JP2022130372A - 組織取り出しシステムおよび方法 - Google Patents
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Abstract
Description
本願は、2015年4月23日に出願された米国特許仮出願第62/151,736号(発明の名称:Systems and methods for tissue removal)の優先権および権益主張出願である。
Claims (26)
- 組織の辺縁を保護するために体開口部を通る耐切断性経路を提供するガードであって、前記ガードは、
中央ルーメンを画定する管の形状を備えた側壁を有し、前記中央ルーメンは、近位端部のところの近位開口部と遠位端部のところの遠位開口部との間で長手方向軸線に沿って延び、前記側壁は、隙間を形成する複数の織編フィラメントを有する柔軟性の耐切断性メッシュ材料の少なくとも1つの層で作られ、前記側壁は、前記近位端部に向かって次第に拡径している前記中央ルーメンが前記側壁に近位フランジを形成し、前記遠位端部に向かって次第に拡径している前記中央ルーメンが前記側壁に遠位フランジを形成する常態の非変形形態にあるときに全体として砂時計の形状を有し、前記近位フランジは、前記ガードを前記組織辺縁の近位端部に対して定着させるよう構成され、前記遠位フランジは、前記ガードを前記組織辺縁の遠位端部に対して定着させるよう構成され、前記側壁は、前記体開口部に沿って前記組織辺縁を周方向に保護し、前記側壁は、前記近位フランジと前記遠位フランジとの間に配置されたネック部分を有し、前記側壁は、前記常態の非変形形態から変形可能であり、解放されると、前記常態の非変形形態に戻るよう付勢されている、ガード。 - 組織の辺縁を画定する体開口部を通る耐切断性経路を提供するガードであって、前記ガードは、
第1の端部と第2の端部との間で長手方向軸線に沿って延びる中央ルーメンを画定する管の形状を備えた側壁を有し、前記側壁は、耐切断性メッシュ材料で作られ、前記耐切断性メッシュ材料は、前記メッシュ材料の管状の第1の層内に隙間を形成する複数の織編フィラメントを有し、前記側壁は、前記ガードの遠位端部のところに折り目を作るよう折り畳まれ、前記側壁の前記第1の端部と前記第2の端部は、前記ガードの近位端部のところで互いに隣接して位置し、前記折り畳まれた側壁は、前記管状の第1のメッシュ材料層と実質的に同軸である管状の第2のメッシュ材料層を形成する、ガード。 - 体開口部に沿って組織辺縁を保護するガードであって、
複数の製織ポリマーフィラメントを備えた耐切断性メッシュ材料の管を有し、前記管は、第1の端部および第2の端部を有するとともに長手方向軸線に沿って中央ルーメンを備え、前記管は、前記第1の端部および前記第2の端部のうちの一方のところに形成された少なくとも1つのフランジを有する常態の非変形形状を備え、前記少なくとも1つのフランジは、次第に増大する直径を定める前記長手方向軸線から周方向外方に延び、前記管は、前記近位端部と前記遠位端部との間に配置されたネック部分を有し、前記ネック部分は、前記少なくとも1つのフランジの前記直径よりも小さな直径を有し、前記少なくとも1つのフランジは、前記フランジが前記常態の非変形形状に対して小さな外側直径を有する縮小形態に遠位側に折り畳めるよう構成されている、ガード。 - 組織の辺縁を保護するために体開口部を通る耐切断性経路を提供するガードであって、前記ガードは、
中央ルーメンを画定する管の形状を備えた側壁を有し、前記中央ルーメンは、近位端部のところの近位開口部と遠位端部のところの遠位開口部との間で長手方向軸線に沿って延び、前記側壁は、隙間を形成する複数の織編フィラメントを有する柔軟性の耐切断性メッシュ材料の少なくとも1つの層で作られ、前記側壁は、前記遠位端部に向かって次第に増大する直径を備えていて、前記側壁中にラッパ形遠位フランジを備えた遠位部分を有し、前記遠位フランジは、前記ガードを前記組織辺縁の遠位端部に対して定着させるよう構成され、前記側壁は、前記体開口部に沿って前記組織辺縁を周方向に保護し、前記側壁は、前記遠位フランジに対して近位側に配置されたネック部分を有し、
前記遠位フランジ周りに周方向に配置されたプルワイヤを有し、前記プルワイヤは、縮小形態に引かれると、前記遠位フランジの外側寸法を減少させ、前記縮小形態にあるとき、前記ガードの挿入および取り出しを容易にするよう構成されている、ガード。 - 組織ガードを製造する方法であって、
隙間を形成する複数の織編フィラメントを有する柔軟性メッシュ材料の管を提供するステップを含み、前記管は、形状が実質的に円筒形であり、近位端部のところの近位開口部と遠位端部のところの遠位開口部との間で長手方向軸線に沿って延びる中央ルーメンを有し、
少なくとも1つの外方にラッパ形状に広がったフランジを有するマンドレルを用意するステップを含み、
前記メッシュ管を前記マンドレルに取り付けて前記マンドレルが前記中央ルーメンの内部に配置され、そして前記管が前記マンドレルを包囲するようにするステップを含み、
前記メッシュ管が前記マンドレルに嵌められている間に前記メッシュ管を加熱するステップを含み、
前記フィラメントを塑性変形させて前記メッシュ管が前記マンドレルから取り外されたときに前記メッシュ管が前記マンドレルの形状に実質的に一致するようにするステップを含み、
前記メッシュ管を前記マンドレルから取り外すステップを含む、方法。 - 前記メッシュ材料は、前記長手方向軸線に対して側方に伸張するよう構成され、前記側壁は、前記常態の非変形形態にあるときの前記ネック部分のところの前記中央ルーメンの前記外側寸法に対して前記ネック部分のところの前記中央ルーメンの前記外側寸法を拡大するよう拡張可能である、請求項1~4のうちいずれか一に記載のガード。
