CN1336812A - 电外科系统 - Google Patents
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- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
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- A—HUMAN NECESSITIES
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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
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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
- A61B18/14—Probes or electrodes therefor
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- A61B2218/001—Details of surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body having means for irrigation and/or aspiration of substances to and/or from the surgical site
- A61B2218/002—Irrigation
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B2218/00—Details of surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body
- A61B2218/001—Details of surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body having means for irrigation and/or aspiration of substances to and/or from the surgical site
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- A61B90/00—Instruments, implements or accessories specially adapted for surgery or diagnosis and not covered by any of the groups A61B1/00 - A61B50/00, e.g. for luxation treatment or for protecting wound edges
- A61B90/40—Apparatus fixed or close to patients specially adapted for providing an aseptic surgical environment
Abstract
一种电外科系统,包括射频发生器(1)、电外科仪器(E1)和液体罩(42)。发生器(1)具有射频输出,用于在浸渍在电传导液体中时将功率输送到电外科仪器(E1)。电外科仪器(E1)在其远端具有电极组件(32),电极组件包括组织治疗电极(34)和回流电极(38),回流电极(38)以在使用中确定传导性液体路径的方式与组织治疗电极轴向间隔开,该传导性液体路径使组织治疗电极和回流电极之间的电回路接通。液体罩(42)适用于围绕患者皮肤上的手术部位或者切口,该手术部位或切口通向在患者身体内外科手术形成的空腔。液体罩(42)包括用于对患者组织密封的密封装置(44),并且液体罩包括至少一个端口(50a、52a),电外科仪器(E1)可以通过该端口插入,并且电传导液体可以通过该端口进入和/或离开罩。
Description
技术领域
本发明涉及一种电外科系统，用于在电传导液体介质存在时的组织治疗，特别是涉及这种包括液体隔离罩(enclosure)的系统，液体隔离罩便于浸渍在患者身体上或内部中的组织，从而该系统可以用来使这类组织汽化、凝结、干燥或者其它形式的热变性。
背景技术
内镜的电外科对于治疗体腔中的组织是有用的，其通常在扩张介质存在时起作用。当扩张介质是液体时，其通常称作水下电外科，该术语表示如下的电外科，其中在手术部位采用具有浸渍在液体中的治疗电极(一个或多个)的电外科仪器对有生命的组织进行治疗。
水下外科手术通常采用内镜技术进行，其中内镜自身可为电极通过提供导管(通常称作工作通道)。另一种方案是，内镜可能特别适合于(如在可切除范围中)包括安装电极的装置，或者电极可以经由单独的入口装置与内镜成一角度引进体腔内，这是一种通常称作三角剖分(triangulation)的技术。这些技术根据要治疗的体腔的特征、位置和入口选择。
当无自然体腔时，人们可以采用各种仪器或者可扩张的球体来创造。该技术用在内镜的隐静脉静脉采集、内镜的腹膜外疝修复中，以及其它形成实现和进行外科手术过程的皮下管道的情况。一般，形成的袋囊或空腔不被液体扩张，该过程使用这样的仪器进行，即那些一般用于进行腹腔镜检法的外科手术(在腹腔空腔中进行的内镜检查外科手术)的仪器。腹腔镜检法外科手术也在气体或机械扩张中进行。
