JP2005525137A - 中隔欠損閉鎖のためのニードル装置および方法 - Google Patents
中隔欠損閉鎖のためのニードル装置および方法 Download PDFInfo
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Abstract
Description
本発明は、概して中隔欠損症を処置するための方法ならびに装置に関し、より詳細には、ニードル・デバイスを使用して、卵円孔開存もしくはそのほかの組織弁を含む中隔欠損を閉鎖するための装置ならびに方法に関する。
子宮内の胎児の発育の間においては、発育中の胎児の肺ではなく、概して母親の胎盤によって血液の酸素化が行われる。胎児の循環のほとんどは、肺から離れ、特殊な脈管または小孔を介してシャントされ、この小孔は、胎児期の間にわたって開いているが、一般には出生直後に閉じられる。しかしながら、まれに、これらの小孔が閉じられずに残って血流力学上の問題を招き、最終的にはそれが、処置しなければ致命的になることもある。
本発明は、卵円孔開存(「PFO」)、動脈管開存症(「PDA」)あるいはそのほかの中隔欠損を閉鎖するための装置ならびに方法に関する。
ここで図面を参照すると、図1および2には、本発明に従ってPFOまたはPDA等の中隔欠損を閉鎖するための装置10の第1の好ましい実施形態が示されている。概して、装置10は、ニードル装置12、およびニードル装置12の導入ならびに展開を行うための送達装置50を備える。
Claims (40)
- 中隔欠損を閉鎖するための装置であって、該装置は、以下:
組織侵入チップを規定する第1端部、および実質的なブラントチップを規定する第2端部を備える細長いニードル;
該ニードルの、該第1端部と該第2端部との間の中間部分から延びるフィラメント;および、
該フィラメントに固定可能なロッキング要素であって、それによってロッキング要素が該フィラメントに沿って前記ニードルから離れて移動するのが防止されるロッキング要素;
を備える、装置。 - 前記ニードルは、前記第2端部が実質的に前記第1端部より大きくなるようにテーパーが付けられた断面を有する、請求項1に記載の装置。
- 前記ニードルは、その中に、前記中間部分から前記第2端部に延びるスロットを備え、該スロットは、その中に前記フィラメントの一部を受け入れるためのサイズを有する、請求項1に記載の装置。
- 前記フィラメントは、前記ニードルの前記中間部分に旋回可能に連結される、請求項1に記載の装置。
- 前記ニードルの前記中間部分は、ホールを備え、該ホールを通って前記フィラメントが該ニードルに実質的に固定される、請求項1に記載の装置。
- 前記ロッキング要素は、前記フィラメントに沿って前記ニードルに向かうスライド可能なクリップを備え、該クリップは、該フィラメントに沿って該ニードルから該クリップが離れる移動を防止するための係合エレメントを備える、請求項1に記載の装置。
- 請求項1に記載の装置であって、該装置は、さらに以下:
近位端部および遠位端部、ならびにそれらの間に管腔を有する管状部材であって、該遠位端部は、血管内へ挿入するためのサイズを有し、前記ニードルは、前記第1端部が前記第2端部より遠位側に配置されるように前記管腔内に運ばれる、管状部材;ならびに
前記管腔内にスライド可能に配置されるプッシャ部材であって、該プッシャ部材は、該ニードルの該第2端部の近位に配置される遠位端部を備え、かつ該ニードルを該管腔から遠位側に排出するために該管状部材に対して相対的に軸方向に移動可能であるプッシャ部材;
を備える、装置。 - 前記プッシャ部材は、該プッシャ部材の前記遠位端部から近位方向に延びる管腔を備え、前記フィラメントが該管腔内を通って受け入れられている、請求項7に記載の装置。
- 前記プッシャ部材の前記遠位端部が、前記管状部材の前記遠位端部を所定距離だけ越えて伸びるように、該管状部材に対して相対的に該プッシャ部材を前進させるために、該管状部材の近位端部上にアクチュエータを備える、請求項8に記載の装置。
- 前記ニードルの前記第2端部は、前記プッシャ部材の前記遠位端部の断面より実質的に大きい断面を有する、請求項9に記載の装置。
- 前記ニードルの前記第2端部は、該第2端部が前記プッシャ部材の前記遠位端部から横方向に広がるようなフレア付き外側エッジを備える、請求項10に記載の装置。
- 前記アクチュエータは、前記プッシャ部材が前記所定距離を前進した後に、前記フィラメントを近位側に引くために該フィラメントに連結されている、請求項9に記載の装置。
- 前記ニードルの前記第2端部は、前記フィラメントが近位側に引かれたとき、前記中間領域の周りに前記ニードルが旋回するのを促進するために、丸み付きのエッジを備える、請求項12に記載の装置。
- 請求項1に記載の装置であって、該装置はさらに、身体管腔内への導入のためのサイズを有する近位端部および遠位端部を有するキャリア部材を備え、前記ロッキング要素は、該キャリア部材の該遠位端部によって解放可能に運ばれる、装置。
