JP4313205B2 - Surgical instruments - Google Patents

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JP4313205B2
JP4313205B2 JP2003555981A JP2003555981A JP4313205B2 JP 4313205 B2 JP4313205 B2 JP 4313205B2 JP 2003555981 A JP2003555981 A JP 2003555981A JP 2003555981 A JP2003555981 A JP 2003555981A JP 4313205 B2 JP4313205 B2 JP 4313205B2
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electrode
bipolar
scalpel
electrodes
incision
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JP2005512726A (en
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オーウェン ゴーブル，チャールズ
ジョージ マーシャル，マーク
ジュリアン バッチェラー，ケスター
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ジラス メディカル リミティド
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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
    • A61B18/1402—Probes for open surgery
    • 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
    • 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
    • A61B18/1206—Generators therefor
    • A61B2018/1246—Generators therefor characterised by the output polarity
    • A61B2018/126—Generators therefor characterised by the output polarity bipolar
    • 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
    • A61B2018/1412—Blade

Description

本発明は、メスのような二極型電気式外科手術切開用器具、及び電気式外科手術用ジェネレータと二極型電気式外科手術切開用器具とを具備する電気式外科手術用装置に関するものである。そのような装置は、外科的治療、一般的に“キーホール”又は組織を損傷しない外科処置あるいは切開処置における組織の切開に通常使用されている。   The present invention relates to a bipolar electric surgical incision instrument such as a scalpel, and an electric surgical apparatus comprising an electric surgical generator and a bipolar electric surgical incision instrument. is there. Such devices are commonly used for incision of tissue in surgical treatments, generally “keyholes” or surgical or incision procedures that do not damage the tissue.

電気式外科手術切開用器具は、一般に二つのカテゴリーがあって、単極型と二極型とである。単極型器具において、無線周波数（ＲＦ）信号は、対象部位における組織を切開するために使用される活性電極に供給されていて、電気回路は、対象部位から離れている場所において患者に取りつけられた一般に広い面積のパッドであるアース用パッドにより完結している。一方、二極型器具において、活性電極と帰還電極とが切開用器具に提供されていて、電流が活性電極から帰還電極へ流れ、時に両電極間にアークが形成される。   There are generally two categories of electrical surgical incision instruments, unipolar and bipolar. In monopolar instruments, a radio frequency (RF) signal is applied to an active electrode used to dissect tissue at a target site, and the electrical circuit is attached to the patient at a location remote from the target site. In general, it is completed by a grounding pad which is a pad having a large area. On the other hand, in a bipolar instrument, the active electrode and the return electrode are provided to the cutting instrument, and current flows from the active electrode to the return electrode, sometimes creating an arc between the electrodes.

初期における二極型ＲＦ切開用器具は、Roosに交付された特許文献１に開示されていて、帰還あるいは“無極（neutral）”電極は活性電極からセットバックされている。切開用電極及び無極電極の面積は所定のものであって、無極電極は活性電極から５mm−１５mmの間だけ直交的に離間している。一連の特許文献２〜５において、Morrisonは“三極性（sesquipolar）”電極構造体を有している切開用／凝固用器具を開示している。これらの器具が単極型器具と二極型器具との間の中間物と言われ、帰還電極を備えていて、その帰還電極は、切開用器具に担持されているが、切開用電極と比較して好ましくは３−５０培広い面積である。一例（特許文献２）において、活性電極が穴のあいた電気絶縁層でおおわれていて、その電気絶縁層は活性電極を処置すべき組織から隔てていて、かつ電極と組織との間でアークを発生するようになっている。その電気絶縁層は０．１２５−０．２５mm（０．００５−０．０１in）の間の厚さである。   An early bipolar RF incision instrument is disclosed in US Pat. No. 6,057,037 issued to Roos, where the return or “neutral” electrode is set back from the active electrode. The area of the incision electrode and the non-polar electrode is predetermined, and the non-polar electrode is orthogonally separated from the active electrode by 5 mm to 15 mm. In a series of patents 2-5, Morrison discloses an incision / coagulation instrument having a “sesquipolar” electrode structure. These instruments are said to be intermediates between monopolar and bipolar instruments and have a return electrode, which is carried by the lancing device, but compared to the lancing electrode The area is preferably 3-50 times wider. In one example (Patent Document 2), the active electrode is covered with an electrically insulating layer having a hole, the electrical insulating layer separates the active electrode from the tissue to be treated, and an arc is generated between the electrode and the tissue. It is supposed to be. The electrical insulation layer is between 0.125-0.25 mm (0.005-0.01 inches) thick.

別の一連の特許（特許文献５−８）において、Staszは、種々の切開用メスのデザインを提案している。これらは二つの電極間に比較的狭いギャップを備えたデザインとなっていて、ＲＦ信号がメスに作用された場合両電極間にアークが発生するようになっており、アークにより組織の切開がもたらされる。アークは電極間で発生するようになっているので、電極間を隔てる絶縁材料の一般的な厚さは０．０２５−０．０７５mm（０．００１−０．００３in）の間であった。   In another series of patents (Patent Documents 5-8), Stasz proposes various scalpel designs. These are designed with a relatively narrow gap between the two electrodes so that when an RF signal is applied to the scalpel, an arc is generated between the two electrodes, which causes an incision of the tissue. It is. Since arcing occurs between the electrodes, the typical thickness of the insulating material separating the electrodes was between 0.025-0.075 mm (0.001-0.003 in).

米国特許第４７０６６６７号明細書US Pat. No. 4,706,667 米国特許第３９７００８８号明細書U.S. Pat. No. 3,970088 米国特許第３９８７７９５号明細書US Pat. No. 3,987,795 米国特許第４０４３３４２号明細書U.S. Pat. No. 4,043,342 米国特許第４６７４４９８号明細書US Pat. No. 4,674,498 米国特許第４８５０３５３号明細書U.S. Pat. No. 4,850,353 米国特許第４８６２８９０号明細書US Pat. No. 4,862,890 米国特許第４９５８５３９号明細書US Pat. No. 4,958,539

本発明は従来技術よりすぐれた改善した二極型切開用メスを提供することである。従って、二極型切開用メスと、該二極型切開用メスが取りつけられているハンドピースと、該切開用メスに無線周波数電圧を供給するための電気式外科手術用ジェネレータとを具備する電気式外科手術装置が提供されていて；
該切開用メスが、第一電極及び第二電極と、該電極を離間している電気絶縁体とを備えている電気式外科手術装置において；
離間距離が０．２５mm−３．０mmの間であって、該電気式外科手術用ジェネレータが、ほぼ一定のピーク電圧値を有する無線周波数電圧信号を該切開用メスに供給するようになっていて、該ピーク電圧値と、該電極間の該離間距離との間の関係は、該電極間の電界強度が０．１Ｖ／μｍと２．０Ｖ／μｍとの間であるようになっており、該第一電極は該第二電極と異なる特性を有していて、該第一電極が活性電極になり、そして該第二電極が帰還電極となるようになっていることを特徴とする、電気式外科手術装置である。 The present invention is to provide an improved bipolar scalpel which is superior to the prior art. Accordingly, an electrical device comprising a bipolar scalpel, a handpiece to which the bipolar scalpel is attached, and an electric surgical generator for supplying radio frequency voltage to the scalpel. A surgical device is provided;
An electrosurgical device, wherein the scalpel comprises a first electrode and a second electrode, and an electrical insulator separating the electrodes;
A separation distance of between 0.25 mm and 3.0 mm, wherein the electrosurgical generator is adapted to supply a radio frequency voltage signal having a substantially constant peak voltage value to the scalpel. The relationship between the peak voltage value and the separation distance between the electrodes is such that the electric field strength between the electrodes is between 0.1 V / μm and 2.0 V / μm, The first electrode has different characteristics than the second electrode, wherein the first electrode is an active electrode and the second electrode is a return electrode. Type surgical apparatus.

用語“メス”は、活性な切開用電極と帰還電極との両電極が器具により作られた切り口に入るようになっているすべての装置を含んでいることを意味している。切開用器具が軸方向切り口を作ることが可能なだけである必要はなくて、本発明による実施形態は組織を横断方向に除去することが可能であって以下に説明する。   The term “female” is meant to include all devices in which both the active cutting electrode and the return electrode are adapted to enter an incision made by the instrument. It is not necessary for the cutting instrument to only be able to make an axial incision, but embodiments according to the present invention can remove tissue in the transverse direction and will be described below.

