JP6392778B2 - 人工心臓弁リーフレットにおける曲げ特性の幾何学的制御 - Google Patents
人工心臓弁リーフレットにおける曲げ特性の幾何学的制御 Download PDFInfo
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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
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- 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
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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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- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
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- A61F2230/00—Geometry of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof
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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
- 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
- A61F2230/0017—Angular shapes
- A61F2230/0026—Angular shapes trapezoidal
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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
- A61F2240/00—Manufacturing or designing of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof
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Description
本願は、2012年12月19日に出願された米国特許仮出願第61/739,721号明細書に対する優先権を主張するものであり、その全体が参照により本明細書に援用される。
図1Aは、一実施形態による弁100の側面図である。図1Bは図1Aの弁100の斜視図である。図2は、図1Aの弁100を長手方向に切断して広げ、概して管形状の弁100の要素をより明瞭に示す側面図である。図3A、3Bは、それぞれ開放構成時と閉鎖構成時の図1Aの弁100の軸線方向図である。図1A、1B、3Bでは、特徴物を見やすくするためにリーフレット140が少し開いた状態を図示しているが、弁100が完全に閉じた状態では、下流の流体圧力の影響下でリーフレット140の自由縁142同士が接合し、その結果、弁が閉じて、下流の血液が弁を介して逆流するのを阻止するものと理解される。
図1A〜図2を参照すると、リーフレットフレーム130は概ね管状の部材である。リーフレットフレーム130は、リーフレットフレーム第1端121aと、リーフレットフレーム第1端121aの反対側にあるーフレットフレーム第2端121bとを有する。図3Aに示すように、リーフレットフレーム130は、リーフレットフレーム外面126aと、リーフレットフレーム外面126aとは反対側のリーフレットフレーム内面126bとを備える。リーフレットフレーム130は、当技術分野でステントとして知られる構造物を備えてよい。ステントとは、経カテーテルにより経皮的に解剖学的組織に送達するのに適した小さな直径を有し、且つ解剖学的組織内での展開時に大きな直径に拡張することのできる、管状の部材である。種々の設計及び材料特性を有するステントが当技術分野において周知である。
外科的移植に適した弁100の実施形態によれば、弁100は、図4Bが示すように、一実施形態のリーフレットフレーム外面の周囲にある縫合カフ170をさらに備える。縫合カフ170は、植え込み部位に連結するための縫合糸を受け取る構造を提供するように作用できる。縫合カフ170は、任意の適切な材料(例えばダブルベロアポリエステルが挙げられるが、これに限定されない)を含んでよい。リーフレットフレーム130の外側の縁部分の周りに縫合カフ170を配置してよい。縫合カフは当技術分野において公知である。
フィルム160は、生体適合性の概して任意のシート状材料であり、実施形態に従ってリーフレット140をリーフレットフレーム130に連結するように構成される。「フィルム」という語は、特定目的に適した1つ以上の生体適合性材料の総称として使用されるものと理解される。リーフレット140もフィルム160で構成される。
