CN1125620C - 多电极的烧蚀装置 - Google Patents

多电极的烧蚀装置 Download PDF

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Publication number
CN1125620C
CN1125620C CN95194583A CN95194583A CN1125620C CN 1125620 C CN1125620 C CN 1125620C CN 95194583 A CN95194583 A CN 95194583A CN 95194583 A CN95194583 A CN 95194583A CN 1125620 C CN1125620 C CN 1125620C
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Prior art keywords
electrode
cell tissue
conducting tube
tissue ablation
electrodes
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CN95194583A
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CN1159154A (zh
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斯图尔特D·爱德华兹
罗纳德G·拉克斯
休·夏基
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Li He Medical System Co.,Ltd.
Rita Medical Systems Inc
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Rita Medical Systems Inc
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Abstract

本发明提供了一种用来治疗和烧蚀躯体肿块诸如肿瘤的细胞组织烧蚀装置，它包括：一具有一末端和一邻近端的输导管和一连接于所述输导管的邻近端的手柄；所述装置还包括：一电极展开装置，它至少部分地位于所述输导管内部，并包括多个可伸缩的电极，这些电极可以自所述输导管的末端伸出并可插入细胞组织内以穿过所述细胞组织并且当位于输导管内时具有一非展开的状态而当从输导管的末端伸出时具有一扩展状态，其中，所述各电极自所述输导管的末端露出而形成一个三维的烧蚀容积。藉此，可以一种侵害性为最小的方式烧蚀掉一所需去除的细胞组织。

Description

多电极的烧蚀装置
                         续展申请资料
本申请是由Edwards等人申请的、题为“用于治疗癌和非恶性肿瘤的设备和方法”的美国专利No.08/148,439的部分续展，所述美国专利援引在本文中作为参考。
                         本发明的背景
本发明的领域
本发明总的涉及一种用来治疗和烧蚀躯体肿块诸如肿瘤的装置，特别涉及一种可伸缩的具有多个针形电极的装置，所述多个针形电极围绕在一肿瘤的外表面周围，并形成一烧蚀容积。
已有技术的描述
目前，用来治疗肿瘤的开放性疗法是极具破坏性的，并会对健康的细胞组织产生很大的损伤。在外科手术中，医生必须十分小心地进行操作，以避免在切除肿瘤时产生肿瘤颗粒，从而导致病灶转移。在最近几年中，肿瘤治疗的发展已经着重将传统外科手术中造成的外伤减至最低限度。
在将高温疗法作为一种用来治疗肿瘤的工具的领域内，人们已经进行了大量的研究。已知提高肿瘤温度对于癌细胞组织的治疗和控制是有帮助的。人们还未彻底理解由高温疗法所提供的根除选择性癌细胞的机理。但是，人们已经提出对癌细胞组织进行高温疗法具有以下四种细胞效应：(i)改变了细胞或核膜的渗透性或液流性，(ii)细胞质溶酶体的解体(cytoplasmic lysomal disintegration)引起消化酶的释放，(iii)蛋白质的热受损影响了细胞的呼吸和DNA或DRA的合成以及(iv)潜在激发免疫系统。用来对肿瘤施加热量的治疗方法包括使用直接接触式射频(RF)高频发热电极、微波辐射、感应耦合的射频场、超声波和各种简单的热传导技术。
