JP4450622B2 - インピーダンス制御組織剥離装置および方法 - Google Patents
インピーダンス制御組織剥離装置および方法 Download PDFInfo
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Description
本発明は、一般的に、侵襲性が最小である方法を使用して組織を処置するための方法に関する。より詳細には、本発明は、腫瘍組織および疾患組織を剥離処置するための装置および方法に関する。なおより具体的には、本発明は、インピーダンス値を使用して、標的組織部位への電磁的剥離エネルギーの送達を制御および最適化する、腫瘍組織を剥離処置するための装置および方法に関する。
種々の剥離療法(例えば、無線周波数剥離、マイクロ波剥離およびレーザー剥離)が、良性腫瘍および癌性腫瘍を処置するために使用され得る。理論において、このような方法は、選択された標的組織の細胞壊死または細胞破壊を引き起こすために、生理学的変化および構造変化を生成することが意図される。しかし、実際に、癌組織を処置するための剥離手順の使用において、多くの問題点が存在し、これらとしては、以下が挙げられる:(i)標的組織の位置を突き止めること、(ii)腫瘍組織の疾患状態の同定または生検の実施、(iii)疾患組織と健常組織とを区別すること、(iii)標的組織部位内に剥離器具の位置を配置しその位置を維持すること、(iv)拡大中の剥離体積を含む剥離の進行をモニタリングすること、(v)隣接する臨界構造に対する損傷を最小化すること、(vi)健常組織の十分な余地の補償を含む腫瘍塊の完全な剥離の達成、および(vii)完全な剥離の程度の評価。現在の剥離治療は、これらの問題に対する解答を考慮も提供もしてこなかった。従って、これらの問題点に対処する装置および方法に対する必要性、ならびに癌、腫瘍および他の疾患の処置に対する剥離治療を実施することにおけるまだ検討されていない必要性が存在する。
本発明の実施形態は、インピーダンス制御組織剥離装置および方法を提供し、これらはインピーダンス測定法(例えば、標的組織部位への無線周波数または他の電磁的エネルギーの送達を最適化し、より低い出力レベルおよびより速い剥離時間を使用して、従来のRF組織剥離技術を用いた現在可能なものより大きな剥離体積を作製するような、局所的組織インピーダンス)を使用する。剥離体積を作製するために必要とされる出力レベルを低下することによって、本装置はまた、パッド火傷および従来のRF剥離療法に付随する他の電気ショックの事故の危険性を有意に減少する利益を提供する。本発明の関連する実施形態は、組織部位で電解質流体の制御された輸液を使用して、剥離エネルギーの送達が最適なレベルで、組織インピーダンスを制御および維持する。
(定義)
以下の用語は、本明細書中で使用される場合、別段指摘されない限り、以下の意味を有する:
「電極」、「弾性部材(resilient member)」および「アンテナ(antenna)」は、交換可能であり、そして、これらは、組織部位にエネルギーを導電させるための針(ニードル)またはワイヤをいう。電極は、受動性であるか、能動性であるか、または受動性もしくは能動性の間で切り換え可能(スイッチ可能)である。さらに、電極は、患者の外部位置において位置付けられ得る接地(ground)パッド電極であり得る。
(i)インピーダンス決定システム全体(身体を通る導電経路、接地パッド電極および付随するワイヤ)のインピーダンスに関連し、そして/またはこのインピーダンスによって遮蔽されて、信号が非常に小さい:
(ii)測定が、所望の組織部位から非常に遠く離れた身体上でなされ、従ってまた、遮蔽される;および
(iii)局所的なインピーダンスが、組織に送達されるRFまたは他の剥離エネルギー信号によって遮蔽された。
本発明の実施形態は、これらの問題に対する解決法を提供し、局所的なインピーダンス変化(特に、剥離手順の間に生じる変化)を、標的組織に位置するインピーダンスアレイの使用によって検出し、複素インピーダンスを含むインピーダンスおよび本明細書中に記載される他の生体電気化学的特性を決定する。
(i)信号分解能および予測される組織状態の統計的信頼度を増強させる、選択したサンプル体積を通して、経路数を変化させる;
(ii)2つ以上の導電性経路間の角度を変える;そして
(iii)サンプル体積の大きさを変える;(iv)第1サンプル体積と第2のサンプル体積との間で切換え;そして(v)同時に2つの体積またはサンプル体積を比較する。
