JP2013523329A - 再捕獲機能を持つ経カテーテル補綴心臓弁送達システムおよび方法 - Google Patents
再捕獲機能を持つ経カテーテル補綴心臓弁送達システムおよび方法 Download PDFInfo
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- A—HUMAN NECESSITIES
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- A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
- A61F2/02—Prostheses implantable into the body
- A61F2/24—Heart valves ; Vascular valves, e.g. venous valves; Heart implants, e.g. passive devices for improving the function of the native valve or the heart muscle; Transmyocardial revascularisation [TMR] devices; Valves implantable in the body
- A61F2/2427—Devices for manipulating or deploying heart valves during implantation
- A61F2/2436—Deployment by retracting a sheath
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
- A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
- A61F2/02—Prostheses implantable into the body
- A61F2/24—Heart valves ; Vascular valves, e.g. venous valves; Heart implants, e.g. passive devices for improving the function of the native valve or the heart muscle; Transmyocardial revascularisation [TMR] devices; Valves implantable in the body
- A61F2/2412—Heart valves ; Vascular valves, e.g. venous valves; Heart implants, e.g. passive devices for improving the function of the native valve or the heart muscle; Transmyocardial revascularisation [TMR] devices; Valves implantable in the body with soft flexible valve members, e.g. tissue valves shaped like natural valves
- A61F2/2418—Scaffolds therefor, e.g. support stents
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
- A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
- A61F2/02—Prostheses implantable into the body
- A61F2/24—Heart valves ; Vascular valves, e.g. venous valves; Heart implants, e.g. passive devices for improving the function of the native valve or the heart muscle; Transmyocardial revascularisation [TMR] devices; Valves implantable in the body
- A61F2/2427—Devices for manipulating or deploying heart valves during implantation
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
- A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
- A61F2/02—Prostheses implantable into the body
- A61F2/24—Heart valves ; Vascular valves, e.g. venous valves; Heart implants, e.g. passive devices for improving the function of the native valve or the heart muscle; Transmyocardial revascularisation [TMR] devices; Valves implantable in the body
- A61F2/2427—Devices for manipulating or deploying heart valves during implantation
- A61F2/243—Deployment by mechanical expansion
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
- A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
- A61F2/95—Instruments specially adapted for placement or removal of stents or stent-grafts
- A61F2/9517—Instruments specially adapted for placement or removal of stents or stent-grafts handle assemblies therefor
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
- A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
- A61F2/95—Instruments specially adapted for placement or removal of stents or stent-grafts
- A61F2002/9534—Instruments specially adapted for placement or removal of stents or stent-grafts for repositioning of stents
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- Transplantation (AREA)
- Oral & Maxillofacial Surgery (AREA)
- Vascular Medicine (AREA)
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Abstract
【選択図】図3D
Description
Claims (15)
- ステント補綴心臓弁を経皮的に配備するための送達システムであって、
補綴心臓弁を選択的に係合させるように構成された連結構造を提供する中間部分を含む内側シャフトアセンブリと、
前記内側シャフトアセンブリ上にスライド可能に配置され、前記連結構造と係合した補綴心臓弁を収縮状態で収容するように構成された送達シースカプセルと、
前記内側シャフトアセンブリおよび前記送達シースカプセルに連結したハンドルであって、前記補綴心臓弁を引込めて前記送達システム内への前記補綴心臓弁の再捕獲を促進するように、前記遠位シースカプセルへ力を選択的に適用する第一作動装置と、前記内側シャフトアセンブリに選択的に力を適用する第二作動装置を保持するハンドルと、を備えている、
