JP3566722B2 - 子宮内膜を剥離するための装置 - Google Patents
子宮内膜を剥離するための装置 Download PDFInfo
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Description
本願は1992年5月1日出願第07/877,567号の一部継続出願である。
技術分野
本発明は身体器官の内部ライニングをその場で破壊するための方法および装置に関し、さらに詳しくは子宮出血を治療するための子宮摘出手術にかわる子宮内膜の選択的な破壊方法を提供するものである。
背景技術
身体器官の内部ライニングを除去したり破壊したりする従来の手法は、病気や病的症状を治療するための外科的摘出にかわる方法を提供するために追究されてきたものである。従来の手法としては化学薬品類によるものや、無線周波(RF)、極超短波による加熱、寒冷療法、レーザー外科治療および電気外科治療など種々の形態の熱エネルギーを利用して内部ライニングを破壊的に治療するものがある。無線周波と極超短波エネルギーの場合はその場で熱を発生させるためにライニングに直接適用することもあった。
熱的な破壊の一方式としては米国特許第4,979,949号に、胆嚢の粘膜層をRFバルーン電極による抵抗熱で熱的に除去する方法が開示されている。電流はバルーンからバルーンに充填された導電性の膨張液を通って流される。この装置は導電性流体中で電力損失を発生するため単一電極型以外のものには適用できないし、また個々の電力のコントロールおよび/または温度センサ−のコントロールが完全にできない。
また別の先行技術による治療法の例としては、米国特許第5,045,056号に記載されているように、加熱した液体とともに用いるバルーンカテーテルが身体器官の空腔の熱的剥離用として供されている。さらに、膨張させたバルーンの中に入れた単一電極を用いて極超短波や高周波のRFエネルギーを体の局部に適用して体組織を破壊する方法が米国特許第4,662,383号および米国特許第4,676,258号に記載されている。
上述のような先行技術に開示されている方法の欠点は、完全な剥離を行うために必要とされる均一な温度コントロールないしは温度検知能力が欠如しているために、広い領域の均一な施術ができないことである。
その他今日までに開発されている方法としては、ライニングの連続領域に小さな治療用道具を手技で適用するものがあるが、これは値の張る手術室技法であり、その他従前の熱バルーン治療法と同様に、均一な手術結果を得られる保証が少ないものである。
発明の開示
したがって本発明の目的の一つは、ライニングの剥離中に視覚的な確認を必要とせずに、安全かつ迅速な子宮内膜剥離を実施できる新規な方法および装置を提供することにある。
本発明の別の目的は、手術室の使用を必要とすることなく、外来診療ベースで子宮内膜の剥離を行うことができる装置および方法を提供することにある。
本発明の上記の2つの目的は子宮内膜表面に適合する拡張可能な部材を利用する方法によって達成される。その拡張部材を非導電性の媒体で充満し、RF電流を子宮内膜の実質的に全表面にわたって流す。電流は一回の施術において、抵抗熱によって子宮内膜の温度を45℃から90℃の範囲内に、子宮筋層の平均温度を42℃またはそれ以下に保ちながらライニングの細胞を破壊するのに充分な時間加熱できるようなものとする。このRF電流は少なくとも250kHz以上、かつ100MHz以下の周波数を有するものとする。
本発明による方法は、導電性で拡張部材を拡張していない状態で子宮頸部口から子宮腔に挿入し、次いでこれを子宮内膜の表面と接触するように拡張し、RF電流を拡張した状態の部材に流すというものである。
本発明のさらに別の目的は、片側表面に一連の個別の電極を有し、さらにそれぞれの電極に温度センサ−からのフィードバック温度を伝えるためにそれぞれの電極に通ずる温度センサ−を備えた薄い袋(bladder)を含んだ導電性の拡張部材を提供することにもある。子宮内膜温度を希望のレベルにするために、複数の個別の電極はそれぞれサーミスタのフィードバック温度によって個別に順次印加される。
本発明のさらに別の目的は、電極全体に複数の貫通孔を設けるか、または電極を線状パターンに形成することによって均一な端部密度を作り出し、電極表面全体の電流密度を平準化させることによって熱が電極の端部に集中せず、したがって電極表面全体にわたって均一な加熱ができるような特定の構成になる電極を提供することにある。
