JP5545668B2 - マイクロ波エネルギーを用いる非侵襲性組織治療のためのシステム、装置方法、および手技 - Google Patents
マイクロ波エネルギーを用いる非侵襲性組織治療のためのシステム、装置方法、および手技 Download PDFInfo
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- A61B18/12—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body by heating by passing a current through the tissue to be heated, e.g. high-frequency current
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Description
本願は、米国仮特許出願第61/196,948号(名称「SYSTEMS AND METHODS FOR CREATING AN EFFECT USING MICROWAVE ENERGY TO SPECIFIED TISSUE,SUCH AS SWEAT GLANDS」、2008年10月22日出願)の利益を主張し、この出願の開示は、その全体が本明細書に参考として明示的に援用される。
本出願は、マイクロ波療法の非侵襲性送達のための方法、装置、およびシステムに関する。具体的には、本出願は、種々の治療および/または審美的結果を達成するように、例えば、マイクロ波エネルギー等のエネルギーを、患者の表皮、真皮、および皮下組織に非侵襲的に送達するための方法、装置、およびシステムに関する。
多数の治療および/または審美的結果を達成するように、エネルギーに基づいた治療法を全身の組織に適用できることが知られている。これらのエネルギーに基づいた治療法の有効性を改善し、最小の副作用または不快感とともに、向上した治療結果を提供する継続的な必要性が残っている。
本発明は、例えば、以下を提供する:
(項目1)
使い捨て医療装置であって、
使い捨て部材の遠位端に配置される、組織チャンバと、
該使い捨て部材の近位端に配置される、アプリケータチャンバと、
該組織チャンバと該アプリケータとの界面を分離する、組織生体障壁と、
該組織チャンバと該アプリケータチャンバとを接続する、真空回路と
を備える、使い捨て医療装置。
(項目2)
上記組織チャンバは、組織界面を備え、
該組織界面は、
組織生体障壁を包囲する、真空チャネルと、
該真空チャネルおよび真空回路と流動連通している、真空ポートと、
該組織チャンバを包囲する、チャンバ壁と
を備える、項目1に記載の使い捨て医療装置。
(項目3)
上記チャンバ壁はさらに、柔軟部材を含む、項目2に記載の使い捨て医療装置。
(項目4)
上記柔軟部材は、約0.15インチと約0.25インチとの間の高さを有する、項目3に記載の使い捨て医療装置。
(項目5)
上記柔軟部材は、約0.25インチの高さを有する、項目3に記載の使い捨て医療装置。
(項目6)
上記チャンバ壁はさらに、該チャンバ壁の少なくとも一部分を被覆する潤滑剤を含む、項目2に記載の使い捨て医療装置。
(項目7)
上記潤滑剤は、シリコーン油、テフロン(登録商標)、パラレン、または組織の取得を容易にする他の好適な被覆材料から成る群より選択される、項目6に記載の使い捨て医療装置
(項目8)
上記チャンバ壁は、項目2に記載の使い捨て医療装置。
(項目9)
上記アプリケータチャンバは、
アプリケータ界面であって、上記組織生体障壁を包囲する、アプリケータ界面と、
該アプリケータ界面を包囲する、アプリケータ界面壁と、
該アプリケータチャンバの近位端における真空シールであって、該真空シールは、アプリケータが該アプリケータチャンバ内に配置されるときに、該アプリケータチャンバを密封するように配置される、真空シールと
を備える、項目1に記載の使い捨て医療装置。
(項目10)
上記アプリケータチャンバは、アプリケータを受容し、かつ、係合するのに十分な深度を有することにより、該アプリケータの遠位端が上記組織生体障壁に接触して、該アプリケータの該遠位端と該組織生体障壁との間に締まり嵌めを生成する、項目9に記載の使い捨て医療装置。