电外科通常使用单极仪器或双极仪器实现。采用单极电外科时，活性电极用在手术区，传导性回流板(return plate)固定到患者皮肤上。由于采用这种配置，电流从活性电极流经患者的组织到达外部回流板。由于患者代表回路的大部分，所以输入功率值必须较高(一般为150至250瓦)，来补偿患者组织的阻抗电流限制，在水下电外科的情况下，是补偿由于液体介质而损失的功率，液体介质因血液或者其它体液的存在而局部具有传导性。采用高功率的单极装置也是危险的，这是由于在回流板处组织加热可以引起严重的皮肤灼烧。在体腔的进入点处，在仪器和患者组织之间的电容耦合也存在危险。
采用双极电外科时，在组织治疗部位同时使用一对电极(活性电极和回流电极)。由于两个电极的相对较近，该配置从安全角度考虑具有优点，从而射频电流局限于两个电极之间的区域。然而，作用深度与两个电极之间的距离直接有关；并且，在需要极小电极的作用场合，电极间的间距变得极小，由此限制了组织作用和输出功率。进一步分隔电极之间的间距通常会挡住作用部位的视线，并且需要改进外科手术的技术来确保两个电极与组织之间正确接触。
当在皮肤表面上使用双极或单极的电外科时，有着过度热损害和组织碳化的高危险性。这是由于皮肤的表皮层比多数脉管组织或湿性组织具有较高的电阻抗。这种热损害和碳化可以导致治愈延迟、伤口感染和形成过大疤痕。除了这些问题之外，当使用双极装置时，皮肤和回流电极之间的电阻抗可能显著地降低有效性。为了克服该问题，在本领域中公知的现有装置如US专利申请4202337中，使用了刀片状或针状电极结构的双极成对电极的多种配置，其穿透表皮层的高阻抗表皮层，从而一个或多个回流电极和组织形成了充分的电接触。
对于双极探针的基本设计已经有了多种改进。例如，美国专利申请4706667描述了基本设计的其中一个，即为了切割或切除的目的，回流电极和活性电极的接触面积比为大于7∶1且小于20∶1。例如美国专利申请5403311中描述的，当双极仪器用于凝结和干燥时，两个电极之间的接触面积比必须降低到大约1∶1，以避免在组织和电极之间的接触时产生电压差。
回流电极和组织之间的电接合可以用诸如生理盐水这样的传导性溶液润湿组织而维持。这保证了外科手术效果局限于活性电极，两个电极之间的电回路因组织而接通。这种设计的一个明显缺陷在于：活性电极(诸如针)必须完全埋在组织中，使回流电极能够接通电路。另一个问题是取向：即使是作用角度从相对于组织表面的理想垂直接触有较小变化时，取向也将改变接触面积比，从而可以在组织与回流电极接触时外科手术产生作用。
空腔扩张为手术部位形成入口、提高可视性、以及仪器操作提供空间。在低容量的体腔中，特别是需要在较高压力下扩张空腔的情况下，由于液体有较好的视觉性质所以更常用液体而非气体，并且液体将血液从手术部位冲洗掉。
申请人已经发现下面的情况是可行的：在水下内镜电外科中使用传导性液体介质(如生理盐水)来代替非传导性、无电解质溶液。在不考虑电外科时或者在使用诸如激光治疗的非电组织作用时，生理盐水在水下内镜外科手术中是优选的扩张介质。尽管生理盐水(0.9％w/v；150mmol/l)具有略高于多数身体组织的电传导性，但是它的优点在于：从手术部位通过吸收或者外渗进行置换几乎不产生生理影响，并且避免了非传导性、无电解质溶液的所谓的水中毒作用。
申请人已经开发了一种双极仪器，其适用于使用传导性液体介质进行水下电外科。仪器和其操作的进一步详情在我方欧洲专利申请96918768.1的说明书中公开，其内容在此引用作为参考。该仪器的操作需要：其浸渍在电传导液体中，从而液体使轴向设置在仪器轴上的两个电极之间的电回路接通。该仪器连接到电外科的发生器中，该发生器是在我方欧洲专利申请96304558.8的说明中描述的类型，该申请的内容在此引用作为参考，从而在手术中，仪器的活性电极或组织治疗电极可以对组织结构产生汽化、凝结、干燥或热变性。
96918768.1中的对浸渍该仪器的要求限制了对于具有自然边界的身体部位的使用，从而空腔形成的尺寸和解剖学位置对于由电传导液体的扩张是适合的，例如在关节、子宫、膀胱/尿道和颅腔中。
美国专利申请4381007中描述了橡胶边缘(skirt)的使用，其用作对传导性冷却剂液体的阻塞装置，该传导性冷却剂液体用于清洗眼角膜。该液体的目的在于：维持电流在两个或多个电极之间流动，这些电极对称设置并与角膜有预定的距离，从而表层表面冷却，而治疗表面深处的组织足以矫正屈光缺陷。
出于进行内镜外科手术的目的，为了在组织中形成人造腔，皮下穿过的手术也成了普通手术。通常，由于这些人造腔不会随着液体而扩张，所以使用了传统的双极或单极仪器。这些空腔用可充盈的球体或可扩张的钝头仪器形成在组织平面之间，内镜和仪器可以通过这些空腔插入。
我方欧洲专利申请97900315.9的说明书(其内容在此引用作为参考)描述了96918768.1的仪器使用的另一个实施例，以及该仪器的应用，用于产生骨盆底部(pelvic floor)热导致的收缩作为膀胱颈缩(neckdescent)的矫正治疗。
发明内容
本发明提供了一种电外科系统，其包括：射频发生器、电外科仪器和液体罩。该发生器具有射频输出，用于当浸渍在电传导液体中时，将功率输送到电外科仪器；电外科仪器在其远端具有电极组件，电极组件包括组织治疗电极和与其轴向隔开的回流电极，从而在使用中限定使组织治疗电极和回流电极之间的电回路接通的传导液体路径；其中液体罩适合于围绕患者皮肤上的手术部位或切口，该手术部位或切口通向外科手术形成在患者身体内的空腔，其中液体罩包括密封装置，用于对患者组织密封，液体罩包括至少一个端口，通过该端口，电外科仪器可以插入，并且通过该孔电传导液体可以进入和/或离开罩。
