JP7300489B2 - 吻合を形成するためのステントを含む医療用具 - Google Patents
吻合を形成するためのステントを含む医療用具 Download PDFInfo
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Description
いくつかの医療手技は隣接した体管腔の間の吻合の形成を必要とする。例えば、いくつかの手技は、第1の器官又は構造物、例えば食道、胃、十二指腸、小腸、大腸、又は腹膜腔を通して胃腸(GI)管に進入すること、並びに、アンカー又はステントを、隣接した器官及び管腔構造物又は組織構造物、例えばGI管、胆管、膵管、胆嚢、膵臓、嚢胞、偽嚢胞、膿瘍などの隣接した部分に送達することによって実施されうる。そのような方法及び装置は、膀胱及び尿管のような尿路、気管及び気管支のような肺系の管、並びに胆管及び胆嚢のような胆道の部分どうしの間の行き来(アクセス)にも、また同様に脈管への適用にも使用可能である。
本明細書中に開示された実施形態のうち任意のものにおいて、ステントは自己拡張型ステントである。
本明細書中に開示された実施形態のうち任意のものにおいて、医療用具は、可撓性材料を解くこと(opening)によりステントの第1端を制御可能に解放するように構成された第1のプルワイヤアセンブリ、及び可撓性材料を解くことによりステントの第2端を拘束している材料を制御可能に解放するように構成された第2のプルワイヤアセンブリを備えることが可能である。
本明細書中に開示された実施形態のうち任意のものにおいて、医療用具は、身体組織を貫通するように構成された、先鋭化した先端部位を備えることができる。
本明細書中に開示された実施形態のうち任意のものにおいて、腸管内の標的位置は十二指腸である。
本明細書中に開示された実施形態のうち任意のものにおいて、空腸又は回腸の中にステントの第1端を留置した後、空腸又は回腸の中にステントの第1端を留置した後のシースの抜去を休止することと、空腸又は回腸内部の第1端の留置を確認することとをさらに含んでなる。本明細書中に開示された実施形態のうち任意のものにおいて、空腸又は回腸内部のステントの第1端の留置を確認した後に、胃の内部にステントの第2端を留置するためにシースの抜去を再開すること(continuing)。
本明細書中に開示された実施形態のうち任意のものにおいて、ステントを担持しているカテーテルデバイスとともに患者の底部嚢に内視鏡で到達する前に、腹腔鏡で腹膜腔に到達すること;腹膜腔内に腹腔鏡用の環境を作出すること;及び腹膜腔に手動器具を導入することをさらに含んでなる。本明細書中に開示された実施形態のうち任意のものにおいて、方法は、手動器具を使用して腹膜腔の中へカテーテルデバイスのチップを誘導すること、及び、手動器具を使用して腹膜腔を通して空腸の外側の標的位置へカテーテルデバイスのチップを誘導することをさらに含んでなる。本明細書中に開示された実施形態のうち任意のものにおいて、方法は、空腸壁を貫通する前に腹膜腔内の第2の手動器具を用いて空腸を空腸内の標的位置に隣接して保持することをさらに含んでなる。本明細書中に開示された実施形態のうち任意のものにおいて、方法は、腹腔鏡の誘導を使用して、底部嚢、カテーテルデバイスのチップ、及び空腸内の標的位置を腹膜から視覚化することをさらに含んでなる。
本明細書中に開示された実施形態のうち任意のものにおいて、該方法は、胃バイパス手技の際に底部嚢を形成すること、及び底部嚢を腸管に接続して底部嚢と腸管との間に通路を形成することをさらに含んでなる。
本明細書中に開示された実施形態のうち任意のものにおいて、ステントの留置は、ステントの第1端を腸管内部に留置すること及びステントの第2端を底部嚢内に留置することをさらに含んでなる。
本明細書中に開示された実施形態のうち任意のものにおいて、方法は、腹膜腔に到達した後及び底部嚢の壁を貫通する前に、ステントを保持しているステント保持具の、腹腔鏡デバイスのシャフトに対する配向を、シャフトによって規定された軸平面に沿った第1の配向から第2の配向へと、シャフトによって規定された軸平面に対して回転させることをさらに含んでなる。