(項目11)
上記アプリケータチャンバは、該アプリケータチャンバ内に配置されるアプリケータが、上記生体障壁を上記組織チャンバの中に約0.001インチと約0.030インチとの間で移動させることを確実にするのに十分な深度を有する、項目10に記載の使い捨て医療装置。
(項目12)
上記アプリケータチャンバは、該アプリケータチャンバ内に配置されるアプリケータが、上記生体障壁を上記組織チャンバの中に約0.010インチ移動させることを確実にするのに十分な深度を有する、項目10に記載の使い捨て医療装置。
(項目13)
上記アプリケータチャンバは、アプリケータを受容し、かつ、係合するのに十分な深度を有することにより、該アプリケータの遠位端が上記組織生体障壁に接触し、組織が上記組織チャンバ内に配置されるときに、該アプリケータの該遠位端と該組織生体障壁との間で締まり嵌めを生成する、項目9に記載の使い捨て医療装置。
(項目14)
上記組織生体障壁は、可撓性である、項目1に記載の使い捨て医療装置。
(項目15)
上記組織生体障壁は、フィルムである、項目14に記載の使い捨て医療装置。
(項目16)
上記組織生体障壁は、0.0001インチと約0.030インチとの間の厚さを有する、項目15に記載の使い捨て医療装置。
(項目17)
上記組織生体障壁は、約0.0005インチの厚さを有する、項目15に記載の使い捨て医療装置。
(項目18)
上記真空回路は、
主要真空チャネルであって、上記アプリケータチャンバと流動連通している、主要真空チャネルと、
該主要真空チャネルおよび上記組織チャンバの両方と流動連通している、真空ポートと
を備える、項目1に記載の使い捨て医療装置。
(項目19)
上記真空回路は、
上記主要真空チャネルと流動連通している、真空コネクタと、
該主要真空チャネルと上記アプリケータチャンバとの間に配置される、アプリケータ生体障壁と
をさらに備える、項目18に記載の使い捨て医療装置。
(項目20)
上記アプリケータ生体障壁は、上記使い捨て医療装置の第1の側面上に配置され、上記真空コネクタは、該使い捨て医療装置の第2の側面上に配置される、項目19に記載の使い捨て医療装置。
(項目21)
上記主要真空チャネルは、上記真空コネクタと上記アプリケータ生体障壁との間に蛇行経路を含む、項目20に記載の使い捨て医療装置。
(項目22)
上記主要真空チャネルは、上記アプリケータ生体障壁に隣接して配置される、真空バッフルをさらに備える、項目21に記載の使い捨て医療装置。
(項目23)
上記真空ポートは、上記真空コネクタと上記真空バッフルとの間で上記主要真空チャネルに接触する、項目22に記載の使い捨て医療装置。
(項目24)
治療デバイス内の真空圧の平衡を保つ方法であって、該治療デバイスは、アプリケータと、使い捨て部品とを備え、該使い捨て部品は、可撓性組織生体障壁によって分離される、組織チャンバとアプリケータチャンバとを備えており、該方法は、
該アプリケータチャンバ内に該アプリケータを配置することにより、該アプリケータが該アプリケータチャンバ開口部を密閉する、ステップと、
該組織チャンバに隣接して組織を配置することにより、該組織が組織チャンバ開口部を少なくとも部分的に密閉する、ステップと、
該組織チャンバから空気を引き出すステップと、
該アプリケータチャンバから空気を引き出すステップと
を含む、方法。
(項目25)
上記方法は、上記アプリケータチャンバ内に上記アプリケータを配置することにより、該アプリケータの遠位端が上記組織生体障壁との締まり嵌めを形成する、ステップをさらに含む、項目24に記載の治療デバイス内の真空圧の平衡を保つ方法。
(項目26)
上記方法は、上記アプリケータチャンバの中に上記アプリケータを配置することにより、該アプリケータの遠位端が上記組織生体障壁を上記組織チャンバの中へ伸展させる、ステップをさらに含む、項目25に記載の治療デバイス内の真空圧の平衡を保つ方法。
(項目27)
上記組織生体障壁を上記組織チャンバの中へ約0.001インチと約0.030インチとの間の距離だけ伸展させるステップをさらに含む、項目26に記載の治療デバイス内の真空圧の平衡を保つ方法。
