JP2018533446A - 心臓弁輪を再成形するインプラント可能な機器および送達システム - Google Patents
心臓弁輪を再成形するインプラント可能な機器および送達システム Download PDFInfo
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- 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
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- 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
- 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
- A61F2/2427—Devices for manipulating or deploying heart valves during implantation
- A61F2/2439—Expansion controlled by filaments
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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
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
- A61B17/064—Surgical staples, i.e. penetrating the tissue
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
- A61B17/064—Surgical staples, i.e. penetrating the tissue
- A61B2017/0647—Surgical staples, i.e. penetrating the tissue having one single leg, e.g. tacks
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
- A61B17/064—Surgical staples, i.e. penetrating the tissue
- A61B2017/0649—Coils or spirals
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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
- A61F2220/00—Fixations or connections for prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof
- A61F2220/0008—Fixation appliances for connecting prostheses to the body
- A61F2220/0016—Fixation appliances for connecting prostheses to the body with sharp anchoring protrusions, e.g. barbs, pins, spikes
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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
- 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
- A61F2250/001—Special features of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof adjustable for adjusting a diameter
Abstract
Description
本願は、2015年11月17日出願の「僧帽弁」という発明の名称である米国仮出願第62/256,660号に基づく優先権を主張し、該出願の全体が言及によってあらゆる目的のために本願明細書に組み込まれ、本明細書の一部をなす。
一般に、インプラント可能な医療機器に関する特徴が記載される。例として、様々な機器をインプラントするための心臓弁医療機器と送達および位置決めシステムとが記載される。
心臓弁の不全は重大な問題である。例えば、心臓病は心室を膨張させ弱体化し得るものである。特に僧帽弁に関して、老化または疾患の結果として、左心室が拡張して乳頭筋が移動する。したがって、僧帽心臓弁輪が過度に拡張する。この拡張状態では、弁尖は、収縮時に適切に閉じるかまたは接触することができない。ゆえに、心室収縮時に血液の逆流(すなわち、閉じるべき弁における逆行する流れ)が起こる。したがって、心拍出量が減少する。
Claims (25)
- 心臓弁逆流を減少させるためのインプラントであって、
上部クラウン、下部クラウン、および前記上部クラウンと前記下部クラウンとの間のストラットを備えるとともに、組織係合径を有する組織係合形態と、フレームが前記組織係合径よりも小さい輪のリモデリング径を有する輪のリモデリング形態とを有するフレームと、