図1Aと図2を参照すると、各リーフレット窓137にフィルム160等の生体適合性材料が提供され、フィルム160は、リーフレット窓側部133の一部分と連結して、リーフレット140を画定する。一実施形態によれば、各リーフレット140は、リーフレット自由縁142とリーフレット基部143とを画定する。後述するように、複数の実施形態のリーフレット基部構成を提供できることが想定される。一実施形態によれば、フィルム160は、リーフレット窓側部133の一部分とリーフレット窓基部134に連結し、この場合、リーフレット140はリーフレット窓側部133の当該部分とリーフレット窓基部134で画定される。
リーフレット140を構成する生体適合性材料は、充分な柔軟性と可撓性を有する、生体適合性の任意の生物組織材料又は合成材料(例えば生体適合性ポリマー)を含んでよい。一実施形態では、リーフレット140は、「複合材料」と称される、エラストマーと組み合わされた生体適合性ポリマーを含む。一実施形態による材料は、フィブリル配列内に複数の空間を含む延伸フルオロポリマー膜と、エラストマー材料とを含む複合材料を含む。本開示の範囲を逸脱することなく、複数の種類のフルオロポリマー膜と、複数の種類のエラストマー材料とを組み合わせて積層物を形成できることを理解すべきである。また、本開示の範囲を逸脱することなく、エラストマー材料に複数のエラストマーを含めてよく、複数の種類の非エラストマー成分(例えば無機充填剤、治療剤、放射線不透過性マーカー、又は同種のもの)を含めてよいことも理解すべきである。
一実施形態によれば、植え込み時に左心室の索枝を覆わないことにより、大動脈弁置換術で遭遇し得るような心臓刺激伝導系との干渉を防止するように弁100を構成できる。例えば、弁100の長さを約25mm未満又は約18mm未満にしてよい。また、弁100のアスペクト比(弁100の長さと拡張時の機能的直径との間の関係を表す比率)を1未満にしてよい。しかしながら、弁100は任意の長さで構成してよく、より一般的には所望の寸法で構成してよい。
図4Aを参照すると、一実施形態では、弁送達システム500は、上述のような折り畳み構成と拡張構成を有する弁100と、細長い可撓性カテーテル480(例えばバルーンカテーテル)とを備え、カテーテルを介して弁100を展開するように構成される。カテーテル480は、弁100を拡張させ、且つ/又は必要に応じて弁100を微調整して確実に配置させるためのバルーンを備えてよい。脈管構造を通じて送達するために、弁100をカテーテル480の遠位部分に取り付けてよい。折り畳み構成時の弁をカテーテル480上に保持する目的で、弁送達システムは、経カテーテル弁100にぴったりとフィットする取り外し可能シース(図示せず)をさらに備えてよい。
上記実施形態の弁100を、経カテーテル手法を用いる代わりに外科的に植え込んでもよいと理解される。外科的に植え込まれる弁100の実施形態は、上記実施形態と実質的に同じであり得るが、一実施形態によれば、図4Bに示す通り、リーフレットフレーム外面126aに隣接して縫合カフが追加される。縫合カフは、当技術分野において周知であり、弁100を植え込み部位(例えば組織開口部)に連結するための縫合糸を受け取る構造を提供するように作用できる。縫合カフは、任意の適切な材料(例えばダブルベロアポリエステルが挙げられるが、これに限定されない)を含んでよい。縫合カフは、リーフレットフレーム130の基部の周囲に配置してもよく、リーフレットフレームが従属する弁の周囲に配置してもよい。
本明細書に記載の実施形態は、本明細書に記載の実施形態の弁100を製作する方法にも関連する。円筒形のマンドレル710を使用して各種実施形態を製作できる。図6を参照すると、マンドレル710は、表面にリーフレットフレーム130を受け入れるように作用できる構造形態を含む。弁100の製作方法の一実施形態は、マンドレル710の周囲に第1フィルム層160(例えば、本明細書に記載の複合材料)を管形状に形成するステップと、図6に示すように第1フィルム層160にリーフレットフレーム130をかぶせるステップと、リーフレットフレーム130の上に第2フィルム層160を形成するステップと、組立体を熱で固定するステップと、図7A、7Bに示すように切断マンドレル712の上に組立体を受け入れるステップと、リーフレット窓137内のリーフレット窓上部を横切ってフィルム160を切断するステップとを含む。
EOA(cm2)=Qrms/(51.6*(ΔΡ)1/2)
(式中、Qrmsは収縮期/拡張期流量(cm3/s)の二乗平均平方根、ΔΡは収縮期/拡張期平均血圧低下(mmHg)である。)
Claims (28)
- 概ね管状の形状を有し、複数のリーフレット窓を画定する、リーフレットフレームと、
前記リーフレットフレームに連結され、前記リーフレット窓の各々から広がる少なくとも1つのリーフレットを画定するフィルムと
を備える人工弁であって、