本明細書中に開示された実施形態のうち任意のものにおいて、吻合デバイスはステントである。本明細書中に開示された実施形態のうち任意のものにおいて、ステントの第1端の留置は、ステントの第1端を腸管の第1の内部空間内に留置した後に、ステントの第1端を第1の腸管壁に係合し、かつ第1の腸管壁を第2の腸管壁の貫通部の近くに移動させるために、ステントの二重壁フランジ構造物上の牽引部を引くことをさらに含んでなる。
患者の消化管に吻合を形成する方法が本明細書中に開示される。方法は、ステントを担持しているカテーテルデバイスを用いて腸管の第1の部分に到達すること、カテーテルデバイスを用いて腸管の第1の閉端部に隣接した腸管の第1の部分の壁を貫通すること、カテーテルデバイスを用いて腸管の第2の閉端部に隣接した腸管の第2の部分の壁を貫通すること、ステントの第1端を、腸管の第2の部分の壁に係合するように留置すること、及び、ステントの第2端を、腸管の第1の部分の壁に係合するように留置することによって、腸管の第1の部分と腸管の第2の部分との間に経路を形成することを含む。
本明細書中に開示された実施形態のうち任意のものにおいて、カテーテルデバイスを用いた腸管の第1の部分への到達は、カテーテルデバイスを用いて腹膜腔に到達すること、腸管の第1の部分に貫通部を形成すること、及び腸管の第1の部分の内部空間内へカテーテルを前進させることをさらに含んでなる。
いくつかの実施形態では、本明細書中に開示されたデバイスは体管腔を通る通路を促進するために可撓性であることができる。例えば、本明細書中に開示されたカテーテルを用いるデバイスは、内視鏡と共に使用されるように可撓性であってよい。
図16Hは、円筒形の中央領域161から離れるように巻いている巻き込み型の端部163と共に直角に近い複数の屈曲部を有しているステントフランジ162を例証している。直角は、ステントの側方強度及び引抜力を高めることが可能である。
製造技術の例には、レーザー切断、製織、溶接、エッチング、及びワイヤ成形を使用することが挙げられる。シリコンのようなメンブレン材料は、ステント壁を通る流体の通行を防止するためにワイヤステントフレームに適用可能である。メンブレン材料は、塗装、刷毛塗り、噴霧、浸漬、又はモールド成形によって適用可能である。
[付記1]
ステントであって、
拘束された形態を有する製織フィラメント編組物で形成されたステント本体を含んでなり、前記ステント本体は、拡張されて基端側フランジをなした前記本体の基端、拡張されて先端側フランジをなした前記本体の先端、及び前記基端側フランジと前記先端側フランジとの間に延びる円筒形領域を備えた拡張形態を有し、少なくとも前記円筒形領域にはカバーが付されており、
カバー付きの円筒形領域は、同カバー付きの円筒形領域を貫通して流れることを可能にするように構成された、通行可能な内部通路を有し、
前記基端側フランジ及び前記先端側フランジは、同基端側フランジ及び同先端側フランジを貫通して流れることを可能にするように構成されており、
前記基端側フランジ及び前記先端側フランジは、同基端側フランジと同先端側フランジとの間の身体組織を傷つけることなく同身体組織の隣接する層を並置するように構成されており、前記基端側フランジは前記ステントの前記通行可能な内部通路に向かって巻いている巻き込み型の壁を備え、前記先端側フランジは前記ステントの前記通行可能な内部通路に向かって巻いている巻き込み型の壁を備えている、ステント。
ステントであって、
拘束された形態を有する製織フィラメント編組物で形成されたステント本体を含んでなり、前記ステント本体は、拡張されて基端側フランジをなした前記本体の基端、拡張されて先端側フランジをなした前記本体の先端、及び前記基端側フランジと前記先端側フランジとの間に延びる円筒形領域を備えた拡張形態を有し、少なくとも前記円筒形領域にはカバーが付されており、
カバー付きの円筒形領域は、同カバー付きの円筒形領域を貫通して流れることを可能にするように構成された、通行可能な内部通路を有し、
前記基端側フランジ及び前記先端側フランジは、同基端側フランジ及び同先端側フランジを貫通して流れることを可能にするように構成されており、
