JP2010533033A - 患者内の通路にエネルギーを伝達するためのシステムおよび方法 - Google Patents
患者内の通路にエネルギーを伝達するためのシステムおよび方法 Download PDFInfo
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Abstract
Description
本発明は、患者内の通路にエネルギーを伝達するためのシステムおよび方法に関し、例えば患者の肺内の気道にエネルギーを伝達することにより、気流に対する抵抗を低減するためのシステムおよび方法に関する。
喘息は、呼吸を困難にする病気であり、多くの場合において、患者を衰弱させ得る。一般的に喘息には、(i)気管支収縮、(ii)過剰な粘液生成、および/または(iii)広範囲に及ぶ様々な気流障害を生じる気道の炎症および腫脹、といった症状が見られる。喘息は、しばしば持続的な気道の炎症によって特徴付けられる慢性疾患であり得るが、喘息はさらに、過敏症の気道平滑筋組織の収縮によるさらなる気道狭窄の発作によって特徴付けられ得る。
以下では、本開示のいくつかの実施形態の特定の詳細が、患者内の通路にエネルギーを伝達するためのシステムおよび方法に関して記載される。以下では、多くの実施形態が、喘息を治療するために患者の肺内の気道に無線周波数エネルギーを伝達することに関して記載されるが、他の適応症を治療するために他のエネルギー様式を肺気道または他のタイプの通路に伝達する他の実施形態もまた、本発明の範囲内にあり得る。例えば、他のタイプのエネルギー様式は、熱(抵抗性の熱および/または赤外線の熱)、マイクロ波、レーザ、超音波(例えば、HIFU)、冷凍切除(cryo−ablation)、放射線、および/または他のエネルギー様式を含み得る。さらに、本発明のいくつかのほかの実施形態は、このセクションに記載されているものとは異なる構成、コンポーネント、または手順を有し得る。したがって当業者は、本発明はさらなる要素を有する他の実施形態を有し得ること、または、本発明は図2A〜図8に関連して以下に示され記載される特徴のうちのいくつかを除いた他の実施形態を有し得ることを、しかるべく理解するであろう。さらに、上記の記載は単に例示を目的としており、システムまたはデバイスの実際の形状、サイズ、または寸法を必ずしも反映していないことが理解されるであろう。
Claims (32)
- 患者内の内部通路における組織を治療する方法であって、
アクセスデバイスを患者の肺気道に配置することと、
細長い本体の遠位端におけるエネルギー伝達ユニットが該アクセスデバイスから突出するまで、該アクセスデバイスに沿って治療デバイスの細長い本体を前進させることと、
エネルギー伝達要素が該気道の側壁に接触するように該エネルギー伝達ユニットを拡張させることと、
該気道の該側壁にエネルギーが伝達されるように該治療デバイスに結合されたエネルギー供給源を活性化することであって、該エネルギー伝達ユニットを拡張させ、該エネルギー供給源を活性化させている間に、一人の人間が、該アクセスデバイスと該治療デバイスとの両方を物理的に操作する、ことと
を含む、方法。 - 前記一人の人間は、前記エネルギー供給源を活性化させる間に、前記アクセスデバイスと前記治療デバイスとの両方を保持する、請求項1に記載の方法。
- 前記細長い本体を前進させることは、前記アクセスデバイスの作業ルーメンを通して該細長い本体を押す間に、前記一人の人間の1つの手の親指の末節骨と人差し指の末節骨とによって該細長い本体を保持することを含み、
前記エネルギー伝達ユニットを拡張させることは、該一人の人間の該1つの手の第2の指から第4の指のうちの1つによってアクチュエータを動かすことを含み、該アクチュエータは、該エネルギー伝達ユニットに操作可能なように結合されている、請求項1に記載の方法。 - 前記アクチュエータは、第1の部分と第2の部分とを有するハンドルの一部分であり、
該アクチュエータを動かすことは、前記一人の人間の前記1つの手において該第1の部分と該第2の部分とを圧搾することを含む、請求項3に記載の方法。 - 前記アクセスデバイスを配置することは、前記一人の人間の第1の手によって前記肺気道を通して気管支鏡を動かすことを含み、
前記細長い本体を前進させることは、該一人の人間の第2の手によって該気管支鏡の作業ルーメンを通して該細長い本体を押すことを含み、
前記エネルギー伝達ユニットを拡張させることは、該一人の人間の該第2の手によって該エネルギー伝達ユニットに操作可能なように結合されたアクチュエータを動かすことを含む、請求項1に記載の方法。 - 前記第2の手によって前記細長い本体を前進させることは、前記作業ルーメンを通して該細長い本体を押す間に、該一人の人間の該第2の手の親指の末節骨と人差し指の末節骨とによって該細長い本体を保持することを含み、
