JP2647557B2 - Ｂｐｈ切除方法及び装置 - Google Patents

Ｂｐｈ切除方法及び装置

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Publication number
JP2647557B2
JP2647557B2 JP6525623A JP52562394A JP2647557B2 JP 2647557 B2 JP2647557 B2 JP 2647557B2 JP 6525623 A JP6525623 A JP 6525623A JP 52562394 A JP52562394 A JP 52562394A JP 2647557 B2 JP2647557 B2 JP 2647557B2
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JP
Japan
Prior art keywords
temperature
tissue
high frequency
frequency power
prostate
Prior art date
Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
Expired - Fee Related
Application number
JP6525623A
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English (en)
Other versions
JPH08508664A (ja
Inventor
スチュアート ディー エドワーズ
ヒュー アール シャーキー
インゲマー エイチ ランドキスト
ロナルド ジー ラックス
ブルーノ ストラル
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BIIDAMETSUDO Inc
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BIIDAMETSUDO Inc
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Publication of JPH08508664A publication Critical patent/JPH08508664A/ja
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Publication of JP2647557B2 publication Critical patent/JP2647557B2/ja
Anticipated expiration legal-status Critical
Expired - Fee Related legal-status Critical Current

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Description

【発明の詳細な説明】 関連特許出願 本発明は、1992年８月12日に出願された特許出願第07
/929,638号及び1993年２月２日に出願された特許出願第
08/012,370号の一部継続出願であり、上記特許出願の全
ての内容を参考としてここに援用する。
発明の分野 本発明は、良性前立腺肥大症又は増殖症（BPH）を処
置するために制御された熱を与えて切除を行うための独
特な方法及び装置に関する。この方法及び装置は、上記
の関連特許出願に開示されたような装置が貫通した組織
へ上記の制御された熱を付与するものである。
先行技術の説明 通常、細胞組織を処置する場合には、目標組織及び介
在組織の両方を実質的な外傷に曝す外科的な手順により
目標組織に医療器具を直接接触させることが必要であ
る。処置用プローブを正確に配置することは、しばしば
困難である。というのは、人体内の目標組織の位置又は
目標組織の付近には、損傷を受け易い重要な人体器官、
神経又は他の要素があるからである。
例えば、良性前立腺肥大症又は増殖層（BPH）は、50
歳以上の男性が経験する最も一般的な医療問題の１つで
ある。前立腺増殖による尿管閉塞は、医学の初期から認
識されている。前立腺の増殖肥大は、しばしば尿管の圧
縮を招き、尿管の閉塞を生じると共に、その後に、頻
尿、尿量の減少、痛み、不快感及び尿滴下を含む症状が
発生する。BPHと年齢との関係は、50歳以上の男性では
発病率が50％を越えそして80歳以上の男性では75％以上
に増加する。尿管閉塞の症状は、65歳ないし70歳の年齢
で最も頻繁に発生する。というのは、この年齢の男性の
約65％が前立腺肥大だからである。
現在、非外科的なBPH処置方法で、有効性が証明され
た処置方法は、皆無である。更に、利用できる外科的手
順は完全に満足なものではない。現在、この疾病の閉塞