前記リーフレット窓の各々は、2つのリーフレット窓側部と、リーフレット窓基部と、リーフレット窓上部とを含み、各リーフレットは、2つのリーフレット側部と、リーフレット基部と、前記リーフレット基部の反対側にある自由縁とを有する二等辺四辺形の形状を有し、前記2つのリーフレット側部は前記リーフレット基部から分岐しており、前記リーフレット基部は平らであり、前記リーフレット基部は前記窓基部に連結され、前記2つのリーフレット側部の各々は前記2つの窓側部の一方に連結され、各リーフレットは、2つの側部領域と、前記2つの側部領域の間にある中央領域とを有し、前記中央領域は、前記2つの側部領域とは異なる形状を有し、前記中央領域は平面状である、人工弁。 - 前記2つの側部領域と前記中央領域は平面状である、請求項1に記載の人工弁。
- 前記中央領域は平面状であり、前記2つの側部領域は、各々の形状に球状又は円筒状の構成部分を有する、請求項1に記載の人工弁。
- 前記中央領域は、中央領域両側の二辺と、前記リーフレット基部と、前記リーフレット自由縁とで画定される二等辺三角形の形状で画定され、前記中央領域両側の二辺は、前記リーフレット基部から集まり、前記2つの側部領域の各々は、三角形の形状を有し、前記中央領域両側の辺の一方と、前記リーフレット側部の一方と、前記リーフレット自由縁とで画定される、請求項1に記載の人工弁。
- 前記人工弁が非加圧条件下で閉位置にある時、前記2つの側部領域の各々は平面状である、請求項4に記載の人工弁。
- 前記リーフレットフレームは、リーフレットフレーム第1端と、前記リーフレットフレーム第1端の反対側にあるリーフレットフレーム第2端とを備え、前記リーフレット窓は、二次元の二等辺四辺形を前記管形状の前記リーフレットフレームに巻き付けることにより少なくとも部分的に決定される形状を有し、前記二等辺四辺形は、基部と、前記基部から分岐する2つの辺とを有し、隣り合う二等辺四辺形からの辺が、前記リーフレットフレーム第2端で交わる、請求項1に記載の人工弁。
- 前記隣り合う二等辺四辺形が交わる場所から伸びて、前記リーフレットフレーム第2端まで及ぶ長さを有する垂直要素をさらに備える、請求項6に記載の人工弁。
- 前記フィルムは、前記リーフレットフレームの外面に連結し、前記フィルムは、前記リーフレット窓の各々から広がる前記リーフレットを画定する、請求項1に記載の人工弁。
- 前記フィルムは、前記リーフレットフレームの内面に連結し、前記フィルムは、前記リーフレット窓の各々から広がる前記リーフレットを画定する、請求項1に記載の人工弁。
- 前記フィルムは、前記リーフレットフレームの内面と外面に連結し、前記フィルムは、前記リーフレット窓の各々から広がる前記リーフレットを画定する、請求項1に記載の人工弁。
- 前記リーフレットフレームは、三角形の形状を有する相互に接続された3つのリーフレット窓を画定する、請求項1に記載の人工弁。
- 1つのリーフレット窓の一方のリーフレット窓側部が、隣接するリーフレット窓の一方のリーフレット窓側部と相互に接続される、請求項1に記載の人工弁。
- 前記リーフレットフレームは、間隔を空けて配置された複数のリーフレット窓を備え、前記リーフレット窓の各々は、前記リーフレット窓間の基部要素により相互に接続される二等辺三角形の形状を画定し、各リーフレット窓側部は、1つの三角形の一辺と、隣接する三角形の一辺とで画定され、各リーフレット窓基部は、前記基部要素で画定される、請求項1に記載の人工弁。
- 前記リーフレットフレームは、間隔を空けて配置され相互に接続した複数のリーフレット窓を含み、各リーフレット窓は二等辺四辺形を画定し、各リーフレット窓側部は、前記二等辺四辺形の前記窓側部で画定され、各リーフレット窓基部は、基部要素で画定される、請求項1に記載の人工弁。
- 経カテーテル送達用に折り畳み構成と拡張構成とを含む、請求項1に記載の人工弁。
- 前記リーフレットはポリマー材料を含む、請求項1に記載の人工弁。
- 前記リーフレットは積層物を含む、請求項16に記載の人工弁。
- 前記積層物は、1層より多い層のフルオロポリマー膜を有する、請求項17に記載の人工弁。
- 前記リーフレットは、少なくとも1層のフルオロポリマー膜を有するフィルムを含み、前記フルオロポリマー膜は、複数の孔と、前記少なくとも1層のフルオロポリマー膜の前記孔の全部に存在するエラストマーとを有する、請求項1に記載の人工弁。
- 前記フィルムは、80重量%未満のフルオロポリマー膜を含む、請求項19に記載の人工弁。
- 前記エラストマーはパーフルオロアルキルビニルエーテルを含む、請求項20に記載の人工弁。
- 前記エラストマーは、テトラフルオロエチレンとパーフルオロメチルビニルエーテルのコポリマーを含む、請求項19に記載の人工弁。
- 前記フルオロポリマー膜はePTFEを含む、請求項19に記載の人工弁。
- 複数のリーフレット窓を画定する、概ね管形状のリーフレットフレームを提供することと、
フィルムを提供することと、
前記リーフレットフレームの周りに前記フィルムを巻き、複数層の前記フィルムを、前記リーフレット窓の各々から広がる少なくとも1つのリーフレットを画定する別のフィルム層に接触させることと、
前記フィルムの層を互いに接着させ、且つ前記リーフレットフレームに接着させることと
を含む、請求項1に記載の人工弁の形成方法であって、
前記リーフレット窓の各々は、2つのリーフレット窓側部と、リーフレット窓基部と、リーフレット窓上部とを含み、
