JPH10512479A - ボールペン式流体利用電気焼灼装置 - Google Patents

ボールペン式流体利用電気焼灼装置

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JPH10512479A
JPH10512479A JP9517341A JP51734197A JPH10512479A JP H10512479 A JPH10512479 A JP H10512479A JP 9517341 A JP9517341 A JP 9517341A JP 51734197 A JP51734197 A JP 51734197A JP H10512479 A JPH10512479 A JP H10512479A
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ミューリアー,ピーター・エム・ジェイ
ホーイ,マイケル・エフ
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Abstract

(57)【要約】 電気焼灼装置が開示されている。この発明の一態様に従って、電気焼灼電極/先端部には遠位端部がボールペン式先端部で終わっている中空の導電性管が準備されている。流体、望ましくは導電性流体が、中空の電極/先端部の近位端部に印加されて、電気焼灼中それの遠位端部から放出される。ボールペン式遠位先端部は、この遠位先端部が組織に直接当てられて組織に沿って「ころがされ」又は滑らされることを可能にする。これは、遠位先端部が組織上でのひきずり又はひっかかりを伴うことなく、組織上で移動させられることを可能にする。加えて、遠位先端部から放出された導電性流体は更に、遠位先端部が組織上で移動するときに、この先端部を潤滑する。導電性流体が使用されたならば、電極/先端部から発出する導電性流体はRF電気焼灼エネルギーを遠位先端部から導き去り、その結果組織の焼灼を実際に行うのは遠位先端部ではなくて主としてその流体になる。すなわち、流体は「仮想」の電気焼灼電極として役立つ。焼灼、凝固及び剥離を行うのは遠位先端部ではなく流体であるので、組織に対して焼損又は穴あきは行われず、現場におけるくずの量が減少する。また、電極/先端部を通る流体の流れは遠位先端部を清浄に且つ冷たく保つのに役立つ。

Description

【発明の詳細な説明】 ボールペン式流体利用電気焼灼装置 発明の分野 この発明は、一般に医用機器の分野に、更に詳細には電気焼灼装置に関する。 体組織を切開し、焼灼するための種々の形式の電気焼灼装置が医療分野におい て周知であり且つ利用されている。典型的には、そのような装置は、患者に結合 された接地用電極を経由して完成される電気回路における一方の電極として役立 つ導電性先端部又は針を備えている。組織の切開は、電気エネルギーの源(最も 普通には、無線周波発生器)をこの先端部に印加することによって実施される。 先端部が組織に当てられると、電圧勾配が発生され、これによって電流の流れ及 び接触点における関連の熱発生が誘起される。十分に高いレベルの電気エネルギ ーを用いると、発生される熱は組織を切断し且つ好都合にも切断血管を同時に焼 灼するのに十分である。 従来の技術において広く認められていることであるが、組織の電気焼灼術によ り発生される大抵の場合、相当量の煙は少なくとも不愉快であり、またある場合 には手術者及び他の付添いの医療要員に対して気を散らさせ又は危険でさえある 。その結果として、煙吸引機能を備えた電気焼灼装置を準備して、電気焼灼によ り発生した煙を切開の区域から迅速に除去するようにすることが提案されており 、且つよく知られている。煙吸引は、電気焼灼装置において電気焼灼先端部/電 極の近くに、真空又は吸引源に結合されるべき入口ポートを準備することによっ て実施されることができる。これの例は「電気焼灼装置及び方法並びにそれを清 浄化するための手段(Electrocautery Apparatus a nd Method and Means for Cleaning the same)」という名称のウェーバー(Weber)に対する米国特許第43 07720号、「煙吸引式電気外科用装置(Smoke Aspirating Electrosurgical Device)」という名称のヒルシュフ ェルト(Hirschfeld)に対する米国特許第5242442号、並びに 「吸引利用式電気焼灼ユニット(Suction Assisted Elec trocautery Unit)」という名称のヒューエル(Hewell) に対する米国特許第5269781号に記述されている。 