(項目28)
上記組織生体障壁を上記組織チャンバの中へ約0.010インチの距離だけ伸展させるステップをさらに含む、項目26に記載の治療デバイス内の真空圧の平衡を保つ方法。
(項目29)
アプリケータチャンバから空気を引き出す上記ステップは、生体障壁を通して空気を引き出すステップを含む、項目24に記載の治療デバイス内の真空圧の平衡を保つ方法。
(項目30)
治療デバイスを使用して、真皮の第1の領域より下の皮膚組織の領域内に傷害を生成する方法であって、該治療デバイスは、アプリケータを備え、該アプリケータは、冷却板と、使い捨て部品とを備え、該使い捨て部品は、組織チャンバと、可撓性の組織生体障壁によって分離されるアプリケータチャンバとを備え、該方法は、
該アプリケータがアプリケータチャンバ開口部を密閉するように、該アプリケータチャンバ内に該アプリケータを配置するステップと、
該皮膚組織が組織チャンバ開口部を少なくとも部分的に密閉するように、該組織チャンバに隣接して該皮膚組織を配置するステップと、
該組織チャンバから空気を引き出すステップと、
該組織を該アプリケータチャンバに引き込むように、該アプリケータチャンバから空気を引き出すステップと、
該冷却板および該組織生体障壁を通して電磁エネルギーを伝達するステップと
を含む、方法。
(項目31)
上記方法は、上記アプリケータの遠位端が上記組織生体障壁との締まり嵌めを形成するように、上記アプリケータチャンバ内に該アプリケータを配置するステップをさらに含む、項目30に記載の治療デバイス内の真空圧の平衡を保つ方法。
(項目32)
上記方法は、上記アプリケータの遠位端が上記組織生体障壁を上記組織チャンバの中へ伸展させるように、上記アプリケータチャンバ内に該アプリケータを配置するステップをさらに含む、項目31に記載の治療デバイス内の真空圧の平衡を保つ方法。
(項目33)
上記組織生体障壁を上記組織チャンバの中へ約0.001インチと約0.030インチと間の距離だけ伸展させるステップをさらに含む、項目32に記載の治療デバイス内の真空圧の平衡を保つ方法。
(項目34)
上記組織生体障壁を上記組織チャンバの中へ約0.010インチの距離だけ伸展させるステップをさらに含む、項目32に記載の治療デバイス内の真空圧の平衡を保つ方法。
(項目35)
アプリケータチャンバから空気を引き出す上記ステップは、生体障壁を通して空気を引き出すステップを含む、項目31に記載の治療デバイス中の真空圧の平衡を保つ方法。
(項目36)
上記アプリケータの遠位端における使い捨てインターフェースであって、使い捨て係合機構を備える、使い捨てインターフェースと、
該アプリケータの該遠位端を通してエネルギーを伝達するように配設されるアンテナ構造であって、少なくとも1つのアンテナ開口を含む、アンテナ構造と、
冷却板を含む冷却回路であって、該冷却回路の少なくとも一部分は、該アンテナと該アプリケータの該遠位端との間に配置される、冷却回路と
を備える、エネルギー伝達アプリケータ。
(項目37)
上記アンテナは、
複数のアンテナと、
該複数のアンテナに上記エネルギーを伝達するように配設される、分配要素と
を備える、項目36に記載のエネルギー伝達アプリケータ。
(項目38)
上記分配要素は、マイクロ波スイッチを備える、項目37に記載のエネルギー伝達アプリケータ。
(項目39)
上記分配要素は、電力分割器を備える、項目37に記載のエネルギー伝達アプリケータ。
(項目40)
上記エネルギー伝達アプリケータは、上記開口と上記アプリケータの上記遠位端との間に配置される、散乱要素をさらに備える、項目36に記載のエネルギー伝達アプリケータ。
(項目41)
上記冷却回路は、上記アンテナ開口と上記冷却板の近位側面との間に配置される、冷却チャンバをさらに備える、項目36に記載のエネルギー伝達アプリケータ。
(項目42)
上記アプリケータの遠位端における使い捨てインターフェースであって、使い捨て係合機構を備える、使い捨てインターフェースと、
複数のアンテナ開口を含む導波管アセンブリであって、該複数のアンテナ開口は、該アプリケータの該遠位端を通してエネルギーを伝達するように配設される、導波管アセンブリと、