症状にかかっている患者は、その症状にうまく対処し続
ける（即ち保存療法）か、早期段階で薬剤療法を受ける
か、又は外科的介入を受けるかといった幾つかの選択肢
が与えられている。米国内では、毎年３万人以上の患者
が前立腺組織を除去するための手術を受けている。これ
は、医療的に重大な症状を示している男性の数％未満に
過ぎない。
BPHにかかっている人は、ほとんどが年配の男性であ
り、その多くは外科手術の危険性を高めるような付加的
な健康上の問題を伴っている。前立腺組織を除去するた
めの外科手順は、麻酔に関連した罹病、出血、凝血異
常、肺閉栓症及び電解質アンバランスを含む多数の危険
性を伴う。又、現在行われているこれらの手順は、心臓
合併症、膀胱穿孔、失禁、感染症、尿道又は膀胱頸狭窄
症、前立腺片のうっ帯、逆行性射精、及び不妊症を招く
こともある。閉塞性尿路障害に対する現在の処置選択肢
は、著しく侵入性のものであるために、大部分の患者は
それらの症状についての決定的な処置を遅らせる。この
ような状況は、前立腺における閉塞性病巣に対して二次
的な構造部に重大なダメージを及ぼし（膀胱肥大症、水
腎症、腎盂症の拡大、等）、これは、重大な結果を伴わ
ないではない。更に、外科的な介入を保証するには甚だ
厳しい症状をもつ相当数の患者は、手術危険度が少な
く、前立腺摘出の候補にもなり難い。更に、BPHにかか
っている若い男性で、不妊症のような合併症の危険を冒
したくない人は、外科的な介入をしばしば回避させられ
る。従って、BPHを処置する改良された外科的及び非外
科的方法の必要性、重要性及び価値については、疑う余
地がない。
特に、無血切開が所望されるか、又は手術位置が通常
の小刀では届かないが、食道や腸や尿道のような自然の
人体孔を経て細い器具で届くときには、人体組織を切除
する電気メス（焼灼）手順に高周波電流が使用される。
その例としては、前立腺腫、膀胱腫瘍又は腸ポリープの
除去が含まれる。このような場合に、高周波電流は、外
科プローブによって切除されるべき組織へ供給される。
それにより生じる発熱で、その点の細胞流体が沸騰及び
蒸発し、その際に、細胞壁が破壊して組織が分離され
る。
細胞組織の破壊は、本来、多数の疾病及び医学的症状
の処置それ自体に使用されるか又は外科的除去手順の付
属手段として使用されている。これは、ほとんどの場合
に外科的手順よりも外傷が少なく、他の手順では危険で
ある場合の唯一の代替え手段である。切除処理装置は、
破壊的なエネルギーを使用するが、これは循環する流体
の導通及び対流力、並びに他の自然の人体プロセスによ
って急激に消散されて非破壊的レベルへ減少されるとい
う利点を有する。
又、悪性、良性及び他の形式の細胞及び組織を種々様
々な解剖学的場所及び器官から破壊するために、マイク
ロ波、高周波、音波（超音波）及び高エネルギー（レー
ザ）装置が使用されている。処置される組織は、分離さ
れた癌性の塊、より詳細には、前立腺のような器官、良
性前立腺増殖症の腺状及び基質状小節特徴を含む。これ
らの装置は、通常、カテーテル又はカニューレを含み、
これは、管を通して処置ゾーンへ高周波電極又はマイク
ロ波アンテナを搬送しそして管壁を経て周囲の組織へ全
方向にエネルギーを拡散的に付与するのに使用される。
この細胞破壊プロセス中には管壁に激しい外傷をしばし
ば受け、ある装置は、管壁に対する外傷を減少するため
にマイクロ波アンテナに冷却システムを組み合わせてい
る。これら装置で前立腺を処置する場合には、例えば、
尿道の壁を経て周囲の前立腺細胞へ熱エネルギーが付与
され、尿道を圧縮している組織が殺される。通常は、レ
ーザからの光エネルギーが、尿道の壁を「焼き切る」こ
とにより前立腺組織の目標位置へ付与される。管壁の健
康な細胞及び小節と管壁との間の健康な組織も、このプ
ロセス中に区別なく破壊され、ある程度の前立腺機能が
不必要に失われることになる。更に、あるマイクロ波装
置の追加冷却機能は、装置を複雑にする上に、この冷却
システムを受け入れるために装置が充分大きくなければ
ならないことになる。
医療目的で特定の組織に液体を付与することは、介在
する組織に外傷を生じることなく付与しそしてその特定
の目標組織に限定して付与する能力によって制限され
る。局部的な化学療法、薬剤注射、コラーゲン注入、或
いは光、熱又は化学薬品により活性化される薬の注入
は、特定の目標組織で開放する流体供給カテーテルを便
利に且つ正確に配置する装置によって著しく容易にな
る。
発明の要旨 本発明の主たる目的は、介在する組織を実質的に加熱
したり又は影響を及ぼしたりすることなく介在する組織
を通して目標組織へ制御された熱を付与する方法及び装
置を提供する。目標組織は、組織破壊のような医療処置
に対して選択される。破壊は、外傷を最小にすると共に
著しい医療効果を達成するために正確に予め選択された
位置に限定される。
本発明の他の主たる目的の１つは、治療エネルギーを
