JP2019048166A - 人工弁のための一体型縫合カフを有するフレーム - Google Patents
人工弁のための一体型縫合カフを有するフレーム Download PDFInfo
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- JP2019048166A JP2019048166A JP2018223601A JP2018223601A JP2019048166A JP 2019048166 A JP2019048166 A JP 2019048166A JP 2018223601 A JP2018223601 A JP 2018223601A JP 2018223601 A JP2018223601 A JP 2018223601A JP 2019048166 A JP2019048166 A JP 2019048166A
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- Prior art keywords
- frame
- fabric
- prosthetic valve
- composite material
- film layer
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Classifications
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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
- A61F2/2412—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
- A61F2/2415—Manufacturing methods
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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
- A61F2/2409—Support rings therefor, e.g. for connecting valves to tissue
-
- 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
- A61F2210/00—Particular material properties of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof
- A61F2210/0076—Particular material properties of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof multilayered, e.g. laminated structures
-
- 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
- A61F2250/0069—Sealing means
- A61F2250/007—O-rings
Abstract
Description
人工弁との関連において本明細書で使用する用語「弁葉」は、圧力差の影響を受けて開放位置と閉鎖位置との間を移動するように動作可能な一方向弁の構成要素である。開放位置では、この弁葉は血液が人工弁を通って流れることを可能にする。閉鎖位置では、人工弁内の逆流を阻止する。複数枚の弁葉を含む実施態様では、各弁葉は、少なくとも1つの隣接する弁葉と協働して、血液の逆流を阻止する。血液中の圧力差は、例えば、心臓の心室又は心房の収縮によって引き起こされ、そのような圧力差は、典型的には、閉鎖位置にある弁葉の片側に形成される流体圧から生じる。人工弁の流入側の圧力が人工弁の流出側の圧力より高くなると、弁葉が開き、血液がそこを通って流れる。血液が人工弁を通って隣接する室又は血管に流入するにつれ、流入側圧力は流出側圧力と均衡する。人工弁の流出側の圧力が人工弁の流入側の血圧よりも高くなると、弁葉は閉鎖位置に戻り、人工弁を通る血液の逆流を防止する。弁葉は、ウシ心膜等の生物学的組織、又は生体適合性ポリマー等の十分に柔軟で可撓性のある合成生体適合性材料から構成されてもよい。
当業者であれば、本開示の様々な側面が、意図された機能を実行するように構成された任意の数の方法及び装置によって実現されることを容易に理解できよう。換言すれば、意図された機能を実行するために、他の方法及び装置を本明細書に組み込むことができる。本明細書で参照される添付図面は、必ずしも一定の縮尺で描かれているわけではなく、本開示の様々な側面を説明するために誇張されていてもよく、その点に関して、図面は限定的であると解釈されるべきではないことに留意されたい。
