管体14，其具有近端16和远端18。导管体14是柔性的，并且限定导管轴20，并且包括吸入内腔(aspiration lumen)22和冲洗内腔(irrigation lumen)24(参见图3)。另外的内腔可以被提供用于引导线或者成像系统等，如下所述。内腔22可以用于动脉粥样硬化的感测和/或成像以及吸入。
导管12包括接近远端18的径向可扩展的结构26以及接近近端 16的外壳28。远尖端30可以包括整体的尖端阀门，用于密封吸入内腔22，并且允许引导线和成像和/或再狭窄禁止导管等的通过。
近端外壳28包括第一连接器32，其与吸入内腔22流体连通。吸入内腔22可以具有位于可扩展结构26内的吸入端口，以便允许从所述可扩展结构内吸入碎屑和气体。也可以将吸入内腔22用作引导线、血管内成像导管和/或伸向远端的血管内辐射治疗导管或者再狭窄禁止药物的访问内腔。因此，连接器32可以选择性地容纳成像导管34，其具有动脉粥样硬化物质检测器36，所述动脉粥样硬化检测器36可以在导管体14中前进到接近和/或超越远端18，所述检测器经常包括血管内超声波换能器、光学相干层析X射线摄影传感器、MRI天线等。成像导管34的成像传感器38向显示器39发送成像信号，其允许圆周测量轴20周围的动脉粥样硬化厚度。
连接器32也容纳了再狭窄禁止治疗导管40，所述治疗导管在此包括血管内辐射导管。这样的辐射导管可以包括辐射源42，其同样可以在导管体14内向远端行进到或者超越可扩展结构26。
近端外壳28的第二连接器44与冲洗内腔24(参见图4)流体连通。第二连接器44可以耦合到冲洗流体源，用于引入传导性的或者非传导性的液体、气体等，理想地用于引入气体或者肝素化的盐。第一和第二连接器32和44可选地包括标准连接器，诸如Luer-LocTM连接器。在图3中，连接器44被示意地示出为耦合到吸入真空源/注入流体源45。
现在参见图2、3和4，近端外壳28也容纳电连接器46。连接器46包括多个电气连接，分别经由专用导体52电耦合到电极50。这允许电极50的一个子集被容易地供电，所述电极经常被使用双极或者单极RF能量供电。因此，电连接器46经常经由控制器47耦合到RF发生器，并且控制器允许能量选择性地被引导到被接合的内腔壁的偏心部分。当使用单极RF能量时，可以例如通过外部电极或者在导管体14上的电极来提供病人的地。处理器49可以操纵来自成像导管34的信号以在显示器39上产生图像，可以协调吸入、冲洗和/或者治疗， 并且可以自动以所述图像记录所述治疗。
处理器49通常包括计算机硬件和/或软件，经常包括一个或多个可编程的处理器单元，用于运行用于实现在此所述的一个或多个方法的一些或者全部的机器可读程序指令或者代码。所述代码经常被包含在有形媒体中，诸如存储器(可选地，只读存储器、随机存取存储器或者非易失性存储器等)和/或记录媒体(诸如软盘、硬盘驱动器、CD、DVD或者存储棒等)。所述代码和/或相关联的数据和信号也可以经由网络连接(诸如无线网络、以太网、因特网或者内联网等)被发送到处理器或者从处理器被发送，并且可以经由一个或多个总线在导管系统10的部件之间和在处理器49内发送所述代码的一些或者全部，并且经常在所述处理器内包括适当的标准或者专用通信卡、连接器和电缆等。处理器49经常被配置来通过使用软件代码编程所述处理器而至少部分地执行在此所述的计算和信号发送步骤，所述软件代码可以被写为单个程序或者一系列独立的子例程或者相关程序等。处理器可以包括标准或者专用的数字和/或模拟信号处理硬件、软件和/或固件，并且通常具有足够的处理能力来在病人的治疗期间执行在此所述的计算，所述处理器可选地包括个人计算机、笔记本计算机、图形输入板计算机、专用处理单元或者其组合。也可以包括与现代计算机系统相关联的标准或者专用输入装置(诸如鼠标、键盘、触摸屏和游戏棒等)和输出装置(诸如打印机、扬声器、显示器等)，并且可以在各种集中或者分布式数据处理架构中使用具有多个处理单元(或者甚至独立的计算机)的处理器。
在图4中更详细地图解了可扩展结构26。可扩展结构26当从限制护套被释放时可以弹性地扩展，或者可以通过将尖端30拉向远端18(参见图2)(可选地使用牵线或者内部导管体58等)而扩展。在此的可扩展结构26包括打孔结构或者篮，其具有一系列结构支柱(struct)或者元件54，并且在其间有开口或者穿孔56。穿孔56可以例如通过在柔性管材料中切出细长缝隙而形成，或者所述篮可以通过编织细长导线或者带子等而被形成。
可扩展的结构26一般包括近端部分60、远端部分62和其间的中间部分64。每个电极50被沿着中间部分64安装在相关联的篮元件54上，并且相关联的导体52从电极向近端延伸。电极50以阵列形式围绕轴20圆周分布，相邻的电极最好是轴向偏移，理想地在远和近轴向位置之间交替。这允许双极能量在相邻的圆周(轴向上偏移)电极之间、在相邻的远端电极之间、在相邻的近端电极之间等被引导。
在所述示例实施例中，近端和远端障碍物66、68在径向上随着可扩展结构26的近端和远端部分60、62扩展。障碍物66、68禁止在电极50附近产生的任何消融碎屑和气体在身体内腔中行进到超过导管12。障碍物66、68也允许例如通过将血管内的血替换为更有益的流体环境(用于限制电极的炭化等)而在身体内腔中建立至少部分地隔离的消融环境。可以取代障碍物66、68或者与其组合地提供替代障碍物，包括一个或多个在轴向上相对于可扩展件26偏移的一个或多个球囊或者弹性唇片等。在其他实施例中，可以进行重塑，而不产生大的散热消融碎屑，并且/或者，可以提供具有局部冲洗和/或吸入流的期望的治疗环境，以便一些系统可以放弃使用障碍物。
通过在诸如镍钛合金或者NitinolTM管道的超弹性合金管道中切出缝隙来形成一个示例的可扩展结构26。可以参见图6理解，可扩展结构54可以具有圆周宽度80，它们在接近电极和/或者电极安装位置82的位置被增加。可以在图5中看出，在电极安装片82附近的宽度80的局部增加可以在轴向上偏移，如上所述。形成可扩展件54的缝隙和可扩展件本身可以例如是0.8英寸长，所述可扩展件具有大约0.25英寸的圆周宽度。
现在参见图7A和7B，可以看到可折叠的圆锥体形式的可扩展障碍物的侧视图和端视图。障碍物66包括被涂敷例如硅树脂(通过将诸如NitinolTM编织物的超弹性合金编织物浸在液体硅树脂中，并且使它硬化)的编织的NitinolTM线84。这样的圆锥体可以然后被安装在可扩展结构的近端和远端部分上。如上所述，可以使用多种替代的障碍物薄膜。图7C图解了篮75，在所述篮上直接地涂敷了整体障碍 物77。障碍物77包括聚氨酯、其可以防止流泪。替代障碍物薄膜可以包括其他的材料，诸如PTFE等。
现在参见图8和9，由聚酰亚胺合金可扩展件54支撑的示例电极50可以被涂敷高温聚合物。导体52如上所述从电极50向近端扩展。高对比度的辐射透不过的标志(marker)(诸如金、铂、铂/铱合金等)可以被附接到这些支柱上或者附近。所述标志也可以用作电极。