- 前記ロッキング要素は対向するアームを備え、前記対向するアームは、該アームの間に前記フィラメントを中に受け入れるための空間を規定し、前記キャリア部材は、該対向するアームの少なくとも一方を可塑的に変形させて、該フィラメントに摩擦係合させるためのハンマー構成を備える、請求項14に記載の装置。
- さらに、前記管状部材の前記遠位端部を越えて、画像化を行うための該管状部材の該遠位端部に関連付けされた画像化要素を備える画像化デバイスを備える、請求項1に記載の装置。
- 前記画像化デバイスは、前記管状部材の管腔内に受け入れられる内視鏡を含む、請求項16に記載の装置。
- 前記画像化デバイスは、身体管腔内への導入のためのサイズを有する遠位端部を備える細長い部材を備える、請求項16に記載の装置。
- 患者の心臓内の中隔欠損を閉鎖するための方法であって、該中隔欠損が、該心臓の第1チャンバと第2のチャンバとの間の隔壁から部分的に分離した組織弁を含み、該組織弁および周囲組織が、該隔壁を通る中隔開口を規定する中隔欠損を閉鎖するための方法であって、該方法は、以下の工程:
組織侵入チップを規定する第1端部、実質的なブラントチップを規定する第2端部、および該第1端部と該第2端部との間の、そこからフィラメントが延びる中間部分を含むニードルを用意する工程;
該ニードルが該中隔開口に隣接する該心臓の該第1のチャンバ内に配置されるまで、該患者の脈管構造を介して該ニードルを前進させる工程;
該第2端部が該組織弁を貫通し、該ニードルが該心臓の該第2のチャンバ内に配置されるまで、該組織弁を通して該ニードルの該第1端部を送り出す工程;
該フィラメントを引き、それによって該中間領域の周りに前記ニードルを旋回させ、その結果、該ニードルの該第1端部および該第2端部が該第2のチャンバ内において該中隔開口をまたぐようにする工程;ならびに
該組織弁を方向付けて該隔壁と係合させ、該中隔開口を少なくとも部分的に閉鎖する工程;
を包含する、方法。 - 前記組織弁を方向付ける工程は、前記フィラメントに前記ロッキング要素を固定する工程を包含し、該ロッキング要素は、該組織弁の近位側表面に係合して、前記ニードルと該ロッキング要素のと間に該組織弁を固定する工程を包含する、請求項19に記載の方法。
- 前記ロッキング要素を固定する工程は、前記心臓の前記第1のチャンバ内へキャリア部材を導入する工程を包含し、該キャリア部材は、前記ロッキング要素を運ぶ、請求項20に記載の方法。
- 前記キャリア部材が操作されて、前記ロッキング要素のスロット内に前記フィラメントが受け入れられ、前記ロッキング要素は、クリンプされて、前記スロット内の前記フィラメントを固定する、請求項20に記載の方法。
- ロッキング要素は、前記フィラメント上にスライド可能に固定されるクリップを備える、請求項19に記載の方法。
- 前記組織弁を方向付ける工程は、該組織弁が前記中隔開口を取り囲む前記組織に対して固定されるまで、前記フィラメントに沿って前記ニードルに向かって前記クリップを前進する工程を包含する、請求項19に記載の方法。
- 前記フィラメントを引く工程は、前記組織弁の遠位側表面に沿って前記ニードルの前記ブラントチップをスライド可能に係合させ、それによって該ニードルの中間領域の周りに該ニードルを旋回させる工程を包含する、請求項19に記載の方法。
- 前記ニードルの前記ブラントチップは、前記遠位側表面に沿った前記ニードルの動きを促進するための丸みを帯びた内側エッジを備える、請求項25に記載の方法。
- 前記ニードルは、互いにスライド可能に連結されたカテーテルおよびプッシャ部材を備える送達装置の遠位端部内に配置され、該ニードルを前進させる工程は、該遠位端部が前記組織弁に隣接して配置されるまで、該送達装置の該遠位端部を前記第1のチャンバ内へ前進させる工程を包含する、請求項19に記載の方法。
- 前記組織弁を通して前記ニードルの前記第1端部を送り出す工程は、前記プッシャ部材を前記カテーテルに対して相対的に遠位方向に前進させ、それによって前記送達装置内から前記ニードルを送り出す工程を包含する、請求項27に記載の方法。
- 中隔欠損を閉鎖するための装置であって、該装置は、以下:
組織侵入チップを規定する第1端部、実質的なブラントチップを規定する第2端部、ならびに該第1端部および該第2端部との間に延びる長手方向の軸を備える、細長いニードル;および
該第1端部と該第2端部の間の該ニードルの中間部分から延びるフィラメントであって、該フィラメントの少なくとも1つのセグメントが、該長手方向の軸に対してほぼ平行に広がる平面を規定する構成に向かって付勢されており、該フィラメントは、ほぼ直線状の構成に向かって弾性的に拡げることが可能である、フィラメント、
を備える、装置。 - 前記ニードルは、前記第2端部が前記第1端部より実質的に大きくなるようにテーパーが付けられた断面を有する、請求項29に記載の装置。
- 前記ニードルは、その中に、前記中間部分から前記第2端部に延びるスロットを有し、前記スロットは、その中に前記フィラメントの一部を受け入れるためのサイズを有する、請求項29に記載の装置。