在与所有这些治疗方法有关的问题中，有一个问题是需要在躯体表面下几厘米深的深处产生较高的局部热量。目前某些技术已经得到了发展，它们利用微波辐射和超声波来将能量集中在各种所需深度。射频应用也可以用在外科手术中某深度处。但是，总的来说，集中的程度较低，因此可能会损伤健康的细胞组织。
感应加热也引起了入射能量的不良集中。虽然感应加热可以通过将一天线或触角(antenna)放置在躯体表面上来实现，但是，在紧靠所述触角的地方会产生表面涡流。当利用射频电流来驱动所述触角时，会发生不希望的表面加热现象，从而减弱了对下层细胞组织的加热。
因此，用来对体内肿瘤提供热量的非侵害疗法在进行实际特定的和选择性的治疗中具有诸多困难。
可以由一射频源或微波源产生的高温将热量施加于细胞组织，但该高温温度不会超过摄氏45度，因此正常细胞可以幸存下来。在温热疗法中，施加的是高于摄氏45度的热能，结果引起细胞组织受损、脱水和蛋白变性。新近已经采用高温疗法来治疗恶性肿瘤。在高温疗法中，希望能产生一种高温状态，该高温状态是通过对一特定区域进行间隙式电加热并同时确保对健康的周围细胞组织的热损伤为最小而局部化。通常，所述肿瘤是位于皮下，并且所述肿瘤的寻址需要外科手术、内窥镜检查或体外辐射。由于电流密度较稀会被健康细胞组织所吸收，因此较难在较深的躯体细胞组织内由外部传导高温。此外，一部分射频能量在肌肉/脂肪和骨头的界面处被反射，这增加了在一小肿瘤上直接放置一定量的能量的问题。
各种采用间隙式局部高温的尝试已经被证明并不是很成功的。通常所得到的结果是在肿瘤中产生不均匀的温度。人们相信，用高温减小肿块是与热剂量有关的。所谓热剂量是在一定时间内施加于整个肿瘤块的最小有效温度。对于正在被加热的肿瘤来说，血液流动是热损失的主要原因，并且血液流动在流过肿瘤的过程中是变化的，因此，需要对肿瘤细胞组织进行更均匀的加热以保证更有效的治疗。
上述情况也适用于通过利用射频能量来烧蚀肿瘤本身。各种不同方法已经被用来对肿块诸如肿瘤进行射频烧蚀。它是通过施加能量对肿瘤进行烧蚀，而不是对肿瘤进行加热。由于以下各种因素，该疗法很难实现：(i)定位射频烧蚀电极，以有效地烧蚀所有肿块，(ii)将射频烧蚀电极引导到所述肿瘤位置以及(iii)可控地传输和监测射频能量，以进行成功的烧蚀作业而不损伤非肿瘤细胞组织。
对于侵害力为最小的肿瘤治疗来说，目前已经有很多不同的治疗方法和装置。其中一个例子是对肿瘤进行射频高温治疗的内窥镜，如美国专利No.4,920,978中所揭示的那样。在美国专利No.4,409,993中描述了一种微波内窥镜装置。在美国专利No.4,920,978中，揭示了一种用于射频高温治疗的内窥镜。
在美国专利No.4,763,671中，一种侵害力最小的治疗方法采用了两个有间隙地插入肿瘤的输导管。该两输导管被放置在肿瘤体积内，每一输导管与一高频电源相连。
在美国专利No.4,565,200中，描述了一种电极系统，其中使用了一个单入口的插管(tract cannula)来将一电极插入一所选择的躯体治疗位置内。
但是，作为一个有效的治疗设备，诸电极必须相对于所述肿瘤正确定位。在将诸电极定位完毕之后，希望控制施加和吸收射频能量以烧蚀所述肿瘤。这降低了对健康细胞组织的破坏。
因此，需要一种对侵害力为最小的治疗方法有所帮助的射频肿瘤治疗装置。对于这种装置来说，希望它能将诸治疗电极围绕在肿瘤外表面周围，形成一可控的烧蚀容积，随后诸电极传输出可控量的射频能量。此外，还需要一种装置，这种装置在预烧蚀步骤中具有输注性能、并且在烧蚀完成后，可以在低于45度的高温治疗温度下利用电磁能量(“EM”)预先处理周围细胞组织。在局部烧蚀和高温治疗之后，这将能提供化学疗法和在肿瘤位置滴注各种流体的协同作用。
                         本发明的概述
本发明的一个目的在于提供一种射频细胞组织烧蚀装置，这种装置能以一种侵害性为最小的方式烧蚀掉一所需去除的细胞组织，诸如一肿瘤。
本发明的另一目的在于提供一种射频细胞组织烧蚀装置，这种装置包括多个可选择的可伸缩电极，这些电极可以从一输导管中伸出以形成一烧蚀容积。
本发明的再一目的在于提供一种射频细胞组织烧蚀装置，这种装置包括多个可以缩入和伸出一输导管的电极。这些电极至少部分地以一种非展开的状态位于输导管内，并当电极向前伸出输导管末端时能扩展变成展开状态，从而形成所述烧蚀容积。
本发明的又一目的在于提供一种具有诸展开电极的射频细胞组织烧蚀装置，所述电极具有一带第一曲率半径的第一部分，和一第二部分，所述第二部分超出所述第一部分，并带一第二曲率半径或一基本直线型的几何形状。
本发明的又一目的在于提供一种具有诸展开电极的射频细胞组织烧蚀装置，这些展开电极具有两个或两个以上的曲率半径。
