CN100362969C - Electrosurgical Instruments - Google Patents
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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
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Abstract
Description
技术领域technical field
本发明涉及例如外科手术刀片(scalpel blade)的双极电外科切割装置(electrosurgical cutting device),以及外科系统,包括电外科信号发生器(electrosurgical generator)和双极电外科切割装置。这样的系统通常用于外科治疗中的生物组织切割(the cutting of tissue),大多数通常用在“锁眼”或微创手术(minimally invasive surgery),但也用在“开放”手术(“open”surgery)。The present invention relates to bipolar electrosurgical cutting devices, such as surgical blades, and surgical systems, including electrosurgical generators and bipolar electrosurgical cutting devices. Such systems are commonly used in surgical procedures for the cutting of tissue, most often in "keyhole" or minimally invasive surgery, but also in "open" surgery ("open surgery"). "surgery).
电外科切割装置分为两个种类,单极和双极。在单极装置中,射频(RF)信号提供给用于切除目标点生物组织的活性电极,通过一块接地垫完成一个电路,该接地垫通常是一块大面积垫子,附着在病人身上远离目标点的某一位置上。相反,在双极形配置中,活性电极和回路电极两者均在该切割装置上,而电流常常经由其间形成的电弧从活性电极流向回路电极。Electrosurgical cutting devices fall into two categories, monopolar and bipolar. In monopolar devices, a radio frequency (RF) signal is supplied to an active electrode used to ablate biological tissue at the target point, completing an electrical circuit through a ground pad, usually a large area pad, attached to the patient's body away from the target point. in a certain position. In contrast, in a bipolar configuration, both the active electrode and the return electrode are on the cutting device, and current often flows from the active electrode to the return electrode via an arc formed therebetween.
相关申请对照Related application comparison
双极RF切割装置的一个早期例子是出版在Roos上的US4706667,在该例子中,回路或“中性”电极设置在活性电极向后的一个位置。给出切割面积或电性电极的细节,并且据说中性电极垂直地与活性电极间隔5到15毫米。在包括US3970088,US3987795和US4043342的一系列专利中,莫里森(Morrison)描述了具有“一个半象限差”电极结构的切割/凝结装置。据说这些装置是单极和双极装置间的一种交叉(a cross),带有切割装置上能运行的回路电极,但其面积较佳应比切割电极大3和50倍之间。在一个例子中(US3970088),用多孔渗水的电绝缘层覆盖活性电极,使活性电极与待处理的生物组织隔开,并在该电极与生物组织之间产生电弧。据说该绝缘层的厚度应在0.125和0.25毫米之间(0.005和0.01英寸)An early example of a bipolar RF cutting device is US4706667 published in Roos, in which the return or "neutral" electrode is placed in a position behind the active electrode. Details of the cut area or electrodes are given, and it is said that the neutral electrode is vertically spaced from the active electrode by 5 to 15 mm. In a series of patents including US3970088, US3987795 and US4043342, Morrison describes a cutting/coagulation device having a "one half quadrant differential" electrode configuration. These devices are said to be a cross between monopolar and bipolar devices, with the return electrode operational on the cutting device, but preferably with an area between 3 and 50 times larger than the cutting electrode. In one example (US3970088), an active electrode is covered with a porous, electrically insulating layer, which separates the active electrode from the biological tissue to be treated, and an electric arc is generated between the electrode and the biological tissue. This insulation is said to be between 0.125 and 0.25mm (0.005 and 0.01 inches) thick
在另一个系列专利(包括US4674498,US4850353,US4862890和US4958539)中,Stasz提议各种刀片设计。这些刀片设计成电极之间具有相当小的间隙,以使当RF信号施加到刀片时,能在它们之间产生电弧,该电弧切割生物组织(tissue)。因为将电弧设计成在电极之间产生,隔离电极的绝缘材料的典型厚度在0.025和0.075毫米(0.001和0.003英寸)之间。In another series of patents (including US4674498, US4850353, US4862890 and US4958539), Stasz proposes various blade designs. These blades are designed with relatively small gaps between the electrodes so that when an RF signal is applied to the blades, an arc can be generated between them that cuts biological tissue. Because the arc is designed to be generated between the electrodes, the typical thickness of the insulating material separating the electrodes is between 0.025 and 0.075 millimeters (0.001 and 0.003 inches).
发明概要Summary of the invention
本发明探索提供一种双极刀片,是对先前技术的一种改进。因此,提供一种电外科系统,该系统包括:双极刀片;固定刀片的手柄;以及电外科信号发生器,用于将射频电压信号供给刀片,该刀片包括第一和第二电极,及隔开电极的电绝缘体间隔,该间隔在0.25毫米和3.0毫米之间,电外科信号发生器适合于将射频电压信号供给刀片,该射频电压信号含有基本上恒定的峰值电压值。峰值电压值和电极间的间隔之间的关系是这样的,以使电极间的电场强度在0.1伏/微米和2.0伏/微米之间,第一电极具有与第二电极不同的特性,以使第一电极变成活性电极,而使第二电极变成回路电极。The present invention seeks to provide a bipolar blade which is an improvement over the prior art. Accordingly, there is provided an electrosurgical system comprising: a bipolar blade; a handle for securing the blade; and an electrosurgical signal generator for supplying a radio frequency voltage signal to the blade, the blade including first and second electrodes, and a septum The electrical insulators of the electrodes are spaced between 0.25 mm and 3.0 mm, and the electrosurgical signal generator is adapted to supply a radio frequency voltage signal to the blade, the radio frequency voltage signal having a substantially constant peak voltage value. The relationship between the peak voltage value and the spacing between the electrodes is such that the electric field strength between the electrodes is between 0.1 V/μm and 2.0 V/μm, and the first electrode has different characteristics from the second electrode so that The first electrode becomes the active electrode, leaving the second electrode to become the return electrode.
