JP3530528B2 - 絶縁された温度感知素子を有する切除電極 - Google Patents

絶縁された温度感知素子を有する切除電極

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Publication number
JP3530528B2
JP3530528B2 JP50874193A JP50874193A JP3530528B2 JP 3530528 B2 JP3530528 B2 JP 3530528B2 JP 50874193 A JP50874193 A JP 50874193A JP 50874193 A JP50874193 A JP 50874193A JP 3530528 B2 JP3530528 B2 JP 3530528B2
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Japan
Prior art keywords
temperature sensing
energy
tissue
temperature
well
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JP50874193A
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JPH08503381A (ja
Inventor
ディー． エドワーズ，スチュワート
エイ． スターン，ロジャー
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Boston Scientific Limited
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Boston Scientific Limited
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    • A61B18/12—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body by heating by passing a current through the tissue to be heated, e.g. high-frequency current
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Description

【発明の詳細な説明】 産業上の利用分野 本発明は、一般的にはカテーテル及び関連する電力源
に関する。さらに特定的には、本発明は、身体の内部領
域で操縦及び操作された後、治療を目的とする損傷を形
成するようにエネルギーを伝達する切除カテーテルに関
する。
発明の背景 今日の医療処置において、医師は、目的とする組織範
囲を切除するように身体の内部領域へアクセスするため
に、カテーテルを用いている。医師にとっては、組織を
切除するために用いられる体内でのエネルギー放射を慎
重且つ正確に制御することが重要である。
カテーテルに対する慎重且つ正確な制御の必要性は、
心臓内の組織を切除する処置の間は特に重大である。電
気生理学的治療と呼ばれるこれらの処置は、心臓のリズ
ム障害を治療するためにさらに広く用いられてきてい
る。
これらの処置の間、医師はカテーテルを大静脈又は大
動脈（典型的には、大腿動脈）を通して、治療されるべ
き心臓の内部領域へ進める。次に、医師は操縦機構をさ
らに操作して、カテーテルの末端に取り付けられた電極
が、切除されるべき組織に直接接するようにする。医師
は、組織を削除して損傷を形成するように、ラジオ波エ
ネルギーを電極の先端から組織を通して不関電極へ放射
する。
心臓の切除は、切除電極からのエネルギーの放射を正
確にモニタして制御するような性能を特に、必要とす
る。
発明の要旨 本発明は、切除電極、および該切除電極に付随し、改
良された組織温度感知能力を有するシステムを提供す
る。改良された組織温度感知能力によって、組織温度に
基づくシステム制御機能が強化される。
切除電極はエネルギー放出体を有する。温度感知素子
は、放出体の上に設置されている。該素子は、電極によ
って切除される組織の温度を感知する。
本発明によれば、電極は、放出体と温度感知素子の間
に設置された熱絶縁素子を有する。該熱絶縁素子によっ
て、温度感知素子と放出体との間の熱エネルギーの移動
が遮断される。
一実施例では、電極体上に複数の温度感知素子が形成
されている。少なくとも１つ、好ましくは全ての温度感
知素子が熱的に絶縁されている。
上記の電極を組み込んだシステムは、電極上に熱的に
絶縁された温度感知素子を用いて組織温度を測定するモ
ニタを有する。
熱的に絶縁された温度感知素子は、電極の周囲のサー
マルマスの影響を受けることなく、実際の組織温度を測
定する。
図面の簡単な説明 図１は、本発明の特徴を実施する、組織を切除するた
めのシステムを示す斜視図、 図２は、このシステムのための発生器並びに付随する
モニタ及び制御回路を示す概略図、 図３は、このシステムのための電力モニタ及び制御回
路を示す概略図、 図４は、このシステムのための組織インピーダンスモ