有利的是，液体罩设置有入口，通过该入口，电外科仪器可以插入，并且优选液体罩设置有端口装置，用于向液体罩施加电传导液体并从液体罩除去所述液体。该液体罩可以具有液体流入管和液体流出管，各管与流体罩中的对应端口相连。方便的是，液体流入管在其远端设置有多个开孔。
优选的是，入口适于容纳内镜，在使用中电外科仪器可通过内镜插入。在该情形下，液体罩可以具有端口，电传导液体可以通过该端口从罩中除去，内镜中的工作管构成了用于将电传导液体输送到液体罩内部中的管。
在优选实施例中，液体罩具有窗口，外科医生可以通过该窗口看见围绕着组织治疗电极的区域。该窗口可以为放大窗口。
在一个优选的构型中，电外科仪器是单极仪器，在其远端具有单个组织治疗电极，在使用中位于组织治疗电极附近的金属卡圈构成回流电极，金属卡圈和组织治疗电极连接到发生器上。
有利的是，液体罩是这样的：它覆盖着围绕手术部位或切口的皮肤区域，该区域大致大于手术部位或切口区域，由此含在液体罩中的电传导液体量足够大，以确保其热容量对于从正在治疗的组织上除去热量是有效的。
在优选实施例中，密封装置由设置在液体罩上的向外延伸的凸缘构成。优选的是，该凸缘与液体罩一体形成。
该液体罩确保了在此所述的任何专利申请中的电外科仪器可以用在身体或解剖结构的表面上，使各种组织汽化、凝结、干燥或热变性。
此外，在使用这些仪器对各种组织进行汽化、凝固、干燥或热变性的过程中，液体罩可以用于确立和保持人造腔的液体扩张。
在另一情况下，液体罩还可以包括仪器入口装置来转换标准内镜解剖仪器，从而可以利用在我方欧洲专利申请96304558.8中描述的发生器，使得这些仪器可以用于干燥或凝结组织结构。
我方欧洲专利申请96918768.1中涉及了一种电外科仪器，用于在膀胱颈缩矫正治疗时骨盆底部形成热导致的收缩。本发明提供了骨盆底部的入口以有利于对其应用的一种方法。
本发明还提供了一种液体罩装置，用在电外科过程中，该装置包括半透明的柔性网件(web member)，在其周边上具有密封凸缘用于在患者皮肤上形成大致不透液体的密封，由此使得组织能够在由患者皮肤形成的大致不透液体的罩和柔软网件中治疗，在网件中至少第一孔能够将电外科仪器引进罩中，而同时保持大致不透液体密封的整体性。
有利的是，该装置还包括能够将电传导液体补给到罩中的第二孔、能够将废物从罩中除去的第三孔、从第三孔延伸进罩中的液体流出管，流出管在电传导液体中是能飘浮的。
本发明还提供了一种使用电外科系统的治疗组织的方法，该系统包括电：外科发生器，其适用于产生第一和第二输出端子之间的射频振荡电压输出；电外科仪器，具有连接到第一发生器输出端子的活性组织治疗电极；液体输送装置，用于将电传导液体输送到要治疗的组织；以及回流电极，连接到第二发生器输出端子上。该方法包括如下步骤：以大致不透液体的方式封闭空间，将要治疗的组织位于空间中，并且至少所述活性电极位于空间中；操作液体输送装置，用电传导液体至少填充部分空间；操作发生器，将射频电压施加到活性电极和回流电极之间，并且用电传导液体将活性电极和回流电极之间的传导路径的至少一部分接通；在将要治疗的组织附近控制活性电极。
有利的是，该方法还包括将回流电极定位在空间中的步骤。
优选的是，电外科仪器包括轴，活性电极和回流电极位于该轴的远端，该方法还包括如下步骤：使轴的近端从空间延伸出来及通过移动轴的近端控制活性电极。
方便的是，电传导液体连续供应到空间，该方法还包括从空间内除去废物物质的步骤。
该空间可以通过与患者皮肤形成了密封(seal)的柔性封闭件来封闭，该方法还包括步骤：降低空间内压力到低于空间紧邻外部的空气压力的水平。另一种方案是，该空间可以通过与患者皮肤形成了密封的柔性封闭件来封闭，该方法还包括步骤：将柔韧件粘结地固定到患者皮肤上。
优选的是，封闭步骤使空间封闭了表皮层区域。在该情况下，可以控制活性电极达到下述方面的至少其中一个：皮肤疾患的治疗；肿瘤的除去；擦皮法；皱纹的减少；皱纹的去除；日光角化症的治疗；基底细胞癌的治疗。
另一种方案是，封闭步骤使空间封闭了空腔，将要治疗的组织位于空腔内。该空腔可以为自然体腔。在该情况下，可以控制活性电极达到下述方面的至少其中一个：胶原蛋白纤维的热变性、主质和间质(mesanchymal)肿瘤的治疗。胶原蛋白纤维的热变性可以矫正膀胱颈缩或者治疗韧带或腱。
本发明的一个优点在于：组织结构如皮肤浸渍在电传导液体中降低了电外科输出的阻抗，从而皮肤表面可被切除、汽化、造型(皮肤热腐蚀)或者其它热变性，而同时使疤痕形成以及对组织边缘的不理想的热损害最小化。这在清除伤口或者溃疡时，以及在治疗各种皮肤或皮肤抗原疾病时是特别有利的。这些疾病包括：恶性肿瘤(与皮肤有关的原发性或继发性)；葡萄酒色痣；毛细管扩张；肉芽肿；腺瘤；血管瘤；肿瘤色素；痣；增生和发炎纤维状丘疹；肥大性酒渣鼻；皮脂溢性角化病；淋巴细胞瘤；血管纤维瘤；疣；神经纤维瘤；湿疣；疤痕疙瘩或肥大性疤痕组织。
本发明的另一个优点在于：通过将结构浸渍在电传导液体中使得干燥能力大大提高，特别是本发明用于简单的探针型装置如钩子上时。这是几个因素的结果。这些因素中第一个因素涉及的是：在外科手术过程中，组织表面非常快速的干燥，这样降低了与组织电接触的阻抗。由于干燥性能由电流驱动(current-driven)，所以高阻抗阻止了充分电流输送，干燥电压范围的输出阻抗被超过。结果，该组织未彻底干燥，并且如果在血管干燥过程中该情况发生，则管腔仍为开放的且任何流血不能得到控制。这些因素中的第二个因素作为粘结到组织治疗电极表面上的这种高阻抗组织的结果而发生。由于其进一步降低了干燥的有效性，所以这使问题加重。第三个因素是在组织治疗电极具有小接触表面面积时，两个因素均强化了，特别是如果该电极是用于切割的钩子时，由于其在用作干燥仪器之前导致电极表面碳化和剥蚀。这些缺点通过使用本发明而克服。特别是，改进的干燥性能在密封静脉或薄壁脉管结构时有用，正如在治疗血管瘤、静脉曲张或者其它脉管异常过程中以及在静脉采集中可以遇到的那样。