关于术语“刀刃,”,这里意指:包括设计成能使活性切割电极和回路电极两者都能进入由器械切开的切口内的所有装置(P)2-19~24。不需要该切割装置仅具有切割轴向切口的能力,的确下面将显示:本发明的实施例能按横向除去生物组织的能力。With respect to the term "blade," it is meant here to include all devices (P) 2-19-24 designed to enable both the active cutting electrode and the return electrode to enter the incision made by the instrument. It is not required that the cutting device have only the ability to cut axial incisions, indeed, as will be shown below, embodiments of the present invention have the ability to remove biological tissue laterally.
本发明第一个重要功能是,仔细地控制电极间的间隔和它们间的电场强度,以使在没有生物组织时,电极之间存在直接的电弧。为说明的目的,电极间的间隔按电极间最短的电通路来测量。这样,即使电极与另一个相邻,使它们间的直线距离小于0.25毫米,如果隔离电极的绝缘体是这样的,使该条直线不可用作导电通路,那么,电极间的“间隔”是电极间最短的可用导电通路。电极间的电场强度较佳地应在0.15伏/微米和1.5伏/微米之间,并典型地在0.2伏/微米和1.5微米之间。在一种较佳配置中,第一和第二电极间的间隔在0.25毫米和1.0毫米之间,而电极间的电场强度在0.33伏/微米和1.1伏/微米之间。较佳地,该电场强度是这样的,使第一和第二电极间的峰值电压小于750伏。这保证该电场强度足以在第一电极和生物组织之间产生电弧,但不会直接在第一和第二电极之间产生电弧。The first important function of the present invention is to carefully control the spacing between the electrodes and the electric field strength between them so that in the absence of biological tissue, a direct arc exists between the electrodes. For purposes of illustration, the spacing between electrodes is measured as the shortest electrical path between the electrodes. Thus, even if the electrodes are adjacent to each other such that the straight line distance between them is less than 0.25 mm, if the insulator separating the electrodes is such that the line cannot be used as a conductive path, then the "space" between the electrodes is the distance between the electrodes The shortest available conductive path. The electric field strength between the electrodes should preferably be between 0.15 volts/micron and 1.5 volts/micron, and typically between 0.2 volts/micron and 1.5 microns. In a preferred configuration, the separation between the first and second electrodes is between 0.25 mm and 1.0 mm, and the electric field strength between the electrodes is between 0.33 V/micron and 1.1 V/micron. Preferably, the electric field strength is such that the peak voltage across the first and second electrodes is less than 750 volts. This ensures that the electric field is strong enough to create an arc between the first electrode and the biological tissue, but not directly between the first and second electrodes.
然而,即使能防止在电极之间的直接电弧,如果两个电极的设计相类似,还存在一个电位问题。在双极切割装置中,电极中的仅一个电极呈现为对生物组织是高电位(并变为“活性”电极),而剩余的电极实际上呈现为是与生物组织相同的电位(变为“回路”电极)。在第一和第二电极相似的地方,哪个电极变成活性是一个环境问题。如果该装置在与生物组织接触之前就激活,先接触生物组织的电极将通常变为回路电极,而另一个电极变为活性电极。这意味着,在某些情况中,一个电极是活性电极,而在其他时间,另一个电极是活性电极。这不仅会使外科医生难以控制该装置(因为不能肯定切割操作实际上会发生什么位置),而且很可能任何一个特定电极在某段时间将变为活性电极。However, even if direct arcing between the electrodes can be prevented, there is a potential problem if the two electrodes are similarly designed. In a bipolar cutting device, only one of the electrodes is presented at a high potential to biological tissue (and becomes the "active" electrode), while the remaining electrode is actually presented at the same potential as biological tissue (and becomes an "active" electrode). loop" electrode). Where the first and second electrodes are similar, which electrode becomes active is a matter of circumstance. If the device is activated prior to contact with the biological tissue, the electrode that first contacts the biological tissue will generally become the return electrode and the other electrode will become the active electrode. This means that in some cases one electrode is the active electrode and at other times the other electrode is the active electrode. Not only would this make it difficult for the surgeon to control the device (because there is no certainty where the cutting operation will actually occur), but it is likely that any one particular electrode will become the active electrode at some point.
当一个电极是活性电极时,在它的表面积聚了浓缩物,当电极继续为活性电极时不存在什么问题,但它会使该电极不能适合用作为回路电极。这样,在应用两个相似电极的情况中,很可能因为每个电极在某段时间变为活性电极,而在其他时间变为回路电极,在两个电极上积聚的浓缩物将降低该器械的性能。因此,本发明提供第一电极,其特性与第二电极的特性不同,以使一个电极永久地呈现为活性电极的角色。Concentrate builds up on the surface of an electrode when it is active, which is not a problem while the electrode continues to be active, but it makes the electrode unsuitable for use as a return electrode. Thus, in cases where two similar electrodes are used, it is likely that, as each electrode becomes the active electrode at some times and the return electrode at other times, the build-up of concentrate on both electrodes will reduce the performance of the device. performance. Accordingly, the present invention provides a first electrode whose characteristics differ from those of a second electrode such that one electrode permanently assumes the role of the active electrode.