心臓弁輪に近接した心臓組織と係合するため、前記フレームの前記下部クラウンと連結された複数のアンカー部材と、
前記フレームの前記上部クラウンに連結された複数のカラーとを含み、
前記カラーに力が加えられると、前記カラーが前記上部クラウンおよび前記ストラットに沿ってスライドして、前記フレームを前記組織係合形態から前記輪のリモデリング形態に動かす、インプラント。 - 前記複数のアンカー部材は螺旋巻きアンカー部材であり、前記フレームの前記下部クラウンが前記螺旋巻きアンカー部材を螺合して受け入れるように構成される、請求項1に記載のインプラント。
- 前記螺旋巻きアンカー部材は、前記螺旋巻きアンカー部材を前記心臓組織に回動して前進させて前記フレームを前記心臓組織に固定するために、アクチューエータと係合するアンカー頭部をさらに含む、請求項2に記載のインプラント。
- 前記ストラットおよび前記下部クラウンと係合して前記螺旋巻きアンカー部材の移動を制限するために、前記アンカー頭部のそれぞれに支台部をさらに含む、請求項3に記載のインプラント。
- 前記螺旋巻きアンカー部材は、前記螺旋巻きアンカー部材を前記心臓組織に貫通しやすくする尖鋭先端を有する、請求項2〜4のいずれかに記載のインプラント。
- 前記カラーのそれぞれに少なくとも1つのタブをさらに含み、前記タブは、前記カラーを前記上部クラウンおよび前記ストラットにスライドさせたときに前記上部クラウンに係合するために、内方に傾けられている、請求項1〜4のいずれかに記載のインプラント。
- 前記上部クラウンの外方面側に形成された溝と、前記カラーのそれぞれに少なくとも1つのタブとをさらに含み、前記タブは前記溝に係合するために内方に傾けられている、請求項1〜4のいずれかに記載のインプラント。
- 前記カラーのそれぞれは複数の前記タブを含み、前記複数のタブは、前記フレームの前記輪のリモデリング径を選択的に変更するために、前記上部クラウンおよび前記ストラット上で前進させることができる、請求項6に記載のインプラント。
- 前記複数のタブは、前記カラーの外方に面する部分に垂直に配置されるとともに、最下部タブを含み、前記最下部タブは最初に前記上部クラウンの下側に配置および係合されている、請求項8に記載のインプラント。
- 前記カラーを前記上部クラウンおよび前記ストラットに押し込んで前進させて前記フレームを縮径させるために、前記複数のカラーと係合する複数の押込部材をさらに含む、請求項1〜4のいずれかに記載のインプラント。
- 前記カラーが前記上部クラウンおよび前記ストラット上を前進しやすくするために、前記カラーに可撓部分をさらに含む、請求項1〜4のいずれかに記載のインプラント。
- 前記フレームは長手方向軸を定め、前記下部クラウンおよび前記下部クラウンに受け入れられた前記アンカー部材は、前記インプラントの下方に遠位に延びる前記軸の一部に対して約30度〜約60度の角度で遠位方向に外方に傾斜する、請求項1〜4のいずれかに記載のインプラント。
- 心臓弁逆流を減少させるためのインプラントを送達するための送達システムであって、
上部クラウン、下部クラウン、および前記上部クラウンと前記下部クラウンとの間のストラットを備えるとともに、組織係合径を有する組織係合形態と、フレームが前記組織係合径よりも小さい輪のリモデリング径を有する輪のリモデリング形態とを有するフレーム、
心臓弁輪に近接した心臓組織と係合するため、前記フレームの前記下部クラウンと連結された複数のアンカー部材、および
前記フレームの前記上部クラウンに連結された複数のカラーを含み、
前記カラーに力が加えられると、前記カラーが前記上部クラウンおよび前記ストラット上をスライドして、前記フレームを前記組織係合形態から前記輪のリモデリング形態に動かす、前記インプラントと、
前記インプラントに着脱可能に取り付けられ、前記インプラントを前記心臓弁輪に近接した位置に送達するように構成される送達カテーテルと、
前記心臓弁輪に近接して延びるとともに、前記心臓弁輪において前記インプラントの前記心臓弁輪に対する位置の1つ以上の画像を撮像するように構成された遠位端部を含む撮像カテーテルと、を含む送達システム。 - 前記アンカー部材を前記心臓組織に貫通および前進させて前記フレームを前記心臓弁輪に近接した位置に固定するために、前記インプラントの対応する前記アンカー部材と係合する複数のアクチュエータ部材をさらに含む、請求項13に記載の送達システム。
- 前記カラーのそれぞれを対応する前記上部クラウンおよび前記ストラットに押し込んで前進させて前記フレームおよび前記弁輪の直径を減縮させるために、前記インプラントの対応する前記カラーと係合する複数の押込部材をさらに含む、請求項13に記載の送達システム。
- 前記撮像カテーテルを前記インプラントに対して中心に配置するための手段をさらに含む、請求項13〜15のいずれかに記載の送達システム。
- 前記撮像カテーテルの前記遠位端部には、長手方向に配置された超音波変換器および周方向に配置された超音波変換器を含む、請求項13〜15のいずれかに記載の送達システム。
- 前記フレームは長手方向軸を定め、前記下部クラウンおよび前記下部クラウンに受け入れられた前記アンカー部材は、前記インプラントの下方に遠位に延びる前記軸の一部に対して約45度の角度で遠位方向に外方に傾斜する、請求項13〜15のいずれかに記載の送達システム。