本発明における最も重要な特徴は次のとうりである。電極間の間隔とその間の電界強度とは、組織のないところで電極間に直接的なアークがないように周到に制御されている。本明細書の目的のために、電極間の間隔は電極間における電気的最短通路で計測される。したがって、たとえ電極が他の物に隣接していて、電極間の直線距離が０．２５mm未満であるようになっていても、電極を離間している絶縁体がこの直線を伝導パスとして利用できないようにしているなら、電極間の“間隔”は電極間における利用可能な最短導電パスとされる。電極間の電界強度は、好ましくは０．１５Ｖ／μｍと１．５Ｖ／μｍとの間であって、通常０．２Ｖ／μｍと１．５Ｖ／μｍとの間である。好適な装置の一つにおいて、第一及び第二電極間の間隔は０．２５mmと１．０mmの間であって、電界強度は０．３３Ｖ／μｍと１．１Ｖ／μｍとの間である。好ましくは電界強度は、第一及び第二電極間のピーク電圧が７５０Ｖ未満であるようになっている。このことが以下のことを保証していて、電界強度は第一電極と組織との間でアークを発生するのに十分なものであるが、第一電極と第二電極との間で直接的なアークは生じないようになっている。   The most important features in the present invention are as follows. The distance between the electrodes and the electric field strength therebetween are carefully controlled so that there is no direct arc between the electrodes in the absence of tissue. For purposes of this specification, the spacing between electrodes is measured in the shortest electrical path between the electrodes. Therefore, even if the electrodes are adjacent to each other and the linear distance between the electrodes is less than 0.25 mm, the insulator separating the electrodes cannot use this straight line as a conduction path. If so, the “interval” between the electrodes is the shortest conductive path available between the electrodes. The electric field strength between the electrodes is preferably between 0.15 V / μm and 1.5 V / μm, and usually between 0.2 V / μm and 1.5 V / μm. In one preferred device, the spacing between the first and second electrodes is between 0.25 mm and 1.0 mm and the electric field strength is between 0.33 V / μm and 1.1 V / μm. . Preferably, the electric field strength is such that the peak voltage between the first and second electrodes is less than 750V. This ensures that: the electric field strength is sufficient to generate an arc between the first electrode and the tissue, but directly between the first electrode and the second electrode. No arc is generated.

しかしながら、電極間の直接的なアークが防止されても、もし二つの電極が同一デザインであると問題の可能性は残している。二極型切開用メス器具において、一方の電極だけが組織に対して高電圧となっていて（“活性”電極（“active”electrode）となっている）、他方の電極は組織と同様の電圧となっている（“帰還”電極（“return”electrode）となっている）。第一及び第二電極が同一デザインの場合、どちらの電極が活性電極になるかは、環境の問題となってしまう。もし器具が組織に接触する前に作動されると、最初に組織に接触した電極が一般に帰還電極となり、他方が活性電極となる。このことはある環境において一方の電極が活性電極となり、他環境においては他方の電極が活性電極となることを意味している。このことは、外科手術医が器具を制御することを困難にする（どちらで切開処置が行なわれるのかが確かなものではない）だけでなく、いずれの電極もが時に活性電極となりうるようになっている。   However, even if direct arcing between the electrodes is prevented, the problem remains if the two electrodes are of the same design. In a bipolar incision scalpel instrument, only one electrode is at a high voltage relative to the tissue (the “active” electrode) and the other electrode is at the same voltage as the tissue. ("Return" electrode). When the first and second electrodes have the same design, which electrode becomes the active electrode is an environmental issue. If the instrument is activated before contacting the tissue, the first electrode that contacts the tissue will generally be the return electrode and the other will be the active electrode. This means that in one environment one electrode becomes the active electrode and in the other environment the other electrode becomes the active electrode. This not only makes it difficult for the surgeon to control the instrument (which is uncertain in which incision procedure is performed) but also allows any electrode to be the active electrode at times. ing.

電極が活性になる場合、電極の表面に凝縮生成物が蓄積される。このことは、電極が活性電極となっている限り問題はないが、この電極を帰還電極として使用するには不適切なものである。従って、二つの類似の電極を使用する場合、すなわち各々の一方が時に活性電極となり時に帰還電極となる場合、両電極における生成物の蓄積が器具の性能劣化をもたらす。従って、本発明において、提供される装置は、第一電極が第二電極と異なる特性を有していて、一方の電極が活性電極の役割を果すようになっている。   When the electrode becomes active, condensation products accumulate on the surface of the electrode. This is not a problem as long as the electrode is an active electrode, but is inappropriate for use as a return electrode. Thus, when two similar electrodes are used, i.e., one of each is sometimes the active electrode and sometimes the return electrode, product build-up on both electrodes leads to instrument performance degradation. Accordingly, in the present invention, the provided device is such that the first electrode has different characteristics than the second electrode, and one electrode serves as the active electrode.

該第二電極と異なる該第一電極の特性には電極の断面積が含まれていて、該第一電極の断面積は、該第二電極の断面積より相当小さなものである。このことは、（断面積のより小さな）第一電極が組織に接触する際における相対的に大きな初期インピーダンスとなり、一方で相対的に大きな断面積の第二電極が組織に接触する際における相対的に小さな初期インピーダンスとなることを保証している。この構成が第一電極が活性電極となり、かつ第二電極が帰還電極となることを促がしている。   The characteristics of the first electrode different from the second electrode include the cross-sectional area of the electrode, and the cross-sectional area of the first electrode is considerably smaller than the cross-sectional area of the second electrode. This results in a relatively large initial impedance when the first electrode (which has a smaller cross-sectional area) is in contact with the tissue, while the second electrode with a relatively large cross-sectional area is relatively relative when it is in contact with the tissue. Guarantees a small initial impedance. This configuration encourages the first electrode to be the active electrode and the second electrode to be the return electrode.

該第二電極と異なる該第一電極の特性には電極の熱伝導率が含まれていて、該第一電極の熱伝導率は、該第二電極の熱伝導率より相当小さなものである。初期インピーダンスに加えて、インピーダンスの上昇速度は、どちらの電極が活性電極になるかに影響する因子となっている。インピーダンスは組織の乾燥に伴なって上昇し、乾燥速度は電極の温度により影響を受ける。比較的小さな熱伝導率の電極材料を選択することにより、電極の温度は、エネルギが供給されている電極の部分からほとんど熱が伝導されなくても迅速に上昇する。このことは以下のことを保証していて、比較的迅速な乾燥速度が、対応する迅速なインピーダンスの上昇をもたらし、かつ第一電極が活性電極となることを確実なものにしている。   The characteristics of the first electrode different from the second electrode include the thermal conductivity of the electrode, and the thermal conductivity of the first electrode is considerably smaller than the thermal conductivity of the second electrode. In addition to the initial impedance, the rate of increase in impedance is a factor that affects which electrode becomes the active electrode. Impedance increases with tissue desiccation, and the rate of desiccation is affected by electrode temperature. By selecting an electrode material with a relatively low thermal conductivity, the temperature of the electrode rises quickly even if little heat is conducted from the portion of the electrode being energized. This guarantees that the relatively fast drying rate results in a corresponding rapid increase in impedance and ensures that the first electrode becomes the active electrode.

該第二電極と異なる該第一電極の特性には電極の熱容量が含まれていて、該第一電極の熱容量は、第二電極の熱容量より相当小さなものである。前述したように、小さな熱容量は、第一電極における温度を相対的に高いレベルに維持することに役立っていて、第一電極が活性電極にあることを保証している。   The characteristics of the first electrode different from the second electrode include the heat capacity of the electrode, and the heat capacity of the first electrode is considerably smaller than the heat capacity of the second electrode. As previously mentioned, the small heat capacity helps to maintain the temperature at the first electrode at a relatively high level, ensuring that the first electrode is at the active electrode.

本発明におけるさらなる実施形態において、二極型切開用メスと、該切開用メスが取りつけられているハンドピースと、該切開用メスに無線周波数電圧を供給するための電気式外科手術用ジェネレータとを具備する電気式外科手術装置が提供されていて；
該切開用メスが、第一電極及び第二電極と、該電極を離間している電気絶縁体とを備えている電気式外科手術装置において；
離間距離が０．２５mm−１．０mmの間であって、該電気式外科手術用ジェネレータが、ほぼ一定のピーク電圧値を有する無線周波数電圧信号を該切開用メスに供給するようになっていて、該ピーク電圧値は２５０Ｖと６００Ｖとの間であり、該第一電極は該第二電極と異なる特性を有していて、該第一電極が活性電極になり、そして該第二電極が帰路電極となるようになっていることを特徴とする、電気式外科手術装置である。 In a further embodiment of the invention, a bipolar scalpel, a handpiece to which the scalpel is attached, and an electrosurgical generator for supplying radio frequency voltage to the scalpel An electrosurgical device is provided;
An electrosurgical device, wherein the scalpel comprises a first electrode and a second electrode, and an electrical insulator separating the electrodes;
A separation distance between 0.25 mm and 1.0 mm, wherein the electrosurgical generator is adapted to supply a radio frequency voltage signal having a substantially constant peak voltage value to the scalpel. The peak voltage value is between 250V and 600V, the first electrode has different characteristics than the second electrode, the first electrode becomes the active electrode, and the second electrode returns An electrosurgical apparatus characterized by being an electrode.