与第二电极不同的第一电极特性便利地包括电极的横截面面积,该第一电极的横截面面积实际上充分地小于第二电极。这有助于保证第一电极与生物组织接触时具有相当高的初始阻抗,而面积相当大的第二电极在与生物组织接触时具有相当低的初始阻抗。这种配置有助于使第一电极变成活性电极而第二电极变成回路电极。The different properties of the first electrode than the second electrode conveniently include a cross-sectional area of the electrode which is substantially substantially smaller than the second electrode. This helps to ensure that the first electrode has a relatively high initial impedance when in contact with biological tissue, while the relatively large second electrode has a relatively low initial impedance when in contact with biological tissue. This configuration facilitates making the first electrode the active electrode and the second electrode the return electrode.
与第二电极不同的第一电极特性替代或附加地包括电极的导热率,第一电极的导热率充分地低于第二电极。除了初始阻抗外,阻抗的上升速率是影响电极变为活性电极的一个因素。该阻抗将随生物组织的干燥而上升,而电极的温度将影响该干燥的速率。通过选择低导热率的电极材料,因为传离能传送能量的电极部分的热量较少,使电极的温度上升较快。这保证相当快的干燥速率,引起阻抗相当快的上升,并保证第一电极维持为活性电极。The property of the first electrode which differs from the second electrode alternatively or additionally comprises a thermal conductivity of the electrode which is substantially lower than that of the second electrode. In addition to the initial impedance, the rate of rise in impedance is a factor that affects an electrode becoming an active electrode. This impedance will rise as the biological tissue dries, and the temperature of the electrodes will affect the rate of this drying. By selecting an electrode material with low thermal conductivity, the temperature of the electrode rises faster because less heat is transferred away from the portion of the electrode where energy can be transferred. This ensures a relatively fast drying rate, causes a relatively fast rise in impedance, and ensures that the first electrode remains the active electrode.
与第二电极不同的第一电极特性可进一步包括电极的热容量,第一电极的热容量充分地低于第二电极。如前所述,低的热容量有助于将第一电极的温度保持在相当高的位置,保证它维持为活性电极。The different properties of the first electrode than the second electrode may further include a heat capacity of the electrode, the heat capacity of the first electrode being substantially lower than that of the second electrode. As previously mentioned, the low heat capacity helps to keep the temperature of the first electrode relatively high, ensuring that it remains an active electrode.
按照本发明又第一方面,提供一种电外科系统,该系统包括:双极刀片;固定所述刀片的手柄;及电外科信号发生器,用于给刀片提供射频压电信号,该刀片包括第一和第二电极,及将电极隔开的电绝缘体间隔,该间隔在0.25毫米和1.0毫米之间,而电外科信号发生器适合于将峰值电压值基本恒定的射频电压信号供给刀片,该峰值电压值分别在250伏和600伏之间,第一电极具有与第二电极不同的特性,以使第一电极变为活性电极,而第二电极变为回路电极。According to yet another first aspect of the present invention, there is provided an electrosurgical system comprising: a bipolar blade; a handle for securing said blade; and an electrosurgical signal generator for providing a radio frequency piezoelectric signal to the blade, the blade comprising The first and second electrodes, and the electrical insulator separating the electrodes are spaced between 0.25 mm and 1.0 mm, and the electrosurgical signal generator is adapted to supply a radio frequency voltage signal having a substantially constant peak voltage value to the blade, the The peak voltage values are between 250 volts and 600 volts respectively, and the first electrode has a different characteristic than the second electrode so that the first electrode becomes the active electrode and the second electrode becomes the return electrode.
给出一个特殊的电极隔离,最理想的是不管负载条件的变化,该信号发生器传送相同的峰值电压。否则,刀片的重负载可能使它停止工作(否则,因为负载阻抗接近源阻抗,电压可能减半),同时光负载可能导致电压过冲以及直接在电极之间产生电弧。Given a particular electrode isolation, it is ideal that the signal generator deliver the same peak voltage regardless of changing load conditions. Otherwise, a heavy load on the blade could stop it (otherwise, the voltage could be halved because the load impedance is close to the source impedance), while a light load could cause voltage overshoot and arcing directly between the electrodes.
本发明也属于双极刀片,包括第一和第二电极以及隔开电极的电绝缘体间隔,第一电极具有与第二电极不同的特性,以使第一电极变为活性电极,而第二电极变为回路电极,电极间的间隔在0.25毫米和1.0毫米之间,这样当电极与生物组织接触并且电外科切割电压施加在它们之间时,不会直接在电极之间产生电弧,还提供了用于保证第二电极的温度不会上升到超过摄氏70度的装置。The invention also pertains to bipolar blades comprising first and second electrodes and an electrical insulator space separating the electrodes, the first electrode having different properties than the second electrode so that the first electrode becomes the active electrode and the second electrode becomes a return electrode with a spacing between 0.25mm and 1.0mm so that when the electrodes are in contact with biological tissue and an electrosurgical cutting voltage is applied between them, no arcing occurs directly between the electrodes, also providing Means for ensuring that the temperature of the second electrode does not rise above 70°C.