目標組織へ直接付与する一方、その周囲組織への影響を
最小にすることにより、人体組織を正確に組織破壊する
ための方法及び装置を提供することである。
本発明の別の目的は、周囲環境が所定の温度を越えた
ときに遮断するように自動的に制御される熱的破壊方法
を提供することである。
本発明の別の目的は、特定の周波数レンジに限定され
ると共に予め選択された時間中特定の電力範囲に限定さ
れた電力を付与して、目標組織に対する隣接組織の温度
を制御し、そして付与エネルギーが前立腺付近の人体器
官に影響しないと共に上記前立腺付近の神経系要素にも
影響しないように電力付与のパラメータを与えるような
システムを提供することである。
本発明の更に別の目的は、カテーテルを通して供給さ
れるべき選択された電圧及び選択された周波数レンジに
おいてRF電力をタイミングを合わせて付与することであ
る。使用するカテーテルの形式は、少なくとも１つの針
ポートを側壁に有する針ガイドハウジングと、上記針ポ
ートを通して外方にそして目標組織に向かって所定の角
度で介在組織を通して柔軟な針を案内するガイド手段と
を有するプローブを備えている。
又、本発明の目的は、柔軟な針の近位端及び針ポート
の近位端に取り付けられた熱センサを使用することによ
りカテーテルのプローブ端の環境温度を監視する方法及
びシステムであって、上記センサの各々が温度の表示を
指示するフィードバックを与えるような方法及びシステ
ムを提供する。又、本発明は、いずれかのセンサの温度
が各センサに対する各所定の最大値を越えたときにRF電
力を遮断する。
又、本発明の目的は、付加的なセンサを使用して人体
の隣接部分に対するRF電力付与の作用を監視するように
して患者の人体の隣接器官の温度測定を行うことであ
る。
本発明の更に別の目的は、電力の校正付与に基づいて
電圧を付与するシステム及び方法であって、上記校正を
人体の典型的なインピーダンスに基づいて行うようなシ
ステム及び方法を提供することである。
本発明の更に別の目的は、所定の時間中制御されたRF
電力を付与する方法であって、RF電圧を付与するカテー
テルをすぐ近くの環境内及び前立腺領域に隣接する人体
器官内の安全な温度範囲に基づいて自動的にスイッチオ
フを行う方法を提供することである。
図面の簡単な説明 図１は、男性の下腹部を示す解剖学的な断面図で、カ
テーテル及び前立腺プローブの配置を示し、本発明の方
法の好ましい実施形態に基づいてカテーテルが電力を付
与する状態を示した図である。
図２は、本発明の電力付与を用いたRF切除カテーテル
の２針実施形態を示す上面図である。
図2Aは、図２の各針をカバーする非導電性スリーブの
側面図である。
図３は、本発明の方法による付与システムの電源を示
す回路図である。
図４は、本発明による電力付与システムのフロントパ
ネルを示す図である。
好ましい実施例の詳細な説明 本発明の方法は、処置又は破壊の目標となる組織にRF
エネルギーを正確に制御して付与する。発生された電力
は、カテーテルのポートから正常な組織を経て目標組織
へ通される内実又は中空のプローブを含む針を備えたカ
テーテルによって付与される。典型的に、針は、上記特
許出願第07/929,638号及び08/012,370号に開示された形
式のものである。針は、組織を容易に安全に通過する形
状にされ、細いワイヤ又はロッドで構成されてもよい
し、或いは細い中空のチューブであるか又は流体を導入
したり材料を除去したりするための長手方向の内腔をも
つ他の形状であってもよい。針は、通常は、組織を通し
て目標位置へ押し込むときに抵抗がないように先鋭に形
成されるのが好ましい。針は、本発明によれば、高周波
電極として設計される。
本発明の方法は、人体全体の医療目標となる組織の細
胞を破壊するための改良された高精度の制御の医療処置
を提供する。上記細胞は、特定の人体器官の内部にあっ
てもよいし外部にあってもよい。より詳細には、良性前
立腺増殖症（BPH）を処置するのに有用な電力を付与す
る方法及び装置が提供され、そして好ましい実施態様で
述べる装置及びその使い方は、特に、BPHについて構成
されたものである。しかしながら、当業者に明らかなよ
うに、この装置及び方法は、経皮又は内視鏡カテーテル
により接近できる人体組織、並びに他の人体空洞又は組
織位置を破壊するのにも使用でき、前立腺に限定される
ものではない。装置及び方法を全てのこれら器官及び組
織に適用することは、本発明の範囲内で意図される。
BPHは、前立腺において細胞の良性の複製及び成長が
生じて腺状及び基質状の小節を形成し、これが前立腺を
膨張させそして尿道の開きを圧縮する状態である。腺状
の小節は主として遷移領域に集中しそして基質状の小節
は尿道周囲領域に集中する。この状態の慣例的な処置
は、前立腺全体を外科手術で除去したり、腺腫を指で除
去したり、尿道管及び前立腺の経尿道切除を行って組織
を除去すると共に通路を広げることを含む。この後者の
