JP4559860B2 - 温熱療法の実施により腫瘍の成長を防止するシステム - Google Patents
温熱療法の実施により腫瘍の成長を防止するシステム Download PDFInfo
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Description
前立腺癌を治療するための、現在の標準的な医療には、前立腺全体を手術により除去する根治的または神経温存的前立腺摘除術や、前立腺カプセルを貫通、または貫通する可能性がある微視的な癌細胞を捕らえる外部ビーム放射療法と組み合わせて、6〜9ヵ月にわたり放射が有効な少量の放射線シードを前立腺に永続的に埋め込む、または多量の放射線シードを一時的に約2日間にわたり前立腺に埋め込む近接照射療法が含まれる。手術の副作用には、失禁やインポテンスが挙げられる。手術後の癌の再発率は、特に前立腺特異抗原レベル(後述)が10を超える場合に、5年目で約35%、10年目で約60%と非常に高い。放射線療法は、皮膚反応、疲労および嘔気などの短期の副作用をもたらす。前立腺への放射線療法のさらなる長期の副作用として、尿失禁(膀胱コントロールの喪失)およびインポテンス、ならびに周辺器官への損傷などが挙げられる。
良性前立腺肥大(BPH:Benign Prostatic Hyperplasia)は、主に、尿道に圧迫を加える前立腺の拡大として説明されており、結果として尿の流れを妨げる、中高年の男性に多い悩みである。65歳以上の男性の約50%が、BPH症状を持ち、これは、彼らの生活の質に多大な影響を及ぼしている。米国泌尿器科学会(AUA:American Urological Association)症状指標(Symptom Index)は、BPH症状の分類を助けるために開発された。AUAスコアは、次のスコア範囲を有している。0〜7ポイントでは、BPH症状は軽いとみなされる。8〜19ポイントでは、BPH症状は中程度とみなされる。20〜35ポイントでは、BPH症状は深刻とみなされる。しかしながら、多くのBPH患者は、AUAスコアが約12になるまで治療を求めない。
BPH治療の“最良の選択(Gold Standard)”)は、電子手術ループを有する硬質の経尿道スコープを用いて肥大した前立腺組織の一部(主に、前立腺の中央領域)を、RFエネルギーにより除去する手術処置を含む。実際には、BPHのための手術処置の90%は、TURPを含んでおり、これは、90%の患者に対するその良好な効果性(85%以上)、長い持続性(10〜15年)による。一年間におよそ200,000回のTURPが、米国で行われている。TURPは、多くの欠点を有する。これは、非常に大きな苦痛を伴う処置であり、2〜4日の入院および2〜4週間の自宅療養の両方を必要とする。TURP処置は、約1時間で行われ、全身麻酔を必要とする。処置は、泌尿器科医が行わなければならない。治療後は約2〜3日の間、フォーリーカテーテルが必要となる。TURPの主要な潜在的副作用には、インポテンス、失禁、大量失血、および逆行性射精が含まれる。
開放性前立腺摘除術は、非常に大きな前立腺を有する患者に主に用いられ、良好な結果をもたらしている。効果性は95%を超え、持続性はTURPと同等(10〜15年)である。どのような手術処置によっても、苦痛レベルは非常に高く、全身麻酔が必要である。約7〜10日の入院と、追加の3〜5週間の自宅療養が必要である。処置は数時間を要し、泌尿器科医によって行われなければならない。治療後に、膀胱からの排水を行うために、2〜4日の間フォーリーカテーテルを使用する必要がある。開放性前立腺摘除術は、TURPのほぼ2倍の費用を要し、大量失血、インポテンス、および失禁などを含む深刻な潜在的副作用および併発症を有する。
基本的には、TURPの改良である、前立腺の経尿道的電気蒸散術は、溝のある電子手術ローラーボール電極を用いて、前立腺組織により塞がれていた尿道のチャンネルを開く。TVP処置は、より安全であり、TURPと比べて最小の副作用をもたらす。効果性は良好(85%)であるが、これも非常に苦痛を伴う処置であり、2〜4日の入院と、1〜2週間の自宅療養を必要とする。泌尿器科医がこの60分の処置を施し、患者は全身麻酔にかけられる。この処置の後、フォーリーカテーテルを、2〜4日間使用しなければならない。この処置は、TURPよりは、いくらか低い費用を要する。TURPよりも、少ない失血を伴うが、やはりインポテンス、失禁、および逆行性射精などの潜在的副作用がある。