冷却板を含む冷却回路であって、該冷却回路の少なくとも一部分は、該アンテナと該アプリケータの該遠位端との間に配置される、冷却回路と
を備える、エネルギー伝達アプリケータ。
(項目43)
上記導波管アセンブリは、
アンテナクレードルの中に配置される、複数の導波管アンテナと、
上記複数のアンテナに上記エネルギーを伝達するように配設される、分配要素と
を備える、項目42に記載のエネルギー伝達アプリケータ。
(項目44)
上記分配要素は、マイクロ波スイッチを備える、項目43に記載のエネルギー伝達アプリケータ。
(項目45)
上記分配要素は、電力分割器を備える、項目43に記載のエネルギー伝達アプリケータ。
(項目46)
上記エネルギー伝達アプリケータはさらに、上記開口と上記アプリケータの上記遠位端との間に配置される、散乱要素を備える、項目42に記載のエネルギー伝達アプリケータ。
(項目47)
上記冷却回路はさらに、上記アンテナ開口と上記冷却板の近位側面との間に配置される、冷却チャンバを備える、項目42に記載のエネルギー伝達アプリケータ。
(項目48)
上記導波管アセンブリは、
アンテナクレードル内に配置される、複数の導波管アンテナと、
該複数のアンテナに上記エネルギーを伝達するように配設される、分配要素と
を備える、項目47に記載のエネルギー伝達アプリケータ。
(項目49)
上記冷却回路はさらに、上記アンテナクレードル内に冷却通路を備え、該冷却通路は、上記冷却チャンバに接続される、項目48に記載のエネルギー伝達アプリケータ。
(項目50)
上記導波管アセンブリは、
複数の導波管アンテナと、
該アンテナの間に配置される、複数の隔離要素と
を備える、項目42に記載のエネルギー伝達アプリケータ。
(項目51)
上記導波管アセンブリは、
該導波管アセンブリの第1端に配置される、第1の隔離要素と、
該導波管アセンブリの第2端に配置される、第2の隔離要素と
をさらに備える、項目50に記載のエネルギー伝達アプリケータ。
(項目52)
上記隔離要素は、マイクロ波吸収材料のシムを備える、項目51に記載のエネルギー伝達アプリケータ。
(項目53)
上記隔離要素は、マイクロ波チョークを備える、項目51に記載のエネルギー伝達アプリケータ。
(項目54)
上記導波管アンテナは、
内側誘電体と、
上記開口を除く全側面上の該内側誘電体を包囲する、外殻と
を備える、項目50に記載のエネルギー伝達アプリケータ。
(項目55)
上記冷却板は、
近位面と、
遠位面と、
該遠位面内の1つ以上の熱電対溝と、
該熱電対溝内に配置される、1つ以上の熱電対と
を備える、項目42に記載のエネルギー伝達アプリケータ。
(項目56)
上記熱電対溝は、上記伝達エネルギーがマイクロ波エネルギーである場合に、上記導波管アセンブリによって放出される電界と平行に配設される、項目55に記載のエネルギー伝達アプリケータ。
(項目57)
上記マイクロ波エネルギーは、TE10モードで伝達される、項目55に記載のエネルギー伝達アプリケータ。
(項目58)
アンテナ開口と、冷却板とを備える、エネルギー伝達アプリケータを使用して、組織を冷却する方法であって、該冷却板は、近位面および遠位面を有し、かつ該エネルギー伝達アプリケータの遠位端に配置され、該アンテナ開口は、該冷却板の近位で該エネルギー伝達アプリケータ内に配置されており、該方法は、
該冷却板に隣接する該エネルギー伝達アプリケータの中に組織を係合するステップと、
該組織にエネルギーを適用するステップであって、該エネルギーは、該冷却板を通過する、ステップと、
該アンテナ開口と該冷却板の近位面との間に冷却液を通すステップと
から成る、方法。
(項目59)
組織に電磁エネルギーを分配する方法であって、該方法は、
アンテナ開口からエネルギーを放射するステップと、
冷却液を通してエネルギーを放射するステップであって、該冷却液は、該開口の下の冷却チャンバを通って流れる、ステップと、
該冷却チャンバ内に配置される散乱要素を越えてエネルギーを放射するステップと、
該開口の反対側に配置される冷却板を通してエネルギーを放射するステップと、
該冷却板の遠位側の組織生体障壁を通してエネルギーを放射するステップと
を含む、方法。
(項目60)
アンテナ配列にエネルギーを供給する方法であって、該方法は、
