CN1323234A - 可扩张式湿电极 - Google Patents

可扩张式湿电极 Download PDF

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CN1323234A
CN1323234A CN99812155.XA CN99812155A CN1323234A CN 1323234 A CN1323234 A CN 1323234A CN 99812155 A CN99812155 A CN 99812155A CN 1323234 A CN1323234 A CN 1323234A
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electrode
radio frequency
needle
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倪以成
苗毅
G·马沙尔
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KU Leuven Research and Development
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    • A61B18/04—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body by heating
    • A61B18/12—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body by heating by passing a current through the tissue to be heated, e.g. high-frequency current
    • A61B18/14—Probes or electrodes therefor
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    • A—HUMAN NECESSITIES
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    • A61N1/00—Electrotherapy; Circuits therefor
    • A61N1/40—Applying electric fields by inductive or capacitive coupling ; Applying radio-frequency signals
    • A61N1/403—Applying electric fields by inductive or capacitive coupling ; Applying radio-frequency signals for thermotherapy, e.g. hyperthermia
    • A—HUMAN NECESSITIES
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    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B18/00—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body
    • A61B2018/00005—Cooling or heating of the probe or tissue immediately surrounding the probe
    • A61B2018/00011—Cooling or heating of the probe or tissue immediately surrounding the probe with fluids
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    • A61B18/00—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body
    • A61B18/04—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body by heating
    • A61B18/12—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body by heating by passing a current through the tissue to be heated, e.g. high-frequency current
    • A61B18/1206—Generators therefor
    • A61B2018/1246—Generators therefor characterised by the output polarity
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    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B18/00—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body
    • A61B18/04—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body by heating
    • A61B18/12—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body by heating by passing a current through the tissue to be heated, e.g. high-frequency current
    • A61B18/14—Probes or electrodes therefor
    • A61B2018/1405—Electrodes having a specific shape
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    • A61B2018/143—Needle multiple needles
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B18/00—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body
    • A61B18/04—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body by heating
    • A61B18/12—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body by heating by passing a current through the tissue to be heated, e.g. high-frequency current
    • A61B18/14—Probes or electrodes therefor
    • A61B2018/1405—Electrodes having a specific shape
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    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B18/00—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body
    • A61B18/04—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body by heating
    • A61B18/12—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body by heating by passing a current through the tissue to be heated, e.g. high-frequency current
    • A61B18/14—Probes or electrodes therefor
    • A61B2018/1472—Probes or electrodes therefor for use with liquid electrolyte, e.g. virtual electrodes

Abstract

本发明涉及一种用于例如在组织烧蚀过程期间施放射频(RF)能量的装置,包含有一个近端(3)和一个远端(4)的传递套管针(5)和一个至少部分地位于传递套管针(5)内的电极扩展装置,包括数根可外伸和回缩的细电极针,每个细电极针具有处于传递套管针内部时的非展开状态和从套管针远端推出时的伞样展开状态,后一状态决定了各展开电极之间的烧蚀体积。所述装置进一步包括用无毒性(RF)导电液使电极远端及附近组织致湿的致湿装置。