電極を離間するなら、ジェネレータが負荷変動にもかかわらず同一のピーク電圧を供給することが所望される。そうでないと、メスの高負荷はメスを停止させ（負荷インピーダンスが発生源インピーダンスに近づくので電圧が半減する）、一方でメスの軽負荷は電圧のオーバシュートをもたらし電極間における直接的なアークをもたらす。   If the electrodes are separated, it is desirable for the generator to provide the same peak voltage despite load variations. Otherwise, the high load on the knife will stop the knife (the voltage will be halved as the load impedance approaches the source impedance), while the light load on the knife will cause voltage overshoot and direct arcing between the electrodes. Bring.

本発明は、第一電極及び第二電極と、該電極を離間している電気絶縁体とを具備する二極型切開用メスに関するものであって；
該第一電極が該第二電極と異なる特性を有しており、該第一電極が活性電極になり、そして該第二電極が帰路電極となっている二極型切開用メスにおいて；
該両電極間の離間距離は０．２５mmと１．０mmとの間であって、該両電極が組織と接触して、電気式外科手術用切開電圧が該両極間に作用される場合、アークは該両極間に直接的に発生しないことと、該第二電極の温度が７０℃を越えないことを保証するための手段も備えられていることとを特徴とする、二極型切開用メスである。 The present invention relates to a bipolar scalpel having a first electrode and a second electrode, and an electrical insulator separating the electrodes;
In a bipolar scalpel where the first electrode has different characteristics than the second electrode, the first electrode is the active electrode, and the second electrode is the return electrode;
When the separation distance between the electrodes is between 0.25 mm and 1.0 mm and the electrodes are in contact with tissue and an electrosurgical incision voltage is applied between the electrodes, the arc Is not directly generated between the two electrodes, and means for ensuring that the temperature of the second electrode does not exceed 70 ° C. are also provided. It is.

第二電極が活性電極にならないことを保証するのと同じく、第二電極の温度が７０°、すなわち組織が電極に固着し始める温度を上廻わらないことを保証することも重要である。第二電極の温度が７０℃を上廻らないことを保証するための装置は、第一電極から第二電極への熱の伝達を最小にする手段を便宜的に備えている。これを達成する一つの方法は、第一電極が、好ましくは２０Ｗ／ｍ.ｋ未満の比較的小さな熱伝導率の材料で形成されていることを保証することである。第一電極を小さな熱伝導率の材料で作ることにより、熱は電極の活性部分から第二電極へ効果的に伝達除去されずに、従って第二電極の温度上昇が回避されている。   As well as ensuring that the second electrode does not become the active electrode, it is also important to ensure that the temperature of the second electrode is not above 70 °, ie the temperature at which the tissue begins to stick to the electrode. The apparatus for ensuring that the temperature of the second electrode does not exceed 70 ° C. is conveniently provided with means for minimizing the transfer of heat 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 low thermal conductivity, preferably less than 20 W / m.k. By making the first electrode from a material with low thermal conductivity, heat is not effectively transferred away from the active portion of the electrode to the second electrode, thus avoiding an increase in temperature of the second electrode.

電極を離間する電気絶縁体を、好ましくは４０Ｗ／ｍ.ｋ未満の比較的小さな熱伝導率の材料で作ることにより、熱が第一電極から第二電極へ伝達されることを防止してもよい。このことは、第一電極で発生した熱が第二電極へ伝達することを防止することに役立っている。   Even if the electrical insulator separating the electrodes is made of a material with a relatively low thermal conductivity, preferably less than 40 W / m.k, heat can be prevented from being transferred from the first electrode to the second electrode. Good. This serves to prevent heat generated at the first electrode from being transferred to the second electrode.

熱伝達を防止する他の方法は、該第一電極を該電気絶縁体に不連続的に取りつけることである。好ましくは、該第一電極が、該電気絶縁体に一ヶ所以上の接触位置で取りつけられていること、及び／又は該第一電極は、該電気絶縁体と接触する割合を低減するように複数の穴があけられていることである。   Another way to prevent heat transfer is to discontinuously attach the first electrode to the electrical insulator. Preferably, the first electrode is attached to the electrical insulator at one or more contact positions, and / or the plurality of first electrodes is reduced so as to reduce the rate of contact with the electrical insulator. It is that the hole is made.

第一電極として好適な材料はタンタルである。タンタルを活性電極として使用する場合、タンタルはすぐに酸化材料層で被膜されてしまう。この酸化タンタルは小さな導電性であって、第一電極が組織に対して大きなインピーダンスを維持し、そして活性電極となっていることを保証するのに役立っている。   A suitable material for the first electrode is tantalum. When tantalum is used as the active electrode, tantalum is immediately coated with an oxide material layer. This tantalum oxide is small in conductivity and helps to ensure that the first electrode maintains a large impedance to the tissue and is the active electrode.

該第二電極の温度が７０℃を越えないことを保証するための他の方法は、該第二電極からの熱伝達による熱除去を最大化することである。従って、第一電極から第二電極に達するいずれの熱も、第二電極の温度が上昇する以前に迅速に伝達除去されている。これを達成する一つの方法は、該第二電極を１５０Ｗ／ｍ.ｋより大きな比較的高熱伝導率を備えた材料で形成することである。   Another way to ensure that the temperature of the second electrode does not exceed 70 ° C. is to maximize heat removal by heat transfer from the second electrode. Therefore, any heat reaching the second electrode from the first electrode is quickly transmitted and removed before the temperature of the second electrode rises. One way to achieve this is to form the second electrode from a material with a relatively high thermal conductivity greater than 150 W / m.k.

第二電極が熱を除去するために、第二電極に取りつけられたヒートパイプか、又は第二電極に接触している通路に沿った強制流となっている冷却流体のような、冷却手段を便宜的に備えていてもよい。どの方法が使用されるにしても、使用時における第一電極と第二電極との間の温度差が少なくとも５０℃、好ましくは１００℃と２００℃との間であることが適切である。   In order for the second electrode to remove heat, a cooling means, such as a heat pipe attached to the second electrode or a cooling fluid that is forced flow along the passage in contact with the second electrode, is used. It may be provided for convenience. Whatever method is used, it is appropriate that the temperature difference between the first electrode and the second electrode in use is at least 50 ° C., preferably between 100 ° C. and 200 ° C.

好ましくは、組織を凝固するための第三電極をさらに備えられている。この凝固用電極が第二電極に取りつけられて、両電極の間にさらなる電気絶縁体が備えられている。凝固用電極の温度が著しく高温にならないことを保証することが必要であって、もし凝固用電極が（本発明の教示によれば熱伝導率の良い）第二電極に取りつけられるなら、熱がさらなる電気絶縁体を通過して容易に伝達されるような配列とすることが好ましい。このことは、さらなる絶縁体を比較的高熱伝導率の材料で作ることにより達成されてもよいし、あるいは、一般的なことであるが、もしさらなる絶縁体の熱伝導率が悪い場合、さらなる絶縁体の厚さが一般に約５０μｍを越えない比較的薄くすることを保証することにより達成されてもよい。この方法で、さらなる絶縁体を通過する熱は５mW／ｍ2.ｋより大きくなる。 Preferably, a third electrode for coagulating the tissue is further provided. The coagulation electrode is attached to the second electrode and a further electrical insulator is provided between the electrodes. It is necessary to ensure that the temperature of the coagulation electrode does not rise significantly and if the coagulation electrode is attached to a second electrode (which has good thermal conductivity according to the teachings of the present invention) Preferably, the arrangement is such that it is easily transmitted through the further electrical insulator. This may be achieved by making the further insulator from a material with a relatively high thermal conductivity, or, as a general rule, if the thermal conductivity of the further insulator is poor, further insulation It may be achieved by ensuring that the body thickness is relatively thin, generally not exceeding about 50 μm. In this way, the heat passing through the further insulator is greater than 5 mW / m 2 .k.

一つの装置において、第二及び第三電極が絶縁基板における導電電極として形成されている。第一電極を用いてメスが組織を切開するために使用される場合、第二及び第三の両電極は帰還電極として作動する。メスが組織を凝固するために使用される場合、凝固用ＲＦ信号は第二及び第三電極の間に作用される。   In one device, the second and third electrodes are formed as conductive electrodes on the insulating substrate. When the scalpel is used to cut tissue with the first electrode, both the second and third electrodes act as return electrodes. When a scalpel is used to coagulate tissue, a coagulation RF signal is applied between the second and third electrodes.

