JP2021518775A - 心臓弁ドッキングデバイスおよびシステム - Google Patents
心臓弁ドッキングデバイスおよびシステム Download PDFInfo
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Abstract
Description
本出願は、2018年2月22日に出願された米国特許出願第15/902956号の優先権を主張し、米国特許出願第15/902956号は、2017年8月21日に出願された米国特許出願第15/682287号の一部継続出願であり、米国特許出願第15/682287号は、2016年9月16日に出願された米国仮特許出願第62/395940号および2016年8月26日に出願された米国仮特許出願第62/380117号の利益を主張する。これらの出願は、参照によりその全体が本明細書に組み込まれている。
10、110、1110 中央領域
20、120、1120 下部領域
21 遠位先端
21 遠位または誘導先端
30、130、1130 上部領域
31 近位先端
32 長径
33 短径
40 人工弁
41 拡張可能なフレーム構造
42 弁尖
50 僧帽弁
52 左心房
54 左心室
56 大動脈弁
58 大動脈
62 腱索
64 交連部
66 前尖
68 後尖
140、1140 伸張領域
150 穴
210 レーザーカットチューブ
211、216、217、218 切り込み
212 リンク
213、218 歯
214、618 溝
215 端部領域
217 開口部
219 ロッキングワイヤ
219 張力ワイヤ
222 遠位端
310、510 メインコイル
320 アンカー
410、610、710、810、910 コイル/コア
420 被膜
520 摩擦要素
530 高摩擦被膜
622 突起
712 先端
714 通し穴
716、918 自由端
718 反対側の端部
720 固着穴
812 ボール状先端
814 隙間
912 スリット穴
914、916 側部
915a、915b 近位突起
919a、919b 近位凹状溝
920 カバー層
930 縫合糸
940 プルワイヤ
941 縫合糸
950 溝
1000 ガイドシース、イントロデューサ
1010 デリバリーカテーテル
1160 ワイヤコア
1162 穴
1163 縫合糸
1164 固定穴
1165 プッシャーチューブ
1170 カバー層、低摩擦層
1180 高摩擦層、編み層
1182、1184 マーカーバンド
1200 球形近位先端/端部
1202 球形部
1204 遷移部
1206 ネック部
1210 中央通路
1212 側部通路
1220 チャネル、環状くぼみ
1230 ボア
1232 ボアベース
1240 アイレット
1300 ループ状近位先端
1302 平坦な縦表面
1304 遠位端
1306 接続点
1310 内側ループ表面
1312 外側ループ表面
1340 ボア
1800 左心房
1810 僧帽弁
1830 大動脈壁
1840 大動脈
2700 端部
A1P1、A3P3 交連
Claims (48)
- 自然弁の所にドッキングデバイスを移植するためのシステムであって、
デリバリーカテーテルと、
端部を有する細長いコイル状ドッキングデバイスと、
中央ルーメンを有するプッシャーデバイスであって、前記デリバリーカテーテル内に配設されたプッシャーデバイスと、
前記デリバリーカテーテルの前記中央ルーメンを通して延び、前記コイル状ドッキングデバイスの前記端部に結合された回収線と、
を備え、
前記システムは、前記回収線を引くと、前記プッシャーデバイスに対して前記コイル状アンカーの前記端部が引かれるように構成され、
前記端部および前記回収線は、前記引くことによる張力が、前記コイル状ドッキングデバイスの前記端部の中心軸に実質的に整合されるように偏らされるように構成され結合されるシステム。 - 前記端部は、前記回収線の少なくとも長さ方向部分を前記中心軸に沿って整合するように構成される、請求項1に記載のシステム。