又保证,第二电极不会变为活性电极,重要的是保证第二电极的温度不会上升到超过摄氏70度,在该温度,生物组织会开始粘贴到电极上。用于保证第二电极的温度不会上升到超过摄氏70度的装置便利地包括使从第一电极传递到第二电极的热量减少到最小的装置。一种达到该目的的方法是保证第一电极是由导热率相当差的一种材料构成,较佳地该材料的导热率应小于20W/m.K。通过使第一电极变为差的热导体,热量不会有效地从电极的激活点传递到第二电极,因此有助于防止第二电极温度的上升。Also to ensure that the second electrode does not become an active electrode, it is important to ensure that the temperature of the second electrode does not rise above 70 degrees Celsius, at which temperature biological tissue will start to stick to the electrode. The means for ensuring that the temperature of the second electrode does not rise above 70 degrees Celsius conveniently includes means for minimizing heat transfer from the first electrode to the second electrode. One way to achieve this is to ensure that the first electrode is made of a material with a relatively poor thermal conductivity, preferably the material should have a thermal conductivity of less than 20 W/m.K. By making the first electrode a poor thermal conductor, heat is not effectively transferred from the active point of the electrode to the second electrode, thus helping to prevent the temperature rise of the second electrode.
选择地或附加地,通过使用导热率相当差的一种材料构成电绝缘体来隔开这两个电极,阻止热量从第一电极传递给第二电极,较佳地,该材料的导热率应小于40W/m.K。这又有助于防止在第一电极产生的热量传递给第二电极。Alternatively or additionally, the transfer of heat from the first electrode to the second electrode is prevented by separating the two electrodes by constituting an electrical insulator of a material having a relatively poor thermal conductivity, preferably a material with a thermal conductivity less than 40W/m.K. This in turn helps prevent heat generated at the first electrode from being transferred to the second electrode.
阻止热量传递的另一种方法是将第一电极按间断方式安装到电绝缘体上。Another way to prevent heat transfer is to mount the first electrode in intermittent fashion to the electrical insulator.
较佳地,第一电极应在一个或多个点接触位置安装到电绝缘体上,和/或在第一电极上打有多个小孔,以减少与电绝缘体接触的百分比。Preferably, the first electrode should be mounted to the electrical insulator at one or more point contact locations, and/or have a plurality of small holes punched in the first electrode to reduce the percentage of contact with the electrical insulator.
用作第一电极的一种较佳材料是钽。当钽用作活性电极时,它快速地变成覆盖着一层氧化材料。这钽氧化物是一种差的电导体,有助于第一电极对生物组织保持高阻状态,并维持为活性电极。A preferred material for the first electrode is tantalum. When tantalum is used as the active electrode, it rapidly becomes covered with an oxide material. This tantalum oxide is a poor conductor of electricity, which helps the first electrode maintain a high resistance state to biological tissue and remain an active electrode.
有助于保证第二电极的温度不会上升到超过摄氏70度的另一种方法是使传离第二电极的热量达到最大。这样使从第一电极传递到第二电极的热量在第二电极的温度快速上升之前快速地从第二电极传离出去。一种达到该目的的方法是由一种导热率相当高的材料构成第二电极,较佳地,该材料的导热率应大于150W/m.K。Another way to help ensure that the temperature of the second electrode does not rise above 70 degrees Celsius is to maximize the heat transfer away from the second electrode. This allows heat transferred from the first electrode to the second electrode to be rapidly transferred away from the second electrode before the temperature of the second electrode rises rapidly. One way to achieve this is to form the second electrode from a material with a relatively high thermal conductivity, preferably the material should have a thermal conductivity greater than 150 W/m.K.
第二电极可以便利地配置有附加的冷却装置,以便从那里移走热量,例如安装在第二电极上的热管,或强迫冷却液沿与第二电极接触的途径流动。不论应用哪一种方法,在使用中可取的是第一和第二电极之间的温度差至少为摄氏50度,并较佳地应在摄氏100度和200度之间。The second electrode may conveniently be provided with additional cooling means to remove heat therefrom, such as heat pipes mounted on the second electrode, or forcing cooling fluid along a path in contact with the second electrode. Whichever method is used, it is desirable in use that the temperature difference between the first and second electrodes be at least 50°C, and preferably should be between 100°C and 200°C.
较佳地应另外提供适用于凝结生物组织的第三电极。这个凝结电极便利地安装到第二电极,其间含有附加电绝缘体。必需保证凝结电极的温度上升到太高的位置,因此,如果将凝结电极安装到第二电极(那是按照本技术设计的,是良好的热导体),较佳应安排以使热量容易传过附加电绝缘体。这可以通过用导热率相当高的一种材料构成附加绝缘体来实现,或更典型地,如果附加绝缘体不是良好的热导体,通过保证该附加绝缘体相当地薄,通常不超过约50微米,也可以实现。在这种方法中,跨过附加绝缘体的热传递大于5mW/mm2.K。A third electrode suitable for coagulating biological tissue should preferably be additionally provided. This coagulation electrode is conveniently mounted to a second electrode with an additional electrical insulator in between. It is necessary to ensure that the temperature of the condensation electrode rises too high, so if the condensation electrode is installed to the second electrode (which is designed according to the technology and is a good thermal conductor), it should preferably be arranged so that heat can easily pass through Additional electrical insulators. This can be accomplished by forming the additional insulation from a material with a relatively high thermal conductivity, or more typically, if the additional insulation is not a good conductor of heat, by ensuring that the additional insulation is relatively thin, usually no more than about 50 microns. accomplish. In this approach, the heat transfer across the additional insulator is greater than 5 mW/mm 2 .K.