本発明のさらなる実施形態において、第一電極及び第二電極と、該電極を離間している電気絶縁体とを具備する二極型切開用メスが提供されていて；
該第一電極が該第二電極と異なる特性を有しており、該第一電極が活性電極になり、そして該第二電極が帰路電極となっている二極型切開用メスにおいて；
該両電極間の離間距離は０．２５mmと１．０mmとの間であって、該両電極が組織と接触して、電気式外科手術用切開電圧が該両極間に作用される場合、アークは該両極間に直接的に発生しないことと、組織を凝固するようになっている第三電極がさらに備えられていて、該第三電極はさらなる絶縁体により該第二電極から隔てられていることとを特徴とする、二極型切開用メスである。 In a further embodiment of the present invention, there is provided a bipolar scalpel comprising a first electrode and a second electrode and an electrical insulator separating the electrodes;
In a bipolar scalpel where the first electrode has different characteristics than the second electrode, the first electrode is the active electrode, and the second electrode is the return electrode;
When the separation distance between the electrodes is between 0.25 mm and 1.0 mm and the electrodes are in contact with tissue and an electrosurgical incision voltage is applied between the electrodes, the arc Is further provided with a third electrode that is not directly generated between the electrodes and is adapted to coagulate tissue, the third electrode being separated from the second electrode by a further insulator. A bipolar incision scalpel characterized by the above.

該第二及び第三電極が並行配列となっていて、両電極の間に該さらなる絶縁体を備えている。代りに第二及び第三電極がサンドイッチ構造体の層となっていて、両電極の間にさらなる絶縁体を備えている。該第一、第二及び第三電極がサンドイッチ構造体の層となっていて、電極間に絶縁体層を備えている。   The second and third electrodes are arranged in parallel, with the further insulator between the electrodes. Instead, the second and third electrodes are sandwiched layers, with a further insulator between the electrodes. The first, second and third electrodes form a sandwich structure layer, and an insulator layer is provided between the electrodes.

該第二及び第三電極の一方が切欠き部分を備えていて、該第二及び第三電極の他方が突起部分を備えている。好ましくは、該一方の電極の該切欠き部分が、該電極の他方の該突起を収容していて、該突起部分が、該切欠き部分を囲んでいる該電極と同一高さになるようになっている。   One of the second and third electrodes has a cutout portion, and the other of the second and third electrodes has a protruding portion. Preferably, the cutout portion of the one electrode accommodates the other projection of the electrode, and the projection portion is flush with the electrode surrounding the cutout portion. It has become.

代りに、該第一、第二及び第三電極がサンドイッチ構造体の層となっていて、該第一電極が中段になっていて、該電極各々の間に絶縁体の層がある。一つの構成において、第二及び第三電極がほぼ半円形の断面であって、該第一電極が、該第二及び第三電極の外周縁から僅かに突出している。   Instead, the first, second and third electrodes are sandwiched layers, the first electrode is in the middle, and there is an insulator layer between each of the electrodes. In one configuration, the second and third electrodes have a substantially semi-circular cross section, and the first electrode slightly protrudes from the outer periphery of the second and third electrodes.

本発明のさらなる実施の形態において、対象部位における組織の切開方法が提供されていて：
第一電極及び第二電極と、該電極を離間している電気絶縁体とを具備する二極型切開用メスを準備する段階であって、該第一電極が該第二電極と異なる特性を有しており、該第一電極が活性電極になり、そして該第二電極が帰路電極となっている二極型切開用メスを準備する段階と；該第二電極が該対象部位において組織と接触するように、かつ該第一電極はそこに隣接するように、該切開用メスを該対象部位に位置決めする段階と；該切開用メスに電気式外科手術切開用電圧を供給する段階とを含んでいる対象部位における組織の切開方法において、
該電気式手術切開用電圧と、該第一及び第二電極間の該離間距離とは、該第一及び第二電極間における空中においてアークが発生しないけれど、該第一電極と該対象部位における組織との間でアークが発生するようになっていて、電流が該組織を通過して該第二電極へ流れ、該第二電極における熱の蓄積を防止することで該第二電極の温度が７０℃を越えて上昇しないようになっていることを特徴とする、対象部位における組織の切開方法である。 In a further embodiment of the present invention, a method for dissecting tissue at a target site is provided:
A step of preparing a bipolar scalpel having a first electrode and a second electrode, and an electrical insulator separating the electrodes, wherein the first electrode has different characteristics from the second electrode. Providing a bipolar scalpel having the first electrode as an active electrode and the second electrode as a return electrode; and Positioning the scalpel at the target site such that the scalpel is in contact and the first electrode is adjacent thereto; and supplying an electrosurgical incision voltage to the scalpel. In a tissue incision method in a target site including:
The electric surgical incision voltage and the separation distance between the first and second electrodes are not generated in the air between the first and second electrodes, but the first electrode and the target site An arc is generated with the tissue, and current flows through the tissue to the second electrode to prevent heat accumulation in the second electrode, thereby preventing the temperature of the second electrode. A tissue incision method at a target site, characterized in that it does not rise above 70 ° C.

添付図面を参照して、例を用いて本発明を説明する。   The invention will now be described by way of example with reference to the accompanying drawings.

図１において、ジェネレータ１０は、無線周波数（ＲＦ）出力を接続コード１４を介して器具１２に提供する出力ソケット１０Ｓを有している。ジェネレータ１０の作動は、コード１４における結線を介して、器具１２から、又は足踏スィッチ接続コード１８を介してジェネレータの背面と接続された足踏スィッチ１６により実行される。例示の実施態様において、足踏スィッチユニット１６は、ジェネレータ１０の凝固モードと切開モードとをそれぞれ選択する二つの足踏スィッチ１６Ａと１６Ｂとを有している。ジェネレータの前面パネルは、それぞれ凝固出力レベルと切開出力レベルとを設定するプッシュボタン２０と２２とを有していて、それらの出力レベルはディスプレ２４に表示される。プッシュボタン２６は、凝固モードと切開モードとの間を選択する切替手段として備えられている。   In FIG. 1, the generator 10 has an output socket 10 </ b> S that provides radio frequency (RF) output to the instrument 12 via a connection cord 14. The operation of the generator 10 is performed by a foot switch 16 connected to the back of the generator via the connection in the cord 14, from the instrument 12, or via the foot switch connection cord 18. In the illustrated embodiment, the foot switch unit 16 has two foot switches 16A and 16B that select the coagulation mode and the incision mode of the generator 10, respectively. The front panel of the generator has push buttons 20 and 22 for setting the coagulation output level and the incision output level, respectively, and these output levels are displayed on the display 24. The push button 26 is provided as switching means for selecting between the coagulation mode and the incision mode.

図２において、器具１２が全体として符号１で示めすメスを備えていて、そのメス１は、ほぼフラットな第一電極２と、より大きな第二電極３と、第一電極と第二電極とを隔てる電気絶縁体４を含んでいる。第一電極２は１８Ｗ／ｍ.ｋの熱伝導率を有するステンレス鋼で形成されている（ニクロム合金のような別の材料が使用されてもよい）。第二電極３は、４００Ｗ／ｍ.ｋの熱伝導率を有する銅のような高熱伝導性材料から形成されている（銀あるいはアルミニウムを含む別の材料でもよい）。第二電極３の表面は、クロム合金のような生物学的適合性材料か、又はニッケル、金、白金、パラジウム、ステンレス鋼、窒化チタン又は二硫化タングステンのような別の非酸化性材料によりメッキされている。電気絶縁体４は、一般に３０Ｗ／ｍ.ｋの熱伝導率を有するＡｌ2Ｏ3のようなセラミック材料で形成されている。電気絶縁体４として熱伝導率の小さな適切な他の適切な材料が利用可能である。これらには、窒化ホウ素、磁器、ステアタイト、酸化ジルコニウム、ポリ四フッ化エチレン、強化雲母、シリコンラバー、又は発泡セラミックあるいは商標ＭＡＣＯＲとして販売されている成形可能なガラスセラミックのような他のセラミック材料が含まれる。 In FIG. 2, the instrument 12 is generally provided with a knife indicated by reference numeral 1, and the knife 1 includes a substantially flat first electrode 2, a larger second electrode 3, a first electrode and a second electrode. An electrical insulator 4 is included. The first electrode 2 is formed of stainless steel having a thermal conductivity of 18 W / m.k (another material such as a nichrome alloy may be used). The second electrode 3 is formed from a high thermal conductivity material such as copper having a thermal conductivity of 400 W / m.k (may be another material including silver or aluminum). The surface of the second electrode 3 is plated with a biocompatible material such as a chromium alloy or another non-oxidizing material such as nickel, gold, platinum, palladium, stainless steel, titanium nitride or tungsten disulfide. Has been. The electrical insulator 4 is generally made of a ceramic material such as Al 2 O 3 having a thermal conductivity of 30 W / m · k. Any other suitable material having a low thermal conductivity can be used as the electrical insulator 4. These include boron nitride, porcelain, steatite, zirconium oxide, polytetrafluoroethylene, reinforced mica, silicon rubber, or other ceramic materials such as foam ceramic or moldable glass ceramic sold under the trademark MACOR Is included.

