JP2014507179A - 統合された弁尖を伴う折り畳まれた膜の心臓弁膜尖を含む経皮的にデリバリー可能な心臓弁 - Google Patents
統合された弁尖を伴う折り畳まれた膜の心臓弁膜尖を含む経皮的にデリバリー可能な心臓弁 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
- A61F2/2412—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
- A61F2/2412—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
- 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
- A61F2220/0025—Connections or couplings between prosthetic parts, e.g. between modular parts; Connecting elements
- A61F2220/0075—Connections or couplings between prosthetic parts, e.g. between modular parts; Connecting elements sutured, ligatured or stitched, retained or tied with a rope, string, thread, wire or cable
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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
- 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
Abstract
Description
本発明は医療装置の分野に、そしてより詳細には経皮的にデリバリー可能な心臓弁に関する。
天然の心臓弁、およびより詳細には、大動脈弁は左心室流出路の管状流入構造および心臓の繊維質の「骨組み」の部分である大動脈弁輪状環により画定される弁尖の蝶番点上の弁洞の延長部分の解剖学的接合を通して理想的な開閉形状を与える複雑な形状を有する。
本発明はさまざまな異なる変形または実施形態を含むことが理解されるべきであり、そしてこの概要は限定または全ての包含とは意味されない。この要約はいくつかの実施形態のいくつかの一般的な説明を提供するが、他の実施形態のいくつかのより特定の説明をもまた含み得る。
1つ以上の本発明の上記のおよび他の利点および特徴をさらに明らかにするために、1つ以上の本発明のより詳細な説明は付属の図面中に示されるそれらの特定の実施形態を参照して示される。これらの図面は1つ以上の本発明の典型的な実施形態のみを描写し、そしてそれゆえその範囲の限定とは考えられないことが理解されるべきである。1つ以上の本発明は付属の図面の使用をとおしてさらに特におよび詳細に示されおよび説明される。
少なくとも1つの実施形態において、可動弁尖層および弁尖の軸全長にとってすぐ外側の構造(心臓弁膜尖壁層、フレームまたはその他)は単一の連続した材料片である。
本明細書中に示される全ての実施形態について、「膜」は心臓弁膜尖および弁尖を形成するために好適な材料を含むことが理解されるべきである。したがって、膜シートを形成するために使用され得る特定の材料型について、少なくとも1つの実施形態において、心臓弁膜尖または弁尖部分を形成する膜シートは固定された哺乳類心膜組織またはePTFEの如き合成生体適合材料の如き、生体適合膜の1片の単一層シートを含む。少なくとも1つの実施形態において、その膜シートは人工のカテーテルによりデリバリー可能な心臓弁における使用のために好適な強さおよび耐久性の弁尖材料を作出する組織調製プロセスから作出される。当該出願は2011年9月9日公開のWO2011/109450A2の内容についてその全体が援用される。その膜シートは好ましくは単一の材料片であるが、繋げられた2〜50以上の材料片の如き複数の材料片からなる膜シートが使用され得る。