在一种配置中,第二和第三电极在绝缘衬底上形成为导电电极。这样,这样,当用带有第一电极的刀片用于切割生物组织时,第二和第三电极两者起着回路电极作用。当该刀片用于凝结生物组织时,凝结RF信号施加在第二和第三电极之间。In one configuration, the second and third electrodes are formed as conductive electrodes on an insulating substrate. Thus, when the blade with the first electrode is used for cutting biological tissue, both the second and third electrodes function as return electrodes. When the blade is used to coagulate biological tissue, a coagulation RF signal is applied between the second and third electrodes.
按照本发明的又一方面,提供一种双极刀片,该刀片包括:第一和第电极以及分隔电极的电绝缘体间隔,第一电极具有与第二电极不同的特性,以使第一电极变为活性电极,而使第二电极变为回路电极,电极间的间隔应在0.25毫米和1.0毫米之间,这样当电极与生物组织接触以及电外科切割电压施加在它们之间时,不会直接在电极之间产生电弧,另外提供第三电极,适合于凝结生物组织,由附加绝缘体将第三电极与第二电极隔开。According to a further aspect of the present invention there is provided a bipolar blade comprising: first and second electrodes and an electrical insulator space separating the electrodes, the first electrode having a different characteristic than the second electrode such that the first electrode becomes For the active electrode, and the second electrode becomes the return electrode, the interval between the electrodes should be between 0.25 mm and 1.0 mm, so that when the electrodes are in contact with the biological tissue and the electrosurgical cutting voltage is applied between them, there will be no direct contact between them. An electric arc is generated between the electrodes, and a third electrode, suitable for coagulating biological tissue, is additionally provided, separated from the second electrode by an additional insulator.
便利地以并排排列提供第二和第三电极,它们之间含有附加绝缘体。替代地,将第二和第三电极配置为夹层结构中的电极层,它们之间含有附加绝缘体。在一种便利配置中,将第一,第二和第三电极配置为夹层结构中的电极层,它们之间含有绝缘体层。The second and third electrodes are conveniently provided in a side-by-side arrangement with an additional insulator between them. Alternatively, the second and third electrodes are configured as electrode layers in a sandwich structure with an additional insulator between them. In one convenient arrangement, the first, second and third electrodes are arranged as electrode layers in a sandwich structure with an insulator layer therebetween.
在一种配置中,第二和第三电极中的第一个电极配备有切掉部分(cut-out),而第二和第三电极中的另一个电极配备有突出部分。较佳地,一个电极的切掉部分可以容纳另一电极的突出部分,典型地使该突出部分嵌入该电极,围绕所述切掉部分。In one configuration, a first of the second and third electrodes is provided with a cut-out and the other of the second and third electrodes is provided with a protrusion. Preferably, the cut-out portion of one electrode accommodates the protruding portion of the other electrode, typically with the protruding portion embedded in the electrode, surrounding said cut-out portion.
替代地,将第一,第二和第三电极配置为夹层结构中的电极层,第一电极位于该结构的中间,在每个电极之间还在绝缘体层。在一种配置中,第二和第三电极的横截面基本上是半圆形,而第一电极稍微突出第二和第三电极的周边。Alternatively, the first, second and third electrodes are configured as electrode layers in a sandwich structure with the first electrode in the middle of the structure and an insulator layer between each electrode. In one configuration, the cross-section of the second and third electrodes is substantially semicircular, while the first electrode protrudes slightly beyond the perimeter of the second and third electrodes.
按照本发明的最后一个方面,提供在目标点切割生物组织的一种方法,该方法包括:提供一种双极刀片,该刀片包括第一和第二电极以及分隔电极的电绝缘体间隔,第一电极具有与第二电极不同的特性,以使第一电极变为活性电极,而使第二电极变为回路电极;将刀片引导到相对于目标点的位置,以使第二电极在目标点与生物组织接触,而使第一电极与之邻近;给刀片提供电外科切割电压,电外科电压和第一和第二电极间的间隔是这样的,以使不会在第一和第二电极之间的空气中产生电弧,但能在第一和目标点生物组织之间产生电弧,电流经该生物组织流到第二电极;并防止在第二电极积聚热量,以使第二电极的温度不会上升到超过摄氏70度。较佳地,该方法是这样的,以使第一和第二电极两者与目标点的生物组织基本上同时接触。According to a final aspect of the present invention, there is provided a method of cutting biological tissue at a target point, the method comprising: providing a bipolar blade comprising first and second electrodes and an electrical insulator spacer separating the electrodes, the first The electrode has different characteristics than the second electrode so that the first electrode becomes the active electrode and the second electrode becomes the return electrode; the blade is directed to a position relative to the target point so that the second electrode is at the target point in contact with the The biological tissue is contacted so that the first electrode is adjacent thereto; an electrosurgical cutting voltage is provided to the blade, the electrosurgical voltage and the spacing between the first and second electrodes are such that there is no gap between the first and second electrodes Electric arc can be generated in the air between the first and target point biological tissue, and electric current flows to the second electrode through the biological tissue; and prevent the accumulation of heat in the second electrode, so that the temperature of the second electrode is will rise to over 70 degrees Celsius. Preferably, the method is such that both the first and second electrodes contact the biological tissue at the target point substantially simultaneously.