方法に関連した１つの顕著な重大な複雑さは、医原性の
不妊症である。最近、組織を除去し、出血や体液の損傷
を制限するためにレーザ処置が適用されている。又、熱
を加えたり加えなかったりして尿道内でバルーンを膨ら
ませてその直径を広げているが、これには重大な制約が
あることが分かっている。
マイクロ波療法も提供され、尿道内にマイクロ波アン
テナを配置しそしてマイクロ波電界で尿道の周りの組織
に熱を発生することによりある程度の成功を収めてい
る。尿道壁の温度を下げるためにカテーテルシャフト内
に冷却材が入れられることもある。これは、すぐ近くの
組織を冷却すると同時に更に離れた補綴組織に熱を発生
するための複雑な機構を必要とする。この技術は、マイ
クロ波の温熱療法に類似している。同様に、電極が尿道
内に配置された状態での高周波組織破壊は、当然ながら
尿道壁を破壊温度に曝すことになるので、その適用が限
定される。これを回避するために、尿道を保護する低い
温度設定が必要とされるが、これは、有用な作用を生じ
るに要する処置時間が、例えば、３時間までのエネルギ
ー付与といった不当な長さになる程、低い温度でなけれ
ばならない。
本発明の好ましい実施態様では、尿道を利用して前立
腺に接近し、破壊されるべき組織又は小節にRF針を直接
位置設定する。尿道から目標組織へと延びる針導体の部
分は、長手方向に調整できるスリーブ内に包囲され、こ
のスリーブは、それに隣接する組織がRF電流に曝される
のを防止する。それ故、切除破壊は、破壊の目標となる
組織、即ち狭窄を生じる組織に限定される。より詳細に
は、本発明によれば、電極針に電力を付与する方法は、
電力範囲及び周波数範囲内に制御され、そして針の近位
端に配置された一連の温度センサにより周囲組織の完全
な保護を確保するように制限される。これは、センサの
いずれか１つが処置領域に対する所定の安全温度を越え
たことを感知した際にシステムへのRFエネルギーを自動
的に遮断することにより可能となる。又、この方法は、
処置される組織に隣接した人体器官の付近に配置された
付加的なセンサを用いて自動的に電力を遮断し、上昇し
た器官温度によりこれら隣接する人体器官へダメージが
及ぶのを回避することも特徴とする。
図１は、本発明の方法及び装置により発生されて送ら
れる制御されたエネルギーを処置組織へ付与するための
典型的な装置を使用する間の男性下腹部の解剖学的な概
略断面図である。尿道２は、膀胱４から前立腺６及び尿
生殖隔膜８を経て延びている。BPHとは、前立腺尿道の
一部分が主として前立腺における良性の腺細胞及び基質
細胞の増殖により収縮することを特徴とする症状であ
る。これらの小節は、尿道壁を内方に押して尿道直径を
制限し、時には正常な組織を外方に押して前立腺を肥大
することもある。慣例的な処置は、前立腺の除去を除く
と、切除又はレーザ組織破壊によるか、又は尿道の周囲
の組織を膨張しそしてそれを細胞損傷を生じる温度まで
加熱することによりその内腔を広げるように尿道から組
織を除去することを含む。この後者の方法は、前立腺の
腫大又は肥大を減少しそして尿通路をその前の直径の少
なくとも一部分まで回復させるよう意図されている。
針ガイド16をもつカテーテル14は、尿道を経て前立腺
へ下方に通される。ガイド16の位置は、例えば、肛門22
を経て前立腺付近の直腸20に挿入された従来の超音波ト
ランスジューサ18から受け取った信号から得た超音波像
を用いて正確に制御される。このガイドは、針17を超音
波造影のもとで正確な位置に容易に位置設定できるよう
にする。又、ガイド18は、以下に述べるように、組織を
加熱することによる影響を腸領域内で感知するために、
センサ37、38及び39を含むことができる。任意である
が、これらセンサ37、38及び39は、超音波プローブを除
去した後であって且つカテーテル14及び針ガイド16を位
置設定した後に直腸領域に配置される個別の器具の一部
分であってもよい。図１は、２本の針306及び308を示
し、針306は、その端が、切除されるべき組織を表す組
織領域170に貫通されている。
図２は、本発明の好ましい方法及び装置により電力を
付与するのに使用される図１の切除カテーテルの２針実
施形態を示す上面図である。取手302に取り付けられた
柔軟なカテーテル300は、２本の針306及び308をもつ端
子針ガイド304を有している。又、取手は、針スリーブ
キャップ356及び電極キャップ354を有する。又、取手
は、以下に詳細に述べるRF電源コネクタ303にも接続さ
れる。サーモコネクタ307に対する接続も示されてい
る。取手302から針ガイド304へ延びるカテーテル300の
部分は、段階的なスチフネスを有することも任意であ
る。例えば、カテーテルは、取手付近でスチフネスが高
くそして尖端付近で柔軟であるように設計することもで
きるし、又は他の所望のスチフネスプロファイルをもつ