やはり従来の技術において認められていることであるが、凝固した血液、組織 くず、及びその他のくずの電気焼灼装置の電極/先端部における蓄積は、手術者 にとって問題を提起し、例えば滅菌してガーゼなどに先端部をこすりつけること によるなどして先端部を周期的に清浄化することを必要とすることがある。これ は一般に望ましくないと考えられているが、その理由は、電極/先端部の清浄化 の必要性が切開手順を中断する結果につながり且つ先端部の汚染又は切開と関連 した危険性、先端部の損傷、手術者のけがなどを増大するからである。この問題 を扱うために、従来の技術においては、電極/先端部が機器のハンドルと滑動可 能に係合している電気焼灼機器を準備して、先端部が手の中へ引っ込められたと きに、どのような付着しているくずもハンドルの先端部へ自動的にこすり落とさ れるようにすることが提案されている。そのような機器は上に引用されたウェー バー(Weber,Jr.)の米国特許第4307720号において提案されて いる。この配置は若干の利益を有するかもしれないが、先端部が引っ込められた ならばハンドルの先端部をぬぐい取ることがやはり必要であろう。この問題に対 するより直接的且つ有効な対策は、電気焼灼過程中に発生するくずの量を低減し て、これにより電極/先端部を清浄化する必要性を除去する又は少なくとも低減 することであると考えられる。 心房細動は、心臓の正常な周期的収縮が筋肉心臓壁の速い不規則な痙攣によっ て置き換えられた状態である。米国においては少なくとも100万人が心房細動 を病んでいる。心房細動中に発生する少なくとも三つの有害な副作用、すなわち 、速い不規則な心搏、AV同期性の喪失に起因する心臓血行動態の障害、及び血 栓塞栓症に対する罹病率の増大がある。医学博士ハースト,J.ウィリス他著「 心臓不整脈の外科的治療法」867ページ(Surgical Treatme nt of Cardiac Arrythmia , by Hurst, J.Willis, M.D. et all, pg.867)。 心房細動 に対する一般的な治療法は患者に薬剤を与えることである。心房細動のある大抵 の患 者に対しては、この療法は適度に有効であるにすぎず、且つ一般的には望ましく ない副作用を発生する。 心房細動を治療するための薬物療法についての諸問題を考慮して、心房細動を 永久に治すような外科的治療法を見いだすことが望ましいと認められてきている 。「心臓血管装置最新情報」1995年7月号、1ページ(Cardiovas cular Device Update , July 1995, pg.1 )。無線周波カテーテル剥離法(RFCA)は、ウォルク−パーキンソン−ホワ イト及びAV結節再入頻搏のような上心室頻搏(SVT)の最も良性の原因を治 療する安全且つ有効な方法であることがわかっているけれども、心房細動を治療 するために剥離法を用いることはむずかしいことが判明している。同上文献。 いわゆる「迷路」処置法が心房細動を治療するために開発されている。「迷路 」処置法においては、切開が開胸外科手順により右及び左の心房へと行われる。 これらの切開は、心房に発生して心房細動を生じさせるようなすべての電位再入 回路パターンを遮断するように配置される。「迷路」処置法についての臨床的結 果は良好であった。 「迷路」処置法についての問題は望ましくない開胸手術を必要とすることであ る。剥離法により「迷路」処置をコピーすることが望ましいであろうことは認め られている。同上文献3ページ。これは「迷路」のような処置を胸腔鏡法により 行うことの可能性を与えるであろう。しかしながら、現在の剥離技術は「迷路」 処置法が剥離法によりコピーされることを可能にするようには発展していないこ ともまた認められている。同上文献。 従来技術の剥離法についての問題は、剥離用先端部が、あまりにも長い間組織 片と接触したままにされたならば、組織を焼き焦がしてこれに穴をあけることで ある。多くの使用において、組織が剥離されるのを可能にするために十分な時間 の間組織片上の正しい位置に剥離用先端部を置くことと、焼き焦がしてこれによ り組織に穴をあけるような長さの時間の間それを正しい場所に置かないこととを 比較考量することは困難であることが判明している。 従来技術の剥離装置についての別の問題は、剥離用先端部が長い間組織と接触 したままにされるならば、先端部が剥離されている組織に「くっつく」ことであ る。先端部を取り去る際、組織の大部分がしばしば先端部に付着して取り去られ る。これは組織損傷の故に回避されるべき結果であるだけでなく、医師にとって 時間を消費し且ついらいらさせるものである。これらは明らかに回避されるべき 問題である。発明の要約 前述の諸問題を考慮して、この発明は改良形電気焼灼機器に向けられている。 この発明の一態様に従って、電気焼灼電極/先端部は中空の導電性管で実現さ れていて、これの遠位端部にはボールペン式の先端部がある。