- 前記フィラメントは、第1セグメントおよび第2セグメントを含み、該第1セグメントは、前記ニードルの前記中間部分に取り付けられており、かつ前記長手方向の軸に関して交差方向に延びるように付勢されており、該第2セグメントは、該第1セグメントから延び、該第2のセグメントが平面を規定するように該第1セグメントに対して交差方向に延びるように付勢されている、請求項29に記載の装置。
- 前記第2のセグメントは、コイル状の構成に向かって付勢されており、該コイル状の構成は、実質的に該平面内に広がる、請求項32に記載の装置。
- 前記第2のセグメントは、実質的に前記平面内に広がる平面的な構成に向かって付勢されている、請求項32に記載の装置。
- 前記平面的な構成は、実質的に前記平面内に広がる「L」、「U」、「Y」、および「S」字形状のうちの少なくとも1つを含む、請求項34に記載の装置。
- 請求項29に記載の装置であって、該装置は、さらに以下:
近位端部および遠位端部、ならびにそれらの間に管腔を備える管状部材であって、該遠位端部は、血管内へ挿入するためのサイズを有し、前記第1端部が前記第2端部に対して遠位側に配置されるように、前記ニードルが該管腔内を運ばれる、管状部材;ならびに
前記管腔内にスライド可能に配置されるプッシャ部材であって、該プッシャ部材は、該ニードルの該第2端部の近位に配置される遠位端部を備え、かつ該ニードルを該管腔から遠位側に排出するために、該管状部材に対して相対的に軸方向に移動可能である、プッシャ部材;
を備える、装置。 - 前記プッシャ部材は、前記フィラメントの自由端を解放可能に固定し、それによって前記フィラメントをほぼ直線的な構成に拘束するためのグリップ機構を備える、請求項36に記載の装置。
- さらに、前記フィラメントの前記自由端を解放するために、前記プッシャ部材の近位端部上にアクチュエータを備え、その結果、該フィラメントが付勢されて前記平面的な構成を呈する、請求項37に記載の装置。
- さらに、前記管状部材の前記遠位端部を越えて、画像化を行うための該管状部材の該遠位端部に関連付けされた画像化要素を備える、請求項36に記載の装置。
- 患者の心臓内の中隔欠損を閉鎖するための方法であって、前記中隔欠損が、該心臓の第1チャンバと第2チャンバとの間の隔壁から部分的に分離した組織弁を含み、該組織弁および周囲組織は、該隔壁を貫通して中隔開口を規定し、該方法は、以下の工程:
組織侵入チップを規定する第1端部、実質的なブラントチップを規定する第2端部、および前記第1および第2端部の間の、そこからフィラメントが延びる中間部分、を備えるニードルを用意する工程;
前記ニードルが前記中隔開口に隣接する該心臓の該第1のチャンバ内に配置されるまで、該患者の脈管構造を介して該ニードルを前進させる工程;
該第2端部が該組織弁を貫通し、該ニードルが該心臓の該第2のチャンバ内に配置されるまで、該組織弁を通して該ニードルの該第1端部を送り出す工程;
該フィラメントを引き、それによって該中間領域の周りに該ニードルを旋回させ、該ニードルの該第1端部および該第2端部が該第2のチャンバ内において該中隔開口をまたぐようにする工程;ならびに
該フィラメントを解放し、それによって該フィラメントが弾力的にほぼ平面的な構成を呈し、それによって該ニードルと該フィラメントの間に該組織弁を係合して、該中隔開口を少なくとも部分的に閉鎖する工程;
を包含する、方法。
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Application Number | Priority Date | Filing Date | Title |
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US09/948,453 US6702835B2 (en) | 2001-09-07 | 2001-09-07 | Needle apparatus for closing septal defects and methods for using such apparatus |
PCT/US2002/028252 WO2003022160A1 (en) | 2001-09-07 | 2002-09-04 | Needle apparatus and methods for closing septal defects |
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JP2005525137A true JP2005525137A (ja) | 2005-08-25 |
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US (5) | US6702835B2 (ja) |
EP (1) | EP1423052B1 (ja) |
JP (1) | JP2005525137A (ja) |
AT (1) | ATE494840T1 (ja) |
CA (1) | CA2459709A1 (ja) |
DE (1) | DE60238923D1 (ja) |
WO (1) | WO2003022160A1 (ja) |
