JP2013527010A - 補綴心臓弁の制御された拡張収縮を利用したカテーテル経由移送システム及び方法 - Google Patents
補綴心臓弁の制御された拡張収縮を利用したカテーテル経由移送システム及び方法 Download PDFInfo
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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
- A61F2/2436—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
- A61F2/2439—Expansion controlled by filaments
-
- 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
- A61F2002/9505—Instruments specially adapted for placement or removal of stents or stent-grafts having retaining means other than an outer sleeve, e.g. male-female connector between stent and instrument
-
- 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
- A61F2/962—Instruments specially adapted for placement or removal of stents or stent-grafts having an outer sleeve
- A61F2/966—Instruments specially adapted for placement or removal of stents or stent-grafts having an outer sleeve with relative longitudinal movement between outer sleeve and prosthesis, e.g. using a push rod
- A61F2002/9665—Instruments specially adapted for placement or removal of stents or stent-grafts having an outer sleeve with relative longitudinal movement between outer sleeve and prosthesis, e.g. using a push rod with additional retaining means
-
- 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
- A61F2230/00—Geometry of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof
- A61F2230/0002—Two-dimensional shapes, e.g. cross-sections
- A61F2230/0028—Shapes in the form of latin or greek characters
- A61F2230/005—Rosette-shaped, e.g. star-shaped
-
- 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
- A61F2230/00—Geometry of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof
- A61F2230/0002—Two-dimensional shapes, e.g. cross-sections
- A61F2230/0028—Shapes in the form of latin or greek characters
- A61F2230/0054—V-shaped
-
- 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
- A61F2230/00—Geometry of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof
- A61F2230/0063—Three-dimensional shapes
- A61F2230/0073—Quadric-shaped
- A61F2230/008—Quadric-shaped paraboloidal
Abstract
【選択図】 図4
Description
本発明は、「補綴心臓弁人の制御された拡張収縮を利用したカテーテル経由移送システム及び方法」という表題で2010年6月2日に出願され、弁理士事件整理番号No.P0035394.00を有する米国仮特許出願第61/350,656に対する米国特許法35条, 119(e)(1)に基づく優先権を宣言し、これにより全教示を本願明細書に組み込む。
Claims (24)
- 弁構造が取り付けられるステントフレームを有する補綴心臓弁と共に使用される移送システムであって、
遠位端と該遠位端の近くに配置され前記補綴心臓弁の遠位端に結合されるように構成された結合構造とを有しているシャフトアセンブリと、
前記シャフトアセンブリを摺動可能に受け入れられるようなサイズの内腔を有するシースアセンブリ、とを備え、
前記移送システムが、前記シースアセンブリが前記補綴心臓弁を取り囲んでいる装填状態から前記シースアセンブリが前記補綴心臓弁から後退させられた展開状態に移行するように構成され、さらに、前記結合構造が前記シャフトアセンブリの遠位端の長手方向の動きに基づいて前記補綴心臓弁の遠位端を制御された状態で拡張あるいは収縮させるように構成されている、
ことを特徴とする移送システム。 - 前記結合構造が第1方向に動かされて前記補綴心臓弁の遠位端を制御された状態で拡張させるように構成されており、さらに、前記結合構造が前記第1方向の反対の第2方向に動かされて前記補綴心臓弁の遠位端を制御された状態で収縮させるように構成されている、