ニタ及び制御回路を示す概略図、 図5A及び図5Bは、このシステムのための組織温度モニ
タ及び制御回路を示す概略図、 図6AからＣは、組織の温度を測定するためにこのシス
テムと共に用いられ得る電極であって、熱的に絶縁され
た温度感知素子を有する電極を示す図、 図7AからＣは、組織の温度を測定するためにこのシス
テムと共に用いられ得る電極であって、熱的に絶縁され
た温度感知素子を複数個有する電極を示す図、並びに、 図8AからＣは、組織の温度を測定するためにこのシス
テムと共に用いられ得る電極であって、心臓の弁部分に
おいて用いられるような空間的形状を有しており、熱的
に絶縁された温度感知素子を複数個有する電極を示す図
である。
好ましい実施例の説明 図１は、本発明の特徴を実施する、人体の組織に対し
て切除を行うためのシステム10を示している。システム
10は、ラジオ波エネルギーを送達するラジオ波発生器12
を備えている。システム10はまた、ラジオ波放射用先端
電極16を有する操縦可能なカテーテル14を備えている。
図示される実施例において、システム10は単極モード
で動作する。この構成において、システム10は、スキン
パッチ電極を備えている。この電極は不関第２電極18と
して機能する。使用に際して、不関電極18は、患者の背
中又はその他の外部皮膚領域へ付着する。
或いは、システム10は、双極モードにおいて動作する
こともできる。このモードにおいて、カテーテル14に両
方の電極が設けられている。
図示される実施例において、切除電極16及び不関電極
18はプラチナからなる。
システム10は、多くの異なる環境において用いられ得
る。本明細書では、心臓の切除治療を行うために用いら
れる場合のシステム10を説明する。
この目的で使用される場合、医師は、大静脈又は大動
脈（典型的には大腿動脈）を通してカテーテル14を治療
されるべき心臓の内部領域へ進める。次に、医師は、先
端電極16が切除対象の心臓内の組織に接するように配置
するためにカテーテル14をさらに操作する。ユーザは、
接触した組織上に損傷を形成するために、先端電極16内
へ発生器12からラジオ波エネルギーを送る。
図１に示される実施例において、カテーテル14は、ハ
ンドル20、ガイドチューブ22、及び先端24を備えてお
り、先端24には先端電極16（以下では切除電極とも呼ば
れる）が設けられている。ハンドル20はカテーテル先端
24のための操縦用機構26を内蔵している。ハンドル20の
後方から延びているケーブル28はプラグ（不図示）を有
している。プラグは、切除電極16へラジオ波エネルギー
を送るために、カテーテル14を発生器12に接続する。ラ
ジオ波は、損傷を形成するように組織に熱を加える。
左右の操縦用ワイヤ（不図示）が、操縦用機構26を先
端24の左右側に相互接続するように、ガイドチューブ22
を通って延びている。操縦用機構26を左に回転させると
左操縦用ワイヤが引っ張られ、先端24が左へ曲げられ
る。同様に、操縦用機構26を右へ回転させると右操縦用
ワイヤが引っ張られ、先端24が右へ曲げられる。このよ
うに、医師は、切除されるべき組織に接するように切除
電極16を操縦する。
発生器12は、主分離型変圧器32を通して第１及び第２
の伝導線34及び36に接続されているラジオ波電力供給源
30を備えている。
図示される環境において、電力供給源30は、500kHzの
周波数で50ワットまでの電力を送達する。第１の伝導線
34は切除電極16まで続いている。第２の伝導線36は不関
パッチ電極18まで続いている。
実際の及び見かけ上のラジオ波電力のモニタ 図２及び図３に示すように、システム10は、発生器12
によって患者へ送達されるラジオ波電流及びラジオ波電
圧を測定するための第１のモニタ手段38を備えている。
第１のモニタ手段38はまた、RMS（二乗平均された）電
圧（単位ボルト）、RMS電流（単位アンペア）及び実際
の位相敏感電力（単位ワット）を示す制御信号を導出
し、発生器12の他の制御機能を支援する。
第１のモニタ手段38は、各種構造及び構成とすること
ができる。図示される実施例において、第１のモニタ手
段38は、第１の線34から組織を通って第２の線36へ通過
する（つまり、切除電極16から不関パッチ電極18への）
ラジオ波電流を測定するための電流モニタ手段40を備え
ている。
第１のモニタ手段38はまた、電圧モニタ手段42を備え
ている。電圧モニタ手段42は、第１及び第２の伝導線34
及び36の間（つまり、切除電極16と不関パッチ電極18と
の間）に発生されるラジオ波電圧を測定する。
第１のモニタ手段38は、３個の制御出力44、46及び48
を有している。第１の制御出力44は、切除電極16によっ
て伝導されるRMS電流を表す信号を伝える。
第２の制御出力46は、切除電極16と不関パッチ電極18
との間のRMS電圧を表す信号を伝える。
第３の制御出力48は、切除電極16によって伝送される
実際の位相敏感電力を表す信号を伝える。
図示される実施例において（図２及び図３に示すよう
に）、電流モニタ手段40は、第２の伝導線36において接
続される分離された電流感知変圧器50を有している。こ
の構成において、電流感知変圧器50は、切除電極16を通
して不関パッチ電極18へ通過するラジオ波電流を直接測
定する。
測定される値は選択された速度で変化するラジオ波信
