CN103068330A - 用于治疗组织的功率发生和控制装置 - Google Patents
用于治疗组织的功率发生和控制装置 Download PDFInfo
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Abstract
提供了生成并控制能量的按剂量输送以引出病变组织中的治疗反应的装置、系统和方法。球囊导管可以具有附接到功率发生器和控制器的电极,使得所述球囊和电极在能量治疗期间与组织相接触。可以基于测得的阻抗将能量选择性地施加到组织上以实现温和加热。通过在能量剂量之前计算所述电路阻抗以校准所述装置和识别所附接配件有利于在设定点附近调节功率输送。能量输送能够被控制以获得基本均匀的大块组织温度分布。能量输送可以有益地影响神经活性。
Description
相关申请的交叉引用
本申请根据35USC 119(e)要求2010年4月9日提交的美国临时申请No.61/342,191的权益;该申请的全部公开通过引用并入本文。
本申请的主题涉及在2006年3月28日提交的题为“Tuned RFEnergy for Selective Treatment of Atheroma and Other TargetTissues and/or Structures”的美国专利申请No.11/392,231、2004年9月10日提交的题为“Selectable Eccentric Remodeling and/orAblation of Atherosclerotic Material”的美国专利申请No.10/938,138、2006年10月18日提交的题为“Tuned RF Energy andElectrical Tissue Characterization For Selective Treatment Of TargetTissues”的美国临时申请No.60/852,787、2007年4月4日提交的题为“Tuned RF Energy and Electrical Tissue Characterization ForSelective Treatment Of Target Tissues”的美国临时申请No.60/921,973、2007年10月18日提交的题为“Tuned RF Energy andElectrical Tissue Characterization For Selective Treatment Of TargetTissues”的美国专利申请No.11/975,651、2009年11月12日提交的题为“Selective Accumulation of Energy With or Without Knowledgeof Tissue Topography”的美国专利申请No.12/617,519、2007年10月18日提交的题为“Inducing Desirable Temperature Effects on BodyTissue”的美国专利申请No.11/975,474、2007年10月18日提交的题为“System for Inducing Desirable Temperature Effects On BodyTissue”的美国专利申请No.11/975,383、2009年11月13日提交的题为“Selective Drug Delivery in a Lumen”的美国专利申请No.12/616,720、2009年9月22日提交的题为“Inducing DesirableTemperature Effects on Body Tissue Using Alternate EnergySources”的美国申请No.12/564,268以及2009年5月13日提交的题为“Directional Delivery of Energy and Bioactives”的美国临时申请61/177,744中的那些主题,这些文献的全部公开通过引用并入本文。
技术领域
本发明一般地涉及施加(或以其他方式使用)能量的医疗设备、系统和方法,并且涉及其中对电能的准确控制是有益的其他领域。在示例性实施例中,本发明提供用于在对管腔疾病的基于导管的治疗期间,尤其是在对动脉粥样硬化斑块、脆弱斑块或“热”斑块等的基于导管的治疗期间选择性地输送能量剂量的能量发生和控制装置。
背景技术
医生使用导管进入并修复身体的内部组织,尤其是在身体管腔(例如血管)内的组织。例如,球囊血管成形术和其他导管经常被用来打开因动脉粥样硬化性疾病而业已变窄的动脉。
球囊血管成形术在打开闭塞的血管时常常是有效的,但是与球囊扩张相关联的创伤可能导致显著的伤害,使得球囊扩张的益处可能有时会受到限制。支架通常用来延长血管的有益打开。
与球囊扩张相结合的支架术常常是用于动脉粥样硬化的优选治疗方法。在支架术中,折叠的金属框架被安装在引入体内的球囊导管上。支架被操纵以进入闭塞部位并且通过位于下方的球囊的扩张而原位扩展。支架术已经获得广泛的接受,并且在很多情况下产生普遍接受的结果。与血管尤其是冠状动脉的治疗一起,支架还能够用于治疗体内的很多其他管状闭塞例如用于治疗生殖、胃肠道、和肺闭塞。
已出现体腔在支架术之后的再狭窄或随后收窄的大量病例。最近,药物涂层支架(例如强生公司的CypherTM支架,包括SirolimusTM的关联药物)已被证明显著减小再狭窄速率,而其他公司也正在开发和商业化替代药物洗脱支架。另外,同样能改进手术血管成形术的成功率的系统药物输送(静脉或口服)的工作也已开始。
尽管药物洗脱支架看上去为许多很多患者体内的动脉粥样硬化的治疗提供了相当大的希望,但是存在其中支架不能使用或仍有重大缺点的诸多情况。一般性地,支架术在体内留下植入物。这种植入物会带来风险,包括机械疲劳、腐蚀等,尤其是在难以移除植入物且涉及侵入性手术的情况下。对于治疗弥漫性动脉疾病、治疗分叉、治疗易于压伤的身体区域、以及治疗经受扭转、伸长和缩短的动脉,支架术还具有其他缺点。
同样还提出了多种修改的再狭窄治疗或抑制血管再狭窄闭塞的治疗模态,包括常常与球囊血管成形术和/或支架术相结合的血管内照射、低温治疗、超声能量等。尽管这些不同的方法呈现出对在血管成形术和支架术之后减小血流的随后劣化的不同程度的希望,但是由血管成形术最初施加在组织上的创伤仍然是有问题的。
最近,已经注意到扩张的其他缺点。这些缺点包括易损斑块的存在,易损斑块会破裂并释放可能导致心肌梗死或心脏病发作的物质。
还提出了支架术和球囊血管成形术的大量替代方案用以打开狭窄的动脉。例如,已经公开并尝试了多种旋切术设备和技术。尽管血管成形术和支架术具有上述缺点和限制,旋切术尚未获得广泛的使用和基于扩张术的成功率。
另外,在减瘤病变组织以减轻或消除病变的领域中的方法(例如旋切术和消融术)通常提供很少(如果有的话)用于保护健康组织在治疗病变组织的过程中免受伤害的手段。
鉴于上述,有利的是提供用于改造体腔,尤其是血管组织的新设备、系统和方法。还期望的是避免显著的成本或复杂性,同时能够在无需诉诸极端扩张的创伤,伤害相邻的健康组织,以及容许打开不适于支架术的血管和其他身体管腔的情况下提供对体腔的改造。
发明内容
本发明涉及通过以受控剂量的方式输送能量来治疗组织。可以通过使用具有控制器的能量源施加能量、进行组织表征分析、且进一步地选择性赋能多个能量输送表面来靶向组织。
在示例性实施例中,用于功率输送的装置可以包括功率发生电路,所述装置还包括:功率发生源;放大器块;功率输出设定点控制器;在功率输送位置处的电压和电流反馈被用来测量在功率输送靶处的阻抗;接收所述电压和电流反馈的峰值有效功率传感器块;以及接收来自功率输送设定点控制器和峰值有效功率传感器块的信号的比例积分微分(PID)控制器,籍此PID控制器调制向所述功率放大器块的总输入电压,由此响应于在所述功率输送靶处测得的阻抗而使得来自所述电路的功率输出被维持在所述功率输出设定点附近的范围内。
在一些示例性实施例中,输出功率为射频(RF)功率,而在可选的示例性实施例中,功率可以呈超声、微波、激光的形式或其它合适的能量形式。
在一些示例性实施例中,用于输送的所述装置还可以包括导管,其中,所述导管还可以包括多个能量输送表面,最优选地是安装到可扩张球囊上的多个能量输送表面。
在一些示例性实施例中,提供了用于优选地校准装置的方法,所述方法包括使用多种负载以矢量网络分析计算功率电路阻抗,使得在功率发生期间测量的电路负载阻抗的实时变化的测量可以代表在所述装置的功率输送靶处的阻抗的实时变化。
在一些示例性实施例中,提供了一种方法,包括:通过反复校准以基于其阻抗特性确定所附接配件的类型而识别附接到所述装置上的配件。
在一些示例性实施例中,提供了一种以受控方式施加能量以在靶组织中实现基本均匀的大块温度分布的方法。
在一些示例性实施例中,提供了一种为了实现有益的生物反应而将能量施加到神经组织上以改变神经活性的方法。
本发明的优选实施例可以用于在组织中实现治疗性生物学效果的治疗程序。最优选地,本发明可以在血管成形术之前、期间和/或之后的任意点和任意时间使用。
