JP4921173B2 - 止血クリップ展開装置および止血クリップ・アセンブリ - Google Patents
止血クリップ展開装置および止血クリップ・アセンブリ Download PDFInfo
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Description
創傷部の縁を互いにクランプすることによって内部出血を止める止血クリップを展開するために、止血クリッピング器具を内視鏡を通して挿入してきた。遠位端に取り付けられているクリップを備えたそのようなクリッピング器具は、出血位置へと内視鏡を通して挿入することができる。次いでクリップを出血部位上の位置にくるよう遠隔的に操作し、創傷部上でクランプし、器具から取り外す。
れる従来のコイルとすることができ、例えば単一巻回されたワイヤを含むことができる。巻回されたワイヤは円形、正方形、または矩形の交差部を含むことができ、例えばステンレス鋼などの生体適合性材料から作ることができる。既知の製造方法に従って、シャフト部104上に追加の保護的および低摩擦性外層を含むこともできる。
シース150は、例えばTeflon(商標)、HDPE、ポリプロピレンなどの低摩擦ポリマー、または同様の材料から形成することができる。
64はスナップ式に非伸展位置に戻り、それらの間の定位置にシャフト部104を保持する。シース止め156をシャフト部104から引き離すことによってシャフト部104を取り外す。ブロック部174、176の形状によって、シャフト部104の取り外しには、中に挿入するときよりも大きな力を加える必要がある。フィンガー162、164の過度の伸展によって引き起こされることのある、デバイスへの損傷を防ぐために、シャフト部104が把持部161の方へ動くことを制限するように、止め具180をシース止め156に設けることもできる。シース止め156は、ポリマーなどの弾性材料から形成することができ、射出成形によって製造することができる。
リップ・アーム208がカプセル200内部で近位側に動くと、クリップ止めショルダー(CSS)222がカプセル200の遠位部、例えば折り曲げタブ220に接触する。CSS222とカプセル200のこの相互作用によって、使用者は、摺動スプール110の動きへの抵抗が増加する形で第1の触覚フィードバックを得ることができる。このフィードバックは、操作者に、ハンドル制御をさらに動かすことによって止血クリップ90がクリップ・アセンブリ106から展開されるという明白な指示を与える。次いで操作者は、クリップ90の現在の位置が許容可能かどうかを判断することができる。位置が許容可能であれば、操作者は、ヨーク204を張力部材206から分離するように近位側の圧力を増加させながら、摺動スプール110を動かし続けることによってクリップ90を完全に展開することができる。そうでない場合、操作者は摺動スプール110を遠位側に動かしてクリップ・アーム208を再び開くことができ、それをカプセル200から外へ延ばし、クリップ90を配置し直し、上述のステップを繰り返してクリップ90をより適切な位置で閉じることができる。
細が図18、19および20に示されている。
る状態を示す。上述の実施形態によれば、この第2の使用者フィードバックは、制御ワイヤ118を、所定の張力が加えられると端部球140から分離するように設計することによって得られる。言い換えると、制御ワイヤ118の球140は、あらかじめ設定された張力が加えられると降伏し制御ワイヤ118の本体から分離するように、機械的にプログラムされている。より小径の部分142のサイズは、プログラムされた降伏張力に達したときに使用者が摺動スプール110を近位側に動かし続けると、球140が先細部分144から脱着され、操作者に大きな触覚フィードバックを与えるように、選択することができる。
径部分300を含む。半径部分300の半径はカプセル200の内径にほぼ一致し、カプセル200の内面を擦傷しないように滑らかな断面を有する。半径部分300とばね部404の間に与圧角度αが画成されている。与圧角度αは、2つの向かい合うクリップ・アーム208の間で、閉じているときそれらの遠位端に存在する干渉(与圧)の大きさを決定する。与圧角度αが大きいほど、クリップ・アーム208によってかかる係合力は大きくなる。しかし、この条件はまた、止血クリップ90が閉じているときに最大のシステム摩擦を生じる。クリップ・アーム208はまた、各遠位端に配設された噛合歯408も含む。例示的な実施形態では、アームが交換可能でありそれらと向き合うセットに滑らかに噛合するように、歯408は同一になっている。歯408は、約90度から135度の間であるノーズ角度βで配設されているが、他の適用例では上述の範囲よりも大きくまたは小さくすることもできる。
