JP6629956B2 - 弁膜留め具 - Google Patents
弁膜留め具 Download PDFInfo
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- JP6629956B2 JP6629956B2 JP2018503495A JP2018503495A JP6629956B2 JP 6629956 B2 JP6629956 B2 JP 6629956B2 JP 2018503495 A JP2018503495 A JP 2018503495A JP 2018503495 A JP2018503495 A JP 2018503495A JP 6629956 B2 JP6629956 B2 JP 6629956B2
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Description
(2)製造が簡単、成熟:本発明に係る留め具の設計が簡単で、その製造方法は現在常用されている血管ステントとデリバリーシステムに類似するため、製造が相対的に簡単、成熟している。
(3)手術の操作難易度が低い:本発明の一実施形態は、心尖部ルートを経て完成し、前胸部から左心室に入って弁膜箇所まで直接に到達し、手術の入口部から弁膜までの距離が非常に近く、シースのアクセスルートが真っ直ぐで短く、デリバリーシステムの湾曲を調整する必要がないため、調整や制御しやすく、手術操作も比較的容易である。
(4)確実な効果:外科のエッジトゥエッジ縫合技術の僧帽弁逆流に対する治療作用は、明確に実証されている。本発明に係る弁膜留め具は、現在の外科手術のエッジトゥエッジ縫合技術原理に基づいて設計され、留め具が植え込まれた後、最終的に僧帽弁の両弁尖を止め、外科のエッジトゥエッジ縫合手術と同様の効果を奏する。
2)デリバリーシースを左心室に挿入した後、僧帽弁の弁口を横断して左心房に到達し、デリバリーシースを引き戻して第1保持部材をデリバリーシースから離脱させると共に左心房内で開かせ;
3)引き続きデリバリーシースを左心室まで引き戻し、第2保持部材をデリバリーシースから離脱させると共に左心室内で開かせ;
4)第2保持部材を上へ押し上げて、僧帽弁の弁尖を左心房に向かって押すと共に動きを減らさせ、第1保持部材を下へ引っ張り、差込片がロックリングのアイ部を通過した後、2組の保持アームが堅牢に閉じて保持具を形成させ、2組の保持具が2個の僧帽弁の弁尖を挟持し;
5)デリバリーシースを上へ押し上げて2組の保持具の一部をデリバリーシースに収め、デリバリーチューブの回転によって拘束環を回転し、2組の保持具を拘束環内に収納して軸心線へ引き寄せ;
6)デリバリーシースを引き戻し、デリバリーバーを締め出し、拘束環とデリバリーチューブを分離させ、最終的に留め具を解放して手術を完了し、留め具が体内に留置し、僧帽弁の弁尖を保持する。
Claims (12)
- 弁膜留め具であって第1保持部材と第2保持部材と連結部材とを含み;前記第1保持部材は、少なくとも2個の第1保持アームを含み、前記第2保持部材が前記第1保持アームと対応する第2保持アームを含み、各前記第1保持アームが対応する前記第2保持アームと組み立てることで1組の保持具となり、両者は互いに近付けると共に圧縮して生じた相互作用力を通じてその中の物体を挟持し;前記連結部材は、前記第1保持部材と前記第2保持部材を連結するために用いられ;前記連結部材は、互いにマッチするロック棒とロックリングとを含み;前記第1保持部材と前記第2保持部材が各々前記ロック棒又は前記ロックリングと連結し、前記ロック棒が前記ロックリングのアイ部内に挿入されることで前記第1保持部材と前記第2保持部材との連結を実現し、かつ前記ロック棒と前記ロックリングの間にロック部材を更に設け;拘束環を更に含み、前記拘束環が前記ロックリングの外周に締め込まれることを特徴とする弁膜留め具。
- 前記第1保持アームは、前記留め具の前方に向けて傾斜し、前記第2保持アームも前記留め具の前方に向かって傾斜しているが、その傾斜角は前記第1保持アームの傾斜角より大きく;前記弁膜留め具は、体内にデリバリーされるものであり、前記留め具の前方とは、デリバリー軸に沿って操作者から離れた方向であり、前記第1保持アームの傾斜角は、前記第1保持アームと、前記連結部材の軸方向と直交する方向との間の夾角を意味し、前記第2保持アームの傾斜角は、前記第2保持アームと、前記連結部材の軸方向と直交する方向との間の夾角を意味し、前記第1保持アームと前記第2保持アームが互いに近付くとき、前記第1保持アームと前記第2保持アームが接するまで、それぞれの前記傾斜角が維持されることを特徴とする請求項1に記載の弁膜留め具。
- 前記第1保持アームの傾斜角は、20〜30度、前記第2保持アームの傾斜角が25〜35度であることを特徴とする請求項2に記載の弁膜留め具。
- 前記第1保持アームと前記第2保持アームの対向面に若干の突起を有することを特徴とする請求項1に記載の弁膜留め具。
- 前記第1保持アームの数量は、2個或いは3個であることを特徴とする請求項1に記載の弁膜留め具。
- 前記ロック棒は、角柱形であり、前記ロックリングのアイ部が対応する角柱形孔であることを特徴とする請求項1〜5のいずれか1項に記載の弁膜留め具。
- 前記ロック部材は、前記ロック棒上に設けられ、弾性差込片とすることを特徴とする請求項1〜6のいずれか1項に記載の弁膜留め具。
- 前記拘束環の内表面にメスネジが設けられ、前記ロックリング外表面にオスネジが設けられ、両者が互いにマッチすることを特徴とする請求項1〜7のいずれか1項に記載の弁膜留め具。
- 請求項1〜8のいずれか1項に記載の弁膜留め具をデリバリーするためのデリバリー装置であって、デリバリーバーとデリバリーチューブとデリバリーシースとを含み;前記デリバリーバーは、前記ロック棒と互いに連結し、前記ロック棒と連結する第1保持部材或いは第2保持部材をデリバリーするために用いられ;前記デリバリーチューブは、前記ロックリングと互いに連結し、前記ロックリングと連結する第2保持部材或いは第1保持部材をデリバリーするために用いられ;前記デリバリーシースは、前記弁膜留め具を被覆し、同時にデリバリー軌道を提供するために用いられることを特徴とするデリバリー装置。