(i)特有のインピーダンスプロファイルのデータベースを含むメモリーリソース;
(ii)組織の型および/または状態のインピーダンスベースの診断のための出力ウィンドウ;
(iii)発生装置が新たに得たインピーダンス走査から学習可能な人工知能のアルゴリズム/プログラム;
(iv)ユーザが発生装置に生検または病理学に基づいて正しい組織の型および状態を入力し、教える能力;
(v)速度、正確さを改善し、障害の影響を減少させるために同時に複数の頻度のインピーダンス感知する能力;
(vi)複雑なインピーダンスの測定および非浸潤性での標的組織評価の実施のための(電気生理学的パッドのような)非浸潤性パッドを使用する能力;
(vii)インピーダンス読み取り情報およびユーザのためのさらなる情報のベースライン比較のための参照信号およびまたは基本的な患者の電気生理学的状態をモニタリングする能力;および
(viii)デジタルサブトラクション、デジタルサプレッションおよび当該分野に公知の他の信号処理方法を用いて信号のノイズ比、信号感度または信号分析を改善する、履歴現象、信号ノイズ、参照信号または混信および他の信号障害の原因である信号を利用するためのプログラミング。
(i)導入器12からの弾性部材18の進行の量;
(ii)導入器12からの弾性部材18の独立した進行;
(iii)電極18および18’のエネルギー送達表面の長さおよび/またはサイズ;
(iv)電極18に使用される物質のバリエーション;
(v)電極18のバネ負荷または形状記憶の量の選択;
(vi)展開状態での電極18の幾何的構成のバリエーション;ならびに
(vii)弾性部材18が導入器12から進められる場合の曲率を推定するように予め形成されること。
(i)約915MHz〜約2.45GHzの周波数範囲でマイクロ波エネルギーを提供する、マイクロ波アンテナに連結されたマイクロ波電源;
(ii)無線周波数(RF)電極に連結されたRF電源;
(iii)光ファイバーまたはライトパイプに連結されたコヒーレント光源;
(iv)光ファイバーに連結された非コヒーレント光源;
(v)加熱流体を受容するように構成された閉鎖管腔または少なくとも部分的に解放された管腔を有するカテーテルに連結された、加熱流体;
(vi)冷却流体を受容するように構成された閉鎖管腔または少なくとも部分的に解放された管腔を有するカテーテルに連結された、冷却流体;
(vii)低温流体;
(viii)導電性ワイヤに連結された抵抗加熱源;
(ix)超音波放射器に連結された超音波電源(ここで、この超音波電源は、約300KHz〜約3GHzの範囲の超音波エネルギーを発生させる)、(xi)ならびにこれらの組み合わせ。この適用の残りについての議論を容易にするため、エネルギー送達デバイス18eは、1つ以上のRF電極18であり、そして利用される電源は、RF電源である。これらおよび関連の実施形態について、RF電源20は、5〜200ワット、好ましくは5〜100ワット、そしてなおより好ましくは5〜50ワットの電磁エネルギーを、妨害なしにエネルギー送達デバイス18eの電極に送達するように構成され得る。これらの電極18は、エネルギー源20に電磁的に連結されている。この連結は、エネルギー源20から各電極18へと、それぞれ直接的であり得るか、または1つ以上の電極をエネルギー源20に連結するコレット、スリーブなどを使用することによって間接的であり得る。
本出願人は、組織のインピーダンス測定を含む最小の侵襲性の方法を使用する腫瘍の診断および処置のための新規の有用な装置および方法を提供したことが理解される。本発明の種々の実施形態の上記の説明は、例示および説明のために示されている。これは、網羅的であることも本発明を開示される詳細な形態に限定することも意図しない。本発明の実施形態は、多数の器官(肝臓、***、骨および肺が挙げられるが、これらに限定されない)の組織表面におけるまたはその下の腫瘍および組織塊の処置のために構成され得る。しかし、本発明の実施形態は、他の器官および組織にも同様に適用可能である。明らかに、多くの改変および変更が、当業者に明らかである。さらに、1つの実施形態からの要素は、1つ以上の他の実施形態からの要素と容易に組合せされ得る。このような組合せは、本発明の範囲内の多数の実施形態をなし得る。本発明の範囲は、上記の特許請求の範囲およびそれらの等価物により規定されることが意図される。
Claims (22)
- 標的組織を剥離する際に使用するための、細胞壊死装置であって、作動可能な条件で、以下:
管腔を備える細長送達デバイス;
複数の電極を備えるエネルギー送達デバイスであって、各電極は、組織穿孔遠位部分を有し、そして小型化状態で該細長送達デバイス中に配置可能であり、そして展開されると湾曲した形状を呈するように予め形成されており、該複数の電極は、該細長送達デバイスから選択された組織部位へと前進される場合に、変化する移動方向を示し、そして該展開状態にある場合に、剥離体積を規定し、該エネルギー送達デバイスは、エネルギー供給源に作動可能に接続され、該複数の電極のうちの少なくとも2つが、該複数の電極のうちの少なくとも2つを通しての、該電極に配置された少なくとも1つの導入ポートへの流体送達のために適合されており、ここで、該複数の電極のうちの少なくとも2つが、それぞれ、流体を送達するための別個の導入管腔を備える、エネルギー送達デバイス;
該複数の電極のうちの少なくとも2つの導入管腔に作動可能に接続された流体送達デバイスであって、該流体送達デバイスを通して、該少なくとも1つの導入ポートへ、該標的組織内へと流体を送達するための、流体送達デバイス;
エネルギー制御ユニットであって、(I)該エネルギー送達デバイスへのエネルギー送達を制御するために、エネルギー供給源に作動可能に接続され、そして(ii)インピーダンスを検出する際に使用するために、該エネルギー送達デバイスに作動可能に接続されている、エネルギー制御ユニット;ならびに
該流体送達デバイスのための流体制御装置であって、該流体制御装置によって、該デバイスから該標的組織内へと導入される流体の量が、該検出されたインピーダンスに応答して制御され得、ここで、該流体制御装置が、該別個の導入管腔を通る導入の独立した制御を提供するように作動可能である、流体制御装置、
を備える、
装置。 - 前記エネルギー制御ユニットが、組織インピーダンスを決定するために、前記複数の電極のうちの少なくとも1つに作動可能に接続されている、請求項1に記載の装置。
- 前記複数の電極のうちの少なくとも1つにおける、1つ以上の部位の間の導電経路に沿って、前記インピーダンスを決定することによって、局所的なインピーダンスが直接決定される、請求項1または2に記載の装置。
- 前記1つ以上の部位が、一定距離にわたる局所的なインピーダンスを決定するための、同じ電極上の少なくとも2つの部位である、請求項3に記載の装置。
- 前記複数の電極のうちの少なくとも1つが、受動電極であり、そして前記エネルギー制御ユニットが、該受動電極に作動可能に接続されている、請求項1〜4のいずれか1項に記載の装置。
- 前記複数の電極のうちの少なくとも1つに配置されており、そして前記エネルギー制御ユニットに作動可能に接続されている、温度センサをさらに備える、請求項1〜5のいずれか1項に記載の装置。
- 前記流体送達デバイスから導入される流体の量を、前記検出されたインピーダンスに応答して調節するために、前記エネルギー制御ユニットが、該流体送達デバイスに作動可能に接続されている、請求項1〜6のいずれか1項に記載の装置。
- 前記検出されたインピーダンスに応答して、前記少なくとも1つの電極に送達されるエネルギーの量を調節するために、前記エネルギー制御ユニットが手動で調節可能である、請求項1〜7のいずれか1項に記載の装置。
- 前記検出されたインピーダンスに応答して、前記流体送達デバイスから導入される流体の量を調節するために、前記エネルギー制御ユニットが手動で調節可能である、請求項1〜8のいずれか1項に記載の装置。
- 前記細長送達デバイスが、該細長送達デバイスを通しての、少なくとも1つの導入ポートへの流体送達のために適合されている、請求項1〜9のいずれか1項に記載の装置。
- 前記細長送達デバイスが、該細長送達デバイスを通しての、前記少なくとも1つの導入ポートへの流体送達のために、前記流体送達デバイスに作動可能に接続されている、請求項10に記載の装置。
- 前記エネルギー供給源が、RFエネルギー供給源である、請求項1〜11のいずれか1項に記載の装置。
- 患者における標的組織を剥離する際に使用するためのエネルギー送達デバイスであって、該エネルギー送達デバイスは、以下:
(a)管腔を備える細長送達デバイス、
(b)組織穿孔遠位端を備える複数の電極であって、該電極は、小型化状態で該細長送達デバイス内に配置可能であり、そして展開されると湾曲した形状を呈するように予め形成されており、該複数の電極は、該導入器から選択された標的組織へと前進される場合に、変化する移動方向を示し、該複数の電極のうちの少なくとも1つは、該少なくとも1つを通しての少なくとも1つの導入ポートへの流体送達に適合されている、電極、