電気焼灼中に導電 性流体が中空電極/先端部の近位端部に印加されて、その遠位端部から放出され る。ボールペン式遠位先端部は、この遠位先端部が組織に直接当てられて組織に 沿って「ころがる」又は滑ることを可能にする。これは遠位先端部が、組織上で のひきずり又はからまりを伴うことなく、組織上で移動されることを可能にする 。加えて、遠位先端部から放出された導電性流体は更に、これが組織上を移動す るにつれて遠位先端部を潤滑する。 この発明の別の態様に従って、電極/先端部から発出する導電性流体は、遠位 先端部からRF電気焼灼エネルギーを導き、従って組織の焼灼を実際に行うのは 遠位先端部ではなくて主として流体である。すなわち、流体は「仮想」電気焼灼 電極として役立つ。焼灼、凝固及び剥離を行うのは遠位先端部ではなくて流体で あるから、組織に対して焼き焦がし又は穴あけが行われず、剥離の場所における くずの量は低減される。また、電極/先端部を通る流体の流れは遠位先端部の清 浄に且つ保冷に役立つ。図面の簡単な説明 この発明の前述及びその他の態様は、この発明の特定の実施例についての詳細 な説明に関して、添付の諸図面に関連して読まれたときに最もよく認識されるで あろう。この諸図面中、 図1は、この発明の一実施例による電気焼灼装置の透視図である。 図2は、ハンドルから分離されたこの発明の透視図である。 図3は、図1の電気焼灼装置の遠位端部の拡大透視図であって電極/先端部を 示している。 図4は、図1、2及び3の装置の電極/先端部の断面図である。 図5は、この発明の電極/先端部の別の実施例の断面図である。発明の特定の実施例の詳細な説明 図1に言及すると、この発明の一実施例による流体利用の電気焼灼装置10の 透視図が示されている。電気焼灼装置10は、ハンドル12及び電気焼灼電極/ 先端部14を含んでいる。ハンドル12は望ましくは、ナイロンなどのような滅 菌可能な剛性のある非導電性の材料で作られている。電極/先端部14はハンド ル12に取り付けられている。 この発明の一態様に従って、電極/先端部14は、望ましくは中空の円筒形の 管16を用いて実現され、これの遠位端部には、図3及び4のそれぞれ著しく拡 大された透視図及び断面図に示されたように、「ボールポイント」がある。図示 のように、ボール18は、これの周りで金属製の管16の端を曲げることによっ て形成された空洞に保持されている。ボール18及び管16は両方共望ましくは ステンレス鋼のような導電性金属で作られている。管16は、それぞれボール1 8に対する近位及び遠位、20及び22において曲げられている。 ボール18は任意の直径を有することができるが、約1ないし約5mmの直径 を有するボール18は剥離のために特に有効であることが判明している。管16 は、ここで説明されたようなボール18の直径に対応する直径を持たなければな らない。従って、管16は特にその遠位端部において約1ないし約5mmの内径 を有することが望ましい。 曲げは管16の内部26の方へ向けられた管16の周囲の周りの一連の「ひだ 」24を配置することを含むが、これには限定されない多くの技法によって実施 されることができる。更に、管16の遠位端部28は、これを管16の内部26 の方へ丸めることによって「クリンプ」されることができる。この方法で、ボー ル18は「ひだ(クリンプ)」24と丸められた遠位端部28との間に保持され る。曲げ(クリンピング)は、ボール18の一部分が遠位端部28を越えて遠位 方向へ延びるように行われるべきである。 管16は、望ましくは内部26においてボール18の直径よりもわずかに大き い直径を有している。いずれにせよ、上述のようなクリンピングの後では、ボー ル18を取り囲む管16の部分はボール18よりもわずかに大きい内径を有する べきである。このことは、ボール18がクリンプ24と遠位端部28との間で自 由に回転し、しかもなお電極/先端部14に保持されることを可能にする。 電気絶縁物30は、望ましくは管16をほぼその全長に沿って取り囲んでいて 、遠位端部28から短い距離で終わっている。絶縁物30は、万一管16が処置 中不注意に患者組織に接触した場合に、偶発的焼灼が電極/先端部14以外の場 所で行われるのを防止する。 二つの接続部が電気焼灼装置10に対して作られている。無線周波(RF)発 生器(図1には示されていない)の一方の端子(例えば、正)が、管16に取り 付けられた電線32を介して電極/先端部14に電気的に結合されている。ボー ル18と管16との間の接触は、以下においてより詳細に記述されるように、ボ ール18に電位を与える。 電極/先端部14から放出されるべき流体の源がたわみ入力管路34を介して 管16に結合される。入力管路34は望ましくは管又はホースである。