一般的に図1A〜7Kについて、本明細書中に示される統合された心臓弁膜尖および弁尖構造の各心臓弁膜尖の実施形態は円錐形の縦軸に実質的に垂直な軸に沿って折り畳まれた実質的に平らにされた円錐形である。1つ以上の実施形態において、統合された心臓弁膜尖および弁尖構造は、1つの膜片から形成されるとき、閉多角形パターンから膜の平らなシートを折り畳むことにより容易に実現される。パターンの折り畳みは縫合線をそれらの軸長に沿って整列させ、並列させる。これらは「背骨」を形成する接合された縫合線で一般的な円錐形の心臓弁膜尖を閉じるよう接合され、その「背骨」に沿って心臓弁膜尖が管状フレームの内面にぶつかる。乾燥シート膜から形成されたとき、パターンは偏菱形の底部を有する逆ピラミッドである心臓弁膜尖の形をはじめにもたらし、その形は柔軟な、しなやかな膜で、実質的な円錐形に一致することが理解され得る。実際の使用における折り畳みの弛緩に際して、弁尖の内部の可動性機能部分が心臓弁膜尖洞またはポケットの一体化した壁を形成する外側部分と連続する実質的な円錐形の心臓弁膜尖が実現される。
図1Bの図はテンプレートの折り畳みの実行後の図1Aの再定位された線分および区画を描写する、実質的に完成した折り畳まれた弁尖および心臓弁膜尖構造130を示す視野で、下方(近位方向)および半径方向外向きに見ている。線分111および121は弁尖の可動性機能部分の遠位のフリーの端の左および右半分を形成する。116および126での内側への折り畳みは膜の第1の層の外側の膜の第2の層を形成し、線分112および122は統合された心臓弁膜尖の外壁の遠位のフリーの縁を形成する。統合された心臓弁膜尖および弁尖構造の半径方向に平らにされた形態(すなわち、弁尖の開放作動位置に近似する)において、線分111は112に並列するであろう、そして121は122に並列するであろう。
図1Cおよび1Dについて、部分的に完成した折り畳まれた弁尖および心臓弁膜尖の斜視上面(遠位側)透視図が示される。図1Cおよび1Dにより提供される図は、テンプレートの折り畳みの部分的な実行後の図1Aの再定位された線分および区画を描写する視野で、下方(近位方向)および半径方向外向きに見ている。
図2について、および少なくとも1つの実施形態に従って、長方形よりむしろ多角形である平らなシート膜テンプレート200の平面図が示される。テンプレート200はそれぞれ折り畳み101、116、126、117および127に対応する、折り畳み201、216、226、217および227を含み、折り畳み201、216、226、217および227は、折り畳みの実行により同様の態様で配置され、これは列挙される線分についてもあてはまる。折り畳みパターンは弁尖接合のより遠位に配置される中点を達成する同じ直径のより長い円錐形を形成するよう設計され、そのより長い円錐形の機構は圧負荷に対してより耐性である。パターン寸法は弁の特定の臨床適用に合うように変えられ得る。本明細書中に開示されるテンプレートの実施例は使用可能にする目的のためであり、そして請求項の範囲を限定するものとして解釈されるべきでない。実施例は一般的に円筒形の弁の形状の水平面(短軸)に対して約60度角に配置された心臓弁膜尖円錐壁について示され、一方、図1A〜1Gの長方形のパターンについての角は約45度であった。
図3について、および少なくとも1つの実施形態に従って、テンプレート300の平面図が、折り畳みを完了したときその構造の遠位の外形を延長する追加の区画を伴って、図2のパターン200を含む平らなシート膜について示される。より詳細には、可動弁尖区画のフリーの端は弁の閉鎖作動における弁尖並列の接触領域を増大させるために多角形のまたは曲がったフリーの端を有する区画を伴って遠位に拡張される。さらに、心臓弁膜尖壁区画および折り返し壁区画318および328の遠位の外形はそれぞれ「つまみ」区画318Tおよび328Tにより拡張される。これらの追加の「つまみ」拡張部分は、フレームに心臓弁膜尖および弁尖アセンブリの外壁を取り付けるためのおよび弁尖並列の面「より上の」(により遠位の)折り返し壁を上げるための領域を増大させ、それにより閉鎖作動における心臓弁膜尖の有効な体積をも増加させる。これらの「つまみ」拡張部分は折り畳みの完了および格子フレーム内への始めの取付け後に遠位に配置されまたはそれらの遠位部分は場合により、例えば、フレームの遠位端に巻きつくように312〜313および322〜323に沿って半径方向外側に折り畳まれ得るので、「つまみ」拡張領域318Tおよび328Tはフレームの外側反管腔側面に存在し、そこでそのフレームに結合されたとき、それらは心臓弁膜尖結合の強さを増加する可能性がある。