可以参见图7A-7E来理解用于从血管内重塑和/或去除偏心动脉粥样硬化的导管系统10的使用。可以在图7A中看到，访问治疗位置经常包含将引导线GW在血管V内向前伸到动脉粥样硬化物质AM的目标区域并且更经常地伸到超出所述目标区域之外。可以使用多种引导线。对于访问具有完全堵塞的管道，引导线GW可以包括适合于穿过这种完全堵塞的任何市售引导线，包括Safe-CrossTM射频系统引导线，其具有朝前的光学相干反射测量和射频消融。当动脉粥样硬化物质AM不产生内腔的完全堵塞时，不必在引导线GW中提供这样的能力，虽然可以提供其他有益的特性。例如，引导线GW可以包括远端球囊，用于将引导线固定在位，并且进一步禁止消融碎屑等的移动。引导线GW可以被定位在荧光镜(或者其他)成像装置之下。
导管12在引导线GW上向远端延伸，并且被定位在动脉粥样硬化物质AM附近，经常朝向堵塞物的远端部分，可以参见图7A和7B理解。可扩展结构26在血管的内腔内部径向扩展，以便电极50径向地接合动脉粥样硬化物质AM。可扩展结构26可以例如通过下述方式而被扩展：通过将通过导管体14延伸的牵线拉到(直接或者间接地)耦合可扩展体26的远端部分62(参见图4)。或者，可以相对于外部导管体14向近端移动内导管体58，并且内导管再次耦合到可扩展体的远端部分。其他的替代方式也是可能的，包括从可扩展体周围撤下护套，并且允许所述可扩展体向外部径向弯曲。在至少一些实施例中，不论是从导管12的近端被启动还是仅仅通过释放可扩展体，用于限定可扩展体的结构件可以包括弹性的或者超弹性的材料，其被处 理来向外部径向扩展，诸如通过热固超弹性NitinolTM金属或者聚酰亚胺等。在一些实施例中，在定位消融导管和/或扩展篮后，引导线GW可以被去除。当动脉粥样硬化物质AM围绕导管12偏心地分布时，一些电极50直接地接合内腔壁W，可以参见图7B和7C理解这一点。
成像导管34位于导管12的内腔内，以便检测器42延伸到相邻的动脉粥样硬化物质AM。所述成像导管在导管12内和/或通过导管12而工作，以便测量在图7C中所示的围绕导管12同心的动脉粥样硬化物质的厚度，并且经常在多个轴向位置进行测量，以便测量在血管内的动脉粥样硬化物质AM的轴向变化，这样的测量经常在近端进行。在许多情况下，动脉粥样硬化物质AM如图7C中所示在血管内偏心地分布。应当注意，血管壁的任何部分都不必被动脉粥样硬化物质完全露出，以便测量分布指示阻塞是偏心的，因为沿着血管的一个部分或者侧面的动脉粥样硬化的较薄的层可能在厚度上与在血管V的相对侧上的动脉粥样硬化物质的很厚层很不相同。在一些方法中，沿着一侧的所有动脉粥样硬化的重塑和/或消融可能导致仅仅在治疗开始后电极/血管壁接合。
在一些情况下，成像导管34可以允许识别和/或表征在血管内的动脉粥样硬化物质、斑块、组织和病变等。例如，成像导管34可以确定要治疗的目标斑块的轴向和/或圆周位置。当意欲对动脉粥样硬化斑块进行治疗以便增强通过内腔的血流时，可以专门设计所述治疗来短期和/或长期地增加内腔直径和血流。当导管34识别出圆周和/或径向定位的易损斑块时，可以对该易损斑块进行目标定位以进行适当的处理，以经常通过下述方式禁止溶解血栓的物质的有害释放：通过加厚易损斑块的纤维状帽，使得所述斑块不易于破裂或者减少易损斑块的高脂池的大小或者从其释放的危险等。因此，可以使用导管34来提供与可以通过组织学获得的类似的信息，以便指示动脉粥样硬化的构成(通过识别和定位例如纤维状帽、平滑的肌肉细胞、脂类池和钙化等)。血管内超声波导管现在能够进行这样的动脉粥样硬化表征，并且这些表征也可以通过光学相干层析X射线摄影血管内导管、血管 内MRI天线和其他基于导管的成像系统，或者通过非侵入成像形式，诸如MRI系统等提供。
可以从多个制造商买到用于本导管系统的适当成像导管。可以例如从SciMed Life Systems和Jomed-Volcano Therapeutics(血管内超声波导管的提供商)、Light LabTM成像(开发和商业化用于血管内成像的光学相干层析X射线摄影导管)、Medtronic CardioRhythm等买到适当的技术和/或导管。可以使用另外的替代技术，包括超快磁共振成像(MRI)、电阻抗动脉粥样硬化深度测量和光学相干反射等。
在此所述的系统、装置和方法可选地使用至少部分地(也可以完全地)位于身体内腔之外(可选地，位于病人人体之外)的成像技术和/或动脉粥样硬化物质检测器装置。可以使用的非侵入成像形式包括X射线或者荧光透视系统、MRI系统和外部超声波换能器等。可选地，也可以使用外部和/或血管内动脉粥样硬化物质检测器来提供温度信息。例如，具有MRI天线的系统可以检测组织温度，以便可以在系统显示器上提供治疗渗透的图示。也可以从超声波和/或光学相干层析X射线摄影系统获得组织温度信息，并且可以将温度信息用作用于引导正在进行的治疗的反馈和用于选择治疗的组织的反馈(例如通过识别热的或者易损的斑块)等等。
像引导线GW的定位和导管12的伸入那样，可以通过荧光透视或者其他成像形式来帮助成像导管34的传感器30的定位。可以通过邻近传感器36的导管34的辐射透不过的标志，并且通过可扩展结构26的辐射透不过的结构(或者位于可扩展结构26之上或附近的对应的辐射透不过的标志)和/或通过使用辐射透不过的电极来帮助传感器36相对于可扩展结构26的定位。
通过在血管V内扩展可扩展结构26，可选的近端和远端障碍物66、68(参见图4)可以形成一个至少部分地并且优选地基本上在血管内隔离的环境。该环境可以被适配来通过下述方式改善随后的重塑和/或消融：通过从在近端和远端障碍物66、68之间布置的吸入内腔22的端口吸入血，并且通过使用期望的流体来冲洗所述隔离的环境， 如上所述。当被提供时，可以执行所述吸入和/或冲洗，可选地为同时地执行，以便在所述受控的环境中产生流，以去除任何蒸发气体和消融碎屑等。
现在参见图7C和7D，圆周成像经常指示重塑和/或消融应当针对血管壁W的偏心部分或者区域R。为了有助于向圆周动脉粥样硬化分布对齐(register)电极，可扩展结构26的一个支柱具有可识别的图像，允许所述支柱作为旋转对准键。可以使用血管内的成像(诸如血管内的超声波(IVUS))、光学相干层析X射线摄影(“OCT”)和/或血管内MR等，可选地使用诸如荧光透视或者磁共振成像(“MRI”)等的外部成像来对齐所述电极。也可以使用电子对齐。响应于这个信息，RF能量被引导到在区域R内的电极。这些被供电的电极限定了电极的整体阵列的一个子集，并且可以使用如下所述的控制器来实现电极的这个子集的选择。