こともできる。カテーテルは、参考としてここに取り上
げる1991年８月11日出願の米国特許出願第790,648号に
開示されたように、内側のスロット付きのステンレスス
チール管と、外側の柔軟なスリーブとで構成することが
できる。又、カテーテルは、コイル又は編組線で形成し
てそこに外側スリーブを接着したものでもよい。図２の
針は、1993年２月２日に出願された特許出願第08/012,3
70号に開示されている。
本発明の電力付与方法は、図３の回路図に示された電
力供給付与システムによって可能になる。
210で示されたブロックは、患者と、図１と同様に挿
入された針ガイド16及びセンサ37、38、39を有するトラ
ンスジューサプローブ18との接続を示している。針ガイ
ド16は２本の針を有し、図示されたセンサ241及び243
は、針の付近に各々取り付けられる。特に、好ましい実
施形態では、図２の針306、308は、各々、図2Aに示すよ
うな非導電性スリーブを含んでいる。この非導電性スリ
ーブは、前記特許出願第08/012,370号に詳細に説明され
ている。本発明の目的に対し、この非導電性スリーブ
は、テーパ付けされた導入尖端262と、堅固な近位部分2
64とを有している。非導電性スリーブ202の中心部分即
ち内腔274は、針306、308を受け入れる。温度センサ241
が尖端に取り付けられる。図３に概略的に示された取付
部243は、他方の針に対応し、センサ241の配置と同一で
ある。針ガイドの第３のセンサが242で示されており、
ガイド内の表面付近の配置に対応する。針ガイドは、３
つのセンサ241−243と共に示されており、これらセンサ
は、分離装置231−233を経て各々温度信号を送信し、各
々221、222及び23に温度測定値を与える。
針306及び308の加熱は、図３に概略的に示されたクリ
スタル発振子102及び変圧器回路104によるRF電力の発生
によって達成される。好ましい実施形態では、クリスタ
ル発振子は、482KHzのrf電力を針ガイド、ひいては、針
306及び308へ各々効果的に供給する。変圧器回路は、10
0オームのインピーダンスに対して校正されている。こ
のインピーダンスは、尿道に針を配置した状態での典型
的な患者の測定において予想される中程度のインピーダ
ンスに基づくものである。図３の回路の実際の動作にお
いては、インピーダンスは校正されたインピーダンスか
ら変化し、これは回路204によって測定される。rfエネ
ルギーの付与は単極性であるから、各患者は回路を完成
するために中性電極206をもたねばならない。典型的
に、これらの電極は、患者の背中に配置されて接着剤で
保持される大きなパッチ電極である。
好ましい構成においては、変圧器回路は、16ワットで
あるが、BPHで遭遇する分離組織切除のための通常の付
与範囲は、５ないし７ワットで、通常はこれが３分で付
与される。
オペレータの設定並びに周波数及び電力の最大値はさ
ておき、回路の動作に関する限界は、針ガイド16に関連
したセンサ241、242及び243と、直腸プローブ16に関連
したセンサ37、38及び39によって決定される。これらセ
ンサ241、242、243及び37、38、39からの出力の処理
は、分離装置231ないし236及び温度測定回路221ないし2
26によって各々示されたように同一である。分離装置23
1−236は、1500ボルトの分離回路を含み、これは好まし
い実施形態ではバー・ブラウン分離装置ISO 122JPであ
る。この分離装置231−236からの出力は、冷接点補償回
路271−276を経て温度測定回路221−226及び温度カット
オフ回路211−216へ送られる。分離装置231−236の各々
は、温度測定装置221−226と同様に、同一のものであ
る。各冷接点補償構造体271−276は、絶対温度測定値の
読みを℃で与える。回路は、温度カットオフ回路211−2
16の各々について同じであるが、これらカットオフ回路
の各々は、異なる温度限界を有するか又は異なる限界を
有してもよい。破壊される組織の環境及びそれに隣接す
る器官における過剰な過熱を防ぐための生理学的な評価
に基づいて、患者を保護するために次のような限界が設
定されている。回路211及び212のセンサカットオフは、
センサ241及び243に対応し、カットオフとして90℃の設
定値を有する。説明上、組織のタンパク質の相ずれ（de
phasing）を与えて組織を破壊するには、60℃の温度で
充分である。センサ242で検出されるガイド16の温度
は、カットアウト回路213によってセットされ、45℃の
温度である。これは、ガイドが配置される尿道にダメー
ジが生じないように確保する。換言すれば、尿道内の物
質は、温度が45℃以下に維持される場合には破壊されな
い。カットアウト回路のいずれか１つが動作する場合に
は、オペレータの判断に係わりなく全システムが自動的
に遮断する。従って、センサ241又は243のいずれかが90
