JP5320065B2 - 吸引式凝固プローブ - Google Patents
吸引式凝固プローブ Download PDFInfo
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- JP5320065B2 JP5320065B2 JP2008526924A JP2008526924A JP5320065B2 JP 5320065 B2 JP5320065 B2 JP 5320065B2 JP 2008526924 A JP2008526924 A JP 2008526924A JP 2008526924 A JP2008526924 A JP 2008526924A JP 5320065 B2 JP5320065 B2 JP 5320065B2
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Description
本願は、同時係属の米国特許出願第11/208,456号(「Vacuum Coagulation Probes」、2005年8月18日出願)の部分継続出願であり、該出願は、その全体が参照により本明細書に引用される。
本発明の態様は、侵襲性の低い心房細動の治療のための装置と方法を目的とする。切除および/または凝固のための対象の凝固プローブは、凝固機構と吸引を一体化させ、凝固機構と軟部組織の間で直接的に、一定かつ密接な組織接触を確実にする。
この構成の観点では、本発明の多くの例示的なバリエーションが、主に、低侵襲アプローチ(例えば、胸腔鏡下、関節鏡下、腹腔鏡下、経皮的、またはその他の低侵襲アプローチ)を用いて行われる、軟部組織凝固の関連において開示される。本願で開示される一体型吸引凝固プローブのバリエーションは、軟部組織が成長できず、また電気的インパルスを伝播できず、変化できず、あるいは再生できないようにする、不可逆的な損傷が達成されるまで軟部組織を加熱しうるエネルギ(例えば、高周波または超音波)を伝達するために使用される電極または振動素子と、軟部組織表面との間の特に密接な接触をもたらす。
図1Aは、プローブ2とハンドル102からなる凝固装置のバリエーションを図示する(ハンドル本体の断面図を示す)。このバリエーションでは、プローブ2はシャフト4の遠位区画5に筐体9を有するシャフト4を含む。凝固装置のバリエーションでは、ハンドルにありとあらゆる形状や大きさが用いられてもよい。図示した例では、ハンドル102は、電源60、液体源55、吸引源50のそれぞれに接続するための複数のコネクタ21、22、23を含む。
確実に治療用の病変セットを作成するために、心臓の表面(心外膜または心内膜)に沿った所望の場所に吸引一体型凝固プローブを設置する上で遠隔アクセスは重要なことがある。図8A〜8Cは、上述のステアリング機構またはかん流チャネルを通って挿入されるスタイレットを必要とせずに、所定の経路に沿って吸引一体型凝固プローブのバリエーションを誘導するレール機構62の等角図、側面図、端面図を示す。そのようにして、吸引一体型凝固プローブの柔軟性を保つことができ、レール機構62はプローブに必要な全てのアクセスに対応できる。図8A〜8Cに示すように、個々のレール部品64は、個々のレール部品64の互いに対する三次元での回転を可能にする、連続するボール66とソケット継手によって互いに対して旋回する。ボール66とソケット継手は、内部に柔軟なロッドを備えることができる中心内腔82を含む。レール部品64の個々のボール機構66を嵌合ソケットとさらにはめ込み、レール部品を柔軟なロッドに沿って堅く締めるために、ナットを使用するときに、レール機構が操作された形にレール機構を形状に固定するために、レール機構62のハンドル端(図示せず)に含まれるナットを柔軟なロッドと連結し、堅く締めることができる。種々の三次元形状へとレール機構を操作するために、二つの引きワイヤを互いに対して、また柔軟なロッドに対して作動させることによってレール部品を操作する(例えば、操縦する)のを補助するために、個々のレール部品の水平チャネル68に沿って二つの引きワイヤが挿入される。レール機構62の位置を合わせるために引きワイヤを使用した後は、所望の形状を維持するためレール部品64は柔軟なロッドに沿って堅く締められる。レール機構62の位置を合わせて固定した後は、図9A〜9Dに示すように、吸引一体型凝固プローブ2をレール機構62のレール内腔84に沿って進展させることができる。
