JP4328209B2 - 心耳血液ろ過システム - Google Patents
心耳血液ろ過システム Download PDFInfo
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Description
本発明は、心耳とその関連心房との間の心臓血流のろ過に関する。血液ろ過は、心耳内に形成され得る血栓が身体血流循環系へ分散することを防ぐ。特に、本発明は植込みろ過装置およびそのような装置を心臓内に経皮送達し、植え込むための器具に関する。
本発明は、心耳と関連心房との間の血流をろ過するため、フィルタ装置を経皮的に心耳に植え込む器具類を提供する。フィルタ装置は、心耳内で形成された血餅が身体の血液循環系内へ分散することを防ぐために設計される。
左心耳(LAA)とその関連心房との間の血流をろ過あるいは変更するための装置をLAA内に植え込むことができる。カテーテルアクセスシースを心臓に向かう血管を通して経皮的に進入させ、LAAへのアクセスを得る。アクセスシースを通して、装置をLAAに移動させるために送達システムを用いる。この送達システムは、インプラント装置の移動を制御するためのシャフトまたはワイヤを含む。
Claims (57)
- 心耳からの血流をろ過するための血流ろ過システムであって、該システムは、血流を遮るために心耳内に展開するように形状化されているフィルタ装置であって、該装置が拘束されていない場合は、圧縮状態からその本来のサイズへと拡張する伸縮性構造を有するフィルタ装置;
心耳への経皮的通路を設定するための管状アクセスシース;および
該アクセスシースの管腔を通して前記装置を送達し、前記送達された装置を心耳内に展開するための送達器具であって、該送達装置は、
送達管および、
該送達管を通り、また該装置に解除可能に取り付けられている移動可能なつなぎとを含む送達器具、
を含んでなり、該つなぎが前記装置の該送達および展開に対して機械的制御を提供し、また、該アクセスシースおよび該送達管が、両者の相対的な動きを制御する解除可能なロックを含んでなる、システム。 - 前記アクセスシースが、約90度の屈曲角度で遠位部分内へ湾曲している直線部分を有する管を含んでなる、請求項1に記載のシステム。
- 前記アクセスシースが、実質的に直線状の部分および第2の遠位部分を有する管を含んでなり、該実質的に直線状の部分は、第1の屈曲角度で第1の遠位部分内へ湾曲しており、そして該第2の遠位部分は、該直線の部分と該第1の遠位部分との平面に相対し、第2の屈曲角度で該第1の遠位部分から離れて湾曲している、請求項1に記載のシステム。
- 前記第1の屈曲角度が約90度である、請求項3に記載のシステム。
- 前記アクセスシースが、シースの遠位先端を身体の血管系を通して心耳内へ配置するための縦長部を有する、請求項1に記載のシステム。
- 前記つなぎワイヤが、前記フィルタ装置を回転可能に取り付けるためのねじ付き固定具を含んでなる、請求項1に記載のシステム。
- 前記取り付けられた装置に対する前記つなぎワイヤの連結剛性を減少させるために、前記ねじ付き固定具の近くの該つなぎワイヤの縦長部が、該つなぎワイヤ近位の縦長部の直径よりも実質的に小さい直径を有する、請求項6に記載のシステム。
- 前記送達管が、前記アクセスシースの前記管腔を通してのフィルタ装置送達の間、該フィルタ装置を圧縮状態に拘束する管状インプラントシースを含んでなる、請求項1に記載のシステム。
- 前記つなぎワイヤが、前記管状インプラントシースの内径よりも実質的に小さい直径を有し、該つなぎワイヤが送達管を通って移動する時、そのバックリングを避けるために、前記取り付けられたフィルタ装置に近位の該つなぎワイヤの縦長部が、より大きな直径の可撓性コイルに包まれている、請求項8に記載のシステム。
- 前記可撓性コイルが、前記管状インプラントシースの略内直径の直径を有し、該可撓性コイルが、その近位端で前記送達管の前記管腔と流体連通している管腔を含み、該可撓性コイル管腔がその遠位端付近で流出口に開いている、請求項9に記載のシステム。
- 前記送達管を前記アクセスシースの前記管腔内へ密閉可能に受容するための、該アクセスシースがその近位端にバルブアッセンブリを含んでなる、請求項1に記載のシステム。