請求項1に記載の移送システム。 - 前記第1方向が近位方向であり、前記第2方向が遠位方向である、
請求項2に記載の移送システム。 - 前記シャフトアセンブリが、その遠位端に配置されたノーズコーンを有し、さらに、前記結合構造が前記ノーズコーンの近位端に配置されている、
請求項1に記載の移送システム。 - 前記結合構造が前記ノーズコーンに摺動可能に取り付けられ、さらに、前記結合構造とノーズコーンが相互に長手方向に摺動できるように構成されている、
請求項4に記載の移送システム。 - 前記結合構造が溝を含んでおり、前記ノーズコーンが前記溝内部に配置されるように構成された特徴部分を含んでおり、さらに、前記溝と前記特徴部分が、前記結合構造がそのノーズコーンに対して摺動した時にそれを誘導するように構成されている、
請求項5に記載の移送システム。 - 前記ノーズコーンが第1方向に動かされて前記結合構造を作動させて前記補綴心臓弁の遠位端を制御された状態で拡張させるように構成されており、さらに、前記ノーズコーンが前記第1方向とは反対の第2方向に動かされて結合構造を作動させて前記補綴心臓弁の遠位端を制御された状態で収縮させるように構成されている、
請求項5に記載の移送システム。 - 前記第1方向が遠位方向であり、前記第2方向が近位方向である、
請求項7に記載の移送システム。 - 前記結合構造が、前記補綴心臓弁が閾値量を超えて拡張した場合に、前記補綴心臓弁の遠位端から自動的にリリースされるように構成されていることを特徴とする、
請求項1に記載の移送システム。 - 前記結合構造が形状記憶素材でつくられている、
請求項1に記載の移送システム。 - 前記結合構造がニチノールでつくられている、
請求項10に記載の移送システム。 - 前記結合構造がポリマーでつくられている、
請求項1に記載の移送システム。 - 前記結合構造が縫合用素材でつくられている、
請求項1に記載の移送システム。 - 前記結合構造が筒状のベース部分とその筒状のベース部分から延びた複数の脚を有している、
請求項1に記載の移送システム。 - 前記脚は、それぞれが、前記補綴心臓弁の遠位端上のフックに取り外し可能に結合できるように構成されているループ形状の端部部分を含んでいる、
請求項14に記載の移送システム。 - 前記補綴心臓弁の遠位端が前記補綴心臓弁の流入端である、
請求項1に記載の移送システム。 - 前記補綴心臓弁の遠位端が前記補綴心臓弁の流出端である、
請求項1に記載の移送システム。 - 患者の欠陥のある心臓弁に治療処置を行うシステムであって、
移送システムを備え、該移送システムが、
遠位端と該遠位端の近くに配置され前記補綴心臓弁の遠位端に結合されるように構成された結合構造とを有するシャフトアセンブリと、
前記シャフトアセンブリを摺動可能に受け入れることが出来る内腔を有するシースアセンブリを含むシャフトアセンブリと、
ステントフレームと、該ステントフレームに取り付けられ少なくとも2枚の弁小葉を形成する弁構造を形成する収縮された態様から初期態様に自己展開する補綴心臓弁、とを備え、
前記移送システムが前記シースアセンブリ内に前記補綴心臓弁を摺動可能に受け入れることができるように構成されていると共に、前記シースアセンブリが前記補綴心臓弁を取り囲んでいる装填状態から、前記シースアセンブリが前記補綴心臓弁から引き出されている展開状態に移行するように作動して、前記補綴心臓弁が初期態様に自己拡張して前記移送システムからリリースされるように構成されており、さらに、前記結合構造が前記シャフトアセンブリの遠位端の第1方向への長手方向の動きに基づいて前記補綴心臓弁の遠位端が制御された状態で拡張し、さらに、前記シャフトアセンブリの遠位端の前記第1方向とは反対向きの第2長手方向への動きに基づいて前記補綴心臓弁の遠端を制御された状態で収縮するように構成されている、
ことを特徴とするシステム。 - 前記第1方向が遠位方向であり、前記第2方向が近位方向である、
請求項18に記載のシステム。 - 前記第1方向が近位方向であり、前記第2方向は遠位方向である、
請求項18に記載のシステム。 - 前記シャフトアセンブリがさらにそのシャフトアセンブリの遠位端に配置されたノーズコーンを含んでおり、そして、前記結合構造が摺動可能に前記ノーズコーンに取り付けられている、
請求項18に記載のシステム。 - 前記結合構造が、前記補綴心臓弁が閾値量を超えて拡張した場合に、前記補綴心臓弁の遠位端から自動的にリリースされるように構成されている、
請求項18に記載のシステム。 - 患者の欠陥のある心臓弁に治療処置を行う方法であって、
弁構造が取り付けられるステントフレームを有する自己拡張性の補綴心臓弁を装填された移送システムを受け入れるステップで、前記移送システムが移送用シース内に摺動可能に配置されるシャフトアセンブリと含んでおり、前記シャフトアセンブリがそのシャフトアセンブリの遠位端近くに配置されており前記補綴心臓弁の遠位端に結合される結合構造を含んでいて前記移送用シースが前記補綴心臓弁を収縮された体勢で含んでいることを特徴とするステップと、
前記移送システムを操作して前記補綴心臓弁をその患者の脈管構造を通じて前記欠陥を有する心臓弁内に誘導するステップと、
前記移送シースを前記補綴心臓弁から引き出すステップと、
前記シャフトアセンブリの遠位端を第1長手方向に動かして前記結合構造が前記補綴心臓弁の遠位端を制御された状態で拡張するようにさせるステップと、そして、
前記補綴心臓弁を前記移送システムからリリースするステップ、を備えている、
ことを特徴とする方法。 - さらに、制御された状態での拡張を行った後、補綴心臓弁の位置を評価するステップと、
前記シャフトアセンブリの遠位端を第2の長手方向に動かして、前記結合構造が補綴心臓弁の制御された状態での収縮を行わせるステップと、そして
前記制御された状態での収縮を行った後に、前記移送システムを操作して前記補綴心臓弁の位置調整を行うステップ、を備えている、
請求項23に記載の方法。
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US35065610P | 2010-06-02 | 2010-06-02 | |