号であり、図示される実施例においては500kHzである。
電流感知変圧器50は、第１の制御出力44へ接続されて
おり、RMS電流を求める。第１の制御出力44は、この機
能を行うための集積回路のRMSコンバータ52を備えてい
る。RMS電流コンバータは先ず、電流感知変圧器50から
のラジオ波電流入力信号を二乗し、次に、二乗された信
号をユーザ規定の期間にわたって平均化する（図示され
る実施例においては約0.01秒に一度である）。RMS電流
コンバータ52は次に、平均二乗値の平方根を取る。得ら
れる出力はRMS電流を表す。
RMS電流信号は、急速に変化するラジオ波電流入力信
号に比べて、比較的ゆっくりと変化する信号の形態をと
る。
図２及び図３に示すように、電圧モニタ手段42は、第
１及び第２の伝導線の間に接続される分離された電圧感
知変圧器54を備えている。この構成において、電圧感知
変圧器54は、切除電極16と不関パッチ電極18との間の身
体組織にかかるラジオ波電圧を直接測定する。
電流感知変圧器50によって測定される値と同様に、測
定された電圧値は、選択された500kHzの速度で変化する
ラジオ波信号である。
電圧感知変圧器54は、第２の制御出力46へ接続されて
おり、RMS電圧を求める。第２の制御出力46は、この機
能を行うための集積回路のRMSコンバータ56を有してい
る。RMS電圧コンバータ56は、ラジオ波電圧入力信号を
二乗し、次に、電流コンバータ52によって用いられる期
間と同一のユーザ規定期間にわたってそれを平均化す
る。次に、RMS電圧コンバータ56は、平均二乗電圧値の
平方根を取る。
得られるRMS電圧信号は、（RMS電流信号と同様に）、
比較的ゆっくりと変化する信号の形態をとる。
電圧感知変圧器54は、第３の制御出力48にも接続され
ており、実際の位相敏感電力を求める。第３の制御出力
48は、この機能を行うためのアナログ乗算器集積回路58
を有している。乗算器回路58は、一入力として、電流感
知変圧器50からのラジオ波入力電流信号を直接受け取
る。乗算器回路58は、第２の入力として、電圧感知変圧
器54からのラジオ波入力電圧信号を直接受け取る。
乗算器回路58の出力は、これら２つの入力の積であ
り、切除電極16によって伝送される実際のラジオ波電力
を表す。
電力値は（その成分電流及び電圧入力と同様に）、比
較的高いラジオ波の速度で変化するラジオ波信号であ
る。
第３の制御出力48は、ローパスフィルタ60も有してい
る。500kHzのラジオ波速度で動作する図示される実施例
において、フィルタ60の選択された遮断周波数は、約10
0Hzである。急速に変化する測定される入力電力値は、
フィルタ60によってローパスフィルタされ、比較的ゆっ
くりと変化する信号となる。
この信号は、切除電極16が目的の組織へ送達するラジ
オ波エネルギーの実際の位相敏感電力信号を表す。
第１、第２及び第３の制御出力44、46及び48は、それ
ぞれ、適切なインラインスケーリング回路62を備えてい
る。スケーリング回路62は、RMS電流信号、RMS電圧信
号、及び実際の位相敏感電力信号を、発生器12の残りの
回路構成によって使用可能となるような特定の電圧範囲
にスケールする。図示される実施例において、スケール
される範囲は0.0から5.0ボルトである。
第１のモニタ手段38は、アナログからデジタルへのコ
ンバータ64も備えている。コンバータ64は、アナログRM
S電流出力信号、RMS電圧出力信号、及び実際の位相敏感
電力信号のうち選択される１つ又はそれ以上をデジタル
化する。
コンバータ64の単数又は複数のデジタル出力は、測定
結果を表示するために用いられることができる。図示さ
れる実施例において、ユーザに実際の位相敏感電力信号
を示すために、システム10は、発生器12上に第１のデジ
タル表示装置66を備えている。
コンバータ64の単数又は複数のデジタル出力は、発生
器12の動作を制御するためにも用いられることができ
る。図示される実施例において、システム10は、切除電
極16でのラジオ波電力を制御するためにラジオ波出力電
圧を所望の範囲又は一定値に維持するフィードバックル
ープ内で、デジタル化された出力を用いる。発生器12に
よって送達される電力を制御することによって、医師
は、切除処置の間に、所望の深さの損傷を再現可能に形
成することができる。
この構成において、システム10は、発生器12のための
実際の位相敏感電力に対する所望の動作値をユーザが入
力するための入力装置68を備えている。システム10は、
電力制御手段70を備えている。電力制御手段70は、所望
の電力を実際の位相敏感電力と比較するための比較器71
を有している。比較器の出力は、測定される実際の電力
と設定値電力との間の誤差を最小に維持するように、ラ
ジオ波電力供給源30の出力電圧を変化させる。
図示される実施例において、電力制御手段70は、ラジ
オ波電圧と電流との間の位相差もモニタする。電力制御
手段70は、見かけ上の電力を計算し、計算された見かけ
上の電力を実際の位相敏感電力と比較することによって
この機能を行う。ラジオ波電圧信号と電流信号とが全く
同位相であれば、見かけ上の電力と実際の位相敏感電力
とは同一となる。しかしながら、位相差がある場合に
は、実際の位相敏感電力は、位相角の余弦を表す係数の