本发明的又一目的在于提供一种具有诸展开电极的射频细胞组织烧蚀装置，这些展开电极至少具有一个位于两个或多个平面内的曲率半径。
本发明的又一目的在于提供一种至少具有一个展开电极的射频细胞组织烧蚀装置，所述展开电极具有一个位于输导管的一末端附近的弯曲部分，和一超出展开电极的弯曲部分延伸的非弯曲部分。所述烧蚀装置还至少包括一个至少具有两个曲率半径的展开电极。
本发明的又一目的在于提供一种具有多个可伸缩电极的细胞组织烧蚀装置，每一展开电极至少具有一个位于一输导管的一末端附近的弯曲部分，和一超出展开电极的弯曲部分延伸的非弯曲部分。
这些和其它目的是由一细胞组织烧蚀装置来完成的，所述细胞组织烧蚀装置，它包括：一具有一末端和一邻近端的输导管和一连接于所述输导管的邻近端的手柄；其特点是，所述装置还包括：一电极展开装置，它至少部分地位于所述输导管内部，并包括多个可伸缩的电极，这些电极可以自所述输导管的末端伸出并可插入细胞组织内以穿过所述细胞组织并且当位于输导管内时具有一非展开的状态而当从输导管的末端伸出时具有一扩展状态，其中，所述各电极自所述输导管的末端露出而形成一个三维的烧蚀容积。
一电极模板可以位于输导管末端处。它有助于引导诸电极的展开，以使诸电极能围绕在一位于一细胞组织内的所选择肿块的外表面周围展开。所述诸电极可以是中空的。一可调电极绝缘体可以设置得与所有或一些电极呈相邻、围绕的相互关系。所述电极绝缘体是可调的，并能沿着诸电极向前伸出和向后回缩，以形成一电极导电表面。
所述电极展开装置可以包括一能向前伸出和向后缩入输导管末端的凸轮。在输导管内可选择地包含与一个或多个电极关联的是一个或多个导管。这些导管位于输导管末端。
包括但不限于电解液和化学治疗溶液的注入介质源可以与诸中空的电极相连。诸电极可以具有尖锐的、锥形的端部，以有助于将诸电极插入细胞组织内，并向前到达所选择的细胞组织的位置。
所述电极展开装置可从输导管上拆卸下来。一闭塞器是首先被设置在输导管内。闭塞器可以具有一尖锐的末端。输导管可以经过表皮地向前插入一体内器官或某治疗位置内，并使所述闭塞器是位于输导管内。一旦闭塞器位于输导管内，可以将闭塞器拆卸下来，并将所述电极展开装置插入所述输导管内。当诸电极位于输导管内时，它们呈非展开状态，并最好呈紧凑状态或弹簧加载的状态。诸电极是由一种具有足够强度的材料制成的，因此当诸电极从输导管末端伸出时，诸电极朝着离开输导管末端的周边的侧向呈三维展开。诸电极继续它们的侧向运动直到由细胞组织施加的作用力使针形电极改变它们的运动方向为止。
此时，每一电极或者具有(i)一带第一曲率半径的第一部分，和一超出所述第一部分延伸、并带一第二曲率半径或一基本直线型部分的第二部分，(ii)两个曲率半径，(iii)一个位于两个或多个平面内的曲率半径，或者(iv)两个曲率半径相结合应用，其中一个曲率半径位于两个或多个平面内。此外，对于大多数不同电极来说，所述电极展开装置可以包括一个或多个这些展开形状。每一电极不必具有相同的展开形状。
在诸电极位于一肿块诸如一肿瘤的周围之后，可以在一预烧蚀步骤中，将各种包括但不限于电解液的溶液穿过诸电极输入所述肿块。施加射频能量，并使所述肿块脱水。在一烧蚀后作业中，然后可以将一种化学治疗剂输入所述治疗位置内，并随后将诸电极向后缩入输导管内。可以将整个烧蚀装置拆卸下来，或者可以进行辅助的烧蚀治疗。
                         附图简要说明
图1是本发明的细胞组织烧蚀装置的立体图，所述细胞组织烧蚀装置包括一输导管、一手柄和诸个展开的电极。
图2是图1所示的本发明细胞组织烧蚀装置的剖视图。
图3是具有两个曲率半径的本发明的一电极的立体图。
图4是在三个平面内具有一个曲率半径的本发明的一电极的立体图。
图5是本发明的一电极的立体图，所述电极具有一紧靠所述输导管末端的弯曲部分和一直线型部分。
图6是本发明的一电极的立体图，所述电极具有一紧靠所述输导管末端的弯曲部分、一大体呈直线型的第一直线型部分和一相对于所述第一直线型部分侧向连续的第二直线型部分。
图7是与本发明有关的、具有诸导管的一输导管的剖视图，所述诸导管位于所述输导管末端处。
图8是本发明的一电极的剖视图。
图9是图1所示的本发明细胞组织烧蚀装置的立体图，所述细胞组织烧蚀装置的输导管正在经过表皮地插入穿过躯体、并位于肿瘤的外表面处，或正在轻轻地刺入一带有待烧蚀的肿瘤的肝脏。
图10是具有一位于输导管内的闭塞器的本发明细胞组织烧蚀装置的立体图。
图11是图10所示的本发明细胞组织烧蚀装置的立体图，所述细胞组织烧蚀装置位于躯体内邻近于肝脏的位置处、并除去了所述闭塞器。