在另一方面,本发明提供了一种用于治疗靶组织的功率发生装置。所述功率发生装置包括生成频率信号的频率合成器。功率放大器将频率合成器操作性地耦接至功率输出部。该输出部可耦接至靶组织,而功率传感器被配置为接收来自靶组织的电压和电流反馈,并被配置为输出在靶组织处测得的阻抗。控制器将所述功率传感器耦接到所述功率放大器上。控制器将功率传感器耦接至功率放大器。控制器具有用于接收功率设定点的输入部,且响应于功率设定点和在靶组织处测得的阻抗将调制信号发送给功率放大器,使得从所述功率放大器逐频率地向靶组织输出的功率被维持在功率设定点附近的期望范围内。
可选地,频率合成器包括数字频率合成器,例如直接数字合成器(DDS),并且数模转换器将频率合成器耦接至功率放大器。从装置向靶组织输出的能量典型地包括RF能量,但是可选地可以包括微波能量等。在很多实施例中,在系统中包括所述功率发生装置,而所述系统还包括细长导管。所述导管可以具有细长柔性导管本体,所述导管本体具有配置为在血管内前进的远端部。连接器能够耦接到所述本体的近端部上,而所述连接器被配置为耦接至所述输出部,使得在使用时所述导管将所述输出部耦接至与远端部相邻的靶组织。如通过所述系统的所述功率发生装置测得的所述靶组织的阻抗常常独立于所述功率发生装置、所述本体和/或类似物的阻抗。
在另一方面,本发明提供了用于在准备治疗靶组织时校准RF系统的校准模块。所述RF系统包括功率发生装置,所述功率发生装置包括阻抗测量电路。所述模块包括用于从所述功率发生装置的所述阻抗测量电路接收第一阻抗的第一输入部。所述第一阻抗对应于在将所述功率发生装置耦接到所述靶组织上之前在所述功率发生装置上的低电路负载。第二输入部相似地从所述阻抗测量电路接收第二阻抗但是对应于在所述功率发生装置上的高电路负载(同样在将所述功率发生装置耦接到所述靶组织上之前)。第三输入部从所述阻抗测量电路接收介于所述高负载与所述低负载之间的相似的第三阻抗。处理器被配置为使用所述测量阻抗计算系统阻抗以响应于在向所述靶组织的功率施加期间测量的总电路负载阻抗的实时变化而促进在所述靶组织处的阻抗变化。所述总电路负载阻抗包括所述功率发生装置的阻抗和在靶组织处的阻抗。
典型地,所述RF系统还包括用于将所述功率发生装置耦接到所述靶组织上的导管或其它耦接装置。更一般地,本文所述系统的总电路在使用期间可以包括功率发生电路、功率输出靶电路、和耦接电路,而所述总系统电路的这些部分中的每一个将相应的阻抗部分贡献给所述系统的总阻抗。为了帮助更准确地表征所述总电路的这些部分的阻抗贡献,并且为了更准确地测量在所述靶组织(或其它功率输出靶)处的阻抗,所述处理器能被配置为在将所述导管耦接至所述功率发生装置之后和在将所述导管耦接到所述靶组织上之前计算所述功率发生装置和所述导管的不同的系统阻抗。
附图说明
图1示意性地例示了用于与具有在功率系统中的电极的球囊导管一起使用的功率发生和控制装置的一个实施例。
图2示意性地例示了用于在图1的装置中使用的可扩张球囊的一个实施例。
图3A示意性地例示了图2的球囊的截面图。
图3B示意性地例示了用于使用图1的装置进行组织分析和选择性能量治疗时使用的电极的一个实施例。
图4示意性地例示了功率发生和控制电路的一个实施例。
图5示意性地例示了图4中所示的峰值有效功率传感器块的DDS下转换段的一个实施例。
图6示意性地例示了图4中所示的峰值有效功率传感器块的DC基带处理段的一个实施例。
图7示意性地例示了图4中所示的PID控制块的一个实施例。
图8示意性地例示了用于感测和控制入射和反射功率的两端口网络设计。
图9A示意性地例示了图4中所示的放大器块的一个实施例。
图9B例示了用于图4中所示的放大器块的“软电流限制”关系。
图10为在图1中所示装置的组织治疗实施例中的最大和最小测得电流的示例图。
图11为在图1中所示装置的组织治疗实施例中的最大和最小测得阻抗的示例图。
图12为在图1中所示装置的组织治疗实施例中的最大和最小测得电压的示例图。
图13为在图1中所示装置的组织治疗实施例中的靶部位和功率发生器处测得的功率的示例图。
图14A和图14B示意性地例示了使用用于图1中所示装置的实施例的经验性导出的能量剂量和阻抗控制而在管腔组织中的基本均匀的大块温度分布。
图15A和图15B示意性地例示了使用用于图1中所示装置的实施例的累积损伤理论导出的能量剂量而在管腔组织中的基本均匀的大块温度分布。
图16示意性地例示了用于校准功率发生系统以有利于准确测量在靶功率输出部处的阻抗的方法和系统。
具体实施方式
本发明的实施例涉及通常用于治疗靶组织以获得治疗作用的功率发生和控制装置。优选地,靶组织为管腔组织,其还可以包括例如在动脉疾病中发现的病变组织。
尽管本公开关注于本技术在脉管中的使用,但是本技术对其他管腔闭塞也是有用的。可以使用本发明的其他解剖结构为食道、口腔、鼻咽腔、咽鼓管和鼓室、脑静脉窦、动脉系统、静脉系统、心脏、喉头、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、和宫颈管。
用于使用RF、超声、微波和激光能量加热组织的设备已经在2007年10月18日提交的题为“Inducing Desirable Temperature Effects onBody Tissue”的美国专利申请No.11/975,474、2007年10月18日提交的题为“System for Inducing Desirable Temperature Effects OnBody Tissue”的美国专利申请No.11/975,383、2005年5月3日提交的题为“Imaging and Eccentric Atherosclerotic Material LaserRemodeling and/or Ablation C atheter”的美国专利申请No.11/122,263以及2009年9月22日提交的题为“Inducing DesirableTemperature Effects on Body Tissue Using Alternate EnergySources”的美国专利申请No.12/564,268中公开,通过引用并入本文的这些文献的全部公开内容可以与本发明相结合。
功率发生和控制
在本发明的很多实施例中,功率发生和控制装置可以包括内部电路400、控制软件、用户界面102、以及容纳电路400和用户界面102的功率发生和控制外壳101。
参照图1和图4,容纳在外壳101内的内部电路400可包括直接数字合成器(DDS)块401,块401的数字编码输出可以优选地通过数模转换器(DAC)402。DAC 402将来自DDS块401的数字编码信号转换为模拟电压信号414。电压信号414和模拟调制电压信号413优选地通过放大器(AMP)块403,从而得到靶功率输出404。在靶功率输出404处的电压和电流负载的测量值可以通过电压传感器405和电流传感器407进行测量,优选地来自电压传感器405和电流传感器407的信号可以分别通过模数转换器(ADC)406和408。来自ADC406的数字电压信号和来自ADC 408的数字电流信号优选地通过峰值有效功率传感器410接收,其中在功率输送靶404处的功率发生和控制装置的有效功率输出可被实时测量。功率设定点控制409基于软件编程的操作参数。
在图5和图6中所示的优选实施例中,峰值有效功率传感器块410可以包括DDS 500,DDS 500用来将电压感测信号V(来自406)和电流检测信号I(来自408)下混至DC基带信号,优选地产生经低通滤波器502的电压输出以及经低通滤波器504的电流输出。来自峰值有效功率传感器块410的电压和电流输出包括同相电流507、同相电压505、和正交电流508、正交电压506分量。对于电路410内的信号优选的是包括同相分量和正交分量,这是由于在电路410内的块可以随后识别在信号分量之间和通过电路401各个块的若干信号之间的瞬时幅度、频率和相移。来自峰值有效功率传感器410的低通滤波器502和低通滤波器504的数字输出信号可以随后发送到图6中所示的功率计算电路。
现在参见图6,电压幅度可以通过将同相电压信号505和正交电压信号506的平方相加,并且将总和通过平方根电路602而算出。电流幅度可以通过将同相电流信号507和正交电流信号508的平方相加,并且将总和通过平方根电路606而算出。未校正功率可以优选地通过将电压幅度和电流幅度相乘而算出。
电压信号的相位可以优选地通过将电压信号的正交分量506和电压信号的同相分量505通过反正切门603而算出。相似地,电流信号的相位可以优选地通过将电流信号的正交分量508和电流信号的同相分量507通过反正切门607而算出。余弦门608优选地接收来自反正切门603和607的差分输出,使得功率因子校正可以被算出。峰值有效功率可以通过将未校正功率乘以余弦门608的输出且使用舍入门609舍入结果而算出。
尽管图5和图6表示最优选实施例,但是峰值有效功率可以使用其他手段算出,例如将瞬时RF电压和RF电流波乘在一起,并且将所得的信号积分以获得平均值;用于计算峰值有效功率的手段从适于所用功率类型且适于部件(包括在本文公开和描述的装置的电路)的任意可用手段中选取。
现在参见图9A和图9B,放大器块403可以包括可变增益放大器901,其接收来自DDS块400的电压信号414并调制来自PID控制器411的电压信号413;以及功率放大器902。功率放大器902具有如图9B中所示的“软电流限制”,籍此当所需输出电流增大时以裁剪方式减小可用输出电压。具有软电流限制的功率放大器902的优点在于所输送的最大输出功率能够由电流限制电路的特性固有地限制,其中电流限制电路可以提供在较大范围的负载阻抗上的、最优选地超过十个负载阻抗上的基本恒定的最大可用输出功率。软电流限制方案的另外的优点在于,当使用开关模式电源技术进行实施时,能够在较大范围的负载阻抗上、优选地超过约十个负载阻抗上获得极高的功率放大器效率。