前立腺の小さな患者向けの、比較的新しい処置である、前立腺の経尿道的切開術は、約80%の効果性を提供する。しかしながら、TUIPは、大きな前立腺には効果的でない。この処置では、最小量の前立腺組織を除去する。前立腺の全長に沿って簡素な切開を行う。TUIP処置は、膀胱頸部の開口を可能にし、尿の流れを自由にする。持続性は、TURPと同様であると見込まれるが、臨床研究は現在も進行中である。この処置は、中程度の苦痛を伴い、1〜2日のみの入院を必要とし、あるいは数人の患者に対しては、外来処置となる。処置後は通常、4〜7日の自宅療養が必要である。泌尿器科医が、この60分の手術処置を行わなければならず、フォーリーカテーテルを、2〜4日間使用しなければならない。TUIPの費用は、TURPとほぼ同じである。この処置では、TURPと比べてより少ない失血を伴うが、ここでもまだ、インポテンス、失禁、および逆行性射精などの潜在的副作用がある。
前立腺の小さな患者に対し、尿道前立腺部内での風船膨張を用いて、BPH症状のいくらかの軽減を提供することができる。効果性は、約60%しかなく、持続性は1〜5年のみである。この処置は、TURPよりも低い費用を要し、通常は、数日の自宅療養を要する外来処置として行われる。処置は、局部麻酔のもと、泌尿器科医により、約30分で行われる。フォーリーカテーテルを、約2〜4日間必要とする。この処置では、いくらかの出血の可能性があり、感染およびインポテンスなどの潜在的副作用がある。この処置は、大きな前立腺には上手くいかない。
小さな前立腺を持つ極めて重篤の患者向に対し、ステントを用いて、良好な効果でBPH症状の改善をもたらすことができる。これらの患者は通常、他の病気で重篤であるため、持続性は大きな問題とならない。この処置は、中程度の苦痛を伴い、局部麻酔のみを必要とし、泌尿器科医により約30分の間で行われ、約4〜5日の自宅療養を要する外来処置として行われる。この処置の費用は、TURPよりもいくぶん低い。潜在的副作用に、炎症、感染、およびステントへの破片蓄積がある。
2種類の薬物が、BPHの治療に用いられる。1つの種類は、アルファ遮断剤(ハイトリン(Hytrin)またはカルデュラ(Cardura))を使用し、前立腺を囲む筋肉を弛緩させ、尿流量を向上させる。他の種類の薬物は、レダクターゼ抑制剤(プロスカー(Proscar))で、これは前立腺を実際に収縮させる。
ここで、介在製レーザー凝固手術装置は、レーザーエネルギーを、注文設計された光拡散器の長さに沿って放射状に放出するものである。拡散器は、熱ダメージの楕円パターンを生成し、レーザーエネルギーを前方向かつ均一に印加し、前立腺内の治療組織量を最大化する。これは、中程度の苦痛を伴う手術処置であり、1〜2日の入院に次いで1〜2週間の自宅療養を必要とする。この30分の処置は、泌尿器科医により行われる必要があり、患者の状態に応じて、全身または局部麻酔のいずれかが選択される。この処置の深刻な欠点は、フォーリーカテーテルを使用して膀胱の尿を排出させる期間が、1〜2週間と長いことである。この処置の費用は、TURPより低い。この治療では、インポテンス、失禁、失血、および逆行性射精を含む多くの潜在的副作用がある。
このシステムは、2つの高エネルギーRF(約0.47MHz)針を使用し、これらは、尿道を介して前立腺に挿入され、前立腺組織を数分間で切除する。世界中で10,000人を超える患者が、このシステムにより治療されている。このシステムは、良〜最良の効果性を提供する。このシステムには、12ヵ月の限定された持続性データしかなく、長期の効果については知られていない。この処置は、中程度の苦痛を伴い(局部麻酔を要する)外来処置として行われ、1〜2週間の自宅療養を要する。処置は、通常、泌尿器科医により、約30分で行われる。患者の約40%が、約2〜3日間にわたりフォーリーカテーテルを必要とする。この処置の費用は、TURPよりも低い。この処置の大きな副作用として、排尿時の痛み、勃起障害、および逆行性射精などがある。
2.存在し得るBPH症状の即座の軽減
3.長い持続性
4.経験される苦痛が低レベルであること
5.外来処置
6.局部麻酔
7.フォーリーカテーテルが不要であること
8.大きな副作用または合併症がないこと