本発明のさらに別の目的は、従来の過電圧発生型電源の出力をコントロールし、電源から順次電気を制御しながらバルーンの電極に供給することができる電子制御手段を提供することにもある。
本発明のさらに別の目的は、子宮に剥離用装置を挿入し、剥離完了後に取り出すことができるように、使い捨て型の手持ち式アプリケータと電極を組み込んだ装置を提供することにある。
本発明のさらに別の目的は、拡張部材の上に一連の個別電極とそれに通ずる個別のサーミスタを一連の電力リード線とともに備えた装置を提供することにあり、それぞれの電力リード線は子宮内膜剥離の温度制御をするためにフィードバック温度を個々の電極およびそれに通ずるサーミスタに電力を供給するものである。
本発明のさらに別の目的は、本装置を所定の位置に置く場合の視覚的な補助手段とするための光学繊維映像通路を包含することができる内部ルーメン(管路)を提供することにある。
【図面の簡単な説明】
本発明のより完全な理解と、この発明に付随する多くの利点については以下の詳細な説明を付帯図面と照合して読み進めることによって容易に得られるであろう。ここで、
図1は拡張部材としての導電性バルーンを拡張した形で子宮に入れた状態の断面図であり;
図2は図1の装置の拡張していない状態の図であり;
図3は子宮内膜の小区画と拡張した部材の関係を示す拡大断面図であり;
図4a−bは複数の表面区画を有し、かつ各区画に個別の電導性表面と温度センサーを備えた拡張部材の実施態様の図であり;
図5は図4に示した多区画要素のための電力制御システムの配線略図であり;
図6は有孔電極と拡張部材の外側表面に図示のような電力導線を備えた多区画要素の実施態様を示したものであり;
図7は拡張部材の内側に備えたサーミスタ導線と円形状ワイヤ接続取付けパッドを示したものであり;
図8aおよび8bは図6および7の拡張部材の内側および外側部分それぞれに電極/サーミスタ導線を備えた両面型のものを示したものであり;
図9は金属処理した平坦な基材を蛇紋様に配列して拡張部材に接着剤により結合した実施態様を示したものであり;
図10a−bは拡張部材を子宮に入れるための袋器具を示し;
図11a−cは図10の袋器具を引き出した状態ならびにしぼませた状態の拡張部材を示す図であり;
図12は袋器具の電力発生装置および試験装置への接続を模型的に示したものであり;
図13は図5の温度測定回路の実施態様の配線略図であり;そして
図14は図13と同様のもので、効果的な組織分流を示したものである。
発明を実施するための最良の形態
図面中の参照番号はいくつかの図において同一または相当する部品を示すが、具体的に図1の本発明の装置の断面図においては拡張部材として導電性バルーンを使用しており、図2では図1と同じ装置のバルーン要素を膨らませる前の状態が示されている。子宮2は子宮腔を取り囲む子宮筋層組織4からなっている。正常な子宮腔または子宮包はほぼ逆三角形状の平担な腔で、上部の2つの隅が卵管6を通して卵巣につながり、下部の開口部は勁管8につながっている。子宮包の全表面には卵管6および勁管8への入口が含まれ、これらは子宮内膜として知られる薄い組織層で覆われている。この子宮内膜細胞を選択的に破壊するのが本発明で開示している改良された方法および装置の目標である。
図1のように開発された単電極システムを治療すべき子宮内膜表面に沿うように膨張させると、これによって表面の襞を減らすように子宮内膜が拡張および伸展される。この拡張された子宮内膜表面に無線周波数の電流を、子宮内膜の温度を45℃から90℃に上昇させて子宮内膜細胞を破壊するのに充分な時間、好ましくは10秒以内、通電する。この温度は子宮内膜組織が破壊される迄、最適には55℃から65℃の間で10分間迄、維持する。
電流は拡張部材の中または表面に沿って流され、拡張部材の内部は流体またはガスのような非電導性物質で満たされる。拡張部材は、圧縮されるかさもなければ子宮頸部口から挿入可能な小径の形状にでき、挿入後に拡張の効果をもたらすために膨張もしくは拡大され得るものであればどのような材料、物品でもよい。この拡張部材は子宮内膜と直接電気的な結合をするか、あるいは容量性結合をもたらす。電気回路を完成させるために、他端の電気接続は患者の皮膚の広い領域に接するような接地板か接地パッチとする。