Description

可扩张式湿电极
本发明涉及例如在组织烧蚀等过程期间传递射频能量的新颖装置。
本发明具体涉及优化射频烧蚀术所用电极的新概念。以下将该感念命名为可扩张式湿电极。
尽管外科切除术目前仍然被认为是治疗各类恶性肿瘤的首选方法，但是包括冷冻外科手术、局部注射酒精、微波、空隙激光治疗聚焦超声和射频(RF)组织烧蚀术等各类微创替代疗法相继问世，以便用低创伤性手段烧蚀肿瘤，使手术对于病人来说更安全，费用更低，治疗的适应症更广。
在上述各微创疗法中，射频烧蚀术因其低创伤度，简便易行及高效价廉等优点近年来在实验及临床研究中最为令人注目。
在射频烧蚀术中，射频电磁波由射频发生器产生，经事先插入靶组织中的针状电极的非绝缘尖端施放到靶组织中。以凝固性坏死为形式的组织破坏首先由电极周围组织中的阻抗热所造成，其次由周边被动热传导所造成。
阻抗热与中心电极与周围组织之间距离的平方成比例。因此，显著的阻抗热只发生在与电极直接接触的一圈组织中，此圈以外，由于热的被动传导的结果组织被进一步加热。然而，射频辐射很容易因电极-组织界面的电阻升高而被迫中止，后者是由组织脱水和碳化所致。由于这种非优化的射频能量的传递和消耗，使用这种经典电极所造成的杀伤区尺寸小于2厘米，很显然这不足以达到肿瘤烧蚀目的。与外科手术切除的原则类似，射频组织毁灭的理想范围应包括整个瘤体和作为安全带的一层瘤周正常组织以避免肿瘤烧蚀不彻底。
为增大射频烧蚀术的杀伤尺寸，已经作了许多已知技术革新。这些改进包括：
1)双极电极；
2)冷却电极；
3)输入高渗盐水的“湿”电极；以及
4)可扩张式电极。
如表1所示，尽管由这些改进电极所产生的杀伤范围已有所增大，但幅度仍然有限，通常直径仍小于4厘米。如果肿瘤大于2厘米，通过一次射频烧蚀术而致肿瘤完全烧蚀的可能性甚微。因此，仍有必要进一步优化这些相关技术及装置。
表1示出射频烧蚀术所用各种已知电极设计产生的杀伤范围。
                  表1
电极类型      杀伤范围(厘米)    参考文献出处
经典电极      0.8-1.5           1
双极电极      5(为两极间距)     2
冷却电极      1.4-3.6           3
湿电极        4.5±0.75         4
可扩张性电极  4.5               5,6
引用参考文献：
1．Goldberg,S.N.等人(放射学学报Academic Radiology 1995；2:399-404)
2．Goldberg,S.N.等人(放射学学报Acad.Radiol.3/929,1996)
3．Lorentzen,T.A.(放射学学报Acad.Radiol.3:556,1996)
4．Miao Y，等人(外科研究杂志J.Surg.Res.71:19,1997)
5．Rossi,S.等人(AJR.Am.J.Roentgenol.,170:1015-1022,1998)
6．Patterson EJ等人(Ann.Surg,227:559-565,1998)
本发明的主要目的在于提供一种得到良好射频烧蚀效果并提供较大杀伤范围的新颖装置及其方法。具体而言，杀伤范围大于5厘米，较佳地大于6厘米。
本发明是通过对分别的已知特征的组合而实现的，这种组合导致了意想不到的有效射频烧蚀。这是通过高渗盐水与可扩张性电极相结合，显著改善电极组织界面处靶组织的导电性而实现的。
因此，本发明提供一种结合了“湿”电极和可扩张性电极二者特征的传递射频能量的新颖装置。
在实现上述目的中，本发明提供一种如权利要求1所述的装置。较佳实施例被限定在权利要求2至7中。
射频烧蚀技术的一个主要目的是微创性。这种微创性是采用一根针样电极穿刺进入被治疗组织而实现的。因此，本发明的另一目的是增进射频电极的导引的效率。目前是用电极的尖锐的远端穿刺进针。如果这一远端有孔，穿刺时开口就可能会阻塞。
作为克服这个缺点的一种方案，本发明提出加用另外的导引器来辅助仪器(具体为射频电极)的定位穿刺。该电极已事先纵向安插于导引器内。根据本发明，该导引器为一两端开放的空心管筒，其管径与被引导器件的直径相吻合。这里所指被引导器件可以只是一根尖端锐利的穿刺针，可以是用于下一步骤的射频烧蚀电极，也可以是一活检针以获取组织标本作为明确诊断及疗效评判的依据。
本发明进一步涉及使用权利要求8限定的装置和权利要求9至10限定的方法。
以下配合图解具体介绍本发明所涉及装置器件等的结构。
图1示出本发明的可扩张式湿电极的的一个实施例的部分剖面透视图。
图2示出用本发明的扩张式湿电极进行射频烧蚀术的示意图。
图3是图1所示实施例的扩张式湿电极的远端处于回缩状态的情形。
图4为导引器(4a)、穿刺针(4b)和活检针(4c)的部分剖面透视图。
图1所示的电极1即为这里所定义的扩张式湿电极。
向靶组织2传递射频能量的装置1有一个可连接至射频能量发生器的近端3和一个远端4。该装置包括传递套管针5。后者由一空心筒形成，在其远端部分6较佳地与组织穿刺装置7相关。在外套管针5里，安置着多枚(这里为4枚)可回收性空心针样电极8,9，当从外套管针5推出时，其中一根电极9向前直行，另三根电极8则呈放射状伸展。箭头10指出射频导电液(如5％盐水)通过电极8,9的空心管道的流向。该导电液被输注于各电极8,9远端14的邻近组织。
为进一步增大杀伤范围，也可用冷却液至少使各电极8的远端部分冷却。