導電性流 体は、圧力下で管16を通して電極/先端部14に供給される。導電性流体は、 図2に示されるように、管16の流体入口ポート36に接続されている入力管路 34を通じて管16に導入される。導電性流体は入力管路34から流体入口ポー ト36を通じて管16へ進み、そして管16の長さに沿って電極/先端部14に 伝えられ、これの遠位端部から放出される。これは電気焼灼を行うための、いわ ゆる「仮想電極」を生成する。 RFエネルギーの印加と同時に導電性流体を注入することは、Peter M .J.Mulier及びMichael F.Hoeyの名義で1993年8月 27日に出願された「RF剥離のための方法及び装置(Method and Apparatus for R−F Ablation)」という名称の米国 特許出願連続番号08/113441、Peter M.J.Mulierの名 義で1994年9月8日に出願された「RF剥離のための方法及び装置(Met hod and Apparatus for RF Ablation)」と いう名称の米国特許出願連続番号08/303246、Peter M.J.M ulier及びMichael F.Hoeyの名義で1994年9月8日に出 願 された「RF剥離のための方法及び装置(Method and Appara tus for RF Ablation)」という名称の米国特許出願連続番 号08/302304、並びにPeter M.J.Mulier及びMich ael F.Hoeyの名義で1995年2月22日に出願された「流体利用電 気焼灼装置(Fluid Assisted Electrocautery Device)」という名称の米国特許出願連続番号08/393082、に更 に詳細に論述されている。前記の’441、’246、’304及び’082出 願(以下においては集合的に「RF剥離特許出願」と呼ばれる)は、それぞれこ の発明の譲受人に共有譲渡されており、それぞれそっくりそのままこの明細書に 参照文献として組み込まれる。 RF剥離特許出願において記述されたように、RFエネルギーの印加区域への 導電性流体の注入は「仮想電極」を生成するが、これの大きさ及び形状は制御可 能に変更されることができ、且つこの電極は幾分導電性にされることができ、こ れによってRFエネルギーの広がりを変更する。RFエネルギー及び持続時間、 導電性液体の注入率、並びに注入溶液の導電率のような諸要因を変えることによ って、「仮想電極」の大きさ、形状並びに強度、すなわち、その区域における熱 生成の強度、を制御することができる。この発明による電気焼灼装置の場合には 、RFエネルギーの印加中の導電性溶液の印加は、電極/先端部の過熱の防止、 それのない場合に組織の焼損又は黒焦げが普通発生するような点の拡大の防止に 役立つ。この効果を高めるために、注入される溶液は最初に冷却されてもよいと 考えられる。 仮想電極を確立するために適当であると考えられる導電性溶液は特に、塩水、 飽和塩水、及びリンガー溶液を含んでいる。導電性流体の源に関しては、通常の ポンプを入力管路34に結合すればよいと考えられる。代替的に、ポンプを必要 としないように小形事前与圧式の、導電性溶液入りの缶を使用してもよいと考え られる。一実施例においては、ハンドル12は、これにそのような与圧式缶を受 けて、入力管路34の必要性を除去するように構成することもできる。 加えて、電気焼灼装置10を用いての処置中に流体をより可視的にするために 導電性流体に染料を混合してもよい。そのような染料の例はメチレンブルーを含 むが、これには限定されない。 制御された圧力の下で電極/先端部14に導電性流体を供給することが望まし い。特に、導電性流体が電極/先端部14の遠位端部28から過度に流出するこ とを許容する流量率を有しないことが重要である。過度の流体の流れは、組織の 大きい区域に電流密度を広げ、これにより剥離効果を最小限にし、またある場合 には阻止することが証明されている。 使用の際、前述のように無線周波(RF)発生器から管16に電位が印加され る。管16は導電性金属でできているので、管16全体は無線周波(RF)発生 器により決定された電位になる。導電性流体が圧力下で電気焼灼装置10に供給 され、その結果、導電性流体は電極/先端部14からボール16の周りに放出さ れる。 電気焼灼装置10の使用者は、電極/先端部14を焼灼するべき区域に配置し 、組織と接触しているボール18によって電極/先端部14を組織上で移動させ る。ボール18は組織上でころがるか又は滑らされることができる。遠位端部1 8から放出された流体は組織を潤滑し、ボール18が組織上でころがるか又は滑 るかに関係なく組織上でのボール18の移動を容易にする。 生体外実験の結果、次のことが明らかになった。