組織内を流れる電流によって抵抗熱が発生する。電力密度は電極からの距離の4乗に反比例して低減する。よって発生した熱は子宮内膜とこれを直接取り囲む筋肉組織、本発明の場合はライニングに接する子宮筋層部分、に集中する。子宮筋層4は非常に血管に富むため、熱はここから急速に逃げる。その結果、子宮内膜12の温度は子宮筋層4および子宮の残りの部分より早く破壊温度まで加熱することができる。この温度の関係から、子宮内膜の剥離は局部麻酔を利用する簡単な医学的手順によって安全に遂行することができる。その上本法は、本発明以前のシステムにくらべてはるかに経済的に、かつ危険の少ない子宮内膜剥離法として利用可能である。
膨張可能バルーンまたは膨張可能袋は図2に示されているように子宮腔15に挿入され、次いでガスまたは非電導性流体によってバルーンを膨張させて、図1に示すように膨張した表面が子宮腔に沿うようにして子宮腔を伸展させて充満する。バルーン14の各部は卵管6への入口へと伸展するとともに、子宮内膜表面12の全体に沿って子宮頸部8まで延びる。バルーンはチューブ16に取付けられ、流体を漏らさないシールを形成する。チューブ16は小径の流体供給チューブ18とともに導線のためのリード線とセンサーのための付加的なリード線からなる電力ケーブル20を含んでいる。複数の温度センサ−24がバルーンの内表面に接触しているところが図示されている。あるいは、このリード線の形状は各センサーごとにリード対22で置き換えられたものでもよい。温度センサ−24は従来のサーミスタまたは熱電対であり、過熱に対して最も鋭敏な子宮内膜表面の領域に接触するバルーン領域上に配置される。この温度センサ−は光学繊維からなる温度センサ−であってもよい。流体供給チューブ18は、後で図13との関連で説明する従来の流体制御システムを通して、ガスまたは流体源に接続される。
図3は子宮内膜の一小区画と、図1の拡張バルーン要素の関係を示す拡大断面図である。子宮筋層4の上に支えられている子宮内膜のライニング12は、膨張したバルーン要素14によって伸展された後であっても通常不規則な表面となっている。バルーン14の外表面の導電性表面35と子宮内膜12の間の電気的な接触は、バルーンの外表面を生理的に無毒で非刺激性の従来の導電性溶液、ペーストあるいはゲル37で覆うことによって改善することができる。好適な導電性媒体としては細動除去器などの表面被覆に用いられる公知のゲルやペーストを挙げることができる。好適な導電性ゲルの例としては、生理食塩水などの水性の電解溶液から得られるカルボキシメチルセルロースゲルが挙げられる。導電性の溶液、ペーストないしゲルは、バルーン表面の小孔や子宮内膜表面の凹凸を埋めることによってバルーンと子宮内膜間の電気的接触を向上させる。
拡張バルーンや袋は天然ゴムや合成ゴムなどのエラストマー性ポリマーにカーボンや導電性金属粒子などの導電性粒子を混ぜることによって導電性としたものとすることができる。あるいは、バルーンや袋の壁の外表面や内表面を導電性のゲルなどの導電性材料で被覆したり、導電性金属で被覆することで導電性とすることができる。導電性被覆は従来行われている蒸着、電着、スパッタリングなどによって有機ポリマーの表面に行うことができる。
好ましいバルーンは薄く非伸展性のポリマーフィルム、たとえばポリエステルや他の可撓性のある熱可塑性または熱硬化性ポリマーフィルムの外表面あるいは内表面の上に導電性の金属被覆を施したものである。フィルムは非伸展性の袋を形成するが、この袋は、袋が完全に膨らんだとき器官を拡張して、破壊されるべき子宮内膜のライニングとの接触をもたらす形状と大きさとする。非伸展性の袋の内表面は、もしその袋の壁厚が約0.25mm未満であるならば子宮内膜に容量性結合をする導電性材料で被覆されていてもよい。
拡張部材の表面はオープンセルの多孔性材料、たとえばフォーム(泡材料)やこれに類似の小部屋が連なった多孔性材料であって、対向する子宮内膜表面との良好な電気的接触を確保するのに必要な量の導電性溶液、ペーストないしはゲルを保持できるものとすることができる。その表面は導電性物質で被覆してもよいし、導電性物質を含浸させたものでもよい。
図4は複数の表面区画を有するバルーンを拡張可能な袋部材39として用いた実施態様を示す。各表面区画には個別の電導性表面と温度センサ−を備えている。この実施態様において、各区画へコントロールされた電力を供給するために、バルーンの内表面か外表面のいずれかに導電性金属の区画された電極被覆を施す。各導電性区画40は従来型のリード線で電気的に電源(図示せず)に接続される。各導電性区画40はまたサーミスタ42も有し、従来型リード線でスイッチマトリックスへ接続される。図4bは袋電極39の上面図を示すもので、特に袋電極の中心を通って延びる管路44を表している。この管路は電極の中心を通して挿入される光の案内ガイドとなる。言い換えれば、平面フィルムの中心部に内部ルーメンチューブ44が取付けられている。