図4について、および少なくとも1つの実施形態に従って、パターン400の平面図が、延長部分「つまみ」区画412Tおよび422Tが心臓弁膜尖壁区画の遠位拡張部分のみであることを除いてはパターン300と同様の平らなシート膜について示される。この制限は完全に折り畳まれた統合された心臓弁膜尖および弁尖構造の遠位端での膜の拡張部分の二重層を単層に減少し、それにより心臓弁における膜の大きさを減少させ、そうでなければその膜の大きさは経皮/経カテーテルデリバリー適用における使用のための弁の折り畳みおよび圧縮の有効性を不利に制限し得る。
図5A〜5Fについて、テンプレートパターンのまた別の実施形態が示される。特に図5Aについて、テンプレート500の平面図が平らなシート膜について示される。テンプレート500はそれぞれ折り畳み101、116、126、117および127に対応する折り畳み501、516、526、517および527を含み、折り畳み501、516、526、517および527は、折り畳みの実行により同様の態様で配置され、これは同様に列挙される端線分についてもあてはまる。
特に図5Bについて、テンプレート500に従って折り畳まれた始めに折り畳まれた構造510の内面の透視図(すなわち、半径方向外向きに見た図)が示される。501に沿った中心の折り畳みは、切断502が示されるように実行された後、開始される。501、516および526に沿った折り畳みは半径方向内側に(頁の外側へ)開始されることが示され、そして517および527に沿った折り畳みは半径方向外側に(頁の内側へ)開始されることが示される。
少なくとも1つの実施形態に従って、図6は、心臓弁膜尖円錐壁角aが一般的に長方形のテンプレート500の45度を超える点および可動弁尖区画がフリーの端の多角形のまたは曲がった拡張区画604により拡張される点を除いては、テンプレート500と同様である別のテンプレート600の平面図を示す。
図7A〜7Fについて、テンプレートパターンのさらにまた別の実施形態が例示される。特に図7Aについて、テンプレート600と同様であるが、折り畳まれたとき、円錐形の心臓弁膜尖の頂点を形成するであろう三角の区画の頂点733を暴露するためにテンプレートのより低い(近位の)中線部分の区画を切り取られた、別のテンプレート700の平面図が示される。有効に、拡張区画718および728の中線部分は線分U‐Vの所望の長さにより決定される長さまでテンプレート600に関連して除去され、線分U‐Vの所望の長さは、円錐形の心臓弁膜尖の頂点がU‐Vでの折り畳みにより切断され得る長さを決定する。
図8Aは3つの弁尖を有する弁を形成するために以下の説明の3つの単一片の折り畳まれた統合された心臓弁膜尖および弁尖構造を取り付けるための金属格子フレーム910の斜視上面透視図である。そのフレームは複数の支柱部材911ならびにそれぞれ縫合および/または折り畳まれた膜構造の部分を通すための穴および/または溝を有する3つの軸方向に向いた取り付け棒912を備える。各取り付け棒912は1つの単一片の完全に折り畳まれたおよび形成された心臓弁膜尖および弁尖構造730の軸の外側縫合と並列し、およびそれに結合するためのものである。開放フレームの直径D、例えば、19〜35mmは体内への埋め込み後に弁のアセンブリの配置されたおよび機能的な直径を自然に画定する。支柱部材911はフレームの小直径、例えば、3〜7mmへの半径方向の折り畳みおよび圧縮を許容する特定の長さおよび向きのものである。取り付け棒912はフレームの外周長の周りにほぼ等間隔に存在し、そして取り付け棒912の中心から最も近い取り付け棒912の中心までの弧の長さLはおよそ(π×D)/3に等しい。そのように画定され、Lは折り畳み705と706の間の横方向の外周距離をもまた画定し、フレーム910内に取り付けられたとき、適切な大きさの折り畳まれた心臓弁膜尖および弁尖構造の705と706の間に延びる接合された心臓弁膜尖壁区画761および771の部分の外周長に近似する。