图12是图10所示的本发明细胞组织烧蚀装置的立体图，所述细胞组织烧蚀装置位于躯体内邻近于肝脏的位置处，具有一电极模板的电极展开装置位于所述输导管内，以替代所述闭塞器。
图13是本发明细胞组织烧蚀装置的立体图，其中诸展开的电极围绕在一肿瘤周围，并形成一烧蚀容积。
图14是图10所示的本发明细胞组织烧蚀装置的立体图，所述细胞组织烧蚀装置位于躯体内邻近于肝脏的位置处，诸展开的电极围绕在一肿瘤周围并正在预烧蚀作业过程中将一种溶液注入到肿瘤位置。
图15是图10所示的本发明细胞组织烧蚀装置的立体图，它说明了将射频能量施加于肿瘤的应用情况。
图16是本发明细胞组织烧蚀装置的立体图，它说明了肿瘤的电脱水(eletro-desiccation)情况。
图17是本发明细胞组织烧蚀装置的立体图，它说明了在烧蚀后治疗中将溶液滴注于所述肿瘤的情况。
图18示出了本发明的诸电极之间的双极烧蚀作用(bipolar ablation)。
图19示出了本发明的诸电极之间的单极烧蚀作用。
图20是本发明的一烧蚀系统的立体图，所述的烧蚀系统包括射频和超声模块和一监视器。
图21是本发明的烧蚀系统的方框图。
                         较佳实施例的具体描述
图1示出了本发明的一细胞组织烧蚀装置10。烧蚀装置10包括一对于本技术领域的熟练人员来说众所周知的输导管12，所述输导管具有一邻近端14和一末端16。输导管12的长度可以约为0.165至0.528厘米(5至16F)。一手柄18可拆卸地连接于邻近端14上。一电极展开装置至少部分地位于输导管12内，并包括多个可缩入和伸出末端16的电极20。诸电极20可以具有不同的尺寸、形状和结构。在一实施例中，诸电极是大小在27至14规格范围内的针形电极。当诸电极20保持在输导管内时是处于非展开的状态。由于处于非展开的状态，诸电极20可以呈一种紧凑的状态并由弹簧加载，如果诸电极是由一种适当的记忆金属(memory metal)诸如nitinol制成，诸电极将大体受到约束或基本是笔直的。当诸电极20伸出末端16时，它们将扩展呈一种展开的状态，从而能形成一将从其中烧蚀掉细胞组织的烧蚀容积、如图2中更具体示出的那样。诸电极20可以以双极模式或单极模式进行工作。当诸电极以双极模式进行使用时，烧蚀容积将基本上由多个电极20的周边所确定。在一实施例中，所述烧蚀容积的横截面宽度约为4厘米。但是，应予理解的是细胞组织烧蚀装置10也可以具有各种不同的烧蚀容积。
首先确定所述烧蚀容积，以确定一待烧蚀的肿块，诸如一肿瘤。诸电极20以一种预定的方式设置在一肿块或肿瘤的周围，以进行容积的烧蚀。使用一种成像系统来首先确定所述肿瘤或所选择的肿块的体积。适当的成像系统包括但不限于超声波、计算机层析X射线摄影法(CT)扫描、X射线胶片、X射线荧光检查、磁共振成像、电磁成像以及其它类似装置。对于本技术领域的熟练人员来说，利用这些装置来确定一细胞组织肿块或肿瘤的体积是众所周知的。
关于超声波的使用，一超声波传感器将超声波能量传送入一病人躯体内的所需治疗的区域。超声波能量由不同器官和不同细胞组织类型进行反射。反射的能量由传感器感应，并处理形成的电信号，以提供所需区域的图象。随后以该方式确定所述烧蚀容积，并将适当的电极展开装置插入输导管12内。
所述烧蚀容积是在将烧蚀装置10插入烧蚀治疗位置之前就被基本确定下来的。这有助于烧蚀装置10的适当定位。采用这种方式，烧蚀细胞组织的体积得到了降低，并基本被限制在一所确定的肿块或肿瘤，所述确定的肿块或肿瘤包括围绕诸如一肿瘤的某区域，该区域较易控制并确定。烧蚀所述肿瘤周围的一较小区域，以保证能烧蚀掉所有的肿瘤。
请参阅图2。当诸电极部分20(a)伸出末端16时，它们是处于展开状态。虽然当诸电极20位于输导管12内时大体呈不扩展结构处于不展开状态，但是也可以将诸电极扩展。通常，当诸电极部分20(b)不展开时是处于被夹持位置。这可以通过很多方法来实现，这些方法包括但不限于：(i)将诸电极预先加有弹簧的、限制在输导管12内，并且当它们从输导管12中释放出来时只能变得弹出(扩展)，(ii)诸电极由一种记忆金属制成，如下文中更进一步具体描述的那样，(iii)诸电极由一种可选择的电极材料制成，所述材料能使得它们在输导管12外面成为一种扩展的形状或，(iv)输导管12包括诸导管，所述导管用来将诸电极限制在输导管12内，并引导位于输导管外侧的诸电极的延伸方向，以形成所需的、扩展的烧蚀容积。如图2所示，当诸电极20保持在输导管12内时，它们是预先加有弹簧的。这就是不展开位置。当诸电极20伸出输导管12并插入细胞组织时，诸电极20变成展开状，并开始从末端16起呈扇状展开，并朝着相对于输导管12的纵轴成侧向的方向进行移动。由于展开的诸电极20继续向前移动，因此扇形面积逐渐增大，并延伸超过末端16的直径。