分だけ、見かけ上の電力とは異なっている。
図示される実施例において、電力制御手段70は、RMS
電流とRMS電圧の積を求める乗算器回路72を備えてい
る。乗算器回路72の得られる出力は、システム10の見か
け上の（つまり、位相敏感ではない）電力を形成する。
電力制御手段70は、得られる見かけ上の電力を実際の位
相敏感電力と比較するための比較器74を有している。比
較器74の出力の大きさは、位相シフトの量を表す。
位相シフト比較器74の出力が所定の量を越えると、電
力制御手段70は、ラジオ波電圧と電流との間に位相シフ
トが起こったことを示す警告信号を発生させる。システ
ム10は、ユーザに警告するために、点滅灯及びアラーム
音（不図示）を備えていることもできる。
電力制御手段70は、位相シフト比較器74の出力が閾値
量よりも上の許容可能な範囲内のままである場合には、
一定値の電力を維持するように動作する。電力制御手段
70は、位相シフト比較器74の出力がこの範囲を越えて増
大した場合には、供給源30の出力電圧を低下させるよう
に動作する。位相シフト比較器74の出力が最大閾値を越
える位相シフトを示す場合には、電力制御手段70は、切
除電極16への全ての電力を遮断するための信号を発生さ
せる。
組織インピーダンスのモニタ 図４に示すように、システム10は、切除を受ける組織
のインピーダンスを求めるための第２のモニタ手段76を
さらに備えている。第２のモニタ手段76は、組織のイン
ピーダンスを絶対項で求めるだけでなく、時間に伴う組
織インピーダンスの変化を記録するようにも機能する。
第２のモニタ手段76は、予めプログラムされた基準に
従って、組織インピーダンスの観測された絶対値及び感
知された変化に基づいて、適切な制御信号を発生させ
る。
第２のモニタ手段76は、各種構造及び構成とすること
ができる。図示される実施例において、第２のモニタ手
段76はマイクロプロセッサ78を備えている。マイクロプ
ロセッサ78は、所定の間隔で（例えば、20ミリ秒毎、50
Hzのサンプリングレートを表す）、アナログからデジタ
ルへのコンバータ64のデジタル化された出力をサンプル
する。
マイクロプロセッサ78は、また、サンプルされデジタ
ル化されたRMS電圧信号をサンプルされデジタル化され
たRMS電流信号で割る。数値結果は、サンプルに対する
組織インピーダンス（単位オーム）である。好ましく
は、システム10は、サンプルされた組織インピーダンス
をユーザに示す第２の表示装置80を発生器12上に有して
いる。
マイクロプロセッサ78は、また、時間に伴うサンプル
された組織インピーダンスの記録を維持する。この記録
から、マイクロプロセッサ78は、選択された間隔の間の
組織インピーダンスの変化を計算し、所定の基準に基づ
いて適切な制御信号を発生させる。
マイクロプロセッサ78が組織インピーダンスに基づい
て制御信号を発生させる際に基づく所定の基準は、変え
ることができる。好ましくは、組織インピーダンス制御
信号は、直前に説明した電力制御手段70のモニタ及び制
御機能を向上させるために用いられる。
図示される実施例において、測定された組織インピー
ダンスが所定の設定範囲外になると、マイクロプロセッ
サ78は、実際の位相敏感電力レベルがどのように感知さ
れても、切除電極16への電力を遮断するように命令信号
を発生させる。心臓の切除処置のための組織インピーダ
ンスに対する設定範囲は、約50〜300オームであると考
えられる。
組織インピーダンスが設定範囲から出発し、時間に伴
ってそれを越えて増大する場合、最も有り得る原因は、
切除電極16上での血液の凝固である。組織インピーダン
スが設定範囲を越えて突然上昇することは、凝固の突然
の開始、又は切除電極16の位置の急激なシフトを示唆す
る。組織インピーダンスの急速な変動はまた、切除電極
16と目的組織との間の接触状態が悪いことを示唆し得
る。全てが迅速な対応を要求する。例えば、切除電極16
の撤退及び洗浄、又は切除電極16の再配置である。
システム10は、これらの状態が起こった場合にユーザ
に警告を伝えるために、点滅灯及びアラーム音（不図
示）を備えていることが好ましい。
非常に高い組織インピーダンス値は、不関電極18の皮
膚への接触の悪さ、又はシステム10における電気的問題
を示唆し得る。この場合も、迅速な補正動作が要求され
る。
組織インピーダンスは設定範囲内であるが、範囲内の
所定量を越えて上昇する場合には、第２のモニタ手段76
が電力出力を中断するのではなく低下させる制御信号を
発生させる。この構成において、組織インピーダンスの
比較的狭い範囲（例えば、80〜150オーム）が設立され
ることができ、この範囲内の比較的一定の電力を維持す
る。
組織温度のモニタ 図５に示すように、システム10は、切除電極16に接触
している組織の温度を感知するための第３のモニタ手段
82を備えている。第３のモニタ手段82（図２にも示され
る）は、切除電極16に設けられている温度感知手段84を
有している。システム10は、発生器制御機能を実行する
ために感知された組織温度に応答する、発生器12のため
の制御手段86も備えている。
熱絶縁手段88は、温度感知手段84を切除電極16のサー
マルマス（thermal mass）から熱的に分離する。従っ