℃に達するか又はセンサ242が45℃に達する場合には、
装置が遮断する。
上記のように、典型的に直腸プローブ16に配置される
センサ37、38及び39の目的は、隣接する器官のダメージ
を防止し、特に、腸の過熱に対して保護することであ
る。好ましい実施形態におけるこの温度設定は、センサ
37、38及び39の各々に対して40℃にセットされる。40℃
とは、人体の正常の体温（37.5℃）より若干高い温度で
ある。従って、この場合も、センサ37、38及び39のいす
れかがそれらの所定のカットオフ限界を越えると、針30
6、308へ電力を付与する動作全体が遮断される。
又、図３には、繰返数調整回路245も示されており、
これは、パルス状のエネルギー出力を与えるのに使用で
き、生理学的な要件に基づいてエネルギー付与時間を変
えられるようにする。エネルギーのパルス出力付与は、
エネルギー付与間の間隔を調整してエネルギーのバース
トを与えるように電子的にパルス発生するものであり、
これは、短時間付与したときには、いずれの温度センサ
もそれらの所定値を越えるものでないが、針の付近にお
いて病巣として選択された組織体積内の細胞を殺すに充
分なエネルギーを与えるものである。このようなエネル
ギースパイクを付与した後に、次のスパイクまでの間隔
があることにより、全エネルギー付与を、隣接する組織
領域又は隣接する器官に影響を及ぼさない値にすること
ができる。換言すれば、電子的パルスの付与は、短い時
間中に局部的な破壊作用をもたせるようにエネルギース
パイクを付与する機会を与えると同時に、所定時間中の
全エネルギーを制限して、所望の病巣体積以上の組織の
塊及び他の人体器官に著しく影響しないようにする。ス
パイクは、制御された短い時間中に付与され、そして制
御された最大レベルを有していて、例えば、３分の全サ
イクル中に、全エネルギーが、連続付与中に与えられる
エネルギーと同じであるか又はそれ以下となり、このエ
ネルギーは、いずれの温度センサカットオフスイッチも
トリガーしないように計算される。
電子的パルスは、必要なとき及び所望されるときに、
非常に局部的な目標領域において細胞を効率的に破壊
し、しかも、この方法及び装置の安全性を維持する機会
を与えるものである。上記のように、付与される全エネ
ルギーは、連続動作中に付与されるものよりも大きくな
いので、センサの温度限界を越えることがない。
電子的パルスの付与の監視は、モニタ上で観察される
温度に基づいて手動で行われる。即ち、オペレータは、
温度がカットオフ限界へ近づくのを観察しそして冷却が
生じるまでエネルギーの付与を停止し、次いで、パルス
エネルギーを再付与することができる。或いは又、この
ような監視は、ある細胞領域を破壊するのに必要なエネ
ルギースパイクの付与と、その後の温度上昇及び温度上
昇率の電子的な監視とによって制御されるプリセットパ
ラメータに基づいて電子的に行うことができる。手動で
行われるか又は生理学的な要件に基づいて電子的に行わ
れるこれらの電子的パルス付勢段階は、いずれも患者の
安全性に影響を及ぼすことがない。というのは、針に隣
接する組織の塊にある温度センサ或いは尿道又はその隣
接人体器官にあるカテーテルガイドのセンサのいずれか
がそのプリセットされた安全温度を越える場合には、温
度カットオフスイッチの各々が電源全体を自動的に遮断
するように機能するからである。手動で行われるか又は
電子的な生理学的機構を介して行われる電子的なパルス
付勢は、パルス繰返数調整回路245により、周囲組織又
は隣接人体器官に悪影響を及ぼすことなく目標組織の塊
を破壊する効率を最大にする機会を与える。
本発明の方法による電力付与システムの動作は、図３
及び４を参照して説明する。図４は、操作システムの好
ましい実施形態のフロントパネルを示す。図３と図４の
関係は、図３にＡ−Ｉで示された種々の測定回路からの
出力が図４の電源のフロントパネルのディスプレイＡ−
Ｉを指すというものである。ディスプレイＡは、電源、
特に、変圧回路104によって付与されるようにオペレー
タによりセットされた電力を示す。実際の付与電力を表
す別の電力ディスプレイもある。前記したように、電源
は、100オームのインピーダンス負荷に対して校正され
ている。100オームのインピーダンスと特定の患者との
間の変動は、ディスプレイＡにセットされた電力と、実
際に付与されて回路203により測定されそしてＢに表示
される電力との間に若干の変動をもたらす。回路の完成
を検出するために、インピーダンス測定回路204は、イ
ンピーダンスの表示を装置のフロントのディスプレイパ
ネルＣに供給する。温度測定装置221−226に関連した残
りのディスプレイＤ−Ｉは、針ガイド16からのセンサ24
1−243及びプローブ18からのセンサ37−39の各々の温度
をフロントパネルに表示する。図４のフロントパネルの
適当な指示は、どのセンサが監視されるかを容易に識別
