JP2022524092A - エネルギー送達のためのシステム及び方法 - Google Patents
エネルギー送達のためのシステム及び方法 Download PDFInfo
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- JP2022524092A JP2022524092A JP2021553060A JP2021553060A JP2022524092A JP 2022524092 A JP2022524092 A JP 2022524092A JP 2021553060 A JP2021553060 A JP 2021553060A JP 2021553060 A JP2021553060 A JP 2021553060A JP 2022524092 A JP2022524092 A JP 2022524092A
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Abstract
Description
(1) 内視鏡処置で使用するための可撓性シースであって、
前記可撓性シースは、a)近位端開口部を有する細長い管状体近位端及び遠位端開口部を有する細長い管状体遠位端と、b)細長い管状体内部部分及び細長い管状体外部部分と、を含む細長い管状体を備え、前記細長い管状体内部部分は、前記細長い管状体近位端から前記細長い管状体遠位端まで延在し、前記細長い管状体外部部分は、前記細長い管状体近位端から前記細長い管状体遠位端まで延在し、
前記細長い管状体内部部分は、前記近位端開口部に入り、前記細長い管状体近位端を通り、前記細長い管状体遠位端を通り、前記遠位端開口部の外へと延在する中空ポートを含み、前記中空ポートのサイズは、前記中空ポートに入り、前記中空ポートを通り、前記中空ポートから出る、適切なサイズのツールの通過に適合し得るようになっており、
前記可撓性シースの直径は5mm未満であり、
前記細長い管状体外部部分の前記遠位端は、1つ以上の高熱伝導領域又は1つ以上の可撓性-剛性領域を含み、
前記1つ以上の高熱伝導領域は、前記細長い管状体遠位端が組織領域に対して所望の位置で安定化されるように、前記組織領域との接触時に前記組織領域と選択的に固着するように構成されており、
前記1つ以上の高熱伝導領域の組織領域との固着時に、前記1つ以上の高熱伝導領域は、前記細長い管状体遠位端が前記組織領域に対して前記所望の位置から不安定化されるように、前記組織領域から選択的に分離するように構成されており、
前記1つ以上の可撓性-剛性領域は、可撓性状態と剛性状態とを選択的に交互に繰り返すように構成されており、
前記1つ以上の可撓性-剛性領域が剛性状態にある場合、前記細長い管状体遠位端は、前記可撓性-剛性領域と接触する組織領域に対して所望の位置で安定化され、
前記1つ以上の可撓性-剛性領域が可撓性状態にある場合、前記細長い管状体遠位端は、前記可撓性-剛性領域と接触する組織領域に対して安定化されない、可撓性シース。
(2) 前記細長い管状体内部部分は、細長い管状体の冷却剤取込チャネルと、細長い管状体遠位端収容領域と、細長い管状体の冷却剤排出チャネルと、を更に含み、
前記細長い管状体遠位端収容領域は、前記細長い管状体遠位端に位置付けられており、
前記細長い管状体内部部分は、a)前記細長い管状体の冷却剤取込チャネルを介して前記細長い管状体近位端内に冷却剤を受容し、b)前記細長い管状体の冷却剤取込チャネルを通して受容された前記冷却剤を前記細長い管状体遠位端収容領域へと循環させ、c)前記細長い管状体遠位端収容領域から前記細長い管状体の排出チャネルを通して前記細長い管状体近位端の外へと前記冷却剤を循環させるように構成されており、
前記細長い管状体の排出チャネルの直径は、前記細長い管状体の取込チャネルの直径よりも大きいか、又は
前記細長い管状体の排出チャネルの直径は、前記細長い管状体の取込チャネルの直径よりも小さいか、又は
前記細長い管状体の排出チャネルの直径及び前記細長い管状体の取込チャネルの直径は同一であり、
前記中空ポート、前記細長い管状体の取込チャネル、及び前記細長い管状体の排出チャネルは、多軸方式で位置付けられているか、又は
前記中空ポート、前記細長い管状体の取込チャネル、及び前記細長い管状体の排出チャネルは、同軸方式で同心円状に位置付けられており、