已经很好地描述了在血管内的消融动脉粥样硬化物质的机制，包括Slager等在题目为“Vaporization of Atherosclerotic Plaque bySpark Erosion”，J.of Amer.Cardiol.(June，1985)，pp.1382-6的文章和Stephen M.Fry在“Thermal and Disruptive Angioplasty：aPhysician’s Guide”，Strategic Business Development，Inc.，(1990)的描述，它们的公开通过引用被包含在此。另外，在美国专利5,098,431、5,749,914、5,454,809、4,682,596和6,582,423中也描述了用于在本系统中适配和/或使用的适当的蒸发方法和装置。这些参考文献的每个的全部公开内容通过引用被包含在此。
现在参见图7E，如上所述，不必从血管内完全地去除所有的动脉粥样硬化或者动脉粥样硬化物质。提供具有标称原始内腔直径的至少80％或者85％的有效直径的开放内腔就是足够的。重塑治疗可以提供在从大约30％到大约50％的范围内的精确有效的开放直径。在一些实施例中，使用被供电的电极或者其他能量引导表面对于动脉粥样硬化物质的伤害可能引起随后再吸收被伤害的组织病变，以便在作为治愈处理的一部分的治疗终止后进一步打开血管。
为了促进长期的功效并且禁止血管V的经治疗区域的再狭窄，再狭窄禁止导管40可以通过导管12的内腔前进，以便辐射源42辐射血管的治疗区域。从NovosteTM、Guidant和Johnson&Johnson等可以买到适当的血管内辐射导管。类似于现在在药物洗脱支架上使用的那些的再狭窄禁止药物也可以通过导管12的内腔前进，可选地同时远端和近端障碍物再次帮助在血管内保持受控环境区域，以便可以限制或者避免全身的药物提供。除了在药物洗脱支架上使用的已知再狭窄禁止药物之外，可以使用引起血管舒张的药物。也可以使用诸如RapamycinTM的已知再狭窄禁止药物。
在一些实施例中，可扩展结构26可以相对于血管壁W和/或动脉粥样硬化物质AM保持扩展，同时导管12在血管内移动，所述导管经常在消融治疗期间或者之间被拉向近端。例如当测量血管的温度以便在现在由Volcano Therpeutics正在开发和/或市售的系统中检测易损斑块时，使用径向扩展的穿孔篮的类似移动。或者，可以重复地收缩所述篮，导管12的轴向移动用于重新定位篮，篮随后在沿着动脉粥样硬化物质AM的多个治疗位置中的每一个扩展。可以使用重复的血管内成像或者围绕导管12的圆周的其他的动脉粥样硬化物质厚度测量，并且经常暂时中止重塑和/或消融，以便使得可以在消融过程期间间歇地获取图像。可以获得最后的图像以验证重塑和/或消融已经成功。
现在参见图8和9，替代的控制器92ca、92b选择性地使用从RF发生器94提供的RF功率来对导管12的电极供电。可以使用多种RF能量类型，包括500Khz的脉冲串和不同类型的波形等。在控制器92a中，将简单的拨盘96转到指向要供电的期望的电极对。“键”电极可以通过下述方式与血管内成像系统对齐：或者以电的方式或者通过提供电极、电极支撑件或者附接的标志(在血管内成像显示器上提供清楚的图像)。这简化了沿着动脉粥样硬化选择一个或多个偏心电极对。有益的是，导管12不必旋转到适当的方位以精确地重塑和/或消融期望的偏心动脉粥样硬化物质。控制器92b包括类似的能力， 但是允许操作员选择用于驱动其间的双极RF能量的多个电极，在允许同时对多个电极供电时提供了更大的灵活性。也可以使用类似于图8和9的那些的单极控制装置，可以参见图10来理解这些。可以通过病人接地板或者与篮26相距2-5厘米的环形电极等来实现病人接地。同样，不需要导管旋转以将导管的活动侧定位到接近作为目标的动脉粥样硬化，因为可以通过电极选择控制器来选择各种偏心消融方位。
在图11中图解了一种替代的控制器。这个控制器允许操作员对于每个电极选择是否保持该电极不激活，是否将该电极电耦合到能量源(诸如RF发生器等)的第一极(有时称为极A)，或者将该电极电耦合到能量源的第二极或者极B。这个控制器允许多种被供电的电极配置，包括伪单极模式，其中，除了一个之外的所有电极连接到能量源的一个极(极A)，并且一个电极连接到另一个极(极B)。每个电极(在这个实施例中有8个电极)电耦合到编号从1到8的三路开关。位于中间位置的一个开关表示所述电极未耦合到任一个极，而被推向正号的开关表示相关联的电极被耦合到所述控制器的红色RF连接器。类似地，被推向负号的开关表示相关联的电极电耦合到控制箱的黑色RF连接器。
在图12A-12H中图解了一种示例性的可自扩展的篮。可以从这些附图理解，可以将电极制造为支柱172的一部分，由此例如使用位于支柱的轴向中间部分的每个支柱的局部加宽的径向向外的表面形成篮，如可以在图12B和12E中看到的。每个臂可以从一片材料形成，所述材料可选地包括NitinolTM镍钛成形记忆合金，并且支柱可选地从一个NitinolTM管激光切割。所述电极/篮可以例如被涂敷高温聚合物，诸如聚酰亚胺。电极174可以通过下述方式被形成：通过禁止涂敷，或者从相关联的支柱172的期望部分去除涂敷(如图12E中所示)，以便所述电极表面被暴露以与动脉粥样硬化物质接触。至少活动电极表面可以被涂敷高导电金属，诸如金、银或者铜合金等，并且涂敷材料最好保持并耐受篮结构的柔软性，涂敷材料可选地被滚动等。通过将导电电极限制到适当配置(经常是径向向外定位)，可以限制在电 极和血或者内腔内的其他导电流体之间的电耦合。所述支柱可以彼此分离，并且在结构上被绝缘材料(诸如紫外线(“UV”)治疗或者加热收缩套、聚乙烯或NylonTM等)支撑以形成篮170。
每个支柱172可以用于在电极表面174和电极导体(从支柱近端向控制器延伸)之间传导能量。在图12C中示出了用于连接这种导体的近端片，而在图12D中示出了远端结构片178。相邻的电极174可以在轴向上偏移或者间隔，如在图12F中所示。沿着每个支柱172的绝缘涂层可以被禁止或者从近端片176的内表面去除，以便有助于相关联的导线的连接(诸如通过点焊等)。也可以使用替代的聚合物或者非聚合物绝缘材料，同时可以使用用于将支柱172附接到导管体的替代方法，包括使用绝缘的UV固化的粘合剂接合和在聚乙烯中嵌入片结构等。
在图12G中图解了用于将篮170的支柱172固定到导管体180的示例结构。
现在参见图12F-12H。可以理解一种替代的标记，用于提供可识别的图像，用于旋转地将篮170的所选择电极174对齐到图像或者其他的动脉粥样硬化物质测量物。在这个实施例中，被称为电极1的电极174i可以具有辐射透不过的标志182，其位于相关联的支柱172i上。支撑相关联的第二电极174ii的支柱172ii可以使得两个辐射透不过的标记182提供圆周不对称的计数指示器，允许不模糊地参考所有的电极。电极50的形状可以不同，例如，电极174可以比在图12A-G中所示的支柱172的其他部分更宽。