附图简述Brief description of the drawings
将参考附图描述本发明,仅作为例子,在附图中:The invention will be described with reference to the accompanying drawings, by way of example only, in which:
图1是按照本发明构成的电外科系统示意图;Fig. 1 is a schematic diagram of an electrosurgical system constituted according to the present invention;
图2是按照本发明构成的电外科刀片的示意性横截面视图;Figure 2 is a schematic cross-sectional view of an electrosurgical blade constructed in accordance with the present invention;
图3是一幅原理框图,示出图2刀片的横向切割动作;Fig. 3 is a functional block diagram showing the transverse cutting action of Fig. 2 blade;
图4a到4d是按照本发明构成的电外科刀片的替代实施例的示意性横截面视图;4a to 4d are schematic cross-sectional views of an alternative embodiment of an electrosurgical blade constructed in accordance with the present invention;
图5a和5b是按照本发明构成的电外科刀片的示意图,并入有冷却装置;及Figures 5a and 5b are schematic illustrations of electrosurgical blades constructed in accordance with the present invention, incorporating cooling means; and
图6a和6b,和图7到11是按照本发明构成的替代电外科刀片,并入有附加凝结电极。Figures 6a and 6b, and Figures 7 to 11 are alternative electrosurgical blades constructed in accordance with the present invention incorporating additional coagulation electrodes.
发明详述Detailed description of the invention
参考图1,信号发生器10含有输出插座10S,经连接软线14将射频(RF)输出给器械12。从器械12经软线14的连接或通过脚踏开关单元16激活信号发生器10,如所示的,该脚踏开关经脚踏开关连接软线18连接到射频信号发生器的后面。在该描述性实施例中,脚跟开关单元16含有两个脚踏开关16A和16B,用于分别选择信号发生器10的凝结模式和切割模式。射频信号发生器的前面板含有按钮20和22,用于分别设置凝结和切割功率电平,在显示器24上显示这些电平。提供按钮26作为的替代装置,用于凝结和切割模式之间的选择。Referring to FIG. 1 , a
参考图2,器械12包括通常以1所示的刀片,并含有一般平坦的第一电极2,较大的第二电极3,及电绝缘体4,隔开第一和第二电极。第一电极2由不锈钢构成,其导热率为18W/m.K(虽然也可以使用例如镍铬合金的替代材料)。第二电极3由高导热率的材料构成,例如导热率为400W/m.K的铜(替代材料包括银和铝)。第二电极3的表面镀有例如铬合金的双系数和谐材料,或镀有例如镍,金,铂,钯,不锈钢,一氮化钛或钨二氧化硫(tungsten disulphide)的替代的非氧化性材料。电绝缘体4由例如Al2O3的陶瓷材料构成,通常具有30W/m.K的导热率。绝缘体4可以用其他可能的材料,这些材料具有充分低的导热率。这些材料包括:氮化硼,瓷器,块滑石,氧化锆,聚四氟乙稀,加强云母,硅橡胶或例如泡沫陶瓷的其他陶瓷材料或例如以商标MACOR出售的可塑玻璃陶瓷。Referring to Figure 2,
导电引线5连接到第一电极2,而引线6连接到第二电极3。来自信号发生器10的RF输出经引线5和6连接到刀片1,以使具有基本上恒定的峰值电压(通常约为400V)的射频信号出现在第一和第二电极2和3之间。参考图3,当刀片1引导到与目标点的生物组织7接触时,RF电压将在电极和生物组织表面之间产生电弧。因为第一电极2与第二电极3相比,其横截面积较小,并具有较低的热容量和导热率,第一电极将呈现活性电极的角色并在该电极到生物组织7之间将产生电弧。电流将经过生物组织7流到第二电极3,第二电极呈现回路电极的角色。活性电极将切割该生物组织,并且刀片可以移动经过该生物组织。刀片1可以用于切开生物组织7,或可以按图3中的箭头8的方向横向地移动,以除去一层生物组织。A conductive lead 5 is connected to the
在切割期间,在活性电极2将产生相当多的热量,电极的温度可以上升到摄氏100度-250度。然而,由于绝缘体4的导热率较差,只有较少的热量传递到第二电极3。即使热量未传递到第二电极3,铜材料的高导热率意指许多热量传离该电极表面并进入该电极体9。这有助于保证在第一电极2和第二电极3之间维持一个温度差,并且只要有可能,使第二电极的温度唯持低于摄氏70度。这保证,无论何时激活器械12,第二电极2维持为回路电极,并保证该生物组织不会开始粘贴到电极3。During cutting, considerable heat will be generated at the
除了提供导热率相当低的绝缘体4外,其优点是保证第一电极2与绝缘体的接触尽可能地小。在图2中,电极2不是按连续方式(continuous fashion)固定到绝缘体4和电极3,但是通过一般以11所示的一个或多个点的接触针来固定。图4a显示刀片的另一种设计,在该设计中,定型第一电极2,以使它仅在沿它的长度方向间歇地与绝缘体4接触,在区域13,电极从绝缘体14向外定型成弓形。这有助于进一步将从第一电极2经绝缘体4传递到第二电极3的热量减少到最小。图4b显示另一种配置,在该配置中,第一电极上打有许多穿孔15,这些小孔是按网孔格式。再一次,这有助于使第一电极传递到绝缘体4的热量减少到最小。图4c显示另一种配置,在该配置中,在第一电极2和绝缘体4之间有一层附加的波纹电极层17。如上所述,这有助于防止在第一电极2产生的热量传到第二电极3,以便维持它们间的热差。Besides providing the