て、温度感知手段84は、切除電極16に熱を加えず、或い
はサーマルマスの一部にもならない。それは、接触して
いる組織の本当の温度を示すように働き、切除電極16の
サーマルマスへ熱を加えず、また、切除電極16の周囲の
サーマルマスの温度によっても影響を受けない。
図6AからＣに示される実施例において、切除電極16
は、その先端92に内部ウェル90を有している。温度感知
手段84がこのウェルを占める。
この構成において、熱絶縁手段88は、温度感知手段84
を、ウェル90の内部表面及び切除電極16のサーマルマス
の残りの部分から熱的に絶縁する。
図6AからＣにおいて、温度感知手段84は、２つの関連
するリード線96及び98を有する小さなビードサーミスタ
94を備えている。サーミスタ94の温度感知端は、組織へ
の接触のために切除電極16の先端92で露出されている。
図示される実施例において（図6AからＣを参照）、第
３のモニタ手段82は、異なるサーミスタ94の中で公称抵
抗のズレに対処するようにサーミスタ94を較正するため
の手段132（図２を参照されたい）を備えている。カテ
ーテル14の製造過程に、サーミスタ94の抵抗が、既知の
温度、例えば摂氏75度で、測定される。測定された値に
等しい較正抵抗器134が、カテーテルハンドル20内に組
み込まれる。（図１および図２を参照されたい）。較正
抵抗器134のリード線は、第３のモニタ手段82へ接続さ
れる。
図示されるタイプのサーミスタ94は、商品名111−202
CAK−BD1としてFenwal社（マサチューセッツ州）によっ
て市販されている。リード線96及び98は、＃36 AWG信号
配線Cu＋クラッド鋼鉄（重絶縁）からなる。
注型用樹脂100は、電極ウェル内にサーミスタ94並び
にリード線96及び98を封止している。絶縁被覆102は、
封止されたリード線96及び98もシールドしている。同時
に、樹脂100及び被覆102は、周囲の切除電極16からサー
ミスタ94を電気的に絶縁する。
注型用樹脂100及び絶縁被覆102は各種材料を用いて形
成され得る。図示される実施例において、ロックタイト
（loctite）接着剤は、注型用樹脂100として機能する
が、シアノアクリレート接着剤又はRTV接着剤なども用
いられ得る。被覆102は、ポリイミド（polymide）材料
からなるが、他の従来の電気絶縁材料もまた用いられ得
る。
図示される実施例において、熱絶縁手段88は、封止さ
れたサーミスタ94並びにリード線96及び98を包み込むチ
ューブ104を有している。熱絶縁チューブ104自体は、ウ
ェル90の内壁に接着される。
チューブ104の熱絶縁材料は変えることができる。図
示される実施例において、約0.003インチの厚さの壁を
有するポリイミド（polymide）材料である。マイラー又
はカプトン（kapton）などの他の熱絶縁材料も用いられ
得る。
サーミスタ94のためのリード線96及び98は電極ウェル
90からガイドチューブ22を通ってカテーテルハンドル20
内へ延びている。そこで、リード線96及び98は、ハンド
ル20から延びているケーブル28と電気的に結合してい
る。ケーブルプラグ（不図示）が発生器12と接続し、サ
ーミスタ94からの温度信号を第３のモニタ手段82へ伝達
する。
図7AからＣは、温度感知手段84のアレイを有する切除
電極16の他の実施例を示す。温度感知手段84の少なくと
も１つ、及び好ましくはそれらの全てが、図6AからＣに
示されるように切除電極16から熱的に分離されている。
図7AからＣに示すように、多数からなるアレイを有す
る例における切除電極16は内部コアウェル106を備えて
いる。５個のブランチウェル108A〜Ｅがコアウェル106
から延びている。ブランチウェル108A〜Ｅは切除電極16
の表面で開口している。１つのブランチウェル108Aが、
図6AからＣに示される単一の温度感知手段84と同様に、
切除電極16の先端で開口している。その他の４つのブラ
ンチウェル108B〜Ｅは、コアウェル106からある角度を
なして45度のアーチ状間隔で延びている。４つのブラン
チウェル108B〜Ｅは、切除電極16の側面で開口してお
り、先端ブランチウェル108Aを囲んでいる。
１つの温度感知手段84が、各ブランチウェル108A〜Ｅ
を占有している。図示される好ましい実施例において、
熱絶縁手段88は、各温度感知手段84を、関連するブラン
チウェル108A〜Ｅの内部表面及び切除電極16の残りのサ
ーマルマスから熱的に分離している。
図6AからＣに示される実施例と同様に、各温度感知手
段84は、２つの付随するリード線96及び98を有する小さ
なビードサーミスタ94を備えている。サーミスタ94の温
度感知端は、組織へ複数箇所で接触するために切除電極
16の先端で露出されている。付随するリード線96及び98
は、中央コアウェル106内で束にされ、ガイドチューブ2
2を通ってハンドル20へ延びている。
図6AからＣに示される実施例と同様に、注型用樹脂10
0は、各サーミスタ94及びそのリード線96及び98を、関
連するブランチウェル内に封止している。絶縁被覆102
も同様に、封止されたリード線96及び98をシールドして
いる。それと共に、樹脂100及び被覆102は各サーミスタ
94を周囲の切除電極16から電気的に絶縁している。