本発明の吸引一体型凝固プローブを用いて心房細動を治療する手法が説明される。一つの方法では、肋間腔、開胸術、胸郭開口部術、胸骨正中切開術、胸骨小切開、剣状突起下アクセスポート、側方下胸部アクセス部位、またはその他の低侵襲の外科手術で施される、切開、トロカール、またはその他のアクセス用開口部を介してプローブが胸腔に挿入される。そのようにして、制限されたアクセスの応用に付き物である、小腔を介しての進展を容易にするために、プローブの遠位区画とシャフトは小さな外形を有する。
対象装置の応用に対する柔軟性を鑑みると、本発明の吸引凝固プローブのバリエーションを用いて、任意のパターンの曲線をなす、貫壁性病変のパターンが心外膜面または心内膜面に沿って作成され得る。一つの左心房病変パターンは、左心耳(大静脈と回旋枝は房室弁輪と平行ではないが、左心室の尖端に向かって湾曲している場所)近傍の僧帽弁輪から、上肺静脈の上側を通り、そして右肺静脈近傍の僧帽弁輪に戻る、または下肺静脈の下側を通り、僧帽弁輪上部に向かう、「C」の作成を伴う。別の左心房病変パターンは、左心耳に近接する僧帽弁輪に交点があり、各部分は肺静脈の反対側を通過し、心房中隔の近傍で終端する「V」の作成を含む。左肺静脈または右肺静脈のいずれかの周囲に延びるそれぞれの湾曲した部分と、距離によって分離された中心結合を持ち、「B」の頂部線が左心耳近傍の僧帽弁輪につながる延びた「B」。左心耳近傍の僧帽弁輪に開始点を持ち、湾曲した部分内の対としてその基点から左および右肺静脈を取り囲む曲線を有する延びた「S」、逆「S」、または8の字の形状。上記の種々の左心房病変パターンに加えて、分界稜に沿って、下大静脈から上大静脈へ、分界稜から三尖弁輪、上大静脈から三尖弁輪、または右心房に沿う心房粗動を予防することができるその他の形状の右心房病変を作成してもよい。吸引凝固プローブが再現し得る、心房細動を治療できる代替的な潜在的な病変パターンは、米国特許第6,071,279号「Branched structures for supporting multiple electrode elements」において説明され、参照により本願に援用される。
コラーゲンが豊富な組織を収縮させるため、またはコラーゲン組織の収縮を防ぐための軟部組織の凝固を伴うその他の応用については、軟部組織の加熱はコントロールされなけらばならず、これは本発明の吸引凝固プローブのバリエーションによって可能である。熱に対する血管(動脈と静脈)の反応を評価する、発表された研究は、恒久的に血管を閉塞させる能力に重点を置いている。静脈は、70°Cを上回る温度、16秒で、自身の基準直径の何分の一かに縮む(完全な閉塞を含む程度まで)ことが示されており、動脈の収縮は静脈のものより著しく小さいが、90℃で16秒間さらされた場合、動脈でも自身の基準直径のおよそ半分まで収縮する(Gorisch et al. Heat−induced contraction of blood vessels. Lasers in Surgery and Medicine. 2:1−13, 1982; Cragg et al. Endovascular diathermic vessel occlusion. Radiology. 144:303− 308, 1982)。Gorischらは、観察された血管収縮反応を、「周辺に位置するコラーゲン線維束の熱収縮に起因する血内腔の半径方向の圧縮」と説明した。これらのコラーゲン原線維は、コラーゲン原線維に横紋パターンを失わせ、形のない物体に腫脹させる熱に反応して変性し、収縮するのが観察された。
「テラノスティック」は、診断装置や方法を用いることで治療処置の結果を決定する能力を意味する。下記で説明するバリエーションでは、テラノスティック装置は、治療用の低侵襲の外科手術が、その作業を終えた時点で効果的だったかどうかを決定する術中診断装置を意味する。
図18A〜18C、19A〜19H、20A〜20D、21A〜21Cは、脂肪組織(例えば、脂肪)および/または結合組織を心臓から除去、または分離するように設計された、本発明の切開/トンネリング器具124のバリエーションを示す。そのような作業の目的は、あらかじめ脂肪または結合組織によって覆われていようがいまいが、筋層を露出し、どのような場所でも吸引一体型凝固プローブを心臓組織に係合させるように動かせるようにすることである。