リード線５が第一電極２と接続されていて、リード線６が第二電極３と接続されている。ジェネレータ１０からのＲＦ出力はリード線５及び６を介してメス１と接続されていて、従ってほぼ一定のピーク電圧（一般に約４００Ｖ）を有する無線周波数が第一電極２と第二電極３との間に出現するようになっている。図３において、メス１が組織７の対象部位に接触されると、ＲＦ電圧は一方の電極と組織表面との間でアークを発生する。第一電極２は、第二電極３と比較して断面積が小さく、かつ熱容量及び熱伝導率が小さいので、第一電極が活性電極の役割を果し、アークはこの第一電極から組織７へ発生する。電流は、組織７から第二電極３へ流れ、この第二電極が帰還電極の役割を果している。組織の切開が活性電極において生じる場合、メスが組織を通って移動する。メス１は組織７における切開に使用されてもよいし、あるいは組織層を除去するために、図３において矢印８の方向に横断的に移動されてもよい。   The lead wire 5 is connected to the first electrode 2, and the lead wire 6 is connected to the second electrode 3. The RF output from the generator 10 is connected to the female 1 via leads 5 and 6 so that a radio frequency having a substantially constant peak voltage (generally about 400V) is generated between the first electrode 2 and the second electrode 3. Appears in between. In FIG. 3, when the knife 1 is brought into contact with a target site of the tissue 7, the RF voltage generates an arc between one electrode and the tissue surface. Since the first electrode 2 has a smaller cross-sectional area and a smaller heat capacity and thermal conductivity than the second electrode 3, the first electrode serves as an active electrode, and the arc is formed from the first electrode to the structure 7. To occur. The current flows from the tissue 7 to the second electrode 3, and this second electrode serves as a return electrode. When a tissue incision occurs at the active electrode, the scalpel moves through the tissue. The scalpel 1 may be used for an incision in the tissue 7 or may be moved transversely in the direction of the arrow 8 in FIG. 3 to remove the tissue layer.

切開中に、活性電極２において多量の熱が発生され、電極の温度は１００−２５０℃に上昇するかも知れない。しかしながら、絶縁体４の熱伝導率が小さいので、多量の熱が第二電極３へ伝達されることはない。熱が第二電極３に達した場合でも、銅材料の熱伝導率が大きいので、熱は電極表面から電極のボデー９の中へ伝導で除去される。このことは、第一電極２と第二電極３との間に温度差が保たれることを保証し、かつ第二電極３の温度を可能な限り長時間７０°以下に維持することを保証するのに役立っている。このことは、器具１２が作動されている場合はいつでも、第二電極３が帰還電極となっていることを保証し、かつ組織は第二電極３と固着しないことを保証している。   During the incision, a large amount of heat is generated at the active electrode 2 and the temperature of the electrode may rise to 100-250 ° C. However, since the thermal conductivity of the insulator 4 is small, a large amount of heat is not transferred to the second electrode 3. Even when the heat reaches the second electrode 3, the heat conductivity of the copper material is large, so that the heat is removed by conduction from the electrode surface into the electrode body 9. This guarantees that a temperature difference is maintained between the first electrode 2 and the second electrode 3, and also ensures that the temperature of the second electrode 3 is kept below 70 ° for as long as possible. It is useful to do. This ensures that the second electrode 3 is the return electrode whenever the instrument 12 is activated and that the tissue does not stick to the second electrode 3.

比較的低熱伝導率の絶縁体４を備えることに加えて、第一電極２を可能な限り絶縁体４に接触させないことを確実にすることが利点のあることである。図２において、第一電極２は絶縁体４と第二電極３とに連続的に取りつけられていなくて、一つ以上の点接触ピン１１により取りつけられている。図４ａは別の構造のメスを示めしていて、第一電極２は、その全長にわたって絶縁体４と断続的に接触するように形状化されていて、電極が絶縁体４から外向きに弓なりに曲がっている領域１３を備えている。このことが、第一電極２から絶縁体４を通って第二電極３への熱の伝達を最小化するのに役立っている。図４ｂはさらに別の構造を示めしていて、第一電極２は、メッシュ形状となっている多数の穴１５を備えている。このことが第一電極２から絶縁体４への熱の伝達を最小化している。図４ｃはもう一つの構造を示めしていて、第一電極２と絶縁体４との間に設置された波形電極層７を有している。このことは、第一電極２を発生された熱が第二電極３へ達することを防止していて、両者の間に温度差が維持されるようになっている。   In addition to providing the insulator 4 with relatively low thermal conductivity, it is advantageous to ensure that the first electrode 2 is not in contact with the insulator 4 as much as possible. In FIG. 2, the first electrode 2 is not continuously attached to the insulator 4 and the second electrode 3, but is attached by one or more point contact pins 11. FIG. 4a shows an alternative scalpel, in which the first electrode 2 is shaped so as to intermittently contact the insulator 4 over its entire length so that the electrode bows outward from the insulator 4. A region 13 that is bent is provided. This helps to minimize heat transfer from the first electrode 2 through the insulator 4 to the second electrode 3. FIG. 4b shows a further structure, in which the first electrode 2 is provided with a number of holes 15 in the form of a mesh. This minimizes heat transfer from the first electrode 2 to the insulator 4. FIG. 4 c shows another structure, having a corrugated electrode layer 7 placed between the first electrode 2 and the insulator 4. This prevents the heat generated by the first electrode 2 from reaching the second electrode 3 so that a temperature difference is maintained between them.

図４ｄは図２におけるメスの変形であって、メスがフック形状１９となっている。第一電極２、第二電極３及び絶縁体４すべてがフック形状であって、装置の操作は図２を参照して説明したものとほぼ同様である。フック状電極は、特に組織を分離することに適切なものであって、ＲＦなしの常温での切除器具として使用されるか、又はＲＦ切開器具として使用される。処置あるいは切開にあたって、組織はフック１９の角度２０で保持することができる。   FIG. 4 d is a modification of the knife in FIG. 2, and the knife has a hook shape 19. The first electrode 2, the second electrode 3, and the insulator 4 are all hook-shaped, and the operation of the apparatus is almost the same as that described with reference to FIG. The hook-like electrode is particularly suitable for tissue separation and is used as a normal temperature ablation instrument without RF or as an RF dissection instrument. During the procedure or incision, the tissue can be held at an angle 20 of the hook 19.

いずれの電極の構造が採用されても、第一電極２から第二電極３へ通過してゆく熱が第二電極３の表面に接触している組織から伝達除去されることは利点のあることである。図２のメスにおいて、第二電極３は、電極の先端から熱を伝導で除去する比較的大質量の銅により構成されている。第二電極３の機能は、図５ａ及び５ｂに示めす冷却手段を採用することによりさらに強化されている。図５ａにおいて、第二電極３はヒートパイプ２７に取りつけられている。ヒートパイプ２７は、閉じた中空パイプ２８を備えていて、その中空チューブ２８は、第二電極と隣接している末端部２９と、器具１２のハンドピース内部の基端部３０とを有している。中空チューブ２８は、アセトンあるいはアルコールのような沸騰温度の低い液体３２の入っているキャビティ３１を有している。使用時において、第二電極３からの熱は、チューブの末端部２９において液体３２を蒸発させ、この蒸気はチューブの基端部において凝縮する。というのは、基端部は末端部２９に対して相対的に低温であるからである。このようにして、熱は第二電極３の末端部から基端部へ伝達され、そこから器具１２のハンドピースを介して放散される。   Whichever electrode structure is adopted, it is advantageous that the heat passing from the first electrode 2 to the second electrode 3 is transferred and removed from the tissue in contact with the surface of the second electrode 3. It is. In the scalpel of FIG. 2, the second electrode 3 is made of a relatively large mass of copper that removes heat from the tip of the electrode by conduction. The function of the second electrode 3 is further enhanced by employing the cooling means shown in FIGS. 5a and 5b. In FIG. 5 a, the second electrode 3 is attached to the heat pipe 27. The heat pipe 27 comprises a closed hollow pipe 28 having a distal end 29 adjacent to the second electrode and a proximal end 30 inside the handpiece of the instrument 12. Yes. The hollow tube 28 has a cavity 31 containing a liquid 32 having a low boiling temperature such as acetone or alcohol. In use, heat from the second electrode 3 evaporates the liquid 32 at the distal end 29 of the tube, and this vapor condenses at the proximal end of the tube. This is because the proximal end portion is relatively cold with respect to the distal end portion 29. In this way, heat is transferred from the distal end of the second electrode 3 to the proximal end, where it is dissipated through the handpiece of the instrument 12.