为顺利穿刺进针，在外套管针5的远端进一步设置穿刺装置7和/或各电极的远端为尖锐。在每根电极8,9尖端处安置温度传感器20可实现精确温度控制。
从以下实验可发现扩张式湿电极的优点和特定特征。
图2示出使用扩张式湿电极1的射频烧蚀方法的示意过程。该电极1在其近端3连接至一射频发生器17。湿装置包括一循环泵15，提供从致湿液容器13通过电极1近端3到靶组织2中待治疗肿瘤的循环。通过一接地板18形成射频电路回路。
图3是电极1的远端6的放大图，表明四根电极8,9处在回收位置的情形。
导引装置100基本上由一开口的长管筒101构成，设置有中心圆柱孔102和圆头开口远端103。空心圆柱管102的管径大小以被导引装置100引导的仪器恰好密合但又可自如纵向抽动为宜。穿刺进入宜使用装在导引装置100内的设置尖锐远端106的穿刺针104，导引装置100与穿刺针104作为一个整体一并引导到待治疗的组织。由于穿刺针104的形状和尺寸及尖锐性可保证穿刺顺利进行。一旦穿刺到位，穿刺针104自导引装置100的空心管筒102中抽出，同时导引装置100保持原位不动。然后将扩张式湿电极自空心管筒102插入直至尖端露出导引装置100的远端。当射频烧蚀术结束时将电极自导引装置100中抽出，而后者仍保持原位。
为提供射频烧蚀效果的证据，可将一活检针109自导引装置100的同一空心管筒中插入被治疗组织，电极缩回到引导装置。活检针109的远端设置有一组织夹具108用于采集被治组织标本以供进一步检验。这些器件为应用射频烧蚀技术提供更多好处。
理想的扩张式湿电极较好地应当包括：一根适合长度(如10-25厘米)及适合外径(如1.5-2.5毫米)的不锈钢针筒，除不足10毫米的尖端外其表面涂敷有绝缘材料；三根或更多由某种合金(如镍-钛)制成的可伸缩性空心细针，当它们处于扩张状态时彼此之间成一定角度向外伸展呈弯爪状；带或不带一根直的空心细针。上述弯形和直形针捆在一起，可以通过针筒呈伸展和回缩状态，这种不同状态可手动或自动地通过移动安装于电极柄内的控制装置来控制。为了监控烧蚀病灶杀伤的温度变化以及便利温控模式，可将热电偶安装于针筒的远端。
射频实验的材料和方法包括均购自本地屠户的重约10公斤的牛肝，在射频烧蚀前将牛肝的温度从4℃升高到室温。
所用设备包括一台射频发生器样品机(RFG-3E,Radionics，美国)和一台盐水循环泵(Ismatic，瑞士)。
实验分组如下：
1)A组：使用扩张式“干”电极的射频烧蚀(无高渗盐水输入)，共20个烧蚀灶(在输出功率50瓦条件下，射频烧蚀维持1-3分钟)。
2)B组：使用本发明的扩张式“湿”电极的射频烧蚀(有高渗盐水输入)，共20个烧蚀灶(在输出功率50瓦条件下，射频烧蚀维持10分钟)。
3)C组：使用本发明的扩张式“湿”电极的射频烧蚀(有高渗盐水输入)，共10个烧蚀灶(在输出功率70-90瓦条件下，射频烧蚀维持30分钟)。
表2综合了在牛肝上所作的射频烧蚀实验的结果。在输出功率50瓦条件下，使用扩张式“干”电极的射频烧蚀(组A)所产生的平均杀伤尺寸为3.5厘米，而且不再进一步增大，这是由于在三分钟时间内电阻急剧升高和功率输出下降所造成的。相反，同样在50瓦输出功率条件下，使用扩张式“湿”电极(输入高渗盐水)的射频烧蚀(B组)可轻易地持续10分钟以上，平均杀伤尺寸约为6厘米。当射频烧蚀继续时间延长至30分钟而且输出功率设定为70-90瓦，杀伤尺寸可达到10厘米以上。
            表2A、B、C组之间的射频烧蚀杀伤尺寸
组别    病灶数    盐水输入(毫升/分)    杀伤尺寸(厘米)
A       20        0                    3.5±0.4
B       20        1.5                  6.3±0.6
C       10        1.5                  8.9±1.2
基于以上对各种类型现有电极的实验研究，研制出射频烧蚀用的本发明扩张式空心电极。在用扩张式“干”电极作射频烧蚀时，射频能量通过3-4个爪形可伸缩性电极传递到较大体积的组织中，导致杀伤范围增大。然而，这种增大的幅度是很有限的，因为每一根电极针与组织的界面处均很快汽化和脱水，造成因电阻过高而引起的射频电流输送中断。另外，这种模式的杀伤区形状不是球形而是不规则形状，即3或4花瓣形状。
在用扩张式湿电极作射频烧蚀时，高渗盐水经每个空心电极针于射频能量施放之前及同时持续不断地输入靶组织中。0.9％的生理盐水的导电性较血液的导电性高3-5倍，较组织的导电性高12-15倍。通过让盐水的浓度提高5倍以上，可进一步改善组织的导电性。盐水在被烧蚀组织中起到一种“液体电极”的作用以及将所施放的射频能量自金属电极向四周组织均匀播散。因此，中央阻抗热环及周围被动传热区域均见增大，从而获得较大的杀伤区。当输注盐水时，电极尖端也受到一定的对流冷却作用。另外，高渗盐水的加入使组织液的沸点升高从而起到延缓汽化的作用。
如我们的实验结果所示，本发明的可扩张式湿电极结合了可扩张式干电极和“湿”电极二者的优点，优化了射频烧蚀的效果。采取这一新颖手段仅需作一次穿刺动作，在一次治疗中却可产生足以导致肿瘤完全烧蚀或根治效果的理想治疗范围。从理论上讲，通过使内部冷却冷却原理与本可扩张湿电极方式相结合，还可制做出另一种新颖电极。
因此，本发明主张在电极-组织界面处将可扩张式电极与加注无毒性导电液结合，以改善电极-组织界面的导电性和增大在射频能量施放期间，例如在组织烧蚀过程期间杀伤范围的新颖申请的权利要求。