ことを特徴とする送達システム。 - 前記システムが、前記カプセルが前記内側シャフトアセンブリ上で前記ステント補綴心臓弁を収縮状態で保持する装填状態を提供するように構成されている、
請求項1に記載のシステム。 - 前記システムが、部分的に展開された状態を提供するように構成され、該部分的に展開された状態では、
前記第一作動装置が、前記送達シースカプセルに近位方向の力を提供し前記補綴心臓弁の遠位領域を露出させるように操作される、
請求項2に記載のシステム。 - 前記システムは、前記システムが前記部分的に展開された状態の後に、前記部分的に展開された状態から前記再捕獲状態への移行が、前記第二作動装置が前記補綴心臓弁へ近位方向の力を適用するように操作され、それによって、前記送達シースカプセルが、前記補綴心臓弁上にスライドし、前記補綴心臓弁を収縮させ、前記送達システム内に保持する再捕獲状態を提供するように構成されている、
請求項3に記載のシステム。 - 前記部分的に展開された状態から前記再捕獲状態への移行が、前記送達シースカプセルへの遠位方向の力を適用するように前記第一作動装置が操作されることをさらに含む、
請求項4に記載のシステム。 - 前記ハンドルが、ハウジングをさらに含み、前記第一作動装置が、前記送達シースカプセルに力を適用するように前記ハウジングに対して操作され、前記第二作動装置が、前記内側シャフトアセンブリへ力を適用するために前記ハウジングに対して移動する、
請求項1に記載のシステム。 - 前記ハウジングが、近位端と遠位端を含み、前記第一作動装置は、前記送達シースカプセルへ近位方向の力を適用するように近位端に向かって操作され、前記第二作動装置は、前記補綴心臓弁へ近位方向の力を適用するように前記近位端から離れるように操作される、
請求項6に記載のシステム。 - 患者の心臓弁を修復するためのデバイスであって、
連結構造を提供する中間部分を含む内側シャフトアセンブリと、
前記内側シャフトアセンブリ上にスライド可能に配置される送達シースカプセルと、
前記内側シャフトセンブリ、および前記送達シースカプセルに連結されるハンドルであって、前記送達シースカプセルに連結した第一作動装置および前記内側シャフトアセンブリに連結した第二作動装置を維持するハンドルと、
フレーム、および前記フレームに結合した弁構造を有し、少なくとも2つの弁小葉を形成する補綴心臓弁であって、収縮状態から初期状態へ自己拡張可能である、補綴心臓弁と、を含む送達システムを備え、前記デバイスが、
前記補綴心臓弁が前記連結構造と係合し、前記カプセル部分内に収縮状態で保持される装填状態と、
前記カプセルが前記第一作動装置の操作において前記補綴心臓弁から少なくとも部分的に退避し、前記補綴心臓弁の遠位領域が前記カプセルに対して露出され、自己拡張する部分的に展開された状態と、
前記補綴心臓弁が、前記補綴心臓弁へ近位方向の力を送達するために、前記第二作動装置の操作において前記送達システム内に引込められた再捕獲状態と、
の間で移行可能であるように構成されている、
ことを特徴とするデバイス。 - 前記再捕獲状態への移行は、前記送達シースカプセルへ遠位方向の力を適用するように前記第一作動装置が操作されることをさらに含む、
請求項8に記載のデバイス。 - 前記ハンドルが、ハウジングをさらに含み、前記送達シースカプセルに力を適用するように前記ハウジングに対して前記第一作動装置が操作され、前記内側シャフトアセンブリに力を適用するように前記ハウジングに対して前記第二作動装置が移動する、
請求項8に記載のデバイス。 - 前記ハンドルが、近位端と遠位端を含み、前記第一作動装置は、前記送達シースカプセルへ近位方向の力を適用するように前記近位端に向かって操作され、前記第二作動装置は、前記補綴心臓弁へ近位方向の力を適用するように前記近位端より離れるように操作される、
請求項10に記載のデバイス。 - 移植部位にステント補綴心臓弁を配備する方法であって、
弁構造が取り付けられたフレームを有する半径方向拡張可能補綴心臓弁が装填された送達システムを受け入れることであって、前記送達システムが、前記システムの装填された状態で、内側シャフトアセンブリ上の収縮状態中、前記補綴心臓弁を含む送達シースカプセルを含む受け入れるステップと、
収縮状態中の前記補綴心臓弁を、患者の身体内腔を通して、前記装填状態の前記送達システムを介して移植部位へ送達するステップと、
前記補綴心臓弁の遠位領域が前記カプセルの遠位で露出されるように、前記補綴心臓弁に対して、前記送達シースカプセルを近位側に退避させることであって、前記遠位領域が展開された状態に向かって自己拡張するステップと、
前記移植部位に対する前記補綴心臓弁の位置を評価するステップと、
前記補綴心臓弁の前記遠位領域が、前記カプセル内の前記折りたたみ状態に向かう移行を引き起こすように前記送達システムが前記補綴心臓弁上に配置されるように、前記内側シャフトアセンブリに近位方向の力を適用することによって、前記送達システムに対して、前記補綴心臓弁を近位方向に前進させるステップと、
前記補綴心臓弁が、前記内側シャフトアセンブリから自己展開するように、前記補綴心臓弁から前記再捕獲アセンブリを完全に近位側に引込めるステップと、を備えている、
ことを特徴とする方法。 - 遠位方向の力を前記送達シースカプセルに適用して、前記カプセルを補綴心臓弁の遠位領域上に配置し、前記折りたたみ状態に向かって移行させることをさらに含む、
請求項12に記載の方法。 - 前記送達システムが、ハウジングを有するハンドルを含み、
該ハウジングが、前記送達シースカプセルに力を適用するように前記ハウジングに対して操作可能な第一作動装置と、前記内側シャフトアセンブリに力を適用するように前記ハウジングに対して操作可能な第二作動装置を保持している、
請求項12に記載の方法。 - 前記ハウジングが、近位端および遠位端を含み、前記第一作動装置は、前記送達シースカプセルへ近位方向の力を適用するように前記近位端に向かって操作され、前記第二作動装置は、前記補綴心臓弁へ近位方向の力を適用するように前記近位端から離れるように操作される、請求項14に記載の方法。
Applications Claiming Priority (3)
Application Number | Priority Date | Filing Date | Title |
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US12/757,138 US8998980B2 (en) | 2010-04-09 | 2010-04-09 | Transcatheter prosthetic heart valve delivery system with recapturing feature and method |
US12/757,138 | 2010-04-09 | ||
PCT/US2011/029811 WO2011126758A1 (en) | 2010-04-09 | 2011-03-24 | Transcatheter prosthetic heart valve delivery system with recapturing feature and method |
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JP2013523329A true JP2013523329A (ja) | 2013-06-17 |
JP2013523329A5 JP2013523329A5 (ja) | 2014-05-08 |
JP5803041B2 JP5803041B2 (ja) | 2015-11-04 |
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US (4) | US8998980B2 (ja) |
EP (3) | EP2555710B1 (ja) |
JP (1) | JP5803041B2 (ja) |
CN (1) | CN102883683B (ja) |
AU (1) | AU2011238752B2 (ja) |
DK (1) | DK2555710T3 (ja) |
WO (1) | WO2011126758A1 (ja) |
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JP5803041B2 (ja) | 2015-11-04 |
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