经常使用冲洗和/或吸入流来执行重塑。在许多实施例中，冲洗端口将诸如盐溶液的流体从冲洗内腔引导到篮的内部。吸入端口可以提供在吸入内腔和篮的内部之间的流体连通。这些流体流之一或者两者可以被连续地驱动，或者可以替代地在治疗之前、期间和/或之后脉动。在一些实施例中，吸入和/或冲洗流可以剧烈地或者同时地发生，以便在冲洗端口和吸入端口之间循环。可选地，所述流可以向吸入端口传送消融碎屑，其中，所述碎屑可以通过吸入内腔来排出。在冲洗 系统和吸入系统之间可以存在协调，以便冲洗流体可以保持被限制在很接近篮的区域中，以便当篮在血管内扩展时禁止消融碎屑的栓塞。这样的协调例如可以禁止消融碎屑的远距离移动，并且/或者可以消除对于远端和/或近端障碍物或者薄膜的任何需要。在一些实施例中，在冲洗端口和吸入端口之间的流体的循环可能产生接近电极的有效的无血环境，以便利重塑和/或消融、以及脉粥样硬化组织的成像等。
现在参见图13，在此所述的导管系统的控制器可以允许向不同电极对分布不同的功率电平。例如，响应于例如在图13中所示的动脉粥样硬化物质AM的圆周分布，控制器可以向第一电极230引导50瓦的能量，向一对第二电极232引导30瓦的能量，并且仅仅向一对第三电极234引导10瓦的能量。其他电极可以没有被引导到其的能量，如上所述。在一些实施例中，可以通过控制工作周期来提供被引导到不同电极的不同功率，例如通过在50％的时间中激活一个或多个电极而提供50瓦，通过在30％的时间中对一个电极供电来提供30瓦，等等。
通过将图像检测结构定位在诸如由NitinolTM形成的篮的金属结构中，许多成像形式(包括血管内超声波、光学相干层析X射线摄影和血管内MRI等)可能至少部分地被阻挡或者变差。因此，可能在产生诸如包括塑料或者聚合物的篮的替代可扩展结构中有优点。根据由在此所述的系统的电极产生的热量，有益的是，这样的聚合物篮结构包括高温聚合物，诸如聚酰亚胺。替代篮结构可以包括HDPE、PET、NylonTM和PEBAXTM等。可以通过从聚合物材料的管切割支柱来形成所述篮。
在图14A-14H中图解了示例治疗方法。在图14A中，导管系统260包括在动脉粥样硬化物质检测和治疗导管264上的篮覆盖护套262，如上所述。在这个实施例中，外部篮护套262径向限制篮266，其当从外部护套释放时被偏置以在径向上扩展，如图14B中所示。在一些实施例中，可以在收回所述外部护套后扩展篮，例如通过拉动牵线或者将导管的一部分相对于另一部分旋转等等。无论如何，当篮在 血管V内扩展时，篮的电极50与周围的血管壁接合。在治疗导管的内腔内布置的成像导管的靠近篮266的成像换能器壁评估血管V，并且所述检测/治疗导管系统264被沿着动脉或者血管V拉向近端。
当成像导管检测到在图14C中所示的动脉粥样硬化物质AM时，激活适当的子集(有可能仅仅包括单个电极50)以重塑动脉粥样硬化物质AM，如在图14D中所示，并且打开的血管内腔大小在治疗期间适度地提高。所述导管被拉到下一个动脉粥样硬化附近，在此对其进行检测和治疗。在图14F中示意地图解了在治疗之前的所述有限打开内腔的截面，其也图解了导管264的盐冲洗内腔268。在图14G的截面中示意地图解了治疗能量和血管V的打开内腔直径的适度增加。在治愈响应逐渐地提高打开内腔的直径后，可以提供在图14H中示意地图解的更长时间打开内腔的结果。
现在参见图15A和B，显示了在明胶动脉模型270中的偏心物质去除。在测试之前，所述动脉模型包括在图15A中所示的一致内腔272。具有支撑电极的圆周阵列的可扩展篮的测试偏心治疗导管274被引入内腔272中，并且可扩展篮支撑与内腔壁接合的电极。测试导管274的所选择的电极被供电以便偏心地处理明胶动脉模型274，由此实现明胶模型的偏心重塑，在这种情况下是通过沿着内腔272的一侧去除偏心体积276。通过选择性地对测试导管274的电极供电来控制被去除的物质的方位和数量。
现在参见图16，图解了示例导管系统280。在这个实施例中，导管体282仅仅包括单个内腔，其足够大以在其中容纳成像导管，并且也被用作冲洗内腔以将冲洗流体导入冲洗端口284中。所述内腔可以在冲洗端口284的远端在直径上减少，并且被减少直径的部分286适配地在其内腔内容纳所述成像导管，以便将冲洗流体在径向上向外引导通过多个冲洗端口。当使用在图14A-14H中图解的方法来重塑动脉粥样硬化物质时(其中，温和的加热改善了血管大小，并且可以不要求吸入)，这个实施例特别有益。
导管体282可以包括编织轴，其中，导线(例如铜线或者铍铜导 线)被涂敷高温和/或高强度的绝缘材料，诸如聚酰亚胺层等。所编织的导线可以夹在形成导管体282的轴的材料的层之间。所述轴可以例如包括多个聚乙烯层、内TeflonTM PTFE层和外尼龙层等。
轴282的导线可以被编织使得当电流通过它们时禁止在导线之间的电容损耗。当从能量源向导管系统的电极传送电流的导线和将电流从电极向回传送给能量源的导线不平行，而是以一个角度、理想地是垂直时，可以减少电容损耗。这可以通过以适当的间距或者每英寸多个峰值来编织导线来实现。可以包括导管系统280的篮结构170，所述篮结构参见图12A-12H被更详细地描述。引导器286可以通过篮170扩展，并且可以包括对于成像导管透明的材料，可选地包括HDPE或者PET等。
可以获得另外的替代方式。例如，使用RF能量来重塑动脉粥样硬化物质的另一个方式可以是以不同的RF信号来对多个相邻的电极供电，以便将相邻的电极用作相位阵列。相位阵列可以使用在所述阵列的相邻元件的信号之间的相加干涉和相消干涉来在期望的方向上引导或者操纵电磁信号。通过控制相邻信号的相位，电极的相位阵列可以提供集中的和/或可操纵的RF信号。
伴随着控制操纵和定向，调整相邻RF电极的相位可以允许在动脉粥样硬化物质内的期望深度D聚集一些或者大部分RF能量，同时使用在信号之间的相加干涉和相消干涉来在电极表面和深度D之间禁止RF能量提供。例如，这样的系统可以用于保护斑块的帽以便减少再狭窄。在将能量向斑块的内部聚集的同时禁止帽的加热可以降低对于热的免疫响应，其否则会导致再狭窄。因此，禁止帽的加热可以减少再狭窄。
总地来说，本发明可以使用高度弹性的、可扩展的结构，特别是从被穿孔分隔开以便限定篮的结构元件形成的可扩展结构。这样的结构可以符合在动脉粥样硬化物质去除之前、期间和/或之后的动脉直径。这个可扩展性允许电极直接接触动脉粥样硬化，虽然本发明的系统也可以使用传导流体环境来完成RF能量路径，或者相反使用非传 导流体来增强被引导通过组织的能量。多个电极可以在围绕可扩展结构的中间部分在圆周之上被分布，并且这些电极的子集可以被激活以允许偏心组织重塑和/或消融。
可以通过血管内成像来识别动脉粥样硬化并对其进行目标定位，并且这些能力可以被集成到重塑和/或消融导管中。优选的是，所述血管内成像能力将被部署在独立的导管中，其可以在消融导管中前进或者从消融导管被去除。一般，这个血管内成像能力允许监控治疗的进展，以便可以防止壁穿孔，同时理想地将阻塞减少到不大于整个原始血管直径的15％(在完成治疗时或者在随后的组织治愈之后)。消融导管还可以允许使用局部辐射或者药物提供来用于动脉粥样硬化治疗。消融导管可以包括较大的内腔，允许选择性地使用血管内成像系统、辐射提供或者其他治疗导管、碎屑和蒸发气体的吸入，这些手段的使用经常被依序采用。引导线可以使用这样的或者独立的内腔，并且可以去除引导线以允许访问再狭窄和/或成像导管。