図5は上述の、たとえば図4に関連して述べた、多区画バルーンのための電源制御装置およびスイッチマトリックスの電気配線略図である。図5に示すように、電気リード線は図4の袋の電気サーミスタ対にコネクタ138を通して接続される。サーミスタのリード線はマトリックス配電盤(スイッチバンク)134に接続され、電極リード線はスイッチバンク136に接続される。各サーミスタ(図4a)42はコンバータ116で変換される前に温度測定回路128および分離用増幅器126によってサンプリングされ、コンピュータ114に送られる。温度測定回路は測定された温度とサーミスタの基準電圧132を比較する。電極スイッチ136はコンピュータ114の出力に応じて光学アイソレータ132によってコントロールされる。RF入力部からの入力は過電圧・過電流プロテクタ110を通って流れ、サプレッションユニット124で過電圧を抑制される前にバンドパスフィルター112でフィルターがかけられる。この電圧はトランス138、140および142によって分離され、トランス142および144からのトランス電圧ViおよびVvはRMS−DC変換器118によって変換器116に流れるRMS電圧に変換される。変換の前に、信号ViおよびVvもまた高速アナログマルチプライヤー120に流され、コンピュータ114からのRF制御はインターフェース112を通して供給される。
図4の電極構造の一変形が図6に示されているが、そこでは有孔電極150がそれらの電力導線152とともに示されている。図6の電極袋では有孔電極150は袋の外側に取付けられている。
図7は袋の内側のサーミスタ共通導線154と、円形状ワイヤ接続パッド156とサーミスタの基盤となる取付け部157を示している。この共通導線は電極およびそれに通ずるサーミスタの両方に電力を供給する。図7は袋の両内面を示したものである。
図8a−bはサーミスタ導線がついた両面電極の外側および内側を示すもので、外側には有孔電極160を備え、内側にはサーミスタワイヤパッド162および電極電力リード線164ならびにサーミスタ取付け部分166を有している。袋の内側と外側の接続は図8aおよび8bに連続した形で示されている。図8bは袋の断面を具体的に示した図で、上側ないし外側表面に電極160を備え、電力導線164およびサーミスタワイヤパッドと取付け部分166を下側ないし内側に備えている。図8bはサーミスタ163を取付け部分166の上に取付けたものを示しており、電力導線とサーミスタはサーミスタリード線169で接続されている。図8bは有孔電極160の1つの孔以外はすべて基材または袋174に到達する深さを有することを明瞭に示している。ここで取り上げた1つの孔だけは有孔電極160と下側ないし内表面の電力導線164の間を電気的に接続するように袋を貫通している。図8aの実施態様は図7の電力導線および結合表面の内面図と、図6の有孔電極を組み合わせたものに相当するが、図6の実施態様では有孔電極のための電力導線が外側表面についているのに対し、図8aのものは電力導線が内側表面についている点が異なる。
図6、7および8それぞれにおいて内側または外側面と称しているのは、必然的に四面を有することになる袋の2つの面だけを指している点に注意しなければならない。膨らませる前の袋は2つの外側三角形表面(上側および下側)と、膨らませる前の2つの内側三角形表面で表される。
電極構造のさらに別の変形が図9に示されているが、ここでは金属処理された平坦な基材が電極170および172として、袋の上および下両方の外側表面に接着剤により接合されているのが示されている。金属処理されて接着剤により接合された電極は、適用する領域の均一な加熱を促進するために蛇紋様の電極パターンを形成するようにする。
図10AおよびBは本発明の上述のいずれかの実施態様に基づいて作られた袋電極を挿入するために使用する袋アプリケーション器具を示す。図10Bはこのアプリケーション器具の側面図で、さや型アプリケータに主チューブとワイヤリード線を覆う収縮包装がついたものを示している。光学繊維束がアプリケータの中心部に置かれ、これはたとえば図3で示した管路を通して接続される。アプリケータ器具175には拡張用流体注入口176および電極ワイヤ挿入口176ならびに管路(ルーメン)を通す光学観察用繊維入口178を有する。袋の電極180の動きはアライメントガイドと、親指用くぼみ182とともに動くさや引き戻しノブ181によってコントロールされる。図10Aのアプリケータは伸ばした状態、ただし膨らませていない状態を示している。