1999年に、譲受人セルシオンコーポレーション(Celsion Corporation)により行われた臨床試験で証明されたように、圧縮風船の膨張とマイクロ波熱(マイクロ波尿道形成術)の組み合わせにより、生物学的なステントを、尿道前立腺部に形成することができる。その結果、既知のBPH治療における大きな欠陥の1つ、すなわち数日間必要なフォーリーカテーテルが、もはや必要ではなくなり、患者は、BPH症状の即座の軽減を経験することができる。
前立腺220は、男性生殖系の一部であり、膀胱202のすぐ下および直腸210の前で尿道205の第1部分を囲む、固体でクルミ形の器官である。前立腺癌は、前立腺から発生し、前立腺癌の最も一般的な形態は、腺癌として知られており、これは、腺の癌という意味である。ほとんどの前立腺癌は、前立腺の直腸に最も近い底部(時に、周辺領域と呼ばれ、これは前立腺の約70%を含む)から成長し、これは、大きな治療を必要とする領域である。直腸触診は、前立腺内の硬化部分またはかたまりの検出に有用であるが、微視的な前立腺疾患の検出には有用ではない。前立腺のこの部分への到達に、経直腸アプリケータを使用することが、前立腺の完全な治療のために重要である。前立腺の中央領域(膀胱に最も近い)は、BPHおよび前立腺癌疾患の両方に対し、比較的免疫性がある。BPHは、主に中央領域と周辺領域の間に位置する移行領域において発生する。
図1は、好ましくはマイクロ波である適応性エネルギーフェイズドアレイ温熱療法システムを、電界および温度フィードバックと共に用いた、前立腺組織の癌腫および良性腫瘍細胞を加熱するための好適なシステムを示している。エネルギー周波数において深部組織を確実に加熱するために、身体(前立腺葉220)を、適応性フェイズドアレイアルゴリズムで制御された2つ以上のエネルギーアプリケータ110,111(それぞれ尿道205および直腸210内にある)によって囲む必要がある。エネルギーアプリケータ110,111は、コヒーレントなマイクロ波アプリケータであってもよい。焦点190として示される黒い円は、治療される前立腺220の中央の腫瘍または健康な組織を表わしている。
前立腺癌および良性前立腺肥大の温熱治療においては、尿道および直腸の温度を低く保ちながら、前立腺内の治療温度を得ることが望ましい。前立腺にマイクロ波エネルギーを照射する間に、尿道および直腸における周辺組織が加熱される傾向があるため、周囲の健康な組織を保護しながら安全に前立腺を加熱するための方法を、開発する必要がある。
温熱療法アプリケータからのマイクロ波エネルギーは、身体の近距離場において、電界振幅が部分的にアプリケータからの放射距離rの逆として変化しながら、球面波として放射される。その上、身体組織の減衰定数αと、図1に示される身体内を横切る距離(または深さ)dとの積の指数関数として、振幅が減衰する。電界フェイズが、フェイズ伝播定数βと距離dとの積に従う距離により直線に変化する。簡潔さのために、二重対向アプリケータを、アプリケータ放射が平面波に近似するという過程のもとに分析する。数学的に、組織内の深さに対する平面波電界は、E(d)=E0exp(−αd)exp(−iβd)により得られ、ただし、E0は表面電界であり(一般に、振幅およびフェイズ角として表わされる)、iは虚数である(フィールド(Field)およびハンド(Hand)、臨床温熱療法の実践的側面の概論(An Introduction to the Practical Aspects of Clinical Hyperthermia)、テイラー&フランシス(Taylor & Francis)、ニューヨーク(New York)、263頁、1990年)。
電気エネルギー消費は、一般にキロワット時間の単位で表現される。数学的に、アプリケータにより供給されるマイクロ波エネルギーWの表現は、次の式により得られる(ビトロガン(Vitrogan)、電気および磁気回路の素子(Elements of Electric and Magnetic Circuits)、ラインハート出版(Rinehart Press)、サンフランシスコ(San Francisco)、31〜34頁、1971年)。
上の式において、Δtは、一定間隔を(秒で)表わし、この間隔において、無線周波数電力が測定され、合計Σは、第i間隔における電力(ワット)をPiで表わした、全治療間隔にわたるものである。
等価熱量の計算