如上所述的装置、系统和方法非常适合于向沿着身体内腔的目标组织和物质施加被专门设计的电能。
在此所述的使用的示例导管装置和方法意欲应用在人体解剖学的血管的内腔中。被置入导管的解剖结构可以例如是食道、口腔、鼻咽腔、耳咽管和鼓室、脑瘘管、动脉系统、静脉系统、心脏、喉、气管、支气管、胃部、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、阴道腔和子宫颈管道。
可以参见图17A-17C理解，通过沿纵向在血管内移动直到位于目标组织附近而定位电极，可以完成偏心疾病的物理目标定位。如在图17A中所示意地图示，在身体内腔304中的导管302形式的探针远端的轴向移动允许对内腔壁的不同轴向部分进行目标定位来用于分析和治疗。用于物理地以径向方式对偏心疾病进行目标定位的另外的方法是向特定的电极306选择性地施加双极能量，以便将能量引导通过目标组织，可以参见图17B理解这一点。在一些实施例中，可以通过选择性地启动在可扩展体310上径向和纵向分布的电极来进行径向 和纵向物理目标定位，如在图17C中所示。
在图18和19中图解了组织的频率目标定位。如在图18中图示，不同的组织类型具有不同的特征电气阻抗，其使得所述组织比其他组织更容易吸收特定频率或者频率范围的能量。通过以所述组织更易导通的特定频率或者频率范围来施加能量，能量更容易穿透所述组织。一般，已经示出，有疾病的组织的样本呈现出比健康组织的样本更高的阻抗特征。如图19中所示，在通过较为健康的组织314来围绕组织312的有疾病区域的情况下，由于健康组织的较低阻抗，所述健康组织有可能将有疾病的组织与电流屏蔽。因此，最小(或者小于期望电流的)电流318可以通过有疾病的组织312，并且当在电极316之间传输双极电流时，可以在低阻抗健康组织314中看到更大的电流320。通常，其中组织阻抗改变到有用程度的频率范围在100KHz和10MHz之间发生。
通过确定有疾病的组织的阻抗等于或者小于健康组织的阻抗的频率或者频率范围(诸如通过在图18中图示的门限值频率322或之上的操作)，频率目标定位寻求向有疾病的组织提供更大的能量。在指定的频率或者频率范围提供的能量将使得比在那些特定频率之外提供的能量更多的热量发散在有疾病的组织中。
可以参见图20理解用于确定组织的位置和/或状态的阻抗测量的使用。首先，使用在内腔332内的径向间隔的电极330的阵列的阻抗测量可以用于分析有疾病的组织334。当电流路径通过有疾病的组织334时，并且当它通过内腔壁的健康组织时，在所述阵列的5个电极之间的阻抗测量，特别是在相邻电极对之间(和/或在分离的电极对之间)的阻抗测量可能不同。因此，在有疾病的组织334的任一侧上的电极之间的阻抗测量可以指示病变，而其他相邻电极对之间的测量可以指示健康组织。所述阻抗表征组织的分子状态。组织的状态可以被温度影响/改变：例如，脂类在85摄氏度开始变性，并且转入新的状态脂肪酸，其在体积上比原来的脂类紧凑90％。
如果知道组织的状态改变的温度以及组织的不同状态的阻抗，则 通过测量所述组织阻抗，可以检测状态改变，并且估计温度是多少，由此允许监控治疗的进展。例如：如果脂类的阻抗是100欧姆并且脂肪酸的阻抗是90欧姆(在此使用假设值)，并且知道脂类在大约85摄氏度转化为脂肪酸，则检测到从100欧姆向90欧姆的阻抗改变指示脂类被转化为脂肪酸，因此，温度应当在85摄氏度左右。有疾病的内腔组织的分析可以使用特定频率来根据电阻抗测量验证组织的类型和条件。通常的使用将包括使用内腔内超声波或者其他方法来发现和表征有疾病的组织。在径向相隔的电极上的组织电阻抗的测量允许验证有疾病的组织的存在，并且知道电极相对于特定组织的位置。
在图21中图解了多频率治疗和信号。治疗可以包含以单个频率或者多个频率来施加电能。根据目标组织和周围组织的构成，最佳治疗可以包含用于对单个组织类型进行目标定位的单个频率、对多个组织类型进行目标定位的多个频率或者被施加到单个组织类型的多个频率。可以使用同一频率336的多个脉冲串、改变的频率(诸如改变的频率338的连续脉冲串)、多个频率340的脉冲串和叠加的多个频率(可选地在脉冲串342中)。
可以从与目标组织或者周围组织接触的电极的任何组合以任何顺序施加多个频率。可以以离散的频率施加多个频率，或者可以将其施加为以线性的、对数的或者其他方式在一个范围上扫描的频率。
在图22中示意地图解了一种能量控制方案。一般，可以使用阻抗和物理组织特征来设置所述输出或者治疗参数。如在此所述，可以使用IVUS或者其他的类似检测技术来确定几何形状或者组织类型。可以从多个电极测量电极阻抗。系统处理器的算法可以选择正确地初始剂量、初始设置和/或范围输出。
关于建立正确的初始剂量，一般通过超声波、光学或者其他类型的内腔内感测装置来诊断和表征要治疗的有疾病组织的形状和类型。使用多电极手段，可以使用电阻抗测量来了解预先诊断的、各种几何形状和类型的动脉粥样硬化组织的电特性。使用该数据，可以优化初始治疗剂量设置。
关于控制所述剂量，由于组织的温度改变和分子状态，组织的电阻抗特性改变。可以使用在施加能量期间的组织的电阻抗的动态测量值来监控在组织内的改变和治疗的进展。电极系统的四电极实现方式允许测量电极对组织界面的电阻抗，因此，允许测量在接触表面的组织的温度上的改变和接触组织的温度上的改变。
关于在治疗期间的适当剂量的确定，能量提供的模式可以是改变持续时间的单个脉冲或者多个脉冲，被所述改变的持续时间的剩余时段分开。组织的电阻抗的测量和在能量提供期间和在能量脉冲之间的电极与组织界面的测量值可以用于确定能量提供的最佳持续时间和剩余的时段。RF能量的处理前的脉冲串可以被应用来调节目标组织。可以在治疗之前使用调节来激活在健康组织中的热休克蛋白质(HSP)，以获得健康组织的更好保护。RF能量的处理后的脉冲串可以被施加来控制组织的冷却时间。RF能量的中间治疗脉冲串可以被施加来控制在多个治疗脉冲串之间的目标和周围组织的温度。可以以电极的任何组合的幅度和频率的任何组合来提供能量。
也可以使用在多个电极上的阻抗测量。当使用多电极设计时，有可能一些电极与内腔壁接触，而其他电极悬浮在血液或者其他现有的液体或者血栓中、或者现有的支架、或者外来物质等中。在各种径向位置上的阻抗的测量允许确定哪些电极与内腔壁接触，以及哪些电极与诸如血液的流体接触。这种接触确定可以与诸如超声波的内腔内观察装置组合地用于确定电极的物理方位。