前記エネルギー伝達ユニットを拡張させることは、該第2の手によって前記アクチュエータを動かすことを含み、該動かすことは、該一人の人間の該第2の手の第2の指から第4の指のうちの1つによってハンドルを圧搾することを含む、請求項5に記載の方法。 - 前記ハンドルは、第1の部分と該第1の部分に回転可能なように取り付けられた第2の部分とを含み、前記細長い本体は、該第1の部分および該第2の部分のうちの1つに結合されており、該細長い本体内のワイヤが、該第1の部分および該第2の部分のうちの1つに結合されており、その結果、該第1の部分と該第2の部分との間の相対的回転が、該細長い本体に沿って該ワイヤを長手方向に動かし、該第1の部分は第1の湾曲表面を有し、該第2の部分は第2の湾曲表面を有し、該第1の湾曲表面と該第2の湾曲表面とは、該第1の湾曲表面と該第2の湾曲表面とが双曲線のような形状のグリップを画定するように配置され、
該ハンドルを圧搾することは、該第1の部分と該第2の部分とを互いに対して回転させることを含む、請求項6に記載の方法。 - 前記ハンドルは、グリップと、前記細長い本体に結合され、該グリップの上部分に位置するヘッドと、該細長い本体内のワイヤに結合されたアクチュエータ機構とを含み、該ヘッドは、該グリップの一部分が該ヘッドよりも狭くなるように、該グリップから外側に突出しており、
該ハンドルを圧搾することは、該アクチュエータ機構を動かすことを含む、請求項6に記載の方法。 - 患者の内部肺気道を治療する方法であって、
アクセスデバイスが患者の肺気道内にある間に、オペレータの第1の手にアクセスデバイスを保持することと、
前記治療デバイスのカテーテルが該アクセスデバイスに配置され、該カテーテルに取り付けられたエネルギー伝達ユニットが該アクセスデバイスの端部を越えて配置されるように、該オペレータの該第2の手に治療デバイスを保持することと、
該オペレータの該第1の手が該アクセスデバイスを保持している間に、該エネルギー伝達ユニットの一部分が該気道の側壁に接触するように、該オペレータの該第2の手を用いて該治療デバイスのアクチュエータを動かし、該気道にエネルギーを伝達することと
を含む、方法。 - 前記治療デバイスを保持することは、前記アクセスデバイスの作業ルーメンを通して前記カテーテルを押す間に、前記オペレータの前記第2の手の親指の末節骨と人差し指の末節骨とによって該カテーテルをつまむことを含み、
前記アクチュエータを動かすことは、該オペレータの該第2の手の第2の指から第4の指のうちの1つによってハンドルを把持することを含む、請求項9に記載の方法。 - 前記ハンドルは、第1の部分と第2の部分を含み、前記アクチュエータを動かすことは、前記オペレータの前記第2の手において該第1の部分と該第2の部分とを圧搾することを含む、請求項10に記載の方法。
- 前記アクセスデバイスを保持することは、前記オペレータの前記第1の手および/または前記第2の手によって前記気道を通して気管支鏡を動かすことを含み、
前記治療デバイスを保持することは、該オペレータの該第2の手によって該気管支鏡の作業ルーメンを通して前記カテーテルを押すことを含む、請求項9に記載の方法。 - 前記第2の手によって前記カテーテルを押すことは、前記オペレータの該第2の手の親指の末節骨と人差し指の末節骨とによって該カテーテルをグリップすることを含み、
該第2の手によって該アクチュエータを動かすことは、該オペレータの該第2の手の第2の指から第4の指のうちの1つによってハンドルを圧搾することを含む、請求項12に記載の方法。 - 患者の内部肺気道を治療する方法であって、
一人の人間の第1の手によって気管支鏡を制御することにより、該患者の肺気道に該気管支鏡の遠位端を配置することと、
該一人の人間の第2の手によって治療デバイスを動かすことにより、該治療デバイスの電極アセンブリが該肺気道の第1の治療部位において該気管支鏡の遠位端を越えて突出するまで、該気管支鏡の作業ルーメンを通して可撓性カテーテルをスライドさせることと、
該一人の人間の該第1の手と該第2の手とのうちの1つによって該カテーテルと該気管支鏡とを保持する間に、該一人の人間の該第2の手によって該治療デバイスのアクチュエータを圧搾することであって、該アクチュエータは、該電極アセンブリの電極を外側に動かす、ことと、
該一人の人間が該気管支鏡と該治療デバイスとを保持している間に、該電極を通して該第1の治療部位にエネルギーを印加することと
を含む、方法。 - 前記第2の手によって前記治療デバイスを動かすことは、前記作業ルーメンを通して前記カテーテルをスライドさせている間に、前記一人の人間の該第2の手の親指の末節骨と人差し指の末節骨とによって該カテーテルをつまむことを含み、
該第2の手によって前記アクチュエータを圧搾することは、該一人の人間の該第2の手の第2の指から第4の指のうちの1つによってハンドルを圧搾することを含む、請求項14に記載の方法。 - 前記ハンドルは、第1の部分と該第1の部分に回転可能なように取り付けられた第2の部分とを含み、前記カテーテルは、該第1の部分および該第2の部分のうちの1つに結合されており、該カテーテル内のワイヤが、該第1の部分および該第2の部分のうちの1つに結合されており、その結果、該第1の部分と該第2の部分との間の相対的回転が、該カテーテルに沿って該ワイヤを長手方向に動かし、該第1の部分は第1の湾曲表面を有し、該第2の部分は第2の湾曲表面を有し、該第1の湾曲表面と該第2の湾曲表面とは、該第1の湾曲表面と該第2の湾曲表面とが双曲線のような形状のグリップを画定するように配置され、