- 請求項1〜8のいずれか1項に記載の弁膜留め具をデリバリーするためのデリバリー装置であって、デリバリーバーと、デリバリーチューブとデリバリーシースとを含み;前記デリバリーバーは、前記ロック棒と互いに連結し、前記ロック棒と連結する第1保持部材或いは第2保持部材をデリバリーするために用いられ;前記デリバリーチューブは、前記拘束環と互いに連結し、前記ロックリングと連結する第2保持部材或いは第1保持部材をデリバリーするために用いられ、前記デリバリーチューブ先端に拘束環連結部材を設けており、前記拘束環を取り外し可能に前記デリバリーチューブと接続させることができ;前記デリバリーシースは、前記弁膜留め具を被覆し、同時にデリバリー軌道を提供するために用いられることを特徴とするデリバリー装置。
- 弁膜留め具システムであって、弁膜留め具とデリバリー装置とを含み;前記弁膜留め具は、第1保持部材と第2保持部材と連結部材とを含み;前記第1保持部材は、少なくとも2個の第1保持アームを含み、前記第2保持部材が前記第1保持アームと対応する第2保持アームとを含み、各前記第1保持アームが対応する前記第2保持アームと組み立てることで1組の保持具となり、両者は互いに近付けると共に圧縮して生じた相互作用力を通じてその中の物体を挟持し;前記連結部材は、前記第1保持部材と前記第2保持部材を連結するために用いられ;前記連結部材は、互いにマッチするロック棒とロックリングとを含み;前記第1保持部材と前記第2保持部材が各々前記ロック棒又は前記ロックリングと連結し、前記ロック棒が前記ロックリングのアイ部内に挿入されることで前記第1保持部材と前記第2保持部材との連結を実現し、かつ前記ロック棒と前記ロックリングの間にロック部材を更に設け;拘束環を更に含み、前記拘束環が前記ロックリングの外周に締め込まれ;前記デリバリー装置は、デリバリーバーとデリバリーチューブとデリバリーシースとを含み;前記デリバリーバーは、前記ロック棒と互いに連結し、前記ロック棒と連結する第1保持部材或いは第2保持部材をデリバリーするために用いられ;前記デリバリーチューブは、前記ロックリングと互いに連結し、前記ロックリングと連結する第2保持部材或いは第1保持部材をデリバリーするために用いられ;前記デリバリーシースは、前記弁膜留め具を被覆し、同時にデリバリー軌道を提供するために用いられることを特徴とする弁膜留め具システム。
- 請求項10に記載のデリバリー装置であって、前記第1保持アーム及び前記第2保持アームは、いずれも完全に半径方向に収縮する第1形態、完全に半径方向に拡張する第2形態及び半収縮半拡張の第3形態を有し、前記第1形態は前記留め具がデリバリー装置でデリバリーされる時の形態で、前記第2形態は前記留め具がデリバリー装置内から解放された後の形態で、前記第3形態は前記留め具が弁膜組織を挟持した後のワーキング形態であり、前記第3形態は、前記ロックリングが前記拘束環に締め込んだ後、前記保持具を前記拘束環内に収納して軸心線へ引き寄せた形態であることを特徴とするデリバリー装置。
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CN106175986B (zh) * | 2016-07-26 | 2017-12-01 | 复旦大学附属中山医院 | 一种瓣膜夹合器 |
US10398553B2 (en) * | 2016-11-11 | 2019-09-03 | Evalve, Inc. | Opposing disk device for grasping cardiac valve tissue |
US10130475B1 (en) * | 2018-01-09 | 2018-11-20 | Edwards Lifesciences Corporation | Native valve repair devices and procedures |
US10231837B1 (en) * | 2018-01-09 | 2019-03-19 | Edwards Lifesciences Corporation | Native valve repair devices and procedures |
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2016
- 2016-07-26 CN CN201610594219.8A patent/CN106175986B/zh active Active
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2017
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- 2017-02-15 US US15/736,298 patent/US10603168B2/en active Active
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EP3323353B1 (en) | 2021-06-23 |
JP2018525080A (ja) | 2018-09-06 |
EP3323353A4 (en) | 2019-11-20 |
ES2890849T3 (es) | 2022-01-24 |
CN106175986B (zh) | 2017-12-01 |
CN106175986A (zh) | 2016-12-07 |
WO2018018873A1 (zh) | 2018-02-01 |
EP3323353A1 (en) | 2018-05-23 |
US10603168B2 (en) | 2020-03-31 |
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