- 前記フレームの前記下部クラウンに近接して前記フレームを取り囲むループと、
前記ループを圧縮して、前記インプラントを前記送達システムに折り畳んで装填しやすくする圧縮アクチュエータとをさらに含む、請求項18に記載の送達システム。 - 前記カラーのそれぞれには、前記押込部材によって前記カラーを前記上部クラウンおよび前記ストラット上でスライドさせたときに、対応する前記上部クラウンの下側に係合するように内方に傾けられている、複数のタブを含み、
前記フレームが前記心臓組織に固定された後、前記ループは圧縮されるととももに前記フレームの直径の所望の減縮を決定して、前記カラーおよび前記タブを対応する前記上部クラウンおよび前記ストラット上で前進させる、請求項19に記載の送達システム。 - 拡大した心臓弁輪のサイズを縮小させる方法であって、
近位端および遠位端を有する、送達システム内のインプラントを、前記拡大した心臓弁輪の上方で近接した部位に送達するステップと、
前記インプラントを前記送達システムから放出して、前記インプラントを組織係合径にするステップと、
前記インプラントの前記遠位端を、前記拡大した心臓弁輪の上方で近接した心臓組織に固定するステップと、
複数のカラーを前記インプラントの前記近位端の対応する上部クラウン上で移動させて、前記組織係合径を輪のリモデリング径に減縮させることで、前記拡大した心臓弁輪の前記サイズを縮小させるステップと、
固定されかつ縮径した前記インプラントを前記送達システムから外すステップとを含む、方法。 - 複数の置換弁尖を有する置換弁と、
前記置換弁尖に固定された管状弁筐体と、
前記管状弁筐体に連結されて前記管状弁筐体を周方向に取り囲むとともに、上部クラウン、下部クラウン、および前記上部クラウンと前記下部クラウンとの間のストラットを有し、対向する上部クラウンが組織係合径によって隔てられる組織係合形態と、対向する上部クラウンが前記組織係合径よりも小さい輪のリモデリング径によって隔てられる輪のリモデリング形態との間で構成可能である、締上フレームと、
心臓弁輪に近接した心臓組織に係合するため、前記締上フレームの前記上部クラウンに連結された複数のアンカー部材と、
前記締上フレームの前記下部クラウンに連結された複数のカラーとを含み、
前記カラーに力が加えられると、前記カラーは前記下部クラウンおよび前記ストラット上をスライドして、前記締上フレームを前記組織係合形態から前記輪のリモデリング形態に向かって再形成する、心臓弁置換インプラント。 - 前記心臓弁置換システムがインプラントされるときに心臓弁の心房側に配置される前記締上フレームのシーリングフランジをさらに含む、請求項22に記載の心臓弁置換インプラント。
- 複数の置換弁尖を有する置換弁と、
前記置換弁尖に固定された管状弁筐体と、
前記管状弁筐体に連結されて前記管状弁筐体を周方向に取り囲むとともに、上部クラウン、下部クラウン、および前記上部クラウンと前記下部クラウンとの間のストラットを有し、対向する下部クラウンが組織係合径によって隔てられる組織係合形態と、対向する下部クラウンが前記組織係合径よりも小さい輪のリモデリング径によって隔てられる輪のリモデリング形態との間で構成可能である、締上フレームと、
心臓弁輪に近接した心臓組織に係合するため、前記締上フレームの前記下部クラウンに連結された複数のアンカー部材と、
前記締上フレームの前記上部クラウンに連結された複数のカラーとを含み、
前記カラーに力が加えられると、前記カラーは前記上部クラウンおよび前記ストラット上をスライドして、前記締上フレームを前記組織係合形態から前記輪のリモデリング形態に向かって再形成する、心臓弁置換インプラント。 - 前記管状弁筐体は近位端と遠位端とを有し、前記締上フレームの前記上部クラウンは、前記上部クラウンと前記締上フレームとが前記弁筐体の前記近位端の周りで回動するように前記弁筐体の前記近位端の開口部に受け入れられるように構成された延長部を有する、請求項24に記載の心臓弁置換システム。
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US11576778B2 (en) | 2023-02-14 |
CN108289737B (zh) | 2020-03-31 |
CN111329541A (zh) | 2020-06-26 |
EP3377000B1 (en) | 2023-02-01 |
US20190374343A1 (en) | 2019-12-12 |
JP6892446B2 (ja) | 2021-06-23 |
WO2017087424A1 (en) | 2017-05-26 |
JP2021121364A (ja) | 2021-08-26 |
IL259333A (en) | 2018-07-31 |
EP3377000A1 (en) | 2018-09-26 |
US20170135816A1 (en) | 2017-05-18 |
US10555813B2 (en) | 2020-02-11 |
CN111329541B (zh) | 2023-09-19 |
US20230157823A1 (en) | 2023-05-25 |
CN108289737A (zh) | 2018-07-17 |
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