図9Aは、つまみがフレームの外(反管腔側)面に固定され、そして結合されるために、溝を付けられた部材923における溝924を通して合わせ目つまみ762および772を受けるような設計のフレーム920の斜視(上面/遠位)透視図を示す。合わせ目つまみを取り付けるおよび結合するためのこのアプローチは弁作動中の弁尖の合わせ目に対する負荷力を、弁尖を直接繋ぐ縫合上にではなく、有利に部材923の長さに沿ってフレームに溝を付けられた部材923上に分布させ、それにより縫合貫通点で材料が破れる危険性を大いに減少させる。フレームは折り畳み717および727に沿って心臓弁膜尖壁区画761および771を接合する中心縫合線732を取り付けるための軸取り付け棒922をさらに備える。フレームは別のようにフレームの金属格子を形成する複数の支柱部材921をさらに備える。
全ての3つの可動弁尖の遠位のフリーの端が弁の閉鎖作動位置に対応する中心に並列された(接合された)位置で示される。図9Eは、心臓弁膜尖および弁尖構造730Aの折り畳み726Aならびに心臓弁膜尖および弁尖構造730Bの716Bの一部が心臓弁膜尖のより下部の(近位の)境界を形成するときの心臓弁膜尖の内面をまた示す。
Claims (34)
- 格子フレームと、
前記格子フレームに結合された2つ以上の統合された心臓弁膜尖および弁尖の折り畳まれた構造であって、それぞれ可動弁尖層および心臓弁膜尖壁層を含むよう折り畳まれた生体適合膜の平らなシートを備え、前記心臓弁膜尖壁層は前記可動弁尖層の半径方向外側に位置付けられ、そして前記心臓弁膜尖壁層は縫合線に沿って前記心臓弁膜尖壁層の並列側を接合することによりさらに形成される、2つ以上の統合された心臓弁膜尖および弁尖の折り畳まれた構造と、を備える、カテーテルにより経皮的に埋め込み可能な人工心臓弁。 - 前記2つ以上の統合された心臓弁膜尖および弁尖の折り畳まれた構造がそれぞれ前記格子フレームにそれらのそれぞれの縫合線に沿って結合される、請求項1に記載のカテーテルにより経皮的に埋め込み可能な人工心臓弁。
- 前記縫合線が前記格子フレームの軸に対して実質的に平行な方向に向けられる、請求項2に記載のカテーテルにより経皮的に埋め込み可能な人工心臓弁。
- 前記2つ以上の統合された心臓弁膜尖および弁尖の折り畳まれた構造のうちの少なくとも1つの統合された心臓弁膜尖および弁尖の折り畳まれた構造を形成する生体適合膜の前記平らなシートが、2つ以上の生体適合膜材料片を含む、請求項1に記載のカテーテルにより経皮的に埋め込み可能な人工心臓弁。
- 格子フレームと、
前記格子フレームに結合された2つ以上の統合された心臓弁膜尖および弁尖の折り畳まれた構造であって、それぞれ平らな折り畳みパターンに従って弁膜尖を含むよう折り畳まれた生体適合膜の平らなシートを備え、前記弁膜尖は縫合線に沿って前記弁膜尖の並列側を接合することによりさらに形成され、そして前記2つ以上の統合された心臓弁膜尖および弁尖の折り畳まれた構造はそれぞれ、前記格子フレームの軸に対して実質的に平行な方向で前記格子フレームにそれらのそれぞれの心臓弁膜尖縫合線に沿って結合される、2つ以上の統合された心臓弁膜尖および弁尖の折り畳まれた構造と、を備える、カテーテルにより経皮的に埋め込み可能な人工心臓弁。 - 前記2つ以上の統合された心臓弁膜尖および弁尖の折り畳まれた構造のそれぞれの2つの遠位の下流の頂点が半径方向外側方向に頂点の折り畳みとして折り畳まれ、そして前記格子フレームに固定されるので、外周方向に隣り合う弁尖の頂点の折り畳みは隣り合い、そして弁尖の合わせ目に対応する点で弁尖並列の程度を画定する、請求項5に記載のカテーテルにより経皮的に埋め込み可能な人工心臓弁。
- 前記2つの遠位の下流の頂点が前記頂点の折り畳みとの整列に沿わない結合により前記格子フレームに固定される、請求項6に記載のカテーテルにより経皮的に埋め込み可能な人工心臓弁。
- 前記弁膜尖の近位の上流の先端を形成する頂点が半径方向外側方向に折り畳まれ、そして前記格子フレームの内部に結合される、請求項5に記載のカテーテルにより経皮的に埋め込み可能な人工心臓弁。
- 前記平らな折り畳みパターンが多角形であり、そして前記心臓弁膜尖が取り付けられたとき、前記心臓弁膜尖の結合の軸線から前記格子フレームまで外周方向外側に拡張し、近隣の心臓弁膜尖の対応する拡張部分に接合され、そして結合されるとき、一体化した内部の内腔の外周方向の完全なシーリング折り返しを形成する、拡張部分を含む、請求項5に記載のカテーテルにより経皮的に埋め込み可能な人工心臓弁。