図11a−cは図10の袋器具の引き戻した状態を示すもので、図11bおよび11cはそれぞれA−A'およびB−B'の位置でとらえた断面である。図11cは主チューブを引き戻した位置でB−B'線におけるしぼませた袋の状態を示したものである。アプリケータ175のその他の特徴は図10に示したものと同じである。
図6−9のいずれかの実施態様のアプリケーション器具175と電極バルーン190の接続の模型を図12に示す。拡張用ポンプ193はバルーン190の拡張用媒体を供給し、一方電極ベルト195は制御システム100に接続する基準電極となる。RF発生器197は図5に配線を示した制御システムへのRF入力を過電流接続ケーブル199を通して供給する。コントロールモジュール203および接続制御装置204はコンピュータ114に接続されている。
図12および図5の電極システムおよびコントロールシステムが接続されると、子宮内膜温度を望ましい温度に高めるためにRF電極はサーミスタの温度フィードバックによって個別に、単独かつ順次に印加される。このシステムはこれを従来型の過電流電力供給装置197からの出力を受けて自動的に行う。前述のように、電極は種々の構成のものがあるが、均一な加熱をするための種々の電極構成によって、加熱は電極表面上の子宮内膜部に集中する。電極表面全体に熱を集中させる一例としては、図6および8に示したような電極に孔をあけた実施態様とするものがある。均一な加熱は電極を図9の蛇紋様パターン構造のような線状に延ばすことによっても得ることができる。
こうした種類の組み立てによって、本発明の施術方法ならびに電極エレメントは、”電極端からの距離”の関数として電流密度を加熱用に増大させることができる。さらに前述のように、電極を袋の外側に、また電力用導線、サーミスタ、およびサーミスタリード線を袋の反対側表面に配置することができる。
図6−9の実施態様において、種々の電極パターンはいずれも電極とそれに通ずるサーミスタ用の電力導線を共用するものとなっている。これはつまり、1本の電力リード線によって個々の電極ならびにそれに通ずるサーミスタに電力を供給することによって袋電極の組み立てにおいて必要なサーミスタ用リード線を半数に節約することになる。これらの実施態様においてはそれぞれの電極は対応するサーミスタのリード線をRF電力のリード線と共用するようにしている。すべてのサーミスタからの2番目のリード線は、たとえば図7および8aに示されているように1本の共通線にまとめて接続される。この配線ではN個の電極とN個のサーミスタを備えた剥離用バルーンを作動させるのに必要なリード線はN+1本だけという利点がある。しかしこうした組み立ての場合、図5の温度測定回路128には個々のサーミスタと個別の電極それぞれに個別の電力リード線を備えた構成のものに要求される条件にさらに別の要求が加わる。電極用とサーミスタ用を個別のリード線とする組み立てはよく知られており、種々の個別電極の温度測定法の中からいずれかの方法を使用することができる。
共通の電力リード線を各電極および各サーミスタに使用することによる特別な要求事項は図13に示されている実施態様によって解決することができる。図13ではRF電力はスイッチマトリックス210を通すことによってそれぞれ選択された電極に供給される。電極/サーミスタ回路は図の右側に220で一般化して示されており、具体的な例として抵抗器222、224および226で表されている3つの電極および3つのサーミスタが示されている。基準電圧Vrefは操作用増幅追従器232によって緩衝され、測定用スイッチマトリックス240に入る前に抵抗器233に入る。抵抗器233の出力は操作用増幅器234によって緩衝される。測定用スイッチマトリックス240の出力はフィルター244、246および248を通される。これらのフィルターは高い周波数のRFをブロックし、DCおよび非常に低い周波数の電圧を通過させるローパスフィルターである。
バルーンサーミスタの共通リード線227はフィルター249を通って地面に流される。