使用多个电极之间的阻抗测量值，可以使用每个电极与组织或者血液的接触状态的确定来确定电极承载结构(导管)是否处于用于治疗的适当位置。可以使用多个电极之间的阻抗测量值来确定电极与组织的接触质量。不良的接触质量可能引起过度的或者不希望有的局部加热，或者可能妨碍最佳的治疗。可以使用接触质量的确定来使这种类型的问题最小化。
在一些情况下，可以通过接触位置和质量的组合来确定电极的选择。可以使用多个电极之间的阻抗测量来更好地理解哪些电极处于用 于治疗特定区域或者病变的更好的接触或者更好的位置。
在一些情况下，要施加到目标的能量电平和频率的确定可以基于接触质量。可以使用多个电极之间的阻抗测量来确定最佳的能量电平和频率。
在一些情况下，可以将能量施加到单对的电极、应用到多对电极之间或者从单个电极到多个电极或者其任意组合。可以利用多个电极之间的阻抗测量来确定最佳的模式。
不同的实施例可以使用利用2对4个电极的阻抗测量，可以参见图23理解这一点。四电极系统用于在许多应用中测量电阻抗。四电极系统比二电极系统固有地更精确，因为由于在接触区域中产生的过量的接触阻抗和电极化反应而在二电极系统中产生的不精确。在四电极系统344中，通过两个能量提供电极346来向目标提供能量，并且在被示意地示出在能量路径上与组织350接触的另外两个高阻抗电极348之间进行阻抗测量。在这个多电极应用中，可以使用任何两个电极来提供能量，同时可以使用任何其他两个电极来用于阻抗测量，因此形成了四电极测量系统。探针或者导管352可以包括圆周和/或径向分布的电极阵列，其可以用于接触组织，并且可以配置导管的任何四个电极来用于能量提供或者阻抗测量。因此，可以将所述电极阵列用作二或四电极系统。
在许多应用中，有益的是知道多少能量正在被提供到目标组织，以及多少能量正在电极和组织之间的界面中耗散。通过测量二电极系统然后测量四电极系统，电极与组织的界面可以被表征，并且可以使用该数据来确定多少能量正在所述电极与组织的界面中被耗散，以及多少能量实际上被提供到目标组织。
在二或四电极配置中的电阻抗的测量可以使用小的激励信号而静态地执行，或者可以在以正常的治疗电平施加能量期间被动态地测量。使用这种技术，可以在施加能量以确定被治疗的组织和周围的组织的状态期间动态地测量组织电阻抗。
可选地，可以以单极的配置来执行阻抗测量。可以在单极配置中 使用多电极系统，其中，返回电极是被施加到病人的外部表面等的导电片。在这种配置中，可以在二电极模式中在任何一个内部施加的电极和外部返回片之间进行阻抗测量，或者任何一个内部施加的电极可以施加流向外部返回片的能量，同时使用任何两个其他的内部施加的电极来测量阻抗。
关于温度测量，在治疗之前进行的阻抗测量可以用于计算归一化值以便用于另外的计算中来确定温度从该初始值的改变。在治疗期间对目标和周围组织的电阻抗的动态监控可以用于计算组织的温度的改变。在一些实施例中，动态监控电极和组织之间的界面的电阻抗可以用于防止组织碳化或者在界面的血液的凝结。
在治疗期间的温度改变可以用于确定能量提供设置的有效性，并且确定被治疗的组织的状况。
温度测量可以通过内腔内超声波或者其他机制而执行，并且通过从阻抗测量值得出的数据来被验证。
可以参见图24理解将在此所述的系统用于离子或者非离子流体。当电流在离子流体(诸如填充内腔356的血液)中流动时，当对电极358供电时所述电流的至少一部分可以通过血液。即使当电极在目标组织360的任何一侧上的时候，也可以通过在血液内的电流来减少目标组织的加热。
当用于诸如动脉之类的流体填充的内腔中时，这个装置可以与充溢区域362的非离子流体相组合地被使用，以将原始流体位移或者部分地位移以修改电极周围的环境的导电率。这个行为可能是被期望的，以便将电流364形式的能量引导到内腔壁中，而不是通过原来的流体，由此向周围的壁的组织提供能量，并且对填充内腔的流体的耗散最小。
非离子流体或者离子流体的第二目的可以是向电极提供冷却，并且向在表面上并且刚好在内腔壁的表面下的组织提供冷却。
在电极处的电阻抗测量可以用于确定周围的流体的导电率，因此测量在原始液体中的非离子流体的浓度。这个数据可以被提供到控制 系统，以允许调整离子流体浓度，以最佳化向目标组织的能量提供，并且最小化对于周围组织的不期望的影响。
将血液用作接触界面也是一种选择。血液是导电的离子流体，其可以被用作电极和组织之间的界面，以保证良好的电极组织接触和低接触阻抗。
可以参见图25而理解闭环控制。可选地，通过在治疗之前和治疗期间与诸如IVUS的伴随内腔内测量装置相关联，在频率范围上和多个电极上的阻抗测量可以用于验证电极相对于组织界标的位置。
利用系统处理器的硬件和/或软件使用闭环治疗控制器366的阻抗测量可以便利治疗控制。这种对频率范围和多个电极的控制可以用于监控和验证在施加区域中的物理改变，诸如组织收缩或者组织的变性。这个数据可以用于验证由诸如超声波之类的其他内腔内观察技术观察的物理改变。
与来自诸如超声波的内腔内测量装置370的输入组合的来自阻抗测量368的数据可以用于从控制器或者处理器模块372的预定规则组确定电极选择。这种类型的控制系统可以用于自动模式中以诊断和治疗有疾病的内腔内组织。
关于组织的状况的数据，可选地包括温度改变、电极与组织的界面阻抗、组织阻抗、电极与组织或者血液的接触和来自超声波或者其他来源的内腔内几何形状和组织类型可以被控制器用作到闭环控制系统366的输入。
电极开关的实现可以使用多种选择性激励电极电路、开关类型和开关位置等的任何一种，并且其中一些被示意地图解在图26A-26C中。
电极开关可以被定位在外部仪器或者外部控制箱374中，以便向导管378的导管的每个电极提供一个外部连接器点380，并且每个电极380的一条导线延伸到所述导管体，在导管体中延伸并且/或者沿着导管体延伸。或者，电极开关机构386、388可以被分别嵌入在导管382、384中，或者靠近所述导管的近端以用于外部开关，或者接近导 管的远端以用于内部开关。有限数量(例如4个)的导线390可以在所述开关机构的近处延伸，而每个电极的一条导线可以在开关机构的远处延伸。可以通过机电或者固态部件来实现离散电极与RF发生器或者阻抗测量装置的连接。
位于导管的远端的开关机构具有优点。如果位于导管上，则所述开关机构可以位于远端以减少在导管体内或者在近端的导线的数量。在位于导管的远端的开关机构的实施例中，外部控制电路可选地经由用于阻抗测量的相同导线而与所述开关部件通信。
也可以使用在导管上的近端或者其他位置的开关部件。如果所述开关部件位于导管上的近端或者任何其他位置在性能和成本上有优点，则所述开关部件可以位于导管上的近端或者任何其他位置。