靶功率输出404的控制可以优选地通过将信号发送到PID控制器411的功率设定点控制409和峰值有效功率传感器块410获得,其中PID控制器411可以最终产生送入放大器块403的调制电压信号413。功率输出设定点控制409可以提供基于编程操作参数的软件控制信号,编程操作参数在很多实施例中可被设定为以避免对周围健康组织的伤害的方式促进病变组织的改造。通过在功率输出404处进行实时负载同相和正交测量,电路400由此能够通过调制输出使得输出可以在从设定点的较小范围内变化而表征和响应负载变化。在设定点附近的功率输出变化可以为约±2%,但是,优选实施例可以在其他范围(例如约±5%、约±10%、约±15%、以及约±20%或更大)内调节输出变化。
现在参见图4和图7,PID控制器411优选地接收来自功率输出设定点409和峰值有效功率输出块410的输出信号。PID控制器411可以包括硬件和/或软件模块,用以执行分别为Kpe(t)、Ki0∫τe(τ)dτ、和Kdde(τ)/dt的比例计算701(“P”)、积分计算702(“I”)、和微分计算703(“D”),其可以表述为理想形式的方程Vm(t)=Kpe(t)+Ki0∫τe(τ)dτ+Kdde(τ)/dt,其中Vm(t)表示计算的调制电压413作为时间响应于在输出404、峰值有效功率计算410和功率设定点409处的测得功率的函数。
其中:
Kpe(t)表示对测得/算出功率与期望功率的误差的比例反应;
Ki0∫τe(τ)dτ表示对测得/算出功率与期望功率的误差的总和的积分反应,其中τ表示进行积分的时间段,而e(t)表示在当前时间t处的算出功率;以及
Kdde(τ)/dt表示对测得/算出功率与期望功率的误差的变化率的微分反应。
在最优选实施例中,PID方程可以表述为更常见的“标准”或“工业”形式Vm(t)=Kp[e(t)+1/Ti0∫τe(τ)dτ+Tdde(τ)/dt],其中,常数Ki和Kd由分别代表积分和微分时间值的Ti和Td代替。该标准形式提供了在控制方程中简化微分和使用常数的优点。
在优选实施例中,在靶功率输出404处的功率测量值与功率计算值之间存在约160微秒的时间间隔“t”。411的PID控制回路的输出计算可以被称为“被操纵变量”或调制电压414,其优选地用来驱动放大器块403以调节输出功率紧密靠近设定点。常数Ki、Kp和Kd帮助定义电路400可以如何快速地响应于输出404中的误差增大、或者如何快速地调制放大器块403以减小在404处的输出与设定点409相比时的误差。功率计算704优选地基于DDS块401的输出的正交电压分量506和同相电压分量505、以及正交电流分量507和同相电流分量508。
现在参见图1和图8,包括外壳101内的功率发生器和控制装置以及附接配件100'(其例如可以包括图1的导管组件108和连接器103)的总装置100可以利用例如图8中所示的通信方案。尽管图8描绘了利用两端口网络800的优选实施例,但是可以取决于给定功率控制应用的期望布置而采用其他数量的通信端口。通常,在电压传感器405、电流传感器407和靶负载(组织)404之间常常存在显著的RF损失、反射和相移。这些RF损失、反射和相移导致输送给负载(组织)404的实际功率的显著偏差,并且另外地导致在负载(组织)阻抗的测量中的显著误差。在优选实施例中,一般化的2-端口反射计用来相对于准确控制负载(组织)功率以及准确测量负载(组织)阻抗两者来补偿在RF路径中的所有RF损失、反射和相移。为此目的,两端口网络800可以包括利用在外壳101内的功率发生器和控制装置、附接配件100'、以及在靶功率输出404处的负载之间的入射和反射功率波的一系列控制计算,从而优选地得到受控于外壳101内的功率发生器和控制装置的电压和电流输出800V&I。
入射功率波由下标“an”表示,反射功率波由下标“bn”表示,在404处的入射和反射功率分别由“aL”和“bL”表示。为了清楚起见,在图8中表示的数学运算的下述说明中,数学方程应当省略在图8中所示的说明性元件的附图标记“800”以简化所述方程的含义。
散射参数就入射和反射功率波(分别为an和bn)而言的两端口网络定义为:
其中,a1和b1为在发生器101处的入射和反射功率波,而a2和b2为在负载(例如,电极112)处的入射和反射功率波。
用于两端口网络的S-参数矩阵连同扩展公式一起可被定义为:
b1=S11a1+S12a2 6.
b2=S12a1+S22a2 7.
在发生器101(其可以包括电路400)和负载404处的复数阻抗可以分别定义为rho(ρ)和gamma(Γ)。Rho和gamma优选地可以随后使用入射和反射功率波定义为:
现在可以使用方程1至方程9的关系推出从rho空间到gamma空间的反向变换,如下所示:
方程18提供从rho空间向gamma空间的反向变换的明确形式。散射参数可以被分组且优选地以下述形式定义为反向变换系数A、B和D:
A=S11 19.
B=S12 2-S11S22 20.
D=-S22 21.
方程18可以通过将系数A、B和D代入反向变换的优选明确形式内而简化,从而提供优选一般形式的反向变换:
使用方程22,且求解gamma,可以以优选形式推出正向变换:
ρ+DΓρ=A+BT 23.
DΓρ-BΓ=A-ρ 24.
Γ(Dρ-B)=A-ρ 25.
以与方程19至方程21相似的方式,正向变换系数A'、B'和C'可以优选地用来如所示地简化在gamma空间与rho空间之间的方程:
方程12可以通过将系数A'、B'和D'代入正向变换的优选明确形式内而简化,从而可以提供优选一般形式的正向变换:
在负载404处的正向功率可以优选地定义为入射到负载404上的功率波的平方的大小:
PFL=|aL|2=|b2|2 32.
相似地,来自负载404的反向功率可以定义为由负载404反射的功率波的平方的大小:
PRL=|bL|2=|a2|2 33.
通过以上定义的关系,在靶功率输出负载404处吸收的功率也可以通过下述关系定义为入射功率减去反射功率:
PL=PAL-PRL 34.
PL=|aL|2-|bL|2 35.
并且将方程7、方程9和方程32代入方程34至方程36内,提供了扩展形式的关系:
PL=|aL|2{1-|Γ|2} 37.
PL=PFL{1-|Γ|2} 38.
PL=|b2|2(1-|Γ|2) 39.
PL=|S12a1+S22a2|2(1-|Γ|2) 40.
在最优选两端口网络中,现在可以定义在端口1处的入射和反射功率。在800a1处的入射功率可以优选地定义为在800a1处入射的功率波的平方的大小:
PF1=|a1|2 41.
并且在800b1处的反射功率可以优选地定义为在800b1处反射的功率波的平方的大小:
PR1=|b1|2 42.
在端口1处吸收的功率(“P1”)可以使用方程41和方法42定义为在端口1处的入射功率减去在端口1处的反射功率:
P1=|a1|2-|b1|2=|a1|2(1-|ρ|2) 43.
其也可以定义为所吸收电压的大小乘以所吸收电流的大小乘以在所吸收电压与所吸收电流之间的角度的余弦:
P1=|V||I||cosφ|=|a1|2(1-|ρ|2) 44.
将方程9代入方程7内且求解b2可以定义以下对于图8中的800b2定义的关系:
b2-S22a2=S12a1 46.
b2(1-S22Γ)=S12a1 48.
现在可以通过将方程49代入方程39内且通过将方程45代入方程51内扩大分子而定义在图8中的负载404处的功率:
在本发明的优选实施例中,可以测量图4的电路400中的已知阻抗,由此定义变换系数A、B、D和A'、B'、D',如能够参照图16所理解的。最优选地,对已知电路负载404进行三次测量,最优选地,阻抗ZρO在约1000Ω的负载下获得,阻抗ZρS在约50Ω的负载下获得,而阻抗ZρL在约150Ω的负载下获得,其中在功率发生器和控制装置101处的复电压和电流测量值(图8的800V&I)被用来使用方程53计算ZρO、ZρS和ZρL,其中SYSTEMIMPEDANCE(系统阻抗)给定为150Ω的值。但是,用于计算ZρO、ZρS和ZρL的已知电路负载和给定SYSTEMIMPEDANCE可以以介于约零欧姆与约无限欧姆值之间的其他值范围执行。如图16中所示,这种校准方法可以在将功率发生部件耦接到靶组织上之前并且理想地在将配件100'耦接到外壳101内的功率发生电路400上之前开始1601。三种不同的负载施加有在每个负载处获得的阻抗1602、1603和1604。这些测量值使用电路400的部件获得,并且被输入到硬件模块和/或软件模块内以用于本文所述地系统特征计算。
求解方程53可以优选地涉及最优选地使用网络分析、最优选地使用矢量网络分析的一组预备的阻抗测量值,以优选地提供在约1000Ω、约50Ω和约150Ω的相应负载处的阻抗ZΓO、ZΓS和ZΓL。六个优选的阻抗测量值ZΓO、ZΓS、ZΓL、ZρO、ZρS和ZρL随后可被优选地用来计算变换系数A'、B'、D':
A'=ZГS-B*ZρS+D*(ZГS*ZρS) 56.