図6AからＣに示される実施例と同様に、熱絶縁チュー
ブ104は、各電気的に封止されたサーミスタ94及びその
リード線96及び98を包み込んでいる。さらに、図6Aから
Ｃに示される実施例と同様に、接着剤が、各熱絶縁チュ
ーブ104を各ブランチウェル108A〜Ｅの内壁へ接着して
いる。
図8AからＣは、多数の温度感知手段84を有する切除電
極16のさらに他の実施例を示す。
図8AからＣに示される構成において、切除電極16は、
前記電極部110及び後方電極部112を有している。前方電
極部110及び後方電極部112は、一般的に球は形状であ
る。
電気的及び熱的絶縁スリーブ114は、前方電極部110と
後方電極部112とを分離する。スリーブ114は、一般的に
筒状の形状である。得られる「ピーナツ」型は、心臓の
弁の部分内での使用に非常に適している。
図示される実施例において、前方電極部110及び後方
電極部112はプラチナからなる。スリーブ114はポリスル
ホン材料からなる。
多数の温度感知手段84が前方及び後方電極部110及び1
12の各表面を占有する。温度感知手段84の少なくとも１
つ、好ましくは全部が、関連する電極部110及び112の周
りの本体の残りの部分から熱的に絶縁されている。
各電極部110及び112は、関連する電極部110及び112の
表面で開口している内部コアウェル116及びブランチウ
ェル118を有している。温度感知手段84が各ウェルブラ
ンチを占有している。図示される好ましい実施例におい
て、熱絶縁手段88は同様に、各温度感知手段84を、関連
するブランチウェル116及び118の内部表面並びに電極部
110及び112のサーマルマスの残りから分離する。
図6AからＣに示される実施例と同様に、各温度感知手
段84は、２つの関連するリード線96及び98を有する小さ
なビードサーミスタ94を有している。サーミスタ94の温
度感知端は、組織に複数箇所で接触するために、関連す
る電極部110及び112の表面で露出している。関連するリ
ード線96及び98は、内部コアウェル116内で束にされ、
ガイドチューブ22を通ってハンドル20へ延びている。
前述の実施例と同様に、注型用樹脂100が各サーミス
タ94及びそのリード線96及び98を関連するブランチウェ
ル116及び118内に封止している。絶縁被覆102も、封止
されたリード線96及び98をシールドしている。また、前
述の実施例と同様に、熱絶縁チューブ104が電気的に封
止された各サーミスタ94及びそのリード線96及び98を包
み込んでいる。接着剤が、熱絶縁チューブ104を各ブラ
ンチウェル116及び118の内壁へ接着している。多数の温
度感知手段84の可能なアレイの数及び構成は、図６、図
７及び図８に示される特定の構造から変えることができ
ることはもちろんである。例えば、１個又はそれ以上の
温度感知手段84が切除電極16の先端の下の側部を占有す
ることもできる。温度感知手段84を保持するブランチウ
ェルも、様々な角度、鋭角、鈍角又は直角で、中央ウェ
ルから延びることができる。全ての温度感知手段84が電
極16から熱的に分離される必要はないが、全てが熱的に
分離されることが好ましい。
図５に示すように、第３のモニタ手段82は、異なる所
定基準に従って感知された温度状態に応じて、異なる表
示及び制御機能を行うことができる。
好ましくは、第３のモニタ手段82は、感知された組織
温度の絶対項に応答するだけでなく、時間に伴う組織温
度の変化を記録し、これらの変化に応答するようにも機
能する。
図示される実施例において、第３のモニタ手段82は、
関連する切除電極16に設けられる各温度感知手段84のた
めの制御出力120を有している。
各サーミスタ94のためのリード線96及び98は、制御出
力120のための入力を供給する。或いは、切除電極16に
多数のサーミスタ94を設けた場合には、ガイドチューブ
22を横切るリード線96及び98の数は、サーミスタ94の入
力信号をマルチプレックス化するための集積回路122を
第３のモニタ手段82内に設けることによって低減するこ
とができる。
図示される実施例において、第３のモニタ手段82は、
ユーザ規定の期間の間に（図示される実施例においては
約0.01秒毎に一回）サーミスタ94の各アレイグループに
対する平均温度を求めるためのコンバータ124を備えて
いる。
図6AからＣに示される実施例は、１つのサーミスタ94
を備えているので、入力信号と平均とは同一である。
図7AからＣに示される実施例は、切除電極16の先端に
集められた５個のサーミスタ94の単一アレイグループを
備えている。このアレイに対して、コンバータは個々の
入力信号を加算して５で割る。
図8AからＣに示される実施例は、２つのアレイグルー
プを備えており、一方は前方電極部110上に５個のサー
ミスタ94を有しており、他方は後方電極部112上に４個
のサーミスタ94を有している。コンバータ124は、各ア
レイグループの入力信号を加算して、各アレイグループ
内のサーミスタ94の関連する数で割る。これによって、
前方電極部110の平均と、後方電極部112の平均とがそれ
ぞれ得られる。
第３のモニタ手段82は、アナログからデジタルへのコ
ンバータ126（図5Aを参照されたい）を有している。コ
ンバータ126は、システム10に対して感知された単数又