図1Aは、一実施態様による人工弁100の側面図である。図1Bは、図1Aの人工弁100の斜視図であり、図1Cは、C−Cで切った線に沿った図1Aの人工弁100の一部の軸方向断面図である。人工弁100は、複数枚の弁葉122と、縫合カフ116を有するフレーム組立体120とを含む。縫合カフ116を有するフレーム組立体120は、フレーム内面124及びフレーム外面126を有するフレーム110と、孔を有する布帛であってフレーム110に結合されており、フレーム110を超えて延在することで縫合カフ116を形成する布帛フレーム部分114を規定する布帛112と、布帛112が複合材料118とフレーム110との間にあるように布帛フレーム部分114の少なくとも一部に結合した複合材料118とを含む。
図1A〜1Cに示すように、フレーム110は、所定の繰り返しパターンを規定する管状部材である。フレーム110は、フレーム第1端部136と、フレーム第1端部136に対向するフレーム第2端部138とを備える。フレーム第1端部136には、フレーム基部140が配置されている。フレーム第1端部136からフレーム第2端部138までに、複数のフレーム支柱要素142が互いに間隔をあけて所定の反復パターンで延びている。フレーム110は、図1Cに示すように、フレーム外面126及びフレーム外面126に対向するフレーム内面124をさらに備える。
弁葉窓144はそれぞれ、2つの弁葉窓側部146と、弁葉窓基部148とを含む。以下でより詳細に説明するように、生体適合性材料が弁葉窓144の各々の上に配置され、弁葉122を形成する。弁葉窓144は、人工弁100の実施態様の特定の目的に適した任意の形状を規定することができ、放物線形状、台形状、及び三角形状を含むがこれらに限定されない。
外科的移植に適した人工弁100の実施態様によれば、人工弁100は、一実施態様によるフレーム外面126の周りに、図1A〜図1C及び図4に示すように縫合カフ116をさらに備える。縫合カフ116は、人工弁100を組織口等の移植部位に結合するための縫合糸を受け取る構造を提供するように動作可能である。縫合カフ116は、フレーム110のフレーム基部140の周りに円周状に、即ち、放物線状に配置、換言すれば、フレーム基部140から軸方向に延在させてもよい。
図1B、図2A及び図2Bに示されるように、各弁葉窓144には、弁葉窓側部146及び弁葉窓基部148に結合されたフィルム又はウシ心膜等の弁葉122を規定する生体適合性材料が設けられている。弁葉122の形状は、弁葉窓144と弁葉自由端154との形状によって部分的に規定される。
フィルム150は、実施態様に従って、生物学的に適合し、フレーム110に結合するように構成された任意のシート状材料である。当然ながら、用語「フィルム」は、特定の目的に適した1つ以上の生体適合性材料に対して一般的に使用される。
人工弁100は、生物活性剤をさらに含むことができる。生物活性剤は、人工弁100が移植された後に生物活性剤の放出を制御するためにフィルム150の一部又は全体に塗布することができる。生物活性剤は、血管拡張剤、抗凝固剤、抗血小板剤、抗血栓剤(限定されないが、ヘパリン等)含むがこれらに限定されない。他の生物活性材としては、ビンカアルカロイド(即ちビンブラスチン、ビンクリスチン及びビノレルビン)、パクリタクセル、エピジポドフィロトキシン(即ち、エトポシド、テニポシド)、抗生剤(ダクチノマイシン(アクチノマイシンD)ダウノルビシン、ドキソルビシン及びイダルビシン)、アントラサイクリン、ミトキサントロン、ブレオマイシン、プリカマイシン(ミトラマイシン)及びミトミシン、酵素(Lアスパラギンを全身的に代謝させかつ自身のアスパラギンを合成する能力を持たない細胞を奪うLアスパラギナーゼ)等の天然物を含む抗増殖/抗有糸分裂剤、G(GP)IIb/IIIa阻害剤及びビトロネクチン受容体拮抗剤等の抗血小板剤、窒素マスタード(メクロルエタミン、シクロフォスファミド及び類似体、メルファラン、クロラムブシル)、エチレンイミン及びメチルメラミン(ヘクサメチルメラニン及びチオテパ)、アルキルスルフォン酸ブスルファン、ニトロソ尿素(カルムスチン(BCNU)及び類似体、ストレプトゾシン)、トラゼンスダカルバジン(DTIC)などの抗増殖/抗有糸分裂アルキル化剤、葉酸類似体(メトトレキサート)、ピリミジン類似体(フッ素化ウラシル、フロクシウリジン及びシタラビン)、プリン類似体及び関連抑制剤(メルカプトプリン、チオグアニン、ペントスタチン及び2−クロロデオキシアデノシン(クラドリビン))などの抗増殖/抗有糸分裂代謝拮抗剤、プラチナ配位化合物(シスプラチン、カルボプラチン)、プロカルバジン、ヒドロキシ尿素、ミトタン、アミノグルテチミド、ホルモン(即ち、エストロゲン)、抗凝固剤(ヘパリン、合成ヘパリン塩及びその他のトロンビン抑止剤)、繊維素溶解剤(組織プラスミノーゲン活性化剤、ストレプトキナーゼ及びウロキナーゼなど)、アスピリン、ジピリダモール、チクロピジン、クロピドグレル、アブシキシマブ、