重要的是，每一电极20均扩展处于一展开状态，并且总起来说，诸展开的电极20形成一待烧蚀的细胞组织体积。正如先前所提到的，当需要烧蚀一良性肿瘤或恶性肿瘤时，烧蚀的区域最好稍稍大于由肿瘤外表面所确定的区域。这能提高将所有肿瘤都烧蚀除去的机率。
展开的诸电极20可以具有各种不同的展开几何形状，这些形状包括但不限于：(i)具有一第一曲率半径的第一部分，以及一超出所述第一部分延伸的、具有一第二曲率半径或一基本呈直线型形状的第二部分，(ii)至少两个曲率半径，(iii)在两个或多个平面内至少具有一个曲率半径，(iv)一弯曲部分，所述弯曲部分具有一肘部，并位于输导管的末端16附近，以及一超出所述弯曲部分延伸的非弯曲部分，或(v)一靠近末端16的弯曲部分、一第一直线型部分，然后另一弯曲部分或一相对于第一直线型部分倾斜的第二直线型部分。展开的诸电极20不必彼此相互平行。形成针形电极展开装置一部分的多个展开的电极20可以具有相同的展开形状，即，所有的电极都至少具有两个曲率半径，或者具有多种几何形状，即，一个电极具有两个曲率半径，一第二电极在两平面内具有一曲率半径，其余的电极在输导管12的末端16附近具有一弯曲部分，以及一伸出所述弯曲部分的非弯曲部分。
一凸轮22或其它驱动装置可以设置在输导管内，并用来将诸电极伸出和缩入输导管12。在手柄18处可以控制凸轮的实际运动。适当的凸轮是采用传统设计的、对本技术领域的的熟练人员来说是众所周知的。
在图3至图6中示出了诸电极20的各种不同的几何结构。在图3中，电极20具有一第一曲率半径20(c)和一第二曲率半径20(d)。它可以包括两个以上的曲率半径。如图4所示，电极20至少具有一个曲率半径，所述曲率半径延伸至三个平面。在图5中，每一电极具有一位于输导管12末端16附近的第一弯曲部分20(e)。一大体呈直线型的第一直线型部分20(f)超出弯曲部分20(e)延伸，并且两者交会在肘部20(g)处。诸电极20可以用作阳极和阴极。多个电极20可以具有直线型部分20(f)，所述直线型部分大体上彼此相互平行或者也可以不平行。图6示出了一电极20，该电极包括一位于输导管12末端16附近的第一弯曲部分20(e)、一第一直线型部分20(f)，以及一超出第一直线型部分20(f)延伸的第二直线型部分20(h)。第二直线型部分20(h)可以是直线型的、弯曲的或者也可以是该两者的结合。图6所示的多个电极20可以具有平行的或不平行的第一直线型部分20(f)。
在本发明的一实施例中，诸电极20是弹簧加载的，并呈紧凑的非展开的状态。当诸电极20从输导管12末端16向前伸出时，它们将变得展开，并成扇形地展开。诸电极20持续这种扇形展开的方向，直到细胞组织的阻力克服制成电极20的材料的力量为止。这使得电极20发生弯曲，并朝着一相对于其最初向外扇形展开方向、向内的方向移动。这种弯曲就形成了图3所示的弯曲部分20(c)和20(d)，也可以造成图4、图5和图6所示的其它的电极20形状的形成。电极20扇状展开延伸的范围取决于制成所述电极的材料的强度。适当的电极材料包括不锈钢、白金、黄金、银、铜和其它包括导电聚合物的电磁传导材料。电极20最好是由不锈钢或镍钛制成，并且其大小约为27至14规格。
在一实施例中，电极20是由一种诸如镍钛的记忆金属制成的，这种材料可以从加利福尼亚州的Menlo Park市的Paychem公司买到。此外，一耐热构件可以设置在电极20的内腔内。耐热构件可以由一种适当的金属制成，这种金属能将热量传递给电极20，从而当电极20的温度达到能使电极材料诸如一种记忆金属发生挠曲的温度值时，能使展开的电极20产生挠曲变化，正如本技术领域的熟练人员周知的那样。不是所有的电极20都必需由一种记忆金属制成的。可能只有插入细胞组织的电极20末端部分由记忆金属制成，以对所需的展开几何结构发生影响。此外，包括但不限于转向钢丝的机械装置可以连接于电极20的末端，以使它成为指向的、发生挠曲的、并围绕着一所需的方向在细胞组织周围移动，直到它到达其最终静止位置以烧蚀一细胞组织肿块为止。
在输导管内可选择地包括一个或多个图7所示的导管24，当诸电极向前伸出输导管12的末端16时，所述导管能以扇形展开方式引导诸电极20的扩展。诸导管24可以由不锈钢、弹簧钢和包括但不限于尼龙和聚酯的热塑性材料制成，并且具有足够大的尺寸和长度，从而能使诸电极适应躯体内的某特定位置。