は複数の温度平均をデジタル化する。
コンバータ126は、較正抵抗器134の値もデジタル化す
る。サーミスタ抵抗値は、較正抵抗値で割られ、サーミ
スタ94のための規格化された抵抗が得られる。この値
は、格納されたサーミスタ温度データを有している読み
出し専用メモリ（ROM）136（図5B参照）への入力であ
る。ROM136の出力は、実際に測定された組織温度（単位
摂氏）であるので、サーミスタ94の公称抵抗のズレが考
慮される。
図示されていないが、多数のサーミスタ94を有する実
施例は、同数の較正抵抗器134、つまり各サーミスタ94
に対して１個、を備えている。
コンバータの単数又は複数のデジタル出力は測定結果
を表示するために用いられ得る。図示される実施例にお
いて、システム10は感知された温度の平均をユーザに示
すために、発生器12上に第３のデジタル表示装置128を
備えている。
図8AからＣに示される「ピーナツ」型電極が用いられ
る場合、システム10は、前方及び後方電極部110及び112
のための別個の表示装置を備えている。
コンバータ126の単数又は複数のデジタル出力は、発
生器12の制御動作のためにも用いられる。好ましくは、
第３のモニタ手段82の温度制御信号は、前述の第１及び
第２のモニタ手段38及び76の機能をさらに向上させるた
めにも用いられる。
図示される実施例において、システム10は、切除電極
16でのラジオ波電力を制御するために、所望の範囲内又
は一定値にラジオ波出力電圧を維持するフィードバック
ループにおいて、デジタル化された温度出力を用いる。
温度に基づいて発生器12によって送達される電力を制御
することによって、医師は、発生される損傷の大きさを
制御することができる。
この目的のために、システム10は、組織温度のための
所望の動作値をユーザが入力するための入力装置130を
備えている。
組織温度が所定範囲内であるが、範囲内で所定量だけ
ずれる場合には、第３のモニタ手段82は、電力出力を遮
断はせずに、増大又は低下させる制御信号を発生させ
る。組織温度が上昇する場合には、制御信号が電力出力
を低下させる。組織温度が低下する場合には、制御信号
が電力出力を増大させる。測定される組織温度が所定範
囲外になった場合には、第３のモニタ手段82が、切除電
極16への電力を遮断する命令信号を発生させる。心臓の
切除のための組織温度の代表的な設定範囲は、約摂氏40
度から100度であると考えられる。
温度が設定範囲内から出発し、時間と共にその範囲外
となる場合には、その最も有り得る原因は、切除電極16
上での血液の凝固であり、切除電極16の撤退及び洗浄が
必要である。組織温度の設定範囲外への急な変化は、切
除電極16の位置のシフトを示唆しており、切除電極16を
再配置することが必要である。
システム10は、これらの温度による状況が発生した場
合に、ユーザへ警告を伝えるために、点滅灯及びアラー
ム音（不図示）を備えていることが好ましい。
上述の様に、システム10は、切除処置にわたって正確
な制御を提供することができる。実際の位相敏感電力の
モニタ及び制御は、切除電極16へのラジオ波の有効な伝
送を確実とする。組織インピーダンス及び組織温度のモ
ニタ及び制御は、それぞれ別個に、又は組み合わせて、
損傷の大きさ及び凝固の検出の点での生理学的な安全上
の制限を設定する。組織インピーダンス及び／又は組織
温度のモニタ及び制御は、切除電極16の向きに関する情
報も提供する。
───────────────────────────────────────────────────── フロントページの続き (72)発明者 スターン，ロジャー エイ. アメリカ合衆国 カリフォルニア 95014，カパーティーノ，パロ ビスタ ロード 10418 (56)参考文献 特開 平３−92144（ＪＰ，Ａ) 米国特許4960109（ＵＳ，Ａ) 米国特許4899741（ＵＳ，Ａ) 米国特許4785824（ＵＳ，Ａ) 国際公開91／016859（ＷＯ，Ａ１) 西独国特許出願公開3838840（ＤＥ, Ａ１) (58)調査した分野(Int.Cl.7，ＤＢ名) A61B 18/00 - 18/28 A61N 1/00 - 7/00

Claims (15)

    (57)【特許請求の範囲】
  1. 【請求項１】電気的導電性材料から形成されたエネルギ
    ー放出体であって、エネルギーを組織に送ることにより
    該組織を切除するエネルギー放出体と、 該エネルギー放出体の内部にあるウェルであって、該エ
    ネルギー放出体の外部から該エネルギー放出体の内部に
    至るように形成されたウェル内に配置され、該組織の温
    度を感知する温度感知手段と、 該エネルギー放出体と該温度感知手段との間にある該ウ
    ェル内に配置され、該温度感知手段と該エネルギー放出
    体との間での熱エネルギーの移動を遮断する熱絶縁手段
    と を備えている切除電極。
  2. 【請求項２】前記温度感知手段が、前記エネルギー放出
    体上に設けられた１つよりも多くの温度感知素子を有し
    ており、 前記熱絶縁手段が、該温度感知素子の少なくとも１つと
    連結されている、 請求項１に記載の電極。
  3. 【請求項３】前記熱絶縁手段が、前記温度感知素子の全