- 前記メッシュ材料は、前記長手方向軸線に沿う前記ガードの軸方向寸法を減少させている間、前記ネック部分が前記ガードの前記外側寸法を長くするよう外側に拡張可能であるようになるよう構成されている、請求項1~4および6のうちいずれか一に記載のガード。
- 前記遠位フランジのところの前記隙間は、前記常態の非変形形態での前記ネック部分のところの前記隙間よりも大きい、請求項1~4、6および7のうちいずれか一に記載のガード。
- 前記メッシュ材料は、前記長手方向軸線に対して側方に伸張して前記側壁が前記常態の非変形形態にあるときの前記ネック部分のところの前記中央ルーメンの前記隙間に対して前記ネック部分のところの前記中央ルーメンの前記隙間を拡大するよう拡張可能であるように構成されている、請求項1~4および請求項6~8のうちいずれか一に記載のガード。
- 前記ガードは、前記遠位フランジが遠位側に撓められて前記遠位端部および前記遠位フランジの前記外側寸法が前記常態の非変形形態に対して減少するよう前記ガードの前記軸方向寸法を長くする変形形態を有する、請求項1~4および請求項6~9のうちいずれか一に記載のガード。
- 前記ガードは、前記遠位端部のところの前記外側寸法が常態の非変形形態における前記遠位端部の前記外側寸法に対して減少した変形形態を有する、請求項1~4および請求項6~10のうちいずれか一に記載のガード。
- 前記遠位フランジは、前記常態の非変形形態にあるときに前記長手方向軸線から周方向外方に延び、前記遠位フランジは、前記遠位フランジが前記体開口部中への挿入を容易にするよう前記常態の非変形形態に対して前記長手方向軸線から周方向外方に延びる程度を減少させるよう遠位側の方向に撓むことができる、請求項1~4および請求項6~11のうちいずれか一に記載のガード。
- 前記ガードの前記遠位端部周りに周方向に隙間を通って製織されたプルワイヤを更に有し、前記プルワイヤは、引かれると、前記遠位端部の前記外側寸法を減少させるよう構成されている、請求項1~4および請求項6~12のうちいずれか一に記載のガード。
- 前記遠位端部のところに周方向に配置されるとともに引かれると、前記遠位フランジを縮小させるよう構成されたプルワイヤを更に有する、請求項1~4および請求項6~13のうちいずれか一に記載のガード。
- 周方向リングまたはビードを更に有し、前記側壁の前記第1の端部と前記第2の端部の両方は、前記リングまたはビード内に配置されている、請求項1~4および請求項6~14のうちいずれか一に記載のガード。
- 前記ガードの前記近位端部のところに形成された近位フランジおよび前記ガードの前記遠位端部のところに形成された遠位フランジを更に有し、前記近位フランジは、前記近位端部に向かって次第に拡径している中央ルーメンによって構成され、前記遠位フランジは、前記遠位端部に向かって次第に拡径している中央ルーメンによって構成されている、請求項1~4および請求項6~15のうちいずれか一に記載のガード。
- 前記側壁は、熱硬化性ポリマーフィラメントで作られている、請求項1~4および請求項6~16のうちいずれか一に記載のガード。
- 前記ガードは、砂時計の形状を有する、請求項1~4および請求項6~17のうちいずれか一に記載のガード。
- 前記ガードは、少なくとも、前記メッシュ材料を側方の方向に伸張させて前記フィラメントを互いに対して動かすとともに前記ガードの前記長手方向寸法を縮小している間に前記隙間を拡張することによって側方に拡張可能である中央ネック部分を有する、請求項1~4および請求項6~18のうちいずれか一に記載のガード。
- 前記ガードは、少なくとも、側方縮小が可能であるよう構成された遠位部分を有する、請求項1~4および請求項6~19のうちいずれか一に記載のガード。
- 前記外側に延びる遠位フランジは、前記ガードの体開口部への挿入および前記体開口部からの前記ガードの取り出しを容易にするよう前記ガードの前記遠位端部の前記外側寸法を減少させるよう遠位側の方向に下方へ折り畳まれるようになっている、請求項1~4および請求項6~20のうちいずれか一に記載のガード。
- 前記側壁は、前記側壁がそれ自体オーバーラップして前記中央ルーメンを周方向に包囲するメッシュ材料の2つの同軸層を形成するよう前記遠位端部のところに折り目を有する、請求項1~4および請求項6~21のうちいずれか一に記載のガード。
- 前記メッシュ材料は、前記長手方向軸線に対して側方に伸張して前記管が前記常態の非変形形状にあるときに前記ネック部分の前記外側寸法に対して前記ネック部分の直径を拡大するよう拡張可能であるように構成されている、請求項1~4および請求項6~22のうちいずれか一に記載のガード。
- 前記プルワイヤが解放されると、前記遠位フランジは、常態の非変形形態に戻るよう付勢されている、請求項1~4および請求項6~23のうちいずれか一に記載のガード。
- マンドレルを用意する前記ステップは、各部分が遠位側の外方にラッパ形状に広がったフランジを有する2つの部分を備えたマンドレルを用意するステップを含む、請求項5記載の方法。
- 前記マンドレルへの前記メッシュ管の取り付け前に二重層メッシュ管を作るよう前記メッシュ管を前記中央ルーメン中に折り畳むステップを更に含む、請求項5または25記載の方法。
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