图8示出了具有一尖形末端24的电极20的一实施例。通过具有一锥形或穿刺端24，电极20向前穿过细胞组织的运动是较容易的。电极20可以分为几部分，并包括多个流体分送孔26，这些分送孔可以均匀地形成在所有的或仅仅一部分的电极20周围。当电极20为中空时这些流体分送孔26是形成在电极20内，并允许各种流体介质进入和流动穿过20至一所需细胞组织位置。这些流体介质包括但不限于电解液、浆料或凝胶以及化学治疗剂。合适的导电凝胶的例子是由含水的电解液诸如生理盐水和其它类似物制成的羧甲基纤维素凝胶。
诸流体分送孔26的大小可以随着电极20的大小和形状进行变化。与电极20相连的还有一可调节的绝缘套管28，该绝缘套管可以沿着电极20的外表面滑动。绝缘套管28沿着电极20向前推进和向后回缩以确定电极20导电表面的大小。绝缘套管28是由医生在手柄18处操纵的，并且可以控制绝缘套管沿着电极20的位置。当电极20运动伸出输导管12并插入细胞组织时，当电极按其路径运动穿过细胞组织时，绝缘套管28可以位于电极20的周围。或者，在电极20已经位于一待烧蚀的目标肿块的周围之后，绝缘套管28可以在电极20上向前推进一段所需长度。因此，绝缘套管与电极20一起向前推进穿过细胞组织，或者它能运动穿过细胞组织而电极20不提供运动源。因此，所需的烧蚀容积是由展开的诸电极20以及绝缘套管28在每一电极上的位置而确定的。以此方式，可以得到一极其精确的烧蚀容积。形成绝缘套管的适当材料包括但不限于尼龙、聚酰亚胺、其它热塑性材料和其它类似物。
图9示出了细胞组织烧蚀装置10经过表皮的应用。细胞组织烧蚀装置10可以用来经过表皮地将诸电极20引导到所选择的细胞组织肿块或肿瘤。当诸电极20经过表皮地插入躯体内、并到达一具有待烧蚀的所选肿块的所选器官时，诸电极20可以保持在它们的非展开位置上。输导管12可以从手柄18上拆卸下来。当将输导管从手柄上拆卸下来时，可以将电极展开装置(多个电极20)插入和从输导管12上拆卸下来。如果将要进行一经过表皮的作业，可以首先将一闭塞器30插入输导管12内。如图10所示，闭塞器30可以具有一尖头的末端32，该末端可以刺入细胞组织，并有助于将输导管12引导到达一所选择的细胞组织位置。所选择的细胞组织位置可以是一具有一肿瘤或其它肿块的躯体器官，或者就是肿瘤本身。
然后将闭塞器30从输导管12上拆卸下来(图11)。随后将电极展开装置插入输导管12内，并随后将输导管与手柄18再相连(图12)。如图12所示，电极展开装置可以选择地包括一电极模板34，以引导诸电极20的展开方向从而使诸电极能围绕在细胞组织内所选肿块的外表面的周围。
然后使诸电极20向前伸出输导管12的末端16，并变成展开状，以形成一围绕所述肿块的所需烧蚀容积。在图13中，输导管12位于所述肝脏附近。电极展开装置插入具有电极模板34的输导管12内。此时电极展开装置刺入所述肝脏，并且凸轮22将诸电极20向前推进伸出输导管12而呈展开状态。每一单独的电极20均刺入所述肝脏，并穿过所述肝脏，直到所述电极围绕在所述肿瘤的周围为止。所述烧蚀容积是可以选择的，并且可以通过成像待烧蚀的区域而首先确定下来。所述烧蚀容积是由所有围绕在所述肿瘤外表面周围的展开电极20的周边形成的。一旦所述烧蚀容积确定下来，然后选择一将变成展开以形成所述烧蚀容积的一组电极。各种不同的因素在形成一烧蚀容积的过程中是很重要的。首先，不同的诸电极20将具有多种展开程度，该展开程度取决于电极材料的类型、诸电极的预弹簧力的大小和诸电极处于展开状态时的几何形状。细胞组织烧蚀装置10能允许不同的电极组20插入输导管12，以形成多种烧蚀容积。
在对所述肿瘤进行烧蚀之前，可以先进行一预烧蚀步骤。可以将包括电解液诸如盐水的各种不同溶液导入所述肿瘤位置，如图14所示。图15示出了RF能量施加到所述肿瘤的情况。电极绝缘体28位于诸电极20的那些不进行烧蚀的部分上。这进一步确定了所述烧蚀容积。在图16中示出了肿瘤或其它目标肿块或细胞组织的实际电脱水情况。诸展开的电极20带有沿着诸电极的部分而定位的、它们的电极绝缘体再次确定了所述烧蚀容积和所产生的脱水的肿块数量。
可选择地紧接在脱水作业之后，诸电极20可以在烧蚀后作业中输入多种溶液。图17示出了该步骤。适当的溶液包括但不限于化学治疗溶剂。
图18示出了以双极模式进行工作的细胞组织烧蚀装置10。图19示出了它的单极模式工作。多个电极20中的每一个都能在烧蚀作业中起到不同的作用。在各个不同电极之间可以有极性漂移(polarity shifting)。