(c)該複数の電極に作動可能に接続された、流体送達デバイスであって、該流体送達デバイスを通して該少なくとも1つの導入ポートへと流体を送達するための、流体送達デバイス、
(d)インピーダンスを検出する際に使用するための、該複数の電極のうちの少なくとも1つに作動可能に接続された、エネルギー制御ユニット、および
(e)該流体送達デバイスのための流体制御装置、
を備え、
該デバイスは、該細長送達デバイスの遠位端を標的組織内に、または該標的組織に隣接して配置するために効果的な様式で配置されることを特徴とし、
該デバイスは、
(1)該電極が、該標的組織の少なくとも一部を含む剥離体積を規定するように展開され、該電極を通して該規定された剥離体積内へと流体が導入されること;
(2)該電極に剥離エネルギーが印加され、該印加によって、該規定された体積内に含まれる標的組織が剥離され、インピーダンスが決定されること;ならびに
(3)該エネルギー送達デバイスから導入される流体の量を制御することによって、該インピーダンスが調節されること;
を特徴とする、デバイス。 - 前記インピーダンスが、前記複数の電極の異なる電極における流体量を変化させることにより調節されることを特徴とする、請求項13に記載のデバイス。
- 前記導入される流体が、導入される電解質溶液であり、そして前記デバイスが、該導入される電解質溶液中の電解質の濃度を制御することによって、該導入される溶液の導電率を変化させることを特徴とする、請求項13〜14のいずれか1項に記載のデバイス。
- 前記導入される電解質溶液が、生理食塩水溶液であり、そして該導入される電解質溶液の導電率が、該溶液の塩分を変化させることによって制御されることを特徴とする、請求項15に記載のデバイス。
- 前記流体が、前記複数の電極の個々の電極の周りの導入のゾーンを制御するように導入されることを特徴とする、請求項15または16に記載のデバイス。
- 前記インピーダンスが、全身インピーダンスまたは局所的インピーダンスであり、該全身インピーダンスについては、1つ以上の電極と、前記患者の外側との間のインピーダンスから決定され、そして該局所的インピーダンスについては、電極間または同じ電極上の2つ以上の部位間のインピーダンスから決定されることを特徴とする、請求項13〜17のいずれか1項に記載のデバイス。
- 全身インピーダンスおよび/または局所的インピーダンスを最適値に制御することによって、電力散逸効率が最大にされることをさらに特徴とする、請求項18に記載のデバイス。
- 前記インピーダンスが、最小値と最大値との間でインピーダンスを制御することによって調節されることを特徴とする、請求項18に記載のデバイス。
- 前記流体が、時間変動性インピーダンスプロフィールを生じるために、予めプログラムされた流速プロフィールで導入されることを特徴とする、請求項18に記載のデバイス。
- 前記インピーダンスの決定が、前記エネルギー供給源と同じ周波数、該エネルギー供給源とは異なる周波数、およびある範囲の周波数からなる群より選択される周波数で実施されることを特徴とする、請求項13〜21のいずれか1項に記載のデバイス。
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2002
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- 2008-01-30 US US12/022,708 patent/US20080287944A1/en not_active Abandoned
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AU2002327779B2 (en) | 2008-06-26 |
ATE320767T1 (de) | 2006-04-15 |
AU2008224345A1 (en) | 2008-10-16 |
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AU2008224345B2 (en) | 2011-11-17 |
US20030130711A1 (en) | 2003-07-10 |
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