JP2013517011A - 自己組織化モジュール式経皮弁並びに折畳み、組立て、及び送達の方法 - Google Patents
自己組織化モジュール式経皮弁並びに折畳み、組立て、及び送達の方法 Download PDFInfo
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Abstract
Description
Claims (26)
- 複数のデバイスモジュール及び自己組織化部材を含むモジュール式人工弁デバイスであって、前記デバイスモジュールが、前記自己組織化部材により前記弁デバイスが必要な体内において前記弁デバイスへと組み立てられるように設計されるモジュール式人工弁デバイス。
- 複数のデバイスモジュールが、複数の弁セクションを含み、前記弁セクションがそれぞれ、第1の端部、第2の端部、基部、及び先端部を有し、前記複数の弁セクションが、組み立てられていない状態においては、端部同士を接続した状態で連続的に構成され、自己組織化部材により作動構成へと組み立て可能であり、前記一連の弁セクションが、円周軸及び高さ軸を有し、前記円周軸が、前記一連の中の第1の弁セクションの第1の端部から前記一連の中の最終の弁セクションの第2の端部まで延在し、前記高さ軸が、前記弁セクションの基部−先端部アスペクトによって規定され、前記自己組織化部材が、前記円周軸に沿って取り付けられる、請求項1に記載のデバイス。
- 複数のデバイスモジュールが、弁構成要素を含み、前記弁構成要素が、組み立てられていない状態においては、第1の端部、第2の端部、基部−先端部アスペクト、円周軸、及び高さ軸を有する実質的に平坦な弁尖下位構造体を含み、前記円周軸が、前記第1の端部と前記第2の端部との間に延在し、前記高さ軸が、前記組み立てられていない弁尖下位構造体の前記基部−先端部アスペクトによって規定され、自己組織化部材が、前記円周軸に沿って取り付けられる、請求項1に記載のデバイス。
- 複数のデバイスモジュールが、支持構造体をさらに含む、請求項2又は3に記載のデバイス。
- 自己組織化部材が、第1の自己組織化部材であり、デバイスが、第2の自己組織化部材をさらに含む、請求項4に記載のデバイス。
- 自己組織化部材が、形状記憶合金を含む、請求項1に記載のデバイス。
- 第2の自己組織化部材が、形状記憶合金を含む、請求項5に記載のデバイス。
- 単一軸に沿って送達構成へと巻かれた弁モジュールを含むモジュール式経皮弁デバイス。
- 送達デバイス内に設置するための、及び送達後に組立てのために開くことが可能な、折り畳まれた弁モジュールを含み、前記折り畳まれた弁モジュールが、開かれ実質的に平坦な組み立てられていない状態においては、第1の軸及び第2の軸を有し、前記折り畳まれた構成が、前記第2の軸の方向に前記第1の軸に沿って巻かれた状態を含む、モジュール式経皮弁デバイス。
- 第1の軸が、円周軸であり、第2の軸が、高さ軸である、請求項9に記載のデバイス。
- 第1の軸が、高さ軸であり、第2の軸が、円周軸である、請求項9に記載のデバイス。
- 折り畳まれた弁モジュールが、弁構成要素へと組み立てられ得る弁尖下位構造体を含み、弁デバイスが、
送達デバイス内に設置するために圧縮される拡張可能支持構造体であって、前記弁デバイスが、前記組み立てられた弁構成要素及び拡張された状態にある前記支持構造体から組み立てられ得る、拡張可能支持構造体
をさらに含む、請求項9に記載のデバイス。 - 開かれ実質的に平坦な組み立てられていない弁モジュールが、一連の複数の弁セクションを含み、前記複数の弁セクションが、弁アセンブリへと組み立て可能であり、前記弁セクションがそれぞれ、セクション高さ軸及びセクション円周軸を有し、第1の軸が、前記セクション円周軸の和を含む円周軸であり、第2の軸が、各前記セクション高さ軸に相当する高さ軸である、請求項9に記載のモジュール式経皮弁デバイス。
- 開かれ実質的に平坦な組み立てられていない弁モジュールが、一連の複数の弁セクションを含み、前記複数の弁セクションが、弁アセンブリへと組み立て可能であり、前記弁セクションがそれぞれ、セクション高さ軸及びセクション円周軸を有し、第1の軸が、各前記セクション高さ軸に相当する高さ軸であり、第2の軸が、前記セクション円周軸の和を含む円周軸である、請求項9に記載のモジュール式経皮弁デバイス。