すなわち、ボール18の直径 が大きいほど、組織上に形成される剥離「軌跡」は広くて深く、電極/先端部1 4を組織上でゆっくり移動させると電極/先端部14を迅速に移動させた場合よ りも深い損傷が生じ、且つ電気焼灼装置10を通って電極/先端部14から流出 する導電性流体の流量率は、組織の表面をぬらし且つ潤滑するのに十分であるべ きであるが、組織上で広がって剥離を行うための必要な電流密度を広げるほど高 くされるべきではない。電気焼灼装置10を通る導電性流体の望ましい流量率の 例として、50ワットの無線周波(RF)発生器では、約0.5ないし2cc/ 分の流量率が適当であることが証明され、また25ワットの無線周波(RF)発 生器では、約1ないし2cc/分の流量率が適当であることが証明された。これ らの電力範囲における他の流量率又は他の電力設定値に対するこれら若しくは別 の流量率もまた、この発明を用いた実施により明らかになるように使用されるこ とができる。前述の例は例示の目的のために与えられており、限定的であるよう に意図されてはいない。 電気焼灼装置10は特に、前述のいわゆる「迷路」処置法に関連して使用され て、心臓のある区域を剥離し、心房において発生して心房細動を生じさせること のできるようなすべての電位再入回路パターンを遮断することができる。電気焼 灼装置10はまた、ほんの二三の可能な用途を挙げれば、痔若しくは拡張蛇行静 脈を除くために、又は食道出血を止めるために、都合よく利用されることができ るであろう。この装置は他の形式の焼灼について普通に認められる穴あきの危険 性を除去し、「描く」のが容易であり、且つ深くて広い針入及びその後の剥離を 可能にする。 ボールペンとの類似性のために、この発明は「描く」のが容易である電気焼灼 装置10を提供する。すなわち、ボール18が組織上でころがるので、剥離され るべき組織上で遠位の電極/先端部14を移動させるのが容易である。加えて、 電極/先端部14から流体を放出することによって、ボール18はまた剥離され ている組織上で滑動する。 図1の実施例においては、電線32及び入力管路34が別々に画かれているけ れども、これらの電気焼灼装置10への接続部は、絶縁電線と並んで導電性溶液 の入力のための流体伝導内腔を有する単一の管路へと統合され得るものと考えら れる。 電極/先端部14の種々の代替的形態もまた考えられる。図5に示された一実 施例においては、ボール18は管16の遠位端部28において管16内に閉じ込 められている。しかしながら、ボール18に最も近いクリンプ(ひだ)24を有 する代わりに、管16内でボール18に隣接してブロック38が配置されている 。ブロック38は、望ましくはその近位端部からその遠位端部に出て行く中央内 腔40を有していて、管16の内部の流体がボール18へ送られるのを可能にし 、流体はここで遠位端部28から放出されることができる。他のすべての点にお いては、この実施例は前述の好適な実施例と同じである。 ボール18はまた、多孔性の導電材料で作られることができる。この実施例に おいては、ボール18の多孔性は、流体がボール18の周りに送られて遠位端部 28から放出されるだけでなく、ボールを通して送られて放出されることを可能 にする。 代替的実施例においては、ボール18は、導電性の細長いプラグのような非球 面接触素子で置き換えることができる。この実施例においては、プラグは、流体 がプラグの周りに送られて遠位端部28から放出されることができるように、管 16の遠位端部28において管16内にやはり保持されることになるであろう。 プラグは、クリンプ(ひだ)24及び丸められた遠位端部28を含むが、これら には限定されない前述の任意の手段によって保持されることになるであろう。し かしながら、プラグは球状ではないので、剥離されるべき組織上で接触して移動 させられるときにころがることができない。その代わりに、プラグは組織上で滑 ることになる。この実施例においては、プラグはまた導電性多孔質材料で作られ ることができる。 この発明は、導電性流体を用いて電極/先端部14の代わりに仮想電極を生成 することに関連して記述されてきたけれども、電極/先端部14の滑らかな流れ のようなこの発明の利点の多くは導電性流体を純水のような非導電性流体で置き 換えることによっても招来されることは明らかである。それゆえに、非導電性流 体の使用を含めることもまたこの発明の範囲内にある。 加えて、所望ならば、煙又は余分の流体が手術の現場から除去されることを可 能にするために、電気焼灼装置10に吸引管を加えてもよい。そのような吸引管 は前述の米国特許出願連続番号08/393082において記述されており、こ れの教示事項はこの明細書に参照文献として組み込まれている。 