CN100518685C - 组织消融设备 - Google Patents
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Abstract
本发明公开了一种组织消融方法和设备。该设备包括多个RF消融电极、和多个传感器元件,每个可在要消融的组织中从退回到展开位置运动。在设备中的一个控制器件可操作地连接到电极上,用来把RF功率供给到电极,以产生从个别电极消融区域前进以填充一个组合电极消融体积的组织消融。控制器件可操作地连接到用来确定在传感器元件的区域中的消融程度的传感器元件上。因而能调节RF功率到电极的供给,以控制贯穿组合电极体积的组织消融水平和程度。电极最好是空心针形电极,经其液体能注入到组织中,而且在控制单元的控制下,调制和优化组织消融。
Description
技术领域
本发明一般涉及一种用来治疗组织、组织块、组织肿瘤及损害的方法。更具体地说,本发明涉及一种用于肿瘤和组织块的最小介入治疗疗法的设备和方法。进一步具体地说,本发明涉及一种利用流体提高到肿瘤和组织块的能量输送以产生具有改进临床效果的较大、较快消融体积的设备和方法。
背景技术
使用RF能量来治疗肿瘤的当前方法具有几个关键缺点,包括不完全的消融体积、较小消融体积、组织干燥和炭化或延长的消融时间。本发明提供一种解决这些和其它相关问题的方法和设备。
发明内容
本发明提供了一种组织消融设备,包括:
(a)一个带有一个在远端终止的腔的细长输送器件;
(b)携带在所述器件中的多个电极,其中所述电极能够在退回位置和展开位置之间运动,且其中电极在器件的腔内布置于所述退回位置,所述的电极与电源可操作连接,以响应于电源提供给所述电极的能量产生组织消融,其中
(i)每个展开电极限定一个个别电极消融体积,当把一个RF电流初始施加到在组织中这样展开的该电极上时,该消融体积接近该电极,并且
(ii)对电极连续施加RF电流引起个别电极消融体积增长和彼此汇合以形成一个组合电极消融体积,
(c)携带在所述器件中的多个无源传感器元件,用来在退回位置和展开位置之间运动,其中传感器元件在器件的腔内布置于所述退回位置,而在所述展开位置,该传感器元件从所述远端在多个倾斜隔开位置处展开,且在所述多个倾斜隔开位置处,展开后的传感器元件分布在所述组合电极消融体积内,及
(d)位于每一无源传感器元件上以监测在所述组合电极消融体积中的组织消融的至少一个传感器,
其中供给所述电极的功率可以调节成根据由所述的传感器监测的组织消融在整个所述组合电极消融体积中控制组织消融的水平和程度。
本发明在一个方面包括一种组织消融设备,该设备包括:一个细长输送器件,带有一个在远端终止的腔;和多个电极,携带在器件中,用来在其处电极布置在器件的腔内的退回位置、与在其处电极从远端在多个弧形、横向延伸、倾斜隔开的位置处展开的展开位置之间运动。每个展开电极限定一个个别电极消融体积,当把一个RF电流施加到在组织中这样展开的该电极上时,该消融体积在消融的早期阶段接近该电极,其中包含的对电极的RF电流施加引起个别电极消融体积增长和彼此汇合以形成一个组合电极消融体积。
也在设备中的是携带在器件中的多个细长传感器元件,用来在其处传感器布置在器件的腔内的退回位置、与在其处传感器从远端在与组合电极消融体积相对应的体积内的多个倾斜隔开位置处展开的展开位置之间运动。
在设备中的一个控制器件或单元可操作地连接到电极上和连接到传感器元件上,用来:(i)把RF功率供给到在组织中这样展开的电极,以产生从个别电极消融体积前进以填充组合电极消融体积的组织消融;和(ii)确定在传感器元件的区域中的消融程度。因而能调节到电极的RF功率供给,以控制贯穿组合电极体积的组织消融的级和程度。
可以可选择地连接电极和传感器元件,用来作为一个单元从其退回到其展开位置运动。要不然,电极可以从其退回到其退回和展开位置运动,独立于传感器元件从其退回到展开位置的运动。
传感器元件处于其展开位置中,可以布置在个别电极消融体积外,最好在展开状态下的相邻电极对之间的中途。
在一个实施例中,传感器元件是导线,并且控制器件是可操作的以确定在导线区域中的组织的阻抗,作为在传感器元件的区域中消融程度的度量。
在另一个实施例中,传感器元件带有热传感器,并且控制器件是可操作的以确定在热传感器区域中的组织温度,作为在传感器元件的区域中消融程度的度量。
在又一个实施例中,传感器元件是光学纤维,并且控制器件是可操作的以确定在纤维的区域中的光学性能,作为在传感器元件的区域中消融程度的度量。
电极可以是空心针形电极,借助于在组织中这样展开的电极,允许液体经所述电极注射到组织中。一种示范液体是一种电解液,如一种生理盐溶液。在一个最佳实施例中,把电极设计成允许受控流体个别地流经每个电极。
每个注入电极可以沿其远端区域带有多个注入端口,并且可以由一个在其处分别覆盖和暴露注入端口的展开与注入位置之间轴向运动的护套覆盖。
控制单元可以包括:一个显示功能,用来向用户显示在传感器元件的区域中的消融程度;和一个可调节功能,如一个RF功率功能、或液体注入功能,借助于该功能用户通过调制功率级或注入到消融体积中的流体量能调节或调制消融的速率或程度。最好能把注入功能的功率控制在个别电极的级下,允许在消融过程期间控制个别电极体积的速率和程度。
要不然或另外,控制单元在消融过程期间可以自动控制到一个或多个电极的功率级和/或液体注入速率,以调制希望消融体积的个别区域的速率和/或程度,例如,以保证贯穿希望组合电极消融体积的消融的均匀速率和程度。在一个一般实施例中,电极在展开时靠近限定一个希望组合电极消融体积的一个虚拟的固体的表面中心定位。虚拟的固体的表面数量、和因此展开电极的数量例如由希望消融体积的大小确定。传感器元件在展开时可以靠近虚拟的固体的顶点定位。例如,为了消融限定一个棱锥的基本球形体积,设备可以具有在展开时靠近棱锥的表面中心定位的四个电极、和在展开时靠近棱锥顶点放置的四个传感器。
在另一个方面,本发明包括一种用来消融在病人中的选择组织体积的方法。该方法包括把一个组织消融设备插入到组织中,该设备带有:(a)一个细长输送器件,带有在远端终止的一个腔;和(b)多个空心针形电极,携带在器件中,用来在其处电极布置在器件的腔内的退回位置、与在其处电极从远端在多个弧形、横向延伸、倾斜隔开的位置处展开的展开位置之间运动。电极在其展开位置中限定要消融的选择组织体积。通过分别控制经每个空心针形电极的液体流动速率,把诸如电解液之类的液体经每个空心针形电极引入到组织中。把RF功率施加到电极上,以产生组织的RF消融。
液体可以经每个电极以基本相等的流量引入。可以选择具有希望电解液浓度的电解液。在RF消融步骤之前、期间、或之后可以引入液体。
该方法程度可以进一步包括在所述施加步骤期间监视在组织体积中的消融程度、和响应监视调节在其下液体经个别空心针形电极引入的速率,例如,以产生贯穿消融的组织体积的均匀消融速率和程度。
当联系附图阅读本发明的如下详细描述时,将更充分地明白本发明的这些和其它目的和特征。
附图说明
图1是立体图,表明用于肿瘤治疗的一种组织注入消融设备的一个实施例的放置和展开。
图2a和2b是立体图,表明包括带有多个注射器和多通道导管的注入器件配置的组织注入消融的关键元件。
图3是侧视图,表明机头和有关相联器件的各种元件。
图4是侧视图,表明带有一个可偏转导引器的图1或2的设备的一个实施例。
图5是侧视图,表明在导引器的远端处带有一个可偏转部分的图1或2的设备的一个实施例。
图6是侧视图,表明带有导引器的铰链附加可偏转部分的一个实施例。
图7a和7b是侧视图,表明带有在本发明方法的一个实施例中有用的可偏转导引器的设备的使用。
图8a-8j是剖视图,表明导引器和腔的各种横截面形状。
图9a-9h是侧视图,表明包括环形、球、半球、圆柱形、锥形和针形的电极的各种轮廓。
图10是侧视图,表明配置成穿入组织的一个针形电极的一个实施例。
图11是侧视图,表明具有至少一个曲率半径的针形电极。
图12是侧视图,表明带有一个腔和用于流体的输送和注入电解液的使用的孔径以产生一种增强电极的一种电极的一个实施例。
图13a是侧视图,表明具有在远端方向上运动的增大直径的孔径的一个电极或导引器的一个实施例,而图13b是图表,表示在向一个针端前进时孔径大小的变化。
图14a是侧视图,表明带有定位在一个力中性轴线上的一个或多个孔径的一个电极或导引器的一个实施例。
图14b是侧视图,表明带有定位在电极的相对横向侧上的孔径的一个电极的一个实施例。
图15a是侧视图,表明带有配置成把一种冷却流体提供给电极和周围组织的孔径的一个RF电极的一个实施例。
图15b是放大剖视图,表示来自不同形状喷嘴的注入液体的分布。
图16是侧视图,表明带有横向定位孔径(例如,侧孔)的电极的一个实施例。
图17是侧视图,表明带有一个非粘着涂层以减小由粘着和/或凝结组织的流体孔径的堵塞的电极的一个实施例。
图18a-18c是侧视图,表明带有一个配置成减小流体孔径堵塞的保护套的电极的一个实施例的使用。
图19是侧视图,表明带有配置成减小堵塞的倾斜角的电极的一个实施例。
图20a和20b是侧视图,表明带有多孔或编织远端部分的电极或套针的一个实施例。
图21是侧视图,表明本发明一种方法的一个实施例,其中经多个电极注入流体以创建聚结形成较大注入体积的注入区域。
图22a和22b是横向立体图,表明产生一个消融体积的多个注入电极的使用。
图23是立体图,表明带有一个或多个无源监视件和可定位在一个组织场合处的消融电极/有源件的一种组织注入消融的一个实施例。
图24是立体图,表明传感器在无源件上的定位和传感器对于监视源的联接的各种实施例。
图25是立体图,表明限定一个抽样体积的无源件的位置。
图26是立体图,表明限定由一个球形消融体积约束的一个四面体形抽样体积的有源电极的相对定位。
图27是立体图,表明带有这样配置的无源和有源阵列从而无源元件在有源元件/电极之间等距隔开的设备的一个实施例。
图28a-28c是立体图,表明套针的不同实施例,图28a表明带有锋利引导边缘的一种标准套针;图28b表明配置有一个引导内边缘的一种套针的一个实施例;及28c表明带有一个涂敷引导内边缘的一种套针的一个实施例。
图29是前视图,表明带有配置成防止无源件接触套针的锋利边缘和由其切割或擦伤的有源和无源件的包装布置的设备的一个实施例。
图30是侧视图,表明具有从绝缘到非绝缘套针部分的突然转变的套针的一个实施例。
图31是侧视图,表明带有台阶远端使一个直径配置成实现从绝缘到非绝缘套针部分的平稳转变的套针的一个实施例。
图32是侧视图,表明带有一个放射部分的能量输送器件的一个实施例和其在本发明一种方法的一个实施例中的使用。