然而本发明的另一个优点在于：用电传导溶液或生理溶液如生理盐水对人造空腔灌注具有许多益处。可以防止在该过程中暴露的组织表面脱水，由此提高其存活能力，特别是在愈合过程开始时。将组织碎片、电外科的烟雾和血液从手术部位冲洗掉，从而提高了可视性。这种血行阻断的碎片产生组织反应，其潜在地延缓愈合、增加手术后发炎介体(mediator)产生的疼痛，并且增加伤口感染的危险性。本发明电性能的恒定性通过将手术部位浸渍在电传导液体中而提高，由此在蒸汽中激发电弧所需的电压电势与在电弧电势下的不同气体环境的可变作用相比更为恒定。
本发明还有另一个优点是：为组织结构提供管形入口，当浸渍在电传导液体中时，可以利用干燥功能在热学上改变这些结构。这种入口技术可以用于改变含有胶原蛋白的组织，该组织由于各种原因而变得松弛。支撑韧带的松弛性对于结构的脱垂或下降是常见原因，韧带在没有正确支撑时，通常不正确起作用。这种状况的一个示例是妇女的膀胱颈缩，其中膀胱的关闭机制在压力状态如拉伸、咳嗽或者人体活动下变得无效。膀胱颈和骨盆底部的韧带可以通过穿过会阴开一条管而进入，在这些支撑结构附近创造工作空腔。因此出于改变这些支撑结构的目的，通过利用本发明，这种空腔可以扩展。
附图说明
下文将参照附图通过示例对本发明进行详细描述，其中：
图1是形成本发明电外科系统的一部分的电外科装置的视图；
图2是第一实施例的液体隔绝罩和电极单元的放大的示意性视图；
图3是液体隔绝罩和电极单元的第二实施例的示意性视图；
图4a至4d示出了与第一和第二实施例一起使用的另一个液体输送/排出装置的示意性视图；
图5至7是第一实施例的变型的示意性视图；
图8至9是第二实施例的变型的示意性视图；
图10是示出了与第二实施例的任何形式一起使用的备选密封装置的示意性视图；
图11是与第一实施例或第二实施例一起使用的进一步改型的示意性视图；
图12是说明了在与本发明一起使用双极电极单元过程中处于干燥和汽化模式下发生的电荷阻抗的滞后和耗散射频功率的曲线图；
图13a至13d示出了利用具有浮动管头(tip)的液体输出管的变型装置；
图14示出了另一个改型的装置。
具体实施例
参照附图，图1示出了包括发生器1的电外科装置，其具有输出管座(socket)2，经由连接线4为成机头(handpiece)3形式的仪器提供RF输出。发生器1的启动可以经由线4的控制连接由机头3完成，或者通过脚踏开关机构5完成，如图所示，脚踏开关机构5由脚踏开关连接线6单独连接到发生器1的后部。在所述实施例中，脚踏开关机构5具有两个脚踏开关5a和5b，分别用于选择发生器1的干燥模式和汽化模式。发生器前板具有推动按钮7a和7b，分别用于设定干燥和汽化功率值，这些数值在显示器8中指示。推动按钮9a设置成用于在干燥和汽化模式之间选择的选择装置。电外科装置形成了电外科系统的一部分，其可以用在患者身体表面上或接近表面处对组织结构汽化、切割、造形、干燥、凝结或其它热变型。发生器1在欧洲专利申请96304558.8的说明书中有详细描述。
机头3安装了可拆卸电极单元E，如将在下文描述的诸如电极单元E1至E9。其它可用在本发明的电极单元在我方欧洲专利申请969187681、英国专利申请96003520、欧洲专利申请979003159、欧洲专利申请979261419、欧洲专利申请969187673和欧洲专利中描述，其内容在此引用作为参考。或者，电外科仪器可以包括单体的电极组件形式的连接器来替代机头3。
在图2所示的第一实施例中，电极单元E1可拆卸地固定到机头3(未示出)上。电极单元E1包括轴30，轴30可以是覆盖有绝缘护套30S的传导性(如，金属的)管，电极组件32在轴的远端。在轴30的另一端(未示出)，设置用于将单元E1电连接和机械连接到机头3上的装置。
电极组件32是双极的，具有活性组织治疗电极34，其与回流电极38通过绝缘体36轴向间隔。回流电极38由管30的远端部分构成，该部分未被绝缘片状材料覆盖。在使用中，活性电极32定位成与将要治疗的组织接触或者接近。这意味着，在通常使用中，当电极组件32浸渍在传导性液体介质40中时，回流电极38通过绝缘体36保持与要治疗的组织间隔开，电流路径通过含在罩42中的传导性液体存在两个电极之间。
为了便于在患者身体表面上使用电极组件32，液体罩42固定到身体表面上，通过由凸缘44构成的粘结固定和密封装置形成了液体密封，如图2所示。液体罩42在侧壁中形成了放大窗口46。电极单元E1可以通过形成在液体罩42中的端口48引进液体40中。可以设置不止一个端口48以便同时使用不止一个仪器，或者仪器/内镜组合使用，其中采用了三角剖分技术。
罩42设置有液体流入管50用于经由标准液体注射输送系统(未示出)输送传导性液体(诸如盐水)，该系统通常包括液体袋子和管路支架(tubing set)。有利的是，液体流入管50的出口位于将要治疗的组织表面附近，从而组织碎片和/或血液从手术部位除去。罩42还具有液体流出管52，其设置在罩顶部，从而在使用期间产生的蒸汽气泡优先从罩中消散。为了便于除去蒸汽，流出管52连接到传统真空泵(未示出)上。另外，采用一体的流入和流出泵可以平衡流出和流入。管50和52经由各自的端口50a和52a进入和离开罩42。