由方程54至方程56优选定义的系数值现在可以优选地用来使用方程31计算在图4的靶功率输出404处的实际负载阻抗,并且使用方程52计算在靶功率输出404处施加的实际功率,从而优选地提供来自PID控制器411的算出的调制输出电压413,使得基于负载的实时变化将404处的输出在设定点附近准确地调节,并且将功率输送维持在如本文所述的范围内。
在优选实施例中,在功率输送点处的实际功率输出最优选地基于在输出404处测得的施加负载的复阻抗角。其中,负载最优选地表示组织,而复阻抗角优选地表示健康或病变组织和/或在装置100的使用过程中组织状态的变化。另外,由于阻抗是电容和电阻的函数,因此实时组织电容和实时组织电阻也可以通过在阻抗、电容和电阻之间的关系而基于测得的数据获知:
考虑阻抗可以具有实数(real)成分和虚数(Imaginary)成分,方程57中的关系还可以表述和推导如下:
其中,ω表示电路的固有频率,C表示在负载处测得的实时组织电容,而R表示在负载处测得的实时组织电阻。
对方程61求解C2且将方程63代入方程62,并且对方程64求解C:
通过对方程65求解ω2C2R2且代入方程61内,可以获得简化的关系:
现在,实时组织电阻可以通过从方程57获得的阻抗Z的已知值(通过简化方程66且求解R)而确定:
而实时组织电容可以通过将方程67代入方程65且求解C而确定:
在图1的系统或总装置100的最优选实施例中可以包括图4的电路400和耦接装置或配件100',其可以在表征和选择性治疗组织时一并使用以促进治疗响应。基于阻抗、成像模态和能量模态的表征和选择性治疗组织由2007年11月6日授权公告的Steinke等人的题为“Selectable Eccentric Remodeling and/or Ablation of AtheroscleroticMaterial”的美国专利7,291,146和在前引用的美国专利申请No.11/392,231、No.11/975,651、No.11/617,519、No.11/975,474、No.11/975,383、No.12/564,268公开,这些文献的全部公开内容通过引用并入本文。在最优选实施例中,功率输出为RF能,但是在前述文献中公开和描述的超声、激光、微波等也落在本发明的范围内。
现在参考图4,在一些实施例中,DDS块401、功率输出设定点控制409和峰值有效功率传感器块410包括现场可编程门阵列而不具有嵌入式处理器。在现场可编程门阵列包括内部处理器的其他实施例中,DDS块401、功率输出设定点控制409、峰值有效功率传感器块410和PID控制器可被包括在现场可编程门阵列内。
在一些实施例中,发生器和控制装置101可以包括处理器或者被耦接到处理器上以控制或记录治疗。处理器将典型地包括计算机硬件和/或软件,常常包括运行机器可读程序指令或编码以用于执行本文所述实施例和方法中的一个或多个中的一些或全部的一个或多个可编程处理器单元。编码将常常实施在有形介质例如存储器(可选地,只读存储器、随机存取存储器、非易失性存储器等)和/或记录介质(例如软盘、硬盘驱动器、CD、DVD、非易失性固态存储器卡等)中。编码和/或关联的数据和信号也可以经由网络连接(例如无线网络、以太网、因特网、内联网等)发送到处理器或从处理器中发送,并且编码的部分或全部也可以经由一根或多根总线在导管系统的部件之间和处理器内传送,并且在处理器中将常常包括适当的标准或专用的通信卡、连接器、电缆等。处理器也常被配置为至少部分地通过以软件编码对处理器进行编程来执行本文所述的计算和信号传输步骤,其中软件编码可以写为单个程序、一系列单独的子例程或相关的程序等。处理器可以包括标准或专用的数字和/或模拟信号处理硬件、软件和/或固件,并且可以优选地具有足够的处理能力以在患者治疗期间执行本文所述的计算,所述处理器可选地包括个人电脑、笔记本电脑、平板电脑、专用处理单元、或它们的组合。也可以包括与现代电脑系统相关联的标准或专用的输入装置(例如鼠标、键盘、触摸屏、操纵杆等)和输出装置(例如打印机、扬声器、显示器等),并且具有多个处理单元(或者甚至单独的电脑)的处理器可以在宽范围的集中式或分布式数据处理体系结构中采用。
在用于装置100的最优选实施例的控制软件中可以使用客户端-服务器方案以进一步增强系统的易用性、灵活性和可靠性。“客户端”为系统控制逻辑;“服务器”为控制硬件。通信管理器向订阅客户端和服务器发送系统条件的变化。客户端“知道”当前的系统条件如何、以及基于条件的具体变化执行什么命令或决定。服务器基于客户端命令执行系统功能。由于通信管理器为集中式信息管理器,因此新的系统硬件优选地可以不需要变化到现有的客户端-服务器关系;新的系统硬件及其相关的控制逻辑可以随后仅变为对通过通信管理器管理的信息的另外的“订阅者”。这种控制方案优选地提供具有鲁棒中央操作程序(具有固定的基础例程)的益处;优选地可能需要基础例程无变化,以操作设计为与系统一起操作的新电路部件。
用于组织治疗的配件
在一些实施例中,图1的总系统或装置100可以连同功率发生装置还包括附接配件,附接配件最优选地可以包括管腔内导管108,导管108具有包含在其中的能量输送表面。
在很多实施例中,能量输送表面可以优选地包括多个间隔开的电极112。如图1中所示的功率发生装置101通过连接器103操作性地耦接至多个电极,以便优选地容许所选电极的选择性赋能。
在很多实施例中,如图3A中所示,能量输送表面包括绕扩展球囊200布置的多个电极112,以便当球囊扩展为与组织例如管腔的组织相接触时在靶组织中限定多个改造区。
现在参见图1和图2,示出了在组织上诱导期望的温度效应的导管系统的一个示例性实施例。导管系统包括具有导管本体109的球囊导管108,该导管本体109具有近端部107和远端部111。导管本体109为柔性的且限定有导管轴线113,并且可以包括一个或多个管腔,例如导丝管腔206和扩张管腔201。若需要还可以设有其他管腔以用于其他治疗或应用,例如灌注、流体输送、成像等。导管108包括与远端部111相邻的可扩张球囊200和与近端部107相邻的壳体106。壳体106包括与导丝管腔206连通的第一连接器104和与扩张管腔201流体连通的第二连接器105。扩张管腔201在球囊200与第二连接器105之间延伸。第一连接器104和第二连接器105均可以可选地包括标准连接器,例如LUER-LOCTM连接器。远端顶端可以包括一体式顶端阀以容许导丝的通过等。
壳体106还可以容纳电连接器103,电连接器103可以优选地包括多个电连接,每个电连接均经由导体203电耦接至电极112。这种布置优选地容许电极112易于被赋能,电极经常通过包封的控制器和功率源101被赋能,控制器和功率源101可以优选地产生呈单极或双极RF能量、微波能量、超声能量的形式或其他合适的能量形式的能量。在一个这种实施例中,电连接器103耦接至图4的电路400,电路400在其最优选形式中可以产生RF能量,使得可以容许能量被选择性地引导到电极112上,正如图3B中所示。当采用单极RF能时,患者地可以例如通过外部电极或位于导管本体109上的电极提供。
现在参考图3B和图1,电极112优选地与周围组织300联接,使得能量可以在电极112A、112B、112C、112D与组织300之间传递,以便优选地启动生物反应。球囊200将典型地包括球囊导管108的远端部111,而位于球囊200上的能量输送表面例如电极112将一般地使用耦接到导管108的近端部107的能量源赋能。能量导管203可以沿着导管本体109在近端部107与球囊200之间延伸,而能量导管203常常包括用于施加RF能等等的电气导体、诸如沿着导管本体中的管腔布置以便传导激光或其他光能的光纤之类的光导体、或类似物。
如图3B中所示,电极112可以优选地周向围绕球囊200设置。能量301(最优选为RF能)可在最优选实施例中被引导到相邻对的电极112A和112C、或112A和112D、或电极112A-112D的任意组合上,从而治疗在周围组织300内的健康部分组织303和病变部分组织302。这种布置优选地创建能量路径301,能量路径301可以将具体治疗区域或部段中的能量或热量(“组织改造能量”)传递到介于电极对112A-112D之间的、具有体积为在电极对112A-112D之间的特定深度下的组织300(“改造区”)上。使用电极对112A-112D的不同组合可以通过使用重叠对而减小或消除在改造区之间的间隙。使用具有双极能量的电极对112A-112D优选地可以由此提供与单极方法相比时的改进性能。病变组织302已知为具有比健康组织302更高的电阻率。通过在双极系统中使用成对电极112(例如112A和112B),组织改造能量可以优选地通过健康组织303、病变组织302、或它们的组合,从而可以创建改造区。任意数量的电极112可以以不同的模式或阵列使用以创建任意数目的改造区。功率发生器和控制装置101可以施加恒定功率、恒定电压、恒定电流、或调制以产生恒定温度,只要其具有对组织类型和期望治疗反应的最大优势。