図５ｂは別の装置であって、図５ａにおけるヒートパイプが強制冷却装置３３に置き換えられている。冷却装置３３は、チューブ３４、末端部２９及び基端部３０を備えている。チューブ３４が、内部ルーメン３６と外部ルーメン３７とを形成している同軸の内管３５を含んでいる。内管３５はチューブの末端部へ向けて穴があけられていて、従って内部ルーメン３６と外部ルーメン３７とはお互いに連通している。使用時において、自給式ポンプ（self-contained pump）３８により、冷却流体３９が内部ルーメン３６から末端部２９へ流れ、外部ルーメン３７を介してもどり連続的に循環するようになっている。循環流体は第二電極３により加熱され、熱は流体によりチューブ３４の基端部３０へ送られる。このようにして、第一電極２における高温にもかかわらず、第二電極３は低温に維持される。   FIG. 5 b shows another device, in which the heat pipe in FIG. 5 a is replaced with a forced cooling device 33. The cooling device 33 includes a tube 34, a distal end portion 29, and a proximal end portion 30. The tube 34 includes a coaxial inner tube 35 that forms an inner lumen 36 and an outer lumen 37. The inner tube 35 is perforated toward the distal end of the tube so that the inner lumen 36 and the outer lumen 37 are in communication with each other. In use, a self-contained pump 38 causes cooling fluid 39 to flow from the inner lumen 36 to the distal end 29 and back through the outer lumen 37 for continuous circulation. The circulating fluid is heated by the second electrode 3, and heat is sent to the proximal end 30 of the tube 34 by the fluid. In this way, the second electrode 3 is maintained at a low temperature despite the high temperature in the first electrode 2.

残りの図は、組織７の凝固あるいは乾燥を行なうための、第三電極４０を備えた装置を示めしている。図６ａにおいて、メス１は図４ｂの構造にもとずいて示めされていて、類似の部品は同一符号が付番されている。第三電極４０は、第一電極２と対向して第二電極３に取りつけられていて、さらに電気絶縁体４１に取りつけられている。ＲＦ信号はジェネレータ１０からリード線４２を介して第三電極４０へ供給することができる。絶縁体４１は、シリコンラバーの薄い層か、又はポリマイド、ＰＥＥＫ若しくはＰＶＣ材料を含む別の材料の薄い層で作られている。薄い層により、熱がシリコンラバー層を通過することを保証され、かつ凝固用電極４０が第二電極３の熱伝導の恩恵を受けることができることを保証されている。このようにして、第一電極２により発生された熱にもかかわらず、凝固用電極４０は比較的低温に維持されている。使用にあたって、組織は前述したように切開される。切開の代りに凝固が所望される場合、第三電極４０は組織７と接触して置かれ、凝固用ＲＦ信号が第二電極３と第三電極４０との間に作用される。   The remaining figures show a device with a third electrode 40 for coagulating or drying the tissue 7. In FIG. 6a, the knife 1 is shown based on the structure of FIG. 4b, and similar parts are labeled with the same reference numerals. The third electrode 40 is attached to the second electrode 3 so as to face the first electrode 2, and is further attached to the electrical insulator 41. The RF signal can be supplied from the generator 10 to the third electrode 40 via the lead wire 42. The insulator 41 is made of a thin layer of silicon rubber or another layer of material including polymide, PEEK or PVC material. The thin layer ensures that heat passes through the silicon rubber layer and that the coagulation electrode 40 can benefit from the heat conduction of the second electrode 3. In this way, despite the heat generated by the first electrode 2, the coagulation electrode 40 is maintained at a relatively low temperature. In use, the tissue is incised as described above. If coagulation is desired instead of incision, the third electrode 40 is placed in contact with the tissue 7 and a coagulation RF signal is applied between the second electrode 3 and the third electrode 40.

図６ｂは別の実施形態を示めしていて、第二電極３及び第三電極４０が窒化アルミニウム材料の基板４３の上に金属化されたトラックとなっている。前述したように、この材料は電気的に絶縁されているけれど、良伝導体であって、熱が第二電極から第三電極へ熱を伝導することを可能にしている。   FIG. 6b shows another embodiment in which the second electrode 3 and the third electrode 40 are tracks metallized on a substrate 43 of aluminum nitride material. As described above, although this material is electrically isolated, it is a good conductor and allows heat to conduct from the second electrode to the third electrode.

図７は、第一電極２が第二電極３と第三電極との間に設置されている装置を示めしている。第二及び第三電極３及び４０の両者は、ほぼ半円形断面であって、ほぼ円柱体を形成していて、第一電極２が両者の中央領域から僅かに突出している。絶縁層４は第一電極２と第二電極３とを隔てていて、絶縁層４１が第一電極２と第三電極４０とを隔てている。使用者が器具で組織を切開する場合、ジェネレータ１０は切開用ＲＦ信号を第一電極２と、第二及び第三電極３，４０の一方又は両方との間に作用する。一方、使用者が組織を凝固する場合、ジェネレータ１０は凝固用ＲＦ信号を第二電極３と第三電極４０との間に作用する。第二及び第三電極３０及び４０の比較的広い表面積は、前述したように切開時において熱が伝導で逃げてゆくのと同じく、組織の効果的な凝固を可能にしている。   FIG. 7 shows an apparatus in which the first electrode 2 is installed between the second electrode 3 and the third electrode. Both the second and third electrodes 3 and 40 have a substantially semicircular cross-section and form a substantially cylindrical body, and the first electrode 2 slightly protrudes from the central region of both. The insulating layer 4 separates the first electrode 2 and the second electrode 3, and the insulating layer 41 separates the first electrode 2 and the third electrode 40. When the user cuts tissue with the instrument, the generator 10 applies a cutting RF signal between the first electrode 2 and one or both of the second and third electrodes 3,40. On the other hand, when the user coagulates the tissue, the generator 10 applies a coagulation RF signal between the second electrode 3 and the third electrode 40. The relatively large surface area of the second and third electrodes 30 and 40 allows for effective coagulation of the tissue, similar to the way heat escapes during conduction as previously described.

図８は別の構造を示めしていて、第二及び第三電極３及び４０が並行して備えられている。第一電極２はほぼ平面であって、絶縁層４が、第一電極を器具の反対側における第二及び第三電極３及び４０から隔てている。電極３及び４０は、並行配列で配置されていて、間に絶縁層４１がある。前述したように、器具は、第一電極２と、第二又は第三電極３又は４０との間におけるＲＦ信号を用いて組織を切開することができ、あるいは第二電極と第三電極との間におけるＲＦ信号を用いて組織を凝固することができる。   FIG. 8 shows another structure in which the second and third electrodes 3 and 40 are provided in parallel. The first electrode 2 is substantially planar and an insulating layer 4 separates the first electrode from the second and third electrodes 3 and 40 on the opposite side of the instrument. The electrodes 3 and 40 are arranged in a parallel arrangement with an insulating layer 41 in between. As described above, the instrument can incise tissue using an RF signal between the first electrode 2 and the second or third electrode 3 or 40, or the second electrode and the third electrode The RF signal in between can be used to coagulate tissue.

図９は別の実施形態を示めしていて、第一、第二及び第三電極が“サンドイッチ”配列に直列層として備えられている。第一電極２が図９における最上段層として、第三電極４０が最下段層としてかつ第二電極３がそれらの間にはさまれて図示されている。絶縁層４及び４１は、それぞれ第一、第二及び第三電極を隔てるようになっている。この配列がブレード１に対して比較的厚いエッジを提供していて、組織の凝固を容易なものとしている。   FIG. 9 shows another embodiment, where the first, second and third electrodes are provided as a series layer in a “sandwich” arrangement. The first electrode 2 is shown as the uppermost layer in FIG. 9, the third electrode 40 is shown as the lowermost layer, and the second electrode 3 is sandwiched between them. Insulating layers 4 and 41 separate the first, second and third electrodes, respectively. This arrangement provides a relatively thick edge for the blade 1 to facilitate tissue coagulation.