图33是侧视图,表明光线治疗剂在本发明一种方法的一个实施例中的使用。
图34是方块图,表明本发明包括的一个控制器、能量源和其它电子元件。
图35是方块图,表明与本发明一起使用的一个模拟放大器、模拟乘法器和微处理器。
图36是立体图,表明优化在本发明方法中的消融体积的虚拟的固体的使用。
图37a-37e是立体图,表明适用于图36的实施例的各种虚拟的固体。
具体实施方式
本发明的实施例提供通过利用导电性增强溶液输送消融电磁能量以产生比通过常规手段快、大和一致的消融体积而治疗肿瘤和损害的一种方法和设备的好处。然而,在经一个空心管或空心电极注入流体时潜在问题之一是,当把电极插入到组织中时电极流体腔的堵塞、或在能量输送期间由电极加热生成的组织凝结或两者的组合。本发明的另外实施例提供对于在电极插入到组织中期间或在消融能量输送期间电极和注入腔的组织堵塞出现的问题提供多种解决方案。
治疗肿瘤和损害的一种组织注入消融设备10的一个实施例表示在图1中。设备配置成定位在一个骨组织部位5’以治疗或消融肿瘤或损害5″。组织部位5’能布置在包括但不限于肝、骨、胸、脑和腿的各种组织中的任何位置中。设备能配置成处理多种损害和骨病,包括但不限于转移性损害、溶骨损害、成骨细胞损害、肿瘤、骨折、感染部位、发炎部分等。一旦定位在目标组织部位5’处,设备10就能配置成治疗和消融在该部位的组织以及使用在这里描述或在先有技术中已知的一个骨组织检查器件收集一个组织样本。
现在参照图2,一种组织注入消融设备10的一个实施例包括带有一个近端14、一个远端16、及在其之间延伸或至少穿过远端区域的一部分的一个内部腔的一个细长件或长柄12。远端16可以足够锋利以穿入包括骨、软骨、肌肉和纤维和/或包围肿瘤块中。在一个实施例中,远端16能是整体的或否则通过在先有技术中已知的接合手段,如粘合剂粘结、钎焊、RF焊接、卷曲等,联接到导引器12上的一个针。柄12可以带有可以延伸过其长度的全部或一部分的一个或多个腔13。一个能量输送器件,一般指示为18,联接到远端16’上。能量输送器件18能配置成联接到一个能量或电源20上。一个传感器22可以联接到包括远端16’和能量输送器件18的长柄12上。
为了讨论容易,长柄12现在称作导引器或输送器件12,但这里讨论的所有其它实施例同样适用。现在参照图1-4,在各种实施例中,导引器12在其近端14处也能联接到一个手把或机头24上。长柄或导引器这里也称作一个细长输送器件。机头24的全部或部分能是可拆除的,并且能包括端口24’和执行器24″。端口24’能联接到一个或多个腔13上,并且能包括流体和气体端口/连接器及电气、光学连接器。在各种实施例中,端口24’能配置成用于吸气(包括组织的吸气)、和冷却导电性增强、电解液、冲洗、聚合物和这里描述的其它流体(液体和气体)的输送。端口24’能包括但不限于luer配件、阀(单路、双路)、toughy-bourst连接器、锻接变径配件、及在先有技术中已知的其它适配器和医疗配件。端口24’也能包括lemo-连接器、计算机连接器(串行、并行、DIN等)、微连接器及对于熟悉本专业的技术人员熟知的其它电气变形。
而且,端口24’能包括允许光学纤维和/或观察镜(如正象计)光学和电子联接到照明源、目镜、视频监视器等上的光电连接。执行器24″能包括摇臂开关、枢轴杆、按钮、旋钮、棘轮、凸轮、齿条和小齿轮机构、杠杆、滑块及在先有技术中已知的其它机械执行器。其全部或部分能加入。这些执行器能配置成机械、机电、或光学地联接到拉线、偏转机构等上,允许导引器12的选择性控制和转向。机头24通过端口24’的使用能联接到组织吸气/收集器件26、流体输送器件28(例如注入泵)、流体箱(冷却、电解液、冲洗等)30或电源20上。组织吸气/收集器件26能包括注射器、联接到一个过滤器上的真空源或收集腔室/襄。流体输送器件28能包括医疗注入泵、Harvard泵、蠕动泵、注射泵、注射器等。
再参照图2,在各种实施例中,流体输送器件能是配置有多个注射器28s、使每个注射器直接或经诸如一个加入阀28i之类的阀联接到一个分离流体腔或通道72上的多孔注射器28b的一个注射泵。注入器件28的相关实施例能包括一个加入阀28i以及经腔13或在导引器12内的其它通道连接到一个或多个腔72上的多腔管或多通道管72b(它能由PEBAX、硅酮或其它弹性聚合物制造)。
在各种实施例中,包含导引器12和远端16的组织注入消融设备10的至少各部分可以足以不透射线以在荧光检查等下可见和/或足以产生回波(echogenic)以使用超声波探测可见。在特定的实施例中,导引器12在包括沿包括远端16’的导引器12的全部或各部分的选择位置处能包括不透射线、不透磁(magnopaque)或产生回波的标记11。标记11能沿导引器12布置便于包括组织收集部分、端口、传感器以及这里描述的组织注入消融设备10的其它元件和部分的组织透入部分16的辨别和定位。在一个实施例中,标记11能是在先有技术中已知的超声波发射器。而且组织注入消融设备10能包括成像能力,包括但不限于光学纤维、诸如正象计之类的观察镜、扩展目镜、视频成像器件、超声波成像器件等。
在各种实施例中,设备10能配置成通过一个套针、活组织检查器件、或在先有技术中已知的正象计或其它经皮或外科进入器械经皮引入到组织中。对于这些器件的任一种,借助于导引器12配置成跟踪的一根导向金属丝15能引导设备10。导向金属丝15能是在先有技术中已知的各种可弯曲和/或可转向导向金属丝或皮下管的任一种。导引器12能具有足够的长度,以便使用皮下或支气管/经口方法把远端16’定位在骨5的任何部分或叶中。导引器12的长度能在从5至180cm的范围内,特定实施例具有20、40、80、100、120和140cm。一个最佳范围包括25至60cm。导引器12的长度和其它尺寸方面也能配置成用于儿科用途,在这些实施例中一个最佳范围具有15至40cm。导引器12的直径能在从0.020至0.5英寸的范围内,特定实施例具有0.05、0.1和0.3英寸以及像在先有技术中已知的1、3、6、8和10弗伦奇尺寸。同样,借助于1、3和6弗伦奇的儿科尺寸,能把直径配置成用于儿科用途。在各种实施例中,远端16的直径能在从0.010至0.1英寸的范围内,特定实施例具有0.020、.030和.040英寸。远端16’的直径能配置成定位在各种解剖导管、脉管系统和细支气管中,这样的实施例包括0.40″或更小的直径。
在各种实施例中,导引器12能是一根导液管、多腔导液管、或一个金属丝增强或金属编织聚合物长柄、端口器件(如由 Corp.,Redwood City,CA制造的那些)、皮下端口或对于熟悉本专业的技术人员知道的其它医疗引入器件。在一个特定实施例中,导引器12是一个套针或一个安全套针等。导引器12能由在先有技术中已知的各种金属等级金属构造,包括诸如304或304V不锈钢之类的不锈钢以及诸如Nitino之类的形状记忆金属。导引器12也能由诸如聚碳酸酯或ABS或弹性聚合物之类的刚性聚合物构造,包括Pebax、聚氨基甲酸酯、硅酮HDPE、LDPE、聚酯及其组合。
在各种实施例中,导引器12能是刚性的、半刚性的、柔软的、弧形的及可控的,并且能包含光学纤维(包括照明和成像纤维)、流体和气体通路、及传感器和电子布线。在一个实施例中,导引器12是足够刚硬的(例如具有足够的柱强度),以便刺入包括骨组织的组织中而没有沿其纵向轴线的显著偏转,从而在一个组织部位内保持一个纵向或其它位置。在另一个实施例中,导引器12的全部或各部分(例如末端部分)柔软得足以刺入组织,并且在任何希望方向上穿过组织到一个希望组织部位5’。在又一个实施例中,导引器12足够柔软以颠倒其行驶方向并且在从本身返回的方向上运动。
现在参照图3和4,在其它实施例中,导引器12的全部或各部分能配置成使用能包括拉线、棘轮、门闩和锁定机构、压电材料及在先有技术中已知的其它偏转装置的偏转机构25可偏转和/或可转向的。偏转机构25能联接到在机头24上的一个可动或可滑动执行器25’上或与其成为整体。机构25和联接的执行器25’配置成允许医师选择性地控制远端16’的偏转量25″或导引器12的其它部分。执行器25’能配置成通过执行器的转动和纵向运动的组合即转动又偏转远端16。在一个最佳实施例中,偏转机构25包括联接到在这里描述的机头24上的一个执行器24’上的一根拉线。
导引器12的偏转量是可选择的,并且能配置成允许导引器12通过非常曲折的解剖的操纵和越过绕包括脉管系统、导管和骨的各种和解剖结构的钝角或倾斜向内弯。在特定实施例中,导引器12的远端部分能配置成在高达三个轴线中偏转0-180°或更多,以允许导引器12的末端具有后退定位能力。使用一个指明执行器25’偏转能是连续的或指明到在机头24上可选择的预定量。
现在参照图5、6(带有靠近导引器远端的可偏转部分12d的一个实施例的侧视图)和(表示一个铰链附加可偏转部分的侧视图),在一个特定实施例中,导引器12在其远端部分16处或靠近其带有一个可偏转或铰接部分12d。可偏转部分12d能通过使用波纹或柔软材料(例如,具有比导引器的接合较不柔软部分低的硬度的材料)卷边、切断、模压、或在先有技术中已知的其它聚合物金属加工或导液管处理方法。可偏转部分12d能通过包括联接到穿过导引器的腔13前进和后退的一根拉线或一个加强心轴上的拉线、棘轮机构、一个凸轮机构、一个齿轮机构(包括齿条和小齿轮或蜗轮机构)的多个装置偏转。可偏转部分12d使用一个包括由一根拉线或加强心轴15铰接的一个或多个铰链部分12h的一种铰链机构也能铰链或枢轴固定到导引器12上。部分12h能使用在先有技术中已知的一个或多个铰链或枢轴接合12j机械联接到导引器12上和彼此联接。
参照图7a和7b(表明可偏转部分12d的使用的立体图)。在使用中,可偏转部分12d允许导引器引入到在一个第一固定位置中的组织部位5’(相对于导引器的纵向轴线12al最好是直的),并且然后向一个第二位置偏转一个可选择量,从而便于一个或多个能量输送器件18展开到肿瘤块5″或组织部位5’中。而且,可偏转部分12d允许能量输送器件相对于导引器的纵向轴线12al以一个可选择角度(包括从锐角到钝角的范围)展开。这些能力提供几个好处,包括(i)保证能量输送器件到选择肿瘤块中的一种更完全展开;(ii)允许能量输送器件减小过程时间的较快展开和退回;(iii)允许能量输送器件18定位和展开在一个不规则形状的肿瘤块(例如,长方形、椭圆)中;(iv)允许设备和能量输送器件弯曲定位和展开,否则难以到达包括矫形解剖的解剖部分;及(v)允许设备和能量输送器件在靠近或相邻一个易损或敏感解剖结构(例如脊髓、动脉)的肿瘤部位处展开,具有降低损伤该结构的危险否则具有不适当的危险。在可选择实施例中,可偏转部分12d也能用来把这里描述的注入流体(包括一股或一束流体)的输送指向组织部位5’或肿瘤块5″的一个可选择部分。