るために使用することのできる制御ワイヤ810の別の遠位端も組み込んでいる。
た後、クリップ802を完全に解除するよう制御ワイヤ球902を制御ワイヤ810の近位部から分離するように、制御ワイヤ810をさらに近位側に引き寄せることができる。
料を必要とするので、張力部材206をヨーク204から解除するために選択される機構のタイプによって、使用する材料のタイプを決定することができる。
御ワイヤの本体に脱着可能に連結された球を含み、球は、制御ワイヤの本体から分離するとき第2の使用者フィードバックをもたらす。
Claims (31)
- ハンドル・アセンブリと、
同ハンドル・アセンブリの遠位部に連結されたシャフトと、
該シャフトの遠位部に解除可能に連結されたクリップ・アセンブリと、同クリップ・アセンブリは、2つのクリップ・アームと、同クリップ・アームと協働して該クリップ・アセンブリの決定形状を示す第1の使用者フィードバックをもたらすカプセルとを有することと、
球コネクタを含み、該シャフトに連結された該クリップ・アセンブリを維持するように、該ハンドル・アセンブリから延び、該球コネクタによって該クリップ・アセンブリに連結された制御ワイヤとからなり、該球コネクタは、該クリップ・アセンブリから分離可能であり、該クリップ・アセンブリの該シャフトからの分離を示す第2の使用者フィードバックをもたらす止血クリップの展開のための装置。 - 前記シャフトおよび前記クリップ・アセンブリを覆う第1の位置と前記クリップ・アセンブリを露出する第2の位置の間で可動であるオーバーシースをさらに含む請求項1に記載の装置。
- 前記オーバーシースが前記第2の位置へ動かないように、前記シャフト上で係合可能なオーバーシース止めをさらに含む請求項2に記載の装置。
- 前記制御ワイヤが近位側に動く間に前記第1の使用者フィードバックをもたらすように、前記クリップ・アームが前記カプセルの遠位端に係合する止めショルダーをさらに含む請求項1に記載の装置。
- 前記決定形状が、前記制御ワイヤがそれを越えてさらに近位側に動くと前記制御ワイヤを反対に動かすことによって前記クリップ・アームが開位置に戻ることが不可能になる、前記制御ワイヤの位置である請求項1に記載の装置。
- 前記カプセルが、
前記球コネクタを受ける球空洞部を含み、前記カプセル内部で摺動可能なヨークと、
該ヨークに解除可能に連結され、前記クリップ・アームに連結され、前記クリップ・アームを開形状に向かって付勢する張力部材とをさらに含み、第1の使用者フィードバックが得られる位置を越えて近位側に制御ワイヤが移動されると、該張力部材が該ヨークから解除する請求項1に記載の装置。 - 前記張力部材および前記ヨークが、雄型C字形断面部材および雌型C字形断面部材によって、互いに解除可能に連結されている請求項6に記載の装置。
- 前記ヨークと前記張力部材の分離が、前記雄型C字形断面部材の破断および変形の一方によって起こる請求項7に記載の装置。
- 前記ヨークと前記張力部材との分離が、前記制御ワイヤの張力が少なくとも所定の分離張力であるときに起こる請求項8に記載の装置。
- 前記分離張力が少なくとも17.7929ニュートン(4ポンド重)である請求項9に記載の装置。
- 前記分離張力が53.3786ニュートン(12ポンド重)未満である請求項9に記載の装置。
- 前記ヨークと前記張力部材との分離が、張力部材とクリップ・アームとをカプセル内で基端側に摺動させることにより、前記クリップ・アームを閉形状にロックする請求項6に記載の装置。
- 前記ヨークと前記張力部材との分離により、ヨークが近位側に動かされ該カプセルが該シャフトのブシュから解除される請求項6に記載の装置。
- 前記ヨークを前記張力部材から分離する前に、前記制御ワイヤを遠位側に動かすことによって、前記クリップ・アームを開形状にすべく前記カプセルから外へ遠位側に摺動させる請求項6に記載の装置。
- 前記第1のフィードバックが触覚および聴覚フィードバックの一方を含む請求項1に記載の装置。
- 前記制御ワイヤが、前記球コネクタに隣接する、より小径の部分をさらに含み、前記制御ワイヤの張力が所定の降伏張力に至ると、該より小径の部分が降伏する請求項1に記載の装置。
- 前記降伏張力が請求項9に記載の分離張力より大きい請求項16に記載の装置。
- 前記降伏張力が、44.4822ニュートン(10ポンド重)と約88.9644ニュートン(20ポンド重)の間である請求項16に記載の装置。
- カプセルと、