图2中更详细图示了球囊200。球囊200一般性地包括耦接到扩张管腔201上的近端部分202和耦接到导丝管腔206上的远端部分205。当使用流体或气体扩张时,球囊200径向扩展。在一些实施例中,球囊200可以为低压球囊,其被加压以与组织300相接触。在其他实施例中,球囊200可以为血管成形术球囊,其具有较高压力从而能够实现加热组织300且扩展组织300管腔两者。球囊200可以包括顺从性或非顺从性球囊,其具有折叠部以有利于将球囊从径向扩展的、扩张配置重新配置到低轮廓配置,尤其用于使用后的移除。
电极112安装在球囊200的表面上,而关联导体203从电极112近端地延伸。电极112可以以很多不同模式或阵列布置在球囊200上。该系统可以用于单极或双极能量应用。对于单极能量的输送,地电极可被使用在导管108轴上或患者的皮肤上,例如接地电极盘。对于双极能量的输送,相邻的电极112可以轴向偏移以容许双极能量在相邻的周向(轴向偏移)电极112之间引导。在其他实施例中,电极112可以布置在围绕球囊200的带中以容许双极能量在相邻的远端和近端电极112之间引导。
组织感测和治疗能量剂量的选择性输送
在很多实施例中,电极112可以被赋能以评估且随后选择性地治疗靶组织300、302、303以优选地实现治疗结果。例如,组织标记可以用来借助于阻抗测量识别组织治疗区域。利用在管腔内的周向间隔开的电极112(例如图3B中所示的那些)可以用来分析组织300、302、303。当电流路径通过病变组织302时且当其通过例如管腔壁的健康组织303时,在成对的相邻电极112之间(和/或在成对的分离电极112A-112D之间)的阻抗测量值可以有所不同。因此,在病变组织302的任一侧上的电极112之间的阻抗测量值可以指示损伤,而在其他成对的相邻电极112之间的测量值可能指示健康组织303。其他表征例如血管内超声、光学相干断层扫描等可以用来与阻抗测量值相结合或作为对阻抗测量的替代来识别待治疗区域。在某些实例中,由于组织标记和/或标记分布可能因人而异,可以期望优选地获得待治疗组织300、302、303的基线测量值以帮助区分相邻的组织。另外,组织标记和/或标记分布可以被归一化以有利于识别在不同组织之间的相关斜率、偏移等。在2006年10月18日提交的题为“Tuned RF Energyand Electrical Tissue Characterization For Selective Treatment OfTarget Tissues”的美国专利申请No.60/852,787、2007年4月4日提交的题为“Tuned RF Energy and Electrical Tissue CharacterizationFor Selective Treatment Of Target Tissues”的美国临时申请No.60/921,973中公开的任意技术可以与本发明相结合,这些申请的全部公开内容通过引用并入本文。
功率发生器和控制装置101可以被采用以在从约0.001瓦至约50瓦的范围内、在从约0.25瓦至5瓦的平均功率的优选示例范围内向电极112赋能约1秒至约180秒,或者赋能约4焦耳至约45焦耳。更高的能量治疗在更低功率且更长持续时间下进行,例如约0.5瓦约90秒或约0.25瓦约180秒。在2瓦至4瓦范围内的大多数治疗执行约1秒至约4秒。如果使用较宽的电极112间距,则优选的是扩展治疗的平均功率和持续时间,在这种情况下平均功率能够高于约5瓦,而总能量能够超过约45焦耳。类似地,如果使用较短或较小的电极对112A-112D,则优选的是降低平均功率,而总能量能够小于约4焦耳。功率和持续时间被校准以小到不足以导致严重的损害,并且最优选地,特别是小到不足以消融血管内的病变组织。
用于提供靶组织的期望加热和/或用于限制对旁系组织的加热的合适功率范围可以至少部分地取决于将能量施加到电极112(或其他能量传递表面)几何形状等上的时间。首先,当使用电极向组织施加本文所述的治疗时,在电路内可能存在对于组织的优选负载阻抗范围,以避免必须施加位于期望范围之外的电压和/或电流,特别是当施加在本文所述范围内的功率时。合适的负载阻抗范围将一般性地位于从约20欧姆至约4500欧姆的范围内,更典型地位于从约40欧姆至约2250欧姆的范围内,并且优选地位于从约50欧姆至约1000欧姆的范围内。
在电路内的组织的负载阻抗可以取决于组织的特性,并且也例如取决于与组织相接合的电极的几何形状,这是由于电极的几何形状和极性影响有效地包括在电路内的组织的几何形状。能量引导到其上的组织可以具有位于从约0.2西门子每米到约0.5西门子每米的范围内的特定电导率。不同类型的病变组织可以具有位于不同范围内的特定电导率,其中一些类型的病变组织具有范围从约0.2西门子每米至约0.5西门子每米的特定电导率,而其他类型则落在从约0.35西门子每米至约0.5西门子每米的范围内。
治疗的期望功率、能量和时间是类似相关的,并且也可以至少与电极112的几何形状相关。一般而言,施加长时间的较低功率治疗趋于得到具有较高总能量的治疗,而较短时间的较高功率治疗趋于得到较低能量的治疗。更具体地,在较低平均功率(1W或更少)下,每次治疗的总能量输送可以在从约8焦耳至约45焦耳的范围内。在较高功率(大于1W)下,每次治疗的总能量输送可以在从约4焦耳至约15焦耳的范围内。如果电极间距加倍,则功率可以增大四倍。传递到组织内的功率能够被校准且扩展到具体的电极配置,经常为了将功率和能量密度保持在期望的范围内。示例性功率范围可以例如从约1瓦至约5瓦。用于较低功率设定的持续时间典型地从约1秒至约8秒改变。小于约1瓦的很低功率设定也是可能的,从而使用比约10秒长很多的持续时间。
还可以通过改变电极112配置而大幅缩放功率设定。如果例如各电极112的内边缘至边缘的间距增大,则由于组织的体积变为约4倍大而可以施加约4倍的功率。由此,与本文所述的示例性实施例不同的电极配置能够在约4瓦至约20瓦的功率范围内使用。缩短电极112,并由此缩短和减小改造区的体积也会影响适于施加到组织体积上的功率的大小。
为了量化这组复杂的关系,并且约束示例性装置能够在其内进行操作的空间,可以图像化地、以表格形式、或通过数学关系生成并提供在这些参数中的若干参数的安全值之间的经验性关系。描述尤其有利的关系的示例性方程为:
功率=b x2Lt-0.59
其中,b为范围从0.2至0.6的参数,x为以毫米计的电极112的内边缘至边缘间距,L为以毫米计的电极112的长度(还是改造区的近似长度),功率以瓦计,而t为以秒计的时间。b具有(瓦/mm3)*(秒0.59)的单位。位于由该方程所述范围内的示例性治疗包括诸如4瓦2秒、3瓦3秒、2瓦4秒、和1瓦12秒之类的治疗。
电路400的校准可以通过在已知电路负载404处的三次测而执行,最优选地,阻抗ZρO在大约1000Ω的负载下获得,阻抗ZρS在约50Ω的负载下获得,而阻抗ZρL在约150Ω的负载下获得,其中在功率发生器和控制装置101处的复数电压和电流(图8的800V&I)测量值被用来计算阻抗ZρO、ZρS和ZρL。优选的校准方法可以容许在组织治疗之前和期间准确地实时测量阻抗,使得阻抗可以提供用于如本文公开和描述的组织表征和治疗控制的手段。
装置100的校准还可以包括识别附接到装置上的配件的步骤,所述识别通过重复校准以基于附接配件的阻抗特性确定其类型。例如,在附接配件包括导管108(还包括电极112)的图1中,存在的电极112的数目可以通过多路复用感测在导管108内的电极电路的数目(例如图2中所示的电极112和导体203)确定,其中导管108通过连接器103操作性地附接至功率发生器和控制装置102。再次参考图1、图4、图8和图16,在没有配件100'(典型地导管108)的情况下校准功率发生器电路400之后,导管能够附接到功率发生器电路1603上,并且能够再次对总装置100进行三次阻抗测量。