図23A〜23Cと図24A〜24Cは、脈管系を介して軟部組織にアクセスする、二つの機械的に振動する超音波切除カテーテルのバリエーション150の等角図、側面図、上面図を示す。これらのカテーテルバリエーションでは、組織を電気的に成長不能にするため、または別の熱誘導性の組織反応を引き起こすために、軟部組織を加熱することができるエネルギの伝達に電気ワイヤは必要ではない。
本願の方法は、対象装置を用いて、またはその他の手段によって実施されてもよい。方法はすべて、適切な装置を提供する作業を含んでもよい。そのような提供はエンドユーザによって行われてもよい。言い換えれば、「提供」(例えば、送達システム)は、アクセス、アプローチ、配置、セットアップ、作動、または対象方法において必須の装置を提供するその他の作業をエンドユーザが得るということが必要なだけである。本願に記載した方法は、論理的に可能であれば、記載したイベントをいずれの順番で行ってもよく、また記載したイベントの順番で行ってもよい。加えて、本発明のバリエーションは、その他の軟部組織、例えば***組織、肝臓、前立腺、胃腸組織、皮膚、または癌性細胞の凝固のためのその他の軟部組織の凝固や、熱誘導性縮小または収縮のためのその他のコラーゲンベースの軟部組織の凝固において用いられてもよい。
種々の例示的な本発明のバリエーションが下記で説明される。限定されない意味でこれらの例に言及する。それらは、より広く応用可能な本発明の態様を示すために提供される。本発明の真の精神と範囲から逸脱することなく、説明される本発明に対して種々の変更が行われてもよく、また均等のもので代用してもよい。さらに、特定の状況、材料、組成物、工程、工程作業(単独または複数)またはステップ(単独または複数)を本発明の目的、精神、または範囲に適合させるために、多くの改変が行われてもよい。そのような改変の全ては、本願に記載される特許請求の範囲に含まれるように意図される。例示的な本発明の態様を、材料の選択や製造の詳細とともに上記で説明した。本発明のその他の詳細については、これらは、当業者によって知られているまたは理解されているだけでなく、上記で引用した特許および研究発表との関連で理解されてもよい。
Claims (39)
- 臓器の軟部組織を凝固させる外科用装置であって、該外科用装置は、該軟部組織との接触を向上させるために吸引源とともに用いられ、該外科用装置は、
側壁と少なくとも一つのメイン内腔を含む第一の細長い筐体を有する細長いシャフトであって、該筐体は、該臓器周囲の曲がり対応し、該軟部組織への適合に対応するように柔軟であり、該筐体は、該素子と流体連通する液体送達内腔を含む、シャフトと、
該細長い筐体内に位置する素子と、
該素子を露出する該側壁を通る開口と、
該開口の少なくとも一部の周囲に位置し、該筐体に接続されるリップであって、該リップは、該開口から延びる部分を有し、該リップの該部分は、該リップが組織に適合することを可能にするように該筐体から独立して撓むように適合されており、該リップが組織に適合することが、メイン開口内に組織を引き込むように該開口内に真空を形成するために、該吸引源を該メイン内腔に適用した際に、該軟部組織に対するシールを形成する該リップの能力を向上させる、リップと
を含み、
該液体送達内腔は、該筐体の遠位端において該メイン内腔と流体連通し、液体送達中の該吸引源の適用および該シールの形成は、該素子への、そして該メイン内腔を通って戻る液体の循環をもたらす、外科用装置。 - 前記シャフトの近位端にハンドルをさらに含み、該ハンドルは、前記液体送達内腔と流体連通する液体送達ポートと、前記メイン内腔と流体連通する吸引ポートと、前記素子を電源に電気的に接続するためのコネクタとを含む、請求項1の外科用装置。
- 前記素子は、前記メイン内腔内に位置する、請求項1の外科用装置。
- 前記筐体の幅を最小化するために、前記液体送達内腔は、前記メイン内腔の上部を平行に、前記開口の正反対の位置で該筐体の一部を通って延びる、請求項1の外科用装置。
- 前記メイン内腔は、前記筐体の上部を通って延び、前記液体送達内腔は、該メイン内腔の一部を通って延び、前記開口は、該内腔に対して反対側の該筐体の底面にある、請求項1の外科用装置。
- 前記素子は、前記細長い筐体内の空洞内に位置し、前記メイン内腔は、該空洞の遠位部分と流体連通し、前記液体送達内腔は、該空洞の近位部分と流体連通する、請求項5の外科用装置。
- 前記メイン内腔内に位置するステアリング機構は、前記第一の細長い筐体の関節運動をもたらす、請求項1の外科用装置。