在图20中示出了一可以制成标准组件的细胞组织烧蚀系统36，并可以包括一显示器38。细胞组织烧蚀系统36还可以包括一RF能量源、微波源、超声波源、诸如照相机和VCR的显像装置、电解和化学治疗溶液源以及一可以被用来监控温度或阻抗的控制器。其中一个展开的电极20可以是一连接于一微波源的微波触角。该电极可以先连接于RF电源42上，并随后转接到所述微波源上。
现请参阅图21。一电源40将能量传送入RF电源发生器(电源)42上，并随后传送给细胞组织烧蚀装置10的诸电极20。一多路调制器46测量电流、电压和温度(在可以设置在诸电极20上的很多温度传感器处)。多路调制器46由一控制器48或一具有软件的计算机所驱动，所述控制器可以是一种数字控制器或模拟控制器。当控制器48是一计算机时，它可以包括一通过一系统总线连接的计算机中心处理装置。该系统可以包括一键盘、磁盘驱动器或其它永久的存储系统、一显示器和其它在本技术领域中已知的附加设备。连接于所述总线的还有一程序存储器和一数据存储器。
一操作接口50包括操作控制器52和显示器38。控制器48连接于成像系统，并包括超声波传感器、温度传感器以及，如果包括在内的话，观察光学仪器和光导纤维。
电流和电压被用来计算阻抗。诊断是通过超声波、CT扫描或其它本技术领域已知方法进行的。成像可以在治疗之前、治疗过程中和治疗之后进行。
温度传感器测量被传送的电压和电流。控制器48使用这些传感器的输出，用来控制RF电源的传输。控制器48还可以控制温度和功率。所传输的RF能量的大小控制功率的大小。所传输的功率的分布可以包括在控制器38内，并且待传输的预定量的能量也可以用图形显示。
反馈可以测量阻抗或温度，如果它具有一控制器，并在控制器48上进行或在例如RF或微波的电磁能源42处进行。对于阻抗测量来说，这可以通过供给少量的非烧蚀RF能量而实现。然后测量电压和电流。
电路、软件和对控制器48的反馈形成了程序控制，并被用来改变(i)包括RF、超声波和其它类似物的功率，(ii)工作周期(开关和瓦数)，(iii)电极或双极能量的传输，(iv)化学治疗和电极溶液的传输、流动速率和压力，以及(v)当完成烧蚀作业时确定整个时间、温度和/或阻抗。这些过程变量可以得到控制，并能根据在多点处监测到的温度以及对所监测电流的阻抗而变化，从而指示在烧蚀作业中细胞组织的带电性能的变化。
以上是本发明较佳实施例的具体描述，以说明和描述本发明。不应该认为上述描述是完全的或是将本发明限制于所揭示的形式。显然，对于本技术领域的熟练人员来说还能作出很多改进和变化。所选择和描述的实施例是为了最好地说明本发明的精神和其实际应用，由此使本技术领域的其它熟练人员能理解本发明的各种实施例，并具有各种改进适合于所考虑的特定使用情况。本发明的保护范围应由所附的权利要求书来确定。

Claims (30)

1.一种细胞组织烧蚀装置，它包括：一具有一末端和一邻近端的输导管和一连接于所述输导管的邻近端的手柄；其特征在于，所述装置还包括：
一电极展开装置，它至少部分地位于所述输导管内部，并包括多个可伸缩的电极，这些电极可以自所述输导管的末端伸出并可插入细胞组织内以穿过所述细胞组织，并且当位于输导管内时具有一非展开的状态而当从输导管的末端伸出时具有一扩展状态，其中，所述各电极自所述输导管的末端露出而形成一个三维的烧蚀容积。
2.如权利要求1所述的细胞组织烧蚀装置，还包括：
一电极模板，它位于所述输导管的末端处用来引导诸电极的展开方向使诸电极围绕在一位于细胞组织内的所选肿块的外表面周围。
3.如权利要求1所述的细胞组织烧蚀装置，其特征在于，诸电极是中空的，并包括诸流体分送孔。
4.如权利要求1所述的细胞组织烧蚀装置，还包括：
一可调的电极绝缘体，它位于每一电极附近、并围绕在每一电极的周围，每一可调电极绝缘体能沿着一电极向前伸出和向后回缩，以限定一电极导电表面。
5.如权利要求1所述的细胞组织烧蚀装置，还包括；
一与电极展开装置相联的电极伸缩件，用来将诸电极向前伸出和向后缩入所述输导管末端。
6.如权利要求1所述的细胞组织烧蚀装置，还包括：
位于所述输导管内的一个或多个导管。
7.如权利要求3所述的细胞组织烧蚀装置，还包括：
一与每一电极相连的注入介质源。
8.如权利要求3所述的细胞组织烧蚀装置，还包括：
一与每一电极相连的化学治疗试剂源。
9.如权利要求1所述的细胞组织烧蚀装置，其特征在于，每一电极具有一尖锐的末端。
10.如权利要求1所述的细胞组织烧蚀装置，其特征在于，所述电极展开装置可从所述输导管上拆卸下来。
11.如权利要求10所述的细胞组织烧蚀装置，还包括：