多个优点可以通过优选地自动再执行校准而获得。例如,通过使整个装置组件100而非单个子部件(例如电路400的各种元件)校准,在负载404处执行的阻抗测量可以保持用于组织表征和功率控制的准确指示而不管所附接的配件。另外,附接配件的感测配置可以对应于编程的治疗例程,使得电极112的各类配置的依赖性可以对应于在本文公开和描述的优选的持续时间和能量输送参数。更进一步地,附接配件的预编程识别防止不正确使用配件或使用不相容的配件。更进一步地,检测附接配件的类型的能力可以容许鲁棒且简单的配件识别方法,该方法避免与其他识别方法例如射频识别方法(其可能在灭菌期间劣化或与其他设备的操作相干扰)相关联的复杂性。此外,自识别方法可以减小或消除对用户命令的需求,从而提高易用性且最小化诸如在用户与装置之间的语言障碍之类的问题。另外,使用图形化用户界面102可以用作消除或减小语言依赖性并提升易用性的进一步的手段。
在很多实施例中,功率发生和控制装置101可以被编程以在功率输送靶404处测得的阻抗值的范围内进行操作,使得该系统可以在高于或低于设定极限时自动关闭。例如,装置101可以被编程以在从约5欧姆至约1000欧姆的负载阻抗的范围内进行操作,具有约50欧姆至约500欧姆的最优选范围,其中,所述范围的低端可能表示组织为健康的或响应于组织,而所述范围的高端可能表示组织的较差电接触或破坏。被编程的阻抗极限可以在避免将能量以超过所需剂量的方式不受控制地施加到各部位的方面提供进一步防护的优点。
图10-图13分别示出了在采用如由图1的装置组件控制和输送的温和加热的典型组织治疗时的电流、阻抗、电压、相位角和电极的功率响应。在图13中,在靶处测得的功率示出为与在生成器处的功率输出进行比较。
本文所述的血管治疗设备、系统和方法的实施例可以用来通过与温和或标准扩张相接合的温和加热来治疗动脉粥样硬化性疾病。例如,具有设置在其上的电极112的血管成形术球囊导管结构108可以在扩张之前、期间和/或之后向血管壁施加电势,可选地与扩张压力相结合,该扩张压力位于或显著地低于标准的、不加热的血管成形术扩张压力。当约10个大气压至约16个大气压的球囊200的扩张压力可以例如对于特定病变的标准血管成形术扩张为适当的时,本文所述的通过位于球囊200上的柔性电路电极112、203、直接沉积在球囊结构200上的电极112等与适当的电势相结合的修改的扩张治疗可以采用从约10个大气压至约16个大气压,或者可以实施为约6个大气压或更小的压力,并且可能低至约1个大气压至约2个大气压。这种中等扩张压力可与或不与组织表征、调谐能量、偏心治疗、和本文所述的用于治疗脉管疾病的其他治疗方面中的一个或多个方面相结合。
在很多实施例中,在血管扩张之前、期间和/或之后添加的温和加热能量可以提升扩张效力,同时降低并发症。在一些实施例中,使用球囊200的这种受控加热可以表现出再缠绕的减小,从而提供支架状扩展的益处中的至少一些而没有植入物的缺点。加热的益处可以通过限制低于有害响应阈值加热血管外膜层而被增强和/或抑制并发症。在很多情况下,血管内膜和/或介质的这种加热可以使用小于约10秒、通常小于约3(或甚至2)秒的加热时间而被提供。在其他情况下,很低的功率可以用于较长的持续时间。通过将电路的驱动电势匹配于靶组织的相位角而将能量301与靶组织300、302、303有效地耦接可以增强期望的加热效率,从而有效地最大化在电功率曲线下的面积。相位角的匹配不必是绝对的,但与表征靶组织匹配的完全相位匹配可能具有益处,替代系统可以预设定适当的电势以基本匹配典型的靶组织;尽管实际的相位角可能没有精确匹配,但是对靶组织内的局部加热却会比使用标准功率形式要好的多。
改造可能涉及能量施加到电极112上等,其中施加的能量最优选地呈RF形式,但也可以是微波和/或超声能量的形式。该能量将被控制以便限制靶组织和/或旁系组织的温度,例如,限制对易损斑块的纤维帽或动脉结构的内膜层的加热。
在一些实施例中,表面组织的温度范围为从约50℃至约90℃。对于温和加热,组织表面的温度可以范围从约50℃至约65℃,而对于更强的加热,表面组织的温度可以范围从约65℃至约90℃。限制对易损斑块的富脂类池的加热足以诱使脂类池的熔融,同时抑制加热其他组织例如内膜层或纤维帽到小于范围从约50℃至约65℃的组织表面温度,使得大块组织的温度大多保持为低于约50℃至约55℃可以抑制否则可能会导致再狭窄等的免疫反应。介于约50℃与约65℃之间的较温和的表面温度可能足以在治疗期间、在治疗之后立即、和/或在通过组织对治疗的愈合反应的治疗之后的多于一小时、多于一天、多于一星期、或者甚至多于一个月时使蛋白质键变性和断裂,以便提供更大的血管腔和改善的血液流动。
尽管本文所述的方法和装置没有在血管组织治疗中选取,但是装置100能够用于治疗同心和偏心动脉粥样硬化,这是由于动脉粥样硬化可以在50%的时间内、并且可能在高达(或甚至超过)75%的病例中关于血管的轴线偏心。
因此,动脉粥样硬化物质的改造可以包括动脉粥样硬化和其它斑块的收缩和熔融等。在动脉层内的动脉粥样硬化物质可被变性、熔融和/或治疗可以涉及动脉粥样硬化物质的收缩和/或生物活性剂在动脉层内的输送以改善血液流动。本发明还可以提供对于治疗易损斑块或血管(其中易损斑块为一个问题,其可能包括偏心病变)的特别优点。本发明也将发现用于温和加热帽结构以诱导帽的增厚且使斑块不那么易于破裂的应用和/或用于加热易损斑块的富脂类池以便改造、变性、熔融、收缩和/或重新分配富脂类池的应用。
能量的受控施加以实现基本均匀的大块温度
现在参见图14A-图15B,作为剂量的能量受控输送可以优选地用来通过能量的选择性分布式输送获得在大块组织中的基本均匀的温度分布。最优选地,组织可以在约50℃至约70℃的范围内被加热以获得优选地高到足以使蛋白质变性且促进愈合响应而同时避免可能在更高温度下引起的组织损伤的温度。组织温度的调节可以通过使用诸如热电偶、热敏电阻等之类的手段的直接温度测量而完成。但是,可能有利的是简化装置且优选地避免由于将导线或其他感测硬件包括到管腔内设备内而引起的设备轮廓的潜在增大。由于本发明具有输送准确能量剂量的能力以及测量在功率输送点处的阻抗的实时变化的能力,因此通过这些手段也能够获得基本均匀的温度分布。
在一个优选实施例中,组织阻抗可以用来推导组织温度条件。阻抗作为时间的函数的变化、或者阻抗斜率的微分(dz/dt)可以用来感测组织温度的变化。具体地,考虑到组织的导电率在组织冷却时减小,阻抗的增大表明组织的冷却。相反,考虑到组织的导电率在组织加热时增大,阻抗的减小表明组织的加热。由此,基本恒定的组织阻抗、或者约等于零的dz/dt可以用作通过感测在功率输送点处的阻抗获得基本均匀的温度分布的手段。
能量的分布式输送可以优选地被采用以进一步辅助获得大块温度的均匀性。例如,电极112A-L可以绕球囊的周缘分布。电极112A-L可以以两极模式通电,其中交替的电极对被通电,使得在能量的第一顺序施加中,每隔一个的电极对以分离的能量水平通电分离的时间段。在能量的第二顺序施加时,在能量的第一顺序施加时未通电的电极对被通电。可以经验性地确定电极对的功率配置和顺序以获得特定的温度,例如50℃、或60℃、或70℃。随后可以通过组织的阻抗测量来控制呈顺序剂量的形式的能量输送的持续时间以优选地维持大块组织中的基本均匀的温度。
尽管用于功率的任意时间、在通电之间的时间、在被通电电极之间的间距、以及所输送的总能量可以基于待加热组织的特定性质而被采用,但是图14A中所示的一个优选实施例示出了由以下步骤实现的基本均匀的温度分布:以约4瓦顺序通电每隔一个的电极对约1.5秒,随后以4瓦顺序通电先前未通电的电极约1秒。间隔的顺序通电的益处在于组织可以被自然地加热、保持、且开始冷却,使得在与没有选择性分布的情况下施加功率相比时,优选地避免了热量的高度集中。一旦初始功率剂量被输送,就可以施加另外的功率以作为调节的波谷组织阻抗测量。在图14B中所示的可选示例性实施例中,功率以与图14A所述相同的顺序方式输送,但在功率的第二顺序施加后继有约30秒的停顿,而功率的第二顺序施加的持续时间可以增大到约1.5秒。
在图15A-图15B中所示的另一示例性实施例中,使用累积剂量理论(例如通过Arrhenius方程所描述的)可以用来数字预测能量剂量,使得累积组织温度效应可以用来构建功率剂量例程。在每隔一个的电极对之间的约4瓦约5秒的第一顺序功率输送之后,可以是向先前未通电电极对的第二顺序功率输送,其中在第二顺序中针对每个电极对的功率水平和持续时间可以随位置改变,使得优选地计及组织的累积加热和冷却,由此可以获得基本均匀的温度分布。例如,电极对的按序第二通电顺序对于顺序中的第一电极对可以为约4瓦约0.45秒,对于顺序中的第二电极对可以为约2.6瓦约0.65秒,在第三对处为约1.8瓦约1.15秒,在第四对处为约1.5瓦约1.65秒,在第五对处为约1.3瓦约3.15秒,并且在第六对处为约1.1瓦约5秒。在该示例中,使用具有绕球囊的外周缘分布的12个电极的球囊,累积效应将优选地导致约60℃的组织温度。