在另一个实施例中,导引器12能包括允许电极18以相对于导引器12的纵向轴线12al的可选择角度展开,包括约45和90°。这样的侧端口的使用在美国专利No.5,683,384中描述,该专利通过参考包括在这里。
参照图8,导引器12能具有一个基本上圆形、半圆、椭圆或月牙形横截面、以及其沿其长度的组合。类似地,腔13对于导引器12的长度12″的全部或一部分能具有一个圆形、半圆、椭圆或月牙形横截面。
各种能量输送器件和电源能由本发明的实施例利用。在一个或多个实施例中能采用的特定能量输送器件18和电源20包括,但不限于如下:(i)联接到提供在从约915MHz到约2.45GHz频率范围内的微波能量的一根微波天线上的一个微波电源,(ii)联接到一个RF电极上的一个射频(RF)电源,(iii)联接到一根光学纤维或光导管上的一个相干光源,(iv)联接到一根光学纤维上的一个不相干光源,(v)联接到带有配置成接收加热流体的一个封闭或至少部分打开腔的一个导液管上的一种加热流体,(vi)联接到带有配置成接收冷却流体的一个封闭或至少部分打开腔的一个导液管上的一种冷却流体,(viii)一种低温流体,(ix)联接到一根导线上的一个电阻性加热源,(x)联接到一个超声波发射器上的一个超声波电源,其中超声波电源产生在约300KHZ到约3GHz范围内的超声波能量,(xi)及其组合。
为了对于本申请的剩余部分讨论容易,能量输送器件包括多个RF电极18,并且利用的电源是一个RF电源。对于这些和有关实施例,RF电源把5至200瓦特、希望5至100、及更希望5至50瓦特的电磁能量不妨碍地输送到能量输送器件18的电极。电极18电气联接到能量源20上。该联接能从能量源20分别指向每个电极18,或者间接地通过使用把一个或多个电极联接到能量源20上的一个夹套、套筒、连接器、电缆等。输送能量能在1至100,000焦耳的范围内,希望在100至50000焦耳的范围内,更希望在100至5000焦耳的范围内,及最希望在100至1000焦耳的范围内。对于诸如神经和小肿瘤之类的较小结构的消融能输送较低量的能量,对于较大肿瘤用较高量的能量。也能修改输送的能量(借助于信号调制和频率)以消融或凝结血管化肿瘤的血管。这提供这样的好处:提供损坏而否则阻塞肿瘤的血液供给的高度保证。
现在转到RF电极的构造和配置的讨论,在各种实施例中,电极18能由各种金属和非金属的传导材料制成。用于电极18的适当材料包括诸如皮下质量的304不锈钢之类的钢、铂、金、银和合金及其组合。而且,电极18能由诸如圆的、平的、三角形的、矩形的、六角形、椭圆的等之类的各种形状的传导固体或空心直导线制成。在一个特定实施例中,电极18的全部或部分能由可从RaychemCorporation,Menlo Park,California买到的诸如NiTi之类的一种形状记忆金属制成。
再参照图1-2,多个电极18携带在器件中,用来在其处电极布置在器件的腔内的退回位置、与在其处从远端最好在多个弧形、横向延伸、倾斜隔开位置处展开电极的展开位置之间运动,特别是如在图2和22-24中表明的那样。弧形是指电极以具有一个多个曲率半径的弯曲形式从器件远端成扇状离开。横向延伸是指在其展开位置中的电极径向向外远离器件远端延伸。倾斜隔开是指电极在从在图23中的顶部看时以典型在20-120度之间的角度彼此隔形,这取决于在电极组中的电极数量。如在下面将讨论的那样,每个展开电极限定一个个别电极消融体积,如一个球形体积,在把一个RF电流施加到该电极上时该体积靠近该电极,使在组织中这样展开。也如在下面将讨论的那样,对于电极的RF电流(它可以作为功率测量)的连续施加的场合引起个别电极消融体积增长和彼此汇合,以形成一个组合电极消融体积。
电极在其近端处典型地聚束在一起,用来作为一个单元在退回与展开位置(这能包括部分展开位置)之间运动。一个手把或其它执行器装在该器件上或者否则与其一起起作用,以允许用户把电极从其退回位置运动到各种展开(部分或完全展开)位置。这样的电极构造是已知的。
诸如电极18之类的电极能包括一个或多个联接传感器22,以测量温度和阻抗(电极和周围组织的)、电压和电流、及电极和相邻组织的其它物理性能。传感器22能定位在电极18的外部或内部表面上,在其远端或中间截面处。为了目测目的,能把一个不透射线的标记11附加、钎焊或涂敷在电极18上。
现在参照图9-11,在各种实施例中,电极18能具有各种形状和几何外形,包括但不限于环状、球、半球、圆柱、锥或针状,如在图9中表明的那样。在图10中表示的一个实施例中,电极18能是一根足够锋利的针,以刺入包括骨、软骨和纤维组织及封闭肿瘤的组织中。电极18的远端能具有范围从1到60°的一个切角68,希望范围至少25°或至少30°,及特定实施例是25°和30°。表面电极18能是平滑的或具有某种结构及凹下或凸起的。电极18的传导表面面积38’能在从0.05mm2至100cm2的范围内。参照图11,电极18也能配置成可弯曲和/或可偏转的,具有能超过180°弯曲的一个或多个曲率半径70。在使用中,电极18能配置和定位成加热、坏死或消融任何选择的目标组织体积5’。
电极18能具有从导引器12的远端前进的可选择长度38。各长度能由电极18的实际物理长度、电极18的能量输送表面38’的长度及由一个绝缘体覆盖的电极18的长度38″确定。适当的长度38包括但不限于从1至30cm的范围,特定实施例是0.5、1、3、5、10、15和25.0cm。电极18的实际长度取决于要消融的组织部位5’的位置、其离部位的距离、其可达性以及医师是否选择内镜、皮下、外科或其它过程。
现在参照图12,在各种实施例中,电极18能包括联接到多个流体分布端口23或孔径23上的一个或多个腔72(它能与腔13连接或与其相同)。流体分布端口23能绕电极18的全部或只一部分均匀地形成,并且配置成允许流体27的引入或注入到一个选择组织部位,也到电极表面。这能通过使端口23流体联接到腔13(经腔72或流体通道)上实现,腔13又流体联接到流体箱30和/流体输送器件28上。端口23能配置成以低流量和雷诺数(例如,慢吸)到高流量a(例如,喷射)和其之间的值以及具有包括但不限于1至100厘泊粘度范围的低和高粘度流体输送流体,特定实施例具有1、3、5、10和20厘泊。这能通过控制直径23d、在一个或多个电极23上端口23的数量和位置实现。
经端口23能注入或引入的适当流体27包括但不限于液体、软膏、凝胶乳化液、传导性增强流体、电解溶液、盐溶液、冷却液、低温流体、气体、化疗剂、药剂、基因治疗剂、光疗剂、造影剂、注入介质及其组合。适当传导凝胶的例子是由诸如生理盐溶液之类的含水电解溶液等制成。
在各种实施例中,端口23的尺寸和直径能依赖于其在电极上的位置以及电极的尺寸和形状变化。最好定位孔径23的至少一部分,并且甚至更希望靠近电极18的远端18de集中。在各种实施例中,1至10侧孔径23靠近远端18de定位,特定实施例具有2、3和五个孔径。这些和相关配置允许在其中在电极周围的电流密度最大的位置处传导性增强溶液27的注入,允许电极和相邻电极的组织携带增大的电流密度,而没有引起电源20的阻抗断路的干燥、炭化和显著的阻抗升高。孔径23也配置成湿润电极18的表面18s(如在这里更充分地描述的那样),以便冷却它、增大传导性和防止组织粘结和炭化。
在图13中表示的一个实施例中,端口23能配置成具有在远离方向上运动的增大直径23d,从而保持从每个端口23出来的流量近似恒定和/或防止归因于压力减小的显著减小。增大直径对于距离的关系能是线性的、抛物线的或对数的。在一个最佳实施例中,把孔径23配置成具有相对于电极18o在远离方向上前进的增大直径,以便根泊肃叶定律(F=DP pr 4/8hl)通过减小在远离方向上运动的流体阻力提供在电极的开孔径部分18ap上的基本恒定流量。这通过增大孔径直径23d约孔径放置横向距离的增大的0.0625%(例如,约1:16比率)实现。
现在参照图14a,在另一个有关实施例中,孔径23的全部或一部分基本上定位在一个或多个电极18的中性力轴线18nfa上。在这些和相关实施例中,电极18能配置成可弯曲和/或可偏转的。这能通过用于电极的材料性质的选择以及其构造和这里描述的一个偏转机构的使用实现。电极18的适当可弯曲实施例包括由弹簧钢、304不锈钢、形状记忆金属、镍钛合金(NITINOL)、铰接金属、柔软金属丝、0.018柔软金属丝、高强度聚合物等构造的电极。沿力中性轴线18nfa定位孔径23提供能全向偏转或弯曲的一种电极的好处,而没有结构完整性的显著损失,并因而降低失效的可能性。在电极中孔径23注入孔的使用也提供停止裂纹扩展的好处。
在这些和相关实施例中,使用在先有技术中已知的激光钻孔或微加工或钻孔技术。由使用在先有技术中已知的机械工程方法计算的、或实时使用包括但不限于在先有技术中已知的光弹光学方法的分析光学技术,包括但不限于莫阿干涉测量法、数字斑点图案干涉测量法(DSPI)及细栅格技术的计算机分析,辨别的电极18的几何中心线,能确定力中性轴线18nfa的位置。在一个实施例中,能钻削孔径23,同时进行应力或应变线的光学测量,以得到孔径沿电极的力中性轴线的更准确放置。在这些和相关实施例中,通过在先有技术中已知的一个或多个夹具的使用能便于孔径23的钻削。
在图14b中表示的相关实施例中,孔径23也能定位在电极18的相对横向侧18ls上并且偏移一个距离23ad,以保留电极的结构完整性,同时降低在电极两侧上堵塞的可能性。在一个特定实施例中,一个孔径能定位成离电极远端18de 4mm,而第二孔径能定位在离电极远端18de的距离6mm处的电极的相对侧上。
在图15中表示的一个实施例中,孔径23能配置成提供一个或多个电极18和周围组织的冷却,以防止组织由于炭化组织在电极18的表面上的附着在电极18处产生过大阻抗。冷却通过借助于对流、传导及其组合冷却电极的一种冷却溶液的使用完成。冷却量能通过如下参数的一个或多个的控制而控制:(i)冷却溶液的温度(ii)冷却溶液的加热能力(例如,比热)。冷却溶液的例子包括水、盐溶液、和乙醇及其组合。其它实施例能利用用来通过蒸发式冷却或Joule Thomson效应冷却以及上述机构冷却电极18的一种冷却流体或气体27g。利用Joule Thomson效应冷却的实施例能具有一个喷嘴形孔径23n以提供冷却流体27g的膨胀。冷却流体27g的例子包括但不限于氟利昂、CO2、和液氮。