一位于所述输导管内的可拆卸的闭塞器。
12.如权利要求11所述的细胞组织烧蚀装置，其特征在于，所述闭塞器具有一尖锐的末端。
13.如权利要求10所述的细胞组织烧蚀装置，其特征在于，所述输导管可从所述手柄上拆卸下来。
14.如权利要求11所述的细胞组织烧蚀装置，其特征在于，所述闭塞器位于所述输导管内，并能将所述输导管引入一躯体内位置。
15.如权利要求11所述的细胞组织烧蚀装置，其特征在于，在将所述输导管插入一躯体内位置之后，所述闭塞器从所述输导管上拆卸下来，并随后将所述电极展开装置设置在所述输导管内。
16.如权利要求1所述的细胞组织烧蚀装置，其特征在于，所述烧蚀容积由处于所述扩展状态的所述多个电极的周缘界定。
17.如前述任一权利要求所述的细胞组织烧蚀装置，其特征在于，所述各电极是预压缩的且被限制在所述输导管内，这样当自所述输导管的所述末端部伸出时，所述各电极就扩展开并自所述输导管的所述末端部向外散开。
18.如权利要求1至16中任一权利要求所述的细胞组织烧蚀装置，其特征在于，所述各电极包括记忆金属或弹簧钢。
19.如权利要求1至16中任一权利要求所述的细胞组织烧蚀装置，其特征在于，它还包括一根或多根与所述电极相连的钢丝。
20.如权利要求1至16中任一权利要求所述的细胞组织烧蚀装置，其特征在于，它还包括一将所述输导管保持在一细胞组织位置处的装置，所述装置包括一可自所述输导管上拆卸下来的手柄。
21.如权利要求1至16中任一权利要求所述的细胞组织烧蚀装置，其特征在于，所述电极呈丝状。
22.如权利要求1至16中任一权利要求所述的细胞组织烧蚀装置，其特征在于，所述电极包括一中空管子。
23.如权利要求1所述的细胞组织烧蚀装置，其特征于，它还包括与至少一个所述电极相连的射频能量电源。
24.如权利要求23所述的细胞组织烧蚀装置，其特征在于，它还包括一与射频电极的至少其中之一连接的传感器。
25.如权利要求24所述的细胞组织烧蚀装置，其特征在于，它还包括与所述传感器和所述射频电极的至少其中之一或者射频能量源连接、根据系统阻抗来控制射频能量的施加的控制装置。
26.如权利要求24所述的细胞组织烧蚀装置，其特征在于，它还包括与所述传感器和所述射频电极的至少其中之一或者射频能量源连接、根据一测量温度来控制射频能量的施加的控制装置。
27.如权利要求1至16中任一权利要求所述的细胞组织烧蚀装置，其特征在于，它用于单极能量传输。
28.如权利要求1至16中任一权利要求所述的细胞组织烧蚀装置，其特征在于，它用于双极能量传输。
29.如权利要求3所述的细胞组织烧蚀装置，其特征在于，所述流体分送孔是一系列定位于所述电极末端的端部区域灌注孔。
30.如权利要求3所述的细胞组织烧蚀装置，其特征在于，所述流体分送孔位于所述电极侧面上。
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PT1366725E (pt) 2007-03-30
US5536267A (en) 1996-07-16
DE69535379D1 (de) 2007-03-15
ES2132698T5 (es) 2004-07-01
ATE352263T1 (de) 2007-02-15
US6632222B1 (en) 2003-10-14
ES2132698T3 (es) 1999-08-16
EP0777445B1 (en) 1999-06-02
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ATE253871T1 (de) 2003-11-15
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ATE180649T1 (de) 1999-06-15
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DK1366725T3 (da) 2007-05-29
CN1159154A (zh) 1997-09-10
DE69535379T2 (de) 2008-01-03
DE69532140T2 (de) 2004-08-26
EP0908156B1 (en) 2003-11-12
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US6471698B1 (en) 2002-10-29
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