如果液体罩42是柔性袋，那么使用真空泵将使该袋塌陷，这显然是不理想的。然而，如果流体罩42是刚性结构，由于真空泵将罩固定到组织表面上，故真空泵是理想的。柔性罩需要正压力。需要在出口处对流动进行限制。在任何情形下，虹吸作用是危险的，其可以引起和真空泵类似的问题。虹吸作用可以通过放气(如透气体膜)而防止。
通过将液体分散输送通过管中的多个孔54，而不是使用单个输送小孔可以获得进一步优点。这样克服了液体流动的影响，当朝向组织治疗电极34时，这些影响增加了超过汽化临界值所需的功率，如图12中点C所示，其各方面在下文有进一步描述。
在第二实施例中，如图3所示，液体罩62位于患者身体部位之上，其中空间64通过切口66在组织上通过手术形成。该空间64可以在作用液体罩62之前使用解剖仪器在内镜显像法下形成，或者可以在充满液体的环境下使用电外科仪器或者基于电极组件32的仪器，或者可以基于两者的组合而形成。有利的是，充满液体的环境，与发生器1和用于本发明的仪器系统结合，允许使用通常用于解剖的组织治疗电极，例如，图3所示的钩状电极34a或针电极。这些电极允许较大的血管密封，大于通常在气体环境中以这种方法治疗的血管密封。这在皮下静脉采集过程中或者作为静脉曲张的治疗一部分密封如图3所示的V处大静脉特别有益。
该实施例的电外科仪器与通过端口70插入罩62中的前列腺切除镜68结合使用。在该示例中，传导性液体(诸如盐水)通过内镜68的液体输送管引进，或者液体可以通过所述的流入管(未示出)输送。在图3所示的示例中，电外科仪器包括电极单元E2，其包括由金属仪器轴30a的未涂覆远端构成的活性电极34a、回流电极38a，轴向分隔两个电极的绝缘体36a。该仪器通过内镜68的工作管插入。另一种方案是，该仪器可以通过在罩62中的单独的端口插入，或者经由第二切口和第二罩(未示出)定位成进入同一组织空腔64。由流出管72的孔74进行液体流出。
当与图1的电外科发生器1结合使用时，图2的电极单元E1(或图3的电极单元E2)可以用在传导性液体介质(盐水)中，依据发生器受控的方式用于通过切割或者汽化除去组织；在患者身体上或身体内，雕刻和造型用于组织的汽化、凝结、干燥或者其它热变性的弯月面，或者用于干燥。图12说明了如何控制发生器1来利用存在于电极单元E1的汽化和凝结模式之间的滞后。因此，假设单元E1的电极组件32浸渍在传导性介质诸如盐水下，在点“O”处有初始载荷阻抗“r”，其大小由电极组件的几何形状和液体介质的电传导性确定。当活性电极34或34a接触组织时，“r”值变化，“r”值越高，电极组件32进入汽化模式的倾向越大。当RF功率施加到电极组件32上时，液体介质加热。假设液体介质是生理盐水(0.9％w/v)，液体介质的传导性温度系数是正的，从而相应的阻抗系数是负的。因此，由于施加了功率，阻抗初始下降并连续下降，功率耗散增加到点“B”，在该点与电极组件32紧密接触的盐水到达沸点。小的蒸汽气泡形成在活性电极34或34a表面上，然后阻抗开始升高。点“B”之后，由于功率消散进一步增加，阻抗的正功率系数占主导，因此功率较小增加带来了阻抗的较大增加。
由于蒸汽空穴由蒸汽气泡形成，故在剩余的电极/盐水界面处功率密度增加。然而，有活性电极34或34a的暴露区域未被蒸汽气泡覆盖，并且这进一步强调了界面，产生了更多蒸汽气泡及更高的功率密度。这是一种失控状态，只有在电极完全被蒸汽包裹时才能产生平衡点。防止失控状态的唯一方式是限制施加的电压，由此防止功率消散进入较高的阻抗载荷。对于给定的变量组，在可以达到该新的平衡(点“C”)之前存在功率的临界值。
因此，曲线在点“B”和“C”之间的区域代表了干燥模式的上限。从点“C”到汽化平衡状态的过渡将遵循发生器1的RF阶段的功率阻抗曲线(图12中虚线所示)。一旦处于汽化平衡状态，阻抗快速的增加到大约1000Ω，其绝对值取决于系统变量。蒸汽空穴由穿过活性电极34或34a和蒸汽/盐水界面之间的蒸汽空穴的排放而维持。大多数功率耗散发生在该空穴内，随后对活性电极34或34a进行加热。能量耗散量和空穴尺寸取决于输出电压。如果输出电压太低，则空穴不会被维持；如果输出电压太高，则电极组件32将被破坏。应该注意的是，如果功率在与点“C”相同的水平输送时，形成的电压将导致电极损坏。对于电极用于汽化的正常的手术点由点“D”表示。该点专门通过电极的阻抗功率特性与汽化电压极限的组合来确定。虚线E表示高于该值则电极破坏的水平是不可避免的功率水平。随着功率降低，阻抗下降，直到点“A”处，蒸汽空穴塌陷，电极组件32转化到汽化模式。在该点，蒸汽空穴中的功率耗散对于维持是不够的，因此活性电极34或34a和盐水之间的直接接触可以再现，阻抗显著下降。在活性电极34或34a处的功率密度也下降，从而盐水温度下降到沸点之下。所以电极组件32处于稳定的干燥模式下。
通过感应穿过发生器1的输出连接出现的峰值RF电压来完成，并且在达到预定峰值电压临界值时通过快速降低输送的输出功率来实现用来达到所需干燥、组织切割和汽化功能的发生器功率控制。至少在干燥模式下，该功率降低显著多于仅将峰值输出电压低于临界值所需的功率。优选功率降低至少50％，以利用参照图12所述的滞后特性。
在使用液体灌注期间，使液体流向电极组件32可以引起点“C”(汽化功率临界值)移动到图12的曲线的右方。因此，围绕活性电极34或34a形成蒸汽空穴所需的功率对于给定的电极组件增加了。因此，理想的是对于给定的电极组件经由液体流入管50或内镜68的工作管分散液体流。
