JP2016521633A - 僧帽弁スペーサ並びにその移植システム及び方法 - Google Patents
僧帽弁スペーサ並びにその移植システム及び方法 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
- A61F2/2442—Annuloplasty rings or inserts for correcting the valve shape; Implants for improving the function of a native heart valve
- A61F2/246—Devices for obstructing a leak through a native valve in a closed condition
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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
- A61F2/2442—Annuloplasty rings or inserts for correcting the valve shape; Implants for improving the function of a native heart valve
- A61F2/2466—Delivery devices 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
- A61F2250/00—Special features of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof
- A61F2250/0003—Special features of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof having an inflatable pocket filled with fluid, e.g. liquid or gas
-
- 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
- A61F2250/00—Special features of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof
- A61F2250/0004—Special features of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof adjustable
-
- 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
- A61F2250/00—Special features of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof
- A61F2250/0058—Additional features; Implant or prostheses properties not otherwise provided for
- A61F2250/0096—Markers and sensors for detecting a position or changes of a position of an implant, e.g. RF sensors, ultrasound markers
- A61F2250/0098—Markers and sensors for detecting a position or changes of a position of an implant, e.g. RF sensors, ultrasound markers radio-opaque, e.g. radio-opaque markers
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- Health & Medical Sciences (AREA)
- Cardiology (AREA)
- Engineering & Computer Science (AREA)
- Life Sciences & Earth Sciences (AREA)
- Transplantation (AREA)
- Biomedical Technology (AREA)
- Heart & Thoracic Surgery (AREA)
- Vascular Medicine (AREA)
- Oral & Maxillofacial Surgery (AREA)
- Animal Behavior & Ethology (AREA)
- General Health & Medical Sciences (AREA)
- Public Health (AREA)
- Veterinary Medicine (AREA)
- Prostheses (AREA)
- Mechanical Engineering (AREA)
- Surgical Instruments (AREA)
Abstract
Description
本出願は、2013年7月14日の米国仮特許出願61/835093号に基づく優先権を主張するものであり、引用により当該仮出願の全内容を包含するものである。
本発明は、心臓インプラントを移植するシステム及び方法に関する。例えば、本発明の一実施形態に係るシステム及び方法は、機能不全又は動作不能の心臓弁(例えば、機能性僧帽弁逆流及び変性僧帽弁逆流が生じた心臓弁)の治療、診断、及び/又は矯正に関連して適切に用いることができる、心臓弁インプラントを移植するのに用いることができる。本発明に関連する心臓弁インプラントの適切な実施例の1つとして、僧帽弁逆流(僧帽弁機能不全 )の治療がある。説明を簡便にするため、本明細書における心臓弁インプラントは、僧帽弁インプラントの観点から記載するものであり、例えば、特許文献1:米国特許第8092525号明細書(2005年10月26日の同国特許出願番号第11/258828号)、及び、特許文献2:米国特許出願公開第2009/0048668号明細書(2008年9月12日出願の同国特許出願番号第12/209686号)に記載されたような僧帽弁逆流の治療に用いることができる。両明細書は、ここに、本明細書の一部を構成するものとして内容を援用する。しかしながら、本発明に係る心臓弁インプラントは、図26に関連して本明細書で論じる心臓弁インプラントのように、他の機能不全又は動作不能の心臓弁を治療、診断、及び/又は矯正するのに使用することができる。