现在参照图12和15,各种实施例设备能配置成把传导性增强溶液27或其它溶液注入或输送到包括组织块5″的目标组织部位5’中。溶液能在通过能量输送器件把能量输送到组织部位之前、期间或之后注入。一种传导性增强溶液27到目标组织5’中的注入创建一个具有增大导电性(相对于未注入组织)的一个注入组织区域5i,从而作为一个增强电极40。在RF能量输送期间,在增强电极40中的电流密度大大地降低,允许把较大量的RF功率输送到电极40和目标组织5’中而没有阻抗失效。在使用中,用传导性增强溶液注入目标组织部位提供两个重要好处:(i)较快的消融时间;和(ii)较大损害的创建;两者都没有RF电源的阻抗相关断路。这归因于这样的事实:传导性增强溶液减小电流密度,并且防止否则导致组织阻抗增大的相邻电极的组织的干燥。传导性增强溶液的一个例子包括盐溶液,包括低张或高张溶液。其它例子包括卤化物盐溶液、和胶态铁溶液和胶态银溶液。增强电极40的传导性能通过注入速率和量的控制和具有较大电解液浓度(例如,盐)并因此具有较大传导性的溶液的使用增大。
在各种实施例中,传导性增强溶液27的使用允许把高达2000瓦特的功率输送到阻抗断路的组织部位,特定实施通过改变注入溶液27的流动、量和浓度实现50、100、150、250、500、1000和1500瓦特。溶液27的注入能是连续的、脉冲的或其组合,并且能由这里描述的一个反馈控制系统控制。在一个特定实施例中,在能量输送之前输送一团注入溶液27,接着是在借助于能量输送器件18或其它装置的能量输送之前或期间开始的连续输送。在另一个实施例中,使用反馈控制,以便通过监视在电极-组织界面处的阻抗和响应阻抗增大使用PID或在先有技术中已知的其它控制算法增加冷却和/或传导流体27的流量防止阻抗升高和失效。在相关实施例中,反馈控制也能包括对于一个或多个电极的展开长度(例如,展开深度)的传感器输入,并且把这并入到一种算法中,以调节在这里描述的流体流动、能量输送功率级、工作循环、持续时段和其它消融相关参数。
在相关实施例中,肿瘤块5’的传导性能增强,从而最好相对于健康组织增大到肿瘤块5’的能量输送速率和能量总量。这能通过经仅放置在肿瘤块内的一个针状电极18的使用把溶液27直接注入到肿瘤块5’中实现。在相关实施例中,注入溶液27能配置成保持或最好吸收,否则由肿瘤块5″吸收。这能通过控制溶液的渗透性、粘度和浓度的一个或多个实现。
利用一种传导性增强溶液27的注入的本发明实施例提供几种重要的好处,包括更一致和均匀的消融体积以及更快的消融时间。这通过把传导性增强溶液27注入到希望消融体积或目标组织部位中实现,以便增大和均匀化贯穿希望消融体积的组织传导性。这又显著降低组织干燥、炭化以及较高阻抗尺寸区的发生,这些的任一种能减缓或防止消融RF或热能的输送。
现在参照图16,在各种实施例中,注入端口23的全部或一部分能配置成,在电极18的壁18w中的侧孔偏离电极18的远端18de一个最小纵向距离231d。这些和其它实施例通过足够靠近的位置孔径23从而它不会由组织塞23tp堵塞,解决当电极前进到组织中时可能发生的组织堵塞或阻塞流体输送腔72的问题。远端18de能包括一个轴向孔径23de,或者在一个最佳实施例中不消除电极的任何组织成芯效果。在各种实施例中,距离23ld能在0.010至1英寸的范围内,较希望0.05至0.5英寸及更希望0.1至0.25英寸。特定实施例能包括0.05、0.1、0.15和0.16英寸。
在图17中表示的一个实施例中,通过定位在包括内腔72的电极18的表面18s的全部或一部分上的一个光滑或非粘着涂层18c的使用能克服组织堵塞。涂层18c防止组织,包括烧伤或炭化组织和其它生物材料,凝结、附着或否则粘着到电极表面18s、孔径23或内腔72上。在特定实施例中,把涂层18c配置成热和/或电气绝缘的,以防止任何部分粘着组织烧煮或凝结到电极18的表面18s上,降低永久组织堵塞的可能性和通过冲洗或增大流体27的流量或压力使部分粘着组织容易去除。涂层18c也能配置成具有足够低的表面张力,从而组织和其它生物组织不会粘着它。在各种实施例中,表面张力能在50达因/cm以下,希望在50至10达因/cm的范围内,及更希望在40至18达因/cm的范围内,特定实施例具有25、23、19、18.5、18、17和15达因/cm。适当的涂层18c能包括但不限于包括聚酰胺、氟代聚酰胺、PTFE、TEFLON、其它氟-碳聚合物、硅酮、paralene及在先有技术中已知的其它低表面张力非粘着涂层。这样的涂层能在厚度18ct从0.0001至0.1英寸的范围内,一个最佳实施具有0.001至0.003英寸。使用共挤浸渍涂敷、喷涂、共挤、电沉积、等离子涂敷、石印及在先有技术中已知的其它涂敷方法,涂敷涂层18c。
现在参照图18a-18c,在各种实施例中,电极18能包括一个固定或可动筒或护套31s,护套31s覆盖孔径23的一个可选择部分,防止它们在电极插入期间和/或在RF或其它热消融能量的输送期间或之后由组织堵塞或阻塞。对于可动的实施例,护套31s能配置成在电极外部上滑动或穿过内腔72滑动,同时仍然不显著阻塞流体穿过腔流动。在本发明方法的一个实施例中,护套31s能定位在电极18的全部或部分上,从而在把电极插入到组织期间覆盖和保护一个或多个孔径23,并且然后在消融能量的输送之前、期间或之后,以后拉回以允许流体从未覆盖孔径23注入。在一个相关实施例中,护套31s也能配置成用来通过暴露用于注入的带孔径电极18的选择段,控制注入介质27的流量、以及适用于注入的电极18的总面积。
可滑动护套31s的定位能通过把护套配置成直接联接到在机头24上的一个执行器24″上而控制。在可选择实施例中,通过机械或电气联接到护套上由在机头24上的一个执行器24″可执行的一根定位金属丝、凸轮、摇臂开关、棘轮机构、微定位器、或伺服机构等的使用,能控制护套31s的定位。
如这里讨论的那样,一旦电极18定位在希望组织部位处就能拉回(例如,靠近)护套31s,或者在一个可选择实施例中,护套31s能具有一个足够的内径31sid以提供足够的环形通道或厚度31at,允许流体27以环形形式从孔径23流出(在靠近或远离方向上)到希望组织部位。在一个实施例中,护套31s能具有比电极18大1-5mm的直径,提供一个厚度在0.5至2.5mm之间的环形通道。护套31s在手把24处能由医师致动,并且控制其沿电极18的位置。护套31s能由各种聚合物制成,包括但不限于弹性聚合物、弹性体、聚酯、聚酰亚胺、聚氨基甲酸酯、硅酮、PARALENE、含氟聚合物、TEFLON等。也在各种实施例中,可滑动护套31s能配置成电气和/热绝缘的,或者使用在先有技术中传导性聚合物而能是电气和热传导的。传导性聚合物的一个例子包括由Mearthane ProductsCorporation(Cranston,Rhode Island)制造的Durethane C。而且,护套31s的全部或一部分带有不透射线的、不透磁的、或产生回波的标记,便于使用X射线、CAT扫描、nmr超声波等观察和放置护套。
现在参照图19,在配置成减小孔径堵塞的一个电极的另一个实施例中,包括一个针,配置成具有一个针倾斜角68,使组织成芯和因此腔72的堵塞最小。在各种实施例中,针角68能在5至30°的范围内,希望10至20°及更希望12°。
现在参照图20a和20b,在各种实施例中,导引器12或电极18能包括一个多孔远端部分12pds或18pds。多孔远端部分12pds或18pds配置成允许流体从在条带12pds″之间的细孔和/或空隙空间12pds’扩散出。在各种实施例中,部分12pds能包括一个编织部分,该编织部分具有刺入组织的足够刚度或柱强度,而且仍是多孔的足以允许流体通过。编织部分12pds能由在先有技术中已知的、包括高强度材料的编织材料制成,并且能使用在先有技术中已知的、包括丝缠绕技术和碳纤维丝缠绕技术的方法缠绕或编织。适当的编织材料包括诸如能硬化以增加刚性的不锈钢之类的金属带条、或诸如Nylon、聚酯及Kevlar纤维之类的高强度聚合物带条,例子包括由Dupont Corporation制造的Kevlar 29和Kevlar 49。其它适当的编织材料能包括但不限于玻璃纤维、石墨或包括Pitch和Pan基碳纤维的碳纤维。玻璃纤维材料的例子包括由JPS Industries(Greenville,South Carolina)制造的ASTROQUARTZ IIASTROQUARTZ III和样式106、108、7628和7637。通过可定位在多孔部分12pds全部或一部分内的一个结构或硬化件12sm的使用能实现编织或多孔部分12pds或18pds的刚性。在各种实施例中,件12sm能是一个金属心轴,如不锈钢心轴、一个硬化钢心轴或由聚碳酸酯或其它热固聚合物制成的刚性聚合物件。
带条或纤维12pds或18pds的装填或编织能改变,以控制是扩散或吸过纤维的流体量的部分12pds的流体孔隙度。在各种实施例中,部分12pds的孔隙度能在1-2000cc/min/cm2的范围内,希望在10至1000cc/min/cm2的范围内,特定实施例具有20、50、100、250和500cc/min/cm2。
在相关实施例中,部分12pds或18pds的全部和部分能由耐热材料和聚合物构造,从而部分12pds或18pds的强度、刚度或形状在RF或其它热消融能量的输送期间不会显著退化或改变。这样的实施例解决了细长件12的多孔或流体输送部分12pds或其它部分在热消融能量输送到一个组织部位期间能出现的软化或变化问题。适当的耐热聚合物和材料包括在商标ULTEM(下可从General ElectricCompany得到的polyetherimide和在商标UNITREX(下可从GeneralElectric Company得到的polyetheretherketone。在其它实施例中,部分12pds的全部和部分能由导电或耗电聚合物构造。耗电聚合物的例子包括缩醛,如可从General Electric Company得到的UNITAL ESD。在其它实施例中,把一个编织多孔部分12pds配置成增大用于从部分12pds和/或能量输送器件18到流体27或周围组织的传导性热传递的表面面积。这些实施例增强来自能量输送器件18和/或部分12pds的热传递,降低在能量输送器件上或靠近其的组织干燥和炭化的可能性,又降低能量输送器件的阻抗和电源20的阻抗引起断路(即,叫做阻止)。