    てと連結されている、請求項２に記載の電極。
  4. 【請求項４】前記温度感知手段がサーミスタを有してい
    る、請求項１に記載の電極。
  5. 【請求項５】前記温度感知手段がサーミスタを有し、 前記熱絶縁手段が、該サーミスタを覆う熱絶縁チューブ
    である、請求項１に記載の電極。
  6. 【請求項６】切除エネルギーの供給源と、 組織と接触し、該切除エネルギーを該組織に放出する電
    極手段と を備えている組織を切除するシステムであって、 該電極手段が、 電気的導電性材料から形成されたエネルギー放出体であ
    って、エネルギーを組織に送ることにより該組織を切除
    するエネルギー放出体と、 該エネルギー放出体の内部にあるウェルであって、該エ
    ネルギー放出体の外部から該エネルギー放出体の内部に
    至るように形成されたウェル内に配置され、該組織の温
    度を感知する温度感知手段と、 該エネルギー放出体と該温度感知手段との間にある該ウ
    ェル内に配置され、該温度感知手段と該エネルギー放出
    体との間での熱エネルギーの移動を遮断する熱絶縁手段
    と、 該温度感知手段を用いて組織温度を測定するモニタ手段
    と を有しているシステム。
  7. 【請求項７】前記モニタ手段によって測定された前記温
    度に基づいて制御信号を発生する制御手段をさらに有し
    ている、請求項６に記載のシステム。
  8. 【請求項８】前記モニタ手段が、測定された組織温度の
    時間に対する変化を記録する、請求項６に記載のシステ
    ム。
  9. 【請求項９】前記温度感知手段が、前記エネルギー放出
    体上に設けられた１つよりも多くの温度感知素子を有し
    ており、 前記熱絶縁手段が、該温度感知素子の少なくとも１つと
    連結されており、 前記モニタ手段が、該温度感知手段の全てを用いて前記
    温度を測定する、 請求項６に記載のシステム。
  10. 【請求項１０】前記モニタ手段が、前記温度感知手段か
    らの信号をマルチプレクス化する手段を有している、 請求項９に記載のシステム。
  11. 【請求項１１】測定された前記温度を、ユーザが判読で
    きる形式で表示する手段をさらに有している、 請求項６に記載のシステム。
  12. 【請求項１２】電気絶縁化合物が前記ウェル内に設けら
    れ、かつ前記温度感知手段と該ウェルの内壁に設けられ
    た前記熱絶縁手段との間に配置される、請求項１に記載
    の電極。
  13. 【請求項１３】電気絶縁化合物が前記ウェル内に設けら
    れ、かつ前記温度感知手段と該ウェルの内壁に設けられ
    た前記熱絶縁手段との間に配置される、請求項６に記載
    のシステム。
  14. 【請求項１４】前記熱絶縁手段が前記ウェルの内壁に設
    けられる、請求項１に記載の電極。
  15. 【請求項１５】前記熱絶縁手段が前記ウェルの内壁に設
    けられる、請求項６に記載のシステム。
JP50874193A 1991-11-08 1992-11-05 絶縁された温度感知素子を有する切除電極 Expired - Lifetime JP3530528B2 (ja)

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US79057891A 1991-11-08 1991-11-08
US07/790,578 1991-11-08
PCT/US1992/009555 WO1993008755A1 (en) 1991-11-08 1992-11-05 Ablation electrode with insulated temperature sensing elements

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JP3530528B2 true JP3530528B2 (ja) 2004-05-24

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US5688266A (en) 1997-11-18
EP0566725A1 (en) 1993-10-27
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AU3067292A (en) 1993-06-07
EP0566725A4 (en) 1995-02-22
CA2106410C (en) 2004-07-06
US5897552A (en) 1999-04-27
US5456682A (en) 1995-10-10
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EP0566725B1 (en) 2003-06-04
DE69233091T2 (de) 2004-05-06
CA2106410A1 (en) 1993-05-09
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ATE241938T1 (de) 2003-06-15

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