n=定数であり、両端が移動または回転不能にクランプされている円柱ではn=4。
E=物質の弾性率(psi)であり、
I=慣性モーメント(in4)である。
円形断面の場合、慣性モーメントは次式(数2)で表す。
拡張器34は、偏向可能な先端98及び/又は拡張部114を備えなくても僧帽弁を通して前進させることができるが、1つ以上の偏向可能な先端98及び/又は拡張部114を用いることで、心臓1を損傷させる可能性及び/又は僧帽弁61内で引っかかる可能性を低減することができると解すべきである。シャフト96の第2セグメント97bは、基本的に、経中隔穿刺部位13に近接する拡張器34の屈曲又は湾曲の位置に相当し得る。理解され得るように、経中隔穿刺部位13と左心室3との間の拡張器34の湾曲は、比較的急なものであることを要する。
Claims (27)
- 近位端及び遠位端を有するキャビティを画定する膨張弁本体と、
前記膨張弁本体の近位端を通って延在するシャフトであって、前記キャビティと流体連通した内腔を備えるシャフトと、
前記膨張弁本体に近接した前記シャフトに取り付けられたアンカーアセンブリと、
前記シャフトの内腔と流体連通した1つ以上の内腔を備える膨張ポートと、
を備える心臓弁インプラント。 - 1つ以上のX線不透過性マーカをさらに備える、請求項1に記載の心臓弁インプラント。
- 前記1つ以上のX線不透過性マーカは、前記膨張弁本体の近位端又はその近傍に位置する、請求項2に記載の心臓弁インプラント。
- 前記膨張ポートは、該膨張ポートを流体封止するように構成された、突き刺し可能なセプタムをさらに備える、請求項1に記載の心臓弁インプラント。
- 前記突き刺し可能なセプタムは、シリコーンを含む、請求項4に記載の心臓弁インプラント。
- 前記突き刺し可能なセプタムは、液密構造を備える、請求項4に記載の心臓弁インプラント。
- 前記膨張ポートは、1つ以上の縫合糸穴をさらに備える、請求項5に記載の心臓弁インプラント。
- 前記アンカーアセンブリは、通路と、1本以上のアームと、を備え、
前記通路は前記シャフトを受け入れ、前進させるように構成され、
前記1本以上のアームのそれぞれが開口部を画定し、
前記アンカーアセンブリは、患者の心臓の外面に固定されるように構成されている、請求項1に記載の心臓弁インプラント。 - 前記アンカーアセンブリの前記1本以上のアームのそれぞれの周囲に、1本以上の縫合糸が配置されている、請求項8に記載の心臓弁インプラント。
- 前記膨張弁本体は、膨張流体によって部分的に又は完全に膨張させられる、請求項1に記載の心臓弁インプラント。
- 前記シャフトは、前記膨張弁本体の遠位端に取り付けられている、請求項1に記載の心臓弁インプラント。
- 前記膨張弁本体と流体連通した内腔は、1つ以上の開口部を備える、請求項11に記載の心臓弁インプラント。
- 膨張弁本体と、シャフトと、アンカーアセンブリと、膨張ポートと、を備える心臓弁インプラントを、心臓内に経心尖的に送達する方法であって、
内腔を備える導入器を、心臓の頂端にある切開部を通して左心室へと、経心尖的に前進させるステップと、
前記導入器を、僧帽弁を通して左心房へと前進させるステップと、
前記心臓弁インプラントを、前記導入器の内腔を通して前記左心房へと前進させるステップであって、前記心臓弁インプラントの前記シャフトは、前記膨張弁本体から頂端にある切開部を越えて延在するステップと、
前記心臓から前記導入器を除去し、前記膨張弁本体及び前記シャフトの少なくとも一部を心臓内に送達するステップと、
を含む方法。 - 前記アンカーアセンブリは、通路と、1本以上のアームと、を備え、
前記通路は前記シャフトを受け入れ、前進させるように構成され、
前記1本以上のアームのそれぞれが開口部を画定する、請求項13に記載の方法。 - 前記アンカーアセンブリを、前記アンカーアセンブリが心臓の頂端又はその近傍に達するまでシャフト上で前進させるステップをさらに含む、請求項14に記載の方法。
- 前記アンカーアセンブリを、前記心臓の前記頂端又はその近傍の、前記心臓の外面に固定するステップをさらに含む、請求項15に記載の方法。
- 前記アンカーアセンブリを固定するステップは、前記アンカーアセンブリの1本以上のアームのそれぞれの周囲に1本以上の縫合糸を縫合するステップを含む、請求項16に記載の方法。
- 胸壁又はその近傍の皮下に膨張ポートを固定するステップをさらに含む、請求項13に記載の方法。
- 前記膨張弁本体は、前記僧帽弁内の前記膨張弁本体の位置を特定するための1つ以上のX線不透過性マーカを備える、請求項13に記載の方法。
- 膨張流体によって、前記膨張弁本体を、完全に又は部分的に膨張させるステップをさらに含む、請求項13に記載の方法。
- 前記膨張弁本体を膨張させるステップは、
前記膨張ポートの突き刺し可能なセプタムを突き刺すステップと、
前記突き刺し可能なセプタムを通して、前記膨張ポートに膨張流体を導入し、該膨張流体によって前記膨張弁本体を膨張させるステップと、をさらに含む請求項20に記載の方法。 - 前記膨張流体は液体である、請求項21に記載の方法。
- 前記膨張弁本体は、僧帽弁の少なくとも1つの心臓弁膜尖の全体又は一部と相互作用する、請求項21に記載の方法。
- 前記膨張弁本体は、閉口位置にある前記僧帽弁を通る血流を、部分的に又は完全に制限する、請求項21に記載の方法。
- 前記インプラントを脱気するステップをさらに含む、請求項21に記載の方法。
- 所望の水準の膨張が得られるまで、前記インプラント内の膨張流体の量を調整するステップをさらに含む、請求項20に記載の方法。
- 膨張弁本体と、シャフトと、アンカーアセンブリと、膨張ポートと、を備える心臓弁インプラントを、心臓内に経心尖的に送達する方法であって、
内腔を備える導入器を、心臓の頂端にある切開部を通して左心室へと、経心尖的に前進させるステップと、
前記心臓弁インプラントを、前記導入器の内腔を通して左心室へと前進させるステップであって、前記膨張弁本体は前記導入器から延在するステップと、
前記膨張弁本体を部分的に膨張させるステップと、
前記導入器及び部分的に膨張した前記膨張弁本体を、僧帽弁を通して左心房へと前進させるステップと、
前記心臓弁インプラントを、前記導入器の内腔を通して前記左心房へと前進させるステップと、