在另一个实施例中,包括电极18的多孔部分12pds能包括流体联接到腔13或72上并且配置成经本身均匀地把流体渗入或扩散到其表面上和进入组织中的一种多孔、微孔或液体可渗透材料12pm。适当的多孔材料包括聚合物泡沫、聚酯泡沫、OPCELL泡沫、陶瓷、聚酯、聚酯膜、尼龙膜、玻璃纤维膜DACRON、扩展PTFE膜和在先有技术中已知的多孔陶瓷。多孔材料12pm的细孔尺寸能在从5至1000微米的范围内,希望40至500微米,及希望50至150微米。在这些和相关实施例中,多孔部分12pds能配置成吸入、渗入、喷射或喷出流体,以通过传导性、对流性及蒸发性冷却的一种或多种的组合湿润、冲洗及冷却电极。冲洗电极提供防止和/或减小在电极组织界面处的阻抗升高的好处。在实施例中,电极能涂有一个亲水涂层或织构,便于电极表面的湿润。亲水表面的例子包括金属、玻璃、和等离子处理聚合物和金属,由此等离子处理经化学反应和/或与表面附着增大基片表面的表面张力。等离子处理能是在先有技术中已知的各种等离子处理,如氩等离子处理。
在本发明一种方法的一个实施例中,当把电极插入到组织中时和/或在RF或其它热消融能量的输送期间,通过经一个或多个电极腔72注入流体能防止或减少组织堵塞。在各种实施例中,注入速率能在0.1至2ml的范围内,特定实施例具有0.2、0.5、1.0和1.5ml/min。在设备10插入到组织之前或期间、或在针18展开到组织中之前或期间,能启动经诸如注入或注射泵之类的流体输送器件28的组织注入流动。也在一个相关实施例中,使用传感器22能监视到一个或多个电极18的流动以探测产生堵塞,并且能增加或否则修改使用反馈控制(这里描述的)以推出塞子或否则防止塞子形成。在特定实施例中,反馈控制通过流体输送器件能用来启动一个压力或流动脉冲或一系列脉冲或相关波形(例如,方波、正弦波阶跃函数等)以推出产生或存在的塞子。压力脉冲能在0.05至5atm的范围内,希望0.1至2atm,及更希望0.3至2atm。
现在转到讨论与RF能量输送一起的注入的使用,尽管这样一种组合在消融治疗期间呈现优点,但也有技术挑战。两个这样的挑战是(i)不恒定的流动和(ii)不能实现注入的均匀级,和/或不能注入目标组织体积的整个体积,特别是对于只有一个注入端口或注入通道。现在参照图1-2和12-15,本发明的各种实施例通过提供一种设备解决这些问题,该设备配置成经多个电极18或其它注入通道注入流体,从而集体限定一个较大、更可预计和均匀或完整的注入体积,而不是通过从单个电极18或通道可能的那样。这样的实施例解决了没有注入或仅有单个注入通道可能产生的不恒定流动或不完整、不均匀或否则非均匀消融体积的问题。由于不均匀或不完整注入体积和/或在接收不同量的注入流体的希望注入体积内的各区,对于单个注入通道不均匀消融能出现。
在各种实施例中,也能采用这里描述的反馈控制,以改进注入体积的均匀性以及更好地控制注入过程。这能通过利用反馈控制实现,以监视和控制经每个电极18或注入通道72的流量,补偿在任一个通道中的流动变化和保证较均匀的注入体积和以后消融体积。配置成经多个电极注入的本发明的实施例提供这样的优点,减小由来自在目标组织部位5″处的流体压力的单个注入通道生成的、归因于组织阻力、单个电极的阻塞或堵塞的集中背压。因此,通过把注入分散在多个电极和在多个部位处的多个孔径上,能增大整体流量、注入速率及注入体积,并且对于一个选择目标组织,比通过单个注入点的使用,能实现更均匀的注入。具体地说,通过控制到个别电极的液体注入,能经每个电极以希望流量供给液体,而独立于对于其它个别电极的流动的阻力,允许例如相等的流量施加到电极上。
现在参照图21,在本发明一种方法的一个实施例中,经一个或多个电极18或注入通道注入流体,从而围绕每个电极的局部组织注入的个别体积或区5ivl生长或汇集以形成一个大注入体积5iv。这通过控制经电极或注入通道的流量和监视分析或观察注入量实现。注入体积5iv的生长发展能使用包括但不限于超声波、CT扫描、MRI、和X射线的成像方法监视。在本发明方法的各种实施例中,通过X射线、荧光造影剂、回波产生造影剂、或在先有技术中已知的添加到注入介质27上的MRI造影剂的使用能使监视过程容易。在注入过程完成之前、期间或之后能启动消融能量的输送。在一个实施例中,诸如RF能量之类的消融能量的输送仅在汇集大注入体积已经形成之后才开始或者基本上同时开始。在另一个实施例中,在注入之前、在它开始或当局部注入体积正在生长时,开始RF能量的输送。
在可选择实施例中,注入溶液27的输送能通过几种手段增强。在一个实施例中,在注入期间或之后能把超声波能量输送到选择目标组织部位5″,以通过流体声处理、搅拌(流体和组织和/或布朗运动的组合,这模拟摇动在液体中包含一种可溶解固体的瓶子以使固体溶解,增大流体27到包括组织部位5’的间隙空间的组织部位5″的扩散和渗透。而且,能量能配置成引起细胞溶解,能够使流体27扩散到细胞中。超声波能量能由在先有技术中已知的、联接到一个或多个电极上的或联接到一个导液管/探针上的压电换能器输送,导液管/探针又联接到一个超声波能量源上。在各种实施例中,超声波能量能以在从0.5至30MHz范围内的频率输送,更希望从1至10MHz,特定实施例具有2、3、5和8Mhz。
在另一个实施例中,流体输送器件28能配置成产生在流动中的压力脉冲和/或脉动流动以增强扩散。又一个实施例采用RF或直流电压的使用,以产生在先有技术中已知的electroporation效应。直流电压能由联接到具有在先有技术已知的电压的直流电源上的一个分离探针输送,以产生electroporation效应。这样的一个电压源能在0.1至10伏特的范围内。
现在参照图22,在RF输送期间,每个RF电极18配置成靠近每个电极18产生一个消融体积5ave。可以是球形的或柱形的、依赖于活性区域的长度的这个体积这里也称作个别电极消融体积,并且与在RF消融的初始阶段期间通过把一个RF电流(RF功率)施加到该电极上产生的消融体积相对应。当使用多个电极,并且可选择地,把电解溶液从电极注入到组织中时,到多个消融体积,例如球形消融体积,的RF能量施加,将导致每个消融体积膨胀并且最终汇合和重叠,以形成单个组合电极消融体积5avc,这里也称作总体积。
依据希望组合电极消融体积5av的尺寸和形状,能使用不同数量的电极18以产生总消融体积5avc,其体积的形状接近希望消融体积的形状。在各种实施例中,采用2-12,典型地3-10,范围的电极,以产生对应数量的个别电极消融体积。在一个特定实施例中,使用四个电极以产生能具有近似四面体取向的四个消融体积5ave。
在一个相关实施例中,虚拟的固体5ps(这里描述的)能用作用于个别电极消融体积5ave的一块定位几何模板,以便使用最少数量的个别消融体积5ave产生希望集体或总消融体积尺寸5avc。在一个特定实施例中,每个个别电极消融体积5ave这样定位,从而它由相应虚拟的固体的表面5pf的单个表面切开,使一个消融体积5ave定位成在选择虚拟的固体的所有表面上。适当虚拟的固体的例子包括但不限于正方体、四面体和十二面体,如下面讨论的那样。
按照本发明的一个方面,使用一个或多个无源(非消融)传感器元件监视消融体积5av的发展。现在参照图23,设备10包括可从器件12前进和同时或独立于电极18的定位可定位在一个目标组织部位5’中的一个或多个无源(非消融)传感器元件或监视件18pm。如理解的那样,传感器元件携带在输送器件上,在其中用来在其中传感器元件携带在器件的腔内的退回位置、与其中传感器元件(或至少其远端)在输送器件的远端外和远离其展开的展开(包括部分展开)位置之间运动。
典型地,传感器元件在展开时排列在一种弧形、横向延伸、倾斜隔开配置中,使传感器元件定位在与组合电极消融体积对应的体积内,并且使个别传感器元件布置在相邻电极之间,如下面细化的那样。明确地说,传感器元件典型地排列在个别电极消融体积外,在两个相邻电极的消融体积合并的区域中。在这种配置中,在RF消融的早期阶段中,传感器元件布置在个别电极消融体积外。当个别体积膨胀并且开始合并时,消融区域开始与传感器元件位置重叠。通过把传感器元件放置在初始消融体积外,能监视和控制消融体积的扩展、和最终贯穿组合电极消融体积的希望消融程度。
如将理解的那样,多个传感器元件可以集束在一起,用来在退回与展开位置之间作为一个单元运动,如对于电极在以上描述的那样,或者它们可以是个别可运动的,以把传感器元件放置在组合电极消融体积中的不同延伸位置处。当集束在一起时,传感器元件和电极能彼此独立地运动,或者作为一个组合电极/传感器单元在退回与展开位置之间运动。
传感器元件能设计成检测组织性质而不是输送消融能量,并因而能包括一个或多个传感器22,或者要不然,无源件的全部或部分能是检测元件22。最好件18pm配置成非传导性的并且/或者不输送显著量的RF或其它电磁能量。在各种实施例中,这能通过用也能是热绝缘的一个电气绝缘涂层或层18ic涂敷件18m的全部或部分完成。适当的绝缘涂层18ic包括但不限于绝缘聚合物、PARALENE、聚酰亚胺、聚酰胺、TEFLON、NYLON、氟聚合物和在先有技术中已知的其它高介电材料和绝缘体。使用在先有技术中已知的喷涂、浸渍涂敷方法能涂敷该涂层,以产生均匀涂层厚度和一致性。较高介电强度材料的使用提供较薄涂层的好处,这减小无源元件18pm的直径,这又提供使件18pm更柔软的或可操纵以及允许来自导引器12的大量件18pm定位和展开的好处。在各种实施例中,涂层18ic的厚度18ict能在0.001至0.006英寸的范围内,特定实施例具有0.002和0.003英寸。
要不然,无源件18pm的全部或部分能由诸如弹性聚合物管之类的非传导性材料构造,包括但不限于聚乙烯、PEBAX、聚酰亚胺和在导液管技术中已知的其它聚合物。
无源件18pm能由与电极18类似的材料制成,并且/或者具有与其类似的性质,例如组织穿入端、可弯曲性、弹性、记忆性、弹簧记忆性等,这能使件18pm从导引器12展开并且定位在一个目标组织部位5″内的可选择位置处,不同之处在于,件18pm配置成不是传导性的并且不输送消融量的RF或其它电磁能量。在一个实施例中,无源件由304v钢或弹簧钢制成,它带有一个绝缘涂层18ic并且也包括用于流体27和用于联接到传感器22上的电气导线15的通过的一个腔72。
现在参照图24,传感器22能定位在沿一个或多个件18pm的长度的一个或多个位置中。而且在各种实施例中,传感器22能定位在件18pm的表面上或与其平齐-在件18pm内部包括内腔72,或者能集成到包括件18pm的壁18pmw的件18pm上。而且,使用在医疗机械中已知的钎焊或粘合剂粘结技术能定位传感器22。传感器22能直接电气联接到件18pm上(由此一个绝缘传导件18pm提供传感器到这里描述的监视源上的电气联接),或者能电气联接到定位在腔72内并且电气联接到检测源上的一根或多根绝缘导线15上。与件18pm一起使用的适当传感器22包括但不限于这里描述的温度、化学、光学和其它传感器。