Claims (12)

1．一种用于例如在组织烧蚀过程期间施放射频(RF)能量的装置，包含：有一个近端和一个远端的传递套管针和一个至少部分地位于所述传递套管针内的电极扩展装置，包括数根可外伸和回缩的细电极针，每个细电极针具有处于传递套管针内部时的非展开状态和从传递套管针远端推出时的伞样张开状态，后一状态决定了各展开电极之间的烧蚀体积，所述装置进一步包括用无毒性(RF)导电液使电极远端及附近组织致湿的致湿装置。
2．如权利要求1所述的装置，其中细电极针中至少有一个是直的细电极针。
3．如权利要求1或2所述的装置，进一步包括至少使各电极远端致冷的冷却装置。
4．如权利要求1、2或3中所述的装置，其中细电极针为空心的，限定致湿液体的管道。
5．如上述权利要求1-4之一所述的装置，其中所述电极的远端呈尖锐形。
6．如上述权利要求1-5之一所述的装置，其中所述装置进一步设置了一个使电极远端致冷的冷却装置。
7．如上述权利要求1-6之一所述的装置，其中所述电极的远端设置了温度检测装置。
8．在例如射频烧蚀过程中使用的的导引装置，用于引导射频烧蚀穿刺物及其在引导装置中的纵向位移，该引导装置基本上由一开口的中心有圆柱孔的空心管筒形成。
9．如权利要求8所述的导引装置，其中所述引导装置选自穿刺针，射频烧蚀电极以及活检针。
10．如权利要求1-7之一所述的装置用于射频组织烧蚀过程。
11．使如权利要求1-7之一所述射频能量施放装置致湿的过程，包括向所述电极的开放远端及其周围组织提供致湿液的步骤。
12．如权利要求11所述的过程，进一步包括通过对所述电极的内部管道灌注冷却液使电极远端的温度降低。
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