該ハンドルを圧搾することは、該第1の部分と該第2の部分とを互いに対して回転させることを含む、請求項15に記載の方法。 - 前記ハンドルは、グリップと、前記カテーテルに結合され、該グリップの上部分に位置するヘッドと、該カテーテル内のワイヤに結合されたアクチュエータ機構とを含み、該ヘッドは、該グリップの一部分が該ヘッドよりも狭くなるように、該グリップから外側に突出しており、
該ハンドルを圧搾することは、該アクチュエータ機構を動かすことを含む、請求項15に記載の方法。 - 無線周波数エネルギー伝達デバイスであって、
細長い本体であって、近位部分と、遠位部分と、該近位部分および該遠位部分に沿って延びているルーメンとを有する細長い本体と、
該ルーメンを通って延びているワイヤと、
該細長い本体の該遠位部分におけるエネルギー伝達要素であって、該ワイヤに取り付けられているエネルギー伝達要素と、
ハンドルであって、グリップと、該細長い本体の該近位部分に結合され、該グリップの上部分に位置するヘッドと、該ワイヤに結合されたアクチュエータ機構とを有し、該ヘッドは、該グリップの一部分が該ヘッドよりも狭くなるように、該グリップから外側に突出している、ハンドルと
を含む、エネルギー伝達デバイス。 - 前記ハンドルは、第1の部分と該第1の部分に回転可能なように取り付けられた第2の部分とを含み、前記アクチュエータは、該第1の部分および該第2の部分のうちの1つによって画定される、請求項18に記載のエネルギー伝達デバイス。
- 前記第2の部分は、ノッチ付のフランジを有し、前記第1の部分は、該第1の部分に旋回可能なように取り付けられたレバーを有し、該レバーは、該ノッチ内の第1の端部と、該ワイヤに取り付けられた第2の端部とを有する、請求項19に記載のエネルギー伝達デバイス。
- 前記エネルギー伝達要素は電極を含む、請求項18に記載のエネルギー伝達デバイス。
- 前記細長い本体は、カテーテルを含み、該カテーテルは、内壁を有するカバーと、該カバーの該内壁に結合されたコイルと、該コイル内のルーメンとを含み、該ワイヤは、該コイルの該ルーメンを通って延びている、請求項18に記載のエネルギー伝達デバイス。
- 無線周波数エネルギー伝達デバイスであって、
細長い本体であって、近位部分と、遠位部分と、該近位部分および該遠位部分に沿って延びているルーメンとを有する細長い本体と、
該ルーメンを通って延びている部材と、
該細長い部材の該遠位部分における電極ユニットであって、該部材に取り付けられており、電極を有する電極ユニットと、
ハンドルであって、第1の部分と該第1の部分に回転可能なように取り付けられた第2の部分とを有し、該細長い本体の該近位端は、該第1の部分および該第2の部分のうちの1つに結合されており、該部材が、該第1の部分および該第2の部分のうちの1つに結合されており、その結果、該第1の部分と該第2の部分との間の相対的回転が、該細長い本体に沿って該部材を長手方向に動かし、該第1の部分は第1の湾曲表面を有し、該第2の部分は第2の湾曲表面を有し、該第1の湾曲表面と該第2の湾曲表面とは、該第1の湾曲表面と該第2の湾曲表面とが双曲線のような形状のグリップを画定するように配置される、ハンドルと
を含む、エネルギー伝達デバイス。 - 前記第2の部分は、ノッチ付のフランジを有し、前記第1の部分は、該第1の部分に旋回可能なように取り付けられたレバーを有し、該レバーは、該ノッチ内の第1の端部と、前記部材に取り付けられた第2の端部とを有する、請求項23に記載のエネルギー伝達デバイス。
- 前記細長い本体は、カテーテルを含み、該カテーテルは、内壁を有するカバーと、該カバーの該内壁に結合されたコイルと、該コイル内のルーメンとを含み、前記部材は、該コイルの該ルーメンを通って延びている、請求項23に記載のエネルギー伝達デバイス。
- 無線周波数エネルギー伝達デバイスであって、
細長い本体であって、内壁を有するカバーと、該カバーの該内壁に結合されたコイルと、該コイル内のルーメンとを含む細長い本体と、
該ルーメンを通って延びているワイヤと、
該細長い本体の遠位部分におけるエネルギー伝達ユニットであって、該エネルギー伝達ユニットは、該細長い本体に固定された近位保持部と、該ワイヤに取り付けられた遠位保持部と、該近位保持部に取り付けられた近位端と該遠位保持部に取り付けられた遠位端とを有する複数の可撓性電極とを有するエネルギー伝達ユニットと、
ハンドルであって、グリップと、該細長い本体の近位部分に結合され、該グリップの上部分に位置するヘッドと、該ワイヤに結合されたアクチュエータ機構とを有し、該ヘッドは、該グリップの一部分が該ヘッドよりも狭くなるように、該グリップから外側に突出している、ハンドルと