- 前記ステアリング機構は、予め成形されたスタイレットを含む、請求項7の外科用装置。
- 前記筐体は、該筐体に形を与えるように成形可能な脊椎部材をさらに含む、請求項1の外科用装置。
- 前記脊椎部材は、組織を凝固させるときに、前記素子が湾曲した凝固ラインを作成するように、第一の湾曲した形状を含む、請求項9の外科用装置。
- 前記細長いシャフトは、枝分かれし、第二の細長い筐体を含み、該第二の細長い筐体は、第二の側壁、第二のメイン内腔、該第二のメイン内腔内に位置する第二の素子、該第二の素子を露出する該第二の側壁を通る第二の開口を有し、第二のリップが、該第二の開口の少なくとも一部の周囲に位置し、前記第二の筐体に接続され、該第二のリップは、該第二の筐体と接続されていない部分を有し、該第二のリップの該部分は、前記吸引源を該第二のメイン内腔に適用した際に、組織に適合し、前記軟部組織に対してシールを形成する該第二のリップの能力を向上させる、請求項10の外科用装置。
- 第二の筐体は、該第二の筐体に第二の形状を与えるように成形可能な第二の脊椎部材をさらに含む、請求項11の外科用装置。
- 前記脊椎部材は、組織を凝固させるときに、第二の組織素子が湾曲した凝固ラインを作成するように、第二の湾曲した形状を含む、請求項12の外科用装置。
- 前記第一の湾曲した形状は、前記第一の細長い筐体の端部が前記第二の細長い筐体の端部からのオフセットを有するように、前記第二の湾曲した形状とは異なる、請求項13の外科用装置。
- 前記第一の湾曲した形状は、前記第二の湾曲した形状に類似している、請求項13の外科用装置。
- 前記筐体は、該筐体内部に固定され、遠位方向に該筐体から延びる少なくとも一つのテザーをさらに含む、請求項1の外科用装置。
- 前記筐体は、該筐体に固定され、遠位方向に該筐体から延びる、第二のテザーをさらに含む、請求項16の外科用装置。
- 前記テザーは、直径を大きくした区画を含み、該区画は、前記筐体内に固定される、請求項16の外科用装置。
- 前記素子は、少なくとも一つのピッチと少なくとも一つの巻き幅を有する少なくとも一つのらせん巻きを含む、請求項1の外科用装置。
- 前記ピッチは、前記幅の二倍以上である、請求項19の外科用装置。
- 前記ピッチは、前記幅の四倍以上である、請求項19の外科用装置。
- 前記開口に沿う前記側壁の外面は、ある距離だけ前記伝導性素子からのオフセットを有し、該開口の幅は、該オフセット距離以上である、請求項1の外科用装置。
- 前記開口の前記幅は、前記オフセット距離の二倍より大きい、請求項22の外科用装置。
- 前記素子は、マッピング電極を含む、請求項1の外科用装置。
- 前記素子は、組織を加熱するためにRFエネルギを伝達するように構成される電極を含む、請求項1の外科用装置。
- 前記素子は、該素子の抵抗加熱によって組織を加熱するように構成される電極である、請求項1の外科用装置。
- 前記素子は、組織に対して機械的エネルギを加えることによって組織を加熱するように構成される振動素子である、請求項1の外科用装置。
- 臓器の軟部組織を凝固させる外科用装置であって、該外科用装置は、該軟部組織との接触を向上させるために吸引源とともに用いられ、該外科用装置は、
側壁と少なくとも一つのメイン内腔を含む第一の細長い筐体を有する細長いシャフトであって、該筐体は該臓器周囲の曲がりに対応し、該軟部組織への適合に対応するように柔軟であるシャフトと、
該細長い筐体内に位置する素子と、
該素子を露出する該側壁を通る開口と、
該開口の少なくとも一部の周囲に位置し、該筐体に接続されるリップであって、該リップは、該開口から延びる部分を有し、該リップの該部分は、該リップが組織に適合することを可能にするように該筐体から独立して撓むように適合されており、該リップが組織に適合することが、メイン開口内に組織を引き込むように該開口内に真空を形成するために、該吸引源を該メイン内腔に適用した際に、該軟部組織に対するシールを形成する該リップの能力を向上させる、リップと
該メイン内腔と流体連通する液体送達内腔であって、該液体送達内腔は、該筐体の幅を最小化するために、該筐体の一部に位置し、該筐体の一部は、該メイン内腔に隣接し、該開口に対して正反対の位置にある、液体送達内腔と
を含み、
該液体送達内腔は、該筐体の遠位端において該メイン内腔と流体連通し、液体送達中の該吸引源の適用および該シールの形成は、該素子への、そして該メイン内腔を通って戻る液体の循環をもたらす、外科用装置。 - 前記素子は、前記メイン内腔内に位置する、請求項28の外科用装置。