- 前記回収線は、前記ドッキングデバイスの前記端部の先端の所における中央通路を通って延び、前記中央通路は前記中心軸に整合される、請求項1に記載のシステム。
- 前記ドッキングデバイスは、球形先端をさらに備える、請求項1に記載のシステム。
- 前記球形先端は、前記コイル状ドッキングデバイスの前記端部の中心軸に整合された通路を通して前記回収線を受ける、請求項4に記載のシステム。
- 前記球形近位先端は、前記球形近位先端の遷移部に環状溝を備える、請求項5に記載のシステム。
- 前記プッシャーデバイスの遠位端は、前記コイル状アンカーの前記端部の所で球形表面に係合するように構成される、請求項1に記載のシステム。
- 前記ドッキングデバイスの前記端部は、ループを含む先端を備え、前記回収線は前記ループに接続される、請求項1に記載のシステム。
- 前記ドッキングデバイスの前記端部は、溝を含む先端を備え、回収縫合糸は、前記溝内の前記端部に結合される、請求項1に記載のシステム。
- 前記コイル状ドッキングデバイスは、
第1の厚さを有し、中央巻き直径を画定する少なくとも1つの中央巻きと、
前記少なくとも1つの中央巻きの近位端から延びる長さを有する伸張部であって、前記第1の厚さよりも小さい第2の厚さを有する伸張部と、
前記伸張部の近位端から延びる近位巻きであって、前記第2の厚さよりも大きい第3の厚さを有する近位巻きと、
を備える、請求項1から9のいずれか一項に記載のシステム。 - 前記コイル状ドッキングデバイスは、前記端部に対して前記コイル状ドッキングデバイスの反対側の端部上に遠位巻きを備え、前記遠位巻きは、前記第1の厚さを有し、前記中央巻き直径よりも大きい直径を画定する、請求項10に記載のシステム。
- 前記コイル状ドッキングデバイスの前記端部は、前記近位巻きの近位端の所に位置する、請求項10に記載のシステム。
- 前記コイル状ドッキングデバイスは、自然弁の所に移植されるように構成され、前記コイル状ドッキングデバイスの少なくとも一部が、心臓の心腔内および前記自然弁の弁尖の周りに配置される、請求項10に記載のシステム。
- 前記コイル状ドッキングデバイスは、自然僧帽弁の所に移植されるように構成され、前記コイル状ドッキングデバイスの少なくとも一部が、左心室内および前記自然僧帽弁の僧帽弁尖の周りに配置される、請求項13に記載のシステム。
- 前記コイル状ドッキングデバイスは、自然三尖弁の所に移植されるように構成され、前記コイル状ドッキングデバイスの少なくとも一部が、左心室内および前記自然三尖弁の三尖弁尖の周りに配置される、請求項13に記載のシステム。
- 生体適合材料を備えるカバー層をさらに備え、前記カバー層は、前記コイル状アンカーの少なくとも一部を囲む、請求項1から15のいずれか一項に記載のシステム。
- 前記カバー層は低摩擦カバー層であり、
前記低摩擦カバー層は、遠位端と近位端とを有し、前記コイル状ドッキングデバイスを囲み、前記コイル状ドッキングデバイスの長さに沿って、前記コイル状ドッキングデバイスの遠位先端を越え、前記コイル状ドッキングデバイスの近位先端を越えて延び、
前記低摩擦カバー層は、その遠位端の所の丸い先端まで先細りする、請求項16に記載のシステム。 - 前記カバー層の少なくとも一部を囲みかつ前記少なくとも一部に沿って延びる第2のカバー層を備える摩擦強化要素をさらに備え、前記第2のカバー層は、摩擦係数が少なくとも1である、請求項16に記載のシステム。
- 前記第2のカバー層は編み材料である、請求項18に記載のシステム。
- 前記コイル状ドッキングデバイスは、
中央巻き直径を画定する少なくとも1つの中央巻きと、
前記中央巻き直径よりも大きい直径を画定する、前記少なくとも1つの中央巻きから延びる下部巻きと、