施術中は、RF電力スイッチマトリックス210の操作によって希望する特定の1つの電極または複数の電極にRF電力が供給される。サーミスタの抵抗222、224または226の測定値はRF電力に接続される特定の電極ごとに独立したものとなる。RT1(222)の測定値を得るために、測定用スイッチマトリックスは抵抗器233の右側のリード線1に接続され、一方その他のすべてのリード線は追従器234の出力につながるように設定される。この特定の設定と組み立てによって電圧VTはVref・RT1/(Rb+RT1)に等しくなる。したがって既知のRbおよびVrefによってRT1の値が決まる。回路220の他のリード線2、3は追従器234によって同じ電圧に保たれるのでこれらのリード線間の電圧差はなく、したがってそれらには電流は流れない。
このようにリード線の間に電流が流れないことは非常に重要なことである。なぜならば図13の回路がなければ、電極に接触している組織が効果的な分流通路となり、さもなければ測定電圧VTに影響を及ぼすことになるからである。
この組織による効果的な分流は図14に同様の回路として、電極261、262および263の間をつなぐ効果的な組織抵抗253および254で示されている。
袋電極は、電極の厚さを増やすために両面型の薄膜平坦フィルムを片面に付し、厚い方の面に電極パターンのための堆積マスクをリソグラフ技法により付す。しかる後、反対面の温度検知エレメントにつながる導線のためのマスクを付す。そしてマスクのついていない導線を浸食によって取り去り、希望するパターンを残す。
サーミスタ(図4a)42は表面マウント技法により取付けられ、付属する内側管路は平面フィルムの中央部に取付けられる。そして図10に示されているように、袋は折り畳まれ、主チューブの互いに摺動する内側および外側の同心チューブの隣接端にシールして取付けられる。次に導線を主チューブの外側に出し、このアプリケータの把手の近くの器具の終端部にもってゆく。外側チューブは導線の外側に置かれ、図10bに示すように熱収縮加工される。最後に図10または図11のアプリケータの把手が取付けられる。
電極バルーンを作る方式としては予めブロー成型した物や、カプトン(Kapton)導電性エレメントの上に銅を付けた物を適合性のあるバルーン表面上に形成するなど他の形式のものを使用することもできる。さらにこのバルーンは、内側のラテックスバルーンの外側にぴったり合うような形状の適合性のある“ソックス”のように形成することもできる。その他電極バルーン構造として、バルーンから把手部まですべてを板状またはエッチングしたワイヤを使用したものなども考えられる。本発明を利用すると、この器具の把手の中のメモリーチップに検量線を記憶させることによって低精度のサーミスタを使用することもできる。袋への電極の結合は導電性の接着剤またはハンダ付けによって行うことができる。
図10および11のアプリケータはバルーンの前端部を内側に引き戻し、バルーンをその周りに折り畳むことによって取り外すことができる。取り外しを容易にするためには、パターン電極をアプリケータの中に折り畳みやすくできるように、鞘におさまる特殊な種類の背骨を使用してパターンを作ることもできる。
当然のことながら、上記の開示に照らせば本発明について多くの修正や変型が可能である。したがって明細書中に具体的に説明したもの以外に、付帯の請求の範囲において本発明を実施することができることを理解いただきたい。
Claims (20)
- 身体器官の子宮内膜ライニングを選択的に破壊する子宮内膜剥離装置であって、
破壊すべき子宮内膜ライニングとの電気的接触を起こさせるような導電性の拡張可能な電極手段と、
前記拡張可能な電極に接続され、前記子宮内膜ライニングを45℃から90℃の範囲の均一な温度に加熱するために前記電極手段に周波数250kHz以上の電流を選択的に供給する無線周波電力手段とを包含し、
前記拡張可能な電極手段は、前記器官と前記の電気的接触を起こさせるために当該電極手段に非導電性の拡張用媒体を含んで伸展できるものであり、前記拡張可能な電 極手段は複数の個別の電極を備える、子宮内膜剥離装置。 - 前記周波数が250kHzから100MHzの範囲である、請求項1に記載の子宮内膜剥離装置。
- 前記拡張可能な電極手段が導電性バルーンと、該導電性バルーンに接続された拡張用流体注入口とを含み、前記バルーンが前記非導電性拡張用媒体で満たされたものである、請求項1に記載の子宮内膜剥離装置。
- 前記バルーンが導電性エラストマーである、請求項3に記載の子宮内膜剥離装置。
- 前記拡張可能な電極手段が導電性材料で被覆された非伸展性の袋である、請求項1に記載の子宮内膜剥離装置。