现在参见图27，在此所述的导管装置418、系统和方法经常用于治疗具有纤维状组织420的斑块。纤维状组织420可以被加热到目标组织到在从大约90到大约95摄氏度的范围中的温度，其可以提供达到大约50％的收缩。脂类424可以被加热到在从大约80-85摄氏度的范围内的目标温度，提供达到大约90％的收缩。对于外膜的层426的损害可以被禁止，或者通过将加热限制到低于大约62摄氏度而保护所述层。可以通过适当地经验测试等从未出版的和/或已经出版的著作或者从其他来源来确定这些和其他温度和收缩估计。参见图27A-27C，与有疾病的组织的频谱相关可以使用诸如在下文中所述的那些的技术来允许组织表征：Tjeerd J.Romer等，名称为“Histopathology ofHuman Coronary Atherosclerosis by Qualifying Its ChemicalComposition with Raman Spectroscopy，”Circulation 97：878-885(1998)。
现在参见图28A-28D，可以使用诸如在此所述的那些的导管系统来在台式试验中看到组织收缩的可行性。通过使用组织重塑电外科能量(参见图28B)、在治疗期间人工地保持可扩展结构和导管的相关联的电极与组织的表面接触，可以治疗动物脂组织模型430(在图28A中示出治疗之前)。在治疗后，如图28C和图28D的环中所示，可 以验证组织的可见收缩。可以通过下述方式来验证使用在此所述的方法和系统的血管内成像的使用的可行性：通过图29A中的导管的可扩展结构的6个独立的电极支撑支柱428的图像，并且通过查看偏心空隙430，所述偏心空隙430是使用良性引导的重新整形能量提供而建立的，从而提高有效动脉直径以获得更好的血流，如在图29B中所示。
现在参见图30，有益的实施例可以使用在下文中所述的电子组织识别技术和装置的方面：US.Patent No.6,760,616，授予Hoey等人，名称为“Tissue Discrimination and Applications in MedicalProcedures，”其全部公开通过引用被包含在此。如在该参考文献中更全面地所述，组织识别系统510包括用户可读输出装置512、用户输入装置516、处理器520和探针522。处理器520包括中央处理单元(“CPU”)514、数模转换器(“D/A”)和模数转换器(“A/D”)518。处理器520可以被包括在处理器49中(参见图2和3)，探针522可以包括在此所述的导管结构的任何一种，因此组织识别系统510可以被包含在系统10中。
现在参见图30和31A，组织识别系统510可以通过使用可变频率电源524对电极供电而施加滑动或者可变频率电信号。电源524、探针522的电极和病人P的接合组织因此可以被包括在电路中，并且可以在不同的频率测量所述电路的电气特性。在示例实施例中，在大约4KHz到大约2MHz的频率范围内的多个频率测量所述电路的阻抗(相角和幅度)。每个频率/幅度/相角数据点可以表示组织特征测量，并且经常在类似的条件(例如在给定的频率并且不移动电极)下取一系列独立的数据点，并且平均所述一系列独立的数据点以获得更高的精度。所述组织特征数据点可以是在一个频率范围中的多个频率的测量值，以便产生频率/相角/相位幅度曲线，用于表示组织特征简档或者相关530、532或者534，其可以用于表征电路的组织。
经常在此处所述的导管的电极之间驱动用于得到组织特征简档530、532和543的信号。方便的是，可以通过选择用于测试的不同的电极对并且重新定位电极或者不用重新定位电极，控制在所述电路中 包括的组织。对于独立的组织特征测量，可能有很大的病人之间的差别(或者甚至在病人内的区域之间的差别)，并且这些差别可能至少部分地由测试期间的电极的不同配置和电极之间的不同距离等引起。尽管如此，关系(特别是简档相关的相对斜率和相关之间的偏差等)将充分一致以允许组织表征，特别是当使用IVUS或者OCT等来获得病人或者组织区域的基准组织特征简档时。当(例如)健康组织的区域可以使用IVUS被识别并且用于产生病人的基准组织特征简档时，可以将其他近端的组织特征测量值或者简档相对于基准归一化和/或与所述基准相比较等。从所述偏差和在斜率上的差别等，可以分析所述组织。
现在参见图31A-31J，可以使用在组织特征简档曲线或者相关之间的关系来分析和表征由探针的电极接合的组织。例如，与纤维状斑块相关联的相关530(在图31A的图的左侧所示)具有与钙化斑块534(在绘制数据的右侧中所示)和与血栓相关联的相关532(在530和534之间)大大不同的斜率和数值。所述相关之间的偏差涵盖了给定阻抗的相位差或者给定相位的阻抗差等。可以参见所述图示而理解，可以通过将曲线拟合到数据、通过统计分析或者通过查找表等来确定在相关之间的关系。在示例实施例中，可以用市售的向量阻抗表(诸如Hewlett-Packard Model No.4193A)来进行组织特征测量，并且可以使用LabViewTM软件来捕获所述相关，并且使用微软的ExcelTM表格软件等来绘制或者操纵所述相关。一旦已经获得了足够的基准数据并且已经建立了在不同的探针配置下的可重复性，则不用每个病人的基准的电路测量组织表征可以避免IVUS测量的花费。
现在参见图31B，伴随表征不同的组织，也可以将所述关系用作对于内腔壁的治疗的反馈。在治疗之前(向曲线的右侧)的纤维状斑块相关或者简档在治疗期间在数值上改变到治疗后的相关或者简档(向左侧)。在此的治疗包括2秒的电外科能量2W，示出可以使用组织识别系统510的电路的电特性来监控、验证和/或控制适度的重塑或者部分治疗。有益的是，一旦已经确定了一个适当的频率或者频率 范围，则不必产生整体组织特征简档来分析正在进行的组织治疗和/或组织的表征，因为可以容易地识别偏差。这样的测量可以例如允许确定组织温度，特别是当温度是改变组织特征的偏差的治疗温度时。用于组织分析的电信号的能量通常小于重塑治疗。在图31C和31D中示出了类似的曲线，在此的治疗后相关分别是治疗后2W持续9秒，和1W持续9秒。
现在参见图31E，健康组织(向右)和纤维状斑块(向左)之间的关系可以从它们的相关联的组织特征简档或者相关(它们在斜率和数值上都大大不同)被识别。图31F示出了在治疗之前(左)的纤维状组织、在治疗后的纤维状组织(右)和健康组织(中间)的相关或简档之间的关系。图31G-31J图解了在与纤维状组织和被治疗的纤维状组织相关联的简档或者相关之间的关系的附加曲线。
参见图32，可以看到具有三种基本的斑块类别的有严重疾病的血管：高脂(肥)斑块、纤维状斑块和钙化斑块或者组织。可能在一个样本中存在全部，并且可能在一个病变的有疾病的组织(或者靠近病变的有疾病的组织)中存在全部，使得难于使用传统技术来治疗所述病变。通过在此所述的组织分析技术，可以找到正确地处方和能量剂量，并且将其提供以在构成每个病变的构成部分的适当位置安全和适当地(并且经常是不同地)重塑不同的组织类别或者类型。
现在参见图32A，这个图示出了组织特征测量和从人主动脉样本获得的组织特征简档结果，这些结果用于治疗前后的接合的纤维状斑块。图32B和32C示出了组织的组织病理学幻灯片。在每个幻灯片上可见的裂缝可以是安装过程的人为产物。但是，在图32C中示出的核或者空隙可以指示组织本身的重塑。