在实施例中,传感器22和/或无源件18pm能直接或经一个允许一个或多个选择的无源元件18pm和/或传感器22选择性登记和发信号的多路复用器件联接到监视源20mr上。在各种实施例中,监视源20mr能包括诸如温度或阻抗监视电路之类的监视电路或一个监视单元20mu,监视单元20mu包括监视电路、一个微处理器/控制器、在先有技术中已知的一个观察显示器及报警电路。在一个实施例中,监视单元20mu能集成到或否则电气或光学联接到电源20上。
现在参照图25,在一个实施例中,无源件18pm的多个20pmp能定位以通过包围体积和/或定位在抽样体积的内部限定一个取样体积5sv。能操纵无源件以增大、减小或改变监视的样本体积5sv的形状。在各种实施例中,样本体积5sv能包括消融体积5av的全部或一部分,能大于消融体积以便包括消融体积的全部或一部分,限定基本上与消融体积5sv相同的体积,或者小于由消融体积5av完全或部分限定的消融体积5av。在一个相关实施例中,体积5sv能配置或操纵成基本上与消融体积5av分离或分开。无源件能操纵以限定具有各种几何形状的样本体积,包括但不限于基本上球形的、半球形的、椭圆、棱锥、四面体、矩形、五边形、六边形、或其它可选择虚拟的固体。
参照图26,在一个实施例中,定位无源阵列,以限定由能与消融体积5av近似相对应的一个球近似围绕的一个四面体或棱锥5tv。在这个和其它实施例中,活性阵列或电极18的端部18de能近似定位在选择消融体积的赤道5eq的平面5eqp上。最好,无源件18pm的远端18pmd定位在这个平面上方和下面。在相关实施例中,中央电极18ce能定位在平面5eqp上方,而在其它实施例中,一个或多个电极能定位在平面5eqp上方或下面。而且在相关实施例中,无源件18pm的远端18pmd能配置成限定也由一个球围绕的另一个几何形状,包括但不限于管、矩形、或椭圆。
参照图23,在最佳实施例中,无源元件18pm的展开长度38p比有源元件或电极18长,从而它们能比电极远地定位,并且限定一个比电极大的体积,及该较大体积基本上包含消融体积5av。在各种实施例中,无源元件18pm的长度38p能比电极的展开长度38长0.1至5cm,希望长0.5至2cm,及更希望长1cm。在一个特定实施例中,电极或有源阵列元件长度近似是2.5cm,并且无源阵列元件长度近似是3.5cm。带有比电极18长的一个或多个无源元件18pm的无源阵列18pma的使用,提供能够实时监视消融体积的展开和发展的新颖好处,允许更完全、更快速和受控的消融,并且对于病人又是一种较成功的临床效果。
现在参照图23和26,在这些和相关实施例中,无源元件18pm能定位在电极或有源元件之间的空间中,从而在最远点处或否则与任两个电极或有源元件等距地取样组织体积或区5vz。现在参照图27,在一个实施例中,这能通过配置无源阵列18pma和带有相等数量的等距元件的有源阵列18a并且把无源元件18pm近似定位在切开在近似垂直于导引器12的纵向轴线12al的平面内的任何两个有源元件之间形成的角度18ba的点处最佳地实现。例如,对于带有三个电极和三个无源元件的一个实施例,无源元件相对于三个电极的每一个以近似60°的角度18ba定位。类似地对于带有四个无源元件和四个电极的一个实施例,角度18ba近似是45°。
定位在区5vz中的无源阵列的使用提供完全和均匀消融的较高置信度的好处:区5vz典型地是达到必需引起消融和/或细胞坏死必需的温度的最后区域,并且像这样,是使用RF能量消融的最困难或挑战区域。而且,无源元件18pm的使用消除作为在电极18或其它有源元件18上定位传感器22的结果可能出现的任何信号后生物和/或滞后。因而,通过使用无源阵列取样消融体积5av,本发明的实施例提供整个希望消融体积的组织温度(或指示消融的其它组织性质)的更有代表性和/或准确取样的好处,并且又有高置信度(包括较高统计置信度)实现完全消融。更具体地说,这样的实施例提供贯穿希望组织体积的测量温度对于实际组织温度的较高统计相关、和因而实现希望治疗终点的较高置信度(如由温度或其它测量组织性质指示的那样)。
在本发明方法的一个实施例中,无源阵列能用来测量在消融体积或其它区5vz的最外部分处的温度,从而建立一个临床终点,并且一旦在这些区域处或其附近达到一个可选择的温度就停止或减小能量。这样的实施例提供较快消融时间以及降低损害健康的周围组织和结构,包括诸如器官、神经、血管等之类的关键解剖结构,的危险的好处。在各种实施例中,终点温度能在38至75℃的范围内,希望40至70℃,并且更希望50至70℃,特定实施例是40、41、45、50、55、60和65℃。在一个相关实施例中,在停止能量输送之后,温度能连续监视一个时间段,并且终点能由组织温度的时间衰减估计,以较恒定的消融后组织温度或较慢衰减指示终点。
在一个实施例中,设备能包括三个或多个功率阵列或电极和三个或多个无源阵列。然而,其它实施例能包括任何数量的有源电极和无源元件或其组合,包括但不限于(i)两个或多个电极和两个或多个无源元件;(ii)三个或多个电极和两个或多个无源元件;(iii)两个或多个电极和三个或多个无源元件;(iv)两个或多个电极和一个或多个无源元件;(v)一个或多个电极和两个或多个无源元件;(vi)比无源元件多的电极;(vii)比电极多的无源元件;及(viii)相等数量的无源元件和有源元件。而且在各种实施例中,电极和无源元件的准确数量以及其限定的体积(例如,球形、椭圆)可由医师依据诸如肿瘤的尺寸和形状、肿瘤的一致性和类型(例如,纤维的、血管化程度、坏死等)、肿瘤的位置(例如,肝、骨)及相邻解剖结构的接近性(例如,血管、器官等)之类的因素选择。这能通过在这里描述的、联接到一个或多个电极和无源元件上的一个多路复用器件的使用(从而能够接通或切断它们)或者通过细长件12和/或通过在组织部位处到位的电极或无源元件推进或收回另外的电极和无源元件实现。而且由多个电极和无源元件限定的相应消融或样本体积能由医师通过推进或收回一个或多个电极或无源元件或者转动一个或多个电极或无源元件或两种技术的一种组合调节。
为了讨论容易,现在把导引器12称作套针12;然而这里讨论的所有其它实施例同样适用。现在转到套针12的讨论,并且它与无源阵列18pmp一起使用,在把一个锋利套针12与绝缘无源阵列一起使用时的潜在问题之一是在无源元件18pm上的绝缘18ic的刮削和编织。现在参照图28a-28c,本发明的各种实施例提供对于这个问题的解决方案。如在图28a中表示的那样,一个标准套针12带有一个组织刺入远端16,远端16带有一个锋利引导边缘16le。这个锋利引导边缘当无源件在展开到组织部位5″期间通过它时,能引起一个或多个无源件18pm的绝缘层的刮削或切断。
在各种实施例中,能使引导边缘16le的全部或一部分平滑,以便减小或消除其侵入或切断绝缘层18ic的倾向。在图28b中表示的一个实施例中,只在其内表面16lei的全部或一部分上平滑引导边缘16le,仍然留下一个锋利的外表面16leo。这个实施例提供允许无源件18pm通过和穿过引导边缘16le而不被侵入或切断,并且仍然允许套针末端16是组织刺入(例如,基本上保留切削刃16leo)。在一个实施例中,使用在先有技术中已知的加工铸造、模压或EDM方法把内部引导16lei切成圆角。在另一个实施例中,它能使用在先有技术中已知的金属抛光方法或在先有技术中已知的EDM方法抛光成平滑的。边缘16le也能使用在先有技术中已知的去毛刺方法去毛刺。
在各种实施例中,内部引导边缘16lei能具有在0.0001至0.2英寸范围的曲率半径,特定实施例是0.0005、0.001、0.005、0.0.01、0.05和0.1英寸。在图28c中表示的另一个实施例中,内部引导边缘16lei能平滑,或者否则借助于一个涂敷涂层16c进行非切割,涂层16c能是在先有技术中已知的诸如TEFLON等之类的一个光滑聚合物涂层或诸如聚碳酸酯、丙烯酸等之类的硬平滑涂层。涂层16c能涂敷到引导边缘16le的全部或一部分以及远端区域16上,但希望基本上只涂敷到内部引导边缘16lei上。在又一个可选择实施例中,绝缘切割的问题能使用在先有技术中已知的诸如聚碳酸酯、LUCITE、丙烯酸或高强度聚酰亚胺之类的一个硬化或高强度绝缘涂层解决。在一个相关实施例中,套针远端16的全部或一部分能由配置成具有足够刚度、柱强度及刺入和推进到组织中的相关材料性质;但也配置成具有基上不切割的圆角或光滑内部引导边缘16lei的模压或加工塑料或合成橡胶构造。塑料远端16pl能使用粘合剂粘结、超声波焊接、对接、卷曲或在医疗机械技术中已知的其它管接合方法附加到导引器12上。用于塑料远端16pl的适当材料包括聚碳酸酯、高强度聚乙烯、丙烯酸及在医疗机械技术中已知的其它刚性医用塑料。
在其它实施例中,通过无源件和电极在它们离开套针末端16时的几何布置能减小或防止绝缘切割。现在参照图29,在一个实施例中,无源件18pm和电极18能填充或者否则这样布置,从而无源件18pm在离开套针末端16时不会越过引导边缘16le。在这个和相关实施例中,无源件18pm和电极能以接近多导线电缆的布置的基本上圆形布置50填充或成束,使无源件18pm放置在由有源件或电极围绕的布置的内部50i内,从而无源件在包括引导边缘16le的远端16的内部表面16is中不会通过不会接触。在各种实施例中,电极绕无源件18mpm的填充基本上能是六边形的,以便使填充密度最大,在另一个实施例中,填充布置能是八边形的。在一个实施例中,三个无源件18pm由八个或多个电极18围绕。能通过使用钎焊、粘合剂粘结、或在先有技术中已知的其它导线成束方法在保持在导引器12内的近端位置处接合无源件18pm和电极18,使无源件18pm在填充50内部50i内的保持便利。
现在参照图30和31,在各种实施例中,套针12带有电气绝缘和非绝缘部分12i和12ni。非绝缘部分12ni是传导性的,并且组织消融能接近这个部分出现。然而,如在图30中表示的那样,从部分12i到12ni的过渡12t由于由绝缘层12il的端部生成的套针外径的逐渐减小(从12di到12dni)可能是突然的。这样一种突然过渡12t可能增大轴向阻力或把套针12插入和定位到在目标组织部位处的组织位置远端16中必需的力。在图31中表示的一个实施例中,通过把套针12的一个远端部分16ds配置成具有比套针12的剩余部分大的直径16d,从而远端部分16ds基本上与在套针12的本体上的绝缘层12il平齐(例如,远端直径16d基本上等于部分12i的直径12di),能消除或显著减小过渡12t。