- 前記非伸展性の袋の内面が導電性材料で被覆され、かつ袋の壁厚が0.25mm未満である、請求項5に記載の子宮内膜剥離装置。
- 前記拡張可能な電極手段が非伸展性の袋である、請求項1に記載の子宮内膜剥離装置。
- 前記電極のそれぞれがサーミスタを備えた、請求項7に記載の装置。
- 前記拡張可能な電極手段が少なくとも1つの温度検知手段を備えた、請求項1に記載の装置。
- 前記無線周波電力手段が出力を有し、前 記子宮内膜剥離装置が更に前記拡張可能な電極手段への前記無線周波電力手段の出力をコントロールするための制御手段をさらに包む、請求項1に記載の装置。
- 前記拡張可能な電極手段が拡張可能部材 及び金属処理された平坦な電極を含み、該金属処理され た平坦な電極が、前記拡張可能部材の外側に取り付けら れ、金属処理された平坦な電極が、型模様の電極を形成 するために蛇紋様に配列された、請求項1に記載の装置。
- 前記無線周波電力手段が出力を有し、前 記子宮内膜剥離装置が前記拡張可能な電極手段への前記 無線周波電力手段の出力をコントロールするために、前記サーミスタ個々の出力に応答する制御手段をさらに含 む、請求項8に記載の装置。
- 前記コントロール手段が前記拡張可能な電極手段の温度を測定するための、出力を有する少なくとも1つのサーミスタを含み、かつそのコントロール手段が前記の少なくとも1つのサーミスタの出力を基準値と比較する手段を含んだものであり、かつそのコントロール手段が前記無線周波電力手段の出力をコントロールするために前記手段に応答する出力を比較のために提供する、請求項10に記載の装置。
- 前記子宮内膜ライニングを10分間またはそれ以下の時間45℃から90℃の範囲の均一な温度に加熱するために、前記無線周波数電力手段が前記電極手段に電流を供給する、請求項1に記載の装置。
- 身体器官の子宮内膜ライニングを選択的に破壊する子宮内膜剥離装置であって、当該装置は、
中に含まれた拡張可能で伸展可能で複数の個別の電極を 有する電極構造物を手動でコントロールするための手持ち式のアプリケータを包含し、当該アプリケータは非導電性の拡張用媒体を受け入れるための注入口を有し、当該拡張可能な電極構造物が伸展された状態の時に前記拡張用媒体を前記拡張可能な電極構造物に送り出し、また当該アプリケータはさらに電力を前記拡張可能な電極構 造物に送るための電源入力部を有することを包含する、子宮内膜剥離装置。 - 子宮内膜剥離用の組み立て品であって、
手動により子宮へ挿入するための伸展可能で拡張可能で 複数の個別の電極を備える電極構造物を含んだ手持ち式アプリケータを備え、
前記アプリケータが、拡張用流体注入口と、前記拡張可能な電極構造物と電気的接触をもたらすための電力入力部とを有する、子宮内膜剥離用の組み立て品。 - 子宮内膜ライニングを破壊する目的のために子宮の内膜ライニングと電気的接触をもたらすための導電性の拡張可能な電極組み立て品であって、
内側表面と外側表面を有する拡張可能な内袋を有し、当該内側または外側表面のいずれか一面に複数の個別電極を有し、前記内側および外側表面の他方の面に前記複数の電極に対応する複数のサーミスタを備え、
前記複数の電極それぞれが複数の孔を有し、各電極の当該複数の孔の1つが前記外側表面から前記内袋を介して前記内側表面に貫通しており、当該貫通孔が前記電極と前記もう1つの表面との電気的導通をもたらすものであって、
前記もう1つの表面はさらに前記電極の対応する一つに 電気的に接続する複数の電力リード線を備えており、当該リード線はそれぞれ前記内袋の一端から前記貫通孔個々に延びており、前記電力リード線はまたそれぞれ前記サーミスタの各々にそれぞれに延びており、
これによって前記電極それぞれの複数の孔と前記電力リード線の関係によってそれぞれの電極個々の表面上に均一な加熱をもたらすものである、導電性の拡張可能な電極組み立て品。 - 前記拡張可能な電極手段が複数の個別電極とその複数の電極それぞれにつながるサーミスタを備え、さらに複数の電極の電力リード線を含み、当該リード線のそれぞれが前記複数の個別電極および前記サーミスタのそれぞれに電気的に接続されている、請求項1に記載の装置。
- 前記サーミスタそれぞれがさらに前記の別の表面上の共通接地リード線に接続されている、請求項17に記載の装置。
- 前記RF電力を少なくとも前記複数の電力リード線に選択的に供給するための第1スイッチマトリックス、第1基準電圧、第2基準電圧、および複数の電 力リード線の選択された一つを前記の第1基準電圧に接続し、同時に前記電極の残りすべてを前記第2基準電圧に接続する第2のスイッチマトリックスを含む温度測定回路を包含する、請求項18に記載の装置。