前記少なくとも1つの中央巻きに接続された上部巻きであって、第1の軸に沿った第1の直径と第2の軸に沿った第2の直径とを有するように形作られた上部巻きとを備え、
前記第1の軸直径は、前記中央巻き直径よりも大きく、前記第2の軸直径は、前記中央巻き直径よりも大きく、前記下部巻き直径よりも小さい、請求項1から19のいずれか一項に記載のシステム。 - 前記コイル状ドッキングデバイスは、
近位端と遠位端とを有する中空チューブと、
前記中空チューブの各部を貫通する複数の切り込みと、
長さと、近位端と、遠位端とを有するワイヤと、
を備え、
前記ワイヤの前記遠位端は、前記中空チューブの遠位端に固定され、前記ワイヤの前記近位端は、前記中空チューブの近位端に固定され、
前記ワイヤの前記長さは、前記中空チューブを通って延び、前記中空チューブに半径方向内側への張力を加える、請求項1から20のいずれか一項に記載のシステム。 - 前記切り込みは、前記中空チューブに歯および溝を形成する縦方向切り込みと横方向切り込みの両方を組み込んだパターンおよび形状を有する、請求項21に記載のシステム。
- 前記コイル状ドッキングデバイスは、コアを含み、前記コアの遠位端は、矩形断面と遠位巻リング状先端とを有する、請求項1から22のいずれか一項に記載のシステム。
- 前記コイル状ドッキングデバイスは、コアを含み、前記コアの少なくとも1つの端部はボール状先端を有する、請求項1から22のいずれか一項に記載のシステム。
- 心臓の自然弁の所に人工弁をドッキングするためのドッキングデバイスであって、
中心軸を含む端部を有するコイル状ドッキングデバイスを備え、
前記ドッキングデバイスの前記端部は、前記端部に接続された回収縫合糸が偏らされて、張力によって前記回収縫合糸に加えられる力の線が前記中心軸に整合されるように構成されるドッキングデバイス。 - 前記端部は、前記回収縫合糸の少なくとも長さ方向部分を前記中心軸に沿って整合するように構成される、請求項25に記載のデバイス。
- 前記回収縫合糸は、前記ドッキングデバイスの前記端部の先端の所における中央通路を通って延び、前記中央通路は前記中心軸に整合される、請求項25に記載のデバイス。
- 前記コイル状ドッキングデバイスは、前記回収縫合糸を受ける球形先端を前記近位端部上にさらに備える、請求項25に記載のデバイス。
- 前記球形先端は、前記球形先端の遷移部に環状溝を備える、請求項28に記載のデバイス。
- 前記ドッキングデバイスの前記端部は、溝を含む先端を備え、前記回収縫合糸は、前記回収縫合糸の一部が前記溝に結び付けられた前記端部に結合される、請求項25に記載のデバイス。
- 前記コイル状ドッキングデバイスは、
第1の厚さを有し、中央巻き直径を画定する少なくとも1つの中央巻きと、
前記少なくとも1つの中央巻きの上端部から延びる長さを有する伸張部であって、前記第1の厚さよりも小さい第2の厚さを有する伸張部と、
前記遷移部の上端部から延びる上部巻きであって、前記第2の厚さよりも大きい第3の厚さを有する上部巻きと、
を備える、請求項25から30のいずれか一項に記載のデバイス。 - 前記コイル状ドッキングデバイスは、前記端部に対して前記コイル状ドッキングデバイスの反対側の端部上に遠位巻きを備え、前記遠位巻きは、前記第1の厚さを有し、前記中央巻き直径よりも大きい直径を画定する、請求項31に記載のデバイス。
- 前記コイル状ドッキングデバイスは、自然弁の所に移植されるように構成され、前記コイル状ドッキングデバイスの少なくとも一部が、心臓の心腔内および前記自然弁の弁尖の周りに配置される、請求項31に記載のデバイス。
- 前記コイル状ドッキングデバイスは、自然僧帽弁の所に移植されるように構成され、前記コイル状ドッキングデバイスの少なくとも一部が、左心室内および前記自然僧帽弁の僧帽弁尖の周りに配置される、請求項33に記載のデバイス。