移行抑制剤、分泌抑制剤(ベレベルジン)、副腎皮質ステロイド(コルチゾール、コルチゾン、フルドロコルチゾン、プレドニゾン、プレドニソロン、6α−メチルプレドニソロン、トリアムンシノロン、ベータメタゾン及びデキサメタゾン)、非ステロイド剤(サルチル酸誘導体即ちアスピリン、パラアモノフェノール誘導体即ちアセトミノフェン、インドール及びインデン酢酸(インドメタシン、スリンダク及びエトダラック)、ヘテロアリル酢酸(トルメチン、ジクロフェナック及びケトロラック)、アリルプロピオン酸(イブプロフェン及び誘導体)、アントラニル酸(メフェナム酸及びメクロフェナム酸)、エノール酸(ピロキシカム、テノキシカム、フェニールブタゾン及びオキシフェンタトラゾン)、ナブメタン、金化合物(アウラノフィン、アウロチオグルコース、チオリンゴ酸金ナトリウム)等の抗炎症剤、免疫抑制剤(シクロスポリン、タクロリムス(FK−506)、シロリムス(ラパミシン)、アゾチオプリン、ミコフェノール酸モフェチル)、血管形成剤、血管内皮成長因子(VEGF)、繊維芽細胞成長因子(FGF)、アンジオテンシン受容体遮断剤、一酸化窒素供与体、アンチセンスオリジオヌクレオチド及びその化合物、細胞周期抑制剤、mTOR抑制剤及び成長因子受容体シグナル伝達キナーゼ抑制剤、レチノイド、サイクリン/CDK抑制剤、HMGコエンザイムレダクターゼ抑制剤(スタチン)及びプロテアーゼ抑制剤、が挙げられるが、これらに限定されない。
本明細書に記載の実施態様はまた、本明細書に記載の人工弁の実施態様を製造する方法に関する。様々な実施態様を製造するために、円筒形組立体168を使用することができる。図5、図6A〜図6Cを参照すると、組立体マンドレル168は、フレーム110をその上に受容するように動作可能な構造形態を含む。人工弁100を製造する方法の実施態様は、図1Aの縫合カフ116を形成するのに使用されるフレーム基部140を越えて延びる布帛112の布帛中央部分160で布帛112をフレーム110に結合する工程と;布帛フレーム部分114にエラストマーを吸収させ、エラストマーが布帛112の布帛細孔内に存在するようにしながら、縫合カフ116に形成される布帛112の布帛中央部分160を布帛112の布帛細孔内にエストマーを含まない状態に維持する工程と;センブリを熱的に硬化させる工程と;布帛フレーム部分114がフレーム110と複合材料118との間に位置するように複合材料118を布帛フレーム部分114に結合する工程を含む。
当然であるが、特定の方法及び装置が以下に記載するが、当業者によって適切であると判断する任意の方法又は装置を代わりに利用できる。
膜サンプルを型抜きして、約2.54cm×約15.24cmの長方形切片を形成し、重量(Mettler-Toledo分析用天秤AG204型を使用)及び厚さ(KaferFz1000/30はさみゲージを使用)を測定した。これらのデータを用いて、下記の式を用いて密度を計算した:ρ=m/(w*l*t)(式中、ρ=密度(g/cm3)、m=質量(g)、w=幅(cm)、l=長さ(cm)、及びt=厚さ(cm)。3回の測定の平均を記録した。
引っ張り破断荷重は、平面グリップと0.445kNのロードセルを備えるINSTRON 122引張試験機を用いて測定した。ゲージ長は約5.08cmであり、クロスヘッド速度は約50.8cm/分であった。試料の寸法は、約2.54cm×約15.24cmであった。最高強度測定のために、試料の寸法の長い方を最も高い強度方向に向けた。直交MTS測定の場合は、試料の寸法の長い方を最高強度方向に対して垂直に向けた。Mettler Toledo天秤AG204型を用いて各試料の重量を測定し、次にKaferFZ1000/30はさみゲージを用いて厚さを測定したが、代わりに、厚さの測定には任意の適切な手段を使用することもできる。次いで、試料を引張り試験機で個々に試験した。各試料の3つの異なる断面を測定した。縦方向及び横方向のマトリックス引張強さ(MTS)は、以下の式を使用して計算した:MTS=(最大荷重/断面積)*(PTFEの嵩密度)/(多孔質膜の密度)(式中、PTFEの嵩密度は、約2.2g/cm3とした)。試験片の空隙率は、引張強さに、試験片の密度に対するポリマーの密度の比を掛けることによって説明される。
ASTM F31 6−03の一般的教示に従って、毛管流細孔測定装置(Porous Materials社、米国、ニューヨーク、イサカ)のモデルCFP 1500AEXLを使用して、気泡点及び平均流細孔径を測定した。試料膜を試料室に入れ、約20.1ダイン/cmの表面張力を有するSilWick Silicone Fluid(Porous Materials社から入手可能)で湿らせた。試料室の底部クランプは、直径約2.54cmの穴を有していた。Capwinソフトウェアバージョン7.73.012を使用して、以下のパラメータを次の表に示すように設定した。
Claims (27)