摂氏43度に比例する、累積すなわち合計の等価熱量を、次のように合計として計算する(サパレト(Sapareto)ら、放射線腫瘍生物物理学の国際ジャーナル(International Journal of Radiation Oncology Biology Physics)Vol.10,787〜800頁、1984年)。
ただし、Σは治療の間の一連の温度測定の合計であり、Tは一連の温度測定(T1,T2,T3,...)であり、Δtは、測定の間の一定の時間間隔(秒の単位で、分に変換)であり、Rは、T>43℃の場合に0.5に等しく、Rは、T<43℃の場合に0.25に等しい。等価な熱量計算は、前立腺組織、尿道および直腸への、発生し得る熱ダメージを推定するのに有用である。
本発明を、特に、好適な実施形態を参照して図示し、説明してきたが、当該分野の当業者には、形態および詳細のさまざまな変更を、添付の特許請求の範囲に定義される本発明の要旨および範囲から逸脱することなく、行うことが可能であることが理解されるであろう。例えば、本明細書に記載される温熱療法システムは、前立腺癌および良性前立腺病変の治療に関するものであるが、本発明は、胸部、肝臓、肺および卵巣などの他の種類の癌の治療にも適用可能である。開示される好適な実施形態に加えて、本明細書に記載される方法は、風船カフ(例えば血圧カフ)または他の器具により圧迫可能な脚および腕ならびに胴などの、人体の他の付属器官および位置のマイクロ波、無線周波数、または超音波温熱治療に適用できるものと理解される。また、同様の結果をもたらすより多いまたは少ない数のアレイアンテナアプリケータ、またはインプラントなどの単一のアンテナアプリケータ、あるいは経尿道または経直腸アプリケータを使用できるものと理解される。本明細書に記載される方法および技術のいくつかは、また、超音波温熱療法システム、特にフィードバック制御のためのエネルギー量の使用に適用可能である。本発明に係るシステムは、放射線療法の拡張のために、または感熱リポソームを用いた標的薬物供給、および/または標的遺伝子供給、あるいは標的遺伝子療法に使用することができる。本発明は、工業加熱に用いられるような、非医療用の温熱システムにも適用可能である。
Claims (6)
- 温熱療法を安全に施すためのシステムであって、
治療される器官および付属器官のうち少なくとも1つを圧迫して当該器官または付属器官の血流を減少させる風船カテーテルおよび風船カフのうちの1つと、
癌性および/または良性の器官および/または付属器官の治療のために、化学療法剤、遺伝子療法剤、化学療法剤を含む感熱リポソーム、および放射線療法剤のうちの1つを前記圧迫と組み合わせて与えながら、前記器官および付属器官のうち少なくとも1つにエネルギーを与えるための少なくとも1つのエネルギーアプリケータと、
化学療法剤、遺伝子療法剤、化学療法剤を含む感熱リポソーム、および放射線療法剤のうちの1つを患者の血流に注入して治療剤を供給した後に風船カテーテルを膨張および収縮する手段であって、その膨張および収縮する手段は、前記風船カテーテルを膨張させて第1の期間の間、前記器官を圧迫し、前記第1の期間の後には、前記器官の温度を下げることなしに第2の期間の間、前記風船カテーテルを収縮させて前記器官に自由に血流が流れるようにし、前記第2の期間の後には、第3の期間の間、前記器官を圧迫して血流を減少させることにより前記器官内に治療剤を閉じこめることと
を備えるシステム。 - 前記風船カテーテルは、経尿道風船カテーテルおよび経直腸風船カテーテルのうち少なくとも1つである、請求項1に記載のシステム。
- 治療される前記器官は前立腺であり、前立腺を圧迫するのに風船カテーテルが用いられ、前記経直腸風船カテーテルおよび/または経尿道風船カテーテルの膨張の結果としての前立腺圧迫の量を調整および確認する手段をさらに備える、請求項2に記載のシステム。
- 前記調整および確認する手段は、ドップラー超音波撮影システムからのリアルタイムフィードバックを用いて前立腺圧迫の量を調整および確認する、請求項3に記載のシステム。
- 前記膨張および収縮する手段は、所望の量の治療剤が前記器官に供給されるまで前記風船カテーテルの膨張および収縮を繰り返す、請求項1に記載のシステム。
- 前記付属器官は、腕、脚または胴のうちの1つである、請求項1に記載のシステム。
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