前記基端側フランジ及び前記先端側フランジは、同基端側フランジと同先端側フランジとの間の身体組織を傷つけることなく同身体組織の隣接する層を並置するように構成されており、前記基端側フランジは前記カバー付きの円筒形領域を覆うように屈曲するように構成されており、前記先端側フランジは前記カバー付きの円筒形領域を覆うように屈曲するように構成されている、ステント。
前記基端側フランジは前記カバー付きの円筒形領域の前記通行可能な内部通路に向かって巻いている巻き込み型の壁を備え、前記先端側フランジは前記カバー付きの円筒形領域の前記通行可能な内部通路に向かって巻いている巻き込み型の壁を備えている、付記2に記載のステント。
前記基端側フランジは、傷つけることなく身体組織に係合するように構成された同基端側フランジの基端に隣接する湾曲面をさらに含んでなり、かつ前記先端側フランジは傷つけることなく身体組織に係合するように構成された同先端側フランジの先端に隣接する湾曲面をさらに含んでなる、付記1~3のいずれか一項に記載のステント。
前記基端側フランジは前記カバー付きの円筒形領域の直径より大きな内径を有し、前記先端側フランジは前記カバー付きの円筒形領域の直径より大きな内径を有する、付記1または付記2に記載のステント。
前記ステントは自己拡張型ステントである、付記1または付記2に記載のステント。
[付記7]
自己拡張型のステントであって、
非拡張形態及び拡張形態を有する可撓性の本体を含んでなり、拡張形態は、拡張されて基端側フランジをなした前記本体の基端部、拡張されて先端側フランジをなした前記本体の先端部、及び前記基端側フランジと前記先端側フランジとの間の円筒形領域を備え、少なくとも前記円筒形領域にはカバーが付されており、
カバー付きの円筒形領域は、同カバー付きの円筒形領域を貫通して流れることを可能にするように構成された、通行可能な内部通路を有し、
前記基端側フランジ及び前記先端側フランジはそれぞれ、同基端側フランジ及び同先端側フランジを貫通して流れることを可能にするように前記円筒形領域の前記内部通路から離れるように突出しており、
前記基端側フランジ及び前記先端側フランジは、同基端側フランジと同先端側フランジとの間の身体組織を傷つけることなく同身体組織の隣接する層を並置するように構成されており、前記基端側フランジは前記カバー付きの円筒形領域を覆うように屈曲するように構成され、前記先端側フランジは前記カバー付きの円筒形領域を覆うように屈曲するように構成されている、ステント。
前記基端側フランジは前記カバー付きの円筒形領域の前記通行可能な内部通路に向かって巻いている巻き込み型の壁を備え、前記先端側フランジは前記カバー付きの円筒形領域の前記通行可能な内部通路に向かって巻いている巻き込み型の壁を備えている、付記7に記載のステント。
前記基端側フランジは、傷つけることなく身体組織に係合するように構成された同基端側フランジの基端に隣接する湾曲面をさらに含んでなり、かつ前記先端側フランジは傷つけることなく身体組織に係合するように構成された同先端側フランジの先端に隣接する湾曲面をさらに含んでなる、付記7または付記8に記載のステント。
前記基端側フランジは前記カバー付きの円筒形領域の直径より大きな内径を有し、前記先端側フランジは前記カバー付きの円筒形領域の直径より大きな内径を有する、付記7に記載のステント。
前記ステントは自己拡張型ステントである、付記7に記載のステント。
[付記12]
医療用具であって、
ハンドル、
ハンドルに係合したシャフト、
ステントであって、
拘束された形態を有する製織フィラメント編組物で形成されたステント本体を含んでなり、前記ステント本体は、拡張されて基端側フランジをなした前記本体の基端、拡張されて先端側フランジをなした前記本体の先端、及び前記基端側フランジと前記先端側フランジとの間に延びる円筒形領域を備えた拡張形態を有し、少なくとも前記円筒形領域にはカバーが付されており、
カバー付きの円筒形領域は、同カバー付きの円筒形領域を貫通して流れることを可能にするように構成された、通行可能な内部通路を有し、
前記基端側フランジ及び前記先端側フランジは、同基端側フランジ及び同先端側フランジを貫通して流れることを可能にするように構成されており、