前記冷却剤は、水、グリコール、空気、不活性ガス、二酸化炭素、窒素、ヘリウム、六フッ化硫黄、イオン溶液(例えば、カリウム及び他のイオンを含むか又は含まない塩化ナトリウム)、水中デキストロース、乳酸リンゲル液、有機化学溶液(例えば、エチレングリコール、ジエチレングリコール、又はプロピレングリコール)、油(例えば、鉱物油、シリコーン油、フッ化炭素油)、液体金属、フレオン、ハロメタン、液化プロパン、他のハロアルカン、無水アンモニア、二酸化硫黄、及びその臨界点で又は臨界点付近で圧縮された冷却ガスから選択される、実施態様1に記載の可撓性シース。
(3) 前記1つ以上の高熱伝導領域は、組織領域に対する所望の位置で前記細長い管状体遠位端を安定化させるために、前記組織領域の凝固を引き起こす温度を達成し、維持して、前記組織領域の前記高熱伝導領域への固着を促進するように構成されており、
前記1つ以上の高熱伝導領域の前記温度は、前記細長い管状体収容領域の内外への冷却剤の循環によって調節され、
前記1つ以上の高熱伝導領域の前記温度は、前記細長い管状体収容領域の内外への冷却剤の循環によって、ジュールトムソン効果、吸熱化学反応、又は発熱化学反応を介して調節される、実施態様2に記載の可撓性シース。
(4) 前記1つ以上の高熱伝導領域は、金属、プラスチック、セラミック、又はこれらの混合物のうちの1つ以上を含み、
前記1つ以上の高熱伝導領域は可撓性である、実施態様3に記載の可撓性シース。
(5) 前記1つ以上の可撓性-剛性領域は、摂氏約15~25度の適切なガラス転移温度を有する熱可塑性ポリマーを含む、実施態様2に記載の可撓性シース。
前記熱可塑性ポリマーは、L-ラクチドとカプロラクトンとのコポリマー、例えば、L-ラクチド対カプロラクトンモノマー比が70:30以下であるポリ(L-ラクチド-co-カプロラクトン)を含む、実施態様5に記載の可撓性シース。
(7) 前記熱可塑性領域は、PURASORB(登録商標)PLC-7015として、オランダのホルクムにあるPurac Biomaterialsから市販されている、実施態様5に記載の可撓性シース。
(8) 前記1つ以上の可撓性-剛性領域の前記温度は、前記細長い管状体収容領域の内外への冷却剤の循環によって調節され、
摂氏約-40度での可撓性-剛性領域温度の維持は、前記1つ以上の可撓性-剛性領域の可撓性状態をもたらし、
摂氏約-5度での可撓性-剛性領域温度の維持は、前記1つ以上の可撓性-剛性領域の剛性状態をもたらし、
前記1つ以上の可撓性-剛性領域の前記温度は、前記細長い管状体収容領域の内外への冷却剤の循環によって、ジュールトムソン効果、吸熱化学反応、又は発熱化学反応を介して調節され、
前記細長い管状体内部領域は、ユーザーが任意の所望の方法で前記可撓性シースを操縦することを可能にするように構成された操縦可能なプルリングを更に含み、
前記可撓性シースは、マイクロ波場又はマイクロ波ゾーンに関連する損傷を被ることなく、マイクロ波場又はマイクロ波ゾーン内で動作可能であるように設計されており(例えば、前記可撓性シースはマイクロ波対応である)、
前記可撓性シースは、高温に関連する損傷を被ることなく、高温にさらされた組織領域内で動作可能であるように設計されている(例えば、前記可撓性シースは、熱抵抗性である)、実施態様5に記載の可撓性シース。
(9) 前記適切なサイズのツールは、栓子、アブレーションプローブ、エネルギー送達デバイス、生検ツールなどから選択され、
前記可撓性シースは、被験体を通って(例えば、枝分かれ構造を通って、気管支樹を通って、身体の任意の領域を通って所望の位置に到達するように)回り道の経路にアクセスするのに十分な可撓性を有し、
前記細長い管状体の組成物は、ポリマー材料であり、
前記細長い管状体の前記組成物は、より高い温度の定格ポリマー材料(higher temperature rated polymer material)、フッ素化エチレンプロピレン(FEP)、熱可塑性コポリエステル(例えば、Arnitel)、及びフルオロポリマー(例えば、アルカン(MFA)又はペルフルオロアルコキシアルカン(PFA))から選択される、実施態様1に記載の可撓性シース。
(10) 一次カテーテルと、実施態様1に記載の可撓性シースと、エネルギー送達デバイスと、を備えるシステム。
(12) 前記エネルギー送達デバイスはマイクロ波エネルギー送達デバイスである、実施態様10に記載のシステム。