各リーフレットは、2つのリーフレット側部と、リーフレット基部と、前記リーフレット基部の反対側にある自由縁とを有する二等辺四辺形の形状を有し、前記2つのリーフレット側部は前記リーフレット基部から分岐しており、前記リーフレット基部は平らであり、前記リーフレット基部は前記窓基部と連結し、前記2つのリーフレット側部の各々は前記2つの窓側部の一方と連結して、概ね環状の支持構造を提供する、
人工弁の形成方法。 - リーフレットを提供することは、間隔を空けて配置された複数のリーフレット窓を提供することを含み、前記リーフレット窓の各々は、前記リーフレット窓間の基部要素により相互に接続される二等辺三角形の形状を画定し、各リーフレット窓側部は、1つの三角形の一辺と、隣接する三角形の一辺とで画定され、各リーフレット窓基部は、前記基部要素で画定される、請求項24に記載の人工弁の形成方法。
- リーフレットを提供することは、間隔を空けて配置された複数のリーフレット窓を提供することを含み、前記リーフレット窓の各々は二等辺四辺形を画定し、各リーフレット窓側部は、前記二等辺四辺形の前記窓側部で画定され、各リーフレット窓基部は、基部要素で画定される、請求項24に記載の人工弁の形成方法。
- 前記リーフレットフレームの周りに前記フィルムを巻くことは、前記リーフレットフレームの内面の周りに第1フィルムを巻くことと、前記リーフレットフレームの外面の周りに第2フィルムを巻くこととを含み、前記リーフレットは、前記リーフレット窓において互いに接着する前記第1フィルムと前記第2フィルムとによって画定される、請求項24に記載の人工弁の形成方法。
- 各リーフレットが、前記リーフレット基部と前記自由縁との間に交差ひだがないことにより特徴付けられる、請求項1に記載の人工弁。
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US13/835,988 US10966820B2 (en) | 2012-12-19 | 2013-03-15 | Geometric control of bending character in prosthetic heart valve leaflets |
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JP7227240B2 (ja) | 2017-10-31 | 2023-02-21 | ダブリュ.エル.ゴア アンド アソシエイツ,インコーポレイティド | 人工心臓弁 |
-
2013
- 2013-03-15 US US13/835,988 patent/US10966820B2/en active Active
- 2013-11-05 CN CN201380066483.9A patent/CN104884000B/zh active Active
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US11950999B2 (en) | 2012-07-25 | 2024-04-09 | Edwards Lifesciences Corporation | Everting transcatheter valve and methods |
US11166809B2 (en) | 2012-07-25 | 2021-11-09 | W. L. Gore & Associates, Inc. | Everting transcatheter valve and methods |
US11896481B2 (en) | 2012-12-19 | 2024-02-13 | Edwards Lifesciences Corporation | Truncated leaflet for prosthetic heart valves |
US11872122B2 (en) | 2012-12-19 | 2024-01-16 | Edwards Lifesciences Corporation | Methods for improved prosthetic heart valve with leaflet shelving |
JP2019103821A (ja) * | 2012-12-19 | 2019-06-27 | ダブリュ.エル.ゴア アンド アソシエイツ,インコーポレイティドW.L. Gore & Associates, Incorporated | 人工弁、枠及びリーフレット及びその製造方法 |
US11826248B2 (en) | 2012-12-19 | 2023-11-28 | Edwards Lifesciences Corporation | Vertical coaptation zone in a planar portion of prosthetic heart valve leaflet |
US11065112B2 (en) | 2014-08-18 | 2021-07-20 | W. L. Gore & Associates, Inc. | Frame with integral sewing cuff for prosthetic valves |
US11471276B2 (en) | 2014-09-15 | 2022-10-18 | W. L. Gore & Associates, Inc. | Prosthetic heart valve with retention elements |