前記基端側フランジ及び前記先端側フランジは、同基端側フランジと同先端側フランジとの間の身体組織を傷つけることなく同身体組織の隣接する層を並置するように構成されている、ステント、及び
前記ステントを拘束された状態に保持するように構成されたステント保持具、を含んでなり、
前記ステント保持具は、前記ステントを拘束する材料であって、拘束された状態に前記ステントを保持するように構成され、かつ前記ステントを解いて拡張するように構成された材料を備えている、医療用具。
前記ステント保持具は前記ステントの前記先端側フランジ及び前記基端側フランジを選択的に解放するように構成されている、付記12に記載の医療用具。
身体組織を貫通するように構成された先鋭化した先端部位をさらに含む、付記12に記載の医療用具。
身体組織を貫通するように構成された伝導性の要素を前記シャフトの先端部にさらに含む、付記12に記載の医療用具。
Claims (10)
- 腹腔鏡下での使用のために構成された医療用具であって、
ハンドルと、
前記ハンドルに係合したシャフトと、
自己拡張型のステントと、
前記自己拡張型のステントを拘束された状態に保持するように構成されたステント保持具と、
前記シャフトに対する前記ステント保持具の配向を、前記シャフトによって規定された軸平面に沿った第1の配向から、前記シャフトによって規定された前記軸平面への第2の配向へと変化させるように構成された関節要素と、
を備え、
前記ステント保持具は、前記自己拡張型のステントを拘束する材料であって、前記拘束された状態に前記ステントを保持するように構成され、前記ステントが拡張するのを可能にするべく解けるように構成され、かつステントの留置後に除去可能であるように構成された材料を備える、医療用具。 - 前記ステント保持具は前記ステントの第1端及び前記ステントの第2端を選択的に解放するように構成されている、請求項1に記載の医療用具。
- 可撓性材料を解くことにより前記ステントの前記第1端を制御可能に解放するように構成された第1のプルワイヤアセンブリ、及び前記可撓性材料を解くことにより前記ステントの前記第2端を拘束している材料を制御可能に解放するように構成された第2のプルワイヤアセンブリをさらに備える、請求項2に記載の医療用具。
- 前記ステント保持具及び前記自己拡張型のステントは着脱可能なカートリッジアセンブリの一部である、請求項1に記載の医療用具。
- 身体組織を貫通するように構成された、先鋭化した先端部位をさらに備える、請求項1に記載の医療用具。
- 腹腔鏡下での使用のために構成された医療用具であって、前記医療用具は、
ハンドルと、
前記ハンドルに係合したシャフトと、
自己拡張型のステントを拘束された状態に保持するように構成されたステント保持具と、
を備え、
前記ステント保持具は、前記自己拡張型のステントを拘束する材料であって、前記拘束された状態に前記ステントを保持するように構成され、前記ステントが拡張するのを可能にするべく解けるように構成され、かつステントの留置後に除去可能であるように構成された材料を備え、前記ステント保持具は前記ステントの第1端及び前記ステントの第2端を選択的に解放するように構成されている、医療用具。 - 前記シャフトに対する前記ステント保持具の配向を、前記シャフトによって規定された軸平面に沿った第1の配向から、前記シャフトによって規定された前記軸平面への第2の配向へと変化させるように構成された関節要素をさらに備える、請求項6に記載の医療用具。
- 可撓性材料を解くことにより前記ステントの前記第1端を制御可能に解放するように構成された第1のプルワイヤアセンブリ、及び前記可撓性材料を解くことにより前記ステントの前記第2端を拘束している材料を制御可能に解放するように構成された第2のプルワイヤアセンブリをさらに備える、請求項6に記載の医療用具。
- 前記ステント保持具及び前記自己拡張型のステントは着脱可能なカートリッジアセンブリの一部である、請求項6に記載の医療用具。
- 身体組織を貫通するように構成された、先鋭化した先端部位をさらに備える、請求項6に記載の医療用具。
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