アプリケータ内に配置されるスイッチに電磁エネルギーを供給するステップであって、該スイッチは、1つ以上の導波管アンテナに接続される、ステップと、
所定の期間にわたって、該スイッチを通して第1の導波管アンテナに該電磁エネルギーを供給するステップと、
該アプリケータを配置し直すことなく、所定の期間にわたって、該スイッチを通して第2の導波管アンテナに該電磁エネルギーを供給するステップと
を含む、方法。
(項目61)
上記第1および上記第2の導波管アンテナは、相互に隣接する、項目60に記載のアンテナ配列にエネルギーを供給する方法。
(項目62)
アンテナ配列にエネルギーを供給する方法であって、
電力分割器を含むアプリケータに電磁エネルギーを供給するステップであって、該電力分割器は、1つ以上の導波管アンテナに接続される、ステップと、
該電力分割器を該1つ以上の導波管アンテナのうちの少なくとも2つに、連続的に接続するステップと、
該アプリケータを配置し直すことなく、所定の期間にわたって、単一のアンテナへの上記エネルギー供給を維持するステップと
を含む、方法。
(項目63)
医療デバイスのマイクロ波発生器で使用するためのマイクロ波チェーン制御回路であって、
該マイクロ波チェーンの出力に結合される、方向性結合器と、
該方向性結合器に結合される、電力検出器であって、該電力検出器は、順方向電力検出器と逆方向電力検出器とを備え、該電力検出器は、減衰器と検出器ダイオードとを備える、電力検出器と、
該順方向電力検出器に結合される、順方向電力参照テーブルであって、該順方向電力検出器の特性と相関があるデータを含む、順方向電力参照テーブルと、
該逆方向電力検出器に結合される、逆方向電力参照テーブルであって、該逆方向電力検出器の特性と相関があるデータを含む、逆方向電力参照テーブルと、
該順方向電力参照テーブルに結合される、負荷サイクル回路であって、該負荷サイクル回路は、該マイクロ波チェーンにおけるスイッチに結合され、該スイッチは、該マイクロ波チェーンにおける増幅器への入力信号の負荷サイクルを制御するように適合される、負荷サイクル回路と
を備える、マイクロ波チェーン制御回路。
(項目64)
医療デバイスのマイクロ波発生器におけるマイクロ波チェーンからの出力電力を制御する方法であって、該方法は、
該マイクロ波チェーンの出力において順方向電力信号を検出するステップと、
順方向電力参照テーブルに該順方向電力信号を投入するステップであって、該順方向電力参照テーブルは、該順方向電力検出器の電気特性に基づく相関データを含む、ステップと、
該相関データに従って該順方向電力信号を修正するステップと、
負荷サイクル回路に該修正した順方向電力信号を投入するステップであって、該負荷サイクル回路は、該マイクロ波チェーンにおける増幅器への入力信号の負荷サイクルを制御するように適合される、ステップと
を含む、方法。
(項目65)
中心支持材と、
約15度と約35度との間の第1の所定角度で、該中心支持材に接続される、第1および第2の腕支持材と
を備える、患者支持装置。
(項目66)
上記第1の所定角度は、約25度である、項目65に記載の患者支持装置。
(項目67)
可撓性透明基部を備える、治療テンプレートであって、
該可撓性透明基部は、
該基部上に印刷された、1つ以上の治療領域輪郭と、
該基部上に印刷された、複数の等間隔の麻酔注射部位と、
該基部上に印刷された、複数のテンプレート配置マークと、
該基部上に印刷された、複数のアプリケータ配置マークと
を備える、治療テンプレート。
(項目68)
上記1つ以上の治療領域輪郭は、項目67に記載の治療テンプレート。
(項目69)
患者の多汗症を治療する方法であって、該方法は、
患者支持装置上に該患者を配置するステップと、
該患者の腋窩上の目印に治療テンプレートを整列させるステップと、
該患者の腋窩上の麻酔注射部位に印を付けるステップと、
該患者の腋窩上のアプリケータ配置部位に印を付けるステップと、
アプリケータを該アプリケータ配置部位と整列させるステップと、
該患者の腋窩に冷却を適用するステップと、
該患者の腋窩にエネルギーを適用するステップと、
該アプリケータにおける複数のアンテナ介してエネルギーを切り替えるステップと、