使用累积损伤理论可以基于特征组织反应曲线而针对具体组织的类型而被裁剪,使得功率剂量例程可以被具体地开发用于获得特定组织类型中的特定温度。
另外,无论是否使用损伤累积模式或组织阻抗测量以维持基本均匀分布的大块组织温度,能量剂量均可以如本文前述地部分基于电极配置而改变。
施加能量以修改神经活性
在本发明的又一示例性实施例中,以靶剂量输送能量的能力可以用于神经组织以获得有益的生物反应。例如,慢性疼痛、泌尿功能障碍、高血压和多种其他持久性病症已知通过神经组织的操作而受影响。例如,已知慢性高血压(可能不响应于用药)可以通过禁用与肾动脉相近的过度的神经活性而被改进或消除。还已知神经组织不会自然地具有再生特性。由此,可能的是通过扰乱神经组织的传导路径而有益地影响过度的神经活性。当扰乱神经导电路径时,特别有利的是避免对邻近神经或器官组织的损坏。引导和控制能量剂量的能力特别适于治疗神经组织。无论是加热或消融能量剂量,如本文所述和公开的精确控制的能量输送可以被引导到神经组织。此外,能量的定向施加可足以靶向神经而不需要如在使用典型消融探头时所需的准确接触的需求。例如,偏心加热可以在温度高到足以使神经组织变性但不会导致消融且不需要穿透管腔组织的情况下被施加。但是,还优选的是将本发明的能量输送表面配置为刺透组织且输送扩张能量,类似于通过功率控制和发生装置101控制的具有准确能量剂量的扩张探头。
再次参考涉及减小过度神经活性的肾性高血压的示例,图3B可以用来描述非穿透性的、非消融方式以引导能量影响神经活性。神经组织可被定位为围绕肾动脉的管腔的组织300、302、302内的一些部位。球囊200上的电极112可以被通电以沿待影响的神经的已知方向输送能量301,能量穿透的深度为能量剂量的函数。此外,经验性分析可被用来确定神经组织的阻抗特性,使得装置101可以用来以如本文公开和描述的靶向方式首先表征且随后治疗组织。能量的输送和调节还可进一步涉及累积损伤建模。
尽管已经详细地描述了作为示例且为了清楚理解的示例性实施例,但是本领域的技术人员将认识到,可以采用多种修改、变型和变化。
Claims (55)
1.一种具有电路的用于治疗组织的功率发生装置,包括:
操作性地耦接至功率放大器的直接数字合成器(DDS);
提供信号的功率输出设定点控制器;
峰值有效功率传感器,所述峰值有效功率传感器接收在功率输送靶处测得的电压和电流反馈以测量在所述功率输送靶处的阻抗并且提供基于所述反馈的信号;以及
PID控制器,所述PID控制器操作性地耦接以接收来自功率输出设定点控制器和峰值有效功率传感器的信号,并且操作性地耦接以将调制电压信号引导到功率放大器,由此响应于在功率输送靶处测得的阻抗而使得来自所述电路的功率输出维持在功率输出设定点附近的范围内。
2.如权利要求1所述的功率发生装置,其中,数模转换器耦接在DDS与功率放大器之间。
3.如权利要求1所述的功率发生装置,其中,能量输出为RF能。
4.权利要求1所述的功率发生装置,其中,功率输送靶包括组织。
5.如权利要求1所述的功率发生装置,其中,DDS、功率输出设定点控制器和峰值有效功率传感器包括现场可编程门阵列。
6.如权利要求1所述的功率发生装置,其中,功率放大器包括操作性地串联耦接的可变增益放大器和线性功率放大器。
7.如权利要求6所述的功率发生装置,其中,功率放大器包括线性功率放大器,所述线性功率放大器的最大输出电压由在功率放大器中流过的电流控制。
8.如权利要求7所述的功率发生装置,其中,在使用期间从线性功率放大器向功率输送靶输出的电压包括RF输出电压,所述RF输出电压具有在约50欧姆至约500欧姆的负载阻抗的范围上的最大可用输出极值。
9.如权利要求7所述的功率发生装置,其中,来自线性功率放大器的最大输出电压限制功率放大器内的功耗。
10.如权利要求7所述的功率发生装置,其中,线性功率放大器使用开关模式技术控制最大输出电压。
11.如权利要求6所述的功率发生装置,其中,控制器包括PID控制器,并且其中,来自所述PID控制器的所述调制电压信号由可变增益放大器接收。
12.如权利要求1所述的功率发生装置,其中,峰值有效功率传感器包括DDS、电流电路和电压电路,其中所述电流电路还包括并联的平方根门和反正切门,而所述电压电路还包括并联的平方根门和反正切门。
13.如权利要求12所述的功率发生装置,其中,峰值有效功率传感器的DDS具有经低通滤波器的电压输出,以及经低通滤波器的电流输出。
14.如权利要求12所述的功率发生装置,其中,用于电流电路和电压电路的反正切门的输出操作性地耦接以通过余弦门。
15.如权利要求1所述的功率发生装置,其中,从功率输送靶向峰值有效功率传感器的所述电压和电流反馈各自包括同相和正交信号分量。
16.如权利要求1所述的功率发生装置,其中,来自峰值有效功率传感器的信号表示所述电路在功率输送靶处的有效功率输出。
17.如权利要求1所述的功率发生装置,其中,控制器包括PID控制器,所述PID控制器具有比例、积分和微分计算模块,这些模块接收来自峰值有效功率传感器和功率设定点控制器的信号,由此产生调制电压信号以在所述设定点附近的范围内调节所述电路的功率输出。
18.如权利要求1所述的功率发生装置,其中,功率输出设定点为约0.001瓦至约50瓦。
19.如权利要求1所述的功率发生装置,其中,功率输出在设定点附近以最大约±20%进行调制。
20.如权利要求1所述的功率发生装置,其中,功率输出在设定点附近以最大约±10%进行调制。
21.如权利要求1所述的功率发生装置,其中,功率输出在设定点附近以最大约±5%进行调制。
22.如权利要求1所述的功率发生装置,其中,功率输出在设定点附近以最大约±2%进行调制。
23.一种对用于治疗功率输送靶的装置进行校准的方法,所述方法包括:
测量在低第一电路负载下的电路阻抗;
测量在高第二电路负载下的电路阻抗;
测量在第三电路负载下的电路阻抗,所述第三电路负载介于所述第一电路负载与所述第二电路负载之间;以及
使用测得的阻抗以矢量网络分析计算所述装置的电路的系统阻抗,使得在功率发生期间的总电路负载阻抗的实时变化的测量代表在所述装置的功率输送靶处的阻抗的变化,其中基于在功率输送靶处的阻抗的实时测得的变化在功率输出设定点附近调制所述装置的功率输出。
24.如权利要求23所述的方法,还包括使用双向线性变换计算阻抗,用以进行功率校准和补偿。
25.如权利要求24所述的方法,其中,所述双向线性变换采用从一个或多个电路负载的测量值推导出的常数。
26.如权利要求23所述的方法,其中,一个或多个电路负载的测量值还用来补偿向功率输送靶输送的功率。
27.如权利要求23所述的方法,还包括识别附接到所述装置上的配件的步骤,所述识别通过重复校准步骤以基于附接配件的阻抗特征来确定所附接配件的类型。
28.如权利要求23所述的方法,其中,功率输送靶为组织。
29.如权利要求27所述的方法,其中,配件包括导管。
30.如权利要求29所述的方法,其中,导管还包括电极。
31.如权利要求30所述的方法,其中,存在的电极数量由位于附接至所述装置的所述导管内的电极电路的数量的复用感测来确定。
32.一种用于组织治疗的功率发生装置,包括:
操作性地耦接至RF功率放大器的DDS;
提供信号的RF功率输出设定点控制器;
峰值有效RF功率传感器,所述峰值有效RF功率传感器接收在RF功率输送靶处测得的电压和电流反馈以测量在RF功率输送靶处的阻抗并且提供基于所述反馈的信号;以及
控制器,所述控制器操作性地耦接以接收来自RF功率输出设定点控制器和峰值有效RF功率传感器的信号,并且操作性地耦接以将调制电压信号引导到RF功率放大器,由此响应于在RF功率输送靶处测得的阻抗而使得来自所述电路的RF功率输出维持在RF功率输出设定点附近的范围内。
33.一种用于偏心改造治疗在管腔周围的组织的功率发生和控制装置,所述装置包括:
操作性地耦接至RF功率放大器的DDS;
提供信号的RF功率输出设定点控制器;
峰值有效RF功率传感器,所述峰值有效RF功率传感器接收在所述组织处的电压和电流反馈以测量在所述管腔的周缘周围的阻抗,所述峰值有效RF功率传感器提供基于所述反馈的信号;以及
控制器,所述控制器操作性地耦接以接收来自RF功率输出设定点控制器和峰值有效RF功率传感器的信号,并且操作性地耦接以将调制电压信号引导到RF功率放大器,由此响应于在所述管腔的周缘周围测得的组织阻抗而使得来自所述电路的RF功率输出维持在RF功率输出设定点附近的治疗组织改造范围内。
34.如权利要求1所述的装置,其中,当在功率输送靶处测得的阻抗介于约50欧姆与约500欧姆之间时,系统操作软件限制功率发生的出现。
35.如权利要求1所述的装置,其中,在功率输送靶处测得的阻抗用来确定在功率输送靶处的电容和电阻。