远端部分16ds能由与套针12相同的材料制成(例如,不锈钢、304钢等),并且使用在先有技术中已知的金属、加工、模压或以上方法构造。部分16ds能与套针部分12i成为整体,或者要不然能使用钎焊、铜焊、卷曲或在先有技术中已知的其它金属接合方法接合。把远端部分16ds配置成与套针部分12i平齐减小把套针插入到组织中必需的力并且也平滑地离开插入过程,给医师一种更好的触感以便适当地把套针定位在目标组织部位处。而且一个阶梯套针远端的这些和相关实施例提供便于套针12和远端部分16ds插入和定位在目标组织部位、提高远端部分16ds的放置精度、减小过程时间及增大过程效率的好处。在一个实施例中,远端部分16ds能具有0.087至0.089英寸的外径16dsod,而非绝缘套针的外径12iod是0.080至0.082英寸,及绝缘层12il的厚度在0.0025至0.0045英寸之间。远端部分16ds的长度16dsl能在6.5至8.5mm的范围内。
现在参照图32,在一个实施例中,能量输送器件18的一个或多个的全部或一部分能包括一个放射部分18r。放射部分18r由具有坏死、消融、电离或否则杀死在组织部位5’处的肿瘤组织5″的足够放射强度(例如,居里)的材料构造。在相关实施例中,一个放射吸收护套18s能配置成可滑动地定位在放射部分18r上,以便控制放射部分18r的暴露长度18r’并因而控制输送到肿瘤块5″的放射性剂量。
在部分18r中的放射材料能包括γ、α或β放射材料。适当的γ发射器包括但不限于钴-60、碘-131、铟-123、铟-111、镓-67、及锝-99m。适当的β发射粒子包括氚。在部分18r中放射材料的量能配置成输送0.01至100rads的辐射,特定实施例是0.1、0.25、0.5、1、10和50rads。使用联接到能量输送器件18或导引器12上的一个辐射传感器22能测量输送的辐射量。放射吸收护套18s能包括在先有技术中已知的、浸渍或否则集成到一种柔软金属或聚合物层上的一种或多种放射吸收材料。这样的放射吸收材料包括但不限于铅、铁或石墨。在一个实施例中,使用在先有技术中已知的导液管生产方法能把放射吸收材料构造成一根编织导线或并入护套18s的壁中的护套。
在使用中,放射部分18r提供病人有对肿瘤块的高度瞄准放射性输送同时使对周围组织的损伤最小的辐射疗法的好处。辐射能单独输送或者作为这里描述的另一种消融治疗的附加疗法(在这样的治疗之前、期间或之后),以使癌细胞对其它形式的坏死疗法敏感或否则增加杀死癌组织的可能性。辐射的剂量能在这样的水平下,例如在1rad以下,从而对健康或未治疗组织没有影响,但当与另一种能量疗法结合时,用来超越对于选择肿瘤组织的致死阈值。这样的疗法提供杀死在肿瘤部位处的癌细胞的增大可能性的好处,并因而为病人提供改进的临床结果。
本发明的其它实施例能采用这里描述的治疗肿瘤的光动力疗法。参照图33(表示采用光激活剂的实施例的立体图),在这样的实施例中,设备10能配置成把一种也称作光动力剂27pa的光疗剂27pa输送到目标组织部位。制剂27pa能配置成选择性地吸收在和/或选择性结合到肿瘤块5″上。一旦输送制剂并且由肿瘤5″吸收,能量输送器件的一个光学实施例就用来输送光学辐射,以激活治疗剂5″和引起肿瘤块5″的坏死或消融。然而,在光激活剂27pa之前保持在惰性或无毒状态下。光学能量输送器件18的例子包括光学纤维、光导管、波导管等。光疗剂的例子包括由Pharmacyclics,Inc.(Sunnyvale,Ca)制造的诸如细菌叶绿素-丝氨之类的叶绿素基化合物和诸如镥texaphyrin之类的texaphyrin基化合物。激活辐射的例子包括在频谱的红外、近红外及紫外范围内的辐射。这样的辐射能由这里描述的光学能量输送器件以及在先有技术中已知的其它光学输送器件输送。在一个实施例中,制剂27pa能作为穿过一个骨进入器械或骨活组织检查针的流体直接或经Haversian管输送到肿瘤部位5″。
在各种实施例中,光动力疗法能在诸如RF消融疗法之类的热消融疗法之前、同时或之后进行。在一个相关实施例中,光制剂27pa也能配置成提高输送到肿瘤部位5″的RF或其它电磁能量的高热影响,或者否则选择性地使肿瘤组织对于诸如RF消融治疗的高热肿瘤治疗敏感。在一个特定实施例中,光制剂27pa配置成由包括钙基组织或胶原基组织的骨组织排斥,并因而提高对于肿瘤组织的制剂专一性。在另一个实施例中,光致敏剂能配置成由被骨组织反射而被较暗肿瘤组织吸收的一种波长的光激活。这个和相关实施例提供制剂27pa对肿瘤组织高度专一而对健康骨具有很小或没有影响的好处。而且,制剂27pa的使用允许高热治疗的水平滴定到肿瘤组织的大小和类型。这能通过使用按需要增大或减小肿瘤致敏水平的制剂27pa的频谱完成。
本发明的其它实施例能把这里描述的热或其它消融疗法与化疗或其它基于医药的疗法相结合。设备10能用来在消融之前、期间或之后单独或组合地输送各种化疗或医药制剂。一种这样的制剂族包括配置成抑制各种化疗制剂通过肝的代谢(通过肝酶的禁止)的抗敏基化合物,并因而延长其生物半衰期(例如有效性)同时使副作用最小。这样一种化合物的例子包括由AVI BioPharmaInc(Portland Oregon)制造的NEUGENE抗敏化合物。这样的化合物使用这里描述的或在先有技术中已知的设备10或其它药物输送器械直接输送到肝。
现在参照图34和35,一个反馈控制系统329能连接到能量源320、传感器324及能量输送器件314和316上。反馈控制系统329从传感器324接收温度或阻抗数据,并且由消融能量输出、消融时间、温度、及电流密度的初始设置(“四参数”)修改由能量输送器件314和316接收的电磁能量的量。反馈控制系统329能自动改变四参数的任一个。反馈控制系统329能包括多路复用不同天线的一个多路复用器、提供代表在一个或多个传感器324处探测的温度或阻抗的一个控制信号的一个温度探测电路。一个微处理器能连接到温度控制电路上。
如下讨论特别与RF能量源和肺治疗/消融设备10的使用有关。为这种讨论的目的,现在把能量输送器件314和316称作RF电极/天线314和316,而能量源320现在是一个RF能量源。然而,将理解,这里讨论的所有其它能量输送器件和源同样适用,并且借助于激光光学纤维、微波器件等能利用同与肺治疗/消融设备10相联的那些类似的器件。监视组织、或RF电极314和316的温度,并且相应调节能量源320的输出功率。医师如果希望能超控闭环或开环系统。
设备10的用户能输入与位于设备10处的一个设置位置相对应的一个阻抗值。根据这个值、以及测量的阻抗值,反馈控制系统329确定在RF能量输送时需要的一个最佳功率和时间。为了监视和反馈目的也检测温度。通过使反馈控制系统329把功率输出自动调节成保持某一水平,温度能保持到该水平。
在另一个实施例中,反馈控制系统329确定用于基线设置的一个最佳功率和时间。消融体积和损伤首先形成在基线处。在一个中央核形成在基线处之后,通过延长消融时间能得到较大损伤。通过把能量输送器件316从导引器12的远端16’前进到与一个希望损伤尺寸相对应的位置、和监视在损伤的周缘处的温度从而获得足以产生损伤的温度,能检查损伤产生的完成。
闭环系统329也能利用一个控制器338监视温度、调节RF能量、分析结果、及然后调制功率。更具体地说,控制器338管理功率级、循环、及把RF能量分布到电极314和316达到和保持实现希望治疗目的和终点适当的功率级的持续时间。控制器338也能相互合作地管理电解液的输送、冷却流体、及吸气组织的除去。控制器338也能相互合作地监视往往引起气胸的穿过导引器312的压力泄漏(经压力流动传感器324’),致动联接的控制阀以堵塞引起泄漏的流体路径和/或开始在目标组织部位处的密封剂和/或能量的输送以堵塞泄漏。控制器338能是集成到或否则联接到电源320上。控制器338也能联接到一个输入/输出(I/O)器件上,如键盘、触摸板、PDA、麦克风(联接到驻留在控制器338或其它计算机中的语音识别软件上)等。
现在参照图34,表明反馈控制系统329的全部或各部分。经RF电极314和316(也叫做初级和次级RF电极/天线314和316)输送的电流由一个电流传感器330测量。电压由一个电压传感器332测量。然后在功率和阻抗计算器件334处计算阻抗和功率。这些值然后显示在一个用户接口和显示器336处。代表功率和阻抗值的信号由能是一个微处理器339的控制器338接收。
由控制器338产生一个与在一个实际测量值、与一个希望值之间的差成比例的控制信号。控制信号由功率电路340用来以适当量调节功率输出,以便保持在相应初级/或次天线314和316处输送的希望功率。以类似方式,在传感器324处探测的温度提供用来保持一个选择功率的反馈。在温度测量器件342处测量实际温度,并且把温度显示在用户接口和显示器336处。由控制器338产生一个与在一个实际测量温度、与一个希望温度之间的差成比例的控制信号。控制信号由功率电路340用来以适当量调节功率输出,以便保持在相应传感器324处输送的希望温度。能包括一个多路复用器346,以测量在多个传感器324处的电流、电压和温度,以及在初级电极314与次级电极316之间输送和分布能量。
控制器338能是一个数字或模拟控制器,或带有嵌入的、驻留或否则联接软件的一个计算机。在一个实施例中,控制器338能是由Intel Corporation(Santa Clara,Ca)制造的Pentium族微处理器。当控制器338是计算机时,它能包括经一根系统总线联接的一个CPU。在这方面,系统能是一个键盘、一个软盘驱动器、或其它非易失存储器系统、一个显示器、及其它外围设备,如在先有技术中已知的那样。也联接到总线上的是一个程序存储器和一个数据存储器。在各种实施例中,控制器338能能联接到成像系统上,包括但不限于超声波、CT扫描器(包括快速CT扫描器,如由ImatronCorporation(South San Francisco,CA)制造的那些)、X射线、MRI、乳房X射线等。而且,能利用直接显像和触觉成像。
用户接口和显示器336能包括操作者控制和一个显示器。在一个实施例中,用户接口336能是在先有技术中已知的PDA器件,如由Palm Computing(Santa Clara,Ca)制造的Palm族计算机。接口336能配置成允许用户输入控制和处理变量,以使控制器能够产生适当的命令信号。接口336也能从一个或多个传感器324接收实时处理反馈信息以便由控制器338处理,以管理能量、流体等的输送和分配。
电流传感器330和电压传感器332的输出由控制器338用来保持在初级和次天线314和316处的选择功率级。输送的RF能量的量控制功率的量。输送功率的分布图能包括在控制器338中,并且要输送的能量的预置量也能制成分布图。