图4a至4d示出了用于液体输送和流出管的另一种装置。图4a和4b示出了用于图2的液体输送管45不同终端，这些终端设置成在手术部位附近分散液体流，从而汽化功率临界值对于给定的电极构型没有显著增加。液体输送管45除了具有图2所示的几个入口孔54之外，可以具有单个孔54a(如图4a所示)，或者可以是具有远端骨架结构的倾斜有孔管80，其条杆(bars)82设置用来发散液流。
图4c示出了图3所示装置的改型，其中液体输送经由液体输送管45a，而不是通过内镜68，并且液体和/或蒸汽经由液体流出管52a除去。液体输送管45a延伸进入外科手术形成的空腔64中，并且通过夹子84或类似装置连接到内镜68上。或者，该装置可以在不需要内镜时改型，在该情形下，管45a可以夹持到先进入空腔64中的任何其它仪器上。在该实施例中示出的活性电极34b由线圈结构构成，其在对较大块状组织(如图T所示)汽化时是特别有利的。
图4d示出了图4c装置的改型，其中液体流出管52a延伸进入外科手术形成的空腔64中，从而蒸汽和液体可以从手术部位通过流出管的远端的孔86排出。该结构在水平方向工作时或者当空腔的远端位于最上方时特别有利，由此避免了蒸汽在空腔中的累积。
图5至7示出了外科手术过程的具体示例，该过程可以用图2所示的实施例进行。图5示出了液体罩92的改型形式的剖面，该液体罩92通过与罩一体形成的凸缘96密封到表皮层94。罩92围绕形成在真皮100上的表皮层94中的肿瘤98。肿瘤98完全浸渍在传导性液体如盐水102中，传导性液体经由液体输送管104供应到罩92的内部，液体输送管在其远端具有多个孔106。液体流出管108设置设置在罩92顶部用于除去液体和/或蒸汽。电外科仪器E3可经由罩92中的端口110插入罩中。电外科仪器E3具有横向线圈结构形式的活性电极34c。在使用中，使用活性电极34c将肿瘤98经汽化逐渐除去。
图5所示的装置可以通过结合电外科仪器而改型，其可以用来方便地切除肿瘤98的一块，用来进行病理检验。
图6示出了围绕皮肤表面的液体罩112，其在表皮皮肤疾患的治疗过程中造型，或者用于使用擦皮法技术除去皱纹。在此，电外科仪器E4经由端口114引入罩112中。仪器E4的远端部分相对仪器主体轴基本上完全成直角，并且具有双极电极组件32，双极电极组件32包括横向线圈形式的活性电极34d。具有这种活性电极的双极电极组件在我方欧洲专利申请97926141.9的说明书中有详细描述。活性电极34d安装在陶瓷绝缘体36的切口部分36a上，从而相对于仪器E4的远端部分的轴线侧向面对。传导性液体(诸如盐水)116经由液体流动管118引入罩112中，液体流动管在其远端部分具有孔120。液体和/或蒸汽可以经由液体流出管122离开罩112。
图7示出了液体罩132，其围绕在将要治疗的慢性 溃烂肿瘤134区域的皮肤表面。电外科电极E5可以经由端口136插入罩132中。传导性液体(诸如盐水)138经由在其远端具有孔142的液体流入管140引进罩132中。液体流出管144用于除去液体和/或蒸汽。电外科仪器E5包括双极电极组件32，其具有由多个针状细线构成的活性电极34e。如图所示，活性电极34e可以用来在慢性溃烂肿瘤134中产生一系列穿刺损伤或者通道146。形成这些损伤146的目的是激励血管新生(angineogenesis)，从而形成了更多的脉管床(vascular bed)用于移植或用于其它矫正技术。可以采用另一种电极几何形状来清除这些溃烂肿瘤，并且其它外科手术过程对于本领域中的普通技术人员是显而易见的。
图8和9示出了外科手术过程的具体示例，其可以用图3的实施例来进行，就是说，在外科手术形成的空腔64围绕手术部位的地方进行。图8示出了围绕着通向空腔64的切口66的液体罩152。附图示出了皮肤的真皮层154，其通过皮下管156进入而促进胶原蛋白纤维的热变性。电外科仪器E6通过液体罩152引进管156中，该仪器的末端部分相对于仪器主体的轴基本上成直角弯曲，并且具有横向线圈结构形式的活性电极34f。仪器E6的轴是有韧性的，以允许将活性电极34f施加到真皮154的深侧。传导性液体(诸如盐水)158通过液体罩152经由在其远端具有孔160的液体流入管158引进到手术部位。还提供了液体流出管162。仪器E6可以通过施加活性电极34f激发处于干燥模式下的发生器1(该图中未示出)而用于热变性。
图9示出了液体罩172，其围绕着外科手术形成的空腔174，空腔通过会阴176进入生殖隔膜和骨盆底部178中。在该实施例中，内镜180用于引导电外科仪器E7进入空腔174中。内镜180通过端口182插入，端口182形成在液体罩172中，患者一般处于进行膀胱石切除术的姿势。在通过矫正膀胱颈缩治疗女性压力整体失禁时，骨盆底部178和其它含有筋膜结构的胶原蛋白可以使用仪器E7的电极结构与发生器1的干燥输出(图9种未示出)相结合来改型(加紧)。外科手术的空间可以先天和后天延伸，以形成结构的一致变化，从而膀胱颈184在方向186上升高。同样的，与肌肉插入到骨头有关的腱的结构、关节支撑结构或者身体的韧带可以在重复拉伤、衰退变化或其它伤害之后治疗，如图10所示的装置所示范出的。传导性液体(诸如盐水)经由液体罩172通过内镜180的内部管施加到手术部位。液体经由液体流出管188离开罩172。