- 前記バルブアッセンブリが、出血を抑止するように、前記受容した送達管の表面に対して調整可能に圧縮できるシールを含んでなる、請求項11に記載のシステム。
- 前記送達管と前記アクセスシースとの動きを連結させるための解除可能なロックを前記バルブアッセンブリ上に配置している、請求項11に記載のシステム。
- 前記バルブアッセンブリ上に配置した前記解除可能なロックがルアーフィッティングである、請求項13に記載のシステム。
- 前記バルブアッセンブリが、止血バルブを含んでなる、請求項11に記載のシステム。
- 前記バルブアッセンブリが、放射状圧縮バルブを含んでなる、請求項11に記載のシステム。
- 前記バルブアッセンブリが、前記アクセスシースの管腔を通る流体の通路口を含んでなる、請求項11に記載のシステム。
- 前記送達管が、その近位端に多岐管をさらに含んでなり、前記つなぎワイヤが該多岐管を動いて通ることのできる、請求項1に記載のシステム。
- 前記つなぎワイヤの近位端末端がノブで終わっており、該ノブを回すことによって、該つなぎワイヤを回転させて、該つなぎワイヤの遠位端に取り付けられている装置を取り外す、請求項18に記載のシステム。
- 前記ノブが、前記多岐管上に設置されている回転可能なノブである、請求項19に記載のシステム。
- 前記つなぎワイヤの回転および平行移動のための剛性を提供するために、前記多岐管内に伸張するつなぎワイヤの縦長部にケースが配置されている、請求項18に記載のシステム。
- 前記つなぎワイヤ上の近位末端から離れて該つなぎワイヤ上に取り外し可能な栓が配置されており、該つなぎワイヤの前記多岐管内への平行移動を制限するように、前記取り外し可能な栓が、前記多岐管に対して作用する、請求項18に記載のシステム。
- 前記ケースの縦長部が、非円形断面を有し、前記多岐管が同様の形の断面を有するキー溝を含んでなり、該キー溝が該ケースの非円形縦長部の滑りを可能にし、該ケースの非円形縦長部の回転を抑止する請求項18に記載のシステム。
- 前記ノブに隣接するつなぎワイヤの縦長部が、前記キー溝を自由に回転する実質的に円形断面を有する、請求項22に記載のシステム。
- 前記非円形断面が、D形を含む、請求項23に記載のシステム。
- 前記送達管を前記つなぎワイヤ上の前記多岐管内へ相互に引き込むために該多岐管上に滑り可能に設置されているアクチュエータをさらに含んでなる、請求項18に記載のシステム。
- 前記多岐管が、前記送達管の管腔を通る流体の通路口を含んでなる、請求項18に記載のシステム。
- 前記送達器具と前記アクセスシースの動きを連結させるための解除可能なロックが前記多岐管上に配置されており、ロックが作動している時、該アクセスシースとインプラントシースの遠位端が略同一平面上にある、請求項18に記載のシステム。
- 前記多岐管上に配置されている前記解除可能なロックが、ルアーフィッティングである、請求項28に記載のシステム。
- 前記多岐管上に配置されている前記解除可能なロックの第2の部分が、前記アクセスシースに対する該多岐管の平行移動を防ぐように、該アクセスシース上の円筒形バルブ本体を解除可能に捕捉するC形クリップである、請求項28に記載のシステム。
- 前記C形クリップが、前記アクセスシース上の前記円筒形バルブ本体を回転可能に捕捉し、該アクセスシース内における前記送達管の回転を可能にする、請求項30に記載のシステム。
- 前記フィルタ装置は、
伸縮性ワイヤフレームであって、該ワイヤフレームは閉鎖端を有し、該閉鎖端付近の該ワイヤフレームの略長手方向軸上にねじ付きソケットが配置されており、ワイヤ部分は、該ねじ付きソケット付近から該ワイヤフレームの側部へ放射状に延在し、該フィルタ装置を付勢してその本来のサイズにするスプリングとして該ワイヤ部分が作用する、ワイヤフレーム;および
該ワイヤフレームの少なくとも該閉鎖端上に配置されている血流透過性フィルタ膜、
を含んでなり、該フィルタ装置の前記閉鎖端の外面が実質的に平坦である、請求項1に記載のシステム。 - スプリングとして作用する前記ワイヤ部分がS形を有する、請求項32に記載のシステム。
- 前記ワイヤフレームは、心耳で締りばめになるような直径を有する円筒形状を有する、請求項32に記載のシステム。