电路、软件和到控制器338的反馈生成过程控制、和选择功率的保持,并且用来改变:(i)选择的功率,包括RF、微波、激光等,(ii)工作循环(通-断和瓦数),(iii)双极或单极能量输送及(iv)注入介质输送,包括流量和压力。根据在传感器324处的监视温度,控制和改变这些过程变量,同时保持独立于电压或电流变化的希望功率输送。一个控制器338能并入到反馈控制系统329中以接通和断开电力,以及调制功率。而且,借助于传感器324和反馈控制系统329的使用,与RF电极314和316相邻的组织能保持在希望温度下一个选择的时间段,而不会由于在电极314或相邻组织处的过大电阻抗的产生引起到电极314的功率电路切断。
现在参照图35,电流传感器330和电压传感器332连接到一个模拟放大器344的输入上。模拟放大器344能是一个与传感器324一起使用的常规微分放大器电路。模拟放大器344的输出由一个模拟多路复用器346顺序连接到A/D转换器348的输入上。模拟放大器344的输出是代表相应检测温度的电压。数字化放大器输出电压由A/D转换器348供给到一个微处理器350。微处理器350可以是从Motorola得到的Model No.68HCII。然而,将理解,任何适当的微处理器或通用目的数字或模拟计算机能用来计算阻抗或温度。
微处理器350顺序接收和存储阻抗和温度的数字表示。由微处理器350接收的每个数字值与不同温度和阻抗相对应。在用户接口和显示器336上能指示计算的功率和阻抗值。要不然,或者除功率或阻抗的数值指示之外,能由微处理器350把计算的阻抗和功率值与功率和阻抗极限相比较。当各值超过预定的功率或阻抗值时,在用户接口和显示器336上能给出一个警报,并且另外,能减小、修改或中断RF能量的输送。来自微处理器350的一个控制信号能修改由能量源320供给到RF电极314和316的功率级。以类似方式,在传感器324处探测的温度提供用来确定(i)组织高热(ii)细胞坏死的程度和速率的;及(iii)何时希望细胞坏死已经到达传感器324的实际位置的反馈。
虚拟的固体实施例:本发明方法的一个实施例提供一种利用虚拟的固体使产生大于任何单个消融体积的集合消融体积要求的个别消融数量最小的方法。更具体地说,该实施例提供一种使重叠消融的效果最大以治疗比当前商业适用产品的能力大的肿瘤的方法。这个和相关实施例也适用于多电极器件的设计,其中每个电极将产生一个子损伤,以便产生是较小损伤组合的总损伤。
特定实施例提供用来使用用作来定位重叠消融以产生一个总损伤体积的一块模板的一系列最佳几何形状的一个或多个的方法。为了求出用于子损伤放置的最有效几何形状,显然对于在给定尺寸下给定数量的子损伤,图案越对称总损伤越大。
虚拟的固体包括具有在每个角部处相合的相同数量多边形的规则凸出多边形。在所有虚拟的固体中,边的数量等于或小于顶点的数量。因为目的是减小要求的子损伤的数量,所以把子损伤放置在虚拟的固体的每个表面上,而不是在顶点处。
现在参照图36,在一个实施例中,一个虚拟的固体5ps用作一个模板或基准体积5rv,借助于其放置个别或子损伤以便产生一个较大集合损伤或总损伤5avc。借助于子损伤5ave的中心在虚拟的固体5ps的表面中心上和子损伤的直径围绕虚拟的固体表面的顶点,形成由在相对角部之间测量的虚拟的固体直径限定的一个总损伤。参照图37a-37e的例子,能用作模板或基准体积5rv的虚拟的固体5ps包括但不限于四面体、正方体、八面体、十二面体、及二十面体。
对于带有8或较少面的虚拟的固体,子损伤重叠在总损伤的中心中。对于具有12或更多侧面的虚拟的固体,对于一次完整的体积覆盖要求在总损伤的中心中一个另外的子损伤。使用这种概念和几何形状,有可能构造一个概括产生总损伤要求的最小数量消融的表格。
尺寸/数量 | 4 | 6 | 8 | 12<sup>*</sup> | 20<sup>*</sup> |
1 | 1.06 | 1.23 | 1.23 | 1.65 | 1.9 |
3 | 3.18 | 3.69 | 3.69 | 4.95 | 5.7 |
5 | 5.3 | 6.15 | 6.15 | 8.25 | 9.5 |
*在中心中要求的一次另外消融导致完全体积覆盖
本发明的设备和方法对于使用RF能量和注入流体的良性和恶性肿瘤特别有用。熟悉本专业的技术人员容易明白,器件和方法的各种实施例和实施例的组合能用来取样或消融/损坏体组织、可由经皮或内镜导管接近的组织位置,并且不限于肝中的骨、肺、骨、脑及乳房。这样的组织位置和器官包括但不限于心脏和心血管系统、上呼吸道和胃肠系统以及肝中的骨、肺、骨、脑及乳房。设备和方法在所有这些器官和组织中的应用打算包括在本发明的范围内。
而且本说明书公开了用来治疗在体内的骨和相邻组织区域的各种基于导管的系统和方法。实现本发明特征的方法和系统也适用于与系统和外科操作用在骨和不必基于导管的身体的其它区域中。显然能进行实施例的各种修改、应用、和不同组合,而不脱离要求权利的本发明。
Claims (26)
1.一种组织消融设备,包括:
(a)一个带有一个在远端终止的腔的细长输送器件;
(b)携带在所述器件中的多个电极,其中所述电极能够在退回位置和展开位置之间运动,且其中电极在器件的腔内布置于所述退回位置,所述的电极与电源可操作连接,以响应于电源提供给所述电极的能量产生组织消融,其中
(i)每个展开电极限定一个个别电极消融体积,当把一个RF电流初始施加到在组织中这样展开的该电极上时,该消融体积接近该电极,并且
(ii)对电极连续施加RF电流引起个别电极消融体积增长和彼此汇合以形成一个组合电极消融体积,
(c)携带在所述器件中的多个无源传感器元件,用来在退回位置和展开位置之间运动,其中传感器元件在器件的腔内布置于所述退回位置,而在所述展开位置,该传感器元件从所述远端在多个倾斜隔开位置处展开,且在所述多个倾斜隔开位置处,展开后的传感器元件分布在所述组合电极消融体积内,及
(d)位于每一无源传感器元件上以监测在所述组合电极消融体积中的组织消融的至少一个传感器,
其中供给所述电极的功率可以调节成根据由所述的传感器监测的组织消融在整个所述组合电极消融体积中控制组织消融的水平和程度。
2.根据权利要求1所述的设备,其中可选择地连接所述电极和传感器元件,用来作为一个整体从所述退回位置到所述展开位置运动。
3.根据权利要求1或2所述的设备,其中所述电极可在退回位置和展开位置之间独立于传感器元件的移动而移动。
4.根据权利要求1所述的设备,其中在展开状态时,每个传感器元件布置在个别电极消融体积之外,并且处于展开状态下的一对相邻电极之间的接近中间位置。
5.根据权利要求1所述的设备,其中所述的传感器元件是导线。
6.根据权利要求1所述的设备,其中所述的传感器是热传感器。
7.根据权利要求1所述的设备,其中所述的传感器是光学纤维。
8.根据权利要求1所述的设备,其中所述电极是空心针形电极,允许液体经所述电极注射到组织中。
9.根据权利要求8所述的设备,该设备被设计成允许受控流体单独地流经每个电极。
10.根据权利要求8或9所述的设备,其中至少一个电极沿其远端区域带有多个注入端口,并且由一个护套覆盖,所述护套能够在展开位置与注入位置之间轴向运动的护套覆盖,通过该护套,所述注入端口分别被覆盖和暴露。
11.根据权利要求8或9所述的设备,其中至少一个电极沿其远端区域带有多个注入端口,并且由包括一个固定间隙的护套覆盖。
12.根据权利要求1所述的设备,其中所述电源包括:一个用来向用户显示在所述体积内的消融程度的显示器;和一个可调节电源,借助于该调节电源用户能调节施加到所述电极上的功率。
13.根据权利要求1所述的设备,其中所述电源是可操作的,以响应从所述传感器接收的与在传感器元件的区域中的消融程度有关的信息自动调节施加到所述电极上的功率级。
14.根据权利要求1所述的设备,其中所述电极是空心针形电极,借助于在组织中这样展开的电极,允许液体经所述电极注射到组织中,并且所述电源包括:一个用来向用户显示在所述组合电极消融体积内的消融程度的显示器;和一个可调节流体控制,借助于该可调节流体控制用户能调节供给到个别电极的液体速率。
15.根据权利要求1所述的设备,其中所述电极是空心针形电极,借助于在组织中这样展开的电极,允许液体经所述电极注射到组织中,并且所述电源是可操作的,以响应从所述传感器元件接收的与在所述组合电极消融体积内的消融程度有关的信息控制流体流经电极的速率。
16.根据权利要求1所述的设备,其中所述电极在展开时靠近限定一个期望的组合电极消融体积的一个虚拟的固体的表面中心定位。
17.根据权利要求16所述的设备,其中传感器元件在展开时可以靠近虚拟的固体的顶点定位。
18.根据权利要求16所述的设备,为了消融限定一个棱锥的基本球形体积,该设备具有在展开时靠近棱锥的表面中心定位的四个电极、和在展开时靠近棱锥顶点放置的四个传感器元件。
19.根据权利要求1所述的设备,该设备进一步包括一个适于应用于病人身体表面的身体表面电极和一个控制器件,并且控制器件是可操作的以在多个电极与身体表面电极之间施加功率。
20.根据权利要求1所述的设备,其中所述设备配置成以一种双极模式操作。
21.根据权利要求1所述的设备,其中细长输送器件远端的全部或一部分是塑料。
22.根据权利要求1所述的设备,其中细长输送器件远端的全部或一部分是高弹体。
23.根据权利要求1所述的设备,其中所述细长输送器件配置成带有一个倒角或平滑的内引导边缘。
24.根据权利要求1所述的设备,其进一步包括:
控制器件,其与所述的电极和所述的传感器元件可操作连接,用于对应于从所述的传感器元件收到的信息调节所述电极的功率。
25.根据权利要求1所述的设备,其中所述的电极是被改装以便与RF能量源可操作连接的RF电极。
26.根据权利要求1所述的设备,其中所述的电极是被改装以便与微波能量源可操作连接的微波电极。
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Also Published As
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EP1385439A1 (en) | 2004-02-04 |
US7160296B2 (en) | 2007-01-09 |
US20030212394A1 (en) | 2003-11-13 |
JP2004525726A (ja) | 2004-08-26 |
CA2445392A1 (en) | 2002-11-14 |
CA2445392C (en) | 2011-04-26 |
US20070112342A1 (en) | 2007-05-17 |
JP4252316B2 (ja) | 2009-04-08 |
CN1525839A (zh) | 2004-09-01 |
WO2002089686A1 (en) | 2002-11-14 |
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