(13) 組織領域を治療する方法であって、実施態様10に記載のシステムを提供することと、前記一次カテーテルを組織領域に挿入することと、前記一次カテーテルを通して治療されるべき所望の組織領域に前記可撓性シースを挿入することと、前記1つ以上の高熱伝導領域又は前記1つ以上の可撓性-剛性領域のいずれかを介して、前記治療されるべき所望の組織領域に前記可撓性シースを固定することと、前記可撓性シースを通して前記治療されるべき所望の組織領域に前記エネルギー送達デバイスを挿入することと、前記治療されるべき組織領域を前記エネルギー送達デバイスで治療することと、を含む、方法。
(14) 前記治療されるべき組織領域は被験体内にある、実施態様13に記載の方法。
(15) 前記被験体はヒト被験体である、実施態様14に記載の方法。
Claims (12)
- 内視鏡処置で使用するための可撓性シースであって、
前記可撓性シースは、a)近位端開口部を有する細長い管状体近位端及び遠位端開口部を有する細長い管状体遠位端と、b)細長い管状体内部部分及び細長い管状体外部部分と、を含む細長い管状体を備え、前記細長い管状体内部部分は、前記細長い管状体近位端から前記細長い管状体遠位端まで延在し、前記細長い管状体外部部分は、前記細長い管状体近位端から前記細長い管状体遠位端まで延在し、
前記細長い管状体内部部分は、前記近位端開口部に入り、前記細長い管状体近位端を通り、前記細長い管状体遠位端を通り、前記遠位端開口部の外へと延在する中空ポートを含み、前記中空ポートのサイズは、前記中空ポートに入り、前記中空ポートを通り、前記中空ポートから出る、適切なサイズのツールの通過に適合し得るようになっており、
前記可撓性シースの直径は5mm未満であり、
前記細長い管状体外部部分の前記遠位端は、1つ以上の高熱伝導領域又は1つ以上の可撓性-剛性領域を含み、
前記1つ以上の高熱伝導領域は、前記細長い管状体遠位端が組織領域に対して所望の位置で安定化されるように、前記組織領域との接触時に前記組織領域と選択的に固着するように構成されており、
前記1つ以上の高熱伝導領域の組織領域との固着時に、前記1つ以上の高熱伝導領域は、前記細長い管状体遠位端が前記組織領域に対して前記所望の位置から不安定化されるように、前記組織領域から選択的に分離するように構成されており、
前記1つ以上の可撓性-剛性領域は、可撓性状態と剛性状態とを選択的に交互に繰り返すように構成されており、
前記1つ以上の可撓性-剛性領域が剛性状態にある場合、前記細長い管状体遠位端は、前記可撓性-剛性領域と接触する組織領域に対して所望の位置で安定化され、
前記1つ以上の可撓性-剛性領域が可撓性状態にある場合、前記細長い管状体遠位端は、前記可撓性-剛性領域と接触する組織領域に対して安定化されない、可撓性シース。 - 前記細長い管状体内部部分は、細長い管状体の冷却剤取込チャネルと、細長い管状体遠位端収容領域と、細長い管状体の冷却剤排出チャネルと、を更に含み、
前記細長い管状体遠位端収容領域は、前記細長い管状体遠位端に位置付けられており、
前記細長い管状体内部部分は、a)前記細長い管状体の冷却剤取込チャネルを介して前記細長い管状体近位端内に冷却剤を受容し、b)前記細長い管状体の冷却剤取込チャネルを通して受容された前記冷却剤を前記細長い管状体遠位端収容領域へと循環させ、c)前記細長い管状体遠位端収容領域から前記細長い管状体の排出チャネルを通して前記細長い管状体近位端の外へと前記冷却剤を循環させるように構成されており、
前記細長い管状体の排出チャネルの直径は、前記細長い管状体の取込チャネルの直径よりも大きいか、又は
前記細長い管状体の排出チャネルの直径は、前記細長い管状体の取込チャネルの直径よりも小さいか、又は
前記細長い管状体の排出チャネルの直径及び前記細長い管状体の取込チャネルの直径は同一であり、
前記中空ポート、前記細長い管状体の取込チャネル、及び前記細長い管状体の排出チャネルは、多軸方式で位置付けられているか、又は
前記中空ポート、前記細長い管状体の取込チャネル、及び前記細長い管状体の排出チャネルは、同軸方式で同心円状に位置付けられており、
前記冷却剤は、水、グリコール、空気、不活性ガス、二酸化炭素、窒素、ヘリウム、六フッ化硫黄、イオン溶液(例えば、カリウム及び他のイオンを含むか又は含まない塩化ナトリウム)、水中デキストロース、乳酸リンゲル液、有機化学溶液(例えば、エチレングリコール、ジエチレングリコール、又はプロピレングリコール)、油(例えば、鉱物油、シリコーン油、フッ化炭素油)、液体金属、フレオン、ハロメタン、液化プロパン、他のハロアルカン、無水アンモニア、二酸化硫黄、及びその臨界点で又は臨界点付近で圧縮された冷却ガスから選択される、請求項1に記載の可撓性シース。 - 前記1つ以上の高熱伝導領域は、組織領域に対する所望の位置で前記細長い管状体遠位端を安定化させるために、前記組織領域の凝固を引き起こす温度を達成し、維持して、前記組織領域の前記高熱伝導領域への固着を促進するように構成されており、