图4d显示图2刀片的一种变化,在该变化中,将该刀片定型成弯钩19。第一电极2,第二电极3和绝缘体4都是钩状,而该装置的操作基本上如同参考图2描述的。该钩状电极特别适合于分离生物组织,不管是用作无RF激发的冷切除器械,还是用作RF切割器械。当进行操作或切割时,生物组织保留在弯钩19的角20内。FIG. 4d shows a variant of the blade of FIG. 2 in which the blade is shaped as a
无论应用哪一种电极设计,如果从第一电极2传递到第二电极3的热量能传离电极3的生物组织接触表面,这是其优点。在图2的刀片中,第二电极3由大量的铜制成,铜能将热量传离电极尖端。可用如图5a和5b描述的冷却装置进一步加强电极3的功能。在图5a中,第二电极3安装以27所示的热管上。热管27包括中空密封管28,远端29相邻于电极3,而近端30在器械12的手柄内。密封管28的中间含有空腔31,该空腔31容纳例如丙酮或酒精的低沸点温度液体32。使用中,来自电极3的热量使位于密封管远端29的液体32汽化,并然后这蒸汽在密封管的近端30凝结,因为相对于远端29,该近端相对地较冷。这样,热量从电极3的远端传递到其上的近端,从这里,可由器械12的手柄进一步地进行散热。Regardless of which electrode design is used, it is an advantage if the heat transferred from the
图5b显示一种替代配置,在该配置中,用一般以33所示的强迫冷却系统替代图5a的热管。该冷却系统33包括密封管34,又含有远端29和近端30。密封管34包含的同轴内管35,用于确定内腔36和外腔37。在朝密封管远端的内管35上打孔,以使内腔和外腔36和37互相连通。使用中,自含式泵38使冷却液39沿内腔36到远端39,经外腔37返回,以继续重新循环。电极3加热该循环液体,并由该液体将热量带到密封管34的近端30。这样,不管第一电极2温度的上升,使第二电极保持较低的温度。Figure 5b shows an alternative configuration in which the heat pipe of Figure 5a is replaced by a forced cooling system, shown generally at 33. The
剩余的附图显示配备有第三电极40的配置,以允许凝结或干燥生物组织7。在图6a中,示出按图4b结构的刀片1,并用相似的参考数字标明相似的部件。第三电极40在与第一电极2相对一侧安装到第二电极3上,并安装在附加电绝缘体41上。RF信号可以从信号发生器10经引线42施加到第三电极40。绝缘体41由硅橡胶薄层制成,绝缘体41的替代材料包括聚酰胺,PEEK(聚醚醚酮)或PVC(聚氯乙稀)材料。该薄层保证:热量能传过硅橡胶层并且凝结电极40能受益于第二电极3的导热属性。这样,不管由第一电极2先前产生的任何热量,凝结电极40能维持相当低的温度。使用中,如先前描述一样切割生物组织。当希望凝结而不是切割时,将第三电极40放置到与生物组织7接触,并在第二电极3和第三电极40之间施加凝结RF信号。The remaining figures show a configuration equipped with a
图6b显示一种替代实施例,在该实施例中,第二电极3和第三电极40是铝氮化物材料衬底43上的金属化轨道(metallised tracks),如同前面所述,该材料是电绝缘的良好热导体,允许热量传离第二和第三电极。Figure 6b shows an alternative embodiment in which the
图7显示一种配置,在该配置中,第一电极2位于第二和第三电极3和40的中间。电极3和40两者的横截面都为近似半圆形,并形成一般圆柱结构,其中第一电极2从其上的中间区域稍微突出。绝缘层4将第一电极2与第二电极3隔开,并且绝缘层41将第一电极2与第三电极40隔开。当用户打算将该器械用于切割生物组织时,信号发生器10将切割RF信号施加在第一电极2和第二或第三电极3,40中的一个或两者之间。相反地,当用户打算将该器械用于凝结生物组织时,信号发生器10将凝结RF信号施加在第二电极3和第三电极40之间。电极3和40的相当大的表面面积允许有效地凝结生物组织,同时允许切割期间热量的传离,如同先前所述。FIG. 7 shows a configuration in which the
图8显示另一种替代的器械设计,在该设计中,并排地放置第二和第三电极3和40。第一电极2基本上是平坦的,并且绝缘层4将第一电极与该器械另一侧上的第二和第三电极3和40隔开。电极3和40并排排列地放置,其间有绝缘部分41。如前所述,该器械能用第一电极2和第二或第三电极3,40中的一个之间的RF信号切割生物组织,或替代地用第二和第三电极间的RF信号凝结生物组织。Figure 8 shows another alternative device design in which the second and
图9显示另一个实施例,在该实施例中,将第一,第二和第三电极配置为“夹层”排列中的多电极层。第一电极2显示为图9中的顶层,第三电极40为底层,而第二电极3夹在这两层的中间。绝缘层4和41分别用于隔离第一,第二,和第三电极。这种配置给刀片1提供相对厚的刀刃,将它设计成有利于生物组织的凝结。Figure 9 shows another embodiment in which the first, second and third electrodes are arranged as a multi-electrode layer in a "sandwich" arrangement. The
图10显示一种配置,该配置利用该夹层和并排电极结构的功能。电极又按夹层结构配置,图10显示的第一电极2是在顶部而不是在图9所示的顶部。第二电极3又在夹层的中间,由绝缘层4与第一电极隔开。第三电极40示作为图10中的顶部电极,含有一个中间凹口,通过该凹口第二电极3的凸起部分50能够突出。第二和第三电极由绝缘体41隔开,突出部分50的顶表面嵌入第三电极40的顶部。这种配置允许如图10所示的刀片1的侧表面或顶表面用于凝结生物组织。Figure 10 shows a configuration that exploits the functionality of this sandwich and side-by-side electrode structure. The electrodes are again arranged in a sandwich structure, and the