- 前記コイル状ドッキングデバイスは、自然三尖弁の所に移植されるように構成され、前記コイル状ドッキングデバイスの少なくとも一部が、左心室内および前記自然三尖弁の三尖弁尖の周りに配置される、請求項33に記載のデバイス。
- 生体適合材料を備えるカバー層をさらに備え、前記カバー層は、前記コイル状アンカーの少なくとも一部を囲む、請求項25から35のいずれか一項に記載のデバイス。
- 前記カバー層は低摩擦カバー層であり、
前記低摩擦カバー層は、遠位端と近位端とを有し、前記コイル状ドッキングデバイスを囲み、前記コイル状ドッキングデバイスの長さに沿って、前記コイル状ドッキングデバイスの遠位先端を越え、前記コイル状ドッキングデバイスの近位先端を越えて延び、
前記低摩擦カバー層は、その遠位端の所の丸い先端まで先細りする、請求項36に記載のデバイス。 - 前記カバー層の少なくとも一部を囲みかつ前記少なくとも一部に沿って延びる第2のカバー層を備える摩擦強化要素をさらに備え、前記第2のカバー層は、摩擦係数が少なくとも1である、請求項36に記載のデバイス。
- 前記第2のカバー層は編み材料である、請求項38に記載のデバイス。
- 前記コイル状ドッキングデバイスは、
中央巻き直径を画定する少なくとも1つの中央巻きと、
前記中央巻き直径よりも大きい直径を画定する、前記少なくとも1つの中央巻きから延びる下部巻きと、
前記少なくとも1つの中央巻きに接続された上部巻きであって、第1の軸に沿った第1の直径と第2の軸に沿った第2の直径とを有するように形作られた上部巻きと、
を備え、
前記第1の軸直径は、前記中央巻き直径よりも大きく、前記第2の軸直径は、前記中央巻き直径よりも大きく、前記下部巻き直径よりも小さい、請求項25から39のいずれか一項に記載のデバイス。 - 前記コイル状ドッキングデバイスは、
近位端と遠位端とを有する中空チューブと、
前記中空チューブの各部を貫通する複数の切り込みと、
長さと、近位端と、遠位端とを有するワイヤと、
を備え、
前記ワイヤの前記遠位端は、前記中空チューブの遠位端に固定され、前記ワイヤの前記近位端は、前記中空チューブの近位端に固定され、
前記ワイヤの前記長さは、前記中空チューブを通って延び、前記中空チューブに半径方向内側への張力を加える、請求項25から40のいずれか一項に記載のデバイス。 - 前記切り込みは、前記中空チューブに歯および溝を形成する縦方向切り込みと横方向切り込みの両方を組み込んだパターンおよび形状を有する、請求項41に記載のデバイス。
- 前記コイル状ドッキングデバイスは、コアを含み、前記コアの遠位端は、矩形断面と遠位巻リング状先端とを有する、請求項25から42のいずれか一項に記載のデバイス。
- 前記コイル状ドッキングデバイスは、コアを含み、前記コアの少なくとも1つの端部はボール状先端を有する、請求項25から42のいずれか一項に記載のデバイス。
- 心臓内からコイル状ドッキングデバイスを回収する方法であって、
回収線を引いてプッシャーデバイスに対してコイル状ドッキングデバイスの端部を引くステップであって、前記コイル状ドッキングデバイスの前記端部は、前記回収線を偏らせて、前記引くステップによって加えられる張力を前記コイル状ドッキングデバイスの前記端部の中心軸に整合するように構成される、ステップと、
プッシャーデバイスおよび前記コイル状ドッキングデバイスの前記端部をデリバリーカテーテルに引き込むステップと、
を含む方法。 - 前記プッシャーデバイスは、前記コイル状ドッキングデバイスの球形端部に当接する、請求項45に記載の方法。
- 前記端部は、前記回収線の少なくとも一部を前記中心軸に沿って整合する、請求項45に記載の方法。
- 前記回収線は、前記ドッキングデバイスの前記端部の先端における中央通路を通って延び、前記中央通路は前記中心軸に整合される、請求項45に記載の方法。
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