36.一种用于计算峰值有效功率的方法,所述方法包括以下步骤:
计算未校正功率;
计算功率修正因子;以及
将所述未校正功率与所述功率校正因子相乘以获得所述峰值有效功率。
37.如权利要求36所述的方法,其中,所述计算未校正功率的步骤还包括计算电流幅度,计算电压幅度,并且将所得到的幅度相乘以获得所述未校正功率。
38.如权利要求36所述的方法,其中,所述计算所述功率校正因子的步骤还包括计算在同相与正交电压信号之间的相位角、计算在同相与正交电流信号之间的相位角、并且获得所述电压与电流相位角之差的余弦。
39.一种用于计算峰值有效功率的方法,所述方法包括以下步骤:
测量瞬时RF电压;
测量瞬时RF电流;以及
将所述RF电压乘以所述RF电流以获得峰值有效功率。
40.如权利要求39所述的方法,还包括将算出的峰值有效功率在一段时间上进行积分以获得平均RF功率的步骤。
41.一种用于将能量作为剂量进行受控输送以在组织中获得基本均匀的温度分布的方法,所述方法包括以下步骤:
将多个能量输送表面靠近所述组织布置;
通过以顺序方式将所述多个能量输送表面的第一部分通电而将能量剂量施加到所述组织上;以及
通过以顺序方式将所述多个能量输送表面的第二部分通电而将能量剂量施加到所述组织上。
42.如权利要求41所述的方法,还包括通过测量组织阻抗且施加能量来控制顺序的能量输送和组织的温度分布,使得测得的组织阻抗为大致恒定的。
43.如权利要求42所述的方法,其中,组织阻抗用来推断组织温度,所述组织温度与能量剂量经验性相关。
44.如权利要求41所述的方法,其中,顺序能量输送和组织温度分布的均匀性基于由累积损伤理论所确定的能量剂量。
45.如权利要求41所述的方法,其中,所述多个能量输送表面操作性地耦接至功率发生和控制装置,所述功率发生和控制装置还包括:操作性地耦接至功率放大器的DDS;功率输出设定点控制器,所述功率输出设定点控制器提供信号,在功率输送靶处测得的电压和电流反馈,用以测量在功率输送靶处的阻抗;峰值有效功率传感器,所述峰值有效功率传感器接收所述电压和电流反馈,提供基于所述反馈的信号;以及PID控制器,所述PID控制器操作性地耦接以接收来自电源输出端设定点控制器和峰值有效功率传感器的信号,并且操作性地耦接以将调制电压信号引导到功率放大器上,由此响应于在功率输送靶处测得的阻抗而使得来自所述电路的功率输出维持在功率输出设定点附近的范围内。
46.一种用于受控输送偏心靶能量以影响神经活性的方法,所述方法包括以下步骤:
将多个能量输送表面靠近其中含有神经的靶组织区域布置;以及
使用功率发生和控制装置将足以永久破坏靶组织区域中的神经信号传导的能量剂量施加到组织上,所述功率发生和控制装置具有:操作性地耦接至功率放大器的DDS;功率输出设定点控制器,所述功率输出设定点控制器提供信号、在功率输送靶处测得的电压和电流反馈,以用来测量在功率输送靶处的阻抗;峰值有效功率传感器,所述峰值有效功率传感器接收所述电压和电流反馈,提供基于所述反馈的信号;以及PID控制器,所述PID控制器操作性地耦接以接收来自功率输出端设定点控制器和峰值有效功率传感器的信号,并且操作性地耦接以将调制电压信号引导到功率放大器上,由此响应于在所述功率输送靶处的测量阻抗而使得来自所述电路的功率输出维持在功率输出设定点附近的范围内。
47.如权利要求45所述的方法,还包括:通过测量靠近所述多个能量输送表面的组织阻抗来表征神经位置并且基于对所述神经位置的靠近将所施加的能量引导到能量输送表面的选取部分上。
48.如权利要求45所述的方法,其中,永久破坏神经信号传导的能量剂量源于神经组织的传导性能的变性。
49.如权利要求45所述的方法,其中,永久破坏神经信号传导的能量剂量源于神经组织的消融。
50.一种用于治疗靶组织的功率发生装置,所述功率发生装置包括:
产生频率信号的频率合成器;
将频率合成器操作性地耦接至功率输出部的功率放大器,所述输出部可耦接至靶组织;
功率传感器,被配置为接收来自靶组织的电压和电流反馈且输出在靶组织处测得的阻抗;以及
控制器,所述控制器将功率传感器耦接至功率放大器,具有用于接收功率设定点的输入部,并且响应于功率设定点和在靶组织处测得的阻抗将调制信号发送给功率放大器,使得从功率放大器逐频率地向靶组织输出的功率被维持在功率设定点附近的范围内。
51.如权利要求50所述的功率发生装置,其中,所述频率合成器包括数字频率合成器,并且其中,数模转换器将所述频率合成器耦接至功率放大器。
52.如权利要求50所述的功率发生装置,其中,向所述靶输出的能量包括RF能。
53.一种RF系统,包括如权利要求50所述的功率发生装置,并且还包括具有细长柔性导管本体的细长导管,所述导管本体具有近端部和被配置为向血管内前进的远端部,连接器耦接到所述近端部并被配置为耦接至所述输出部,从而在使用时,所述导管将所述输出部耦接至与所述远端部相邻的靶组织,其中,测得的靶组织阻抗与功率发生装置和导管本体的阻抗无关。
54.一种在准备治疗靶组织时校准RF系统的校准模块,所述RF系统包括功率发生装置,所述功率发生装置包括阻抗测量电路,所述模块包括:
第一输入部,用于接收来自功率发生装置的阻抗测量电路的第一阻抗,所述第一阻抗对应于在将所述功率发生装置耦接至靶组织之前在所述功率发生装置上的低电路负载;
第二输入部,用于接收来自功率发生装置的阻抗测量电路的第二阻抗,所述第二阻抗对应于在将所述功率发生装置耦接至靶组织之前在所述功率发生装置上的高电路负载;
第三输入部,用于接收来自功率发生装置的阻抗测量电路的第三阻抗,所述第三阻抗对应于在将功率发生装置耦接至靶组织之前在所述功率发生装置上的中电路负载,所述中电路负载介于所述高负载与所述低负载之间;以及
处理器,被配置为使用测得的阻抗计算系统阻抗,以响应于在向靶组织施加功率期间对总电路负载阻抗中的实时变化的测量而促进在所述靶组织处的阻抗变化,所述总电路负载阻抗包括功率发生装置的阻抗和在靶组织处的阻抗。
55.如权利要求56所述的系统,其中,RF系统还包括用于将功率发生装置耦接至靶组织的导管,其中,所述处理器还被配置为在将所述导管耦接至所述功率发生装置之后且在将所述导管耦接至所述靶组织上之前计算所述功率发生装置和所述导管的另一系统阻抗。
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- 2011-04-11 CA CA2795229A patent/CA2795229A1/en not_active Abandoned
- 2011-04-11 WO PCT/US2011/000661 patent/WO2011126580A2/en active Application Filing
- 2011-04-11 AU AU2011238925A patent/AU2011238925B2/en not_active Ceased
- 2011-04-11 EP EP11766286.6A patent/EP2555699B1/en not_active Not-in-force
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WO2011126580A2 (en) | 2011-10-13 |
EP2555699B1 (en) | 2019-04-03 |
WO2011126580A3 (en) | 2012-01-05 |
AU2011238925B2 (en) | 2016-06-16 |
AU2011238925A1 (en) | 2012-11-01 |
US9277955B2 (en) | 2016-03-08 |
EP2555699A4 (en) | 2014-05-21 |
KR20130108067A (ko) | 2013-10-02 |
CN103068330B (zh) | 2016-06-29 |
US11071583B2 (en) | 2021-07-27 |
JP6302039B2 (ja) | 2018-03-28 |
JP2017074444A (ja) | 2017-04-20 |
EP2555699A2 (en) | 2013-02-13 |
CA2795229A1 (en) | 2011-10-13 |
US20120095461A1 (en) | 2012-04-19 |
JP2013523318A (ja) | 2013-06-17 |
US20160135883A1 (en) | 2016-05-19 |
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