する。オペレータによる温度の監視は、カットオフ回路
211−216の動作とは完全に独立しており、これらカット
オフ回路は、既に述べたように、オペレータが行う操作
に係わりなくシステムを自動的に遮断するよう動作する
ことを強調しておかねばならない。センサの温度がカッ
トオフ限界値より下がるまではそれ以上の動作も再始動
も生じない。
好ましい実施形態において、コネクタ47及び48は、種
々のプローブに取り付けられ、接続47の１つは、針へ電
力を付与する出力を与えると共に、３つのセンサ241、2
42及び243からの各温度信号に対しセンサ接続を果た
す。個別コネクタ48は、センサ37、38及び39から送られ
る温度を受け取る。
針ガイドに関連した３つのセンサ及び直腸プローブ18
に関連した３つのセンサを説明したが、付加的なセンサ
又は異なる配置のセンサを使用すると共に、人体の他の
部位の温度から生じる生理学的な暗示を認識するように
温度カットオフ限界をセットできることも容易に明らか
であろう。
又、好ましい実施形態では、センサ37−39及び241−2
43はサーモカップルであるが、他の形式の温度センサも
意図される。
図３及び４の好ましい実施形態により付与されるRFエ
ネルギー周波数は、上記したように、482KHzの周波数で
ある。他の周波数も使用でき、その範囲は、特に、電流
路における神経系又は感覚器官に対して人体内の生理学
的変化に実質的に影響しない周波数によって決定され
る。これらの要件を用いると、周波数範囲は、信号の周
波数のみに基づくダメージを回避するために約250KHz以
上から延びる。もちろん、回避されるべき他のダメージ
は、高電圧及び大電力の付与によるものである。特に、
回避されねばならないのは、激しいダメージを生じるこ
とのある大電力サージである。このような大きな電力サ
ージは、組織の破壊によって特定のインピーダンスが著
しく変化するときに、電気メスにおいて容易に生じ得
る。このような急激なインピーダンス変化は、非常に高
い電圧を発生させ、これは、隣接する神経系の要素及び
隣接する器官の機能に甚だしいダメージを及ぼし、受け
入れられない割合の不能症を生じることがある。
本発明の電力付与方法は、インピーダンスレベルのこ
の急激な変化を回避すると共に、特に、回路のインピー
ダンスを著しく変化させることなく一定エネルギーの連
続付与に基づき電気サージを回避する。
繰返数の調整による上記パルス付勢の動作によって構
成される別の実施形態においては、相当の時間周期にわ
たり全エネルギーが実質的に一定に保たれそしてインピ
ーダンスレベルが一定に保たれるが、これとは明確に対
照的に、電気焼灼では、信頼性のあるフィードバック制
御を伴わない電気焼灼手術中にしばしば生じるインピー
ダンスのブレークダウンによって途方もなく大きなエネ
ルギーピークが発生する。
本発明の実施形態による所望の処置領域における組織
切除は、低電力の実質的に一定のエネルギーを針によっ
て正確に付与して、健康な隣接組織及び隣接する神経系
の要素及び人体器官への影響を最小にすることにより達
せられる。
BPHを処置するために、図３及び４の電力付与システ
ムを使用する処置方法は、オペレータが５ないし７ワッ
トのエネルギーレベルを３分間付与した後に、針を他の
処置領域に再配置し、そして同じ範囲のエネルギーを更
に３分間再付与することを含む。付与の回数は、切除さ
れるべき組織の程度及び位置により決定される。各操作
中に、温度カットオフ限界回路は、予期しない温度上昇
により必要な保護を与え、この温度限界は、処置されて
いる組織、尿道及び隣接する器官の付近の環境の制御を
確保する。温度上昇に対する隣接器官の保護は、センサ
37、38及び39に関連して温度カットオフ限界によって与
えられる。
上記の教示に鑑み、本発明の多数の付加的な変更及び
修正がなされ得ることが明らかである。それ故、請求の
範囲内で、本発明は、上記とは異なる仕方で実施できる
ことを理解されたい。
フロントページの続き (72)発明者 ランドキスト インゲマー エイチ アメリカ合衆国 カリフォルニア州 93953 ペブル ビーチ マイル ドラ イヴ アット ザ デューンズ 17 (72)発明者 ラックス ロナルド ジー アメリカ合衆国 カリフォルニア州 95945 グラス ヴァリー グレンブル ック エステイツ コート 10724 (72)発明者 ストラル ブルーノ アメリカ合衆国 カリフォルニア州 94303 パロ アルト バウティスタ コート 918

Claims (9)

    (57)【特許請求の範囲】
  1. 【請求項１】尿道を形成する尿道壁が内部へと延びてい
    る基部を有する膀胱および前記尿道壁を取り巻く前立腺
    を有した男性の治療を行うための装置であって、近端お
    よび遠端を有し該近端から遠端へと延長する通路を有し
    ていて、前記尿道内へと導入されうるような大きさとさ