Cited By (6)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
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-
2001
- 2001-09-07 US US09/948,453 patent/US6702835B2/en not_active Expired - Fee Related
-
2002
- 2002-09-04 DE DE60238923T patent/DE60238923D1/de not_active Expired - Lifetime
- 2002-09-04 CA CA002459709A patent/CA2459709A1/en not_active Abandoned
- 2002-09-04 JP JP2003526292A patent/JP2005525137A/ja active Pending
- 2002-09-04 EP EP02798128A patent/EP1423052B1/en not_active Expired - Lifetime
- 2002-09-04 AT AT02798128T patent/ATE494840T1/de not_active IP Right Cessation
- 2002-09-04 WO PCT/US2002/028252 patent/WO2003022160A1/en active Application Filing
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2003
- 2003-12-11 US US10/734,670 patent/US8070826B2/en not_active Expired - Fee Related
-
2011
- 2011-10-25 US US13/281,235 patent/US20120041482A1/en not_active Abandoned
-
2012
- 2012-11-16 US US13/679,945 patent/US8747483B2/en not_active Expired - Fee Related
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2014
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JP2006304928A (ja) * | 2005-04-27 | 2006-11-09 | Nippon Sherwood Medical Industries Ltd | 臓器固定具および臓器固定具セット |
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JP2009521266A (ja) * | 2005-12-23 | 2009-06-04 | コーディス・コーポレイション | 血管創傷を閉じるためのシステム |
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JP2010148546A (ja) * | 2008-12-24 | 2010-07-08 | Hoya Corp | 内視鏡用縫合器具 |
JP2015516245A (ja) * | 2012-05-16 | 2015-06-11 | イェーナヴァルヴ テクノロジー ゲゼルシャフト ミット ベシュレンクテル ハフツング | 拡張可能心臓代用弁を導入するためのカテーテル送達システムおよび心臓弁欠陥の治療のための医療デバイス |
Also Published As
Publication number | Publication date |
---|---|
US8747483B2 (en) | 2014-06-10 |
US20030050665A1 (en) | 2003-03-13 |
US20140243889A1 (en) | 2014-08-28 |
DE60238923D1 (de) | 2011-02-24 |
EP1423052A1 (en) | 2004-06-02 |
CA2459709A1 (en) | 2003-03-20 |
ATE494840T1 (de) | 2011-01-15 |
US20120041482A1 (en) | 2012-02-16 |
EP1423052B1 (en) | 2011-01-12 |
US8070826B2 (en) | 2011-12-06 |
WO2003022160A1 (en) | 2003-03-20 |
US6702835B2 (en) | 2004-03-09 |
US20040127917A1 (en) | 2004-07-01 |
US20130072966A1 (en) | 2013-03-21 |
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