図１０は、サンドイッチ配列構造体と並行配列構造体との両者の特徴を利用している装置である。電極はサンドイッチ配列であって、図１０において第一電極２は、図９に図示されているような最上段というよりはむしろ最下段に図示されている。第二電極３はサンドイッチの中段にあって、絶縁層４により第一電極から隔てられている。図１０において、第三電極４０は、最上段電極として図示されているけれど、中央凹部を有しており、その凹部を介して第二電極３の隆起部分５０が突出している。第二及び第三電極は絶縁体４１により隔てられていて、突起５０の最上面は第三電極４の頂部と同一高さとなっている。図１０に示めすようにこの配列は、メス１あるいは最上面のどちらかを組織の凝固に使用することができるようになっている。   FIG. 10 shows an apparatus that utilizes the characteristics of both the sandwich array structure and the parallel array structure. The electrodes have a sandwich arrangement, and in FIG. 10, the first electrode 2 is shown at the bottom rather than the top as shown in FIG. The second electrode 3 is in the middle stage of the sandwich and is separated from the first electrode by an insulating layer 4. In FIG. 10, the third electrode 40 is illustrated as the uppermost electrode, but has a central recess, and the raised portion 50 of the second electrode 3 protrudes through the recess. The second and third electrodes are separated by an insulator 41, and the uppermost surface of the protrusion 50 is flush with the top of the third electrode 4. As shown in FIG. 10, this arrangement allows either the scalpel 1 or the top surface to be used for tissue coagulation.

図１１は、メス１の端部が、両側面に絶縁層４及び４１を備えた中央第一電極２を有している。絶縁層４及び４１各々が、図５１及び５２それぞれに図示する傾斜したベベル末端部を有している。第二電極３は絶縁層４に取りつけられ、第二電極におけるベベル端部５１は、メスの軸において第一電極２から軸方向にセットバックしている。同様に第三電極４０が絶縁層４１に取りつけられていて、第三電極におけるベベル端部５２も第一電極２から軸方向にセットバックしている。ベベル端部５１及び５２は、第一電極と第二電極との間、及び第一電極と第三電極との間において０．２５mmの最小間かく（図１１において“Ｘ”で図示）を可能にしていて、メス１を全体としてスリムなプロフィールとしている。第一電極２は、第一及び第二絶縁層４及び４１の端部から図１１に図示するように僅かに突出していてもよい。前述したように、第一電極による熱伝達は、不連続的に絶縁層に取りつける、あるいは熱伝達を低減するために複数の穴をあける等の、種々の方法で低減されている。 In FIG. 11, the end portion of the knife 1 has a central first electrode 2 having insulating layers 4 and 41 on both side surfaces. Insulating layers 4 and 41 each have a beveled end beveled as illustrated in FIGS. 51 and 52, respectively. The second electrode 3 is attached to the insulating layer 4, and the bevel end 51 of the second electrode is set back in the axial direction from the first electrode 2 on the axis of the female. Similarly, the third electrode 40 is attached to the insulating layer 41, and the bevel end portion 52 of the third electrode is also set back from the first electrode 2 in the axial direction. The bevel ends 51 and 52 allow for a minimum gap of 0.25 mm (shown as “X” in FIG. 11) between the first electrode and the second electrode and between the first electrode and the third electrode. The female 1 has a slim profile as a whole. The first electrode 2 may slightly protrude from the ends of the first and second insulating layers 4 and 41 as shown in FIG. As described above, the heat transfer by the first electrode is reduced by various methods such as discontinuously attaching to the insulating layer or making a plurality of holes to reduce the heat transfer.

本発明は、第一電極と第二電極との間の間隔、そこに作用される電圧、電極及び電気絶縁体として選択されたサイズと材料を含んでいる、多くのデザインパラメータの周到な選択によるものである。この周到な選択により、電極間における直接的なアークが発生しないこと、一つの電極だけが活性電極となること、そして帰還電極は低温維持されることとが保証されている。なおその低温維持は、帰還電極に到達する熱を防止することにより及び／又は熱をそこから除去し熱を第二電極へ伝達することにより行なわれている。   The present invention is based on careful selection of a number of design parameters, including the spacing between the first electrode and the second electrode, the voltage applied thereto, the size and material selected as the electrode and electrical insulator. Is. This careful selection ensures that no direct arcing occurs between the electrodes, that only one electrode becomes the active electrode, and that the return electrode is maintained at a low temperature. The low temperature is maintained by preventing heat reaching the return electrode and / or by removing heat from it and transferring the heat to the second electrode.

相対的に低温の帰還電極は、器具の帰還電極に隣接している組織において熱損傷が比較的小さいかあるいはなくて、一方組織が帰還電極から熱を伝導で除去することに役立っている。   The relatively cold return electrode has relatively little or no thermal damage in the tissue adjacent to the instrument return electrode, while the tissue helps remove heat from the return electrode by conduction.

図１は、本発明における電気式外科手術装置の概略ダイアグラムである。FIG. 1 is a schematic diagram of an electrosurgical apparatus according to the present invention. 図２は、本発明における電気式外科手術用メスの概略断面図である。FIG. 2 is a schematic cross-sectional view of an electric surgical scalpel according to the present invention. 図３は、図２における電気式外科手術用メスを用いての横断切除操作を示めす概略図である。FIG. 3 is a schematic view showing a transverse excision operation using the electric surgical scalpel in FIG. 2. 図４ａは、本発明による別の実施態様における電気式外科手術用メス（その−１）の概略断面図である。FIG. 4a is a schematic cross-sectional view of an electrosurgical scalpel (part-1) according to another embodiment of the present invention. 図４ｂは、本発明による別の実施態様における電気式外科手術用メス（その−２）の概略断面図である。FIG. 4b is a schematic cross-sectional view of an electrosurgical scalpel (part-2) according to another embodiment of the present invention. 図４ｃは、本発明による別の実施態様における電気式外科手術用メス（その−３）の概略断面図である。FIG. 4c is a schematic cross-sectional view of an electrosurgical scalpel (part-3) according to another embodiment of the present invention. 図４ｄは、本発明による別の実施態様における電気式外科手術用メス（その−４）の概略断面図である。FIG. 4d is a schematic cross-sectional view of an electrosurgical scalpel (part-4) according to another embodiment of the present invention. 図５ａは、本発明における冷却手段を組込んだ電気式外科手術用メス（その−１）の概略図である。FIG. 5a is a schematic view of an electrosurgical knife (part-1) incorporating a cooling means according to the present invention. 図５ｂは、本発明における冷却手段を組込んだ電気式外科手術用メス（その−２）の概略図である。FIG. 5b is a schematic view of an electrosurgical knife (part-2) incorporating the cooling means according to the present invention. 図６ａは、本発明における補助的な凝固用電極を組込んだ別の電気式外科手術用メス（その−１）である。FIG. 6a is another electrosurgical scalpel (part-1) incorporating the auxiliary coagulation electrode according to the present invention. 図６ｂは、本発明における補助的な凝固用電極を組込んだ別の電気式外科手術用メス（その−２）である。FIG. 6b is another electrosurgical scalpel (part-2) incorporating the auxiliary coagulation electrode of the present invention. 図７は、本発明における補助的な凝固用電極を組込んだ別の電気式外科手術用メス（その−３）である。FIG. 7 is another electrosurgical scalpel (part-3) incorporating the auxiliary coagulation electrode according to the present invention. 図８は、本発明における補助的な凝固用電極を組込んだ別の電気式外科手術用メス（その−４）である。FIG. 8 is another electrosurgical knife (part-4) incorporating the auxiliary coagulation electrode according to the present invention. 図９は、本発明における補助的な凝固用電極を組込んだ別の電気式外科手術用メス（その−５）である。FIG. 9 is another electrosurgical knife (-5) incorporating the auxiliary coagulation electrode according to the present invention. 図１０は、本発明における補助的な凝固用電極を組込んだ別の電気式外科手術用メス（その−６）である。FIG. 10 is another electrosurgical scalpel (-6) incorporating the auxiliary coagulation electrode according to the present invention. 図１１は、本発明における補助的な凝固用電極を組込んだ別の電気式外科手術用メス（その−７）である。FIG. 11 is another electrosurgical scalpel (part-7) incorporating the auxiliary coagulation electrode according to the present invention.