- 前記円筒形状が、前記閉鎖端から先細りになっている、請求項34に記載のシステム。
- 心耳へ経中隔アクセスできるように、心房中隔に開口を作る拡張器および針をさらに含んでなる、請求項1に記載のシステム。
- 伸縮性のワイヤフレームであって、該ワイヤフレームが、心耳における締りばめになるような直径を有し、該ワイヤフレームは、圧縮時に該ワイヤフレームをその本来のサイズに付勢するためにスプリングとして働く、その長手方向から、該ワイヤフレームの側部へと放射状に伸張するワイヤ部分を含む、伸縮性ワイヤフレーム;
該ワイヤフレームの近位端の平面付近の該ワイヤフレームの長手方向軸上に配置された固定具であって、該固定具は、該装置をつなぎワイヤに取り付けるための構造を有する固定具;および
該ワイヤフレームの近位端を覆うフィルタ膜であって、該フィルタ膜は、心耳口にまたがって延在して、それを通る血流を遮り、前記装置が該ワイヤフレームの該近位端の平面に沿って実質的に平坦な外面を提供する、フィルタ膜、
を含んでなる、心耳からの血流をろ過する装置。 - 前記ワイヤ部分が実質的に浅い角度で、前記固定具付近から前記長手方向軸の方へと出ており、前記ワイヤフレームの放射平面内に位置するS形ワイヤ部分である、請求項37に記載の装置。
- 前記固定具が、管状カラー、および前記装置をつなぎワイヤへ取り付けるソケットを有する挿入具を含み、前記S形ワイヤ部分が該カラーから出ている、請求項38に記載の装置。
- 前記フィルタ膜の一部が、前記カラーと前記挿入具との間に保持されており、一方、該フィルタ膜の他の部分が、該ワイヤフレームの他の部分に取り付けられている、請求項39に記載の装置。
- 前記ワイヤフレームが金網様メッシュを含む、請求項37に記載の装置。
- 非外傷性組織接触を提供するために、前記ワイヤフレームの遠位ワイヤ端が該ワイヤフレームの前記長手方向軸向きへ放射状に内側に曲がっている、請求項41に記載の装置。
- 前記ワイヤフレームが円錐形を有する、請求項37に記載の装置。
- インプラントシース内へ伸張する送達管であって、該送達管が約30ミルから約100ミルの内直径を有し、該インプラントシースが、該インプラントシース内に含まれている圧縮状態における装置の直径よりも大きな内直径を有する送達管;
該送達管の近位端に配置された多岐管;
該多岐管を通って移動できるつなぎワイヤであって、該つなぎワイヤが該インプラントシース内に含まれる装置に取り付けられた固定具を有し、該取り付けられた装置は該送達管を通る該つなぎワイヤの縦長部の平行移動により、該インプラントシースから拡張する際にその本来のサイズへと拡張し、該装置がまだ該つなぎワイヤに取り付けられている間に心耳内に展開された時、該つなぎワイヤは、放出された装置がその本来の付勢のない状態に達することを可能にする連結剛性を有する、つなぎワイヤ、
を含んでなる自己拡張装置を心耳内に植え込むための、装置送達システム。 - 前記取り付けられた装置との前記連結剛性を減少させるために、前記固定具の近くのつなぎワイヤの縦長部が、該つなぎワイヤの近位縦長部の直径に対して相対的に小さな直径を有する、請求項44に記載の装置送達システム。
- 前記つなぎワイヤが、前記インプラントシースを通って平行移動する際に、該つなぎワイヤのバックリングを減少させるために、該インプラントシース内へ伸張する該つなぎワイヤの縦長部が可撓性コイルに包まれている、請求項44に記載の装置送達システム。
- 前記可撓性コイルは、前記送達管の管腔と流体連通し、かつ該可撓性コイルの前記遠位端近辺に開口を有する管腔を有している、請求項46に記載の装置送達システム。
- 前記送達管が、約45ミルの内直径を有し、前記つなぎワイヤの近位縦長部が約35ミルの直径を有し、前記ねじ付き固定具近辺のつなぎワイヤの縦長部がさらに短い約10ミルの直径を有する、請求項44に記載の装置送達システム。
- 操作者に制御される前記つなぎワイヤの回転および平行移動のための剛性を提供するために、遠位端付近から前記多岐管まで伸張する該つなぎワイヤの近位縦長部上にケースが配置される、請求項44に記載の装置送達システム。
- 前記つなぎワイヤの平行移動を制限するように前記多岐管に作用する解除可能な栓をさらに含む、請求項49に記載の装置送達システム。