虽然已经通过示例并且为了理解清楚而以某些细节描述了所述示例实施例，但是本领域内的技术人员可以认识到，可以使用多种修改、适应和改变。因此，本发明的范围被所附的权利要求完全地限定。
Claims (1)
1.一种用于分析血管的管壁的系统，所述系统包括：
血管探针，其具有近端、远端和电极，所述电极被布置在所述远端附近，用于接合所述管壁；
可变频率电源，其耦合到所述电极，以便当所述电极接合所述管壁时，可以限定包括所述电源、所述电极和所述被接合的管壁的电路；以及
处理器，其与所述可变频率电源耦合，所述处理器被配置来通过监控所述电路的频率相关特性而表征管壁的目标斑块。
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| CN107361841A (zh) * | 2016-05-11 | 2017-11-21 | 德国欧华内镜有限公司 | 医疗dc电流发生器和配备医疗dc电流发生器的双极医疗植入物分割装置 |
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-
2006
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- 2006-03-28 CN CN2006800164240A patent/CN101511292B/zh not_active Expired - Fee Related
- 2006-03-28 ES ES11191822.3T patent/ES2565342T3/es active Active
- 2006-03-28 AT AT06748830T patent/ATE542486T1/de active
- 2006-03-28 WO PCT/US2006/011341 patent/WO2006105121A2/en active Application Filing
- 2006-03-28 EP EP16154269.1A patent/EP3045110B1/en active Active
- 2006-03-28 EP EP06748830A patent/EP1865870B8/en not_active Not-in-force
- 2006-03-28 EP EP11191822.3A patent/EP2438877B1/en not_active Not-in-force
- 2006-03-28 US US11/392,231 patent/US7742795B2/en not_active Expired - Fee Related
- 2006-03-28 CN CN201110031923XA patent/CN102125430A/zh active Pending
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2010
- 2010-02-26 US US12/660,515 patent/US8364237B2/en active Active
-
2012
- 2012-02-27 US US13/406,458 patent/US20120157988A1/en not_active Abandoned
Cited By (5)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN105769192A (zh) * | 2016-02-24 | 2016-07-20 | 苏州润心医疗科技有限公司 | 一种冠状动脉斑块的多频三维检测方法 |
| CN105769192B (zh) * | 2016-02-24 | 2019-05-14 | 苏州润心医疗器械有限公司 | 一种冠状动脉斑块的多频三维检测方法 |
| CN107361841A (zh) * | 2016-05-11 | 2017-11-21 | 德国欧华内镜有限公司 | 医疗dc电流发生器和配备医疗dc电流发生器的双极医疗植入物分割装置 |
| US11246647B2 (en) | 2016-05-11 | 2022-02-15 | Ovesco Endoscopy Ag | Medical DC current generator and bipolar medical implant fragmentation device equipped therewith |
| CN107361841B (zh) * | 2016-05-11 | 2022-03-11 | 德国欧华内镜有限公司 | 医疗dc电流发生器和配备医疗dc电流发生器的双极医疗植入物分割装置 |
Also Published As
| Publication number | Publication date |
|---|---|
| EP3045110A1 (en) | 2016-07-20 |
| EP1865870B1 (en) | 2012-01-25 |
| US20120157988A1 (en) | 2012-06-21 |
| US8364237B2 (en) | 2013-01-29 |
| WO2006105121A3 (en) | 2009-04-16 |
| EP1865870A2 (en) | 2007-12-19 |
| ES2565342T3 (es) | 2016-04-04 |
| US7742795B2 (en) | 2010-06-22 |
| CN101511292B (zh) | 2011-04-06 |
| WO2006105121A2 (en) | 2006-10-05 |
| EP1865870B8 (en) | 2012-04-04 |
| ES2380487T3 (es) | 2012-05-14 |
| EP2438877A3 (en) | 2012-07-11 |
| US20100168743A1 (en) | 2010-07-01 |
| US20060235286A1 (en) | 2006-10-19 |
| EP2438877A2 (en) | 2012-04-11 |
| EP2438877B1 (en) | 2016-02-17 |
| CN101511292A (zh) | 2009-08-19 |
| EP1865870A4 (en) | 2009-12-16 |
| EP3045110B1 (en) | 2019-07-31 |
| ATE542486T1 (de) | 2012-02-15 |
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Application publication date: 20110720 |