を含む、エネルギー伝達デバイス。 - 前記ハンドルの前記アクチュエータのストローク長さは、約5mm〜約40mmの範囲である、請求項26に記載のエネルギー伝達デバイス。
- 患者の内部肺気道を治療する方法であって、
細長い本体の遠位部分におけるエネルギー伝達ユニットが第1の治療部位に配置されるまで、患者の肺気道に治療デバイスの細長い本体を配置することと、
エネルギー伝達要素が該第1の治療部位において該気道の側壁に接触するように該エネルギー伝達ユニットを拡張させることと、
該第1の治療部位において該気道の該側壁にエネルギーを伝達することであって、オペレータの1つの手は、エネルギー伝達中に該エネルギー伝達ユニットの拡張を維持する間に、同時に該細長い本体の配置を制御する、ことと
を含む、方法。 - 前記細長い本体を配置することは、該細長い本体を前記オペレータの1つの手の親指の末節骨と人差し指の末節骨とによって保持することを含み、
前記エネルギー伝達ユニットを拡張させることは、該オペレータの該1つの手の第2の指から第4の指によってアクチュエータを動かすことを含み、該アクチュエータは、該エネルギー伝達ユニットに操作可能なように結合される、請求項28に記載の方法。 - エネルギー伝達中に前記オペレータの前記1つの手または他の手によって前記治療デバイスをスライド可能なように受容するアクセスデバイスを同時に制御すること
をさらに含み、
前記細長い本体を配置することは、エネルギー伝達中に該アクセスデバイスに対して該細長い本体を保持することを含む、請求項28に記載の方法。 - 前記エネルギー伝達ユニットを収縮させることと、前記細長い本体を第2の治療部位に配置することと、該エネルギー伝達ユニットを該第2の治療部位において拡張させることと、該第2の治療部位にエネルギーを伝達することと
をさらに含む、請求項28に記載の方法。 - 所望の治療パターンが達成されるまで、前記収縮させることと、配置することと、拡張させることと、伝達することとを繰り返すこと
をさらに含む、請求項31に記載の方法。
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2007
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2008
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- 2008-06-05 EP EP08756715.2A patent/EP2170459B1/en active Active
- 2008-06-05 EP EP13003642.9A patent/EP2653127B1/en active Active
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- 2008-06-05 WO PCT/US2008/065867 patent/WO2009009236A1/en active Application Filing
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2012
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2019
- 2019-06-24 US US16/449,952 patent/US11478299B2/en active Active
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US20090018538A1 (en) | 2009-01-15 |
US11478299B2 (en) | 2022-10-25 |
EP2653127B1 (en) | 2017-11-22 |
AU2008275444A1 (en) | 2009-01-15 |
US20230000551A1 (en) | 2023-01-05 |
WO2009009236A1 (en) | 2009-01-15 |
CA2693769A1 (en) | 2009-01-15 |
EP2170459A4 (en) | 2010-09-29 |
EP2653127A1 (en) | 2013-10-23 |
EP2170459A1 (en) | 2010-04-07 |
US20200008868A1 (en) | 2020-01-09 |
US10368941B2 (en) | 2019-08-06 |
ES2453152T3 (es) | 2014-04-04 |
US20120330299A1 (en) | 2012-12-27 |
US8235983B2 (en) | 2012-08-07 |
EP2170459B1 (en) | 2014-02-26 |
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