更に、管16は、ボール18と接触することになるその遠位端部の部分を除い て、電気絶縁材料で作られてもよい。ボール18と接触することになる管16の この部分は導電性であるべきである。この実施例においては、電線24は管16 のこの導電性部分まで延びている。 この発明の特定の実施例についての前述の詳細な説明から、体組織の流体利用 電気焼灼を行うための方法及び装置が開示されていて、これにおいては中空の電 気焼灼電極/先端部から供給された流体が組織の切開及び焼灼を行う仮想電極を 形成することは明らかなはずである。 この発明の特定の実施例がここでは記述されてきたけれども、これは単にこの 発明の種々の態様を例示する目的のために行われており、この発明の範囲に関し て制限を行うように意図されてはいない。ここで特に論述されたものを含むがこ れに限定はされない種々の置換例、改変例、及び/又は変更例が、次に続く添付 の諸請求項に記載されたようなこの発明の精神及び範囲から外れることなく開示 実施例に対して行われ得ることは考えられる。
───────────────────────────────────────────────────── 【要約の続き】 場におけるくずの量が減少する。また、電極/先端部を 通る流体の流れは遠位先端部を清浄に且つ冷たく保つの に役立つ。

Claims (1)

  1. 【特許請求の範囲】 1. 近位端部及び遠位端部を有する管を含んでいて、この管の遠位端部の少 なくとも一部分が導電性であり、この管が少なくともその遠位端部に隣接したこ の管の部分に内腔を有しており、この内腔が圧力下で流体の源に接続可能であり 、且つ、管の遠位端部において管内に閉じ込められた導電性のボールを含んでい て、このボールが管の遠位端部を越えて遠位方向へ延びている、流体利用の電気 焼灼装置。 2. (a)無線周波数の源から、この源に接続された導電性の管の端部に閉 じ込められた導電性のボールを介して電気焼灼場所に無線周波エネルギーを印加 する段階、及び (b)段階(a)と同時に、前記の電極から放出された導電性液体を前記の電 気焼灼場所に注入する段階、 を含んで入る電気焼灼を行う方法。
JP51734197A 1995-11-02 1996-10-02 流体補助形の電気焼灼装置 Expired - Lifetime JP3425957B2 (ja)

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AU697542B2 (en) 1998-10-08
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CA2376365C (en) 2008-12-02
US20020010463A1 (en) 2002-01-24
US6585732B2 (en) 2003-07-01
US7166105B2 (en) 2007-01-23
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US20030181902A1 (en) 2003-09-25
CA2376365A1 (en) 1997-05-09
CA2234676C (en) 2002-04-09
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US6764487B2 (en) 2004-07-20
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US20060074414A1 (en) 2006-04-06
US6949098B2 (en) 2005-09-27
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US7422588B2 (en) 2008-09-09
US6358248B1 (en) 2002-03-19
US20040236324A1 (en) 2004-11-25
US7364579B2 (en) 2008-04-29
DE69626300T2 (de) 2003-10-16
WO1997016127A1 (en) 1997-05-09
ATE232699T1 (de) 2003-03-15
US7794460B2 (en) 2010-09-14
US20070208332A1 (en) 2007-09-06
US5897553A (en) 1999-04-27
EP1245196A1 (en) 2002-10-02
US20070118114A1 (en) 2007-05-24
AU7514096A (en) 1997-05-22

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