Claims (21)

第一電極及び第二電極と、該電極を離間している電気絶縁体とを具備する二極型切開用メスであって；
該第一電極が該第二電極と異なる特性を有しており、該第一電極が活性電極になり、そして該第二電極が帰還電極となっており；
該第一及び第二電極間の離間距離は０．２５mmと３．０mmとの間であって、該両電極が組織と接触して、該二極型切開用メスによる切開のために電圧が該第一電極と該第二電極との間に作用される場合、アークは該両電極間に直接的に発生しないようになっていて；組織を凝固するようになっている第三電極がさらに備えられていて、該第三電極はさらなる絶縁体により該第二電極から隔てられている二極切開用メスにおいて；
該第一、第二及び第三電極がサンドイッチ構造体の層となっていて、該第一電極が中央にあって、該電極各々の間に絶縁体の層があることと；
該第一電極が、該第二及び第三電極の外周縁から僅かに突出しており、そして該絶縁体の層各々の外周縁から僅かに突出していることとを特徴とする、二極型切開用メス。A bipolar incision knife comprising a first electrode and a second electrode, and an electrical insulator separating the electrodes;
It is wherein the first electrode have different characteristics and said second electrode, the said first electrode becomes active electrode, and the said second electrode has a return electrode;
The distance between the first and second electrodes is between 0.25 mm and 3.0 mm so that both electrodes are in contact with tissue and no voltage is applied for incision by the bipolar scalpel. when acting between said first electrode and said second electrode, the arc is not so not directly generated between the both electrodes; a third electrode adapted to coagulate tissue further In a bipolar scalpel provided, wherein the third electrode is separated from the second electrode by a further insulator;
The first, second and third electrodes are sandwiched layers, the first electrode is in the center, and there is an insulator layer between each of the electrodes;
Bipolar incision characterized in that the first electrode protrudes slightly from the outer periphery of the second and third electrodes and slightly protrudes from the outer periphery of each layer of the insulator For scalpel. 該第二及び第三電極が並行配列となっていて、両電極の間に該さらなる絶縁体を備えていることを特徴とする、請求項１に記載の二極型切開用メス。The bipolar incision scalpel according to claim 1, wherein the second and third electrodes are arranged in parallel, and the further insulator is provided between the electrodes. 該第二及び第三電極の一方が切欠き部分を備えていることを特徴とする、請求項１又は２に記載の二極型切開用メス。The bipolar scalpel for scissors according to claim 1 or 2, wherein one of the second and third electrodes has a notch. 該第二及び第三電極の他方が突起部分を備えていることを特徴とする、請求項３に記載の二極型切開用メス。The bipolar scalpel for scissors according to claim 3, wherein the other of the second and third electrodes has a protruding portion. 該一方の電極の該切欠き部分が、該電極の他方の該突起を収容していることを特徴とする、請求項４に記載の二極型切開用メス。The bipolar scalpel for scissors according to claim 4, wherein the notched portion of the one electrode accommodates the projection of the other of the electrode. 該突起部分が、該切欠き部分を囲んでいる該電極と同一高さになっていることを特徴とする、請求項５に記載の二極型切開用メス。6. The bipolar incision knife according to claim 5, wherein the protruding portion has the same height as the electrode surrounding the notch portion. 該第二電極の温度が７０℃を越えないことを保証するための手段をさらに具備している、請求項１−６のいずれか一項に記載の二極型切開用メス。The bipolar scalpel knife according to any one of claims 1 to 6, further comprising means for ensuring that the temperature of the second electrode does not exceed 70C. 該第二電極の温度が７０℃を越えないことを保証するための該手段は、該第一電極から該第二電極への熱伝達を最小にするための手段を備えていることを特徴とする、請求項７に記載の二極型切開用メス。The means for ensuring that the temperature of the second electrode does not exceed 70 ° C. comprises means for minimizing heat transfer from the first electrode to the second electrode. The bipolar scalpel for scissors according to claim 7. 該電気絶縁体が、４０Ｗ／ｍ.ｋ未満の比較的小さな熱伝導率を有して材料で作られていることを特徴とする、請求項８に記載の二極型切開用メス。9. A bipolar scalpel according to claim 8, wherein the electrical insulator is made of a material having a relatively low thermal conductivity of less than 40 W / m.k. 該第一電極が該電気絶縁体に不連続的に取りつけられていることを特徴とする、請求項７又は８に記載の二極型切開用メス。The bipolar scalpel knife according to claim 7 or 8, wherein the first electrode is discontinuously attached to the electrical insulator. 該第一電極が該電気絶縁体に一ヶ所以上の接触位置で取りつけられていることを特徴とする、請求項１０に記載の二極型切開用メス。The bipolar incision knife according to claim 10, wherein the first electrode is attached to the electrical insulator at one or more contact positions. 該第一電極は、該電気絶縁体と接触する割合を低減するように複数の穴があけられていることを特徴とする、請求項１０又は１１に記載の二極型切開用メス。The bipolar incision knife according to claim 10 or 11, wherein the first electrode has a plurality of holes so as to reduce a ratio of contact with the electrical insulator. 該第二電極の温度が７０℃を越えないことを保証するための手段は、該第二電極からの熱伝達による熱除去を最大化する手段を備えていることを特徴とする、請求項７に記載の二極型切開用メス。8. The means for ensuring that the temperature of the second electrode does not exceed 70 ° C. comprises means for maximizing heat removal by heat transfer from the second electrode. 2. A bipolar incision scalpel according to 1. 該第二電極が、１５０Ｗ／ｍ.ｋより大きな比較的高熱伝導率の材料で形成されていることを特徴とする、請求項１３に記載の二極型切開用メス。14. The bipolar scalpel for scissors according to claim 13, wherein the second electrode is formed of a material having a relatively high thermal conductivity greater than 150 W / m.k. 該第二電極が、該第二電極から熱を除去するために補助的な冷却手段を備えていることを特徴とする、請求項１３又は１４に記載の二極型切開用メス。15. The bipolar incision scalpel according to claim 13 or 14, wherein the second electrode is provided with auxiliary cooling means for removing heat from the second electrode. 該さらなる電気絶縁体を通過する熱伝達が５mW／mmHeat transfer through the further electrical insulator is 5 mW / mm 22 .ｋより大きくなるようになっていることを特徴とする、請求項１−１５のいずれか一項に記載の二極型切開用メス。The bipolar scalpel knife according to any one of claims 1 to 15, wherein the scalpel is larger than .k. 該第二電極と異なる該第一電極の特性には電極の断面積が含まれていて該第一電極の断面積は、該第二電極の断面積より相当小さなものであることを特徴とする、請求項１−１６のいずれか一項に記載の二極型切開用メス。The characteristics of the first electrode different from the second electrode include the cross-sectional area of the electrode, and the cross-sectional area of the first electrode is considerably smaller than the cross-sectional area of the second electrode. The bipolar incision knife according to any one of claims 1 to 16. 該第二電極と異なる該第一電極の特性には電極の熱伝導率が含まれていて、該第一電極の熱伝導率は、該第二電極の熱伝導率より相当小さなものであることを特徴とする、請求項１−１７のいずれか一項に記載の二極型切開用メス。The characteristics of the first electrode different from the second electrode include the thermal conductivity of the electrode, and the thermal conductivity of the first electrode is considerably smaller than the thermal conductivity of the second electrode. The bipolar scalpel for scissors according to any one of claims 1 to 17, characterized by: 該第二電極と異なる該第一電極の特性には電極の熱容量が含まれていて、該第一電極の熱容量は、第二電極の熱容量より相当小さなものであることを特徴とする、請求項１−１８のいずれか一項に記載の二極型切開用メス。The characteristics of the first electrode different from the second electrode include the heat capacity of the electrode, and the heat capacity of the first electrode is substantially smaller than the heat capacity of the second electrode. The bipolar incision knife according to any one of 1-18. 二極型切開用メスと、該二極型切開用メスが取りつけられているハンドピースと、該二極型切開用メスに無線周波数電圧を供給するための電気式外科手術用ジェネレータとを具備する電気式外科手術装置において；A bipolar incision scalpel, a handpiece to which the bipolar incision scalpel is attached, and an electrosurgical generator for supplying radio frequency voltage to the bipolar incision scalpel In an electrosurgical device;
該二極型切開用メスが、請求項１−１９のいずれか一項に記載の二極型切開用メスであり；The bipolar scalpel is the bipolar scalpel according to any one of claims 1-19;
該電気式外科手術用ジェネレータが、ほぼ一定のピーク電圧値を有する無線周波数電圧信号を該二極型切開用メスに供給するようになっている；電気式外科手術装置。The electrosurgical generator is adapted to supply a radio frequency voltage signal having a substantially constant peak voltage value to the bipolar scalpel; an electrosurgical device. 該ピーク電圧が２５０Ｖと６００Ｖとの間である、請求項２０に記載の電気式外科手術装置。21. The electrosurgical device of claim 20, wherein the peak voltage is between 250V and 600V.
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