- 前記つなぎワイヤの平行移動を可能にし、該つなぎワイヤの回転を制限するために、前記ケースの縦長部が非円形断面を有し、前記多岐管が同様の断面を有するキー溝を有する、請求項49に記載の装置送達システム。
- 前記キー溝が、D形を有する、請求項21に記載の装置送達システム。
- 前記多岐管が、ツオヒィ・ボースト(Tuohy−Borst)バルブアッセンブリを含んでなる、請求項44に記載の装置送達システム。
- 請求項44に記載の装置送達システムであって、該システムは、前記装置を心耳へ経中隔送達するためのアクセスシースをさらに含み、前記アクセスシースが、
管の前記遠位先端を経皮的に心耳近辺に配置するような複合的湾曲および長さを有する管;および密閉可能に前記送達管を該管の管腔内へ受容するために該管の近位端に配置したバルブアッセンブリを含んでなるシステム。 - 前記複合的湾曲が、約90度の第1の湾曲および第1の湾曲面から約75度離れた第2の湾曲を含んでなる、請求項54に記載の装置送達システム。
- 前記送達管と前記アクセスシースの平行移動を共に連結させるための解除可能なロッキング構造をさらに含む、請求項54に記載の装置送達システム。
- 前記解除可能なロッキング構造が、前記アクセスシースに対して前記送達管が回転運動できるように形状化されている、請求項56に記載の装置送達システム。
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-
2003
- 2003-01-24 CA CA2474324A patent/CA2474324C/en not_active Expired - Lifetime
- 2003-01-24 JP JP2003563430A patent/JP4328209B2/ja not_active Expired - Fee Related
- 2003-01-24 US US10/351,736 patent/US20030181942A1/en not_active Abandoned
- 2003-01-24 CN CNA038046334A patent/CN1638703A/zh active Pending
- 2003-01-24 EP EP03713300.6A patent/EP1469790B1/en not_active Expired - Lifetime
- 2003-01-24 WO PCT/US2003/002395 patent/WO2003063732A2/en active Application Filing
-
2015
- 2015-07-22 US US14/806,446 patent/US9883936B2/en not_active Expired - Lifetime
-
2018
- 2018-01-08 US US15/864,412 patent/US10751158B2/en not_active Expired - Lifetime
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CA2474324A1 (en) | 2003-08-07 |
US20180140412A1 (en) | 2018-05-24 |
CN1638703A (zh) | 2005-07-13 |
EP1469790B1 (en) | 2016-10-19 |
CA2474324C (en) | 2011-09-20 |
WO2003063732A2 (en) | 2003-08-07 |
JP2005515830A (ja) | 2005-06-02 |
US9883936B2 (en) | 2018-02-06 |
WO2003063732A3 (en) | 2003-11-27 |
US20160051358A1 (en) | 2016-02-25 |
US10751158B2 (en) | 2020-08-25 |
EP1469790A2 (en) | 2004-10-27 |
US20030181942A1 (en) | 2003-09-25 |
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