- 前記メイン内腔内に位置するステアリング機構は、前記第一の細長い筐体の関節運動をもたらす、請求項28の外科用装置。
- 前記ステアリング機構は、予め成形されたスタイレットを含む、請求項30の外科用装置。
- 前記シャフトの近位端にあるハンドルをさらに含み、該ハンドルは、前記液体送達内腔と流体連通する液体送達ポート、前記メイン内腔と流体連通する吸引ポート、前記素子と電源を電気的につなぐコネクタを含む、請求項28の外科用装置。
- 前記第一の細長い筐体は、該第一の細長い筐体に第一の形状を与えるように成形可能な第一の脊椎部材をさらに含む、請求項28の外科用装置。
- 前記第一の脊椎部材は、組織を凝固させるとき、前記素子が湾曲した凝固ラインを作成するように、第一の湾曲した形状を含む、請求項33の外科用装置。
- 前記細長いシャフトは、枝分かれし、第二の細長い筺体を含み、該第二の細長い筺体は、第二の側壁、第二のメイン内腔、該第二のメイン内腔内に位置する第二の素子、該第二の素子を露出する該第二の側壁を通る第二の開口、前記第一のメイン内腔と流体連通する第二の液体送達内腔とを有し、該第二の液体送達内腔は、該第二の筐体の幅を最小化するために、該第二の筐体の一部に位置し、該第二の筐体の一部は、該第二のメイン内腔に隣接し、該第二の開口に対して正反対の位置にある、請求項34の外科用装置。
- 前記第二の細長い筐体は、該第二の細長い筐体に第二の形状を与えるように成形可能な第二の脊椎部材をさらに含む、請求項35の外科用装置。
- 前記第二の脊椎部材は、組織を凝固させるとき、前記第二の素子が湾曲した凝固ラインを作成するように、第二の湾曲した形状を含む、請求項36の外科用装置。
- 前記第一の湾曲した形状は、前記第一の細長い筐体の端部が前記第二の細長い筐体の端部からのオフセットを有するように、前記第二の湾曲した形状とは異なる、請求項37の外科用装置。
- 前記第一の湾曲した形状は、前記第二の湾曲した形状に類似している、請求項37の外科用装置。
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Cited By (1)
Publication number | Priority date | Publication date | Assignee | Title |
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EA038181B1 (ru) * | 2018-12-17 | 2021-07-20 | Учреждение образования "Витебский государственный ордена Дружбы народов медицинский университет" | Способ мини-vac-реторакотомии |
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US20190388145A1 (en) | 2019-12-26 |
US7572257B2 (en) | 2009-08-11 |
US20150265338A1 (en) | 2015-09-24 |
EP1922007A1 (en) | 2008-05-21 |
US20120179150A1 (en) | 2012-07-12 |
EP2759274A1 (en) | 2014-07-30 |
EP1922007A4 (en) | 2011-11-30 |
US8034053B2 (en) | 2011-10-11 |
US10342610B2 (en) | 2019-07-09 |
US20070043351A1 (en) | 2007-02-22 |
WO2007037785A1 (en) | 2007-04-05 |
US20060293646A1 (en) | 2006-12-28 |
US11364074B2 (en) | 2022-06-21 |
US20090254009A1 (en) | 2009-10-08 |
US8998900B2 (en) | 2015-04-07 |
JP2009504313A (ja) | 2009-02-05 |
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