前記導入器を前記心臓から除去し、前記膨張弁本体及び前記シャフトの少なくとも一部を前記心臓内に送達するステップと、
を含む方法。
Applications Claiming Priority (3)
Application Number | Priority Date | Filing Date | Title |
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US201361835093P | 2013-06-14 | 2013-06-14 | |
US61/835,093 | 2013-06-14 | ||
PCT/US2014/042465 WO2014201452A1 (en) | 2013-06-14 | 2014-06-16 | Mitral valve spacer and system and method for implanting the same |
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JP2016521633A true JP2016521633A (ja) | 2016-07-25 |
JP6731339B2 JP6731339B2 (ja) | 2020-07-29 |
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US (2) | US9980812B2 (ja) |
EP (1) | EP3007651B1 (ja) |
JP (1) | JP6731339B2 (ja) |
KR (1) | KR20160041040A (ja) |
CN (1) | CN105473107B (ja) |
AU (2) | AU2014277902A1 (ja) |
CA (1) | CA2915073A1 (ja) |
WO (1) | WO2014201452A1 (ja) |
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US10682231B2 (en) | 2014-09-29 | 2020-06-16 | The Provost, Fellows Foundation Scholars, and The Other Members of the Board, of the College of The Holy and Undivided Trinity of Queen Elizabeth Near Dublin (TCD) | Heart valve treatment device and method |
US10987220B2 (en) | 2014-09-29 | 2021-04-27 | The Provost, Fellows Foundation Scholars, and The Other Members of the Board, of the College of The Holy and Undivided Trinity of Queen Elizabeth Near Dublin (TCD) | Heart valve treatment device and method |
US10952854B2 (en) | 2018-02-09 | 2021-03-23 | The Provost, Fellows, Foundation Scholars And The Other Members Of Board, Of The College Of The Holy And Undivided Trinity Of Queen Elizabeth, Near Dublin (Tcd) | Heart valve therapeutic device |
US11207182B2 (en) | 2018-02-09 | 2021-12-28 | The Provost Fellows, Foundation Scholars and the Other Members of Board, of the College of the Holy and Undivided Trinity of Queen Elizabeth, Near Dublin (TCD) | Heart valve therapeutic device |
US12036121B2 (en) | 2018-02-09 | 2024-07-16 | The Provost, Fellows, Foundation Scholars, And The Other Members Of Board, Of The College Of The Holy And Undivided Trinity Of Queen Elizabeth Near Dublin (TCD) | Heart valve therapeutic device |
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Also Published As
Publication number | Publication date |
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CA2915073A1 (en) | 2014-12-18 |
CN105473107A (zh) | 2016-04-06 |
JP6731339B2 (ja) | 2020-07-29 |
EP3007651B1 (en) | 2020-08-05 |
US9545305B2 (en) | 2017-01-17 |
CN105473107B (zh) | 2018-05-11 |
US20140371846A1 (en) | 2014-12-18 |
US9980812B2 (en) | 2018-05-29 |
AU2019201773A1 (en) | 2019-04-04 |
US20140371843A1 (en) | 2014-12-18 |
WO2014201452A1 (en) | 2014-12-18 |
AU2014277902A1 (en) | 2016-02-04 |
EP3007651A1 (en) | 2016-04-20 |
KR20160041040A (ko) | 2016-04-15 |
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