- 前記平らな折り畳みパターンが多角形であり、そして前記2つ以上の統合された心臓弁膜尖および弁尖の折り畳まれた構造が取り付けられたとき、前記心臓弁膜尖の結合の軸線から前記格子フレームまで外周方向外側に拡張し、各心臓弁膜尖に関連する外周方向の不完全なシーリング折り返し部分を形成する、拡張部分を含む、請求項5に記載のカテーテルにより経皮的に埋め込み可能な人工心臓弁。
- 生体適合膜の別々の管状の折り返しが前記格子フレームの外側の反管腔側表面に結合され、シーリング折り返しを形成する、請求項5に記載のカテーテルにより経皮的に埋め込み可能な人工心臓弁。
- 前記格子フレームが折り畳み式であり、そして拡張可能であり、そして実質的に管状ステント部材として形成される金属合金を含む、請求項5に記載のカテーテルにより経皮的に埋め込み可能な人工心臓弁。
- 前記生体適合膜が処理された哺乳類心膜組織を含む、請求項5に記載のカテーテルにより経皮的に埋め込み可能な人工心臓弁。
- 前記生体適合膜が処理された組織を含まない、請求項5に記載のカテーテルにより経皮的に埋め込み可能な人工心臓弁。
- 前記生体適合膜が合成材料を含む、請求項5に記載のカテーテルにより経皮的に埋め込み可能な人工心臓弁。
- 前記2つ以上の統合された心臓弁膜尖および弁尖の折り畳まれた構造の前記心臓弁膜尖縫合線がそれぞれ前記弁の流動軸に沿って向けられる、請求項5に記載のカテーテルにより経皮的に埋め込み可能な人工心臓弁。
- 前記2つ以上の統合された心臓弁膜尖および弁尖の折り畳まれた構造がそれぞれ少なくともそれらの遠位の下流の端の一部に沿って前記格子フレームの外周部分にさらに結合される、請求項5に記載のカテーテルにより経皮的に埋め込み可能な人工心臓弁。
- 前記2つ以上の統合された心臓弁膜尖および弁尖の折り畳まれた構造が少なくとも前記弁の軸流動方向と整列された合わせ目でない縫合線で前記格子フレームに結合される、請求項5に記載のカテーテルにより経皮的に埋め込み可能な人工心臓弁。
- 格子フレームと、
前記格子フレームに結合された2つ以上の統合された心臓弁膜尖および弁尖構造であって、それぞれ可動弁尖層および心臓弁膜尖壁層を含むよう折り畳まれた生体適合膜の平らなシートを備え、前記弁の閉鎖作動配置に対応する位置に前記可動弁尖層があるとき、心臓弁膜尖‐洞空間の横方向断面積は前記可動弁尖層の遠位端から近位端まで単調に減少する、2つ以上の統合された心臓弁膜尖および弁尖構造と、を備える、カテーテルにより経皮的に埋め込み可能な人工心臓弁。 - 前記心臓弁膜尖壁層が前記可動弁尖層の半径方向外側に位置される、請求項19に記載のカテーテルにより経皮的に埋め込み可能な人工心臓弁。
- 前記心臓弁膜尖壁層が縫合線に沿って前記心臓弁膜尖壁層の並列側を接合することによりさらに形成される、請求項19に記載のカテーテルにより経皮的に埋め込み可能な人工心臓弁。
- 前記弁の閉鎖作動配置に対応する位置に前記可動弁尖層があるとき、前記可動弁尖層の横方向横断長が前記可動弁尖層の遠位端から近位端まで単調に減少する、請求項19に記載のカテーテルにより経皮的に埋め込み可能な人工心臓弁。
- 各統合された心臓弁膜尖および弁尖構造の前記可動弁尖層および前記心臓弁膜尖壁層が単一の生体適合膜連続片である、請求項19に記載のカテーテルにより経皮的に埋め込み可能な人工心臓弁。
- 部分的組み合わせで、患者の血管系における埋め込みのために形成された弁を形成するための格子フレームへの結合のための統合された心臓弁膜尖および弁尖構造であって、
可動弁尖層および心臓弁膜尖壁層を含むよう折り畳まれた生体適合膜の平らなシートであって、前記心臓弁膜尖壁層は縫合線に沿って分けられ、前記可動弁尖層は連続しており、前記統合された心臓弁膜尖および弁尖構造が実質的に平らになるよう加圧されたとき、前記可動弁尖層は前記心臓弁膜尖壁層と並列する、平らなシート、を備える、統合された心臓弁膜尖および弁尖構造。 - 前記統合された心臓弁膜尖および弁尖構造の前記可動弁尖層および前記心臓弁膜尖壁層が単一の生体適合膜連続片である、請求項24に記載の部分的組み合わせ。
- 前記生体適合膜が処理された哺乳類心膜組織を含む、請求項24に記載の部分的組み合わせ。
- 前記生体適合膜が処理された組織を含まない、請求項24に記載の部分的組み合わせ。
- 前記生体適合膜が合成材料を含む、請求項24に記載の部分的組み合わせ。
- 前記統合された心臓弁膜尖および弁尖構造が少なくとも1つの合わせ目つまみをさらに備える、請求項24に記載の部分的組み合わせ。