クリップを該カプセル内へと近位側に引き寄せるとクリップのアームが閉位置へと互いに引き寄せられ、クリップを該カプセル内部で所定の位置へと引き寄せると少なくとも1つのアームの当接面が該カプセルの対応する表面に接触し、クリップが閉じたことを示す第1の使用者フィードバックがもたらされるように、該カプセル内部に摺動可能に設置されたクリップと、
クリップ・アームに連結され、該クリップ・アームを開形状、組織を受ける形状に向かって付勢する張力部材と、
該カプセル内部で摺動可能に受けられ、該張力部材に解除可能に連結され、デリバリー・デバイスに連結されたクリップ・アセンブリを維持するようにデリバリー・デバイスの制御要素の球コネクタを受ける球空洞部を含むヨークとからなり、該制御要素が該ヨークを該デリバリー・デバイスから切り離し、第2の使用者フィードバックをもたらすように脆弱であり、該ヨークを該張力部材から解除することによって第3の使用者フィードバックをもたらす、デリバリー・デバイスに設置するための止血クリップ・アセンブリ。 - 前記カプセルが、前記当接面が前記カプセルの対応する表面に接触するとき、前記ヨークの近位端が前記カプセルの近位端から延び、前記カプセルを前記デリバリー・デバイスの遠位端と位置合わせするようなサイズである請求項19に記載のクリップ・アセンブリ。
- 前記第1の使用者フィードバックが、前記制御要素がそれを越えてさらに近位側に動くと前記制御要素を反対に動かすことによって前記クリップ・アームが開形状に戻ることが不可能になる位置を示す請求項19に記載のクリップ・アセンブリ。
- 前記張力部材および前記ヨークの第1の一方が雄型C字形断面部材を含み、前記張力部材および前記ヨークの他方が該雄型C字形断面部材を解除可能に受ける雌型C字形断面部材を含む請求項19に記載のクリップ・アセンブリ。
- 前記ヨークの前記張力部材からの分離が、前記雄型C字形断面部材の破断および変形の一方によって起こる請求項22に記載のクリップ・アセンブリ。
- 前記ヨークおよび前記張力部材が、少なくとも所定の分離張力の張力がかかるときにのみ分離する請求項23に記載のクリップ・アセンブリ。
- 前記分離張力が少なくとも17.7929ニュートン(4ポンド重)である請求項24に記載のクリップ・アセンブリ。
- 前記分離張力が53.3786ニュートン(12ポンド重)未満である請求項24に記載のクリップ・アセンブリ。
- 前記ヨークの前記張力部材からの分離が、前記クリップ・アームを閉形状にロックする請求項19に記載のクリップ・アセンブリ。
- 前記ヨークの前記張力部材からの分離によって、前記カプセルを前記制御要素から解除するように、前記ヨークがさらに近位側に動くことが可能である請求項19に記載のクリップ・アセンブリ。
- 前記ヨークを前記張力部材から分離する前に、前記制御要素を遠位側に動かすことが、前記クリップ・アームを前記カプセルから外へ遠位側に開形状へと摺動する請求項19に記載のクリップ・アセンブリ。
- 前記第1のフィードバックが触覚および聴覚フィードバックの一方を含む請求項19に記載のクリップ・アセンブリ。
- 前記カプセルがその近位端に隣接して形成される複数のタブ受け開口を含み、該タブ受け開口が前記カプセルの軸に対する角度に向けられている請求項19に記載のクリップ・アセンブリ。
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PCT/US2004/032444 WO2005032381A2 (en) | 2003-09-30 | 2004-09-30 | Through the scope tension member release clip |
US10/955,624 | 2004-09-30 |
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EP3878381A3 (en) | 2021-11-10 |
CA2539979A1 (en) | 2005-04-14 |
US20050080440A1 (en) | 2005-04-14 |
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US8974371B2 (en) | 2015-03-10 |
US7452327B2 (en) | 2008-11-18 |
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EP3443915B2 (en) | 2024-01-31 |
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