图11显示一种配置,在该配置中,刀片1的末端包括中间的第一电极2,该电极的两侧带有绝缘层4和41。绝缘层4和41的每层分别含有倾斜远端,分别以51和52示出。第二电极安装到绝缘层4,倾斜端51导致将第二电极放置在沿刀片轴从第一电极2向后的一个位置。以相似的方式,第三电极40安装到绝缘体41,倾斜端52也导致第三电极放置在从第一电极2轴向向后的一个位置。倾斜端51和52允许第一电极和第二和第三电极之间0.25毫米的最小间隔(图11中以“x”显示),同时给刀片1维持总体细长外形。第一电极2能嵌入第一和第二绝缘层4和41的末端,或可以稍微从那里突出,如图11所示。如先前所述,通过许多种技术能够减少第一电极的热量传递,这些技术包括将该电极以间歇方式安装到绝缘层上,或在该电极上打有许多小孔以减少热量传递。Figure 11 shows a configuration in which the tip of the
本发明依赖于许多设计参数的仔细选择,包括第一和第二电极之间的间隔,其上施加的电压,为电极和电绝缘体或绝缘体选择的尺寸和材料。这种仔细选择应保证在电极之间没有直接的电弧,仅使一个电极变为活性电极,并通过防止热量传到回路电极或通过传离应当传递到第二电极的热量,使回路电极保持较低的温度。The present invention relies on careful selection of a number of design parameters, including the spacing between the first and second electrodes, the voltage applied thereto, the dimensions and materials chosen for the electrodes and the electrical insulator or insulator. This careful selection should ensure that there is no direct arcing between the electrodes, that only one electrode becomes the active electrode, and that the return electrode remain relatively small by preventing heat from being transferred to the return electrode or by transferring heat that should be transferred to the second electrode. low temperature.
相对冷的回路电极保证对邻近该器械回路电极的生物组织仅受到相当小的热损坏或没有损坏,同时该生物组织有助于将热量传离回路电极。The relatively cool return electrode ensures that there is little or no thermal damage to the biological tissue adjacent to the return electrode of the device, while the biological tissue helps to transfer heat away from the return electrode.
Claims (17)
Applications Claiming Priority (6)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| GBGB0130975.6A GB0130975D0 (en) | 2001-12-27 | 2001-12-27 | A surgical instrument |
| GB0130975.6 | 2001-12-27 | ||
| GB0206207A GB0206207D0 (en) | 2002-03-15 | 2002-03-15 | A surgical instrument |
| GB0206207.3 | 2002-03-15 | ||
| GB0215402A GB0215402D0 (en) | 2002-07-03 | 2002-07-03 | A surgical instrument |
| GB0215402.9 | 2002-07-03 |
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|---|---|
| CN1610526A CN1610526A (en) | 2005-04-27 |
| CN100362969C true CN100362969C (en) | 2008-01-23 |
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| CNB028264274A Expired - Fee Related CN100362969C (en) | 2001-12-27 | 2002-12-23 | Electrosurgical Instruments |
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| EP (1) | EP1458300A1 (en) |
| JP (1) | JP4313205B2 (en) |
| CN (1) | CN100362969C (en) |
| AU (1) | AU2002358220B2 (en) |
| WO (1) | WO2003055402A1 (en) |
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| CN103200892A (en) * | 2010-10-20 | 2013-07-10 | 泰尔茂心血管系统公司 | Treatment tool for surgical use |
| CN103200892B (en) * | 2010-10-20 | 2015-08-26 | 泰尔茂心血管系统公司 | Surgical instrument |
Also Published As
| Publication number | Publication date |
|---|---|
| EP1458300A1 (en) | 2004-09-22 |
| AU2002358220A1 (en) | 2003-07-15 |
| JP4313205B2 (en) | 2009-08-12 |
| WO2003055402A1 (en) | 2003-07-10 |
| AU2002358220B2 (en) | 2008-09-25 |
| JP2005512726A (en) | 2005-05-12 |
| CN1610526A (en) | 2005-04-27 |
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