- 管状の形状を規定するフレームと、布帛細孔を有する布帛と、複合材料とを含み、前記布帛は布帛フレーム部分と前記布帛フレーム部分に対向する縫合カフとを規定し、前記縫合カフと前記布帛フレーム部分とは一体型に形成され、前記布帛フレーム部分は前記布帛細孔内に存在するエラストマーを有し、前記布帛フレーム部分は前記フレームに結合されており、前記複合材料は前記フレームと前記複合材料との間に位置する前記布帛フレーム部分の少なくとも一部分に結合し、ここで前記縫合カフは前記フレームから延びて設けられることにより、前記縫合カフが組織内殖を促進すると共に、前記布帛フレーム部分周囲の他の部位では組織内殖が抑制される、人工弁フレーム組立体。
- 前記フレームはフレーム内面と前記フレーム内面とは反対側のフレーム外面とを有すると共に、(a)前記布帛フレーム部分は前記フレーム内面に結合し、前記布帛フレーム部分は前記フレーム内面と前記複合材料との間に位置するか、又は、(b)前記フレーム部は前記フレーム外面に結合し、前記布帛フレーム部分は前記フレーム外面と前記複合材料との間に位置するか、又は、(c)前記フレーム部は前記フレーム内面及び前記フレーム外面に結合し、前記布帛フレーム部分は前記フレーム内面と前記複合材料との間に位置し、前記布帛フレーム部分は前記フレーム外面と前記複合材料との間に位置する、請求項1に記載の人工弁フレーム組立体。
- 前記フレームはフレーム内面と、前記フレーム内面とは反対側のフレーム外面とを有し、前記布帛は布帛第1端部と、前記布帛第1端部に対向する布帛第2端部と、前記布帛第1端部と前記布帛第2端部との間の布帛中央部とを規定し、前記布帛フレーム部分は前記布帛第1端部と前記布帛第2端部を含み、前記縫合カフは布帛中央部分での折畳み部で確定され、前記布帛第1端部は前記フレーム内面と結合し、前記布帛第2端部は前記フレーム外面と結合し、前記複合材料は内側複合材料を含み、前記内側複合材料は前記フレーム内面と前記内側複合材料との間に位置する前記布帛第1端部に結合し、前記複合材料は外側複合材料を含み、前記外側複合材料は前記フレーム外面と前記外側複合材料の間に位置する前記布帛第2端部に結合している、請求項1に記載の人工弁フレーム組立体。
- 前記縫合カフを嵩高にする前記布帛中央部分の前記折畳み部に充填材量をさらに含む、請求項3に記載の人工弁フレーム組立体。
- 前記縫合カフは前記布帛細孔内に存在するエラストマーを有しない、請求項1に記載の人工弁フレーム組立体。
- 前記縫合カフの所定の部分は前記布帛細孔内に存在するエラストマーを有する、請求項1に記載の人工弁フレーム組立体。
- 前記フレームはフレーム基部を規定し、前記縫合カフは前記フレーム基部から延びている、請求項1に記載の人工弁フレーム組立体。
- 前記フレームは、前記フレーム基部から延び前記フレーム基部に隣接する複数の弁葉窓を規定する2つ以上のフレーム支柱要素をさらに含む、請求項7に記載の人工弁フレーム組立体。
- 前記複合材料は前記布帛フレーム部分からその中の弁葉を規定する前記弁葉窓の各々の中に延びている、請求項8に記載の人工弁フレーム組立体。
- (a)前記布帛フレーム部分は前記フレーム基部から前記フレーム支柱要素の少なくとも一部まで延びているか、または、(b)前記布帛フレーム部分は前記フレーム基部から実質に全ての前記フレーム支柱要素まで延びているか、または、(c)前記布帛フレーム部分は前記フレーム基部から、少なくとも部分的に前記弁葉窓内に延びる前記弁葉窓を規定する前記フレーム支柱要素を越えて延びているか、または、(d)前記布帛フレーム部分は前記フレーム基部で前記フレームに結合している、請求項8に記載の人工弁フレーム組立体。
- 前記複数の弁葉窓の各々において前記フレームに結合された弁葉をさらに含む、請求項8に記載の人工弁フレーム組立体。
- 前記複合材料は多孔質構造を有する膜と前記多孔質構造内に存在するエラストマーとを含む、請求項8に記載の人工弁フレーム組立体。
- 前記縫合カフは前記布帛の2つ以上の層からなる、請求項1に記載の人工弁フレーム組立体。
- 前記縫合カフは前記布帛の前記2つ以上の層の間に充填材料をさらに含む、請求項13に記載の人工弁フレーム組立体。
- 前記複合材料はフッ素化ポリマー膜細孔を有する少なくとも1つのフッ素化ポリマー層と前記フッ素化ポリマー膜細孔内に存在するエラストマーとを含む、請求項1に記載の人工弁フレーム組立体。
- 前記布帛はポリエチレンテレフタレート及び/又はPTFEを含む、請求項1に記載の人工弁フレーム組立体。
- 前記布帛は単一の布帛片で構成されている、請求項1に記載の人工弁フレーム組立体。
- 前記布帛は互いに結合された2つ以上の布帛片で構成されている、請求項1に記載の人工弁フレーム組立体。
- 前記2つ以上の布帛片は、一緒に縫い合わされて結合しているか、又は接着剤によって結合している、請求項18に記載の人工弁フレーム組立体。
- 前記フレームに結合された複数の弁葉をさらに含む、請求項1に記載の人工弁フレーム組立体。