- 前記少なくとも1つの合わせ目つまみが前記格子フレームの部材内の溝とかみ合うよう形成される、請求項29に記載の部分的組み合わせ。
- 生体適合膜の平らなシートを平らな折り畳みパターンに従って統合された心臓弁膜尖および弁尖の折り畳まれた構造を形成するよう折り畳むことであって、前記折り畳むことは生体適合膜の前記平らなシート内に2つの対角線状の折り畳みを作出することを含み、前記2つの対角線状の折り畳みは前記統合された心臓弁膜尖および弁尖の折り畳まれた構造の心臓弁膜尖壁層から可動弁尖層を分離する、折り畳むこと、を含む、軸流動方向を有する埋め込み可能な弁における使用のための統合された心臓弁膜尖および弁尖の折り畳まれた構造の形成方法。
- 前記2つの対角線状の折り畳みが前記軸流動方向から10〜80度傾く、請求項31に記載の統合された心臓弁膜尖および弁尖の折り畳まれた構造の形成方法。
- 第1のおよび第2の心臓弁膜尖壁折り畳みを形成することをさらに含み、前記心臓弁膜尖壁層が、前記軸流動方向と実質的に平行に向けられた縫合線に沿って前記第1のおよび第2の心臓弁膜尖壁折り畳みの近隣の並列する膜部分を接合することによりさらに形成される、請求項31に記載の統合された心臓弁膜尖および弁尖の折り畳まれた構造の形成方法。
- 複数の統合された心臓弁膜尖および弁尖の折り畳まれた構造を折り畳むことであって、前記複数の統合された心臓弁膜尖および弁尖の折り畳まれた構造のうちの各統合された心臓弁膜尖および弁尖の折り畳まれた構造は平らな折り畳みパターンに従って心臓弁膜尖を形成するよう折り畳まれた生体適合膜の平らなシートを備え、前記心臓弁膜尖は縫合線に沿って前記心臓弁膜尖の並列側を接合することによりさらに形成される、折り畳むことと、
前記複数の統合された心臓弁膜尖および弁尖の折り畳まれた構造のうちの各統合された心臓弁膜尖および弁尖の折り畳まれた構造を格子フレームに結合することであって、前記2つ以上の統合された心臓弁膜尖および弁尖の折り畳まれた構造はそれぞれそれらのそれぞれの縫合線に沿って前記格子フレームの軸に実質的に平行な方向で前記格子フレームに結合される、結合することと、を含む、カテーテルにより経皮的に埋め込み可能な人工心臓弁の形成方法。
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PCT/US2011/064989 WO2012082952A2 (en) | 2010-12-14 | 2011-12-14 | Percutaneously deliverable heart valve including folded membrane cusps with integral leaflets |
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AU2011343755A1 (en) | 2013-06-06 |
CA3027755C (en) | 2021-05-11 |
JP2018075427A (ja) | 2018-05-17 |
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US9737400B2 (en) | 2017-08-22 |
SG191008A1 (en) | 2013-07-31 |
US20210228347A1 (en) | 2021-07-29 |
CA3027755A1 (en) | 2012-06-21 |
JP6691907B2 (ja) | 2020-05-13 |
JP2020114495A (ja) | 2020-07-30 |
SG10201601962WA (en) | 2016-04-28 |
CA2820738A1 (en) | 2012-06-21 |
CN103391756B (zh) | 2016-06-01 |
CN103391756A (zh) | 2013-11-13 |
CA2820738C (en) | 2019-01-15 |
WO2012082952A3 (en) | 2012-09-07 |
US20120185038A1 (en) | 2012-07-19 |
WO2012082952A2 (en) | 2012-06-21 |
US20180185143A1 (en) | 2018-07-05 |
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