- 実質的に平坦な組み立てられていない状態において、高さ軸及び円周軸を有する弁モジュールであって、送達デバイス内において送達のために折り畳まれ、前記折り畳まれた構成が、前記高さ軸の方向に前記円周軸に沿って巻かれていることを含み、前記折り畳まれた弁モジュールが、前記送達デバイスからの展開後に組み立てられた弁モジュールを形成することが可能である、弁モジュールと、
自己組織化部材と、
前記送達デバイス内において送達のために圧縮され、前記送達デバイスからの展開後に組立て及び移植のために拡張され得る、拡張可能支持構造体と
を含み、
前記拡張された支持構造体及び前記組み立てられた弁モジュールから組み立てられ得る、モジュール式経皮弁デバイス。 - 人工弁デバイスが必要な体内において前記人工弁デバイスを組み立てるためのシステムであって、送達デバイス及び請求項1又は17に記載の弁デバイスを含む、システム。
- 誘導ストリングをさらに含む、請求項18に記載のシステム。
- プッシュ−ロッドをさらに含む、請求項18に記載のシステム。
- 経皮送達デバイス内において送達するためにモジュール式弁デバイスを折り畳む方法であって、
第1の軸及び第2の軸を有する実質的に平坦な組み立てられていない弁モジュールを含む弁デバイスを用意するステップと、
前記送達デバイス内に装填する前に、前記第2の軸の方向に前記第1の軸に沿って前記組み立てられていない弁モジュールを巻くステップと
を含む、方法。 - 第1の軸が、円周軸であり、第2の軸が、高さ軸である、請求項19に記載の方法。
- モジュール式人工弁デバイスの弁モジュールを組み立てるための自己組織化部材であって、送達構成及び事前設定構成を有し、前記事前設定構成においてはリング構造体を含む、自己組織化部材。
- 事前設定構成においては、リング構造体に対して垂直に配向されたマストをさらに含む、請求項21に記載の自己組織化部材。
- 第1の自己組織化部材及び第2の自己組織化部材を含み、前記第1の自己組織化部材が、事前設定構成においてはリング構造体を含み、前記第2の自己組織化部材が、前記事前設定構成においては前記リング構造体に対して垂直に配向されたポストを含む、請求項21に記載の自己組織化部材。
- 弁モジュール及び自己組織化部材を収容する送達デバイスを用意するステップであって、前記弁モジュールが、組み立てられていない形態にあり、前記自己組織化部材が、送達構成の状態にあり、前記弁モジュールに対して取り付けられる、ステップと、
前記送達デバイスから前記組み立てられていない弁モジュールを展開するステップと、
前記自己組織化部材を作動させて、事前設定構成に復帰させるステップと、
前記自己組織化部材を使用して前記弁モジュールを組み立てるステップと
を含む、
モジュール式弁デバイスを組み立てる方法。 - 組み立てられていない弁モジュールが、第1の端部及び第2の端部を有する弁尖下位構造体であり、前記弁モジュールが、ロッキング機構をさらに含み、
前記ロッキング機構により前記第1の端部及び前記第2の端部を合体させるステップ
をさらに含む、請求項24に記載の方法。 - モジュール式人工弁デバイスが必要な体内において前記モジュール式人工弁デバイスを組み立てる方法であって、
複数のデバイスモジュール及び自己組織化部材を収容する送達デバイスを用意するステップであって、前記自己組織化部材が、送達構成の状態にあり、前記複数のデバイスモジュールが、非拡張構成に圧縮された拡張可能支持構造体と、折り畳まれた構成にある弁尖下位構造体とを含み、前記弁尖下位構造体が、組み立てられていない開かれた実質的に平坦な構成に広げられた場合に、高さ軸及び円周軸を有し、前記自己組織化部材が、前記弁尖下位構造体円周軸に取り付けられ、前記弁尖下位構造体の前記折り畳まれた構成が、前記送達デバイス内への装填前に前記高さ軸の方向に前記円周軸に沿って巻かれていることを含む、ステップと、
前記送達デバイスから前記非拡張支持構造体及び前記折り畳まれた弁尖下位構造体を展開するステップと、
前記支持構造体を拡張させるステップと、
前記折り畳まれた弁尖下位構造体を開き、前記自己組織化部材を作動させて事前設定構成に復帰させるステップと、
前記自己組織化部材を使用して前記弁尖下位構造体を組み立てて弁構成要素を形成するステップと、
前記弁構成要素及び前記支持構造体を組み合わせて、組み立てられた弁デバイスを形成するステップと
を含む方法。
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