    れた細長いプローブ部材と、該細長いプローブ部材の前
    記近端から前記遠端へと延長する前記通路に配置される
    少なくとも１つの針と、前記細長いプローブ部材の前記
    近端に取り付けられた制御取手と、該制御取手によって
    担持され且つ前記針に取り付けられ、該針の遠端を前記
    尿道壁を通して且つ前記前立腺の組織内へと進めるため
    の手段とを有しているような装置において、前記針は、
    高周波導電性電極と、該高周波電極に対して同軸的に配
    設された絶縁スリーブとを備えており、前記制御取手
    は、前記高周波電極および絶縁スリーブを前進させたり
    後退させたりする手段と、前記高周波電極へと高周波エ
    ネルギを付与するための高周波電源とを含んでおり、前
    記高周波電源は、前記前立腺の組織を切除するために十
    分な高周波エネルギが前記前立腺の組織に付与された時
    に、前記高周波電極への高周波電力の印加を停止させる
    手段を含むことを特徴とする装置。
  2. 【請求項２】前記高周波電源は、16ワットまでの高周波
    電力を付与することができる請求項１記載の装置。
  3. 【請求項３】前記高周波電力は、５−７ワットの範囲の
    電力で少なくとも３分の期間に亘って付与される請求項
    ２記載の装置。
  4. 【請求項４】前記絶縁スリーブは、遠端を有しており、
    該絶縁スリーブの前記遠端には、第１の温度感知手段が
    担持されており、前記電源は、前記第１の温度感知手段
    によって測定される温度が90℃を越える時に、前記高周
    波電極への高周波の付与を停止させるための手段を含む
    請求項１記載の装置。
  5. 【請求項５】前記細長いプローブ部材には、前記第１の
    温度感知手段に近接して配置される第２の温度感知手段
    が担持されており、前記高周波電源は、前記第２の温度
    感知手段による温度が45℃を越える時に、前記高周波電
    極への高周波電力の印加を停止させるための手段を含む
    請求項４記載の装置。
  6. 【請求項６】前記高周波電源は、温度、時間およびイン
    ピーダンスのうちから選択された少なくとも１つのパラ
    メータの電力の印加を停止させるための手段を含む請求
    項１記載の装置。
  7. 【請求項７】前記温度パラメータは、前記男性の直腸に
    配置された温度センサによって与えられる請求項６記載
    の装置。
  8. 【請求項８】前記細長いプローブ部材には、第１および
    第２の温度センサが担持されており、該第１の温度セン
    サは、前記尿道壁の一方の側で前記前立腺の組織に配置
    されており、前記第２の温度センサは、前記尿道壁の他
    方の側に配置されており、前記温度パラメータは、前記
    第１および第２の温度センサのうちのいずれかによって
    与えられる請求項６記載の装置。
  9. 【請求項９】前記高周波電力源は、実質的に一定の増分
    および減分電力レベルで前記高周波電力を付与する手段
    を含む請求項１記載の装置。
JP6525623A 1993-05-14 1994-05-13 Ｂｐｈ切除方法及び装置 Expired - Fee Related JP2647557B2 (ja)

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CA2162887C (en) 1999-08-03
KR960702277A (ko) 1996-04-27
US5843026A (en) 1998-12-01
US5865788A (en) 1999-02-02
DE69431838D1 (de) 2003-01-16
EP0697837A1 (en) 1996-02-28
AU6908794A (en) 1994-12-12
CN1128943A (zh) 1996-08-14
KR0181538B1 (ko) 1999-04-01
CA2275162C (en) 2000-11-07
US5385544A (en) 1995-01-31
EP0697837A4 (en) 1997-02-05
WO1994026178A1 (en) 1994-11-24
ATE228800T1 (de) 2002-12-15
AU680509B2 (en) 1997-07-31
US5540655A (en) 1996-07-30
DE69431838T2 (de) 2003-10-09
JPH08508664A (ja) 1996-09-17
CA2162887A1 (en) 1994-11-24
EP0697837B1 (en) 2002-12-04

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