图10说明了由大致管状件构成的液体罩192的改进形式，其具有密封凸缘194。可充盈的球体196安装在液体罩192上，并且可以用于在皮肤表面198和密封凸缘194之间施加压力。患者身体的韧带结构200(诸如膝盖的侧韧带)可以通过电外科仪器E8治疗，该仪器经由内镜202引进韧带结构邻近的外科手术形成的空腔64中。传导性液体(诸如盐水)通过内镜202的工作管引进空腔64中。形成有内镜/仪器和液体控制端口204，其还可以包括液体输送管。液体经由安装在端口204中的液体流出管206出去。在使用中，一旦装置通过皮肤198上的切口208定位，球体196使用充气管(未示出)用液体或气体充盈。另一种方案是，密封凸缘194可以构成用于围绕外科手术空腔64的孔密封的第二球体。电外科仪器E8包括具有线圈结构的活性电极34g。
图11说明了通过传统单极电外科仪器(如E9)来利用本发明的装置。该仪器E9可以通过液体罩212中的端口214插入。该实施例的仪器E9可在外科手术过程中用在皮肤表面上或患者身体内人造空腔中。因而，罩212(图11只示出了其一部分)可以为先前描述的任何类型。然而，即使该仪器E9本身为单极仪器，也可通过如下方法用在双极构型中，即：将回流电极216安装在薄套筒218的远端上，薄套筒218固定到仪器的轴上，从而在回流电极和活性电极34h之间维持固定的关系，其在此由剪刀装置构成。传导性液体(诸如盐水)220通过液体流入管(未示出)引进罩212中。同样的，设置液体流出管(未示出)用于除去传导性液体220。回流电极216通过线222和连接器224电连接到发生器1的双极电外科输出的一侧上(在该图中未示出)。该仪器E9的单极连接器支柱224连接到发生器的另一侧。在使用中，发生器可以在干燥模式下激发，以形成电场图形226，从而活性电极34h可以在双极模式下用于凝结或干燥组织。在该实施例中不能使用发生器的汽化或切割输出。
本发明的另一新方面是使用带浮动管头的液体流出管，如图13a至13d所示。在这些图形中的每一个中，液体罩232包括液体流出管234，其管头234a由弹性材料制成或者结合了弹性材料，从而管头飘浮在罩内的电传导液体(诸如盐水)236中，在罩的顶部“空气空间”内具有管入口。用此方法，管头飘浮到由汽化产生的气体容易除去的区域中。
本发明的另一新方面(如图14所示)在于：通过采用与液体罩(只示出了其基底244)相切的将液体流入管(未示出)可以产生旋转液体流。由箭头A表示的该旋转液体流，使得由电外科仪器E10产生的组织碎片从中心治疗区向外抛去。罩的基底244构造成捕获该碎片。罩基底244具有隆起246来捕获碎片并防止碎片返回到手术部位。
为了便于肉眼可以看到手术部位，每个液体罩42、62、92、112、132、152、172、192、212和222可以由半透明或透明材料制成。
很显然的是，可以根据上述实施例进行多种改型。特别是，各液体罩可以包括可透气体膜部分，以允许汽化的组织从中脱离。另外，在液体罩中可以有热保护装置来防止由功率流动导致的温度升高。
Claims (30)
1.一种电外科系统，包括：射频发生器、电外科仪器和液体罩，所述发生器具有射频输出，用于在浸渍在电传导液体中时将功率输送到电外科仪器上；电外科仪器在其远端具有电极组件，所述电极组件包括组织治疗电极和回流电极，回流电极以在使用中确定传导性液体路径的方式与组织治疗电极轴向间隔开，所述传导性液体路径使组织治疗电极和回流电极之间的电回路接通，其中，液体罩适用于围绕患者皮肤上的手术部位或者切口，所述手术部位或切口通向患者身体内外科手术形成的空腔，其中液体罩包括用于对患者组织密封的密封装置，并且所述液体罩包括至少一个端口，电外科仪器可以通过所述端口插入，并且电传导液体可以通过所述端口进入和/或离开罩。
2.如权利要求1所述的电外科系统，其特征在于，所述液体罩设置有入口，电外科仪器可以通过该入口插入。
3.如权利要求1或2所述的电外科仪器，其特征在于，所述液体罩设置有端口装置，用于向液体罩供应电传导液体以及从液体罩除去所述液体。
4.如权利要求3所述的系统，其特征在于，所述液体罩设置有液体流入管和液体流出管，各管与各自的液体罩端口相连。
5.如权利要求4所述的系统，其特征在于，所述液体流入管在其远端部分设置有多个孔。
6.如权利要求2所述的系统，其特征在于，所述入口适用于容纳内镜，在使用中所述电外科仪器可通过内镜插入。
7.如权利要求6所述的系统，其特征在于，所述液体罩设置有端口，电传导液体可以通过该端口从罩中除去，在内镜中的工作管构成了用于向液体罩内部输送电传导液体的管。
8.如权利要求2至6任一项所述的系统，其特征在于，所述液体罩设置有窗口，外科医生可以通过该窗口看见围绕着组织治疗电极的区域。
9.如权利要求8所述的系统，其特征在于，所述窗口是放大窗口。
10.如权利要求1至9任一项所述的系统，其特征在于，所述电外科仪器是单极仪器，其在远端具有单个组织治疗电极，在使用中位于组织治疗电极附近的金属卡圈构成回流电极，金属卡圈和组织治疗电极连接到发生器上。
11.如权利要求1至10任一项所述的系统，其特征在于，所述液体罩覆盖了围绕着手术部位或切口的皮肤区域，该区域基本上大于手术部位或切口区域，由此含在液体罩中的电传导液体量足够大，以确保其热容量对于从正在治疗的组织上除去热量是有效的。
12.如权利要求1至11任一项所述的系统，其特征在于，所述密封装置由设置在液体罩上的向外延伸的凸缘构成。
13.如权利要求12所述的系统，其特征在于，所述凸缘与液体罩一体形成。
14.一种用在电外科过程中的液体罩装置，所述装置包括半透明的柔性网件，在其周边具有密封凸缘用于形成对患者皮肤的不透液体的密封，由此使得组织能够在大致不透液体的密封物中治疗，所述密封物由患者皮肤和柔性网件形成，并且在网件中至少第一孔能够将电外科仪器引进到密封物中，而同时保持大致不透液体密封的完整性。
15.如权利要求14所述的液体密封物装置，其特征在于，还包括能向密封物内部提供电传导液体的第二孔。