前記1つ以上の高熱伝導領域の前記温度は、前記細長い管状体収容領域の内外への冷却剤の循環によって調節され、
前記1つ以上の高熱伝導領域の前記温度は、前記細長い管状体収容領域の内外への冷却剤の循環によって、ジュールトムソン効果、吸熱化学反応、又は発熱化学反応を介して調節される、請求項2に記載の可撓性シース。 - 前記1つ以上の高熱伝導領域は、金属、プラスチック、セラミック、又はこれらの混合物のうちの1つ以上を含み、
前記1つ以上の高熱伝導領域は可撓性である、請求項3に記載の可撓性シース。 - 前記1つ以上の可撓性-剛性領域は、摂氏約15~25度の適切なガラス転移温度を有する熱可塑性ポリマーを含む、請求項2に記載の可撓性シース。
- 前記熱可塑性ポリマーは、乳酸とカプロラクトンとのコポリマーを含み、
前記熱可塑性ポリマーは、L-ラクチドとカプロラクトンとのコポリマー、例えば、L-ラクチド対カプロラクトンモノマー比が70:30以下であるポリ(L-ラクチド-co-カプロラクトン)を含む、請求項5に記載の可撓性シース。 - 前記熱可塑性領域は、PURASORB(登録商標)PLC-7015として、オランダのホルクムにあるPurac Biomaterialsから市販されている、請求項5に記載の可撓性シース。
- 前記1つ以上の可撓性-剛性領域の前記温度は、前記細長い管状体収容領域の内外への冷却剤の循環によって調節され、
摂氏約-40度での可撓性-剛性領域温度の維持は、前記1つ以上の可撓性-剛性領域の可撓性状態をもたらし、
摂氏約-5度での可撓性-剛性領域温度の維持は、前記1つ以上の可撓性-剛性領域の剛性状態をもたらし、
前記1つ以上の可撓性-剛性領域の前記温度は、前記細長い管状体収容領域の内外への冷却剤の循環によって、ジュールトムソン効果、吸熱化学反応、又は発熱化学反応を介して調節され、
前記細長い管状体内部領域は、ユーザーが任意の所望の方法で前記可撓性シースを操縦することを可能にするように構成された操縦可能なプルリングを更に含み、
前記可撓性シースは、マイクロ波場又はマイクロ波ゾーンに関連する損傷を被ることなく、マイクロ波場又はマイクロ波ゾーン内で動作可能であるように設計されており(例えば、前記可撓性シースはマイクロ波対応である)、
前記可撓性シースは、高温に関連する損傷を被ることなく、高温にさらされた組織領域内で動作可能であるように設計されている(例えば、前記可撓性シースは、熱抵抗性である)、請求項5に記載の可撓性シース。 - 前記適切なサイズのツールは、栓子、アブレーションプローブ、エネルギー送達デバイス、生検ツールなどから選択され、
前記可撓性シースは、被験体を通って(例えば、枝分かれ構造を通って、気管支樹を通って、身体の任意の領域を通って所望の位置に到達するように)回り道の経路にアクセスするのに十分な可撓性を有し、
前記細長い管状体の組成物は、ポリマー材料であり、
前記細長い管状体の前記組成物は、より高い温度の定格ポリマー材料、フッ素化エチレンプロピレン(FEP)、熱可塑性コポリエステル(例えば、Arnitel)、及びフルオロポリマー(例えば、アルカン(MFA)又はペルフルオロアルコキシアルカン(PFA))から選択される、請求項1に記載の可撓性シース。 - 一次カテーテルと、請求項1に記載の可撓性シースと、エネルギー送達デバイスと、を備えるシステム。
- 前記一次カテーテルは内視鏡である、請求項10に記載のシステム。
- 前記エネルギー送達デバイスはマイクロ波エネルギー送達デバイスである、請求項10に記載のシステム。
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CN113543691A (zh) | 2021-10-22 |
EP3934505A1 (en) | 2022-01-12 |
BR112021017600A2 (pt) | 2021-11-16 |
US11832879B2 (en) | 2023-12-05 |
WO2020183262A1 (en) | 2020-09-17 |
CN113543691B (zh) | 2024-02-13 |
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