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US08/046,683 US5443470A (en) | 1992-05-01 | 1993-04-14 | Method and apparatus for endometrial ablation |
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1993
- 1993-04-14 US US08/046,683 patent/US5443470A/en not_active Expired - Lifetime
-
1994
- 1994-04-11 CA CA002159483A patent/CA2159483C/en not_active Expired - Fee Related
- 1994-04-11 EP EP94914032A patent/EP0693955B1/en not_active Expired - Lifetime
- 1994-04-11 JP JP52326494A patent/JP3566722B2/ja not_active Expired - Fee Related
- 1994-04-11 DE DE69431950T patent/DE69431950T2/de not_active Expired - Lifetime
- 1994-04-11 WO PCT/US1994/003695 patent/WO1994023794A1/en active IP Right Grant
- 1994-04-11 AU AU66255/94A patent/AU6625594A/en not_active Abandoned
- 1994-04-11 AT AT94914032T patent/ATE230284T1/de not_active IP Right Cessation
- 1994-04-11 ES ES94914032T patent/ES2189801T3/es not_active Expired - Lifetime
- 1994-04-12 IL IL10929694A patent/IL109296A0/xx unknown
- 1994-06-25 TW TW083105793A patent/TW295539B/zh active
-
1995
- 1995-06-07 US US08/481,940 patent/US6041260A/en not_active Expired - Lifetime
- 1995-06-07 US US08/484,089 patent/US5713942A/en not_active Expired - Lifetime
Also Published As
Publication number | Publication date |
---|---|
WO1994023794A1 (en) | 1994-10-27 |
ES2189801T3 (es) | 2003-07-16 |
CA2159483C (en) | 2000-02-22 |
TW295539B (ja) | 1997-01-11 |
DE69431950T2 (de) | 2003-11-13 |
ATE230284T1 (de) | 2003-01-15 |
EP0693955A4 (en) | 1998-01-07 |
CA2159483A1 (en) | 1994-10-27 |
EP0693955B1 (en) | 2003-01-02 |
US6041260A (en) | 2000-03-21 |
US5443470A (en) | 1995-08-22 |
DE69431950D1 (de) | 2003-02-06 |
EP0693955A1 (en) | 1996-01-31 |
AU6625594A (en) | 1994-11-08 |
US5713942A (en) | 1998-02-03 |
IL109296A0 (en) | 1994-07-31 |
JPH08508912A (ja) | 1996-09-24 |
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