US11857412B2 (en) | 2017-09-27 | 2024-01-02 | Edwards Lifesciences Corporation | Prosthetic valve with expandable frame and associated systems and methods |
US11109963B2 (en) | 2017-09-27 | 2021-09-07 | W. L. Gore & Associates, Inc. | Prosthetic valves with mechanically coupled leaflets |
US11986387B2 (en) | 2017-09-27 | 2024-05-21 | Edwards Lifesciences Corporation | Prosthetic valves with mechanically coupled leaflets |
US11090153B2 (en) | 2017-10-13 | 2021-08-17 | W. L. Gore & Associates, Inc. | Telescoping prosthetic valve and delivery system |
US11439502B2 (en) | 2017-10-31 | 2022-09-13 | W. L. Gore & Associates, Inc. | Medical valve and leaflet promoting tissue ingrowth |
US11154397B2 (en) | 2017-10-31 | 2021-10-26 | W. L. Gore & Associates, Inc. | Jacket for surgical heart valve |
US11123183B2 (en) | 2017-10-31 | 2021-09-21 | W. L. Gore & Associates, Inc. | Prosthetic heart valve |
US10987218B2 (en) | 2017-10-31 | 2021-04-27 | W. L. Gore & Associates, Inc. | Transcatheter deployment systems and associated methods |
US11974916B2 (en) | 2017-10-31 | 2024-05-07 | Edwards Lifesciences Corporation | Jacket for surgical heart valve |
US11497601B2 (en) | 2019-03-01 | 2022-11-15 | W. L. Gore & Associates, Inc. | Telescoping prosthetic valve with retention element |
Also Published As
Publication number | Publication date |
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US10966820B2 (en) | 2021-04-06 |
KR20150097756A (ko) | 2015-08-26 |
CA2891825A1 (en) | 2014-06-26 |
ES2640637T3 (es) | 2017-11-03 |
AU2019210640B2 (en) | 2021-01-21 |
CN104884000B (zh) | 2017-07-11 |
EP3241526B1 (en) | 2018-08-29 |
JP2016501100A (ja) | 2016-01-18 |
US20140172078A1 (en) | 2014-06-19 |
AU2013364188A1 (en) | 2015-06-11 |
WO2014099150A1 (en) | 2014-06-26 |
EP2934386A1 (en) | 2015-10-28 |
HK1215151A1 (zh) | 2016-08-19 |
CN104884000A (zh) | 2015-09-02 |
KR102138396B1 (ko) | 2020-07-27 |
CA2891825C (en) | 2018-12-04 |
US20210205074A1 (en) | 2021-07-08 |
EP2934386B1 (en) | 2017-07-26 |
EP3241526A1 (en) | 2017-11-08 |
AU2017200967B2 (en) | 2019-05-02 |
ES2700372T3 (es) | 2019-02-15 |
JP2018198964A (ja) | 2018-12-20 |
AU2017200967A1 (en) | 2017-03-02 |
JP6756785B2 (ja) | 2020-09-16 |
HK1245064B (zh) | 2019-09-27 |
AU2019210640A1 (en) | 2019-08-22 |
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