16.如权利要求15所述的液体密封物装置，其特征在于，还包括能从密封物内部除去废物的第三孔。
17.如权利要求16所述的液体密封物装置，其特征在于，还包括液体流出管，其从第三孔延伸进密封物中，流出管在电传导液体中是飘浮的。
18.一种使用电外科系统治疗组织的方法，所述电外科系统包括：电外科发生器，适用于产生第一和第二输出端子之间的射频振荡电压输出；电外科仪器，具有连接到第一发生器输出端子上的活性组织治疗电极；液体输送装置，用于将电传导液体输送到将要治疗的组织；以及连接到第二发生器输出端子上的回流电极，所述方法包括如下步骤：
以大致不透液体的方式封闭空间，将要治疗的组织位于所述空间中，并且至少活性电极位于所述空间中；
操作液体输送装置，用电传导液体至少部分地填充空间；
操作发生器，以在活性电极和回流电极之间施加射频电压，并且使用电传导液体使活性电极和回流电极之间的传导路径的至少一部分接通；以及
在将要治疗的组织附近控制活性电极。
19.如权利要求18所述的系统，其特征在于，还包括将回流电极定位在所述空间中的步骤。
20.如权利要求19所述的系统，其特征在于，所述电外科仪器包括轴，活性电极和回流电极位于轴远端，所述方法还包括使轴的近端从空间伸出及通过移动轴的近端控制活性电极的步骤。
21.如权利要求18所述的方法，其特征在于，所述电传导液体连续供应到空间中，并且所述方法还包括从空间内除去废物的步骤。
22.如权利要求18所述的方法，其特征在于，所述空间通过柔性封闭件封闭，柔性封闭件形成了对患者皮肤的密封，所述方法还包括降低空间内的压力到低于空间紧邻外部的空气压力水平。
23.如权利要求18所述的方法，其特征在于，所述空间通过柔性封闭件封闭，柔性封闭件形成了对患者皮肤的密封，所述方法还包括将该柔性封闭件粘结固定到患者皮肤上的步骤。
24.如权利要求18所述的方法，其特征在于，所述封闭步骤使得所述空间封闭了表皮层的区域。
25.如权利要求24所述的方法，其特征在于，控制所述活性电极使获得下述至少一个方面：皮肤患处的治疗；肿瘤的除去；擦皮法；皱纹减少；皱纹去除；日光角化症的治疗；基底细胞癌的治疗。
26.如权利要求18至23任一项所述的方法，其特征在于，所述封闭步骤使得空间封闭了将要治疗的组织所在的空腔。
27.如权利要求26所述的方法，其特征在于，所述空腔是自然体腔。
28.如权利要求26或27所述的方法，其特征在于，控制所述活性电极使得获得下述至少一个方面：胶原蛋白纤维的热变性；主质和间质(mesanchymal)肿瘤的治疗。
29.如权利要求28所述的方法，其特征在于，进行胶原蛋白纤维的热变性来矫正膀胱颈缩。
30.如权利要求28所述的方法，其特征在于，进行胶原蛋白纤维的热变性来治疗韧带或腱。
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| CN101489623B (zh) * | 2006-07-24 | 2013-07-10 | Med-El电气医疗器械有限公司 | 带有流体储器的可植入神经刺激电极 |
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| CN102665615B (zh) * | 2009-09-22 | 2015-08-19 | 奥林巴斯株式会社 | 空间确保装置 |
| CN111110345A (zh) * | 2012-09-20 | 2020-05-08 | 赤克邦外科有限公司 | 刺激装置适配器 |
| CN111110345B (zh) * | 2012-09-20 | 2024-03-15 | 赤克邦外科有限公司 | 刺激装置适配器 |
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| CN108366822A (zh) * | 2015-08-21 | 2018-08-03 | 艾凡诺医疗公司 | 经皮动静脉造瘘的系统与方法 |
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| CN106510838B (zh) * | 2015-09-10 | 2020-06-30 | 爱尔博电子医疗仪器股份有限公司 | 用于大面积粘膜消融的消融装置 |
| CN106510838A (zh) * | 2015-09-10 | 2017-03-22 | 爱尔博电子医疗仪器股份有限公司 | 用于大面积粘膜消融的消融装置 |
| CN113116508A (zh) * | 2019-12-30 | 2021-07-16 | 北京术锐技术有限公司 | 一种双极密封手术工具头 |
| CN113116508B (zh) * | 2019-12-30 | 2023-10-20 | 北京术锐机器人股份有限公司 | 一种双极密封手术工具头 |
Also Published As
| Publication number | Publication date |
|---|---|
| WO2000041638A1 (en) | 2000-07-20 |
| EP1139895A1 (en) | 2001-10-10 |
| AU1991000A (en) | 2000-08-01 |
| GB9900964D0 (en) | 1999-03-10 |
| US6336926B1 (en) | 2002-01-08 |
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