US61/350,656 | 2010-06-02 | ||
PCT/US2011/038715 WO2011153210A1 (en) | 2010-06-02 | 2011-06-01 | Transcatheter delivery system and method with controlled expansion and contraction of prosthetic heart vavle |
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JP2013527010A5 JP2013527010A5 (ja) | 2014-07-17 |
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US10595994B1 (en) | 2018-09-20 | 2020-03-24 | Vdyne, Llc | Side-delivered transcatheter heart valve replacement |
US11071627B2 (en) | 2018-10-18 | 2021-07-27 | Vdyne, Inc. | Orthogonally delivered transcatheter heart valve frame for valve in valve prosthesis |
US11076956B2 (en) | 2019-03-14 | 2021-08-03 | Vdyne, Inc. | Proximal, distal, and anterior anchoring tabs for side-delivered transcatheter mitral valve prosthesis |
US11109969B2 (en) | 2018-10-22 | 2021-09-07 | Vdyne, Inc. | Guidewire delivery of transcatheter heart valve |
US11166814B2 (en) | 2019-08-20 | 2021-11-09 | Vdyne, Inc. | Delivery and retrieval devices and methods for side-deliverable transcatheter prosthetic valves |
US11173027B2 (en) | 2019-03-14 | 2021-11-16 | Vdyne, Inc. | Side-deliverable transcatheter prosthetic valves and methods for delivering and anchoring the same |
US11185409B2 (en) | 2019-01-26 | 2021-11-30 | Vdyne, Inc. | Collapsible inner flow control component for side-delivered transcatheter heart valve prosthesis |
US11202706B2 (en) | 2019-05-04 | 2021-12-21 | Vdyne, Inc. | Cinch device and method for deployment of a side-delivered prosthetic heart valve in a native annulus |
US11234813B2 (en) | 2020-01-17 | 2022-02-01 | Vdyne, Inc. | Ventricular stability elements for side-deliverable prosthetic heart valves and methods of delivery |
US11253359B2 (en) | 2018-12-20 | 2022-02-22 | Vdyne, Inc. | Proximal tab for side-delivered transcatheter heart valves and methods of delivery |
US11273033B2 (en) | 2018-09-20 | 2022-03-15 | Vdyne, Inc. | Side-delivered transcatheter heart valve replacement |
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EP3590470B1 (en) | 2023-11-15 |
BR112012030673A2 (pt) | 2016-09-13 |
US20240058125A1 (en) | 2024-02-22 |
US20210275302A1 (en) | 2021-09-09 |
EP2575682A1 (en) | 2013-04-10 |
AU2011261512B2 (en) | 2014-11-27 |
US9561102B2 (en) | 2017-02-07 |
WO2011153210A1 (en) | 2011-12-08 |
BR112012030673A8 (pt) | 2019-09-17 |
JP5774688B2 (ja) | 2015-09-09 |
US11020223B2 (en) | 2021-06-01 |
EP2575682B1 (en) | 2019-07-31 |
CN102917669A (zh) | 2013-02-06 |
EP3590470A1 (en) | 2020-01-08 |
US20110301702A1 (en) | 2011-12-08 |
AU2011261512A1 (en) | 2012-12-20 |
US11833045B2 (en) | 2023-12-05 |
US20170100246A1 (en) | 2017-04-13 |
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