該アプリケータを除去し、該整列マーキングを使用して、第2の治療部位に該アプリケータを移動させるステップと
を含む、方法。
Claims (8)
- マイクロ波エネルギーを放射するアプリケータ(2320)と一緒に使用するための使い捨て医療装置(2363)であって、該使い捨て医療装置(2363)は、
該使い捨て医療装置(2363)の遠位端に配置される組織チャンバ(2338)であって、該組織チャンバ(2338)は、その遠位端に配置された柔軟部材(2375)を含み、該柔軟部材(2375)は、皮膚と該組織チャンバ(2338)との間に密閉を提供する、組織チャンバ(2338)と、
該使い捨て装置(2363)の近位端におけるアプリケータチャンバ(2346)であって、該アプリケータチャンバ(2346)は、該アプリケータ(2320)を受容するように構成されている、アプリケータチャンバ(2346)と、
組織生体障壁(2337)を形成する可撓性フィルムであって、該組織生体障壁(2337)は、該組織チャンバ(2338)と該アプリケータチャンバ(2346)とを分離し、該組織生体障壁(2337)は、マイクロ波エネルギーに対して実質的に透明な誘電材料であり、空気および生体液に対して実質的に不透過性である、可撓性フィルムと、
該アプリケータチャンバ(2346)の近位端における真空シール(2348)であって、該真空シール(2348)は、アプリケータ(2320)が該アプリケータチャンバ(2346)内に配置されるときに、該アプリケータチャンバ(2346)を密閉するように配置される、真空シールと
を備え、
該アプリケータチャンバ(2346)は、真空通路(2333)およびアプリケータ生体障壁(2332)を介して該組織チャンバ(2338)と連通し、該アプリケータ生体障壁(2332)は、空気に対して実質的に透過性であるが、生体液に対して実質的に不透過性である、使い捨て医療装置(2363)。 - 前記組織生体障壁(2337)は、該組織生体障壁(2337)を通過するマイクロ波場を擾乱しない、請求項1に記載の使い捨て医療装置(2363)。
- 前記マイクロ波エネルギーが5GHz〜6.5GHzの周波数で放射される、請求項1に記載の使い捨て医療装置(2363)。
- 前記組織生体障壁(2337)が0.1GPaから1.5GPaの間のヤング係数を有する、請求項1に記載の使い捨て医療装置(2363)。
- 前記アプリケータ生体障壁(2332)が、真空回路(2341)中に配置されて、前記組織チャンバ(2338)内と前記アプリケータチャンバ(2346)内の真空圧の平衡を保つ、請求項1に記載の使い捨て医療装置(2363)。
- 前記組織生体障壁(2337)が0.001インチ(0.0254mm)未満の厚さである、請求項1に記載の使い捨て医療装置(2363)。
- 前記アプリケータ生体障壁(2332)は、膜フィルタを含む、請求項1に記載の使い捨て医療装置(2363)。
- 前記組織生体障壁(2337)の第1の面は、前記組織チャンバ(2338)内に組織界面(2336)を形成し、該組織生体障壁の第2の面は、前記アプリケータチャンバ(2346)のアプリケータ界面を形成する、請求項1に記載の使い捨て医療装置(2363)。
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KR20160106776A (ko) | 2016-09-12 |
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HK1148492A1 (en) | 2011-09-09 |
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ES2471971T3 (es) | 2014-06-27 |
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US8825176B2 (en) | 2014-09-02 |
US8406894B2 (en) | 2013-03-26 |
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