- 人工弁用フレーム組立体の製造方法であって、第1のフィルム層をマンドレルの周りの管状形態に巻き付ける工程と、管状の形状を有する布帛を準備する工程と、前記第1のフィルム層の上に部分的に前記布帛を配置する工程と、フレーム内面及びフレーム外面を有し、フレーム基部および複数の弁葉窓を規定する、管状の形状を有するフレームを準備する工程と、前記第1のフィルム層の上にある前記布帛の上に、フレーム内面を前記布帛と接触させて前記フレームを配置する工程と、前記布帛を前記フレーム基部上及び前記フレーム外面上で裏返して前記フレーム外面に接触させる(前記フレーム基部から延びる布帛の折畳み部を規定し、その折畳み部で縫合カフを規定する)工程と、前記フレーム外面上にある前記布帛上に第2のフィルム層を巻きつける工程と、前記第1のフィルム層と前記第2のフィルム層とを互いに布帛及びフレームに結合させる工程と、を含む、方法。
- 人工弁フレーム組立体の製造方法であって、第1のフィルム層をマンドレルの周りに管状に巻き付ける工程と、前記第1のフィルム層の上に部分的に管状の形状を有する布帛を準備する工程と、第2のフィルム層を巻き付け、前記第1のフィルム層の上に部分的にある布帛の一部とする工程と、フレーム内面及びフレーム外面を有し、フレーム基部及び複数の弁葉窓を規定する、管状の形状を有するフレームを準備する工程と、前記第1のフィルム層の上にある前記布帛の上にある前記第2のフィルム層の上に、フレーム内面を前記第2のフィルム層と接触させて前記フレームを配置する工程と、第3のフィルム層を巻き付け、前記フレーム外面とする工程と、前記布帛を前記フレーム基部上及び前記フレーム外面上で裏返し前記フレーム外面を覆う前記第3のフィルム層に接触させる(前記フレーム基部から延びる前記布帛の折畳み部を規定し、その折畳み部で縫合カフを規定する)工程と、前記フレーム外面上にある前記布帛上に第4のフィルム層を巻きつける工程と、前記第1のフィルム層、前記フレームと前記第2及び第3のフィルム層との間の前記布帛、第2、第3及び第4のフィルム層を互いに結合させ、さらに前記フレームに結合させる工程と、を含む、方法。
- 前記布帛の前記折畳み部に充填材を供給することをさらに含み、前記布帛を裏返した後に前記充填材を前記折畳み部内に収容する、請求項21又は22に記載の人工弁用フレーム組立体の製造方法。
- 1つ以上の弁葉を前記フレームに結合することをさらに含む、請求項21又は22に記載の人工弁用フレーム組立体を製造する方法。
- 前記フレームは、前記フレーム基部に隣接する前記複数の弁葉窓を規定する前記フレーム基部から延びる2つ以上のフレーム支柱要素をさらに含む、請求項21又は22に記載の人工弁用フレーム組立体の製造方法。
- 前記第1のフィルム層及び前記第2のフィルム層のうちの1つ以上が、その中の弁葉を規定する前記弁葉窓のそれぞれの中に延びている、請求項21に記載の人工弁用フレーム組立体の製造方法。
- 前記第1のフィルム層、前記第2のフィルム層、前記第3のフィルム層、及び前記第4のフィルム層のうちの1つ以上が、その中の弁葉を規定する前記弁葉窓のそれぞれの中に延びている、請求項22に記載の人工弁用フレーム組立体の製造方法。
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JP6445683B2 (ja) | 2018-12-26 |
US20170231757A1 (en) | 2017-08-17 |
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EP3182929B1 (en) | 2023-08-09 |
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WO2016028591A1 (en) | 2016-02-25 |
AU2015305868A1 (en) | 2017-02-23 |
JP2017528205A (ja) | 2017-09-28 |
CN106659567A (zh) | 2017-05-10 |
BR112017003339A2 (pt) | 2017-11-28 |
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CA2956402C (en) | 2020-08-25 |
AU2018282323A1 (en) | 2019-01-17 |
CA2956402A1 (en) | 2016-02-25 |
AU2015305868B2 (en) | 2018-09-20 |
CN106659567B (zh) | 2019-06-14 |
AU2018282323B2 (en) | 2020-08-06 |
US20190247185A1 (en) | 2019-08-15 |
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